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LW D6500

Five-differential Hematology Analyzer


User’s Manual
Copyright

©Shenzhen Landwind Industry Co., Ltd. All rights reserved. This manual and its contents

represent special and confidential information of Shenzhen Landwind Industry Co., Ltd

(Landwind Company below). Without written permission from Landwind Company, any

individual or organization cannot reprint, copy, modify or publish all or part of the information

to others or spread the content. The readers of this manual are the users. They are authorized to

use this manual as part of purchasing the equipment of Landwind Company. Unauthorized

individuals are strictly forbidden to use this manual.

Landwind Company doesn't guarantee this information in any way, including (and yet not

limited to) the implicit warranties of business and rationality using for special purposes.

Landwind Company has take measures to make sure that this documentation is correct.

However, Landwind Company won't be responsible for errors or omissions, and reserves the

right to improve any product so as to enhance the reliability, function or design of the product.

Trademark

TM
, and are the trademarks of Landwind Company. The product

names of non-Landwind Company may be the trademarks of corresponding owners.

Declaration

The version of this manual is A/1 and the releasing date is 2013-2. This manual may be made

appropriate modifications without notification in advance.

Shenzhen Landwind Industry Co., Ltd reserves the right of the final say and explanation for this

instruction manual.
Preface
Thank you for purchasing Landwind's Five-differential Haematology Analyser. Here we express
our gratitude to you.

Please read this manual carefully so as to use the product properly. After reading it carefully,
please take care of it so you can refer to it when needed.

Product name: Five-differential Haematology Analyser

Model: LW D6500

Security classification: Anti-electric shock rate I, overvoltage category Ⅱ, pollution degree 2

Management category: The analyser belongs to the blood analysis system among the clinical
analytical instruments (6840). Its management category is II.

Production license number: Guangdong food and drug administration machine production
license No. 20020477

Registration certificate number: Guangdong food and drug administration machine (approved)
2012 No. 2400329

Product standard number: YZB/Guangdong 0116 - 2012 Five-differential Haematology


Analyser

Product composition: Composed of a blood sample absorption tube, dilution device, cleaning
device, analysing and measuring device, microprocessor, computer and monitor.

Scope of application: Its purpose is to count blood cells, five-differential white blood cells and
measure the concentration of haemoglobin in the clinical tests.

Manufacturer: Shenzhen Landwind Industry Co., Ltd.

Registered address: Room 408-413, Building E, Bijingyuan, Jingtian Road, Futian District,
Shenzhen

Production address: Zhuanchang Village, Langxin Neighbourhood Committee, Shiyan Street,


Baoan District, Shenzhen

Honglong Hi-Tech Park, Liyuan Industrial Region (Landwind Science and Technology Park)

I
Symbols

Symbols listed below apply to this manual.

Symbols Meanings

Refer to random file

Biological risk symbol

High pressure warning symbol

Laser warning symbol

High temperature warning symbol

Labels and silk screens

Labels and silk screens listed in the table below apply to this manual.

Symbols Meanings

Protective earthing symbol

Alternating current symbol

Only used in vitro diagnosis

Lot number

II
Expiry date

Serial number

Meter license mark

Production date

Avoid pricking hands

Manufacturer

Storage temperature

Refer to the operation manual

Tips for transportation

Network interface

This electronic information product contains


some poisonous and harmful substances. Its
environmental protection use period is 20 years.
Please rest assured while using it during this
period and don’t forget to recycle it when the
environmental protection use period ends.

Figure

III
All the figures provided in this operation manual represent illustrations or examples only. Please do not use
them for other purposes.

IV
Table of Content

Table of Content

Preface ........................................................................................................................................................ I

Chapter 1. Manual Overview .............................................................................................................. 1-1

1.1 Overview ..................................................................................................................................... 1-1

1.2 Application scope of the manual................................................................................................. 1-1

1.3 Manual Guide ............................................................................................................................. 1-1

1.4 Manual convention...................................................................................................................... 1-2

1.5 Security information ................................................................................................................... 1-2

Chapter 2. Installation ......................................................................................................................... 2-5

2.1 Overview ..................................................................................................................................... 2-5

2.2 Installation personnel .................................................................................................................. 2-5

2.3 Damage inspection ...................................................................................................................... 2-6

2.4 Installation requirements ............................................................................................................. 2-6

2.5 Opening the packaging ............................................................................................................... 2-8

2.6 System connections..................................................................................................................... 2-9

2.6.1 Electrical connections and reagent connections .......................................................... 2-9

2.6.2 Installation of diluent float sensor and replacement of reagent................................. 2-10

2.6.3 Installation of waste float sensor ............................................................................... 2-11

Chapter 3. System Overview ............................................................................................................... 3-1

3.1 Overview ..................................................................................................................................... 3-1

3.2 Scope of Application ................................................................................................................... 3-1

3.3 Structure of analysis unit ............................................................................................................ 3-3

3.3.1 Analyser ...................................................................................................................... 3-7

3.3.2 Power/status state light................................................................................................ 3-8

3.3.3 Power switch ............................................................................................................... 3-8

3.3.4 Counting button .......................................................................................................... 3-8

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Table of Content

3.3.5 Network interface........................................................................................................ 3-8

3.4 Operation interface...................................................................................................................... 3-8

3.4.1 Sample analysis ......................................................................................................... 3-11

3.5 Software operation .................................................................................................................... 3-14

3.5.1 Move the pointer ....................................................................................................... 3-14

3.5.2 Click .......................................................................................................................... 3-14

3.5.3 Double click .............................................................................................................. 3-14

3.5.4 Right click ................................................................................................................. 3-14

3.5.5 Drag the scroll bar ..................................................................................................... 3-15

3.5.6 Tab............................................................................................................................. 3-15

3.5.7 Button........................................................................................................................ 3-16

3.5.8 Check box ................................................................................................................. 3-18

3.5.9 Edit box ..................................................................................................................... 3-19

3.5.10 Information box ........................................................................................................ 3-19

3.5.11 Combo box ................................................................................................................ 3-20

3.5.12 Table.......................................................................................................................... 3-20

3.5.13 System Menu ............................................................................................................ 3-22

3.5.14 Directory tree ............................................................................................................ 3-23

3.5.15 Dialogue box ............................................................................................................. 3-24

3.5.16 Record switch bar ..................................................................................................... 3-24

3.6 Operation Help .......................................................................................................................... 3-25

3.6.1 Browse Help Information.......................................................................................... 3-25

3.6.2 Search Help Information ........................................................................................... 3-26

3.7 Reagents, controls and calibrators ............................................................................................ 3-27

3.7.1 Reagent ..................................................................................................................... 3-27

3.7.2 Controls and calibrators ............................................................................................ 3-28

Chapter 4. Operating Principle ........................................................................................................ 4-29

4.1 Overview ................................................................................................................................... 4-29

4.2 Absorb Sample .......................................................................................................................... 4-29

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Table of Content

4.3 Diluted Sample ......................................................................................................................... 4-29

4.3.1 Whole blood mode and micro-whole blood mode .................................................... 4-30

4.3.2 Predilution mode ....................................................................................................... 4-31

4.4 Leucocyte measurement............................................................................................................ 4-33

4.4.1 Laser flow cytometry ................................................................................................ 4-33

4.4.2 Electric impedance method principle ........................................................................ 4-34

4.4.3 Derivation of WBC-related parameters..................................................................... 4-35

4.5 Haemoglobin concentration measurement ................................................................................ 4-37

4.5.1 Colorimetric method ................................................................................................. 4-37

4.5.2 Haemoglobin concentration parameter ..................................................................... 4-37

4.6 RBC/PLT measurement ............................................................................................................ 4-37

4.6.1 Electric impedance method principle ........................................................................ 4-37

4.6.2 RBC parameters ........................................................................................................ 4-38

4.6.3 PLT parameters ......................................................................................................... 4-39

4.7 Cleaning .................................................................................................................................... 4-39

Chapter 5. Settings ............................................................................................................................. 5-40

5.1 Overview ................................................................................................................................... 5-40

5.2 Normal user level ...................................................................................................................... 5-40

5.2.1 General settings ......................................................................................................... 5-40

5.2.2 User and Password .................................................................................................... 5-45

5.2.3 Shortcuts ................................................................................................................... 5-47

5.3 Administrator Level .................................................................................................................. 5-47

5.3.1 General Settings ........................................................................................................ 5-47

5.3.2 User and Password .................................................................................................... 5-66

5.3.3 Shortcuts ................................................................................................................... 5-67

Chapter 6. Daily operations .............................................................................................................. 6-72

6.1 Overview ................................................................................................................................... 6-72

6.2 Preparation before the operation ............................................................................................... 6-73

6.3 Boot up and user login .............................................................................................................. 6-74

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Table of Content

6.4 Overview of worklist ................................................................................................................ 6-77

6.5 Daily QC ................................................................................................................................... 6-84

6.6 Preparation of samples .............................................................................................................. 6-84

6.6.1 Whole blood sample.................................................................................................. 6-84

6.6.2 Predilute sample ........................................................................................................ 6-85

6.7 Sample analysis ......................................................................................................................... 6-88

6.7.1 Enter worklist information ........................................................................................ 6-88

6.7.2 Steps of sample analysis ........................................................................................... 6-89

6.7.3 Handling analysis results .......................................................................................... 6-91

6.8 Shutdown .................................................................................................................................. 6-95

Chapter 7. Results review ................................................................................................................ 7-100

7.1 Overview ................................................................................................................................. 7-100

7.2 Graph review................................................................................................... 错误!未定义书签。

7.2.1 Sample/patient's information................................................................................... 7-101

7.2.2 Tab........................................................................................................................... 7-101

7.3 List review .............................................................................................................................. 7-108

7.3.1 Sample record ......................................................................................................... 7-109

7.3.2 Tab........................................................................................................................... 7-110

Chapter 8. QC ...................................................................................................................................... 8-1

8.1 Overview ..................................................................................................................................... 8-1

8.2 L-J QC......................................................................................................................................... 8-1

8.2.1 QC edit ........................................................................................................................ 8-1

8.2.2 QC analysis ................................................................................................................. 8-8

8.2.3 QC result review ....................................................................................................... 8-18

8.3 X QC ............................................................................................................ 错误!未定义书签。


8.3.1 QC edit ...................................................................................................................... 8-33

8.3.2 QC analysis ............................................................................................................... 8-37

8.3.3 QC result review ....................................................................................................... 8-49

4
Table of Content

8.4 X-B QC ..................................................................................................................................... 8-63

8.4.1 QC principle .............................................................................................................. 8-63

8.4.2 QC edit ...................................................................................................................... 8-63

8.4.3 QC analysis ............................................................................................................... 8-67

8.4.4 QC result review ....................................................................................................... 8-67

8.5 X -R QC ................................................................................................................................. 8-78


8.5.1 QC edit ...................................................................................................................... 8-78

8.5.2 QC analysis ............................................................................................................... 8-81

8.5.3 QC result review ....................................................................................................... 8-94

8.6 Repeatability ........................................................................................................................... 8-109

8.6.1 Save ..........................................................................................................................8-111

8.6.2 Data export .............................................................................................................. 8-112

8.6.3 Exit .......................................................................................................................... 8-112

8.7 Carryover ................................................................................................................................ 8-113

Chapter 9. Calibration ......................................................................................................................... 9-1

9.1 Overview ..................................................................................................................................... 9-1

9.2 Calibration frequency.................................................................................................................. 9-1

9.3 Calibration method...................................................................................................................... 9-2

9.3.1 Preparation .................................................................................................................. 9-2

9.3.2 Manual calibration ...................................................................................................... 9-4

9.3.3 Calibrators calibration ................................................................................................. 9-7

9.3.4 Fresh blood calibration.............................................................................................. 9-11

9.3.5 Verify calibration factor ............................................................................................ 9-17

Chapter 10. Services..................................................................................................................... 10-1

10.1 Overview ................................................................................................................................... 10-1

10.2 Maintenance .............................................................................................................................. 10-1

10.2.1 Manual sleep ............................................................................................................. 10-1

10.2.2 Exit sleep................................................................................................................... 10-3

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Table of Content

10.2.3 Reagent replacement ................................................................................................. 10-5

10.2.4 Cleaning .................................................................................................................... 10-7

10.2.5 Maintenance .............................................................................................................. 10-8

10.2.6 Whole machine maintenance .................................................................................. 10-18

10.2.7 Auto-cleaning .......................................................................................................... 10-23

10.2.8 Auto-prompt for probe cleanser soaking................................................................. 10-23

10.2.9 Scheduled Sleep ...................................................................................................... 10-26

10.3 Status enquiry ......................................................................................................................... 10-26

10.3.1 Voltage and current ................................................................................................. 10-26

10.3.2 Temperature and pressure ....................................................................................... 10-28

10.4 Version and configuration information ................................................................................... 10-29

10.5 Self-testing .............................................................................................................................. 10-31

10.5.1 Self-testing of syringe and sampling assemblies..................................................... 10-31

10.5.2 Valve self-testing ..................................................................................................... 10-32

10.5.3 Other self-testing ..................................................................................................... 10-33

10.6 Counter.................................................................................................................................... 10-34

10.7 Log .......................................................................................................................................... 10-37

10.7.1 Parameter modification ........................................................................................... 10-37

10.7.2 Other Logs .............................................................................................................. 10-38

10.7.3 Failure information ................................................................................................. 10-40

10.7.4 All Logs .................................................................................................................. 10-41

Chapter 11. Failure solution...............................................................................................................11-43

11.1 Overview ................................................................................................................................. 11-43

11.2 Failure Information and Solutions .......................................................................................... 11-43

6
Manual Overview

Chapter 1. Manual Overview

1.1 Overview
This chapter introduces how to use this LW D6500 operation manual. This operation manual is provided with
the machine. It gives detailed information about the use, function and operation of LW D6500. Please read
and understand the contents in the manual carefully before use LW D6500 to ensure proper usage, maximal
performance and safety of the operators.

1.2 Application scope of the manual


This manual applies to medical examination professionals or trained doctors, nurses or laboratory technicians.
With it, these personnel can:
Know the hardware and software of LW D6500;
 Set system parameters;
 Perform daily operations;
 Maintain system and troubleshoot.

1.3 Manual Guide


This operation manual consists of 11 main chapters and 1 appendix. The user refers to corresponding chapters
based on required information.
Chapters Introduction

Chapter 2 Installation Introduction to installation requirements of LW D6500

Chapter 3 System It introduces the application of LW D6500, measured parameters,


Overview instrument construction, software interface and software operation

Chapter 4 Operating It introduces the measurement principle and procedure of LW D6500


Principles application

Chapter 5 Setting It introduces the settings of system parameters such as software date
format and parameters units

Chapter 6 Daily It introduces the collection and preparation methods of samples, as well
operations as sample analysis procedures and daily operations

Chapter 7 Results It introduces the review of sample analysis results

1-1
Manual Overview

Review

Chapter 8 QC It introduces the basic requirements of QC and the QC methods


provided by LW D6500

Chapter 9 Calibration It introduces the basic requirements of calibration and the calibration
methods provided by LW D6500

Chapter 10 Services It introduces maintaining and testing methods of LW D6500

Chapter 11 It introduces troubleshooting methods of LW D6500


Troubleshooting

Appendix A It introduces specifications of LW D6500


Specification

1.4 Manual convention


This manual uses different fonts and formats to distinguish the contents with special meanings.
Formats Meanings

[××] The contents in [ ] correspond to the keys on the external


keyboards

"××" The contents in " " are the LW D6500 information displayed in the
software interface

×× The content in italic font is the cited chapters and sections

All the figures provided in this manual represent examples only. Please do not use them for other purposes.
The diagrams, settings or data in the figures may not be completely consistent with those actually displayed
on the LW D6500.

1.5 Security information


This manual uses the following symbols to represent information that is dangerous or that needs special
attention.
Symbols Meanings

Biological risk:

Prompt operators to operate according to the instructions under the symbols,


otherwise, potential biological infectious risks may exist.

1-2
Manual Overview

Warnings:

Ask operators to operate according to the instructions under the symbols.


Otherwise, they may suffer personal injuries.

Cautions:

Ask operators to operate according to the instructions under the symbols.


Otherwise, this may lead to product faults, damage or impact the test results.

Note:

Ask operators to operate according to the instructions under the symbols. It


emphasizes the important information in operation steps or the contents that
operators need to pay special attention to.

Biological risk:

1. All items (samples, controls, calibrators, reagents, wastes, etc.) and regions
that come into contact with these items have the potential of biological
infection. Operators should observe laboratory safety operation rules and wear
personal protective devices (such as laboratory protective clothing, gloves,
mask, etc.) when touching relevant items and regions in the laboratory.
2. If the analyser leaks, the leaked liquid has a potential of spreading
biological infection.

Warnings:

1. Make sure to check all the doors/covers before starting instruments, and
make sure that they won't suddenly open or become loose while operating the
instrument.

2. Please take all the security measures provided by the instrument. Please do
not prohibit the use of any device or sensor that is for safety purpose.

3. Please respond and handle all warnings and failure in a timely manner.

4. Do not touch any moving parts.

5. Please contact Landwind Company or agent in a timely manner if there is


any damaged part.

6. Please be cautious when opening, closing, installing or disassembling the


door/cover.

1-3
Manual Overview

7. Please comply with the local provisions when discarding of the equipment.

Cautions:

1. Please strictly adhere to the instructions in this user's manual when using
this equipment.

2. Please only install software authorized by Landwind on the equipment’s


computer.

3. Please only install genuine software to prevent computer viruses.

4. Please take proper measures to prevent reagents from being polluted.

5. We recommend installing antivirus software on the computer and


performing periodic virus scan.

1-4
Installation

Chapter 2. Installation

2.1 Overview

Warnings:

Personnel unauthorised or untrained by Landwind may cause bodily injuries or damage


the analyser when unpacking or performing installation. Please do not unpack or install
the analyser without the presence of Landwind authorized personnel.

Note:

The sampling assemblies are fixed with plastic tie and binder clips when the instrument
was shipped from the factory to avoid the components from being damaged during
transportation. Cables and clips must be removed before using the instrument.

This analyser has been rigorously tested before it was shipped from the factory. The analyser has been
carefully packed before shipping to avoid any impact during transportation. Please carefully check the
packaging and see whether there is any physical damage when the analyser arrives. Please notify the
Landwind after-sales service department or regional agent in a timely manner should there be any damage.

2.2 Installation personnel


LW D6500 Five-differential Haematology Analyser can only be installed by Landwind Company or its
authorized agents. Users need to provide corresponding environment and space. When the analyser needs to
be relocated, please contact Landwind Company or the local agents.
Please notify Landwind Company and the local agents immediately when you have received the analyser.
Contact details of Landwind Company:
(1) Manufacturer: Shenzhen Landwind Industry Co., Ltd.
(2) Registered address: Room 408-413, Building E, Bijingyuan, Jingtian Road, Futian District, Shenzhen
(3) Manufacturing address: Zhuanchang Village, Langxin Neighbourhood Committee, Shiyan Street, Baoan
District, Shenzhen
Honglong Hi-Tech Park, Liyuan Industrial Region (Landwind Science and Technology Park)
(3) Telephone number: +86-0755-27353247
(4) Facsimile number: +86-0755-27353240

2-5
Installation

(5) E-Mail: service@landwind.com.cn;


(6) Website: http://www.landwindmedical.com.cn

2.3 Damage inspection


All the analysers have passed the rigorous tests of Landwind Company before packing and shipping. When
you have received this analyser, please check carefully before unpacking and see if the following damages
can be found:
(1) The outer packing is inverted or deformed;
(2) The outer packing has apparent traces of water;
(3) The outer packing has apparent traces of impact;
(4) The outer packing has signs of being opened;
Once the above-mentioned damages have been found, please notify the local agent immediately.
If the outer packing is intact, please unpacking the box and check with the presence of the agents and
employees of Landwind Company;
(1) Check whether all devices are complete per the packing list in the packing box;
(2) Check the appearance of all devices carefully and see if there is any rupture, damage or deformation.

2.4 Installation requirements

Warnings:

1. The analyser must be used in good grounding conditions.

2. Please ensure the input voltage meets requirements before switching on the analyser.

Cautions:

1. It is not recommended to install terminal software and database in the system disk.

2. Using a power strip may cause extra electrical interferences and lead to incorrect analysis
results. Please place the analyser near a power socket and avoid using a power strip.

3. Please use the supplied power cord. Using other power cords may damage the analyser or
lead to incorrect analysis results.

Contents Requirements

Site 1. The ground surface should be level and the operation platform must be steady and secured.

2-6
Installation

The loading capacity should be ≥100 kg;

2. The environment should be dust-free, without mechanical vibration, sources of heat and
wind, pollution, loud noise source and electrical interference;

3. Please avoid direct sunlight and have good ventilation;

4. The evaluation of electromagnetic environment of the laboratory is recommended before


running the equipment.

5. Do not put the equipment close to the source of electromagnetic interference to avoid
affecting the proper operation of the equipment.

1. The space reserved between the left and right doors of the analyser and the walls should be
≥100cm;

Space 2. The reserved space between the analyser back wall and the wall should ≥50cm;

3. Make sure that there is enough space on the operation platform and under the analyser to
place diluent and waste barrels;

Temperatu
15 ℃ - 30 ℃
re

Relative
10 % - 90 %
humidity

Atmosphe
ric 70 kPa - 110 kPa
pressure

Ventilatio There should be an exchange of air with the outside, adequate air flow and the source of
n wind should not blow directly towards the analysis part.

Power
supply AC 100V - 240V, input power ≤200 VA, 50/60HZ

The computer should meet the corresponding safety requirements with dual core CPU of
Computer 1.6G above and internal memory of 2.0G above. It should be pre-installed with Windows
XP/Win 7 operating system.

Electroma
gnetic Do not place it close to brush-type motor, flickering fluorescent light and electrical contact
wave device that will always be turned on and off.

The discharge of waste must comply with the requirements of local environmental protection
Waste
department.

2-7
Installation

2.5 Opening the packaging


(1) Open the outer packing box, take out the accessory kit, and then take out the analyser together with
protection and shockproof materials.
(2) Remove the protection materials: Including foam and PE bags.
(3) Open the right door (a slotted screwdriver is required to open the straight cam lock on the right door). The
figure after opening is as shown below. The indicated locations in the figure are two drive belts. The space
between these two transmission belts are fixed by binder clips and plastic tie respectively before leaving the
factory to avoid possible impact caused by vibrations and tilting during transportation. When removing the
packaging, the binder clips must be removed and the plastic tie must be cut.

Figure 2-1 Figure of right side of the instrument

2-8
Installation

2.6 System connections

Cautions:

Please ensure the lengths of the diluent tube and waste tube do not exceed 1500mm, and the
length of the diluent tube of all Lyse does not exceed 850mm.

2.6.1 Electrical connections and reagent connections

Figure 2-2 Electrical connection diagram

2-9
Installation

Figure 2-3 Reagent connection diagram

2.6.2 Installation of diluent float sensor and replacement of reagent


 Installation of sensors
Complete the installation of the diluent float sensor according to Figure 2-3 and the following steps;
(1) Open the hole with cutting dotted line on top of the diluent reagent box and pull up the lid;
(2) Take out the stand for diluent bottle cap from the accessory kit as shown in Figure 2-4 below, and fasten
the stand on the bottleneck on the lower part of the lid to prevent the opening from being depressed;
(3) Rotate and open the lid (keep the lid), and avoid any foreign objects entering the barrel;
(4) Install the diluent float sensor assembly in the accessory kit according to Figure 2-5. Please keep the float
sensor in upright position during installation and tighten the lid on the float sensor.
 Reagent replacement
The replacement procedure of the diluent is the same as the steps above. Retain the screw capping of the
empty diluent barrel for future use.

2-10
Installation

Figure 2-4 How to open the diluent barrel

Figure 2-5 Installation of diluent float sensor

2.6.3 Installation of waste float sensor

Note:

The float sensor used in this equipment is only suitable for the waste barrels provided by
our company or that with the same model (for examples, used diluent barrel).

(1) Take a suitable waste barrel (the barrel can be an empty diluent barrel. Pull out the opening on the diluent
barrel to expose the barrel mouth), and open the lid;
2-11
Installation

(2) Install the waste float sensor assembly in the accessory kit according to Figure 2-6. Please keep the float
sensor in upright position during installation and tighten the lid on the sensor to prevent waste from
overflowing;

Complete the installation of the waste float sensor according to Figure 2-3 and the steps above.
Note: Please replace the waste barrel in a timely manner when the machine prompts that the waste is full to
avoid pollution and losses.
Please follow the steps above to replace the waste barrel. The replaced waste must be sealed and handled
properly to avoid pollution.

Figure 2-6 Installation of waste float sensor

2-12
System Overview

Chapter 3. System Overview

3.1 Overview
LW D6500 Five-differential Haematology Analyser is a kind of in vitro diagnostic equipment and is used for
the counting of whole blood cells and WBCs with five-differential for human blood samples in clinical
laboratories.

3.2 Scope of application

Note:

This analyser is a clinical examination instrument used for filtering. Doctors are required to
consider the clinical examination results or other test results when making clinical
judgements based on the analysis results.

This analyser is suitable for counting whole blood cells and WBCs with five-differential for human blood
samples in the laboratory environment.
The analyser provides quantitative analysis results of 24 kinds of blood parameters and 4 kinds of research
parameters, 3 histograms, 1 scattergram, and 2 kinds of measuring modes: CBC and CBC+DIFF.
Parameter Abbreviations CBC CBC + DIFF

White blood cell count WBC * *

Neutrophils percentage Neu% / *

Lymphocytes percentage Lym% / *

Monocytes percentage Mon% / *

Eosinophils percentage Eos% / *

Basophils percentage Bas% / *

Neutrophils number Neu# / *

Lymphocytes number Lym# / *

Monocytes number Mon# / *

Eosinophils number Eos# / *

Basophils number Bas# / *

3-1
System Overview

Abnormal lymphocytes percentage ALY% (research / *


parameters)

Large immature cells percentage LIC% (research / *


parameters)

Abnormal lymphocytes number ALY# (research / *


parameters)

Large immature cells number LIC# (research / *


parameters)

Red blood cell count RBC * *

Haemoglobin concentration HGB * *

Mean corpuscular volume MCV * *

Mean corpuscular haemoglobin MCH * *

Mean corpuscular haemoglobin MCHC * *


concentration

Red blood cell distribution width RDW-CV * *


coefficient of variation

Red blood cell distribution width RDW-SD * *


standard deviation

Haematocrit HCT * *

Platelet count PLT * *

Mean platelet volume MPV * *

Platelet distribution width PDW * *

Plateletcrit PCT * *

Large platelet cell ratio P-LCR * *

White blood cell/basophils histogram WBC/BASO Histogram / *

White blood cell histogram WBC Histogram * /

Red blood cell histogram RBC Histogram * *

Platelet histogram PLT Histogram * *

Differential scattergram DIFF Scattergram / *

3-2
System Overview

Note:

1. "*" means provided in this measuring mode, and "/" means not provided in this
measuring mode.
2. ALY%, LIC%, ALY# and LIC# are research parameters and are only used in researches.
They cannot be used as the basis of clinical diagnosis. For more information about research
parameters, please refer to the research parameters in General Settings in 5.3.1.

3.3 Structure of analyser


The analyser is composed of analyser and accessories.

Warnings:

1. Before operating the analyser, please ensure all the doors/covers/plates are in good
conditions and confirm that they will not be opened or loosen during operation.
2. This analyser is relatively heavy. It may cause bodily injuries if carried by only one
person. It is recommended to move the analyser by two people together if it needs to be
moved. The corresponding security procedures must be observed and appropriate tools are
needed.

Cautions:

If other software is installed or removable storage devices are used on the computer
installed with the analyser system, or the computer is used for other purposes (play games,
access the Internet, etc.), then the computer may be subject to computer viruses that may
lead to system damage or data errors. Please ensure the equipped computer is only used for
the sole purpose of the analyser system.

3-3
System Overview

Figure 3-1 Front view of analyser

1: Power supply/status state light 2: Probe 3: Counting button

The probe is sharp and may contain items with biological risks. Please
be extremely careful when working!

3-4
System Overview

Figure 3-2 Rear view of analyser

1: Network jack 2: Power input socket

3: L-65LH LYSE fitting 4: L-65LEO II LYSE fitting

5: L-65LEO I LYSE fitting 6: Dilute fitting

7: Waste fitting

1. The instrument must be used under good grounding condition.

2. To avoid electric shock, please disconnect power source before examination


and repairing.

3. To prevent fire, please use fuses of specific type and current.


Biological risk:

Prompt operators to operate according to the instructions under the symbols,


otherwise, potential biological infectious risks may exist.

3-5
System Overview

Figure 3-3 Rightside view of analyser (open the right door)

1: Optical system 2: Sampling assembly

3: Impedance counting cuvette 4: DIFF cuvette

5: Pressure-off valve 6: Waste pump

7: Valve 8: The negative pressure chamber

9: Air pump 10: The positive pressure chamber

11: Volume measuring assembly

Laser radiation exists when opened. Please do not look straight into the laser
beam or through optical instruments.

3-6
System Overview

Figure 3-4 Leftside view of analyser (open the left door)

1: Main board 2: Valve

3: Sensor 4: syringe assembly

5: Power switch

Please do not put your hands near the bottom plate for syringe guide groove to
avoid crushing injuries when the machine is running.

3.3.1 Analyser
The main part of this product is used for completing analysis and processing data.

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System Overview

3.3.2 Power/status state light


Power/status state light is located in the middle of the front right portion of the analyser. It is used to indicate
various statuses of the analyser, such as ready, running, failure, sleeping and shutdown.

3.3.3 Power switch


Power switch is located on the left side of analyser and is used to turn the analyser on or off.

Cautions:

Do not turn the power on and off repeatedly in a short time to prevent the analyser
from being damaged.

3.3.4 Counting button

3.3.5It is located at the back of the probe and is used to start the counting

operations, add diluent or cancel sleeping.

3.3.6 Network jack


There is 1 network interface behind the analyser that is used to connect with the external computer.

3.4 Operation interface


The operator can log into the operation interface when the start-up process has finished.

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System Overview

This interface can be divided into several sections according to functions as below:
1 – Interface title section
The title name of the current interface is displayed at the bottom of the interface. For examples, if "Daily
Check" is displayed, then it is currently showing " Daily Check " interface.
2 – Counting status icon
It displays the current counting status, and the display method is the same as the power/status state light on
the analyser.
The green light keeps on: Status of allowing to perform counting;
The green light flicker: Status of performing fluidics sequence. No counting allowed;
The yellow light keeps on: Non-failure status of not allowing to perform counting (for example: Sleeping
status);
The red light flickers: Failure status of not allowing to perform counting.
3 – Daily check
Display the start-up information.
4 – Status display section
It is located on the upper right of the interface. The statuses from left to right are:
 Connection status of analyser and computer

The icon is : The analyser is not connected with the computer;

The icon is : The analyser is connected with the computer;


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System Overview

 Printing device status


The icon is grey: The computer is not connected with the printing device;
The icon is coloured: The computer is connected with the printing device;
Icon blinks: The printing device is printing at the moment.
5 – Minimize button
The software interface can be minimized to the taskbar of the operating system after clicking this button.

Note:

When the minimization is performed, the software interface display can be restored by
clicking the software interface icon in the taskbar.

6 – System time
It displays the system time set in the current operating system. Please refer to Chapter 5 Settings for the
modification methods of the system date format.
7 – Input method button
It provides selection and display of input methods. Click the input method button and open the input method
language bar menu. The user can click the desired input method option and switch the current input method
to the expected type and then input contents.
8 – Fault information section
When any fault appears, a fault assistance dialogue box will pop up, and corresponding fault information will
display in this section. When there is more than one fault, the fault information in this area will display
alternatively, and the severity of the fault will be differentiated via different colours. From high level to low
level, the background colours in use are red, orange, blue and green in sequence. Please refer to Chapter 11
Troubleshooting for detailed troubleshooting methods.
9 - Operation/status information prompt area
This area shows the prompt information about the current operation of the analyser/computer, or the prompt
information about the status of the analyser/computer.
10 - Logged-in user information area
This area shows the user level and user name of the current logged-in users of the terminal software.
11 - Menu button
You can open the system menu by clicking Menu located at the upper left portion of the interface. Click a
menu item. If there is no " " mark at the end of this menu item, then the corresponding interface or
dialogue box will be opened; If there is a " " mark at the end of it, then the corresponding submenu of this
item will be opened. Click the submenu item, and the corresponding interface or dialogue box will be opened.
12 - Shortcut button area

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System Overview

The upper area of the interface is the shortcut button area. If you click a shortcut button, it means that you've
selected this button, and you will enter the corresponding interface immediately, or a dialogue box will pop
up immediately.
13 - Non-full screen display functional area
Double click to make the interface size ideal.

3.4.1 Sample analysis

Click the shortcut button and enter the sample analysis interface:

This interface can be divided into several sections according to functions as below:
Four coagulation tests, ESR, and blood type input area

Click and the figure below will pop up:

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System Overview

Enter the maximum and minimum of the reference value, and then click OK. The reference value then will be
stored at the right side of the input box.
Place the mouse pointer in the corresponding edit box based on the requirements. When a cursor appears in
the box, you can begin editing;
Click the arrow button to select when editing blood types as shown in the figure below:

2 - Information editing area


Make edits inside the sample information editing box at the lower left. Some information is combo box
option;
Click the arrow button on the right of the information editing box as shown in the figure below, and then
select the corresponding information in the drop-down list.

Click the counting button to finish counting (you can edit information during the counting). Click

to save.

Click to review and click to edit major parameters, as shown below:

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System Overview

Click and a dialogue box will pop up, as shown below. Click OK to restore the value
before modifying.

Click to print the results;

3 - Sample result display area


The sample results and its reference range will be displayed in this area;
4 - Histogram display area
The histograms of WBC/BASO, RBC and PLT will be displayed in this area;
5 - Warning display area
Warning information that surpasses normal ranges will be displayed in this area;
6 - Scattergram display area
The WBC differential chart of this sample will be displayed in this area;

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System Overview

3.5 Software operation


Before using the software matched with the analyser, please make sure that you have been familiarized with
the significance of the following basic operations or interface display.

3.5.1 Move the pointer


Move the mouse pointer displayed on the interface by moving the mouse.

3.5.2 Click
Move the pointer to the content that you want to select, press the left mouse button and then release.

Note:

If the content isn't selected, please repeat this operation; If needed, please check the
connection of the mouse. If the problem continues after checking, please contact the
after-sales department or the agent of the region of Landwind Company.

3.5.3 Double click


Move the pointer to the content that you want to select, press the left mouse button twice consecutively and
quickly and then release.

Note:

If the content isn't selected, please repeat this operation; If needed, please check the
connection of the mouse. If the problem continues after checking, please contact the
after-sales department or the agent of the region of Landwind Company.

3.5.4 Right click


Move the pointer to the content that you want to select, press the right mouse button and then release.

Note:

If the content isn't selected, please repeat this operation; If needed, please check the
connection of the mouse. If the problem continues after checking, please contact the
after-sales department or the agent of the region of Landwind Company.

3-14
System Overview

3.5.5 Drag the scroll bar


The information contained in some windows cannot be shown within a screen. In this case, a horizontal or
vertical scroll bar will appear. The operator can drag the scroll bar through in any way below to display other
information within the window. The schematic diagram of the scroll bar is shown below:

(1) Click the arrow button on the scroll bar;


(2) Move the pointer to the slider of the scroll bar, press and hold the left mouse button and drag the slider
along the scroll bar;
(3) Click the blank area on the scroll bar;

3.5.6 Tab
The tab shows one-page contents among several pages of interface information. For example, click Setting
label in the L-J QC interface, enter the Setting tab, browse the information and set relevant information. The
"Setting" tab is shown below.

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System Overview

3.5.7 Button
3.5.7.1 Common button
After clicking the common button, the software will perform the corresponding function as shown on the
respective button. For example, printing operation will be performed when click Print shown in the figure
below.

3.5.7.2 The arrow button of combo box


Clicking this button will open a combo drop-down list, as shown in the figure below. The popped drop-down
list will display all the options.

Click arrow button again to hide the drop-down list, as shown in the figure below.

When the drop-down list is open, you can use the [↑] and [↓] keys on the keyboard to shift the highlighted bar
to the item you want to select;

3-16
System Overview

When the drop-down list is open, you can hide the drop-down list by using the [Enter] key on the keyboard or
click any option directly. In this case, the currently selected option (highlighted item) will replace the original
contents in the combo box;
When the drop-down list is open, you can hide the drop-down list by using the [Esc] key on the keyboard. In
this case, the existing content in the combo box will remain the same.

Note:

Horizontal/vertical scroll bars will appear if the content in a list cannot be displayed fully
on the screen. The operator can drag the scroll bars or use the [PgUp] and [PgDn] keys on
the keyboard to browse complete information.

3.5.7.3 The arrow button of date picker


The date picker is shown in the figure below.

After clicking the arrow button on the date picker, a date selection box, as shown below, will pop up.

Select year: Click currently displayed year and the up and down arrow buttons will appear on the right. In this
case, click up/down arrow button to switch to the year you want to select.
Select month:
Method one: Click the left/right arrow buttons on two sides of the selected box directly to switch to the
month you desire.
Method two: Click currently displayed month, and click the month you want to select in the month list shown
bellow.

3-17
System Overview

Select date: Click the date you want to select. The date selection box is concealed. The original date in the
date picker will be replaced by the selected date (including year, month and day).
When the date selection box pops up, you can conceal it by using [Esc] key on the keyboard. The existing
content in the date picker will remain the same.

3.5.7.4 Radio button


Click the radio button you want to select, and a mark will appear in the circle on the left side of this option,
which indicates that the option is selected. For example, after clicking Prompt shown in the following chart,
this option is selected and the "Do not prompt" option becomes unselected.

Note:

In the same setting, you can only select one radio button.

3.5.8 Check box


Click the check box option you want to select, and a "√" mark will appear in the circle on the left side of this
option, which indicates that the option is selected. For example, after clicking Press [Enter] key to switch
among different fields shown in the following chart, this option is selected.

Click Press [Enter] key to switch among different fields again, and the "√" mark will disappear, which
indicates that this option is unselected, as shown in the following chart.

3-18
System Overview

Note:

In the same setting, you can only select one radio button.

3.5.9 Edit box


Click edit box. You can perform editing when a cursor is present in the box. The inputted characters will be
inserted to the location of the cursor, which is shifted to the right at the same time. After entering the patient
name into the name edit box, it will be displayed as is shown in the following chart.

In the edit box, you can also execute the following operations:
(1) Use [←] and [→] keys on the keyboard to shift the cursor;
(2) Use [Home] and [End] keys on the keyboard to shift the cursor to the left side of the first character or to
the right side of the last character.
(3) Use [Delete] key on the keyboard to delete the character on the right side of the cursor.
(4) Use [Backspace] key on the keyboard to delete the character on the left side of the cursor.
(5) Use [Tab] key on the keyboard to switch to other edit boxes.

Note:

1. Edit boxes with different uses have different requirements for characters that are allowed
to be inputted.

2. There is no need to input separators in the time edit box and IP address edit box.

3. Horizontal/vertical scroll bars will appear if the content in the edit box cannot be
displayed fully on the screen. The operator can drag the scroll bars or use [PgUp] and
[PgDn] keys on the keyboard to browse complete information.

3.5.10 Information box


You can only browse but cannot edit the information in the information box, as is shown in the following
chart.

3-19
System Overview

Note:

Horizontal/vertical scroll bars will appear if the content in the information box cannot be
displayed fully on the screen. You can drag the scroll bars or use [PgUp] and [PgDn] keys
on the keyboard to browse complete information.

3.5.11 Combo box


A combo box is composed of an edit box and an arrow button, as is shown in the following chart.

You can select the combo box with reference to the operations described in the Arrow button of the combo
box chapter. If a combo box is editable, the operator can perform editing in it with reference to the operation
methods in the Edit box chapter.

3.5.12 Table
A table is composed of multiple cells, and sometimes it also contains combo boxes.
Click a certain cell and it will be selected, as is shown in the following chart.

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System Overview

Now you can execute the following operations:


(1) Use [↑], [↓], [←] and [→] keys on the keyboard to select the relevant cell;
(2) Use [Home] and [End] keys on the keyboard to select the leftmost or rightmost cell in the current row;
(3) Use [Enter] key on the keyboard to select the next cell in the current column;
(4) Use [Tab] key on the keyboard to select the next cell in the current row;
If cells in a table are editable, double click a certain cell, and then a cursor will appear. The inputted
characters will be inserted to the location of the cursor, which is shifted to the right at the same time. A cell
under editing state is shown in the following chart.

You can execute the following operations in a cell:


(1) Use [←] and [→] keys on the keyboard to shift the cursor in the cell;
(2) Use [Home] and [End] keys on the keyboard to shift the cursor to the left side of the first character or to
the right side of the last character.
(3) Use [Delete] key on the keyboard to delete the character on the right side of the cursor.
(4) Use [Backspace] key on the keyboard to delete the character on the left side of the cursor.
(5) Use [Enter] key on the keyboard to conceal the cursor and exit editing.

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System Overview

Note:

1. If a table has check boxes, you can select records in certain rows/columns in the table
according to the operation methods of check box. If you do not exit the terminal software,
when you switch among each interface, the existing "√" mark will not clear.
2. If a table has check boxes, after clicking a check box, you will select or remove the "√"
mark of a record that is highlighted.
3. If you want to continuously select multiple records in a table, click the check box in front
of the start record to select it with a "√", then press the [Shift] key on the keyboard, and
click the check box in front of the end record to select it with a "√", so as to select all
records between the start record and the end record with "√".
4. Horizontal/vertical scroll bars will appear if the content in a table cannot be displayed
fully on the screen. You can drag the scroll bars or use the [PgUp] and [PgDn] keys on the
keyboard to browse complete information in a table.

3.5.13 System menu


After clicking Menu, the system menu pops up and displays all first-class menu items. If there is a " " mark
behind a menu item, it indicates that the item has submenus.

3-22
System Overview

 Enter the interface or dialogue box corresponding to a certain level menu item
Directly click the menu item you want to select.
 Enter the interface or dialogue box corresponding to a certain submenu item
Click the relevant first-class menu item of the submenu item, and then click the submenu item.
 Close menu
Click Menu to close the system menu.

3.5.14 Directory tree


A directory tree can display all contents at each level in the directory simultaneously.
If there is a "+" mark in front of a certain directory item, it indicates that this directory has sub-directories.
Clicking the directory item will display all the sub-directories in the next level. Meanwhile, the "+" mark will
change to "-" mark (Click the directory item again and all its sub-directories will be concealed. Then the "-"
mark will be return to a "+" mark), as is shown in the following chart.

If there is no "+" mark or "-" mark in front of the directory item, it indicates that there is no sub-directory for
this directory item. Clicking the directory item will display its related information directly;
Use [↑] and [↓] keys on the keyboard to shift the highlight line to the directory item you want to select;
Use [Home] or End] keys on the keyboard to shift the highlight line to the first directory item or to the last
directory item;
Using the [Enter] key on the keyboard can display sub-directories of a certain directory item. If the directory
item does not have sub-directories, directly display its relevant information;
If the sub-directories of a certain directory have been displayed, they can be concealed via using the [Enter]
key on the keyboard.

3-23
System Overview

Note:

Horizontal/vertical scroll bars will be present if the content in a directory tree cannot be
displayed fully on the screen. The operator can drag the scroll bars or use the [PgUp] and
[PgDn] keys on the keyboard to browse complete information.

3.5.15 Dialogue box


According to different function buttons, the dialogue boxes can be divided into "Confirm" dialogue boxes,
"Confirm/Cancel" dialogue boxes, "Yes/No" dialogue boxes, "Yes/No/Cancel" dialogue boxes and some
special prompt dialogue boxes.
A dialogue box is composed of a title bar, an information tab and function buttons. Take the
"Confirm/Cancel" dialogue box shown in the following chart as a descriptive example.

After selecting the date you want to delete, if you click OK, the dialogue box will be closed and the relevant
deleting operation will be executed. If you click Cancel, the dialogue box will be closed without executing
any operations.

3.5.16 Record switch bar


A record switch bar displays the location of the current record within all records in the form of
"Location/Total" and the total number of all records. It is shown in the following chart:

The "91/171" in the chart above indicates that there are 171 records in total and the current record is the 91th
record.

If you want to switch to the former record or to the following one of the current record, please press
or ;

3-24
System Overview

If you want to switch to the first record or to the last one, please press or ;

Click the edit box of the record switch bar, enter the relevant location number of the record you want to
browse and use the [Enter] key on the keyboard. Then the interface will switch immediately to the selected
record.

3.6 Operation help


The software provides the function of browsing operation help.

3.6.1 Browse help information


If you want to browse help information, please select Menu  Help  Help, and then the following help
dialogue box will pop up.

The help dialogue box displays help information of the current interface and relevant directory items
(highlighted directory items) by default.
If you want to browse other help information, please click the relevant directory item, and then you can
browse the selected help information on the right side of the interface.
You can close the help dialogue box via clicking × on its upper right corner.

3-25
System Overview

3.6.2 Search help information


If you want to search help information according to keywords, please click Menu  Help  Help, to
display help information of the current interface and relevant directory items (highlighted directory items).

Click Search tab so as to provide an entering box for searching information.

Enter the keywords you want to search, click Start or directly press the [Enter] key on the keyboard to start
searching.

3-26
System Overview

When the searching has been completed, the relevant directory item of all results that contain the keywords
will be displayed at the lower left side of the tab. The relevant help information of the highlighted directory
item will be displayed on the right side of the interface.
If you want to browse other search results, then click the corresponding directory items, so you can browse
help information on the right side of the interface.

3.7 Reagent, controls items and calibrators


Analyser, reagents, controls items and calibrators form a system. They must be used as a whole to ensure the
system's performance. The operator must use specified reagents of Landwind (See appendix A specification).
Otherwise, the analyser may be damaged and the performance specifications described in the instructions
cannot be attained. Non-specified reagents cannot ensure reliable analysis data. The "Reagents" mentioned in
the operating instructions are used specifically for the analyser.
Packages of each reagent must be checked before use. The damage of packages may affect the reagents'
quality. Ensure that the package is not damp or leaking. If this happens, do not use the reagent.

Note:

1. For use and storage methods of a certain reagent, refer to the reagent's instructions.

2. The operator should perform background test after change diluent or Lyse, make sure that
the background value is within the normal range, and prepare for sample analysis.

3. Please ensure that reagents are used before the expiry date mentioned in the instructions.

4. Position the reagent to make it stable before use.

3.7.1 Reagent
L-65D diluent
Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product can
provide blood cells with an environment similar to that of plasma when diluting blood samples, so as to
ensure the blood cell volume be maintained during certain times and provide a conducting environment for
blood cell counts.
L-65LEO I Lyse
Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product can
dissolve RBCs and four-part group WBCs
L-65LEO II Lyse
Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product can
dissolve RBCs and four-part group leucocytes
L-65LH Lyse

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System Overview

Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product can
dissolve RBCs and measure haemoglobin.
L-65 probe cleaning fluid
Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product is an
electrolyte solution contains sodium hypochlorite and can effectively remove protein stain. It is used for
cleaning and washing the sample injector of haematology analyser.

3.7.2 Controls and calibrators


Controls and Calibrators are used for calibration and QC.
Controls are industrial whole blood products, and are used for inspecting the counting function of the
analyser is normal or not. Controls are divided into three types with low value, medium value and high value.
You can monitor the operation condition of the analyser via running three kinds of controls tests everyday, so
as to ensure the reliability of results. Calibrators are also industrial whole blood products and are used for
calibrating the analyser. For the use and storage methods of controls and calibrators, see the instructions of
controls and calibrators.
The "Controls" and "Calibrators" mentioned in the instructions are dedicated controls and calibrators
specified by Landwind. They must be purchased from Landwind or from agents designated by Landwind.

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System Principles

Chapter 4. System Principles

4.1 Overview
This analyser applies the electrical electric impedance method to measure WBC/BASO, RBC and PLT; Use
the colorimetric method to measure HGB; Use semiconductor laser flow cytometry to determine WBC
five-differential data.

4.2 Absorbing sample


This analyser supports whole blood mode and predilution blood mode.
The analyser will absorb 16μL (CBC + DIFF mode) or 7μL (CBC mode) of samples if you want to analyse a
whole blood sample.
If you are to analyse a capillary blood sample, you should first manually dilute the sample the operator
should mix 20 μL of peripheral blood samples with 180 μL of a diluent outside the machine to form a diluted
sample containing a dilution ratio of 1: 10, the analyser will suck 81μL (CBC + DIFF mode) or 41μL (CBC
mode) of the diluted sample.

4.3 Diluted Sample


After being sucked into the analyser, the sample is divided into two parts, which are treated by different
reagents in parallel diluting processes to form detection samples used for RBC/PLT measurements, WBC
counting/HGB measurements and WBC differential measurements.
The analyser provides two work modes according to different requirements - whole blood, mode and
predilution blood mode.

4-29
System Principles

4.3.1 Whole blood mode


 RBC/PLT diluting process

6μL of whole blood


2500μL diluent
sample

About 1:420 dilution

Take out 52μl

2448μL diluent

About 1:20000 dilution


for RBC/PLT analysis

 WBC counting/HGB diluting process

6μL of whole blood sample 2500μL diluent

About 1:420 dilution

other 2454μL dilution

500μL L-65 LH lyse

About 1:500 dilution


for WBC/HGB analysis

 WBC differential diluting process

9μL of whole blood L-65 LEO Ⅰ:1100μL


sample L-65 LEO Ⅱ:90μl

About 1:133 dilution for


WBC analysis

4-30
System Principles

4.3.2 Predilution blood mode


 RBC/PLT diluting process

20μL capillary blood 180μL diluent

About 1:10 dilution

Take out 40μl

2460μL diluent

About 1:625 dilution

Take out 60μl

2440μL diluent

About 1:26000 dilution for


RBC/PLT analysis

4-31
System Principles

 WBC counting/HGB diluting process

20μL capillary blood 180μL diluent

About 1:10 dilution

Take out 40μl

2460μL diluent

About 1:625 dilution

Remain 2440μl

500μL l-65 lyse

About 1:770 dilution for


WBC/HGB analysis

 WBC differential diluting process

20μL capillary blood 180μL diluent

About 1:10 dilution

take 40μl

LEO Ⅰ:1100μL
LEO Ⅱ:90μL
About 1:307 dilution
for WBC analysis

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System Principles

4.4 WBC measurement

4.4.1 Flow cytometry by laser

Figure 4-1 WBC measurement

The blood sample is injected into the conical flow cell full of diluent through the nozzle when a certain
amount of blood cells are absorbed and treated with a specific amount of reagents. Cells are singly arranged
in line through the centre of the flow cell with the packing of diluent formed sheath liquid. When blood cells
suspended in the sheath liquid pass the laser detection area after a second acceleration, blood cells will be hit
with laser beams. The generated scattered light property is related to the cell size, cell membrane and
refractive index of internal structure of the cell. Low-angle forward scatter reflects the cell size and
high-angle forward scatter reflects the internal fine structure and particulate matter of the cell. Photodiode
receives these scattered light signals and transfers them into electrical pulses. According to these collected
electrical pulses data, you can get a two-dimensional histogram about the cell size and cell internal
information which is called scattergram as shown in Figure 4-2. The abscissa reflects the internal complexity
information of the cell and the ordinate reflects the cell volume.

4-33
System Principles

Figure 4-2 DIFF channel scattergram

By analysing the DIFF channel scattergram, the analyser presents the Lym%, Mon%, Eos% and Neu%.

4.4.2 Electrical electric impedance method


This analyser uses electrical electric impedance method to perform WBC/BASO counting. Detection sample
enters the WBC detection unit after a second diluting. Detection unit has a small hole, the detection hole. The
hole of both sides has a pair of positive and negative electrodes connected to the constant current power
supply. Because cells aren’t bad conductors, direct current resistance between electrodes will change, thus
forming a pulse signal which is proportional to the cell volume size at both sides of the electrodes when the
cells in the diluted sample pass the detection hole under the constant negative pressure. A series of electric
pulses are generated at both sides of the electrodes when the cells continuously pass the hole. The number of
pulses and the number of cells that passed through the hole are the same and the amplitude of the pulse is
proportional to the cell volume size.

4-34
System Principles

Figure 4-3 Electrical electric impedance method

Compare the enlarged collected electrical pulses with channel voltage threshold to which normal
WBC/BASO volume range corresponds. Figure out the number of electrical pulses in the WBC/BASO
channel where the electrical pulse amplitude is located. Therefore, all collected electrical pulses are classified
according to different channel voltage thresholds. The number of electrical pulses in the WBC/BASO channel
represents the number of WBC/BASO. The number of cells in each channel classified by the pulse voltage
amplitude determines the volume distribution of cells. This two-dimensional chart, which uses abscissa to
express cell volume and ordinate to express the relative number of cells, is the histogram, which reflects the
condition of cell colony distribution.
Derivation of WBC-related parametersThe analyser determines the lymphocytes percentage (Lym%),
neutrophils percentage (Neu%), monocytes percentage (Mon%) and eosinophils percentage (Eos%) through
analysing the DIFF channel scattergram and Lym area, Neu area, Mon area and Eos area of the diagram. And
calculate with the white blood cell count obtained by electrical electric impedance method to get the
lymphocytes number (Lym#), neutrophils number (Neu#), monocytes number (Mon#) and eosinophils
number (Eos#). The basophils number (Bas#) can be directly obtained by the electrical electric impedance
method. Units of the cells number are all 109/L.

4-35
System Principles

 White Blood Cell count


The analyser obtains the white blood cell count (WBC) through directly measuring the electric pulses to
which the whole blood cells correspond;
 Basophils number
The analyser obtains the basophils number (Bas#) through directly measuring the electric pulses to which the
basophils correspond;
 Basophils percentage
Bas#
Bas %   100 %
WBC

 background transmiss ion light intensity 


HGB  constant  Ln  
 sample transmissi on light intensity 

 Lymphocytes percentage

the number of particles in Lym area in DIFF channel


Lym%   100%
total number of the whole particles counting in DIFF channel except the ghost area

 Neutrophils percentage

the number of particles in Neu area in DIFF channel


Neu%   100%
total number of the whole particles counting in DIFF channel except the ghost area

 Monocytes percentage

the number of particles in Mon area in DIFF channel


Mon %   100%
total number of the whole particles counting in DIFF channel except the ghost area

 Eosinophils percentage

the number of particles in Eos area in DIFF channel


Eos%   100%
total number of the whole particles counting in DIFF channel except the ghost area

 Lymphocytes number

L y m#  W B C L y m%

 Neutrophils number
N e u#  W B C N e u%
 Monocytes number
M o n#  W B C M o n%

4-36
System Principles

 Eosinophils number
E o #s  W B C E o %
s

4.5 HGB measurement

4.5.1 Colorimetric method


The RBCs dissolve and release the haemoglobin when you add diluted sample to the lyse in the colorimetric
cuvette. The latter forms the haemoglobin compound after combining with the lyse. One side of the
colorimetric cuvette irradiates haemoglobin compound solution after letting the LED light pipe pass the
monochromatic luminotron with a wavelength of 525nm. The other side receives the transmitted light
through the phototube and transforms light intensity signals into voltage signals after enlarging the light
intensity signals. You can obtain the haemoglobin concentration of the sample by comparing with the voltage
generated by measured background transmission light intensity before adding the sample in the colorimetric
cuvette (only diluent in the colorimetric cuvette).

4.5.2 HGB
Haemoglobin concentration (HGB) is obtained by calculating with the following formula, and the unit is g/L.

4.6 RBC/PLT measurement

4.6.1 Electrical electric impedance method


This analyser uses the electrical electric impedance method principle to perform RBC/PLT counting.
Detection unit has a small hole, the detection hole. The hole of both sides has a pair of positive and negative
electrodes connected to the constant current power supply. Because cells aren’t bad conductors, direct current
resistance between electrodes will change, thus forming a pulse signal which is proportional to the cell
volume size at both sides of the electrodes when the cells in the diluted sample pass the detection hole under
the constant negative pressure. A series of electric pulses are generated at both sides of the electrodes when
the cells continuously pass the hole. The number of pulses and the number of cells that passed through the
hole are the same and the amplitude of the pulse is proportional to the cell volume size.

4-37
System Principles

Figure 4-4 Electrical electric impedance method

Compare the enlarged collected electrical pulses with channel voltage threshold to which normal RBC/PLT
volume range corresponds. Determine the number of electrical pulses in the RBC/PLT channel where the
electrical pulse amplitude is located. Therefore, all collected electrical pulses are classified according to
different channel voltage thresholds. The number of electrical pulses in the RBC/PLT channel represents the
number of RBC/PLT. The number of cells in each channel classified by the pulse voltage amplitude
determines the volume distribution of cells. This two-dimensional chart, which uses abscissa to express cell
volume and ordinate to express the relative number of cells, is the histogram, which reflects the condition of
cell colony distribution.

4.6.2 RBC
 RBC
The analyser obtains the red blood cell count (RBC) through directly measuring the electric pulses to which
the RBCs correspond, and the unit is 1012/L.
 Mean corpuscular volume
Calculate mean corpuscular volume (MCV) according to the red blood cell histogram, and the unit is fL.

4-38
System Principles

 Haematocrit, mean corpuscular haemoglobin and mean corpuscular haemoglobin concentration


Calculate the hematocrit (HCT) according to the following formula, and the unit is %; Mean corpuscular
haemoglobin (MCH), and the unit is pg; Mean corpuscular haemoglobin concentration (MCHC), and the unit
is g/L.

RBC  MCV
HCT 
10

HGB
MCH 
RBC

HGB
MCHC   100
HCT

RBC unit is 1012/L, MCV unit is fL and HGB unit is g/L.


 Red blood cell distribution width coefficient of variation
Red blood cell distribution width coefficient of variation (RDW-CV) is obtained from red blood cell
histogram, and the unit is %.
 Red blood cell distribution width standard deviation
Red blood cell distribution width standard deviation (RDW-SD) is obtained by calculating the standard
deviation of RBC volume distribution red cell volume distribution, and the unit is fL.

4.6.3 PLT
 Platelet count
The analyser obtains the platelet count (PLT) by measuring the electric pulses that corresponds to RBCs, and
the unit is 109/L.
 Mean platelet volume
The mean platelet volume (MPV) is calculated according to the platelet histogram, and the unit is fL.
 Platelet distribution width
Platelet distribution width (PDW) is obtained from the platelet histogram, which is the geometric standard
deviation of PLT volume distribution (10 GSD).
 Plateletcrit
The analyser calculates the plateletcrit (PCT) according to following formula, and the unit is %.
PLT unit is 109/L, and MPV unit is fL.

PLT  MPV
PCT 
10000

4.7 Cleaning
The analyser automatically cleans the components where the sample will flow through in each counting
process to ensure there is no sample left in the fluidics system.
4-39
Chapter 5. Settings

5.1 Overview
This analyser has been initialized before shipping from the factory. The environmental parameter is system
default when the users first start up the analyser. Some parameters of the analyser can be reset to meet
different requirements in practical application.
The analyser has divided the permission levels of the operators into users and administrators (administrator
has all the permissions of users) to ensure the product settings and data security. The functions of the settings
of these two permission levels will be described below.

5.2 Normal user level

5.2.1 General settings


When the operator logs in as a user, click Menu, select Settings and select any general settings item in the
context menu to bring up the General Settings window.

5-40
5.2.1.1 Date format
The system date format can be set. The change of date format will cause the changes of all corresponding
formats of the dates displayed and printed, including sampling date, submission date, inspection date,
worklist entry date, reagent expiry date, QC date, calibration date, etc.
Enter settings
Click Date Format in General Settings to enter the Settings window.

(1) Parameters explanation


Para Operations
Meanings
meters
Format Select a date display
Click the radio button desired.
type format
Click Apply to save settings of all items without closing the Settings
Apply Save settings
window.

OK Save settings Click OK to save settings of all items and close the Settings window.

Click Cancel without saving any settings and close the Settings
Cancel Cancel settings
window directly.

(2) Basic operations


1. Set printing parameters;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.

5-41
Note:

New settings will not be restored or saved when switching between the Settings menu until
Apply or OK is clicked.

5.2.1.2 Auxiliary
Enter settings
Click Auxiliary in General Settings to enter the Settings window.

(1) Parameters explanation


Para
Meanings Operations
meters
Refer to following
Sample ID explanation of Click the radio button desired.
sample ID
Please refer below
Others for other Click the check box option desired.
explanations
Click Apply to save settings of all items without closing the Settings
Apply Save settings
window.

OK Save settings Click OK to save settings of all items and close the Settings window.

Click Cancel without saving any settings and close the Settings
Cancel Cancel settings
window directly.

5-42
(2) Sample ID Settings
Click Auto-increment radio button to automatically increase the sample ID; Click Manual Input (barcode
scanning (not supported temporarily) or keyboard input) radio button to manually input the sample
ID."Auto-increment" is the default option of the analyser. Input the prefix of the sample ID in Prefix edit box

Note:

1. Both auto-increment and manual input support the methods of keyboard input and
barcode scanning (not supported temporarily) to enter a new number.

2. The setting of the prefix only affects the sample IDs to be tested later. The sample IDs
already tested and entered on worklist will not be affected.

3. If the prefix of the sample ID has been entered and the input mode is set as
"Auto-increment", then the prefix will automatically be displayed in the edit box of the
sample ID and allow the users to modify when the users enter/edit the information in the
future.

4. If the input mode of sample ID is set as "Manual Input (barcode scanning (not supported
temporarily) or keyboard input)", then the newly-added sample ID will be displayed as
blank by default in the worklist no matter the prefix has been set or not.

Other settings
If a new record needs to be added automatically according to the new record requirements after entering and
saving a record in the worklist, the operator can click "Automatically Jump to the Next Record after Saving
the New Record" checkbox. The selected box will be marked with "√". Selected by default in the analyser.
If jumping to the next record to be reviewed automatically after reviewing a sample result is required, the
operator can click "Automatically Jump to the Next Record after Reviewing a Sample Result" checkbox. The
selected box will be marked with "√". Selected by default in the analyser.
If switching between different information fields by pressing [Enter] is required, the operator can click
"Switch between Different Information Fields by Press [Enter]" checkbox. The selected box will be marked
with "√". It is selected by default in the analyser and support pressing [Tab] key to switch at the same time.
The dialogue box as shown below will pop up after the operator has clicked Information Field... behind this
option.

5-43
There is a check box before each field with all the status selected by default. That means information needs to
be entered for all fields by default. The operator can cancel the "√" in checkbox when clicking one (or some)
field checkbox. It indicates that pressing [Enter] or [Tab] key will skip these fields directly when entering
information. That means the operator does not need to enter the information in these fields. But the operator
can also use the mouse cursor and reposition to these fields to enter the relevant information.
Click OK to save settings of the information field and close this dialogue box to return to the auxiliary
settings interface.
If completed records are required to be deleted automatically from the worklist every time after counting, the
operator can click Automatically Delete Completed Records in the Worklist check box. The selected box
will be marked with "√". Not selected by default in the analyser.
If the sampling date and submission date are required to be inputted automatically, the operator can click
Automatically Input Sampling Date and Submission Date check box. The selected box will be marked with
"√" and is selected by default in the analyser.

(2) Basic operations

1. Select the settings you need;


2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.

Note:

New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.

5-44
5.2.1.3 Laboratory information
When the operator logs in as a user, click Menu, select Settings, and select Laboratory Information in the
pop-up context menu to bring up a dialogue box displaying laboratory information. All the information is
shaded and only the operator can check it.

 Basic operations
Click OK and then Cancel to exit "Laboratory Information" dialogue box.

5.2.2 User and password


When the operator logs in as a user, click Menu, select Settings and select User and Password in the pop-up
context menu to bring up a dialogue box displaying an information list of all administrators and users.

5-45
 Parameter explanation
Paramete
Meanings Operations
rs
Login name Current user name In the box, enter
Login Login password of current In the box, enter
password user
Confirm In the box, enter
Confirm user password
password
Comment Indicate current user In the box, enter
information information

 Basic operations

1. Input new password correctly into the Confirm and the Reconfirm edit box

2. After inputting the password, click Save;

3. If you want to exit from User and Password, click other buttons in the menu to switch to a
corresponding window directly.

Note:

New password can be null.


5-46
5.2.3 Shortcuts
When the operator logs in as a user, click Menu, select Shortcuts to bring up a dialogue box and display
short-cut code settings of department items by default.

Click on each button of the dialogue box respectively, Deliverer, Patient Type, Fee Type, Clinical
Diagnosis and Gender, to check short-cut code setting of the corresponding item.

Note:

You can check the corresponding fees of different fee types in the short-cut code setting of
Fee Type item.

 Basic operations

If you want to exit Shortcuts dialogue box, click other buttons in the menu item to switch to a corresponding
window directly.

5.3 Administrator level

5.3.1 General settings


When the operator logs in as the administrator, click Menu, select Settings and select any general settings
item in the context menu to bring up the General Settings window. Besides all the privileges of users, the
privileges that can be executed by the administrator are as follows.

5-47
5.3.1.1 Auxiliary
 Enter settings
Click Auxiliary in General Settings to enter the Settings window.


 Privilege settings
Edit the number of inspected samples.
If you want to permit users to edit and modify the number of samples with inspection result in the review
interface, the operator can click Edit the Number of Inspected Samples check box. The selected box will be
marked with "√", and it is selected by default in the analyser.
2. Edit inspection results

5-48
If you want to permit users to edit/ restore the inspection results directly, the operator can click Edit
Inspection Results check box. It is selected when "√" is displayed in the box, and it is selected by default in
the analyser.
3. Review samples
If you want to permit users to execute operations of review and cancel review of sample results directly, the
operator can click Review Samples check box. It is selected when "√" is displayed in the box, and it is
selected by default in the analyser.
 Basic operations

1. Select the settings you need;

2. Click Apply to save the setup information;

3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings
window.

Note:

New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.

5.3.1.2 Laboratory information


When the operator logs in as the administrator, click Menu, select Settings, and select Laboratory
Information in the pop-up context menu to bring up a dialogue box displaying laboratory information. All
the information is activated and allows the operator to enter and edit related laboratory information.

 Parameter explanation

5-49
Paramet
Meanings Operations
ers
Hospital name Name of Hospital In the box, enter
Laboratory name Name of laboratory In the box, enter
Responsible Responsible person's name of In the box, enter
person hospital
Contact Phone number of hospital In the box, enter
information
Postcode Postcode of hospital In the box, enter
Instrument Model number of instrument In the box, enter
model number
Instrument name Name of instrument In the box, enter
Installing date Installing date of instrument Select installing date in date picker
After-sales After-sales contact person's In the box, enter
contact person name
After-sales Contact information of In the box, enter
contact after-sales contact person
information
Explanation and instructions In the box, enter
Comments
concerning hospital

 Basic operations
1. Input needed information into the box of each parameter;
2. Click Apply to save the input information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings
window.

5.3.1.3 Reference unit


Some parameters of the analyser can adopt various units from which the operator can select according to
need.
 Enter settings
Click Reference Unit in General Settings to enter the Settings window.

5-50
Parameters in the same group display together by permutation, in which the first one is marked blue while
other parameters in the same group are shaded.

 Parameter explanation
Para
Meanings Operations
meters
Unit Selection of unit Select from the dropdown list, the default unit system is
system system "China".
Automatically display In the User-defined unit system, click Take the Default Value
Read the
default units of all
default to automatically display default units of all parameters in
parameters in
value corresponding cells.
corresponding cells
Click Apply to save settings of all items without closing the
Apply Save settings
Settings window.

Click OK to save settings of all items and close the Settings


OK Save settings
window.

Click Cancel without saving any settings and close the


Cancel Cancel settings
Settings window directly.

 Basic operations
1. In the User-defined unit system, please click the parameter item of preset unit in the list and then
click the given unit option of the parameter on the right to set new parameter unit.
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.

5-51
Note:

1. Select different unit systems and the unit list under it will display different contents.

2. If you select User-defined option, you can modify the unit of each parameter.

3. If you select other options except User-defined, you can only check but cannot modify
the unit of each parameter because there is no unit option to select.

4. Units of other parameters will change as the unit of any one parameter in the same
group changes.

5. The unit of parameter MCH changes with MCHC and HGB and cannot be modified
by the operator.

6. When the parameter unit changes, the data format displayed in the list will also
experience corresponding changes.

7. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
5.3.1.4 Print
 Enter settings
Click Print in General Settings to enter the Settings window.

 Parameter explanation

Paramet
Meanings Operations
ers
Title Title of the printing report Input the title of the printing report in the edit box,

5-52
Paramet
Meanings Operations
ers
which is "Blood Cell Inspection Report" by default.

Select the sheet type of Select from the drop down list, (A4, A5 and B5 paper
Sheet type
printing report supported) the default sheet type is A5.

Copies of the same


Input directly in edit box, the range for the copy that
Copies printing report needed
can be input is 1-100, and the default copy is 1.
printing
Select in the drop down list.(Both templates of all
Display optional report
Template parameters with figures for the whole page and all
print template
parameters without figures for half a page)
Click Preview, you can check the print renderings of
Check the print
report under the current setting.(Both templates of all
Preview renderings of the report
parameters with figures for the whole page and all
under the current setting
parameters without figures for half a page)
Set your own report print Click the Customization button and set your own
Customization
template report print template.
Parameter Name of parameter in the Select in the combo box, the default form of display is
name report "Chinese + English abbreviation".
The function of
automatically printing the
Click On to start the function of printing
Print report according to the set
automatically; Click Off to shut down the function of
automatically report template after
printing automatically. It is Off by default.
providing sample
counting results.
If Print Automatically is set to On, Print
Automatically after Review check box is activated.
The operator clicks check box to make "√" display in
Print the box so that it will not print the report immediately
Print it after the user
automatically analysing the sample but will print the report
reviews the sample
after review automatically after the user reviews the sample. If it is
not selected with "√", it will automatically print the
report after you finish analysing one sample.(Not
Supported Temporarily)
Click Print Flag check box and it is selected when "√"
Print Flag information in
Print Flag is displayed in the box. Not selected by default in the
the report
analyser.(Not Supported Temporarily)
Click Print Suspicious Mark "?" check box. It is
Suspicious In the report print
selected when "√" is displayed in the box. Selected by
mark "?" suspicious mark "?"
default in the analyser.(Not Supported Temporarily)
Click Print Reference Scope check box and it is
Reference The print reference scope
selected when "√" is displayed in the box. Selected by
range in the report
default in the analyser.
Print high and low alert Click Print High and Low Alert Mark check box and it
High and low
mark ("↑"or"↓") in the is selected when "√" is displayed in the box. Selected
alert mark
report by default in the analyser.
Click Print Edit Result Mark check box and it is
Edit result Print edit result mark ("E"
selected when "√" is displayed in the box. Selected by
5-53
Paramet
Meanings Operations
ers
mark or "e") in the report default in the analyser. For relevant operations of edit
results, you can refer to the introduction of Edit Result
function in 7.2.2.1 button function.(Not Supported
Temporarily)
Click QC Time check box and it is selected when "√"
Print QC time in the
QC time is displayed in the box. Selected by default in the
report
analyser.(Not Supported Temporarily)
Abnormal Click Print Abnormal Environment Temperature Mark
Print abnormal
environment ("T") check box and it is selected when "√" is
environment temperature
temperature displayed in the box. Selected by default in the
mark ("T") in the report
mark analyser.(Not Supported Temporarily)
Click Apply to save settings of all items without
Apply Save Settings
closing the Settings window.

Click OK to save settings of all items and close the


Ok Save settings
Settings window.

Click Cancel without saving any settings and close


Cancel Cancel settings
the Settings window directly.

 Basic operations
1. Set the print parameter;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.

5-54
Note:

1. After the operator completes the print setting, he should preview the print renderings
of the report under the current setting and print the report after confirmation.

2. If the Flag information is displayed in the software default report template, Print Flag
check box is activated.

3. If the Flag information is not displayed in the software default template or the selected
report template is the template customized by the user, then Print Flag check box is
shaded and in the status of not-selected.

4. If the Print Reference Scope option is selected with "√" in print setting, the option
Print High and Low Alert Mark is in the status of selected and the user cannot execute
modifications on it, which means both reference scope and high and low alert mark ("↑"
or "↓") must be printed in the report.

5. If the Print Reference Scope option is selected with "√" in print setting, but the user
wishes to change the Print High and Low Alert Mark option into the status of
not-selected, which means reference scope will be printed in the report but high and low
alert marks ("↑" or "↓") will not printed, contact Landwind after-sales service
department or Landwind designated agent.

6. If the option Print Reference Scope is unselected with "√" in print setting, which
means the user chose not to print reference scope, he can arbitrarily change whether the
option Print High and Low Alert Mark is selected or not, namely, he can select
arbitrarily whether to print high and low alert marks ("↑" or "↓") or not in the print.

7. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
5.3.1.5 Communication
Enter settings
Click the Communication button in General Settings to enter Settings window.

5-55
 Parameter explanation
Parameters Meanings Operations
If you choose Not Transmit, then it will not transmit
the 3 histograms in the communication of the sample
records; If you choose Transmit in a Bitmap Way, then
Transmission way of the 3 histograms will be transmitted to the LIS/HIS
Transmission system of client terminal in the graphical format. If
histogram in the
way of
communication of sample "Transmit as Data" is chosen, then 3 histograms will
histogram
record
be transmitted to the LIS/HIS system of the client
terminal as data respectively when communication is
conducted on the sample record. The default option is
"Transmit as Bitmap".(Not supported temporarily)

If "No Transmission" is chosen, then scattergram will


not be transmitted when communication is conducted
Scattergram will be on the sample record; If "Transmit as Bitmap" is
Scattergram transmitted when chosen, then scattergram will be transmitted to the
transmission communication is conducted LIS/HIS system of the client terminal in graphical
on the sample record
format when communication is conducted on the
sample record. The default option is "Transmit as
Bitmap".(Not supported temporarily)

The counting results of the Click On to start automatic communication


Automatic analysis will automatically be function; Click Off to turn off automatic
communication transmitted to the external data communication function. It is Off by default.(Not
management software supported temporarily)
Click Apply to save settings of all items without
Apply Save Settings
closing the Settings window.

5-56
Parameters Meanings Operations
Click OK to save settings of all items and close the
OK Save Settings
Settings window.

Click Cancel without saving any settings and close


Cancel Cancel settings
the Settings window directly.

 Basic operations
1. Set communication parameters;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.

Note:

1. The communication format settings in here are for data communication with the
outside (for examples, LIS system, etc.) instead of the communication between the
terminal and the instrument.
2. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.

5.3.1.6 Reference Range


The range of the reference values based on different normal groups can be set in actual use of the analyser. If
the analysis result of a sample is beyond the reference range, it will be considered as clinically abnormal.
There will be a "↑" or "↓" mark on the left side of the analyser display and test result of the printer output, in
which "↑" means the test result is above the upper limit and "↓" means the test result is below the lower limit.
The analyser includes general purpose, male adult, female adult, child and neonate and 5 user-defined
reference range, and the default setting for the analyser is "General Purpose". Every laboratory should adopt
the suitable reference range based on the actual sample condition to set the right reference range. The
reference range varies with race, gender, age and geographical location.
Enter settings
Click Reference Range in General Settings to enter the Settings window.

5-57
 Parameter explanation

Parameters Meanings Operations

Click Reference Group combo box and select the


reference group to set from "General Purpose", "Male
Reference group Name of reference group
Adult", "Female Adult", "Child", "Newborn" and
"User-defined 1–5."
Set reference Set reference group Please refer to the following to set reference group
group information information

Set a piece of Click Take as Default Value and the default reference
Take as default user-defined reference value range of the current reference group will
value group information as automatically be displayed on the form.
default value

Click Apply to save settings of all items without closing


Apply Save settings
the Settings window.
Click OK to save settings of all items and close the
OK Save settings
Settings window.
Click Cancel without saving any settings and close the
Cancel Cancel settings
Settings window directly.

 Basic operations
1. Drag the scroll bars and click Upper Limit or Lower Limit cell of the parameters that need to be reset;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.

5-58
Note:

1. 10 groups of reference value ranges are defined for each of the 10 reference group
respectively.
2. After the reference group is selected, the upper and lower limits of the reference range
on the table will also be changed.
3. The reference value range of the 5 user-defined reference groups is the same as that of
"General Purpose" reference group.
4. After the reference value range has been changed, it will not affect the high and low
alert messages of the original counting results but only affect the high and low alert
messages of the subsequent counting results.

5. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
Set reference group
Click Set Reference Group and the following dialogue box will pop up.

 Parameter explanation

Parameters Meanings Operations

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Parameters Meanings Operations

Name of reference group Double-click "Name" cell of the 5 user-defined


Name reference groups to modify the name of the user-defined
reference groups in the cells directly.
Double-click the corresponding cell of user-defined
reference group "Lower Age Limit" column to modify
The lower age limit value the age in the cell directly; Double-click the
Lower age limit of the reference group corresponding cell of age unit and a combo box option
will appear. The order from top to bottom is: Year,
month, day and hour. The operator can select the
options as required.
Double-click the corresponding cell of user-defined
reference group "Age Upper Limit" column to modify
The upper age limit value the age in the cell directly; Double-click the
Upper age limit of the reference group corresponding cell of age unit and a combo box option
will appear. The order from top to bottom is: Year,
month, day and hour. The operator can select the
options as required.

Double-click the corresponding cell of user-defined


Gender of reference reference group "Gender" and a combo box option will
Gender group appear. The order from top to bottom is: Not limited,
null, male and female. The operator can select the
options as required.

Click a reference group in the list to highlight it, and


Set as default Set a reference group as then click Set as Default Reference Group and this
reference group default reference group reference group will be taken as the default reference
group when inputting in the worklist.

Set a piece of Click a reference group in the list to highlight it, and
user-defined reference then click Take as Default Value and name of the
Take as default group information as reference group, upper and lower age limit values, age
value
default value unit and gender of the default reference group will be
displayed in the corresponding cells respectively.

Click Apply to save settings of all items without closing


Apply Save settings
the Settings window.
Click OK to save settings of all items and close the
OK Save settings
Settings window.
Click Cancel without saving any settings and close the
Cancel Cancel settings
Settings window directly.

 Basic operations
1. Set reference group information;
2. Click OK to save the setup information and refresh all settings values. Otherwise, click Cancel.

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Note:

1. The name and corresponding information of the 5 fixed reference groups in reference
group list cannot be modified.
2. The operator can modify the name, age range (including age and unit) and gender of
the 5 user-defined reference groups as required.
3. The reference group name input cannot be blank.
4. The reference group name input cannot be the same as the names of "General
Purpose, Male Adult, Female Adult, Child and Newborn", and names among all
user-defined reference groups cannot be duplicated as well.

 Basic operations
1. Settings for each reference range are complete;
2. Click Apply to save the input information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.
5.3.1.7 Research parameters
Research parameters include ALY%, LIC%, ALY#, LIC#.

Note:

1. Research parameters are only used in researches and cannot be used as the basis for
clinical diagnosis.

2. The settings of whether to display or print the research parameters, "*" flag and
declaration are effective to the display and printing of the research parameters for all
samples before and after settings.

3. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.

Enter settings
Click Research Parameters in General Settings to enter Settings window.

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 Parameter explanation

Parameters Meanings Operations

Display the research Click "Display Research Parameters" check box


Display research
parameters obtained from and the selected box will be marked with "√".
parameters
counting results Selected by default in the analyser.
Display research Click "Display "*" Mark" check box and the
parameters and need to
Display "*" mark selected box will be marked with "√". Selected by
display "*" mark
default in the analyser.

Display research Click "Display Declaration" check box the selected


parameters and "*" mark
box will be marked with "√". Selected by default
and also need to display
Display in the analyser.
declaration ("* indicates
declaration
research parameters and
cannot be used as the basis
for clinical diagnosis")
Print research parameters Click "Print Research Parameters" check box the
Display print obtained from counting
selected box will be marked with "√". Selected by
parameters results
default in the analyser.

Print research parameters Click "Print "*" Mark” check box and the selected
and need to print "*" mark
Print "*" mark box will be marked with "√". Selected by default
in the analyser.

Print research parameters Click "Print Declaration" check box the selected
and "*" mark and also need
Print declaration box will be marked with "√". Selected by default
to display declaration ("*
indicates research in the analyser.
parameters and cannot be

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Parameters Meanings Operations

used as the basis for


clinical diagnosis")
Click Apply to save settings of all items without
Apply Save settings
closing the Settings window.
Click OK to save settings of all items and close the
Ok Save settings
Settings window.
Click Cancel without saving any settings and close
Cancel Cancel settings
the Settings window directly.

 Basic operations
1. Set research parameters;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.

5.3.1.8 Gain
Used for gain adjustments. Not recommended for operator to make often adjustments.
Enter settings
Click Gain in General Settings to enter the Settings window.

 Parameter explanation

Parameters Meanings Operations

WBC WBC gain under whole blood Click the current cell value of "WBC" and input

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Parameters Meanings Operations

mode. new value of WBC gain adjustment.

RBC gain Click the current value cell of "RBC" and input
RBC
new value of RBC gain adjustment.
WBC gain under predilution Click the current cell value of "WBC(P)" and input
WBC(P)
mode new value of WBC(P) gain adjustment.
The purpose of adjusting HGB The operator can directly input the value in "HGB
HGB channel gain is to change the Current Value" edit box or click adjustment button
background voltage of HGB. to modify HGB gain.
Click Apply to save settings of all items without
Apply Save settings
closing the Settings window.
Click OK to save settings of all items and close the
Ok Save settings
Settings window.
Click Cancel without saving any settings and close
Cancel Cancel settings
the Settings window directly.

 Basic operations
1. Set gain value;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.

Note:

1. Gain for LAS, MAS and HAS can not be modified;

2. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.

5.3.1.9 Automatic maintenance


Enter settings
Click Automatic Maintenance in General Settings to enter Settings window.

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 Parameter explanation
Param
Meanings Operations
eters
Automatic sleep will start after Can be entered in "Waiting" edit box. The range is
Automatic the relevant operations of 15-120 minutes. The default is 15 minutes.
sleep fluidics system stop. Set the
waiting time.

Click Apply to save settings of all items without


Apply Save settings
closing the Settings window.
Click OK to save settings of all items and close the
Ok Save settings
Settings window.
Click Cancel without saving any settings and close
Cancel Cancel settings
the Settings window directly.

 Basic operations
1. Set automatic sleep time and scheduled maintenance time;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.

Note:

New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.

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5.3.2 User and password
When the operator logs in as the administrator, click Menu, select Settings and select User and Password in
the pop-up shortcut menu to bring up a dialogue box displaying the information list of all administrators and
users.

 Parameter explanation

Parameters Meanings Operations

Name Current user name In the box, enter


Login password of
Password In the box, enter
current user

Confirm password Confirm user password In the box, enter

Indicate current user In the box, enter


Comments
information

 Basic operations
(1) Add new users
1. Click Add and the user basic information column in grey will become white for editing.
2. Input all the information in each edit box of new user information;
3. Click Save to save the newly-added user information and refresh the personnel list without closing the
dialogue box; All field values input in the dialogue box will be emptied and the operator can continue to
add other new users.
4. If you want to exit "User and password", click other buttons in the menu item to switch to a
corresponding window directly.

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Note:

When adding users, user names cannot be duplicate or null.

(2) Delete users


1. Click the user cell to be deleted and then click Delete, and the following dialogue box will pop up;

2. Click Yes to delete the user, close the dialogue box and remove the deleted user from the personnel list;
3. If you want to exit from User and Password, click other buttons in the menu to switch to a
corresponding window directly.

Note:

The current login user cannot be deleted.

(3) Modification

The current login user can modify his/her password and the modification method is the same as
that of users.

(4) Emptying the password

The current login user can empty his/her password and the modification method is the same as that
of users.

5.3.3 Shortcuts
You can set shortcuts for the following items:departments, Deliverer, patient type, fee type, gender and
clinical diagnosis.

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If a short-cut code has been set, then when inputting or editing information, complete information will be
displayed by inputting the short-cut code of the corresponding items above and then pressing the [Enter] key.
This replaces inputting (or selecting) the complete information. It's a short-cut operation.

Note:

The shortcuts/ pinyin code for different items can be duplicated.

5.3.3.1 Department
When the operator logs in as the administrator, click Menu, select Shortcuts to bring up a dialogue box and
display short-cut code settings of department items by default.

 Basic operations
(1) Add new departments
1. Click Add and the colour of the shortcuts information column in grey will become white for editing.
2. Input all the information in each new department information edit box;
3. Click Save to save the newly added department information and refresh the personnel list without closing
the dialogue box; All field values input in the dialogue box will be emptied and the operator can continue to
add other new departments;
4. If you want to exit "Shortcuts", click other buttons in the menu item to switch to a corresponding window
directly.

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Note:

1. The names of new departments cannot be null or duplicated;


2. The corresponding pinyin code and short-cut code of the same department name can
be duplicated.
3. Shortcuts and short-cut pinyin codes can be null, but shortcuts or pinyin codes of
different departments that are not null cannot be duplicated.

(2) Delete departments


1. Click the department cell to be deleted and then click Delete, the following dialogue box will pop up;

2. Click Yes to delete the department, close the dialogue box and remove the deleted department from the
department list;
3. If you want to exit "Shortcuts", click other buttons in the menu item to switch to a corresponding window
directly.

5.3.3.2 Deliverer
Click Deliverer in the "Shortcuts" dialogue box to display the short-cut code setting of the submitted items.

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 Basic operations
Refer to the relevant contents of "Department" for the operation of adding, editing and deleting deliverer.

5.3.3.3 Patient type


Click Patient Type in "Shortcuts" dialogue box to display the short-cut code setting of the patient type items.

 Basic operations
Refer to the relevant contents of "Department" for the operation of adding, editing and deleting patient types.

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5.3.3.4 Clinical diagnosis
Click Clinical diagnosis in the "Shortcuts" dialogue box to display the short-cut code setting of clinical
diagnosis items.

 Basic operations
Refer to the relevant contents of "Department" for the operation of adding, editing and deleting clinical
diagnosis.
5.3.3.5 Gender
Click Gender in "Shortcuts" dialogue box to display the short-cut code setting of the gender items.

 Basic operations
Refer to the relevant contents of "Department" for the operation of adding, editing and deleting gender.

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Chapter 6. Daily Operations

6.1 Overview
This chapter introduces the process of daily operations from the start-up to the shutdown of the analyser.
It mainly describes the operation process of sample analysis under different work modes in detail.

Note:

The sequencing of turning on the analyzer or running the software is not prescribed.

The process of daily operation is as follows:

Preparation work

Contains analyzer and


Turn on analyzer operation software

Daily QC

Sample
preparation

Sample analysis

Exit software and turn


Turn off analyzer off analyzer

Figure 6-1 Process Diagram of Daily Operation

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6.2 Preparation before the operation
Before turning on the analyser power, the operator must perform the following requirements to ensure
that the system is ready.

Biological risk:

All items (samples, controls, calibrators, reagents, waste, etc.), and regions that these
items have contact with potential biological infection. Operators should observe
laboratory safety operation rules and wear personal protective devices (such as
laboratory protective clothing, gloves, mask, etc.) when touching relevant items and
regions in the laboratory.

Warnings:

1. Operators have an obligation to observe the relevant provisions of the region and
country when discharging and disposing expired reagent, waste, waste samples,
consumables, etc.
2. The reagent will cause irritation to eyes, skin and mucous membranes. Operators
should observe laboratory safety operation rules and wear personal protective
equipment (such as laboratory protective clothing, gloves, surgical mask, etc.) when
touching reagent-related items in the library.
3. If the skin is flyblowed by the reagent, please wash the affected area immediately
with plenty of water and seek medical treatment if necessary. If the reagent gets to
the eyes, please wash them immediately with plenty of water and seek medical
treatment from doctor.
4. Please take a distance to keep the clothes,hair or hands from getting hurt by the
moving assemblies.

Note:

1. The operator should use the reagents specified by the company, and store and use
them in strict accordance with the manual.
2. Before using the analyser, you should make sure the reagent is correctly
connected.
3. Position the reagent to stabilise before use it.

 Check the waste barrel


The operator should prepare his/her own waste barrel and make sure it is emptied before starting up
every day.
 Check the liquid pipeline and the power

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Make sure the pipelines of reagents and waste are not buckled and the connections are right;
 Make sure the analyser’s power plug is plugged in the power socket safely.
 Check the printer (optional)
Make sure there is plenty of paper for the printer and the installation is correct.
 Make sure printer’s the power plug is plugged in the power socket and the printer’s cable has been
connected to the external computer.
Keyboard, mouse, network cable and the external computer
Make sure the external computer’s network cable has connected with the analyser;
Make sure the keyboard and mouse electric cables have been connected with the external computer.

6.3 Boot up and user login


 Start the analyser:
Switch the "O/I" switch at the left side of the analyser to "I", the power light on.
 Ensure the state light on the analyser is on.
 Start the external computer and run the software:
1. Start the external computer;
2. Turn on the display;
3. After entering the operating system, run the LWD6500 software by doubling-click "LW D6500
Haematology Analyser" icon.

And the following login dialogue box will pop up:

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4. Input correct user name and password in the login dialogue box;
5. Click OK to start the initialization operation;

Note:

1. Make sure theexternal computer’s cable is connected with the analyser before
running the software. If not, the initialization operation will not be executed. It will
be executed until the connection between them has been detected.
2. If the software fails to run repeatedly, please contact our after-sales service
department or the agent.
3. Please confirm if the date/time on the computer of the equipment is consistent
with the actual date/time after the start-up has completed.
4. The initial user name and password of administrator are set by service engineers,
and they are "Admin" by default.
5. The input range of user name and password is 1-12 character(s). Chinese is not
allowed and the password can be blank.

6. During the initialization process, the corresponding start-up prompt information will be displayed in
the information prompt area at the bottom of the interface;
7. The whole start-up initialization process will last for approximately 4-12 minutes (depends on the
condition of last shutdown);

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8. After the initialization has completed, you can enter "Sample Analysis" interface to check the test
result of start-up background.

Note:

1. Background test is the measurement of the analyser for particle interference and
electrical interference.
2. If the first background result during fluidics initialization exceeds the normal
background, then the analyser will execute another background test (not yet achieved).
3. The corresponding sample ID of background test result is "0".
4. High, low or suspicious alerts will not be revealed in background test results.

5. If fault occurs during the initialization process (such asbackground test result exceeds
the normal background), the analyser will have an alarm message. Please refer to
Chapter 11 Failure Solution for the handling methods.
6. Please refer to Appendix A Specifications for the normal background of the
parameters.
7. The privilege of the operator as administrator or user is determined by the login user
name and password, and different functions on the interfaces will be granted according
to the user privilege.
8. If you want to switch users, please click Logout, input user name and password in the
login dialogue box and click OK to login to the software interface as a new user.
9. If test is performed while "abnormal background" failure occurs, unreliable test
results will be obtained.
10. The sequencing of turning on the analyser or running the software is not prescribed.

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6.4 Overview of worklist

Click on the shortcut button area or click Menu, and then select Worklist menu item to enter
the worklist interface.

 Parameter explanation
Param
Meanings Operations
eters
Sample ID Test sample ID Enter directly in the input box
Select either "Whole Blood" or
"Predilute" blood mode and "CBC" or
Mode Sample testing mode
"CBC+DIFF" measuring mode from the two
dropdown lists respectively.

The reference value range of the


Reference reference groups determines the Select the reference group of the sample from
group counting results and gives alarms for the "Reference Group" dropdown list.
the results that exceed normal range
Select sampling date from the date control
Draw time Sampling date
and input draw time in the time edit box.

Sample Select delivery date from date control and


delivery Delivery date
input sample delivery time in the time edit box.
time
Patient ID Patient ID Enter directly in the input box

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Param
Meanings Operations
eters
Name Patient's name Enter directly in the input box
Input patient's gender in "Gender" box or select
Gender Patient’s gender
from "Gender" dropdown list.
Select the inputting method for age as
"Year", "Month", "Day" or "Hour" from "Age"
Age Patient's age
dropdown list and input the patient's age in the
input box before age unit.

Date of Select patient's date of birth in date


Patient's date of birth
birth control

Input patient's type in "Patient's Type" box or


Patient type Patient type item
select from "Patient's Type" dropdown list.
Input type of charges in " Expenses Type"
Expenses
Expenses type item box or select from " Expenses Type" dropdown
type
list.

Input the department name for executing


sample in "Department" box or select from
Department Department item
"Department" dropdown list (when records
exist in the dropdown list).

Bed No Patient's bed No in hospital Enter directly in the input box

Enter the deliverer’s name in the "


Deliverer " box or select from the " Deliverer "
Deliverer Deliverer
dropdown list (when records exists in the
dropdown list).

Clinical Enter directly in the input box


Suspected diagnostic information
diagnosis

Comments Information required to be declared Enter directly in the input box

 Basic operations
The upper portion of the interface is the worklist while the lower portion is the information input area
including "Sample Information" and "Patient’s Information". The bottom of the interface is the functional
button area.

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Note:

1. The worklist can store 2,000 records in maximum.


2. The field information in the list is obtained from the information input area in
lower portion except for serial number, "Analysis Status" and "Input Time".
3. If the worklist is empty, all the information fields in the information input area
will be empty and greyed out.
4. If a record in the worklist is highlighted, the message input area will display the
messages that are consistent with that of the highlighted record.

The following operations can be performed in the worklist on the upper portion of the
worklist interface:
(1) Adjust the column width

Click and drag the separation line between columns to adjust the column width.

(2) Adjust the record position


1. Right-click the highlighted record and the following shortcut menu will pop up;
2. Click Top to place this record as the first record in the worklist;
3. Click Up to move the current highlighted record before the immediate previous record; that is, to
exchange the position with the immediate previous record;
4. Click Down to move the current highlighted record after the immediate next record; that is, to
exchange the position with the immediate next record;
5. Click Bottom to place the current highlighted record as the last record in the worklist;
If the operator clicks and highlight a record in the worklist, then the message input area in lower portion
will display the messages which the operator can edit are consistent with that of the highlighted record.

Note:

The "Sample ID" and "Mode" in the information input area cannot be edited while
the record’s "Analysis Status" is “Analysing”.

(3) Add
1. Click Add and a new record will be added at the bottom of the worklist, and this blank record will be
highlighted in the list;
2. Input sample/patient’s information in the information input area and click Save directly;
3. Click Start Counting and press Sample Absorption on instrument to start counting.

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Note:

1. The analysis status of the newly-added record is "To be Analysed".


2. Use [Tab] key to switch among the options in the sample information/patient’s
information area. After setting according to "General Settings" section in Chapter 5
Settings, you can also use [Enter] key to switch.
3. When switching options with [Tab] key or [Enter] key, you can skip some options
that are not necessary to be input. For the setting method, please refer to "General
Settings" section in Chapter 5 Settings.

Note:

1. Letters, numbers and all characters supported on the keyboard are allowed to be
input in sample ID (including special characters).
2. The sample ID’s allowed length range is [1-20], and it cannot be blank.
3. The ending character of sample ID must be a number, but the sample ID cannot be
all "0".

4. "CBC" measuring mode is for counting only and WBCs will not be classified. The
counting results include 14 parameters and the histograms of WBC, RBC and
PLT;"CBC+DIFF" measuring mode is for counting and the five-differential of
WBCs. The counting results have 24 parameters, differential scattergram, the
histograms of WBC/BASO, RBC and PLT, and 4 research parameters.

5. If the operator has input patient's gender and age, then the system will match the
reference group according to the corresponding relationship automatically.
6. If the matched reference group is not consistent with the reference group
previously selected by the operator (except for the 5 user-defined reference groups),
then the automatically matching reference group will be used.
7. Delivery date/time cannot be earlier than sampling date/time.
8. Sampling and delivery date/time cannot be later than the current system date/time.
9. The age will be calculated automatically according to the difference of "Current
System Date" and "Date of Birth" after entering the date of birth, and the
newly-calculated age value and unit will be displayed in the age value edit box and
unit combo box. The age edit box will be reactivated from greyed out after clearing
the "date of birth".

10. If the date of birth entered is later than the current system date, then the date of
birth will be recognized as invalid.

11. "Sample No + Mode" of the current record cannot be the same as the unblocked
records with "To be Analysed", "Analysing" or "Error" status.


(4) Insert
1. Click a record in the worklist to highlight it;

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2. Click Insert to insert a new record before the highlighted record. The inserted blank row will be
highlighted. Fields in the information input area will display in default values and are activated;
3. Input sample/patient's information in the information input area and click Save directly.
(5) Save
After the operator has edited/added/inserted the record information, click Save directly to save all the
current information.

Note:

"Sample No + Mode" of the current record cannot be the same as the unblocked
records with "To be Analysed", "Analysing" or "Error" status.

(6) Delete
1. Click Delete and the delete dialogue box will pop up;

2. Click Selected Records, All Completed Records or All Records radio button to select the records
need to be deleted."Selected Records" are records with "√" selected in the worklist;
3. Click OK and the prompt dialogue box will pop up;

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4. Click OK to perform deletion operation and refresh the worklist.

Note:

Records which the "Analysis Status" is “Analysing” cannot be deleted.

(7) Enquire
1. Click Enquire and the enquire dialogue box will pop up;

2. Select one or more options as the enquiry conditions;


3. Enter the contents to search for in the options edit boxes as the enquiry conditions.
1 If you want to perform precise search according to the contents entered, please select "Perfect Match"
check box; If you want to perform fuzzy query according to the selected enquiry conditions (that is, to search
for the related records of the contents input in the edit box), then let the item unchecked;

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2 Click Find Previous/Find Next to search upward/downward from the currently highlighted record.
The records will be highlighted if they meet the criteria. Click Find Previous/Find Next to continue
enquiring;
3 A round of enquiry will end when it returns to the beginning record. If there is no record that meets
the criteria, "No matching record!" prompt dialogue box will pop up on the interface; Otherwise "Finished
enquiring all records!" prompt dialogue box will pop up on the interface. Click OK to close the prompt
dialogue box;
4 If you want to enquire for other contents, please repeat steps 2-6 to continue enquiring; If you want to
stop enquiring, click Close to close the enquiry dialogue box.

Note:

If the first/last record of the worklist has been reached, it will go back to the last/first
record of the worklist and continue the next cycle of enquiry upward/downward.

(8) Copy
1. Click a record need copied in the worklist to highlight it;
2. Click Copy, a new record is added in the worklist and highlighted;
3. The sample ID will be blank or added 1 to the newly-input sample ID in the worklist. Other
information will be consistent with the copied records.

(9) Block
1. Select the corresponding check box of a sample record in the worklist;
2. Click Block to block and grey out the selected record.

Note:

1. Click Block to block all the selected records includes blocked or unblocked
ones.

2. Cannot block records where "Analysis Status" is “Analysing” or "Completed".

3. You can edit or delete blocked records.

(10) Unblock
1. Select the corresponding check box of a blocked sample record in the worklist;
2. Click Unblock to unblock and grey out the selected record.

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Note:

If the selected records are blocked, "Block" button will change to "Unblock" button.

6.5 Daily QC
QC analysis is required to be performed on the analyser every day before performing sample analysis to
ensure reliable analysis results. Please refer to Chapter 8 QC for the specific operation methods of QC
analysis.

6.6 Preparation of samples

Biological risk:

All items (samples, controls, calibrators, reagents, liquid, etc.) and regions that have
contact with these items have the potential biological infection. Operators should
observe laboratory safety operation rules and wear personal protective devices (such
as laboratory protective clothing, gloves, mask, etc.) when touching relevant items or
regions in the laboratory.

Warnings:

Do not touch patients' blood samples directly.

Cautions:

Do not use disposable items repeatedly.

Note:

1. The operator should use clean K2EDTA anticoagulation vacuum cuvettes,


siliconized glass/plastic cuvettes, centrifuge tubes and silicon-boronated glass
capillary cuvettes.
2. The operator must use disposable items specified by the company, such as vacuum
blood collection tubes, centrifuge tubes, capillary tubes, etc.

6.6.1 Whole blood sample


1. Use K2EDTA (1.5 - 2.2mg/mL blood) anticoagulation vacuum tube to collect venous blood samples.

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2. Mix the venous blood and anticoagulant in the tube adequately and rapidly.

Cautions:

For vacuum tube of specification Ф12X75 (excluding the tube cover size), ensure
that the quantity of the whole blood sample is not less than 0.5mL.

Note:

1. Samples that are needed to perform WBC classification or PLT counting should be
kept at room temperature and should be analysed within 8 hours after collection.

2. If analysis results of PLT, MCV and WBC classification are not required, they can
be stored in the refrigerator at 2℃ - 8℃ for 24 hours. Refrigerated samples can
only be used to perform analysis after being at room temperature for at least 30
minutes.

3. Samples that have been laid for a period of time need to be mixed again before
analysis.

6.6.2 Prediluted sample


1. Click Add Diluent in the shortcut button area and the following prompt box will pop up;

2. When the preparation is completed, the following dialogue box will pop up;

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3. Take a clean centrifuge tube. Insert the probe vertically to the bottom of the centrifuge tube after
opening the cover as shown in the following figure to avoid producing bubbles, suspending liquid and
spilling while adding diluent;

4. Press the sample aborption key to add diluent, the interface will pop up the progress prompt box of
adding diluent;

5. When the addition of diluent is completed the buzzer rings and the interface will pop up following
dialogue box. And the user then can move the centrifuge tube away;

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6. Collect 20μL Peripheral blood and rapidly inject it into a centrifuge tube with diluent inside, and then
put the cover on and mix them;
7. After preparation of the prediluted sample, click Cancel to exit the operation of adding diluent;

8. After the exit operation, the prompt dialogue box mentioned above will close automatically;
9. If you need to prepare more diluent, repeat steps 3 - 5.

Note:
1. Operators can also absorb 180μL diluent with a transferpettor.
2. In the preparation progress before adding diluent, the diluent absorbed are just
enough for 20 times, so after preparing 20 shares of diluent, preparation for adding
diluent will be performed again.
3. You should avoid dust while preparing diluent, otherwise analysis errors may
arise.
4. After the peripheral blood fully reacts with the diluent, it needs to be laid for 3
minutes, and then mixed again before analysis.
5. Ensure to perform analysis in 30 minutes after the sample dilutied, otherwise the
analysis result will be unreliable.
6. Samples that have been laid for a period of time need to be mixed again before
analysis.
7. Every laboratory should evaluate the stability of sample analysis results under
predilution blood mode for the number of samples, sample collecting methods and
technical levels.

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6.7 Sample analysis

6.7.1 Enter worklist information


Operators can enter samples’s worklist information before analysis.

Note:

1. Abnormal shutdown will cause unsaved sample information in the worklist to be


lost.
2. If the operator wants to enter complete worklist information after analysis, please
refer to Chapter 7 Results Review.

Click on the shortcut button area or click Menu, and then select Worklist menu item to enter
the worklist interface.

Newly adding sample record function. Please refer to section " Worklist Overview" in this chapter for
detailed steps.

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6.7.2 Steps of sample analysis

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that have
contact with these items have the potential biological infection. Operators should
observe laboratory safety operation rules and wear personal protective devices (such as
laboratory protective clothing, gloves, mask, etc.) when touching relevant items and
regions in the laboratory.

Warnings:

The probe head is pointed and sharp. Blood samples, controls and calibrators that have
come into contact with the probe have potential biological infection risks. Avoid
touching the probe.

Cautions:

Do not use disposable items repeatedly.

Note:

1. While the probe is absorbing sample, the probe head should keep a certain distance
with the bottom of the container; otherwise it will affect the accuracy of the absorbed
amount.
2. The test tube wall should avoid contacting with the probe head since this will cause
blood to splash downward.

3. You need to select appropriate parameter reference value scopes on the "Setting"
interface before sample analysis; otherwise you may not get the correct alarm prompt
after finishing the sample analysis.

4. If blood mode switches from "predilution blood" to "venous whole blood" or


"peripheral whole blood", the analyser will execute mode switch fluidics sequence
automatically and display the progress bar prompt on the interface.

5. If the last completed sample is under the venous whole blood mode, and the next
sample to be analysed is under predilution blood mode, the interface will display the
prompt dialogue box: "The mode of the next sample is predilution blood mode!"
automatically.

6. If the worklist is empty, perform counting directly. The default mode is the same
with the last sample. The default mode is "whole blood - CBC+DIFF" at first.

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6.7.2.1 Whole blood sample analysis

1. Click shortcut button to enter the sample analysis interface. select "vein whole blood" in the
blood mode tab.

2. Shake the whole blood sample as shown in the following figure to fully mix the sample;

3. Put the whole blood sample under the probe to allow the probe to absorb the mixed sample;
4. Press the instrument’s counting button to start the sample analysis procedure;
5. The probe absorbs the sample automatically. The operator can move the sample away when the buzzer
rings. The analyser performs sample analysis automatically. At this time, the status icon and the green light of
state lights flicker, and the content in the "Next Sample" information tab updates automatically;
6. Status icon and state lights recover to green after analysis;
7. Perform analysis for other samples according to this process.
6.7.2.2 Peripheral whole blood sample analysis
1. Take about 20μl of peripheral blood and fully mix it;

2. Click shortcut button to enter the sample analysis interface. select "peripheral whole
blood" in the blood mode tab. The method is the same with "Venous whole blood sample analysis".
6.7.2.3 Predilution sample analysis

1. Click shortcut button to enter the sample analysis interface. select "predilution blood" in the
blood mode tab.
2. Shake the predilution sample with the tube cover firmly fixed on to fully mix the sample;

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3. Open the tube cover of the predilution sample carefully and put the predilution sample under the
probe to allow the probe to absorb the mixed sample;
4. Press the counting button to start the sample analysis procedure;

Note:

The prompt dialogue box before predilution counting will not pop up after setting.
Please refer to section "General Settings" in Chapter 5 Setting for the setting
methods.

5. The probe absorbs the sample automatically. The operator can move the sample away when the buzzer
rings. The analyser performs sample analysis automatically. At this time, the status icon and the green light of
state lights flicker, and the content in the "Next Sample" information tab updates automatically;
6. Status icon and state lights recover to green after analysis;
7. Perform analysis for other samples according to this process.

Note:

1. One is allowed to perform all the operations such as adding, editing or deleting on
other samples which are to be analysed or have errors in the worklist during analysis
procedure.

2. Browsing data, reviewing, editing sample information or printing on list review or


graph review interfaces during the analysis process are allowed, so as switching to
other interfaces.

3. Other related functions of fluidics system fluidics sequence are not allowed to be
performed during the analysis process.

4. If the current interface is not the graph review interface, the latest record’s
information, results and graph will be refreshed and displayed when the operator
switches to the graph review interface.

6.7.3 Handling analysis results


6.7.3.1 Saving analysis results
Analyser can save the analysis results automatically. When the number of sample results has reached the
upper limit of storage, new sample analysis results will automatically overwrite the oldest and backed up
sample analysis results. Upper limit of storage for the number of sample results is 100,000.
6.7.3.2 Parameter alarm
1. "↑" or "↓" displayed on the left of parameter results indicate that the analysis results have exceeded
the pre-set parameter reference value range but are still within the display range;
2. "?" displayed on the left of parameter results indicate that the analysis results are questionable;

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3. Analysis results displayed as "***" indicate that the measuring results are invalid or have exceeded
the display range.

Note:

The analyser will not perform parameter alarm, classification or morphological


abnormality alarm for background test results.

6.7.3.3 Classification or morphological abnormality alarm


The analyser will perform abnormality or questionable alarm for WBC, RBC and PLT according to
scattergrams and histograms. The definitions of prompt information are as shown in the following table.

Information type Flag prompt information

WBC abn. scattergram

WBC histogram abn.

Abnormal WBC

Leucocytosis

Leucopenia

Neutrophilia
Abnormal
Neutropenia

Lymphocytosis
WBC
Lymphopenia

Monocytosis

Eosinophilia

Basophilia

Left shift?

Immature cell?
Questionable
Abn./Atypical Lym?

RBC lyse resist?

Erythrocytosis
RBC/HGB Abnormal
RBC distribution abn.

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Anisocytosis

Macrocytosis

Microcytosis

Dimorphologic

Anaemia

Hypochromia

Questionable Haemoglobin abn./interfere?

PLT Distribution abn.

Abnormal Thrombocytosis
PLT
Thrombopenia

Questionable PLT clump?

The analyser will perform abnormality or questionable alarm for WBC, RBC and PLT according to
scattergrams and histograms. Its influence on parameter results is as shown in the following table.

Whole blood Predilution

Category Alarm name


CBC+ CBC+
CBC CBC
5DIFF 5DIFF

Abnormal WBC × √ × ×

RBC lyse resist? × √ × ×

WBC abn. scattergram × √ √ √

WBC histogram abn. × √ √ √

Left shift? × √ × ×
WBC
Immature cell? × √ × ×

Abn./Atypical Lym? × √ × ×

Leucocytosis √ √ √ √

Leucopenia √ √ √ √

Neutrophilia × √ × ×

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Neutropenia × √ × ×

Lymphocytosis × √ × ×

Lymphopenia × √ × ×

Monocytosis × √ × ×

Eosinophilia × √ × ×

Basophilia × √ × ×

Dimorphologic √ √ × ×

Haemoglobin abn./interfere? √ √ × ×

Anisocytosis √ √ × ×

Microcytosis √ √ √ √

RBC/HGB Macrocytosis √ √ √ √

Erythrocytosis √ √ √ √

Anaemia √ √ √ √

Hypochromia √ √ √ √

RBC distribution abn. √ √ × ×

PLT clump? √ √ × ×

Thrombocytosis √ √ √ √
PLT
Thrombopenia √ √ √ √

PLT Distribution abn. √ √ × ×

Note:

Microscope is recommended when the PLT counting is less than 100  109 / L.

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6.8 Shutdown

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
have contact with these items have the potential biological infection. Operators
should observe laboratory safety operation rules and wear personal protective
devices (such as laboratory protective clothing, gloves, mask, etc.) when touching
relevant items and regions in the laboratory.

Warnings:

The probe is sharp and may be stained with biologically contaminated materials.
Please be careful when operating the analyser. Do not touch the probe.

Note:

1. To ensure the stability of the analyser and the accuracy of analysis results,
please execute the shutdown operation as required after the analyser has been
running for 24 hours.
2. Operators should perform normal shutdown procedures to shut down according
to the steps below.

Shutdown includes two sections: Shutting down the analyser and exiting the software. The procedures
for "shut down the analyser" and "exiting software system" will be introduced separately below.
 Shut down the analyser

1. Click in the shortcut button area and the following figure will pop up:

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2. Click the icon or select Menu  Instrument  Shutdown Instrument menu item and
the following dialogue box will pop up;

3. Click Yes and the following prompt dialogue box will pop up;

4. Press the counting button to start absorbing immersion solution. The interface will prompt the
progress during the immersion solution absorption process;

5. The progress bar dialogue box will close automatically and the prompt dialogue box will pop up at the
same time;

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6. Press the counting button to start absorbing immersion solution. The interface will prompt the
progress during the immersion solution absorption process;

7. The progress bar dialogue box will close automatically and the prompt progress bar for 5 minutes of
probe cleanser soaking will pop up at the same time;

When the progress bar dialogue box closes automatically, the instrument will automatically perform
cleaning.
8. Probe immersion will be finished after 5 minutes of immersion. The corresponding shutdown prompt
information will be displayed in the information prompt area at the lower portion of the interface during the
shutdown process;
9. The following prompt dialogue box will pop up when the instrument has finished exectuting the
fluidics sequence of fluidics system shutting down;

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10. Switch the "O/I" switch on the left side of the analyser to "O" and this dialogue box will close
automatically;
11. Empty the waste in the waste barrel and handle the waste properly after shutting down.

Warnings:

Operators have an obligation to observe the relevant provisions of the region and
country when discharging and disposing of expired reagent, waste, waste samples,
consumables, etc.

Note:

1. The shutdown operation of the instrument will not be executed if the analyser
and the computer are not connected.
2. Do not shut down the instrument forcibly while counting or other fluidics system
fluidics sequence is running.

3. If failure affecting shutdown occurs during the shutdown process, the analyser
will return to the status before shutdown and prompt an alarm. Please refer to
Chapter 11 Troubleshooting for the troubleshooting methods.

4. If Restart is clicked, the analyser will start again and perform initialization.

5. The software will not exit after the analyser has shut down. Users can still
perform operations that are not related to the analyser.

Exiting software system


1. Click Exit System yellow key in the shortcut button area and the following dialogue box will pop up.

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2. Click the icon to perform shutdown process. The entire software system will exit
automatically when the process has been completed.

Note:

You can only exit the software of the computer end after shutting down the
instrument of the analyser end.

Shut down the external computer


1. Shut down the external computer according to the shutdown process of the operating system;
2. Shut down the display.

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Results review

Chapter 7. Results review

7.1 Overview
The analyser will store sample information, result data, Flag prompt information, histograms and
scattergrams in the review database automatically after each sample analysis. The sample library of the
analyser can store up to 100,000 sample records.
Operators can review sample information, result data, Flag prompt information, histograms and scattergrams
saved in the review database in the form of graph or list in graph review interface or list review interface.

7.2 Graph review

Click in the shortcut button area (click the icon button to switch between graph review and list
review interfaces) or click Menu and select Review  Graph Review in the pop-up menu to enter the graph
review interface as shown in the figure below.

The graph review interface is composed of 4 sections. Sample/patient's information is displayed in the upper
portion of the interface while result data, scattergram, histogram, alarmFlag, DIFF diagram, microscopy
result and blood type/RSR rate result of the sample corresponding to the sample/patient’s information are
displayed in the lower portion of the interface in the format of "Graph/Data", "DIFF", "Others" and
"Research" tabs. The functional buttons available in the interface are displayed at the bottom of the interface.

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7.2.1Sample/patient's information
Operators can browse sample records one by one by using the record switching bar on the lower right of the
interface.
Sample/patient’s information of records can be checked in the upper portion of the interface. Operators can
directly edit patient’s information except for sampling mode, blood mode, analysis mode, verification,
operator and proving time. Please refer to the relevant contents of "Enter Worklist Information" section in
Chapter 6 Daily Operations for the operations of the related information editing.

Note:

1. Normal users can edit sample IDs, in "Settings". Please refer to Chapter 5 Settings
for specific details.

2. Operators are allowed to edit sample information except for sampling mode blood
mode, analysis mode, verification, operator and proving time.

7.2.2 Tab
The corresponding information can be checked in the tab at the bottom of the interface after selecting a
sample record.

7.2.2.1 Data/Graph
Click Data/Graph tab in the interface to check data/graph information of the record.

A magnifying glass icon will appear when the mouse cursor moves over any graph in the histograms.
Operators can click this graph with a pop-up dialogue box where the operators can drag the Enlarged
Drawing dialogue box freely.
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Operators can click "╳" on the upper right of the dialogue box to close it after browsing.

Note:

You can select whether to display 4 research parameters, "*" marks and related
declarations ("*" indicates research parameters, cannot be used as basis for clinical)
in "Settings". Please refer to Chapter 5 Settings for specific details.

 Basic operations

(1) Save

Click Save to save all modified information in all tabs of the current sample.
(2) Print

Click Print to print the information, result data, histograms and scattergram of the current
sample.
(3) Delete

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1. Click Delete and the delete confirmation dialogue box will pop up;

2. Click OK to delete the sample record displayed in the current graph review interface.

Note:

Delete is not visible to users and the deletion operation cannot be performed.

(4) Verification

Click Verification to perform the verify operation.

Note:

1. Users can be authorized with verify privilege in "Settings"; otherwise, the users
will need to perform privilege authentication by entering administrator's user name
and password.

2. Sample/patient's information and inspection results are not allowed to be


modified after verifying.

(5) Cancel

Click Cancelto cancel the verify operation.

Note:

1. If the current sample has been verified, then Review will change to Cancel.

2. If the "Verification" privilege is open to users in "Settings", then the "Cancel"


privilege is also open to users by default. Otherwise, the users will need to perform
privilege authentication by entering administrator’s user name and password.

3. The sample/patient's information and inspection results will be unlocked after


cancelling the verification.

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(6) Edit results
1. Click Edit and the edit boxes of the results of measurement parameters will be activated. Operators can
modify the results directly in the edit boxes;
2. After the results have been modified, click Save to save them. The edit boxes of the results will then
disappear automatically.

Note:

1. Uses can be authorized with the privilege to edit results in "Settings"; otherwise, the
users will need to perform privilege authentication by entering administrator’s user name
and password.

2. If the result data of a measurement parameter has been modified, then the result value
of the corresponding parameter will also be changed and high/low questionable alarm
will be applied according to the modified results.

3. Only the results of measurement parameters (WBC, RBC, HGB, MCV and PLT) can
be modified.

4. If the results have been edited, then the manually modified parameter’s results will be
marked with "E" after them no matter whether the sample has been verified or not. As
some parameter’s results have been manually modified, the modified result data of the
corresponding parameter’s results will be marked with "e" ("E" or "e" marks will be
displayed between the result data and the parameter’s units).

(7) Recover results


1. Click Recover and a prompt dialogue box will pop up;
2. Click OK to recover the results of each parameter to the original measured values of the analyser and
remove the marks ("E" or "e") resulted from the execution of "Edit".

Note:

1. If the "Edit Results" privilege is open to users in "Settings", then the "Recover"
privilege is also open to users by default. Otherwise, the users will need to perform
privilege authentication by entering administrator’s user name and password.

2. The instrument can only save the latest 100,000 original measurement results of the
modified samples.

7.2.2.2 DIFF
Click DIFF tab in the interface to check WBC classification information of each record.

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A magnifying glass icon will appear when the mouse cursor moves over any graph in the histogram.
Operators can click this graph with a pop-up dialogue box where the operators can drag the Enlarged
Drawing dialogue box freely.

Operators can click "╳" on the upper right of the dialogue box to close it after browsing.

Note:

1. DIFF tab will be greyed out and cannot be browsed if the analysis mode is CBC.

2. You can select whether to display the 4 research parameters, "*" marks and related
declarations ("*" indicates research parameters, cannot be used as basis for clinical) in
"Settings". Please refer to Chapter 5 Settings for specific details.

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 Basic operations

Refer to the basic operations in the "Data/Graph" section in the chapter for specific details about editing or
recovering result data.

7.2.2.3 Microscopy and others


Click Others tab in the interface to check and enter the microscopy, blood type and RSR rate information of
the sample.

 Parameter explanation

Parameters Meanings Operations

Click Category of Microscopy Sample combo box and select


Microscopy Category of Venous Blood or Peripheral Blood as the category of
sample microscopy sample microscopy sample. The default category of microscopy sample
is "Venous Blood".

Click the edit box of "Microscopy Time" and enter date and time
Micro.Time Microscopy time
of microscopy.

Describe cellular Directly enter the morphological information of each cell in the
Microscopy
morphologies of
description box
WBC, RBC and PLT.

Cell The percentages of each classified cell in the edit boxes can be
Cell Classification
Classification entered after the names of the 22 categorized cells respectively.
Select the patient's blood type in "Blood type/ESR" bar. Select
"Blank", "A", "B", "O" or “AB" in the first combo box after
Blood type Patient's blood type
clicking blood type, and select "Blank", "RH+" or "RH-" by
clicking the second combo box.

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Parameters Meanings Operations

1. Click Set ref. scope, and the following dialogue box will pop
up. Enter the lower limit and the upper limit of the reference
value of RSR rate in the "Lower limit" and "Upper limit" edit

If the measured value


of RSR rate has
exceeded the
reference value range,
RSR rate
it will be prompt with
"↑" or "↓", indicating
that the RSR rate
value is high/low.

boxes:

2. Click OK to save the settings and refresh the interface


information.

Note:

1. Microscopy time cannot be greater than the current system time.

2. The value range of cell classification entered is [0.0-100.0] and the unit is "%".

3. RSR rate information: The upper and lower limit range can be entered is [0, 999] and
only one to three digit number can be entered. The upper limit cannot be less than the
lower limit; The reference range of ESR results for each sample is only effective to that
result, and the default reference range is [0, 20].

 Basic operations
Refer to the basic operations in the "Data/Graph" section in the chapter for specific details about editing or
recovering result data.

Note:

1. In the Settings, you can set copies of the printing report.

2. In the Settings, you can select whether to print Flag prompt information when printing
reports.

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7.2.2.4 Research
Click Research tab in the interface and then you can check the specific value of each parameter result.

Note:

1. Specific value for parameter results that have exceeded the display range or with no
collected data cannot be given.

2. Editing the result of "Data/Graph" tab does not affect displaying each parameter of
"Research" tab.

3. The content of this tab is for research and checking only and cannot be edited or
printed.

7.3 List review

Click in the shortcut button area (you can switch between the graph review and list review
interfaces by clicking the icon button) or click the "Menu" button, and select "Review" "List review" in the
menu that pops up to enter the list review interface shown in the figure below.
The list review interface is composed of 3 parts. The upper area of the interface contains sample records
presented as a list while the lower area thereof contains sample results data, complete sample information and
patient information, microscopy results and blood type/RSR rate results corresponding to the current sample
record. Function buttons available in the interface are displayed on its uppermost side and lowermost side.

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7.3.1 Sample record
You can browse each sample record and its main sample/patient’s information in the list review interface.

Note:

1. For sample result with errors, the content of each information field will be
displayed in red.

2. For a printed sample, the relevant cell of the "Print" column will be displayed as
"P"; For an unprinted sample, the relevant cell of the "Print" column will be displayed
as blank.

3. For a verified sample, the relevant cell of the "Verification" column will be
displayed as "V"; For an unverified sample, the relevant cell of the "Verification"
column will be displayed as blank.

You can execute the following operations in the sample record list area:
(1) Select sample list
Click Sample list combo box and select "Samples within today", "All Samples" or "Query result". The
default option for "Sample list" is "Samples within today".
The records displayed in the review list will be different if you select different options, and the relationship
between the two is shown as follows:
Record option Record displayed in the list

Samples within today Only displays today's sample records

All samples Display all sample records stored in the sample library

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Query result Display all sample records that meet the query conditions

(2) Interface jump


Double click the record in certain row of the list, and then the interface will automatically jump to its
graph review interface.

7.3.2 Tab
The corresponding information can be checked in the tab at the bottom of the interface after selecting a
sample record.

7.3.2.1 Result data


Click Result tab in the interface, and then you can check each parameter result data of the current highlighted
record in the list.

Note:

You can select whether to display 4 research parameters, "*" marks and related
declarations ("*" indicates research parameters, cannot be used as basis for clinical)
in "Settings". Please refer to Chapter 5 Settings for specific details.

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 Basic operations

(1) Save

Click Save to save all modified information in all tabs of the current sample.
(2) Print

Click Print to print the information, result data, histogram and scattergram of the current sample.
(3) Delete

1. Operators can select the sample record to be deleted with "√";


2. Click Delete and the delete confirmation dialogue box will pop up;

3. Click OK to delete all selected records in the list.

Note:

Delete is not visible to users and the deletion operation cannot be


performed.

(4) Query

Operators can search specified sample records in the current operation list. The searched
record scope is always within all sample records.

1. Click Query, and the enquire combo box shown below will pop up.

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2. Operators can confirm the query conditions according to requirements.
Parameter explanation

Parameters Meanings Operations

Click the check box in front of "Sample ID" which will then
Sample ID Query Sample ID turn into "√" state and enter the sample ID in the "Sample
ID" box.

Click the check box in front of "Name" which will then turn
Name Query patient’s name
into "√" state and enter the patient's name in the "Name" box.

Click the check box in front of "Proving date" which will


Proving date Query proving date then turn into "√" state and select the upper limit and lower
limit of the Proving date.

Click the check box in front of "Gender" which will then turn
Query patient's
Gender into "√" state and click Male, Female or Blank radio button
gender
to select the patient's gender.

Patient ID Query patient's ID Click the check box in front of "Patient ID" which will then
turn into "√" state and enter the patient's ID in the "Patient ID

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Parameters Meanings Operations

" box.

Click the check box in front of "Department" which will then


Query patient's
Department turn into "√" state and enter the department name in the
department
"Department" box.

Click the check box in front of " Bed No." which will then
Query patient's bed
Bed No. turn into "√" state and
number
enter the patient's bed number in the " Bed No." box.

Query deliver's Click the check box in front of "Deliverer" which will then
Deliverer turn into "√" state and enter the name of the person who
number
submitted the inspection request in the "Deliverer " box.

Query sample Click the check box in front of "Verification" which will then
Verification turn into "√" state and click Verified or Not verified radio
verification state
button to select the verification state.

Query sample Click the check box in front of "Printing state" which will
Printing state then turn into "√" state and click Printed or Not Printed
printing state
radio button to select printing state.

Click the check box in front of "Communication" which will


Query sample then turn into "√" state and click Communicated or Not
Communication
communication state communicated to select communication state (Not supported
temporarily).

1. Click the check box in front of "Perfect" to turn it into "√"


state, and the precise query will be performed according to
the selected query conditions; Otherwise, fuzzy query will be
performed according to the selected query conditions (that is,
Query other to search for the related records of the contents input in the
Option information of the edit box);
sample option
2. Click the check box in front of "Case sensitive" to turn it
into "√" state, and the record will be searched according to
the different case of contents entered in the edit box;
Otherwise, it will be considered as case sensitive, (i.e. not
case sensitive).

3. Click OK to execute query operation according to the query conditions and then automatically switch to
"Query Result" list in "List Review" to display all query records.

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Note:

The range of searched records is always within all sample records.

(5) Verification

Click Verification to verify the highlighted record in the current list.

Note:

1. Users can be authorized with verify privilege in "Settings"; otherwise, the users
will need to perform privilege authentication by entering administrator's user name
and password.

2. Sample/patient's information and inspection results are not allowed to be modified


again after verifying.

(6) Batch verification

Click Batch Verification and a dialogue box as shown below will pop up;

1. Click Checked Records or Specify Record to select records that require batch verification. "Checked
Records" are records selected with "√" in the review list;

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2. If "Specify record" radio button is clicked, then the specified start and end proving date that require batch
verification will be performed;
3. Click OK to execute batch verification operation.

Note:

1. If the "Verfication" privilege is open to users in "Settings", then the "Batch


Verfication" privilege is also open to users by default. Otherwise, the users will need to
perform privilege authentication by entering administrator’s user name and password.

2. Sample/patient's information and inspection results are not allowed to be modified


again after the records have been verified.

3. Batch verification records can be verified records.

4. You can choose whether to automatically remove the "√" marks in front of the
verified records.

(7) Cancel

Click Cancel to cancel the review operation.

Note:

1. If the current highlighted record has been verified, then Verification button will
change to Cancel.

2. Cancel Verification is for the highlighted records in the list only.

3. If the "Verification" privilege is open to users in "Settings", then the "Cancel"


privilege is also open to users by default. Otherwise, the users will need to perform
privilege authentication by entering administrator’s user name and password.

4. You can choose whether to automatically remove the "√" marks in front of the
verified records.

5. The sample/patient's information and inspection results will be unlocked after


cancelling the verification.

(8) Edit result

1. Click Edit and the inspection data edit box corresponding to each test parameter in "Result" tab will be
activated. Operators can directly modify the results in the edit box;
2. After the results have been modified, click Save to save them.

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Note:

1. Users can be authorized with the privilege to edit results in "Settings"; otherwise,
the users will need to perform privilege authentication by entering administrator’s user
name and password.

2. If the result data of a measurement parameter has been modified, then the result
value of the corresponding parameter will also be changed and high/low questionable
alarm will be applied according to the modified results.

3. Only the results of measurement parameters (WBC, RBC, HGB, MCV and PLT)
can be modified.

4. If the results have been edited, then the manually modified parameter’s results will
be marked with "E" after them no matter whether the sample has been verified or not.
As some parameter’s results have been manually modified, the modified result data of
the corresponding parameter’ results will be marked with "e" ("E" or "e" marks will be
displayed between the result data and the parameter’s units).

(9) Recover result


1. Click Recover and a prompt dialogue box will pop up;

2. Click OK to recover the results of each parameter to the original measured values of the analyser and
remove the marks ("E" or "e") resulted from the execution of "Edit".

Note:

1. If the "Edit" privilege is open to users in "Settings", then the "Recover" privilege is
also open to users by default. Otherwise, the users will need to perform privilege
authentication by entering administrator’s user name and password.

2. The instrument can only save the latest 100,000 original measurement results of the
modified samples.

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(10) Tendency chart
Operators can check the tendency chart of the selected sample results.
1. Operators can select the sample results with "√";
2. Click Tendency Chart. The system will automatically calculate Mean, SD, CV% and deviation limit, and
the calculated result dialogue box will pop up as shown below;

3. Click Close to exit after browsing.

Note:

1. Operators can check the tendency chart only after selecting at least 3 sample
records.

2. The maximum number of selected records is the number of all records in the
review list.

3. There is no restriction for the sample records selected in the tendency chart as
long as they are the records in the review list.

(11) CV
Operators can check the reproducibility values of each parameter of the selected sample results.
1. Operators can select the sample records used in the reproducibility calculation with "√";
2. Click CV. The system will automatically perform repeatability calculation and the calculated result
dialogue box will pop up as shown below;

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3. Click Calc Deviation and a dialogue box will pop up as shown below. Operators can check the absolute
deviation values of the percentages of the 5 WBC classification parameters;

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4. Click Close to exit after browsing.

Note:

1. Operators can perform repeatability calculation only after selecting at least 3 sample
records.

2. The maximum number of selected records is the number of all records in the review
list.

3. There is no restriction for the sample records selected for the repeatability calculations
as long as they are the records in the review list.

(12) Export sample data

1. Click Export and a dialogue box will pop up as shown below;

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2. Click Checked Records or Specify Records radio button to select the records to be exported."Checked
Records " are records selected with "√" in the review list;
3. If Specify Records radio button is clicked, then the specified start and end proving data that are required to
be exported will be performed;
4. Click OK and a dialogue box will pop up as shown below;

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5. Select data export path, export file type and enter the export file name;
6. Click OK and a progress bar dialogue box will pop up;

7. Export has been completed. Click OK to quit.

Note:

1. The export file type is in .csv format by default and .txt format can also be selected.

2. The sequence of exported sample data records and each sample is consistent with the
ascending or descending order of the inspection time displayed in the list review
interface.

3. Exported data file does not support historical review for checking. Operators can edit
or delete the exported data file externally.

4. 3 histograms and 1 scattergram are exported as bmp format to "Bmp" folder under the
selected data export path.

5. You can choose whether to automatically remove the "√" marks in front of the
exported records.

(13) Back up sample data


1. Click Backup and a dialogue box will pop up as shown below;

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1. Click Checked Records or Specify Records to select the records that are required to be backed up."
Checked Records" are records selected with "√" in the review list;
2. If Checked Records radio button is clicked, then the specified start and end proving data that are required
to be exported will be performed;

Note:

1. It is not allowed to select backup file type.

2. It is not allowed to modify the backup sample data. It can only be checked as
historical review.

3. 3 histograms and 1 scattergram are backed up as bmp format to "Bmp" folder under
the selected data backup path.

4. You can choose whether to automatically remove the "√" marks in front of the
backed up records.

5. You can choose whether to automatically delete the records that have been backed
up.

(14) Historical Data Review


If you want to check the backup data, please follow the steps below:
1. Click Historical and a dialogue box will pop up as shown below;

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2. Select the file name of backup data you want to browse after selecting the directory of the backup data;
3. Click OK to display the selected backup data;
4. The data displayed in graph review and list review interfaces can only be browsed and checked.

7.3.2.2 Sample/Patient's Information


Click "Patient info." tab in the interface to check the sample and patient’s information corresponding to the
current highlighted record in the list.

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Please refer to the relevant contents of "Enter Work list Information" section in Chapter 6 Daily Operations
for the operations of the related information editing.

7.3.2.3 Microscopy and others


Click others tab in the interface to check and enter the microscopy, blood type and RSR rate information of
the sample.

 Parameter explanation

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Parameters Meanings Operations

Click Microscopy sample combo box and select Venous Blood


Microscopy Category of
or Peripheral Blood as the category of microscopy sample. The
sample microscopy sample
default category of microscopy sample is "Venous Blood".

Click the edit box of "Micro.Time" and enter date and time of
Micro.Time Microscopy time
microscopy

Describe cellular Directly enter the morphological information of each cell in the
Microscopy
morphologies of
description box
WBC, RBC and PLT.

Cell The percentages of each classified cell in the edit boxes can be
Cell classification
classification entered after the names of the 22 categorized cells respectively.
Select the patient's blood type in "B.Type" bar. Select "Blank",
"A", "B", "O" or “AB" in the first combo box after clicking
B.Type Patient's blood type
blood type, and select "Blank", "RH+" or "RH-" by clicking the
second combo box.

1. Click Set ref. Scope, and the following dialogue box will pop
up. Enter the lower limit and the upper limit of the reference
value of RSR rate in "Lower limit" and "Upper limit" edit
boxes;

If the measured value


of RSR rate has
exceeded the
reference value range,
ESR
it will be prompt with
"↑" or "↓", indicating
that the RSR rate
value is high/low.

2. Click OK to save the settings and refresh the interface


information.

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Note:

1. Microscopy time cannot be greater than the current system time.

2. The value range of cell classification entered is [0.0-100.0] and the unit is "%".

3. RSR rate information: The upper and lower limit range can be entered is [0, 999] and
only one to three digit number can be entered. The upper limit cannot be less than the
lower limit; The reference range of ESR results for each sample is only effective to that
result, and the default reference range is [0, 20].

7.3.2.4 Research
Click Research tab in the interface and then you can check the specific value of each parameter result.

Note:

1. Specific value for parameter results that have exceeded the display range or with no
collected data cannot be given.

2. Editing the results in "Data/Graph" tab will not affect the display of each parameter in
"Research" tab.

3. The contents in this tab are for research and checking only and cannot be edited,
printed or communicated.

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QC

Chapter 8. QC

8.1 Overview
A certain degree of error may occur when the haematology analyser has been used for a long period of time.
Errors may cause failure or unreliable analysis results. QC procedures provide an effective method for testing
errors that may exist. Operators can effectively eliminate the effects of errors to the analysis results only
when they are familiar with the theory of QC and have mastered the actual operation methods.
To ensure the reliability of the sample analysis results, operators are recommended to use controls of low,
normal and high levels respectively to perform QC on the analyser every day. When the controls with new lot
number are required, please use them with the current controls in parallel twice daily for 5 days. The results
obtained should be within the reference range specified in its operating manual.
The analyser provides four methods of QC: L-J QC, X QC, X -R QC and X-B floating average mean
method QC.

Note:

Operators should use the controls and reagents designated by our company, and store
and use them in strict accordance with the operation manual. Controls (similar with
standard blood samples) must be used before the expiry date and thoroughly mixed
before use.

8.2 L-J QC

8.2.1 QC edit

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

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Note:

1. Only the users at an administrator level have the privilege to perform QC edit.
2. For the QC files containing QC results, the modified data will be highlighted with
yellow background and recorded in the system log if the parameter reference values
or deviation limits have been modified and saved that will lead to the changes in
reference values and deviation limits.

A QC file for each lot number of controls needs to be set before analysing a new batch of controls and the QC
information in the file can be edited through any one of the following methods.
Manual entry.
Read saved preset value.
8.2.1.1 Manual entry
(1) Enter the QC chart interface by any one of the following methods:
1. Click QC on the shortcut button area.
2. Click Menu on the interface, and select QC  L-J QC in the pop-up menu.

3. Enter the L-J QC chart interface.

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(2) Click Settings tab to enter the L-J QC setting interface.

Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

(3) Select a QC file number of which the QC information is empty.

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Note:

The selecting range of file numbers is 1-60.

(4) Input the lot number of the controls by any one of the following methods.
1. Input manually
2. Input by using an external barcode scanner (not supported temporarily)

Note:

1. The lot number cannot be null. The input range is 1-16 characters. Characters,
numbers, letters and special characters are allowed except Chinese.

2. The lot number and QC mode of the QC file cannot be the same simultaneously.

(5). Input the batch expiry date of the controls.

Note:

The input range of expiry date is [the current system date, 2099-12-31]. It cannot be
null.

(6). Select the QC mode for analysing controls.

Note:

The lot number and QC mode of the QC file cannot be the same simultaneously.

(7). Select the level of controls.


(8). Input the reference value and deviation limit separately in the edit boxes after the parameters to which
you want to perform QC. This is all in accordance with the target value table of corresponding lot numbers.
(9). Click Save to save the input QC information.

8.2.1.2 Read saved preset value

Note:

If the preset value of the current level is stored in the system (reference values and
deviation limits), it can be read to the current QC file. Please refer to 8.2.3 QC
Results Review for the calculating and saving methods of preset values.

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(1) Basic operations
1. Enter the QC chart interface by any one of the following methods:
a. Click QC in the shortcut button area;
b. Click Menu on the interface and select QC  L-J QC in the pop-up menu;

c. Enter the L-J QC chart interface.

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2. Click Settings to enter the L-J QC setting interface.

Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

3. Select a QC file number of which the QC information is empty.

Note:

The selecting range of file numbers is 1-60.

4. Input the lot number of the controls by any one of the following methods.
a. Input manually;
b. Input by using an external barcode scanner (not supported temporarily).

Note:

1. The lot number cannot be null. The input range is 1-16 characters. Characters,
numbers, letters and special characters are allowed except Chinese.

2. The lot number and QC mode of the QC file cannot be the same
simultaneously.

5. Input the expiry date of the controls’ lot;

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Note:

The input range of expiry date is [the current system date, 2099-12-31]. It cannot
be null.

6. Select the QC mode for analysing controls;

Note:

The lot number and QC mode of the QC file cannot be the same simultaneously.

7. Select the level of controls;


8. Click Get Preset Value to read the parameter reference value and deviation limit that corresponds to the
current level of the current QC file;

Note:

If preset values of some parameters to undergo QC are not provided, you will
need to input their reference values and deviation limits manually; If you don't
want to perform QC on some parameters that are provided with preset values, you
can delete their reference values and deviation limits manually after obtaining the
preset values.

9. Click Save to save the input QC information.


8.2.1.3 Deviation limit setting
If you want to adjust the display form of deviation limits or the calculating method of deviation limits in
preset value, you can follow the steps below:
(1) Click Set Deviation Limit and the following dialogue box will pop up;

8-7
(2) Click Calculate by Absolute Value to display the deviation limit in the form of an absolute value; Click
Calculate by Percentage to display the deviation limit in the form of a percentage;
(3) If you choose to calculate by absolute value, click 2SD or 3SD, then the deviation limit will be calculated
according to 2 or 3 times of the SD; If you choose to calculate by percentage, click 2CV or 3CV, then the
deviation limit will be calculated according to 2 or 3 times of the CV;
(4) Click OK to save settings of deviation limits.

8.2.1.4 Print
Click Print to print the setting information of the current QC file.

8.2.2 QC analysis
You can select one of the following methods to perform QC analysis according to the QC mode selected after
editing the QC:
Whole blood
Predilution
8.2.2.1 QC analysis (whole blood)

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)

8-8
when touching relevant items and regions in the laboratory.

Warnings:

1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase
the risks of biological problems. Please be careful when operating the uncovered
blood collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood
collection tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to prevent injuries.

5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical
mask, etc.) when touching reagent-related items in the library.

6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty
of water and seek medical treatment from a doctor.

Note:

Do not use disposable items repeatedly.

Note:

1. The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.
2. If the blood mode switches from "predilution" to "whole blood", the analyser
will execute mode switching fluidics sequence automatically and display the
progress bar prompt on the interface.

(1) Enter the QC chart interface by any one of the following methods:

1. Click QC in the shortcut button area;


2. Click Menu in the interface and select QC  L-J QC in the pop-up menu;

8-9
3. Enter the L-J QC chart interface.

(2) Click Counting tab to enter the L-J QC counting interface;

8-10
Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions.
(7) Perform QC analysis:
1. Confirm that the QC mode is "whole blood" and the counting status icon and state light of the analyser are
green;
2. Shake the prepared controls as shown in the following figure to thoroughly mix it;

8-11
3. Click Start QC Counting;

4. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
5. Press the counting button to initiate the QC analysis;
6. The buzzer rings when the absorption is completed. The user can remove the controls.
(8) After the analysis, the QC results obtained will be displayed on the current interface and will be
automatically saved in the current QC files;

Note:

Each QC file can store 300 QC results at most.

(9) You may continue to perform QC analysis according to the steps above if necessary.

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QC

8.2.2.2 QC analysis (Predilution)

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.

Warnings:

1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase
the risks of biological problems. Please be careful when operating the uncovered
blood collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood
collection tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to keep them from injury.

5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical
mask, etc.) when touching reagent-related items in the library.

6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty
of water and seek medical treatment from a doctor.

Note:

Do not use disposable items repeatedly.

Note:

The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.

8-13
(1) Enter the QC chart interface by any one of the following methods:

1. Click QC in the shortcut button area;


2. Click Menu in the interface and select QC  L-J QC in the pop-up menu;

3. Enter the L-J QC chart interface.

8-14
(2) Click Counting tab to enter the L-J QC counting interface;

Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:
1. Confirm that the QC mode is "predilution" and the counting status icon and state light of the analyser are
green;
2. Click Add Diluent in the shortcut button area and the following prompt box will pop up;

3. When the preparation is completed, the following dialogue box will pop up;

8-15
4. Take a clean centrifuge tube. Insert the probe vertically into the bottom of the centrifuge tube after opening
the cover as shown in the following figure to avoid producing bubbles, suspending liquid or spilling while
adding diluent;

5. Press the counting button to start adding diluent;

6. The buzzer rings when the addition of diluent is completed. The user then can remove the centrifuge tube;
7. Collect 20μL of the controls and inject it into a centrifuge tube with diluent inside. Then fix the cover on
and thoroughly mix it;

8-16
8. Click Cancel to exit the diluent addition dialogue box;

9. When the cleaning is completed, close the prompt;


10. Click Start QC Counting;

11. Put the centrifuge tube under the probe after opening the cover to allow the needle to suck up the fully
mixed controls;
12. Press the counting button to initiate the QC analysis;
13. The buzzer rings after the absorption process is completed. The user can remove the centrifuge tube.

(8) After the analysis, the QC results obtained will be displayed on the current interface and will be
automatically saved in the current QC files;

Note:

1. Operators can also absorb 180μL diluent with a transferpettor.

2. Prevent dust from entering the prepared diluent, otherwise analysis errors may

8-17
arise.

3. After controls are fully reacted with the diluent, it needs to be laid for 3 minutes,
and then mixed again before analysis.

4. Make sure to perform the analysis within 30 minutes after the sample is diluted,
otherwise the analysis results will be unreliable.

5. Samples that have been laid for a period of time need to be mixed again before
analysis.

6. Every laboratory should evaluate the stability of QC analysis results at the


predilution mode based on the respective number of samples, sample collecting
methods and technical levels.

7. Each QC file can store 300 QC results at most.

(9) You may continue to perform QC analysis according to the steps above if necessary.

8.2.2.3 Browsing results


If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or to switch the current QC result to the previous one or the next one of the current

result. Click or to switch the current QC result to the earliest saved result or the newest

saved result in the QC file.

Note:

1. Expired QC analysis results will be marked with the letter "O" before it.

2. The results out of the set deviation limit range are marked with "↑" or "↓" for
prompting;

3. For the QC files that store QC results, if the upper and lower limit ranges of
some parameters are changed when the reference values or deviation limits of these
parameters are modified and saved, the changed data will be highlighted in yellow.

8.2.3 QC result review


When the QC analysis is completed, the user can review the QC results in the following two ways:
QC chart
 QC List

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8.2.3.1 QC chart review

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

(1) Enter the QC chart interface by any one of the following methods:
1. Click QC in the shortcut button area;
2. Click Menu in the interface and select QC  L-J QC in the pop-up menu;

3. Enter the L-J QC chart interface.

8-19
(2) Select the file number of the QC file you want to review, and the interface will display corresponding file
information and QC chart;
(3) Drag the scroll bar on the right of the QC chart up and down to review the param QC chart that you want
to review. Drag the scroll bar below the QC chart left and right to review all the QC results.

8.2.3.1.1 Introduction to QC chart interface

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1 - Average values (Mean), standard deviations (SD) and coefficients of variation (CV%) of all the QC results
of all the parameters in the current QC chart;
2 - The saved date and time of the QC point at which the green vertical line lies;
3 - The operator that performs QC analysis and obtains the QC point at which the green vertical line lies;
4 - The parameter QC results corresponding to the QC point at which the green vertical line lies;
5 - The QC points in each parameter QC chart are arranged from left to right and from old to new. All the QC
points are linked with lines, which makes it easy to view the distribution trend;
6 - The QC point corresponding to each QC result. Only the values of the selected QC points can be
displayed under the parameter. If the QC point is black, it means its value is within the upper and lower limits;
If the QC point is red, it means its value is out of the upper and lower limit range;
7 - When clicking a QC point in the QC chart, mark this point and the QC points of the parameters that are
saved at the same time with green vertical lines;
8 - Relative positions of the QC point at which the green vertical line lies among all the QC points as well as
the number of QC points that are currently saved.

Note:

1. Results that are out of control won't be included in the calculation of Mean, SD
and CV%.

2. For the QC files that store QC results, if the upper and lower limit ranges of
some parameters are changed when the reference values or deviation limits of
these parameters are modified and saved, the changed data will be highlighted in
yellow.

8.2.3.1.2 Browsing results

If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or to move the green vertical line to the previous or next QC point; Click or

to move the green vertical line to the first or the last QC point of the QC chart. When the location of

the green vertical line is fixed, the area below each QC parameter name will display the QC result of the QC
point at which the green vertical line lies.

8.2.3.1.3 New bottle

If the reviewed QC result is obtained from analysing the controls that are newly opened within the same
batch, the QC points of new bottles should be marked based on the following steps to differentiate the QC
analysis results of the controls in old bottles and new bottles:
(1) Move the green vertical line to the QC point of the first new bottle;

8-21
(2) Click New Bottle, and there will be a blue vertical line at the QC point of the new bottle;

(3) Open the controls within the same new bottle batch again and save its QC analysis results. Then click
Cancel New Bottle and cancel the original mark. And then mark the QC point of the new bottle according to
Step 1 and Step 2.

8.2.3.1.4 Data comparison

If you want to compare the QC charts of the same parameter in different batches of controls, please follow
the steps below:
(1) Click Data Comparison, and the selection of QC chart is provided;

(2) Select the files numbers of QC files that you want to compare in the File Number box in turn (3 file
numbers at most). The corresponding QC chart of the selected file number is displayed below the file number,
and its batch, QC mode and level are also displayed;
(3) You can select the QC charts of different parameters in the Parameter box to compare as required.

Note:

The display form and view method of the QC chart are in accordance with the QC
chart interface. The lines connecting QC points are grey, black and orange so as to
differentiate the QC charts of different levels of controls.

(4) If you want to print the currently compared parameter QC chart, please click Print (not supported
temporarily);
(5) Click Close to exit.

8-22
8.2.3.1.5 Display sequence

If you want to change the display sequence of different parameter QC charts, please follow the steps below:
(1) Click Display Sequence, and the display sequence of the current QC charts will be provided;

(2) Click the parameter that is desired to adjust the display order of the QC chart;

(3) Click or to move this parameter forward or backward; Click or

to move this parameter to the beginning or end;


(4) Click OK and the display sequence of QC chart will be refreshed.

8.2.3.1.6 Save preset value

If the already existing QC parameter has three or more QC results within the upper and lower limit range,
then the preset values of QC parameters can be calculated and saved by following these steps.
(1) Click Calculate Preset Value to display two selection lines within the preset value calculation range.

(2) Click and drag each selection line separately to position at the start point and end point of the preset value
calculation range.

(3) The values of Mean, SD, and CV% on the right of the QC chart are refreshed as the calculation results of
the selected range.

(4) If you want to save the calculation result, please click Save Preset Value to save the existing calculation
results of Mean, SD and CV% as the preset values of the corresponding levels (high/normal/low). Then, the

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selection lines will disappear and Mean, SD, and CV% on the right of the QC chart will restore to the
calculation values of all the QC results.

Note:

1. The preset values will be calculated and displayed for the parameters that have 3
or more results within their calculation ranges and upper and lower limit ranges;
Otherwise, the preset values are empty.

2. Three saving functions are provided according to the levels (high, normal, and
low) of controls.

3. The results of all the parameters must be within its upper and lower limit range
when calculating the preset values.

8.2.3.1.7 Entering the reason for loss of control

If you want to enter why the QC point is out of control, please follow the steps below:

(1) Click Out of Control after moving the green vertical line to the QC point desired to enter the reason for
loss of control. It will display the QC results, reference values and deviation limits of all parameters where
the green vertical lines lie (QC results that exceed the range of upper and lower limits will be marked in red)
and provide the function of entering the reason for loss of control;

(2) The reason for loss of control can be selected from a list of provided reasons. Or one can manually enter
the reason for Loss of Control (200 characters max.) in the edit box after clicking the Others option;

(3) Click OK to save the entered reason for loss of control and exit.

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Note:

After entering the reason for loss of control for a set of QC points of which the
QC results of parameters are within the deviation limits, the whole set of QC data
will be all marked in red that correspond to this set of QC points in QC chart/QC
list. If the reason for loss of control is cancelled and saved, the corresponding
whole set of QC data will be recovered and shown as black again.

8.2.3.1.8 Delete

With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, please move the green vertical line to the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;

(3) Click the data you want to delete;

(4) Click OK and confirm. All the selected data will be deleted.

Note:

The deletion event will be recorded in the log.

8.2.3.2 QC list review

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.

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(1) Enter the QC list interface by any one of the following methods:

1. Click QC in the shortcut button area;


2. Click Menu in the interface and select QC  L-J QC in the pop-up menu;

3. Enter the L-J QC chart interface.

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(2) Click the QC List tab and enter the L-J QC list interface;

(3) Select the file number of the QC files you want to review, and the interface will display corresponding file
information and QC list;
(4) Drag the scroll bar on the right of the QC list up and down to review the parameter QC result you want to
review. Drag the scroll bar below the QC list left and right to review all the QC results.

8.2.3.2.1 Introduction to the QC list interface

1 - Serial number of QC results saved in QC files (arranged from left to right and from old to new);

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2 - QC results;
3 - QC parameter (the display order is in accordance with the QC chart interface);
4 - QC warning signs: The results out of the set deviation limit range are marked with "↑" or "↓" for
prompting;
5 - The relative location of highlighted QC results among all the QC results and the number of QC results
saved currently.

Note:

For the QC files that store QC results, if the reference values or deviation limits of
some parameters are changed when the reference values or deviation limits of these
parameters are modified and saved, the changed data will be highlighted in yellow.

8.2.3.2.2 Browsing results

If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or , and the previous or the next QC result will be highlighted; Click or ,

and the first or the last QC result will be highlighted in the QC list.

8.2.3.2.3 Delete

With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, then click the column which contains the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;

(2) Click Delete to select whether to delete the current data or all data;

(3) Click the data you want to delete;

(4) Click OK and confirm. All the selected data will be deleted.

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Note:

The deletion event will be recorded in the log.

8.2.3.2.4 Data export

If you want to export the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data export to provide the function of entering the file names of the exported path and related data;

(2) Select the exported path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the exported data (default to: [L-J_QC_Data saved date_time]);

(4) Select the file type of the exported data.(Default to .CSV);

(5) Click OK and start exporting;

(6) The interface prompts that the exporting is finished. Click OK to exit.

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Note:

You can modify the exported data if necessary, but you cannot check it through
Historical Review function.

8.2.3.2.5 Data backup

If you want to backup the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Backup, and the function of entering the file names of backup path and data is provided;

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(2) Select a backup path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);

(3) Enter the file name of the backup data (default to: [L-J_QC_Data saved date_time]);

(4) Click OK and start backup;

(5) The interface prompts that the backup is completed. Click OK to exit.

Note:

1. The backup data cannot be modified. You can check it through Historical Review
function.

2. You can click Cancel on the progress bar to cancel the backup during the backup.

3. Please back up the data periodically.

8.2.3.2.6 Historical review

If you want to check the backup data, please follow the steps below:
(1) Click Historical Review and a dialogue box shown below will pop up;

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(2) Select the file name of the backup data you want to browse after selecting the directory where the backup
data exists;
(3) Click OK to display the selected backup data;

(4) The display forms of file information and result list as well as the button function are the same as the QC
list interface. If you want to view and print (not supported temporarily) the results in the list or export data,
you can refer to the operation methods in the QC list interface;

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(5) Click Close to exit after reviewing.

8.3 X Mean QC

8.3.1 QC edit

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

Note:

1. Only the users at an administrator level have the privilege to perform QC edit.
2. For the QC files containing QC results, the modified data will be highlighted
with yellow background and recorded in the system log if the parameter reference
values or deviation limits have been modified and saved that will lead to the
changes in reference values and deviation limits.

A QC file for each lot number of controls needs to be set before analysing a new batch of controls and the QC
information in the file can be edited through any one of the following methods.
 Manual entry.
 Read saved preset value.
8.3.1.1 Manual entry
(1) Enter the QC chart interface by the following methods:
1. Click Menu on the interface, and select QC X Mean QC in the pop-up menu;

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2. Enter X Mean QC chart interface.

(2) Click the Settings tab to enter X Mean QC setting interface.

Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

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(3) Select a QC file number of which the QC information is empty;

Note:

The selecting range of file numbers is 1-60.

(4) Input the lot number of the controls in one of the following ways;
1. Input manually
2. Input by using an external barcode scanner (not supported temporarily)

Note:

1. The lot number cannot be null. The input range is 1-16 characters. Characters,
numbers, letters and special characters are allowed except Chinese.

2. The lot number and QC mode of the QC file cannot be the same
simultaneously.

(5) Input the batch expiry date of the controls;

Note:

The input range of expiry date is [the current system date, 2099-12-31]. It cannot
be null.

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(6) Select the QC mode for analysing the controls;

Note:

The lot number and QC mode of the QC file cannot be the same simultaneously.

(7) Select the level of controls;


(8) Input the reference value and deviation limit separately in the edit boxes for parameters to which you
want to perform QC. This is in accordance to the target value table of corresponding lot numbers.
(9) Click Save to save the input QC information.

8.3.1.2 Deviation limit setting


If you want to adjust the display form of deviation limits or the calculating method of deviation limits in
preset value, you can follow the steps below:
(1) Click Set Deviation Limit and the following dialogue box will pop up;

(2) Click Calculate by Absolute Value to display the deviation limit in the form of an absolute value; Click
Calculate by Percentage to display the deviation limit in the form of a percentage;
(3) If you choose to calculate by absolute value, click 2SD or 3SD, then the deviation limit will be calculated
according to 2 or 3 times of the SD; If you choose to calculate by percentage, click 2CV or 3CV, then the
deviation limit will be calculated according to 2 or 3 times of the CV;
(4) Click OK to save settings of deviation limits.

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8.3.2 QC analysis
You can select one of the following methods to perform QC analysis according to the QC mode selected after
editing the QC:
 Whole blood
 Predilution

8.3.2.1 QC analysis (whole blood)

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.

Warnings:

1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase
the risks of biological problems. Please be careful when operating the uncovered
blood collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood
collection tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to prevent injuries.

5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical
mask, etc.) when touching reagent-related items in the library.

6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty
of water and seek medical treatment from a doctor.

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Cautions:

Do not use disposable items repeatedly.

Note:

1. The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.
2. If the blood mode switches from "predilution" to "whole blood", the analyser
will execute mode switching fluidics sequence automatically and display the
progress bar prompt on the interface.

(1) Enter the QC Chart interface by the following methods:


Click Menu on the interface, and select QC  X Mean QC in the pop-up menu.

Enter X Mean QC Chart interface.

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(2) Click Counting tab to enter X Mean QC counting interface.

Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:

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1. Confirm that the QC mode is "whole blood" and the counting status icon and state light of the analyser are
green;
2. Shake the prepared controls as shown in the following figure to fully mix it;

3. Click Start QC Counting;

4. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
5. Press the counting button to initiate the QC analysis;

6. The buzzer rings when the absorption process is completed. The user can then remove the controls;
7. When the analysis is finished, the interface will display the QC results of the first analysis;

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8. When the controls are mixed again, please perform the second QC analysis according to the prompts on the
interface;

Note:

You can cancel the second QC analysis by clicking Cancel in the dialogue box.
And the first QC analysis results won't be saved.

9. The buzzer rings when the absorption process is completed. The user can then remove the controls.
(8) When the analysis is completed, the QC results obtained (two times of the QC counting values and

average values X ) will be displayed on the current interface and will be automatically saved in the current

QC files;

Note:

1. When the second QC analysis results are obtained, the histogram and
scattergram displayed on the interface will be refreshed as the corresponding
figures of the second QC analysis results.

2. Each QC file can store 300 QC results (average values X ) at most.

(9) You may continue to perform QC analysis according to the steps above if necessary.

8.3.2.2 QC analysis (predilution)

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal

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protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

Warnings:

1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase the
risks of biological problems. Please be careful when operating the uncovered blood
collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood collection
tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to prevent injuries.

5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical mask,
etc.) when touching reagent-related items in the library.

6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty of
water and seek medical treatment from a doctor.

Note:

Do not use disposable items repeatedly.

Note:

The operator must use disposable items specified by the company, such as vacuum
blood collection tubes, centrifuge tubes, capillaries, etc.

(1) Enter the QC Chart interface by the following methods:


1. Click Menu on the interface, and select QC  X Mean QC in the pop-up menu.

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2. Enter X Mean QC Chart interface.

(2) Click Counting tab to enter X Mean QC counting interface.

Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

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(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:
1. Confirm that the QC mode is "predilution" and the counting status icon and state light of the analyser are
green;
2. Click Add Diluent in the shortcut button area and the following prompt box will pop up;

3. When the preparation is completed, the following dialogue box will pop up;

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4. Take a clean centrifuge tube. Insert the probe vertically into the bottom of the centrifuge tube after opening
the cover as shown in the following figure to avoid producing bubbles, suspending liquid or spilling while
adding diluent;

5. Press the counting button and start to add diluent;

6. The buzzer rings when the addition of diluent is completed. The user then can remove the centrifuge tube;
7. Collect 20μL of the controls and inject it into a centrifuge tube with diluent inside. Then fix the cover on
and thoroughly mix it;

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8. Click Cancel to exit the diluent addition dialogue box;

9. When the cleaning is completed, close the prompt;


10. Click Begin QC Counting;

11. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
12. Press the counting button to initiate the QC analysis;

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13. The buzzer rings when the absorption is completed. The user can then remove the controls;
14. When the analysis is finished, the interface will display the QC results of the first analysis;

15. When the controls are mixed again, please perform the second QC analysis according to the prompts on
the interface;

Note:

You can cancel the second QC analysis by clicking Cancel in the dialogue box.
And the first QC analysis results won't be saved.

16. The buzzer rings when the absorption process is completed. The user can then remove the centrifuge tube.
(8) When the analysis is completed, the QC results obtained (two times of the QC counting values and

average values X ) will be displayed on the current interface and will be automatically saved in the current

QC files;

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Note:

1. Operators can also absorb 180μL diluent with a pipette.

2. Prevent dust from entering the prepared diluent, otherwise analysis errors may
arise.

3. After controls are fully reacted with the diluent, it needs to be laid for 3
minutes, and then mixed again before analysis.

4. Make sure to perform the analysis within 30 minutes after the sample is
diluted, otherwise the analysis results will be unreliable.

5. Samples that have been laid for a period of time need to be mixed again before
analysis.

6. Every laboratory should evaluate the stability of QC analysis results at the


predilution mode based on the respective number of samples, sample collecting
methods and technical levels.

7. Each QC file can store 300 QC results at most.

8. When the second QC analysis results are obtained, the histogram and
scattergram displayed on the interface will be refreshed as the corresponding
figures of the second QC analysis results.

9. Each QC file can store 300 QC results (average values X ) at most.

(9) You may continue to perform QC analysis according to the steps above if necessary.

8.3.2.3 Browsing results


If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or to switch the current QC result to the previous one or the next one of the current

result. Click or to switch the current QC result to the earliest saved result or the newest saved

result in the QC file.

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Note:

1. Expired QC analysis results will be marked with the letter "O" before it.

2. If the average values X of two QC analysis results fall outside of the


deviation limits, warning prompts of "↑" and "↓" will appear before the average
values X .

3. For the QC files that store QC results, if the upper and lower limit ranges of
some parameters are changed when the reference values or deviation limits of
these parameters are modified and saved, the changed data will be highlighted in
yellow.

8.3.2.4 Print
Click Print and print the result on the current QC counting interface.

8.3.3 QC result review


When the QC analysis is completed, the user can review the QC results in the following two ways:
 QC chart
 QC list

8.3.3.1 QC chart review

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

(1) Enter the QC Chart interface by the following methods:


1. Click Menu on the interface, and select QC  X Mean QC in the pop-up menu;

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2. Enter X Mean QC Chart interface.

(2) Select the file number of the QC file you want to review, and the interface will display corresponding file
information and QC chart;
(3) Drag the scroll bar on the right of the QC chart up and down to review the parameter QC chart that you
want to review. Drag the scroll bar below the QC chart left and right to review all the QC results.

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8.3.3.1.1 Introduction to QC Chart interface

1 - Average values (Mean), standard deviations (SD) and coefficients of variation (CV%) of all the QC results
of all the parameters in the current QC chart;
2 - The saved date and time of the QC point at which the green vertical line lies;
3 - The operator that performs QC analysis and obtains the QC point at which the green vertical line lies;
4 - The parameter QC results corresponding to the QC point at which the green vertical line lies;
5 - The QC points in each parameter QC chart are arranged from left to right and from old to new. All the QC
points are linked with lines, which makes it easy to view the distribution trend;
6 - The QC point corresponding to each QC result. Only the values of the selected QC points can be
displayed under the parameter. If the QC point is black, it means its value is within the upper and lower limits;
If the QC point is red, it means its value is out of the upper and lower limit range;
7 - When clicking a QC point in the QC chart, mark this point and the QC points of the parameters that are
saved at the same time with green vertical lines;
8 - Relative positions of the QC point at which the green vertical line lies among all the QC points as well as
the number of QC points that are currently saved.

Note:

1. The value of the QC points represent the average values X of the QC


analysis results for each group.

2. Results that are out of control won't be included in the calculation of Mean, SD
and CV%.

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3. For the QC files that store QC results, if the reference values and upper and
lower limit ranges of some parameters are changed when the reference values or
deviation limits of these parameters are modified and saved, the changed data will
be highlighted in yellow.

8.3.3.1.2 Browsing results

If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or to move the green vertical line to the previous or next QC point; Click or

to move the green vertical line to the first or the last QC point of the QC chart. When the location of

the green vertical line is fixed, the area below each QC parameter name will display the QC result of the QC
point at which the green vertical line lies.

8.3.3.1.3 New bottle

If the reviewed QC result is obtained from analysing the controls that are newly opened within the same
batch, the QC points of new bottles should be marked based on the following steps to differentiate the QC
analysis results of the controls in old bottles and new bottles:
(1) Move the green vertical line to the QC point of the first new bottle;
(2) Click New Bottle, and there will be a blue vertical line at the QC point of the new bottle;
(3) Open the controls within the same new bottle batch again and save its QC analysis results. Then click
Cancel New Bottle and cancel the original mark. And then mark the QC point of the new bottle according to
Step 1 and Step 2;
(4) If you want to print the currently compared parameter QC chart, please click Print;
(5) Click Close to exit.

8.3.3.1.4 Display sequence

If you want to change the display sequence of different parameter QC charts, please follow the steps below:
(1) Click Display Sequence, and the display sequence of the current QC charts will be provided;

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(2) Click the parameter that is desired to adjust the display order of the QC chart;

(3) Click or to move this parameter forward or backward; Click or

to move this parameter to the beginning or end;


(4) Click OK and the display sequence of QC chart will be refreshed.

8.3.3.1.5 Entering the reason for loss of control

If you want to enter why the QC point is out of control, please follow the steps below:
(1) Click Out of Control after moving the green vertical line to the QC point desired to enter the reason for
loss of control. It will display the QC results, reference values and deviation limits of all parameters where
the green vertical lines lie (QC results that exceed the range of upper and lower limits will be marked in red)
and provide the function of entering the reason for loss of control;

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(2) The reason for loss of control can be selected from a list of provided reasons. Or one can manually enter
the reason for Loss of Control (200 characters max.) in the edit box after clicking the Others option;
(3) Click OK to save the entered reason for loss of control and exit.

Note:

After entering the reason for loss of control for a set of QC points of which the QC
results of parameters are within the deviation limits, the whole set of QC data will
be all marked in red that correspond to this set of QC points in QC chart/QC list. If
the reason for loss of control is cancelled and saved, the corresponding whole set of
QC data will be recovered and shown as black again.

8.3.3.1.6 Delete

With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, please move the green vertical line to the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;

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(3) Click the data you want to delete;
(4) Click OK and confirm. All the selected data will be deleted.

Note:

The deletion event will be recorded in the log.

8.3.3.2 QC list review

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

(1) Enter the QC list interface by any one of the following methods:
1. Click QC in the shortcut button area;
2. Click Menu on the interface, and select QC  X Mean QC in the pop-up menu;

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3. Enter X Mean QC Chart interface.

(2) Click QC tab to enter X Mean QC List interface;

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(3) Select the file number of the QC files you want to review, and the interface will display corresponding file
information and QC list;
(4) Drag the scroll bar on the right of the QC list up and down to review the parameter QC result you want to
review. Drag the scroll bar below the QC list left and right to review all the QC results.

8.3.3.2.1 Introduction to the QC list interface

1 - Serial number of QC results saved in QC files (arranged from left to right and from old to new);
2 - QC results;
3 - QC parameter (the display order is in accordance with the QC chart interface);
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4 - QC warning signs:The results (average value X ) out of the set deviation limit range are marked with "↑"
or "↓" for prompting;
5 - The relative location of highlighted QC results among all the QC results and the number of QC results
saved currently.

Note:

1. The value of the QC points represent the average values X of the QC analysis
results for each group.

2. For the QC files that store QC results, if the upper and lower limit ranges of some
parameters are changed when the reference values or deviation limits of these
parameters are modified and saved, the changed data will be highlighted in yellow.

8.3.3.2.2 Browsing results

If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or , and the previous or the next QC result will be highlighted; Click or ,

and the first or the last QC result will be highlighted in the QC list.

8.3.3.2.3 Delete

With the administrator privilege, you may delete the QC results by following these steps:
(1) If you want to delete a single QC result, then click the column which contains the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;

(3) Click the data you want to delete;


(4) Click OK and confirm. All the selected data will be deleted.

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Note:

The deletion event will be recorded in the log.

8.3.3.2.4 Data export

If you want to export the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Export to provide the function of entering the file names of the exported path and related
data;

(2) Select the exported path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the exported data (default to: [Xaverage value_QC_Data saved date_time]);
(4) Select the file type of the exported data.(Default to .CSV);
(5) Click OK and start exporting;

(6) The interface prompts will prompt when the exporting has completed. Click OK to exit;

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Note:

You can modify the exported data if necessary, but you cannot check it through
Historical Review function.

8.3.3.2.5 Data backup

If you want to backup the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Backup, and the function of entering the file names of backup path and data is provided;

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(2) Select a backup path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the backup data (default to: [Xaverage value_QC_Data saved date_time]);
(4) Click OK and start backup;

(5) The interface prompts that the backup is completed. Click OK to exit.

Note:

1. The backup data cannot be modified. You can check it through Historical Review
function.

2. You can click Cancel on the progress bar to cancel the backup during the backup.

3. Please back up the data periodically.

8.3.3.2.6 Historical review

If you want to check the backup data, please follow the steps below:
(1) Click Historical Review and a dialogue box shown below will pop up;

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(2) Select the file name of the backup data you want to browse after selecting the directory where the backup
data exists;
(3) Click OK to display the selected backup data;

(4) The display forms of file information and result list as well as the button function are the same as the QC
list interface. If you want to view and print (not supported temporarily) the results in the list or export data,
you can refer to the operation methods in the QC list interface;
(5) Click Close to exit after reviewing.

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8.4 X-B QC

8.4.1 QC principle
X-B floating average method, a method of monitoring the performance of the analyser by monitoring the
stability of RBC parameters of MCV, MCH, MCHC, etc. It belongs to the QC method without control.
Controls and it both belong to the means of performance monitoring of the analyser. They can respectively
reflect the analysis capability of the analyser from different sides but cannot replace each other.
When the daily sample size is greater than 100, and X-B QC is recommended for use. This QC method does
not apply to samples classified under the disease category because of random sampling. It has a reference
range composed of the given reference value and upper and lower limits and observes the change trend of QC
results within the reference range.
This analyser performs X-B QC for the following three parameters of MCV, MCH, MCHC. The sample size
of each group performing X-B numerical value analysis can be set to 20 - 200. The sample comes from the
normal counting results of the analyser. It does not distinguish between whole blood mode and predilution
mode. The analyser can save 500 X-B QC results at most. When the saved QC results exceed the maximum
number, the new QC result will replace the earliest result.

8.4.2 QC edit

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that come
into contact with these items have the potential of biological infection. Operators should
observe laboratory safety operation rules and wear personal protective devices (such as
laboratory protective clothing, gloves, mask, etc.) when touching relevant items and
regions in the laboratory.

Note:

Only the user of administrator level has the privilege to perform QC editing.

The editing of QC information should be completed by any of the following ways before QC analysis.
 Manual entry;
Read saved preset value.

8.4.2.1 Manual entry


(1) Enter the QC Chart interface by the following methods:
1. Click Menu on the interface and select QC  X-B QC in the pop-up menu;

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2. Enter the X-B QC chart interface.

(2) Click Settings tab to enter the X-B QC setting interface;

Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

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(3) Enter the selected number of sample results when counting one X-B QC points in the "Number of
Samples/Group" edit box. The selecting range is 20 - 200 and 20 is recommended.
(4) Click Open of X-B QC to open X-B QC. Take the effective result that the later sample counting obtained
as the required sample result of X-B QC analysis;
(5) Enter the reference value and deviation limits of the QC parameter;

Note:

1. The reference values and deviation limits of all QC parameters must be


entered and cannot be null.

2. Initial values of the reference values and deviation limits of the three QC
parameters will be provided by default in the beginning.

3. Users are not allowed to modify the reference value or deviation limit if QC
data has already existed in QC file.

(6) Click Save to save the entered QC information.

8.4.2.2 Deviation limit setting


If you want to adjust the display form of deviation limits or the calculating method of deviation limits in
preset value, you can follow the steps below:
(1) Click Set Deviation Limit and the following dialogue box will pop up;

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(2) Click Calculate by Absolute Value to display the deviation limit in the form of an absolute value; Click
Calculate by Percentage to display the deviation limit in the form of a percentage;
(3) If you choose to calculate by absolute value, click 2SD or 3SD, then the deviation limit will be calculated
according to 2 or 3 times of the SD; If you choose to calculate by percentage, click 2CV or 3CV, then the
deviation limit will be calculated according to 2 or 3 times of the CV;
(4) Click OK to save settings of deviation limits.

8.4.2.3 Default value reset


If you want to reset the reference value and deviation limits of the parameter to default initial value when
performing a QC edit, please click Default Value Reset to read in the default initial value system saved to the
X-B QC file.
Default initial values of each parameter reference values are:
MCV: 89.5fL

MCH: 30.5pg

MCHC: 340g/L

Default initial values of each parameter deviation limits are:


MCV: 2.7 fL

MCH: 0.9 pg

MCHC: 10 g/L

Note:

Default value reset is not allowed if QC data already exists in the QC file.

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8.4.3 QC analysis

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.

The system will automatically execute the operation of X-B QC counting after QC editing is completed.
The system will automatically execute the operation of X-B QC calculation one time every 20 - 200(based on
settings) effective sample results. The obtained QC results can be reviewed in the X-B QC chart or X-B QC
list.

8.4.4 QC result review


When the QC analysis is completed, the user can review the QC results in the following two ways:
 QC chart
 QC list

8.4.4.1 QC chart review

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

(1) Enter the QC Chart interface by the following methods:


1. Click Menu on the interface and select QC  X-B QC in the pop-up menu;

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2. Enter the X-B QC chart interface.

(2) Drag the scroll bar below the QC chart left and right to review all the QC results.

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8.4.4.1.1 Introduction to QC chart interface

1 - Average value (Mean), standard deviations (SD) and coefficients of variation of all the QC results of all
the parameters in the current QC chart;
2 - The saved date and time of the QC point at which the green vertical line lies;
3 - The QC points in each parameter QC chart are arranged from left to right and from old to new. All the QC
points are linked with lines, which makes it easy to view the distribution trend;
4 - The parameter QC results corresponding to the QC point at which the green vertical line lies;
5 - When clicking a QC point in the QC chart, mark this point and other QC points of the parameters, which
share the same save time, with green vertical lines;
6 - The QC point corresponding to each QC result. Only the values of the selected QC points can be
displayed under the parameter. If the QC point is black, it means its value is within the upper and lower limits;
If the QC point is red, it means its value is out of the upper and lower limit range;
7 - Relative positions of the QC point at which the green vertical line lies among all the QC points as well as
the number of QC points that are currently saved.

Note:

1. The value of QC point is the X-B QC analysis result of each group of sample
results.
2. Results that are out of control won't be included in the calculation of Mean, SD
and CV%.

8.4.4.1.2 Browsing results

If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

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Click or to move the green vertical line to the previous or next QC point; Click or

to move the green vertical line to the first or the last QC point of the QC chart. When the location of

the green vertical line is fixed, the area below each QC parameter name will display the QC result of the QC
point at which the green vertical line lies.

8.4.4.1.3 Delete

With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, please move the green vertical line to the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;

(3) Click the data you want to delete;


(4) Click OK and confirm. All the selected data will be deleted.

Note:

The deletion event will be recorded in the log.

8.4.4.2 QC list review

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.

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(1) Enter the QC chart interface in the following ways:

1. Click Menu on the interface and select QC  X-B QC in the pop-up menu;

2. Enter the X-B QC chart interface.

(2) Click QC List tab and enter the X-B QC list interface;

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(3) Drag the scroll bar below the QC list left and right to review all the QC results.

8.4.4.2.1 Introduction to the QC list interface

1 - QC results;
2 - QC result serial number saved in the QC files (arranged from left to right and from old to new);
3 - QC parameter (the display order is in accordance with the QC chart interface);
4 - QC warning signs:The results out of the set deviation limit range are marked with "↑" or "↓" for
prompting;

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5 - The relative location of highlighted QC results among all the QC results and the number of QC results
saved currently.

Note:

The value of QC result is the X-B QC analysis value of each group of sample results.

8.4.4.2.2 Browsing results

If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or , and the previous or the next QC result will be highlighted; Click or ,

and the first or the last QC result will be highlighted in the QC list.

8.4.4.2.3 Delete

With the administrator privilege, you may delete the QC results by following these steps:
(1) If you want to delete a single QC result, then click the column which contains the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;

(3) Click the data you want to delete;


(4) Click OK and confirm. All the selected data will be deleted.

Note:

The deletion event will be recorded in the log.

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8.4.4.2.4 Data export

If you want to export the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Export to provide the function of entering the file names of the exported path and related
data;

(2) Select the exported path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the exported data (default to: [X-B_QC_Data saved date_time]);
(4) Select the file type of the exported data.(Default to .CSV);
(5) Click OK and start exporting;

(6) The interface prompts that the exporting is finished. Click OK to exit.

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Note:

You can modify the exported data if necessary, but you cannot check it through
Historical Review function.

8.4.4.2.5 Data backup

If you want to backup the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Backup, and the function of entering the file names of backup path and data is provided;

(2) Select a backup path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);

(3) Enter the file name of the backup data (default to: [X-B_QC_Data saved date_time]);

(4) Click OK and start backup;

(5) The interface prompts that the backup is completed. Click OK to exit.

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Note:

1. The backup data cannot be modified. You can check it through Historical Review
function.

2. You can click Cancel on the progress bar to cancel the backup during the backup.

3. Please back up the data periodically.

8.4.4.2.6 Historical review

If you want to check the backup data, please follow the steps below:
(1) Click Historical Review and a dialogue box shown below will pop up;

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(2) Select the file name of the backup data you want to browse after selecting the directory where the backup
data exists;
(3) Click OK to display the selected backup data;

(4) The display forms of file information and result list as well as the button function are the same as the QC
list interface. If you want to view and print (not supported temporarily) the results in the list or export data,
you can refer to the operation methods in the QC list interface;
(5) Click Close to exit after reviewing.

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8.5 X -R QC

8.5.1 QC edit

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

Note:

Only the user of administrator level has the privilege to perform QC editing.

A QC file for each lot number of controls needs to be set before analysing a new batch of controls and the QC
information in the file can be edited through any one of the following methods.
Manual Entry.

8.5.1.1 Manual entry


(1) Enter the QC Chart interface by the following methods:
1. Click Menu on the interface, and select QC  X -R QC in the pop-up menu;

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2. Enter the X -R QC chart interface.

(2) Click Settings tab to enter X -R QC setting interface.

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Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

(3) Select a QC file number of which the QC information is empty;

Note:

The selecting range of file numbers is 1-60.

(4) Input the lot number of the controls in one of the following ways;
 Manual Entry
 Input by using an external barcode scanner (not supported temporarily)

Note:

1. The lot number cannot be null. The input range is 1-16 characters. Characters,
numbers, letters and special characters are allowed except Chinese.

2. The lot number and QC mode of the QC file cannot be the same
simultaneously.

(5) Input the batch expiry date of the controls;

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Note:

The input range of expiry date is [the current system date, 2099-12-31]. It cannot
be null.

(6) Select the QC mode for analysing the controls;

Note:

The lot number and QC mode of the QC file cannot be the same simultaneously.

(7) Select the level of controls;


(8) Click Save to save the input QC information.

8.5.2 QC analysis
You can select one of the following methods to perform QC analysis according to the QC mode selected after
editing the QC:
 Whole blood
 Predilution

8.5.2.1 QC analysis (whole blood)

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.

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Warnings:

1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase
the risks of biological problems. Please be careful when operating the uncovered
blood collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood
collection tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to keep them from injury.

5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical
mask, etc.) when touching reagent-related items in the library.

6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty
of water and seek medical treatment from a doctor.

Note:

Do not use disposable items repeatedly.

Note:

1. The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.
2. If the blood mode switches from "predilution" to "whole blood", the analyser
will execute mode switching fluidics sequence automatically and display the
progress bar prompt on the interface.

(1) Enter the QC Chart interface by the following methods:

1. Click Menu on the interface, and select QC  X -R QC in the pop-up menu;

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2. Enter the X -R QC chart interface.

(2) Click Counting tab to enter the X -R QC counting interface;

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Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:
1. Confirm that the QC mode is "whole blood" and the counting status icon and state light of the analyser are
green;
2. Shake the prepared controls as shown in the following figure to thoroughly mix it;

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3. Click Start QC Counting;

4. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
5. Press the counting button to initiate the QC analysis;

6. The buzzer rings when the absorption process is completed. The user can then remove the controls;
7. When the analysis is finished, the interface will display the QC results of the first analysis;

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8. When the controls are mixed again, please perform the second QC analysis according to the prompts on the
interface;

Note:

You can cancel the second QC analysis by clicking Cancel in the dialogue box.
And the first QC analysis results won't be saved.

9. The buzzer rings when the absorption process is completed. The user can then remove the controls.

(8) When the analysis is over, the QC results obtained (double the QC counting values and average values X ,

range R) will be displayed on the current interface and will be automatically saved in the current QC files;

Note:

1. When the second QC analysis results are obtained, the histogram and
scattergram displayed on the interface will be refreshed as the corresponding
figures of the second QC analysis results.

2. Each QC file can store 300 QC results (average values X and range R) at most.

(9) You may continue to perform QC analysis according to the steps above if necessary.

8.5.2.2 QC analysis (predilution)

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
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Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

Warnings:

1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase the
risks of biological problems. Please be careful when operating the uncovered blood
collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood collection
tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to keep them from injury.

5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical mask,
etc.) when touching reagent-related items in the library.

6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty of
water and seek medical treatment from a doctor.

Note:

Do not use disposable items repeatedly.

Note:

The operator must use disposable items specified by the company, such as vacuum
blood collection tubes, centrifuge tubes, capillaries, etc.

(1) Enter the QC Chart interface by the following methods:


1. Click Menu on the interface, and select QC  X -R QC in the pop-up menu;

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2. Enter the X -R QC chart interface.

(2) Click Counting tab to enter the X -R QC counting interface;

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Note:

Refer to Chapter 5 Settings for information about setting up a login user name.

(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:
1. Confirm that the QC mode is "predilution" and the counting status icon and state light of the analyser are
green;
2. Click Add Diluent in the shortcut button area and the following prompt box will pop up;

3. When the preparation is completed, the following dialogue box will pop up;

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4. Take a clean centrifuge tube. Insert the probe vertically into the bottom of the centrifuge tube after opening
the cover as shown in the following figure to avoid producing bubbles, suspending liquid or spilling while
adding diluent;

5. Press the counting button and start to add diluent;

6. The buzzer rings when the addition of diluent is completed. The user then can remove the centrifuge tube;
7. Collect 20μL of the controls and inject it into a centrifuge tube with diluent inside. Then fix the cover on
and thoroughly mix it;

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8. Click Cancel to exit the diluent addition dialogue box;

9. When the cleaning is completed, close the prompt;


10. Click Begin QC Counting;

11. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
12. Press the counting button to initiate the QC analysis;

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13. The buzzer rings when the absorption is completed. The user can remove the controls;
14. When the analysis is finished, the interface will display the QC results of the first analysis;

15. When the controls are mixed again, please perform the second QC analysis according to the prompts on
the interface;

Note:

You can cancel the second QC analysis by clicking Cancel in the dialogue box.
And the first QC analysis results won't be saved.

16. The buzzer rings when the absorption process is completed. The user can remove the centrifuge tube.

(8) When the analysis is over, the QC results obtained (double the QC counting values and average values X ,

range R) will be displayed on the current interface and will be automatically saved in the current QC files;

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Note:

1. Operators can also absorb 180μL diluent with a pipette.

2. Prevent dust from entering the prepared diluent, otherwise analysis errors may
arise.

3. After controls are fully reacted with the diluent, it needs to be laid for 3
minutes, and then mixed again before analysis.

4. Make sure to perform the analysis within 30 minutes after the sample is
diluted, otherwise the analysis results will be unreliable.

5. Samples that have been laid for a period of time need to be mixed again before
analysis.

6. Every laboratory should evaluate the stability of QC analysis results at the


predilution mode based on the respective number of samples, sample collecting
methods and technical levels.

7. Each QC file can store 300 QC results at most.

8. When the second QC analysis results are obtained, the histogram and
scattergram displayed on the interface will be refreshed as the corresponding
figures of the second QC analysis results.

9. Each QC file can store 300 QC results (average values X and range R) at
most.

(9) You may continue to perform QC analysis according to the steps above if necessary.

8.5.2.3 Browsing results


If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or to switch the current QC result to the previous one or the next one of the current

result. Click or to switch the current QC result to the earliest saved result or the newest saved

result in the QC file.

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Note:

1. Expired QC analysis results will be marked with the letter "O" before it.

2. If you have gained 10 groups of QC analysis results (obtained after 20 QC


analyses), when the gained QC average values X and range R are out of the
calculated deviation limit range, the average value X and range, R, will be
marked with the warning prompts of"↑" or "↓" before them..
3. The histogram of the interface also has the zoom function. Please refer to
Chapter 7 Result Review for its operation methods.

8.5.2.4 Print
Click Print and print the result on the current QC counting interface.

8.5.3 QC result review


When the QC analysis is completed, the user can review the QC results in the following two ways:
 QC chart
 QC list

8.5.3.1 QC chart review

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

(1) Enter the QC Chart interface by the following methods:


1. Click Menu on the interface, and select QC  X -R QC in the pop-up menu;

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2. Enter the X -R QC chart interface.

(2) Select the file number of the QC file you want to review, and the interface will display corresponding file
information and QC chart;
(3) Drag the scroll bar on the right of the QC chart up and down to review the parameter QC chart that you
want to review. Drag the scroll bar below the QC chart left and right to review all the QC results.

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8.5.3.1.1 Introduction to QC chart interface

1 - Average values (Mean), standard deviations (SD) and coefficients of variation (CV%) of all the QC results
of all the parameters in the current QC chart;
2 - The saved date and time of the QC point at which the green vertical line lies;
3 - The operator that performs QC analysis and obtains the QC point at which the green vertical line lies;
4 - The parameter QC results corresponding to the QC point at which the green vertical line lies;
5 - The QC points in each parameter QC chart are arranged from left to right and from old to new. All the QC
points are linked with lines, which makes it easy to view the distribution trend;
6 - The QC point corresponding to each QC result. Only the values of the selected QC points can be
displayed under the parameter. If the QC point is black, it means its value is within the upper and lower limits;
If the QC point is red, it means its value is out of the upper and lower limit range;
7 - When clicking a QC point in the QC chart, mark this point and the QC points of the parameters that are
saved at the same time with green vertical lines;
8 - Relative positions of the QC point at which the green vertical line lies among all the QC points as well as
the number of QC points that are currently saved.

Note:

1. The QC chart of each parameter is provided only when ten groups of QC


analysis results (obtained after 20 QC analyses) are obtained.

2. The values of QC points are the average value X and range, R, of each group
of the QC analysis result respectively.

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3. Results that are out of control won't be included in the calculation of Mean, SD
and CV%.

8.5.3.1.2 Browsing results

If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or to move the green vertical line to the previous or next QC point; Click or

to move the green vertical line to the first or the last QC point of the QC chart. When the location of

the green vertical line is fixed, the area below each QC parameter name will display the QC result of the QC
point at which the green vertical line lies.

8.5.3.1.3 New bottle

If the reviewed QC result is obtained from analysing the controls that are newly opened within the same
batch, the QC points of new bottles should be marked based on the following steps to differentiate the QC
analysis results of the controls in old bottles and new bottles:
(1) Move the green vertical line to the QC point of the first new bottle;
(2) Click New Bottle, and there will be a blue vertical line at the QC point of the new bottle;
(3) Open the controls within the same new bottle batch again and save its QC analysis results. Then click
Cancel New Bottle and cancel the original mark. And then mark the QC point of the new bottle according to
Step 1 and Step 2.

8.5.3.1.4 Data comparison

If you want to compare the QC charts of the same parameter in different batches of controls, please follow
the steps below:
(1) Click Data Comparison, and the selection of QC chart is provided;

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(2) Select the files numbers of QC files that you want to compare in the File Number box in turn (3 file
numbers at most). The corresponding QC chart of the selected file number is displayed below the file number,
and its batch, QC mode and level are also displayed;
(3) You can select the QC charts of different parameters in the Parameter box to compare as required.

Note:

The display form and view method of the QC chart are in accordance with the QC
chart interface. The lines connecting QC points are grey, black and orange so as to
differentiate the QC charts of different levels of controls.

(4) If you want to print the currently compared parameter QC chart, please click Print (not supported
temporarily);
(5) Click Close to exit.

8.5.3.1.5 Display sequence

If you want to change the display sequence of different parameter QC charts, please follow the steps below:
(1) Click Display Sequence, and the display sequence of the current QC charts will be provided;

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(2) Click the parameter that is desired to adjust the display order of the QC chart;

(3) Click or to move this parameter forward or backward; Click or

to move this parameter to the beginning or end;


(4) Click OK and the display sequence of QC chart will be refreshed.
8.5.3.1.6 Entering the reason for loss of control

If you want to enter why the QC point is out of control, please follow the steps below:
(1) Click Out of Control after moving the green vertical line to the QC point desired to enter the reason for
loss of control. It will display the QC results, reference values and deviation limits of all parameters where
the green vertical lines lie (QC results that exceed the range of upper and lower limits will be marked in red)
and provide the function of entering the reason for loss of control;

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(2) The reason for loss of control can be selected from a list of provided reasons. Or one can manually enter
the reason for Loss of Control (200 characters max.) in the edit box after clicking the Others option;
(3) Click OK to save the entered reason for loss of control and exit.

Note:

After entering the reason for loss of control for a set of QC points of which the QC
results of parameters are within the deviation limits, the whole set of QC data will
be all marked in red that correspond to this set of QC points in QC chart/QC list. If
the reason for loss of control is cancelled and saved, the corresponding whole set of
QC data will be recovered and shown as black again.

8.5.3.1.7 Delete

With the administrator privilege, you may delete the QC results by following these steps:
(1) If you want to delete a single QC result, please move the green vertical line to the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;

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(3) Click the data you want to delete;
(4) Click OK and confirm. All the selected data will be deleted.

Note:

The deletion event will be recorded in the log.

8.5.3.2 QC list review

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

(1) Enter the QC list interface by any one of the following methods:
1. Click QC in the shortcut button area;
2. Click Menu on the interface, and select QC  X -R QC in the pop-up menu;

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3. Enter the X -R QC chart interface.

(2) Click QC List tab to enter the X -R QC list interface;

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(3) Select the file number of the QC files you want to review, and the interface will display corresponding file
information and QC list;
(4) Drag the scroll bar on the right of the QC list up and down to review the parameter QC result you want to
review. Drag the scroll bar below the QC list left and right to review all the QC results.

8.5.3.2.1 Introduction to the QC list interface

1 - Serial number of QC results saved in QC files (arranged from left to right and from old to new);
2 - QC results;

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3 - QC parameter (the display order is in accordance with the QC chart interface);
4 - QC warning signs:If you have gained 10 groups of QC analysis results (obtained after 20 QC analyses),
the results (average values X ) that are out of the set deviation limit range will be marked with an "↑" or "↓"
for prompting;
5 - The relative location of highlighted QC results among all the QC results and the number of QC results
saved currently.

Note:

1. The grand mean, average range and warning prompt of each parameter are provided
only when 10 groups of QC analysis results (obtained after 20 QC analyses) are
obtained.
2. The values of QC results are the average values X and range R of each group of the
QC analysis results.

8.5.3.2.2 Browsing results

If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:

Click or , and the previous or the next QC result will be highlighted; Click or ,

and the first or the last QC result will be highlighted in the QC list.

8.5.3.2.3 Delete

With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, then click the column which contains the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;

(3) Click the data you want to delete;


(4) Click OK and confirm. All the selected data will be deleted.

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Note:

The deletion event will be recorded in the log.

8.5.3.2.4 Data export

If you want to export the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Export to provide the function of entering the file names of the exported path and related
data;

(2) Select the exported path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the exported data (default to: [Xaverage value-R_QC_Data saved date_time]);
(4) Select the file type of the exported data.(Default to .CSV);
(5) Click OK and start exporting;

(6) The interface prompts that the exporting is finished. Click OK to exit.

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Note:

You can modify the exported data if necessary, but you cannot check it through
Historical Review function.

8.5.3.2.5 Data backup

If you want to backup the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Backup, and the function of entering the file names of backup path and data is provided;

(2) Select a backup path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);

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(3) Enter the file name of the backup data (default to: [Xaverage value-R_QC_Data saved date_time]);
(4) Click OK and start backup;

(5) The interface prompts that the backup is completed. Click OK to exit.

Note:

1. The backup data cannot be modified. You can check it through Historical Review
function.

2. You can click Cancel on the progress bar to cancel the backup during the backup.

3. Please back up the data periodically.

8.5.3.2.6 Historical review

If you want to check the backup data, please follow the steps below:
(1) Click Historical Review and a dialogue box shown below will pop up;

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(2) Select the file name of the backup data you want to browse after selecting the directory where the backup
data exists;
(3) Click OK to display the selected backup data;

(4) The display forms of file information and result list as well as the button function are the same as the QC
list interface. If you want to view and print (not supported temporarily) the results in the list or export data,
you can refer to the operation methods in the QC list interface;
(5) Click Close to exit after reviewing.

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8.6 Repeatability
Please follow the following steps to compete the repetitive operation:
(1). Click Menu on the interface, and select QC  Repeatability in the pop-up menu;

Enter the repeatability interface.

(2) Click Start and the following dialogue box will appear:

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(3) Select the blood mode that needs to undergo a repeatability test; click OK and a dialogue box will pop up.

Press the counting button on the analyser and the progress bar dialogue box will pop up.

Note:

Once the operator clicks Start and presses the counting button to start the first
counting, the Start button turns grey. After this, the operator can press the
counting button on the analyser directly and continue the repetitive counting.

(4) If the operator switches the interface before calculating new reproducibility, a prompt dialogue box will
pop up.

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Click Yes, and the existing repetitive statistics will be abandoned. Close the prompt dialogue box and switch
to another interface. The original reproducibility won't be changed.
(5) When effective repetitive counting accumulatively reach n times (n ≥ 4), the analyser will automatically
calculate average values Mean, SD and CV% of all the repetitive data selected by “√” (the calibration data for
the first counting has no “√”, so it won't be calculated);
(6) When obtaining new reproducibility, please follow the steps shown below:

8.6.1 Save
(1) Click Save and a dialogue box will pop up:

(2) Click OK and close the dialogue box.

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8.6.2 Data export
(1) Click Data Export and a dialogue box will pop up:

(2) Select a path for exporting the data. Click Save and a dialogue box will pop up:
(3) Click OK and close the dialogue box.

Note:

You can modify the exported data if necessary, but you cannot check it through
Historical Review function.

8.6.3 Exit
(1) Click Exit and a prompt dialogue box will pop up:

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(2) Click Yes, save the reproducibility, and a prompt dialogue box will pop up:

(3) Click Yes, exit the current repetitive interface and switch to another interface.

8.7 Carrier Rate


Complete the counting operation of carryover according to the following steps:
(1) Click Menu in the interface, and select QC  Carrier Rate in the pop-up menu;

Enter the Carrier Rate interface.

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(2) Click Start and the following dialogue box will appear:

(3) Press the counting button on the analyser, and the information/status bar will show that the carryover is
being calculated;

Note:

Once the operator clicks Start and presses the counting button to start the first
counting, the Start button turns grey. After this, the operator can press the counting
button on the analyser directly and continue the carryover counting.

(4) Perform blood sample counting 3 times first, and then perform diluent counting 3 times. The analyser
will calculate the carryover automatically based on formulas;
(5) The carryover is calculated. Then judge the state according to the diluent range and carryover range:

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8-115
Calibration

Chapter 9. Calibration

9.1 Overview
Like all the other measuring instruments, LW D6500 Five-differential Haematology Analyser must be
calibrated periodically. Performing calibration is to get correct measuring results and determine the offset
correction factor of the blood sample analysis at prescribed conditions. To get correct blood sample analysis
results, the analyser should be calibrated according to the steps given in this chapter if needed.

Note:

1. Only operators with administrator privileges can perform calibrations.

2. The operator should use the controls and reagents specified by the company, and
store and use them in strict accordance with the manual.

3. Only the calibrators counting performed in the calibration interface can be


counted as part of calibration operations.

4. Repetitiveness counting should also be included in the calibration steps.

9.2 Calibration frequency


This analyser had been calibrated before leaving the factory. Due to its stable performance, the analyser
doesn’t need to be calibrated often. However, the operator should calibrate the analyser in the following four
situations:
(1) Before the first use;
(2) After replacing main parts;
(3) Return to use the analyser when it hasn't been used for a long time;
(4) When the QC data shows systematic errors (deviation) or the data surpasses pre-defined limits.

Note:

The measuring data can be used effectively only after the analyser is calibrated.

9-1
Calibration

9.3 Calibration method


This analyser provides three kinds of calibration methods:Manual calibration, calibrator calibration, and fresh
blood calibration.
It can calibrate all or part of the parameters of WBC, RBC, HGB, MCV and PLT.

9.3.1 Preparation
Perform inspection according to the following steps before calibration. The calibration can only be performed
when the normal background, Reproducibility and carryover of the analyser are confirmed within the
manual-specified ranges. Otherwise, you must find out the reasons and then decide whether calibration needs
to be performed when the problem is solved. If the problem cannot be solved, please contact with the
after-sales service department of Landwind Company.
(1) Check the analyser and reagents, and make sure that the amount of the reagent is sufficient to complete
the whole calibration. If the reagent is used up during the calibration, you need to recalibrate.
(2) When performing the background test, if the "Abnormal background" prompt appears at the bottom of the
screen, please refer to Chapter 11 Troubleshooting for handling so as to make sure the results of the
background test meet requirements. (Refer to Appendix B Specifications for normal background).
Perform 11 times of counting in a row in the whole blood -CBC+DIFF pattern with median controls. Take the
counting results from the second to the eleventh, and view the repetitiveness of counting results from the
second to the eleventh in List Review interface to make sure that the repetitiveness are within the range
specified by the table below.
Parameters Ranges Repetitiveness Repetitiveness
of whole blood of prediluted sample
sample (CV) (CV)

WBC (4.0 - 15.0)×109/L ≤2.0% ≤4.0%

RBC (3.50 - 6.00)×1012/L ≤1.5% ≤3.0%

HGB (110 - 180)g/L ≤1.5% ≤3.0%

MCV (70 - 120)fL ≤1.0% ≤2.0%

PLT (150 - 500)×109/L ≤4.0% ≤8.0%

(3) Count 3 times with high value controls, and count 3 times immediately with matched diluent. Then
calculate the carryover according to the formula below.

Carryover (%) = the first sample result wit h low value - the third sample result wit h low value
 100%
the third sample result wit h high value - the third sample result wit h low value

Its result should meet the requirements in the table below.

Parameters Carryover

9-2
Calibration

WBC ≤0.5%

RBC ≤0.5%

HGB ≤0.5%

HCT ≤0.5%

PLT ≤1.0%

(4) We recommend that the operator creates a log file, turns it into a log sheet and saves it. The contents of
the log sheet is recommended to include the following items:Date, calibrators source, lot number and its
reference value, as well as background test value.

Biological risk:

All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

Warnings:

1. Probe head is pointed. Blood samples, controls and calibrators on the probe have
a potential of biological infectivity. Avoid touching the probe.
2. The reagent will cause irritation to eyes, skin and mucous membranes. Operators
should observe laboratory safety operation rules and wear personal protective
equipment (such as laboratory protective clothing, gloves, surgical mask, etc.)
when touching reagent-related items in the library.
3. If the reagent touches the skin, please wash the affected area immediately with
plenty of water and seek medical treatment if necessary. If the reagent gets in
contact with the eyes, please wash them immediately with plenty of water and seek
medical treatment from a doctor.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to prevent injuries.

5. Operators have an obligation to observe the relevant provisions of the region and
country when discharging and disposing of expired reagents, wastes, waste
samples, consumables, etc.

Note:

9-3
Calibration

Do not use disposable items repeatedly.

Note:

1. The operator should use the calibrators and reagents specified by the company,
and store and use them in strict accordance with the manual.
2. The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.

9.3.2 Manual calibration


Complete the manual calibration according to the following steps:
(1) The operator clicks Menu, selects Calibration and enters Calibration Factor interface. The Calibration
Factor interface displays the calibration factors of whole blood patterns and predilution patterns by default.

Note:

The operator logged in with a common user identity can only view the calibration
factors of the current interface and cannot perform calibration. If he wants to
calibrate the analyser, he should log out, and log in again with the administrator
identity.

(2) The operator enters Calibration Factor interface to view the calibration factor and calculate new
calibration factors for each calibration factor using the following formulas.

9-4
Calibration

current calibratio n coefficien t  reference value


New calibratio n coefficien t =
measured average value

For example:Suppose that the WBC reference value of calibrators is 8.4, and the calibration factor of the
current whole blood mode is 98.90%.
Measure the WBC parameter of the calibrators in the whole blood mode 11 times. Take the results from the
second to the eleventh (n=10), with the results of 8.1, 8.0, 8.1, 8.1, 8.3, 8.3,8.2, 8.0, 8.1 and 8.3, and obtain
the reproducibility, CV=1.5%, Mean=8.16. The requirements are met, and the measured average value is
effective.
Calculate new calibration factor:

98.90%  8.4
New calibratio n coefficien t = =101 .81%
8.16

If the calculated calibration factor of a parameter is out of the effective range (75.00% - 125.00%), the
coefficient is ineffective. In this case, the operator should find out the reason (the sample hasn't been fully
mixed or incorrect operation, etc). Calibrate again and calculate the calibration factor.

Note:

The input calibration factor should be in the range of 75.00% - 125.00%, and
only two decimal digits are retained.

(3) After getting a new calibration factor, the operator inputs the new calibration factor in the calibration
factor cell that needs to calibrate parameters:
(4) After inputting the new calibration factor, click Save below the interface. If the new calibration factor is
effective, and the value is not the same as the original one, a prompt dialogue box will pop up.

Click OK and save the new calibration factor. Meanwhile, the calibration date of the corresponding
calibration parameter is refreshed to the current system date. Then close the prompt dialogue box above,
return to the calibration factor surface, and don't highlight any cells.
If the new calibration factor is ineffective, click Save and a prompt dialogue box will pop up.

9-5
Calibration

Click OK and close the prompt dialogue box. Highlight the cell of the first ineffective calibration factor. Edit
the data in it, but don’t empty it.
(5) If you switch the interface before clicking Save when the calibration factor is modified, a corresponding
prompt will appear when you exit.
If the new calibration factor is effective, a prompt dialogue box will pop up when you exit the interface.

Click OK and save the new calibration factor. Meanwhile, the calibration date of the corresponding
calibration parameter is refreshed to the current system date and recorded into the calibration history. Then
close the prompt dialogue box and switch to another interface.
If the input calibration factor is ineffective, a prompt dialogue box will pop up when you switch the interface.

Click OK and close the prompt dialogue box. Switch to another interface directly and don't save the modified
calibration factor and corresponding calibration date, that is, the calibration factor and date are the values
displayed when entering the calibration factor interface.

9-6
Calibration

9.3.2.1 Other operations


 Restore
Click Restore and restore the calibration factor to the value displayed when entering the calibration factor
interface.

9.3.3 Calibrators calibration


Complete the calibrators calibration according to the following steps:
(1) The operator clicks Menu, selects Calibration and enters Calibration Factor interface;
(2) Click Calibrators Calibration tab on the top of Calibration Factor interface, and enter Calibrators
Calibration interface.

Note:

1. The default expiry date of the analyser is the current system time.

(3) Input the lot number of the current calibrators in Lot Number edit box;
(4) Set the expiry date. The default reagent expiry date of the analyser is the current date. If you want to
modify it, please click Expiry Date edit box to reset it;
(5) Select the parameter that needs to be calibrated in the check box of the first line of the list;

9-7
Calibration

(6) Input the target value of the parameter that needs to be calibrated in the edit box corresponding to Target
Value.

Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.

Note:

1. The operator must use the calibrators specified by the company and dedicated to
this analyser. The company won't be responsible for incorrect analysis results caused
by using other calibrators.
2. Refer to the operation manual of calibrators for its lot number, expiry date and
parameter target value.
3. The lot number cannot be null.
4. The expiry date cannot be less than the current system date.
5. The expiry date entered by the operator should be the expiry date of calibrators
opening date + date after seal of calibrators, or the expiry date specified on the
operation manual of calibrators. If these two are unequal, choose the smaller one to
make sure that the calibrators are always within the expiry date range when using.

(7) Prepare the calibrators according to the operation instruction;


(8) After clicking Start Calibration Counting, press the counting button on the analyser, initiate the
calibration counting fluidics sequence, and a progress bar dialogue box will pop up.

Note:

Once the operator clicks Start Calibration Counting and presses the counting
button to start the first counting, the Start Calibration Counting button turns grey.

9-8
Calibration

After this, the operator can press the counting button on the analyser directly and
continue the calibration counting.

(9) When each calibration counting is finished, the progress bar dialogue box of calibration counting will
close automatically. The analyser will perform different processing depending on different calibration
counting results;
Among the current counting, if the calibration counting data of a parameter is out of its linearity range but
within the display range, then the calibration data will be displayed in the list and a prompt dialogue box will
pop up.

Click OK and the dialogue box closes. The calibration data displayed in the list this time will be deleted
automatically and the calibration data won’t be saved this time.
Among the current counting, if the calibration counting data of a parameter is out of its display range, it is
displayed as *** (*** is displayed based on the data format of each parameter) in the list. Meanwhile, a
prompt dialogue box will pop up.

Click OK and the dialogue box closes. The calibration data displayed in the list this time will be deleted
automatically and the calibration data won’t be saved this time.
If the calibration counting result is within the linearity range, it is recognized as effective and will be
displayed directly.

9-9
Calibration

Note:

When an effective calibration counting result is obtained, the check box before it
will turn into “√” state. It will be included in the calibration factor calculation by
default.
(10) If the operator switches the interface before calculating new calibration factor, a prompt dialogue box
will pop up;

Click Yes, and the existing calibration data will be abandoned. Close the prompt dialogue box and switch to
another interface. The original calibration factor won't be changed.
(11) When effective calibration counting accumulatively reaches n times (n ≥ 6), the analyser will
automatically calculate average values Mean, CV% and new calibration factors (the calibration data for the
first counting has no “√”, so it won't be calculated) of all the calibration data selected by “√”;
The operator can select several groups of data to calculate the calibration factor. However, the calibration
factor can only be calculated when the number of the data groups selected by “√” is above 5. When clicking
the “√” of the check box or .cancelling the data with “√”, the calibration factor will be refreshed and
displayed in time.

Note:

1. If the CV% value is over the limit, it won't affect the display of the calibration
factor.
2. When the number of the effective calibration data points in the list reaches 11,
"The calibrators calibration this time has been fully completed!" will pop up
immediately. If one alarm sound emits "Tick" after the counting button on the
analyser is pressed, the counting won't be responded.

(12) When a new calibration factor is obtained, the operator switches the interface. Several situations are
distinguished as follows:
If the calibration factor of any parameter that has been calculated and needs to be calibrated is out of the
range of 75%-125%, i.e. <75% or >125%, or the CV% value of any calibration parameter exceeds the
reproducibility of the analyser, then the coefficient values of all the parameters that need to be calibrated
won't be saved, and a prompt dialogue box will pop up.
9-10
Calibration

Click Yes, close this prompt dialogue box and switch to another interface. Meanwhile, the calibration factor
and calibration date of each calibration parameter isn't modified.
If all the calculated calibration factors are within the range of 75%-125% (i.e. >=75% and <=125%), and the
CV% values of all calibration parameters don't exceed the reproducibility of the analyser, a prompt dialogue
box will appear.

Click Yes to save the calibration factor


.

9.3.4 Fresh blood calibration


Complete the fresh blood calibration according to the following steps:
(1) The operator clicks Menu, selects Calibration and enters Calibration Factor interface;
(2) Click Fresh Blood Calibration tab on the top of the Calibration Factor interface, and enter Fresh
Blood Calibration interface;

9-11
Calibration

(3) Refer to the sample preparation methods in Chapter 6 Daily operation and prepare 3 - 5 shares of normal
fresh blood samples;
(4) Take 3 - 5 shares of prepared normal fresh blood, and measure them at least 3 times on the reference
instrument respectively. Calculate the average values, and turn the average values into reference values; Or
conduct measurements and calculations based on the reference method, and consider the obtained data as
reference values;
(5) Click the two radio buttons of Whole blood and Predilution on the top of the interface, and select a
calibration mode of fresh blood calibration;

Note:

If counting is performed in the calibration mode of "Predilution", then when the


calibration mode switches from "predilution" to "whole blood", the analyser will
execute mode switch fluidics sequence automatically and show the progress bar
prompt on the interface.

(6) Select the number of the current calibration blood samples in the drop-down list box of Current Blood
Sample ID;
(7) Select the parameter that needs to be calibrated in the check box of the first line of the list;
(8) Input the reference value of the parameter that needs to be calibrated in the edit box corresponding to the
Reference Value.
(9) Prepare the fresh blood samples of whole blood or predilution;
(10) After clicking Start Calibration Counting, press the counting button on the analyser, initiate the
calibration counting fluidics sequence, and a progress bar dialogue box will pop up;

9-12
Calibration

Note:

Once the operator clicks Start Calibration Counting and presses the counting
button to start the first counting, the Start Calibration Counting button turns grey.
After this, the operator can press the counting button on the analyser directly and
continue the calibration counting.

(11) When each calibration counting is finished, the progress bar dialogue box of calibration counting will
close automatically. The analyser will perform different processing depend on different calibration counting
results;
If the calibration counting result is out of the linearity range but within the display range, the calibration
counting result will be displayed in the list, and meanwhile, a prompt dialogue box will pop up.

Click OK and the dialogue box closes. The calibration result displayed in the list this time will be deleted
automatically and the calibration result won’t be saved this time.
If the calibration counting result is out of the display range, the calibration counting result in the list will be
displayed as *** (*** is displayed according to the data format of each parameter) and a prompt dialogue box
will pop up.

9-13
Calibration

Click OK and the dialogue box closes. The calibration result displayed in the list this time will be deleted
automatically and the calibration result won’t be saved this time.
If the calibration counting result is within the linearity range, it is recognized as effective and will be
displayed directly.

Note:

When an effective calibration counting result is obtained, the check box before it will
turn into “√” state. It will be included in the blood sample calibration factor
calculation by default.

(12) For each blood sample, when effective calibration counting accumulatively reaches n times (n ≥ 6), the
analyser will automatically calculate average values Mean, CV% and blood sample calibration factors (the
calibration data for the first counting has no “√”, so it won't be calculated) of all the calibration data selected
as indicated by “√”;
The operator can select several groups of data to calculate the blood sample calibration factor. However, the
blood sample calibration factor can only be calculated when the number of the data groups selected as
indicated by “√” is above 5. When clicking the “√” of the check box or cancelling the data with “√”, the
blood sample calibration factor will be refreshed and displayed in time.

Note:

1. If the CV% value is over the limit, it won't affect the display of the blood sample
calibration factor.
2. When the number of the effective calibration data in the list reaches 11, " The
calibrators calibration this time has been fully completed!" will pop up immediately.
If one alarm sound emits "Tick" after the counting button on the analyser is pressed,
the counting won't be responded.

(13) Select other calibration blood samples in the drop-down list box of Current Blood Sample ID,
complete the counting of other calibration blood samples referred to in Step 8 - Step 12 found above, and
obtain the calibration factor of each blood sample.

9-14
Calibration

Note:

If you have selected some parameters to calibrate, then when switching to other
blood sample, the grey parameter column will remain grey.

(14) Switch blood samples. Several situations are distinguished as follows:


If the calculated calibration factor of a blood sample is out of effective range, or the CV% value of any
calibration parameter doesn't exceed the reproducibility of the analyser, a prompt dialogue box will appear
when selecting other blood sample.

Click Yes, and empty the input reference values of the current blood sample, all the existing calibration data
and all the counting values, including calibration factors. Then close the prompt dialogue box, and switch to
other blood samples.
If new calibration factor of this blood sample hasn't been calculated, a prompt dialogue box will pop up.

Click Yes, and empty the input reference values and all the existing calibration data. Then close the prompt
dialogue box, and switch to other blood samples directly.
If the calibration factor of this blood sample is within the effective range, and the CV% values of all
calibration parameters don't exceed the reproducibility of the analyser, then direct switching is allowed, and
no prompt will pop up.
(15) Click Calculation in the interface to enter the fresh blood calibration calculation interface after
obtaining at least 3 calibration factors of fresh blood samples;

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Calibration

Click the check box in front of each blood sample calibration factor, then select or cancel the calibration
factor of the blood sample for the calculation of average calibration factor.
When the calibration factors selected with “√” are greater than or equal to 3 groups, the CV% value among
the calibration factors will be recalculated according to the calibration factors selected with “√”.

Note:

The CV% value will not affect the display of the average calibration factor no matter
whether it is above limit or not.

When the calibration factors selected with “√” are greater than or equal to 3 groups, the average calibration
factor will be recalculated automatically according to the current calibration factors selected with “√”.
(16) If the average calibration factor has not been calculated, then a dialogue box will pop up when switching
from the fresh blood calibration interface or calibration mode.

Click Yes to abandon the existing calibration data and close the prompt dialogue box to switch to another
interface or calibration mode. The original calibration factor and date will not be changed.
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Calibration

(17) If the calculated average calibration factor is within the effective range, a prompt dialogue box will pop
up when switching from the fresh blood calibration interface, or calibration mode.

Click Yes to save the current average calibration factor and the calibration factor and calibration date in the
calibration factor list in the "Calibration Factor" interface will automatically be updated at the same time. And
then switch to another interface or calibration mode; Click No so the average calibration factor and all the
calibration data will not be saved. Close the prompt dialogue box directly, switch to another interface or
calibration mode.

9.3.5 Verify calibration factor


The calibration factor is required to be verified after calibration. It is recommended to following the steps
below:
(1) The calibrators should be analysed at least 3 times and checked whether the analysis result is within the
allowable range;
(2) Controls of high, medium and low values should be analysed, with each concentration measured at least 3
times and checked whether the analysis result is within the allowable range;
(3) Normal fresh blood samples with at least 3 known reference values should be analysed. Each sample
should be measured at least 6 times and checked whether the analysis result is within the allowable range.

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Services

Chapter 10. Services

10.1 Overview
To ensure the analyser can run accurately and effectively, operators should conduct daily maintenance on the
analyser according the requirements in this chapter. This analyser provides several maintenance functions to
help the operators complete the maintenance.
This chapter introduces the maintenance functions of the analyser and some handling measures adopted
should failures and alarms happen.

Biological risk:

The surfaces of all the analyser components are potentially infectious. Safety
protection measures should be taken during operations and maintenance.

Cautions:

1. Improper maintenance may damage the analyser. Operators must conduct


maintenance according to the instructions in the operating manual.

2. Please contact the after-sales department of Landwind Company should problems


be encountered that are not specified in the manual. The designated professionals of
Landwind Company will provide maintenance suggestions.

3. The analyser must be maintained using the spare parts provided by Landwind
Company. Please contact the after-sales department of Landwind Company should
there be any question.

4. Please avoid touching the sharp needlepoint of the probe during maintenance.

10.2 Maintenance

10.2.1 Manual sleep


If the analyser will not be used for a known period of time, the sleep function can be initiated manually.

Note:

1. The analyser will not enter sleep during self-testing of motor, self-testing of valve
or in status interface.

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Services

2. The analyser will not enter sleep should there be any failure affecting the sleep.

Click Menu in the interface and select Instrument  Instrument Sleep in the pop-up menu.

Prepare to enter sleep.

When the sleep preparation has been completed, the progress bar dialogue box in the figure above will close
automatically and the analyser will enter sleep.

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Note:

1. The counting status icon in the interface will stay as yellow after the analyser has
entered sleep. The state light on the analyser will also stay as red at this time.

2. Sample analysis cannot be performed when the analyser has entered sleep.

3. Operations not related to the analyser, such as communications, printing, etc.,


will not be affected after the analyser has entered sleep.

4. The analyser will not enter sleep status should there be any failure during the
sleep process and failure will be reported at the same time. Please refer to Chapter
11 Troubleshooting for troubleshooting methods.

10.2.2 Exit sleep

Note:

The analyser will perform different levels of maintenance when exiting sleep
according to the duration of sleep time. Meanwhile, the maintenance time will be
different.

The analyser can exit sleep by the following two methods.


 Instrument Wake-up button;
Click Menu in the interface and select Instrument  Instrument Wake-Up in the pop-up menu.

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Services

A dialogue box will pop up as shown below to cancel sleep.

After cancelling the sleep, the progress bar dialogue box in the figure above will close automatically, and the
analyser will exit sleep.
 Counting button
Press the counting button on the analyser directly to cancel the sleep.

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Services

After waking up the instrument, the progress bar dialogue box in the figure above will close automatically,
and the analyser will exit sleep.

Note:

1. Please refer to Chapter 11 Troubleshooting for troubleshooting methods should there


be any failure when cancelling sleep.

2. The analyser will restore to the status before the sleep automatically after exiting sleep
normally. The counting status icon in the interface will stay as green at this time. The
state light on the analyser will also stay as green at the same time.

10.2.3 Reagent replacement

Warnings:

1. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical mask,
etc.) when touching reagent-related items in the library.
2. If the reagent has made contact with skin, please flush the affected area with
plenty of water immediately and seek a doctor’s treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty of
water and seek medical treatment from a doctor.

Note:

1. Stand the reagent for some time to stabilize it before using.


2. Operators should perform a background test after replacing diluent or lyse to
ensure the background value is within normal range and prepare for sample
analysis.

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Services

In the following situations, Users need to replace reagents in the following situations:
 Replace new reagents;
 Suspect the reagent tube has been polluted;
 Reagent has been polluted or expired;
 Suspect there is bubble in the tube.

Click in the shortcut button area or click Menu. Select Service  Maintenance -> Reagent
Replacement in the pop-up menu and enter the interface as shown in the figure below.

Users can replace the following reagents:


 L-65D Diluent
 L-65LEO I LYSE
 L-65LEO II LYSE
 L-65LH LYSE
The steps to replace the reagent are as shown below:
(1) Click the reagent icon to be replaced and a dialogue box will pop up as shown below:

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Services

Note:

1. The expiry date cannot be blank.


2. The input range of the reagent lot number is 1-16 characters and can be blank.
3. The expiry date of reagent can be input with an external barcode scanner after
selecting Scan with Barcode in the dialogue box (not supported temporarily).

(2) The lot number and expiry date of the reagent to be replaced can be input after clicking Replace New
Bottle radio button:
(3) Click OK, save the input expiry date and lot number, and begin to replace the reagent:
(4) The operation/status information bar will prompt that the reagent replacement is done upon completion:
(5) You can continue to replace other reagents according to the steps above if necessary.

10.2.4 Cleaning
Users are required to clean the corresponding components in the following situations:
 The WBC cuvette can be cleaned if the background results of WBC and (or) HGB exceed the normal
background;
 The RBC cuvette can be cleaned if the results of RBC and (or) PLT exceed the normal background;
 The DIFF cuvette can be cleaned if there are many particles in the scattergram of the background
results;
 The flow cell can be cleaned if there are many particles in the scattergram of the background results or
the results of WBC classifications are not satisfying;
 The probe can be cleaned if it is dirty.

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Services

Click in the interface, then click Clean tab in the pop-up interface and enter the interface as shown
below.

Users can clean the following components:


 DIFF cuvette
 WBC cuvette
 RBC cuvette
 Flow cell
 Probe
The cleaning steps are as shown below:
(1) Click the icon of the component to be cleaned to start cleaning this component;
(2) The operation/status information bar will prompt that the cleaning has successfully been completed;
(3) You can continue to clean other components according to the steps above if necessary.

10.2.5 Maintenance
The maintenance of the instrument includes: The rear of cuvette branch cell cleanser immersion, unclogging
apertures, zapping apertures, flushing apertures, DIFF cuvette immersion, WBC cuvette immersion, RBC
cuvette immersion, whole machine cell cleanser immersion, DIFF cuvette emptying, WBC cuvette emptying,
RBC cuvette emptying, etc.
10.2.5.1 The rear of cuvette branch cell cleanser immersion
Users can perform The rear of cuvette branch cell cleanser immersion immersion in the following situations:

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Services

 When the instrument has performed counting for about 1500 times;
 After the clogged apertures have been solved.

Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.

The rear of cuvette branch cell cleanser immersion is as shown below:


(1) Click Rear of Cuvette Branch Cell Cleanser Cmmersion icon and a dialogue box will pop up as shown
below:

(2) Click Yes and a prompt dialogue box will pop up. Please place the cell cleanser under the probe and press
the counting button;

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Services

(3) After absorbing the cell cleanser as prompted, a progress bar dialogue box will pop up as shown below
and the absorption of cell cleanser will begin;

10.2.5.2 Unclogging apertures


If a aperture is clogged the counting result is incorrect, or apertures are suspected to be clogged, then
unclogging apertures can be performed.

Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.

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Services

The steps of unclogging apertures are as shown below:


(1) Click Unclogging Apertures icon to start removing the blockage;
(2) The operation/status information bar will prompt that unclogging apertures have successfully been
completed;
(3) You may continue to unclogging apertures according to the steps above if necessary.
10.2.5.3 Zapping apertures
Users can perform zapping apertures if there are any clogged apertures. Zapping apertures can be performed
several times as it does not consume reagents.

Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.

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Services

The steps for apping apertures are as shown below:


(1) Click Zapping Apertures icon to start zapping apertures;
(2) The operation/status information bar will prompt that zapping apertures have successfully been
completed;
(3) You may continue to perform zapping apertures according to the steps above if necessary.
10.2.5.4 Flushing apertures
Users can perform flushing apertures if there are any clogged apertures

Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.

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Services

The steps for flushing apertures are as shown below:


(1) Click Flushing Apertures icon to start flushing apertures;
(2) The operation/status information bar will prompt that flushing apertures has successfully been completed;
(3) You may continue to perform flushing apertures according to the steps above if necessary.

10.2.5.5 Cell cleanser immersion


Users can perform cell cleanser immersion in the following situations:
 If the background results are beyond the normal background, the effect of scattergram classification is
reduced, or a clogged happens while the problems are still persistent after performing other maintenance
operations;
 If the amount of sample is large (more than 300 samples/day), the analyser will prompt to perform an
additional whole machine cell cleanser immersion to prevent pollutants from accumulating inside the
machine besides performing whole machine cell cleanser immersion during daily shutdown (as a certain
degree of accumulation will cause serious impact on the results as well as the machine itself!) and ensuring
the accuracy of the results;
 If the amount of sample is small (less than 20 samples/day), the analyser will also perform whole machine
cell cleanser immersion during daily shutdown to prevent pollutants from accumulating inside the machine
(as a certain quantity of accumulation will cause serious impact on the results as well as the machine itself!)
and ensuring the accuracy of the results.

Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.

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Services

The steps for cell cleanser immersion are as shown below:


(1) Click Cell Cleanser Immersion icon and a dialogue box will pop up;

(2) Click Yes and a prompt dialogue box will pop up. Please place the cell cleanser under the probe and press
the counting button;

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Services

(3) After absorbing the solution for the first time as prompted, a progress bar dialogue box will pop up as
shown below and the absorption of cell cleanser will begin;

(4) The progress bar dialogue box will close automatically and a prompt dialogue box will pop up at the same
time;

(5) The operation/status information bar will indicate that the instrument is immersing in the cell cleanser
after absorbing the cell cleanser for the second time. Please wait for a moment;
(6) The option to stop the immersion manually will pop up after 5 minutes. Click Stop Immersion or wait for
the instrument to finish the immersion automatically;

(7) The immersion will continue for 20 minutes. The operation/status information bar will then prompt that
probe immersion has successfully been completed;

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Services

(8) You may continue to perform cell cleanser immersion according to the steps above if necessary.

10.2.5.6 DIFF cuvette immersion


The functions of DIFF cuvette immersion as act as a troubleshooting means when the apertures are blocked,
the single channel signal is bad, common unclogging is required or DIFF channel causes abnormal
scattergram.

Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.

The steps for cell cleanser immersion of DIFF cuvette are as shown below:
(1) Click DIFF Cuvette Immersion icon and a dialogue box will pop up as below;

(2) Click Yes and a prompt dialogue box will pop up;

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Services

(3) Proceed according to the prompts and a progress bar dialogue box will pop up as shown below. The cell
cleanser is being absorbed;

(4) The operation/status information bar will indicate that the instrument is immersing in the DIFF cuvette
after absorbing the cell cleanser. Please wait for a moment;
(5) The option to stop immersing will pop up. Click to stop immersion or wait for the instrument to finish
immersing automatically;

(6) The operation/status information bar will prompt that the DIFF cuvette immersion has successfully been
completed;

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Services

10.2.5.7 WBC cuvette immersion


Please refer to the methods of DIFF cuvette immersion to perform the operations of WBC cuvette immersion.
10.2.5.8 RBC cuvette immersion
Please refer to the methods of DIFF cuvette immersion to perform the operations of RBC cuvette immersion.

10.2.6 Whole machine maintenance


10.2.6.1 Fluidics initialization
If the main components have been replaced or the fluidics system of the analyser has been maintained, then
fluidics initialization should be performed.

Click in the interface, and click Whole Machine Maintenance tab in the pop-up interface to enter
the interface as shown below.

The steps for fluidics initialization are as shown below:


(1) Click Fluidics System Initialization and the operation/status information bar will indicate "Fluidics
System Initialization";
(2) The operation/status information bar will display "Fluidics System Initialization has Finished" upon
completion;
(3) You may continue to perform the operations of fluidics initialization according to the above steps if
necessary.

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Services

10.2.6.2 Clean fluidics


Clean fluidics should be performed if the background results of each parameter are beyond the normal
background.

Click in the interface, and click Whole Machine Maintenance tab in the pop-up interface to enter
the interface as shown below.

The steps for clean fluidics are as shown below:


(1) Click Clean Fluidics and the operation/status information bar will display "Clean Fluidics in Progress...";
(2) The operation/status information bar will prompt "Clean Fluidics has Finished" upon completion;
(3) You may continue to perform the operations of clean fluidics according to the above steps if necessary.
10.2.6.3 Fluidics system emptying
The analyser should perform the operations of fluidics system emptying before a short-distance transport
(transport time is less than 2 hours).

Click in the interface, and click Whole Machine Maintenance tab in the pop-up interface to enter
the interface as shown below.

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Services

The steps for fluidics system emptying are as shown below:


(1) Click Fluidics System Emptying and a dialogue box will pop up as shown below;

(2) Remove diluent and lyse tubes and place them in an empty beaker, then click OK to perform the
emptying operation;
(3) A dialogue box will be displayed as shown below when the emptying has been completed. Users should
turn off the power of the analyser as prompted in the interface;

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Services

Note:

1. This software can still be used after emptying has been completed.
2. When the dialogue box prompts to turn off the power of the instrument, the
analyser will restart if Restart is clicked.

10.2.6.4 Prepare to ship


The analyser should be prepared to ship if it will not be used for a long time (longer than 1 week) or before a
long-distance transport.

Click in the interface, and click Whole Machine Maintenance tab in the pop-up interface to enter
the interface as shown below.

The steps of preparing to ship are as shown below:


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Services

(1) Click Prepare to ship and a dialogue box will pop up as shown below;

(2) Remove diluent and lyse tubes and place them in an empty beaker, then click OK to perform the
emptying operation;
(3) The interface will continue to pop up the prompt dialogue box as shown below when the emptying has
been completed;

(4) Remove diluent and lyse tubes from the beaker and place them in a beaker filled with distilled water, then
click OK to perform priming;
(5) A prompt dialogue box will be displayed again as shown below when the prime has been completed;

(6) Remove diluent and lyse tubes from the beaker with distilled water and place them back in the original
empty beaker, then click OK to perform emptying again;

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Services

(7) A prompt dialogue box will pop up as shown below when the emptying has been completed. Users should
turn off the power of the instrument on the analyser end as prompted in the interface.

Note:

1. This software can still be used after preparing to ship has been completed.
2. When the dialogue box prompts to turn off the power of the instrument, the
analyser will restart if Restart is clicked.

10.2.7 Auto-cleaning
The analyser will perform auto-cleaning and prompt in the interface when sample counting has been
accumulated to 100 times.

Note:

1. When the conditions of auto-cleaning have been met but the analyser is
running or has failure, it will perform auto-cleaning again after the current
operation or troubleshooting has been completed.
2. All the counting cumulative values of auto-cleaning will be reset to "0"
automatically after auto-cleaning, probe cleanser soaking or powering off.
3. Scheduled auto-cleaning will be performed in self-testing and status
interfaces (for more than an hour).

10.2.8 Automatic reminder of cell cleanser immersion


(1) When the cumulative quantity of sample counting has reached 300 (default value) or more, the system
will prompt if immediate cell cleanser immersion is required to avoid pollutants from accumulating;

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Services

(2) Click Yes and a prompt dialogue box will pop up. Please place the cell cleanser under the probe and press
the counting button;

(3) After absorbing the solution for the first time as prompted, a progress bar dialogue box will pop up as
shown below and the absorption of cell cleanser will begin;

(4) The progress bar dialogue box will close automatically and a prompt dialogue box will pop up at the same
time;

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Services

(5) The operation/status information bar will indicate that the instrument is immersing in the cell cleanser
after absorbing the cell cleanser for the second time. Please wait for a moment;
(6) Click Stop Immersion or wait for the instrument to finish immersing automatically when immersion has
started;

(7) The immersion will continue for 15 minutes. The operation/status information bar will then prompt that
probe immersion has successfully been completed.

Note:

1. Cell cleanser immersion will not be prompted in self-testing and status


interfaces.
2. When the conditions of auto-prompt for probe cleanser soaking have been
met but the analyser is running or has failure, it will remind again after the
current operation or troubleshooting has been completed.
3. It will prompt again after performing sample counting for every 50 times
when the prompt information to execute cell cleanser immersion has popped up
but no immersion has been performed.
4. The counting cumulative values will be reset to "0" automatically after probe
cleanser soaking.
5. Cell cleanser immersion is an important part of normal operation of whole
machine maintenance, so it is not recommended to terminate immersion
halfway.

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Services

10.2.9 Timed sleep


The analyser will enter sleep automatically when the fluidics system has not been operating for 15 minutes
(default value).

The operation/status information bar will prompt after the analyser has entered sleep.

Note:

1. The waiting time to automatically enter sleep can be set. Please refer to
Chapter 5 Settings for details.
2. It will not enter sleep in self-testing and status interfaces.
3. When it is time for timed sleep, if the analyser is in failure status, then it will
determine whether to enter sleep after troubleshooting the failure.
4. Operations not related to the analyser, such as communications, printing, etc.,
will not be affected during timed sleep.

10.3 Status enquiry

Note:

If the status inspection value exceeds the normal range, then it will be highlighted
with red background.

10.3.1 Voltage and current


Click Menu in the interface, and select Services  Status in the pop-up menu.

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Services

Click Voltage and Current tab to enter the interface as shown below.

Users can check the voltage and current information of the instrument and also export or print the above
information.

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Services

10.3.2 Temperature and pressure


Click Menu in the interface, and select Services  Status in the pop-up menu.

Click Temperature and Pressure tab and a prompt dialogue box will pop up

The prompt dialogue box will be closed automatically and the interface will be displayed as shown below
after the fluidics sequence has been completed.

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Services

Users can check the temperature and pressure information and also export or print the above information.
A dialogue box as shown below will pop up and the analyser will perform pressure relief after the enquiry has
been completed and entered the interface other than the current temperature and pressure interface. The
analyser will not perform pressure relief when switching between the temperature and pressure interface and
failure management interface.

10.4 Version and configuration information


Click Menu in the interface and select Service  Version and Configuration Information in the menu.

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Services

Enter the interface as shown below.

Users can check the version and configuration information and also export or print the above information (not
supported temporarily).

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Services

10.5 Self-testing

10.5.1 Self-testing of syringe and sampling assemblies


Click Menu in the interface, and select Service  Self-Testing in the pop-up menu.

Click Syringe and Probe tab to enter the interface as shown below.

Users can test the performance of various syringes and probes.

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Services

10.5.2 Valve self-testing


Click Menu in the interface, and select Service  Self-testing in the pop-up menu.

Click Valve Self-testing tab to enter the following interface.

Users can test the status of a single valve and pump.


 A single valve self-testing
Judge whether this valve is normal according to if the valve can make a sound of opening and closing after
the number (such as "1") corresponding to the valve to test is clicked.

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Services

Note:

1. Valve self-testing is to judge whether this valve is normal according to if each


valve can make the sound of opening and closing.
2. The Status bar of the interface will display the current status of all valves
(On/Off). The valve will open first, and then close during testing.

10.5.3 Other self-testing


Click Menu in the interface, and select Service  Self-testing in the pop-up menu.

Click Other Self-testing tab to enter the following interface.

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Services

Users can test the status of each item above.


 Self-testing
Click an icon desired to test, the operation/status information bar will display the status of self-testing.
When self-testing is over, the interface of the test results dialogue box will pop up. Click OK and close the
prompt dialogue box.

Note:

You can try again several times after clicking OK if abnormal self-testing results
are prompted. And please contact our after-sales service department or your local
agent to resolve the issue if self-testing results are still abnormal.

You can continue to test other items according to the steps above if necessary.

10.6 Counter
Click Menu in the interface, and select Service  Counter in the pop-up menu.

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Services

Enter the interface as shown below.

Users can check the statistical information of above items and detailed statistical information of some of the
following items above.
 Check the detailed information
Users can check the detailed information related to the number of times that sample counting, QC and
calibration occurred.

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Click Detailed Information behind Times of Sample Counting. The interface displays the detailed
statistical results of the number of times of sample counting.

Click Detailed Information behind Times of QC. The interface displays the detailed statistical results of the
number of times of QC.

Click Detailed Information behind Times of Calibration. The interface displays the detailed statistical
results of the number of times of calibration.

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10.7 Log

Note:

1. System will automatically cover the oldest record if the log is full when
adding new records.
2. Logs not more than a year can be stored.
3. No more than 100 characters can be entered in the comment section.

10.7.1 Parameter modification


Click Menu in the interface, and select Service  Log in the pop-up menu.

Click Parameter Modification tab to enter the following interface.

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Users can check above log information, enter comment information and execute query operations.
 Comments
(1) Enter the comment information in Comment bar that corresponds to log records desired;
(2) Click Save on the lower part of the interface to save.
 Query
The operator can enter the query conditions on the lower part of the interface. Click Query, the Log
Information bar will display the information required.

10.7.2 Other Logs


Click Menu in the interface, and select Service  Log in the pop-up menu.

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Click Other Logs tab to enter the following interface.

Users can check above log information, enter comment information and execute query operations.
 Comments
(1) Enter the comment information in Comment bar that corresponds to log records desired;
(2) Click Save on the lower part of the interface to save.

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 Query
The operator can enter the query conditions on the lower part of the interface. Click Query, the Log
Information bar will display the information required.

10.7.3 Failure information

Note:

The failure information is visible only for administrators or people who have been
granted permission to view such information.

Click Menu in the interface, and select Service  Log in the pop-up menu.

Click Failure Information tab to enter the following interface.

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Users can check above log information, enter comment information and execute query operations.
 Comments
(1) Enter the comment information in Comment bar that corresponds to log records desired;
(2) Click Save on the lower part of the interface to save.
 Query
The operator can enter the query conditions on the lower part of the interface. Click Query, the Log
Information bar will display the information required.

10.7.4 All Logs

Note:

The total of all log information, which is visible for users of the current level, is
displayed in All Logs tab.

Click Menu in the interface, and select Service  Log in the pop-up menu.

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Click All Logs tab to enter the following interface.

Users can check above log information, enter comment information and execute query operations.
 Comments
(1) Enter the comment information in Comment bar that corresponds to log records desired;
(2) Click Save on the lower part of the interface to save.
 Query
The operator can enter the query conditions on the lower part of the interface. Click Query, the Log
Information bar will display the information required.

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Troubleshooting

Chapter 11. Troubleshooting

11.1 Overview
This chapter will introduce potential failure information to the analyser and will provide
corresponding processing methods.

Note:

These operation instructions do not belong to the maintenance manual and


only provide information about the measures that should be taken by the
operators when the analyser sounds a failure alarm or twinkles the status lamp.

11.2 Failure information and solutions


The software interface will automatically switch to the failure process interface and the analyser
will emit an alarm sound simultaneously if unusual conditions have been tested while using the
analyser.
The background colours used by the failure information area are, in order, red, orange, blue and
green according to failure levels from high to low.
Red:It represents a failure with a deadly level. The analyser will immediately put an end to
current activity and forbid any further activity after such failures.
Orange:It represents a failure level that ceases all activity. The analyser will immediately put an
end to current activity after such failures.
Blue:It represents a limited level failure. The analyser still can continue to execute current
operations but limit other operations related to such failures after such failures.
Green:It represents a prompted level failure. The analyser still can continue to execute current
operations and does not limit any other operations after such failures.
The failure process interface is as shown in the image below:

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Troubleshooting

The failure list provides the arisen failure name and failure help information. The failure name
will be displayed in the order of the failure occurs.
The operator can select it (highlighted) by clicking the failure name in the failure list. The help
information of the selected failure can be checked in the right side of the list of "Failure
Information" and "Help Information". The operator can perform failure procedures according to
the content of failure help.
The following functions are provided in current dialogue box:
 Failure elimination
Click One-key Failure Elimination, a dialogue box will be as shown below:

The software will eliminate any failures that can be automatically eliminated. For failures that
cannot be automatically eliminated, the operator can perform corresponding failure procedures
according to the failure help information.
 Mute
Clicking Mute will cease the alarm sound of the analyser.
The possible failure of the analyser and corresponding help information are as shown in the table
below:

11-44
Troubleshooting

Failure type Failure help information

Voltage exception 1. Please power off the analyser according to the normal
procedure first, and then restart it.

2. If the failure persists, please contact our company's after-sales


service department.

Driver board communication 1. Click Failure Elimination to automatically remove this


exception failure.

2. If the failure persists, please contact our company's after-sales


service department.

Sheath flow channel blockage 1. Click One-key Failure Elimination to automatically remove
this failure.

2. If the failure persists, please contact our company's after-sales


service department.

Syringe action exception 1. Click One-key Failure Elimination to automatically remove


this failure.

2. If the failure persists, please contact our company's after-sales


service department.

Probe action exception 1. Click One-key Failure Elimination to automatically remove


this failure.

2. If the failure persists, please contact our company's after-sales


service department.

Pressure exception 1. Click One-key Failure Elimination to automatically remove


this failure.

2. If the failure persists, please contact our company's after-sales


service department.

Vacuum exception 1. Click One-key Failure Elimination to automatically remove


this failure.

2. If the failure persists, please contact our company's after-sales


service department.

DIFF reaction tank 1. Click One-key Failure Elimination to automatically remove


temperature exception this failure.

2. If the failure persists, please contact our company's after-sales


service department.

Ambient temperature exceeds 1. Please ensure that the ambient temperature is in the normal
working temperature range range of [15, 30]℃.

11-45
Troubleshooting

2. Measuring results of the analyser may not be accurate if the


ambient temperature exceeds the normal range.

3. The failure will be automatically removed if the ambient


temperature is in the normal range.

4. If the failure persists, please contact our after-sales service


department.

Ambient temperature exceeds 1. Ambient temperature exceeds the allowable range of counting
running temperature range [10, 40] ℃.

2. Please ensure that the ambient temperature is in the normal


range of [15, 30]℃. The failure will be automatically removed.

3. If the failure persists, please contact our after-sales service


department.

Temperature exception of 1. Click One-key Failure Elimination to automatically remove


optical system this failure.

2. If the failure persists, please contact our company's after-sales


service department.

L-65LEO I lyse has expired 1. Please check if the L-65LEO I lyse is expired first. Please
replace with a barrel of new lyse if it is expired.

2. To replace the reagent, please refer to the solution in Chapter


10 Service - Maintenance of Replacing Reagent to enter the
dialogue box of reagent settings to handle the modification and
replacement of the reagent expiry date.

3. If L-65LEO I lyse is not expired, please enter the dialogue box


of reagent settings to check if the L-65LEO I lyse expiry date is
correct.

L-65LEO II lyse has expired 1. Please check if the L-65LEO II lyse is expired first. Please
replace with a barrel of new lyse if it is expired.

2. To replace reagent, please refer to the solution in Chapter 10


Service - Maintenance of Replacing Reagent to enter the dialogue
box of reagent settings to handle the modification and
replacement of reagent expiry date.

3. If the L-65LEO II lyse is not expired, please enter the dialogue


box of reagent settings to check if the L-65LEO II lyse expiry
date is correct.

The diluent has expired 1. Please check if the diluent is expired first. Please replace with a
barrel of new diluent if it is expired.

2. To replace reagent, please refer to the solution in Chapter 10

11-46
Troubleshooting

Service - Maintenance of Replacing Reagent to enter the dialogue


box of reagent settings to handle the modification and
replacement of reagent expiry date.

3. If diluent has not expired, please enter the dialogue box of


reagent settings to check if the diluent expiry date is correct.

L-65LH lyse has expired 1. Please check if the L-65LH lyse is expired first. Please replace
with a barrel of new lyse if it is expired.

2. To replace the reagent, please refer to the solution in Chapter


10 Service - Maintenance of Replacing Reagent to enter the
dialogue box of reagent settings to handle the modification and
replacement of the reagent expiry date.

3. If the L-65LH lyse is not expired, please enter the dialogue box
of reagent settings to check if the L-65LH lyse expiry date is
correct.

No diluent 1. Please check if there is any diluent in the diluent barrel first.

2. Please replace with a new barrel of diluent if there is no


diluent. Then click One-key Failure Elimination to start the
replacement and priming of diluent.

3. To replace the reagent, please refer to the solution in Chapter


10 Service - Maintenance of Replacing Reagent to enter the
dialogue box of reagent settings to handle the modification and
replacement of the reagent expiry date.

4. If there is a lot of diluent left or the failure persists after


replacing with new reagent, please contact our after-sales service
department.

No L-65D II lyse 1. Please check if there is any L-65LH lyse in the L-65LH lyse
barrel first.

2. Please replace with a new barrel of diluent if there is no


L-65LH lyse. Then click One-key Failure Elimination to start
the replacement and priming of L-65LH lyse.

3. To replace the reagent, please refer to the solution in Chapter


10 Service - Maintenance of Replacing Reagent to enter the
dialogue box of reagent settings to handle the modification and
replacement of the reagent expiry date.

4. If there is a lot of reagent left or the failure persists after


replacing with new reagent, please contact our after-sales service
department.

No L-65LEO I lyse 1. Please check if there is any L-65LEO I lyse in the L-65LEO I

11-47
Troubleshooting

lyse barrel first.

2. Please replace with a new barrel of diluent if there is no


L-65LEO I lyse. Then click One-key Failure Elimination to
start the replacement and priming of L-65LEO I lyse.

3. To replace the reagent, please refer to the solution in Chapter


10 Service - Maintenance of Replacing Reagent to enter the
dialogue box of reagent settings to handle the modification and
replacement of the reagent expiry date.

4. If there is a lot of reagent left or the failure persists after


replacing with new reagent, please contact our after-sales service
department.

No L-65LEO II lyse 1. Please check if there is any L-65LEO II lyse in the L-65LEO II
lyse barrel first.

2. Please replace a new barrel of diluent if there is no L-65LEO II


lyse. Then click One-key Failure Elimination to start the
replacement and priming of L-65LEO II lyse.

3. To replace the reagent, please refer to the solution in Chapter


10 Service - Maintenance of Replacing Reagent to enter the
dialogue box of reagent settings to handle the modification and
replacement of the reagent expiry date.

4. If there is a lot of reagent left or the failure persists after


replacing with new reagent, please contact our after-sales service
department.

Waste are full 1. Please empty the waste barrel or replace with a new waste
barrel.

2. If the failure persists, please contact our company's after-sales


service department.

The right door of the analyser 1. Please close the right door of the analyser.
is open
2. Click One-key Failure Elimination to automatically remove
this failure.

3. If the failure persists, please contact our after-sales service


department.

Optical component cover is 1. Please close the laser component cover.


open
2. If the failure persists, please contact our company's after-sales
service department.

Background exception 1. Please check if the diluent is polluted first.


(WBC/ RBC /PLT)
2. Please click One-key Failure Elimination to remove this
11-48
Troubleshooting

failure if it is not polluted.

3. If the failure persists, please contact our after-sales service


department.

WBC plug hole 1. Please click One-key Failure Elimination to automatically


remove this failure.

2. If this failure occurs frequently, please refer to the solution in


Chapter 10 Service - Maintenance of Operation Manual to
execute the operation of immersing the WBC channel probe in
solution.

3. If the failure persists, please contact our after-sales service


department.

WBC bubbles 1. Please check if the joint connection of reagent catheters is


loose first.

2. Please click One-key Failure Elimination to remove this


failure if it is not loose.

3. If the failure persists, please contact our after-sales service


department.

RBC plug hole 1. Please click One-key Failure Elimination to automatically


remove this failure.

2. If this failure occurs frequently, please refer to the solution in


Chapter 10 Service - Maintenance of Operation Manual to
execute the operation of immersing the RBC channel probe in
solution.

3. If the failure persists, please contact our after-sales service


department.

RBC bubbles 1. Please check if the joint connection of reagent catheters is


loose first.

2. Please click One-key Failure Elimination to remove this


failure if it is not loose.

3. If the failure persists, please contact our after-sales service


department.

HGB testing exception 1. Please refer to the solution in Chapter 5 Settings - Gain
Settings in Operation Manual to enter the dialogue box of Gain
Settings to adjust HGB background voltage to 4.3 - 4.7 V.
Adjustment to about 4.5V is recommended.

2. If the failure persists, please contact our company's after-sales


service department.

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Troubleshooting

Voltage exception for HGB 1. Please refer to the solution in Chapter 5 Settings - Gain
background Settings in Operation Manual to enter the dialogue box of Gain
Settings to adjust HGB background voltage to 4.3 - 4.7 V.
Adjustment to about 4.5V is recommended.

2. If the failure persists, please contact our company's after-sales


service department.

The background for DIFF 1、 Please check if L-65LEO I or L-65LEO II is polluted first.
scattergram exception
2. Please click One-key Failure Elimination to remove this
failure if it is not polluted.

3. If the failure persists, please contact our after-sales service


department.

Voltage exception of pinhole 1. Please click One-key Failure Elimination to automatically


remove this failure.

2. If the failure persists, please contact our company's after-sales


service department.

Appendix A Specification
A.1 Product classification
LW D6500 Classified according to China medical apparatus and instruments management:
It belongs to the blood analysis system among the clinical laboratory analytical instruments
(6840). Its management category is II.

A.2 Supplementary reagents of products


Diluent L-65D diluent
L-65LEO I Lyse
Lyse L-65LEO II Lyse
L-65LH Lyse
Medical cleaning fluid L-65 probe cleaning Lyse

A.3 Parameter specification


Name Abbreviations Default unit
WBCs number WBC 109 / L
Neutrophils number Neu# 109 / L
Lymphocytes number Lym# 109 / L
Monocytes number Mon# 109 / L
Eosinophils number Eos# 109 / L
Basophils number Bas# 109 / L

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ALY# (research
Abnormal lymphocytes number parameters) 109 / L
Large immature cells number LIC# (research 109 / L
Neutrophils percentage parameters)
Neu% %
Lymphocytes percentage Lym% %
Monocytes percentage Mon% %
Eosinophils percentage Eos% %

Basophils percentage Bas% %


Abnormal lymphocytes ALY% (research
percentage parameters) %
LIC% (research
Large immature cells percentage parameters) %
Red blood cell number RBC 1012/ L
Haemoglobin HGB g/L
Haematocrit HCT %
Mean corpuscular volume MCV fL

Mean corpuscular haemoglobin MCH pg


Mean corpuscular haemoglobin
concentration MCHC g/L
Red blood cell distribution width
standard deviation RDW-SD fL
Red blood cell distribution width
coefficient of variation RDW-CV %
Platelets number PLT 109 / L
Mean platelet volume MPV fL

Platelet distribution width PDW Nil


Plateletcrit PCT %
Platelet-large cell ratio P-LCR %
Red blood cell histogram RBC Histogram Nil
Platelet histogram PLT Histogram Nil
Distribution diagram of WBC/BASO
leucocytes/basophils Histogram Nil
Histogram
White diagram
blood cell histogram WBC Histogram Nil
Diff Scattergram Diff Scattergram Nil

A.4 Sampling characteristic


A.4.1 Sample size for each analysis
Whole blood mode ≤16 μL

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Troubleshooting

Prediluted mode ≤20 μL

A.4.2 Throughput
Whole blood mode ≥60 Tests/h

Prediluted mode ≥50 Tests/h

A.5 Performance specifications

A.5.1 Display ranges of main parameters

Parameters Display ranges


WBC 0 - 200.0×109/L
RBC 0 - 18.00×1012/L
HGB 0 - 300g/L
PLT 0 - 2000×109/L
HCT 0% - 80%

A.5.2 Normal background


Parameters Normal background
WBC ≤ 0.3  109 / L.
RBC ≤ 0.03 1012/ L.
HGB ≤1 g / L
HCT ≤0.5 %
PLT ≤ 10 109/ L.

A.5.3 Linearity ranges

Measuring Linearity Linear tolerances (whole Linear tolerances


items measuring ranges blood mode) (pre-dilution mode)
WBC 0.00 - 150.00×109/L ±0.30×109/L or ±5% ±0.60×109/L or ±6%
RBC 0.00 - 8.50×1012/L ±0.05×1012/L or ±5% ±0.10×1012/L or ±10%
HGB 0 - 250g/L ±2g/L or ±2% ±4g/L or ±3%
PLT 0 - 1000×109/L ±10×109/L or ±8% ±20×109/L or ±16%
(RBC≤7.0)

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Troubleshooting

HCT 0 - 67% ±2% (HCT value) or ±3% ±4% (HCT value) or ±6%
(error percentage) (error percentage)

A.5.4 Reproducibility
Measure the blood sample that satisfies the requirements 11 times continuously with the analyser.
Take the results from 2 to 11 times to determine repeatability.

Parameters Ranges Repeatability of Repeatability of


whole blood sample pre-dilution sample
(CV/absolute (CV/absolute
deviation d※) deviation d※)
WBC (4.0 - 15.0)×109/L ≤2.0% ≤4.0%
50.0% - 60.0% ±4.0 (absolute ±8.0 (absolute
Neu% deviation) deviation)
25.0% - 35.0% ±3.0 (absolute ±6.0 (absolute
Lym% deviation) deviation)
5.0% - 10.0% ±2.0 (absolute ±4.0 (absolute
Mon% deviation) deviation)
2.0% - 5.0% ±1.5 (absolute ±2.5 (absolute
Eos% deviation) deviation)
0.5% - 1.5% ±0.8 (absolute ±1.2 (absolute
Bas% deviation) deviation)
RBC (3.50 - 6.00)×1012/L ≤1.5% ≤3.0%
HGB (110 - 180) g/L ≤1.5% ≤3.0%
MCV (70 - 120) fL ≤1.0% ≤2.0%
PLT (150 - 500)×109/L ≤4.0% ≤8.0%
MPV / ≤4.0% ≤8.0%
※:Absolute deviation d = measured value - measured average value

A.5.5 Carryover
Parameters Carryover
WBC ≤0.5 %
RBC ≤0.5 %
HGB ≤0.5 %
HCT ≤0.5 %
PLT ≤1.0 %

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Troubleshooting

A.6 Input and output devices

Warnings:
External devices like computer, printer, etc must pass the mandatory
certification of CCC (S&E). Using external devices that do not satisfy the
requirements may cause abnormal running of the system and personal injury.

Note:
1. The external computer must satisfy the configuration requirements in A.6.1.
2. The external computer should be configured to double network cards if the
analyser needs to communicate with laboratory information system.

A.6.1 External computer (optional)


PC (IBM compatible computer)
Memory:2G or above
HDD space:4G or above
Operating system: XP Home/XP Professional + SP3/ win 7
CPU:Dual-core of 1.6G above

A.6.2 Keyboard (optional)


Standard 101 keyboard

A.6.3 Mouse (optional)

A.6.4 External barcode scanner (optional)

A.6.5 Printer (optional)

A.7 Analyser interface


One port.

A.8 Power supply


Voltage Input power Frequency

11-54
Troubleshooting

Analyser A.C 100V - 240V ≤200 VA 50/60 Hz

A.9 Electro magnetic compatibility


This product follows the requirements concerning emission and anti-interference according to
the standards of EN 61326-1:2006 and EN 61326-2-6:2006.

A.10 Sound pressure


Maximum sound pressure:66.2dBA

Note:
Please store and use the analyser only in the specified environmental
conditions.

A.11 Working environment


 Ambient temperature range:15 ℃ - 30 ℃
 Relative ambient humidity range:10% - 90 %
 Atmospheric pressure range:70 kPa - 110 kPa

A.12 Storage environment


 Ambient temperature range:-10 ℃ - 40 ℃
 Relative humidity range:10 % - 90 %
 Atmospheric pressure range:50 kPa - 110 kPa

A.13 Operating environment


 Ambient temperature range:10 ℃ - 40 ℃
 Relative humidity range:10 % - 90 %
 Atmospheric pressure range:70 kPa - 110kPa

11-55
Troubleshooting

A.14 Overall dimensions and weight

Heig
ht
De
pth
Widt
h
Analyser of analyser
Width ≤410
(mm)
Height ≤550
(mm)
Depth ≤550
(mm)
Weight ≤42
(Kg)

11-56
Troubleshooting

Appendix B Names and Contents of Toxic


and Hazardous Substances or Elements
Names of Components Toxic and hazardous substances or elements
Hexavale Polybro
Polybro
nt minated
Lead Mercur Cadmiu minated
Chromiu diphenyl
(Pb) y (Hg) m (Cd) biphenyl
m ethers
s (PBB)
(Cr(VI)) (PBDE)
Analyser Analyser
〇 〇 〇 〇 〇 〇
casing
PCBA of
×(1) 〇 〇 〇 〇 〇
analyser
Sheet metal
parts of 〇 〇 〇 ×(2) 〇 〇
analyser
Machine
parts of 〇 〇 〇 〇 〇 〇
analyser
Plastic parts
〇 〇 〇 〇 〇 〇
of analyser
Ceramic
parts of 〇 〇 〇 〇 〇 〇
analyser
Hardware
parts of 〇 〇 〇 〇 〇 〇
analyser
Connection
cables of 〇 〇 〇 〇 〇 〇
analyser
Fluidics
system 〇 〇 〇 〇 〇 〇
components

11-57
of analyser
Accessories Label
identificatio 〇 〇 〇 〇 〇 〇
n
Bottle cap
〇 〇 〇 〇 〇 〇
components
Maintenanc
〇 〇 〇 〇 〇 〇
e tools
Wash block 〇 〇 〇 〇 〇 〇
Packaging Packaging
〇 〇 〇 〇 〇 〇
materials

〇: indicates that the toxic or hazardous substances contained in all homogeneous materials of this
component are below the tolerated requirements of SJ/T 11363-2006.
×: indicates that the toxic or hazardous substances contained in at least one of the homogeneous
materials of this component are above the tolerated requirements of SJ/T 11363-2006.
(1) Some parts on the circuit boards contain lead as leaded solder is used during the machining
process.
(2) Hexavalent chromium is used in the machining process of the surface-coating of sheet metal
parts.

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