Version 5.0.1 ACL TOP Operators Manual EN

ACL TOP Family Operator's Manual
Help ♦ Version 5.0.1 ♦ P/N 29244915 R01 ♦ 2011
Manufacturer EU Authorized Representative

Headquarters Headquarters
Instrumentation Laboratory Company Instrumentation Laboratory SpA
180 Hartwell Road Viale Monza 338
Bedford, MA 01730-2443 U.S.A. 20128 Milan, Italy
Telephone: 1-781-861-0710 Telephone: 39-02-25221
Fax: 1-781-861-1908 Fax: 39-02-2575250
http://www.ilus.com http://www.il-italia.it
®ACL TOP is a registered trademark of Instrumentation Laboratory Co.

© Copyright 2011 Instrumentation Laboratory Co.
All Rights Reserved
This publication and any and all materials (including software) related to the products of IL are of a pro-
prietary nature and are communicated on a strictly confidential basis; they may not be reproduced, recorded,
stored in a retrieval system, transmitted or disclosed in any way or by any means whatsoever, whether elec-
tronic, mechanical through photocopying or otherwise, without IL’s prior written consent.
Information contained herein is believed by IL to be accurate; in any event, no responsibility, whether
expressed or implied, is assumed hereby by IL for or in connection with the use thereof, or for infringement
of any third party rights that might arise therefrom, or from any representation or omissions contained therein.
Table of Contents
Table of Contents i
CHAPTER 1 About This Manual 1
Welcome to Help 1
General Information 1
Important Symbols 3
Hazards 4
CHAPTER 2 General Information 7
General Information Overview 7
Intended Use 8
Symbols 9
Measured Parameters 11
Operating Principles 12
Instrument Description 14
Modules 14
ACL TOP 300 CTS Model 14
ACL TOP 500 CTS Model 15
ACL TOP 700/ TOP 700 CTS Models 15
ACL TOP 700 LAS Model 16
Instrument Safety Covers 17
Power Connector 17
Emergency Stop Button 18
Keypad 18
Laboratory Automation System (LAS) 20
LAS Arm and Probe 20
LAS Probe Aspirating from Sample on the LAS Track 21
Cuvette Loading Area 21
Bar Code Reader 23
Sample Area 24
Diluent Area 26
Reagent Area 28
Probe 29
Incubators 30
Optical Reading Unit 31
System Fluids – Rinse and Clean 31
Fluid Waste 34
Monitor and Volume Control 37
Calibrating the All-in-One CM Monitor Touch Screen 37
All In One Monitor Diagrams 38
Configuring Volume Control on the ELO Touchsystems Entuitive Monitor 40
Instrumentation Laboratory Company i

Table of Contents
Manufacturer 41
Certification 42
CE Certification 42
CSA Certification 42
LOPD (Data Protection Organic Law) 42
Other Certification 43
System Specifications 44
ACL TOP 300 CTS Specifications 45
ACL TOP 500 CTS Specifications 47
ACL TOP 700 and 700 CTS Specifications 49
ACL TOP 700 LAS Specifications 52
Test Performance 55
Typical Precision Performance 55
Interference 61
Analytical Limitations 62
Installing the ACL TOP Instrument 63
Site Requirements 64
Limited Warranty 64
Spatial Requirements 65
Electrical Requirements 67
Actions Upon Delivery 70
Bringing Into Operation 71
Training Requirements 72
Warranty 73
Limitations and Disclaimers 74
CHAPTER 3 User Interfaces 77
User Interfaces 77
Input Devices 78
Touch Screen 78
Mouse 78
Keyboard 78
Bar Code Reader 78
Two-Dimensional Bar Code Reader 78
Push Buttons 79
LIS 79
CD-ROM Drive 79
Output Devices 80
Getting Started 81
Terminology 82
Calibration/NPP 82
Cuvettes 82
Incubators 85
ii Instrumentation Laboratory Company

LAS Terminology 86
Material 88
Optical Reading Unit (ORU) 89
Visual Styles 91
Layout 92
Main Screen 93
ACL TOP Family Software Main Screen 93
Menu Bar 94
Toolbar 98
General Toolbar 98
Operations Toolbar 98
Navigation Toolbar 99
Other Commonly Used Toolbar Icons 100
Icon Tooltips 101
Moving the Toolbars 101
Toolbar Icon Drop-down Menu 101
Working Area 102
Navigation Toolbar 102
Analysis Menu 102
Scrolling 102
Unique Identifiers 102
Status Bar 104
General Log Icon 104
Analyzer Status 104
LIS Status 105
Auto Run Status 105
LAS Status 105
Alarm Buttons 105
Information Panel 107
Time To Completion 107
User ID 107
Security Level 107
Number of Entries 107
Current Date and Current Time 107
Common Functions Overview 108
Logging In 109
Placing Focus 110
Placing Focus on an Item 110
Combinations of Select and Focus 111
Selecting Objects 113
Selecting All the Objects in a List 113
Adding an Item 114
Viewing an Item 115
Instrumentation Laboratory Company iii

Table of Contents
Deleting an Item 116

Sorting Lists 117
Filtering Data 118
Find 119
Save 120
Restore 121
Previous Screen 122
Print 123
Print Screen 124
Run / Auto Run 125
Overview 125
Running Tests on Manually Loaded Samples 126
After Initiating a Test 126
Exporting Data 127
Cancel / Stop / Progress Bar 128
Logging Out 129
Exit 130
CHAPTER 4 Setup 131
Vial Lists 131
Adding a New Vial 131
Material List 132
Accessing the Material List 132
Filtering the Material List 132
Material List Toolbar 132
Material List Actions Menu 133
Material List Table 135
Material Definition 138
Viewing and Adding Material Definitions 138
Configuring Reporting of INR Results 139
Material Definition Actions Menu 140
Material Definition – Toolbar 141
Assigned Values 155
Overview 155
Viewing, Editing, Printing, Exporting Assigned Values 155
Assigned Values for Calibration 156
Assigned Values for QC 157
Test List 158
Accessing, Printing and Exporting the Test List 158
Filtering the Test List 158
Viewing a Test Definition 158
Adding/Creating a User-Defined Test 159
Copying a Test 159
iv Instrumentation Laboratory Company

Deleting a Test Definition 160

Enabling or Disabling a Test 161
Finding a Test 161
Test List Toolbar 162
Test List Actions Menu 162
Test List Screen 163
Test Definition 165
Viewing a Test Definition 165
Defining a New Test 166
Test Definition Operations Toolbar 167
General Information Screen 168
Accessing the General Information screen 168
General Information Actions Menu 169
General Information 170
Assay 171
Manual validation required 171
Enable as Shadow Test 172
Enable as Paired Test 173
Consistency Check 174
Analytical Cycle Definition 175
Overview 175
Adding a Material Load Cycle Definition – for user-defined tests 175
Deleting a Material Load Cycle Definition – for user-defined tests 176
Analytical Cycle Definition Screen Toolbar 176
Analytical Cycle Definition Screen 177
Material/Sample Load Cycle Definition Screen 181
Sample Pre-Dilution 188
Overview 188
Accessing the Sample Pre-Dilution Screen 188
Sample Pre-dilution screen 189
General Tab 190
Sample/Mixture Tab 192
Diluent Tab 194
Alternative Pre-Dilution 195
Overview 195
Accessing the Alternative Pre-dilution Screen 195
Alternative Pre-dilution Screen 196
Data Reduction Parameters 198
Configuring Data Reduction Parameters for the Primary Wavelength 198
Primary Wavelength 198
Wavelength Definition 200
Overview 200
Accessing the Wavelength definition screen 200
Wavelength Definition screen 201
Raw Data Checks 204
Instrumentation Laboratory Company v

Table of Contents
Overview 204
Accessing the Raw Data Checks screen 204
Raw Data Checks screen 205
Normalized Data Checks 211
Overview 211
Accessing the Normalized Data Checks Screen 211
Normalized Data Checks screen 212
Baseline Check Tab 214
Endpoint Check Tab 215
Multiple Threshold Check Tab 216
Primary Algorithm 218
Accessing Primary Algorithm Parameters 218
Primary Algorithm Screen 218
Enable Primary Algorithm 218
Endpoint Algorithm 219
Linear Kinetic Algorithm 219
Linear Kinetic Algorithm screen 220
Threshold Algorithm 224
First and Second Derivative Algorithms 227
Delta Algorithm 237
Delta Second Derivative Tab 239
Final Minus Initial Algorithm 240
Statistics Algorithm 243
Secondary Algorithm 245
Result Unit Definition 246
Accessing the Result Unit Definition screen 246
Viewing and Editing Measured Units 246
Deleting a Result Unit 247
Result Unit Definition Screen 250
Calibration Setup 256
Accessing the Calibration Definition screen 256
Accessing the Pre-diluted Calibrators screen 257
Calibration Definition Screen 258
Enable calibration 258
General Tab 259
Frequency Tab 261
DR Parameters Tab 262
Math Model Tab (or Math Model High) 263
Math Model Low Tab 266
Automatic Dilution Screen 267
General Tab 267
Calibrator Tab 275
Diluent Tab 276
Pre-diluted Calibrators Screen 277
Column Headings 277
vi Instrumentation Laboratory Company

Configuring Factor Parallelism 279

Overview 279
Factor Parallelism Testing Options 280
Factor Parallelism Criteria 284
IL Tests Default Criteria 285
Determining Factor Activity Using Factor Parallelism (multiple sample dilutions) 287
Examples of Factor Parallelism results 289
Parallelism Setup 291
Overview 291
Viewing and Editing the Parallelism Definition Screen 291
Parallelism Definition screen 292
Analytical Cycle Tab 293
Data Reduction Tab 294
Normal Pool Plasma Setup 298
Test Definition – Normal Pool Plasma Screen 299
General Tab 300
Frequency Tab 302
Rerun Rules Setup 304
Overview 304
Consistency Check 311
Performing a Consistency Check 311
Consistency Check Window 311
QC List 312
Accessing the QC List 312
QC List Toolbar 312
QC List screen 313
QC Setup Definition 314
Accessing the QC Setup Definition screen 314
QC Setup Definition screen 314
Test Profiles List 321
Accessing the Test Profiles List 321
Configuring the Standard Test Profile 323
Test Profiles List Toolbar 323
Test Profiles List Screen 324
QC Profiles List 325
Accessing the QC Profiles List 325
QC Profiles List Toolbar 325
QC Profiles List Column Descriptions 326
Defining QC Profiles 327
Creating a QC Profile 327
Viewing a QC Profile 328
Editing a QC Profile 328
Deleting a QC Profile 328
Reflex Rules 330
Instrumentation Laboratory Company vii

Table of Contents
Creating a Reflex Rule 330

Viewing or Editing a Reflex Rule 330
Reflex List Operations Toolbar 331
Reflex List 331
Auto-Validation Setup 334
Configuring Auto-Validation 334
Revision History Report 338
Importing and Exporting Definitions 339
Overview 339
Exporting Definitions 340
Importing Definitions 341
Field Descriptions 343
Global Definitions Setup 344
Setting Up Global Definitions 344
Global Definitions Setup Screen 344
Bar Code Definitions Setup 350
Configuring Bar Code Reading 350
Bar Code Definitions screen 350
Bar Code Label Placement 353
LIS Configuration 354
Overview 354
Configuring Communication with an LIS 354
Performing a Manual LIS Query 354
Host Communications Configuration Tab 355
ASTM-1394 Configuration Tab 357
Communications Configuration Tab 358
Sender List 359
Accessing the Sender List 359
Sender List 359
LAS Overview 360
Definition 360
Sample Workflow 360
Prioritization of Samples 361
Communication 362
Hazards and Warnings 362
LAS Terminology 362
LAS Configuration 363
Accessing the LAS Configuration screen 363
LAS Configuration tab 363
LAS Interface Module Configuration tab 366
LAS Tube Types tab 366
System Security 367
User Security List 368
Accessing the User Security List 368
viii Instrumentation Laboratory Company

User Security List screen 368

Adding and Editing Users 369
Adding a New User 369
Unlocking a User 370
Editing a User 370
User Security Screen 372
Software Access Screen 374
Accessing the Software Access Screen 374
Formatting Reports 375
Configuring Reports 375
Laboratory Header Tab 376
Demographic Tab 377
Footer Tab 377
AutoPrint Setup Tab 378
Display Overview 379
Sample List Display Settings 380
Test Programming Window 381
Configuring the Test/Profiles Programming Window 381
Material Programming Window 382
Configuring the Material Programming Window 382
Setup Language 384
CHAPTER 5 Preparing the System 385
Additional Preparation 385
Material Identification 386
Manually Identifying Offline Rack Material 386
Manually Identifying Inserted Rack Material 387
Automatic Material Identification – Using the Bar Code Reader 388
Manual Material Identification – Using the Offline Rack 388
Bar Code Reader 390
TOP 300 CTS Bar Code Reader 391
TOP 500 CTS Bar Code Reader 391
TOP 700 Bar Code Reader 392
2D Bar Code Scanner 393
Overview 393
Setup 393
Using the 2D Bar Code Scanner 393
Verified Barcode Material Data dialog box 394
Reaction Cuvettes 397
Rinse Fluid 398
Overview 398
Changing the Rinse Fluid 398
Clean Fluid 400
Instrumentation Laboratory Company ix

Table of Contents
Overview 400
Changing the Clean Fluid 401
Fluid Waste 402
Overview 402
Reagents 404
Calibrators and NPP 405
Quality Controls 406
Samples 407
Sample Containers and Adapters 408
Sample Adapters for Open and Closed Tubes 408
Sarstedt Closed Tube Sample (CTS) Rack and Adapters 410
Validated Uncapped Sample Containers 412
Validated Uncapped Sample Containers for LAS – Track Only 414
Validated Capped Sample Containers for CTS – Piercing Mode Enabled 415
Validated Capped Sample Containers for CTS – Lower Z Piercing Mode Enabled 416
Sample Containers Not Recommended for CTS 417
Diluents 419
Restriction Map 420
Overview 420
Accessing the Restriction Map 420
TOP 500 CTS Restriction Map 423
TOP 700 Restriction Map 424
TOP 700 LAS Restriction Map 425
Closed Tube Sampling 426
Overview 426
Enabling/Disabling CTS Mode 427
Closed Tube Sampling (CTS) Probe 428
Sarstedt Closed Tube Sample (CTS) Rack and Adapters 431
Sample Area 433
Reagent Area 434
Accessing the Reagent Area and Rack Details 434
Programming Non-Bar Coded Reagents Using the Offline Rack 435
Viewing On-board Materials 436
Reagent Area Operations Toolbar 437
Reagent Rack Details Operations Toolbar 438
Reagent Area Screen 439
Reagent Rack Details Screen 443
Offline or Virtual Rack 446
Diluent Area 447
Accessing the Diluent Area 447
Diluent Area 448
Diluent Rack Details 449
Reagent/Diluent Area 450
x Instrumentation Laboratory Company

Overview 450
Accessing the Reagent/Diluent Area and Rack Details 450
Programming Non-Bar Coded Reagents Using the Offline Rack 451
Reagent/Diluent Area Operations Toolbar 452
Reagent Rack Details Operations Toolbar 453
Reagent/Diluent Area Screen 455
Reagent Rack Details Screen 461
Offline Racks 464
Diluent Rack Details Screen 465
Test Feasibility 467
Accessing The Test Feasibility List 467
Feasibility Test List window 468
Test Feasibility List Tab 468
QC Feasibility List Tab 472
Refresh/Close 473
CHAPTER 6 Starting and Stopping the Instrument 475
Starting and Stopping Overview 475
Starting the Instrument 476
Shutting Down the Instrument 477
Emergency Stop 478
Controlled Stop 479
Resume Auto Run 481
Recovery 482
Performing a Recovery Operation 482
Performing a Forced Recovery 482
CHAPTER 7 Calibration 485
Calibration Details 485
Overview 485
Viewing Calibration Curves 487
Deleting a Calibration Point Value 487
Printing and Exporting a Calibration Report 488
Calibration Details screen 490
Calibration Curve Tab 490
Calibration Status List 497
Performing a Calibration 499
CHAPTER 8 Normal Pool Plasma 501
NPP Status Details 501
Overview 501
Reviewing NPP Results 501
Recalculating NPP Test Results 502
Printing an NPP List Report 502
Printing an NPP Results Report 503
Exporting a Report 503
Instrumentation Laboratory Company xi

Table of Contents
NPP Status List Screen 504

Performing a Normal Pool Plasma Measurement 506
Programming an NPP in the NPP Details screen 506
Programming an NPP from the Sample Rack Details screen 507
Automatic NPP 507
CHAPTER 9 Quality Control 509
QC Overview 509
QC Performed on Alternate Lots 509
Activating an Alternate Lot 509
QC Results List 511
Accessing the QC Results List 511
QC Results List 511
QC Test Status List 513
Accessing the QC Test Status List 513
QC Test Status List screen 513
Performing a Quality Control Test 515
Programming QC in the QC Test Status List 515
Programming QC in the Sample Rack Details screen 518
Enabling Automatic QC 519
Programming a QC Profile 519
Reviewing QC Results 520
Viewing and Filtering the QC Results 520
Viewing QC Statistics in Chart and Grid View 521
Adding or Viewing Comments 522
Tracking QC Information 522
Viewing Reaction Curves 522
Omitting Points 523
Restoring Points 523
Purging Data 524
Setting Statistics as Target 524
Activating an Alternate Lot 524
Uploading results to the LIS 525
Filtering Results for Printing Reports 525
Printing QC Test Status Reports 531
Exporting Reports 531
QC Statistics Screen 531
Active Lot Tab 533
Chart View 535
Grid View 538
Grid Plus Chart View 540
Multi Chart View 541
CHAPTER 10 Sample Analysis 543
Sample Collection and Storage 543
Plasma Collection 543
Plasma Separation 543
xii Instrumentation Laboratory Company

Sample Area 544

Accessing the Sample Area 544
Sample Area Operations Toolbar 546
Sample List Toolbar 547
Sample Area Screen 548
Restriction Map 552
Racks 556
Track Control Panel 558
Bar Code Reader Indicator 558
LAS Cuvette Holding Area 560
LAS Cuvette Holding Area Operations Toolbar 561
Sample Rack Details 565
Accessing Sample Rack Details 565
Deselecting Tests 566
Sample Area Toolbar 566
Sample Rack Details Operations Toolbar 567
Sample Rack Details screen 569
Tests and Profiles Window 572
Rack Summary Information 573
Programming Bar Coded Samples 574
Programming Bar Coded Samples Using an LIS (Host) 574
Programming Bar Coded Samples After Loading the Rack, Without an LIS 575
Programming Non-Bar Coded Samples 576
Programming Non-Bar Coded Samples Using the Offline Rack and an LIS (Host) with Automatic
Downloading Enabled 576
Programming Non-Bar Coded Samples After Inserting the Rack, Using an LIS with Host Query Ena-
bled 577
Programming Non-Bar Coded Samples After Inserting the Rack, Without Using an LIS 578
Programming Non-Bar Coded Samples Using the Offline Rack, Without Using an LIS 579
Reviewing Sample Status 580
Reviewing Test Results 581
Recalculating Test Results 581
Validating a Single Completed Test Result 582
Validating All Completed Test Results for a Sample 582
Uploading a Single Completed Test Result to the LIS 583
Uploading All Completed Test Results for a Sample to the LIS 584
Deleting Results 584
Printing Sample Results Reports 585
Printing Sample Results Detailed Reports 586
Printing Patient Reports 587
Exporting Reports 588
Sample List 589
Viewing Sample Details 589
Selecting and Placing Focus on Samples 590
Instrumentation Laboratory Company xiii

Table of Contents
Adding and Removing Tests Associated with a Sample 591

Validating a Single Completed Test Result 592
Validating All Completed Test Results for a Sample 592
Uploading a Single Completed Test Result to the LIS 593
Uploading All Completed Test Results for a Sample to the LIS 594
Finding a Sample ID 594
Filtering Selected Samples by Test Code 595
Changing the Sample List Display Settings 596
Configuring Sample List Display Settings 597
Actions Menu 599
Sample List Toolbar 602
Sample List Screen 603
Sample List Columns 605
Test Information Columns 608
Time to Completion 610
Sample Details 611
Viewing Sample Details 611
Viewing Parallelism Details 611
Test Information Tab 612
Patient Demographics Tab 614
Test Details 615
Viewing Test Details 615
Printing and Exporting a Parallelism Report 616
Printing the Clot Curve 617
Test Details Screen 618
Parallelism Test Details Screen 620
Clot Curve Analysis 621
Overview 621
Configuring, Viewing and Analyzing Derivative Curves – PT and APTT examples 621
Clot Curve Analysis 625
Conclusion 627
Results Statistics 628
Viewing Results Statistics 628
Results Statistics Window 630
Test Counters Statistics 631
Accessing the Test Counters Statistics Windows 631
Simple Test Counter Statistics 631
Detailed Test Counter Statistics 632
Sample List Filter 634
Sample Filters 1 Tab 635
Set of Filters 2 Tab 637
Set of Filters 3 Tab 639
Test Filters 1 Tab 640
All Samples 641
CHAPTER 11 Analyzer Status 643
xiv Instrumentation Laboratory Company

Analyzer Status Indicators 643

CHAPTER 12 Alarms and Troubleshooting 645
Alarm Messages 645
Accessing Alarm Messages 645
Material Alarms 646
Job Frequency Alarms 660
QC Alarms 661
Maintenance Alarms 662
Analyzer Alarms 664
External Communications Alarms 729
Setup Alarms 735
Other Alarms 739
Popup and Message Windows 740
Alarm Buttons 753
Warning Alarms 753
Error Alarms 753
No New Alarms 753
Alarm Buttons in the Status Bar 753
Troubleshooting Other Problems 755
Data Flags 757
Data Flag Groups 757
Data Flags List 758
Accessing Data Flags 775
Sample List 775
Sample Details Screen 775
Test Details Screen 776
Calibration Details Screen 776
QC Statistics Screen 777
NPP Details Screen 777
CHAPTER 13 System 779
Maintenance Schedule 779
Daily Maintenance 779
Weekly Maintenance 779
Monthly and Quarterly Maintenance 779
Annual and Semi-Annual Maintenance 780
As Needed Maintenance 780
By Number of Piercings Maintenance 780
Good Laboratory Practice 781
Maintenance List 782
Accessing Maintenance Activities 782
Maintenance Actions Menu 784
Maintenance Activity Table 788
Viewing and Configuring a Maintenance Activity 790
Viewing and Editing a Maintenance Activity 790
Instrumentation Laboratory Company xv

Table of Contents
Adding a Maintenance Activity 790

Configuring a Warning Threshold 790
Maintenance Activity Configuration dialog box 791
Adding a New Maintenance Activity 794
Adding a New Manual Maintenance Activity 794
Maintenance Activity Configuration dialog box 794
Deleting a Maintenance Activity 796
Maintenance Definitions 797
Automatic Fluidic Line Priming Cycle 797
Automatic Routine Clean for All Probes 798
Clean Cuvette Waste Drawer 798
Clean Deep Wash and Clean Cup Area 799
Clean Rack Areas 799
CTS Foot Cleaning 799
Cuvette Evacuation Cycle 799
Empty Cuvette Waste – Daily (Manual Activity) 800
Empty Waste Fluid – Daily (Manual Activity) 800
Enhanced Clean for All Probes 801
Enhanced Clean for LAS Probe 802
Enhanced Clean for Reagent 1 and Reagent 2 Probes 803
Enhanced Clean for Reagent 1 Probe 804
Enhanced Clean for Reagent 2 Probe 805
Enhanced Clean for Reagent Probe 806
Enhanced Clean for Sample Probe 807
Foot and Probe Inspection 807
Replace CTS Filter and clean Clean Cup Area 808
Replace CTS Piercer 808
Replace LAS Syringe 808
Replace LAS Syringe Tip 809
Replace Reagent 1 and Reagent 2 Syringe Tips 809
Replace Reagent 1 Syringe 809
Replace Reagent 1 Syringe Tip 809
Replace Reagent 2 Syringe 810
Replace Reagent 2 Syringe Tip 810
Replace Reagent Syringe 810
Replace Reagent Syringe Tip 810
Replace Sample Syringe 811
Replace Sample Syringe Tip 811
Rinse/Clean Priming Cycle for All Probes 811
Rinse/Clean Priming Cycle for LAS Probe 812
Rinse/Clean Priming Cycle for Reagent 1 Probe 812
Rinse/Clean Priming Cycle for Reagent 2 Probe 812
Rinse/Clean Priming Cycle for Reagent Probe 813
Rinse/Clean Priming Cycle for Sample Probe 813
Routine Clean for All Probes 814
Wipe Down All Probes 814
Wipe Down LAS Probe 814
xvi Instrumentation Laboratory Company

Wipe Down Reagent Probes 815

Wipe Down Sample Probe 815
Performing Maintenance Activities 816
Maintenance Activities (listed alphabetically) 816
Automatic Fluidic Line Priming Cycle 816
Automatic Routine Clean for all Probes 817
Clean Deep Wash and Clean Cup Area – Weekly (Manual Activity) 818
Clean Rack Areas – As Needed (Manual Activity) 819
CTS Foot Cleaning – As Needed (Manual Activity) – CTS Models Only 820
Cuvette Evacuation Cycle – As Needed (Semi-automatic Activity) 821
Empty Cuvette Waste – Daily (Manual Activity) – 300 CTS Models Only 821
Empty Waste Fluid– Weekly (Manual Activity) – 300 CTS Models Only 822
Enhanced Clean for All Probes – Daily for all probes together (Semi-automatic Activity) 823
Enhanced Clean for LAS Probe – As Needed (Semi-automatic Activity) – LAS Models Only 825
Enhanced Clean for Reagent 1 and Reagent 2 Probes – As Needed (Semi-automatic Activity) –
TOP 700 Models Only 826
Enhanced Clean for Reagent 1 Probe – As Needed (Semi-automatic Activity) 827
Enhanced Clean for Reagent 2 Probe – As Needed (Semi-automatic Activity) – TOP 700 Models
Only 828
Enhanced Clean for Reagent Probe – As Needed (Semi-automatic Activity) – 300/500 CTS Models
Only 829
Enhanced Clean for Sample Probe – Daily (Semi-automatic Activity) 830
Foot and Probe Inspection – As Needed (Manual) – CTS Models Only 831
Replace CTS Filter and clean Clean Cup Area – 5000 Piercings (Manual Activity) – CTS Models
Only 832
Replace CTS Piercer – Every 120,000 piercings (Manual Activity) – CTS Models Only 833
Replace LAS Syringe – As Needed (Semi-automatic Activity) 833
Replace LAS Syringe Tip – Every 6 months (Semi-automatic Activity) 833
Replace Reagent 1 and Reagent 2 Syringe Tips – Every 6 months (Semi-automatic Activity) 833
Replace Reagent 1 Syringe – As Needed (Semi-automatic Activity) 833
Replace Reagent 1 Syringe Tip – Every 6 months (Semi-automatic Activity) 833
Replace Reagent 2 Syringe – As Needed (Semi-automatic Activity) 834
Replace Reagent 2 Syringe Tip – Every 6 months (Semi-automatic Activity) 834
Replace Reagent Syringe – As Needed (Semi-automatic Activity) 834
Replace Reagent Syringe Tip – Every 6 months (Semi-automatic Activity) 834
Replace Sample Syringe – As Needed (Semi-automatic Activity) 834
Replace Sample Syringe Tip – Every 6 months (Semi-automatic Activity) 834
Rinse/Clean Priming Cycle for All Probes – As Needed (Semi-automatic Activity) 834
Rinse/Clean Priming Cycle for LAS Probe – As Needed (Semi-automatic Activity) 835
Rinse/Clean Priming Cycle for Reagent 2 Probe – As Needed (Semi-automatic Activity) 836
Rinse/Clean Priming Cycle for Reagent Probe – As Needed (Semi-automatic Activity) 837
Rinse/Clean Priming Cycle for Sample Probe – As Needed (Semi-automatic Activity) 837
Routine Clean for All Probes – As Needed (Semi-automatic Activity) 838
Wipe Down All Probes – As Needed (Manual Activity) – Non-CTS Models Only 839
Wipe Down LAS Probe – Weekly (Manual Activity) 840
Wipe Down Reagent Probes – As Needed (Manual Activity) 841
Wipe Down Sample Probe – Weekly (Manual Activity) – Non-CTS instruments Only 842
Replacing the Syringe and Syringe Tip 843
Instrumentation Laboratory Company xvii

Table of Contents
Hamilton Syringe Procedures 843

CTS Piercer/Probe Replacement Procedure Overview 848
CTS Piercer/Probe Replacement Procedures 848
Probe and Seal Assembly Removal Procedure 849
Probe and Seal Assembly Installation Procedure 853
Piercer Probe Removal Procedure 856
Piercer Probe Installation Procedure 858
Warning Thresholds 860
System Decontamination 862
Cleaning the Monitor 863
Cleaning the Reagent Cooling Filter 864
Diagnostics Overview 865
Cuvettes 866
Viewing the Cuvettes Screen 866
Cuvettes Tab 866
Optical Reading Unit 867
ORU Blanking Procedure 867
ORU Cleaning Procedure 868
ORU Tab 868
ORU Linearity Test 870
Viewing the ORU Linearity Test Screen 870
ORU Linearity Test Tab 870
Controllers, Covers and Racks 871
Viewing the Controllers, Covers and Racks Screen 871
Controllers, Covers and Racks Tab 871
Fluids 872
Viewing the Fluids Screen 872
Fluids Tab 872
Probes/Coordinates Adjustment 873
Accessing the Probes tab 873
Preparing for Adjusting Probe Coordinates 873
Adjusting Probe Coordinates 876
Setting the LAS Aspiration Point Manually 876
Setting the LAS Aspiration Point Semi-Automatically 877
Probes Tab 878
Voltages 880
Viewing the Voltages Screen 880
Voltages Tab 880
Universal Arm 881
Viewing the Universal Arm Screen 881
Universal Arm Tab 881
Fluid Precision Test 882
xviii Instrumentation Laboratory Company

Viewing the Fluid Precision Test screen 882

Fluid Precision Test Tab 882
Instrument Status 883
Viewing Instrument Status 884
Configuring the Alarms Grid and Alarms Chart tabs 884
Filtering the Alarms Grid and Alarms Chart tabs 885
Viewing Status Statistics 885
Instrument Status Operations Toolbar 885
Versions tab 886
Alarms Chart Tab 890
Alarms Display Settings Dialog Box 891
Alarms Filter Dialog Box 894
Status Statistics Screen 896
Instrument Temperatures 898
Viewing Instrument Temperatures 898
Instrument Temperature Window 898
Analytical Versions 899
General Log List 900
Accessing the General Log List 900
Printing a Report 900
Exporting a Report 900
Clearing the Log List 901
General Log List Toolbar Icons 901
General Log Entry Creation window 903
CHAPTER 14 Backup and Restore 905
Backup and Restore 905
Overview 905
Full Backup of Database 906
Full Restore of Database 908
Burn Backup of Database to CD using CIS RecordNow 909
Burn Backup of Database to CD or DVD using Nero Express Essentials 910
Backup and Restore screen 911
CHAPTER 15 Parts and Consumables 913
Parts and Consumables List 913
Most Frequently Ordered Items 913
Less Frequently Ordered Items 914
Reagent Racks, Diluent Racks and Bottle Adapters 915
CHAPTER 16 Reference 919
Reference Section Overview 919
Toolbar Icons 920
Grid Icons 927
Graph Icons 929
Sample Status Color Codes 930
Reagent Status Color Codes 932
Instrumentation Laboratory Company xix

Table of Contents
Reagent Placement 932

Reagent Remaining Stability 932
Reagent On-board Volume 933
LED Status Color Codes 934
Measured Units 935
Measured Units 935
Calculated Units 935
Parallelism Units 935
Calibrated Units 935
Calibration Units 936
Statistical Units 936
Paired Results Units 936
CHAPTER 17 IL Locations 937
Instrumentation LaboratoryWorldwide Locations 937
Glossary 941
Index 945
xx Instrumentation Laboratory Company

CHAPTER 1 About This Manual
CHAPTER 1
ABOUT THIS MANUAL
Welcome to Help
This manual describes the definitions and operational features of your ACL TOP Family instrument. The pri-
mary manual is an online help system that is readily available while using the instrument.
NOTE:
l This manual is for use with all ACL TOP Family models.
l The screens displayed in this manual may vary slightly from what appears on the instrument. This is
due to slight differences on those screens between various ACL TOP models.
General Information
Commonly Used Terms
The following terminology appears throughout this manual:
l Analytical Module – Part of the instrument where sample processing and testing are performed. Also
referred to as the AM and the Analyzer.
l Control Module – A Microsoft Windows™ PC running the ACL TOP software developed by IL.
Also referred to as the CM, it provides the User Interface and Data Management functionality. The
CM connects to the Analytical Module and provides the high level controls. This includes the mon-
itor, keyboard, and mouse.
l System/Instrument – Analytical Module + Control Module
See Terminology and the Glossary for more terms.
NOTE: The terms jobs and tests are used interchangeably both on the instrument and in this help
manual. This is also true for bottles and vials.
User-editable Fields
Many screens contain fields that you can edit, especially those screens having to do with user-defined tests
and materials. Other fields for IL-locked tests and materials, for example, are editable only by IL Test Devel-
opers and these are grayed out. Access to fields varies depending on login level and security setting.
Instrumentation Laboratory Company 1

Chapter 1 – About This Manual
See Also
l Terminology
l General Information Overview
2 Instrumentation Laboratory Company

Important Symbols
Important Symbols
Only trained operators following the procedures described in this manual should use the ACL TOP Family of
instruments. IL declines any responsibility otherwise.
Good laboratory practices dictate that biohazard precautions be taken while operating the ACL TOP and
when handling patient samples, controls, calibrators, or similar materials.
Throughout this manual, you should pay particular attention to paragraphs marked WARNING, CAUTION,
NOTE, and BIOHAZARD. These paragraphs are labeled with the following symbols and contain important
information:
WARNING: Warning statements provide information about electrical hazards
CAUTION: Caution statements provide information about personal injury hazards and product dam-
age hazards.
NOTE: Note statements contain important user information.
BIOHAZARD: Biohazard statements alert you to potentially biohazardous conditions.
See Also
l Hazards
l Symbols

Hazards
WARNING:
On most the ACL TOP instruments, the computer, monitor, keyboard and mouse are located on
the left side of the instrument. On the ACL TOP 700 LAS model, these components are
located on the right side of the instrument to facilitate the LAS Track operation.
Use extreme caution when handling any liquid, liquid waste, cuvette waste, or bulk rinse or
clean fluid on the instrument. Care must be taken to avoid spilling anything that can cause
electrical shorts or other malfunctions related to spills or causing a biohazardous condition
when using the keyboard, mouse, monitor or computer.
Do not connect the analyzer to power before verifying correct voltage setting. The analyzer
can be used with a power (main) voltage of 100-127 VAC or 135-264 VAC (50/60 Hz). Verify
the voltage of the local power (main) to be used. Check the voltage select label located on the
backplate of the analyzer. Listed are the nominal ranges of 115 (for 100-127 VAC input) and
240 (for 135-264 VAC input). Be sure the analyzer is correctly set for the power (main) being
applied. Always plug the analyzer into a grounded outlet.
Allow at least 6 inches (15.24 cm) of clearance on the sides, back, and top of the analyzer to
ensure proper cooling.
This equipment has been tested and found to comply with national and international EMC and
RFI requirements. These requirements are designed to provide reasonable protection against
harmful interference when the equipment is operated in a commercial environment. This equip-
ment generates, uses, and can radiate radio frequency. If not installed and used in accordance
with the manufacturer’s instructions, this equipment may cause harmful interference to radio
communications. Operation of this equipment in a residential area may cause harmful inter-
ference. In this case you will be required to correct the interference at your own expense.
WARNING:
Operating technicians and maintenance personnel are urged to follow sound electrical safety
practices at all times. Although all exposed metal parts of the analyzer are at ground potential
(zero volts), never touch them with one hand while also touching a plumbing fixture, radiator,
AC-operated device, or other grounded object with the other hand.
Before opening the analyzer, remove the power cable from the power outlet. Do not replace
components or attempt any repair with the analyzer switched on. Do not operate the analyzer
in an atmosphere containing explosive gases; components of the analyzer could possibly gen-
erate sparks.
CAUTION:
Avoid spilling fluid on or into the analyzer at any time. Spills should be cleaned up promptly.
WARNING Piercing Hazard:

Hazards
Do not reach hands inside covers while instrument is on. Piercing probe can cause injury if
probe arms are in motion.
BIOHAZARD:
When working with human blood products, all accessible parts of the analyzer must be con-
sidered biohazardous. The analyzer surface, racks, track area, and probes should be routinely
disinfected.
CAUTION Biohazard:
While it is unlikely that spills or leaks will travel to the underside of the instrument or the
table it is on, care should be taken to inspect both the underside of the system and table for
possible leaks. Clean and disinfect any spills discovered. Report leaks to Service personnel for
repair.
See Also
l Important Symbols


CHAPTER 2 General Information
CHAPTER 2
GENERAL INFORMATION
General Information Overview

General information about the ACL TOP Family includes the following:
l Intended Use
l Symbols
l Measured Parameters
l Operating Principles
l Instrument Description
l Monitor and Volume Control
l Manufacturer
l Certification
l System Specifications
l Instrument Specifications
l Test Performance
l Analytical Limitations
l Hazards
l Installing the ACL TOP
l Site Requirements
l Actions Upon Delivery
l Bringing into Operation
l User Training Requirements
l Warranty
l Limitations and Disclaimers

Chapter 2 – General Information
Intended Use
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diag-
nostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
NOTE: Installation and use of any additional software on the ACL TOP control module is not
allowed as it could affect instrument performance. Addition of any software other than validated programs
from the manufacturer would be considered a device modification as defined in the warranty section of this
manual. See Warranty.
See Also
l Warranty

Symbols
Symbols
The following symbols appear on the labels of ACL TOP Family components.
Symbol Description
CE Mark
CSA Mark
Temperature Limitation
Use by
Manufacturer
Batch Code
Biological Risk
Caution: Risk of Danger { IEC 61010.1 }

Consult Accompanying Documents
Caution: Risk of Electric Shock
Note: Important User Information
Attention: Consult Instructions for Use
Catalog Number
Serial Number
In Vitro Diagnostic Device
Authorized Representative
Contains sufficient for <n> tests
Protective Conductor Terminal - Earth

Symbol Description
Earth Ground
Off (supply)
On (supply)
Bar Code Reader Hazard
Stop Action – Instrument stops all moving parts immediately
See Also
l Reference Section Overview
l Important Symbols
l Hazards

Measured Parameters
Measured Parameters
The ACL TOP performs the following types of tests:
l Coagulometric (Turbidimetric) Tests
l Chromogenic (Absorbance) Tests
l Immunological Tests
See Also
l Measurement Units

Operating Principles
Coagulometric (Turbidimetric) Measurements
The principle of coagulometric (turbidimetric) clot detection is used in the system to measure and record the
amount of time required for a plasma specimen to clot. This technique assesses coagulation endpoint by meas-
uring change in optical density.
Clot detection is based on the principle that light passing through a medium in which fibrinogen is con-
verted to fibrin is absorbed by the fibrin strands. Light (671 nm) is transmitted though a sample onto a pho-
todetector, which is positioned 180° to the source.
Light absorption increases as fibrin clot formation progresses. Consequently, light transmittance through the
sample continuously decreases and is measured by the photo detector.
The corresponding electrical signal output from the photo detector changes according to the detected light.
The signal output is processed via software through a series of algorithms to determine the clot point.
Chromogenic (Absorbance) Measurements

Chromogenic tests can be either direct or indirect.
l Direct test – Test where the analyte of interest (e.g. protein C, plasminogen) acts directly on a spec-
ified synthetic substrate.
l Indirect test – Test where the analyte of interest (antithrombin, plasmin inhibitor) reacts with a fixed
quantity of enzyme to form inactive complexes. Under optimized test conditions, residual enzyme
activity is then measured using a specific synthetic substrate.
In most cases, the reaction is monitored at 405 nm by the continuous release of paranitroaniline (pNA) from
the synthetic substrate.
The chromogenic channels use the colorimetric principle of measuring absorbance in the cuvette. An optical
sensor reads light (405 nm) that passes through the cuvette. The light is absorbed by the fluid in the cuvette
in direct proportion to the concentration of pNA. The amount of light reaching the photodetector is con-
verted into an electrical signal that is proportional to the enzyme activity.
Immunological Measurements
The principle of immunological measurement is used on the system to directly measure and record the
amount of an analyte. This technique assesses the physical concentration of the analyte (and not its activity)
by measuring change in optical density.
Although similar to the turbidimetric method, the immunological method relies on the formation of antigen-
antibody complexes to affect light transmission.
Immunological testing of the ACL TOP uses the 405 nm or the 671 nm channels depending on the test and
the reagent formulation.
Both the 405 nm and the 671 nm channels use the principle of measuring absorbance in the cuvette. An opti-
cal sensor reads the light (405 nm or 671 nm) that passes through the cuvette. The light is absorbed by the
fluid in the cuvette in direct proportion to the concentration of antigen-antibody complexes. The amount of
light reaching the photodetector is converted into an electrical signal that is proportional or inversely pro-
portional to the analyte concentration.

Operating Principles
See Also

Instrument Description
Modules
The ACL TOP instrument is composed of two modules:
C ontrol Module (C M)
The CM provides a user interface and operation control. It consists of a personal computer running Win-
dows™ software, keyboard, touch screen display monitor, mouse, and communications interfaces to the AM
and external devices/systems. The CM provides the major functionality associated with the user interface (UI)
including data management, data reduction, LIS (Laboratory Information System) communications, sample
identification, test materials management, fluid management, reporting, test tracking and QC management,
and monitoring.
A nalytical Module (A M)
The AM consists primarily of sample and reagent handling hardware. It processes reagents and auxiliary mate-
rials. It can perform coagulometric (turbidimetric), chromogenic (absorbance), and immunological meas-
urements.
ACL TOP 300 CTS Model
The ACL TOP 300 CTS is a low to medium volume (40 sample capacity) bench-top, fully automatic, ran-
dom-access analyzer that is intended for analysis using both open and closed (capped) sample tubes and hav-
ing cap piercing capability.

ACL TOP 500 CTS Model
The ACL TOP 500 CTS is a mid to large volume (80 sample capacity) bench-top, fully automatic, random-
access analyzer that is intended for analysis using both open and closed (capped) sample tubes and having
cap piercing capability.
ACL TOP 700/ TOP 700 CTS Models
The ACL TOP 700 (includes ACL TOP Base) instrument is a large volume analyzer (120 sample capacity)
intended for open sample tube analysis.
The ACL TOP 700 CTS (includes ACL TOP CTS) instrument is the same as the ACL TOP 700 (includes
ACL TOP Base) but is intended for analysis using both open and closed (capped) sample tubes. Closed tube
analysis is enabled using a cap-piercing capability.
The major parts of the TOP 700 (includes TOP Base) are:
l Control Module (CM) – User interface and operation control
l Analytical Module (AM) – Primarily sample and reagent handling hardware including
o AM Computer

o Cuvette Handling
o Sample Area
o Diluent Area
o Reagent Area
o Bulk Fluids
o Waste Handling
o Sample Handling
o Reagent Handling
o Reaction and Detection
o Interconnect and Power Supply
o Access-restricting Cover with Safety Interlocks
o Instrument-supporting Structure-chassis
o Safety Interlock for Cuvette Waste Drawer
CAUTION: Care must be taken to avoid spilling any liquids and possibly causing electrical shorts or
other malfunctions related to spills.
ACL TOP 700 LAS Model
The system is similar to the instruments described above, having the Control Module (CM) and the Ana-
lytical Module (AM), and also including communications interfaces on the CM with the external devices/sys-
tems of the laboratory automation system.
The ACL TOP 700 LAS Laboratory Automation System (LAS) is a fully automated random access analyzer
designed specifically for in-vitro diagnostic clinical use in the track-automated hemostasis laboratory.
Intended for coagulation and fibrinolysis testing and in the assessment of thrombosis and hemostasis, the
instrument provides results for both direct hemostasis measurements and calculated results.

This instrument interfaces with LAS track in accordance with the CLSI guideline for point-of reference sam-
pling. Primary sample tubes can be introduced to the analyzer via the laboratory automation track or by load-
ing pre-spun open tubes or sample cups directly onto the instrument.
The computer, monitor, keyboard and mouse are located on the right side of the instrument.
NOTE: Capped, unspun samples must be spun and uncapped by the LAS system before moving them
to the analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot
accept capped tubes.
NOTE: Placing items on the cover could cause damage to the cover or LAS arm and probe. Do not
place any items on the LAS arm cover.
Instrument Safety Covers

The LAS area, sample and reagent access covers are designed to provide increased operating safety. The LAS
arm cover is on the far left, the sample area cover is the large cover in the middle, and the reagent area cover
is the large cover on the right. These must remain closed during system operation.
The covers enhance operator safety and reduce the effect of the external environment on the instrument when
operating at environmental extremes and minimize the evaporation from samples and reagents. They help to
maintain temperature control and reduce the effect of stray light on sample data acquisition. The instrument
will not operate with any of the access covers open.
Power Connector
The AM1 power switch is located on the right side of the analytical module, adjacent to the power cord con-
nection. This switch is for the main power supply and controls all power to the AM.
WARNING: This switch must be turned off and the power cord disconnected before performing serv-
ice on the instrument.
NOTE:
l The power supply carries UL/CSA approvals.
l Maximum power requirements for the AM do not exceed 1100 watts.
l The power supplies in both the AM and CM incorporate a power factor correction to prevent har-
monic distortions in the power lines and to satisfy requirements for EMC/EMI Standard EN61326.1.
l The AM incorporates a standard AC input IEC 1010.1-92 connector.
1Part of the instrument where the sample processing and testing are performed. Alternately referred to as the
AM, the Analyzer, and the Analytical Module.

Emergency Stop Button

The emergency stop button is located on the front of the AM. Use this button to immediately stop the instru-
ment, when necessary. Tests that were in progress will need to be restarted.
TOP 300 CTS Emergency Stop Button
TOP 700 Emergency Stop Button
Keypad
The physical keypad on the front of each instrument varies by model. It contains some or all of the following
buttons and indicators:
Status LEDs
These instrument LEDs in some cases correspond to LEDs on the status bar.
l System – Refers to the analyzer status.
l Loader – Status of the cuvette loader.
l Rinse – Status of the rinse solution.
l Clean – Status of the clean solution.

Sample Rack Buttons and LEDs

Press a button to move the bar code reader to the corresponding sample rack position.
The LEDs indicate the status of the sample rack positions.
l Green – Rack position contains a sample rack, and is available to unload. It is NOT an indication
that all samples in that rack have finished testing.
l Amber – Rack position is unavailable, in use and locked.
l No color – Rack position is available to load sample racks, or rack has been rejected.
Diluent Rack Buttons and LEDs

Press a button to move the bar code reader to the corresponding diluent rack position.
The LEDs indicate the status of the diluent rack positions.
l Green – Rack position contains a diluent rack, and is available to unload.
l No color – Rack position is available to load diluent racks, or the rack has been rejected.
Reagent Rack Buttons and LEDs

Press a button to move the bar code reader to the corresponding reagent rack position.
The LEDs indicate the status of the reagent rack positions.
l Green – Rack position contains a reagent rack, and is available to unload.
l No color – Rack position is available to load reagent racks, or the rack has been rejected.
Bar Code Reader Home Button

The Bar Code Reader Home button appears on TOP 300 CTS and TOP 500 CTS models. It bypasses the bar
code reader 30 second timeout before it returns to the home position. The bar code reader must be in the
home position to perform reagent liquid level sensing, or to begin sampling. Pressing this button decreases
the time for sample processing. The Home icon in the toolbar performs this same function.
TOP 300 CTS Keypad
TOP 500 CTS Keypad

Laboratory Automation System (LAS)

The LAS consists of two modules, the LAS manager and an LAS track.
The LAS Manager software determines which samples require testing by the ACL TOP 700 LAS instrument
and routes those samples to it on the LAS track.
The LAS track transports sample tubes to the LAS instrument for processing and consists of the main track
and the sample tube queue.
The instrument has an arm with an unheated probe and syringe, an aspiration area, a holding area, an
enhanced clean area, and a cover with an access door for the placement and removal of the enhanced clean
material, all on the exterior of the left side of the instrument. This module is positioned adjacent to the LAS
track.
Communication between the ACL TOP 700 LAS instrument and the LAS track uses an embedded interface
module (IM). LAS configuration and communication is achieved by means of the LAS Configuration screen.
CAUTION: To avoid contamination, Instrumentation Laboratory strongly recommends against using

the ACL TOP instrument to perform analysis on Hepabsorb samples.
LAS Arm and Probe
When the LAS Manager detects that a sample requires testing, the sample is moved via the LAS track to the
sample tube queue. The LAS arm dispenses the sample material into cuvette cells in the holding area (cuvette
slots 1-3 of the 14 slot holding area). The cuvettes are then moved to slots 6 - 12 in the holding area. From
here the cuvettes are placed in the system, where the sample arm aspirates sample. The sample is processed
the same way as in other ACL TOP instruments. The LAS Manager ensures the sample tube queue does not
become backlogged.

LAS Probe Aspirating from Sample on the LAS Track
NOTE: LAS sample priority is lower than stat1 samples but higher than any front-loaded, normal
priority samples. Stat samples on-board the LAS are treated as LAS priority.
See Laboratory Automation System (LAS) for additional information.
NOTE: Capped, unspun samples must be spun and uncapped by the LAS system before moving them
to the analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot
CAUTION: The computer, monitor, keyboard and mouse are located the right side of the instrument.
Use extreme caution when handling any liquid, liquid waste, cuvette waste, or bulk rinse or clean fluid on
the ACL TOP 700 LAS instrument. Care must be taken to avoid spilling any liquids and possibly causing
electrical shorts or other malfunctions related to spills or causing a biohazardous condition when using the
keyboard, mouse, monitor or computer.
Cuvette Loading Area

The cuvette loading area is on the left side of the AM. A conveyor belt moves the cuvette strips to the
cuvette shuttle, which places them in position to be used by the AM for sample handling.
1In medical terminology, immediate; with no delay. Stat samples have highest priority.

Cuvette Loader
The cuvette loader can be filled with up to 20 clips of 10 cuvette strips each, for a maximum of 200 cuvette
strips (800 cuvette cells).
l A conveyor belt transports the cuvette clips to the front of the loading area.
l Electrical sensors detect when additional cuvette clips need to be loaded onto the system, and inform
the operator by means of an indicator on the front right of the instrument. An amber LED for Cuvette
Loader indicates the loader contains 3 or fewer clips. A red LED indicates the loader is empty.
l The indexer1 pushes the cuvette clip to the right to position it so one strip can be picked up by the
cuvette shuttle.
l As the cuvette strips are used, new cuvette clips are brought forward and positioned for pickup. You
can add more to the loading area while the analyzer is running.
Cuvette Shuttle
The cuvette shuttle picks up a single cuvette strip from the cuvette clip and transports it from one position or
slot to another.
1The part of the cuvette loader which prepares cuvettes for pick-up by the shuttle mechanism.

Cuvette Strip being picked up by Cuvette Shuttle
Bar Code Reader

The bar code reader moves to each track position to allow for insertion of the sample, diluent or reagent
racks. Bar coded information on sample tubes or diluent or reagent bottles is scanned into the instrument as
the racks are inserted.
Move the bar code reader to the desired track using the track buttons on the front of the AM or by clicking
the virtual track buttons displayed on the reagent area screen on the CM. With the bar code reader positioned
in front of the track position, insert the rack. A track guides the insertion of the rack into its correct position.
After the bar code reader has been at a track position for 30 seconds, it moves to its home position. This also
occurs when you select the Run icon in the toolbar.

You can use the Home button on the touch screen when the Sample, Reagent, or Diluent screen is displayed
to immediately move the bar code reader to its home position.
NOTE:
l When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling
a rack out partially while loading or changing bottles, tubes, or sample cups may result in mis-
identification of rack contents.
l Care should be taken when the bar code reader is moving so that your fingers do not get pinched.
l When you use the Home button, the Bar Code Reader warning light (located on the BCR cover)
blinks three times to warn you to clear the path. A rack incompletely placed in a track causes the hom-
ing function to fail, and displays the BCR movement failure error.

Bar Code Reader
This example is the TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS
models.
Sample Area
To the right of the cuvette loader is the sample area where manually placed patient samples are placed on the
AM. The sample tubes or cups are placed on racks that are inserted through a bar code reader.
The sample area is at ambient temperature and can hold 4-12 racks, depending on the model, each capable of
holding 10 samples for a total of 40-120 samples.
When the rack is in use (during aspiration of material) it is locked and an amber LED is displays for the
track position. When the rack is no longer in use the LED changes to green and the rack is released.
The sample rack holds both capped and uncapped sample tubes and open sample cups. Sample racks iden-
tified as CTS are designed to hold capped sample tubes, while those without the CTS designation are for
open sample tubes and cups.
NOTE: When using sample cups they must be IL 2.0 mL sample cups. The use of non-IL sample
cups may lead to improper sampling and incorrect results. See Parts and Consumables List.
The wash station for the sample probe is located behind the sample rack area.
See Also
l Sample Area
l Reagent Area
l Parts and Consumables List

Sample Area with Both LAS Arm (left) and Sample Arm (right)
Sample Rack – non CTS
Sample Rack – CTS

NOTE: For cleaning racks and adapters, IL recommends that you use any of the following:
l 10% bleach
l 0.1 N HCl
l Mild soap
After cleaning, rinse thoroughly with clean water.
DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels.
Sample Arm
The sample arm consists of a probe and syringe used for aspirating and dispensing samples.
Diluent Area
On the ACL TOP Family of instruments, the Diluent Area includes tracks labeled on the front keypad as D1,
D2 or D3, depending on the model.
Diluent tracks to the left side (for example, D1) are accessible by the sample arm (or sample probe on the
TOP 300 CTS).
Diluent tracks to the right side are accessible by the reagent arm (or reagent probe on the TOP 300 CTS).
Each diluent rack can hold up to eight vials of QC materials, calibration and NPP1 plasmas, sample diluents
and clean materials.
See Restriction Map for exact reagent placement by model.
See Diluent Area.
1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International
Normalized Ratio (INR) and when calculating test results that use the normalized ratio.

Diluent Area with Sample Probe
Diluent Rack
l 10% bleach
l 0.1 N HCl
l Mild soap

Reagent Area
The Reagent Area is on the right side of the AM1. There are 3-6 tracks each with six reagent positions, that
hold 18-36 reagents. As with sample racks, reagent racks are inserted into reagent tracks by means of the bar
code reader.
This area is cooled to 15° C ± 3° C. Positions 1 and 2 on each rack allow for the use of magnetic stir bars.
See Restriction Map for exact reagent placement by model.
Reagent Area Showing Intermediate (left) and Start (right) Reagent Arms
Reagent Arms
There are up to two reagent arms, depending on the model. The left reagent arm when present, is used for
aspirating/dispensing materials placed in D3, and intermediate and start reagents in reagent racks placed in
R1-R4. (An intermediate reagent is one that, when mixed with sample, activates certain constituents of the
sample but is not enough to bring the reaction to completion.)
On models with multiple reagent arms, the right reagent arm is used for aspirating/dispensing start reagents
from tracks R3-R6 of the Reagent Area. (A start reagent is one that, when mixed with the sample or sample
mixture, begins the reaction of interest. It must be the final reagent added to the cuvette cell.)
On TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS models, both rea-
gent arms can access positions in tracks R3-R4 in the Reagent Area.
On TOP 300/500 CTS models, the reagent arm may access all reagent racks.
See Restriction Map for exact configurations.
CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid dam-
aging the probe arm during the move, grasp it from the back, as near to the back wall as possible. Grasp-

ing a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate coor-
dinates adjustment and other errors.
The wash station for the left reagent probe is located in the back left side of the reagent area; the wash sta-
tion for the right reagent arm is located in the back right side of the reagent area.
See Also
l Reagent Area
Reagent Rack
l 10% bleach
l 0.1 N HCl
l Mild soap
Probe
The probes are the vertical part of the LAS, sample or reagent arms that are in contact with the liquid.
Each probe has a sensor that recognizes the presence of liquids and stops at the optimized liquid level. A Tef-
lon tube connects the sample or reagent probe to a syringe that is capable of delivering 4 to 250 µL. The
LAS probe has a maximum volume of 1000 µL.
The reagent probes are heated and heat liquids being pipetted to 37° C ± 1° C.
If a probe appears to be damaged, bent, shows visible corrosion, or if you are experiencing frequent liquid
level detection failures, the probe may need to be replaced. Contact Service.
Whenever a probe is replaced, the arm coordinates must be adjusted.

Probe (in foreground) and Syringe
Probe Syringes
There is a syringe pump for each probe to enable the separate movement of rinse, clean, sample or reagent
through the probe.
Incubators
Behind the rack areas are two incubators that are used for the sample and/or reagent incubation phase(s) of
the test.
The sample incubator can hold up to 8 cuvette strips (4 for TOP 300 CTS). The reagent incubator can hold
up to 8 cuvette strips (4 for TOP 300 CTS). The incubator temperature is maintained at 37.0° C ± 0.5° C.
In the sample incubator, sample material is pipetted into the cuvette cells. The cuvette strips are then moved
into the reagent incubator where intermediate reagents are dispensed.
Right Sample Probe and Incubator Slots

Optical Reading Unit

There are 2-4 optical reading units (ORUs), each with four reading stations, located to the right of the reagent
incubator where start reagents are dispensed into the cuvette cells to start a reaction. Readings are taken of
the reaction using wavelengths of 671 nm for coagulometric, 405 nm for chromogenic, and either 671 or 405
nm for immunologic measurements.
Instrument Model # ORUs # Reading Channels
TOP 300 CTS 2 8
TOP 500 CTS 3 12
TOP 700 (includes TOP Base) 4 16
TOP 700 CTS (includes TOP CTS) 4 16
TOP 700 LAS 4 16
System Fluids – Rinse and Clean

The rinse fluid system and the clean fluid system remove contaminants from the system to reduce the risk of
carryover1 affecting test results.
These fluids clean not only the internal surfaces of the probe and the related tubing, but also the external sur-
face of each probe tip, removing contaminants that may have contacted the probe during fluid aspiration.
Rinse Fluid System

The rinse fluid is used to rinse the probes after the aspiration and dispensation of a test fluid. Typically, the
probe is rinsed after each syringe pump cycle. However, in instances where a common reagent is being dis-
pensed into consecutive cells, the rinse pump may not be operated until after the final dispense. The amount
of rinse fluid used is not test-dependent.
The rinse fluid system is composed of the system rinse fluid bottle, the rinse fluid tubing, two rinse pumps,
the rinse pump tubing, the rinse/clean stations in the sample and reagent areas, and the waste fluid.
Each probe is connected to a dedicated rinse pump and has a dedicated rinse/clean station at which it is posi-
tioned during the operation of the rinse cycle. The probe is positioned above the rinse cup and rinse is dis-
pensed through the probe into the rinse cup. Rinse dispensed from the probe enters the rinse cup, displacing
any rinse that is in the rinse cup. Any excess fluid that overflows from the rinse cup drains into the accumu-
lator through an opening in the bottom of the rinse/clean station.
The rinse fluid is placed on the ACL TOP instrument in a 4L rinse bottle. A rinse fluid sensor located on the
front of the AM2 monitors the level of rinse fluid. It displays an amber warning light (except for TOP 300
CTS) when the level drops below 1000 mL, and displays a red error light when the level drops below 600
1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to
another sample when the probe enters it.

mL. If the rinse fluid sensor changes to red during the BUSY state, the instrument performs a controlled stop
to finish running the active tests. The remaining tests do not run until the operator replaces the rinse, and
presses Start again. If the rinse fluid drops below 100 mL the system performs an emergency stop.
CAUTION: Do not replace the rinse fluid when the instrument is Busy or in a Controlled Stop.
l When replacing the rinse fluid ensure that the computer, monitor and keyboard are moved far enough
out of the way to prevent any rinse spilling on them.
l The 4 liter rinse bottle is not designed to be refilled during instrument operation. We recommend peri-
odic changing of the rinse bottles to prevent accumulation of particulates and other contaminants.
l Do not top off. Refilling (topping off) the 4 liter rinse bottle during operation of the instrument may
cause the introduction of air bubbles into the tubing. This can happen if the bottle is almost empty or
if the end of the tubing is raised above the liquid level. Bubbles created in the rinse fluid can enter
the rinse tubing and cause improper rinsing of the probes. Extra care should be taken to ensure that
any manipulation of the contents of the rinse bottle doesn't create bubbles.
Clean Fluid system

The clean fluid system is composed of the system clean fluid bottle, the clean fluid tubing, a pump, a man-
ifold, three valves, clean cup tubing, the rinse/clean stations and fluid waste. A pump is used to transport
clean fluid from the clean fluid bottle to the clean stations. Each rinse/clean station contains a clean cup that
serves as a reservoir for the clean fluid. The clean cups are filled from the bottom.
The probe enters the clean fluid and aspirates fluid from the clean cup, the pump is operated and the valve
dedicated to the clean cup is opened. Clean fluid is pumped into the clean cup. The volume of clean fluid
pumped into the clean cup is sufficient to not only fill the clean cup, but to also flush any contaminants from
the clean cup. Any excess fluid that overflows from the clean cup drains into the accumulator through an
opening in the bottom of the rinse/clean station.
A cleaning cycle is used to clean the probe at specific times during the operation of the instrument. It cleans
the probe more completely than the rinse system. The probe aspirates clean fluid from the clean cup in the
rinse/clean station or from a bottle of clean material place on a rack and dispenses the clean fluid into the
rinse/clean station.
A clean fluid sensor located on the front of the AM (except for TOP 300 CTS) monitors the level of clean
fluid and displays an amber warning light when the level drops to 75 mL. It displays a red error light when
the level drops to 25 mL. If the clean fluid sensor changes to red while the instrument is Busy, the instrument
performs a controlled stop after running the active tests. Wait until the system comes to a complete stop,
replace the bottle with a new one, then restart the testing.
For the LAS probe only:
If the instrument detects an insufficient volume of clean material during testing, an emergency stop is per-
formed to prevent possible contamination.
CAUTION: Do not replace the clean fluid during busy or controlled stop. When replacing the clean
fluid ensure that the computer, monitor and keyboard are moved far enough out of the way to prevent any
clean fluid spilling on them.
See Rinse Fluid and Clean Fluid.

Rinse (left) and Clean Bottles with Fluid Waste Container Underneath

Fluid Waste
A fluid waste pump (except for TOP 300 CTS) removes fluid from the internal waste reservoirs located under
the Clean and Rinse stations in the Sample and Reagent Areas. Sensors in each reservoir detect when the
accumulator is full, and turn on the pump for a configured span of time to empty the waste into the waste
container.
NOTE: The TOP 300 CTS uses gravity to empty waste fluid from the reservoirs. A sensor indicates
when fluids fail to empty. If fluids back up, the system performs an emergency stop.
Waste Container
A 10 liter waste container holds the fluid waste pumped from the accumulators. A waste fluid sensor (except
for TOP 300 CTS) on the front of the AM1 warns the operator when the waste container is nearly full by
turning amber (warning), and turning red (error) when the waste container is full. When the sensor turns red,
the instrument performs a controlled stop. If the waste container is not replaced with an empty one, the instru-
ment eventually performs an emergency stop. You must empty or change the waste container before running
more tests.
See Empty Waste Fluid.
CAUTION Biohazard:
l Fluid Waste is biohazardous. Use precautions when changing or emptying the fluid waste bottle.
Refer to local and state regulations for disposal of potentially hazardous materials.
l The TOP 300 CTS model does not have a waste fluid sensor. You must empty the waste container
frequently. See Fluid Waste.
See Also
l Fluid Waste
l Controlled Stop
l Emergency Stop
Cuvette Waste Container

The cuvette waste container is located on the lower right side of the instrument behind the cuvette waste
door (the TOP 300 CTS does not have a door).
The cuvette waste module includes an accumulator that allows the cuvette waste drawer to empty without
shutting down the instrument (the TOP 300 CTS does not have a cuvette waste accumulator). Six used
cuvette strips are moved onto the accumulator as readings are finished, then deposited into the cuvette waste
drawer. The cuvette waste liner has a capacity of 100-250 (+/- 10) used cuvettes, depending on the model.

Cuvette waste liners are used in the cuvette waste drawer to contain used cuvette strips, keep the waste
drawer clean and free of contaminants, and facilitate disposal of the waste cuvettes.
CAUTION Biohazard:
l Cuvettes waste is biohazardous. Use precautions when emptying the cuvette waste drawer. Refer to
local and state regulations for disposal of potentially hazardous materials.
l The TOP 300 CTS model does not have a cuvette waste sensor. You must empty the cuvette waste
liner frequently. See Empty Cuvette Waste.
Cuvette Waste Door Open
Cuvette Waste Container – TOP 300 CTS
When the waste drawer is removed, the analyzer performs a controlled stop, and completes only the tests that
are running, providing the cuvette accumulator is not full. If the drawer is re-inserted before the running tests
are finished, the AM1 cancels the controlled stop and finishes running the tests on all the samples. If the

active tests are completed before the drawer is reinserted, the AM enters the READY state. You must restart
the remaining tests. If the cuvette waste drawer is not reinserted, the instrument does not restart.
The following two status indicators appear on the front of the AM for the cuvette waste:
l Door open indicator – Turns green when the waste door is open.
l Cuvette waste indicator – Turns amber (warning) when the drawer is nearly full. Turns red (error)
when the waste drawer is full or removed.
Cuvette Waste Drawer
See Also
l Operating Principles
l Intended Use
l LED Status Color Codes

Monitor and Volume Control
NOTE: Instrumentation Laboratory recommends the monitor volume be turned up to maximum vol-
ume. Consult the monitor manufacturer's user guide.
Calibrating the All-in-One CM Monitor Touch Screen

To calibrate the All-in-One monitor touch screen supplied with the ACL TOP 300 CTS model.
1. Select the Microsoft Windows Start button.
2. Select Programs > PenMount Universal Driver > PenMount Control Panel.
3. Select the PenMount icon, and select Configure.
4. Select Standard Calibration.
5. Follow the screen prompts to complete touch screen calibration.

All In One Monitor Diagrams

The diagrams in this section apply to the All In One Monitor and CM1 supplied with the ACL TOP 300 CTS
model.
Function/Control
NOTE: Auto Adjust aligns the screen when it becomes misaligned.
1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User
Interface and data management functionality. The CM connects to the Analytical Module and provides the
high level controls.

Connectors

Configuring Volume Control on the ELO Touchsystems Entuitive Mon-

itor
The ELO Touchsystems Entuitive monitor is configured with speakers. The volume of these speakers can be
changed to accommodate laboratories with varying ambient noise. The Touchmonitor factory sound is con-
figured to be very low. Use the following procedure to increase the sound of the speakers:
1. On the right side of the monitor are five push buttons. They are, from top to bottom, MENU, UP
arrow, DOWN arrow, SELECT and POWER.
2. Select the menu button to display a menu window on the Touchmonitor. Using the up or down arrow
buttons, navigate to the volume setting (symbol). Press the select button to choose the volume setting.
3. Using the up or down arrow buttons, configure the volume of the speakers. Press the select button to
store the volume setting.
4. Select the menu button to exit the menu functionality.
See Also

Manufacturer
Manufacturer
The ACL TOP Family of instruments is manufactured by:
Headquarters
Instrumentation Laboratory Company
180 Hartwell Road
Bedford, MA 01730-2443 U.S.A.
Telephone: 1-781-861-0710
Fax: 1-781-861-1908
http://www.ilus.com
See Also
l Worldwide Locations

Certification
CE Certification
The CE label on the back of the instrument indicates that the ACL TOP instrument conforms to the European
Directives as stated in IL’s Declaration of Conformity.
EU Directive:
l IVD - 98/79/EC (27/10/1998) – Annex I and III
Applicable standards:
l CEI/IEC 61326-1: 1998 (Class A)
l CEI/IEC 61010-2-04
CSA Certification
The CSA label on the back of the instrument indicates that the Canadian Standards Association (CSA) has
certified the ACL TOP instrument to the applicable standards.
Applicable standards:
l CAN/CSA C22.2 No. 1010.1-92
l UL Std. No. 61010-1, 2nd Edition
LOPD (Data Protection Organic Law)

Directive 95/46/CE of the European Parliament and the Council Directive of October 24th, 1995.
European regulation on data protection, concerning:

Austria Germany Netherlands
Belgium Greece Portugal
Denmark Ireland Spain
Finland Italy Sweden
France Luxembourg United Kingdom
l European Parliament and Council Directives and Regulations on Data Protection
l Spanish Constitution of 1978
l Organic Law 15 of December 13th, 1999, on Personal Data Protection (LOPD)
l Royal Decree 994/1999 on Security Measures. Royal Decree 1332/1994

Certification
l Regulation of the Computerized Processing of Personal Data

l Spanish Data Protection Agency instructions
Other Certification
The ACL TOP instrument meets CEI/IEC 61010-1, 2001 Mod, Second Edition, for the following:
l External surface temperature
l Flame resistance
l Fluid resistance
l Internal air flow and temperature
l Audible noise
l Product labeling
The ACL TOP instrument shipping crate complies with the International Safe Transit Packaging Testing Pro-
cedure 1B (June, 1999), ASTM 999.
European Union Directive 2002/96/EC on Waste Electrical and Electrical Equip-

ment (WEEE)
Instrumentation Laboratory is committed to meeting or exceeding the conditions of the WEEE Directive and
being a good environmental partner. In compliance with the WEEE Directive, beginning with product
shipped after August 13, 2005, all instruments are labeled with the symbol shown above.
Disposing of this product correctly helps prevent potential negative consequences for the environment and
for human health. Recycling conserves natural resources.
Penalties may be applicable for incorrect disposal of this waste, in accordance with national (European) leg-
islation.
Please call your local Instrumentation Laboratory distributor for information regarding the disposal of any
end-of-life instruments.

System Specifications
l ACL TOP 300 CTS Specifications
l ACL TOP 500 CTS Specifications
l ACL TOP 700 and 700 CTS Specifications
l ACL TOP 700 LAS Specifications
See Also
l Test Performance
l Hazards

ACL TOP 300 CTS Specifications

The TOP 300 CTS is a bench top, fully automated, random access coagulation instrument characterized by its
ability to analyze a medium volume of samples with excellent throughput and a extended walkaway time.
The TOP 300 CTS model meets the needs of medium size routine and specialty laboratories. Most important
for users are features that provide consistency of test results across ACL TOP family members, minimize the
need for user interaction, and increase the efficiency and safety of laboratory procedures.
TOP 300 CTS Specifications

Test Menu Clotting tests YES (standard)
(671 nm)
Chromogenic tests YES (standard)
(405 nm)
Immunological YES (standard)
tests (671 or 405
nm)
System Con- ACL TOP 300 Compact design with coagulometric, chromogenic and immunologic
figurations CTS tests; and open tube sampling and closed tube sampling with cap pierc-
ing.
Throughput PT tests/hour Up to 110
APTT tests/hour Up to 110
PT & APTT Up to 110
tests/hour
Random access YES
Continuous sample loading YES
Continuous reagent loading YES
Continuous cuvettes loading YES
Sample transport system Racks
Samples on-board 40 (10 samples/rack)
Sample containers Primary tubes and cups
Sample bar code reader YES (integrated)
Sample pipetting arms/probes Configurable CTS
Sample liquid level sensing YES (capacitance probe)
Sample area protection cover YES (with lock and sensor)
Reagent transport system Racks
Reagents on-board (refrigerated) 26 (18 positions in reagent racks + 8 positions in diluent racks)
Reagent containers Original bottles
Reagent bar code reader YES (integrated)
Bar coded reagents YES (bar code includes lot, exp. date and bottle size)
Hand-held 2D bar code reader YES
Reagent pipetting arms/probes 1 reagent probe is integrated on common arm
Reagent liquid level sensing YES (capacitance probes)

TOP 300 CTS Specifications

Reagent area protection cover YES (with lock and sensor)
Cuvettes on-board 800
Cuvettes type Plastic disposable (4 cuvettes/strip)
Applications on-board 500
User programmable applications 250
Tests per sample 30
Walkaway capability 400 tests. (100 cuvette strip capacity of cuvette waste container)
Sample pre dilution YES
Calibration curve pre dilution YES
Factor parallelism YES
STAT capability YES (at any time in any position)
STAT time Time to PT result when the system is idle: ~ 3 minutes
Rerun testing YES (configurable)
Reflex testing YES (configurable)
Reaction curves display YES
Quality Control program YES (with configurable multi-rules)
Results auto validation YES
Patient samples results database 2,000 - 20,000 samples (configurable)
QC results database 2,000 - 20,000 samples (configurable)
Security system YES (configurable)
Events log system YES
Bi-directional interface YES
Host Query function YES
PC External (Intel Processor)
Operating System Windows XP
Touch Screen Monitor (integrated 17 inch color LCD (external)
with CM computer)
Keyboard YES (external)
Mouse YES (external)
User Interface Windows based
Dimensions Width 81 cm (32 inches)
(analyzer)
Depth 84 cm (33 inches)
Height 73 cm (29 inches)
Weight 91 kg (200 pounds)
See Also
l Test Performance


The TOP 500 CTS is a bench top, fully automated, random access coagulation instrument characterized by its
ability to analyze a medium-to-large volume of samples with high throughput and a long walkaway time.
The ACL TOP 500 CTS meets the needs of medium to large size routine and specialty laboratories. Most
important for users are features that provide consistency of test results across ACL TOP family members, mini-
mize the need for user interaction, and increase the efficiency and safety of laboratory procedures.

Test Menu Clotting tests (671 YES (standard)
nm)
(405 nm)
tests (671 or 405
nm)
System Con- ACL TOP 500 Compact design with coagulometric, chromogenic and immunologic
figurations CTS tests; and open tube sampling and closed tube sampling with cap pierc-
ing.
Throughput PT tests/hour Up to 240
PT & APTT Up to 180
tests/hour
Random access YES
Sample pipetting arms/probes Configurable CTS
Reagents on-board 40 (24 positions in reagent racks + 16 positions in diluent racks)
Reagents on-board storage tem- 40 refrigerated (24 refrigerated positions in 4 reagent racks, 16 refrig-
perature erated positions in 2 diluent racks)
Hand-held 2D bar code reader YES


Reagent pipetting arms/probes 1
Tests per sample 30
Walkaway capability 2400 tests (max. 80 samples on-board X max. 30 tests per sample)
PC External (Intel Processor)
Operating System Windows XP
Monitor 17 inch color LCD (external)
Touch screen YES
(analyzer)
Weight 142 kg (312 pounds)

ACL TOP 700 and 700 CTS Specifications

This topic describes specifications for the ACL TOP 700 (includes ACL TOP Base) and ACL TOP 700
CTS (includes ACL TOP CTS) instruments:
These instruments are bench top, fully automated, random access coagulation instruments characterized by
their ability to analyze a high volume of samples with high throughput and a long walkaway time.
These instruments meet the needs of the large routine and specialty laboratories. Most important for users are
features that provide consistency of test results across ACL TOP family members, minimize the need for user
interaction, and increase the efficiency and safety of laboratory procedures.

Test Menu Clotting tests (671 YES (standard)
nm)
(405 nm)
tests (671 or 405
nm)
System Configurations Base Coagulometric, chromogenic and immunologic tests; open tube
sampling
CTS Base configuration + Closed Tube Sampling (cap piercing)
Throughput (base PT tests/hour Up to 360
model)
PT&APTT Up to 330 (165 samples of each test/hour)
tests/hour
Throughput (CTS PT tests/hour Up to 270
model)
PT & APTT Up to 260 (130 samples of each test/hour)
tests/hour
Random access YES
Hand held 2D sample bar code reader YES
Sample pipetting arms/probes 1 (standard) + 1 (optional cap-piercing)


Reagents on-board 60 (36 positions in reagent racks + 24 positions in diluent
racks)
Reagents on-board storage temperature 44 refrigerated + 16 room temperature (36 refrigerated positions
in 6 reagent racks, 8 refrigerated positions in 1 diluent rack, 16
room temperature positions in 2 diluent racks)
Tests per sample 30
Walkaway capability 120 samples
Analytical Reference YES
Operating System Windows XP Service Pack 2
Touch screen YES


Dimensions (analyzer) Width 151 cm (59 inches)
Weight (Base TOP analyzer) 162 kg (356 pounds)
Weight (CTS TOP analyzer) 166 kg (367 pounds)

ACL TOP 700 LAS Specifications

The ACL TOP model is a fully automated random access analyzer designed specifically for in-vitro diag-
nostic clinical use in the track-automated hemostasis laboratory. Intended for coagulation and fibrinolysis test-
ing and in the assessment of thrombosis and hemostasis, the LAS provides results for both direct hemostasis
measurements and calculated results.
The TOP 700 LAS model is designed to interface with laboratory automation track systems in accordance
with the CLSI guideline for point-of-reference sampling. Primary sample tubes can be introduced to the
analyzer via the laboratory automation track or by loading pre-spun open tubes or sample cups directly onto
the instrument. The LAS instrument is mounted to a table.
The TOP 700 LAS model meets the needs of large routine and specialty laboratories. Most important for
users are features that provide consistency of test results across ACL TOP family members, minimize the need
for user interaction, and increase the efficiency and safety of laboratory procedures.

Test Menu Clotting tests YES (standard)
(671 nm)
Chromogenic YES (standard)
tests (405 nm)
tests (671 or
405 nm)
System Con- LAS Coagulometric, chromogenic and immunologic tests; open tube sam-
figurations pling + Laboratory Automation System compatibility
Random access YES
Hand held 2D sample bar code YES
reader
Sample pipetting arms/probes 1 (standard) + 1 (off-board)
(for volume tracking)
LAS area protection cover YES (with sensor)
Reagents on-board 60 (36 positions in reagent racks + 24 positions in diluent racks)


Reagents on-board storage tem- 44 refrigerated + 16 room temperature (36 refrigerated positions in 6
perature reagent racks, 8 refrigerated positions in 1 diluent rack, 16 room tem-
perature positions in 2 diluent racks)
User programmable appli- 250
cations
Tests per sample 30
Stat capability YES (for manually loaded samples at the front of the instrument, at any
time in any position)
Stat time Time to PT result when the system is idle: ~ 3 minutes
Patient samples results data- 2,000 - 20,000 samples (configurable)
base
Host query function YES
PC External (Pentium IV)
Operating system Windows XP
Touch screen YES


(analyzer)
Weight (total) 319 kg (703 pounds)
Analyzer 184 kg (406 pounds)
Table 135 kg (297 pounds)

Test Performance
Test Performance
The data presented here is representative of the ACL TOP Family.
Typical Precision Performance

The following are typical performance characteristics provided only as examples. Refer to product insert
sheets to obtain specific information.
Typical Precision
Typical precision was performed using normal and abnormal controls. Precision is calculated following CLSI
Document EP5-A.
Within run and total precision assessed over multiple runs (n=80) using multiple levels of control plasma
gave the following results:
Reagent Type Control Level Mean Within Run Total

(Result Unit) %CV %CV
Antithrombin Normal 108.5 5.7 5.8
(%) Low Abnormal 53.5 5.6 6.8
High Abnormal 32.0 6.8 9.1
APTT Normal 30.3 1.2 1.6
(seconds) Low Abnormal 49.3 0.9 2.1
D-Dimer Low Control 340 4.6 7.7
(ng/mL) High Control 729 2.5 4.5
Factor II Normal 110.7 4.2 5.2
(%) Low Abnormal 64.5 4.1 5.3
Factor V Normal 124.7 4.0 4.7
(%) Low Abnormal 79.9 3.0 4.7
Factor VII Normal 106.2 3.6 3.9
(%) Low Abnormal 61.3 2.1 3.7
Factor X Normal 114.6 1.8 2.8
(%) Low Abnormal 64.6 2.2 3.4
Fibrinogen-C (mg/dL) Normal 364.7 7.9 8.8
Low Fibrinogen 92.9 7.7 8.4
Protein C Normal 120.4 2.6 3.3
(%) Low Abnormal 30.9 3.0 4.3
Prothrombin (PT) Normal 11.9 1.3 1.4

Reagent Type Control Level Mean Within Run Total

(Result Unit) %CV %CV
(seconds) Low Abnormal 25.7 1.5 2.7
PT-Based Fibrinogen Normal 302.6 3.7 4.1
(mg/dL) Low Fibrinogen 128.2 7.7 7.8
Typical Method Comparison

Typical method comparison was performed using normal and abnormal patient samples. Method comparison
is calculated following CLSI Document EP9-T.
In method comparison studies evaluating citrated plasma samples, the ACL TOP Familymember and the ACL
Advance (predicate device) were shown to be statistically similar as shown below.
Reagent Type n Slope Intercept r Sample Range

(Result Unit)
Antithrombin 123 1.03 -1.418 0.9660 25.0 to 121.7
(%)
APTT 205 1.076 -0.380 0.9943 24.2 to 236.7
(seconds)
D-Dimer 120 1.12 -16.0 0.993 84 to 19809
(ng/mL)
Factor II 101 0.95 -0.551 0.9753 6.0 to 128.2
(%)
Factor V 93 0.81 4.742 0.9822 2.1 to 149.3
(%)
Factor VII 96 0.882 3.153 0.9922 6.3 to 147.4
(%)
Factor X 109 0.97 2.995 0.9954 5.0 to 142.3
(%)
Fibrinogen-C 98 1.00 -8.740 0.9759 121.6 to 695.0
(mg/dL)
Protein C 123 1.15 -0.323 0.9902 9.4 to 129.7
(%)
Prothrombin (PT) 150 0.990 1.46 0.9987 9.8 to 107.4
(seconds)
PT-Based Fibrinogen 93 1.084 -9.93 0.9587 121.6 to 695.0
(mg/dL)

Test Performance
A ntithrombin
A PTT
D -D imer

Factor II
Factor V
Factor VII

Test Performance
Factor X
Fibrinogen-C (C lauss Method)
Protein C (%)

Prothrombin Time (PT)
PT-B ased Fibrinogen

Test Performance
Typical Linearity
Linearity studies were performed using multiple sample levels with each level tested in replicates of four on
an ACL TOP Family member. Results are shown in the table below.
Reagent Type
(Result Unit) No. of Levels Test Range Slope r2
Antithrombin 9 Levels 0 to 152.7 0.9039 0.9991
(%)
D-Dimer 9 Levels 143.7 to 1086.7 1.0000 0.9984
(ng/mL)
Factor II 9 Levels 0.86 to 154.13 0.9946 0.9997
(%)
Factor V 9 Levels 1.04 to 187.34 0.9540 0.9986
(%)
Factor VII 9 Levels 0.92 to 165.33 0.9411 0.9981
(%)
Factor X 8 Levels 0.95 to 143.03 0.9322 0.9975
(%)
Fibrinogen-C 9 Levels 72.2 to 721.6 0.9164 0.9866
(mg/dL)
Protein C 7 Levels 5.6 to 166.8 0.9237 0.9948
(%)
Prothrombin Time (PT) 9 Levels 12.3 to 160.3 1.0222 0.9992
(%)
PT-based Fibrinogen 10 Levels 58.3 to 777.8 0.9015 0.9978
(mg/dL)
Interference
Refer to the product insert sheets.
See Also

Analytical Limitations
On the ACL TOP instrument sample carryover1 is negligible. In most situations inaccuracy attributed to car-
ryover is within the normal imprecision of the method, and therefore not statistically or clinically significant.
NOTE: Refer to the reagent label for test-specific interference and limitation information.
See Also
l Test Performance

Installing the ACL TOP Instrument
Installing the ACL TOP Instrument

Review the following regarding the installation of your system:
l Site Requirements
l Bringing Into Operation

Site Requirements
IL personnel or other person(s) duly authorized by IL must install the ACL TOP instrument.
NOTE:
l The control module (CM) is dedicated to a specific ACL TOP instrument. Any attempt to swap the
CM with one from another ACL TOP Family instrument results in the following warning: CM is in
use from a different ACL TOP model. Use of this CM will require Service intervention.
l The CM for the ACL TOP instrument is a dedicated computer. Do not install any other software appli-
cation on it as this would qualify as a modification. Modifications to the programming or the instru-
ment may affect instrument performance and may void IL's warranty. Do not use thumb drives (USB
flash drives) that contain third-party software on the instrument. Do not plug or unplug any cables or
drives without Service guidance.
l The ACL TOP instrument complies with all local, state and national regulations and requirements in
the US for installation and site requirements.
CAUTION: The ACL TOP instrument weighs from 200-365 pounds (91-166 kg) depending on the
model. Use extreme care when moving the instrument. A total of four people should be used. Two people
should lift using the two molded handles in the rear of the unit. The third and fourth persons should each
take a front corner.
Limited Warranty
Instrumentation Laboratory is responsible for the safety and electrical performance of this equipment under
the following mandatory conditions:
l Persons authorized by IL carry out assembly operations, extensions, adjustments, modifications or
repairs.
l The electrical installation of the room complies with the local, state, or national requirements (includ-
ing power supply circuit with independent grounding).
l The equipment is used in accordance with these instructions.
l IL brand products are used. Non-IL brands are not covered.

Site Requirements
Spatial Requirements
Maximum Dimensions for Analytical Module (AM)
All measurements are in centimeters/inches and kilograms/pounds.
Model Weight Height Depth Width
TOP 300 91 kg 73 cm 84 cm 81 cm
CTS 200 lbs 29 in 33 in 32 in
TOP 500 141 kg 73 cm 81 cm 110 cm

TOP 700 162 kg 73 cm 76 cm 151 cm

356 lbs 29 in 30 in 59 in
TOP 700 166 kg 73 cm 76 cm 151 cm

TOP 184 kg 73 cm 76 cm 188 cm

700 LAS 406 lbs 29 in 30 in 74 in
With integrated
table
319 kg
703 lbs
NOTE: In the LAS configuration the instrument is bolted to the table.

The instrument must be positioned so that a waste tube can be connected to the right side of the unit without
any kinks or bends that could cause an obstruction.
The instrument must be positioned so that there is at least 15.2 cm (6 inches) clearance on all sides, back and
top for proper air circulation.
Maximum Dimensions for Stand-alone Control Module (CM)

For all models except TOP 300 CTS.
Weight Height Depth Width
17 kg 45 cm 49 cm 19 cm

37 lbs 17.5 in 19 in 7.5 in
Maximum Dimensions for the Touch Screen Monitor

Excludes TOP 300 CTS.
Height Depth Width
37 cm 8 cm 43 cm

Height Depth Width
14.5 in 3 in 17 in
Maximum Dimensions for Integrated CM and Touch Screen Monitor

For TOP 300 CTS model.
Height Depth Width
36 cm 9 cm 43 cm
14 in 3.5 in 17 in

Site Requirements
Electrical Requirements
The instrument is designed to operate correctly with electrical variations to ±10% in an ambient temperature
of 15° C to 32° C (59° F to 89° F) with a relative humidity of 5%-85% (non-condensing). The instrument
should be placed in an area free from dust, fumes, vibrations and excessive variations of temperature. The
instrument should not be used at an altitude greater than 2000 meters.
The ACL TOP instrument is single phase, has current leakage of less than 500 µAmps, and produces 2,049
BTUs per hour.
In accordance with safety standard IEC 1010, paragraph 1.4, there is no safety hazard in the temperature
range 5-40° C.
The instrument is designed to operate correctly with electrical variations of up to ±10% on the nominal
supply and with supply frequencies between 47 and 63 Hz.
WARNING: Ensure the supply voltage in the laboratory is compatible with the label on the rear of
the AM1 as shown in the following table:
Value of supply voltage Current Value as shown

for normal function (A) on the label
240V AC ±10% 5A 100-240 VAC
115V AC ±10% 10 A 100-240 VAC
100V AC ±10% 10 A 100-240 VAC
The CM2 requires an input voltage between 100-240V and an amperage of 3.5A.
The monitor requires an input voltage between 100-240V and an amperage of 1.8-0.9A.
The power cord provided with the instrument is a certified cord with a three-prong, double insulated,
grounded (NEMA) receptacle and plug.

Instrument Volt-Amps Specifications

ACL TOP Analytical Module
Volts AC Amps Volts/Amp Watts Frequency
100 VAC 10A 1000 VA 600 W 50/60Hz
115VAC 10A 1150 VA 600 W 50/60Hz
240VAC 5A 1200 VA 300 W 50/60 Hz
ACL TOP Control Module

100 VAC 6A 600 VA 600 W 50/60Hz
115VAC 6A 690 VA 600 W 50/60Hz
240VAC 3A 720 VA 300 W 50/60 Hz
Monitor
12 VDC 4.16A 50 VA * 50 W 50/60Hz
* DC voltage has no phase difference. Therefore VA = Watts.
Environmental Conditions
The instrument functions correctly in an ambient temperature of 15° C to 32° C (59° F to 89° F) with a rel-
ative humidity of 5% to 85% (non-condensing).
In accordance with the IEC regulations, no instrument failures occur in the presence of short-term ambient
temperatures as low as 5° C or as high as 40° C.
The instrument has been tested to IEC 60068-2-40 to 2000 meters. The instrument should not be used at an
altitude greater than 2000 meters.
The instrument should be placed in an area free from dust, fumes, vibrations and excessive variations of tem-
perature.
The heat generated by the instrument during normal operation is exhausted from the bottom, the front-right
and the left side of the unit.
Sufficient space (at least 6 inches) must be provided around the instrument to permit circulation of air for
cooling. The instrument must be positioned so that a waste tube can be easily connected on its right side.
The audible noise emission is a maximum of 55 dBA, which passes IEC/CEI 61010-1 :2001 Second Edition.
Storage Conditions
Store the instrument plus startup kit at 15°C to 25°C, 85% relative humidity.

Site Requirements
Reagent Specifications
Reagent specifications for the ACL TOP instrument are published separately and distributed in the reagent
packaging.
Non-IL Reagents
The use of non-IL brand reagents or supplies for testing may cause a clinically significant degradation of per-
formance and results. IL does not assume any obligation or warranty engagement concerning precision and/or
accuracy of the measurements, nor for any damage to the instrument directly or indirectly resulting from the
use of reagents, consumables and/or expendable supplies other than those produced by IL.
See Also
l Warranty

Actions Upon Delivery

Only an IL-certified representative may perform the following actions upon delivery:
l Uncrate the ACL TOP instrument.
l Make sure that the shipping list is complete.
l Make sure all materials are in proper condition.
l Install the ACL TOP instrument.
IL is not responsible for damages resulting from attempts by an employee or representative of your company
to perform any of the above actions.
See Also
l Warranty
l Site Requirements

Bringing Into Operation
Bringing Into Operation

The entire ACL TOP instrument installation process is the responsibility of an IL-certified representative.
CAUTION: The ACL TOP instrument weighs from 200-365 pounds (91-166 kg) depending on the
model. Use extreme care when moving the instrument. A total of four people should be used. Two people
should lift using the two molded handles in the rear of the unit. The third and fourth persons should each
take a front corner.
IL is not responsible for damages resulting from any attempt by any employee or representative of your com-
pany to install the ACL TOP instrument.
See Also
l Warranty
l Site Requirements

Training Requirements
The user will operate the instrument in accordance with instructions for use in this manual. Using the instru-
ment improperly may result in impairment or injury.
The operator will follow normal laboratory practices for handling biohazardous substances, including the use
of lab coats, gloves, and shield, where required.
Users who operate the ACL TOP instrument must be properly trained by Instrumentation Laboratory, or an IL
representative.
Contact your local IL representative for information about training programs and the training certification pol-
icy.
IL is not responsible for damages caused by using, or attempting to use, the ACL TOP instrument by employ-
ees, or representatives of your company or laboratory.
See Also
l Warranty
l Site Requirements

Warranty
Warranty
IL warrants to Customer that the Products will be free from defects in material or workmanship for one year
from date of delivery, in the case of instruments and ninety (90) days from date of delivery for other products
(unless a different period is specified), or IL will repair or replace the product or provide credit, at its sole
option, upon prompt notification and compliance with its instructions. IL makes no warranty and shall have
no obligation with respect to expendable or consumable parts and supplies nor with respect to damage
caused by or resulting from accident; misuse; neglect; use of parts, materials or products not furnished by IL;
or unauthorized installation, alterations or repairs to the Products. IL EXPRESSLY DISCLAIMS ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTY OF MER-
CHANTABILITY AND FITNESS FOR A PARTICULAR OR AN INTENDED PURPOSE.
IL's sole responsibility and the Customer's exclusive remedy for any claims arising out of the purchase of the
Products is the repair, replacement, or credit as described above where applicable. In no event:
1. shall the cost of the exclusive remedy exceed the purchase price;
2. shall IL be liable for any claims, losses or damages of any third party or for lost profits or any special,
indirect, incidental, consequential, or exemplary damages, irrespective of whether attributable to con-
tract, warranty, negligence, strict liability, or otherwise, even if IL has been advised of the possibility
of such damages.
See Also
l Site Requirements

Limitations and Disclaimers

Warranty Claims
Customer must inform IL of any defects found within 8 days from receipt or from discovery, in case of defects
which may not be identified in the normal inspection or which may appear at a later time.
Neglect and Misuse

The warranty does not apply to those defective instruments or materials showing defects or damage from such
as:
l Insufficient or negligent care by the customer.
l Use of the instrument by a user who has not been properly trained by IL or its representative.
l Failure of customer to follow to the instructions contained in the Manuals prepared by IL for this pur-
pose.
l Tampering with or altering the instrument.
l Repairs made by any person not duly authorized by IL.
l Misuse due to carelessness, negligence or inexperience.
l Employment of materials under heavier conditions than those for which they had been designed and
manufactured and use of the same in combination with incompatible or dangerous products.
l Failure to observe regulations relative to installation, power supply and operation of the instruments
(with particular regard to the regulations for accident prevention).
It is also understood that, following the purchase and delivery of the instrument, the customer shall be
deemed liable for any losses, damages or complaints concerning persons or things incurred by the use or mis-
use of the instrument on behalf of the customer, his employees, co-operators or others.
Damage during Transportation

Damages caused by or connected to transport are excluded. Customer shall bear all risk and cost for trans-
porting products to and from IL’s factory.
Third Party Products

Those instruments or accessories that are supplied by IL but are not of IL manufacture will only benefit from
the warranty conditions offered by the manufacturer of such products.
Safety
Instrumentation Laboratory (IL) is responsible for the safety and electrical performance of this equipment if
and only if:
l Assembly operations, extensions, adjustments, modifications or repairs are carried out by persons
authorized by IL,
l The electrical installation of the room complies with the local, state or national requirements (includ-
ing a power supply circuit with independent grounding),
l The equipment is used in accordance with these instructions for use.

Limitations and Disclaimers
“Washed” Cuvettes
The IL ACL TOP instrument cuvette was designed and manufactured as a single use product. Instrumentation
Laboratory and its authorized dealers shall not be responsible for instrument malfunction, invalid test values
or damages of any kind resulting from use of washed cuvettes.
Non-IL Brand Product

IL does not test other manufacturer reagents to ascertain their suitability for the ACL's methodology or their
level of performance on the IL ACL instruments.
The use of non-IL brand reagents or supplies for testing may cause a clinically significant degradation of per-
formance and results. IL does not assume any obligation or warranty engagement concerning precision and/or
accuracy of the measurements, nor for any damage to the instrument directly or indirectly resulting from the
use of reagents, consumables and/or expendable supplies other than those produced by IL.
IL brand reagents, consumables and expendable supplies (including, for example, cuvettes) were developed
specifically for the ACL TOP instrument’s detection systems. IL ACL TOP instrument products are tested to
assure proper performance when using plasma samples in accordance with the protocol. Each lot of IL brand
ACL TOP instrument reagents is tested against these criteria. Verification of other brands of reagent or
supplies to ascertain their suitability for the ACL TOP instrument methodology or their level of performance
on the IL ACL TOP instruments is not performed. The use of non-IL brand reagents or supplies for testing
that is not done in accordance with IL protocols may cause a clinically significant degradation of per-
formance and results.
IL does not assume any obligation or warranty engagement concerning precision and/or accuracy of the meas-
urements or for any damage to the instrument directly or indirectly resulting from the use of reagents and/or
consumables other than those produced by IL.
User-Defined Tests
A user with the appropriate security level can create new tests or copy an existing test. All responsibility for
parameter development and validation of new or copied tests belongs to you alone.
NO AGENT OR EMPLOYEE OF IL IS AUTHORIZED TO EXTEND ANY OTHER WARRANTY
OR TO ASSUME FOR IL ANY LIABILITY EXCEPT AS ABOVE SET FORTH.
See Also
l Warranty
l Site Requirements


CHAPTER 3 User Interfaces
CHAPTER 3
USER INTERFACES
User Interfaces
Click one of the following links to view the corresponding ACL TOP User Interface (UI) feature:
l Input Devices
l Output Devices
l Software – Getting Started
See Also
l LIS Configuration
l Global Definitions Setup
l Visual Styles

Chapter 3 – User Interfaces
Input Devices
Input devices include the following:
l Touch Screen
l Mouse
l Keyboard
l Bar Code reader
l 2-dimensional bar code reader
l Push Buttons
l LIS
l CD Read/Write Drive
Touch Screen
The screen is touch-sensitive. Pressing an icon or field selects it similar to selecting it with a mouse.
Mouse
The ACL TOP instrument uses a standard two-button mouse and follows the standard Microsoft™ con-
ventions for its use.
Keyboard
The ACL TOP instrument uses a standard 105 key Windows keyboard and follows the standard Microsoft
conventions for its use.
Bar Code Reader

If the sample tubes and/or the reagent bottles have bar code labels, the system scans the labels as the racks
are inserted into the AM. After the bar code reader moves away from the track where you inserted the rack,
the scanned information displays.
Two-Dimensional Bar Code Reader

See 2D Bar Code Scanner.

Input Devices
Push Buttons
The AM1 has push buttons on the front that move the bar code reader to the sample and reagent rack areas.
There is also a push button in the center front of the AM that initiates an Emergency Stop as soon as it is
pressed.
LIS
The interface to the Laboratory Information System provides a means of downloading test requests remotely.
See LIS Configuration.
CD-ROM Drive
The CD-ROM drive on the CM may be used for input. Typically it is used for software and parameters
upgrades.
See Also
l Output Devices
l LIS Configuration

Output Devices
Output devices include the following:
l Monitor – Primary output device to display test results.
l Diskette drive – Use to export configuration or data files.
l CD read/write drive – Use to export configuration or data files.
l Printer (optional) – Uses a standard interface for printing reports.
l LIS – Use to output sample results.
See Also
l Input Devices
l LIS Configuration

Getting Started
Getting Started
To use the ACL TOP software effectively, review the following topics:
l Terminology
l Layout
l Common Functions
See Also
l Input Devices
l Output Devices

Terminology
See the Glossary for more terms.
Calibration/NPP
An analytical material with a defined concentration or activity used to calibrate a test. A calibrator1 may be
calibration plasma or NPP. An NPP, or Normal Pool Plasma, is made by combining plasma from a large
number of people so that the pool acts as a representation of typical plasma. It is free of biases due to race,
sex, age, etc.
Cuvettes
Cuvette
A vessel, cell, chamber, or well in which sample and reagents are deposited, mixed, incubated and analyzed.
The cuvette cell is also called the cuvette well. Each cuvette cell has an optical path of 0.67 cm and is
designed to hold a minimum of 150 µL to a maximum of 600 µL of reaction mixture.
Cuvette Accumulator
A holding area for used cuvettes. It collects cuvettes after they leave the shuttle, but before they are dumped
into the cuvette waste drawer.
Cuvette Box
A cuvette box is a group of 10 cuvette clips packaged together for easy loading on the system (10 cuvette
clips = 100 cuvette strips = 400 cuvette cells). Cuvettes are loaded by the box.
Cuvette Clip
A group of 10 cuvette strips joined together by features incorporated in the cuvette strips themselves.
1A type of sample with an assigned value used to calibrate a test.

Terminology
Cuvette Loader
The cuvette loader is the left-most part of the instrument and is a defined area for cuvette loading that
includes the pivot arm and the indexer. The cuvette loader can hold up to 20 cuvette clips of ten strips per
clip for a total of 800 cuvette cells. The transport is a conveyor belt that transports the clips along the loader
and onto the pivot arm, which, with the help of the indexer1, positions the cuvette strips for pickup by the
cuvette shuttle.
While the analysis is proceeding, the space on the indexer left by the cuvette clips that have been moved to
the incubation/analysis areas is filled with new cuvette clips. A sensor detects when more cuvette clips need
to be placed onto the loader and an LED on the front of the instrument displays yellow when there are 3 or
fewer cuvette strips remaining, and red when the loader is empty. A message is also displayed in the Material
Alarms screen.
Cuvette Shuttle
The cuvette shuttle includes the carriage, gripper and jaw. It can position a cuvette at any slot and move it to
any other slot. To the right of the cuvette loader are 14 slots for the cuvette strips. It is here that sample pre-
dilutions and calibration dilutions are performed at ambient temperature.
C arriage
The part of the shuttle that moves the cuvette strip from the loader to the various slots.
Gripper
Moves the cuvette strip into and out of the slots. The gripper includes the jaw.
Jaw
The part of the gripper that locks on to the cuvette strip.
1The part of the cuvette loader which prepares cuvettes for pick-up by the shuttle mechanism.

Cuvette Slot
Any valid drop-off and/or pick-up point for the cuvette strip. Examples of cuvette slots are incubator slots
and ORU slots.
Cuvette Strip
Four cells molded together in a disposable plastic piece form the cuvette strip. A cuvette strip is used for the
analysis. Each cuvette strip incorporates features to clip strips together to form cuvette clips and features to
enhance handling capabilities.
Cuvette Waste Container – TOP 300 CTS only

Applies to all models except the TOP 300 CTS.
This container holds the waste cuvette strips. Used cuvette strips are moved to the right side of the AM1
where they are deposited into a cuvette waste container.
CAUTION Biohazard: Refer to local and state regulations for disposal of potentially haz-
ardous materials.
The cuvette waste container must be properly seated in the waste container area such that the cuvettes fall
directly into the waste container. The waste container must sit securely against the inner wall of the waste
area.
Improper seating of the cuvette waste container may result in cuvettes falling onto the bench or floor. The
cuvette waste area contains no sensor. It should be emptied once per day, when cuvettes reach the Max level
printed on the container, or as needed to prevent overflow.
Disposable gloves should be worn when handling waste cuvettes to avoid contact with potentially infectious
material.

Terminology
Cuvette Waste Drawer

A leak-proof five-sided container designed to be used with a disposable liner. This container holds the waste
cuvette strips. Used cuvette strips are moved to the right side of the AM and onto a cuvette accumulator
which holds 6 used strips. When the sixth strip moves to the accumulator, it drops down and causes the strips
to fall into the waste drawer.
CAUTION Biohazard: Refer to local and state regulations for disposal of potentially haz-
ardous materials.
The cuvette waste drawer must be properly seated such that the cuvette exit path from the analyzer is open
and waste cuvettes can fall freely. Improper seating of the cuvette waste drawer or use of improper waste con-
tainers may result in cuvettes jamming.
Cuvette waste liners may be autoclaved. However, sharp edges may result which could cause injury. Prior to
autoclaving, the cuvette waste liner should be placed in an autoclave bag.
Disposable gloves should be worn when handling waste cuvettes to avoid contact with potentially infectious
material.
Waste Cuvette
A cuvette that contains a completed coagulation or chemical reaction, and is ready to discard.
Incubators
Sample Incubator
A heated area to the right of the dilution area that has eight slots for cuvette strips. Sample material is
pipetted into the cuvette cells here. The temperature is maintained at 37.0° C ± 0.5° C.
Reagent Incubator
A heated area to the right of the sample incubator that has eight slots for cuvette strips. Intermediate reagents
such as APTT Cephalin are pipetted into the cuvette cells here. The temperature is maintained at 37.0° C ±
0.5° C.

LAS Terminology
Adjustment Volume
Percentage of extra liquid added to every LAS probe sample aspiration to account for volume loss due to
LAS probe inaccuracy. The IL default is 2%.
Aliquoting Area
The cuvette slots where the LAS arm aliquots the LAS samples.
Aliquoting Area Expiration Time

Time used to determine whether a sample is moved to the LAS Cuvette Holding Area. If the time exceeds the
configured setting, it is not moved.
Aspiration Point
Position on the sample tube queue where the LAS probe can access a sample tube.
External Idle Position

Position outside the instrument where the LAS probe is safe from any external component.
Interface Module (IM)

Interface Module Embedded System. Communication between the LAS instrument and the LAS track is
through an embedded interface module (IM) that is configured in the LAS Configuration screen.
LAS
Laboratory Automation System
LAS Arm
The LAS arm aspirates external samples and aliquots them into the system.
LAS Cuvette Holding Area

Cuvette slots where the LAS samples are placed in the system after the LAS arm has aspirated them from the
LAS track. It is the same as the Base TOP holding area except for the slots that belong to the LAS aliquoting
area.
LAS Manager
Software or application that coordinates all the modules (track, decapper, analyzer, etc.) integrated in an LAS.
LAS Sample
Sample provided by a Laboratory Automation System.

Terminology
Sample aspiration time

A time out, specified in the Sample Aspiration Unit, used to determine whether to aspirate an accepted tube
or release it to another instrument. Countdown starts when the tube is accepted. The default is 15 minutes.
Sample expiration time

The time used to determine whether or not the LAS sample is moved to the waste station.
LAS Status
Status of the LAS track and communications with the instrument. The statuses are as follows:
R EA D Y
LAS is ready and functioning.
U N A VA ILA B LE
LAS track is not able to provide samples automatically.
D ISA B LED
The LAS arm cannot be used and there is no communication with the LAS track.
U N K N OW N (blank)
LAS track is down or there is a communications error between the IM and the LAS track or the IM is not
responding.
R ESET QU EU E
The instrument is resetting the track queue. During this time the instrument does not interact with the LAS
track and Diagnostics is disabled.
N OT C ON N EC TED
The instrument is not an LAS instrument or there is a communication error between the CM and the IM or
the IM is down.
STOPPED
Autorun is temporarily deactivated or a controlled stop has been requested or interaction with the LAS track
has stopped. The stopped state ends when you select Run Tests (the icon or the Actions menu item) from any
screen.
LAS Track
The LAS Track transports LAS samples to the ACL TOP 700 LAS instrument. It includes the sample tube
queue and the aspiration point.
Preparation cuvettes
The number of cuvette strips to use for preparing dilutions and predilutions.

Query Point
Position at the entrance to the sample tube queue.
Sample Tube Queue

A dedicated branch of the LAS track where LAS samples that are to be processed by the instrument are
diverted from the main LAS track.
Virtual Sample Tube Queue

A software list that represents the LAS samples located at the sample tube queue. The list is maintained by
the ACL TOP 700 LAS.
Material
Cleaning material
A liquid placed in a rack and used to reduce or remove unwanted substances from the probe surfaces. The
material is typically acid or bleach-based.
Clean B diluted
A dilute cleaning solution used in many tests. To make: dilute 1 mL of Clean B with 7 mL of water. This
solution must be made up fresh each day.
Deficient plasma
A plasma-based material that is lacking certain factors necessary to complete the coagulation cascade.
Diluent
A liquid used to reduce the concentration of a sample or a reagent. See sample diluent, reagent diluent,
below.
Empty material
Material that is present on the AM but the liquid level has been detected to be below the volume error thresh-
old.
Intermediate reagent
Material that is added to the sample material to activate certain constituents of the sample but does not bring
the reaction to completion. These materials are placed in diluent track D3 and reagent tracks R1-R4 on-board
the ACL TOP instrument.
Known Material
Material that is defined and used in at least one test, calibration or QC definition.

Terminology
Placed Material
Material that is known and located in a defined position on the AM. You cannot change the material def-
inition of any materials that are placed.
QC Material
A sample-like material typically having known amounts of analyte that is used to detect changes from stable
system operation and eliminate reporting of results affected by system instability.
Reagent
A liquid material used as part of a test, that, when mixed with sample, provides the necessary constituents to
either initiate or complete the desired biochemical reaction.
Reagent Diluent
A liquid material used to reduce the concentration of reagent materials or to reconstitute a lyophilized rea-
gent.
Sample
Any material used for the sample component of a test. Typically, a sample is plasma-based material, either
patient sample or control/calibrator.
Sample Diluent
A liquid material used to reduce the concentration of sample materials.
Sample Type
Refers to the different kinds of materials that can generate data (patient, QC or calibrant).
Start Reagent
Material added to the cuvette in the ORU that acts as a trigger to start acquisition. These materials are placed
in reagent tracks R3 to R6.
Unidentified Material
Material that is defined but is not used in any test, calibration, or QC definition.
Optical Reading Unit (ORU)

ORU 1, 2, 3, 4
Slots with the optical reading units where start reagents such as APTT CaCl2 are pipetted into the cuvette
cells. It is also here that the readings are taken of the reactions occurring in the cuvette cells. Each ORU has
four reading stations for a total of 16.

See Also
l Welcome to Help
l Glossary

Visual Styles
Visual Styles
To configure the ACL TOP user interface style:
1. Select Setup > Visual Style in the menu bar.
2. Select a color in the submenu.
See Also
l User Interfaces
l Getting Started
l Layout

Layout
Each screen contains the following areas:
l Main Screen
l Menu Bar
l Toolbar
l Working Area
l Status Bar
l Information Panel

Main Screen
Main Screen
ACL TOP Family Software Main Screen
The ACL TOP Family user interface contains the following functional areas:
l Title Bar – Displays the instrument name and the screen name.
l Menu Bar
l Toolbar
l Working Area
l Status Bar
l Information Panel

Menu Bar
The ACL TOP instrument main menu bar contains the following menu options:
Instrument Menu
l Controlled Stop
l Recovery
l Resume Auto Run
l Log Out
l Exit
NOTE: The choices on the Actions menu differ depending upon what is displayed in the working
area.
Sample List Actions Menu

Configuration
l Filter
Results
l Recalculate
l Validate
l Upload
l Delete
l Find Sample
l Previous
l Next
l Select All
l Unselect All
l Filter Selection by Test Code
l Download Tests Order
l Add/Remove Tests
l Run Tests
Print Preview
l Sample Results Report
l Patient Report

Menu Bar
Print*
l Patient Report
Export*
l Patient Report
l Sample Results (EXCEL)
Raw Data Report
Patient Demographics
l Save
l Restore
Print Screen
Review
l Previous Screen
l Sample Details
l Test Details
l Results Statistics
l Simple Test Counters Statistics
l Detailed Test Counters Statistics
Analysis Menu
l Sample Area
l Reagent Area
l Diluent Area
l Sample List
QC Menu
l Results List
l Test Status List
Calibration Menu
l Status List
NPP Menu
l Status List

Setup Menu
l Vial Lists
l Material List
l Test List
l QC List
l Test Profiles List
l QC Profiles List
l Reflex List
l Auto Validation
l Revision History Report
l Import/Export
l Global Definitions
l Bar Code Definitions
l LIS
l Communications
l Sender List
l LAS Configuration ( ACL TOP 700 LAS only)
l Security
l User Security List
l Software Access Screen
l Reports
l Display
l Sample List Display Settings
l Test Programming Window
l Material Programming Window
l Languages
System Menu
l Maintenance
l Diagnostics
l Instrument Status
l Status Statistics
l General Log List

Menu Bar
Help Menu
l Help Topics
l About ACL TOP
NOTE: After you print or export a report or a list, you may not be able to perform certain operations,
such as shutting down the instrument. The system may seem to lock up. When you print or export, the
Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before
you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application
window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application win-
dow; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab
to display the Print or Export dialog box.
See Also
l Layout

Toolbar
The toolbar that appears over the ACL TOP instrument Working Area is divided into three sections: General,
Operations, and Navigation toolbars. The content of the toolbar is dynamic, depending on the context of the
Working Area. In this topic, TOP 700 LAS Sample List toolbar is used as an example:
General Toolbar
Online help is accessible in all ACL TOP instrument screens.
Help – Launches the online help.
Operations Toolbar
The Sample List operations toolbar is used to perform operations on samples and the tests associated with
them. It contains the following icons:
Sample List Display Settings
Validate
Upload
Filter
Filter in Use
Find
Add/Remove Tests
Print

Toolbar
Sample Details
Test Details
Save
Restore
Navigation Toolbar
The Sample List navigation toolbar is used to navigate among the Sample, Reagent, and Diluent areas, as
well as the QC Results List and Calibration Status List areas. It contains the following icons:
Previous Screen
QC Results List
Calibration Status List
Sample Area
Reagent Area
Diluent Area

Other Commonly Used Toolbar Icons

The following commonly used toolbar icons appear dynamically depending on the context in the Working
Area. Toolbar icons remain disabled until the configuration in the Working Area is correct for the respective
task. See Toolbar Icons.
Add
Add/Remove Material
Scan (Bar code)
Copy Test
Delete Item/Delete Material
Feasibility Test List
Perform a Maintenance Activity
Run Programmed Tests
Restriction Map
Save
View Item/View Material
Warning Thresholds

Toolbar
Icon Tooltips
When you hover the cursor over a toolbar icon, a tooltip displays the task it performs.
Moving the Toolbars

At the left side of the operations and navigation sub-toolbars are vertical bars. When you select one of these
bars, the position of the toolbar moves vertically to another position in the <screen> toolbar.
Toolbar Icon Drop-down Menu

Some toolbar icons have a small arrow on their right side.
When you select the arrow, a drop down menu appears. This drop-down menu is typically configurable, and
may also appear on the touch screen.
See Also
l Graph Icons
l Grid Icons
l Toolbar Icons
l Layout

Working Area
The Working Area is below the toolbar. It typically contains a data table or a form. There are a number of dif-
ferent data tables and forms that appear in the working area. By default, the Sample List is shown at startup.
Other lists (tables) may be viewed by selecting an icon in the navigation toolbar.
Navigation Toolbar
The navigation toolbar is dynamic. Its contents depend on the context in the Working Area.
TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and TOP 300 CTS
700 LAS TOP 500 CTS
Analysis Menu
You can select a data area from Analysis menu, as shown here (TOP 700 (includes ACL TOP Base), 700
CTS (includes ACL TOP CTS) and 700 LAS example):
These are the most commonly used data areas. There are others not listed on this menu.
Scrolling
The working area often has arrow icons on its right side and below the table that let you scroll up and down
or left and right through the table data. There are also arrow icons that go to the topmost or bottommost row
or leftmost or rightmost column of data.
Unique Identifiers
Most tables that appear in the Working Area contain a unique identifier column (for example, test code).
When you select a row, the cell in the unique identifier column appears with blue cell borders, indicating
that object has focus. See Placing Focus.
See Also
l Layout
l Sample Area
l Reagent Area

Working Area
l Diluent Area
l Reagent/Diluent Area
l Sample List
l Information Panel

Status Bar
The status bar is located below the working area.
General Log Icon
The General Log icon opens a General Log List that displays the events that have occurred.
Analyzer Status
The Analyzer1 Status displays a short description and a color indicator of the current state of the analyzer, as
follows:
Description Color of Indicator

Power-up Blue
Initializing Blinking Blue
Warming Up Blinking Blue
Ready Green
Busy Blue
Controlled Stop Blue
Error Amber
Emergency Stop Amber
Diagnostics Blinking Amber
Maintenance Blinking Amber
Connecting No indicator
Not Connected No indicator
The Connecting status indicator is used during startup. The status changes to Not Connected when the sys-
tem times out without connecting to the Analytical Module.
It typically takes up to 30 minutes for the analyzer to complete the power-up process and go to the Ready
state. However, it can take up to 60 minutes at temperature extremes.

Status Bar
LIS Status
The LIS Status displays the following states:
l Amber – Rejected
l Gray – Not connected
l Green – Connected
Auto Run Status

The Auto Run Status displays the following states:
l Amber – Stopped
l Gray – Disabled
l Green – Enabled
l Red – Error
To view a short error message, hover the cursor over the red LED. A tool tip displays the cause of the error. If
the Auto Run status is both Stopped and Error, the Stopped status displays. If Auto Run leaves the Stopped
state but remains in the Error state, the status displays Failed.
LAS Status
The LAS Status displays the following states:
l Amber – Unavailable or Stopped
l Gray – Disabled
l Green – Ready
Alarm Buttons
The following icons in the status area open a window with a table that lists alarm warnings and error mes-
sages. These are disabled until there is something to report. See Alarm Buttons.
Material Alarms
Job Frequency Alarms
QC Alarms
Maintenance Alarms
Analyzer Alarms
External Communications Alarms (LIS and LAS alarms)

See Also
l Layout
l Alarm Messages

Information Panel
Information Panel
The lowest area of the screen contains an information panel with the following:
Time To Completion
The Time To Completion area is located under the analyzer status LED. It displays the estimated time to com-
plete all currently running tests. Not all tests are scheduled at once. As tests are added to the schedule, the
time to completion updates. The blue progress bar visually represents the time to completion.
User ID
See Adding and Editing Users.
Security Level
See System Security.
Number of Entries
Number of entries on the open screen. For example, if the Material List is open, a Number of Entries value
of 131 indicates there are 131 materials in the Material List.
Current Date and Current Time

Do not change the date and time in the Control Panel. Changing them may affect material stability and
patient data. The instrument has an internal clock that resets the date and time when necessary.
See Also
l Layout

Common Functions Overview

The following functions are generally available in all areas of the instrument:
l Log in
l Focus
l Select
l Add Item
l View Item
l Delete Item
l Sort
l Filtering Data
l Find
l Save
l Restore
l Previous Screen
l Print
l Print Screen
l Run/Auto Run
l Exporting Data
l Cancel/Stop/Progress Bar
l Log Out
l Exit

Logging In
Logging In
To start the ACL TOP instrument software you must log in with your user name and password.
1. Enter your user name and password.
2. Select OK to continue logging in or select the Shutdown button to shut down the ACL TOP instru-
ment software.
If your password has a defined duration and it goes into the warning period, you are alerted on-screen and
you have the option of changing it.
l If the password is not changed you can log on for the remainder of the valid period only.
l When the password expires you are given the option to change it. If No is selected you are no longer
allowed to log on.
l If you select Yes, the change password screen displays, and you enter the new password, which is
then valid for the period defined in the User security screen.
If your password does not have a defined duration it will not expire.
See Also
l Log Out
l Adding and Editing Users
l Common Functions Overview

Placing Focus
Placing Focus on an Item

To place focus on a list item:
1. Open the list in table format (for example, Material List, Test List, Sample List, QC List, Reflex List,
etc.).
2. Click a cell in the column that contains the unique identifier. For example:
l Material Name column

l Test Code column
l Sample ID column
3. A blue cell border indicates the row has focus. Only one row at a time can have focus.
4. You can perform an operation on the item that has focus.

Placing Focus
Combinations of Select and Focus
NOTE: Do not edit the sample ID after an analytical session has started, unless you remove the rack
first.
N ot Selected / N o Focus
Focus
When a sample has focus you can obtain detailed information about the sample and its tests. Only one sam-
ple at a time may have focus.
Selected
Multi-selection is allowed. You can print, validate or upload the sample information for all selected samples.
Selected with Focus
Select and place focus to obtain detailed information about a sample and its tests. You can validate and
upload in this configuration.
U nderlined – H idden D ata
An underlined sample ID indicates there are test results that are not displayed in the Sample List. See Sample
List Display Settings to display hidden columns.
See Also
l Selecting Objects
l Selecting and Placing Focus on Samples
l Find

l Filtering Data
l Sorting Lists

Selecting Objects
Selecting Objects
You can perform actions such as add, delete, edit, print, validate or upload on items displayed on a screen by
selecting the objects, then performing the action.
Selecting an Object
To select an item:
1. Click in the left-most Select column in the row on which to perform an action.
2. A red check mark indicates the row is selected.
3. The unique identifier in the row also has focus1, indicated by a blue cell border around it.
4. You can now perform intended actions on the selected item.
Selecting All the Objects in a List

To select all the items in a list:
1. Click the Select icon in the column heading to place a red check mark in every row in the list.
2. You can now perform intended actions on all the items in the list.
See Also
l Placing Focus
l Selecting and Placing Focus on Samples
l Sorting Lists
l Filtering Data
l Find
1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus.
Only one unique identifier in a list can have focus.

Adding an Item
To add an item:
1. Select the Add icon in the toolbar.

2. The task that runs depends on the context in the Working Area. A new row is added to the table in
the Working Area.
See Also
l Adding a New Maintenance Activity
l Adding a New Material
l Adding a Test Definition

Viewing an Item
Viewing an Item
The action triggered when you select the View icon in the toolbar depends on the context in the Work-
ing Area. It typically displays detailed information on the object1 that has focus2.
See Also
l Material Definition
l Test Definition
1A data item in the Working Area of the ACL TOP application. For example, the unique identifier in a table,
a maintenance activity, or function, etc.

Deleting an Item
To delete an item:
1. Select1 one or more items in a list to delete.
2. Select the Delete icon in the toolbar.

3. Confirm the deletion when prompted.
See Test Deletion Rules.
NOTE: You may not delete IL-locked materials.
1Click in the Selection column of a table. A red check mark indicates selection. You can select more than
one object.

Sorting Lists
Sorting Lists
To sort a list:
1. Select a column heading. A small arrow appears in the column heading to indicate the column is
sorted in ascending or descending order.
2. Select the same column heading again to resort in reverse order.
3. Select a second column heading to sort the list by that criteria. The first column you sorted now
becomes the secondary sorting criteria.
The sorting condition is retained when you exit and re-enter the screen.
See Also
l Placing Focus
l Selecting Objects
l Filtering Data
l Find

Filtering Data
To filter data in the Working Area:
1. Select the Filter icon in the toolbar, or select Actions > Configuration > Filter in the menu
bar.
2. If the current view has been filtered, the icon displays in the toolbar.
3. <Optional> Select the Filter icon in the toolbar and change or remove the currently applied filter
criteria.
Filters are available for the following screens:
l Material List
l Test List
l QC List
l Sample List
l Maintenance List
l General Log List
See Also
l Sample List Filter
l Find
l Sorting Lists
l Placing Focus
l Selecting Objects

Find
Find
To find an item in the Working Area:
1. Select the Find icon in the toolbar, or select Actions > Results > Find in the menu bar.
2. Enter all or part of the search text in the Quick Search dialog box.
3. Select the Next or Previous button to locate items with similar names in the Working Area.
See Also
l Filtering Data
l Sorting Lists
l Placing Focus
l Selecting Objects

Save
Select the Save icon in the toolbar, or select Actions >Save in the menu bar to save the following
types of information:
l Auto validation information
l Bar code definitions
l Calibration data
l LIS communications configuration
l LAS configuration
l Interface Module configuration
l Material definitions
l Patient identification data
l Profile data
l QC data
l Reflex definition
l System configuration information
l Test definitions
l User security

Restore
Restore
Restore returns the system configuration to its previous saved state. Any changes made since that time are dis-
carded.
To restore the system to its previous configuration:
l Select the Restore icon in the toolbar, or select Actions > Restore in the menu bar.

Previous Screen
To view the previously displayed screen (when available):
l Select the Previous Screen icon in the toolbar, or select Actions > Previous Screen in the
menu bar.
See Also
l Toolbar
l Toolbar Icons

Print
Print
To print a report:
1. Open the appropriate screen in the Working Area.
2. Select the Print icon in the toolbar, or select Actions > Print in the menu bar.
See Also
l Formatting Reports
l Exporting Data
l Print Screen

Print Screen
To print the screen that is currently displayed:
1. Open the appropriate screen in the Working Area.
2. Select Actions > Print Screen in the menu bar.
NOTE: Except for alarm screens, Print Screen is not available when a window or dialog box is open
on top of the screen.
See Also
l Formatting Reports
l Exporting Data
l Print

Run / Auto Run
Run / Auto Run
Overview
When Auto Run is enabled, samples run automatically when PLACED. The Auto Run is enabled in the
Global Definitions Setup screen. Auto Run cannot be disabled for LAS.
The run starts automatically when all the following conditions are met:
l The AM status is READY.
l Sample status is PLACED.
l Enhanced clean is not required.
l Temperatures are in range.
l At least one ORU is enabled.
The instrument monitors these conditions at one-minute intervals. If the required conditions are not met, the
instrument retries autorun after each monitoring interval.
After Autorun starts, the instrument status remains BUSY until testing is complete.
A sample with tests that are not feasible remains in the LAS Cuvette Holding Area until all tests become fea-
sible, or until the sample expiration time elapses.
LAS alarms appear in the General Log as well as in External Communications Alarms area in the Status Bar.
Auto Run has its own status line at the bottom of the screen. The LED statuses include the following:
l Amber – Stopped
l Gray – Disabled
l Green – Ready
l Red – Not Available
See LED Status Color Codes.
To determine why Auto Run is not available, hover your mouse over the red LED to display a tool tip stat-
ing cause of the error. If the Auto Run status is both STOPPED and NOT AVAILABLE, the STOPPED status
displays. If Auto Run leaves the STOPPED state but remains in the ERROR state, the status displays NOT
AVAILABLE.

Running Tests on Manually Loaded Samples

You can only run tests when the analyzer status is READY. You can run tests programmed in one or more
sample racks.
To run tests on manually loaded samples:
l Select the Run icon in the toolbar, or select Run in the Actions menu.
NOTE: After selecting the run command, the following conditions apply:
l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running
the test. You must perform the enhanced clean before running the test. See Enhanced Clean in Per-
forming Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run command or cancel
and wait until temperatures are in range.
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput
changes. Confirm or cancel the run.
After Initiating a Test

When you confirm the run, a progress bar appears while the system is processing the run command. It dis-
appears when processing is finished.
After the run starts, other jobs can be added and executed within the same analytical session. You are not
forced to press the Run icon again after new tests are programmed within existing or new racks.
The time to completion is displayed in the status bar during test execution. See Information Panel.
The testing finishes when all feasible jobs programmed in the last started analytical session are completed.
NOT FEASIBLE tests generate alarms for each missing material.
If the job is not feasible because QC failed or there is no validated calibration, an alarm message appears. See
Calibration Setup and QC Setup Definition to see how to set this feasibility check.
When the analytical session finishes, NOT FEASIBLE tests are canceled and their status changes to
PLACED.
If, between the programming and the run, one or more tests become inconsistent or disabled, associated tests
are canceled and their status changed from PLACED to TO DO when the run begins. An alarm is also gen-
erated.
When the analytical cycle completes, the system performs a clean cycle for all probes and activates the waste
accumulator peristaltic pump to empty the contents of both the sample and reagent waste accumulators. See
Fluid Waste.
See Also

Exporting Data
Exporting Data
To export screen data to an external file:
1. Select Actions > Export in the menu bar.
2. In the Export dialog box, select a file format and destination, then select OK.
Export File Formats

l Acrobat
l Crystal Reports
l HTML 3.2
l HTML 4.0
l MS Excel 97-2000
l MS Excel 97-2000 (Data only)
l MS Word
l ODBC
l Record Style (columns no spaces)
l Record Style (columns with spaces)
l Report Definition
l Rich Text Format
l Separated Value (CSV)
l Tab-separated Text
l Text
l XML
See Also
l Importing and Exporting Definitions
l Print

Cancel / Stop / Progress Bar

The Cancel button cancels the operation currently in progress, and rolls back the changes that have occurred
up to that point.
The Stop button cancels the operation that is currently in progress.
The Progress Bar graphically represents the execution of an operation that requires time to run, and can be
canceled.
See Also

Logging Out
Logging Out
Use the Log Out command if you leave the system unattended and want to prevent access to it with your log
on name. You can log out while the system is operating.
1. Select Instrument > Log Out.
2. Select OK in the confirmation dialog box.
See Also
l Login

Exit
To close out of the ACL TOP software:
l Select Instrument > Exit in the menu bar, or select the close box in the upper right corner of the
screen.
See Also
l Starting the Instrument
l Shutting Down the Instrument
l Emergency Stop
l Controlled Stop
l Recovery

CHAPTER 4 Setup
CHAPTER 4
SETUP
Vial Lists
IL bottle types are not editable.
Adding a New Vial

To add a vial:
1. Select Setup > Vial Lists in the menu bar.
2. Select a bottle type ##1 - ##4 in the Vial Properties List.

4. Configure the vial properties in the Vial Properties Definition dialog box.
5. Select OK.
See Also

Chapter 4 – Setup
Material List
The Material List contains all the available defined materials used on the system. Before a material can be
used it must be defined. The system contains a library of definitions for materials manufactured by IL for use
on the instrument.
Accessing the Material List

To open the Material List screen:
l Select Setup > Material List in the menu bar.
Filtering the Material List

To filter the Material List:
1. Select the down arrow to the right of the Filter icon in the toolbar.
2. Select one or more of the following options on the filter drop-down menu:
l Show All
l Cal1/NPP2 and QC
l Diluents
l Reagents
l Clean
l Enabled materials
l Disabled materials
Material List Toolbar

The operations toolbar includes the following:
Select the following icons to perform the associated tasks:
Add a New Material
1Calibrator. A type of sample with an assigned value used to calibrate a test.


Material List
View Material Definition
Delete a Material
Filter
Material Restriction Map
Scan (2D bar code)
Print the Material List
Material List Actions Menu
C onfiguration
Select Configuration > Filter to open a submenu of filters used to filter the materials displayed in the Mate-
rial List Table.
Material
Select Material > Add to add a material definition.
Select Material > Delete to delete a non-IL material definition. To delete, you must first place a check mark
in the left column in the Material List Table next to the material name. A material used in a test definition
cannot be deleted before the test definition is deleted. Either remove it from the test definition, or delete the
test definition, then delete the material.
Select Material > Scan to scan a 2D bar code to update lot information and other values. (for example, ISI
value for reagents, or assigned value for calibrators).
NOTE: You may not delete IL-locked materials.

Chapter 4 – Setup
R esults
Select Results > Find Material to open the Quick Search window. Enter the material name and select OK.
Print Preview
Select Print Preview > Print Preview Material List to preview a report containing the entire Material List
before printing.
Print
Select Print > Print Material List to print a report containing the entire Material List.
Select Print > Print Material Definitions to print a report containing the selected material definitions.
Export
Select Export > Export Material List to export the Material List report. Specify the format and the des-
tination in the popup Export dialog box. See: Exporting Data.
Select Export > Export Material Definitions to export the selected material definitions.
Print Screen
Select Print Screen to print the screen currently displayed.
R eview
Select Review >Previous Screen to return to the last screen displayed.
Select Review > Material Definition to display the Material Definition screen for the material that has the
focus.
Select Review > Restriction Map to display the Restriction Map showing the types of material to place onto
each track. It also shows the types of racks that may be placed and their corresponding track positions.

Material List
Material List Table

The Material List displays what is defined for each material.
Column Heading Descriptions
Select
Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the
Select icon in the column heading to select or deselect all the rows in the table.
When you select one or more rows, the Delete toolbar icon is enabled (for non-IL materials only).
N ame
The name of the material.
Type
A material can be one of the following types:
l Intermediate reagent
l Start reagent
l Sample Diluent
l Quality Control
l Calibrator/NPP
l Clean
l Deficient Plasma
Start R eagent
A check mark indicates the material is a start reagent. A start reagent is a material that, when mixed with a
sample or a sample mixture (for example, a sample + diluent) begins the reaction.
See Restriction Map for proper vial placement.

Chapter 4 – Setup
Material R eferenced
A check mark indicates the material is used in at least one test definition. A material is also referenced if it is
configured in the Material Programming Window. Referenced materials cannot be deleted. A material
becomes non-referenced when it is no longer in the Material Programming window in a test definition, or
when the test definition is deleted.
Material On-board
A check mark indicates the material is currently placed on the system. Placed materials cannot be deleted or
edited.
Material Manufactured by IL
A check mark indicates the material was manufactured and approved by Instrumentation Laboratory. IL-
defined materials cannot be deleted.
Lot ID
An alphanumeric code that identifies where and when the material was manufactured.
Exp. D ate
The date when the material no longer meets the manufacturer’s specifications.
R efrigeration
A check mark indicates the material requires refrigeration.
Stirring
A check mark indicates the material requires stirring. Stirring is available only in rack positions 1 and 2 on
all reagent racks.
Index
The following values indicate:
l 1-500 – Material manufactured by Instrumentation Laboratory.
l 501-999 – User-defined material. Unique for each material.
A lternate Lot
A check mark indicates the material has an alternate lot defined. An alternate lot can be used to evaluate a
new material lot before the current lot expires.

Material List
Enabled Material
A check mark indicates the material is referenced by an enabled test. An unchecked box indicates the mate-
rial is included in a test definition for a test that has been disabled. See Test List .
See Also
l Reagents
l Restriction Map
l Reagent Area

Chapter 4 – Setup
Material Definition
Viewing and Adding Material Definitions

To view material definition information:
1. Select Setup > Material List in the menu bar.
2. Select the View icon in the toolbar, or double-click a material on the Material List to display
the Material Definition screen.
3. View settings on the following tabs:
l General Information tab

l Stir, Rinse & Clean Information tab
l Lot Specific Information tab
4. Select the Add icon in the toolbar to define a new material.
5. Select the Save icon in the toolbar to save your changes.
6. Select the Previous Screen icon in the toolbar to return to the Material List.

Material Definition
Configuring Reporting of INR Results

To report INR1, you must enable NPP2 and define a valid NPP value in the test definition. INR is the default
reporting unit for IL, PT-tests. The NPP default value is 0.0.
Enter the ISI3 value into the Material definition for the PT reagents as follows:
2. Place focus4 on the PT reagent, and select the View icon in the toolbar.
3. On the Lot Specific Information tab select Enable lot management.
4. Select the ISI Value option and enter the ISI value from the PT reagent package insert.

6. Select Setup > Test List in the menu bar.
7. In the Test List, place focus on the PT test code and select the View icon in the toolbar.
8. In the Test Definition screen, select Normal Pool Plasma in the navigational tree.
9. In the Normal Pool Plasma screen, select the Enable NPP option (if not selected) and edit the NPP
information as appropriate for your laboratory.
11. The ACL TOP instrument is now properly set up to report INRs.
See ISI Value.
NOTE:
l If the product lot number changes, the new ISI value from the package insert must be entered.
l If the measured result is 0, the Ratio and INR results fail.
1International Normalized Ratio. This value is used to standardize the reporting of Prothrombin Time (PT)
worldwide.
3International Sensitivity Index. This value is provided by each Prothrombin Time (PT) reagent and used TO
calculate the International Normalized Ratio (INR).

Chapter 4 – Setup
Material Definition Actions Menu
Material
Select Material > Save to save the changes to the material definition.
Select Material >Restore to restore the screen to its previous values.
Select Material >Activate Lot to activate the alternate lot.
Print Preview
Select Print Preview to display a preview of the Material Definition Report before printing.
Print
Select Print to print the Material Definition Report. The report displays the same information as the Material
Definition screen, with the fields labeled as Enabled or Disabled.
Export
Select Export to export the Material Definition Report. See Exporting Data.
Print Screen
Select Print Screen to print the screen that is currently displayed.
Review
l Select Review > Previous Screen to view the previous screen.
l Select Review > Assigned Values to view the Assigned Values window. See Assigned Values.

Material Definition
Material Definition – Toolbar

The operations toolbar for this screen includes the following:
Assigned Values (only for a material defined as a calibrator1)
Save – Saves the Material Definition.
Restore
Activate Lot
Print – Prints Material Definition Report.

Chapter 4 – Setup
Material Definition – General Information Tab
Material Index
Unique number for each material. The analyzer uses the material index value internally. IL materials have
indices of 1-500 and materials that are user-defined have indices of 501-999.
Material Name
Enter a name for a new material, or edit an existing name. Accepts a maximum of 20 alphanumeric characters.
NOTE: Changing the name of a material, invalidates its calibration. If you change the material name,
you must recalibrate the tests that use the material.
Manufacturer
Defaults to IL, but may be edited if the material is from another manufacturer. Accepts a maximum of 15
alphanumeric characters.
Category Type / Material Type

These fields define the material type. They cannot be changed for an existing material. For a new material,
select options from the category drop down list. Then select the material type from the drop down list.
C al/N PP and QC
l Calibrator/NPP1
l Quality Control

Material Definition
C lean
l Clean
D iluents
l Sample Diluent
l Reagent Diluent
R eagents
l Deficient Plasma
l Intermediate Reagent – A material that, when mixed with sample, activates certain components of
the sample, but is not enough to bring the reaction to the desired completion. These reagents are
always be followed by a start reagent. See Restriction Map for proper vial placement.
l Start Reagent – A start reagent is a material that, when mixed with a sample or a sample mixture (for
example, a sample + diluent) begins the reaction.
See Assigned Values.
Bottle Type
Use to specify the bottle size. The system calculates the actual volume of material available in the bottle
when the probe senses the presence of the liquid. For IL materials, the bottle volume is obtained from the bar
code on the bottle. When a new material is defined, the correct volume must be selected from a drop down
list.
NOTE: When materials are loaded and identified via the bar code, the system recognizes the bottle
type, and automatically updates the material definition. When manually identifying a material, make sure the
bottle size matches the defined bottle type. Mismatch of bottle size and bottle type may result in erroneous
volume tracking and handling.
The following graphic depicts the bottles and shows their volumes and maximum fill lines.

Chapter 4 – Setup
Smallest Volume/D ead Volume

The ACL TOP instrument indicates when a bottle of material can no longer be used. The liquid remaining in
the bottle when the bottle is no longer valid is defined as the throwaway material. The throwaway material
depends on both 1) the smallest volume for a material; and 2) the dead volume of a material bottle.
l Smallest Volume – For each enabled material definition in the system that is referenced by an ena-
bled test definition, the system automatically computes the smallest volume defined for it. The small-
est volume equals the smallest pipetting volume for a single pipetting step in any test where the
material is used. This volume is used by the system to compute the zero bottle volume. The system
considers as EMPTY all bottles that contain less than the smallest volume for that bottle. For example,
if the volume of liquid in a bottle is too low to perform a test: 1) the status of that material is changed
to EMPTY; 2) the on-board volume changes to 0; and 3) the bottle status changes to a red color
(status = PLACED, ERROR).
The smallest volume may be modified: 1) each time any related test definition is changed; and 2)
when you change system parameters that could affect test definition volumes (for example, dilution
parameters).
Important: Material smallest volume affects only the display of the material status (the on-board vol-
ume and the material bottle status [color]).
l Dead Volume – The unusable volume that triggers the <Material name> insufficient volume alarm.
For example: 1) there are no more bottles of the same material available on the instrument; 2) it is the

Material Definition
last available bottle; or 3) there is not enough material to execute the test.
The dead volume depends on the material bottle. Dead volume is based on the physical geometry of
the bottle, mechanical tolerances, etc. Aspirating from a bottle beyond its dead volume creates a risk
of performing partial aspirations, which may affect analytical results, or risk the probe striking the bot-
tom of the bottle.
Dead volumes have been optimized for reagent bottles located in stirred positions.
The following table lists dead volumes, including volume measurement accuracies that depend on
instrument-to-instrument variability.
NOTE: Values shown here represent estimates. Since material properties differ, actual values may
vary due to inherent differences in the physical properties of the sample or reagent within them.
Bottle Size Max. Dead Volume Non- Max. Dead Volume Volume Measurement
Stirred Stirred Accuracy
2 mL sample cup 0.15 mL N/A N/A
4 mL 0.4 mL N/A ± 0.2 mL
7.5 mL 0.8 mL N/A ± 0.3 mL
10 mL 0.8 mL 2.0 mL ± 0.3 mL
15 mL 1.3 mL 2.8 mL ± 0.5 mL
20 mL 1.3 mL 2.8 mL ± 0.5 mL
30 mL 3.5 mL N/A ± 0.7 mL
Aliquot tube (Fish- N/A* N/A
erbrand)
Aliquot tube (Cor- N/A* N/A
ning)
Cuvette 65 μL N/A
* Dead volumes for aliquot tubes cannot be determined due to variability of tube geometry, tolerance,
sample characteristics, and tube material.
l Throwaway Material – This depends on both the material smallest volume and the bottle dead vol-
ume.
Volume Tracking
The system uses the fill volume to track the available volume of material in real-time, and generates a warn-
ing when the volume reaches the defined warning threshold.
Enable Volume Threshold

Specifies the volume of material remaining that triggers low volume. The minimum allowed value is 0.3 mL
(to eliminate the possibility of having insufficient material to complete a run. The low volume warning
threshold should be established for every material based on the laboratory workload and workflow to allow
enough time to replace the material.

Chapter 4 – Setup
Enable Expiration Tracking

Option to generate a warning when the material approaches its expiration date. The expiration date is defined
in the Lot Specific Information tab. This parameter also is selectable when the lot management is disabled,
since for IL materials the expiration date is read from the bar code on the bottle.
Enable W arning Threshold

Specifies the number of days before the material expiration date to generate a warning. The Expiration Track-
ing warning threshold should be established for every material, based on laboratory needs.
On-board stability
Enable On-board Stability Tracking

Option to automatically track the stability of a material placed in the reagent area.
On-board Stability
Specifies the number of minutes, hours or days that the material remains stable while it is on the Analyzer1 in
the Diluent or Reagent area. The system generates an error and stops using that material when the defined on-
board stability time elapses. This field is available only for user-defined materials.
Enable warning threshold

Specifies the number of minutes, hours or days before reaching the on-board stability limit to issue a warning.
The low on-board stability warning threshold should be established for every material, based on laboratory
needs.
NOTE: Do not change the date and time on the host computer. This can affect material stability and
patient data. The instrument has an internal clock that resets the date/time when necessary.
Test not feasible when stability is expired

When this option is selected, the following events occur when the reagent material exceeds the on-board sta-
bility:
l Tests in the TO DO state will not run.
l Tests that are PLACED but not scheduled will not run.
l Tests that are PLACED and scheduled, but NOT FEASIBLE (required materials are not on-board) will
not run.
l Tests that are PLACED and ACTIVE (required materials are on-board) will run, and the results are
flagged.

Material Definition
l Tests that are NOT FEASIBLE (required materials are not on-board) will not run. Exception: If an on-
board material expires while a test is ACTIVE, the test will run but the results will be flagged.
l Tests that are COMPLETE remain complete.
NOTE: Rerun and Reflex tests are created and executed (if feasible) during the run session, so they
have PLACED status, and run based on the above rules.
Comments
Enter notes about the material, if desired. This field is for reference only.
Location Information
Location information is provided only when the material is on-board. This consists of a table with the fol-
lowing data columns:
l Track identifier – ID for a track
l Rack identifier – ID for a rack
l Rack position identifier – ID for a rack position
l Lot identifier – ID for a lot number
l Stirring indicator – Check mark means position has stirring
l Refrigeration indicator – Check mark means position has cooling

Chapter 4 – Setup
Material Definition – Stir, Rinse & Clean Information Tab

On this tab, define: 1) how the instrument performs rinse and clean after a material has been pipetted; and 2)
whether stirring is necessary. Select Rinse or Clean and Rinse for reagent, diluent and sample materials.
Rinse
Option to perform probe rinse operations.
This option is disabled if you select the Clean & Rinse option.
Frequency
Specifies when to perform probe rinsing. Options are:
l Between changes in material only – Default option. Rinsing is not performed between multiple, suc-
cessive dispensations of this material, but is performed between changes of material.
l After each dispensation of same material – Rinsing is performed between each dispensation of the
same material.
R inse time
Time allocated for the probe rinsing operation.
l Minimum: 1 sec.
l Maximum: 5 sec.

Material Definition
l Default: 1 sec.
See Analytical Cycle Definition Screen.
Enable agitation
When this option is selected, rinse solution is aspirated into the probe and a scrubbing action cleans the
inner probe walls. This is repeated the number of times you configure.
Stirring required
Option to stir the material. You must place a magnetic stir bar (IL Part Number 09746610) in the bottle with
the fluid. The bottle must be placed in reagent rack positions R1 or R2. If the bottle is placed into a rack posi-
tion that does not support stirring, the instrument issues a warning.
Clean & Rinse

Option to perform probe clean and rinse operations.
This option is disabled if you select the Rinse option.
N umber of clean & rinse cycles

Configure the number of clean and rinse cycles to perform.
Clean Cycle
C lean material
Select a system clean material in the drop down list.
NOTE:
l IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B
diluted bottle becomes empty, the instrument performs an emergency stop, and all work in progress is
lost. To avoid loss of work, place multiple bottles of Clean B diluted on-board the instrument. See
Restriction Map for correct placement.
l The absence of the selected clean material from on-board the instrument makes the test that uses the
material for which the clean is defined NOT FEASIBLE.
N umber of aspiration cycles

Configure the number of times to run the clean and rinse cycle.
C lean airgap
Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean
material and ensures accurate volume delivery.
l Minimum: 0 µL
l Maximum: 250 µL

Chapter 4 – Setup
l Default: 15 µL
C lean volume
Volume of clean material in microliters that the probe aspirates during the clean and rinse cycle.
l Minimum: 0 µL
l Maximum: 200 µL
l Default: 130 µL
C lean transport volume

Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and
ensures accurate volume delivery. This is not selectable for system clean.
l Minimum: 0 µL
l Maximum: 250 µL
l Default: 0 µL (Zero indicates not used.)
C lean total volume

Sum of the clean volume, clean airgap and clean transport airgap.
NOTE: The clean total volume must not exceed the maximum probe volume, or 250 µL.
H old time
Period of time the clean material is held in the probe before it is agitated or dispensed to waste.
l Minimum: 0 sec.
l Maximum: 60 sec.
l Default: 0 sec.
Enable agitation
C lean material volume for all cycles

Volume of clean material required for the configured number of aspiration cycles.
Rinse cycle
Frequency

Material Definition
l Between changes in material only (default) – Rinsing is not performed between multiple, successive
dispensations of this material, but is performed between changes of material.
same material.
R inse after clean time

l Minimum: 1 sec.
l Maximum: 5 sec.
l Default: 1 sec.
See Analytical Cycle Definition Screen.
Enable agitation

Chapter 4 – Setup
Material Definition – Lot Specific Information Tab
Enable Lot Management

Check this option to enable the fields on this tab.
You can define two different lots of a material: an active lot and an alternate lot. If lot management is ena-
bled, the material is identified by both name and lot number. This option must be enabled if an ISI value is
used with a reagent. When this option is not selected, the material is identified by name only, and either lot
may be placed on the system. Both lots are considered the same, and can be used for either an active lot
study or an alternate lot study. Lot specific data located in this screen can be viewed and edited only when
lot management is enabled. The system tracks the materials used with their corresponding lot tracking infor-
mation for every test performed on the system, including calibration, QC, and patient sample tests. See Ena-
ble Alternate Lot.
Active Lot
Lot ID
A Lot ID is mandatory if lot management is enabled. The material identification appears on the bar code
label. When using bar coded materials, if the lot ID on the bar code label does not match the lot number spec-
ified in this field, the system does not use the bar code information, and the bottle position on the CM dis-
plays a question mark to indicate MATERIAL PLACED BUT UNIDENTIFIED.

Material Definition
Expiration D ate
The expiration date of a material is printed on its label. When using bar coded materials, if the expiration
date on the bar code does not match the expiration date specified in this field, the system will not use the bar
coded information, and the bottle position on the CM will display a question mark to indicate MATERIAL
PLACED BUT UNIDENTIFIED.
Enable Extended Expiration D ate

If IL extends a material expiration date, select this option and enter the new expiration date. If the extended
expiration date is earlier than the original expiration date, the system issues an error, and the new date is not
saved.
ISI Value
Available only if the material type is reagent. If you select this option, enter the manufacturer's ISI value
from the reagent insert sheet to calculate the INR value. By default, this field is blank.
ISI Value
ISI (International Sensitivity Index) specific to the lot of thromboplastin reagent used by Prothrombin Time
(PT) tests. The ISI value compares the behavior of a specific lot of PT reagent with the International Ref-
erence Thromboplastin. The ISI value must be entered in the material definition of the PT reagent in order to
obtain correct INR (International Normalized Ratio) values. Failure to edit the ISI default value causes incor-
rect INR results. A warning is generated when the ISI value is missing. If the corresponding lot number is
changed, this value becomes blank, and you must enter the ISI value for the new lot number found in the
new package insert.
INR Formula
l INR = (PT Patient / PT Normal)ISI value
l PT PATIENT = Patient’s PT in seconds
l PT Normal = PT Normal Pool Plasma value, dependent on user-specified NPP mode
l ISI Value = International Sensitivity Index from the current lot number of the PT reagent used
CAUTION: Important Warning
l If the INR calculation is not properly set up, erroneous patient results may be reported.
l If the product lot number changes, insert the new ISI value from the package.
See Configuring Reporting of INR Results.
Lot Specific C omment

Enter a comment for this lot.
Last Modification D ate/Time

Date and time the lot information was last changed.
Enable Alternate Lot

An alternate lot is used to perform parallel studies. The results of an alternate lot study are not used by the

Chapter 4 – Setup
system. You cannot validate patient results generated by the alternate lot.
Select this option to use another lot of the same material. The fields for alternate lot are the same as for active
lot. The lot ID must be different than the active lot ID. If the last 4 digits of the ID are the same for both lots,
the expiration dates must be different or an error is issued.
Tests that require a calibration allow an active lot calibration and an alternate lot calibration to be valid at
the same time. This allows the results from the new lot of material to be compared to its own calibration
curve.
You can automatically activate the alternate lot if the material is not on-board and if both the active and
alternate lots have been enabled and defined for the material.
When the alternate lot has been automatically activated, the lot information is copied from the alternate lot
to the active lot, the existing active lot data is archived, the alternate lot fields are set to their default values
and the alternate lot is disabled. Use the Actions menu or the Activate Lot icon to activate the alter-
nate lot.
If the material that is being activated is a calibrator, the calibrations obtained with an active lot of calibrator
always remain active and can always be validated (even when that lot does not exist any more). Calibrations
obtained with an alternate lot of calibrator become active when the alternate lot becomes active. All other
existing active and validated tests that were run with the previous active lot of calibrator, but were not run
with the alternate lot of that calibrator, are not affected. They remain active and validated, although obtained
with an active lot that is no longer active.
NOTE:
l Only active calibrations can have a calibration lot that is no longer in the system. Validated alter-
native lot calibrations become unvalidated when any of the lots of the calibrator or reagents used for
them are removed from the system.
l The recalculation function is not available for calibrations performed using an old calibrator lot or an
old reagent lot.
l To manually switch from alternate lot to active lot, you must first disable the alternate lot.
l The active and alternate lots cannot have the same lot number.
l When you manually disable the alternate lot of QC material, all QC data associated with that lot is
lost.
Test not feasible when lot is expired

Option to cancel tests that use this material after the lot expires.
See Also
l Review and Validation
l Reviewing QC Results
l Reviewing Test Results

Assigned Values
Assigned Values
Overview
The Assigned Values window for a material is accessible only when the following conditions are met:
l Calibration – The material is used in a test definition for calibration/NPP1. The assigned value field
for a calibration material is also available in Test Definition – Calibration.
l QC – The material is used in a Quality Control definition in the QC List. The assigned value for a
quality control material is also available in QC Definition.
Viewing, Editing, Printing, Exporting Assigned Values

To view assigned values:
2. In the Material List, double-click a material of type Quality Control or Calibrator/NPP to open the
Material Definition screen.
3. Select the Assigned Values icon in the toolbar to open the Assigned Values dialog box for
the selected material.
NOTE: If you enable lot management, you must enter and save the lot number and expiration
date on the Lot Specific Information tab. Failure to do this disables the Assigned Values
icon.
4. To edit assigned values, double-click a cell in the appropriate column, edit the value, and select the
OK button.
5. To print assigned values, select the Print button and follow the prompts.
6. To preview assigned values before printing, select the Preview button.
7. To export assigned values, select the Export button and follow the prompts.

Chapter 4 – Setup
Assigned Values for Calibration
Assigned values for the active lot of a calibrator1 are edited in the Active Lot column.
Assigned values for the alternate lot of a calibrator are edited in the Alternate Lot column.

Assigned Values
Assigned Values for QC
Target mean values for the active lot of control are edited in the Active Lot – Mean column. The SD values
are edited in the corresponding Active Lot – SD column.
Target mean values for the alternate lot of control are edited in the Alternate Lot – Mean column. The SD
values are edited in the corresponding Alternate Lot – SD column.
See Also
l QC Setup Definition

Chapter 4 – Setup
Test List
This screen contains a list of tests that are performed on the ACL TOP instrument. The information displayed
in the Test List table is imported from the Test Definition screens.
Accessing, Printing and Exporting the Test List

To open the Test List:
2. To print preview the Test List, select Actions > Print Preview > Print Preview Test List in the menu
bar.
3. To print the Test List, select the Print icon in the toolbar, or select Actions > Print Test List in
the menu bar.
4. To export the Test List, select Actions > Export > Export Test List in the menu bar.
Filtering the Test List

To filter the Test List:
2. Do one of the following:
l Select Actions > Configuration > Filter > Enabled Tests and/or Disabled Tests in the
menu bar to toggle those filters on and off.
l Select the arrow on the Filter icon in the toolbar, and select Enabled Tests
and/or Disabled Tests to toggle those filters on and off.
3. The filter configuration persists.
Viewing a Test Definition

To view a test definition:
2. Double-click a test in the Test List.
3. Select an item in the Test Definition navigation tree to view the test settings in the respective screen.
4. Select the Previous Screen icon in the toolbar to return to the Test List.

Test List
Adding/Creating a User-Defined Test

To create a new user-defined test:
1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper secu-
rity level to perform the required actions.
3. In the Test List, select the Add icon in the toolbar, or select Actions > Test > Add in the menu
bar.
4. Enter a unique Test code and Test name in the Non-IL Test Definition – General Information screen.
5. Select the required test definition items in the navigation tree and configure the required fields in the
respective screens.
7. Select the Previous Screen icon in the toolbar to return to the Test List. The new test appears
in the list.
NOTE: All responsibility for parameter development and validation of new or copied tests
belongs to the user alone.
Copying a Test
To copy a test:
3. Select1 a test in the Test List.
4. Select the Copy icon in the toolbar, or select Actions > Test > Copy in the menu bar.
5. The copied test opens in the Test Definition screen. All test definition information except the Test
Code, Test Name and LIS number is copied to the new test definition.
NOTE: All responsibility for parameter development and validation of new or copied tests
belongs to the user alone.
one object.

Chapter 4 – Setup
Deleting a Test Definition

To delete a test:
2. Select1 a user-defined test in the Test List.
3. Select the Delete icon in the toolbar, or select Actions > Test > Delete in the menu bar.
4. Confirm the deletion in the Deleting Test Definition dialog box. This dialog box lists all the ref-
erences associated with that test that will also be deleted.
5. See Test Deletion Rules.
About Deleting Test Definitions

Tests referenced elsewhere in the system cannot be deleted unless the references are also deleted (for example,
parent/shadow, paired test, imported test, reflex rules, QC, test profile, Test Programming window, and Sam-
ple List). You may manually delete references to tests, or allow the instrument to delete them automatically.
If tests are referenced in other locations, the system displays a message listing the references to delete.
Test Deletion Rules

The rules for deleting a test from the system are as follows:
l IL-locked tests cannot be deleted in the Test List.
l A parent test cannot be deleted until all of its shadow tests are deleted.
l A test whose calibration results are imported by another test cannot be deleted until all tests that
import the test are deleted.
l The master test in a paired test definition cannot be deleted until the paired test partner is deleted.
l A test referenced in one or more QC definitions cannot be deleted until the QC definitions ref-
erencing the test are deleted.
one object.

Test List
l A test referenced in one or more test profile definitions cannot be deleted until the references or pro-
files are deleted.
l A test referenced in one or more reflex rules cannot be deleted until the references or rules are
deleted.
l A test referenced in the Test/Profiles Programming window cannot be deleted until it is removed from
the programming window.
l A test referenced in the Sample List Display Settings cannot be deleted until it is removed from the
display settings.
Enabling or Disabling a Test

To enable or disable a test:
2. <Optional> Filter the Test List by Enabled Tests or Disabled Tests, or both
3. Select one or more tests in the Test List.
4. Select the Enable/Disable Test icon in the toolbar, or select Actions > Test > Enable/Disable
in the menu bar.
5. If a test is enabled, it becomes disabled. If disabled, it becomes enabled. A check mark in the Test
Status column in the Test List indicates the test is enabled.
NOTE:
l A test referenced elsewhere cannot be enabled/disabled until the references are disabled/enabled (for
example: parent/shadow, paired test, imported test, reflex rules, test profile, Profiles Programming
screen, or Sample List Display Settings). References must be manually enabled or disabled.
l The Promote function on the Actions > Test menu is available only to IL test developers.
Finding a Test
To find a test in the Test List:
2. Select Actions > Results > Find Test in the menu bar.
3. Enter all or part of the test code in the Quick Search window.
4. Select Next or Previous to find and place focus1 on the test code in the Test List.

Chapter 4 – Setup
Test List Toolbar

The operations toolbar for the test list screen includes the following:
Add a new test
View a test definition
Delete a test
Copy a test
Enable/Disable test
Filter the Test List
Print the Test List
Test List Actions Menu

The Actions menu for the test list is as follows:

Test List
Test List Screen
Select
Selecting one row enables the Copy, Delete and Enable/Disable Test toolbar icons.
C ode
Unique identifier for the test. The maximum length is 8 characters.
N ame
Full name of the test. The maximum length is 20 characters.
IL Test
A checkmark indicates a test developed by Instrumentation Laboratory.
LIS
Laboratory Information System test identifier used to communicate between a host computer and the ACL
TOP instrument.
Tests with an extended acquisition mode enabled have a unique LIS number for the test run in this mode.
Tests with parallelism enabled have a unique LIS number for the test run in the parallelism mode.
The maximum number of LIS numbers per test definition is three: 1) standard acquisition mode; 2) extended
acquisition mode; and 3) parallelism mode.
A cq. Time
Standard Acquisition Time = The number of seconds the instrument spends acquiring data during a test.
N o. R eps
Number of replicates the test performs on patient and/or QC samples. The default value is 1.
U nit
Primary unit for the measured result in the test.

Chapter 4 – Setup
N ormal R ange
Range of values the user has defined as the normal range of test results for patients in their population. The
default range is -999999.9 to 999999.9.
C onsistency
A check mark indicates the test definition is consistent. Inconsistencies must be corrected before a test can
run.
Test Enabled/D isabled

A check mark indicates the test is enabled to run on the instrument.
A test referenced elsewhere cannot be enabled/disabled until the references are disabled/enabled (for exam-
ple: parent/shadow, paired test, imported test, reflex rules, test profile, Profiles Programming screen, or Sam-
ple List Display Settings). References must be manually enabled or disabled.
See Also
l Test Definition

Test Definition
Test Definition
Viewing a Test Definition

To view a test definition:
3. Select an item in the Test Definition navigation tree to view the test settings in the respective screen.

Chapter 4 – Setup
Defining a New Test

See user-defined test disclaimer.
To define a new user-defined test.
2. Select the Add icon in the toolbar on the Test List screen.
3. Expand and select an object in the Test Definition navigation tree (for example, Sample pre-dilution,
Wavelength definition, etc.).
4. In the screen that opens, configure the test parameters.
NOTE: A user with the appropriate security level can create new tests or copy an existing test. All
responsibility for parameter development and validation of new or copied tests belongs to you alone.

Test Definition
Test Definition Operations Toolbar

The Test Definition toolbar consist of, but is not limited to, the following:
Apply Consistency Checks to determine whether the current test definition information is con-
sistent.
Save the test definition
Restore the previously saved information.
NOTE:
l A user with the appropriate security level can create new tests or copy an existing test. All respon-
sibility for parameter development and validation of new or copied tests belongs to you alone.
l If you change the parameters of a user-defined test such that the analytical performance of that test is
affected, you must recalibrate that test.
l You cannot edit the test definition of a test with a status of PLACED.
See Also
l Test List
l General Information
l Analytical Cycle Definition
l Data Reduction Parameters
l Result Unit Definition
l Calibration
l Parallelism
l Normal Pool Plasma
l Rerun Rules

Chapter 4 – Setup
General Information Screen
Accessing the General Information screen

To open the General Information screen for a test:
2. Do one of the following in the Test List to open the Test Definition screen for a test:
l Double-click a test.
l Place focus1 on a test code, and select the Test Definition icon in the toolbar.
l Select2 a test, and select Actions > Review > Test Definition in the menu bar.
3. Select General Information in the navigation tree to view the General Information screen.
4. <Optional> Edit the General Information screen.
one object.

General Information Actions Menu

Test
l Select Test > Apply Checks to apply consistency checks to the test definition.
l Select Test > Save to save the test definition.
l Select Test > Restore to restore the test definition to the previously saved version.
Print Preview
Previews the Test Definition report containing the data displayed on the General Information screen before
printing.
Print
Prints a Test Definition report containing the data displayed on the General Information screen.
Export
Exports the test definition data displayed on the General Information screen.
Print Screen
Prints the General Information screen.
R eview
Select Review > Previous Screen to return to the Test List.

Chapter 4 – Setup
General Information
Test code
Unique mnemonic for the test. The maximum length is 8 alphanumeric characters.
Test name
Complete name of the test. The maximum length is 20 alphanumeric characters. The test name is printed on
the Patient report.
LIS number
Laboratory Information System identifier (used in host communication) for a test when using the standard
acquisition time. The following extensions are appended to the test code for the LIS number:
l 1 – Standard tests
l 2 – Extended tests
l 3 – Parallelism tests
For example, PT-RP has a test number of 13, a standard test LIS Number of 131, an extended test LIS number
of 132, and a parallelism test LIS number of 133.
NOTE: The LIS code must be programmed before analyzing samples that require test results to be
uploaded to the host. Samples run before programming the LIS codes are not uploaded.
Test number
Unique numeric identifier for the test. Consistency requires all user-defined and IL locked tests to have a
value in this field. Values are as follows:
l 1-250 – IL locked tests
l 251-500 – User-defined tests
l 501-750 – IL locked tests for investigation only.
When creating a new test or copying an existing test, the next available test number is automatically
assigned to the test.
IL test
Read-only. If checked, the test is an IL-defined and locked.
For investigation only

Read-only. If checked, the test is for investigational use only.

Assay
A ssay release number
Indicates whether the assay has been modified from the last parameter release. The maximum length is 50
alphanumeric characters.
Test modification number

Automatically increments by a value is one each time this test definition is saved.
U ser revision comment

Comment stating the reason a change was made to the test definition. The maximum length is 50 alpha-
numeric characters.
IL revision comment
For IL use only. Comment stating the reason a change was made to the test definition. The maximum length
is 50 alphanumeric characters.
Manual validation required

Option to force manual validation of test results before results can upload to the LIS.

Chapter 4 – Setup
Enable as Shadow Test

Shadow tests are used when multiple test results are derived using the same raw data.
Example
Prothrombin Time (PT – the Parent Test) and Fibrinogen (FIB – the Shadow Test) where the same coag-
ulation curve can be used to give two different results: 1) the clotting time; and 2) the amount of fibrinogen
in the sample.
Parent test
Test that generates the raw data from which multiple results are obtained (using different algorithms to com-
pute the results). When enabled, the Parent test drop down list becomes active.
Inherit LIS numbers from parent test

A checkmark indicates the LIS number from this test is identical to the parent test.
Shadow Test Rules
l A shadow test must have a parent test assigned to it.
l A parent test may have more than one shadow test associated with it. The maximum number of
shadow tests is 5.
l A parent test definition cannot be deleted until after all of its shadow test definitions are disassociated
from the parent test (Disable the Enable as shadow test option and deselect the parent test. Or delete
the shadow test).
NOTE: If you enable a test as a shadow test, you can configure a delay time for the shadow test. See
Analytical Cycle Screen.

Enable as Paired Test

Paired tests are used when a meaningful result can be generated only by comparing the results of two dif-
ferent tests, such as an activated form of a test against a non-activated form.
Example
Activated Protein C Resistance (aPCR) ratio result that compares the activated aPCR measured result against
the non-activated aPCR measured result.
Master paired test

Option to select a test whose results are required to generate the reported result. A paired test uses the meas-
ured results from two tests and their corresponding NPP1 values to compute the result. When enabled, the
Master Paired Test drop down list becomes active.
Enable Paired Test D ependency

When this option is enabled both tests of the pair run simultaneously, and both results are used to generate
the reported result. The second test of the pair must start while the first test is active.
When this option is disabled the paired test results are computed only when the master test runs and there is
a result for the partner test on the patient sample.
Example
Lupus anticoagulant Screen (LAC-S) and Lupus anticoagulant Confirm (LAC-C) paired test. These tests do
not need to be ordered together. LAC-C may only be required if there is a questionable LAC-S result. You
could request LAC-C later and the result is used with the previously run LAC-S to calculate a ratio.
Paired Test Rules
The master test of a paired test definition:
l Cannot be enabled until the paired test partner is enabled, regardless of whether it is an independent
or dependent test.
l Cannot be disabled until the paired test partner is disabled, regardless of whether it is an independent
or dependent paired test.
l Can be enabled regardless of whether the master test is enabled.
l Cannot be deleted until the paired test partner is deleted, regardless of whether it is an independent or
dependent paired test.

Chapter 4 – Setup
Consistency Check
Indicates whether the test definition is consistent, meaning the test can run as defined. If a test is not con-
sistent, the inconsistency must be corrected before the test can run. See Consistency Check.
NOTE:
l If you change the parameters for your user-defined tests so the analytical performance of that test is
l A user with the appropriate security level can create new tests or copy an existing test. All respon-
sibility for parameter development and validation of new or copied tests belongs to you alone.
See Also
l Calibration
l Parallelism
l Rerun Rules

Analytical Cycle Definition
Overview
The Analytical Cycle Definition screen allows the test developer to do the following:
l Select the primary wavelength that produces measured results.
l Select the acquisition time used to acquire data.
l Set up the loading cycles required to obtain a reaction curve.
l Enable the extended mode.
l Select the number of replicates.
Adding a Material Load Cycle Definition – for user-defined tests

To add a material in a user-defined test:
2. Do one of the following in the Test List to open the Test Definition screen for a test:
l Double-click a user-defined test.
l Place focus1 on a user-defined test code, and select the Test Definition icon in
the toolbar.
l Select2 a user-defined test, and select Actions > Review > Test Definition in the menu
bar.
3. In the Test Definition screen, select Analytical cycle definition in the navigation tree.
4. Select the Add icon in the toolbar. The Material/Sample Load Cycle Definition window opens.
5. Select materials in the Material list in the same order they are to be used.
See Creating a user-defined test.
one object.

Chapter 4 – Setup
Deleting a Material Load Cycle Definition – for user-defined tests

To delete a material from the analytical cycle:
2. Double-click a user-defined test in the Test List.
3. In the Test Definition screen, select Analytical cycle definition in the navigation tree.
4. In the Load cycle table, select1 the material to delete.
Analytical Cycle Definition Screen Toolbar

Apply Consistency Checks to determine whether the current test definition information is con-
sistent.
Save the test definition
Restore the previously saved information.
Add a material to a user-defined test. Opens the Material/Sample Load Cycle Definition win-
dow.
View the Material/Sample Load Cycle Definition window for the material with focus2 in the
Test List. Applies to the load cycle.
Delete a material from the load cycle. See Deleting a Material Load Cycle Definition.
one object.

Analytical Cycle Definition Screen
Acquisition – wavelength
Primary wavelength
The primary wavelength determines the optical wavelength that is used to monitor the reaction and to
produce a result. The options are:
l 405 nm – Typically used for chromogenic tests.
l 671 nm – Typically used for coagulometric tests.
The default option when creating a test is 671 nm.
Acquisition – time
Standard time
Acquisition time during which enough data points are collected to determine the clotting point or reaction
rate for the majority of samples. The acquisition time is expressed in seconds. The raw data may store a max-
imum of 6000 data points, which corresponds to 600 seconds of data read every 1/10th of a second. For
acquisition times greater than 600 seconds, the sample rate (the amount of time between each data point) will
increase
l Minimum: 20 seconds
l Maximum: 1800 seconds
l Default: 30 seconds.

Chapter 4 – Setup
NOTE: For user-defined tests, if a test imports the raw calibration data from another test, you can con-
figure the standard time for the test that is importing the calibration, with the restriction that the standard
time must be less than or equal to either the standard time or the extended time, if enabled, of the test whose
calibration is being imported.
D elay time
The delay time specifies the interval of data to be ignored by data reduction when calculating the result. The
delay time is part of the acquisition time.
l Minimum: 0 seconds
l Default: 3 seconds
NOTE: For user-defined tests:

l If you enable a test as a shadow test, you can configure the delay time for the shadow test inde-
pendently of the parent test.
l If a test imports the raw calibration data from another test, you can configure the delay time for the
test that is importing the calibration.
l Delay time is not displayed in reaction graphs.

Enable extended test mode

Option to collect data for a longer time period.
Extended time
When configured for extended acquisition, data is collected for a longer period of time compared to the stand-
ard acquisition, to be able to determine the clotting point for samples that have prolonged clotting times. If
the extended test mode is enabled, the extended time must be greater than the standard time. The default is
30 seconds
The extended test mode must be enabled for a calibration to run using extended acquisition time.
The extended test mode must be enabled for parallelism to run using extended acquisition time.
NOTE: For user-defined tests, if a test imports the raw calibration data from another test, you can con-
figure the extended time for the test that is importing the calibration, with the restriction that the extended
time cannot be greater than the extended time, if enabled, of the test whose calibration is being imported.
LIS number
This field displays the extended mode LIS number of the test. The LIS number for an extended test must be
unique.
Test code
This field displays the extended mode test code of the test. The extended test code is the test code appended
by the character defined in the test mode extension area of the Global Definitions screen.
Load cycle
N umber of replicates
This allows for selection of the number of times the test is to be repeated on a sample. The default value is 1;
the maximum value is 2.
Load Cycle Table
The Load Cycle table contains read-only information populated from the Material/Sample Load Cycle Def-
inition screen. (See Adding a Material Load Cycle Definition.) The display order is the order materials are
added to the reaction cuvette. Double-click the material name to access detailed material information, or

Chapter 4 – Setup
View 1 the material and select the View icon in the toolbar, which opens the Material/Sample
Load Cycle Definition window.
NOTE: If you enable a test as a shadow test, you can view the Analytical cycle fields for the shadow
test but you cannot edit them.
Total cuvette volume

Total Cuvette Volume indicates the total volume of reaction mix as defined in the Load Cycle table. The
minimum volume required is 150 μL. The maximum volume is 600 μL.
l The total of all liquid volumes cannot be less than 150 μL, the volume of liquid required to fill the
optical window on the cuvette cell.
l If you change the parameters for a user-defined test, so that the analytical performance of that test is
one object.

Material/Sample Load Cycle Definition Screen
Material
List of materials that have been defined for use on the system. Select materials from the drop-down list.
NOTE:
l The intermediate and start reagents of a test that imports the raw calibration data from another test
must be the same as the intermediate and start reagents of the test that is imported.

Chapter 4 – Setup
l When defining the first load cycle, the material must be either sample or a sample diluent. When defin-
ing the last load cycle, the material must be a start reagent.
l IMPORTANT – Many IL-defined tests use Clean B diluted as the clean material. If the Clean B
diluted bottle becomes empty, the instrument performs an emergency stop, with the consequent loss of
all work that was in progress. To avoid this, place multiple bottles of Clean B diluted on-board the
instrument. See Restriction Map for correct placement.
Aspiration information
This area defines the arrangement of volumes in the probe is as follows:
H ead volume
Amount of sample volume to aspirate for the purpose of priming the probe. This sample material is not deliv-
ered to the cuvette for testing.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 0 μL
A irgap
Amount of air to aspirate immediately before aspirating sample, separating the sample and rinse, or, if a head
volume is used, sample and head volume. It acts to prevent rinse contamination and ensure accurate volume

delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL
H ead volume airgap

Volume of air (0 – 250 µL) that is aspirated before the head volume. This field defaults to the airgap if the
head volume is greater than zero; otherwise this field is zero.
Material/Sample volume
Volume of material or sample in microliters (0 – 250 µL) that is delivered to the cuvette.
Transport airgap
Volume of air aspirated after the sample volume. It acts to prevent material loss during probe movement and
ensure accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL
Total volume
Sum of the volumes and airgaps for the specified material. This field is read-only and is computed by the sys-
tem based on the total of the load volumes.
Dispensation information
Enhanced dispense
Option to improve reagent mixing in the reaction cuvette when a material is added. This dispense option is
key to the optimal development of test parameters where a fast mix is required.
Enable mix
Option to mix the contents of the cuvette cell. Mixing is done by re-aspirating and dispensing a quantity of
material in the same cell.
Mix
The mix volume percentage is used to calculate the volume of material that is aspirated from the cuvette cell
and redispensed into the same cuvette cell to facilitate a mix. The mix volume is calculated as:
l Mix volume = (total cuvette volume – cuvette dead volume) mix %
l Minimum: 25%
l Maximum: 100%
l Default: 50%

Chapter 4 – Setup
Rinse time after mix

Amount of time to rinse the probe after mixing is completed.
l Minimum: 1 second
l Default: 1 second
Number of cycles
This is the number of mix/rinse cycles to be performed.
l Minimum: 1 cycle
l Maximum: 3 cycles
l Default: 1 cycle
NOTE: To perform a mix, a minimum of 100 μL of liquid must be in the cuvette cell.
Enable incubation time

Select to enable incubation of the material. Incubation may be required for warming the cuvette contents or
to allow sufficient time for a reaction to occur.
Incubation range
The incubation range is the minimum and maximum amount of time in seconds (20-1800) the material should
remain in the cuvette before another material is added. The instrument automatically applies a 20-90 second
incubation range to sample or reagent loading steps that do not have incubation enabled.
Rinse
Time
Length of time to rinse the probe after material delivery when the Enable mix option is disabled.
l Minimum: 1 second
l Default: 1 second
Enable agitation
Causes the instrument to scrub the internal probe walls by moving the rinse material up and down inside the
probe.
l Minimum: 1 second
l Default: 1 second

Clean & rinse

Option to define a clean and rinse cycle for the sample or any reagent listed in the Analytical Cycle screen.
For IL-locked tests, this is a user-definable field when the default for that test has Rinse enabled (sample load
cycle only). This option allows you to configure sample probe cleaning when sample materials known to
have carryover1 issues are in use.
C lean and rinse cycles

Select how many times you want the Clean & Rinse Cycle performed.
C lean material
Select a clean material from the drop down list of defined clean materials.
A spiration cycles
Select the number of times to aspirate the clean material.
C lean airgap
Enter an airgap from 0-250 μL.
C lean volume
Enter a volume from 0-250 μL.
C lean transport airgap

For non-system clean. Enter an airgap from 0 μL to 250 μL. For system clean this field is disabled since the
probe is not required to travel across the instrument, but rather remains over the clean station.
C lean total volume

The Clean total volume is a display-only field showing the total volume in the probe in μL. This is the sum
of clean volume, clean airgap and clean transport airgap.
NOTE:
l IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B
all the work that was then in progress. To avoid this, place multiple bottles of Clean B diluted on-
board the instrument. See Restriction Map for proper vial placement.
l The clean total volume must not exceed the maximum probe volume, or 250 µL.
l When using a clean material other than system clean, the clean material must be placed in the same
area as the load cycle material. Thus, if the rinse and clean is enabled for a sample, the clean material

Chapter 4 – Setup
must be placed in a diluent rack in the Sample Area. If it is enabled for a reagent, you must place the
clean material in a diluent rack in the Reagent Area.
H old time
Enter the length of time, 0-60 seconds, you want the clean material held in the probe to allow longer contact
with the clean fluid.
Enable agitation
Click to enable. Agitation scrubs the internal probe walls by moving the clean material up and down inside
the probe.
l Minimum: 1 second
l Default: 1 second
C lean volume (all cycles)

Total volume of the clean material.
NOTE: The clean total volume must not exceed the maximum probe volume, or 250 µL.
Frequency
l Between changes in material only (default) – Rinsing is not performed between multiple, successive
dispensations of this material. Rinsing is performed between changes of material.
same material.
R inse time
l Minimum: 1 sec
l Maximum: 5 sec
l Default: 1 sec
Enable agitation
When selected, the rinse solution is moved up into the probe and a simulated scrubbing helps clean the inner
probe walls. This is repeated the number of times you select.
l Minimum: 1 second
l Default: 1 second

See Also
l Calibration
l Parallelism
l Rerun Rules

Chapter 4 – Setup
Sample Pre-Dilution
Overview
There are two pre-dilution options:
l Sample pre-dilution – Dilution typically used to run a test
l Alternative pre-dilution – Atypical dilution used to eliminate certain effects
Accessing the Sample Pre-Dilution Screen

To access the Sample pre-dilution screen:
3. In the Test Definition navigational tree, expand Analytical cycle definition and select Sample pre-
dilution.
4. <Optional> Edit the Sample pre-dilution screen.

Sample Pre-Dilution
Sample Pre-dilution screen
Enable sample pre-dilution

Option to activate pre-dilution parameters. Enables the fields on the General, Sample/Mixture and Diluent
tabs.

Chapter 4 – Setup
General Tab
Dilution definition
N umber of parts sample

Specifies the number of parts of sample to use in sample dilutions.
Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts
of diluent are added for every one part of sample. This dilution ratio is 1:10.
N umber of parts diluent

Specifies the number of parts of diluent to use in diluent dilutions.
Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts
of diluent are added for every one part of sample. This dilution ratio is 1:10.
Minimum aspiratable volume

Minimum volume of material used in dilutions. By default, the instrument attempts to use the smallest pos-
sible volume (4 µL) when performing calculations. The value in this field overrides the default volume and
forces the system to use the volume of material specified in this field when preparing dilutions.
l Minimum: 4 μL
l Maximum: 50 μL
l Default: 4 μL
Pre-dilution Table
This read-only table lists the volumes that are used to dilute the sample.
Enable Mix
Option to activate the mix parameters. Enables the fields in this section.
Mix Volume
Percentage of material in the cuvette cell that is aspirated from the cuvette cell and redispensed into the same
cuvette cell to mix the material. The mix volume is calculated as:
l Mix volume = (total cuvette volume - cuvette dead volume) * mix %
l Minimum: 25 μL
l Maximum: 100 μL
l Cuvette dead volume is 65 μL. Cuvette maximum volume is 600 μL.

Sample Pre-Dilution
N umber of C ycles
Number of mix cycles to perform.
l Minimum: 1 cycle
l Maximum: 3 cycles
l Default: 1 cycle
R inse after Mix

Number of seconds to rinse the probe after a mix is performed.
l Minimum: 1 sec
l Maximum: 5 sec
l Default: 1 sec
NOTE: To perform a mix, the cuvette cell must contain a minimum of 100 μL of liquid.

Chapter 4 – Setup
Sample/Mixture Tab
Use this tab to define sample and mixture1 loading parameters.
Volumes
NOTE: The sum of all volumes cannot exceed 250 μL.
H ead volume
Sample volume aspirated to wet the probe before aspirating the sample volume required to run the test. This
volume is not delivered to the cuvette.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 0 μL
A irgap
Volume of air to aspirate immediately before aspirating the sample, separating the sample and rinse. If a head
volume is used, it is the volume of air separating the sample and head volume.
The airgap prevents rinse contamination and ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL
Transport airgap
Volume of air to aspirate after the sample volume. It prevents material loss during probe movement and
ensures accurate volume delivery.
l Minimum: 0 μL
l Maximum: 250 μL
l Default: 15 μL
H ead volume airgap

Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the
head volume is greater than zero. Otherwise this value is zero.
1A dilution that requires a two-step dilution process to achieve the required dilution ratio.

Sample Pre-Dilution
Rinse
Time
l Minimum: 1 sec
l Maximum: 5 sec
l Default: 1 sec

Chapter 4 – Setup
Diluent Tab
Use this tab to define the loading parameters for diluent material. The Head volume, Airgap, Transport air-
gap and Head volume airgap fields on the Diluent tab are identical to those on the Sample/Mixture tab.
Volumes
NOTE: The sum of all volumes cannot exceed 250 μL.
Material
Select an available diluent material in the list. The material must be defined as a Diluent type in the Material
Definition.
H ead volume
Same as sample Head volume, except for diluent material.
A irgap
Same as sample Airgap, except for diluent material.
Transport airgap
Same as sample Transport airgap, except for diluent material.
H ead volume airgap

Same as sample Head volume airgap, except for diluent material.
See Also
l Test Definition

Alternative Pre-Dilution
Overview
Alternative pre-dilution means using a different sample dilution. For example, a D-Dimer HS test may require
a higher dilution ratio to eliminate prozone effects.
An alternative pre-dilution may be ordered for samples where concentration effects may be a known issue.
An alternative pre-dilution may be triggered via a rerun test if the test is so configured. Alternative pre-dilu-
tion must be enabled and defined before it can be used in test reruns. See Rerun Rule Setup.
Accessing the Alternative Pre-dilution Screen

To open the Alternative Pre-dilution screen:
2. Double-click a test in the Test List. Or if you are creating a new user-defined test, select the Add
icon in the toolbar.
3. In the Test Definition navigation tree, expand Analytical cycle definition, and select Alternative pre-
dilution.
4. Edit the Alternative pre-dilution screen.
6. Select the Previous Screen icon in the toolbar to return to the Test List..

Chapter 4 – Setup
Alternative Pre-dilution Screen
Enable alternative pre-dilution

Option to enable an alternative pre-dilution for a test.
Some IL locked tests have alternative pre-dilution enabled and defined.
For user-defined tests, this option allows you to define an additional pre-dilution. When this option is ena-
bled, you can run the pre-diluted test as a separate test.
When a diluted test is ordered either directly or as a rerun, the dilutions settings defined here are used.
U se extended acquisition time

Option to use an extended acquisition time1 (for acquiring data).
Select this option when the alternative pre-dilution requires a more diluted sample than is defined in the
standard reaction or sample pre-dilution parameters.
1The amount of time that optical data is collected by the system. Acquisition Time can be either Standard or
Extended. Standard Acquisition Time is the time spent collecting the required number of data points to deter-
mine the clotting point or reaction rate for the majority of samples. With Extended Acquisition Time, data is
collected for a longer period of time to determine the clotting point for samples which have prolonged clot-
ting times.

D iluted LIS number

The diluted LIS test ID number may be the same as the parent test or it may be unique. When it is the same
as the parent test, validated results are transmitted to the LIS using the parent LIS test ID number and test
name.
When the diluted LIS number is unique, the diluted format of the test may be ordered from the LIS directly,
and runs using the alternative pre-dilution settings. Diluted tests with validated results and unique LIS
numbers are transmitted to the LIS using the diluted LIS number.
When the LIS number is unique, the LIS can directly order a diluted version of the test. Diluted versions can
also be ordered manually, or as a result of reflex or rerun settings.
Test code
Unique test code for the alternative pre-dilution test. The alternative pre-dilution test code is the test code
plus an automatically added one character extension. You can define the one character extension in Global
Definitions.
General Tab
Same as the Sample Pre-Dilution – General tab.
Sample/Mixture Tab
Same as the Sample Pre-Dilution – Sample/Mixture tab.
Diluent Tab
Same as the Sample Pre-Dilution – Diluent tab.
See Also
l Test Definition
l Sample Pre-Dilution

Chapter 4 – Setup
Data Reduction Parameters

Data reduction parameters are configurable for the Primary Wavelength of user-defined tests.
Configuring Data Reduction Parameters for the Primary Wavelength

To configure the data reduction parameters for the Primary Wavelength:
2. In the Test List, double-click a user-defined test, or select the Add icon in the toolbar to create a
new user-defined test.
3. In the Test Definition navigation pane, expand DR Parameters, Primary wavelength.
4. Select an item under Primary wavelength to open the respective screen.
5. Configure parameters on each screen.
Primary Wavelength
The selections under Primary Wavelength in the navigational tree allow you to configure the following pri-
mary wavelength settings:
l Wavelength Definition
l Raw Data Checks
l Normalized Data Checks
l Primary Algorithm
l Secondary Algorithm
NOTE: If you change the data reduction parameters for your user-defined tests such that the ana-
lytical performance of that test is affected, recalculate the calibrations and samples. See Reviewing Test
Results for information on recalculation.
See Also
l Raw Data Checks
l Calibration
l Parallelism

Data Reduction Parameters

l Rerun Rules

Chapter 4 – Setup
Wavelength Definition
Overview
The Wavelength Definition screen is used to setup the Reference and Normalization methods used in Data
Reduction as well as in error and warning reporting.
All data acquired by the Analyzer1 is reported in terms of its initial value multiplied by 1,000,000. To con-
vert the data back to its original value, each raw data point is divided by 1,000,000.
l Raw data value = raw data value from analytical module/1,000,000
All raw data points are adjusted by their corresponding ORU blanking value. The ORU blanking value is
determined through Diagnostics and each ORU unit. Each position in the ORU and each wavelength has its
own value. See Optical Reading Unit.
l Raw data value = <raw data value>/<ORU blank value>
NOTE: If the ORU blank value is less than the raw data value, the resulting raw data value will be
greater than 1.0. This results in negative values if the data is normalized by absorbance.
Accessing the Wavelength definition screen

To access the Wavelength definition screen:
3. In the Test Definition navigational tree, expand DR Parameters > Primary wavelength, and select
Wavelength definition.
4. <Optional> Edit the parameters on the Primary wavelength screen.

Wavelength Definition screen
Primary Wavelength
Read-only value extracted from the Analytical Cycle screen. Data generated at this wavelength is used to cal-
culate results.
Enable Warnings and Enable Errors

Options to issue warning and error messages. Error reporting is enabled by default.
Enable Reference Method

Option to enable curve referencing, which shifts the normalized data curve towards a baseline value of zero
(or near zero). Data curves are referenced so the curves of a particular test have the same starting point (ref-
erence point) across all samples. This feature is useful with algorithms such as the Threshold algorithm (when
searching for an absolute value) and the Endpoint algorithm.
N umber of Seconds
Time interval used to compute the average of the raw data points. This average is subtracted from each raw
data point in the curve, shifting the entire curve closer to zero.
Enable Normalization Method

Option to enable the normalization method, which converts the data values from the optical reading unit into
Intensity or Absorbance values, as selected here. The resulting data is used to generate the normalized curve.

Chapter 4 – Setup
The default method is Absorbance.
A bsorbance
To normalize using absorbance, each data point in the raw data is converted to mAbs using the following for-
mula:
l Value = -log (data) * 1000
Intensity
To normalize using intensity, each data point in the raw data is converted to %Transmittance using the fol-
lowing formula:
l Value = data * 1000
Smoothing
The process of modifying the normalized data curve to reduce the noise and give it a smoother appearance.
This helps identify the true clot point. The normalized curve may be smoothed up to three times using a mov-
ing average method. For each smooth, the limits are 1-20 data points.
Smoothing uses a moving average algorithm where the number of points specified (the degree) on either side
of each point are averaged. The averaged value replaces the specific point. This process continues for all
points in the data curve.
NOTE: When averaging the data points, the original (not the replaced value) is used. The original
data points are the input. The averaged data point is the output.
Example
In the following example, the normalized data is smoothed three times. Each smoothing operation uses 9
points.

In the transition from normalized to Smooth 1, 9 points on either side of a particular point are averaged to
produce the new point value, as represented in Smooth 1.
In the transition from Smooth 1 to Smooth 2, smoothing of the beginning of the data is demonstrated. The
first point is always an exact copy. The second smoothed point is the average of the first three points (one
point on either side of the second point). The third smoothed point is the average of the first five points (two
points on either side of the third point), and so on, until there are enough points to average the specified
number of points. The end of the data curve is processed the same way, as demonstrated in the transition from
Smooth 2 to Smooth 3.
The number of points used for smoothing determines the coarseness of the smoothing action. The greater the
number of points specified, the greater the number of points averaged and the smoother the curve.
NOTE: For sensitive reactions, a large smoothing degree may erase much of the signal change of the
reaction, and may greatly reduce the ability of the data reduction to locate the clot point. Conversely, a
smoothing degree that is too small may not smooth the curve sufficiently so that the clot point can be dis-
tinguished from the noise.
See Also
l Optical Reading Unit

Chapter 4 – Setup
Raw Data Checks
Overview
Use the Raw Data Checks screen to configure the checks to perform on the raw data collected by the Ana-
lytical Module1. The data checks you configure are performed before the data is processed (normalized,
smoothed or referenced) by the instrument.
The settings on the Raw Data Checks screen are locked for all tests defined by Instrumentation Laboratory.
These fields are editable only for user-defined tests.
Raw data – Values and Delta

Raw data values typically range from 0.0 to 1.2. Some data points acquired by the analyzer may be marked
with ORU flags (noise, calculation errors, etc.). These points, and other erroneous data points (those sig-
nificantly different than their surrounding points) may be omitted from the data through the Signal Check.
Data checks identify raw data curves with patterns that do not match expected (or classical) data curves.
NOTE: Many raw data checks use the delta of the curve (signal change across the curve). The delta
of the raw data curve is not always computed as the signal difference between the last point in the curve and
the first point in the curve (as for classic curves). The delta of the data curve is computed as the difference
between the minima and the maxima of the data curve, where the minima and maxima follow a particular
curve sequence. For example, if a data curve starts at a high value, then drops to a smaller value, then goes
back up to a high value, the delta is computed as the difference between the lowest value and the highest
value.
Accessing the Raw Data Checks screen

To access the Raw Data Checks screen:
3. In the Test Definition navigation tree, expand DR Parameters, Primary wavelength and select Raw
data checks.
4. <User-defined test> Configure the data check parameters in the Raw Data Checks screen.

Raw Data Checks
Raw Data Checks screen
The fields on the Raw Data Checks screen are editable only for user-defined tests. They are not editable for
IL-defined tests.
Enable Raw Data Checks

Option to configure one or more data checks to run on the raw data collected by the Analytical Module1.
The data checks are performed on the data before it is processed by the instrument.
Enable First Point Check

Option to perform the first data point check on the first point after the end of the delay period in the raw
data. Compares the value of the first point in the data curve against some percentage of the delta of the data
curve.
The result is flagged or fails when an unacceptable amount of noise is detected at the beginning of the cycle.

Chapter 4 – Setup
Error and W arning thresholds

Maximum percentage of the delta of the data curve allowed before a warning or error is issued.
Example – CE 5050 (Data) Start point out of range
Enable Last Point Check

Option to compare the value of the last point in the data curve against some percentage of the delta of the
data curve.
The result is flagged or fails when the curve drifts at the end of the reaction.
Error and W arning thresholds

Maximum percentage of the delta of the data curve allowed before a warning or error is issued.
Example –CE 5058 (Data) Endpoint range
Enable Signal Check

Option to perform a signal check on all data points in the raw data curve. The signal check performs both of
the following tasks:
l Checks the value of each data point.
l Marks bad data points with ORU flags.

Raw Data Checks
Signal minimum an d Signal maximum

Set the acceptable signal range in these fields. If a data point occurs outside the specified range or is marked
with an ORU flag, it may be replaced with a calculated data point that is within the range and is not marked
with an ORU.
Configure an acceptable number of bad data points for substitution in the Maximum illegal values field.
Maximum illegal values

Maximum number of bad data points to allow for substitution, expressed as a percentage of the total number
of points in the data curve. Configure the percentage in this field. If the number of bad points found in the
data curve exceeds this value (%), the result fails.
Enable Substitution Method

Data point substitution methods to use with signal check, allowing data processing to continue. Options
include:
l Replace with previous value – The preceding data point replaces the one that is outside the expected
range or marked with an ORU flag.
l Extrapolate – A bad data point is replaced with one extrapolated by computing the average value of
the preceding data point and the next valid data point in the raw data curve.
Enable Curve Sequence Check

Option to perform a curve sequence check on all data points in the raw data curve. Determines the sequence
of data points in terms of value, from smaller to larger, or from larger to smaller. Most tests have an
expected curve. This check ensures the data set follows expected behavior. Results that do not follow
expected behavior fail. Options are:
l Min follows max – Data values decrease in value over time.
l Max follows min – Data values increase in value over time.
Example –CE 5057 (Data) Curve min. and max. not in correct sequence

Chapter 4 – Setup
Example –CE 5057 (Data) Curve min. and max. not in correct sequence
Enable Spike Removal

Option to remove data spikes in the raw data curve. Compares the difference between two consecutive data
points to a value computed as a percentage of the delta of the raw data curve specified in the Max. % of
curve delta field. If the difference between the two data points exceeds the maximum difference allowed, the
second point may be replaced with a point within the allowable range.
Configure an acceptable number of bad data points for substitution in the Max. % of illegal points field.
Max. % of curve delta

Maximum allowable percentage of the delta of the raw data curve between consecutive data points. Con-
figure the percentage in this field. If the difference between two consecutive data points exceeds this per-
centage, the second point may be replaced with a point within the allowable range.

Raw Data Checks
Max. % of illegal points

Enable Substitution Method

Data point substitution methods used with spike removal, allowing data processing to continue. Options
include:
l Replace with previous value – The preceding data point replaces the one that is outside the expected
range.
l Extrapolate – A bad data point is replaced with one extrapolated by computing the average value of
the preceding data point and the next valid data point in the raw data curve.
Enable Baseline by Moving SD

Option to truncate noisy data in the baseline area of a reaction curve. A stable baseline of the raw data curve
is established by locating the section of the data curve with the smallest standard deviation (SD) followed by
truncation of all data points that occur before the point in time where the smallest SD was found. This
bypasses noise at the beginning of a data curve (for example, noise caused by mixing reagents or the pres-
ence of a bubble).
Enable percentage of time

Option to use the specified percentage of the reaction curve time to locate the smallest SD calculated as fol-
lows:
l (Total acquisition time – delay) * percentage
Specify the percentage in the Percentage field. The SD calculation begins at the end of the delay time and
continues for the time corresponding to the percentage of time specified.
Enable absolute time

Option to use an absolute amount of time in the reaction curve, specified in the Time field, over which to
locate the smallest SD. The SD calculation begins at the end of the delay time and continues for the specified
time. This option should be selected if Enable baseline by moving SD is selected and the test uses an
extended acquisition mode.
l Minimum = 0.100 seconds
l Maximum = 1800.00 seconds
Siz e of window
Indicates the data points to use (over the specified period of time) to compute the SD. For faster reactions, the
size of the window should be fairly small.

Chapter 4 – Setup
See Also
l Data Flags
l Alarm Messages

Normalized Data Checks
Overview
The Normalized data checks screen allows you to select which normalized data checks you want to perform
and the limits to apply to each of those checks. The normalized data is the data that has been acquired from
the analyzer and is subsequently normalized, then smoothed and finally referenced, providing these data
checks have been enabled.
For many of the normalized data checks, the delta (signal change across the curve) of the normalized data
curve is used. It is important to note that the delta of the normalized data curve is not necessarily computed
as the signal difference between the last point in the curve and the first point in the curve (although for clas-
sic curves, this is the case). The delta of the data curve is computed as the difference between the minima and
the maxima of the data curve, where the minima and maxima follow a particular curve sequence. So, for exam-
ple, if a data curve starts at a high value, then drops to a lower value, then goes back up to a high value, the
delta is computed as the difference between the lowest value and the highest value.
Accessing the Normalized Data Checks Screen

To access the Normalized Data Checks screen:
3. In the Test Definition navigational tree, expand DR Parameters, Primary wavelength and select Nor-
malized data checks.
4. <User-defined tests> Configure the Normalized data checks screen.

Chapter 4 – Setup
Normalized Data Checks screen
Enable Normalized Delta Checks

Check to enable any or all normalized data checks. The normalized data checks are checks that are performed
on the normalized and smoothed data curve.
N ormalized Signal C heck

Aids in choosing the correct derivative peak for algorithms based on derivative methods (first derivative, sec-
ond derivative, and delta). When enabled, derivative peaks found in an area of the normalized curve where
the signal is trending in a negative direction are not considered valid and are ignored.
Enable N ormaliz ed C urve D elta U pper Limit

Determines if the magnitude of the reaction curve is too high. Computes the delta of the normalized data
curve and compares the actual delta value against the allowed delta value. Results obtained from curves
where the delta is greater than the maximum delta expected fail.
When enabled, the following fields are also enabled:
l Error limit (Upper)
l Warning limit (Upper)

Enable N ormaliz ed C urve D elta Lower Limit

Determines if the magnitude of the reaction curve is too low. Computes the delta of the normalized data
curve and compare the actual delta value against the allowed delta value. Results obtained from curves where
the delta is less than the minimum delta expected fail.
If this field is enabled, the following fields are also enabled:
l Error limit (Lower)
l Warning limit (Lower)
Example – CE 5060 (Data) Minima delta not found
Enable C alibrated R esult D elta C heck

Compares the normalized curve delta of a sample to that of the lowest calibrator1 dilution. If the normalized
curve delta of the sample is not within the tolerance range of the lowest calibrator dilution normalized curve
delta, the result is either failed or flagged. This check is only applicable to tests that have a validated cal-
ibration.
Max Tolerance
Defines the allowable variation (%) around the lowest calibrator dilution delta. If this range is violated, the
result is failed.
Max Tolerance warning
Defines the allowable variation (%) around the lowest calibrator dilution delta. If this range is violated, the
result is flagged.

Chapter 4 – Setup
Baseline Check Tab

Enable Baseline Check
Verifies that the baseline (beginning) of the reaction is stable. If the data curve has been referenced, you can
establish an expected mean and tolerance for the baseline of the curve. Regardless of whether the data curve
has been referenced or not, you can establish an expected maximum standard deviation (SD). Not all data
curves have a signature that allows for a stable baseline.
N umber of Seconds
Number of seconds over which the baseline average of the normalized data is computed.
Enable Mean C heck

Verifies that the mean computed for the baseline is within the expected range.
Enable SD C heck
Ensures that the beginning of the data curve is stable. Results obtained from curves that do not meet the SD
check error criterion fail.
Example – CE 5052 (Data) Baseline SD out of range

Endpoint Check Tab
Enable Endpoint Check

Verifies that the end of the reaction curve is stable and is not drifting. If the data curve has been referenced
and the test has predictable curves, you can establish an expected mean and tolerance for the endpoint of the
curve. Regardless of whether the data curve has been referenced or not, you can establish an expected max-
imum standard deviation. Not all data curves have a signature that allows for a stable endpoint.
N umber of Seconds
Number of seconds over which the endpoint average of the normalized data is computed.
Enable Mean C heck

Verifies that the mean computed for the endpoint is within the expected range.
Enable SD C heck
Fails samples that exceed the variation determined during test method development. Ensures that the end of
the data curve is stable. Curves that do not meet the SD check error criterion fail.

Chapter 4 – Setup
Multiple Threshold Check Tab
Enable Multiple Threshold Check

Searches the normalized data, starting at the beginning of the data, for multiple occurrences of a defined
threshold value. Only considers data that is moving in a positive direction. The threshold value is defined as
either an absolute value or a percentage of the normalized curve delta.
Method
If the method is Absolute value of reference curve, the curve must be referenced.
If the method is Percentage of curve, the threshold limit value is calculated as follows:
Threshold Limit Value (Error or Warning) = Curve Minimum + (Curve Delta * Limit
Value/100)

The Multiple Threshold Check can fail or flag samples that present with this type of abnormal curve char-
acteristic.
Error Limit
The Error Limit is calculated using the Threshold Limit Value calculation above where the limit value is the
value defined in the Error Limit field. If the Threshold Limit Error Value is found two times and the time
between each occurrence of the located threshold value is greater than the defined time span, the result fails
with the error, CE 5092 Normalized data contains multiple thresholds.
W arning Limit
The Warning Limit is calculated using the Threshold Limit Value calculation above where the limit value is
the value defined in the Warning Limit field. If the Threshold Limit Warning Value is found twice and the
time between each occurrence of the located threshold value is greater than the defined time span, the result
is reported with the warning: CW 5232 “Normalized data contains multiple thresholds.
NOTE: If the warning limit is set to the same value as the error limit, only the error is generated.
Time Span
Distinguishes between true reaction curve anomalies and baseline noise and is the time between two occur-
rences of the threshold limit value. To produce an error or warning, the time between two occurrences of the
threshold limit value must be greater than the limit defined in the Time Span field; otherwise the two values
are considered noise.
See Also

Chapter 4 – Setup
Primary Algorithm
The primary algorithm used to determine the end point of a reaction.
The settings on the Primary Algorithm screen are locked for all tests defined by Instrumentation Laboratory.
These fields are editable only for user-defined tests.
Accessing Primary Algorithm Parameters

To view the primary algorithm for a test:
3. In the Test Definition navigation pane, expand DR Parameters, Primary wavelength and select
Primary algorithm.
4. <User-defined tests> Configure the primary algorithm parameters in the Primary algorithm screen.
Primary Algorithm Screen
Enable Primary Algorithm

Option to enable the fields on the Primary Algorithm screen.

Primary Algorithm
Endpoint Algorithm
The average of a specified number of data points at the end of the curve is calculated to produce a result in
terms of milliabsorbance or % transmittance.
l indicates region defined by endpoint time (2 sec)

l The red dot indicates average of data points defined by endpoint time
Endpoint time
Time span at the end of the curve over which to compute the average of the normalized data points.
Linear Kinetic Algorithm

The change in optical signal over a given amount of time is calculated. Valid results are %Tran-
smittance/min, Transmittance/min, or Milliabsorbance/min.

Chapter 4 – Setup
Linear Kinetic Algorithm screen
Slope of curve
Option to compute the change in optical signal as the slope of the normalized data curve beginning at the
start time and continuing for the total time indicated by Time. The slope calculation is a simple linear regres-
sion calculation. At the end of the calculation, the computed slope is adjusted for the length of time of the
calculation and for the rate at which the data was acquired.
Start time
Point in time in the reaction data where computing the slope begins.
Time
Total amount of time used to calculate the slope.
Delta of curve
The difference between the reaction signal at the specified starting time and that at the specified end time is
calculated. At the conclusion of the calculation, the computed delta is adjusted for the length of time of the
calculation and for the rate at which the data was acquired.

Primary Algorithm
Method
Select the method used to calculate the change in optical signal over a given amount of time. Options are:
l Baseline/Endpoint averages – The instrument calculates the averages of the data over the specified
baseline and endpoint times, then calculates the difference.
l Exact start/end Time – The system calculates the difference between the data values of a point at the
specified start time and end time.
Start time
Enabled only when the method is Exact start/end time. The start time is the point in time in the reaction data
to begin computing the slope of the normalized data.
End time
Editable only when the method is Exact start/end time. Time is the total amount of time over which to cal-
culate the slope.
Baseline time
Editable only when the method is Baseline/Endpoint averages. Baseline time is the amount of time at the
beginning of the curve over which to compute the average of the normalized data points.
Endpoint time
Editable only when the method is Baseline/Endpoint averages. Endpoint time is the amount of time at the
end of the curve over which to compute the average of the normalized data points.

Chapter 4 – Setup
Example – 5060 CE (Data) Minima delta not found:
Enable linear regression SD error check

Verifies whether the standard deviation of the calculated slope is less than the specified error limit. If greater
than the error limit, the result fails.
SD error limit
Maximum standard deviation allowed before the data is considered to be in error.
Enable linear regression SD warning check

Verifies whether the standard deviation of the slope is less than the specified warning limit. If greater than
the warning limit, the result returns with a warning flag.
SD warning limit
Maximum standard deviation allowed before a warning flag is associated with the result.

Primary Algorithm
Example – 5066 CE (Reaction) Linear Regression SD out of range:
Enable negative calculation

When selected, difference calculations within the slope or delta methods are not computed using the absolute
value. As a result, negative measured values may be produced. If enabled, the initial slope check is also cal-
culated without considering absolute values. If disabled, the absolute value is used for difference calculations
within the slope or delta methods as well as in the initial slope check computation.
Enable initial slope check

When enabled, the slope of the normalized data is calculated starting at the beginning of the data curve, after
the end of any delay period and for the total time as indicated by the parameter Time. The initial slope cal-
culation is a simple linear regression. At the conclusion of the calculation, the computed slope is adjusted for
the length of time of the calculation and for the rate at which the data was acquired.
Time
Amount of time used to calculate the initial slope. The valid range is 0.0 seconds to the standard acquisition
time.
Maximum Error Limit

If the computed initial slope is greater than the maximum error limit, all processing ceases and the result fails.
The valid range is 0.0 to the maximum displayable value.
Maximum W arning Limit

If the computed initial slope is less than the maximum error limit but greater than the warning limit, proc-
essing continues, but the result is flagged. Valid range is 0.0 to the maximum displayable value.

Chapter 4 – Setup
Example – 5076 CE (Reaction) Initial slope error:
Threshold Algorithm
Determines the measured result by locating a threshold limit value within the data curve. The limit value
may be determined as a percentage of the delta of the normalized data curve, or it may be an absolute value
within the data curve. If the limit value to search for is an absolute value, the data curve must first be ref-
erenced.
When locating values in the data curve as a percentage of the data curve, the threshold limit value (and
check value, if enabled) is always be located (because the computed value is guaranteed to be within the
delta of the data curve).

Primary Algorithm
Method
The following methods can be used to compute (or assign) the value located in the data curve.
l Percentage of curve – The system calculates the threshold search value using the following rela-
tionship:
o Threshold value = Normalized curve baseline + ((Normalized curve
maximum – Normalized curve baseline) * Limit value)
l Absolute value of referenced curve – The system tries to locate the point with the value closest to
this value. Reference must be enabled if searching for absolute values. See Enable reference method.
Search Direction
The following search directions can be used to move through the curve when locating the threshold value.
l Forward – Starts searching at the beginning of the reaction curve when trying to locate the threshold
value. Stops searching at the last instance of the sought-after value.
l Backward – Starts searching at the end of the reaction curve when trying to locate the threshold
value. Stops searching at the first instance of the sought-after value.
Limit Value
Value to search in the data curve. The value depends upon the method.

Chapter 4 – Setup
l If method is Percentage of curve, enter a value in terms of percent ranging from 0-100%.
l If method is Absolute value of referenced curve, enter an absolute value ranging from 0 to the max-
imum displayable value.
Enable Threshold Check

Option for the threshold algorithm to search the data curve for an additional value. Ensures the data curve
has enough magnitude (if using absolute values); or ensures the reaction has occurred in an expected amount
of time for the test.
C heck Value
Additional value to locate in the data curve.
l If method is Percentage of curve, enter a value in terms of percent ranging from 0-100%.
l If method is Absolute value of referenced curve, enter an absolute value ranging from 0 to the max-
imum displayable value.
Enable Threshold C heck Error

Option to flag the data with an error when the threshold check value is not found in the data curve. It is
impossible to get this error if the threshold method is Percentage of the curve.
Enable Time Span C heck

Option to calculate the difference in time between the location of the threshold value and the threshold
check value and generate a warning or an error if the difference is outside the specified range.
Method
l Greater than – An error is generated when the time at which the limit and check values are located is
greater than the specified error limit.
l Less than – An error is generated when the time between the time at which the limit and check
values are located is less than the specified error limit.
Error Limit
Difference in time between thresholds used to generate an error.
W arning Limit
Difference in time between thresholds used to generate a warning.
Example
In the example below, the data curve has not been referenced. The red line indicates the time when the thresh-
old limit value was located. The green line indicates the time when the threshold check value was located.
The time span is the time (8 seconds) between when the limit value was found (31 seconds) and the check
value was found (39 seconds).
The measured result is the time when the limit value was found in the data curve.

Primary Algorithm
First and Second Derivative Algorithms

First Derivative
The first derivative algorithm locates the clotting time by finding the point of maximum inflection in the nor-
malized curve.

Chapter 4 – Setup
Second Derivative
The second derivative algorithm locates the clotting time by finding the point of maximum inflection in the
second derivative curve.

Primary Algorithm
Method
l Slope – (1st and 2nd Derivative) Uses specified points to calculate the slope using a linear model.
l Points – (1st and 2nd Derivative) Number of data points to the left and right of each data point used
to calculate the first and/or second derivative.
Peak Search Method (1st and 2nd D erivative)

l Greatest maxima peak – (1st and 2nd Derivative) Searches the derivative curve for the peak with the
greatest positive value. The peak maxima must be greater than the value established by the Maxima
Peak Check, if enabled. If not enabled, the value must be greater than zero to be recognized as a peak.
A maximum of one peak is located.
l Last maxima peak – (1st and 2nd Derivative) Searches the derivative curve for all peaks that satisfy
the maxima peak criteria. The peak maxima must be greater than the value established by the Maxima
Peak Check, if enabled. If not enabled, the value must be greater than zero to be recognized as a peak.
The first point in the data curve cannot be considered a maxima peak, nor can the time of a maxima
peak be after what is considered the end of the curve (maximum value of absorbance-normalized
curve). A maximum of 100 peaks are located. The last maxima peak found is used for calculating
results, if it passes all peak check criteria. If the last max peak fails the peak check criteria, the next to
last peak is used, and so on, until a result is determined, or until the list of peaks is exhausted.

Chapter 4 – Setup
l Greatest Max/Min Couplet – (2nd Derivative) A minima peak (<0) must immediately follow the max-
ima peak. For this reason, this check can only be used with second derivative curves. The peak max-
ima must be greater than the value established by the Maxima Peak Check value and the absolute
value of the peak minima must be greater than the Minima Peak Check value, if enabled. The first
point in the data curve cannot be considered a maxima peak, nor can the time of a maxima or minima
peak be after what is considered the end of the curve (maximum value of absorbance-normalized
curve). A maximum of 100 couplets are located. The couplet with the greatest signal difference
between the minima and the maxima is considered first. If this couplet fails the peak check criteria,
the couplet with the next greatest difference between minima and maxima is used, and so on, until a
valid couplet is found or the list of peaks is exhausted.
l Last Max/Min Couplet – (2nd Derivative) A minima peak (<0) must immediately follow the maxima
peak. For this reason, this check can only be used with second derivative curves. The peak maxima
must be greater than the value established by the Maxima Peak Check value and the absolute value of
the peak minima must be greater than the Minima Peak Check value, if enabled. The first point in the
data curve cannot be considered a maxima peak, nor can the time of a maxima or minima peak be
after what is considered the end of the curve (maximum value of absorbance-normalized curve). A
maximum of 100 couplets are located. The last couplet located is considered first. If this couplet fails
the peak check criteria, the couplet with the next greatest difference between minima and maxima is
used, and so on, until a valid couplet is found or the list of peaks is exhausted.
l Greatest Max/Min to Zero Couplet – (2nd Derivative) This search method is identical to the Great-
est Max/Min Couplet with the following exception:
o After the couplet is located, the search continues through the 2nd derivative minima to find
the first point greater than zero.
l Last Max/Min to Zero Couplet – (2nd Derivative) This search method is identical to the Last
Max/Min Couplet with the following exception:
o After the couplet is located, the search continues through the 2nd derivative minima to find
the first point greater than zero.
Smoothing (1st and 2nd D erivative)

Process of adjusting data points to remove noise artifacts. Select the best option. Up to three smoothes can be
applied to each derivative function.
Delta Checks
Max. Peak D elta C heck (1st and 2nd D erivative)

l Calculates the delta of the normalized data at the location within the normalized data for each max-
ima peak found in the derivative data. This is computed by taking the difference of the value of the
point in the normalized data at the time indicated by the maxima peak value and the point in the nor-
malized data at the time that is considered the baseline of the curve.
l Verifies the calculated delta is greater than the user-specified absolute value.

Primary Algorithm
Max. Peak D elta % C heck (1st and 2nd D erivative)

ima peak found in the derivative data. This is computed by taking the difference of the value of the
point in the normalized data at the time indicated by the maxima peak maximum value and the point
in the normalized data at the time that is considered the baseline of the curve.
l Verifies the calculated delta is greater than the user-specified percentage of the delta of the normalized
curve.
D erivative Max. Type (1st derivative)

Enable one of the following:
l Max to the normalized endpoint – The first derivative maximum is computed by calculating the dif-
ference between the first derivative signal maxima and the first derivative signal corresponding to the
time of the normalized curve endpoint.
l Max to the normalized baseline – The first derivative maximum is computed by calculating the dif-
ference between the first derivative signal maxima and the first derivative signal corresponding to the
time of the normalized curve baseline.
Peak D elta C heck (2nd D erivative)

ima/minima peak found in the derivative data. This is computed by taking the difference between the
value of the point in the normalized data at the time indicated by the maxima peak value and the
minima peak value.
l Verifies the calculated delta is greater than the user-specified absolute value.

Chapter 4 – Setup
Peak D elta % C heck (2nd D erivative)

ima peak found in the derivative data. This is computed by taking the difference between the value
of the point in the normalized data at the time indicated by the maxima peak maximum value and
the minima peak minimum value.
l Verifies that the calculated delta is greater than the user-specified percentage of the delta of the nor-
malized curve.
For the data shown above, assume the following warning and error limits are set:

Primary Algorithm
l Peak Delta Check Warning: 8 mAbs

l Peak Delta Check Error: 4 mAbs
l Peak Delta % Check Warning: 40%
l Peak Delta % Check Error: 20%
NOTE: In this example:

l The Total Curve Δ is 21.8 mAbs.
l ΔMax2 - Min 2 = 11.6 mAbs (indicated by Xs on normalized curve) or 53.2% of curve
l ΔMax 1 - Min 1 = 1 mAbs (indicated by an X with a vertical line through it on normalized curve) or
4.5% of curve
In the example above, all search methods would use the peak checks as follows:
l ΔMax 1- Min 1 is less than the Peak Delta Warning and Error
l ΔMax 2- Min 2 is greater than the Peak Delta Warning
l ΔMax 1- Min 1 is less than the Peak Delta % Warning and Error
l ΔMax 2- Min 2 is greater than the Peak Delta % Warning
Depending on the search method, Max 2 or couplet 2 would be used to calculate the result.

Chapter 4 – Setup
Peak Checks
Peak checks are used to help identify the correct peaks. If a peak or couplet passes the peak check criteria
(warning and error) a result returns. If a peak or couplet exceeds the warning limit but not the error limit, a
result returns with a warning. If a peak or couplet exceeds the error limit, the result returns as failed.
Peak checks may be useful in removing 2nd derivative maxima and minima which are the result of rises in
the baseline or bumps in the clot curve after the clotting has slowed.
Max. Peak C heck (1st and 2nd D erivative)

Verifies the maxima peak occurs earlier than the last valid point in the derivative curve.
Verifies the value of the maxima peak is greater than the user-specified warning/error limits established for
the maxima peak.
Min. Peak C heck (2nd D erivative only)

Verifies the minima peak occurs earlier than the last valid point in the derivative curve.
Verifies the absolute value of the minima peak is greater than the user-specified warning/error limits estab-
lished for the minima peak.

Primary Algorithm
Enable 1st D erivative B ound C heck (2nd D erivative only)

Ensures the second derivative maxima peak selected occurs before the first derivative maxima peak. If the
peak search method used is a couplet method, it ensures the minima peak selected occurs after the first deriv-
ative maxima peak.
For example:
If the Peak Search Method is:

Greatest Max Peak
l Max1 is less than Max Peak Check warning limit, but is considered.
l Max2 is greater than Max Peak Check warning limit and is considered.
l Max3 is greater than Max Peak Check warning limit and is considered.
l Max2 is chosen to calculate result as Max2 is greater than Max3.
If Max1 was the only Max to be found, the system would return a result using this peak with a warning
(Maxima of 2nd derivative is low).
Greatest Max/Min Couplet
l Max/Min1 does not meet Max (warning) or Min (error) Peak Check criteria and is not considered.
l Max/Min2 meets all Peak Check criteria and is considered.

Chapter 4 – Setup
l Max/Min2 is used to calculate result as this couplet has the largest difference between the max and
min of all the couplets that were considered.
l If Min1 and Max1 were the only min/max pair to be found, the system would return an error
(min/max peak criteria not met).
Last Max Peak
l Max1 does not meet Max Peak warning limit, but is considered.
l Max2 meets Max Peak Check criteria and is considered.
l Max3 meets Max Peak Check criteria and is considered.
l Max3 is the last max found which meets criteria and is used to calculate result.
l If Max1 were the only max to be found, the system would return a warning (Maxima of 2nd deriv-
ative is low).
Last Max/Min Couplet
l Max/Min1 does not meet Max (warning) or Min (error) Peak Check criteria and is not considered.
l Max/Min3 is used to calculate result as it is the last couplet found which passes all criteria.
l If Min1 and Max1 were the only couplet to be found, the system would return an error (Min/Max
peak criteria not met).
Peak C ount C heck (1st and 2nd derivatives)

This check counts the number of maxima peaks (either as a maxima alone or as part of a peak couplet) within
the specified window size. Starting at the first maxima peak, the window size is determined by adding the
time corresponding to the maxima peak to the window size value. The number of maxima peaks are counted,
and if the number exceeds the number allowed (error or warning limits), the result is flagged (warning) or
failed (error) with an error ERR MAX PEAK COUNT EXCEEDED.
First Peak B oundary (1st and 2nd D erivative)

Check used to distinguish a true peak from noise at the beginning of the data curve. The ascent value is the
increase in intensity of the peak after the first data point. If the curve does not ascend to the defined limit (cal-
culated as Percent Limit x Max Peak Delta) the peak is not considered a valid peak.
D efinition B oundary (1st and 2nd D erivative)

When the Definition Boundary (percent) check is enabled, data reduction uses the maximum value of all the
data within this peak as the peak maxima. You can choose the following three options to determine which of
the local maxima peaks are selected:
l First peak
l Greatest peak
l Last peak

Primary Algorithm
Post Processing Checks (Second Derivative)
Time Span
Compares the difference in time between the minima and maxima peak when a couplet peak search method is
used. Depending on the chosen method, if the difference in time is less than or greater than the error limit,
the result is FAILED. Depending on the chosen method, if the difference in time is less than or greater than
the warning limit, a numeric result with a warning is generated. See: Data Flags, CE 5064.
Delta Algorithm
Uses the 2nd derivative algorithm. The 2nd derivative minima and maxima are located. The time when these
points occur is referenced back to the normalized curve. The difference between the values of the normalized
curve at these times is computed to obtain the delta value.
The above below shows how the delta is computed when the peak search method is either Greatest Max/Min
to Zero Couplet or Last Max/Min to Zero Couplet. The location of the first point in the 2nd derivative curve
that is greater than zero (after it has gone through the minima) is used.

Chapter 4 – Setup
If the Greatest Max/Min Couplet or Last Max/Min Couplet method is used, the minimum of the 2nd deriv-
ative references back to the normalized curve.

Primary Algorithm
Delta Second Derivative Tab
The Delta algorithm setup is similar to the Second Derivative algorithm setup with the following exception:
l Because the Delta Algorithm must use a couplet peak search method, the Last Maxima Peak peak and
Greatest Maxima Peak methods are not available as peak search options.

Chapter 4 – Setup
Final Minus Initial Algorithm
The Final Minus Initial Algorithm calculates a measured result using one of the following methods:
l Computes the difference between two points (Exact start/end time).
l Computes the difference of the averages of several points obtained at the beginning and end of the
curve (Baseline/Endpoint averages).
Method
Select one of the following options in the drop-down list:
l Baseline/Endpoint averages – The system calculates the averages of the data over the specified base-
line and endpoint times, and calculates the difference.
l Baseline Time – Length of time over which to compute the average of the normalized data, starting
from the beginning of the curve. Editable only if the method is Baseline/Endpoint averages.
l Endpoint Time – Length of time at the end of the curve over which to compute the average. Editable
only if the method is Baseline/Endpoint averages.

Primary Algorithm
indicates region defined by Baseline/Endpoint time
Red dots indicate average of data points defined by Baseline/Endpoint time
l Exact Start/End Time – If selected, the system calculates the difference between the data values cor-
responding to the exact points specified in Start time and End time.
l Start Time – This is only editable if the method is Exact Start/End time. This is the point in time in
the reaction to begin computing the slope of the normalized data.
l End Time – This is only editable if the method is Exact Start/End time. This is the total amount of
time used to calculate the slope of the normalized data.

Chapter 4 – Setup
Enable Linear Regression SD Error Check

Option to verify that the standard deviation of the slope is less than the specified error limit. A value greater
than the warning limit returns a FAILED result.
l SD Error Limit – Maximum standard deviation allowed before the data is considered in error.
Enable Linear Regression SD Warning Check

Option to verify that the standard deviation of the slope is less than the specified warning limit. A value
greater than the error limit returns a result with a warning flag.
l SD Warning Limit – Maximum standard deviation allowed before results are flagged with a warning.
Enable Negative Calculation

With the negative calculation option enabled, the Final minus initial algorithm is no longer computed using
the absolute value of the difference. As a result, negative measured values may be produced. If it is enabled,
the Initial slope check is also calculated without considering absolute values. If disabled, the absolute value
is used for the difference calculation within the final minus initial algorithm, as well as in the initial slope
check computation.
Enable Initial Slope Check

The slope of the normalized data is calculated starting at the beginning of the data curve (after the end of any
delay period) and for the total time indicated by the Time parameter. The initial slope calculation is a simple
linear regression. After the slope is calculated, it is adjusted for the length of time of the calculation and for
the rate at which the data was acquired.
Time
Total amount of time used to calculate the initial slope. The valid range is 0 seconds to the standard acqui-
sition time.
Maximum Error Limit

If the computed initial slope is greater than the maximum error limit, all processing ceases, and the result
fails. The valid range is 0 to the maximum displayable value.
Maximum W arning Limit

If the computed initial slope is less than the maximum error limit but greater than the warning limit, proc-
essing continues, but the result is flagged. The valid range is 0 to the maximum displayable value.

Primary Algorithm
Statistics Algorithm
The Statistics algorithm performs a linear regression calculation on the range of data between the statistics
start time and statistics time values. It calculates the mean of the linear regression data.
Statistics
Statistics Start Time

Time in the data to begin performing calculations.
Statistics Time
Total amount of time over which to perform calculations.
Enable Optical Interference Check

Option to apply error and warning checks to the data.

Chapter 4 – Setup
Error Limit an d Tolerance

Parameters used to define the range of acceptable mean values. An error message is generated when the limit
is exceeded.
ER ange
Range of acceptable mean values computed using the error limit and tolerance values.
W arning Limit an d Tolerance

Parameters used to define the range of acceptable mean values. A warning flag associated with the sample
when the limit is exceeded.
W R ange
Range of acceptable mean values computed using the warning limit and tolerance values.
See Also
l Clot Curve Analysis

Secondary Algorithm
Secondary Algorithm
The system uses the secondary algorithm if the primary algorithm fails any of its curve checks.
NOTE:
l The secondary algorithm must be enabled by clicking the Enable range for secondary algorithm
option in Calibration Setup.
l The secondary algorithm must use the same measured result unit (for example, seconds) as the primary
algorithm.
If any of the raw data checks or normalized data checks fail, neither the primary algorithm nor the secondary
algorithm is used, and an error results.
The secondary algorithm options are similar to those of the primary algorithm.
See Also

Chapter 4 – Setup
Result Unit Definition

Use the Result Unit Definition screen to define sample result units and select them for sample result display.
Accessing the Result Unit Definition screen

To open the Result Unit Definition screen:
3. In the Test Definition navigation tree, select Result units.
Viewing and Editing Measured Units

To view or edit a measured unit:
1. Open the Result Unit Definition screen.
2. Place focus1 on a unit of measurement in the Unit column.
3. Select the View icon in the toolbar.

4. Configure editable fields in the Result Unit Definition dialog box.
5. Select OK to close the window.
NOTE:
l A test must always have a measured unit defined. The default measured unit is seconds.
l The measured result unit and ranges of the test that imports results calibration data from another test
must be the same as the measured result unit and ranges of the imported test.

Adding Result Units

To add a result unit:
2. Select the Add icon in the toolbar to open the Non-IL Result Unit Definition window.
3. Configure the new result unit in the Non-IL Result Unit Definition window.
4. Select OK to close the window.
NOTE: If the measured result is 0, the Ratio and INR results fail.
Deleting a Result Unit

To delete a result unit:
2. Select1 the result unit in the table to delete.
3. Select the Delete icon and confirm.
NOTE: Measured result units cannot be deleted.
one object.

Chapter 4 – Setup
From this screen you can do the following:

l Add a result unit.
l View result unit details.
l Delete a result unit.
Result Unit Definition Columns
Selection C olumn
U nit
The unit that is measured in the test.
U nit Type
The type of unit measured in the test. Available unit types are Measured, Calibrated, Calculated, Paired, and
Statistical.
Label
Abbreviated form of the unit. Indicates how the unit appears in the sample list.
A check mark indicates the material is an IL-defined material.

dec.
Number of decimal places the reported result contains.
N ormal, Therapeutic, Linear a n d Test R ange

Normal, Therapeutic, Linear and Test Range columns display the established minimum and maximum values
for each of these ranges.
Patient Result Selection

Select up to four predefined result unit types per sample to display in the Sample List.
Primary Unit Configuration
Primary U nit
Select the predefined result unit used to check the maximum difference between replicate results.
NOTE: You should define only one primary calibrated unit.
Enable Max D ifference

If this option is enabled, and the number of replicates is 2, the maximum difference between each of the rep-
licates is computed. If the percent difference between either of the results and the mean of the results is
greater than the maximum difference allowed, the mean of the result is flagged with a warning.
Max D ifference
Specifies the maximum difference between an individual result and the mean result as a percentage that can-
not be exceeded or the mean result is flagged as an error or warning.
Measured Result Curve Display Settings

Use these fields to configure the graphical display settings for the measured result curve.

Chapter 4 – Setup
Result Unit Definition Screen
Unit selection
U nit type
Select one of the following result unit types:
l Calculated – Some tests require more than one result or the use of a conversion factor to compute a
result. An example of such a test is the Prothrombin Time test, where an ISI value is required to com-
pute the INR result. The following choices are available for calculated units:
o Ratio
o INR
If the measured result is 0, the Ratio and INR results fail.
l Calibrated – If a test requires calibration, it must always have a calibrated unit defined to report a cal-
ibrated result.
NOTE: You should define one primary calibrated unit (one unit with no conversion).
The following choices are available for calibrated units:

o %
o g/L
o mg/L
o μg/L
o μg/mL
o mg/dL
o ng/mL
o U/mL
o IU/dL
o IU/mL
o mU/mL
o AU/mL
o μmol/L
o nmol/L
o user-defined
l Statistical – A statistical unit is required when the statistic algorithm is chosen as the primary algo-
rithm. The choices available for statistical units are:
o %CV
o SD
o Slope
l Paired – Tests that are configured as paired tests require the use of a paired unit. An example of such
a test is the APCR test, where results from both the activated and non-activated forms of the test are
required to compute a Ratio result. The following choices are available for paired units:
o PiCI%: Calculated as ((ThPB - ThPA)/ThPB )*100=PiCi%
o Test Ratio: calculated as (S1/S2)
o Test Ratio-N%: calculated as ((S1-S2)/(NPP1-NPP2)) * 100
o Test Ratio-N: calculated as ((S1/S2)/(NPP1/NPP2))
o Test Delta: calculated as (S1-S2)
o Test Delta %: calculated as ((S1-S2)/S1) * 100
o Test Delta-N: calculated as ((S1-S2)/(NPP1 – NPP2))
o Test Delta-N%: calculated as ((S1/S2)/(NPP1/NPP2)) * 100.
U nit
Select the unit specific to the unit type.
D ecimals
Select the number of decimal places to be reported for the result.

Chapter 4 – Setup
Calibrated unit data

This is editable only if the selected unit type is calibrated.
Enable conversion
Option to enable conversion.
C onversion factor
Linear multiplication factor applied to the result unit for converting results (e.g. from g/L to mg/dL).
U ser-defined label
The user-defined label allows you to input the user-defined calibration unit. It is used when you want to
define your own calibrated unit. You can create one user-defined unit per test.
Enable transform negative results to z ero

This option is available only for calibrated units.
Option to define a limit for acceptable negative calibrated values. If a negative calibrated result is obtained
with a value that is less than zero but more positive than the negative value limit, the result is reported as
zero. If a negative calibrated result is obtained with a value that is less than zero and more negative than the
negative value limit, the result fails.
NOTE: Calibration results are automatically reported as 0 in the following situations:

l When measured result values (any sample type) are less than the mean of the measured result of the
0% calibration dilution for assays employing a 0% dilution that have a positive calibration slope; or
l When measured result values (any sample type) are greater than the mean of the measured result of the
0% calibration dilution for assays employing a 0% dilution that have a negative calibration slope.
N egative value limit

The negative limit below which the result fails.
Paired result data

This is editable only if the selected unit type is paired.
Paired unit
Tests that are configured as paired tests require the use of a paired unit. An example of such a test is the
APCR test, where results from both the activated and non-activated form of the test are required to compute a
ratio result.
INR unit data

Read-only information extracted from the material definition. It displays material to which the ISI value is
specific, as well as the ISI value itself, provided that the unit type is calculated and the unit is INR.

Allow negative results

Option to enter a limit for acceptable negative values. If a negative result is obtained and the value is less
than zero but more positive than the negative value limit, the value is reported as a true negative value. If a
negative result is obtained that is less than zero and more negative than the negative value limit, the value
fails. Ror Linear Kinetic and Final minus initial algorithms, negative values for measured results are only
reported if negative calculation is enabled from within the Primary algorithm setup for these algorithms and
Allow negative results is enabled for the measured result unit.
This field is available for the following units:
l Measured result unit
l Paired units
l Calculated unit
l Statistical result unit
Enable result correlation

When this option is enabled and the result is found to be within the specified correlation range, a correlation
factor and offset are applied to the result to obtain better agreement with results obtained by another method.
The result correlation default is disabled.
Result Correlation Formula
y = a*x + b
Where:
y = Calculated new result
x = Original result
a = Factor
b = Offset
NOTE: In a linear regression, results from the ACL TOP are the x set of values.
Correlation Range
C orrelation range Minimum a n d Maximum

Range in which the result must fall in order to apply correlation factor and offset.
Method
Specifies the use of the linear method when applying factor and offset.
Factor
Value to multiply by each result to shift the slope of the curve. The default value is 1.000.

Chapter 4 – Setup
Offset
Value to add to each result to shift the curve on the y-axis. The offset value is applied before the factor value
is applied. The default value is 0.000.
Ranges
Enable normal range

Option to flag results that fall outside the established limits.
l Minimum/Maximum – Enter minimum and maximum values to define the normal range for the test.
NOTE: For calibrated results employing a conversion factor, the normal range minimum and
maximum values are automatically calculated from the range of the primary calibrated unit and the
conversion factor.
Enable therapeutic range

l Minimum/Maximum – Enter minimum and maximum values to define the therapeutic range for the
test.
Enable linear range

l Minimum/Maximum – Enter minimum and maximum values to define the linear range for the test.
l Extended Time Minimum and Maximum – Enter minimum and maximum values to define the linear
range for the result unit when extended acquisition analysis is performed.
l Alternative Pre-dilution Minimum and Maximum – Enter minimum and maximum values to define
the linear range for the result unit when alternative pre-dilution is performed.
NOTE: For calibrated results employing a conversion factor, all linear range minimum and
maximum values are automatically calculated from the range of the primary calibrated unit and the
conversion factor.
Enable test range

l Minimum/Maximum – Enter minimum and maximum values to define the test range for the result
unit.
l Extended time/alternative pre-dilution – Enter minimum and maximum values to define the test
range for the result unit when extended acquisition analysis is performed.

NOTE: For calibrated results employing a conversion factor, all test range minimum and max-
imum values are automatically calculated from the range of the primary calibrated unit and the con-
version factor.
See Also
l Calibration
l Parallelism
l Rerun Rules

Chapter 4 – Setup
Calibration Setup
Overview
You can define the following calibration items:
l Calibration method, dilution volumes and pipetting parameters for calibrator1 and diluent materials
used to prepare automatic dilutions
l Calibrator materials used in manual calibrations
l Calibration frequency tests
l Data reduction parameters for the calibration math model and related checks.
Calibration can be defined using automatic dilution or pre-diluted calibrators.
Accessing the Calibration Definition screen

To access the Calibration Definition screen:
3. Select Calibration in the Test Definition navigational tree.
4. Click the General, Frequency and DR Parameters tabs to access the respective calibration fields.
5. <Optional> Perform edits in the calibration fields.
Accessing the Automatic Dilution screen

To access the Automatic Dilution screen:
3. In the Test Definition navigation tree, expand Calibration and select Automatic Dilution.
4. <Optional> Perform edits in the General, Calibrator and Diluent tabs.

Calibration Setup
Accessing the Pre-diluted Calibrators screen

To access the Pre-diluted Calibrators screen:
3. In the Test Definition navigation tree, expand Calibration and select Pre-diluted calibrators.
4. <Optional> Edit the calibration points.
See Pre-diluted Calibrators Screen.

Chapter 4 – Setup
Calibration Definition Screen
Enable calibration
Option to activate calibration parameters for editing.

Calibration Setup
General Tab
General
N umber of R eplicates
Number of repeat measurements to perform on each dilution.
l Minimum: 1
l Maximum: 6
l Default: 3
C alibration U nit
Select the unit from the drop down list. Only a primary calibration unit may be selected. A primary cal-
ibration unit is a calibrated unit that does not employ a conversion factor.
C alibration Mode
You can enable Automatic dilutions process or Prediluted calibrators. These are not selectable if import cal-
ibration is enabled.
Enable Import Calibration

Option to import calibration data from another test to calculate calibrated results. If Imported type field is set
to Results Data, the Imported unit field will match the calibration unit from the imported test.
If Imported type is set to Raw Data, the Imported unit field is blank.
Calibration data reduction fields from the imported test are automatically copied into the calibration data
reduction fields of the test that is importing the calibration.
If a test uses an imported calibration, the validated imported calibration must use the same validated cal-
ibration as the master test. If it does not, the calibrated results of the test using the imported calibration are
flagged. If the master calibration is not validated or no longer exists, calibration results of the test using the
imported calibration are flagged.
Imported Test
From this list, select a test from which to import calibration data.
Imported Type
Select one of the following:
l Raw Data – Data as it is acquired from the analyzer.
l Results Data – Values such as the slope, intercept and r2 values calculated for the calibration that is
being imported. When you import results data, the calibration is automatically validated. However, if
you import an unvalidated master calibration, the calibration in the importing test is unvalidated.
Selecting this option enables the Correction Factor field.

Chapter 4 – Setup
C orrection Factor
Multiplier applied to an imported calibration when the Enable Import Calibration option is enabled and the
Imported Type is set to Results Data. This option is only available for copied (open) tests.
This field is disabled for IL tests.
Imported U nit
This displays the calibration unit to import from the calibration.
NOTE:
l If a test imports the raw calibration data from another test, you can configure the delay time for the
importing test.
l The intermediate and start reagents of a test that imports the raw calibration data from another test
must be the same as the intermediate and start reagents of the test that is imported.
l If a test imports the results calibration data from another test, the measured result unit and all result
unit ranges of the test that imports the results calibration data from another test are automatically set
to the same as defined for the measured result unit and ranges of the test that is imported.
Test Feasibility
Test not feasible when no validated calibration

Option to make a test not feasible when there is no validated calibration for that test and the on-board lot of
reagent it uses. This condition is reflected in the Test Feasibility screen and applies to patient tests and asso-
ciated QC tests.
NOTE: When creating an open test that uses a calibration that is imported from another test, the cal-
ibration for the imported test must be performed after the new test definition has been created in order to
obtain calibrated results. The same applies if an existing open test definition is modified to use an imported
calibration.
Calibration Execution
Force mode with reduced clean

Option to force a selected test to calibrate without running any other jobs. When this option is selected, you
may not perform any other operation other than calibrating the selected test. This feature is locked for all
IL tests. This option decreases calibration time for assays that require extra rinsing between dispensing rea-
gents. As a batched calibration, extra rinsing is not required between changes of reagent because no reagent
changes are required.

Calibration Setup
Frequency Tab
Use this screen to define the calibration frequency.
Enable Frequency
Option to define the frequency parameters and to display a warning when calibration is due.
Frequency
Option (in number of hours or days) between calibrations.
NOTE: Only patient jobs are considered when counting the frequency by tests. QC jobs, calibration
points, and NPP points are excluded.
Enable W arning Threshold

Option to configure a warning to issue when calibration is due.
Warning Threshold
Establishes the time to notify you that a calibration is due. If the frequency is set to tests, the warning thresh-
old must be in terms of tests. Likewise, if the frequency is set to hours, the warning threshold must be in
terms of hours. If the frequency is in terms of days, select the warning threshold in terms of hours or days.

Chapter 4 – Setup
DR Parameters Tab
Enable Extrapolation
Option to specify to what extent extrapolation of the calibration curve is allowed. The result unit for these
limits is the same as that specified for the calibration unit on the General tab. Calibration results outside
these limits fail, but the measured result is reported. (The error codes are 5508 for Out of calibration range
high, and 5509 for Out of calibration range low.)
NOTE: The out of calibration range high and low checks are done before the result is multiplied by
the pre-dilution factor.
Enable range for secondary algorithm

Check to set a range for the secondary algorithm so that, if the secondary algorithm is used, a result value
that falls below the minimum limit allowed or exceeds the maximum limit allowed fails.
Enable %C V C heck
If this field is enabled, the %CV between the replicates for each dilution point is calculated. If the %CV of
the replicates exceeds the corresponding value shown in the %CV Max. column in the Calibration Points
table for any dilution point, the calibration curve is flagged and fails. This check can only be enabled if the
number of replicates is two or more. (See Pre-diluted Calibrators for a screen shot displaying the Calibration
Point table.)
NOTE: When Enable %CV Check is selected, the pre-diluted calibrators, Min. Replicates, and %CV
Max values become user-definable.

Calibration Setup
Enable Outlier R emoval

If checked and there are at least three good replicate results for a concentration, the replicate with the value
furthest from the mean is discarded. After the outlier is removed, the mean of the replicates is recalculated.
Enable 0% D ilution Target Value

Check to override the automatic target value concentration for a 0% calibration dilution with a manually
entered non-zero value, provided the new value is less than the target value of the next dilution. This ensures
calibrations with transformations for which zero is illegal produce failed results for the 0% dilution. The abil-
ity to configure this value on a test-by-test basis preserves the true zero value for those tests for which there
is no transformation conflict, such as D-Dimer HS.
Measured R esult on X A xis

If checked, calibration measured results are plotted on the X axis.
Enable Math Model Low

Some factor tests require multiple math models applied to different areas of the calibration curve to obtain the
best fit. If checked, you can define an additional math model in the Math Model Low tab.
NOTE: If both math model high and math model low are used, the first math model must include the
highest concentration but not the lowest; the second math model must include the lowest concentration but
not the highest.
Math Model Tab (or Math Model High)

Math Model
Select a linear curve fit, spline curve fit, or Polynomial order 2 through Polynomial order 6 for
the math model. This field is locked for IL tests.
NOTE: If both math model high and math model low are used, the first math model
must include the highest concentration but not the lowest; the second math model must
include the lowest concentration but not the highest.
Spline
Enables a Monotonic check to ensure that within a given range of values there is only one
result possible. Spline curves that move both up and down, and hence could have more than
one calibrated result for a single measured value, are failed.
Linear R egression
Enables the lower part of the screen to allow selection of Enable slope check and Enable Y-
intercept check.

Chapter 4 – Setup
l Enable Slope Check – Verifies the slope of the calibration curve is within the specified
tolerance of the expected slope.
o Expected Slope – Target slope value for the test. The default is 1.000.
o Tolerance – Acceptable deviation around the expected slope in percent. The
default is 10.
o Range – Acceptable range for slope automatically calculated from the expected
slope and tolerance values.
l Enable Y-intercept Check – Verifies that the y-intercept of the calibration curve is
within the expected tolerance.
o Expected Y-Intercept – Target y-intercept value for the test. The default is
0.000.
o Tolerance – Acceptable deviation around the expected y-intercept in percent.
The default is 10.
o Range – Acceptable range for y-intercept automatically calculated from the
Expected Y-Intercept and Tolerance values.
Polynomial Order 2-6

These math models are available to improve curve fit. If a polynomial fit is selected, you can
enable the Monotonic check to ensure that within a given range of values there is only one
result possible. Curves that move both up and down, and hence could have more than one cal-
ibrated result for a single measured value, are failed.
Transformations
Read-only fields for IL locked tests that display the mathematical transformations applied to
the measured results and the calibration dilution target values, to aid in making the calibration
curve more linear. For user-defined tests, transformations can be enabled for any of the math
models.
X-A xis transformation

Converts the X data into a value that produces a linear curve fit. The available transformations
are:
l No transformation
l x2
l x1/2
l Log10(x)
l Log10(Log10(x))
l Ln(x)
l ex
l 10x

Calibration Setup
l 1/x
l x =x/x(0)
l x2.5
l 1/x1/2
l (Ln(x))2
Y-A xis transformation

Converts the Y data in order to obtain a linear curve fit. The available transformations are:
l No transformation
l y2
l y1/2
l Log10(y)
l Log10(Log10(y))
l Ln(y)
l ey
l 10y
l 1/y
l y = y/y(0)
l y2.5
l (Ln(y))2
l 1/y1/2
Enable Trend Check

Verifies that all of the measured results generated for the calibration curve follow a trend in
measured result signal. This means that all data points increase in value as the concentrations
decrease, or all data points decrease in value as the concentrations increase. (Calibration curves
with data that do not follow a trend are failed.) See Data Flags, CA 5566.
Enable Monotonic Check

Checks each segment (interval) of the curve (a segment is between two calibration points) to
ensure there are no local maxima or minima within that segment. Curves that move up and
down within calibration points are failed. See Data Flags, CA 5567. This check is disabled for
the linear regression math model.
Enable R2 Check
Verifies that the coefficient of determination (R2) is greater than or equal to the specified
value. The minimum R2 is the minimum acceptable value for R2. The default is 0.985.

Chapter 4 – Setup
NOTE: The R2 value is calculated using floating point values. Display of the values is
limited to 3 decimal places, so the actual values are rounded to the third decimal place. Due to
this rounding, a failed R2 value that is displayed on-screen may appear to be identical (but is
not identical) to the one defined in the test definition that is used to determine if the value
fails or not.
First Concentration
Defines the first point to use for this calibration segment.
Last Concentration
Defines the last point to use for this calibration segment.
Math Model Low Tab

Some factor tests require the use of two different math models at different calibration dilutions
to provide the best fit in the specific dilution ranges. Two curve segments, high and low, are
used, with each segment having a different math model. The setup of the low math model is
identical to that described for the high math model, with the exception that a cutoff point can
be defined.
Cut-off
Defines which calibration segment to use for calculating calibrated results from measured
results.
Value
Measured results that are less than the specified value are converted to calibrated results using
the high math model segment. Measured results greater than the specified value are converted
to calibrated results using the low math model segment.
B y concentration
Measured results less than the value corresponding to the selected calibration dilution are con-
verted to calibrated results using the high math model segment. Measured results greater than
the value corresponding to the selected calibration dilution are converted to calibrated results
using the low math model segment.
The curve is displayed in the Calibration Status List screen. See Calibration/Review and Val-
idation.

Calibration Setup
Automatic Dilution Screen

Use the Automatic Dilution screen to obtain the calibration points from one calibrator material.
General Tab
Dilution Points
D efine Points by % D ilution

If selected, for each dilution point the concentration field is enabled for editing and defines a calibration
point. The calibration point target value field is disabled for editing and is calculated from the calibrator
assigned value and the corresponding calibration dilution concentration.
D efine Points by Target C oncentration

For user-defined tests, if selected, for each dilution point the calibration point target value field is enabled for
editing and defines a calibration point. The calibration dilution concentration field is disabled for editing and
is calculated from the calibrator assigned value and the corresponding calibration point target value. The
resulting calibration curves have concentration points (X-axis) that are always the same regardless of the cal-
ibrator lot. Define points by target concentration can only be used if sample pre-dilution is enabled for the
test. If sample predilution is not enabled and the target value entered is greater than the calibrator target
value, the screen displays blank volumes. If you save, an inconsistency message is displayed: Calibration:
Dilution point definition mode by target is only available with Sample Pre-dilution enabled.
The Define points by target concentration option is used when the calibration is based on the assigned
value, which may change from lot to lot. (Refer to the calibrator insert sheet. )

Chapter 4 – Setup
Example
If you use this option to calibrate a factor test with a calibrator having a value of 80% activity, the dilutions
are adjusted so that the 100%, 50%, 20%, 10% and 5% target concentrations are maintained. This could also
work for an insert sheet value of 120% activity where the calibrator dilutions would be adjusted so that the
100%, 50%, 20%, 10% and 5% activities are maintained. In this instance, no matter what the calibrator
assignment value is, the calibration target values for the particular test would always be 100%, 50%, 20%,
10% and 5% activities.
C alibrator Target Value a n d U n it

Calibrator assigned value for the active lot of the calibrator. The calibration unit is the unit used when defin-
ing the assigned value.
Dilution Process
D irect
With serial dilution, the transfer of calibrator to cuvette during calibration introduces a slight dilution of the
calibrator, which is intrinsic to any syringe-driven fluidic system. This dilution is the reason for a slight dis-
crepancy in measured results between the calibrator run as part of the calibration cycle and the same cal-
ibrator run as a sample.
If you select Direct, each calibrator level is prepared directly from the calibrator vial instead of from the pre-
vious serial dilution, reducing the number of material transfer steps and minimizing unwanted dilution.

Calibration Setup
Serial
If you select Serial, neat calibrator1 is first transferred to an aliquot cuvette before being transferred to the reac-
tion cuvette. Each successive dilution is prepared from the dilution preceding it.
1Undiluted calibration plasma (100% strength).

Chapter 4 – Setup
Single D ilution
If you select Single dilution, the dilution sequence (calibration plus sample pre-dilution) for a particular cal-
ibrator level is prepared and sent to a reaction cuvette before preparing the next dilution level.
NOTE:

Calibration Setup
l All replicates of a particular dilution are processed in the same cuvette strip.
l Preparation of the next dilution does not begin until all the dilution steps of the previous dilution are
complete.
B atch
If you select Batch, all dilutions (calibration plus sample predilution) for all dilution levels are prepared
before the reaction processing starts. Replicates of different dilutions can be mixed in a cuvette strip.
Calibration Definition Table
Calibration Points Definition

For each dilution point the following fields are defined:
C oncentration
To enter a concentration:
1. Double-click the first cell in the column.
2. Enter the concentration in terms of percent (i.e., enter 100 for 100%).
The system accepts concentrations up to 200%.
NOTE: For concentrations greater than 100%, sample pre-dilution must be enabled and defined.
Because the system automatically calculates the volumes required to make the calibration dilutions, you must
enter concentrations in the order highest to lowest. At least three (3) concentrations are required in order to
perform a calibration and up to eight (8) concentrations are allowed.
Target Value
After you select the calibrator material and define the assigned value, each concentration target value is auto-
matically calculated. If a calibrator material has not been selected or the assigned value defined, the Target
Value column displays 0.00 for each concentration.
Target values are automatically updated after the missing information is entered and saved.
NOTE: The following volumes are not computed until you define the Test Definition Load Cycle,
and, if using concentrations greater than 100%, until Sample Predilution has been enabled and defined.

Chapter 4 – Setup
Min. R eplicates
The minimum number of valid replicates per calibration point to validate a calibration result.
% C V Max.
Maximum %CV for each calibrator concentration that is allowed. If the %CV is greater than the maximum
specified here, that calibration point fails.
C alibrator Volume
Read-only display of the total amount of calibrator, in μL, that is required to prepare the dilution.
NOTE: All replicates (max of 6) of every dilution (max of 8) that are run for calibration of a test
must use calibrator from the same bottle placed on-board. (6 replicates X 8 dilutions = 48 tests.) Factor tests
require more calibrator than is available in a 1 mL bottle. You must pool 2 bottles and place it on-board
before starting the calibration tests.
Mixture Volume
Read-only display of the total amount of the previous concentration, in μL, that is required to prepare the
dilution.
D iluent Volume
Read-only display of the total amount of diluent, in μL, that is required to prepare the dilution.
Calibration Data Point Checks
Select the View icon to display the DR Checks Configuration window for the concentration having
focus.

Calibration Setup
Use this window to apply some, all, or none of the data checks to specific concentrations. To select a data
check to apply to a specific dilution, the data check must be enabled and defined for the test within the test
setup. DR check is only available for Automatic dilution. It is not available for pre-diluted calibrators.
Enable Mix
Activates the mix parameters for editing.
Mix
Uses the mix volume percentage to calculate the volume of material that is aspirated from the cuvette cell
and re-dispensed into the same cuvette cell to facilitate a mix. The mix volume is calculated as follows:
l Mix Volume = (Total cuvette volume – Cuvette dead volume) * Mix %
N umber of C ycles
Number of mix cycles to be performed.
l Minimum: 1
l Maximum: 3
l Default: 1
R inse A fter Mix

Amount of time, in seconds, to rinse the probe after a mix has been performed.
l Minimum: 1 sec
l Maximum: 5 sec
l Default: 1 sec
Minimum A spiratable Volume

Specifies the minimum volume of calibrator to use when making a dilution. Because the system auto-
matically performs dilution calculations, it tries to use the smallest possible volume (4µL) when performing
calculations. By entering a value greater than 4µL, the system is forced to use volumes no less than the
entered volume when making dilutions.
l Minimum: 4 μL
l Maximum: 50 μL
l Default: 4 μL
Pre-Dilution volumes
When sample pre-dilution is enabled, the system computes the number of steps needed to generate enough
volume of diluted calibrator for each calibration dilution point. The chart shows the calibration point pre-dilu-
tion sample volume, mixture volume, and diluent volume for the indicated dilution point. See Sample Pre-
dilution.

Chapter 4 – Setup
D ilution Point
To prepare concentrations greater than 100%, the system alters the sample predilution parameters to use a
larger volume of calibrator and a smaller volume of diluent. When entering a concentration greater than
100% in the Calibrator Volumes table, the only volume displayed is the total calibrator volume required to
prepare all replicates.
In the Calibration Definition table, the 150% dilution point is selected and its corresponding altered sample
predilution volumes are displayed in the Predilution volumes area. Note that volumes in cells with a blue
background are delivered directly to the reaction cuvette, or if predilution is enabled for the test, to the pre-
dilution cuvette.

Calibration Setup
Calibrator Tab
Volumes
The calibrator liquid volume is the same as the one defined for the sample material in the load cycle.
Material
Name of the material to use as calibrator. The calibration material may be adjusted on copied (open) tests
only. Material must be defined as a Calibrator/NPP type. You can access available materials using the drop
down list.
H ead Volume
See Pre-Dilution - Head Volume.
A irgap
See Pre-Dilution - Airgap.
Transport A irgap
See Pre-Dilution - Transport Airgap.
H ead Volume A irgap

See Pre-Dilution - Head Volume Airgap.
Rinse
Time
l Minimum: 1 sec
l Maximum: 5 sec
l Default: 1 sec

Chapter 4 – Setup
Diluent Tab
Volumes
Material
The diluent material is selected from the drop down list that includes only sample diluent type materials.
For a diluent material, the rinse and clean parameters are defined in the Material Definition. All other cal-
ibration definition fields in the diluent tab area are identical to those of the calibrator tab described above.

Calibration Setup
Pre-diluted Calibrators Screen

If the calibration mode is set to Prediluted calibrators, you can use the Pre-diluted Calibrators screen to set
up the list of calibrators to define the pre-diluted calibration points. See Accessing the Pre-diluted Calibrators
screen.
Column Headings
C alibrator Material
For each dilution point, click the Calibrator Material table cell, then select the calibrator material from a
drop down list.
NOTE:
l Calibrators must be previously defined in the Material List before you can select them from the Cal-
ibrator Material drop down list.
l Each pre-diluted calibrator material can only be selected once in the same list of pre-diluted cal-
ibrators.
l All pre-diluted calibrators must have the same lot management configuration as defined in lot man-
agement and alternate lot in material definitions.
Target Value
The target value is the known concentration of the calibrator.
The advantage of entering target values instead of dilution percentages is that calibration dilutions have the
same value regardless of the assigned value of the calibrator.
Min. R eplicates
The minimum number of valid replicates per calibration point required to produce a valid calibration. Mini-
mum = 1. Maximum = 6.

Chapter 4 – Setup
%C V Max
The maximum %CV for each calibration dilution that is allowed. If the %CV is greater than this value, that
calibration point fails.
Min. Replicates and % CV Max. are calculated by the instrument, and the fields are automatically pop-
ulated after you select the calibrator material. If Enable %CV check is enabled on the Calibration – DR
Parameters tab, both of these settings are user-definable.
See Also
l Calibration Details
l Calibration Status List
l Performing a Calibration
l Parallelism
l Rerun Rules

Configuring Factor Parallelism

This topic describes how to set up parallelism testing on the Parallelism screens.
Overview
Factor parallelism increases the quality of test results and identifies causes of interference that may affect
those results.
Regulatory bodies recommend a minimum of 2-3 dilutions of plasma for factor tests. A reportable dilution
should fall within the working range of the test. Ideally, dilutions of test plasma should be the same as those
of the calibrator1. The test results of the various plasma dilutions should parallel the calibration curve.
The criteria to define ”parallelism” are based on statistical or mathematical analysis that might employ, for
example, a comparison of the slopes of the curve obtained with the test plasma dilutions versus the slope of
the calibration curve, a check of the r2 of the parallelism curve or a check of the variance between the recal-
culated results of the first sample dilution (100%) and the subsequent dilutions.
The ACL TOP instrument offers a wide range of mathematical data-checks which, if enabled by the operator,
allow the determination of parallelism. The system also displays default-criteria for each data-check that can
be customized. Since there are no official guidelines that establish these criteria, they can be defined accord-
ing to the discretion and needs of the individual laboratory.
As mentioned above, the factor parallelism feature allows the detection of interference to the test. In par-
ticular, the presence of heparin, lupus anticoagulants or specific factor inhibitors may affect the results of the
single factor tests; therefore, performing the testing with different dilutions of the test plasma may assist in a
diagnosis.
Lupus anticoagulants may prolong APTT and PT clotting times, depending on the sensitivity of the reagent
used. In these cases, plasma test dilutions could have the effect of increasing the calculated % activity of the
increasingly diluted replicates.
Unfractionated heparin usually prolongs the APTT clotting times. Therefore, when testing a single hep-
arinized sample for factor activity in the standard test, the presence of heparin may interfere and cause falsely
low factor activity. When tested in the parallelism mode, the multiple sample dilutions can serve to dilute the
heparin effect with each increasing dilution, and as a consequence result in higher % factor activities with
subsequent dilution.
Factor inhibitors, on the other hand, may or may not be detected with the parallelism function.
The ACL TOP instrument provides a unique competitive advantage for testing of factors. Although most of
the major competitors offer the ability to test multiple factor dilutions, only the ACL TOP instrument pro-
vides a sophisticated and comprehensive array of options to automatically assess the results.

Chapter 4 – Setup
Factor Parallelism Testing Options

For each factor test the ACL TOP instrument provides two testing modes:
l Standard Factor (single dilution) – The sample is measured at a pre-defined dilution ratio. Results are
provided in seconds and % activity.
l Factor Parallelism (up to four dilutions) – The sample is measured at different dilution levels (typ-
ically three, up to four).
The system can also detect whether the sample dilutions curve is parallel to the calibration curve. Non-par-
allelism can indicate interference in the patient sample, possibly due to heparin, lupus anticoagulants or fac-
tor inhibitors.
Testing Options
The following sections and examples describe the factor parallelism testing options available on the ACL
TOP instrument:
l Factor Parallelism Reporting Units
l Factor Parallelism Criteria
l IL Tests Default Criteria
l Definition and Use of Factor Parallelism
l Examples of Factor Parallelism Results
Factor Parallelism Reporting Units

When defining a factor parallelism test, you may select up to four units on the to display on the screen and
include in the results printout.
The following test definition screen shows where the selection of the units is made (drop-down options from
unit 1 to 4):

All selected units are always displayed in the parallelism result details screen.
The following parallelism units are available for selection:
Mean of 100%
The system calculates the % activity of the 100% dilution. If more than one replicate is defined (up to three),
the mean is provided.
While all the available units are specifically intended to aid in the determination of the parallelism, this par-
ticular unit provides information only about the 100% dilution.
Mean of Corrected Results (CR)

The system calculates the % activity of each sample plasma dilution (excluding the 100% dilution) and cor-
rects each corresponding % activity result to compensate for the dilution factor (Corrected Results). It then
calculates the mean of these corrected results.
Example
Dilution (%) % Activity CR %
100 96 96
50 47 94
25 23 92
The Mean of Corrected Results (CR) in this example is 93% (mean of 94% and 92%).

Chapter 4 – Setup
%CV of Corrected Results (CR)

The system calculates the % activity of each sample plasma dilution (excluding the 100% dilution) and cor-
rects each corresponding % activity result to compensate for the dilution factor (Corrected Results). It then
calculates the %CV of these CR results.
Example
100 96 96
50 47 94
25 23 92
The %CV of Corrected Results (CR) in this example is 1.5% (CV % of 94% and 92%).
Mean of Corrected Results (CR) 100%

This is the same as the Mean of Corrected Results but this calculation includes the 100% dilution result in
the mean calculation.
Example
100 96 96
50 47 94
25 23 92
The Mean of Corrected Results (CR) 100% in this example is 94% (mean of 96%, 94% and 92%).
%CV of Corrected Results (CR) 100%

This is the same as % CV of Corrected Results but this calculation includes the 100% dilution in the CV cal-
culation.
Example
100 96 96
50 47 94
25 23 92
The %CV of Corrected Results (CR) 100% in this example is 2.1% (CV % of 96%, 94% and 92%).

Slope
The system computes the slope of the sample dilution results which make up the parallelism curve. The slope
is calculated using the math model defined in the parallelism Transformation fields.
Example
NOTE: The following examples are not test-specific and are given for information only.
FVIII Calibration [Y = sec; X = ln(% FVIII)]
Dilution% Target % FVIII ln(% FVIII) sec

130 140.4 4.94 45.3
100 108 4.68 48.1
40 43.2 3.77 57.4
5 5.4 1.69 81.3
1 1.1 0.10 95.4
Slope -10.508
Intercept 97.39
r2 0.998
Parallelism dilutions [Y = sec; X = ln(% Dilution)]
dilution% ln(% FVIII)) sec % CR%

100 4.61 45.8 135.8 135.8
50 3.91 52.8 69.6 139.2
25 3.22 59.2 37.8 151.2
Slope -9.666
Intercept 90.414
r2 0.999
The reported parallelism slope in this example is -9.666.
r2
The system computes the r2 of the parallelism curve. The r2 is calculated using the math model defined in
the parallelism Transformations fields. See example in slope unit: the reported parallelism r2 is 0.999.

Chapter 4 – Setup
y-Intercept
The system computes the y-intercept of the parallelism curve. The y-intercept is calculated using the math
model defined in the parallelism Transformations fields. See example in slope unit: the reported y-intercept in
this example is 90.414.
Factor Parallelism Criteria

The system provides a number of criteria to evaluate the factor parallelism data.
These criteria are enabled and configured in the same screen where the parallelism units are defined. For your
convenience the screen is included again below:

IL Tests Default Criteria

The following criteria are available:
Slope Check
If this check is enabled, the system compares the slope of the parallelism curve to the slope of the calibration
curve. The acceptable slope range is definable by means of acceptable % deviation around the calibration
slope (tolerance). After the tolerance is defined, the system displays the acceptable range. If the parallelism
slope falls outside the acceptable range, the following flag is generated:
Code Flag Message W/E
5254 RW Slope out of range W
r2 Check
If this check is enabled, the system verifies that the r2 of the parallelism curve is greater than or equal to the
specified value (Min r2). If not, the following flag is generated:
5255 RW Parallelism r2 out of range W
Variance Check
If this check is enabled, the system computes the percent difference between the average corrected result at
each concentration and the average result at 100%. If any of the dilutions have a percent difference that
exceeds the Max. Variance, the following flag is generated:
5253 RW Max. variance of parallelism dilution out of range W
%CV of Corrected Result (CR)

If this check is enabled, the system calculates the %CV of the corrected primary results excluding the 100%
dilution, and compares it against the maximum %CV defined (Max %CV). If the maximum %CV is
exceeded, the following flag is generated:
5259 RW %CV of the CR is greater than the maximum %CV allowed W
%CV of Corrected Result (CR) and 100%

If this check is enabled, the system calculates the %CV of the corrected primary results, including the 100%
dilution, and compares it against the maximum %CV defined (“Max %CV”). If the maximum %CV is
exceeded, the following flag is generated:

Chapter 4 – Setup

5260 RW %CV of the CR and the 100% dilution is greater than the maximum %CV W
allowed.

Determining Factor Activity Using Factor Parallelism (multiple sample

dilutions)
Factor parallelism is configured in the Parallelism screen.
Number of dilutions
For user-defined tests, up to four dilutions can be defined, with the 100% dilution point being mandatory. IL
Tests that use factor parallelism have three dilutions defined.
Primary U nit
The primary unit is the calibrations unit used to display the parallelism results. Default options for IL locked
tests are % and U/mL.
Units from 1 to 4 are user selectable for results display and printing. See: Factor Parallelism Reporting Units,
above.
U nit 1
Select Mean of 100%. This provides the average % activity obtained at the different dilution levels (usually
three dilutions are selected).
U nit 2
Mean of 100%.
U nit 3
%CV of Corrected Results 100%.
U nit 4
Can be left blank.
Selecting the Criteria

Enable the Variance check option to flag those results with significant discrepancies among different sample
dilutions. The sample should undergo further analysis before factor activity results are reported. In addition to
variance check, other parallelism criteria may be enabled.
The following checks can be enabled:
Slope Check
This check is used to establish a proper tolerance value between the slope of the parallelism curve compared
to the slope of the calibration curve. Measurement of some known samples (with and without factor inhib-
itor) starting with a tolerance value of 15% can help define the desired tolerance to discriminate between nor-
mal samples and abnormal samples. Observe the flagging and eventually modify this threshold as needed
(sample results re-calculation can be used to test the effect of the changes without having to re-run the sam-
ples).

Chapter 4 – Setup
r2 Check
This is the same as for the check above; start testing with a min r2 value of 0.980.
Variance Check
This is the same as for the check above; start testing with a max variance value of 20%.
%CV of CR
This is the same as for the check above; start testing with a max %CV value of 15%.
%CV of CR and 100%

This criterion is very similar to the %CV of CR; if it is used in the definition of the max CV%, consider that
the inclusion of the 100% usually leads to lower CV%.
Reporting Factor Activity Results

If an inhibitory pattern is not found, then report the first dilution whose uncorrected % activity result falls
within the linearity of the test.
If an inhibitory pattern is determined to be present, more dilutions may be required to determine accurate fac-
tor level.

Examples of Factor Parallelism results

Normal Sample
Sample with inhibitors
NOTE:

Chapter 4 – Setup
l The College of American Pathologists (CAP) guidelines require at least 2 dilutions be tested before a
factor test is reported. This requirement was instituted as a tool for identification of inhibitors and/or
activators. In conjunction with these guidelines, IL suggests making three (3) dilutions per sample to
be tested for factors. The dilutions should be chosen according to an individual facility's protocol.
Additional dilutions are not made to guarantee precision of recovery
l After the dilutions are tested, the results should be reviewed. Two consecutive values with laboratory-
defined maximum variance (for example, less than or equal to ± 20%) indicate acceptable results. Be
certain to use only values within the calibrated range for this assessment. Average the two (2) accept-
able results and report.
Example Calibration Plasma Test Factor VIII 100%

Laboratory Maximum Variance ± 20%
Dilutions: 1:10 1:20 1:40
Values: 98% 92% 106%
The 98% and 92% pair meets the criteria for within the calibrated
range and within ± 20% of each other.
The 92% and 106% pair does not meet the criteria. Report 95%, the
average of 98% and 92%.
See Also
l Parallelism

Parallelism Setup
Parallelism Setup
Overview
Use the Parallelism Definition screen to:
l Enable or disable parallelism for the current test.
l Configure the analytical cycle and data reduction parameters used when performing factor parallelism
studies.
You cannot enable parallelism if any of the following conditions apply:
l The test is a paired test.
l The test is a shadow test.
l Calibration is not enabled.
Viewing and Editing the Parallelism Definition Screen

To open and edit the Parallelism Definition screen:
3. In the Test Definition screen, select Parallelism in the navigational tree.
4. <Optional> Edit the parallelism fields on the Analytical Cycle and Data Reduction tabs.
6. Select the Previous Screen icon in the toolbar to return to the Test List..

Chapter 4 – Setup
Parallelism Definition screen
Enable parallelism
Option to run parallelism tests. Enables the fields on the Parallelism screen.
Parallelism LIS number

Unique parallelism mode test ID number for the Laboratory Information System (LIS).
Test code
Unique parallelism test identifier appended by the character defined in the Parallelism mode extension option
in Global Definitions.

Parallelism Setup
Analytical Cycle Tab

Number of Replicates
Number of repeat measurements to perform on a parallelism dilution.
l Minimum: 1
l Maximum: 3
l Default: 1
Diluent Material
Diluent material name extracted from the Calibration Definition – Diluent tab. Read-only for IL locked tests.
Dilution Process
Dilution process used for this test. It is read-only for IL locked tests.
D irect
Option to make all parallelism dilutions directly from the sample cup.
Serial
Option to transfer the sample to an aliquot cuvette before transferring it to the reaction cuvette. Successive
dilutions are made from the previous dilution mixture.
Single dilution
Option to prepare the dilution sequence (parallelism plus sample pre-dilution) for a particular parallelism
level and transfer it to a reaction cuvette before starting the preparation of the next dilution level.
NOTE:
l All replicates of a particular dilution are processed in the same cuvette strip.
l Preparation of the next dilution does not begin until all dilution steps of the previous dilution are
complete.
B atch
Option to prepare all dilutions (parallelism plus sample pre-dilution) for all dilution levels before the reaction
processing starts. Replicates of different dilutions may be mixed in a cuvette strip.
Dilutions Table
This table lists the dilutions. For user-defined tests, up to four dilutions can be defined, with the 100% dilu-
tion point being mandatory. IL Tests that use factor parallelism have three dilutions defined.

Chapter 4 – Setup
Data Reduction Tab
Parallelism Point Units
Primary U nit
Calibrated unit used to display parallelism results. You can select any defined calibration unit. Options for IL
locked tests are % and U/mL. If the unit is changed from the default value, parallelism results must be recal-
culated to update the patient information with the new unit and its respective values. The parallelism graph
is still displayed using the unit defined for the calibration.
NOTE:
l You must have a validated calibration for the test before running the parallelism test.
l Statistical results based on the corrected results (mean CR, %CV of CR, etc.) displayed in both the
Parallelism Detail screen and the Sample List screen are in terms of the primary calibrated unit.
Units
Select up to four result units for parallelism from the following list for results display and printing:
l Mean of 100%
l Mean CR
l Mean CR 100%

Parallelism Setup
l Slope
l r2
l y-intercept
l %CV of CR
l %CV of CR 100%.
See Determining Factor Activity for an example of configuring this setting.
Enable Slope Check

Option to generate an error message when the slope of the parallelism curve falls outside the expected range.
See Determining Factor Activity for an example of configuring this setting.
Target Slope
Read-only value of the slope of the validated calibration curve calculated using linear regression and the par-
allelism transformations.
Tolerance
Acceptable deviation from the target slope in percent.
l Minimum: 0
l Maximum: 100
l Default: 10
R ange
Acceptable range for the slope, calculated automatically from the target slope and tolerance values.
Transformations
Read-only values for IL locked tests. They display the transformations, if any, that are used for the current
test. For user-defined tests, transformations can be enabled for any of the math models.
X A xis Transformation
Selections are:
l No transformation
l 1/X
l X2
l X1/2
l 1/X1/2
l Ln(X)
l Log10(X)
l Log10(Log10(X))

Chapter 4 – Setup
l 10X
l eX
l X=X/X(0)
l X2.5
l (1n(x))2
Y A xis Transformation
Selections are:
l No transformation
l 1/Y
l Y2
l Y1/2
l 1/Y1/2
l Ln(Y)
l Log10(Y)
l Log10(Log10(Y))
l 10Y
l eY
l Y=Y/Y(0)
l Y2.5
l (1n(Y))2
NOTE: For user-defined tests:

l If parallelism is defined after a calibration for that test has been validated, the calibration must be
recalculated to apply the correct parallelism transformation to the calibration to use in the parallelism
display. See Review and Validation for information on recalculation.
l If parallelism transformations are modified after parallelism results are obtained, both the calibration
and parallelism sample for that test must be recalculated to update the parallelism display.
l Failure to perform either of the above actions triggers a results warning 5568: Calibration and par-
allelism transformations do not match.
Enable r2 Check
Option to system-verify whether the coefficient of determination (r2) is greater than or equal to the specified
value. If not, an error is generated. See Determining Factor Activity for an example of configuring this set-
ting.
Min r 2
Minimum acceptable value for parallelism r2. The default value is 0.985.

Parallelism Setup
Variance Check
When selected, the system calculates the difference between the corrected primary result at 100% and each of
the means of corrected results at the other concentrations, and verifies that the computed % difference of the
concentration is less than the maximum % difference allowed. If the maximum variance is exceeded, an error
is generated. See Determining Factor Activity for an example of configuring this setting.
Max. Variance
This is the maximum acceptable percent difference allowed. The default is 15.
%CV of CR (corrected result)

When selected, the system calculates the %CV of the corrected primary results (excluding the 100% and 0%
dilutions) and compares it against the maximum %CV allowed. If the maximum %CV is exceeded, an error is
generated. See Determining Factor Activity for an example of configuring this setting.
Max. %C V
Maximum acceptable %CV allowed. The default is 15.
%CV of CR (corrected result) and 100%

When selected, the system calculates the %CV of the corrected primary results (excluding 0% dilutions) and
compares it against the maximum %CV allowed. If the maximum %CV is exceeded, an error is generated. See
Determining Factor Activity for an example of configuring this setting.
Max. %C V
Maximum acceptable %CV allowed. The default is 15.
See Also
l Configuring Factor Parallelism
l Calibration
l Rerun Rules

Chapter 4 – Setup
Normal Pool Plasma Setup

The NPP1 test definition screen allows you to define the NPP mode, material and frequency for a test.
Viewing and Editing the Normal Pool Plasma screen

To view and edit the Normal Pool Plasma screen:
3. In the Test Definition navigation tree, select Normal Pool Plasma.
4. <Optional> Edit the fields on the NPP General and Frequency tabs.
NOTE: Before using a new NPP definition to recalculate patient test results, the calibration must be
recalculated, saved and validated. Perform the following steps in sequence:
1. Change the NPP definition as desired and save the changes.
2. Select the desired calibration, recalculate, save the changes and validate. See Calibration Details.
3. Recalculate the patient results. See Recalculating Test Results.

Test Definition – Normal Pool Plasma Screen
Enable NPP
Option to configure the Normal Pool Plasma parameters. Enables the fields on the General and Frequency
tabs.

Chapter 4 – Setup
General Tab
NPP Mode
Select a mode in the NPP mode drop-down list.
D erived from C alibration

Enables the following options on the Method drop-down list:
l Mean of calibration point replicates – Uses the Mean of a specified calibration point to obtain the
NPP value. Enables the Calibration point list:
o Calibration point – List of calibration standards whose mean is used as the NPP value.
After you select the standard option in this list, the concentration and target value for
the standard displays to the right of the Calibration point list.
l Compute value from calibration curve equation – The NPP value used to calculate results is com-
puted from the calibration curve at the concentration/activity level you specify. Enables theNPP
value list.
o NPP value – Allows you to input the concentration/activity level used to compute the
NPP value.
Midpoint of N ormal R ange

Uses the midpoint of the normal range defined in result units to obtain the NPP value.
R un as Sample
An NPP material placed on board runs each time an NPP is ordered. Enables the NPP material list.
l NPP material – List of materials to use as NPP. The material must be defined as type Calibrator/NPP.
U ser Input N PP Value

Option to manually enter an NPP value. Enables the NPP field.
l NPP – Allows input of measured result values to use for calculations involving NPP.
Enable Adjust Calibration to NPP

Available for NPP values only when the calibrated result unit is percentage (%). Intended primarily for PT
tests. It can be used only for calibrations that use a linear regression math model. When enabled, the Cal-
ibration Details screen shows the original calibration curve (green) as well as the adjusted calibration curve
(purple).

NPP Calibration Curve screen

Chapter 4 – Setup
Frequency Tab
Enable Frequency
This option must be selected to edit frequency parameters and automatically run NPP calibration or to prompt
when calibration is due. This is only enabled if the NPP mode is Run as Sample.
Frequency
Enter the frequency to prompt for NPP calibration or run NPP calibration in terms of number of tests, hours or
days. Next, select the appropriate interval (tests, hours or days) from the drop down list.
NOTE: Only patient jobs are considered when counting the frequency by tests. QC jobs, calibration
points, and NPP points are excluded.
Enable Warning Threshold

Option to generate a warning when an NPP is due.
W arning Threshold
This establishes when to notify you that an NPP is due. If the frequency is set to Tests, the warning threshold
must also be in terms of Tests. Likewise, if the frequency is set to Hours, the warning threshold must also be
in terms of Hours. If the frequency is in terms of days, select the warning threshold in terms of either hours or
days.
Enable Automatic Execution

Option to automatically execute NPP when the frequency threshold is reached. Automatic execution can be
performed only if all the necessary materials are available on-board with sufficient volumes, adequate sta-
bility, and valid expiration dates.
See Also

l Calibration
l Parallelism
l Rerun Rules

Chapter 4 – Setup
Rerun Rules Setup
Overview
You can configure the ACL TOP instrument to automatically rerun a test based on result range violations or
data reduction conditions. If Rerun is enabled, and a defined test result is obtained, the test runs again on that
sample. You can configure rerun to do the following:
l Run same test.
l Run the same test using an extended acquisition time.
l Run the same test using an alternative pre-dilution on the sample.
NOTE: Parallelism, QC, and calibration cannot trigger a rerun.
Configuring Rerun Rules

To configure the rerun rules:
3. In the Test Definition navigation tree, select Rerun - Rules.
4. Configure the rerun rules on the Result Ranges and DR Errors tabs.

Rerun Rules Setup
Rerun Rules Screen
This screen contains two tabs – Result Ranges and DR Errors.
Enable Rerun
Option to rerun tests based on the rules configures in the Rerun Rules screen. Activates the rerun parameters
for editing.

Chapter 4 – Setup
Result Ranges Tab

Result Unit to Test
Select a result unit in the list to configure in the rerun rules.
Table columns
R ule
The available range result rules include:
l Above Normal Range
l Below Normal Range
l Above Therapeutic Range
l Below Therapeutic Range
l Above Linear Range
l Below Linear Range
l Above Test Range
l Below Test Range
l Above Extrapolation Range
l Below Extrapolation Range
l Above Secondary Algorithm Range
l Below Secondary Algorithm Range
l (Range) Above Measured Result Test Range
l (Range) Below Measured Result Test Range.
Same Test / Extended Test / A lternative pre-dilution

To select a rerun rule, select Same Test, Extended Test, or Alternative Pre-Dilution.
NOTE:
l To use a range rule, the test result ranges must have been pre-configured in the Result Unit Definition
screen.
l To use extended test, Extended Test Mode must be enabled and defined in the Analytical Cycle
screen.
l To use alternative pre-dilution, it must be enabled and defined in Alternative Pre-Dilution.
For example:
l If a sample returns a result with an Above Linear Range flag, and the rerun action is set to Alternative
pre-dilution, the sample is diluted according to the alternative pre-dilution setup, and the same test is
repeated.

Rerun Rules Setup
l If the sample returns a result with an Above Test Range flag, and the rerun action is set to Extended
Test, that sample reruns using the Extended acquisition time.
l If a sample returns a result with an Above Normal Range flag, and the rerun action is set to Same Test,
the same test is run again.
l If you have enabled Extended Acquisition Time configured in the Alternative Pre-dilution, and
Extended acquisition has been enabled in the Analytical cycle definition for that test, an alternative
pre-dilution rerun occurs using the extended acquisition mode. See Alternative Pre-Dilution.

Chapter 4 – Setup
DR Errors Tab
Generic failure on measured result

Options to select all the rerun rules in the corresponding column (only one column) for the test selected in
the Test List.
Table columns
R ule
This allows you to select some of the available DR Rules without having to select them all. They include:
l (Data) First point out of range
l (Data) Last point out of range
l (Data) Curve min. and max. not in correct sequence
l (Data) Curve sequence unknown
l (Data) Incorrect number of raw data points
l (Data) Too many invalid raw data points
l (Data) Number of spikes exceeds error limit
l (Data) Insufficient points remaining for calculation
l (Data) Normalized curve delta too high
l (Data) Normalized curve delta too low

Rerun Rules Setup
l (Data) Normalized curve delta less than lowest calibrator1 delta

l (Data) Baseline average high
l (Data) Baseline average low
l (Data) Baseline SD exceeds error limit
l (Data) Endpoint average high
l (Data) Endpoint average low
l (Data) Endpoint SD exceeds error limit
l (Coag) First derivative peak not found
l (Coag) Second derivative peak not found
l (Coag) Too many first derivative peaks
l (Coag) Too many second derivative peaks
l (Coag) First threshold limit not found
l (Coag) Second threshold limit not found
l (Coag) Max (min) time span violation
l (Reaction) Initial slope exceeds error limit
l (Reaction) Linear regression SD exceeds error limit
l (Data) Result exceeds negative value limit
l (Data) Result check failed
l (Data) Calculation error
l (Data) Interference error
l (Prep) Aspiration baseline error
l (Prep) Unexpected LLD error
l %Max difference of replicates exceeded
l (Data) Normalized data contains multiple thresholds
Same Test / Extended Test / A lternative pre-dilution

To create a rerun rule, select Same Test, Extended Test, or Alternative Pre-Dilution run. You must enable
and define extended test mode (Analytical Cycle Definition) and alternative pre-dilution (Alternative Pre-
Dilution) to use those rerun rules.
R erun Priority
If multiple rules are configured with different rerun responses, and multiple rules trigger a test rerun, only one
rerun occurs, according to the following priority:

Chapter 4 – Setup
l First priority: Alternative pre-dilution – Rules configured to rerun Alternative pre-dilution tests over-
ride the Extended Test and Same Test reruns.
l Second priority: Extended Test – Rules configured to rerun Extended Tests override Same Test reruns.
l Third priority: Same Test – Rules configured to rerun the Same Test activate only when there are no
rule violations configured for Alternative pre-dilution or Extended Test reruns.
See Also
l Calibration
l Parallelism

Consistency Check
Consistency Check
All parameter information for the test definition is verified for consistency and relationships between different
areas by means of a consistency check. After the consistency check is performed, the area of the Test Def-
inition screen located at the bottom of the screen provides information to help identify problems within the
test definition. On the navigational tree inconsistent areas are highlighted in red, starting with the first incon-
sistent area, to facilitate correcting the inconsistency. As each area becomes consistent, the next inconsistent
area is highlighted in red.
Performing a Consistency Check

To perform a consistency check:
2. Place focus1 on a test in the Test List, and select the Apply Checks icon in the toolbar, or
select Actions > Test > Apply Checks in the menu bar.
3. Locate and select the inconsistency in the navigational tree (red text) to open the respective screen.
4. Correct the inconsistent settings.
Consistency Check Window
Double-click an inconsistency message to open the screen with the inconsistent configuration. The incon-
sistent screen is identified in red text in the navigational tree.
See Also
l Test Definition

Chapter 4 – Setup
QC List
The read only QC List displays information from the QC Definition for QC materials and test pairings.
Accessing the QC List

To access the QC List:
1. Select Setup > QC List in the menu bar.
2. To filter the QC list, select the down arrow beside the Filter icon in the toolbar, then select
Enabled QC Definitions or Disabled QC Definitions in the submenu.
3. To view or edit a QC setup definition, double-click a test in the list, or place focus on a test code and
select the QC Definition icon in the toolbar.
4. To add a new QC definition, click the Add icon in the toolbar.

5. After creating or editing a definition in the QC Setup Definition screen, do one of the following:
l Select the Save icon in the toolbar to save your changes.
l Select the Restore icon in the toolbar to restore the original configuration.
6. Select the Previous Screen icon in the toolbar to return to the QC List.
QC List Toolbar
Add a new QC definition. Opens the QC Setup Definition screen.
View QC Definition details. Opens the QC Setup Definition screen for the test in focus.
Delete a QC Test. Deletes the selected test from the QC List screen. A test that is referenced
in one or more QC definitions cannot be deleted until these QC definitions are deleted.
Filter. Select Enabled QC Definitions, Disabled QC Definitions, or both from a drop down
list.

QC List
QC List screen
Selection C olumn
Click one or more rows to place check marks in this column, indicating selection of one or more tests.
Test C ode
Unique name of the test that is paired with the QC material in the Material Name column.
Material N ame
Name of the control material, a sample-like material typically having known amounts of analyte, which is
used to detect changes from stable system operation.
U nit
Result unit for the test using the selected QC material.
Target Mean
Expected mean for the test using the selected QC material.
Target SD
Expected standard deviation for the test using the selected QC material.
Test Enabled/D isabled

Indicates whether a test is enabled for use on the instrument.
See Also
l Quality Controls
l QC Overview
l QC Profiles List
l QC Results List
l QC Test Status List

Chapter 4 – Setup
QC Setup Definition
Accessing the QC Setup Definition screen

To access the QC Setup Definition screen:
1. Select Setup > QC List in the menu bar.
2. To filter the QC list, select the down arrow beside the Filter icon in the toolbar, then select
Enabled QC Definitions or Disabled QC Definitions in the submenu.
3. To view or edit a QC setup definition, double-click a test in the list, or place focus on a test code and
select the QC Definition icon in the toolbar.
4. To add a new QC definition, click the Add icon in the toolbar.

5. After creating or editing a definition in the QC Setup Definition screen, do one of the following:
l Select the Save icon in the toolbar to save your changes.
l Select the Restore icon in the toolbar to restore the original configuration.
6. Select the Previous Screen icon in the toolbar to return to the QC List.
QC Setup Definition screen

QC Setup Definition
Material Name
Drop down list where you select the control material for the QC being defined. Material must be defined as a
QC type. An alternate lot of a material is used for QC studies whose information does not affect the QC sys-
tem status and whose results are not able to flag patient samples. After you save the definition, the material
name cannot be changed.
Comments
Read-only field containing user-defined text imported from the Comments field in the Material Definition.
Test Code
In the drop down list, select the test code for which QC is being defined. After you save the definition for
this material, you cannot change the test code. You can select the same test code for a maximum of 20 dif-
ferent quality control materials. Thereafter the test code is no longer available for selection.
Unit
This field is enabled after the test code has been selected. Use the drop down list to select a result unit
defined for that test.
If you define a QC test with a calibrated result unit, the QC test is not feasible if there is no validated cal-
ibration.
Target (Active Lot)
Mean
Enter the expected mean for the test using the selected QC material.
SD
Enter the expected standard deviation for the test using the selected QC material.
Patient Flags
QC failed
Option to flag all patient results for this test when QC fails.
QC Expired
Option to flag all patient results for this test when QC becomes overdue.
Test Feasibility
Test not feasible when QC failed.

Option to make a test Not Feasible when the QC status changes from Passed to Failed. If this transition
occurs while the system is busy, active tests complete and the results are flagged. All other tests (pending,
not feasible) are not performed. When QC changes from Failed to Passed, these other tests become Feasible.

Chapter 4 – Setup
Enable Rules
Option to apply rules to check QC results. Select a rule to apply in the Selection column. The following
Rules are available:
l 1-2S
l 1-2.5S
l 1-3S
l 1-3.5S
l 2-2S
l 2 of 3-2S
l R-4S
l 3-1S
l 4-1S
l 7x
l 7T
l 10x
l % Rule
User Defined Deviation Rule

Defines the allowed percent deviation from the mean, and allows for compliance with RiLiBÄK standards.
Select one or two decimal places.
NOTE: If the % Rule is selected the User Defined Deviation Rule/Allowed Variance field is also
selected. When this rule is selected, the Allowed Variance field must contain a numeric value.
RiLiBÄK Conformance
Enable R iLiB Ä K root of means squared calculation

Option to use RiLiBÄK rules for calculating the root of means squared when defining the acceptable per-
cent variation from the root of means squared for a defined interval of points identified in the interval state
setting (for example, a date range or number of points) in the QC Results List filter.
A llowed variance
Drop-down list of percent values. Select a value for the acceptable percent variation as described in the pre-
vious paragraph.
Frequency
In this section, configure the instrument to run QC or to generate a warning message based on the number of
tests, number of hours, absolute time of day and at a reagent vial change. QC is performed automatically

QC Setup Definition
when all of the following conditions are met:

l Automatic execution is enabled.
l The configured thresholds or events are reached.
l The QC is feasible (materials on-board with sufficient volume and not expired).
l You have ordered a specific test related to the QC.
If any of the above conditions are not met, the system generates a warning and sets the QC status to Overdue.
NOTE: When Auto Run is configured in Global Definitions Setup, it only auto-executes a QC job
when By Absolute Time is configured.
B y tests
Option to configure the instrument to: 1) run QC (automatically, if enabled); or 2) generate a warning after
the specified number of tests have been performed (specify the frequency in the Number of tests field.
l Enable warning threshold – Option to generate a message to run QC when the warning threshold is
reached. Enter the number of hours/tests in the field beside this option.
l Automatic execution – Option to run QC automatically when the threshold number of Tests/Hours is
reached. Automatic execution can be performed only if all the necessary materials are on-board in suf-
ficient volumes, adequate stability, and valid expiration dates.
NOTE:
l After a QC job has finished running, the frequency timer for Tests/Hours resets to the starting point.
This is true whether the QC job is manually or automatically generated.
l A manually executed QC job that runs at the same time as a frequency-initiated QC job, does not
cause a duplicate QC test to run.
l The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By
Absolute Time.
Absolute Time.
l Only patient jobs are considered when counting the frequency by tests. QC jobs, calibration points,
and NPP points are excluded.
NOTE: Automatic execution of a QC job By tests or By hours occurs when all the following
conditions are met:
o Automatic execution is enabled.
o All the required materials for the QC test are on board.
o The QC test is feasible.

Chapter 4 – Setup
o An order has been created to run the test related to the QC. For example, to run a QC
job for Routine Control X for the test APTT, an APTT test must be ordered.
If Automatic execution is enabled By tests or By hours in the QC Setup Definition, and the
above conditions are not met when the frequency is due, the system generates an alarm indi-
cating that QC is not feasible, or QC is overdue.
B y hours
Option to configure the instrument to: 1) run QC (automatically, if enabled); or 2) generate a warning after
the specified number of hours have passed (specify the frequency in the Number of hours field.
l Enable warning threshold – Option to generate a message to run QC when the warning threshold is
reached. Enter the number of hours/tests in the field beside this option.
l Automatic execution – Option to run QC automatically when the threshold number of Tests/Hours is
reached. Automatic execution can be performed only if all the necessary materials are on-board in suf-
ficient volumes, adequate stability, and valid expiration dates.
NOTE:
l After a QC job has finished running, the frequency timer for Tests/Hours resets to the starting point.
This is true whether the QC job is manually or automatically generated.
l A manually executed QC job that runs at the same time as a frequency-initiated QC job, does not
cause a duplicate QC test to run.
Absolute Time.
Absolute Time.
conditions are met:
B y A bsolute Time
Option to configure the instrument to run QC at a specified time of day or generate a warning. Select one or
more of the following options and enter a time of day. This option sets the starting time for the By Hours
option if selected in this screen.

QC Setup Definition
l First time – Check option and configure the time in the adjacent field.
l Second time – Check option and configure the time in the adjacent field.
l Third time – Check option and configure the time in the adjacent field.
l Fourth time – Check option and configure the time in the adjacent field.
Example
If First time is configured as 07:00, and Number of hours configured as 8, the instrument runs QC or
generates a warning message at local times: 15:00, 23:00, and 07:00.
Automatic execution
Option to run QC automatically at the times specified in this parameter. Automatic execution can be per-
formed only when all the following conditions are met:
l All required materials are on-board in sufficient volumes
l The on-board stability parameters in Material Definition have not been exceeded.
l If you have enabled Auto Run in Global Definitions Setup, or have manually ordered a test associated
with the QC.
NOTE:
l A QC job triggered by a By Absolute Time setting resets the frequency timer for By Test and/or By
Hours.
Absolute Time.
NOTE: If Automatic execution of a QC job By Absolute Time is selected in the QC

Setup Definition, and Auto Run is selected in Global Definitions Setup, QC automatically
executes the QCs at the defined times if the following conditions are met:
B efore vial use

Option to run automatic QC if any of the vials used for the specific assay (start or intermediate reagents) have
changed. This is not recommended if you are using more than one reagent, because a vial change of an inter-
mediate or start reagent forces a QC, even if one has just been performed.
NOTE:
l This frequency option is independent (and in addition to) the By Tests, By Hours and By Absolute
Time frequency options.
l When this frequency option is selected, automatic QC executes (in addition to other frequency-ini-
tiated QC jobs).

Chapter 4 – Setup
l If a QC job is triggered by the Before vial use option, the By tests and By hours frequency timer resets
to the starting point.
See Also
l Quality Controls
l QC Overview
l QC List
l QC Profiles List
l QC Results List

Test Profiles List
Test Profiles List

The Test Profiles List contains a list of all test profiles1 currently defined on the system. The ACL TOP instru-
ment can store up to 100 test profiles, each containing up to 15 individual tests.
Accessing the Test Profiles List

To access the Test Profiles List:
1. Select Setup > Test Profiles List in the menu bar.
2. To view a test profile, place focus2 on a profile in the Test Profiles List, and select the Profile
icon in the toolbar. View the test profile in the Profile Definition screen.
3. To delete a test profile, select3 one or more profiles in the Test Profiles List and select the Delete
icon in the toolbar. Confirm the deletion.
1A test profile is a grouping of tests. When you associate the test profile with a sample, all the tests in the
profile run on sample.
one object.

Chapter 4 – Setup
Defining a New Test Profile

To define a new test profile:
1. Select Setup > Test Profiles List in the menu bar to open the Test Profiles List.

3. In the Profile Definition screen, enter a name and description for the new test profile.
4. Use the arrow buttons to move selected test codes from the Available tests window to the Selected
tests window.
NOTE:
l The Available tests window contains only enabled test definitions. The Selected tests
window contains the test definitions to add to the test profile.
l You cannot duplicate tests within a single profile.
6. Select the Previous Screen icon in the toolbar to return to the Test Profiles List.

Test Profiles List
Configuring the Standard Test Profile

To configure the Standard Profile:
1. Select Setup > Test Profiles List in the menu bar to open the Test Profiles List.
2. Select1 a profile in the Test Profiles List.
3. Select the Toggle Standard Profile icon in the toolbar. A check mark appears in the Standard
column in the Test Profiles List.
Tests contained in the standard profile are automatically programmed on every sample that has a sample ID
but does not have a test programmed through the LIS. There can be only one standard test profile on the sys-
tem.
Test Profiles List Toolbar

The Test Profiles List operations toolbar includes the following:
Add – Opens the Profile Definition screen where you can define a new test profile.
View – Opens the Profile Definition screen for the profile having focus2.
Delete – Deletes the selected profiles.
Toggle Standard Profile. Enables/disables the standard profile.
one object.

Chapter 4 – Setup
Test Profiles List Screen
Selection C olumn
N ame
Unique test profile name. Maximum 10 characters.
D escription
User-created description of the test profile. Maximum 50 characters
Standard
A check mark indicates the standard profile. Tests contained in the standard profile are automatically pro-
grammed on every sample that has a sample ID but does not have a test programmed through the LIS. There
can be only one standard test profile on the system. If the LIS orders a test that is contained in the standard
profile, the system does not run a duplicate test.
See Configuring the standard profile.
NOTE:
l The Available tests window contains only enabled test definitions.
l You cannot duplicate tests within a single profile.
l You cannot delete a test definition that is referenced in any test profile.
l You cannot disable a test definition that is referenced in any test profile.
See Also
l Test Definition

QC Profiles List
QC Profiles List
The QC Profiles List contains all QC profiles currently defined on the system.
Accessing the QC Profiles List

To access the QC Profiles List:
1. Select Setup > QC Profiles List in the menu bar.
2. To view a QC profile, double-click a profile in the table.
3. To add a new QC profile, click the Add icon in the toolbar.
5. Select the Previous Screen icon in the toolbar to return to the QC Profiles List.
QC Profiles List Toolbar

Add a new QC profile. Opens the Profile Definition screen.
View Profile Definition details. Opens the Profile Definition screen for the profile in focus.
Delete a Profile. Deletes the selected profiles.

Chapter 4 – Setup
QC Profiles List Column Descriptions
Selection C olumn
Click one or more rows to place check marks in this column, indicating selection of one or more QC profiles.
Maximum 10 characters.
N ame
Name of the QC profile.
D escription
User-created description of the QC profile. Maximum 50 characters.
The following requirements apply:
l Duplicate profile names are not allowed.
l The Available QCs List contains only enabled QC definitions. See QC List.
l The selected QCs list contains only QC definitions you selected from the available QCs list.
l You cannot duplicate QCs within a single profile.
l You cannot delete a QC definition that is referenced in any QC profile.
l You cannot disable a QC definition that is referenced in any QC Profile.
See Also
l Quality Controls
l QC Overview
l QC List
l QC Results List

Defining QC Profiles
A QC Profile is a group of QC tests under one heading or name that you can select to run without needing to
individually select each of the QC tests. The ACL TOP instrument is capable of storing up to 100 QC pro-
files, each containing up to 15 individual tests.
Creating a QC Profile
To create a QC Profile:
2. Select the Add icon in the toolbar, or select Actions > QC Profile > Add in the menu bar. The
QC Profile Definition screen appears. A maximum of 100 QC profiles may be defined.
3. Enter a unique name (maximum of 10 characters) and a description (maximum of 50 characters) in the
appropriate fields.
4. Select the tests in the Available QCs field to included in the new QC profile, and select the right
arrow to move them into the Selected QCs field.

Chapter 4 – Setup
Viewing a QC Profile
To view a QC profile:
2. In the QC Profiles List, do one of the following to open the QC Profile Definition screen:
l Double-click a profile.
l Select a profile and select the View icon in the toolbar.

l Select a profile and select Actions > Review > QC Profile Definition in the menu bar.
3. In the QC Profile Definition screen, the tests listed in the Selected QCs field are the tests in the QC
profile that has focus1 in the QC Profiles List.
Editing a QC Profile
To edit a QC profile:
1. Open a QC profile in the QC Profile Definition screen. See Viewing a QC profile.
2. Select tests in the Available QCs and Selected QCs fields, and use the arrow buttons to move them to
and from the Selected QCs field. The tests in the Selected QCs field are the tests that are included in
the QC profile after you save.
Deleting a QC Profile
To delete a QC profile:
2. Select one or more QC profiles in the QC Profiles List and select the Delete icon in the tool-
bar.
3. Click OK in the confirmation dialog box.

See Also
l Quality Controls
l QC Overview
l QC List
l QC Profiles List
l QC Results List

Chapter 4 – Setup
Reflex Rules
Reflex rules allow you to program and automatically execute a test generated by a condition of another test's
results. The ACL TOP instrument can store up to 100 reflex rules, each containing up to 10 conditions.
Creating a Reflex Rule

To create a reflex rule:
1. Select Setup > Reflex List in the menu bar.

3. In the Reflex Definition screen, enter a unique name for the reflex rule in the Rule name field. The
name can be 1-10 characters.
4. Enter a description of the rule in the Description field. The description can be 1-80 characters.
5. Click in the Test Code column, then select a test code in the drop down list.
6. Click in the Result Unit column, then select the result unit in the drop down list.
7. Click in the Rule column, then select a rule in the drop down list.
8. If the rule contains an operator (<, >, =), enter a numeric value for the rule in the Value column.
9. If multiple rules are used in the reflex test, select either the AND or OR operator from the Op. (oper-
ator) drop down list. This is available only if two or more rules are selected.
10. Use the arrow buttons to move one or more tests to execute in response to the reflex rule violation
from the Available window to the Selected window. You cannot select the same test code you
selected in the earlier step.
Viewing or Editing a Reflex Rule

To view or edit an existing reflex rule:
1. Select Setup > Reflex List in the menu bar.
2. Double-click a rule in the Reflex List to view the rule settings in the Reflex Definition screen.
3. Follow the steps in the Creating a Reflex Rule procedure to edit the rule.

Reflex Rules
Reflex List Operations Toolbar
Add Reflex Rule – Opens the Reflex Definition screen.
View Reflex Rule – Opens the Reflex Definition screen for the Reflex Rule having focus.
Delete Reflex Rule – Deletes the selected Reflex Rule.
Reflex List
The Reflex List screen contains a list of all reflex rules currently defined on the instrument.
Selection C olumn
Click in the column to select. Select one or more reflex rules to delete.
N ame
Name of the reflex rule. Must be a unique name with a maximum of ten characters.
D escription
Description of the reflex rule. Cannot exceed 80 characters.
NOTE: After a reflex triggers, the reflex test does not execute if it has already been performed on a
sample. For example, the FXIII Ag test is run and a reflex rule causes the FXIII High test to run. Later, FXIII
Ag is requested for the same sample again and again meets the criteria to reflex. The reflex test does not
execute because it has already been performed.

Chapter 4 – Setup
Reflex Definition Screen
Rule name
Name of the reflex rule. Enter a unique name with a maximum of 10 characters.
Description
Description of the reflex rule. Enter a description with a maximum of 80 characters.
Conditions
Test C ode
Unique identifier of a test in the reflex rule. Click in the table cell, then select a test code in the drop down
list.
R esult U nit
Test result unit for a test in the reflex rule. Click in the table cell, then select a result unit in the drop down
list.
R ule
List of rules to apply to the reflex rule. Click in the table cell, then select a rule in the drop down list.

Reflex Rules
Value
Numeric value to apply to the reflex rule. If the rule contains an operator (<, >, =), enter a numeric value in
this table cell.
Op.
Operator to use if multiple rules are used in the reflex test. Click in the table cell, then select the AND or OR
operator in the drop down list. This is available only if two or more rules are selected.
Tests to be executed
Use the arrow buttons to move the selected tests to execute in the reflex rule from the Available window to
the Selected window.
A vailable
List of available tests.
Selected
List of tests to run if the reflex rules trigger an event.
See Also
l Alternative Pre-Dilution

Chapter 4 – Setup
Auto-Validation Setup
Use the Auto-Validation Setup screen to configure the instrument to automatically validate test results based
on the criteria you select.
Configuring Auto-Validation
To configure auto-validation:
1. Select Setup > Auto Validation in the menu bar.
2. In the Auto Validation screen, select the Enable auto-validation option.
3. Select the Patient result, Parallelism result and/or Calibration result options to enable selection of
the auto-validation exception criteria in the Patient, Parallelism and Calibration columns. If you do
not select any of these options, auto-validation is performed for every test result.
4. Select the Auto-Validation Exception criteria in the Patient, Parallelism and/or Calibration columns.
Auto-validation of test results does not occur for the criteria you select.

Auto-Validation Setup screen
Enable auto-validation
Option to auto-validate test results. Enables the controls on this screen. Data reduction tests each mean result
against the established result range flags.
Patient result
Option to auto-validate patient test results. Enables the selection of exception criteria in the Patient column.
Parallelism result
Option to auto-validate parallelism test results. Enables the selection of exception criteria in the Parallelism
column.
C alibration result
Option to auto-validate calibration test results. Enables the selection of exception criteria in the Calibration
column.
Auto-Validation Exceptions
Auto-validation exceptions are organized by the following criteria:

Chapter 4 – Setup
Failures
Test failed – Option to block auto-validation when a test fails.
Errors
l DR error on measured results – Option to block auto-validation when a data reduction error occurs
on a measured result. Selecting this option automatically selects the following criteria:
o Results outside test range
o Results outside therapeutic range
o Results outside linear range
o Results outside normal range
l Max. difference on primary test result – Option to block auto-validation when the Max. difference
value for a test result exceeds the value defined in the respective test definition. See Result Unit Def-
inition.
l Parallelism error – Option to block auto-validation when any of the parallelism data reduction
parameters have been exceeded. (See Parallelism Setup - Data Reduction Tab.) Parallelism must be ena-
bled.
l QC errors – Option to block auto-validation when any QC rule has been violated, as defined in the
respective QC setup definition.
l Temperature error – Option to block auto-validation when the analyzer temperature drifts from nom-
inal during a test.
l Errors on test results – Option to block auto-validation when any error occurs on test results.
W arnings
l DR warning on measured results – Option to block auto-validation when a data reduction error
occurs on a measured result (as defined, and if enabled) in a test definition under Raw Data Checks,
Normalized Data Checks, or Primary/Secondary Algorithm. (See Data Reduction Parameters.)
l Parallelism warning – Option to block auto-validation when a parallelism error occurs on a par-
allelism result.
R esults outside range

These four options are automatically selected when the DR error on measured results option in the Errors
criteria group is selected. They can also can be selected independently.
l Results outside test range – Option to block auto-validation when test results are outside the test
range.
l Results outside therapeutic range – Option to block auto-validation when test results are outside the
therapeutic range.
l Results outside linear range – Option to block auto-validation when test results are outside the linear
range.
l Results outside normal range – Option to block auto-validation when test results are outside the nor-
mal range.

Expirations
l LAS Sample expired during processing – Option to block auto-validation when the LAS sample
expiration time has been exceeded before the Sample results are obtained.
l Material expiration – Option to block auto-validation when a material used for a specific test has
expired before the Sample results are obtained. The Enable lot management option must be selected.
See Material Definition – Lot Specific Information Tab.
l Material stability expired – Option to block auto-validation when a material used for a specific test
has exceeded the on-board stability value, as defined in the Material Definition before the Sample
results are obtained. The On-board stability tracking option must be selected. See Material Definition
– General Information Tab.
Overdues
l Calibration overdue – Option to block auto-validation when a calibration related to an ordered test
becomes overdue before the test results are final.
l Maintenance overdue – Option to block auto-validation when any maintenance operation becomes
overdue.
l NPP overdue – Option to block auto-validation when an NPP1 related to an ordered test becomes
overdue before the test results are final.
l QC overdue – Option to block auto-validation when a QC related to an ordered test becomes over-
due before the test results are final.

Chapter 4 – Setup
Revision History Report

Available only to IL personnel.

Importing and Exporting Definitions
Overview
The Import/Export feature allows you to transfer a copy of any or all of the following data:
l Materials
l Tests
l QCs
l Vials
l Profiles
o Test
o QC
l Reflex
l Sample display settings
l Programming window
o Tests
o Materials
l Maintenance activities
l Bar code definitions
l LIS definitions
l Global definitions
l Security definitions
l LAS definitions
l Report configuration
l Validation rules
Use the import/export function to transfer test and material definitions from one instrument to another. Data
transfer can occur between all ACL TOP Family instruments.
For example:
l From one ACL TOP 700 instrument to another ACL TOP 700 instrument
l From an ACL TOP 500 CTS instrument to an ACL TOP 700 instrument
NOTE: All ACL TOP models contain some unique Test, Material and QC definitions that are not
compatible with other ACL TOP models, and therefore cannot be imported/exported between instrument mod-
els.

Chapter 4 – Setup
Exporting Definitions
To export data from the Import/Export screen:

1. Select Setup > Import/Export to open the Import/Export screen.
2. Select the Export tab.
3. In the Destination file field enter a file name with extension .XML after the displayed path. Use the
Browse button to change the file path. The Export icon is enabled only for XML files, as
in the following example:
4. Select the tab that corresponds to type of data to export.

5. In the Available window, select one or more items to export. Use the Shift/CTRL keys to multi-select.
6. Select the upper right arrow to move selected items to the Selected definitions to Export window.
The system automatically moves other related definitions.
For example: If you select the PT-RP test on the Tests tab, all materials associated with the PT-RP test
are automatically moved to the Selected definitions to Export window on the Materials tab.
7. <Optional> Check the Select All option to move everything in the Available window to the Selected
definitions to Export window.
8. <Optional> Place a check mark in the box to the left of an item in the Selected definitions to Export
window to force that definition to be imported during a subsequent import process. A check mark
here prevents deselection of that definition when performing the subsequent import. All dependent

definitions are also be imported.
For example: If you select the PT-RP assay for forced subsequent import during the creation of the
export file, all materials required to perform the test (Factor Diluent, HemosIL Cal Plasma, PT Recom-
biPlastin, Clean B Diluted) are also imported. Materials that are not required to run the test (QC mate-
rials) are not imported. Enable the selection of dependencies on the Others tab. By default, the system
forces import of everything used in the exported definition.
9. To delete definitions, use the lower right arrow to move them to the Selected (definitions) to delete
window. The system does not automatically move related definitions. You must move related def-
initions manually. To force the deletion of a definition on import, check the item in the Selected to
Delete window.
10. Select the Export icon in the toolbar to move a copy of the definitions to the selected file loca-
tion.
Importing Definitions
NOTE: An import operation cannot be performed while the system status is BUSY or in a CON-
TROLLED STOP.
To import data:
1. Select Setup > Import/Export to open the Import/Export screen.
2. Select the Import tab.

Chapter 4 – Setup
3. In the Source Data area use the Browse button to locate the source file to import. Files for
import must have an .XML extension. After selecting the file, the definitions contained in the file
appear in the Available and Available Definitions Marked to be deleted windows in each tab of the
Import screen. Definitions selected for mandatory import or deletion are displayed in the Selected def-
initions to add/import and Selected definitions to delete windows, respectively.
4. Select the tab for the type of data you are importing.
5. Select one or more definitions in the Available window, and select the upper right arrow to move
them to the Selected definitions to add/import window. Use the Shift/CTRL keys to multi-select.
Select the Select All option to move everything to the Selected definitions to add/import window.
6. By default, all available definitions are selected for import. To deselect a definition for import, use the
left arrow to move it from the Selected definitions to add/import window to the Available window.
Select the Select All option to move everything from the Selected definitions to add/import window
to the Available window.
NOTE:
l Importing data overwrites all IL-Locked fields. It does not overwrite most user-defined
fields. An exception is user-defined fields in the QC definition. To avoid overwriting
QC definitions, move QC definitions from the Selected definitions to add/import win-
dow to the Available window before import.
l Importing items with check boxes is mandatory. Importing items without check boxes
is not mandatory. To avoid importing unchecked items, move them to the Available
window. To import non-mandatory items, move them to the Selected definitions to
add/import window.
7. Select the Import user defined fields option to import user-defined fields.
8. To delete definitions, use the lower right arrow to move them to the Selected (definitions) to delete
window. The system does not automatically move related definitions. You must move related def-
initions manually.
9. Select the Import icon to transfer the definitions to the instrument.
CAUTION:
l When you import results data from a calibration, the Result Correlation setup in Result Units is not
protected from editing. Changing the correlation factor or the offset for IL locked tests can com-
promise calibration results.
l After importing a test over an existing test in the database, you must recalibrate the imported test
before running any type of sample.
NOTE:
l A definition with a broken underline indicates the definition exists on the system, and will be over-
written during the import.

l If two materials or tests have different ID numbers but the same name, the system imports all the
parameters except the one with the duplicate name code. A message displays information about the
definition with the duplicate name code.
l When importing a maintenance activity, the Frequency field is overwritten if the imported activity is
more frequent than the one set by the system. Frequency is not overwritten if the imported activity is
less frequent than the one set by the system.
Field Descriptions
Major Version
Number assigned to the major version of the test parameters.
Minor Version
Two fields indicating the minor version of the test parameters.
Others Tab
Select the dependencies to force the instrument to import for each definition being imported. By default, the
instrument imports everything used in the definition. Dependencies imported include the following:
l Maintenance activities
l Barcode definitions
l LIS definitions
l Global definitions
l Security definitions
l LAS definitions
l Report configuration
l Validation rules
The settings in this tab are exportable to assist in the transfer of user-defined settings from one instrument to
another of the same model.

Chapter 4 – Setup
Global Definitions Setup

Global Definitions is the area of configuration that allows you to select options that define default values
used by the system when configuring other areas of the system.
Setting Up Global Definitions

To set up global definitions:
1. Make sure the instrument is in the READY state.
2. Select Setup > Global Definitions in the menu bar.
3. In the Global Definitions screen, configure the global parameters.
Global Definitions Setup Screen
Run
Patient Priority
Option to pipette all test requests for one patient sample before starting the next patient sample. For example,
if PT and APTT tests were ordered for four samples, the processing order would be:
Sample 1: PT
Sample 1: APTT

Sample 2: PT
Sample 2: APTT
Sample 3: PT
Sample 3: APTT
Sample 4: PT
Sample 4: APTT
Throughput
Option to schedule the test to run starting with the 8 tests that complete the quickest. Then the scheduler
processes the next 8 quickest tests, and so on. In the example used above the processing order would be:
Sample 1: PT
Sample 2: PT
Sample 3: PT
Sample 4: PT
Sample 1: APTT
Sample 2: APTT
Sample 3: APTT
Sample 4: APTT
A uto R un
Option to run tests automatically after a sample is PLACED.
The run starts automatically when all the following conditions are met:
l A sample is placed (sample status is PLACED).
l An enhanced clean is not currently required.
l Temperatures are not out of range.
l All ORUs are enabled.
The instrument monitors these conditions at 1 minute intervals. If the above conditions are not met, the instru-
ment retries autorun after each monitoring interval.
After Autorun starts, the instrument status remains BUSY until testing completes.
Test Definition Features
D isplay D erivative C urves

Option to enable/disable displaying the first and second derivative curves in the reaction graph on the Test
Details screen. In the Test Details screen you can toggle derivative curves on and off. This option defines the

Chapter 4 – Setup
default global setting.
Enable Global R erun

Option to enable/disable all rerun rules for all tests that have Rerun parameters defined and enabled.
Enable Global R eflex

Option to enable/disable all reflex rules for all tests that have Reflex parameters defined and enabled.
Sample Life
Sample life specifies a time frame, in days or hours, that is used to determine whether new test requests, com-
ing from the LIS or programmed by you, are assigned to a sample ID that is already in the system. In other
words, if a sample/test request is received by the ACL TOP within the time specified in the sample life field,
and the same sample/test request (with identical patient demographics) is already in the system, the new test
request is appended to the sample already in the system.
For example, if the sample life field is set to 24 hours and a sample ID 123 with test APTT (having blank
patient demographics) is received by the TOP at 10:00 a.m. Oct 1, then another sample ID 123 with test
APTT (having blank patient demographics) is received by the system at 8:00 a.m. Oct. 2, the second APTT
test is appended to the first sample ID 123. In this example, the results for the two tests are displayed as fol-
lows:
Sample ID Test
123 APTT
If a sample ID 123 with test APTT (having blank patient demographics) is received by the TOP at 10:00 a.m.
Oct 1, then another sample ID 123 with test APTT (having blank patient demographics) is received by the
system at 11:00 a.m. Oct. 2, the second sample ID/APTT test is run as a completely separate test from the first
sample ID. In this example, the results for the two tests are displayed as follows:
Sample ID Test
123 APTT
.
Sample ID Test
123 APTT
If sample life is disabled, sample IDs are reused. The range is 1-99, the unit is hours or days. The default is 24
hours.
Default File Path

Location where data logs are stored, if enabled. The system must be configured by an IL representative to
save data reduction reports. To change the default file path, select the browse button and enter a new loca-
tion.
Test Mode Extensions
Extended A cquisition Mode Extension

Extension added to the test code for tests run in extended acquisition mode. Any keyboard character may be
used. The default value is E.
Parallelism Mode Extension

Extension added to the test code for parallelism tests. Any keyboard character may be used. The default
value is P.
D iluted Mode Extension

Extension added to the test code for diluted tests. Any keyboard character may be used. The default value is
D.
Editing Options
Enable K eypad
Option for a numeric keypad to popup anytime you click in a field that contains a numeric value. Disabled
by default.
Enable K eypad for Sample ID

Option for a numeric keypad to popup anytime you click in a sample ID field that contains a numeric value.
Disabled by default.
Sample/Reagent Probe Dilution Parameters
Max. Syringe Volume

Maximum volume of fluid able to be aspirated or dispensed. Limited by the physical characteristics of the
syringe pump. The default value is 250 μL.
Min. Syringe Volume

Minimum volume of fluid able to be aspirated or dispensed accurately. Limited by the performance char-
acteristics of the syringe pump. The default value is 4 μL.

Chapter 4 – Setup
Max. C onsecutive D ispensations

Number of dispenses of the same material that can be injected into the same cuvette well without rinsing
when preparing dilutions. The default value is 3.
Cuvette Dilution Parameters
C uvette Overflow Volume

Maximum volume capacity of a cuvette well. The default value is 600 μL.
C uvette B lind Volume

Volume of fluid, in microliters, that cannot be removed from the cuvette well by a probe aspiration. The
default value is 65 μL.
Min. C uvette Volume for Mix

Minimum volume of fluid, in microliters, required to be present in a cuvette well in order to mix the cuvette
well contents. The default value is 100 μL.
Min. C uvette Volume for Test

Minimum volume of fluid, in microliters, required to be present in a cuvette well before it can be sent to the
optical reading unit (ORU). The default value is 150 μL.
Max. C uvettes per D ilution

Maximum number of cuvettes to use when making dilutions. Select a number between 1 and 8.
CTS Parameters
Enable Piercing Mode

Option to enable cap piercing on the ACL TOP CTS instrument. Cap piercing is required when running tests
on closed tube samples. The default security access for this option is ILService or higher. This option enables
the Low-Fill Tubes Handling option.
Low-Fill Tubes H andling

Select the Enable Lower z-depth option to enable the ACL TOP CTS instrument to run tests on low fill
closed tube samples.
This option addresses sample tube types where a small fill volume (e.g. 1.8 mL) is paired with a tube inner
diameter typical of tubes designed to accommodate larger fill volumes (e.g. 2.7 mL). In these tubes, the
plasma fill line sits very low (near the bottom of the tube, and far from the tube cap), at a distance that is
barely reachable by the sample probe. Contact Service to enable this option.
System Identification
Serial N o.
AM serial number identifier.

Model
Type of configuration that defines the instrument. For example:
l ACL TOP 300 CTS
l ACL TOP 500 CTS
l ACL TOP 700 (includes ACL TOP Base)
l ACL TOP 700 CTS (includes ACL TOP CTS)
l TOP 700 LAS
System Capacities
Patient Samples
You can configure up to 20,000. You are prompted to confirm if the change causes a large amount of data to
be deleted.
QC Jobs
You can configure up to 20,000. You are prompted to confirm if the change causes a large amount of data to
be deleted.

Chapter 4 – Setup
Bar Code Definitions Setup
Configuring Bar Code Reading

To configure the bar code reading in the Sample and Reagent Areas:
1. Select Setup > Bar Code Definitions in the menu bar.
2. Configure the bar code settings in the Bar Code Definitions screen.
Bar Code Definitions screen
Enable Reagent Area Bar Code Reading

Option to enable the reading of bar code labels on the reagent bottles placed on racks in the Reagent Area.
When this option is disabled, the instrument does not read the bar code labels on the bottles it detects in the
reagent racks.
NOTE: When this option is disabled, the materials on the rack must be manually defined. Each
instance of an unknown reagent in a rack position triggers an alarm code 3004 error when reagent racks are
inserted into the instrument.
l Alarm 3004
Non-identified Material in rack <rack ID> position <rack position #>, track # <rack track #>.

Bar Code Definitions Setup
Enable Sample Area Bar Code Reading

Option to enable the reading of bar code labels on the sample cups and tubes placed on racks in the Sample
Area. When this option is disabled, the instrument does not read the bar code labels on the sample cups and
tubes it detects in the sample racks.
Available Bar Code Formats

Enables the following formats for selection:
C ode 128
Format used for all reagent bar codes and for sample and reagent rack information bar codes. It is always ena-
bled.
Interleaved 2 of 5
NOTE:
l This value must be set to 6, 8, 10, 12, 14 or 16 characters (minimum 6 characters, maximum 16, even
number of digits).
l When an odd number of barcode digits is configured, the system appends a zero to the beginning
when the label is scanned to convert the number of digits to an even number.
l The Checksum option adds a character to the barcode value. When using the Checksum option, set
the Max. Number of digits value to 14 or fewer.
l For safety reasons set both the minimum number of digits and the maximum number of digits to your
commonly used size. For example, if you commonly use a 12 digit bar code, set both the Min. and
Max. Number of digits fields to 12.
Enable C ode 39
The following options are available:
l Enable Checksum – Option to use a checksum. Select the checksum type from the drop down list.
l Enable Large Intercharacter Gap – Option to use a Large Intercharacter Gap. Enables the scanner to
read symbols with gaps between the bar code characters that exceed three times the narrow element
width. This is useful for reading symbols that are printed out of specification.
Enable C odabar N W (7) Japan

The following options are available:
l Enable Checksum – Option to use a checksum. Select the checksum type from the drop down list.
l Enable Large Intercharacter Gap – Option to use a Large Intercharacter Gap. Enables the scanner to
read symbols with gaps between the bar code characters that exceed three times the narrow element
width. This is useful for reading symbols that are printed out of specification.
NOTE: An alarm is triggered when the bar code reader encounters a label longer than 16 characters.

Chapter 4 – Setup
See Also
l Material Identification

Bar Code Label Placement
Bar Code Label Placement

To assure accurate bar code scanning, do not place the label too low or too high on the tube. Use the fol-
lowing diagram to determine correct placement of the label.
NOTE: Place the label inside the Symbol Placement Zone.
See Also
l Bar Code Definitions Setup
l Bar Code Reader

Chapter 4 – Setup
LIS Configuration
Overview
The ACL TOP instrument can interface to an LIS (Laboratory Information System). There are two types of
communication between the ACL TOP instrument and the LIS (host). The communication from the LIS to the
ACL TOP instrument is known as Host downloads and the communication from the ACL TOP instrument to
the LIS is known as Host uploads.
In a host downloading process, the information that travels from the LIS to the ACL TOP instrument is a set
of test orders. A test order can be described as a test request to be performed on a sample. In a host uploading
process, the information that travels from the ACL TOP instrument to the LIS is a set of test results. A test
result can be briefly described as the numeric analytical values (measured or calculated) and/or associated
error status, flags, and warnings, produced by the execution of the test.
NOTE: The ACL TOP instrument does not run duplicate tests, whether ordered through the LIS or
ordered manually. Only one test is performed per test code, per sample. To run duplicate tests on a sample,
you must either 1) configure the test definition to run a replicate; or 2) wait until a test has generated test
results.
You configure the method of communication with the LIS on the LIS setup screen.
Configuring Communication with an LIS
NOTE: An LIS Administrator should supervise LIS configuration.

To configure communication with an LIS:
1. Select Setup > LIS > Communications in the menu bar.
2. In the LIS Setup screen, complete the information on the Host Communications Configuration,
ASTM-1394 Configuration, and Communications Configuration tabs according to your LIS require-
ments.
Performing a Manual LIS Query

To manually request test orders from the LIS:
1. Select Analysis > Sample List in the menu bar.
2. In the Sample List, select Actions > Results > Download Tests Order in the menu bar.
Alternatively, see Programming Non-Bar Coded Samples After Inserting the Rack, Using an LIS without Host
Query Enabled.

LIS Configuration
Host Communications Configuration Tab
Use this tab to enable the ACL TOP instrument to work with an LIS and configure the following modes and
identifiers.
Enable Host Communication

Option to enable the ACL TOP instrument to work with an LIS system.
Host Configuration
Instrument ID
ID of the ACL TOP instrument to send and receive messages.
H ost ID
ID of the LIS host to send and receive messages.
Futura C ompatible Protocol

Option to set the ACL TOP instrument communications protocol to be compatible with LIS drivers devel-
oped for communications with the ACL Futura or the ACL Advance. This protocol is not fully ASTM-1394

Chapter 4 – Setup
compatible and has modifications that make it unique. If you select this protocol, the full ASTM-1394 Com-
patible Mode is automatically deselected.
If you select the Futura Compatible Protocol, only Upload Quality Controls and Trace communications pro-
tocols can be selected.
Full A STM-1394 C ompatible Mode (aka TOP-C ompatible mode)

Option to set the ACL TOP instrument communications protocol to be compatible with the LIS drivers devel-
oped for ACL TOP instrument communications that are fully ASTM-1394 compatible. If you select this pro-
tocol, the Futura Compatible Protocol is automatically deselected.
If you select Full ASTM-1394 Compatible Mode, the following four LIS options can be selected:
l Use internal instrument sample ID – Option to provide the LIS with the sample ID assigned by the
system.
l Upload quality controls – Option to upload quality control results to the LIS.
l Report errors to host – Option to report any LIS communications errors it encounters to the LIS.
l Trace communications protocols – Option to add trace information to the Operating System Event
Log.
Automatic Host Operation
H ost D ownloading
The following modes are configurable.
l Automatic Downloading – Option to perform an automatic download request each minute.
l Host Query – Option to query the LIS for test requests after a sample is placed on the instrument.
H ost U ploading
Selecting the Enable automatic uploading option enables you to select one of the following Automatic
patient uploading modes:
l Upload results per test – Option to upload each test result individually as the result is available.
l Upload results per sample – Option to upload all results for a specific sample ID.
Storage
When the laboratory LIS communication status is Disconnected, and ACL TOP LIS communications are ena-
bled, the instrument stores up to a maximum of 7200 messages.
R eset button
Resets the contents of storage so that messages pending to be uploaded are not sent when connections are
reestablished.

LIS Configuration
ASTM-1394 Configuration Tab
Use this tab to configure LIS protocol delimiters. The delimiters cannot be used more than once. Duplicate
delimiters are not ASTM compatible.
Field D elimiter
List of characters to use to delimit (or separate) consecutive fields. Select one from the list.
R epeat D elimiter
List of characters to use to separate several occurrences of a given field. Select one from the list.
C omponent D elimiter
List of characters to use to differentiate several parts within a given field. Select one from the list.
Escape D elimiter
List of characters to use to signal special uses of several characters. Select one from the list.
C ode pages
Select the appropriate code page set (for character encoding) from the list.

Chapter 4 – Setup
Communications Configuration Tab
Use this tab to configure either Serial Port LIS communications or Network LIS communications protocol.
Serial
Port C onfiguration
Only the COM port can be set. The selections are from a drop down list that contains COM1, COM2, COM3
or COM4.
NOTE: All the other RS232 configuration parameters, such as baud rate, parity, stop bits, etc., can be
configured through the Windows control panel and are not part of the ACL TOP instrument application.
Select the appropriate COM port from the drop down list.
Network
If you select Network configuration, the setting of the Network TCP/IP configuration can be performed.
TC P/IP C onfiguration
If the connection mode is Server, the IP address is not editable. It is the responsibility of the Host to know
the TOP's IP address.
If the connection mode is Client, enter the IP address and Port for the LIS host.
See Also
l Sender List

Sender List
Sender List
The Sender represents the location from which a sample has been received. The Sender List displays a sum-
mary of currently defined senders.
Accessing the Sender List

To access the Sender List:
1. Select Setup > LIS > Sender List.
2. To add a sender to the list, select the Add icon in the toolbar.
3. Fill out the form fields.
5. To delete a sender in the list, select1 the sender in the Sender List and select the Delete icon in
the toolbar. Confirm the deletion.
Sender List
Each sender is identified by the following information:
l Code – Unique identifier for sender
l Name
l Department
l Street
l City
l State/Country
l Contact
l Phone
See Also
l LIS Configuration
one object.

Chapter 4 – Setup
LAS Overview
Definition
Laboratory automation systems are large automated laboratories that use a track to route primary sample tubes
requiring analysis through pre-analytical, analytical and post-analytical stations positioned throughout the
track. See Sample Containers and Adapters for a list of approved primary sample containers for use on the
LAS track.
The ACL TOP 700 LAS is a laboratory track automation-compatible hemostasis analyzer with the same fea-
tures and functionality as the ACL TOP. It is designed for point-of-reference sampling following standards ref-
erenced in the following CLSI documents:
l AUTO1: Specimen Container/Specimen Carrier
l AUTO2: Bar Codes for Specimen Container Identification
l AUTO3: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and
Information Systems
l AUTO4: Systems Operational Requirements, Characteristics, and Information Elements
l AUTO5: Electromechanical Interfaces (from the automated track positioned adjacent to the instru-
ment, or sampling from samples manually loaded at the front of the analyzer)
Sample Workflow
Sampling from the LAS track is performed by the LAS sampling module located on the left side of the instru-
ment. The LAS module consists of an LAS sampling arm with dedicated sample probe syringe, vial position
and LAS cuvette holding area.
The LAS area includes an enhanced clean station with an access door. The LAS arm accesses a bottle of
clean material in the clean station to perform daily enhanced cleans. The access door allows you to place and
remove clean material. See Enhanced Clean for LAS Probe.
NOTE:
l Do not place any items on the LAS arm cover.
l If the door on the LAS sampling module is opened when it is unsafe, the instrument performs an emer-
gency stop. If the door is opened during power-up, the system stays in Power Up status until the door
is closed.
l Capped, unspun samples must be spun and uncapped by the LAS system before moving them to the
analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot
When the LAS automation track is enabled in the LAS Configuration screen and the LAS automation track is
functioning, primary sample tubes are scanned at the LAS query point before entering the LAS sample tube
queue. If the LAS Manager software determines that the sample requires testing by the TOP LAS analyzer,
the LAS track diverts primary sample tube from the main track to the sample tube queue. Primary sample
tubes that do not require testing bypass the TOP LAS and remain on the main LAS automation track.

LAS Overview
Sample aliquots are drawn from the primary sample tube and placed on-board in a cuvette cell. The maximum
volume for an aliquot from the LAS track is 600 μL. The maximum sample volume that can be removed from
the sample tube is 1200 μL.
The aspirated sample remains accessible in the LAS holding area for rerun and reflex tests until the sample
expiration time has elapsed.
Auto Run
When the LAS Track option is enabled, Auto Run is automatically enabled and cannot be disabled. Excep-
tion: LAS Controlled Stop.
The instrument begins processing tests automatically after all of the following conditions are met:
l A sample is placed (sample status is PLACED).
l No enhanced clean is currently required.
l Temperatures are not out of range.
l All ORUs are enabled.
l Test is feasible (reagents on-board).
The instrument monitors these conditions at one minute intervals. If a condition is not met, it tries to initiate
Auto Run after each monitoring interval.
After Autorun starts, the instrument status remain Busy until testing is complete.
Prioritization of Samples
You can place samples in the front of the instrument at any time using the sample racks in the sample tracks.
Sample tracks S1-S3 are blocked and cannot accept sample racks.
Run priority is based on sample status and position placed on the instrument according to the following:

Chapter 4 – Setup
l Highest Priority – STAT samples front-loaded in sample racks

l Middle Priority – Samples aspirated from the LAS track
l Lowest Priority – Non-priority samples front-loaded in sample racks
NOTE:
l Samples aspirated from the LAS track do not receive priority status. The fastest way to process a test
is to assign priority status (STAT) and front load the sample on a sample rack.
l Test orders for samples provided by the LAS track are received from the LIS. Manually entered test
requests can only run on samples that are manually loaded in the sample area.
Communication
The LAS Manager runs on an external computer and manages the primary sample tubes traveling on an LAS
automation track.
Communication between the LAS instrument and the LAS track is through an embedded interface module
(IM) that is configured in the LAS Configuration screen.
Hazards and Warnings
CAUTION Biohazard: Check the underside of the instrument and table on that it sits for
leaks. Clean and disinfect any spills discovered. Report leaks to Service personnel for repair.
NOTE: LAS alarms are displayed in the General Log as well as in External Communications Alarms
in the Status Bar at the bottom of the screen. See External Communications Alarms.
CAUTION: To avoid contamination, Instrumentation Laboratory strongly recommends against using

the ACL TOP instrument to perform analysis on Hepabsorb samples.
LAS Terminology
See Terminology.
See Also
l LAS Configuration
l LAS Cuvette Holding Area

LAS Configuration
LAS Configuration
The LAS Configuration screen is used to configure the ACL TOP instrument for operation and network com-
munication. Most of the fields on the three tabs contain read-only values defined by IL and the system
installer. You can enable or disable the Laboratory Automation System (LAS) on the LAS Configuration tab.
When LAS is enabled, communications with the LAS track are initiated.
Accessing the LAS Configuration screen

To access the LAS Configuration screen:
l Select Setup > LAS Configuration in the menu bar.
LAS Configuration tab
The parameters defined in the LAS Configuration tab do not affect the following configurations defined else-
where:
l Sample and reagent dilution parameters defined in Global Definitions.
l Load cycle parameters defined in Test Definitions.
Enable LAS Track

Option to enable the Laboratory Automation System (LAS).
If unchecked, the connection to the LAS track is disabled and the LAS arm moves to the rinse station. When
disabled the LAS track remains available for Diagnostics and Maintenance.

Chapter 4 – Setup
NOTE:
l Capped, unspun samples must be spun and uncapped by the LAS system before moving them to the
analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot
l If the instrument detects insufficient volume of clean material for the LAS probe to perform a required
clean cycle during testing, it performs an emergency stop to prevent contamination.
C onnection
The connection settings are read-only, configured at initial set up, and should not be altered.
LAS Parameters
Most of the fields on this tab are for test developers only.
# Slots for dilution preparation

Number of slots reserved for calibrations and sample pre-dilutions. You can select values from 2-8. The
default value is 2 which ensures maximum throughput. Increasing the number of preparation cuvettes in this
field lowers the number of slots available for cuvette strips on-board, and lowers system throughput. See LAS
Cuvette Holding Area.
NOTE:
l The system status must be Ready to adjust this setting.
l When the LAS arm is disabled, the TOP instrument ignores the value in this field and operates by
front loading with 8 slots for predilutions.
l When the LAS arm is re-enabled (in this screen or in Diagnostics), this field is enabled and the instru-
ment sets the number of predilutions to the value in this field.
Adjustments for Calibration
You may need to adjust this setting during calibration. If the current setting is insufficient to run calibration,
an error message states: Number of preparation cuvette slots is insufficient to execute a calibration or par-
allelism job.
When performing multiple calibrations, IL recommends setting this value to 8 for maximum efficiency.
When performing a single calibration, you may run normal samples, but throughput is reduced. For this rea-
son, IL recommends running calibrations independently of sample processing. When calibrating a single test,
the required setting is 3-8 slots.

LAS Configuration
When calibration is complete reset this value to 2 for maximum throughput. If the value is not reset to 2,
throughput is reduced, and a back up of primary sample tubes may occur in the LAS track sample queue.
Sample aspiration time

Maximum time a sample tube sits in the LAS Sample queue on the LAS track before the system removes it
from the aspiration position. The default value is 15 minutes.
The cause for delay may include the following:
l The LAS system performs a controlled stop.
l Maintenance is performed.
l The instrument is processing a large number of samples.
NOTE:
l You can adjust the sample aspiration time to avoid sample tubes getting stuck for a long time. The
aspiration time starts when the instrument accepts a tube from the LAS track. When the aspiration
time expires, the tube is released without aspiration. The acceptable range for this value is 5-99 min-
utes or 1-99 hours.
l If it becomes necessary to adjust this setting, take optimization measures to meet your turnaround
requirements. Consider load balancing adjustments using existing TOP 700 LAS units connected to
the LAS track, or connect additional TOP 700 LAS units.
Sample expiration time

This value cannot be modified.
Time used to determine when a sample that has been aliquotted from the LAS track to a cuvette in the hold-
ing area moves to waste. The LAS sample expiration time starts when the LAS sample is fully aliquoted into
the first cuvette cell in the aliquoting area. If the time expires while a test is in the active state, the test
executes and is flagged.

Chapter 4 – Setup
Tests (including reflex and reruns) become not feasible when the LAS Sample expiration time has elapsed. If
a test has not entered the active state when the Sample expiration time elapses, the test does not execute,
and the sample must be reinserted into the instrument.
LAS Interface Module Configuration tab
Enable Interface Module

This option is set by the system installer and cannot be modified. The TCP/IP configuration settings apply to
the interface module computer.
LAS Tube Types tab
This tab is a read only reference for the system installer.
See Also
l LAS Overview

System Security
System Security
The ACL TOP instrument user interface has four security levels. These are listed below from highest to low-
est access level for: 1) IL locked tests and materials; and 2) non-IL tests and materials:
l Administrator
l Supervisor
l Senior operator
l Operator
Setting up your system security is a three-step process. You need to:
1. Decide the tasks that you want each security level to be able to perform.
2. Configure the Software Access screen accordingly.
3. Define the users.
NOTE:
l Instrumentation Laboratory recommends that certain critical operations (for example, ISI value, cal-
ibrator values, etc.) be reserved for lab supervisor or lab administrator roles.
l Only the lab administrator should have access to Diagnostics.
l You cannot modify or delete IL pre-defined users/levels.
See Also
l Software Access screen

Chapter 4 – Setup
User Security List

The User Security List screen lists the users configured on the system.
Accessing the User Security List

To access the User Security List:
1. Select Setup > Security > User Security List in the menu bar to open the User Security List.
2. See Adding and Editing Users.
User Security List screen
Depending on your security level, you can add a new user, delete a user, or edit an existing user by clicking
the appropriate icons in the toolbar.
Selection C olumn
Locked Status C olumn

A check mark indicates the user ID is locked, and cannot log into the ACL TOP application. A user ID
becomes locked when any of the following occurs:
l The account expires.
l After three unsuccessful login attempts.
l A system administrator selects the User Locked option for a user in the User Security screen.
Only a system administrator can unlock an account.
See Also
l System Security

Adding and Editing Users

Only users with Supervisor or Administrator access rights can add, delete or modify users (user names). You
can define up to a maximum of 100 users.
The Supervisor and Administrator level can delete all users except the last Administrator.
The current user cannot delete his/her own entry in the User Security List, and cannot delete users with a
higher level of access than his/her own.
Adding a New User

To add a new user:

3. In the User security screen, enter a unique user name in the Log on name field.
4. Enter the new user’s first name and last name in the appropriate fields.
5. Select a user security level in the Security level drop down list.
6. <Optional> Enter a comment in the Comments field.
7. Enter the login password in the Password field.
8. Reenter the password in the Confirm Password field.
9. <Optional> Select the Allow expiration option and configure the Valid period and Warning period
as necessary.
10. <Optional> Select the User Locked option lock a user out of the system.
12. Select the Previous Screen icon in the toolbar to return to the User Security List.
13. The new user appears in the User Security List.

Chapter 4 – Setup
Unlocking a User
To unlock a user:
3. Select1 the user in the User Security List.
4. Select the User Definition icon in the toolbar.

5. In the User security screen, remove the check mark in the User Locked setting.
Editing a User
To edit a user:
3. Select2 the user in the User Security List.
4. Select the User Definition icon in the toolbar.

5. In the User security screen, make the necessary edits.
one object.
one object.

Deleting a User
To delete a user:
3. Select1 one or more users in the User Security List.

5. Confirm the deletion.
one object.

Chapter 4 – Setup
User Security Screen
User
Log on name
Unique user name. Used to log onto the ACL TOP instrument. Must be 1-20 case-sensitive characters.
First name
User’s first name (maximum 20 characters).
Last name
User’s last name (maximum 20 characters).
Security level
List of user security levels. Options are Administrator, Supervisor, Senior operator, and Operator.
C omment
Enter a comment with a maximum 80 characters.

Password
Password an d C onfirm password

User's login password (maximum 14 case-sensitive characters).
A llow expiration
Option to allow the password to expire after a configured number of days. If this option is not selected, the
password never expires. If selected, the following fields are enabled:
l Valid period – The period a password remains valid, after which the password becomes invalid.
Options are 1-365 days.
l Warning period – The period of time before password expiration when a system generated warning is
issued to the user. Options are 1-30 days.
Last modification
Date and time the user configuration was last changed.
U ser Locked
Option to lock a user out of the system. A check mark indicates the user is locked out of the system. A user
becomes locked when any of the following occurs:
l The account expires.
l After three unsuccessful login attempts.
l A system administrator selects this option.
See Unlocking a user.
See Also
l System Security

Chapter 4 – Setup
Software Access Screen

The Software Access screen contains a table of operations that can be performed on the ACL TOP instrument,
and the user access level required to perform them. Any user can view the Software Access screen.
Accessing the Software Access Screen

To open the Software Access screen:
1. Select Setup > Security > Software Access Screen in the menu bar.
2. Click the expand/collapse icon in the left column to show and hide additional rows for a screen.
3. To update user access levels, click an entry in the Access Level column and select a new access level
in the drop down list.
NOTE: You can edit the Software Access screen only if you are logged on with the appropriate
access rights. The lab administrator is always allowed to edit this screen.
See Also

Formatting Reports
Formatting Reports
Configuring Reports
To configure reports:
1. Select Setup > Reports in the menu bar.
2. Configure settings in the Report Configuration dialog box in the following tabs. Click a link for
details:
l Laboratory Header
l Demographic
l Footer
l AutoPrint Setup
3. To edit a table cell on the Laboratory Header and Footer tabs, double-click the cell and begin typ-
ing.
4. Select OK.
NOTE: Patient results and calibration results must be validated before printing. See Reviewing Test
Results and Calibration Details.

Chapter 4 – Setup
Laboratory Header Tab
This section is used to identify the laboratory that performed the analysis.
Alignment
Select one of the following options:
l Left – Left justifies the entire header at the top of the report.
l Middle – Centers the entire header at the top of the report.
l Right – Right justifies the entire header at the top of the report.
Column Headings
Field N ame
User-defined text field. The value entered identifies the data type to display in the report header. For exam-
ple: Laboratory. Maximum 15 characters. The actual text in this column does not appear in the report header.
Field Value
Enter the text to display in the report header. This text corresponds to the Field Name cell to the left. For
example: Hemostasis Lab
NOTE:
l Defining a report header is optional.
l If you define a field name, the Field Value cell to the right of it must have an entry. For example, to
display the name of your laboratory, double-click the first empty cell in the Field Name column and
type Laboratory. Then double-click the Field Value cell to its right and type in your laboratory
name. The text in the Field Value column appears in the header of each report.
l If you leave a Field Name/Field Value pair empty, a blank line appears at that location in the header.

Formatting Reports
l The maximum number of lines in a report header is 20, including blank lines. Unused Field
Name/Field Value pairs beneath the last pair that you define are ignored. They do not produce blank
lines.
l Click a column heading to sort up or down.
Demographic Tab
Check or uncheck the data to appear on the Patient Report and Sample Results Report.
Footer Tab
This data appears on the report footer. Configuring this tab is similar to configuring the Laboratory Header
tab.

Chapter 4 – Setup
AutoPrint Setup Tab
You can autoprint patient samples by sample, test or rack. Printing starts when one of the following occurs:
l As soon as the configured number of samples or tests completes.
l When the rack, if selected, is completed.
l When the configured number of minutes has elapsed.
Printing does not occur while the AM1 is Busy or in a Controlled Stop.
If you select autoprint By sample, all unprinted tests for a specific sample are printed. If all tests for a given
sample have already printed, auto print is not initiated for that sample.
If you select autoprint By test, completed tests that have not yet printed will autoprint.
If you select auto print By rack, all programmed tests of the selected test types are printed when the sample
track status for that rack changes from In use to Present or Empty.
NOTE: If autoprint is enabled for patient samples, a page is used for each individual sample or test
(depending on the mode enabled).
See Also
l Sample List Area

Display Overview
Display Overview
You can configure the display settings for the Sample List, the Test Programming window, and the Material
Programming window:
To configure display settings:
1. Select Setup > Display in the menu bar.
2. In the Display submenu, select one options:
l Sample List Display Settings

See Also
l Sample List Area

Chapter 4 – Setup

See Configuring Sample List Display Settings in Sample List.

Test Programming Window
Test Programming Window

Use the Test Programming window to do the following:
l Make various tests and profiles accessible for programming in the Sample Details screen.
l Add and remove test orders to and from a sample rack position on the Rack Details screen in the sam-
ple area.
Configuring the Test/Profiles Programming Window

To configure the Test/Profiles Programming Window:
1. Select Setup > Display > Test Programming Window in the menu bar. The Program Tests and Pro-
files Placement Window first opens with blank programmable buttons.
2. To create a new tab, select the Add Tab button. In the Program Tab Name dialog box, enter a unique
tab name with a maximum 16 characters, and select OK. The new tab is added to the right of the cur-
rently selected tab. Each tab contains twelve test or profile buttons. You can create up to 30 tabs.
3. To sort tabs, drag and drop tabs one at a time.
4. To remove a tab, select the tab and click the Remove Tab button. Confirm the deletion.
5. To program a button, drag a test or profile from the Available tests or Available profiles list to a
blank button on the tab. The test or profile name appears on the button, and the material is removed
from the respective list (for that tab only).
6. To remove a test or profile, drag the test or profile name from the button to the respective list. The
test or profile name is removed from the button and added to the respective list.
7. Select OK to save the configuration.
NOTE: Test and profile names can be added to only one button per tab, but can be added to multiple
tabs.
See Also
l Sample Rack Details
l Sample List Area
l Sample Details

Chapter 4 – Setup
Material Programming Window

Use the Material Programming Window to do the following:
l Add or remove materials used for testing samples, QC, calibration, etc.
l Add or remove materials to or from a reagent or diluent rack position on the Rack Details screen in
the Reagent and Diluent Areas.
Configuring the Material Programming Window

To configure program materials:
1. Select Setup > Display > Material Programming Window in the menu bar. The Program Materials
Placement Window first opens with blank programmable buttons.
2. If the programming controls do not appear in the Program Materials Placement Window, select the
Show Programming Controls button to display them. Select the Hide Programming Con-
trols button to toggle these controls out of view.

3. To create a new tab, select the Add Tab button. In the Program Tab Name dialog box, enter a unique
tab name with a maximum 16 characters, and select OK. The new tab is added to the right of the cur-
rently selected tab. Each tab contains twelve material buttons. You can create up to 30 tabs.
4. To sort tabs, drag and drop tabs one at a time.
5. To remove a tab, select the tab and click the Remove Tab button. Confirm the deletion.
6. To program a button, drag a material from the Available materials list to a blank button on the tab.
The material name appears on the button, and the material is removed from the Available materials
list (for that tab only).
7. To remove a material, drag the material name from the button to the Available materials list. The mate-
rial name is removed from the button and added to the Available materials list.
NOTE: Material names can be added to only one button per tab, but can be added to multiple tabs.

Material Programming Window
See Also
l Reagent Area
l Material List

Chapter 4 – Setup
Setup Language
To select the language to use on the ACL TOP instrument:
1. Select Setup > Language to open the list of available languages.
2. Select a language to use on the instrument.
NOTE: You must install the language files for this option to be available. Contact Service.

CHAPTER 5 Preparing the System
CHAPTER 5
PREPARING THE SYSTEM
Additional Preparation
The system can stay on 24 hours a day. Automatic maintenance procedures such as fluidic priming cycles
and routine cleaning of the probes ensure the system is ready for analysis at any time. If the system stays on,
there is no need to perform any startup procedure before operating the system.
If the system is turned off, follow the Starting the Instrument instructions to start the system.
In addition, the following may require some preparation:
l Bar Code Reader
l 2D Bar Code Scanner
l Reaction Cuvettes
l Rinse Fluid
l Clean Fluid
l Fluid Waste
l Reagents
l Calibrators and NPP
l Quality Controls
l Sample Containers and Adapters
l Diluents
l Restriction Map
l Sample Area
l Reagent Area
l Diluent Area
l Test Feasibility
See Also
l Managing Materials

Chapter 5 – Preparing the System
Material Identification
To assure automatic material identification, make sure the bottle bar code labels are properly aligned in the
rack before placing them on the instrument. See Bar Code Label Placement.
An active material is defined as one that is placed and required to complete an ACTIVE test.
Manually Identifying Offline Rack Material

To manually identify offline rack material:
1. Select the menu option Analysis > <material area> (Diluent or Reagent Area).
2. Double-click a position on the offline rack (located on the left hand side of the screen) to display the
Rack Details screen.
3. Select the position where the material is located.
4. Select the Add/Remove Material icon in the toolbar, or select the ellipsis next to the
Material name field.
5. Select the material from the Materials window.
6. Select the Insert Rack icon from the toolbar.

7. Insert the rack.
NOTE:
l If you manually identify a material placed on the offline rack (sample, diluent, or reagent) and a tube
or bottle with a bar code label is on the same rack, the system attempts to match the information man-
ually entered with the bar code label. If it does not match, the system displays an error message.
l If you manually identify the presence of a material (tube, bottle, or sample cup) placed on the offline
rack (sample, diluent or reagent rack) and upon insertion, the bar code reader does not detect the pres-
ence of that material, an error message displays for that position.
l If you fail to manually identify the presence of a material (tube, bottle or sample cup) placed on the
offline rack (sample, diluent, or reagent rack) and upon insertion, the bar code reader detects the pres-
ence of a material, an error message displays for each detected position the system was not expecting.

Manually Identifying Inserted Rack Material

To manually identify inserted rack material:
1. Insert the rack with the material to identify manually (non-bar coded material). The system generates
an alarm.
2. In the Diluent or Reagent Area screen, double-click the rack containing the unidentified material (dis-
played with a question mark) to access the Rack Details screen.
3. Select the position to identify.
4. Select the Add/Remove Material icon in the toolbar.

5. Select the material from the Materials window.
NOTE:
l When the material is in use, manual identification is disabled until the rack is removed.
There are two ways to identify a material on board the ACL TOP instrument:
l Automatic Material Identification
l Manual Material Identification

Automatic Material Identification – Using the Bar Code Reader

The ACL TOP instrument performs automatic material identification using a 1D bar code reader.
1D B ar C ode R eader
The 1D bar code reader is built into the ACL TOP instrument and is configured in Setup/Bar code Def-
initions Setup.
1D B ar C odes
A material rack containing 1D bar coded material is inserted into the instrument. The the built-in bar code
reader reads the bar coded label looking for a match in the Materials database. If found, the information (mate-
rial name, type, lot number, expiration date, stability, etc) is displayed.
Inserting a rack or scanning material disables manual identification for bar coded materials. If the bar code
label is not readable, does not match the material definition information, or is otherwise unusable, manual
identification may be used to identify the material.
Update of Material Information
2D B ar C ode R eader
(Sold as an option for some models.)
The 2D bar code reader is external to the ACL TOP instrument and is hand held. See 2D Bar Code Scanner.
Bi-dimensional (2D) bar codes have been added to the boxes of those products with value assignment (PT rea-
gents, calibrators and controls) to provide a means of importing lot specific information and assigned values
into the system. In a single operation, the bi-dimensional bar code scanner provides a way for you to scan the
2D bar codes to update lot information and related values such as ISI values for reagents, and assigned values
for calibrators and QC controls.
2D B ar C odes
An external hand held 2D bar code reader is used to scan 2D bar coded materials looking for a match in its
Materials database. If a match is found, the information for lot number, ISI values for reagents, and assigned
values for calibrators and QCs is updated.
If the matching information is not found, you must manually define it before it can be used. See Material Def-
inition.
Manual Material Identification – Using the Offline Rack

Use the offline or virtual rack to program the rack and maintain that information while the rack is not placed,
and you do not exit the application. After the rack is inserted, the information moves with the inserted rack
and is removed from the offline rack if one of the following occurs:
l The information read by the bar code reader matches what you have manually identified on the rack
l If the bar code reader has been disabled.
If the bar code reader is enabled but the scanned information does not match your offline rack information,
the offline rack information is not used.

See Also
l Bar Code Label Placement
l Reagents
l Sample Area

Bar Code Reader

The bar code reader moves to each track position to allow for insertion of sample, diluent or reagent racks.
Bar coded information on sample tubes or diluent or reagent bottles is scanned into the instrument as the
racks are inserted.
Move the bar code reader to the desired track using the track buttons on the front of the AM or by clicking
the virtual track buttons displayed on the Reagent area screen on the CM. With the bar code reader posi-
tioned in front of the track position, insert the rack. A track guides the insertion of the rack into its correct
position.
After the bar code reader has been at a track position for 30 seconds, or if the Run icon is selected, the
bar code reader moves back to its home position.
You can select the Home button displayed on the touch screen when the sample or reagent screen is
displayed to move the bar code reader (BCR) to its home position without having to wait for the BCR time-
out.
If the bar code reader is disabled, it will still scan the rack to detect vial presence. The material status
becomes Unknown.
CAUTION:
l Care should be taken when the bar code reader is moving so that your fingers do not get pinched.
l When you use the Home button, the Bar Code Reader warning light (located on the BCR cover)
blinks three times to warn you to clear the path. A rack incompletely placed in a track causes the hom-
ing function to fail, and displays the BCR movement failure error.

Bar Code Reader
TOP 300 CTS Bar Code Reader
TOP 500 CTS Bar Code Reader

TOP 700 Bar Code Reader

Includes the TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS instru-
ments.
See Also

2D Bar Code Scanner
2D Bar Code Scanner

(Sold as an option on some ACL TOP models.)
Overview
Bi-dimensional (2D) bar codes
2D bar code labels appear on boxes of products with value assignment (PT reagents, calibrators and controls).
This allows you to scan, import and update the following types of material information on the system:
l Material lot information
l Assigned values for calibrators and QC controls
l Related values (such as ISI values for PT reagents)
Setup
Refer to the Plug and Play Program Guide that accompanies the 2D bar code scanner for setup information.
Using the 2D Bar Code Scanner

To use the 2D bar code scanner:
1. Select Setup > Material List on the menu bar.
2. In the Material List, select the Scan icon in the toolbar.

3. Pull the trigger on the scanner to activate it. If communication with the device is successful, you are
prompted to scan the bar code. If communication is unsuccessful the Material List screen displays.
4. Scan the bar code label.

5. The bar coded information displays in the Verified barcode material data dialog box.
6. The system considers the newly scanned material as the alternate lot. Select the Toggle Lot button to
use the alternate lot (newly scanned material) on the system instead of the current active lot.
NOTE: Activating the alternative lot may necessitate calibration and validation. Refer to your
own laboratory procedures to determine the appropriate action.
7. To rescan the material, select the Retry button to clear the imported data, and scan the bar code label
again.
8. Select the Save button to update the Material List with the new scanned values for each material.
9. The new values do not replace the active lots when the scanned values are saved.

Verified Barcode Material Data dialog box
A status message appears below the table.

Generally, all scanned information is displayed for each material. A blank field indicates unknown,
unmatched or not applicable information.
Material Information
N ame
Name of the scanned material.
Index
Material identifier. Values are as follows:
l 1-500 – Material manufactured by Instrumentation Laboratory.
l 501-999 – User-defined material. Unique for each material.
Type
A material can be one of the following types:

2D Bar Code Scanner
l Intermediate reagent
l Start reagent
l Sample Diluent
l Quality Control
l Calibrator/NPP
l Clean
l Deficient Plasma
Import data
The scanned data area displays in the following two columns for comparison:
l New scanned data – Values of the newly scanned material. The system considers this the alternate
lot. (See Toggle Lot button.)
l Current Data (Active Lot) – Values of the same material that currently exists on the system.
The scanned values for each material are compared with the active lot information for the corresponding mate-
rial definition in the system.
Lot ID
An alphanumeric code that identifies where and when the material was manufactured.
Expiration date
The date when the material no longer meets the manufacturer’s specifications.
ISI value yes/no

Defines whether an ISI1 value is defined for the material.
ISI value
ISI value for the material.
B ottle type
Type of bottle that contains the material.
Column Descriptions
Errors
A check mark in this column indicates that additional information is available. Click a check mark to access
this information. An error does not necessarily mean a problem exists. In the example above, the error
1International Sensitivity Index. This value is provided by each Prothrombin Time (PT) reagent and used TO
calculate the International Normalized Ratio (INR).

indicates that the source of the assigned value available for import has units that are not defined for that test
on this instrument. This is a notification rather than a problem.
Buttons
Toggle Lot
Changes from active lot to alternate lot.
R etry
After a valid bar code is scanned and the results displayed, you can ignore them and scan again. Select the
Retry button to clear the screen data and re-enable the scan operation.
Save
A status message displays for each material shown. If all the scanned material definitions are available for
import, the Save button is enabled.
Select the Save button to update the Material List with the new scanned values for each material. The new
values do not replace the active lots when the scanned values are saved. You must still do calibrations, val-
idations, etc.
C ancel
Cancels the scan operation. You may cancel at any point during the scan procedure.
See Also
l Bar Code Reader

Reaction Cuvettes
Reaction Cuvettes
Cuvettes are packaged in boxes that contain 400 cuvettes. Each box contains 10 clips, each clip consisting of
10 strips of 4 cuvette cells. The instructions for opening the box and loading the cuvettes are printed on the
top of the box. The cuvette loader can hold up to 20 clips – a total of 800 cuvettes. Cuvettes may be loaded
at any time, regardless of the state of the ACL TOP instrument.
Cuvette Warning
The ACL TOP instrument generates a warning when the number of cuvettes falls below 3 clips (120 cells).
When the warning is generated, the cuvette loader LED in the auxiliary material status area of the Reagent or
Diluent Area screen becomes amber. In addition, the status light on the front of the AM1 turns amber, and a
yellow exclamation point appears on the Material Alarms button on the CM2.
Cuvette Error
When there are no cuvette strips in the cuvette loader, an error is generated. The Analytical Module stops
processing new samples and performs a controlled stop. The cuvette loader LED changes to red, and the AM
status light changes to red. A red exclamation point appears on the Material Alarms button on the Control
Module, and a message informs you that there are no more cuvettes available.
If you add more cuvette strips to the cuvette loader before the instrument performs a controlled stop, the
instrument continues performing whatever tests remain.
CAUTION Biohazard: Cuvettes waste is biohazardous. Use precautions when emptying the

cuvette waste drawer. Refer to local and state regulations for disposal of potentially hazardous materials.
See Also
l Additional Preparation

Rinse Fluid
Rinse fluid is used to rinse the probes during analysis.
Overview
Rinse fluid is packaged in a 4-liter bottle that is placed on the right side of the analyzer. A tube connecting
the bottle to the system allows the rinse to be drawn into the analyzer.
The ACL TOP instrument has a sensor that automatically detects the presence and volume of rinse fluid. The
warning sensor is not included on the ACL TOP 300 CTS. It generates a warning when the volume is below
1000 mL, and an error when the volume is less than 600 mL.
Material Alarm Warning

When the warning is generated, the Rinse fluid LED on the Auxiliary Material Status area of the Reagent
Area and Diluent Area screens turns amber, and a yellow exclamation point appears on the Material Alarm
Warning button on the CM1. The Rinse status light on the front of the analyzer turns amber.
Error Alarm Warning

When an error is generated, the analyzer stops processing new samples and performs a controlled stop. The
Rinse fluid LED changes to red, and a red exclamation point appears on the Material Alarm Error but-
ton on the CM. In addition, the Rinse status light on the front of the AM2 turns red. When the level of the
rinse fluid drops below 100 mL, the instrument performs an emergency stop.
Changing the Rinse Fluid

To change the rinse fluid:
1. Remove and discard the cap and foil from the new bottle.
2. Remove the cap with the tubing from the old bottle and discard the bottle.
3. Screw the old cap onto the new bottle.
4. Place the new bottle into its receptacle.
5. Check the tubing for large air bubbles, blockages, or kinks and remove if necessary.
The instrument detects when a new bottle of rinse is placed and performs an automatic priming cycle to
remove air bubbles from the rinse lines.

Rinse Fluid
NOTE: In step 3, the old cap has a siphon and tubing attached. Steps 3 and 4 can be reversed, but
doing them in order minimizes the amount of time the siphon is in the air, and minimizes the risk of air enter-
ing the tubing. If the cap assembly is damaged, remove the assembly by unclipping the tubing from the side
of the AM, remove the cap from the bottle and discard it. Replace it with a new assembly.
CAUTION:
l When replacing the rinse fluid, move computer, monitor and keyboard out of the way to prevent rinse
from spilling on them.
l The rinse bottle must be replaced when the instrument is not busy or in a controlled stop. Removing
the rinse bottle while the instrument is running causes an emergency stop.
l The 4 liter rinse bottle is not designed to refill during instrument operation. IL recommends periodic
changing of the rinse bottles to prevent accumulation of particulates and other contaminants.
l Do not top off. Refilling (topping off) the 4 liter rinse bottle during operation may cause air bubbles
in the tubing. This can happen when the bottle is close to empty, or if the end of the tubing is raised
above the liquid level. Bubbles in the rinse fluid can enter the rinse tubing and cause improper rinsing
of the probes. Take extra care to prevent bubbles when manipulating the contents of the rinse bottle.
l Allow the rinse sensor to turn to red before replacing the bottle. This ensures the system performs an
autoprime when the new bottle of rinse is detected and the sensor turns off.
See Also

Clean Fluid
Clean fluid is used to clean the probes during analysis. This occurs when specified in a test parameter, or
through a maintenance activity.
Overview
The clean fluid is packaged in a 500 mL bottle that is placed on the right side of the analyzer. A tube con-
necting the bottle to the system allows the cleaning solution to be drawn into the analyzer.
The ACL TOP instrument has a sensor that automatically detects the presence and volume of the clean fluid.
The warning sensor is not included on the ACL TOP 300 CTS. It generates a warning when the volume is
below 75 mL and an error when the volume is less than 25 mL.
When the warning is generated, the Clean fluid LED on the Auxiliary Material Status area on the Reagent
Area and Diluent Area screens turns amber and a yellow exclamation point appears on the Material Alarm
Warning button on the CM1. In addition, the Clean status light on the front of the AM turns amber.
When the error is generated, the analyzer stops processing new samples and performs a controlled stop. The
Clean fluid LED changes to red, a red exclamation point appears on the Material Alarm Error button
and a message informs you that there is no more clean fluid available. In addition, the Clean status light on
the front of the AM turns red. If no clean fluid is detected in the clean well the instrument performs an emer-
gency stop.
CAUTION:
l Clean fluid contains hydrochloric acid and must be handled carefully. DO NOT ALLOW CLEAN
FLUID TO COME IN CONTACT WITH SKIN OR EYES. When handling or changing clean solu-
tion bottles, wear protective eyewear, protective gloves and protective garments.
l When replacing the clean fluid, move the computer, monitor and keyboard to prevent clean fluid from
spilling on them.
NOTE:
l The clean bottle must be replaced when the instrument is not in the BUSY or CONTROLLED STOP
state.
l If the system detects a lack of clean fluid in the clean well (for example, caused by an air bubble in
the tubing reaching the clean well) an alarm is generated and the instrument performs an emergency
stop.
l A Rinse/Clean Priming Cycle for each probe can be performed in Maintenance to remove air bubbles
from the clean line.

Clean Fluid
Changing the Clean Fluid

To change the clean fluid:
1. Remove the cap from the new bottle and discard it.
2. Remove the cap from the old bottle.
3. Screw the old cap onto the new bottle.
4. Place the new bottle into its receptacle.
NOTE:
l In step 3, the old cap has a siphon and tubing attached. Steps 3 and 4 can be reversed, but doing them
in order minimizes the amount of time the siphon is in the air, and minimizes the risk of air entering
the tubing. If the cap assembly is damaged, remove the assembly by unclipping the tubing from the
side of the AM, remove the cap from the bottle and discard it. Replace it with a new assembly.
l The instrument detects when a new bottle of clean fluid is placed, and performs a priming cycle to
remove air bubbles from the clean lines.
See Also
l Performing Maintenance Activities

Fluid Waste
System fluid waste consists of the clean and rinse fluids used by the instrument during analysis and main-
tenance operations.
Overview
System fluid waste is discharged at the waste position located in the rinse/clean station for each probe. Inter-
nal waste reservoirs that reside underneath the rinse/clean stations hold the waste fluid until enough fluid
builds up to trip the waste accumulator sensor which in turn starts the waste pump.
NOTE: The TOP 300 CTS uses gravity to empty waste fluid from the reservoirs. A sensor indicates
when fluids fail to empty. If fluids back up, the system performs an emergency stop.
The waste pump empties the internal waste reservoirs through tubing into a waste container that is located
below the AM1. This container has its own sensor that detects when the container is nearly full. This causes a
warning message to display in Material Alarms, and the Fluid Waste LED on the front of the analyzer
changes to amber. If the nearly full waste container is not replaced with an empty one, the system generates
an error message after a predefined interval.
Material Alarms Warning
When an error is generated, the AM stops processing new samples and performs a controlled stop. The Fluid
Waste LED changes to red, a red exclamation point appears on the Material Alarms button, and a message
states that the waste container is full. At the conclusion of the controlled stop, an error displays on the CM2
instrument status.
Material Alarms Error
If the waste container continues to fill, an emergency stop is performed and an error message is generated in
the Materials Alarm window that states: Unable to empty the internal waste reservoir.

Fluid Waste
Changing the Fluid Waste Container

To change the fluid waste container:
1. Remove the cap from the new container and discard it.
2. Remove the cap from the old container.
3. Screw the old cap onto the new container.
4. Place the new container into its receptacle.
NOTE:
l In Step 2 the old cap has tubing attached to it. Steps 3 and 4 can be reversed, but doing them in order
minimizes the amount of time the tubing is in the air and the risk of fluid waste dripping outside the
waste container. If the cap assembly is damaged, remove the assembly by unclipping the tubing from
the side of the AM, remove the cap from the container, and discard it. Replace it with a new
assembly.
l If bleach was used, rinse the waste bottle with distilled water.
l Do not fill the bottle with bleach after you empty it.
l Make sure the lollipop sensor is secure against the side of the waste bottle. The ACL TOP 300 CTS
does not contain the lollipop sensor. See Empty Waste Fluid.
CAUTION Biohazard: System fluid waste is biohazardous. Use precautions when changing

or emptying the fluid waste container.
See Also
l Controlled Stop
l Emergency Stop
l System Decontamination

Reagents
The term reagents includes both chemical reagents and deficient plasmas. Reagents are classified as inter-
mediate reagents and start reagents. Depending on the instrument model, the reagent type may require a spe-
cific placement location on the instrument. The instrument prompts with the proper placement.
Start Reagent
A start reagent is a reagent that, when mixed with sample or a sample mixture1, activates the reaction in the
optical reading unit (ORU). It is the last material added to the cuvette.
Intermediate Reagent
An intermediate reagent is a reagent that, when mixed with sample, activates certain ingredients of the sam-
ple but is not enough to bring the reaction to the desired completion.
The reagent rack positions hold the 15 mL and 20 mL bottles. IN addition, 4 mL and 10 mL bottles can be
used with the proper adapters (see Material Definition). There is an adapter for each of these bottles that
allows these smaller bottles to be seated correctly in the rack position while allowing the bar code label on
the bottle to be read.
Bottle Adapters
Reagents are placed in reagent racks inserted into reagent tracks, but can also be placed in a diluent rack.
Placing a reagent in the wrong position in the Reagent Area results in a warning message. See Restriction
Map.
A warning message appears if the volume of a reagent falls below the limit defined as the warning threshold.
An error message appears when the bottle is empty. When multiple bottles of the same reagent are placed on-
board the instrument, after the volume in the bottle with a priority of 1 changes to 0, the probe moves to the
bottle with the priority of 2, then 3, etc. No further aspirations occur on bottles with a volume of 0.
See Also
l Managing Materials
l Restriction Map
1A dilution that requires a two-step dilution process to achieve the required dilution ratio.

Calibrators and NPP
Calibrators and NPP

Calibrator (Cal)
Calibrator is a type of sample with an assigned value used to calibrate a test.
Normal Pool Plasma (NPP)

Normal Pool Plasma is a type of sample used as a standard of comparison. It is used in the calculation of the
INR1 and in the calculation of test results that use the normalized ratio.
worldwide.

Quality Controls
Quality control (QC) materials can be placed in the ACL TOP instrument as follows:
l On diluent racks accessible by the sample arm.
l On sample racks in the Sample Area.
See Restriction Map for placement restrictions.
When you use sample cups in the sample racks, you cannot use bar codes, and therefore ACL TOP material
tracking features such as volume warning, on-board stability tracking, and expiration date tracking cannot
be used.
See Also
l QC Overview
l QC List
l QC Profiles List
l QC Results List

Samples
Samples
A sample is an aliquot1 of patient plasma from a primary sample tube or aliquot cuvette. Sample can also
refer to the material on which the test is being performed, including calibrators, controls, and NPP2 mate-
rials.
Samples are placed on sample racks that are inserted into tracks in the Sample Area of the ACL TOP instru-
ment. See Restriction Map. You may use either primary tubes or sample cups.
NOTE:
l If sample cups are used, they must be IL 2.0 mL sample cups. Using non-IL sample cups may lead to
improper sampling and incorrect results. See Parts and Consumables List.
l The amount of plasma in a sample tube must be sufficient to complete the tests and also avoid the
probe syringe tip entering the red blood cell level, which would contaminate the probe and com-
promise patient results.
Bar coded sample tubes provide the ACL TOP instrument with the required sample ID information. If the sam-
ple tubes are not bar coded, you must provide the sample ID.
NOTE: You cannot change a sample ID if the test status for that sample is ACTIVE.
1A known fraction of a whole, constituting a sample.


Sample Containers and Adapters
Sample Adapters for Open and Closed Tubes
CAUTION: Fill sample tubes with enough plasma to complete the tests and to avoid entering the red
blood cell level, which would contaminate the probe and compromise patient results.
Open sample racks are designed to work with a variety of sample tubes and associated adapters to ensure the
tubes are held firmly in place during aspiration and the maximum amount of plasma is available for use.
CTS sample racks are designed to accommodate a variety of different tubes. The use of specially designed
adapters is needed to ensure that the tubes are held firmly in place during the piercing and aspiration rou-
tines, and to ensure that the maximum amount of plasma is available for use.
If the surface of the liquid is below the bottom level of the sample cup (which represents the maximum depth
the sample probe can reach) the sample cannot be aspirated. The following types of adapters are available to
address this risk:
l Aliquot sample tube adapter – Raises the bottom of the aliquot tube to the same height as the bot-
tom of the sample cup. Aliquot tube adapters are black.
l Pediatric sample tube adapter – Similar to the aliquot sample tube adapter, but with a smaller dia-
meter to hold these thin tubes centered in the sample position. It has been validated to work with 1.8
mL and 2.7 mL tubes. Pediatric tube adapters are blue.
l Microtube adapter– Use exclusively with the Sarstedt 1.3 mL Microtube. Microtube adapters are
green.
l CTS adapter – CTS adapters are red and must be used with the CTS rack.
l Sarstedt CTS adapter – Sarstedt CTS adapters are red and must be used with the red Sarstedt CTS
rack.
It is important to use the correct adapter with the correct tube type to avoid aspiration errors, probe errors,
and probe contamination.
CAUTION: You must use only closed tubes on CTS sample racks. Use regular, uncapped, sample
tubes and sample cups on open tube sample racks. Failure to use the proper rack (standard rack for open
tubes; closed rack for closed tubes) may result in probe damage.

Sample Tube Adapter
Adapter in Sample Rack

Sarstedt Closed Tube Sample (CTS) Rack and Adapters

10 position Sarstedt CTS Rack
These racks and adapters increase the cap piercing reliability of the closed Sarstedt primary sample tubes on
ACL TOP CTS instruments.
l 10% bleach
l 0.1 N HCl
l Mild soap

2-sided Sarstedt Tube Adapter
Sarstedt Tube Adapter

This tube adapter accepts all sizes of Sarstedt coagulation tubes by changing the orientation of the adapter in
the Sarstedt CTS rack. One side of the adapters have an opening that accepts larger diameter caps. Proper
orientation is essential for reliable cap piercing of Sarstedt tubes.
Adapter Orientation 1 – Indicator (hole) up

With the indicator side up, the adapter accepts and securely holds Sarstedt tubes with cap diameters of 16.3
mm. (for example, Sarstedt part number 04.1902.100, 2.9 mL fill volume).
Adapter Orientation 2 - Indicator (hole) down

With the indicator side down, the adapter accepts and securely holds Sarstedt tubes with cap diameters of
14.0 mm (for example Sarstedt part number 05.1165.100 or 05.1071.100 with 3.0 mL or 5 mL fill).

Validated Uncapped Sample Containers

The containers in the following table are valid for all ACL TOP models with uncapped tubes loaded in open
tube sample racks.
For a list of validated uncapped primary sample tubes that can be directly sampled from an LAS track, see
Validated Uncapped Sample Containers – LAS Track.
CAUTION: Use extra caution when using glass tubes which are prone to breakage.

Sample Container Source/Available Adapter Needed Why Adapter
Type Part No. Needed
2.0 mL Cup IL P/N 55751-00 N/A
1.8 mL Pediatric Vacu- Becton Dickinson Pedi (IL P/N 285246-00) Small OD, Low
tainer® 366392 (IL P/N 285335-00) set of 10 fill volume
1.8 mL Plastic Vacu- Becton Dickinson N/A
tainer® 363080
2.7 mL Pediatric Vacu- Becton Dickinson Pedi (IL P/N 285246-00) Small OD, Low
tainer® 366393 (IL P/N 285335-00) set of 10 fill volume
2.7 mL Plastic Vacu- Becton Dickinson N/A
tainer® 363083
4.5 mL Vacutainer® Becton Dickinson N/A
369714
4.5 mL Vacutainer® Becton Dickinson N/A
366415
2 mL Greiner Bio-One Greiner Bio-One Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
Vacuette® * 454321 285334-00) set of 10
3.5 mL Greiner Bio- Greiner Bio-One N/A
One Vacuette® 454327
1.3 mL Micro Tube * Sarstedt Micro (IL P/N 285296-00) Small OD, Low
41.1506.005 (IL P/N 285337-00) set of 10 fill volume
2.9 mL S-Monovette® Sarstedt N/A
04.1902.100
3 mL S-Monovette® Sarstedt N/A
05.1165.100
5 mL S-Monovette® Sarstedt N/A
05.1071.100
1.8 mL Venosafe® Terumo VF- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
052SBCS07 285334-00) set of 10
2.7 mL Venosafe® Terumo VF- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
053SBCS07 285334-00) set of 10
3.6 mL Venosafe® Terumo VF- N/A
054SBCS07


Sample Container Source/Available Adapter Needed Why Adapter
Type Part No. Needed
1.8 mL Venoject II® Terumo VP- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
C052K 285334-00) set of 10
2.7 mL Venoject II® Terumo VP- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
CW053K 285334-00) set of 10
4.5 mL Venoject II® Terumo VP- N/A
CW050K
1.8 mL Nipro sample Nipro NP-CD0185 Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
tube NP-CS0185 285334-00) set of 10
2.7 mL Nipro sample Nipro NP-CD0275 Aliquot (IL P/N 285245-00) (IL P/N Hold tube in rack
tube NP-CS0275 285334-00) set of 10
3.6 mL Nipro sample Nipro NP-CD0365 N/A
tube NP-CS0365
1.8 mL Sekisui sample Sekisui SPM- Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
tube K0502S 285334-00) set of 10
1.8 mL Sekisui sample Sekisui ST-518SC Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
tube 285334-00) set of 10
Aliquot Tube Fisherbrand P/N Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
14-956 3D 285334-00) set of 10
Aliquot Tube Corning® P/N Aliquot (IL P/N 285245-00) (IL P/N Low fill volume
430662 285334-00) set of 10
* Tubes are usable when filled to nominal levels. However, the amount of usable plasma will be lower than
500uL.

Validated Uncapped Sample Containers for LAS – Track Only

Only the following tubes may be used on the LAS track.
Validated Uncapped Sample Containers for LAS - Track Only

Sample Container Type Source/Available Part No.
1.8 mL Plastic Vacutainer® Becton Dickinson 363080
2.7 mL Plastic Vacutainer® Becton Dickinson 363083
4.5 mL Vacutainer® Becton Dickinson 369714
4.5 mL Vacutainer® Becton Dickinson 366415
2 mL Greiner Bio-One Vacuette® Greiner Bio-One 454321
3.5 mL Greiner Bio-One Vacuette® Greiner Bio-One 454327
2.9 mL S-Monovette® Sarstedt 04.1902.100
3 mL S-Monovette® Sarstedt 05.1165.100
5 mL S-Monovette® Sarstedt 05.1071.100
1.8 mL Venosafe® Terumo VF-052SBCS07
1.8 mL Venoject II® Terumo VP-C052K
2.7 mL Venoject II® Terumo VP-CW053K
4.5 mL Venoject II® Terumo VP-CW050K
1.8 mL Nipro sample tube Nipro NP-CD0185, NP-CS0185
1.8 mL Sekisui sample tube Sekisui SPM-K0502S
1.8 mL Sekisui sample tube Sekisui ST-518SC

Validated Capped Sample Containers for CTS – Piercing Mode Ena-

bled
These containers are valid for use on all ACL TOP CTS models. Piercing mode must be enabled.
Validated Capped Sample Containers for CTS – Piercing Mode Enabled

Sample Container Source/Available Adaptor needed Rack needed
Type Part No.
1.8 mL Pediatric Vacu- Becton Dickinson Pedi (IL P/N 285246-00) CTS sample rack (IL
tainerâ 366392 (IL P/N 285335-00) set of 10 P/N 294008)
1.8 mL Plastic Vacu- Becton Dickinson N/A CTS sample rack (IL
tainerâ 363080 P/N 294008)
2.7 mL Pediatric Vacu- Becton Dickinson Pedi (IL P/N 285246-00) CTS sample rack (IL
tainer® 366393 (IL P/N 285335-00) set of 10 P/N 294008)
2.7 mL Plastic Vacu- Becton Dickinson N/A CTS sample rack (IL
tainer® 363083 P/N 294008)
4.5 mL Vacutainer® Becton Dickinson N/A CTS sample rack (IL
369714 P/N 294008)
4.5 mL Vacutainer® Becton Dickinson CTS (IL P/N 285288-00) CTS sample rack (IL
366415 (IL P/N 285336-00) set of 10 P/N 294008)
3.5 mL Greiner Bio- Greiner Bio-One N/A CTS sample rack (IL
One Vacuette® 454327 P/N 294008)
2.9 mL S- Sarstedt Sarstedt (IL P/N 285821-00) Sarstedt sample rack
Monovette® *° 04.1902.100 (IL P/N 294127-00 set of 10) (IL P/N 285831)
3 mL S-Monovette® Sarstedt Sarstedt (IL P/N 285821-00) Sarstedt sample rack
*° 05.1165.100 (IL P/N 294127-00 set of 10) (IL P/N 285831)
5 mL S-Monovette® Sarstedt Sarstedt (IL P/N 285821-00) Sarstedt sample rack
*° 05.1071.100 (IL P/N 294127-00 set of 10) (IL P/N 285831)
2.7 mL Venosafe® Terumo VF- Aliquot (IL P/N 285245-00) (IL CTS sample rack (IL
053SBCS07 P/N 285334-00) set of 10 P/N 294008)
2.7 mL Venoject II® Terumo VP- Aliquot (IL P/N 285245-00) (IL CTS sample rack (IL
CW053K P/N 285334-00) set of 10 P/N 294008)
° Sarstedt sample rack (IL P/N 285831) is needed to run in closed tube mode. See Sarstedt Sample Rack.
* When using Sarstedt 5 mL Monovette tubes on a CTS instrument, always leave the sample tracks to the
right of these tall tubes empty unless the rack to the right also contains Sarstedt 5 mL Monovette tubes. Do
not place shorter tubes with these 5 mL tall tubes on the same rack. With the exception of the 5 mL tubes, all
other tubes can be mixed and matched in the same rack, and do not require empty rack positions on the right
side. This requirement ensures the foot does not hit the tall Sarstedt tube while it is trying to reach the shorter
(i.e., 1.8 mL Pedi) tube.

Validated Capped Sample Containers for CTS – Lower Z Piercing

Mode Enabled
Use the following tubes when the Enable Lower z-depth CTS option is enabled.
Validated Capped Sample Containers for CTS – Lower Z Piercing Mode

Enabled
Sample Container Source/Available Adapter Needed Why Adapter Needed
Type Part No.
1.8 mL Sekisui sample ST-518SC-J2 (IL P/N 285334-00) set CTS sample rack (IL P/N
tube * of 10 294008)
* Validated for use in CTS mode without Lower Z piercing mode enabled. However the usable volume will
be 200 uL or less.

Sample Containers Not Recommended for CTS

These containers are not recommended for use on ACL TOP when capped.

Sample Source/Available Why NOT RECOMMENDED for CTS
Container Part No. (Piercing mode enabled)
Type
2.0 mL Cup IL P/N 55751-00 Uncapped sample containers are not to be used with CTS sample racks.
Sampling from open tube when CTS is in pierce mode (sample may not be
collected correctly).
Aliquot Fisherbrand P/N Uncapped sample containers are not to be used with CTS sample racks.
Tube 14-956 3D Sampling from open tube when CTS is in pierce mode (sample may not be
Aliquot Corning® P/N Uncapped sample containers are not to be used with CTS sample racks.
Tube 430662 Sampling from open tube when CTS is in pierce mode (sample may not be
1.3 mL Sarstedt Push cap material is not pierce-able.
MicroTube 41.1506.005 Use in only OPEN mode only; remove flip cap; via analysis and test this
(capped) tube at best has a usable volume of 200 uL. This micro tube has anti-
coagulant in the tube and a flip top, so it is not a vacutainer tube nor is it
an aliquot tube. The user draws blood via a syringe and then fills the tube
and mixes the blood with the anticoagulant. Used in OPEN mode only.
1.8 mL Seki- Sekisui SPM- Cap of SPM-U0502S has indented core (diameter close to that of piercing
sui sample K0502S (change probe). May be problematic for CTS. The piercer may not be able to center
tube in cap material) on the indented core correctly and pierce.
(capped) *
1.8 mL Seki- Sekisui SPM- This tube does not meet TOP SyRS-2430 which states that a sample tube
sui sample K0502S (excludes aliquot tubes) must have a minimum usable volume of 500 uL (10
tube PT assays) in order for it to be considered acceptable for use on the system.
(capped) Currently an average of only 250 uL can be aspirated out of this tube. The
reason for this is because the distance from the cap to the fill line is 52.50
mm and the CTS probe can only travel 54 mm from the top of the cap into
the tube. Also if the tube is not filled to the fill line then no test can be
done on this tube.
4.5 mL Terumo VP- This tube has a high fill volume; there is not enough clearance between the
Venoject CW050K top of the plasma and the bottom of the cap during sample probe aspiration.
II® (capped) Using this capped sample tube in a CTS sample rack results in the probe
diving into the fluid during aspiration and possibly contaminating the
probe or resulting in fluidic imprecision.
3.6 mL Terumo VF- This tube has a high fill volume; there is not enough clearance between the
Venosafe® 054SBCS07 top of the plasma and the bottom of the cap during sample probe
(capped) aspiration. Using this capped sample tube in a CTS sample rack results in
the probe diving into the fluid during aspiration and possibly con-
taminating the probe or resulting in fluidic imprecision.
1.8 mL Nipro NP- Tests revealed that the caps appear to be more elastic then other man-


Sample Source/Available Why NOT RECOMMENDED for CTS
Container Part No. (Piercing mode enabled)
Type
Nipro sam- CD0185, NP- ufactures and that this cap produces larger pieces of coring compared to
ple tube CS0185 other brands. The analytical precision of these tubes, does not meet accept-
(capped) ance criteria for precision. This tube functions well only in NONCTS mode.
SARSTEDT Sarstedt Carrier with tube above ZMax. Needs adapter to fit on sample racks. Can
Mono- 06.1668.001 only aspirate 80 uL.
vette® 1.4
mL sample
tubes
Greiner pedi- Greiner P/N This tube cannot be pierced. Also because the inside of this tube is tapered
atric tube 1 450413 there is a possibility of coming out of liquid for some test on our list.
mL
See Also

Diluents
Diluents
A diluent is a liquid used to reduce the concentration of another liquid. A sample diluent reduces the con-
centration of sample material; a reagent diluent reduces the concentration of reagent material.
Sample diluents must be placed in a diluent rack. Placing a sample diluent in the wrong position causes a
warning message. See Restriction Map.
The first two positions on the diluent rack hold 30 mL bottles, but can be used for 4 mL, 10 mL, and 20 mL
bottles providing the correct adapter is inserted into the position on the rack. There is an adapter for each of
these smaller bottles that allows them to be seated correctly in the rack position while allowing the bar code
label on the bottle to be read. These adapters are red to distinguish them from the reagent rack adapters.
Bottle Adapters
A warning message is displayed if the volume of a diluent falls below the limit defined as the warning thresh-
old. See Material Definition. An error message is displayed when the bottle is determined to be empty.
See Also
l Restriction Map

Restriction Map
Overview
The Restriction Map shows which types of materials may be placed onto which tracks. It also the shows the
types of racks that may be placed and their corresponding track positions.
Important Considerations
l Place sample tubes and reagent/diluent bottles on the rack carefully to avoid damaging the bar code
labels. Make sure the labels can be read by the bar code reader.
l Use the tracks to guide the racks into the correct position. Improper seating of the rack can cause spil-
lage.
Accessing the Restriction Map

To open the Restriction Map:
1. Select one of the following icons in the toolbar to open the corresponding area:
Sample Area
Reagent Area
Diluent Area
2. Select the Restriction Map icon in the toolbar, or select Actions > Review > Restriction Map
in the menu bar.

Restriction Map
TOP 300 CTS Restriction Map
A bottle in a cell means that the material can be placed in the corresponding track position. For example:
l A patient sample may be placed in any track from S1 to S4.
l A calibrator1 sample may be placed in Sample tracks S1 - S4 plus diluent tracks D1.
l Sample diluents are restricted to tracks D1, reagent diluents to tracks D1 and R1-R3.
NOTE:

l If you define a sample clean material and select the Clean and Rinse option requiring a non-system
clean material such as Clean B diluted, that clean material must be placed in track D1.
l Non-system clean materials used by the reagent probes must be placed in tracks D1, or R1-R3.

Restriction Map
TOP 500 CTS Restriction Map
l A Patient sample may be placed in any track from S1 to S8.
l A Calibrator sample may be placed in Sample tracks S1 - S8 plus diluent tracks D1.
l Sample diluents are restricted to tracks D1, reagent diluents to tracks D2 and R1 - R4.
NOTE:
clean material such as Clean B diluted, that clean material must be placed in track D1.
l Non-system clean materials used by the reagent probes must be placed in tracks D2, or R1-R4.

TOP 700 Restriction Map

The following is the restriction map on ACL TOP 700 (includes ACL TOP Base) and ACL TOP 700
CTS (includes ACL TOP CTS) instruments:
l A Calibrator sample may be placed in Sample tracks S1 - S12 plus diluent tracks D1 and D2.
l Sample diluents are restricted to tracks D1 and D2, reagent diluents to tracks D3 and R1 - R4.
NOTE:
clean material such as Clean B diluted, that clean material must be placed in track D1 or D2.
l Non-system clean materials used by the reagent probes must be placed in tracks D3, R1, R2, R5,
and/or R6. Do not place non-system clean materials in tracks R3 or R4.

Restriction Map
TOP 700 LAS Restriction Map
l A Calibrator sample may be placed in Sample tracks S4 - S12 plus diluent tracks D1 and D2.
l Sample diluents are restricted to tracks D1 and D2, reagent diluents to tracks D3, and R1 - R4.
NOTE:
l Tracks S1 - S3 are unavailable on the LAS.
clean material such as Clean B diluted, that clean material must be placed in track D1 or D2.
l Non-system clean materials used by the reagent probes must be placed in tracks D3, R1, R2, R5,
and/or R6. Do not place non-system clean materials in tracks R3 or R4.
See Also
l Reagent Area
l Diluent Area

Closed Tube Sampling
WARNING Piercing Hazard: Do not put hand inside instrument while sample arm is in motion.
CAUTION Biohazard: In the unlikely event that the CTS piercer probe gets stuck or jammed
in the cap of a primary sample tube, do not attempt to remove the cap. Call Service for assistance. The CTS
piercer probe assembly is delicate, very sharp, and biohazardous. The removal of a stuck cap from the piercer
probe could cause personal injury or damage to the instrument.
Overview
In Closed Tube Sampling (CTS) mode, the instrument accepts both CTS sample racks and open tube sample
racks.
CAUTION: You must use only closed tubes on CTS sample racks. Use regular, uncapped, sample
tubes and sample cups on open tube sample racks. Failure to use the proper rack (standard rack for open
tubes; closed rack for closed tubes) may result in probe damage.
Sample tube adapters used with the CTS sample racks are listed in CTS Capped and Uncapped Sample Con-
tainers and Adapters.
With CTS mode disabled, the instrument does not accept CTS sample racks. If a CTS sample rack is inserted
an error message displays: CTS rack rejected. When CTS is disabled, the instrument runs only uncapped
tubes and sample cups on open tube sample racks.
If you try to disable the CTS mode while CTS racks are on the instrument, a message displays: Unable to dis-
able CTS mode. CTS racks currently in use.
The following diagram shows the piercer/probe in the piercing mode (on left) and in the sample probe mode
(on right).

Enabling/Disabling CTS Mode

To enable/disable CTS mode:
1. Make sure the instrument is in the READY state.
3. In the Global Definitions screen, select or clear the Enable piercing mode option in the CTS param-
eters section.

Closed Tube Sampling (CTS) Probe

The piercer probe assembly consists of both a piercer and a sample probe located in a piercer assembly. This
assembly is designed for sampling from capped primary sample tubes. The CTS piercer probe assembly has a
foot to hold the sample tube in place, allowing the piercer to cut through the cap. After the piercer cuts
through, the foot remains on the cap long enough to allow the probe to move down into the tube to aspirate
material. The debris from piercing the cap is collected by the piercer and deposited into a filter at the sample
arm rinse station.
Sample Arm CTS Probe
Sample Tube Cap Piercing

After aspirating the sample, the CTS/Sample arm moves to the wash station and performs a deep wash. Pres-
surized air is released through the piercer/probe to blow out any material that might remain following a wash
or rinse.
Special CTS racks are used for cap piercing. These racks are labeled CTS on the front of the rack.
CAUTION: If a cap is not detected on a sample tube placed in a CTS rack, an alarm displays. In this
case, remove the tube from the CTS rack and load it onto an open-tube sample rack. Use only capped sample
tubes on CTS racks. Use sample cups and uncapped sample containers on open-tube sample racks.
CTS Sample Rack

l 10% bleach
l 0.1 N HCl
l Mild soap

Sarstedt Closed Tube Sample (CTS) Rack and Adapters
10 position Sarstedt CTS Rack
These racks and adapters increase the cap piercing reliability of the closed Sarstedt primary sample tubes on
ACL TOP CTS instruments.
l 10% bleach
l 0.1 N HCl
l Mild soap

2-sided Sarstedt Tube Adapter
Sarstedt Tube Adapter

This tube adapter accepts all sizes of Sarstedt coagulation tubes by changing the orientation of the adapter in
the Sarstedt CTS rack. One side of the adapters have an opening that accepts larger diameter caps. Proper
orientation is essential for reliable cap piercing of Sarstedt tubes.
Adapter Orientation 1 – Indicator (hole) up

With the indicator side up, the adapter accepts and securely holds Sarstedt tubes with cap diameters of 16.3
mm. (for example, Sarstedt part number 04.1902.100, 2.9 mL fill volume).
Adapter Orientation 2 - Indicator (hole) down

With the indicator side down, the adapter accepts and securely holds Sarstedt tubes with cap diameters of
14.0 mm (for example Sarstedt part number 05.1165.100 or 05.1071.100 with 3.0 mL or 5 mL fill).
See Also
l CTS Capped and Uncapped Sample Containers and Adapters

Sample Area
Sample Area
See Sample Area under Sample Analysis.

Reagent Area
This topic applies to the following models:
l TOP 700 (includes TOP Base)
l TOP 700 CTS (includes TOP CTS)
l TOP 700 LAS
For TOP 500 CTS and TOP 300 CTS models, see Reagent/Diluent Area.
Overview
The reagent area includes the 6 right-most tracks on the right side of the AM. It is cooled to 15° C ± 3°. This
screen is functionally similar to the Sample Area screen. Each reagent rack in the reagent area holds up to six
20 mL or 15 mL bottles, but can also be used for the 4 mL and 10 mL bottles providing the correct adapter is
inserted into the position on the rack. (See Reagents and Restriction Map.) When placed on-board the
analyzer, the first two positions (#1 and #2) in each reagent rack provide stirring capability if a stir bar has
been placed in the reagent bottle.
Accessing the Reagent Area and Rack Details

To access the Reagent Area and Rack Details:
1. Select the Reagent Area icon in the toolbar, or select Analysis > Reagent Area in the menu
bar to open the Reagent Area.
2. Double-click a position on the offline rack (located on the left side of the screen) to open the Reagent

Reagent Area
Programming Non-Bar Coded Reagents Using the Offline Rack
1. Select the Reagent Area icon, or select Analysis > Reagent Area in the menu bar.
2. Double-click a rack to open the Rack Details screen.
3. Select a position in the rack, then select the Add/Remove Material icon to open the Materials
window with that rack position in focus.
4. Select a reagent button to place that reagent in the reagent rack position. (See Material Programming
Window for configuring this window with reagents to select.)
5. To program additional reagents on the rack, select a position and repeat the previous step.
6. When you have programmed all the materials on the rack, select the Insert Rack icon in the
toolbar.
7. Insert the rack into the instrument.
NOTE: If for any reason a sample, diluent or reagent material that you manually program on an off-
line rack (through the Control Module1) does not match the bar code on the tube or bottle, an error is issued.
This includes failing to program a material the instrument detects.
CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before
loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in
misidentification of rack contents.

Viewing On-board Materials
The Reagent & Diluent Map displays on-board materials in table format.
To view on-board materials:
1. Select the Sample Area , Diluent Area or Reagent Area icon in the toolbar to
open the Sample, Diluent or Reagent Area.
2. Select Actions > Review > Reagent & Diluent Map in the menu bar.
3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials by
position in each rack.
4. Select the Reagent Area tab to view the on-board reagents by position in each rack.
5. Select the right and left arrows below the table to display more racks.

Reagent Area
Reagent Area Operations Toolbar
Run Tests – Starts the analytical session. Disabled if the analyzer is not in Ready status. Same as
Actions > Map > Run Tests in the menu bar.
Test Feasibility List – Opens the Test Feasibility List which indicates the following:
l Whether the test is feasible. A red X indicates the test is not feasible.
l Whether the materials have been correctly placed.
l Number of tests that can run based on the volume of materials on-board.
You can add and run tests while the analyzer is running.
Restriction Map – Opens the Restriction Map. Also select Actions > Review > Restriction Map
in the menu bar.
Rack Details – Opens the Rack Details screen for the rack that has focus in the Reagent Area
screen.
Bar Code Home Position – Moves the bar code reader to its home position.
Print – Prints a report that contains the following:

l State of all inserted racks with material placed on-board.
l State of on-board materials.
This report is useful when a maintenance activity is performed requiring removal of material racks.

Reagent Rack Details Operations Toolbar
Add/Remove Materials – Opens the Materials window where you select a reagent to add to the
reagent rack position in focus.
Clear rack information – Clears all reagents from the rack in focus.
Bar Code and Comments – Opens the Bar Code Edition dialog box where you can add a com-
ment about the rack position in focus.
Insert Rack – Inserts the rack into the instrument.
Print – Prints the rack details report for the rack displayed.
NOTE: After selecting Run:

l The instrument issues a warning if an enhanced clean is required. You must perform the enhanced
clean before running any other operations. See Enhanced Clean in Performing Maintenance Activ-
ities.
l The instrument issues a warning if temperatures are out of range. You can confirm to run the current
operation, or cancel and wait until the temperatures are in range.
l The instrument issues a message with the list of the disabled ORU(s), if applicable, to warn of any
throughput changes. You can confirm to run the current operation, or cancel it.

Reagent Area
Reagent Area Screen
Rack Representation

The reagent rack representation on the screen is:
NOTE:
l You may notice a slight resistance when inserting or removing racks. This is normal.
l Material #1 is at the top. Material #6 is at the bottom.
Reagent & Diluent Map

Displays the materials that are on-board. Columns in the screen represent the tracks where racks are inserted
on the instrument. Rows in the screen represent the positions in the rack.
R eagent A rea tab

Display on-board reagents.
D iluent A rea tab

Display on-board diluent materials.
A rrow buttons
Select the right and left arrows below the map to display more racks.

Reagent Area
Rack Warnings and Errors

The Reagent Area of the Control Module1 has a boxed area to the right that contains rack warning and error
messages and status indicators.

D escription field
Displays the errors and warnings issued for the materials placed on-board.
A uxiliary material status
Green – Cuvette waste door is open
Gray – Waste fluid status is OK

– Clean fluid status is OK
– Rinse fluid status is OK
– Cuvette waste status is OK
– Cuvette waste door is closed
Yellow – Waste fluid status is warning

– Clean fluid status is warning
– Rinse fluid status is warning
– Cuvette waste status is warning
– Cuvette loader status is warning
Red – Waste fluid status is full

– Clean fluid status is empty
– Rinse fluid status is empty
– Cuvette waste status is full or removed
– Cuvette loader status is empty
NOTE:
l When rinse or clean solutions reach a low level, a warning is issued.
l IL recommends daily visual monitoring of rinse and clean solutions.

Reagent Area
Reagent Rack Details Screen
This screen contains information for each placed bottle of reagent. Double-click the reagent rack to open the
Material N ame
Select browse ellipsis next to this field, or select the Add/Remove Material icon in the toolbar
to open the Materials window.

The first tab of the Materials window opens with the reagents that have been configured for selection. (See
Material Programming Window for configuring this window with reagents to select.) Additional tabs contain
additional material names from which you can select. Select one material name per rack position. A reagent
definition can be changed when the reagent is not placed.
Lot ID
Material lot ID. By default, the active lot ID is selected. If defined, you may select the alternate lot ID
instead.
Priority
The default priority is zero. Priorities are automatically assigned by the system. Typically, first bottle placed
is assigned priority 1, the second bottle placed priority 2, and so on. An exception is made for QC reagents
(see QC Reagents).
You may also assign a numeric priority value. Material positions with the highest priority are used first (for
example, priority 1). You cannot change priority when a warning or error condition is displayed.
NOTE: If you remove a reagent or diluent rack, you may lose priority settings upon reentry of the
rack into the instrument. See Working Information.
QC Reagents
When new vials of QC reagent are added to a rack that contains existing vials of the same QC reagent, and
the rack is reinserted within one hour, the instrument uses all the reagent in the older vials before using the
QC reagent in new vial.
Separate Priority with Same Material Placed On Two Sides of the Analyzer
Vial priority is set based on the ability of the reagent to be transported. For example, if four vials of Material
A are placed on the system (two on the Sample side, and two on the Reagent side) the two vials on the Sam-
ple side are assigned priority 1 and 2, and the two vials on the Reagent side are also assigned priority 1 and
2.

Reagent Area
For TOP 300 CTS, the diluent rack is accessible by the sample probe and reagent probe. However, priority
for reagents in the diluent rack is assigned to the sample probe. Reagents for the sample probe in the diluent
rack receive separate priority as identical reagents in reagent racks. When reagents in the reagent racks are
used up or expired, the reagent probe accesses the reagent in the diluent rack regardless of priority.
Expiration date
The reagent lot’s expiration date as established by the manufacturer.
W arnings and errors

List of warning and error message issued against the reagent in that rack position. Double-click this field to
display a window with the complete text of the message. Some possible messages are:
l Low material volume
l Empty material
l Lot not defined
l Material placement error
l Inconsistent bottle size
l Stability expired
l Material expiration
l Material not stirred
R emaining stability
The number of days, hours and minutes the reagent remains stable on-board the analyzer.
On-board volume
The current volume of reagent (in mL) on-board the analyzer.
R eagent color codes

On the far left of each reagent position is a colored circle that conveys additional information concerning the
reagent in that position, as follows:
Not placed Gray

Placed, not identified Green with a question mark
Placed, identified Green
Placed, warning Amber
Placed, error Red
In use Green surrounded by a heavy black circle
In use, warning Amber surrounded by a heavy black circle
In use, error Red surrounded by a heavy black circle
See Reagent Color Codes and LED Status Color Codes.

W orking information
The working information refers to the attributes of a bar coded reagent vial on-board. It is used by the system
to determine test feasibility and reagent on-board stability.
The vial bar code contains the material name, expiration date, lot number, and vial size.
If the reagent or diluent rack is removed from the instrument and replaced, the bar code scan determines
whether the reagent vial is the same as the vial that was removed. The working information of a vial (on-
board stability) is retained under the following conditions:
l The vial must be reinserted into the same position from which it was removed.
l The vial must be reinserted within one hour after removal.
l The volume of fluid in the reagent vial cannot change by more than 30%.
Offline or Virtual Rack

The rack to the far left in the Reagent Area represents an offline rack on your workbench. It is used to pre-pro-
gram reagents for a rack before inserting it into the analyzer. You can also program a rack after it has been
inserted, but it is often preferable to do it beforehand.
See Also
l Reagent Color Codes
l Test Feasibility
l Restriction Maps

Diluent Area
Diluent Area
Accessing the Diluent Area

To access the Diluent Area:
l Select the Diluent Area icon in the toolbar, or select Analysis > Diluent Area in the menu
bar.
l <300/500 CTS> Select the Reagent Area icon in the toolbar, or select Analysis > Diluent
Area in the menu bar.

Diluent Area
The diluent area includes the two right-most tracks in the sample area and the left-most track in the reagent
area. This area holds up to 24 calibration plasmas, QC materials, and dilution materials in original bottles
placed on diluent racks.
The sample arm aspirates and dispenses materials from diluent racks placed in the sample area. The reagent
arm aspirates and dispenses materials from the diluent rack placed in the reagent area.
The Diluent Area screen is functionally similar to the Reagent Area screen. The diluent area can accom-
modate three diluent racks (two tracks in the sample area and one in the reagent area). Each diluent rack can
hold two large bottles and six smaller bottles. The first two positions of the diluent rack can also be used for
4 mL, 10 mL, and 20 mL bottles, providing the correct adapter is inserted into the position on the rack. (See
Diluents.) The diluent rack representation on the screen is:
NOTE:
l Material #1 is at the top; material #8 is at the bottom.
l You may notice a slight resistance when you are inserting or removing racks. This is normal.

Diluent Area
Diluent Rack Details

This screen is identical to the Reagent Details screen. It contains information for each placed bottle of mate-
rial. Double-click the diluent rack in the Diluent Area screen that has focus to open the Rack Details screen.
See Also
l Reagent Area
l Sample Status Color Codes
l Restriction Map

Reagent/Diluent Area
This topic applies to TOP 500 CTS and TOP 300 CTS models. For TOP 700 (includes TOP Base), TOP 700
CTS (includes TOP CTS) and TOP 700 LAS models, see Reagent Area.
Overview
The Reagent/Diluent Area has diluent (D) tracks and reagent (R) tracks. The screen also displays an offline
rack for diluents on the left side, and an offline rack for reagents on the right side.
The Reagent/Diluent Area is cooled to 15° C ± 3°. Each reagent rack holds up to six 20 mL or 15 mL bot-
tles. You can also use 4 mL and 10 mL bottles with adapters. (See Sample Area, Reagents and Restriction
Map.) Positions #1 and #2 in each reagent rack provide stirring if you place a stir bar in the reagent bottle.
A clear cover placed over the area helps to reduce condensation.
Accessing the Reagent/Diluent Area and Rack Details

To access the Reagent/Diluent Area and Rack Details:
1. Select the Reagent Area icon in the toolbar, or select Analysis > Reagent Area in the menu
bar to open the Reagent/Diluent Area.
2. Double-click a position on the offline rack (located on the left side of the screen) to open the Reagent

Programming Non-Bar Coded Reagents Using the Offline Rack
1. Select the Reagent Area icon, or select Analysis > Reagent Area in the menu bar.
2. Double-click a rack to open the Rack Details screen.
3. Select a position in the rack, then select the Add/Remove Material icon to open the Materials
window with that rack position in focus.
4. Select a reagent button to place that reagent in the reagent rack position. (See Material Programming
Window for configuring this window with reagents to select.)
5. To program additional reagents on the rack, select a position and repeat the previous step.
6. When you have programmed all the materials on the rack, select the Insert Rack icon in the
toolbar.
7. Insert the rack into the instrument.

1. Select the Sample Area or the Reagent/Diluent Area icon in the toolbar to open the
Sample or Reagent/Diluent Area.
2. Select Actions >Review > Reagent & Diluent Map in the menu bar.
3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials.
4. Select the Reagent Area tab to view the on-board reagents.
5. Select the right and left arrows below the map to display more racks.

Reagent/Diluent Area Operations Toolbar
Restriction Map – Opens the Restriction Map. Also select Actions > Review > Restriction Map
in the menu bar.
Rack Details – Opens the Rack Details screen for the rack that has focus in the Reagent Area
screen.
Print – Prints a report that contains the following:

l State of all inserted racks with material placed on-board.
l State of on-board materials.
This report is useful when a maintenance activity is performed requiring removal of material racks.

Reagent Rack Details Operations Toolbar
Add/Remove Materials – Opens the Materials window where you select a reagent to add to the
reagent rack position in focus.
Clear rack information – Clears all reagents from the rack in focus.
Bar Code and Comments – Opens the Bar Code Edition dialog box where you can add a com-
ment about the rack position in focus.
Insert Rack – Inserts the rack into the instrument.
Print – Prints the rack details report for the rack displayed.
NOTE: After executing an operation:

l The instrument prompts you to abort and install a CTS filter if one is not detected. See Replace CTS
Filter and clean Clean Cup Area.
l The instrument issues a warning if an enhanced clean is required. You must perform the enhanced
clean before running any other operations. See Enhanced Clean in Performing Maintenance Activ-
ities.
l The instrument issues a warning if temperatures are out of range. You can confirm to run the current
operation, or cancel and wait until the temperatures are in range.

l The instrument issues a message with the list of the disabled ORU(s), if applicable, to warn of any
throughput changes. You can confirm to run the current operation, or cancel it.

Reagent/Diluent Area Screen

ACL TOP 300 CTS

ACL TOP 500 CTS
Rack Representation

The reagent rack representation on the screen is:
NOTE:
l You may notice a slight resistance when inserting or removing racks. This is normal.
l Material #1 is at the top. Material #6 is at the bottom.
Reagent & Diluent Map

Displays the materials that are on-board. Columns in the screen represent the tracks where racks are inserted
on the instrument. Rows in the screen represent the positions in the rack.
R eagent A rea tab

Display on-board reagents.
D iluent A rea tab

Display on-board diluent materials.
A rrow buttons
Select the right and left arrows below the map to display more racks.

Rack Warnings and Errors

The Reagent/Diluent Area has a boxed area to the right that contains rack warning and error messages and
status indicators:
D escription field
Displays the errors and warnings issued for the materials placed on-board.

A uxiliary material status
Green - Waste fluid status is OK

- Clean fluid status is OK
- Rinse fluid status is OK
- Cuvette waste status is OK
- Cuvette waste door is open
Yellow - Waste fluid status is warning

- Clean fluid status is warning
- Rinse fluid status is warning
- Cuvette waste status is warning
- Cuvette loader status is warning
Red - Waste fluid status is full

- Clean fluid status is empty
- Rinse fluid status is empty
- Cuvette waste status is full or removed
- Cuvette loader status is empty
Status Indicator on Physical Instrument
NOTE:
l The ACL TOP 300 CTS model does not have a status indicator for the waste fluid cuvette door or
cuvette waste.
l The rinse and clean fluid stations on the ACL TOP 300 CTS contain a single sensor position to indi-
cate when these solutions are low (Warning). Other ACL TOP models have a second sensor that indi-
cates when these solutions are empty (Error).

l When rinse or clean solutions reach a low level, a warning is issued. However, the ACL TOP 300
CTS model performs a controlled stop to prevent the solutions from becoming empty (Emergency
stop).
l IL recommends daily visual monitoring of rinse and clean solutions.

Reagent Rack Details Screen
This screen contains information for each placed bottle of reagent. Double-click the reagent rack to open the
Material N ame
Select browse ellipsis next to this field, or select the Add/Remove Material icon in the toolbar
to open the Materials window.

The first tab of the Materials window opens with the reagents that have been configured for selection. (See
Material Programming Window for configuring this window with reagents to select.) Additional tabs contain
additional material names from which you can select. Select one material name per rack position. A reagent
definition can be changed when the reagent is not placed.
Lot ID
Material lot ID. By default, the active lot ID is selected. If defined, you may select the alternate lot ID
instead.
Priority
The default priority is zero. Priorities are automatically assigned by the system. Typically, first bottle placed
is assigned priority 1, the second bottle placed priority 2, and so on. An exception is made for QC reagents
(see QC Reagents).
You may also assign a numeric priority value. Material positions with the highest priority are used first (for
example, priority 1). You cannot change priority when a warning or error condition is displayed.
NOTE: If you remove a reagent or diluent rack, you may lose priority settings upon reentry of the
rack into the instrument. See Working Information.
QC Reagents
When new vials of QC reagent are added to a rack that contains existing vials of the same QC reagent, and
the rack is reinserted within one hour, the instrument uses all the reagent in the older vials before using the
QC reagent in new vial.
Separate Priority with Same Material Placed On Two Sides of the Analyzer
Vial priority is set based on the ability of the reagent to be transported. For example, if four vials of Material
A are placed on the system (two on the Sample side, and two on the Reagent side) the two vials on the Sam-
ple side are assigned priority 1 and 2, and the two vials on the Reagent side are also assigned priority 1 and
2.

For TOP 300 CTS, the diluent rack is accessible by the sample probe and reagent probe. However, priority
for reagents in the diluent rack is assigned to the sample probe. Reagents for the sample probe in the diluent
rack receive separate priority as identical reagents in reagent racks. When reagents in the reagent racks are
used up or expired, the reagent probe accesses the reagent in the diluent rack regardless of priority.
Expiration date
The reagent lot’s expiration date as established by the manufacturer.
W arnings and errors

List of warning and error message issued against the reagent in that rack position. Double-click this field to
display a window with the complete text of the message. Some possible messages are:
l Low material volume
l Empty material
l Lot not defined
l Material placement error
l Inconsistent bottle size
l Stability expired
l Material expiration
l Material not stirred
R emaining stability
The number of days, hours and minutes the reagent remains stable on-board the analyzer.
On-board volume
The current volume of reagent (in mL) on-board the analyzer.
R eagent color codes

On the far left of each reagent position is a colored circle that conveys additional information concerning the
reagent in that position, as follows:
Not placed Gray

Placed, not identified Green with a question mark
Placed, identified Green
Placed, warning Amber
Placed, error Red
In use Green surrounded by a heavy black circle
In use, warning Amber surrounded by a heavy black circle
In use, error Red surrounded by a heavy black circle
See Reagent Color Codes and LED Status Color Codes.

W orking information
The working information refers to the attributes of a bar coded reagent vial on-board. It is used by the system
to determine test feasibility and reagent on-board stability.
The vial bar code contains the material name, expiration date, lot number, and vial size.
If the reagent or diluent rack is removed from the instrument and replaced, the bar code scan determines
whether the reagent vial is the same as the vial that was removed. The working information of a vial (on-
board stability) is retained under the following conditions:
l The vial must be reinserted into the same position from which it was removed.
l The vial must be reinserted within one hour after removal.
l The volume of fluid in the reagent vial cannot change by more than 30%.
Offline Racks
The racks to the far left and far right represent offline racks on your workbench. You can pre-program the dil-
uents on the left offline rack, or the reagents on the right offline rack before inserting them into the analyzer.
You can also program a rack after it has been inserted, but it is often preferable to do it beforehand. See Mate-
rial Identification.
NOTE: When loading sample, diluent, or reagent racks, pull the rack out all the way before loading.
Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in mis-

Diluent Rack Details Screen

This screen is functionally similar to the reagent Rack Details screen described in this topic.
The Diluent Area includes the 1-3 tracks, depending on the model. The diluent rack holds up to 8 cal-
ibration/NPP plasmas, QC materials, and sample dilution materials in original bottles placed on the racks,
or up to 8 intermediate reagents, deficient plasmas, reagent dilution materials. See Restriction Map and Test
Feasibility for placement.
Each diluent rack can hold two large bottles and six small bottles. The first two positions of the diluent rack
can be used for 4 mL, 10 mL, and 20 mL bottles when the correct adapter is inserted into the position on the
rack. (See Diluents.)
Rack Representation
The diluent rack representation on the screen is:
NOTE:
l Material #1 is at the top; material #8 is at the bottom.
l You may notice a slight resistance when you are inserting or removing racks. This is normal.
LED

See Also
l Test Feasibility
l Restriction Maps

Test Feasibility
Test Feasibility
Test Feasibility checks whether all the materials a selected test needs are available and usable.
Accessing The Test Feasibility List

To access the Test Feasibility List:
2. Select Actions > Review > Test Feasibility List in the menu bar, or select the Test Feasibility List
icon in the toolbar.

3. The Feasibility Test List window opens, where you can view information on the Test Feasibility List
and QC Feasibility List tabs.

Feasibility Test List window
Test Feasibility List Tab

Test C ode
Tests defined on the system.
General C onsistency
If checked, the test is feasible and can run.
General Feasibility
Feasibility status of normal and extended tests. A red X indicates the required materials are not placed in the
correct positions. A black number indicates the test is feasible and the materials have been correctly placed;
the number indicates the approximate number of tests that can run based on the usable volume of materials
on-board. A zero indicates an insufficient volume of material is loaded. A yellow number indicates the test
is feasible but there is no valid calibration for the on-board lots.
Clicking a cell in this column displays a window that lists: 1) name of each material required for the test; 2)
material type; 3) where the material should be placed on-board; and 4) approximate number of tests that may
run given the usable volume of material loaded. A red X in the # Tests column indicates the required material
is not placed, is incorrectly placed, or the reagent vial is empty. The following message appears in the Status
bar: Job not feasible: Needed materials not placed, incorrect placement or empty volume.

Test Feasibility
NOTE: The numbers displaying how many tests are feasible are approximate, and should be used
only as a guide.
Required materials may include some or all of the following, depending on what has been defined:
l Load cycle reagents
l Load cycle sample diluents
l Load cycle reagent diluents
l Clean materials for load cycle materials
l Predilution diluent
l Predilution diluent clean
l Rerun predilution diluent
l Rerun predilution diluent clean.
Parallelism Feasibility
All tests for which parallelism has been defined have either a red X or a number. A red X indicates the
required materials are not placed in the correct positions. A black number indicates the test is feasible and
the materials have been correctly placed; the number indicates the approximate number of tests that can run
based on the usable volume of materials on-board. A zero indicates an insufficient volume of material is
loaded. A yellow number indicates the test is feasible but there is no valid calibration for the on-board lots.

C alibration Feasibility
All tests for which calibration has been defined and do not use an imported calibration have either a red X or
a number. A red X indicates the required materials are not placed in the correct positions, or there is no val-
idated calibration for the on-board lot. A black number indicates the test is feasible and the materials have
been correctly placed; the number indicates the approximate number of tests that can run based on the usable
volume of materials on-board. A zero indicates an insufficient volume of material is loaded.
QC Feasibility
See QC Feasibility List tab.
A check mark in this field indicates QC for this test is feasible; all materials (reagents and controls) are cor-
rectly placed and have sufficient volume.
A partial (gray) check mark (see Grid Icons) indicates some of the materials do not have sufficient volume to
run the test. QC can run using the controls that are present in sufficient volume.
A red X indicates QC is not feasible.
N PP Feasibility
All tests for which NPP1 has been defined have either a red X or a number. A red X indicates the required
materials are not placed in the correct positions. A black number indicates the test is feasible and the mate-
rials have been correctly placed; the number indicates the approximate number of tests that can run based on

Test Feasibility
the usable volume of materials on-board. A zero indicates an insufficient volume of material is loaded. A yel-
low number indicates the test is feasible but there is no valid calibration for the on-board lots.

QC Feasibility List Tab
Test C ode
Lists all tests for which QC has been defined.
Material name
Lists all the QC controls defined for the test.
QC Feasibility
Number of QC tests that can run with the usable volume on-board. Clicking a cell in this column displays a
window that lists: 1) name of each material required for the test; 2) material type; 3) where the material
should be placed on-board; and 4) approximate number of tests that may run given the usable volume of
material loaded. A red X in the # Tests column indicates the required material is not placed, is incorrectly
placed, or the reagent vial is empty. The following message appears in the Status bar: Job not feasible:
Needed materials not placed, incorrect placement or empty volume.

Test Feasibility
Refresh/Close
Click the Refresh button to refresh the contents of the window and the Close button to close the window.
LAS Test Feasibility

See Also
l Material Definition – Smallest Volume


CHAPTER 6 Starting and Stopping the Instrument
CHAPTER 6
STARTING AND STOPPING THE INSTRUMENT
Starting and Stopping Overview

To start or stop the instrument, select one of the following:
l Shutting Down the Instrument
l Emergency Stop
l Controlled Stop
l Recovery

Chapter 6 – Starting and Stopping the Instrument
Starting the Instrument

To start the instrument:
1. Make sure the access cover is closed.
2. Power on the CM1.
3. Power on the AM2 using the On/Off switch on the right side of the analyzer.
4. Double-click the ACL TOP icon on the desktop.

5. Log onto the ACL TOP instrument.
See Recovery for starting the instrument after an emergency stop.
The analyzer mechanical initialization process takes about three minutes. After initialization, the AM enters
the Adjusting Thermal state to regulate all thermally controlled devices.
The time for the AM to reach specified temperature (Power-Up to Ready) with empty sample and reagent
modules takes approximately 30 minutes at a nominal operating temperature of 25° C. At the extreme oper-
ating temperatures of 15° C and 32° C, it takes approximately 60 minutes with empty sample and reagent
modules.
NOTE:
l A rinse flow verification test is performed automatically by the instrument at the end of mechanical
initialization. However, it does not start if the cuvette loader is Empty or if there is a Rinse Bottle
Empty error or Low warning. If a probe fails this test (each probe can retry one additional time), a
Rinse Flow Test Failure message appears.
l If any probe coordinates files are missing, the instrument status changes from Initializing to Error, and
you must select System > Diagnostics > Probes and perform the coordinates adjustment for the
affected arm(s) before the instrument can complete initialization. When you exit Diagnostics, mechan-
ical initialization is performed automatically by the instrument. See Probes/Coordinates Adjustment.
The time required to stabilize depends on the ambient temperature and initial conditions of the system.
The system is ready to use when the status LED is green and the CM displays Ready.
Normally, the instrument is kept running continuously. Automatic maintenance procedures such as periodic
fluidic priming cycles ensure that the system is Ready for analysis at all times.
See Also
l Starting and Stopping Overview

Shutting Down the Instrument
Shutting Down the Instrument

To shut down the instrument:
1. Make sure the AM1 in the Ready state.
2. Select Instrument > Exit in the menu bar.
3. Select OK in the confirmation dialog box. The AM begins an abbreviated mechanical initialization to
place the analyzer into a known safe state.
4. At the conclusion of the mechanical initialization, turn off the AM. The switch is located on the right
side of the analyzer.
5. Shut down the CM2 according to standard Windows procedures.
See Also
l Emergency Stop
l Controlled Stop
l Recovery

Emergency Stop
An emergency stop immediately terminates all operations and motion on the Analyzer1. An emergency stop
can be performed when the instrument is in any state except Not Connected, even when no user is logged on.
To perform an emergency stop
l Press the red emergency stop button on the front of the Analyzer.
See Also
l Emergency Stop
l Controlled Stop
l Recovery

Controlled Stop
Controlled Stop
The Instrument > Controlled Stop menu command stops the ACL TOP instrument from processing new sam-
ples. This is a user-initiated controlled stop as opposed to the instrument-initiated controlled stop. These two
operations are the same. They complete samples that have started testing, then return the Analytical Module1
to the READY state. Tests that had not started when the controlled stop initiated return to the PLACED
state.
Performing a Controlled Stop

To perform a controlled stop:
1. Select Instrument > Controlled Stop in the menu bar.
2. Select OK on the confirmation dialog box.
NOTE: If you select Cancel or close the confirmation dialog box without selecting OK, the con-
trolled stop request is canceled.
TOP 700 LAS Controlled Stop

Since the ACL TOP 700 LAS system has Auto Run always enabled, you need the ability to stop processing
samples at any time. The LAS Controlled Stop choice on the Instrument menu stops processing new samples.
This is a user-initiated controlled stop. If selected while the instrument is in the BUSY state, it allows the
tests that have already started to complete. Tests that had not started when the LAS Controlled Stop was ini-
tiated return to the PLACED state.
When the ACL TOP 700 LAS status is Stopped the following applies:
l New tubes from the LAS track are rejected.
l No new aspirations are performed.
l The sample tube currently in use is held at the track aspiration point.
Performing a Controlled Stop on an ACL TOP 700 LAS Instrument

To perform an LAS Controlled Stop:
1. Select Instrument > LAS Controlled Stop in the menu bar.
2. Select OK on the confirmation dialog box.
NOTE: If you select Cancel or close the confirmation dialog box without selecting OK, the
controlled stop request is canceled.
3. After the LAS controlled stop completes, do one of the following to start a new analytical session and
reactivate the autorun function. The instrument status will change from Stopped to Ready.
l Select Instrument > Resume Auto Run in the menu bar.

l Select the Run icon in the toolbar.

l Select Actions > Map > Run Tests in the menu bar.
See Also

Resume Auto Run
Resume Auto Run

To re-start autorun after a controlled stop:
l Select Instrument > Resume Auto Run in the menu bar.
The Auto Run status changes to Ready and the autorun function starts again.

Recovery
Recovery reinitializes the system and returns the instrument to the Ready state after an emergency stop.
Overview
After an emergency stop occurs and recovery is performed, the sample and reagent rack information is
retained when both of the following conditions are met:
l The bar code reader is not moved.
l The covers are not opened during the emergency stop.
After recovery, select the Run icon in the toolbar to run tests on samples in the To Do state.
LA S
On the TOP 700 LAS model, after an emergency stop has occurred and recovery is initiated, the Analytical
Module1 notifies the Control Module2 of all cuvettes detected in the LAS aspiration area, the LAS holding
area, and in the shuttle. Only cuvettes with successfully aspirated sample and tests programmed are restored.
Cuvettes that are empty or have partially aspirated samples are not restored and are eventually moved to the
cuvette waste.
Performing a Recovery Operation

To perform recovery:
1. <Optional> To retain sample and reagent rack information, do not move the bar code reader or open
the instrument covers while the instrument is in the emergency stop.
2. Select Instrument > Recovery in the menu bar.
3. If the bar code reader was moved or the covers opened during the emergency stop, remove the racks
and reinsert them into the instrument to restore sample and reagent rack information that was lost dur-
ing recovery.
Performing a Forced Recovery

Use this procedure if the instrument stalls.
To perform a forced recovery:
1. <Optional> To retain sample and reagent rack information, do not move the bar code reader or open
the instrument covers while the instrument is in the emergency stop.
2. Press the emergency stop button on the front of the instrument.
3. Select Instrument > Recovery in the menu bar.

Recovery
4. If the bar code reader was moved or the covers opened during the emergency stop, remove the racks
and reinsert them into the instrument to restore sample and reagent rack information that was lost dur-
ing recovery.
See Also


CHAPTER 7 Calibration
CHAPTER 7
CALIBRATION
Calibration Details
Overview
Calibration allows for the conversion of a measured value (raw data) to a value expressing units of con-
centration or activity of the analyte. The analyzer makes dilutions, adds reagents, and takes readings, then
generates a calibration curve.
After a calibration is complete, you can review the calibration results and manually validate them so they can
be used to calculate sample results. When you validate a calibration, you confirm that the calibration results
are valid for a particular lot of calibrator1 and reagent. You can also autovalidate the calibration results. See
Auto Validation Setup
The ACL TOP instrument can store the ten most recent calibrations, but only one calibration can be val-
idated at any time. After the 11th calibration runs, the oldest calibration is removed from the Calibration
Details screen. The validated calibration is never removed.
NOTE: If you change the parameters of a user-defined test so the analytical performance of that test
is affected, you must recalibrate that test.

Chapter 7 – Calibration
Reviewing and Validating Calibration Test Results

To review and validate calibration test results:
1. Select Calibration > Status List in the menu bar.
2. In the Calibration Status List, double-click a test code, or select a test code and select the Cal-
ibration Details icon to open the Coagulation Calibration Details screen.

By default, the Calibration Details screen opens displaying the validated calibration. If a test has no
validated calibration, the Calibration Details screen displays Calibration 1.
3. Select the Calibration Curve tab to view the calibration curve and results for the various dilutions.
4. Select the Calibration Information tab to view calibration status information.
5. Select the Reactions Information tab to view the reaction curves for each point on the calibration
curve as well as errors and warnings for specific data points.
6. Select the Tracking Information tab to view lot specific information for the materials used and a log of
all comments related to the calibration.
7. To add or edit a comment in the Tracking Information tab, select the Comments icon in the tool-
bar. The system also prompts you for comments after you make any edits in the Coagulation Cal-
ibration Details screen.
8. To validate a calibration, select the tab with the calibration to validate (e.g., Calibration 1, 2, etc.),
and select the Validate icon in the toolbar. The calibration data is stored in the system and is
used to calculate calibrated results for future tests. Validation is not possible if any calibration check
fails.
9. To recalculate a calibration, select the Recalculate Calibration icon. This replots the cal-
ibration curve according to the current test and material definitions. When recalculating calibration
results, the system uses the calibrator lot number used during execution. If the lot number does not
exist or the proper assigned values are not accessible, the recalculation fails. See Reviewing Test
Results.
11. Select the Previous Screen icon in the toolbar to return to the Calibration Status List.
NOTE:
l If the calibration result has a warning and you validate the result despite the warning, that warning is
not posted to the sample results. You are responsible for acknowledging the warning and ignoring it.
l Failed calibrations may not be validated.

Calibration Details
Viewing Calibration Curves

To view a curve in the Calibration Curve tab:
1. Open a test in the Coagulation Calibration Details screen.
2. Select the Calibration Curve tab or Reactions Information tab.
3. Double-click the point value in the Replicate column.
4. Double-click the curve to enlarge the window.
5. Select Actions > Configuration > Multiple Math Model View in the menu bar to display a cal-
ibration curve that is a combination of two curve segments. A solid vertical line shows the point in
the curve at which the math model segments meet.
6. To view each segment individually, select Actions > Configuration > Math Model High View or
Math Model Low View in the menu bar.
The Multiple Math Model View is the default view. The selected view is named in the title bar.
Deleting a Calibration Point Value

To delete a calibration point value:
2. Select the Calibration Curve tab or Reactions Information tab.
3. In the table of data point values, double-click the point value you want to delete in the Replicate col-
umn.
4. Select the point value in the table again to highlight it.
5. Press the Delete key on the keyboard.
6. Click elsewhere on the tab screen to see the curve with the deleted value. A deleted point value
appears in the table as parentheses, and in the calibration curve as an X.
7. To restore the deleted point value before saving, select Actions > Calibration > Restore in the menu
bar.
9. To restore the deleted point value after saving, select the Recalculate Calibration icon. This
replots the calibration curve according to the current test and material definitions. When recalculating
calibration results, the system uses the calibrator lot number used during execution. If the lot number
does not exist or the proper assigned values are not accessible, the recalculation fails. See Reviewing
Test Results.

Printing and Exporting a Calibration Report

To print or export a calibration report for a completed test:
2. Select the Print icon in the toolbar, or select Actions > Print in the menu bar.
3. To export the calibration report, select Export Actions > Print in the menu bar. See Exporting Data.
C alibration R eport
A calibration report includes the following information:
l Test code
l Calibration unit
l Date and time performed
l Date and time validated
l Calibrator materials (up to eight are listed)
l In case of manually diluted calibrations, all calibrator materials are listed including:
o Diluent name
o Validation status
o Calibration status
o Master calibration test code
l Result information including:
o Regression type
o X-Axis transformation
o Y-Axis transformation
l Calibration factors including:
o Y Intercept
o Slope
o r2
o Errors and warnings

l For each concentration the following is printed:
o Concentration if automatic pre-dilution is used
o Calibrator material if manual pre-dilution is used
o Concentration – assigned value
o Concentration – CV%
o Concentration – mean value

Calibration Details
o Replicate value (printed once for each replicate up to a maximum of 6) – If a replicate value is
a detected value, it is displayed in brackets [ ]. If it is an edited value, it appears on the report
in bold characters. If it is an omitted value it is displayed in braces { }.

Calibration Details screen
Calibration Curve Tab
This tab contains important information to help you decide which calibration to validate.
NOTE: The X-axis is calibrated from the smallest measured value, not from zero.
Calibration Statistics
Slope
If the Slope Check option is enabled for the test, this value is checked to verify that the curve falls within the
acceptable slope range.
R 2 Value
If the R2 Check is enabled for the test, this value is checked to verify that the curve falls within the accept-
able R2 range.
Y-Intercept
If the Y-Intercept Check has been enabled for the test, this value is checked to verify that it falls within the
acceptable y-intercept range.

Calibration Details
A djusted Y
Part of the calibration slope calculation for the linear regression math model only. If the slope cannot be cal-
culated, the Y-Intercept field is blank.
N PP
If NPP mode is enabled and the mode is Derived from Calibration, the NPP measured result is displayed
(mean value of replicates of the selected calibration dilution).
N PP Value
If NPP mode is enabled, and the mode is Derived from Calibration, the NPP1 calibrated result is displayed
(target value of the selected calibration dilution).
Enable Display Transformed Axes

Option to enable toggling between the current calibration graph display mode (no axis transformation, x =
time and y = measured unit) and the transformed axes mode. See Viewing Calibration Curves.
Point Value Table Column Headings
C alc. Value
Calculated value for the mean of each calibration dilution.
%C V
CV calculated for the replicates of a dilution. If the Enable %CV Check option is enabled, this value is
checked to verify that it is less than the maximum %CV allowed. %CVs greater than the maximum allowed
CV are displayed in red text. This value is not reported if the level has less than 3 replicate values.
Mean Value
Mean of the replicates for a dilution.
Multiple Math Model

For factor tests having multiple math models using polynomial equations defined for the calibration, the Cal-
ibration Curve tab screen shows the polynomial coefficients as exponents. See Viewing Calibration Curves.

C alibration R esult with Math Model H igh

Calibration Details
Calibration Information Tab
Displays important status information about the calibration, including the following:
l Test execution date/time
l Validation status
l Validation date/time
l Errors and warnings – QC overdue or failed, Maintenance overdue or failed, Results recalculated
l Other general information.

Reactions Information Tab
Displays the following:

l Reaction curves for each point in the calibration curve
l Errors and warnings specific to that data point. (Temperature errors and warnings are flagged only on
replicates, not on the test as a whole.)
To view the reaction curve for a particular dilution replicate:
1. Double-click the value in the Replicate column.
2. Double-click the reaction curve to enlarge the window.
No reaction curve is displayed for points that are manually edited.

Calibration Details
Tracking Information Tab
Displays the following for the active or alternate lot material used for the test selected in the Calibration
Status List:
l Material name
l Lot number
l Expiration date
l Comments log for the calibration
Comments
You can view and enter comments in the Comments field. Comments contain Time, Date, and User ID. See
Viewing Calibration Curves.

See Also
l Calibration Setup
l Auto Validation Setup


Accessing the Calibration Status List
To view the Calibration Status List:
2. To print a Calibration Status List, select the Print icon in the toolbar.
3. To export the Calibration Status List Report, select Actions > Export in the menu bar.
4. See Calibration Details.

Calibration Status List screen
This screen contains the following status information for tests with calibration enabled and defined:
l Test Code
l Calibrator
l Job Status
l Unit
l Frequency Status
l Overdue Date and Time
l Last Validated
l Frequency
l Last Completed
See Also
l Calibration Setup

Performing a Calibration
Performing a Calibration
Before Programming a Calibration
The following conditions must be met before programming a calibration.
1. Define the calibration materials. See Calibration Setup.
2. In the Test Definition screen, define the calibration units. See Result Unit Definition.
3. Place all reagents, diluents and calibrators in the appropriate positions on the instrument. See Restric-
tion Map.
Programming a Calibration in the Calibration Details screen

Use this procedure when working with calibrator1 material placed in the original bottle on a diluent rack
inserted into a diluent track in the Sample Area (track D1 or D2).
NOTE: When a calibration is programmed in the Calibration Details screen and the test is not fea-
sible because the calibration plasma has expired, the instrument uses calibration plasma from other placed bot-
tles, taking first from an active lot placed in track D1, then from an alternate lot placed in track D1.
1. Make sure the required conditions are met.
3. In the Calibration Status List double-click a test, or select a text and select the View icon in
the toolbar.
By default, the Calibration Details screen opens displaying the validated calibration. If a test has no
validated calibration, the Calibration Details screen displays Calibration 1.
4. Select the Program icon in the toolbar, or select Action > Calibration > Program in the
menu bar.
NOTE: After selecting the run command, the following apply:

forming Maintenance Activities. .
l A new calibration test cannot be programmed if it is running or scheduled to run.

Programming a Calibration in the Sample Rack Details screen

Use this procedure when working with calibrator material placed in a sample container on a sample rack.
1. Select the Sample Area icon in the toolbar, or select Analysis > Sample Area in the menu
bar.
2. Select the Rack Details icon in the toolbar to open the Rack Details screen for the appropriate
rack.
3. Select Cal/NPP in the Sample Type drop down list.
4. Select a material in the Sample ID drop down list.
5. Select the Cal1 option beside the Sample ID list.
6. If lot management is enabled, select the Active Lot or Alternate Lot button.
7. Select the Add/Remove Tests icon to open the Tests and Profiles dialog box.
8. Double-click one or more test cells on the right side of the screen and select tests in the Test Pro-
gramming Window to add to the Rack Details screen. See
9. Select the Run icon in the toolbar.

You can now Review and Validate calibration results.
See Also
l Calibration Setup
1Calibrator. A type of sample with an assigned value used to calibrate a test.

CHAPTER 8 Normal Pool Plasma
CHAPTER 8
NORMAL POOL PLASMA
NPP Status Details
Overview
Normal Pool Plasma (NPP) is a type of sample used to generate a standard value that is used to calculate ratio
and INR1 results. The ACL TOP instruments use calibration data, normal range data, or NPP sample data to
generate an NPP value.
NOTE: If the measured result is 0, the Ratio and INR results fail.
The ACL TOP instrument stores the five most recent NPP results per test. After the sixth NPP sample is run,
the oldest NPP data is removed from the NPP Details screen.
Reviewing NPP Results

To review status and NPP test results:
1. Select NPP > Status List in the menu bar.
2. <Optional> Click a column to sort the NPP Status List by ascending or descending order.
3. Do one of the following to open the NPP Details screen.
l Double-click a test in the list.
l Place focus on the test code and select the NPP Details icon.
l Select Actions > Review > NPP Details in the menu bar.
4. Select the General Information tab to view important status information about the NPP.
5. Select the Reaction Information tab to view the reaction curves, result values, and errors and warn-
ings for each NPP replicate.
6. Select the Tracking Information tab to view lot information for the NPP material and the comments
log.
worldwide.

Chapter 8 – Normal Pool Plasma
Recalculating NPP Test Results

To recalculate the results of the NPP test displayed in the active tab:
1. Make sure the NPP test has completed.
2. Open the test in the NPP Details screen.
3. Select the Recalculate Results icon, or select Actions > NPP > Recalculate in the menu bar.
The NPP test results update after the operation completes. This operation uses the current validated cal-
ibration with the same lot number.
NOTE: When recalculating results, the system uses the ISI value from the lot that matches the mate-
rial used during the test. If the lot used during test execution is no longer in the system, or the current mate-
rial with ISI value was not used during the execution, the INR result fails. See Reviewing Test Results for
information on recalculation.
Printing an NPP List Report

To print an NPP List report:
1. Select NPP > Status List.
2. Select Actions > Print in the menu bar, or select the Print icon.
An NPP List report includes the following information:
l Test code
l NPP material
l NPP unit
l Frequency status
l Overdue date and time
l Frequency, including:
o Automatic execution enabled
o Last executed date and time

NPP Status Details
Printing an NPP Results Report

To print an NPP Results report:
1. Select NPP > Status List.
2. Double-click a test in the NPP Status List, or select Actions > Review > NPP Details in the menu bar
to open the NPP Details screen.
3. Select Actions > Print Screen in the menu bar, or select the Print icon.
An NPP Results report includes the following information:
l Test code
l NPP material
l Frequency status
l Rack ID
l Position
l Date and time performed
l Errors and warnings
l For each replicate the following information is included:
o Measured value + Measured unit
o Calibrated value + Calibrated unit
o Replicate errors
o Reaction curve
l Test tracking information
Exporting a Report
To export a report:
2. Double-click a test in the NPP Status List to open the NPP Details screen.
3. Select Export to export the NPP List report or the NPP Results report.
4. In the Export dialog box, select the format and destination in the respective fields.
5. Click OK.
See Exporting Data.

NPP Status List Screen

The NPP Status List contains current status information for tests that are NPP-enabled and defined exclu-
sively as NPP Run as Sample. The table contains the following columns:
l Test Code
l Material
l Job Status
l Unit
l Frequency Status
l Overdue Date and Time
l Frequency
l Auto Execution Mode

l Last Completed

NPP Status Details
NPP Details Screen

General Information Tab
Displays the following NPP status information:

l Test execution date/time
l Validation status
l Validation date/time
l Errors and warnings
l Other general information
Reaction Information Tab

Displays the reaction curves, result values, and errors and warnings for each NPP replicate.

Displays the following NPP material information:
l Material name
l Lot number
l Expiration date
l Comments log
See Also
l Normal Pool Plasma Setup
l Performing a Normal Pool Plasma Measurement
l Accessing Data Flags

Performing a Normal Pool Plasma Measurement

An NPP test can run as follows:
l In the Sample Rack Details screen
l In the NPP Details screen
l Automatically by the system if the NPP mode is set to Run as sample.
Before You Begin NPP

1. Define the NPP materials for the test. See Normal Pool Plasma Setup.
2. In the test definition, set the NPP mode to Run as Sample. See Normal Pool Plasma Setup.
3. Place the NPP materials in the appropriate positions on the analyzer. See Restriction Map.
Programming an NPP in the NPP Details screen

Use the NPP method when working with NPP material placed in its original bottle on a diluent rack inserted
into a diluent track in the Sample Area (track D1 or D2).
NOTE: If the NPP material has expired, and the NPP is run from the NPP Details screen, the instru-
ment uses NPP material from other placed bottles, taking first from an active lot placed in track D1 or D2,
then from an alternate lot placed in track D1 or D2.
3. Double-click a test.
4. Select the Program icon.

l A new NPP test cannot be programmed if it is running or scheduled to run.

Performing a Normal Pool Plasma Measurement
Programming an NPP from the Sample Rack Details screen

Use the NPP method when working with NPP material placed in a sample container on a sample rack.
bar.
2. Select the Rack Details icon in the toolbar to open the Rack Details screen for the appropriate
rack.
3. Select Cal/NPP in the Sample Type drop down list.
4. Select a material in the Sample ID drop down list.
5. Select the NPP1 button beside the Sample ID list.
6. If lot management is enabled, select the Active Lot or Alternate Lot button.
7. Select the Add/Remove Tests icon in the toolbar to open the Tests and Profiles dialog box.
8. Double-click one or more test cells on the right side of the screen and select tests in the Test Pro-
gramming Window to add to the Rack Details screen.

Automatic NPP
If Automatic NPP is enabled for the test, the system automatically performs an NPP measurement when the
user-defined frequency interval expires. To enable Automatic NPP, see Normal Pool Plasma Setup.
NOTE: Automatic NPP can only be performed using NPP material placed on a diluent rack inserted
into a diluent track in the sample area (track D1 or D2).


CHAPTER 9 Quality Control
CHAPTER 9
QUALITY CONTROL
QC Overview
The ACL TOP instrument provides a quality control (QC) program that allows you to monitor performance
characteristics of an analytical system for precision and accuracy as well as alert you to sources of unac-
ceptable analytical performance.
QC definitions must be set up before performing QC. See QC Setup Definition.
QC Performed on Alternate Lots

QC may be performed on alternate lots of QC materials to establish a new control range while the original
material is processed. After a sufficient number of control determinations has been performed, the alternate lot
can be activated. Alternate lot results are not used to flag patient sample results. The result data points may
be displayed on the Levey-Jennings chart in a different color than the active lot result data points. See
Reviewing QC Results.
When the alternate lot has been automatically activated the following occurs:
l The lot information is copied from the alternate lot to the active lot.
l The existing active lot data is archived.
l The alternate lot fields are set to their default values.
l The alternate lot is disabled.
Activating an Alternate Lot

To activate an alternate lot:
1. Select QC > Results List in the menu bar.
2. Double-click a material name or test code in the results list.
3. Select the Activate Lot icon in the toolbar, or select Actions > QC > Activate Lot in the menu
bar.
See Also
l Quality Controls
l QC List
l QC Profiles List

Chapter 9 – Quality Control
l QC Results List

QC Results List
QC Results List
The QC Results List screen displays the results obtained from the most recent QC measurement.
Accessing the QC Results List

To access the QC Results List:
2. Double-click a test code in the QC Results List to view the associated QC statistics.
3. See Reviewing QC Results.
QC Results List
The QC Results List displays the results obtained from the most recent QC measurement. It contains the fol-
lowing information for tests that have QC enabled and defined:
l Test Code – Unique test code for the test.
l Material Name – Name of material as defined in the Material Definition.
l Last QC Results – Numeric result of the last QC run.
l Unit – Unit for the last QC run.
l Last QC Job Status – Status of the last QC job run for that point. Status can be PASSED, FAILED or
OMITTED.
l Target Mean – Expected mean as defined in the Material Definition. See Assigned Values.
l Target SD – Expected standard deviation as defined in the Material Definition. See Assigned Values.
l Cumulative Statistic Mean – Mean value of all QC points for the active lot.
l Cumulative Statistic SD – Standard deviation for the active lot.
l Cumulative Statistic N – Number of points used to determine the mean and standard deviation of the
active lot.
NOTE: To change the cumulative statistics for the QC results list, change the active lot or per-
form a QC purge.
l Frequency Status – Frequency status of the QC test as defined in the QC Setup Definition. Status can
be OVERDUE, DUE or no status. If frequency is not configured, this field is blank. This column is
different from the Frequency Status column in the QC Test Status List screen. It is used to display the
last QC status for this test.
l Time to Overdue – The time when a QC is expected to become overdue, as defined in the QC Setup
Definition.
l Tests to Overdue – The number of tests at which a QC is expected to become overdue, as defined in
the QC Setup Definition. You must have frequency By tests enabled to have a value in this column.
l Auto Execution Mode – A check mark indicates automatic execution is enabled in the QC Setup
Definition.

conditions are met:
NOTE: If Automatic execution of a QC job By Absolute Time is selected in the QC

Setup Definition, and Auto Run is selected in Global Definitions Setup, QC automatically
executes the QCs at the defined times if the following conditions are met:
l Active Lot/Lot ID – Lot ID of the active lot.

l Active Lot/Expiration Date – Expiration Date of the active lot.
l Enabled Alternate Lot – A check mark indicates the alternate lot is enabled in the Material Def-
inition.
NOTE:
o Running a QC on an alternate lot does not reset the frequency status.
o Running a QC on an alternate lot results in a blank QC status. Results are not eval-
uated for alternate lots.
See Also
l Quality Controls
l QC Overview
l QC List
l QC Profiles List

QC Test Status List
QC Test Status List
Accessing the QC Test Status List

To access the QC Test Status List.
1. Select QC > Test Status List in the menu bar.
2. See Reviewing QC Results.
QC Test Status List screen

The QC Test Status List screen contains the following status information for tests that have QC enabled and
defined.
Test Code – Unique test code for the test.
Active QC Lot Status – Overall status of the active QC lot.
Frequency Status – Frequency status of the QC test as defined in the QC Setup Definition. Status can be
OVERDUE, DUE or no status. If frequency is not configured, this field is blank. Applies to an active QC lot
only. Does not apply to alternate QC lots.
NOTE: The frequency status in the QC Test Status List screen is different from the QC
Results List screen frequency status as follows:
o If all defined QCs are OK, the test frequency status is OK.
o If any QC test has an overdue status, the test frequency status is Overdue.
o If no QC test is overdue and there is at least one QC test that is due, the test frequency
status is Due.
Time to Overdue – The time when a QC is expected to become overdue, as defined in the QC Setup Def-
inition.
Tests to Overdue – The number of tests at which a QC is expected to become overdue, as defined in the QC
Setup Definition. You must have frequency By tests enabled to have a value in this column.
Last QC Material – Lot number of the last QC material result for the test code.
Last Completed QC – Date and time stamp at completion of the last QC result for the test code.
See Also
l Performing a Quality Control Test
l Quality Controls
l QC Overview
l QC List
l QC Profiles List

l QC Results List

Performing a Quality Control Test

Before You Begin A Quality Control Task
1. Define and enable the quality control materials for the test. See QC Setup Definition.
2. Place the QC materials correctly on the instrument. See Restriction Map.
Programming QC in the QC Test Status List

Use this procedure when working with QC materials placed in the original bottles on a diluent rack inserted
into a diluent track in the Sample Area (track D1 or D2).
NOTE: When QC is programmed in the QC Statistics screen and the test is not feasible because the
QC material has expired, the instrument uses QC material from other placed bottles.
To program QC in the QC Test Status List:
3. In the QC Test Status List, double-click a test, or select1 a test and select the QC Statistics
icon in the toolbar. The QC Statistics screen opens.
4. Select the Material/Test View icon in the toolbar to toggle the view in the Material/Tests Def-
inition Tree between Tests > Material and Material > Tests mode.
Material/Tests Definition Tree
one object.

5. Select the Material/Test View icon in the toolbar to toggle the tree view to the desired con-
figuration.
l If the tree is organized by Material > Tests, when you check a material, all the QC
tests related to that material are added to the Program QC list. Click the check box
again to deselect it, or select the Clear QC Selection icon to deselect every-
thing.
l If the tree is organized by Tests > Material, when you check a test, all the QC mate-
rials related to that test are added to the Program QC list. Click the check box again to
deselect it, or select the Clear QC Selection icon to deselect everything.

6. <Paired Tests> Make sure both tests (master and paired) are feasible.
l If the master test is not feasible, and the paired test is feasible, the master test does not
run and the paired test fails.
l If the master test is feasible, and the paired test is not feasible, the master test runs and
produces results, but the paired test does not run.

7. Select one or more tests or materials in the Tests/Material Definition tree.
8. To select one or more QC profiles to run, select the Select QC Profiles icon in the toolbar.
Then select the QC profiles in the Select multiple QC profiles dialog box, and click OK. The tests in
those profiles appear selected in the tree.
9. Select the Program icon in the toolbar to run the QC tests . See Reviewing QC Results.

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to
abort running the test. You must perform the enhanced clean before running the test.
See Enhanced Clean in Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run com-
mand or cancel and wait until temperatures are in range.
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning
about throughput changes. Confirm or cancel the run.
l A new QC test cannot be programmed if it is running or scheduled to run.
l If QC is not feasible, a message prompts you to view feasibility detailed information.
See Test Feasibility.
10. When the QC tests are complete, the QC Statistics screen for each material/test combination updates
with the result information. See Reviewing QC Results.

Programming QC in the Sample Rack Details screen

Use this procedure when working with a QC material placed in a sample container in a Sample Rack.
NOTE: This method does not use bar codes. Therefore, volume warning, on-board stability tracking,
and expiration date tracking cannot be used.
To program QC in the Sample Rack Details screen:
bar.
2. Place the QC controls into sample cups on a sample rack.
3. Insert the sample rack onto the analyzer.
4. Place focus on the rack with the QC controls and select the Rack Details icon in the toolbar to
open the Rack Details screen.
5. Select the rack position.
6. In the Sample Type drop down list, select Quality Control.
7. In the Sample ID drop down list, select the material.
8. If lot management is enabled, select the Active lot or Alternate lot button.
9. Select the Add/Remove Tests icon in the toolbar to open the Tests and Profiles dialog box.
10. Click the appropriate tests to populate the Rack Detail screen.
NOTE: After selecting the program command:

l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to
abort running the test. You must perform the enhanced clean before running the test.
See Enhanced Clean in Performing Maintenance Activities.
l If the temperature is out of range, the instrument prompts you to confirm the run com-
mand or cancel and wait until temperatures are in range..
l The instrument prompts you with a list of the disabled ORUs, if any, as a warning
about throughput changes. Confirm or cancel the run.
CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the
way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or
sample cups may result in misidentification of rack contents.

Enabling Automatic QC
If Automatic QC is enabled for a test, the system automatically performs QC when the user-defined frequency
expires.
To enable automatic QC:
l See QC Setup Definition.
NOTE: Automatic QC can only be performed using QC materials placed on a diluent rack inserted
into a diluent track in the Sample Area.
Programming a QC Profile
To program a QC profile:
1. Define one or more QC profiles before programming a QC profile. See Defining QC Profiles.
4. In the QC Test Status List, double-click a test to open the QC Statistics screen.
5. <Optional> Select the Material/Test View icon in the toolbar to toggle the navigation tree to
the appropriate view.
6. <Optional> Select the Clear QC Selection icon in the toolbar to remove all selections in the
navigation tree.
7. Click the Select QC Profiles icon in the toolbar.

8. In the Select Multiple QC Profiles dialog box, select one or more QC profiles.
9. Select OK.
See Also
l Restriction Map
l Test Feasibility
l Defining QC Profiles

Reviewing QC Results
The QC Results List provides a statistical summary of QC results for all material/test combinations.
Viewing and Filtering the QC Results

To view the QC Results List:
2. Select a column heading in the QC Results List to sort the results data by that criteria.
3. To filter the QC Results List, select the Filter icon in the toolbar, or select Actions > Con-
figuration > Filter in the menu bar.
4. Select filter options in the QC Result List Filter dialog box. Select All QCs to display all the result
data.
5. Click OK.

Viewing QC Statistics for a Specific Result

To view statistics for a specific QC result:
1. Open the QC Results List.
l Double-click a material name or test code in the results list.
l Select a material name or test code and select the QC Statistics icon.
3. In the QC Statistics screen, select the Filter icon in the toolbar, or select Actions > Con-
figuration > Filter in the menu bar.
4. Select filter options in the QC Statistics – Date Interval dialog box. Select Apply to all the QCs to
display all the statistics.
5. Click OK.
Viewing QC Statistics in Chart and Grid View

To view QC information in Chart or Grid View:
1. Open a QC result in the QC Statistics screen.
l In the toolbar, select the Grid View icon, the Grid Plus Chart View icon
or the Chart View icon. These icons appear dynamically and in sequence in the
toolbar, and toggle on the respective views in the QC Statistics screen.
l In the menu bar, select a view option on the Actions > Configuration submenu.
3. <Chart View> To view both the active and alternate lot points on the same chart, in either the Active
Lot or Alternate Lot tab, select the Display active/alternate lot option.

Using Multi Chart View

To use Multi Chart View:
1. In the QC Statistics screen, select the Material/Test View icon to toggle the Material/Test Def-
initions tree to one of the following views:
l Test > Materials – Graphically displays the different QC materials used for a specific
test.
l Material > Tests – Graphically displays the same QC material used for different tests.
2. Select Actions > Configuration > Multi Chart View in the menu bar.
See Multi Chart View.
Adding or Viewing Comments

To view or add comments:
1. Open a QC result in Grid or Chart View.
2. <Grid View> Place a check mark in the left column next to the QC result.
3. <Chart View> Place the focus on the result (data point).
4. Select the Comments icon in the toolbar, or select Actions > Review > Comment in the menu
bar.
5. Add comments and select OK.
Tracking QC Information
To track QC information:
2. In the Active Lot or Alternate Lot tab, click to place a check mark next to a test.
3. Select Actions > Review > Tracking information in the menu bar.
The window displays the material name, lot number, and expiration date of the materials used for this test.
Viewing Reaction Curves

To view a reaction curve:
2. Select the Reaction Curve icon in the toolbar, or select Actions > Review > Reaction Curve in
the menu bar.

Omitting Points
You can omit selected points from QC statistics. Omitted points appear on the graph as an X.
To omit points:
1. Open QC results in a Chart View.
2. In the chart, click the result (chart point) to omit.
3. Select the Omit Point icon, or select Actions > Results > Omit Point in the menu bar.
4. Select OK to confirm the omission. A Comments dialog box opens.
5. Enter a comment and select Save.
See Recalculating Interval Statistics.
Restoring Points
To restore omitted data points:
1. Open QC results in a Chart View.
2. In the chart, click the result (chart point) to omit.
3. Select Actions > Results > Restore Point in the menu bar.
4. Select OK to confirm the restoration. A Comments dialog box opens.
5. Enter a comment and select Save.
NOTE: Only a result arrived at after the last QC event (such as QC definition change) can be omitted
or restored.
See Recalculating Interval Statistics.
Recalculating Interval Statistics

To recalculate interval statistics:
1. Place a check mark next to the test you want to recalculate interval statistics for.
2. Select Actions > Results > Recalculate in the menu bar.
3. The QC recalculation follows the same rules as a patient result recalculation and omit/restore points.
4. After recalculation, the results are saved and statistics are recalculated. If the recalculation cannot be
performed or there is an event after the QC result execution date and time, the operation fails and an
error message appears.
NOTE: When recalculating results, the system uses the ISI value from the lot that matches the mate-
rial used during the test. If the lot used during test execution is no longer in the system, or the current mate-
rial with ISI value was not used during the execution, the INR result fails. See Reviewing Test Results for
information on recalculation.

Purging Data
Results from a test up to a certain date can be purged. The purge function can be used with 1) all results; 2)
active lot results only; or 3) alternate lot results only. This operation is intended to remove obsolete data
points. It recalculates the cumulative statistics with the remaining points. Data cannot be recovered after it
has been purged.
NOTE: Purge data is not available if the instrument is running tests.

To purge data:
2. Select Actions > QC > QCPurge in the menu bar. The Purge Data dialog box opens with the fol-
lowing choices:
l Purge All
l Purge Active Lot
l Purge Alternate Lot
3. Select a date in the Purge Data dialog box and select OK.
4. The data up to this date is removed from the chart.
Setting Statistics as Target

The target mean and SD can be replaced with the statistics mean and SD values.
To set statistic as target:
1. Open a result in the QC Statistics screen.
2. Select the Set Statistics Target icon in the toolbar, or select Actions > QC > Set Statistic as
Target in the menu bar.
3. Select OK to confirm your choice. The statistics values for the active lot are copied to the active tar-
get values and the statistics values for the alternate lot are copied to the alternate target values.
Activating an Alternate Lot

An alternate lot can be activated at any time.
To activate the alternate lot:
1. Open a result in the QC Statistics screen.
2. Select the Activate Lot icon in the toolbar, or select Actions > QC > Activate lot in the menu
bar.

Uploading results to the LIS

To upload a result to the LIS:
1. Make sure the LIS is enabled.
2. Open a QC result in Grid View.
3. Place a check mark next to the result to be uploaded.
4. Select Actions > Results > Upload in the menu bar.
Filtering Results for Printing Reports

To filter results for printing reports:
bar.
2. Select filter options in the QC Result List Filter.
3. Select OK. Only displayed results are included in reports.

Printing QC Statistics Reports

To print a QC Statistics Report:
1. Open the QC Statistics screen.
2. <Optional> Filter the results data.
3. Select Actions > Print > Print Compact Report or Print Comprehensive Report in the menu bar.

C ompact R eport

C omprehensive R eport
A QC Statistics Report includes the following information:

l Date and time report generated
l Name of hospital or laboratory
l ACL TOP Instrument
l ACL TOP Instrument Serial Number
l Test code
l QC Material
l Data Interval

l Target
o Mean
o SD
l Statistic
o Mean
o SD
o CV
o N
o Omitted
o Total Data
l Levey-Jennings chart
l Tracking Information
o Material Name
o Lot Number
o Expiration Date
o User Name
l Sample Result Information
o Point No.
o Result
o SD Value
o Unit
o Omitted
o Errors
o Comment
o Date/Time (data interval)
o Target Mean (for the control material when test was completed)
o Target SD (for the control material when test was completed)
o Delta
o CV
o QC Status
o Freq. Status
o Lot ID (for this lot)
o Exp. Date (for this lot)
o Manufacturer (of the control material)

Printing QC Results Status List Reports

To print a QC Results Status List Report:
1. Open the QC Results List screen.
2. Select Actions > Print in the menu bar, or select the Print icon in the toolbar.
QC R esults Status List R eport

A QC Results Status List Report includes the following information:
l Test Code
l Material Name
l Result Unit
l Frequency Status
l QC Test Status
l Lot Number (for the active lot)
l Expiration Date (for the active lot)
l Alternate Lot - enabled check
l Target Mean
l Target SD
l Cumulative Mean
l Cumulative SD
l Number of Results (for the active lot)
l For each QC test the following is displayed for each QC data point of the current day and the active
lot:
o Point Index
o Completion Date
o Result Value
o Result Unit
o SD Value
o DR Flags
o QC Status (after this result was added)
o Frequency Status
o Omitted
o Lot Number
o Expiration Date (for this lot)
o Manufacturer (of the control material)

o Target Mean (for the control material when test was completed)
o Target SD (for the control material when test was completed)
o Delta
o CV
o Comment
Printing QC Test Status Reports

To print a QC Test Status Report:
1. Open the QC Tests Status List.
2. Select Actions > Print in the menu bar, or select the Print icon in the toolbar.
A QC Tests Status Report contains the same information displayed on the QC Tests Status screen.
Exporting Reports
To export a report:
1. Select Export.
2. In the window that opens specify the format and select the destination.
See Exporting Data.
QC Statistics Screen
The QC Statistics screen contains information for both the active and alternate material lots located on the
Active Lot and Alternative Lot tabs.
NOTE: Only active lots are used to monitor quality control. The alternate lot tab provides infor-
mation about QC materials before they are used as an active lot.
The QC Statistics screen can display QC data points in a Grid View, Chart View or Grid Plus Chart View.

NOTE: Failed or omitted results are not provided in QC statistics.
Material/Test Definitions Tree

The Material/Test Definitions tree on the left side of the QC Statistics screen is used to perform the following
tasks:
l Select QCs to run.
l Select material/tests to display in Multi Chart view.

Active Lot Tab

The Active Lot tab contains the results for a particular material/test combination over a certain data interval.
The Data Interval is user-configurable by means of the QC Statistics filter and can be set in terms of the fol-
lowing:
l Last days – The period between the current date and the defined number of days before the current
date. Valid range is 1 to 365.
l From/To – The period between the specified dates.
l Last Points – The last defined number of results received for this test and this control. Valid range is
1 to 999,999.
Select QC Profiles
Clear Tree Selection
Program QC – Starts one or all QCs defined for the selected test. You can also select Actions >
QC > Program QC in the menu bar.
Material/Test View – Toggles sorting the Material/Test Definitions tree between Test view and
Material view. Select the relevant tree view before displaying data in Multi Chart View. Also use
this icon to sort QC tests before Performing a quality control test.
Grid View – Toggles the current view to Grid View. Appears dynamically in the toolbar, in
sequence with the icon and the icon. See
Chart View Grid Plus Chart View View-
ing QC Statistics in Chart and Grid View.
Chart View – Toggles current view to Chart View. Appears dynamically in the toolbar, in
sequence with the icon and the icon. See
Grid Plus Chart View Grid View Viewing
QC Statistics in Chart and Grid View.
Grid View Plus Chart View –Toggles the current view to Grid View Plus Chart view. Appears
dynamically in the toolbar, in sequence with the icon and the
Grid View Chart View
icon. See Viewing QC Statistics in Chart and Grid View.
Omit Point
Set Statistic as Target
Activate Alternate lot

Comment
Test Feasibility List – Checks whether all the materials a selected QC test needs are available for
use. You can also select Actions > Review > Test Feasibility List in the menu bar. See Test Fea-
sibility for complete information.
QC Statistics Filter
Print

Chart View
The Grid View icon, the Chart View icon, and the Grid Plus Chart View icon appear
dynamically and in sequence in the toolbar, and toggle on the respective views in the QC Statistics screen.
The chart view includes a Levey-Jennings chart. The chart shows the variability of the result, in terms of
standard deviations from the mean, over the defined data interval.
Double-click the chart to expand to full screen view.

A legend pops up when you hover the cursor over a chart. For example:
The vertical colored lines on the chart indicate that certain events have taken place. Click the vertical line for
a description and date and time of the event.
Red Active Lot Changed – The active lot for the related QC material changed due to:
l Enable or disable lot management
l Active lot definition change.
Yellow Target Values Updated – Target values were updated due to:
l Active lot assigned values change in QC definition
l Active lot assigned values change in related QC material
l Alternate lot assigned values change in QC material.
Green QC Definition Changed – The QC definition changed due to:

l Rules change in QC definition

l Unit change in QC definition
l Frequency configuration change in QC definition
l Patient flags change in QC definition
l Alternate lot definition change for related QC material
l Enable or disable of test definition.
Blue Related Reagent Lot Changed – The QC test related reagent lot changed due to:
l Enable or disable of lot management
l Active lot definition change
l Alternate lot definition change.
NOTE: You cannot omit a QC point from QC statistics after one of the above events has occurred.
Chart View Display Settings

l Scale +/- – To change the Y-axis display scale, enter a value in the Scale +/- field.
l Display Alternate Lot – To view the Alternate Lot QC data, select this field.
l Statistic Mean – If selected, a red horizontal line is added to the chart to indicate the Statistic Mean
value.
l Trend Line – If selected, a green linear regression line is added to the chart to indicate the trending of
the data.

Grid View
The Grid View icon, the Chart View icon, and the Grid Plus Chart View icon appear
dynamically and in sequence in the toolbar, and toggle on the respective views in the QC Statistics screen.
Column Headings
l Select – Click one or more cells in this column to place check marks, selecting rows to perform
actions on. Click the Select icon in the column heading to select or deselect all the rows in the
table.
l No. – QC point number from the defined interval. See Filtering the Results List.
l Completed D&T – Completion date and time for the QC result.
l Result – Numerical value of the QC test result.
l Unit – QC result unit as defined in the QC Setup Definition.
l SD Value – A calculated number that tells how many standard deviations a control result is from its
mean value and is the Z-Score value for Levey-Jennings chart. Calculated as: (Result Value - Target
Mean)/Target SD.
l Check box – A check mark indicates an error or warning is associated with the QC test result.
Click the check mark to view details.

l QC Status – Indicates whether the individual QC result PASSED or FAILED the defined QC rules, or
been OMITTED. When QC has failed, click this field to open a window showing which rules failed.
When the status is OMITTED, that point is not included in the QC statistics.
l Frequency Status – If QC Frequency is enabled, indicates the status of the test – either Overdue, Due
or OK, and represents the status at the time QC was executed.
l Omitted Point – If checked, indicates that a QC result has been removed from the statistical cal-
culations.
l Upload Status – If checked, indicates that the QC test has been uploaded to the Host.
l Lot ID – The lot ID for the control material.
l Exp. Date – The expiration date for the control material lot.
l Manufacturer – Manufacturer of the control material.
l Target Mean – Expected mean value for the control material as defined in the product insert, or as
defined by the user. See Assigned Values.
l Target SD – Expected standard deviation for the control material as defined in the product insert, or
as defined by the user. See Assigned Values.
l Delta – The difference between the target and the measured result
l CV – CV of the QC point as compared to the initial target mean defined for an active lot. See
Assigned Values. If the target mean changes, this CV value represents the CV compared to target
mean before any changes.
l Comment – If checked, indicates that a user has entered a comment for this result.
l Ordered by – User ID of the person logged on when the QC test was performed.

Grid Plus Chart View
The Grid Plus Chart View combines both the Grid and Chart Views, including functionality, into one view.

Multi Chart View

Use Multi Chart View to graphically compare QC results for:
l Different tests using the same QC material; or
l Different QC materials within the same test.
This view shows all the available chart information for 1) the test; and 2) the materials for the test selected in
the tree. The maximum number of graphs displayed per tab is four. The maximum number of tabs is six. Only
graphs that contain values for at least one not-failed test are displayed.
In Multi Chart view, you can drag and drop charts within or between tabs.
See Using Multi Chart View.
See Also
l Quality Controls
l QC List
l QC Overview
l QC Profiles List
l QC Results List


CHAPTER 10 Sample Analysis
CHAPTER 10
SAMPLE ANALYSIS
Sample Collection and Storage

A detailed procedure for collection, transport, and preparation of plasma for coagulation testing is necessary
since important diagnostic and therapeutic decisions are based on the results of these tests. Many variables
are important because they affect the analytical results (for example: type of anticoagulant, storage of the sam-
ple, and the collection container for the blood sample. The following procedures are considered standard for
any coagulation test.
Plasma Collection
Perform the following procedures when collecting plasma:
1. Draw blood with minimum stasis using a plastic syringe.
2. Transfer the drawn blood into a graduated polystyrene (or similar plastic material) test tube to avoid
activation of the contact phase of coagulation. Alternatively, use an evacuated siliconized glass tube
or an evacuated glass in plastic.
3. Immediately after drawing blood, anti-coagulate the plasma with one volume 3.2% trisodium citrate
mixed with nine volumes of freshly drawn venous blood. Mix thoroughly.
The correct concentration of the anticoagulant is fundamentally important to the precision of the results. Ref-
erences to the CLSI (formerly NCCLS) guideline may be followed when adjustments to the citrate con-
centration are required due to sample hematocrit variations.
Plasma Separation
Avoid hemolysis during collection and centrifugation of the sample. The breakage of red cells whose phos-
pholipid surfaces have thromboplastin activity causes a change in coagulation times. Therefore, centrifuge
samples as soon as possible according to the latest CLSI guideline.
See Also

Chapter 10 – Sample Analysis
Sample Area
The left side of the Analytical Module1 is the Sample Area where patient samples are manually loaded onto
the AM. Place sample material on racks and insert the racks through the bar code reader.
The Sample Area screen shows the status of all the racks in the sample area. Use the Sample Area screen to
program tests for each sample.
Accessing the Sample Area

To access the Sample area:
bar.
2. Use the Sample Area screen to program tests for each sample.

Sample Area

Sample Area Operations Toolbar

The Sample Area operations toolbar includes the following:
Run Tests – Starts an analytical session. Disabled if the analyzer is running or is in any status
other than Ready. You can also select Actions > Map > Run Tests in the menu bar. Also
available on the Sample Rack Details screen.
Test Feasibility List – Opens the Test Feasibility and QC Feasibility Lists. See Test Fea-
sibility.
Restriction Map – Opens the Restriction Map.
Rack Details – Opens the Sample Rack Details screen for the rack that has focus1 in the Sam-
ple Area screen.
Print – Prints a report showing the status of all inserted racks that have at least one material
placed on-board, and the status of these materials. Useful when a maintenance activity is per-
formed that requires the removal of material racks.

Sample Area
Sample List Toolbar

The following icons can appear in the Sample List toolbar depending on the instrument model:
Use the following icons to navigate in the Sample List, Reagent Area and Diluent Area.
Returns to the Previous screen.
Displays the QC Results List.
Displays the Calibration Status List.
Display the LAS Cuvette Holding Area for TOP 700 LAS.
Displays the Reagent Area (Reagent/Diluent Area for TOP 300 CTS and 500
CTS ).
Displays the Diluent Area.

Sample Area Screen

The Sample Area is at ambient temperature and holds up to 12 racks, depending on the instrument model.
Each rack can hold 10 samples.
track position. When the rack is no longer in use the LED changes to green and the rack is released. When
a rack is inserted with samples, and one or more sample tests are PLACED, NOT FEASIBLE, or ACTIVE,
that rack displays in the Sample Area screen as light blue. See Racks.
The non-CTS sample rack holds both open sample tubes and sample cups.
The CTS sample rack holds closed sample tubes. See Closed Tube Sampling and Global Definitions.
TOP 300 CTS Sample Area Screen

Sample Area
TOP 500 CTS Sample Area Screen

TOP 700 Sample Area Screen

Sample Area
TOP 700 LAS Sample Area Screen
TOP 700 LAS Cuvette Holding Area

See LAS Cuvette Holding Area.

Restriction Map
The Restriction Map shows which tracks you can insert various types of materials. For example, on the TOP
700 sample diluents can be inserted only into tracks D1 and D2, and start reagents can be inserted only into
tracks R3-R6. See Restriction Map.
CAUTION:
l IMPORTANT – Many IL-defined tests use Clean B diluted as the clean material. If the Clean B
all work that was in progress. To avoid this, place multiple bottles of Clean B diluted on-board the
instrument. See Restriction Map for correct placement.
l When loading sample, diluent or reagent racks, the racks must be pulled all the way out before load-
ing. Pulling out racks partially while loading or changing bottles, tubes, or sample cups may result in
incorrect identification of the rack contents.
l TOP 300 CTS – Clean materials used by the sample probe must be placed in track D1. Those used by
the reagent probe must be placed in track R1 - R3.
l TOP 500 CTS – Clean materials used by the sample probe must be placed in track D1. Those used by
the reagent probe must be placed in track D2 - R4.
l TOP 500 CTS – If you define a sample diluent material and select the Rinse and Clean option requir-
ing a non-system clean material such as Clean B, that clean material must be placed in track D1.
l TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS – If you define
a sample diluent material and select the Rinse and Clean option requiring a non-system clean mate-
rial such as Clean B, that clean material must be placed in track D1 or D2.
l TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS – Clean mate-
rials used by the reagent probes must be placed in tracks D3 - R2, R5 - R6.

Sample Area
Restriction Map – TOP 300 CTS

Restriction Map – TOP 500 CTS

Sample Area
Restriction Map – TOP 700

For ACL TOP 700 (includes ACL TOP Base) and ACL TOP 700 CTS (includes ACL TOP CTS) instruments.
Restriction Map – TOP 700 LAS

Racks
A non-CTS sample rack is represented on the left, a CTS sample rack is in the middle, and Sample rack
present with test PLACED, NOT FEASIBLE or ACTIVE is on the right.
NOTE:
l The CTS sample rack is identified with CTS on-screen.
l Sample #1 is at the top of the rack. Sample #10 is at the bottom.
l A sample rack may hold cups of calibrator1, controls, and patient samples as well as tubes of patient
samples.
l The color-coded circles in the rack representation correspond to the 10 sample positions in the sample
rack.
l When you hover the mouse pointer over a colored sample, its sample ID appears in a tooltip.
l When you single-click a sample, you get information about the sample such as the sample ID, the
tests to be performed on the sample, and time to completion for a test in progress. For example:

Sample Area
l When a rack is inserted with samples, and one or more sample tests are PLACED, NOT FEASIBLE, or
ACTIVE, that rack displays in the Sample Area screen as light blue.
Offline Racks
The rack to the far left in the Sample Area screen represents an offline rack that is on your workbench and
not inside the analyzer. You can pre-program the samples for that rack before inserting it into the analyzer.
You can program the rack after it has been inserted, but it is often preferable to do it beforehand. See Mate-
rial Identification.
On-board Racks
You can access a rack by pressing the buttons in the instrument or touching or clicking the on-screen buttons
on the track control panel. The bar code indicator on the CM and the bar code reader on the AM both move.
As the selected rack is placed on the instrument it is also displayed on the screen.
NOTE:
l An ambulance on the sample rack circle indicates a priority (stat) sample.
l A red cross symbol indicates a stat1 sample.

A question mark indicates an unidentified sample. This happens when the sample does not have a bar code
label and it has been inserted without having been manually programmed. For a full listing of the color
codes, see Sample Status Color Codes.

Track Control Panel

Below the rack area on the screen is the Track Control Panel. Each track is identified by the abbreviations S
<sample>, D <diluent> and R <reagent>.
TOP 300 CTS Track Control Panel
TOP 500 CTS Track Control Panel
TOP 700 Track Control Panel
TOP 700 LAS Track Control Panel
Each track access button can be used to insert and remove a rack from the analyzer. It is functionally iden-
tical to the physical buttons on the analyzer. Pressing the physical buttons or touching or clicking the on-
screen buttons all move the bar code reader to that track position to allow the rack to be inserted.
Each track position button has an LED indicator below it.
l Gray – No rack is on-board.
l Green – Rack is not in use, is accessible.
l Orange – Rack is in use, not accessible.
l Button grayed out (S1-S3) – Rack is not available – for use by LAS only.
Bar Code Reader Indicator

Just above the Track Control Panel is an indicator for the location of the bar code reader:
Bar code reader movements are simulated on the computer screen. When you press a track access button, the
bar code reader indicator appears above the button after the bar code reader reaches this position.

Sample Area
See Also
l Sample List
l Sample Details


The LAS Cuvette Holding Area screen is a graphical representation of samples that have begun aliquotting
from the LAS track and are scheduled for testing, or are in the process of testing. You can delete tests from
samples in the holding area, but you cannot add tests.
Accessing the LAS Cuvette Holding Area

To open the LAS Cuvette Holding Area screen:
l Select Analysis > LAS Cuvette Holding Area in the menu bar.
Or
1. Select the Sample Area icon in the toolbar.
2. Select the LAS Cuvette Holding Area icon in the toolbar.
Deleting a Test
To delete a test from a cuvette in the LAS Cuvette Holding Area:
1. Open the LAS Cuvette Holding Area.
2. Click a Test cell to place focus1 on the test to delete.
3. Select the Delete Test icon in the toolbar.

4. In the Test and Profiles dialog box, deselect one or more tests to delete.
NOTE:
l You cannot add a test to a cuvette in the LAS Cuvette Holding Area.
l If the test has started, you cannot delete it.

LAS Cuvette Holding Area Operations Toolbar

The LAS Cuvette Holding Area operations toolbar includes the following:
Run Tests – Starts an analytical session. Disabled if the analyzer is already running or is in any
status other than Ready. You can also select Actions > Map > Run Tests in the menu bar. Also
available on the Sample Rack Details screen. See Sample Rack Details.
Test Feasibility List – Runs Test Feasibility.
Delete Tests – Deletes the test selected in the cuvette cell. A cuvette cell must have focus1 in the
LAS Cuvette Holding Area screen.
Restriction Map – See Restriction Map.
Sample Details – Displays the Sample Details screen.
Patient Demographics – Displays patient information, such as name, gender, DOB, patient ID, etc.
Bar Code Home Position – Allows you to move the bar code reader to its home position without
having to wait.
Print – Prints a report showing the state of all inserted racks that have at least one material placed
on-board, and the state of these materials. Useful when a maintenance activity is performed that
requires the removal of material racks.

LAS Cuvette Holding Area Screen

C uvette Strip
Graphical representation of a cuvette strip1 containing four cuvette wells. Each cell contains a separate ali-
quot2 taken from a sample on the LAS track.
When displayed, it indicates the presence of a cuvette strip in the LAS Cuvette Holding Area. Click here for
color indicators descriptions.
Hover the cursor over a cuvette well to display a tooltip with the status of the sample.
When the cuvette strip is in focus, the Sample ID and Test cells populate with the values associated with that
sample.
LA S C uvette H olding A rea A vailability Indicator
Represents an available position for sample analysis. A maximum of 7 indicators can display. The number of
available positions is inversely related to the # Slots for dilution preparation value configured in the LAS
Configuration screen. When the # Slots for dilution preparation value is 2, seven indicators are present. Use
this configuration for maximum throughput when testing samples. You can adjust the configuration to opti-
mize sample or calibration throughput. See Adjustments for Calibration.
Sample ID
Obtained through communication with the LAS track. You may not manually enter a value into this field.
1
2A known fraction of a whole, constituting a sample.

Test C ells
To the right of each row are Test cells in two rows and several columns for each sample. More columns are
available as needed – up to 30 tests for each sample. When you select a test cell an ellipsis displays to
the right of the cell.
See Also
l LAS Overview
l LAS Configuration

Sample Rack Details
Sample Rack Details

The Rack Details screen contains information for each sample placed on a rack.
Accessing Sample Rack Details

To access sample rack details:
bar.
2. In the Sample Area screen, do one of the following:
l Double-click a sample rack representation or a sample position on the rack.

l Select Actions > Review > Rack Details in the menu bar.
l Select the Rack Details icon in the toolbar.
Programming Sample Tests

To select one or more tests to run on a sample:
1. Open the Rack Details screen.
2. Select the sample type in the Sample type list. Select Patient for medical tests.
3. Select the sample ID in the Sample ID list. If you selected a Cal/NPP or Quality Control sample
type, this field becomes a drop down list of available materials to use for calibration, NPP1, or quality
control.
4. Select the Stat option if the test is high priority.
5. <Optional> If the sample type is Quality Control or Cal/NPP, and lot management is enabled for the
sample, select to use the active or alternate lot.
6. Click a test cell on the right side of the Rack Details screen.
7. Select the dynamic ellipsis that appears on the right side of the test cell, or select the Add/Re-
move Tests icon in the toolbar to open the Tests and Profiles window.
8. Select a test or profile in the Tests and Profiles window, and select OK.
9. Repeat these steps for each test to run on the sample.
10. IMPORTANT – See Tests and Profiles window for important information about tests.

Deselecting Tests
When you click a named cell in the Tests and Profiles window, that test name is copied to the test list on the
Rack Details screen and the test button on the Tests and Profiles window is depressed. Clicking a button a
second time removes the test name from the Rack Details screen and deletes the test order. You can also dese-
lect a test that has been ordered in the Sample List screen if the test has a TO DO status.
To remove a test with TO DO status from a sample:
1. Select the Sample List icon in the toolbar, or select Analysis > Sample List in the menu bar.
2. In the Sample List, select the sample ID with a test with TO DO status.
3. Select the Sample Details icon in the toolbar to open the Sample Details screen.
4. On the Test Information tab, place focus1 on the TO DO test and press the <Delete> on the keyboard
before the test executes.
Sample Area Toolbar

The Sample Area toolbar includes the following:
Run tests
Display Test Feasibility List
Display the Restriction Map
Display Rack Details
Move Bar Code Reader to home position

Sample Rack Details
Sample Rack Details Operations Toolbar

The Sample Rack Details screen toolbar includes the following:
Run Tests – Starts an analytical session. Disabled if the analyzer is running or not Ready. You
can also select Actions > Map > Run Tests in the menu bar.
Auto List – Automatically programs a set of patient tests (for those in the TO DO state) that exist
on the system. Applies only to patient tests and is only available for the off-line rack in the sam-
ple area (also see Reagent Area). The sample programming information is automatically loaded
and displayed based on the priority of each sample. See Programming Non-Bar Coded Samples
(Using an LIS).
Add/Remove Tests and Profiles
Clear Rack – Clears all the material information. Available only for the off-line rack and disabled
for all other racks.
Insert Rack – Inserts a rack carrying the information and materials you defined on the off-line
rack. Disabled for all other racks.
Test Feasibility List – Opens the Test Feasibility List.
Display Patient Demographics
Open Sample Details to view detailed rack information
NOTE: After selecting the run command,


See Run and Autorun.

Sample Rack Details
Sample Rack Details screen
The picture below shows 2 rows of the test list displayed in the Rack Details screen. All the rows are similar,
with one row for each sample.
Select a row to configure by clicking the sample position at the left side of the screen. The selected sample
has a ring around it to indicate it has focus.
When you hover the cursor over a test, a tooltip displays the result for that test.
Click the following icons on the right side of the toolbar to display the sample Rack Details screen for the
rack to the left or right of the currently displayed rack.
and
Sample Type
The default sample type is Patient. The following sample types appear in the list:

l Patient – A sample being analyzed for medical purposes.

l Cal/NPP – A grouping that allows a single material to be used for multiple sample types.
o Cal (Calibrator) – A sample with an assigned value used to calibrate a test.
o NPP (Normal Pool Plasma) – A sample used as a standard of comparison for calculating: 1)
INR; and 2) test results that use the normalized ratio.
l Quality Control – A sample having known amounts of analyte that is used to monitor system per-
formance.
Sample ID
Unique identifier of the sample. This value is normally obtained by scanning a bar code label on a sample
tube. You can also manually enter a value into this field. It must be an alphanumeric value with fewer than
16 characters. You cannot change the sample ID while the sample is in use. This field can be edited only
when the sample type is Patient.
For Cal/NPP and Quality Control samples, this field becomes a drop down list of available materials to use
for calibration, NPP1, or quality control.
Stat
The Stat option specifies a high-priority patient sample. The priority codes for samples and tests are:
l Normal – Regular priority
l LAS – Higher priority (for all samples from the LAS track)
l Stat – Highest priority (available for front-loaded samples only)
l Partial – One or more, but not all tests for the sample are stat
CAUTION: Continuously adding stat2 samples delays testing on non-stat samples, possibly indef-
initely.
Lot Selection
If the sample type is Quality Control or Cal/NPP and lot management is enabled for the material, a pair of
buttons is displayed to the right of the stat indicator. These buttons allow you to select either the active lot
or the alternate lot.
Test Selection
To the right of each row are Test cells in two rows and several columns for each sample. More columns are
available as needed – up to 30 tests for each sample. When you select a test cell an ellipsis displays to

Sample Rack Details
the right of the cell.
After you click the ellipsis, the Test and Profiles window opens, allowing you to select from the available
tests and profiles. You can also double-click the test list cell or use the Add/Remove Tests icon in
the toolbar to open the Tests and Profiles window.
The Tests and Profiles window is also available from the Sample List screen menu item Actions > Results >
Add/Remove Tests when a sample is selected (has a check mark in the Select column).

Tests and Profiles Window
Use the Tests and Profiles window to program tests to run on samples.
Programming the Tests and Profiles window is similar to programming the Material Programming Window.
NOTE:
l A profile is a set of tests. Up to 15 tests may be in a profile. Profiles are underlined to distinguish
them from individual tests. When a profile is selected, all the buttons for the tests in that profile are
depressed on the Tests and Profiles window.
l You cannot type a test name into the cell. Tests must be selected through the Tests and Profiles win-
dow.
l You cannot select tests for a sample that does not have a sample ID.
l When you click a named cell in the Tests and Profiles window, that test name is copied to the test
list on the Rack Detail screen, and the test button on the Tests and Profiles window is depressed. You
may select more than one test.
l Tests in a profile must be deselected individually. Pressing a profile button a second time does not
deselect the tests in that profile.
l The ACL TOP instrument does not run duplicate tests, whether ordered through the LIS or ordered
manually. Only one test is performed per test code, per sample. To run duplicate tests on a sample,
you must either 1) configure the test definition to run a replicate; or 2) wait until a test has generated
test results.
l If you select the Apply to each Sample ID option at the bottom of the Test and Profiles window
before selecting a test, each test you select is assigned to all sample IDs in the rack.
l If you assign more than 10 tests to the sample, you can use the scroll arrows at the right side of the
test list to view the cells containing the test names.

Sample Rack Details
Rack Summary Information

After you request a test, a summary information table appears below and to the left of the test table with the
following information:
l Track ID value – Identifies the track number where the rack is placed.
l Rack ID – Displays the rack ID that is read on the rack bar code label.
l Number of samples
l Number of tests
See Also
l Sample List

Programming Bar Coded Samples
NOTE:
l To perform these procedures, the Enable Bar Codes option must be pre-configured in the Bar Code
Definitions setup screen.
l Feasible tests programmed for samples placed on-board while the instrument is performing analysis are
immediately scheduled when you perform the operations in this topic. It is not necessary to re-select
the Run icon for these tests when the instrument is already running.
Programming Bar Coded Samples Using an LIS (Host)
1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar.
2. Select an available track position from the track control panel.
3. Insert a rack containing bar coded samples into the ACL TOP instrument. See Restriction Map. The
system reads the bar codes and programs the Sample IDs automatically into the Rack Detail screen.
The programming of the tests is obtained from the LIS, according to the LIS communication con-
figuration (host query or batch downloading).
4. Select the Run icon to start the analysis.

Programming Bar Coded Samples
Programming Bar Coded Samples After Loading the Rack, Without an

LIS
3. Insert a rack containing bar coded samples into the ACL TOP instrument. See Restriction Map. The
system reads the bar codes and programs the Sample IDs automatically into the Rack Detail screen.
4. Select the Rack Details icon to open the Rack Detail screen.
5. Select the Stat option if the sample requires immediate action.
NOTE: Continuously adding stat1 samples delays testing on non-stat samples, possibly indef-
initely.
6. Select the Add/Remove Tests icon to open the Tests and Profiles window. Program the appro-
priate tests by selecting the test and/or profile buttons (profiles are underscored).
See Also
l Laboratory Information Systems
l Bar Code Definition
l Manually Programming Non-Bar Coded Samples

Programming Non-Bar Coded Samples
Programming Non-Bar Coded Samples Using the Offline Rack and an

LIS (Host) with Automatic Downloading Enabled
You can use this method if your laboratory is connected to an LIS after the information regarding the samples
to be programmed has been downloaded from the LIS to the analyzer.
2. Double-click a sample on the offline rack (located on the left side of the screen) to open the Rack
Details screen.
3. Select the Auto List icon. The LIS orders populate the screen.
4. Load the rack in the sample ID order shown on the screen.
5. Select the Insert Rack icon.

6. Insert the rack into the ACL TOP instrument.
NOTE:
l If you manually identify a material placed on the off line rack (sample, diluent, or reagent) and a tube
or bottle containing a bar code is on the rack, the system attempts to match the information manually
entered with the information on the bar code in that position. If the bar coded information fails to
match the manually entered information, the system generates an error message.
l If you manually identify the presence of a material (tube, bottle, or sample cup) placed on the off line
rack (sample, diluent, or reagent) and, upon insertion, the bar code reader does not detect the presence
of that material, an error message displays for that position that the system was expecting to detect the
material's presence.
l If you fail to manually identify the presence of a material (tube, bottle, or sample cup) placed on the
off line rack (sample, diluent, or reagent) and, upon insertion, the bar code reader does detect the pres-
ence of a material, an error message displays for each detected position that the system was not expect-
ing to detect.

Programming Non-Bar Coded Samples After Inserting the Rack, Using

an LIS with Host Query Enabled
3. Insert the rack into the ACL TOP instrument. See Restriction Map. The samples positions are dis-
played with question marks, indicating the system detects their presence but has no sample ID infor-
mation (unknown samples). If Host Query is enabled, the instrument automatically queries the LIS
when a rack is inserted.
4. Select the Rack Details icon to open the Rack Details screen.
5. Enter the sample ID in the Sample ID field.
initely.
7. The LIS is queried for test requests and if it finds any for the sample ID, enters them in the test list
field to the right of the sample ID.

Programming Non-Bar Coded Samples After Inserting the Rack, With-

out Using an LIS
1. Select the Sample Area or select Analysis > Sample Area in the menu bar.
3. Insert the rack into the ACL TOP instrument. See Restriction Map. Notice the samples positions are
displayed with a question mark, indicating that the system identified their presence but had no Sam-
ple ID information (unknown samples).
NOTE: When a rack is inserted, the instrument automatically queries the LIS only when Host
Query is enabled.
4. Select the Rack Details icon to open the Rack Details screen.
initely.
7. Select the Add/Remove Tests icon to open the Tests and Profiles window. Program the appro-
priate tests by pressing Test and/or Profile buttons (profiles are underscored).

Programming Non-Bar Coded Samples Using the Offline Rack, With-

out Using an LIS
2. Double-click a sample on the off line rack (located on the left side of the screen) to open the Rack
Details screen.
initely.
5. Select the Add/Remove Tests icon to open the Tests and Profiles window.
6. Program the appropriate tests by pressing Test and/or Profile buttons (profiles are underscored).
7. Select the Insert Rack icon.

8. Insert rack into the ACL TOP instrument.
NOTE: Feasible tests that are programmed for samples placed on-board while the instrument is per-
forming analysis are immediately scheduled. Pressing the Run icon again is not required when the
instrument is running.
See Also
l Laboratory Information Systems
l Bar Code Definition
l Programming Bar Coded Samples

Reviewing Sample Status

To review the status of an on-board sample:
2. View the test fields at the right side of the Sample List for the results of individual tests performed on
the sample. See Sample Details.
See Also
l Sample Details
l Sample List
l Test Details

Reviewing Test Results

Test result values are shown in a data table at the right side of the Sample List.
Recalculating Test Results

To recalculate test results:
2. Select1 one or more samples in the Sample List.
3. Select Actions > Results > Recalculate in the menu bar.
4. <Optional> Select Stop in the window with a progress bar to interrupt the recalculation if it takes too
long. Results recalculated remain recalculated, and additional recalculations do not process.
This causes the values to recalculate after you have made a change to any of the following:
l Test definition data reduction fields
l Delay or acquisition times
l Calibration
l Parallelism data reduction fields
NOTE:
l When recalculating results, the system uses the ISI value from the lot that matches the material used
during the test. If the lot used during test execution is no longer in the system, or the current material
with ISI value was not used during the execution, the INR result fails. See Reviewing Test Results
for information on recalculation.
l Recalculation is disabled if the test status is Validated or Not Completed.
one object.

l You can recalculate results only for tests having editable fields.
l You can recalculate results for all tests, or for only the tests that are filtered to display in the list. See
Sample List.
Validating a Single Completed Test Result

To validate1 a single completed test result:
2. Place focus2 on the sample ID.
4. In the Sample Details screen, select3 the test to validate.
5. Select the Validate icon in the toolbar.
Validating All Completed Test Results for a Sample

To validate4 all the completed test results for a sample ID:
2. Select5 one or more sample IDs in the Sample List.
3. Select the Validate icon in the toolbar, or select Actions > Results > Validate in the menu bar.
4. When the operation completes a black check mark appears in the Validation Status column. See
Sample List Display Settings to display hidden columns.
1The acceptance of test results by the user.

one object.
one object.

Uploading a Single Completed Test Result to the LIS

You can upload validated1 sample results from the Sample List or from the Test Details screen. The LIS must
be enabled before uploading can occur. See Laboratory Information Systems (LIS).
To upload a single completed test result:
2. In the Sample List, place focus2 on a sample ID with test results to upload.
4. In the Sample Details screen, select3 the test with results to upload.
5. Click the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar.
See Upload Status.
Test U pload
A test upload sends the following information to the host:
l Test ID
l Test Status
l Test Order Date
l Test Results
1Test results accepted by the user.

one object.

Uploading All Completed Test Results for a Sample to the LIS

To upload all the completed test results for a sample:
3. Select the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar.
4. When the operation is complete, a black check mark appears in the Upload Status column. See Sam-
ple List Display Settings to display hidden columns.
See Upload Status.
Sample U pload
A sample upload sends the following information to the host:
l Print Status
l Priority
l Sample Status
l Upload Status
l Validation Status
Deleting Results
To delete results or tests:
2. Select a result or test.
3. Select Actions > Results > Delete in the menu bar.


Printing Sample Results Reports

To print a Sample Results Report:
2. In the Sample List select1 one or more samples IDs.
3. Select the Print icon in the toolbar, or select Actions > Print > Sample Results Report in the
menu bar.
Sample R esults R eport

If the test triggered a rerun test, an * appears in the first result cell in the report. The & sign appears for a
result with a rerun test. See Rerun Rules Setup.
A Sample Results report includes the following information:
l Report Date and Time
l Report Header (user configurable) with
o Hospital
o Laboratory
o System (instrument name; for example ACL TOP 700)
o Serial Number (of the instrument)
l Sample ID
l Sample Type
l First Name (user configurable)
l Last Name (user configurable)
l Rack ID
l Position ID
one object.

l Test Code
l Results (including the unit) or status of test if not successfully completed including:
o UNDEFINED
o COMPLETE
o FAILED
o PENDING
o ACTIVE
o TO DO
l Flag
l Performed Date and Time
l Validated
Printing Sample Results Detailed Reports

To generate and print a Sample Results Detailed Report:
2. In the Sample List, place focus1 a on sample ID.
3. Select the Test Details icon in the toolbar to open the Test Details screen.
4. Select Actions > Sample Results Detailed Report > Print in the menu bar.
See Formatting Reports.
Sample R esults D etailed R eport

This report is available only if the test has completed.
The Sample Results Detailed Report contains the same information as the Sample Results Report with the fol-
lowing additions:
l Result for each replicate
l Replicate errors
l Reaction curve graph
l Tracking information

Printing Patient Reports
NOTE: Patient Result Reports are only available for validated results.
To print a Patient Report:
2. In the Sample List, select1 one or more sample IDs.
3. Select Actions > Print > Patient Report.
Patient R eport
If the test triggers a rerun test, an * appears in the first result cell.
If the test triggered a diluted rerun, an & appears in the first result cell.
A Patient report includes the following information:
l Report Date and Time
l Report Header (user configurable) with the following information:
o Hospital or Laboratory Name
o Serial Number (of the instrument)
o System ID number
l Sample ID
l Sample Type
l First Name
l Last Name
l Rack ID
l Position ID
l Test Code
l Results (including the unit) or the status of the test if not successfully completed, including:
o UNDEFINED
o COMPLETE
o FAILED
o PENDING
o ACTIVE
one object.

o TO DO
l Flag
l Performed Date and Time
l Validated
Exporting Reports
To export a Sample Results report:
2. In the Sample List, select1 one or more sample IDs.
3. Select Actions > Export in the menu bar.
4. Specify the format and select the destination on the Export window.
See Exporting Data.
See Also
l Sample List
l Sample Details
l Test Details
one object.

Sample List
Sample List
The Sample List contains information on samples. Only patient samples appear in the Sample List, including
parallelism, extended and diluted tests. Sample information appears on the left side of the Sample List, and
test information appears on the right.
All tests associated with a sample ID appear in the Sample Details screen which, when open, appears under
the Sample List.
See Sample List Display Settings.
Viewing Sample Details

To view sample details:
2. In the Sample List, place focus1 on a sample ID and select the Sample Details icon in the
toolbar to open the Sample Details screen below the Sample List.
3. Select the Test Information tab in the Sample Details screen to view the tests associated with the
sample in focus in the Sample List.
4. Select the Patient Demographics tab to view Sample and Patient information for the sample in focus
in the Sample List.

Selecting and Placing Focus on Samples

To select and place focus on samples:
2. To select one or more samples, click to place a check mark in the Select column of those sam-
ples.
3. To place focus on a sample ID, perform one of the following actions. You can place focus on only
one sample ID. As you move focus to a different sample in the Sample List, the information in the
Sample Details screen changes.
l Press the Up and Down arrow keys on the keyboard to move the blue focus rectangle
up and down the list of sample IDs.
l Select a row in the Sample List to place focus on the sample ID in that row.
l Touch the sample ID cell on the screen.
l Use the Find tool to locate a sample ID in the Sample List.
4. Perform an action on the selected samples. Actions may be performed on multi-selected samples. For
example, you can validate or upload the multi-selected samples, or filter the selected samples by test
code. Multi-selected sample IDs do not have to be in focus.
Combinations of Select and Focus
NOTE: Do not edit the sample ID after an analytical session has started, unless you remove the rack
first.
N ot Selected / N o Focus
Focus
When a sample has focus you can obtain detailed information about the sample and its tests. Only one sam-
ple at a time may have focus.
Selected
Multi-selection is allowed. You can print, validate or upload the sample information for all selected samples.

Sample List
Selected with Focus
Select and place focus to obtain detailed information about a sample and its tests. You can validate and
upload in this configuration.
U nderlined – H idden D ata
An underlined sample ID indicates there are test results that are not displayed in the Sample List. See Sample
List Display Settings to display hidden columns.
Adding and Removing Tests Associated with a Sample

To add or remove tests associated with a sample:
2. Select1 one or more samples in the Sample List.
3. Select the Add/Remove Tests icon in the toolbar.

4. In the Test and Profiles dialog box, select or deselect the tests to add or remove from the selected sam-
ples. Select the Apply to all samples option to perform this action on all samples. See Test Pro-
gramming Window for configuring this dialog box.
one object.

Validating a Single Completed Test Result

To validate1 a single completed test result:
2. Place focus2 on the sample ID.
4. In the Sample Details screen, select3 the test to validate.
5. Select the Validate icon in the toolbar.
Validating All Completed Test Results for a Sample

To validate4 all the completed test results for a sample ID:
3. Select the Validate icon in the toolbar, or select Actions > Results > Validate in the menu bar.
4. When the operation completes a black check mark appears in the Validation Status column. See
Sample List Display Settings to display hidden columns.

one object.
one object.

Sample List
Uploading a Single Completed Test Result to the LIS

To upload a single completed test result:
4. In the Sample Details screen, select3 the test with results to upload.
5. Click the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar.
See Upload Status.
Test U pload
l Test ID
l Test Status
l Test Order Date
l Test Results

one object.

Uploading All Completed Test Results for a Sample to the LIS

To upload all the completed test results for a sample:
3. Select the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar.
4. When the operation is complete, a black check mark appears in the Upload Status column. See Sam-
ple List Display Settings to display hidden columns.
See Upload Status.
Sample U pload
l Print Status
l Priority
l Sample Status
l Upload Status
l Validation Status
Finding a Sample ID
To find a sample ID:
2. Select the Find icon in the toolbar, or select Actions > Results > Find Sample in the menu bar
to open the Quick Search window.
3. Enter all or the first part of the sample ID and select Previous to search up, or Next to search down in
the Sample List.
You can also filter the Sample List to find a sample ID.


Sample List
Filtering Selected Samples by Test Code

To select sample IDs associated with a test code:
3. <Optional> Click the Select column icon in the column heading to select all sample IDs in the
Sample List.
4. Select Actions > Results > Filter Selection by Test Code in the menu bar to open the Test Code
Selection Filter.
5. Select2 one or more test codes in the Available column and click the right arrow to move them to the
Selected column.
6. <Optional> Select one or more test codes in the Selected column and click the left arrow to move
them to the Available column.
7. Select OK to filter the Sample List selection by the test codes in the Selected column.
8. The sample IDs associated with the filtered test codes now appear selected in the Sample List.
one object.
one object.

Changing the Sample List Display Settings

To change the Sample List to another saved configuration:
l Select the Sample List Display Settings icon in the toolbar to display the
default setting.
l Select the down arrow to the right of the Sample List Display Settings icon,
and select a setting from the in menu.
l Select Setup > Display > Sample List Settings in the menu bar, and select a defined set-
ting in the submenu.
3. See Sample List Display Settings to display hidden columns.

Sample List
Configuring Sample List Display Settings

Use this procedure to create and save up to eight configurations of fixed and scrollable columns in the Sam-
ple List table. Also use this procedure to edit an existing configuration.
To configure a new Sample List display setting:
2. Select Setup > Display > Sample List Settings > View in the menu bar.
3. In the Sample List Display Settings dialog box, select a Setting tab to configure with new display set-
tings.
4. In the Configuration name field, enter a name for the new configuration to appear on this tab and the
submenu.
5. <Optional> Select the Default option to make this configuration the default display.
6. Select the Non Scrollable Columns tab. Use the Left and Right arrows to populate the Selected col-
umns list with the fixed columns to appear on the left side of the Sample List.
7. Select the Scrollable Columns tab. Use the upper Left and Right arrows to populate the Selected col-
umns list with the test names to appear in the large scrollable header column to right of the fixed col-
umns in the Sample List.

8. Use the lower Left and Right arrows on the Scrollable Columns tab to populate the Selected test unit
columns list with the test units to appear in the scrollable columns under the test name heading col-
umn to right of the fixed columns in the Sample List.

Sample List
Actions Menu
C onfiguration
Opens the Sample List Filter submenu.
R esults
Opens a submenu with the following options:
l Recalculate
l Validate
l Upload
l Delete
l Find Sample
l Select All
l Unselect All
l Filter Selection by Test Code
l Download Tests Order
l Add/Remove Tests – Opens the Tests and Profiles window where you can manually add or delete a
test for a sample selected in the Sample List.
See Reviewing Test Results.
Print Preview
l Patient Report
Pre-select one or more sample IDs or test codes to preview before printing.
Print


l Patient Report
Pre-select one or more sample IDs or test codes to print.
Export
l Patient Report
l Sample Results (EXCEL) – Exports the filtered list created with Filter Selection by Test Code.
Pre-select one or more sample IDs or test codes to export.
R aw D ata R eport
Includes measured results and results stored within the test (results that were not recalculated). Pre-select one
or more samples or tests for a sample. Only completed tests can generate a report. The report is a text file
placed into the folder specified in Global Definitions/Default File Path.
Patient D emographics
l Save
l Restore
Print Screen
Prints the open screen.
R eview
l Previous screen
l Sample details
l Test details

Sample List
l Results statistics – All results within a time interval, or results inside the normal range within that
time interval, display for each Test Code/Unit. Results include Mean, Number of results, SD, Min and
Max. See Results Statistics.
l Test Counters Statistics – Displays a table with the number of tests (active and alternate) executed for
a test definition since the last reset of this screen. See Test Counters Statistics.

Sample List Toolbar
Sample List Display Settings – Changes the view settings. See Sample List Display Settings to dis-
play hidden columns.
Validate – Use to validate1 selected test results.
Upload – Upload selected test results to the LIS.
Filter – Filters the Sample List. See Sample List Filter.
Find – Search for a sample ID.
Add/Delete Tests
Sample Details – Opens the Sample Details screen under the Sample List. Displays test infor-
mation for the sample in focus2.
Test Details – Opens the Test Details screen for the sample test in focus3.
NOTE: Only patient samples are displayed in the Sample List.

See Sample Area, Sample Details and Test Details.


Sample List
Sample List Screen

Sample List Screen Displaying the Data Area
Each row in the Sample List corresponds to a sample that has been programmed.
Sample List
To sort the Sample List:
1. Click a column heading.
2. Click the same column heading again to sort in reverse order.
3. Click a 2nd column to resort the list. This column becomes the primary sorting criterion, and the first
column sorted becomes the secondary sorting criterion.

Sample List with Tests and Profiles Window

Sample List
Sample List Columns

See Sample List Display Settings to display hidden columns.
Selection C olumn
Click in this column to place a check mark there. This selects a sample. You can multi-select samples in this
column.
Sample ID
Sample unique identifier. Click a row place focus1 on the sample ID in that row. Only one sample ID can
have focus. When the sample has focus, the tests associated with it appear in the Sample Details screen.
Sample Status
Displays the color-coded status of each sample. See Sample Status Color Codes.
Print Status
Status of print jobs associated with the sample. Autoprint must be enabled to activate this column. A black
check mark indicates all actions are complete for all of the tests in the sample. A gray check mark indi-
cates one or more actions are incomplete.
Priority Status
A check mark indicates the sample is a stat, which processes with the highest priority.
CAUTION: Continuously adding stat2 samples delays testing on non-stat samples, possibly indef-
initely.
Validation Status
Validation status of the sample. A black check mark indicates all actions are complete for all of the tests in
the sample. A gray check mark indicates one or more actions are incomplete.
Sample H ighest Error

Code for the highest priority error associated with the sample. If the cell is empty, no error or warning exists
for the sample. If a code is underlined, additional errors or warnings exist for this sample. See Sample List Dis-
play Settings to display hidden columns. See Data Flags for error descriptions.
D ate & Time

Date and time the sample was entered into the system.

R ack ID
Track where the sample rack containing the sample is placed. An LAS value indicates the sample came from
the LAS track. A sample aliquotted from the LAS track is assigned a rack ID of 999. This value is not dis-
played but is transmitted to the LIS.
Position
Position of the sample on the sample rack. An LAS value indicates the sample came from the LAS track. A
sample aliquotted from the LAS track is assigned a rack position of 99. This value is not displayed but is
transmitted to the LIS.
U pload Status
Upload status of sample results to the LIS. A black check mark indicates all actions are complete for all of
the tests in the sample. A gray check mark indicates one or more actions are incomplete.
l Print Status
l Priority
l Sample Status
l Upload Status
l Validation Status
l Test ID
l Test Status
l Test Order Date
l Test Results
On B oard Status
A black check mark indicates the sample is on board.
A dditional C olumn H eadings

See Sample List Display Settings to display the following additional columns:
l First Name of patient
l Last Name of patient
l Patient ID
l Birth date
l Gender
l Status of sample
l Ordered date & time – Date/time of the first test order

Sample List
l Last test completed date & time – Blank if no test has been completed for the sample.
l First test completed date & time – Blank if no test has been completed for the sample.
l Sender ID

Test Information Columns
<test> Columns
On the right side of the Sample List are the Test Results columns. There is one large test results column (with
sub-columns) for each test performed on a sample. The large <test> column contains the test name in the col-
umn heading. Under the <test> are sub-columns that contain the units used for the results and two columns
with icon headings to identify the job type and rerun mode.
The cells in the Test Results column can contain the following information for the sample:
l If the test is complete, the Test Result numeric value is displayed. (FAILED is displayed if the result
failed.)
l If the test is not complete the status appears in the first result column for each test. Status can be: TO
DO, PLACED, NOT FEASIBLE and ACTIVE.
Job Type
Displays a letter to indicate the type or mode of the test performed. The letter for each test type is defined in
Global Definitions in Test Mode Extensions. The most commonly used letters are: E – Extended mode, P –
Parallelism mode, and D – Dilution mode, although you can use any letter you choose for each of these
modes.
R erun Mode
This column displays the following:
o – Rerun test triggered by a previous test.

o – This test triggered a rerun.

Sample List
R esult U nit C olumns

l If the test completed successfully, the mean result for each unit displays.
l If the test completed but the results failed, the word FAILED displays.
l If the test is incomplete, its status displays in the first result column.
l If the result is underlined – There are more results for this test that cannot display. See Sample List
Display Settings to change the display.
l If the result is italicized – There is at least one warning against it. The only exception to this is the
Second Algorithm used flag.
l If the result is purple and bold – The result is out of test range.
l If the result is red and bold– The result is out of linear range but within test range.
l If the result is orange and bold – The result is out of therapeutic range.
l If the result is blue and not bold – The result is out of normal range but within linear range.
l If the result is black and not bold – The result is within normal range.
l An exclamation point displays on the sample status circle to indicate failed results. It appears
based on the last result for each test run, or for a given sample.
Example
If a PT result fails, an exclamation point appears:
l If the test repeats and the result is good (for example: PT=80 seconds) the exclamation point dis-
appears.
l If the test repeats in the extended mode and the result of the PT-E test is good (for example: PT-
E=105 seconds) the exclamation point still appears for the PT result, but not for the PT-E result
because these are two different tests.
In parallelism, if any of the parallelism indices fail (for example, slope, CV) the exclamation point appears.

Time to Completion
At the bottom of the screen, below the instrument status field, the time required to complete running tests dis-
plays dynamically, along with the number of tests completed and ordered.
See Also
l Exporting Data
l Sample Details
l Test Details
l Sample Area
l Test Counters Statistics

Sample Details
Sample Details
Viewing Sample Details

To view sample details:
3. Select the Test Information tab in the Sample Details screen to view the tests associated with the
sample in focus in the Sample List.
4. Select the Patient Demographics tab to view Sample and Patient information for the sample in focus
in the Sample List.
Viewing Parallelism Details

To open the Parallelism Detail screen:
2. In the Sample List, place focus2 on a sample ID with a parallelism test.
3. Select the Sample Details icon in the toolbar.

4. Select the parallelism test in the Sample Details screen.
5. Select the Test Details icon, or select Actions > Review > Test Details in the menu bar to
open the Test Details screen.

Test Information Tab
Column Headings
Job Type
Displays a letter to indicate the type or mode of the test performed. The letter for each test type is defined in
Global Definitions in Test Mode Extensions. The most commonly used letters are: E – Extended mode, P –
Parallelism mode, and D – Dilution mode, although you can use any letter you choose for each of these
modes.
R erun Mode
This column displays the following:
o – Rerun test triggered by a previous test.

o – This test triggered a rerun.
R esult U nit C olumns

l If the test completed successfully, the mean result for each unit displays.
l If the test completed but the results failed, the word FAILED displays.
l If the test is incomplete, its status displays in the first result column.
l If the result is underlined – There are more results for this test that cannot display. See Sample List
Display Settings to change the display.
l If the result is italicized – There is at least one warning against it. The only exception to this is the
Second Algorithm used flag.
l If the result is purple and bold – The result is out of test range.
l If the result is red and bold– The result is out of linear range but within test range.
l If the result is orange and bold – The result is out of therapeutic range.
l If the result is blue and not bold – The result is out of normal range but within linear range.
l If the result is black and not bold – The result is within normal range.
l An exclamation point displays on the sample status circle to indicate failed results. It appears
based on the last result for each test run, or for a given sample.
Example
If a PT result fails, an exclamation point appears:
l If the test repeats and the result is good (for example: PT=80 seconds) the exclamation point dis-
appears.

Sample Details
l If the test repeats in the extended mode and the result of the PT-E test is good (for example: PT-
E=105 seconds) the exclamation point still appears for the PT result, but not for the PT-E result
because these are two different tests.
In parallelism, if any of the parallelism indices fail (for example, slope, CV) the exclamation point appears.

Patient Demographics Tab

Displays information such as Patient ID, Name and Date of birth for the patient from whom the sample was
obtained.
See Also
l Test Details
l Sample Area
l Sample List

Test Details
Test Details
Viewing Test Details

To view test details:
3. In the Sample Details screen select the Test Information tab.
4. In the Test Information tab place focus on a test and select the Test Details icon in the toolbar
to view the Test details screen.
5. Select the Previous Test and Next Test icons in the toolbar to scroll through the test
results for the sample ID in focus in the Sample List.

Printing and Exporting a Parallelism Report

To print or export a Parallelism Report for a completed test:
2. In the Sample List, select one or more patient sample IDs with parallelism results.
3. To print a Parallelism Report, select Actions > Print > Print Parallelism Report in the menu bar.
4. To export a Parallelism Report, select Actions > Export > Export Parallelism Report in the menu
bar.
Parallelism Result report

A Parallelism Result report includes the following information:
l Test code
l Sample ID
l Sample type
l Rack ID
l Sample rack position ID
l Execution date & time
l Validation status
l Validation date & time
l Primary unit at 100%
l Parallelism curve slope
l Calibration curve slope
l Parallelism Y-intercept
l %CV-CR
l Parallelism r2
l Average of correction result
l Parallelism curve
l Parallelism errors
l Concentration

Test Details
l Mean primary value

l Corrected result
l Result
l Replicates
l For each concentration the following is printed:
o Concentration
o Mean (mean value + measured unit)
o Primary (primary value + primary unit)
o Corrected result
o Replicate value (printed once for each replicate up to a maximum of 3)
o Replicate errors and warnings
l Test tracking information
Printing the Clot Curve

To print the clot curve:
1. Display the test details.
2. Select the Print icon in the toolbar.

Test Details Screen
Use the Test Details screen to access detailed information on each test for a sample ID.
Test Information
l Test code– Test code as defined in Test Definition.
l Test type – Type of test. For example: Patient, Calibrator, QC, NPP1, Patient parallel, Extended, etc.
Defined in Test Definition.
l Sample ID– Unique sample identifier as defined on the sample bar code or as manually entered in the
Sample Rack Details.
l Rack ID – Rack identifier of the rack used to run the sample.
l Status – Status of the result.
l Upload status – Status of the result. Uploaded indicates the results were uploaded to the LIS.
l Validation status – The sample validation status.
l Sample position – Position on the rack where the sample was loaded when run.
l Ordered date/time – Date and time the test was ordered (manually or through the LIS). This does not
represent the time the test executed.
l Completed date/time – Date and time the test completed execution.

Test Details
Check Boxes
The check boxes on the left side of the Test Information section indicate the status of the sample ID when
tests were performed.
l CTS – Closed tube sample
l Reflex – A test that orders one or more secondary tests based on preset criteria applied to the initial
test results.
l Rerun – A test that runs again based on preset criteria applied to the initial test results.
Errors and warnings

Table listing the Group, Code and Description of the errors and warnings generated when the sample was
tested. See Data Flags.
Measured
Measured results for replicates. If applicable, additional reported results are also listed in the Unit 1-4 fields.
Reaction graphs
Graphical representation of the reaction curve. Select the Display derivative curves option to display the
derivative curves. The default for this option is configured in Global Definitions.

Displays the Material name, Lot number, and Expiration date of the materials used in the test.

Parallelism Test Details Screen

The following screen displays parallelism results:
Tabs exist for General Information, Tracking Information and one for each dilution (for example, Dilution
100.00%, Dilution 50.00%, etc.)
Enable Display Transformed Axes

On the General Information tab you can select how to display the curve – with or without the transformed
axes – whether X and/or Y axis transformation is enabled in Parallelism Setup. In the screen above, the curve
is displayed with transformed axes.
See Also
l Configuring Factor Parallelism
l Parallelism Setup
l Sample Details
l Exporting Data
l Global Definitions
l Data Flags
l Test Definition

Clot Curve Analysis
Clot Curve Analysis

The PT and APTT tests are used as examples in this topic.
Overview
The ACL TOP instrument provides high quality results from both an accuracy and precision perspective. The
instrument incorporates optical-based reading systems with the means to precisely monitor clotting, chro-
mogenic, and immuno-turbidimetric reactions in the cuvette during the data acquisition cycle. The optical
data is processed by means of sophisticated algorithms as well as data checks designed to ensure that mini-
mum acceptance criteria are met, and also ensuring that results are not reported from significantly abnormal
reaction curves.
In the case of clotting reactions, significantly abnormal conditions may be found, for example, in samples
from patients with liver function impairments. These pathologic conditions are known to cause coagulation
factor deficiencies as well as low fibrinogen levels.Samples from patients with these conditions can be dif-
ficult to analyze. They may result in non-optimal readings especially from mechanical based clotting
analyzers which do not allow the clot to form undisturbed. Samples of this nature should be flagged on all
systems and the reaction visually evaluated. This evaluation can be performed on the ACL TOP systems to
establish a clot time.
Configuring, Viewing and Analyzing Derivative Curves – PT and APTT

examples
The PT and APTT tests are used as examples in this procedure and analyses.
To configure, view and analyze derivative curves:
2. In the Global Definitions screen, under Test definition features, select the Display derivative curves
option to enable the display of clot curves on the Test Details screen.
6. In the Test Information tab place focus on a PT or APTT test (the examples in this pro-
cedure/analysis) and select the Test Details icon in the toolbar to view the Test details screen.
7. On a Replicate tab, select Display derivative curves to view the clot curves for the test in focus.
8. Review the following sections for viewing PT and APTT clot curve examples.
The First Derivative is plotted as a pink line. The Second Derivative is plotted in light blue. The dark blue

line is the standard sample reaction plotted.

For the PT reaction, the clot time is noted at the peak of the First Derivative. For the APTT, the clot time is
noted at the peak of the Second Derivative. These selections correspond to the settings found in the test def-
inition for these test examples.
To view the settings for the test:
2. Double-click the test in the Test List.
3. In the Test Details navigation tree, expand DR Parameters, Primary wavelength and select Primary
algorithm.
When a sample does not meet the criteria defined within the test definition, no result value are displayed. For
these samples the clot curve, with the derivatives curves enabled, can be a useful tool to establish a clot time
for the sample visually.
The display of a clotting reaction is a dynamic display. You can utilize the mouse cursor to view the time
by placing the cursor anywhere along the entire acquisition interval for the standard curve, First Derivative
(pink line), or Second Derivative (light blue line). Positioning the cursor at the peak of the respective curve
(i.e. Second Derivative for APTT) would provide the clot time for that sample, had it met all of the data
check criteria.
The APTT sample below is an example of how to read the curve value.
Example 1 – Low Fibrinogen APTT Sample
This reaction resulted in a Failed result with the error 5071 (Coag) First derivative peak not found.
Double click the reaction graph on the ACL TOP interface to enlarge it.

Clot Curve Analysis
This is a reaction for an APTT processed using HemosILSynthASil. This assay uses the Second Derivative to
establish a clotting time. This reaction shows a standard-looking clot curve with the characteristic S shape.
The S shape indicates the reaction has a baseline, acceleration, and plateau phase. You can also notice a dis-
tinct peak for the Second Derivative (light blue) plot. The Y axis for the graph however has a limited scale.
The readings range from 89 to 106 (curve delta of 17) which is much smaller than what you would normally
obtain processing a sample with a normal fibrinogen value.
For a sample such as this, if you place the cursor at the peak of the Second Derivative you get a reading of
107.7 seconds. This would correspond to the reading obtained if all data check criteria had passed.
The clot curve can be a useful tool to establish what a clot time would be for a sample if the quality data
checks were not enabled in the test definition.
NOTE: Things to keep in mind when using this tool:

l The standard clot curve (dark blue line) should have the characteristic S shape
l A distinct peak for the First Derivative (pink line) should be present for assays using this algorithm.
l A distinct peak for both the First Derivative (pink line) and Second Derivative (light blue line) should
be present for assays using the Second Derivative algorithm.

Example 2 – Extended APTT Sample – Failed Result
This reaction resulted in a Failed result with the error 5071 (Coag) First derivative peak not found.
Double click the reaction graph on the ACL TOP interface to enlarge it.
For this example, the standard clot curve (dark blue line) does not present the classic S shape. The curve has
a baseline and acceleration phase but lacks the plateau phase. In addition there is no distinct peak for the Sec-
ond Derivative (light blue line). This particular clot curve cannot be used to manually establish a clotting
time.
This example presents a sample with an extremely long clotting time. This type of sample would need to be
analyzed on a test/system that does not limit the data acquisition phase in order to establish the APTT clot
time.

Clot Curve Analysis
Clot Curve Analysis

On ACL TOP instrument, the monitored clotting reaction is plotted as a clot curve. A clot curve is generated
for all processed samples. Samples with low fibrinogen often produce a normal looking clotting reaction.
However, if the reaction does not meet the minimum delta specification, the system does not provide a result.
On the ACL TOP systems the clot curve display may be reviewed the following ways:
l Clot Curve reaction solely (no curves)
l Clot Curve reaction plus derivative curves.
An example of each of these is shown below for a PT and APTT reaction:
PT Curve without Derivative Curves

PT Curve with Derivative Curves
APTT Curve without Derivative Curves

Clot Curve Analysis
APTT Curve with Derivative Curves
The PT and APTT appear different due to the algorithm used to identify the clot point of the sample:
l The PT using HemosIL™ RecombiPlasTin 2G reagent is resulted using the First Derivative algorithm;
therefore a single derivative curve is overlaid on the clot curve.
l The APTT using HemosIL SynthASil or APTT SP is resulted using a Second Derivative algorithm;
therefore two Derivative curves are overlaid on the APTT clot curve.
Conclusion
You can use the clot curve evaluate results from compromised samples. In many situations, samples that
present a Failed value (for example, due to very low fibrinogen content [fragile clot]) can be assessed via the
clot curve and a visual result obtained. It is always important to first ensure a clot has formed by reviewing
the clot curve for a baseline, acceleration and plateau phase before reading the result off the appropriate deriv-
ative curve for the particular assay.
See Also
l Primary Algorithm

Results Statistics
The Results Statistics window displays test result information grouped by test code and unit.
Viewing Results Statistics

To view results statistics:
2. With the Sample List open, select Actions >Review > Result Statistics in the menu bar.
3. In the Results Statistics Filter window, configure the date constraints and the results to display.
4. Select OK to display the test results in the Results Statistics window.
5. To print a Results Statistics report, select the Print button on the Results Statistics window. All the
information displayed in the window appears in the report.
6. Select the Preview or Export button on the Results Statistics window to preview or export a Results
Statistics report. See Exporting Data.

Results Statistics
Results Statistics Filter
Filters the results to display in the Results Statistics window.
Enable filter by date/time interval

Option to filter by a date range. Enables the From and To fields.
From and To
Select the date range parameters for results to view in these fields.
Results
R esults Inside N ormal R ange

Displays all non-failed results without the DR flags Normal Range Low or Normal Range High.
A ll R esults
Displays all non-failed results.

R esults from Selected Jobs

Displays non-failed results from jobs you have selected in the Sample List. See: Data Flags.)
Results Statistics Window
The title bar displays the filtering options you chose.

The following columns are displayed:
l Test & Unit – Displays the name of the test and the result unit.
Each of the following are calculated using results that match the test code/test result unit:
l Mean
l Number of Results
l SD
l Min
l Max
l %CV
See Also
l Sample List Area

Test Counters Statistics

There are two Test Counters Statistics windows:
l Simple Test Counters Statistics – Displays only the test code and the total number of determinations
for each test.
l Detailed Test Counters Statistics – Displays more details for each test.
By default, these are only available to Test Specialist/Service level (non-customer) users. However, service
can change the access level for either to a customer level.
Accessing the Test Counters Statistics Windows

To open a Test Counters Statistics window:
2. In the Sample List, select Actions > Review > Simple Test Counters Statistics or Detailed Test
Counters Statistics in the menu bar.
3. The title bar displays the date of the last reset of the counters.
4. To sort the data in the table, select a column. See Sorting Lists.
5. To reset the counters, select the Reset Counters button in the window and confirm when prompted.
All counters reset to 0 and the current date displays in the title bar.
6. To print a Test Counters List or Detailed Test Counters List report, select the Print button in the win-
dow. All the information displayed in the window prints in the report.
7. To preview a report, select the Preview button in the window.
8. Select OK to exit the window.
Simple Test Counter Statistics
Displays the Test Code and the total number of Determinations for all test types.

Detailed Test Counter Statistics
Displays a table containing the number of tests executed for a test definition since the last reset of this
screen.
The number of Standard, Rerun and Reflex tests run for both number of tests and number of determinations is
displayed.
Columns Descriptions
Icon Test Code
Normal Jobs Counter
Extended Jobs Counter
Parallel Jobs Counter
Alternative Predilution Jobs Counter

Icon Test Code
Calibration Jobs Counter – Number of calibrations (not tests) included in the calibration. The
total values are displayed in bold text. Calibration points are counted as individual determinations.
NPP Jobs Counter – Value is displayed in bold.
QC Jobs Counter – Value is displayed in bold.
# Total – Total number of jobs field is calculated by adding patient calibration, NPP, and QC tests.
The value is displayed in bold. Field totals displayed in bold are used to calculate the total number
of tests. Those fields that are not bolded are details of the total number.
For calibration, NPP1 and QC tests, rerun and reflex do not apply. Those cells are blank.
For parallelism, rerun does not apply. Those cells are blank.
If a test is canceled before its completion, the counters are not updated.
See Also
l Test Details
l Sample List

Sample List Filter

By default, all known samples are displayed in the Sample List. Use the up to three filter options to reduce
the selection in the Sample List.
Filtering the Sample List

To filter the Sample List:
bar.
3. In the Sample List Filter dialog box, select a maximum of three filters on the Sample Filters and Test
Filters tabs.
4. Configure the filter criteria for the filters enabled in the previous step. See the descriptions of Sample
List Filters and Test Filters tabs in this topic.
5. Select OK. The filtered results appear in the Sample List.
6. See Sample List to view sample and test details.

Sample List Filter
Sample Filters 1 Tab
Enable filter by sample ID

Option to filter the Sample List by a range of sample IDs. To use this filter, select this option and configure
the sample ID range in the From and To fields. When the same sample ID is entered in both fields, one sam-
ple ID displays.
Enable filter by sample priority

Option to filter the Sample List by sample priority. To use this filter, select this option and choose one of the
following in the Sample priority drop-down list:
l Normal – Displays normal priority samples.
l LAS – Displays samples on the LAS1 track.
l Stat – Displays the highest priority samples.
Enable filter by sample upload status

Option to filter the Sample List by sample upload status. To use this filter, select this option and choose one
of the following in the Upload status drop-down list:
l Not uploaded – Displays sample IDs with test results that have not been uploaded to the LIS.
l Uploaded – Displays sample IDs that have had all test results uploaded to the LIS.
l Partial – Displays sample IDs that have uploaded some, but not all, test results to the LIS.
Enable filter by ordered date/time

Option to filter the Sample List by tests ordered within a date range or by the current date. To use this filter,
select this option, then do one of the following:
1Laboratory Automation System

l Select the Filter by current date option.

l Configure the date range in the From and To fields.
Enable filter by sample validation status

Option to filter the Sample List by sample validation status. To use this filter, select this option and choose
one of the following in the Validation status drop-down list:
l Not validated – Displays sample IDs with results that have not been validated.
l Validated – Displays sample IDs that have had all results validated.
l Partial – Displays sample IDs that have had some, but not all results validated.
l Not validated or partial – Displays 1) sample IDs with results that have not been validated; and 2)
sample IDs that have had some, but not all results validated.
Enable filter by sample print status

Option to filter the Sample List by sample print status. To use this filter, select this option and choose one of
the following in the Print status drop-down list:
l Not printed – Displays sample IDs that have test results that have not printed.
l Printed – Displays sample IDs that have test results that have all printed.
l Partial – Displays sample IDs that have printed some, but not all test results.

Sample List Filter
Set of Filters 2 Tab
Enable filter by patient ID

Option to filter the Sample List by a range of patient IDs. To use this filter, select this option and configure
the patient ID range in the From and To fields. When the same patient ID is entered in both fields, one
patient ID displays.
Enable filter by sample highest error

Option to filter the Sample List by sample highest error. To use this filter, select this option and choose a
sample error code in the Sample error drop-down list. Only samples having the selected error are displayed
in the Sample List. Selecting Any group displays sample IDs the highest error among all the errors or warn-
ings.
Underlined samples in the Sample List have multiple errors. See Alarms and Troubleshooting/Data Flags for a
list of the error codes.
Enable filter by failed jobs

Option to filter the Sample List by failed jobs. To use this filter, select this option and choose one of the fol-
lowing in the Failed Jobs drop-down list:
l Samples with failed jobs – Displays only samples with failed jobs .
l Samples with no failed jobs – Displays only samples with no failed jobs .
Enable filter by patient last name

Option to filter the Sample List by a range of patient last names. To use this filter, select this option and con-
figure the alphabetical range in the From and To fields (For example, enter A-Z or spell out full or partial
last names).
Enable filter by sample status

Option to filter the Sample List by sample status. To use this filter, select this option and choose one of the
following in the Sample status drop-down list:

l TO DO – Displays samples with TO DO status.

l PLACED – Displays samples with PLACED status.
l IN USE – Displays samples with IN USE status.
l COMPLETED – Displays samples with COMPLETED status.
l PENDING – Displays samples with PENDING status.
l NOT FEASIBLE – Displays samples with NOT FEASIBLE status.
Enable filter by sample on board

Option to filter the Sample List by sample on board. To use this filter, select this option and choose one of
the following in the Sample status drop-down list:
l Not on board – Displays samples that are on board.
l On board – Displays only samples that are not on board.

Sample List Filter
Set of Filters 3 Tab
Enable filter by first test completed date/time

Option to filter the Sample List by first test completed within a date range or by the current date. To use
this filter, select this option, then select the Filter by current date option, or configure the date range in the
From and To fields.
Enable filter by last test completed date/time

Option to filter the Sample List by last test completed within a date range or by the current date. To use this
filter, select this option, then select the Filter by current date option, or configure the date range in the
From and To fields.

Test Filters 1 Tab
Enable filter by test code

Option to filter the Sample List by test code. To use this filter, select this option and select a Test code in the
Test code drop-down list.
Test code
List of enabled tests, including parallel and extended tests. Type one or two letters of the test code, then
expand the list to jump to that text string in the list. You can select a test code in the list, or enter the first
letters of the test code in this field. The filter displays all the sample IDs with tests that exactly or partially
match the text string in this field.
R erun
Option to filter the Sample List by rerun. To filter by rerun only, select the Rerun option and leave the Test
code field empty. This configuration displays all sample IDs with a test that triggered a rerun.
Filter by both Test C ode and R erun

To filter by both Test Code and Rerun, enter the test code and select the Rerun option. This configuration
displays sample IDs that ran the selected test and triggered a rerun.
Enable filter by job type

Option to filter the Sample List by job type. To use this filter, select this option and choose one of the fol-
lowing in the Sample status drop-down list:
l Patient – Displays patient jobs in the Sample List.
l Alt. Predilution – Displays alternative predilution jobs in the Sample List.
l Parallelism – Displays parallelism jobs in the Sample List.
l Extended – Displays extended jobs in the Sample List.

Sample List Filter
Enable filter by job error

Option to filter the Sample List by job error. To use this filter, select this option and choose an error code in
the Job error drop-down list. Samples having the selected error display. Selecting Any group displays jobs
with any error or warning.
Underlined samples in the Sample List have multiple errors. See Data Flags for a list of the error codes.
All Samples
The All Samples option applies to all tabs. It cancels all filter criteria and displays all sample IDs in the Sam-
ple List.
See Also
l Sample List
l Sample Details
l Sample Area
l Data Flags
l Alarm Messages


CHAPTER 11 Analyzer Status
CHAPTER 11
ANALYZER STATUS
Analyzer Status Indicators

Next to the General Log icon on the Status Bar is a color-coded indicator of the current status of the
analyzer.
The LED indicates the status of the instrument as follows:
Power-up Blue
Startup initialization Blinking blue
Shutdown initialization Blinking blue
Adjusting thermal Blinking blue
Ready Green
Busy Blue
Controlled stop Blue
Error Amber
Emergency Stop Amber
Maintenance Blinking amber
Diagnostics Blinking amber
Connecting No LED
Not connected No LED
It typically takes up to 30 minutes for the analyzer to complete the power-up process from a cold start. It can
take up to 60 minutes at extreme temperatures.
See Also

Chapter 11 – Analyzer Status

CHAPTER 12 Alarms and Troubleshooting
CHAPTER 12
ALARMS AND TROUBLESHOOTING
Alarm Messages
You are notified of alarm messages through the alarm buttons on the instrument status bar. Alarm warning1
and error2 popup messages communicate important information as needed, such as when operator intervention
is required.
NOTE: Data flags do not appear in popup windows entries in the General Log.
Accessing Alarm Messages

To view an alarm message do one of the following:
l Select the specific alarm button at the bottom of the screen to open that alarm window.
l Select System > General Log in the menu bar to view a list of all archived alarm messages.
l Select the General Log button on the left side of the status bar.
See Alarm Buttons for a complete description of all alarm buttons.
1A warning message indicates that some user action may be required. Warnings do not affect the operation of
the instrument. However, an error condition may eventually occur if the operator does not perform the
required action.
2An error message indicates that a condition has been detected that requires immediate action. Failure to act
may result in the instrument performing an emergency stop.

Chapter 12 – Alarms and Troubleshooting
New alarm messages are displayed in bold text. When you close this window, the message text returns to nor-
mal font. The window can contain up to 200 messages. All messages that occur can be found in the General
Log.
The following alarm message types are listed in this topic, sorted by code number:
l Material Alarms
l Job Frequency Alarms
l QC Alarms
l Maintenance Alarms
l Analyzer Alarms
l External Communications Alarms
l Setup Alarms
l Other Alarms
l Popup and Message Windows
Material Alarms
ing a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate
coordinates adjustment and other errors.
Material Alarms – Warnings and Errors

Code Message Alarm Description Operator Action
1210 Cuvette waste level Cuvette Waste Level The system performed a controlled stop: the run
sensor failure. Sensor Not Respond- has to be re-started. If the problem persists, call
ing. Service.
1215 Unable to empty Waste Accumulator Call Service.

internal waste res- Full Sensor remains in
ervoir. ON state despite
cycling of Waste Pump.
1220 Reagent stirring fail- A check on the power Call Service.

ure. required for stirring
returned an error
1239 Cuvette Loader fail- Failure during cuvette The system performed a controlled stop: the run
ure. indexing detected. has to be re-started. If the problem persists, call
Service.
1240 Cleaning solution Validate LLD height in Perform a Clean prime cycle (Maintenance). If the
low in clean well. Clean well. If too low, problem persists call Service.

Alarm Messages

short sipping may

occur.
1241 <Probe> Clean prim- Clean priming failure. Inspect tubing for kinks and/or leaks.
ing failure.
Check clean solution bottle.
If the problem persists, call Service.
1282 Probe <Probe> Rinse Rinse flow verification Inspect probe tip for blockage and clear if
Flow Test Failure procedure failure blocked.
Inspect tubing for kinks and/or leaks.
Check rinse solution bottle.
Call Service.
1285 Probe <Probe> Liq- LLD error occurred dur- Check probe conditions. If the problem persists,
uid Level Detection ing pipetting operation. call Service.
error in rack position
<X>, track <YY>.
1286 Probe <Probe> miss- Missing post dispense Check probe conditions. If the problem persists,
ing post dispense rinse/clean detected call Service.
error/clean detected.
1292 Probe <Probe> Liq- LLD error in LAS Check probe conditions. If the problem persists,
uid Level Detection Track call Service.
error in LAS Track.
1293 Probe <Probe> Liq- LLD error in cuvette Check probe conditions. If the problem persists,
uid Level Detection call Service.
error in cuvette posi-
tion <X>, slot
<YY>.
1294 Probe <Probe> Liq- LLD error in well Check probe conditions. If the problem persists,
uid Level Detection call Service.
error in well position
<well pos>.
1336 Probe <Arm> Liquid LLD error in LAS Arm Check probe conditions. If the problem persists,
Level Detection error cover aspiration point. call Service.
in LAS Arm cover
aspiration point.


1419 Probe <Probe> The probe detects liq- Check probe conditions. If the problem persists,
unexpected liquid uid but the measured call Service.
level in rack position position of the liquid is
<X>, track <YY>. unexpected.
level in cuvette posi- position of the liquid is
tion <X>, slot unexpected.
<YY>.
level in well position position of the liquid is
<well pos>. unexpected.
1422 Probe <Probe> Pre Invalid liquid detec- Check probe conditions. If the problem persists,
Aspiration Baseline tion: difference in base- call Service.
Check Failure in rack line values read before
position <X>, track and after liquid detec-
<YY>. tion is too low.
Check Failure in line values read before
cuvette position and after liquid detec-
<X>, slot <YY>. tion is too low.
well position <well and after liquid detec-
pos>. tion is too low.
1425 Probe <Probe> aspi- Invalid liquid detec- Check probe conditions. If the problem persists,
ration baseline check tion: difference in base- call Service.
failure in rack posi- line values read before
tion <X>, track and after aspiration is
<YY>. too high.
failure in cuvette line values read before
position <X>, slot and after aspiration is
<YY>. too high.

Alarm Messages


failure in well posi- line values read before
tion <well pos>. and after aspiration is
too high.
1428 Probe <Probe> Post Invalid liquid aspi- Check probe conditions. If the problem persists,
Aspiration Baseline ration. LLD Baseline call Service.
Check Failure in rack read after liquid level
position <X>, track detection and after liq-
<YY>. uid aspiration is too
high: the probe did not
stay submerged.
Check Failure in read after liquid level
cuvette position detection and after liq-
<X>, slot <YY>. uid aspiration is too
stay submerged.
well position <well detection and after liq-
pos>. uid aspiration is too
stay submerged.
level in LAS Track. position of the liquid is
unexpected.
1432 Probe <Probe> Pre The probe detects liq- Check probe conditions. If the problem persists,
Aspiration Baseline uid but the measured call Service.
Check Failure in position of the liquid is
LAS Track. unexpected.
failure in LAS Track. line values read before
and after aspiration is
too high.



LAS Track. detection and after liq-
uid aspiration is too
stay submerged.
1435 Probe <Probe> Unexpected liquid Check probe conditions. If the problem persists,
unexpected liquid level in LAS arm cover call Service.
level in LAS arm aspiration point.
cover aspiration
point.
1436 Probe <Arm> Pre Invalid liquid detec- Check probe conditions. If the problem persists,
LAS Arm cover aspi- and after liquid detec-
ration point. tion is too low.
1437 Probe <Arm> aspi- Invalid liquid detec- Check probe conditions. If the problem persists,
failure in LAS Arm line values read before
cover aspiration and after aspiration is
point. too high.
1438 Probe <Arm> Post Invalid liquid aspi- Check probe conditions. If the problem persists,
LAS Arm cover aspi- detection and after liq-
ration point. uid aspiration is too
stay submerged.
1440 Probe <Probe> The probe detects clean Check probe conditions. If the problem persists,
unexpected clean but the measured posi- call Service.
level in rack position tion of the liquid is
<X>, track <YY>. unexpected.
2000 Rinse solution bottle Rinse fluid system liq- Replace the current Rinse bottle with a new one.
empty. uid EMPTY sensor DO NOT TOP OFF the Rinse bottle. It must be
detected. replaced when the instrument is not running. The
system will automatically detect the presence of a
new bottle. A prime cycle will be automatically
performed. If the rinse fluid level drops below
600 mL during a run, the system will perform a
controlled stop. In this case, wait until the anal-
ysis completes and the system comes to a com-

Alarm Messages

plete stop, then replace the Rinse bottle. If the

rinse fluid level drops below 100 mL, the system
will perform an emergency stop.
2005 Waste tank full. Waste Fluid Container Empty and replace the waste tank.
FULL sensor detected.
2006 Cannot empty waste Cannot Empty Waste Replace the waste tank.
into container. into Container
2015 Clean solution bottle Clean fluid system liq- Replace the current Clean bottle with a new one.
empty. uid EMPTY sensor The Clean bottle must be replaced when the
detected. instrument is not running. If the Clean bottle
emptied during a run, the system performs a con-
trolled stop: wait until the system comes to a com-
plete stop, replace the bottle with a new one, then
restart the analysis.
2020 Cuvette load area No cuvette strips Load cuvettes. The system performed a controlled
empty. detected at EMPTY sen- stop and two situations can occur when loading
sor in load area. new cuvettes:
- The cuvettes are loaded while the system is in

controlled stop. In this case the run is auto-
matically recovered (if there are tests pending to
be performed).
- The cuvettes are loaded when the system

already completed the analysis and went from con-
trolled stop to error. In this case the run has to be
restarted (if there are tests pending to be per-
formed).
2025 Cuvettes waste Cuvette waste drawer Insert cuvette waste drawer or make sure that it is
drawer missing. sensor defines waste properly inserted.
drawer not present
If the drawer is removed while the system is run-
ning, a controlled stop is performed and two sit-
uations can occur when re-inserting the drawer:
- The drawer is re-inserted when the system is in

controlled stop. In this case the run is auto-
matically recovered (if there are tests pending to
be performed).
- The drawer is re-inserted when the system


already completed the analysis and went from con-

trolled stop to error. In this case the run has to be
restarted (if there are tests pending to be per-
formed).
If the system needs to dispose used cuvettes

when the drawer is missing, an Emergency Stop is
performed. In this case perform a Recovery after
the cuvette drawer is re-inserted.
2030 Cuvette waste full. Cuvette waste drawer Empty cuvette waste drawer. The system per-
FULL sensor detected. formed a controlled stop and two situations can
occur when re-inserting the drawer: 1.- The
drawer is re-inserted when the system is in con-
trolled stop. In this case the run is automatically
recovered (if there are tests pending to be per-
formed). 2.- The drawer is re-inserted when the
system already completed the analysis and went
from controlled stop to error. In this case the run
has to be restarted (if there are tests pending to be
performed). If the system needs to dispose used
cuvettes when the drawer is missing, an Emer-
gency Stop is performed. In this case perform a
Recovery after the cuvette drawer is re-inserted.
2035 Cuvettes strip dro- Unable to Drop Off The system performed an Emergency stop. Per-
poff failure in posi- Cuvette in the form a Recovery. If the problem persists, call Serv-
tion <Cuvette Slot requested position. ice.
ID>.
2040 Cuvettes strip posi- The requested Cuvette The system performed an Emergency stop. Per-
tioning failure. move is not allowed form a Recovery. If the problem persists, call
Service.
2045 Cuvettes strip pickup Unable to Pickup The system performed an Emergency stop. Per-
failure in position Cuvette in the form a Recovery. If the problem persists, call Serv-
<Cuvette Slot ID>. requested position. ice.
2046 Insufficient Clean Clean volume in vial Load additional clean material.
volume in track detected to be at error
#<Track ID>, posi- threshold.
tion #<rack posi-
tion>.
2055 Insufficient volume Insufficient liquid for Make sure that there is enough material for the
in track #<Track the aspirate (sample or analysis and that it is presented in an appropriate
container.

Alarm Messages

ID>, position #<rack reagent)

position>.
2074 Insufficient volume Insufficient liquid for Check probe conditions. Make sure that there is
for sample <Sam- the sample aspiration enough sample for the analysis.
pleID> at Aspiration (LAS Track)
Point.
2075 Insufficient liquid in Insufficient Liquid Call Service.

cuvette <Cuvette detected when mixing
Slot ID> well <well is performed in a
position>. cuvette.
2076 Probe <Probe>: Insuf- Insufficient liquid for Perform a Clean prime cycle (Maintenance). If the
ficient volume in the aspirate (sample or problem persists call Service.
clean cup. reagent)
2077 Insufficient volume Insufficient liquid for Make sure that there is a vial at the aspiration
in LAS Arm cover the aspirate (LAS Arm point containing the appropriate volume of mate-
aspiration point. Cover) rial.
2083 <Material Name> Volume for last vial Load additional material.
insufficient material detected to be at error
to run additional cal- threshold. The volume
ibration / test. of liquid on-board for a
specific material is not
enough to run a single
job, so a new vial
should be placed.
3001 <Material Name> Volume for last vial Load additional material before the currently used
volume low. detected to be at warn- vial gets empty.
ing threshold.
3002 <Material Name> Remaining stability for Load fresh material before the stability elapses for
on-board stability last vial detected to be the currently used vial.
low. at warning threshold.
3003 <Material Name> Remaining expiration Load a new lot of material with later expiration
close to expiration. time for last vial/lot date before the currently used lot expires.
detected to be at warn-
ing threshold.
3004 Non-identified Mate- A material has been Manually define the material or remove rack, re-
rial in rack <rack inserted without a Bar- position the vial barcode and re-insert the rack.


ID> position <rack CodeID Label.

position #>, track #
<rack track #>.
3005 Unknown material in A material has been Remove the material and verify. Define material
rack <rack ID> posi- inserted with a Bar- prior to use in the system. Non-IL material should
tion <rack position CodeID label whose be used without barcodes.
#>, track # <rack Material Index does not
track #>. correspond to any mate-
rial definition in the
material list. In this
case the <Lot not
defined> alarm shall
not be triggered. Fol-
low Link to Data Dic-
tionary for further
information about Bar-
code ID contents.
If the bottle type con-

tained in the Bar Code
is not defined or is dis-
abled, this alarms will
be also displayed.
3006 New Bottle Type The Bottle Type con- The vial size has been automatically updated.
(<Material Name> in tained in the Bar Code Make sure that the fill volume defined in Material
rack <rack ID> posi- is different than the Bot- Definition is consistent with the new vial size.
tion <rack position tle Type defined in the Also the on-board stability definition may
#>, track # <rack material definition. change.
track #>).
3007 Unknown lot (<Mate- A material has been Remove material from the system. Verify that the
rial Name> in rack loaded on-board whose material is a defined lot in the system prior to
<rack ID> position lot is not defined in the loading.
<rack position #>, system. In this case the
track # <rack track Material ID contained
#>). in the Barcode Label is
known but the Lot Id is
not. Therefore the alarm
<Non-Referenced Mate-
rial> shall not be gen-
erated. Follow link to
Data Dictionary for fur-
ther information about
the contents of the Bar-

Alarm Messages

code ID.
3009 Placement error A material has been Remove the CAL/NPP and load it in a suitable
(<Material Name> in placed in a wrong rack position (See Restriction Map).
rack <rack ID>, posi- position.
tion <rack position
#>, track #<rack
track#>).
3010 Placement error A material has been Remove the QC and load it in a suitable position
(<Material Name> in placed in a wrong rack (See Restriction Map).
tion <rack position
#>, track #<rack
track#>).
3011 Placement error A material has been Remove the Sample Diluent and load it in a suit-
(<Material Name> in placed in a wrong rack able position (See Restriction Map).
tion <rack position
#>, track #<rack
track#>).
3012 Placement error A material has been Remove the Reagent Diluent and load it in a suit-
tion <rack position
#>, track #<rack
track#>).
3013 Placement error A material has been Remove the Intermediate Reagent and load it in a
(<Material Name> in placed in a wrong rack suitable position (See Restriction Map).
tion <rack position
#>, track #<rack
track#>).
3014 Placement error A material has been Remove the Start Reagent and load it in a suit-
tion <rack position
#>, track #<rack
track#>).
3015 Placement error A material has been Remove the Deficient Plasma and load it in a suit-


tion <rack position

#>, track #<rack
track#>).
3016 Placement error A material has been Remove the Clean Material and load it in a suit-
tion <rack position
#>, track #<rack
track#>).
3017 Placement error A material has been Remove the rack and load it in a suitable position
(<Material Name> in placed in a wrong rack (Start Reagents always to the right of Intermediate
rack <rack ID>, posi- position. Reagents and Deficient Plasma).
tion <rack position
#>, track #<rack
track#>).
3018 Placement error A material has been Remove the rack and load it in a suitable position
(<Material Name> in placed in a wrong rack (Intermediate Reagents and Deficient Plasma
rack <rack ID>, posi- position. always to the left of Start Reagents).
tion <rack position
#>, track #<rack
track#>).
3019 Placement error A material has been Remove the Start Reagent and load it on another
(<Material Name> in placed in a wrong rack rack (do not mix on the same rack Start Reagents
rack <rack ID>, posi- position. with Intermediate Reagents or Deficient Plasma).
tion <rack position
#>, track #<rack
track#>).
3020 Placement error A material has been Remove the Intermediate Reagent or Deficient
(<Material Name> in placed in a wrong rack Plasma and load it on another rack (do not mix
rack <rack ID>, posi- position. on the same rack Start Reagents with Intermediate
tion <rack position Reagents or Deficient Plasma).
#>, track #<rack
track#>).
3021 Placement error two lots of the same Remove the lot that you do not want to use.
(<Material Name> in material have been
rack <rack ID>, posi- placed on-board at the
tion <rack position same time.
#>, track #<rack
track#>).

Alarm Messages

3024 <TestCode> <Job- A job has been sent to Check the materials required for the assay or
Type> job not fea- AM and there is no place more reagents.
sible. Waiting for enough volume for
<material name>. some of the reagents or
a reagent is not placed.
Clean Materials are not
included in this alarm.
3025 <TestCode> Auto- An automatic job Check the materials required for the assay or
matic <JobType> job created by the AM not place more reagents.
not feasible. Waiting have enough volume
for <material name>. for some of the reagents
or a reagent is not
placed. Clean Materials
are not included in this
alarm.
3055 Placement error Material with vial pro- Review bottle type for possible bar code label/bot-
(<Material Name> in file different than 4mL tle type inconsistency. Use another position for
rack <rack ID>, posi- placed in a Diluent bottle placement.
tion <rack position rack Pos 3 to 8.
#>, track #<rack
track#>). Material with vial pro-
file equal to 30mL
placed in a non Diluent
rack or in Pos 3 to 8 of
a diluent rack.
3084 <Material Name> Remaining stability for Load fresh material.

on-board stability last vial expired.
expired for last avail-
able vial.
3085 <Material Name> The present date is Define a new active lot of material.
expired. greater than the expi-
ration date of the last Depending on the material, calibration, QC or
available vial/lot. NPP measurements may be required prior to run-
ning patient samples.
3086 <Material Name> A material requiring stir- Remove material and load it in a stirring-enabled
requires stirring (rack ring is placed in a posi- position (reagent rack positions 1 or 2, inserted in
<rack ID> position tion not having stirring track with stirring enabled).
<rack position #>, capability
track # <rack track
#>)


3096 <Test Code> is There was a pro- Check for test consistency and check if it is ena-
inconsistent/disable. grammed test incon- bled.
sistent/disabled and the
test was removed.
3097 <TestCode> <Job- Number of predilution Increase the number of predilution cuvette slots
Type> job cannot be cuvette slots is insuf- defined in the LAS Configuration Screen. Please
executed and was ficient to execute a cal- refer to the Operator's Manual for more guidance.
removed from sam- ibration or a parallelism
ple/material <Sample job.
ID/Material Name>.
Number of pre-
dilution cuvette slots
is insufficient.
3182 <Test Code> is There was a pro- Check for test consistency and check if it is ena-
inconsistent/disabled. grammed test for an bled.
LAS sample. The test
definition is incon-
sistent/disabled and the
test was removed.
3183 Sample volume for The LAS sample vol- Retrieve the LAS sample and introduce the sam-
<Test Code> <Job- ume required to com- ple to the instrument via a sample rack.
Type> job exceeds plete a single test
the limit of a cuvette cannot exceed 535 uL
cell.
3184 <TestCode> <Job- A job cannot start Load fresh sample.

Type> job not fea- because the LAS sam-
sible. Sample ple expired
<SampleID> has
expired.
3185 <TestCode> <Job- A job has been sent to Load fresh sample.
Type> job not fea- AM and there is not
sible. Waiting for enough sample volume.
sample <SampleId>.

Alarm Messages

3187 <TestCode> <Job- A job has been sent to Check the clean material volume periodically and
Type> Required AM and there is not replenish as needed.
Clean Material short- enough volume for a
age has been esti- required clean material
mated. Monitor or the clean is not
<material name> placed.
availability.
3215 LAS sample expi- The time that an LAS Load more sample.
ration time exceeded sample can remain on
for <Data Dictionary board has been
- SampleID>. exceeded.
4025 Clean solution level Clean fluid system liq- Replace Clean solution bottle before it empties.
low. uid WARN sensor The Clean bottle must be replaced when the
detected. instrument is not running. Removing the Clean
bottle while the instrument is running will cause
an Emergency Stop.
4030 Rinse solution level Rinse fluid system liq- Replace rinse solution bottle before it empties.
low. uid WARN sensor The Rinse bottle must be replaced when the
detected. instrument is not running. Removing the Rinse
bottle while the instrument is running will cause
an Emergency Stop.
4035 Cuvettes low in the No cuvette strips Load new cuvettes.

load area. detected at WARN sen-
sor in load area.
4040 Cuvette waste almost The level of cuvettes in Empty cuvette waste drawer before it gets full.
full. the waste drawer is
close to maximum
height
4050 Waste tank almost Waste fluid container Empty waste tank before it gets full.
full. WARN sensor detected
4056 Waste tank not Waste tank is not Replace waste container.
present. present.

Job Frequency Alarms

Job Frequency Alarms – Warnings and Errors
3053 Calibration due for <Test- Calibration frequency in the warning Perform a calibration
Code>. threshold. before it becomes over-
due.
3054 Normal Pool Plasma due for NPP frequency in the warning thresh- Run a Normal Pool
<TestCode>. old. Plasma before it
becomes overdue.
3056 Calibration of <Test Code> A calibration has been executed and Review and validate
completed: please review and requires validation from the user. calibration if required.
validate.
3057 Calibration of <Test Code> A calibration has been recalculated or

recalculated. edited.
3058 Calibration of <Test Code> A calibration has been manually val-

validated. idated.
3059 Calibration of <Test Code> A calibration has been completed and

completed and autovalidated. autovalidated.
3090 Calibration Overdue for <Test- Frequency expired for the active val- Perform a calibration
Code>. idated calibration. job using active lots
and validate it.
3091 Normal Pool Plasma Overdue The NPP frequency has expired. Perform a Normal Pool
for <TestCode>. Plasma job.
3094 Calibration for <Test Code> A Calibration was active and it was Recalibrate (even if
interrupted. manually or automatically interrupted. frequency is Ok).
3095 Autovalidation of completed A calibration has been completed and Review and validate
calibration for <Test Code> the autovalidation failed. calibration if required.
failed.
3098 <TestCode> <JobType> job A patient job has been sent to AM and Validate a calibration
not feasible. Calibration not there is no validated calibration for the for the on-board lots.
available. on board lots.
3099 <TestCode> <JobType> job A patient job has been sent to AM and Run QC jobs.
not feasible. QC Failed for there is a QC failed for that test.
<material name>.

Alarm Messages
QC Alarms
QC Alarms – Warnings and Errors
3026 QC Due : <TestCode>- The expiration time to per- Run QC before it becomes overdue.
<MaterialName> form a QC job has entered in
its threshold period.
3027 QC Frequency OK : <Test- Transition from QC

Code>-<MaterialName> frequency Overdue/Due to
OK
3028 QC Omitted point: <Test- QC result omitted

Code>-<MaterialName>
3029 QC Point restored:<Te- An omitted QC result has

stCode>-<MaterialName> been re-enabled.
3030 QC Results purged until QC results have been purged.

<limitDate> : <TestCode>-
<MaterialName>.
3087 QC Overdue: <TestCode>- The expiration date for a QC Perform QC.

<MaterialName> has been reached.
3088 QC Failed: <TestCode>- QC rules have failed. It is a Review QC results, statistics and
<MaterialName> hint to detect problems in the graphs. Based on the situation, take
measurement. proper corrective actions.

Maintenance Alarms
Maintenance Alarms – Warnings and Errors
2086 Maintenance activity inter- A semi-Automatic or automatic Main- The activity has not
rupted: <Maintenance tenance Activity's Execution has been been completed. Remove
Activity> interrupted due to an error. the cause of the error
and re-select the activity.
3047 Maintenance activity due: An indicated maintenance activity shall Perform maintenance
be executed by the user. The expiration activity before it
<Maintenance Activity>. time to perform the activity has entered becomes overdue.
in its threshold period.
3048 Manual maintenance activ- A new manual maintenance activity has

ity <Maintenance Activity been defined and added by the user.
Name> has been added.
3049 Manual maintenance activ- A manual maintenance Activity has been

ity <Maintenance Activity deleted by the user.
Name> has been deleted.
3050 Maintenance activity A maintenance activity has been recon-

<Maintenance Activity figured. Their values might be changed.
Name> has been con-
figured.
3051 Frequency status for man- The frequency status of a maintenance

ual maintenance activity activity has changed to OK.
<Maintenance Activity
Name> has changed to
OK.
3052 Manual maintenance activ- A maintenance activity has been

ity <Maintenance Activity executed either manually by the user or
Name> has been executed. automatically by the system.
3089 Maintenance activity over- An indicated Maintenance Activity Perform the maintenance
due: should already have been executed by activity.
the user. The expiration date for a Main-
<Maintenance Activity>. tenance Activity has been reached.
3216 Semiautomatic main- A maintenance activity has been

tenance activity <Main- executed either manually by the user or
tenance Activity Name> automatically by the system.
has been executed.

Alarm Messages
Maintenance Alarms – Warnings and Errors

3217 Automatic maintenance A maintenance activity has been

activity <Maintenance executed either manually by the user or
Activity Name> has been automatically by the system.
executed.

Analyzer Alarms
Analyzer Alarms – Warnings and Errors

Code Message Alarm Descrip- Cause Operator Action
tion
0000 Analyzer / Con- A non-recov- Communication Check communication cable.

trol Module loss erable error cable dis-
of com- occurred in the connection. Soft- Power off and restart the
munication. CM/AM Com- ware or electronic instrument.
munications failure.
Manager (e.g. If the problem persists, call
loss of con- Service.
nection).
If the instru-
ment is in Emer-
gency Stop this
alarm is not
reported.
0005 Master controller Failure of LRC Master controller Power off and restart the
failure. or CRC check. board malfunction. instrument.
If the problem persists, call

Service.
0007 <Arm> Arm con- One of the AM Arm controller Power off and restart the
troller initial- processors failed board did not pass instrument.
ization failure. to initialize, due initialization tests.
to an Invalid If the problem persists, call
Controller ID. Service.
0010 Rack-Cuvette con- One of the AM Rack-Cuvette con- Power off and restart the
troller initial- processors failed troller board did instrument.
ization failure. to initialize, due not pass initial-
to an Invalid ization tests. If the problem persists, call
0011 Cuvettes con- One of the AM Cuvettes controller Power off and restart the
troller initial- processors failed board did not pass instrument.
ization failure. to initialize, due initialization tests.

Alarm Messages

tion
0012 Racks controller One of the AM Racks controller Power off and restart the
initialization fail- processors failed board did not pass instrument.
ure. to initialize, due initialization tests.
0013 Optical Reading One of the AM Optical Reading Power off and restart the
Units controller processors failed Units controller instrument.
initialization fail- to initialize, due board did not pass
ure. to an Invalid initialization tests. If the problem persists, call
0014 <Arm> Arm Con- Invalid param- Built-in checks in Power off and restart the
troller software eter provided in the software instrument.
error. a function call, detected an unre-
message queue coverable error. If the problem persists, call
or inter-task com- Service.
munication
mechanism.
0015 Master Controller Invalid param- Built-in checks in Power off and restart the
software error. eter provided in the software instrument.
a function call, detected an unre-
munication
mechanism.
0016 Cuvettes Con- Invalid param- Built-in checks in Power off and restart the
troller software eter provided in the software instrument.
error. a function call, detected an unre-
munication
mechanism.


tion
0017 Racks Controller Invalid param- Built-in checks in Power off and restart the
software error. eter provided in the software instrument.
a function call, detected an unre-
munication
mechanism.
0018 Optical Reading Invalid param- Built-in checks in Power off and restart the
Units Controller eter provided in the software instrument.
software error. a function call, detected an unre-
munication
mechanism.
0019 Rack-Cuvette Invalid param- Built-in checks in Power off and restart the
Controller soft- eter provided in the software instrument.
ware error. a function call, detected an unre-
munication
mechanism.
0020 Analyzer internal A non-recov- Built-in checks in Power off and restart the
communication erable error the software instrument.
error. occurred in the detected an unre-
Controller Com- coverable error. If the problem persists, call
munications Service.
Manager or the
low level CAN
bus driver
(master or con-
troller side.
0025 Master Controller Memory allo- Built-in checks in Power off and restart the
software error. cation failed or the software instrument.
stack usage detected an unre-
exceeds limit. coverable error. If the problem persists, call
Service.
0030 Master Controller Error detected Built-in checks in Power off and restart the
software error. when calling ker- the software instrument.
nel facilities. detected an unre-
coverable error. If the problem persists, call

Alarm Messages

tion
Service.
0031 Cuvettes Con- Error detected Built-in checks in Power off and restart the
troller software when calling ker- the software instrument.
error. nel facilities. detected an unre-
Service.
0032 Racks Controller Error detected Built-in checks in Power off and restart the
software error. when calling ker- the software instrument.
nel facilities. detected an unre-
Service.
0033 Optical Reading Error detected Built-in checks in Power off and restart the
Units Controller when calling ker- the software instrument.
software error. nel facilities. detected an unre-
Service.
0034 Rack-Cuvette Error detected Built-in checks in Power off and restart the
Controller soft- when calling ker- the software instrument.
ware error. nel facilities. detected an unre-
Service.
0035 Master Controller Software logic Built-in checks in Power off and restart the
software error. error such as an the software instrument.
invalid path in a detected an unre-
switch statement coverable error. If the problem persists, call
or if.else Service.
branch.
0036 Cuvettes Con- Software logic Built-in checks in Power off and restart the
troller software error such as an the software instrument.
error. invalid path in a detected an unre-
or if.else Service.
branch.
0037 Racks Controller Software logic Built-in checks in Power off and restart the
software error. error such as an the software instrument.
invalid path in a detected an unre-
or if.else Service.
branch.


tion
0038 Optical Reading Software logic Built-in checks in Power off and restart the
Units Controller error such as an the software instrument.
software error. invalid path in a detected an unre-
or if.else Service.
branch.
0039 Rack-Cuvette Software logic Built-in checks in Power off and restart the
Controller soft- error such as an the software instrument.
ware error. invalid path in a detected an unre-
or if.else Service.
branch.
0040 Master Controller Invalid state for Built-in checks in Power off and restart the
software error. an event, func- the software instrument.
tion call, mes- detected an unre-
sage, etc coverable error. If the problem persists, call
Service.
0041 Cuvettes Con- Invalid state for Built-in checks in Power off and restart the
troller software an event, func- the software instrument.
error. tion call, mes- detected an unre-
Service.
0042 Racks Controller Invalid state for Built-in checks in Power off and restart the
software error. an event, func- the software instrument.
tion call, mes- detected an unre-
Service.
0043 Optical Reading Invalid state for Built-in checks in Power off and restart the
Units Controller an event, func- the software instrument.
software error. tion call, mes- detected an unre-
Service.
0044 Rack-Cuvette Invalid state for Built-in checks in Power off and restart the
Controller soft- an event, func- the software instrument.
ware error. tion call, mes- detected an unre-
Service.
0045 Master Controller It was detected Built-in checks in Power off and restart the

Alarm Messages

tion
software error. that there is a the software instrument.

potential for a detected an unre-
stack problem. coverable error. If the problem persists, call
Service.
0046 Cuvettes Con- It was detected Built-in checks in Power off and restart the
troller software that there is a the software instrument.
error. potential for a detected an unre-
Service.
0047 Racks Controller It was detected Built-in checks in Power off and restart the
software error. that there is a the software instrument.
potential for a detected an unre-
Service.
0048 Optical Reading It was detected Built-in checks in Power off and restart the
Units Controller that there is a the software instrument.
software error. potential for a detected an unre-
Service.
0049 Rack-Cuvette It was detected Built-in checks in Power off and restart the
Controller soft- that there is a the software instrument.
ware error. potential for a detected an unre-
Service.
0050 Master Controller The command Built-in checks in Power off and restart the
software error. received is not the software instrument.
supported. detected an unre-
Service.
0051 Cuvettes Con- The command Built-in checks in Power off and restart the
troller software received is not the software instrument.
error. supported. detected an unre-
Service.
0052 Racks Controller The command Built-in checks in Power off and restart the
software error. received is not the software instrument.
supported. detected an unre-
Service.


tion
0053 Optical Reading The command Built-in checks in Power off and restart the
Units Controller received is not the software instrument.
software error. supported. detected an unre-
Service.
0054 Rack-Cuvette The command Built-in checks in Power off and restart the
Controller soft- received is not the software instrument.
ware error. supported. detected an unre-
Service.
0056 Interrupted com- The CM has lost Communication Check communication cable
munication the connection cable disconnected. connection. Verify that the
between the with the AM Analyzer powered Analyzer is powered on.
Analyzer and the module. off. Other hard- Restart the system (both
Control Module. ware/software com- Analyzer and Control Mod-
munication ule); if the problem persist call
problems. Service.
0057 Optical Reading One of the wave- Built-in checks in Power off and restart the
Units Controller lengths not used the software instrument.
software error. in ORU acqui- detected an unre-
sitions. coverable error. If the problem persists, call
Service.
0058 Controller <Con- Controller Controller Upgrade Call Service.

troller Name> Upgrade has has failed.
upgrade failure. failed since
downloaded SW
version does not
match SW ver-
sion actually
used. The AM
reported an
exception dur-
ing the upgrade
process.
The AM not
responding dur-
ing controllers
upgrade. There
is a 1 min time-

Alarm Messages

tion
out.
AM/CM loss of
communications
during upgrade
process.
0061 <Arm> Arm Con- Error detected Built-in checks in Power off and restart the
troller software when calling ker- the software instrument.
error. nel facilities. detected an unre-
Service.
0065 <Arm> Arm Con- Software logic Built-in checks in Power off and restart the
troller software error such as an the software instrument.
error. invalid path in a detected an unre-
or if.else Service.
branch.
0070 <Arm> Arm Con- Invalid state for Built-in checks in Power off and restart the
troller software an event, func- the software instrument.
error. tion call, mes- detected an unre-
Service.
0075 <Arm> Arm Con- It was detected Built-in checks in Power off and restart the
troller software that there is a the software instrument.
error. potential for a detected an unre-
Service.
0080 <Arm> Arm Con- The command Built-in checks in Power off and restart the
troller software received is not the software instrument.
error. supported. detected an unre-
Service.
0084 Incompatible AM Incompatible AM Master version Call Service.

Master software interface version is incompatible
version. Detected between with current CM
interface version AM/CM software.
<Interface Ver-
sion> and
expected <Inter-
face Version>.


tion
0085 Incompatible Incompatible A controller ver- Call Service.

<Controller interface version sion is incom-
Name> controller between a con- patible with current
version. troller and the AM Master soft-
AM Master software.
ware
0086 Material <Mate- SW detected a There was a soft- If the problem persists, call
rial Name> not material that ware scheduling Service.
dispensed. was not dis- conflict.
pensed
1001 <Arm> Arm fail- The arm is Software or mechan- The system performed an Emer-
ure. inoperable. ical gency stop. Perform a
error. Initialization Recovery. If the problem per-
error. sists, call Service.
ure. inoperable. ical error. gency stop. Perform a
Recovery. If the problem per-
Invalid Command. sists, call Service.
Invalid Operand. sists, call Service.
Invalid command sists, call Service.
sequence.
Device not imple- sists, call Service.
mented.
Timeout error. sists, call Service.

Alarm Messages

tion
Device not initial- sists, call Service.
ized.
Command over- sists, call Service.
flow.
Recovery. The system per-
No liquid detected formed an Emergency stop. Per-
with ZX command. form a Recovery. If the
problem persists, call Service.
Entered move for sists, call Service.
Z-axis out of range.
Not enough liquid sists, call Service.
detected with ZX
command.
No liquid detected sists, call Service.
with ZZ command.


tion
Not enough liquid sists, call Service.
detected with ZZ
command.
Arm collision sists, call Service.
avoided.
Step loss on X sists, call Service.
axis.
Step loss on Y sists, call Service.
axis.
Step loss on Z sists, call Service.
axis.
Step loss detected sists, call Service.
on X-axis of oppos-
ing arm.
ALDIUM pulse sists, call Service.
time out.

Alarm Messages

tion

Tip not fetched. sists, call Service.
Tip crash. sists, call Service.
Tip not clean. sists, call Service.
Undefined error sists, call Service.
code reported.
Communication sists, call Service.
timeout.
1031 <Syringe> The pump used Software or mechan- The system performed an Emer-
Syringe failure. to aspir- ical gency stop. Perform a
ate/dispense error. Initialization Recovery. If the problem per-
fluids is error. sists, call Service.
inoperable.
Syringe failure. to aspir- ical error. Invalid gency stop. Perform a
ate/dispense command. Recovery. If the problem per-
fluids is sists, call Service.
inoperable.
ate/dispense operand. Recovery. If the problem per-
inoperable.
ate/dispense command sequence. Recovery. If the problem per-


tion

inoperable.
1035 <Syringe> Fluid Detection The sensor board The system performed an Emer-
Syringe failure. Error. This error detects fluid, which gency stop. Perform a
occurs when the is caused by leak- Recovery. If the problem per-
sensor board ing out the back of sists, call Service.
detects fluid, the valve.
which is caused
by leaking out
the back of the
valve.
1036 <Syringe> EEPROM Fail- EEPROM is faulty. The system performed an Emer-
Syringe failure. ure. This error gency stop. Perform a
occurs when the Recovery. If the problem per-
EEPROM is sists, call Service.
faulty.
Syringe failure. to aspir- ical error. Device gency stop. Perform a
ate/dispense not initialized. Recovery. If the problem per-
inoperable.
Syringe failure. to aspir- ical error. Com- gency stop. Perform a
ate/dispense mand overflow. Recovery. If the problem per-
inoperable.
1039 <Syringe> Asyn- Syringe Pump Asynchronous dis- The system performed an Emer-
chronous dis- and ORU con- pensation in ORU gency stop. Perform a
pensation in troller com- failure. Recovery. If the problem per-
ORU. munications sists, call Service.
failure.
Syringe failure. to aspir- ical error. Com- gency stop. Perform a
ate/dispense munication Recovery. If the problem per-
fluids is timeout. sists, call Service.
inoperable.
1041 The Optical Read- The ORU Head The ORU has been
ing Unit <ORU has been dis- disabled. User
ID> has been disabled. request.

Alarm Messages

tion
abled.
1042 The Optical Read- The ORU Head The ORU has been Call Service.
ing Unit <ORU has been dis- disabled. Air read-
ID> has been disabled due to ing out of range
abled. low air limit. (low).
ID> has been disabled due to due ing out of range
abled. to a high air (high).
limit.
ID> has been disabled due to air ing drift (low)
abled. drift low limit. detected.
ID> has been disabled due to air ing drift (high)
abled. drift high limit. detected.
ing Unit <ORU has been dis- disabled. Detector
ID> has been disabled due to an voltage error
abled. ORU voltage detected.
problem.
1047 <Syringe> Plunger Over- Movement of the The system performed an Emer-
Syringe failure. load. This error syringe plunger gency stop. Perform a
occurs when was blocked by Recovery. If the problem per-
movement of the excessive pressure. sists, call Service.
syringe plunger
is blocked by
excessive pres-
sure.
1048 <Syringe> Valve Overload. Valve drive loses The system performed an Emer-
Syringe failure. This error occurs steps by blockage gency stop. Perform a
when the valve or excess back pres- Recovery. If the problem per-
drive loses steps sure. sists, call Service.
by blockage or
excess back pres-
sure. Continual
valve overload


tion
errors are an indi-

cation the valve
should be
replaced.
1049 <Syringe> Plunger Move Plunger Move Not The system performed an Emer-
Syringe failure. Not Allowed. Allowed. When the gency stop. Perform a
When the valve valve is in bypass Recovery. If the problem per-
is in bypass or or throughput posi- sists, call Service.
throughput position plunger move-
tion plunger ment commands are
movement com- not allowed.
mands are not
allowed.
1050 <Syringe> Command Over- Command Over- The system performed an Emer-
Syringe failure. flow. This error flow. This error gency stop. Perform a
occurs when the occurs when the Recovery. If the problem per-
command buffer command buffer sists, call Service.
contains too contains too many
many characters. characters.
1100 Optical reading Voltage out-of- Voltage out of Call Service.

units voltage con- range fault range in optical
trol failure. detected. reading units.
1105 Arm com- RS232 com- Software or Hard- Call Service.

munication error. munications ware failure.
error with arms
1110 Cuvettes incu- Incubator tem- Temperature out of Call Service.

bator No. 1 temperature defined range in cuvette
perature control to be out of incubator.
failure. range for a
period exceed-
ing the fatal
error limits.
1111 Cuvettes incu- Incubator tem- Temperature out of Call Service.

bator No. 2 temperature defined range in cuvette
perature control to be out of incubator.
period exceed-
ing the fatal
error limits.

Alarm Messages

tion
1115 Optical reading ORU tem- Temperature out of Call Service.

unit No. 1 temperature defined range in optical
perature control to be out of reading unit.
period exceed-
ing the fatal
error limits.

period exceed-
ing the fatal
error limits.

period exceed-
ing the fatal
error limits.

period exceed-
ing the fatal
error limits.
1120 Cuvette shuttle Cuvette Shuttle Cuvette shuttle tem- The system performed a con-
temperature con- temperature perature out of trolled stop: the run has to be
trol failure. defined to be range. re-started. If the problem per-
out of range for sists, call Service.
a period exceed-
ing the fatal
error limits.
1125 Reagent area tem- Reagent Area Reagent area tem- The system performed a con-
perature control temperature perature out of trolled stop: the run has to be
failure. defined to be range. re-started. If the problem per-
out of range for sists, call Service.


tion
a period exceed-
ing the fatal
error limits.
1130 Optical reading Detector inter- Built-in checks Call Service.

units data acqui- face fault, e.g. detected an error.
sition control fail- conversion did
ure. not complete,
emitter light
source not cor-
rect.
1131 <Arm> Arm con- CRC Error Arm controller Call Service.
troller failure. detected in writ- board malfunction.
ing to or reading
from a per-
manent storage
device (e.g. EEP-
ROM)
1135 Cuvettes con- CRC Error Cuvettes controller Call Service.

troller failure. detected in writ- board malfunction.
ing to or reading
from a per-
manent storage
device (e.g. EEP-
ROM)
1136 Racks controller CRC Error Racks controller Call Service.

failure. detected in writ- board malfunction.
ing to or reading
from a per-
manent storage
device (e.g. EEP-
ROM)
1137 Optical Reading CRC Error Optical Reading Call Service.

Units controller detected in writ- Units controller
failure. ing to or reading board malfunction.
from a per-
manent storage
device (e.g. EEP-
ROM)
1138 Rack-Cuvette con- CRC Error Rack-Cuvette con- Call Service.

troller failure.

Alarm Messages

tion
detected in writ- troller board mal-

ing to or reading function.
from a per-
manent storage
device (e.g. EEP-
ROM)
1139 Rack-Cuvette con- Error detected in Rack-Cuvette con- Call Service.

troller failure. updating data troller board mal-
on a permanent function.
storage device
(e.g. EEPROM)
1140 Cuvettes con- Error detected in Cuvettes controller Call Service.

troller failure. updating data board malfunction.
on a permanent
storage device
(e.g. EEPROM)
1141 Racks controller Error detected in Racks controller Call Service.

failure. updating data board malfunction.
on a permanent
storage device
(e.g. EEPROM)
1142 Optical Reading Error detected in Optical Reading Call Service.

Units controller updating data Units controller
failure. on a permanent board malfunction.
storage device
(e.g. EEPROM)
1143 <Arm> Arm con- Error detected in Arm controller Call Service.
troller failure. updating data board malfunction.
on a permanent
storage device
(e.g. EEPROM)
1151 <Arm> Arm con- Voltage out-of- Arm controller Call Service.
troller voltage out range fault board malfunction.
of range. detected on a
controller.
NOTE: Micro-
TOP shall have
one arm con-


tion
troller only.
Therefore, the
term 'Instrument
Arm' shall be
used.
1155 Cuvettes con- Voltage out-of- Cuvettes controller Call Service.

troller voltage out range fault board malfunction.
of range. detected on a
controller.
1156 Racks controller Voltage out-of- Racks controller Call Service.

voltage out of range fault board malfunction.
range. detected on a
controller.
1157 Optical Reading Voltage out-of- Optical Reading Call Service.

Units controller range fault Units controller
voltage out of detected on a board malfunction.
range. controller.
1158 Rack-Cuvette con- Voltage out-of- Rack-Cuvette con- Call Service.

troller voltage out range fault troller board mal-
of range. detected on a function.
controller.
1160 Probe <Probe> Automatic coor- Probe coordinates The probe cannot initialize.
coordinates error. dinates check mismatch. Perform a probe alignment. If
failure the problem persists, call Serv-
ice.
1161 Wash station coor- Wash station Conductivity fail- Wipe down probe tip and
dinates error. coordinates ure between probe clean station.
error. and wash station
bracket.
1165 Probe <Probe> AM coordinates Coordinate adjust- Service or Lab Administrator

coordinate adjust have never been ment procedure not to run the Coordinate Adjust
required. adjusted using executed or failed. procedure.
the "Coordinate
adjustment" pro-
cedure.
1166 Missing coor- Until the user The coordinates of Service or Lab Administrator
dinates of aspi- defines the coor- the aspiration point to run the Coordinate Adjust
ration point in dinates of the on the LAS track procedure for LAS track posi-

Alarm Messages

tion
track. aspiration point are not defined. tion.

on the LAS
track, the instru-
ment is unable
to move the
LAS probe
there.
1170 Invalid system Invalid emitter, System detected a Check system configuration
configuration. detection, or hardware con- settings.
incubator mod- figuration that can-
ule con- not support the Power off and restart the
figuration current system con- instrument.
detected, or ref- figuration settings:
erence channel missing or inactive If the problem persists, call
not on installed optical reading Service.
detection mod- unit(s), cuvettes
ule. incubator or CTS
module.
1175 <Probe> probe Probe Pre-Heater Probe pre-heating The system performed a con-
pre-heater tem- temperature system malfunction. trolled stop. Call Service.
perature control defined to be
failure. out of range for
a period exceed-
ing the fatal
error limits.
1180 <Probe> probe Probe tem- Probe heating sys- The system performed a con-
temperature con- perature defined tem malfunction. trolled stop. Call Service.
trol failure. to be out of
range for a
period exceed-
ing the fatal
error limits.
1185 <Arm> arm clean Valve com- Clean fluid valve The system performed an Emer-
fluid valve fail- manded not responding. gency stop. Perform a
ure. ON(OFF) but Recovery. If the problem per-
sensor did not sists, call Service.
indicate
ON(OFF) state.


tion
NOTE: Mini-
TOP and Micro-
TOP have no
valves.
1190 Sample Clean Pump com- Clean pump not The system performed an Emer-
pump failure. manded responding. gency stop. Perform a
ON(OFF) but Recovery. If the problem per-
indicate
ON(OFF) state.
NOTE:
BaseTOP, CTS,
LAS, MiniTOP
and MicroTOP
have:
Sample Clean
Pump
Reagent Clean
Pump
1191 Reagent clean Pump com- Clean pump not The system performed an Emer-
indicate
ON(OFF) state.
1200 <Arm> arm rinse Pump com- Rinse pump not The system performed an Emer-
indicate
ON(OFF) state.
NOTE: For

Alarm Messages

tion
Micro there is
only 1 pump.
<Arm> will be
empty. Ter-
minology for
MicroTOP shall
be 'Instrument
Arm'
1205 Waste pump fail- Pump com- Waste pump not The system performed an Emer-
ure. manded responding. gency stop. Perform a
indicate
ON(OFF) state.
1206 Coordinate File Failure saving Invalid FTP server Call Service.
Saving Failure. coordinates file configuration,
on the FTP AM/CM con-
server nection network
not working.
1207 ORU Stored Read- Failure saving Invalid FTP server Call Service.
ing File Saving ORU stored read- configuration,
Failure. ing file on the AM/CM con-
FTP server nection network
not working.
1208 CTS sample arm Pump com- Air pump not The system performed an Emer-
air pump failure. manded responding. gency stop. Perform a
indicate
ON(OFF) state.
1209 CTS Failed to The foot hit the The foot hit the The system performed an Emer-
Enter Deep Wash. wash station wash station edge gency stop. Perform a
edge when the when the CTS Recovery. If the problem per-
CTS probe was probe was inserted sists, call Service.
inserted inside inside the wash sta-
the wash station. tion.
This would have
caused a probe
mode switch fail-
ure at the end of


tion
the wash cycle.
1236 Cuvette Pivot Failure on pivot Pivot Arm The system performed a con-
Arm failure. arm movement. malfunction. Either trolled stop: the run has to be
the motor, pivot re-started. If the problem per-
arm up sensor, or sists, call Service.
pivot arm down sen-
sor is not func-
tioning.
1237 Cuvette indexer Failure of the Cuvette indexer The system performed a con-
motor failure. indexer motor motor failure. trolled stop: the run has to be
detected. re-started. If the problem per-
sists, call Service.
1238 Cuvette Loader Failure moving Cuvette loader mal- The system performed a con-
Failure. cuvette loader function. Some trolled stop: the run has to be
belts detected. cuvettes strips may re-started. If the problem per-
not have been sists, call Service.
placed properly in
the loader, belts
motor or cuvette
loader sensors mal-
function.
1243 Cuvettes shuttle The motor did Cuvette was not The system performed an Emer-
movement failure. not complete the detected in the shut- gency stop. Perform a
requested move. tle after a cuvette Recovery. If the problem per-
pickup operation sists, call Service.
completed. OR
Cuvette was not
detected in the
cuvette shuttle
prior to a cuvette
drop off.
1244 Cuvettes shuttle The motor did Unexpected cuvette The system performed an Emer-
movement failure. not complete the present. gency stop. Perform a
requested move. Recovery. If the problem per-
1245 Cuvettes shuttle The motor did The motor moved The system performed an Emer-
movement failure. not complete the to the left limit gency stop. Perform a
requested move. then to the home Recovery. If the problem per-
position at the sists, call Service.

Alarm Messages

tion
loader and the

home position was
not found.
1246 Cuvettes shuttle The motor did Incorrect # slots The system performed an Emer-
movement failure. not complete the found. gency stop. Perform a
1247 Cuvettes shuttle The motor did Home Required. A The system performed an Emer-
movement failure. not complete the cuvette shuttle oper- gency stop. Perform a
requested move. ation was requested Recovery. If the problem per-
before the shuttle sists, call Service.
was initialized into
a known state.
1248 Cuvettes shuttle The motor did Cuvettes shuttle The system performed an Emer-
movement failure. not complete the movement timeout. gency stop. Perform a
requested move. Move Timeout. Recovery. If the problem per-
This occurs if the sists, call Service.
software does not
complete the move
profile.
movement failure. not complete the movement stalled. gency stop. Perform a
movement failure. not complete the movement hit gency stop. Perform a
requested move. unexpected travel Recovery. If the problem per-
limit. sists, call Service.
requested move. Gripper back sensor Recovery. If the problem per-
failure. sists, call Service.
requested move. Gripper forward sen- Recovery. If the problem per-
sor failure. sists, call Service.


tion
requested move. Gripper move fail- Recovery. If the problem per-

ure. sists, call Service.
1254 Cuvette waste Accumulator is Cuvette waste door Please check that the cuvette
accumulator full and unable open or cuvette waste drawer is present and
unable to empty. to dump waste drawer miss- cuvette waste door is closed.
ing.
1255 Barcode reader The motor did Barcode reader Clear obstruction and wait for
movement failure. not complete the movement timeout. barcode reader timeout to
requested move Home Not Found. occur (homing of barcode). If
prior to a motor problem persists call Service.
move time out
(bar code).
requested move Incorrect Slots occur (homing of barcode). If
prior to a motor Found. problem persists call Service.
move time out
(bar code).
requested move Home Required. occur (homing of barcode). If
prior to a motor problem persists call Service.
move time out
(bar code).
requested move occur (homing of barcode). If
prior to a motor Move Timeout. problem persists call Service.
move time out
(bar code).
prior to a motor Stalled. problem persists call Service.
move time out
(bar code).

Alarm Messages

tion
prior to a motor Unexpected Travel problem persists call Service.

move time out Limit.
(bar code).
1261 All the Optical All the ORU All the ORUs have If the ORUs have been auto-
Reading Units are have been dis- been disabled, matically disabled, call Serv-
disabled. Anal- abled, either either automatically ice.
ysis cannot be per- manually or or manually.
formed. automatically. When all the ORUs are dis-
- Automatically: abled the system cannot per-
The instrument ORU real-time form analysis.
cannot perform check failed
any tests. If this occurs during a run, the
- Manually: oper- system performs an Emergency
ator disabled ORU Stop.
through Diag-
nostics
1263 Cuvettes accumu- The accumulator Cuvettes accumu- The system performed an Emer-
lator failure. does not return lator movement gency stop. Perform a
to the up posi- timeout. Recovery. If the problem per-
tion within 2 sists, call Service.
seconds of being
emptied.
1264 Optical reading Temperature out Temperature out of Call Service.

unit No. 1 tem- of range in a range in optical
perature control reading unit reading unit.
failure.

failure.

failure.

failure.
1268 Cuvettes incu- Temperature out Temperature out of Call Service.


tion
bator No. 1 tem- of range in an range in cuvettes

perature control incubator incubator.
failure.
1269 Cuvettes incu- Temperature out Temperature out of Call Service.

bator No. 2 tem- of range in an range in cuvettes
perature control incubator incubator.
failure.
1270 <Probe> probe Probe tem- Probe heating sys- Call Service.
temperature or dis- perature or dis- tem malfunction.
pense temperature pense
out of range. temperature
defined to be
out of warning
range but within
failure range.
1273 <Probe> probe Probe Pre-Heater Probe pre-heating Call Service.

pre-heater tem- temperature system malfunction.
perature out of defined to be
range. out of warning
range but within
failure range
1276 Reagent area tem- Reagent area Reagent cooling Call Service.
perature out of temperature system malfunction.
range. defined to be
out of warning
range but within
failure range.
1277 Cuvette shuttle Cuvette shuttle Cuvette shuttle Call Service.

temperature out temperature heating system mal-
of range. defined to be function.
out of warning
range but within
failure range.
1278 Optical reading Optical Ref- LED or electronic Call Service.

units reference erence readings failure.
readings out of not within
range for ORU expected range,
<ORU ID>. possibly due to
LED aging or
failure.

Alarm Messages

tion
1279 Optical reading ORU dark read- Stray light inter- Call Service.
unit <ORU ID> ings are too ference or elec-
dark readings too high, possibly tronic failure.
high. indicating exces-
sive stray light.
1280 Optical reading Optical readings LED or electronic Call Service.

units readings too too noisy, pos- failure.
noisy for ORU sibly due to
<ORU ID>. LED aging or
failure.
1281 Optical reading ORU amplifier ORU LED or elec- Call Service.
unit <ORU ID> and/or A/D con- tronic failure.
readings out of verter saturated Amplifier and/or
range. A/D converter sat-
urated.
1283 Optical reading Math exception If the problem persists, call

unit raw data cal- error (e.g. Service.
culation error. attempt to
divide by zero,
overflow, result
not reasonable).
1284 Air read drift Current air read ORU air reading Go to diagnostics, clean the
detected for for this wave- drift detected. ORU channels, enable the
ORU# <ORU length, read ORU in question and repeat
ID> Channel# head and read the blanking procedures (AIR
<CHAN ID> channel is out- and Factor Diluent).
Wavelength# side of the
<WAVE ID> stored air read
Drift percentage plus tolerance
<DRIFT PER-
CENTAGE>


tion
1295 Air read out of Current air read ORU air reading Call Service.
range for ORU# for this wave- out of range.
<ORU ID> Chan- length, read
nel# <CHAN head and read
ID> Wavelength# channel is out of
<WAVE ID> range
Reading: <ORU
READING>
1313 Failed to load When attempt- Either motor could The system performed an Emer-
cuvette clip at the ing to move the have stalled, sensor gency stop. Perform a
indexer. cuvette indexer was not reached, or Recovery. If the problem per-
to pick up a sensor is not func- sists, call Service.
new cuvette tional.
clip, the indexer
was not detected
to be fully to
the left to allow
the clip to fall.
Move is
attempted for
five seconds in
order to search
for the proper
position.
1314 Failed to place When the Either the motor The system performed an Emer-
cuvette clip in cuvette indexer could have stalled, gency stop. Perform a
position for is attempting to the sensor was not Recovery. If the problem per-
pickup. load the cuvette reached, or the sen- sists, call Service.
clip into the sor is not func-
position for the tional.
cuvette shuttle
to pick it up, the
clip was not
detected. Move
is attempted for
five seconds in
order to search
for the proper
position.
1315 Pivot arm did not The move of the Either the motor The system performed an Emer-
move to the up pivot arm to the was stalled or the gency stop. Perform a
position. up sensor is not Recovery. If the problem per-

Alarm Messages

tion
up position was functioning prop- sists, call Service.

not detected as erly.
completed. The
motor moves for
10 seconds and
the expected sen-
sor to stop the
motor was not
found.
1316 Pivot arm did not The move of the Either the motor The system performed an Emer-
move to the pivot arm to the was stalled or the gency stop. Perform a
down position. down position up sensor is not Recovery. If the problem per-
was not detected functioning prop- sists, call Service.
as completed. erly.
The motor
moves for 10 sec-
onds and the
expected sensor
to stop the
motor was not
found.
1317 Cuvette strip not After all devices Either the presence The system performed an Emer-
in shuttle after have suc- sensor is not func- gency stop. Perform a
pick up oper- cessfully per- tioning properly Recovery. If the problem per-
ation. formed their (ex. dirty) or a sists, call Service.
individual oper- cable has come
ations to pick unplugged.
up a cuvette, but
a cuvette was
not detected in
the shuttle.
1318 No cuvette strip A request was Either a cuvette is The system performed an Emer-
in shuttle to drop made to drop off really not present, gency stop. Perform a
off. a cuvette, but no the presence sensor Recovery. If the problem per-
cuvette is is not functioning sists, call Service.
detected in the properly (ex. dirty),
shuttle. or a cable has come
unplugged.
1319 Missing cuvette The shuttle is Either the operator The system performed an Emer-
strip in slot for ready to pick up did not place a gency stop. Perform a
pick up. a cuvette, but cuvette using diag- Recovery. If the problem per-


tion
there is no nostics, the Cuvette sists, call Service.

cuvette in the in slot sensor is not
slot. functioning, or the
scheduler timing is
not coordinated.
1320 Cuvette shuttle is The shuttle can- Either the presence The system performed an Emer-
full. not perform a sensor is not func- gency stop. Perform a
cuvette pick up tioning properly Recovery. If the problem per-
operation (ex. dirty), a cable sists, call Service.
because a has come
cuvette is unplugged, an oper-
already detected ator is attempting
in the shuttle. an invalid oper-
ation in diag-
nostics, or the
scheduler timing is
not correct.
1321 Cuvette not After all devices Either the presence The system performed an Emer-
released into slot. have suc- sensor is not func- gency stop. Perform a
cessfully per- tioning properly Recovery. If the problem per-
formed their (ex. dirty), the sists, call Service.
individual oper- gripper did not let
ations to drop go, the slot indexer
off a cuvette, did not engage the
but a cuvette cuvette strip, a
was still cable has come
detected in the unplugged, or the
shuttle. gripper did not
release the cuvette.
1323 Cuvette not The source posi- Either a scheduler The system performed an Emer-
present to pickup. tion for picking error or operator gency stop. Perform a
up a cuvette is error in diagnostics. Recovery. If the problem per-
empty. sists, call Service.
1324 Cuvette des- The destination Either a scheduler The system performed an Emer-
tination position position for plac- error or operator gency stop. Perform a
full. ing a cuvette is error in diagnostics. Recovery. If the problem per-
occupied. sists, call Service.
1325 Cannot pickup The requested Software logic The system performed an Emer-
from waste. cuvette pick up error. gency stop. Perform a
position is the Recovery. If the problem per-

Alarm Messages

tion
waste position sists, call Service.

which is not pos-
sible.
1326 Cannot drop off The requested Software logic The system performed an Emer-
at loader. drop off position error. gency stop. Perform a
is the loader Recovery. If the problem per-
position which sists, call Service.
is not possible.
1327 Cuvette load oper- Second cuvette Clip load time is The system performed an Emer-
ation too slow. move operation too slow. Oper- gency stop. Perform a
attempted prior ation did not com- Recovery. If the problem per-
to the load- plete prior to next sists, call Service.
er/indexer pre- request.
paring a new
cuvette strip.
1328 Invalid number of The number of The cuvette shuttle The system performed an Emer-
cuvette slots. cuvette slots sensors are dirty or gency stop. Perform a
detected is not a the configuration Recovery. If the problem per-
valid con- dip switch is set sists, call Service.
figuration (Base incorrectly.
vs. Aurora vs.
Mini).
1329 Cuvette slot The number of Either there are too The system performed an Emer-
found too early. required slots many mechanical gency stop. Perform a
was detected too slots or the sensor Recovery. If the problem per-
early in move has picked up sists, call Service.
distance. noise.
1330 Gripper back sen- During initial- Either a sensor fail- The system performed an Emer-
sor still active. ization (home), ure, cabling failure, gency stop. Perform a
the gripper or motor stall. Recovery. If the problem per-
attempts to sists, call Service.
move off the
back sensor, but
the sensor is still
detected. OR
Extend gripper
operation per-
formed, but the
back sensor is
still detected.


tion
1331 Gripper back sen- During initial- Either a sensor fail- The system performed an Emer-
sor not found. ization (home), ure, cabling failure, gency stop. Perform a
the gripper or motor stall. Recovery. If the problem per-
moves off the sists, call Service.
back sensor.
Once detected
to be off the sen-
sor, the motor
moves towards
the sensor to
make sure it can
be detected. If
the back sensor
is not detected
during this
search then the
alarm is gen-
erated.
1332 Gripper forward After the gripper Either a sensor fail- The system performed an Emer-
sensor still active. has completed a ure, cabling failure, gency stop. Perform a
retract move the or motor stall. Recovery. If the problem per-
forward sensor is sists, call Service.
still detected.
1333 Gripper forward Extend gripper Either a sensor fail- The system performed an Emer-
sensor not found. operation did ure, cabling failure, gency stop. Perform a
not detect the or motor stall. Recovery. If the problem per-
front sensor. sists, call Service.
1334 Cuvette waste The accumulator Tray mechanically The system performed an Emer-
tray did not is energized to stuck or solenoid gency stop. Perform a
dump. be in the down malfunction. Recovery. If the problem per-
position to drop sists, call Service.
the cuvettes on
the tray, but the
tray is still
detected in the
up position.
Allowed 250 ms
to move.
1335 Cuvette waste The accumulator Tray mechanically The system performed an Emer-
tray not ready to is deenergized stuck or solenoid gency stop. Perform a
receive cuvettes. malfunction. Recovery. If the problem per-

Alarm Messages

tion
to go to the up sists, call Service.

position to get
more cuvettes
onto the tray,
but the tray is
still detected in
the down
position.
Allowed 250 ms
to move.
1341 X Axis - Invalid X Axis - Invalid The universal arm The system performed an Emer-
Profile Parameter Profile Parameter controller reporting gency stop. Perform a
the alarm was sent Recovery. If the problem per-
a velocity profile sists, call Service.
parameter(s) for the
X axis motor that
exceeded max-
imum/minimum
criteria or was
incompatible with
other profile param-
eters.
1342 Y Axis - Invalid Y Axis - Invalid The universal arm The system performed an Emer-
Y axis motor that
exceeded max-
imum/minimum
criteria or was
incompatible with
eters.
1343 Z Axis - Invalid Z Axis - Invalid The universal arm The system performed an Emer-
Z axis motor that
exceeded max-


tion
imum/minimum
criteria or was
incompatible with
eters.
1344 X Axis - Speed X Axis - Speed The universal arm The system performed an Emer-
Exceeds Profile Exceeds Profile controller reporting gency stop. Perform a
Maximum Maximum the alarm was sent Recovery. If the problem per-
a command to sists, call Service.
move in the X axis
at a speed that
would exceed the
maximum stored in
the velocity profile.
1345 Y Axis - Speed Y Axis - Speed The universal arm The system performed an Emer-
move in the Y axis
at a speed that
would exceed the
maximum stored in
1346 Z Axis - Speed Z Axis - Speed The universal arm The system performed an Emer-
move in the Z axis
at a speed that
would exceed the
maximum stored in
1347 X Axis - Cannot X Axis - Cannot The universal arm The system performed an Emer-
Process Steps Process Steps controller reporting gency stop. Perform a
Required Required the alarm was sent Recovery. If the problem per-
a command to set sists, call Service.
the velocity profile

Alarm Messages

tion
for the X axis but

the parameters will
generate a profile
that will exceed
allocated memory.
1348 Y Axis - Cannot Y Axis - Cannot The universal arm The system performed an Emer-
for the Y axis but
the parameters will
generate a profile
that will exceed
allocated memory.
1349 Z Axis - Cannot Z Axis - Cannot The universal arm The system performed an Emer-
for the Z axis but
the parameters will
generate a profile
that will exceed
allocated memory.
1350 X Axis - Selected X Axis - The universal arm The system performed an Emer-
Profile Is Invalid Selected Profile controller reporting gency stop. Perform a
Is Invalid the alarm was sent Recovery. If the problem per-
select a particular
profile for the X
axis motor but the
profile does not
exist.


tion
1351 Y Axis - Selected Y Axis - The universal arm The system performed an Emer-
select a particular
profile for the Y
axis motor but the
profile does not
exist.
1352 Z Axis - Selected Z Axis - The universal arm The system performed an Emer-
select a particular
profile for the Z
axis motor but the
profile does not
exist.
1353 X Axis - Move X Axis - Move The universal arm The system performed an Emer-
Took Too Long Took Too Long controller reporting gency stop. Perform a
To Complete To Complete the alarm has Recovery. If the problem per-
detected that the an sists, call Service.
X axis move is tak-
ing longer than
expected to com-
plete.
Possible causes:
1. The universal
arm controller
receives a ver-
ification pulse from
the X axis motor
circuitry for each
step pulse. The con-
troller assumes that
an X axis move is
complete when the
number of ver-

Alarm Messages

tion
ification pulses
received is equal to
the step pulses
sent. Therefore a
malfunction in the
step clock/step ver-
ification circuitry
will cause this
alarm.
2. Software defect
especially TPU
loading com-
plications.
1354 Y Axis - Move Y Axis - Move The universal arm The system performed an Emer-
Took Too Long Took To Long controller reporting gency stop. Perform a
Y axis move is tak-
ing longer than
expected to com-
plete.
Possible causes:
1. The universal
arm controller
receives a ver-
the Y axis motor
circuitry for each
an Y axis move is
complete when the
number of ver-
ification pulses
the step pulses
sent. Therefore a
malfunction in the


tion

ification circuitry
will cause this
alarm.
2. Software defect
especially TPU
loading com-
plications.
1355 Z Axis - Move Z Axis - Move The universal arm The system performed an Emer-
Took Too Long Took Too Long controller reporting gency stop. Perform a
Z axis move is tak-
ing longer than
expected to com-
plete.
Possible causes:
1. The universal
arm controller
receives a ver-
the Z axis motor cir-
cuitry fro each step
pulse. The con-
n Z axis move is
complete when the
number of ver-
ification pulses
the step pulses
sent. Therefore a
malfunction in the
ification circuitry
will cause this
alarm.

Alarm Messages

tion
2. Software defect
especially TPU
loading com-
plications.
1356 X Axis - Move- X Axis - Move- The universal arm The system performed an Emer-
ment Generates ment Generates controller reporting gency stop. Perform a
Too Many Steps Too Many Steps the alarm was sent Recovery. If the problem per-
move the X axis
motor to a position
which would
require exceeding
the number of steps
that can be proc-
essed.
1357 Y Axis - Move- Y Axis - Move- The universal arm The system performed an Emer-
move the Y axis
motor to a position
which would
require exceeding
the number of steps
that can be proc-
essed.
1358 Z Axis - Move- Z Axis - Move- The universal arm The system performed an Emer-
move the Z axis
motor to a position
which would
require exceeding
the number of steps
that can be proc-
essed.
1359 X Axis - Invalid X Axis - Invalid The universal arm The system performed an Emer-
Limit State While Limit State control reporting gency stop. Perform a
Homing While Homing the alarm was Recovery. If the problem per-


tion
attempting to ini-
tialize the X axis
motor but encoun-
tered a limit sensor
that did not change
state as expected.
Could be caused
by slippage in the
X axis, software
defect, or mal-
functioning or mis-
placed limit
sensor(s).
1360 Y Axis - Invalid Y Axis - Invalid The universal arm The system performed an Emer-
attempting to ini- sists, call Service.
tialize the Y axis
motor but encoun-
that did not change
state as expected.
Could be caused
by slippage in the
Y axis, software
defect, or mal-
functioning or mis-
placed limit
sensor(s).
1361 Z Axis - Invalid Z Axis - Invalid The universal arm The system performed an Emer-
attempting to ini- sists, call Service.
tialize the Z axis
motor but encoun-
that did not change
state as expected.
Could be caused

Alarm Messages

tion
by slippage in the
Z axis, software
defect, or mal-
functioning or mis-
placed limit
sensor(s).
1362 X Axis - Limit X Axis - Limit The universal arm The system performed an Emer-
Detected During Detected During control reporting gency stop. Perform a
Move Move the alarm has Recovery. If the problem per-
detected that the X sists, call Service.
axis motor tripped
a travel limit sensor
during a move.
Could be caused
by:
1. slippage in the
X axis.
2. software defect
3. malfunctioning
or misplaced limit
sensor(s)
4. X axis Encoder
malfunction.
1363 Y Axis - Limit Y Axis - Limit The universal arm The system performed an Emer-
detected that the Y sists, call Service.
axis motor tripped
during a move.
Could be caused
by:
1. slippage in the
Y axis.


tion
2. software defect
3. malfunctioning
or misplaced limit
sensor(s)
4. Y axis Encoder
malfunction.
1364 Z Axis - Limit Z Axis - Limit The universal arm The system performed an Emer-
detected that the Z sists, call Service.
axis motor tripped
during a move.
Could be caused
by:
1. slippage in the
Z axis.
2. software defect
3. malfunctioning
or misplaced limit
sensor(s)
4. Z axis Encoder
malfunction.
1365 X Axis - Slippage X Axis - Slip- The universal arm The system performed an Emer-
Detected page Detected control reporting gency stop. Perform a
the alarm has Recovery. If the problem per-
detected that the X sists, call Service.
axis motor did not
reach the expected
position at the com-
pletion of a move.
Could be caused
by:

Alarm Messages

tion
1. Blockage or
restricted move-
ment in the X axis.
2. Faulty X axis
position encoder.
3. X axis velocity
profile parameters
are incompatible
with current sys-
tem.
1366 Y Axis - Slippage Y Axis - Slip- The universal arm The system performed an Emer-
axis motor did not
reach the expected
pletion of a move.
Could be caused
by:
1. Blockage or
restricted move-
ment in the Y axis.
2. Faulty Y axis
position encoder.
3. Y axis velocity
profile parameters
are incompatible
with current sys-
tem.
1367 Z Axis - Slippage Z Axis - Slip- The universal arm The system performed an Emer-
axis motor did not


tion
reach the expected

pletion of a move.
Could be caused
by:
1. Blockage or
restricted move-
ment in the Z axis.
2. Faulty Z axis
position encoder.
3. Z axis velocity
profile parameters
are incompatible
with current sys-
tem.
1368 X Axis - Cannot X Axis - Cannot The universal arm The system performed an Emer-
Store More Store More controller reporting gency stop. Perform a
Ramps Ramps the alarm ran out of Recovery. If the problem per-
memory allocated sists, call Service.
for storage of ramps
for the X axis
motor.
1369 Y Axis - Cannot Y Axis - Cannot The universal arm The system performed an Emer-
for the Y axis
motor.
1370 Z Axis - Cannot Z Axis - Cannot The universal arm The system performed an Emer-
for the Z axis
motor.

Alarm Messages

tion
1371 X Axis - Motor X Axis - Motor The universal arm The system performed an Emer-
Stalled Stalled controller reporting gency stop. Perform a
the alarm is report- Recovery. If the problem per-
ing that periodic sists, call Service.
readings of the X
axis motor position
encoder indicate
that the current
move is being
restricted or
blocked.
Could be caused
by:
1. Blockage or
restricted move-
ment in the X axis.
2. Faulty X axis
position encoder.
3. X axis velocity
profile parameters
are incompatible
with current sys-
tem.
1372 Y Axis - Motor Y Axis - Motor The universal arm The system performed an Emer-
readings of the Y
axis motor position
encoder indicate
that the current
move is being
restricted or
blocked.
Could be caused
by:


tion
1. Blockage or
restricted move-
ment in the Y axis.
2. Faulty Y axis
position encoder.
3. Y axis velocity
profile parameters
are incompatible
with current sys-
tem.
1373 Z Axis - Motor Z Axis - Motor The universal arm The system performed an Emer-
readings of the Z
axis motor position
encoder indicate
that the current
move is being
restricted or
blocked.
Could be caused
by:
1. Blockage or
restricted move-
ment in the Z axis.
2. Faulty Z axis
position encoder.
3. Z axis velocity
profile parameters
are incompatible
with current sys-
tem.
1374 X Axis - Oper- X Axis - Oper- The universal arm The system performed an Emer-
ation Timeout ation Timeout gency stop. Perform a

Alarm Messages

tion
controller reporting sists, call Service.

the alarm has
detected that the X
axis motor is taking
too long to com-
plete a move.
Possible causes:
1. The universal
arm controller
receives a ver-
the X axis motor
circuitry fro each
an X axis move is
complete when the
number of ver-
ification pulses
the step pulses
sent. Therefore a
malfunction in the
ification circuitry
will cause this
alarm.
2. Software defect
especially TPU
loading com-
plications.
1375 Y Axis - Oper- Y Axis - Oper- The universal arm The system performed an Emer-
ation Timeout ation Timeout controller reporting gency stop. Perform a


tion
too long to com-

plete a move.
Possible causes:
1. The universal
arm controller
receives a ver-
the Y axis motor
circuitry fro each
an Y axis move is
complete when the
number of ver-
ification pulses
the step pulses
sent. Therefore a
malfunction in the
ification circuitry
will cause this
alarm.
2. Software defect
especially TPU
loading com-
plications.
1376 Z Axis - Oper- Z Axis - Oper- The universal arm The system performed an Emer-
ation Timeout ation Timeout controller reporting gency stop. Perform a
too long to com-
plete a move.

Alarm Messages

tion
Possible causes:
1. The universal
arm controller
receives a ver-
the Z axis motor cir-
cuitry fro each step
pulse. The con-
n Z axis move is
complete when the
number of ver-
ification pulses
the step pulses
sent. Therefore a
malfunction in the
ification circuitry
will cause this
alarm.
2. Software defect
especially TPU
loading com-
plications.
1377 X Axis - Oper- X Axis - Oper- This is an internal The system performed an Emer-
ation Failed ation Failed software error. gency stop. Perform a
Cause is always sists, call Service.
software defect.
Incorrect message
was placed on a
queue.
1378 Y Axis - Oper- Y Axis - Oper- This is an internal The system performed an Emer-


tion

software defect.
Incorrect message
was placed on a
queue.
1379 Z Axis - Oper- Z Axis - Oper- This is an internal The system performed an Emer-
software defect.
Incorrect message
was placed on a
queue.
1380 Tube Release Pro- Tube Release The universal arm The system performed an Emer-
cedure Failed Procedure Failed controller reporting gency stop. Perform a
detected during sists, call Service.
initialization the
tube release oper-
ation failed.
The tube release

operation is fairly
complicated, but in
general it attempts
to extract the
piercer from a
capped tube during
initialization by
locking the foot
and moving the
piercer up until the

Alarm Messages

tion
cap detect is no
longer active.
This is only appli-

cable to CTS instru-
ments.
The failure can

have many causes:
1. Faulty cap,
limit, piercer posi-
tion, or piercer
latch sensors.
2. restricted or
blocked movement
in the Z axis.
3. Piercer latch
solenoid.
4. Excessive fric-
tion between
piercer latch and
probe.
5. Excessive force
required to extract
the piercer from the
cap.
6. Software defect.
1381 Sensor Or Motor Sensor Or Motor The universal arm The system performed an Emer-
Failure Caused Failure Caused controller reporting gency stop. Perform a
Latch Offset Latch Offset the alarm has Recovery. If the problem per-
Measurement To Measurement To detected that the sists, call Service.
Fail Fail


tion
latch offset meas-

urement operation
failed.
This is only appli-

cable to CTS instru-
ments.
The failure can

have many causes:
1. Faulty cap,
limit, piercer posi-
tion, or piercer
latch sensors.
2. Restricted or
blocked movement
in the Z axis.
3. Piercer latch
solenoid.
4. Excessive fric-
tion between
piercer latch and
probe.
5. Software defect.
1382 LLD Hardware LLD Hardware The universal arm The system performed an Emer-
Failure Failure controller reporting gency stop. Perform a
the arm has Recovery. If the problem per-
detected that the sists, call Service.
LLD circuitry is
not interrupting the
processor at the
required rate.
1383 Piercer Was Not Piercer Was Not The universal arm The system performed an Emer-
In The Expected In The Expected controller reporting gency stop. Perform a
State State the alarm was sent Recovery. If the problem per-
a command to ver- sists, call Service.
ify that the piercer

Alarm Messages

tion
was in a particular
state (CTS or Sam-
ple). The ver-
ification failed.
i.e. There is a mis-

match between the
state that the
Master SW expects
the Piercer to be in
and the state that
the universal arm
controller thinks
the piercer is in.
1384 Z Axis - Power Z Axis - Power The universal arm The system performed an Emer-
DAC failed DAC failed controller reporting gency stop. Perform a
detected that DAC sists, call Service.
controlling the
amount of power to
the Z axis motor is
not performing
within tolerances.
1385 Syringe Is Syringe Is The universal arm The system performed an Emer-
Always Busy Always Busy controller reporting gency stop. Perform a
the alarm is waiting Recovery. If the problem per-
for the syringe to sists, call Service.
complete an oper-
ation but it is tak-
ing too long.
1387 Syringe Took Syringe Took The universal arm The system performed an Emer-
Too Long To Too Long To controller reporting gency stop. Perform a
Respond Respond the alarm is waiting Recovery. If the problem per-
for the syringe to sists, call Service.
respond to a pre-
vious command but
it took too long.
1388 Syringe Could Syringe Could The universal arm The system performed an Emer-
Not Be Initialized Not Be Initial- controller reporting gency stop. Perform a
ized the alarm could not Recovery. If the problem per-
initialize the arms sists, call Service.


tion
syringe pump.
1389 Syringe Does Not Syringe Does The universal arm The system performed an Emer-
Understand The Not Understand controller reporting gency stop. Perform a
Command The Command the alarm received Recovery. If the problem per-
an error message sists, call Service.
from the arms
syringe indicating
that the syringe did
not understand the
last command sent
to it.
1390 Syringe Com- Syringe Com- The universal arm The system performed an Emer-
mand Parameter Is mand Parameter controller reporting gency stop. Perform a
Invalid Is Invalid the alarm received Recovery. If the problem per-
from the arms
syringe indicating
that the last com-
mand sent to it con-
tained an invalid
parameter.
1391 Syringe Must Be Syringe Must Be The universal arm The system performed an Emer-
Initialized Initialized controller reporting gency stop. Perform a
the alarm received Recovery. If the problem per-
from the arms
syringe indicating
that it must be
initialized before
any further com-
mands can be per-
formed.
1392 Syringe Plunger Syringe Plunger The universal arm The system performed an Emer-
Is Overloaded Is Overloaded controller reporting gency stop. Perform a
from the arms
syringe indicating
that the plunger is
overloaded.

Alarm Messages

tion
1393 Syringe Valve Is Syringe Valve Is The universal arm The system performed an Emer-
Overloaded Overloaded controller reporting gency stop. Perform a
from the arms
syringe indicating
that the valve is
overloaded.
1394 Syringe Move Is Syringe Move Is The universal arm The system performed an Emer-
Not Permitted Not Permitted controller reporting gency stop. Perform a
from the arms
syringe indicating
that a plunger
move is not per-
mitted. When the
valve is in bypass
or throughput posi-
tion plunger move-
ment commands are
not allowed.
1395 Syringe Error Syringe Error The universal arm The system performed an Emer-
With Unknown With Unknown controller reporting gency stop. Perform a
Source Source the alarm received Recovery. If the problem per-
from the syringe
but it is not a rec-
ognized published
error.
1396 Error Com- Error Com- The universal arm The system performed an Emer-
municating With municating controller reporting gency stop. Perform a
The Syringe With The the alarm is indi- Recovery. If the problem per-
Syringe cating that either sists, call Service.
1. The buffer used

for receiving serial
data from the
syringe has over-
flowed.


tion
2. The control sig-

nals used for coor-
dinating serial data
transmission to the
syringe are not in
the correct state.
1397 Syringe Hardware Syringe Hard- Not used. The system performed an Emer-
Malfunction ware Mal- gency stop. Perform a
function Recovery. If the problem per-
1414 CTS piercer lock CTS piercer lock The AM has The system performed an Emer-
not locked not locked detected that the gency stop. Perform a
piercer latch is not Recovery. If the problem per-
in one of it's detent sists, call Service.
positions.
1415 CTS probe mode CTS probe mode The AM attempted The system performed an Emer-
switch failure switch failure to set the CTS gency stop. Perform a
mode (sample or Recovery. If the problem per-
CTS) but after ver- sists, call Service.
ifying determined
that the piercer was
not in the expected
mode.
Possible causes:
1. CTS spring ten-

sion too light.
2. Faulty CTS posi-

tion,
or latch sensor
3. Faulty latch sole-

noid or circuitry.
1416 Cannot switch The CTS hard- The sensor was not Perform a recovery. If the prob-
CTS between ware used to seen after per- lem persists, call service.
piercing and sam- change the forming the CTS

Alarm Messages

tion
ple mode. probe between mode switch oper-

piercing mode ation. Failure could
and sample be sensor, spring,
mode failed to solenoid, or soft-
switch. ware.
1417 Location unreach- Vial Location Invalid arm homing Perform Coordinates Adjust-
able by Probe Unreachable position or coor- ment. If the problem persists,
<Probe>: track # dinate adjustment call service.
<Rack>,position failure.
<Position>.
1418 Location unreach- Cuvette Loca- Invalid arm homing Perform Coordinates Adjust-
able by Probe tion Unreach- position or coor- ment. If the problem persists,
<Probe>: cuvette able dinate adjustment call service.
<Cuvette Slot failure.
ID>, well <well
position>.
1439 <Probe> probe Cannot com- Cannot com- The system performed an Emer-
communications municate with municate with the gency stop. Perform a
failure. the probe. probe. Either com- Recovery. If the problem per-
munications cable sists, call Service.
is not in place or
probe computer
board has mal-
functioned.
2010 <Cover ID> Safety cover The cover was left Close the cover. The system
open. detected open open. performed an Emergency stop:
not in diag- once the cover is closed, per-
nostics. form a Recovery.
2080 Unrecoverable The actual Internal scheduling The system performed an Emer-
scheduling time execution did conflict. gency stop. Perform a
violation. not meet a crit- Recovery.
ical scheduling
time. The job If the problem persists, call
failed and it is Service.
not possible to
recover
2081 Rack in <Track A rack already Rack accidentally Perform Recovery operation.
ID> slot inserted dislodged.
unplugged. becomes


tion
unplugged with
the reader not in
front of the rack.
2082 ORU Air Cal- Air Calibration The Optical Read- Go to Diagnostics and run the
ibration data not data for the spec- ing Unit air cal- Air Calibration procedure.
available for ified ORU are ibration procedure
ORU <ORU ID>. not available. has never been
executed for this
The instrument ORU.
is not able to
perform air read-
ing drift checks.
2084 An invalid blank- An invalid ORU The user has Go to Diagnostics and run
ing value has blanking value accepted an out of ORU Blanking procedure
been accepted for has been range blanking again.
ORU <ORU ID> accepted by the value.
(Value = user. The ORU
<VALUE>). The will be auto-
ORU will be automatically dis-
matically disabled.
abled.
2085 ORU Factor Dil- Factor Diluent The Optical Read- Go to Diagnostics and run the
uent Calibration Calibration data ing Unit Factor Dil- Stored Factor Diluent Cal-
data not available for the specified uent Calibration ibration procedure.
for ORU <ORU ORU are not procedure has never
ID>. available. been executed for
this ORU.
The instrument
is not able to cal-
culate absolute
absorbance.
2087 Maximum There is not There is not The tests exceeding the max-
number of tests more memory in enough memory for imum number per run are not
allowed per run the AM for proc- processing more performed. Run canceled tests
exceeded. essing more tests. within another analytical ses-
tests. sion.
2091 CTS Filter miss- CTS Filter miss- The CTS filter was Please install a clean CTS
ing. ing detected as missing. filter.

Alarm Messages

tion
2092 Air pressure sen- Air pressure sen- The air pressure sen- Call Service.
sor not operating sor not oper- sor is not respond-
correctly. ating correctly. ing. Air is not
being discharged to
CTS piercer cor-
rectly due to
obstructed, dam-
aged or dis-
connected air
pressure Valves.
2093 Not enough free System detected The system Shutdown the CM application
disk space. not enough free detected less than and free some disk space. If
disk space to 100 megabytes of this problem persists, contact
run the appli- free space in the your System Administrator.
cation disk where the
ACL TOP appli-
cation is installed.
2094 The default file If the default file Wrong file path Verify the file path spec-
path for the log path does not specification or ification: if it is wrong, correct
files does not exist, the system insufficient rights it and retry. If this is not the
exist and cannot tries to auto- to write to the case, verify he has the appro-
be created. matically create drive or HW/SW priate write permissions or call
it. The operation failure of the drive. service to repair the drive.
could fail for dif-
ferent causes:
- wrong file
path spec-
ification
- insufficient
rights to write to
the drive
- HW/SW fail-
ure of the drive


tion
3023 Duplicated Rack Two different Two racks with the Remove one of the two racks
ID, Rack ID Racks have been same ID have been with the duplicated ID.
<Rack ID>. identified with loaded on-board.
the same Rack
ID.
3211 Auto Run failed. Auto Run could Possible causes are: The system looks for an oppor-
not be started tunity to auto start every 1
and the instru- - CTS Filter was minute. Certain conditions
ment is Ready. not detected (for might change without oper-
CTS configuration ator's intervention.
only).
Identify the cause among the
- Enhanced clean following and resolve if nec-
required. essary:
- Temperatures are - CTS Filter missing: install a

out of range. new filter (Maintenance activ-
ity).
- Enhanced Clean required:

perform Enhanced Clean for
all probes (Maintenance activ-
ity).
- Temperatures are out of

range: wait until the tem-
peratures stabilize (depending
from the system and ambient
conditions, this might take
more than 30 minutes); if they
do not stabilize, call Service.
3213 The system Software version CM, AM Master Call Service.

detected a soft- is for exper- software or con-
ware version imental use troller software is
designed for only. A con- not a system release
experimental use. troller, master, version.
IM or CM is
compiled in
debug or the ver-
sion name is
experimental.
CM is a Demo

Alarm Messages

tion
installation.
4004 Invalid barcode Barcode size Barcode label Use valid barcode labels.
size. bigger than the bigger that 16 char-
maximum size acters.
of sample Id (16
characters)
4005 Rack rejected. The bar code Rack barcode read- Reinsert the rack. If the prob-
label read is ing error, missing lem persists, use another rack.
invalid. barcode labels or
rack entered too
quickly.
4006 CTS rack CTS rack CTS Rack inserted Enable cap piercing and rein-
rejected. rejected. when cap piercing sert the rack or use a non-CTS
is not enabled or rack.
CTS arm not
installed.
4007 Cap not detected Cap not The CTS probe If a sample cup is loaded in
for sample in rack detected by the descended down to that position, remove it from
<Rack ID>, posi- piercer the maximum cap the CTS rack and load it on a
tion <position search depth but open-tube sample rack. Only
#>, track <Track could not detect capped sample tubes should be
ID>. the presence of a loaded on CTS racks. Sample
cap for the sample cups and uncapped sample con-
in the specified tainers should be loaded on
position. Possible open-tube sample racks.
cause is the pres-
ence of a sample
cup or a similar
low-height sample
container.
4015 Rack button iden- The rack button Rack position key- Call Service.
tification failure. pressed is not a pad malfunction.
valid code.
4020 Barcode reader Cannot com- Cable dis- Call Service.

communication municate with connected. Barcode
failure. the bar code reader malfunction.
reader.
Rack controller or
Reader Traveling
board malfunction.


tion
4054 The analyzer is The analyzer is The analyzer is Enable again the piercing
unable to process unable to proc- able to process the mode when the instrument is
the request to ena- ess the request request only if the the proper status.
ble CTS piercing to enable CTS instrument status is
probe mode. piercing probe POWER UP,
mode. READY or DIAG-
NOSTICS and the
sample probe is not
performing any
diagnostics activity
and there is no CTS
rack inserted.
4055 The analyzer is The analyzer is The analyzer is Disable again the piercing
unable to process unable to proc- able to process the mode when the instrument is
the request to dis- ess the request request only if the the proper status.
able CTS piercing to disable CTS instrument status is
probe mode. piercing probe POWER UP,
mode. READY or DIAG-
NOSTICS and the
sample probe is not
performing any
diagnostics activ-
ity.
4057 CM in use is from The system A database has The use of this CM will
a different ACL detected the been restored from require service intervention.
TOP model. instrument a different model or Please call service.
model is dif- the application is
ferent than dur- connected to a dif-
ing last ferent instrument
connection. This model.
will happened
between Micro-
TOP, MiniTop
and TOP models
(base TOP, CTS,
LAS).
4058 Unable to create Unable to create Unable to create Please verify that there is
raw data report a raw data report raw data report file. enough disk space on the sys-
<path&filename>. file. tem. Please verify that the raw
data report path is legitimate
and you have write privileges

Alarm Messages

tion
in the log folder.


Alarm Messages
External Communications Alarms

External Communications Alarms – Warnings and Errors
Code Message Alarm Description Operator Action Alarm
Category
0059 Interface Module IM Upgrade Failed The application must be LAS

upgrade failed. re-started in order to
execute the IM upgrade
process again. If the prob-
lem persist, call Service.
0060 Incompatible IM soft- Incompatible IM software version. Call Service LAS

ware version.
3022 The LIS host has The LIS host has requested a test with LIS
requested a test with invalid demographic data like a birthdate
invalid demographic greater than current date.
data.
3031 Incorrect Instrument The ACL-TOP instrument has received a Check the Instrument ID LIS
ID (<Instrument message from the LIS host with an Instru- in Host communications
ID>) message ment ID and/or Host ID, which do not configuration, and mod-
received from LIS match the configured ones. ify its value if required.
host. Otherwise, check LIS
host operation.
3032 Message received The ACL-TOP instrument has received a Check the Host ID in LIS
with incorrect Host message from the LIS host with an Instru- Host communications
ID (<Host ID>). ment ID and/or Host ID, which do not configuration, and mod-
match the configured ones. ify its value if required.
Otherwise, check LIS
host operation.
3033 Invalid Test Code The LIS host has requested an unknown Check tests currently LIS
received from host test. available or contact the
host administrator.
(LIS # <LIS #>).
3034 Test orders down- The user requests a manual job orders Report the error to the LIS
loading from host download that the ACL-TOP instrument host administrator.
not performed. cannot accomplish. In the same way, the
ACL-TOP instrument tries to perform an
automatic job orders downloading, and the
result is the same.
3035 Test results upload- The user requests a manual test results Report the error to the LIS
ing to LIS host not upload that the ACL-TOP instrument can- host administrator.
performed. not accomplish. In the same way, the ACL-
TOP instrument tries to perform an auto-


Category
matic test results uploading, and the result

is the same.
3036 Invalid Test Request The LIS host has requested a test that is Update Test Definition LIS
received from host either disabled or inconsistent. and/or Enable it.
(LIS # <LIS #>).
3037 Duplicated Test The LIS host has requested a test that is LIS
Order for <Sam- already present in the instrument.
pleId> received from
host (LIS # <LIS
#>).
3038 Invalid Instrument The LIS host has requested a test for sam- Report the error to the LIS
Sample ID <Instru- ple whose Instrument Sample ID is host administrator.
ment Sample ID> unknown.
received from host.
3039 LIS request not LIS host sent a request that is not imple- Report the error to the LIS
allowed. mented for TOP. host administrator.
3040 Invalid message for- The format of the message or fields con- Report the error to the LIS
mat received from tained in it are not compliant with the host administrator.
LIS host. TOP specifications.
3041 Host Query not per- The ACL-TOP instrument tries to perform Report the error to the LIS
formed. an automatic host query without suc- host administrator.
ceeding.
3042 Communications Communications between the instrument Report the error to the LIS
between the instru- and the LIS have been lost. host administrator.
ment and the LIS
have been lost.
3043 Test Order can- The ACL-TOP could not process a test Report the error to the LIS
cellation not per- order cancellation coming from the LIS host administrator.
formed (LIS # <LIS host.
#>).
3044 Creation of the LIS The ACL-TOP could not create a channel Report the error to the LIS
communication chan- for communicating with the LIS Host. host administrator.
nel failed.

Alarm Messages

Category
3045 Current LIS channel The current channel configuration defined Report the error to the LIS
configuration is not through the control panel is not supported. host administrator.
supported.
3200 Storage of messages The UDC storage is almost full of mes- Check communication LIS
sent to LIS <%> sages waiting to be sent to LIS. status in both ends. If
full. communication cannot
be restored, disable them
and call service.
3201 Storage of messages The UDC storage is almost full of mes- Check communication LIS
sent to LIS over- sages waiting to be sent to LIS. No more status in both ends. If
loaded. New messages are accepted. communication cannot
uploaded messages be restored, disable them
will be rejected. and call service.
3202 Upload message was UDC Rejected Uploaded Message Check communication LIS
rejected and there- status in both ends. If
fore not sent to LIS. communication cannot
and call service.
4059 LAS Interface Man- LAS Interface Manager (IM) com- Check LAS Interface LAS
ager (IM) communications error. Manager (IM) con-
munications error. nection, if the problem
persists call Service. Dur-
ing IM Upgrade process,
ignore this alarm.
10000 LAS Track com- LAS Track communications error. Check LAS Track/IM LAS
munications error. connection. If the prob-
lem persists, call Service.
10002 LAS Track Unavail- LAS Track Unavailable. Check LAS Track. If the LAS
able. problem persists call Serv-
ice of Track Vendor.
10003 LAS Sample <Sam- LAS Track has provided sample data with LAS
ple ID> rejected. inconsistencies.
10004 LAS Sample <Sam- Capped Tube provided by the LAS Track. LAS
ple ID> rejected.
10005 Reset Queue LAS Track has requested to reset the queue Check Analyzer. LAS
Request denied. but the instrument does not let it do that.
Allow to clear the Check LAS probe to


Category
physical queue is ensure the LAS probe is

unsafe. not inside the sample
tube. If problem persists,
call Service.
10007 LAS Sample <Sam- LAS Sample was intended to be provided LAS
ple ID> rejected. while a Reset Queue was in progress.
10006 LAS Sample <Sam- The instrument rejects the LAS Sample If problem persists, call LAS
ple ID> cannot be because it is not ready for sampling. Service.
processed at this
time.
10008 LAS Sample <Sam- Sample not expected at Aspiration Point. LAS
ple ID> not
expected at Aspi-
ration Point. This
sample shall not be
processed.
10009 LAS Sample <Sam- Sample not expected at Aspiration Point. LAS
ple ID> order dif-
ferent than the
expected at Aspi-
ration Point. This
sample shall be proc-
essed.
10010 LAS Sample <Sam- Sample Not processed due to the jobs are LAS
ple ID> not proc- not available.
essed.
10011 LAS Sample <Sam- Sample Not processed due to the Sample LAS
ple ID> not proc- Tube Queue is empty
essed.
10012 LAS Sample <Sam- Sample Not processed due to a not fluid LAS
ple ID> not proc- detected.
essed.
10013 LAS Sample <Sam- Sample Not processed due to an Insuf- LAS
ple ID> not proc- ficient Volume.
essed.
10014 LAS Sample <Sam- Sample Not Processed due to a LAS Arm LAS
ple ID> not proc- Failure.

Alarm Messages

Category
essed.
10015 LAS Sample <Sam- Sample ID mismatching when releasing the LAS
ple ID> not proc- Sample Tube.
essed. ID before
aspiration: <Sample
ID>. ID after aspi-
ration: <Sample
ID>.
10016 LAS Track request LAS Track sent a request that is not imple- Report the error to the LAS
not supported. mented/supported for TOP. administrator. If problem
persists, call Service.
10017 Invalid Format Mes- The format of the message or fields con- Report the error to the LAS
sage. tained in it are not compliant with the administrator.
TOP specifications.
The Operating System
Event Log can be
reviewed for further infor-
mation about the field
that was not properly for-
matted.
10018 Creation of the LAS The ACL-TOP could not create a channel Report the error to the LAS
Track com- for communicating with the LAS Track. administrator.
munication channel
failed.
10019 Creation of the LAS The current channel configuration defined Report the error to the LAS
Track com- through the control panel is not supported. administrator
munication channel
failed.
10020 Storage of messages The Synapse storage is almost full of mes- Check communication LAS
sent to the LAS sages waiting to be sent to the LAS Track. status in both ends. If
Track <%> full. communication cannot
and call service.
10021 Storage of messages The Synapse storage is almost full of mes- Check communication LAS
sent to the LAS sages waiting to be sent to the LAS Track. status in both ends. If
Track overloaded. No more messages are accepted. communication cannot
New uploaded mes- be restored, disable them
sages will be and call service.
rejected.


Category
10022 LAS Track com- Message not delivered to the LAS Track. Check communication LAS
munications error. status in both ends. If
communication cannot
and call service.
10023 LAS Sample <Sam- Tube Type provided by the LAS Track not LAS
ple ID> rejected. supported.
10024 LAS Sample <Sam- Sample Not Processed due to an Instrument LAS
ple ID> not proc- Hardware Error.
essed.
10026 IM software error. IM Software internal exception. Report the error to the LAS
administrator.
10027 LAS Track com- Message not responded by the LAS Track. Check communication LAS
munications error. status in both ends. If
communication cannot
and call service.
10028 LAS Sample <Sam- Sample ID not supported. LAS

ple ID> not sup-
ported. This tube
shall be released.
10029 LAS Sample <Sam- Sample Not Processed due to LAS Sample Resend the tube to the LAS
ple ID> not proc- Aspiration timeout. track in case the tube
essed. needs to be processed.

Alarm Messages
Setup Alarms
Setup Alarms – Warnings and Errors
Code Message Alarm Description
3060 Test Definition <test name> has been added. A new Test Definition has been added.
3061 Test Definition <test name> has been mod- An existing Test Definition has been modified.
ified.
3062 Test Definition <test name> has been A Test Definition has been deleted.
deleted.
3063 Material Definition <material name> has A new Material Definition has been added.
been added.
3064 Material Definition <material name> has A Material Definition has been deleted.
been deleted.
3065 Material Definition <material name> mod- The Active Lot - ISI value of a Material Definition
ified: ISI value (active Lot). has been changed.
3066 Material Definition <material name> mod- The stability configuration of a Material Def-
ified: on-board stability. inition has been changed.
3067 Material Definition <material name> mod- The active Lot - assigned value of a Material Def-
ified: assigned value for Test <test name> inition & Test Definition has been changed.
(active Lot).
3068 Material Definition <material name> mod- The active Lot - expiration date cfg. of a Material
ified: expiration date (active Lot). Definition has been changed.
3069 Material Definition <material name> mod- The Lot management cfg. of a Material Definition
ified: Lot management. has been changed.
3070 Material Definition <material name> mod- The active Lot - Lot Number of a Material Def-
ified: Lot Number (active Lot). inition has been changed.
3071 Material Definition <material name> mod- The alternative Lot cfg. of a Material Definition
ified: Alternative Lot cfg. has been changed.
3072 Material Definition <material name> generic An existing Material Definition has been mod-
change. ified.
3073 System Definitions: generic change. Global change in System Definitions.
3074 System Definitions: Barcode parameters mod- System Definitions, Barcode parameters changed.
ified.


3075 System Definitions: LIS parameters modified. System Definitions, LIS parameters changed.
3076 QC Definition <Test name> - <Material A new QC Definition has been added.
name> has been added.
3077 QC Definition <Test name> - <Material A QC Definition has been deleted.

name> has been deleted.
3078 QC Definition <Test name> - <Material The Target Mean of a QC Definition has been
name> modified: Target Mean. changed.
3079 QC Definition <Test name> - <Material The Target SD of a QC Definition has been
name> modified: Target SD. changed.
3080 QC Definition <Test name> - <Material The Patient Flags of a QC Definition have been
name> modified: Patient Flags. changed.
3081 QC Definition <Test name> - <Material The Rules cfg. of a QC Definition have been
name> modified: Rules cfg. changed.
3082 QC Definition <Test name> - <Material The Frequency cfg. of a QC Definition has been
name> modified: Frequency cfg. changed.
3083 QC Definition <Test name> - <Material The Unit of a QC Definition has been changed.
name> modified: QC Unit.
3100 Software access permissions have been mod- The user changed some access levels in the Soft-
ified. ware access screen.
3101 User Definition <User Name> has been A new User Definition has been added
added.
3102 User Definition <User Name> has been An existing User Definition has been deleted.
deleted.
3103 User Definition <User Name> has been mod- An existing User Definition has been modified.
ified.
3104 User Definition <User Name> modified: The security Level of an existing User Definition
Security Level. has been changed.
3105 User Definition <User Name> locked by the The user intended to log in with erroneous pass-
system. word 3 consecutive times, so the system has
locked this user.

Alarm Messages

3110 Reflex Rule <Reflex Rule Name> has been A new Reflex Rule has been added.
added.
3111 Reflex Rule <Reflex Rule Name> has been An existing Reflex Rule has been deleted.
deleted.
3112 Reflex Rule <Reflex Rule Name> has been Reflex Rule has been modified.
modified.
3120 Auto-Validation Rules have been modified. Auto-Validation Rules have been modified.
3130 Sender Definition <Sender Code> has been A new Sender Definition has been added.
added.
3131 Sender Definition <Sender Code> has been An existing Sender Definition has been deleted.
deleted.
3132 Sender Definition <Sender Code> has been An existing Sender Definition has been modified.
modified.
3140 Test Profile <Test Profile Name> has been A new Test Profile Definition has been added.
added.
3141 Test Profile <Test Profile Name> has been A Test Profile Definition has been deleted.
deleted.
3142 Test Profile <Test Profile Name> has been A Test Profile Definition has been modified.
modified.
3145 QC Profile <QC Profile Name> has been A new QC Profile Definition has been added.
added.
3146 QC Profile <QC Profile Name> has been A QC Profile Definition has been deleted.
deleted.
3147 QC Profile <QC Profile Name> has been A QC Definition has been modified.
modified.
3161 Test Definition <source test Name> has been A Test Definition has been promoted.
promoted to <target test Name>.
3164 Vial Properties <Vial Type Name> <Vial AVial Properties has been added by the user.
Properties Revision> has been added.
3165 Vial Properties <Vial Type Name> <Vial AVial Properties has been deleted by the user.
Properties Revision> has been updated.
3166 Vial Properties <Vial Type Name> <Vial AVial Properties has been deleted by the user.


Properties Revision> has been deleted.
3167 Vial Set <Vial Set Name> has been added. AVial Set has been added by the user.
3168 Vial Set <Vial Set Name> has been updated. AVial Set has been deleted by the user.
3169 Vial Set <Vial Set Name> has been deleted. AVial Set has been deleted by the user.
3180 LAS parameters modified. LAS Definitions parameters changed.
3181 IM parameters modified. IM parameters changed.
3186 Imported Params Report files deleted. Ana- Files to generate Imported Params report have been
lytical Version in files is different than cur- deleted.
rent one.
4060 Test counter statistics have been reset. User reset the test counter statistics
4061 A new software version has been created A new system software version has been detected.
with following label: <Data Dictionary-SW
Version>.
4062 A new hardware event has been created with A new Hardware event has been added by the
following label: <Data Dictionary-HW user.
Event>.

Alarm Messages
Other Alarms
Other Alarms
Category
3106 Successful log in User was recognized and could log into Others
by user: <User>. the system.
3107 Unsuccessful log User could not be recognized and could Others
in by user: not log into the system.
<User>.
3108 Logout by user: User logged out from the system. Others
<User>.
3109 The user modified The user modified patient demographic Others
patient dem- information.
ographics for sam-
ple <SampleId>.
4063 Description: User entered a manual alarm. Others
<Description>
Functional Area:
<Functional
Area>
5090 (Prep) Material dis- AM reported a material dispense error. SW

pense error An unexpected material dispense error
was detected by the AM software. Not
expected behavior.
5100 Measured result The result unit is the measured result SW

failed and DR has been unable to compute it
5568 Calibration and Calibration transformations do not Calibration X or Y trans- SW

parallelism trans- match parallelism transformations. formations do not match.
formations do not Calibration may require
match recalculation.
XXXXX <Restricted> This message displays instead of patient Others

information when a non-authorized user
is logged on.

Popup and Message Windows

In addition to the alarms displayed in the alarms areas, certain warnings and errors will be displayed as pop
up or message windows to warn the operator or to prompt for action. For the LIS, warnings and errors may
also be displayed on the LIS host.
Popup and Message Windows – Warnings and Errors

Message Alarm Description Operator Action
Test definition error: empty test Test definitions: the test name is not
name. specified.
Test definition error: empty test Test definitions: the test code is not
code. specified.
Test definition error: unspecified Test definitions: the test number is not
test number specified.
Test definitions: test number is Test definition: test number is outside

outside the IL tests numbers the IL tests numbers range.
range.
Test definition error: duplicated Test definitions: the test code is already
test code. used in another TD.
Test definition error: duplicated Test definitions: the test number is

test number. already used in another TD.
Test definition error: duplicated Test definitions: the test LIS number is
LIS number. already used for another TD.
Test definition error: Duplicated Test definitions: the extended test mode
extended LIS number. LIS number is already used for another
TD.
Test definition error: duplicated Test definitions: the parallelism test LIS
parallelism LIS number. number is already used for another TD.
Test definition error: duplicated Test definitions: the alternative pre-

alternative prediluted LIS number. diluted test LIS number is already used
for another TD.
Test definition error: alternative Test definitions: alternative predilution

predilution cannot be disabled. test mode is referenced in reflex, pro-
Alternative predilution mode is files or test programming window.
referenced in test profiles, reflex,
test programming window or sam-
ple list.
Test definition error: extended can- Test definitions: extended test mode is
not be disabled. Extended mode is referenced in reflex, profiles or test pro-

Alarm Messages

referenced in test profiles, reflex, gramming window.

test programming window or sam-
ple list.
Test definition error: parallelism Test definitions: parallelism test mode

cannot be disabled. Parallelism is referenced in reflex, profiles or test
mode is referenced in test profiles, programming window.
reflex, test programming window
or sample list.
Test definition error: calibration Test definitions: calibration is ref-

cannot be disabled. Calibration is erenced in an imported calibration.
referenced in an imported cal-
ibration.
The test cannot be saved. Some of Test definitions: result unit referenced
the test units that have been in a QC definition cannot be removed.
removed are referenced in one or
more of the QC definitions.
the test units that have been in reflex rule cannot be removed.
removed are referenced in one or
more of the reflex rules.
the test units that have been in sample list cannot be removed.
removed are referenced in sample
list.
Not possible to add material. All There are no free indexes to assign to
indexes are already used. create a new material. See valid material
index ranges.
Material definition error: the mate- The material definition index must be
rial index is already used. unique in the system. The user has
entered an already assigned material
index.
Material definition error: the The material definition name must be

entered material name is already unique in the system. The user has
used. entered an already assigned material
name.


Material definition error: material Material type cannot be changed if the

type cannot be changed if the material is referenced in tests or QCs.
material is referenced.
Lot specific information: the Within a same material lot definition,

extended expiration date must be the user has entered an extended expi-
later then the expiration date. ration date that is earlier than the nor-
mal expiration date.
Lot specific information: the lot The user has entered the same lot
number is already used. number for both the active and the alter-
nate material lots.
Lot specific information: the lot Within a same material definition, the
definition is already used. user has entered the same expiration
date for active and alternate lot numbers
with the same last 4 digits.
Lot specific information: missing The user did not enter a valid ISI value
or incorrect ISI values. for the active and alternate lot (if ena-
bled).
Scan material data: unknown or Bar code was read but data format is
incorrect bar code data format. not as expected.
Scan material data: this bar code Bar code was read but there is no data
does not contain information for for the TOP instrument.
the TOP instrument.
Saving bar code data error: some Some of the scanned materials intended
of the affected materials are on- to be modified or on-board.
board. Data cannot be saved.
Total default clean volume Material definitions: total clean volume

exceeds syringe volume limits. exceeds syringe volume limits.
Total carry-over clean volume Material definitions: total clean volume

exceeds syringe volume limits. exceeds syringe volume limits.
The vial properties cannot be The vial properties cannot be updated

updated because it is currently because it is currently used in a placed
used in a placed material def- material definition.
inition.
The vial set cannot be updated The vial set cannot be updated because
because it is currently used in a it is currently used in a placed material
placed material definition. definition.

Alarm Messages

Incorrect user name or password. User name or password mismatch.
New password must be different The given new password is equal to the
from the current password. old password.
The user <user name> currently User has exceeded the maximum con-
locked. Please contact your admin- secutive number of allowed attempts to
istrator. log in with an incorrect password.
Your password has expired. Do User password has expired.

you want to change it now?
Your password expires in <n> User password is near its expiration

days. Do you want to change it date.
now?
Confirmed password does not Security setup: confirm password entry

match the password entry. does not match password entry.
The entered user name is already Security setup: the user name is already
used. used in the system.
Invalid warning period. Invalid warning period.
Import process not allowed: sys- The user has required an import data
tem not ready or materials on- action, but the instrument status or the
board. materials placement conditions are not
OK.
The contents of the import data The contents of the import data file do
file do not match the current CM not match the current CM data struc-
data structures. tures.
The selected file does not contain The import file does not contain valid
valid definitions. TOP data.
Error importing material def- The import process was importing an

inition: existing material definition that is on-
- material index: <material index> board.
- material name: <material name>

Material definition cannot be mod-
ified. Material is on-board.
The system database will be
restored to the previous state
before this import process.


Error importing material def- The import process was importing a

inition: material definition with a material name
- material index: <material index> already assigned to another material.
- material name: <material name>

The material is already used.
Error importing test definition: The import process was importing a test
- test number: <test number> definition whose test code is already
- test code: <test code> assigned to another test.
The test code is already in use.
- test number: <test number> definition whose test LIS number is
- test code: <test code> already assigned to another test.
- LIS number: <LIS number>
The LIS number is already in use.
- test number: <test number> definition whose extended test LIS
- test code: <test code> number is already assigned to another
test.
- extended LIS number:
<extended LIS number>
The extended LIS number is
already in use.
- test number: <test number> definition whose parallelism test LIS
- test code: <test code> number is already assigned to another
test.

Alarm Messages

- parallelism LIS number: <par-

allelism LIS number>
The parallelism LIS number is
already in use.
Error importing QC definition: The import process was importing a QC

- QC material: <material name> definition whose result unit was
- test code: <test code> removed from the list of patient units of
the related test definition. This is pos-
- result unit: <result unit>
sible because the patient unit's list is
The QC definition unit was freely editable by non-IL users with
removed form the list of patient appropriate permission.
units of the related test definition.

Error importing QC definition: The import process was importing a

- QC material: <material name> new QC definition resulting in exceed-
- test code: <test code> ing of the maximum allowed number of
QCs per test.
No more QC definitions can be
added for this test, since it would
exceed the maximum allowed
number (<n>) of QC definitions
per test.
The entered profile name is Profile setup: the profile name is

already used. already used in another profile def-
inition.
The entered reflex rule name is Reflex rules setup: the rule name is
already used. already used in another reflex rule def-
inition.
The entered test extension suffix Global definitions: empty or duplicated

is already used. test extensions.
Incorrect syringe volumes or Global definitions: incorrect volumes


inconsistent cuvette volume set- for syringe and/or cuvette volume set-
tings. tings.
During adjusting thermal, tem- Warning message to let the user know
peratures may appear within that during adjusting thermal, tem-
range, but the system is still sta- peratures may appear within range, but
bilizing. the system is still stabilizing.
The <material description> vial Diagnostics, fluid precision test: One of

for fluid precision test is empty. the vials used to perform the fluid pre-
Place a new vial and press OK to cision test didn't have enough liquid to
continue. complete the execution of the test.
Press cancel to abort the pro-
cedure.
Note: <material description> is
"optical control" or "factor dil-
uent"
Place empty container under the Diagnostics, flow rate test: directions to
probe and press the button to start the user about where to place the grad-
the rinse pump for LAS arm (use uated cylinder or empty 20 mL vial and
empty 20 mL vial) - LAS arm how to proceed.
cover aspiration point for sample Only for the LAS instrument.
arm (use graduated cylinder) -
rack S6 position 5.
For reagent arms (use graduated
cylinder)
- rack R3 position 3.
Please remove the following racks Diagnostics, travel to target test: request
and press OK to proceed: all racks to remove racks if Z limit position is
in sample and diluent areas. selected.
Please remove the following racks Diagnostics, travel to target test: request
and press OK to proceed: all racks to remove racks if Z limit position is
in the diluent and reagent areas. selected.
Fluid may flow out of the probe Diagnostics, set valve test: message to
when the valve position is let the user know that changing the
changed. syringe valve position some liquid
could flow out of the probe.

Alarm Messages

Please remove the alignment tool Diagnostics, defining the LAS aspi-
from the LAS track aspiration ration point - semi-automatic procedure:
point. message to remind the user to remove
the alignment tool from the LAS track.
Place the aspiration point align- Diagnostics, defining the LAS aspi-
ment tool at the LAS aspiration ration point - semi-automatic procedure
point to proceed. activity: message to ask the user to
place the alignment tool on the LAS
track aspiration point.
The arm is going to move back Diagnostics, defining the LAS aspi-
into the instrument. ration point - manual procedure activ-
ity: warning message to notify the user
that the arm is going to be moved back
inside the instrument.
Coordinates are: Diagnostics, defining the LAS aspi-

- measured X = <measured X> ration point - manual procedure activ-
mm ity: message to display the measured
- measured Y = <measured Y> coordinates.
mm
- measured Z start LLD = <meas-
ured z-start> mm
- measure Z end LLD = <meas-
ured z-max> mm
Press OK to save or Cancel to
abort.
Lower the LAS probe to the max- Diagnostics, defining the LAS aspi-
imum reachable position in the ration point - manual procedure activ-
sample tube. ity: message to ask the user to move the
probe to zMax position.
Manually raise the LAS probe to Diagnostics, defining the LAS aspi-
the liquid level detection start ration point - manual procedure activ-
position. ity: message to ask the user to move the
probe to the LLD start position.
Place a 20 mL vial containing Maintenance, enhanced clean activity:

Clean B in the LAS cover aspi- message to ask the user to place the vial
ration point. containing the clean material in the
LAS cover aspiration point.
Please remove the Clean B vial Enhanced clean for LAS probe: message


from the LAS cover aspiration to ask the user to remove the clean mate-
point and press OK to proceed. rial.
Please place a 20 mL vial con- Enhanced clean for LAS probe: message
taining Clean B in the LAS cover to ask the user to place the clean mate-
aspiration point. Press OK to pro- rial.
ceed or Cancel to abort.
QC profile error: duplicated name QC profile name is already used by

another QC profile.
One or more of the QCs could not One or more QCs could not be proc-
be processed, probably because essed due to a lack of materials or a test
not all materials are on-board or definition inconsistency.
the test definition is not con-
sistent.
Database fragmentation. It's sug- DB indexes are fragmented. Defrag-

gested that you shut down the mentation is recommended.
application.
High database fragmentation. It's DB indexes are fragmented. Defrag-

highly recommended that you mentation is highly recommended.
shut down the application.
High database fragmentation. The DB indexes are fragmented. Defrag-

application will automatically mentation is mandatory.
shut down.
A software upgrade is in progress. An AM software component is being

Please do not shut down the CM upgraded.
or AM.
Database installation failed The installation of a new database

because installation scripts are not failed because the installation scripts
available in installation scripts were not found in the scripts directory.
directory. Please exit the appli-
cation and reinstall the ACL TOP
application.
Database installation failed. Data- The installation of a new database

base engine is not functioning. failed because the database engine was
Please exit the application and down.
restart the CM to automatically
restart database engine.
Database installation failed. There The installation of a new database

Alarm Messages

is another application using the failed due to existing open connections

TOP database. Please close all to TOP databases.
open applications.
Database installation failed The installation of a new database

because the disk is full. Increase failed because there is not enough free
free space and start again. space on the disk selected for instal-
lation.
Database installation failed. The installation of a new database

failed due to an unknown error.
Database upgrade failed because The upgrade of the database failed

upgrade script is invalid. Exit because the upgrade script was invalid.
application. Reinstall ACL TOP.

there are no upgrades available. because there are no available upgrades.
Exit application.

the database engine is down. The because the database engine was down.
operation cannot be performed.
Exit application. Restart PC to
automatically restart database
engine.
Database upgrade failed due to The upgrade of the database failed due
existing open connections to TOP to existing open connections to TOP
database. Please close all open databases.
database connections first.
Database upgrade failed due to The upgrade to a new database failed

disk full. Increase free space and because there is not enough free space
start again. on the disk selected for upgrade.
Database upgrade failed. The upgrade of the database failed due

to an unknown error.
Startup of database failed; DB Startup of the database failed; DB could

could not connect to MS data not connect to MS data engine.
engine.
The descriptor file is not a valid The restore failed due to an invalid
.xml file. Perform another back up. backup descriptor.


The database restore failed The restore failed because the upgrade
because the ACL TOP application after the restore failed.
installation is invalid. Exit the
DB Backup/Restore application.
Reinstall the ACL TOP appli-
cation. Restart the database restore
operation.
Database backup or restore failed The backup or restore failed because the
because the database engine is database engine was down.
down. The operation cannot be
performed. Exit application.
Restart PC to automatically restart
database engine.
The operation cannot be per- The backup or restore failed due to

formed. Please close all open data- existing open connections to TOP data-
base connections first. bases.
Error writing disk due to disk The backup or restore failed because
capacity exceeded or invalid net- there is not enough free space on instal-
work access. Increase free space lation location or a network error was
and start again. Check network detected.
connections if a network unit was
used.
The restore operation for a CD The backup or restore from a CD failed

failed. Check that provided CD because the CD was corrupted.
has valid format and content. Use
another backup.
Backup or restore could not be The backup or restore failed due to an

performed. unknown error.
LAS definition incorrect syringe The field min. syringe volume has a Save LAS configuration
settings: min. syringe volume value greater than max probe volume (Setup LAS configuration).
greater than max. probe volume. when saving LAS configuration.
LAS definition incorrect syringe The field min. syringe volume has a Save LAS configuration
settings: min. dispense volume value greater than max probe volume (Setup LAS configuration).
greater than max probe volume. when saving LAS configuration.
LAS definition incorrect syringe The field max. sample volume is too Save LAS configuration
settings: max. sample volume too small when saving LAS configuration. (Setup LAS configuration).
small.
LAS definition incorrect syringe The field min. dispense volume has a Save LAS configuration

Alarm Messages

settings: min. dispense volume value less than cuvette blind volume in (Setup LAS configuration).
less than cuvette blind volume. Global Definitions.
LAS definition incorrect syringe The field aliquotting area expiration Save LAS configuration
settings: aliquotting area expi- time has a value greater than LAS sam- (Setup LAS configuration).
ration time greater than LAS sample expiration time.
ple expiration time.
Temperatures are out of range. Do Temperatures are out of range.

you want to initiate the run?
Place a 10 mL vial in the aspi-

ration location <factor diluent
blanking - aspiration location>
filled with no less that 9.5 mL of
factor diluent. Confirm (OK) or
reject (Cancel) the start of the pro-
cedure.
The default file path for the log If the default file path does not exist, Verify the file path spec-
files does not exist and cannot be the system tries to automatically create ification: if it is wrong, cor-
created (possible causes: wrong it. The operation could fail for different rect it and retry. If this is
file path specification; insufficient causes: not the case, verify you
rights to write to the drive; - wrong file path specification have the appropriate write
HW/SW failure of the drive). - insufficient rights to write to the drive permissions or call Service
to repair the drive.
- HS/SW failure of the drive.
There is no write access for the The user does not have write per-
selected default file path for the missions for the log path,
log files.
Placement Test and Profiles win- Add/remove tests operation is not Configure the Program Test
dow not configured. allowed if the Test and Profiles window and Profiles Placement win-
has not been configured. dow (Setup - Display Set-
tings).
Placement Material window not Add/remove material operation is not Configure the Program
configured. allow if the material placement window Materials Placement win-
has not been configured. dow (Setup - Display Set-
tings).
Do you want to upgrade def- The data of the import file comes from a
initions from <latest imported ver- newer version compared to the latest
sion> to <import data version>? version imported to the system.


You are trying to downgrade def- The data of the import file comes from
initions from <latest imported ver- an older version compared to the latest
sion> to <import data version>. version imported to the system.
Are you sure you want to install a
previous version?
You are trying to install the same The data of the import file is the same
version of definitions that is cur- version that is installed in the system.
rently installed <import data ver-
sion>. Are you sure you want to
proceed?
See Also
l Data Flags
l Alarm Buttons
l General Log List
l Troubleshooting Other Problems

Alarm Buttons
Alarm Buttons
Alarm buttons appear in the status bar at the bottom of all ACL TOP instrument screens. The system notifies
you of new alarm messages in the following ways:
l A blinking red or yellow exclamation point appears on the alarm button in the status bar.
l The system provides an audible beep.
The ACL TOP instrument produces two types of alarm messages: Errors and Warnings.
Warning Alarms
A warning message indicates that some user action may be required. Warnings do not affect the operation of
the instrument. However, an error condition may eventually occur if the operator does not perform the
required action.
Warnings are indicated by a yellow exclamation point on the alarm button in the status bar.
Error Alarms
An error message indicates that a condition has been detected that requires immediate action. Failure to act
may result in the instrument performing an emergency stop.
Errors display a red exclamation point on the alarm button in the status bar.
No New Alarms
When an alarm button in the status bar is enabled but without an exclamation point, there are no new alarms.
Alarm Buttons in the Status Bar

The following alarm buttons appear in the status bar.
Alarm Button Alarm Name Description
Material Alarms related to the availability of materials on

board the AM1.

Alarm Button Alarm Name Description
Job Frequency Alarms related to the ability of the analyzer to com-

plete a test.
Quality Control Alarms related to the Quality Control functionality.
Maintenance Alarms that indicate a maintenance operation must be

performed.
Analyzer Alarms related to the AM functionality.
External Communications Alarms related to the host connection or to LAS.

Alarms
See Also
l Status Bar
l Alarm Messages
l Data Flags

Troubleshooting Other Problems
Troubleshooting Other Problems

Instrument problems that do not display alarm warnings, errors, or messages are listed below along with sug-
gested operator actions.
Item Problem Suggested Actions

1 Instrument doesn’t rec- Make sure the bar code label is not damaged or dirty.
ognize rack See Restriction Map.
Verify that you are using a bar code format supported by the system. See
Bar Code Definitions Setup.
Check that the rack flag (the part of the rack that is inserted and
detected) is not broken or defective.
Call Service.
2 Rack labels not Do not continue to use rack as loose labels will cause racks to jam.
secured to rack or fall Clean rack label area carefully so labels are not damaged.
off
3 Rack jams upon inser- Verify that tubes are pushed all the way down into the rack position.
tion Be sure you are using the correct sample containers and sample racks.
See Samples and Restriction Map.
Check that bottles and containers are held on center within rack.
4 Sample tube or rea- Check that there is no buildup on the rack. IL recommends that all
gent bottles/auxiliary exposed surfaces be cleaned as needed with a cloth moistened with 10%
containers not held in bleach solution and rinsed with de-ionized water. Alternatively, Cav-
center within rack icide® can be used for surface decontamination.
Use only sample containers specified for the ACL TOP instrument.
See Sample Containers and Adapters.
Be sure to use correct bottles and correct adapters for the 4 mL and 10
mL reagent bottles. See Reagents and Material Definition.
5 Cuvette supply warn- Call Service.
ing LED doesn’t light
6 Cuvette supply warn- Call Service.

ing LED constantly
on even when cuvette
supply is full
7 Material not stirred Be sure to place material that needs stirring in position 1 or 2 of a rea-
gent rack.
Check that the correct magnetic stir bar (IL Part Number 09746610) is
placed into the bottle with the solution to be stirred. See Material Def-
inition and Parts and Consumables List.
8 Reagent and/or sam- Be sure there is no obstacle preventing the magnetic lock from engag-
ple cover won’t close ing. See Instrument Description/AM Safety Covers.
Call Service.
9 Frequent reagent tem- Remove and clean air filters periodically. Replace air filters as needed.
perature warnings See Parts and Consumables List.

Item Problem Suggested Actions

If problem persists, call Service.
10 Rinse or clean fluid Check that the Rinse or Clean bottle has no cracks. If so, replace rinse or
leak external to instru- clean bottle with an undamaged bottle.
ment Be sure rinse or clean bottle caps are tightened.
Be sure all tubing is intact and connected, without bending or kinking.
If the tubing has holes or is internally clogged, replace tubing assembly.
See Parts and Consumables List and Rinse Fluid or Clean Fluid.
11 Waste fluid leak exter- Check that the waste bottle has no cracks. If so, replace the waste bottle
nal to instrument with an undamaged bottle.
Be sure the waste bottle cap is tightened.
Be sure all tubing is intact and connected, without bending or kinking.
If the tubing has holes or internally clogged, replace tubing assembly.
See Parts and Consumables List and Fluid Waste.
If none of the above cases are true and the waste fluid leak is due to bot-
tle overflow, the waste sensors may be defective. Call Service.
See Also
l Alarm Messages
l Data Flags

Data Flags
Data Flags
Data Flags are associated with test results and can be either warning-level or error-level. Also, data flags are
categorized into groups. See Accessing Data Flags. Data flag codes are always transmitted with the results to
the LIS.
Warning Data Flags

A warning data flag indicates that a test result has been generated, but a condition has been detected, or a
limit exceeded that may affect the quality of the result.
Error Data Flags

An error data flag indicates a condition has been detected, or an error limit exceeded, that will result in no
test results generated.
In normal conditions, samples are displayed on the screen with no flags. If a flag exists, it is displayed in cap-
ital letters, for example, CE (coagulation error), CW (coagulation warning). If a test and/or sample has mul-
tiple flags, the flag with the highest priority is displayed/printed with both capital letters underlined to
indicate that there are more flags beyond what is displayed/printed. All flags and codes are listed in Test
Details screen.
Data Flag Groups

Data flags are categorized into the following groups (listed from highest to lowest priority):
Data Flag Group Description

Blank No error
IU Investigational use only
SE Sampling error
HE Hardware error
CE Coagulation error
RE Individual result error
HC Out of calibration range high
LC Out of calibration range low
HW Hardware warning
CW Coagulation warning
RW Individual result warnings
QC Quality control flag
NP NPP flag
HT Out of test range high
LT Out of test range low
HL Out of linear range high
LL Out of linear range low
HH Out of therapeutic range high (mean value)
LH Out of therapeutic range low (mean value)

Data Flag Group Description

HN Out of normal range high (mean value)
LN Out of normal range low (mean value)
CR Out of calibration range (high or low)
TR Out of test range (high or low)
LR Out of linear range (high or low)
HR Out of therapeutic range (high or low)
NR Out of normal range (high or low)
CA Calibration flag
MT Maintenance flag
ME Material error/warning
NOTE: If you see a data flag group presented on the screen and it is underlined (e.g., HR), there are
additional data flags associated with your result. Also note that the underlined data flag group (e.g., HR) is
the highest priority data flag associated with your sample. All additional data flags are of the same group or a
lower priority group. Therefore, in the HR example, additional data flags could be in one or more of the fol-
lowing groups: HR, NR, CA, MT, or ME on one of more of your tests.
Data Flags List

Data Flags
Code Flag Message Error/ Description
Warning
5000 HE LLD Error E The AM has detected liquid where liquid should not be (a
false positive)
5002 HE Error detected E General ORU error. If the signal check for a particular test is
in ORU disabled, all ORU flags are treated as an error.
5003 HE Air read failure E The reading of the air just prior to acquisition is outside of
the stored air read value plus/minus some tolerance amount.
5004 HE Aspiration E The probe did not stay immerged in the liquid properly dur-
Baseline Error ing an aspiration or the liquid was not properly detected
prior to the aspiration.
5005 HE Unexpected E Liquid has been detected, but it is not in the proper location
LLD Error (it is found too early) so we suspect a false positive reading.
5050 CE (Data) First E Out of starting point range

point out of
range

Data Flags
Data Flags
Warning
5051 CE (Data) Baseline E baseline average too low

average low
5052 CE (Data) Baseline E Baseline SD is out of range

SD exceeds
error limit
5053 CE (Data) Baseline E baseline average too high

average high
5054 CE (Data) End- E Endpoint SD is out of range

point SD
exceeds error
limit
5055 CE (Data) End- E endpoint average too high

point average
high
5056 CE (Data) Too E too many invalid raw - points do not fall within specified sig-
many invalid nal range or have an ORU error associated with them
raw data points
5057 CE (Data) Curve E invalid curve max after min -- curve behaves in an
min. and max. unexpected manner - raw data should go from maxima to
not in correct minima value (on ACL-Advance). User specifies correct
sequence sequence on Top.
5058 CE (Data) Last E curve drifting -- the last point in the raw data is outside spec-
point out of ified % of curve
range
5059 CE (Data) Incorrect E too few or too many data points in curve -- indicates an error
number of raw in scheduler, should never occur.
data points
5060 CE (Data) Nor- E delta of curve invalid -- indicates that raw data does not have
malized curve enough signal across curve
delta too low
5061 CE (Data) Cal- E calculation error -- i.e. divide by zero

culation error

Data Flags
Warning
5062 CE (Coag) First E didn't reach first threshold -- not enough signal in curve to
threshold limit find threshold limit value
not found
5063 CE (Coag) Second E second threshold not found -- not enough signal in curve to
threshold limit find threshold check value and user has configured the algo-
not found rithm to fail if check value not located (otherwise a warning)
5064 CE (Coag) Max E time exceeded -- too much time (or too little time) between
(min) time span threshold limit-check or derivative min-max peaks.
violation
5065 CE (Data) Curve E Unable to determine curve sequence

sequence
unknown
5066 CE (Reaction) Lin- E SD out of range in Linear Regression

ear Regression
SD exceeds
error limit
5067 CE (Range) Below E measured result fails -- does not meet test range (low)
measured result
test range
5068 CE (Range) Above E measured result fails -- does not meet test range (high)
measured result
test range
5069 CE (Data) Missing E ORU Blank correction is enabled, but the Blank value for
ORU blank that channel is unavailable
value
5070 CE (Data) End- E endpoint average too low

point average
low
5071 CE (Coag) First E Not identified any maximum peak meeting the criteria
derivative peak
not found
5072 CE (Coag) Second E No maximum or minimum peak meeting the criteria

derivative peak
not found
5073 CE (Data) Inter- E The Interference Check of the Statistics Algorithm has failed

Data Flags
Data Flags
Warning
ference error
5074 CE (Data) Number E Too many spikes were detected in the data.
of spikes
exceeds error
limit
5075 CE (Params) No E The user has disabled the primary algorithm so there will be
algorithm no measured result
selected
5076 CE (Reaction) Ini- E The slope of the initial part of the reaction curve was greater
tial slope than the maximum slope allowed.
exceeds error
limit
5077 CE (Prep) Insuf- E The AM has detected that there was not enough sample mate-
ficient liquid rial to run the test
detected (Sam-
ple)
5078 CE (Prep) Insuf- E The AM has detected that there was insufficient reagent mate-
ficient liquid rial with which to run the test.
detected (Rea-
gent)
5079 CE (Prep) Liquid E A hardware error has occurred with the probe
level detection
error
5080 CE (Data) Insuf- E Due to points being removed from the original data curve
ficient points due to either the signal check, the spike removal check, or
remaining for the moving SD check, the number of points in the remaking
calculation data curve is too few to perform an operation that requires a
specific number of data points.
5081 CE (ORU) Hard- E A hardware error has occurred that will prevent the measured
ware error result from being computed
5082 CE (Prep) Missing E A missing dispense rinse and/or clean step has been detected
post dispense by the SW. Due to a SW error, a post dispense rinse and/or
rinse/clean clean step was not performed.
detected
5083 CE (Data) Nor- E The delta of the sample is less than the delta of the lowest
malized curve calibrator (minus some tolerance amount).
delta less than

Data Flags
Warning
lowest cal-
ibrator delta
5084 CE (Coag) Too E Too many peaks were found within the first derivative and
many first deriv- the specified window, indicating that the data curve is noisy.
ative peaks
5085 CE (Coag) Too E Too many peaks were found within the second derivative
many second curves specified window, indicating that the data curve is
derivative noisy.
peaks
5086 CE (Data) Result E The measured result is more negative than the maximum neg-
exceeds Neg- ative value allowed (zero if no negative values are allowed)
ative Value
Limit
5087 CE (Data) Result E The Result Check measured result failed.

Check failed
5088 CE (Prep) Aspi- E Error when performing the aspiration baseline check
ration Baseline
Error
5089 CE (Prep) E AM reported an unexpected LLD error

Unexpected
LLD Error
5090 CE (Prep) Material E AM reported a material dispense error. An unexpected mate-

dispense error rial dispense error was detected by the AM software. Not
expected behavior.
5091 CE (Data) Nor- E delta of curve invalid -- indicates that raw data exceeds
malized curve allowed signal change across curve
delta too high
5092 CE (Data) Nor- E The threshold error value is found more than one time in the
malized data data and the time between each of the consecutive occur-
contains mul- rences of the threshold is greater than the defined time span.
tiple thresholds
5100 RE Measured result E The result unit is the measured result and DR has been
failed unable to compute it
5101 RE NPP undefined E ratio denominator undefined. This could occur if not properly
set up by the user or, in the case of an NPP material, if it was

Data Flags
Data Flags
Warning
not executed prior to computing results that require it.
5102 RE NPP failed E NPP result used in result calculation is failed.
5103 RE ISI undefined E ISI value undefined
5104 RE Estimation E result cannot be calculated

failed
5105 RE Paired partner E The result is based on paired tests and one of them is not
test not avail- available due to being not configured properly.
able
5106 RE Paired partner E The result is based on paired tests and one or both of them
test failed are failed
5107 RE Inconsistent E The paired results do not have consistent result units with
test units which to perform the paired result calculation. If using the
between paired measured result, the measured result units must be the same
tests (i.e. both seconds). If using the calibrated result unit, the cal-
ibrated result units must be the same (i.e. both % activity).
5108 RE Unable to com- E Unable to compute the Corrected Result for this deter-
pute par- mination and/or concentration
allelism CR
5109 RE Unable to com- E Unable to compute the mean of the corrected result (CR)
pute par- excluding the 100% parallelism concentration.
allelism mean
of CR
5110 RE Unable to com- E Unable to compute the mean of the corrected result (CR)
pute par- including the 100% parallelism concentration
allelism mean
of CR and
100%
5111 RE Unable to com- E Unable to compute the mean result of the 100% parallelism
pute par- concentration
allelism mean
100%
5112 RE Unable to com- E Unable to compute the %CV of the corrected result (CR)
pute par- from each concentration excluding the 100% concentration
allelism %CV
of CR

Data Flags
Warning
5113 RE Unable to com- E Unable to compute the %CV of the Corrected Result (CR)
pute par- from each concentration including the 100% concentration
allelism %CV
of CR and
100%
5114 RE Unable to com- E

pute par-
allelism slope

pute
parallelism y-
intercept

pute par-
allelism r2
5117 RE Below Sec- E The result value was computed using the secondary algo-
ondary Algo- rithm and was less than the minimum value allowed.
rithm Range
5118 RE ISI value unde- E Unable to obtain ISI value because the lot of material is no
fined. Lot not longer defined.
defined.
5119 RE Active cal- E The calibrated unit in the active calibration does not match
ibration unit the calibrated unit in the calibration definition. User mod-
and calibration ified the calibration unit in the test definitions and has not
unit in the test recalculated or run the calibration.
definition do
not match
5120 RE Maximum neg- E The result value was negative and was more negative than
ative value allowed for this unit.
exceeded
5121 RE Above Sec- E The result value was computed using the secondary algo-
ondary Algo- rithm and was greater than the maximum value allowed.
rithm Range
5190 HW Temperature W Generic flag indicating that at least one temperature reading
out of range was out of range. All temperature out of range alarms are
mapped to a single flag within each determination
5191 HW Warning W Generic ORU warning. If signal checks are enabled in the

Data Flags
Data Flags
Warning
detected in test definitions for the particular test, all ORU flags are
ORU treated as warning.
5192 HW Material stir- W The AM has detected that the material stirring mechanism is
ring warning not stirring the material and this is a coagulation test (stirring
prolongs material stability)
5200 CW (Data) First W Out of starting point range

point out of
range
5201 CW (Data) Baseline W Baseline SD is out of range

SD exceeds
warning limit
5202 CW (Data) Baseline W Baseline average too low

average low
5203 CW (Data) Baseline W Baseline average too high

average high
5204 CW (Data) Invalid W At least one data point has been found out of the acceptable
point(s) range or with an ORU flag associated with it.
5205 CW (Data) End- W Endpoint SD is out of range

point SD
exceeds warn-
ing limit
5206 CW (Data) End- W endpoint average too low

point average
low
5207 CW (Data) End- W endpoint average too high

point average
high
5208 CW (Data) Delta of W curve delta below valid delta

Curve Lower
Limit below
warning limit
5209 CW (Coag) Maxima W first derivative peak below limit

of 1st deriv-
ative below
warning limit

Data Flags
Warning
5210 CW (Coag) Maxima W 2nd derivative maxima peak below limit

of 2nd deriv-
ative below
warning limit
5211 CW (Coag) Minima W 2nd derivative minima peak below limit

of 2nd deriv-
ative is below
warning limit
5212 CW (Reaction) Lin- W maximum SD exceeded for linear regression

ear regression
SD exceeds
warning limit
5213 CW (Coag) Second W second threshold not found

threshold limit
not found
5214 CW (Coag) Max W time exceeded on threshold/derivative check

(min) time vio-
lation
5216 CW (Data) Last W curve drifting -- the last point in the raw data is outside spec-
point out of ified % of curve
range
5217 CW (Coag) 1st W max peak to baseline delta below minima

derivative peak
delta below
warning limit
5218 CW (Coag) 1st W max peak to baseline delta percent lower than warning limit
derivative max
peak delta %
below warning
limit
5219 CW (Coag) 2nd W peak delta below minima

derivative peak
delta below
warning limit
5220 CW (Coag) 2nd W peak delta percent lower than warning limit
derivative peak
delta % below

Data Flags
Data Flags
Warning
warning limit
5221 CW (Data) Inter- W The Interference Check of the Statistics Algorithm failed.
ference warn-
ing
5222 CW (Data) Number W At least one spike has been detected in the data
of spike(s)
exceeds warn-
ing limit
5223 CW (Reaction) Ini- W The initial slope of the reaction curve is greater than the spec-
tial slope ified warning limit
exceeds warn-
ing limit
5224 CW (Coag) Deriv- W The clotting time selected for the derivative curve cor-
ative first point responds to the first data point in the derivative curve
5225 CW (Coag) Thresh- W The result found using the backwards threshold check is not
old Check within the valid range of the result found using the first or
second derivative algorithm.
5227 CW (Data) Nor- W The delta of the normalized data curve is less than the warn-
malized curve ing tolerance amount based upon the delta of the lowest cal-
delta less than ibration point.
lowest cal-
ibrator delta
5228 CW (Coag) 2nd W max peak to baseline delta below minima

derivative max
peak delta
below minima
5229 CW (Coag) 2nd W max peak to baseline delta percent lower than warning limit
derivative max
peak delta %
below warning
limit
5230 CW (Data) Result W The algorithm used with the result check produced a failed
Check failed measured result.
5231 CW (Data) Delta of W curve delta above valid delta

Curve Upper
Limit above

Data Flags
Warning
warning limit
5232 CW (Data) Nor- W The threshold warning value is found more than one time in
malized data the data and the time between each of the consecutive occur-
contains mul- rences of the threshold is greater than the defined time span.
tiple thresholds
5250 RW Missing deter- W Less determinations than currently configured

minations
5251 RW Too many con- W More concentrations than currently configured

centrations
5252 RW %Max dif- W Max Difference between replicates greater than allowed
ference of rep-
licates
exceeded
5253 RW Max. variance W The difference between each dilution and the 100% dilution
of parallelism of the parallelism result is exceeded
dilution out of
range
5254 RW Slope out of W

range
5255 RW Parallelism r2 W
out of range
5256 RW Too many deter- W More determinations than currently configured

minations
5257 RW Missing con- W Less concentrations than currently configured

centrations
5259 RW %CV of the W Calculated CV exceeds the limits

CR is greater
than the max-
imum %CV
allowed
5260 RW %CV of the W Calculated CV exceeds the limits

CR and the
100% dilution
is greater than
the maximum

Data Flags
Data Flags
Warning
%CV allowed.
5261 RW Parallelism has W Calculated variance exceeds the limits

one or more
dilutions that
exceeds the
max.variance
5262 RW Results recal- W This test has had its results recalculated.
culated
5266 RW DR warning on W The measured result that was used to compute this result had
measured result a warning associated with it.
5267 RW One or more W One or more replicate result(s) is failed.

failed replicates
5301 QC QC overdue E The expiration date for a QC has been reached.
5302 QC QC failed E QC rules have failed. It is a hint to detect problems in the

measurement.
5400 NP NPP has warn- W NPP used to compute result had a warning (only true if NPP
ing is configured to run as a material). This flag may be set for
paired results (that use NPP in their calculation) as well as R
and INR results. The flags within the NPP sample that will
result in this flag are the following:
1. There is a warning on the NPP measured result
2. There is an error on the NPP measured result
3. There is a warning on the NPP calibrated result (if com-

puted)
3. The measured result is outside of one of the enabled

ranges
4. One of the materials used to generate the NPP sample has

expired
5. One of the materials used to generate the NPP sample has

expired stability

Data Flags
Warning
6. The NPP frequency has expired
7. A maintenance procedure was expired or failed when the

NPP material was run
5401 NP NPP overdue E Job executed when NPP frequency was expired.
5500 HT Above Test W One or more results is out of test range high
Range
5501 LT Below Test W One or more results is out of test range low
Range
5502 HL Above Linear W One or more results is out of linear range high
Range
5503 LL Below Linear W One or more results is out of linear range low
Range
5504 HH Above Ther- W One or more results is out of Therapeutic range high
apeutic Range
5505 LH Below Ther- W One or more results is out of Therapeutic range low
apeutic Range
5506 HN Above Normal W One or more results is out of Normal range high
Range
5507 LN Below Normal W One or more results is out of Normal range low
Range
5508 HC Above Extrap- E The computed calibrated result value is greater than the max-
olation Range imum calibrated result value allowed.
5509 LC Below Extrap- E The calibrated result value is less than the minimum value
olation Range allowed for a calibrated result.
5510 CR One or more W One or more results is out of Calibration Range

results are out
of Calibration
Range (High or
Low)

Data Flags
Data Flags
Warning
5511 TR One or more W One or more results is out of Test range. One of the results
results are out has a out of test range flag on the result
of Test Range
(High or Low)
5512 LR One or more W One or more results is out of Linear range

results are out
of Linear
Range (High or
Low)
5550 CA Valid cal- W Calibration has been disabled or there is no validated cal-
ibration is not ibration with the same reagent lots or the validated cal-
available ibration is failed and the job requires a calibration to
complete its result computations.
Calibration is imported by results data from a non-validated

or non existing master calibration.
5551 CA Calibration E Job has been executed with the calibration in overdue status.
overdue
5552 CA Calibration esti- E calibration does not have result

mation failed
5553 CA Calibration E calibration slope out of range

slope out of
range
5554 CA Calibration r2 E Coefficient of determination out of range

out of range
5555 CA Calibration E not enough "good" points

failed due to
lack of data
5556 CA Calibration y- E y-intercept out of range

intercept out of
range
5557 CA Calibration E The %CV of a particular dilution is greater than the max-
%CV of dilu- imum CV allowed
tion exceeded
5558 CA Calibration has E Calculated CV exceeds the limits

one or more
dilutions that

Data Flags
Warning
exceeds %CV
5560 CA First and last E The measured results of the calibration are not valid. The
calibration data generated is not consistent with what is expected for cal-
points cannot ibration data. The measured result value of the highest con-
be the same centration must be different than the measured result value of
the lowest concentration.
5563 CA Calibration E The minimum number of replicates for the particular dilution
minimum do not have good result values.
number of rep-
licates for dilu-
tion is not
found.
5564 CA Calibration has E At least one dilution does not have the minimum number of
one or more replicates as specified.
dilutions that
do not have the
minimum
number of rep-
licates
5565 CA Calibration E The lot of material that was used to generate the original cal-
failed. Lot not ibration results is no longer defined and therefore the cal-
defined. ibration cannot be recalculated.
5566 CA Calibration E The results of the calibration do not follow a consistent

results trend trend, either all values must increase or all values must
not consistent decrease, but they cannot increase and decrease as the con-
centration levels change
5567 CA Calibration E The calibration curve will be flagged as not monotonic, if

curve not mon- the monotonic check is enabled and detects multiple results
otonic for the one or more measured value in one or more segment
within the tested range. For Spline calibrations, the range is
the limit of the spline calibration points. For Polynomial cal-
ibrations, the range is the limit of the extrapolation range.
5568 CA Calibration and W Calibration transformations do not match parallelism trans-

parallelism formations. User modified the parallelism transformation
transformations values and has not recalculated the calibration results.
do not match
5600 MT Maintenance W Job executed with some maintenance activity in overdue

overdue or status.

Data Flags
Data Flags
Warning
failed
5650 ME Material sta- W One or more materials stability has expired for this deter-
bility mination
5651 ME Material W One or more of the materials used to run this determination
expired has expired.
5653 ME Alternate lot in W An alternative lot was in use when the job was run
use
5654 ME Alternate lot in W An alternative lot was used for jobs that this job uses to com-
use pute results.(Calibration, NPP or master job)
5657 ME One or more E Remaining stability for last vial expired.

determinations
has a material
stability warn-
ing
5658 ME One or more E The present date is greater than the expiration date of the last
determinations available vial/lot.
has a material
expiration warn-
ing
5659 ME One or more W The stirring mechanism for a material requiring stirring is no
determinations longer functional.
has a material
stirring warn-
ing
5660 ME LAS Sample W LAS Sample Expired during processing

expired during
processing
5700 SE Volume Track- E Error indicating that there was insufficient sample to pipette.
ing - Insuf- This error flag is set by the analyzer when, aspirating from a
ficient Liquid rack container containing sample, liquid is not found or the
(Sample) available liquid volume is less than the volume to be aspir-
ated
5701 SE Volume Track- E The AM determined that there was insufficient reagent to
ing - Insuf- pipette. This error flag is set by the analyzer when, aspirating
ficient Liquid from a rack container containing a liquid that is NOT patient
(Reagent) sample, liquid is not found or the available liquid volume is
less than the volume to be aspirated

Data Flags
Warning
5702 SE Missing post E Error indicating missing dispense of rinse or clean was
dispense detected in the software. Due to timing issues in the
rinse/clean scheduler. Because of a SW error a post dispense clean or
detected rinse step is not performed. This check is done for safety pur-
poses.
5703 SE Material dis- E Because of a scheduling error, a material that should have
pense error been dispensed into the reaction cuvette was not dispensed.
This check is done for safety purposes and it is intended that
this error will never be seen.
5800 IU For Inves- W The test parameters have been developed for investigational
tigational Use use only.
Only
5801 IU Software in W The instrument is running experimental or debug version soft-

experimental ware and/or an IL Service or an IL Specialist is currently
operation logged on.
and/or Service
or Specialist AM SW has been told to run in a special mode (fake LLD,
logged-in disable heartbeat, short init, etc) via the CM.INI file.
NA (not CA Calibration W The user has deleted this calibration point (measured result)
displayed point deleted and it is no longer used to compute the calibration results
as text)
NA (not CA Point is con- W Data Reduction has automatically removed this calibration
displayed sidered an out- point from use when computing the calibration curve
as text) lier because the user has enabled outlier removal, there are at
least 3 measured results with values for this concentration
and this value is the outlier.
* For calibrations combined with dilutions, where some of the replicates have CW flags, the calibration is
still acceptable. The calibration can be validated as long as the DR Parameters (r2 and %CV check) meet the
criteria used for acceptability. The results with CW warnings show as italicized numbers and the warning
code is seen on the reactions information screen. The sample results derived from these calibrations do not
have any flags associated with them indicating that the result is based on the calibration that contained a
coagulation warning(s).
See Also
l Accessing Data Flags
l Alarm Messages
l Troubleshooting Other Problems

Accessing Data Flags

You can view data flags in the following areas of the ACL TOP instrument:
Sample List
To view data flags in the Sample List:
2. View the data flags in the Sample Highest Error column headed by a red exclamation point . The
highest priority data flag group is displayed for each sample.
See Sample List.
See Sample List Display Settings to display hidden columns.
Sample Details Screen

To view data flags on the Sample Details screen:
3. Select the Test Information tab in the Sample Details screen.
4. View the data flags in the Test Highest Error column headed by a red exclamation point . The
highest priority data flag group is displayed for each sample.
See Sample Details.

Test Details Screen

To view data flags on the Test Details screen:
4. In the Test Information tab place focus on a test and select the Test Details icon in the toolbar
to open the Test Details screen.
5. <Optional> Select the Previous Test and Next Test icons in the toolbar to scroll
through the test results for the sample ID in focus in the Sample List.
6. View the data flags in the Errors and Warnings section. All data flags (group and description) are dis-
played for each replicate and test unit.
See Test Details.
Calibration Details Screen

To view data flags on the Calibration Details screen:
2. In the Calibration Status List, double-click a test code, or select a test code and select the Cal-
ibration Details icon in the toolbar. By default, the Calibration Details screen opens dis-
playing the validated calibration. If a test has no validated calibration, the Calibration Details screen
displays Calibration 1.
3. Select one of the following tabs and view data flags in the Errors and Warnings area.
l Calibration Information tab – Data flags appear specific to the calibration.

l Reaction Information tab – Data flags appear for replicate and test unit.
See Calibration Details.

QC Statistics Screen
To view data flags on the QC Statistics screen:
2. Double-click a material name or test code in the Results List to open the QC Statistics screen.
3. View the data flags in the Error Status column headed by a red exclamation point . If a check
mark appears in that column, click it to see a list of all data flags (group and description).
See Reviewing QC Results.
NPP Details Screen

To view data flags on the NPP Details screen:
2. Double-click a test in the NPP Status List.
3. Select one of the following tabs and view data flags in the Errors and Warnings area.
l General Information tab – Data flags appear that are not specific to the reaction.
l Reaction Information tab – Data flags appear that are specific to the reaction.
See NPP Status Details.
See Also
l Data Flags
l Sample List
l Sample Details
l Test Details
l Calibration
l QC Statistics
l NPP Details


CHAPTER 13 System
CHAPTER 13
SYSTEM
Maintenance Schedule
The ACL TOP instrument is a precision instrument. To maintain it in good functional condition, IL rec-
ommends the following operations be carried out by a trained operator at the specified frequencies.
NOTE: For the best possible results, keep the instrument powered ON at all times. The standby con-
dition consumes minimum power and rinse fluid while affording maximum readiness for operation.
Daily Maintenance
During operation the automatic rinse and clean cycles are performed by the instrument, thus reducing to a
minimum the daily maintenance operations required of the operator.
Once each day the operator must perform the following maintenance activity:
l Enhanced clean for all probes
See Performing Maintenance Activities for instructions on how to perform the enhanced clean.
The time required by the system to perform the Enhanced clean for all probes is about 5 minutes.
Weekly Maintenance
Once each week the operator must perform the following maintenance activities:
l Clean the Cuvette Waste Drawer.
l Wipe-down Sample Probe.
l Wipe-down LAS Probe.
See Perform a Maintenance Activity for instructions on how to perform the above.
Monthly and Quarterly Maintenance

No maintenance activity is currently scheduled to be performed on a monthly or quarterly basis.

Chapter 13 – System
Annual and Semi-Annual Maintenance

l Preventive maintenance is to be performed by authorized Service personnel every 6 months.
l It is recommended that Syringe Tip Replacement be performed every 6 months.
As Needed Maintenance
l Automatic Fluidic Line Priming Cycle.
l Automatic Routine Clean for all Probes
l Clean Rack Areas
l Cuvette Evacuation Cycle
l Enhanced Clean for LAS Probe
l Enhanced Clean for Reagent 1 and Reagent 2 Probes
l Enhanced Clean for Reagent 1 Probe
l Enhanced Clean for Reagent 2 Probe
l Enhanced Clean for Sample Probe
l Replace LAS Syringe
l Replace Reagent 1 Syringe
l Replace Reagent 2 Syringe
l Replace Sample Syringe
l Rinse/Clean Priming Cycle for all Probes
l Rinse/Clean Priming Cycle for LAS Probe
l Rinse/Clean Priming Cycle for Reagent 1 Probe
l Rinse/Clean Priming Cycle for Reagent 2 Probe
l Rinse/Clean Priming Cycle for Sample Probe
l Routine Clean for all Probes
l Wipe-down all Probes
By Number of Piercings Maintenance

l Replace CTS Filter and clean Clean Cup Area every 5000 cap piercings.

Maintenance Schedule
Good Laboratory Practice

As part of good laboratory practice, the operator is responsible for making sure that the system is kept clean.
Visually inspect the system (sample and reagent areas, cuvette drawer, etc.) and perform maintenance activ-
ities as needed. See Performing Maintenance Activities for instructions.
Different laboratories may require different maintenance schedules. See Viewing and Configuring a Main-
tenance Activity and Adding a New Maintenance Activity for customization.
NOTE: When importing a maintenance activity, the Frequency field is overwritten if the imported
activity is more frequent than the system default frequency. Frequency is not overwritten if the imported activ-
ity is less frequent than the system default frequency.
See Also
l Maintenance Definitions
l Viewing and Configuring a Maintenance Activity

Maintenance List
Accessing Maintenance Activities

To access Maintenance activities:
1. Select System > Maintenance to open the Maintenance List.
2. Double-click a maintenance activity in the table to review its definition in the Maintenance Activity
Configuration window.
3. To perform a maintenance activity, select1 the activity in the list, and select the Perform icon
in the toolbar, or select Actions > Activity > Perform in the menu bar.
Filtering the Maintenance List

To filter the table on the Maintenance List:
2. Select the Filter icon in the toolbar.

3. Configure the filter options in the Maintenance Activity Filter.
l If you select Manual from the Activity Type drop down list then select Apply Filter,
only manual activities are displayed on the Maintenance screen.
l If you select both Manual Activity Type and Overdue from the Frequency Status drop
down list, only manual activities that are overdue are displayed.
l If you also select Annual from the Frequency drop down list, only annual manual activ-
ities that are overdue are displayed.
l The All Activities option removes all filters.
one object.

Maintenance List
Printing the Maintenance List

To print the Maintenance List:
2. Select the Print icon to print the Maintenance screen. Whatever activities are displayed using
the filter option are printed, including all the fields for each activity.
NOTE:
l The Enable Warning Threshold option on the Maintenance Activity Configuration dialog box spec-
ifies whether a warning message is generated when the activity is due.
l IL pre-defines automatic and semi-automatic maintenance activities. You cannot add or delete these
activities. However, you can modify these maintenance activities if you have the appropriate security
privileges.
l You can add, delete, or modify any manual maintenance activity, regardless of whether it was created
by IL or not.

Maintenance Actions Menu
Configuration
Opens a submenu containing the Filter and Warning Thresholds menu options:
Filter
See Filter the Maintenance List.
Opens the Maintenance Activity Filter window, where you can configure the types of activities to display in
the Maintenance Activity Table. It contains the following fields:
NOTE: You can select multiple options. For example, you can filter on Activity Type = Semi-Auto-
matic and Frequency Status = OK and Frequency = Every 6 months.
Filter Options
l Enable filter by activity – Select one of the following:
o Manual
o Semiautomatic
o Automatic
l Enable filter by frequency status – Select one of the following frequency statuses:
o OK
o Due
o Overdue
l Enable filter by frequency – Select one of the following frequencies:
o Annually
o Every 6 months
o Every 3 months
o Monthly
o Weekly
o Daily

Maintenance List
o Number of tests
o Number of piercings
o As needed
l All activities – Displays all maintenance activities in the Maintenance Activity Table.
W arning Thresholds
Opens the Maintenance Warning Threshold Configuration window where you can define the warning thresh-
old for each frequency (For example: Number of piercings for activity, Number of tests for activity, Daily
activities, Weekly activities, etc.). See Warning Thresholds.
Activity
Opens a submenu containing the Add, Delete and Perform menu options:
A dd
Adds a manual maintenance activity. See Add New Maintenance Activity.
D elete
Deletes the selected manual maintenance activity.
Perform
Performs the selected maintenance activity. See Performing Maintenance Activities.
Print Preview
Opens a submenu containing the Print Preview Maintenance Activities Report and Print Preview Main-
tenance Log Report menu options:
Print Preview Maintenance A ctivities R eport

Previews the Maintenance List Report that contains the all the maintenance procedures available on the
ACL TOP instrument and their configurations.
Print Preview Maintenance Log R eport

Opens the Print Maintenance Log Report Filter dialog box where you can filter the information to display
on the report. Click OK to preview the Maintenance Log Report. Select the All log entries option to print a
complete log report of all maintenance activities that have been performed on the ACL TOP instrument.
Print
Opens a submenu containing the Print Maintenance Activities Report and Print Maintenance Log Report
menu options:

Print Maintenance A ctivities R eport

Prints the Maintenance List Report that contains the all the maintenance procedures available on the ACL
TOP instrument and their configurations.
Print Maintenance Log R eport

on the report. Click OK to print the Maintenance Log Report. Select the All log entries option to print a
complete log report of all maintenance activities that have been performed on the ACL TOP instrument.
Export
Opens a submenu containing the Export Maintenance Activities Report and Export Maintenance Log
Report menu options:
Export Maintenance A ctivities R eport

Exports the Maintenance List Report that contains the all the maintenance procedures available on the ACL
TOP instrument and their configurations. In the Export dialog box, select the Format and Destination in the
respective fields, then click OK.
Export Maintenance Log R eport

on the report. Click OK to export the Maintenance Log Report. Select the All log entries option to export a
complete log report of all maintenance activities that have been performed on the ACL TOP instrument. In
the Export dialog box, select the Format and Destination in the respective fields, then click OK.
See Exporting Data.
Review
Opens a submenu containing the Previous screen and Activity Definition menu options:
Previous screen
Returns you to the previous screen.
A ctivity D efinition
Opens the Maintenance Activity Configuration window where you can review the selected maintenance def-
inition.

Maintenance List
Operations Toolbar
Add New Maintenance Activity
Activity Definition
Delete Item
Perform Activity
Warning Thresholds
Filter Maintenance List
Print

Maintenance Activity Table
Description
This column lists the activities that can be performed in Maintenance. These activities include both IL-
defined and user-defined activities.
Type
This displays whether the activity is a Manual, Semi-Automatic, or an Automatic Maintenance activity.
l Manual – Performed by the operator.
l Semi-Automatic– Performed by the instrument with some operator instructions.
l Automatic – Performed by the instrument without any operator instructions.
IL Predefined Activity
A check mark indicates the maintenance activity is an Instrumentation Laboratory predefined activity.
Frequency
The frequency at which the maintenance activity is configured to run. Options include the following:
l Annually
l Every 6 Months
l Every 3 Months
l Monthly
l Weekly
l Daily
l Number of Tests

Maintenance List
l As Needed
l Number of Piercings
# Tests or Piercings
A value indicates that the maintenance activity is performed after the specified number of tests have run, or
the specified number of piercings has occurred.
Frequency Status
This column displays one of the following values:
l <blank> – Activity is performed automatically or on an As Needed basis.
l OK – Activity is not due to be executed.
l Due – If the activity’s Warning parameter is enabled and the current date/time or number of tests is
within the warning threshold, the activity needs to be executed.
l Overdue – The time for the execution of the activity has been exceeded.
NOTE: Some maintenance activities can be performed individually or as a group activity. For exam-
ple, if you individually perform the Rinse/Clean Priming Cycle for the Reagent 1 Probe, the Reagent 2
Probe and the Sample Probe, each activity's frequency status updates, but the frequency status for the group
activity Rinse/Clean Priming Cycle for All Probes does not update. However, if the group activity is per-
formed, the status of the group activity and all the included individual activities are updated.
Last Execution D&T

This column displays the date and time of the last execution of the activity.
Next Execution D&T

This column displays the date and time the next execution of activity is due to be performed, providing a
time interval has been defined for that activity.
Cover Open
A check mark indicates the maintenance activity requires the cover(s) to be open before performing the activ-
ity.
See Also
l Viewing and Configuring Maintenance Activities
l Deleting a Maintenance Activity
l Warning Thresholds

Viewing and Configuring a Maintenance Activity
Viewing and Editing a Maintenance Activity

To view and edit a maintenance activity:
1. Select System > Maintenance in the menu bar.
2. To filter the Maintenance List, select the Filter icon in the toolbar, configure the filter options,
and select Apply Filter.
3. Place focus1 on the maintenance activity to view.
4. Select the Activity Definition icon in the toolbar to open the Maintenance Activity Con-
figuration dialog box. This fields vary depending on the activity selected.
5. After viewing, select Cancel to close the dialog box without saving.
6. To edit the maintenance activity, edit the configuration parameters and select OK.
Adding a Maintenance Activity

To add a maintenance activity:
2. Select the Add icon in the toolbar, or select Actions > Activity > Add in the menu bar.
3. In the Maintenance Activity Configuration dialog box, configure the maintenance activity, and select
OK.
4. The new activity appears in the Maintenance Activities List.
Configuring a Warning Threshold

See Warning Thresholds.

Maintenance Activity Configuration dialog box

Example 1 – Rinse/Clean Priming Cycle
The following Maintenance Activity Configuration dialog box opens for Rinse/Clean Priming Cycle for All
Probes, a semi-automatic activity.
IL Locked
For authorized service personnel only.
Ensures critical maintenance activities are not modified.
When this option is enabled you can only select and deselect the Enable warning threshold option.
When this option is disabled you can configure the rinse, clean and syringe strokes activities.

Example 2 – Enhanced Clean for All Probes

The following Maintenance Activity Configuration dialog box opens for the Enhanced Clean for All Probes
activity.
Frequency
Drop down list where you select one of the following time intervals to run the activity:
l Annually
l Every 6 Months
l Every 3 Months
l Monthly
l Weekly
l Daily
l Number of Tests
l As Needed – If selected, you cannot configure a warning threshold.

IL Locked
For authorized service personnel only.
Ensures critical maintenance activities are not modified.
When this option is enabled you can only select and deselect the Enable warning threshold option.
When this option is disabled, you can configure the following fields:
l Clean Material
l Airgap
l Material Volume
l Transport Airgap
l Hold Time
l Agitation
l Aspiration Number
l Rinse Time After Clean
l Clean Cycle Number for:
l sample probe
l reagent probe
l LAS probe
l Air Gap
l Material Volume
l Transport Air Gap
See Also
l Maintenance List

Adding a New Maintenance Activity

You can add only a manual maintenance activity.
You cannot add automatic or semi-automatic maintenance activities.
Adding a New Manual Maintenance Activity

To add a new manual maintenance activity:
1. Select System > Maintenance in the menu bar to open the Maintenance List.

3. In the Maintenance Activity Configuration dialog box, enter a description of the maintenance activ-
ity. The Description field accepts up to 70 alphanumeric characters.
4. Select a frequency in the Frequency drop down list. If you select Number of tests as the frequency, a
field is enabled where you specify the number of tests for the frequency interval.
5. <Optional> Select the Enable warning threshold and/or Cover opening required option, as nec-
essary.
6. Select OK. The new manual maintenance activity appears in the Maintenance List.
Maintenance Activity Configuration dialog box
Enable warning threshold

Option to generate a warning before the activity is due. See Warning Thresholds. This option is not available
for the As needed frequency.
C over opening required

When this option is selected, the instrument cover must be opened before performing the activity.
See Also

Adding a New Maintenance Activity

l Maintenance List

Deleting a Maintenance Activity

You can delete only manual maintenance activities. You cannot delete semi-automatic or automatic main-
tenance activities.
To delete a maintenance activity:
1. Select System > Maintenance to open the Maintenance screen.
3. Select1 the maintenance activity to delete.
4. Select the Delete icon in the toolbar, or select Actions > Activity > Delete in the menu bar.
5. Confirm the deletion when prompted.
See Also
l Deleting an Item
l Maintenance List
one object.

Maintenance Definitions
NOTE: Maintenance activities specific to any given TOP Family model are displayed on that TOP
model's Maintenance Activities screen. For example, a maintenance activity such as Enhanced Clean for LAS
Probe is only displayed on the Maintenance Activities screen on an LAS instrument.
The following are maintenance activities for all the ACL TOP instruments covered in this manual.
See Also
Automatic Fluidic Line Priming Cycle

See Automatic Fluidic Line Priming Cycle.
Description Automatic Fluidic Line Priming cycle
Frequency As Needed
Enable warning threshold Disabled
Cover opening required Disabled
Duration of rinse pumping 2
Duration of clean pumping 2
Number of syringe strokes 2

Automatic Routine Clean for All Probes

See Automatic Routine Clean for All Probes.
Description Automatic Routine Clean for All Probes
Frequency As Needed
Air gap 15
Material volume 130
Hold time 0
Agitation Disabled
Aspiration number 1
Rinse time after clean 1
Clean cycle number 1
LAS arm:
Air gap 50
Material volume 750
Clean Cuvette Waste Drawer

See Clean Cuvette Waste Drawer.
Description Clean Cuvette Waste Drawer
Frequency Weekly
Enable warning threshold Enabled

Clean Deep Wash and Clean Cup Area

See Clean Deep Wash and Clean Cup Area.
Description Clean Deep Wash and Clean Cup Area
Frequency Weekly
Enable warning threshold N/A – TOP 700 (includes TOP Base)

N/A – TOP 700 LAS
Disabled – TOP 700 CTS (includes TOP CTS)
Disabled – TOP 500 CTS
Disabled – TOP 300 CTS
Cover opening required Enabled *
Clean Rack Areas

See Clean Rack Areas.
Description Clean Rack Area
Frequency As Needed
CTS Foot Cleaning

See CTS Foot Cleaning.
Description CTS Foot Cleaning
Frequency As Needed
Cuvette Evacuation Cycle

See Cuvette Evacuation Cycle.
Description Cuvette Evacuation Cycle
Frequency As Needed

Empty Cuvette Waste – Daily (Manual Activity)

See Empty Cuvette Waste.
Description Empty Cuvette Waste
Frequency Daily
Empty Waste Fluid – Daily (Manual Activity)

See Empty Waste Fluid.
Description Empty Waste Fluid
Frequency Weekly

Enhanced Clean for All Probes

See Enhanced Clean for All Probes.
Description Enhanced Clean for All Probes
Frequency Daily
Clean material Clean B
Air gap 15
Material volume 150
Transport air gap 10
Hold time 3
Agitation Enabled
Aspiration number 2
LAS arm:
Air gap 50
Material volume 600

Enhanced Clean for LAS Probe

See Enhanced Clean for LAS Probe.
Description Enhance Clean for LAS Probe
Frequency As Needed
Air gap 50
Material volume 750
Hold time 3
Agitation Enabled
Aspiration number 2

Enhanced Clean for Reagent 1 and Reagent 2 Probes

See Enhanced Clean for Reagent 1 and Reagent 2 Probes.
Description Enhanced Clean for Reagent 1 and Reagent 2 Probes
Frequency As Needed
Air gap 15
Material volume 150
Hold time 3
Agitation Enabled
Aspiration number 2

Enhanced Clean for Reagent 1 Probe

See Enhanced Clean for Reagent 1 Probe.
Description Enhanced Clean for Reagent 1 Probe
Frequency As Needed
Air gap 15
Material volume 150
Hold time 3
Agitation Enabled
Aspiration number 2

Enhanced Clean for Reagent 2 Probe

See Enhanced Clean for Reagent 2 Probe.
Description Enhanced Clean for Reagent 2 Probe
Frequency As Needed
Air gap 15
Material volume 150
Hold time 3
Agitation Enabled
Aspiration number 2

Enhanced Clean for Reagent Probe

See Enhanced Clean for Reagent Probe.
Description Enhanced Clean for Reagent Probe
Frequency Daily
Air gap 15
Material volume 150
Hold time 3
Agitation Enabled
Aspiration number 2
LAS arm:
Air gap 50
Material volume 600

Enhanced Clean for Sample Probe

See Enhanced Clean for Sample Probe.
Description Enhanced Clean for Sample Probe
Frequency As Needed
Air gap 15
Material volume 150
Hold time 3
Agitation Enabled
Aspiration number 2
Foot and Probe Inspection

See Foot and Probe Inspection.
Description Foot and Probe Inspection
Frequency As Needed

Replace CTS Filter and clean Clean Cup Area

See Replace CTS Filter and clean Clean Cup Area.
Description Replace CTS Filter and clean Clean Cup Area
Frequency N/A – TOP 700 (includes TOP Base)

N/A – TOP 700 LAS
5000 Piercings – TOP 300 CTS
5000 Piercings – TOP 500 CTS
5000 Piercings – TOP 700 CTS (includes TOP CTS)
Replace CTS Piercer

See Replace CTS Piercer.
Description Replace CTS Piercer
Frequency N/A – TOP 700 (includes TOP Base)

N/A – TOP 700 LAS
As Needed– TOP 300 CTS
As Needed – TOP 500 CTS
As Needed– TOP 700 CTS (includes TOP CTS)
Replace LAS Syringe

See Replace LAS Syringe.
Description Replace LAS Syringe
Frequency As Needed

Replace LAS Syringe Tip

See Replace LAS Syringe Tip.
Description Replace LAS Syringe Tip
Frequency Every 6 Months
Replace Reagent 1 and Reagent 2 Syringe Tips

See Replace Reagent 1 and Reagent 2 Syringe Tips.
Description Replace Reagent 1 and Reagent 2 Syringe Tips
Replace Reagent 1 Syringe

See Replace Reagent 1 Syringe.
Description Replace Reagent 1 Syringe
Frequency As Needed
Replace Reagent 1 Syringe Tip

See Replace Reagent 1 Syringe Tip.
Description Replace Reagent 1 Syringe Tip

Replace Reagent 2 Syringe

See Replace Reagent 2 Syringe.
Description Replace Reagent 2 Syringe
Frequency As Needed
Replace Reagent 2 Syringe Tip

See Replace Reagent 2 Syringe Tip.
Description Replace Reagent 2 Syringe Tip
Replace Reagent Syringe

See Replace Reagent Syringe.
Description Replace Reagent Syringe
Frequency As Needed
Replace Reagent Syringe Tip

See Replace Reagent Syringe Tip.
Description Replace Reagent Syringe Tip

Replace Sample Syringe

See Replace Sample Syringe.
Description Replace Sample Syringe
Frequency As Needed
Replace Sample Syringe Tip

See Replace Sample Syringe Tip.
Description Replace Sample Syringe Tip
Frequency Every 6 months
Rinse/Clean Priming Cycle for All Probes

See Rinse/Clean Priming Cycle for All Probes.
Description Rinse/Clean Priming Cycle for All Probes
Frequency As Needed

Rinse/Clean Priming Cycle for LAS Probe

See Rinse/Clean Priming Cycle for LAS Probe.
Description Rinse/Clean Priming Cycle for LAS Probe
Frequency As Needed
Rinse/Clean Priming Cycle for Reagent 1 Probe

See Rinse/Clean Priming Cycle for Reagent 1 Probe.
Description Rinse/Clean Priming Cycle for Reagent 1 Probe
Frequency As Needed
Rinse/Clean Priming Cycle for Reagent 2 Probe

See Rinse/Clean Priming Cycle for Reagent 2 Probe.
Description Rinse/Clean Priming Cycle for Reagent 2 Probe
Frequency As Needed

Rinse/Clean Priming Cycle for Reagent Probe

See Rinse/Clean Priming Cycle for Reagent Probe.
Description Rinse/Clean Priming Cycle for Reagent

Probe
Frequency As Needed
Rinse/Clean Priming Cycle for Sample Probe

See Rinse/Clean Priming Cycle for Sample Probe.
Description Rinse/Clean Priming Cycle for Sample Probe
Frequency As Needed

Routine Clean for All Probes

See Routine Clean for All Probes.
Description Routine Clean for All Probes
Frequency As Needed
Air gap 15
Material volume 130
Hold time 0
Agitation Disabled
Aspiration number 1
LAS arm:
Air gap 50
Material volume 750
Wipe Down All Probes

See Wipe Down All Probes.
Description Wipe Down All Probes
Frequency As Needed
Wipe Down LAS Probe

See Wipe Down LAS Probe.
Description Wipe Down LAS Probe
Frequency As Needed

Wipe Down Reagent Probes

See Wipe Down Reagent Probes.
Description Wipe Down Reagent Probes
Frequency As Needed
Wipe Down Sample Probe

See Wipe Down Sample Probe.
Description Wipe Down Sample Probe
Frequency Weekly
* When you open the cover to perform a maintenance activity, tracking information for the on-board mate-
rials is maintained for one hour, as long as you remove the racks before you open the cover. The maintenance
activity must finish and the racks re-inserted into the instrument within one hour to maintain the tracking of
on-board materials.
See Also
l Maintenance List

Performing Maintenance Activities
NOTE:
l Always wear personal protective equipment (PPE) when performing maintenance cleaning activities.
l Any maintenance activity that requires the opening of the covers automatically invokes a system
recovery when the activity is finished and the covers are closed.
l When you open the cover to perform a maintenance activity, tracking information for the on-board
materials is maintained for one hour, as long as you remove the racks before you open the cover. The
maintenance activity must finish and the racks re-inserted into the instrument within one hour to main-
tain the tracking of on-board materials..
l You cannot leave the maintenance functional area or log out while a maintenance activity is in prog-
ress.
l Some maintenance activities can be performed individually or as a group activity. For example, if you
individually perform the Rinse/Clean Priming Cycle for the Reagent 1 Probe, the Reagent 2 Probe
and the Sample Probe, each activity's frequency status updates, but the frequency status for the group
activity Rinse/Clean Priming Cycle for All Probes does not update. However, if the group activity is
performed, the status of the group activity and all the included individual activities are updated.
l When moving the probe arm manually, lift it to its highest position to prevent damage during the
move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from the
front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
See Also
Maintenance Activities (listed alphabetically)
Automatic Fluidic Line Priming Cycle

This is performed automatically by the instrument. You cannot perform this manually.
NOTE: A Rinse Flow Verification Test is automatically performed by the instrument at the end of
Fluidic Line Priming. However, it will not start if the cuvette loader is empty, or if there is a rinse bottle
low warning or empty error. If a probe fails this test (each probe can retry 1 additional time), a Rinse Flow
Test Failure message displays.

Automatic Routine Clean for all Probes

This is performed automatically by the instrument. You cannot perform this manually.
NOTE: A Rinse Flow Verification Test is automatically performed by the instrument at the end of
Fluidic Line Priming. However, it will not start if the cuvette loader is empty, or if there is a rinse bottle
low warning or empty error. If a probe fails this test (each probe can retry 1 additional time), a Rinse Flow
Test Failure message displays.
Clean Cuvette Waste Drawer – Weekly (Manual Activity)

2. In the Maintenance screen, select1 the activity to run.
3. Select the Perform icon in the toolbar, or select Actions > Activity > Perform in the menu
bar.
4. A message prompts you to Perform the maintenance work first, and then press OK.
5. Remove the cuvette waste drawer.
6. Remove the liner from the cuvette waste drawer, clean it with 10% bleach or other laboratory
approved antimicrobial cleanser and replace it in the drawer; or replace the used liner with a new one.
7. Replace the cuvette drawer.
8. Select OK.
9. At the completion of the activity, the Maintenance Activity Execution dialog box opens where you
can enter a comment. Select OK to save the comment or Cancel to close the box without comment.

NOTE: If you periodically decontaminate the waste container using a bleach solution, rinse it suf-
ficiently with tap water afterwards to remove excess bleach residue. The capacitance liquid level sensor may
occasionally detect the residual bleach on the inner wall of the container and cause a false Waste Full trip on
the sensor. The false trip disappears within a few minutes. Rinsing the container with water removes the false
trip.
one object.

Clean Deep Wash and Clean Cup Area – Weekly (Manual Activity)
CAUTION: When moving the probe arm manually, lift it to its highest position to prevent damage
during the move. Grasp it from the back, as near the back wall as possible. Grasping a probe arm from
the front pushes it out of alignment. A misaligned probe arm prevents accurate coordinate adjustment and
other errors.
bar.
5. Open the appropriate cover as indicated by the message prompt.
6. Clean the deep wash and clean cup with a lint-free cotton swab, then rinse both areas with deionized
water to remove any debris. Leaving the filter in prevents loose debris from falling into unprotected
areas. Use the filter to collect debris around the clean area. Use a maximum of 10 mL of deionized
water; more than that may cause the accumulator to overflow.
7. Wipe excess deionized water that may have splashed onto the covers or the clean cup/deep wash area
with a lint-free cotton swab.
8. Close the covers and select the OK button on the window.
one object.

Clean Rack Areas – As Needed (Manual Activity)
NOTE: When you open the cover to perform a maintenance activity, tracking information for the on-
board materials is maintained for one hour, as long as you remove the racks before you open the cover. The
maintenance activity must finish and the racks re-inserted into the instrument within one hour to maintain the
tracking of on-board materials.
bar.
5. Remove the racks from the sample and reagent areas.
6. Open the covers.
7. Remove the clear plastic cover plate in the reagent area.
8. Clean the rack areas using a 10% bleach solution or Cavicide®.
9. Replace the cover plate.
one object.

CTS Foot Cleaning – As Needed (Manual Activity) – CTS Models Only
NOTE: When selected, the CTS arm needs to move over the clean cup. It may be there already.
bar.
4. A message prompts you to Open the sample area cover, perform the maintenance work, close the cov-
ers once again and press OK. When you see this message, open the cover.
WARNING Piercing Hazard: The piercer probe assembly is very sharp. When lifting the
foot, DO NOT place fingers in the area marked with a RED X shown in the following picture.
5. Clean the CTS foot with a lint-free swab soaked in deionized water.
6. Clean the clean cup area with a maximum of 10 mL of deionized water. Do not apply a stream of
deionized water to the foot and probe assembly, as splashing or spilling may cause water to leak into
the instrument. Be careful not to cause the clean cup (accumulator) to overflow.
7. Close the cover and click OK.
8. <Optional> Enter a comment in the field provided and click OK.
one object.

Cuvette Evacuation Cycle – As Needed (Semi-automatic Activity)

bar.
4. The system moves all cuvettes currently on the system, except those in the loader transport area, to the
cuvette waste area where they are dumped into the cuvette waste drawer.
Empty Cuvette Waste – Daily (Manual Activity) – 300 CTS Models Only
bar.
5. Remove the cuvette waste container and discard the contents into biohazard waste.
6. Replace the cuvette waste container.
NOTE: The cuvette waste container may be cleaned periodically with 10% bleach or other
laboratory approved antimicrobial cleanser, or replaced with a new container. Used containers should
be discarded in biohazard waste.

NOTE: You should periodically decontaminate the waste container shelf using a 10% bleach solu-
tion or other laboratory approved antimicrobial cleanser.
one object.
one object.

Empty Waste Fluid– Weekly (Manual Activity) – 300 CTS Models Only
bar.
5. Disconnect the waste tank and dispose of its contents in a manner consistent with local regulations.
6. Reconnect the waste tank.
NOTE: You can disconnect the liquid waste line while the system is running; however, you
must replace the liquid waste line within 5 minutes, or the system perform an emergency stop.
CAUTION Biohazard: Liquid waste is biohazardous. Use precautions when emptying the

waste tank.
NOTE: You may periodically decontaminate the waste tank using a 10% bleach solution or other lab-
oratory approved antimicrobial cleanser.
one object.

Enhanced Clean for All Probes – Daily for all probes together (Semi-
automatic Activity)
NOTE:
l If an emergency stop was performed by the system because of a lack of system clean, an error message
opens, and you must run the Enhanced Clean activity on the specific probe.
l For users performing more than 50 thrombin-based or Factor Xa-based tests (Antithrombin, Clauss
Fibrinogen, or Thrombin Time) per day, it is strongly recommended that the Enhanced Clean be per-
formed on all probes once per shift. For users running fewer than 50 thrombin-based or Factor Xa-
based tests per day, the Enhanced Clean should be performed once per day.
l Clean B is corrosive. Remove it from the instrument after the maintenance activity that requires it is
complete.
1. Place a full 10 mL bottle of Clean B on the appropriate reagent rack as indicated in the following
table:
Model No. of Track Positions Covers to Open

Clean B Bottles
TOP 300 CTS 1 D1 None
TOP 500 CTS 2 D1 None
R3
TOP 700 (includes TOP Base) 3 D1, D2 None
D3, R1, R2
R5, R6
TOP 700 CTS (includes TOP CTS) 3 D1, D2 None
D3, R1, R2
R5, R6
TOP 700 LAS 4 D1, D2 LAS
D3, R1, R2
R5, R6
LAS Aspiration Point

bar.
5. <TOP 700 LAS only> Place Clean B reagent in a 20 mL vial.
one object.

NOTE: The LAS cover is manually operated, but if the LAS cover is opened during normal
activities, an emergency stop is performed by the instrument. In the case of this enhanced clean, the
cover can be opened without invoking an emergency stop.
6. The enhanced clean for all the probes is performed by the instrument.
7. At the completion of the enhanced clean, a message prompts you to remove the Clean B vial from the
LAS cover aspiration point. Select OK. The Maintenance Activity Execution box opens where you
8. Remove all the remaining bottles of Clean B when the activity is finished.

Enhanced Clean for LAS Probe – As Needed (Semi-automatic Activity)

– LAS Models Only
NOTE:
complete.
bar.
4. A message prompts you to Place a 20 mL vial containing Clean B in the LAS cover aspiration point
and close the cover.
5. Open the LAS arm cover and place the Clean B.
6. Close the cover. Select OK.
NOTE: The LAS cover is manually operated, but if the LAS cover is opened during normal
activities, an emergency stop is performed by the instrument. In the case of this enhanced clean, the
cover can be opened without invoking an emergency stop.
7. At the completion of the enhanced clean, a message prompts you to remove the Clean B vial from the
LAS cover aspiration point. Select OK. The Maintenance Activity Execution box opens where you
one object.

Enhanced Clean for Reagent 1 and Reagent 2 Probes – As Needed

(Semi-automatic Activity) – TOP 700 Models Only
NOTE: If you select both Enhanced Clean for Sample Probe and Enhanced Clean for Reagent 1 and
Reagent 2 Probes individually, you cannot run them both at the same time. You must initiate one activity
and wait until it is completed before initiating the second.
NOTE:
complete.
1. Place a full 10 mL bottle of Clean B on a reagent rack and place the rack into track D3, R1 or R2,
and R5 or R6. Identify the material as Clean B.
bar.
5. The enhanced clean for the reagent probes is performed by the instrument.
7. Remove the bottle of Clean B when the activity is finished.
one object.

Enhanced Clean for Reagent 1 Probe – As Needed (Semi-automatic

Activity)
NOTE:
complete.
table:
Model Track Positions

TOP 300 CTS D1
TOP 500 CTS R3
TOP 700 (includes TOP Base) D3, R1, R2
TOP 700 CTS (includes TOP CTS) D3, R1, R2
TOP 700 LAS D3, R1, R2

bar.
5. The enhanced clean for reagent 1 probe is performed by the instrument.
one object.

Enhanced Clean for Reagent 2 Probe – As Needed (Semi-automatic

Activity) – TOP 700 Models Only
NOTE:
complete.
1. Place a full 10 mL bottle of Clean B on a reagent rack and place the rack into track R5 or R6. Identify
the material as Clean B.
bar.
one object.

Enhanced Clean for Reagent Probe – As Needed (Semi-automatic

Activity) – 300/500 CTS Models Only
NOTE:
complete.
table:

TOP 300 CTS D1
TOP 500 CTS R3

bar.
one object.

Enhanced Clean for Sample Probe – Daily (Semi-automatic Activity)
NOTE:
complete.
table:

TOP 300 CTS D1
TOP 500 CTS D1
TOP 700 (includes TOP Base) D1, D2
TOP 700 CTS (includes TOP CTS) D1, D2
TOP 700 LAS D1, D2

bar.
5. The enhanced clean for the sample probe is performed by the instrument.
one object.

Foot and Probe Inspection – As Needed (Manual) – CTS Models Only
bar.
4. A message prompts you to Open the sample area cover, perform the maintenance work, close the
cover once again and press OK. When you see this message, open the cover.
5. Inspect the CTS foot and probe by lifting up the left side of the CTS foot. (The foot is the white com-
ponent in the following picture.)
WARNING Piercing Hazard: The piercer probe assembly is very sharp. When lifting the
foot, DO NOT place fingers in the area marked with a RED X shown in the following picture.
NOTE: The frequency counter for Clean CTS Deep Wash Station and Clean Cup is not reset
after performing this activity.
6. Close the cover and click OK.
one object.

Replace CTS Filter and clean Clean Cup Area – 5000 Piercings (Manual
Activity) – CTS Models Only
other errors.
bar.
4. A message prompts you to Open the sample and reagent area covers, perform the maintenance work,
close the covers once again and press OK.
5. Open the sample area cover. (Open main cover for TOP 300 CTS and TOP 500 CTS models.
6. Clean the deep wash and clean cup with a lint-free cotton swab, then rinse both areas with deionized
water to remove any debris before removing the filter to prevent loose debris from falling into unpro-
tected areas. Use the filter to collect debris around the clean area. Use a maximum of 10 mL of deion-
ized water; more than that may cause the accumulator to overflow.
7. Wipe excess deionized water that may have splashed onto the covers or the clean cup/deep wash area
with a lint-free cotton swab.
8. Inspect the new filter to ensure there are no rips in the filter material.
one object.

9. Insert the CTS filter replacement tool provided into the filter in the probe's deep wash location on the
left of the rinse/clean cup. Lightly push down on the top of the tool to allow it to grab the filter.
Remove the filter from the deep wash and replace it with a clean filter, again using the tool to seat the
filter. (If you push hard on the top of the tool you apply greater pressure, making it more difficult to
remove the filter.)
CAUTION Biohazard: The CTS filter is disposable and should be thrown away after
one use. Used CTS filters are biohazardous. Use precautions when disposing of the used filter.
10. Close the sample area cover and select OK to display a comment window.
11. Select OK to close the comment window.
Replace CTS Piercer – Every 120,000 piercings (Manual Activity) – CTS

Models Only
l See Replace CTS Piercer/Probe Procedure.
WARNING Piercing Hazard: Discard the used piercer into a sharps container.
Replace LAS Syringe – As Needed (Semi-automatic Activity)

l See Replacing the Syringe and Syringe Tip.
Replace LAS Syringe Tip – Every 6 months (Semi-automatic Activity)

Replace Reagent 1 and Reagent 2 Syringe Tips – Every 6 months

(Semi-automatic Activity)
Replace Reagent 1 Syringe – As Needed (Semi-automatic Activity)

Replace Reagent 1 Syringe Tip – Every 6 months (Semi-automatic

Activity)

Replace Reagent 2 Syringe – As Needed (Semi-automatic Activity)

Replace Reagent 2 Syringe Tip – Every 6 months (Semi-automatic

Activity)
Replace Reagent Syringe – As Needed (Semi-automatic Activity)

Replace Reagent Syringe Tip – Every 6 months (Semi-automatic Activ-

ity)
Replace Sample Syringe – As Needed (Semi-automatic Activity)

Replace Sample Syringe Tip – Every 6 months (Semi-automatic Activ-

ity)
Rinse/Clean Priming Cycle for All Probes – As Needed (Semi-auto-

matic Activity)
bar.
one object.

Rinse/Clean Priming Cycle for LAS Probe – As Needed (Semi-auto-

matic Activity)
bar.
one object.

Rinse/Clean Priming Cycle for Reagent 1 Probe – As Needed (Semi-

automatic Activity)
bar.
4. The rinse/clean priming cycle is performed by the instrument.
Rinse/Clean Priming Cycle for Reagent 2 Probe – As Needed (Semi-

automatic Activity)
bar.
one object.
one object.

Rinse/Clean Priming Cycle for Reagent Probe – As Needed (Semi-auto-

matic Activity)
bar.
Rinse/Clean Priming Cycle for Sample Probe – As Needed (Semi-auto-

matic Activity)
bar.
one object.
one object.

Routine Clean for All Probes – As Needed (Semi-automatic Activity)
NOTE: Instrumentation Laboratory recommends performing a routine clean once per shift. This rec-
ommendation is based on 1200 clotting tests (such as PT and APTT) per shift. The frequency of cleaning may
vary depending upon the types of tests being routinely performed. Tests such as Antithrombin, Clauss Fibri-
nogen, or Thrombin Time may require additional cleaning frequency. See the Enhanced Clean procedures,
above.
bar.
4. The routine clean for all probes is performed by the instrument.
one object.

Wipe Down All Probes – As Needed (Manual Activity) – Non-CTS Mod-

els Only
other errors.
bar.
4. A message prompts you to open the appropriate cover(s). Select OK.
5. Open the covers indicated by the message prompt.
NOTE: When you open the cover to perform a maintenance activity, tracking information for
the on-board materials is maintained for one hour, as long as you remove the racks before you open
the cover. The maintenance activity must finish and the racks re-inserted into the instrument within
one hour to maintain the tracking of on-board materials.
6. Using an alcohol pad, wipe clean the probes' exteriors and tips.
7. Close the covers.
8. Select OK on the screen.
one object.

Wipe Down LAS Probe – Weekly (Manual Activity)
other errors.
bar.
4. A message prompts you to Open the Sample area cover, perform the maintenance work, close the
cover once again and press OK.
5. Open the Sample area cover.
6. Using an alcohol pad, wipe clean the probe's exterior and tip.
7. Close the cover.
one object.

Wipe Down Reagent Probes – As Needed (Manual Activity)
other errors.
bar.
4. A Maintenance Activity Execution window opens.
5. Select the OK to unlock the covers.
6. Open the Reagent side or Main cover.
7. Using an alcohol pad, wipe clean the reagent probe exteriors and tips.
8. Close the cover.
one object.

Wipe Down Sample Probe – Weekly (Manual Activity) – Non-CTS

instruments Only
other errors.
bar.
4. A message prompts you to open the appropriate cover. Select OK.
5. Open the Sample area or Main cover.
6. Using an alcohol pad, wipe clean the probe's exterior and tip.
7. Close the cover.
8. Select OK on the screen.
See Also
l Maintenance List
l System Decontamination
one object.

Replacing the Syringe and Syringe Tip

Replacing the syringe tip is an Every 6 Months, Semi-automatic activity.
CAUTION: This procedure should be performed only by a properly trained technician.
Hamilton Syringe Procedures

Removing the Hamilton Syringe
Replacing the syringe is an As Needed, Semi-automatic activity.
other errors.
To remove the Hamilton syringe.
1. Select System > Maintenance in the menu bar to open the list of maintenance procedures.
2. Select1 the appropriate Replace <Arm> Syringe procedure in the Maintenance Activities List.
3. Select the Perform icon in the toolbar.

4. Follow instructions in the popup window to remove the sample or reagent racks, and click OK.
5. Open the access cover. The syringe plunger moves down approximately 1 cm from the initialized posi-
tion to facilitate removal.
6. Loosen the thumbscrew securing the syringe collar, and remove the syringe collar.
7. Loosen the thumbscrew securing the plunger to the drive stem.
8. Unscrew the old syringe barrel from the valve fitting.
9. Remove the syringe.
H amilton Pump, Syringe and C ollar
one object.

Replacing the Hamilton Syringe Tip

To replace the Hamilton syringe tip:
1. <Optional> Remove the Hamilton syringe.
2. Make sure the syringe collar is removed. See Removing the Hamilton Syringe
3. Pull the metal plunger from the glass tube.
4. When initially inserting a new plunger into a GASTIGHT syringe barrel, wet (lubricate) the tip with
deionized water.
5. <Optional> Install the syringe tip by inserting the plunger with the pre-installed Teflon tip attached
into the syringe glass tube.
H amilton Pump, Syringe and C ollar
Installing the Hamilton Syringe

To install the Hamilton syringe:
1. Screw the syringe glass tube onto the syringe pump valve.
2. Manually lower the plunger so the metal knob at the bottom of the syringe plunger seals in the thumb
wheel block.
3. Tighten the thumb wheel until it is finger-tight.
4. Hand-tighten the syringe screw connection.
5. Slide the collar over the glass portion of the syringe.
6. Slide the collar up to the metal hub on the syringe.

7. Rotate the collar to the left until it contacts the front plate of the syringe pump. Then tighten the col-
lar thumb screw to secure the collar over the metal hub.
NOTE: Do not tighten collar thumb screw onto glass portion of the syringe.
8. Move the probes over the rinse/clean cup area.
9. Visually inspect the syringe and verify it is free from bubbles and leaks.
Removing the Cavro Syringe

Replacing the syringe is an As Needed, Semi-automatic activity.
other errors.
To remove the Cavro syringe:
1. Select System > Maintenance in the menu bar to open the list of maintenance procedures.
2. Select1 the appropriate Replace <Arm> Syringe procedure in the Maintenance Activities List.
3. Select the Perform icon in the toolbar.

4. A message prompts you to remove the appropriate racks. Remove the racks from the instrument and
select OK in the message window.
one object.

5. Another message prompts you to Remove the syringe and replace it. Close covers when finished and
press OK.
6. Open the access cover. The syringe plunger moves down approximately 1 cm from the initialized posi-
tion to facilitate removal.
7. To guard against leaking, carefully move the probe over its rinse station.
8. Completely loosen the thumbscrew from the plunger end.
9. Unscrew upper end of the syringe, push down and remove syringe assembly from pump.
C avro Pump and Syringe
Replacing the Cavro Syringe Tip

To replace the Cavro syringe tip:
1. Remove the metal plunger from the syringe glass cylinder.
2. Using pliers, pull the Teflon syringe tip from the metal plunger.
3. With the open side of the Teflon tip facing up, slide the Teflon tip into the ISE slot on the instal-
lation tool.

4. Place the rubber O-ring on the tip of the metal plunger.

5. Insert the end of the plunger with the rubber O-ring installed into the ISE slot of the installation tool.
Push the plunger in so the Teflon tip snaps onto the tip of the metal plunger.
6. Remove the plunger from the ISE slot and wipe it with reagent grade alcohol.
7. Insert the plunger with the Teflon tip attached into the glass syringe cylinder.
Installing the Cavro Syringe

To install the Cavro syringe:
1. Insert the upper end of the syringe glass cylinder into the pump valve and rotate until it is tight.
2. Pull the plunger down so the end sits in the channel of the plunger drive stem.
3. Hold the plunger and fully tighten the thumbscrew into the syringe.
4. Close the cover.
5. Select OK in the message window that prompted you to Remove the syringe and replace it.
6. The TOP reinitializes.
7. Verify during re-initialization that the syringe moves up and down correctly.
See Also
l CTS Piercer/Probe Replacement Procedure Overview

CTS Piercer/Probe Replacement Procedure Overview

The Closed Tube Sampling (CTS) piercer provides:
l Piercing and sampling of capped sample tubes for all CTS model in CTS mode
l Sampling only of uncapped sample tubes.
The piercer is a part of the sample arm and is not present on the Base TOP model. See Global Definitions
Setup for enabling CTS Mode.
The CTS Piercer has three components:
l Sample Probe and Seal Assembly – Located in the telescoping CTS assembly.
l CTS Piercer Probe – Consists of 1) the piercing probe that pierces the cap of a sample tube; and 2)
the sample probe inside the piercer probe that aspirates and dispenses sample material. The sample
probe is protected by the piercer probe during piercing.
l Telescoping CTS Assembly – All parts except the Sample Probe and Seal Assembly and the CTS
Piercer Probe are non-replaceable.
CTS Piercer/Probe Replacement Procedures

Each of the following procedures also contains a video clip:
l Probe and Seal Assembly Removal Procedure
l Probe and Seal Assembly Installation Procedure
l Piercer Probe Removal Procedure
l Piercer Probe Installation Procedure

Probe and Seal Assembly Removal Procedure

This is an As Needed, Manual activity
NOTE:
l The videos in this topic run as soon as they appear on the monitor.
l Select the Refresh button in the help viewer toolbar (or press the F5 key on the keyboard) to
start the video from the beginning. Click the Stop button to pause the video.
l It is not necessary to remove any of the internal covers to perform this procedure.
CAUTION Biohazard: Probes are Biohazardous. Use caution when removing and installing
them.
Removing the Probe and Seal Assembly

To remove the probe and seal assembly:
1. Select the Controllers, Covers and Racks tab from the Diagnostics screen.
2. Select the Unlock Sample Cover button (Cover button for 300 CTS and 500 CTS models).
3. Open the Sample cover on the instrument (cover for 300 CTS and 500 CTS models).
4. Power off the instrument by turning off the main power switch.
5. Placing a blue absorbent pad over the sample area can be of help in collecting small parts or droplets
during the procedure.
6. Manually move the CTS Piercer Arm into the sample area. Ensure that the piercer probe and the sam-
ple probe stay above the skins as the arm is moved.

CAUTION: When manually moving the probe arm, lift the arm to its highest position. To
avoid damaging the probe arm during the move, grasp it from the back, as near to the back wall as
possible. Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm
causes inaccurate coordinates adjustment and other errors.
7. Air Tube:
Disconnect the 1/4” air line from the front of the Probe and Seal Assembly.
Loosen the Tube Support Bracket screw by turning it counter-clockwise until the bracket can be
removed.
Remove the fluid line from the top of the Probe and Seal Assembly by sliding the sleeve back over
the tubing, then removing the tubing.

8. Gently pull on the connector to remove the Sampling Probe LLD cable from the front of the CTS Tel-
escoping Assembly.
9. Loosen the thumbscrew on the side of the Telescoping CTS Assembly by turning it counter-clock-
wise. The thumbscrew is spring loaded and pops out when loosened all the way. The Piercer/Probe
Hold Down Bracket that is attached to the thumbscrew should also pop outward enabling the removal
of the Probe and Seal assembly.

10. Push the Z-drive rack down so that it is just above the Sample Plate. (Push down on the top of the Z-
drive rack.)
11. Carefully pull the Probe and Seal assembly up and out of its mounting. Do not bend the sample probe
as the probe is pulled out of its mounting. (The Probe and Seal Assembly can be loosened by gently
rocking it.)
NOTE: To remove the sample probe without bending it, the Z-drive must first be pushed
down as far as possible. With the Z-drive in this position, the Robotic Arm is cleared when pulling
the sample probe out of its mounting.
See Also

Probe and Seal Assembly Installation Procedure

NOTE:
them.
Installing the Probe and Seal Assembly

To install the probe and seal assembly:
1. Ensure the main power switch for the instrument is turned off.
2. Push the Z-drive rack down so that it is just above the Sample Plate. (Push down on the top of the Z-
drive rack.)
NOTE: The Z-drive Rack must be down to insert the Probe and Seal Assembly without bend-
ing it.
3. Ensure the Probe and Seal Hold Down Bracket is not blocking the hole.
4. Insert the Probe and Seal Assembly in its mounting and gently push down on the Assembly until it
seats and the Probe and Seal Hold Down Bracket can be slid over its lip.
NOTE: Make sure the Telescoping CTS Assembly is held to prevent motion of the Assembly
as the Probe-n-Seal Assembly is seated. Otherwise, damage to the CTS Piercer Probe may occur.

5. Push the Piercer Probe Hold Down Bracket over the top lip of the Probe-n-Seal Assembly.
6. Tighten the thumbscrew on the side of the Telescoping CTS Assembly by turning it clockwise.
(Make the thumbscrew finger-tight.)
7. Connect the Sampling Probe LLD cable to the front of the Telescoping CTS Assembly.
8. Install the fluid line to the top of the Probe and Seal Assembly by sliding the fluid line over the steel
tube and sliding the sleeve over the end of the tubing.

l Reinstall the Tube Support Bracket and tighten the screw by turning it clockwise until
the bracket is tight.
l Connect the 1/4” air line to the front of the Probe and Seal Assembly.
9. It is recommended the system be powered up and the Piercer Loop Test be executed with a count of
50 as found in Piercer Loop Test on the CTS tab screen in Diagnostics.
See Also

Piercer Probe Removal Procedure

NOTE:
them.
Removing the Piercer Probe

To remove the piercer probe:
1. Select the Controllers, Covers and Racks tab from the Diagnostics screen.
2. Select the Unlock Sample Cover button (Cover button for 300 CTS and 500 CTS models).
3. Open the Sample cover on the instrument (cover for 300 CTS and 500 CTS models).
4. Power off the instrument by turning off the main power switch.
5. Remove the Probe and Seal Assembly as described in Probe and Seal Assembly Removal Procedure.
6. Raise the Telescoping CTS Assembly as high as necessary to access the knurled nut on the bottom of
the Piercer.
7. Loosen the knurled nut by turning it counter-clockwise. (Pliers may be needed to do this.) Loosen the
nut until it falls into the foot.

Piercer Probe Removal Procedure
8. Push the Z-drive rack down until the Foot is just above the Sample Plate. (Push down on the top of
the Z-drive rack.)
9. Push and hold in the CTS Piercer Lock on the right-hand side of the Telescoping CTS Assembly to
release pressure on the piercer probe.
10. While holding the CTS Piercer Lock in, remove the piercer probe by pulling up on the probe top. Do
not use tools to pull out the piercer probe. It may be necessary to twist and move the probe back and
forth to remove it.
CAUTION Biohazard: The piercer probe is sharp and may cause serious injury if it is
improperly handled. Dispose of used piercer probes in a “Sharps” container.
See Also

Piercer Probe Installation Procedure

NOTE:
them.
Installing the Piercer Probe

To install the piercer probe:
1. Ensure the main power switch for the instrument is turned off.
2. Push in the CTS Piercer Lock on the side of the Telescoping CTS Assembly, and hold it all the way
to the back.
3. Remove the vinyl protective tip from the new piercer.
NOTE: Failure to remove the vinyl tip from the piercer may result in the sample probe jam-
ming.
4. While holding in the CTS Piercer Lock, guide the piercer probe into its mounting.
NOTE: As the piercer probe is inserted into its mounting, the flat side of the piercer probe
threads must face the front of the instrument. This is required for proper seating of the probe.

Piercer Probe Installation Procedure
5. Push down on the piercer probe until it locks into the “down” position.
6. Apply a drop of Loctite #222 (Low Strength), available in the installation kit, to the thread on the top
of the piercer probe.
CAUTION: Failure to follow this step may result in a malfunction.
7. Re-fasten the piercer probe knurled nut, ensuring the nut is tight.
8. Install the Probe and Seal Assembly as described in Probe and Seal Assembly Installation Procedure.
9. After the Probe and Seal Assembly is installed, it is recommended the system be powered up and the
Piercer loop test be executed with a count of 50 as found in Piercer Loop Test on the CTS tab screen
in Diagnostics.
See Also

Warning Thresholds
Configuring Maintenance Activity Warning Thresholds
To configure a warning threshold for a maintenance activity:
3. In the Maintenance Activity List, select1 the maintenance activity for which to set a warning thresh-
old.
4. Select the Warning Threshold icon in the toolbar, or select Actions > Configuration > Warn-
ing Thresholds in the menu bar.
5. In the Maintenance Warning Threshold Configuration dialog box, configure the required warning
thresholds.
6. Select OK.
Maintenance Warning Threshold Configuration dialog box
one object.

Warning Thresholds
Configure the warning threshold for each frequency type in the Maintenance Warning Threshold Con-
figuration dialog box. When the defined interval elapses, a warning appears before the scheduled activity is
to occur. In the example above, a warning appears eight hours before a daily activity is scheduled to occur.
As Needed activities do not have warning thresholds.
See Also
l Maintenance List

System Decontamination
ACL TOP Instrument Decontamination is an As Needed activity.
To decontaminate the ACL TOP instrument:
1. Perform the Enhanced Clean for each probe using Clean B (BGE/ACL Cleaning Agent). See Parts and
Consumables List.
2. Clean the optical window in the LAS, Sample, and Reagent access doors using only a mild cleaning
agent and soft cloth to prevent scratching and damage to the windows’ surface.
3. For the following steps, use a decontaminant such as Cavicide® or 10% bleach solution.
4. Manually remove all cuvettes, racks, samples, reagents and any other vials from the instrument. Wipe
down all inside and exposed module surfaces, including the LAS, sample, and reagent modules and
loader. Clean all racks using Cavicide® or 10% bleach solution and rinse with deionized water.
NOTE: Do not use alcohol to clean the racks. The alcohol degrades the bar code labels so
they are unreadable by the bar code reader.
5. Empty and decontaminate the cuvette waste drawer. Replace the drawer liner with a new one or
decontaminate or autoclave the liner and return to the waste drawer.
CAUTION Biohazard: Cuvettes waste is biohazardous. Use precautions when emp-

tying the cuvette waste drawer. Refer to local and state regulations for disposal of potentially haz-
ardous materials.
6. Decontaminate all external surfaces, including the table and instrument back cover.
7. Decontaminate the rinse and clean bottle stations.
8. Decontaminate the waste container and the outside of the waste line and its connectors.
CAUTION Biohazard: System fluid waste is biohazardous. Use precautions when

changing or emptying the fluid waste container.
9. Close out of the application and shut down the computer. (See Shutting Down the Instrument.) Turn
off power to the monitor, keyboard, and instrument. Decontaminate the computer, monitor, and key-
board including any power cords, using a cloth moistened with 10% bleach or Cavicide®.
NOTE: Only IL representatives should shut down, decontaminate and prepare the instrument
for transportation. The Decontamination Form issued by Instrumentation Laboratory accompanies the
system and must be signed by the Service representative.
See Also

Cleaning the Monitor
Cleaning the Monitor
WARNING: To avoid risk of electric shock, do not disassemble the power converter or display unit
cabinet. The unit is not user serviceable. If liquid does get inside the monitor, have a qualified service tech-
nician check it before turning it on again.
This is an As Needed activity.
To clean the touch screen monitor:
1. Unplug the monitor from the power source.
2. Put some window or glass cleaner on a cleaning cloth and wipe the touch screen. Do not apply the
cleaner directly to the touch screen. Do not wipe the screen with a cloth or sponge that could scratch
the surface.
3. To clean the display unit cabinet, use a cloth lightly dampened with a mild detergent. Do not use
alcohol (methyl, ethyl or isopropyl) or any strong dissolvent. Do not use thinner or benzene, abrasive
cleaners or compressed air.

Cleaning the Reagent Cooling Filter

Cleaning the reagent cooling filter is a Manual activity.
The filter is replaced during routine service every 6 months. However, it may be necessary to clean the filter
before it is replaced, depending on the lab setting.
To clean the reagent cooling filter:
1. Locate the filter under the Reagent Area of the instrument.
2. Remove the filter by sliding it forward.
3. Pass the filter under running water to remove the debris.
4. Allow the filter to dry completely.
5. Install the dry filter on the instrument.
NOTE: It is recommended that an alternate filter be used to replace the newly washed filter until the
washed filter is dry. The alternate filter can then be used for the next replacement.

Diagnostics Overview
Diagnostics Overview
Diagnostics is intended to be used by the Lab Administrator for Probes/Coordinates Adjustment, and ORU
blanking.
CAUTION:
l Contact an IL Service Representative before using any functionality other than probe alignment or
ORU blanking in Diagnostics. If necessary the service representative will walk you through the diag-
nostic procedure step by step.
l Diagnostics is part of ordinary maintenance. The lab administrator is responsible for ensuring that
those who are not trained in diagnostic procedures are prevented from accessing the Diagnostics
screens. See Software Access Screen.
Accessing the Diagnostic Area

To access the Diagnostics area:
1. Make sure the instrument is in the Ready or Error state.
2. Select System > Diagnostics in the menu bar.
The system performs an emergency stop when exiting the Diagnostics area. While in Diagnostics, the system
does not perform most of the error-generated automatic emergency stops.
Diagnostics Screen
The following tabs appear in the Diagnostics screen. Certain tabs may be disabled depending on the ACL
TOP model.
l Cuvettes
l ORU
l ORU Linearity Test
l Controllers, Covers and Racks
l Fluids
l Probes
l Voltages
l CTS
l Universal Arm
l Fluid Precision Test
See Also
l Probes/Coordinates Adjustment
l ORU blanking

Cuvettes
Viewing the Cuvettes Screen

To view the Cuvettes screen:
2. Select the Cuvettes tab.
Cuvettes Tab
See Also
l Diagnostics Overview

ORU Blanking Procedure
NOTE: If you perform an action on the ORU screen before the optical reading units are at the proper
operating temperature, the action will not occur. A message displays: Blanking is not available until the
ORUs have reached operating temperature.
2. Select the ORU tab.
3. Verify that all four ORUs are enabled.
l Green is enabled.
l Red is disabled.
4. To re-enable an ORU place a check mark in the box next to it and select the Save button.
5. Select the Start Air Blanking for All ORUs button.
6. After approximately four minutes, the Activity Results window opens. It contains the following infor-
mation:
l Current Maintenance Activity Results

l Previous Values Stored in Database
l Air blanking values for both the 405 and 671 wavelengths. The minimum value for the
current air blanking is 500,000. The maximum value is 1,200,000.
l % Drift – The limit for drift from the previous to the current is 6%.
7. If all specifications are met, select the Overwrite button. If specifications are not met, select the Can-
cel button and call for Service.
8. Select the Start Factor Diluent Blanking for all ORUs button. The CM asks for a 10 mL bottle of
Factor Diluent to be placed on board. Ensure the bottle is full to the top. This procedure takes about
30 minutes.
NOTE: All mechanical assemblies must be initialized or the blanking fails. In addition,
cuvettes, rinse, and Clean A (the regular on-board clean) must be on-board.
9. The Activity Results window opens again. Apply the same specifications. If they all pass, select Over-
write. Otherwise select Cancel and call Service.
10. Exit Diagnostics.

ORU Cleaning Procedure

2. Select the Controllers, Covers and Racks tab.
3. In the Cover status section, select Reagent area and select Unlock.
4. Using clean dry cotton applicators carefully wipe an ORU cuvette slot from front to rear.
5. Inspect the applicator for dirt or foreign substances and repeat until the slot is clean.
6. Repeat for each ORU.
7. When finished, close the cover.
ORU Tab
ORU Blanking area

Each ORU may be manually disabled by unchecking the box next to it and selecting the Save button. The
ORU is automatically disabled when one of the following conditions is detected for any of its four channels:
l The current air reading is lower than 500,000.
l The current air reading is higher than 1,200,000.
l The difference between the current air reading and the stored air reading is greater than 6%.
l A detector voltage error is reported by the ORU.
NOTE: Any error that causes the automatic disabling of an ORU must be corrected before the ORU
can be re-enabled.

After the error is corrected, place a check mark in the box next to the ORU and select the Save button. Per-
form the ORU cleaning procedure followed by the ORU blanking procedure.
Temperatures area
The current temperature and the lower and upper limits are displayed for each ORU head and incubator.
Reference Readings area

The reference channel readings come from one ORU. The reference readings are used with the analytical chan-
nels.
For each wavelength the following values are displayed for the DAC:
l Minimum DAC value (Min. DAC)
l Maximum DAC value (Max. DAC)
Dark Readings Area

The dark reading is the reading of the analytical channel without the emitter. This value depends on the elec-
tronics (dark current) and stray light.
The upper dark limit, valid for all the channels and all the ORUs and displayed as “Limit”, is displayed for
reference.
See Also
l Wavelength Definition

ORU Linearity Test

Viewing the ORU Linearity Test Screen

To view the ORU Linearity Test screen:
2. Select the ORU Linearity Test tab.
ORU Linearity Test Tab
See Also
l Optical Reading Unit

Controllers, Covers and Racks
Controllers, Covers and Racks
Viewing the Controllers, Covers and Racks Screen

To view the Controllers, Covers and Racks screen:
2. Select the Controllers, Covers and Racks tab.
Controllers, Covers and Racks Tab

Reagent block temperature
This tab displays the reagent block actual temperature, reagent block lower limit, and reagent block upper
limit.
See Also

Fluids
Viewing the Fluids Screen

To view the Fluids screen:
2. Select the Fluids tab.
Fluids Tab
See Also

Probes/Coordinates Adjustment
Accessing the Probes tab

To open the Probes tab:
2. Select the Probes tab.
3. <Optional> Select a button (Initialize All Probes, Home All Probes, etc.) to perform the associated
task.
Preparing for Adjusting Probe Coordinates

Before adjusting probe coordinates perform the following steps:
1. Initialize the bar code reader. Contact service.
2. Disable the arm. Select the respective Disable <Arm> Probe button in the Diagnostics Probe tab.
3. Unlock the Sample Area and Reagent Area covers, and remove all interior covers in the Sample and
Reagent Areas.
4. Clean the following components thoroughly using alcohol swabs with 70% isopropyl alcohol by vol-
ume (the coordinate adjustment fails if you omit this step):
l Probe tips
l Waste station deck, rim and cup (see: Figure 3).
l Screws on sample plate/diluent plate
l Screws on reagent plate
l Screws on the incubators and ORUs (see: Figure 1)
l Screws in the LAS area.
NOTE: Clean all parts of the screws including the top, the edges, the side, and inside
the hole in the screw head, where appropriate. See: Figure 2.

Figure 1. Screw Locations on the Incubators and ORUs
Figure 2. Types of Screws Used

Figure 3. Waste well area
Figure 4. Screw locations for LAS probe
CAUTION: This procedure should only be performed by individuals who have been properly
trained.
NOTE:
l Failure to disable the arms can result in the arms crashing into the waste well.
l If there are racks in the modules, or the bar code reader is not in the home position, this operation can-
not be performed. If the operation can be performed, the bar code reader cannot be moved by either
the AM or CM track buttons until the operation is finished.

Adjusting Probe Coordinates

The adjustment is performed for each probe individually when the arm status for that probe is Ready. This
procedure is performed when the probe needs to be adjusted for the first time, or after mechanical repair.
To adjust probe coordinates:
1. Perform all the steps in the Preparing for Adjusting Probe Coordinates procedure.
2. Bring the arm to READY status.
3. Open the Diagnostics Probes tab.
4. Select the probe to adjust in the Probe drop-down list.
5. Select the Start button in the Coordinate Adjust section on the Probes tab.
Setting the LAS Aspiration Point Manually

To manually set the LAS aspiration point:
2. Select the Disable LAS arm button on the Probes tab.
3. Select the LAS probe to adjust in the Probe drop-down list.
4. Select the Set LAS aspiration point button on the Probes tab.
5. Open the LAS cover.
6. Place a sample tube onto a rack on the LAS track and position the tube directly below the LAS probe.
7. When prompted by the system, manually raise the LAS probe to the liquid level detection start posi-
tion. Move the probe tip down to approximately 1 inch below the top of the sample tube and center it
within the tube.
8. Select OK.
9. When prompted by the system, manually lower the LAS probe to the maximum reachable position in
the sample tube. Move the probe down until it touches the bottom of the sample tube, then move it
slightly higher.
10. Select OK.
11. A window displays with the coordinates for the LAS probe. If the values are correct select OK, or
select Cancel.
12. A warning appears stating: The arm is going to move back into the instrument. Select OK to return
the arm to its home position.
13. Close the LAS cover.

Setting the LAS Aspiration Point Semi-Automatically

This procedure uses a tool located inside the cover of the LAS arm.
To set the LAS aspiration point semi-automatically:
2. Select Disable LAS arm on the Probes tab.
3. Select the LAS probe to adjust in the Probe drop-down list.
4. Select the Measure LAS aspiration point button on the Probes tab.
5. The system prompts you to place the Aspiration Point Alignment Tool at the LAS Aspiration Point to
proceed.
6. Open the LAS cover and locate the tool stored inside.
7. Place the tool onto a rack on the LAS track, and position the tube directly below the LAS probe, cen-
tered in that location.
8. Select OK in the prompt dialog box. The LAS probe moves to the tool at the aspiration point to
check the alignment.
9. When the procedure is complete, the system prompts you to remove the alignment tool from the LAS
track aspiration point.
10. Remove the tool and select OK.
11. Close the LAS cover.

Probes Tab
NOTE: With the exception of the Initialization command, commands sent to a non-initialized arm
that involve arm movements are ignored in order to avoid errors.
Initialize All Arms button

This button initializes all the probe arms. To prevent collisions and potential leakage, the arms cannot be
initialized individually. Initialization performs the following actions:
l Returns the arms to their home position.
l Moves the arms to the wash/clean station.
l Primes the rinse.
l Primes the clean.
An Arm Status field displays the initialization status in the status bar.
Errors and causes display in the Alarms section of the status bar.
Home All Arms button

This button returns all arms to their home position.
Probes
Select the arm to diagnose in this drop-down list.

See Also
l Replacing the Syringe and Syringe Tip
l CTS Piercer/Probe Replacement Procedure Overview

Voltages
Viewing the Voltages Screen

To view the Voltages screen:
2. Select the Voltages tab.
Voltages Tab
See Also

Universal Arm
Universal Arm
Viewing the Universal Arm Screen

To view the Universal Arm screen:
2. Select the Universal Arm tab.
Universal Arm Tab
See Also

Fluid Precision Test

Viewing the Fluid Precision Test screen

To view the Fluid Precision Test screen:
2. Select the Fluid Precision Test tab.
Fluid Precision Test Tab
See Also

Instrument Status
Instrument Status
The Instrument Status screen displays the following information:
l Current and previous versions of the ACL TOP software installed on the instrument, including asso-
ciated components and other information.
l Hardware updates performed on the instrument, if available.
l Alarms history.
The Instrument Status screen is typically used to view alarms history for diagnostic purposes. Some areas are
used exclusively by authorized service personnel for advanced troubleshooting.
NOTE: The functionality accessed through the toolbar icons described in this topic can also be
accessed in the menu bar as follows:

Viewing Instrument Status

To view instrument status:
1. Select System > Instrument Status in the menu bar to open the Instrument Status screen.
2. On the Versions tab:
l In the System version drop-down list, select the current or previous version of the ACL
TOP software installed on the instrument. A comprehensive list of components asso-
ciated with the selected version displays in the Software versions table.
l In the Event drop-down list, select a hardware update previously performed on the
instrument. The date and time, description and components details (if any) of the
selected hardware event display in the fields below.
3. On the Alarms grid and Alarms chart tabs:
l Select the Alarms Display Settings icon in the toolbar and configure the infor-
mation to display on these tabs. See Configuring the Alarms grid and Alarms chart
tabs.
l Select the Alarms Filter icon in the toolbar and configure the information to dis-
play on these tabs. See Filtering the Alarms grid and Alarms chart tabs.
4. To print the information displayed on a tab, select the Print icon in the toolbar.
Configuring the Alarms Grid and Alarms Chart tabs

To configure the alarms to display on the Alarms grid and Alarms chart tabs by ACL TOP software version
and by hardware event over a selected time span:
1. Open the Alarms grid or Alarms chart tab in the Instrument Status screen.
2. Select the Alarms grid or Alarms chart tab.
3. Select the Alarms Display Settings icon in the toolbar to open the Alarms Display Settings
dialog box.
4. On the Software Versions tab, use the arrow buttons to move the ACL TOP software versions whose
alarms you want to view to the Selected columns list.
5. On the Hardware Events tab, use the arrow buttons to move the hardware updates whose alarms you
want to view to the Selected columns list.
6. On the Chart Settings tab, configure the time span and alarm grouping to use when charting the his-
tory of an alarm.
7. Select OK.
The Alarms grid tab now displays the alarm sets you chose to view, and the and Alarms chart tab displays
the number of times the selected alarm triggered during the time span you configured.

Instrument Status
Filtering the Alarms Grid and Alarms Chart tabs

To filter by category the alarms that appear on the Alarms grid and Alarms chart tabs:
1. Open the Alarms grid or Alarms chart tab in the Instrument Status screen.
2. Select the Filter icon in the toolbar.

3. In the Alarms filter dialog box, select one or more filters options.
4. Configure the filter criteria for the filters enabled in the previous step. See Alarms filter dialog box.
5. Select OK. The filtered results appear on the Alarms grid and Alarms chart tabs.
Viewing Status Statistics

To view status statistics:
1. Open the Instrument Status screen.
2. Select Actions > Review > Status Statistics in the menu bar.
3. View status statistics in the Status Statistics screen.
4. Select the Reset button to reset the dynamic values in the Time and % columns back to zero and reset
the time stamp in the From field to the current date and time.
Instrument Status Operations Toolbar

The Instrument Status operations toolbar includes the following:
Add Hardware Event – Adds a new hardware update to display on the Versions tab. For
authorized service personnel only.
Edit Hardware Event – Edits an existing hardware update displayed on the Versions tab. For
authorized service personnel only.
Alarms Display Settings – Opens the Alarms display settings dialog box where you configure
the information displayed on the Alarms grid and Alarms chart tabs.
Alarms Filter – Opens the Alarms filter dialog box where you filter the alarms to display in
the Alarms grid and Alarms chart tabs.
Print – Prints the contents of the selected tab.

Versions tab
Software versions
System versions
Drop-down list of current and previous ACL TOP software versions installed on the instrument. The table dis-
plays the following information and components associated with the ACL TOP version selected in the list:
l System information
l Control Module versions
l Software component versions
l Language (other than English) use on the system
l Reports versions
l System DLL versions
Hardware events
Event
Drop-down list of hardware updates performed on the instrument.
D ate & Time

Date and time the selected hardware update was performed on the system.

Instrument Status
D escription
Description of the selected hardware update entered by the authorized service representative.
H ardware components version

Table of installed hardware components and versions, if available, associated with the update selected in the
Event list.

Alarms Grid Tab
Displays the alarms generated on the instrument by ACL TOP software version and by hardware event. Sta-
tistics for the alarm appear in the Total, Total% and Busy% columns.

Instrument Status
Total
Total number of times the alarm triggered during the time period configured in the Alarms filter.
Total %
Total number of times the alarm (in that row) triggered expressed as a percentage of all the alarms (all rows)
triggered during the time period configured in the Alarms filter.
B usy %
Percentage of time the instrument was in this error state (for alarm in that row) while the instrument was in
the Busy state.
See Filtering and Configuring the Alarms grid and Alarms chart tabs.

Alarms Chart Tab
This tab charts the number of times a selected alarm has triggered over a given time period.
D isplayed alarm
List of alarms configured on the ACL TOP instrument. Select an alarm in the list to display in the Alarms
chart tab.
See Filtering and Configuring the Alarms grid and Alarms chart tabs.

Instrument Status
Alarms Display Settings Dialog Box

Use this dialog box to configure the alarms set (by ACL TOP software version) to display on the Alarms
grid tab and to chart on the Alarms chart tab. See Configuring the Alarms grid and Alarms chart tabs.
Software Versions tab
Use this tab to display current and previous versions of the ACL TOP software installed on the instrument,
including associated components and other information.
Each ACL TOP software version displays in a separate column in the Instrument Status – Alarms grid tab, as
follows:

A vailable columns
List of current and previous versions of the ACL TOP software installed on the instrument. Alarms associated
with the ACL TOP software versions listed in this column will not display in the Alarms grid and Alarms
chart tabs after you select OK.
Selected columns
Use the arrow buttons to move ACL TOP software versions to and from this list. Alarms associated with the
ACL TOP software versions listed in this column will display in the Alarms grid and Alarms chart tabs after
you select OK.
Hardware Events tab

This tab is used by authorized service personnel for advanced troubleshooting.
A vailable columns
List of hardware updates performed the instrument. Hardware alarms associated with the ACL TOP software
versions listed in this column will not display in the Alarms grid and Alarms chart tabs after you select OK.
Selected columns
Use the arrow buttons to move ACL TOP software versions to and from this list. Hardware alarms associated
with the ACL TOP software versions listed in this column will display in the Alarms grid and Alarms chart
tabs after you select OK.
Chart Settings tab
Use this tab to configure a time period and grouping for the alarms to display on the Alarms chart tab.
D isplayed time period

Configure the time range parameters for alarms to chart as follows:

Instrument Status
l From – Select a beginning time stamp to display on the Alarms chart tab.
l To – Select an end time stamp to display on the Alarms chart tab.
Grouping
Configure the grouping parameters for alarms to chart as follows:
l Grouping value – Number of bars to group together on a chart for visual purposes. Select 1-99.
l Grouping by – Time span for the grouping value (minutes-years).
OK
This button applies the alarm display settings configured in the current dialog box session to the Alarms grid
and Alarms charts tabs.

Alarms Filter Dialog Box
Use this dialog box to filter by category the alarms listed on the Alarms grid tab and charted on the Alarms
chart tab. See Filtering the Alarms grid and Alarms chart tabs.
Enable filter by alarm code

Option to filter the alarms by the alarm codes. To use this filter, select this option and configure the range of
alarm codes to display in the From and To fields.
Enable filter by type

Option to filter the alarms by type. To use this filter, select this option and choose one of the following in
the Alarm type drop-down list.
l Error – Displays error alarms.
l Warning – Displays warning alarms.
Enable filter by date/time

Option to filter the alarms by date range or by the current date. To use this filter, select this option, then do
one of the following:
l Select the Filter by current date option.
l Configure the date range in the From and To fields.
Enable filter functional area

Option to filter the alarms by function. To use this filter, select this option and choose one of the following
in the Functional area drop-down list.
l Materials – Displays material alarms.
l QC – Displays QC alarms.
l Analyzer – Displays analyzer alarms.
l External Communications – Displays external communications alarms.
l Maintenance – Displays maintenance alarms.
l Job Frequency – Displays job frequency alarms.

Instrument Status
l Setup – Displays setup alarms.

l Other – Displays the alarms that are not included in the above categories.
All alarms
Option to cancel all filters. This option displays all alarms in the Alarms grid and Alarms charts tabs.
OK
This button applies the alarm filters and criteria configured in the current dialog box session to the Alarms
grid and Alarms charts tabs.

Status Statistics Screen
The Status Statistics screen displays a dynamic set of statistics relating to the operation of the ACL TOP
instrument. See Viewing status statistics.
From
Date and time the instrument began collecting the statistics currently displayed.
R eset
This button does the following:
l Resets the dynamic statistics displayed in the Time and % columns back to zero.
l Sets the time stamp in the From field to the current date and time.
l Immediately starts collecting a new set of statistics.
C olumn D escriptions
l Time – The amount of time the instrument has spent in the state indicated by the <row name> since
the date and time displayed in the From field.
l % – Percentage of operational time the instrument has spent in the state indicated by the <row
name> since the date and time displayed in the From field.
Statistics D escriptions
The time values displayed for the following statistics represent the total amount of time the instrument has
spent in that state since the time displayed in the From field:
l Power up – Time the instrument spent physically powering up.
l Initializing – Time the instrument spent starting up installed programs.
l Ready – Time the instrument spent in the idle state while prepared to run tests.
l Busy – Time the instrument spent performing activities.
l Error – Time the instrument spent partially or fully incapacitated because of an unresolved error.

Instrument Status
l Emergency stop – Time the instrument spent in emergency stops.

l Unknown – Time the instrument spent in an unidentified state.
l Diagnostics – Time the instrument spent performing diagnostic operations.
l Maintenance – Time the instrument spent performing maintenance activities.
l Warming up – Time the instrument spent warming up before entering the Ready or Busy state.
l Controlled stop – Time the instrument spent in controlled stops.
See Also
l Maintenance List
l Instrument Temperatures
l Analytical Versions

Instrument Temperatures
Viewing Instrument Temperatures

To view instrument temperatures:
1. Select System > Temperatures in the menu bar to open the Instrument Temperatures window.
2. To print the temperature data displayed in the window, select the Print button.
Instrument Temperature Window
The Instrument Temperature window displays the temperatures for the following instrument areas:
l Incubators
l 2-4 ORUs
l Reagent block area
l Cuvette shuttle
l Probes.
Values displayed in red are outside the accepted temperature range.
See Also
l Maintenance List
l Instrument Status
l Analytical Versions

Analytical Versions
Analytical Versions
Accessing Analytical Versions
To access the analytical versions of the installed test parameters:
1. Select System > Analytical Versions in the menu bar to open the Analytical Versions window.
2. To print the contents of this window, select the Print button.
Analytical Versions Window
C omponent
Name of the test parameter installed.
Installed Version
Current version of the test parameter installed.
Print
Prints the contents of this window.
See Also
l Maintenance List
l Instrument Status
l Instrument Temperatures

General Log List

In addition to error and warning-level alarms, the General Log contains informational alarm messages. These
messages contain information about an event that has affected system performance.
The General Log displays a maximum of 5000 entries. Entries are deleted on a first in/first out basis when
the log is full.
Accessing the General Log List

To access the General Log List:
1. Select System > General Log List in the menu bar or the General Log icon located on the left
side of the status bar.
2. Select the Add icon or select Actions > Log > Add to open a General Log Entry Creation win-
dow. You can add only informational entries.
Printing a Report
To print a General Log Detail report:
1. Double-click the log entry, or select it and click the Details icon.
2. Click Print in the General Log Entry Details window.
3. Configure print options in the Print dialog box and click OK. All the information displayed in the
General Log Entry Creation window prints.
Exporting a Report
l Select Actions > Export to export the General Log List report or the General Log Detail report. A
window opens that allows you to specify the format and select the destination. See Exporting Data.

General Log List
Clearing the Log List

To clear all log events from the General Log List:
l Select Actions > Results > Clear All Events in the menu bar.
General Log List Toolbar Icons
Log D etails icon

Select this icon or double-click an alarm message to view Description, Cause, Operator Action and Com-
ment details. You can select the up/down arrow icons to quickly scroll through the log list.
The log can be filtered to display data generated manually, automatically or semi-automatically. The default
time span is monthly, which displays data from the current date to the same date of the previous month.
R efresh icon
Select this icon to update the log.

Filter icon
Select this icon to open the General Log Filter dialog box. You can choose to filter the archived list by code,
type, start/end date, functional area, or user name. Select the Filter button to view your filtered list of
alarm messages.
A dd C omment icon
Select the icon or select Actions > Log > Add Comment in the menu bar to add a comment to an existing
log entry; a check mark is then placed in the box to the right of the entry in the General Log to indicate that
a comment has been added.
Print R eport icon

To print a General Log List report you must have the General Log List screen displayed, then select the
print report icon or select Actions > Print in the menu bar.
A General Log List report includes the following information:
l Date/Time of the report
l Hospital Name
l Laboratory Name
l Instrument and Serial Number
l Description/Comment
l Code
l Type
l Date/Time
l Functional Area
l User Name

General Log List
General Log Entry Creation window
Functional area
This includes the major areas of the system: Analyzer, Job Frequency, LIS, Maintenance, Materials, QC,
Setup, Others.
D escription
Enter the information you want kept in the General Log.
C omment
Enter a comment about this log entry.
OK
Select OK to add this entry to the list. After you select OK, you cannot delete your entry without deleting
the entire log.
See Also
l Status Bar
l Alarm Messages


CHAPTER 14 Backup and Restore
CHAPTER 14
BACKUP AND RESTORE
Backup and Restore
Overview
This topic provides instructions on how to backup and restore the database. The database contains all def-
initions and data. Backup and restore are both performed outside the ACL TOP instrument application.
NOTE:
l By default, the ACL TOP instrument uses the following editable naming convention when creating
backup files:
<serial number>_<date>_<time>.tdb
<serial number>_<date>_<time>.tzb
l A backup performed on an instrument that does not have the Serial Number information in the System
Identification area of Global Definitions cannot be restored. See Global Definitions.
l You can only restore to the same instrument on which the backup was performed.
l The security information fields displayed on this screen are for use by IL Test Developers and IL Serv-
ice personnel only.

Chapter 14 – Backup and Restore
Full Backup of Database

1. Remove any CD from the CD drive while the PC is starting up. A Microsoft Windows defect exists
that may cause the CD Drive to not be detected if there is a CD inside the CD Drive during startup.
2. Shutdown the ACL TOP instrument.
3. Select Start > Programs > ACL TOP > ACL TOP – Database Backup and Restore.
4. <Optional> For databases that are too large to fit onto one CD, select the Enable multi-volume
backup option.
5. <Optional> To delete patient information from the backup, select the Delete patient information
from backup option. to support patient confidentiality
6. Select Backup. A Save As dialog box opens.
NOTE: If you are asked to insert a disk into a drive, select Cancel to display the “Save As”
window.
7. Navigate to the desktop.
Alternatively, create a folder C:\ACL TOP Backups\, and save all database backups to this location.
8. Accept the default name for the backup file, or enter different name, and select Save.
NOTE: Use only alphanumeric characters, spaces, dashes and underscores for folder and fil-
enames.
9. Upon completion of the backup, the following message appears: The database backup has been
executed successfully.
10. Copy the backup file from the desktop to another location to prevent accidental deletion.
Example To CD or another accessible location on the hard drive.

11. Select OK, then Close to close the ACL TOP – Database Backup and Restore utility.
NOTE: At this point, if your system is using the CIS RecordNow application, refer to Section
3.0, Burn Backup of Database to CD using CIS RecordNow, for instructions on how to burn the data-
base to a CD. If you are using the Nero Express Essentials application, refer to Section 4.0, Burn
Backup of Database to CD or DVD using Nero Express Essentials for instructions on how to burn the
database to a CD or DVD.
12. Select Start > Programs > NTI CD-Maker > NTI CD-Maker 6 Gold.
13. In the NTI CD-Maker Gold window, select Data, then select Data CD.
14. Verify the correct CD Drive is selected in the drop down box at the top right of the window.
15. Select the Add icon (or Edit > Add). Navigate to the same location on the hard drive where the
database was previously saved (see: step 4, C:\ACL TOP Backups\).
16. Insert a blank CD-R into the CD Drive, then select the Write Disc icon (or File > Write Disc).
17. Select Start to burn the to the CD.

Backup and Restore
NOTE: It is recommended to run no other applications, including the ACL TOP application,
while the data is being copied to the CD.
18. When the data has finished coping, a message displays: Congratulations, The disc was recorded suc-
cessfully at…
19. Remove the CD from the CD Drive, and with a permanent marker, label the CD with the same name
as in step 5: “Backup_<SN>_MMDDYY”, where <SN> is the serial number of the instrument.
Example Backup_SN02110027_ 022804
20. Select OK, then close the NTI CD-Maker Gold application.
NOTE: If a message box is displayed asking if you want to save changes to the CD, select
No.
21. Start the ACL TOP application, and verify that the system initializes and the instrument goes to the
Ready state.

Full Restore of Database
NOTE: You can restore only backup files that were created on the same instrument where they are
stored.
A database can be restored from either the local hard drive, from a network drive or from a CD.
If you are restoring from a network drive or CD, select Enable network and CD access to enable that field.
1. Shutdown the ACL TOP instrument.
2. Select Start > Programs > ACL TOP > ACL TOP – Database Backup and Restore.
3. Choose Select to display the Open window.
4. In the Look in field navigate to the location of the database that you wish to restore (either on the
CD; the local hard drive, C:\ACL TOP Backups\; or the network).
5. Select the appropriate TDB file and then select Open. The suggested standard naming convention for
full database backups is: “Backup_<SN>_MMDDYY”, where <SN> is the serial number of the instru-
ment. Example Backup_SN02110027_ 022804.
6. Verify that the Installed Version fields on the left side are later than or equal to the Version for Restor-
ing fields on the right side. If the database being restored was created on a later software version than
the currently installed version, the ACL TOP instrument application fails to start.
7. Select Restore. Upon completion of the database restore the following message appears: “The Data-
base restore has been executed successfully.”
8. Select OK, then select Close to close the ACL TOP – Database Backup and Restore utility.
9. Start the ACL TOP application and verify that the system initializes and the instrument goes to the
Ready state.
NOTE: The ACL TOP - Creation and Upgrade utility is for IL use only.

Backup and Restore
Burn Backup of Database to CD using CIS RecordNow

1. Select Start > Programs > CIS RecordNow DX > RecordNow DX.
NOTE: If the CIS RecordNow DX Wizard does not automatically open, select File > Rec-
ordNow DX Wizard in the menu bar to open it.
2. In the CIS RecordNow DX Wizard, select Make a Data Disc.
3. Insert a blank CD-R into the CD Drive and select Next.
4. Select Add Files and Folders and navigate to the same location on the hard drive where the database
was previously saved. See: section 1 step 4, C:\ACL TOP Backups\.
5. Select Next. The data begins to burn to the CD.
6. A warning may be displayed stating that running other applications while the data is being burned to
the CD can cause the operation to fail. Select OK.
NOTE: It is recommended to run no other applications, including the ACL TOP application,
while the data is being copied to the CD.
7. When the data has finished coping, the following message appears: “Your disc was copied suc-
cessfully.”
8. Remove the CD from the CD Drive, and with a permanent marker label the CD with: “Backup_
<SN>_MMDDYY”, where <SN> is the serial number of the instrument.Example Backup_
SN02110027_ 022804
9. Select Done and close the CIS RecordNow application.
10. Start the ACL TOP application and verify the system initializes and the instrument goes to the Ready
state.

Burn Backup of Database to CD or DVD using Nero Express Essentials
1. From the desktop, double click the following Nero Express Essentials icon.
2. Select Data CD or Data DVD.
3. You can either drag-and-drop items into the window, or select the Add button to add files to the
disc. An Add files and folders browse window opens where you can select the files.
4. Select the files, then close the Add files and folders window.
5. Select Next.
6. In the Current Recorder field make sure the correct drive is selected.
7. Enter a disc name.
8. Select the Verify data on disc after burning option.
9. Disable the Allow files to be added later (multisession) option.
10. Insert a blank disc into the drive.
11. If the CD Drive (D:) window opens, select Cancel to close it.
12. Select the Burn button.
13. When the burn is complete, the drive automatically opens. Remove the disc and close the drive door.
14. A popup indicates if the verification of the disc is successful. If it is, select OK.
15. Select the Next button.
16. Close the Nero Express application. When asked to save the project, select No.

Backup and Restore
Backup and Restore screen
Backup splitting configuration
Enable multi-volume backup

Option to store large backup files on multiple disks.
Volume size
Size of the disks used to store the backup file.
Backup splitting configuration
D elete patient information from backup

Option to delete patient information from the backup file. This supports patient confidentiality.


CHAPTER 15 Parts and Consumables
CHAPTER 15
PARTS AND CONSUMABLES
Parts and Consumables List

l Most Frequently Ordered Items
l Less Frequently Ordered Items
l Reagent Racks, Diluent Racks, and Bottle Adapters
l Sample Racks and Bottle Adapters
Most Frequently Ordered Items

Item Part Number
Clean A, 0009831704
Blood Gas/Coagulation Cleaning Solution
4 x 500 mL
Clean B, 0009832700
Critical Care/HemosIL Cleaning Agent
1 x 80 mL
Factor Diluent 0009757600
1 x 100 mL
Rinse 00020009700
1 x 4000 mL
Bar code Labels for Factor Diluent, Clean B, Diluted Clean B 00028525200
Bottles, Plastic, 30 mL (with cap) 00018902000
10/package
Bottles, Glass, 20 mL 00019085463
8/package
10/package
10/package
Cups 2.0 mL, Sample 0005575100
1000/package

Chapter 15 – Parts and Consumables
Item Part Number

Cuvettes 00029400100
2400 cuvettes – 600 strips (4 cuvettes/strip)
300 CTS 00027336400
Cuvette Waste Liner
10/package
500 CTS 00029506900
Cuvette Waste Liner
10/package
All Models Except 300 CTS and 500 CTS 00029401100
Cuvette Waste Liner
10/package
300 CTS 00027333800
Filter, Reagent Cooling Fan
500 CTS 00029528901
Filter, Reagent Cooling Fan
All Models Except 300 CTS and 500 CTS 00028617301
Filter, Reagent Cooling
Magnetic Stir Bars 0009746606
6/package
Syringe Tip/Shaft 250 µL, PE, PSD4 00028754001
Waste Container 00018901300
10 L plastic bottle
CTS Filter 00029403501
12/pkg
Less Frequently Ordered Items

Item Part Number
ACL TOP Family Operator's Manual, Version 5.0.1, PDF (CD) 29244815 R01
Power Cable 110V 00014882100
Power Cable 220V 00019725500
Printer/Printer Cable/Printer Consumables Refer to your local representative.
Pump/Probe Tubing Assembly 00028741600
Rinse Aspirator Assembly, 4L 00028713400
(Tube connecting ACL TOP instrument to the Rinse Bottle)
Clean Aspirator Assembly 00028713200
(Tube connecting ACL TOP instrument to the Clean Bottle)
Stylet Kit 00019006300
Syringe, 250 µL PE, PSD4 00028753201

Item Part Number

LAS Syringe, 1000 µL, Tip/Shaft PE, PSD4 00028753401
Waste Sensor Assembly 00028771801
2D Bar Code Reader Upgrade Kit 00028210500
Tray, 6 Sample Racks 00028780201
CTS Sample Probe and Seal Assembly 00029508501
CTS Piercer 00029403601
CTS Filter Replacement Tool 00028386300
Reagent Racks, Diluent Racks and Bottle Adapters

Item Part Number
4 mL Reagent Bottle Adapter 00028520501
10 mL Reagent Bottle Adapter 00028520901
4 mL Diluent Bottle Adapter (2 pcs.) 00028526001
Reagent Rack Set, RA - RF (6 pcs) 00029400601
Reagent Rack Set, RA - RD (4 pcs) 00029400641
Reagent Rack Set, RG - RM (7 pcs) 00029400602
Reagent Rack Set, RE - RH (4 pcs) 00029400642
Diluent Rack Set, DA - DC (3 pcs) 00029400711
Diluent Rack Set, DA - DB (2 pcs) 00029400741
Diluent Rack Set, DD - DF (3 pcs) 00029400712
Diluent Rack Set, DC - DD (3 pcs) 00029400742
Sample Racks and Adapters

Item Part Number
Aliquot Tube Adapter (10 pcs.) 00028533400
Pediatric Tube Adapter (10 pcs.) 00028533500
Micro Tube Adapter (10 pcs.) 00028533700
Tray, 6 Sample Racks (1 pc.) 00028780201
CTS Sample Tube Adapter (10 pcs.) 00028533600
CTS Sample Rack Set, 01 - 08 00029400941

Item Part Number

Sample Rack Set, 1 - 8 00029400541
Sample Rack Set, 9 - 16 00029400542
Sample Rack Set, 17 - 24 00029400543
Sample Rack Set, 25 - 32 00029400544
Sample Rack Set, 33 - 40 00029400545
Sample Rack Set, 41 - 48 00029400546
Sample Rack Set, 49 - 56 00029400547
Sample Rack Set, 57 - 64 00029400548
Sample Rack Set, 01 - 12 00029400501
Sample Rack Set, 13 - 24 00029400502
Sample Rack Set, 25 - 36 00029400503
Sample Rack Set, 37 - 48 00029400504
Sample Rack Set, 49 - 60 00029400505
Sample Rack Set, 61 - 72 00029400506
Sample Rack Set, 73 - 84 00029400507
Sample Rack Set, 85 - 96 00029400508
CTS Sarstedt Adapters, 10 Pack 00029412700
CTS Sarstedt Sample Rack Set w/ Adapter 01 - 08 00029412601

Item Part Number

CTS Sarstedt Rack Set w/ Adapter 01-12 00029412501
See Also


CHAPTER 16 Reference
CHAPTER 16
REFERENCE
Reference Section Overview

The Reference section contains the following information:
l Toolbar Icons
l Grid Icons
l Graph Icons
l Measured Units
See Also
l Symbols
l Important Symbols
l Hazards

Chapter 16 – Reference
Toolbar Icons
Icon Description
Activate Alternate Lot
Activate Material Lot
Activate Multiple Lots
Add
Add/Remove Material
Add/Remove Tests
Analyzer Alarm
Analyzer Alarm Error
Analyzer Alarm Warning
Apply Checks
Assigned Values
Auto List
Bar Code and Comments
Chart/Grid View
Clear Rack

Toolbar Icons
Icon Description
Clear Tree Selection
Comment or View Comment
Copy
Copy Alternative Lot
Cuvette Holding Area
Delete
Delete Test
Details
Diluent Area
Enable/Disable Tests
Export
External Communications Alarm
External Communications Alarm Error
External Communications Alarm Warning
Filter

Icon Description
Filter in Use
Find
General Log
Go to Material Definition
Go to Test Definition
Help
Home Bar Code Reader
IL Logo/IL Test mode in Test List and Material List
Import
Insert Rack
Instrument Configuration
Job Frequency Alarm
Log
Maintenance Alarm
Maintenance Alarm Error
Maintenance Alarm Warning

Toolbar Icons
Icon Description
Show Material List
Material Restriction Map
Material Alarm
Material Alarm Error
Material Alarm Warning
Material Threshold Alarm
Material Threshold Alarm Error
Material Threshold Alarm Warning
Next Rack
Next Test Details
Omit Point
On-board Waiting for Volume
Open Calibration Status List
Open QC Results List
Open Sample Details
Patient Demographics

Icon Description
Perform Activity
Previous Rack
Previous Screen
Previous Test Details
Print or Print Report
QC Alarm
QC Alarm Error
QC Alarm Warning
QC Results or Status List
Rack Details
Reagent Area
Recalculate
Refresh
Reset
Restore
Run Jobs

Toolbar Icons
Icon Description
Sample Area
Sample Details
Sample List
Save
Scan Material Data
Select QC Profiles
Set Statistic as Target
Show Reaction Curve
Test Details
Show Test List
Test/Material Tree View
Upload
User
Validate
View Item
Warning Threshold

See Also
l Graph Icons
l Grid Icons
l Toolbar

Grid Icons
Grid Icons
Icon Description
All Tests
Alternative Lot
Alternative Prediluted Test
Auto Execution Mode
Calibration
Calibration Feasibility
Comments
Cooling
Cover Opening
DR Flag
Edit Leaf
Error
Error Status/Sample Highest Error
Extended Test
IL Material or IL Test
Information
Job Type
Leaf with Error

Lock Status
Material On-board
Material Referenced
Material Status Enabled/Disabled
No Tests
Normal Test
NPP Feasibility
Parallelism
Parallelism Feasibility
Partial Item or Partial Test
Patient Test

Icon Description
Print
Priority (Stat)
QC
QC Comment
QC Feasibility
QC Omitted Point
QC Status Enabled/Disabled
Reaction Curve
Rerun Test
Sample On-board
Sample Status
Selected Item/Test
Selection Column
Start Reagent
Stirring
Test Consistency
Test is a Rerun
Test Triggered a Rerun
Test Leaf
Enable/Disable Test or Show/Hide Test
Upload Status
Validation Status
Waiting for On-board Material Volume
Warning
See Also
l Graph Icons
l Toolbar Icons
l Toolbar

Graph Icons
Graph Icons
Icon Description
Black Point - Calibration edited point
Blue Point
l Calibration omitted point
l Parallelism point
l QC active results
Green Point - Calibration normal point
Orange Point - QC alternate active results
Black Cross Point - Calibration deleted point
Blue Cross Point - QC active omitted point
Orange Cross Point - QC alternate omitted point
Blue up arrow - QC active out up
Blue down arrow - QC active out down
Orange up arrow - QC alternative out up
Orange down arrow - QC alternate out down
Blue line - Replicate 1 clot curve or Parallelism curve
Cyan line - Replicate 1 second derivative
Brown line - Replicate 3 second derivative
Dark gray line - Replicate 2 second derivative
Dark green line
l Calibration line
l Replicate 2 clot curve
l QC trend line
Violet line - Adjusted calibrated curve
Dark yellow line - Replicate 3 first derivative
Magenta line - Replicate 1 first derivative
Orange line - Replicate 3 clot curve
Red line
l Calibration curve (if it has failed)
l QC mean line
Black line - Replicate 2 first derivative
See Also
l Grid Icons
l Toolbar Icons
l Toolbar

Sample Status Color Codes

Icon Description
Not Placed Gray
To Do Light blue
To Do – Priority Light blue
Placed – Identified Blue
Placed – Unidentified Blue
Placed – Priority Blue
Pending – Identified Orange
Pending - Identified with Errors Orange
Pending – Priority Orange
Pending - Priority with Errors Orange
In Use – Identified Purple
In Use - Identified with Errors Purple
In Use – Priority Purple
In Use - Priority with Errors Purple
Complete – Identified Green
Complete - Identified with Errors Green
Complete – Priority Green

Sample Status Color Codes
Complete - Priority with Errors Green
Not Feasible - Identified Yellow
Not Feasible - Identified with Errors Yellow
Not Feasible - Priority Yellow
Not Feasible - Priority with Errors Yellow
NOTE: When the status of a sample rack is green, the rack can be removed. When the status changes
to amber the sample rack is locked and cannot be removed.
See Also
l Sample Rack Detail screen
l Reagent Area
l Diluent Area

Reagent Status Color Codes
Reagent Placement
Icon Description
Not Placed Gray
Placed – Unidentified Green
Placed – Identified Green
Placed – Warning Yellow
Placed – Error Red
In Use Green
In Use – Warning Yellow
In Use – Error Red
Reagent Remaining Stability

Icon Description
Stability OK Green
Stability Warning Yellow
Stability Alarm Red

Reagent Status Color Codes
Reagent On-board Volume

Icon Description
Volume OK Green
Volume Warning Yellow
Volume Alarm Red
On-board Waiting for Volume
See Also
l Sample Rack Detail screen
l Reagent Area
l Diluent Area

LED Status Color Codes

Icon Description
Gray - Empty track
- Auto Run status is Disabled
- LAS status is Disabled
Green - Rack is inserted but is not in use
- AM status is Ready
- LIS status is Connected
- Auto Run status is Enabled
- LAS status is Ready
Blue - AM status is Busy
Amber - Rack is in use
- AM status is Error
- LIS status is Rejected
- Auto Run status is Stopped
- LAS status is Unavailable or Stopped
Red - Auto Run status is Error
Green - Cuvette Door is Open
Yellow - Waste Fluid status is Warning
- Clean Fluid status is Warning
- Rinse Fluid status is Warning
- Cuvette Waste status is Warning
- Cuvette Loader status is Warning
Gray - Cuvette Door is Closed
- Waste Fluid status is OK
- Clean Fluid status is OK
- Rinse Fluid status is OK
- Cuvette Waste status is OK
- Sensor is Off
- Sensor status is Unknown
Red - Waste Fluid status is Full
- Clean Fluid status is Empty
- Rinse Fluid status is Empty
- Cuvette Waste status is Full or Removed
- Cuvette Loader status is Empty
See Also

Measured Units
Measured Units
Measured Units
l Seconds
l Mean
l Transmittance
l % Transmittance
l Delta Transmittance
l Delta Transmittance/min
l Delta % Transmittance
l Delta % Transmittance/min
l Milliabsorbance
l Delta Milliabsorbance
l Delta Milliabsorbance/min
Calculated Units
l Ratio
l INR
l Delta-R%
l PiCL%
Parallelism Units
l Mean of the 100% concentration
l Mean of corrected primary result (excluding 100%)
l Mean of corrected primary result (including 100%)
l r2 (Coefficient of Determination)
l Slope
l y-intercept
l % CV of corrected primary results (excluding 100%)
l % CV of corrected primary result (including 100%)
l % CV within Dilution
Calibrated Units
l %
l g/L
l mg/L

l μg/mL
l mg/dL
l ng/mL
l U/mL
l IU/dL
l IU/mL
l mU/mL
l AU/mL
l μmol/L
l nmol/L
l [blank] = user defined
Calibration Units
l slope
l y-intercept
l r2
Statistical Units
l % CV
l SD
l slope
Paired Results Units

l Test Ratio: Calculated as (S1/S2)
l Test Ratio - N%: Calculated as ((S1/S2) / (NPP1/NPP2)) * 100
l Test Ratio - N: Calculated as ((S1/S2) / (NPP1/NPP2))
l Test Delta: Calculated as (S1-S2)
l Test Delta %: Calculated as ((S1-S2) / S1) * 100
l Test Delta - N: Calculated as ((S1-S2) / (NPP1 – NPP2))
l Test Delta - N%: Calculated as ((S1-S2) / (NPP1 - NPP2)) * 100
See Also
l Measured Parameters

CHAPTER 17 IL Locations
CHAPTER 17
IL LOCATIONS
Instrumentation LaboratoryWorldwide Locations

IL Corporate Headquarters
Aragón 90-08015 Barcelona, Spain
P.O. Box 35027 (08080)
Telephone: 34-93-4010101
Fax: 34-93-4513745
http://www.ilww.com/
USA, Canada, Latin America

Headquarters
Instrumentation Laboratory Company
180 Hartwell Road
Bedford, MA 01730-2443 U.S.A.
Telephone: 1-781-861-0710
Fax: 1-781-861-1908
http://www.ilus.com
Mexico
IL Diagnostics S.A. DE CV
Lago Victoria 80
Colonia Granada
11520 Mexico DF
Phone: 52-55-5262-1760
Fax: 52-55-5262-1763
Pacific
Headquarters
Instrumentation Laboratory
Hamamatsucho General Bldg. 9F
2-2-15, Hamamatsucho, Minato-ku,
Tokyo, 105-0013, Japan
Telephone: 81-3-3437-6350
Fax: 81-3-3437-6352

Chapter 17 – IL Worldwide Locations
Hong Kong
Werfen Hong Kong Ltd.
Unit 4, 10/Fl., Eton Tower, 8 Hysan Ave.
Causeway Bay, Hong Kong
Telephone: 852-27927773
Fax: 852-27919972
Japan
Headquarters
Hamamatsucho General Bldg. 9F
2-2-15, Hamamatsucho, Minato-ku,
Tokyo, 105-0013, Japan
Telephone: 81-3-3437-6350
Fax: 81-3-3437-6352
Korea
Headquarters
Werfen Medical IL, Ltd.
101 Nashil Bldg. 604-1
Yeoksam-Dong - Kangnam-ku
135-907 Seoul
Korea
Telephone: 82-2-571-9246
Fax: 82-2-571-9247
Europe, Middle East, Africa

Headquarters
Instrumentation Laboratory SpA
Viale Monza 338
20128 Milan, Italy
Telephone: 39-02-25221
Fax: 39-02-2575250
http://www.il-italia.it
Austria
Instrumentation Laboratory Gesellschaft m.b.H.
Tillmanngasse 5
1220 Vienna Austria
Phone: 43-1-2565800-0
Fax: 43-1-2565800-88
Belgium
Instrumentation Laboratory (Belgium) N.V./S.A.
Excelsiorlaan 48-50 bus 8
1930 Zaventem (Brussels) – Belgium
Telephone: 32-2-7252052
Fax: 32-2-7212409

Instrumentation LaboratoryWorldwide Locations
Czech Republic1
Instrumentation Laboratory Czech
Plananska 1
10800 Praha 10, Czech
Telephone: 420-2-7816047
Fax: 420-2-7817434
France
Instrumentation Laboratory S.A.
32 Avenue de Saint-Mandé
B.P. 35 – 75560 Paris Cedex 12 France
Telephone: 33-1-53338600
Fax: 33-1-53338601
Germany
Instrumentation Laboratory GmbH
Klausnerring 4
D-85551 Kircheim bei München, Germany
Telephone: 49-89-909070
Fax: 49-89-90907116
Hungary2
Diagnostic Division of Comesa
Folyondar u. 1
H-1037 Budapest
Hungary
Telephone: 36-1-4392910-11
Fax: 36-1-242-3334
Italy
Headquarters
Instrumentation Laboratory SpA
Viale Monza 338
20128 Milan, Italy
Telephone: 39-02-25221
Fax: 39-02-2575250
http://www.il-italia.it
Lithuania
Instrumentation Laboratory (Lietuva) B.I.
Savanoriu 281A
3009 Kaunas – Lithuania
Telephone: 370-37-313157
Fax: 370-37-313159

Chapter 17 – IL Worldwide Locations
Poland3
Instrumentation Laboratory Poland
Wolinska 4
03-699 Warszawa, Poland
Telephone: 48-22-3361800
Fax: 48-22-3361872
Netherlands
Instrumentation Laboratory (Netherlands) B.V.
Moskesbaan 2
4823 AH Breda – The Netherlands
Telephone: 31-076-5480100
Fax: 31-076-5480102
United Kingdom
Instrumentation Laboratory (U.K.) Ltd.
Kelvin Close – Birchwood Science Park
Warrington, Cheshire WA3 7PB – England
Telephone: 44-1925-81-0141
Fax: 44-1925-826708
Russia
Headquarters
16/2 Dmitry Ulyanov Street 189 Office
117292 Moscow
Russia
Telephone: 7-495-124-45-59
Fax: 7-495-982-37-23
1IL Czech is the Diagnostic Division of Comesa Czech, a CH-Werfen Company
2IL Hungary is the Diagnostic Division of Comesa Budapest, a CH-Werfen Company
3IL Poland is the Diagnostic Division of Comesa Polska, a CH-Werfen Company

Glossary
See "Terminology" on page 82 for more definitions.
acquisition time
The amount of time that optical data is collected by the system. Acquisition Time can be either
Standard or Extended. Standard Acquisition Time is the time spent collecting the required number
of data points to determine the clotting point or reaction rate for the majority of samples. With
Extended Acquisition Time, data is collected for a longer period of time to determine the clotting
point for samples which have prolonged clotting times.
aliquot
A known fraction of a whole, constituting a sample.
AM
Part of the instrument where the sample processing and testing are performed. Alternately referred to
as the AM, the Analyzer, and the Analytical Module.
Analytical Module
Analyzer
Cal
Calibrator. A type of sample with an assigned value used to calibrate a test.
calibrator
A type of sample with an assigned value used to calibrate a test.
carryover
Residual sample material left on the sample probe, after the probe has been rinsed, that carries over
to another sample when the probe enters it.
CM
A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the
User Interface and data management functionality. The CM connects to the Analytical Module and
provides the high level controls.

Glossary
Control Module
A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the
User Interface and data management functionality. The CM connects to the Analytical Module and
provides the high level controls.
cuvette strip
DI water
Deionized water.
error
An error message indicates that a condition has been detected that requires immediate action. Fail-
ure to act may result in the instrument performing an emergency stop.
focus
To place focus on the unique identifier in a list, click a row in the table. A blue cell border indi-
cates focus. Only one unique identifier in a list can have focus.
indexer
The part of the cuvette loader which prepares cuvettes for pick-up by the shuttle mechanism.
INR
International Normalized Ratio. This value is used to standardize the reporting of Prothrombin Time
(PT) worldwide.
ISI
International Sensitivity Index. This value is provided by each Prothrombin Time (PT) reagent and
used TO calculate the International Normalized Ratio (INR).
LAS
Laboratory Automation System
mixture
A dilution that requires a two-step dilution process to achieve the required dilution ratio.

neat calibrator
Undiluted calibration plasma (100% strength).
NPP
Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the Inter-
national Normalized Ratio (INR) and when calculating test results that use the normalized ratio.
object
A data item in the Working Area of the ACL TOP application. For example, the unique identifier in
a table, a maintenance activity, or function, etc.
select
Click in the Selection column of a table. A red check mark indicates selection. You can select more
than one object.
Select
Click in the Selection column of a table. A red check mark indicates selection. You can select more
than one object.
stat
In medical terminology, immediate; with no delay. Stat samples have highest priority.
test profiles
A test profile is a grouping of tests. When you associate the test profile with a sample, all the tests
in the profile run on sample.
validate
The acceptance of test results by the user.
validated
Test results accepted by the user.

Glossary
warning
A warning message indicates that some user action may be required. Warnings do not affect the
operation of the instrument. However, an error condition may eventually occur if the operator does
not perform the required action.

Index
ACTIVE Status 608

# Activity Definition 787, 790
# Tests or Piercing 789 Adapters 360, 404, 408, 410, 419, 426, 431, 450,
755, 913
Add 114, 131-132, 138, 159, 166, 175-176, 195,
% 198, 247, 312, 314, 322, 325, 327, 330, 356,
%CV Max 272 359, 368-369, 381-382, 507, 522, 560, 591,
645, 783, 790, 794, 885, 900, 906, 910
%CV of Corrected Result (CR) 100% 279
Add - Icon 920
%CV of Corrected Results (CR) 282
Add a Comment 438, 453, 902
%CV of Corrected Results (CR) 100% 282
Add a Material 133, 175
Add a Material Load Cycle Definition 175
1 Add a New Maintenance Activity 787, 794
1D Bar Code Reader 388
Add a New Material 132, 312
Add a New Test Definition 920
2 Add a New Vial 131
2D Bar Code Reader 47, 388, 915 Add a Result Unit 246
2D Bar Code Scanner 78, 388, 393 Add a Test 158, 165, 175, 560
Add a User-Defined Test Definition 159
A Add an Item 114
Absolute Value of Referenced Curve 225 Add/Remove Material 386-387, 435, 443, 451, 461
Access Level 367, 374, 631 Add/Remove Material - Icon 920
Accessing Alarm Messages 645 Add/Remove Tests 500, 507, 518, 565, 567, 571, 575,
578-579, 591
Accessing Data Flags 775
Add/Remove Tests - Icon 920
ACL TOP Base Model 14
Add/Remove Tests and Profiles 567
ACL TOP Instrument Models 14
Adding a User 369
ACL TOP User Interfaces 77
Additional Preparation 385
ACL TOP Versions 886, 899
Adjusted Y Intercept 491
Acquisition Time 163, 170, 177, 209, 223, 304
Adjustment Volume 86
Acquisition Wavelength 177
Africa - IL Location 937
Actions Upon Delivery 70
After Each Dispensation of Same Material 148
Activate Alternate Lot 154, 509, 533
Airgap 149, 182, 192, 275, 793
Activate Alternate Lot - Icon 920
Alarm Buttons 105, 753
Activate Material Lot 138
Alarm Messages 645, 753, 900
Activate Material Lot - Icon 920
Alarms Chart 890
Activate Multiple Lots - Icon 920
Alarms Display Settings 884, 891
Active Lot 152, 156, 268, 315, 393, 499, 506, 509,
511, 518, 521, 570 Alarms Filter 884, 894
Active Lot - 2D Bar Code Scan 395 Alarms Grid 888

Index
Algorithm 198, 201, 218, 245, 251, 262, 306, 336, Auto List 544, 567, 576
621 Auto List - Icon 920
Aliquoting Area 86, 365 Auto Print Setup 378
Aliquoting Area Expiration Time 86 Auto Run 105, 125, 317, 319, 345, 361, 479, 481,
All Results - Filter Option 629 512, 934
All Samples - Filter Option 634 Auto Run Status 105, 125, 934
All Tests - Icon 927 Auto Validation 48, 50, 53, 120, 334, 485
Allow Expiration - UID Option 373 Auto Validation Errors 336
Alternate Lot 136, 140, 156, 277, 315, 393, 444, 462, Automatic Dilution 267
495, 499, 506, 509, 512, 518, 521, 565, Automatic Fluidic Line Priming Cycle 780, 797, 816
927
Automatic Material Identification 388
Alternate Lot - Activate 509
Automatic NPP 507
Alternative Lot - Icon 927
Automatic Positive Material ID 386
Alternative Pre-diluted Test - Icon 927
Automatic QC 319, 519
Alternative Pre-dilution 195
Automatic Routine Clean for all Probes 780, 798,
Analytical Cycle Definition 149, 175, 188 817
Analytical Limitations 62 Auxiliary Material Status 397-398, 400, 442, 459
Analytical Module (AM) 14
Analytical Reference 82, 405
B
Analytical Versions 899
Backup 905
Analyzer Alarm 664
Backward Search Direction - Algorithm 225
Analyzer Alarm Error - Icon 920
Bar Code 10, 14, 47, 49, 52, 78, 133, 143, 339, 350-
Analyzer Alarm Warning - Icon 920 351, 353, 360, 386, 390, 393, 404, 419-
Analyzer Alarms - Icon 920 420, 435, 446, 451, 464, 482-483, 544,
Analyzer Status 18, 104, 107, 126, 643, 934 561, 566, 574, 576, 618, 755, 862, 873,
913
Analyzer Status Indicators 643
Bar Code - Icon 920
Annual and Semi-Annual Maintenance 780
Bar Code Definitions Setup 350
Apply Checks - Icon 920
Bar Code Errors 395
Apply Consistency Checks 167, 169, 176
Bar Code Formats 351
Apply Filter 645, 902
Bar Code Label 152, 351, 353, 393, 419, 570, 755
As Needed Frequency Setting 792
Bar Code Label Placement 353
As Needed Maintenance 780
Bar Code Reader 10, 18, 23, 47, 49, 52, 78, 351, 386,
Aspiration Cycles 149, 185
390, 420, 482-483, 544, 576, 873,
Aspiration Information 182 915
Aspiration Point 86, 479, 823, 876 Bar Code Reader Indicator 558
Assay Release Number 171 Bar Code Reading Configuration 350
Assay Settings 171 Bar Coded Samples 574, 576
Assigned Values 140, 155, 388, 393, 486-487, 511, Baseline by Moving SD 209
536
Baseline Check 214
Assigned Values - Icon 920
Baseline Time 221
ASTM-1394 Compatible Mode 356
Baseline/Endpoint Averages 221
ASTM-1394 Configuration 354
Batch 9, 271, 293, 574
Austria - IL Location 937
Before You Begin Calibration 499
Auto Execution Mode - Icon 927
Before You Begin NPP 506

Before You Begin QC 515 Calibrator 82, 141, 155, 213, 275, 279, 367, 405,
Belgium - IL Location 937 421, 486-487, 499, 570
Between Changes in Material Only - Setting 148 Calibrator Lot Number 486-487
Biohazards 3, 5 Calibrator Volume 272
Black Number - Text Symbol 468 Canada - IL Location 937
Black Unbolded - Text Symbol 608, 612 Cancel an Operation 128
Blue Unbolded - Text Symbol 608, 612 Carriage - Cuvette Shuttle 83
Bottle Adapters 404, 419, 913 Category Type - Material 142
Bottle Type 131, 143, 395 Cautions 3-4
Bringing Into Operation 71 Cavro Syringe 843
BUSY Status 104 CD-ROM Drive 79
By Number of Piercings - Maintenance 780 Certification 43, 72
Change Fluid Waste Container 403
Change Rinse Fluid 398
C
Change Tree View 520
Calculated Units 250, 935
Chart Icons 929
Calculated Value 491
Chart View 521, 533, 535, 538
Calibrated Result Delta Check 213
Chart View - Icon 920
Calibrated Unit Data 252
Chart View Display Settings 537
Calibrated Units 250, 935
Check Value - Data Curve 226
Calibration - DR Parameters 262
Chromogenic Absorbance Measurement 12
Calibration - General Parameters 259
CIS RecordNow 909
Calibration - Icon 927
Clean Airgap 149, 185
Calibration - Programming 499
Clean and Rinse Cycles 185
Calibration Curve 48, 50, 53, 154, 262, 279, 295, 300,
486-487, 490, 616, 929 Clean B Diluted 88, 149, 182, 185, 422-423, 552
Calibration Details 298, 485-486, 499, 776 Clean Cup Area 453, 780, 799, 808, 818, 832
Calibration Feasibility 470, 927 Clean Cuvette Waste Drawer 798, 817
Calibration Feasibility - Icon 927 Clean Deep Wash and Clean Cup Area 799, 818
Calibration Frequency 261 Clean Fluid 4, 32, 186, 400, 442, 459, 756, 934
Calibration Information 493, 776 Clean Fluid Status 442, 459, 934
Calibration Jobs Counter 631 Clean Material 20, 88, 149, 182, 185, 360, 364, 422-
423, 552, 793, 801-807
Calibration Mode 259
Clean Monitor 863
Calibration Points 929
Clean Rack Areas 799, 819
Calibration Points Definition 271
Clean Reagent Cooling Filter 864
Calibration Report 488
Clean Solution System 14
Calibration Result 259, 335, 485
Clean Total Volume 150, 185
Calibration Setup 256
Clean Transport Airgap 150, 185
Calibration Statistics 490
Clean Transport Volume 150
Calibration Status List 266, 486, 497, 776
Clean Volume 150, 185-186
Calibration Status List - Icon 920
Clear Rack - Icon 920
Calibration Units 259, 499, 936
Clear Tree Selection 516, 519, 533
Calibration/NPP/AR 82
Clear Tree Selection - Icon 921
Calibrations Counter 631
Closed Tube Sampling 47, 49, 426

Index
Clot Curve Analysis 621, 929 CTS Foot Cleaning 799, 820
Coagulometric Turbidimetric Measurement 12 CTS Parameters 348, 427
Codabar NW(7) Japan 351 CTS Piercer/Probe Replacement 848
Code 128 351 CTS Probe 428
Code 39 351 Curve Analysis 621
Color Codes 18, 104, 125, 445, 463, 556, 605, 929- Cut-off - Calibration Setting 266
930, 932, 934 Cuvette 16, 52, 75, 82, 179, 190, 268, 348, 360, 364,
Color, Visual Style 91 397, 442, 482, 560, 755, 798, 866, 914, 934
Comments 147, 315, 372, 438, 453, 486, 495, 501, Cuvette Blind Volume 348
522, 534 Cuvette Box - Term 82
Comments - Icon 921, 927 Cuvette Cell - Term 82
Common Functions 108 Cuvette Dead Volume 183, 190, 273
Commonly Used Terms 1 Cuvette Door 934
Communications - LIS 354 Cuvette Evacuation Cycle 780, 799, 821
Component Delimiter 357 Cuvette Holding Area - Icon 921
Compute Value from Calibration Curve Equation 300 Cuvette Holding Area - LAS 560
Concentration 12, 82, 195, 263, 285, 297, 300, 543, Cuvette Loader 22, 83, 442, 459, 934
935
Cuvette Loading Area 21
Configure Display Settings 379
Cuvette Overflow Volume 348
Configure Maintenance Activity 790
Cuvette Shuttle 21, 83
Configuring NPP 298
Cuvette Slot - Term 84
Confirm Password 373
Cuvette Strip - Term 84
CONNECTING Status 104
Cuvette Waste - Term 85
Connectors - Monitor 39
Cuvette Waste Bin 84
Consistency 164, 176, 311, 468
Cuvette Waste Container 34, 84, 821
Consistency Check 167, 174, 311
Cuvette Waste Drawer 16, 85, 779, 798, 817, 862
Containers 47, 49, 52, 85, 360, 408, 426, 755, 821
Cuvette Waste Status 442, 459, 934
Control Module (CM) 14
CV 55, 251, 282, 294, 539
Controlled Stop 32, 87, 104, 479, 643
CV% 488
CONTROLLED STOP Status 104
Czech Republic - IL Location 937
Controllers 871
Conversion Factor - Result Units 250
Cooling - Icon 927
D
Copy - Icon 921 Daily Maintenance 779
Copy a Test 159 Damage during Transportation 74
Copy Alternative Lot - Icon 921 Dangers 4
Copyright 2 Dark Readings 869
Corporate Headquarters - IL 937 Data Flags 757, 775
Correction Factor - Calibration Setting 260 Data Reduction Parameters 198
Correlation Range Minimum and Maximum 253 Date & Time - Sample Parameter 605
Cover 816, 871 Dead Volume 144, 183, 190, 273
Cover Open - Maintenance Req. 789 Dec. - Result Unit Setting 249
Cover Opening - Icon 927 Decimals 251
Create a User-Defined Test 159 Decontamination 862

Deep Wash Area 818

Default File Path 346 Direct Test 12

Deficient Plasma 88, 135, 143 Disable a Test 161
Define a New Test Definition 166 Disclaimers 74
Define Points by % Dilution 267 Diskette Drive 80
Define Points by Target Concentration 267 Dispensation Information 183
Defining QC Profiles 327 Display Alternate Lot 537
Delay Time 172, 178, 209, 260 Display Derivative Curves 345, 619, 621
Delete 116, 135, 160, 176, 247, 312, 321, 359, 371, Display Diluent Area 544
560, 796 Display Overview - User Interface 379
Delete - Icon 921 Display Reagent Area 544
Delete a Calibration Point Value 487 Display Sample List 544
Delete a Maintenance Activity 796 Door Open Status 442
Delete a Material 133 DR Errors 308
Delete a Material Load Cycle Definition 176 DR Flag - Icon 927
Delete a QC Profile 327
Delete a QC Test 312
E
Delete a Result Unit 247
Edit a Parallelism Definition 291
Delete a Test 160, 321, 560, 599, 920
Edit a QC Profile 327
Delete an Item 116, 787
Edit a User 370
Delete Test - Icon 921
Edit Assigned Values 155
Deleting a User 371
Edit Global Options 347
Delimiter - LIS 357
Edit Leaf - Icon 927
Delta - QC Results 539
Edit NPP 298
Delta Algorithm 237
Edited Point 929
Delta Checks 212, 230
Electrical Requirements 67
Delta of Curve 220, 759
Emergency Stop 18, 104, 476, 478, 482, 897
Demographic 377
Emergency Stop Button 18, 482
Derived from Calibration 300, 491
EMERGENCY STOP Status 104
Derived from Calibration - NPP 300
Empty Cuvette Waste 800, 821
Details - Icon 921
Empty Material 88
Diagnostics 865
Empty Waste Fluid 800, 822
DIAGNOSTICS Status 104
Enable %CV Check 262
Diluent 88, 194, 276, 419, 436, 447, 449, 467, 545
Enable 0% Dilution Target Value 263
Diluent Area 16, 436, 447, 449-450, 467, 545
Enable a Test 161, 172, 178
Diluent Area - Icon 921
Enable Agitation 149-151, 184, 186
Diluent Material 256, 293
Enable Alternate Lot 153, 512
Diluent Rack 26, 419, 448, 465, 515, 913
Enable Ambient On-Board Stability Tracking 138
Diluent Rack Details 449, 465
Enable as Paired Test 173
Diluent Volume 272
Enable as Shadow Test 172
Diluted LIS Number 197
Enable Auto-Validation 335
Dilution Parameters 347
Enable Automatic Execution 302
Dilution Point 262
Enable Bar Code 350
Dilution Process 293
Enable Baseline by Moving SD 209
Direct Delivery Mode 256

Index
Enable Baseline Check 214 Enable Parallelism 292

Enable Calibration 258 Enable R2 Check 265, 296
Enable Check Wavelength 175, 344 Enable Range for Secondary Algorithm 245, 262
Enable Checksum 351 Enable Raw Data Checks 205
Enable CTS 427, 726 Enable Reagent Bar Code Reading 350
Enable Curve Sequence Check 207 Enable Reference Method 201, 225
Enable Display of Derivative Curves 621 Enable Refrigerated On-board Stability Tracking 138
Enable Display Transformed Axes 491, 620 Enable Rerun 305
Enable Endpoint Check 215 Enable Result Correlation 253
Enable Expiration Tracking 146 Enable Rules 316
Enable Extended Expiration Date 153 Enable Sample Bar Code Reading 350
Enable Extended Test Mode 179 Enable Sample Pre-Dilution 189
Enable Extrapolation 262 Enable Signal Check 206
Enable First Point Check 205 Enable Slope Check 263, 295
Enable Frequency 261, 302 Enable Spike Removal Check 208
Enable Global Reflex 346 Enable Substitution Method 207
Enable Global Rerun 346 Enable Test Range 254
Enable Host Communication 355 Enable Therapeutic Range 254
Enable Import Calibration 259 Enable Threshold Check 226
Enable Incubation Time 184 Enable Threshold Check Error 226
Enable Initial Slope Check 223 Enable Time Span Check 226
Enable ISI Value 138 Enable Trend Check 265
Enable Keypad 347 Enable Volume Threshold 145
Enable Keypad for Sample ID 347 Enable Warning Threshold 146, 261, 302, 317-318,
Enable Large Intercharacter Gap 351 783, 791, 793-794, 797-815
Enable LAS Track 363 Enable Wavelength Warnings/Errors 201
Enable Last Point Check 206 Enable Y-Intercept Check 263
Enable Linear Range 254 Enable/Disable Test 161-162, 928
Enable Linear Regression SD Error Check 222 Enable/Disable Tests - Icon 921
Enable Linear Regression SD Warning Check 222 Enabled Material 137
Enable LIS 355 Endpoint Algorithm 219
Enable Lot Management 152, 155, 337 Endpoint Check 215
Enable Max Difference 249 Endpoint Time 219
Enable Mix 183, 190, 273 England - IL Location 937
Enable Monotonic Check 265 Enhanced Clean for All Probes 801, 823
Enable Multiple Threshold Check 216 Enhanced Clean for LAS Probe 780, 802, 825
Enable Normal Range 254 Enhanced Clean for Reagent 1 and 2 Probes 803, 826
Enable Normalization Method 201 Enhanced Clean for Reagent 1 Probe 780, 804, 827
Enable Normalized Curve Delta 212 Enhanced Clean for Reagent 1, 2 and Sample Probes816
Enable Normalized Data Checks 211 Enhanced Clean for Reagent 2 Probe 780, 805, 828
Enable NPP 299 Enhanced Clean for Reagent Probe 806, 829
Enable Optical Interference Check 243 Enhanced Clean for Sample Probe 807, 830
Enable Outlier Removal 263 Enhanced Dispense 183
Enable Paired Test Dependency 173 Environmental Conditions 68

ERange 244 Factor Parallelism - Reporting Units 280

Error - Icon 927 Feasibility Test List 468
Error Alarm Buttons 753 Feasibility Test List - Icon 921, 927
Error Data Flags 757 Field Delimiter 357
Error Limit 222 Fill Volume 145, 348, 412
Error Limit and Tolerance 244 Filter 118, 132-133, 158, 162, 312, 314, 520-521,
Error Messages 105, 201, 645 525, 602, 634, 645, 782, 790, 796, 860, 884-
885, 902
ERROR Status 104
Filter - Icon 921
Error Status - Icon 927
Filter by Current Date 635
Errors - Bar Code 395
Filter by Failed Jobs 637
Escape Delimiter 357
Filter by First Test Performed Date/Time 634
Europe - IL Location 937
Filter by Job Error 641
Events 886, 901
Filter by Job Type 640
Exact Start/End Time 221
Filter by Last Test Performed Date/Time 634
Exit the ACL TOP Software 130, 477
Filter by Ordered Date/Time 635
Expected Slope 264
Filter by Patient ID 637
Expected Y-Intercept 264
Filter by Patient Last Name 637
Expiration Date 136, 146, 395, 443, 445, 461, 463,
495, 505, 512, 539, 619 Filter by Sample Highest Error 637
Export 127, 134, 140, 155, 158, 169, 339-341, 600, Filter by Sample ID 635
921 Filter by Sample On Board 638
Export a Definition 340 Filter by Sample Print Status 636
Export a Report 531, 616, 631, 782, 900 Filter by Sample Priority 635
Export a Test 340 Filter by Sample Status 637
Export Assigned Values 155 Filter by Sample Upload Status 635
Export Data 127, 339 Filter by Sample Validation Status 636
Export NPP Status List 503 Filter by Test Code 595, 640
Extended Acquisition Mode Extension 346 Filter in Use - Icon 922
Extended Acquisition Time 179, 196, 304 Filter Maintenance Activities 782, 787
Extended Acquisition Time - Rerun Rule 304 Filter Material List 132
Extended Jobs Counter 631 Filter QC Results 520-521
Extended Test - Icon 927 Filter Report Data 525
Extended Tests Counter 631 Filter Test List 158, 162
Extended Time 179, 246 Final Minus Initial Algorithm 240
External Communications Alarm - Icon 729, 921 Find 119, 594, 602
External Communications Alarm Error - Icon 921 Find - Icon 922
External Communications Alarm Warning - Icon 921 Find a Material 134
External Idle Position 86 Find a Test 161
Extrapolate Substitution Method 207 First and Second Derivative Algorithms 227, 929
First Concentration 266
F First Derivative 227, 929
Factor - Result Units 250 First Derivative Bound Check 218
Factor Parallelism 279-280 First Peak Boundary Check 218
Factor Parallelism - Criteria 280 Fluid Precision Test 882

Index
Fluid Precision Test Report 872 Head Volume Airgap 183, 192, 275
Fluid Waste 32, 402, 756 Help 1
Fluids 402, 872 Help - Icon 922
Focus 110-111, 590 Hold Time 150, 186, 793, 798, 801-807, 814
Foot and Probe Inspection 807, 831 Holding Area - LAS 560
Footer 377 Home Bar Code Reader - Icon 922
Formatting Reports 375 Hong Kong - IL Location 937
Forward Search Direction - Algorithm 225 Host Communications Configuration 354
France - IL Location 937 Host Configuration 355
Frequency 68, 105, 148, 186, 261, 298, 316-318, Host Downloading 354, 356
507, 519, 539, 788, 792, 797-815, 861 Host Uploading 354, 356
Futura Compatible Protocol 355 Hungary - IL Location 937
G I
General Consistency 468 Icons 920, 927, 929
General Feasibility 468 IL Corporate Headquarters 937
General Information - Tests 7, 168 IL Locations 937
General Log 104, 645, 900 IL Locked - Maintenance Setting 791, 793
General Log - Icon 922 IL Logo - Icon 922
General Log Button 900 IL Material/Test - Icon 927
General Log Detail Report 900 IL Revision Comment 171
General Log List Report 902 IL Test - Default Criteria 280
General Toolbar 98 IL Test - Test Setting 170
Germany - IL Location 937 IM - Interface Module Embedded System 86
Getting Started 81 Immunological Measurements 12
Global Definitions 344 Import - Icon 922
Glossary 82, 941 Import a Definition 339
Go to Test Definition - Icon 922 Import a Test 341
Graph Icons 929 Important Symbols 3
Greatest Max 218 Imported Calibration Unit 260
Greatest Max Peak Search Method 235 Imported Data Type 259
Greatest Max/Min Couplet 230 Imported Test 160-161, 164, 259, 342
Greatest Max/Min to Zero Couplet 218 Incubation Range 184
Grid Icons 927 Incubators 30, 85, 873, 898
Grid View - Icon 920 Indexer - Cuvette Loader 22, 83
Gripper 83 Indirect Delivery Mode 256
Indirect Test 12
H Information - Icon 927
Hamilton Syringe 843 Information Panel 92, 107
Hardware Components Version 887 Inherit LIS numbers from parent test 172
Hardware Events 886 Initialize All Arms 878
Hazards 4 INITIALIZING Status 104
Head Volume 182, 192, 275 Input Devices 78

INR Formula 153 LAS Configuration 363

INR Results - Reporting 139 LAS Cuvette Holding Area 86, 362, 420, 547, 560
INR Unit Data 252 LAS Manager 20, 86, 360
INR Value 153 LAS Overview 360
Insert Rack - Icon 922 LAS Position ID 606
Inserted Rack 388 LAS rack ID 606
Installing the ACL TOP 63 LAS Sample 21, 86, 125, 337, 345, 365, 473
Instrument Configuration - Icon 922 LAS Status 87, 105, 934
Instrument Decontamination 862 LAS Terminology 86
Instrument Description 14 LAS Track 17, 86-87, 360, 362, 412, 479, 570, 606,
Instrument Status 883 876
Instrument Temperatures 898 Last Concentration 266
Intended Use 8 Last Days 533
Interface Module Embedded System - IM 86 Last Execution Date/Time 789
Interference 4, 61, 243, 279 Last Max 218
Interleaved 2 of 5 - Setting 351 Last Max Peak 229
Intermediate Reagent 26, 85, 135, 143, 404 Last Max/Min Couplet 218, 230
ISI Value 133, 152-153, 250, 367, 393, 502, 523, Last Max/Min to Zero Couplet 218
581 Last Modification - Material Setting 153
Italicized Text Symbol 608, 612 Last Modification - User Security 373
Italy - IL Location 937 Last Points - QC Results 533
Latin America - IL Location 937
J Layout - UI 92
Japan - IL Location 937 Leaf with Error - Icon 927
Jaw - Cuvette Shuttle 83 Least Squares - Algorithm 218
Job Frequency Alarm 660 LED Status Color Codes 934
Job Frequency Alarm - Icon 922 Less Frequently Ordered Items 914
Job Type - Icon 927 Levey-Jennings Chart 535
Limit Value - Algorithm 224
Limitations and Disclaimers 74
K
Limited Warranty 64
Keyboard 14, 48, 53, 78
Linear - Result Units 249
Keypad 18
Linear Kinetic Algorithm 219
Known Material 88
Linear Regression - Calibration 263
Korea - IL Location 937
LIS - Laboratory Information System 79-80, 158, 163,
354
L LIS Configuration 354
Label - Result Units 248 LIS Host Alarms 645
Laboratory Header - Reports 376 LIS Number 170, 179, 197, 292
Language Setup 384 LIS Status 105, 934
LAS Adapters 414 Lithuania - IL Location 937
LAS Aliquoting Area 86 Load Cycle 179
LAS Arm 17, 86, 362-363, 798, 801, 806, 814, 825, Loading Racks 420
876 Location Information - Onboard Materials 147

Index
Locations 937 Material Identification 386

Lock a User 369 Material Index 136, 142
Lock Status - Icon 927 Material Information 388, 393, 505, 920
Locked Status Column 368 Material List 132
Log 104, 900 Material List - Icon 922-923
Log - Icon 922 Material Manufactured by IL 136
Log Details 645, 901 Material Name 142, 313, 315, 443, 461, 472
Log In 109 Material On-Board 132, 927
Log On Name 372 Material Onboard - Icon 927
Log Out 129 Material Programming Window 382
Log Report 900 Material Referenced 136
Login Name 372 Material Referenced - Icon 927
LOPD - Data Protection Organic Law 42 Material Restriction Map 132
Lot ID 136, 147, 152, 395, 443-444, 461-462, 512, Material Restriction Map - Icon 923
539 Material Status Enabled/Disabled - Icon 927
Lot Management 152, 155, 277, 337, 507, 518, 536, Material Threshold Alarm - Icon 923
565, 735
Material Threshold Alarm Error - Icon 923
Lot Selection 570
Material Threshold Alarm Warning - Icon 923
Lot Specific Comment 153
Material Type 142, 468-472
Low Fill Tubes Handling 348
Material/Sample Volume 183
Material/Test Tree View 920
M Material/Tests Definition Tree 515
Main Screen 93 Math Model 263, 283, 300, 487
Maintenance Activities 816 Math Model Low 263, 266, 487
Maintenance Alarm 662 Max 630
Maintenance Alarm - Icon 662, 922 Max Difference 249, 336
Maintenance Alarm Error - Icon 922 Max Tolerance 213
Maintenance Alarm Warning - Icon 922 Max Tolerance Warning 213
Maintenance Definitions 797 Max. Consecutive Dispensations 344, 348
Maintenance Overview 782 Max. Cuvettes per Dilution 348
Maintenance Schedule 779 Max. Peak Delta % Check - Algorithm 218
MAINTENANCE Status 104 Max. Peak Delta Check - Algorithm 218
Manual Material Identification 388 Max. Syringe Volume 344
Manufacturer 41, 142, 539 Maxima Peak Check - Algorithm 218
Master Paired Test 173 Maximum Error Limit - Algorithm 223
Material 88, 181, 386-387, 398, 400, 435, 443, 451, Maximum Warning Limit - Algorithm 223
461
Mean 630
Material Alarm 397-398, 400, 88
Mean Check 214
Material Alarm - Icon 923
Mean of 100% 281
Material Alarm Error - Icon 923
Mean of Calibration Point Replicates 300
Material Alarm Warning - Icon 923
Mean of Corrected Results - CR 281
Material Definition 132, 138
Mean of Corrected Results - CR 100% 282
Material Definition - Icon 922
Mean Value 491
Material Definition Report 140
Measured Parameters 11

Measured Result Curve Display Settings 249 No Tests - Icon 927

Measured Units 935 Non-IL Brand Product 75
Menu Bar 94 Non-IL Brand Product Disclaimer 69
Messages 645 Non-IL Reagents 69
Method 200, 207, 209, 212, 221, 253 Normal Jobs Counter 631
Mexico - IL Location 937 Normal Pool Plasma 298, 405, 501
Middle East - IL Location 937 Normal Range 164
Midpoint of Normal Range - NPP 300 Normal Test - Icon 927
Minima Peak Check - Algorithm 218 Normal Tests Counter 631
Minimum - Results Statistic 630 Normal, Therapeutic, Linear and Test Range 249
Minimum Aspiratable Volume 190, 273 Normalized Curve delta 212
Minimum Cuvette Volume for Mix 344, 348 Normalized Data Checks 211
Minimum Cuvette Volume for Test 348 NOT CONNECTED 104
Minimum r2 256 NOT FEASIBLE 608
Minimum Replicates 272 NOT FEASIBLE Status 154
Minimum Syringe Volume 347 Note - Symbol 3
Misuse 74 NPP 82, 132, 155, 173, 298, 337, 405, 407, 501,
Mix - Setting 183, 271, 273 506, 633
Mix Volume - Setting 183, 190, 273 NPP - Configuring 298
Mixture Volume - Setting 272 NPP - Derived from Calibration 300
Mode 1: Midpoint of Normal Range 298 NPP - Midpoint of Normal Range 300
Mode 2: User Input NPP Value 298 NPP - Normal Pool Plasma 82, 300, 405, 491, 501,
506
Mode 4: Derived from Calibration (Default) 298
NPP - Run as Sample 300
Monitor 37, 48, 50, 53, 80, 863
NPP - User Input NPP Value 300
Monitor Volume Control 37
NPP Counter 631
Monitor, Clean 863
NPP Details 501, 505-506, 777
Monotonic Check - Calibration 265
NPP Feasibility 470
Monthly and Quarterly Maintenance 779
NPP Feasibility - Icon 927
Most Frequently Ordered Items 913
NPP Jobs Counter 631
Mouse 78
NPP List Report 502-503
NPP Mode 298, 491, 506
N NPP Overview 125
Navigation Toolbar 99 NPP Results Report 503
Navigational Tree 166 NPP Status List 504
Neglect and Misuse 74 NPP Value 491
Nero Express Essentials 910 Number of Cycles 184, 191, 273
Netherlands - IL Location 937 Number of Dilutions 287, 293
New Scanned Data - 2D Bar Code 395 Number of Entries 107
Next Execution Date/Time 789 Number of Points - Algorithm 218
Next Rack - Icon 923 Number of Replicates 163, 179, 259, 293
Next Test Details - Icon 923 Number of Results 630
No Axis Transformation 491 Number of Seconds 201, 214
No Scrollable Columns 597

Index
Parallelism Result 280, 335, 620

O Parallelism Result Report 616
Off Line Rack 386, 434, 557, 576 Parallelism Setup 291
Offset 253 Parallelism Testing Options 280
Omit Point 523, 533 Parallelism Tests Counter 631
Omit Point - Icon 923 Parallelism Units 281, 294, 935
Omitted Point 929 Parameter Input 165
Onboard Racks 557 Parent Test 160, 172, 178, 197
Onboard Stability 146 Part Numbers 408, 913
Onboard Volume 443, 461 Partial Item/Test - Icon 927
Onboard Waiting for Volume - Icon 923 Parts and Consumables List 913
Open Calibration Status List - Icon 923 Password 109, 373
Open QC Results List - Icon 923 Patient Demographics 346, 561, 567, 589, 600, 611,
614, 923
Open Sample Details - Icon 923
Patient Demographics - Icon 923
Operating Principles 12
Patient Priority 344
Patient Report 170, 377, 587, 599-600
Optical Reading Unit - ORU 867
Patient Result 249, 335, 523, 587
Orange Bold - Text Symbol 608, 612
Patient Result Selection 249
ORU - Optical Reading Unit 31, 89, 867
Patient Samples 24, 48, 50, 53, 56, 349, 378, 544,
ORU Blanking Area 868 589
ORU Blanking Procedure 869 Patient Test - Icon 927
ORU Linearity Test 870 Patient Tests Counter 631
Other Alarms 739 Peak Checks - Algorithm 233
Output Devices 80 Peak Count Check - Algorithm 218
Peak Delta % Check - Algorithm 218
P Peak Delta Check - Algorithm 218
P/Ns 408, 913 Peak Search Method - Algorithm 218
Pacific Headquarters 937 Percentage of the Curve - Algorithm 226
Paired Result Data 252 Percentage of Time 209, 889
Paired Results Units 936 Perform Activity 787
Paired Unit 251 Perform Activity - Icon 924
Parallel Jobs Counter 631 Performing a Calibration 499
Parallelism 48, 50, 53, 163, 170, 279, 291, 304, 334, Performing a Normal Pool Plasma Measurement 506
347, 364, 469, 581, 611, 620, 640, 929, Performing a Quality Control Test 515
935
Performing Maintenance Activities 816
Parallelism - Icon 927
Piercer Probe Installation Procedure 858
Parallelism Definition 291
Piercer Probe Removal Procedure 856
Parallelism Detail 294, 611
Piercer/Probe Replacement 848
Parallelism Feasibility 469
Pivot Arm 83
Parallelism Feasibility - Icon 927
Place Focus 110, 590
Parallelism LIS Number 292
Placed Material 89
Parallelism Mode Extension 292, 347
PLACED Status 606
Parallelism Point Units 294
Plasma Collection 543
Parallelism Report 616

Plasma Separation 543 Probe 5, 29, 47, 49, 52, 86, 182, 191, 273, 347, 360,
Poland - IL Location 937 400, 402, 407-408, 426, 779, 791, 797, 817,
845, 848-849, 853, 856, 858, 862, 865, 878,
Popup Messages 740
914
Port Configuration 358
Probe and Seal Assembly Installation Procedure 853
Position in Rack 606
Probe and Seal Assembly Removal Procedure 849
Power Connector 17
Probe Coordinates Adjustment 876
POWER UP Status 104
Probe Replacement 848
Pre-Dilution - Diluent 188
Probe Syringe 30
Pre-Dilution - General 188
Profile 160, 321, 323-325, 327, 381, 517, 565, 575,
Pre-Dilution - Sample/Mixture 188 578
Preparation Cuvettes 87 Profiles List 321, 325, 327-328
Previous Rack - Icon 924 Program All Levels of QC 515
Previous Screen 122, 134, 138, 140, 158-159, 165- Program Material Placement 382
166, 168, 175-176, 188, 195, 198,
Program Tests and Profiles Placement 381
200, 204, 211, 218, 246-247, 256-
257, 291, 298, 304, 312, 314, 322, Programming a Bar Coded Sample 574
325, 327-328, 369, 486-487 Programming a Calibration 499
Previous Screen - Icon 924 Programming a Non-Bar Coded Sample 576
Previous Test Details - Icon 924 Programming a QC Profile 519
Primary Algorithm 218, 245, 251 Programming an NPP 506
Primary Unit 163, 249, 287, 294 Programming QC 515, 518, 520
Primary Unit Configuration 249 Progress Bar - Operations 128
Primary Wavelength 177, 198, 201 Purge Data 524
Print 123, 133, 155, 158, 162, 599, 787 Purple Bold - Text Symbol 608, 612
Print - Icon 924, 928 Push Buttons 79
Print a Calibration Report 488
Print a Results Statistics Report 628 Q
Print a Test Counters List Report 631 QC - Icon 928
Print an NPP List Report 502 QC Alarm - Icon 661, 924
Print an NPP Results Report 503 QC Alarm Error - Icon 924
Print Assigned Values 155 QC Alarm Warning - Icon 924
Print Maintenance List 783 QC Comment - Icon 928
Print Material List 133 QC Counter 631
Print Preview 134, 599 QC Feasibility 468, 546
Print Report 502, 616, 631 QC Feasibility - Icon 928
Print Report - Icon 924 QC Feasibility List 470, 546, 561
Print Screen 124, 134, 140 QC Jobs Counter 631
Print Status 605 QC List 155, 312, 314, 516
Print Test List 162 QC Material 89, 154, 312, 315, 513, 515
Printer 80 QC Omitted Point - Icon 928
Priority 21, 309, 344, 361, 404, 443-444, 461-462, QC Overview 509
557, 565, 584, 594, 605, 635, 775, 930
QC Point Number 538
Priority - Icon 928
QC Points 929
Priority Codes 570
QC Profile 325, 327, 517
Priority Status 362, 605

Index
QC Profiles List 325, 327-328 Reagent Color Codes 443, 445, 461, 463
QC Results - Icon 924 Reagent Diluent Area 450
QC Results List 511, 520 Reagent Incubator 30, 85
QC Results Status List Report 530 Reagent Rack 23, 434-435, 438, 440, 450-451, 453,
QC Setup Definition 314 457, 482-483, 755, 913
QC Statistic Report 531 Reagent Rack Details 443, 461
QC Statistics 511, 515, 521, 777 Reagent Racks, Diluent Racks and Bottle Adapters 915
QC Statistics Filter 533 Reagent Specifications 69
QC Status 315, 511, 539 Reagent Status Color Codes 932
QC Status Enabled/Disabled - Icon 928 Reagent Temperatures Area 871
QC Test Status List 513, 515 Reagents 14, 47, 50, 52, 69, 75, 82, 132, 139, 260,
404, 434, 436, 440, 444, 449-450, 457,
QC Tests Status Report 531
462, 545, 552
QC Tracking 522
Recalculate 198, 486-487, 502, 523, 581, 599
QC Tracking Information 522
Recalculate - Icon 924
Quality Controls 406
Recalculate Calibration 486-487
Query Point 88, 360
Recovery 482-483, 920
Red Bold - Text Symbol 608, 612
R Red X - Symbol 468
r2 149, 279, 490, 552, 823 Reference Readings 869
r2 Check 265, 279 Reference Readings Area 869
R4inse Solution System 14 Reference Section 919
Rack Details 386, 434-435, 449-451, 500, 506-507, Reflex Counter 631
518, 561, 565, 575-578 Reflex Definition 330
Rack Details - Icon 924 Reflex List 330
Rack ID 573, 585, 606, 616 Reflex Rules 330, 346
Rack Summary Information 573 Reflex Test 330, 927
Racks 23, 47, 49, 52, 134, 350, 361, 386-387, 390, Refresh 473, 645, 849, 853, 856, 858, 901
404, 406, 408, 410, 420, 426, 431, 435-436,
440, 445-446, 448-451, 457, 463-464, 518, Refresh - Icon 924
544-545, 561, 567-568, 576, 578, 665, 755, Refresh/Close 473
815-816, 819, 839, 841-842, 871, 913 Refrigeration 136, 147
Raw Data Checks 204, 245, 336 Remaining Stability 443, 445, 461, 463, 932
Raw Data Report 600 Repeat Delimiter 357
Reaction Curve 175, 209, 212, 225, 486, 501, 522, Replace CTS Filter and clean Clean Cup Area 808,
619 832
Reaction Curve - Icon 928 Replace CTS Piercer 808, 833
Reaction Cuvettes 397 Replace CTS Piercer/Probe 848
Reaction Information 494, 501, 776 Replace LAS Syringe 808, 833
READY Status 104 Replace LAS Syringe Tip 809, 833
Reagent and Diluent Map 434, 436, 449, 545 Replace Reagent 1 and 2 Syringe Tips 809, 833
Reagent Area 16, 48, 50, 53, 146, 185, 350, 404, 420, Replace Reagent 1 Syringe 809, 833
434-436, 440, 447-451, 457, 467, 545,
Replace Reagent 1 Syringe Tip 809, 833
819, 864, 868, 873
Replace Reagent 2 Syringe 810, 834
Reagent Area - Icon 924
Replace Reagent 2 Syringe Tip 810, 834
Reagent Arms 28

Replace Reagent Syringe 810, 834 428, 442, 459, 476, 552, 755, 779, 816-817,
Replace Reagent Syringe Tip 810, 834 862, 867, 878, 913, 934
Replace Sample Syringe 811, 834 Rinse After Mix 191, 273
Replace Sample Syringe Tip 811, 834 Rinse and Clean 31, 148, 185, 459, 552, 779, 862
Replace with Previous Value 207 Rinse Fluid 31, 398, 442, 459, 779, 934
Replacing the Syringe 843 Rinse Fluid Status 442, 459, 934
Replacing the Syringe Tip 843 Rinse Time 148, 184, 193, 275
Replicate 249, 259, 354, 491, 501, 572, 617, 621, Rinse Time After Mix 184, 186, 188
929 Rinse/Clean Priming Cycle for All Probes 811, 816,
Rerun 48, 50, 53, 147, 195, 304, 346, 361, 469, 585, 834
608, 612, 619, 632, 640 Rinse/Clean Priming Cycle for LAS Probe 812, 835
Rerun Counter 631 Rinse/Clean Priming Cycle for Reagent 1 Probe 812, 816,
Rerun Priority 309 836
Rerun Rules Setup 304, 585 Rinse/Clean Priming Cycle for Reagent 2 Probe 812,
836
Rerun Test - Icon 928
Rinse/Clean Priming Cycle for Reagent Probe 813,
Reset - Icon 924
837
Reset Counters 631
Rinse/Clean Priming Cycle for Sample Probe 813,
Restore 121, 140, 169, 176, 312, 314, 482-483, 487, 837
523, 600, 905, 908
Routine Clean for all Probes 798, 814, 817
Restore - Icon 924
Routine Clean for All Probes 838
Restore Point 523
Rrinse Solution System 151
Restriction Map 26, 133, 420, 546, 561
Rules 147, 160, 172, 304, 316, 330, 339, 346
Result Correlation Formula 253
Rules for Deleting a Test 160
Result Ranges 306
Run 23, 125-126, 344, 390, 438, 453, 480, 482, 499-
Result Unit 55, 245-246, 306, 313, 315, 330, 538, 500, 506-507, 517-518, 574-579
609, 612, 630
Run as Sample - NPP 300
Run Jobs - Icon 924
Result Unit Label 248
Run Multiple QC's 920
Result Unit to Test 306
Run Optimization 344
Results 502, 520, 602
Run Tests 126, 546, 561, 566
Results from Selected Jobs 630
Russia - IL Location 937
Results Inside Normal Range 629
Results Statistics 601, 628
Results Statistics Filter 629
S
Safety 4, 16, 64, 74, 351
Results Statistics Report 628
Safety Covers 14, 755
Resume Auto Run 479, 481
Sample 82, 407, 436, 449, 451, 467, 500, 507, 518,
Retry - Button 396
544-545, 560, 565-566, 574-579, 582-583,
Return to Previous Screen 544 589, 592-593, 611, 615, 621, 775-776
Review 140, 486, 599 Sample Area 47, 50, 52, 351, 381, 407, 420, 436,
Reviewing QC Results 520 449, 451, 467, 499-500, 506-507, 515,
Reviewing Sample Status 580 518, 544-545, 548, 557, 560, 565, 574-
579, 873
Reviewing Test Results 581
Sample Area - Icon 925
Revision History Report 338
Sample Area Toolbar 566
Rinse 18, 138, 184, 191, 273, 398, 402, 422-423,
Sample Arm 20, 406, 426, 848

Index
Sample Aspiration Time 87, 365 Scheduled Material 82

Sample Collection and Storage 543 SCHEDULED Status 589
Sample Containers and Adapters 408 Scrollable Columns 597
Sample Details 381, 566, 580, 582-583, 589, 592- SD - Standard Deviation 630
593, 611, 615, 621, 775-776 SD Check 214
Sample Details - Icon 925 SD Error Limit 222
Sample Expiration Time 87, 337, 361, 365 SD Value 538
Sample Highest Error 605, 637, 775 SD Warning Limit 222
Sample Highest Error - Icon 927 Search Direction - Algorithm 225
Sample ID 323-324, 356, 407, 500, 507, 518, 556, Second Derivative - Algorithm 228, 929
570, 576, 582-584, 589, 592-594, 602,
Secondary Algorithm 245, 262
611, 621, 635
Security Level 75, 107, 159, 166-167, 174, 367-368,
Sample Incubator 30, 85
370-372
Sample Information 920
Select 111, 113, 135, 163, 248, 324, 368, 517, 519,
Sample Life 346 538, 590, 595
Sample List 110, 248, 354, 379, 547, 566, 580-586, Select QC Profiles 517, 519, 533
587-597, 611, 615-616, 621, 634, 775-
Select QC Profiles - Icon 925
776, 925
Selected Item/Test - Icon 928
Sample List Display Settings 111, 379, 582, 584, 591-
592, 594, 596-597, 602, Selected Reflex Test List 330
605, 775 Selecting Objects 113
Sample List Display Settings - Icon 925 Selection Column - Icon 928
Sample List Filter 602, 634 Sender 359, 607
Sample On Board 589, 638 Sender List 359
Sample Onboard - Icon 928 Sensor 934
Sample Pre-Dilution 188, 267, 293 Serial Number 9, 348, 905
Sample Rack Details 500, 506, 518, 565, 618 Set LAS Aspiration Point 876
Sample Rack Details Toolbar 567 Set of Filters 1 - Sample List 635
Sample Racks and Adapters 915 Set of Filters 2 - Sample List 637
Sample Result Report 589 Set of Filters 3 - Sample List 639
Sample Status 125, 361, 556, 580, 605, 609, 612, Set Statistic as Target 533
637, 930 Set Statistic as Target - Icon 925
Sample Status - Icon 928 Setup Alarms 735
Sample Status Color Codes 556, 605, 930 Setup Language 384
Sample Tube Queue 20, 88, 362 Shadow Test 172, 178, 291
Sample Type 89, 500, 507, 518, 569 Shock Hazard 4
Sample/Mixture 192, 197 show or Add Comments 927
Sarstedt Rack 410, 431, 917 Show or Add Comments 522
Save 120, 141, 176 Show Reaction Curve - Icon 925
Save - Button 396 Shutting Down the Instrument 477
Save - Icon 925 Single Dilution 270, 280, 293
Scale +/- 537 Site Requirements 64
Scan 133, 388, 390, 393 Size of Window - Setting 209
Scan - 2D Bar Code 132 Slope 220, 251, 259, 279, 295, 490, 935
Scan Material Data - Icon 925 Slope Check 223, 263, 285, 295, 490

Slope of Curve 220

Smallest Volume 144 T
Smoothing 202, 218 Target Mean 157, 313, 511, 538
Software Access Screen 159, 370-371, 374 Target SD 313, 511, 538
Software Version 871, 886, 908 Target Value 263
Sorting Lists 117, 589 Target Value % 256
Spain - IL Location 937 TCP/IP Configuration 358, 366
Spatial Requirements - TOP Instrument 65 Temperatures Area 869, 898
Specifications - ACL TOP Models 45, 47, 49, 52 Terminology 82
Standard Deviation - SD 630 Terms - Commonly Used 1, 82
Standard Factor - Parallelism 280 Test & Unit Column - Result Statistics 630
Standard Test Profile 323-324 Test Cell - LAS 564
Standard Time - Analytical Cycle 177 Test Code 159, 170, 179, 197, 292, 313-314, 330,
Start Reagent 28, 89, 135, 143, 404 354, 472, 498, 511, 513, 572, 590, 616,
Start Reagent - Icon 928 628, 631, 640
Start the TOP Instrument 475-476, 482 Test Code and Rerun - Filter 640
Start Time - Algorithm 220 Test Consistency - Icon 928
Stat 48, 50, 53, 360, 546, 561, 565, 570, 575, 577- Test Counter Statistics - Detailed 631
579, 605, 635 Test Counter Statistics - Simple 631
Stat - Icon 927-928 Test Counters List Report 631
Stat Indicator 570 Test Counters Statistics 601, 631
Statistic Mean 511, 537 Test De-selection 566
Statistical Units 251, 936 Test Definition 158, 165, 168, 175, 345
Statistics Algorithm 243 Test Details 586, 611, 615, 621, 776
Statistics Start Time - Algorithm 243 Test Details - Icon 923, 925
Statistics Time - Algorithm 243 Test Enabled/Disabled 164, 313
Status Bar 104, 753 Test Feasibility 260, 315, 467, 534
Status List - Icon 924 Test Feasibility List 467, 534, 546, 561
Stirring 136, 147, 434, 450, 755 Test Filters - Sample List 640
Stirring - Icon 928 Test Information 612
Stirring Required - Material Setting 149 Test is a Rerun - Icon 928
Stop an Operation 128 Test Leaf - Icon 928
Stop the TOP Instrument 475, 477-479 Test List 139, 158-161, 165-166, 168, 175-176, 188,
Storage - TOP Instrument 68 195, 198, 200, 204, 211, 218, 246, 256-257,
291, 298, 304, 311, 467, 566, 622
Symbols 9
Test List - Icon 921, 925
Syringe 30, 347, 407, 417, 780, 791, 808, 833, 914
Test List Actions Menu 162
System Capacities 349
Test List Show/Hide - Icon 928
System Decontamination 862
Test Mode Extensions 346
System Fluids – Rinse and Clean 31
Test Modification Number 171
System Identification - Setting 348
Test Name 159, 170
System Security 107, 367
Test Number 170, 782
System Specifications 44
Test Performance 55
System Versions 886
Test Profile 160-161, 164, 321, 323-324

Index
Test Profile Name 324

Test Profiles Definition 321 U
Test Profiles List 321 UI - ACL TOP 77
Test Programming Window 379, 381, 500, 507, 591 UK - IL Location 937
Test Result Units 246 Underlined - Text Symbol 608, 612
Test Selection 570 Unidentified Material 89, 387
Test Triggered a Rerun - Icon 928 Unit 163, 246, 259, 280, 294, 306, 313, 315, 330,
Test/Material Tree View - Icon 925 511, 529, 609, 612, 616, 628
Test/Materials Definition Tree 515 Unit Selection 250
Tests and Profiles Window 572, 604 Unit Type 248
Therapeutic Test Results 249 United Kingdom - IL Location 937
Third Party Products 74 Units 280, 598
Threshold Algorithm 224 Universal Arm 881
Throughput 14, 47, 49, 345, 364, 563 Unlocking a User 370
Throwaway Material 144 Upload 539, 581, 583-584, 589, 593-594, 602
Time 47, 49, 53, 184, 219, 317-319, 365, 512 Upload - Icon 925
Time to Completion 107, 126, 610 Upload Status 539, 583-584, 593-594, 606, 618, 635
TODO - Status 589 Upload Status - Icon 928
Toggle Lot - Button 396 USA - IL Location 937
Toggle Standard Profile - Icon 323 User-Defined Label 1, 252
Tolerance 213, 244, 264, 295 User-Defined Test 159-160, 166, 175, 195, 198, 485
Toolbar 98 User-Defined Tests 75, 170, 175, 196, 204, 218, 287,
Toolbar Icons 920 293
Total Cuvette Volume 180 User - Icon 925
Total Number of Jobs 633 User Input NPP Value 300
Total Volume 150, 183 User Interfaces 77
Touch Screen 14, 37, 48, 50, 53, 65, 78, 863 User Locked - Security 373
Track Control Panel 558, 577 User Name 109, 372
Tracking Information 495, 505, 617, 815-816, 819, User Revision Comment 171
839, 841-842 User Security List 368-372
Training Requirements 72
Transport 20, 74, 83 V
Transport Airgap 150, 183, 192, 275, 793 Valid Period - User Security 373
Tree View 520 Validate 111, 142, 259, 298, 334, 485-486, 500, 581-
Trend Check 265 582, 589-590, 592, 602
Trend Line 537, 929 Validate - Icon 925
Troubleshooting Alarm Messages 645 Validate a Calibration 272, 486
Troubleshooting Other Problems 755 Validated Sample Tubes 407
Tubes 17, 21, 47, 52, 348, 351, 360, 364-365, 390, Validation and Upload 589
408, 410, 426, 431, 755 Validation Status 488, 505, 582, 584, 592, 594, 605,
Typical Linearity 61 616, 636
Typical Method Comparison 56 Validation Status - Icon 928
Typical Precision Performance 55 Variance Check 285, 297
Versions 197, 886, 899

Vial Lists 131 Warning Threshold - Icon 925

View 77, 115, 138-139, 155, 158, 165, 176, 180, Warnings and Errors 443, 445, 461, 463
246, 272, 291, 298, 312, 321, 328, 467, 499, Warranty 69, 73, 75
501, 515-516, 519, 521-522, 533, 535, 538,
Warranty Claims 74
580, 615, 628
Washed Cuvettes 75
View a Maintenance Activity 790
Waste Bin 84
View a Material Definition 133
Waste Container 33, 84, 402, 817, 862, 914
View a QC Profile 325, 327
Waste Cuvette 85
View a Reaction Curve 522
Waste Drawer 16, 85, 397, 779, 798, 817, 862
View a Test Definition 158, 165
Waste Fluid Status 442, 459, 934
View Active Lot Data 533
Wavelength Definition 200
View an Item 115
Weekly Maintenance 779
View an Item - Icon 925
Welcome to Help 1
View Assigned Values 155
Wipe-Down All Probes 839
View Calibration Status List Information 497
Wipe-Down Reagent Probes 841
View Chart Information 521
Wipe-Down Sample Probe 842
View Material Details 312
Wipe Down All Probes 814
View QC Results 533
Wipe Down LAS Probe 814, 840
View QC Results List 511, 520
Wipe Down Reagent Probes 815
View QC Test Status List 513
Wipe Down Sample Probe 815
View Result Unit Details 246
Working Area 102
View Test Details 615
WRange 244
Virtual Rack 388, 446
Virtual Sample Tube Queue 88
Visual Style - User Interface 91 X
Volt-Amps Specifications 64 X-Axis Transformation 264, 488
Voltage Requirements 68
Voltages 865, 880 Y
Volume - Monitor 37 Y-Axis Transformation 265, 488
Volume Tracking 143, 145 Y-Intercept 263, 284, 490
Yellow Number Symbol 468
W
Waiting for On-Board Material Volume 927
Waiting for Onboard Material Volume - Icon 928
WARMING UP Status 104
WARNING 3-4, 398, 400, 860
Warning - Icon 928
Warning Alarms 645, 753
Warning Data Flags 757
Warning Limit 222
Warning Limit and Tolerance 244
Warning Period - User Security 373
Warning Threshold 261, 302, 317-318, 787, 790-791,
793-794, 860

Index

Version 5.0.1 ACL TOP Operators Manual EN

Uploaded by

Copyright:

Available Formats

Version 5.0.1 ACL TOP Operators Manual EN

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Version 5.0.1 ACL TOP Operators Manual EN

Uploaded by

Copyright:

Available Formats

ACL TOP Family Operator's Manual

Help ♦ Version 5.0.1 ♦ P/N 29244915 R01 ♦ 2011

Manufacturer EU Authorized Representative

®ACL TOP is a registered trademark of Instrumentation Laboratory Co.

Instrumentation Laboratory Company i

ii Instrumentation Laboratory Company

Instrumentation Laboratory Company iii

Deleting an Item 116

iv Instrumentation Laboratory Company

Deleting a Test Definition 160

Instrumentation Laboratory Company v

vi Instrumentation Laboratory Company

Configuring Factor Parallelism 279

Instrumentation Laboratory Company vii

Creating a Reflex Rule 330

viii Instrumentation Laboratory Company

User Security List screen 368

Instrumentation Laboratory Company ix

x Instrumentation Laboratory Company

Instrumentation Laboratory Company xi

NPP Status List Screen 504

xii Instrumentation Laboratory Company

Sample Area 544

Instrumentation Laboratory Company xiii

Adding and Removing Tests Associated with a Sample 591

xiv Instrumentation Laboratory Company

Analyzer Status Indicators 643

Instrumentation Laboratory Company xv

Adding a Maintenance Activity 790

xvi Instrumentation Laboratory Company

Wipe Down Reagent Probes 815

Instrumentation Laboratory Company xvii

Hamilton Syringe Procedures 843

xviii Instrumentation Laboratory Company

Viewing the Fluid Precision Test screen 882

Instrumentation Laboratory Company xix

Reagent Placement 932

xx Instrumentation Laboratory Company

Instrumentation Laboratory Company 1

2 Instrumentation Laboratory Company

WARNING: Warning statements provide information about electrical hazards

NOTE: Note statements contain important user information.

BIOHAZARD: Biohazard statements alert you to potentially biohazardous conditions.

Instrumentation Laboratory Company 3

WARNING Piercing Hazard:

4 Instrumentation Laboratory Company

Instrumentation Laboratory Company 5

6 Instrumentation Laboratory Company

General Information Overview

Instrumentation Laboratory Company 7

8 Instrumentation Laboratory Company

Caution: Risk of Danger { IEC 61010.1 }

Note: Important User Information

Attention: Consult Instructions for Use

In Vitro Diagnostic Device

Contains sufficient for <n> tests

Protective Conductor Terminal - Earth

Instrumentation Laboratory Company 9

Bar Code Reader Hazard

Stop Action – Instrument stops all moving parts immediately