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

DESCRIPTION

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

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 .......................................................................................................................................... 1-6
1.4.4 Hemoglobin concentration measurement - colorimetric method ....................................................................................... 1-8
1.4.5 Red blood cell/ platelet measurement ................................................................................................................................ 1-8
1.4.6 C-reactive protein measurement ...................................................................................................................................... 1-10
1.4.7 Rinsing ............................................................................................................................................................................ 1-10

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1.5 Structure of the instrument ......................................................................................................................... 1-11

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1.5.1 Front view of the Analyzer .............................................................................................................................................. 1-11
1.5.2 Rear view of the Analyzer ............................................................................................................................................... 1-11

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1.5.3 Left view of the Analyzer ................................................................................................................................................ 1-12
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1.6 External device of the Analyzer................................................................................................................... 1-12
1.7 Symbol ........................................................................................................................................................... 1-12
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1.8 Identification ................................................................................................................................................. 1-14

Chapter 2 Installation .....................................................................................................................2-1
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2.1 Installation requirements ............................................................................................................................... 2-1

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2.1.1 Space requirements............................................................................................................................................................ 2-1

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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

2.2.1 Unpacking steps ................................................................................................................................................................ 2-2
2.2.2 Handling method ............................................................................................................................................................... 2-2
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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

2.4.1 User login .......................................................................................................................................................................... 2-7
2.4.2 Description of counting interface ...................................................................................................................................... 2-8
2.5 Gas & liquid path diagrams......................................................................................................................... 2-11
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 ................................................................................................................................. 3-4
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

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3.6.4 X-B setting ........................................................................................................................................................................ 3-8

3.6.5 CRP setting........................................................................................................................................................................ 3-9
3.7 Information setting ....................................................................................................................................... 3-10
3.8 User settings .................................................................................................................................................. 3-14
3.9 Instrument setting......................................................................................................................................... 3-17
3.9.1 Sleep setting .................................................................................................................................................................... 3-17
3.9.2 Automatic rinsing setting ................................................................................................................................................ 3-17
3.9.3 Blocked hole setting ........................................................................................................................................................ 3-18
3.9.4 Other................................................................................................................................................................................ 3-19
3.10 Software setting........................................................................................................................................... 3-19
3.10.1 Date format setting ........................................................................................................................................................ 3-19
3.10.2 Print settings .................................................................................................................................................................. 3-20
3.10.3 Network settings ............................................................................................................................................................ 3-21
3.10.4 Language settings .......................................................................................................................................................... 3-22
3.10.5 Other setting .................................................................................................................................................................. 3-23
3.11 CRP settings ................................................................................................................................................ 3-23

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Chapter 4 Calibration.....................................................................................................................4-1

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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
4.4.1 Input of calibrator reference value..................................................................................................................................... 4-2
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4.4.2 Calibration counting .......................................................................................................................................................... 4-2

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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

4.5.3 Save calibration coefficient ............................................................................................................................................... 4-6
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4.6 Manual calibration ......................................................................................................................................... 4-7

4.7 CRP 2-point calibration ................................................................................................................................. 4-8
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4.8 CRP multi-point calibration .......................................................................................................................... 4-9

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4.9 CRP blank correction ................................................................................................................................... 4-11

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4.10 CRP manual calibration............................................................................................................................. 4-12

4.11 Calibration history ..................................................................................................................................... 4-12
Chapter 5 QC ..................................................................................................................................5-1
5.1 Overview .......................................................................................................................................................... 5-1
5.2 L-J QC ............................................................................................................................................................. 5-1
5.2.1 Setting ............................................................................................................................................................................... 5-2
5.2.2 QC count ........................................................................................................................................................................... 5-3
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

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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
5.6 CRP QC ......................................................................................................................................................... 5-17
5.6.1 Setting ............................................................................................................................................................................. 5-18
5.6.2 QC count ......................................................................................................................................................................... 5-19
5.6.3 QC diagram ..................................................................................................................................................................... 5-21
5.6.4 QC list ............................................................................................................................................................................. 5-23
Chapter 6 Sample registration .......................................................................................................6-1
6.1 Overview .......................................................................................................................................................... 6-1
6.2 Edit information ............................................................................................................................................. 6-1
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

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Chapter 7 Routine operation .........................................................................................................7-1

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7.1 Overview .......................................................................................................................................................... 7-1

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7.2 Preparation for operation .............................................................................................................................. 7-1
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7.3 Turn-on ............................................................................................................................................................ 7-2
7.4 Daily QC .......................................................................................................................................................... 7-2
7.5 Sample preparation ........................................................................................................................................ 7-2
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7.5.1 Test tube types................................................................................................................................................................... 7-2

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7.5.2 Whole-blood sample.......................................................................................................................................................... 7-3

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7.5.3 Peripheral blood sample .................................................................................................................................................... 7-3

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7.6 Whole-blood sample analysis ......................................................................................................................... 7-5

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7.6.1 Sample analysis steps ........................................................................................................................................................ 7-5

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

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7.8.2 Change of mode .............................................................................................................................................................. 7-10

7.8.3 Sample analysis steps ...................................................................................................................................................... 7-11
7.9 Analysis of emergency samples.................................................................................................................... 7-11
7.10 Parameter alarm ......................................................................................................................................... 7-13
7.10.1 Parameter alarm type ..................................................................................................................................................... 7-13
7.10.2 Abnormal alarm for classification or morphology ......................................................................................................... 7-13
7.11 Sleep ............................................................................................................................................................. 7-15
7.12 Rinsing and unblocking.............................................................................................................................. 7-15
7.13 Turn-off ....................................................................................................................................................... 7-15
Chapter 8 History query ................................................................................................................8-1
8.1 Overview .......................................................................................................................................................... 8-1
8.2 Selection of record .......................................................................................................................................... 8-1
8.3 Query ............................................................................................................................................................... 8-2
8.4 Audit and cancel audit.................................................................................................................................... 8-2

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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
9.3.1 Basic status ........................................................................................................................................................................ 9-2
9.3.2 System version .................................................................................................................................................................. 9-3
9.3.3 Service ............................................................................................................................................................................... 9-3

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9.3.4 HGB verification ............................................................................................................................................................... 9-9

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9.3.5 Mechanical detection ......................................................................................................................................................... 9-9
9.3.6 Instrument registration .................................................................................................................................................... 9-13

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9.3.7 Data backup ..................................................................................................................................................................... 9-13
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9.3.8 Counter ............................................................................................................................................................................ 9-14
9.4 Replacement of vulnerable parts ................................................................................................................. 9-15
9.4.1 Replacement of sampling probe ...................................................................................................................................... 9-15
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9.5 Maintenance of the instrument before stopping using .............................................................................. 9-16

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9.6 Rinsing and maintenance of the instrument............................................................................................... 9-16

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9.7 Disposal of waste liquid ................................................................................................................................ 9-17

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9.8 Disposal of discarded instrument ................................................................................................................ 9-17

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Chapter 10 System log ..................................................................................................................10-1

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10.1 System log .................................................................................................................................................... 10-1

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

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
Chapter 13 Transportation and storage .....................................................................................13-1
13.1 Transportation ............................................................................................................................................ 13-1
13.2 Storage ......................................................................................................................................................... 13-1
Appendix A Letter of guarantee ................................................................................................... A-1
Appendix B Network communication interface protocol V1.7 .................................................. B-1
Appendix C Product description .................................................................................................. C-1
Appendix D Performance indexes ................................................................................................ D-1
Appendix E Parts list ..................................................................................................................... E-1
Appendix F Statement on electromagnetic compatibility .......................................................... F-1

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 User Manual

Chapter 1 Brief introduction

1.1 Overview
The Automatic Hematology Analyzer (model: BF-6900CRP/ BF-6960CRP) 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 27 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, test the c-reactive protein
concentration with latex immunoturbidimetric assay 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-6900CRP BF-6960CRP
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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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MON%, RBC, HGB, MCV, MCH,
Test items
MCHC, RDW-CV, RDW-SD, HCT,
PLT, MPV, PDW, PCT, P-LCR, P-LCC,
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RBC, HGB, MCV, MCH, MCHC,
RDW-CV, RDW-SD, HCT, PLT, MPV,
PDW, PCT, P-LCR, P-LCC, FR-CRP,

FR-CRP, HS-CRP HS-CRP

Five-classification of white blood cell, Five-classification of white blood cell, test
test of 27 parameters, 2 scattergrams and of 27 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

6 types, including 1 type of diluent and 5 6 types, including 1 type of diluent and 5
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-6900CRP BF-6960CRP

White blood cell

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

With sample feeder: 51kg; With sample feeder: 51kg;

Weight
Without sample feeder: 43kg; Without sample feeder: 43kg;

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With sample feeder: With sample feeder:

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

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machine Dimensions
Without sample feeder: Without sample feeder:
system
531mm×380mm×520mm 531mm×380mm×520mm
(H×W×L) CO (H×W×L)

Power
260VA 260VA
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. Latex immunoturbidimetric assay is used to measure the concentration of C-reactive protein. On this
basis, it calculates the results of other parameters.
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1.4.1 Sample aspirating

With different configuration, the instrument provides two sample feeding ways, closed sample feeding and
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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.
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The instrument supports the whole blood, micro-whole blood and pre-dilution modes. Under whole blood mode or
micro-whole blood mode, the Analyzer will aspirate 25μL (CBC+DIFF mode) or 20μL (CBC mode) whole blood
sample; 30μL (CBC+DIFF+CRP mode), 28μL (CBC+CRP mode) or 18μL (CRP mode) whole blood sample.
Under pre-dilution test mode, the operator shall mix the 20μL peripheral blood sample with 180μL dilute outside the
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), 65μL (CBC mode), 150μL
(CBC+DIFF+CRP mode), 85μL (CRP mode) or 135μL (CBC+CRP 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 C-reactive protein
detector, 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 and C-reactive protein 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.

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1.4.2.1 Whole-blood mode

(1)Red blood cell/ platelet dilution process

Whole-blood sample
6μL

Dispense BF-5D
diluent 2500μL

Pre-dilution
Aspirate sample 45μL
Dilution ratio1：418

Dispense BF-5D diluent

to RBC cell 2700μL

Dilute in RBC cell

Dilution ratio 1:25060

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

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(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

Whole blood 6μL

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DIFF test sample

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Dispense BF-FDO I
lyse 500μL

Dispense BF-FDT I
lyse 120μL

1：104

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

(4)C-reactive protein dilution process

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Fig. 1-4-4 C-reactive protein dilution process

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

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Whole-blood sample

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20μL

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BF-5D diluent 180μL
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Dilution ratio is 1:10

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Take 25μL sample

BF-5D diluent 2.0mL
after mixing
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Dilution ratio is 1:810

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Take 70μL sample

BF-5D diluent 2.5mL
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after mixing
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Red blood cell/ platelet test sample

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with dilution ratio of about 1:28928

Fig. 1-4-5 Red blood cell/ platelet dilution process

(2)White blood cell/ hemoglobin dilution process

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Fig. 1-4-6 White blood cell/ hemoglobin dilution process

(3)White blood cell classification dilution process

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Fig. 1-4-7 White blood cell classification dilution process

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(4)C-reactive protein dilution process

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Fig. 1-4-8 C-reactive protein dilution process

1.4.3 White blood cell measurement CO

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
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figure below:
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Fig. 1-4-9 Flow cell

After a certain amount of blood cell is aspirated and reacts with a certain amount of reagent, 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. 1-4-10 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-6900CRP has one DIFF scattergram, which is obtained from low-angle forward scattered light and
middle-angle forward scattered light.
BF-6960CRP has three DIFF scattergrams, which are obtained from low-angle forward scattered light,

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middle-angle forward scattered light and high-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
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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. 1-4-11 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. 1-4-12 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 C-reactive protein measurement

1.4.6.1 Latex immunoturbidimetric assay
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BF-CRP lyse mixes with whole-blood sample to treat hemocyte and remove the disturbance of cell particles in
blood to immunoturbidimetric test. The C-reactive protein reagent mixes with the sample after hemolysis and the
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antibody labeling latex microsphere in C-reactive protein reagent has agglutination reaction with the C-reactive
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protein in sample. As a result, the turbidity of the solution increases and the concentration of C-reactive protein can
be obtained through immunoturbidimetry.
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1.4.6.2 C-reactive protein concentration parameters

The concentration of C-reactive protein (CRP) in whole-blood sample serum can be calculated with the formula
below, with unit as mg/L.
FR-CRP=CRP’/(1-HCT)
FR-CRP is the CRP concentration after correction;
CRP’ is the CRP concentration before correction;
HCT is hematokrit.
1.4.7 Rinsing
The Analyzer will rinse the components where sample flows automatically in each counting period to ensure no
sample left in liquid path.
(1)The internal and external sides of the sampling probe are rinsed with BF-5D diluent.
(2)The count cell is rinsed with BF-5D diluent.
(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).
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

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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

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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

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:
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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
bio-infectivity

LASER, DANGER SYMBOL

ALTERNATING CURRENT

IN VITRO DIAGNOSTIC MEDICAL DEVICE

BATCH CODE

USE BY

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Symbols Meaning

SERIAL NUMBER

DATE OF MANUFACTURE

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

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CATALOGUE NUMBER

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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
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

Atmospheric pressure limitation

Caution, hot surface

USB

network interface

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

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 51kg at least.
Remarks: Weight of host: 43kg; 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: 260VA.
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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

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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 CO
(1)Use transport machine such as utility trolley for the stable transportation of short distance.
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(2)Prevent the aspiration probe from other objects and being damaged during handling and transportation processes.
(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
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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
(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
remove the probe fastener, as shown in the figure:

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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
the cross recessed pan head combination screwfor fixing the isolation sleeve.
Remove theisolation sleeve; then screw down the two cross recessed pan head combination screws that fix the

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fastener and remove the fastener, as shown in the following figure:

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Fig. 2-2-6
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(5)Re-install the right door of the instrument.

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- FDOⅠ lyse port 2 BF-FDTⅠ lyse port 3 BF-CRP lyse port
4 BF-FBH lyse port 5 C-reactive protein reagent 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 lyse,
BF-CRP lyse and C-reactive protein reagent inside 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

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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
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.

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● 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.

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(5)Connection of bar code reader
Connect another end of accompanying bar code reader with any "
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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
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Analyzer is working.
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(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.

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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

Operating environment requirements: ARM
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).

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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,
and the initial password is 1, if a wrong user name and password are input, login failure will appear, and the
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interface is as shown in the figure below:

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Fig. 2-4-2

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

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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 and CRP quality control.
Maint.: Check the status of the instrument and have maintenance and check of the instrument.

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Settings: Set parameters of the instrument.

Log: Record system operating information and error information.
Reagent: reagent registration and reagent information settings.
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.

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2.4.2.3 Status indication area

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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,

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U disk connection status, LIS system connection status, and printer status, described as follows:
(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.

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(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.

(4)Printer status:

: The printer is connected.

: 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.

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(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.
(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
After clicking relevant failure information, the detailed solution to the failure will be displayed in the "Alarm help"
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and the user can have simple troubleshooting according the solution.
2.4.2.5 Info prompt area
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Interface location Prompt Auto-rinse times

Fig. 2-4-8
(1)Interface location: display the current interface.
(2)Prompt message: instrument abnormal info display area.
(3)Auto-rinse times: whether the instruments reaches the number of times for rinse.
When the instrument has abnormal info, it will be displayed in the area. Click the prompt message and the following
prompt will pop up:

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2.5 Gas & liquid path diagrams
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Fig. 2-5-1

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Fig. 2-5-3

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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 5 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.
“CBC+CRP”: on the basis of the “CBC” mode, the CRP parameters of the sample are analyzed at the same time.

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“CBC+DIFF+CRP” mode: it analyzes the CRP parameter of sample on the basis of “CBC+DIFF” mode.
“CRP” mode: it only analyzes the CRP parameter of sample.
(5)Tube number and rack number: If the [Auto-WB] mode is selected and [Auto-identify] is not selected, the [Rack
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 no barcode reader is 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:

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Table 3-3-1

Parameters Unit Numeric form Remarks

109/L ***.** Default unit

103/μL ***.**
WBC
2
10 /μL ****.*

/nL ***.**

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 **.**

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g/L *** Default unit

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HGB g/dL **.*

mmol/L **.*

fL
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***.* Default unit
MCV, RDW-SD
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μm3 ***.*
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pg **.* Default unit

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MCH
fmol ***
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g/L *** Default unit

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MCHC g/dL ***.*

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mmol/L ***.*

RDW-CV % **.* Default unit

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

109/L **** Default unit

103/μL ****
PLT, P-LCC
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10 /μL ***.*

/nL ****

fL **.* Default unit

MPV
μm3 ***.*

PDW fL **.* Default unit

% .*** Default unit

PCT
mL/L *.**

P-LCR % **.* Default unit

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Parameters Unit Numeric form Remarks

FR-CRP mg/L **.* Default unit

HS-CRP mg/L **.* 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.
Click [Menu] - [Settings] - [Reference value], as shown in Fig. 3-4-1:

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Fig. 3-4-1
Input of reference value lower and upper limits:
Click the corresponding input box of lower and upper limits following each test item and directly input the lower
and upper limits of corresponding test item.
After the limits are input, press [Save] for confirmation. When a prompt information of "Saved successfully" pops
up, click [OK] on the interface to save.
Click [DEF] to restore the default lower and upper reference values.

3.5 Abnormity flags setting

Click [Menu] - [Settings] - [Abno.flag] and select [WBC], as shown in the figure below:

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Fig. 3-5-1
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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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3.6.5 CRP setting

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Select [CRP], as shown in the figure below:

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Fig. 3-6-5
In the figure above, users can select the CRP 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
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.

3.7 Information setting

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

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Fig. 3-7-1
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(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.

● The user settings are only available to administrators.

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● 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:

Fig. 3-8-3
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
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.

The new password entered twice must be the same.

(4)Reset password: In Fig. 3-8-1, select the row of the user information that you want to reset your password, and
click [Reset PWD] to pop up the following prompt:

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Fig. 3-8-5
Click [OK] to reset the password. After the reset is successful, the new password is the same as the user name.

3.9 Instrument setting

3.9.1 Sleep setting
Click [Menu] - [Settings] - [Machine] and select [Sleep], as shown in the figure below:

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Fig. 3-9-1
After [Time], you can set the instrument sleep time in [60,120] minutes.
3.9.2 Automatic rinsing setting
Click [Menu] - [Settings] - [Machine] and select [Auto-rinse], as shown in the figure below:

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Fig. 3-9-2
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Input the number of automatic rinsing intervals 10-200 in the input box following "Count number" under Auto-rinse
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times.
Input the number of automatic rinsing intervals 1000-5000 in the input box following "Count number" under
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Number of automatic cleaning of WBC filter.

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3.9.3 Blocked hole setting

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Click [Menu] - [Settings] - [Machine] and select [Blocked hole], as shown in the figure below:
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Fig. 3-9-3

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Set if re-test is required after hole blockage and if hole blockage data is to be transmitted. After the setting
completion, click [Save] at the lower right corner. When the message “Saved successfully” is prompted, click [OK].
3.9.4 Other
Click [Menu] - [Settings] - [Machine] and select [Other], as shown in the figure below:

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Fig. 3-9-4
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Select whether to support 1.5mL centrifuge tube from the pull-down menu. The default is Not Support.
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3.10 Software setting

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3.10.1 Date format setting

Click [Menu] - [Settings] - [Software] - [Date format] and the interface is as shown in the figure below:
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Fig. 3-10-1
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The date display format includes the following three types:
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yyyy-MM-dd, dd-MM-yyyy and MM-dd-yyyy; select a common date format; after that, click [Save]; when "Saved
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successfully" is prompted, click [OK].

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When the time is modified, it is synchronized directly for saving without requiring clicking [Save].
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The changed date format will be displayed at all the time display positions (such as sending time and
sampling time).
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3.10.2 Print settings

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Click [Menu] - [Settings] - [Software] - [Print] and the interface is as shown in the figure below:
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Fig. 3-10-2
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(1)Auto print: select "Yes" or "No" to decide whether to automatically print the report when the test results are
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returned.
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(2)Printer: select the model of connected external printer from the pull-down menu.
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(3)Printing template: select the printing template from the pull-down menu: "Horizontal version" or "Vertical
version";
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(4)Print pictures: select "Yes" or "No" from the pull-down menu to decide whether to print the histogram.
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(5)Print format: select a piece of appropriate paper from the pull-down menu.
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(6)Title: edit the header on the print report sheet.

After the input is completed, click [Save] at the lower right corner. When the message “Saved successfully” is
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prompted, click [OK].

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3.10.3 Network settings

Click [Menu] - [Settings] - [Software] - [Network] and the interface is as shown in the figure below:
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Fig. 3-10-3
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After the setting of the IP and port of the LIS system and the IP and subnet mask of the equipment network is
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completed, click [Save]. When the message “Saved successfully” is prompted, click [OK].
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LIS connection: after the network is set, connect the LIS server.
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3.10.4 Language settings

Click [Menu] - [Settings] - [Software] - [Language] and the interface is as shown in the figure below:
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Fig. 3-10-4

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After selecting the corresponding language category and clicking [Save], the message “Saved successfully and the
instrument will restart” will pop up on the screen. After clicking [OK], the software will restart and the language
will be switched successfully.

When the instrument has an alarm, switching languages is not allowed.

3.10.5 Other setting
Click [Menu] - [Settings] - [Software] - [Other] and the interface is as shown in the figure below:

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Fig. 3-10-5
Start sample number: the initial sample number to test each time after start.
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Abnormal value icon setting: The user can select high and low value flags, including the use of "H, L" and "↑, ↓".
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After clicking [Save], when the message “Saved successfully” is prompted, click [OK].
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3.11 CRP settings

Click [Menu]-[Settings]-[CRP], and the interface is as shown below:

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Fig. 3-11-1
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HS-CRP: whether to test hypersensitive CRP; the default is off, not to test.
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CRP calibration: input the corresponding value in the “Sensitivity check value” input box; the input range is
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0~999999.
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“Sensitivity check value” is used in the CRP multi-point calibration sensitivity check. For details refer to 4.8.
After clicking [Save], when “Saving succeeded” is prompted, click [OK].
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Click [DEF] to restore to the corresponding initial value.

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Chapter 4 Calibration

4.1 Overview
The instrument is calibrated to ensure the accuracy of analysis result. The instrument must be calibrated before the
measured data can be used as valid data.

4.2 Calibration frequency

The instrument has been calibrated before the delivery. In the following three cases, the operator still needs to
calibrate the instrument:
(1)Before the instrument is used for the first time.
(2)After main parts are replaced.
(3)Obvious deviation is found in the system when QC is operated.

If the calibration fails, check whether the input parameters, calibrator used and reagents are correct, or
operate according to the alarm message and relevant prompts.

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4.3 Calibration method

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The instrument has three calibration modes: manual calibration, calibrator calibration and fresh blood calibration.
In calibrator calibration and fresh blood calibration, all calibration-related math calculations are performed
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automatically by the instrument. The calibration coefficient obtained after the calibration is saved on the “Manual”
interface.
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Preparation before calibration: check according to the following steps before the calibration. In case of any problem,
do not perform calibration. Contact the After-sales Service Department of the manufacturer of agent.
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(1)Check the instrument and reagent to ensure that the reagent volume is sufficient to complete the whole calibration
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process. If the reagent is used up during the calibration, re-calibration is required.

(2)The calibrator and reagent designated by the manufacturer shall be used in accordance with the user manual for
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calibrators and reagents.

4.4 Calibrator calibration

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Click [Menu] - [Calibration] - [Calibrator], as shown in the figure below:

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Fig. 4-4-1
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4.4.1 Input of calibrator reference value
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Click the "Ref." under each item, directly input the reference value of each parameter (refer to the user manual for
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calibrators for details).

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4.4.2 Calibration counting

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(1)Put a calibrator test tube:

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a)If the instrument has a sample feeder, put a test tube with mixed calibrator into the STAT chamber.
b)If the instrument does not have a sample feeder, put the test tube with mixed calibrator below the sampling
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probe to ensure the sampling probe can aspirate the calibrator.

(2)Press "Count" on the instrument to start calibration test. Then interface will be locked and the user cannot go to
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other operating interfaces. The test status of current calibration will be displayed in the status column at the bottom.
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(3)After the test is completed, the interface is unlocked and the result is displayed in the test result list. The current
record is selected by default "√".
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If a certain parameter in the obtained count results exceeds the valid range, the prompt will be popped up as shown
in the figure below:

Fig. 4-4-2
The current calibration count results are not saved and the current record is not selected by default. Count the
calibration again to overwrite the result.
(4)When the calibration is not completed (the effective calibration count does not reach 5 times), the software will
prompt the user to switch to the other interface as shown below:

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Fig. 4-4-3
When the effective calibration count reaches 5 times, the instrument will automatically calculate the average Mean,
CV%, and the new calibration coefficient for all the calibration data selected by default “√” according to the
formula.
Operators can select some groups of data to calculate the calibration coefficients, but the calibration coefficients can
only be calculated after selecting at least 5 groups of data. Each time the operator click the check box “√” to select or
cancel the “√” data, the calibration coefficient is refreshed and displayed in time.

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Calibrate calibration is only performed in the whole blood mode.

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4.4.3 Save calibration coefficient

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Click [Save] in Fig. 4-4-1. The followings may occur:
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(1)When the effective calibration count does not reach 5 times, the prompt is as shown in the figure below:
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Fig. 4-4-4
(2)When the CV% value of a calibration parameter exceeds the repeatability index of the instrument, the prompt is
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as shown in the figure below:

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Fig. 4-4-5
(3)When the new calibration coefficient of a certain parameter is not between 75% and 125%, the prompt is as
shown in the figure below:

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Fig. 4-4-6
In cases 2 and 3, the operator needs to check whether the input reference value is correct and start calibration
counting again.
(4)If the calculated calibration coefficients are all between 75% and 125%, and the CV% values of all the calibration
parameters do not exceed the repeatability index of the instrument, the prompts are as shown in the figure below:

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Fig. 4-4-7
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Click [OK], and the calibration coefficient will be automatically saved as the calibration coefficient on the
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“Manual” interface, as shown in the figure below.

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Fig. 4-4-8

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4.5 Fresh blood calibration

4.5.1 Preparation of fresh blood
(1)Use EDTA- K2 (1.5mg/mL~2.2mg/mL blood) anticoagulant vacuum blood collecting tube to collect venous
blood sample.
(2)Quickly and fully mix the venous blood and anticoagulant in the tube.
(3)Prepare 3 ~ 5 portions of normal fresh blood according to the above method.
(4)Take fresh blood samples of normal people, and complete the test within 2 hours so as not to affect the test results
for too long.
4.5.2 Calibration count
Click [Menu] - [Calibration] - [Fresh blood] as shown in the figure below:

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Fig. 4-5-1
(1)Select the analysis mode for whole blood or pre-dilution.
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(2)Select the number at the "Sample ID" before each test of fresh blood samples.
(3)Put a test tube:
a)If the instrument has a sample feeder, put a test tube with mixed fresh blood into the STAT chamber.
b)If the instrument does not have a sample feeder, put the test tube with mixed fresh blood below the sampling
probe to ensure the sampling probe can aspirate the calibrator.
(4)Press "Count" on the instrument to start calibration test. Then interface will be locked and the user cannot go to
other operating interfaces. The test status of current calibration will be displayed in the status column at the bottom.
(5)After the test is completed, the interface is unlocked and the result is displayed in the test result list. The current
record is selected by default "√".
If a certain parameter in the obtained count results exceeds the valid range, the prompt will pop up as shown in the
figure below:

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Fig. 4-5-2
The current calibration count results are not saved and the current record is not selected by default. Count the
calibration again to overwrite the result.
(6)When the effective calibration count of each portion of fresh blood reaches 5 times, the instrument will
automatically calculate the average Mean, CV%, and the new calibration coefficient for all the calibration data
selected by default "√" according to the formula. Operators can select some groups of data to calculate the
calibration coefficients, but the calibration coefficients can only be calculated after selecting at least 5 groups of data.
Each time the operator click the check box "√" to select or cancel the "√" data, the calibration coefficient is refreshed
and displayed in time.

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(7)If the calibration coefficients calculated of the current number of fresh blood samples are between 75% and 125%,

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and the CV% values of all calibration parameters do not exceed the repeatability index of the instrument. Select the
"Sample number" again and test the remaining fresh blood samples.

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4.5.3 Save calibration coefficient
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After the instrument has tested 3 or more fresh blood samples and obtained valid calibration coefficients, click
[Calculate Coef.] to display the content as shown in the figure below:
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Fig. 4-5-3
When less than 3 portions are selected, the average calibration coefficient will not be calculated. When 3 or more
portions are selected, the average calibration coefficient will be automatically calculated. Click [Save] to save the
current calibration coefficient.
When there are less than 3 portions of fresh blood for test, click [Calculate Coef.] and a prompt as shown in Fig.
4-5-4 will appear:

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Fig. 4-5-4
After selecting the calibration coefficient of more than 3 fresh blood samples, click [Save] to pop up the dialog box
as shown in the figure below:

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Fig. 4-5-5

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Click [OK], and the calibration coefficient will be automatically saved as the calibration coefficient on the "Manual"
interface.

4.6 Manual calibration

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After calibrator calibration or fresh blood calibration is executed and correctly saved, the obtained calibration
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coefficient is saved on the "Manual" interface.

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Click [Menu] - [Calibration] - [Manual], as shown in the figure below:

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Fig. 4-6-1

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When fine adjustment of calibration coefficient is required, click the corresponding row of each item under
[Cal.Coef.], directly input the calibration coefficient and click [Save]. When a dialog box of "Saved successfully"
pops up on the screen, click [OK].

4.7 CRP 2-point calibration

(1)Go to the [Calibration] menu, click [CRP 2-point], and the interface below will appear:

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Fig. 4-7-1
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(2)Prepare two concentrations of calibrators and enter the corresponding reference values in the "Ref." edit boxes of
the calibrators.
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(3)Aspirate calibrator:
a)If the instrument is equipped with a sample feeder, put the prepared first concentration calibrator into the
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emergency chamber, click the "Count" button on the sample feeder, and the instrument automatically performs
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calibration count 4 times.

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b)If the instrument is not equipped with a sample feeder, place the prepared first concentration calibrator under
the aspiration probe so that the aspiration probe can aspirate the calibrator. Click the "Count" button to perform
calibration count 4 times.
(4)After the counting process of the first concentration calibrator is completed, the second concentration calibrator
calibration count is performed according to step (3).
After the second concentration calibrator is counted, the system prompts "Scaling successfully" to save and display
the new calibration curve.

Fig. 4-7-2

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(5)If automatic calibration is not completed, the display is as shown below when the interface is switched:

Fig. 4-7-3
Click "OK" to exit CRP 2-point calibration and relevant data will not be saved.

● If the instrument is equipped with a sample feeder, a tube adapter is required for calibration.
● Each calibrator must be counted in order from lowest to highest concentration.
● When executing CRP two-point calibration, blank concentration and a concentration calibrator can be

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used, or two concentrations of calibrators other than blank can be selected.

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● If the calibrator count results do not increase progressively with concentrations, the system prompts "The
current calibration data is invalid"; and the calibration operation should be performed again.

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4.8 CRP multi-point calibration CO
(1)Go to the [Calibration] menu, click [CRP multiple-point calibration], and the interface below will appear:
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Fig. 4-8-1
(2)Prepare calibrators of five concentrations according to the user manual for calibrators, and successively input the
reference value for each calibrator in the order from low concentration to high concentration in the "Ref." edit box of
the calibrator.
a)If the instrument is equipped with a sample feeder, click the "Count" button on the sample feeder, and the
instrument will automatically perform blank count 4 times.

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b)If the instrument is equipped with a sample feeder, click the "Count" button to perform blank count 4 times.
(3)After the blank count is completed, prepare the calibrators according to the order of the calibrator concentration
from low to high, and perform calibration counting:
a)If the instrument is equipped with a sample feeder, put the prepared calibrator into the emergency chamber,
click the "Count" button on the sample feeder, and the instrument automatically performs calibration count 4
times.
b)If the instrument is not equipped with a sample feeder, place the prepared calibrator under the aspirating probe
so that the aspirating probe can aspirate the calibrator. Click the "Count" button to perform calibration count 4
times.
(4)The prepared calibrators are used for calibration count in order of concentration from low to high according to
step (3).
After the counting process of the highest concentration calibrator is completed, the system prompts "Scaling
successfully" to save and display the new calibration curve.

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Fig. 4-8-2
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(5)If automatic calibration is not completed, the display is as shown below when the interface is switched:
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Fig. 4-8-3
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Click "OK" to exit automatic calibration and relevant data will not be saved.
(6)If the difference in reactivity between the highest concentration calibrator and the blank concentration calibrator
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is less than the set value of the instrument sensitivity check, the display is as shown:

Fig. 4-8-4
Click [Yes] to save the current calibration curve; click [Cancel], the current calibration curve is not saved.

● If the instrument is equipped with a sample feeder, a tube adapter is required for calibration.
● Each calibrator must be counted in order from lowest to highest concentration.

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● If the calibrator count results do not increase progressively with concentrations, the system prompts "The
current calibration data is invalid"; and the calibration operation should be performed again.

4.9 CRP blank correction

When the instrument CRP blank counting result is abnormal, it is suggested to conduct CRP blank correction.
(1)Go to the [Calibration] menu, click [CRP blank], and the interface below will appear:

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Fig. 4-9-1
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(2)Blank counting
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a)If the instrument has a sample feeder, click Count on the sample feeder and the instrument will automatically
execute blank counting for 4 times.
b)If the instrument does not have a sample feeder, click "Count" and execute blank counting for 4 times.
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(3)After the blank counting is completed, a prompt of "Scaling successfully" is given by the system and the new
calibration curve is saved.
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Fig. 4-9-2
(4)If automatic calibration is not completed, the display is as shown below when the interface is switched:

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Fig. 4-9-3
Click "OK" to exit CRP blank calibration and relevant data will not be saved.

4.10 CRP manual calibration

After CRP single-point calibration, CRP multi-point calibration or CRP blank correction is executed and correctly
saved, the obtained calibration coefficient is saved on the "CRP manual calibration" interface.
Go to the [Calibration] menu, click [CRP manual], and the interface below will appear:

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Fig. 4-10-1
When fine adjustment of calibration coefficient is required, click the corresponding line of each item under
[Concentration] or [Reaction degree] and directly input the value. Click [Save] to save the data successfully.

4.11 Calibration history

The software records each piece of calibration information for the user to view.
Go to [Calibration], click [Calibration history], and the interface below will appear:

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Fig. 4-11-1
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The calibration date, calibration person, calibration method and calibration mode are displayed in the order of the
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list.
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Condition query: the operator can also screen calibration history according to the calibration method.
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Click to flip up and down.

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User Manual

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 User Manual

Chapter 5 QC

5.1 Overview
There may be a certain degree of error in the long-term use of the instrument, and the existence of error is likely to
lead to incorrect or unreliable analysis results. The quality control program provides an effective method of
detecting possible errors, and the quality control test allows the operator to test the accuracy and precision of daily
sample analysis results.
To ensure the reliability of the sample analysis results, it is suggested that the operators conduct quality control on
each instrument once with QC materials at low, middle and high levels respectively.
The instrument must be properly calibrated to perform a quality control test.
The instrument provides five quality control methods, i.e. L-J QC, QC, Xbar QC, X-B floating mean method QC,
X-R QC and CRP QC.

● The user must use the QC materials specified by the manufacturer, otherwise it will lead to inaccurate QC
results.

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● The use of QC materials is detailed in its instructions.

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● If a quality control test is conducted in the event of an instrument failure, the results obtained are

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unreliable.
● If QC is out of control, check if the input parameters, QC products used and reagents are correct, or
operate according to the alarm message and relevant prompts. CO
5.2 L-J QC
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Operators can conduct QC for 24 parameters under L-J QC. The instrument provides 12 QC files in total to save QC
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parameters and results. Each QC file can automatically save up to 31 groups of QC results. When QC is conducted
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for more than 31 times, the new QC results will overwrite the previous results.
Click [Menu] - [Q.C.] - [L-J], as shown in the figure below:
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Fig. 5-2-1

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5.2.1 Setting
5.2.1.1 Lot number information setting
Click [Setting], as shown in the figure below:

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Fig. 5-2-2
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(1)Selection of file No.:

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Click the file number pull-down menu and select the file to be conducted with QC whose range is 1~12.
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(2)Input of QC lot No.:

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Input the lot number of the corresponding QC product in the input box according to the User Manual of QC blood.
(3)Life setting:
Input the life of QC product in the input box according to the User Manual of QC.
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(4)Selection of QC level:
Click the pull-down menu and select a QC level (including high, medium and low levels), and every QC lot number
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corresponds to one level.

(5)Input of target value and deviation limit:
Input the corresponding target value and deviation limit according to QC manual.
After finishing all inputs above, click [Save] to pop up the "Saved successfully" information, and click [OK].

Lot number and life input shall conform to those noted in the user manual.
5.2.1.2 Take preset value
Click [Use DEF] to input the reference value and deviation limit at corresponding level saved in the system into the
current QC file.
If the reference value and deviation limit at corresponding level are not saved in the system, click [Use DEF] and
then a prompt dialog box below will pop up.

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Fig. 5-2-3
After taking the preset value is finished, click [Save] to pop up the "Saved successfully" information, and click
[OK].
5.2.2 QC count
Click [QC count] in Fig. 5-2-2 and display will be as shown below:

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Fig. 5-2-4
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(1)QC counting
a)If the instrument has a sample feeder, place the test tube with mixed QC object in the STAT chamber and click
Count, then the instrument will start QC counting and analysis. Meanwhile, display the QC test status
successively in the operating status column at the bottom of the interface.
b)If the instrument does not have a sample feeder, place the test tube with mixed QC object below the sampling
probe to make the sampling probe aspirate the sample, then click Count and the instrument will start QC counting
and analysis. Meanwhile, display the QC test status successively in the operating status column at the bottom of
the interface.
(2)After the analysis, the counting results will be displayed on the screen, as shown in the figure below:

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Fig. 5-2-5
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(3)Printing of QC data
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Click [Print] to print the current record if single QC result needs to be printed.
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5.2.3 QC diagram
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Click [QC diagram] in Fig. 5-2-5 and display will be as shown below:
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Fig. 5-2-6
(1)QC diagram query: select to view item data.

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(2)Description of QC graph interface:

a)If the number of the QC count is less than 3, QC result of each parameter will not be displayed on the right of
QC graph.
b)No target value or deviation limit is set. The QC diagram does not show the QC results.
c)The X-axis of QC diagram shows the number of QC count results in QC file, while the Y-axis shows QC count
result of each parameter.
d)Vertical bar is used to mark the count data of the same group, and at most 31 points can be displayed in the QC
diagram for each parameter.
e)As for each parameter, these three data on the left of the QC diagram correspond to three boundary values,
representing respectively, from top to bottom, the upper limit, target value and lower limit of the parameter:
Upper limit: QC material reference value + deviation limit
Target: reference value of QC material
Lower limit: QC material reference value - deviation limit
f)As for each parameter, the three data on the left of QC diagram respectively represent Mean (mean), SD
(standard deviation) and CV% (coefficient of variation).
(3)Descriptions of points in QC diagram:

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a)Each point in QC chart corresponds to a QC result and the points are connected by line sections.

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b)"Green solid circle" means that the QC result is under control, while "Red hollow circle" means that the QC

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result is out of control.
(4)If points in the QC diagram are beyond the QC range, deal with them in accordance with the steps below:
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a)Check whether the target value and deviation limit of QC material are correct.
b)Whether the background test of the instrument is normal.
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c)If the above two points are all normal, calibrate the instrument and then perform QC and count.
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d)If the instrument remains abnormal after calibration, please contact the after-sales service department of
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manufacturer or agent.
(5)Print QC diagram:
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Click [Print] to print according to the preset template of QC diagram.

Correctly connect the printer, and click [Print] in the figure above to print the report needed.
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(6)Calculate preset value in QC diagram:

When 3 or more QC results exist in QC diagram, calculate and save preset values following the procedures below:
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Operator can calculate Mean (mean), SD (standard deviation) and CV% (coefficient of variation) in QC diagram
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which serve as preset values in QC editing.

(7)Setting of deviation limit:
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Please refer to 3.6 QC setting for details.

(8)Remove the abnormal QC point:
If abnormal QC point exists in a QC diagram, remove it and then take the preset value following the operation
procedures below:
a)Click [Calc. DEF] in Fig. 5-2-6, as shown below:

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Fig. 5-2-7
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b)Click the selected abnormal QC point and the red cursor line will stop on the abnormal QC point. Click [Delete]
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and the selected abnormal QC point will change to "black point". When the preset value is taken for calculation,
the removed QC point (black QC point) is not included.
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c)After removing the invalid point, click [Save DEF] and the instrument will save the preset value which can be
used to calculate current level into the system.
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d)If there are less than 3 valid QC points, click [Save DEF], and a prompt box will pop up on the interface as
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shown in the figure below:

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Fig. 5-2-8
If the operation above has error, click the screen to move the red cursor line to the removed point, and black QC
point will turn to be red or green through clicking [Add], then the removed point will recover to normal.

When calculating preset value, adopt data of valid QC point as reference value and deviation limit.
5.2.4 QC list
Users can select different QC files to browse QC data.
Click [QC list] and select the QC file number to be queried from the pull-down menu of [File No.], as shown in the
figure below:

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Fig. 5-2-9
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(1)Delete all: the operator can delete all QC counting results in the current QC file.
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Click [Delete all] to pop up the prompt box as shown below:

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Fig. 5-2-10
Click [OK] to delete all the data.
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(2)Delete: the operator can delete a QC counting result in the current QC file.
Select the QC data to be deleted and click [Delete] to pop up the prompt box as shown in the figure below:

Fig. 5-2-11
Click [OK] to delete the selected data.
(3)LIS transmission: when connecting LIS, operators can transmit the QC results in the current QC file to the LIS
software.

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(4)View data: select to view item data through page up and down; click
to view item data through page left and right.

5.3 Xbar QC
Xbar QC: adopt the mean of two measurement results as a QC point to be saved in the QC diagram.
Other operations are the same as "5.2 L-J QC".

5.4 X-B QC
X-B floating mean method is put forward by Dr. BrianBull. Through stability of red blood cell parameters such as
MCV, MCH and MCHC, the monitoring and control of instrument performance can be achieved. It is a QC method
without QC object and mainly to monitor the instrument performance like quality control of QC object. The two
methods reflect the analysis performance of the instrument from different aspects, but they cannot replace each
other. X-B QC is recommended when the daily sample volume of the instrument is larger than 100. Accompanying
sample is required to be used in the QC method which, as a result, cannot be used for sample classified according to
disease types. Its reference range is composed of given reference value and upper and lower limit. Observe the
change trend of QC result within the reference range.
The instrument conducts X-B QC to three parameters: MCV, MCH and MCHC, and 20-200 samples can be tested

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in X-B value analysis for each group which come from the result of normal counting without distinguishing

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whole-blood from pre-dilution mode.

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As the X-B QC reference value is worked out after statistics and analysis of a large amount of accompanying
samples, the instrument shall be calibrated before test.
5.4.1 Setting CO
Before X-B QC, QC parameter shall be set.
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Click [Menu] - [Q.C.] - [X-B], as shown in the figure below:

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Fig. 5-4-1
Input target value and deviation limit: click the table of corresponding target value and deviation limit of parameters
to input.
Target value: as the reference value differs from region to region, sample quantity is required to reach a certain
number (more than 150 is recommended), then the arithmetic mean value of these samples is selected as the target

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value of X-B QC.

Deviation limit: 3%~5% of target value shall be used as corresponding deviation limit.

Target value and deviation limit shall not be null.

After finishing the setting, click [Save] to pop up the "Saved successfully" information, and click [OK].
5.4.2 QC diagram
Click [QC diagram], as shown in the figure below:

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Fig. 5-4-2
(1)Descriptions of QC graph:
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The X-axis of QC diagram shows the number of QC count result in QC file, while the Y-axis shows QC count result
of each parameter.
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As for every parameter, the three data on the left of the QC diagram correspond to three boundaries, representing
respectively, from top to bottom, the upper limit, target value and lower limit of the parameter.
Upper limit: QC material reference value + deviation limit
Target: reference value of QC material
Lower limit: QC material reference value - deviation limit
As for each parameter, the three data on the left of QC graph respectively represent Mean (mean), SD (standard
deviation) and CV% (coefficient of variation).
(2)Descriptions of points in QC diagram:
Each point in QC diagram corresponds to a QC result and the points are connected by line sections.
"Green solid circle" means that the QC result is under control, while "Red hollow circle" means that the QC result is
out of control.
(3)If points in the QC diagram are out of the QC range, dispose following the procedures below:
a)Check whether the target value and deviation limit are correct.
b)Whether the background test of the instrument is normal.
c)If the instrument remains abnormal after calibration, please contact the after-sales service department of

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manufacturer or agent.
5.4.3 QC list
Click [QC list], as shown in the figure below:

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Fig. 5-4-3
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(1)Delete: click QC data following the corresponding number to display the selection status in the row, and click
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[Delete], as shown in the figure below:

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Fig. 5-4-4
Click [OK] and the prompt information "Deleted successfully" will pop up on the interface which means that
selected records are successfully deleted.

Target value and deviation limit shall not be deleted.

(2)Delete all: click [Delete all] as shown in the figure:

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Fig. 5-4-5
Click [OK] to delete all the records.
(3)Check the data: select , check the item data through page turning.
(4)LIS transmission: click [Transmit LIS] to transfer the data to the LIS system connected with.

5.5 Xbar-R QC
Xbar QC diagram is mainly used to observe the changes of normally distributed mean, and R QC diagram is used to
observe the changes of dispersion or variation of normal distribution while Xbar-R QC diagram integrated with the

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two diagrams above is used to observe the changes of normal distribution.

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Xbar-R QC diagram reflects the differences between batches and days of day-to-day test, achieving the effective
monitoring and control of system factors during the test, thus it is applicable to laboratory with high-level

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automation and large inspection amount.
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Xbar-R QC: adopt the mean of two measurement results as a QC point saved in the mean QC diagram; adopt the
difference between two measurement results as a QC point saved in the range QC diagram. Every parameter is
displayed in the mean QC diagram and range QC diagram.
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Click [Menu] - [Q.C.] - [Xbar-R], as shown in the figure below:

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Fig. 5-5-1

5.5.1 Setting
Click [Setting], as shown in the figure below:

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Fig. 5-5-2
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(1)Selection of file No.:
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Select the QC files numbering 1~12 from the pull-down menu.

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(2)Input of QC lot No.:

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Input the lot number of the corresponding QC product in the input box according to the User Manual of QC blood.
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(3)Life setting:
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Input the life of QC product in the input box according to the User Manual of QC.
(4)Selection of QC level:
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Select the QC level (including high, medium and low levels) from the "Level" pull-down menu. Each QC lot
number corresponds to one level.
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After finishing the setting, click [Save] to pop up the "Saved successfully" information, and click [OK].
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Lot number and life input shall conform to those noted in the user manual.
5.5.2 QC count
Click [QC count], as shown in the figure below:

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Fig. 5-5-3
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(1)QC counting
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a)If the instrument has a sample feeder, place the test tube with mixed QC object in the STAT chamber and click
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Count, then the instrument will start QC counting and analysis. Meanwhile, display the QC test status
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successively in the operating status column at the bottom of the interface.

b)If the instrument does not have a sample feeder, place the test tube with mixed QC object below the sampling
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probe to make the sampling probe aspirate the sample, then click Count and the instrument will start QC counting
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and analysis. Meanwhile, display the QC test status successively in the operating status column at the bottom of
the interface.
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(2)After the analysis, the counting results will be displayed on the screen.
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Only when the result is 1, it is forbidden to switch the interface. If it is switched, the test result of result 1 will
not be saved.
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(3)After the analysis, the sample probe will reset and get prepared for next counting and the counting results will be
displayed on the screen, as shown in the figure below:

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Fig. 5-5-4
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If the counting result worked out is lower than the lower limit set in the instrument software, it will be displayed in
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blue, and if higher than the display range of the instrument, it will be displayed in red.
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(4)QC data modification

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The administrator's user rights can modify the test data.

After QC test, if results need to be modified, click the result to modify, then click [Save] to save the modified results.
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(5)Printing of QC data
Click [Print] to print the current record if a single QC result needs to be printed.
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5.5.3 QC diagram
Click [QC diagram], as shown in the figure below:
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Fig. 5-5-5
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(1)Relevant calculation description:
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a)Mean:
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a bcdef gh i j

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Xbar 
n
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Where:
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a~j refer to the mean of every two measurement results;

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n refers to the number of mean.

b)Range mean:
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Ra  Rb  Rc  Rd  Re  Rf  Rg  Rh  Ri  Rj
Rbar 
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n
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Where:
Ra~Rj refer to the range of every two measurement results;
n refers to the number of range.
(2)Description of QC diagram interface:
If the number of QC count is less than 3, QC result of each parameter will not be displayed on the right side of QC
diagram.
The X-axis of QC diagram shows the number of QC count result in QC file, while the Y-axis shows QC count result
of each parameter.
Vertical bar is used to mark the count data of the same group, and at most 31 points can be displayed in the QC
diagram for every parameter.
As for each parameter, these three data on the left of the QC diagram correspond to three boundary values,
representing respectively, from top to bottom, the upper limit, target and lower limit of the parameter.
QC diagram of every test item includes mean QC diagram and range QC diagram, take WBC for example, and the
display will be as shown below:
a)Mean diagram (WBC M part is displayed in the figure):

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Target of mean: CL  Xbar

Upper limit of mean: UCL  Xbar  1.88  Rbar (1.88 in the formula is a fixed value)
Lower limit of mean: LCL  Xbar  1.88  Rbar (1.88 in the formula is a fixed value)
b) Range diagram (WBC R part is displayed in the figure):
Target of range: CL  Rbar
Upper limit of range: UCL  3.27  Rbar (3.27 in the formula is a fixed value)
Lower limit of range: LCL  0
As for each parameter, the three data on the left of QC diagram respectively represent Mean (mean), SD (standard
deviation) and CV% (coefficient of variation).
(3)Descriptions of points in QC diagram:
Each point in QC diagram corresponds to a QC result and the points are connected by line sections.
"Green point" refers to the QC result is under control while "Red point" refers to the QC result is out of control.
(4)If points in the QC diagram are beyond the QC range, deal with them in accordance with the steps below:
a)Whether the background test of the instrument is normal.

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b)If the background test is normal, re-execute QC count, and if QC point remains abnormal in QC diagram,
conduct QC count after the calibration of instrument.

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c)If the instrument remains abnormal after calibration, please contact the After-sales Service Department of the
manufacturer.
5.5.4 QC list
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The user can select different QC files to browse QC data.
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Click [QC list] and select the QC file number to be queried from the [File No.] pull-down menu, as shown in the
figure below:
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Fig. 5-5-6
(1)Delete all: the operator can delete all QC counting results from the current QC file. Click [Delete all] in the figure
above, and then the screen is as shown below:

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Fig. 5-5-7
Click [OK] to delete all the data.
(2)Delete: the operator can delete a QC counting result from the current QC file.
Select the QC data to be deleted and click [Delete], as shown in the figure below:

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Click [OK] to delete the selected data.
Fig. 5-5-8 CO
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(3)LIS transmission: operators can transmit the selected QC counting results to the LIS system.
(4)Print: the operator can print the QC count result in the current QC file.
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(5)Check the data:

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Select to check the item data;

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Select to check the item data.

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5.6 CRP QC
Operators can conduct QC to CRP under CRP QC. 12 QC files are provided by the instrument to facilitate saving
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QC setting parameter and result. Each QC file can automatically save up to 31 groups of QC results. When QC is
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conducted for more than 31 times, the new QC results will overwrite the previous results.
Click [Menu] - [Q.C.] - [CRP], as shown in the figure below:
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Fig. 5-6-1
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5.6.1 Setting
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5.6.1.1 Lot number information setting

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Click [Setting], as shown in the figure below:

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Fig. 5-6-2
(1)Selection of file No.:
Select the QC files numbering 1~12 from the pull-down menu.

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(2)Input of QC lot No.:

Input the lot number of the corresponding QC product in the input box according to the User Manual of QC blood.
(3)Life setting:
Input the life of QC product in the input box according to the User Manual of QC.
(4)Selection of QC level:
Select QC level (including high and low level) from the pull-down menu, and every QC lot number corresponds to
one level.
(5)Input of target value and deviation limit:
Input the corresponding target value and deviation limit according to QC manual.
After finishing all inputs above, click [Save] to pop up the "Saved successfully" information, and click [OK].

Lot number and life input shall conform to those noted in the user manual.
5.6.1.2 Take preset value
Click [Use DEF] to input the reference value and deviation limit at corresponding level saved in the system into
current QC file.

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If the reference value and deviation limit at corresponding level are not saved in the system, click [Use DEF] and
then a prompt dialog box below will pop up.

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Fig. 5-6-3
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After taking the preset value is finished, click [Save] to pop up the "Saved successfully" information, and click
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[OK].
5.6.2 QC count
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Click "QC count" in Fig. 5-6-2 and display will be as shown below:
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Fig. 5-6-4
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(1)QC counting:
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a)If the instrument has a sample feeder, place the test tube with mixed QC object in the STAT chamber and click
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Count, then the instrument will start QC counting and analysis. Meanwhile, display the QC test status
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successively in the operating status column at the bottom of the interface.

b)If the instrument does not have a sample feeder, place the test tube with mixed QC object below the sampling
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probe to make the sampling probe aspirate the sample, then click Count and the instrument will start QC counting
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and analysis. Meanwhile, display the QC test status successively in the operating status column at the bottom of
the interface.
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If the instrument is equipped with a sample feeder, a tube adapter is required for QC count.
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(2)After the analysis, the counting results will be displayed on the screen, as shown in the figure below:
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Fig. 5-6-5
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(3)Printing of QC data
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Click [Print] to print the current record in the shortcut key area if a single QC result needs to be printed.
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5.6.3 QC diagram
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Click "QC diagram" in Fig. 5-6-5 and display will be as shown below:
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Fig. 5-6-6
(1)Description of QC diagram interface:

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a)If the number of the QC count is less than 3, QC result of each parameter will not be displayed on the right of
QC graph.
b)No target value or deviation limit is set. The QC diagram does not show the QC results.
c)The X-axis of QC diagram shows the number of QC count results in QC file, while the Y-axis shows QC count
result of each parameter.
d)Vertical bar is used to mark the count data of the same group, and at most 31 points can be displayed in the QC
diagram for each parameter.
e)As for parameter CRP, these three data on the left of the QC diagram correspond to three boundary values,
representing respectively, from top to bottom, the upper limit, target value and lower limit of the parameter.
Upper limit: QC material reference value + deviation limit
Target: reference value of QC material
Lower limit: QC material reference value - deviation limit
f)As parameter CRP, the three data on the left of QC diagram respectively represent Mean (mean), SD (standard
deviation) and CV% (coefficient of variation).
(2)Descriptions of points in QC diagram:
Each point in QC diagram corresponds to a QC result and the points are connected by line sections.

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"Green solid point" means that the QC result is under control, while "Red hollow point" means that the QC result is

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out of control.

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(3)If points in the QC diagram are out of the QC range, dispose following the procedures below:
a)Check whether the target value and deviation limit of QC material are correct.
b)Whether the background test of the instrument is normal.
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c)If these two points above are normal, re-execute QC counting, and if abnormal QC point remains in QC
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diagram, conduct QC counting after the calibration of instrument.

d)If the instrument remains abnormal after calibration, please contact the after-sales service department of
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manufacturer or agent.
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(5)Print QC diagram:
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Click [Print] to print according to the preset template of QC diagram.

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Correctly connect the printer, and click [Print] in the figure above to print the report.
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(6)Calculate preset value in QC diagram:

When 3 or more QC results exist in QC diagram, calculate and save preset values following the procedures below:
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Operators can calculate Mean (mean), SD (standard deviation) and CV% (coefficient of variation) in QC diagram
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which serve as preset values in QC editing.

(7)Setting of deviation limit:
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Please refer to 3.6 QC setting for details.

(8)Remove the abnormal QC point:
If abnormal QC point exists in a QC diagram, remove it and then take the preset value following the operation
procedures below:
Click lower right [Calc. DEF] in Fig. 5-6-6, as shown below:

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Fig. 5-6-7
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Click the selected abnormal QC point and the red cursor line will stop on the abnormal QC point. Click [Delete] and
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the selected abnormal QC point will change to "black point". When the preset value is taken for calculation, the
removed QC point (black QC point) is not included.
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After removing the invalid point, click [Save DEF] and the instrument will save the preset value which can be used
to calculate the current level into the system.
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If there are less than 3 valid QC points, click [Save DEF], and a prompt box will pop up on the interface as shown in
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the figure below:

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Fig. 5-6-8
If the operation above has error, click the screen to move the red cursor line to the removed point, and black QC
point will turn to be red or green through clicking [Add], then the removed point will recover to normal.

When calculating the preset value, adopt data of valid QC point as reference value and deviation limit.
5.6.4 QC list
The user can select different QC files to browse QC data.
Click [QC list] and select the QC file number to be queried from the pull-down menu of [File No.], as shown in the
figure below:

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Fig. 5-6-9
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(1)Delete all: operators can delete all QC counting results from the current QC file.
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Click [Delete All] to pop up the prompt box as shown below:

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Fig. 5-6-10
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Click [OK] to delete all the data.

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(2)Delete: the operator can delete a QC counting result from the current QC file.
Select the QC data to be deleted and click [Delete] to pop up the prompt box as shown in the figure below:

Fig. 5-6-11
Click [OK] to delete the selected data.
(3)LIS transmission: when connecting LIS, operators can transmit the QC results in the current QC file to the LIS
software.

(4)Check the data: select , check the item data through page turning.

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Chapter 6 Sample registration

6.1 Overview
The operator can input the information of the sample to be analyzed before the sample analysis and then click Use
worklist in mode setting and test the sample to be analyzed in sequence.
Click [Menu] - [Sample registration], as shown in the figure below:

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Fig. 6-1-1
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6.2 Edit information

Click [Add] to add a sample to be tested. Select the sample to be tested and click [Edit info], and the interface is
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shown the figure below:

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Fig. 6-2-1
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6.2.1 Sample information
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(1)Sample ID: Edit the sample number to be tested.

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(2)Bar code: The default is null and it can be input manually or by scanning.
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(3)Analysis mode: The newly added record defaults to the mode currently used by the instrument and cannot be
modified.
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(4)Test mode: select an appropriate test mode from the pull-down menu.
(5)Sending doc.: Select the doctor from the pull-down menu.
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(6)Case No.: Input the case number of a patient manually.

(7)Sampling time and sending time: The newly added record defaults to the current time, which can be directly
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changed. When changing it, note that the sampling time cannot be greater than the submission time, and neither can
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it exceed the current system time.

6.2.2 Patient information
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(1)Name: Input the name of the patient directly.

(2)Sex: The sex of patient includes male, female and?. Click the pull-down menu beside "Sex" to select one.
(3)Reference group: The reference ranges for test items include ordinary, adult male, adult female, child, newborn
and five custom reference ranges, totally 10 ranges for selection. Select from the pull-down menu.
(4)Age: Click the pull-down menu following "Age" and the interface shown in the figure below will pop up for
selection directly.

Fig. 6-2-2

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The reference group is linked with age and sex. After the sex is selected, age is input and age unit is selected, the
reference group will be selected automatically. For the newborn, it is smaller than or equal to 28 days. For children,
it is greater than 28 days but no greater than 13 years. For the ordinary, it is greater than 13 years. If it is greater than
13 years and the sex is male, it will be deemed adult male by default. If it is greater than 13 years and the sex is
female, it will be deemed adult female by default.
(5)Department: Select it from the pull-down menu directly.
(6)Cost type: Select the charge in the pull-down menu.
(7)Remark: user can input detected clinical diagnosis information (can be input directly).
After all the above said information is input, click [Save] to save them.

6.3 Download work list

Click [Download] in Fig. 6-1-1 to enter the interface as shown in the figure:

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Fig. 6-3-1
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Input the sample bar code manually or scan it, then Click [OK]. After it is downloaded successfully, the patient
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information will be recorded in work list and "Data back succeeded" will display below the bar code and the work
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list can be downloaded. The following abnormal situations may occur during download:
(1)When the bar code number is not input, the prompt box as shown in the figure below will pop up:
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Fig. 6-3-2
(2)When the LIS is not connected, the prompt box as shown in the figure below will pop up:

Fig. 6-3-3
(3)When the instrument has 200 work lists, the prompt box as shown in the figure below will pop up:

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Fig. 6-3-4
(4)When the bar code information and the LIS terminal do not match, the content shown in the figure below will
display:

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Fig. 6-3-5
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After finishing the download of work lists, click [Cancel] to exit the interface.
After the work list is downloaded, click [Cancel] to exit the interface.
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6.4 Delete work list

(1)Delete all: The operator can delete all QC counting results in the current QC file. Click [Delete all] in Fig. 6-3-1:
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Fig. 6-4-1
(2)Delete: the operator can delete a QC counting result in the current QC file.
In Fig. 6-3-1, select the work list to be deleted and then click [Delete], and the interface below will appear:

Fig. 6-4-2
Click [OK] to delete the selected work list.

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Chapter 7 Routine operation

7.1 Overview
This chapter introduces the whole regular operation process from startup to close of the instrument, which gives
specific instructions on the operation process of the whole-blood sample analysis and pre-dilution (peripheral blood)
sample analysis.
The daily operation process is shown as follows:

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Fig. 7-1-1

7.2 Preparation for operation

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Before turning on the power switch of the instrument, the operator shall conduct an inspection in accordance with
the following requirements to ensure the system prepared to work.
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(1)Inspection of waste liquid tank

Ensure the waste liquid tank empty before startup every day.
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(2)Liquid path inspection

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Check if the pipeline connected with the reagent and waste liquid tank is bent or twisted, and if the connection is
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reliable.

Please use matching reagent produced by Dirui Company. The Company will not be responsible for
inaccurate test results caused by failure to use matching reagent.
(3)Inspection of power source
Check if the power cable of the instrument is connected correctly.
(4)Inspection of printer
a)Check if the data cable of the printer is correctly connected to the instrument, and if the power cable is
connected correctly.
b)Check if the printing paper is sufficient, and if the installation is correct.
(5)Inspection of bar code reader
Check if the cable of the external bar code reader is correctly connected to the instrument.

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7.3 Turn-on
Turn on the power switch. The screen displays “System Loading...” and the instrument is initialized.

7.4 Daily QC

Before the sample analysis, a QC analysis of the instrument shall be conducted every day to ensure reliable
analysis results of the instrument. Refer to Chapter 6 for specific operation.

7.5 Sample preparation

● The operator shall use clean EDTA-K2 anticoagulation vacuum blood collecting tubes, silicified
glass/plastic test tubes and 20μL of silicon-boronized glass capillaries.
● Samples used for white blood cell classification or platelet count shall be saved under room temperature,
and shall be analyzed within 8 hours after collection.
● If analysis results of PLT, MCV or five classification of white blood cells are not needed, the samples can be

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saved in 2℃~8℃ of refrigerator for 24 hours. The refrigerated samples shall be placed under room

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temperature for at least 30 minutes before analysis.
● Emulsion reagent used for CRP measurement shall be saved in low-temperature ambient, with the saving

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condition of 2℃~8℃. If the room temperature is under 2℃, please take the reagent out of the instrument
and put it into the refrigerator to ensure it is saved under the temperature of 2℃~8℃.
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● Samples having been placed for a certain time shall be re-mixed before analyzing.
7.5.1 Test tube types
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Table 7-5-1 Supporting test tube types

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Position for Test Open Cap

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Mode Test Tube Type Adapter

Tube or Not
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Automatic Whole Vacuum Blood

Test Tube Rack No ×
Blood Collecting Tube
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Vacuum Blood
Emergency Position Both Ok ×
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Whole Blood Collecting Tube

1.5mL Centrifuge Tube Emergency Position Yes ×

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Micro-Whole Blood Micro-blood Test Tube Emergency Position Yes √

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Pre-dilution 1.5mL Centrifuge Tube Emergency Position Yes ×

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(1)Vacuum Blood Collection Tube

Diameter 12mm~14mm
Length ≥75mm
Including test tube cap length 80mm~83mm
Test tube cap diameter ≤Φ16mm

(2)Micro-blood test tube dimensions

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(3)1.5mL centrifuge tube dimensions

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● The dimensions do not include the cap. Open it before determination.

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● Please use the adapter for tests with a micro-blood test tube.
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7.5.2 Whole-blood sample

(1)Use a clean EDTA-K2 (1.5mg/mL~2.2mg/mL of blood) anticoagulation vacuum blood collecting tube to collect
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venous-blood sample, and ensure the collected sample volume over 1mL.
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(2)Quickly and fully mix the venous blood and anticoagulant in the tube.
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7.5.3 Peripheral blood sample

(1)Click [Dispense diluent] in the shortcut key area to pop up the prompt of "Prepare to dispense diluent", as shown
in the figure below:

Fig. 7-5-1
(2)Click [OK] and it will prompt "Preparing diluent..."
(3)After the diluent is prepared, a diluent dispensing interface will pop up, as shown in figure below:

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Fig. 7-5-2
(4)Dispense diluent
a)If the instrument has a sample feeder, take a clean centrifuge tube and put it in the STAT chamber as shown in
the figure, and then press the [Count] key. The instrument will push the STAT chamber to the position below the
sampling probe, the diluent will be dispensed to centrifuge tube automatically. After that, the chamber will get

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back to its original position and then the centrifuge tube can be removed.

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Fig. 7-5-3
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b)If the instrument does not have a sample feeder, put the centrifuge tube below the sampling probe and click
"Count" to start dispensing.
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Fig. 7-5-4
(5)After diluent dispensing is finished, collect 20μL of peripheral blood and quickly inject it along the centrifuge
tube wall into the tube filled with BF-5D diluent, and then mix them to finish a preparation process of a pre-dilution
sample.

● Operators can also use a pipette to dispense 180μL of diluent, and inject the collected 20μL of peripheral
blood along the centrifuge tube wall into the tube, and then mix them.
● Avoid dust mixing into the prepared diluent, or it will cause analysis error.

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● Fully mixed peripheral blood and diluent shall be placed for 3 minutes, and then be re-mixed for
analyzing.
● Ensure the diluted sample be analyzed within 30 minutes, or it will cause unreliable analysis results.
● Samples having been placed for a certain time shall be re-mixed before analyzing.
● Each laboratory shall conduct a stability assessment of the sample analysis result under pre-dilution mode
in accordance with the specific sample quantity, sampling method and technological level of each lab.

7.6 Whole-blood sample analysis

7.6.1 Sample analysis steps
Under the main interface, if the current mode is [WB], conduct the test directly. Or set the current mode as "Whole
blood" according to the following operation.

● Set the reference value range of the parameters on [Settings] interface before the test, or there may be an
alarm prompt of incorrect result after the test.
● Conduct the sample analysis directly after selecting work mode, and the defaulted reference range of the
instrument is "Normal". After the analysis, the alarm of the instrument is given in accordance with the

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reference value range of "Normal" setting.

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(1)Click [Mode] on the sample analysis interface, and the interface will pop up as shown below:

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Fig. 7-6-1

If no barcode reader is connected, the “Two-way LIS” option will not be displayed on the interface.
(2)Modification of analysis mode and sample number:
a)Analysis mode:
Under the analysis mode, select [WB] or [Micro-WB] mode. If it is a vacuum blood collecting tube, select [WB].
If it is a micro-blood test tube, select [Micro-WB]. After correct selection, click [Save] in Fig. 7-6-1, and the
operation mode will automatically switch to the [WB] mode.
b)Select mode under "Test mode":

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"CBC" mode: count only, with no classification of the white blood cells. The count result comprises histograms
of the RBC and PLT and 15 parameters.
"CBC+DIFF" mode: count, and classify the white blood cells. The count result comprises 25 parameters and
scattergrams and histograms.
“CBC+CRP” mode: count only, and not classify white blood cells. The count result comprises 17 parameters and
scattergrams and histograms.
"CBC+DIFF+CRP" mode: count, and classify the white blood cells. The count result comprises 27 parameters
and scattergrams and histograms.
"CRP" mode: Only count the CRP.
c)Select [Use work list] to test the sample record to be tested in the test work list.
d)Click [Save] to save the setting.

The upper limit of the input sample number is 12 bits, and "-" is valid, but "." is invalid.
(3)Sample test
a)If the instrument has a sample feeder, under the condition prepared for counting, shake the sample tube up and

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down gently to mix the sample, and then put the sample tube in STAT chamber and press "Count" to start test.

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After the test, the software will save the analysis results automatically and display the test results on screen. After
the sample is aspirated, the STAT chamber will get back to initial position to wait for the next test.

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Fig. 7-6-2
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b)If the instrument does not have a sample feeder, under the condition prepared for counting, shake the sample
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tube up and down gently to mix the sample, and then put the sample tube below the sampling probe and press
"Count" on front panel of the instrument to start test. After the test, the software will save the analysis results
automatically and display the test results on screen. After the sample is aspirated, the probe will return to the
initial position to wait for the next test.
(4)Place the next sample in the STAT chamber position and press "Count" to start the test.
(5)On the sample analysis interface, click "Print" in the shortcut key area to print the report; or select sample record
on query history interface, and click "Print" in the shortcut key area to print the reports of single-sample record or
multi-sample records.

● When the analysis mode is “Micro-WB”, a tube adapter is required for count.
● Disposable vacuum blood collecting tube can be used five times at most, since the fragments produced by
repeated puncturing may lead to inaccurate test results.
● Browsing of the graphs and viewing of the research parameters can be conducted in the analysis process,
but no operation can be performed; the data will be automatically saved in the sample analysis after
analyzing.

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● During analysis, if the aperture is plugged or behind the test data there is a"? ", the analysis results are not
reliable. Please conduct "Unblocking" and continue the test.
● If the room temperature exceeds the normal working temperature range of the instrument, analysis results
will not be reliable.
7.6.2 View diagram
The graphs of the test results can be viewed by clicking the DIFF scattergram on the BF-6960CRP sample analysis
or graphic review interface, as shown in the figure below:

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Fig. 7-6-3
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The histograms of red blood cell and platelet, and scattergram information of five classifications of WBC.
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In BF-6900CRP, the DIFF scattergram cannot be clicked and there is no information about the three graphs
at the left side.
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7.6.3 View of research parameters

In Fig. 7-6-3, click [Study parm.], and then research parameters of 10 items can be viewed as shown in the figure
below:

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Fig. 7-6-4
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Including BLAST#(blast number), BLAST%(blast percentage), IMM#(immature cells number), IMM%(immature
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cells percentage), LEFT#(left shift cells number), LEFT%(left shift cells percentage), ABNLYM#(abnormal
lymphocytes number), ABNLYM%(abnormal lymphocytes percentage), NRBC#(neucleated red blood cells
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number), and NRBC%(neucleated red blood cells percentage).

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7.7 Analysis of pre-dilution samples

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Confirm if the work mode of the sample is "Pre-dilute", if not, switch the current mode to "Pre-dilute" mode.
(1)Click [Mode] on the sample analysis interface, and the interface will pop up as shown below:
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Fig. 7-7-1
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If no barcode reader is connected, the “Two-way LIS” option will not be displayed on the interface.
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(2)Switch the analysis mode to pre-dilution.

(3)Refer to 7.6.1 for other operations.
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7.8 Sample analysis under automatic whole-blood mode

7.8.1 Bar code and pasting requirements
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(1)Bar code type: Code39, code93, code128, codebar, and interleaved 2 of 5.

(2)Size of bar code label:
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Code39 supports 4-12 digits.

code93, code128, and codebar support 4-20 digits.
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interleaved 2 of 5 supports 4-20 digits.

(3)During the cutting, the start blank and end blank of the barcode shall be≥3mm, barcode width＞10mm, and
barcode total length (blank+effective length of barcode≤45mm, as shown in the figure.

Bar code width

Start blank Effective length of End blank

bar code
Fig. 7-8-1

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(4)Requirements for pasting bar code labels:

a)Before pasting a barcode, tear off the label attached to the test tube.
b)Bar code pasting shall be neat without puckering.
c)The bar code shall be pasted in the correct position, as the figure shown below, without tilting and puckering.

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Fig. 7-8-1(a)

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7.8.2 Change of mode

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Confirm the analysis mode is automatic whole-blood mode, or set the current mode as “Auto-WB” according to the
following operation. CO
(1)Click [Mode] on the sample analysis interface, and the interface will pop up as shown below:
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Fig. 7-8-2
Select the mode as “Auto-WB” mode.
(2)After the setting, click [Save] to make the operation mode automatically switch to the “Auto-WB” mode.

● If no barcode reader is connected, the “Two-way LIS” option will not be displayed on the interface.

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● The upper limit of the input sample number is 12 bits, and "—" is valid, but "." is invalid.
7.8.3 Sample analysis steps

● Set the reference value range of the parameters on [Setting] interface before the test, or there may be an
alarm prompt of incorrect result after the test.
● Conduct the sample analysis directly after selecting work mode, and the defaulted reference range of the
instrument is "Normal". After the analysis, the alarm of the instrument is given in accordance with the
reference value range of "Normal" setting.
● Disposable vacuum blood collecting tube can be used five times at most, since the fragments produced by
repeated puncturing may lead to inaccurate test results.
(1)Click [Start] on the sample analysis interface, and the interface will pop up as shown below:

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Fig. 7-8-3
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When the instrument is under standby status, put the prepared sample tubes on test tube rack in sequence and put the
test tube rack at the right side of sample feeder (with the side with groove at bottom facing left). Click the [Start] in
Fig. 6-6-1 and the instrument will execute sample analysis in a sequence of the sample position. In the test process,
the operation status at the bottom of the software interface will display as "Under test".
(2)Test result of each sample after the test shall be saved on history query interface. After all the tests are completed,
the test tube rack will automatically move to the left side of the sample feeder, and the operator can remove it.

Click "Start" and "Stop" is displayed on the button.

(3)In the test process, [Stop] can be clicked to supplement reagent.

7.9 Analysis of emergency samples

(1)In the analysis process of automatic feeding (batches), if the emergency samples need to be analyzed with
priority, click "STAT" on the sample analysis interface, and the instrument will test the punctured samples, then
stop automatic feeding, and the operation mode will switch to the "Closed" mode, and the interface shown in figure
below will pop up:

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Fig. 7-9-1
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a)The defaulted emergency sample ID starts from 0-1.
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b)Analysis mode: whole blood or micro-whole blood or pre-dilution.

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c)Test mode: CBC or CBC+DIFF or CBC+DIFF+CRP or CRP or CBC+CRP.

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(2)If it is a vacuum blood collecting tube, select [WB] under analysis mode; if it is a micro-blood test tube, select
[Micro-WB] under analysis mode; if it is pre-dilution sample, select [Pre-dilute] under analysis mode. After a
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correct selection, click "OK" and the STAT chamber will automatically move to the test position as shown in the
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figure below:
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Fig. 7-9-2

● When the analysis mode is “Micro-WB”, a tube adapter is required for count.
● Emergency samples can only be tested in the analysis mode of "WB" or "Micro-WB" or "Pre-dilute".
Click "STAT" and "Stop STAT" is displayed on the button.
(3)Put the prepared emergency samples at STAT position and press "Count" to start the test. In the test process, the
operation status at the bottom of counting interface displays "In testing" and the sample test results will be saved in

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history for query.

(4)After the test, the STAT chamber will automatically recover to the initial position and prepare for testing the next
sample. To continue the test, click "Stop STAT". As shown in figure below:

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Fig. 7-9-3
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If the room temperature exceeds the normal working temperature range of the instrument, the analysis
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results will not be reliable.

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7.10 Parameter alarm

7.10.1 Parameter alarm type
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Parameter alarm comprises of the following three types:

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(1)When there are prompts of "↑, ↓" or "H", "L" in the counting results, it indicates that the counting results exceed
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the pre-set reference value range.

(2)When the counting results display as "*.**", it indicates that the test results are invalid or exceed the display
range.
(3)When the counting results include hole blockage, "?" will be displayed behind the hole blockage results. ”
7.10.2 Abnormal alarm for classification or morphology
The instrument can give abnormal or suspicious alarms for WBC, RBC/HGB and PLT according to scattergrams
and histograms, and the prompt information is as shown in the table below:
Table 7-10-1
(1) Abnormal alarm information for WBC

Information Meaning Judgment standard

Abnormal scattergram of white
Abnormal scattergram of white blood cells Abnormal channel scattergram of DIFF
blood cells?
Leukocytosis High count of white blood cells WBC>18.0*10^9/L

Hypoleucocytosis Low count of white blood cells WBC<2.5*10^9/L

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Information Meaning Judgment standard

Increase of neutrophils High count of neutrophils NEUT#>11.0*10^9/L

Neutropenia Low count of neutrophils NEUT#<1.0*10^9/L

Increase of lymphocytes High count of lymphocytes LYM#>4.0*10^9/L

Lymphopenia Low count of lymphocytes LYM#<0.8*10^9/L

Increase of monocytes High count of monocytes MON#>1.0*10^9/L

Increase of eosinophils High count of eosinophils EOS#>0.7*10^9/L

Increase of basophils High count of basophils BAS#>0.2*10^9/L

(2)Suspicious alarm information of WBC

Information Meaning Judgment standard
A quantity of scatter points exist in the
Left shift of nucleus? There could be a left shift
nucleus left shift area in the scattergram
Proportion of immature cells is bigger than
Immature cells? There could be immature cells

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the set reference value

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Heterotypic/abnormal There could be heterotypic or atypical Heterotypic or atypical lymphocytes are
lymphocytes lymphocytes bigger than the set reference value
There is red blood There could be incomplete hemolysis of

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Dense scatter points in the area between
cells/platelets RBC or immature stage of red blood cells
lymph and shadow cells
agglutination or platelets agglutination

(3)Abnormal alarm information of RBC/HGB

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Information Meaning Judgment standard

Abnormal distribution of red Abnormal distribution of red blood cells in
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Abnormal histogram of red blood cells

blood cells the histogram
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Uneven sizes of red blood cells Uneven sizes of red blood cells RDW-SD>65 or RDW-CV>20
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Small cellular red blood cells Small MCV MCV<70fL

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Large cellular red blood cells Large MCV MCV>110fL

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Increase of red blood cells Increase of red blood cells RBC>6.5*1012/L

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Anemia Anemia HGB<100g/L

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Hypochromia Hypochromia MCHC<290g/L

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Two or more wave crests in the

Bimodality Bimodal distribution of red blood cells
histogram of red blood cells
Abnormal distribution of ghost cells in
Chyle Chylemia
basophil scattergram

(4)Suspicious alarm information of RBC/HGB

Information Meaning Judgment standard
Suspicious of red blood cells There could be inaccurate red blood cells or Analyze and compare the results of
or hemoglobin? hemoglobin hemoglobin and red blood cells
Abnormal There could be abnormal hemoglobin or Calculate and compare the special
hemoglobin/interference? interference analysis parameters

(5)Abnormal alarm information of PLT

Information Meaning Judgment standard
Increase of platelets Increase of platelets PLT>600*109/L
Thrombocytopenia Thrombocytopenia PLT<60*109/L
Abnormal distribution of Abnormal distribution of platelets in the Abnormal histogram of platelets

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Information Meaning Judgment standard

platelets histogram

(6)Suspicious alarm information of PLT

Information Meaning Judgment standard
Calculate and compare the special
Platelets agglutination? There could be platelets agglutination
analysis parameters

7.11 Sleep
When the stop time of the instrument meets the automatic sleep time set by the software, it enters hibernation and
displays the instrument sleep status in the status bar. After the instrument enters hibernation, the screen will sleep at
the same time. Click anywhere on the screen to wake up the screen. If you want to continue the instrument operation,
press the counter key and the system will continue to operate after it wakes up.

7.12 Rinsing and unblocking

The instrument will rinse the components where sample flows through automatically in each counting period to
ensure no samples left in the liquid path, and the rinsing parts are as follows:

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(1)Internal and external sides of the aspiration probe.

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(2)Count cell.

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(3)Flow count chamber.
When instrument gives prompt "blocking", execute unblocking operation on [Maint.]→ [Service] → [Maintenance]
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interface (equal to executing operation of "Cauterize" and "Back washing" functions).

7.13 Turn-off
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In order to ensure stability of instrument and accuracy of analysis results, after a continual working of 24
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hours, operator shall execute shutdown operation according to the following steps.
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Click [Menu] - [Shutdown] to pop up the prompt box as shown below:

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Fig. 7-13-1
(1)If the instrument has a sample feeder, place the probe detergent prepared at the STAT position and click Count to
execute the instrument turn-off process.
(2)If the instrument does not have a sample feeder, place the probe detergent prepared below the sampling probe and
click Count to execute the instrument turn-off process.

Fig. 7-13-2

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In the shutdown process, execute the soaking and rinsing of pipeline and count cell. After the two actions are
executed, prompt box shown below will pop up:

Fig. 7-13-3
At this time, the operator can turn off the instrument and set the power switch of the host to “O” to shut down the
instrument.
After shutdown, empty and properly deal with the waste liquid in the waste liquid tank.

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Chapter 8 History query

8.1 Overview
The instrument will automatically save the analysis results in the database after executing sample analyzing each
time. The instrument can store up to 200000 (BF-6900CRP)/ 500000 (BF-6960CRP) sample analysis results. The
administrator can query all the sample results stored in the database. If sample storage capacity is larger than the
maximum, previous sample results will be overlaid automatically by the software.
Select [History] on the main interface and the interface is shown below:

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Fig. 8-1-1
The results in the sample database are displayed in the form of list by the testing order.
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If the current screen does not fully display, press at the bottom of the screen to
turn the page.
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8.2 Selection of record

Click [Selection] in Fig. 8-1-1 to look up the sample results in the known position of the sample database:

Fig. 8-2-1
Enter the selection range and click [OK]. The result of entering the sample number is displayed on the current screen

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and is selected.

The input sample position shall be within the scope of the sample database, otherwise a warning "the input
beyond the maximal scope" will prompt.
To cancel the selected sample, click [Unselect] in Fig. 8-1-1, then all selected samples will be unselected and the
sample number at the current position will become 0 in the status bar.

8.3 Query
The user can query data in the sample database by selecting different conditions. Click [Query] in the bottom menu
bar in Fig. 8-1-1, and the interface as shown below will pop up:

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Fig. 8-3-1
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Query conditions: sample ID, analysis mode, test mode, name, case number, department, cost type, test date,
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unaudited, unprinted, and not communicated. Query can be made by one of these conditions, or by different
combinations. Moreover, query can be operated by selecting "not checked today" or "not printed today".

8.4 Audit and cancel audit

Users can select the sample in the result query. In Fig. 8-1-1, click [Audit] or [Cancel audit] to change the result
status.

8.5 LIS transmission

The operator can manually transmit the selected result to the LIS system.

8.6 Delete
In Fig. 8-1-1, select the record to be deleted, and click [Delete] in the interface, as shown in the figure below:

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Fig. 8-6-1
Click [OK] to delete the selected record.

8.7 Image review

Users can check single record in the graphic form, select a sample in Fig. 8-1-1 and then click [Image review] on the
interface, as shown below:

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Fig. 8-7-1
The arrangement of sample database and total number of samples are displayed in the status bar in the form of
"position/total number".
On this interface, users can review and edit information and results and perform histogram adjustment.
8.7.1 Edit information
Click [Edit info] in Fig. 8-7-1, as shown in the figure below:

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Fig. 8-7-2
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Edit the sample information in the corresponding text box and then click [Save] to finish editing. The sample
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number, analysis mode, and test time are not editable.

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8.7.2 Edit results

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Click [Edit result] in Fig. 8-7-1:

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Fig. 8-7-3
After directly modifying the result value of the corresponding parameter, click [Save] and return to the interface

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shown in Fig. 8-7-1.

After modification of the results, the sample records are shown in italics in the graph review and sample
analysis interfaces.
8.7.3 Histogram adjustment
In Fig. 8-7-1, click [Histogram] to enter into the histogram adjustment window, as shown in the figure below:

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Fig. 8-7-4
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(1)There are histograms of RBC and PLT on the right side of histogram adjustment window; and every parameter
value is displayed on the left side as well. The RBC and PLT histograms have two vertical lines on both left and
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right. The vertical line is the classification line, and the two vertical line intervals are the value areas. On the left side
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of the histogram it shows the names of all the vertical lines displayed in the radio format. Select the name of the
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vertical line to be modified. Click and , and adjust the position of the selected vertical line.
The left parameter value will change with the adjustment line. For example, when adjusting the left classification
line of the RBC histogram, both the RBC parameter value and the RBC related parameter value change.
(2)Click [Save] after adjustment to save the results.
(3)Cancel: Return to the sample analysis interface.

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Chapter 9 System maintenance

9.1 Overview
To guarantee the effective operation and lengthen the service life of the instrument, users shall have routine
maintenance for the instrument according to requirements. Although the instrument will automatically give prompt
to remind users to execute corresponding maintenance after testing a certain amount of samples or continuously
operating for a certain time, and the software system is provided with a special service menu which will show the
measures of routine maintenance or in case of failure, users shall make appropriate maintenance and servicing plan
as per specific laboratory conditions, such as the daily sample volume, operating environment and operating time of
the instrument, to reduce factors that affect analysis accuracy and to guarantee the normal operation of instrument
system.

● Don't spill reagent, sample or waste liquid on the mechanical or electrical parts of the instrument in case of
any damages.
● During operation, operators shall take preventive measures like wearing protective gloves and working
clothes, or they may be infected after touching the polluted area or solution. Please wash with water and take

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disinfection measures if touching any polluted liquid.

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● During rinsing and maintenance, please check whether parts containing liquid lose efficiency as they may

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cause hazards.
● The instrument is installed with a laser. Operator shall check the warning labels during maintenance and
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servicing process, but not stare forward the light beam directly or through the optical instrument. Please
wear protective glasses when looking straight at laser source.
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● Improper maintenance may cause instrument damage. Operators shall maintain the instrument according
to the user manual.
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● If the instrument is installed with accessories which are not provided or recommended by the
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manufacturer or the instrument is used otherwise specified by the manufacturer, the relating protection may
be weakened.
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● During maintenance process, please check whether there are hazards caused by inefficiency of hoses or
parts filled with solution.
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● For the problems without solutions in the User Manual, please contact the after-sales service department
of the manufacturer to obtain suggestions from professional personnel.
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9.2 Maintenance guide

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9.2.1 Regular maintenance

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To maintain the best working state of instruments, scheduled maintenance is necessary, and it is respectively
described as below:
(1)Daily maintenance:
Carry out AC before blood sample analysis every day according to "Chapter 5 Quality control".
If the instrument is not shut down for 24 hours, execute "Rinse tubing" once every day: click
[Menu]→[Maint.]→[Service]→[Rinse] and [Tubing] to execute the operation.
If the instrument is not shut down for 24 hours, execute [Rinse WBC cell], [Rinse RBC cell], [Rinse sheath flow
cell], [Rinse CRP1 cell] and [Rinse CRP2 cell] once a day: click [Menu]→[Maint.]→[Service]→[Rinse] to execute
the operation of each cell.
(2)Weekly maintenance:
If the instrument is turned on or off normally every day, execute "Soak" (WBC cell, RBC cell, sheath flow cell,
CRP1 cell, CRP2 cell) once a week (execute through selecting [Menu]→[Maint.]→[Service]→[Maintenance]).
(3)Monthly maintenance:
If the instrument is shut down or opened normally, execute [Rinse sample-aspirating probe] every month (execute
through selecting [Menu]→[Maint.]→[Service]→[Rinse]).

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9.2.2 Timely maintenance

Users can set automatic rinsing interval in "Setting" (setting range: 10-200 times), and the instrument will
automatically execute rinsing after reaching the set test number.
If sheath flow cell is polluted, execute [Maint.]- [Service] - [Rinse] - [Sheath flow cell] to execute the rinsing
operation.
When instrument is left unused for over 2 weeks, replace reagent with distilled water, and click
[Menu]→[Maint.]→[Service]→[Maintenance] - [Package rinsing], then interrupt distilled water supply, and
execute [Package draining], after finishing the two operation above, place the instrument at a clean and dry position.
When instrument gives prompt "blocking", press [Menu]→[Maint.]→[Service]→[Maintenance] - [Unblock] to
execute unblocking operation or execute [Cauterize] and [Back washing].
When instrument is left unused for a long time, after startup, select [Menu]→[Maint.]→[Service]→[Filling]
successively and execute the operation of [BF-5D diluent], [BF-FDOⅠ lyse], [BF-FBH lyse], [BF-FDT I lyse], and
[BF-CRP lyse].
When the instrument works under a normal working environment and state, the analysis result is reliable.
If other failure prompt is given, please refer to troubleshooting table.

9.3 Maintenance

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9.3.1 Basic status
Click [Menu] - [Maint.] - [Basic status], as shown in the figure below:

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Fig. 9-3-1
The followings are the description about the basic state in the figure above:
(1)Temperature: display the ambient temperature, pre-heating cell temperature, CRP refrigeration temperature,
CRP reaction cell temperature, colorimetric ware temperature and the normal range of each temperature.
(2)Pressure: display the positive pressure, negative pressure, the pressure of sheath flow cell and normal pressure
range.
(3)Voltage: display the voltage value in small holes of red blood cell and the normal voltage range.
(4)Current: display the laser current and normal current range.

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9.3.2 System version

Select [Menu]-[Maint.]-[SY Ver.] to view the version information of each circuit board. The interface is as shown in
the figure below:

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Fig. 9-3-2
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Version number in the figure is for reference only, the version number of software will change with the
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upgrading of the program.

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9.3.3 Service
The software provides many maintenance functions to guarantee the accurate and effective operation.
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9.3.3.1 Replace/ fill

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Conduct background test after replacing diluent and lyse, and execute sample test when background test result is
within the normal range. Click [Menu] - [Maint.] - [Services] and select the [Replace]/[Fill] tab.
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(1)When it is necessary to replace some reagent, proceed as follows:

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Fig. 9-3-3
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a)Replacement of BF-5D diluent
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If the BF-5D diluent tubing contains bubbles or the BF-5D diluent is polluted or used up and the entire tank of
BF-5D diluent needs to be replaced, click [BF-5D diluent] and it will prompt "Replacing BF-5D diluent...". If the
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progress bar disappears, it means the replacement is completed.

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b)If any lyse should be replaced, the steps are the same with the replacement of BF-5D diluent.
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(2)If to fill the single reagent, follow the steps of Fig. 9-3-4 as detailed below:
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Fig. 9-3-4

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a)Filling of BF-5D diluent

When BF-5D diluent needs to be filled after emptying, click [BF-5D diluent] and it will prompt “Filling BF-5D
diluent”. Wait until the progress bar prompts completion.
b)If any lyse should be filled, the steps are the same with the filling of BF-5D diluent.

When software gives prompt of no BF-FDO I, the instrument will automatically fill BF-FDO I lyse after
corresponding failure information in "Fault information area" is eliminated.
9.3.3.2 Rinse
Click [Menu] - [Maint.] - [Service] and select the [Rinse] tab, as shown in the figure below:

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Fig. 9-3-5
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(1)If WBC, HGB or WBC classification related parameters are found abnormal in background test, execute "Rinse
WBC cell" operation. Click [WBC cell] and it will prompt "Rinse WBC cell". The rinsing is finished when the
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progress bar comes to an end.

(2)When abnormal parameter value of background test relevant to RBC and PLT is founded, execute "Rinse RBC
cell" operation. Click [RBC cell] and it will prompt "Rinse RBC cell". The rinsing is finished when the progress bar
comes to an end.
(3)To avoid the interference of count result by the pollution of sampling parts, rinse the sampling probe and swab
after every month of instrument operation. Click "Sampling probe" to execute the "Rinse sampling probe" operation
and it will prompt "Rinsing sampling probe". The rinsing is finished when the progress bar comes to an end.
The swab rinsing steps are same with that for sampling probe.
(4)When abnormally expanded cell population appears in scattergram, and the value of parameter background test
relevant to WBC is high, there may be air bubbles in flow cell. Execute the "Rinse sheath flow cell" operation, click
[Sheath flow cell] and it will prompt "Rinse sheath flow cell". The rinsing is finished when the progress bar comes
to an end.
(5)If CRP parameters are found abnormal in test, execute "Rinse CRP1 cell" or "Rinse CRP2 cell" operation, click
"CRP1 cell" and it will prompt "Rinse CRP1 cell". The rinsing is finished when the progress bar comes to an end.
The CRP2 cell rinsing steps are same with that for CRP1 cell.
(6)If the instrument is not shut down for over 24 hours and "Rinse tubing" is required to be conducted every day,

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execute "Rinse tubing" at this moment.

Click [Tubing] and it will prompt "Rinse tubing". The rinsing is finished when the progress bar comes to an end.
9.3.3.3 Maintenance
Click [Menu] - [Maint.] - [Service] - [Maintenance], as shown in the figure below:

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Fig. 9-3-6
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(1)Drainage
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During the maintenance of pipeline system of the instrument, execute drainage before maintenance to prevent the
spill of liquid, the followings are the specification, taking draining waste liquid disk as example:
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a)Draining waste liquid bottle can drain the liquid in waste liquid bottle and tubing. Click [Waste bottle] and it
will prompt "Drain waste liquid bottle". The draining is finished when the progress bar comes to an end.
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The operation to drain "WBC cell", "RBC cell", "CRP1 cell" and "CRP2 cell" is the same as above.
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b)If the instrument will not be used for 3 days- 2 weeks, the tubing should be drained. Click [Tubing] and it will
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prompt "Drain tubing" query information, as shown in figure below.

Fig. 9-3-7
Click [OK] and a prompt box shown below will pop up:

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Fig. 9-3-8
After removing the reagent, click [OK] and it will prompt "Drain tubing". The draining is finished when the
progress bar comes to an end. After the drainage of liquid in tubing, place the instrument in a clean and dry place.
c)If the instrument will not be used for over 2 weeks, replace the reagent with distilled water and execute
"Package rinsing" operation. Click [Package rinsing] and it will prompt "Package rinsing". The package rinsing
of tubing is finished when the progress bar comes to an end.
Then, cut off distilled water and execute package draining. The operation steps are the same with steps for
draining tubing. Then, the tubing draining operation is finished. After finishing the two operations above, place
the instrument at a clean position.

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(2)Aperture

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As sundries will be attached in aperture after long time of using, unblock, cauterize and back wash the aperture to

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clear the attached sundries.
a)Click [Cauterize] to cauterize the two ends of the aperture with high voltage DC, and meanwhile, pop up the
progress bar "Cauterize". CO
Clear sundries blocked in aperture to prevent and eliminate RBC blocking failure.
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b)Click [Back washing] to flush the aperture, and meanwhile, pop up the progress bar "Back washing".
Assistance in cauterization can prevent and eliminate RBC hole blockage.
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c)Click [Unblocking], a progress bar "Unblocking" pops up, then the instrument will execute cauterization and
back washing. The progress bar ends and the task is complete.
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(3)Soak
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To guarantee the accuracy of the testing result of the instrument, soak WBC cell, RBC cell and sampling probe with
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probe detergent under the following situation:

a)The instrument is blocked;
b)The instrument shows abnormal classification.
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(1)Soak RBC cell:

Soak and rinse RBC cell every other week, and the operation steps are as below:
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Click [RBC cell] and a dialog box as shown below will pop up:

Fig. 9-3-9
If the instrument has a sample feeder, place the probe detergent at the STAT position and click Count, and the
interface below will appear:

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Fig. 9-3-10
After soaking, a dialog as below pops up:

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Fig. 9-3-11

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Click [Next] to start rinsing RBC cell. When the progress bar comes to an end, it shows the end of the process.

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Fig. 9-3-12
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It the instrument does not have a sample feeder, the prompt box below will pop up.
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Fig. 9-3-13
Put the probe detergent below the sampling probe according to prompt and the steps are same with that with a
sample feeder.
(2)Soak WBC cell:
Soak WBC cell every two weeks, and the operation steps are same with the soaking of RBC cell.
(3)Soak sample aspirating probe:
Soak rinsing sample-aspirating probe every month, and the operation steps are as below:
Click [Maintenance] - [Sampling probe] to pop up the prompt box as shown below:

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Fig. 9-3-14
Place the Probe cleanser at the STAT position and click Count, and the interface below will appear:

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Fig. 9-3-15

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The soaking is finished when the progress bar comes to an end.
9.3.4 HGB verification
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Click [Menu] - [Maint.] - [HGB verification], as shown in the figure below:
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Fig. 9-3-16
Click [Verification] in the figure, and HGB verification value will be displayed in the box following "Verification".
9.3.5 Mechanical detection
9.3.5.1 Whole machine
Click [Menu] - [Maint.] - [Mechanical inspection], as shown in the figure below:

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Fig. 9-3-17
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(1)Motor:
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When some part of the instrument breaks down, the failure can be judged by motor detection. This program sets the
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following motors: lifting motor, rotary motor and rinsing motor. Click [Detection] after the corresponding motor
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and the test result will be displayed on the screen ("Success" or "Failure").
(2)Valve:
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If the instrument works abnormally due to valve failure, valve detection can serve as an important method to
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eliminate liquid path failure.

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Valve status after the test is completed: Yellow indicates successful detection and red indicates failed detection.
The operation process is as follows:
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Click the corresponding number of the valve (numbers in Fig. 9-3-17 refer to the valves), and the instrument will
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automatically detect the valve. Click the valve number and the sound of opening/closing the valve can be heard,
which suggests that the valve is in a normal state.
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Click [Detection] after automatic detection, and the instrument will automatically detect the valves in order.
Meanwhile, the valve opening and closing sounds should be able to hear.
(3)Pump:
Click "Positive pressure" or "Negative pressure" to check whether the pump is under normal status.
After detection, click [Sample analysis] at the upper part of the screen to exit mechanical detection interface and
return to main interface.

● Valve detection and positive/negative pressure pump detection cannot be executed at the same time.
● After exiting from the “Mech. test” interface, the Analyzer automatically performs the whole machine
resetting.
9.3.5.2 Sample feeder
Click [Menu] - [Maint.] - [Mech.test] and select the [Sample feeder] tab, as shown in the figure below:

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Fig. 9-3-18
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When some part of moving parts of the sampler breaks down, the failure can be judged by motor detection. The
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program of motor detection includes: loading motor, rack-conveying motor, emergency feeder motor, unloading
motor, shaking & lifting motor, pinch motor, bar code scanning motor click [Detection] on the back of
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corresponding motor, and the test result will be displayed on the screen ("Succeeded" or "Failed").
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The interface will not display the tab if no sample feeder is set.
If no barcode reader is equipped, the interface is as shown below:
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Fig. 9-3-18(a)
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9.3.5.3 CRP
Click [Menu] - [Maint.] - [Mech. test] and select the [CRP] tab, as shown in the figure below:
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Fig. 9-3-19
The detection method is same with that of whole machine.

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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.
9.3.6 Instrument registration
Click [Menu]-[Maint.]-[Instrument reg.], and the interface is as shown below:

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Fig. 9-3-20
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Enter the instrument registration code or click Import (import the registration code in the USB flash drive), enter the
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registration code and click Register. Registration success is prompted and the registration is completed.
9.3.7 Data backup
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Click [Menu] - [Maint.] - [Data backup], as shown in the figure below:

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Fig. 9-3-21
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After inserting the U disk in the USB interface behind the instrument, click [Backup] on the interface to export the
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data to the U disk for saving.

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If the user needs to restore the exported data, click [Recover] on the interface to export the data in the U disk into the
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instrument.
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Data should be backed up regularly to prevent data loss when hardware or software fails.
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9.3.8 Counter
Click [Menu] - [Maint.] - [Counter], as shown in the figure below:
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Fig. 9-3-22
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(1)The sampling syringe, rinsing syringe and sheath syringe operation times, as well as the operating time of the
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positive pressure pump and negative pressure pump (in unit of s) and probe puncturing times can be viewed.
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(2)Users can view the operating times of the CRP syringe and the operating time of CRP negative pressure pump (in
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unit of s).

9.4 Replacement of vulnerable parts

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9.4.1 Replacement of sampling probe

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During the instrument testing, the probe tip will get worn by the puncturing movement to some degree, so that it is
recommended to replace the sampling probe when the sampling tests are up to 30,000 times as per the methods
below:
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(1)First unscrew the two screws 1 & 2 of the sampling probe and draw out the sampling probe upward vertically as
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shown in the figure below:

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Swab

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Fig. 9-4-1

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Screw off the connectors on the upper part of the sampling probe to replace with a new sampling probe as shown in

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the following figure:

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Fig. 9-4-2
Insert the new sampling probe vertically into the swab (as shown in Fig. 9-4-2) and fix the screws 1 & 2 (as shown
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in Fig. 9-4-1).

9.5 Maintenance of the instrument before stopping using

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Take the following measures to maintain the Analyzer before maintenance or treatment:
(1)Remove reagent bottles and waste liquid tanks at the back of the Analyzer before handling.
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(2)Carry only after confirming finishing "pipeline draining and packing".

(3)Use transport machine such as utility trolley for the stable transportation of short distance.
(4)Prevent the aspiration probe from other objects and being damaged during handling and transportation processes.
(5)Keep the instrument vertical, not tilting or side laying when moving and carrying.
(6)Avoid vibration during carrying, and check and adjust the Analyzer after carrying to make sure it is normal
before using.

9.6 Rinsing and maintenance of the instrument

Clean the surface of the instrument regularly to keep it tidy. Wipe the surface with a wet and soft cloth or gauze,
dipped with a small amount of 75% ethanol if necessary. However, please do not wipe the surface of the Analyzer
with any organic solvent to prevent damaging the shell.
In rinsing, the operator shall pay attention to the following matters:
(1)Take proper disinfection measures in case of hazardous substance leaked on the surface or inside the equipment.
(2)Don't use the detergent or sanitizer with possibility of danger due to chemical reaction with parts or materials in
equipment. (Soft cloth dipped with a small amount of 75% ethanol can be used for disinfection)

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(3)In case of doubts about the compatibility between sanitizer or detergent and parts or materials in equipment,
please consult the manufacturer or its agencies.

9.7 Disposal of waste liquid

The Analyzer will produce waste liquid containing clinic whole-blood and reagent for analysis of blood cells during
normal operation period, and according to the national laws and regulations, the waste liquids shall be discharged
only after disinfection. The waste liquid produced by the Analyzer shall be disposed in accordance with the
following requirements before discharging:
The "84 disinfectant" and waste fluid can be mixed up at scale of 1:50 for disinfection before discharging.

Please handle the waste fluid of the Analyzer to prevent potential biological and chemical pollution.

9.8 Disposal of discarded instrument

Do not abandon the Analyzer randomly after its service life expires but inform of the manufacturer for recycle.

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Chapter 10 System log

10.1 System log

Click [Menu] - [Log] to display [All logs], as shown in the figure below:

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Fig. 10-1-1
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The operator can also select [Operation logs], [Fault logs], and [Other logs] in the interface tab to view.
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Chapter 11 Reagent management

11.1 Reagent registration

Click [Menu] - [Reagent], as shown in the figure below:

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Fig. 11-1-1
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The interface shows the reagent type, reagent volume, and expiration date. If the current reagent becomes invalid, it
will be marked with red in the validity information column.
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Click [Register], as shown in the figure below:

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Fig. 11-1-2
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(1)Input bar code information:
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If external barcode reader is not connected, input barcode information manually, and the operation is shown as
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below:
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Click the input box to correctly input the bar code information on the outer case of the reagent packing box (click
[Clear] to empty the error message and enter new message), and after input, the registration will be done
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automatically. After successful registration, registration information changes accordingly.

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(2)Scan and input barcode information:

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Connect the bar code reader correctly (the other end of the bar code reader data cable is connected to the instrument
"USB" port), make the "bar code number" input box in the input state, scan the bar code on the reagent bottle with
the bar code reader to make the bar code is automatically generated in the input box after the "bar code number".
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After the registration is successful, the registration info changes accordingly.

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(3)Relevant prompt in case of failed scanning:

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When "Registration fails and the format of the bar code number is wrong" is prompted, check the input bar code to
see if it contains special characters.
When "Registration fails and the parsing of the bar code number is wrong" is prompted, check whether the input bar
code is correct.
When "Registration fails and the bar code has been registered" is prompted, repeat registration after replacing the
reagent.
When "Registration fails and the reagent expires", replace the reagent and register it again.
If there are other prompts, contact the manufacturer or agent.
(4)After the reagent registration is successful, replace the corresponding reagent on the interface of [Menu] - [Maint.]
- [Service] - [Replace].

The instrument reagent bar code does not allow cumulative registration. Registering a new bar code will
remove the original reagent margin.

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11.2 Reagent setting

Select the corresponding reagent and click [Setting], as shown in the figure below:

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Fig. 11-2-1
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The life of reagent can be modified. After the modification, click [Save] to exit the setting interface and enter the
interface shown in Fig. 11-1-1.
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If the selected reagent residual is 0, the validity cannot be set, as shown in the figure below:
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Fig. 11-2-2

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Chapter 12 Alarm information and handling

This chapter introduces all possible faults of the instrument, the analyses of fault causes, as well as the relating
handling method.

Analyzing the sample in the event of a failure may result in incorrect analysis. If a fault alarm occurs during
sample analysis, be sure to perform sample analysis after troubleshooting.

12.1 Overview
When the instrument fails, an alarm message will be displayed in the fault information area. In the "Shortcut key
area", click [Fault information area], as shown in the figure below:

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Fig. 12-1-1
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The fault information is displayed in the order of occurrence of faults: the last fault message is displayed at the top.
After selecting the corresponding fault information, view the solution to the selected fault in the "Alarm help"
column.
Then, press [Clear alarm] to clear the fault information, as shown in the figure below: 0………………………….

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Fig. 12-1-2
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After clearing, click [Close] to close the dialog box. If the alarm is not cleared or a new alarm occurs during the
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process, refer to the "Alarm help" column.

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12.2 Alarm information and troubleshooting

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Alarm code Alarm level Alarm description Solutions

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Abnormal communication of CRP

01-201-02 Stop
testing unit board
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Abnormal communication of analog

01-201-03 Stop
signal collection board
Abnormal communication of sample
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01-201-05 Stop 1. Please execute the clear alarm operation.

feeder control board 2. Please contact after-sales personnel if it
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Main control board communication cannot return to normal or other failures

01-201-06 Stop occur.
abnormal
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Abnormal communication of CRP unit

01-201-07 Stop
collection board

01-201-08 Partial stop Abnormal HGB background voltage

01-201-10 Partial stop BF-5D Diluent use times empty

01-201-11 Partial stop BF-FDOI Lyse use times empty

1. Go to the reagent management interface,
01-201-12 Partial stop BF-FDTI Lyse use times empty and register the corresponding reagent.
2. Please contact after-sales personnel if it
01-201-13 Partial stop BF-FBH Lyse use times empty cannot return to normal or other failures
occur.
01-201-14 Partial stop BF-CRP Lyse use times empty

01-201-15 Partial stop CRP reagent use times empty

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Alarm code Alarm level Alarm description Solutions

02-101-01 Stop CRP syringe motor fault

02-101-02 Stop CRP syringe sensor fault

1. Please execute the clear alarm operation.
2. Please contact after-sales personnel if it
02-101-03 Stop CRP syringe motor fault
cannot return to normal or other failures
occur.
02-101-04 Stop Refrigeration chamber motor fault

Refrigeration chamber motor sensor

02-101-05 Stop
fault
1. Please change the corresponding reagent.
2. Please execute the clear alarm operation.
02-111-30 Partial stop CRP lyse is insufficient 3. Please contact after-sales personnel if it
cannot return to normal or other failures
occur.
1. CRP reagent chamber door, and make sure
the reagent chamber is in place.

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CRP reagent chamber door is not 2. Please execute the clear alarm operation.
02-111-31 Stop
closed 3. Please contact after-sales personnel if it

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cannot return to normal or other failures
occur.

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02-131-06 Stop SV21 fault

02-131-07 Stop SV22 fault

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02-131-08 Stop SV23 fault

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02-131-09 Stop SV24 fault

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02-131-10 Stop SV26 fault

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02-131-11 Stop SV27 fault

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Refrigeration chamber temperature

02-91-13 Caution
sensor fault
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Refrigeration chamber temperature is

02-91-14 Caution
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too low 1. Please execute the clear alarm operation.

Refrigeration chamber temperature is 2. Please contact after-sales personnel if it
02-91-15 Caution
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too high cannot return to normal or other failures

CRP reaction cell temperature sensor occur.
02-91-16 Partial stop
fault
CRP reaction cell temperature is too
02-91-17 Partial stop
low
CRP reaction cell temperature is too
02-91-18 Partial stop
high
Colorimetric ware temperature is too
02-91-19 Caution
low
Colorimetric ware temperature is too
02-91-20 Caution
high
Colorimetric ware temperature sensor
02-91-21 Caution
fault

02-94-51 Stop Channel 1 sampling timeout

Channel 1 C-reactive protein reagent

02-94-52 Stop
adding timeout

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Alarm code Alarm level Alarm description Solutions

02-94-53 Stop Channel 2 sampling timeout

Channel 2 C-reactive protein reagent

02-94-54 Stop
adding timeout

03-182-01 Stop FLASH chip operation failed

1. Please execute alarm clearing operation.

2. Execute the upgrade operation again. If the
03-182-02 Stop FLASH chip operation failed
upgrade failed, please contact after-sales
personnel.
1. Please execute alarm clearing operation.
2. Execute the upgrade operation again. If the
03-182-03 Stop FLASH chip operation failed
upgrade failed, please contact after-sales
personnel.

03-183-01 Stop FPGA program loading failed

03-183-02 Stop FPGA program loading failed 1. Please execute the clear alarm operation.

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2. Please contact after-sales personnel if it

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cannot return to normal or other failures
03-183-03 Stop FPGA program loading failed occur.

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03-201-22 Stop Failed to discharge WBC cell fluid

03-93-01 Partial stop Laser tube current over high

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normal range.
2. Please execute the clear alarm operation.
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3. Please contact after-sales personnel if it

03-93-02 Partial stop Laser tube current over low cannot return to normal or other failures
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occur.
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1. Execute unblocking and then execute clear

alarm.
03-94-01 Partial stop Abnormal hole voltage in RBC cell 2. Please contact after-sales personnel if it
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cannot return to normal or other failures

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occur.
1. Please check whether there is foreign
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matter on the surface of the loading area.

2. Please execute the clear alarm operation.
05-101-01 Stop Loading motor operation failure
3. Please contact after-sales personnel if it
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cannot return to normal or other failures

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occur.
1. Please check whether there is foreign
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matter on the surface of the conveying &

delivering area.
Conveying&delievering motor 2. Please try to replace the test tube rack.
05-101-02 Stop
operation failure 3. Please execute the clear alarm operation.
4. Please contact after-sales personnel if it
cannot return to normal or other failures
occur.
1. Please ensure the front cover of the
instrument is in the closed status.
Barcode scanning motor operation 2. Please execute the clear alarm operation.
05-101-03 Stop
failure 3. Please contact after-sales personnel if it
cannot return to normal or other failures
occur.
1. Please check whether there is foreign
matter on the surface of the reclaiming area.
2. Please execute the clear alarm operation.
05-101-04 Stop Unloading motor operation failure
3. Please contact after-sales personnel if it
cannot return to normal or other failures
occur.

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Alarm code Alarm level Alarm description Solutions

05-101-05 Stop Lifting motor operation failure

1. Please execute the clear alarm operation.
2. Please contact after-sales personnel if it
05-101-06 Stop Clamping motor operation failure
cannot return to normal or other failures
occur.
05-101-07 Stop Emergency motor resetting failure

1. Check whether there is foreign matter on

the lifting motor track.
2. Please execute the alarm clearing
05-101-08 Stop Emergency motor operation failure operation.
3. Please contact after-sales personnel if it
cannot return to normal or other failure
occurs.
1. Please execute the clear alarm operation.
2. Please contact after-sales personnel if it
05-101-09 Stop Shaking action execution failure
cannot return to normal or other failures
occur.
1. Please execute the clear alarm operation.

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2. Please contact after-sales personnel if it
05-101-10 Stop Clamping motor operation failure

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cannot return to normal or other failures
occur.

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1. Please check whether the test tube rack
was moved.
05-101-11 Stop
Test tube rack position error before
mixing
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3. Please contact after-sales personnel if it
cannot return to normal or other failures
occur.
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05-101-12 Stop Clamping motor abnormal closing 1. Please execute the clear alarm operation.
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2. Please contact after-sales personnel if it

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cannot return to normal or other failures

05-101-17 Stop Loading motor operation timeout occur.
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1. Check whether there is foreign matter on

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the surface of the conveying & delivering

area.
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05-101-18 Stop Feeding motor operation timeout 2. Please execute the clear alarm operation.
3. Please contact after-sales personnel if it
cannot return to normal or other failures
occur.
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Barcode scanning motor operation

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05-101-19 Stop
timeout
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05-101-20 Stop Unloading motor operation timeout

05-101-21 Stop Emergency motor operation timeout

1. Please execute the clear alarm operation.
2. Please contact after-sales personnel if it
05-101-22 Stop Lifting motor operation timeout
cannot return to normal or other failures
occur.
05-101-23 Stop Clamping motor operation timeout

05-111-01 Stop Tube judging sensor signal abnormal

05-111-02 Stop Rack conveying failure

1. Please ensure the front cover of the

instrument is in the closed status.
Barcode scanning mechanism operation 2. Please execute the clear alarm operation.
05-111-03 Stop
failure 3. Please contact after-sales personnel if it
cannot return to normal or other failures
occur.

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Rack withdrawing mechanism

05-111-04 Stop
operation failure

05-111-05 Stop Shaking mechanism operation failure

05-111-06 Stop Rack withdrawing failure

05-111-07 Stop Test tube rack returning failure

1. Please execute the clear alarm operation.
2. Please contact after-sales personnel if it
05-111-08 Stop Clamping motor operation failure
cannot return to normal or other failures
Emergency mechanism operation occur.
05-111-09 Stop
failure

05-151-01 Stop Loading mechanism operation failure

05-151-02 Stop Emergency chamber operation failure

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05-151-03 Stop Emergency chamber operation failure

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05-151-04 Stop Rack conveying failure

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1. Please check whether there is foreign
05-151-05 Stop Rack conveying failure matter on the surface of the conveying area.
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3. Please contact after-sales personnel if it
05-151-06 Stop Rack conveying failure cannot return to normal or other failures
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05-151-07 Stop Rack conveying failure
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1. Please execute the clear alarm operation.

2. Please contact after-sales personnel if it
05-201-01 Stop Test tube rack is removed
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cannot return to normal or other failures

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occur.
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1. Please remove the test tube racks from the

reclaiming area.
2. Please execute the clear alarm operation.
05-201-02 Stop Reclaiming area full
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3. Please contact after-sales personnel if it

cannot return to normal or other failures
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occur.
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1. Please place the test tube rack correctly in

the loading area.
2. Please execute the clear alarm operation.
05-201-03 Stop No rack in the loading area
3. Please contact after-sales personnel if it
cannot return to normal or other failures
occur.

1. Please check whether the bar code on the

test tube is pasted on the roller.
2. Please check whether the bar code on the
05-201-04 Partial stop Bar code scan failure test tube is pasted abnormally.
3. If you find abnormal bar code sticking or
bar code sticking on the roller, please take out
the test tube rack and clear the alarm.

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Alarm code Alarm level Alarm description Solutions

1. Please check whether there is any foreign

matter or test tube rack to block the
rack-feeding in-position optocoupler. If so,
05-201-05 Partial stop Loading area abnormal please remove the foreign matter or remove
the test tube rack.
2. Please perform the alarm clearing
operation
1. Please check whether there is any foreign
matter or test tube rack to block the
rack-conveying in-position optocoupler. If so,
05-201-06 Partial stop Unloading area abnormal remove the foreign matter or remove the test
tube rack.
2. Please perform the alarm clearing
operation.

06-101-01 Stop Probe lifting motor failure

06-101-02 Stop Probe lifting motor sensor failure

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06-101-03 Stop Probe lifting motor failure

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06-101-04 Stop Probe rotating motor failure

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06-101-07 Stop Sample-aspirating motor fault
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06-101-08 Stop Sample-aspirating motor sensor fault 1. Please execute the clear alarm operation.
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2. Please contact after-sales personnel if it

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cannot return to normal or other failures

06-101-09 Stop Sample-aspirating motor fault occur.
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06-101-10 Stop Rinsing motor fault

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06-101-11 Stop Rinsing motor sensor fault

06-101-12 Stop Rinsing motor fault

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06-101-13 Stop Sheath motor fault

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06-101-14 Stop Sheath motor sensor fault

06-101-15 Stop Sheath motor fault

06-111-01 Partial stop Insufficient BF-5D diluent

1. Please change the corresponding reagent.
06-111-02 Partial stop Insufficient BF-FDOⅠ lyse 2. Please execute the clear alarm operation.
3. Please contact after-sales personnel if it
06-111-03 Partial stop Insufficient BF-FBH lyse cannot return to normal or other failures
occur.
06-111-04 Partial stop Insufficient BF-FDTⅠ lyse

06-131-01 Stop SV1 valve fault

1. Please execute the clear alarm operation.
2. Please contact after-sales personnel if it
06-131-02 Stop SV2 valve fault
cannot return to normal or other failures
occur.
06-131-03 Stop SV3 valve fault

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Alarm code Alarm level Alarm description Solutions

06-131-04 Stop SV4 valve fault

06-131-05 Stop SV5 valve fault

06-131-07 Stop SV7 valve fault

06-131-08 Stop SV8 valve fault

06-131-09 Stop SV9 valve fault

06-131-10 Stop SV10 valve fault

06-131-11 Stop SV11 valve fault

06-131-12 Stop SV12 valve fault

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06-131-13 Stop SV13 valve fault

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06-131-14 Stop SV14 valve fault

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06-131-15 Stop SV15 valve fault
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06-131-16 Stop SV16 valve fault
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06-131-17 Stop SV17 valve fault

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06-131-18 Stop SV18 valve fault

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06-131-19 Stop SV19 valve fault

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06-131-20 Stop SV20 valve fault

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06-131-28 Stop SV28 valve fault

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06-131-29 Stop SV29 valve fault

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06-131-30 Stop SV30 valve fault

06-131-31 Stop SV31 valve fault

06-151-02 Caution Waste liquid tank full

06-181-01 Stop CRP sample adding failure

06-181-02 Stop CRP reagent adding failure

1. Please execute the alarm clearing

operation
06-181-03 Stop Failed to aspirate the CRP reagent 2. Please contact after-sales personnel if it
cannot return to normal or other failure
occurs
Pre-heating unit temperature sensor 1. Please execute the clear alarm operation.
06-91-01 Partial stop
failure 2. Please contact after-sales personnel if it
cannot return to normal or other failures
06-91-02 Partial stop Preheating unit temperature is too low occur.

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06-91-03 Partial stop Preheating unit temperature is too high

06-91-04 Caution Fault of ambient temperature sensor

06-91-05 Caution Too low ambient temperature

06-91-06 Caution The ambient temperature is too high

06-92-01 Stop Sheath flow pressure is too high

06-92-02 Stop Sheath flow pressure is too low

06-92-03 Stop Gas negative pressure is too high

06-92-04 Stop Gas negative pressure is too low

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06-92-05 Stop Gas positive pressure is too high

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06-92-06 Stop Gas positive pressure is too low

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1. Execute the soaking operation of the

07-51-1 Caution CRP channel 1 blank is abnormal

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execute the clear alarm operation.
3. Please contact after-sales personnel if it
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cannot return to normal or other failures
occur.
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1. Execute the soaking operation of the

corresponding CRP channel.
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2. Please execute the clear alarm operation.

07-51-2 Caution CRP channel 2 blank is abnormal
3. Please contact after-sales personnel if it
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cannot return to normal or other failures

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occur.
1. Replace with the correct CRP reagent.
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2. Please execute the clear alarm operation.

07-51-3 Partial stop CRP test data abnormal 3. Please contact after-sales personnel if it
cannot return to normal or other failures
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occur.
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1. Please execute the alarm clearing operation

2. Please contact after-sales personnel if it
07-51-4 Stop CRP check failed
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cannot return to normal or other failure

occurs

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Chapter 13 Transportation and storage

13.1 Transportation
The transport of Analyzer is specified in the contract, during which fierce collision and placing together with
corrosive materials shall be prevented.

13.2 Storage
The packed instrument shall be placed in a well-ventilated room with temperature at -40℃~55℃, relative humidity
not more than 93% and where no corrosive gas exists.

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Appendix A Letter of guarantee

Dear users,
Thanks for buying the Automatic Hematology Analyzer (model: BF-6900CRP/ BF-6960CRP). Our company will
offer the following services:
(1)Technical consultation at any time.
(2)One-year free repair since the date of purchase.
(3)Paid services in the following cases:
a)The product out of warranty.
b)Product damage due to an accident or improper use.
c)Product damage due to non-compliance with the manual or self-repair.
Due to the technical advancement, the company will provide the upgrading service for Automatic Hematology
Analyzer (model: BF-6900CRP/ BF-6960CRP).

Please contact us according to the following information for technical support:

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After-sales Service Unit: Dirui Industrial Co., Ltd.

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Address: 3333 Yiju Road, New & High Tech. Development Zone, Changchun Post Code: 130103

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International Customer Service Hotline: +86 400 808 7597
International Customer Service E-mail: service@dirui.com.cn
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Domestic Customer Service Hotline: 400 811 6695 400 811 6605
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Domestic Fax: 0431-85100405

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Domestic Customer Service E-mail: service.ch@dirui.com.cn

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Appendix B Network communication interface protocol V1.7

B.1 Network communication interface protocol V1.7
The protocol is applicable to information transmission between Automatic Hematology Analyzer (model:
BF-6900CRP/BF-6960CRP) and the upper computer (LIS). It is in compliance with HL7 standard, and the HL7
version is 2.3.1.
B.2 Definitions
Message header (MSH): the first portion of each message is used to define the purpose and usage of messages, and
each message consists of several sections. The first segment of a message is the message head segment which shows
the program name, message type and the only message ID number for sending and reception, and the composition of
the following segments is determined by the message type. For example, a sample message is transmitted by the
section format OBR, and a test result message is transmitted by several OBX sections.
Segment: a message section consists of several data fields and each segment is provided with a name to define its
contents and function. For example, MSH, PID, and PV1.
Data field: a message section consists of several data fields. The fields are separated by separators.
B.3 Grammatical format

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<SB>dddd <EB><CR>

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<SB>: message start character (1 byte). ASCII character <VT>, i.e. 0x0B.

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dddd: data (composed of different length of bytes). This is HL7 data contents of the block. The data can contain any
values of single byte greater than the hexadecimal value 0x1F and carriage return of ASCII code, <CR>.
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<EB>: message end character (1 byte). ASCII character <FS>, i.e. `0x1C.
<CR>: carriage return (1 byte). ASCII character <CR>, i.e. 0x0D.
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For example:
<SB>MSH|^~\&|BCC3900|X1706900BF0001|||20090419104618||ORU^R01|1|P|2.3.1|||||CHN|UTF-8
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<CR><EB><CR>
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Where:
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The five characters after MSH are separators among data fields, assemblies and sub-assemblies. Although those
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characters are any non-text characters, the characters in the table below are recommended in HL7 standard:
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Delimiter value
Data field separator |
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Component separator ^
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Sub-component separator &

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Repeating delimiter ~
Quoting character \

B.4 Message section of the protocol

(1)MSH-Message header
(2)PID- Patient information
(3)PV1-Case
(4)OBR-Testing report information
(5)OBX-Testing report detection information
(6)MSA- Response
(7)ORC- Application
A. Introduction to Communication Process
The host directly sends the test results (or quality control data information) to LIS/HIS, as shown in Figure B-1.
R01 event: The PC connected to the host actively sends the test results to LIS. Both test results and QC data
messages can be sent this way.

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Figure B-1 Schematic diagram of communication of test results and quality control data

Note:
The host needs the LIS end to reply with an ACK^R01 message. If it does not receive the ACK^R01
message, it is determined that the result has not been transmitted to the LIS end (refer to IV. Transmission
Example-9, Sample and QC Response).
B. Work order information query
The work order belongs to Order information. You can use related HL7 messages: ORM (General Order Message)
and ORR (General Order Response Message). The communication process is shown in Figure B-2.

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Figure B-2 Schematic diagram of communication of work order query
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Note:
The system that receives the test results and the system that feeds back the work order may be distributed
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on different servers, so these two functions need to be configured with their service providers’
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communication methods separately.

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C. Mainly used messages

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ORU^R01 message: mainly used for transmission of test results and quality control data.
ORU Observational Results (Unsolicited) Description
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MSH message header, required, including communication information such as message number, sending time,
message separator, and encoding method
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PID patient basic information, including patient name, gender, medical record number, etc.
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PV1 patient consultation information, including patient type, department, charge type, etc.
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OBR sample information, including sample number, inspector, inspection time, etc.
{OBX} Inspection data items, including inspection parameter results and inspection related data such as work
mode, etc.
Note: The message segment in { } can be repeated one or more times.
ACK^R01 message: acknowledge the received ORU^R01 message.
ACK Acknowledgment description
MSH message header
MSA message acknowledgement, describing whether the communication message was successfully received
ORM^O01 message: General Order message, basically Order-related actions use this message type, such as
creating a new order, canceling an order, etc. Here is the host requesting LIS / HIS to refill the order message.
ORM General Order Message description
MSH message header
General information of {ORC} Order, including the number information of the queried sample
Note: The message segment in { } can be repeated one or more times.

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ORR^O02 message: Confirmation of ORM^O01 message. Here, the complete information of order (that is, work
order) is returned.
ORR^O02 General Order Response Message description
MSH message header
MSA message acknowledgement
PID patient information
PV1 patient consultation information
OBR sample information
{OBX} Other sample information data items, including sample work modes, etc.
Note: The message segment in { } can be repeated one or more times.
B.5 HL7 attribute list
The message sections of the agreement are classified as required, optional and repeatable.
MSH – message header: this section is required, including the basic information of HL7 message like the value of
message separator, message type and encoding system, and it is the first section of each HL7 message.
Message example:

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MSH|^~\&|BF-6900|X1706900BF0001|||20090419104618||ORU^R01|1|P|2.3.1|||||CHN|UNICODE

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No. Field name Length Description Examples

.,
Contains the delimiter between the
segment ID and the first real field,
1# Field Separator 1 |
CO
defining the field delimiter (|) for the rest
of the message.
Component separator, repetition
AL

2# Encoding Characters 4 separator, escaping separator, and ^~\&

sub-component separator（^~\&）.
I

Sender application program. For example:

3 Sending Application 180 BF-6900
TR

BF-6900
Sender equipment. Instrument code is
4 Sending Facility 180 X1706900BF0001
S

instrument ID.
DU

Receiving
5 180 Application program of receiving end. LIS
Application
IN

Time of current message. To call the time

information of the system.
Send time message to create time (in the
Date/Time Of
7 26 form of 20090419104618
I

Message
YYYY[MM[DD[HH[MM[SS]]]]]), and
RU

take the system time value. For instance,

20110310144704
DI

Message type, like ORU^R01. The format

is “Message type^Event type^Message
9# Message Type 7 ORU^R01
structure name”.
Value: ORU^R01 (sample)
Message control ID, which uniquely
10# Message Control ID 20 identifies a message and increases from 1 1
as the number of messages increases.
Process ID and always take P (indicating
11# Processing ID 3 the query information of samples and P
work lists); Q (QC count results)
12# Version ID 60 Version ID, HL7 protocol version: 2.3.1. 2.3.1
13# Complete State 3 Send end flag Default is 0, and end is 1
18 Character Set 10 Character set, UTF-8. UTF-8

MSA definition list

MSA - message acknowledgment segment
The MSH segment of the interface includes the following domains:

B-3
 User Manual

No. Field name Length Description Examples

Acknowledgment Acknowledgement code, AA indicates acceptance; AE
1# 2 AA
Code indicates error; AR indicates rejection.
2# Message Control ID 20 Message control ID, same to sender’s MSH-10. 1
6 Error Condition 100 Error condition (status code).

The value of MSA-6 field is shown in the table below:

Status code (MSA-6) Status text (MSA-3) Description/Remark
Success AA
0 Message accepted Succeeded
Error status code AE
Sequence of middle message segment is incorrect
100 Segment sequence error
or necessary fields are missing.
101 Required field missing Required fields in a segment are missing.
Field data type error, like the figure is written in
102 Data type error
character.

D
103 Table value not found Tabular value not found, not used temporarily.

LT
Status code rejected AR

.,
200 Unsupported message type Message type not supported.
201 Unsupported event code COEvent code not supported.
202 Unsupported processing id Handling ID not supported.
AL

203 Unsupported version id Version ID not supported.

Unclear key identifier, like transmitting the
I

204 Unknown key identifier

information of a nonexistent patient.
TR

205 Duplicate key identifier Existing repeated key identifier.

S

Affair cannot be executed in application program

206 Application record locked
DU

storage level, like database being locked.

207 Application internal error Other unknown internal error of application.
IN

B.5.2 PID definition list

PID –patient information
I

Message example:
RU

PID|1||7393670||Liu Jia|||F|||||||||||||||||||||||25^Y
DI

Leng
No. Field name Description Examples
th
Identify different patient message
1 Set ID – PID 10 1
segments.
Patient Identifier
3# 16 Medical record number. 7393670
List
Liu Jia(Chinese name)
5# Patient Name 50 The name of the patient. String
Joan^Jiang(English name)^
F, M and O respectively indicates
Male, send M; female, send F; others, Female;
8 Sex 1
send O. Male;
Other.
Age and age units. Separate the age
from the age unit with ^. Where age is
an integer and length is 3. The age unit
31 Patient Age 5 25^Y
is a string with a length of 1, Y is sent
for age, M is sent for month, D is sent
for day, and H is sent for hour

B.5.3 PV1 definition list

B-4
 User Manual

PV1 –Patient consultation info.

Message example:
PV1|1||internal medicine|||||||||||||||||at one’s own expense
No. Field name Length Description Examples
Sequence number, used to identify different
1 Set ID - PV1 4 1
PV1 message segments in the message.
Assigned
Patient location information, expressed as
3 Patient 16 Outpatient
“Department”.
Location
Financial
20 16 Charge type, string, content without limit At one’s own expense
Class

B.5.4 OBR definition list

OBR - Inspection report information: This message section is optional and mainly contains inspection report
information, including sample numbers, inspection time, and so on.
Message example:
OBR||23|31C3F010230DFB03|1001^CountResults||20071207080000|20071207160000||||||
|20071207083000||||2311|322<cr>

D
LT
No. Field name Length Description Examples

.,
1 Set ID – OBR 10 Determine different OBR fields. 1
Requester’s medical order number, used as
2
Placer Order
Number
32 CO
the sample barcode number.
Bar code ID number in sample test
1A2165C24B
LJ/X quality control is lot number
Executor order number, used as sample
AL

Filler Order
3 12 number. Sample number in sample test; 20090807011
Number
File number in LJ/X quality control
I

Universal Service Universal service identifier. Identification

TR

4# 200 1001^CountResults
ID code + name
Requested Request time/date. Sampling time in sample
S

6 26 20090807140600
Date/time test; valid period in LJ/X quality control
DU

Observation date/time, used as test

date/time.
Observation
IN

7 26 Counting time in sample information; 20090807150616

Date/Time
Counting time in LJ/X quality control;
Counting time in X-B quality control.
I

Collector Collector identification. Indicating the

10 16 Dr
RU

Identifier sender
Specimen
14 Received 26 Test sending date/time. 20090807150000
DI

Date/Time
Attending doctor, used as a test doctor.
20 Filler Field 1 50 Dr
Operator in Lj Quality Control
28 Result Copies To 50 Result carbon copy. For reviewers. Dr

B.5.5 OBX definition list

OBX -Test result: repeatable, mainly including the test result parameters, analysis modes, reference groups, etc.
Message example:
OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00|L|||F||E
No. Field name Length Description Examples
1 Set ID – OBX 10 Identify different OBX fields. 6
Value type. The types used to identify the test
2 Value Type 3 NM
result are “ST”, “NM”, “ED”, “IS”, etc.

B-5
 User Manual

No. Field name Length Description Examples

Test item identification. The form is “ID^Name”,
ID is the test item identification, and Name is the
test item description information. For the code
Observation value of each test item, please refer to the
3# 20 2007^V_WBC
Identifier appendix: Identifier code definition. Note: ID is
used to uniquely determine a test parameter,
while Name is mainly used for description and
cannot be used as an identifier.
Test result data can be numbers, strings,
enumeration values, binary data, etc. [binary
4.63
data such as histograms and scatter plots are
5 Observation Value 65535
converted using Base64 encoding]
Xbar-R 5.5^1.1
Remark: Xbar-R quality control data format is
mean^range
Unit, used as the unit of the test result value. It is
6 Units 12 10*9/L
expressed in ISO standard units. 10\S\9/L
Reference range, normal range of test result
7 References Range 30 11.00-12.00
value.
Abnormal flag, check whether the result is
normal (description)

D
“N”-Normal

LT
“A”-abnormal
“H”-result is above the upper limit of the

8 Abnormal Flags
.,
reference range
5 “L”-result is below the lower limit of the L
reference range
CO
Note: This field may have abnormal signs or
high and low alarm signs at the same time. At
this time, multiple signs are connected with “~”,
AL

such as “H ~ A”.
This flag is not used during transmission.
I

Observe the result status.

Observe Result
TR

11# 1 The value is “F”-(Final Result), which represents F

Status
the final result.
S

User-defined access checks for use as original

DU

results.
Custom content, which is used to store reagent
expiry signs and modification signs. The format is
IN

“Mark 1 ~ Mark 2”.

There are three types of flags:
O-reagent expired flag
I

User Defined
13 16 E-active edit results flag E
RU

Access Checks
e-passive editing result flag
T-instrument temperature over-temperature
DI

C-results are marked for correction, DMU interface,

shown as”&”
V-exceeds linear range, DMU interface is displayed
as “@”
This flag is not used during transmission.

B.5.6 ORC definition list

ORC-Message segment mainly contains Order-related information.
Message example:
ORC|RF||SampleID||IP
No. Field name Length Description Examples
Order control word. Value: RF in ORM, which
1# Order Control 2 means request; AF in ORR message, which RF
means confirmation
Order initiator number
Placer Order
2 12 ORM message is empty; sample number in ORR
Number
message

B-6
 User Manual

No. Field name Length Description Examples

Recipient number of Order
Filler
3 12 Sample number in ORM message; ORR SampleID
OrderNum
message is empty
The value in the ORM information of the work
order query is fixed to IP, indicating that Order is
5 Order Status 2 IP
being processed and the result has not been
obtained; the value in the ORR is empty.

B.6 OBR-4 coding definition

Code Name Description OBR-4 field
1001 Count Results Sample count results 1001^ CountResults
1002 LJ QC L-J QC count results 1002^LJQC
1003 Xbar QC Xbar QC count results 1003^XbarQC
1004 XB QC X-B QC count results 1004^XBQC
1005 CRP QC CRP QC count results 1005^CRPQC

D
1006 XbarR QC Xbar-R QC count results 1006^XbarRQC

LT
B.7 OBX-3 identifier code definition

.,
Code Name Description Value type OBX-3 FIELD
2001 MODE Analysis mode CO
IS 2001^MODE
2002 MODE_EX Measurement mode IS 2002^MODE_EX
AL

2003 Ref Reference group IS 2003^Ref

2004 Note Remarks ST 2004^Note
I
TR

L-J/Xbar/Xbar-R/CRP QC
2005 Level IS 2005^Level
level
S

Total number of white blood

2006 V_WBC NM 2006^V_WBC
cell
DU

2007 V_NEU_p Percentage of neutrophil NM 2007^V_NEU_p

IN

2008 V_LYM_p Percentage of lymphocyte NM 2008^V_LYM_p

2009 V_MON_p Percentage of monocyte NM 2009^V_MON_p
I

2010 V_EOS_p Percentage of eosinophil NM 2010^V_EOS_p

RU

2011 V_BAS_p Percentage of basophil NM 2011^V_BAS_p

DI

2012 V_NEU_c Number of neutrophil NM 2012^V_NEU_c

2013 V_LYM_c Number of lymphocyte NM 2013^V_LYM_c
2014 V_MON_c Number of monocyte NM 2014^V_MON_c
2015 V_EOS_c Number of eosinophil NM 2015^V_EOS_c
2016 V_BAS_c Number of basophil NM 2016^V_BAS_c
2017 V_RBC Number of red blood cell NM 2017^V_RBC
2018 V_HGB Hemoglobin NM 2018^V_HGB
2019 V_MCV Mean red blood cell volume NM 2019^V_MCV
2020 V_HCT RBC hematocrit NM 2020^V_HCT
Mean red blood cell
2021 V_MCH NM 2021^V_MCH
hemoglobin content
Mean red blood cell
2022 V_MCHC NM 2022^V_MCHC
hemoglobin concentration

B-7
 User Manual

Code Name Description Value type OBX-3 FIELD

Standard deviation of red
2023 V_RDW_SD NM 2023^V_RDW_SD
blood cell distribution width
Red blood cell distribution
2024 V_RDW_CV NM 2024^V_RDW_CV
width variation coefficient
2025 V_PLT Number of platelet NM 2025^V_PLT
2026 V_MPV Average platelet volume NM 2026^V_MPV
2027 V_PCT Platelet hematocrit NM 2027^V_PCT
2028 V_PDW Platelet distribution width NM 2028^V_PDW
2029 V_P_LCR Platelet-large cell ratio NM 2029^V_P_LCR
2030 V_P_LCC Platelet-large cell count NM 2030^V_ P_LCC
2031 V_CRP C reactive protein NM 2031^V_CRP
Hypersensitive C-reactive
2032 V_HS_CRP ST 2032^V_HS_CRP
protein
RBC histogram PNG data
Remark: in transmission
RBC

D
2101 from median computer to ED 2101^RBC Scattergram.PNG
Histogram.PNG

LT
LIS, the picture format is
PNG
PLT histogram PNG data

.,
Remark: in transmission
PLT
2102 from median computer to ED 2102^PLT Scattergram.PNG
Histogram.PNG
LIS, the picture format is
PNG
CO
BASO scattergram PNG
AL

data
BASO Remark: in transmission
2033 ED 2033^BASO Scattergram.PNG
I

Scattergram.PNG from median computer to

TR

LIS, the picture format is

PNG
S

DIFF scattergram PNG data

Remark: in transmission
DU

DIFF
2034 from median computer to ED 2034^DIFF Scattergram.PNG
Scattergram.PNG
LIS, the picture format is
IN

PNG
Original data
Remark: used in
2035 Dat1 data ED 2035^Dat1
I

transmission from median

RU

computer to host computer

Original data
DI

Remark: used in
2036 Dat2 data ED 2036^Dat2
transmission from median
computer to host computer
Original data
Remark: used in
2037 Dat3 data ED 2037^Dat3
transmission from median
computer to host computer
Original data
Remark: used in
2038 Dat4 data ED 2038^Dat4
transmission from median
computer to host computer

obx_value_type = {“2001^MODE”, “2002^MODE_EX”, “2003^Ref”,

“2004^Note”, “2005^Level”, “2006^V_WBC”,”2007^V_NEU_p”,
“2008^V_LYM_p”,”2009^V_MON_p”,”2010^V_EOS_p”, “2011^V_BAS_p”,
“2012^V_NEU_c”, “2013^V_LYM_c”, “2014^V_MON_c”,”2015^V_EOS_c”,”2016^V_BAS_c”,
“2017^V_RBC”, “2018^V_HGB”, “2019^V_MCV”,”2020^V_HCT”,
“2021^V_MCH”, “2022^V_MCHC”, “2023^V_RDW_SD”,”2024^V_RDW_CV”,
“2025^V_PLT”, “2026^V_MPV”, “2027^V_PDW”,

B-8
 User Manual

“2028^V_PCT”, “2029^V_P_LCR”, “2030^V_P_LCC”,”2031^V_CRP”,”2101^RBC

Scattergram.BMP”,”2102^PLT Scattergram.BMP”,
“2033^BASO Scattergram.BMP”,”2034^DIFF Scattergram.BMP”, “2079^XB_Num”
list[0] = refence.wbcU;
list[1] = refence.rbcU;
list[2] = refence.hgbU;
list[3] = refence.hctU;
list[4] = refence.mcvU;
list[5] = refence.mchU;
list[6] = refence.mchcU;
list[7] = refence.pltU;
list[8] = refence.rdwSDU;
list[9] = refence.rdwCVU;
list[10] = refence.pdwU;
list[11] = refence.mpvU;

D
list[12] = refence.plcrU;

LT
list[13] = refence.plcrsU;

.,
list[14] = refence.pctU;
list[15] = refence.neuCU; CO
list[16] = refence.lymCU;
list[17] = refence.monCU;
AL

list[18] = refence.eosCU;
I

list[19] = refence.basCU;
TR

list[20] = refence.neuPU;
S

list[21] = refence.lymPU;
DU

list[22] = refence.monPU;
list[23] = refence.eosPU;
IN

list[24] = refence.basPU;
list[25] = refence.crpU;
I
RU

B.8 Enumeration type list

Data item Value
DI

0-Whole blood/Closed whole blood 1-Trace whole blood 2-Predilution 3-Automatic whole
Analysis mode
blood
Measurement mode 0- CBC 1-CBC+DIFF 2-CBC+DIFF+CRP 3-CRP 4-CBC+CRP
0 - Normal 1 - Male 2 - Female 3 - Child 4 - Newborn 5 -Self-defined 16- Self-defined 27
Reference group -Self-defined 38 -Self-defined 4
9 -Self-defined 5
QC level 0-high 1-middle 2-low

Example of a complete message section:

(1)Patient sample
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153322||ORU^R01|3|P|2.3.1||||||UTF-8<cr>
PID|1|||||||U|||||||||||||||||||||||1^Y<cr>
PV1|1|||||||||||||||||||<cr>
OBR|1||5|1001^CountResults||20180601091634|20180601091637|||||||20180601091634||||||---||||||||<cr>
OBX|1|IS|2001^MODE||0||||||F||<cr>

B-9
 User Manual

OBX|2|IS|2002^MODE_EX||1||||||F||<cr>
OBX|3|IS|2003^Ref||0||||||F||<cr>
OBX|4|IS|2004^Note||||||||F||<cr>
OBX|5|NM|2006^V_WBC||0|10^9/L|4-10||||F||<cr>
OBX|6|NM|2007^V_NEU_p||0|%|50-70||||F||<cr>
OBX|7|NM|2008^V_LYM_p||0|%|20-40||||F||<cr>
OBX|8|NM|2009^V_MON_p||0|%|3-8||||F||<cr>
OBX|9|NM|2010^V_EOS_p||0|%|0.5-5||||F||<cr>
OBX|10|NM|2011^V_BAS_p||0|%|0-1||||F||<cr>
OBX|11|NM|2012^V_NEU_c||0|10^9/L|2-7||||F||<cr>
OBX|12|NM|2013^V_LYM_c||0|10^9/L|0.8-4||||F||<cr>
OBX|13|NM|2014^V_MON_c||0|10^9/L|0.12-0.8||||F||<cr>
OBX|14|NM|2015^V_EOS_c||0|10^9/L|0.02-0.5||||F||<cr>
OBX|15|NM|2016^V_BAS_c||0|10^9/L|0-0.1||||F||<cr>
OBX|16|NM|2017^V_RBC||0|10^12/L|3.5-5.5||||F||<cr>

D
LT
OBX|17|NM|2018^V_HGB||1|g/L|110-160||||F||<cr>
OBX|18|NM|2019^V_MCV||0|fL|80-100||||F||<cr>

.,
OBX|19|NM|2020^V_HCT||0|L/L|0.35-0.5||||F||<cr>
OBX|20|NM|2021^V_MCH||0|pg|27-34||||F||<cr>
OBX|21|NM|2022^V_MCHC||0|g/L|320-360||||F||<cr>
CO
OBX|22|NM|2023^V_RDW_SD||0|fL|35-56||||F||<cr>
AL

OBX|23|NM|2024^V_RDW_CV||0|%|11-16||||F||<cr>
I

OBX|24|NM|2025^V_PLT||0|10^9/L|100-300||||F||<cr>
TR

OBX|25|NM|2026^V_MPV||0|fL|7-13||||F||<cr>
S

OBX|26|NM|2027^V_PCT||0|%|0.1-0.28||||F||<cr>
DU

OBX|27|NM|2028^V_PDW||0|fL|15-18||||F||<cr>
IN

OBX|28|NM|2029^V_P_LCR||0|%|13-43||||F||<cr>
OBX|29|NM|2030^V_P_LCC||0|10^9/L|13-129||||F||<cr>
OBX|30|NM|2031^V_CRP||0|mg/L|0-6||||F||<cr>
I
RU

OBX|31|ST|2032^V_HS_CRP||0.00|mg/L|0-6||||F||<cr>
OBX|32|ED|2101^V_RBCScattergram.PNG||……PNG binary data converted into BASE64 coding……||||||F||<cr>
DI

OBX|33|ED|2102^V_PLTScattergram.PNG||……PNG binary data converted into BASE64 coding……||||||F||<cr>

OBX|34|ED|2033^V_BASOScattergram.PNG||……PNG binary data converted into BASE64
coding……||||||F||<cr>
OBX|35|ED|2034^V_DIFFScattergram.PNG||……PNG binary data converted into BASE64
coding……||||||F||<cr>
<EB><CR>
Special instructions:
When the median computer sends sample results to LIS, all items are sent by default. The LIS terminal needs to
filter and display according to different measurement modes and the items of concern. The following shows the
default display items in different measurement modes.
Measurement mode 2002^MODE_EX
Code Name OBX-3 FIELD 1-CBC 2-CBC+DIFF 4-CBC
0-CBC 3-CRP
+DIFF +CRP +CRP
2006 V_WBC 2006^V_WBC √ √ √ × √

B-10
 User Manual

Measurement mode 2002^MODE_EX

Code Name OBX-3 FIELD 1-CBC 2-CBC+DIFF 4-CBC
0-CBC 3-CRP
+DIFF +CRP +CRP
2007 V_NEU_p 2007^V_NEU_p × √ √ × ×
2008 V_LYM_p 2008^V_LYM_p × √ √ × ×
2009 V_MON_p 2009^V_MON_p × √ √ × ×
2010 V_EOS_p 2010^V_EOS_p × √ √ × ×
2011 V_BAS_p 2011^V_BAS_p × √ √ × ×
2012 V_NEU_c 2012^V_NEU_c × √ √ × ×
2013 V_LYM_c 2013^V_LYM_c × √ √ × ×
2014 V_MON_c 2014^V_MON_c × √ √ × ×
2015 V_EOS_c 2015^V_EOS_c × √ √ × ×
2016 V_BAS_c 2016^V_BAS_c × √ √ × ×
2017 V_RBC 2017^V_RBC √ √ √ × √

D
LT
2018 V_HGB 2018^V_HGB √ √ √ × √
2019 V_MCV 2019^V_MCV √ √ √ × √

.,
2020 V_HCT 2020^V_HCT √ √ √ × √
2021 V_MCH 2021^V_MCH √ √ CO √ × √
2022 V_MCHC 2022^V_MCHC √ √ √ × √
AL

2023^V_RDW_S
2023 V_RDW_SD √ √ √ × √
D
I

2024^V_RDW_C
2024 V_RDW_CV √ √ √ × √
TR

V
2025 V_PLT 2025^V_PLT √ √ √ × √
S
DU

2026 V_MPV 2026^V_MPV √ √ √ × √

2027 V_PCT 2027^V_PCT √ √ √ × √
IN

2028 V_PDW 2028^V_PDW √ √ √ × √

2029 V_P_LCR 2029^V_P_LCR √ √ √ × √
I
RU

2030 V_P_LCC 2030^V_ P_LCC √ √ √ × √

2031 V_CRP 2031^V_CRP × × √ √ √
DI

2032 V_HS_CRP 2032^V_HS_CRP × × √ √ √

RBC
2101^RBC
2101 Histogram.P √ √ √ × √
Scattergram.PNG
NG
PLT
2102^PLT
2102 Histogram.P √ √ √ × √
Scattergram.PNG
NG
BASO
2033^BASO
2033 Scattergram. √ √ √ × √
Scattergram.PNG
PNG
DIFF
2034^DIFF
2034 Scattergram. × √ √ × ×
Scattergram.PNG
PNG

(2)L-J QC
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153445||ORU^R01|5|Q|2.3.1||||||UTF-8<cr>
PID|1||||||||||||||||||||||||||||||^<cr>
PV1|1|||||||||||||||||||<cr>

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 User Manual

OBR|1|||1||1002^LJQC|20180420|||20180420113307||||||||||||||||||<cr>
OBX|1|IS|2005^Level||1||||||F||<cr>
OBX|2|NM|2006^V_WBC||465.11|10^9/L|490-510||||F||<cr>
OBX|3|NM|2007^V_NEU_p||0|%|0-0||||F||<cr>
OBX|4|NM|2008^V_LYM_p||0|%|0-0||||F||<cr>
OBX|5|NM|2009^V_MON_p||0|%|0-0||||F||<cr>
OBX|6|NM|2010^V_EOS_p||0|%|0-0||||F||<cr>
OBX|7|NM|2011^V_BAS_p||0|%|0-0||||F||<cr>
OBX|8|NM|2012^V_NEU_c||0|10^9/L|0-0||||F||<cr>
OBX|9|NM|2013^V_LYM_c||0|10^9/L|0-0||||F||<cr>
OBX|10|NM|2014^V_MON_c||0|10^9/L|0-0||||F||<cr>
OBX|11|NM|2015^V_EOS_c||0|10^9/L|0-0||||F||<cr>
OBX|12|NM|2016^V_BAS_c||0|10^9/L|0-0||||F||<cr>
OBX|13|NM|2017^V_RBC||3.94|10^12/L|0-0||||F||<cr>
OBX|14|NM|2018^V_HGB||110|g/L|0-0||||F||<cr>

D
LT
OBX|15|NM|2019^V_MCV||87.6|fL|0-0||||F||<cr>
OBX|16|NM|2020^V_HCT||0.345|L/L|0-0||||F||<cr>

.,
OBX|17|NM|2021^V_MCH||27.9|pg|0-0||||F||<cr>
OBX|18|NM|2022^V_MCHC||319|g/L|0-0||||F||<cr>
OBX|19|NM|2023^V_RDW_SD||51.2|fL|0-0||||F||<cr>
CO
OBX|20|NM|2024^V_RDW_CV||15|%|0-0||||F||<cr>
AL

OBX|21|NM|2025^V_PLT||135|10^9/L|0-0||||F||<cr>
I

OBX|22|NM|2026^V_MPV||12.2|fL|0-0||||F||<cr>
TR

OBX|23|NM|2027^V_PCT||0.165|%|0-0||||F||<cr>
S

OBX|24|NM|2028^V_PDW||19.2|fL|0-0||||F||<cr>
DU

OBX|25|NM|2029^V_P_LCR||42.5|%|0-0||||F||<cr>
IN

<EB><CR>
(3)XBar QC data sending
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153445||ORU^R01|5|Q|2.3.1||||||UTF-8<cr>
I
RU

PID|1||||||||||||||||||||||||||||||^<cr>
PV1|1|||||||||||||||||||<cr>
DI

OBR|1|||1||1003^XbarQC|20180420|||20180420113307||||||||||||||||||<cr>
OBX|1|IS|2005^Level||1||||||F||<cr>
OBX|2|NM|2006^V_WBC||465.11|10^9/L|490-510||||F||<cr>
OBX|3|NM|2007^V_NEU_p||0|%|0-0||||F||<cr>
OBX|4|NM|2008^V_LYM_p||0|%|0-0||||F||<cr>
OBX|5|NM|2009^V_MON_p||0|%|0-0||||F||<cr>
OBX|6|NM|2010^V_EOS_p||0|%|0-0||||F||<cr>
OBX|7|NM|2011^V_BAS_p||0|%|0-0||||F||<cr>
OBX|8|NM|2012^V_NEU_c||0|10^9/L|0-0||||F||<cr>
OBX|9|NM|2013^V_LYM_c||0|10^9/L|0-0||||F||<cr>
OBX|10|NM|2014^V_MON_c||0|10^9/L|0-0||||F||<cr>
OBX|11|NM|2015^V_EOS_c||0|10^9/L|0-0||||F||<cr>
OBX|12|NM|2016^V_BAS_c||0|10^9/L|0-0||||F||<cr>

B-12
 User Manual

OBX|13|NM|2017^V_RBC||3.94|10^12/L|0-0||||F||<cr>
OBX|14|NM|2018^V_HGB||110|g/L|0-0||||F||<cr>
OBX|15|NM|2019^V_MCV||87.6|fL|0-0||||F||<cr>
OBX|16|NM|2020^V_HCT||0.345|L/L|0-0||||F||<cr>
OBX|17|NM|2021^V_MCH||27.9|pg|0-0||||F||<cr>
OBX|18|NM|2022^V_MCHC||319|g/L|0-0||||F||<cr>
OBX|19|NM|2023^V_RDW_SD||51.2|fL|0-0||||F||<cr>
OBX|20|NM|2024^V_RDW_CV||15|%|0-0||||F||<cr>
OBX|21|NM|2025^V_PLT||135|10^9/L|0-0||||F||<cr>
OBX|22|NM|2026^V_MPV||12.2|fL|0-0||||F||<cr>
OBX|23|NM|2027^V_PCT||0.165|%|0-0||||F||<cr>
OBX|24|NM|2028^V_PDW||19.2|fL|0-0||||F||<cr>
OBX|25|NM|2029^V_P_LCR||42.5|%|0-0||||F||<cr>
<EB><CR>
(4)XBar-R QC data sending

D
LT
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153516||ORU^R01|6|Q|2.3.1||||||UTF-8<cr>
PID|1||||||||||||||||||||||||||||||^<cr>

.,
PV1|1|||||||||||||||||||<cr>
CO
OBR|1|||1||1006^XbarRQC|20180420|||20180420124717||||||||||||||||||<cr>
OBX|1|IS|2005^Level||1||||||F||<cr>
OBX|2|NM|2006^V_WBC||739.805^512.27|10^9/L|||||F||<cr>
AL

OBX|3|NM|2007^V_NEU_p||0^0|%|||||F||<cr>
I

OBX|4|NM|2008^V_LYM_p||0^0|%|||||F||<cr>
TR

OBX|5|NM|2009^V_MON_p||0^0|%|||||F||<cr>
S

OBX|6|NM|2010^V_EOS_p||0^0|%|||||F||<cr>
DU

OBX|7|NM|2011^V_BAS_p||0^0|%|||||F||<cr>
IN

OBX|8|NM|2012^V_NEU_c||0^0|10^9/L|||||F||<cr>
OBX|9|NM|2013^V_LYM_c||0^0|10^9/L|||||F||<cr>
OBX|10|NM|2014^V_MON_c||0^0|10^9/L|||||F||<cr>
I
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OBX|11|NM|2015^V_EOS_c||0^0|10^9/L|||||F||<cr>
OBX|12|NM|2016^V_BAS_c||0^0|10^9/L|||||F||<cr>
DI

OBX|13|NM|2017^V_RBC||5.79^0.0799999|10^12/L|||||F||<cr>
OBX|14|NM|2018^V_HGB||157.5^3|g/L|||||F||<cr>
OBX|15|NM|2019^V_MCV||80.2^0.200005|fL|||||F||<cr>
OBX|16|NM|2020^V_HCT||0.4645^0.005|L/L|||||F||<cr>
OBX|17|NM|2021^V_MCH||27.15^0.700001|pg|||||F||<cr>
OBX|18|NM|2022^V_MCHC||339^8|g/L|||||F||<cr>
OBX|19|NM|2023^V_RDW_SD||38.4^0|fL|||||F||<cr>
OBX|20|NM|2024^V_RDW_CV||13.3^0|%|||||F||<cr>
OBX|21|NM|2025^V_PLT||241.5^25|10^9/L|||||F||<cr>
OBX|22|NM|2026^V_MPV||11.15^1.3|fL|||||F||<cr>
OBX|23|NM|2027^V_PCT||0.2705^0.057|%|||||F||<cr>
OBX|24|NM|2028^V_PDW||15.2^3.6|fL|||||F||<cr>
OBX|25|NM|2029^V_P_LCR||33.55^8.5|%|||||F||<cr>

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 User Manual

<EB><CR>
(5)X-B QC data sending
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153529||ORU^R01|7|Q|2.3.1||||||UTF-8<cr>
PID|1||||||||||||||||||||||||||||||^<cr>
PV1|1|||||||||||||||||||<cr>
OBR|1|||||1004^XBQC||||20180426110445||||||||||||||||||<cr>
OBX|1|NM|2019^V_MCV||97.245|fL|60-100||||F||<cr>
OBX|2|NM|2021^V_MCH||30.735|pg|0-87||||F||<cr>
OBX|3|NM|2022^V_MCHC||316.4|g/L|280-320||||F||<cr>
<EB><CR>
(6)CRP QC data sending
<SB>MSH|^~&|BF-6900||LIS||20190822095204||ORU^R01|4|Q|2.3.1||||||UTF-8<cr>
PID|1||||||||||||||||||||||||||||||^<cr>
PV1|1|||||||||||||||||||<cr>
OBR|1|122|1|1005^CRPQC||20190802|20190802134916|||||||||||||||||||||<cr>

D
LT
OBX|1|IS|2005^Level||0||||||F||<cr>
OBX|2|NM|2031^V_CRP||0.03|mg/L|0-2||||F||<cr>

.,
<EB><CR>
(7)Work order application CO
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153408||ORM^O01|4|P|2.3.1||||||UTF-8<cr>
ORC|RF||218||IP<cr>
AL

<EB><CR>
I

(8)Work order obtaining

TR

<SB>MSH|^~\&|LIS||||20180613154025||ORR^O02|4|P^S|2.3.1||||||UTF8<cr>
S

MSA|AA|1||||0<cr>
DU

PID|1||5||T5|||M|||||||||||||||||||||||3^Y<cr>
IN

PV1|1||Orthopedics|||||||||||||||||Medical insurance<cr>
ORC|AF|218|||<cr>
OBR|1|218|5|1001^Count ||20180613153909||||Gu Yisheng||||20180613153919||||||||||||||<cr>
I
RU

OBX|1|IS|2001^MODE||0||||||||<cr>
OBX|2|IS|2002^MODE_EX||0||||||||<cr>
DI

OBX|3|IS|2003^Ref||0||||||||<cr>
OBX|4|ST|2004^Note||test||||||||<cr>
<EB><CR>
(9)Sample and quality control response
<SB>MSH|^~\&|LIS||||20190819160739||ACK^R01|2|P|2.3.1||||||UTF8<cr>
MSA|AA|1||||0<cr>
<EB><CR>

B-14
 User Manual

Appendix C Product description

C.1 Product classification
According to Product Classification Catalog of Medical Devices:
The Analyzer is a blood analyzer belonging to clinical analyzers (6840), and the management class is Class II.
C.2 Product matching reagent
(1)BF-5D diluent
(2)BF-FDT I lyse
(3)BF- FBH lyse
(4)BF-FDO I lyse
(5)BF-CRP lyse
(6)C-reactive protein test kit
C.3 Consumption of product matching reagent
Necessary operations of the instrument Consumption

D
Sleep (not used for 2 hours) BF-5D diluent 61mL

LT
Wake BF-5D diluent 85mL

.,
BF-5D diluent 107mL
Manual washing capability
CO
Probe cleanser
BF-5D diluent
4mL
107mL
Automatic rinsing of equipment (setting times of 10-200)
AL

Probe cleanser 4mL

BF-5D diluent 194mL
I
TR

BF-FDOⅠ lyse 1mL

Turn-on
BF-FDTⅠ lyse 0.12mL
S
DU

BF-FBH lyse 3.1mL

IN

BF-5D diluent 102mL

Turn-off
Probe cleanser 4mL
I
RU

Operations of the instrument during servicing Consumption

DI

Rinse WBC cell BF-5D diluent 9mL

Rinse RBC cell BF-5D diluent 13mL
Rinse sheath flow cell BF-5D diluent 14mL
Rinse sample-aspirating probe BF-5D diluent 12mL
Rinse CRP1 reaction cell BF-5D diluent 14mL
Rinse CRP2 reaction cell BF-5D diluent 14mL
Unblocking BF-5D diluent 9mL
Back washing BF-5D diluent 9mL
BF-5D diluent 13mL
Soak WBC
Probe cleanser 0.7mL
BF-5D diluent 20mL
Soak RBC
Probe cleanser 2.3mL

C-1
 User Manual

Operations of the instrument during servicing Consumption

BF-5D diluent 25mL
Soak sheath flow cell
Probe cleanser 4mL
BF-5D diluent 19mL
Soak CRP1 cell
Probe cleanser 1mL
BF-5D diluent 19mL
Soak CRP2 cell
Probe cleanser 1mL

Operations of the instrument during

Reagent volume for filling/rinsing pipes
servicing
BF-5D diluent 9mL
Fill BF-FDOⅠ lyse (after drainage)
BF-FDOⅠ lyse 10mL
BF-5D diluent 9mL
Fill BF-FDTⅠ lyse (after drainage)

D
BF-FDTⅠ lyse 5mL

LT
BF-5D diluent 9mL
Fill BF-FBH lyse (after drainage)

.,
BF-FBH lyse 10mL
Fill BF-5D diluent (after drainage) BF-5D diluent 159mL
BF-5D diluent
CO 9mL
Replace BF-FDOⅠ lyse
BF-FDOⅠ lyse 10mL
AL

BF-5D diluent 9mL

I

Replace BF-FDTⅠ lyse BF-FDTⅠ lyse 5mL

TR

BF-FDOⅠ lyse 2mL

S

BF-5D diluent 9mL

DU

Replace BF-FBH lyse

BF-FBH lyse 9mL
IN

Replace BF-5D diluent BF-5D diluent 159mL

BF-CRP lyse 12mL
I

Fill BF-CRP lyse (after drainage)

RU

BF-5D diluent 6mL

BF-CRP lyse 12mL
DI

Replace BF-CRP lyse (after drainage)

BF-5D diluent 6mL

Reagent consumption for one-time test

BF-5D diluent (whole-blood) 64mL
BF-FBH lyse 0.6mL
BF-FDOⅠ lyse 0.5mL
BF-FDTⅠ lyse 0.12mL
BF-CRP lyse 0.6mL
C-reactive protein reagent 0.22mL

C-2
 User Manual

C.4 Description of parameters

(1)Parameters from scattergram/histogram

Name Abbreviations Default unit

Percentage of lymphocyte LYM% %

Percentage of monocyte MON% %

Percentage of basophil BAS% %

Percentage of eosinophil EOS% %

Mean red blood cell volume MCV fL

Red blood cell distribution width
RDW-CV %
variation coefficient
Red blood cell distribution width
RDW-SD fL
deviation limit
Average platelet volume MPV fL

D
Platelet distribution width PDW %

LT
(2)Parameter from calculation

.,
Name Abbreviations Default unit
Percentage of neutrophil NEU%
CO %
Number of lymphocyte LYM# 109／L
AL

Number of monocyte MON# 109／L

I

Number of neutrophil NEU# 109／L

TR

Number of basophil BAS# 109／L

S

Number of eosinophil EOS# 109／L

DU

RBC hematocrit HCT L ／L

IN

Mean red blood cell hemoglobin content MCH pg

Mean red blood cell hemoglobin
MCHC g／L
concentration
I
RU

Platelet hematocrit PCT %

DI

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 User Manual

Appendix D Performance indexes

D.1 Blank counting
(1)RBC≤0.02×1012/L；
(2)WBC≤0.2×109/L；
(3)HGB≤1g/L；
(4)PLT≤5×109/L；
(5)FR-CRP≤0.1mg/L.
D.2 Linearity
The linear range and deviation of the Analyzer shall conform to Table D-2-1:
Table D-2-1 Linear requirements of the Analyzer
Linearly dependent
Parameters Linear range Allowable deviation range
coefficient (r)
(0~10.0)×109/L Not exceeding ±0.3×109/L
WBC (10.1~100.0)×109/L Not exceeding ±5.0% ≥0.990

D
9

LT
(100.1~500.0)×10 /L Not exceeding ±10.0%
12
(0~1.00)×10 /L Not exceeding ±0.03×1012/L

.,
RBC ≥0.990
(1.01~8.00)×1012/L Not exceeding ±3.0%

HGB
(0~70) g/L
(71~240) g/L
CO
Not exceeding ±2.0g/L
Not exceeding ±2.0%
≥0.990

(0~100)×109/L Not exceeding ±10.0×109/L

AL

PLT (101~1000)×109/L Not exceeding ±5.0% ≥0.990

I

9/
(1001~5000)×10 L Not exceeding ±10.0%
TR

(0.2~10.0)mg/L Not exceeding ±1.0mg/l

S

FR-CRP ≥0.990
(10.1~320)mg/L Not exceeding ±15.0%
DU

D.3 Precision
IN

The precision of the Analyzer shall conform to Table D-3-1.

Table D-3-1 Requirements on precision of the Analyzer
I
RU

Parameters Detection range Precision

9
(3.5~9.5)×10 /L ≤2.5%
DI

WBC 9
(9.6~15.0)×10 /L ≤2.5%
12
(3.50~5.50)×10 /L ≤1.5%
RBC 12
(5.51~6.50)×10 /L ≤1.5%
(110~160) g/L ≤1.5%
HGB
(161~180) g/L ≤1.5%
9
(100~149)×10 /L ≤5.0%
PLT 9
(150~500)×10 /L ≤4.0%
HCT (30~50)% ≤1.5%
(70~100）fL ≤1.0%
MCV
(101~120）fL ≤1.0%
(2.0~10)mg/L ≤10.0%
FR-CRP
(10.1~320)mg/L ≤4.0%

D.4 Accuracy

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 User Manual

The accuracy deviation of the Analyzer shall conform to Table D-4-1:

Table D-4-1 Requirements on accuracy of the Analyzer

Parameters Detection range Allowable deviation range

9
WBC (3.5~9.5)×10 /L Not exceeding ±4.5%
RBC (3.80~5.80)×1012/L Not exceeding ±3.0%
HGB (115~175) g/L Not exceeding ±3.0%
9
PLT (125~350)×10 /L Not exceeding ±7.0%
(35~50)%(HCT)
HCT or MCV Not exceeding ±3.0%
Or (82~100)fL(MCV)
FR-CRP (10~100)mg/L Not exceeding ±15.0%

D.5 Accuracy of classification of white blood cell by the Analyzer

The test result of neutrophil, lymphocyte, monocyte, acidophil and basophil shall be limited in the allowable range
of the test method setting result of the Analyzer (99% credibility interval).
Note: if the reference test result is 0 and the result of the Analyzer is ≤1.0%, the test result is also acceptable.

D
D.6 Carrying pollution rate

LT
The carrying pollution rate of the Analyzer shall meet the following requirements:

.,
(1)RBC≤0.5%.
(2)WBC≤0.5%.
(3)HGB≤0.5%.
CO
(4)PLT≤0.5%.
AL

(5)FR-CRP≤1.0%.
I
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IN
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 User Manual

Appendix E Parts list

Parts list (including parts, accessories and consumables)
Replacement Replacement
Part name Location Remarks
cycle method
Please contact This part can be
Sample-aspirating Sample-aspirating Test of 30,000
customer service checked/replaced by the
syringe pump syringe unit samples
personnel manufacturer/agency only
Please contact This part can be
Sheath syringe Test of 30,000
Sheath syringe unit customer service checked/replaced by the
pump samples
personnel manufacturer/agency only
Please contact This part can be
BF-FDOⅠ Test of 30,000
Sheath syringe unit customer service checked/replaced by the
syringe pump samples
personnel manufacturer/agency only
Please contact This part can be
BF-FBH syringe Test of 30,000
Rinse syringe unit customer service checked/replaced by the
pump samples
personnel manufacturer/agency only
Please contact This part can be
Rinse syringe Test of 30,000
Rinse syringe unit customer service checked/replaced by the
pump samples
personnel manufacturer/agency only

D
Please contact This part can be

LT
CRP syringe Test of 30,000
CRP syringe unit customer service checked/replaced by the
pump samples
personnel manufacturer/agency only

.,
Please contact This part can be
Rinse syringe Test of 30,000
CRP syringe unit customer service checked/replaced by the
pump samples CO
personnel manufacturer/agency only
Sampling probe Sampling unit 100,000 samples 9.4.1
AL

3000 hours Please contact This part can be

Positive pressure
Pump unit (Continuous customer service checked/replaced by the
pump
I

work) personnel manufacturer/agency only

TR

2000 hours Please contact This part can be

Vacuum pump Pump unit (Continuous customer service checked/replaced by the
S

work) personnel manufacturer/agency only

DU

10,000/hour Please contact This part can be

W-B reaction cell
HGB light source (Continuous customer service checked/replaced by the
unit
work) personnel manufacturer/agency only
IN
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 User Manual

Appendix F Statement on electromagnetic compatibility

1. For requirements of immunity refer to Table F-1.
Table F-1 Requirements of Electromagnetic CompatibilityImmunity Test

Standard requirements

EMC Applicable Performance

Port Test items Test value
standard or not criterion

Electrostatic Air discharge: 2kV, 4kV, 8kV

IEC 61000-4-2 Applicable B
discharge (ESD) Contact discharge: 2kKV, 4kV

Radiated
electromagnetic IEC 61000-4-3 3V/m, 80MHz~2.0GHz, 80%AM Applicable A
Shell
fields

Rated
power-frequency IEC 61000-4-8 3A/m, 50Hz Applicable A

D
magnetic field

LT
0% for 1 cycle; B
IEC

.,
Voltage sag 40% for 5/6 cycles; Applicable B
61000-4-11
70% for 25/30 cycles C
Voltage
interruption
IEC
61000-4-11
CO
5%, duration: 250/300 cycles Applicable C
AL

AC power
Pulse train IEC 61000-4-4 1kV(5/50ns, 5kHz) Applicable B
supply
I
TR

Surge IEC 61000-4-5 Line to ground: 2kV/line to line: 1kV Applicable B

S

Radio-frequency
DU

IEC 61000-4-6 3V, 150kHz~80MHz, 80%AM Applicable A

conduction
IN

Not
Pulse train IEC 61000-4-4 1kV(5/50ns, 5kHz) --
applicable
I

DC power Line to ground: 2kV/line to ground: Not

RU

Surge IEC 61000-4-5 --

supply 1kV applicable
DI

Radio-frequency Not
IEC 61000-4-6 3V, 150kHz~80MHz, 80%AM --
conduction applicable

Not
Pulse train IEC 61000-4-4 0.5kV(5/50ns, 5kHz) --
applicable

Not
I/O signal Surge IEC 61000-4-5 None --
applicable

Radio-frequency
IEC 61000-4-6 3V, 150kHz~80MHz, 80%AM Applicable A
conduction

Not
Pulse train IEC 61000-4-4 1kV(5/50ns, 5kHz) --
applicable
I/O signal
Not
to main Surge IEC 61000-4-5 None --
applicable
power
Radio-frequency Not
IEC 61000-4-6 3V, 150kHz~80MHz, 80%AM --
conduction applicable

F-1
 User Manual

2. For emission test requirements refer to Table F-2.

Table F-2 Emission Test Items & Requirements

Applicable
Test items EMC standard Test value
or not
Pst value is not greater than 1.0; Plt value is not greater than 0.65;
duration ford(t) value exceeding 3.3% in voltage change period is
Voltage fluctuation
IEC 61000-3-3 nolonger than 500ms; change of relative steady-state voltage (dc) No
and flicker
does not exceed 3.3%; and relative maximum voltage change
(dmax) does not exceed 6%.

Harmonic current It is 1.5 times of the limit value specified in Table 1 of GB/T
IEC 61000-3-2 No
emission 17625.1.

Electromagnetic It meets the requirements on limit value of Class A and Group I

IEC/CISPR 11 Yes
interference equipment in GB4824.

3. Basic performance: “Blank count” indexes meet the requirements.

Statement on electromagnetic compatibility:

D
LT
● The manufacturer is responsible for providing the consumer/user with the info of electromagnetic
compatibility of the equipment.

.,
● The user is responsible for guaranteeing the environment for electromagnetic compatibility of the
equipment so that it can work normally.
CO
● The equipment meets the specified requirements on emission and immunity in IEC 61326.
● The equipment is designed and tested according to Class A equipment in IEC/CISPR 11. In home
AL

environment, the equipment may cause radio interference, thus preventive measures should be taken.
● It is recommended to evaluate electromagnetic environment before using the equipment.
I
TR

● It is forbidden to use the equipment beside any source of intense radiation, or it may interfere with normal
operation of the equipment.
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