RX Daytona Operator Manual v2.0 Sept 2009

FOREWORD Version 2.
0 Rev September 2009
FOREWORD
RX Daytona is an automated clinical chemistry analyser complete with dedicated
analyser software. Software functions of the analyser include the facility to interact
with a host computer for direct download of test method selection details for individual
samples. A barcode system is used for the rapid identification and management of
patient samples, reagents and QC samples.
The RX daytona analyser is an “in vitro diagnostic (IVD) medical device” and
conforms to the IVD directive (98/79/EC) and the EMC directive (89/336/EEC) of the
EU. The RX daytona has been evaluated to Canadian safety requirements.
C lin ic a l
C h e m is tr y
A n a ly s e r
3X A6
The RX daytona operator manual is written for use by personnel that have completed
the RX daytona training course, or those that have been fully trained by individuals
that have attended the course. The aim of the manual is to familiarise the user with all
the features and functions of the analyser to ensure analysis is performed under safe
and optimal conditions.
This manual was produced for PC130 version of the RX Daytona software.
©2009 by Randox Laboratories Ltd,. 55 Diamond Road, Crumlin,

Co Antrim, BT29 4QY, United Kingdom.
All rights reserved. No part of this publication may be reproduced, stored

in a retrieval system, or transmitted in any form or by any means,
electronic, mechanical, photocopying, microfilming, recording or
otherwise without the written permission of the publisher.
For Technical Support contact Randox Laboratories on:

Tel: +44 (0)28 9445 1070
E-mail: rxsupport@randox.com
Page I
FOREWORD Version 2.0 Rev September 2009
Page II
TABLE OF CONTENTS Version 2.0 Rev September 2009
FOREWORD .....................................................................................................I
TABLE OF CONTENTS .......................................................................................III
SECTION 1 SAFETY PRECAUTIONS AND INSTALLATION........................1
1.1 WARNING SYMBOLS ..............................................................................2
1.2 WARNING LABELS ..................................................................................3
1.3 WARNINGS FOR SAFE USE ...................................................................5
1.4 SAFETY PRECAUTIONS .........................................................................6

1. 4. 1 Prevention of System Damage ................................................6
1. 4. 2 Prevention of Electric Shocks ..................................................6
1. 4. 3 Prevention of Personal Injury ...................................................6
1. 4. 4 System Accuracy and Precision...............................................6
1. 4. 5 Waste Liquids...........................................................................7
1. 4. 6 Prevention of Infection .............................................................7
1. 4. 7 Reagent Handling ....................................................................7
1. 4. 8 General Precautions ................................................................7
1. 4. 9 Emergency Shutdown Procedure ............................................8
1.5 INSTALLATION REQUIREMENTS...........................................................9

1. 5. 1 Recommended Installation Environment .................................9
1. 5. 2 Installation Precautions ............................................................9
1. 5. 3 Transport and Storage Conditions ...........................................10
1. 5. 4 Operational Precautions...........................................................10
1.6 TECHNICAL SPECIFICATIONS...............................................................11
1.7 SYSTEM CONFIGURATION AND EQUIPMENT LIST.............................15
1.8 EQUIPMENT LIST ....................................................................................16
Page III
SECTION 2 SYSTEM OVERVIEW ..................................................................19
2.1 ANALYSER OVERVIEW...........................................................................20

2. 1. 1 Reagent Management (RCU scan)..........................................21
2. 1. 2 Preparation...............................................................................22
2. 1. 2. 1 Initialisation of Hardware.........................................22
2. 1. 2. 2 Lamp Gain Optimisation..........................................22
2. 1. 2. 3 Prime.......................................................................22
2. 1. 2. 4 Sample Barcode Label Scan (barcode mode
enabled) ..................................................................22
2. 1. 3 First Reagent Measurement.....................................................22

2. 1. 3. 1 First Reagent Dispense...........................................22
2. 1. 3. 2 Sample Dispense ....................................................22
2. 1. 3. 3 Mixing......................................................................22
2. 1. 3. 4 Measurement of Absorbance (1 - 13) .....................23
2. 1. 4 Second Reagent Measurement ...............................................23

2. 1. 4. 1 Second Reagent Dispense .....................................23
2. 1. 4. 2 Mixing......................................................................23
2. 1. 4. 3 Measurement of Absorbance (14 - 26) ...................23
2. 1. 5 Wash ........................................................................................23
2. 1. 6 Emergency Stop.......................................................................23
2. 1. 7 Automatic Rerun ......................................................................24
2. 1. 8 Reagent Blank Measurement ..................................................24
2. 1. 9 Water Blank Measurement (Cuvette Check)............................24
2. 1. 10 ISE Measurement ....................................................................24
2.2 SYSTEM COMPONENTS.........................................................................25

2. 2. 1 Autosampler Unit (ASP) ...........................................................25
2. 2. 1. 1 Turntable .................................................................26
2. 2. 1. 2 Barcode Reader ......................................................26
2. 2. 2 Reagent Container Unit (RCU) ................................................27

2. 2. 2. 1 Reagent Bottles.......................................................27
2. 2. 2. 2 Reagent Tray ..........................................................28
2. 2. 2. 3 Cooler......................................................................29
2. 2. 3 Sample Pipette Unit (SPT) .......................................................29

2. 2. 3. 1 Level Sensor ...........................................................29
2. 2. 3. 2 Lower Limit Sensor .................................................30
2. 2. 3. 3 SPT Trough.............................................................30
2. 2. 4 Reagent Pipette Unit (RPT) .....................................................30

2. 2. 4. 1 Level Sensor ...........................................................31
2. 2. 4. 2 Lower Limit Sensor .................................................31
2. 2. 4. 3 RPT Trough.............................................................31
Page IV
2. 2. 5 Incubation Reaction Unit (IRU) ................................................31

2. 2. 5. 1 Cuvette Holder ........................................................32
2. 2. 5. 2 Temperature Sensor and Heater ............................32
2. 2. 6 Detector Unit (DTR) .................................................................32

2. 2. 6. 1 Photometer..............................................................32
2. 2. 7 Stirring Unit (MIX-1 & MIX-2) ...................................................33

2. 2. 7. 1 MIX-1.......................................................................33
2. 2. 7. 2 MIX-2.......................................................................33
2. 2. 8 Wash Unit (WU) .......................................................................33
2. 2. 9 Pump Unit ...............................................................................35

2. 2. 9. 1 Pumps .....................................................................35
2. 2. 9. 2 Syringes ..................................................................36
2. 2. 9. 3 Solenoid Valve ........................................................37
2. 2. 10 Electrolyte Measurement Unit (ISE Option) .............................37
2.3 SOFTWARE OVERVIEW .........................................................................40

2. 3. 1 Keyboard Layout ......................................................................40
2. 3. 2 Menu Structure.........................................................................43
2.4 SCREEN LAYOUT....................................................................................44

2. 4. 1 Job Menu ................................................................................44
2. 4. 2 Global Menu.............................................................................44
2. 4. 3 Function Keys ..........................................................................45
2. 4. 4 Equipment Status.....................................................................45
2. 4. 5 Menu Description .....................................................................46
2. 4. 6 Page Number ...........................................................................46
2. 4. 7 STAT Information .....................................................................46
2. 4. 8 Shutdown Button......................................................................46
Page V
SECTION 3 SYSTEM PREPARATION AND ROUTINE ANALYSIS ..............47
3.1 PREPARATION FOR ANALYSIS .............................................................48

3. 1. 1 Initialisation Of Hardware .........................................................48
3. 1. 1. 1 Maintenance Summary ...........................................49
3. 1. 2 System Initialisation and Prime ................................................51

3. 1. 2. 1 Automatic Initialisation ............................................51
3. 1. 2. 2 Manual Initialisation.................................................51
3. 1. 2. 3 System Prime..........................................................51
3.2 GENERAL OPERATING PROCEDURE...................................................55

3. 2. 1 Load Reagent/ Diluents And Wash Solutions ..........................56
3. 2. 2 Registration Of Reagents, Diluents And Wash Solutions ........56

3. 2. 2. 1 Registration of Barcoded (closed channel) Bottles .56
3. 2. 2. 2 Registration of Open Channel Barcoded Bottles ....59
3. 2. 3 Register Calibrators, Controls And Patient Samples ...............61

3. 2. 3. 1 Calibration Type ......................................................61
3. 2. 3. 2 Calibration for Different Reagent Lots.....................62
3. 2. 3. 3 Defining Calibrator Concentration ...........................62
3. 2. 3. 4 K Factor...................................................................64
3. 2. 3. 5 Recalculation of Results..........................................65
3. 2. 3. 6 Definition of Calibrator Conditions of Measurement66
3. 2. 3. 7 Measurement of Reagent Blank During Run ..........68
3. 2. 3. 8 Quality Control Samples .........................................73
3. 2. 4 Test Selection For Barcoded Patient Samples ........................77

3. 2. 4. 1 Normal / Replicate Sample Test Selection..............78
3. 2. 4. 2 Copying Test Selections for Barcoded Samples.....80
3. 2. 4. 2. 1Copying Test Selection for Normal
Sample ...................................................80
3. 2. 4. 2. 2Copying Test Selection for Replicate
Sample ...................................................80
3. 2. 4. 3 Deleting Test Selections for Barcoded Samples.....81
3. 2. 4. 4 Masking Option (Barcoded and Non Barcoded
Samples) .................................................................81
3. 2. 4. 5 Confirmation of Test selections...............................84
3. 2. 4. 6 Calibration and Control expiry alarm.......................85
3. 2. 5 Loading Calibrators, Controls And Barcoded Patient

Samples ...................................................................................86
3. 2. 5. 1 Sample Tubes .........................................................86
3. 2. 5. 2 Sample Cups...........................................................86
3. 2. 5. 3 Paediatric Cups.......................................................87
3. 2. 5. 4 Sample Barcodes....................................................87
3. 2. 5. 4. 1Specifications of Sample Barcode
Label .....................................................88
Page VI
3. 2. 5. 4. 2Types of Barcode Label ........................89

3. 2. 5. 4. 3Information on Sample Barcode............90
3. 2. 5. 4. 4 Label Error Check of Sample Barcode.93
3. 2. 6 Test Selection For Non-barcoded Patient Samples .................93

3. 2. 6. 1 Enter Information for Non-barcoded Samples.........93
3. 2. 6. 2 Copying Test Selections for Non-barcoded
Samples ..................................................................97
3. 2. 6. 3 Deleting Test Selections for Non-barcoded
Samples ..................................................................98
3. 2. 6. 4 Confirmation of Test selections...............................98
3. 2. 6. 5 Calibration and Control Expiry Alarm ......................99
3. 2. 6. 6 Cautions in Making Test Selections (non-barcode
mode only) ..............................................................99
3. 2. 6. 7 Masking Procedure .................................................100
3. 2. 7 Loading Calibrators, Controls And Non-barcoded Patient

samples....................................................................................100
3. 2. 7. 1 Sample Tubes .........................................................100
3. 2. 7. 2 Sample Cups...........................................................100
3. 2. 7. 3 Paediatric Cups.......................................................101
3.3 START ANALYSIS....................................................................................102

3. 3. 1 Monitoring Measurement Progress ..........................................103
3. 3. 2 Finish Analysis .........................................................................105
3. 3. 3 System Alarms .........................................................................105
3. 3. 4 Analyser Shut Down.................................................................106
3. 3. 5 Restart Analysis .......................................................................109
Page VII
SECTION 4 ACCESSORY FUNCTIONS.........................................................111
4.1 INTERRUPTION OF MEASUREMENT ....................................................112

4. 1. 1 Emergency Stop.......................................................................112
4. 1. 2 Interruption Of Sampling ..........................................................112

4. 1. 2. 1 Sample Interruption to Load Emergency Samples..112
4. 1. 2. 1. 1Emergency Sample Addition
(barcode disabled) .................................113
4. 1. 2. 1. 2Emergency Sample Addition
(barcode enabled) ..................................114
4. 1. 2. 2 Sample Interruption to Load Normal Samples ........116
4.2 SAMPLE RE-RUNS ..................................................................................120

4. 2. 1 Automatic Re-runs ...................................................................120
4. 2. 2 Result Outside The Measuring Range .....................................120

4. 2. 2. 1 Sample Re-run Without Dilution..............................120
4. 2. 2. 2 Sample Re-run with Dilution....................................121
4.3 CALIBRATION ..........................................................................................122

4. 3. 1 Standards.................................................................................122
4. 3. 2 Standard Series (SS) ...............................................................122
4. 3. 3 Register Multi-calibrator Details (MS) ......................................125
4.4 OPERATIONAL CONDITIONS AND PARAMETERS...............................127

4. 4. 1 Analytical Conditions (Chemistry Parameters) Page 1 of 2 .....128
4. 4. 2 Serum Indices ..........................................................................138
4. 4. 3 Method To Method Calculation ................................................143
4. 4. 4 Test Profile ...............................................................................144
4. 4. 5 Testing Order and Result Printout Order .................................145

4. 4. 5. 1 Testing Order ..........................................................145
4. 4. 5. 2 Result Printout Order ..............................................146
4. 4. 6 Entry Of System Parameters ...................................................147

4. 4. 7 Data Backup.............................................................................153
4. 4. 8 Test Selection When Connected To Host Computer ...............157
4. 4. 8. 1 Test Selection for Sample in On-line Batch
Mode 1 and 2 ..........................................................157
4. 4. 8. 2 Confirmation of Test Selection ................................158
4. 4. 8. 3 Test Selection for Sample in On-line Real Time
Mode .......................................................................159
4. 4. 8. 4 Cautions in Using On-line Real Time Mode ............159
4. 4. 8. 5 Switch Off Host Communication Mode ...................159
Page VIII
4. 4. 9 Entering Patient Information Details.........................................159

4. 4. 9. 1 Entering Patient ID Number ....................................160
4. 4. 9. 2 Entry of Ordering Physician, Attending Physician
and Referral Physician Details ................................162
4. 4. 9. 3 Entry of Location, Phlebotomist and Race ..............162
4. 4. 9. 4 Entry of Patient ID at Test Selection .......................163
Page IX
SECTION 5 RETRIEVAL OF RESULTS .........................................................165
5.1 AUTOMATIC PRINTOUT OF RESULTS ..................................................166
5.2 RETRIEVAL OF STORED RESULTS.......................................................167

5. 2. 1 Retrieval Of Calibration Curves................................................169
5. 2. 1. 1 Retrieval of Non-ISE Calibration .............................169
5. 2. 1. 2 Retrieval of ISE Calibrations ...................................171
5. 2. 2 Retrieval of Results by Patient ID ............................................172

5. 2. 3 Viewing a Time Course ............................................................173
5.3 RETRIEVAL OF QUALITY CONTROL VALUES ......................................175

5. 3. 1 Graphic Display........................................................................175
5. 3. 2 Measurement Values ...............................................................177
5. 3. 3 QC Settings..............................................................................179
5. 3. 4 Control Types...........................................................................179
5.4 RESULTS FLAGS AND ERROR FLAGS .................................................181
5.5 EXAMPLES OF RESULTS PRINTOUTS .................................................184
Page X
SECTION 6 MAINTENANCE...........................................................................191
6.1 MAINTENANCE INTERVALS ...................................................................192

6. 1. 1 Daily Maintenance....................................................................194
6. 1. 2 Weekly Maintenance................................................................195
6. 1. 3 Monthly Maintenance ...............................................................195
6. 1. 4 Periodic Maintenance...............................................................196
6.2 MAINTENANCE SCREEN ........................................................................197

6. 2. 1 System Checks ........................................................................197
6. 2. 1. 1 Initialisation .............................................................198
6. 2. 1. 2 Prime Sequence......................................................198
6. 2. 1. 3 Short Prime Sequence ............................................198
6. 2. 1. 4 Cuvette Check.........................................................198
6. 2. 1. 5 Pump Test...............................................................198
6. 2. 1. 6 Cuvette Wash..........................................................199
6. 2. 1. 7 Cuvette Water Placement .......................................199
6. 2. 1. 8 Cuvette Water Displacement ..................................199
6. 2. 1. 9 WU1, 3 Rinse ..........................................................199
6. 2. 1. 10 ISE Prime ................................................................199
6. 2. 1. 11 ISE Cleaning ...........................................................199
6. 2. 1. 12 ISE Calibration ........................................................200
6. 2. 1. 13 Sensor Tests ...........................................................200
6. 2. 2 Washing Procedures................................................................202
6. 2. 2. 1 SPT .........................................................................203
6. 2. 2. 2 SPT(S) ....................................................................203
6. 2. 2. 3 RPT(W) ...................................................................204
6. 2. 2. 4 RPT(C) ....................................................................204
6. 2. 2. 5 RPT(S) ....................................................................204
6. 2. 2. 6 SPT/RPT(W) ...........................................................205
6. 2. 2. 7 SPT/RPT(C) ............................................................205
6. 2. 3 Tubing Wash ............................................................................205
6. 2. 4 Cuvette Check..........................................................................207
6. 2. 4. 1 Wavelength .............................................................207
6. 2. 4. 2 Date (Date of measurement)...................................208
6. 2. 4. 3 Judgement Value ....................................................208
6. 2. 4. 4 Accepted Result ......................................................208
6. 2. 5 Working Hours Of Expendable Parts .......................................208

6. 2. 6 Method To Method Wash.........................................................209
6. 2. 7 Performance Check Facility .....................................................213
6. 2. 8 Autostart...................................................................................214
6. 2. 8. 1 Time and Settings ...................................................217
6. 2. 8. 2 Preparation for Autostart .........................................217
Page XI
6. 2. 9 Cleaning Procedures................................................................218
6. 2. 9. 1 Cleaning External Tanks .........................................218
6. 2. 9. 2 SPT or RPT.............................................................218
6. 2. 9. 3 Cleaning the WU Nozzles .......................................219
6. 2. 9. 4 Mix-1/Mix-2 (Stirring Paddles).................................220
6. 2. 9. 5 Water Supply System..............................................220
6. 2. 9. 6 Cuvette....................................................................221
6. 2. 9. 7 Sample Compartment (ASP)...................................221
6. 2. 9. 8 Reagent Compartment (RCU).................................221
6. 2. 9. 9 Mosaic Plate............................................................222
6. 2. 9. 10 Dust Filter................................................................223
6. 2. 10 Parts Replacement...................................................................223
6. 2. 10. 1 Syringe Tip Replacement........................................223
6. 2. 10. 2 Stirrer Replacement (Mix-1/Mix-2) ..........................224
6. 2. 10. 3 Pipette Replacement (SPT/RPT) ............................224
6. 2. 10. 4 Replacement of Halogen Lamp...............................226
Page XII
SECTION 7 TROUBLESHOOTING.................................................................229
7.1 TROUBLESHOOTING ..............................................................................230

7. 1. 1 Analytical Problems..................................................................230
7. 1. 2 Equipment Problems................................................................230
7.2 MALFUNCTION AT POWER ON..............................................................231
7.3 ANOMALOUS RESULTS..........................................................................232

7. 3. 1 Check Reagents, Calibrators, QC And Patient Samples .........232
7. 3. 2 High Values..............................................................................234
7. 3. 3 Low Values...............................................................................234
7. 3. 4 Random Erroneous Results .....................................................234
7. 3. 5 Erroneous Values For All Samples With A Single Parameter..235
7. 3. 6 Anomalous Results With Two or More Parameters .................235
7.4 EQUIPMENT MALFUNCTION..................................................................236
7.5 MECHANICAL PROBLEMS......................................................................237
7.6 RESULTS FLAGS.....................................................................................238

7. 6. 1 Results outside the Specified Range .......................................238
7.7 ERROR FLAGS ........................................................................................239
7.8 5-MINUTE TROUBLESHOOTING GUIDE................................................242

7. 8. 1 Program Settings .....................................................................242
7. 8. 2 Calibration Information .............................................................243
7. 8. 3 Calibration Check Information..................................................244
7. 8. 4 Calibration Raw Data & Equation.............................................244
7. 8. 5 Calibration Time Course ..........................................................245
7. 8. 6 QC Information.........................................................................246
Page XIII
SECTION 8 ALARM CODES...........................................................................247
8.1 ALARM CLASSIFICATION AND ERROR CODES...................................248

8. 1. 1 Alarm Code Classification ........................................................248
8. 1. 2 Alarm Output ............................................................................248
8. 1. 3 Alarm Code Numbers...............................................................248
8.2 ALARM MESSAGES.................................................................................249

8. 2. 1 System Errors ..........................................................................249
8. 2. 2 Unit Errors ................................................................................252

8. 2. 2. 1 RPT Rotation...........................................................252
8. 2. 2. 2 RPT Vertical Movement (Origin RPT upper limit) ...253
8. 2. 2. 3 RPT (origin: upper limit of syringe)..........................255
8. 2. 2. 4 SPT Rotation...........................................................255
8. 2. 2. 5 SPT Up-and-Down Movement ................................256
8. 2. 2. 6 SPT Pump (origin: upper limit of syringe) ...............258
8. 2. 2. 7 Mix-1 Rotation .........................................................259
8. 2. 2. 8 Mix-1 Up-and-Down Movement ..............................259
8. 2. 2. 9 Mix-2 Rotation .........................................................260
8. 2. 2. 10 Mix-2 Up-and-Down Movement ..............................260
8. 2. 2. 11 WU Up-and-Down Movement .................................261
8. 2. 2. 12 WU Pump (origin: upper limit of syringe) ................261
8. 2. 2. 13 IRU ..........................................................................262
8. 2. 2. 14 RCU ........................................................................263
8. 2. 2. 15 FLT..........................................................................263
8. 2. 2. 16 ASP .........................................................................264
8. 2. 2. 17 ISE ..........................................................................264
8. 2. 2. 18 Tank (During prime operation) ................................265
8. 2. 2. 19 Tank (During running operation) .............................265
8. 2. 2. 20 Cover and Waste Liquid Chamber ..........................265
8. 2. 2. 21 IRU and RCU ..........................................................266
8. 2. 2. 22 Barcode Reader ......................................................266
Page XIV
SECTION 9 ISE USE AND MAINTENANCE...................................................267
9.1 GENERAL INFORMATION FOR ISE MEASUREMENT ..........................268

9. 1. 1 ISE Unit ....................................................................................268
9.2 ISE THEORY ............................................................................................269
9.3 ISE TECHNICAL SPECIFICATIONS ........................................................271
9.4 ISE OVERVIEW ........................................................................................272

9. 4. 1 ISE Module...............................................................................272
9. 4. 2 Description of ISE Reagents ....................................................273
9. 4. 3 Storage and use of ISE Reagents............................................275
9. 4. 4 ISE Unit Power Off ...................................................................275
9. 4. 5 ISE Module Storage .................................................................275
9. 4. 6 Loading Calibrator A ................................................................275
9. 4. 7 ISE Operating Cycles...............................................................276
9. 4. 7. 1 Serum Sample Cycle ..............................................276
9. 4. 7. 2 Urine Sample Cycle ................................................276
9. 4. 7. 3 Calibration Cycle .....................................................276
9. 4. 7. 4 Prime Cycle.............................................................276
9. 4. 7. 5 Electrode Exchange ................................................277
9. 4. 7. 6 ISE Cleaning Cycle .................................................277
9. 4. 7. 7 Stand-by cycle.........................................................277
9. 4. 8 ISE Parameters Screen ...........................................................277
9. 4. 9 ISE Parameters Screen -2 .......................................................278
9. 4. 10 Sample Processing ..................................................................279
9. 4. 11 ISE Calibration .........................................................................280
9. 4. 12 Replacing Calibrator A .............................................................282
9. 4. 13 Exchange Of ISE Electrodes....................................................283
9. 4. 14 Exchange Of ISE Pump Cassettes ..........................................286
9.5 ISE MAINTENANCE ................................................................................289

9. 5. 1 Maintenance Schedule.............................................................289
9. 5. 2 ISE Cleaning ............................................................................290
9.6 ERROR MESSAGES & ALARM CODES .................................................293
9.7 ISE TROUBLESHOOTING .......................................................................295

9. 7. 1 Analytical Problems..................................................................295
9. 7. 2 Equipment Problems................................................................299
Page XV
APPENDICES
APPENDIX A THEORY OF CALCULATIONS...............................................301
A.1 DATA PROCESSING AND CONVERSION..............................................302

A. 1. 1 Reaction Process and Measurement Points ............................302
A. 1. 2 Water Blank..............................................................................302
A. 1. 3 Absorbance Data .....................................................................302
A.2 MEASUREMENT PRINCIPLES................................................................304

A. 2. 1 End-Point Method (End)...........................................................304
A. 2. 2 Rate method.............................................................................304
A. 2. 3 Reagent Blank Correction ........................................................305
A.3 EXAMPLES OF ENDPOINT ASSAY METHODS .....................................307

A. 3. 1 End1: 1 Point ‘End’ Method......................................................307
A. 3. 2 End 2: 2 Point ‘End’ Method.....................................................308
A.4 EXAMPLES OF RATE BASED METHODS ..............................................310

A. 4. 1 Rate 1: 1 Point Rate-Method....................................................310
A. 4. 2 Rate 2: 2 Point Rate method....................................................310
A.5 MEASUREMENT RESULT CHECK .........................................................311

A. 5. 1 Linearity Check ........................................................................311
A. 5. 2 Absorbance Limit Check ..........................................................313
A. 5. 3 Absorbance of Limit Check Flags ............................................314
A. 5. 4 Prozone Check For Rate Assays .............................................315
A. 5. 5 Sens Check Formula................................................................317
A.6 CALIBRATION ..........................................................................................318

A. 6. 1 Measurement Principles of Calibration ....................................318
A. 6. 2 Calibration Check.....................................................................318
A. 6. 3 Duplicate Limit (Allowable Variation Limit) ...............................318
A. 6. 4 Sensitivity (Allowable Sensitivity Limit) ....................................319
A.7 CALIBRATION TYPE................................................................................320

A. 7. 1 Factor .......................................................................................320
A. 7. 2 Linear .......................................................................................320
A. 7. 3 Spline .......................................................................................322
A. 7. 4 Point to Point............................................................................322
A. 7. 5 Log-Logit ..................................................................................324
A. 7. 6 Exponential ..............................................................................324
APPENDIX B MAINTENANCE LOG.....................................................................327
Page XVI
APPENDIX C SOFTWARE UPGRADE PROCEDURE .......................................329
C.1 SOFTWARE UPGRADE (PCv130/Mainv136) ..........................................330

C. 1. 1 Preparation for Upgrade...........................................................330
C. 1. 2 Updating the Daytona Software backup on the PC..................331
C. 1. 3 Updating the Analyser PC software .........................................331
C. 1. 4 PC Localisation ........................................................................332
C. 1. 5 Updating the Analyser Main Software......................................332
C. 1. 6 Updating the Chemistry Parameters ........................................333
C. 1. 7 Summary..................................................................................333
APPENDIX D CHEMISTRY PARAMETER IMPORTING SOFTWARE ...............335
D.1 OVERVIEW...............................................................................................336
D. 1. 1 Software Versions ....................................................................336
D. 1. 2 Maximum Capacity...................................................................336
D. 1. 3 Limitation..................................................................................336
D. 1. 4 Installation ................................................................................337
D. 1. 5 Download Software (PC to Analyser).......................................337
D. 1. 6 Installation ................................................................................337
D.2 USER INTERFACE...................................................................................338

D. 2. 1 Update Parameters File to Latest Version ...............................338
D. 2. 2 Load New Methods into Analyser ............................................339
D. 2. 3 Update Existing Methods Stored in Analyser...........................340
D. 2. 4 Launch Analyser Software .......................................................341
D. 2. 5 Delete Unwanted Methods.......................................................341
APPENDIX E GLOSSARY ..................................................................................343
Page XVII
Page XVIII
SECTION 1 SAFETY PRECAUTIONS AND INSTALLATION Version 2.0 Rev September 2009
SECTION 1
SAFETY PRECAUTIONS AND INSTALLATION
rxsupport@randox.com Page 1
+44 (0) 28 9445 1070
1.1 WARNING SYMBOLS
WARNING
Biohazard
Electric Shock
High Temperature
Injury
Action to be taken as
directed in Operators
manual
+44 (0) 28 9445 1070
1.2 WARNING LABELS
WARNING LOCATION
Risk of electric Power supply inlet.

shock
Do not touch Covers of SPT,

moving parts RPT and MIX 1
Hot DTR
surface
Risk of electric Front Frame

shock
This tank con-

tains haz- Waste tanks
ardous
material
Contains
hazardous Mosaic 2, SWU
material serum, panel on right side
urine and plasma cover.
+44 (0) 28 9445 1070
WARNING LOCATION
Lid for replacing

halogen lamp, ISE
Risk of injury cover, panel for
replacing ISE
electrode
IRU head
Action to be insulation plate,
taken as detailed fans on rear frame
in operator (2 fans), right
manual frame, left frame.
The RX Daytona
analyser must be
disposed of in
Rear Panel of accordance with
Analyser the WEEE (Waste
Electronic and
Equipment
regulations).
+44 (0) 28 9445 1070
1.3 WARNINGS FOR SAFE USE
During operation, do not touch samples, reagents, nozzles or

any other moving mechanical parts of the analyser. Ensure that
the cover is kept closed at all times.
Ensure that gloves are worn when handling patient samples to

minimise infection. Gloves should be worn when handling the
SPT nozzle, RPT nozzle, reaction cells, wash nozzles and
waste nozzles.
Keep skin and mucous membranes free from contact with

reagents to protect operator from possible infection.
Follow the manufacturers instructions for reagents, control sera

and calibrators.
Gloves should be worn when handling waste solutions and

reaction cells to minimise the risk of infection. All waste
solutions should be disposed of according to the local pollution
and effluent discharge standards. The RX daytona produces
both high and low concentrated waste solutions.
Conductive parts within the analyser may cause serious electric

shock. Only qualified service personnel should carry out
maintenance and repair of internal electrical parts.
Reagent bottles should never be placed on the analyser as

careless handling may result in spillage or leakage of liquids into
the internal parts of the analyser.
Do not make any modifications to the analyser. Unauthorised

modifications to the analyser will invalidate your warranty
agreement.
Ensure that the analyser is switched off at the mains power

supply for at least 30 minutes prior to changing the halogen
lamp. This precaution is necessary to enable sufficient time for
the lamp to cool therefore reducing the risk of burns. Keep
hands away from the glass on the bulb and ensure there are no
cracks or breakages and that the gas has not leaked.
+44 (0) 28 9445 1070
1.4 SAFETY PRECAUTIONS

Carefully read this manual before using the analyser and become acquainted
with the recommended safety issues and procedures.
1. 4. 1 PREVENTION OF SYSTEM DAMAGE
1. Ensure system installation is carried out according to the recommendations pro-
vided with the RX Daytona Installation Guide.
2. Do not make any modifications to the analyser.
1. 4. 2 PREVENTION OF ELECTRIC SHOCKS

1. Do not remove any covers secured by screws as there is a risk of electric shock.
Covers secured with plastic clips may be removed. Contact Randox RX support if
the system requires attention.
2. In the event of a liquid spill inside the system, contact Randox RX support.
1. 4. 3 PREVENTION OF PERSONAL INJURY

1. Do not touch any moving mechanical parts such as the reagent or sampling
probes, while the system is in operation. During operation ensure that the cover
remains closed.
2. Observe the warning labels and symbols described in this manual.
3. Before changing the halogen lamp ensure that the system has been switched off
at the mains for at least 30 minutes to allow the lamp to cool therefore reducing
the risk of burn injuries. System calibration should be performed when a lamp is
changed. Keep hands away from the glass on the bulb and ensure there are no
cracks or damage.
1. 4. 4 SYSTEM ACCURACY AND PRECISION

1. Ensure the cover is closed while the system is in operation.
2. Perform system preparation checks before starting routine operation.
3. Follow the manufacturers instructions supplied with reagents, control sera and
calibrators.
4. Do NOT place reagent bottles or sample cups on the analyser.
+44 (0) 28 9445 1070
1. 4. 5 WASTE LIQUIDS
All waste solutions should be disposed of according to the local pollution and effluent
discharge standards. The RX daytona produces both high and low-concentration
waste liquid.
1. 4. 6 PREVENTION OF INFECTION
1. Gloves should be worn at all times when handling patient samples and waste
liquid, to protect from possible infection.
2. Gloves should always be worn when handling the SPT nozzle, RPT nozzle,
reaction cells, wash nozzles and waste nozzles.
1. 4. 7 REAGENT HANDLING
Ensure that hands and clothing do not come into contact with reagents as they may
contain strong acid or alkali.
1. 4. 8 GENERAL PRECAUTIONS
1. The system is designed to run serum, plasma, supernatants, urine, and CSF.
Please contact RX Support if you want to run any other sample types.
2. Ensure that samples are free from clots and debris to prevent blockage of the
reagent and sampling probes.
3. Ensure that the correct reagent volume is available to perform the necessary
number of tests.
4. Do not leave samples unsealed for extended periods as they may evaporate and
concentrate the sample.
5. Follow the instructions in this manual for loading samples, reagents and
calibration samples.
6. Ensure that calibration analysis is complete before routine operation.
7. Ensure that periodic system checks are performed and parts are replaced as
required.
8. If reagents or samples come into contact with the mucous membranes, flush with
copious amounts of water for at least 15 minutes. Ensure adequate flushing of
eyes by separating eyelids with fingers. If swallowed, wash out mouth with water
providing that the person is conscious. Contact a doctor as soon as possible. In
+44 (0) 28 9445 1070
case of skin contact immediately wash skin with soap and copious quantities of
water.
9. Never use the system for a purpose other than its intended use.
First aid measures in case of accidental contact:
Eyes: Irrigate thoroughly with water. If discomfort persists seek medical

attention.
Lungs: Remove from exposure.
Skin: Wash skin thoroughly with soap and water.
Mouth: Wash mouth thoroughly with water. Seek medical attention.
1. 4. 9 EMERGENCY SHUTDOWN PROCEDURE

During routine analysis, an emergency stop can be initiated by pressing CONTROL
and the F2 key simultaneously. The software will also interrupt routine operation when
there is a fault in the analyser.
PLEASE NOTE: Analysis data will be lost when an emergency stop is initiated.
The following procedures should be followed before resuming operation:
The cause of the emergency interruption must be resolved as follows:

1. In the case of user interruption due to settings of erroneous measuring conditions,
the correct settings are required.
2. In the case of an automatic system emergency interruption, open the cover of the
equipment and check that there are no items interfering with the mechanical
operation of the equipment. When the cause of emergency interruption is
unknown, contact RX Support to resolve the problem.
+44 (0) 28 9445 1070
1.5 INSTALLATION REQUIREMENTS

Please read this manual before using the analyser and become acquainted with
the recommended safety issues and procedures.
The RX daytona analyser must only be installed by a Randox authorised Service

Engineer. The recommended installation instructions detailed in the RX daytona
Installation Guide should be followed to ensure that system operation is unaffected by
external facilities and conditions.
1. 5. 1 RECOMMENDED INSTALLATION ENVIRONMENT

1. Avoid exposure to direct sunlight.
2. Ensure minimum exposure to dust and other airborne particles.
3. Site should be flat.
4. Minimum vibration.
5. Site should be of suitable construction to accommodate the weight of the
analyser.
6. Adequate uninterrupted power source.
7. Ensure adequate air circulation around the back of the analyser.
8. Site should be well ventilated.
9. Ensure adequate atmospheric pressure.
10. Do not install the analyser adjacent to a chemical storage room or any other
facility where gases are likely to be generated.
11. Do not install the analyser adjacent to a localized heat source such as a
refrigerator or freezer.
1. 5. 2 INSTALLATION PRECAUTIONS
1. Only qualified personnel should install and use the analyser.
2. The analyser weighs 135kgs and should be lifted by at least FOUR personnel. Lift
the analyser using the grips on the bottom four corners of the analyser.
3. Protect the analyser from liquid spillage or splashes.
4. Ensure the analyser is appropriately grounded.
5. Analyser use in the USA requires UL-certified accessories.
+44 (0) 28 9445 1070
6. Connect the analyser to the PC using the LAN cable provided. Other cables may
cause background noise or interference.
7. Ensure that all electrical cables are correctly connected.
8. Water quality of feed water into the analyser should conform to NCCLS Type II
specification or better.
1. 5. 3 TRANSPORT AND STORAGE CONDITIONS

1. Temperature during storage/transport must be between -10 to +50°C.
2. Humidity during storage/transport must be between 45-85% (no condensation).
3. Do not stack or place heavy objects on the transport container.
1. 5. 4 OPERATIONAL PRECAUTIONS
1. Observe the recommended installation environment and precautions as described
above.
2. Ensure that the ambient temperature of the laboratory is between 15 to 30°C to
ensure effective cooling of the reagents.
3. Ensure that electric cables are correctly connected.
4. Follow the daily maintenance procedure before operating the analyser. Ensure
that gloves are worn when handling sample nozzles, reagents and samples.
5. Ensure there are sufficient reagent volumes for routine operation.
6. Follow the recommended maintenance schedule to ensure efficient operation of
the system.
7. Shutdown the system completely when a serious malfunction is detected in the
analyser.
IMPORTANT
Warranty agreements will be invalidated if the following specifications are not adhered
to:
1. Environmental conditions must adhere to the specifications listed in this manual.
2. The analyser must only be operated by trained personnel.
3. The analyser must only be serviced or modified by Randox authorised engineers.
4. Replacement parts must be sourced from an authorised supplier.
+44 (0) 28 9445 1070
1.6 TECHNICAL SPECIFICATIONS
Analyser Description Clinical Chemistry Analyser

Recommended Use General chemistry as photometric assay
Immunology as photometric assay (Latex
reagent available)
Analysis Method 1 point end, 2 point end, 1 point rate, 2 point
rate
Calibration Options Factor, Linear, Log Logit, Exponential,
Spline, Point to Point.
Test Capacity 180 photometric tests per hour
270 ISE tests per hour
Maximum throughput 450 tests per hour.
Incubation Time One reagent assay 10 minutes
Two reagent assay 5 minutes for R1 +
5 minutes for R2
Sample Type Serum, Plasma, CSF, Urine, supernatants
Number of simultaneous 40 items (Max.) + Electrolyte (3 items)
measurements
Components
Main Analyser CHS (Chassis Unit)
IRU (Incubation Reaction Unit)
ASP (Auto Sampler Unit)
RCU (Reagent Container Unit)
RPT (Reagent Pipette Unit)
SPT (Sample Pipette Unit)
RPP (Reagent Pump Unit)
SPP (Sample Pump Unit)
WPP (Water Pump Unit)
DTR (Detector Unit)
MIX (Mixing Stirrer Unit)
WU (Wash Unit)
POW (Power Unit)
CNT (Control Unit)
Optional Accessories Personal Computer
LCD Display
Key-board
Mouse
Printer
+44 (0) 28 9445 1070
External Tanks Wash Solution No. 1

Wash Solution No. 2
Wash Solution No. 3
Optional Unit Electrolyte measurement unit (ISE unit)
Component Details
IRU (Incubation Reaction Unit) Heating method Direct heat with silicon
rubber heater
Heating range 37±0.3ºC
Cuvette Material PYREX
Size 8mm(W) x 6.23mm(D)
x30mm(H)
Path length 6mm
Quantity 45
Minimum volume 180µl
Maximum volume 500µl
ASP (Auto Sampler Unit) Normal Sample cups
Valid tube Diameter 13 ~ 16mm
Length 53 ~ 100mm
Paediatric sample cup and tube

Sample cup with lid 46mm x 10.8mm
Tube 85mm x 13mm
Turntable Removable type
Number of tubes Maximum 40
SPT/SPP (Sample Pipette Unit/ Number of pipette 1
Sample Pump Unit) Pump type Syringe pump
Liquid detection Detection of electrical
capacitance
Sampling volume 2 ~ 35µl (0.1µl/ step)
RCU (Reagent Container Unit) Turntable Removable type
Number of bottles Maximum 40
(20 bottles each for 100/
50ml and 20ml type)
Cooling method Cooling with 4 Peltier
elements
Cooling range 8ºC ~ 15ºC (when
ambient temperature is
between 15-30ºC)
Reagent inventory Monitors the dispensing
volume of reagent
+44 (0) 28 9445 1070
RPT/RPP (Reagent Pipette Unit/ Number of pipette 1

Reagent Pump Unit) Pump type Syringe pump
Liquid detection Detection of electric-
capacitance
Reagent volume 20 ~ 400µl (1µl / step)
DTR (Detector Unit) Absorbance measurements
(1 or 2 wavelength
measurement)
Selectable wavelength
(340, 415, 510, 546, 570,
600,660 and 700nm)
Light source Halogen lamp
Cooling for Air-cooled by fan
light source
MIX (Mixing Stirrer Unit) Stirring mechanism Stirring-bar rotated by
stepping motor
SWU (Supply Water Unit)
Liquid waste through nozzle 8 diaphragm pumps
Liquid waste at trough 1 diaphragm pump
Supply water at trough 5 diaphragm pumps
Supply detergent at trough 1 diaphragm pump
WPP (Wash Pump Unit) Detergent and water for cuvette cleaning
4 syringe pumps
WU (General Wash Unit)
Cleaning mechanism 8 cleaning steps
1st step Aspirate liquid and then add wash solution
2nd step Aspirate liquid and then add purified water
3rd step Aspirate liquid and then add wash solution
4th step Aspirate liquid and then add purified water
7th step Read water blank
8th step Aspirate liquid
9th step Dry
Power Unit Source AC 100~120V, 5.5A(Max.)/AC
200~240V, 2.8A(Max.), 50-60Hz.
+44 (0) 28 9445 1070
Environment (Operation) Temperature 15ºC ~ 30ºC

Humidity 45 ~ 85% (without
condensation)
Altitude Less than 2,000m
Definition of Installation Category in

IEC60664
Primary Circuit CATII
Secondary Circuit CATI
Pollution degree in IEC61010-1

Pollution Degree 2 (indoor use only)
Dimensions (main unit) 770mm(W), 620mm(D), 505mm(H)
Weight (Main unit) 135 Kg
Connectors on Main Analyser
Electrical Connectors Appliance inlet
RJ-45 modular jack (for connection between
Main Analyser and Operational PC)
D-sub receptacle
Piping Connectors System water
(for connection between Analyser High conc. waste
and External-Tanks) Low conc. waste
Wash solution 1
Wash solution 2
Wash solution 3
Maximum Sound level 60dB (When the cover is closed and the
operator is 1m or more from the analyser.)
Rating of Fuses
Type Size Rating Characteristics Location and Part no.

Glass tube 5x 20mm 1.6A / Time lag-Acting PCB: 25P3222 (ASP/
fuse 250V Slo-Blo RCU-DRV) F1
Glass tube 5x 20mm 3.15A / Time lag-Acting PCB: 25P3221 (SWU-
fuse 250V Slo-Blo DRV) F1
Glass tube 5x 20mm 5A /250V Time lag-Acting PCB: 25P3220 (PP-
fuse Slo-Blo DRV) F1
PCB: 25P3222 (ASP/
RCU-DRV) F2&3
Glass tube 5x 20mm 6.3A / Time lag-Acting Appliance inlet F1 & F2
fuse 250V Slo-Blo
Glass tube 5x 20mm 10A / Medium-Acting PCB: 25P3216 (IRU-
fuse 125V MITI DRV) F1
+44 (0) 28 9445 1070
1.7 SYSTEM CONFIGURATION AND EQUIPMENT LIST
PRINTER
WASTE
CONTAINERS
PC RX DAYTONA ANALYSER
SYSTEM WATER SUPPLY* WASH SOLUTIONS
*The RX daytona requires a supply of type II purified water. It must not be directly
connected to a pressurized water system. If a water system is used, the supply must
be connected to the supply tank reservoir.
+44 (0) 28 9445 1070
1.8 EQUIPMENT LIST

Box Equipment Model/Type/Spec. Q'ty Remarks
No.
1 Main Analyser 1
2 Accessories 1 Power cable for analyser 1
LAN cable 1
Halogen Lamp 1
Glass tube Fuse 6.3A/250V 2
Glass tube Fuse 5A/250V 3
Glass tube Fuse 10A/250V 1
Plastic Tube for Purified water 1
Plastic tube for High Conc. Waste 1
Plastic tube for Low Conc. Waste 1
Plastic tube for Wash Solution 1 1
Syringe tip insertion jig* 1
Syringe tip (TEF010) 1
Screwdriver #0 1
Hexagonal Wrench (6mm) 1
Hexagonal Wrench (0.9mm) 1
5L Plastic tank 1 1
5L Plastic tank 2 1
5L Plastic tank 3 1
10L Plastic tank 1
20L Plastic tank 2
+44 (0) 28 9445 1070
3 Accessories 2 Sample tray 1
ASP lid 1
Reagent Tray 1
RCU lid 1
4 Flat screen 1
5 Operational PC Personal computer 1

- PC/AT compatible,
- MS Windows NT 4.0 or XP
installed and can be operated
normally
Serial port:1 or more (RS232C)

Parallel port:1 or more
LAN port:1 or more (10baseT/
100baseTX)
6 Accessories 3 RX Wash Solution Number 1 (acid) 1 The components are only
supplied in quantities sufficient
RX Wash Solution Number 2 (alkali) 1 for system start up.
RX Wash Solution Number 3 1
(neutral) Extra supplies of the
components should be ordered
Probe adjustment tool 1 for routine analysis.
Pipette cleaning probe 1
Operators Manual 1
CD Software & Parameters Disc 1
D200-0018 1
ISE Wash solution 1
ISE Cal A 1
ISE Cal B 1
Urine Diluent 1
Electrode set 1
6 Printer Printer & parallel cable 1 Accommodates A4 size paper.
(Optional) In the EC, a CE-marked printer

has to be used.
Packaging
• Items 1 and, if provided 2, 3 and 4 in the equipment list are packed individually.
• Items 5, 6, and 7 are packed together.
+44 (0) 28 9445 1070
+44 (0) 28 9445 1070
SECTION 2 SYSTEM OVERVIEW Version 2.0 Rev September 2009
SECTION 2
SYSTEM OVERVIEW
+44 (0) 28 9445 1070
2.1 ANALYSER OVERVIEW

Figure 2.1 RX Daytona
Outer Lid
Analyser Status indicator lights
Orange - Power On indicator Green - Analyser ready
Figure 2.2 RX Daytona with outer lid open and unit lids in place
Reagent Pipette Unit (RPT) Sample Pipette Unit (SPT)
Incubation
Reaction
Unit (IRU)
Reagent Container Unit (RCU) Auto sampler Unit (ASP)
+44 (0) 28 9445 1070
Figure 2.3 RX Daytona with outer lid open and unit lids off
Reagent Pipette Unit (RPT) Wash and MIX-2 Units
MIX-1 Unit Incubation

Sample Pipette
Reaction
Unit (IRU) Unit (SPT)
Reagent Container Unit (RCU) Auto sampler Unit (ASP)
The RX daytona is used for the determination of clinical chemistry parameters in

serum, plasma, supernatants, urine, and CSF samples. The process is completely
automated using mechanical components for sample and reagent dispense, mixing
and measurement.
2. 1. 1 REAGENT MANAGEMENT (RCU SCAN)

On-board reagent information is recorded by scanning the reagent barcode labels
attached to the bottles. This is performed during one turn of the reagent tray in the
RCU unit. This process should be performed prior to pressing the START F1 key.
The following operations are performed after pressing START F1.
+44 (0) 28 9445 1070
2. 1. 2 PREPARATION
2. 1. 2. 1 INITIALISATION OF HARDWARE.
Each unit returns to its home position.
2. 1. 2. 2 LAMP GAIN OPTIMISATION.

Automatic lamp gain optimisation is performed.
2. 1. 2. 3 PRIME
Nozzles are situated at their respective troughs. Each pump and syringe operates
and sends solution to each line to remove air.
2. 1. 2. 4 SAMPLE BARCODE LABEL SCAN (BARCODE MODE ENABLED)

An enquiry is made to the host computer about the set of tests required for each
sample.
2. 1. 3 FIRST REAGENT MEASUREMENT

The following processes describe the sequence of events for routine analysis,
assuming that all reagent, and system checks have been carried out.
2. 1. 3. 1 FIRST REAGENT DISPENSE

The reagent container unit (RCU) and the reaction table (IRU) rotate to the position
where the reagent is aspirated and dispensed by the reagent pipette unit (RPT) into a
cuvette on the IRU.
2. 1. 3. 2 SAMPLE DISPENSE
Sample is then aspirated and dispensed from the auto sampler unit (ASP) into the
cuvette on the reaction table (IRU) containing the pre-dispensed primary reagent. The
IRU rotates to the position where the sample pipette unit (SPT) dispenses the sample.
2. 1. 3. 3 MIXING
The IRU then rotates to the mixing position (MIX-1).
+44 (0) 28 9445 1070
2. 1. 3. 4 MEASUREMENT OF ABSORBANCE (1 - 13)

The IRU rotates to the absorbance measurement position. Thirteen absorbance
measurements of the cuvette are taken every 20 seconds and the time course data of
the first reagent is stored.
2. 1. 4 SECOND REAGENT MEASUREMENT

2. 1. 4. 1 SECOND REAGENT DISPENSE
The reagent container unit (RCU) and the reaction table (IRU) rotate to the position
where the second reagent is aspirated and dispensed by the reagent pipette unit
(RPT) into the cuvette on the IRU which contains the primary reagent and sample
mixture.
2. 1. 4. 2 MIXING
The IRU then rotates to the mixing position (MIX-2).
2. 1. 4. 3 MEASUREMENT OF ABSORBANCE (14 - 26)

The IRU rotates to the absorbance measurement position. Thirteen absorbance
measurements of the cuvette are taken every 20 seconds and the time course data of
the second reagent is stored.
2. 1. 5 WASH
After completion the cuvette moves to the wash unit (WU). The reaction solution is
drained from the cuvette and the cuvette is washed thoroughly.
2. 1. 6 EMERGENCY STOP
During routine analysis, an emergency interruption is possible by pressing the
CONTROL and F2 keys simultaneously. The software will also interrupt routine
operation when there is a fault in the analyser.
PLEASE NOTE: Analysis data will be lost when an emergency stop is initiated.
The following procedures should be followed before resuming operation:
1. In the case of user emergency stop due to the settings of erroneous measuring
conditions, the correct settings are required.
+44 (0) 28 9445 1070
2. In the case of an automatic system emergency stop, lift the lid and check that
there are no items interfering with the mechanical operation of the equipment.
3. If the cause of emergency stop is unknown, contact RX Support.
2. 1. 7 AUTOMATIC RERUN
When a sample concentration is greater or lower than the technical range of the
equipment and automatic reruns are enabled the sample is re-run (please see
Section 4.2“SAMPLE RE-RUNS” on page 120 for a more detailed description of
automatic re-runs). Rerun volumes are based on pre-defined system settings for
sample volume, diluent volume and diluted sample volume for analysis. Sample
dilution may be carried out using a defined diluent according to the defined settings in
the Chemistry Parameters screen. The analytical result reported for the diluted
sample is already corrected for the dilution.
2. 1. 8 REAGENT BLANK MEASUREMENT

The absorbance is measured of a cuvette without sample. Sample results may then
be corrected with the reagent blank value.
2. 1. 9 WATER BLANK MEASUREMENT (CUVETTE CHECK)

The absorbance is measured of a cuvette containing water. The result is used as a
guide for assessing the degree of staining on the cuvette.
The analyser will perform a cuvette check at the beginning of each run by washing the
cuvettes and then checking the absorbance measurement.
2. 1. 10 ISE MEASUREMENT
This measurement is carried out when the optional ISE unit is present in the analyser
and an ISE test is requested. ISE analysis of urine samples requires a 1 in 10 dilution
(this is performed automatically) and a dedicated urine diluent must be used. This
diluent needs to be placed in the RCU tray and registered in the SYSTEM/
PARAMETERS menu. ISE priming, cleaning and calibration are performed via the
MAINTENANCE/ SEQUENCE (F9) screen.
+44 (0) 28 9445 1070
2.2 SYSTEM COMPONENTS

This section gives a detailed description of each of the system components. Refer to
section 2.1“ANALYSER OVERVIEW” on page 20 for the location of individual system
components.
2. 2. 1 AUTOSAMPLER UNIT (ASP)

The Auto Sampler Unit (ASP) consists of a removable turntable, sample tube rack
and sample barcode reader.
Figure 2.4 Autosampler Unit (ASP)
Aperture for barcode
Removable Turntable
Sample Tube Holder
The ASP accommodates 40 sample tubes. Each sample is aspirated by the sample
pipette unit (SPT) and dispensed into a cuvette in the incubation reaction unit (IRU).
The sample pipette unit can dispense serum, plasma, supernatants, urine, and CSF.
The sample turntable rotates counter clockwise.
+44 (0) 28 9445 1070
2. 2. 1. 1 TURNTABLE
The sample tube with barcode label attached is inserted into the tube holding
mechanism. A total of 40 sample tubes can be accommodated (20 inner ring and 20
outer ring).
2. 2. 1. 2 BARCODE READER
Barcodes are read on labels attached to the outer surface of the sample tube. Tubes
should be positioned with the barcode label facing outwards so that they can be
scanned by the barcode reader. The types of usable sample tubes are shown below:
Diameter: 13 mm – 16 mm
Length: 53 mm – 100 mm
Extent of label fitting: Refer to drawing below.
5mm
47mm
Printable Barcode Area
abc
5mm
12.5- 14.5 mm
Valid barcodes for the RX daytona analyser:
Symbol Valid Character symbol
NW-7 digits (0-9), symbols (!, #, $, (,), +, -, ., /, :, ;, <, =, >, ?, @,

[,], {,}, ~.
Code 39 digits (0-9), alphabetical letters, symbols (-, space, $, /,
+, %.
ITF digits (0-9).
UPC digits (0-9).
Code 128 All ASCI code characteristics digits (0-9), alphabetical
Set A, Set B, Set C letters, (upper and lower case), symbols, control
characters.
+44 (0) 28 9445 1070
Allowable characters for sample number and patient ID:

Numerical characters 0 to 9
Alphabetical characters A to Z and a to z
Symbols !, ‘’, #, $, (, ), +, -, ., /, :, ;, <, =, >, ?, @, [, ],{, }, ~
2. 2. 2 REAGENT CONTAINER UNIT (RCU)

The Reagent Container Unit (RCU) consists of reagent bottle rack, bar code reader,
cooler and sensor.
Figure 2.5 Reagent Container Unit
RCU barcode
reader
window
located
here
Reagent
Bottle
Rack
Handle
2. 2. 2. 1 REAGENT BOTTLES
The reagent container unit can use three sizes of bottle (see Figure 2.6“ Reagent
Bottle Types” on page 28).
+44 (0) 28 9445 1070
Figure 2.6 Reagent Bottle Types

100ml bottle
50ml bottle
20ml Bottle
2. 2. 2. 2 REAGENT TRAY
The RCU reagent tray accommodates a maximum of 40 reagent bottles. The reagent
tray rotates and the required reagent bottle is moved to the reagent aspirating
position.
Figure 2.7 Reagent Carousel
Inner ring for 50ml

& 100ml bottles
Outer ring for

20ml bottles
+44 (0) 28 9445 1070
2. 2. 2. 3 COOLER
When the analyser is switched on (including during sleep mode) the temperature in
the RCU is controlled by the cooling power unit (CPU). A temperature sensor in the
RCU ensures that the reagent temperature is maintained between 8 -15ºC provided
that the ambient temperature is between 15-30ºC.
2. 2. 3 SAMPLE PIPETTE UNIT (SPT)

The Sample Pipette Unit (SPT) consists of a vertical movement mechanism, level
sensor and lower limit sensor. The sampling is performed by a pipette connected to
the sample aspiration syringe via a resin tube.
When an ISE unit is fitted and ISE measurement is performed, the SPT aspirates
sample for ISE measurement and dispenses it into the sample port of the ISE unit.
Figure 2.8 Sample Pipette Unit (SPU)
SPT trough
SPT nozzle
2. 2. 3. 1 LEVEL SENSOR
When the tip of the nozzle touches the sample surface, the electrostatic capacitance
of the metallic nozzle varies. This variation is used to determine the level of liquid in
the sample tube.
WARNING: Level sensors are not utilised with paediatric sample cups. The
pipette head descends to a pre-defined height, based on the dimensions of the
recommended sample cups and tubes. It is important that only recommended
sample cups and tubes are used for analysis of small sample volumes.
+44 (0) 28 9445 1070
2. 2. 3. 2 LOWER LIMIT SENSOR

The lower level detector will detect when the tip of the nozzle hits the bottom of the
sample cup due to insufficient sample volume. Downward pipette movement is then
prevented.
2. 2. 3. 3 SPT TROUGH
After sampling is completed, the tip of the SPT nozzle is washed with system water in
the SPT trough.
2. 2. 4 REAGENT PIPETTE UNIT (RPT)

The Reagent Pipette Unit (RPT) consists of vertical movement mechanism, level
sensor and lower limit sensor. The RPT aspirates primary or secondary reagent and
dispenses it into a reaction cell in the IRU.
Figure 2.9 Reagent Pipette Unit
RPT trough
RPT nozzle
+44 (0) 28 9445 1070
2. 2. 4. 1 LEVEL SENSOR
When the tip of the nozzle touches the reagent surface, the electrostatic capacitance
of the metallic nozzle varies. This variation is used to determine the level of liquid in
the reagent bottle.
2. 2. 4. 2 LOWER LIMIT SENSOR

The lower level detector will detect when the tip of the nozzle hits the bottom of the
reagent cup due to insufficient reagent volume. Downward pipette movement is then
prevented.
2. 2. 4. 3 RPT TROUGH
After dispensing is completed, the tip of the RPT nozzle is washed in the RPT trough.
2. 2. 5 INCUBATION REACTION UNIT (IRU)

The Incubation Reaction Unit has 45 pyrex reaction cuvettes on the outer
circumference, which are kept at a constant temperature of 37ºC by heating
elements. Sample dilution (where applicable), dispensing, stirring, and measurement
of sample and reagent mixtures are performed in the IRU and the cells are rotated at
20 sec intervals. The pyrex cuvettes are washed automatically after each use.
+44 (0) 28 9445 1070
Figure 2.10 Incubation Reaction Unit
Reaction Cuvettes
RPT nozzle
Incubation heating
elements
Photometer
2. 2. 5. 1 CUVETTE HOLDER
The Cuvette Holder has slots to accommodate the 45 reaction cells on the outer
circumference.
2. 2. 5. 2 TEMPERATURE SENSOR AND HEATER

Three sensors on the cuvette holder ensure that the IRU is thermostatically
maintained at 37ºC.
2. 2. 6 DETECTOR UNIT (DTR)

The Detector Unit (DTR) consists of the optical measurement system and filter
rotating mechanism.
The absorbance inside the cuvette of the IRU unit is measured using a photometer.
Measurement is performed with any 1 or 2 wavelengths selected from the following 8
wavelengths: 340, 415, 510, 546, 570, 600, 660 and 700 nm.
2. 2. 6. 1 PHOTOMETER
The photometer consists of a halogen lamp, lens, optical filter and photoreceptor
(photodiode). The lens comprises of a condenser and a focusing lens. The condenser
+44 (0) 28 9445 1070
lens converts the light from the halogen lamp into a collimated light beam that is then
focused through the focusing lens in the direction of the photoreceptor.
The photoreceptor converts the light passing through the solution in the reaction cell
into an electrical signal.
2. 2. 7 STIRRING UNIT (MIX-1 & MIX-2)

The analyser has two stirring units MIX-1 and MIX-2. (See location of MIX units on
Figure 2.3“RX Daytona with outer lid open and unit lids off” on page 21).
2. 2. 7. 1 MIX-1
After sample and first reagent dispense into the reaction cell the liquid is stirred by a
paddle attached to the tip of the nozzle on the MIX-1 unit. The tip of the stirrer nozzle
is then washed in the MIX-1 trough.
2. 2. 7. 2 MIX-2
After dispense of the second reagent into the reaction cell the liquid is stirred by a
paddle attached to the tip of the nozzle on the MIX-2 unit. The tip of the stirrer nozzle
is then washed in the MIX-2 trough.
2. 2. 8 WASH UNIT (WU)

After completion of the assay steps and absorbance measurement, the wash unit
(WU) washes the reaction cell to prepare for re-use.
Figure 2.11 Wash Unit Diagram
Pour
nozzle
Wipe
Drain chip
nozzle
+44 (0) 28 9445 1070
Figure 2.12 Wash Unit
MIX-2 Unit
Six sets of nozzles

each with two nozzle
heads, drain (long)
and pour (short) nozzle
Wipe chip
The wash unit consists of 6 dispense nozzles and 7 drain nozzles (including the final
drain nozzle), and a wipe chip which removes residual water droplets. The nozzles
move over the reaction cuvettes and are then lowered into the cuvette by the vertical
movement mechanism.
The solution inside the reaction cuvette is drained and pure water or wash solution is
dispensed into the cell. This is then aspirated from the cuvette and the process
repeated according to pre-set wash directions.
The drain nozzle is connected to the supply water unit (SWU) drain pump via a resin
tube.
The dispense nozzle is connected to the WPP syringe via a resin tube.
+44 (0) 28 9445 1070
2. 2. 9 PUMP UNIT
The pump unit (PP) consists of 8 pumps, syringes and solenoid valves.
Figure 2.13 Wash Pump Supply System
WU-5,6 Water Supply Syringe WU-2,4 Water Supply Syringe
WU-3, Water Supply Syringe

WU-1, Water Supply Syringe
Solenoid Valve (SPP-EV)

Solenoid Valve (RPP-EV)
SPP Sample Syringe RPP Reagent Syringe
RPP WaterSupply Syringe

PP Water Supply Syringe
2. 2. 9. 1 PUMPS
The SWU unit is located on the right-hand side of the analyser and consists of various
diaphragm pumps for water supply and draining of the wash unit (WU).
Description Number Type

Pumps for WU-1 to WU-7 7 NF10
Pump for WU-8 1 NF30
Pump for pure water supply into RPT trough 1 NF10
Pump for detergent solution supply into RPT
1 NF10
trough
2 (side of trough
Pumps for pure water supply into SPT trough and bottom NF10
supply)
Pump for pure water supply into MIX-1 trough 1 NF10
Pump for pure water supply into MIX-2 trough 1 NF10
Pump for drain of RPT/SPT/MIX-1/MIX-2
1 NF30
troughs
+44 (0) 28 9445 1070
2. 2. 9. 2 SYRINGES
There are four supply syringes within the pump unit that supply water to the six
dispense nozzles on the wash unit. All four wash unit syringes are linked in their
operation. Four additional syringes on the pump unit which include the SPP sample
syringe, SPP system water supply syringe, RPP reagent syringe and the RPP pure
water supply syringe.
Wash Unit Syringe Description

WU-1 water supply syringe This syringe aspirates purified water from the water
tank and dispenses via WU-1 nozzle into the
cuvette.
WU-2, 4 water supply This syringe aspirates purified water from the water
syringe tank and dispenses via WU-2 and 4 nozzles into the
cuvette.
WU-3 water supply syringe This syringe aspirates purified water from the water
tank and dispenses via WU-3 nozzle into the
cuvette.
WU-5, 6 water supply This syringe aspirates purified water from the water
syringe tank and dispenses via WU-5 and 6 nozzles into the
cuvette.
SPP sample syringe This syringe aspirates sample via the SPT nozzle
and dispenses it into the cuvette on the cuvette
holder. (Operation is linked with the SPP purified
water supply syringe).
SPP system water supply This syringe aspirates purified water from the
syringe system water tank to draw water into the SPP line.
During sample dispense, the sample at the tip of the
SPP nozzle is pushed out by the water. (Operation
is linked with the SPP sample syringe).
RPP reagent syringe This syringe aspirates reagent via RPT nozzle and
dispenses it into cuvettes on the cuvette holder.
(Operation is linked with the RPP pure water supply
syringe).
RPP pure water supply This syringe aspirates purified water from the
syringe system water tank to draw water into the RPT line.
During reagent dispense, the reagent at the tip of
the RPP nozzle is pushed out by the water.
(Operation is linked with the RPP sample syringe.)
+44 (0) 28 9445 1070
2. 2. 9. 3 SOLENOID VALVE
A solenoid valve enables the syringe to switch between aspiration and drain.
SPP-EV Switches between aspiration to and dispense from the SPP line.
RPP-EV Switches between aspiration to and dispense from the RPP line.
2. 2. 10 ELECTROLYTE MEASUREMENT UNIT (ISE OPTION)

The concentration of the electrolytes: sodium, potassium and chloride contained in
blood serum, plasma or urine are measured by the Ion Selective Electrode (ISE) unit,
which is located on the right-hand side of the analyser (This unit is optional).
Figure 2.14 Location of ISE Unit
Access door to
change Cal A bag
for ISE unit
Access door for

ISE unit
Figure 2.15 ISE Unit with door open
ELECTRODES
Sodium
Potassium
Chloride
Reference
+44 (0) 28 9445 1070
Figure 2.16 Location of Calibrant A for ISE unit
ISE unit
Calibrant A Bag
The ISE unit consists of ion selective electrodes, supply and drain pump, a pre
amplifier board and I/O board.
Ion selective This consists of Na+, K+, Cl- and reference electrodes.
electrode The thermo-regulator heater is located at the rear of the
ISE unit where the electrode connections are situated.
Calibration A solution is installed in a special
compartment as shown above.
Calibration B solution (or wash solution) is placed in the
ASP unit at position 18.
Supply and drain The motor and position sensor control the pump. It is
pump used to supply and drain calibration solution, sample,
diluent solution and wash solution.
Pre amplifier board To convert the analogue signals from electrode and
temperature sensor to digital signal.
The following solutions are supplied for the ISE unit:
Calibrant A Calibrant A is used for calibration and for flushing the

electrode every time sample measurement is performed.
120µl of calibrator A is automatically dispensed into the ISE
unit every 30 minutes to prevent the electrode from drying out.
The Cal A bag is located beside the ISE unit. 320μl of
calibrator A is aspirated during ISE calibration. The Cal A bag
can be assessed for replacement by removing the ISE cover.
+44 (0) 28 9445 1070
Calibrant B This is used for calibration of the ISE unit.

500μl of calibrator B is placed in a sample cup at position18 in
the ASP tray. 200µl calibrator B is aspirated during ISE
calibration. Calibration is carried out at the beginning of each
day and at least every 8 hours.
Calibrant B is dispensed using the following menu options:
1. Select MAINTENANCE menu option from the job menu
2. Select SEQUENCE (F9)
ISE Cleaning • ISE cleaning solution is dispensed into the unit to avoid a
Solution
build up of protein on the electrode. When necessary,
600µl of cleaning solution is placed in a sample cup at
position 18 in the ASP tray. ISE cleaning is recommended
at the end of the day via automatic sleep function and at
least every 8 hours if greater than 50 samples are
processed per day. Cleaning solution is dispensed using
the following menu options.
Refer to section 9. 5. 2“ISE Cleaning” on page 290.
• Select MAINTENANCE menu option from the job menu
• Select SEQUENCE (F9)
• Press START in the ISE cleaning field.
Diluent Urine diluent is used to dilute urine samples 1 :10.

Diluent is presented in a reagent bottle, which is placed on the
RCU unit. Approximately 315µl of diluent is required for the
dilution of each sample. The dilution is carried out using a
cuvette on the IRU unit and one cycle of chemistry analysis is
allocated to the dilution.
The diluent is pre-registered with a reagent code under the
SYSTEM PARAMETERS section of the job menu under
SYSTEM (F9).
Sampling 100µl sample is aspirated for each ISE measurement.
Volume
+44 (0) 28 9445 1070
2.3 SOFTWARE OVERVIEW

This section provides an overview of the software which includes the location and
function of keys and the menu layout.
2. 3. 1 KEYBOARD LAYOUT
To perform screen operations it is important to become familiar with the keyboard
layout, functions of each key, menu structure and methods of data entry.
The equipment may be operated using the keyboard of a PC or a mouse. The

functions of each key (except character and numerical keys) are shown below. The
‘Key ID’ numbers listed below are used throughout the manual.
Key Key ID Function Description
F1 [F1] Start To start or resume measurement.
To stop further sampling.

F2 [F2] Stop Processing will continue for
samples that have already been
dispensed into the IRU.
F3 [F3] Emergency Displays on-screen menu for

(STAT/NORM) addition of an emergency or normal
sample.
F4 [F4] Alarm Displays the alarm log.
F5 [F5] Run Monitor Display of routine operation

progress.
+44 (0) 28 9445 1070
F6 [F6] Chemistry Displays analytical conditions.

Parameter
F7 [F7] Calibration Displays calibration details.
F8 [F8] QC Displays quality control details.
[F9]
F9 Screen selection Determined by the menu option
[F10] selected.
F10
F11
[F11]
F12
[F12]
[Contrl]
Ctrl F5 + Print screen Print on-screen display to printer.

[F5]
[Scroll
Scroll Lock] Print stop Interrupt printing.
Lock
Move the pointer for on-screen

Tab [TAB] Tab selection.
The pointer may be moved in the
reverse direction by pressing [Shift]
+ [Tab] keys.
Enter [Enter] Registration Register the entered data.
Change between upper and

Shift [Shift] Shift lowercase characters. Move the
pointer in the reverse direction by
pressing [Shift] + [Tab] keys.
+44 (0) 28 9445 1070
[B-Space] Character Delete characters in the enter field.

Back deletion
Space
Termination of assay by pressing
Ctrl
[Ctrl] + Emergency Stop [Control] + [F2] keys.
F2
[F2]
Move the cursor to the top of the

Home [Home] Home items in the scroll or list box.
Move the cursor to the end of the

End
[End] End items in the scroll or list box.
Page
[PgUp] Page up Move up through the pages on the
Up
menu.
Page [PgDn] Page down Move down through the pages on

Down
the menu.
[Space] Space Selection menu
Select an item among selectable

Cursor (fixed) items, e.g. qualitative or
quantitative selection of analytical
conditions.
Esc [ESC] Escape Close window.
+44 (0) 28 9445 1070
2. 3. 2 MENU STRUCTURE
Run Monitor [F5] Run Monitor [F9] Run monitor display
Test Selection [F10] Page-1/2 : Test selection

Page-2/2 : Emergency test (when barcode enabled)
Inventory [F11] Page-1/2 : General information

Page-2/2 : Detailed information
Automatic Rerun selection

Automatic Print-out selection
Condition [F12] Serum Information selection
Host Communication Mode selection
Prime Mode selection
Chemistry Prm [F6] Chemistry [F9] Page-1/2 : Chemistry Parameters for each Method
Page-2/2 : Serum Indices
Calculate [F10] Calculated test expression
Profile [F11] Profile definition
Order [F12] Page-1/2 : Testing order definition

Page-2/2 : Print out order definition
Calibration [F7] Calibration [F9] Page-1/2 : Calibration setting

Page-2/2 : Serial Dilution
Limit Checks (Duplicate, Sensitivity, Linearity, Prozone, Absorbance)

Checks [F10] Replicate Standard (Duplicate, Triplicate)
Measurement of Reagent Blank at Full Calibration
Measurement of Reagent Blank during Run
Multi [F11] Multi Standard definition
QC [F8] Graphics [F9] Page-1/2 : QC chart-1,2 (Levey-Jennings Chart)

Page-2/2 : QC chart-3 (Levey-Jennings Chart)
Measurements [F10] QC Results list
QC Setting [F11] Definition of parameters for QC chart
Control [F12] Registration of Control Sample
System Parameters Page-1/2 : Communication param. , Sample BCR param. ,

System [F9] Print-header input, Reagent code registration.
Page-2/2 : Patient information definition, Number of replicate setting
Save to FD of mechanical parameters

FD [F10] Save to FD of user parameters
Load parameters (former generation) from FD, Format FD
ISE [F11] Reagent code of ISE diluent, ISE calibration result

Instrument factor for ISE
Result [F12] Measured results
Initialisation, Prime, Cuvette check, Cuvette wash, etc

Maintenance Sequence [F9] ISE prime, ISE cleaning, ISE calibration
Sensor testing
Page-1/2 : SPT/RPT wash, Wash program definition

Wash [F10] Working hour counter
Page-2/2 : Cuvette water blank check
Performance [F11] Temperature.monitor of IRU & RCU

Detector performance monitor
Auto Start [F12] Auto start scheduling, Prep1/Prep2 setting

Auto prime parameter (Short prime/Full prime interval set)
+44 (0) 28 9445 1070
2.4 SCREEN LAYOUT

The screen layout is shown in figure 2.17 below. JOB MENU items are displayed on
screen and may be selected by clicking directly on screen or using the function keys
F5 to F8. SYSTEM PARAMETER and MAINTENANCE options cannot be selected
using function keys.
Figure 2.17 On-Screen Display
JOB MENU Equipment Status STAT information Shutdown button
GLOBAL MENU FUNCTION KEYS
2. 4. 1 JOB MENU
The Job Menu groups together related commands under common headings such as
Maintenance, Chemistry Parameters and Calibration.
2. 4. 2 GLOBAL MENU
The Global Menu includes operations such as Emergency Stop and Alarm Screen
Access. These options are displayed on all Job Menu screens in the software.
+44 (0) 28 9445 1070
2. 4. 3 FUNCTION KEYS
The Function keys are used to select a function within a selected Job Menu screen.
Functions keys are displayed on screen and are specific to each Job Menu option.
2. 4. 4 EQUIPMENT STATUS
Details the operational status information displayed on screen.
Status Information
Analyser initialisation in progress.
Analyser initialisation completed.
Analyser initialisation interrupted.
Prime sequence in progress.
Prime sequence completed.
Measurement in progress.
Sampling restart in progress.
Sampling restart ready.
Sampling stop in progress.
Sampling stop ready.
Measurement completed.
Emergency stop.
Analyser restart in progress.
Analyser restart completed.
Analyser restart interrupted.
Emergency stop in progress.
Emergency stop completed.
Sensor reading in progress.
Sensor reading completed.
+44 (0) 28 9445 1070
2. 4. 5 MENU DESCRIPTION
Description of information required in the selected field.
2. 4. 6 PAGE NUMBER
Page number displayed.
2. 4. 7 STAT INFORMATION
When an emergency sample is being processed the message “STAT” is displayed
with a red background.
2. 4. 8 SHUTDOWN BUTTON
Selecting the Shutdown button will result in an on-screen dialog box appearing
offering the options to ‘POWER OFF’, ‘SLEEP’ or ‘CANCEL’. Use the ‘POWER OFF’
option to shut down the analyser and restart PC.
+44 (0) 28 9445 1070
SECTION 3 SYSTEM PREPARATION AND ROUTINE ANALYSIS Version 2.0 Rev September 2009
SECTION 3
SYSTEM PREPARATION AND ROUTINE ANALYSIS
+44 (0) 28 9445 1070
3.1 PREPARATION FOR ANALYSIS

The following checks MUST be carried out prior to commencing analysis.
3. 1. 1 INITIALISATION OF HARDWARE
The analyser can be switched on using one of the following options:
• If SLEEP MODE was selected at shutdown, the unit is automatically activated

according to the conditions specified on the MAINTENANCE / AUTOSTART F12
screen. SLEEP MODE can be cancelled by clicking on the CANCEL button. This
will re-initialise the analyser and make it ready for use.
• If POWER OFF MODE was selected at shutdown, restart as follows:-
1. Start up the Analyser

The power switch is located on the left side panel of the main unit.
Figure 3.1 Location of Power Switch (left side panel)
Power supply point Power switch LAN connection
2. Turn on the PC
Turn on the PC (Refer to the Operator Manual supplied with the PC)
The software for the main unit starts up automatically when the PC is switched on.
+44 (0) 28 9445 1070
3. 1. 1. 1 MAINTENANCE SUMMARY
The table below lists the maintenance required before each run and on a daily and
weekly basis. Please see Section 6“MAINTENANCE” on page 191 for more details.
Interval Check point

Before • Fill system water tank with water (at least NCCLS type II water).
analysis • Check the remaining volumes of wash solutions in tanks and
refill if necessary.
• Check cuvette water blanks in MAINTENANCE/WASH (F10)
(Page 2/2).
• Empty waste tanks and ensure there is sufficient printer paper.
Daily • Wipe any stains on the internal surface (inside outer lid) using a
clean damp cloth.
• Use an absorbent cloth to remove any condensation in the RCU
tray
• Clean the outside of the sample and reagent probes with a
swab soaked with alcohol.
• If ISE unit is present, check the remaining volume of calibrator A
and ensure tip of calibrator A tube is at the bottom of the bag.
• At the end of analysis perform ISE cleaning if appropriate.
Weekly WARNING: Analyser must be switched off for weekly cleaning

to allow for easy and safe movement of mechanical parts.
• Clean the ASP unit.

• Clean the reagent container unit (RCU).
• Clean pipette cover, trough and mosaic plates thoroughly.
• Remove wash unit cover and clean wash probes with a swab
soaked with alcohol.
• Carefully raise mixers and clean with a swab soaked with
alcohol taking care not to bend or break the mixers
• Use C1 solution as prompted when entering ‘SLEEP’ mode to
clean SPT probe.
As required • Use probe cleaning tool to clean the inside of the sample probe
and reagent probe.
+44 (0) 28 9445 1070
Figure 3.2 External Tanks
PLEASE NOTE: External Wash tanks should be cleaned everytime new

solutions are prepared and it must be ensured that the system water tank is
kept clean.
Figure 3.3 Tube Connection of SWU Panel (Right side of the analyser)
+44 (0) 28 9445 1070
3. 1. 2 SYSTEM INITIALISATION AND PRIME

Initialisation is automatically performed after the analyser and the PC are switched
on. If an optional ISE unit is present, 5 ISE primes each lasting approximately one
minute will be performed.
WARNING: Ensure all electrodes are installed in the ISE unit otherwise
Calibrator A may flood the interior of the analyser causing system malfunction.
3. 1. 2. 1 AUTOMATIC INITIALISATION
After switching on the analyser system initialisation is performed automatically and
takes around 1 minute. The analyser moves all onboard items to the home/starting
position e.g. pipettes, cuvettes, reagent wheel and sample wheel. The system will
remain in stand-by mode for 30 minutes after power ON to ensure the lamp reaches
optimal intensity and stability. It is not possible to start any measurements during this
time.
3. 1. 2. 2 MANUAL INITIALISATION
Manual initialisation may be required if the operator has manually moved the probes
(i.e during cleaning).
Manually initialise the analyser as follows:

1. Select MAINTENANCE/SEQUENCE [F9].
2. Select START for Initialisation.
The following message will appear:
‘Starting system initialisation’
3. Select OK
The analyser will automatically initialise.
3. 1. 2. 3 SYSTEM PRIME
Priming of the water lines within the analyser is necessary to remove trapped air
within the system ensuring optimum analytical performance. Before measurement the
operator must specify the prime mode on the software.
To select PRIME follow the instructions below.
+44 (0) 28 9445 1070
1. Select RUN MONITOR/CONDITION [F12].

2. Select the Prime Mode (see figure 3.4).
There are three system prime modes available:
Figure 3.4 Prime Mode Selection Screen
Skip - Select when a prime sequence is not required. When SKIP is selected the
analyser will not perform a prime sequence or auto gain process. Selecting SKIP will
default back to Auto Prime when the current sample run is complete
PLEASE NOTE: SKIP should be used with caution as it may adversely affect
analyser performance.
Full Prime Mode - Select to perform a full prime and auto-gain process at the start of
each run.
Auto Prime Mode (Default setting)- When AUTO PRIME is selected, the analyser
will automatically perform a lamp auto gain sequence. A long or a short prime
sequence will then be performed based on the time intervals specified in the
Maintenance /Autostart (F12) ‘Auto Prime Parameter’ screen. These intervals are
measured from the end time of the last run.
+44 (0) 28 9445 1070
LONG PRIME MODE SEQUENCE
Pump or syringe name Operating period
SWU MX1 Pump for Mix-1 trough ON:18 sec

SWU Water Pump for SPT trough ON: 3 sec
SPP-S1 Syringe for SPP unit Water discharge: 1500µl x 10 times
RPT-water1 Pump for RPT trough ON: 3 sec
RPT-detergent Pump for RPT trough ON: 3 sec
RPP Syringe for RPP unit Water discharge: 2000µl x 10 times
PLEASE NOTE: Total time for long prime sequence is 8 mins 12 secs.
SHORT PRIME MODE SEQUENCE
Pump or syringe name Operating period

SWU Water Pump for SPT trough ON: 1 sec
SPP-S1 Syringe for SPP unit Water discharge: 1500µl x 1 time
RPT-detergent Pump for RPT trough ON: 1 sec
RPP Syringe for RPP unit Water discharge: 2000µl x 1 time
PLEASE NOTE: Total time for short prime sequence is 30 secs (x1 prime) 60
secs (x10 primes).
View the Auto Prime Parameter screen by selecting MAINTENANCE/AUTOSTART

(F12). The default settings for prime sequences will be displayed.
+44 (0) 28 9445 1070
Figure 3.5 Auto Prime Parameter Screen
When Auto Prime is selected the analyser will automatically run one of the following
prime procedures based on the Auto Prime Parameter settings.
Auto Gain Only

If the time between the last measurement and the current measurement is within the
time specified in the ‘Short prime interval’, i.e. less than 60 minutes, then the system
does not require a prime procedure and will simply execute the auto gain adjustment.
Short Prime
If the time between the last measurement and the current measurement exceeds the
time specified in the ‘Short prime interval’, i.e.: greater than 60 minutes, then the
system will perform a short prime sequence with the specified number of short primes
and the auto-gain adjustment.
Long Prime
If the time between the last measurement and the current measurement exceeds the
time specified in the ‘Full prime interval’, i.e. greater than 240 minutes, then the
system will perform the long prime sequence and auto-gain adjustment.
+44 (0) 28 9445 1070
3.2 GENERAL OPERATING PROCEDURE

The following information provides a general overview of the analyser operating
procedure. Recommendations include calibration of assays exceeding their
calibration interval before any patient samples are assayed and running quality
control measurements at least twice daily.
Power on and Automatic system initialisation
Load Reagents onto RCU
Perform RCU scan to register reagents in the system
Enter Calibrator and Control details
Load Calibrators and Controls onto the ASP
Press START.
The system will automatically perform a prime, as specified in
Prime Mode Screen and perform a DTR measurement
Check the results for Calibrator and Control values
Test Selection for Patient Samples.
Load Patient Samples and press Start.

The measurement process will commence.
Obtain Results.
+44 (0) 28 9445 1070
3. 2. 1 LOAD REAGENT/ DILUENTS AND WASH SOLUTIONS

Reagents, diluents and wash solutions are located in the reagent carousel. Up to 40
bottles can be stored in the cooled RCU unit.
1. Remove the reagent carousel from the RCU and place reagents, diluents and
wash solutions in the carousel.
PLEASE NOTE: Bottle caps must be removed before placing bottles in the
carousel.
2. 50 ml or 100 ml bottles are inserted on the inner ring of the carousel.
3. 20 ml bottles are inserted into bottle holders on the outer ring of the carousel.
4. Place bottles correctly into the holders to enable the barcode reader to read the
barcodes.
5. Replace the reagent carousel in the RCU and turn until the guide pin fits into the
specified position.
6. Replace the RCU lid.
PLEASE NOTE: The analyser will not operate if the RCU and ASP lids are not
replaced correctly.
3. 2. 2 REGISTRATION OF REAGENTS, DILUENTS AND WASH SOLUTIONS
3. 2. 2. 1 REGISTRATION OF BARCODED (CLOSED CHANNEL) BOTTLES

Details of Randox closed channel reagents are pre-registered in the software (See
Appendix D for details of how to use the Chemistry Parameter Importing Software to
load assay settings into the analyser software).
After loading the bottles initiate a barcode scan to register the reagent bottles on the
carousel. The system will then offer test options based on the registered reagents.
1. Select RUN MONITOR (F5) / INVENTORY (F11).
2. Select ‘RCU SCAN’.
3. Select START in the pop-up window and the registration of reagents will
commence.
+44 (0) 28 9445 1070
When completed, the software will display the reagent inventory screen complete with
details of the bottles in the RCU.
Figure 3.6 Run Inventory Screen
The position and number of tests possible for each assay is displayed.
If a problem has occurred with the reagent a colour coded warning will be displayed
as follows:
Red - Insufficient reagent inventory

Pink - Reagent expired
Yellow - On-board stability period exceeded
Insufficient Reagent Inventory and Reagent Expired conditions will remove the
relevant test from the RUN MONITOR/TEST SELECT (F5) screen but on-board
stability period exceeded conditions will allow the test to be performed with all results
obtained flagged ‘STB’ to indicate the stability period has been exceeded. Please
note that expired reagents cannot be used on the analyser.
If a reagent bottle does not have a barcode or the barcode is obstructed from the
reader, the analyser will not assign a reagent position on the carousel and will not
display a test parameter on the test selection screen. Furthermore, the parameter will
not be available on the test selection screen if a wash or diluent is enabled in the
+44 (0) 28 9445 1070
chemistry parameters but is not on board the analyser or does not have a readable
barcode. If the barcode label is unreadable it is possible to manually enter the
barcode number printed on the label below the barcode.
Manually enter barcode information

1. Select RUN MONITOR (F5)/INVENTORY (F11).
2. Select Page 2/2 on the screen.
3. Click on the required RCU position.
4. Click on the DELETE button to delete previous reagent details
5. Click SAVE.
6. Double click on the required line in the BARCODE column to enable entry of the
barcode number. Type number exactly as it appears on the barcode label
and press RETURN to confirm. Pre-programmed details will automatically
appear on screen.
7. Click SAVE to store details.
8. To re-set a reagent volume (open channel barcodes only), click on REAGENT
VOLUME and then click on VOLUME RESET. The reagent volume is re-set to full
volume.
PLEASE NOTE: The stability term for open channel reagents is not reset by
using the Volume Reset button.
9. The stability term for each reagent is displayed and indicates the number of days
remaining before the reagent expires. When the reagent has exceeded the
stability term the information is highlighted yellow.
10. Click SAVE.
+44 (0) 28 9445 1070
Figure 3.7 Reagent Inventory Screen (Page 2/2)
3. 2. 2. 2 REGISTRATION OF OPEN CHANNEL BARCODED BOTTLES

Open channel reagent details are not pre-registered and must be registered BEFORE
loading reagents and performing an RCU scan.
1. Select SYSTEM PARAMETERS/SYSTEM (F9). The system parameters are
displayed as shown in Figure 3.8 below.
2. Select ADD in the REAGENT CODE section highlighted on the screen.
Figure 3.8 System Parameters Screen
+44 (0) 28 9445 1070
The reagent information should be entered in the Reagent Registration screen.

Figure 3.9 Reagent Registration Screen
3. Enter the open channel code in the REAGENT CODE field. This is the first two
characters of the barcode only, for example OA.
4. Enter the reagent description in the REAGENT NAME field (up to 6 characters).
5. Click the ENABLE button to activate reagent fields for R1, R2, Wash or Diluent as
appropriate.
6. Enter exact volume of R1 contained in either the large bottle (100ml; Volume L),
medium bottle (50ml; Volume M) or small bottle (20ml; Volume S) as appropriate.
This volume will be used to calculate the number of tests possible from the bottle.
7. Repeat for R2 if necessary. If there is no R2 ensure that the R2 ENABLE box is
de-activated.
8. Click on ENABLE to run a STABILITY CHECK if reagent stability monitoring is
required. Enter a number in the TERM field to indicate the on-board stability
period in days.
9. Click on OK and then click on SAVE on the reagent code screen.
+44 (0) 28 9445 1070
3. 2. 3 REGISTER CALIBRATORS, CONTROLS AND PATIENT SAMPLES

Periodical calibration is required for each item in order to perform stable and accurate
measurement (see kit insert for details). Calibrator and control details need to be
registered in the software. Multi-controls and calibrators can be used for a number of
tests (see section 4.3“CALIBRATION” on page 122 for further details on performing
calibration using single standards (S), multi standards (MS) and automatic
preparation of calibration dilution series from a single standard (SS)).
3. 2. 3. 1 CALIBRATION TYPE
There are two calibration types. The software determines whether a full calibration
(MASTER) or re-calibration (WORK) is performed based on the number of calibrators
placed in the unit. Calibrator samples can be placed in any position in the ASP tray
but are generally placed before patient samples. In non-barcoded mode the calibrator
series must be placed on the ASP in order of increasing concentration (lowest
concentration first). The software will select the calibration type based on the number
of calibrators placed on the sample carousel.
Full Calibration (MASTER)

A FULL calibration is carried out using all calibrators and the results are used to
update the master calibration curve. It is recommended that a full calibration is carried
out for each assay after it has exceeded the defined calibration interval.
Re-Calibration (WORK)
The WORK calibration curve is updated using one or more selected calibrators. The
calibration curve produced with re-calibration is the ‘Work Calibration Curve’. This
curve is used to calculate the final result. In most cases the WORK and MASTER
curves will be the same unless recalibration is carried out. However it is not recom-
mended to re-calibrate with less than the full number of calibrators.
+44 (0) 28 9445 1070
3. 2. 3. 2 CALIBRATION FOR DIFFERENT REAGENT LOTS

2 calibration curves can be stored in the analyser which correspond to different
reagent lots. These are stored as ‘New’ and ‘Old’ calibration curves.
When a full calibration is first carried out the reagent lots used to generate the curve
are displayed under ‘Lot No (R1)’ and ‘Lot No (R2)’ on the CALIBRATION/
CALIBRATION (F9) screen. As this is the first calibration the reagent lots are marked
‘NEW’. If another calibration is performed using the same or different lot numbers the
most recent calibration is then displayed as ‘NEW’ and the previous calibration is
changed to ’OLD’. Switch between the ‘NEW’ and ‘OLD’ calibrations using the
CHANGE LOT button. When switching to a new calibrator lot ensure calibrator values
are changed in both ‘OLD’ and ‘NEW’ fields.
3. 2. 3. 3 DEFINING CALIBRATOR CONCENTRATION

Concentration values of each calibrator must be entered in the software before
calibration is performed.
When a new measurement is initiated, the software will check that a valid calibration
is available for the reagent lots registered in the inventory. If a valid calibration is not
available the results are displayed with a ‘CTR’ flag.
Figure 3.10 Calibration Screen
Test method no.
Lot no.
description
Click here to
enter calibrator
concentrations
Click here Click here to

to recalculate switch between
results OLD and NEW
calibrations
+44 (0) 28 9445 1070
1. Select CALIBRATION (F7) / CALIBRATION (F9).

2. Select a test by moving the cursor on the METHOD field and press the SPACE bar
to view the pop-up menu. A list of parameters will be displayed. The method
number refers to a list of pre-defined tests.
3. Select the required test and press RETURN. If the test has been previously
calibrated the reagent lot numbers for the selected test are displayed on screen.
4. The remaining days of the calibration curve can be manually entered in the
INTERVAL (days) field. This field defaults to ‘0 days’ when the option is not in use.
5. If this option is selected a warning will appear in the TEST SELECTION screen
when the calibration has expired.
6. Click on the CHANGE LOT button to change the lot number description to NEW.
When available, the calibration curve will be displayed on the right of the screen.
7. Click on PARAMETERS to insert calibrator concentrations.
8. Move the cursor to the required field and enter the calibrator concentrations in the
‘CONC’ column. The WORK and MASTER columns will automatically display the
absorbance measurements obtained during the previous calibration.
9. Click on the drop down arrow in the CALCULATION field to select the calibration
curve equation. Click on the required equation type and press RETURN.
10. Click CALCULATE to save the details and display the calibration curve.
PLEASE NOTE: Calibrator concentrations must be entered for each test
parameter.
Figure 3.11 Calibration Screen for Selection of Calibration Calculation Type
+44 (0) 28 9445 1070
Figure 3.12 Concentrations Entered for Linear Calibration
Absorbance values
for WORK and MASTER
Calibrator concentration calibrations
3. 2. 3. 4 K FACTOR
A calibration must usually be performed with a calibrator of known concentration so
that a calibration curve may be constructed from which the concentration of unknown
samples can be determined. For some assays the reaction is always linear and a
factor may be used to calculate the results of unknown samples. In this case a
calibration does not need to be performed, however it is recommended that a factor is
established via a linear calibration.
PLEASE NOTE: It is recommended that enzymes are calibrated using a linear

calibration
To use a factor to calculate results select FACTOR for the calibration calculation type.
enter the factor in the K field of PARAMETERS pop-up window.
+44 (0) 28 9445 1070
Figure 3.13 Selection of FACTOR Calibration Type
Select factor
calibration type
Enter K factor
When the factor option is selected the concentration of an analyte is calculated using
the following equation:
C=KxA+B
where
C= Concentration
A= Measured Absorbance
K Factor = (pre-defined factor)
B =Reagent Blank Concentration.
By defining the parameter K, the concentration (C) of the analyte can be determined.
This conversion method is called ‘K-Factor’.
3. 2. 3. 5 RECALCULATION OF RESULTS
Patient results can be re-calculated from an absorbance measurement using either a
WORK or MASTER calibration curve. This option is useful when developing a user
defined open channel assay.
1. Select the required calibration type.
2. Click on RECALCULATE on the SYSTEM (F9) screen. This will recalculate the
concentration of individual samples using the selected type. A pop up screen will
appear.
+44 (0) 28 9445 1070
3. Select either WORK or MASTER in the TYPE field and enter the sample
absorbance value.
4. Press RETURN on the keyboard. The software will automatically re-calculate the
absorbance value of the sample. The value will be presented on screen in the
CONC field.
5. Repeat the process for each sample value. The software will NOT store the
re-calculated values.
6. Click CLOSE to exit.
Figure 3.14 Recalculate screen for absorbance values
3. 2. 3. 6 DEFINITION OF CALIBRATOR CONDITIONS OF MEASUREMENT

The measurement conditions default to predefined values for closed channel assays
but may be changed as required.
+44 (0) 28 9445 1070
Figure 3.15 Calibration Measurement Conditions
1. Select CALIBRATION (F7) / CHECKS (F10). The software will display a list of
settings for measurement limits.
2. Move the cursor to the METHOD field and press the SPACEBAR to view the test
list.
3. Select the required test and press RETURN.
4. Select the number of replicates for standards by selecting either DUPLICATE or
TRIPLICATE in the ‘Sampling method for standard’ field.
5. Click on the required option in the ‘Reagent Blank Measurement’ field. The
options include DISABLE REAGENT BLANK AND S1 BLANK, ENABLE S1
BLANK (FACTOR OR LINEAR), ENABLE REAGENT BLANK and ENABLE
REAGENT BLANK FOR S1 LINEAR.
6. If ENABLE REAGENT BLANK is activated, the frequency of the reagent blank
must be specified. Click on the scroll bar to display the following options:
Daily
Next Run
None.
7. In the ‘REAGENT BLANK MEASUREMENT AT CALIBRATION’ field select the
reagent blank type (No Sample or System Water).
8. Click SAVE to save the new settings.
+44 (0) 28 9445 1070
3. 2. 3. 7 Measurement of Reagent Blank During Run

Only one reagent blank is performed during a run however if ‘MULTIPLEX
MEASUREMENTS’ IS THE SAME AS STANDARDS’ is selected then the number of
reagent blanks performed is identical to the ‘SAMPLING METHOD FOR
STANDARDS’ i.e. duplicate or triplicate.
Reagent blank interval

Daily Reagent blank performed each day
Next run Reagent blank performed at beginning of next run.
None Reagent blank not performed until next calibration.
Reagent blank Interval Date of last run
Reagent blank type
Reagent blank type

There are two types of reagent blank available:
• Reagent blank with no sample R1 + R2
• Reagent blank with system water R1 + R2 + x µl system water
(x = sample volume).
Reagent Blank Duplicate Limit

A duplicate limit check for duplicate or triplicate reagent blanks may be set as follows:
1. In the ‘REAGENT BLANK LIMIT CHECKS’ field click on ‘DUPLICATE LIMIT’ to
activate the limit check.
2. Click on the relevant field and enter the required absorbance level mAbs/10.
+44 (0) 28 9445 1070
Figure 3.16 Definition of Blank Limit Checks
Enter a value between 1 and 35000mabs / 10
Calibration and Reaction Limit Checks

There are several limit checks available for the calibration and reaction that detect if
the reaction has taken place within the acceptable limits. Flags are displayed on the
calibration report or results screen for those measurements outside acceptable limits.
Please note these limits are predefined for closed channel assays and it is
recommended that they are not altered.
Figure 3.17 Limit Checks
Duplicate Limit: This is the maximum acceptable absorbance difference between

duplicate and triplicate measurements.
Enter a value between 1 and 35000mabs / 10.
+44 (0) 28 9445 1070
Duplicate
If the calibrators are measured in duplicate and the duplicate limit is exceeded, a DUP
flag will be printed and the calibration will fail.
Triplicate
If the calibrators are measured in triplicate and 1 result exceeds the limit and the other
two are within the limit, the third value will be excluded and only the two acceptable
values will be used for the calculation. If calibrators are measured in triplicate and two
of the three measurements are outside the duplicate limit, a DUP flag will be printed
and the calibration will fail.
Sensitivity Limit Enter a value between 0 and 35000mabs / 10.

The minimum acceptable absorbance difference between first and last calibrators in a
series. If the difference in absorbance between the first and last calibrator in a series
is less than the sensitivity limit a SENS flag will be printed and the calibration will fail.
Linearity Limit
The linearity of kinetic assays (RATE calculation) is calculated by measuring the
deviation of the reaction curve from the linear behaviour. If the specified value is
exceeded a LIN flag is displayed beside the result, indicating that the sample has
failed the linearity check.
+44 (0) 28 9445 1070
Figure 3.18 Calculation of Linearity Limit
Change 4 measurement points by the

calculation using the moving average.
Calculate slope by the least squares method
The linearity value L is the difference in absorbance change between the first four and
the last four measured points (of the measuring range defined in chemistry
parameters) as a percentage of the total slope of the measuring range. If the linearity
value exceeds the given linearity value (chemistry parameters), the result is flagged
with LIN.
Formula of linearity value L in %:

Δ ABS first – Δ ABS last
L = ------------------------------------------------------ × 100%
Δ ABS total
+44 (0) 28 9445 1070
ΔABSfirst and ΔABSlast are both differences between two ABS values. ΔABStotal is
calculated using the least squares method as described above. The water blank
corrected absorbance values are used. Absorbances are in mAbs/min.
The linearity check is not performed in the following cases:
(1) The number of measuring points in the measuring range used for calculation of
ΔABStotal is 4 or less
(2) Δ ABS total ≤ x (mABS/min)
(3) Δ ABS first – Δ ABS last ≤ x (mABS/min)

The value of x should be specified for each assay.
Absorbance Limit (Applies to the rate method only).

Enter a value between 1 and 35000 mabs / 10. This is the maximum allowable
absorbance obtained during the measuring range for an increasing reaction and the
minimum allowable absorbance obtained during the measuring range for a
decreasing reaction. If the absorbance at one or more of the measuring points
exceeds the limit the results will be recalculated based on the remaining points that
are within the limit, providing there are three or more points within the limit that can be
used in the calculation. The flag AB2 will then be printed with the result.
If there are less than 3 points within the absorbance limit, no result will be calculated
and the flag AB1 will be printed.
+44 (0) 28 9445 1070
The limit of the curve is defined in mAbs/10

Selecting the ‘Increase’ reaction curve gives the increasing absorbance
over measuring time and selecting ‘decrease’ gives the decreasing absorbance
over measuring time.
Increase: Absorbance values greater than the limit value are

disregarded.
Decrease: Absorbance values lower than the limit value are
disregarded.
3. 2. 3. 8 QUALITY CONTROL SAMPLES

The software enables registration of up to 30 quality control sample types.
1. Select QC (F8)/CONTROL (F12).
2. Move cursor to the Control ID field and type the control ID number (select from
C1-C30).
3. Move cursor to the NAME field and enter a user-defined name for the control (e.g.
Level 2, 236UN). Tests that have already been registered will be visible on screen.
4. Click SAVE to save the information.
+44 (0) 28 9445 1070
Figure 3.19 QC Registration Screen
Control ID no.
Control name
Test names listed

for pre-registered
controls
When the QC sample name has been registered, the registration of tests to be
performed on each QC sample has to be carried out. For each analyte the mean
value and SD for the QC sample must be entered so that a Levy-Jennings plot and
QC statistics can be generated as follows:
1. Select QC (F8) on job menu.
2. Select QC SETTINGS (F11) on function keys.
3. Move the cursor to the METHOD field and press the SPACE bar to view the list of
test methods.
4. Click on a name to select a test method and press RETURN. The software will
automatically display any previous QC results for the different levels.
5. Enter the required information by clicking on the required field and entering the
values for mean and SD.
6. Select QC rules as follows:
(a) Click on the scroll bar adjacent to the required rule and the following options
will appear
INACTIVE
ERROR
WARNING.
(b) Click on the required option and the rule will be activated.
+44 (0) 28 9445 1070
Figure 3.20 QC Settings
MULTI-RULE selection List of registered QC samples
Method
Enter the method number. When method numbers 61 and 62 are entered the ISE
testing box will be displayed.
Name
Method name (automatically defined by the method number entered).
Interval
QC interval in days. If a QC sample for this analyte is not measured within this period,
the test button in RUN MONITOR / TEST SELECT screen will be displayed yellow.
Control ID
Enter the required Quality Control sample number from the list displayed on the right
of the screen.
+44 (0) 28 9445 1070
Control Name
Enter the QC sample name (automatically defined by the control ID number entered).
Mean Value
Enter the mean concentration of the QC sample.
SD
Enter the standard deviation of the QC sample. The standard deviation range is
plotted as dotted lines on the graphic display.
Rules (QC Multi-rules)

The standard deviation limits are plotted in dotted lines on the graphic display.
QC Multi-rules are used to define the judgement condition of the QC results. The
options are as follows:
- Current result exceeds 2SD - Current result exceeds 3SD

- Current result exceeds 4SD - Last 2 results exceed 2SD
- 2 out of last 3 result exceeds 2SD - Range exceeds 4SD
- Any 3 results exceed 1SD - Any 4 results exceed 1SD
- 10 results same side of mean - 7 continue point trend
For each test there is an option to select any combination of the ten rules displayed
above. Select one of the following - INACTIVE, WARNING, or ERROR.
INACTIVE – The software will default to this option and the adjacent QC Multi-rule will
not be applied.
WARNING – When this option is selected the software will display any QC result that
violates the rule as a YELLOW dot on the QC chart. These results will be included in
the overall mean and SD statistics displayed on the QC chart.
+44 (0) 28 9445 1070
ERROR – When this option is selected the software will display any QC result that
violates the rule as a RED dot on the QC chart. These results will NOT be included in
the overall mean and SD statistics displayed on the QC chart.
3. 2. 4 TEST SELECTION FOR BARCODED PATIENT SAMPLES

The user must specify for each sample which tests to perform on the RUN MONITOR/
TEST SELECT (F10) screen. The procedure for selecting tests varies depending on
whether the sample barcode is enabled or disabled (SYSTEM PRM/SYSTEM). This
section describes the procedure for barcoded samples (see section 3.2.6 for details of
test selection with non-barcoded samples).
The software also provides the facility to download test sample selection information
directly from a host computer.
Figure 3.21 Test Selection for Barcoded Samples
1. Select the BARCODE box if barcodes are to be used to enter patient sample
details. (maximum 12 digits for barcode).
2. Select the Paediatric cup box if the sample is a reduced volume paediatric
sample. (Maximum 4 digits).
+44 (0) 28 9445 1070
3. Enter sample number details (N (normal): 3-12 characters, R (replicate): 2

characters). A replicate barcode must be used for a Replicate sample. See
section 3. 2. 5. 4. 3“Information on Sample Barcode” on page 90.
4. Select which normal range is to be applied to the sample.
Method Options
Standard: Mask method selection for standard.
MS: Mask method selection for multi-standard.
QC: Mask QC method selection
Profile: Mask the profile items.
Blank: Mask method selection for blank measurement.
Save: Save selection.
Cancel: Cancel selection.
Copy: Copy test selection.
Delete: Delete test selection from list.
List: List stored test selection
Emergency: Change to Emergency test selection screen
Online order: Request the test selection data from host when ’On Line
Batch1’ or ’On Line Batch2’ mode is enabled in the
Condition (F12)/ Run Monitor (F5) screen.
3. 2. 4. 1 NORMAL / REPLICATE SAMPLE TEST SELECTION

Normal patient samples and replicate samples are selected by entering the relevant
barcode number and then confirming tests to be performed. Number of replicates
must be defined in the SYSTEM PRM / SYSTEM / PAGE2 screen.
Manual Test Selection Procedure

1. Select RUN MONITOR (F5) from the job menu.
2. Select TEST SELECT (F10) from the function key menu.
3. Ensure that page number 1 of 2 is selected (change the page number by clicking
on the page number button).
+44 (0) 28 9445 1070
4. Move the cursor to the ‘SAMPLE NUMBER’ field and click on either ‘N’ (Normal
sample) or ‘R’ (Replicate sample). Replicate sample is selected if the sample
measurement is repeated.
A replicate barcode must be used for replicate samples.
5. Select the BARCODE option to enter the barcode details via a barcode reader.
6. Select a PAEDIATRIC CUP for analysis of a paediatric sample (low volume).
7. Enter the sample number as printed on the barcode label. For a Normal sample a
3 to 12 digit numerical code from 001 to 999999999999 is acceptable. Do not use
codes from 94000001 to 99999999 for patient samples.
8. For replicate samples enter a sample number from 1 – 99 as shown on the
barcode label. (For a replicate sample enter the number of repetitions from 1 to 40
(maximum of 40 times) in the SYSTEM PRM/SYSTEM(F9) (PAGE 2 of 2)
9. Enter a PATIENT ID if required (3 to 12 alphanumeric characters).
10. A window will appear on screen asking the user to ‘Enter sample information
data’. Click on OK if full patient demographic details are required or CANCEL if the
patient details are not required. For more information on the patient information
facility see section 4. 4. 9. 4“Entry of Patient ID at Test Selection” on page 163.
11. Click on the NORMAL range field to specify the range required. To use the
standard normal range values select a blank field. To specify an extension normal
range click on the arrow and select the item of choice. The extension normal
ranges may be set in CHEMISTRY PRM / CHEMISTRY.
12. Click on the reagent code button. The selected tests will be highlighted in bright
blue on screen. Method codes are displayed on screen for reagents present in the
RCU.
PLEASE NOTE: Methods using a diluent will NOT appear for selection
unless the diluent is registered on the analyser.
ISE measurements and test profiles are selected in the same way. Multiple method
selection can be made for each sample.
Methods are flagged with different colours to warn the user as follows:
RED (general methods) Calibration has expired
RED (ISE) No valid ISE calibration stored
YELLOW QC interval has been exceeded
+44 (0) 28 9445 1070
13. Click on SAVE to confirm selection. The Sample Number field will automatically
increase by one in preparation for the next sample entry.
3. 2. 4. 2 COPYING TEST SELECTIONS FOR BARCODED SAMPLES

When a number of samples are presented for the same test profile, the test sample
selection details may be applied to the samples using the COPY facility. The first
sample must have already had a test sample selected and saved before the copy
facility is used. After a test menu is entered for a sample follow the instructions below.
Figure 3.22 Copying Test Selection to Other samples
3. 2. 4. 2. 1 Copying Test Selection for Normal Sample

1. Click on COPY.
2. In the COPY FROM SAMPLE NUMBER field enter the sample number (minimum
3 digits) for the selected test.
3. In the COPY TO SAMPLE NUMBERS field enter the sample numbers (minimum 3
digits) in the COPY FROM and COPY TO fields.
4. Click on COPY. The software will allocate the same test selection to the sample
numbers entered in the COPY screen.
3. 2. 4. 2. 2 Copying Test Selection for Replicate Sample

1. Click on COPY.
2. In the COPY FROM SAMPLE NUMBER field enter the sample number (minimum
2 digits) for the selected test.
3. In the COPY TO SAMPLE NUMBERS field enter the FROM and TO sample
numbers (minimum 2 digits).
+44 (0) 28 9445 1070
numbers entered in the COPY screen.
3. 2. 4. 3 DELETING TEST SELECTIONS FOR BARCODED SAMPLES

This facility offers the option to delete a test selection before starting the run.
1. Click DELETE.
2. In the DELETE field enter the FROM and TO numbers of samples that require
deleting.
3. Click DELETE ALL to delete all selected test selection profiles.
Figure 3.23 Deleting Test Selection for Barcoded Samples
3. 2. 4. 4 MASKING OPTION (BARCODED AND NON BARCODED SAMPLES)

Functions are available within the software that allow multiple tests to be selected for
particular sample types e.g. tests to be performed on QC samples are defined in the
QC Settings (F11) screen as described in Section 3. 2. 3. 8“Quality Control Samples”
on page 73. The mask feature allows the tests to be performed for the following run to
be modified without permanently changing the method selection for that function (see
section 3. 2. 4“Test Selection For Barcoded Patient Samples” on page 77).
Procedure:
1. Click on the MASK selection button (Standard, MS, QC, Profile or Blank). A mask
screen will be displayed (see figures 3.21 to 3.25).
+44 (0) 28 9445 1070
Figure 3.24 Mask Option for Standard (Normal sample)
All options will be automatically highlighted. Click on all options that do not require a
calibration to de-select them. A calibration will only be performed on highlighted
options.
Figure 3.25 Mask Option for MS (Multi-standard)

Click here to select
Multi-standard
All analytes selected in the calibration screen (See section 4. 3. 3“Register Multi-
calibrator Details (MS)” on page 125) will be automatically highlighted. Click on any
option to de-select. A calibration will only be performed on highlighted options.
+44 (0) 28 9445 1070
Figure 3.26 Mask Option for MS (Multi-standard) with de-selected options
Figure 3.27 Mask Option for QC (QC control)
All analytes selected on the QC screen (See section 3. 2. 3. 8“Quality Control

Samples” on page 73) will be automatically highlighted. Click on any option to de-
select. QC will only be performed on highlighted options.
Figure 3.28 Mask Option for Profile
All analytes ticked in the Profile screen (See section 4. 4. 4“Test Profile” on page 144)
will be automatically highlighted. Click on any option to de-select. A test will only be
performed on highlighted options.
+44 (0) 28 9445 1070
After selecting valid item(s), select one of the following.

Save Save masked item(s).
Cancel Cancel masked item(s).
Close Close mask screen.
PLEASE NOTE: the selected MASK options only apply to the next run. The
software will default to full test selections in subsequent runs.
Figure 3.29 MASK OPTION FOR BLANK
All analytes with ’Enable S1 blank (Factor or Linear)’ set in the Calibration Checks
(F10) screen are automatically selected. Click on an analyte to deselect. An S1 blank
will only be performed on highlighted options.
3. 2. 4. 5 CONFIRMATION OF TEST SELECTIONS

The registered test selection can be displayed, confirmed and corrected as follows:
1. Click on LIST. A list of all test selections is displayed on screen. Selected tests are
displayed in blue, non-selected tests displayed in black and tests not available for
selection are displayed in grey.
2. To select/deselect a test, move the cursor to the relevant test and press the
SPACE bar.
3. Click on JUMP (see figure Figure 3.28“Mask Option for Profile” on page 83) to
quickly find the defined sample number in a large list.
4. Click CLOSE to save changes.
+44 (0) 28 9445 1070
Figure 3.30 Confirmation or Alteration of Test Selections
3. 2. 4. 6 CALIBRATION AND CONTROL EXPIRY ALARM

Expiry of the Calibration interval or the QC interval is indicated in the test selection
screen. Tests will be displayed in colour depending on which interval has expired.
RED - Calibration interval expired
YELLOW - QC setting interval expired
RED (ISE) - No stored ISE calibration
If intervals have expired a new calibration or QC run is required. If this is not carried
out the sample will be analysed and the results will be flagged.
PLEASE NOTE: if the ISE button is displayed in RED an ISE Calibration must be
performed to obtain results for ISE measurement.
+44 (0) 28 9445 1070
3. 2. 5 LOADING CALIBRATORS, CONTROLS AND BARCODED PATIENT

SAMPLES
Load calibrators, controls and patient samples onto the ASP carousel.
The ASP rotates in a counter clockwise direction and samples are aspirated in the
order in which they reach the SPT position. Place samples according to the following
guidelines:
• Place calibrators in front of patient samples.
• Calibrators in a series should be placed in any order of concentration.
• Quality Control samples can be placed in any position but ideally should be placed
after the calibrators.
• When appropriate, CAL B or wash solution should be placed at position 18 on the
ASP.
All samples are identified by barcodes. Sample tubes should be placed in the rack
with the barcodes positioned so they can be clearly identified by the barcode reader.
The carousel can accommodate a total of 40 samples (normal, emergency, quality

control, standard) in sample cups or sample tubes.
3. 2. 5. 1 SAMPLE TUBES
The following sample tubes can be used.
Diameter: 13 mm ~ 16 mm
Length: 75 mm ~ 100 mm
Ensure that barcode labels are applied correctly to the sample tubes. This enables
the barcode reader to identify the sample. (See section 4 “ACCESSORY
FUNCTIONS” on page 111).
3. 2. 5. 2 SAMPLE CUPS
Sarstedt Tube - Cat No. 55.472 - Tube 6.5ml 85 x 13mm PS
Sample cups may be used in the analyser by placing them in a barcoded patient
sample tube as shown. The sample tube with cup can be loaded into the ASP
carousel and identified by the barcode on the sample tube.
+44 (0) 28 9445 1070
3. 2. 5. 3 PAEDIATRIC CUPS
Sarstedt Cup- Cat No. 72.730.006- Micro tube 0.5ml PP
Dedicated cups are available for paediatric sample analysis. Dedicated screw cap
cups (46mm x 10.8mm) are inserted in the accompanying tubes (85 x 13mm).
Barcodes may be placed on the accompanying tube which can be loaded directly
onto the ASP.
Figure 3.31 Placement of Sample Cup in Sample Tube with Barcode
3. 2. 5. 4 SAMPLE BARCODES
Barcode labels should be attached to all sample tubes. When sample cups are used
the barcode label should be attached to the adapter tube, as shown (12.5-14.5mm
from the bottom of the tube).
Check digits are incorporated in barcodes of control samples and calibrators for
identification purposes. Normal and emergency samples may carry check digits
depending on the system menu requirements.
Positioning of barcode labels on the sample tube or reagent bottles must adhere to
the recommendations described in this manual. Deviation from these specifications
will present problems for the barcode reader.
+44 (0) 28 9445 1070
3. 2. 5. 4. 1 SPECIFICATIONS OF SAMPLE BARCODE LABEL

Item Description
Barcode symbol NW-7, Code39, ITF, UPC, Code128 (Set A, B, C)
Maximum number of The label must meet the following Bar module and
digits Barcode printed area.
The allowable maximum number of digits is different
depending on symbols.
NW-7
Code39
ITF
UPC
Code128 (Set A)
Code128 (Set B)
Code128 (Set C)
Bar module 1) Thin bar > or = 0.3 mm
2) Thin bar : thick bar = 1 : 3 (1 : 2.5 – 1 : 3)
3) Thickness of bar > or = 10 mm
Barcode printing 1) Printing area 0.3 mm or higher
range 2) Barcode label length 57mm or lower
3) Blank areas of 5 mm are provided at both sides of
barcode
Printing 1) Black print on white background
2) Numerical coding information beside barcode
3) Print on thermal paper unacceptable to prevent
deterioration with time
4) Quality level: ANSI MH10.8M
Positioning of 1) No obstruction between barcode reader and barcode
barcode label 2) Distance between the lower end of the label and
bottom of the tube is 12.5 – 145mm.
3) Inclination: within ±1 °
+44 (0) 28 9445 1070
Figure 3.32 Barcode Label Fixing Specifications
5mm
47mm
Printable
abc
Barcode
Area
5mm
12.5- 14.5 mm
3. 2. 5. 4. 2 TYPES OF BARCODE LABEL

The following sample barcode labels are used.
Normal sample
Barcode labels for normal samples have sample numbers from 4 to 12 digits.
The numeric 4 -12 digit codes (0001 to 999999999999) can be used for normal
samples (except codes 89990000 to 99999999).
Emergency sample
The numeric 8 digit codes (99000001 to 99000999) can be used for emergency
sample barcode labels.
Replicate sample
This barcode label is used when a sample is measured repeatedly.
The barcode is defined as 9400nn01, where nn is from 01 to 99.
Quality control sample

The numeric 8 digit codes (97000001 to 97000999) can be used for Quality Control
barcode labels.
Standard (Calibrator)
The numeric 8 digit codes (98000001 to 98999997) can be used for Calibrator
barcode labels.
+44 (0) 28 9445 1070
3. 2. 5. 4. 3 INFORMATION ON SAMPLE BARCODE
A Emergency sample, Calibrator, Control sample
Digits Code information Description
1–3 Sample type On screen:

990: Emergency sample Emergency sample: E
970: Control sample Control sample: C
I
4,5 00
6–8 Sample number For example, 99000001 to E001

001 – 999: Emergency sample
001 – 999: Calibrator
001 – 999: Accuracy control sample
B-1 Standard (assigned for single method)

980: Calibrator Calibrator: S
4 -5
6-7 Method code Two digit method code registered at

’System parameter’ screen
8 Standard number For example, 98050011 to S01

1–7
B-2 Multi-standard (assigned for multiple methods)

950: Calibrator Calibrator: MS
4-6 000
7 Standard set number Refer to the table below

0-9
8 Standard number For example, 95000011 to M01

1–7
+44 (0) 28 9445 1070
The standards can be grouped as follows:

Set Code Barcode
1 M01 – M07 95000001 – 95000007
2 M11 – M17 95000011 – 95000017
3 M21 – M27 95000021 – 95000027
4 M31 – M37 95000031 – 95000037
5 M41 – M47 95000041 – 95000047
6 M51 – M57 95000051 – 95000057
7 M61 – M67 95000061 – 95000067
8 M71 – M77 95000071 – 95000077
9 M81 – M87 95000081 – 95000087
10 M91 – M97 95000091 – 95000097
B-3 Standard series

1-3 Sample type: On screen:

930: Standard Series Calibrator: SS
4,5 00
6,7 Reagent code For Example, Albumin: A2
8 0
C-1 Normal sample (Online/Offline)

1 – 12 Sample number Any number of digits may be used within 4

– 12 digits.
Except for the ones starting with 950 to 990:
invalid due to being reserved as section A
and B.
C-2 Normal replicate sample


940: Replicate sample Replicate sample: R
4 0
5,6 Sample number

01 – 99: Replicate sample
+44 (0) 28 9445 1070
7, 8 01 Fixed to ’01’. All numbers other than ’01’

Sequence number will be ignored as the analyser will automat-
ically generate ’02’ and further numbers
depending on the setting at ’Condition’
screen.
D One Point Calibration Sample

951: One point calibration sample One point cal sample: S1
4,5,6 0
7,8 Sample number

01 – 99: One point cal sample
E1 Paediatric Sample (Normal)

8999 Paediatric sample:
5-8 Any number
E2 Paediatric Sample (Emergency)

990009 Paediatric sample:
7-8 Any number
E3 Paediatric Sample (Replicate)

94006 - 94009 Paediatric sample:
6 Any number
7-8 01
+44 (0) 28 9445 1070
3. 2. 5. 4. 4 LABEL ERROR CHECK OF SAMPLE BARCODE

The analyser will not sample from a tube if the barcode check digit displays an error.
1. When barcodes contain digits outside the ranges defined in the above tables, an
alarm flag will appear and sampling will stop.
2. When 2 or more samples carry the same barcode within a sample run, the first
sample is valid and the subsequent samples are rejected and not sampled.
3. Normal samples can be placed in any order.
3. 2. 6 TEST SELECTION FOR NON-BARCODED PATIENT SAMPLES

Information on sample type and tests can be entered manually for non-barcoded
samples, or samples received from a host.
PLEASE NOTE: The barcode option MUST be disabled when non barcoded
samples are run. To disable the barcode option go to SYSTEM PARAMETERS/
SYSTEM (F9) and go to SAMPLE BARCODE. Click on the DISABLE option and
click OK on the pop up window.
3. 2. 6. 1 ENTER INFORMATION FOR NON-BARCODED SAMPLES.

1. Select RUN MONITOR (F5)/TEST SELECT (F10).
2. Click on the required sample position on the left of the screen. The selected
position will be highlighted in blue.
3. Click on the required sample TYPE from the following list.
E Emergency sample
N Normal sample (single run)
S Single standard (calibrator)
MS Multi standard,
SS Standard series
B Blank sample
C Control sample
R Replicate sample
+44 (0) 28 9445 1070
4. The sample number will be automatically displayed. Enter a different sample

number if required (3 to 12 digits except 90000000 to 99999999) in the ‘SAMPLE
NUMBER’ field. Click on PATIENT ID and enter the ID number if required.
5. A box will appear on screen prompting the user to ‘ENTER SAMPLE
INFORMATION DATA’. Click OK if you wish to enter full patient demographic
information or CANCEL if this option is not required. (See section 4. 4. 9. 4“Entry
of Patient ID at Test Selection” on page 163).
Single Standard - When selected the user must select the number of standards
required (1 to 7) from the box adjacent to the sample selection box. Positions on the
ASP are automatically reserved for the calibrator(s) and displayed in PINK on screen.
Multi-standard – When selected the user must select the set of multi standards
required (M1 to M10) from the drop down menu The system will display the number of
standards programmed as multi-standard. Positions on the ASP are automatically
reserved for the calibrator series and displayed in PINK on screen when a
multi-standard is selected.
Standard Series – The user can choose only one test per Standard series. Click on
the sample position required, click on SS and then select the test option required.
Click on the SAVE button.
Control Sample – Click on sample ‘C’ and the software will display a list of the
registered control samples. Specify the number of the required control sample as
shown.
+44 (0) 28 9445 1070
Figure 3.33 List of Registered Control Samples
Replicate Sample – When the ‘R’ sample is selected, enter the replicate sample
number required e.g. 01- 03.
For NORMAL And EMERGENCY samples follow the instructions described below.
1. Click on NORMAL RANGE to specify the range. The default ‘BLANK’ selection
will apply the most common Normal Range. Extension. Normal Ranges are also
applicable (as set up in Chemistry Prm (F6)/Chemistry (F9) screen).
2. Move the cursor to the NORMAL RANGE field and click to display the list of
ranges as shown below. Click on the required option and the software will apply
this range to the results.
3. Click on ‘PAEDIATRIC CUP’ to activate the option and notify the software that the
sample is presented in a paediatric cup. To de-activate, click on the box again.
+44 (0) 28 9445 1070
4. Click on the required sample tests. The selected tests will be highlighted in blue.
To deselect a test click on the test option again and the selection will be reversed.
Only methods registered on board are available for selection.
PLEASE NOTE: Methods using a diluent will NOT appear for selection
unless the diluent is registered on board the analyser.
ISE measurements and test profiles are selected in the same way. Multiple
method selection can be made for each sample.
Methods are flagged with different colours to warn the user as follows:
RED (general methods) Calibration has expired
RED (ISE) No valid ISE calibration stored
YELLOW QC interval has been exceeded
5. Click SAVE to confirm selection. The sample position will automatically move to
the next sample.
Figure 3.34 Test Selection for Non-barcoded Samples
+44 (0) 28 9445 1070
3. 2. 6. 2 COPYING TEST SELECTIONS FOR NON-BARCODED SAMPLES

When the same test profile is required for a number of samples, the test selection
details may be copied from one position to another using the COPY facility.
The test selection for the first sample must be already saved before the copy facility is
used. Please note the example given is for a Normal patient sample – other types of
samples will have different sample numbers.
1. Click on COPY. If the COPY option is not displayed click on the sample position
for which test selection is complete.
2. In the COPY FROM field enter the sample number for the selected test.
3. In the COPY TO POSITIONS - FROM field enter the sample numbers (1-40) and
then enter the corresponding three digit number in the adjacent sample number
field (001 – 040).
4. In the COPY TO POSITIONS - TO field enter a sample position number (1-40).
position numbers selected.
Figure 3.35 Copying Test Selection to other Non-barcoded Samples
+44 (0) 28 9445 1070
3. 2. 6. 3 DELETING TEST SELECTIONS FOR NON-BARCODED SAMPLES

Test selections are automatically deleted when the analyser is restarted and a new
date is displayed.Test selection will be automatically deleted for successfully
completed tests.
1. Select the sample position.
2. Click on DELETE. The software will automatically delete details from the current
sample position. Repeat for each sample position, if required.
3. Click on DELETE ALL to delete all test selection profiles.
Figure 3.36 Copy and Deletion Screen for Test Selection Profiles for
Non-barcoded Samples
3. 2. 6. 4 CONFIRMATION OF TEST SELECTIONS

To display the test selections:
1. Click on LIST (see Figure 3.21“Test Selection for Barcoded Samples” on
page 77). A list of all test selections is displayed on screen. Selected tests are dis-
played in blue and non-selected tests displayed in black. Tests not available for
PLEASE NOTE: Test selections on this screen are for viewing purposes only
and cannot be altered.
2. Click on CLOSE to exit the list screen.
+44 (0) 28 9445 1070
Figure 3.37 Test Selection Screen
3. 2. 6. 5 CALIBRATION AND CONTROL EXPIRY ALARM

Expiry of the Calibration interval or the QC interval is indicated in the test selection
screen. Test names will be displayed in different colours according to which interval
has expired.
RED Calibration interval expired

YELLOW QC setting interval expired
RED (ISE) No valid ISE Calibration stored
If these intervals have expired a new calibration or QC run is required. If this is not
carried out the sample will be analysed and the results will be flagged.
PLEASE NOTE: If ISE button is displayed in RED, ISE calibration MUST be

performed to obtain results for ISE measurement.
3. 2. 6. 6 CAUTIONS IN MAKING TEST SELECTIONS (NON-BARCODE MODE ONLY)

Ensure test selection for all measurements are automatically deleted when the tests
have been completed. If the test selection is not deleted using the “DELETE TEST
SELECTION” window of the “TEST SELECTION” screen, the same samples (if set in
the unit) will be measured again.
+44 (0) 28 9445 1070
3. 2. 6. 7 MASKING PROCEDURE
The Masking procedure is identical for both barcoded and non-barcoded sample
modes (see Section 3. 2. 4. 4“Masking Option (Barcoded and Non Barcoded
Samples)” on page 81 for further details).
3. 2. 7 LOADING CALIBRATORS, CONTROLS AND NON-BARCODED PATIENT

SAMPLES
Load calibrators, controls and patient samples into the ASP.
The ASP rotates in a counter clockwise direction and samples are aspirated in the
order in which they reach the SPT position. Place samples in the ASP carousel as
follows:
1. Place calibrators in front of patient samples.
2. Calibrators in a series should be placed in increasing order of concentration.
3. Quality Control samples can be placed in any position but ideally should be placed
after the calibrators.
4. CAL B or wash solution (if appropriate) should be placed at position 18 on the
ASP.
The analyser can accommodate a total of 40 samples (Normal, Emergency, Quality
Control, Standard) in sample cups or sample tubes.
3. 2. 7. 1 SAMPLE TUBES
The following sample tubes can be used:
Diameter: 13 mm ~ 16 mm
Length: 75 mm ~ 100 mm
3. 2. 7. 2 SAMPLE CUPS
(Sarstedt Cup: Cat No. 55.472 :Tube 6.5ml 85 x 13mm PS)
Sample cups may be used by placing them inside a sample tube. The sample tube
with cup can be loaded into the ASP carousel.

+44 (0) 28 9445 1070
Figure 3.38. Placement of Sample cup in Sample Tube
3. 2. 7. 3 PAEDIATRIC CUPS
(Sarstedt Cup: Cat No. 72.730.006 :Micro tube 0.5ml PP)
Dedicated cups are available for paediatric sample analysis. Dedicated screw cap
cups (46mm x 10.8mm) are inserted into the accompanying tubes (85 x 13mm), in the
same way as sample cups (see Figure 3.35 above). Barcodes may be placed on the
accompanying tube which can be loaded directly into the ASP.

+44 (0) 28 9445 1070
3.3 START ANALYSIS

1. Press START (F1) to commence analysis.
2. A pop up window will appear to remind the user to perform water, waste and wash
bottle checks.
3. Click OK,
The system will now begin analysis.
Analysis progress is displayed on the right of the RUN MONITOR/ RUN
MONITOR(F9) screen. The sample status is displayed using a colour-coded system
at each sample position on the left of the screen. The instrument status is indicated in
the STATUS field on the top left corner of the RUN MONITOR screen (see Figure
3.37 below).
Figure 3.39 Run Monitor Screen
The RUN MONITOR screen also provides the following information:

1. Number of tests run – Does not include QC or calibrator tests.
2. Incubation temperature – Displays current temperature in the IRU.
Sample measurement will not proceed if the temperature is outside the specified
range (37 ± 0.5ºC).
3. Start time and estimated end time of run – QC and calibrator samples will not be
taken into account.
4. Colour-coded system used for sample carousel.
Green – Sampling Started
Dark Blue – Range Over

+44 (0) 28 9445 1070
Purple – Re-run Required

Red – Error
Light Blue – Process Complete
White – Not Processed
Yellow – No test Ordered
During operation the START (F1) button will flash yellow to notify the user that the
system is busy.
3. 3. 1 MONITORING MEASUREMENT PROGRESS

Measurement progress is displayed on the right of the Run Monitor screen. Sample
progress is displayed from sampling to the end of the reaction. The information is
displayed in columns and includes a sample type column, Sample Number (Sno.),
Method, Description and Error column.
Sample Type Column

Sample type is identified by the ‘Type’ column:
Normal or emergency sample
NONE Normal measurement (first measurement)
A> Sample re-run (greater than higher limit)
A< Sample re-run (lower than lower limit)
D1 Diluted re-run (first measurement)
Quality control sample

C1 First measurement
Standard/Calibrator
#1 First measurement
#2 Second measurement
#3 Third measurement

+44 (0) 28 9445 1070
Sample No. Column

Information in this column is based on the sample number type as described below.
Normal sample 0001-999999999999 (except 96000001 – 99999999)
Emergency sample Ennn (nnn = number, letter, or symbol)
Replicate sample Rnn (nnn = number, letter, or symbol)
QC sample C01-C30
Calibrator S000011 - S999997
Multi-Calibrator MS01 - MS97
Single calibrator SS000011 - SS999997
Blank Sample B
Method Column
Displays method name.
Patient ID Column
Displays Patient ID.
Result Column
Displays result when analysis is complete (excludes ISE and replicate samples).
Error Column
Indicates errors during the sample progress.
SS Insufficient volume of sample
SI1 Aspiration of sample disabled at ASP position
SI2 Aspiration of diluent disabled at IRU position
R1S Insufficient volume of primary reagent (R1)
R2S Insufficient volume of secondary reagent (R2)
DS Aspiration of diluent disabled at RCU position
WS Aspiration of wash solution disabled at RCU position
TE1 IRU temperature lower than 35 ºC
TE2 IRU temperature greater than 39 ºC
TE3 RCU temperature greater than 15 ºC
R1B R1 reagent bottle not registered

+44 (0) 28 9445 1070
R2B R2 reagent bottle not registered
DB Diluent bottle not registered
WB Wash solution bottle not registered
IE1 No response from ISE
IE2 No measurement result obtained from ISE
EST Error arises during measurement and sampling interrupted
R1W Wash of RPT between methods failed (timing of R1 reagent)
R2W Wash of RPT between methods failed (timing of R2 reagent)
LOT Erroneous Lot number of R1 and R2
EXP Reagent expired
STB Reagent on-board stability exceeded
CTO Calibration interval exceeded
CA?
CAL
LIN
These flags are not displayed on the run monitor screen
PRO but are printed on results page. (Refer to Section 5.4 for
description.)
AB1
AB2
DUP
SEN
3. 3. 2 FINISH ANALYSIS
When analysis is complete, the system will perform a brief ROUND termination during
which time the user cannot enter patient information, print data or save details.
3. 3. 3 SYSTEM ALARMS
The ALARM key on the main menu will flash RED when errors occur during analysis.
1. Click on ALARM(F4) to determine the source of the error.
2. Double click on the error field for further details.

+44 (0) 28 9445 1070
3. 3. 4 ANALYSER SHUT DOWN

1. Select SHUTDOWN.
When Shutdown is selected, the following options will be displayed.
It is recommended that SLEEP is selected when the analyser is not in use. During
SLEEP mode the reagent cooling and ISE priming is maintained. This allows the user
to use the AUTOSTART function at specified times.
2. Click on SLEEP and the following options will be displayed.
Cuvette Water Placement - the user can select either SYSTEM WATER or WASH
SOLUTION for cuvette displacement or alternatively click on the DISABLE option to
deactivate this option.
SPT Nozzle Wash - select ENABLE to activate or DISABLE to deactivate this option.
RPT Nozzle Wash - select ENABLE to activate or DISABLE to deactivate this option.
ISE Cleaning - select ENABLE to activate or DISABLE to deactivate this option.

+44 (0) 28 9445 1070
The sequence of events for SLEEP is as follows:

(1) System initialization.
(2) Water displacement of all 45 cuvettes in the IRU.
(4) WU1 and WU3 lines are rinsed with system water.
(5) ISE unit cleaning.

+44 (0) 28 9445 1070
(7) Nozzle wash.
(9) System water is placed into all 45 cuvettes in the IRU.
(10) System to sleep mode.
3. Sleep Mode Confirmation.

The MAINTENANCE/AUTO START (F12) screen will be displayed on screen and
“SLEEP” mode is established.

+44 (0) 28 9445 1070
Figure 3.40 Automatic Startup Screen (Sleep Cancel Window)
To manually cancel sleep mode select ‘SLEEP CANCEL’ and the analyser will return
to Standby.
3. 3. 5 RESTART ANALYSIS
The analyser will automatically restart at the time set in the Maintenance/Autostart
(F12) screen. The analyser can be started manually by clicking on the SLEEP
CANCEL button when sleep mode is selected.
POWER OFF should only be used when the instrument is being serviced or if the
instrument will not be in use for an extended period of time.
WARNING: If POWER OFF is selected the reagents will not be cooled and the
ISEs may dry out and become unusable.

+44 (0) 28 9445 1070

+44 (0) 28 9445 1070
SECTION 4 ACCESSORY FUNCTIONS Version 2.0 Rev September 2009
SECTION 4
ACCESSORY FUNCTIONS
This section describes the accessory features, settings and functions that can be
used on the RX daytona analyser.

+44 (0) 28 9445 1070
4.1 INTERRUPTION OF MEASUREMENT

During routine operation analysis may be manually interrupted and resumed.
4. 1. 1 EMERGENCY STOP
An emergency stop may be initiated if there is a severe analyser malfunction. When
an emergency stop is initiated, un-processed data will NOT be retrievable.
Press CONTROL and STOP (F2) to initiate an emergency stop.
The STATUS field in the RUN MONITOR screen will display the following message:
‘EMERGENCY STOP IN PROGRESS’.
In some circumstances the system will automatically initiate an emergency stop. After
the emergency stop has been initiated the analyser will perform system initialisation
and a cuvette wash to clean the cuvettes used during measurement.
4. 1. 2 INTERRUPTION OF SAMPLING
Sampling may be interrupted to add more samples or load emergency samples.
4. 1. 2. 1 SAMPLE INTERRUPTION TO LOAD EMERGENCY SAMPLES

This enables the user to load emergency samples into the sample carousel during
analysis. When this mode of interruption is utilised the analyser will stop analysis
immediately and perform analysis of the emergency samples before resuming routine
sampling. Normal samples may be added using this option if they require priority of
analysis (non-barcode mode).
The procedure for adding emergency samples is slightly different if the sample
barcode reader is enabled or disabled. This is defined in the SYSTEM
PARAMETERS/ SYSTEM (F9) screen.

+44 (0) 28 9445 1070
4. 1. 2. 1. 1 EMERGENCY SAMPLE ADDITION (BARCODE DISABLED)

1. Press STAT/NORM (F3) on the main menu.
If the system is currently sampling, a pop up window will appear asking the user to
identify the sample type (EMERGENCY or NORMAL).
2. Select ‘EMERGENCY’.
‘PLEASE WAIT PREPARING FOR INTERRUPTION’
The analyser will continue processing the current sample.
A pop up screen will appear indicating where to place the sample.
(1) RERUN CONDITION IS SET TO ‘NO RERUNS’
(2) RERUN CONDITION IS SET TO ‘ENABLE RERUN’.
PLEASE NOTE: The Emergency Sample(s) should be placed in a vacant

position if possible to minimise impact on other samples. The Emergency
sample(s) will be processed faster if placed after the 3 prohibited positions.

+44 (0) 28 9445 1070
3. Remove the ASP lid and place the sample tubes in the carousel.
4. Replace the carousel lid and select OK
5. The software will automatically go to the RUN MONITOR/TEST SELECT (F10)
screen. Select sample type ‘E’ and select the tests required for each sample in the
appropriate sample position. Patient demographic information may be entered if
required.
6. Click SAVE.
7. Press START (F1) or STAT/NORM (F3). The analyser will move the emergency
sample(s) to the sampling position and measurement will take priority over the
normal samples. Analysis of normal samples will continue after the emergency
sample(s) has completed sampling. The status field in the top left corner of the
screen will display STAT in red during analysis of the emergency sample.
4. 1. 2. 1. 2 EMERGENCY SAMPLE ADDITION (BARCODE ENABLED)

2. Select TEST SELECT.
3. Click on Page 1 of 2 for a NORMAL sample or page 2 of 2 for an EMERGENCY
sample.
4. Enter emergency barcode number and select the tests required for each sample
(as described in the test selection section of this manual). Repeat for each
emergency sample.
identify the sample type (EMERGENCY or NORMAL).
‘PLEASE WAIT PREPARING FOR INTERRUPTION’.
A further message will appear stating:
‘SAMPLING INTERRUPTED’
This window will indicate where to place the sample tubes.

+44 (0) 28 9445 1070
7. Lift the lid of the ASP and place the sample tubes in the carousel. Replace the
ASP lid.
8. Click on START (F1).
The analyser will move the emergency sample(s) to the sampling position and
measurement will take priority over normal samples. Routine analysis of normal
samples will continue after emergency sample(s) has completed sampling.
The status field in the top left of the screen will display STAT in RED whilst
processing the emergency sample.
When the emergency sample(s) has been sampled, the probe will continue sampling
normal samples restarting at the interrupted position number.

+44 (0) 28 9445 1070
Figure 4.1 Emergency Sample Test Selection Screen
4. 1. 2. 2 SAMPLE INTERRUPTION TO LOAD NORMAL SAMPLES

When a normal sample is to be added, click STAT/NORM (F3) and select NORMAL
in the pop-up window.
Normal sample addition (barcode disabled)

1. Select STAT/NORM (F3).
identify the sample type (Emergency or Normal).
‘PLEASE WAIT PREPARING FOR INTERRUPTION’
The analyser will continue processing the current sample.

+44 (0) 28 9445 1070
A further message will appear indicating vacant sample positions.

PLEASE NOTE: The sample(s) should be placed in a vacant position to

minimise impact on other samples. The sample(s) will be processed faster if
placed after the 3 prohibited positions.
3. Remove the ASP lid and place the sample tubes in the carousel.
4. Replace the ASP lid and select OK.
The software will automatically go to the RUN MONITOR/ TEST SELECT (F10)
screen.
5. Select sample type ‘N’ and select the tests required for each sample in the
sample position. Patient demographic information may be entered if required.
6. Click SAVE.
7. Press START (F1) or STAT/NORM (F3). The analyser will move the sample(s) to
the sampling position and measurement will take priority over normal samples.
Routine analysis of normal samples will continue automatically. The status field
will display STAT in a red box whilst processing emergency sample(s).

+44 (0) 28 9445 1070
Normal sample addition (barcode enabled)

2. Select the test selection screen page 1/2 for a NORMAL sample.
3. Enter barcode number and select the tests required for each sample (as described
in the test selection section of this manual). Repeat for each sample.
identify the sample type (Emergency or Normal).
5. Select ‘NORMAL’.
‘PLEASE WAIT PREPARING FOR INTERRUPTION’.
A further message will appear stating:
‘SAMPLING INTERRUPTED’ and will indicate vacant sample positions.

+44 (0) 28 9445 1070
6. Lift the lid of the ASP and place the sample tubes in the carousel. Replace the lid.
7. Click on START (F1).
The analyser will move the sample(s) to the sampling position and measurement will
take priority over normal samples. Routine analysis of normal samples will continue
automatically. When sampling is complete the probe will continue sampling restarting
at the interrupted position number.
PLEASE NOTE: Normal samples added using the STAT/NORM function are
processed as part of the run and are not treated preferentially.

+44 (0) 28 9445 1070
4.2 SAMPLE RE-RUNS

Identification of samples for automatic re-run is available in the software. Reruns can
be performed for samples that are either greater than, or less than, the defined
technical range. Re-run results are flagged with the letter ‘r’ on the SYSTEM PRM/
RESULTS screen and on the results printout.
4. 2. 1 AUTOMATIC RE-RUNS
The software can be programmed to automatically perform sample re-runs when the
results are outside the measuring range or exceed check limits e.g. Prozone.
To activate an automatic re-run follow the instructions below.
1. Select RUN MONITOR (F5)/CONDITION (F12).
2. Select ‘ENABLE RERUN’ in the ‘AUTOMATIC RERUN’ field.
4. 2. 2 RESULT OUTSIDE THE MEASURING RANGE

The re-run is performed according to ‘Rerun (high)’ and ‘Rerun (Low) settings in
Chemistry Prm/ Chemistry (F9) screen. The measurement is performed under the
same conditions as the initial measurement. A re-run is performed if the sample result
(concentration or absorbance) is outside the technical range specified below.
Figure 4.2 Re-run Settings for Out of Range Results
4. 2. 2. 1 SAMPLE RE-RUN WITHOUT DILUTION

When a sample result is outside the technical range a re-run may be required using a
smaller or greater sample volume. In this case the sample does not require dilution.
The rerun is performed using the RE-RUN/DILUTION settings in CHEMISTRY
PARAMETERS (F6).

+44 (0) 28 9445 1070
Minimum volume
sample + diluent = 120ul
Diluted sample volume at high re-run
Sample volume at low re-run Sample volume to be diluted
1. Select CHEMISTRY PARAMETERS (F6)/CHEMISTRY (F9).

The pre-defined settings used for sample re-runs will be displayed.
2. Click on the RE-RUN field to alter the sampling volume and enter the new volume.
3. Select RUN MONITOR (F5).
4. Click SAVE.
4. 2. 2. 2 SAMPLE RE-RUN WITH DILUTION

If the sample concentration is greater than the technical range it is possible to perform
a rerun with automatic sample dilution. The software will report the final result for the
dilution factor.
Rerun dilution conditions are predefined for Randox closed channel chemistries
however dilution conditions for open channel chemistries can be entered as follows:
2. Click on the METHOD field and press the SPACE bar to view the test menu.
3. Select the test option required. The screen will display the pre-defined settings.
(pre-defined settings are generally used for sample re-runs).
4. Click on the ENABLE option in the DILUENT field and then click on REAGENT
NAME. Press the SPACE bar to view the options.
5. Click on ENABLE In the DILUTION field.
6. Enter the volume of neat sample and the diluent volume in the fields below (a
minimum total volume (sample + diluent) of 120μl should be specified).
7. Enter the required sampling volume (diluted sample) In the RE-RUN field .
8. Click SAVE.
PLEASE NOTE: Automatic sample dilution conditions cannot be entered unless

a diluent is enabled and selected.

+44 (0) 28 9445 1070
4.3 CALIBRATION
This section describes the system calibration features. There are three calibration
options available:
S Single Calibrator - 2-point to 7-point calibration using 2 to 7 separate
calibrators.
SS Standard Series - Onboard serial dilution of a single calibrator to generate a
standard series.
MS Multi-Standards - Calibrator series for multiple tests.
4. 3. 1 STANDARDS
Two to seven calibrators are required for a single test.
4. 3. 2 STANDARD SERIES (SS)

A multi-point calibration can be performed by loading a single calibrator (of the
highest concentration in the calibrator series), from which the system can
automatically prepare a series of standards.
The software requires the DILUENT option to be enabled in the PARAMETER screen
as described below.
1. Select CHEMISTRY PRM(F6)/CHEMISTRY (F9).
2. Click on ENABLE in the DILUENT field.
3. Click on the reagent name field and press the SPACE bar to select the diluent.
4. Select the required diluent name (usually SALINE).
5. Place the bottle in the RCU.
6. Click SAVE to save changes.

7. Select RUN MONITOR (F5)/Select INVENTORY (F5).
8. Check that there is sufficient diluent.
To specify conditions of the serial dilution follow the procedure below.
9. Select CALIBRATION (F7)/CALIBRATION (F9).
10. Press the SPACE bar and double click on the required test.

+44 (0) 28 9445 1070
11. Click on PARAMETERS and enter the required concentration of each standard in
the series. The concentration of the highest standard loaded onto the sample
carousel is entered against the last standard position number in the series (if there
are 6 standards in the series the highest concentration should be entered in
position S6).
When entering concentrations please note that for auto dilution:
minimum volume of sample + diluent = 80μl

maximum pre-sampling volume = 35μl
Example: If the neat sample had a concentration of

30 mmol/l then the following standard concentrations would be prepared:
StandardConcentration Calculation
Standard solution 1: 0
Standard solution 2: 1.875 (0.0625 * 30)
Standard solution 6: 30 (1 * 30)
12. Select PAGE 2 of 2 to display the following screen.

+44 (0) 28 9445 1070
Figure 4.3 Calibration (2/2) Screen
13. Click on ENABLE in the SERIAL DILUTION field.

14. Confirm the ratio of pre-sampling to diluent displayed on screen.
15. Click on CALCULATION.
If invalid concentrations are entered in the PARAMETERS screen (PAGE 1 of 2) the
volumes will be displayed in RED. The concentrations must be altered using the
minimum and maximum volumes described above.
16. When all settings are entered, place the highest concentration calibrator in the
ASP and initiate calibration measurement.
17. Click SAVE.

+44 (0) 28 9445 1070
4. 3. 3 REGISTER MULTI-CALIBRATOR DETAILS (MS)

This option is used to register multiple tests to a single calibrator series. Ten multi-
standard sets can be specified with up to 7 calibrators per set.
Set No. Multi standard set Bar code

1 MS01 – MS07 95000001 – 95000007
2 MS11 – MS17 95000011 – 95000017
3 MS21 – MS27 95000021 – 95000027
4 MS31 – MS37 95000031 – 95000037
5 MS41 – MS47 95000041 – 95000047
6 MS51 – MS57 95000051 – 95000057
7 MS61 – MS67 95000061 – 95000067
8 MS71 – MS77 95000071 – 95000077
9 MS81 – MS87 95000081 – 95000087
10 MS91 – MS97 95000091 – 95000097
1. Select CALIBRATION (F7)/MULTI (F11).

2. Select the multi-standard set (calibrator) identification numbers using the drop-
down menu in the ‘MULTI-STANDARD SET’ field.
3. Move the cursor to the required test and click on the box to select the test. A tick
will appear on selection. Repeat this process for tests required for the
multi-calibrator set selected. Tests can be deselected by clicking on the tick box.
4. Click SAVE to save the selection.
Figure 4.4 Multi-standard Selection

+44 (0) 28 9445 1070
Figure 4.5 Multi-Calibrator Screen
Figure 4.3 shows that the set 01 is allocated to IgG, IgE, and CRP (assuming that the
same calibrator set is required for a full calibration of the methods ticked above).
attach MS01 bar code label (95000001) to Std-1;

attach MS04 bar code label (95000004) to Std-4; and
attach MS05 bar code label (95000005) to Std-5.
This defines a multi-standard set. It is possible to edit the selection for the next run
using the mask function on the RUN MONITOR/TEST SELECT (F10) screen as
described in Section 3. 2. 4. 4 Masking Option (Barcoded and Non Barcoded
Samples)” on page 81. All tests selected will be calibrated each time this multi-set is
run. Use the Masking function to de-select tests.

+44 (0) 28 9445 1070
4.4 OPERATIONAL CONDITIONS AND PARAMETERS

This section provides information on changing operational conditions and parameters
for each functional item.
Item Name Function

Chemistry Parameters Chemistry Parameters for Randox closed
Page 1/2 channel assays are pre-defined and mostly
non-editable. Open channel assays allow the
user full access to define parameters used.
Serum Information Entry of various parameters for the
Page 2/2 measurements of turbidity (L), haemolysis (H)
and icterus (I) in serum samples.
Calculate (F10) Equations are defined for calculated tests.
Profile Test profiles can be specified to enable
multiple methods to be selected at one time.
Order of measurements The measuring order and printing order are
and printout specified.
System parameters Specification of serial communications with
host computer, date, time and specification of
bar code type.
Registration of reagents Each bottle code and bottle size (large,
medium or small) of reagents, wash solutions
and diluents placed in the RCU are specified.
Patient information Patient details may be entered.
Replicate sample Number of replicates specified for replicate
samples.
Back up disc (FD) Back up and loading of analyser settings.
operation
ISE parameters The bottle code for ISE urine diluent is
specified.
Last ISE calibration and ISE instrument
factors.

+44 (0) 28 9445 1070
4. 4. 1 ANALYTICAL CONDITIONS (CHEMISTRY PARAMETERS) PAGE 1 OF 2

Conditions for analysis of patient samples are generally pre-defined and do not need
alteration. The software provides the option to alter the analytical conditions for open
channel chemistries. For closed channel chemistries the operator can only alter the
settings for Normal Range, Number of decimal Points, Instrument Factors, Technical
Range fields and Units. All other fields in the Chemistry Parameters screen will be
deactivated for closed channel chemistries.
The screen will display the chemistry parameters.
2. Move the cursor to the required field and enter as required. The TAB key may be
used to scroll through the list.
3. Click SAVE to save the settings.
Figure 4.6 Chemistry Parameters Screen
Method (Method number)

Press the SPACE bar to view the pop-up window, the available assay methods are
displayed.
1. Select a method number.
2. Press return to confirm the selection.
3. Select any unused number for a new open channel

+44 (0) 28 9445 1070
Name (Method name)

Enter the name of the new test. A method name can be entered in the form of letters,
numbers, symbols or a combination, up to 6 characters. When the method number is
selected, the corresponding name is displayed in the ’Name’ box.
Unit
Enter the unit required for result reporting. (Up to 6 characters may be entered.)
Assay Type
There are two assay types, i.e. Rate method and End method. Select the required
type by clicking on the scroll arrow of the ’Assay Type’ box.
Measuring Points (End)

The software offers the facility to specify the photometric measuring points for
analysis. Options facilitate single or two point assays by using measuring range-1 and
2 options.

+44 (0) 28 9445 1070
The analyser uses an average number of absorbance measurements over a specified

range, rather than a single measurement. Details of the measurement intervals are
listed below.
RX DAYTONA TIME READING INTERVALS

Action Time after sample addition Time after R2 addition
R1 Addition -0:20
Sample addition 0:00
Mix 1 0:20
Read 1 0:40
Read 2 1:00
Read 3 1:20
Read 4 1:40
Read 5 2:00
Read 6 2:20
Read 7 2:40
Read 8 3:00
Read 9 3:20
Read 10 3:40
Read 11 4:00
Read 12 4:20
Read 13 4:40
R2 Addition 5:00 0:00
Mix 2 5:20 0:20
Read 14 5:40 0:40
Read 15 6:00 1:00
Read 16 6:20 1:20
Read 17 6:40 1:40
Read 18 7:00 2:00
Read 19 7:20 2:20
Read 20 7:40 2:40
Read 21 8:00 3:00

+44 (0) 28 9445 1070
Read 22 8:20 3:20
Read 23 8:40 3:40
Read 24 9:00 4:00
Read 25 9:20 4:20
Read 26 9:40 4:40
For single point endpoint assays and single rate assays measurement range 1 is not
required and should be disabled by clicking on the DISABLE box. Both measurement
ranges are required for two-point and blanked end point and double rate assays.
Measuring points (refer to the read time intervals) are entered into the ‘START’ and
‘END’ boxes for each Measuring Range (where appropriate).
Measuring points of Measuring Range-1: 1 – 13 and Start < End,

Measuring points of Measuring Range-2: 14 – 26 and Start < End.
Endpoint Assays: 2 consecutive read points (e.g. 23 and 24) should be chosen and
the average absorbance of the points is used in the calculation.
Single Reagent Endpoint Assay: Measuring range-1 should be disabled, and 2

consecutive read points chosen.
Two Reagent Endpoint Assay: Consecutive read points prior to R2 addition should
be entered for Measuring range-1. Then 2 consecutive read points several minutes
after addition of R2 should be entered for Measuring range-2. Results are calculated
by subtracting the average of the read points before R2 addition i.e. Measuring
range-1 from the average of the read points from Measuring range-2.

+44 (0) 28 9445 1070
2 Point or Fixed Time Assays: A delta absorbance between fixed time points is
measured. Both Measuring range –1 and –2 are used. The same read point is
entered for the START and END options of range-1 and range-2. The absorbance of
measuring range 1 is subtracted from measuring range 2.
Rate Assays: The START and END points for the kinetic measurement is entered in
measuring range-2. Measuring range-1 is disabled unless a blank rate measurement
is required. The average delta absorbance per minute is calculated by using linear
regression through the read points in the measuring range.
Wave Length (Wavelength of Optical Filter)

The measurements can be performed using two wavelengths as a main and
secondary-wavelength. The primary wavelength is selected by clicking on the arrow
key of the wavelength selection box. A secondary-wavelength is selected in the same
way as the primary-wavelength. If the secondary wavelength is not required, click on
the DISABLE box.
Sampling Volume
The sampling volume entered in µl.
A sample dilution facility is available by clicking on ENABLE to select and DISABLE

to deselect. The ENABLE button will only be activated if the DILUENT is enabled on
the same screen.
Select ’DISABLE’ when sample dilution IS NOT required.

+44 (0) 28 9445 1070
Select ’ENABLE’ when sample dilution IS required.

Volumes of sample and diluent are entered in µl. The volume of diluted sample is
equal to the sampling volume.
Re-run (High)
A sample re-run dilution option is activated by clicking on ENABLE to select and
DISABLE to deselect.
Select ’ENABLE’ when sample dilution is required.
Select ’DISABLE’ when sample dilution is NOT required.
In this case, the volume of sample to be diluted and diluent volume are entered in µl.
The volume of diluted sample is equal to the rerun volume.
PLEASE NOTE: Minimum volume for sample + diluent is 120µl.
If the sample or re-run dilution facility is enabled, the diluent must be enabled,
registered and on board the analyser for the test to be selected on the test selection
screen.
R1 Reagent name
When the cursor is moved to ’R1 Reagent Name’, press the SPACE bar and a pop-up
window will display the bottle codes for available tests. Select the required reagent
name. The reagents that cannot be used are displayed with a grey background.
R1 volume
Select the appropriate field and enter the reagent volume in 5µl increments. Select a
volume range 20-400µl.
This screen also offers the option to use a second reagent.
Select ’ENABLE’ when R2 reagent is used.
Select ’DISABLE’ when R2 reagent is not used (Single reagent method).
R2 Reagent name and reagent volume can be entered when ’ENABLE’ is selected.

+44 (0) 28 9445 1070
Wash (Wash solution)

The wash solution is used to wash nozzles (RPT/SPT/Mix-1/Mix-2) and cuvettes
Select ’ENABLE’ when wash is performed.

Select ’DISABLE’ when wash is not performed.
The bottle code of the wash solution is selected from the pop up window which is
displayed when the SPACE bar is pressed. The wash solution must be registered in
the system parameters screen.
When ’ENABLE’ is selected, each nozzle is washed before measurement takes

place.
The system requires approximately 600µl per test for the wash procedure. Please
ensure that sufficient wash solution is onboard.
Wash Solution Procedure

1. Wash solution is initially aspirated by the RPT from the bottle and contained in the
reagent container (RCU).
2. The solution is then dispensed into cuvettes on the IRU.
3. The IRU rotates and the SPT nozzle descends into the cuvette filled with wash
solution.
4. The SPT nozzle aspirates and dispenses wash solution to wash the nozzle.
5. The IRU rotates up to the stirring position and both Mix-1 and Mix-2 are washed
by wash solution in the cuvette.
Diluent
Diluent is used to dilute samples and/or calibrators when required. The sample diluent
is specified when ‘ENABLE’ is activated and the bottle code is entered. The bottle
code of the diluent is selected from the pop up window, which appears when the
SPACE bar is pressed

+44 (0) 28 9445 1070
Extension
This option enables the user to define additional normal ranges. When the extension
button is clicked a pop up window will appear (see below).
Figure 4.7 Chemistry Parameters Screen
A lower and upper limit is defined for each normal range. The names (description) of
the normal ranges displayed are defined in the SYSTEM (F9)/SYSTEM
PARAMETERS screen. After setting the ranges, click OK to save the information.
When the extension normal ranges are used in the test selection (TEST SELECT
(F10)/RUN MONITOR (F5)) the judgement criteria is applied to the result.
Normal Range
Enter the normal range.
When the measured concentration is lower than the specified lower limit, the flag ‘L’ is
displayed beside the result.

+44 (0) 28 9445 1070
When the measured concentration is higher than the specified upper limit, the flag ‘H’
is displayed beside the result. The upper limit must be >0 and filled to obtain results
without an H flag.
Lower limit Upper Limit
Technical Range
The upper and lower limits of the valid technical range are defined by concentration
and absorbance.
Results outside the range are flagged with ‘<’ or ‘>’ symbols to indicate that the results
are lower or higher than the specified range.
RPT Wash (Washing of reagent pipette)

Pure water or wash solution is selected for reagent pipette washing (RPT).
Select ‘SYS. WATER’ when the RPT nozzle is washed with pure water.
Select ‘WASH SOL.-3’ when the RPT nozzle is washed with wash solution.
Bottle Volume
The bottle volumes are displayed according to the volumes specified in the SYSTEM
PRM/SYSTEM screen.

+44 (0) 28 9445 1070
Instrument Factor (Correlation correction factor)

The Instrument Factor is used to correct small variations in values between
commercially available systems.
The linear correction is applied to all results. Slope (a) and intercept (b) are entered. If
zero (0) is entered for slope (a), no correction of this instrument factor is applied.
Stirring Speed
Enter the stirring speeds of Mix-1 and Mix-2.
Decimal Point
Select the number of decimal points required for reporting results.
Save
Press SAVE to save the method parameters or CANCEL to restore previous data.

+44 (0) 28 9445 1070
4. 4. 2 SERUM INDICES
The Serum Indices function determines the level of Lipaemia, Haemolysis and Icterus
in patient samples therefore eliminating the need for visual inspection.
To enable the Serum Indices function:

1. Select RUN MONITOR (F5)/CONDITION (F12)
2. Click ENABLE in the Serum Information field.
To view Serum Indices Information:

1. Select Chemistry PRM (F6)/CHEMISTRY (F9)
2. Select page 2 of 2
Figure 4.8 Serum Information Screen
The absorbance readings for the Icterus index are taken in the following ranges:
415-510nm
570-600nm
600-700nm.
The Icterus absorbance is corrected for Haemoglobin and Lipaemia.
Factors A-F are fixed factors that are obtained experimentally and used in the above
equations to calculate the serum index.
Method: 81 (fixed number)
Name: SI (fixed)
Sampling Volume: Sampling volume of sample (µl)

+44 (0) 28 9445 1070
R1 Reagent Name: Specify the reagent which must be registered. (Saline is

specified in the above table)
Volume: Sampling volume of R1 reagent (µl)
Factor A to F (0 – 999999)
When the serum information function is enabled in the CONDITION/RUN MONITOR

screen, the RX Daytona will automatically inspect the condition of each sample and
provide a numerical value that corresponds to the concentration of Haemolysis (H),
Lipaemia (L) and Icterus (I).
Method of Measurement
The Lipaemia, Haemolysis and Icterus levels are calculated using the following
equations:
= λ600, =λ700, = λ570, = λ415, = λ510

λxxx represents the absorbance values of each wavelength λrxxx which are obtained
from measurements of sample and phosphoric acid buffer and corrected by water
blank λwxxx. For example, in the case of wavelength of 600 nm,
λ600 = λ r600 - λ w600.

+44 (0) 28 9445 1070
A bsorbance T urbidity
NADH Icterus H em olysis
L = Turbidity Index
C = Scaling factor for Lipaemia.
H = Haemolysis Index
A = Scaling factor for Haemoglobin
B = Corrects Haemoglobin measurement for Lipaemia.
I = Icterus index
D = Scaling factor for Bilirubin
E = Corrects Bilirubin measurement for Haemoglobin
B = Corrects haemoglobin measurement for Lipaemia
F = Corrects Bilirubin measurement for Lipaemia.
A Saline or Phosphate buffer may be used to measure the serum index

spectrophotometrically.
16µl of sample are added to 180µl of Saline. The system monitors the absorbance at
the following pairs of Bichromatic wavelengths:
415nm and 510nm
570nm and 600nm
600nm and 700nm
These absorbance figures are used to calculate the serum index.
Lipaemic (L) = 1/(C/10) x (Abs600nm - Abs700nm)
The absorbance readings for the lipaemic index are taken within the 600-700nm
range.
Haemolysis (H) = 1/(A/10) x (Abs570nm – Abs600nm) – ((B/105)(Abs600nm -

Abs700nm))

+44 (0) 28 9445 1070
The absorbance readings for the haemolysis index are taken in the 570-600nm and
600-700nm range. The haemolysis absorbance is corrected for Lipaemia.
Icterus (I) = 1/(D/10) x (Abs415nm – Abs510nm) - ((E/105)(Abs570nm –

Abs600nm)) – ((F/105)(Abs600nm - Abs700nm))
Haemolysis Range (example)
HO for haemolysis <250

H1 for haemolysis 251 to 500
H4 for haemolysis >1000
Turbidity Range (example)
LO for Turbidity <250

L1 for Turbidity 251 to 500
L4 for Turbidity >1000

+44 (0) 28 9445 1070
Icterus Range (example)
LO for Icterus <8

L1 for Icterus 8 to 15
L4 for Icterus >30
The serum index results will be printed along side the assay results when analysed.
The assay actual patient result will not be re-run or adjusted by running serum
indexes, however the index will give a numerical value:
H0-H4 for Haemolysis, where H0 = <250mg/dl, H4 = >1000mg/dl;

I0-I4 for Icterus where I0 = <7.5mg/dl, I4 = >30mg/dl
L0-L4 for Lipaemia where L0 = <250mg/dl, L4 = >1000mg/dl.
The operator who validates the patient results can then decide, based on the index
value reported, if the particular chemistry being analysed is affected.
PLEASE NOTE: When the ENABLE button on the RUN MONITOR/ CONDITION
screen is activated and the factors defined, a serum indices measurement will
be performed on every sample.

+44 (0) 28 9445 1070
When a result is printed, the ISE and normal sample result is printed along with the
serum information (see figure 4.9 below) .
Sno. : 101 ID :2001082701 D ate : 20020827 R oundN o : 006

U R EA AST
15.1 20.5
SI H3 ( 358) L+- ( 32) I-- ( 68)
M ethod N am e R esult of H em olysis R esult of Turbidity Result of Icterus
4. 4. 3 METHOD TO METHOD CALCULATION

The software provides the facility to report a calculated value of test result(s) using a
defined equation. Total Cholesterol (TC) and HDL cholesterol values may be
requested as a ratio of TC/HDL. The software can be programmed to perform the
calculation automatically.
The software uses test method numbers 1 to 60 to identify individual test parameters.
Test method numbers 71 to 80 are assigned for calculation values.
1. Select CHEMISTRY PRM (F6)/CALCULATE (F10).
2. Move cursor to the METHOD field and press the SPACE bar to view methods
71-80.
3. Click on the required method.
4. Move cursor to the NAME field and enter the required information.
5. Enter the units and the number of decimal places.
6. Enter the calculation in the EXPRESSION field. The calculation equation can be
specified using symbols of four fundamental operations (+, –, x, / ) and brackets.
The method number may be selected by clicking on the required method in the list
or typed directly into the field.
7. The normal range values are entered in the appropriate field.

+44 (0) 28 9445 1070
Figure 4.9 Method to Method Calculation Screen
If results are available for all methods specified in the EXPRESSION field the
software automatically calculates the expression and presents the values.
4. 4. 4 TEST PROFILE
Test Profile enables the user to define a profile of tests that are performed on a
regular basis. This profile is then selected during the test selection process, rather
than repetitive selection of a number of individual tests.
1. Select CHEMISTRY PRM (F6)/PROFILE (F11).
2. Move cursor to the METHOD field and press SPACE bar. Profiles 1 –8 will be
presented. Double click on the required profile number.
3. Enter the profile name in the NAME field.
4. Click on the required boxes in the SELECTED METHOD field to select tests.
5. Click SAVE to store the information.

+44 (0) 28 9445 1070
Figure 4.10 Test Profile Screen
A tick mark represents the tests selected for the profile. To deselect the test,
click on the field.
4. 4. 5 TESTING ORDER AND RESULT PRINTOUT ORDER

This facility enables the user to select the order of test measurement and then specify
the order in which results are printed.
4. 4. 5. 1 TESTING ORDER
1. Select CHEMISTRY PRM (F6)/ORDER (F12).
2. Select Page 1 of 2 on screen display. Testing order of registered methods can be
defined by clicking on the method number in the list of methods (right side of
screen) and dragging it to the measuring order list (left side of screen). Methods
and wash solutions may be specified. ISE’s cannot be selected.
3. Click on SAVE to store the information.

+44 (0) 28 9445 1070
Figure 4.11 Testing Order Screen
TESTING ORDER LIST
If particular assays are found to interfere with each other it may be necessary to
change the order the tests are performed. If this is the case one assay could be
assigned a low test number and the other a high number ensuring that these assays
are separated by other assays in a test profile.
4. 4. 5. 2 RESULT PRINTOUT ORDER

Result Printout order is defined in the same way as the testing order. Page 2 of 2
should be selected and the same procedure used as for testing order.
Figure 4.12 Result Printout Order Screen

+44 (0) 28 9445 1070
4. 4. 6 ENTRY OF SYSTEM PARAMETERS

Entry of system parameters field enables the user to define the system parameters,
registration of open channel reagents, operation of floppy disk, and retrieval of
results.
1. Select SYSTEM PRM (F6)/SYSTEM (F9).
The system parameters are displayed on screen.
2. Move the cursor to the required field and use the scroll arrow to view the list for
selection.
Figure 4.13 System Parameters Screen
Host Communication
The Host communication conditions are defined as follows:
Item Description Remarks
Baud Selection of baud rate: 19200/9600/ Default: 9600 bps
Rate 4800 bps
Data Bit Data bit length: 7/8 bits Default: 8 bits
Stop Bit Stop bit length: 1/2 bits Default: 2 bits
Parity Bit Parity bit: None/Even/Odd Default: None

+44 (0) 28 9445 1070
Details
This is an optional setting button for setting the output of data to either Host
Communications, Floppy Disc or Printout.
Click DETAILS and the following screen will appear:
Figure 4.14 Details Menu Options (Optional settings for data output)
The Details menu options are as follows:
HOST COMMUNICATIONS
Add Re-run Flag:
Tick box - Re-run flag included with data transferred to host computer
No tick - Re-run is performed, No re-run flag included with data.
Send Calc Test

Tick box Calculated test result output to host computer
No Tick Calculated test result not output to host computer
Send QC Result
Tick box QC result output to host computer
No Tick QC result not ouput to host computer
Add QC Flag
Tick box Judgement flags attached to QC data output to host computer
No Tick Judgement flags not attached to QC data output to host computer

+44 (0) 28 9445 1070
Patient Name
Tick box Patient name presented as Last Name, First Name, Middle Name.
No tick Patient name presented as Last Name, Middle Name, First Name.
Full compliance with ASTM rules

Tick box Online communication compatible with ASTM rules.
No tick Online communication is not fully compatible with ASTM rules. Please
refer to the Host Interface Software Specification document for further details. This
information is available from your local Randox representative.
Individual ISE order from host

Tick box Testing order of ISE is on individual test basis e.g. No 61-Na, No 62-K,
No. 63-Cl, No64-Na (Diluted), No. 65-K (Diluted), No. 66-Cl (diluted).
No tick Testing order of ISE is in standard form e.g. No 61-Na, K, Cl,
No 62-Na, K, Cl (Diluted).
Send error result

Tick box Send error flag results to host
No tick Do not send error flag results to host.
Patient Name length12/18

Set patient name length as either 12 or 18
FD Output
Tick to attach the judgement condition flag to the QC results when transferred to
Floppy Disc.
Untick to detach flag from QC results transferred to floppy disc.
Print Output
Tick to print the QC report in real time and untick to disable this function. The QC data
printout is available after measurement.

+44 (0) 28 9445 1070
Miscellaneous Settings (Extend from Min & Max calibration)

Tick box Min or Max point of calibration curve applied to result as a
concentration value.
No tick Measurement result is calculated from an extended calibration curve
as a concentration value.
Date
Enter the day. month and year for initial settings of system date.
Time
Enter initial time settings for the analyser.
Sample Barcode
Definition of sample barcode. Ensure that ENABLE is ticked for the sample barcode
(if required).
The sample barcode label type is defined as follows.

Type Options for selection Default setting
UPC(JAN) OFF OFF
With check digit
NW7 OFF With check digit
With check digit
Without check digit
Code39 OFF OFF
With check digit
Without check digit
ITF OFF OFF
With check digit
Without check digit
Code128 With check digit With check digit
Alarm Volume
An audible alarm is available on request. The audible alarm volume is set by clicking
on the drop down box and selecting a setting from OFF to 9.

+44 (0) 28 9445 1070
Alarm Setting
Click on the ALARM SETTING button to view the alarm options. One or more options
may be selected from the alarms detailed below:
Alarm 1 Emergency Stop has been initiated
Alarm 2 Sampling Stop has been initiated
Alarm 3 Warning has been activated
Alarm 4 Error has occurred in the PC
Alarm 5 Error has occurred when ASP rotation is completed.
Click on the required alarm and a tick will appear in the box. Click again to de-activate
the alarm.
Printout Header
There are 2 printout headers for hard copy reports:
• Universal Header – applied to all printed material. Click on the ‘PRINTOUT
HEADER’ field and enter the required header information.
• Definitive Header – defines specific headers for patient reports only. Click on the
‘DEFINE HEADER’ box and enter information.
Sample Number Increment

Click on ‘Sample Number Increment’ to define the method of sample number
increment. The following choices are available:
Numeric only Addition of 2 digits e.g. 01-99
Alphanumeric (Upper case) Addition of 2 digits e.g. 01-09, 0A-0Z, 10-99, 9A-ZZ
Alphanumeric (lower case) Addition of 2 digits e.g. 01-09, 0A-0Z, 10-99, 9A-ZZ,
Za-zz.
Program Version
Displays the program version currently in use.

+44 (0) 28 9445 1070
Reagent Code
List of all registered reagent codes. Closed channel reagent codes are pre-loaded
onto the software during installation and cannot be changed. This facility is used to
enter new method codes for open channel reagents, which can be registered,
changed or deleted.
Figure 4.15 Reagent Code List
The following window is displayed by clicking on the ADD or EDIT button. Click OK to
save the added or edited details.
Figure 4.16 Entering Reagent Details
Before registering a reagent, an open channel code (OA – OZ) and a reagent name
must be entered. Enter reagent details including type (R1, R2, WASH and Dil),
volume in bottle and size of bottle. An option is available to apply an on-board stability

+44 (0) 28 9445 1070
period to the reagent. Reagents that exceed this period will be flagged in the Run
Monitor/Inventory screen as follows:
YELLOW Reagent stability exceeded
PURPLE Reagent expired
RED Reagent bottle empty
If the reagent is a diluent or wash solution then the relevant option should be chosen.
Press OK to confirm reagent details and click SAVE (on the System Parameters/
System (F9) Screen) to store reagent details.
Full details of registration of open channel reagents are described in Section 3. 2. 2. 2

Registration of Open Channel Barcoded Bottles” on page 59.
4. 4. 7 DATA BACKUP
Data Backup enables the user to backup all data (results and settings) to the hard
disk or back up mechanical values and user parameters to floppy disc.
1. Select SYSTEM PRM/Backup (F10).
Figure 4.17 Backup Operation Screen

+44 (0) 28 9445 1070
Save Mechanical Values to FD

Insert a floppy disk into the FD drive of PC and click SAVE adjacent to the SAVE
MECHANICAL VALUES TO FD field.
Save User Parameters to FD

Insert a floppy disk into the FD drive of PC and click SAVE adjacent to SAVE USER
PARAMETERS TO FD field.
A list of parameter files (on FD) are displayed in the table below.
File name Description
FD1Version.txt Version number of database
FD2Version.txt Version number of database
Analysis.DB Methods
AnalysisISE.db ISE Methods
AnalysisISE2.db ISE Methods 2
AnalysisSI.db SI Method
AnalysisSI2.db Sl Method 2
AndCalc.db Calculated test information
Assaycon.db Chemistry parameters

+44 (0) 28 9445 1070
AttendingList.db Attendant list for patient information

AutoStart.db Time of activation of analyser
AutoStartPrep.db Setting status of Auto Start Prep
CalcItem.db Calculated test item
CalibCheck.db Calibration check
CalibRBSet.db Reagent blank settings for calibration
CalibSet.db Settings of calibration
CalibSng.db -----
CtrlList.db QC settings
CtrlName.db QC names
ExNormalRange.db Extension of normal range data
ExRangeName.db Name of normal range extension
LocationList.db Location list of patient information
Mainte.db Maintenance settings
MultiStd.db Settings of Multi-standard
OrderingList.db Ordering list of patient information
PhlebotomistList.db -----
PrintJunjo.db Printing order
Profile.db Profile conditions
Race.db Race for patient information
RcuRegntRx.db Reagent bottle information of RCU
ReagentBlank.db Reagent blank
ReferralList.db -----
SampleJunjo.db Sampling conditions
SiyakuBottle.db Reagent bottle related information
SiyakuName.db Reagent names
SiyakuType.db Reagent type related information
System.db System parameters
WashProgram.db Settings of Wash program

+44 (0) 28 9445 1070
Load Parameters
Insert floppy disc containing parameter information into the FD drive of the PC and
click LOAD.
Format FD
Insert floppy disc into the FD drive of the PC and click FORMAT.
System Parameters (Former generation)

Download system parameters that have been previously saved to floppy disc from an
earlier software version.
Insert the disc and click LOAD adjacent to the LOAD PARAMETERS field.
Data Backup
Back-up all data to a separate folder on the PC hard disk. Use this option when
upgrading software to prevent loss of results data.
Save data
Saves data. The progress is indicated by the bar chart and may take several minutes
depending on the quantity of data stored in the software.
Load data
Restores previously saved data.

+44 (0) 28 9445 1070
4. 4. 8 TEST SELECTION WHEN CONNECTED TO HOST COMPUTER

The software provides the option to download test method selections for individual
patient samples directly from a host computer system. Patient Demographic
information for each sample may be transferred to the analyser PC if required.
Data download is carried out in on-line batch or on-line real time mode.
1. Online Batch Mode 1 – the analyser is connected to the host and sample
information is ordered in batches. The results are automatically sent to the host
computer.
2. Online Batch Mode 2 - the analyser is connected to the host and sample
information is ordered in batches. The results are NOT automatically sent to the
host computer. The software requires user validation of results and transfer of the
data to the host computer.
3. Online Real Time Mode (Host Query Mode) – the analyser is in constant
communication with the host computer. Sample information is requested for each
sample when the analyser reads the barcode. Results are automatically
transferred back to the host computer as and when they become available.
4. 4. 8. 1 TEST SELECTION FOR SAMPLE IN ON-LINE BATCH MODE 1 AND 2

Using on-line batch mode 1 or 2, test selection information for all samples is
transferred to the analyser PC before measurement is initiated.
1. Check on the System Parameters/System (F9) screen and ensure the ‘SAMPLE
BARCODE’ mode is set to ‘ENABLE’.
3. Move the cursor to the required function within the HOST COMMUNICATION
MODE box.
4. Click on ON LINE BATCH 1 or 2. A pop up screen will appear asking the user to
restart the computer.
5. After re-starting the computer the analyser software will now be in batch mode and
ready for information transfer.
6. Load barcoded samples onto the sample carousel.
7. Go to (Run Monitor/Test Select (F10) screen and click on ‘ONLINE ORDER’.
8. Click on ‘ACQUIRE ORDERS’. The screen will display the message ‘RECEIVING
ORDERS’.

+44 (0) 28 9445 1070
The test selection for samples is transmitted from the host computer to the
analyser PC.
9. After the method codes for the test selection are registered and reagents and
samples are loaded, initiate measurement by pressing F1 START. Routine checks
and procedures are identical to an analyser operating in ‘OFFLINE’ mode.
The results are stored in the analyser PC and transferred to the host computer
(automatically in Batch 1 mode). See Section 5.2 RETRIEVAL OF STORED
RESULTS” on page 167 for transfer of results from analyser to Host PC.
Figure 4.18 Test Selection for Online Sample
4. 4. 8. 2 CONFIRMATION OF TEST SELECTION

The information sent from the host computer can be confirmed on screen prior to
measurement.
1. Select ‘LIST’ to display all requested tests for each sample.Selected tests are
displayed in blue and non-selected tests displayed in black. Tests not available for
2. To select/deselect a test, move the cursor to the relevant test and press the
SPACE bar.
3. Use the JUMP option to quickly find the defined sample number in a large list.
4. Click CLOSE to save any changes.

+44 (0) 28 9445 1070
4. 4. 8. 3 TEST SELECTION FOR SAMPLE IN ON-LINE REAL TIME MODE

The on-line real time mode function generates method codes for samples by sending
a query to the host computer when the sample barcode is read.
2. Select the required function from the HOST COMMUNICATION MODE box.
3. Click ON REAL TIME. The measurement is initiated after the method codes are
registered and reagents and samples are loaded.
The analyser reads the sample barcode and raises a query for the method codes
to the host computer, and then initiates measurement. This sequence is repeated
for each sample.
The measurement results are stored in the analyser PC and transferred to the
host computer in real time.
4. 4. 8. 4 CAUTIONS IN USING ON-LINE REAL TIME MODE

Test selection(s) transferred to the analyser PC from a host computer in on-line real
time mode cannot be viewed in the analyser software.
Test selection can be made in the analyser software for emergency samples only.
4. 4. 8. 5 SWITCH OFF HOST COMMUNICATION MODE

The Host Communication Mode may be switched off when not required.
2. Select the required function within the HOST COMMUNICATION MODE box and
click OFF LINE.
4. 4. 9 ENTERING PATIENT INFORMATION DETAILS

Each sample may be assigned a unique Patient ID number (Up to 13 alphanumeric
characters) that associates the sample with patient information. Patient ID numbers
may either be predefined or entered at the time of test selection.

+44 (0) 28 9445 1070
4. 4. 9. 1 ENTERING PATIENT ID NUMBER

Predefined Patient ID numbers are set up as follows:
1. Select SYSTEM PARAMETERS.
2. Select SYSTEM (F9).
3. Click on the page number and go to Page 2 of 2.
4. Click on Patient Information and enter information in the required fields (Patient ID
number, Patient Name (Last, First and Middle), Social Security number, Date of
birth (Month, Day, Year), Age (automatically calculated from Date of birth), Sex
and Race).
5. Click SAVE to store the information.
The software can store a maximum of 9999 patient information records. Patient
records should be kept up to date by deleting unnecessary records.
Figure 4.19 Patient Information Definition (System Parameters)
The information entry facility is detailed in the following screens.

Patient ID Maximum 13 characters
Patient Names Maximum 12 characters (each field)
Social Security Maximum 12 characters

+44 (0) 28 9445 1070
Extension Normal Range

Click on the EDIT button to set the extension range names. The range names must
be entered prior to setting the range values in the Chemistry Parameters screen.
Figure 4.20 Patient Information
13 characters max.
12 characters max. in each ‘Patient Name’ field.
Figure 4.21 Patient Information Screen with Details entered
List of patient information

+44 (0) 28 9445 1070
4. 4. 9. 2 ENTRY OF ORDERING PHYSICIAN, ATTENDING PHYSICIAN AND REFERRAL

PHYSICIAN DETAILS
The software provides the facility to enter and store information of the Ordering
Physician, Attending Physician and Referral Physician.
1. Select SYSTEM PARAMETERS.
2. Select SYSTEM (F9).
3. Click on the page number and go to Page 2 of 2.
4. Click on the required physician type (Ordering Physician, Attending Physician or
Referral Physician). Enter information (Maximum 32 characters) in the required
fields.
5. Click ADD and enter the physician name in the NAME field.
6. Click SAVE and the software will automatically add the new details to the list.
7. Click CLOSE to exit the screen.
Figure 4.22 Editing Physician Details
4. 4. 9. 3 ENTRY OF LOCATION, PHLEBOTOMIST AND RACE

The software offers the facility to enter and store information on the Locations,
Phlebotomist details and information on Race.
1. Select SYSTEM PARAMETERS/SYSTEM (F9).
2. Click on page 2 of 2.

+44 (0) 28 9445 1070
3. Click on the required option (Location, Phlebotomist or Race). Enter information in

the required field.
4. Click ADD and enter details as required.
5. Click SAVE and the software will automatically add the new details to the list.
6. Click CLOSE to exit the screen.
Figure 4.23 Location Details
This information can be transferred to the host computer to aid sample identification
and retrieval of results.
4. 4. 9. 4 ENTRY OF PATIENT ID AT TEST SELECTION

Patient information can also be entered during Test Selection (see Section 3.2
GENERAL OPERATING PROCEDURE” on page 55 for details on test selection
process). Enter a new Patient ID into the ‘Patient ID’ field on the RUN MONITOR/
TEST SELECT (F10) screen. When the prompt ‘ENTER SAMPLE INFORMATION
DATA’ appears select ‘YES’ to enter information.
PLEASE NOTE: if ‘NO’ is selected only Patient ID for each sample can be
entered.

+44 (0) 28 9445 1070
Figure 4.24 Entry Of Patient Information
PLEASE NOTE: Any fields with a drop down menu must be predefined as
described in Sections ‘4. 4. 9. 1 Entering Patient ID Number” on page 160’ to ‘4.
4. 9. 4 Entry of Patient ID at Test Selection” on page 163’. Patient comments and
sample comments may also be entered at this stage. When finished select
‘SAVE’ to confirm details and store in the patient database.
PLEASE NOTE: Only new or existing patient entry is possible via this screen at
test selection. It is not possible to edit patient details from this screen. To view
all patients stored in the database and edit details go to System Parameters/
System (F9) (Page 2 of 2) and select ‘Patient Information’.

+44 (0) 28 9445 1070
SECTION 5 RETRIEVAL OF RESULTS Version 2.0 Rev September 2009
SECTION 5
RETRIEVAL OF RESULTS

+44 (0) 28 9445 1070
5.1 AUTOMATIC PRINTOUT OF RESULTS

Printout and retrieval of patient results
The software provides the following options:
• Automatic Printout
• Retrieval of stored results
The software offers the following options to automatically print hard copies of patient
results:
• Print results list when sample run is complete.
• Print results in patient report form which will include all patient details and test
results.
The automatic printout facility is activated as follows:

2. In the AUTOMATIC PRINTOUT field select one of the following options.
Patient – Print results as a patient report
Result – Print result list only
Disable – Deactivate the automatic printout function.
Figure 5.1 Automatic Printout Selection, Run Monitor/Condition Screen

+44 (0) 28 9445 1070
5.2 RETRIEVAL OF STORED RESULTS

All results can be accessed in the SYSTEM PARAMETERS / RESULTS (F12) screen.
1. Select SYSTEM PARAMETERS/RESULTS (F12).
The results screen will be displayed. This screen enables the user to search for
results on the basis of sample type, sample number, date of analysis and round
number. Enter an * in all fields, except sample type, to represent the wild card and
display the results of all samples.
2. Click on the drop down menu in the SAMPLE TYPE field and select one of the
following options:
Normal Normal patient samples
Emergency Emergency patient samples
Online Patient samples requested online
Standard Calibrators
ISE standard ISE calibrators
Control Quality Control samples
Replicate Replicate samples
All All Normal, Replicate and Control samples
3. Click on the drop down menu and select either SAMPLE NUMBER or PATIENT ID
in the FROM field. Enter an * in the field to represent the wild card and display the
results of all sample numbers.
4. Click on DATE FROM and enter the YEAR, MONTH and DAY.
5. Click on DATE TO and enter the YEAR, MONTH and DAY. Enter an * in the field
to represent the wild card and display all sample results.
6. Click on ROUND # and enter the number of the sample run. Enter an * in the field
to represent the wild card and display the results of all runs.
7. Click on the drop down menu in the SEND field and select the required option.
ALL - All results
OK - Results that have been successfully transferred to host
NG - Results that have not been successfully transferred to host
8. Click on the drop down menu of the RESULTS OUTPUT screen and select one of
the following options:

+44 (0) 28 9445 1070
MONITOR (to view on screen)

PRINTER (to print out results)
FD (to save to floppy disc)
HOST (to send results to host computer).
9. Click SELECT TEST. Select the required test(s) by clicking on the relevant button
and deselect by clicking on a test button. Click on SELECT ALL to select all tests
or CLEAR ALL to cancel the test selection. Selected tests are highlighted in blue.
10. Click RETURN.
11. Click SEARCH. The software will display a list of results for all samples speci-
fied by the search criteria.
Figure 5.2 Result Selection Screen for Normal Samples
12. Click on individual results to display any flags associated with the result.
13. After selection, results can be transferred when the host communication is in
online mode. Click on the result and press the SPACE bar and the result entry is
highlighted in blue. Repeat this procedure to select additional results.
14. When results are highlighted click on the SEND SELECTED button to transfer the
information to the host computer.

+44 (0) 28 9445 1070
Figure 5.3 Test Selection Screen
Selected tests are highlighted in blue.
5. 2. 1 RETRIEVAL OF CALIBRATION CURVES

Results from previous calibrations can be sourced and displayed.
5. 2. 1. 1 RETRIEVAL OF NON-ISE CALIBRATION

1. Select SYSTEM PARAMETERS/RESULTS (F12). This screen enables the user to
search for results on the basis of sample type, sample number, date of analysis
and Round number. Enter an * in any of the selection fields to represent the wild
card and display the results of all samples.
2. Click on the drop down menu in the SAMPLE TYPE field and click on ‘STAN-
DARD’.
3. Set the search criteria for sample number, date, round number etc. as described
above.
4. Click on the drop down menu in the SEND field and select one of the following
options:
ALL - All results
OK - Results that have successfully transferred to host
NG - Results that have not successfully transferred to host
5. Click on the drop down menu in the RESULTS OUTPUT screen and select one of
the following options:
• MONITOR (to view on screen)
• PRINTER (to print out results)

+44 (0) 28 9445 1070
• FD (to save to floppy disc).

6. Click on SELECT TEST. Select the required test(s) by clicking on the relevant test
and deselect by clicking on a selected test. Click on ALL SELECT to select all
tests or ALL CLEAR to cancel the test selection. Selected tests are highlighted in
blue.
7. Click on RETURN.
8. Click on SEARCH. The software will display a list of results for all tests specified
by the search criteria.
9. To view calibration curves for a specific test click on the method box displayed in
the results list. The software will then display results for the selected test at the
bottom of the screen. Select a calibration series by clicking on the # number. The
software will display details of the date, round number, method and Lot number for
the calibration series selected. Results are displayed for up to seven calibrators
and the calibrator concentrations are also displayed.
10. To view a plot of the calibration curve go to the TIME COURSE field and select
one of the following options:
GRAPH View time course
PRINT Print time course data
FD Save data to floppy disc.
Figure 5.4 Calibrator Results
Calibration method details
Reagent Lot Nos
Calibrator Lot Nos

+44 (0) 28 9445 1070
5. 2. 1. 2 RETRIEVAL OF ISE CALIBRATIONS

1. Select SYSTEM PARAMETERS/RESULTS (F12). This screen enables the user to
search for results on the basis of sample type, sample number, date of analysis
and Round number. Enter an * in any of the selection fields to represent the wild
card and display the results of all samples.
2. Click on the drop down menu in the SAMPLE TYPE field and click on
‘ISE STANDARD’.
3. Set the search criteria for sample number, date, round number etc, as described
above.
4. Click on the drop down menu in the SEND field and select one of the following
options:
ALL - All results
OK - Results that have successfully transferred to host
NG - Results that have not transferred successfully to host.
5. Click on the drop down menu of the RESULTS OUTPUT screen and select:
MONITOR (to view on screen)
PRINTER (to print out results)
FD (to save to floppy disc)
HOST (to send results to host computer).
6. Click on SELECT TEST.
7. Select the ISE test option, selected tests are highlighted in blue.
8. Click on RETURN.
9. Click on SEARCH. The software will display a list of results for all ISE tests
specified by the search criteria.

+44 (0) 28 9445 1070
Figure 5.5 ISE Calibrator Results
5. 2. 2 RETRIEVAL OF RESULTS BY PATIENT ID

The software offers the option to display results for individual samples identified by
patient ID number (Search Patient Report).
1. Select SYSTEM PARAMETERS/RESULTS (F12).
2. Click on PATIENT REPORT. A pop up window will appear and DATE FROM and
TO are specified in the appropriate fields.
3. Click on PRINT to print the results.
Figure 5.6 Patient ID Search
5. 2. 3 VIEWING A TIME COURSE

This facility enables the user to view a time course for individual samples

+44 (0) 28 9445 1070
1. Select SYSTEM PARAMETERS/RESULTS (F12)

2. Set the results search criteria as previously described.
3. Select one of the options in the TIME COURSE box (GRAPH, PRINT or Floppy
Disc (FD).
The time course will be displayed on screen when the GRAPH option is selected.
The software enables the user to auto-define the axes by clicking on the MAX and
MIN boxes and entering the limits.
Data will be printed when the PRINT option is selected.

Data will be saved to floppy disc when the FD option is selected.
Figure 5.7 Viewing a Time Course
Y axis set to Auto

or manual Max &
Min values
Primary (Red), secondary (green) and primary – secondary (yellow) wavelength data
is displayed if appropriate.

+44 (0) 28 9445 1070
The time course scale is automatically set when the auto box is enabled. To manually
set the y axis click on the box to de-activate the selection and enter Max and Min
values as required.
When ‘STANDARD’ has been selected the reagent Lot numbers are displayed above
the timecourse as shown below.

+44 (0) 28 9445 1070
5.3 RETRIEVAL OF QUALITY CONTROL VALUES

Quality control sample results can be viewed and searched by selecting CONTROL in
the SAMPLE TYPE field in the System Parameters/Results (F12) screen.
Quality control sample results can be viewed and the information displayed as a
Levy-Jennings chart. QC results can be stored for up to 6 months and the user can
view raw data and graphs for a period of 31 days for each test method. Three levels
of QC data can be viewed.
The options on the QC (F8) job menu include:

Graphics: For graphical display of QC results over a 3-month period
Measurement: Raw data of QC data over 3-month period.
QC Settings: View test method means and SDs for different controls.
Control: Register test methods for QC controls.(See Section 3. 2. 3. 8“Quality
Control Samples” on page 73).
5. 3. 1 GRAPHIC DISPLAY
Graphic display allows the QC results on Levy-Jennings graphs to be viewed for three
levels over a 3 month period. There are two display options, Daily and Cumulative.
It is important to ensure that the QC details, mean value and SDs, have been entered
in the QC SETTINGS screen. This information is required to generate the QC graphs.
1. Select QC (F8)/GRAPHICS (F9).
test methods.
3. Click on the required test and press RETURN to select a test method. Levy-
Jennings plots for two control levels will be automatically displayed.
Control details including the mean, number SD and CV of the QC results are
displayed on screen for two control levels. The plot for a third control level may be
accessed by clicking on Page 2 of 2.
4. In the DISPLAY TYPE field select DAILY to display QC results for each day and
CUMULATIVE to display cumulative values.

+44 (0) 28 9445 1070
Results are plotted in black for normal values. If Westgard rules are applied,
results are plotted in YELLOW if they violate a WARNING rule and RED if they
violate an ERROR rule. Results indicated as an ERROR will not be included in the
overall mean, CV and SD values presented on screen.
Figure 5.8 QC Results Display Screen.
Results summary
for both levels
Click page no. to view Level 3 control
Daily display: Individual QC sample results are displayed for each day.
Cumulative results QC sample results are plotted cumulatively for each day.
All the results for one day are plotted on a vertical axis.

+44 (0) 28 9445 1070
N = Number of results
X = Mean value
SD = Standard Deviation
CV Coefficient of Variation
Plotting symbols
5. 3. 2 MEASUREMENT VALUES
This function allows QC results for each test method to be viewed for three levels
over a 3 month period. QC results for a specific parameter are displayed in date order
when the Method code is entered.
1. Select QC (F8)/MEASUREMENT (F10) on function keys.

2. Click DETAILS and the following options are displayed:
• DETAILS (to view control results between specified dates)
• DAILY (to view results for a specified day including standard deviations)
• CUMULATIVE (to view cumulative results for a time period).
test methods.
4. Select a test method by clicking on the required name and press RETURN. The
QC results for the three different levels will be displayed.
5. Click PRINT in the RESULTS OUTPUT field to print results or click on the FD but-
ton to save to floppy disc.
6. When ISE method number is selected (61 or 62) the ISE testing item box is
displayed as shown below. Click on the required options.
ISE METHOD NUMBER DISPLAY

+44 (0) 28 9445 1070
Figure 5.9 QC MEASUREMENT RESULTS (DETAILS) SCREEN
PMC level is the control value (1 to 3)
Figure 5.10 QC Measurement Results (DAILY) Screen
Enter * in the METHOD field to view daily results for a number of test methods
Enter the test method name to view information on a single test method.

+44 (0) 28 9445 1070
Figure 5.11 QC Measurement Results (CUMULATIVE) Screen
SD - Standard Deviation
Min - Minimum QC value obtained
Max - Maximum QC value obtained
5. 3. 3 QC SETTINGS
Enter details of QC samples, mean and SD (see section3. 2. 3. 8“Quality Control
Samples” on page 73 for further details).
5. 3. 4 CONTROL TYPES
Enables the registration of quality control samples and the associated test methods.
A maximum of 30 types of quality control samples may be registered. (See Section 3.
2. 3. 8“Quality Control Samples” on page 73 for further details).

+44 (0) 28 9445 1070
WARNING/ERROR CODES FOR QC VALUES

Priority Judgement Condition Status expression
1 Current result exceeds 4SD 1:4S
3 Last 2 results exceed 2SD 2:2S
5 2 out of last 3 results exceed 2SD 2/3:2S
6 Range exceeds 4SD R:4S
7 7 continue points trend 7:T[+] Increasing
7:T[-] Decreasing
8 Any 4 results exceed 1SD 4:1S
9 Any 3 results exceed 1SD 3:1S
10 10 results same side of mean 10:T[+] Greater than mean
10:T[-] Less than mean
10:X(-)F Reject when 10
consecutive control
measurements fall on one
side of the mean.

+44 (0) 28 9445 1070
5.4 RESULTS FLAGS AND ERROR FLAGS

Results flags are displayed (SYSTEM PARAMETERS / RESULTS (F12) to alert the
user if the result is outside the specified range or if a problem has occurred during
measurement.
To view results details simply click on the result value and details of concentration,
judgement value, range and flag will be displayed in the EDIT DATA field.
To delete a result click on the result entry line to highlight the value and then click on
DELETE in the EDIT DATA field. The results will be deleted from the internal results
database.
Figure 5.12 Results Flags
Result flags outside the specified range
No Flag Cause Action

1 H The measurement Check Chemistry
(Higher than upper result is above the Parameters.
limit of judgement specified normal
value) range.
2 L The measurement Check Chemistry
(Lower than lower result is below the Parameters.
limit of judgement specified normal
value) range.
3 > The measurement Check Chemistry
result is above the Parameters.
technical range.
4 < The measurement Check Chemistry
result is below the Parameters.
technical range.

+44 (0) 28 9445 1070
Error flags on routine measurement screen and results printout
Flag Brief explanation Description

SS Sample short Insufficient sample in primary tube or sample cup.
SI1 No reagent in Reagent not detected in cuvette on sample
cuvette dispense.
SI2 No diluent in cuvette Diluent not detected in cuvette on sample dispense.
R1S Insufficient Reagent Insufficient reagent in bottle or reagent volume is
1 zero on inventory.
R2S Insufficient Reagent Insufficient reagent in bottle or reagent volume is
2 zero on inventory.
DS Insufficient Diluent Insufficient diluent in bottle or diluent volume is zero
on inventory.
WS Insufficient Wash Insufficient wash solution in bottle or volume is zero
Solution on inventory.
TE1 IRU temperature low IRU temperature is lower than 36.5ºC.
TE2 IRU temperature IRU temperature is higher than 37.5ºC.
high
TE3 RCU temperature RCU temperature is higher than 15 ºC.
high
R1B No Reagent 1 bottle Reagent 1 bottle is not registered.
R2B No Reagent 2 bottle Reagent 2 bottle is not registered.
DB No diluent bottle Diluent bottle is not registered.
WB No wash solution Wash solution bottle is not registered.
bottle
IE1 No response from ISE module is not responding to sample start
ISE command sent from analyser.
IE2 No result from ISE ISE module is not sending result data to analyser.
EST Error during run Sampling terminated due to error.
LOT Erroneous lot number details entered
R1W RPT 1 wash failed Reagent 1 probe wash failed.
R2W RPT 2 wash failed Reagent 2 probe wash failed.

+44 (0) 28 9445 1070
EXP Reagent expired Reagent has expired.

STB Reagent stability Reagent has exceeded the onboard stability period.
exceeded
DUP Duplicate error Calibrator results have exceeded duplicate limit.
SEN Sensitivity error Calibration results have exceeded sensitivity limit.
CAL Calibration failed Calibration has failed.
CA? Concentration Concentration could not be calculated due to
calculation error missing calibration curve.
CLT No valid calibration No valid calibration available for onboard reagent
for reagent lot lot.
CLM No Calibration has Auto calibration is selected as "lot change" and
there is no calibration for the reagent going to be
been performed for
used for measurement.
the selected If the auto calibration is not set as "lot change" this
flag will not be generated
Reagent Lot.
LIN Linearity error Sample has exceeded linearity limit.
PRO Prozone check error Sample has exceeded Prozone limit.
AB1 Absorbance limit None or only one point is within absorbance limit
error and result calculation is not possible.
AB2 More than one point is outside the absorbance limit
but two or three are within the limit, therefore result
calculation is possible.

+44 (0) 28 9445 1070
5.5 EXAMPLES OF RESULTS PRINTOUTS

EXAMPLE-1. PRINTOUT OF RESULTS LIST (AUTOMATIC OR SEARCH)
2002/12/10 19:10:08
Sample number Sample ID
Sno_: 01 ID: A23301 Date: 20021205 Round No:001

AST
44

AST
49

AST
52 H Results flag
Sno_: R04 - #01 ID: A23304 Date: 20021205 Round No:001
AST
45

AST
43

AST
44
EXAMPLE-2. PRINTOUT OF PATIENT REPORT (SEARCH)

+44 (0) 28 9445 1070
The SEARCH patient report prints out the last 3 sets of patient test result.
EXAMPLE-3. PRINTOUT OF PATIENT REPORT (AUTOMATIC)
EXAMPLE-4. PRINTOUT OF RESULTS FOR CONTROLS

+44 (0) 28 9445 1070
EXAMPLE-5. PRINTOUT OF RESULTS FOR ISE CALIBRATION
EXAMPLE-6. PRINTOUT OF TIME COURSE DATA
This sample is for the printed time course data.
S2 Absorbance measurement of sample at primary wavelength

W2 Absorbance measurement of reagent blank at primary wavelength
S1 Absorbance measurement of sample at secondary wavelength
W1 Absorbance measurement of reagent blank at secondary wavelength

+44 (0) 28 9445 1070
EXAMPLE-7 (CALIBRATION RESULT)

This sample is for the printed coefficient of calibration result.
This sample is printed when the calibration measurement is performed normally.
1. Linear
2. Point to Point
3 Log-Logit

+44 (0) 28 9445 1070
4. Spline
5. Exponential

+44 (0) 28 9445 1070
EXAMPLE-8 (PATIENT REPORT)

EVERYONES HOSPITAL
A STREET, TOWN, CITY, COUNTRY
TEL: 1234567 FAX: 222222
EMAIL: ADMIN@.HOSPITAL.COM
2003/04/10 16:31:32
Live Patient Report
Patient Details Sample Details

Patient NameMrs Smith ij12,abcdefghij12
Patient ID123 Location abcdefghij1234567890abcdefghij12
Social Security No.123456789Date Drawn2003/09/02
Date of Birth2001/12/12Phlebotomistcdefghij12,abcdefghij12
Age 30 Sample Comments abcdefghij12345
Sex Female Sample No.001
Race xxx
Ordering PhysicianMr Jones
Attending PhysicianMr Black
Referral PhysicianMr White
Patient CommentsVery sick
Method Units Results Flag Normal Range

Na mmol/l 71.0000 0000 20- 99.99

+44 (0) 28 9445 1070

+44 (0) 28 9445 1070
SECTION 6 MAINTENANCE Version 2.0 Rev September 2009
SECTION 6
MAINTENANCE

+44 (0) 28 9445 1070
6.1 MAINTENANCE INTERVALS

This chapter details the maintenance procedures required to ensure the highest
standard of performance and safe operation of the RX daytona.
The following maintenance procedures should be performed as detailed below:

Interval Check point
Before 1. Fill system water tank with water (at least NCCLS type II
analysis water).
2. Check the remaining volumes of wash solutions in tanks and
refill if necessary.
3. Check that the end of the supply tube is at the bottom of the
system water tank.
4. Check waste tube at top of waste tank.
5. Check cuvette water blanks in Maintenance/Wash (F10) (Page
2/2).
6. Check volumes and expiry dates of ISE reagents.
7. Empty waste tanks and ensure there is sufficient printer paper.
Daily 1. Wipe any stains on the internal surface (inside outer lid) using a
clean damp cloth.
2. Use an absorbent cloth to remove any condensation in the
RCU tray.
3. Clean the outside of sample and reagent probes with a swab
impregnated with alcohol.
4. If ISE unit is present, check the remaining volume of calibrator
A and ensure tip of calibrator A tube is at the bottom of the
bottle.
5. Perform ISE cleaning as prompted when entering ‘Sleep’
mode.

+44 (0) 28 9445 1070
Weekly PLEASE NOTE: Analyser must be switched off during weekly

cleaning to allow mechanical parts to be easily moved.
1. Clean the ASP unit.
2. Clean the reagent container unit (RCU).
3. Thoroughly clean pipette cover, trough and mosaic plates
4. Remove wash unit cover and clean wash probes with a cotton
swab soaked with alcohol.
5. Carefully raise mixers and clean with a cotton swab soaked
with alcohol taking care not to bend or break the mixers
6. Visually check that solution is supplied to RPT trough.
7. Perform SPT clean with CI solution as prompted during
automatic probe wash when entering ‘Sleep’ mode.
Monthly Use reagent (RP3857) and sample (RX3856) precision test

solutions to check pipetting precision.
(See Sec- 1. Check the remaining hours left for parts in Maintenance/Wash
tion 6. 2.
(F10) screen.
5“Working
Hours Of 2. Check Alarm (F4) screen.
Expend- 3. Check IRU and RCU temperature.
able Parts”
4. Check water and wash solutions at all troughs.
on
page 208 5. Perform decontamination and cleaning of internal tubing.
6. Clean external tanks using Randox C1 wash solution (Rx 3973)
to remove any microbial contamination. Wash tubes.
7. Clean cuvettes by switching connectors for system water and
wash solution 3.
8. Check operation of fans at the rear of the analyser
9. Visually check WU filters are clean.
As required 1. Change halogen lamp (every 1000 hours).

2. Replace ISE electrodes
3. Use probe cleaning tool to clean inside of the sample probe
and reagent probe.

+44 (0) 28 9445 1070
6. 1. 1 DAILY MAINTENANCE
Pure Water and Effluent Tanks
• Check that system pure water tank is full (fill as necessary)
• Check that waste tanks are empty (empty as necessary)
• Check that the tube tip of the water tank is in contact with bottom of tank
• Check that the tube tip of the effluent tank is well above effluent level to avoid back
flow.
Detergent Tank
Check that wash solution tanks are full (fill as necessary)
Check that tube tip of detergent tank is in contact with bottom of tank.
1. To perform a cuvette check click on Maintenance/Sequence (F9). To view the
cuvette water blanks go to Maintenance/ Wash (F10). If any cuvettes are flagged
as being over the judgement value perform a cuvette wash and recheck screen. If
still above judgement value, remove affected cuvette from IRU and wash manually
in 0.1 M HCl. Replace cuvette and perform cuvette check - contact RX support if
this does not resolve the problem. At least 31 clean cuvettes are required for oper-
ation.
2. Clean the inside of the sample and reagent probes with the probe cleaning tool.
Clean the outside of the probes with a piece of gauze soaked in methanol. Always
wipe downwards from nozzle body to tip.
3. Wipe all surfaces with a clean damp cloth.
4. Use an absorbent cloth to remove any condensation in the RCU tray.
5. Check printer paper and replace as necessary.
6. If ISE unit (optional) is present carry out the following additional checks.
• Ensure sufficient volume of Calibrator A.
• Remove ISE cover and swing out ISE module, checking for any spillage around
the sampling port. Clean with a swab impregnated with alcohol (if required) to
remove any crystalline deposits, taking care not to contaminate the sampling port.
Swing ISE module back into unit and replace ISE cover.
• Perform ISE cleaning procedure at end of daily analysis by placing 500μl of ISE
cleaning solution in a sample cup at position 18 in the ASP tray and use the ‘ISE
Clean’ function in the Maintenance/Sequence (F9) screen.

+44 (0) 28 9445 1070
6. 1. 2 WEEKLY MAINTENANCE
PLEASE NOTE: The analyser must be switched off so that mechanical parts can
be easily moved. It is recommended that the RCU tray is removed and placed in
a refrigerator while cleaning is in progress.
1. Clean Automatic Sampling Unit (ASP) with a clean damp cloth.
2. Clean Reagent Container Unit (RCU) with a clean damp cloth.
3. Clean pipette cover, trough and mosaic plates thoroughly with a clean damp cloth
removing relevant sections if necessary.
4. Remove wash unit cover, carefully lift wash unit up to allow better access and
clean wash unit probes with a swab impregnated with alcohol.
5. Carefully raise mixers and clean with a swab impregnated with alcohol taking care
not to bend or break the mixers.
6. At the end of each day prior to putting the system into sleep mode, place a cup of
C1 wash solution in sample position 18 for the automatic probe wash.
When the cleaning procedure has finished replace RCU tray and switch ON the
analyser and PC. Weekly cleaning procedure should take approximately 5 – 10
minutes (see section 6.2.8 for further details).
6. 1. 3 MONTHLY MAINTENANCE
1. Carry out a sample and reagent precision check using Reagent Precision Test
solution (Cat. No. RX3857), Sample Precision Test solution (Cat. No. RX3856)
and Acid Wash Solution (WS3853). See kit inserts for procedures. If the results of
these checks are outside defined acceptable limits please contact Randox RX
support.
2. Check the remaining part hours on the maintenance wash screen.
3. Check Alarm Log and refer to the error code section for any unexplained error
codes.
4. Check IRU and RCU temperature.
5. Perform SPT/RPT (W) and SPT/RPT (C) washes from the Maintenance/Wash
(F10) screen.
6. Visually check water and wash solutions at all troughs.

+44 (0) 28 9445 1070
7. Perform decontamination and cleaning of internal tubing using the Tubing Wash
instructions. See section 6. 2. 3“Tubing Wash” on page 205.
8. Clean waste tanks using dilute hypochlorite solution to remove any microbial
contamination.
9. Check the condition of the three fans located at the rear of the chassis to ensure
that they are operating normally.
6. 1. 4 PERIODIC MAINTENANCE
Periodic checks should be carried out at regular intervals based on the use and
throughput of the analyser. To determine hours of use for various parts go to
Maintenance/Wash (F10) and perform the following if the countdown timer has
reached zero hours.
1. Replace the halogen lamp (allow 30 minutes for lamp to cool after analyser is
switched off before replacing lamp).
2. Use probe cleaning jig to remove blockages.
During analysis, periodically check the levels and tube positions in the purified water
and waste tanks.
PLEASE NOTE: Replacement of syringe tips and diaphragm pumps should only
be performed by a Randox Service Engineer.

+44 (0) 28 9445 1070
6.2 MAINTENANCE SCREEN

The maintenance screen provides test function operations performed by each unit
and displays the status of various sensors.
6. 2. 1 SYSTEM CHECKS
The MECHANICAL MAINTENANCE screen enables the user to check various
operating functions and sensors in the RX daytona analyser.
1. Select MAINTENANCE/SEQUENCE (F9).

2. Select each check by clicking on the START button as required. The instrument
will automatically commence the system check.
Figure 6.1 Maintenance Screen
System Checks Sensor checks

+44 (0) 28 9445 1070
6. 2. 1. 1 INITIALISATION
Initialises the mechanical parts of each unit.
6. 2. 1. 2 PRIME SEQUENCE
Primes the tubes for aspiration and dispense of samples and reagents in the SPT and
RPT units.
6. 2. 1. 3 SHORT PRIME SEQUENCE

Performs the short prime sequence. Enter the number of prime sequences required.
6. 2. 1. 4 CUVETTE CHECK
Assesses the degree of staining in cuvette by running a cuvette water blank
measurement.
6. 2. 1. 5 PUMP TEST
Click START in the ‘PUMP TEST’ field to check if pumps are working. The following
window will appear:
Figure 6.2 Pump Test Options
Click on the required box to activate the pump check for either the Diaphragm pump,
Waste pump or Drain pump. Enter the test time in the Time box and click OK to start
the check.
The drain pump is activated for one second on each nozzle of the wash unit (WU).
The drain pump for the trough is activated for two seconds.

+44 (0) 28 9445 1070
6. 2. 1. 6 CUVETTE WASH
Washes the cuvettes placed in the IRU unit (reaction table).
6. 2. 1. 7 CUVETTE WATER PLACEMENT

Fills the cuvettes in the IRU unit with water from the RPT nozzle to prevent cuvettes
from being stained when the equipment is not used for a long period of time.
Click on START and the following window will appear:
Select the type of wash required by selecting SYSTEM WATER or WASH
SOLUTION.
SYSTEM WATER - supplies distilled water to each cuvette.

WASH SOLUTION - Wash solution 3 from external tanks is supplied to each cuvette
CANCEL - To terminate the process.
6. 2. 1. 8 CUVETTE WATER DISPLACEMENT

Empties the cuvettes. Water is pumped out by the wash unit (WU).
6. 2. 1. 9 WU1, 3 RINSE
Moves the syringe for WU 1-3.
6. 2. 1. 10 ISE PRIME
Primes the tubes for the ISE unit. Enter the number of prime sequences required.
6. 2. 1. 11 ISE CLEANING
Cleans the ISE tubes and the ion selective electrodes using ISE cleaning solution
placed in position #19 of the sample carousel.

+44 (0) 28 9445 1070
6. 2. 1. 12 ISE CALIBRATION
A two-point calibration is run at the beginning of sample analysis. Calibrant B should
be placed in position #18 in the ASP. The calibration result is output to the SYSTEM
PARAMETERS/ISE screen.
6. 2. 1. 13 SENSOR TESTS
Sensor tests enable the user to check the operational status of sensors in the
analyser.
• Click on READ adjacent to the required sensor. All sensors can be checked by
clicking ALL.
• The status indicator will change to YELLOW when the sensor is ON and BLACK
when OFF.
• The status indicator will turn RED when the sensor has failed.
List of sensor descriptions
Sensor name Unit designa- Description

tion
IRU_ZERO IRU Position of cuvette turntable

Yellow (ON): Zero position, Disconnection: Yellow (ON)
IRU_READY IRU Position of cuvette turntable by cuvette

Yellow (ON): Normal position, Disconnection: Grey (OFF)
FLT_ZERO DTR Zero position of optical filter disk

Yellow (ON): Zero position, Disconnection: Grey (OFF)
WU_ZERO WU Zero position (upper limit) of WU nozzle

WU_OVER WU Overflow of cuvette

Yellow (ON): Overflow, Disconnection: Grey (OFF)
MIX1_ZERO MIX-1 Zero position of stirrer (MIX-1)

MIX2_ZERO MIX-2 Zero position of stirrer (MIX-2)

SPTR_ZERO SPT (Rotate) Zero position of SPT rotary movement

SPTR_TS SPT (Rotate) Dispensation position of SPT rotary movement at trough

Yellow (ON): Dispensation position, Disconnection: Grey (OFF)
SPTU_ZERO SPT (Up & Zero position (upper limit) of SPT up-and-down movement
Down) Yellow (ON): Zero position, Disconnection: Yellow (ON)

+44 (0) 28 9445 1070
SPTU_DL SPT (Up & Zero position (lower limit) of SPT up-and-down movement
Down) Yellow (ON): Lower limit, Disconnection: Yellow (ON)
SPTU_LL SPT (Up & Level detection of SPT up-and-down movement

Down) Yellow (ON): Level, Disconnection: Grey (OFF)
SPTU_LOW SPT (Up & Not used

Down)
RPTR_ZERO RPT (Rotate) Zero position of RPT rotary movement

RPTR_TS RPT (Rotate) Dispensation position of RPT rotary movement at trough

Yellow (ON): Dispensation position, Disconnection: Grey (OFF)
RPTU_ZERO RPT (Up & Zero position (upper limit) of RPT up-and-down movement
Down) Yellow (ON): Zero position, Disconnection: Yellow (ON)
RPTU_DL RPT (Up & Zero position (lower limit) of RPT up-and-down movement
Down) Yellow (ON): Lower limit, Disconnection: Yellow (ON)
RPTU_LL RPT (Up & Level detection of RPT up-and-down movement

Down) Yellow (ON): Level, Disconnection: Grey (OFF)
RPTU_LOW RPT (Up & Not used

Down)
TRF_OVER Trough Overflow at trough (SPT, RPT, MIX-1, MIX-2)

Yellow (ON): Overflow, Disconnection: Grey (OFF)
IRU_24Vm IRU Monitor of 24 VDC (IRU motor)

Yellow (ON): 24V
PP_24Vm PP Monitor of 24 VDC (SPP, RPP and WPP motors and solenoid valve)
Yellow (ON): 24V
SWU_24Vm SWU Monitor of 24 VDC (SWU pump)

Yellow (ON): 24V
BOT6_EMP External tank Spare
WPP_ZERO WPP Zero position (upper limit) of WPP syringe

SPP_ZERO SPP Zero position (upper limit) of SPP syringe

RPP_ZERO RPP Zero position (upper limit) of RPP syringe

BOT1_EMP External tank Empty detection of pure water tank

Yellow (ON): water exists (not empty)
BOT2_EMP External tank Empty detection of pure wash solution tank 1

BOT3_EMP External tank Empty detection of pure wash solution tank 2


+44 (0) 28 9445 1070
BOT4_FULL External tank Fill-up detection of low concentration waste tank

Yellow (ON): Empty
BOT5_FULL External tank Fill-up detection of high concentration waste tank

Yellow (ON): Empty
ASP_ZERO ASP Zero position of ASP turntable

RCU_ZERO RCU Zero position of RCU turntable

ASP/RCU_24Vm ASP/RCU Monitor of 24 VDC (ASP, RCU motor)

Yellow (ON): 24V
ASP/RCU24Vp1 ASP/RCU Monitor (1) of 24 VDC (Power supply of Peltier for RCU cooler)
Yellow (ON): 24V
ASP/RCU_24Vp2 ASP/RCU Monitor (2) of 24 VDC (Power supply of Peltier for RCU cooler)
Yellow (ON): 24V
CONT_YOBI1 Not used
CONT_YOBI2 Not used
CONT_YOBI3 Not used
CONT_YOBI4 Not used
CONT_YOBI5 Not used
RCU_COVER1 RCU Lid detection of RCU

Yellow (ON): With lid, Disconnection: Grey (OFF)
ASP_COVER2 ASP Lid detection of ASP

Yellow (ON): With lid, Disconnection: Grey (OFF)
6. 2. 2 WASHING PROCEDURES
1. Select MAINTENANCE/ WASH (F10).
2. The MAINTENANCE PROGRAMS screen will appear.
3. Click on START for the selected wash option (SPT for sample pipette wash or
RPT for reagent pipette wash). The term (W) after the probe description indicates
that the probe is washed with water and (C) indicates the probe is washed with
wash solution.

+44 (0) 28 9445 1070
Figure 6.3 Selection of Wash Functions
Pipette nozzles are washed with water (SPT or RPT trough).
SPT - D position
D position is the drainage position, the nozzle discards the liquid in the SPT and the
outer part of the nozzle is washed with a water jet at the trough.
RPT - D position, R position and C position.

D position Drainage position Nozzle discards liquid in the RPT.
R position Rinsing position Inside of the nozzle is washed out with water.
C position Cleaning position Inside of the nozzle is washed out with wash
solution.
6. 2. 2. 1 SPT
Washes the inside of the nozzle by discharging water at the D position. The outside of
the nozzle is washed with water at the SPT trough.
6. 2. 2. 2 SPT(S)
The SPT nozzle is washed with C1 wash solution, this is generally carried out prior to
sleep mode. The solution must be placed in position #18 in the sample tray.
Click on SPT(S) and the following screen will appear:

+44 (0) 28 9445 1070
Place the sample tube containing 500μl of C1 solution in the ASP at position #18 and
click OK. The instrument will proceed to wash the nozzle as follows:
1. SPT nozzle moves to slot #18 in the ASP and descends into the sample tube.
2. SPT aspirates 240μl of wash solution and moves to the D position of the SPT
trough.
3. SPT remains at the D position for 10 minutes.
4. SPT then descends 27.5mm downward and discharges 240μl of wash solution
and 75μl of distilled water.
5. SPT ascends to the upper limit.
6. 2. 2. 3 RPT(W)
Washes the RPT with water. The RPT moves to the D position of the trough and
discharges water. The RPT is then moved to the R position and the outside of the
nozzle is washed with water. It then aspirates 1ml of the discharged water and then
moves to the D position where it is then discharged.
6. 2. 2. 4 RPT(C)
Washes the RPT nozzle with the wash solution in the RPT trough.
6. 2. 2. 5 RPT(S)
Washes the RPT nozzle using a specified wash solution. Specify the required wash
solution in the window below:
Select R1, R2 or WASH from the pull down menu.

+44 (0) 28 9445 1070
Move the cursor to the Reagent code field and press the SPACE bar to view the
options. Select the appropriate option.
Click SAVE and then click on RPT(S) START to start the wash.
6. 2. 2. 6 SPT/RPT(W)
Washes both the SPT and RPT nozzles. Each nozzle is washed with water in the
respective trough.
6. 2. 2. 7 SPT/RPT(C)
Washes both nozzles. RPT is washed with wash solution in the RPT trough and the
SPT is washed with water in the SPT trough.
6. 2. 3 TUBING WASH
Washes the tubing line and the waste chamber as follows:
1. Click START and the following screen will appear:
2. Place all external tubes into the water tank and click OK. A full prime sequence is
performed 5 times to clean the tubes. On completion the following window will
appear:
3. Place all tubes into a tank containing C1 wash solution and click OK. All tubes are
washed for approximately 12 minutes.

+44 (0) 28 9445 1070
The following window will appear:
4. On completion the previous screen will appear prompting the user to place all the
tubes in a seperate water container (Not the water supply tank as the water will
be contaminated with C1 solution from the tubes).
The system will perform a further 5 full prime sequences.
5. The tubes are then washed with water for 12 minutes. On completion the following
window will appear:
6. Place all tubes into the appropriate solution tank and click OK. The system will
then perform three prime sequences.
7. When the tube wash is complete the following screen will appear.
8. Click OK

+44 (0) 28 9445 1070
6. 2. 4 CUVETTE CHECK
Cuvette Check enables the operator to check the cuvettes in the IRU.
1. Select MAINTENANCE/WASH (F10).
2. Select Page 2 of 2. The wavelength is specified and the readings for each cuvette
are displayed on screen. The degree of staining in the cuvettes is assessed with
reference to the judgement value. A water measurement blank is carried out
during routine measurement and the values are stored in the database. The
software automatically measures the absorbance at a number of different
wavelengths during a cuvette check. When ‘JUDGE’ is selected cuvettes are
given a colour coded warning flag on screen as follows.
RED – Cuvette has exceeded judgement value at the selected wavelength.

YELLOW - Cuvette has exceeded the judgement value at one or more other
wavelengths.
Figure 6.4 Water Blank (Cuvette check) Screen
6. 2. 4. 1 WAVELENGTH
By specifying the wavelength, the relevant measurement result can be selected. Click
on the scroll bar in the wavelength box and select the required wavelength.

+44 (0) 28 9445 1070
6. 2. 4. 2 DATE (DATE OF MEASUREMENT)

Water blank data obtained from past measurements can be selected by entering the
measurement date.
6. 2. 4. 3 JUDGEMENT VALUE
Maximum accepted value for the water blank at each wavelength. The default setting
is 5000.
6. 2. 4. 4 ACCEPTED RESULT
Water blank result for each cuvette (total 45 cuvettes) is compared with the
judgement value as indicated. If a cuvette water blank measurement exceeds the
judgement value, the cuvette will NOT be used in the next sample run. A minimum of
31 clean cuvettes below the judgement values are required for operation.
6. 2. 5 WORKING HOURS OF EXPENDABLE PARTS

The list of remaining working hours for analyser parts is displayed on the WASH
screen shown above.
2. Click RESET after the system part has been changed. The software will reset the
values to the initial values displayed in brackets.
Figure 6.5 Working Hours of Expendable Parts

Remaining Working Hours
Initial value

+44 (0) 28 9445 1070
Item Action Description
Total Working Hours None Total working hours of the analyser dis-
played.
Micro Syringe Pump Click on the RESET button Effective remaining working hours dis-
after the part has been played with initial value in parentheses.
exchanged. When remaining hours become zero, the
value changes to red.
Diaphragm Pump Click on the RESET button Initial value in parentheses and effective
after the part has been remaining hours at left.
exchanged. When remaining hours become zero, its
color changes to red.
Halogen Lamp Click on the RESET button Initial value in parentheses and effective
Drain Pump Click on the RESET button Initial value in parentheses and effective
Diaphragm Pump Click on the RESET button Initial value in parentheses and effective
(WPP,RPP,SPP,MIX1, after the part has been remaining hours at left.
MIX2,) exchanged. When remaining hours become zero, its
Pump Cassette Click on the RESET button Initial value in parentheses and effective
(For ISE unit) after the part has been remaining hours at left.
Electrode Click on the RESET button Initial value in parentheses and effective
Calibrant A Click on the RESET button Initial value in parentheses and effective
6. 2. 6 METHOD TO METHOD WASH

Enables the user to define the wash program of the RPT nozzle between defined
methods that may be sensitive to reagent carryover. The reagent probe is washed at
preset times using a wash solution.

+44 (0) 28 9445 1070
PLEASE NOTE: Using this function will increase the run time as a cycle must
be used to perform the wash.
2. Click on page 1 of 2. The wash program is displayed on screen.
Figure 6.6 Wash Program Options
Method 1
Method 1 is the method run before the RPT wash program is run.
Enter an * in the method name field to view all methods.
Method 2
Method 2 is run immediately after the RPT wash program has been run.
The wildcard * used as the method name runs all methods.
R1 → R1
The R1 reagent for method 2 is dispensed after R1 reagent for method 1.
A nozzle wash is carried out using the defined wash solution after dispensing R1 for
method 1.
R1 → R2
The R2 reagent for method 2 is dispensed after R1 reagent for method 1.
A nozzle wash is carried out using the defined wash solution after dispensing R1 for
method 1.

+44 (0) 28 9445 1070
R2 → R1
The R1 reagent for method 2 is dispensed after the R2 reagent for method 1 was
dispensed.
The nozzle wash is carried out using the defined wash solution after dispensing R2
for method 1.
R2 → R2
The R2 reagent for method 2 is dispensed after the R2 reagent for method 1 was
dispensed.
The nozzle wash is carried out using the defined wash solution after dispensing R2
for method 1.
Add (Add program)

Click to add the method-to-method wash program of the RPT nozzle.
Edit (Edit program)

Click EDIT to edit the method-to-method wash program in the wash programs list.
Delete (Delete program)

Deletes the selected method-to-method wash program in the wash programs list.
Cancel
Cancels the above addition or edition.
Save
Saves addition, edition and deletion of the method-to-method wash program.
Wash solutions are registered in System (F9) /System Parameters.
This method-to-method wash has precedence over the ’RPT wash’ specified in the
Chemistry Prm/Chemistry (F9).
How to set up the method-to-method wash program

Define the wash program of the RPT nozzle as follows:
1. Go to the MAINTENANCE WASH screen.

+44 (0) 28 9445 1070
2. Click on ADD or EDIT.

The following pop-up window will appear.
Figure 6.7 Method to Method Wash Options
Select Test Method 1 and Test Method 2

Move the cursor onto the Method 1 or Method 2 box and press the SPACE key to
display the method list pop-up window. Select the required method and press
ENTER.
Figure 6.8 Selection of Test Methods from the Method List
Press ESC to close the method list.
Wash programming (R1 to R1, R1 to R2, R2 to R1, R2 to R2)

The following three options for washing are available:
System Water
Wash Sol. C
Wash Bottle.

+44 (0) 28 9445 1070
Click on the relevant wash solution name. When WASH BOTTLE is selected the
bottle code must be specified. Click on the WASH CODE field and press the SPACE
BAR to view the methods. Select the required method or ESC to cancel.
Click on OK to select the structured method-to-method wash program.
Click on CANCEL to cancel the structured method-to-method wash program.
Saving the method-to-method wash program

Click on SAVE to save the structured method-to-method wash program.
6. 2. 7 PERFORMANCE CHECK FACILITY

Enables the temperature of the IRU and RCU to be checked during operation and
performs a wavelength check of onboard filters.
1. Select MAINTENANCE/PERFORMANCE (F11). The temperatures of the 3
heaters in the IRU and the temperature inside the RCU, are displayed.
Figure 6.9 Onboard Sensor Performance

+44 (0) 28 9445 1070
PLEASE NOTE: Early analysers were supplied with alternative filters, therefore
this screen will display the corresponding wavelength filters on board the
analyser.
Detector Performance Monitor

Detector auto-gain function is checked and monitored.
Title Description
Wave Length 8 wavelengths
Coarse Coarse gain adjustment
Fine Fine gain adjustment
Offset Offset amount for gain-origin matching of each wavelength
Voltage Gain adjustment voltage (to be adjusted within

4.0Å ± 0.5 V)
Absorbance Absorbance at the above gain voltage.
Manual button Manual gain adjustment normally used for factory adjustment)
Automatic button Automatic gain adjustment
Optical Axis Parameter of DTR optical axis adjustment (factory adjusted before ship-
ment)
Volume Adjustment & nL/pulse

This parameter is adjusted before shipment.
6. 2. 8 AUTOSTART
Enables the user to preset the timing of system initialisation and prime for each day of
the week. The system can automatically initialise and prime outside normal working
hours ensuring the analyser is ready for operation as soon as the user arrives in the
laboratory. Options for automatic settings include:
• time at which analyser is switched on;
• number of times the prime process is performed when initiated.
• number of times the wash process is performed when initiated.
PLEASE NOTE: SLEEP MODE must be selected on analyser shutdown to use

this facility.

+44 (0) 28 9445 1070
Figure 6.10 Automatic Startup (AUTOSTART) Screen
Scheduling
The system start-up time and sequence of measurement preparation group can be
specified during the week (Monday to Sunday).
’Time’: Enter the system start-up time of each day (00:00:00 – 24:00:00)
’Prep’: Select the type of preparation to be carried out at the time of system
start-up (Off, Prep1 or Prep2).

+44 (0) 28 9445 1070
Prep1/Prep2
The operational sequence is defined for two selected types of preparation (Prep1 and
Prep2).
Measurement preparation
Prime: Select from 1 to 5 times (0: Off)
ISE Prime: Select from 1 to 5 times (0: Off)
SPT Wash: Select from 1 to 5 times (0: Off)
RPT Wash: Select from Off, W1 – W5 and C1 – C5
where W2 means 2 pure water washes and C2 means 2
wash solution washes.
Cuvette Wash: Select from 1 to 5 times (0: Off)
Auto prime parameter

When ’AUTO PRIME MODE’ is selected (Run Monitor(F5) /Condition(F12)), the
following options become effective during start up of the analyser (Short prime
interval, Full prime interval and Number of Short Prime).

+44 (0) 28 9445 1070
Figure 6.11 Time Chart for Auto Prime Mode
Auto gain
control only Auto gain & short prime Auto gain & full prime
executed sequence executed sequence executed
Time
Previous
measurement
finish time
Short prime interval (60min)

Full prime interval (240min)
6. 2. 8. 1 TIME AND SETTINGS

Click on the TIME box and alter the preset time for each day of the week.
6. 2. 8. 2 PREPARATION FOR AUTOSTART

Select the prime conditions by clicking on the scroll arrow and selecting either PREP
1 or PREP 2. PREP 1 and 2 conditions are entered on the right of the screen as
shown below.
PRESET PREPARATION CYCLES FOR AUTOSTART.
Type of Prep1 Prep2

operation
Prime Number of prime operation: 0 – 5 Same as
Prep1
ISE Prime Number of prime operation: 0 – 5 Same as
Prep1
SPT Wash Number of prime operation: 0 – 5 Same as
Prep1

+44 (0) 28 9445 1070
RPT Wash Off: Not washed

W1: Wash with pure water – once
W2: Wash with pure water – twice
W3: Wash with pure water – three times
W4: Wash with pure water – four times Same as
W5: Wash with pure water – five times Prep1
C1: Wash with Wash solution 3 – once
C2: Wash with Wash solution 3 – twice
C3: Wash with Wash solution 3 – three times
C4: Wash with Wash solution 3 – four times
C5: Wash with Wash solution 3 – five times
Cuvette Number of washes: 0 – 5 Same as
Wash Prep1
6. 2. 9 CLEANING PROCEDURES
Cleaning procedures are necessary to ensure optimal performance of the analyser.
6. 2. 9. 1 CLEANING EXTERNAL TANKS

Switch off the analyser and empty all liquid from the three external tanks. Clean and
wash the tanks with dilute hypochlorite solution and rinse with de-ionised water.
Ensure that all wash water has been removed before replacing solutions.
6. 2. 9. 2 SPT OR RPT
1. Move the nozzle assembly upwards by hand to gain access to the nozzle.
2. Moisten a small piece of gauze with alcohol.
3. Starting at the top, wipe the pipette with the gauze down the entire length of the
pipette as shown in Figure 6.12“Cleaning SPT and RPT Nozzles” on page 219.
CAUTION: Be careful not to apply force to the nozzle assemblies as it may

result in alteration of nozzle alignment and incorrect functioning of the
analyser. Always wear gloves when handling the analyser or accessories.

+44 (0) 28 9445 1070
Figure 6.12 Cleaning SPT and RPT Nozzles
If the inside of the nozzle is blocked, the nozzle cleaning jig can be inserted to remove
the blockage. Carefully insert the nozzle cleaning jig by hand into the pipette nozzle.
PLEASE NOTE: The nozzle jig has two needles:

• Thin needle for the SPT
• Thick needle for the RPT and WU.
6. 2. 9. 3 CLEANING THE WU NOZZLES

WARNING: Turn off power to the analyser before cleaning.
The WU unit has two independent drainage nozzles and six pairs of nozzles, each
pair consisting of one drainage and one injection nozzle.
Each nozzle should be cleaned with Ethanol. Before cleaning the nozzles remove the
SWU cover (see Figure 6.13“Removal of SWU Cover” on page 220).

+44 (0) 28 9445 1070
Figure 6.13 Removal of SWU Cover
M3 screw
plastic clip
1. Lift the nozzle unit with one hand.

2. Wipe each nozzle with alcohol using gauze or cotton swabs.
If the inside of the nozzle is blocked the nozzle cleaning jig may be used, as
described in section 6. 2. 9. 2“SPT or RPT” on page 218.
3. Lower the nozzle unit.
6. 2. 9. 4 MIX-1/MIX-2 (STIRRING PADDLES)

WARNING: Before starting the following procedure, make sure that the analyser
is switched off.
There are two stirring paddles: MIX-1 is located near the RPT unit, MIX-2 is inside the
panel cover located near the ASP. (Refer to analyser overview section for location of
MIX-1 and MIX-2). The panel must be removed before cleaning the MIX-2 stirrer.
1. Move the stirring paddle assembly upwards by hand.
2. Moisten a small gauze square or swab impregnated with alcohol and wipe the
stirring paddles gently. Wipe with distilled water and return to original position.
6. 2. 9. 5 WATER SUPPLY SYSTEM

Clean the water supply lines using the Tubing Wash procedure (see section 6. 2.
3“Tubing Wash” on page 205) to help prevent bacterial growth. Keep the analyser
switched on during washing of water supply lines, and make sure that the external
tanks are filled with sufficient water and wash solution.

+44 (0) 28 9445 1070
6. 2. 9. 6 CUVETTE
1. Select MAINTENANCE/SEQUENCE (F9).
2. Press the START button of the ’CUVETTE WASH’ to start cleaning.
6. 2. 9. 7 SAMPLE COMPARTMENT (ASP)

1. Check that the SPT pipette assembly is not positioned over the sample
compartment. If it is, rotate the nozzle assembly out of the way by hand.
2. Take out the ASP tray.
3. Wipe the barcode reader window frame with gauze soaked in ethanol.
Figure 6.14 Cleaning the Inside of the ASP
4. Dry the inside of the sample compartment with gauze or a paper towel.
5. Replace the ASP tray.
6. Return the SPT pipette to above the trough position
6. 2. 9. 8 REAGENT COMPARTMENT (RCU)

1. Check that the RPT pipette assembly is not positioned over the reagent
compartment. If it is, rotate the pipette assembly by hand.
2. Take out the RCU tray.

+44 (0) 28 9445 1070
Figure 6.15 Cleaning the Inside of the RCU
3. Clean the inside of the reagent compartment with gauze or a paper towel as
shown. Make sure that all condensation is removed.
4. Replace the RCU tray and close the lid.
5. Return the RPT pipette to above the trough position.
6. 2. 9. 9 MOSAIC PLATE
Clean the surface of the mosaic plates with Ethanol moistened gauze or a paper
towel.
Figure 6.16 Cleaning the Mosaic Plates.

+44 (0) 28 9445 1070
6. 2. 9. 10 DUST FILTER
Two dust filters are provided on the inner surface of the left and right side cover (see
diagram below).
Inspect the filters and clean the filters when required. If filters are damaged or appear
heavily contaminated they should be replaced.
WARNING: The analyser should be switched off before cleaning or replacing

filters.
Figure 6.17 Location of Filters
FILTER R2
D200-0058
FILTER R2
D200-0058
6. 2. 10 PARTS REPLACEMENT
The following specialist tools are required when replacing parts.
• Allen wrench sizes 0.9 mm and 1.5 mm
• Nozzle height adjustment tool (common to both SPT and RPT)
• Stirrer height adjustment tool (common to both Mix-1 and Mix-2)
• Syringe Plunger tip insertion jig.
6. 2. 10. 1 SYRINGE TIP REPLACEMENT

Syringe plunger tips should be replaced by a Randox Service Engineer.

+44 (0) 28 9445 1070
6. 2. 10. 2 STIRRER REPLACEMENT (MIX-1/MIX-2)

Replacement of stirrers should be performed by a Randox Service Engineer
6. 2. 10. 3 PIPETTE REPLACEMENT (SPT/RPT)

WARNING: Turn the analyser power switch off before starting. This procedure
should only be performed under advice by RXsupport.
Exchange procedure
1. Move the pipette into an easily accessible position.
2. Loosen two M3 screws from each side and remove the arm cover.
Figure 6.18 Removal of Pipette Arm Cover
M3 screws

+44 (0) 28 9445 1070
Figure 6.19 Removal of Pipette Nozzle

cable connection
Allen hex screw (M2x4) pipette connector nozzle plate
3. Unplug the cable connector from the PCB.

4. Unscrew the pipette connector.
5. Remove the allen hex screw (M2x4) and lift out the pipette.
6. Install the new pipette carefully as below, ensuring that the allen head screw is not
overtightened.
Check the nozzle height using the nozzle position adjustment jig.
1. Cover the nozzle with the nozzle position adjustment jig so that the top
of the jig hits against the lower surface of the nozzle plate and the tip of the
nozzle touches the bottom of the jig.
2. Push down the nozzle.
3. Adjust the nozzle height by loosening the Allen hex socket screw (W-point, M2x4)
using the Allen wrench (0.9 mm).
4. Make sure that the nozzle moves up and down smoothly.
5. The nozzle needs to move up and down smoothly in order for the lower limit
sensor to operate properly. This occurs when the tip of the nozzle hits the
bottom of the reagent bottle or sample tube.

+44 (0) 28 9445 1070
Figure 6.20 Height Adjustment for Pipette Nozzle
6. 2. 10. 4 REPLACEMENT OF HALOGEN LAMP

The halogen lamp needs to be replaced after every 1000 hours of use.
Call up the Performance (F11) picture of the job menu (Maintenance) and click on the
’DETECTOR PERFORMANCE MONITOR’ button. If the voltage at each wavelength
does not fall within 4.5 ± 0.5 V, the lamp needs to be replaced. Follow the procedure
detailed below to replace the halogen lamp.
Replacement Procedure
WARNING: Turn the analyser power switch OFF before starting work.
1. Allow at least 30 minutes for the lamp to cool.
2. Do not touch the glass part of the lamp.
3. Do not apply force at the joint portion of the lead wire to prevent damage.
4. Take off the mosaic plates 4, 5 and 9 (see section 6.2.8.7 Mosaic Plates).
5. Disconnect the plug (D200-0001).
6. Unscrew the two screws (D200-0256) from the lamp case.
7. Lift up the lamp case holding its resin handle.
8. Loosen two screws fixing the lamp to the lamp case and pull out the lamp.

+44 (0) 28 9445 1070
Figure 6.21 Removal of Halogen Lamp
D200-0256
D200-0001
9. Place a new lamp in position and fasten the two screws while pressing the lamp in
the direction of arrow as shown below.
Figure 6.22 Positioning New Lamp

+44 (0) 28 9445 1070

+44 (0) 28 9445 1070
SECTION 7 TROUBLESHOOTING Version 2.0 Rev September 2009
SECTION 7
TROUBLESHOOTING

+44 (0) 28 9445 1070
7.1 TROUBLESHOOTING
When troubleshooting the RX daytona the following initial checks should be carried
out:
• Correct preparation and storage of reagent
• Correct preparation and storage of sample
• Correct operation of equipment
• System maintenance has been performed
Please contact Randox RX Support if electrical or mechanical system faults are

identified. For safety reasons the user should NOT carry out internal inspections of
the analyser.
7. 1. 1 ANALYTICAL PROBLEMS
When contacting RX Support for troubleshooting please have the following
information available.
1. Analyser serial number.
2. Method code.
3. Description of problem.
4. Serial number and lot number of reagent, calibrator and quality control sample.
5. Recent results of calibrations.
6. Recent results of quality control samples.
7. Measurement results.
8. Copy of the ‘DBbackup save’ folder
7. 1. 2 EQUIPMENT PROBLEMS
1. Serial number.
2. Current software version number.
3. Problem description and details of relevant alarm codes.
4. Any other information about equipment or maintenance.

+44 (0) 28 9445 1070
7.2 MALFUNCTION AT POWER ON

The following procedure should be followed if the system does not activate when the
power is switched on.
1. Check that the main switch located on the left side panel of the equipment is at the
’ON’ position.
2. Turn the power switch OFF and check the main fuses located underneath the
power cable socket (See below).
3. Pull out the analyser power supply cable and open the fuse cover as shown
below.
Figure 7.1 Replacement of Fuses
4. Pull out the fuses and check for signs of burn out. Replace any damaged fuses as
necessary.
5. Check that the power supply circuit breaker for the equipment is connected and
functional.
PLEASE NOTE: For continued protection replacement fuses must be of the

same type and rating as the original. All fuses used must be UL approved.

+44 (0) 28 9445 1070
7.3 ANOMALOUS RESULTS

Analytical errors may be identified by on screen error flags or the appearance of
unexpected results. Error flags may appear for calibration results, quality control
sample results or normal sample results.
When anomalous results appear, assess the source of the problem by checking the
reagents, calibration samples and quality control samples. Then determine the
following:
1. Are anomalous results high in a specific method for all samples?

2. Are anomalous results low in a specific method for all samples?
3. Are anomalous results random?
4. Are there two or more anomalous measurement results for all methods or is there
no pattern to the erroneous results?
7. 3. 1 CHECK REAGENTS, CALIBRATORS, QC AND PATIENT SAMPLES

The following checks should be carried out to determine the cause of high, low or
random anomalous results.
1. Storage, preparation and use of reagents, calibrators and QC samples adhere to

the manufacturer’s recommendations.
2. Reagent has not expired.
3. Control and calibrator samples have been prepared according to the
manufacturer’s recommendations.
4. Patient samples do not contain fibrin and blood cells (these should be removed
prior to analysis).
5. Serum is not haemolysed, icteric or lipaemic.
6. Evaporation has not caused sample concentration.
7. Bubbles are not present in the reagents or patient samples as this may affect
aspiration volume.
8. Routine system maintenance is up to date.

+44 (0) 28 9445 1070
Preparation of reagent
1. Was there any change of reagent?
2. Is the on board stability of the prepared reagent still valid?
3. Was the reagent prepared using the correct procedures?
4. Is the reagent lot expiry date still valid?
5. Was the reagent prepared using fresh, non-bacteria contaminated and deionised
water or appropriate diluent?
6. Has the reagent been scanned.
Preparation of QC sample
1. Was the preparation volume correct?
2. Has the sample been stored as recommended?
3. Is the sample stability still valid?
4. Was the sample prepared using a calibrated pipette?
5. Is the control lot expiry date still valid?
6. Was the sample prepared using appropriate diluents?
Preparation of calibrator
1. Was there any change of the lot number?
2. Was the calibrator prepared using the correct volume?
3. Has the calibrator been stored as recommended?
4. Is the calibrator stability period still valid?
5. Was the calibrator prepared using a calibrated pipette?
6. Is the expiry of the calibrator lot still valid?
7. Was the calibrator prepared using appropriate diluents?
For further investigation, refer to the following list after the above checks have been
completed.

+44 (0) 28 9445 1070
7. 3. 2 HIGH VALUES
Cause Action
Incorrect calibration Check the preparation of standard/calibration sample.
Check that the calibration settings are correct. The
calibration should be repeated.
Incubation temperature too Check the temperature indicated on the Run Monitor.
high Call customer service department when the indicated
temperature deviates from 37 ± 0.5ºC.
Improper preparation of Check that the reagent was prepared according to
reagent manufacturer’s recommendations.
Improper preparation of Check that the standard sample was prepared
standard sample according to manufacturer’s recommendations.
7. 3. 3 LOW VALUES
Cause Action
Reagent expired Check the reagent expiry date.
Improper reagent Check that the reagent was prepared correctly.
preparation
Improper reagent storage Check the recommendations for storage
conditions.
Incubation temperature Check the temperature indicated on the Run
too low Monitor. Call customer service department when
the indicated temperature deviates from 37 ±
0.5ºC.
Improper preparation of Check the preparation of calibration material.
calibration material
Excessive volume of Check if there is any leakage at junction of
sampled reagent reagent sampling system.
7. 3. 4 RANDOM ERRONEOUS RESULTS
Cause Action
Contamination of SPT Perform nozzle washing on the Maintenance/Wash (F10)
and RPT screen and check if enough wash water is dispensed at
trough. Call customer service department if the problem
remains

+44 (0) 28 9445 1070
Fibrin clots formed on Clean SPT nozzle (Probe unblocking tool).

specific sample tube
or sample cup
Insufficient water or Check that the tips of the water and solution supply tubes
solution supply from are located below water or solution level. Call customer
external tank service department if the problem remains.
Insufficient stirring Check that the stirrer rotates at the correct speed in the
centre of the cuvette.
7. 3. 5 ERRONEOUS VALUES FOR ALL SAMPLES WITH A SINGLE

PARAMETER
Cause Action
Incorrect preparation of Prepare new reagent according to the
reagent manufacturer’s recommendations.
Reagent expired, Prepare new reagent according to manufacturer’s
contaminated or visual recommendations.
change in reagent
presentation.
7. 3. 6 ANOMALOUS RESULTS WITH TWO OR MORE PARAMETERS
Cause Action
Leakage in the SPT or Check junctions of probe and syringe.
RPT sampling system
Anomalous incubation Check the temperature indicated on the Run Monitor.
temperature Call RX Support when the indicated temperature
deviates from 37 ± 0.5ºC.
Insufficient stirring Check if stirrer rotates at the correct speed in the
centre of cuvette.
Carry over of pipettes Wash the pipettes and stirrers at the respective
(SPT and RPT) and trough.(6. 2. 2. 1“SPT” on page 203 to 6. 2. 2. 7“SPT/
stirrers. RPT(C)” on page 205).

+44 (0) 28 9445 1070
7.4 EQUIPMENT MALFUNCTION

Troubleshooting equipment malfunction is not recommended (except where specified
in this manual). If equipment problems arise that are not specified, please contact RX
Support. DO NOT, under any circumstances, attempt to perform mechanical or
electrical alterations to the analyser.

+44 (0) 28 9445 1070
7.5 MECHANICAL PROBLEMS

All mechanical system checks may be initiated using the software functions. If a
problem arises, the software will specify the source of the problem and visual alarms
are presented on screen.
If a problem arises that may affect the analyser performance, all sampling should be
stopped using the emergency stop action. When sampling stop mode is initiated the
analyser will complete processing samples that have already been aspirated.
Mechanical problems not controlled by the software will not appear on screen as an
error message. These would include problems such as abrasion of parts, leakage in
the sampling system, etc. If this happens, decide whether sample processing should
proceed or whether measurement should be terminated due to possible damage to
the analyser.
The software generates the following message types:

Result-related flags.
Equipment alarms.

+44 (0) 28 9445 1070
7.6 RESULTS FLAGS

When the measurement result of a sample is higher or lower than the defined value,
the appropriate flag is printed out with the result.
7. 6. 1 RESULTS OUTSIDE THE SPECIFIED RANGE

Results are printed out with result flags as follows:
No Flag Cause Action

1 H The measurement Information only.
(Higher than upper result is above the
limit of normal range) specified normal range.
2 L The measurement Information only.
(Lower than lower result is below the
limit of normal range) specified normal range.
3 > The measurement Information only.
result is above the
technical range.
4 < The measurement Information only.
result is below the
technical range.
5 r Result from re-run

+44 (0) 28 9445 1070
7.7 ERROR FLAGS

Results are printed out with error flags as shown in the following list (see error codes
in section 5.4“RESULTS FLAGS AND ERROR FLAGS” on page 181).
No. Flag Cause Action

1. SS SPT tip hits the bottom of the Check the sample volume in
tube or cup during aspiration the sample tube or sample
of sample. (Sample could not cup.
be aspirated.)
2. SI1 SPT tip hits the bottom of Check the level sensor and
cuvette at the time of sample associated parts.
dispense. (Sample could not
be dispensed).
3. SI2 SPT tip hits the bottom of Check the level sensor and
cuvette at the time of diluent associated parts.
dispense (Diluent could not
be dispensed).
4. R1S RPT tip hits the bottom of the Check R1 reagent volume.
bottle at the time of aspiration
of R1. (Shortage of R1
reagent)
5. R2S RPT tip hits the bottom of the Check R2 reagent volume.
bottle at the time of aspiration
of R2. (Shortage of R2
reagent)
6. DS RPT tip hits the bottom of the Check the diluent volume.
bottle at aspiration of diluent.
(Shortage of diluent)
7. WS RPT tip hits the bottom of the Check wash solution volume.
bottle at aspiration of wash
solution. (Shortage of wash
solution)
8. TE1 Inside temperature of the IRU Check the IRU unit.
is lower than 37ºC.
9. TE2 Inside temperature of the IRU Check the IRU unit.
is higher than 37ºC.
10. TE3 Inside temperature of the Check the RCU unit.
RCU is higher than 15ºC.
11. R1B R1 reagent bottle has not Check that the barcode label
been registered. is registered on System
Parameters/System screen.

+44 (0) 28 9445 1070
12. R2B R2 reagent bottle has not Check that the barcode label
been registered. is registered on System
13. DB Diluent bottle has not been Check that the barcode on the
registered. label is registered on System
14. WB Wash solution bottle has not Check that the barcode on the
been registered. label is registered on System
15. IE1 No response from ISE unit to Check the ISE unit.
sampling start command.
16. IE2 No measurement result is Check the ISE unit.
sent from ISE unit.
17. EST Error arises during run and Check the error number.
sampling is interrupted.
18. LOT Mismatch of R1 and R2 lot Check R1 & R2 lot numbers
numbers
19. R1W RPT wash between methods Repeat affected results
fails. (Timing of R1)
20. R2W RPT wash between methods Repeat affected results
fails. (Timing of R2)
21. EXP Reagent has expired. Replace the reagent.
22. STB Reagent stability has expired. Replace the reagent.
23. SPW SPT wash has failed Check the relevant alarm
24. CTO Calibration has expired Run a new calibration for the
test and re-apply to the
measurement.
25. DUP Variation in calibration results Repeat Calibration. If flag
exceeds allowable range. obtained again, contact
(Variation in duplicate and Randox RX Support
triplicate measurement
results)
26. SEN Difference in absorbance Repeat Calibration. If flag
between STD(min) and obtained again, contact
STD(max) is out of range for Randox RX Support
the calibration measurement.
27. CAL Calibration measurement Repeat Calibration. If flag
failed. obtained again, contact
Randox RX Support

+44 (0) 28 9445 1070
28. CA? Unable to calculate results. Repeat Calibration. If flag

obtained again, contact
Randox RX Support
29. OVR Concentration is outside the Sample should be diluted and
valid calibration range. re-run if automatic re-run is
not enabled.
30. LIN Linearity exceeds allowable Sample should be diluted and
limit. re-run if automatic re-run is
not enabled.
31. PRO Exceeds prozone limit. Sample should be diluted and

re-run if automatic re-run is
not enabled.
32. AB1 The absorbance exceeds the Sample should be diluted and
allowable limit at 1 measuring re-run if automatic re-run is
point. not enabled.
33. AB2 Absorbance exceeds the Sample should be diluted and

allowable range of 2 or more re-run if automatic re-run is
measuring points. not enabled.
34. CLT No valid calibration available Run a calibration with new

for onboard reagent lot. reagent lot.
35. CLM No Calibration has been Auto calibration is selected as
performed for the selected "lot change" and
Reagent Lot. there is no calibration for the
reagent going to be used for
measurement.
If the auto calibration is not
set as "lot change" this flag
will not be generated.
Run a calibration with the new
reagent.

+44 (0) 28 9445 1070
7.8 5-MINUTE TROUBLESHOOTING GUIDE

When a problem occurs:
Firstly check alarm codes against Section 8 in the Operator Manual and refer to the
'Trouble Shooting Guide'.
A quick phone call to Randox RXsupport staff will sometimes be sufficient to solve the
problem immediately, however if support staff don't know your programme settings,
calibration data and QC results it can make it very difficult to resolve the problem.
It only takes 5 minutes to collect data and the following 6 points will help us to quickly
find the solution.
7. 8. 1 1. PROGRAM SETTINGS
Please forward a copy of the analyser program screen with every query to enable
RXsupport to check the settings.
1. Select CHEMISTRY PRM / CHEMISTRY from the menu options to display the
program screen.
2. Press CONTROL and F5 to send a copy of the screen to the printer. Fax the
information to RXsupport.
To email a copy of the program settings.

1. Select the required screen and press PRINT SCREEN.
2. Click on the Windows START button and go to PROGRAMS, ACCESSORIES and
PAINT program.
3. When in the paint program ensure the page is correctly orientated to receive your
print screen. To do this go to PAGE SET UP and set the orientation to landscape
format with the margins reduced to the minimum.
4. Go to EDIT and select PASTE. Once the copy is pasted into paint save on a floppy
disk as a JPEG file or 16-bit colour bmp image if using Windows NT.

+44 (0) 28 9445 1070
Figure 7.2 Program Settings Screen
7. 8. 2 CALIBRATION INFORMATION
Please forward a copy of the calibration screen to enable Randox RXSupport to
assess the calibration parameters.
1. Select CALIBRATION/CALIBRATION (F9) Page 1 of 2.

2. Select the calibration method and click on PARAMETERS to open the calibration
details.
3. Print the screen or prepare an electronic copy of the screen and forward to
RXSupport.
Figure 7.3 Calibration Screen

+44 (0) 28 9445 1070
7. 8. 3 CALIBRATION CHECK INFORMATION

1. In the calibration screen select CHECKS (F10) to display the required information.
2. Print the screen or prepare an electronic copy of the screen and forward to RX
Support.
Figure 7.4 Calibration Checks Screen
7. 8. 4 CALIBRATION RAW DATA & EQUATION
1. Go to SYSTEM PRM / RESULTS (F12).

2. Select STANDARD Sample Type.
3. Select the required test and click on SEARCH.
4. In the RESULTS OUTPUT field select FD to transfer the information to a floppy
disc or PRINT to print the data to the printer. When FD is selected the file is
exported as a csv file that can be imported into Excel.

+44 (0) 28 9445 1070
Figure 7.5 Data Search Screen
If the PRINT option was selected fax a copy of the calibration report.
7. 8. 5 CALIBRATION TIME COURSE

Copies of the raw data or time course data for each of the calibration points (minimum
4, blank and serum in duplicate) are also required. This information can be accessed
as described in point 4. above. These may be sent as csv files or can be faxed as
data printed from the analyser. To save the raw data onto a floppy disk, bring up the
calibration and use the time course button to produce the data for each highlighted
point.

+44 (0) 28 9445 1070
Figure 7.6 Calibration Data Search Screen
7. 8. 6 QC INFORMATION
Details of quality control sample recovery are also required. This should be sent as a
screen shot of the results searched and information from the QC management screen
1. Select QC/GRAPHICS and select the required method.
2. Prepare an electronic copy of the screen or print the information to the printer and
fax to RXSupport.
Figure 7.7 QC Management Screen
We may request a copy of raw data or time course data for controls run.
We want to help as quickly as possible, so please use the '5 minute data collection'
for problem solving.

+44 (0) 28 9445 1070
SECTION 8 ALARM CODES Version 2.0 Rev September 2009
SECTION 8
ALARM CODES

+44 (0) 28 9445 1070
8.1 ALARM CLASSIFICATION AND ERROR CODES

This section provides a summary of the alarm codes that may appear on screen when
an error or alarm occurs during operation.
8. 1. 1 ALARM CODE CLASSIFICATION

All mechanical and electrical malfunctions detected by the software will appear on
screen as an alarm message. When an error occurs, the visible alarm is generated
immediately.
The ALARM (F4) box on the Global menu screen will flash RED. Press (F4) to view
the alarm screen which will show the error code and details.
Classification Type of alarm Description

1 Emergency Stop This is a critical error and the
operation stops immediately.
2 Alarm 1 Sampling is interrupted.
Measurements will continue for
samples that have been sampled.
3 Alarm 2 Message is displayed for information
only. The measurement is not
stopped.
8. 1. 2 ALARM OUTPUT
Alarm messages are displayed on screen whereas results flags appear when the
results are printed out and on the System Parameters/Results screen. Certain result
flags are also displayed on the Run Monitor/Run Monitor (F9) screen along with the
result value.
8. 1. 3 ALARM CODE NUMBERS

The alarm code number consists of a combination of the unit and error number
assigned to each error.
Each alarm code has 4 digits and consists of a 2-digit unit number and 2-digit error
number (e.g. 2252, where 22 is the unit number and 52 is the error code number.).
• Unit numbers assigned: 01 – 99
• Error numbers assigned: 01 – 99

+44 (0) 28 9445 1070
8.2 ALARM MESSAGES

Alarm message information may apply to either a system error or a unit error.
8. 2. 1 SYSTEM ERRORS
ERROR MESSAGE ACTION

CODE
E0075 System file not recognised System file /home/kogata/sysboot/system/system.txt or

khan.txt cannot be found. Contact RX support.
E2875 Insufficient sample volume. Check sample volume in cup/tube in asp. If sufficient sample
Test not run. volume re-initialise the analyser. If error is not cleared
contact RX support.
E6002 Concentration calculation Concentration calculation from measured results is

error. impossible.
Check that the settings in [calibration][calibration (F9)]
screen are correct.
E6003 Full calibration failed. Full calibration failed.

Check that the settings for concentration values in the
[calibration][calibration (F9)] screen are correct. Check that
the calibrator set in the ASP unit is correct.
E6004 Full, one point or two-point Full, one point or two-point calibration failed.
calibration failed. Check that the settings for concentration values in the
[calibration][calibration (F9)] screen are correct. Check that
the calibrator is correctly placed in the ASP unit.
E6005 Printer output failed. Printer output failed. check that the cable is connected
correctly. Check that the printer is in the ’ready’ condition.
E6006 Not defined.
E6007 Not defined.
E6008 Invalid standard sample There is a calibrator whose concentration value is defined.
found. Check [calibration][calibration (F9)] parameter settings.
E6009 Concentration information The concentration value is not defined.

not available. Define the correct concentration values for the necessary
number of calibrators at the calibration screen
E6010 Not defined.
E6011 Data reception error. Invalid data has been received. Please ensure data from
host conforms to format defined in the ASTM host
specification document.
E6012 Software interrupted. Software interrupt occurred at the time of concentration

calculation, overflow or division by zero. Please rerun
affected sample.
E6013 BCC error occurred during BCC error occurred during host communication.
host communication. Check that the settings for communication at the system
parameters screen are correct.

+44 (0) 28 9445 1070
E6014 Time out error occurred No response from the host computer.
during host Check that the connection to the host computer is correct.
communication.
E6015 Re-transmission error No response to re-transmission of data from the host

occurred during host computer. Check that the connection to the host computer is
communication. correct.
E6051 Not enough usable Check cuvette water blank readings at

cuvettes. [maintenance][wash(F10)] page 2/2 screen and replace or
wash cuvettes exceeding judgement value.
E6100 Not enough numbers of Check cuvette water blank readings at

usable cuvettes to start a [maintenance][wash(F10)] page 2/2 screen and replace or
run. wash cuvettes exceeding judgement value.
E6101 Insufficient reagent to Check the reagent volume and exchange it with a new
perform the run. bottle.
E6120 Standard has been set for Check [calibration][calibration (F9)] parameter settings and
“factor” assay. ensure that no standard value have been set for ‘factor’
assays.
E6121 Found calibrators other This is a warning only and calibration will be performed.
than S2. as blank confirm the calibration type and selection of blank
measurement is set to measurement in screen ‘calibration F9 and checks F10 in
enable reagent blank as job menu calibration F7
S1, only S2 can be used
for calibration.
E6122 Found series dilution

calibration. As blank
measurement is set to
enable reagent blank as
S1, only S2 can be used
for calibration.
E6201 RCU bottle #1: bottle Check label on bottle to ensure it is free from any damage
barcode is not usable. and is clearly displayed in the RCU slot. Check label is a
current Randox barcode.
E6202 RCU bottle #2: bottle See previous entry

barcode is not usable.
E6239 RCU bottle #39 : bottle See previous entry


E6301 RCU bottle #1 : bottle Barcode has already been used in this analyser.use another
barcode has already been bottle/barcode
assigned.

+44 (0) 28 9445 1070

barcode has already been
assigned.

assigned.

assigned.
E6401 RCU bottle #1 : reagent Check reagent is registered in [system

code is not registered. parameters][system(F9)] screen
E6402 RCU bottle #2 : reagent See previous entry

code is not registered.


E6500 The process has been Contact RX support.

interrupted due to
mechanical interference.
E6501 Automatic gain adjustment Check the halogen lamp. Re-perform automatic gain
failed. adjustment. If fault returns contact a service engineer.
E7001 Existing order for a sample Check [run monitor][test select(F10] screen to ensure
has been over written with samples have correct test selection. Repeat affected
order from host sample sample if necessary
E7002 Communication error Check host connection and resend host order list
occurred during order
reception from host.
E7003 Communication error Check host connection and resend results to host
occurred during result
transmission to host.
E7004 Received order with short Ensure sufficient reagents registered on board to perform
reagent received from host test selection
host.
E7005 Sample number with Enter valid sample number. Inform personnel responsible for
invalid character received host data entry information.
from host and discarded.
E7006 Failed to allocate memory Check data from host. Restart analyser and PC and repeat
for result transmission. affected samples
E7007 Host transmission retry Host communication set up is incorrect. check settings on
time has expired the system parameters screen.
E7008 Failed to allocate memory Check the data from the host.
for order acquire. Restart analyser and PC and repeat affected samples
E7010 Sample number with Sample number has been deleted. Inform personnel
invalid character received responsible for host data entry information.
from host and discarded.

+44 (0) 28 9445 1070
E7011 Failed to allocate memory

when acquiring QC data.
E7030 Failed to read serum Failed to load serum indicies file. Parameter setting file is
indicies setting file. missing or corrupted. Contact RX support.
E7051 Received more orders Please reduce number of orders.

from host than the analyser
can handle.
E7075 No valid calibration curve Valid calibration curves are not present for the reagent lots
for reagent lots on RCU. currently on RCU. Check the reagent lot numbers on RCU
and perform a calibration if necessary.
8. 2. 2 UNIT ERRORS
8. 2. 2. 1 RPT ROTATION

CODE
E0101 Unused
E0102 Reagent pipette rotation origin sensor is on after Check unit is free to move within its
rotation from origin normal operational range.
Re initialize analyser.If fault returns
contact RX support
E0103 Reagent pipette rotation origin sensor is on Check unit is free to move within its
before initiation of rotation command back to its normal operational range.
origin Re initialize analyser.If fault returns
contact RX support
E0104 Reagent pipette rotation sensor is off after Check unit is free to move within its
returning to its origin normal operational range.
Re Initialize analyser.If fault returns
contact RX support
E0105 Not used
E0106 Reagent pipette up origin sensor is off at Check unit is free to move within its
initiation of rotation command normal operational range.
contact RX support
E0156 Reagent pipette up origin sensor is off at Check unit is free to move within its
initiation of rotation command normal operational range.
(while not at trough or RCU position) Re initialize analyser.If fault returns
contact RX support

+44 (0) 28 9445 1070
8. 2. 2. 2 RPT VERTICAL MOVEMENT (ORIGIN RPT UPPER LIMIT)

CODE
E0201 Reagent pipette, up origin sensor, is off before Check unit is free to move within its
descent normal operational range.
contact RX support
E0202 Reagent pipette, up origin sensor, is still on after Check unit is free to move within its
contact RX support
E0203 Reagent pipette, ascent to origin sensor, is off Check unit is free to move within its
before ascent normal operational range. Re initialize
analyser.If fault returns contact RX
support
E0204 Reagent pipette, ascent to origin sensor, is on Check unit is free to move within its
after ascent normal operational range.
Re initialize analyser.if fault returns
contact RX support
E0205 Reagent pipette origin sensor is off at the Check unit is free to move within its
initiation of movement command (from a position normal operational range.
other than its origin) Re initialize analyser.if fault returns
contact RX support
E0206 IRU safety sensor is off at reagent pipette Check unit is free to move within its
movement command normal operational range.
contact RX support
E0207 RPT ascend/descend; RPT safety sensor Check unit is free to move within its
(RPTR_TS) is off. normal operational range.
contact RX support
E0251 Reagent pipette up position sensor is off at Check unit is free to move within its
initiation of reagent pipette downward command normal operational range.
E0253 Reagent pipette up position sensor is on at contact RX support
initiation of reagent pipette upward command.
E0255 Reagent pipette up sensor is on at initiation of

reagent pipette up or down command (from a
position other than its origin)
E0257 RPT safety sensor is off.

+44 (0) 28 9445 1070
E0275 Reagent pipette crash detection sensor is on Clean the pipette with
before reagent pipette has reached the bottom of mediswab.Check that reagent pipette
the RCU detection mechanism is not jammed
(the pipette should move up and down
freely).Move the pipette a few mm by
hand, while holding the pipette arm).
Re Initialize,If fault returns contact RX
support
E0276 Reagent pipette cannot detect RCU liquid level Visually check liquid levels within the
reagent bottles inside the RCU. Re
initialize the analyser. If fault persists
contact RX support
E0277 Not used
E0278 Reagent pipette hardware is functioning Re initialize the analyser. If fault

abnormally persists contact RX support
E0279 RPT liquid level detection at RCU; Liquid level is Visually check liquid levels within the
not detected. reagent bottles inside the RCU. Re
initialize analyser.if fault persists
contact RX support
E0280 Not enough wash solution for RPT special wash Not enough wash solution left in the
reagent bottle. Exchange the bottle or
fill with wash buffer, then retry the
wash.

+44 (0) 28 9445 1070
8. 2. 2. 3 RPT (ORIGIN: UPPER LIMIT OF SYRINGE)

CODE
E0301 Reagent syringe pump origin sensor is off at

initiation of aspiration command.
E0302 Reagent pump origin sensor is still on although Check unit is free to move within its
RPP has left its origin normal operational range.
E0303 Reagent pump origin sensor is on before contact RX support
dispensation command
E0304 Reagent pump origin sensor is still off although

reagent pump has returned to its origin
E0305 Reagent pump origin sensor is not on at initiation

of reagent pump movement (while reagent pump
is not at its origin)
E0351 Reagent pump origin sensor is off at initiation of

aspiration command
E0353 Reagent pump origin sensor is on at initiation of

dispensation command
E0355 Reagent syringe pump origin sensor is off at

initiation of aspiration.
8. 2. 2. 4 SPT ROTATION

CODE
E0401 Not used
E0402 Sample pipette origin rotation sensor is still on Check unit is free to move within its
although the pipette has left its origin normal operational range.
contact RX support
E0403 Sample pipette origin rotation sensor is on before Check unit is free to move within its
rotation to its origin normal operational range.
contact RX support
E0404 Sample pipette origin rotation sensor is still off Check unit is free to move within its
although the pipette has returned to its origin normal operational range.
contact RX support
E0405 Not used

+44 (0) 28 9445 1070
E0406 Sample pipette origin rotation sensor is off at Check unit is free to move within its
initiation of pipette rotation command normal operational range.
contact RX support
E0456 Sample pipette origin sensor is off at initiation of Check unit is free to move within its
pipette rotation command normal operational range.
contact RX support
8. 2. 2. 5 SPT UP-AND-DOWN MOVEMENT

CODE
E0501 Sample pipette up origin sensor is off at initiation Check unit is free to move within its
of pipette descent from origin command normal operational range.
contact RX support
E0502 Sample pipette up origin sensor is on after pipette Check unit is free to move within its
contact RX support
E0503 Sample pipette up sensor is on at initiation of Check unit is free to move within its
pipette return to origin command normal operational range.
contact RX support
E0504 Sample pipette up origin sensor is off although the Check unit is free to move within its
pipette has returned to its origin normal operational range.
contact RX support
E0505 Sample pipette up origin sensor is off at initiation Check unit is free to move within its
of pipette movement (the pipette is not at its origin) normal operational range.
contact RX support
E0506 The IRU safety sensor is on at initiation of sample Check unit is free to move within its
pipette movement normal operational range.
contact RX support
E0507 SPT ascend/descend; SPT safety sensor

(SPTR_TS) is off.

+44 (0) 28 9445 1070
E0551 Sample pipette position sensor is off at initiation of Check unit is free to move within its
pipette downward movement normal operational range.
contact RX support
upward movement normal operational range.
contact RX support
pipette movement (the pipette is not at its origin) normal operational range.
contact RX support
E0557 SPT ascend/descend; SPT safety sensor Check unit is free to move within its
(SPTR_TS) is off. (ASP position) normal operational range.
contact RX support
E0575 Sample pipette crash sensor is on but the pipette Clean the pipette with mediswab and
is not at the bottom of the asp gently check free vertical movement
of pipette.There should be a few mm.
of movement up and down.Re
initialize the instrument.If fault returns
contact a service engineer giving
details
E0576 Sample pipette cannot detect the liquid level at Check sample levels in ASP. Check
ASP ASP positions.
If sample levels are normal (the cup
is not empty) re initialize. If fault
returns contact a service engineer.
E0577 Not used
E0578 Sample pipette crash sensor is on but the pipette Clean the pipette with mediswab and
has not reached the bottom of the cuvette gently check free vertical movement
of pipette.(there should be a few mm.
of movement up and down).Re
initialize the instrument.If fault returns
contact a service engineer giving
details
E0579 Sample pipette cannot detect liquid level at IRU Check for liquid in cuvette.Re
initialize If fault persists contact
service engineer
E0580 Not used

+44 (0) 28 9445 1070
E0581 Sample pipette liquid level hardware is abnormal Check ASP position. Check sample
at ASP levels in ASP.
If sample levels are normal (the cup
is not empty) Check for free vertical
pipette movement as for error E 0575
Re initialize.If fault returns contact a
service engineer
E0582 Sample pipette liquid level hardware is abnormal Check sample levels in cuvette.
at IRU If sample levels are normal (the cup
is not empty) Check for free vertical
pipette movement as for error E 0575
contact RX support
E0583 SPT liquid level detection at ASP; liquid level not Check sample levels in ASP.
detected. If sample levels are normal (the cup
is not empty) Re initialize.If fault
returns contact a service engineer.
8. 2. 2. 6 SPT PUMP (ORIGIN: UPPER LIMIT OF SYRINGE)

CODE
E0601 Sample syringe sensor is off at initiation of Re initialize analyser.If fault returns
aspiration instruction contact RX support
E0602 Sample syringe sensor is still on after the syringe Re initialize analyser.If fault returns
has left its origin contact RX support
E0603 Sample syringe sensor is on before iniation of Re initialize analyser.If fault returns
syringe movement command contact RX support
E0604 Sample syringe sensor is still on after syringe hs Re initialize analyser.If fault returns
returned to its origin contact RX support
E0605 Sample syringe sensor is off at initiation of syringe Re initialize analyser.If fault returns
movement command (the syringe is not at its contact RX support
origin)
E0651 Sample syringe sensor is off before aspiration (at Re initialize analyser.If fault returns
trough or asp position) contact RX support
E0653 Sample syringe sensor is on before dispensation Re initialize analyser.If fault returns
contact RX support
(at trough or ASP)

+44 (0) 28 9445 1070
8. 2. 2. 7 MIX-1 ROTATION

CODE
E0706 Mixer 1 origin sensor is on at initiation of stirring Check mixer is free to move within its
paddle rotation command normal operational range. Re
initialize analyser.If fault returns
contact RX support
8. 2. 2. 8 MIX-1 UP-AND-DOWN MOVEMENT

CODE
E0801 Mixer 1 up origin sensor is off at initiation of Check mixer is free to move within its
normal operational range. Re
descent command
contact RX support
E0802 Mixer 1 up origin sensor is still on although mixer 1 Check mixer is free to move within its
has left its origin normal operational range. Re
contact RX support
E0803 Mixer 1 up origin sensor is on at initiation of return Check mixer is free to move within its
to origin command normal operational range. Re
contact RX support
E0804 Mixer 1 up origin sensor is still off although the Check mixer is free to move within its
mixer has returned to its origin normal operational range. Re
contact RX support
E0805 At the initiation of movement the mixer 1 origin Check mixer is free to move within its
sensor is on although the mixer is not at its origin normal operational range.
point
E0806 The IRU safety sensor is off at the initiation of Check mixer is free to move within its
mixer 1 movement normal operational range. Re
contact RX support

+44 (0) 28 9445 1070
8. 2. 2. 9 MIX-2 ROTATION

CODE
E0906 Mixer 2 origin sensor is on at initiation of mixer Check mixer is free to move within its
paddle rotation command normal operational range. Re
contact RX support
8. 2. 2. 10 MIX-2 UP-AND-DOWN MOVEMENT

CODE
E1001 Mixer 2 up origin sensor is off at initiation of Check mixer is free to move within its
descent command normal operational range. Re
contact RX support
E1002 Mixer 2 up origin sensor is still on although mixer 2 Check mixer is free to move within its
has left its origin normal operational range. Re
contact RX support
E1003 Mixer 2 up origin sensor is on at initiation of return Check mixer is free to move within its
to origin command normal operational range. Re
contact RX support
E1004 Mixer 2 up origin sensor is still off although the Check mixer is free to move within its
mixer has returned to its origin normal operational range. Re
contact RX support
E1005 At the initiation of movement the mixer 2 origin Check mixer is free to move within its
sensor is on although the mixer is not at its origin normal operational range. Re
point initialize analyser.If fault returns
contact RX support
E1006 The IRU safety sensor is off at the initiation of Check mixer and IRU are free to
mixer 2 movement move within their normal operational
ranges. Re initialize analyser.If fault
returns contact RX support

+44 (0) 28 9445 1070
8. 2. 2. 11 WU UP-AND-DOWN MOVEMENT

CODE
E1101 Wash unit origin sensor is off at initiation of Check wash unit is free to move
descent command within its normal operational range.
contact RX support
E1102 Wash unit origin sensor is still on although the Check wash unit is free to move
wash unit has left its origin within its normal operational range.
contact RX support
E1103 Wash unit origin sensor is on at initiation of wash Check wash unit is free to move
unit return to origin command within its normal operational range.
contact RX support
E1104 Wash unit origin sensor is still off although the Check wash unit is free to move
within its normal operational range.
wash unit has returned to its origin
E1105 WU ascend/descend at off-origin; WU origin contact RX support
sensor (wu_zero) should be off before action but

is not.
E1106 The IRU safety sensor is off at initiation of wash Check wash unit and IRU are free to
unit movement move within their normal operational
ranges.
contact RX support
8. 2. 2. 12 WU PUMP (ORIGIN: UPPER LIMIT OF SYRINGE)

CODE
E1201 WPP aspiration; WPP origin sensor (WPP_zero) is Retry the aspiration and contact RX
off before aspiration. support if problem persists.
E1202 Wash pump syringe origin sensor is still on Re initialize analyser.If fault returns
although the wash pump has left its origin contact RX support
E1203 Wash pump syringe origin sensor is on before Re initialize analyser.If fault returns
initiation of wash pump movement command (from contact RX support
fully dispensed position)
E1204 Wash pump syringe origin sensor is off although Re initialize analyser.If fault returns
the unit has returned to its origin contact RX support
E1205 Wash pump syringe origin sensor is on at initiation Re initialize analyser.If fault returns
of wash pump movement although the unit is not contact RX support
at its origin
E1206 WU overflow (wu_over=1) (during prime) Reprime analyser and contact RX

support if problem persists.

+44 (0) 28 9445 1070
E1256 WU overflowing during run. Reprime analyser and contact RX

E1276 WU overflow (WU_OVER=1) Reprime analyser and contact RX

8. 2. 2. 13 IRU

CODE
E1301 Not used
E1302 IRU origin sensor is still on although the IRU has Re initialize analyser.If fault returns
left its origin contact RX support
E1303 Not used
E1304 IRU origin sensor is off although the IRU has Re initialize analyser.If fault returns
returned to its origin contact RX support
E1305 Not used
E1306 Sample pipette rotation origin sensor is on at Check sample pipette is free to move
initiation of iru rotation command within its normal operational range.
contact RX support
E1307 Reagent pipette rotation origin sensor is on at Check reagent pipette is free to move
initiation of IRU rotation command within its normal operational range.
contact RX support
E1308 Wash unit origin sensor is on at initiation of IRU Check wash unit is free to move
command within its normal operational range.
contact RX support
E1309 At cuvette water placement and filter rinsing;

RPTU origin sensor is off.
E1310 At cuvette water placement and filter rinsing;

SPTU origin sensor is off.

+44 (0) 28 9445 1070
8. 2. 2. 14 RCU
CODE
E1401 Not used
E1402 RCU origin sensor is still on although the RCU has Check RCU is free to move within its
left its origin normal operational range. Re
contact RX support
E1403 Not used
E1404 RCU origin sensor is on at initiaton of return to Check RCU is free to move within its
origin command normal operational range. Re
contact RX support
E1405 Not used
E1406 Reagent pipette up origin sensor is off at initiation Check RCU is free to move within its
of RCU rotation command normal operational range. Re
contact RX support
E1454 RCU origin sensor is off although the RCU has Check RCU is free to move within its
returned to its origin normal operational range. Re
contact RX support
8. 2. 2. 15 FLT

CODE
E1501 Not used
E1502 Filter wheel origin sensor is on although the filter Contact RX support
wheel has left its origin
E1503 Not used
E1504 Filter wheel origin sensor is off although the filter Contact RX support
wheel has returned to its origin
E1505 Not used
E1506 Not used
E1507 Not used
E1508 Automatic gain adjustment abnormal Perform manual DTR adjustment at

the maintenance performance
screen.
If fault persists take note of the
detector performance values. Contact
RX support

+44 (0) 28 9445 1070
8. 2. 2. 16 ASP

CODE
E1601 Not defined.
E1602 ASP rotation from origin; origin sensor (ASP-zero) Contact RX support.
is on after rotation.
E1603 Not defined.
E1604 ASP rotation to origin; origin sensor (ASP-zero) is Contact RX support.

not on after rotation.
E1605 Not defined.
E1606 ASP rotation from origin; sptu origin sensor (SPTU- Contact RX support.
zero) is on after rotation.
E1654 ASP rotation to origin; origin sensor (ASP_zero) is Contact RX support.

not on after rotation.
8. 2. 2. 17 ISE

CODE
E1775 ISE; Serum sample error Refer to chapter 9
E1776 ISE; Urine sample error Refer to chapter 9
E1777 ISE; no data Refer to chapter 9
E1780 No acknowledgement from the ISE module for Broken communication or poor
‘electrode exchange’ command. contact at connectors. If fault returns
contact RX support.
E1781 No acknowledgement from the ISE module for
‘prime’ command.
E1782 No acknowledgement from the ISE module for

‘cleaning’ command.

+44 (0) 28 9445 1070
8. 2. 2. 18 TANK (DURING PRIME OPERATION)
ERROR
MESSAGE ACTION
CODE
E2605 Wash solution 3 is low. Refill tank and prime analyser.
E2606 Purified water supply is low.
E2607 Wash solution 1 is low.
E2608 Wash solution 2 is low.
E2609 Waste tank 1 is full to capacity. Empty tank 1.
E2610 Waste tank 2 is full to capacity. Empty tank 2.
8. 2. 2. 19 TANK (DURING RUNNING OPERATION)
ERROR
MESSAGE ACTION
CODE
E2675 Wash solution 3 is low Refill tank and prime analyser
E2676 Purified water supply is low
E2677 Wash solution 1 is low
E2678 Wash solution 2 is low
E2679 Waste tank 1 is full to capacity Empty tank 1
E2680 Waste tank 2 is full to capacity Empty tank 2
8. 2. 2. 20 COVER AND WASTE LIQUID CHAMBER

CODE
E2701 Lid for ASP is open. Secure ASP lid.
E2702 Lid for RCU is open. Secure RCU lid.
E2703 Waste chamber over flow Contact RX support.
E2775 Not used

+44 (0) 28 9445 1070
8. 2. 2. 21 IRU AND RCU

CODE
E3051 IRU temperature lower than 35 degrees C. Check temperature readings on
E3052 IRU temperature higher than 39 degrees C. Maintenance/Performance screen. Allow
E3053 RCU temperature higher than 15 degree. sufficient time after switch on to come to
temperature. If problem persists contact
RX support.
8. 2. 2. 22 BARCODE READER

CODE
E5001 Sample barcode reader; initialization error.
E5002 Reagent barcode reader; initialization error.
E5075 Unable to read sample barcode Clean barcode window and check
barcode label.
Please Note:
EXX01: means that the origin sensor is off at the time of initiation of movement from
the origin.
EXX02: means that the origin sensor is still on after departure from the origin. This is
effective at the time of initialisation only.
EXX03: means that the origin sensor is on before initiation of movement for returning
the origin.
EXX04: means that the origin sensor is still off after return to the origin.
EXX05: means that the origin sensor is not on at the time of initiation of movement
from the point other than the origin.

+44 (0) 28 9445 1070
SECTION 9 ISE USE AND MAINTENANCE Version 2.0 Rev September 2009
SECTION 9
ISE USE AND MAINTENANCE

+44 (0) 28 9445 1070
9.1 GENERAL INFORMATION FOR ISE MEASUREMENT

1. Electrodes are marked with an ‘INSTALL BY’ date. The electrode is warranted for
up to 10,000 samples.
2. Once installed, electrodes require a flush with Calibrant A every 30 minutes,
therefore the analyser should be kept in SLEEP mode even when not in use.
3. A purge procedure should be performed before turning off the power to the
analyser. If fluid is left in the unit it could result in potassium measurement drift.
The purge procedure may be performed using the Electrode Exchange command.
(see Section 9. 4. 13“Exchange Of ISE Electrodes” on page 283).
4. A 2-point calibration of the ISE module should be performed daily prior to running
samples. ISE cleaning is required at the end of each day when running more than
50 samples a day.
5. Do not clean the electrode more than recommended as small levels of protein
build up help stabilise the measurements. Wash solution can affect electrode
performance.
6. High measurements for sodium only may be caused by a bubble in the fluid line.
Perform an ISE prime (SEQUENCE (F9) in the MAINTENANCE menu) and then
calibrate the ISE. If problems persist repeat ISE PRIME three times.
7. An acceptable variation of calibration results between two consecutive calibration
measurements is 2.0.
8. Calibrant A, B and Wash solution should be stored in a dark place at room
temperature.
9. 1. 1 ISE UNIT
The ISE unit consists of an ISE module, ion exchange electrode and two pumps for
supply and waste.
ISE module Consists of electrodes (Na, K, Cl and Reference) and pumps.
RS232C port used for communication with the analyser.
Ion Electrode Consists of Na, K, Cl and Reference electrodes.
Supply Pump Supplies Calibrant A to ISE module.
Waste Pump Drains liquid from ISE module.
Waste is transferred to the external high concentration waste tank.

+44 (0) 28 9445 1070
9.2 ISE THEORY

Electrolyte measurements in blood samples were traditionally performed using flame
photometry, in which a sample, diluted with a known concentration of a reference ion
(usually lithium or caesium), is aerosolised and passes through a flame which excites
the cations. The cations emit the energy as light of different frequencies, the
amplitude of emission is proportional to the ion concentration in the sample. The
development of selective organic compounds for sodium, potassium, chloride and
other electrolytes has permitted the development of sensors capable of directly
measuring biological fluids throughout the physiological range. These sensors are
known as Ion Selective Electrodes or ISEs.
The RX daytona electrolyte measurement system measures sodium, potassium and

chloride in biological fluids, using ion selective electrode technology. A diagram of the
electrode measurement system is shown below.
Figure 9.1 Electrode Measurement Diagram
The flow-through sodium electrode uses selective membrane tubing, specially

formulated to be permeable to sodium ions. The potassium and chloride electrodes
employ similar designs with appropriate selective membrane materials. The potential

+44 (0) 28 9445 1070
of each electrode is measured in relation to a fixed, stable voltage established by the

double-junction silver/silver chloride reference electrode. An ion selective electrode
develops a voltage that varies with the concentration of the ion to which it responds.
The relationship between the voltage developed and the concentration of the sensed
ion is logarithmic, as expressed by the Nernst equation:
where E = The potential of the electrode sample solution

E° = The potential developed under standard conditions
RT/nF = A temperature dependent ‘constant’, termed the slope
Log = Base ten logarithm function
µ = Activity coefficient of the measured ion in the solution
C = Concentration of the measured ion in the solution
A comparative method of measurement is utilised. First, the ISE module measures

the potentials developed when the sample is positioned in the electrodes. Calibrant A
is then positioned in the electrodes. The difference in the two potentials is related
logarithmically to the concentration of measured ions in the sample divided by their
respective concentrations in the calibrant solution. As the difference in potentials and
the concentration of the sodium, potassium or other ions in the calibrant solution are
known, the concentration of the ions in the sample solution can be derived from the
Nernst equation which is rewritten as follows:
E - E° = S log ( Cx / Cs) or Cx = Cs x 10 [(E - E°) / S]
where E = ISE potential developed in sample solution

E° = ISE potential developed in Calibrant A solution
S = Electrode slope calculated during calibration with Cal A
and B.
Cx = Concentration of ion in the sample
Cs = Concentration of ion in the Calibrant solution
‘S’, the slope, is determined during the calibration using Calibrant A and B, which
have known levels of sodium, potassium and chloride.

+44 (0) 28 9445 1070
9.3 ISE TECHNICAL SPECIFICATIONS

Sample Serum, Plasma or Urine (Urine: automatic 1 in 10 dilution)
Sample size 70ml serum; (70ml X 3) + 50ml urine
Reproducibility Maximum imprecision Typical carry over, % serum
Serum (within run)

Na CV < 1.5% (100 – 160mmol/L) < 0.5%
K CV < 2% (3.0 – 6.0mmol/L) < 1.5%
Cl CV < 1.5% (80 – 120mmol/L) < 1.0%
Urine (within run)

Na CV < 5% (20 – 500mmol/L)
K CV < 5% (1 – 500mmol/L)
Cl CV < 5% (20 – 500mmol/L)
Serum (between day)

Na CV < 2% (100 – 160mmol/L)
K CV < 2.3% (3.0 – 6.0mmol/L) < 1.5%
Cl CV < 2.3% (80 – 120mmol/L) < 1.0%
Analysis Time Serum – 30 seconds, including one point calibration

Urine - 100 seconds, including one point calibration
Throughput Serum – 270 tests per hour, 90 samples per hour
Power 12VDC, 0.6A
Module size 100mm H x 102mm W x 91mm D
Reagents Calibrator A/Calibrator B

Cleaning Solution
Urine Diluent
Max. Temperature 38ºC

+44 (0) 28 9445 1070
9.4 ISE OVERVIEW

9. 4. 1 ISE MODULE
The ISE electrodes are installed as follows:
1. Remove ISE access panel from right side of analyser. (See 2. 2. 10“Electrolyte
Measurement Unit (Ise Option)” on page 37 for location of ISE unit).
The ISE unit is attached to a small, hinged compartment which can be

accessed by pulling the handle outwards. The ISE electrodes are inserted
in the following order:
Figure 9.2 Front View of ISE Unit with Modules Fitted in Sequence .
2. The reference electrode is larger than the others and is inserted first. Remove ISE
Reference module from the protective packaging.
3. Remove the thin plastic insert inside the ISE module.
4. Place the Reference electrode inside the ISE unit by pressing down on the
compression plate.
5. Push the electrode into the required position (as shown above) and release the
compression plate. Ensure it cannot move once the lever is released.
6. Analyte electrodes for Na, K and Cl are the same size and shape. Connection pins
at the rear of each electrode are different, ensuring that the electrodes are
inserted in the correct order and orientation as shown above.
7. Remove the Chloride electrode from its protective packaging and place in the unit
in the same way as the Reference electrode.
8. Repeat the process for the Potassium electrode followed by the Sodium electrode.

+44 (0) 28 9445 1070
9. Once all four electrodes have been inserted push all three electrodes in
simultaneously to ensure correct alignment. Close the ISE unit and replace the
ISE unit access cover.
10. Once installed, the electrode should be primed and calibrated. (see section 10.3.3
for details).
WARNING: The analyser should only be placed in SLEEP MODE when ISE
electrodes are installed. NEVER switch off the analyser at the mains power
supply when ISE electrodes are installed as CAL A solution is pumped through
to keep the electrodes hydrated and prevent them from drying out. If the
electrodes dry out, the recommended expiry date is invalid. Ensure that there is
sufficient CAL A on board to hydrate the ISE electrodes.
9. 4. 2 DESCRIPTION OF ISE REAGENTS

The following reagents are required for ISE operation.
Calibrator A
Used as a wash solution during calibration and to prime the ISE electrodes. The Cal A
bag is located in a dedicated compartment with an access door on the top section of
the analyser (see overleaf).
PLEASE NOTE: When the analyser is switched on from power off, Cal A is pumped
through the ISE unit for approximately 1 minute to ensure it is fully primed. While the
analyser is switched on 120μl Cal A is pumped through the electrodes every 30
minutes to prevent drying out.
Calibrator B
Used for ISE calibration (2 point calibration). During calibration Cal B is aspirated
from a sample cup on the analyser at position 18 on the sample tray. Calibration
should be performed at least once a day or every 8 hours, depending upon the
laboratory schedule.
Cal B should only be placed on the analyser immediately before use to prevent
variations in value due to evaporation.

+44 (0) 28 9445 1070
Figure 9.3 Location of Calibrator A Bag
Cleaning Solution
Used to clean the ISE electrodes. Cleaning should be performed once at the end of
the day to prevent protein build up or at 8-hour intervals if the ISE module performs
more than 50 samples per day. During cleaning 600µl of cleaning solution should be
placed in a sample cup at position19 in the sample carousel. After cleaning, the
analyser should remain on standby for 30 minutes to stabilise the membrane.
Urine Diluent
Urine samples are automatically diluted by a factor of 10 with urine diluent prior to
measurement. Urine diluent is located in a reagent position in the RCU tray and
should be registered as a reagent in the System Parameters/System (F9) screen. A
volume of 315ml is dispensed into a cuvette in the IRU where the dilution takes place.
The diluted sample is then dispensed into the ISE module.

+44 (0) 28 9445 1070
9. 4. 3 STORAGE AND USE OF ISE REAGENTS

All ISE reagents should be stored in a cool dark environment. Cal B and ISE Cleaning
Solution should be dispensed from their containers just prior to use and once used
should be disposed of as evaporation will alter the concentration of the solutions. The
Cal A bag has been designed to minimise evaporation and condensation effects.
Reagents must never be used that have exceeded their expiry date.
9. 4. 4 ISE UNIT POWER OFF

It is recommended that the analyser is placed into sleep mode only as Cal A solution
is pumped through the electrodes every 30 minutes to keep them saturated (see
section 3. 3. 4“Analyser Shut Down” on page 106. It is not recommended to switch off
the analyser power for any extended periods. If the electrodes are left for 2 hours or
more without regular Cal A flow then it is possible for Na+ ions to pass from the
reference electrode into the Na electrode and affect sodium measurement.
PLEASE NOTE: If the ISE unit is switched off for more than 2 hours the ISE
Module storage procedure should be followed to ensure correct storage of the
electrodes.
9. 4. 5 ISE MODULE STORAGE

If the ISE module is switched off for over 2 hours perform the following steps to
prevent the electrodes from drying out.
1. Carry out ISE Prime10 times (MAINTENANCE/SEQUENCE(F9) screen).
2. Remove all electrodes from ISE unit. Place Na, Cl and Ref electrodes into
individual sealed bags. Remove some Cal A from the Cal A bag and inject Cal A
into the lumen of the K electrode and seal both sides of electrode with cellophane
to ensure Cal A is retained. Place K electrode into a sealed bag.
3. Remove Cal A bag from the analyser and discard if storage period is greater than
the on-board stability.
9. 4. 6 LOADING CALIBRATOR A
Calibrator A is loaded on the analyser as follows:
1. Loosen the M3 screw and pull the plastic clip from the top right of the analyser to
remove the Calibrator A access panel (see Figure 9.6“Access to ISE Unit” on
page 282).

+44 (0) 28 9445 1070
2. Remove tube and attached lid from existing Cal A bag.

3. Place the new Cal A bag into the Cal A section of the ISE unit.
4. Reattach the tube, ensuring that the tube is touching the bottom of the bag.
5. Reset the working hour counter for Calibrant A in the MAINTENANCE/WASH
(F10) screen.
6. Perform ISE prime (MAINTENANCE/SEQUENCE (F9) 10 times to ensure that the
new Cal A has been thoroughly primed through the unit.
PLEASE NOTE: Do NOT mix old Cal A solution with new solution. After
changing Cal A solution prime the ISE 10 times.
9. 4. 7 ISE OPERATING CYCLES

The electrolyte measurement system performs the following cycles.
9. 4. 7. 1 SERUM SAMPLE CYCLE

Cal A is pumped out of the electrodes and sample is pumped in from the sample port.
The module acquires a sample reading, pumps Cal A to flush the electrodes, and
then acquires a Cal A reading.
9. 4. 7. 2 URINE SAMPLE CYCLE

Cal A is pumped out of the electrodes, and a diluted urine sample is pumped from a
reaction cuvette in through the sample port. Module acquires sample reading, pumps
Cal A to flush the electrodes and acquires a Cal A reading. The software then
calculates the patient result accounting for the 10 fold dilution.
9. 4. 7. 3 CALIBRATION CYCLE
Cal A is pumped from the electrodes. Module pumps Cal B from sample port to the
ion selective electrodes, acquires Cal B reading, pumps Cal A to flush the ion
selective electrodes, and then acquires a Cal A reading. The software calculates the
slope (S) from the two readings.
9. 4. 7. 4 PRIME CYCLE
Purges air from the electrodes by pumping Calibrator A from the container until the
lumens of all electrodes are filled. Several cycles may be required to fully purge air
from the fluid lines.

+44 (0) 28 9445 1070
9. 4. 7. 5 ELECTRODE EXCHANGE
Purges all fluid from the ISE module to allow removal of electrodes without fluid spills.
The automatic sipping (Stand-by cycle) is disabled.
9. 4. 7. 6 ISE CLEANING CYCLE

Pumps cleaning solution from the sample port into the ISE electrode until cleaning is
complete. Pumps Cal A to flush ion selective electrodes and then acquires a Cal A
reading.
9. 4. 7. 7 STAND-BY CYCLE
Pumps 120µl of Cal A into the lumen of the ISE electrodes every 30 minutes to keep
electrodes saturated. If the power supply is switched off the analyser will be unable to
perform this cycle and the electrodes may dry out. If the electrodes dry out the
recommended expiry date of the electrodes will be affected.
9. 4. 8 ISE PARAMETERS SCREEN

Various functions relating to the ISE unit can be viewed and altered from the SYSTEM
PARAMETERS/ISE (F11) screen.
Please Note: This screen is only available on analysers that have an integrated ISE
unit installed.
Figure 9.4 ISE Parameters Screen

+44 (0) 28 9445 1070
Reagent Code for Urine Diluent

Enter the urine diluent code as outlined below.
1. Ensure a urine diluent has been registered as a reagent code (see Section 3. 2. 2.
2“Registration of Open Channel Barcoded Bottles” on page 59), and is present on
board the analyser as a reagent visible in the RUN MONITOR/INVENTORY (F11)
screen.
2. Go to SYSTEM PARAMETERS/ISE (F11) screen (see Figure 9.4“ISE Parameters
Screen” on page 277).
3. Click on the ‘URINE DILUENT FOR ISE’ field. Press the spacebar and select the
ISE diluent (code [ISEDIL) by double clicking on the required field.
4. Click SAVE to store the settings.
ISE Calibration
The results of the last ISE calibration along with error codes are displayed in this field.
Volume Adjustment for ISE

This is not accessible by the user therefore cannot be altered.
Instrument Factor for ISE

Linear correction factors for ISE and ISE diluent can be entered to adjust for small
variations between different analyser systems.
9. 4. 9 ISE PARAMETERS SCREEN -2

The normal range of ISE measurements can be set on Page 2 of 2 on the ISE
parameters screen.

+44 (0) 28 9445 1070
Figure 9.5 ISE Chemistry Parameters Screen
ISE - undiluted ISE (D) - diluted

measurement measurement
SERUM URINE
After normal range values have been entered click SAVE.
9. 4. 10 SAMPLE PROCESSING
1. Sample is dispensed into the ISE module sample port.
2. Sample is pumped into the electrodes.
3. Sample equilibration and reading occurs over a 7 second period.
4. Sample is pumped out.
5. Calibrator A is pumped into the electrode module to flush the channel.
6. Calibrator A equilibration and reading occurs over a 7 second period.
7. Results are transmitted to the host analyser.
8. ISE module is now ready for the next cycle.
When the analyser is in STANDBY mode Cal A is pumped into the electrodes every
30 mins to prevent them from drying out.
Each sample requires approximately 200µl of Calibrator A solution for flushing the
electrodes and obtaining a Cal A measurement. A volume of 120µl is used for each
flush.

+44 (0) 28 9445 1070
9. 4. 11 ISE CALIBRATION
ISE calibration must be carried out before ISE measurement is performed in the
following cases:-
1. ISE unit has been switched off.
2. Eight hours have passed since the last ISE calibration.
3. Environmental temperature has changed by more than 8ºC since last ISE
calibration.
It is recommended that ISE calibration is carried out at the beginning of each day
before measurement commences. If more than 50 samples are run per day, cleaning
and calibration must be performed every 8 hours. 120µl volume of Calibrator B is
used during ISE calibration.
During ISE calibration, electrode calibration slopes are transmitted by the module for
QC purposes and may be used by the operator to diagnose module performance.
The slope is defined as:
where CA = Calibration A concentration in mmol/L

CB = Calibration B concentration in mmol/L
EA = ISE potential developed by Cal A solution in mV
EB = ISE potential developed by Cal B solution in mV
The module’s electronic processor checks the slope and an error code will be
generated if they are outside the required range. Typical slopes are approximately
55mV/decade for Na+ and K+ and approximately 45mV/decade for Cl-. Acceptable
slope limits are:

+44 (0) 28 9445 1070
Analyte Slope (mV/decade) Range (mmol/l)
Na+ 50 – 66 Serum 20 – 200 Urine 20 - 1000
K+ 50 – 63 Serum 0.2 – 20.0 Urine 1 - 50
Cl- 40 - 59 Serum 25 – 200 Urine 20 - 500
Procedure
ISE calibration is performed from the Maintenance/Sequence (F9) screen.
1. Prime the analyser at least once using the ‘PRIME SEQUENCE’ option on the
System Parameters/Sequence (F9) screen.
2. If previous ISE cleaning has been performed, condition electrodes as described in
section 9. 5. 2“ISE Cleaning” on page 290.
3. Click ‘START’on the ’ISE PRIME’ option and prime ISE 3 times.
4. Click ‘START’ on the ‘ISE CALIBRATION’ option.
5. Place 500µl of Calibrator B in a sample cup at sample position 18 when prompted.
6. Replace ASP lid and select ‘OK’.

7. During calibration an ‘ISE CALIBRATION IN PROGRESS’ message is displayed.
8. Once this message disappears the results of the ISE calibration are automatically
printed (if result printout is enabled) and can be viewed on the SYSTEM
PARAMETERS/ISE (F11) screen.
9. Check that the calibration falls within the acceptable limits and that there are no
error codes (0000 means no error).
10. Repeat ISE calibration until two consecutive measurements display no errors and
the values fall within 2.0 units.

+44 (0) 28 9445 1070
9. 4. 12 REPLACING CALIBRATOR A
Follow the procedure shown below to exchange the ISE Calibrant A bag.
Procedure for exchange

1. Take off the cover from the Cal A tank located on the right side of the upper panel
by removing a M3 screw and a latch (see figure 9.6)
Figure 9.6 Access to ISE Unit
D200-0256
2. Replace Calibrant-A bag, and connect the feed tube into the bag.
3. Go to MAINTENANCE / WASH (F10) in the software screen.
4. Click on the RESTART button adjacent to Calibrant A.

+44 (0) 28 9445 1070
Figure 9.7 Location of Cal A Bag
9. 4. 13 EXCHANGE OF ISE ELECTRODES

Electrodes are marked with an ‘INSTALL-BY’ date and if installed before this date the
electrodes can be used for up to 6 months or 10,000 samples whichever occurs first.
Follow the procedure below to exchange electrodes.
1. Go to Maintenance/Wash (F10) Page 1 of 2.
2. Click on the START button adjacent to ‘ELECTRODE EXCHANGE’.
3. The following screen prompts will appear.
Figure 9.8 Screen Prompt 1 for ISE Exchange
4. Select OK to confirm exchange – the following prompt is displayed until the

analyser is ready for electrode exchange.

+44 (0) 28 9445 1070
When the analyser is ready for electrode exchange the following prompt will appear.
Click on ‘SHUT DOWN’.

1. Once the PC has been shut down, turn off the power to the analyser.
2. Take off the ISE cover on the right side panel of the analyser as shown in Figure
9.11“ISE Electrode Exchange” on page 285.

+44 (0) 28 9445 1070
Figure 9.11 ISE Electrode Exchange
3. Pull open the ISE door using the door knob (Figure 9.11).
4. Press down the compression plate (Figure 9.12) to ease removal of the electrode.
5. Pull out the electrode by twisting in a counter clockwise direction.
6. Insert a new electrode into the same position (see Figure 9.12“Insertion of ISE
Electrodes.” on page 286).
7. Close the ISE unit door until it clicks into position.
8. Replace the ISE cover.
9. Turn on the analyser and PC.
10. If the existing electrodes have been exchanged for new electrodes, reset the
working hours counter of the electrodes in Maintenance/Wash(F10) screen.
11. Perform ’ISE PRIME’ 10 times from the Maintenance/Sequence(F9) screen.
12. Leave the analyser for 15 minutes to allow new ISE electrodes to stabilise before
performing any measurement.
13. Perform ISE Calibration.

+44 (0) 28 9445 1070
Figure 9.12 Insertion of ISE Electrodes.
Electrode
Electrode ISE Unit LED.
handle This is lit red
when power is on
Compression Plate
PLEASE NOTE: Confirm new electrodes have ‘O’ ring firmly fitted and any
tubing is removed from the lumen of the electrode. Perform additional ISE
primes if an acceptable calibration cannot be obtained with the new electrodes
(see section 9.7“ISE TROUBLESHOOTING” on page 295).
9. 4. 14 EXCHANGE OF ISE PUMP CASSETTES

Pump cassettes must be changed at regular intervals to ensure accurate ISE
measurement. To view the pumps exchange time go to MAINTENANCE/
WASH(F10).
1. Detach the Calibrant A bag and prime the ISE 5 times to purge the liquid.
2. Click on SHUTDOWN to switch off the analyser.
3. Remove the right cover of the analyser and pull out the ISE unit.
4. Pull out the two tubes of the pump cassette.

+44 (0) 28 9445 1070
Figure 9.13 Removing ISE Pump Cassette
Do not remove
metal pipe
from tube
Motor shaft
Push this Push this

clip clip
Press both sides of clips with fingers to release

the pump cassette. To fit the pump, push it
towards the shaft and let the clips snap into place.
5. Replace the pump cassette. Both pumps must be replaced when performing this
procedure.
4
3
1 2
Waste
Pump
Supply
Pump
Tube number 1. Supply pump outlet. (connect to sample port of ISE unit).
2. Supply pump inlet (connect to Calibrant A bag)
3. Drain pump outlet (connect to external drain tank)
4. Drain pump inlet (connect to termination port of ISE unit)

+44 (0) 28 9445 1070
6. Attach Calibrant A bag feed tube, turn the analyser power on and prime 10 times.
During priming check that the fluid flows correctly into each tube and that there are
no leakages.
7. Reset the working hours of the pump cassette in the Maintenance/ Wash (F10) /
Page 2 of 2.

+44 (0) 28 9445 1070
9.5 ISE MAINTENANCE

Correct maintenance procedures should be followed to ensure optimal performance
of ISE electrodes.
• When properly maintained, each ISE electrode can analyse up to 10,000 samples.
• Cleaning solution, aspirated from the sample cup in position 19, is used at least
once a day at the end of each day.
• An ISE calibration should be performed every 8 hours.
• If the ISE is running more than 50 samples per day, then the cleaning procedure
should be performed every 8 hours.
• The entire double junction electrode is disposable. The reference electrode is
filled with sufficient KCl to ensure that no refilling of the solution is required
throughout the lifetime of the electrode.
• Electrodes require a Cal A flush every 30 minutes
• Urine samples are automatically diluted by a factor of 10 before measurement.
• The ISE module is not refrigerated. Therefore, the operator must ensure that the
ambient temperature does not exceed 38ºC.
• Sampling port should be kept free from crystalline deposits at all times as these
can adversely affect the results.
9. 5. 1 MAINTENANCE SCHEDULE
The ISE module requires minimal operator maintenance and the only daily
maintenance is the cleaning procedure at the end of each day. Recommendations for
replacement of expendable items are listed below.
Recommended Maintenance/Replacement Intervals

Pump cassette 9 months
Na Electrode 6 months
K electrode 6 months
Cl electrode 6 months
Ref. electrode 6 months
Reagent Refill as necessary

+44 (0) 28 9445 1070
High Volume User

Pump cassette 6 months
Na Electrode 10,000 samples
K electrode 10,000 samples
Cl electrode 10,000 samples
Ref. electrode 10,000 samples
Reagent Refill as necessary
9. 5. 2 ISE CLEANING
ISE unit requires cleaning at least once daily or every 8 hours if the number of
samples measured is greater than 50. It is recommended that the cleaning procedure
is performed at the end of the day as the electrodes must be left to stabilise for 30
minutes after the cleaning procedure. During this 30 min period it is recommended
that the electrodes are ‘conditioned’ by performing ISE measurements on any control
serum. The values of this measurement are not significant. The purpose of the
conditioning is to establish a fine layer of protein over the ISE electrode membranes.
Start ISE cleaning as follows:
1. Go to the SYSTEM PARAMETERS/SEQUENCE (F9) screen.

2. Click on ‘START’ for the ‘ISE CLEANING’ option.
3. Place 600µl of ISE Cleaning solution in a sample cup at position 19 in the sample
tray, when prompted to do so (Figure 9.14“Maintenance Sequence Screen” on
page 291).

+44 (0) 28 9445 1070
Figure 9.14 Maintenance Sequence Screen
4. Replace ASP lid and click ‘OK’.

5. The following pop-up window is displayed while cleaning is in process.
6. When the pop-up window disappears ISE cleaning has been completed.
7. If further measurement is required after cleaning, or system should be placed into
‘Sleep’ mode, ISE unit should be primed 5 times by clicking ‘START’ in the ‘ISE
PRIME’ option.
8. Further measurement should not be performed for 30 minutes after ISE cleaning
to allow the electrodes to stabilise.
9. Perform ISE conditioning if further measurements are required or place the
analyser into sleep mode if appropriate.

+44 (0) 28 9445 1070
ISE Conditioning
1. Load sample positions 1 - 5 with any control serum – the results are not significant
so any control serum may be used.
2. Go to Run Monitor/Test Select (F11)] screen.
3. Select an ISE measurement to be performed as a normal (N) sample on each of
the samples in positions 1 - 5. See Sections 3. 2. 4“Test Selection For Barcoded
Patient Samples” on page 77 & 3. 2. 6“Test Selection For Non-barcoded Patient
Samples” on page 93 for full instructions on test selection for barcoded and non-
barcoded samples.
4. Press START (F1) to commence analysis.
5. Once analysis has been completed remove samples from the sample tray.

+44 (0) 28 9445 1070
9.6 ERROR MESSAGES & ALARM CODES

This section provides a summary of the alarm codes that may appear on screen.
When an error or alarm occurs during operation, a reference can be made to the table
below. Contact RX support for help if required.
ISE UNIT ERROR CODES

E1775 //ISE ISE; Serum sample error
E1776 // ISE; Urine sample error
E1777 // ISE; No data

+44 (0) 28 9445 1070
ISE MODULE ERROR CODES
Measurem
Cause Byte 1 Byte 2 Byte 3 Byte 4 Byte 4
ent Item
Noise or Noise or Drift in Out of

Air for Air for Calibrant- Range for
Sample or Calibrant- A Sample or
Calibrant- A Calibrant-
B B or Urine
No error 0 0 0 0
Na 1 1 1 1
K 2 2 2 2
Noise, Drift or Na, K 3 3 3 3

Out of Range Cl 4 4 4 4
Na, Cl 5 5 5 5
K, Cl 6 6 6 6
Na, K, Cl 7 7 7 7
Air S or B A (Note-1) -- --
(Note-1)
No error 0 0 0 0 K(Note-2)
Na 1 1 1 1 L
K 2 2 2 2 M
Noise,Drift or Na, K 3 3 3 3 N
Out of Range
(Urine) Cl 4 4 4 4 O
Na, Cl 5 5 5 5 P
K, Cl 6 6 6 6 Q
Na, K, Cl 7 7 7 7 R
SPT liquid 9 9 9 7
detection error
SPT 9 9 9 8
malfunction
Communication 9 9 9 9
error
Note-1: “S” = Sample

“A” = Calibrator A
“B” = Calibrator B
Note-2: When there is only a Na Urine error and no out of range error, the error
code is “K”.

+44 (0) 28 9445 1070
9.7 ISE TROUBLESHOOTING

When troubleshooting the RX DAYTONA ISE unit, the following initial checks should
be carried out:
1. Correct electrode installation procedure has been followed.
2. ISE unit is receiving power from the host analyser (check red LED is ON)
3. Equipment is being used by trained personnel in accordance with manufacturers
recommendations.
4. System maintenance has been performed as and when required.
Contact Randox RXSupport if electrical or mechanical system faults are identified.

For safety reasons the user should NOT carry out internal inspections of the analyser.
9. 7. 1 ANALYTICAL PROBLEMS
When contacting Randox RX Support for analytical troubleshooting problems please
have the following information available:
1. Analyser serial number.

2. ISE unit serial number.
3. Description of the problem.
4. Serial number and lot number Reference, Na+, K+ and Cl- electrodes.
5. Serial number and lot number of Calibrator A and B, wash solution, diluent and
quality controls used.
6. Recent results of calibrations.
7. Recent results of quality control samples.
8. Measurement results.
For further investigation, refer to the following list after the above checks have been
completed.

+44 (0) 28 9445 1070
Error Cause Action

Out of Stability of Cal- Agitate the Calibrator A bag prior to use to assure a
range ibrator A homogeneous solution. The onboard stability of
Calibrant-A is one month.
Stability and Calibrator B must be kept in a dark place in a cool
storage of room.
Calibrator B If the Calibrator B is expired, it should be replaced with

a new bottle. Calibrator B should be pipetted into a
sample cup on the analyser just before performing the
calibration to avoid evaporation
Validity of Check that the electrodes are within expiry date and
Electrode total measurement count is less than 10,000 samples.
If expired, the electrodes must be replaced.
Fitting of Check that the Electrodes are properly installed into
Electrode the ISE module without any fluid leaking from tubing
connectors and between electrodes.
Environment Check that the environmental temperature is within 15
temperature to 30ºC .
Cleaning After ISE cleaning, it requires about 30 minutes for
electrodes to stabilise before further measurement.
Noise Validity of Check that electrodes are not expired and total
Electrode measurement count is less than 10,000 samples.
If they are expired, the electrodes must be replaced.
Fitting of Check that the electrodes are properly installed into
connectors and between electrodes. Also check for
crystallization.

+44 (0) 28 9445 1070
Surrounding Check that the electrical noise spike from

equipment environmental sources (such as refrigerator or
centrifuge) is not affecting the ISE unit.
Check condition of the ground.
The power source should be separated from other
equipment.
Drift Just after Prime ISE several times.
electrode Leave the analyser for 15 minutes or more without any
exchange operation to allow the electrodes to stabilise.
Caused by After ISE cleaning, it requires about 30 minutes for
cleaning electrodes to stabilise before any further
measurement.
Validity of Check that electrodes are not expired and total
Electrode measurement count is less than 10,000 samples.
If expired, the electrodes must be replaced.
Fitting of Check that the electrodes are properly installed into
connectors and between
electrodes. Also check for crystallization in the path.
Exchanging Prime ISE to purge remaining air in the fluid path.
Calibrator A bag
Glutinous Sample Check for viscosity of sample.
When the viscosity of sample is abnormally high for
example in a hyperproteinemia sample, a “Drift error”
may occur.
Caused by Fibrin When the sample tube is not anti-coagulation (heparin)
type, the measurement should be performed after
leaving the sample for 30 minutes to settle the fibrin
down. Measurement can be interfered when fibrin is
pipetted into ISE unit.
Tubing Check for bent, twisted and loose connection of ISE
unit tubing.

+44 (0) 28 9445 1070
Air Caused by air in Prime the analyser and try ISE measurement again.
the SPT. When air exists in the sampling line, it can be
introduced to the ISE unit resulting in measurement
error.
Shortage of Exchange Calibrator A bag.
Calibrator A. Check tubing condition.
Prime ISE more than 10 times and try measurement
again.
Shortage of Pour 500 μ l of Calibrator B in a fresh sample cup and
Calibrator B run calibration again.
Air bubbles in Pour 500 μ l of Calibrator B in a fresh sample cup and
Calibrator B. run calibration again.
Shortage of Add sample to sample cup and rerun measurement.
sample
Air bubbles in a Remove air from sample.
sample
Abnormal Check for the working hour counter on the job menu
movement of [Maintenance].
pump. (Supply or When the working hour pump cassette exceeds the
Waste pump.) use period
(180 days), replace the supply and drain pumps.
Tubing Check for bent, twisted and loose connection of ISE
unit tubing.
Poor connection Check that the Electrodes are properly installed into
of Electrode the ISE module without any fluid leaking from tubing
connectors and between electrodes. Also check for
crystallization in the path.
Check for displaced compression plate spring.
Electrode “O”-ring Check for proper fit of the “O”-ring between electrodes.
When “O”-ring is defective or deformed, exchange with
new “O”-ring.

+44 (0) 28 9445 1070
9999 Communication Check for misalignment of Electrodes, movement of

or error between supply or waste pump and tubing connection.
others analyser and ISE Check for a dirty sample port at the top of ISE unit.
module. Prime ISE and prime analyser.
When the above does not solve the situation, contact
customer support for assistance.
9. 7. 2 EQUIPMENT PROBLEMS
When contacting Randox Customer Support department for assistance with
troubleshooting problems please have the following information available:
1. Analyser serial number (see plate on rear of analyser)

2. Software version number (See System Parameters/System (F9)
screen.
3. Description of problem along with details of any relevant alarm codes
4. Any other information relating to equipment or maintenance.

+44 (0) 28 9445 1070

+44 (0) 28 9445 1070
APPENDIX A THEORY OF CALCULATIONS Version 2.0 Rev September 2009
APPENDIX A.
THEORY OF CALCULATIONS

+44 (0) 28 9445 1070
A.1 DATA PROCESSING AND CONVERSION
A. 1. 1 REACTION PROCESS AND MEASUREMENT POINTS

Measurements are taken at 20 second intervals over a 10 minute period. This results
in a maximum throughput of 180 photometric tests per hour. During each cycle the
system either adds sample, adds reagent, mixes or takes a measurement.
Measurements may be taken at one or two wavelengths, depending on the assay
specific chemistry parameters.
RX Daytona Timeline
Measurement R1 S Mix 1 to 13 R2 Mix 14 to 26
Point
Time -20 0 20 40 to 380 304 308 440 to 680
(seconds)
Measurement Measurement Range 2

Range 1
A. 1. 2 WATER BLANK
A water blank is performed on each cuvette during the washing process prior to R1
addition. This data is used to correct for minor variations in the cuvettes and also to
monitor the degree of cuvette staining.
A. 1. 3 ABSORBANCE DATA
The formula for conversion of the measured voltage to absorbance is as follows:
P: Path Length (mm) is 6.0mm.
V: Measured voltage (volt) of sample (less than 5 volts).
Voff: Offset correction voltage. Should be 0 to 1 volt and V-Voff >0.
10 5
Absorbance…mAbs = 1000 × ------ log --------------------
P V – Voff
Individual programs are set up on the Chemistry Parameters screen. The
measurement conditions are different for each method. All samples are corrected for
the water blank.
W1: Water blank with secondary wavelength
S1: Absorbance of sample with secondary wavelength

+44 (0) 28 9445 1070
W2: Water blank with primary wavelength

S2: Absorbance of sample with primary wavelength
Absorbance of sample is ABS1-26 for measurement points 1 to 26. The formula for
absorbance is as follows:
Primary wavelength: ABS1-26 = (S2-W2) 1-26
Secondary wavelength: ABS1-26 = (S1-W1) 1-26
Total wavelength: ABS1-26 = (S2-W2) 1-26 - (S1-W1) 1-26

+44 (0) 28 9445 1070
A.2 MEASUREMENT PRINCIPLES

The system measures the standard sample, calculates absorbance differences
(ΔABS) from the reaction process (time course data), constructs the calibration curve
and converts to a concentration value based on the calibration curve data. Two assay
types are available, one is an end-point based method (END), the other is a rate-
based method (RATE).
A. 2. 1 END-POINT METHOD (END)

The median value is calculated from the measurement ranges 1 and 2. The
absorbance value in the measurement points is shown as ‘X’.
If the number of values of n is odd:
X = X n +1
2
If the number of values of n is even:
1⎛ ⎞
X = ⎜Xn + Xn ⎟
2 ⎜⎝ 2 +1 ⎟
2 ⎠
The formula for ΔABS using an end-point method is as follows:
ΔABS = Median value of measurement points 2 - Median value of measurement point

1 (mABS)
A. 2. 2 RATE METHOD
The variation of the reaction in a measurement point is approximated by primary
regression. The variation of the reaction between measurement point 1 and
measurement point 2 is calculated.
The formula of the primary regression is as follows:
Y = a + bX
(Y: Absorbance X: Time a : Intercept b : Slope)

The formula of slope ‘b’ if the number of data points is ‘n’ is as follows:

+44 (0) 28 9445 1070
n
⎛ n ⎞⎛ n ⎞
n∑ xi yi − ⎜ ∑ xi ⎟⎜ ∑ yi ⎟
b = i =1 ⎝ i =1 ⎠⎝ i =1 ⎠
2
n
⎛ n ⎞
n∑ xi − ⎜ ∑ xi ⎟
2
i =1 ⎝ i =1 ⎠
The formula of ΔABS for a rate-method is as follows:
ΔABS = The slope of measurement point 2 - The slope of measurement point 1

(the units are mABS/minute).
A. 2. 3 REAGENT BLANK CORRECTION

The reagent may have an inherent absorbance that may interfere with the calculation
of concentration from the absorbance values, this may vary slightly over time, or with
different reagent lots. Therefore a reagent blank measurement should be performed
on the first round of each day or after exchanging reagent bottles.
There are 3 methods for reagent blank measurement.
1. Reagent blank measurement without sample added

2. Reagent blank measurement with system water as sample
3. Reagent blank measurement with saline solution as a sample on the ASP tray
For methods 1 and 2 above, time-course data for the reagent blank and cuvette blank
is saved for each method. These values will be used to offset the absorbance during
measurement of test samples.
Method 3 is used when a one point offset is performed using saline as S1.
ABSS1 - ABSS26= Time course of sample absorbance value

ABSSW = Cuvette blank absorbance value during sample measurement
ABSR1 - ABSR26= Absorbance value of reagent blank time course
ABSRW = Cuvette blank absorbance value during reagent blank
measurement

+44 (0) 28 9445 1070
Using the above definitions, the time course calculation used to obtain the change in
absorbance (ΔABS) will be as follows:
When a reagent blank is not used.

Time course absorbance value = (ABSS1 - ABSSW) - (ABSS26 - ABSSW)
When a reagent blank is used.

Time course absorbance value = ((ABSS1 -ABSSW) - (ABSR1- ABSRW)) - ((ABSS26-
ABSSW)-(ABSR26-ABSRW))
When method 3 is used (Reagent blank measurement with saline solution as a

sample on the ASP tray).
Time course absorbance value = (ABSS1- ABSSW) - (ABSS26 - ABSSW)

+44 (0) 28 9445 1070
A.3 EXAMPLES OF ENDPOINT ASSAY METHODS
A. 3. 1 END1: 1 POINT ‘END’ METHOD

ΔABS = The median of the measurement range
Single-shot (single reagent) R1 assay
ABS measurement range
Time
Two shot (2 step R2) assay)
ABS measurement range
dispensing of R2 Reagent
Time

+44 (0) 28 9445 1070
A. 3. 2 END 2: 2 POINT ‘END’ METHOD
ΔABS = The median value of measurement range 2 – The median value of

measurement range 1
One shot (single reagent R1) assay
ABS
measurement range 2
measurement range 1
without R2 reagent
Time
ΔABS = The median value of measurement range 2 – The median value of

measurement range 1
* (S+R1/S+R1+R2)
S: Sample volume
R1: R1 volume
R2: R2 volume
Two shot (2 step R2) assay.
ABS Measurement range 2

Measurement
range 1
R2 reagent
dispensation
time

+44 (0) 28 9445 1070
Sample Blank

+44 (0) 28 9445 1070
A.4 EXAMPLES OF RATE BASED METHODS

A. 4. 1 RATE 1: 1 POINT RATE-METHOD
ΔABS = The slope of the measurement range
For R2, 2 shot assay method
ABS
measurement range
dispensing
of R2 Reagent
Time
For single step, 1 shot assay method
ABS
measurement range
Time
A. 4. 2 RATE 2: 2 POINT RATE METHOD
ΔABS = The slope of measurement range 2 – The slope of measurement range 1
ABS
measurement range 1
measurement range 2
Dispensing
of R2 reagent
Time

+44 (0) 28 9445 1070
A.5 MEASUREMENT RESULT CHECK

Before the conversion of absorbance values and calculation of the concentration, it is
possible to perform the following checks:
• Linearity Check
• Absorbance Limit Check
• Prozone Check
• Duplicate Limit Check
• Sensitivity Limit Check
• Triplicate
These limit checks can be set on the Parameter, Normal 2 screen
A. 5. 1 LINEARITY CHECK
The linearity of kinetic assays (RATE method) is calculated by measuring the
deviation of the reaction curve from linear behaviour. If the specified value is
exceeded, the system will show a LIN flag attached to the result indicating that the
sample has failed the linearity check.
When the measurement range is set as 1 point, linearity is only checked for
measurement range 2. When the measurement range is set as 2 point, linearity is
also only checked for measurement range 2 (measurement range 1 is ignored in both
cases).
Range of measuring range 2 (measurement point number) = n (n is 4 or greater).

Absorbance of starting point of measurement range 2 = ABS1 (Reagent blank is
subtracted).
Absorbance of the last point of measurement range 2 = ABSn (Reagent blank is
subtracted).
ABS1 + ABS2
Movingaverage1 = ----------------------------------------
2

+44 (0) 28 9445 1070
ABS2 + ABS3
Movingaverage2 = ----------------------------------------
2
ABS ( n – 1 ) + ABS ( n )
Movingaverage ( n – 1 ) = ----------------------------------------------------------
2
The slope of the moving average for points 1 to 3 will be calculated by regression
analysis.
This will be ΔABSfirst.
The slope of the moving average for the last 3 points (n-3) to (n-1) will be calculated
by regression analysis.
This will be ΔABSlast.
The slope of the moving average over the measurement range, 1 to (n-1) will be
calculated by regression analysis.
This will be ΔABSslope.
LinearityLimit = ΔABSfirst – ΔABSlast- × 100 %

--------------------------------------------------------
ΔABSslope
ΔABSslope
ΔABSlast
ΔABSfirst
1 1 2 3 4 5 6 7 8 9 10 11 12 13
34 14 15 16 17 18 19 20 21 22 23 24 25 26
68
Measurement range 1 Measurement range 2
Moving average
A Linearity check will not be performed if:
a. The Linearity Limit has not been set.
b. The ‘Rate’ method has not been selected.
c. The ΔABSslope ≤ check threshold (mABS/min).

+44 (0) 28 9445 1070
d. The ΔABSfirst -ΔABSlast ≤ check threshold (mABS/min).

e. The number of measurement points for range 2 is less than 4 points.
f. A higher priority error than LIN has occurred.
A. 5. 2 ABSORBANCE LIMIT CHECK

If samples of high concentration or high activity are measured, it may cause
erroneous test results due to substrate depletion. In order to establish the validity of
results, the reaction limit at the primary wavelength is defined. Samples with
measured ABS values that exceed this limit will be output with an ABS flag.
For A Decreasing Reaction

Reaction Select ‘decrease’ for a reaction with decreasing absorbance.
Limit 3500 mAbs/10 (Absorbance values which are less than
the limit value are not used)
ABS
Abs limit
Water blank value
Measuring range
For An Increasing Reaction:

Reaction Select ‘increase’ for a reaction with increasing absorbance.
Limit 25000mAbs/10 (Absorbance values which are greater than
the limit value are not used)

+44 (0) 28 9445 1070
ABS
Abs limit
Water blank value
Measuring Range
A. 5. 3 ABSORBANCE OF LIMIT CHECK FLAGS

Table: Absorbance of limit check flags
Table 1:
Flag Alarm
N/A All ABS at primary wavelength in the measuring range are within
the absorbance limit.
AB1 None or only one ABS at primary wavelength in the measuring
range is within the absorbance limit. Calculation of concentration is
not possible. Flag AB1 will be displayed.
AB2 Only 2 or 3 ABS at primary wavelength in the measuring range are
within the absorbance limit, the concentration is calculated and the
result output with flag AB2.
In the following example of a decreasing reaction,

1. No flag is given
2 AB2 flag is given with the result
3 AB1 flag is given and no result is obtained

+44 (0) 28 9445 1070
2 Absorbance limit
3
Water value blank
Measuring range
A. 5. 4 PROZONE CHECK FOR RATE ASSAYS

The prozone check is used to detect a high dose ‘Hook effect’ occurring in
turbidimetric immunoassays with excess antigen levels.
This has the effect that very high activity samples produce absorbance values
equivalent to low samples and therefore an incorrect result may be reported for rate
assays.
The formula for the prozone check value ‘P’:
( ABS SL 2 – F – ABS SL 2 – S ) ⁄ ( t SL 2 – F – t SL 2 – S )
P = ----------------------------------------------------------------------------------------------------------------------
( ABS SL 1 – F – ABS SL 1 – S ) ⁄ ( t SL 1 – F – t SL 1 – S )
SL1-S Slope range 1 Start 1 - 26 1st measuring point of slope

range 1
SL1-F Slope range 1 End 1 - 26 (SL1-F > SL1-S) Last measuring point of slope
range 1
SL2-S Slope range 2 Start 1 - 26 1st measuring point of slope

range 2
SL2-F Slope range 2 End 1 - 26 (SL2-F > SL2-S) Last measuring point of slope
range 2
If the specified value is exceeded, the system will output these results with a ‘PRO’
flag attached.

+44 (0) 28 9445 1070
A Prozone check is not performed for control samples or for samples with values
below the specified ‘Sensitivity Limit’.
S = ( ABS SL 1 – F – ABS SL 1 – S ) ⁄ ( t SL 1 – F – t SL 1 – S )
Actual Measurement Value

The absorbance of measurement points for the Prozone check range SL1 and SL2 is
represented by ‘X’.
The value ‘X’ is the measurement value for SL1 and SL2 ( ABSSL1 and ABSSL2 ) for
the prozone limit check.
If n is odd i.e the mid-point within the range
X = Xn + 1
------------
2
If n is even i.e. the average of the 2 midpoints within the range

1
X = --- ( X n + X n )
2 --- --- + 1
2 2
Prozone Check Formula

Actual measurement value ‘P’ is defined if the ranges SL1 and SL2 are defined.
P =ABSSL1-ABSSL2
Actual measurement value ‘P’ is defined if the range SL1 is defined.
P = ABSSL1 - ABSwaterblank ( ABSreagent blank is not subtracted)
If ‘Upper’ is selected
Error if ‘P > Prozone value’ (Prozone value is defined on the display menu)
If ‘Lower’ is selected
Error if ‘P < Prozone value’ (Prozone value is defined on the display menu)

+44 (0) 28 9445 1070
A. 5. 5 SENS CHECK FORMULA

The actual measurement value for ‘S’ (Sens) is defined by the following formula
whether SL1 or SL1 and SL2 ranges are defined.
S = ABSSL1 - ABSwaterblank (ABSreagent blank is not subtracted)
When "S < Sens value", Prozone Limit Check is not performed.
(Sens value is defined on the display menu)
Formula
Actual measurement value
Absorbance of measuring point for Prozone check range SL1 and SL2 is represented
’X’.
Value ’X’ is a measurement value for SL1 and SL2 ( ABSSL1 and ABSSL2 ) for
prozone limit check.
[1] X = X n + 1 if the number of values n is odd;(i.e. mid-point of the range)

------------
2
1
[2] X = --- ( X n + X n ) if the number of values n is even; (i.e.average of the middle 2
2 --- --- + 1
2 2
points within the range)

+44 (0) 28 9445 1070
A.6 CALIBRATION
A. 6. 1 MEASUREMENT PRINCIPLES OF CALIBRATION
By measuring a set of calibrators with known concentrations and calculating the
ΔABS values, a calibration factor can be defined:
ΔABS calibrator = f ( concentration calibrator )
The unknown concentration of a sample can be determined from the factor in the
above equation.
concentration sample = f inverse ( ΔABS sample )
A. 6. 2 CALIBRATION CHECK
Standards and Calibrators are measured in duplicate or triplicate. The following
checks are carried out if the functions are enabled on the Parameters Normal2 menu.
A. 6. 3 DUPLICATE LIMIT (ALLOWABLE VARIATION LIMIT)

If a Standard sample is set to be measured 2 or 3 times and the absorbance
difference between the measurements is larger than the threshold value a Duplicate
Limit error flag is generated (DUP).
The Absorbance Difference is calculated as follows:

• Threshold value = Absorbance of first measurement - absorbance of second
measurement
• Threshold value = Absorbance of second measurement - absorbance of third
measurement
• Threshold value = Absorbance of third measurement - absorbance of first
measurement
The threshold value can be set on the Parameters, Normal2 menu screen within the
range 1 to 99999. An invalid result (*1) will not be included in the calculation. In the
case of triplicate measurements, a duplicate error (DUP) will be generated on every

+44 (0) 28 9445 1070
invalid measurement. *1 Results with no error flag or an STB flag are valid. Results
with flags other than STB will be invalid.
Standard Sample Absorbance is measured as follows:

• When all three measurement values are valid (*), the median value of three values
will be used.
• When two measurement values are valid (*), the average of two values will be
used.
• When only one measurement value is valid, or one reagent blank value is used for
one point offset, that one value will be used.
• When there is no valid measurement value, a SEN limit error will be generated.
The threshold value can be set on the Parameters Normal2 screen within the range 1
to 99999. * Results with no error flag or STB flag are valid. Results with flags other
than STB will be invalid.
Under the following conditions a duplicate limit error flag will not be generated.
a. If the duplicate limit error check is disabled.
b. When S1 is the reagent blank and measured only once.
c. When a higher priority error than duplicate limit error occurs.
A. 6. 4 SENSITIVITY (ALLOWABLE SENSITIVITY LIMIT)

If the difference in absorbance, ΔABS, between the first and last calibrators in a full
calibration is smaller than the specified value the last calibration value will be used.

+44 (0) 28 9445 1070
A.7 CALIBRATION TYPE
A. 7. 1 FACTOR
ΔABS
10000
Δ ABS
sample
S1
Δ ABS s1
concentration
concentration sample K
The formula of the calibration curve is defined as:
K
concentrationsample = ∗ (ΔABSsample − ΔABS s1 )
10000
ABSS1 is the actual measured value of standard S1, and S1 is the known
concentration.
The concentration of the sample after calibration is defined as:
1
concentration sample = --- × ΔABS
b sample
A. 7. 2 LINEAR
ΔABS
Sn
S2
Δ ABS sample
S1
concentration
concentration sample

+44 (0) 28 9445 1070
The formula of the calibration curve is defined as:
ΔABS = a + b × concentration
where the intercept ‘a ‘ and slope ‘ b’ are calculated according to the ‘least squares’
method with:
n n
∑ yi – b ∑ xi
i=1 i=1
a = ---------------------------------------
n
n n n
⎛ ⎞⎛ ⎞
⎜ ⎟ ⎜ y i⎟
n ∑ xi yi –
⎜ ∑ xi
⎟⎜ ∑ ⎟
i=1 ⎝ i=1 ⎠ ⎝ i = 1 ⎠-
b = ----------------------------------------------------------------------
⎞2
n n
⎛
2
n ∑ xi – ⎜ ∑ x i⎟
⎜ ⎟
i=1 ⎝ i=1 ⎠
xi and yi are pairs of corresponding values, i.e. ABS and known concentration of
calibrators i.
n is the number of calibrators, i.e. the values from 3 to 7.
Concentration of the sample after calibration is defined as:
1
concentration sample = --- × ( ΔABS sample – a )
b
A correction of intercept a for a single calibrator Sx, using a 1point recalibration with
slope b remaining constant can be performed. Intercept anew will be defined after
correction as follows:
a new = ΔABS Sx – ( b × concentration Sx )

+44 (0) 28 9445 1070
A. 7. 3 SPLINE
A non-linear calibration curve may be obtained from the measurement of 3-7
calibrators by spline interpolation. A Spline function is determined as cubic spline
under the following conditions:
4. A cubic equation for a small section.
5. Adapt a specified function value for both end points on a small section of the
curve.
6. Apply the derivatives to each of the following sections of the curve.
= Calibrator Point
ΔABS
AS5
A S4
Asample
AS3 AS2
AS1
concentration
CS1
CS2 CS4 CS5
CS3 Csample
The formula for the calibration curve on each small section is defined as:
ΔABS = A * concentration 3 + B * concentration 2 + C * concentration + D
The procedure to convert the measured ΔABS to a concentration value is as follows:

1. Locate the section of the curve that fits the measured ABS.
2. Substitute the ABS into the cubic equation for that section, and convert it into a
concentration using either Cardano's formula or the Newton-Raphson method.
A. 7. 4 POINT TO POINT
In a Point to Point calibration each calibrator value, or point, is connected to the next
one by a straight line. For example, if there are 5 standards as shown below, the
calibration curve is composed of four straight lines (k1 to k4) between the 5 points.

+44 (0) 28 9445 1070
= Calibrator Point
ΔABS
AS5
A S4
Asample
AS3 AS2
AS1
concentration
CS1
CS2 CS4 CS5
CS3 Csample
The formula for the point to point calibration curve may be obtained from the following
equation:
ΔABS = a + b∗ concentration
a is derived as follows:
ΔABS Sk + 1 – ΔABS Sk
a = ΔABS Sk – ⎛ ------------------------------------------------------------------------------------------------- ⎞ × concentration Sk ]
⎝ concentration Sk + 1 – concentration Sk ⎠
b is derived as follows:
ΔABS Sk + 1 – ΔABS Sk
b = -------------------------------------------------------------------------------------------------
concentration Sk + 1 – concentration Sk
Therefore, the formula for calculating the concentration of the samples after
calibration is defined as:
1
concentration sample = --- × ( ΔABS sample – a )
b

+44 (0) 28 9445 1070
A. 7. 5 LOG-LOGIT
In the case of a log-logit calibration type, in which there are 5 calibrators, the formula
for the calibration curve is given as follows:
ΔABS = k /(r + exp(−ax 3 − bx 2 − cx − d ) + 1)
A. 7. 6 EXPONENTIAL

+44 (0) 28 9445 1070
In the case of an exponential calibration, with 5 calibrators, the formula of the

calibration curve is given by:
ΔABS = A * concentration 3 + B * concentration 2 + C * concentration + D

+44 (0) 28 9445 1070

+44 (0) 28 9445 1070
Figure B. 1 MAINTENANCE LOG SHEETS (NO ISE)
MONTH /YEAR
Before Starting 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Auto-start OR initialisation / full prime
Fill system water tank with water
Check volume of wash solutions and fill if required
Empty waste tanks
Ensure printer has sufficient paper
DAILY
Remove condensation from RCU chamber
Clean outside of reagent and sample probes with alcohol swab
Check cuvette water blanks
Clean ISE module and condition electrodes
Clean any stains from surface of instrument
WEEKLY-ensure system is turned off 1 2 3 4
Clean the ASP and RCU units
Clean the pipette covers, trough and mosaic plates
Clean exterior surfaces of wash probes with alcohol swab
Clean mixer paddles with alcohol swab
MONTHLY
Check reagent and sample pipetting precision
Check remaining hours of parts
Check IRU temperature
Ensure water and wash solutions are dispensed at troughs
Decontaminate and clean internal tubing
Clean external waste tanks with bleach solution
Clean cuvettes with wash solution 3
Check operation of fans
UNSCHEDULED
Replace halogen lamp (1000hrs)
Replace syringe plunger tips (600 hrs)
Replace diaphragm pumps (2000hrs)
Replace cuvettes
Replace stirrer
Replace pipettes
Page 327
Figure B. 2 MAINTENANCE LOG SHEETS (with ISE)
MONTH /YEAR
Before Starting 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Auto-start OR initialisation / full prime
Fill system water tank with water
Check volume of wash solutions and fill if required
Empty waste tanks
Ensure printer has sufficient paper
DAILY
Remove condensation from RCU chamber
Clean outside of reagent and sample probes with alcohol swab
Check cuvette water blanks
Clean any stains from surface of instrument
Clean ISE module and condition electrodes
WEEKLY-ensure system is turned off 1 2 3 4
Clean the ASP and RCU units
Clean the pipette covers, trough and mosaic plates
Clean exterior surfaces of wash probes with alcohol swab
Clean mixer paddles with alcohol swab
MONTHLY
Check reagent and sample pipetting precision
Check remaining hours of parts
Check IRU temperature
Ensure water and wash solutions are dispensed at troughs
Decontaminate and clean internal tubing
Clean external waste tanks with bleach solution
Clean cuvettes with wash solution 3
Check operation of fans
UNSCHEDULED
Replace halogen lamp (1000hrs)
Replace syringe plunger tips (600 hrs)
Replace diaphragm pumps (2000hrs)
Replace cuvettes
Replace stirrer
Replace pipettes
Page 328
APPENDIX C SOFTWARE UPGRADE PROCEDURE Version 2.0 Rev September 2009
APPENDIX C
SOFTWARE UPGRADE PROCEDURE

+44 (0) 28 9445 1070
C.1 SOFTWARE UPGRADE (PCV130/MAINV136)

This procedure is required to upgrade the Rx Daytona software to version (PCv130
and Mainv136). Please read the instructions carefully and make sure the correct disk
is available with the up to date software versions and various engineering programs
and information. For versions, please refer to the instructions provided on the
upgrade CD. NO DATA will be lost during this upgrade if completed successfully.
PLEASE NOTE: This procedure can only be performed if the instrument has
PCv 121 or greater software already installed.
PLEASE NOTE: For software versions released after 130/136 please refer to the
documentation supplied on the upgrade CD.
C. 1. 1 PREPARATION FOR UPGRADE

With the PC and analyser connected, check that the current PC software version is
PC130, the last three numbers are required. (This information can be found at the
System Parameters/System Screen). Make a note of the main software version as
well (this will be required later). If the PC version is not PC130 please contact RX
Support (rxsupport@randox.com).
1. Go to the System Parameters/Backup Screen.

2. In the Data Backup field select Save Data by pressing SAVE.
3. Press YES. Wait for ‘backup completed successfully’ message as shown below.
(This may take several minutes).
4. Press OK to finish data backup.

5. Shut down the user interface software by pressing 'CTRL' and '.' simultaneously,
select 'POWER OFF', at the shut down analyser message select 'YES'.

+44 (0) 28 9445 1070
C. 1. 2 UPDATING THE DAYTONA SOFTWARE BACKUP ON THE PC

1. Double click 'MY COMPUTER' and go to the D:\ drive.
2. Insert the new D130A Software Update CD and copy all the folders onto the D:\
drive.
3. Select 'YES TO ALL' if prompted to confirm overwrite of existing data. A backup
copy of all the up to date software and various other programs are now saved on
the hard drive.
4. Remove the CD.
5. Go to Start/Settings/Control Panel and select 'ADD/REMOVE PROGRAMS'.
6. Select 'ANALYSER', 'REMOVE' and 'YES'.
C. 1. 3 UPDATING THE ANALYSER PC SOFTWARE

Go to the D:/Current Software folder and open the PCv130 folder. Then select your
language folder as shown below:
Name of folder Language
EN English
FR French
DE German
ES Spanish
IT Italian
PT Portuguese
ZH Chinese
1. Double click on the setup program as shown.
2. Select NEXT 3 times, select INSTALL and FINISH.

3. Close all windows- the PC software has been loaded.

+44 (0) 28 9445 1070
C. 1. 4 PC LOCALISATION
PLEASE NOTE: This step may be bypassed if the user interface language is in
English
Due to the multi-lingual nature of the software it is necessary to localize Windows to
your local region setup. Please refer to the procedure ’PC Setup Region and
Language’ as enclosed for full instructions. This enables a localized keyboard to be
used if required.
1. Select START/PROGRAMS/ANALYSER and click on ANALYSER as shown

below.
2. Click on 'STOP' and then 'CANCEL'.

3. Go to the System Parameters/Backup page.
4. At the Backup Data field select LOAD DATA by pressing the 'LOAD' button.
5. Select 'YES' to confirm.
6. At the ‘Recovery Completed Successfully’ message press 'OK'.
7. Shut down the user interface software by pressing 'CTRL' and '.' simultaneously,
8. Select 'POWER OFF', at the shut down analyser message select 'YES'.
9. At the ‘Analyser Shutdown in Process’ message press 'STOP'.
C. 1. 5 UPDATING THE ANALYSER MAIN SOFTWARE
The following Procedure is for updating the Main Software on the analyser flash card

+44 (0) 28 9445 1070
using the dsu (Daytona Software Upgrade) program.

1. Open 'My Computer' and go to using the dsu (Daytona Software Upgrade) pro-
gram. Open 'My Computer' and go to the 'D:\ current software' folder.
2. Open the folder named 'Mainv136'.
3. Double click on the dsu program shown below.
4. Wait for the Update Complete message shown below.
5. Press OK. The main software is now upgraded. Close all windows.
C. 1. 6 UPDATING THE CHEMISTRY PARAMETERS

Please refer to 'Chemistry Parameter Importing Software Procedure' for full
instructions on how to install and update chemistry parameters.
C. 1. 7 SUMMARY
Once this has been completed the analyser is fully upgraded to PC 130 Main 136
software and the parameters updated and ready for use. If you have any queries
regarding the update procedure please contact RXsupport.
E-mail: rxsupport@randox.com
Tel: +44 (0) 28 9445 1070

+44 (0) 28 9445 1070

+44 (0) 28 9445 1070
APPENDIX D CHEMISTRY PARAMETER IMPORTING SOFTWAREVersion 2.0 Rev September 2009
APPENDIX D
CHEMISTRY PARAMETER IMPORTING SOFTWARE

+44 (0) 28 9445 1070
D.1 OVERVIEW
The chemistry parameter importing software allows chemistry parameter information
to be downloaded from the PC to the analyser. The software must be installed on a
PC with ’ANALYSER’ user interface software installed. This procedure refers to
Parameters version 8.0.
D. 1. 1 SOFTWARE VERSIONS
The parameter importing software is updated during software releases to maintain
compatibility.
D. 1. 2 MAXIMUM CAPACITY
The maximum number of methods that can be handled by ’DOWNLOAD’ software is
500. When downloading, the numbers of methods are counted during selection and
when the total exceeds 500, the following error message will be displayed:
‘Error reading master parameter data. 500 is the maximum’
Further downloading of parameters cannot be carried out.
D. 1. 3 LIMITATION
1. The language is English only. Multilingual software is available to users with
Windows XP running on their PC's.
2. ’DOWNLOAD’ software must be installed on a PC with ’ANALYSER’ user interface
software installed.
3. The ’ANALYSER’ user interface software must be terminated before running
’DOWNLOAD’ software.

+44 (0) 28 9445 1070
D. 1. 4 INSTALLATION
The DOWNLOAD software is provided in a self-extracting format and will be installed
automatically into the directories shown below.
To un-install the software, delete 'INSTALLATION DIRECTORY' as shown in the table
below.
The software only runs on a PC with ’ANALYSER’ user interface software installed.
Name while Name of the Installation Database

compressed software Directory Folder
Download downins.exe ChPrDown.exe C:\prmdown C:\prm-

software down\prmdb
D. 1. 5 DOWNLOAD SOFTWARE (PC TO ANALYSER)

This software enables users to select (out of a database of up to 500 methods) which
methods are stored in the analyser software.
D. 1. 6 INSTALLATION
1. Double click on ’MY COMPUTER’ and navigate to folder containing updated
parameter download software.
2. Double click on ’DOWNINS.EXE’ to run self-extracting software for automatic
installation.
3. When the pop up window opens for directory confirmation, press ’OK’. Do not
change installation location and name as the software refers to them. When
moved or renamed, the software will not run properly. Close all open windows.
4. The following folders will be created:
C:\prmdown The folder where the software is installed
C:\prmdown\prmdb The folder where the data will be stored

+44 (0) 28 9445 1070
D.2 USER INTERFACE

Figure D.1 User Interface Screen
Program version no.
FILEPATH ON PC
METHOD NAME
METHOD NO.
NO. OF REGISTERED METHODS

METHOD NAMES
STORED ON PC
PLEASE NOTE: CHrPrDown.exe cannot be used to delete existing methods

stored in the analyser software. Delete existing methods following the
procedure below.
D. 2. 1 UPDATE PARAMETERS FILE TO LATEST VERSION

1. Double click on “My Computer” then “Current Software” and then “Parameters”
folder containing correct parameters (prmdb file) for analyser.
PLEASE NOTE: Parameters are different depending on the filter configuration

of the analyser. Please ensure correct version is used or else measurements
will be taken at incorrect wavelengths.

+44 (0) 28 9445 1070
Figure D.2 Daytona D8.0 Parameters Folder
a) 660nm optical filter installed

b) 380nm optical filter installed
2. Right click on “prmdb” folder and select Copy.
3. Double click “C:” drive then double click “prmdown” folder. Right click in the white
space in the “prmdown” folder window and select Paste.
4. Confirm that you wish to replace existing folder by clicking “Yes to All”.
D. 2. 2 LOAD NEW METHODS INTO ANALYSER

1. Run the Chemistry Parameter Importing Software by double clicking on
“ChPrDown.exe” icon in “C:\prmdown” folder.
2. In the left window, hold down left mouse button and drag
selected method to a blank position in the right window. Release the left
mouse button. The method name will appear in the selected box with a
white background.
PLEASE NOTE: the order selected at this stage defines the order methods
appear in the analyser software.
If a blank position is not available refer to the following procedure to delete existing
methods stored in the software.

+44 (0) 28 9445 1070
3. After all the desired methods are placed in the right side window, press the
“COPY” button to download the information to the analyser. The background of
the transferred methods will appear in grey after transfer.
4. Terminate the software and close all open windows.
5. Restart the PC (click Start/Shut Down/Restart/OK)
6. Turn the Clinical Chemistry Analyser OFF and then ON again with the main
powerswitch.
7. Once the ‘Analyser’ software has loaded, click on the Chemistry Prm (F6) tab,
select the method field and press spacebar to confirm that the desired methods
have been transferred successfully to the analyser.
D. 2. 3 UPDATE EXISTING METHODS STORED IN ANALYSER

1. Run the Chemistry Parameter Importing Software by double clicking on
“ChPrDown.exe” icon in “C:\prmdown” folder.
2. From the left hand side window, select the method name to be updated, hold down
left mouse button and drag to right hand side window over the same method
name.
3. Release the left mouse button. Select ‘OK’ in pop up window to confirm transfer.
The name of the updated method will appear in the selected box with a white
background.
4. After all the required methods have been updated, press “COPY” to download the
information to the analyser. The background of the transferred methods will
appear in grey after transfer.
5. Terminate the software and close all open windows.
6. Restart PC (click Start/Shut Down/Restart/OK).
7. Turn the Clinical Chemistry Analyser OFF then ON again with the main power
switch.
8. Once ‘Analyser’ software has loaded, click on Chemistry Prm (F6) tab, select
method field and press spacebar to confirm desired methods have been
transferred successfully to the analyser.

+44 (0) 28 9445 1070
D. 2. 4 LAUNCH ANALYSER SOFTWARE

1. Launch ‘Analyser’ software (click on Start/Programs/Analyser/Analyser) if not
already open.
2. If the analyser had previously been shut down the following window will appear:
‘COMMUNICATING WITH INSTRUMENT’.
3. Click STOP and then click CANCEL on the subsequent ‘COMMUNICATION LINK
FAILED RETRY?’ window.
D. 2. 5 DELETE UNWANTED METHODS

For information on how to delete unwanted methods please contact RX support.

+44 (0) 28 9445 1070

+44 (0) 28 9445 1070
APPENDIX E GLOSSARY Version 2.0 Rev September 2009
APPENDIX E
GLOSSARY
Job Menu Permanent display on screen menu. Sections.

Includes RUN MONITOR, CHEMISTRY PRM, CALIBRATION,
QC, SYSTEM PARAMETERS, MAINTENANCE.
Global Menu Permanent display on screen buttons. Includes START, STOP,

EMERGENCY and ALARM.
Function/Tab keys On screen menu sub-options that change with the Job Menu
selection.
Flag Indication on a results printout to notify the user that the value is
outside acceptable limits.
Sno. Sample No - Patient sample number
RCU Scan Reagent Container Unit scan for reagent registration.
Profile User defined selection of tests to facilitate the test selection

procedure. e.g. se;ection of tests to show liver/heart function
Multi-standard set Standard or Calibrator used for a number of tests.
FD Floppy Disc Drive.
SPT Sample Pipette Unit.
RPT Reagent Pipette Unit.
ISE Ion Selective Electrode.

+44 (0) 28 9445 1070
APPENDIX E GLOSSARY Version 2.0 Rev September 2009
IRU Incubation Reaction Unit.
ASP Auto Sampler Unit.
RCU Reagent Container Unit.
WPP Water Pump Unit.
WU Wash Unit.
SWU Supply Water Unit.
MIX Mixing-Stirrer Unit.
DTR Detector Unit.
RPP Reagent Pump Unit.
SPP Sample Pump Unit.
Jig Customised tool manufactured for a specific purpose e.g.

alignment.

+44 (0) 28 9445 1070

RX Daytona Operator Manual v2.0 Sept 2009

Uploaded by

Copyright:

Available Formats

RX Daytona Operator Manual v2.0 Sept 2009

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

RX Daytona Operator Manual v2.0 Sept 2009

Uploaded by

Copyright:

Available Formats

FOREWORD Version 2.

0 Rev September 2009

©2009 by Randox Laboratories Ltd,. 55 Diamond Road, Crumlin,

All rights reserved. No part of this publication may be reproduced, stored

For Technical Support contact Randox Laboratories on:

TABLE OF CONTENTS .......................................................................................III

SECTION 1 SAFETY PRECAUTIONS AND INSTALLATION........................1

1.1 WARNING SYMBOLS ..............................................................................2

1.2 WARNING LABELS ..................................................................................3

1.3 WARNINGS FOR SAFE USE ...................................................................5

1.4 SAFETY PRECAUTIONS .........................................................................6

1.5 INSTALLATION REQUIREMENTS...........................................................9

1.6 TECHNICAL SPECIFICATIONS...............................................................11

1.7 SYSTEM CONFIGURATION AND EQUIPMENT LIST.............................15

1.8 EQUIPMENT LIST ....................................................................................16

SECTION 2 SYSTEM OVERVIEW ..................................................................19

2.1 ANALYSER OVERVIEW...........................................................................20

2. 1. 3 First Reagent Measurement.....................................................22

2. 1. 4 Second Reagent Measurement ...............................................23

2.2 SYSTEM COMPONENTS.........................................................................25

2. 2. 2 Reagent Container Unit (RCU) ................................................27

2. 2. 3 Sample Pipette Unit (SPT) .......................................................29

2. 2. 4 Reagent Pipette Unit (RPT) .....................................................30

2. 2. 5 Incubation Reaction Unit (IRU) ................................................31

2. 2. 6 Detector Unit (DTR) .................................................................32

2. 2. 7 Stirring Unit (MIX-1 & MIX-2) ...................................................33

2. 2. 8 Wash Unit (WU) .......................................................................33

2. 2. 9 Pump Unit ...............................................................................35

2. 2. 10 Electrolyte Measurement Unit (ISE Option) .............................37

2.3 SOFTWARE OVERVIEW .........................................................................40

2.4 SCREEN LAYOUT....................................................................................44

SECTION 3 SYSTEM PREPARATION AND ROUTINE ANALYSIS ..............47

3.1 PREPARATION FOR ANALYSIS .............................................................48

3. 1. 2 System Initialisation and Prime ................................................51

3.2 GENERAL OPERATING PROCEDURE...................................................55

3. 2. 2 Registration Of Reagents, Diluents And Wash Solutions ........56

3. 2. 3 Register Calibrators, Controls And Patient Samples ...............61

3. 2. 4 Test Selection For Barcoded Patient Samples ........................77

3. 2. 5 Loading Calibrators, Controls And Barcoded Patient

3. 2. 5. 4. 2Types of Barcode Label ........................89

3. 2. 6 Test Selection For Non-barcoded Patient Samples .................93

3. 2. 7 Loading Calibrators, Controls And Non-barcoded Patient

3.3 START ANALYSIS....................................................................................102

SECTION 4 ACCESSORY FUNCTIONS.........................................................111

4.1 INTERRUPTION OF MEASUREMENT ....................................................112

4. 1. 2 Interruption Of Sampling ..........................................................112

4. 1. 2. 2 Sample Interruption to Load Normal Samples ........116

4.2 SAMPLE RE-RUNS ..................................................................................120

4. 2. 2 Result Outside The Measuring Range .....................................120

4.3 CALIBRATION ..........................................................................................122

4.4 OPERATIONAL CONDITIONS AND PARAMETERS...............................127

4. 4. 5 Testing Order and Result Printout Order .................................145

4. 4. 6 Entry Of System Parameters ...................................................147

4. 4. 9 Entering Patient Information Details.........................................159

SECTION 5 RETRIEVAL OF RESULTS .........................................................165

5.1 AUTOMATIC PRINTOUT OF RESULTS ..................................................166

5.2 RETRIEVAL OF STORED RESULTS.......................................................167

5. 2. 2 Retrieval of Results by Patient ID ............................................172

5.3 RETRIEVAL OF QUALITY CONTROL VALUES ......................................175

5.4 RESULTS FLAGS AND ERROR FLAGS .................................................181