Copyright and Declaration

Welcome to use our automated hematology analyzer. It will bring you

new experience and convenience.
Declaration
All contents in this manual were strictly compiled according to related
laws and regulations in China, as well as the specific condition of automated
hematology analyzer, covering all the updated information before printing.
Supplier 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 supplier.
All instructions must be followed strictly in operation. In no event should
supplier 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 automated hematology analyzer, defines the rights and
obligations between the supplier and the customers about the responsibility
for quality warranty and after-sale service, also the related agreements on
commencement and termination.
Supplier warrants the sold by the supplier 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.

Must meet the following requirements

1. According to this manual to operate the instrument.

2. The software and hardware which installed on the analyzer must comply
with the provisions of this manual.

3. Only the engineers who authorized by supplier can do the Maintenance and
repair, and only the spare parts which approve by supplier can be used.

4. Laboratory power supply in line with national or international laws and

regulations.

5. The samples are collected and storage under normal clinical laboratory

1
Copyright and Declaration

conditions.

6. The reagents comply with the provisions of the user manual.

7. Use the right tools to do the analyzer Maintenance or troubleshooting.

supplier 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 supplier.

c) Failure due to operation not under the instructions described in the

manual.

d) Replace accessories not specified by supplier, or after Maintenance or

repair by a service agent not approved or authorized by supplier.

e) Components are been dismounted, stretched or readjusted.

f) Operators not been trained.

Auto Hematology Analyzer hereinafter referred to as "analyzer".

CAUTION

THE ANALYZER IS FOR PROFESSIONAL AND PRESCRIPTION USE

ONLY.

Technical service and troubleshooting are provided by supplier Customer

Support Center. Professional technician and sale representative will be sent
to offer you timely service when necessary.

URIT Medical Electronic Co., Ltd.

Address:No. D-07 Information Industry District, High-Tech Zone, Guilin,
Guangxi 541004, P. R. China
Tel: +86（773）2288586
Fax: +86（773）2288560
Web: www.urit.com
Email: service@uritest.com

2
Copyright and Declaration

Shanghai International Holding Corp. GmbH (Europe)

Eiffestrasse 80, 20537 Hamburg, Germany

Version : 10/2015-C7

3
 Content
Copyright and Declaration.................................................................................I
Chapter 1 Introduction......................................................................................1
1.1 Overview.............................................................................................. 1
1.2 Scope of Application.............................................................................1
1.3 Intended Use........................................................................................1
1.4 Hazard Sign..........................................................................................1
1.5 Guidance..............................................................................................1
1.6 Technical Parameters..........................................................................1
1.7 Software...............................................................................................1
Chapter 2 Safety Information for Operation......................................................1
2.1 Overview.............................................................................................. 1
2.2 Special Requirements..........................................................................1
2.3 General Requirements.........................................................................1
2.4 Electromagnetism Security...................................................................1
2.5 Installation............................................................................................1
2.6 Infection Prevention..............................................................................1
2.7 Reagent................................................................................................1
2.8 Maintenance.........................................................................................1
2.9 Laser.................................................................................................... 1
2.10 Consumables.....................................................................................1
2.11 Security Sign......................................................................................1
2.12 Operators...........................................................................................1
Chapter 3 System and Function.......................................................................1
3.1 Overview.............................................................................................. 1
3.2 Parameter.............................................................................................1
3.3 Structure...............................................................................................1
3.4 Boot interface.......................................................................................1
3.5 Test Interface....................................................................................... 1
3.6 Reagents, Control Materials and Calibrators........................................1
3.6.1 Diluent.........................................................................................1
i
Content

3.6.2 Sheath.........................................................................................1
3.6.3 Lyse............................................................................................ 1
3.6.4 Detergent....................................................................................1
3.6.5 Probe Cleaner.............................................................................1
3.6.6 Control Material and Calibrator...................................................1
Chapter 4 Installation........................................................................................1
4.1 Overview.............................................................................................. 1
4.2 Unpacking and Inspection....................................................................1
4.3 Space Requirements............................................................................1
4.4 Power Supply Requirements................................................................1
4.5 Environment Requirements..................................................................1
4.6 Waste Requirements............................................................................1
4.7 System Installation...............................................................................1
4.7.1 Tubing Installation.......................................................................1
4.7.2 Printer Installation.......................................................................1
4.8 Transport and Storage Requirement....................................................1
Chapter 5 Principles of Operation.....................................................................1
5.1 Overview.............................................................................................. 1
5.2 Sample Aspiration................................................................................1
5.3 Sample Dilution....................................................................................1
5.3.1 Whole Blood Sampling & 5Diff....................................................1
5.3.2 Pre-diluent CBC & 5Diff..............................................................1
5.4 WBC Test Principle..............................................................................1
5.4.1 Multi-Angle Laser Light Scattering Technology...........................1
5.4.2 WBC Differential.........................................................................1
5.5 Test Principle of Hemoglobin Concentration........................................1
5.5.1 Colorimetry Principle...................................................................1
5.5.2 HGB Parameter..........................................................................1
5.6 RBC /PLT Test Principle......................................................................1
5.6.1 Electrical Impedance Principle....................................................1
5.6.2 Volume Measuring......................................................................1
5.6.3 RBC Parameters.........................................................................1

ii
Content

5.6.4 PLT Parameters..........................................................................1

5.7 Principles of Reticulocyte Analysis.......................................................1
5.7.1 RBC Development Process........................................................1
5.7.2 Characteristics of Reticulocyte....................................................1
5.7.3 Testing Principle of Reticulocyte.................................................1
5.7.4 RETIC_ABS................................................................................1
5.7.5 IRF..............................................................................................1
Chapter 6 Settings............................................................................................1
6.1 Overview.............................................................................................. 1
6.2 Settings................................................................................................ 1
6.3 System Maintenance............................................................................1
6.4 X-B QC.................................................................................................1
6.5 X-R QC.................................................................................................1
6.6 X QC.................................................................................................... 1
6.7 Limit......................................................................................................1
6.8 Time..................................................................................................... 1
6.9 Parameter.............................................................................................1
6.10 Print....................................................................................................1
6.11 Transmit............................................................................................. 1
6.12 Maintenance Setting...........................................................................1
6.13 Version...............................................................................................1
6.14 User....................................................................................................1
6.15 Service............................................................................................... 1
6.16 Reagent..............................................................................................1
6.17 System Log........................................................................................ 1
6.18 Display............................................................................................... 1
Chapter 7 Daily Operation................................................................................1
7.1 Overview.............................................................................................. 1
7.2 Preparations.........................................................................................1
7.3 Startup..................................................................................................1
7.4 Quality Control......................................................................................1
7.5 Collection of Blood Samples................................................................1

iii
Content

7.5.1 Whole blood collection................................................................1

7.5.2 Diluent Sample Preparation........................................................1
7.5.3 Stability of Samples.....................................................................1
7.6 Create Next Blood Sample...................................................................1
7.7 Sample Test.........................................................................................1
7.7.1 Mode...........................................................................................1
7.7.2 Process of Counting and Analysis..............................................1
7.8 Data Query...........................................................................................1
7.8.1 Data Query..................................................................................1
7.8.2 Data selection.............................................................................1
7.8.3 Data Deletion..............................................................................1
7.9 Reticulocyte analysis............................................................................1
7.9.1 Preparation for reticulocyte sample.............................................1
7.9.2 Reticulocyte test..........................................................................1
7.10 Edit Information..................................................................................1
7.11 Export.................................................................................................1
7.12 CV Value and Trend Graph................................................................1
7.13 Shutoff and Logout.............................................................................1
Chapter 8 Quality Control.................................................................................1
8.1 Overview.............................................................................................. 1
8.2 Quality Control Options........................................................................1
8.3 8.3 L-J QC............................................................................................1
8.3.1 Setup...........................................................................................1
8.3.2 QC Graph....................................................................................1
8.3.3 QC List........................................................................................1
8.4 X-B QC.................................................................................................1
8.4.1 X-B QC Edit................................................................................ 1
8.4.2 X-B QC Run................................................................................1
8.4.3 X-B QC Review...........................................................................1
8.5 X-R QC.................................................................................................1
8.5.1 X-R QC Edit................................................................................1
8.5.2 X-R QC Graph............................................................................1

iv
Content

8.5.3 X-R QC List.................................................................................1

8.6 X QC.................................................................................................... 1
8.6.1 X QC Edit....................................................................................1
8.6.2 X QC Edit....................................................................................1
8.6.3 X QC Graph................................................................................1
8.6.4 X QC Graph List..........................................................................1
Chapter 9 Calibration........................................................................................1
9.1 Overview.............................................................................................. 1
9.2 Calculation Frequency..........................................................................1
9.3 Preparation...........................................................................................1
9.4 Calibration Modes................................................................................1
9.4.1 Manual Calibration......................................................................1
9.4.2 Standard Calibration...................................................................1
9.4.3 Blood Calibration.........................................................................1
Chapter 10 Service...........................................................................................1
10.1 Overview............................................................................................ 1
10.2 Routine Maintenance.........................................................................1
10.2.1 Daily Maintenance.....................................................................1
10.2.2 Weekly Maintenance.................................................................1
10.2.3 Monthly Maintenance................................................................1
10.3 Maintenance procedure......................................................................1
10.3.1 Change Lyse.............................................................................1
10.3.2 Change Diluent.........................................................................1
10.3.3 Change Detergent.....................................................................1
10.3.4 Change Sheath.........................................................................1
10.3.5 Cauterize Aperture....................................................................1
10.3.6 Flush Aperture..........................................................................1
10.3.7 Soak Impedance Transducer....................................................1
10.3.8 Prepare Shipping......................................................................1
10.3.9 Others.......................................................................................1
10.4 Components Maintenance.................................................................1
10.5 Components Replacement.................................................................1

v
Content

Chapter 11 Troubleshooting.............................................................................1
11.1 Overview............................................................................................ 1
11.2 Troubleshooting Guidance.................................................................1
11.3 Obtaining Technical Assistance.........................................................1
11.4 Troubleshooting..................................................................................1
Appendix A Specification..................................................................................1
A.1 Product classification...........................................................................1
A.2 Reagents..............................................................................................1
A.3 Model of Blood Sampler.......................................................................1
A.4 Technical Specifications......................................................................1
A.4.1 Parameters.................................................................................1
A.4.2 Test Speed.................................................................................1
A.4.3 QC Modes.................................................................................. 1
A.4.4 Calibration Modes.......................................................................1
A.4.5 Parameters Measurement and Calculation................................1
A.4.6 Input/output Devices...................................................................1
A.5 Physical Specifications........................................................................1
A.5.1 Power Requirements..................................................................1
A.5.2 Fuse............................................................................................1
A.5.3 Electromagnetic compatibility.....................................................1
A.5.4 Sound pressure..........................................................................1
A.5.5 Environment Requirements........................................................1
A.5.6 Storage Environment..................................................................1
A.5.7 Size and Weight.........................................................................1
A.5.8 Contraindications........................................................................1
A.5.9 Overvoltage Category and Pollution Level.................................1
A.5.10 Waste....................................................................................... 1
A.5.11 Minimum Sample Volume.........................................................1
A.5.12 Dilution Ratio............................................................................1
A.5.13 Diameter...................................................................................1
A.5.14 HGB measurement...................................................................1
A.6 Performance Index...............................................................................1

vi
Content

A.6.1 Precision.....................................................................................1
A.6.2 Linearity......................................................................................1
A.6.3 Accuracy of WBC Classification.................................................1
A.6.4 Carryover....................................................................................1
A.6.5 Blank Count................................................................................1
A.6.6 Indication error............................................................................1
A.6.7 Accuracy.....................................................................................1
A.6.8 Display Range of Main Parameters............................................1
A.7 Reagent Specifications........................................................................1
A.8 Parameters Alert Messages.................................................................1
Appendix B External communication protocol..................................................1
B.1 Communication Protocol......................................................................1
B.2 Information Grammar...........................................................................1
B.2.1 Delimiter..................................................................................... 1
B.2.2 Data Type...................................................................................1
B.2.3 Field Meaning.............................................................................1
B.3 Communication process......................................................................1
B.3.1 Analyzer transmits test results to lis server................................1
Appendix C Toxic and Hazardous Substances or Elements............................1
Appendix D Daily Operation Procedure............................................................1
D.1 Startup and Run...................................................................................1
D.2 Shutoff Procedures..............................................................................1
D.3 Daily Maintenance (perform it before shutoff)......................................1
D.4 Weekly Maintenance...........................................................................1
D.5 Monthly Maintenance...........................................................................1
D.6 Other Maintenances............................................................................1
Appendix E Key Components...........................................................................1
Appendix F Attachment list...............................................................................1

vii
 Chapter 1 Introduction

1.1 Overview

Welcome to read the Operation Manual of URIT-5160 5-Part-Diff Auto

Hematology Analyzer. This manual includes instructions of analyzer operation
and maintenance, as well as matters needing attention. To keep good
performance, you must operate and maintain this instrument according to the
manual.
URIT-5160 5-Part-Diff Auto Hematology Analyzer is an in vitro diagnostic
medical device. It can analyze and output 34 parameters, 2 scatter diagrams
and 2 histograms. It uses Multi-angle laser light scattering flow cytometry to
detect, use colorimetry to measure HGB, uses coulter theory to measure
WBC, RBC and PLT count.

NOTE

 Read this manual carefully before operating, especially the safety

information. Please keep this manual properly for future reference.

 Misoperation will lead to misdiagnosing and delay of illness caused by

inaccurate test results, or damage to operators and instrument, if it isn’t
used according to this manual.

 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 accuracy of instrument.

 Please follow the manual strictly when operating this instrument. Any
operations to simplify or optimize the inspection program may affect the
accuracy of the test results.

 There are no reticulocyte parameters in specific instruments.Therefore

there are only 31 parameters in these instruments.

1
Chapter 1 Introduction

1.2 Scope of Application

This manual applies to medical examiners, trained doctors, nurses and labors.
Untrained personnel may not operate the analyzer. Read this manual to learn
about URIT-5160's hardware and software, to set the system parameters and
to perform daily operations, system maintenance and troubleshooting.

1.3 Intended Use

URIT-5160 5-Part-Diff Auto Hematology Analyzer applies to quantitative

analysis of blood cells in clinical examination.

1.4 Hazard Sign

This manual uses the following warning conventions.

Symbol Meaning
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.

Prompts to operate according to symbols, emphasize

NOTE the important information in operation procedures and
the contents needed to pay attention to.

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.

2
Chapter 1 Introduction

The environment-friendly use period is 20 years, within

which can be rested assured to use. It should be carried
to a recovery system if more than environmental
protection use period.

Declaration
 The analyzer complies with the requirements of Emission and Immunity of
IEC/EN 61326-2-6.
 According to the GB4824 class B equipment calculation and testing, the
analyzer may cause radio interference in family environment. Please take
protective measures.
 Please make electromagnetic environmental assessment before using it.
 Intense radiation may interfere instrument operation. Please keep away
from it.

NOTE
 Please read this manual before the instrument is used, maintained and
moved.
 Please strictly follow this manual to operate.
 Operating this analyzer in dry environment, especially with man-made
materials (artificial fabrics, carpets, etc.), may cause static electricity and
wrong conclusion.
 Do not use this instrument near strong radiation sources, otherwise it may
be interfered.

3
 Chapter 1 Introduction

1.5 Guidance

Operator can find the needed information according to the following table.
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 Service
Troubleshooting Chapter 11 Troubleshooting
Detailed Specification Appendix A
Communications Protocol Appendix B
Name and content of poisonous and
Appendix C
harmful substances or elements
Daily operation procedures Appendix D
Key components Appendix E
List of Accessories Appendix F

4
 Chapter 1 Introduction

1.6 Technical Parameters

Item Content Explanation

34 parameters，2
Measured
scatter diagrams and Scatter diagram, histogram
Parameter
2 histograms
Open type sampling
Operation Only need 20µL blood sample for test
mode
Upgrade software by U disk or
Language English
online
Equipped with 10.4
Display Data management and networking
inch color LCD
Setting are convenient.
monitors.

Data Storage ≥ 200,000 test results (with graphics)

Speed 60 samples/ h
External printer.
Histogram can be
chosen to be
Reference range can be printed
printed. Different
Output Mode out in English and Chinese
warning signs
report format.
prompt probable
abnormalities of
specimen.
Whole Blood
Sampling Mode≤
Sample Use EDTA-K2/EDTA-K3 in
20µL
volume whole blood for anticoagulation
Diluent Sampling
Mode ≤20 µL

Reagents Diluent, Lyse, Detergent and Sheath

Sample Use the automatic Avoid samples cross

Probe Rinsing washing device to contamination and operators
flush the inside contact the samples.

5
 Chapter 1 Introduction

and outside wall of

sample aspiration
probe.
Precision stepper
Blood High precision and hard-
motor aspirates
Separation wearing.
samples.
Two units for WBC, Meet the parameters unit needs
Unit Selection RBC, HGB, PLT and for different countries and
other items. places.
Environmental regents can
Measure HGB by
avoid affecting operators'
cyanide-free
health, and be good for
spectrocolorimetry
HGB environmental protection. If use
colorimetry. LED
Measurement the toxic reagents, you need to
light source,
purchase specialist processing
540nm wavelength
equipment, which will increase
colorimetry.
costs.
Test RETIC percentage by multi-laser scattering
RETIC Test
method.
QC and Calibration modes include standard, blood and manual
Calibration calibration. QC modes includes L-J, X, X-R and X-B QC.
Adopt separately
Enhance accuracy and Maintain
Structure removable syringe
easily
structure.
Automatic monitoring
function prompts
operators to perform Improve the lifetime of
Maintenance automatic equipment, and Maintain the
maintenance or best working conditions
troubleshooting
procedures.
Reference With 9 different Parameters can be adjusted
Range groups normal range according to different geographical
parameter setting groups, and the analyzer will

6
 Chapter 1 Introduction

automatically identify and match the

function.
best reference.
High-voltage cautery, soaking with probe detergent, flushing
Flush
and intelligent auto rinsing.
It has a good electrical security with the flow electricity
Security
isolation system.
Host Size L490mm×W332mm×H459mm
Power 150VA-250VA
Fuse T3.15AL 250V
weight About 35kg

1.7 Software

Version:V5

7
 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

 5-Part-Diff Auto Hematology Analyzer is for blood cell count, WBC five
part differential and hemoglobin concentration measurement in clinical
laboratory.

 Only the reagents and detergents mentioned in this manual is allowed to

use. 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 analyzer must be operated in accordance with the methods

mentioned in this manual strictly.

 Keep long hair, fingers and clothes away from rotating parts.

 Turn off the power switch and unplug the power cord immediately if the
analyzer gives off odor or smoke, otherwise it will cause fire, electric
shock or injury. If this happens, please contact our after-sale service
department.

8
Chapter 2 Safety Information for Operation

 Do not spill the samples or reagent and do not let other things 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 may cause electric
shock.

 The analyzer must be connected to a power outlet 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 analyzer 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 inside the instrument may generate alternative electric field
and magnetic field.

 The analyzer may not function properly due to the strong electromagnetic
interference.

 It may cause data conversion errors and incorrect results due to strong
electromagnetic interference or 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 is corrupted if being
placed in a high pH environment.

 Avoid splashing water on the analyzer.

9
Chapter 2 Safety Information for Operation

 Do not expose the analyzer to the place with large temperature difference
and direct sunlight.

 Avoid vibration. The analyzer 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 analyzer does not produce ionizing radiation, but other equipment
which produces X-ray and γ-ray 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 analyzer should be
equipped with precision power supply or UPS.

 The equipment is about 35kg, so falling may cause injury during carrying.

 Wrong reagent or incorrect operation may cause wrong results.

2.6 Infection Prevention

 All the components and surface of the analyzer have 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 touch the waste and its components with free hands.

 If accidentally touch infectious material or surface, cleaning the skin with

water immediately, and then sterilize according to the laboratory
disinfection procedures.

 Analyzer 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.

10
Chapter 2 Safety Information for Operation

Even the control material 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 contact with reagents, since the reagents may irritate eyes,
skin and mucous membranes.

 If skin comes into contact with reagent, rinse it with plenty of water
immediately.

 If eyes come into contact with reagent, rinse it with plenty of water and
seek medical advice immediately.

 It’s necessary to establish a set of emergency measures in laboratory.

 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 spill. 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 it’s spilled 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 cleaner and detergent are strongly alkaline cleaner. Do not let
it come into contact with the skin or clothes. If that happens, rinse the skin
and clothes with plenty of water immediately.

 Probe cleaner contains sodium hypochlorite. If it comes into contact with

the analyzer surface, wipe up with a cloth immediately, otherwise it will
corrode the surface.

11
Chapter 2 Safety Information for Operation

 Ensure that the reagents keep the same level with the analyzer 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 operation manual.

 Do the daily, weekly, monthly Maintenance in accordance with the

operation manual .

 If the analyzer is not used for a long time, empty and rinse fluid system
according to the procedure before disuse. Ensure the analyzer is in a
good working condition before reuse.

 Reinstallation can only be done when replacing standby parts.

2.9 Laser

 The analyzer uses semiconductor laser. It’s a kind of class 3B laser

product, at wavelength of 531-533nm, and the maximum power 11mW. Its
visible 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 supplier can open it.

12
Chapter 2 Safety Information for Operation

2.10 Consumables

The disposal of residual reagents, detergent 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 instrument work
improperly.

2.11 Security Sign

Caution. Refer to the

Caution. Electric
accompanying
shock
document

Caution. Hot surface Biohazard

Protective earthing Power on

In vitro diagnostic
Power off
medical device

Keep away from heat

Environmental
and radioactive
protection lifetime
source

Serial number Manufacturer

May cause personal

Recovery
injury

13
Chapter 2 Safety Information for Operation

Refer to the operating

Put it up
manual

To be protected from
Do not roll
rain

Handle with Care Stacking layers limit

2.12 Operators

 This medical analyzer must be operated by well-trained personnel

exclusively. Misoperation will lead to misdiagnosing and delay of illness
caused by inaccurate test results, or damage to operators and instrument,
if it is used by untrained personnel. To avoid these risks, it’s necessary to
emphasize and make operators understand them.
 Operating not in accordance with instruction may lead to incorrect
operation and wrong parameter. It may damage the analyzer and result in
wrong diagnosis results.
 Maintenance should be carried out by professional technicians.
Unauthorized technicians or nonstandard maintenance will cause test
errors.
 Invalid hardware/software affects the accuracy of test results. Operator
needs to contact the after-sale service personnel as soon as possible.

WARNING
 Sample probe is sharp. It keeps moving when instrument is running, so
please don’t approach to it if you don’t operate instrument. Please operate
instrument in right way, and avoid pricking hands.

14
 Chapter 3 System and Function

3.1 Overview

5-Part-Diff Auto Hematology Analyzer is an in vitro diagnostic medical device. It

is used for blood cell count, WBC five part differential and hemoglobin
concentration measurement in clinical tests. This analyzer provides necessary
reference for clinical diagnosis.
The analyzer provides a fast count. All operations (including sampling,
measurement and results output) are full automatic. The analyzer automatically
starts testing after aspirating samples. Graphics data and results can be
displayed in the LCD screen about 60 seconds later. The results can be printed
or transmitted to the LIS system.
The biggest feature of the analyzer is that only 20µL blood sample is needed for
the test.

3.2 Parameter

The analyzer automatically analyzes and arranges the samples data and shows
the blood cell and white blood cell 5 part differential count respectively. Also, it
gives the scatter diagram of WBC and histogram of RBC and PLT, and
generates the following 34 test parameters in Table 3-1, two histograms and
two scatter diagrams.
Table 3-1 Parameters
Abbreviation Full Name Unit
WBC White Blood Cell Count 10^9/L
LYM% Lymphocyte Percent %
MON% Monocyte Percent %
NEU% Neutrophil Percent %
EOS% Eosinophil Percent %
BASO% Basophil Percent %
LYM# Lymphocyte Count 10^9/L

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Chapter 3 System and Function

MON# Monocyte Count 10^9/L

NEU# Neutrophil Granulocyte Count 10^9/L
EOS# Eosinophil Granulocyte Count 10^9/L
BASO# Basophil Granulocyte Count 10^9/L
RBC Red Blood Cell Count 10^12/L
HGB Hemoglobin g/L
RETIC-ABS Reticulocyte absolute value 10^12/L
RETIC Reticulocyte %
IRF Immature Reticulocyte Fraction %
Hematocrit (relative volume of
HCT %
erythrocytes)
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular Hemoglobin pg
Mean Corpuscular Hemoglobin
MCHC g/L
Concentration
Red Blood Cell Distribution Width repeat
RDW_CV %
precision
RDW_SD Red Blood Cell Distribution Width STDEV fL
PLT Platelet Count 10^9/L
MPV Mean Platelet Volume fL
PDW Platelet Distribution Width fL
PCT Plateletcrit %
P_LCR Large Platelet Percent %
P_LCC Large Platelet Count 10∧9/L
ALY% Abnormal Lymphocyte Percent %
ALY# Abnormal Lymphocyte Count 10∧9/L
LIC% Large Immature Cell Percent %
LIC# Large Immature Cell Count 10∧9/L
NRBC% Nucleated Red Blood Cell Percent %
NRBC# Nucleated Red Blood Cell Count 10∧9/L

Remark: PCT and PDW are the inferred parameters, for research only, but not

16
Chapter 3 System and Function

diagnosis. ALY%, ALY#, LIC% LIC#, NRBC% and NRBC# are research
parameters, for reference only.

3.3 Structure

WARNING

 The analyzer needs several people work together to move since it is large.
Please use proper tools and follow relevant safety code when moving.

 Take out the analyzer and then check whether the appearance is intact.
Ensure there is no damage during transport.

The analyzer is consisted of analysis part, information management part,

result output part and an external printer (optional).
The analysis part is mainly composed of laser parts, sampling unit, A/D and the
central control panel, the WBC measurement unit, RBC/PLT measurement unit,
fluid system, and display screen.

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Chapter 3 System and Function

Figure 3-1A Front View

1--- Screen
2--- Working Status Indicator
3--- Counting Button

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Chapter 3 System and Function

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

1--- Sampling Unit

2--- Syringe Mechanism
3--- Solenoid Valve

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Chapter 3 System and Function

Figure 3-2 Right Side View (Remove the right side door)

1--- Syringes Module 2--- Optical Module

3--- Sampling Unit 4--- Transducer

20
 Chapter 3 System and Function

33 2 1

Figure 3-3 Left Side View (Remove the Left side door)

1--- Liquid pot 2--- Pump

3--- Power Socket 4--- Power Switch
5--- USB and Internet Interface

21
Chapter 3 System and Function

Figure 3-4 Rear View

1---Cooling Fan 2---Liquid interfaces

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Chapter 3 System and Function

Figure 3-5 Vertical View（Optical Bench）

WARNING

 Semiconductor Laser is above the instrument. Do not open the upper cover
for your safety, only the personnel authorized by supplier can open it.

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Chapter 3 System and Function

3.4 Boot interface

Turn on the power switch on the left side, the analyzer program starts and enter
self-checking interface. See Figure 3-6.

Figure 3-6 Initialization

Login interface pops up after initializing. The default username and password
are “admin”. Click “Login” to enter test interface, click “Shut down” to turn it off.
See Figure 3-7.

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Chapter 3 System and Function

Figure 3-7 Login Interface

3.5 Test Interface

After startup, the analyzer enters test interface. See Figure 3-8.
5 1

Figure 3-8 Test Interface 3

5

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Chapter 3 System and Function

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

（1） Information prompt area

Display the anomalies that occur while using it.
（2）Analysis modes area
Select and indicate the system running state.
（3）System status area
Display the current time, date, operator, next ID and printer status.
（4）Parameter information area
Display each parameter results.
（5）Function buttons area

Display function buttons. There are three sets of function buttons.

The first set:

Figure 3-9A Function Button 1

Test: display test interface.

Data: enter data storage interface, query sample results.
QC：Enter the QC interface to run quality control operation.
Cal：Enter the calibration interface to run calibration operation.
Setup：Enter the setup interface to set system parameters.

The second set:

Figure 3-9B Function Button 2

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Chapter 3 System and Function

Next sample: Create a new sample ID and edit it.

Mode switch: Switch the counting mode to ‘Rout. Blood’, ‘Retic. test’ or ‘Retic.
Back. ’. Switch the blood mode to whole blood sampling mode or diluent mode,
switch the analysis mode to CBC, CBC+5DIFF or CBC+5DIFF+RRBC.
Audit: audit the sample.
Draining: draining approximately 500 ul of diluent. It can only be used in diluent
mode.
Prime: cleaning fluid system.

The third set:

Figure 3-9C Function Button 3

Pre.record: to see the last record.

Next record: to see the next record. If the current record is the last one, it shows
gray.
Audit: audit the sample.
Edit result: modify sample results.
Print: print the sample results.
Transmit: transmit sample data.
（6） Prompt area of abnormal results
Display abnormal results.

（7）Graphic display area

Display the scatter diagram and histogram.

3.6 Reagents, Control Materials and Calibrators

The reagent is configured specifically for the analyzer flow system in order to
provide optimal system performance. Each analyzer is checked at the factory
using the specified reagents and all performance claims were generated using
these reagents. Thus non-analyzer reagents may affect analyzer performance,
or result in serious mistakes, even accidents. Reagents mentioned in this

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Chapter 3 System and Function

Manual refer to the assorted reagents of the analyzer.

NOTE
 Reagents must be stored at room temperature to ensure optimal
performance. All reagents should be protected from direct sunlight,
undercooling and overheating during storage.
 The blank test should be done after the replacement of diluent, detergent,
sheath or lyse to ensure it is within the normal range.
 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.

3.6.1 Diluent

Diluent is a kind of tasteless transparent isotonic solution which is 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 to obtain accurate count and
size.
(3) Clean WBC and RBC micro-aperture and fluid system.
(4) Provide a conductive environment for testing.
Validity period: Keep diluent under 5℃~35℃ after opening. Use it within validity
period labeled in operation manual.
Once opened (connected to the analyzer), the product shelf life is only 60 days.

3.6.2 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

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Chapter 3 System and Function

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, the RBC and sheath have the same refractive index, and it
showed under the laser virtually.
Validity period: Keep sheath under 5℃~35℃ after opening. Use it within validity
period labeled in operation manual.
Once opened (connected to the analyzer), the product shelf life is only 60 days.

3.6.3 Lyse

Lyse is a kind of new reagent without azide and cyanide. 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 around the 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.
Validity period: Keep lyse under 5℃~35℃ after opening. Use it within validity
period labeled in operation manual.
Once opened (connected to the analyzer), the product shelf life is only 60 days.

3.6.4 Detergent

Detergent contains active protease which can eliminate protein aggregation so

as to clean WBC cup and RBC cup and fluid system, and prevent clogging.

Validity period: Keep detergent under 5℃~35℃ after opening. Use it within
validity period labeled in operation manual.
Once opened (connected to the analyzer), the product shelf life is only 60 days.

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Chapter 3 System and Function

3.6.5 Probe Cleaner

The probe cleaner contains potent oxide that can clear protein so as to solve
the problems of WBC and RBC cups clogging.

WARNING
 Detergent and probe cleaner are 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.

3.6.6 Control Material and Calibrator

Control material and calibrator are for analyzer quality testing and calibration.
Control material is an industrial production of whole blood. It is a hematology
reference control used in monitoring determinations of blood cell values on
hematology analyzers.There are three kinds of control materials: low, normal
and high value. These three kinds 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 material
and calibrator for use and storage methods.
The control material and calibrator mentioned in this manual refer to the special
control material and calibrator assigned by supplier. Users can purchase from
supplier or agents designated by supplier.
.

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 Chapter 4 Installation

4.1 Overview

CAUTION

 Environment Requirements
 Temperature: 15℃~ 35℃
 Relative humidity: 30%~85%
 Place the analyzer on a smooth and big enough platform which is easy to
operate. Away from direct sunlight.
 Try to use a separate AC outlet, and install stabilized voltage supply or
UPS (Uninterruptible Power Supply). Do not share an AC outlet with
centrifuges, room temperature shower (thermostat), refrigerators, air
conditioners or ultrasonic cleaning equipment or other equipment which
may interfere with the analyzer.

WARNING
 Being installed and unpacked the analyzer by an unauthorized or
untrained person could result in personal injury and instrument damage.
Never attempt to install and unpack the analyzer without a supplier
authorized representative.

This analyzer has been tested strictly before delivery. It has been carefully
packed before transporting in order to avoid damage. Check the package
carefully to see whether there is a physical damage when arrive. If damaged,
please immediately contact our after-sale service department or local agent.

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Chapter 4 Installation

4.2 Unpacking and Inspection

Take out the analyzer and accessories from shipping carton carefully, and
keep the packing material for future transport or storage.
(1) Count accessories according to the packing list.
(2) Check if there is leakage or soakage.
(3) Check if there is mechanical damage.
(4) Check all exposed lead, inserts and accessories.
Please contact our after-sale service department or local agent if any problem
occurs.

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) Near the power supply.
(2) Eight inches of space behind the analyzer must be left for air flow.
(3) 50 cm of space at least 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

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Chapter 4 Installation

WARNING
 Analyzer should be used in the condition of well ground connection for
ensuring accuracy of analyzer and safety of operator.
 A fluctuated voltage would impair performance and reliability of the
analyzer. Proper action such as the installation of AC manostat (not
provided by supplier) should be taken before operation.
 Frequent power failure shall seriously decrease the performance and
reliability of the analyzer. Proper action such as the installation of UPS
(not provided by supplier) should be taken before operation.

4.5 Environment Requirements

(1) Temperature: 15℃~35℃(Optimum temperature is 25℃)

(2) Relative humidity: 30% ~ 85%
(3) It’s recommended to install air conditioner.
(4) Avoid using the analyzer 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 analyzer by
producing high frequency electric wave.
(8)Electromagnetic compatibility design for class B of group1, electromagnetic
environment assessment should be carried out before use.

WARNING
 The analyzer takes full account of the electromagnetic compatibility

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Chapter 4 Installation

problems. The electromagnetic interference generated by analyzer does

not disturb itself and devices nearby. If the test result has a large
deviation, please check whether the analyzer is placed near an
electromagnetic field or a short wave radioactive source (radar, X ray,
centrifuge, scanner, cell phone etc.

4.6 Waste Requirements

For every 20L waste, it is recommended to add the following chemicals into
waste containers.
(1) 50ml sodium hydroxide solution (200g / L) to prevent gas forming.
(2) 250ml sodium hypochlorite solution (12% chlorine) to handle the waste
biological risk.

WARNING

 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.

4.7 System Installation

4.7.1 Tubing Installation

There are five liquid interfaces on the rear panel, which are DETERGENT,
DILUENT, LYSE, SHEATH and WASTE. Each of them is wrapped with a cap

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Chapter 4 Installation

to avoid contamination by the supplier before delivery. Uncover and set the
caps aside carefully for further use on initial installation.

NOTE
 After installation, all tubes should be in a nature relaxed state and without
distortion.
 Using tools for tubing installation is prohibitive. Only installing by hand is
allowed.
 The reagent cannot be used if the container is damaged or leaked, or if it
exceeds the shelf life. Please contact local suppliers or after-sale service
department directly.
 To ensure safety and take optimal system performance into account,
manufacturers recommend that all reagents should be placed on the
same base and lower than analyzer.

1. LYSE Tubing Installation

Take out the lyse inlet tube with red faucet from the accessories box, and
inset it to the LYSE interface on the rear panel. Place the other end of the
tube into the lyse container and twist the cap tightly.

2. DILUENT Tubing Installation

Take out the diluent inlet tube with blue faucet from the accessories box,
and inset it to the DILUENT interface on the rear panel. Place the other end of
the tube into the diluent container and twist the cap tightly.

3. DETERGENT Tubing Installation

Take out the detergent inlet tube with green faucet from the accessories box,
and inset it to the DETERGENT interface on the rear panel. Place the other
end of the tube into the detergent container and twist the cap tightly.

4. SHEATH Tubing Installation

Take out the sheath inlet tube with yellow faucet from the accessories box,
and inset it to the SHEATH interface on the rear panel. Place the other end of

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Chapter 4 Installation

the tube into the sheath container and twist the cap tightly.

5. WASTE Tubing Installation

Take out the waste outlet tube with faucet from the accessories box, and inset
it to the interface on the rear panel. Inset BNC plug to the SENSOR interface
on the left panel. Tightly twist the tube’s cap clockwise onto the waste
container. Place the waster container on the level at least 50cm lower than
the analyzer.

4.7.2 Printer Installation

Please install the printer according to the following steps.

1. Place the printer near to the analyzer so as to operate easily and put other
reference manuals.
2. Take out the printer from the package.
3. Check the printer. If it’s damaged, please contact supplier.
4. Check that the printer power is off.
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

Before storage for a long time or transportation, please run the "Prepare
Shipping" procedure. Please refer to Chapter 10 Service for details. Operating
steps are as follows.
1. Select "Prepare Shipping" in "Maint" interface.
2. Follow the prompts to unplug the relevant tube connectors.
3. Analyzer starts to empty tubes.
4. Shut down the analyzer after emptying.
5. Keep all reagents’ tubes well.

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Chapter 4 Installation

NOTE
 Storage temperature: -10℃~ 55℃
 Relative Humidity: ≤ 95%
 Atmospheric pressure: 50kPa-106kPa
 Before delivery, external disinfection is needed.

37
 Chapter 5 Principles of Operation

5.1 Overview

URIT-5160 uses electrical impedance method (also known as Coulter

principle) to detect RBC and PLT count and volume distribution, colorimetry to
measure HGB concentration, multi-angle laser light scattering method to do
WBC five part differential. Three separated channels are used for getting the
blood cells counting results respectively.
(1) Five part differential data are detected by laser in sheath flow regulator.
(2) HGB is measured by colorimetry in WBC/HGB cup.
(3) The data of RBC and PLT is detected by electrical impedance analysis in
RBC cup.
The analyzer aspirates, dilutes and mixes the samples and then detects
parameters in each counting process.

5.2 Sample Aspiration

Analyzer supports two modes of blood cell counting analysis.

1. Whole blood sampling mode
2. Diluent sampling mode
The sample volumes:
Whole blood sampling: 20µL
Diluent sampling: 20 µL
The whole blood sample is aspirated into the analyzer by the precision
stepper motor and distributed into different measuring channels.

5.3 Sample Dilution

The sample is divided into three parts after being aspirated. These three
samples go to the WBC counting chambers, RBC counting chambers and
WOC cup respectively, and react with different reagents. Finally results of

38
Chapter 5 Principles of Operation

WBC count/HGB measurement, RBC/PLT count and WBC five part

differential are obtained.

5.3.1 Whole Blood Sampling & 5Diff

（1）WBC / HGB Dilution Process

Whole Blood Sample 10μL

Add 2500μL Diluent

Dilution ratio is approximately 1:251

（2）RBC / PLT Dilution Process

Whole Blood Sample 10μL

Add 2500μL Diluent

Pre-mixing Dilution Ratio is approximately

1:251

Pre-mixing specimen 25μL

Add 2400μL Diluent

Dilution ratio is approximately 1:24347

（3）WBC Differential Dilution Process

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Chapter 5 Principles of Operation

Whole Blood Sample 10μL

Add 1100μL Sheath

Dilution ratio is approximately 1:111

5.3.2 Pre-diluent CBC & 5Diff

（1）WBC / HGB Dilution Process

Peripheral blood samples 20μL

Add 500μL Diluent

Dilution ratio is approximately 1:26

140μL specimen for WBC/HGB test

（2）RBC / PLT Dilution Process

Peripheral blood samples 20μL

Add 500μL Diluent

液
Dilution ratio is approximately 1:26

140μL specimen pre-mixing in WBC cup Add 2200μL Diluent

45μL specimen in RBC cup

（3）WBC Differential Dilution Process

40
Chapter 5 Principles of Operation

Peripheral blood samples 20μL

Add 500μL Diluent

Dilution ratio is approximately 1:26

80μL specimen for WBC differential test

5.4 WBC Test Principle

5.4.1 Multi-Angle Laser Light Scattering Technology

Figure 5-1 Sheath Flow Regulator

The whole blood samples are diluted in an appropriate proportion with sheath,
and 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. Scattered
light intensity of different types of cells from every angles is different due to

41
Chapter 5 Principles of Operation

the differences of cell size, cell membrane and cell internal structure.
Scattered light signals received by photodetector at each angle are converted
into pulse signals with different amplitudes. By analyzing the pulse signals of
different angles, we can get the scatter diagram which represents the cell
volume and related information. WBC are classified by the distribution of the
pulse signals and the scatter diagram.

Figure 5-2 Scatter Diagram

The gray area is the ghost cells. It reflects that RBC dissolve into pieces on
the scatter diagram; green is lymphocyte group; pink is monocyte group; blue
is neutrophil; white is basophil group; red is eosinophil group.

5.4.2 WBC Differential

The analyzer divides the WBC into basophil, eosinophil, monocyte, neutrophil
and lymphocyte via Multi-Angle scatter analysis as the WBC going through
the sheath flow regulator. The default unit of cell amounts is 10^9/L.

 White Blood Cell Number

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Chapter 5 Principles of Operation

Get the value of WOC and WBC simultaneously by laser and

electrical impedance methods

 Lymphocyte Number (Lym#)

 Lymphocyte Percent

Lym% = Lym#/WBC

 Monocyte Number (Mon#)

 Monocyte Percent

Mon% = Mon# /WBC

 Neutrophil Number (Neu#)

 Neutrophil Percent

Neu%=Neu#/WBC

 Eosinophil Number (Eos#)

 Eosinophil Percent

Eos%=Eos#/WBC

 Basophil Number( Baso#)

 Basophil Percent

Baso%=Baso#/WBC

5.5 Test Principle of Hemoglobin Concentration

5.5.1 Colorimetry Principle

Adding lyse into the diluted sample in WBC cup, RBC dissolves and
hemoglobin is released. The hemoglobin combines with lyse to form
hemoglobin complex which is illuminated by the LED light-emitting diode with
a 540nm-wavelength monochromatic light at one end of the WBC cup. The
transmitted light at the other end is received by the optical tube, and the light
intensity signal is converted into voltage signal after amplifying. Compare it
with the voltage generated by the transmission light intensity before adding

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Chapter 5 Principles of Operation

the sample into the colorimetry chamber (only with diluent), the hemoglobin
concentration is obtained. Hemoglobin concentration is proportional to the
sample absorbance in 540nm wavelength. The process of measurement and
calculation is done automatically by the analyzer, and relevant results is
displayed in the analysis results area.

5.5.2 HGB Parameter

Hemoglobin (HGB) concentration is calculated by the following

formula.

( )；
EB
HGB=K×Ln
ES

5.6 RBC /PLT Test Principle

5.6.1 Electrical Impedance Principle

The analyzer uses the traditional electrical impedance for the blood cells
measurement and count. As shown in Figure 5-3, conductive liquid (mainly
diluent) provides constant current source for electrode to help the circuit form
a stable impedance loop. When cells pass through the pores, the conductive
liquid is substituted by cells, and the resistance of loop changes to produce
electrical pulses. As different volumes of cells passing through the pore,
different electrical pulses amplitude is generated. The number and size of
cells are determined according to the number and amplitude of electrical
pulses.
The number of pulses corresponds to the number of cells pass through the
pores, and 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 RBC, WBC, PLT and other groups
in accordance with pre-set volume classification procedure.

44
Chapter 5 Principles of Operation

Figure 5-3 Electrical Impedance

5.6.2 Volume Measuring

Figure 5-4 Volume Metering

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Chapter 5 Principles of Operation

The volume measuring unit controls the sample volume passing through the
pore during counting to obtain the exact counting results in quantitative
samples. The volume measuring unit includes metering tube and two
photoelectric sensors.

As shown in Figure 5-4, empty the metering tube before testing. The liquid
level of metering tube declines slowly as the sample passing through the
pore. When the liquid level passes through the start detector, one electrical
signal generates, and the analyzer starts counting. When the liquid level
reaches the stop detector, it also generates an electrical signal, then the
counting finishes. If there were bubbles or other abnormal stream in the fluid
system, "bubble" or "clog" alarm pops up. Please refer to Chapter 11
Troubleshooting.

5.6.3 RBC Parameters

 RBC Number
The analyzer gets the number of red blood cell (RBC) by measuring the
corresponding electrical pulse numbers of RBC directly. The unit is 10^12/L.

RBC = n ×10^12 / L
 MCV
The mean corpuscular volume (MCV) is the average volume of individual red
blood cells. MCV is derived from the RBC size distribution data. The unit is fL.
 HCT
The hematocrit (HCT) is the ratio of red blood cells to plasma. It is expressed
as a percentage of the whole blood volume. HCT is calculated from the RBC
count and the MCV as follows.

 MCH
The mean corpuscular hemoglobin (MCH) is the average amount of

46
Chapter 5 Principles of Operation

hemoglobin in the red blood cell and is expressed in unit of pg. MCH is
calculated from the RBC and the HGB as follows.

 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.

 RDW-CV
The RDW-CV is derived from the RBC histogram and is expressed as
percent.
 RDW-SD
The RDW-SD is the width of 20% peak value of red blood cell distribution
histogram .The unit is fL.

 RBC Distribution Width

The RBC Distribution Width (RDW) is gotten from the RBC histogram. It is the
geometric standard deviation of RBC volume distribution (10 GSD).

5.6.4 PLT Parameters

 PLT Number
The analyzer gets the number of platelet (PLT) by measuring the

47
Chapter 5 Principles of Operation

corresponding electrical pulses of RBC directly. The unit is 10^9/L.

PLT = n ×10^9/ L

 MPV
The mean platelet volume (MPV) is calculated according to PLT histogram.
The unit is fL.
 PDW
The platelet distribution width (PDW) is gotten from the PLT histogram. It is
the geometric standard deviation of PLT volume distribution (10 GSD).
 PCT
The PCT is calculated as follows. The unit of PLT is 10^9/L. The unit of MPV
is fL.

5.7 Principles of Reticulocyte Analysis

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. The RNA can be considered as a kind of in vitro
cationic dyes which simultaneously stain and precipitate the polyanion to form
a net or reticulum.

5.7.1 RBC Development Process

The development process of RBC system in skeleton is : multipotential stem

cells→monopotential stem cells→prorubricyte→polychromatic
erythroblast→metarubricyte→reticulocyte→mature erythrocyte. So
reticulocyte is a immature red blood cell which has taken off cell nucleus, and
it’s a phase of RBC development process.

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Chapter 5 Principles of Operation

5.7.2 Characteristics of Reticulocyte

1.It contains ribosome（RNA）-- a kind of alkaline matter containing

dotted or net structure.
2.After reticulocyte is vital stained by brilliant crystal blue, the dotted
or net structure will be stained blue.
3.The reticulocyte in blood circulation takes about 24-48 hours to
mature.

Figure 5-6 Dyed Reticulocytes

5.7.3 Testing Principle of Reticulocyte

Reticulocytes contain alkaline matter RNA which have dotted or net

structures, but mature RBC hasn’t. For this reason, we can distinguish mature
RBC and reticulocyte, as Figure 5-6.
Stain samples firstly:

RET The dotted or net

substances have
being stained blue.

RBC
Unstained

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Chapter 5 Principles of Operation

Figure 5-7 Staining

Illuminated with polarized light, the stained dotted or net substances will
strengthen scatted light on wide-angle direction:

Figure 5-8 Cells scatting of light

RBC and reticulocyte have the same laser scattering characteristics at 0 and
10 degrees. But Illuminated with polarized light at 90 degrees, reticulocytes
have different light scattering characteristics, so they can be distinguished.
When optical signal transforms to electrical signal, it can be distinguished in
scatter diagram visually.

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Chapter 5 Principles of Operation

RET Mature RBC WBC

Figure 5-9 RETIC scatter diagram

5.7.4 RETIC_ABS

RETIC_ABS is the concentration of RETIC. It equals to the ratio of RETIC to

RBC multiplies by RBC concentration:

5.7.5 IRF

IRF has more RNA than mature reticulocytes and absorb more stain. So their
wide-angle scattering light signal is larger. IRF is classified as reticulocyte
population which exceeds preconcerted scattering threshold, as the purple
part in Figure 5-8.

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Chapter 5 Principles of Operation

The IRF was initially designated as the Reticulocyte Maturation Index (RMI),
and defined by NCCLS H44-A 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.

1) Monitor hemopoietic regeneration after bone marrow transplant,
hemopoietic stem cell transplantation, or intensive chemotherapy
2) Monitor bone marrow toxic insults from drugs (for example, AZT)
3) Monitor erythropoietin therapy in renal failure, AIDS, infants,
myelodysplastic syndromes and blood donations
4) Classify anemia
5) Monitor efficacy of anemia therapy (Fe, B12 and Folate)

NOTE
 There is no reticulocyte test mode in specific machines.

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 Chapter 6 Settings

6.1 Overview

Initialization setting of analyzer has been done before delivery. Setting of the

interface at the first boot is default. To meet the different needs, some

parameters can be reset.

6.2 Settings

Click “Setup” to enter setting interface, see Figure 6-1.

Figure 6-1 Setup Interface

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Chapter 6 Settings

6.3 System Maintenance

Click “Maintenance” to enter maintenance interface, see Figure 6-2.

Figure 6-2 Maintenance

Change lyse: click it to prime lyse automatically after replacement.

Change diluent: click it to prime diluent automatically after replacement.

Change detergent: click it to prime detergent automatically after replacement.

Change sheath: click it to prime sheath automatically after replacement.

Cauterize aperture: click this button to eliminate clogging.

Flush aperture: click this button to eliminate clogging.

Soak impedance transducer: click this button as it clogging or getting high

blank test result.

Soak sheath flow regulator: click this button to clean inner wall of sheath flow

54
Chapter 6 Settings

regulator.

Empty transducer：click this button to empty the transducer.

Rinse impedance channel: click it to clean the impedance channels.

Rinse optics channel: click it to clean the optical channels.

Prepare shipping: perform this function before shipping or unused for a long

time to empty fluid in the tubing.

6.4 X-B QC

Click “X-B QC” to enter QC interface. Please refer to Chapter 7 for details.

6.5 X-R QC

Click “X-R QC” to enter QC interface. Please refer to Chapter 7 for details.

6.6 X QC

Click “X QC” to enter QC interface. Please refer to Chapter 7 for details.

6.7 Limit

Click “Limit” to enter the interface. See Figure 6-3.

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Chapter 6 Settings

Figure 6-3 Limits

Click “Group” to choose patient group, including male, female, children,

newborns, infants, General, Custom 1, Custom 2 and Custom 3. See Figure

6-4.

Figure 6-4 Limits

Click “Default” to restore factory settings, for example, click “Default” in group

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Chapter 6 Settings

of Male, “Male” limits restore to factory settings.

Click “Save” to save the edited limits.

Click “Export” to export current group limits.

Click “Print” to print current group limits.

Click “Return” to go back to setting interface.

6.8 Time

Click “Time” to enter setting interface of time and date.

There are three formats of date, which are YYYY-MM-DD, MM-DD-YYYY and

DD-MM-YYYY. Y indicates Year, M indicates Month and D indicates Day. See

Figure 6-5.

Date display format changes according to date format.

Click “OK” to save the modified settings.

Figure 6-5 Time and Date

6.9 Parameter

Click “Param.” to enter the interface. See Figure 6-6.

Choose unit of WBC, RBC, PLT, HGB/MCHC and HCT.

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Chapter 6 Settings

Select the representation of IRF as a decimal or percentage.

Modify the reaction time of RRBC: Click “Default” to restore RRBC reaction

time to factory settings.

Click “OK” to save modified setting.

Figure 6-6 Parameters

6.10 Print

Click “Print” to enter the interface. See Figure 6-7.

Printer type: USB port printer (A5), USB port printer (A4).

Print format: print with histogram, or print without histogram

Auto print: turn on/off auto print. If it’s on, test result is printed automatically

after counting. If it’s off, it needs to manual print.

Color: color, or grayscale.

Print title: input hospital name here, and the hospital name will be displayed.

Click “OK” to save the modified settings.

TOP margin: enter the distance of top margin. Unit: pixel, 1inch=72 pixels.

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Chapter 6 Settings

Print List: indicates the state of the print list. Including ID, Content, Printer,

Submist Time, Status.

Figure 6-7 Print

6.11 Transmit

Click “Transmit” to enter the interface as shown in Figure 6-8.

Ethernet port setup: set the local IP, server IP, local mask, local gateway and

port number as connecting with LIS system. The native mask and the local

gateway can be selected by default, the others shall be reset.

Transmission setting: select either “On” or “Off” auto transmit as connecting

with LIS system. “Trans Histo”, “Trans Scatter”, “Trans Mode” and “Trans

Select” can be selected.

Serial Port: the default port is /dev/ttyO0. Rate can be set from 110 to 115200.

The number of “StopBit” and “DataBits”, the parity checking can also be set.

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Chapter 6 Settings

Figure 6-8 Transmit

NOTE

 Serial port applies to specific machines only.

6.12 Maintenance Setting

Click “Maint.Set” to enter the interface. See Figure 6-9.

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Chapter 6 Settings

Figure 6-9 Maint. Set

Auto blank: click to select “On” or “Off” and then click “OK” to save

settings as blank test is necessary in each boot. The analyzer does not

perform it if it is “Off”.

Auto clean: the analyzer does not perform it if it is “Off”. Click to select

“Auto clean” and choose times (50 times, 75 times, 100 times, 125 times and

150 times) according to your necessary. Auto clean is performed after 50

sample testing, if 50 times is selected. If the analyzer is shut down in the

condition of sample test times being less than 50, the analyzer shall re-count

after rebooting.

Diluent reminders: dialog box pops up in each counting if “On” is selected.

Auto sleep: the analyzer automatically enters the dormant state if there is not

any operation for some time. Users can adjust dormancy length according to

the necessary.

Soak and exit: prompts will not pop up if “ Off” is selected. Soaking is

performed when shutting down, if “On” is selected. The analyzer prompts to

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Chapter 6 Settings

put the detergent under the sample probe to aspirate it for soaking sample

cup. Shut down the analyzer after soaking.

Auto soak: click to choose times. The analyzer reminds users to put

detergent under the sample probe, when counting times is over selected

times.

6.13 Version

Click “Version” to pop up version dialog. See Figure 6-10.

The current version information is displayed here. Version upgrade can be

achieved.

Click “Return” to enter setting interface.

Figure 6-10 Version Information

6.14 User

Click “User” to enter the interface. See Figure 6-11.

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Chapter 6 Settings

Figure 6-11 User

Click “Delete” to delete selected user.

Click “Add” to pop up “Add user” dialog. New user’s username, name,

password and group can be edited. “Group” is divided into “Ordinary user”

and “Administrator”, which are given different permissions. The administrator's

permissions are higher than Ordinary user’s. Administrator can operate all the

functions, while the ordinary user can not delete data, export data and

calibrate the analyzer. See Figure 6-12.

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Chapter 6 Settings

Figure 6-12 Add User

6.15 Service

Click “Service” to pop up the following dialog. Only the supplier service

engineers can perform this function in maintenance.

Figure 6-13 Service

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Chapter 6 Settings

6.16 Reagent

Click “Setup” when replacing new reagent. Click “Reagent” to pop up below

dialog. See Figure 6-14.

The activation date, total amount, Lot, valid period and remaining amount of

lyse, sheath, diluent and detergent are displayed here. For example, click

“Replace” of diluent when replacing diluent, see the popup dialog in Figure 6-

15.

Take out the diluent activation card from the diluent container and click

“Activate”. 15 seconds countdown starts. Put the IC card onto card reader and

there is a "tick" sound, which means successful card read. Successful

activation displays in dialog box. The activation date is the current date after

activating. The valid period is three months. The total amount of reagents

returns to the same amount as the reagents themselves. The remaining

amount subtracts the amount consumed by the analyzer during operation.

The activation method of other reagents is the same as diluent.

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Chapter 6 Settings

Figure 6-14 Reagents

Figure 6-15 Activation

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Chapter 6 Settings

6.17 System Log

Click ”System log” ， we can check the warnings and the status of the

instrument and so on.See figure 6-16.

figure 6-16 System log

6.18 Display

Click “Display” to choose the parameters to display or print, which depends on

our requirement. See figure 6-17.

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Chapter 6 Settings

figure6-17 Display

NOTE

 Transmit parameter 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 supplier engineers.

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 Chapter 7 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

Sample Preparation

Data Input

Sample Count

Result Query and Output

Statistical Analysis

Shutoff

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Chapter 7 Daily Operation

Note
 The analyzer must be operated by medical inspection professionals,
trained doctors and technicians.

7.2 Preparations

Check the analyzer as the following steps before startup.

1. Check the Waste Container
The waste should be handled properly and cleaned up before startup every
day.
2. Check the Reagents, Tubing and Power
Check if diluent, lyse, detergent and sheath meet the test requirements.
Check if the tubing of reagents and waste connected well and without
bending.
Check if the power plugs is inserted power outlet safely.
3. Check the Printer
Check if printing paper is sufficient and the installation is proper.
Check if the power plugs is inserted power outlet and the cable has been
connected with the analyzer properly.

WARNING

 All clinical specimens, control materials, calibrators and wastes have

potential infectious hazard. Operator should comply with the safe
operation provisions in laboratory and wear personal protective equipment
(lab coats, gloves etc.) when handling these materials.

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Chapter 7 Daily Operation

7.3 Startup

Turn on the power switch on the left panel, then the status indicator on the
front panel turns orange. The analyzer automatically checks the operation of
the components when self-checking and initialization after loading. Then it
rinses the fluid system. It takes about 4 minutes to finish this process. Status
indicator turns blue after initialization. See Figure 7-1.

Figure 7-1 Login

Virtual keyboard pops up as entering password and user’s name. See Figure
7-2.

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Chapter 7 Daily Operation

Figure 7-2 Virtual keyboard

The analyzer enters test interface after entering password and username. See
Figure 7-3.

Figure 7-3 Test Interface

After startup, blank test should be done before sample test. Operator can set
to run it automatically after startup, see Chapter 6 Settings for details. The
acceptable range of blank test is listed in Table 7-1.
Table 7-1 Range of blank Test

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Chapter 7 Daily Operation

Parameter Acceptable range

WBC ≤0.20x10∧9 /L
RBC ≤0.02x10∧12 /L
HGB ≤1g /L
PLT ≤10.0x10∧9 /L

If the blank result is out of this range, please repeat the above procedures
until it is in this range. If the results are still out of this range after repeating
five times, please refer to Section 11.4.2 of Chapter 11 Troubleshooting.

7.4 Quality Control

Quality Control should be performed before daily test for accurate results.
Please refer to Chapter 8 Quality Control.

7.5 Collection of Blood Samples

WARNING

 All clinical specimens, control materials and calibrators may contain

human blood or serum and are potentially infectious, so wear lab coats,
gloves and safety glasses and follow the established laboratory or clinical
procedures when handling these materials.
 Do not directly touch blood samples, control materials or calibrators.
Please handle these in accordance with related operating rules.

Note
 Blood collection and disposal should be performed according to the local
and national environmental regulations or laboratory’s requirements.
 Ensure the whole procedure of blood collection is clean and
contamination-free. All specimens must be properly collected in tubes

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Chapter 7 Daily Operation

containing the EDTA (EDTA-K2·2H2O) anticoagulant.

 Do not shake the sample tube violently.
 Venous blood can only be stored for 4 hours at room temperature. It’s
recommended to keep blood sample at the temperature between
2℃~8℃for longer storage.

7.5.1 Whole blood collection

Collect whole blood sample by vein-puncture and store it in a clean sample

tube which contains EDTA-K2·2H2O (1.5~2.2mg/mL). The EDTA-K2·2H2O
can keep the shape of WBC and RBC, and inhibit PLT aggregation. Gently
shake the tube 5~10 times and ensure to mix it 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. It’s also used when there a suspected false
thrombocytopenia caused by EDTA.
3. ACD and CPDA
It’s widely used in cell concentration (especially platelet concentrates), but
not used for cell counts.
4. EDTA
For the salt of EDTA, use EDTA K2 （ United States and Japan ） and
EDTA K3 （ United States and Europe ） ,sometimes NA2EDTA.
Recommend by ISCH in1993, EDTA K2 and EDTA K3 are most widely
used in the blood test of the world. But other EDTA salts can also be
used. EDTA could lead to false thrombocytopenia through platelet
aggregation. (Incidence rate is about 1/800)

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Chapter 7 Daily Operation

5. Fluoride
Use before EDTA. Without side effects according to the survey.

7.5.2 Diluent Sample Preparation

1． Set the current test mode to “Diluent” in “Test” interface, as shown in

Figure 7-4.

Figure7-4 Mode Switch Operations

2． Put a clean test tube under the sample probe, and press “Drain” button on
front panel. 500 μL diluent is drained from sample probe automatically. It is
recommended to put the test tube close to the sample probe, so as to
avoid bubbles or spillage.
3． Please quickly inject the sampled 20uL peripheral blood into the test tube
filled with diluents and mix it well.

Note
 Prevent the prepared diluent from dust; otherwise it may cause analytical
error.
 After full reaction of peripheral blood and diluent, it should be placed for 3
minutes, and then remix it before test.

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Chapter 7 Daily Operation

 Ensure that the sample is analyzed within 30 minutes after dilution,

otherwise the analysis results are not reliable.
 Each laboratory should evaluate the stability of the results according to
their sample number, sampling method and the technical level in diluent
mode.

7.5.3 Stability of Samples

It’s recommended to use fresh whole blood. ICSH (International Committee

for Standardization of Hematology) defined fresh blood as samples which is
processed within 4 hours of collecting. Mix the whole blood samples well and
place it in EDTA-tubes. The accuracy of each parameter is the highest when
the sample is tested within 8 hours of collecting. If the sample is tested within
5 to 20minutes or over 8 hours of collecting, the WBC volume distribution will
offset.

7.6 Create Next Blood Sample

Next sample can be created in blood cell analysis window. User can either
input detailed sample information before sample analysis or after sample
analysis. See Figure 7-5.

Figure7-5 New Next Blood Sample

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Chapter 7 Daily Operation

The system provides English input method. Click the corresponding input box
and the virtual keyboard pops up. If necessary, external keyboard with PS2 or
USB interface can be connected to help enter information. See Figure 7-6.

Figure7-6 Virtual keyboard

Name: input patients’ name

Gender: male and female. It’s blank by default.
Age: year, month, day and hour can be selected.
Blood Type: A, B, O, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-, O
Rh+ and O Rh- can be selected. The default is blank.
Group: divided into male, female, Children, infants, newborns, general,
Custom 1, Custom 2 and Custom 3.
System automatically selects corresponding group as age and gender are
input. The reference values are listed as Table 7-2.
Table 7-2 Reference Value
Reference Value Age Gender
General NO input Blank, Male, Female
General ≥16 years Blank
Male ≥16 years Male
Female ≥16 years Female
Children >1 month and ＜16 Blank, Male, Female
years
Infants >1 month and ＜1 Blank, Male, Female

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Chapter 7 Daily Operation

years
Newborns <1 month Blank, Male, Female
ID: Only numbers can be input here. If there’s no SN input, the analyzer
automatically plus 1 on the basis of the last SN and take it as the new SN.
Case ID: Input the case number.
BarCode: Input bar code.
Bed ID: Input bed ID.
Dept.: Input department name or SN code.
Sender: Input sender’s name or code.
Patient type: Select the patient type, in which outpatient, hospital, physical
examination or emergency can be selected.
Sampling time: Input the blood sample collection time.
Send time: Time of sending sample to the department.

NOTE
 The SN 0 is the special one of blank test. Please do not input 0 in sample
test.

CAUTION
 Each sample has a corresponding identification number. Do not confuse.

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7.7 Sample Test

7.7.1 Mode

Click "Mode switch" in test interface to choose needed blood mode and
analysis mode. See Figure 7-7.

Figure7-7 Mode Switch

Click “OK” to save settings.

NOTE
 CBC can be chosen both in “Whole Blood” and “Diluent”. CBC mode-- is
only for WBC counting but without five part differentials. The counting
result includes 14 parameters and the histograms of RBC and PLT.
"CBC+5Diff"--- For WBC counting and five part differentials.
 "CBC+5Diff+RRBC"--- For counting after dissolving the indissolvable red
blood cells. It is suggested that when RRBC? alarm appears, switch
counting mode to CBC+5Diff+RRBC, and then run counting again so as to
eliminate the interference from indissolvable red blood cells. If WBC total
number is much less than that of the first counting, it shows that this
specimen contains indissolvable red blood cells.

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7.7.2 Process of Counting and Analysis

WARNING
 The sharp sample probe may contain blood samples, quality controls or
calibrators which probably have potential infectivity. Do not directly touch
the sample probe.

CAUTION
 Do not reuse disposables.
 Ensure the inputted ID number corresponds with the sample.

NOTE
 Please use the specified vacuum blood tube, centrifuge tube, capillary
tube and other disposable products when collect the blood sample.
 Don’t open the front shell after start counting.

7.8 Data Query

After each counting, the results are automatically saved in a database that
could store at least 200,000 results include 35 parameters(including 2 scatter
diagrams and 2 histograms).Operator could review all of the results, scatter
diagrams and histograms that store in the database through query and
statistics.

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7.8.1 Data Query

Click “Data” to enter the query interface. See Figure 7-8.

Figure 7-8 Data Query

Click “Query” to pop up the following dialog box. See Figure 7-9.

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Chapter 7 Daily Operation

Figure 7-9 Query

Data query: quick query, conditional query

 Quick query
Unchecked: display current unaudited sample
Unprinted: display current unprinted sample
No transmitted: display current not transmitted sample
 Conditional query
You can query according to ID, Name, Case ID, or the range of selected ID
and test data.
For more precise query, you can use conditional query and quick query
together.

7.8.2 Data selection

There’s a “*” in front of selected ID. As shown in Figure 7-10, the ID of

selected sample is 000000000004. Click “Graph Review” to see detailed data
and graphs. See Figure 7-10.

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Chapter 7 Daily Operation

Figure 7-10 Detailed Data

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 termly. Both delete all and delete one are
available. Click “Delete” to delete chosen data.

NOTE
 Be aware that once the data are deleted, it can NOT be recovered. Please
operate with caution.

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7.9 Reticulocyte analysis

NOTE
 There is no reticulocyte test mode in specific machines.

System operator can use reticulocyte software to analyze reticulocyte for

blood samples. Reticulocyte sample is a kind of blood sample diluted and
dyed by reticulocyte reagent.
In test interface, click “Mode” and “Retic. test” to start reticulocyte analysis. As
Figure 7-11:

Figure 7-11 Reticulocyte analysis interface

In reticulocyte analysis interface of analyzer system, the test result of

reticulocyte sample is reticulocyte rate，Reticulocyte absolute value and IRF.

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Chapter 7 Daily Operation

7.9.1 Preparation for reticulocyte sample

Matters need attention

1．Add 20µL blood sample into the reticulocyte reagent tube.Place it into
an incubator which the temperature inside was 35℃ for 15 minutes after
mixing enough.The blood volume should approach 20 µL as much as
possible.
2 ． Take out the sample and mix it(15 times),finish the test in 10
minutes.If take out the sample without mixing,the duration can be
lengthen to 30 minutes.

7.9.2 Reticulocyte test

The reticulocyte background shall be tested first to make sure it meets the
requirements, and then test reticulocyte.
Click “Mode” and select “Retic. back” to enter reticulocyte background
interface. See Figure 7-12:

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Chapter 7 Daily Operation

Figure 7-12 Reticulocyte background interface

In reticulocyte background interface, get the reticulocyte background

numerical value by blank test. Only when the numerical value is lower than
0.5 can reticulocyte be tested. If the value is higher than 0.5, blank test shall
be made again until reticulocyte background meets requirement.
Click “Mode” and select “Retic. test” to enter reticulocyte test interface. See
Figure 7-13;

Figure 7-13 Reticulocyte test interface

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Chapter 7 Daily Operation

WARNING
 Avoid contact skin and clothes when operator uses reticulocyte reagent.
New mathylene blue contained in the reagent can result in skin, clothes
and other surfaces pollution.

7.10 Edit Information

Choose ID and click “Edit info” to pop up dialog box, see Figure 7-14.
Click “OK” to save edit, while click “Cancel” to give up saving.
The checked sample cannot be edited. Please cancel the check first before
you edit it. Please refer to Section 7.6 Create Next Blood Sample for
information edit.

Figure 7-14 Edit Information

7.11 Export

Click “Export” to pop up the following dialog box, see Figure 7-15. Select
“Chosen record” and “All records” in “Range”, tick relevant items in “Content”.

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Chapter 7 Daily Operation

Please insert the U disk before exporting. Click “OK” to start export. The
exported data is in Excel form. Click “Cancel” to cancel export.

Figure7-15 Export

7.12 CV Value and Trend Graph

To check the CV value, please do 11 times test for one blood sample. Select
all test results except for the first one and click “CV” to display CV value. See
Figure 7-16.
Click “Trend graph” to see the trend graph of parameter. See Figure 7-17.

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Chapter 7 Daily Operation

Figure7-16 CV

Figure7-17 Trend Graph

7.13 Shutoff and Logout

Shutoff procedure should be performed after finishing all the tests and before
turning off the power. Sample cups and tubes will be cleaned by shutoff
procedure. Perform it at least once every 24 hours in continuous use or after
the whole day testing.

Shutdown Procedures
1. Click “Setup” to enter the interface.
2. Click “Shutdown” and click “OK” in popup dialog.
3. Rinse starts.
4. Turn off the power after rinsing.
Logout Procedures
1. Click “Setup” to enter the interface.
2. Click “Logout” and input new user name and password.
3. Click “OK” to login with new user name

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NOTE
 Data loss and abnormal boot may be caused if the shutoff
procedures are not performed.

90
 Chapter 8 Quality Control

8.1 Overview

In order to maintain the analyzer precision and eliminate system errors, it’s
necessary to perform quality control (QC). This analyzer provides four QC
methods, which are L-J QC mode, X-B QC mode, X-R QC mode and X QC
mode. In the following conditions, perform quality control with control
materials recommended by supplier.
1. After daily start-up procedures completed
2. The reagent lot number changed
3. After calibration
4. After maintenance, or component replacement
5. In accordance with the laboratory or clinical QC protocol
6. In suspicion of abnormal parameter value
For accurate quality control results, please pay attention to the following
items while using control materials.
1. Ensure that the control materials are stored at low temperature and
the container is not damaged.
2. Please mix the control material following manufacturer’s
recommendations.
3. Do not use it if it opened and placed in a long time (the time is longer
than recommended duration).
4. Do not heat or violently shake it.
5. Check value difference via comparison of high, normal, low control
materials of current batch with previous batch.

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Chapter 8 Quality Control

WARNING

 All clinical specimens, control materials, calibrators and wastes have

potential infectious hazard. Operator should comply with the safe
operation provisions in laboratory and wear personal protective equipment
(lab coats, gloves etc.) when handling these materials.

8.2 Quality Control Options

(1) L-J QC
L-J QC (Levey-Jennings graph) is a simple and visual QC method, with which
QC value can be drawn directly on graph after getting the Mean, SD and CV.

Mean( ), SD and CV are derived from following formulas.

__ X i
X i 1
n

1 n  __
2
SD    Xi  X 
n  1 i 1  

(2) 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 concentration, dilution,
human blood pathology and technical factor, but the volume and hemoglobin
content of every RBC or hemoglobin in specific corpuscular volume is hardly
interfered by those preceding factors. According to this characteristic, quality
control of the samples is done by surveying the value of MCV, MCH and
MCHC.
(3) X-R QC

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Chapter 8 Quality Control

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.
(4) 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 rather than one value. Based on the mean value, X , SD and CV can
be calculated.

8.3 8.3 L-J QC

Click “QC” to enter “L-J QC” interface. See Figure 8-1.

Figure 8-1 QC Interface

8.3.1 Setup

Click “Setup” to enter corresponding interface. See Figure 8-2.

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Chapter 8 Quality Control

Figure 8-2 Setup

There are 14 different QC groups can be set. Users can set several groups as
needed. Click “New” to set up one group of QC. See Figure 8-3.

Figure 8-3 Edit

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Chapter 8 Quality Control

Edit information: Lot, QC material type, QC case ID, level, runaway mode,
valid period, reference and limit
Limit Setup: calculated by absolute value and calculated by percentage, click
“Limit setup” to choose it.
Click “Return” after editing. Click “OK” in popup dialog box to save it and
return to setting interface.
Choose one group and click “Test” to test in QC interface. Click “Edit” to edit
selected group, click “Delete” to delete the selected group, and click “Empty”
to delete all groups.
Reference is the standard value of QC count. Limit gives the allowable
deviation range. Please note that the limit cannot be greater than reference,
otherwise, the new limit cannot be saved in database.
Format of valid period: year/month/day

8.3.2 QC Graph

Click “Test” after editing. Return to QC interface and start to QC count. Click
“Edit Result” to modify results. See Figure 8-4.

Figure 8-4 Edit Results

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Click “QC Graph” to check it. See Figure 8-5.

Figure 8-5 QC Graph

If there is a dot not in control area, choose it and click “Out of control” to enter
the interface. See Figure 8-6.
Choose the reasons of out of control and write it down. Click “OK” to save it.

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Figure 8-6 Out of Control

QC Graph Instruction
1. It’s a graph with times of QC count on horizontal axis and results of QC
count on vertical axis.
2. 20 dots can be displayed on each page for each parameter. Turn
another page to see other dots.
3. The above line on the graph means Reference plus limit.
4. The below line on the graph means Reference value subtract limit.
5. The 3 values on the left side of parameter graph mean
a) upper line ——Reference + limit
b) middle line ——Reference
c) lower line ——Reference –limit
If the control dot falls in the area between upper and lower limit of the
corresponding graph, it means the dot is under control; if not, the dot is out of
control. Each QC graph can only store 100 dots at most.

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8.3.3 QC List

Click “QC list” to see the tested sample data. See Figure 8-7.

Figure 8-7 QC List

There are at most 100 pieces of data can be reviewed in QC list. Click ,

, , , , , and to review test results.

Click “Delete” to delete the selected test results.

The reference and limit shown in this interface are the value inputted when
editing. The reference and limit in QC list changes according to that in editing.
QC list saves every QC test results.

8.4 X-B QC

8.4.1 X-B QC Edit

X-B QC is different to others. Only three parameters are edited ：MCV, MCH

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and MCHC.
Click “X-B QC” to pop up dialog box as shown in Figure 8-8.
Click “X-B setup” to enter edit interface. Click “On” in XB setup, the number
between 20 to 200 is available in sample number. See Figure 8-9.

Figure 8-8 X-B QC

Figure 8-9 X-B Setup

Click relevant text box to input reference and limit of MCV, MCH and MCHC.
At the same time please give the sample validity of RBC, MCV, MCH and
MCHC. It provides the upper limit and lower limit of RBC, MCV, MCH and
MCHC. The value which is within limits is valid. “Absolute value” and
“Percentage” can be selected in limit setup interface. See Figure 8-10.

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Figure 8-10 Limit Setup

Reference is the standard value of QC count. Limit gives the allowable
deviation range. Please note that the limit cannot be greater than reference,
otherwise, the new limit cannot be saved in database. Click “Return” after
setup. Click “OK” to save your settings in popup dialog.

8.4.2 X-B QC Run

X-B QC is a QC without control materials. The basic method of measuring X-

B QC is the floating mean method.
In X-B QC setup interface, “On” and “Off” is to open and close X-B QC
running. Select “On” to run the X-B QC. Sample number is to control sample
amount of one group. For example, there are 20 samples in one group, the
analyzer makes 20 times of X-B QC testing as choosing “On”.

8.4.3 X-B QC Review

There are two ways of review: QC graph review and QC list review.

QC graph review
Operator can review QC results of three parameters through graphs. Click “X-
B graph” to review it.
Dots of MCV, MCH and MCHC are drawn on the QC graph after a set of
sample testing. For example, there are 20 samples in one set, the analyzer
makes 20 times of X-B QC testing as choosing “On”. One X-B QC result is

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automatically calculated and gets corresponding QC dot. See Figure 8-11.

Figure 8-11 X-B QC Graph

There are three graphs of MCV, MCH and MCHC. The graphs updates at
once after each set of QC counting.

Click , , and to review more test results. Each dot in graph has

the corresponding date and time. The displayed date and time are subject to
the final data’s date and time within one set.

QC Graph Instruction
1. It’s a graph with times of QC count on horizontal axis and results of QC
count on vertical axis.

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2. 20 dots can be displayed on each page for each parameter. Turn

another page to see other dots.
3. The above line on the graph means Reference plus limit.
4. The below line on the graph means Reference value subtract limit.
5. The 3 values on the left side of parameter graph mean
a) upper line ——Reference + limit
b) middle line ——Reference
c) lower line ——Reference –limit
If the control dot falls in the area between upper and lower limit of the
corresponding graph, it means the dot is under control; if not, the dot is out of
control.
QC list review
Operator can review QC results of three parameters through graphs. Click
“QC list” in “X-B Graph” to enter the interface. See Figure 8-12.

Figure 8-12 X-B QC List

Click , , and to review test results. The average of a set of data is

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saved after testing. Click “Delete” to delete the selected test results. Click
“Emptied” to delete all results. Click “Export” to export all data. Click “Return”
to go back to X-B graph interface.
The reference and limit shown in this interface are the value input in editing.
The reference and limit in QC list changes according to that in editing.

8.5 X-R QC

X-R QC is a kind of the QC methods with control material. If running a blank

count, the system alarms that QC count result is invalid.
Click “X-R QC” in setup interface, see Figure 8-13.

Figure 8-13 QC Interface

Setup: enter QC edit interface

QC Graph: check QC dots
QC List: check QC data
Return: go back to setup interface

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8.5.1 X-R QC Edit

Click “Setup” to edit it. See Figure 8-14.

New: create a new set of QC
Edit: modify the edited QC information
Delete: delete the selected QC
Emptied: delete all QC
Return: go back to X-R QC interface
Click “New” to pop up the dialog box as shown in Figure 8-15.
Lot, QC material type, QC Case ID, level and valid period can be edited. Click
“OK” to save and click “Cancel” to cancel the edit.
The edited QC information can be seen in edit interface. There are at most
100 sets of QC data can be tested.
Click “Return” to go back to X-R QC interface to do QC test. The QC running
interface displays two QC test results separately and automatically calculates
mean and range after finishing the second QC count. The mean of two QC
test data is one set of data.

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Figure 8-14 X-R Setup Interface

Figure 8-15 Edit

8.5.2 X-R QC Graph

Click “QC graph” in X-R QC interface, see Figure 8-16.

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Figure 8-16 X-R QC Graph

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 “Low” and do QC test twice, the dot is within X graph
corresponding with low level. It also fits for the dots of other sets—the dot
correspond with range are within corresponding R graph.
X graph Instruction
1. It’s a graph with times of QC count on horizontal axis and results of
QC count on vertical axis.
2. For every parameter, 100 dots can be displayed.
3. For every parameter, center line indicates X (overall mean of QC
results).
4. Above line means X upper limit＝X＋A×R.
5. Below line means X lower limit＝X－A×R.
6. The 3 values on the left side of parameter graph mean
a) upper line —— X upper limit＝X＋A×R
b) middle line —— X
c) lower line —— X lower limit＝X－A×R

R graph Instruction
1. It’s a graph with times of QC count on horizontal axis and results of
QC count on vertical axis.
2. For every parameter, 100 dots can be displayed.
3. For every parameter, center line indicates R (overall mean of QC
results range).
4. Above line means R upper limit＝B×R.
5. Below line means R lower limit＝C×R.
6. The 3 values on the left side of parameter graph mean
a) upper line —— R upper limit＝B×R
b) middle line —— R
c) lower line —— R lower limit＝C×R

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If the control dot falls in the area between above and below lines, it means the
dot is under control. If not, the dot is out of control.

Click , , and to review graphs of different parameters. Click

“Return” to go back to X-R interface.

8.5.3 X-R QC List

Select one set of QC in edit interface and click “QC list” in X-R QC interface.
The displayed data is the selected QC data. See Figure 8-17.

Figure 8-17 X-R QC List

Export: export QC data

Delete: delete selected data
Emptied: delete all data
Return: go back to X-R interface

There are at most 100 pieces of data can be reviewed in QC list. Click ,

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, , , , , and to review test results.

Different from X and L-J QC, only 3 pieces of QC result can be displayed in X-
R QC List review interface. Every QC result contains mean value and range.
The first two columns on first page of the list is total mean and average range.
The list updates after two times of QC test. The data displayed in the QC list
is the average of the two times of QC count results.

8.6 X QC

X QC is a kind of the QC method with control materials. The analyzer

aspirates control materials to do QC test. Operator could do QC test for 24
parameters. Considering different needs, operator can do QC test for some of
them only. 3 QC documents of high, normal and low are provided for saving.

8.6.1 X QC Edit

Click “X QC” in setup interface, see Figure 8-18.

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Figure 8-18 X QC Interface

Setup: enter QC edit

QC Graph: check QC dots
QC List: check QC data
Return: go back to setup interface

8.6.2 X QC Edit

Click “Setup” to enter edit interface. See Figure 8-19.

New: create a new set of QC
Edit: modify the edited QC information
Delete: delete the selected QC
Emptied: delete all QC
Return: go back to X QC interface

Figure 8-19 X QC Setup

Click “New” to enter edit interface. See Figure 8-20.

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Figure 8-20 X QC Edit

Lot, QC material type, QC Case ID, level, runaway mode, reference, limit and
valid period can be edited. Click “Limit setup” to choose method. See Figure
8-21.

Figure 8-21 Limit Setup

The QC running interface displays two QC test results separately and
automatically calculates mean and range after finishing the second QC count.
The mean of two QC test data is one set of data.

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8.6.3 X QC Graph

Click “QC Graph” in X QC interface, see Figure 8-22.

Figure 8-22 X QC Graph

The operator could review 24 parameters’ result via QC graph.
Different from L-J QC, every dot on the X QC Graph indicates mean value of
two times of QC results. According to different types of quality controls, there
are low, normal and high graphs. If select “Low” to do control test twice, the
control dot corresponding to mean value presents in low graph. Other types
present in corresponding graph.
QC graph Instruction
1. It’s a graph with QC times on horizontal axis and QC results on vertical
axis.
2. For every parameter, 100 dots can be displayed.
3. Above line means Reference plus limit.
4. Below line means Reference subtract limit.
5. The 3 values on the left side of parameter graph mean.

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a) upper limit ——Reference + limit

b) middle line ——Reference
c) lower limit ——Reference - limit
If the control dot falls in the area between above and below lines, it means the
dot is under control. If not, the dot is out of control.

8.6.4 X QC Graph List

Select one set of QC in edit interface and click “QC list” in X QC interface. The
displayed data is the selected QC data. See Figure 8-23.

Figure 8-23 X QC List

Export: export QC data

Delete: delete selected data
Emptied: delete all data
Return: go back to X QC interface

There are at most 100 pieces of data can be reviewed in QC list. Click ,

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, , , , , and to review test results.

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 Chapter 9 Calibration

9.1 Overview

Analyzer is inspected and calibrated before delivery. 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, and calibration factor.
The analyzer provides three kinds of calibration modes: Standard, Blood and
Manual.

WARNING
 Only calibrators recommended by supplier can be used to accomplish the
calibration.
 Follow the use instruction to store and use calibrator.
 Check if the container is broken or cracked before using the calibrator.
 Make sure the calibrators recover to room temperature and well mixed
slowly before use.
 Make sure the calibrators are within the expiry date.
 Make sure the there is no fault prompt and precision meets the
requirement before calibration.
 Never apply to the laboratory or clinic use unless all the parameters are
calibrated accurately.

NOTE

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 Take out calibrator from refrigerator, and warm to room temperature by

rubbing.
 Shake the vial filled with calibrator up and down 30 times at least to mix
plasma and blood cells well.

9.2 Calculation Frequency

To ensure 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 more parameters’ test results offsets.
3. Component that affects the measurement results is replaced after heavy
repair.
4. Reuse after long storage.
5. The laboratory or the clinic requires.
6. The reagent has been replaced.
7. There is obviously deviation when doing quality control test.
MCV and HCT are correlative parameters. The value of one can be calculated
from the other by the analyzer. So only MCV can be calibrated by the
analyzer. Usually the manufacturer gives the reference value of MCV and
HCT at the same time.

WARNING

 All clinical specimens, control materials, calibrators have potential

infectious hazard. Operator should comply with the safe operation
provisions in laboratory and wear personal protective equipment (lab

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coats, gloves etc.) when handling these materials.

9.3 Preparation

Before calibration, inspect the analyzer as the following steps.

1. Ensure the reagents are sufficient, uncontaminated and in the shelf life.
2. Run a blank test and make sure the results are accordance with Table 9-
1.
Table 9-1 Blank Range
Parameter Range
WBC ≤0.20×10^9 /L
RBC ≤0.02×10^12 /L
HGB ≤1g /L
PLT ≤10.0×10^9 /L
3. Make sure there’s no fault prompt.
4. Access whether the precision of instrument is acceptable. Test control
material in normal level or human blood 11 times continuously. Take the
results from the second to the eleventh, and check CV in data interface.
Make sure they are accordance with Table 9-2.
Table 9-2 CV
Parameter Range CV
WBC 3.5 ×10^9/L ~15.0×10^9 /L ≤2.0%
RBC 3.00 ×10^12 /L ~6.00×10^12/L ≤1.5%
HGB 100 g/L ~180 g/L ≤1.5%
100 ×10^9 /L ~149×10^9 /L ≤6.0%
PLT
150 ×10^9 /L ~500×10^9 /L ≤4.0%
HCT / 35%~50% ≤2.0%
MCV 70 fL ~120 fL ≤1.0%
5. Test control materials in high level three times and then test control
materials in low level three times immediately. Calculate carryover by the
following formula and the result should comply with Table 9-3.

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Table 9-3 Carryover

Parameter Result
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.6%
PLT ≤1.0%

9.4 Calibration Modes

9.4.1 Manual Calibration

Click “Manual” in “Cal” interface. See Figure 9-1.

The principles of new calibration value
 Mean value=(value1+value2+value3+value4)/4
 New calibration value=(reference/mean value)×former calibration value
 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 coefficient is 103%, and the test result is 230, thus the new
calibration coefficient is
New calibration coefficient =103%×220/230
=98.52%
Input new calibration coefficient and click “Save” to save it.

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Figure 9-1 Manual Calibration

Click “Save” to save the new calibration coefficient in database.
Click “Print” to print calibration value.
Click “Export” to export data sheet.

NOTE
 The analyzer can calibrate one or all parameters of

WBC，RBC，HGB，MCV，MPV, RDW_CV, RDW_SD, PLT and PDW.

 Do remember click “Save” to save calibration value before exiting Cal

interface.

Validation of calibration coefficient

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After calibration, it’s recommended to validate the calibration coefficients as

following steps.
1. Test the calibrators three times, and check whether the results are within
the allowed range.
2. Test calibrators in High, Normal and Low level respectively three times at
least. Check whether the results are within the allowed range.
3. Analyze three normal fresh blood samples three times for each at least.
Check whether the results are within the allowed range.

NOTE
 The calibration coefficient is allowed in the range of 70%~130%. If the new
calibrator coefficient is out of the range, the critical value of the limit range
should be regarded as the new calibration coefficient. In that case,
operator should find out reasons and calibrate again.

9.4.2 Standard Calibration

Click “Standard” in “Cal” interface as Figure 9-2.

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Figure 9-2 Standard Calibration

Please calibrate according to the following procedures.
1. Input lot number of calibrator.
2. Input reference of parameters which need calibration. For those
parameters which needn’t calibration, their reference is blank.
3. Click “Test” to start calibration. The analyzer could automatically calculate
the mean value of 10 tests at most. It’s recommend to test 3 to 5 times at
least.
4. The new calibration coefficient is automatically calculated according to the
reference value of calibrators and mean.
5. Click “Save” to save new calibration coefficient, click “Print” to print the
new calibration coefficient.
6. Click “Export” to export the backup calibration coefficient data.

Validation of Calibration coefficient

After calibration, it’s recommended to validate the calibration coefficients as

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following steps.
1. Test the calibrators three times, and check whether the results are within
the allowed range.
2. Test calibrators in High, Normal and Low level respectively three times at
least. Check whether the results are within the allowed range.
3. Analyze three normal fresh blood samples three times for each at least.
Check whether the results are within the allowed range.
Input reference in standard mode. Put the prepared calibrator under the
sample probe and press Count button on the front housing. The test results
are displayed in box of measured value. The first calibration test result display
in value 1, and so on. The analyzer recalculates the new calibration value
based on the reference and the measured mean after each counting.
The principles of new calibration value

 New calibration value=(reference/mean value)×former calibration

value
 If the new calibration value<70%, consider it equals to 70%; if the
new calibration value>130%, consider it equals to 130%

9.4.3 Blood Calibration

Click “Blood” in “Cal” interface. See Figure 9-3.

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Figure 9-3 Blood Calibration

Calibrate the analyzer as follows.
1. Prepare 5 normal whole blood samples and test each of them at least 5
times by other types of analyzer. Calculate the mean and input it into
reference box.
2. Select Case ID 1 on the right corner and press Count button on the front
housing to make at most 10 times of counting and get mean value.
Please test it no less than 5 times. Then Select Case ID 2 on the right
corner and press Count button on the front housing to make at most 10
times of counting and get mean value. Please test it no less than 5
times, and so on.
3. The system adds the measured values and calculates the average of
parameters. System automatically calculates new calibration coefficient
according to reference, mean value and calibration coefficient.
4. Click “Save” to save new calibration coefficient, and click “Print” to print
it.
5. Click “Export” to export the backup calibration coefficient data

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 New calibration value=(reference/mean value)×former calibration value

 If the new calibration value<70%, consider it equals to 70%; if the new
calibration value>130%, consider it equals to 130%

NOTE
 Please remember click “Save” to save counting results before exit.

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 Chapter 10 Service

10.1 Overview

Routine care and regular maintenance are essential for instrument to ensure
its accuracy, keep in good condition for a long time, increase its service life
and minimize system problems. Procedures and instruction for preventive
maintenance are described in this chapter. Contact our after-sale service
department for more information.
According to different requirements, preventive maintenance is divided into
daily maintenance, weekly maintenance, monthly maintenance and specific
maintenance base on actual situation.

WARNING

 All components’ surface may be potentially infectious. Safety protective

measures should be taken to avoid infection, electric shock or burn. Wear

gloves for cleaning and maintenance. Clean hands with disinfectant after
work.

10.2 Routine Maintenance

10.2.1 Daily Maintenance

1. Auto Clean
Auto cleaning program makes you needn’t bother about daily maintenance.
Based on the number of samples, operator set time for auto clean. Please
make a blank test every day after boot. Choose “On” in “Auto blank”. For the
users with plenty of samples to be tested, it’s suggested to turn on “Soak and
exit” and “Auto soak” .Times of “Auto soak” can be chosen. See Figure 10-1.

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Figure 10-1 Maint. Set

2. Shutoff
To get correct results, it’s necessary to clean counting chambers and rinse the
fluid system to prevent measurement errors caused by residues. Shutoff
program should be performed when the analyzer tests more than 500
specimens or after work everyday. 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.

10.2.2 Weekly Maintenance

Surface Maintenance
Clear the smudge on the surface, especially the blood around the sample
probe to prevent protein deposition and mildewing. Wipe the surface with
cleaning cloths with neutral detergent.

NOTE
 Never use corrosive acids, alkali or volatile organic solvent (such as
acetone, aether and chloroforms) to wipe the surface of the analyzer, but
only use neutral detergent.

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10.2.3 Monthly Maintenance

1. Check and Clean Reagent Syringes

The reagent syringes need to be cleaned regularly to prevent reagent
deposition, leakage and improper operation. Syringes should be cleaned one
by one in order to ensure all of them can be put back.
Materials Requirements
1) A large container filled with approximately 500 mL deionized water
2) Clean and soft cloth
3) Small containers used to refill the clean syringes
4) Personal protective measures
Clean Procedures
1) Empty the fluid system.
2) Open the front housing and right door to find the syringe.
3) Pull the syringe out from the pluggable bracket.
4) Aspirate the deionized water into the syringe till full. Pull the piston until it
is removed from the syringe tube.
5) Rinse the syringe piston and tube thoroughly with deinoized water.
Replace the seal ring if it gets worn.
6) Carefully reinsert the piston into the wet syringe tube.
7) When the syringe has been reinstalled, observe and run several times of
blank count. The piston should move smoothly up and down and the
syringe should not leak.

NOTE
 Do not push or pull the piston when the syringe is dry, as it may damage
the piston. Avoid touching the piston because oil from the fingers may
cause it move erratically.

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2. Maintenance of mechanical parts

It mainly aims at maintenance of mechanical parts, including lubricating
motor shaft, X and Y guide rod of sampling device etc. See Figure 10-2.

Figure 10-2 Maintenance of Mechanical Parts

NOTE
 To make sure it’s not in running status, please turn off the instrument
before performing monthly maintenance.
 Only trained personnel can open the front housing of instrument and clear
X, Y guide rod of sampling device.

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10.3 Maintenance procedure

Click “Maintenance” in Setup interface, see Figure 10-3.

Figure 10-3 Maintenance Interface

Function and operation of them are as below.

10.3.1 Change Lyse

Please change lyse in following conditions.

 There are bubbles in the lyse tubing.
 Lyse in tubing is contaminated.
 Lyse is used up.

Operation Procedures
1. Click “Change Lyse” in “Maint” interface.
2. The analyzer starts to execute it. All buttons turn gray.

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3. The operation is completed and buttons return to normal.

10.3.2 Change Diluent

Please change diluent in following conditions.

 There are bubbles in the diluent tubing.
 The diluent in tubing is contaminated.
 Diluent is used up.

Operation Procedures
1. Select Change Diluent in “Maint” interface.
2. The analyzer starts to execute it. All buttons turn gray.
3. The operation is completed and buttons return to normal.

10.3.3 Change Detergent

Please change detergent in following conditions.

 There are bubbles in the detergent tubing.
 The detergent in tubing is contaminated.
 Detergent is used up.

Operation Procedures
1. Select “Change Detergent” in “Maint” interface.
2. The analyzer starts to execute it. All buttons turn gray.
3. The operation is completed and buttons return to normal.

WARNING

 All clinical specimens, control materials, calibrators and waste have

potential infectious hazard. Operator should comply with the safe
operation provisions in laboratory and wear personal protective equipment
(lab coats, gloves, safety glasses, etc.) when handling these materials.
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NOTE
 Keep the reagent still for a while to let it stable.
 After replacement of diluent, detergent, sheath or lyse, perform blank
count to ensure the blank values are in the acceptable range.

10.3.4 Change Sheath

Please change sheath in following conditions.

 Three are bubbles in the sheath flow regulator.
 The sheath in tubing is contaminated.
 Sheath is used up.

Operation Procedures
1. Click “Change Sheath” in “Maint” interface.
2. The analyzer starts to execute it . All buttons turn gray.
3. The operation is completed and buttons return to normal.

10.3.5 Cauterize Aperture

Cauterize both sides of the ruby aperture with a high voltage to clear protein
and dust adhering or blocking on the aperture. It prevents and eliminates
clogging. The procedures are as follows.
1. Click “Cauterize Aperture” in the “Maint” interface.
2. The analyzer starts to execute it and all buttons turn gray.
3. The operation is completed and buttons return to normal.

10.3.6 Flush Aperture

Together with “Cauterize Aperture”, “Flush Aperture” prevents and eliminates

blockage. The procedures are as follows.
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1. Click “Flush Aperture” in “Maint” interface.

2. The analyzer starts to perform the function and all buttons turn gray.
3. The operation is completed and buttons return to normal.

10.3.7 Soak Impedance Transducer

WARNING

 All clinical specimens, control materials, calibrators have potential

infectious hazard. Operator should comply with the safe operation
provisions in laboratory and wear personal protective equipment (lab
coats, gloves, safety glasses, etc.) when handling these materials.

Soak impedance transducer with probe cleaner. The procedures are as

follows.
1. Click “Soak impedance transducer” in the “Maint” interface.
2. The analyzer starts to perform the function and all buttons turn gray.
3. The operation is completed and buttons return to normal.

If the ruby aperture is clogged severely, please select “Soak Impedance

Transducer” in “Maint.” interface, and then put the probe detergent under the
sample probe. The analyzer will automatically aspirate the probe detergent
into the sample cup to soak the ruby aperture.

NOTE
 Probe cleaner is corrosive, so operator should wear lab coats, gloves, and
follow required laboratory or clinical procedures.

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10.3.8 Prepare Shipping

Perform this function before shipping or long term storage. The procedures
are as follows.
1. Take out the diluent inlet tubing connecting with the “DELUENT” on the
rear panel.
2. Take out the lyse inlet tubing connecting with the “LYSE” on the rear
panel.
3. Take out the detergent inlet tubing connecting with the “DETERGENT”
on the rear panel.
4. Take out the sheath inlet tubing connecting with the “SHEATH” on the
rear panel.
5. Unscrew the cap of reagent containers and keep the tubes well.
6. Keep the remaining reagents in their containers and store them
according to instructions. Operator should establish and confirm to the
Storage measures should be established and maintained to prevent
reagent from deteriorating, misusing or accidental ingestion. The
reagent should be away from temperature extremes.
7. Click “Prepare Shipping” in “Maint” interface, click “OK” in popup dialog
box.
8. The analyzer starts to perform the function.
9. The operation is completed and back to the “Maint” interface.

10.3.9 Others

Empty transducer: empty liquid in the transducers

Rinse impedance channel: clean impedance channel
Rinse optics channel: clean optics channel
Soak sheath flow regulator: soak the sheath flow regulator with probe
detergent.

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Chapter 10 Service

10.4 Components Maintenance

Time and required tools for 5160 components maintenance

Components Maintenance Time Required Tools
Syringe module After 6000 sample tests Grease, brush, cloth
Sample injection After 6000 sample tests Grease, brush, cloth
mechanism
Transducer After 6000 sample tests Probe detergent,
cross screwdriver
Sheath flow regulator After 6000 sample tests Probe detergent
Waste filter for WOC After 6000 sample tests Probe detergent,
cup cross screwdriver
Waste filter for WIC After 6000 sample tests Probe detergent,
cup cross screwdriver
Waste filter for RBC After 6000 sample tests Probe detergent,
cup cross screwdriver

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Chapter 10 Service

10.5 Components Replacement

Time and required tools for 5160 components replacement

Components Replacement Time Required Tools
Probe wiper After 60000 sample tests Tweezers,
cross screwdriver
Waste filter for WOC After 60000 sample tests Tweezers,
cup cross screwdriver
Waste filter for WIC cup After 60000 sample tests Tweezers,
cross screwdriver
Waste filter for RBC cup After 60000 sample tests Tweezers,
cross screwdriver
Syringe seal ring After 100000 sample Tweezers,
tests cross screwdriver

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 Chapter 11 Troubleshooting

11.1 Overview

This chapter gives instructions for fault identifying and troubleshooting. If the
malfunction is not solved according to the guidance, or if more detail
information is needed, please contact our after-sale service department.

NOTE
 This manual is not service manual. It only provides the measures when
there are failure warnings.

WARNING

 Potential biohazard. Maintain, repair and troubleshoot according to the

established safe operation procedures.

11.2 Troubleshooting Guidance

Troubleshooting guidance is used to assist operator to identify and resolve

analyzer problems. Also it offers you method of obtaining technical assistance
from our after-sale service department. Excellent troubleshooting skills are
derived from deep understanding of the instrument and rich operation
experience. Please follow these three steps to do troubleshooting.
(1) Problem identification
(2) Problem classification
(3) Troubleshooting
Step1 Problem Identification
135
Chapter 11 Troubleshooting

Operator can not only identify what is wrong, but also know what it should be
in normal circumstance. Troubleshooting depends on proper problem
identification.
Step2 Problem Classification
Problems are divided into three types.
(1) Hardware-related failures
(2)Software-related failures
(3)Failures related to sample analysis
Hardware and software problems can only be corrected by a supplier
authorized engineer. The operator can correct sample measurement
problems
with assistance from supplier engineers.

Step3 Troubleshooting
Engineers take appropriate action to deal with the problem. Solve problems
by operator himself or with supplier engineer’s assistance can save you much
time.

11.3 Obtaining Technical Assistance

Please contact our after-sale service department or local agency for technical
assistance. Offer us detailed problem description and related information,
specific as follow:
1. The analyzer model
2. Serial number and version number
3. Detailed problem description and operating environment, including status
and operation.
4. The lot number of the reagents (sheath, diluent, lyse, etc.)
5. Related data and report of the problem
Common problems and handling methods are given in this Chapter. Operator
can identify the cause according to the alarm prompt and operate according to
Troubleshooting Guidance.

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Chapter 11 Troubleshooting

11.4 Troubleshooting

Common problems and corrective actions are listed as follows. If the problems
cannot be corrected, or technical assistance is needed, please contact our
after-sale service department.
Fault Probable Cause Corrective Action
1.Motor signal line poor
contact.
1.Lubricate motor guide rod.
2.Limit optocoupler.
2.Click "Fault clearing" to clear faults
3.Motor fault.
MA motor fault automatically.
4.Motor drive circuit fault.
3.If the fault still exist, please contact our
5.Motor power fault.
after-sale service department.
6.Motor guide rod is not
lubricating enough.
1.Motor signal line poor
contact.
1.Lubricate motor guide rod.
2.Limit optocoupler.
2.Click "Fault clearing" to clear faults
3.Motor fault.
MB motor fault automatically.
4.Motor drive circuit fault.
3.If the fault still exist, please contact our
5.Motor power fault.
after-sale service department.
6.Motor guide rod is not
lubricating enough.
1.Motor signal line poor
contact.
1.Lubricate motor guide rod.
2.Limit optocoupler.
2.Click "Fault clearing" to clear faults
3.Motor fault.
MC motor fault automatically.
4.Motor drive circuit fault.
3.If the fault still exist, please contact our
5.Motor power fault.
after-sale service department.
6.Motor guide rod is not
lubricating enough.

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Chapter 11 Troubleshooting

1.Motor signal line poor

contact.
1.Lubricate motor guide rod.
2.Limit optocoupler.
2.Click "Fault clearing" to clear faults
3.Motor fault.
MD motor fault automatically.
4.Motor drive circuit fault.
3.If the fault still exist, please contact our
5.Motor power fault.
after-sale service department.
6.Motor guide rod is not
lubricating enough.
1.Motor signal line poor
contact.
1.Lubricate motor guide rod.
2.Limit optocoupler.
2.Click "Fault clearing" to clear faults
3.Motor fault.
MG motor fault automatically.
4.Motor drive circuit fault.
3.If the fault still exist, please contact our
5.Motor power fault.
after-sale service department.
6.Motor guide rod is not
lubricating enough.
1.Motor signal line poor
contact.
1.Lubricate motor guide rod.
2.Limit optocoupler.
2.Click "Fault clearing" to clear faults
3.Motor fault.
MH motor fault automatically.
4.Motor drive circuit fault.
3.If the fault still exist, please contact our
5.Motor power fault.
after-sale service department.
6.Motor guide rod is not
lubricating enough.
1.Click "Fault clearing" to clear faults
automatically.
Expired diluent Diluent is expired.
2.If the fault still exist, please contact our
after-sale service department.
1.Click "Fault clearing" to clear faults
automatically.
Expired sheath Sheath is expired.
2.If the fault still exist, please contact our
after-sale service department.

138
Chapter 11 Troubleshooting

1.Click "Fault clearing" to clear faults

automatically.
Expired lyse Lyse is expired.
2.If the fault still exist, please contact our
after-sale service department.
1.Click "Fault clearing" to clear faults
Expired automatically.
Detergent is expired.
detergent 2.If the fault still exist, please contact our
after-sale service department.
1.Check if the diluent is run out.
1.Diluent is run out. 2.Tighten the tube joint.
2.Tube joint leakage or 3.Neaten and unchoke tubes.
Diluent empty bubble 4.Click "Fault clearing" to clear faults
3.Connecting tubes are automatically.
bent or clogged. 5.If the fault still exist, please contact our
after-sale service department.
1.Check if the sheath is run out.
1.Sheath is run out. 2.Tighten the tube joint.
2.Tube joint leakage or 3.Neaten and unchoke tubes.
Sheath empty bubble. 4.Click "Fault clearing" to clear faults
3.Connecting tubes are automatically.
bent or clogged. 5.If the fault still exist, please contact our
after-sale service department.
1.Check if the lyse is run out.
1.Lyse is run out. 2.Tighten the tube joint.
2.Tube joint leakage or 3.Neaten and unchoke tubes.
Lyse empty bubble. 4.Click "Fault clearing" to clear faults
3.Connecting tubes are automatically.
bent or clogged. 5.If the fault still exist, please contact our
after-sale service department.

1.Detergent is run out. 1.Check if the detergent is run out.

Detergent
2.Tube joint leakage or 2.Tighten the tube joint.
empty
bubble. 3.Neaten and unchoke tubes.

139
Chapter 11 Troubleshooting

4.Click "Fault clearing" to clear faults

3.Connecting tubes are automatically.
bent or clogged. 5.If the fault still exist, please contact our
after-sale service department.。
1.Click "Fault clearing" to clear faults
1.Aperture is clogged.
automatically.
2.Tubes are bent.
2. Click “Setting”, and perform “Soak
WBC Clog 3.Reagent replacement
impedance transducer” in Maint.”interface.
error.
3.If the fault still exist, please contact our
4.Solenoid valve problem.
after-sale service department.
1.Insufficient liquid in
sample cup front chamber/
1.Click "Fault clearing" to clear faults
after chamber.
automatically.
WBC Bubble 2.Tubes joint is leaky.
2.If the fault still exist, please contact our
3.Reagent replacement
after-sale service department.
error.
4.Solenoid valve problem.
1.Click "Fault clearing" to clear faults
1.Aperture is clogged.
automatically.
2.Tubes are bent.
2.Click “Setting”, and perform “Soak
RBC Clog 3.Reagent replacement
impedance transducer” in Maint.”interface.
error.
3.If the fault still exist, please contact our
4.Solenoid valve problem.
after-sale service department.
1.Insufficient liquid in
sample cup front chamber/
1.Click "Fault clearing" to clear faults
after chamber.
automatically.
RBC Bubble 2.Tubes joint is leaky.
2.If the fault still exist, please contact our
3.Reagent replacement
after-sale service department.
error.
4.Solenoid valve problem.
Low HGB Blank HGB blank voltage is low. 1.Click "Fault clearing" to clear faults
voltage automatically.

140
Chapter 11 Troubleshooting

2.If the fault still exist, please contact our

after-sale service department.
1.Click "Fault clearing" to clear faults
High HGB automatically.
HGB blank voltage is high.
Blank voltage 2.If the fault still exist, please contact our
after-sale service department.
1.Click "Fault clearing" to clear faults
1.Vacuum tank is leaky. automatically.
Low vacuum
2.Tubes are leaky. 2.If the fault still exist, please contact our
after-sale service department.
1.Click "Fault clearing" to clear faults
Optical
1.Pressure tank is leaky. automatically.
pressure
2.Tubes are leaky. 2.If the fault still exist, please contact our
Abnormity
after-sale service department.
1.Check if indoor temperature is too low.
2.If indoor temperature is normal but alarm
Low
Temperature is below 15°. still exist, please restart the instrument.
temperature
3.If the fault still exist, please contact our
after-sale service department.
1.Check if indoor temperature is too high.
2.If indoor temperature is normal but alarm
High
Temperature is over 35°. still exist, please restart the instrument.
temperature
3.If the fault still exist, please contact our
after-sale service department.
1.Empty waste container or replace a new
1.Waste container is full. one.
Waste full
2.Waste sensor is in fault. 2.If the fault still exist, please contact our
after-sale department.
1.Click "Fault clearing" to clear faults
Optical Optical communication is
automatically.
communication abnormal. Cannot receive
2.If the fault still exist, please contact our
error and send data.
after-sale service department.
Printer no 1.Connecting line. 1.Check the if the printer power cord and USB

141
Chapter 11 Troubleshooting

cable contacts well. Re-plug USB cable and

power cord, and restart the printer.
responds 2.Printer error.
2.If the fault still exist, please contact our
after-sale service department.

142
 Appendix A Specification

A.1 Product classification

According to the CE classification, the analyzer is an In Vitro Diagnostic

device.

A.2 Reagents

Diluent, lyse, detergent and sheath. Please refer to A.7 Reagent Specification
for details.

A.3 Model of Blood Sampler

Apply to whole blood mode: Ф12～15×75mm (no cover size)

Apply to diluent and peripheral blood test: Ф11×40mm (1.5m centrifuge tube)
and 0.5ml Centrifuge tube
Apply to peripheral blood test: Ф10.7×42mm (no cover size), 0.5ml closed
anticoagulant tube, can open the cover and test. The recommendation tube:
BD 0.5ml closed anticoagulant tube, SN: 365974

A.4 Technical Specifications

A.4.1 Parameters

Abbreviation Full Name Unit

WBC White Blood Cell Count 10^9/L
LYM% Lymphocyte Percent %
MON% Monocyte Percent %
NEU% Neutrophil Percent %
EOS% Eosinophil Percent %
BASO% Basophil Percent %
143
Appendix A Specifications

LYM# Lymphocyte Count 10^9/L

MON# Monocyte Count 10^9/L
NEU# Neutrophil Granulocyte Count 10^9/L
EOS# Eosinophil Granulocyte Count 10^9/L
BASO# Basophil Granulocyte Count 10^9/L
RBC Red Blood Cell Count 10^12/L
HGB Hemoglobin g/L
RETIC-ABS Reticulocyte absolute value 10^12/L
RETIC Reticulocyt %
IRF Immature Reticulocyte Fractio %
Hematocrit (relative volume of
HCT %
erythrocytes)
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular Hemoglobin pg
Mean Corpuscular Hemoglobin
MCHC g/L
Concentration
Red Blood Cell Distribution Width repeat
RDW_CV %
precision
RDW_SD Red Blood Cell Distribution Width STDEV fL
PLT Platelet Count 10^9/L
MPV Mean Platelet Volume fL
PDW Platelet Distribution Width fL
PCT Plateletcrit %
P_LCR Large Platelet Percent %
P_LCC Large Platelet Count 10∧9/L
ALY% Abnormal Lymphocyte Percent %
ALY# Abnormal Lymphocyte Count 10∧9/L
LIC% Large Immature Cell Percent %
LIC# Large Immature Cell Count 10∧9/L
NRBC% Nucleated Red Blood Cell Percent %
NRBC# Nucleated Red Blood Cell Count 10∧9/L

144
Appendix A Specifications

A.4.2 Test Speed

60 / hour

A.4.3 QC Modes

L-J QC, X-B QC, X-R QC and X QC

A.4.4 Calibration Modes

Standard Calibration
Blood Calibration
Manual Calibration

A.4.5 Parameters Measurement and Calculation

(1) WBC total amount and 5Diff using laser method

(2) Colorimetric method for the determination of HGB
(3) Electrical impedance method for RBC and PLT
(4) MCV, HCT, RDW_CV, RDW_SD, MPV, PDW, MCH, MCHC and PCT are
obtained directly by calculating the stored data.

A.4.6 Input/output Devices

(1) Keyboard (optional)

(2) External barcode scanner (optional)
(3) External printer (optional)

WARNING
Be sure to use the specified devices only.

145
Appendix A Specifications

A.5 Physical Specifications

A.5.1 Power Requirements

Optimum Work Work Voltage Range Frequency

Voltage
AC 220V AC 100V-240V 50/60 Hz

A.5.2 Fuse

WARNING
Please use the specified specifications of fuse.

Fuse specifications: T3.15AL 250V

A.5.3 Electromagnetic compatibility

It is advisable to check the electromagnetic environment before using the

analyzer. Do not use this equipment near strong radiation sources, such as
unshielded RF sources; otherwise it may interfere with the normal operation of
the analyzer.

A.5.4 Sound pressure

Maximum sound pressure: 65 dBA

CAUTION
 Be sure to use the specified devices only.

146
Appendix A Specifications

A.5.5 Environment Requirements

(1) Temperature: 15°C~35°C

(2) Relative Humidity: 30~80％
(3) Barometric Pressure: 60kPa~106kPa

A.5.6 Storage Environment

(1) Temperature: -10°C~55°C

(2) Relative Humidity: ≤95%
(3) Barometric Pressure: 50kPa~106kPa

A.5.7 Size and Weight

(1) Length: about 490mm

(2) Height: about 459mm
(3) Width: about 332mm
(4) Weight: about 35Kg

A.5.8 Contraindications

NO

A.5.9 Overvoltage Category and Pollution Level

Overvoltage category: Class II

Pollution level: Level 2

A.5.10 Waste

Dispose the waste according to the national or local standards.

147
Appendix A Specifications

A.5.11 Minimum Sample Volume

Whole Blood Sampling Mode 20µL

Diluent Sampling Mode 20µL

A.5.12 Dilution Ratio

(1) WBC: approximately 1:251

(2) RBC/PLT approximately 1:24347

A.5.13 Diameter

(1) WBC: 100μm

(2) RBC/PLT: 68μm

A.5.14 HGB measurement

(1) Measure HGB in WBC/HGB cup

(2) The illuminant is led, and the wavelength is 540nm.

A.6 Performance Index

A.6.1 Precision

Acceptable Limits
Parameter Precision Range
(CV）
WBC 3.5×10∧9/L ~15.0×10∧9/L ≤2.0%
RBC 3.00×10∧12/L ~6.00×10∧12/L ≤1.5%
HGB 100 g/L ~180 g/L ≤1.5%
PLT 100×10∧9/L ~149×10∧9/L ≤5.0%
150×10∧9/L ~500×10∧9/L ≤4.0%
HCT / 35%~50%（HCT）/ ≤2.0%
MCV 70fL ~120fL（MCV） ≤1.0%

148
Appendix A Specifications

A.6.2 Linearity

Parameter Linearity Range Acceptable correlation

Limits coefficent r

0 ×109 /L～10.0×109 /L ±0.5 ×109 /L

WBC ≥0.990
10.1 ×109 /L～100.0×109 /L ±5%
0.10 ×1012 /L～1.00×1012 /L ±0.05 ×1012 /L
RBC ≥0.990
1.01 ×1012 /L～8.00×1012 /L ±5%
0 g/L～70 g/L ±2 g/L
HGB ≥0.990
71 g/L～250 g/L ±2%
0×109 /L1～100×109 /L ±10 ×109 /L
PLT ≥0.990
101 ×109 /L～1000×109 /L ±8%

A.6.3 Accuracy of WBC Classification

Neutrophils, lymphocytes, monocytes, eosinophils and basophils were

measured within the allowable range (99% confidence interval).
Note:When the reference result equals to 0 and the result of the analyzer
≤1.0%,the conclusion is PASS.

A.6.4 Carryover

Parameter Measurement Result

WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.6%
PLT ≤1.0%

A.6.5 Blank Count

Parameter Measured Value Range

WBC ≤0.20×10∧9 /L
RBC ≤0.02×10∧12 /L

149
Appendix A Specifications

HGB ≤1g/L
PLT ≤10.0×10∧9 /L

A.6.6 Indication error

Parameter Indication error

WBC ≤±10.0%
RBC ≤±6.0%
HGB ≤±7.0%
PLT ≤±15.0%

A.6.7 Accuracy

Parameter Result Range Acceptable Deviation

Range

WBC 3.5×10^9/L ～ 9.5×10^9/L ≤±8.0%

RBC 3.8×10^12/L ～ 5.8×10^12/L ≤±4.0%

HGB 115g/L ～ 175g/L ≤±4.0%

PLT 125×10^9/L ～ 350×10^9/L ≤±10.0%

35% ～ 50% （ HCT ） / ≤±5.0%(HCT)/

HCT/MCV
80fL～100fL（MCV） ≤±3.0%(MCV)

A.6.8 Display Range of Main Parameters

Parameter Display Range

WBC 0～500.00×109/L
RBC 0～99.00×1012/L
HGB 0～300g/L
HCT 0%～99%
PLT 0～9999×109/L

150
 Appendix A Specifications

A.7 Reagent Specifications

Name Specification
Diluent 20L/10L
Detergent 20L/10L
Sheath 20L/10L
Lyse 500mL/1L
Probe cleaner 100mL

CAUTION
 Do not pour the remaining reagent in it when replacing reagent, otherwise
it will lead to cross contamination of the reagents.

A.8 Parameters Alert Messages

Suspicious Suspicious
Parameter Alarm Interpretation
parameter tag group tag
WBC
NWBC
Shown in blue and marked WBC increased
FWBC
WBC with “L” if it’s lower than WBC Switch to RRBC
lower limit NRBC
mode and test again
RRBC as RRBC? alarms
The same as WBC DFLT BAND Neutrophil reduction
Immature
NEU (NLMEB) IG
granulocytes
LYM BLAST
Neutrophils
MON VARLYM increased

151
 Appendix A Specifications

Lymphatic reduction
Increased lymphoid
cells
EOS Increased

BASO mononuclear cells

Addicted to
eosinophil
Basophils increased

LRI Thrombocytopenia
MPV disabled
PLT URI PLT enlargement
The same as WBC (not shown or
MPV LURI Erythrocyte PLT
cannot print)
PLTR Red blood cell PLT

152
 Appendix B External communication protocol

B.1 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.2 Information Grammar

B.2.1 Delimiter

| --- Fields Delimiter

^ ---Component Delimiter
& ---Subcomponent Delimiter
~ ---Repeat Delimiter
\ --- Escape Character

B.2.2 Data Type

CX extended composite id whith check digit

CE code element
CM composite

153
Appendix B External Communication Protocol

CQ composite quantity with units

DR datetime 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
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

B.2.3 Field Meaning

1、There is a message header at the beginning of each message. It is MSH

field.
The meaning of MSH is shown as below:

154
Appendix B External Communication Protocol

N Field Data L Explanation

o Type e
. n
gt
h
1 Field mark ST 1 Separator
2 Encoding chars ST 4 Separator listing
Sending end
3 Sending Application EI 180
applications
Sending end
4 Sending Facility EI 180
facility
Receiving end
5 Receiving Application EI 180
applications
Receiving end
6 Receiving Facility EI 180
facility
Current message
7 Date Time Message TS 26 event, system
time
8 Security ST 40 Security
9 Message Type CM 7 Message Type
Message control
ID is used to
distinguish
10 Message Control ID ST 20
different
messages. See
the table below.
Dispose of ID P
11 Processing ID PT 3
Product
HL7 version is
12 Version ID VID 60
2.3.1
Application
13 Acknowledgment IS 1 Set null
Type

155
Appendix B External Communication Protocol

14 Retain
15 Retain
16 Retain
17 Retain
Encoding is
18 Encoder ST
UNICODE

M Description
S
H-
10
0001 Analyzer transmits results automatically.
1001 LIS responses, analyzer transmits results automatically.

Example:
MSH|^~\&|supplier|analyzer|LIS|PC|20100930100436||ORU^R01|0001|P|
2.3.1|1|||||UNICODE

2、PID--- Definition of patients' data field

N Field Data Le Explanation
o Type ng
. th
Identify different
1 Set ID PID SI 4 fields, fill with 1
generally.
Patient ID.,
2 Patient ID EI 20 hospital No., set
null
Indicate batch
3 Patient Identifier List CX 20 number when
QC
4 Alternate Patient ID CX 20 Bed No.

156
Appendix B External Communication Protocol

5 Patient Name XPN 48 Name

Mother’s Maiden Mother’s Maiden
6 XPN 48
Name Name, set null
Birthday；
7 Date/Time of Birth TS 26 Indicate validity
when QC
8 Sex IS 1 Male or female
Retain patient
9 Patient Alias XPN 48
alias
10 Race CE 80 Retain race
Retain patient
11 Patient Address XAD 106
address
Retain county
12 County Code IS 4
code
Retain phone
13 Phone Number XTN 40
No.
Retain office
13 Phone Number Bus XTN 40
phone No.
Retain mother
14 Primary Language CE 60
tongue
Retain Marital
15 Marital Status CE 80
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、PV1---Definition of patient visiting record field

N Field Data L Explanation

o Type e

157
Appendix B External Communication Protocol

. n
gt
h
1 Set ID PV1 SI 4 Identify different fields,
fill with 1 generally.
2 Patient Class IS 1 Patient category
3 Assigned Patient PL 80 Be used to indicate
Location patient department
Example: PV1|1Clinic| Surgery |

4、OBR--- Definition of Doctor's Advice

N Field Data Le Explanation
o Type n
. gt
h
1 Identify different
Set ID OBR SI 4 fields, fill with 1
generally.
2 Placer Order Number EI 22 Serial number
3 Assigned Patient
EI 22 Sample number
Location
4 Universal service
Universal Service ID CE 200
ID
5 Priority ID 2 Priority set null
6 Requested Date Time TS 26 Application time
7 Inspection
Observation Date
TS 26 starting time, set
time
null
8 Observation Date Inspection end
TS 26
Time end time
9 Specimen
Collection Volume CQ 20 collection
capacity, set null

158
Appendix B External Communication Protocol

10 Collector Identifier XCN 60 Sender name

11 Sample handling
SPE Action Code ID 1
code, set null
12 Danger code
Danger Code CE 60
alarm
13 "Diagnosis" ^
"Remark", each
Relevant Clinical Info ST 200 length should not
be more than
100 bytes
14 SPE Received Date Sample receiving
TS 26
Time time
15 Sample
SPE Source CM 300 classification,
blood, urine etc.
16 Ordering Provider XCN 120 Inspector name
17 Order Callback Phone Callback phone,
XTN 40
Number set null
18 Sender field 1,
Placer Field1 ST 60 Inspection
department
19 Placer Field2 ST 60 Set null
20 Operator field 1,
Filler Field1 ST 60
set null
....... The rest part is not
Set null
needed to be filled.
28 Result Copies to XCN 60 Verifier

Example：
OBR|1|1010051|000001|supplier^UT-analyzer||20101010093000||
20101010093500||sender||| diagnosis^remark||BLD|Inspector||||||||||||verifier|

159
Appendix B External Communication Protocol

5、OBX
N Field Data Le Explanation
o Type n
. gt
h
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
3 Observation Identifier CE 590
identifier 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
7 References Range ST 90 big, QC means
reference value
and deviation.
H,L and N
indicate high, low
8 Abnormal Flags ID 5
and normal value
respectively.
Probability, set
9 Probability ID 5
null
C indicates WBC
and RBC clog, B
Nature of Abnormal
10 ID 2 indicates bubble,
Test
when normal, set
null

160
Appendix B External Communication Protocol

Observe results,
11 Observe Status ID 1 take F for final
result.
The time for
12 Date Last Observe TS 26 observing 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||

6、MSA
N Field Data L Explanation
o Type e
. n
gt
h
Confirmation
code: AA is for
Acknowledgment
1 ID 2 receiving, AE for
Code
error and AR for
refusing.
2 Message Control ID 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

161
Appendix B External Communication Protocol

MMSA-6 is used to indicate different errors, see the table below.

MSA-1 MSA-6 MSA-3 False Description
AA Receive
0 Message accepted
successfully
AE The fields order in
message is not
101 Segment sequence error correct, or the
necessary fields
are lost.
Necessary fields of
102 Required field missing a paragraph are
lost.
Data type of fields
is false. For
103 Data type error example, digital is
changed into
character.
Key identifier is not
104 Key not found
found
105 Resend Resend data
AR Unsupported message Unsupported
201
type message type
Unsupported event
202 Unsupported event code
code
Unsupported processing Unsupported
203
id processing ID
Unsupported
204 Unsupported version id
version ID
205 Unknown key identifier Unknown key
identifier，For
example, transmit
an inexistent
patient information.

162
Appendix B External Communication Protocol

Duplicate key
206 Duplicate key identifier
identifier
Affairs in
application storage
Application record level can't be
207
locked carried out. For
example, database
is locked
Other errors in
208 Application internal error unknown
application.
Application is not
209 Application unready
ready

7、ERR
N Field Data Le Explanation
o Type ng
. th
1 Error Code and CM 80 Code and position
Location error

ERR-1
Assem Assem Assem Explanation
bly 1 bly 2 bly 3
001 Record Test The test tube record has
already exist tube No. already existed.
002 Lis Received Lis receiving error,
Test
Failed resending data is
tube No.
required.
003 Read REQ Test Fail to read request
error tube No. form.
004 Read Bar Test Analyzer fails to read
Code Error tube test tube number.

163
Appendix B External Communication Protocol

rack No.

164
Appendix B External Communication Protocol

8、QRD
N Field Data L Explanation
o Type e
. n
gt
h
1 Query Date/Time TS 26 Query time
2 D （display
Query Format Code ID 1
format）
3 Query Priority ID 1 I（Immediate）
4 Distinguish
different
queries ,accumul
Query ID ST 10
ate with query
times. The initial
value is 1.
5 Deferred Response
ID 1 Set null
Type
6 Deferred Response
TS 26 Set null
Date/Time
7 Quantity Limited
CQ 10 RD（Records）
Request
8 Take as a test
Who Subject Filter XCN 60 tube code \
sample number.
9 What Subject Filter CE 60 OTH
10 What Department
CE 60 Set null
Data Code
11 What Data Code
CM 20 Set null
Value Qual.
12 Query Results Level ID 1

9、QRF

165
Appendix B External Communication Protocol

N Field Data L Explanation

o Type e
. n
gt
h
1 Where Subject Filter ST 20 Take analyzer
2 When Data Start
TS 26 Application time
Date/Time
3 When Data End
TS 26 Deadline
Date/Time
4 What User Qualifier ST 60 Set null
5 Other QRY Subject
ST 60 Set null
Filter
6 RCT(Specimen
receipt date/time,
Which Date/Time receipt of
ID 12
Qualifier specimen in
filling ancillary
(Lab))
7 Which Date/Time
ID 12 ANY(Any status)
Status Qualifier
8 Date/Time Selection ALL(All values
ID 12
Qualifier within the range)
9 When
Quantity/Timing TQ 60 Set null
Qualifier

10、QSP
N Field Data Le Explanation
o Type ng
. th
1 Set ID - DSP 4 SI

166
Appendix B External Communication Protocol

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 – Message
DSP
1 Sample SN
2 Name
3 Gender
4 Age
5 Blood type
6 Group
7 Patient Number
8 Bed Number
9 Patient Type
10 Department
11 Sender
12 Inspector
13 Auditor
14 BLDV is for venous blood, BLDC is for peripheral
blood.
15 Remark
16 Sampling time, sending time
17 inspection time

Example
DSP|1||Mary||<CR>

167
Appendix B External Communication Protocol

B.3 Communication process

B.3.1 Analyzer transmits test results to lis server

ORU^R01
Analyzer Lis
server

<SB>
MSH
PID
PV1
OBR
OBX
OBX
……
<EB><CR>

OBX fields can be repeated. Transmitted test results include patient

information, 34 parameters, 2 histograms and 2 scatter plots. The 2
histograms and 2 scatter plots are BMP format and transmitted with base64
code.

For example：
Analyzer transmits test results to lis server
<SB>
MSH|^~\&|supplier|analyzer|LIS|PC|20110627144458||ORU^R01|0001|P|
2.3.1||||||UNICODE<CR>
PID|1||||||||<CR>

168
Appendix B External Communication Protocol

PV1|1|||<CR>
OBR|1||BAR101010101|supplier^Analyzer||||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|25|ED|RBCHistogram||
Analyzer^Image^BMP^Base64^Qk32lgMAAA……<CR>
OBX|26|ED|PLTHistogram||Analyzer^Image^BMP^Base64^Qk32lgMAAA……
<CR>
OBX|27|ED|S0_S10DIFFScattergram||

169
Appendix B External Communication Protocol

Analyzer^Image^BMP^Base64^Qk32lgMAAA……<CR>
OBX|28|ED|S90_S90DDIFFScattergram||
Analyzer^Image^BMP^Base64^Qk32lgMAAA……<CR>
<EB><CR>

170
 Appendix C Toxic and Hazardous Substances or

Elements

Toxic and Hazardous Substances or Elements

Polybro Polybromina
Parts Chromium
Plumbum Mercury（ Cadmium minated ted Diphenyl
VI（Cr(VI)
（Pb） Hg） （Cd） Bipheny Ethers（PB
）
ls(PBB) DE）

Shell ○ ○ ○ ○ ○ ○
Printed
circuit
○ ○ ○ ○ ○ ○
board
Assembly
Sheet
metal ○ ○ ○ ○ ○ ○
Parts

Host Plastic
○ ○ ○ ○ ○ ○
Parts
Machining
○ ○ ○ ○ ○ ○
parts
Hardware ○ ○ ○ ○ ○ ○
Flow
System ○ ○ ○ ○ ○ ○
Parts

Cable ○ ○ ○ ○ ○ ○
Accessories ○ ○ ○ ○ ○ ○

Packaging
○ ○ ○ ○ ○ ○
Materials

171
 Appendix C Toxic and Hazardous Substances or Elements

The table is compiled in accordance with SJ/T 11364.

○ ： The content of toxic or hazardous substance in the homogeneous materials of
the parts above is in the acceptable range of GB/T 26572.
×：The content of toxic or hazardous substance is exceed the acceptable range of
GB/T 26572 in at least one kind of homogeneous material of the parts above.
(The circuit board used lead solder in machining process and some parts of the
board contain plumb；And some sheet metal 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.

The electronic information products sold in the territory of

the People's Republic of China must mark this mark, and
the numbers in the mark represent the environmental
Pollution control signs of
protection period of the product under normal use.
electronic information
products

172
 Appendix D Daily Operation Procedure

D.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 4 minutes.
(4) Perform a blank 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.

D.2 Shutoff Procedures

(1) Click “Shutoff” 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.

D.3 Daily Maintenance (perform it before shutoff)

(1) 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”

173
Appendix D Daily Operation Procedure

and “Soak impedance transducer” procedures in the “Maint” interface.

(3) When continuously use the analyzer, shutoff procedure should be
performed at least once every 24 hours.

D.4 Weekly Maintenance

(1) The surface Maintenance of the analyzer.

(2) Clean the sample probe.

D.5 Monthly Maintenance

(1) Check and clean the reagent syringes.

(2) Mechanical parts Maintenance.

D.6 Other Maintenances

If the ruby aperture is block aging severely, please select “Clean Transducers”
procedure in the MAINT interface, and then put the probe cleaner under the
sample probe, and then according to the prompt dialog box to operate, and
then the analyzer will automatically inhale the probe cleaner into the
transducer to soak the ruby aperture.

174
Appendix E Key Components

SN Key Components

1 AMP board

2 Sample probe

3 One-way valve

4 Syringe

5 Stepper motor

6 Piston pump

7 Optocoupler

8 Solenoid Valve

9 Transducer

175
 Appendix F Attachment list

NO. Name Unit Quantity

Operation Manual of 5-Part-Diff Auto
1 Piece 1
Hematology Analyzer
2 Power cord Piece 1
3 Ground wire Piece 1
4 Serial line Piece 1
BNC Waste detection line*1
5 Piece 2
Waste outlet tubing*1
6 Disposable plastic test tube Piece 200
7 Fuse T3.15AL 250V Piece 2
8 Diluent inlet tubing Piece 1
9 Lyse inlet tubing Piece 1
10 Sheath inlet tubing Piece 1
11 Detergent inlet tubing Piece 1
12 Rubber drum Piece 1
Concentrated Probe
13 Bottle 1
Cleaner（100mL）
14 Grease Piece 1
15 Filter Piece 2
16 Sealing ring of large needle tube Piece 2
17 Sealing ring of small needle tube Piece 2
18 Socket Piece 1
Card sets of product maintenance Piece
19 1
records
20 maintenance record card Piece 1
21 rubber bucket lid wrench Piece 1

176