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The user manual is applicable to Automatic Hematology Analyzer (model: BF-6900/ BF-6960) and all figures
concerned are described based on the Automatic Hematology Analyzer (model: BF-6960, hereinafter
referred to as the Analyzer).

DESCRIPTION

Dear users, thanks for buying the Automatic Hematology Analyzer (model: BF-6900/ BF-6960).

Please read the manual carefully before operation as incorrect operation may affect the test results of the Analyzer or
cause personal injury.

After reading, please reserve the manual properly for reference at any time.

Manufacturer: DIRUI INDUSTRIAL CO., LTD.

Manufacturer Address:

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95 Yunhe Street, New & High Tech. Development Zone, Changchun, Jilin 130012, the People’s Republic of China

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Production Address:
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3333 Yiju Road, New & High Tech. Development Zone Changchun, Jilin 130103, the People’s Republic of China
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Place of Production: Changchun, China


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Tel.: 400 811 6695 400 811 6605


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Website: http://www.dirui.com.cn
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E-mail: dirui@dirui.com.cn
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Complaints Hotline: 0431-81935326 85177245


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Fax: 0431-85173354
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Date of Production: See the label.

Service Life: 7 years

Date of Compilation/ Revision: 04-2020.


CAUTION

● The Analyzer shall be used by professional medical examination personnel or trained doctors, nurses or testers.

● As the Analyzer has biological and chemical risks, the operator shall be trained and use personal protective
appliance to reduce the risk.

● Only trained operators are allowed to conduct dangerous operations, such as moving parts.

● The hospital or inspection institution shall prepare a service plan and carry out servicing and maintenance in strict
accordance with the service plan, or the Analyzer may have faults.

● The Analyzer shall be controlled with a special software designated by the company. Installation of other software
or hardware on the computer may affect the normal operation of the Analyzer. Please do not operate other software

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during the operation of the Analyzer.

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● Please refer to the instructions of reagent for the use and storage of the reagent and ensure the reagent is used

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within the life of the reagent shown in the instructions.
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● Do not use reagent beyond its life. After its seal is damaged, prevent dust, dirty matters or bacteria entering it.
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● Do not use any organic solvents such as turpentine and benzene to rinse the outer part of the Analyzer as it may
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cause the color or shape changes of the Analyzer. Use soft or wet cloth to clean the Analyzer and use diluted
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detergent or ethanol to remove severe stains.


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● Under an environment with low transportation or storage temperature or relative humidity greater than 70%, the
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Analyzer shall be turned on for testing only after it is stored in a normal working environment for 24 hours.

● The Analyzer shall be provided with an independent power source. If it shares one power socket with other
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electrical equipment, the electromagnetic interference may affect the test results of the Analyzer.
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● Do not pull or insert the plug with wet hands as it may cause electric shock.

● Damaged power cable and connection cable shall not be used. The power cables and wires shall not be trodden,
twisted or pulled as it may cause a fire.

● The Analyzer can only be used under a good grounded condition.

● The input voltage shall meet the requirements of the Analyzer and the fuse of specified specification shall be used.

● Ensure the switch of the Analyzer is at the [O] position before connecting the power cable.

● The Analyzer shall not be used in a flammable and explosive environment.

● Do not touch the moving components when the Analyzer is operating to prevent accidents.

● When the power for the Analyzer is connected, servicing personnel not authorized shall not open the left and right
doors and upper cover.

● Please use the Analyzer under conditions regulated in the manual. If not, the Analyzer may not operate normally,
the test results may not be reliable, the components of the Analyzer may be damaged and personal injuries may be
caused.

● The protection measures provided for the Analyzer may become invalid if the Analyzer is not used according to
the manual.

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WARNING

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● The operator is obligated to follow national and local regulations on discharge and treatment of expired reagent,
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waste liquid, waste sample and consumables.


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● The waste liquid and the consumables shall be correctly treated. As the blood in the waste liquid may be polluted
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by pathogen, please treat the waste liquid and the consumables of the Analyzer according to regulations about
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medical waste, infectious waste and industrial waste.


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● Do not touch the sampling probe as the blood sample, quality control object and calibration object on the sampling
probe have potential biological infectivity. During the sample aspirating process of the sampling probe, prevent
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touching the test tube wall and probe tip as it may cause bleeding. Besides, a certain distance shall be kept from the
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aspiration probe tip to the bottom of container, or the accuracy of the aspirated liquid volume may be affected.
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● Do not touch the blood sample of patients directly.

● Disposable articles shall not be used repeatedly.


DECLARATION

Dirui Company has the final interpretation right of the manual.

Dirui Company declares that it will be responsible for the safety, reliability and performances of the Analyzer only
if all following requirements are met.

(1)The installation, commissioning and servicing of the Analyzer are undertaken by professional personnel of Dirui
Company.

(2)Relevant electrical equipment complies with national standards.

(3)The Analyzer is operated according to the manual.

No further notice will be provided in case of any changes to the software interface.

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User Manual

Contents

Chapter 1 Brief introduction .........................................................................................................1-1 


1.1 Overview .......................................................................................................................................................... 1-1 
1.2 Normal operating conditions ......................................................................................................................... 1-1 
1.3 Analyzer parameters ...................................................................................................................................... 1-1 
1.4 Working principle........................................................................................................................................... 1-2 
1.4.1 Sample aspirating .............................................................................................................................................................. 1-2 
1.4.2 Sample dilution ................................................................................................................................................................. 1-2 
1.4.3 White blood cell measurement .......................................................................................................................................... 1-5 
1.4.4 Hemoglobin concentration measurement - colorimetric method ....................................................................................... 1-7 
1.4.5 Red blood cell/ platelet measurement ................................................................................................................................ 1-7 
1.4.6 Rinsing .............................................................................................................................................................................. 1-9 
1.5 Structure of the instrument ........................................................................................................................... 1-9 

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1.5.1 Front view of the Analyzer .............................................................................................................................................. 1-10 

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1.5.2 Rear view of the Analyzer ............................................................................................................................................... 1-10 
1.5.3 Left view of the Analyzer ................................................................................................................................................ 1-11 

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1.6 External device of the Analyzer................................................................................................................... 1-11 
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1.7 Symbol ........................................................................................................................................................... 1-11 
1.8 Identification ................................................................................................................................................. 1-13 
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Chapter 2 Installation .....................................................................................................................2-1 


2.1 Installation requirements ............................................................................................................................... 2-1 
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2.1.1 Space requirements............................................................................................................................................................ 2-1 


2.1.2 Power requirements ........................................................................................................................................................... 2-1 
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2.1.3 Environmental requirements.............................................................................................................................................. 2-1 


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2.2 Unpacking........................................................................................................................................................ 2-2 


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2.2.1 Unpacking steps ................................................................................................................................................................ 2-2 


2.2.2 Handling method ............................................................................................................................................................... 2-2 
2.2.3 Instrument internal fixing devices removal instructions .................................................................................................... 2-2 
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2.3 Instrument installation ................................................................................................................................... 2-4 


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2.4 Turn-on and user login................................................................................................................................... 2-6 


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2.4.1 User login .......................................................................................................................................................................... 2-6 


2.4.2 Description of counting interface ...................................................................................................................................... 2-8 
2.5 Gas & liquid path diagrams......................................................................................................................... 2-10 
Chapter 3 Setting of the Analyzer .................................................................................................3-1 
3.1 Overview .......................................................................................................................................................... 3-1 
3.2 Mode setting .................................................................................................................................................... 3-1 
3.3 Unit settings ..................................................................................................................................................... 3-2 
3.4 Reference values setting ................................................................................................................................. 3-3 
3.5 Abnormity flags setting .................................................................................................................................. 3-4 
3.6 QC setting ........................................................................................................................................................ 3-6 
3.6.1 QC method ........................................................................................................................................................................ 3-6 
3.6.2 L-J setting .......................................................................................................................................................................... 3-7 
3.6.3 Xbar setting ....................................................................................................................................................................... 3-8 
3.6.4 X-B setting ........................................................................................................................................................................ 3-8 

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3.7 Information setting ......................................................................................................................................... 3-9 


3.8 User settings .................................................................................................................................................. 3-13 
3.9 Instrument setting......................................................................................................................................... 3-16 
3.9.1 Sleep setting .................................................................................................................................................................... 3-16 
3.9.2 Automatic rinsing setting ................................................................................................................................................ 3-16 
3.9.3 Blocked hole setting ........................................................................................................................................................ 3-17 
3.9.4 Other................................................................................................................................................................................ 3-18 
3.10 Software setting........................................................................................................................................... 3-18 
3.10.1 Date format setting ........................................................................................................................................................ 3-18 
3.10.2 Print settings .................................................................................................................................................................. 3-19 
3.10.3 Network settings ............................................................................................................................................................ 3-20 
3.10.4 Language settings .......................................................................................................................................................... 3-21 
3.10.5 Other setting .................................................................................................................................................................. 3-22 
Chapter 4 Calibration.....................................................................................................................4-1 
4.1 Overview .......................................................................................................................................................... 4-1 

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4.2 Calibration frequency .................................................................................................................................... 4-1 

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4.3 Calibration method......................................................................................................................................... 4-1 
4.4 Calibrator calibration .................................................................................................................................... 4-1 

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4.4.1 Input of calibrator reference value..................................................................................................................................... 4-2 
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4.4.2 Calibration counting .......................................................................................................................................................... 4-2 
4.4.3 Save calibration coefficient ............................................................................................................................................... 4-3 
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4.5 Fresh blood calibration .................................................................................................................................. 4-5 


4.5.1 Preparation of fresh blood ................................................................................................................................................. 4-5 
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4.5.2 Calibration count ............................................................................................................................................................... 4-5 


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4.5.3 Save calibration coefficient ............................................................................................................................................... 4-6 


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4.6 Manual calibration ......................................................................................................................................... 4-7 


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4.7 Calibration history ......................................................................................................................................... 4-8 


Chapter 5 QC ..................................................................................................................................5-1 
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5.1 Overview .......................................................................................................................................................... 5-1 


5.2 L-J QC ............................................................................................................................................................. 5-1 
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5.2.1 Setting ............................................................................................................................................................................... 5-2 


5.2.2 QC count ........................................................................................................................................................................... 5-3 
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5.2.3 QC diagram ....................................................................................................................................................................... 5-4 


5.2.4 QC list ............................................................................................................................................................................... 5-6 
5.3 Xbar QC .......................................................................................................................................................... 5-8 
5.4 X-B QC ............................................................................................................................................................ 5-8 
5.4.1 Setting ............................................................................................................................................................................... 5-8 
5.4.2 QC diagram ....................................................................................................................................................................... 5-9 
5.4.3 QC list ............................................................................................................................................................................. 5-10 
5.5 Xbar-R QC .................................................................................................................................................... 5-11 
5.5.1 Setting ............................................................................................................................................................................. 5-11 
5.5.2 QC count ......................................................................................................................................................................... 5-12 
5.5.3 QC diagram ..................................................................................................................................................................... 5-14 
5.5.4 QC list ............................................................................................................................................................................. 5-16 
Chapter 6 Sample registration .......................................................................................................6-1 
6.1 Overview .......................................................................................................................................................... 6-1 
6.2 Edit information ............................................................................................................................................. 6-1 

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6.2.1 Sample information ........................................................................................................................................................... 6-2 


6.2.2 Patient information ............................................................................................................................................................ 6-2 
6.3 Download work list ......................................................................................................................................... 6-3 
6.4 Delete work list................................................................................................................................................ 6-4 
Chapter 7 Routine operation .........................................................................................................7-1 
7.1 Overview .......................................................................................................................................................... 7-1 
7.2 Preparation for operation .............................................................................................................................. 7-1 
7.3 Turn-on ............................................................................................................................................................ 7-2 
7.4 Daily QC .......................................................................................................................................................... 7-2 
7.5 Sample preparation ........................................................................................................................................ 7-2 
7.5.1 Test tube types................................................................................................................................................................... 7-2 
7.5.2 Whole-blood sample.......................................................................................................................................................... 7-3 
7.5.3 Peripheral blood sample .................................................................................................................................................... 7-3 
7.6 Whole-blood sample analysis ......................................................................................................................... 7-5 
7.6.1 Sample analysis steps ........................................................................................................................................................ 7-5 

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7.6.2 View diagram .................................................................................................................................................................... 7-6 

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7.6.3 View of research parameters ............................................................................................................................................. 7-7 
7.7 Analysis of pre-dilution samples.................................................................................................................... 7-8 

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7.8 Sample analysis under automatic whole-blood mode .................................................................................. 7-9 
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7.8.1 Bar code and pasting requirements .................................................................................................................................... 7-9 
7.8.2 Change of mode ................................................................................................................................................................ 7-9 
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7.8.3 Sample analysis steps ...................................................................................................................................................... 7-10 
7.9 Analysis of emergency samples.................................................................................................................... 7-11 
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7.10 Parameter alarm ......................................................................................................................................... 7-13 


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7.10.1 Parameter alarm type ..................................................................................................................................................... 7-13 


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7.10.2 Abnormal alarm for classification or morphology ......................................................................................................... 7-13 


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7.11 Sleep ............................................................................................................................................................. 7-15 


7.12 Rinsing and unblocking.............................................................................................................................. 7-15 
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7.13 Turn-off ....................................................................................................................................................... 7-15 


Chapter 8 History query ................................................................................................................8-1 
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8.1 Overview .......................................................................................................................................................... 8-1 


8.2 Selection of record .......................................................................................................................................... 8-1 
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8.3 Query ............................................................................................................................................................... 8-2 


8.4 Audit and cancel audit.................................................................................................................................... 8-2 
8.5 LIS transmission ............................................................................................................................................. 8-2 
8.6 Delete ............................................................................................................................................................... 8-2 
8.7 Image review ................................................................................................................................................... 8-3 
8.7.1 Edit information ................................................................................................................................................................ 8-3 
8.7.2 Edit results ......................................................................................................................................................................... 8-4 
8.7.3 Histogram adjustment........................................................................................................................................................ 8-5 
Chapter 9 System maintenance .....................................................................................................9-1 
9.1 Overview .......................................................................................................................................................... 9-1 
9.2 Maintenance guide .......................................................................................................................................... 9-1 
9.2.1 Regular maintenance ......................................................................................................................................................... 9-1 
9.2.2 Timely maintenance .......................................................................................................................................................... 9-2 
9.3 Maintenance .................................................................................................................................................... 9-2 

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9.3.1 Basic status ........................................................................................................................................................................ 9-2 


9.3.2 System version .................................................................................................................................................................. 9-2 
9.3.3 Service ............................................................................................................................................................................... 9-3 
9.3.4 HGB verification ............................................................................................................................................................... 9-9 
9.3.5 Mechanical detection ......................................................................................................................................................... 9-9 
9.3.6 Data backup ..................................................................................................................................................................... 9-12 
9.3.7 Counter ............................................................................................................................................................................ 9-13 
9.4 Replacement of vulnerable parts ................................................................................................................. 9-13 
9.4.1 Replacement of sampling probe ...................................................................................................................................... 9-13 
9.5 Maintenance of the instrument before stopping using .............................................................................. 9-14 
9.6 Rinsing and maintenance of the instrument............................................................................................... 9-14 
9.7 Disposal of waste liquid ................................................................................................................................ 9-15 
9.8 Disposal of discarded instrument ................................................................................................................ 9-15 
Chapter 10 System log ..................................................................................................................10-1 
10.1 System log .................................................................................................................................................... 10-1 
Chapter 11 Reagent management ............................................................................................... 11-1 

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11.1 Reagent registration ................................................................................................................................... 11-1 
11.2 Reagent setting ............................................................................................................................................ 11-3 

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Chapter 12 Alarm information and handling ............................................................................12-1 
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12.1 Overview ...................................................................................................................................................... 12-1 
12.2 Alarm information and troubleshooting................................................................................................... 12-2 
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Chapter 13 Transportation and storage .....................................................................................13-1 


13.1 Transportation ............................................................................................................................................ 13-1 
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13.2 Storage ......................................................................................................................................................... 13-1 


Appendix A Letter of guarantee ................................................................................................... A-1 
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Appendix B Network communication interface protocol V1.7 .................................................. B-1 


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Appendix C Product description .................................................................................................. C-1 


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Appendix D Performance indexes ................................................................................................ D-1 


Appendix E Parts list ..................................................................................................................... E-1 
Appendix F Statement on electromagnetic compatibility .......................................................... F-1 
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IV
User Manual

Chapter 1 Brief introduction

1.1 Overview
The Automatic Hematology Analyzer (model: BF-6900/ BF-6960) is designed and produced based on the idea of
accurate measurement, simple operation and low material consumption, conforming to users' requirements. The
Analyzer can provide quantitative analysis results of 25 parameters.
Applicable scope of the Analyzer: It can count the number of red blood cells and platelets in blood sample with
impedance method, test the hemoglobin concentration with colorimetric method, get the total number and have
five-classification of the white blood cells with semiconductor laser flow cytometry and calculate hemocyte related
parameters.
Contraindications: None.

1.2 Normal operating conditions


(1)Supply voltage: 100-240V~, 50/60Hz.
(2)Ambient temperature: 10℃~30℃.

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(3)Relative humidity: Not exceeding 70%.

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(4)Atmospheric pressure: 75kPa~106kPa.

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(5)Altitude: Not greater than 2000m.
(6)No frost, condensation, water seepage, rain or solar exposure. CO
1.3 Analyzer parameters
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Model
Indicators
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BF-6900 BF-6960
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WBC, BAS#, NEU#, EOS#, LYM#, WBC, BAS#, NEU#, EOS#, LYM#, MON#,
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MON#, BAS%, NEU%, EOS%, LYM%, BAS%, NEU%, EOS%, LYM%, MON%,
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Test items MON%, RBC, HGB, MCV, MCH, RBC, HGB, MCV, MCH, MCHC,
MCHC, RDW-CV, RDW-SD, HCT, RDW-CV, RDW-SD, HCT, PLT, MPV,
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PLT, MPV, PDW, PCT, P-LCR, P-LCC, PDW, PCT, P-LCR, P-LCC,

Five-classification of white blood cell, Five-classification of white blood cell, test


test of 25 parameters, 2 scattergrams and of 25 parameters, 4 scattergrams and 3
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Parameters 2 histograms, prompt and alarm functions histograms, prompt and alarm functions in
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Basic in case of pathological and morphological case of pathological and morphological


characteristics abnormalities. abnormalities.
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Test speed 60 samples/ hour 60 samples/ hour

Sample feeding Manual or automatic feeding (sample Manual or automatic feeding (sample feeder
way feeder is optional) is optional)
Sample storage
At least 200000 At least 500000
volume
Sample bar code Automatic recognition or manual input Automatic recognition or manual input

4 types, including 1 type of diluent and 3 4 types, including 1 type of diluent and 3
Reagent type
types of lyse types of lyse

Measurement of Hemoglobin measurement with Hemoglobin measurement with


Reagent hemoglobin cyanogen-free compound cyanogen-free compound
system
It alarms when there is no reagent or the It alarms when there is no reagent or the
Reagent alarm
reagent is expired. reagent is expired.
Bar code of An external bar code reader or input An external bar code reader or input
reagent manually manually

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Model
Indicators
BF-6900 BF-6960

White blood cell


classification Optical analysis method Optical analysis method
Analysis principle
system Optical analysis method for WBC; Optical analysis method for WBC;
Counting
Impedance method for RBC and PLT; Impedance method for RBC and PLT;
method
Colorimetric method for HGB Colorimetric method for HGB
Interface RJ45 network interface, USB interface RJ45 network interface, USB interface
Data
system Connection with
Supported Supported
LIS/HIS system

With sample feeder: 48kg; With sample feeder: 48kg;


Weight
Without sample feeder: 40kg; Without sample feeder: 40kg;

With sample feeder: With sample feeder:


531mm×556mm×679mm 531mm×556mm×679mm
Whole
(H×W×L); (H×W×L);
machine Dimensions

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Without sample feeder: Without sample feeder:
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531mm×380mm×520mm 531mm×380mm×520mm
(H×W×L) (H×W×L)

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Power
240VA 240VA
consumption
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1.4 Working principle
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The Analyzer applies the electrical impedance method to test the number and volume distribution of red blood cell
and platelet. Colorimetric method is used to measure the concentration of hemoglobin. Semiconductor laser flow
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cytometry is used to obtain the total number of white blood cells and count the white blood cell of five
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classifications. On this basis, it calculates the results of other parameters.


1.4.1 Sample aspirating
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With different configuration, the instrument provides two sample feeding ways, closed sample feeding and
automatic sample feeding. The closed sample feeding supports whole blood mode, micro-whole blood mode and
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pre-dilution mode, while the automatic sample feeding supports whole blood mode.
The instrument supports the whole blood, micro-whole blood and pre-dilution modes. Under whole blood mode or
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micro-whole blood mode, the Analyzer will aspirate 25μL (CBC+DIFF mode) or 20μL (CBC mode) whole blood
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sample.
Under pre-dilution test mode, the operator shall mix the 20μL peripheral blood sample with 180μL dilute outside the
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Analyzer to form a diluted sample (dilution ratio: 1:10), and then send the diluted sample to the Analyzer for
sampling. And then, the Analyzer will aspirate 80μL (CBC+DIFF mode) or 65μL (CBC mode) diluted sample.
1.4.2 Sample dilution
After the sample to be tested is collected with a sampling probe, it will then be dispensed to WBC classification
detector and RBC count cell according to test demands. And then, in parallel dilution processes, test sample used for
WBC classification measurement, WBC count/ hemoglobin measurement, red blood cell/ platelet measurement are
respectively formed with the action of different reagents.
For different test samples, the Analyzer provides three test modes, whole blood test mode, micro whole blood mode
and pre-dilution (peripheral blood) test mode.
1.4.2.1 Whole-blood mode
(1)Red blood cell/ platelet dilution process

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Whole-blood sample
6μL

Dispense BF-5D
diluent 2500μL

Pre-dilution
Aspirate sample 45μL
Dilution ratio1:417.65

Dispense BF-5D diluent


to RBC cell 2700μL

Dilute in RBC cell


Dilution ratio 1:25060

Fig. 1-4-1 Red blood cell/ platelet dilution process


(2)White blood cell/ hemoglobin dilution process

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Fig. 1-4-2 White blood cell/ hemoglobin dilution process


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(3)White blood cell classification dilution process


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Fig. 1-4-3 White blood cell classification dilution process


1.4.2.2 Pre-dilution mode
(1)Red blood cell/ platelet dilution process

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Whole-blood sample
20μL

BF-5D diluent 180μL

Dilution ratio is 1:10

Take 25μL sample


BF-5D diluent 2.0mL
after mixing

Dilution ratio is 1:810

Take 70μL sample


BF-5D diluent 2.5mL
after mixing

Red blood cell/ platelet test

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sample with dilution ratio of

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about 1:28928

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Fig. 1-4-4 Red blood cell/ platelet dilution process
(2)White blood cell/ hemoglobin dilution process CO
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Fig. 1-4-5 White blood cell/ hemoglobin dilution process


(3)White blood cell classification dilution process

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Fig. 1-4-6 White blood cell classification dilution process

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1.4.3 White blood cell measurement

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1.4.3.1 Laser flow cytometry
When a certain amount of blood cells is aspirated and cytochemically stained with a specific amount of reagent, the
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blood cell will be injected to a conical flow chamber fulfilled with diluent through nozzle. Wrapped by sheath flow
formed by diluent, the cells will flow through the center of flow chamber singly in row and line, as shown in the
figure below:
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Fig. 1-4-7 Flow cell


When the blood cells suspended in sheath flow pass the laser detection area after quadratic acceleration, the blood
cells will be irradiated by laser beam. The property of scattered light generated is related to the cell size, the
cytomembrane and the index of refraction of intracellular structure. Low-angle forward scattered light reflects the
size and volume of cells and the middle-angle forward scattered light and high-angle forward scattered light reflect
the internal fine structure and particulate matter of cells. Photodiode receives these scattered light signals and
converts them into electric impulse. Based on the electric impulse data collected, the 2D distribution diagram (called
scattergram) of blood cell size and cell internal data will be obtained. The abscissa shows the internal structure
complexity data of cells and the ordinate shows the volume of cells, as shown in the figure below.

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Fig. 1-4-8 Five-part differential scattergram


From the DIFF channel scattergram, the percentage of lymphocyte, monocyte, eosinophil and neutrophil in total
number of white blood cell can be obtained.

BF-6900 has one DIFF scattergram, which is obtained from low-angle forward scattered light and
middle-angle forward scattered light.
BF-6960 has three DIFF scattergrams, which are obtained from low-angle forward scattered light,

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middle-angle forward scattered light and middle-angle forward scattered light respectively.

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From the BASO channel scattergram, the percentage of white blood cell, basophil and eosinophil in total number of
white blood cell can be obtained.

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1.4.3.2 White blood cell parameters
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Through the analysis of BASO channel scattergram and its BASO region, the number of WBC and basophil
(BASO#) is got and then the percentage of basophil (BASO%) can be calculated. The Analyzer gets the percentage
of lymphocyte (LYM%), neutrophil (NEU%), monocyte (MON%) and eosinophil (EOS%) through the analysis of
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DIFF channel scattergram and the LYM zone, NEU zone, MON zone and EOS zone in it. Based on the number of
white blood cells acquired with electrical impedance method, the number of lymphocytes (LYM#), neutrophils
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(NEU#), monocytes (MON#) and eosinophils (EOS#) is obtained. The counting unit of the cells above is 109/L.
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(1)White blood cell


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WBC=Total number of all particles in the BASO channel, except from ghost region.
(2)Basophil
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BASO#=The number of particles in BASO region in BASO channel.


(3)Percentage of basophil
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BAS #
BAS%   100%
WBC
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(4)Percentage of lymphocyte

(5)Percentage of neutrophil

(6)Percentage of monocyte

(7)Percentage of eosinophil

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(8)Lymphocyte

(9)Neutrophil

(10)Monocyte

(11)Eosinophil

1.4.4 Hemoglobin concentration measurement - colorimetric method


1.4.4.1 Hemoglobin concentration measuring principle
SLS-hemoglobin method combines the cationic surface active agent and hemoglobin. The hemoglobin has a quick
conversion speed and does not adopt poisonous substances. It is suitable for automatic detection instruments.
The hemoglobin concentration shall be measured with the SLS-hemoglobin method. In a colorimeter cell, after the
diluted sample is dispensed to lyse, the red blood cell will dissolve and generate hemoglobin. The combination of

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the hemoglobin and lyse will generate hemoglobin compound. On one end of the colorimeter cell, LED luminotron

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passes a monochromatic light with wavelength of 540nm to reflect the hemoglobin compound solution. On the other
end, it passes phototube to receive transmission light and converts the light intensity signal to voltage signal after

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amplification. Through the comparison with the voltage generated by the transmission light intensity before the
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sample is dispensed to the colorimeter cell (only diluent in the colorimeter cell), the hemoglobin concentration
(HGB) of sample can be obtained and the unit is g/L. The measurement and calculation are completed by the
Analyzer automatically and the results will be displayed in the analysis results area on the counting interface.
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Background transmission intensity


HGB  Constant  Log10
Sample transmission intensity
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1.4.5 Red blood cell/ platelet measurement


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1.4.5.1 Electrical impedance method


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The Analyzer uses the electrical impedance method to count red blood cells/ platelets (as shown in Fig. 1-4-11). The
red blood cell/ platelet sample will enter RBC test unit after secondary dilution. The test unit has a small hole for test.
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At the two sides of the hole, there is a pair of positive and negative electrode to connect constant current power
supply. As the cells have the features of poor conductor, the DC resistance between electrodes will change when the
cells in diluted sample pass the small detection hole under constant negative pressure and pulse signal in proportion
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to the cell volume and size will be formed at the two ends of electrode. When cells pass the small hole continuously,
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a string of electric pulses will be generated at two ends of the electrode. The number of pulses and the number of
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cells passing the small hole are equivalent and the pulse magnitude is in direct proportion to the volume of cell.

Fig. 1-4-9 Counting principle diagram

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After the collected electric pulse is amplified, it is compared with the channel voltage threshold corresponding to the
volume range of normal red blood cell/ platelet. And then, the number of electric pulses of pulse amplitude in red
blood cell/ platelet channel will be calculated. The collected electric pulses are classified according to different
channel voltage threshold and the number of electric pulses in red blood cell/ platelet channel is just the number of
red blood cells/ platelets. The number of cells in each channel divided according to the pulse voltage range
determines the volume distribution of cells. The abscissa shows the volume of cell and the ordinate shows the 2D
diagram of cell quantity, i.e. the histogram reflecting the cell group distribution.
1.4.5.2 Red blood cell parameters
(1)Number of red blood cells
The Analyzer gets the number of red blood cells (RBC) by the direct measurement of the number of electric pulses
of red blood cell, and the unit is 1012/L.
RBC  n  1012 / L

(2)Mean red blood cell volume


The Mean red blood cell volume (MCV) can be calculated according to the red blood cell distribution histogram,
and the unit is fL.
(3)Red blood cell hematocrit, mean red blood cell hemoglobin content, mean red blood cell hemoglobin

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concentration

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With the formulas below, the red blood cell hematocrit (HCT) (unit: %), mean red blood cell hemoglobin content
(MCH) (unit: pg) and mean red blood cell hemoglobin concentration (MCHC) (unit: g/L) can be calculated.

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RBC  MCV
HCT 
RBC hematocrit 10 CO
HGB
MCH =
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Mean hemoglobin content RBC

HGB
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MCHC   100
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Mean hemoglobin concentration HCT

The unit of RBC is 1012/L, the unit of MCV is fL and the unit of HGB is g/L.
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(4)Red blood cell distribution width variation coefficient


The red blood cell distribution width variation coefficient (RDW-CV) is obtained from the red blood cell
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distribution histogram. It is a variation coefficient showing volume distribution in percentage.


(5)Standard deviation of red blood cell distribution width
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The deviation limit of red blood cell distribution width (RDW-SD) is the width at peak 20% in histogram of red
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blood cell distribution and the unit is fL, as shown in the figure.
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Fig. 1-4-10 Diagram


(6)Red blood cell distribution histogram
The Analyzer can provide a red blood cell volume distribution graph while providing the red blood cell counting
results. The graph that shows the distribution of cells is called red blood cell distribution histogram. On the
histogram, the abscissa shows the volume of red blood cell (unit: fL) and the ordinate shows the relative number of
red blood cell (unit: 1012/L). After each counting, the red blood cell distribution histogram can be checked in the
analysis results area on counting interface or by query on the query interface.

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1.4.5.3 Platelet parameters


(1)Platelet number (PLT)
The Analyzer gets the number of platelets by the direct measurement of the number of electric pulses of platelet, and
the unit is 109/L.
PLT  n  109 / L

(2)Mean platelet volume (MPV)


The mean platelet volume can be calculated according to the platelet distribution histogram, and the unit is fL.
(3)Platelet distribution width (PDW)
The platelet distribution width is obtained from the platelet distribution histogram and it is geometric deviation limit
(10GSD) of platelet volume distribution.
(4)Platelet hematocrit (PCT)
The Analyzer calculates the platelet hematocrit (unit: %) with the formula below. The unit of PLT is 109/L and the
unit of MPV is fL.
PLT  MPV
PCT 
10000

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(5)Proportion of large platelet (P-LCR)

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The proportion of large platelet can be obtained from the platelet histogram. It is the proportion of large platelet in

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platelet.
(6)Large platelet counts (P-LCC)
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The count of large platelet can be obtained from the platelet histogram. It is the count of large platelets in platelet.
(7)Platelet distribution histogram
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The Analyzer can provide a platelet volume distribution graph while providing the platelet counting results. The
graph that shows the distribution of cells is called platelet distribution histogram. On the histogram, the abscissa
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shows the volume of platelet (unit: fL) and the ordinate shows the relative number of platelet (unit: 109/L). After
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each counting, the platelet distribution histogram can be checked in the analysis results area on counting interface or
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by query on the query interface.


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1.4.6 Rinsing
The Analyzer will rinse the components where sample flows automatically in each counting period to ensure no
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sample left in liquid path.


(1)The internal and external sides of the sampling probe are rinsed with BF-5D diluent.
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(2)The count cell is rinsed with BF-5D diluent.


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(3)The flow chamber is rinsed with BF-5D diluent.


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1.5 Structure of the instrument


The Analyzer is composed of a host (including mechanical motion system, optical system, fluid circuit system,
electronic control system and software system) and an optional module (sample feeder).

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1.5.1 Front view of the Analyzer

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1 Front door 2 Display screen 3 Emergency position 4 Count key 5 Sample feeder

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Fig. 1-5-1 Front view of the Analyzer

1.5.2 Rear view of the Analyzer


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1 Upper cover 2 Right side door assembly 3 Back plate 4 Power vent 5 Waste liquid level sensor port
6 Diluent port 7 Waste liquid port 8 Left side door assembly 9 Power vent
10 Power switch/ power socket/ power filter
Fig. 1-5-2 Rear view of the Analyzer

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1.5.3 Left view of the Analyzer

1 USB interface 2 USB interface 3 RJ45 network interface 4 Test switch 5 Door lock

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Fig. 1-5-3 Left view of the Analyzer

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1.6 External device of the Analyzer

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(1)Printer: It is connected with the instrument directly and it prints reports through the software of the instrument.
The instrument supports the following printer:
HP LaserJet Pro 400 M401d / HP LaserJet Pro 400 M403d.
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(2)Bar code reader: It is connected with the instrument directly and it can input the bar code information quickly.
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The bar code reader is included in the standard configuration.


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1.7 Symbol
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Table 1-7-1
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Symbols Meaning
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Biohazard, reminding the user to pay attention; otherwise there is risk of potential
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bio-infectivity
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LASER, DANGER SYMBOL

ALTERNATING CURRENT

IN VITRO DIAGNOSTIC MEDICAL DEVICE

BATCH CODE

USE BY

SERIAL NUMBER

DATE OF MANUFACTURE

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Symbols Meaning

MANUFACTURER

THE DEVICE MEETS THE REQUIREMENTS OF DIRECTIVE ON IN VITRO


DIAGNOSTIC MEDICAL DEVICES

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

CAUTION, REFER TO THE ACCOMPANYING FILES OR MARK DETAILED


WARNING OR MATTERS NEEDING ATTENTION

CATALOGUE NUMBER

Do not contact the sampling probe when the instrument is working.

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"ON" (POWER)

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"OFF" (POWER)
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PROTECTIVE EARTH
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The symbol of the crossed out wheeled bin indicates that the product (electrical and electronic
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equipment) should not be placed in municipal waste. Please check local regulations for
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disposal of electronic products.


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Temperature limit
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Humidity limitation
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Atmospheric pressure limitation

Caution, hot surface

USB

network interface

The symbols above are also applicable to the Analyzer, reagent, QC object and calibration object.

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1.8 Identification

(1)

(2) (It is pasted on the optical system inside the instrument)

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Chapter 2 Installation

To ensure the normal operation of the Analyzer after the installation, the Analyzer shall be installed by the
authorized operators of the manufacturer at the delivery.

2.1 Installation requirements


The Analyzer can only be installed after the following space, power and environmental requirements are met. The
Analyzer shall be placed on a horizontal operation platform instead of a sloping platform. The platform shall
withstand 48kg at least.
Remarks: Weight of host: 40kg; sample feeder: 8kg.
2.1.1 Space requirements
For a proper servicing and repair of the Analyzer, following conditions shall be met when the Analyzer is installed:
(1)The distance from the instrument at its left and right sides to the wall shall not be shorter than 50cm.
(2)The distance from the rear panel of the instrument to the wall shall not be shorter than 50cm.

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(3)The distance from the front instrument to other instruments shall not be shorter than 100cm.

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(4)Sufficient space shall be guaranteed on the operation platform or under the Analyzer for placing collecting
devices of diluent, reagent and waste liquid.

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2.1.2 Power requirements
(1)Supply voltage: 100-240V~, 50/60Hz. CO
(2)Power consumption: 240VA.
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(3)Fuse specification: F4AL250V 5mm×20mm.


(4)To maintain its successful operation, the power supply shall be reliably grounded and do not plug the Analyzer
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into the same receptacle with electrical equipment with a heavy load such as air conditioner, refrigerator and oven.
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2.1.3 Environmental requirements


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(1)Normal working conditions


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a)Ambient temperature: 10℃~30℃.


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b)Relative humidity: Not exceeding 70%.


c)Atmospheric pressure: 75kPa~106kPa.
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d)The Analyzer shall be put in a dust-free environment without mechanical vibration, source of large noise and
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power interference.
e)It is recommended to evaluate the electromagnetic environment in laboratory before operating the Analyzer.
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f)Do not have the Analyzer closing to the interference source of high electromagnetic, lest it may interfere with
the normal operation of the Analyzer.
g)Do not put the Analyzer near brush motor, scintillant fluorescent lamp and electrical contact equipment often
used.
h)The Analyzer shall be prevented from direct sunlight exposure and not be placed near heat and wind sources.
i)The environment shall be well-ventilated and the ventilating device shall be used if necessary. But the Analyzer
should be protected from the direct airflow, otherwise, the test accuracy may be affected.

If the operating environment or power supply of the Analyzer do not meet the requirements above, the
accuracy and precision of test results of the Analyzer may be affected, the Analyzer may be damaged or
personal injury may be caused.
(2)Safety conditions
a)Indoor use;
b)Altitude shall not exceed 2000m.

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c)Ambient temperature: 5℃~40℃.


d)The maximum relative humidity is 80% when the temperature is lower than 31℃; the relative humidity has a
linear decrease by 50% if the temperature is 40℃.
e)The fluctuation of power voltage is not greater than ±10% of nominal voltage.
f)The transient overvoltage is installation category (overvoltage category) II.
g)The pollution is in Class 2.
h)Waterproof grade: IPX0.
i)Material grade: III a.

2.2 Unpacking
2.2.1 Unpacking steps
After the instrument arrives, please open the case according to the following steps:
(1)Make the anti-inclination sign on the packing case upright. Verify that the package is complete,
and the appearance of the package does not allow sharp penetration injury and heavy extrusion
leading to deformation which causes the loss of protective function of the packaging case. If there is
any damage, please contact the manufacturer or local agent.

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(2)Take out the host and accessories; check whether the host and accessories are complete according
to the packing list. If there is any missing, please contact the manufacturer or local agent.

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(3)Check the appearance of the system carefully. If there is any damage, please contact the manufacturer or local
agent.
2.2.2 Handling method
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(1)Use transport machine such as utility trolley for the stable transportation of short distance.
(2)Prevent the aspiration probe from other objects and being damaged during handling and transportation processes.
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(3)Keep the Analyzer vertical, not tilting or side laying when moving and carrying.
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(4)Try to avoid vibration when handling.


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2.2.3 Instrument internal fixing devices removal instructions


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(1)Open the front door of the instrument:


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a)Unscrew three fixing screws for the right door, remove the right door of the instrument, and then unscrew the
right fixing screw for the front door, as shown in the following figure:
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Fig. 2-2-1

b)Open the left door of the instrument and unscrew the left fixing screw of the front door, as
shown below:

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Fig. 2-2-2
c)Open the front door of the instrument as shown in the figure:

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Fig. 2-2-3
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(2)Remove the rubber plug of the reaction cell as shown in the figure:
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Fig. 2-2-4
(3)Remove the probe fastener: unscrew the two cross recessed pan head combination screws in the figure below and

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remove the probe fastener, as shown in the figure:

Fig. 2-2-5
(4)If a sample feeder is selected, the mixing unit fastener needs to be removed: open the front door, and screw down

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the cross recessed pan head combination screw for fixing the isolation sleeve. Remove the isolation sleeve; then

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screw down the two cross recessed pan head combination screws that fix the fastener and remove the fastener, as
shown in the following figure:

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Fig. 2-2-6
(5)According to the order of c), b) and a) in step (1), fix the instrument front door and right door again.
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2.3 Instrument installation


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Do not disassemble or install the instrument except for the normal maintenance.

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1 Waste liquid level sensor port 2 BF-5D diluent port 3 Waste liquid port

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Fig. 2-3-1 Connection of the instrument and reagent

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1 BF-FBH lyse port 2 BF-FDTⅠ lyse port 3 BF-FDOⅠ lyse port


Fig. 2-3-2 Connection with reagent inside the instrument
(1)Connection with lyse, diluent and waste liquid
Open the left side door of the instrument and place the bottles of BF-FDT I lyse, BF-FDO I lyse, BF-FBH lyseinside
the instrument and connect them in accordance with signs in Fig. 2-3-2.
Place the BF-5D diluent tank and waste liquid tank of the instrument under the operation platform and connect them
in accordance with signs in Fig. 2-3-1.

● The height difference between the waste liquid tank and the waste liquid port of the instrument shall not be
less than 0.5m.
● The waste liquid shall be discharged in accordance with the local regulations on the disposal of medical
waste.
● The drainage system shall be in compliance with the local regulations with regard to sewage discharge and

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treatment of medical institutions.


(2)Connection of waste liquid level sensor
Connect the other end of the accompanying waste liquid level sensor with the "waste liquid sensor port" on the back
plate of the Analyzer (1 in Fig. 2-3-1), and insert the liquid level sensor in the waste liquid tank in accordance with
the marks on the wires.
(3)Connection of computer

Connect "the network interface" of the computer with " " (3 in Fig. 1-5-3) on the right panel of the Analyzer.
(4)Connection of power cable
Plug one end of the accompanying power cable into the power socket on the right panel of the Analyzer (10 in Fig.
1-5-2), and plug the host power cable, display power cable and printer power cable.

● The receptacle connected with the power cable shall be reliably grounded.
● Do not put the instrument at a place where the disconnecting device is hard to be operated.
(5)Connection of bar code reader

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Connect another end of accompanying bar code reader with any " " interface on the instrument.

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The bar code reader will emit light harmful to people's eyes, please do not look straight at the light when the
Analyzer is working.
(6)Connection of printer
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Use a data cable to connect the printer and the interface of the Analyzer correctly and check the
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specification of printing paper used by the printer.


Plug one end of the printer power cable to the supply socket of the printer and plug the other end to the socket.
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In the transportation process, to prevent damage to the aspiration probe, moving mechanisms of the instrument have
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been fixed when the instrument is delivered.Before the instrument is powered on, the fixing screws and tie shall be
removed first, or the aspiration probe may be damaged.
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2.4 Turn-on and user login


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Operating environment requirements: ARM


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Software environment: Linux


Network conditions: LAN data exchange and transmission, LAN relatively independent, physically isolated from
other network devices.
Data and device (system) interfaces:
The software exchanges data through hardware devices. These hardware devices include USB flash drives and SD
card storage devices. The software imports data through peripheral USB interfaces or SD cards.
Data exchange and transmission between PC and embedded software modules can be realized via the LIS system in
TCP LAN.
User access control mechanism: In order to ensure the safety of products and data, the instrument divides operators
into two levels of authority, i.e., ordinary users and the administrators (the administrator has all the rights over the
user).
2.4.1 User login
Turn on the power switch and the display will show “System Loading…”. After the system finishes initialization, a
login dialog box will pop up, as shown in the figure.

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Fig. 2-4-1
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In the login dialog box, input the correct user name and password, the initial user name of the instrument is admin,
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and the initial password is 1, if a wrong user name and password are input, login failure will appear, and the
interface is as shown in the figure below:
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Fig. 2-4-2
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The user name and the password are composed of lower and upper case English letters or figures (1-12
characters).
After logging in, the instrument enters the initialization interface to initialize. It performs version verification,
transmission gain, mechanical reset, sending mode, reagent residue detection, pipeline rinsing, background
detection, temperature detection and blank test.

● The blank result obtained during the blank test is beyond the range set by the software and the instrument
will perform the blank test again. If the result is still not qualified after tested 3 times, "blank test error" will
be prompted.
● The instrument will not have High valve, Low value or Suspicious alarms for the blank test results.
● When the power-on self-check alarm triggers, the instrument enters the main interface. Click the red
exclamation mark to check corresponding alarm information. After the alarm is cleared, the instrument
performs self-check again.
After the instrument finishes the self-check, enter the main window of the software, as shown in the figure below:

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Fig. 2-4-3
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2.4.2 Description of counting interface
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2.4.2.1 Menu
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Click the [Menu] to pop up the menu as shown in the figure. The functions in the menu bar are described as follows:
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Fig. 2-4-4
Spl. Reg.: Have sample registration and work list input.
Calibration: Calibrate the instrument.
Q.C.: L-J/Xbar, Xbar-R, X-B quality control.
Maint.: Check the status of the instrument and have maintenance and check of the instrument.
Settings: Set parameters of the instrument.
Log: Record system operating information and error information.
Reagent: reagent registration and reagent information settings.

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Logout: Switch between users and log in software interface with a new user identity.
Shutdown: Turn the instrument off.
2.4.2.2 Public information area
The public information area is shown in the lower part of the counting interface, as shown in figure below

Total number of locations Current mode Test status

Fig. 2-4-5
(1)Total number of locations: Display the current sample serial number and total sample size
(2)Current status: Display the analysis mode of the sample.
(3)Test status: Indicate the current status of the instrument.
2.4.2.3 Status indication area
On the right side of Fig. 2-4-5 is the status indication area. The area displays in sequence the X-B QC switch status,
U disk connection status, LIS system connection status, and printer status, described as follows:

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(1)X-B QC switch status:

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: The X-B quality control is on.

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: The X-B quality control is not turned on.
(2)USB status:
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: The USB storage device is connected.


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: The USB storage device is not yet connected.


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(3)LIS system connection status:


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: The LIS is connected.


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: The LIS is not yet connected.


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(4)Printer status:
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: The printer is connected.


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: The printer is not yet connected.


2.4.2.4 Shortcut area

Fig. 2-4-6
(1)Spl. analysis: Finish sample test and the analysis and display of test results on the interface.
(2)History: The instrument will automatically save the analysis results in the database after executing sample
analyzing each time. The operator can query all sample results stored in the database.
(3)QC: Enter the QC interface to realize the basic setting of QC and QC counting.
(4)Add diluent: Dispense diluent for the preparation of pre-dilution sample under the pre-dilution mode.
(5)Rinse: Manually clean equipment.
(6)Print: Print the reports of selected samples.

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(7)Fault information area:


In case of failures of the instrument, relevant failure level information will be displayed in the area. At the moment,
click the area to pop up a failure display dialog box, as shown in the figure below:

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Fig. 2-4-7
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After clicking relevant failure information, the detailed solution to the failure will be displayed in the "Alarm help"
and the user can have simple troubleshooting according the solution.
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2.5 Gas & liquid path diagrams


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Fig. 2-5-1

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Fig. 2-5-2

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Fig. 2-5-3

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Fig. 2-5-4
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Chapter 3 Setting of the Analyzer

3.1 Overview
The system parameters of the instrument have had initialization setting in the factory. The interface shown at the
first turn-on of the instrument is the default interface. To meet different demands in actual use, the software sets two
identities, user and administrator. Users with different identities can reset different parameters.

3.2 Mode setting


Turn on the instrument, log in the software successfully and enter the sample analysis interface, then click the
[Mode] to pop up a mode setting dialog box, as shown in the figure below:

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Fig. 3-2-1
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(1)Next No.: Enter the number of the next sample to be analyzed in the input box.
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(2)Next bar code: What is input in the box is the barcode number of the next manual analysis sample.

The sample number can only be entered in figure or "-", and its beginning and ending must be numeric and
up to 12 digits.
(3)Analysis mode: There are totally four modes, among which the [WB], [Micro-WB] and [Pre-dilute] modes are
manual analysis modes and [Auto-WB] mode is an automatic analysis mode.

The automatic-whole blood mode can only be used during the assembly of the sample feeder.
(4)Test mode: there are totally four modes;
"CBC" mode: count only, with no classification of the white blood cells. The count result comprises of histograms
of the RBC and PLT and other parameters.
"CBC+DIFF" mode: in addition to counting, it also has five differential classifications of the white blood cells,
including 25 parameters and scattergrams and histograms.
(5)Tube number and rack number: If the [Auto-WB] mode is selected and [Auto-identify] is not selected, the [Rack

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No.] and [Tube No.] will change to an editable state and the rack number and tube number can be reset in the box
following [Rack No.] and [Tube No.].
(6)Use worklist: use the manually entered or downloaded worklist for testing.
(7)Two-way LIS: when bi-directional LIS is set, after the testing is started, the instrument will obtain a worklist
from LIS terminal automatically and then conduct test. After the testing, the worklist information and test results
will be transmitted to LIS terminal.
(8)Auto-COM.: After connection to the LIS, automatically transmit the test results after the testing.

If a barcode reader is not connected, the “Two-way LIS” option will not be displayed on the interface.

3.3 Unit settings


Click [Menu] - [Settings] - [Unit], as shown in Fig. 3-3-1:

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Fig. 3-3-1
Click the corresponding input box of the unit following each test item and select a different unit as the test unit
according to actual demand.
After inputting, click [Save] to confirm, and when "Saved successfully" is prompted, press [OK] on the interface.
Click [DEF] to restore the unit to the default settings.
Unit of each test item: several units for the setting of each test item of the instrument are available for the user to
choose and specific setting unit is as shown in Table 3-3-1:
Table 3-3-1

Parameters Unit Numeric form Remarks

109/L ***.** Default unit

103/μL ***.**
WBC
102/μL ****.*

/nL ***.**

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Parameters Unit Numeric form Remarks

LYM#, MON#, BAS#, EOS#, NEU# 109/L ***.** Default unit

LYM%, MON%, BAS%, EOS%, NEU% % **.* Default unit

1012/L **.** Default unit

106/μL **.**
RBC
104/μL ****

/pL **.**

g/L *** Default unit

HGB g/dL **.*

mmol/L **.*

fL ***.* Default unit


MCV, RDW-SD
μm3

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pg **.* Default unit
MCH

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fmol ***

g/L *** CO Default unit

MCHC g/dL ***.*


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mmol/L ***.*
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RDW-CV % **.* Default unit


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% **.*
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HCT
L/L *.*** Default unit
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109/L **** Default unit


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103/μL ****
PLT, P-LCC
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104/μL ***.*
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/nL ****
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fL **.* Default unit


MPV
μm3 ***.*

PDW fL **.* Default unit

% .*** Default unit


PCT
mL/L *.**

P-LCR % **.* Default unit

After the unit of the parameter is changed, the data format of the test result also changes.

3.4 Reference values setting


The instrument has ordinary, adult male, adult female, child, newborn and five custom reference ranges, and the
default is "Ordinary". Each laboratory should select an appropriate reference range according to the actual sample
condition and set an appropriate reference interval.

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Click [Menu] - [Settings] - [Reference value], as shown in Fig. 3-4-1:

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Fig. 3-4-1
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Input of reference value lower and upper limits:


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Click the corresponding input box of lower and upper limits following each test item and directly input the lower
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and upper limits of corresponding test item.


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After the limits are input, press [Save] for confirmation. When a prompt information of "Saved successfully" pops
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up, click [OK] on the interface to save.


Click [DEF] to restore the default lower and upper reference values.
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3.5 Abnormity flags setting


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Click [Menu] - [Settings] - [Abno.flag] and select [WBC], as shown in the figure below:
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Select [RBC/PLT] and the interface is as shown in the figure below:
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Fig. 3-5-2
Select [Suspicious mark], as shown in the figure below:

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Fig. 3-5-3
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On this interface, the user can set the prompt range of WBC, RBC/ PLT and the abnormal alarm information of
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suspicious marks.
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After the values are input, click [Save] to save the settings or click [DEF] to restore the default value.
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3.6 QC setting
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3.6.1 QC method
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Click [Menu] - [Settings] - [QC], as shown in the figure below:


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Fig. 3-6-1
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The user can select the QC mode. After saving the settings, the user can click "QC" on the shortcut key interface to
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go to the corresponding QC interface.


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3.6.2 L-J setting


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Select [L-J] and the interface is as shown in the figure below:


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Fig. 3-6-2
In the figure above, users can select the L-J QC calculation method and range:

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Calculation and range selection of deviation:


(1)If [Absolute value] is selected as the calculation method, the deviation limit input will be displayed in the form of
an absolute value, and 2SD or 3SD will be displayed on [Range] as deviation limit.
(2)If [Percentage] is selected as the calculation method, the deviation limit input will be displayed in the form of a
percentage, and 2CV or 3CV will be displayed on [Range] as deviation limit.
3.6.3 Xbar setting
Select [Xbar], as shown in the figure below:

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Fig. 3-6-3
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In the figure above, users can select the Xbar QC calculation method and range:
Calculation and range selection of deviation:
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(1)If [Absolute value] is selected as the calculation method, the deviation limit input will be displayed in the form of
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an absolute value, and 2SD or 3SD will be displayed on [Range] as deviation limit.
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(2)If [Percentage] is selected as the calculation method, the deviation limit input will be displayed in the form of a
percentage, and 2CV or 3CV will be displayed on [Range] as deviation limit.
3.6.4 X-B setting
Select [X-B] and the interface is as shown in the figure below:

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Fig. 3-6-4
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The user can choose X-B QC switch and set sample volume.
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3.7 Information setting


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Click [Menu] - [Settings] - [Info], as shown the figure below:


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Fig. 3-7-1
(1)Department: Click [Add] to add department information in the popup interface as shown in the figure below:

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Fig. 3-7-2
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Select the row where the department information to be deleted is, click [Delete] in the figure to pop up the prompt as
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shown in the figure below:


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Fig. 3-7-3
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Click [OK] to delete corresponding department information.


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(2)Doctor: Select [Doctor], the interface shown in the figure below:

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Fig. 3-7-4
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Click [Add] to add doctor information in the popup interface as shown in the figure below:
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Fig. 3-7-5
Select the row where the doctor information to be deleted is, click [Delete] in the figure to pop up the prompt as
shown in the figure below:

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Fig. 3-7-6
Click [OK] to delete corresponding doctor information.
(3)Cost type: Select [Cost type], the interface shown in the figure below:

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Fig. 3-7-7
Click [Add] to add charge information in the popup interface as shown in the figure below:
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Fig. 3-7-8
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Select the row where the charge information to be deleted is, click [Delete] in the figure to pop up the prompt as
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shown in the figure below:


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Fig. 3-7-9
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Click [OK] to delete corresponding charge information.


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When adding the department, doctor, and cost type, it is not allowed to input special characters.

3.8 User settings


Click [Menu] - [Settings] - [User], as shown the figure below:

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Fig. 3-8-1
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(1)Add user: Click [Add user] in the figure to add user information as shown in the figure below:
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Fig. 3-8-2
Fill in the user, name, password, confirm password and select permission according to the corresponding prompt
and click [Save] to complete the operation.

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● The user settings are only available to administrators.


● When adding a user, the administrator needs to note the followings:
(1)The existing user name cannot be added.
(2)The user name, name, and password cannot be null.
(2)Delete user: In Fig. 3-8-1, select the row of the user information to be deleted, and click [Delete user] to pop up
the prompt as shown in the figure below:

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Fig. 3-8-3

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Click [OK] to delete corresponding user information.

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(3)Change password: In Fig. 3-8-1, select the row of the user information that you want to change your password
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and click [Modify PWD], as shown in the figure below:


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Fig. 3-8-4
In the figure, enter the old password and new password respectively, and click [Save] to save the modified
password.

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