HT-5000

Auto Hematology Analyzer

Operation Manual
Intellectual Property

MR International Healthcare Technology Co.,Ltd.(hereinafter called MR) owns

the intellectual property rights to this product and this manual.

Without prior written consent of MR any person or entity is strictly forbidden to

use, disclose or allow others to obtain any information in this manual by any

means, and any materials contained in this manual shall not be

photocopied, reproduced or translated into other languages.

MR reserves the right to modify and update this manual without prior notice.

MR reserves the right of final interpretation for this manual.

Statement

The current version number of this manual is A/2, released on 2018-05. This manual

may be modified as needed without prior notice.

MR shall be liable for product safety, reliability and performance provided that

the following requirements are met:

1) All installation operations, expansions, changes, modifications and repairs of

this product are conducted by MR authorized personnel.

2) All replaceable parts involved in maintenance as well as the related accessories

and comsumables are original or approved by MR

3) Any associated electrical equipment complies with national standards and the

requirements of this manual.

4) Use and operation of this product are performed in strict accordance with this

manual.
Warranty Service

The entire machine is covered by a comprehensive warranty for a full year from the

date of production. However, damage occurring under the following conditions

shall not be covered by this warranty:

1) Man-made damage or damage caused by improper use.

2) Damage caused by mishandling during shipment.

3) Damage caused by uncontrollable natural factors such as earthquake, fire or

war.

4) Environment in which the machine is used does not meet the requirements

indicated in this manual.

5) Damage caused by use of an unspecified power supply or any other

abnormality in the power supply.

6) Damage caused as a result of maintenance performed by personnel not

authorized by MR

7) Malfunction of the instrument whose serial number is not legible enough.

8) Malfunction not caused by the instrument itself.

In the event you have any inquiries or questions while using the instrument,

you can always contact MR

Customer Service Department

Manufacturer: MR International Healthcare Technology Co.,Ltd.

Room 1501,Grand Millennium Plaza,181 Queen’s Road

Address:
Central,HK

Website URL: www.mr-healthcare.com

E-mail Address: sales@mr-healthcare.com

Tel: +852 21581807

Fax: +852 30116829

 This analyzer can only be operated by test professionals, doctors or laboratory

technicians who have been trained by MR or its distributors.

 It is important for the hospital or organization that employs this equipment to

carry out a reasonable service/maintenance plan. Neglect of this may result in

machine breakdown or injury of human health.

 Be sure to operate the analyzer under the situation specified in this manual;

otherwise, the analyzer will not work normally and the analysis results will be

unreliable, which would damage the analyzer components and cause personal

injury.

 This operation manual is written for the following laboratory professionals:

1) Daily system operators

2) Personnel for system maintenance and troubleshooting

3) Learners for system operation

 When the instrument reaches the retirement period, it is recommended to stop

using it or conduct a comprehensive inspection and maintenance before

re-using it again.
 Introduction

Introduction

We would like to sincerely thank you for choosing to purchase MR product.

Please read this manual carefully in order to ensure correct use of the product. After

carefully reading this manual, please keep it safely stored so that you can refer to it

when necessary.

Prodcut Name: Auto Hematology Analyzer

Model: HT-5000

This product primarily comprises the reagent and sample

loading units and mixing systems, photoelectric

Product Composition:
colorimetric assembly, cleaning system, data acquisition

unit, control unit and data processing system

This product is applicable for detecting the parameters of

Scope of Product WBC, RBC, PLT, HGB, etc. in anti-coagulated venous whole

Application: blood or capillary blood, as well as WBC 5-part differential

analysis and WBC counting

Date of Manufacture: See the nameplate of the instrument

Manual Revision Date: May 20, 2018

Item No.: P01.91.20180520-00

Manual Overview

This chapter explains how to use this operation manual, which is shipped with your

auto hematology analyzer and contains reference information about the analyzer

and procedures for operating, troubleshooting and maintaining the analyzer. Read

I
 Introduction

this manual carefully before operating your analyzer and operate your analyzer

strictly as instructed in this manual.

Who Should Read This Manual

This manual contains information written for clinical laboratory professionals or

trained doctors, nurses or laboratory technicians to:

1) Learn about hardware and software of the analyzer.

2) Set system parameters.

3) Perform daily operations.

4) Perform system maintenance and troubleshooting.

How to Find Information

This manual contains 11 chapters and 2 appendices. Refer to the table below to find

the information you need.

If you want to… Please refer to…

Chapter 1
Learn about safety and precautions of the
analyzer Safety and Precautions

Chapter 2
Learn about installation requirements of
the analyzer Installation

Chapter 3
Learn about the intended use, parameters,
structure, reagents, etc. of the analyzer System Description

Chapter 4
Learn about how the analyzer works
Working Principles

Chapter 5
Learn about the process of sample
collection and analysis, and how to use the Basic Operations

II
 Introduction

If you want to… Please refer to…

analyzer to perform your daily operating
tasks

Chapter 6
Review sample results
Reviewing Results

Learn about the basic requirements of Chapter 7

quality control and how to use the quality
Quality Control
control programs provided by the analyzer

Learn about the basic requirements of Chapter 8

calibration and how to calibrate the
Calibration
analyzer

Chapter 9
Learn about how to set/adjust system
settings Settings

Chapter 10
Learn about how to maintain/service the
analyzer Service

Chapter 11
Learn about how to solve the problems of
the analyzer Troubleshooting

Appendix A.
Learn about the technical specifications of
the analyzer Specifications

Appendix B.
Learn about the hazardous substances that
may contain in the analyzer parts Hazardous Substances

Chapter 1
Learn about safety and precautions of the
analyzer Safety and Precautions

Chapter 2
Learn about installation requirements of
the analyzer Installation

Symbols

You will find the following symbols in this manual:

III
 Introduction

Symbols Meaning

Alerts the operator to follow the statement below

the symbol, otherwise it may take the risk of
potential biohazard.

Alerts the operator to follow the statement below

the symbol while in operation, otherwise it may
cause personal injury.

Alerts the operator to follow the statement below

the symbol while in operation, otherwise it may lead
to analyzer damage or unreliable analysis results.

Alerts the operator to follow the statement below

the symbol, which emphasizes the important
information or special attention to be paid while in
operation.

You may find the following symbols on the analyzer, reagent, QC or calibrator:

Symbols Meaning

Consult accompanying documents.

Biohazard
(The background color of this symbol
is yellow, the symbol itself and the
outline is black.)

Laser beam warning

Equipotential symbol

Protective earthing

USB port

IV
 Introduction

Symbols Meaning

Network port

Alternating current

Authorized representative in the

European Community

The following definition of the WEEE

label applies to EU member states
only: The use of this symbol indicates
that this product should not be
treated as household waste. By
ensuring that this product is disposed
of correctly, you will help prevent
bringing potential negative
consequences to the environment and
human health. For more detailed
information with regard to returning
and recycling this product, please
consult the distributor from whom
you purchased the product.

For in vitro diagnostic use

Batch code

Expiry date

Product serial number

Date of manufacture

Be careful of the sample probe tip

V
 Introduction

Symbols Meaning

Manufacturer

Temperature limitation

Consult the operation manual

CE marking. The device is fully in

conformance with the Directive
98/79/EC on in vitro diagnostic
medical devices
This electronic product contains some
poisonous and harmful substances.
The environmental protection use
period is 20 years, after this period, it
should be put into the recycling
system.

Conventions

All illustrations provided in this manual are used for descriptive purposes or as
examples only, not intended to be used for any other purposes. They may not
necessarily reflect setup of the analyzer or data displayed.

VI
 Contents

Introduction ............................................................................................................................I
Manual Overview ..................................................................................................................I
Who Should Read This Manual ....................................................................................... II
How to Find Information................................................................................................... II
Symbols ................................................................................................................................ III
Conventions......................................................................................................................... VI
Chapter 1 Safety and Precautions ...................................................................................... 1-1
1.1 Safety ........................................................................................................................... 1-1
1.2 Precautions................................................................................................................. 1-3
Chapter 2 Installation............................................................................................................. 2-1
2.1 Introduction ............................................................................................................... 2-1
2.2 Installer........................................................................................................................ 2-1
2.3 Checking before Installation ................................................................................. 2-2
2.3.1 Inspection for Damage ................................................................................ 2-2
2.3.2 Packing List ..................................................................................................... 2-2
2.4 Installation Requirements ...................................................................................... 2-3
2.4.1 Space Requirements ..................................................................................... 2-3
2.4.2 Power Requirements .................................................................................... 2-4
2.4.3 Environmental Requirements..................................................................... 2-4
2.4.4 Moving and Installation Method .............................................................. 2-5
2.5 Precautions for Use.................................................................................................. 2-6
Chapter 3 System Description ............................................................................................. 3-1
3.1 Introduction ............................................................................................................... 3-1
3.2 Parameters ................................................................................................................. 3-1
3.3 Product Structure and Components ................................................................... 3-3
3.3.1 Status Indicator .............................................................................................. 3-5
3.3.2 Buzzer ............................................................................................................... 3-6
3.3.3 Power Switch .................................................................................................. 3-6
3.3.4 Sample Probe ................................................................................................. 3-6
3.3.5 Aspirate Key .................................................................................................... 3-7
3.3.6 Touch Screen .................................................................................................. 3-7
3.3.7. Analyzer Interfaces ...................................................................................... 3-7
3.3.8. External Printer (optional) .......................................................................... 3-7
3.3.9. External Devices............................................................................................ 3-8
3.4 Reagents, Controls and Calibrators ..................................................................... 3-8
3.4.1 Reagents .......................................................................................................... 3-9
3.4.2 Controls and Calibrators ........................................................................... 3-10
Chapter 4 Working Principles .............................................................................................. 4-1
4.1 Introduction ............................................................................................................... 4-1
4.2 Aspiration ..................................................................................................................... 4-1
4.3 Dilution ......................................................................................................................... 4-1
4.3.1 Whole Blood Mode ...................................................................................... 4-2
4.3.2 Prediluted Mode............................................................................................ 4-3
4.4 WBC Measurement .................................................................................................. 4-4
4.5 HGB Measurement................................................................................................... 4-5
4.5.1 Colorimetric Method.................................................................................... 4-5
4.5.2 HGB ................................................................................................................... 4-5
4.6 RBC/PLT Measurement ........................................................................................... 4-5
4.6.1 Electrical Impedance Method .................................................................... 4-5
4.6.2 Derivation of RBC-Related Parameters.................................................... 4-7
4.6.3 Derivation of PLT-Related Parameters ..................................................... 4-8
Chapter 5 Basic Operations .................................................................................................. 5-1
5.1 Introduction ............................................................................................................... 5-1
5.2 Initial Checks.............................................................................................................. 5-2
5.3 Startup and Login..................................................................................................... 5-3
5.4 Daily Quality Control ............................................................................................... 5-6
5.5 Sample Collection and Handling ......................................................................... 5-6
5.5.1 Sample Preparation ...................................................................................... 5-7
7
 Contents

5.5.2 Sample Analysis ............................................................................................. 5-9

5.5.3 Processing Analysis Results ...................................................................... 5-14
5.6 Standby ..................................................................................................................... 5-18
5.7 Shutdown ................................................................................................................. 5-20
Chapter 6 Reviewing Results ................................................................................................ 6-1
6.1 Introduction ............................................................................................................... 6-1
6.2 Browing in the “Review” Mode ........................................................................ 6-1
6.2.1 Table Area ....................................................................................................... 6-1
6.2.2 Graph Review ................................................................................................. 6-2
6.2.3 Check/Cancle Check (for administrators only) ...................................... 6-2
6.2.4 Delete (for administrators only) ................................................................ 6-3
6.2.5 Edit Information............................................................................................. 6-4
6.2.6 Edit Results...................................................................................................... 6-4
6.2.7 Search ............................................................................................................... 6-5
6.2.8 Print................................................................................................................... 6-6
6.2.9 Transmission ................................................................................................... 6-6
Chapter 7 Quality Control ..................................................................................................... 7-1
7.1 Introduction ............................................................................................................... 7-1
7.2 L-J QC .......................................................................................................................... 7-3
7.2.1 Editing L-J QC Settings (for administrators only) ................................. 7-3
7.2.2 Running L-J QC .............................................................................................. 7-6
7.2.3 Reviewing L-J QC Results............................................................................ 7-9
7.3 X-B QC ....................................................................................................................... 7-12
7.3.1 Introduction .................................................................................................. 7-12
7.3.2 Editing X-B QC Settings (for administrators only) ............................. 7-13
7.3.3 Running X-B QC .......................................................................................... 7-17
7.3.4 Reviewing X-B QC Results ........................................................................ 7-18
Chapter 8 Calibration ............................................................................................................. 8-1
8.1 Introdution ................................................................................................................. 8-1
8.2 When to Calibrate .................................................................................................... 8-3
8.3 How to Calibrate....................................................................................................... 8-3
8.3.1 Preparing Your Analyzer ............................................................................. 8-3
8.3.2 Manual Calibration ....................................................................................... 8-5
8.3.3 Calibration with Calibrator ......................................................................... 8-7
8.3.4 Calibration with Fresh Blood.................................................................... 8-11
Chapter 9 Settings .................................................................................................................. 9-1
9.1 Introduction ............................................................................................................... 9-1
9.2 Setting Up the Analyzer.......................................................................................... 9-2
9.2.1 System Setup.................................................................................................. 9-2
9.2.2 User Administration...................................................................................... 9-4
9.2.3 Parameter Setup............................................................................................ 9-7
9.2.4 Maintenance Setup (for administrators only) ....................................... 9-9
Chapter 10 Service................................................................................................................ 10-1
10.1 Introduction........................................................................................................... 10-1
10.2 Maintaining Your Analyzer ................................................................................ 10-2
10.2.1 Change Lyse, Change Diluent, Change Sheath ................................. 10-3
10.2.2 Flush aperture ............................................................................................ 10-4
10.2.3 Pack up ........................................................................................................ 10-4
10.3 Viewing Logs ......................................................................................................... 10-5
10.4 Version Info. .......................................................................................................... 10-6
Chapter 11 Troubleshooting .............................................................................................. 11-1
11.1 Introduction........................................................................................................... 11-1
11.2 Error Information and Handling....................................................................... 11-1

Appendix A Specifications ............................................................................ A-1

A.1 Classification ....................................................................................... A-1
A.2 Reagents ............................................................................................. A-1
A.3 Applicable Tubes .............................................................................. A-1
8
 Contents

B.4 Parameters .......................................................................................... A-2

A.5 Sampling Features ........................................................................... A-4
A.5.1 Sample Volumes Required for Each Analysis ................ A-4
A.5.2 Throughput ............................................................................ A-4
A.6 Performance Indicators .................................................................. A-4
A.6.1 Display Range ........................................................................ A-4
A.6.2 Background/Blank Count.................................................... A-5
A.6.3 Linearity Range...................................................................... A-5
A.6.4 Accuracy .................................................................................. A-6
A.6.5 Precision .................................................................................. A-6
A.6.6 Carryover................................................................................. A-7
A.7 Input/Output Device ....................................................................... A-7
A.7.1 External Computer (Optional) ........................................... A-7
A.7.2. Keyboard (Optional)............................................................ A-8
A.7.3. Mouse (Optional) ................................................................. A-8
A.7.4. External Barcode Scanner (Optional).............................. A-8
A.7.5. Printer (Optional) ................................................................. A-8
A.8 Interfaces ............................................................................................ A-8
A.9 Power Supply..................................................................................... A-8
A.10 Fuse ................................................................................................... A-8
A.11 EMC Description ............................................................................ A-8
A.12 Sound Pressure............................................................................... A-9
A.13 Operating Environment ............................................................... A-9
A.14 Storage Environment ..................................................................A-10
A.15 Running Environment.................................................................A-10
A.16 Dimensions and Weight.............................................................A-11
A.17 Safety Classification ....................................................................A-11
Appendix B Hazardous Substances ............................................................ B-1

9
 Safety and Precautions

Chapter 1Safety and Precautions

The following are warning symbols used for the analyzers. Ignoring these symbols

may result in death or serious injury. The order in which the symbols are given is in

no way indicative of importance and all symbols are of equal importance.

1.1 Safety

Bodily Injury

1) Keep away from the sharp parts of the analyzer, such as

sample probe tip, reagent probe tip and stirrer in case of

body injury.

2) Do not touch the moving parts, such as sample probe,

reagent probe, stirrer and fan when the analyzer is

running.

Laser

Do not look directly into any beams to prevent possible

damage to your eyes.

Electric Shock

1) Front, side and back covers mustn’t be opened when

the power is on, except by authorized service personnel.

2) Do not splash liquid on the analyzer’s countertop. In

1-1
 Safety and Precautions

case liquid gets into the analyzer, turn of the power and

contact Genrui or its local distributors immediately.

3) Keep away from the inside of computer and printer in

case of high voltage.

Biohazard

1) All test samples, calibrators, controls, etc., should be

considered contagious and protective gloves should be

worn when coming into contact with these objects.

2) All waste liquid should be considered contagious and

protective gloves should be worn when coming into

contact with it.

3) Parts that have contacts with samples, such as sample

probe, reagent probe, stirrer, cuvette, waste liquid tubing

and waste liquid container should be regarded as

contagious and protective gloves should be worn when

coming into contact with these objects.

4) When the instrument reaches its service life, it should be

disposed according to the requirements of the local

environmental protection department, cannot be

disposed and discarded as common wastes.

1-2
 Safety and Precautions

1.2 Precautions

Intended Use

1) The analyzer is designed for in vitro quantitative determination of

clinical chemistries in serum, plasma, urine and cerebrospinal fluid

(CSF) samples. Please consult MR first if you want to use the

system for other purposes.

2) To draw a clinical conclusion, please also refer to the patient’s

clinical symptoms and other test results.

Operator

The analyzer can only be operated by personnel who have

trained and authorized by MR or its local distributors.

Actions taken in case of failure

If the instrument has dangerous failure, such as fire, odor, smoke, etc.,

anyone can directly disconnect the power of the instrument or

the main power and contact MR immediately.

Operating Environment

1) Please install and operate the analyzer in an environment

specified by this manual. Installing and operating the analyzer in

other environment may lead to unreliable results and even

analyzer damage.

2) If the operating environment of the analyzer needs to be

1-3
 Safety and Precautions

modified, please contact MR or the authorized MR distributor

for you region.

Electromagnetic Interference

1) The analyzer is susceptible to electromagnetic interference during

operation which may affect test results and lead to operational

errors. Please do not use devices that emit electromagnetic

radiation, such as electric drills, mobile phones or interphones

while the analyzer is running

2) The analyzer will emit electromagnetic radiation during operation.

Do not install or use electromagnetically-sensitive devices near

the analyzer.

Improper Grounding

1) The power supply must be properly grounded, or there is a risk of

electric shock.

2) Ground impedance must be less than 0.1Ω. Poor grounding can

cause instability in test results and electrical leakage from the

enclosure, producing an electric shock hazard.

Liquid Leakage

1) Check the pipe joints for possible leakage before conducting

tests. Liquid leakage can cause inaccurate aspiration and

discharge volume.

2) Do not place reagents and samples on the analyzer bench to

1-4
 Safety and Precautions

avoid liquid spillage or leakage.

Probe Obstruction

Carefully check reagents and samples and make sure they do not

contain insoluble floating substance such as cellulose and protein

fibrin in case the probes may be blocked.

Water Quality

Water quality should meet Class 2 national standards for laboratory

water, otherwise damage to valve and pump as well as difficulty in

cleaning can be resulted.

Device Connection

1) For a device not permanently connected, please do not place it at

a location that is hard to disconnect.

2) For all the external switches or breakers and external over-current

protection device, it is recommended to place them near the

analyzer.

3) Devices connected with the network port of the analyzer should

conform to the requirements of National Standards GB4793 of

China as well as IEC60950.

Analysis Parameters

Perform calibration for different batches of reagents. Incorrect

analysis parameters can lead to wrong test results. Please

consult MR or your reagent supplier for more information.

1-5
 Safety and Precautions

Treating Waste Analyzer

Materials of the analyzer are subject to contamination regulations.

Dispose of the waste analyzer in accordance with your local or

national guidelines for waste disposal.

1-6
 Installation

Chapter 2Installation

2.1 Introduction

The analyzer is tested and packed with care before it is shipped from the factory.

Inspect the carton carefully when you receive your analyzer. If any sign of damage

is found, contact MR customer sercive department or your local distributor

immediately.

 Installation by personnel not authorized or trained by MR may cause

personal injury or damage your analyzer. Do not install your analyzer without

the presence of MR-authorized personnel.

 The installation, authorization, upgrade and modification of the analyzer

software must be performed by MR-authorized personnel.

2.2 Installer

The analyzer should only be installed by MR personnel or MR-

authorized distributor. Users should provide appropriate environment and

space for the installation. When the analyzer needs to be relocated, please

contact MR or MR-authorized distributor. When you received your analyzer,

please immediately notify MR or its authorized local distributor.

2-1
 Installation

2.3 Checking before Installation

2.3.1 Inspection for Damage

All the analyzers have been inspected strictly by MR before packing and

shipping. When you received your analyzer, before opening the packaging, perform

a thorough inspection and note whether there is any of the following damage:

1) Up-side-down or distortion of the packaging.

2) Obvious water marks on the packaging.

3) Obvious signs of being striked on the packaging.

4) Packaging shows signs of having been opened previously.

If you notice any of the above instances of damage, please immediately

notify MR or MR-authorized local distributor.

If the outer packaging is intact, unpack it in the presence of MR staff and/or

authorized distributor personnel, and conduct the following inspection:

1) Check all the parts against the packing list contained inside the packaging.

2) Check the surface of all the parts for any crack, strike or distortion.

If you notice any shipment damage or missing part, please immediately

notify MR or MR-authorized local distributor.

2.3.2 Packing List

Check all the parts according to the packing list contained inside the packaging. If

2-2
 Installation

you notice any missing part, please immediately notify MR or its authorized local

distributor.

 Check the accessories in the supplied service pack, which is also included in the
packing list.

2.4 Installation Requirements

2.4.1 Space Requirements

Check the site for proper space allocation. In addition to the space required for the

analyzer itself, arrange for:

1) proper height to place the analyzer;

2) at least 50cm between the left and right side door of the analyzer and the walls,

which is the preferred access to perform service procedures;

3) at least 20cm behind the analyzer for cabling and ventilation.

 There should be enough room on and below the countertop to accommodate

the reagents and waste containers.

 The diluent container shall be put within 1.0m under the analyzer, lyse

containers are placed inside the analyzer.

 The countertop (or the floor) where the analyzer is placed shall be able to

withstand at least 40kg of weight.

2-3
 Installation

2.4.2 Power Requirements

Table 2-1 Power specification

Voltage Input power Frequency

Analyzer (100-240V～) ±10% 100-120VA (50Hz/60Hz)±1Hz

 Make sure the analyzer is properly grounded.

 Before turning on the analyzer, make sure the input voltage meets the

requirements.

 Using pinboard may bring the electrical interference and the analysis results

may be unreliable. Please place the analyzer near the electrical outlet to avoid

using the pinboard.

 Please use the original power cable shipped with the analyzer. Using other

power cable may damage the analyzer or cause unreliable analysis results.

2.4.3 Environmental Requirements

1) Operating temperature range: 10℃~35℃

2) Relative humidity: 20%~85%

3) Atmospheric pressure: 70.0kPa~106.0kPa

2-4
 Installation

 The environment shall be as free as possible from dust, mechanical vibrations,

loud noises, and electrical interference.

 It is advisable to evaluate the electromagnetic environment prior to operation

of this analyzer.

 Keep the analyzer away from strong sources of electromagnetic interference, as

these may interfere with the proper operation.

 Do not place the analyzer near brush-type motors, flickering fluorescent lights,

and electrical contacts that regularly open and close.

 Do not place the analyzer in direct sunlight or in front of a source of heat or

wind.

 The environment shall be ventilated.

 Place the analyzer on a horizontal flat surface.

 Connect only to a properly earth grounded outlet.

 Only use this analyzer indoors.s

2.4.4 Moving and Installation Method

Moving and installation of the analyzer shall be conducted by MR-authorized

personnel. Do not move or install your analyzer without the presence

of MR-authorized personnel or local distributor.

 Installation by personnel not authorized or trained by MR may cause

2-5
 Installation

personal injury or damage your analyzer. Do not install your analyzer

without the presence of MR-authorized personnel or local distributor.

 Before the analyzer is shipped out, the sample probe is fixed by a plastic cable

tie to avoid damaging the sample probe during transportation. Remove the

cable tie before using the analyzer.

2.5 Precautions for Use

1) The analyzer performance may be declined if it has been placed in

environment of high dustiness.

2) The surface of the analyzer shall be cleaned and sterilized regularly with alcohol

(75%).

3) The aspirate key of the analyzer (see Figure 2-1 Front view of the analyzer) shall

be wiped with alcohol (75%) regularly.

4) Sample collection and preparation must be done following standard

procedures.

5) If any of the pipes or fluidic components is worn out, stop using the analyzer

and contact Genrui customer service department immediately for inspection or

replacement.

6) Check and make sure the pipes of reagents, including diluent, lyse and waste,

are not pressed or bent.

2-6
 Installation

7) You must only use the MR-specified reagents, otherwise the analyzer may

be damaged or provide unreliable results.

8) Pay attention to the expiration dates and open-container stability days of all

the reagents. Be sure not to use expired reagents.

2-7
 System Description

Chapter 3System Description

3.1 Introduction

This chapter introduces the parameters, major components, interfaces, buttons,

menus, software help system, operation information and reagent system of the

HA-5000 Auto Hematology Analyzer.

3.2 Parameters

The analyzer determines 25 parameters, 2 histograms and 2 scattergram of blood

samples. The parameters under CBC and CBC+DIFF mode are listed as follows:

Table 3-1 Parameters

Parameter
Name Abbreviation CBC CBC+5Diff
Group

White Blood Cell count WBC √ √

Lymphocytes number Lym# × √

WBC group（ 11 items）

Lymphocytes percentage Lym% × √

Monocytes number Mon# × √

Monocytes percentage Mon% × √

Neutrophils number Neu# × √

3-1
 System Description

Neutrophils percentage Neu% × √

Eosinophils number Eos# × √

Eosinophils percentage Eos% × √

Basophils number Baso# × √

Basophils percentage Baso% × √

Red Blood Cell count RBC √ √

Hemoglobin Concentration HGB √ √

Hematocrit HCT √ √

Mean Corpuscular Volume MCV √ √

RBC group（ 8 items）

Mean Corpuscular Hemoglobin MCH √ √

Mean Corpuscular Hemoglobin

MCHC √ √
Concentration

Red Blood Cell Distribution

RDW-CV √ √
Width - Coefficient of Variation

Red Blood Cell Distribution

RDW-SD √ √
Width - Standard Deviation
PLT group（

Platelet count PLT √ √

Mean Platelet Volume MPV √ √

6 items）

Platelet Distribution Width PDW √ √

3-2
 System Description

Plateletcrit PCT √ √

Platelet Large Cell Ratio P_LCR √ √

Platelet Large Cell Count P_LCC √ √

Table 2-2 Histograms

Name Abbreviation CBC CBC+5Diff

Red Blood Cell Histogram RBC Histogram √ √

Platelet Histogram PLT Histogram √ √

Table 2-3 Scattergrams

Name Abbreviation CBC CBC+5Diff

Size Scattergram Size × √

Differential Scattergram Diff × √

 “√” means “available under the mode”, “×” means “not available

under the mode”.

3.3 Product Structure and Components

The analyzer mainly consists of a host, accessories and client software. The host

comprises a display screen, aspirate key, fluidic system, optical system, circuit board,

power interface, reagent interface and signal interface.

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 System Description

Figure 2-1 Front view of the analyzer

1-- Aspiratekey 2-- Sample probe 3-- Probe wipe block

4-- Touch screen 5-- Indicator

Figure 2-2 Back view of the analyzer

1--Waste outlet 2--Diluent inlet 3-- Waste detector

4--Power input socket 5-- Power switch

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 System Description

Figure 2-3 Left view of the analyzer (left door open)

1--Network/USB por 2--Sheath reagent position

3-- Lyse reagent position 4-- Panel module

3.3.1 Status Indicator

The status indicator is on the front of the analyzer. It indicates the ready, running,

error and standby status of the analyzer.

The indicator illuminates in 4 colors to indicate the current status of the analyzer.

See the following table:

Table 2-4 Indicator and analyzer status

Analyzer status Indicator Remark

Whole blood mode ready Green light on Sequence is allowed

Prediluent mode ready Blue light on Sequence is allowed

Running Yellow light on Sequence is being performed

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 System Description

Analyzer status Indicator Remark

An error has occurred and the

Stop with fault Red light on
analyzer is not running

3.3.2 Buzzer

The buzzer indicates errors of the analyzer. When you click the touch screen or the

error is cleared, the alarming sound of the buzzer can be cleared.

3.3.3 Power Switch

The power switch is on the back of the analyzer. It is used to turn the analyzer on

and off.

 Do not turn on/off the switch repeatedly in a short time to avoid damaging the

analyzer.

3.3.4 Sample Probe

The sample probe is on the front of the analyzer. It is used to aspirate blood

samples accurately and quantitatively.

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 System Description

3.3.5 Aspirate Key

The aspirate key is located behind the sample probe. Press it to start analysis,

dispense diluent or exit from standby mode.

3.3.6 Touch Screen

The touch screen is on the front of the analyzer. You can use it to perform interface

operations and complete the display of information.

3.3.7.Analyzer Interfaces

1) Power interface

Used to plug in the power cable connected to the network power supply.

2) Reagent/Waste outlet

Used to connect with reagents and waste container via fluidic pipes.

3) USB/Network port

The USB port and network port are on the left of the analyzer. They can be used

to connect the keyboard, printer, etc., and to transmit data.

3.3.8.External Printer (optional)

The printer is connected to the USB port on the left of the analyzer for printing

reports and other on-screen displays.

The supported external printer models are: EPSON LQ-590K, HP Laser Jet P1505N,
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 System Description

HP Office Jet Pro K5300, HP LaserJet P1606DN.

3.3.9.External Devices

1) Keyboard (optional)

The keyboard is connected to the analyzer via the interface on the back of the

analyzer.

2) Mouse (optional)

The mouse is connected to the analyzer via the interface on the back of the

analyzer. It is used to operate the analyzer.

3.4 Reagents, Controls and Calibrators

As the analyzer, reagents (diluent, lyse and probe cleanser), controls, and calibrators

are components of a system. Performance of the system depends on the

combined integrity of all components. Only MR-specified reagents (see

Appendix A Specifications), which are formulated specifically for the fluidic

system of your analyzer in order to provide optimal system performance, could

be used. Do not use the analyzer with reagents from multiple suppliers.

Otherwise, the analyzer may not meet the performance specified in this manual

and may provide unreliable results. All references related to reagents in this

manual refer to the reagents specifically formulated for this analyzer.

Each reagent package must be examined before use. Product integrity may be

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 System Description

compromised in packages that have been damaged. Inspect the package for signs

of leakage or moisture. If there is evidence of leakage or improper handling, do not

use the reagent.

 Store and use the reagents as instructed by instructions for use of the reagents.

 When you have changed the diluent or lyse, implement a background test to

see if the results meet the requirement.

 Pay attention to the expiration dates and open-container stability days of all

the reagents. Be sure not to use expired reagents.

3.4.1 Reagents

1) HA 5D 01Diluent

It is used to dilute blood samples and provide a stable environment for

counting and sizing blood cells.

2) HA 5S 02Lyse

It is used to lyse red blood cells and differentiate WBCs.

3) HA 5L 03 Sheath

It is used to lyse red blood cells, count and differentiate WBCs, and determine

the HGB.

4) Probe cleanser

It is used to clean the analyzer regularly.

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 System Description

3.4.2 Controls and Calibrators

The controls and calibrators are used to verify accurate operation of and calibrate

the analyzer.

The controls are commercially prepared whole-blood products used to verify that

the analyzer is functioning properly. They are available in low, normal, and high

levels. Daily use of all levels verifies the operation of the analyzer and ensures that

reliable results are obtained. The calibrators are commercially prepared

whole-blood products used to calibrate the analyzer. Store and use the controls

and calibrators as instructed by their instructions for use.

All references related to controls and calibrators in this manual refer to the

controls and calibrators specifically formulated for this analyzer by MR You must

buy those controls and calibrators from MR or MR-authorized distributors.

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 Working Principles

Chapter 4Working Principles

4.1 Introduction

The measurement methods used in this analyzer are: the Electrical Impedance

method for determining the RBC and PLT data; the colorimetric method for

determining the HGB; flow cytometry by laser for determining the WBC data. Other

parameter results are obtained via calculation.

4.2 Aspiration

If you are to analyze a whole blood sample in the open vial sampling mode, the

analyzer will aspirate 28μL (CBC+DIFF mode) or 10.5μL (CBC mode) of the sample.

If you are to analyze a capillary blood sample in the open vial sampling mode, you

should first manually dilute the sample (20μL of capillary sample needs to be

diluted by 500μL of diluent, dilution ratio: 1:26) and then present the pre-diluted

sample to the analyzer, which will aspirate 220μL of the sample.

4.3 Dilution

The aspirated sample will quickly and precisely be diluted in RBC bath and then

segmented into two portions. One of these two portions will then be diluted again

and processed by different reagents. After this, they are ready for analysis.

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 Working Principles

This analyzer can process two types of blood samples - whole blood samples and

prediluted samples.

4.3.1 Whole Blood Mode

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 Working Principles

4.3.2 Prediluted Mode

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 Working Principles

4.4 WBC Measurement

Figure 4-1 WBC Measurement

After a predetermined volume of blood is aspirated and diluted by a certain

amount of reagent, it is injected into the flow cell. Surrounded with sheath fluid

(diluent), the blood cells pass through the center of the flow cell in a single column

at a faster speed. When the blood cells suspended in the diluent pass through the

flow cell, they are exposed to a laser beam. The intensity of scatter light reflects the

blood cell size and intracellular density. The low-angle scattered light reflects cell

size, and the high-angle scattered light reflects intracellular density (nucleus size

and density). The optical detector receives this scatter light and converts it into

electrical pulses. Pulse data collected can be used to draw a 3-dimensional

distribution (scattergram).

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 Working Principles

4.5 HGB Measurement

4.5.1 Colorimetric Method

The WBC/HGB dilution is delivered to the HGB bath where it is bubble mixed with a

certain amount of lyse, which converts hemoglobin to a hemoglobin complex that

is measurable at 530nm. An LED is mounted on one side of the bath and emits a

beam of monochromatic light, whose central wavelength is 530nm. The light passes

through the sample and is then measured by an optical sensor that is mounted on

the opposite side. The signal is then amplified and the voltage is measured and

compared to the blank reference reading (readings taken when there is only diluent

in the bath), and the HGB is measured and calculated in the analyzer automatically.

4.5.2 HGB

The HGB is calculated per the following equation and expressed in g/L.

Blank Photocurrent
HGB = Constant × Ln
Sample Photocurrent

4.6 RBC/PLT Measurement

4.6.1 Electrical Impedance Method

RBCs/PLTs are counted and sized by the electrical impedance method. This method

is based on the measurement of changes in electrical resistance produced by a

particle, which in this case is a blood cell, suspended in a conductive diluent as it

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 Working Principles

passes through an aperture of known dimensions. A pair of electrodes is

submerged in the liquid on both sides of the aperture to create an electrical

pathway. As each particle passes through the aperture, a transitory change in the

resistance between the electrodes is produced. This change produces a measurable

electrical pulse. The number of pulses generated represents the number of particles

that passed through the aperture. The amplitude of each pulse is proportional to

the volume of each particle.

Figure 4-2 Electrical Impedance Method

Each pulse is amplified and compared to the internal reference voltage channel,

which only accepts the pulses of certain amplitude. If the pulse generated is above

the RBC/PLT lower threshold, it is counted as a RBC/PLT. The analyzer presents the

RBC/PLT histogram, whose x-coordinate represents the cell volume (fL) and

y-coordinate represents the number of the cells.

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 Working Principles

4.6.2 Derivation of RBC-Related Parameters

1) RBC

RBC (1012/L) is the number of erythrocytes measured directly by counting the

erythrocytes passing through the aperture.

2) MCV

Based on the RBC histogram, this analyzer calculates the mean cell volume

(MCV) and expresses the result in fL.

3) HCT, MCH, and MCHC

This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows:

×
HCT =
10

MCH =

MCHC = × 100

Where the RBC is expressed in 1012/L, MCV in fL and HGB in g/L.

4) RDW-CV

Based on the RBC histogram, this analyzer calculates the CV (Coefficient of

Variation) of the erythrocyte distribution width, which is expressed in %.

5) RDW-SD

Based on the standard deviation of erythrocyte size distribution, this analyzer

calculates the RDW-SD, its unit is fL.

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 Working Principles

4.6.3 Derivation of PLT-Related Parameters

1) PLT

PLT (109/L) is measured directly by counting the platelets passing through the

aperture.

2) MPV

Based on the PLT histogram, this analyzer calculates the mean platelet volume

(MPV, fL).

3) PDW

Platelet distribution width (PDW) is the geometric standard deviation (GSD) of

the platelet size distribution. Each PDW result is derived from the platelet

histogram data and is reported as 10(GSD).

4) PCT

This analyzer calculates the PCT as follows and expresses it in %.

×
PCT =
100000

Where the PLT is expressed in 109/L and the MPV in fL.

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 Basic Operations

Chapter 5Basic Operations

5.1 Introduction

This chapter provides step-by-step procedures for operating your analyzer on a

daily basis. The operation process of sample analysis in different working modes is

described in detail.

 All samples, controls, calibrators, reagents, wastes and areas contacted them

are potentially biohazardous. Wear proper personal protective equipment (e.g.

gloves, lab coat, etc.) and follow safe laboratory procedures when handling

them and contacted areas in laboratory.

 Do not contact the patients’ sample blood directly.

 Be sure to dispose of reagents, waste, samples, consumables, etc. according to

government regulations.

 The reagents are irritating to eyes, skin and mucosa. Wear proper personal

protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory

procedures when handling them and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or into your eyes, rinse the area with

plenty of clean water and seek medical attention immediately.

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 Basic Operations

 Keep your clothes, hairs and hands away from the moving parts to avoid injury.

 The sample probe tip is sharp and may contain biohazardous materials.

Exercise caution to avoid contact with the probe when working around it.

 Do not reuse disposable products such as collection tubes, test tubes, capillary

tubes and so on.

 Use the reagents specified by the MR only. Store and use the reagents as

instructed by instructions for use of the reagents.

 Check if the reagent tubes are properly connected before using the analyzer.

 Be sure to use clean EDTAK2 or EDTAK3 anticoagulant collection tubes, fused

silica glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary

tubes.

 Be sure to use the evacuated collection tubes recommended in the Appendix.

 Be sure to use the MR-specified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

5.2 Initial Checks

Perform the following checks before turning on the analyzer:

1) Checking the waste container

Check and make sure the waste container is not full.

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 Basic Operations

2) Checking reagents

Check to see if the reagents are expired or frozen. Reagents must be

equilibrated for 24 hours before use.

3) Checking tubing and power connections

Check and make sure the reagents, waste and pneumatic unit tubes are

properly connected and not bent.Check and make sure the power cable of the

analyzer is properly plugged into the power outlet.

4) Checking the printer (optional)

Check and make sure enough printer paper is installed. Check and make sure

the power cable of the printer is properly plugged into power outlet, and the

printer is properly connected to the analyzer.

5.3 Startup and Login

1) Start up the analyzer:Change the power switch at the backside to ON position

(“I”) will power on the instrument.

2) The indicator light turns on.

3) Background check, which is the measurement of particle and electric

interference by the analyzer.

If the results of the first background check do not meet the requirement, the

analyzer will perform background check again.

The sample ID of background check results is “background”.

The error message “Background abnormal” will be given when the

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 Basic Operations

background results are out of range.

4) Enter the current user name and the password respectively into the “User

Name” box and the “Password” box.

 If the software cannot be started successfully after being launched for several

times, contact MR customer service department or the authorized

distributors.

 After starting up the analyzer, check if the date/time is correct.

 The default user name and password for administrator are both “Admin”.

 The user name and password may be consisted of 1-12 letters, and the

password cannot be null.

5) Click “Login” to enter the system.

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 Basic Operations

 If error occurs during the initialization process (e.g., background check fails),

the analyzer will report the error. See Chapter 11 Troubleshooting for the

solution.

 See Appendix A Specifications for the background range of each parameter.

 The system opens different function for the user according to the user level.

The user level depends on the user name and the password when the user logs

in.

 If user switching is necessary, click the “Logout” icon on the system menu.

Enter the desired user name and the password into the pop-up dialog box and

click the “OK” button to log in.

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 Basic Operations

 Running sample with the background abnormal error present will lead to

unreliable results.

5.4 Daily Quality Control

Perform daily quality control before running any samples. See Chapter 7 Quality

Control for details.

5.5 Sample Collection and Handling

 All the samples, controls, calibrators, reagents, wastes and areas contacted

them are potentially biohazardous. Wear proper personal protective

equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures

when handling them and the contacted areas in the laboratory.

 The sample probe is sharp and potentially biohazardous. Do not contact the

sample probe during operations.

 Do not reuse disposable products such as collection tubes, test tubes, capillary

tubes and so on.

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 Basic Operations

 Make sure the probe tip does not contact the sample tube to avoid potential

spillage.

5.5.1 Sample Preparation

The analyzer can run 3 types of samples: whole blood samples, capillary whole

blood samples and prediluted samples.

 Prepare samples following the recommend procedure of the manufacturer.

 All samples shall be mixed as shown in the following figure.

1) Whole blood samples

a) Use clean EDTAK2 or EDTAK3 anticoagulant collection tubes to collect

venous blood samples.

b) Mix the sample according to your laboratory’s protocol.

 Be sure to collect at least 0.5mL of blood to ensure the accuracy of the results.

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 Basic Operations

2) Pre-diluted samples

a) Click the diluent dispensing icon, the following dialog box pops up.

b) Present a clean tube to the sample probe, press the aspirate key to

dispense diluents (500μL). The dispensing progress bar will be displayed

on the screen.

c) To continue with diluent dispensing, repeat the step 1-2.

d) Add 20μL of venous blood or capillary blood to the diluent, close the tube

cap and mix it properly according to your laboratory’s protocol.

e) Click “Cancel” after preparing all the samples, the analyzer will clean the

sample probe automatically.

 You can also use pipette to aspirate 500μL of diluent.

 Be sure to keep dust from the prepared diluent.

 After mixing the capillary sample with the diluent, be sure to wait 3 minutes

and then remix before running the sample.

 Be sure to run the pre-diluted samples within 30 minutes after the mixing.

 Be sure to mix any sample that has been prepared for a while before running it.

Do not mix the samples with massive force using swirl mixer.

 Be sure to evaluate pre-diluted stability based on your laboratory’s sample

population and sample collection techniques or methods.

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 Basic Operations

5.5.2 Sample Analysis

Click “Sample Analysis” to enter the sample analysis screen. Click “Sample Mode”

button to select “Whole Blood”, “Prediluted” mode, or Click “Analysis Mode”

to select “CBC”, “CBC+5DIFF” or “CBC+5DIFF+RRBC” mode.

1) Entering sample information

The analyzer provides two ways for you to enter sample information: entering

sample ID only and entering all sample information.

If you want to enter sample information after analysis, you may skip this

chapter, and enter sample information at the result review screen (see Chapter

6 Reviewing Results). You may first set up the way to enter sample information

at the “Setup → System Setup → Auxiliary Setup” screen as instructed in

Chapter 9 Settings, then you may enter sample information at the sample

analysis screen.

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 Basic Operations

a) Entering the ID

Enter the ID in the “ID” box.

b) Entering the medical record number

Enter the medical record number in the “Sample No.” box.

c) Entering the patient name

Enter the patient name into the “Name” box.

d) Selecting patient gender

Select patient gender from the “Gender” pull-down list. There are two

options: “Male” and “Female”.

e) Selecting blood type

Select patient gender from the “Blood type” pull-down list.

f) Entering the patient’s age

The analyzer provides four ways for you to enter the patient’s age - in

years, in months, in days and in hours. The first way is designed for the
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 Basic Operations

adult or pediatric patients no younger than one year; the second for the

infant patients one month to two years; the third for the neonatal no older

than one month, and the fourth for the neonatal no older than 48 hours.

You may choose one of the four ways to enter the patient age.

g) Entering the patient type

Select patient type from the “Patient Type” pull-down list.

h) Entering the department name

Enter the name of the department into the “Department” box or select it

from the “Department” pull-down list (when there are previously saved

records in the list). The saved contents will be added in the pull-down list

automatically.

i) Entering the bed number

Enter the number of the patient’s bed into the “Bed No.” box.

j) Entering the sampling time

Enter the time when the sample is collected into the “Sampling Time”

box.

k) Entering the delivery time

Enter the delivery time of analysis into the “Send Time” box.

l) Entering the clinician

To enter the name of the person who sent the sample for analysis, enter

the name into the “Sender” box or select the desired name from the

“Sender” pull-down list (if there are previously saved names in the list).

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 Basic Operations

The saved contents will be added in the pull-down list automatically.

m) Entering comments

Enter comments in the “Comments” box.

n) OK

When you have finished entering the work list information, click the “OK”

button to save the changes and return to the sample analysis screen.

o) Cancel

If you do not want to save the entered work list information, click the

“Cancel” button to return to the sample analysis screen without saving

the changes.

2) Selecting mode

Make sure the analyzer indicator is solid green. Select whole blood (CBC+DIFF

or CBC), or prediluted (CBC+DIFF or CBC) mode based on your needs on the

mode selection screen. The selected mode will be displayed at the bottom of

the screen.

3) Aspirating sample

Present the sample to the sample probe. Press the aspirate key to start the

analysis.

4) Removing the sample

The sample probe will automatically aspirate sample. When you hear the beep

sound, you may remove the sample.

5) Auto analysis and result reporting

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 Basic Operations

The analyzer will automatically run the sample. When the analysis is finished,

the results will be displayed on the screen.

 During the analysis, if errors like clog or bubble occur, the analyzer will

automatically display results of related parameters as invalid, and alarm

information will show on the error information area. See Chapter 11

Troubleshooting for the way to remove errors.

 If the ambient temperature is out of the allowed range, thus causing the

analyzer temperature (the temperature tested by the sensor inside the

analyzer) goes out its specified range, the analyzer will alarm you for abnormal

ambient temperature and the analysis results may be unreliable. See Chapter

11 Troubleshooting for solutions.

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5.5.3 Processing Analysis Results

1) Saving analysis results automatically

The analyzer automatically saves sample results. When the maximum number

of results that can be saved has been reached, the newest result will overwrite

the oldest.

2) Printing and Transmission to LIS

If “Auto print after sample analysis” function is enabled, the analyzer will print

reports automatically; and if “Auto communicate” function is enabled, the

analysis results, sample and patient information will be transmitted to LIS

automatically.

3) Parameter flags

See the following section for details about parameter flags.

If the parameter is followed by a “H” or “L”, it means the analysis result has

exceeded the upper or lower limit of the reference range (See section 9.2.4 Ref.

range).

If the parameter is followed by an “R”, it means the analysis result is

questionable.

If you see “*****”, as opposed to the result, it means the result is invalid; if

you see “+++++”, as opposed to the result, it means the result is out of the

display range (See Table 5-1 Display range for details).

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 Basic Operations

Table 5-1 Display range

Parameter Display Range

WBC 0.00 ～ 999.99×109/L

Baso#、Neu#、Eos#、Mon#、Lym# 0.000～ 999.999×109/L

Baso%、Neu%、Eos%、Mon%、Lym% 0.00 ～ 99.99 %

RBC 0.00 ～ 18.00 ×1012/L

HGB 0 ～ 300 g/L

HCT 0.0 ～ 80.0 %

MCV 0.0 ～ 250.0 fL

MCH 0.0 ～ 999.9 pg

MCHC 0 ～ 9999 g/L

RDW-SD 0.0 ～ 999.9 fL

RDW-CV 0.0 ～ 99.9 %

PLT 0 ～ 9999 ×109/L

PDW 0.0 ～ 99.9

MPV 0.0 ～ 99.9 fL

PCT 0.00 ～ 0.99 %

P_LCR 0.00 ～ 99.99 %

P_LCC 0 ～ 9999 ×109/L

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 Basic Operations

4) Flags of abnormal blood cell differential or morphology

The following table lists all flags and their indications.

Table 5-2 Flags of abnormal blood cell differential or morphology

Flag
Flag Meaning Judgment criterion
Type

Interference of PLT clump The DIFF and BASO

WBC Abnormal or NRBC to WBC count and channels are

differential may exist unproportionate.

Leucopenia Low WBC analysis results WBC < 2.50×109/L

Leucocytosis High WBC analysis results WBC > 18.00×109/L

Low neutrophils analysis

Neutropenia NEU# < 1.000×109/L
results
WBC

Flag
High neutrophils analysis
Neutrophilia NEU# > 11.000×109/L
results

Low lymphocytes analysis

Lymphopenia LYM# < 0.800×109/L
results

High lymphocytes analysis

Lymphocytosis LYM# > 4.000×109/L
results

Monocytosis High lymphocytes analysis MON# > 1.500×109/L

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 Basic Operations

Flag
Flag Meaning Judgment criterion
Type

results

High eosinophils analysis

Eosinophilia EOS# > 0.700×109/L
results

High basophils analysis

Basophilia BASO# > 0.200×109/L
results

WBC < 4.0×109/L

Pancytopenia WBC, RBC and PLT low RBC < 3.5×1012/L

PLT < 100×109/L

Possible presence of

microcytes, macrocytes,
RBC Histogram The distribution of RBC
anisocytosis, RBC
Abn. histogram is abnormal
agglutination and

RBC
dimorphic histogram

Flag

HGB abnormal or RBC

HGB agglutination, or MCHC > 380 g/L

Abn./Interfere? interference may exist (e.g., or HGB interference

WBC high)

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 Basic Operations

Flag
Flag Meaning Judgment criterion
Type

Microcytosis MCV low MCV < 70fL

Macrocytosis MCV high MCV > 110fL

Anemia Anemia HGB < 90g/L

Erythrocytosis RBC high RBC > 6.50×1012/L

Possible presence of

PLT Scattergram microcytes, red blood cell The distribution of PLT

Abn. debris, giant PLT or PLT scattergram is abnormal

PLT
clump
Flag

Thrombopenia PLT low PLT < 60×109/L

Thrombocytosis PLT high PLT > 600×109/L

5.6 Standby

When the time for which the analyzer is free from fluidic operations reaches that

you have set at the “Setup” screen of the analyzer (default setting is 15 minutes),

The analyzer will enter standy status, the screen will switch off automatically, and

the probe will be drew back automatically.

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 The analyzer will not enter standby status from the Status screen.

 If it is time for auto-standby and the analyzer is reporting error, then the error

must be resolved first.

 During this condition, you can still perform any other operations (e.g., printing

and transmission) other than fluidic operations.

 Refer to Section 9.2.4 Maintenance Setup for how to edit waiting time before

entering standby mode.

 Under standby mode, if there are unfinished printing or communication tasks,

the analyzer will go on processing them.

1) Aspirate key

Press the aspirate key to exit the standby status.

2) Touch screen

Touch the screen to exit the stanby status.

 When exiting from the standby status, the analyzer will perform different

maintenance operations based on the time consumed entering standby status.

 If error occurs when the analyzer is exiting from the standby status, see Chapter

11 Troubleshooting for solutions.

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 After exiting the standby status, the analyzer will resume its original status. The

Analysis icon will turn into solid green. And the analyzer indicator will also turn

into solid green.

5.7 Shutdown

Perform the shutdown procedure to shut down the analyzer daily.

1) Click the shutdown button on the menu and the following shutdown dialog

box will display.

2) Click “OK”.

3) When dialog box prompting probe cleanser maintenance displays, place probe

cleanser to the sample probe and press aspirate key. The probe will aspirate

probe cleanser automatically.

4) After shutting down finishes, the message “Please turn off the power of the

analyzer!” will be displayed. Press the Power switch on back of the instrument

to power off.

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 Be sure to dispose of reagents, waste, samples, consumables, etc. according to

government regulations.

 Do not start up the analyzer immediately after it is shut down. Wait for at least

10 seconds.

 To ensure stable analyzer performance and accurate analysis results, be sure to

perform the shutdown procedure to shut down the analyzer after it has been

running continuously for 24 hours.

 Do not disconnect power during the shutdown process.

 If error that will affect shutdown occurs during the showdown process, the

analyzer will resume to its original status and report the error. See Chapter 11

Troubleshooting for solutions.

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 Reviewing Results

Chapter 6Reviewing Results

6.1 Introduction

The analyzer automatically saves analysis results. You can review all the analysis

results, scattergrams and histograms either in table or graph mode.

6.2 Browing in the “Review” Mode

Operators can review, validate, search, edit and export saved results on the “Data”

screen. Click “Data” to enter the following screen.

6.2.1 Table Area

The table area lists all analyzed samples, including basic sample information like

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 Reviewing Results

sample ID, sample status and so on.

 The table area displays the latest sample results at the top.

6.2.2 Graph Review

Enter “Test” to view the analysis results of samples.

6.2.3 Check/Cancle Check (for administrators only)

1) Check sample data

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 Reviewing Results

Select one or more sample records on the table data screen, click “Check”, the

sample status of the record will be marked with “Checked”.

2) Cancel Check

Select one or more checked sample records at the table data screen, click

“Cancel Check”, the “Checked” will disappear.

6.2.4 Delete (for administrators only)

1) Select the sample record to be deleted in the table area.

2) Click “Delete”, the following dialog box will display.

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 Reviewing Results

3) Click “Yes” to delete the record, and the dialog box will be closed.

6.2.5 Edit Information

Click the desired sample result and it will be highlighted. Click the “Edit Info”

button and the following dialog box will display.

You may edit the sample and patient information, and click “OK” to save the

change. The information on the table review screen will be refreshed.

6.2.6 Edit Results

Click the desired sample result and it will be highlighted. Click the “Edit Result”

button and the following dialog box will display.

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 Reviewing Results

Modify the results and click “OK” to save the changes. The information on the

graph review screen will be refreshed.

6.2.7 Search

1) Click “Query”, the following dialog box will display

2) Enter search conditions into the edit boxes or select them from the pull-down

lists.

3) Click “OK” to start search, the results will be displayed in the table area.

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6.2.8 Print

Select sample records to be printed, and then click “Print” to print them. In the

table data interface, a “Printed” sign will be applied to each printed sample in the

sample status sector.

 In the sample status sector, “Checked” sign is prior to “Printed” sign.

6.2.9 Transmission

Transmit selected data

1) Select samples to be transmitted at the table data screen.

2) Click “Export”, the following dialog box will display.

3) Select the “Chosen record” or “All records”.

4) Click “OK” to start transmitting specified results to the data management

software.

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Chapter 7Quality Control

7.1 Introduction

Quality Control (QC) consists of strategies and procedures that measure the

precision and stability of the analyzer. The results imply the reliability of the sample

results.

QC involves measuring materials with known, stable characteristics at frequent

intervals. Analysis of the results with statistical methods allows the inference

that sample results are reliable. MR recommends you run the QC program daily

with normal level controls.

A new lot of controls should be analyzed in parallel with the current lot prior to

their expiration dates. This may be accomplished by running the new lot of controls

twice a day for five days using any empty QC files. The QC files calculate the mean,

standard deviation and coefficient of variation for each selected parameter. The

instrument-calculated means of these ten runs should be within the expected

ranges published by the manufacturer.

This analyzer provides 2 QC programs: L-J QC and X-B QC.

 All the samples, controls, calibrators, reagents, wastes and areas contacted

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 Quality Control

them are potentially biohazardous. Wear proper personal protective

equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures

when handling them and the contacted areas in the laboratory.

 Keep your clothes, hairs and hands away from the moving parts to avoid injury.

 The sample may spill from the uncapped collection tubes and cause biohazard.

Exercise caution to the uncapped collection tubes.

 The reagents are irritating to eyes, skin and mucosa. Wear proper personal

protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory

procedures when handling them and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with

plenty of clean water and seek medical attention immediately.

 Running QC sample with error present will lead to unreliable results. If errors

are reported during QC analysis, remove the errors first and then continue with

the analysis.

 Do not reuse disposable products such as collection tubes, test tubes, capillary

tubes and so on.

 Sample agglutination may result in inaccurate analysis results. Check the

control samples to see if there is any agglutination, if yes, process the samples

according to your laboratory’s protocols.

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 Use the controls and reagents specified by MR only. Store and use the

controls and reagents as instructed by their instructions for use.

 Refer to the instructions for use of the control for its use and storage.

 Be sure to mix any control sample that has been prepared for a while before

running it.

 Be sure to use the MR-specified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

7.2L-J QC

7.2.1Editing L-J QC Settings (for administrators

only)

Before running a new lot of controls, you must set up a QC file for each lot of

controls.

1) Click the menu option “QC” > “L-J QC” > “Setup”

2) Enter the L-J QC setup screen.

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3) Click “New”, or select a QC file without QC results, and then click “Edit”.

4) Enter the lot No. of the controls in the edit box manually.

 The lot No. shall not be empty and up to 16 digits can be entered. You can

enter characters, numbers, letters and special characters.

5) Select the control level.

6) Enter the expiration date of the lot.

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7) Select the control type.

8) Select the QC mode.

9) Set QC sample ID: if you are used to analyze control together with blood

samples, you can set a unique ID for the control. The analyzer will recognize the

sample as control when it reads the unique ID. After the analysis completes, the

results will be saved into the QC file of the QC sample ID.

10) Enter the target and limits in the edit boxes according to the package insert of

the lot of controls.

11) Click other icons to switch screen and save the QC information.

 Setting limits

You can adjust the format of limits according to the following procedure.

1) Click “Limit Setup”.

2) Click “Absolute value” to display the limits in the form of absolute value, or

click “Percentage” to display the limits in the form of percentage.

3) Click “OK” button to save the settings.

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7.2.2Running L-J QC

You can select one of the two ways below to run controls:

1) Run controls under the “QC” screen.

2) Put controls together with normal samples, and run the controls under the

sample analysis screen.

 From Way A

After editing the QC information, you can start QC analysis by whole blood or

prediluted according to the selected QC mode.

 When switching mode from “Prediluted” to “Whole Blood”, a progress bar

will be displayed while the analyzer runs mode switching sequence.

1) Click the menu option “QC” > “L-J QC” > “Count” to enter the QC count

screen.

 Be sure that the level of the control to be run is the same with the current QC

file, and the control is not expired.

 The expiration date of expired controls is displayed in red.

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2) Prepare the control as instructed by the instructions for use of the controls.

3) Run QC analysis.

4) When analysis finishes, the QC results will be displayed in the current screen

and be saved in the QC file automatically.

5) Do the above procedures to continue running QC analysis if necessary.

 Up to 100 QC results can be saved in each QC file.

 From Way B

After setting special “QC Sample ID” for a control under the QC setup screen, you

can put the control together with normal samples, and run it under the “Count”

screen.

When editing worklist or entering next sample information in the “Next Sample”

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 Quality Control

dialog box before daily analysis, enter the special “QC Sample ID” as “Sample ID”.

Based on the QC mode selected, you can choose to run QC analysis from whole

blood or prediluted.

 When switching mode from “Prediluted” to “Whole Blood”, a progress bar

will be displayed while the analyzer runs mode switching sequence.

1) Prepare the control as instructed by the instructions for use of the controls.

2) Refer to section 5.5.1 Sample Preparation for sample preparation under whole

blood and pre-diluted modes.

3) When it is ready to run a sample (i.e. the status icon and the analyzer indicator

is green), present the sample to the sample probe, and then press the aspirate

key to start QC analysis.

4) When you hear the beep, remove the control.

5) When analysis finishes, the QC results will be displayed in the current screen

and be saved in the QC file automatically.

6) Do the above procedures to continue running QC analysis if necessary.

 Up to 100 QC results can be saved in each QC file.

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 Quality Control

7.2.3Reviewing L-J QC Results

After QC analysis, you can review the QC results in the following ways.

1) QC Graph

2) QC Table

 L-J QC graph review

1) Click “QC Graph” button on the”Count” screen to enter the L-J QC graph

screen.

2) You can click the arrow buttons on the right of the graph to browse graphs of

the parameters. You can click the arrow buttons under the graph to browse all

the QC results.

3) Click the “Print” icon in the status bar to print information of the current QC

file and the QC graph of all parameters.

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 Quality Control

 The green vertical line and values of the corresponding QC points will not be

printed.

 L-J QC table review

1) Click “QC Table” button on the “Count” screen to enter the L-J QC table

screen.

2) You can click the arrow buttons on the right of the table to browse all QC

records. You can click the arrow buttons under the table to browse all the

parameter results.

3) You can click the “Print” icon in the status bar to print the QC table.

 Delete (for administrators only)

1) Click “Delete”, the following dialog box will display.

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 Quality Control

2) Click “Yes” to delete the selected records.

 The operation will be recorded in the system log.

 Transmission

To transmit QC data to external data management software or HIS/LIS/HIS, do as

follows.

1) Click “Comm.”, the following dialog box will display.

2) Select to transmit “Selected” or “All” records.

3) Click “OK” to start transmitting specified results to the data management

software.

 If auto-communication is enabled and a sample is run during the transmission

of the QC data, then only when the QC data transmission finished will the

auto-communication of the sample result start.

 The QC data saved in the process of transmission will not be transmitted.

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 Export

To export QC information and results of the current QC file, do as follows.

1) Insert an USB and then click “Export”.

2) The system will detect the USB and export data automatically.

3) The prompt “Export succeeded.” will display.

7.3X-B QC

7.3.1Introduction

The X-B analysis is a weighted moving average analysis that uses values obtained

from patient samples. It uses the 3 red cell indices, MCV, MCH and MCHC to

indicate the hematology instrument performance.

It is recommended the X-B analysis be activated when the sample volume of your

laboratory is greater than 100 samples per day. Effective use of X-B requires

randomization of samples and a normal cross section of patients to prevent

skewing of indices. It observes the trend of QC results in the reference range

formed by the specified target and limits.

The analyzer implements X-B QC on the 3 parameters: MCV, MCH and MCHC, each

group of samples for X-B analysis consists of 20-200 sample results obtained from

normal analysis of both whole blood and pre-diluted modes. The analyzer can save

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up to 500 X-B QC results. When the saved QC results have reached the maximum

number, the newest result will overwrite the oldest.

7.3.2Editing X-B QC Settings (for administrators

only)

1) Click the menu option “QC” > “X-B QC” > “Setup”.

2) Enter the X-B QC setup screen.

3) At the X-B QC setting screen, you may activate/deactivate X-B QC, set

target/limits, and configure the sample validity setup.

 Editing X-B QC settings

1) In the “Samples/Batch” edit box, you may enter the amount of samples

[within the range 20(default) to 200] to be included in calculating for an X-B QC

point.

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2) Activate/deactivate X-B QC. If X-B QC is activated, the samples meeting validity

requirements will be included in X-B QC.

 Setting target/limits

Before the X-B QC analysis, you shall set up the target and limit for each

parameter on the X-B QC setup screen.

 The units of target/limit of all parameters are the same as those in the

parameter unit setup screen.

1) In the “Target/Limit” area of the X-B QC setup screen, specify the targets and

limits in the “Target/Limit” table by entering manually.

 Do not leave any of the targets and limits for the QC parameters blank.

 When used for the first time, the default setting will provide the initial values

for the targets and limits of all QC parameters.

2) Click other icons to switch screen and save the settings.

 Setting sample validity

In X-B QC, sample results conforming to any of the following conditions will be

considered as invalid and cannot be used in the QC calculation.

1) Sample results exceeding the linearity range;

2) Background results;
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 Quality Control

3) Sample results not conforming to the “Sample Validity Setup”;

4) QC data for QC mode other than X-B (e.g. L-J);

5) Calibration data;

6) Results generated while there are errors which could affect the accuracy of the

results (e.g. insufficient aspiration volume or clogging).

“Sample Validity Setup” is to set up the ranges of valid RBC, MCV, MCH and

MCHC results. Only when the results of all these four parameters are within the

specified ranges, the sample results can be used for X-B QC calculation. Do as

follows to set the sample validity.

1) Select “On” to activate X-B QC. On the “Sample Validity Setup” of the X-B

QC setup screen, set the upper and lower limits of the 4 parameters in the

sample validity setup area. The default validity range of each parameter is

shown in the following figure.

2) Click “Yes” to save the setup.

 In the sample validity setup, the upper limit shall be no smaller than the lower

limit. Otherwise, there will be prompted message asking you to revise.

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 The valid ranges of the RBC parameters are their linearity ranges; the valid

ranges of other parameters are their display ranges.

 All the entries shall be numbers with only one decimal point. The length of the

number entered cannot be longer than the length of the text box.

 Once the validity range is changed, the previous results will not be used in the

QC calculation as valid results. For example, if 20 valid samples are needed for

the X-B QC calculation, when you change the validity range after 10 groups of

valid sample results have been acquired, these 10 groups of results will be

discarded, and only valid sample results generated afterwards will be used in

the QC calculation.

 The units of lower and upper limits of all parameters are the same as those in

the parameter unit setup screen. See section 9.2.4 Setup - Parameter Unit

Setup.

 Setting limits

You can adjust the format of limits according to the following procedure:

1) Click “Limit Setup”.

2) Click “Absolute value” to display the limits in the form of absolute value, or

click “Percentage” to display the limits in the form of percentage.

3) Click “OK” button to save the settings.

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 Quality Control

 Restore defaults

If you want to restore the default targets and limits of the parameter, click

“Defaults”. The default values of the target and limits of each parameter are as

follows:

Parameter Target Limits (#)

MCV 90 2.7

MCH 30 0.9

MCHC 340 10

7.3.3Running X-B QC

After editing X-B QC settings, the system will start X-B QC run automatically.

After every 20-200 results (determined by the setting) are obtained, the system will

perform the X-B calculation once automatically. You can review the result in X-B QC

graph or X-B QC table.

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7.3.4 Reviewing X-B QC Results

After QC analysis, you can review the QC results in the following ways.

1) QC Graph

2) QC Table

 X-B QC graph review

1) Click the menu option “QC” > “X-B QC” > “QC Graph”, the following screen

will display.

2) Select QC file No., the information of the file and the QC graph will be displayed

on the screen.

3) You can click the arrow buttons under the graph to browse all the QC results.

 X-B QC table review

1) On the X-B QC graph screen, click “QC Table” button to enter the X-B QC table

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screen.

2) You can click the arrow buttons on the right of the graph to browse all QC

records.

3) The delete, print and export operations can all be performed same as stated in

the L-J QC table review section.

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Chapter 8Calibration

8.1Introdution

Calibration is a procedure to standardize the analyzer by determining its deviation

under certain specified conditions. In order to get accurate sample analysis results,

you should calibrate the analyzer according to the procedure below when

necessary.

There are three calibration programs available on this analyzer: manual calibration,

auto calibration using calibrators and auto calibration using fresh blood samples.

All the parameters or part of the parameters of WBC, RBC, HGB, MCV and PLT can

be calibrated by the calibration programs.

 All the samples, controls, calibrators, reagents, wastes and areas contacted

them are potentially biohazardous. Wear proper personal protective

equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures

when handling them and the contacted areas in the laboratory.

 The reagents are irritating to eyes, skin and mucosa. Wear proper personal

protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory

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 Calibration

procedures when handling them and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with

plenty of clean water and seek medical attention immediately.

 Keep your clothes, hairs and hands away from the moving parts to avoid injury.

 Be sure to dispose of reagents, waste, samples, consumables, etc. according to

government regulations.

 Do not reuse disposable products such as collection tubes, test tubes, capillary

tubes and so on.

 Be sure to use the MR-specified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

 Calibration procedures can only be performed by users of the

administrator-level.

 Use the calibrators and reagents specified by MR only. Store and use the

calibrators and reagents as instructed by their instructions for use.

 The analyzer identifies a sample as a calibration sample only if the analysis is

started from the “Calibration” screen.

 Calculation of reproducibility is included in the calibration procedure.

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 Calibration

8.2When to Calibrate

The analyzer is calibrated at the factory just before shipment. It is electronically

stable and does not require frequent recalibration if you operate and maintain it as

instructed by this manual. You only need to recalibrate this analyzer if.

1) you are going to use this analyzer for the first time (usually done by a

Genrui-authorized representative when installing the analyzer).

2) an analytical component has been changed.

3) you are going to re-use the analyzer after a long-term storage.

4) the quality control results indicate there may be a problem.

5) use environment changes significantly.

 All of the measured parameters must be calibrated before readings of the

analyzer can be used as valid analysis results.

8.3 How to Calibrate

8.3.1Preparing Your Analyzer

Do the following pre-calibration procedures before calibration. If problems are

detected during these checks, do not attempt to calibrate the analyzer. If

necessary, contact MR customer service department or your local

distributor for assistance.

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 Calibration

1) Check and make sure enough reagents have been prepared for the calibration.

You need to start over the calibration if the reagents run out during the process.

2) Check the background (for calibration right after startup) or blank count results.

If the analyzer alarms for abnormal background results, see Chapter 11

Troubleshooting for solutions. (See Appendix B Specifications for the

background range.)

3) Run a vial of normal control consecutively for 10 times under Whole Blood

-CBC+DIFF mode. Enter the review screen to check the reproducibility of the

results and make sure they meet the following requirements.

Param Whole Blood Prediluted

Range
-eter Precision (CV) Precision(CV)

WBC 3.5×109/L～15.0×109/L ≤ 2.0% ≤4.0%

RBC 3.00×1012/L ~ 6.00×1012/L ≤ 1.5% ≤3.0%

HGB 100 g/L ~ 180 g/L ≤ 1.5% ≤3.0%

MCV 70 fL～120 fL ≤ 1.0% ≤2.0%

100×109/L ~ 149×109/L ≤ 6.0% ≤10.0%

PLT
150×109/L ~ 500×109/L ≤4.0% ≤8.0%

4) It is recommended that you create a log table for your analyzer. This log table

should contain all necessary information that is pertinent to your analyzer.

Suggested items that you may want to include in the log table are: calibration

date, supplier of calibrator, lot number, expected results and limits, and result of
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 Calibration

background check.

 Be sure to use the evacuated collection tubes recommended in the Appendix.

 If fresh blood sample is used for reproducibility test, make sure the sample

volume is enough to support the test.

8.3.2 Manual Calibration

Click the menu option “Calibration” > “Manual” to enter the following screen.

 If you log in at the operator access level, you can only view the calibration

factors. To perform calibration, please log out and then log in at the

administrator access level.

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 Calibration

Do as follows to calibrate the analyzer.

1) At the “Manual” calibration screen, check the calibration factors and calculate

the new factors according to the following equation:

Old factor × Reference value

New factor =
caculated mean value

For example: Suppose the WBC reference value of a calibrator is 8.4, and the

current calibration factor of the whole blood mode is 98.90%.

Run the calibrator under the whole blood mode for 11 consecutive times and

take the WBC results of the 2nd to 11th runs to calculate: 8.1, 8.0, 8.1, 8.1, 8.3,

8.3, 8.2, 8.0, 8.1, 8.3. The obtained CV is 1.5% and the mean value is 8.16, which

meet the requirements.

The new calibration factor is obtained.

. %× .
New factor= .
= 101.81%

The calculated calibration factors shall be between 75.00% ~ 125.00%. In case

of an invalid calibration factor, try to find out the reason (e.g. calibration

material not thoroughly mixed, misoperation, etc.). Then recalibrate the

analyzer and recalculate the calibration factors.

2) Enter the new calibration factors into the factor cell of the parameter that

requires calibration.

3) When you switch screen after entering the new calibration factor, a prompt will

display.

a) If the entered calibration factors are valid, a dialog box will pop up asking

you to save the new factor when you are exiting the screen. And the

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calibration date of the corresponding parameter changes to the current

system date.

b) If the entered calibration factors are invalid, a dialog box will pop up

prompting “Invalid entry” when you are switching to another screen. The

new calibration factor will not be saved, and the calibration date will not be

refreshed.

4) Print

Click “Print” to print the current calibration factor.

If the calibration factors are invalid, you will not be able to print them and the

dialog box “New calibration factor is invalid.” will display.

If the calibration factors are valid but not saved, a dialog box will display asking

you to save the factors. Click “Yes” to save and print the factors. Or click “No”

to cancel the operation without saving or printing them.

8.3.3 Calibration with Calibrator

Click the menu option “Calibration” > “Calibrator” to enter the following screen.

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 Calibration

 The calibrator calibration can be performed under Whole Blood and Prediluted

mode.

 Only MR-specified calibrators shall be used. MR will not be responsible

for any erroneous result caused by using other calibrators.

 See the instruction for use of the calibrators for the lot No., expiration date and

the target.

 The out-of-range CV% does not influence the display of calibration factors.

Do as follows to calibrate the analyzer with calibrators.

1) Check the mode on the analyzer screen.

2) Enter the lot No. of the calibrator into the “Lot No.” box.

3) Enter the “Exp. Date”. The entered expiration date should be either the

expiration date printed on the labeling or the open-container expiration date,

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 Calibration

whichever is earlier. The open-container expiration date is calculated as follows:

the date that container is opened + the open-container stability days.

4) Enter the targets into the “Target” cells.

5) Prepare the calibrator as instructed by instructions for use of the calibrators.

6) Press the aspirate key to start calibration.

7) After the analysis, the analyzer will have different responses to different analysis

results.

When the current running is done, if there is a parameter whose calibration

data is out of its linearity range but still within the display range, then the

calibration data will be displayed in the list and a message box will also pop up.

Click “OK” to close the message box, and the data will be deleted from the

table without saving automatically.

When the running is done, if there is a parameter whose calibration data is out

of the display range, then the non-numeric parameter values “***” will be

displayed in the list and a message box will pop up.

Click “OK” to close the message box, and the data will be deleted from the

table without saving automatically.

The valid results within the linearity range will be displayed directly.

Valid calibration results will be marked with “√” per the default setting, and

will be taken to calculate calibration factors.

8) If the calibration factors have not been calculated but you switch to another

screen, then a message box will pop up.

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 Calibration

Click “Yes” to switch to another screen while discarding the calibration data

and closing the message box. The original calibration factors remain.

9) When calibration count has been performed to a sample for n times (n≥5), the

analyzer will calculate the Mean, CV% and calibration factors of all the

calibration data marked with “√” (calibration data of the first run is not

marked with “√”, so it is not included in the calculation).

You can select several data to calculate the calibration factors, but only after at

least 5 groups of the data are marked with “√” can you get the calibration

factors. The calibration factors will be refreshed whenever you select “√” or

deselect “√”.

When the amount of valid calibration data in the list reaches 10, a message box

“Calibration is completed.” will pop up. Then, if you press the aspirate key

again, the analyzer will beep without starting analysis.

10) There may be two cases when you are switching to another screen:

If the calibration factors of any parameter is out of the range of 75%-125% or

the CV% of any parameter exceeds the reproducibility range, then the

calculated calibration factors of all parameters will not be saved and a message

box will also pop up.

Click “Yes” to close the dialog box and switch to another screen. The

calibration factors and dates of all parameters will not be changed.

If the calculated calibration factors of all parameter are within the range of

75%-125% and the CV% of all parameter are also within the reproducibility

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 Calibration

range, then a message box “Save new calibration factor?” will pop up. Click

“Yes” to save the new calibration factors while closing the message box and

switching to another screen.

11) Print

If the calibration factors are invalid, click “Print”, the dialog box “New

calibration factor is invalid.” will display.

If the calibration factors are valid but not saved, click “Print”, a dialog box

“Save new calibration factor?” will display asking you to save the factors. Click

“Yes” to close the dialog box, save and print the calibration results. Or click

“No” to cancel the operation without saving or printing them.

8.3.4 Calibration with Fresh Blood

Click the menu option “Calibration” > “Fresh Blood” to enter the following

screen.

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 Calibration

Do as follows to calibrate the analyzer with fresh blood.

1) Prepare 3 to 5 normal fresh blood samples as instructed by 5.5.1 Sample

Preparation.

2) Run each of the prepared samples on the reference instrument (or by the

reference method) five times at least. Calculate the mean values and use them

as the targets. Or perform measurement and calculation according to the

reference method and take the calculated data as the targets.

3) Select mode for fresh blood calibration, which can be Whole Blood or

Prediluted.

4) Select the ID of current sample from the pull-down box “Current Sample ID”.

5) Select the parameter needed to be calibrated in the first line of the check box.

6) Enter the targets into the “Target” cells.

7) Prepare fresh blood sample.

8) Press the aspirate key to start calibration.

9) After the analysis, the analyzer will have different responses to different

analysis results.

10) When calibration count has been performed to a sample for n times (n≥5), the

analyzer will calculate the Mean, CV% and calibration factors of all the

calibration data marked with “√” automatically.

You can select several data to calculate the calibration factors, but only after at

least 5 groups of the data are marked with “√” can you get the calibration

factors. The calibration factors will be refreshed whenever you select “√” or

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 Calibration

deselect “√”.

When the amount of valid calibration data in the list reaches 10, a message box

will pop up when you start calibration again.

11) Select other calibration sample ID from the “Current Sample ID” pull-down

box and analyze other samples according to Step 8-9 above to obtain the

calibration factors of all samples.

12) There may be several cases when switching to another blood sample:

13) After calibration factors of at least 3 fresh blood samples are obtained, click the

“Calculate” button to enter the screen of calibration calculation.

Select or deselect the calibration factors of a blood sample for the calculation

of the mean calibration factors by clicking the check boxes before the

calibration factors.

When 3 or more groups of calibration factors are checked, CV% will be

re-calculated automatically base on the checked calibration factors.

When 3 or more groups of calibration factors are checked, the mean calibration

factor will be re-calculated automatically base on the checked calibration

factors. The mean calibration factors are regarded as invalid if the deviation of

absolute value between the calibration factors included in calculating the mean

and the original calibration factors reaches or exceeds 5%.

14) If the mean calibration factors have not been calculated, when you exit the

fresh blood screen or switch to another calibration mode, a dialog box will pop

up.

8-13
 Calibration

Click “Yes” to discard the calibration data, close the dialog box, and switch to

another screen or calibration mode. The original calibration factors and date

remain the same.

15) If the calculated mean calibration factors are valid, when exiting the fresh blood

calibration screen or switching to another calibration mode, a dialog box will

pop up.

Click “Yes” to save the current mean calibration factors. Then, you can switch

to another screen or calibration mode. Click “No” to close the dialog box and

switch to another screen or calibration mode without saving the mean

calibration factors and all the calibration data.

16) Print

If the mean calibration factors are invalid, click “Print”, the dialog box

“Calibration factor is invalid.” will display.

If the mean calibration factors are valid, you can click “Print” to print the

calibration factors of a group (or more) of blood samples in table form, no

matter whether they are selected (“√”) or not. The results obtained in the

calibration process and the mean calibration factors can also be printed.

8-14
 Settings

Chapter 9Settings

9.1Introduction

The analyzer is a flexible laboratory instrument that can be tailed to your working

environment. You can use the “Setup” menu to customize the software options as

introduced in this chapter.

For the security of the settings and data, two access levels are provided to the

operator of the analyzer. The administrator access level provides the operator with

access to more functions or settings, some of which can be configured to be

accessible to operators.

See the following figure for the setup menu.

9-1
 Settings

9.2 Setting Up the Analyzer

9.2.1 System Setup

1) Date/Time Setup

Click “Setup” > “System Setup” > “Date/Time Setup” in the menu to enter

the following screen. You can set up the date, time and date format of the analyzer

on the screen.

2) Print Setup

Click “Setup” > “System Setup” > “Print Setup” in the menu to enter the

following screen. You can set up the following contents:

a) Print type

b) Print format

c) Auto print

d) Print title

9-2
 Settings

3) Print type

There are 2 types of printing device available: Printer and Recorder. You can

select either of them from the pull-down list.

4) Print format

You can select “ Print with histogram” or “Print without histogram”.

5) Auto print

Select “On” or “Off”.

6) Print title

Input the printing title.

7) Communication

Click “Setup” > “System Setup” > “Communication” in the menu to enter

the following screen. You can set up the Communication port and Transmission

setting.

9-3
 Settings

8) Communication port setup

Click the “Local IP”, “Server IP” , "Local Mask” and “Local Gateway” edit

boxes to enter the contents.

9) Transmission setting

Select the communication protocol type from the pull-down list.

10) Auto transmission

Click the pull-down list to select “On” or “Off”.

11) Transmission mode of histogram and scattergram

Click the pull-down list to select “ Yes” or “No” to decide to transmis the

histogram and scattergram.

9.2.2User Administration

Click “Setup” > “User Administration” in the menu to enter the following screen.

9-4
 Settings

1) Modify password

You can modify your own password.

a) Select the current user, and then click “Modify Password”, the following

dialog box will display.

b) Enter the required information in the edit boxes.

c) Click “OK” to save the change and close the dialog box.

9-5
 Settings

 The password cannot be null, and 12 characters can be entered at most.

2) Creat new user

a) Click “Add”, the following dialog box will display.

b) Enter the “User Name”, “Name” and “Password” information.

c) Select user group of the user.

d) Click “OK” to save the change and close the dialog box.

 The user name cannot be null, and 12 characters can be entered at most.

 The name cannot be null, and 20 characters can be entered at most.

 The password cannot be null, and 12 characters can be entered at most.

3) Delete user

Select a user and then click “Delete” to delete it.

9-6
 Settings

 The current login user cannot be deleted.

9.2.3 Parameter Setup

1) Parameter Unit Setup

Click “Setup” > “Parameter Setup” > “Parameter Unit Setup” in the menu to

enter the following screen. You can set up parameter unit on this screen.

2) Select unit system

Click the “Unit System” pull-down list to select the unit system.

3) Reference Range Setup

Click “Setup” > “Parameter Setup” > “Ref. Range Setup” in the menu to

enter the following screen.

9 factory reference groups and 3 customized reference groups are provided for

9-7
 Settings

your choice. Each laboratory shall select a proper reference range of its own

based on its patient demographics. The reference range differs among races,

genders, ages and geographic locations.

4) Customizing reference groups

In the Group setup screen, input the parameters directly to set up the name,

lower and upper limits of age and parameter range.

5) Setting as default reference group

Click “Group” enter below screen, then select one of the reference group.

Click “OK”, the selected reference group can be restored to the default

settings.

9-8
 Settings

 The name, lower and upper limits of age and gender of the factory reference

groups cannot be modified.

 The input range of age is [0,999].

6) Modify reference range

To modify the reference range of a reference group, enter the cells of upper

and lower limits in the table.To restore the reference ranges to default, you can

click the “Default” button.

9.2.4Maintenance Setup (for administrators only)

Click “Setup” > “Maintenance Setup” in the menu to enter the following screen.

You can set up the following content.

9-9
 Settings

1) Auto Blank

Select “On” to save the setting if you need to do one time blank test at each

time’s startup.

2) Auto Clean

There are 30times, 50times, 75times, 100times, 125times and 150times to be

selected. If you select 50times, the machine will process auto clean when test

number is up to 50 samples. If test samples have not been up to 50times, it will

switch off, then recount after start up.

3) Diluent Reminder

If you need the reminder of counting function in prediluent mode, you can

select “On”. Then a pop-up dialog will appear every time to remind you if

you want to count after setup.

4) Auto Sleep

If there is no operation during an interval time, the machine will go to sleep

automatically. You can also setup the sleeping time according to your need.
9-10
 Service

Chapter 10Service

10.1 Introduction

Preventive and corrective maintenance procedures are required to keep the

analyzer in a good operating condition. This analyzer provides multiple

maintenance functions for this purpose.

This chapter introduces how to use the provided functions to maintain and

troubleshoot your analyzer.

 All the analyzer components and surfaces are potentially infectious, take

proper protective measures for operation or maintenance.

 The reagents are irritating to eyes, skin and airway. Wear proper personal

protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory

procedures when handling them and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with

plenty of clean water and seek medical attention immediately.

 Improper maintenance may damage the analyzer. Operators must follow the

10-1
 Service

instruction of this manual to perform maintenance operations.

 For any questions, contact MR customer service department.

 Only MR-supplied parts can be used for maintenance. For any questions,

contact MR customer service department.

 Avoid contact with the sharp sample probe when performing maintenance.

The following table lists the tools that may be used in maintenance.

No. Tools

1 Cross-headed screwdriver

2 Slotted head screwdriver

3 Medical gloves

4 Alcohol

10.2 Maintaining Your Analyzer

Maintenance options of the analyzer includes: maintenance, cleaning and fluidics

maintenance.

10-2
 Service

10.2.1Change Lyse, Change Diluent, Change Sheath

Click the above button can do the replacement.

You can change Lyse under below condition:

1) There are bubbles in reagent tube.

2) Reagent was polluted.

3) Reagent was run off.

Changing reagents procedures are:

1) Click “ Change Lyse”/“Change Diluent”/“Change Sheath”.

2) When all buttons appear to grey, the process will go on.

3) The buttons will go normal once replacement is done.

10-3
 Service

10.2.2Flush aperture

Unclogging includes zapping and flushing the aperture. When clog error is

reported, you should unclog the aperture.

The unclogging procedures are:

1) Click the “Flush aperture” button to start unclogging.

2) Do the above procedures to continue unclogging aperture if necessary. If the

error persists, perform probe cleanser maintenance of the related channels.

10.2.3 Pack up

If the analyzer is not to be used for over 2 weeks or before shipment, you should

perform this procedure.

Do as follows to pack up:

1) Take out all the tube connectors from the machine back side.

2) Seperately store the reagent tubes and the remained reagents well, keep them

away from dust.

3) Click “Prepare shipping”, click “Yes” to perform the pack up procedure

after the dialog pop up.

4) The machine start packing up.

5) Return to the Maintenance screen after pack up.

 This software can still be used after the pack up.

10-4
 Service

10.3Viewing Logs

Click “Maintenance” > “Log” in the menu to enter the following screen.

You may view the error information, parameter modification information and

records of daily operation in the log.

The “Log” screen records all activities of the analyzer. It contributes significantly

to searching for operation history and troubleshooting the analyzer.

 The oldest record will be overwritten automatically when number of log

records reaches the utmost.

 Records of two years can be stored at most.

 Exporting logs

1) Click “Export”, the following dialog box will display.

10-5
 Service

2) Select the range of the logs that you want to export.

3) Click “OK” to close the dialog box and export the logs.

10.4 Version Info.

Click “Setup” > “System Setup” > “Version” in the menu to enter the following

screen.

You may view the current version information of the analyzer.

10-6
 Troubleshooting

Chapter 11Troubleshooting

11.1 Introduction

This chapter contains information that is helpful in locating and correcting

problems that may occur during operation of your analyzer.

 This chapter is not a complete service manual and is limited to problems that

are readily diagnosed and/or corrected by the user of the analyzer.

11.2 Error Information and Handling

During the operation, if error(s) is detected, the analyzer will beep and display the

corresponding error message in the error information area at the bottom right of

the screen. Meanwhile, the indicator will turn red.

The following figure is the error information dialog box.

11-1
 Troubleshooting

The name and troubleshooting method of the errors are displayed. Names of the

errors are displayed by the order of their occurrence.

You may click to select the error, and view its troubleshooting information in the

error help box. The troubleshooting information of the first error is displayed by

default. Please follow the error help to resolve the error by sequence.

The following functions are provided:

1) Remove error

Click the “Remove Error” button to clear all the errors that can be removed

automatically. For the errors that cannot be removed automatically, follow the

troubleshooting method to solve them.

2) Close the error information dialog box

Click “Close” to close the dialog box, but the errors will still be displayed in

the error information area on the screen. Click the error information area again,

the dialog box will be displayed.

The possible error(s) and the corresponding troubleshooting information are

listed below.

Error Name Possible Causes Actions

 Check whether there is diluent in

Diluent ran out Diluent ran out
the diluent container.

11-2
 Troubleshooting

Error Name Possible Causes Actions

 If there is no diluent, replace with a

new bucket of diluent. Click

“Maint.”>“Change Diluent” to

clear the error automatically.

 If the error still exists after replacing

the diluent, contact our customer

service department.

 Check whether there is lyse in the

reagent container.

 If there is no lyse, replace with a

new bucket of lyse. Click “Maint.”>

Lyse ran out / lyse tube
Lyse ran out “Change Lyse” to clear the error
was clogged
automatically.

 If the error still exists after replacing

the lyse, contact our customer

service department.

 Check whether there is sheath in

Sheath ran out Sheath ran out the reagent container.

 If there is no sheath, replace with a

11-3
 Troubleshooting

Error Name Possible Causes Actions

new bucket of sheath. Click

“Maint.”>“Change Sheath” to

clear the error automatically.

 If the error still exists after replacing

the sheath, contact our customer

service department.

 Check the waste container Is full or

not.
Waste container full
Waste  Check the sensor connector is short
/waste sensor is
container full circuit or not.
broken
 If the error still exists, contact our

customer service department.

 Check whether the reagent was

polluted or out of valid date.

Reagent or reagent  Click “Maint.”>“Rinse impedance

Blank test
tube were polluted or channel” to clean the tube
failed
out of valid date etc
 If the error still exists, click “ Soak

impedance transducer” , then do

blank test again to confirm the error

11-4
 Troubleshooting

Error Name Possible Causes Actions

is clear or not.

 If the error still exists after replacing

the cleanser, contact our customer

service department.

 Check “HGB blank voltage result”

in “ System status detection ”

screen.

HGB result HGB blank voltage  If “HGB blank voltage” is beyond

inaccurate abnormal the reference range, contact our

customer service department,

readjust “ HGB background

voltage” under our instruction.

 Click “Maint.” > “Flush Aperture”,

then do a blank test counting to

Aperture clogging or
WBC clogging check the counting time.
WBC counting time
or RBC  If the erros still exists, click
wrongly setup or
clogging “ Maint. ” > “ Soak impedance
valves default
transducer” to aspirate the probe

cleanser to soak the aperture.

11-5
 Troubleshooting

Error Name Possible Causes Actions

 If the error still exists, contact our

customer service department.

 Check the power cable is well

 Power cable is connected or not.

disconnected with  Check the power fuse is burned or

Startup no
the power outlet not.
response
 Power fuse was  If the error still exists, please switch

maybe burned out off , then contact our customer

service department.

 Poor connection

of motor signal

cable

Motor
 Trip optocoupler Switch off the power, then contact our
abnormal
fault customer service department.
sound
 Motor failure

 Motor drive

circuit failure

Printer no  Cable  Check the printer power cable and

response  Printer failure connection cable, if it still cannot be

11-6
 Troubleshooting

Error Name Possible Causes Actions

printed, re-plug the connection

cable and restart the machine and

printer.

 If the error still exists, connect the

printer to a normal PC to check if it

can work or not.

 If the error still exists, contact our

customer service department.

If there is any other error(s), the processing method should be based on the

software prompt.

11-7
 Specifications

Appendix ASpecifications

A.1 Classification

According to the 98/79/EC, the analyzer belongs to in vitro diagnostic medical

device. It was classified into Others device, not in annex II and not for self-testing,

not for performance evaluation.

A.2 Reagents

Diluent HA 5D 01 Diluent

Lyse HA 5S 02 Lyse

Sheath HA 5L 03 Sheath

/ Probe cleanser

A.3 Applicable Tubes

The following tubes can be used:

1) Ф12~15×75mm evacuated collection tube (without cap) for whole blood

mode.

2) Ф11×40mm (1.5ml centrifugal tube) and 0.5ml centrifugal tube for predilute

and capillary whole blood mode.

A-1
 Specifications

B.4 Parameters

Abbreviatio Defaul
Parameter Name
n t Unit

White Blood Cell count WBC 109 / L

Basophils number Baso# 109 /L

Basophils percentage Baso% %

Neutrophils number Neu# 109 /L

Neutrophils percentage Neu% %

Eosinophils number Eos# 109 /L

Eosinophils percentage Eos% %

Lymphocytes number Lym# 109 /L

Lymphocytes percentage Lym% %

Monocytes number Mon# 109 /L

Monocytes percentage Mon% %

Red Blood Cell count RBC 1012/ L

Hemoglobin Concentration HGB g/L

Mean Corpuscular Volume MCV fL

Mean Corpuscular Hemoglobin MCH pg

Mean Corpuscular Hemoglobin Concentration MCHC g/L

A-2
 Specifications

Abbreviatio Defaul
Parameter Name
n t Unit

Red Blood Cell Distribution Width - Coefficient of Variation RDW-CV %

Red Blood Cell Distribution Width - Standard Deviation RDW-SD fL

Hematocrit HCT %

Platelet count PLT 109 / L

Mean Platelet Volume MPV fL

Platelet Distribution Width PDW None

Plateletcrit PCT %

Platelet larger cell ratio P_LCC 109 / L

Platelet larger cell count P_LCC %

RBC
Red Blood Cell Histogram None
Histogram

PLT
Platelet Histogram None
Histogram

Size
Size Scattergram None
Scattergram

Diff
Differential Scattergram None
Scattergram

A-3
 Specifications

A.5 Sampling Features

A.5.1 Sample Volumes Required for Each Analysis

Refers to all terms present in the calibration curve expression with the exception of

concentration and reactivity.

Whole blood and capillary whole

≤28μL under both CBC and CBC+DIFF modes
blood mode

Prediluted mode ≤20μL under both CBC and CBC+DIFF modes

A.5.2 Throughput

CBC and CBC+5DIFF mode 60 samples/hour

CBC+5Diff + RRBC mode 40 samples/hour

A.6Performance Indicators

A.6.1Display Range

Parameter Display Range

WBC 0.00×109/L～999.99×109/L

RBC 0.00×1012/L～18.00×1012/L

HGB 0 g/L～300g/L

PLT 0×109/L～9999×109/L

HCT 0%~80%

A-4
 Specifications

A.6.2 Background/Blank Count

Parameter Background/Blank Count Requirements

WBC ≤ 0.2×109 / L

RBC ≤ 0.02×1012/ L

HGB ≤1g/L

PLT ≤ 10×109 / L

A.6.3 Linearity Range

Param Deviation Range Linearly Dependent

Linearity Range
eter (Whole Blood) Coefficientr

0.0×109/L～10.0×109/L ≤±0.3×109/L
WBC ≥0.990
10.1×109/L～100.0×109/L ≤±5％

0.10×1012/L～1.00
≤±0.05×1012/L
×1012/L
RBC ≥0.990
1.01×1012/L～8.00
≤±5％
×1012/L

0 g/L～70g/L ≤±2g/L
HGB ≥0.990
71 g/L～250 g/L ≤±2％

0×109/L～100×109/L ≤±10×109/L
PLT ≥0.990
101×109/L～1000×109/L ≤±8％

A-5
 Specifications

A.6.4Accuracy

Parameter Detection Range Relative deviation/%

WBC 3.5×109 /L～9.5×109 /L ≤±5.0

RBC 3.8×1012 /L～5.8×1012 /L ≤±2.0

HGB 115 g/L～175 g/L ≤±2.0

PLT 125×109 /L～350×109 /L ≤±8.0

HCT 35%～50% ≤±3.0

MCV 82 fL～100 fL ≤±3.0

A.6.5Precision

Whole Blood Precision

Parameter Detection Range
(CV/absolute deviation d)

WBC 3.5×109/L～15.0×109 / L ≤2.0%

RBC 3.00×1012 / L ~ 6.00×1012 / L ≤1.5%

HGB 100 g/L ~ 180 g/L ≤1.5%

100×109 / L ~ 149×109 / L ≤6.0%

PLT
150×109 / L ~ 500×109 / L ≤4.0%

HCT 35%～50% ≤2.0%

MCV 70 fL～120 fL ≤1.0%

A-6
 Specifications

A.6.6 Carryover

Parameter Deviation Requirements

WBC ≤0.5％

RBC ≤0.5％

HGB ≤0.6％

PLT ≤1.0％

A.7 Input/Output Device

 Be sure to use the specified devices only.

 If the analyzer is to be connected with LIS, the PC must be configured with dual

network cards.

A.7.1 External Computer (Optional)

Recommended PC configurations: CPU Intel® 1.6GHz and above

RAM: 1G or above

Hard disk: 160GB or above

Recommended resolution of the display: 1280*1024 (standard), 1680*1050 (wide

screen) Operating system: Microsoft Windows 7 or above, with DVD-ROM.

A-7
 Specifications

A.7.2. Keyboard (Optional)

101-Key alpha-numeric keyboard

A.7.3. Mouse (Optional)

A.7.4. External Barcode Scanner (Optional)

A.7.5. Printer (Optional)

A.8 Interfaces

4 USB ports and one network port.

A.9 Power Supply

Voltage Input power Frequency

Analyzer (100-240V～) ±10% 100-120VA (50Hz/60Hz)±1Hz

A.10Fuse

 Be sure to use the specified fuse only.

Fuse specification: 250VT3.15AH

A.11EMC Description

Do not use this device in close proximity to sources of strong electromagnetic

A-8
 Specifications

radiation (e.g. unshielded intentional RF sources), as these may interfere with the

proper operation.

This equipment complies with the emission and immunity requirements of the EN

61326-1:2013 and EN 61326-2-6:2013.

This equipment has been designed and tested to CISPR 11 Class A. In a domestic

environment it may cause radio interference, in which case, you may need to take

measures to mitigate the interference.

 It is the manufacturer’s responsibility to provide equipment electromagnetic

compatibility information to the customer or user.

 It is the user’s responsibility to ensure that a compatible electromagnetic

environment for the equipment can be maintained in order that the device will

perform as intended.

A.12 Sound Pressure

Maximal sound:65 dBA

 Be sure to use and store the analyzer in the specified environment.

A.13 Operating Environment

Optimal operating temperature: 10℃～35℃

A-9
 Specifications

Optimal operating humidity: 20%～85%

Atmospheric pressure: 70kPa～106kPa

A.14Storage Environment

Ambient temperature: -20℃～40℃

Relative humidity: 10%～90%

Atmospheric pressure: 50kPa～106kPa

A.15Running Environment

Ambient temperature: 10℃～35℃

Relative humidity: 20%～85%

Atmospheric pressure: 70kPa～106kPa

A-10
 Specifications

A.16Dimensions and Weight

Width(mm) ≤ 330

Height (mm) ≤ 400 (without foot)

Dimensions
Height (mm) ≤ 430 (with foot)

Depth (mm) ≤ 510

Weight ≤ 25Kg (Net weight)

A.17Safety Classification

Overvoltage category: II

Pollution degree: 2

Means of protection: Class I

A-11
 Hazardous Substances

Appendix BHazardous Substances

Hazardous substances
Parts name
Pb Hg Cd Cr(VI) PBB PBDE

shell 〇 〇 〇 〇 〇 〇

PCBA ×(1) 〇 〇 〇 〇 〇

sheet metal
〇 〇 〇 〇 〇 〇
parts
machining
〇 〇 〇 〇 〇 〇
part
Host plastic
〇 〇 〇 〇 〇 〇
pieces
metal
〇 〇 〇 〇 〇 〇
pieces
connection
〇 〇 〇 〇 〇 〇
cable
fluid path
component 〇 〇 〇 〇 〇 〇
s

Labels 〇 〇 〇 〇 〇 〇

Closure
〇 〇 〇 〇 〇 〇
Accesso assembly
ries Maintenan
〇 〇 〇 〇 〇 〇
ce tools
Probe wipe
〇 〇 〇 〇 〇 〇
block
Packaging
Package 〇 〇 〇 〇 〇 〇
materials

B-1
 Hazardous Substances

〇: means the content of the hazardous substance in all homogeneous

materials of the part is in the limited requirement according to the

standard of SJ/T 11363-2006.

×: means the content of the hazardous substance in at least one of the

homogeneous materials of the part is beyond the limited requirement

according to the standard of SJ/T 11363-2006.

1）some parts of the circuit board used lead solder during processing.

Notice: the product marked with “×” is because there has no other

technologies or parts to be replaced at present stage, under normal use

conditions, leak and mutation will not occur in 5 years, and it will not

cause environment pollution or harm to people and property.

B-2
MR International Healthcare Technology Co.,Ltd.

Room 1501,Grand Millennium Plaza,181 Queen’s Road Central,HK

Tel: +852 21581807

Fax: +852 30116829

Web: www.mr-healthcare.com