NCC-51 User Manual V15.05

PHOENIX NCC-51
Five-Part-Diff Auto Hematology

Analyzer
Operation Manual
NOTE:
1) Carefully read this manual before first operating the analyzer.

2) Inspect the electrical requirements of the analyzer before power on,
and properly connect the grounding wire.
3) Turn off the power to the analyzer and disconnect the power cord if the
analyzer is idle for a long time.
4) Do not run the analyzer if it’s in an abnormal or damaged condition.
5) There is potential biohazard of the reagents and samples; operator
should follow proper biosafety practices. Dispose of waste reagent and
sample in accordance with local, national regulations.
Contents
Chapter 1 Introduction ................................................................................................................... 1
1.1 Overview .......................................................................................................................... 1
1.2 How to Use This Manual .............................................................................................. 2
1.3 Hazard Sign ..................................................................................................................... 2
1.4 Guidance .......................................................................................................................... 2
1.5 Parameters ...................................................................................................................... 3
Chapter 2 Safety Information for Operation................................................................................ 5
2.1 Overview .......................................................................................................................... 5
2.2 Special Requirements .................................................................................................. 5
2.3 General Requirements.................................................................................................. 5
2.4 Electromagnetism Security......................................................................................... 6
2.5 Installation ....................................................................................................................... 6
2.6 Prevent Infected ............................................................................................................. 7
2.7 Reagent ............................................................................................................................ 7
2.8 Maintenance .................................................................................................................... 8
2.9 Laser ................................................................................................................................. 8
2.10 Consumables................................................................................................................ 8
2.11 Security Sign ................................................................................................................ 9
2.12 Operators....................................................................................................................... 9
2.13 Computer Virus .......................................................................................................... 10
Chapter 3 System and Function................................................................................................... 11
3.1 Overview ........................................................................................................................ 11
3.2 Parameter ...................................................................................................................... 11
3.3 Structure ........................................................................................................................ 12
3.4 Counting Operation Screen ...................................................................................... 19
3.5 Reagent, Control and Calibrator .............................................................................. 20
3.5.1 Diluent ................................................................................................................. 21
3.5.2 Sheath ................................................................................................................. 21
3.5.3 Detergent ............................................................................................................ 21
3.5.4 Probe Detergent................................................................................................ 22
3.5.5 Lyse ...................................................................................................................... 22
3.5.6 Control and Calibrator .................................................................................... 22
Chapter 4 Installation ................................................................................................................... 24
4.1 Overview ........................................................................................................................ 24
4.2 Unpacking and Inspection ........................................................................................ 24
4.3 Space Requirements ................................................................................................... 25
4.4 Power Supply Requirements .................................................................................... 25
4.5 Environment Requirements ...................................................................................... 25
4.6 Waste Requirements ................................................................................................... 26
4.7 System Installation ...................................................................................................... 26
4.7.1 Computer Installation ...................................................................................... 26
Contents
4.7.2 Tubing Installation............................................................................................ 27

4.7.3 Printer Installation ............................................................................................ 28
4.8 Transport and Storage Requirement ...................................................................... 28
Chapter 5 Principles of Operation............................................................................................... 29
5.1 Overview ........................................................................................................................ 29
5.2 Sample Aspiration ....................................................................................................... 29
5.3 Sample Dilution ............................................................................................................ 29
5.3.1 Whole Blood Open Type Sampling Mode .................................................. 30
5.3.2 Pre-dilution Sampling Mode .......................................................................... 31
5.4 WBC Test Principle ..................................................................................................... 32
5.4.1 Four-Angle Laser Light Scatter Technology ............................................. 32
5.4.2 White Blood Cell Differential ......................................................................... 35
5.5 Hemoglobin Concentration Test Principle ............................................................ 36
5.5.1 Colorimetry Principle ...................................................................................... 36
5.5.2 HGB Parameter ................................................................................................. 36
5.6 Red Blood Cell /Platelet Test Principle .................................................................. 37
5.6.1 Electrical Impedance Principle ..................................................................... 37
5.6.2 Volumetric Metering......................................................................................... 38
5.6.3 Red Blood Cell Parameters............................................................................ 38
5.6.4 Platelet Parameters .......................................................................................... 40
Chapter 6 Settings ......................................................................................................................... 41
6.1 Overview ........................................................................................................................ 41
6.2 Time Setting .................................................................................................................. 41
6.3 System Maintenance .................................................................................................. 42
6.5 Display Setting ............................................................................................................. 48
6.6 Print Setting .................................................................................................................. 49
6.8 Group Parameters ....................................................................................................... 52
6.8.1 Limit Review ...................................................................................................... 52
6.8.2 Limit Modification............................................................................................. 54
6.9 User Management........................................................................................................ 54
6.10 Permission .................................................................................................................. 55
Chapter7 Daily Operation ............................................................................................................ 57
7.1 Overview ........................................................................................................................ 57
7.2 Preparations.................................................................................................................. 57
7.3 Startup ............................................................................................................................ 58
7.4 Quality Control ............................................................................................................. 59
7.5 Collection of Blood Samples .................................................................................... 60
7.5.1 Whole blood collection ................................................................................... 61
7.5.2 Pre-dilution sample preparation ................................................................... 61
7.5.3 Sample stability ................................................................................................ 62
7.6 Information Input ......................................................................................................... 62
7.7 Sample Counting ......................................................................................................... 64
7.7.1 Mode .................................................................................................................... 64
7.7.2 Counting and Analysis.................................................................................... 65
Contents
7.8 Data Query and Output .............................................................................................. 65

7.8.1 Data Query ......................................................................................................... 66
7.8.3 Data Deletion ..................................................................................................... 71
7.8.4 Repeatability ...................................................................................................... 71
7.8.5 Data Comparison .............................................................................................. 72
7.9 Reticulocyte Analysis ................................................................................................. 73
7.9.1 Principles of Operation ................................................................................... 74
7.9.2 Reticulocyte Sample Preparation................................................................. 76
7.9.3 Reticulocyte Test .............................................................................................. 76
7.10 Statistic ........................................................................................................................ 78
7.11 Shutoff .......................................................................................................................... 79
Chapter 8 Quality Control ........................................................................................................... 80
8.1 Overview ........................................................................................................................ 80
8.2 Quality Control Options ............................................................................................. 81
8.3 QC Mode Selection...................................................................................................... 82
8.4 L-J QC ............................................................................................................................. 82
8.4.1 L-J QC Edit ......................................................................................................... 82
8.4.2 L-J QC Run ......................................................................................................... 84
8.4.3 L-J QC Graph Analysis ................................................................................... 85
8.4.4 L-J QC Data Query ........................................................................................... 85
8.5 X-B QC ............................................................................................................................ 86
8.5.1 X-B QC Edit ........................................................................................................ 86
8.5.2 X-B QC Run ........................................................................................................ 87
8.5.3 X-B QC Graph Analysis .................................................................................. 87
8.6 X-R QC ............................................................................................................................ 88
8.6.1 X-R QC Edit ........................................................................................................ 88
8.6.2 X-R QC Run ........................................................................................................ 90
8.6.3 X-R QC Graph Analysis .................................................................................. 90
8.6.4 X-R QC Data Query .......................................................................................... 91
8.7 X QC ................................................................................................................................ 92
8.7.1 X QC Edit ............................................................................................................ 92
8.7.2 X QC Run ............................................................................................................ 94
8.7.3 X QC Graph Analysis ....................................................................................... 94
Chapter 9 Calibration ................................................................................................................... 96
9.1 Overview ........................................................................................................................ 96
9.2 Calculate Frequency ................................................................................................... 97
9.3 Preparation for Calibration........................................................................................ 97
9.4 Calibration Mode.......................................................................................................... 98
9.4.1 Calibrated Calibration ..................................................................................... 98
9.4.2 Whole Blood Calibration .............................................................................. 101
9.4.3 Manual Calibration ......................................................................................... 104
Chapter 10 Maintenance and Care............................................................................................ 106
10.1 Overview .................................................................................................................... 106
10.2 Routine Maintenance.............................................................................................. 106
Contents
10.2.1 Daily Maintenance ........................................................................................ 106

10.2.2 Weekly Maintenance.................................................................................... 107
10.2.3 Monthly Maintenance .................................................................................. 108
10.3 Maintenance procedure ......................................................................................... 110
10.3.1 Fluidics Cleaning ......................................................................................... 111
10.3.2 Diluent Replacement ................................................................................... 112
10.3.3 Detergent Replacement .............................................................................. 113
10.3.4 Sheath Replacement ................................................................................... 113
10.3.5 Cauterize Aperture ....................................................................................... 113
10.3.7 Clean Transducers ....................................................................................... 114
10.3.8 Prepare Shipping.......................................................................................... 115
10.3.9 Other Maintenances .................................................................................... 116
Chapter11 Troubleshooting ........................................................................................................ 118
11.1 Overview .................................................................................................................... 118
11.2 Troubleshooting Guidance ................................................................................... 118
11.3 Obtaining Technical Assistance .......................................................................... 119
11.4 Troubleshooting ....................................................................................................... 119
11.4.1 Faults Related to Reagents ........................................................................ 119
11.4.2 Faults Related to Test Value ...................................................................... 120
11.4.3 Fault Related to Hard Ware ........................................................................ 121
Appendix A Specifications .......................................................................................................... 122
A.1 Technical Specifications ......................................................................................... 122
A.1.1 Parameters ...................................................................................................... 122
A.1.2 Test Speed ....................................................................................................... 122
A.1.3 QC Mode .......................................................................................................... 123
A.1.4 Reagents of Product ..................................................................................... 123
A.1.5 Calibration Mode ............................................................................................ 123
A.1.6 Parameters Measurement and Calculation ............................................. 123
A.1.7 Input/output Devices..................................................................................... 123
A.2 Physical Specifications ........................................................................................... 124
A.2.1 Power Requirement....................................................................................... 124
A.2.2 Environment Requirement .......................................................................... 124
A.2.3 Storage Environment .................................................................................... 124
A.2.4 Size and Weight ............................................................................................. 124
A.2.5 Waste Disposal ............................................................................................... 124
A.2.6 Minimum Sample Volume ............................................................................ 124
A.2.7 Dilution Ratio .................................................................................................. 124
A.2.8 Counting Aperture ......................................................................................... 124
A.2.9 HGB measurement ........................................................................................ 124
A.3 Performance Index ................................................................................................... 125
A.3.1 Precision .......................................................................................................... 125
A.3.2 Linearity ........................................................................................................... 125
A.3.3 Accuracy of WBC five part differential ..................................................... 125
A.3.4 Carryover ......................................................................................................... 125
Contents
A.3.5 Background Counting .................................................................................. 125

A.3.6 Accuracy .......................................................................................................... 126
A.3.7 Display Range of Main Parameter ............................................................. 126
A.4 Reagent Specifications ........................................................................................... 126
A.5 Reagent Consumption ............................................................................................. 126
A.6 Parameters Alert Messages ................................................................................... 127
Appendix B External communication protocol ........................................................................ 128
Appendix C License for Manufacturing Measuring Instruments .......................................... 139
Appendix D Toxic and Hazardous Substances or Elements .................................................... 140
Appendix E Daily Operation Procedure ................................................................................... 141
Copyright and Declaration
Copyright © NeoMedica DOO.
Declaration:
All contents in this manual were strictly compiled according to related laws and
regulations in Serbia, as well as the specific condition of PHOENIX NCC-51
Auto hematology Analyzer, covering all the updated information before printing.
NeoMedica DOO is fully responsible for the revision and explanation of the
manual, and reserves the right to renovate the relevant contents without
separate notification. Some of the demonstration pictures are for reference
and subject to real object if any differences.
All the information included is protected by copyright. No part of this document
may be reproduced, stored or transmitted in any form or by any means unless
written authorization by NeoMedica DOO
All instructions must be followed strictly in operation. In no event should
NeoMedica DOO be responsible for failures, errors and other liabilities
resulting from user's noncompliance with the procedures and precautions
outlined herein.
Limited Responsibility for Quality Warranty:
The manual for PHOENIX NCC-51 Auto Hematology Analyzer, defines the
rights and obligations between the NEOMEDICA and the customers about the
responsibility for quality warranty and after-sale service, also the related
agreements on commencement and termination.
NEOMEDICA warrants the PHOENIX NCC-51 sold by the NEOMEDICA and
its authorized agents to be free from defects in workmanship and materials
during normal use by the original purchaser. This warranty shall continue for a
period of one year since the date of installation. The analyzer life is ten years.
NEOMEDICA assumes no liability in the following situations even during the
period of warranty:
a) Failure due to abuse the analyzer or neglect the maintenance.
b) Use reagents and accessories other than manufactured
or recommended by NEOMEDICA.
c) Failure due to operation not under the instructions described in the
manual.
d) Replace accessories not specified by NEOMEDICA, or after
maintenance or repair by a service agent not approved or authorized by
NEOMEDICA.
CAUTION:
THE ANALYZER IS FOR PROFESSIONAL AND PRESCRIPTION USE
ONLY.
Technical service and troubleshooting are provided by NEOMEDICA Customer
Support Center. Professional technician and sale representative will be sent to
offer you timely service when necessary.
NeoMedica DOO
Bul. Cara Konstantina 82-86, 18000 Niš, Serbia
Tel: +381 (18) 573-820, +381 (18) 573-606, +381 (18) 533-935
Fax: +381 (18) 573-616
Web: www.NeoMedica.rs
Email: info@NeoMedica.rs
Supplyed by NeoMedica DOO
Wellkang Ltd t/a Wellkang Tech Consulting

Suite B 29 Harley Street, LONDON W1G 9QR, UK
Version : V15.05
Chapter 1 Introduction
1.1 Overview
Welcome to read the Five-Part-Diff Auto Hematology Analyze’ s manual,
this manual including instrument operation, maintenance instructions and
matters needing attention, in order to keep the instrument has a good
performance, you must according to this manual to do the operation and
maintenance.
NCC-51 Five-Part-Diff Auto Hematology Analyzer is an in vitro diagnostic
medical device. It can analyze and output 34 parameters of the specimen
(including 6 graphics). The Optical detection section uses semiconductor
laser to analyze the five part differential of white blood cells, Coulter
theory to analyze red blood cells，platelet, and uses colorimetry for
hemoglobin concentration
NOTE
¾ Read this instruction carefully before operating, especially the safety
information. Please keep this manual properly for future reference.
¾ If the user does not operate the instrument according to operation manual,
misemployment will lead to inaccurate measurement and cause
misdiagnosing, delaying patient’s treatment or doing harm to the operator
himself, even damaging the instrument.
¾ Any attempt to brief, optimize, improve or elide expected activities which
listed in operation manual will be likely to cause some negative impact on
the precision of instrument.
¾ User must follow the instruction strictly when he operating the NeoMedica
medical instrument.
1.2 How to Use This Manual

This manual contains general information, which is the best guidance for
new operators. Please read this manual thoroughly at the first use. You can
use contents to quickly find the required information in daily use. All related
personnel should read this manual.
1.3 Hazard Sign

This manual uses the following warning conventions:
Symbol Meaning
Denotes the operator should follow the instruction under

WARNING this symbol, or it may have a personal injury.
Denotes potential hazards that could result in a minor

injury, also used for conditions or activities which could
CAUTION
interfere with proper function of the analyzer.
Denotes special operator/service information or standard
NOTE
practices.
Denotes potential bio-hazard.

WARNING
Denotes a laser hazard which, if non-compliance with
procedures or engineering controls, may result laser
WARNING damage to eyes.
1.4 Guidance
Operator can find the information needed according to the chapters
Information Reference
Parameters Chapter 1 Introduction
Chapter 2 Safety Information for
Notices for Operation
Operation
Structure and Use Chapter 3 System and Function
Installation Chapter 4 Installation
Measurement Principle and Procedure Chapter 5 Principles of Operation
System Parameter Setting Chapter 6 Settings
Daily Operations Chapter 7 Daily Operation
Requirement and Method of QC Chapter 8 Quality Control
Requirement and Method of Calibration Chapter 9 Calibration
Maintenance Chapter 10 Maintenance and Care

Troubleshooting Chapter 11 Troubleshooting
Detailed Specification Appendix A
Communications Protocol Appendix B
Metrical Information Appendix C
Name and content of poisonous and
Appendix D
harmful substances or elements
Daily operation procedures Appendix E
1.5 Parameters
Item Content Explanation

Test 34 parameters(with Scatter diagram, histogram, three
Parameter graphics) dimensional stereogram
Open type sample
Operation Only need 20µL Blood sample for test
injection mode
Software suppo rts online and U disk
Language English
upgrade.
Equipped with brand
Display Data management and networking are
computers and LCD
Setting convenient.
monitors .
Data
≥ 200 000 test results (with graphics)
Storage
Speed ≥ 60 / h
Exte rnal printer,
choose to prin t the
h istogram. Different
Output Reference range can be printed out
warning signs p rompt
Mode in English report format.
p robable
abnorma lities of
spec imen.
Whole Blood Sampling
Blood Mode 20 µL An ticoagulation with
Volume EDTA-K2/EDTA-K3.
Pre-dilution Sampling
Mode 20 µL
Diluent, detergent, Detergent (non-toxic environment-friendly
Reagent
reagents), sheath
Use the automat ic
Sample washing dev ice to
Aspiration f lush the inside and Avo id samples c ross contamination
Probe outside wall of and operators contact the sa mples.
Rinsing sample asp iration
p robe.
Prec is ion stepper

Blood High precis ion and Wear
motor sample
Separation res istance
aspiration
With two units selection
Un it Meet the paramete rs unit requests
for WBC, RBC, HGB, PLT
Selection fo r d ifferent countries and places.
and other items.
Cyanide-free
quate rna ry En vironmental regents can avoid the
ammonium sa lt effects of ope rators' health, and be
hemoglobin. good for environmental protection. If
HGB Test LED light source , use the tox ic reagents, you need to
540nm wavelength purchase spec ialist processing
colorimetry. equipment, which will increase
costs.
Control and With calibrator, fresh blood and manual calibration; With LJ, X, XR, XB
Ca libration control mode etc.
WBC ≤1.5% WBC： 0.0×109 /L -99.9×109 /L
RBC ≤1.0% RBC：0.1 ×1012 /L -7.00×1012 /L
Coeffic ient HGB ≤1.0% Linear HGB： 0 g/L-300g/L
of Variation M CV ≤1.0% ity
HCT ≤1.0% PLT： 0×109 /L -999×109 /L
PLT ≤4.0%
Adopt separately
St ruc tu re Enhance accuracy and maintain
removable syringe
e as il y
structure.
With automatic monitoring
function to prompt the
Improve the lifetime of equipment,
Maintenanc operator to perform
and maintain the best wo rking
e automatic maintenance or
conditions
troubleshooting
procedures.
Can be adjusted according to different
With 9 different groups
Reference geographical groups; and the instrument will
normal range parameter
Range automatically identify and match the best
setting function.
reference.
High-voltage cautery. Removable ruby aperture plate is easy to clean.
Flush
Positive and negative pressure recoil and intelligent automatic cleaning.
Security Have a good electrical security with the flow electricity isolation system.
Host Size L598.5mm×W 585mm×H488.5m m
Power ≤250VA
Fuse 250V/3.15A
we ight 65kg
Chapter 2 Safety Information for Operation
2.1 Overview
In addition to the safety use information, the general matters of operators
in terms of security are also shown in this chapter. Please read this chapter
carefully before operation.
2.2 Special Requirements

NCC-51 Five-Part-Diff Automated Hematology Analyzer is for blood cell
count, WBC five part differential and hemoglobin concentration
measurement in clinical laboratory.
Only allow to use the reagents and detergents mentioned in this manual.
Operating requirements also include regular cleaning and maintenance.
2.3 General Requirements

Read the operation manual before using. Understand all the important
signs. Please keep manual for future reference.
Following the manual instructions to start the analyzer, otherwise the
functions of the analyzer will lose due to accidental mechanical damage
and undesirable environment.
The instrument must be operated in accordance with the methods
mentioned in this manual strictly.
Keep long hair, fingers and clothes away from rotating parts with a certain
distance.
Turn off the power switch and unplug the power cord immediately if the
instrument gives off odor or smoke, otherwise it will cause fire, electric
shock or injury. If this happens, please contact the after-sale service
department.
Do not spill the samples or reagent and do not let other things to fall into
the instrument, otherwise it will cause short circuit. If this happens, turn off
the power switch and unplug the power cord immediately, then contact the
after-sale service department.
Do not touch the circuit, especially a wet hand, which will cause electric
shock.
The analyzer must be connected to a receptacle with correct voltage, and
grounding at the same time.Avoid damaging the power cord. Do not put
any device upon the power cord. Do not pull the power cord.
Turn off the power before connecting other devices (host computer,
printer).
The instrument is connected with AC power. There is a hazardous voltage
symbol in the interface. Using power adapters of other brands may cause
wrong test results due to the substandard technique data
2.4 Electromagnetism Security

The motor is inside the instrument, it will produce alternative electric field
and magnetic field.
The instrument may not function properly due to the strong
electromagnetic interference.
It may cause data conversion errors and incorrect results due to strong
electromagnetic interference and poor grounding.
2.5 Installation
The analyzer must be installed in dry and dust-free place. Avoid placing in
the place where is wet and with poor ventilation or in the dirty air with salt
and sulfur. Since the shell material is ABS + PC, it will be corrupted if being
placed in a high pH environment.
Avoid splashing water on the analyzer.
Do not expose the instrument to the place with large temperature
difference and direct sunlight.
Avoid vibration. The instrument should be put into the box with foam to
prevent damage during storage and transport. Improper package may lead
to abnormal operation of the instrument.
Installation site must be well ventilated.
This instrument does not produce ionizing radiation, but we should take
other equipment that generate strong ionizing radiation into consideration,
such as X-ray, γ-ray which may cause test results errors.
The equipment should not be installed in the place where stores chemicals
and generates gas.
The frequency and voltage required should be consistent with those in the
instruction and have the ability to allow current. The instrument should be
equipped with precision power supply or UPS.
The equipment is about 65kg, falling may cause injury during carrying.
Wrong reagent or incorrect operation may cause wrong results.
2.6 Prevent Infected

All the components and surface of the instrument have the potential
infectivity. The sample probe should keep an appropriate distance from the
surrounding objects in order to facilitate running.
Wear protective clothing and rubber gloves during operation, maintenance,
service or repair. Wash hands with disinfectant after work.
Do not contact the waste and its components with free hands.
If accidentally exposed to infectious material or surface, thoroughly clean
the skin with water immediately, and then operate according to the
laboratory disinfection procedures.
Instrument uses blood as samples. Blood may contain microbial
pathogens which can cause infection easily. Therefore, operation must be
done carefully, if necessary, wear protective gloves to prevent the operator
himself and people around being infected by pathogenic microorganisms.
Even the control and calibrator can be infectiously; we should wear
protective clothing and rubber gloves during calibration.
2.7 Reagent
Check marks on the package.
Avoid direct contacting with reagents, since the reagents may irritate eyes,
skin and mucous membranes.
If skin contacts with the reagent, rinse it with plenty of water immediately.
If eye contacts with the reagent, rinse it with plenty of water and seek
medical advice immediately.
Establish a set of emergency measures in laboratory is very necessary.
Protect the reagents from being polluted by dust, dirt and germs.
Reagents must be used within the validity period.
Handle the reagents properly to prevent bubble. Do not shake! The
reagent cannot be used immediately after transport.
Do not let the reagents spilt. If it happens, wipe away with a cloth.
If you swallow reagents accidentally, please seek the medical attention
immediately.
Diluent is a kind of good conductor, if being spilt next to the wire or device,
it may cause electric shock. Please turn off the power, unplug the plug and
clean the diluent.
The probe cleaning solution or detergent is strongly alkaline cleaner. Do
not let it contact the skin or clothes. If that happens, rinse the skin and
clothes with plenty of water immediately.
Probe cleaning solution contains sodium hypochlorite. If it contacts the
instrument surface, wipe up with a cloth immediately, otherwise it will
corrode the surface.
Ensure that the reagents keep the same level with the instrument or lower.
Do not put reagents on the top of the instrument.
2.8 Maintenance
As a precision electro-optical instrument, maintenance is necessary for
normal operation. The test data may have small deviations without regular
cleaning. In rare cases, operator might be infected due to poor cleaning.
To prevent infection, electric shock and burn, operator must wear rubber
gloves in maintenance work. Wash hands with disinfectant after work.
Use special tools for maintenance.
All the cleaning and maintenance procedures must be in accordance with
the manual operation.
Do the daily, weekly, monthly maintenance in accordance with the manual
operation.
If the instrument is not used for a long time, empty the rinsing flow
according to the procedure before disuse. Ensure the instrument is in a
good working condition before reuse.
Reinstallation can only be done when replacing standby parts.
2.9 Laser
The instrument uses semiconductor laser, the laser is protected by a
shield. If you remove the shield, the laser may burn your eyes and cause
harmful radiation. Only the service technician assigned by NeoMedica can
open the lid.
2.10 Consumables
The disposal of residual reagents, cleaning agent and all waste must
comply with local laws and regulations. Used samples and reagents should be
separated from ordinary waste, or they may cause environmental pollution.
Pollutants may also make the equipment unable to work.
2.11 Security Sign
Beware of electric shock
Protect from heat and radioactive

sources
Equipotentiality
Alternating current
In vitro diagnostic medical device
Lot number
Serial number
Use by
Metering License
Production Date
Manufacturer
CE
2.12 Operators
This medical instrument must be operated by well-trained personnel
exclusively. If being operated incorrectly by non-skilled staff,

misemployment will lead to inaccurate measurement and cause
misdiagnosing, delaying patient’s treatment or doing harm to the operator
himself, even damaging the instrument.
Failing to operate in accordance with instruction will lead to incorrect
operation, such as test parameter setting error. It may damage the
instrument and result in wrong diagnosis results.
Maintenance should be carried out by professional technicians. It will
cause test errors result from unauthorized technicians and nonstandard
maintenance.
Invalid hardware / software will affect the accuracy of test results. The
operator needs to contact the after-sale service personnel as soon as
possible.
2.13 Computer Virus
CAUTION
¾ Although our software has been checked to make sure there is no computer
virus, some measures must be considered in the daily operation. Here are
some checking procedures, but not completed. Depending on your
working conditions to choose appropriate measures:
1. Use a virus checker program for regularly checking.
2. Do not install other application program except virus checker program.
3. Do not open unknown email attachments.
4. Do not download any file which has nothing to do with the software program.
5. Check files in the folder for anti-virus.
6. Do not use U disk or other storage media on the computer to prevent them
bringing virus to the computer.
Chapter 3 System and Function
3.1 Overview
NCC-51 Five-Part-Diff Auto Hematology Analyzer is a vitro diagnostic
medical device. It is used for blood cell count, WBC five part differential and
hemoglobin concentration measurement in clinical tests. This instrument can
provide the accurate test data of human venous blood, which provide the
necessary reference for clinical diagnosis.
The instrument provides a fast count, all operations (including sampling,
measurement and results output) are fully automated. The instrument will
automatically start counting when detecting the samples. About 60
seconds, three-dimensional graphics data and results can be displayed
in the LCD screen. The results can be printed or transmitted to the LIS
system.
The biggest feature of the instrument is that as long as 20µL blood sample,
the white blood cells can be analyzed and then gives WBC five part differential
results.
3.2 Parameter
The instrument can analyze and arrange the samples data automatically
and shows the blood cell and white blood cell 5 part differential count
respectively. Also, it will give the three-dimensional plot and scatter diagram of
white blood cells and histogram of red blood cells and platelet.
The NCC-51 generates the following 34 test parameters in table
3-1(including two histograms, two three-dimensional plots and two scatter
diagrams).
Table 3-1 Parameters
Abbreviation Full Name Unit
9
WBC White Blood Cell Count 10 cells/L
LYM% Lymphocyte Percent %
MON% Monocyte Percent %
NEU% Neutrophil Percent %
EOS% Eosinophil Percent %
BAS% Basophil Percent %
LYM# Lymphocyte Count 109cells/L
MON# Monocyte Count 109cells/L
NEU# Neutrophil Granulocyte Count 109cells/L
EOS# Eosinophil Granulocyte Count 109cells/L
BAS# Basophil Granulocyte Count 109cells/L
RBC Red Blood Cell Count 1012cells/L
HGB Hemoglobin g/L
HCT Hematocrit (relative volume of erythrocytes) %

MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular Hemoglobin pg
MCHC Mean Corpuscular Hemoglobin Concentration g/L
RDW_CV Red Blood Cell Distribution Width repeat precision %
RDW_SD Red Blood Cell Distribution Width STDEV fL
PLT Platelet Count 109cells/L
MPV Mean Platelet Volume fL
PDW Platelet Distribution Width fL
PCT Plateletcrit %
P_LCC Large Platelet Count 109cells/L
P_LCR Large Platelet Percent %
RETIC Reticulocyte %
RETIC_ABS Reticulocyte absolute number 109/ul
IRF Immature Reticulocyte Fraction %
Remark: PCT and PDW are the inferred parameters. They are provided for
laboratory use only.
3.3 Structure
CAUTION
¾ The instrument needs several people work together to move since it is

relatively large. Please use proper tools and follow relevant safety code
when moving.
¾ Take out the instrument and then check whether the appearance is intact.
Ensure there is no damage during transport.
The analyzer is consisted of host, computer and an external printer
(optional).
Host is mainly composed of laser parts, automatic sampler, Syringe
Mechanism, A/D and the central control panel, the WBC measurement unit,
RBC/PLT measurement unit, liquid system, display screen and other parts,
accessories including the power cord, ground wire, etc.
12
Figure 3-1A Front View

1--- Counting Button Switch
13
Figure 3-1B Front View (Remove the front cover)
1--- Automatic Sampler

2--- Syringe Mechanism
3--- Solenoid Valve
4--- Optical reagents connectors
14
Figure 3-2 Right Side View (Remove the right side door)
1--- Automatic Sampler

2--- Specimen Cup
3--- Optical Path module Inside
4--- Syringes Module
5--- Fluid Reservoir
15
Figure 3-3 Left Side View (Remove the Left side door)
1--- Circuit board

2--- Serial Port and USB Interface
3--- Switching Power Supply
4--- Power Socket
5--- Power Switch
16
Figure 3-4 Rear View
1---Cooling Fan
2---Liquid Flow System baffle
17
Figure 3-5 Vertical View（Optical Bench）
WARNING
¾ Semiconductor Laser is above the instrument. Do not open the upper cover
for your safety, only the authorized personnel authorized by UNIT can open
it.
18
3.4 Counting Operation Screen

After startup, the instrument will enter into the count screen automatically.
Figure 3-6 Counting interface
This interface can be divided into the following areas by functions:

1. Main Menu Area
By clicking the button, operator can enter into corresponding interface to achieve
the functions. Please refer to the followin table to select the appropriate button.
Table 3-2 Main Menu Button
Button Function
Test Counting operations
Data Query the test results
Maintenance Replacement of reagents, maintenance of equipment
QC Run quality control operation
Calibration Scaling operations for instrument’s parameters
Setup Set system parameters
Statistics Workload statistics analysis
Service Maintain and test the equipment
19
Log Check the instrument operation and fault information

Help Operation help
About Check the instrument version information
logout Change user login
2. Data Edit Area

Display name, age, sex, blood type and other details of samples. The
operator can switch input methods to input sample information by pressing "Ctrl
+ Shift".
3. Shortcut Key Area

Table 3-3 Shortcut Key Button
Shortcut Key Function
Next serial number Input next ID number
Can do the blood routine examination,
Mode reticulocyte, whole blood and pre-dilution
switching operation
Transmit the test data to other computer systems
Transfer
manually, such as the LIS system
Print Print the test result
Print Preview
4. System Time
Display current date and time.
5. Counting Results Display Area
Display test results, parameter units, reference range, alarms, scatter plot, 3D
map and other results information.
3.5 Reagent, Control and Calibrator

The reagent is configured specifically for the NCC-51 flow systems in order
to provide optimal system performance. Each NCC-51 is checked at the factory
using the specified reagents and all performance claims were generated using
these reagents. Thus non- NeoMedica reagents may affect analyzer
performance, or result serious mistakes, even accidents. Reagents mentioned in
this Manual refer to matching reagents of the analyzer.
NOTE
¾ Reagents must be stored at room temperature to ensure optimal
performance. All reagents should be protected from direct sunlight,
20
undercooling and overheating during storage.

¾ The background test should be done after the replacement of diluent,
Detergent, sheath and detergent to ensure it is within the normal range.
¾ The reagent inlet tubes have a cap attached that minimizes evaporation and
contamination during shipping. The tubes can only insert reagent to right
connections. Please close the cap tightly.Ensure all reagents to be used in
validity period.
3.5.1 Diluent
Diluent is a tasteless transparent isotonic fluid, can be used for blood cells
counting and classification. It has the following functions:
(1) Dilute whole blood samples.
(2) Keep the shape of cells during test process.
(3) Clean WBC and RBC micro-aperture and tubes.
(4) Provide a conductive environment for counting
Storage and service life after opening: Keep the diluent under 5-35 °C, after
opened, it can be used to the validity period on the label. Once opened
(connected to the instrument), the product shelf life is only 60 days.
3.5.2 Sheath
Sheath is used to keep the original ecology of blood cells and bleach RBC
to eliminate the scattering of laser. WBC maintains the closest cell structure to its
original state. Basophil structure occur minor changes for the water-soluble
property of basophilic granule. RBC osmotic pressure is higher than sheath, so
RBC is changed by sheath. The hemoglobin of RBC diffuses from the cells, and
moisture content of sheath diffuses into cells. Although the cell membrane
remains good, but the RBC and sheath have the same refractive index, and it
showed under the laser virtually.
Storage and service life after opening: Keep the sheath under 5-35 °C, after
3.5.3 Detergent
Detergent which contents activity protease can be used to clean the tubes,
WOC/HGB cups, RBC cups and flow system.
Storage and service life after opening: Keep the Detergent under 5-35 °C,
after opened, it can be used to the validity period on the label. Once opened
21
3.5.4 Probe Detergent

Detergent contains the active enzyme to clean the agglomerated protein in
the WBC, RBC probes and measurement devices.
3.5.5 Lyse
Lyse which doesn’t contain the azide and cyanide is a new reagent. It meets
the following test requirements.
(1) Dissolve RBC instantly with minimum ground substance complex.

(2) Transform the membrane of the WBC to diffuse the cytoplasm. At the
same time, the membrane will shrink centre on nucleus. As a result, WBC is
present in granular shape.
(3) Transform the hemoglobin to the hemo-compound which is suitable for
the measurement in the condition of 540nm wavelength.
(4) Avoid the serious pollution to human body and environment that caused
by cyanide.
Storage and service life after opening: Keep the lyse under 5-35 °C, after
CAUTION
¾ Detergent and probe detergent is alkali cleaning agent

(1) Prevent skin and eyes from contacting the reagent.
(2) Once contact with skin, rinse with water.
(3) Once contact with eyes, rinse with water and seek medical treatment
immediately.
(4) If ingested, induce vomiting and seek medical treatment immediately.
3.5.6 Control and Calibrator
Control and calibrator are for instrument quality testing and calibration.
Control is an industrial production of whole blood. It is a hematology
reference control used in monitoring determinations of blood cell values on
hematology analyzers. It is with low, normal and high value. Three controls must
be run every day to ensure the reliability of the results. Calibrator is also an
industrial production of whole blood. It is used for calibration. Please refer to the
instruction of control and calibrator for use and storage methods.
22
The "control" and "calibrator" mentioned in this manual refer to the special
control and calibrator assigned by NeoMedica. Users can purchase from
NeoMedica or agents designated by NeoMedica.
23
Chapter 4 Installation
4.1 Overview
CAUTION
¾ Environment Requirements: Temperature: 15 °C ~ 35 °C; Relative

humidity: ≤ 85%;
¾ Place the instrument on a smooth and big enough platform which is easy
to operate. Away from direct sunlight.
¾ Try to use a separate AC receptacle, and install stabilized voltage supply
or UPS (Uninterruptible Power Supply). Do not share an AC receptacle with
centrifuges, room temperature shower (thermostat), refrigerators, air
conditioners or ultrasonic cleaning equipment or other equipment which
will interfere the instrument
CAUTION
¾ Installation of the analyzer by an unauthorized or untrained person could

result in personal injury which is exclusive of the warranty. Never attempt
to install and operate the analyzer without a NeoMedica authorized
representative.
This instrument has been tested strictly before delivery. It should be

carefully packed before transport in order to avoid being damaged. Check
the package carefully to see whether there is a physical damage when arrive.
If damaged, please immediately contact the after-sale service department of
NeoMedica or local agent.
4.2 Unpacking and Inspection

Take out the analyzer and accessories from shipping carton carefully,
keep the packing material for future transport or storage. Check as the
following:
(1) Quantity of accessories according to the packing list.
(2) Leakage or soakage.
(3) Mechanical damage.
(4) Bare lead, inserts and accessories.
Please contact NeoMedica Customer Support Center if any problem occurs.
24
4.3 Space Requirements

In order to ensure the proper space for operation, maintenance and
replacement of reagents, the host installation needs to meet the following
requirements:
(1) Choose a place near the power supply.
(2) Eight inches of space behind the analyzer must be left for air flow.
(3) There should be 100 cm of space above to either side of the analyzer for
service access.
(4) Sufficient space is required beneath for placing reagents, waste containers.
4.4 Power Supply Requirements

Be sure that the system is located at the desired site before attempting
any connections. See Table 4-1 for details.
Table 4-1 Power Supply Requirement
Optimal Voltage Voltage Range Frequency
AC 220V AC 100V～240V 50/60 Hz
WARNING:
¾ Analyzer should be used in the condition of well ground connection for
ensuring accuracy of instrument and safety of operator.
¾ A fluctuated voltage would impair performance and reliability of the
analyzer. Proper action such as the installation of AC manostat (not
provided by NeoMedica) should be taken before operation.
¾ Frequent power failure will seriously decrease the performance and
reliability of the analyzer. Proper action such as the installation of UPS (not
provided by NeoMedica) should be taken before operation.
4.5 Environment Requirements

(1) Temperature: 15～35°C (Optimum temperature is 25 °C)
(2) Relative humidity: ≤ 85%
(3) Recommend to install heating and cooling air conditioning
(4) Avoid using the instrument at extremely high or low temperature.
(5) Away from direct sunlight.
(6) Choose a well-ventilated place.
(7) Away from communication equipment which may interfere the instrument
by producing high frequency electric wave.
25
WARNING:
¾ The instrument takes full account of the electromagnetic compatibility
problems. The electromagnetic interference generated by instrument will
not disturb itself and devices nearby. If the test result has a large deviation,
please check whether the instrument is being placed near a
electromagnetic field or a short wave radioactive source (radar, X ray,
centrifuge, scanner, cell phone etc.).
4.6 Waste Requirements
WARNING:
¾ To prevent environmental pollution, the waste is prohibited to pour into the
sewer directly. The waste must be processed by biological or chemical
methods before pouring into the sewer. Hospitals and laboratories have
the obligation to comply with the relevant provisions of environmental
protection department of local government.
For every 20L waste, it is recommended to add the following chemicals into
waste containers:
(1) 50ml of sodium hydroxide solution (200g / L) to prevent gas forming.
(2) 250ml of sodium hypochlorite solution (12% chlorine) to handle the waste
biological risk.
4.7 System Installation
4.7.1 Computer Installation

Lowest configuration of computer equipped is:
CPU: Minimum 1GHZ Pentium Pro
Memory: Minimum 512MB Pentium Pro
Hard disk: Minimum 80 GB
Display Screen: Should be not less than 17 inch screen
CAUTION
¾ Please ensure that the computer equipped is only for controlling the
operation. If install other software, use removable storage devices such as
U disk, or play games, surf the Internet on the computer, etc., it will easily
being infected by virus and cause system damage or other errors.
26
4.7.2 Tubing Installation

There are five tube-connectors on the left panel: DETERGENT, DILUENT,
DETERGENT, SHEATH and WASTE, each of which is wrapped with a cap to
avoid contamination by the NeoMedica before shipment. Uncover and set the
caps aside carefully for further use on initial installation.
NOTE
¾ After installation, all tubes should be in a nature relaxed state and without
distortion.
¾ Using tools for tubing installation is prohibitive. Only installing by hand is
allowed.
¾ The reagent bottle cannot be used if there is damage, leakage, expiration
and other anomalies. Please contact with local suppliers or after-sale
service department of NeoMedica directly.
¾ To ensure safety and take optimal system performance into account,
NeoMedica recommend that all reagents should be placed on the same
base and lower than analyzer position.
1. DILUENT Tubing Installation
Remove the diluent tube with blue faucet from reagent kit and attach it to
DILUENT connector on the left panel. Place the other end into the diluent
container. Twist the cap until secure.
2. DETERGENT Tubing Installation

Remove the Detergent tube with red faucet from reagent kit and attach it
to DETERGENT connector on the left panel, place the other end into the
Detergent container. Twist the cap until secure.
3. SHEATH Tubing Installation

Remove the sheath tube with black faucet from reagent kit and attach it to
SHEATH connector on the left panel. Place the other end into the sheath
container. Twist the cap until secure.
4. WASTE Tubing Installation

Remove the waste tube with white faucet from reagent kit and attach it to
WASTE connector on the left panel, connect BNC plug to the socket marked
“SENSOR” on the rear panel. Twist the tube’s cap clockwise onto the waste
container until secure. Place the waster container on the level at least 50cm
lower than the analyzer.
5. LYSE Tubing Installation

Remove the lyse tube with white faucet from reagent kit and attach it to
LYSE connector on the left panel. Place the other end into the lyse container.
Twist the cap until secure.
27
4.7.3 Printer Installation

Following these steps to install the printer:
1. Place the printer in an appropriate location adjacent to the instrument so as
to operate easily;
2. Take out the printer from transport package.
3. Check the printer, if being damaged, please contact supplier;
4. Check the printer power;
5. Assembly the printer according to printer manual;
6. Connect the power cord to the printer,and grounding plug;
7. Confirm that the printer and computer are properly connected;
8. Install the ink cartridges and paper according to the instructions; ensure the
printer is adjusted to the correct receiver size;
9. Connect the power cord to a grounded outlet and turn the power on.
4.8 Transport and Storage Requirement

When the instrument is without using for a long time or before
transportation, please run the "Prepare Shipping" procedure. Please refer to
Chapter 10 "Maintenance and Care" for details. Proceed as follows:
1. Select "Non-use Packing" on the "Maintenance" interface;

2. Follow the prompts to unplug the relevant tubing connectors and keep the
waste interface;
3. Instrument starts emptying operation, and the progress bar is on the bottom
of the screen.
4. After emptying, back to maintenance interface.
NOTE
¾ Storage temperature: -20 °C ~ 55 °C;.
¾ Relative Humidity: ≤ 95%;.
¾ Atmospheric pressure: 50kPa-106kPa
¾ Before delivery, external disinfection is needed.
28
Chapter 5 Principles of Operation
5.1 Overview
NCC-51 uses electrical impedance method (also known as Coulter
principle) to detect the amount and volume distribution ofred blood cells and
platelets. The colorimetric method is for determining the content of hemoglobin.
The 4-angle laser scattered method is for the five part differential of white
blood cells. Three separated channels are used for getting the blood cells
counting results respectively.
(1) WBC and five part differential data of sheath are detected by laser.
(2) HGB is detected by colorimetric methods in WOC/HGB counting chamber.
(3) The data of RBC and PLT are detected by electrical impedance methods in
RBC counting chamber.
In each counting process, the instrument will aspirate, dilute and mix the
samples and then measure each parameter.
5.2 Sample Aspiration

NCC-51 supports two modes of cell blood counting analysis:
(1)Whole blood open type sampling mode
(2)Pre-dilution Sampling mode
The aspiration volumes are:

Whole blood open type sampling mode 20µL
Pre-dilution Sampling mode 20µL
The whole blood sample is aspirated into the analyzer by the precision
stepper motor and distributed into different measuring channels by shear
valve.
5.3 Sample Dilution

The sample is divided into two parts after being aspirated. These two parts
samples will inflood into the WOC/HGB cup and RBC pre-mixing cup
respectively, after react with different reagents will aspirate into optical WOC
flow cell and RBC cup to get the results of white blood cell counting /
hemoglobin measurement, red blood cell / platelet counting and WBC five
differential.
According to the different needs of the operators, the instrument provides
two operating modes: Whole blood open type sampling mode and Pre-dilution
Sampling mode
29
5.3.1 Whole Blood Open Type Sampling Mode

1. WBC / HGB Dilution Process
Whole Blood Sample 14ul
Add roughly 1.5ml Diluent
Dilution ratio is approximately 1:108
2. RBC / PLT Dilution Process
Whole Blood Sample 6uL
Add roughly 1ml Diluent
Pre-mixing Dilution Ratio is approximately 1:168
40uL pre-mixing liquid
Add roughly 9 ml Diluent
RBC/PLT test sample dilution ratio is approximately 1:226
3. WBC Differential Dilution Process

Whole Blood Sample 14ul
Add roughly 1.5ml Sheath
Dilution ratio is approximately 1:108
30
5.3.2 Pre-dilution Sampling Mode

1. WBC / HGB Dilution Process
Peripheral blood samples 20uL
Dilution ratio is approximately 1:8.5
32ul specimen for WBC/HGB test
2. RBC / PLT Dilution Process
8ul specimen for RBC/PLT test
3. WBC Differential Dilution Process
32ul specimen for WBC differential/HGB test
31
5.4 WBC Test Principle
5.4.1 Four-Angle Laser Light Scatter Technology
Figure 5-1 WOC Flow Cell
The whole blood samples are diluted with an appropriate proportion of

sheath; white blood cell remains its original state approximately. Using flow
cytometry to make the cells in a single arrangement flow. The scattering
density can be measured through the laser beam detection zone.
(1) 00: Forward Angle Light Scatter (10～30), which can be used to measure
cell size;
(2) 100: Narrow-Angle Light Scatter (70～110), which can be used to measure
cell complexity and structure.
(3) 900: Ninety-Degree Light Scatter (700～1100), which is mainly used to
measure the cell surface and internal structure.
(4) 900 D: Ninety-Degree Depolarized Light Scatter (700～1100), which can be
used to measure certain type of cell granularity .
32
Figure 5-2 Multi-Angle Laser Scatter Optical Bench

Light source is a vertical direction semiconductor laser with wavelength of
639±10nm and power is 10mw. Laser beam goes through a cylindrical lens
which can change the shape of beam spot from circle to oval. Then the beam
goes through a 125um cutting slit which can prevent low light passing through.
Finally, it is shaped into a spot with a 80um-wide cell through an imaging lens
and focus on the white cell in the quartz sheath flow.
The laser beam is small in the horizontal direction, so the cells do not
scatter laser much. If the remaining horizontal light reaches the 0° detector,
blocker can block it to prevent electronics saturation. The horizontal forward
angle light directly scatters to the punch hole through the convergent lens. The
light of 0 degree pass through the hole to the silicon photodiode detective unit of
0 degree.10 degrees scattering light reaches to the 10 degrees silicon
photodiode detection unit by reflector.
Vertical scattered light is collected by the condenser lens group, and then go
through a 700um cutting opening (filter stray light and improve accuracy). After
the scattered light which contains cell information passing through the
condenser lens group, the vertical scattered light will be divided into two parts
by a beam splitter mirror. A part of light directly scatters to the 90 degrees
photomultiplier tube. The remaining scattered light will go through the line
polarizer, and only the depolarizing scattered light can reach 90 degrees
depolarizing photomultiplier tube
33
Figure 5-3 Optical Detection System
1---System Work Platform

2---Cylindrical Mirror
3---Reflector Plate
4---125 Microns Slit and Bracket
5---Imaging Lens Group and Bracket
6---WOC Flow Cell
7---Forward Condenser Group and Bracket
8---PhotoAmp BOARD PCBA
9---Side Condenser Group and Fine-tuning Mechanism
10---700 Microns Slit and Bracket
11---Spectroscope and polarizer Bracket
12---314 PMT
13---131 PMT
14---Laser Bracket
15---Laser
16---High voltage circuit board
34
Figure 5-4 Scatter Plot Principle
The gray area on left scatter plot is the ghost cells. It reflects that RBC
dissolve into pieces on the scatter plot; green is for lymphocyte group; pink is
for monocyte group; blue is for neutrophil; white is for basophil group; red is for
eosinophil group.
Figure 5-5 Three-dimensional Plot

Figure 5-5 is a three-dimensional plot of WBC (3D). It can be magnified to
view WBC differential and change S0, S10, S90 relative positions according to
clinical experience.
5.4.2 White Blood Cell Differential

NCC-51 does the four-angle scatter analysis for the cells which go
through the WOC flow cell. White blood cells are being divided into 5 parts:
basophil, eosinophil, monocyte, neutrophil and lymphocyte. The default unit of
cells number is 109/L.
z White Blood Cell Number

The total number of white blood cells is obtained by four-angle laser light
35
scatter technology.
z Lymphocyte Number (Lym#)
z Lymphocyte Percent
Lym% = Lym#/WBC
z Monocyte Number (Mon#)
z Monocyte Percent
Mon% = Mon# /WBC
z Neutrophil Number (Neu#)
z Neutrophil Percent
Neu%=Neu#/WBC
z Eosinophil Number (Eos#)
z Eosinophil Percent
Eos%=Eos#/WBC
z Basophil Number( Bas#)
z Basophil Percent
Bas%=Bas#/WBC
5.5 Hemoglobin Concentration Test Principle
5.5.1 Colorimetry Principle

Add sheath into the diluted sample in WOC/HGB counting chamber. Red
blood cells will dissolve and release hemoglobin. Then the hemoglobin
combines with Detergent to form hemoglobin mixture. Use LED light-emitting
diode to illuminate the hemoglobin mixture by the monochromatic light of
540nm wavelength at one end of the WBC counting chamber. At the other end
using the optical tube to receive the transmitted light and then amplify the light
intensity signal to voltage signal. Compare it with the voltage generated by the
transmission light intensity before adding the sample into the colorimetry
chamber (only with diluent) to get the value of hemoglobin concentration.
Hemoglobin concentration is proportional to the absorbance of samples of
540nm wavelength. The process of measurement and calculation is done
automatically by the analyzer, and the results will be displayed in the analysis
results area.
5.5.2 HGB Parameter

Hemoglobin concentration (HGB) is calculated by the following formula:
36
⎛E ⎞
HGB = K × Ln⎜⎜ B ⎟⎟ ；
⎝ ES ⎠
Ln is a natural logarithm.
K is a constant.
EB is the luminous intensity of light pass through the background.
ES is the luminous intensity of light pass through the samples.
5.6 Red Blood Cell /Platelet Test Principle
5.6.1 Electrical Impedance Principle

The analyzer uses the traditional electrical impedance for the blood cells
testing and counting. See Figure 5-6, conductive liquid (mainly diluent)
provides constant current source for electrode to help the circuit form a stable
impedance loop. When the cells pass through the pores, the conductive liquid
is substituted by cells, and the resistance of loop changes to produce electrical
pulses. When different volumes of cells pass through the pore there will have
different electrical pulses amplitude. So we can determine the number and size
of cells according to the number and amplitude of electrical pulses.
Figure 5-6 Electrical Impedance

As the number of pulses corresponds to the number of cells pass through
the pores, the pulse amplitude corresponds to the volume of the cells, so the
analyzer can count and classify the cells according to size of the cells. The
analyzer automatically divides the cells into red blood cells, white blood cells,
platelets and other groups in accordance with pre-set volume classification
procedure.
37
5.6.2 Volumetric Metering
Figure 5-7 Volumetric Metering

The analyzer controls the quantity of samples that pass through the pore
during counting by volumetric metering unit to obtain the exact counting results
of blood cells in quantitative samples. The volumetric metering unit includes
volumetric metering tube and two photodetectors. As shown in Figure 5-7,
empty the volumetric metering tube before counting. When the sample flows
through the pore, the liquid level of volumetric metering tube will decline slowly.
When the liquid level passes through the start detector, it will produce an
electrical signal and then the analyzer starts counting; when the liquid level
reaches the stop detector, it also will generate an electrical signal and then
finish counting. If there are bubbles or other abnormal stream in the flow
system during the process, "bubble" or "clog" alarm will be shown. Please refer
to chapter 11 Troubleshooting for handling.
5.6.3 Red Blood Cell Parameters

z RBC Number
The instrument gets the number of red blood cell (RBC) by measuring the
corresponding electrical pulse numbers of RBC directly. The unit is 1012/L.
RBC = n ×1012 / L
38
z MCV
The mean corpuscular volume (MCV) is the average volume of individual red
blood cells. The MCV is derived from the RBC size distribution data. The unit is
fL.
z HCT
The hematocrit (HCT) is the ratio of red blood cells to plasma. It is expressed
as a percentage of the whole blood volume. The HCT is calculated from the
RBC count and the MCV as follows:
z MCH
The mean corpuscular hemoglobin (MCH) is the average amount of
hemoglobin in the red blood cell and being expressed in picograms. The MCH
is calculated from the RBC and the HGB as follows:
z MCHC
The mean corpuscular hemoglobin concentration (MCHC) is the ratio of the
weight of hemoglobin to the volume of the average red blood cell. It is
expressed in percent and calculated from the HGB and the HCT as follows:
z RDW-CV
The RDW-CV is derived from the RBC histogram and being expressed in
percent.
z RDW-SD
The RDW-SD is the width of 20% peak value of red blood cell distribution
histogram .The unit is fL.
39
5.6.4 Platelet Parameters

z PLT Number
The instrument gets the number of platelet (PLT) by measuring the
corresponding electrical pulses of RBC directly. The unit is 109/L.
PLT = n ×109 / L
z MPV
The mean platelet volume (MPV) is derived from the PLT histogram after the
PLT count has been determined. The unit is fL.
z PDW
The platelet distribution width (PDW) is a measure of the heterogeneity of the
PLT population. It is expressed as the geometric standard deviation. (10 GSD).
z PCT
The PLT is calculated as follows:
Remark: The unit of PLT is 109/L. The unit of MPV is fL
40
Chapter 6 Settings
6.1 Overview
Initialization setting of NCC-51 has been done before delivery. Setting of
the interface at the first boot is default. To meet the different needs, some
parameters can be re-set.
6.2 Time Setting

There are three formats of date: YYYY-MM-DD, MM-DD-YYYY, and
DD-MM-YYYY. Y indicates Year, M indicates Month, D indicates Day. If time
setting is changed, the time on screen and printed output will also change.
1. Entering into Setting

Click "Time" button on the "Setup" interface, and then enter into the
interface as Figure 6-1.
Figure 6-1 Time Setting
41
Chapter 6 Settings
2. Select Format
There are three formats of date: YYYY-MM-DD, MM-DD-YYYY, and
DD-MM-YYYY. Click the button to select the format needed.
3. Whether to use 24-hour format

If you want to use the 24 hour format, just need to tick in front of the small
box.
4. Save and Exit

Modify the date and time, then click the "Save" bottom in the right corner of the
interface shown in Figure 6-2. Click “Yes" to save the results; click "No" to exit.
Figure 6-2 save settings
6.3 System Maintenance

Instrument maintenance operation, alarm, language, etc., can be set in the
interface shown in Figure 6-3.
Figure 6-3 System Setting interface
42
Chapter 6 Settings
1. Auto Clean Setting

Please click “Maintenance-General” menu after you enter the "Setup"
interface, and then from the drop-down "Auto clean" button to select "times",
it is recommended that the flow system should be cleaned once for each 60
counting. See Figure 6-4.
Figure 6-4 Auto Clean Setting
43
Chapter 6 Settings
2. Alarm setting
Please click "Alarm" menu after you enter the " Setup " interface, and then
from the drop-down "General" button to choose whether to open the alarm and
waste alarm, it is recommended that the operator should open the alarm and
waste liquid alarm prompt. See Figure 6-5.
Figure 6-5 Alarm setting
44
Chapter 6 Settings
3. Auto Blank Setting

Please click "Maintenance" menu after you enter into the "Setup" interface,
and then tick the “Auto blank” in front of the small box . It is recommended to
select "on" in "Auto Blank” so that after each boot, the instrument can
automatically enter into counting interface and run background tests to check
whether the instrument is normal. See Figure 6-6.
Figure 6-6 Auto Blank Setting
4. Counting Time Setting

Enter into the "Setup" interface and then click " Counting time” menu. Set
the upper and lower limits of WBC and RBC counting time warning as shown
in Figure 6-7.The upper limit of RBC is 11 seconds. If the counting time is more
than this value, "Clog" will be alarmed. The lower limit of it is 9 seconds. If the
counting time is less than this value, "Bubble" will be alarmed. The upper and
lower limits of WBC are similar to those of RBC.
NOTE
¾ The upper and lower limits are set before delivery. Generally, they should
not be modified so as to avoid false alarm.
45
Chapter 6 Settings
Figure 6-7 Counting time setting
46
Chapter 6 Settings
6.4 Dictionary Maintenance

If the name of the same department or doctor needs to be inputted
repeatedly in the "Counting" and "Query" interface, the operator can set up a
simple code. When editing patient’s information, the operator only needs to
input the code and press "Enter" button, then the corresponding department or
doctor’s name will be displayed.
1. Entering into Dictionary Maintenance

Enter into "Setup" interface and click "Dictionary Maintenance", and then
the default interface will be displayed as Figure 6-8.
2. Department Code Setting
Click "Add", input the name of department in name box, such as "internal
medicine" and then input “1" in code column. If the operator wants to input
"internal medicine" next time, he only needs to input "1" then press "Enter".
Click "Delete" button to delete the code item established.
Click "Modify" button to modify the code item established.
Figure6-8 Department Setting
47
Chapter 6 Settings
3. Doctor Code Setting

Click "Sender" menu. Operator can establish a relationship between the code
and doctors' name to save input time.
Click "Add", and then input doctor's name in name box, such as "LiQiang" and
“002" in code column. Once the operator wants to input "LiQiang" next time, he
only needs to input "002" then press "Enter". See Figure 6-9.
Click "Delete" button to delete the code item established.
Click "Modify" button to modify the code item established.
Figure 6-9 Doctor Setting
6.5 Display Setting

Select the languages of parameters according to the unit of some
parameters which need to be modified.
1. Entering into Display Setting
Click "Display" after entering into "Setting" interface as shown in Figure
6-10.
48
Chapter 6 Settings
Figure 6-10 Display Modification Interface

2. Display Modification Setting
The operator can select different parameters units, English parameter
language and reference value order etc. Click the "Display--General" button to
select the desired display settings, the results on screen and those printed out
will also change.
3. Save and Exit
Click SAVE, the save dialog box will display (see figure 6-11). Select Save
to save the modification of display settings and back to the corresponding
interface, and Cancel is contrary.
Figure 6-11 save dialog box
6.6 Print Setting

User can choose "Printer Type", "Print Format" and "Auto Print" according
to the specific circumstances, and input the corresponding hospital name to
the “Printer Title”.
1. Entering into Print Setting
49
Chapter 6 Settings
Click “Print” in the Setup interface and enter the Print Setting interface.
(See figure 6-12).
Figure 6-12 Print Setting
2. Setting Print Options

In Print Setting, operator can select printer type, print format, auto print
and input hospital name in “print title”.
3. Save and Exit
to save the print settings and back to the corresponding interface, and Cancel
is contrary.
Figure 6-13 save dialog box
50
Chapter 6 Settings
6.7 Transfer Setting

In Transfer Setting, operator can set the port number, IP, baud rate, data
bit, stop bit and parity bit of the external communication port.
1. Entering into Transfer Setting
Select Transmit in the Setup interface, then enter the Transfer Setting
interface (see figure 6-14)
Figure 6-14 Transfer Setting Interface
2. Modify Transport Protocols

Operator can modify the port number, IP, baud rate, data bit, stop bit and
parity bit of the communication port. If the auto-trans are “ON”, the test results
will transmit from the communication port automatically.
CAUTION
¾ Transfer setting is already set before delivery. As a rule, there is no need to
reset, or the data transmission will be affected. Necessary modification
should be done under the guidance of NeoMedica engineer.
3. Save and Exit
to save the modification of transfer settings and back to the corresponding
interface, and Cancel is contrary.
51
Chapter 6 Settings
Figure 6-15 save setting

NOTE
¾ Click SAVE and select Save to save the settings after modification,
otherwise it will lose.
6.8 Group Parameters

To monitor abnormal test parameters of blood samples, it is essential for
the operator to set normal ranges of the parameters according to laboratorial
or clinical requirement. Information or indication will be given if the test values
exceed the range. The analyzer provides the limit of 24 parameters, any
results exceeding the range will be marked H (High) or L (Low). H means the
results are higher than the upper limits, while L means the results are lower
than the lower limits.
CAUTION
¾ The shift in parameter limit may cause changes in abnormal indication of
hematology index. Please confirm the necessity for changing.
6.8.1 Limit Review

At Limit setting interface, operator can input proper parameter limits or use
the default limits. Default limits are different depending on the patient group.
Figure 6-16 depicts the General group limits, and figure 6-17 depicts the User1
group limits.
52
Chapter 6 Settings
Figure 6-16 Limit Setting
Figure 6-17 Limit Setting
53
Chapter 6 Settings
6.8.2 Limit Modification

Operate as follows to modify the parameter limit:
1. Click the triangle on the right side of Group to select the group that needs
to be modified.
2. Select the lower or upper limit of parameters need modification. Move the
cursor into edit box, press “Backspace” on the keyboard to delete raw data
and input the new lower or upper limit.
3. Click SAVE, the save dialog box will display (see figure 6-20). Select NO to
cancel and go back to browsing status of parameters Select YES to save
the modification and back to the corresponding interface.
6.9 User Management

Operator should login the system with identity to operate the routine check.
Only the administrator can modify user setting, so message erection of the
operator is necessary.
1. Entering User Management Setting
Click User in the Setup interface, then enter user management interface. (See
figure 6-19).
Figure 6-19 User ManagementAdd User
54
Chapter 6 Settings
Input the user’s name, select Permission, set password (default password
is null) and click “Add” to add the new user. (See figure 6-20).
Figure 6-20 Add User

2. Modify User
Click the user and choose “Modify” to modify the User name, group and
password.
3. Delete User
Select and click Del. to delete the user. Then select OK or Cancel to
confirm whether to delete the user or not. (See figure 6-21).
Figure 6-21 delete user
6.10 Permission
In order to guarantee the proper use, it is necessary for the administrator
to only give partial permissions to other operators, such as only allow
55
Chapter 6 Settings
operators to query and count data, but cannot delete.

Select certain permissions in the picture below. (See figure 6-22).
Figure 6-22 Permission Setting
56
Chapter7 Daily Operation
7.1 Overview
This chapter describes the whole procedures of daily operation from
startup to shutoff, and explains the process of different modes of sample
analysis in detail.
Daily Operation Flow Chart as follows:
Preparations
Startup
Quality Control
Specimen Preparation
Data Input
Sample Count
Result Query and Output
Statistic
Shutoff
CAUTION
¾ The analyzer must be operated by medical inspection professionals or
trained doctors, technicians.
7.2 Preparations
Check the analyzer as the following steps before startup to ensure the system
is ready.
57
Chapter 7 Daily Operation
1. Check the Waste Container

The waste should be processed properly and cleaned up before startup every
day.
2. Check the Reagents, Tubes and Powers
Ensure diluent, Detergent, detergent and sheath meet the test.
Ensure the tubes of reagents and waste connected well and without bending.
Ensure the power plugs of instrument, computer and outlet connection is
reliable.
3. Check the Printer
Ensure printing paper is sufficient and the installation is proper.
Ensure the power is on and the cable has been connected with the analyzer
and the computer properly.
4. Check the Mouse and the Keyboard
Ensure the mouse and the keyboard has been connected with the computer.
WARNING
¾ All clinical specimens, controls, calibrators and waste with potentially
infectious hazard. The operator should comply with the safe operation
provisions in laboratory and wear personal protective equipment (lab coats,
gloves etc.) when handling these materials.
7.3 Startup
Turn on the power switch on the right panel, then the status indicator on
the front panel will be orange. The analyzer will automatically detect the
operation of the components when self-checking and initialization after loading,
and then rinse the flow system. It takes about 3 minutes before entering the
Blood Cell Count interface (See Figure 7-1) after initialization.
58
Figure 7-1 Blood Cell Count interface
After startup, background counting should be performed before blood

sample test. Analyzer can be set to run background counting automatically
after startup. Consult Chapter 6 for the instrument settings. The range of
background is listed in Table 7-1.
Table 7-1 Range of background
Parameter Acceptable range
WBC ≤0.20x109/L
RBC ≤0.02x1012/L
HGB ≤1g/L
PLT ≤10.0x109/L
If the background result is out of this range, repeat the above procedures until
it is in this range. If the results are still out of this range after repeat five times,
please refer to please refer to 11.4.2 for Troubleshooting for help.
7.4 Quality Control

Quality Control should be performed before daily test to ensure accuracy of the
results. Please refer to Chapter 8 Quality Control.
59
7.5 Collection of Blood Samples
WARNING
¾ Considering all the clinical specimens, controls and calibrators etc. that
contain human blood or serum as being potentially infectious, wear lab
coats, gloves and safety glasses and follow required laboratory or clinical
procedures when handling these materials.
¾ Do not directly contact blood samples, controls and calibrators, and follow
required procedures when disposing.
CAUTION
¾ Blood collection and disposal should be performed according to the local
and national environmental regulations or laboratory’s requirements.
¾ Ensure the whole procedure of blood collection is clean and
contamination-free. All specimens must be properly collected in tubes
containing the EDTA (EDTA-K2·2H2O) anticoagulant.
¾ Do not shake the sample tube violently.
¾ Venous blood can only be stored for 4 hours at room temperature.
NeoMedica recommends the blood sample be kept at the temperature
between 2-8°C for longer storage.
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7.5.1 Whole blood collection

Collect whole blood sample through vein-puncture and store it in a clean
sample tube with EDTA-K2·2H2O, which can keep the configuration of WBC,
RBC and avoid platelets aggregation. Gently shake the tube 5~10 times and
ensure mix well.
The following anticoagulants are commonly used in whole blood collection:
1. Heparin:
Lead to cell aggregation and change the cytoplasm’s color of
Romanowsky staining. The concentration of high heparin > 7.5UL/
capillary will lead to increase in HCT and MCV.
2. Sodium citrate:
Since sodium citrate is liquid, it may be diluted to 10/11 of the original in
the tube filled with whole blood. This anticoagulant is used for agglutination
when a suspect EDTA causes spurious thrombocytopenia.
3. ACD and CPDA:
Most widely used in cell Concentration (especially platelet concentrates),
usually not used for cell counts.
4. EDTA:
In the salt of EDTA, use EDTA K2（United States and Japan）and EDTA K3
（United States and Europe）,sometimes NA2EDTA. And EDTA K2,
EDTA K3 which recommend by ISCH in1993 are most widely used in the
blood test of the world. But other EDTA salts can also be used. EDTA
could lead to Pseudo-thrombocytopenia through Platelet aggregation.
(Incidence is about 1/800)
5. Fluoride:
Use before EDTA. Without side effects according to the survey
7.5.2 Pre-dilution sample preparation

Pre-dilution sample preparation procedures as follow:
1． Set the current test mode to Dilution mode under the “Count” interface, as
shown in figure 7-2:
Figure7-2 Mode Switch operations
2． In the process of whole blood switch to dilution mode, the instrument will
be cleaned.
61
3． Take a clean test tube under the aspiration probe. And then press the
drainage button under the counting interface to discharge 150uL diluent
along the tube wall into the test tube, in order to avoid produce bubbles or
spills.
4． Please quickly inject collected 20uL peripheral blood into the test tube and
blending with the diluent.
CAUTION
¾ The collected diluent should avoid mixed with dust, otherwise it will
produce analytical error.
¾ Peripheral blood and diluent after full reaction, should be placed for 3
minutes, and then only after blending again that can do the analyze.
¾ Ensure that the sample has been analyzed within 30 minutes after dilution;
otherwise the analysis results are not reliable.
¾ The sample placed after a period of time should be blending to anew for
analysis.
¾ Each laboratory should according to their respective sample number,
sampling method and the technical level to evaluate the stability of the
results under the pre-dilution mode.
7.5.3 Sample stability

Better to use fresh whole blood. ICSH (International Committee for
Standardization of Hematology) defined fresh blood as: samples processed
within 4 hours after collecting. When whole blood samples are thoroughly
mixed, placed in EDTA-tubes, and tested within 8 hours after collecting, the
accuracy of each parameter will be highest. Test samples within 5 to
20minutes or over 8 hours, the WBC volume distribution will offset.
7.6 Information Input

Click Data in the interface to input the detail information about the sample,
and NeoMedica recommends operator to input the detail information before
sample analysis. (See figure 7-3
62
Figure7-3 Data Input 1
Figure7-3 Data Input 2
63
Click “Ctrl+Shift” on the keyboard to select Input Method.

Name: Input English characters, letters and numbers.
Sex: Select male or female. If not, default as blank.
Age: Select Year, Month and Day.
Blood Type: Select A, B, O, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-.
O Rh+, O Rh-. If not selected, default as blank.
Group: Select Auto, Man, Woman, Child, New-born, General, Custom 1,
Custom 2, Custom3.
If Auto is selected, the reference values are listed as Table 7-2.
Table 7-2 Reference Value
Reference Value Age(Year) Sex
General NO input Blank, M,F
General ≥16 Blank
Man ≥16 M
Woman ≥16 F
Child >1 and ＜16 Blank, M,F
Baby <1 Blank, M,F
ID: The ID number is in range from 00000000 to 99999999. If no ID input, the

ID of current sample will be automatically added follow the last one.
Case ID: Input the sample number.
Bed No.: Input bed No. of patient.
Department: Input department name or code of operator.
Checker: Input checker’s name or code.
Sender: Input sender’s name or code.
Assessor: Input assessor’s name or code.
NOTE
¾ The ID number is set to 0 only under Background Count. The blood
sample ID CAN NOT be 0.
CAUTION
¾ Each sample has a corresponding identification number. Do not confuse.
7.7 Sample Counting
7.7.1 Mode
Under the "count" interface, click the "▽" button shown below, select the
desired operating mode.
64
Figure 7-4 Mode Switch

After selected the required working mode, click on "ok" to switch into the
corresponding work mode.
NOTE:
¾ User can choose CBC if he wants whole blood and pre-dilution modes.
CBC mode is only available for counting and without differentials. The
counting result includes 18 parameters and the diagrams of RBC and PLT.
¾ “CBC+5Diff+RRBC"--- For counting after dissolving the indissolvable red
blood cells. It is suggested that when RRBC? alarms, switch counting
mode to CBC+5Diff+RRBC, and then run counting again so as to eliminate
the interference of white blood cell coning from the indissolvable red blood
cells. If WBC total number is far less than that of the first counting, it shows
that this specimen contains indissolvable red blood cells.
7.7.2 Counting and Analysis
WARNING
¾ The sharp sample needle contains residues of clinical specimens, controls
or calibrators probably have potential infectivity. Do not directly contact the
sample probe.
NOTE
¾ Do not reuse disposables.
¾ Ensure the inputted ID number correspond with the sample.
CAUTION
¾ Do not open the front panel after start counting.
7.8 Data Query and Output

After each counting, the results are automatically saved in a database that
could store at least 200,000 results include 34 parameters (2 scatter diagrams,
2 histograms, 2 Three-dimensional plots).Operator could review all of the
results, scatter diagrams and histograms that store in the database through
query and statistic.
65
7.8.1 Data Query

Click “Data”-“Query” at the “Count” interface, and then enter
the query interface. (See figure 7-5)
Figure 7-5 Data Query

The operator can quickly query the results of specimens according to the
query condition such as date, ID, name, sex, age, blood type etc. (Combined
Query is available).Take ID as an example, to query the results between ID
1000 and ID 1002, click the box in the left of ID and input 1000 to 1002, click
Query, the needed results will be displayed. (See Figure 7-6)
66
Figure 7-6 Condition Query
67
7.8.2 Data Selection

Click the result needed, the row of result will be highlighted to identify
being selected. Figure 7-7 is the sample record of number 1040.
Figure 7-7 Select Single Result
68
Select single data (such as No.1040), click “Detail” (or double-click

directly), then the detail information of the datum will be displayed.
Figure 7-8 Query Detail Information
69
Press and hold the "Ctrl" or "Shift" to select the desired data, the selected
data will show highlight blue, as shown in figure 7-9
Figure 7-9 select multiple data
70
7.8.3 Data Deletion

After processing plenty of samples, it is necessary to clean up or delete
the mass data stored in the analyzer according to the requirement of the
operator.
NOTE
¾ Be aware that once the data are deleted, they can NOT be recovered.
Please operate with caution.
7.8.4 Repeatability
Check the precision of each parameter of selected sample result,
including Mean, SD and CV%. The calculation formulas are as follows:
N is the number of samples selected, Xi is the results of i times for the

specified parameters.
Selected the results that need to be calculated CV, click Prec. into the
interface as figure 7-10, and check the precision.
71
Figure7-10 Repeatability computing interfaces
NOTE
¾ Only can compute the repeatability of 10 specimens.
¾ “***”means invalid. If some parameters of selected sample are invalid, the
precision is invalid too.
7.8.5 Data Comparison

The operator can view the selected sample data contrast diagram, after
you choose the sample results, click “Compare” button to enter the “Data
Comparison Interface”, to view the results of the selected sample data
comparison, as shown in figure 7-11.
72
Figure7-13 Data Comparison Interface
7.9 Reticulocyte Analysis

The reticulocyte package software enables the operator of the NCC-51
system to analyze a whole blood specimen for reticulocytes. The reticulocyte
specimen is prepared by using reticulocyte reagent to produce a diluted,
stained sample.
Press Retc to start reticulocyte analysis. The analysis screen is shown
below.
73
Figure 7-12 Reticulocyte Analysis

The prepared specimen run with the reticulocyte package on the NCC-51
system will measure results as a reticulocyte percentage. The reticulocyte
absolute number is automatically calculated when the RBC value is made
available from the Standard Hematology Data Log or entered by the operator.
The Immature Reticulocyte Fraction (IRF) is calculated from the
Reticulocyte % and displayed below the Reticulocyte absolute number.
7.9.1 Principles of Operation

Reticulocytes are defined by the National Committee for Clinical
Laboratory Standards (NCCLS) as transitional red cells, between nucleated
red cells and the so-called mature erythrocytes. In contrast to mature RBCs,
reticulocytes contain ribosomal RNA. This RNA can be seen with certain
supravital, cationic dyes that simultaneously stain and precipitate the polyanion
to form a network or reticulum. The NCC-51 system reticulocyte method uses
the thiazine dye New Methylene Blue N. The reticulocyte assay is performed in
the WOC channel of the instrument. Sample preparation is performed
manually by diluting 20 µl of blood into a tube of NeoMedica Reticulocyte
Reagent. At room temperature, staining of reticulum is complete within
approximately 15 minutes. The stained sample is aspirated in the Open Mode.
After the stained sample is aspirated, it is diluted approximately 50-fold with
74
Sheath Reagent. Once diluted with Sheath, the RBCs sphere due to the
influence of the nonionic detergent incorporated into the staining solution.
Sphering is necessary to eliminate optical orientational noise that would
otherwise be introduced into the scatter measurements. The usual lytic action
of the Sheath is prevented by electrolytes contained in the staining solution
and the lack of the usual incubation period used in this channel during WBC
analysis. In addition, the high New Methylene Blue concentration in the
staining reagent exerts a stabilizing effect on RBCs.
During data acquisition, 10 degree and 90 degree scatter are collected for
up to 30,000 events. The 0 degree threshold is set high enough to exclude
most platelets. Histogram data are used to differentiate reticulocytes, mature
RBCs, platelet clumps, and nucleated cells. Reticulocytes have 10 degree
scatter that are similar to the scatter for mature RBCs, but differ from them by
exhibiting greater 90 degree scatter. Reticulocytes are reported in percent. The
instrument will automatically calculate the reticulocyte Absolute value if an
RBC count is entered. The RBC value may be obtained from the Standard
Hematology Data Log, or it may be entered by the operator directly on screen.
Immature reticulocytes contain more RNA and absorb more stain than
mature reticulocytes; therefore, they exhibit greater 90 degree scatter. On the
NCC-51, immature reticulocytes are classified as the population of
reticulocytes that exceed a predetermined scatter threshold. Consequently, it
is possible to determine the Immature Reticulocyte Fraction (IRF) from the
scatter measurements.
The IRF was initially designated as the Reticulocyte Maturation Index

(RMI), and defined by NCCLS H44-A1 as a quantitative expression of the
relative maturation of the reticulocytes in the observed reticulum in New
Methylene blue-stained preparations. However, these quantitative visual
measurements of reticulocyte maturation have been little used due to the
subjectivity and imprecision of the manual analysis. Since automated
reticulocyte methods allow the enumeration of immature reticulocytes as a
subfraction of the total reticulocyte population, the preferred nomenclature is
Immature Reticulocyte Fraction (IRF). The immature reticulocytes are then
reported as a fraction (or percent) of the reticulocytes.
The clinical utility of the IRF is widely recognized as follows:

z Monitor hemopoietic regeneration after bone marrow transplant,
hemopoietic stem cell transplantation, or intensive chemotherapy
z Monitor bone marrow toxic insults from drugs (for example, AZT)
z Monitor erythropoietin therapy in renal failure, AIDS, infants,
myelodysplastic syndromes, and blood donations
z Classify anemia
75
z Monitor efficacy of anemia therapy (Fe, B12, Folate)
7.9.2 Reticulocyte Sample Preparation
CAUTION
¾ Add 20uL blood samples to be tested to reticulocyte dye test tube (3.7 mL),
and place it at about 15 ° C ~ 30 ° C for 15 to 30 minutes after mixing.
¾ The accuracy of the results will be affected more than 2 hours.
NOTE
¾ Avoid contacting with skin and clothing when using the reticulocyte reagent,
since it contains new methylene blue which will contaminate skin, clothing
and many other surfaces.
7.9.3 Reticulocyte Test

Place the prepared reticulocyte samples into the single sampler, then the
dialog shown in Figure 7-13 will pop up. Operator inputs the serial number and
RBC value, then click Run, that the reticulocyte test begins, as shown in Figure
7-14
Figure7-13 Reticulocyte Test Screen
76
Figure 7-14 Process of Reticulocyte Test
77
7.10 Statistic
On Blood Cell Count Interface, click “ ” button, and then choose

“Statistics” to enter statistics interface (See Figure 7-15). Operation procedure
is as follows:
Figure 7-15 Statistics interface
（1） In the box of statistic date, click to select Start Date and End Date,
then click OK.(see figure 7-16)
Figure 7-16 Select Data
（2） Select types such as Department and Sender in the Statistics Type box,
and then all items selected will be displayed in the middle list box.
78
（3） Select statistic item (or multi-select), click “Cal”, then the desired data
will be displayed in the right list.
（4） Click “ ” to return Blood Cell Count Interface.

（5） Click Print to print the statistics.
7.11 Shutoff
Shutoff procedure should be performed after finishing all the tests and
before turning off the power. Clean the counting chambers and related tubes. If
continuously use the analyzer or finishing today’s test, shutoff procedure
should be performed at least once every 24 hours.
The procedures of Shutoff as follow:
1. Click “Exit” on the main interface;
2. Pop-up close confirmation dialog;
3. Check whether the procedure of shutoff is finished, the close dialog box is
shown or not.
4. Turn off the power of the instrument and the computer.
CAUTION
¾ May be lead to data loss and abnormal boot, if the shutoff procedures
are not performed.
79
Chapter 8 Quality Control
8.1 Overview
It’ probably leads to unreliable results for a long time use. In order to
maintain the analyzer precision and eliminate system errors, it’s necessary to
perform quality control.
It’s better to use low, normal and high controls to perform quality control
every day or using normal control at least. When using control of new lot,
please combine it with the existing controls for 5 days, twice per day, and the
results should be within the range of parameters of the control instruction.
In the following conditions, perform quality control with controls
recommended by NeoMedica:
z After daily start-up procedures completed
z The reagent lot number changed
z After calibration
z After maintenance, or component replacement
z In accordance with the laboratory or clinical QC protocol
z In suspicion of abnormal parameter value
WARNING
¾ Considering all the clinical specimens, controls and calibrators etc. that
coats, gloves and safety glasses and follow required laboratorial or clinical
NOTE
¾ Ensure to perform the following procedure before using the control
removed from the refrigerator:
1. Leave it for 15 minutes to reach room temperature (18-35°C).
2. Rub the vial for 10 to 15 times;
3. And gently invert the vial 1for 0 to 15 times;
4. Ensure that the contents of vial are completely suspended by
inverting the vial and viewing the bottom. Repeat step 2 and 3 for 8
times, or for 2 minutes, until completely suspended.
80
8.2 Quality Control Options

This analyzer provides four quality control methods, L - J quality control
mode, X - B quality control mode, X -R quality control mode and X quality
control mode.
(1) L-J QC
L-J QC (Levey-Jennings graph) is a simple and visual QC method with
which operator can draw QC value directly on graph after getting the Mean, SD
and CV. Mean, SD and CV are derived from following formulas:
(2) X-R QC
In X-R QC method, X indicates mean value, R indicates range of value. X
graph is mainly used to judge that if the mean value falls in required level. R
graph is mainly used to judge that if the range of value falls in required level.
(3) X QC
X QC is the variation of X-R QC; they have the same basic principle. The
difference is that the control dot in X graph indicates the mean value of two
values other than one value. On this foundation, it calculates the Mean, SD
and CV.
(4) X-B QC
X-B QC is a moving average method which is first promoted in 1970s’. It’s
based on the principle that, RBC count is varied due to the concentration of
dilution, human blood pathology and technical factor, but the hemoglobin
content in specific unit is hardly interfered by those preceding factors.
According to this characteristic, quality control of the samples is being done by
surveying the value of MCV, MCH, and MCHC.
81
8.3 QC Mode Selection

Click QC in main interface, pop up interface as figure 8-1:
Figure 8-1 QC Mode Select
System offers four quality control options: L-J QC, X-B QC, X-R QC and X
QC. Select the mode and click to enter corresponding interface.
8.4 L-J QC
In L-J QC, the operator could perform QC with 20 test parameters at most.
Considering the different needs, selecting partial parameters for QC is
available. 3 QC documents of high, normal and low are provided for saving.
8.4.1 L-J QC Edit

In different interfaces, click QC Edit enter corresponding edit interface. In
L-J QC interface, click L-J QC to enter edit interface. Input control lot NO.,
expiry data and level, then input desired assay and limit according to the
control instruction.(see figure 8-2)
NOTE
¾ The limit should not be more than 40% of assay, or the limit cannot be
saved in database.
82
Figure 8-2 L-J QC Edit Interface 1
Figure 8-2 L-J QC Edit Interface 2
Click OK after editing, the dialog box about whether to save the edit result
will display.(see figure 8-3)
83
8.4.2 L-J QC Run

In L-J QC interface click QC Run, enter the interface as figure 8-4.
Figure 8-4 L-J QC Run
84
8.4.3 L-J QC Graph Analysis

In L-J QC interface click QC Analysis, enter graph analysis interface as
figure 8-5:
Figure 8-5 L-J QC Graph Analysis
8.4.4 L-J QC Data Query

In the L-J QC interface, click QC Query, enter data query interface as
figure 8-6:
Figure 8-6 L-J QC Query Interface
85
8.5 X-B QC
X-B QC is different to others, with which the systems can only edit three
parameters: MCV, MCH, and MCHC. It is a QC without controls and a means
of monitoring instrument like controls, but they can’t substitute each other.
NOTE
¾ Recommend using X-B QC, when the quantity of samples is more than
100.
¾ X-B QC is for the use of random sample, not for classification samples.
¾ Observed the trend of QC result in reference range which made up by
reference, low and high limit.
8.5.1 X-B QC Edit

Before QC analysis, operator should finish the QC edit as follow:
1. In the main interface, click QC, and then click X-B to enter X-B QC
interface.(see figure 8-7)
Figure 8-7 X-B QC Interface

2. Input the assay and limit of parameters that require for quality control.
3. Input the number of required samples when calculate a dot of X-B QC. The
range of selection is 20 to 200; NeoMedica recommends the number is 20.
4. In the X-B QC interface, click “On” in the X-B Edit to open the X-B mode.
86
8.5.2 X-B QC Run

When finish QC edit, click “Count” to operate quality control. The system
will automatically operate a QC calculation after analyzing, and get a dot that
correspond with each reference of X-B QC and save it in X-B QC graph and
X-B QC list.
8.5.3 X-B QC Graph Analysis

Operator can review QC results of three parameters through graphs. After
the count of group samples completed, the results of MCV, MCH and MCHC
will depict a dot on the graph. For example, the “X-B QC” is ON and “Batch
No.” is 20, then after the subsequent 20 counts, the system will calculate a X-B
QC value and a corresponding control dot which will display on the graph.
There are three graphs of MCV, MCH and MCHC. The graphs will update
at once after each QC counting. QC results are arranged in graphs according
to storage time. The latest is on the left side and its serial number is 1.
QC Graph instruction:
1、 Graph abscissa indicates QC run times, ordinate indicates QC result.
2、 Every parameter graph can display at most 31 dots.
3、 Every parameter graph’s upper transverse line means assay plus limit.
4、 Every parameter graph’s lower transverse line means assay subtract
limit.
5、 The 3 values on the left side of parameter graph mean:
a) upper limit —— assay + limit;
b) middle line —— assay;
c) lower limit —— assay - limit.
If the control dot falls in the area between upper and lower lines of the
corresponding graph, it means the dot is under control range; If not, the dot is
not under control range.(see figure 8-8)
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Figure 8-8 X-B QC Graph
8.6 X-R QC
X-R QC needs controls. If run a background QC, the system will alarm QC
result is invalid.
8.6.1 X-R QC Edit

Before QC analysis, operator should finish QC Edit as follows:
1. At main interface, click “QC”, then click “X-R QC”, enter X-R QC Edit/Run
interface. (See figure 8-9).
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Figure 8-9 QC edit/run 1
Figure 8-9 QC edit/run 2
2. Select corresponding level: low 1, low 2, low 3; normal 1, normal 2, normal

3; High 1, High 2, High 3.
3. Input lot NO., and select expiry date according to control instruction.
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8.6.2 X-R QC Run

When finishing QC Edit, place the prepared control in Emerge place, the
analyzer will automatically aspirate the controls to start analysis.
In QC interface, system displays two control results, and calculates the
mean and range automatically after finishing the second QC count.
8.6.3 X-R QC Graph Analysis

X-R QC is similar to X QC; operator can review QC results of 24
parameters through QC graphs. At X-R QC interface, click QC Analysis, enter
graph analysis interface. (See figure 8-10).
Figure 8-10 X-R QC graphs
X-R QC is different from X QC is, the dot on X-R QC Graph indicates

mean value or range of two QC results. The system cannot display low, normal
and high control graphs simultaneously in one interface, please select Level to
change.
In X-R QC interface, there are X graph and R graph. X graph displays the
mean value dot while the R graph displays the range dot.
If operator selects group 1 of low level to perform QC twice, the dot
correspond with mean will be within X graph which correspond with low value 1.
It also fits for the dots of other groups—the dot correspond with range is within
corresponding R graph.
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QC results are arranged in QC graph according to storage time, the latest

is on the left side and its serial number is 1.
X graph instruction:
3、 Every parameter graph’s middle transverse line indicates X (mean
value of QC results).
4、 Every parameter graph’s upper transverse line means X upper limit＝X
＋A×R.
5、 Every parameter graph’s lower transverse line means X lower limit＝X
－A×R.
d) upper limit —— X upper limit＝X＋A×R
e) middle line —— X
f) lower limit —— X lower limit＝X－A×R
R graph instruction:
3、 Every parameter graph’s middle transverse line indicates R (mean
value of QC result range).
4、 Every parameter graph’s upper transverse line means R upper limit＝
B×R.
5、 Every parameter graph’s lower transverse line means R lower limit＝
C×R.
g) upper limit —— R upper limit＝B×R
h) middle line —— R
i) lower limit —— R lower limit＝C×R
corresponding graph, it means the dot is under control range. If not, the dot is
not under control range.
8.6.4 X-R QC Data Query

When finish QC count, operator can review QC result of 24 parameters
through QC Query. Click QC Query to enter the interface as figure 8-11.
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Figure 8-11 X-R QC Query Interface
Click Pgprv or Pgnex to review the data. Operator could review 31 items
data at most. Click D_All to delete all data.
The difference to X and L-J QC Query is: each page in the X-R QC Query
interface display three QC results that include mean value and range. But the
first page of the first two columns is total mean and average range in the X-R
QC Query.
The QC data would update after running two new controls.
8.7 X QC
In X QC, analyzer should aspirate control to operate QC. The operator
could perform QC with 20 test parameters. Considering the different needs,
selecting partial parameters for QC is available. 3 QC documents of high,
normal and low are provided for saving.
8.7.1 X QC Edit
Before QC analysis, operator should finish QC Edit as the follows:
1. In the main interface, click “QC”, then click “X QC”, enter X QC Edit
interface.(see figure 8-12)
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Figure 8-12 X QC Edit Interface 1
Figure 8-12 X QC Edit Interface 2

2. Select corresponding level: low 1, low 2, low 3; normal 1, normal 2, normal
3; High 1, High 2, High 3.
3. Input lot NO., and select expiry date according to control instruction.
4. Input assay and limit value according to control instruction.
After QC Edit, click “Save”, the dialog box that whether to save the result or not
will display. (See figure 8-14).
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Figure 8-13 save settings
8.7.2 X QC Run
In X QC interface, click QC Run, enter the interface as figure 8-14:
Figure 8-14 X QC Run Interface

Select the level, lot No. and expiry date that X QC Edit selected.
In QC interface, system displays two control results, and calculates the
mean value automatically after finishing the second QC count. The column of
mean value show the mean value, the column of reference range show
reference range that user input in the QC Edit.
In the QC Run interface, place the prepared control in Emerge place; the
analyzer will automatically aspirate the controls to start analysis. If the
reference value of current group is empty, the system will alarm and cannot run
the QC count. Back to QC edit interface, then input QC reference value and
limit of deviation for running QC count. If run a background QC, the system will
alarm QC result is invalid.
8.7.3 X QC Graph Analysis

After QC Run, operator can review QC results of 20 parameters through
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QC Graph. In X QC interface, click QC Analysis, then enter the interface as

figure 8-15:
Figure 8-15 X QC Analysis
The dot on the X QC Graph indicates mean value of two QC results.

There are low, normal and high graphs. If select group 1 and low level to run a
control sample, the control dot will present in low 1 graph. Other selections
will present in corresponding graph.
QC results are arranged in graphs according to storage time. The latest is
on the left side and its serial number is 1.
QC graph instruction:
3、 Every parameter graph’s upper transverse line means assay plus limit.
4、 Every parameter graph’s lower transverse line means assay subtract
limit.
j) upper limit —— assay + limit
k) middle line —— assay
l) lower limit —— assay - limit
corresponding graph, it means the dot is under control range. If not, the dot is
not under control range.
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Chapter 9 Calibration
9.1 Overview
Analyzer is detected and calibrated at the factory just prior to shipment.
For some reasons the result may be a little out of the range. Calibration is to
insure the accuracy of results. Calibration is a process to standardize the
analyzer by its deviation of value and parameter, calibration factor.
The instrument provides three calibration modes: Calibrator Calibration,
Whole Blood Calibration and Manual Calibration.
CAUTION
¾ Only calibrators recommended by NeoMedica can be used to accomplish
the calibration.
¾ Follow the use instruction to store and use calibrator.
¾ Check if the container is broken or cracked before using the calibrator.
¾ Make sure the calibrators are brought to room temperature and well mixed
slowly before use.
¾ Make sure the calibrators are within the expiry date.
¾ Make sure the analyzer without problem and precision meet the
requirement before calibration.
¾ Never apply to the laboratory or clinic use unless all the parameters are
accurately calibrated.
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CAUTION
¾ Slowly remove a vial of blood calibrator from refrigerator, and warm to
room temperature by rubbing.
¾ Ensure the contents of a veil are completely suspended by inverting the
veil 30 times at least.
9.2 Calculate Frequency

To ensure precision and obtain reliable test results, the parameters(WBC，
RBC，PLT，HGB and MCV) should be calibrated in the following situations:
(1) Working environment changes greatly;
(2) One or multiple parameters’ test results are moving;
(3) Any major component that affect the measurement is replaced;
(4) For long time no use;
(5) Requirement of the laboratory or the clinic;
(6) The reagent has been replaced;
(7) The analyzer presents deviation when running quality control.
MCV and HCT are relative parameters to each other, thus one can be obtained
from given value of the other. Only MCV can be calibrated by the analyzer.
Usually the manufacturer will give the value for MCV, HCT at the same time.
WARNING
¾ Considering all the clinic specimens, controls and calibrators ect that
coats, gloves and safety glasses, and follow require laboratory or clinic
9.3 Preparation for Calibration

Before calibration, inspect the analyzer as the following requirements:
(1)Ensure the adequate reagents are in the shelf life and uncontaminated.
(2)Run a background test and make sure the results are accordance with table
9-1 background range.
Table 9-1 background range
Parameter Range
WBC ≤0.20x109/L
RBC ≤0.02x1012/L
HGB ≤1g/L
PLT ≤10.0x109/L
(3)The analyzer no errors;
(4)Verify the precision of the analyzer. At Hematology Analyzer, run a normal
control for 11 times, query the results from second to eleventh result precision
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in Query. Make sure the CVs are accordance with table 9-2 precision;
Table 9-2 Precision

Parameter Precision（CV/%） Range
WBC ≤1.5% 4.0×10 /L ~ 15.0×109/L
9
RBC ≤1.0% 3.00×1012/L ~ 6.00×1012/L

HGB ≤1.5% 100 g/L ~ 180g/L
HCT ≤2.0% 35% ~ 50%
MCV ≤1.0% 70fL ~ 120fL
PLT ≤4.0% 100×109/L ~ 500×109/L
(5)Carryover is determined by running high and low controls of WBC, RBC,

HGB and PLT. The high control is run in triplicate follow by three low control
running cycles. The carryover is calculated by the following formula and result
is confirmed to table 9-3.
Table 9-3 Carryover

Parameter Result
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
PLT ≤0.5%
9.4 Calibration Mode
9.4.1 Calibrated Calibration

In main interface, click “Cal”, then select calibrator calibration mode into the
interface as figure 9-1. And calibrate as follows：
1. Input lot NO. and expiry date according to the calibrator instruction;
2. Select the parameter needed. Default select all;
3. Input the reference value according to the calibrator instruction and the
reference value of parameters do not need to be calibrated is blank.
4. Press “Start Calibrate Counting” button to start calibrate. The analyzer
could automatically calculate the mean value of 11 tests at most.
NeoMedica recommend testing 3 to 5 times at least.
5. The new calibration coefficient is calculated according to the reference
value of calibrators and mean. Click Save to save the new calibration
coefficient that calculated by system automatically.
6. Click Print to print the new calibration coefficient; and click Back to exit
98
system calibration.
Figure 9-1 Calibrator Calibration Mode 1
99
NOTE
¾ The analyzer can calibrate a certain or all parameters of WIC，WOC，RBC，
100
HGB，MCV，MPV, RDW_CV, RDW_SD, PLT，PDW.

¾ If you do not press the save button to save the data before press the return
push-button, the data will be lost.
7. Validation of Calibrated coefficient

After calibration, NeoMedica recommend to follow the steps below to validate
the calibrated coefficients:
(1) Test the calibrators three times, and check whether the results are within
the allowed range.
(2) Analyze high, normal and low controls, and each control should be tested
for three times at least and check whether the results are within the
allowed range.
(3) Analyze three normal fresh blood samples, three times for each at least.
And check whether the results are within the allowed range.
The principles of new calibration value:
z Mean value=(value1+value2+value3+value4)/4
z New calibration value=(reference/mean value)×former calibration
value
z If the new calibration value<70%, consider it equals to 70%; if the new
calibration value>130%, consider it equals to 130%
For example: the reference value of PLT of the calibrator is 220, current
calibration value is 103% and mean value is 230, thus the new calibration
value is;
New calibration value =103%×220/230
=98.52%
NOTE
¾ The calibration coefficient is allowed in the range of 70%~130%, if the
test values exceed the limit; the critical value in the limit range should
be selected as the new coefficient for calibration. And in that case,
operator should find out reasons and calibrate again.
9.4.2 Whole Blood Calibration

In main interface, click Cal, then select Blood Cal, enter the interface
as the figure 9-2.
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Figure 9-2 Whole Blood Calibration 1

Calibrate the analyzer as follows:
(1) Select the desired parameters and sample No..
(2) Prepare 3 to 5 normal whole blood samples according to the
collection of blood sample in Chapter 7.
(3) Use 3~5 prepared samples and test each of them for three times at least to
get the mean. Consider the mean or the data that obtained through the
reference method as reference value.
(4) Press “Start Calibrate Counting” button to start calibrate, the analyzer
could automatically calculate the mean value of 11 tests at most.
NeoMedica recommend testing 3 to 5 times at least)
(5)Repeat steps 4 until obtain more than three calibration coefficients. The
system will automatically calculate the mean value of each calibration
coefficient.
(6) Click Save to save the new calibration coefficient.
(7) Click Print to print the new calibration coefficient; Click Back to exit the
system calibration.
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103
(1) Test the calibrators three times at least, and check whether the results are
within the allowed range.
for three times at least and check whether the results are within the
allowed range.
9.4.3 Manual Calibration

Following the steps below to operate manual calibration:
1. Operator chooses whole blood single sampling mode in the main interface,
and uses calibrator to test more than three times to obtain mean.
2. Click Cal in the main interface ,enter calibration interface, and click Manual
Cal into the interface as figure 9-3 show:
Figure 9-3 Manual Calibration
NOTE
¾ WBC Impedance Count (WIC) is the result of WBC that obtain through
electrical impedance method. And WBC Optical Count (WOC) is the result
of WBC that obtains through optics method.
¾ The analyzer can calibrate a certain or all parameters of WIC，WOC，RBC，
HGB，MCV，MPV, RDW_CV, RDW_SD, PLT，PDW.
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¾ Click Save to save the data before exit system calibration or the data will
be loss.
3. Input the assay and values of desired parameters of calibrator, and click
Cal, the system will automatically calculate the new calibration
coefficient.(See figure 9-4)
Figure 9-4 Calculate Coefficient

4. Click Save to save the new setting.
Figure 9-5 save

(1) Test the calibrators three times at least, and check whether the results are
within the allowed range.
for three times at least and check whether the results are within the allowed
range.
105
Chapter 10 Maintenance and Care
10.1 Overview
Routine care and regular maintenance are essential to keep the best
status, precision of the analyzer and minimize system problems, prolong the
life span. Procedures and instruction for preventive maintenance are
discussed in this chapter. More information is available at NeoMedica
Customer Support Centre.
Preventive maintenance should be performed daily, weekly and monthly.
Pertinent maintenance is also included in this Chapter according to actual
requirement.
WARNING
¾ Considering all components’ surface may be potentially infectious, safety
protective measures should be taken to avoid infection, electric shock or
burn. Wear gloves when some cleaning do or maintenance works. Clean
hands with disinfectant after work.
10.2 Routine Maintenance
10.2.1 Daily Maintenance

1. Time Set
The analyzer is designed with auto-maintenance program. Instrument
should be set to automatically perform cleaning after continuously working on
more than 60 specimens. And background test should be set to perform
automatically after startup.
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Figure 10-1 Setup

2. Shutoff
To get correct results, it’s necessary to clean counting chambers and rinse
the flow system to prevent measurement errors caused by residues. Shutoff
program should be performed when the analyzer tests more than 500
specimens or finish today’s work. If continuously use the instrument, shutdown
program should be performed once at least every 24 hours. For detail
instructions, please refer to chapter 7 Daily Operation of Shutoff.
10.2.2 Weekly Maintenance

1. Surface Maintenance
Clear the smudge on the surface, especially the blood on the aspiration
probe and its surrounding, to remove the protein aggregation or debris to
reduce the possibility of the blockage. Wipe the outside of the probe and
surrounding with gauze soaked by litmusless detergent before cleaning other
parts.
CAUTION
¾ Never use corrosive acids, alkali or volatile organic solvent (such as
acetone, aether and chloroforms) to wipe the outside of the analyzer, but
only litmusless detergent.
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2. Clean Aspiration Probe
Figure 10-2 Clean Aspiration probe

In the main interface select Maint, enter the interface as figure 10-2, and
select Clean Aspiration Probe to clean aspiration probe. Regular cleaning of
the clean aspiration probe ensures the accuracy and precision of performance,
prevent block caused by reagent and blood residue. The clean aspiration
probe will be dirty after a long time use, so remove it and clean the clean
aspiration probe with distilled water are necessary. Aspiration probe must be
cleaned with detergent firstly and then with distilled water again. For detailed
NeoMedica Customer Support Centre.
10.2.3 Monthly Maintenance

1. Check and Clean Reagent Syringes
The Reagent Syringes need to be cleaned on a regular basis to prevent
reagent residue buildup, which may cause leakage or improper functioning.
Syringes should be cleaned one at a time to ensure that each syringe is placed
in the correct position. Replace each syringe after it is cleaned and then
remove the next one to be cleaned.
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Materials Required:
1. A large container filled with approximately 500 mL of deionized water;
2. Clean and soft cloth;
3. Deionized water;
4. Small container of appropriate reagent to refill the clean syringes;
5. Appropriate personal protective equipment.
Clean Procedure:
1. Empty the flow system;
2. Remove the front covers to gain access to the Syringe Assembly.
3. Lift the syringe out of the snap-in bracket.
4. Aspirate the deionized water into the syringe until it is full. Continue to pull
on the plunger until it is removed from the barrel.
5. Rinse the plunger and barrel thoroughly with deinoized water. If the seal
ring has been worn to be replaced with new.
6. Carefully reinsert the plunger into the wet barrel.
7. When the syringe has been reinstalled, run several background counts
and observe the action of each syringe during the cycle. The plunger
should move smoothly up and down and the syringe should not leak.
CAUTION
¾ Do not push or pull on the plunger when the syringe is dry, as it may
damage the plunger. Avoid touching the plunger because oil from the
fingers may cause it to move erratically.
2. Maintenance of mechanical parts
It mainly aims at mechanism maintenance, including lubricate electricity
axis, X, Y leader of sampling organ etc. In the red area picture below shows:
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Figure 10-3 Maintenance of mechanical parts
10.3 Maintenance procedure

In main interface, click Maint into the interface as figure 10-4:
110
Figure 10-4 Maintenance Interface

The analyzer offers the following three maintenance operations on flow
system:
Prime: Aspirate all or depart of reagents to the corresponding tube to
replace the reagent.
Clean: Clean count chamber, aspiration probe, etc.
Empty: Empty count chamber, waste chamber, vacuum accumulator or all
tube.
10.3.1 Fluidics Cleaning

In the following conditions, perform this operation:
Use the analyzer first time;
Replace all reagents;
The tubes are dirty, need to clean;
Make sure the analyzer has problem.
Operate as the following steps:
1. Select Prime Fluidics in the Maintain interface;
2. The analyzer starts to replace diluent, detergent and sheath, and display
the progress bar at the bottom of screen.
3. The operation is completed and back to the Maintain interface.(see figure
10-5)
111
WARNING
¾ Considering all the specimens, controls, calibrators and waste etc. that
NOTE
¾ Keep the reagent still for a certain time to ensure it stable.
¾ After replace the diluent, detergent or sheath, perform background count to
ensure the background values are in the acceptable range.
Figure 10-5 Prime Fluidics
10.3.2 Diluent Replacement

In the following three conditions, perform this operation:
There are bubbles in the diluent tubing;
The diluent in tubing is contaminated;
Replace a new diluent.
The procedures as follows:

1. Select Prime Diluent in MAINT interface;
112
2. The analyzer start to perform the function and display the process bar at
the bottom of screen;
3. The operation is completed and back to the MAINT interface.
10.3.3 Detergent Replacement

There are bubbles in the detergent tubing;
The detergent in tubing is contaminated;
Replace a new detergent.

1. Select Prime Detergent in MAINT interface;
10.3.4 Sheath Replacement

Three are bubbles in the WOC Flow Cell;
The sheath in tubing is contaminated;
Replace a new sheath.

1. Select Prime Sheath in MAINT interface;
10.3.5 Cauterize Aperture

Cauterize both sides of the ruby aperture with a high voltage to clear
protein, dust etc. that adhere or block on the aperture, to prevent and eliminate
blockage associating. The procedures as follows:
1. Select Cauterize Aperture in the MAINT interface;
the bottom of the screen;
3. The operation is completed and back to the MAINT interface.(see figure
10-6)
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Figure 10-6 Cauterize Aperture
10.3.6 Flush Aperture

Flush aperture may rinse the ruby aperture and prevent and eliminate
blockage associating with Cauterize Aperture. The procedures as the follows:
1. Select Flush Aperture in the MAINT interface;
10.3.7 Clean Transducers
WARNING
¾ Considering all the specimens, controls, calibrators and waste etc. that
114
Clean Transducers function is to rinse transducers with diluent and scour

it with play bubbles. The procedures as the follows:
1. Select Clean Transducers in the MAINT interface;
If blockage is severe, select Empty WBC Cup or Empty RBC Cup, the
analyzer will automatically empty the liquid in both sides of the aperture. And
remove the ruby aperture, brush it with probe detergent or enzyme, then wash
it with distilled water. If the ruby aperture has been reinstalled, run several
times of background counts to check whether it is blockage.
CAUTION
¾ Consider the probe detergent is corrosive; operator should wear lab coats,
gloves, and follow required laboratory or clinical procedures.
10.3.8 Prepare Shipping

Perform this function before shipping or leave unused for a long time, the
procedures as the follows:
(1) Take out the diluent inlet tube connecting with the diluent port on the rear
panel from container, discharge the diluent remained in tube;
(2) Take out the detergent inlet tube connecting with the detergent port on the
rear panel from the container, discharge the detergent remained in tube;
(3) Take out the sheath inlet tube connecting with the sheath port on the rear
panel from container, discharge the sheath remained in tube;
(4) Keep the remaining reagents in their containers and store them according
to instructions. Operator should establish and confirm to the effective
storage measures to prevent reagent from deteriorated, misusage or
misdrinking. The reagent should be away from temperature extremes.
(5) Select Prepare Shipping in the MAINT interface;
(6) The analyzer start to perform the function and display the process bar at
(7) The operation is completed and back to the MAINT interface. (see the
figure 10-7)
115
Figure 10-7 Prepare Shipping
10.3.9 Other Maintenances

Clean Aspiration Probe--------scour the inside of aspiration probe with diluent.
Clean sheath channel--------clean Pre-mixing chamber and WOC Flow Cell.
Clean Impedance Channels--------clean WBC/RBC counting chamber and
volumetric metering tube.
Open Press Control Module--------provide pressure for press chamber and
negative press for negative press chamber.
Close Press Control Module--------close the pressure on the press chamber
and negative press chamber.
Empty Waste Chamber--------discharge the waste remained in waste chamber
to the outside of analyzer.
Empty RBC Transducer--------empty the diluent remained in the RBC cup.
116
Chapter 11 Troubleshooting
117
Chapter11 Troubleshooting
11.1 Overview
This chapter gives instructions for identifying, troubleshooting and
correction of analyzer problems. If the malfunction is not solved according to
the guidance or more detail information is needed, please contact NeoMedica
Customer Support Centre.
NOTE
¾ This manual is not a maintenance manual, but provides the measurements
when the analyzer malfunction alarm only.
WARNING
¾ Considering the analyzer handling the materials that contain human blood
or serum as being potentially infectious, please follow the established
bio-safety procedure when maintain or troubleshoot the analyzer.
11.2 Troubleshooting Guidance

Troubleshooting Guidance is designed to assist operator in identifying and
resolving analyzer problems. Instruction is also given for obtaining technical
assistance immediately from NeoMedica Customer Support Centre. The first
step in the process is to understand normal analyzer operation and preventive
maintenance. Good experience of the analyzer is essential for identifying and
resolving operational problems. Logical troubleshooting may be divided into
three steps:
(1) Problem Identification
(2) Problem Isolation
(3) Corrective Action
Step1: Problem Identification means not only identifying what is wrong, but
also what is right. The investigation should identify the problem area and
eliminate areas that are right. Once done, the troubleshooting process moves
quickly to next step.
Step2: Problem Isolation means further classifying the problem. Analyzer

problems are generally divided into three categories:
(1) Hardware component related;
(2) Software computer programs related;
(3) Measurement related to sample analysis.
Hardware and software problems can only be corrected by a NeoMedica
118
authorized engineer. The operator can correct sample measurement problems

with assistance from NeoMedica engineers.
Step3: Corrective Action

Corrective Action means operator taking appropriate action to correct the
problem. If operator can correct the problem, with or without technical
assistance from the manufacture, normal operation can quickly resume.
11.3 Obtaining Technical Assistance

Technical assistance is obtained by calling the NeoMedica Customer
Support Centre. When assistance is needed, please be prepared to provide
the following information for Customer Support Specialists:
(1) The analyzer model;
(2) Serial number and version number;
(3) Description of the problem and surroundings, including status and
operation;
(4) The lot number of the reagents (sheath, diluent, detergent etc.)
(5) Related data and report of the problem.
Familiar problems and disposals are given in this Chapter. The operator
can identify the cause according to the warning information and operate
according to Troubleshooting Guidance.
11.4 Troubleshooting
Familiar problems and corrective actions are listed as follows. If the
problems cannot be corrected, or technical assistance is needed, please
contact with NeoMedica Customer Support Centre.
11.4.1 Faults Related to Reagents
Fault Probable Cause Corrective Action

z Check that if diulent is run out.
z Perform Maint→Prime Diluent.
Diluent empty Diluent is run out.
z If fault still occurs, please contact
with NeoMedica.
z Check that if the detergent is run out.
Detergent z Perform Maint→Prime Detergent.
Detergent is run out.
empty z If the fault still occurs, please contact
with NeoMedica.
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z Check that if the sheath is run out.

z Perform Maint→Prime Sheath.
Sheath empty Sheath is run out
z If the fault still occurs, please contact
with NeoMedica.
z Check that if the waste container is
full.
Waste container is
z Check that if the sensor is wet or
Waste full full or waste sensor
short circuit.
is in fault.
with NeoMedica.
11.4.2 Faults Related to Test Value

Fault Probable Cause Correction Action
z Check that if the reagents are
contaminated or overdue.
z Perform Maint→Prime Fluidics to
Reagents are rinse the flow system.
High
contaminated z If the fault still occurs, perform
background
oroverdue; Reagent aint→Clean Transducers. Run a
value
tube Contaminated. background test again to check if the fault
disappeared.
with NeoMedica.
z Check that if Detergent is run out.
WOC/HGB cup is z Perform Maint→“Empty WOC/HGB
HGB
dirty, Detergent is cup” and“Prime HGB cup”to clean the
inaccuracy
overdue. HGB cup, if the fault still occurs, please
contact with NeoMedica.
z Perform Cauterize Aperture or Flush
Aperture in the MAINT interface. Then run
a background counting to check the count
ruby aperture clogged; time.
RBC clog WBC counting time z If fault still occurs, inject probe
incorrect; detergent with the syringe into RBC cup
to soak the ruby aperture.
z If fault still occurs, please contact with
NeoMedica.
120
z Check that the diluent or detergent if

run out.
Diluent or etergent run z Check the reagent tubing connection,
out or deficient. prevent leakage.
RBC bubble
Reagent tubing loose z Perform Tubing Clean in MAINT
leads to leakage. interface.
with NeoMedica.
11.4.3 Fault Related to Hard Ware

Fault Probable Cause Correction Action
z The power wire is z Check the power wire connection.

not connection well z Check whether the fuse has burned
No response
with the power socket. out.
when startup
z The fuse may be z If the fault still occurs, turn off the
burnout. power, and contact with NeoMedica.
z Moto connecting
wire loose.
z Travel
Moto sounds Turn off the power, and contact with
Optocoupler problem.
abnormally NeoMedica.
z Moto problem;
z Moto drive circuit
problem.
z Check the power wire and connecting
wire of the printer. If the printer still
doesn’t work, please re-plug wires and
restart the computer and printer.
z Connecting wire
Printer no z If the fault still occurs, connect the
problem.
response printer to another normal computer
z Printer problem
separately and install the driver to test the
printer if it is normal.
with NeoMedica.
121
Appendix A Specifications
A.1 Technical Specifications
A.1.1 Parameters
Abbreviation Full Name Unit

WBC White Blood Cell Count 109cells/L
LYM% Lymphocyte Percent %
MON% Monocyte Percent %
NEU% Neutrophile Percent %
EOS% Eosinophile Percent %
BAS% Basophil Percent %
LYM# Lymphocyte Count 109cells/L
MON# Monocyte Count 109cells/L
NEU# Neutrophile Granulocyte Count 109cells/L
EOS# Eosinophile Granulocyte Count 109cells/L
BAS# Basophil Granulocyte Count 109cells/L
RBC Red Blood Cell Count 1012cells/L
HGB Hemoglobin g/L
HCT Hematocrit (relative volume of erythrocytes) %
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular Hemoglobin pg
MCHC Mean Corpuscular Hemoglobin Concentration g/L
RDW_CV Red Blood Cell Distribution Width repeat precision %
RDW_SD Red Blood Cell Distribution Width STDEV fL
PLT Platelet Count 109cells/L
MPV Mean Platelet Volume fL
PDW Platelet Distribution Width fL
PCT Plateletcrit %
P_LCC Large Platelet Count 109cells/L
P_LCR Large Platelet Percent %
RETIC Reticulocyte %
RETIC_ABS Reticulocyte absolute number 109/ul
IIRF Immature Reticulocyte Fraction %
A.1.2 Test Speed

Not less than 60 / hour
122
A.1.3 QC Mode
There are four QC modes, L-J QC, X-B QC, X-R QC and X QC.
A.1.4 Reagents of Product

The reagents used in analyzer: diluent, Detergent, detergent and sheath. The
detail information about them is in A.4 Reagent Specification.
A.1.5 Calibration Mode

The modes of calibration are Calibrator Calibration, Whole Blood Calibration,
and Manual Calibration.
A.1.6 Parameters Measurement and Calculation

(1) The laser light method for determining the quantity and Five-Part-Diff of
WBC.
(2) Electrical impedance method for determining the quantity of RBC and PLT.
(3) The colorimetric method for determining the content of HGB.
(4) MCV，HCT，RDW，MPV，PDW，MCH，MCHC，PCT are obtained directly
by calculating the stored data.
A.1.7 Input/output Devices

(1) Outer computer;
(2) Outer printer (optional);
CAUTION
¾ Computer, printer and other external devices must be passed CCC(C&E)
Compulsory Certification. It may cause the system work improper system
work and personal injury by using substandard external devices.
123
A.2 Physical Specifications
A.2.1 Power Requirement
Optimum work Voltage Work Voltage range Frequency

AC 220V AC 100V～240V 50/60 Hz
A.2.2 Environment Requirement

(1) Temperature: 15°C~35°C;
(2) Relative Humidity: ≤85％;
(3) Barometric Pressure: 60kPa~106kPa;
A.2.3 Storage Environment

(1) Temperature: -20°C~55°C;
(2) Relative Humidity: ≤95%;
(3) Barometric Pressure: 50kPa~106kPa;
A.2.4 Size and Weight

(1) Height: about 488.5mm;
(2) Length: about 598.5mm ;
(3) Width: about 585mm;
(4) Weight: about 65Kg;
A.2.5 Waste Disposal

According to the standard of local or nation dispose the waste.
A.2.6 Minimum Sample Volume

Whole blood sampling mode 20µL
Pre-dilution Sampling Mode 20 µL
A.2.7 Dilution Ratio

(1) WBC: about 1:108
(2) RBC/PLT about 1:12500
A.2.8 Counting Aperture

(1) WBC: 100µm;
(2) RBC/PLT: 68µm;
A.2.9 HGB measurement

(1) Measure HGB in WBC/HGB cup;
(2) The illuminant is led, and the wavelength is 540nm.
124
A.3 Performance Index
A.3.1 Precision
Acceptable Limits
Parameter Precision Range
（CV%）
WBC 4.0 x109 /L ~15.0x109 /L ≤1.5%
RBC 3.00 x1012 /L ~6.00x1012 /L ≤1.0%
HGB 100 g/L ~180 g/L ≤1.5%
PLT 100 x109 /L ~500x109 /L ≤4.0%
HCT 35%~50% ≤2.0%
MCV 70 fL ~120 fL ≤1.0%
A.3.2 Linearity
Parameter Linearity Range Acceptable Limits
0 x109 /L ~10.0x109 /L ≤±0.3 x109 /L
WBC
10.1 x109 /L ~99.9x109 /L ≤±5%
0.10 x1012 /L ~1.00x1012 /L ≤±0.05 x1012 /L
RBC
1.01 x1012 /L ~7.00x1012 /L ≤±5%
0 g/L ~70 g/L ≤±2 g/L
HGB
71 g/L ~300 g/L ≤±2%
0x109 /L ~100x109 /L ≤±10 x109 /L
PLT
101 x109 /L ~999x109 /L ≤±10%
A.3.3 Accuracy of WBC five part differential

The measurement values of NEU, LYM, MON, EOS and BAS are in the
acceptable range. (99% of the confidence interval)
A.3.4 Carryover
Parameter Measurement Result
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
PLT ≤0.5%
A.3.5 Background Counting
Parameter Measured Value Range

WBC ≤0.20x109 /L
RBC ≤0.02x1012 /L
HGB ≤1g /L
PLT ≤10.0x109 /L
125
A.3.6 Accuracy
Parameter Acceptable Range (%)
WBC ≤±2.0%
RBC ≤±1.5%
HGB ≤±1.5%
MCV ≤±0.5%
HCT ≤±1.0%
PLT ≤±4.0%
A.3.7 Display Range of Main Parameter

Parameter Display Range
WBC 0～200.0 x 109/L
RBC 0～18.00 x 1012/L
HGB 0～300g/L
HCT 0%～80%
PLT 0～2000 x 109/L
A.4 Reagent Specifications
Name Model Specification

Diluent NCC-51 20L
Detergent NCC-51 20L
Sheath NCC-51 10L/20L
Detergent NCC-51 500mL/1L
CAUTION
¾ Do not pour the remaining reagent in it when replace a new reagent, or it
will lead to cross contamination of the reagents.
A.5 Reagent Consumption
Operation Diluent Detergent Sheath Lyse

Startup 36mL 25mL 9mL 3mL
Counting 41mL 18mL 7mL 0.4mL
Prime (Clean) 36mL 24mL 9mL 3mL
shutdown 30mL 10mL 9mL 0mL
126
A.6 Parameters Alert Messages
Suspect Suspect
Interpretive
Parameter Data Alerts Paramete Population
Messages
r Flags Flags
If the result
below lower
limit, it displays Leukopenia
in blue and NWBC Leukocytosis
marked L; FWBC When RRBC?
WBC WBC
If the result NRBC alarm, switch to
above upper RRBC RRBC mode for
limit, it displays counting again.
in red and
marked H;
Neutropenia
Differential
Neutrophilia
NEU BAND
Lymphopenia
LYM DFLT IG
Same as WBC Lymphocytosis
MON (NLMEB) BLAST
Monocytosis
EOS VARLYM
Eosinophilia
BAS
Basophilia
MPV
LRI Thrombocytopenia
Suppresse
PLT URI Thrombocytosis
Same as WBC d (not
MPV LURI Microcytic PLT
displayed
PLTR Macrocytic PLT
or printed )
127
Appendix B External communication protocol
A. Communication Protocol
Information is transferred by the following methods.
<SB>information<EB><CR>
<SB> is Start Block Character needs 1byte corresponds to ASCII <VT>
hexadecimal 0x0B
<EB> is End Block Character needs 1byte corresponds to ASCII <FS>
Hexadecimal 0x1C
<CR> is Carriage Return needs 1byte corresponds to ASCII <CR>
hexadecimal 0x0D
Information is the data that we want to transfer. Please refer to the following for
details.
B. Information Grammar
1. Delimiter
| --- Fields Delimiter
^ ---Component Delimiter
& --- Subcomponent Delimiter
~ --- Repeat Delimiter
\ --- Escape Character
2. Data Type
CX extended composite id which check digit
CE code element
CM composite
CQ composite quantity with units
DR date time range
DT data
DLN driver’s license number
EI entity identifier
HD hierarchic designator
FN family name
FT formatter text
IS coded value for user-defined tables
ID coded values for HL7 tables
JCC job code
NM numeric
PT processing type
PL person location
ST string
SI sequence ID
128
TS time stamp
TQ timing quantity
TX text data
XAD extended address
XCN extended composite ID number and name
XON extended composite name and ID number for organizations
XPN extended person name
XTN extended telecommunications number
VID version identifier
3. Field Meaning
3.1. There is a message header at the beginning of each message. It is
MSH field.
The meaning of MSH is shown as below
No. Field Data Type Length Explanation
1 Field mark ST 1 Separator
2 Encoding chars ST 4 Separator listing
Sending
3 EI 180 Sending end applications
Application
4 Sending Facility EI 180 Sending end facility
Receiving Receiving end
5 EI 180
Application applications
6 Receiving Facility EI 180 Receiving end facility
Date Time Current message event,
7 TS 26
Message system time
8 Security ST 40 Security
9 Message Type CM 7 Message Type
Message control ID is
Message Control used to distinguish
10 ST 20
ID different messages. See
the table below.
11 Processing ID PT 3 Dispose of ID P Product
12 Version ID VID 60 HL7 version is 2.3.1
Application
13 Acknowledgment IS 1 Set null
Type
14 Retain
15 Retain
16 Retain
17 Retain
18 Encoder ST Encoding is UNICODE
MSH-10 Description
0001 Instrument transmits results automatically.
129
1001 LIS responses, instrument transmits results automatically.

Example:
MSH|^~\&|URI|UT-5200|LIS|PC|20100930100436||ORU^R01|0001|P|2.3.1|1|||
||UNICODE
3.2. PID--- Definition of patients' data field

Identify different
1 Set ID PID SI 4 fields, fill with 1
generally.
Patient ID., hospital
2 Patient ID EI 20
No., set null
Indicate batch number
3 Patient Identifier List CX 20
when QC
4 Alternate Patient ID CX 20 Bed No.
5 Patient Name XPN 48 Name
Mother’s Maiden Mother’s Maiden
6 XPN 48
Name Name, set null
Birthday；Indicate
7 Date/Time of Birth TS 26
validity when QC
8 Sex IS 1 Male or female
9 Patient Alias XPN 48 Retain patient alias
10 Race CE 80 Retain race
Retain patient
11 Patient Address XAD 106
address
12 County Code IS 4 Retain county code
13 Phone Number XTN 40 Retain phone No.
Retain office phone
13 Phone Number Bus XTN 40
No.
14 Primary Language CE 60 Retain mother tongue
15 Marital Status CE 80 Retain Marital Status
16 Religion CE 80 Retain religion
The rest part is not
…
needed to be filled.
Example: PID|1|1010051|A1123145|15|Mary||19811011|M
3.3. PV1---Definition of patient visiting record field

Identify different
1 Set ID PV1 SI 4 fields, fill with 1
generally.
2 Patient Class IS 1 Patient category
3 Assigned Patient PL 80 Be used to indicate
130
Location patient department

Example: PV1|1Clinic| Surgery |
3.4. OBR--- Definition of Doctor's Advice

Identify different
1 Set ID OBR SI 4 fields, fill with 1
generally.
2 Placer Order Number EI 22 Serial number
Assigned Patient
3 EI 22 Sample number
Location
4 Universal Service ID CE 200 Universal service ID
5 Priority ID 2 Priority set null
6 Requested Date Time TS 26 Application time
Observation Date Inspection starting
7 TS 26
Time time, set null
Observation Date
8 TS 26 Inspection end time
Time end
Specimen collection
9 Collection Volume CQ 20
capacity, set null
10 Collector Identifier XCN 60 Sender name
Sample handling
11 SPE Action Code ID 1
code, set null
12 Danger Code CE 60 Danger code alarm
"Diagnosis" ^
"Remark", each length
13 Relevant Clinical Info ST 200
should not be more
than 100 bytes
SPE Received Date
14 TS 26 Sample receiving time
Time
Sample classification,
15 SPE Source CM 300
blood, urine etc.
16 Ordering Provider XCN 120 Inspector name
Order Callback Callback phone, set
17 XTN 40
Phone Number null
Sender field 1,
18 Placer Field1 ST 60
Inspection department
19 Placer Field2 ST 60 Set null
Operator field 1, set
20 Filler Field1 ST 60
null
The rest part is not
… Set null
needed to be filled.
28 Result Copies to XCN 60 Verifier
131
Example：
OBR|1|1010051|000001|URIÛT-5200||20101010093000||20101010093500||
sender||| diagnosis^remark||BLD|Inspector||||||||||||verifier|
3.5. OBX
Identify different
1 Set ID OBX SI 4 fields, fill with 1
generally.
NM means figure
2 Value Type ID 3 type, ST means value
type
Observe identifier
3 Observation Identifier CE 590
name
Observe sub-id
4 Observation Sub ID ST 20
project name
5 Observation value ST 65535 Check result
6 Units CE 90 Unit
Reference range is
from small to big; QC
7 References Range ST 90
means reference
value and deviation.
H,L and N indicate
8 Abnormal Flags ID 5 high, low and normal
value respectively.
9 Probability ID 5 Probability, set null
C indicates WBC and
Nature of Abnormal RBC clog; B indicates
10 ID 2
Test bubble, when normal,
set null
Observe results, take
11 Observe Status ID 1
F for final result.
The time for observing
12 Date Last Observe TS 26
normal value, set null
User Defined Access
13 ST 20 Original results
Checks
Example: OBX|1|NM|WBC||8.21|10^9/L|4.00-10.00|L|||F||
3.6. MSA
Confirmation code: AA
Acknowledgment is for receiving, AE for
1 ID 2
Code error and AR for
refusing.
132
Message Control ID
2 ST 20
3 Text Message ST 80 Message
Expected Sequence
4 NM 15
Number
Delayed
5 Acknowledgment ID 1
Type
6 Error Condition CE 100 Error condition
MMSA-6 is used to indicate different errors, see the table below.

MSA-1 MSA-6 MSA-3 False Description
AA 0 Message accepted Receive successfully
The fields order in
Segment sequence message is not correct, or
101
error the necessary fields are
lost.
Necessary fields of a
102 Required field missing
AE paragraph are lost.
Data type of fields is false.
103 Data type error For example, digital is
changed into character.
104 Key not found Key identifier is not found
105 Resend Resend data
Unsupported message Unsupported message
201
type type
Unsupported event
202 Unsupported event code
code
Unsupported Unsupported processing
203
processing id ID
Unsupported version
204 Unsupported version ID
id
Unknown key identifier，
AR For example, transmit an
205 Unknown key identifier
inexistent patient
information.
206 Duplicate key identifier Duplicate key identifier
Affairs in application
Application record storage level can't be
207
locked carried out. For example,
database is locked
Application internal Other errors in unknown
208
error application.
133
209 Application unready Application is not ready

3.7. ERR
1 Error Code and CM 80 Code and position
Location error
ERR-1
Assembly 1 Assembly 2 Assembly 3 Explanation
Record
The test tube record has
001 already Test tube No.
already existed.
exist
Lis
Lis receiving error,
002 Recieved Test tube No.
resending data is required.
Faild
Read REQ
003 Test tube No. Fail to read request form.
error
Read
Instrument fails to read test
004 BarCode Test tube rack No.
tube number.
Errer
3.8. QRD
1 Query Date/Time TS 26 Query time
Query Format
2 ID 1 D （display format）
Code
3 Query Priority ID 1 I（Immediate）
Distinguish different
queries ,accumulate with
4 Query ID ST 10
query times. The initial
value is 1.
Deferred
5 ID 1 Set null
Response Type
Deferred
6 Response TS 26 Set null
Date/Time
Quantity Limited
7 CQ 10 RD（Records）
Request
Take as a test tube code
8 Who Subject Filter XCN 60
\ sample number.
9 What Subject Filter CE 60 OTH
What Department
10 CE 60 Set null
Data Code
What Data Code
11 CM 20 Set null
Value Qual.
134
Query Results
12 ID 1
Level
3.9. QRF
Where Subject
1 ST 20 Take UT-5200
Filter
When Data Start
2 TS 26 Application time
Date/Time
When Data End
3 TS 26 Deadline
Date/Time
What User
4 ST 60 Set null
Qualifier
Other QRY Subject
5 ST 60 Set null
Filter
RCT(Specimen
Which Date/Time receipt date/time,
6 ID 12
Qualifier receipt of specimen in
filling ancillary (Lab))
Which Date/Time
7 ID 12 ANY(Any status)
Status Qualifier
Date/Time ALL(All values within
8 ID 12
Selection Qualifier the range)
When
9 Quantity/Timing TQ 60 Set null
Qualifier
3.10. QSP
1 Set ID - DSP 4 SI
2 Display Level SI 4
3 Data Line TX 300 Content queried
4 Logical Break Point ST 4
5 Result ID TX 20
Use QSP-1 to distinguish different queried information in QSP fields.

Set ID – DSP Message
1 Test Tube Number
2 Serial Number
3 Name
4 Sex
5 Birthday
6 Blood Type
7 Group
135
8 Patient Number
9 Bed Number
10 Patient Type
11 Department
12 Sender
13 Inspector
14 Verifier
15 BLDV is for venous blood, BLDC is for peripheral blood.
16 Clinical diagnosis
17 Remark
18 Sampling time, sending time
19 inspection time
Example
DSP|1||Mary||<CR>
4. Communication process
4.1. Instrument transmits test results to lis server
NCC-51 Lis
ORU^R01 server
<SB>
MSH
PID
PV1
OBR
OBX
OBX
……
<EB><CR>
OBX fields can be repeated. Transmitted test results include patient

information, 24 parameters, 2 histograms and 2 scatter plots. The 2 histograms
and 2 scatter plots are BMP format and transmitted with base64 code;
For example：
Instrument transmits test results to lis server
<SB>
136
MSH|^~\&|URI|UT-5200|LIS|PC|20110627144458||ORU^R01|0001|P|2.3.1||||||
UNICODE<CR>
PID|1||||||||<CR>
PV1|1|||<CR>
OBR|1||BAR101010101|URIÛT-5200||||01110621143134|||||^||||||||||||||||<CR>
OBX|1|NM|WBC||110.0|10^9/L|40.0-100.0|H|||F|||||||<CR>
OBX|2|NM|LYM||35.57|%|20.00-40.00||||F|||||||<CR>
OBX|3|NM|MON||5.84|%|3.00-8.00||||F|||||||<CR>
OBX|4|NM|NEU||57.37|%|50.00-70.00||||F|||||||<CR>
OBX|5|NM|EOS||1.14|%|0.50-5.00||||F|||||||<CR>
OBX|6|NM|BASO||0.08|%|0.00-1.00||||F|||||||<CR>
OBX|7|NM|LYM#||284.5|10^9/L|80.0-400.0||||F|||||||<CR>
OBX|8|NM|MON#||46.7|10^9/L|10.0-80.0||||F|||||||<CR>
OBX|9|NM|NEU#||458.9|10^9/L|200.0-700.0||||F|||||||<CR>
OBX|10|NM|EOS#||9.1|10^9/L|0.0-50.0||||F|||||||<CR>
OBX|11|NM|BASO#||0.6|10^9/L|0.0-10.0||||F|||||||<CR>
OBX|12|NM|RBC||4.49|10^12/L|3.50-5.50||||F|||||||<CR>
OBX|13|NM|HGB||0|g/L|0-1079738368|L|||F|||||||<CR>
OBX|14|NM|HCT||26.4|%|37.0-50.0|L|||F|||||||<CR>
OBX|15|NM|MCV||59.0|fL|80.0-100.0|L|||F|||||||<CR>
OBX|16|NM|MCH||24.0|pg|27.0-31.0|L|||F|||||||<CR>
OBX|17|NM|MCHC||0|g/L|0-1081344000|H|||F|||||||<CR>
OBX|18|NM|RDW_CV||16.1|%|11.5-14.5|H|||F||||||<CR>
OBX|19|NM|RDW_SD||45.0|fL|35.0-56.0||||F||||||<CR>
OBX|20|NM|PLT||0|10^9/L|0-1079574528|H|||F|||||||<CR>
OBX|21|NM|MPV||12.3|fL|7.0-11.0|H|||F|||||||<CR>
OBX|22|NM|PDW||14.7|fL|15.0-17.0|L|||F|||||||<CR>
OBX|23|NM|PCT||0.41|%|0.10-0.28|H|||F|||||||<CR>
OBX|24|NM|P_LCR||1.37|%|0.50-1.80||||F|||||||<CR>
OBX|25NM|RBCHistogram^LeftLine||1||||||F||||||<CR>
OBX|26|NM|RBCHistogram^RightLine||118||||||F||||||<CR>
OBX|27|ED|RBCHistogram||UT5200^Histogram^512Byte^HEX^00000000000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||||||F||||||<CR>
OBX|28|NM|PLTHistogram^LeftLine||8||||||F||||||<CR>
OBX|29|NM|PLTHistogram^RightLine||127||||||F||||||<CR>
OBX|30|ED|PLTHistogram||UT5200^Histogram^256Byte^HEX^000000000505
137
0601010203040505060708090a0b0b0b0b0b0b0a0a0a0b0b0b0b0c0c0b0b0a
0a090807060605050505060606060605050504040303030302020202020202
02020202020202020202020202010101010101010202020202030303030202
0202010101010101020202020202020202020202020203030303030303||||||F
||||||<CR>
OBX|31|ED|S0_S10DIFFScattergram||UT5200Îmage^BMP^Base64^Qk32lg
MAAA……<CR>
OBX|32|ED|S90_S90DDIFFScattergram||UT5200Îmage^BMP^Base64^Qk32
lgMAAA……<CR>
<EB><CR>
138
Appendix C License for Manufacturing Measuring
Instruments
139
Appendix D Toxic and Hazardous Substances or
Elements
Toxic and Hazardous Substances or Elements
Polybromi-
Polybrominate-
Parts Plumbum Mercur Cadmiu Chromium nated
d Diphenyl
（Pb） y（Hg） m（Cd） VI（Cr(VI)） Biphanyls(
Ethers（PBDE）
PBB)
Shell ○ ○ ○ ○ ○ ○
Printed
circuit
× ○ ○ ○ ○ ○
board
Assembly
Sheet
metal ○ ○ ○ × ○ ○
Parts
Hos Plastic
t ○ ○ ○ ○ ○ ○
Parts
Machining
○ ○ ○ ○ ○ ○
parts
Hardware ○ ○ ○ ○ ○ ○
Flow
System ○ ○ ○ ○ ○ ○
Parts
Cable ○ ○ ○ ○ ○ ○
Accessories ○ ○ ○ ○ ○ ○
Packaging
○ ○ ○ ○ ○ ○
Materials
○：The content of toxic or hazardous substance in the homogeneous materials of the parts above is
in the acceptable range of SJ/T11363-2006.
×：The content of toxic or hazardous substance is exceed the acceptable range of SJ/T11363-2006
in at least one kind of homogeneous material of the parts above.
(The circuit board used lead solder in machining process and sonme parts of the board contain
plumb；And some sheetmetal parts use chromium VI for surface ）
Memo：Printed circuit board Assembly is consist of printed circuit board, capacitance, connector
and other parts. Lithium cell is detachable and recyclable part.
140
Appendix E Daily Operation Procedure
1. Startup and Run
(1) Make sure the power wire is properly connected; None reagent tubes is
bending or detached; Check if the waste container is full.
(2) Turn on the power of computer and analyzer;
(3) The analyzer starts to performing initialized self-checking program
automatically and rinse the flow system, then goes to main Interface. It’s
takes about 5 to 8 minutes.
(4) Perform a background count and QC control to ensure the analyzer
operates normally.
(5) Whole Blood Automated Sampling mode for analyzing a group of
specimens and Whole Blood Single Sampling mode for an emergency
specimen.
(6) Query, output and print the data.
(7) Necessary maintenance should be operated according to the situation.
2. Shutoff Procedures
(1) Click Exit in the main interface to shutoff;
(2) The analyzer automatically rinse the flow system;
(3) Turn off the power switches off the analyzer and computer when display
“Thank you for using, please turn off the power” display on the screen.
3. Daily Maintenance (perform it before shutoff)
(1) The analyzer will automatically perform daily maintenance with the time set
according to the quantity of the test samples.
(2) If ruby aperture is clogged, perform “Cauterize Aperture”, “Flush Aperture”
and “Clean Transducers” procedures in the MAINT interface.
(3) When continuously use the analyzer, shutoff procedure should be
performed at least once every 24 hours.
4. Weekly Maintenance
(1) The surface maintenance of the analyzer.
(2) Clean the aspiration probe.
5. Monthly Maintenance
(1) Check and clean the reagent syringes.
(2) Mechanical parts maintenance.
6. Other Maintenances
If the ruby aperture is block aging severely, select Empty WBC/RBC Cup,
the analyzer will automatically empty the liquid in both sides of the aperture.
And remove the ruby aperture, brush it with probe detergent or enzyme, then
wash it with distilled water. When the ruby aperture has been reinstalled, run
several times of background counts to check whether it is blockage.
141

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PHOENIX NCC-51

Five-Part-Diff Auto Hematology

1) Carefully read this manual before first operating the analyzer.

4.7.2 Tubing Installation............................................................................................ 27

7.8 Data Query and Output .............................................................................................. 65

10.2.1 Daily Maintenance ........................................................................................ 106

A.3.5 Background Counting .................................................................................. 125

Wellkang Ltd t/a Wellkang Tech Consulting

1.2 How to Use This Manual

1.3 Hazard Sign

Denotes the operator should follow the instruction under

Denotes potential hazards that could result in a minor

Denotes potential bio-hazard.

Maintenance Chapter 10 Maintenance and Care

Item Content Explanation

Prec is ion stepper

2.2 Special Requirements

2.3 General Requirements

2.4 Electromagnetism Security

 Wrong reagent or incorrect operation may cause wrong results.

2.6 Prevent Infected

Pollutants may also make the equipment unable to work.

2.11 Security Sign

Beware of electric shock

Protect from heat and radioactive

In vitro diagnostic medical device

exclusively. If being operated incorrectly by non-skilled staff,

2.13 Computer Virus

HCT Hematocrit (relative volume of erythrocytes) %

¾ The instrument needs several people work together to move since it is

Figure 3-1A Front View

Figure 3-1B Front View (Remove the front cover)

1--- Automatic Sampler

1--- Automatic Sampler

1--- Circuit board

Figure 3-4 Rear View

Figure 3-5 Vertical View（Optical Bench）

3.4 Counting Operation Screen

Figure 3-6 Counting interface

This interface can be divided into the following areas by functions:

Log Check the instrument operation and fault information

2. Data Edit Area

3. Shortcut Key Area

3.5 Reagent, Control and Calibrator

undercooling and overheating during storage.

(connected to the instrument), the product shelf life is only 60 days.

3.5.4 Probe Detergent

(1) Dissolve RBC instantly with minimum ground substance complex.

¾ Detergent and probe detergent is alkali cleaning agent

3.5.6 Control and Calibrator

¾ Environment Requirements: Temperature: 15 °C ~ 35 °C; Relative

¾ Installation of the analyzer by an unauthorized or untrained person could

This instrument has been tested strictly before delivery. It should be

4.2 Unpacking and Inspection

4.3 Space Requirements

4.4 Power Supply Requirements

4.5 Environment Requirements

4.6 Waste Requirements

4.7 System Installation

4.7.1 Computer Installation

Wrong reagent or incorrect operation may cause wrong results.