bf-6500 automatic hematology analyzer user manual 1111

BF-6500 Automatic Hematology Analyzer User Manual

Instruction:

Dear user, thanks for choosing our BF-6500 Automatic Hematology Analyzer.

Please read the user manual carefully before use in order to operate the instrument correctly.

Please keep the user manual safely for your any time reference.

Warning:

●An independent power supply is a must. Electromagnetism interference will affect the accuracy

of the test result.

●Don‘t pull the electrical wire with wet hand, or there is a risk of electrical shock.

●Don't stamp, twist, drag the wire and cable, or it may cause a fire. The damaged wire and cable

can not be used.

●The instrument must be used in good grounding condition.

●The input power should conform to instrument requirement. Specified fuse should be used.

●Make sure the switch is on [O] state before connecting the power.

●It can not be used in flammable and explosive environment.

●DO NOT touch moving parts when the instrument is testing to avoid accident.

●Non-professionals can not open the left, right and upper cover of the instrument when the main

power is ON.

●Make sure the instrument is used under the condition that is specified in user manual. In

improper condition, the instrument may not work well, the result may be inaccurate, instrument

component may be damaged and personal security is endangered.

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Note:

● Instrument should be operated by medical inspection specialist, physician, nurse or lab

assistant whom are specially trained.

● Maintenance plan of hospitals and inspecton bodies should be prepared and followed.

● Instrument should be controlled by special software specified by DIRUI. Other hardware or

software installation may affect the normal working of the instrument.

●Expired reagent can not be used. The reagent should be protected from dust, dirt and bacteria

once opened.

●Soft cloth or gauze can be used for cleaning work. A little diluted detergent and alcohol can be

used if necessary. Pine oil and benzene can not be used for outside cleaning, it may cause color

and shape change.

●Outdoor temperature in winter is quite low. The analyzer should be placed at room temperature

for at least 24 hours before power on.

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Biohazard Marking:

●Please dispose the reagent, waste solution, waste sample and consumable according to the

local regulation.

●Sample, Control, Calibrator and waste solution have potential biochemical infectivity that may

hurt eyes, skin and mucosa. Operator should refer to the safety regulation for lab operation.

Protective measure should be taken (Such as lab protective clothes and gloves).

●Please dispose the waste solution and instrument consumable according to the regulation of

medical waste, infective waste and industrial waste. Blood in the waste may have been

contaminated by pathogens.

●Avoid reagent contact with eyes and skin, in case of any contact, rinse immediately with plenty

of water and seek medical advice if needed.

●Sampling probe is sharp-pointed which may with some material have potential bio-infectivity,

such as blood sample, Control and Calibrator. Contact with sampling probe should be avoided.

In sampling, there should be a certain distance between probe tip and the wall of the container to

avoid blood splash. Or the accuracy of aspiration volume may be affected.

●Avoid direct contact with the patient's blood.

●Disposable supplies can not be reused.

Content

III


Chapter 1 Brief Introduction...................................................................................................................1

1.1 Summary..................................................................................................................................... 1

1.2 Specification................................................................................................................................ 1

1.3 Working Principle......................................................................................................................... 3

1.3.1 Sample Aspiration.................................................................................................................3

1.3.2 Sample Dilution.....................................................................................................................4

1.3.3 WBC Testing......................................................................................................................... 7

1.3.4 WBC Parameter.................................................................................................................... 9

1.3.5 Hemoglobin Concentration Testing— Colorimetry..............................................................10

1.3.6 RBC / PLT Testing..............................................................................................................11

1.3.7 Rinsing................................................................................................................................ 13

1.4 Instrument Structure.................................................................................................................. 14

1.4.1 Front Picture....................................................................................................................... 14

1.4.2 Rear Picture........................................................................................................................ 14

1.4.3 Right Picture....................................................................................................................... 15

1.5 External Devices........................................................................................................................ 15

1.6 Symbol...................................................................................................................................... 15

Chapter 2 Installation.......................................................................................................................... 17

2.1 Installation Requirement............................................................................................................17

2.1.1 Space Requirement............................................................................................................17

2.1.2 Power Requirement............................................................................................................17

2.1.3 Environmental Requirement...............................................................................................17

2.2 Unpacking................................................................................................................................. 18

2.2.1 Unpacking Step..................................................................................................................18

2.2.2 Remove Method................................................................................................................. 18

2.3 Installation Steps....................................................................................................................... 18

2.3.1 Connecting.......................................................................................................................... 19

2.3.2 Software Installation...........................................................................................................20

2.4 Software Uninstallation..............................................................................................................26

2.5 Software Login........................................................................................................................... 26

2.5.1 Login Software....................................................................................................................27

2.5.2 Counting Interface..............................................................................................................28

2.5.3 Log Off................................................................................................................................ 30

2.5.4 Log Out............................................................................................................................... 30

Chapter 3 Instrument Setting...............................................................................................................32

3.1 Sample Information................................................................................................................... 32

3.2 Sample Registration..................................................................................................................33

3.2.1 Edit Patient Information......................................................................................................33

3.2.2 Copy Patient Information..............................................................................................37

3.2.3 Modify Patient Information............................................................................................38

3.2.4 Delete Patient Information............................................................................................38

3.2.5 Mask............................................................................................................................. 39

3.2.6 Query............................................................................................................................ 39

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3.3 Setting....................................................................................................................................... 39

3.3.1 Normal User........................................................................................................................ 39

3.3.2 Administrator User..............................................................................................................45

Chapter 4 Conventional Operation......................................................................................................59

4.1 Preparation before Operation....................................................................................................59

4.2 Daily QC.................................................................................................................................... 60

4.3 Sample Preparation................................................................................................................... 60

4.3.1 Whole Blood Sample Preparation:......................................................................................60

4.3.2 Preparation Method of Pre-dilution Sample (Peripheral Blood)..........................................60

4.4 Sample Testing of Whole Blood Mode......................................................................................63

4.4.1 Changing Test Mode and Sample No.................................................................................63

4.4.2 Sample Information Editing.................................................................................................64

4.4.3 Sample Testing Steps.........................................................................................................65

4.4.4 Picture Check..................................................................................................................... 66

4.4.5 Research Parameter Check................................................................................................67

4.5 Pre-dilution Sample Testing......................................................................................................68

4.5.1 Parameter Alarm................................................................................................................. 69

4.5.2 Differential or Abnormal Form Alarm..................................................................................69

4.6 Sleeping.................................................................................................................................... 71

4.7 Rinse and Clog Removal...........................................................................................................71

4.8 Shutdown.................................................................................................................................. 71

4.8.1 Shutdown Mainframe..........................................................................................................71

4.8.2 Exit Software....................................................................................................................... 72

Chapter 5 Record Query....................................................................................................................74

5.1 Record Selection....................................................................................................................... 75

5.2 Print........................................................................................................................................... 75

5.3 Query......................................................................................................................................... 77

5.3.1 Query Accroding to Sample No...........................................................................................78

5.3.2 Query According to ID Number...........................................................................................78

5.3.3 Query According to Test Mode and Date............................................................................78

5.3.4 Query According to Case No..............................................................................................79

5.3.5 Query According to Name and Sex.....................................................................................79

5.3.6 Query According to Department and Deliver Doctor...........................................................79

5.3.7 Query According to Auditor.................................................................................................79

5.3.8 Query According to Checker...............................................................................................79

5.4 CV Calculation........................................................................................................................... 79

5.5 Bulk Audit.................................................................................................................................. 80

5.6 Communication.......................................................................................................................... 81

5.7 Delete........................................................................................................................................ 81

5.8 Export........................................................................................................................................ 82

5.9 Chart Query............................................................................................................................... 83

Chapter 6 Quality Control....................................................................................................................84

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6.1 L-J QC....................................................................................................................................... 84

6.1.1 Quality Control Setting........................................................................................................85

6.1.2 QC Counting....................................................................................................................... 88

6.1.3 QC Result Review..............................................................................................................89

6.1.4 QC List................................................................................................................................ 92

6.2 QC......................................................................................................................................... 946.3 X-B QC...................................................................................................................................... 94

6.3.1 QC Setting.......................................................................................................................... 94

6.3.2 QC Counting....................................................................................................................... 96

6.3.3 QC Graph Review...............................................................................................................96

6.3.4 QC List Review...................................................................................................................97

Chapter 7 Calibration........................................................................................................................ 100

7.1 Calibration Frequency.............................................................................................................100

7.2 Calibration Method..................................................................................................................100

7.2.1 Preparation before Calibration..........................................................................................100

7.3 Calibration with Calibrator.......................................................................................................100

7.4 Fresh Blood Calibration...........................................................................................................103

7.4.1 Fresh Blood Preparation...................................................................................................103

7.4.2 Fresh Blood Calibration....................................................................................................103

7.5 Manual Calibration................................................................................................................... 106

7.6 Calibration Log........................................................................................................................ 107

Chapter 8 Service.............................................................................................................................. 108

8.1 Maintenance Guide................................................................................................................. 108

8.1.1 Regular Maintenance........................................................................................................108

8.1.2 Maintenance in Need........................................................................................................108

8.2 System Status......................................................................................................................... 109

8.2.1 System Version................................................................................................................. 109

8.2.2 Basic Status...................................................................................................................... 111

8.3 Mechanical Detect...................................................................................................................111

8.3.1 Motor Detect.....................................................................................................................112

8.3.2 Valve Detection................................................................................................................. 112

8.3.3 Pump Detection................................................................................................................112

8.4 System Maintenance...............................................................................................................113

8.4.1 Replacement / Priming......................................................................................................113

8.4.2 Rinsing.............................................................................................................................. 116

8.4.3 Maintenance.....................................................................................................................119

8.4.4 Reagent Registration........................................................................................................125

8.5 Replacement of Wearing Components....................................................................................126

8.5.1 Replace Syringe Pump.....................................................................................................126

8.6 System Log............................................................................................................................. 127

Chapter 9 Instrument Transportation and Storage............................................................................129

9.1 Transportation Requirement....................................................................................................129

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9.2 Storage Requirement..............................................................................................................129

Chapter 10 Failure Handling..............................................................................................................130

10.1 Overview............................................................................................................................... 130

10.2 Failure Information and Solution............................................................................................131

Appendix A........................................................................................................................................ 135

Appendix B........................................................................................................................................ 146

Appendix C........................................................................................................................................ 154

Appendix D........................................................................................................................................ 155

Statement.......................................................................................................................................... 157

VII


Chapter 1 Brief Introduction

1.1 Overview

BF-6500 Automatic Hematology Analyzer is used in medical laboratories to

quantitative analyze blood cell, carrying out 5-differential to white blood cell(WBC) counting

result, and offer scattergram of white blood cell 4-diff, histogram of red blood cell(RBC), white

blood cell(WBC) and platelet(PLT), histogram information of WBC 4-diff. It is a highly integrated

instrument with high-capability. It characterize in accurate test result, easy operation, low

consumable. The instrument can test quantitative analysis result of 24 blood parameters and 10

research parameters. Instrument is connected with computer to conduct operations.

The instrument is an in vitro diagnostic medical instrument used by professionals for screening.

When making clinical judgment according to the analysis result, the doctor should taking into

account the clinical test result or other test result.

1.2 SpecificationSample Volume: Whole Blood： CBC+DIFF Mode：20μL CBC Mode：10μL

Peripheral Blood： CBC+DIFF Mode：80μL（diluted）

CBC Mode：40μL（diluted）

Aperture Diameter: WBC Aperature：diameter 80μm, depth 80μm

RBC, PLT Aperature：diameter 70μm, depth 65μm

Laser Tube Wavelength: 540nm

Throughput: 60 T/H

Dilution Ratio: Whole Blood: WBC/HGB 1:583 RBC/PLT 1:30000,

WBC(differential) 1：200

Prediluted: WBC/ HGB 1:5830 RBC/PLT 1:300000,

WBC(differential ) 1：2000

Lyse Volume: SLS：0.5mL FDT：0.2mL FDO：1.0mL

Test Item(including research parameters)：

White Blood Cell WBC

Neutrophil Neu#

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Lymphocyte Lym #

Intermediate Cell Mon#

Eosinophil Eos#

Basophil Bas#

Blasts# Blasts#(research param)

Aty/Abn Ly# Aty/Abn Ly#( research param)

Imm Gran# Imm Gran#( research param)

Shift to Left LEFT#( research param)

Nucleated RBC NRBC#( research param)

Neutrophil Percentage Neu％

Lymphocyte Percentage Lym％

Intermediate Cell Percentage Mon％

Eosinophil Percentage Eos%

Basophil Percentage Bas%

Blasts Percentage Blasts% (research param)

Aty/Abn Ly Percentage Aty/Abn Ly% (research param)

Imm Gran Percentage Imm Gran% (research param)

Shift to Left LEFT%( research param)

Nucleated RBC NRBC%( research param)

Red Blood Cell RBC

Hemoglobin HGB

Mean Red Blood Cell Volume MCV

Mean Red Blood Cell Hemoglobin Content MCH

Mean Red Blood Cell Hemoglobin Concentration MCHC

Red Blood Cell Distribution Width Coefficient of Variation RDW-CV

Red Blood Cell Distribution Width Deviation Limitation RDW-SD

Hematocrit HCT

Platelet Number PLT

Mean Platelet Volume MPV

Platelet Distribution Width PDW

Plateletcrit PCT

Larger Platelet Cell Ratio P-LCR

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Diff Scattergram

RBC Histogram

PLT Histogram

WBC Histogram

WBC Diff Histogram

Storage: 30000 test results;

L-J/ QC: 12 documents, 400 records/ document;

X-B:1 document, 400 records

Working Environment: Temperature:15 ~30 Humidity : 30℃ ℃ ％~75％

Atmosphere Pressure: 75kPa~106kPa

Output: RJ45 port

Barcode Input: external barcode reader (equipped)

Power Supply: ~220V 50Hz

Fuse: 250V 4A

Power: Mainframe: 175VA

Weight: Mainframe: 46Kg

Dimension: Mainframe：490mm(L)×540mm(W)×550mm(H)

Electromagnetic Compatibility: The equipment complies with EN61326： 1997+A1 1998+A2

2001+A3 2003 of EMC test standard, meeting A level requirements, should not be installed near

devices tend to be interfered.

1.3 Working Principle

This instrument adopts electric impedance to test RBC, WBC/ Basophil, PLT number and

volume distribution. Test the hemoglobin concentration by using colorimetry. Adopting

semiconductor laser flow cytometry to obtain WBC 4-differential counting result. The result of

other parameters are calculated upon the above results.

1.3.1 Sample Aspiration

The instrument offers two sampling type: whole blood and pre-dilution mode.

In whole blood mode, the instrument aspirates 20μL（ CBC+DIFF mode） or 10μL（ CBC

mode）whole blood sample.

In pre-dilution mode, the operator should mix 20ul peripheral blood with 180ul diluent to form a

sample with dilution ratio of 1:10, and then send it to the analyzer for aspiration. The analyzer

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will aspirate 80 μL（CBC+DIFF mode）or 40μL（CBC mode）diluted sample.

1.3.2 Sample Dilution

The sample is divided into 2 parts after sample aspiration. And the sample will be dispensed into

WBC differential detector, WBC counting cell and RBC counting cell in order according to the

test requirement. Through the effects of different reagents while dilution process, forming

samples which are used for WBC differential testing, WBC/ hemoglobin testing and RBC/PLT

testing.

For different sample, the instrument offers two different working modes - whole blood mode and

pre-dilution (Peripheral Blood) mode.

1.3.2.1 Whole Blood Mode

a)RBC/PLT Dilution Process

b) WBC/Hemoglobin Dilution Process

Figure 1-3-1 RBC/PLT Dilution Process

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c)WBC Differential Dilution Process

1.3.2.2 Pre-dilution Mode

a)RBC/PLT Dilution Process

Figure 1-3-2 WBC/Hemoglobin Dilution Process

Figure 1-3-3 WBC Differential Dilution Process

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b) WBC/Hemoglobin Dilution Process

c) WBC Differential Dilution Process

Figure 1-3-4 RBC/PLT Dilution Process

Figure 1-3-5 WBC/Hemoglobin Dilution Process

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1.3.3 WBC Testing

1.3.3.1 Laser Flow Cytometry

At the effect of a certain amount of reagent, the blood sample is pipetted into flow cell which is

full of diluent. Under the package of sheath which is formed by diluent, the single cell flow goes

through the center of flow cell. As shown in Figure 1-3-7:

Figure 1-3-6 WBC Differential Dilution Process

Figure 1-3-7 Flow Cell

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Blood cells go through the laser area after twice acceleration. Under the effect of laser beam, the

scattered light is related to cell size, refractive index of cell membrane and cell internal structure.

Low-angle forward scattered light reflects the size of cell. High-angle forward scattered light

reflects the internal fine structure and particulate matter. Photodiode receive the scattered light

signals and translate them into electrical pulses, according to the electrical pulses, two-

dimension map(scattergram) of cell size and cell internal information can be obtained. The

abscissa reflects the cell's internal structure. The vertical axis reflects the cell size, as shown in

Figure 1-3-8:

Figure 1-3-8 4-diff Scattergram Drawing

The lymphocytes, monocytes, eosinophils and eutrophils percentage can be obtained from the

DIFF channel scattergram.

1.3.3.2 WBC Number/Basophil ---- Impedance Method

WBC number and basophils are counted through impedance method. The aspirated sample is

dispensed into test unit after diluted by quantitative conducting solution. The testing unit has a

test aperture. A pair of positive and negative electrodes exist beside the aperture for connecting

the constant current power supply. As the cells have the characteristic of a poor conductor, when

the cell goes through the aperture under constant negative pressure, the DC resistance between

the electrodes will change, resulting in the formation of a pulse signal which is proportional to the

cell size. A series of electrical pulse is produced when the cell continuously go through the

aperture. The number of pulses is equivalent to the cell number through the aperture. The pulse

amplitude is proportional to the cell size.

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Figure 1-3-9 Counting Principle Diagram

Compare the amplified electric pulse with voltage range corresponding to normal WBC size

range. Calculate the electrical pulse number. All electrical pulse is classified according to

different channel voltage range. Electrical pulse number which fell in WBC channel is WBC

number. Cell number in each channel which is divided according to pulse voltage range

determines the cell size distribution.

1.3.4 WBC Parameter

Through analyzing Diff channel scattergram, Lym area, Neu area, Mon area and Eos area, the

percentage of lymphocytes (Lym%), the percentage of neutrophils (Neu%), the percentage of

mononuclear cells (Mon%), as well as the percentage of eosinophils (Eos%) can be obtained.

Calculate by using the WBC number, lymphocytes (Lym #), neutrophils (Neu #), mononuclear

cells (Mon #) as well as eosinophils (Eos #) can be obtained. Cell unit is 109/L.

●WBC

WBC number can be obtained through testing the corresponding pulse number.

●Basophil

Basophil number can be obtained through testing the corresponding pulse number.

●Basophil Percentage

●Lymphocyte Percentage

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●Neutrophil Percentage

●Monocyte Percentage

●Eosinophil Percentage

●Lymphocytes

Lym#= WBC×Lym%

●Neutrophil

Neu#= WBC×Neu%

●Monocyte

Mon#= WBC×Mon%

●Eosinophil

Eos#= WBC×Eos%

1.3.5 Hemoglobin Concentration Testing— Colorimetry

SLS-hemoglobin method combined with the oxy hemoglobin method and cyano-hemoglobin

method. It characterize in high hemoglobin conversion speed and no toxic substance, applicable

to automatic testing instrument.

SLS-hemoglobin method is needed in hemoglobin concentration testing. In colorimetry pool, the

diluted sample is mixed with lyse, RBC dissolve, releasing hemoglobin. Hemoglobin combined

with lyse to form hemoglobin complex. At one end of the colorimetry pool, the hemoglobin

complex is irradiated by monochromatic light with a wavelength of 540nm (LED light tube).

Phototube is used at the other end to receive transmission light, and convert the light signal into

voltage signal. By comparing with the voltage produced by background transmission light

intensity before sample adding(only diluent exists), the hemoglobin concentration can be

obtained(HGB), unit is g／L. This testing and calculation process will be finished by the analyzer

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automatically, and the result will be displayed in the counting interface.

1.3.6 RBC / PLT Testing 1.3.6.1 Impedance Method

This instrument adopts the electric impedance method to count red blood cell / platelet. RBC /

platelet sample flow into RBC test unit after twice dilution. The testing unit has a test aperture. A

pair of positive and negative electrodes exist beside the aperture. As the cells have the

characteristic of a poor conductor, when the cell go through the aperture under constant

negative pressure, the DC resistance between the electrodes will change, resulting in the

formation of a pulse signal which is proportional to the cell size. A series of electrical pulse is

produced when the cell continuously go through the aperture. The number of pulses is

equivalent to the cell number through the aperture. The pulse amplitude is proportional to the cell

size.

Compare the amplified electric pulse with channel voltage value corresponding to normal

RBC/PLT size range. Calculate the electrical pulse number. All electrical pulse is classified

according to different channel voltage value. Electrical pulse number which fell in RBC/PLT

channel is RBC/PLT number. Cell number in each channel which is divided according to pulse

voltage range determines the cell size distribution. The two-dimensional map with cell size as

abscissa and cell number as vertical axis is the histogram reflects the distribution of cell.

1.3.6.2 Size Testing Method

The precise control upon sample volume that goes though the aperture during testing is the

premise of getting accurate result. Quantitative injection pump ensures the sample volume that

goes through the testing aperture is tested. Sample volume is determined by the running steps

of motor.

1.3.6.3 RBC Parameter

● RBC Number

RBC number is obtained through testing corresponding electrical pulse.

Unit: 1012／L

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RBC=n×l012／L

●Mean RBC Size

Calculate mean RBC size according to RBC distribution histogram. Unit: fL

●RBC hematocrit, mean RBC hemoglobin content, mean RBC hemoglobin concentration

Calculate RBC HCT according to the following formula, unit ％; mean RBC hemoglobin content

(MCH), unit Pg; mean RBC hemoglobin concentration (MCHC), unit g/L

HCT

Mean hemoglobin content

Mean hemoglobin concentration

RBC Unit: 1012／L, MCV Unit: fL, HGB Unit: g／L

●RBC Distribution Width Variation Coefficient

RDW-CV is obtained through RBC distribution histogram. The volume distribution variation

coefficient is in the form of percentage.

●RBC Distribution Width Standard Deviation

RDW-SD is histogram width relative to RBC distribution histogram peak (20%), unit fl, as shown

in figure 1-3-10.

● RBC Distribution Histogram

The RBC volume distribution histogram is offered when the result is obtained. The graph that

can indicate the distribution of cell population is RBC distribution histogram. Histogram abscissa

is RBC size (unit: fl), vertical axis is RBC relative number (unit: 1012/L). After each counting, RBC

Figure 1-3-10

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distribution histogram can be obtained in analysis result area of counting interface. RBC

distribution histogram can also be obtained through entering search interface.

1.3.6.4 PLT Parameter

●PLT Number（PLT）

PLT number is obtained through testing corresponding electrical pulse number, unit 109／L

PLT=n×l09／L

●Mean PLT Volume (MPV)

Calculate mean PLT volume according to PLT distribution histogram. Unit: fL

●PLT Distribution Width (PDW)

PDW is obtained through PLT distribution histogram, which is geometric deviation limit of PLT

volume (10GSD)

●PCT

Calculate PCT according to the following formula, unit ％; PLT unit 109／L unit ; MPV unit fl

PCT=

●Big PLT Ratio（P-LCR）

Big PLT Ratio is obtained through PLT histogram.

●PLT Distribution Histogram.

The PLT volume distribution histogram is offered when the result is obtained. The graph that can

indicate the distribution of cell population is PLT distribution histogram. Histogram abscissa is

PLT volume (unit: fl), vertical axis is PLT relative number (unit: 109/L). After each counting, PLT

distribution histogram can be obtained in analysis result area of counting interface. PLT

distribution histogram can also be obtained through entering search interface.

1.3.7 Rinsing

The instrument rinse itself automatically in each counting process, to ensure no residual sample

exists.

● Internal and external wall of sampling probe should be rinsed with diluent;

● Counting pool, quantitative pump should be rinsed with diluent;

● Flow cell should be rinsed with diluent.

PLT×MPV10000

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1.4 Instrument Structure

Instrument is composed of mechanical motion, pipeline, optical, electronic control, software, etc.

The appearance is as follows:

1.4.1 Front Picture

①Front Door Indicator② (yellow-failure status indicator, green-running status indicator, red-

power indicator from left to right) Sampling Probe ③ ④Sample Aspiration Key

1.4.2 Rear Picture

Figure 1-4-1 Front Picture

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①Right Door ②⑥ Fan ③Upper Cover ④Back Cover ⑤Left Door ⑦BF-SLS-I Lyse Inlet

⑧BF-FDO Lyse Inlet ⑨BF-FDT Lyse Inlet ⑩BF-PK Diluent Inlet Waste Solution Inlet

Figure 1-4-2 Rear Picture

1.4.3 Right Picture

①Net Port(LAN) ②Sensor Port ③Power Supply ④ Power Switch

Figure 1-4-3

1.5 External Devices

Printer：Connect with computer. The report can be printed through computer.

Barcode Scanner：Connect with host computer to input barcode information.

Note：The Printer is optional.

1.6 Symbol

The following symbols include the symbols on the analyzer, reagent, Control and Calibrator.

Symbol Meaning

The prompts to pay attention, otherwise, may result in personal

injury.

To perform as the instruction under the symbol, emphasize the

important information and special contents.

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To perform as the instruction under the mark, or it may cause

biological infection

Laser Warning

AC symbol

Only in vitro diagnostic use

Storage temperature

Lot NO.

Validity

Serial number

Measurement control

Date of manufacture

Grounding

Manufacturer

Instrument conform to the in vitro diagnosis device directive of EU

Access to supplied file

16


Chapter 2 Installation

To ensure the normal working of the instrument after installation，the initial installation and set-

up of BF-6500 Automatic Hematology Analyzer should be carried out by authorized personnel of

Dirui.

Note:

Dedicated computer software should be used for controlling. It is recommended that the

software and database is not installed in system disk.

2.1 Installation Requirement

The space, power, environment should meet the requirement prior to instrument installation. The

instrument should be placed on level operating table.

2.1.1 Space Requirement

Ensure enough space for instrument maintenance.

● The space between the wall and the right & left side of the instrument ≥50cm

● The space between the wall and the back side of the instrument≥50cm

● The space between the front of the analyzer and other equipment ≥ 100cm;

● Ensure enough space under and above the instrument for diluent, reagent and waste solution

collecting devices.

2.1.2 Power Requirement

● Power : ~220V 50Hz

● Analyzer Rated Power :175VA

● Fuse : 250V 4A；

● Large load equipment like air conditioner, refrigerator, oven etc. should not be inserted in the

same outlet. A good grounding is must.

2.1.3 Environmental Requirement

17


● Working Temperature：15 -30℃ ℃；

● Relative Humidity：≤75％;

● Atmospheric Pressure：75kPa-106kPa；

● The instrument should be protected from dust, mechanical vibration, significant noise and

power interference.

● It is recommended that the electromagnetic environment assessment of the laboratory should

be conducted prior to test.

● Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as

these may interfere with the proper working.

● It should be placed far from the constant ON-OFF electrical devices like brush-type motor,

fluorescent lamp.

● It should be placed far from heat and wind source, sunlight, brush-type motor, flickering

fluorescent light and electrical contact equipment.

● A well-ventilated place is a must.

Note:

The result will be unreliable if the room temperature or power can not meet the requirement. Or

cause instrument damage and endanger personal safety.

2.2 Unpacking

2.2.1 Unpacking Step

● Check the packaging of the instrument. Contact Dirui or local distributor for any physical

damage.

● Place the package in the direction of the arrow upward.

● Open the accessory box, mainframe box, check the items according to the packing list.

Contact Dirui or local distributor for any shortage.

2.2.2 Remove Method

● Long-distance remove, after"clean pipe "and "empty pipe "(refer to 8.4.3.1)

● Cart can be used for short distance removal.

●The sampling probe should be protected carefully in removing and transportation.

● Keep the instrument upright in removing and transportation.

● Vibration should be avoided in removing and transportation. It should be used after checking

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and debugging.

2.3 Installation Steps

The instrument should not be disassembled except normal maintenance.

2.3.1 Connecting

Figure 2-3-1 Analyzer and Reagent Connection

(a) Lyse, Diluent, Waste Solution Connecting

Put the BF-FDT lyse、BF-FDO lyse、SLS-I lyse bottle at the back of the instrument. Connect

according to figure 2-3-1.

Diluent container should be put under the working table. Connect according to figure 2-3-1.

(b) Liquid Level Sensor Connecting

Connect one end to in figure 1-4-2. Put the other end into the waste barrel, reagent bottle and

diluents according to the mark on the lead.

Note：Waste liquid should be disposed according to relevant local medical waste treatment

regulations.

(c)Computer Connecting

Connect “Net Port” of computer host with “Net Port” of right side analyzer(figure 1-4-2 )

(d) Power Wire Connecting

Connect one end of supplied power line with the attaching plug on the back side of the

analyzer(③ of figure 1-4-2). And connect the power line of host, display and printer.

19


Note: The socket connected with the power wire should be well-grounded.

(e) Barcode Reader Connecting

Insert one end of the bar code reader into the “USB” of the computer host.

Note: The light beam of the barcode scanner may hurt eyes, therefore, staring should be

avoided.

(f)Printer Connecting

Connect the printer and the computer host through data wire.

（1）Whether the printer driver is installed.

（2）Check the printing paper specification.

Note: Tie wires will be used for fixing sampling probe before delivery. Wire 1 and 2 should be

removed before power on, otherwise, probe may be damaged, as figure shows:

Figure 2-3-2

2.3.2 Software Installation

The software has been installed by DIRUI professionals before delivery. User should not

uninstall it except abnormity occurs. In case of a must-uninstall, please follow the following

steps:

To start setup.exe after putting Hematology Analyzer Installation software CD in CD driver of

computer, “NET Framework3.5” install assembly will pop up, as figure 2-3-3 shows:

Wire1

Wire 2

20


Figure 2-3-3

Select “Accept” in above figure, SQL Server2005 Express Edition SP2（x86）will pop up, as

figure 2-3-4 shows:

Figure 2-3-4

Select “Accept” in above figure, as figure 2-3-5 shows:

21


Figure 2-3-5

Click “Install” in above figure, “NET Framework3.5” interface will pop up, as figure 2-3-6, 2-3-7

shows:

Figure 2-3-6

Figure 2-3-7

When the above two installation have been finished, “SQL Server 2005 Express Edition

SP2(x86)” will pop up, as figure 2-3-8 shows:

22


Figure 2-3-8

When the above installation has been finished, if other software is running, reboot the interface

before the continuous running of popped installation program. As figure 2-3-9 shows:

Figure 2-3-9

Select “Install” in above figure, the installation interface will pop up after rebooting, as figure 2-3-

10, 2-3-11 shows:

Figure 2-3-10

23


Figure 2-3-11

Click “Next” in above figure, select the installation path, the default path is C:\Program Files\

BF6500\. As figure 2-3-12 shows:

Figure 2-3-12

Click “Next” in above figure, the confirm interface will pop up, as figure 2-3-13 shows:

24


Figure 2-3-13

Click “Next” in above figure, “Installing BF6500 ” interface will pop up, as figure 2-3-14 shows.

Figure 2-3-14

Click “Next” after installation has been finished, figure 2-3-15 will pop up:

25


Figure 2-3-15

Click “Close” in above figure to finish the installation of the software. The shortcut of the program

will be displayed on the table after installation.

2.4 Software Uninstallation

If the Automatic Hematology Analyzer application software need to be deleted from the current

computer, click “Start” window, find “BF-6500” in “Program”, click “Uninstall BF-6500”, the

confirm window will pop up, as figure 2-4-1 shows:

Figure 2-4-1

Click “OK” to finish the uninstallation.

2.5 Software Login

Note: Turn on the power switch of the analyzer, login the application software.

26


2.5.1 Login Software

Double click the application software , or click “Start”, find the software in “Program”

window, enter into “System Login” window, as figure 2-5-1, 2-5-2 shows:

Figure 2-5-1

Figure 2-5-2

Input username, password, the initial user name is Admin(can not be modified), the initial

password is 1). If the input username or password is wrong, the screen will display login error, as

figure 2-5-3 shows:

27


Figure 2-5-3

The program will exit automatically if the username or password error occurs for continuous 3

times.

Input username, password in figure 2-5-2, click “Login”. Liquid pipeline, temperature and

pressure self-test will be conducted by the instrument(the screen will display “System self-

testing…..”). Main window will be displayed after self-testing. As figure 2-5-4 shows:

Figure 2-5-4

2.5.2 Counting Interface

2.5.2.1 Main MenuTest：For sample information input, sample test mode selection, test records query.

QC： L-J/Xbar and X-B QC.

Calibration：Conducting calibration upon the analyzer.

Setting：Set the analyzer parameters.

Service：Test the status, maintain and detect the analyzer.

Log：Keep the operation records.

2.5.2.2 Status Indication AreaFrom left to right: network connection status, LIS system connection status, printing status:

Main Menu

Shotcut Status

28


（a） Network Connection Status：

：Indicates the network is connected, operations are accessable.

：Indicates the network is disconnected.

（b） LIS System Connection Status：

：Indicates LIS is connected，communication operation is accessable.

：Indicates LIS is disconnected.

：Indicates LIS is transmitting.

（c） Printer Status：

：Indicates the printer is connected, printing is accessable.

：Printer is disconnected.

：Printer is working.

2.5.2.3 Public Information AreaBottom of the counting interface is the public information area, as figure 2-5-5 shows:

Sample No.

Failure Info.

Running Status

X-B StatusUsername

Sample Info.

System Time

Info. Area

29


Figure 2-5-5

（a）Failure Information Area:

The corresponding failure information will be displayed in this area when failure occurs. Click this

area, the failure dialog box will pop up, as figure 2-5-6 shows:

Figure 2-5-6

Click the corresponding information, the detailed solution will be displayed in “Detail Information”

（b）X-B QC Switch Status：

Use icon to indicate the switch status of X-B QC. With X-B is ON, without X-B is OFF.

(c) Sample Status: Display the analysis mode and test mode.

Analysis Mode: There are two modes. Whole blood mode and pre-diluted(peripheral blood).

Test Mode: There are two mdoes.【CBC】and【CBC+DIFF】.

（d）Test Status: Indicates the test status.

2.5.3 Log Off

Click in figure 2-5-4, as figure 2-5-2 shows:

2.5.4 Log Out


30


Figure 2-5-7

Click OK in above figure to exit. Click Cancel to return to interface.

Note:

Log off is recommended when the user is at rest. For avoiding non-user damage software or

modify the data. Periodical database backup is recommended to avoid data lose caused by

unforeseen circumstances.

Input the initial user name and password in the first login. Set the user name, permission and

password in "User Setting" after login for next login.

31


Chapter 3 Instrument Setting

The system parameter of the instrument has been set before delivery. The interface of the first

power on is system default. In order to meet the different needs of practical application, two

permissions are provided(user permission and administrator permission), the user can reset

some parameters.

3.1 Sample Information


Figure 3-1-1

Analysis Mode: There are two modes. Whole Blood mode and predilute(peripheral blood) mode.

Test Mode: There are two modes.【CBC】conduct counting without diff upon WBC, counting

result includes histogram and its parameter of WBC, RBC and PLT.【CBC+DIFF】 conduct

counting and differential upon WBC, includes 24 parameters and scattergram, histogram.

Sample No.: The sample No. input in this box is the next tested sample.

Note:

Sample No. with “-” is accessible. “.” is NOT accessible(“Sample No. Error” will be prompted if

there is “.”).

32


Reference Range: Click the drop down list of “Reference”, general, man, woman, child, infant

and user-defined can be seleted.

3.2 Sample Registration

Click of main interface shortcut in figure 2-5-4, “Sample/Patient Information” will pop

up, as figure 3-2-1 shows:

Figure 3-2-1

3.2.1 Edit Patient Information

Click “Setting”in figure 3-2-1to set the input items of patient information, displays as figure 3-2-2:

33


Figure 3-2-2

Default Value：This value is default when editing other sample information.

Remember： If , the last edited sample information will be remembered when editting

other information.

Ignore：If , this item will be skipped during patient information input.

Click “OK” when “Default Value”, “Remember” and “Ignore” have been set. The mouse will move

to the input box of sample No. in figure 3-2-1 to edit patient information.

3.2.1.1 Sample Information

（a）Sample No.：Set the next sample No. manually.

（b）Barcode No.：Can be input manually or by scanning.

（c）Reference：Double click the input box behind “Reference” in figure 3-2-1,the following box

will pop up:

34


Figure 3-2-3

Input the corresponding memoni in the input box of “System Code Selection”, or click the line of

corresponding item(“Setting” of main menu→ “Information” to set the commonly used ID).Click

“OK”.The reference range of test items includes general, man, woman, child, newborn and 5

user define.

（d）Sampling Time, deliver time: Select “Current Time” or “ Empty” in the drop-down list of

“Sampling Time”, “Deliver Time” in figure 3-2-1. If “Current Time” is selected, click the

corresponding time, manual input is also available.

3.2.1.2 Patient Information

(a) Case No.: Input the case No. in figure 3-2-1.

(b) Name：Input the patient name directly.

(c) Sex: Double click the input box behind “Reference” in figure 3-2-1, the following box will pop

up:

Figure 3-2-4

35




“OK”.

（d）Age：Input the patient age and double click the input box of age unit, the following box will

pop up.



“OK”.

Note: There should be no “.” in age.

(e) Department：Input the department name in department box, double click “Department” input

box, the following box will pop up:

Figure 3-2-6


Figure 3-2-5

36



“OK”.

（f）Bed No.：Click the input box of “Bed No.”in figure 3-2-1or input it directly.

（g）Deliver：Input it directly or double click the input box of “Deliver”, the following figure will

pop up:

Figure 3-2-7



“OK”.

（h）Remark：the remark information after test can be input(can be input directly).

Press enter to save the information when all the information have been finished.

3.2.2 Copy Patient Information

In batch patient information input, input one patient information first and then copy it, modify part

of the information at last.

In figure 3-2-1, select the number of the information need to be copied, the selected line will turn

into blue, click “Copy”, as figure 3-2-8 shows:

37


Figure 3-2-8

Input the copy number in the input box behind “Copy”, and click “OK”, the selected information

will be copied.

3.2.3 Modify Patient Information

The copied information need to be modified. In figure 3-2-1, select the number of the information

need to be modified, the selected line will turn into blue. The selected patient information will be

displayed on the left of the screen, which can be modified.

Press “Enter” for saving after modification(refer to 3.2.1 for operation).

3.2.4 Delete Patient Information

In figure 3-2-1, click the number of the information need to be deleted, click “Delete”, the drop-

down menu will pop up, select the item need to be deleted, as figure 3-2-9

shows, click “OK” to finish the deletion.

Figure 3-2-9

38


3.2.5 Mask

In figure 3-2-1, select the number of the information need to be masked, the selected line will

turn into blue( in front of the number will be selected). Click “Mask”, the “Mask Status” will be

“Masked”. Click “Cancel Mask” to switch it into “Unmasked”.

Note:

The masked sample number(this record) will not be tested during test.

3.2.6 Query

Click “Query” in figure 3-2-1, as figure 3-2-10 shows:

Figure 3-2-10

Sample information can be queried according to “Sample No.” “Case No.” and “Name”.

3.3 Setting

3.3.1 Normal UserClick ”Setting” in main menu, as shown in figure 3-3-1：

39


Figure 3-3-1

3.3.1.1 Date Format Setting

There are three date formats：

YYYY-MM-DD、MM-DD-YYYY、 DD-MM-YYYY， select one of them and press”Apply”, the

following information will be displayed：

Press “OK” to save the changed date format. Press “Exit” to exit the interface.

Note：

The changed date will be displayed in all positions with time(such as delivery time, sampling

time, etc.).

3.3.1.2 Language Setting

Click “Language Settings” in figure 3-3-1, as figure 3-3-3 shows:

Figure 3-3-2

40


Figure 3-3-3

Click the drop-down menu behind “Select Language”, select the language, click “Apply”, the tip

“Save Success” will pop up, click “OK” to finish the language setting. As figure 3-3-4 shows:

Figure 3-3-4

Chinese and English are for selection.

3.3.1.3 User Setting

Click “User Settings” in figure 3-3-3, as figure 3-3-5 shows:

41


Figure 3-3-5

Only the password can be modified when the user login as common user. Click “Modify

Password” in figure 3-3-5, as figure 3-3-6 shows:

Figure 3-3-6

Input the new password and old password(the two passwords must be same), click “OK” to finish

the modification.

Note:

User edition, addition and deletion can not be conducted when the user login as common user.

3.3.1.4 Reagent Validity Setting

Single click “Reagent Validity Setting” in figure 3-3-5, as figure 3-3-7 shows:

42


Figure 3-3-7

Click the drop down box of corresponding item, select the validity according to the reagent

instruction, press “Apply”, the tip “Save Success” will pop up, click “OK” to finish the setting. Click

“Exit” to exit the interface.

Note:

The validity should be set again in the first time analyzer using or after reagent, diluent

replacement. Expired reagent, diluent can not be used.

3.3.1.5 QC Setting

Click “QC Setting” in figure 3-3-7, as figure 3-3-8, 3-3-9 shows:

43


Figure 3-3-8

Figure 3-3-9

Control method, calculation method and range of L-J/X-bar QC can be selected in figure 3-3-8.

ON/OFF and sample No./group of X-B QC can be set in figure 3-3-9.

3.3.1.6 Print Setting

Click “Print Setting” in figure 3-3-9. Printer name, pageheader icon, title and format of sample

and QC can be set in figure 3-3-10.

44


Figure 3-3-10

（a）Printer：Select the printer in its drop-down list.

（b）Report Default Icon: Report pageheader icon can be set. Click “Select Picture”, the dialog

box of picture path will pop up. Select the picture(picture size is 34*34, format can be BMP and

JPG).

Click “Clear Picture” to clear the pageheader icon. The icon will not be displayed in report

preview.

（c）Sample：Headline, pagefooter and print report format can be input in this unit.

Headline： Delete the original headline and input new headline if headline need to be

changed.

Page Footer：The page footer is user-defined, e.g. “This report is only responsible for the

delivered sample.”

Print Report Format: Select the format in its drop-down list. Click “Preview” to preview the

format.

（d） QC：The headline and print report format can be input in this unit.

Headline：Delete the original headline and input new headline to change it.

Print Report Format：Select the print format in its drop-down menu, and click ”Preview” to

preview the format.

（e）Wintable：User can design report format.

Refer to “Appendix B” for its using.

3.3.2 Administrator User

Input administrator username and password when login(figure2-5-2), click “Setting”, as figure 3-

3-11 shows, the administrator can set the following items besides common user’s :

Note:

Admin is system default administrator username. Default password is 1. The password can be

modified, but can not be deleted.

45


Figure 3-3-11

3.3.2.1 User Settings

Click “User Setting” in figure 3-3-11, as figure 3-3-12 shows:

Figure 3-3-12

· Add User：

Click “Add” in figure 3-3-12, as figure 3-3-13 shows:

46


Figure 3-3-13

Input the username need to be added in the input box behind “Username”. Click to , which is in

front of “Audit Permission” if the user needs audit permission, and click “OK” to finish the user

adding.

Click “OK” after username input if this user does not need audit permission.

Note:

The initial password of the new user is “1”, which can be modified after login.

The name of new user can not be empty or same as other username.

·Delete User：

Click the line of common user in figure 3-3-12, the selected line will turn into blue, the interface is

like 3-3-14:

Figure 3-3-14

Click ”Delete” in above figure, the following prompt will pop up:

47


Figure 3-3-15

Click “Yes”, the selected user will be deleted.

·Edit User：

Click the line of common user in figure 3-3-14, click “Edit”, the interface is like 3-3-16:

Figure 3-3-16

The audit permission of common user can be edited again. Select the radio in front of “Audit

Permission” to give the permission to the user. Cancel it to cancel the permission.

· Modify Password：

The password of the administrator and common user can be modified by administrator.

Click the line needs to be modified in figure 3-3-14, click “Modify Password”, the interface is like

3-3-17:

Figure 3-3-17

Input old password, new password, press “OK” to finish the operation.

48


3.3.2.2 Net Setting

Click “Net Setting” in figure 3-3-14, and select “Local Setting” in the displaylink, as figure 3-3-18

shows:

（a）Local Setting:

Figure 3-3-18

The IP address and subnet mask, etc. of the computer will be displayed.

（b）Device Setting：

Select “Device Setting” in figure 3-3-18, as figure 3-3-19 shows:

Figure 3-3-19

49


The IP of hematology analyzer can not be modified by the user.

（c）LIS Setting：

Select “LIS Setting” in figure 3-3-19, as figure 3-3-20 shows:

Figure 3-3-20

IP and port of LIS computer can be set. ON/OFF status of auto-communication can be selected.

3.3.2.2 Unit Setting

Click“Unit Setting” in figure 3-3-20, as figure 3-3-21 shows:

Figure 3-3-21

50


Single click the input box behind items and select the units. Click “Apply” after input. Click “OK”

when “Save Success” is prompted. Click “Default Value” to restore the setting when the unit has

been modified accidentally.”Default value setting succeed” indicates successful setting.

The units are as follow:

Parameter Unit Value Form Remark

WBC

109/L ***.** Default Unit

103/uL ***.**

102/uL ****.*

/nL ***.**

LYM#、MON#、BAS#、EOS#、NEU 109/L ***.** Default Unit

LYM%、MON%、BAS%、EOS % **.* Default Unit

RBC

1012/L **.** Default Unit

106/uL **.**

104/ uL ****

/pL **.**

HGB

g/L *** Default Unit

g/dL **.*

mmol/L **.*

MCV、RDW-SDfL ***.* Default Unit

um3 ***.*

MCHpg **.* Default Unit

fmol ***

MCHC

g/L *** Default Unit

g/dL ***.*

mmol/L ***.*

RDW-CV % **.* Default Unit

HCT% **.*

L/L *.*** Default Unit

PLT

109/L **** Default Unit

103/uL ****

104/uL ***.*

/nL ****

MPVfL **.* Default Unit

um3 ***.*

PDW fL **.* Default Unit

PCT% .*** Default Unit

mL/L *.**

P-LCR % **.* Default Unit

Table 3-1

51


Note:

The result form changes as the unit changes.

3.3.2.3 Reference Value Setting

Reference range of general, man, woman, child, newborn and 5 user-defined are for selection,

which is default as “General”.

Single click “Reference Setting” in figure 3-3-21, as figure 3-3-22 shows:

Figure 3-3-22

Upper, lower Limit of Reference Input:

Click the inputbox of upper and lower limit to input the values.

Click “Apply” after input. Click “OK” after the prompting of “Saving succeed” to finish the saving.

The following box will pop up if the input lower limit is greater than the upper limit, or the input

reference is not within the set range.

Figure 3-3-23

Input again after checking if the above box is prompted.

52


Click “Default Value” to restore the setting when the reference has been modified accidentally.

“Default value setting succeed” indicates successful setting.

Figure 3-3-24

3.3.2.4 Log Setting

Click“Log Setting” in figure 3-3-22, as figure 3-3-25 shows:

Figure 3-3-25

The saving path of “Operation Log” and “Error Log” can be set.

Note: The old records will be covered if the records reach the maximum saving number. Records

can be saved for 1 year at most.

3.3.2.5 Information Setting

（a）Department Information Setting：

Click “Information” in figure 3-3-25, and select “Department Information” in the drop-down list of

“Information Type”, as figure 3-3-26 shows:

53


Figure 3-3-26

· Add Department Information：Input the department name in the input box behind name. Input

the commonly used memoni in the input box behind ID, click “Add”.

·Delete Department Information ： Select the items need to be deleted in the department

information list, click “Delete”.

（b）Doctor Information Setting:

Select the “Doctor Information” in the drop-down list of “Information Type”, as figure 3-3-27

shows:

Figure 3-3-27

54


· Add Doctor Information： Input the doctor name in the input box behind name. Input the

commonly used memoni in the input box behind ID, click “Add”.

· Delete Doctor Information：Select the items need to be deleted in the doctor information list,

click “Delete”.

（c）Reference Selection:

Select the “Reference” in the drop down list of “Information Type”, as figure 3-3-28 shows:

Figure 3-3-28

Select “General”, “Man”,”Woman”,”Child”,”Newborn”,”User Define 1”, ”User Define 1”,

”User Define 2”,”User Define 3”,”User Define 4” and ”User Define 5” in reference list. Only the

commonly used ID of reference can be modified here, but not the name or add other reference.

（d）Sex Selection：

Select “Sex” in the drop down list of “Information Type”, as figure 3-3-29 shows:

55


Figure 3-3-29

Select “Male” or “ Female” in the sex list.Only the commonly used sex ID can be changed here.

（e）Age Unit Selection：

Select the “Age” in the drop down list of “Information Type”, as figure 3-3-30 shows:

Figure 3-3-30

Select “Years Old”, “Month”, “Day” or “Hour” in the list of age unit. Only the commonly used age

unit ID can be changed here.

3.3.2.6 Backup Setting

56


Select “Backup Setting” in figure 3-3-30, as figure 3-3-31 shows:

Figure 3-3-31

（a） Backup：

Periodical database backup can prevent data lose.

Single click “Backup” to backup the document into the folder. The default saving path is

“backup”of software installation. The folder name is the current date+time+*.bak. Click “Apply”

for saving.

（b） Data Recovery：

The backup data can be used to recover the previous data if software can not be used for some

reason. Select the saving path of backup folder before recovery. And select the document

according to the backup date and time.

3.3.2.7 Abnormal Mark Setting

Click “Abnormal Marker Setting” in figure 3-3-31, select “WBC”, as figure 3-3-32 shows:

57


Figure 3-3-32

Select “RBC/PLT”, as figure 3-3-33 shows:

Figure 3-3-33

The prompt range of WBC, RBC/PLT abnormal alarm information can be set in this interface.

Click “Apply” for saving after input, click “Default Value” to recover, click “Exit” to cancel the

interface.

58


Chapter 4 Normal Operation

This chapter describes the whole process of daily operation from start to shut down. Focusing on

the operation process of whole blood sample and pre-dilution (Peripheral Blood) sample testing.

As shown in figure 4-1：

4.1 Preparation before Operation

Check the instrument before using according to the following requirement.

1. Check the waste barrel

To ensure daily empty before use.

2. Check pipeline

Check the pipeline connected with reagent, waste liquid, and also the grounding.

3. Check the power supply

Check the connection between power plug and power socket of the instrument, and the

computer.

4. Check the printer

Check the connection between the computer and printer.

Check the printing paper and its installation.

Figure 4-1

59


5. Check the barcode reader

Check the connection between the computer and the barcode reader.

4.2 Daily QC

Note:

QC analysis should be conducted everyday before sample analyzing to ensure reliable result.

Refer to chapter 6 for operation.

4.3 Sample Preparation

4.3.1 Whole Blood Sample Preparation:

1．Use clean EDTA-K2 (1.5—2.2mg／mL blood)anti freezing vacuum tube to collect venous

blood sample for more than 500ul.

2．Mix the venous blood with anticoagulant promptly.

Note：

Use clean EDTA-K2 anti freezing vacuum blood collecting tube, silicified glass/plastic tube

and 20uL silica glass capillary.

The sample that needs WBC differential or platelet counting should be stored at room

temperature. It should be used within 8 hour after collection.

If 5 part of PLT, MCV, or WBC is not needed, the sample can be stored at 2 - 8 in℃ ℃

refrigerator for 24 hours. The stored sample should be used after placing at room

temperature for at least 30 minutes.

After a period of time of still placing, the sample should be mixed again before use.

4.3.2 Preparation Method of Pre-dilution Sample (Peripheral Blood)

· Click in shotcut area, the screen display as figure 4-3-1, 4-3-2 shows:

60


Figure 4-3-1

Figure 4-3-2

·Take a clean tube or centrifuge tube, place it under the sample probe, as figure 4-3-3 shows:

Figure 4-3-3

Press aspiration key, the diluent will be dispensed into the tube, the screen displays as figure 4-

3-4 shows:

Figure 4-3-4

61


Ensure all the diluent(180uL)is added into the tube. Move the tube after the buzzer sound has

been heard.

· And put 20 uL peripheral blood into the tube follow the tube wall. Mix them.

· Click “Cancel” in figure 4-3-2, as figure 4-3-5 shows:

Figure 4-3-5

Cancel diluent adding to finish one preparation of diluted sample.

· If there are some sample need to be diluted after the first one, the interface will be as figure 4-

3-2, repeat the first process to finish other sample dilution. About 20 sample dilution can be

done continuously.

Note：

●The operator can also use pipette to aspirate 180uL diluent and dispense it into the tube follow

the tube wall. And add 20 uL peripheral blood into the tube follow the tube wall. Mix them.

● When “pre-dilute” is selected, “Attention! Dilute sample in ratio of 1:10” will be prompted in

sample information.

●The diluent should be prepared in advance and protected from dust.

●After the mixing of peripheral blood and diluent, it should be placed for 3 minutes, and then

remix before use.

●The diluted sample should be used within 30 minutes.

● The sample should be re-mixed after placing for a period of time before use.

●The stability of the result on pre-dilution mode should be evaluated according to their own

sample number, sample collection method and technical level.

62


4.4 Sample Testing of Whole Blood Mode

4.4.1 Changing Test Mode and Sample No.

In main interface, if the current mode is “Whole Blood”, testing can be carried out directly. Or

switch the current mode to “Whole Blood”.

Note:

The pipeline should be rinsed when “Predilution” is switched into “Whole Blood”.

（a）In main interface, press the . As shown in figure 4-4-1:

（b） In “Mode”, blood sample mode is whole blood or predilution.

（c）The testing mode is “CBC”or“CBC+DIFF”.

“CBC”mode：conduct counting without WBC differential. The result include 14 parameters and

RBC, PLT histogram.

“CBC+DIFF”mode：conduct counting and WBC differential. The result include 24 parameters,

scattergram, histogram and 10 research parameters.

(d) Input the next sample No. in “Sample No.” input box.

(e) Select the reference range in the drop down list of “Reference Range”, default as “General”.

Note：

The maximum digit of sample No. is 15. All number should not be “0”, otherwise, the software

prompts invalid input.

Figure 4-4-1

63


Number to enter "-", but not enter "."

4.4.2 Sample Information Editing

Note：

Edit the waiting sample before analysis.

Click in main interface. As shown in figure 4-4-2:

Figure 4-4-2

4.4.2.1 Information Editing of Single PatientSample Information：refer to 3.2.1.1；

Patient Information：refer to 3.2.1.2；

4.4.2.2 Batch Patient Information Input

In batch patient information input, input one patient information first and then copy the input

patient information, modify part of the information at last. Operations are same as the "3.2.2

Copy Patient Information" "and" 3.2.1 Edit Patient Information "

4.4.3 Sample Testing Steps

Note：

● There should be a space between probe tip and test tube bottom in the process of sample

64


aspiration, otherwise, the accuracy of the aspiration volume may be affected.

● Set the reference range of parameters in “Setting” interface, otherwise, incorrect alarm will be

prompted after testing.

● The default reference range is “Normal”. The alarm prompted after test is according to the

reference range of “Normal”.

Whole Blood Sample Testing

Conduct whole blood sample testing according to the following steps in “Counting Interface”(As

shown in figure 4-4-3):

（a）Check the working mode is “Whole Blood Mode”, the green indicator in the middle of the

front upper cover is bright.

（b）Place the sample under the sampling probe. Make sure the probe can aspirate the mixed

sample.

（ c）Press “Counting” on instrument panel to start the sample testing. The sampling probe

aspirate 20uL sample.

（ d）When the buzzer is heard, the operator can remove the sample. The sampling probe

injects the sample into the counting pool. The instrument will carry out test automatically.

（e）The sampling probe reset after testing, and prepare for next testing. The test result will be

displayed in the chart review of the computer. Meanwhile, the next sample number will plus one

automatically.

Figure 4-4-3

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（f）The instrument will save the test result after test.

（g）Conduct other sample testing according to this process.

（h）Click to enter into query interface, press “Print” or “Batch Print” to print the

report.

Note：

In the process of testing, the interface can be switched to “Picture” “Research Parameter” to

browse the pictures or check the study parameters. But no operation can be conducted. The

data will be saved into the data review after test automatically.

If block or air bubbles occurred, the instrument will set the relative parameter to be invalid.

And prompt the failure on the screen.

The result will be inaccurate if the temperature exceeds the normal working temperature

range of the instrument.

4.4.4 Picture Check

Click “Picture” in figure 4-4-3 to check the pictures of the test results, as figure 4-4-4 shows:

Figure 4-4-4

Histogram of RBC, PLT and WBC; histogram and scattergram of WBC 4 diff will be displayed.

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4.4.5 Research Parameter Check

Click “Research Parameter” in figure 4-4-4 to check 10 research parameters, as figure 4-4-5

shows:

Figure 4-4-5

4.5 Pre-dilution Sample Testing

Check the working mode is “Predilution Mode” in “Counting” interface(as figure 4-4-3 shows),

otherwise, switch the current mode to “Predilution”mode.

Note:

The pipeline will be rinsed after mode switching.

（a）When the green indicator in the middle of the front upper cover is bright, place the diluted

sample under the sampling probe. Make sure the probe can aspirate the mixed sample.

（ b）Press “counting” on instrument panel to start the sample testing. The sampling probe

aspirate 80uL.

（ c）When the buzzer is heard, the operator can remove the sample. The sampling probe

injects the sample into the counting pool. The instrument will carry out testing automatically.

（d）The sampling probe reset after testing，and prepare for next test. The test result will be

displayed in the pictures review of the screen. Meanwhile, the next sample number will plus one

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automatically.

（e）The instrument will save the test result after test.

（f）Conduct other sample test according to this process.

（h）Click to enter into query interface, press “Print” or “Batch Print” to print the

report.

Note：

In the process of testing, the interfaces can be reviewed. But no operation can be

conducted. The data will be saved into the data review after test automatically.

If block or air bubbles occurred, the instrument will set the relative parameter to be invalid.

And prompt the failure on the screen.

The result will be inaccurate if the temperature exceeds the normal working temperature

range of the instrument.

4.5.1 Parameter Alarm

Parameter alarm include the following three situations:

If the result is marked with “H”or“L”, that means the result exceeds the reference range.

If the result displayed as “***”， invalid result or range exceeding can be indicated. If WBC

counting

result is smaller than 0．5*109／L or bigger than 999*109／L，or the pre-dilution result is smaller

than 2*109／L or bigger than 999*109／L, the system will not conduct WBC differential, the

relevant parameter displays as “***”.

If the result is displayed with “?”, then the result is unreliable.

4.5.2 Differential or Abnormal Form Alarm

The instrument can prompt alarm according to the histogram and scattergram. As shown in table

4-1:

（a）WBC abnormity alarm information

Information Meaning Judging Standard

WBC scattergram abnor

mal ?

WBC scattergram abnormal DIFF channel scattergram abnormal

WBC increase Higher WBC counting WBC>18.0*10^9/L

WBC reduction Lower WBC counting WBC<2.5*10^9/L

Neutrophil increase Higher neutrophil counting NEUT#>11.0*10^9/L

Neutrophil reduction Lower neutrophil counting NEUT#<1.0*10^9/L

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Lymphocyte increase Higher lymphocyte counting LYM#>4.0*10^9/L

Lymphocyte reduction Lower lymphocyte counting LYM#<0.8*10^9/L

Monocyte increase Higher Monocyte counting MON#>1.0*10^9/L

Eosinophil increase Higher eosinophil counting EOS#>0.7*10^9/L

Basophil increase Higher basophil counting BASO#>0.2*10^9/L

(b)WBC unreliable alarm information

Left Shift ？ Left shift may be existing.In shift left position of scattergram,

more scatter dots exits.

Immature Cell？ Immature cell exists. The proportion of immature cell is

bigger than the set reference value.

Abnormal Lymphocyte Lymphocyte abnormity exists.Abnormal lymph or non-typical lymph

is bigger than the set reference value

Nucleated red blood cell

/ platelet aggregation

Maybe RBC hemolysis is not

complete, red blood cell is on

immature stage or platelet

aggregation

The scatter dots are condensed

between lymphocyte and ghost cell.

(c)RBC/HGB abnormal alarm information


Abnormal RBC

distribution

Abnormal RBC histogram

distribution

Abnormal RBC histogram

RBC size is different. RBC size is different. RDW-SD>65or RDW-CV>20

Small RBC Smaller MCV MCV<70fL

Big RBC Bigger MCV MCV>110fL

RBC increase RBC increase RBC>6.5*1012/L

Anemia Anemia HGB<100g/L

Low pigment Low pigment MCHC<290g/L

Bimodality RBC bimodality distribution RBC histogram has two or more

peaks.

(d)RBC/HGB unreliable alarm information


RBC or hemoglobin

unreliable？RBC or hemoglobin may be

inaccurate.

Compare the result of hemoglobin

with RBC result

Hemoglobin

abnormity/interference

？

Abnormal hemoglobin maybe

exists, or interference factor

maybe exists.

Calculate and compare the special

analytical parameters.

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(e)PLT unreliable alarm information


PLT increase PLT increase PLT>600*109/L

PLT reduction PLT reduction PLT<60*109/L

PLT distribution

abnormity

PLT histogram distribution

abnormity

PLT histogram abnormity

(f) PLT unreliable alarm information


PLT aggregation？ PLT aggregation maybe

exists.

Calculate and compare the special

analytical parameters.

4.6 Sleeping

The analyzer enters into sleeping status after stop for 30 minutes, and the status information will

be displayed in failure area. Press liquid aspiration key to proceed with operation.

4.7 Rinse and Clog Removal

The analyzer will conduct automatic rinsing(sample flow parts) in each counting process to

ensure that no sample residue, rinse components are as follows:

Internal and external wall of sampling probe；

Counting pool and quantitative tube；

Flow cell

When the analyzer prompt “Aperture Clog”, click “Remove Clog” in “Service-Maintenance”

interface(same as conducting “Zap” and “Backflush” aperture).

4.8 Shutdown

Note：In order to ensure the stability and accurate test result of the instrument. Shutdown operation is

required after 24 hours continuous working. The operator must follow these steps to shut down

the instrument.

Table 4-1

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Shutdown includes mainframe shutdown and exit software.

4.8.1 Shutdown Mainframe

Click " " in main interface. As shown in figure 4-8-1：

Click “OK”, above figure will pop up. After shutdown liquid aspirating, “Shutdown the analyzer ”

will pop up, the instrument will conduct pipe and counting pool rinsing and soaking.The following

box will pop up after the previous two steps:

Figure 4-8-2

·Switch to “O” on the right of the analyzer to finish shutdown.

·Empty the waste solution container after shutdown.

Note:

Click “Re-start” in figure 4-8-2 if more tests are needed.

4.8.2 Exit Software

Figure 4-8-1

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·Click ，or select “Menu”→“Exit System”，the following box will pop up：

Figure 4-8-3

Click “OK” to exit the software to finish the whole shutdown process.

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Chapter 5 Record Query

The instrument will store the result into database automatically after each test. The maximum

storage capacity 100000 (including 24 parameters, 10 research parameters, scattergram and

histogram). The operator can query the sample result, scattergram and histogram of the

database. The result will be covered if the storage number is more than 100000.

Click in main interface to enter into query interface, as figure 5-5-1 shows:

Figure 5-1-1

The result displayed in the base is in testing sequence(The last result is at the first place). The

default mode is list mode.

If the screen can not display all result, press ”Next” or “Previous” to switch the pages. The

position

of the current result and the total number of data base will be displayed in the form of “Pos/Total”

at the bottom of the interface.

5.1 Record Selection

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If the sample with known position needs to be queried, click “Select” in figure 5-1-1, and select

“Condition” in its drop down list , as figure 5-1-2 shows:

Figure 5-1-2

· Input the “Start Record” and “End Record” need to be queried in figure 5-1-2, click “OK”. The

sample will be selected with .

Note:

The input sample position should within the range of sample lib, otherwise, “Input range error,

please input again” will be prompted.

·If “Cancel Selection” is selected in drop-down list, the selection will be canceled.

5.2 Print

The sample results can be printed in sample query interface.

· Single sample Printing：

Click “Print” in figure 5-1-1, if “Preview or not before printing” is selected in “Print Setting”, as the

following figure shows:

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Figure 5-2-1

Click in above figure to print the report.

·Bulk Print：Click “Bulk Print” in figure 5-1-1, as figure 5-2-2 shows:

Figure 5-2-2

Select the test date of the report, and input the start and end sample No. If “Audited” is selected

and “Preview or not before printing” is selected, the report can be previewed, as the following

figure shows:

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Figure 5-2-3

The selected & audited samples will be printed. If “Audited” is not selected, all selected samples

will be printed.

5.3 Query

The data can be queried through different condition. Click “Query” in figure 5-1-1, and select

“Condition” in its drop-down list , as shown in figure 5-3-1.

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Users can select different query conditions to query, including: sample No., barcode No., test

time, test mode, case No., name, gender, department, deliver doctor, auditor and tester. The

results can be queried according to one condition or multi-condition.

5.3.1 Query Accroding to Sample No.

Input the sample No. in the box behind “Sample No.” need to be queried in figure 5-3-1, if the

input sample No. is “14”, click “Query”, the sample results with No. “14” will be displayed, as

figure

5-3-2 shows:

5.3.2 Query According to ID Number

Input the ID No. in the box behind “Barcode” need to be queried in figure 5-3-1, click “Query”, the

results will be displayed.

5.3.3 Query According to Test Mode and Date

In figure 5-3-1, select the start date and end date of the samples need to be queried in the drop-

down list behind test time, and select the corresponding “Test Mode” and “Analysis Mode”, click

“Query”, the records will be displayed.

Figure 5-3-1

Figure 5-3-2

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5.3.4 Query According to Case No.

Input the Case No. in the box behind “Case No.” need to be queried in figure 5-3-1, click

“Query”,

the results will be displayed.

5.3.5 Query According to Name and Sex

Input the name and select the sex of the patient in the box behind “Name” need to be queried in

figure 5-3-1, click “Query”, the results will be displayed.

5.3.6 Query According to Department and Deliver Doctor

Select the department of the sample in the drop-down list behind “Department”, and select the

deliver doctor of the sample in the drop-down list behind “Deliver Doctor” need to be queried in


5.3.7 Query According to Auditor

Select the auditor of the sample in the drop-down list behind “Auditor” need to be queried in


5.3.8 Query According to Checker

Select the checker of the sample in the drop-down list behind “Checker” need to be queried in


Note:

If “Perfect Match” is selected in above query, only perfect match results will be displayed. If

“Perfect Match” is not selected in above query, all results that can meet the input condition will

be displayed.

Take sample No. as an example:

If sample with No. 11, 211, 311 exist, when “Perfect Match”is selected, the input query No. is 11,

only sample No.11 can be queried.11, 211, 311 will be displayed when “Perfect Match” is not

selected.

5.4 CV Calculation

Users can select records among 3-500 to calculate the CV, Mean and SD. If the selected records

is less than 3, the interface will be:

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Figure 5-4-1

Click the No. in front of record(√), and click CV, as figure 5-4-2 shows:

Figure 5-4-2

The repeatability of the results can be checked. If the any parameter of the selected sample is

invalid, then the repeatability of this parameter is invalid.

Click “Exit” in above figure to exit the interface.

5.5 Bulk Audit

The user can conduct bulk audit in result query, click bulk audit in figure 5-1-1, as figure 5-5-1

shows:

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Figure 5-5-1

Select the test date in the drop down list of “Test Date”, and input the start sample No. and end

sample No., click “OK”，the auditor information of audited sample result will be displayed behind

auditor.

5.6 Communication

Click “LIS Comm.” in list review interface to conduct data transmission with LIS

system.

Figure 5-6-1

5.7 Delete

Click “Delete” in figure 5-1-1, and select the records need to be deleted in its drop-down list

, as figure 5-7-1 shows:

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Figure 5-7-1

Click “OK” in above figure to delete the records.

5.8 Export

The exported data can be saved.

Click “Export” in figure 5-3-2, select the data needs to be exported in its drop-down list

, as the following figure shows:

Figure 5-8-1

Input the file name in the input box behind ”File Name”, and select the saving path, click “Save”,

the following box will pop up:

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Figure 5-8-2

Indicates successful data export.

Note:

The exported file should be saved in EXCEL form.

5.9 Chart Query

User can check single record in chart form, in figure 5-1-1, double click the sample result line, as

figure 5-9-1 shows:

Figure 5-9-1

The sample result position and the total number in sample database will be displayed in the

lower side of the interface in “Pos/No.” form.

Current data can be saved, deleted or audited in this interface.

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Chapter 6 Quality Control

Error may occur after long-term using which may lead to unreliable result. Quality control (QC)

provides an effective way to detect error. Only by familiar with the QC theory and practical

operation method, the error impact can be excluded.

In order to ensure the reliability of the result. The daily low, medium and high level control should

be used to conduct instrument control.

This instrument provides three QC method: L-J QC, QC and X-B floating mean methods.

6.1 L-J QC

Under “L-J” QC, the operator can carry out quality control of 24 parameters. The instrument

provides 12 QC documents in order to save quality control parameter and result. Each quality

control document can save up to 400 groups of quality control results. When the number of

quality control is more than 400, the new QC result will cover the old result.

Click “QC” of main interface and select “L-J/Xbar” in , as shown in figure 6-1-

1.

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Figure 6-1-1

6.1.1 Quality Control Setting

6.1.1.1 Lot No. Information SettingQC information can be set through setting button.

Click set, as shown in figure 6-1-2.

(a) Select Document No.

Click the drop down list of document No. to select the document needs QC, the range is 1~12.

(b) QC Lot No. Input

Input the corresponding Control lot No. in the drop-down list of “Lot No.” according to Control

instruction.

(c)Validity Setting:

Click the drop down list of “Validity” to input the validity according to the instruction.

(d)QC Level Selection：

Select QC level (High, Mid, Low)in drop down menu of “Level”. Each lot No. corresponds to one

level.

Click “Save” when above input is completed. “Save Success” will pop up, and click “OK”.

(e) Target Value, SD Input

Input the target value and SD according to the QC instruction.

Note：

Figure 6-1-2

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The input lot No., validity should be the validity marked on the instruction.

QC mode can be modified in “Sample Information” of counting interface shortcut. For the Control

is whole blood, “Pre-dilute” can not be selected in analysis mode.

”Test Mode” is “CBC+5DIFF”， if test mode is “CBC”， as shown “CBC mode can not

count”when counting.

6.1.1.2 Preset ValueThe QC result in QC chart can be used to calculate Mean, SD and CV%. In QC edit, it can be

used as preset value.

(a)Deviation Limit Setting

If the display form of deviation limit or calculation method of deviation limit in pre-set value need

to be adjusted, following these steps:

Click “Set” in main menu, select “QC Setting” in its left, as figure 6-1-3 shows:

Calculation method and range selection of deviation:

When” Absolute Value” calculation method is selected, the input deviation limit will be displayed

in the form of absolute value. “Range” will use two times the standard deviation (2SD) or 3 times

the standard deviation (3SD) as the deviation limit;

When“Percent”calculation method is selected, the input deviation limit will be displayed in the

form of percent. “Range”will use 2 times the variation coefficient（2CV） or 3 times the variation

coefficient（3CV）as the deviation limit.

Click “Apply” in figure 6-3, the preset value is obtained according to the set method, and it is

Figure 6-1-3

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taken as the target value and deviation limit of current QC document. The corresponding position

of the parameter will be displayed in figure 6-1-2.

(b)If abnormal QC point occurs, preset value can be obtained after abnormal point deleting. The

operating steps are as follow:

Figure 6-1-4

Click “OK” of above figure, the screen will be switched into QC interface, as figure 6-1-5 shows:

Figure 6-1-5

· If the second point on the left is abnormal point, click it, the red cursorline is on the second

point, click “Delete”, the selected point will turn into “Blue”. Use the same method to delete the

abnormal points. The blue point will not be counted during calculation.

· Click “Calculation” after the points are deleted, the screen will return to”Setting” interface, and

the result will be displayed.

· If the valid QC point number is less than 3, click “Preset Value”, figure 6-1-6 will pop up:

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Figure 6-1-6

·If the above operation is found to be wrong, click the deleted point, and click “Add”, the blue

point will turn into red or green(normal point).

Note:

Valid QC points are taken as reference and deviation limit when taking preset value.

6.1.2 QC Counting

Click QC count in figure 6-1-5 to enter QC counting interface, as shown in figure 6-1-7.

The specified Control of DIRUI should be used to avoid QC result error.

See the instruction for the use of Control.

The result will not be reliable when analyzer failure occurs.

● QC Counting

Ensure the mode is “Whole Blood”.

Place the mixed Control under the sampling probe. Press “Sample Aspiration” to start QC

Figure 6-1-7

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counting.The sampling probe will aspirate 20ul Control automatically to conduct QC counting.

Figure 6-1-8

The result will be displayed on the screen.

If the result is lower than the lower limit of the software or higher than the display range, the

following box will pop up:

Figure 6-1-9

Click “Cancel” in above figure, this result will be deleted.

● QC Data Query

The stored QC result can be queried through button Next, Previous under Position/Total Number

after QC counting.

6.1.3 QC Result Review

Click QC Graph in figure 6-1-7 to enter review interface. As shown in figure 6-1-10:

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(a) QC Graph Setting：

Click Setting in “QC Graph” interface to set the parameters or move the display position, as

figure 6-1-11 shows:

Figure 6-1-11

·QC Item Setting：

Select the parameter name in figure 6-1-1, click “OK”, only the selected parameter will be saved.

·QC Item Moving：

Figure 6-1-10

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If the parameters need to be moved, select the parameter need to be adjusted(the selected line

is blue), click “Move Up”, ”Move Down” to move the selected parameter.

(b)Explanation of QC result review interface：

If QC counting number is less than 3, the right side of QC chart will not display the QC result.

The abscissa indicates the QC counting number. The vertical axis indicates QC counting result.

Vertical line marked for the same set of counting data. For each parameter, its QC chart can

display up to 31 points.

For each parameter, the three numbers on the left of the QC chart correspond to the three

boundaries of QC chart. From top to bottom, they represent the upper limit, target value and

lower limit.

Upper limit：Control reference value + deviation limit

Target value: Control reference value

Lower limit：Control reference value - deviation limit

For each parameter, the three number on the right of the QC chart represent Mean, SD and CV

% respectively.

(c)Point explanation of QC chart

The points are QC results, they are connected by lines.

“Green Point” indicates the QC result is within the range. “Red Point” indicates the QC result is

not within the range.

(d)If the point is not within the range, conduct the following steps.

Check the target value and deviation limit.

Check whether the background test is normal.

Conduct QC again if the above two points are normal. If abnormity remains, conduct QC

counting after calibration.

Contact DIRUI’s after sales service department if abnormity remains after calibration.

(e)QC chart printing：

Click Print in figure 6-1-10, if “Preview before print” is selected in print setting, preview can be

conducted before printing, as the following figure shows:

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Figure 6-1-12

Connect the printer, click to print the report.

6.1.4 QC List

Different QC documents can be queried.

Click “QC List” in figure 6-1-10, and select the QC document No. in the drop down menu of

“Document No.” to enter the interface of figure 6-1-13

.

Figure 6-1-13

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(a) Delete All：The operator can delete all QC results of current QC document.

Click “Delete All” in figure 6-1-13, as figure 6-1-14 shows:

Figure 6-1-14

Click “Yes”, the interface will display “Delete Succeed”, which indicates that all QC results are

deleted.

(b)Delete：The operator can delete some QC results of current QC document.

Select the QC data need to be deleted in figure 6-1-13, click “Delete”, as figure 6-1-14 shows,

click “Yes”, the interface displays “Deleting Succeed”, which indicates the selected QC results

are deleted.

(c)Print：The operator can print the QC counting result of current QC document.

(d)Export：The operator can export the QC counting result of current QC document.

(e)Communicate：The operator can transmit the QC counting result of current QC document to

LIS.

6.2 QC

X QC：the mean value of two testing result will be one QC point in the QC chart.

The operation is same as “6.1 L-J QC “.

6.3 X-B QC

X-B floating average method is proposed by Dr. BrianBull. Through monitoring stability of red

blood cell parameter, such as MCV, MCH, MCHC, etc. to monitor instrument performance. It

belongs to the quality control without control. Together with the quality control with control, they

all belong to instrument performance monitoring method which can reflect instrument

performance from different aspects. They are not mutually replaceable. The X-B quality control is

92


recommended when the daily sample is greater than 100 per day. This quality control method

requires the use of random sample, therefore, the classified sample is not suitable. It offers the

upper and lower limit to form a reference range. Observe the changing trend of result within the

reference range.

This instrument conduct X-B QC toward MCV、MCH、MCHC. The sample number in each group

can be set as 20-200. The sample is come from normal counting result of the instrument, without

classifying whole blood and pre-dilution mode.

Calculation is needed before testing, because X-B reference value is obtained through analyzing

a large number of random sample.

6.3.1 QC Setting

The QC parameter need to be set before X-B QC analysis.

(a）Click “Setting” in main menu, and select “QC Setting” in the left menu, open ”X-B” interface,

as figure 6-3-1 shows:

Figure 6-3-1

Sample No. selected for each X-B point can be 20-200, the recommanded number is 20.

Click ON under “X-B QC ”, click “Apply”, “Saving succeed” will pop up, click “OK”.

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（b）Click “QC” in above menu, and select “X-B” in , as figure 6-3-2 shows:

Figure 6-3-2

Target and Deviation Limit Input:

Click the target and deviation limit to input them.

Target：Reference of different area may be different, so the sample number should reach certain

number(more than 500), the mean should be taken as target of X-B QC.

Deviation Limit: 3%-5% of target should be taken as deviation limit.

Note:

Target and deviation limit can not be blank.

(c)Click “Save” after setting, “Saving Succeed” will pop up, click “OK”.

6.3.2 QC Counting

The operator can conduct X-B QC upon normal counting result. The system will conduct X-B QC

calculation after 20-200 samples(Set according to the sample number/group ). Each X-B QC

parameter will get a QC point. It will be stored in X-B QC chart and X-B QC list.

6.3.3 QC Graph Review

Click “QC Graph” in figure 6-3-2 to enter into X-B QC graph review interface, as shown in figure

94


6-3-3.

(a)QC graph explanation:

The abscissa is the counting result number. The vertical axis is the result.

For each parameter, the three numbers on the left of the QC graph correspond to the three

boundaries of QC graph. From top to bottom, they represent the upper limit, target value and

lower limit.

Upper limit：Control reference value + deviation limit

Target : Control reference value

Lower limit：Control reference value - deviation limit

For each parameter, the three number on the right of the QC grapch represent Mean, SD, and

CV% respectively.

(b)Point of QC graph explanation

The points are QC results, they are connected by lines.

“Green Point” indicates the QC result is within the range. “Red Point” indicates the QC result is

not within the range.

(c)If the point is not within the range, conduct the following steps.

Check the target value and deviation limit.

Check whether the background test is normal.

Contact DIRUI’s after sales service department if abnormity remains after calibration.

(d)QC data checking

Figure 6-3-3

95


The QC result can be checked through previous and next. Corresponding QC result

will be displayed under the parameter name. The position of the QC point and the total QC result

number will be displayed in the form of “Position/Total Number” at the lower left side of the

interface.

6.3.4 QC List Review

Click QC list in figure 6-3-3 to enter the X-B QC list review interface, as shown in figure 6-3-4.

Figure 6-3-4

(a)Delete：Click the QC data behind corresponding No., the line will turn blue, click “Delete”, as

figure 6-3-5 shows:

Figure 6-3-5

Click “Yes” in above figure, “Delete Succeed” will be displayed, the selected records will be

deleted.

Note:

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Reference range and deviation limit can not be deleted.

(b)Delete All：Click “Delete All”, as figure 6-3-6 shows:

Figure 6-3-6

Click “Yes” in above figure, “Delete Succeed” will be displayed, the all records will be deleted.

(c）Export：Click “Export” to enter figure 6-3-7:

Figure 6-3-7

Input the document name in the input box behind “File Name”, and select the saving path, click

“Save”.

Note：The exported document will be saved in EXCEL form.

(d） LIS Transmission：Click “LIS Transmission”, the data will be transmitted to LIS, as the

following figure shows:

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Figure 6-3-8

Chapter 7 Calibration

Calibration of the instrument is to ensure the accuracy of the results. Calibration must be carried

out before test.

7.1 Calibration Frequency

The instrument calibration has been conducted in the factory. Calibration is still required in the

following three cases:

● Before first use

● After main part replacing

● Obvious deviation exits in QC running

7.2 Calibration Method

The instrument offers three calibration methods: manual calibration, calibrator calibration and

fresh blood calibration. In automatic calibration and fresh blood calibration, the relative

calibration will be conducted automatically by the instrument, and the calibration coefficient will

be stored in “manual calibration” interface.

7.2.1 Preparation before Calibration

Conduct the following checks before calibration. Contact Dirui's after-sales service department

for any problem.

· Check the instrument and the reagent to ensure enough reagent to finish whole calibration

process. If the reagent is finished in the process of calibration, calibration should be conducted

again.

· Conduct background testing. If the blank test value exceeds the background range, solution

should be seeked to ensure the result meet the requirement.

· The Control and reagent specified by Dirui company should be used. The corresponding

operation should refer to the Control and reagent instruction.

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7.3 Calibration with Calibrator

Note: calibration with calibrator should be conducted under whole blood mode.

Click “Calibration” of above menu, and select “Calibrator Calibration” in ,

as figure 7-3-1 shows:

Figure 7-3-1

（a）Calibrator Reference Value Input：

Click the corresponding line of “Reference”, input the value.

（b）Calibration Counting：

Put the prepared Calibrator under the sampling probe(No less than 0.5 mL) after reference value

input. Press “Sample Aspiration”, the sampling probe will aspirate 20uL Calibrator and start

calibration counting automatically.

Figure 7-3-2

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After obtaining 3 or more counting results, the instrument will carry out CV and calibration

coefficient calculation and save the calibration coefficient result. Save after 5 times counting is

recommended. As the increase of calibration times, CV and calibration coefficient will be

updated.

The following box will pop up if the results obtained beyond the scope.

Click “OK” to close the box and clear the result of this counting. The result will be displayed on

the calibration interface only if the counting result is valid.

When saving the counting result after obtaining 3 or more counting result, if the calibration

coefficient of certain parameter is not within 75%-125%, click “Save”, the following box will pop

up:

Figure 7-3-4

Operator should check the reference value input, if the reference value input is correct, operator

delete calibration results, re-run the calibration count.

（c）Calibration Result Deleting.

If any abnormal result occurs, click “Test Result” on the left after test, × will be marked, indicating

this result is not counted during CV, mean, calibration coefficient calculation. If this result

Figure 7-3-3

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deletion is not needed after test, click “Test Result” again(mark √ ), indicating this test result is

valid.

If this result is invalid, click “Delete” to delete the result.

（d）Calibration coefficient saving：

Click “Save” in figure 7-3-1 after 5 times counting, the following box will pop up.

Click “OK” to save the calibration coefficient. It will be stored into calibration coefficient of

“Manual Calib” interface. As figure 7-3-6 shows:

Figure 7-3-6

7.4 Fresh Blood Calibration

7.4.1 Fresh Blood Preparation.

Use EDTA-K2 (1.5—2.2mg／mL blood) antifreeze vacuum tube to collect venous blood sample.

Mix the venous blood and anticoagulant immediately.

Prepare 3-5 copies of normal fresh blood by using the above method.

7.4.2 Fresh Blood Calibration

Note: Fresh blood calibration need to be conducted under “Whole Blood” and “Pre-dilution”

testing mode.

Figure 7-3-5

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Click “Fresh Blood Calib” in figure 7-3-1 to enter fresh blood calibration interface, as shown in

figure 7-4-1.

7.4.2.1 Whole Blood Calibration

（a）Select the number of fresh blood calibration in the drop down list behind “No.” To reselect

its “No.” after each fresh blood sample is tested for 5 times.

（b）Put the prepared fresh blood in the instrument to test three times, and calculate the mean

value. The mean value will be taken as reference value and input in figure 7-4-1.

（c）Put the fresh blood under sampling probe, and press “Sample Aspiration”, the sampling

probe will aspirate 20uL fresh blood and start calibration counting automatically.

Figure 7-4-2

（d）After obtaining 3 or more counting results, the instrument will carry out CV and calibration

coefficient calculation. 5 times counting is recommended. As the increase of calibration times,

Figure 7-4-1

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CV and calibration coefficient will be updated.

（e）Analyzer will carry out different process according to different results.

The following box will pop up if the results obtained beyond the scope.

Click “OK” to close the box and clear the result of this counting. The result will be displayed on

the calibration interface only if the counting result is valid.

When saving the counting result after obtaining 3 or more counting result, if the calibration

coefficient of certain parameter is not within 75%-125%, click “Save”, the following box will pop

up:

Figure 7-4-4

Operator should check the reference value input, if the reference value input is correct, operator

delete calibration results, re-run the calibration count.

（f）Calibration Result Deleting.

If any abnormal result occurs, click “Test Result” on the left after test, × will be marked, indicating

this result is not counted during CV, mean, calibration coefficient calculation. If this result

deletion is not needed after test, click “Test Result” again(mark √ ), indicating this test result is

valid.

Figure 7-4-3

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If this result is invalid, click “Delete” to delete the result.

（g）Calibration coefficient saving：

Click “Save” in figure 7-4-1 after 5 times counting, the following box will pop up.

Click “OK” to save the calibration coefficient. It will be stored into calibration coefficient of

“Manual Calibration” interface.

7.4.2.2 Peripheral Blood Calibration

Refer to 4.3.2 for peripheral blood preparation.

Refer to 7.4.2.1 for operation.

7.5 Manual Calibration

The calibration coefficient displayed on the screen is the calibration coefficient saved after

calibration with calibrator or fresh blood calibration.

Click “Manual Calibration” in figure 7-4-1 to enter manual calibration interface. As shown in figure

7-5-1.

Figure 7-4-5

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（a） Click the corresponding line under “Calibration Coefficient” when the calibration

coefficient needs adjustment, and input the calibration coefficient, click “Save”, “Save

succeed” will pop up, click “OK”.

7.6 Calibration Log

The software registers information of each calibration.

Click “Calib History” in figure 7-5-1 to enter calibration log interface, as shown in figure 7-6-1.

Figure 7-5-1

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The date, mode, calibration method and detail test value of latest 30 times calibration will be

displayed. If calibration counting is more than 30 times, the previous calibration result will be

covered.

Query: Operator can query the calibration log according to log date, username, calibration mode

and calibration method.

Chapter 8 Service

In order to ensure the normal running of the instrument, routine maintenance is required. The

instrument will prompt the user to conduct maintenance after testing a certain number of sample

or a continuous working period. The service menu in the instrument offers routine maintenance

methods and failure solutions, but users should make their own maintenance plan according to

daily sample number, operating environment, running time, etc. to reduce the impact of various

factors and ensure the safe, stable and effective running of the instrument.

Note:

● Improper maintenance may damage the instrument. The manual must be followed in

maintenance.

● Contact Dirui's after-sales service department for unclear answers of the manual.

Figure 7-6-1

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8.1 Maintenance Guide

8.1.1 Regular Maintenance

● Daily:

QC should be conducted before daily analyzing. Refer to chapter 6 for QC operation.

If the instrument is on for 24 hours, daily “WBC Pool Rinsing", “RBC Pool Rinsing”, “DIFF Pool

Rinsing” operation should be conducted(service-maintenance-rinsing).

● Every week:

If normal shutdown operation is conducted every day, " Detergent Soaking" （WBC Pool, RBC

Pool, DIFF Pool）should be conducted every week.（service-maintenance）.

● Every month:

Swab rinsing should be conducted each month if daily shutdown is conducted(Service-

Maintenance-Rinsing).

8.1.2 Maintenance in Need

● If the counting pool has been contaminated, conduct “Counting Pool Rinsing".

●When the analyzer has not been used for 2 weeks or more, repalce the reagent with distilled

water, conduct "Rinse Pipeline" of "Maintenance", and stop the distilled water, conduct "Empty

Pipeline", and place the analyzer at a clean place.

● When the instrument prompt "clog" failure, press “Remove” to conduct manual remove or

conduct " Zap " and " Backflush ".

● Carry out priming if it has not been used for a long time.

● The instrument will prompt “Soaking with Detergent” if the set counting number of software has

been conducted.

●The reliable results can be obtained under the condition of normal working environment and

state.

● See the failure solution if other failure information is prompted.

8.2 System Status

System status is used to display the current status. Basic status, system version can be checked

in this interface.

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8.2.1 System Version

Click service, and click in front of System Version, and select Software, the screen displays

as figure 8-2-1:

Version number of software and algorithm library is displayed.

Select Mainboard, as figure 8-2-2 shows:

Figure 8-2-2

Version of software and hardware, upgrade pack are displayed.

Figure 8-2-1

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Version number of control board, collection board, temperature control board, sampler control

board and mechanical version can be checked by using the same method.

Select “Instrument Information” in its drop down menu, as figure 8-2-3 shows:

Figure 8-2-3

It has been set before delivery. Therefore, it can only be checked.

Note:

Version No. of above figure is only for reference.

8.2.2 Basic Status

Select “Basic Status” in figure 8-2-2, the screen display as figure 8-2-4:

Figure 8-2-4

Status explanation:

(a)Temperature：Real-time temperature of reaction pool, working environment and laser, and

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also the normal range.

(b)Pressure：Pressure of pressure reducing valve and normal pressure range.

(c)Voltage：Display 55V, 5V, voltage of WBC aperture, RBC aperture and normal range.

(d)Current：Display the normal range and power adjust valve of laser current.

8.3 Mechanical Detect

Click in front of “Detect” in figure 8-2-4, and select “Mechanical Detect”, as shown in figure

8-3-1:

Figure 8-3-1

8.3.1 Motor Detect

When some moving parts failure occur, motor detection can be conducted to judge the failure.

The following motors detection has been set in this program: Y axis motor, X axis motor, diluent

motor, lyse motor, whole blood aspiration motor and test motor. Click “Test”, the result will be

displayed on the screen(Succeed or Failed).

8.3.2 Valve Detection

Valve failure will lead to abnormal work of the instrument. Therefore, value detection is an

important way to solve pipeline failure.

Its operation is as follow:

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Click the No. of the valve(No. of figure 8-4 indicate valves), the analyzer will conduct valve

detection automatically. Valve ON sound indicates normal valve. The valves with grey No. can

not be detected.

8.3.3 Pump Detection

Click “Positive Pressure” or “Negative Pressure” to check the pump voltage.

Note:

Valve detection and voltage detection can not be conducted at the same time.

Click “Exit” after test to exit the interface.

8.4 System Maintenance

In order to protect the normal and accurate running of the analyzer, the software provides a

number of maintenance functions.

8.4.1 Replacement / Priming

Note:

Carry out background test after diluent, lyse replacement. Sample test can be conducted when

the background result is within normal range. The following range is the normal range of

background test:

a）RBC≤0.05×1012/L

b）WBC≤0.5×109/L

c）HGB≤2g/L

d) PLT≤10×109/L

Click in front of “Maintain” in figure 8-3-1, and select “Replace/Prime”, as figure 8-4-1 shows:

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Figure 8-4-1

（a）FDO Lyse Replacement：

Click Replace FDO when bubble exits in FDO pipeline, or FDO reagent is polluted, or FDO

reagent has been used up.

Click OK，pop up progress bar as shown in Figure 8-4-3：

Figure 8-4-2

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Figure 8-4-3

After replacing FDO lyse, the following box will pop up:

Figure 8-4-4

Click “OK” to finish the replacement of FDO.

Click “Cancel” in figure 8-4-2 to cancel FDO replacement.

（b）FDT Lyse Replacement：

Click Replace FDT when bubble exits in FDT pipeline, or FDT reagent is polluted, or FDT

reagent has been used up. The confirm interface will pop up. Click OK，pop up progress bar

”Replacing FDT About 3 mins…”, After replacing FDT lyse, “Operation finished” box will pop up,

click OK to finish the replacement.

Click “Cancel” to cancel FDT replacement.

（c）SLS Lyse Replacement：

Click Replace SLS when bubble exits in SLS pipeline, or SLS reagent is polluted, or SLS

reagent has been used up. The confirm interface will pop up. Click OK，pop up progress bar

”Replacing SLS About 3 mins…”, After replacing SLS lyse, “Operation finished” box will pop up,

click OK to finish the replacement.

Click “Cancel” to cancel SLS replacement.

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（d）Diluent Replacement：

Click Replace Diluent when bubble exits in Diluent pipeline, or Diluent is polluted, or Diluent has

been used up. The confirm interface will pop up. Click OK，pop up progress bar ”Replacing

Diluent About 5 mins…”, After replacing Diluent, “Operation finished” box will pop up, click OK to

finish the replacement.

Click “Cancel” to cancel Diluent replacement.

（e）FDO Priming：

Click Prime FDO when FDO Lyse being emptied. The following box will pop up:

Click OK, as shown in Figure 8-4-6：

Figure 8-4-6

The following box will pop up after FDO priming.

Figure 8-4-7

Figure 8-4-5

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Click OK to finish the priming of FDO.

Note: In the "fault information area", clear the corresponding error message, the instrument

automatically conduct FDO lyse priming when the software prompt FDO insufficiency.

(f) FDT Priming:

Click “Prime FDT” after FDT is emptied. And the operation should be conducted as the prompts.

Or: In the "fault information area", clear the corresponding error message, the instrument

automatically conduct FDT lyse priming when the software prompt FDT insufficiency.

(g) SLS Priming:

Click “Prime SLS” after SLS is emptied. And the operation should be conducted as the prompts.


automatically conduct SLS lyse priming when the software prompt SLS insufficiency.

(h) Diluent Priming:

Click “Diluent Priming” after Diluent is emptied. And the operation should be conducted as the

prompts.


automatically conduct Diluent priming when the software prompt Diluent insufficiency.

(i) Detergent Priming:

Click “Detergent Priming” after Detergent is emptied. And the operation should be conducted as

the prompts.


automatically conduct Detergent priming when the software prompt Detergent insufficiency.

8.4.2 Rinsing

Select “Rinse” in figure 8-4-1, as figure 8-4-8 shows:

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(a) Conduct WBC pool rinsing when the background test value of WBC or HGB parameter is

abnormal. Click Rinse WBC in figure 8-4-8. As shown in figure 8-4-9.

Click OK，progress bar will pop up as shown in Figure 8-4-10：

Figure 8-4-10

“Operation Complete” will pop up after WBC pool rinsing, click OK to finish the whole process.

Figure 8-4-8

Figure 8-4-9

116


Click “Cancel” in figure 8-4-9 to cancel WBC pool rinsing.

(b) Conduct RBC pool rinsing when the background test value of RBC or PLT parameter is

abnormal. Click Rinse RBC in figure 8-4-8. Confirm box will pop up, click OK，progress bar will

pop up. “Operation Complete” will pop up after RBC pool rinsing, click OK to finish the whole

process.

Click “Cancel” to cancel RBC pool rinsing in confirm box.

(c) Conduct DIFF pool rinsing when the WBC-diff parameter is abnormal. Click Rinse DIFF in

figure 8-4-8. Confirm box will pop up, click OK，progress bar will pop up. “Operation Complete”

will pop up after DIFF pool rinsing, click OK to finish the whole process.

Click “Cancel” to cancel DIFF pool rinsing in confirm box.

(d) In order to avoid sampling component contamination, swab rinsing should be conducted after

one month’s running.

Click “Rinse Swab” in figure 8-4-8. The confirm box will pop up, click OK, as figure 8-4-11 shows:

Figure 8-4-11

Place the detergent used for probe rinsing under sampling probe and press sample aspiration

key. Progress bar will pop up. “Operation Complete” will pop up after swab rinsing, click OK to

finish the whole process.

Click “Cancel” to cancel swab rinsing in confirm box.

(e) Bubble may exists in flow cell when magnified cell mass exists in scattergram and the

background testing value of WBC parameter is higher than normal value. “Sheath Pool Rinsing”

should be conducted at this time. The operation is as follow:

Click Rinse Sheath Flow Pool in figure 8-4-8. Confirm box will pop up, click OK，progress bar

will pop up. “Operation Complete” will pop up after rinsing, click OK to finish the whole process.

Click “Cancel” to cancel sheath pool rinsing in confirm box.

(f)If bubble exists in sample aspiration pump or the test values are lower after reagent

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replacement. “Debubble Sample Pump” should be conducted.

Click “Debubble Sample Pump” in figure 8-4-8. Confirm box will pop up, click OK，progress bar

will pop up. “Operation Completed” will pop up after debubble, click OK to finish the whole

process.

Click “Cancel” to cancel debubble in confirm box.

8.4.3 Maintenance

Click “Maintain” in figure 8-4-8, as shown in figure 8-4-12.

8.4.3.1 Emptying

In order to avoid liquid spill during pipeline maintenance, empty should be conducted first. Taken

waste liquid buffer bottle as an example:

(a)Click Empty WC to empty the corresponding bottle and the pipeline. The following box will pop

up.

Figure 8-4-12

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Click OK in above figure to conduct empty WC. Progress bar will pop up. “Operation Complete”

will pop up after emptying, click OK to finish the whole process.

Click “Cancel” to cancel the emptying in confirm box.

The operation of “Empty PK”, “Empty WBC”,“Empty RBC”,“Empty DIFF”,“Empty FDO”,“Empty

FDT”,“Empty SLS” and“Empty Diluent” is same as “Empty WC”.

After emptying waste pool 1, return to the interface shown in Figure 8-19.

(b) Click “Empty Pipeline” in figure 8-4-12 when the analyzer will not be used for 1-2 days. Place

the analyzer at a clean position after pipeline emptying.

(c)Replace the reagent with distilled water when the analyzer will not be used for more than 1

week. Click “Package Clean Pipe” in figure 8-4-12. Place the analyzer at a clean position after

above two steps.

8.4.3.2 Aperture

Aperture clog remove, zap and backflush should be conducted in order to clear the debris in

aperture.

Click “Zap”, the following box will pop up:

Figure 8-4-14

Click “OK” in above figure, to clean the aperture through high-voltage direct current. The

progress bar will pop up meanwhile.

Click “Backflush”, the confirm box will pop up, click “OK” to flush it. The progress bar will pop up

Figure 8-4-13

119


meanwhile.

Together with zap, the RBC aperture clog can be removed.

Click “Clog Remove”, the confirm box will pop up, click “OK” to zap and flush the aperture. The

progress bar will pop up meanwhile.

8.4.3.3 Soaking with Detergent

In order to ensure the accuracy of the test result, detergent soaking of WBC pool, RBC pool and

DIFF pool assembly should be conducted in the following conditions:

·Scattergram of test result is abnormal.

·Aperture clog failure.

·Detergent soaking prompted by the software.

(a)RBC Pool Soaking：

RBC pool soaking should be conducted every other month, the operation is as follow:

Click “RBC Pool” in figure 8-4-12, as figure 8-4-15 shows:

Figure 8-4-15

Click “OK” in above figure, as figure 8-4-16 shows:

Figure 8-4-16

Place the prepared probe detergent under sample probe, and press aspiration key. The

detergent will be dispensed into RBC pool, as the following figure shows:

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Figure 8-4-17

The following box will pop up after soaking:

Figure 8-4-18

Click “Next” in figure 8-4-18 to empty RBC, as the following figure shows:

Figure 8-4-19

Operation has been finished after emptying, as the following figure shows:

Figure 8-4-20

Click “OK” to finish the whole process.

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(b)WBC Pool Soaking：

WBC pool soaking should be conducted every other week, the operation is as follow:

Click “WBC Pool” in figure 8-4-12, as figure 8-4-21 shows:

Figure 8-4-21

Click OK in above figure, as 8-4-16 shows. Place the prepared probe detergent under sample

probe, and press aspiration key. The detergent will be dispensed into WBC pool, as the following

figure shows:

Figure 8-4-22

Click “Next” in figure 8-4-18 to empty WBC, as the following figure shows:

Figure 8-4-23

(c) DIFF Pool Soaking：

DIFF pool soaking should be conducted every other week, the operation is as follow:

Click “DIFF Pool” in figure 8-4-12, as figure 8-4-24 shows:

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Figure 8-4-24

Click OK in above figure. The DIFF pool will be emptied. As figure 8-4-25, 8-4-26 shows:

Figure 8-4-25

Figure 8-4-26

Aspirate 1ml shutdown liquid with injector, and add it into DIFF pool, as figure 8-4-27 shows:

Figure 8-4-27

Click “OK” in figure 8-4-26 after liquid adding. As figure 8-4-28 shows:

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Figure 8-4-28

Figure 8-4-29 will pop up after soaking, indicates whole process is finished.

Figure 8-4-29

8.4.4 Reagent Registration

Click “Reagent Register” in figure 8-4-12, the screen display as figure 8-4-30 shows:

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Figure 8-4-30

（a）Input the barcode information manually：

Manual barcode information input can be conducted if the external barcode scanner is not

connected.

Click barcode input box in figure 8-4-30 to input the information according to the reagent

package.

Click OK after input.

Left times: Scanning a barcode information for each, the remaining number will change

accordingly (with the reagent in proportion to the size of bottle).

（b）Scan barcode information

Connect the barcode reader( connect the data wire of barcode reader with computer) , click the

input box behind “Barcode” to turn into available status, scan the barcode outside the package

box with barcode reader, screen prompts "× × × register ok" and the barcode.

（c）Prompts for scanning failure

The following information will be prompted if scanning failed:

Figure 8-4-31

Input the information after checking if above condition occur. Contact DIRUI or his distributor for

continuous failure.

The following box will pop up if the barcode has been used:

Figure 8-4-32

Change another bottle of reagent if above condition happened.

Note:

Do NOT stare at the scanning beam during analyzer running to avoid eye injury.

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8.5 Replacement of Wearing Components

8.5.1 Replace Syringe Pump

Syringe pump should be replaced after long time using.The detail steps are as follow:

Counting for 100 samples/day, sample aspiration pump, test pump and lyse pump(including SLS

pump, FDO pump and FDT pump)should be replaced once in 21 months. Pump used for diluent

should be replaced once in 14 months.

The pump positions are as follow:

Figure 8-5-1

Figure 8-5-2

SLS Syringe Pump FDO Syringe Pump FDT Syringe Pump Diluent Pump ① ② ③ ④

Test Pump⑤

Sample Pump

①②③

④⑤

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8.6 System Log

Click “Log” in main interface, and select “Error Log” in its drop-down list , as

figure 8-6-1 shows:

Figure 8-6-1

The operator can also select “Operation Log” and “Failure Log” in its drop-down list for checking.

127


Chapter 9 Instrument Transportation and Storage

9.1 Transportation Requirement

The instrument should be protected from water, severe vibration and squeeze. Handling, loading

and unloading should be carried out lightly.

9.2 Storage Requirement

Altitude: below 2000 meters.

Temperature Range: -10 ~ 40 . ℃ ℃

Relative Humidity: 30% ~ 75%.

Barometric Pressure: 76kPa ~ 106kPa.

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Chapter 10 Failure Handling

This chapter describes various types of possible failure, the reason of the failure, and the

solutions.

Note：

Test the result in case of failure may cause inaccurate result. If alarm is prompt in the process of

testing, failure solution should be adopted first.

10.1 Overview

See the following relative failure solution if failure occur during working process.

Alarm information will be prompted in failure information area if failure occurs. Click the failure,

figure 10-1-1 will pop up:

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Figure 10-1-1

Failure information name and help will be displayed.

Name of failure information will be displayed according to the order of the failure.

The failure solution can be checked in detail information.

Press “Clear” to clear the failure information. Click “Exit”.

10.2 Failure Information and Solution

Alarm Information Solution

Diluent bottle is empty.

1.Check the diluent.

2. Replace a new bottle of diluent if there is no diluent. Click “Clear” to

prime diluent.

3.Check the float switch if diluent is sufficient. Replace it if it is not usable.

HGB background

exceeds range.

1.Please check whether the diluent has been polluted.

2.Click “Clear” to solve it if the diluent is not polluted.

5V voltage exceeds

range.

1.Click “Clear” to solve it.

2.Replace the circuit board if problem can not be solved.

WBC aperture voltage

exceeds range.



55V voltage exceeds

range.



RBC aperture voltage

exceeds range.



Laser current exceeds

range.



FDO empty 1.Check the FDO.

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2. Replace a new bottle of FDO if there is no FDO. Click “Clear” to prime it.

3.Check the float switch if FDO is sufficient. Replace it if it is not usable.

Lyse motor error 1.Click “Clear” to solve the problem.

2.Check lyse motor if problem is not solved. Contact service engineer of

DIRUI if lyse motor is not available.

Lyse motor sensor

error

1.Click “Clear” to solve the problem.

2.Check lyse motor sensor if problem is not solved. Contact service

engineerof DIRUI if lyse motor sensor is not available.

Dilluent buffer bottle

empty

1.Check the diluent.

2.Replace a new bottle of diluent if there is no diluent. Click “Clear” to prime

diluent.

3.Check the float switch if diluent is sufficient. Replace it if it is not usable.

4.Check valve 6 or 12 if float switch is working well. Contact service

engineer of DIRUI if valve is not available.

Voltage error

1.Click “Clear” to solve this problem.

2.Check the air pipes connection.

3.Check the air pump if this problem remains. Contact service engineer of

DIRUI if air pump is not available.

4.Contact engineer to adjust the voltage regulating valve if this problem

remains.

Y axis motor sensor

error


2.Check Y axis motor sensor if problem is not solved. Contact service

engineer of DIRUI if Y axix motor sensor is not available.

Diluent motor error


2.Check diluent motor if problem is not solved. Contact service engineer of

DIRUI if diluent motor is not available.

Diluent motor sensor

error


2.Check diluent motor sensor if problem is not solved. Contact service

engineer of DIRUI if diluent motor sensor is not available.

SLS empty

1.Check the SLS.

2. Replace a new bottle of SLS if there is no SLS. Click “Clear” to prime it.

3.Check the float switch if SLS is sufficient. Replace it if it is not usable.

Data collection board

verification error


2.Check data collection board if problem is not solved. Contact service

engineer of DIRUI if data collection board is not available.

Data collection board is

not connected


2.Check the connection of data collection board.

3.Check whether the board is damaged if failure remain exists. Contact

service engineer of DIRUI if board is damaged.

Laser over-temperature 1.Click “Clear” to solve the problem.

2.Check whether the heater is damaged if failure remain exists. Contact

service engineer of DIRUI if heater is damaged.

3.Check whether the thermistor is damaged if failure remain exists. Contact

service engineer of DIRUI if thermistor is damaged.

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4.Check whether the thermal protector is damaged if failure remain exists.

Contact service engineer of DIRUI if thermal protector is damaged.

Laser low-temperature








Laser temperature

sensor is not

connected


2.Check the connection of temperature sensor.

3.Check whether the sensor is damaged if failure remain exists. Contact

service engineer of DIRUI if sensor is damaged.

Room over-

temperature


2. Please make sure the ambient temperature is within normal range

[15，30] .℃3.Replace the temperature sensor if failure remains.

Room low-temperature


2. Please make sure the ambient temperature is within normal range

[15，30]℃.3.Replace the temperature sensor if failure remains.

Room temperature

sensor is not

connected





WBC pool over -

temperature








WBC pool low -

temperature








WBC pool temperature

sensor is not

connected





Test motor error 1.Click “Clear” to solve the problem.

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2.Check test motor if problem is not solved. Contact service engineer of

DIRUI if test motor is not available.

Test motor sensor error


2.Check test motor sensor if problem is not solved. Contact service

engineer of DIRUI if test motor sensor is not available.

Waste barrel is full

1. Empty waste barrel or replace it with a new barrel.

2. Check the sensor and mainframe connection.

3. Check the float sensor. Contact service engineer of DIRUI if sensor is not

available.

Sample aspiration

motor error

1. Click “Clear” to solve the problem.

2. Check the motor if failure remains. Contact service engineer of DIRUI if it

is not available.

Sample aspiration

motor sensor error


2. Check the motor sensor if failure remains. Contact service engineer of

DIRUI if it is not available.

Waste buffer bottle is

full Empty waste barrel or replace it with a new barrel.

X axis motor error


2. Check the X axis motor if failure remains. Contact service engineer of


First sensor of X axis

motor error


2. Check the first sensor of X axis motor if failure remains. Contact service

engineer of DIRUI if it is not available.

Second sensor of X

axis motor error


2. Check the second sensor of X axis motor if failure remains. Contact

service engineer of DIRUI if it is not available.

Third sensor of X axis

motor error


2. Check the third sensor of X axis motor if failure remains. Contact service

engineer of DIRUI if it is not available.

Fourth sensor of X axis

motor error


2. Check the fourth sensor of X axis motor if failure remains. Contact

service engineer of DIRUI if it is not available.

X axis motor error


2. Check the X axis motor if failure remains. Contact service engineer of


Y axis motor error


2. Check the Y axis motor if failure remains. Contact service engineer of


133


Appendix A

Network Communication Interface Protocol V1.1

A.1 This protocol is used for information transmission between BF-6500 Automatic Hematology

Analyzer and LIS. It is based on HL7 standard, HL7 version is 2.4.

A.2 Terms

MSH: each MSH head part is used for defining message purpose and aim, each message is

made up by several message segments. The first segment in each MSH is always the message

head segment. It indicates the sending and receiving program name and message type, and

only message ID code, and following segment structure is decided by message type. For

example, a sample message send by OBR segment, one test result information send by many

OBX segment.

Segment: each message segment is made up by several group of date fields, each message

segment has name, and it is used for bounding the content or function. Such as Message

Header (MSH), patient information (PID), case history (PV1)

Field: segment made by several date field. Different date field are separated by list separator.

134


Syntax Format

<SB>dddd <EB><CR>

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

dddd: data(made up by different length bytes). This is the HL7data content. Data could contain

any byte value and ASCII code’s carriage return symbol greater than hex value 0x1F ,<CR>.

<EB>: message end character(1 byte). ASCII character <FS>, namely, `0x1C.

<CR>: carriage return (1 byte). ASCII character<CR>, namely, 0x0D.

Example:

<SB> MSH|^~\&|LIS|1234567890|||20100427194802||ORU^R01|1|P^S|2.4| <CR>

<EB><CR>

There into:

5 character after MSH are list separators used to differentiate each field, discreteness and sub-

discreteness. Although those character could be any non-text character, but HL7 standard

recommend following characters:

Delimiter Value

Field Separator |

Discreteness Separator ^

Sub-Discreteness Separator &

Repeat Separator ~

ESC \

A.3 Message Segment Used in this Protocol

MSH－message head

PID－patient information

PV1－case history

OBR－test report information

OBX－test report test informationEQU –instrument detail

NDS - instrument affiche detail

A.4 HL7 Attribute Table

Message segment in the protocol could be divided into required, optional, and repeatable.

MSH Definition Table.

MSH –message head: this message segment is required item， includes HL7 message basic information, message separator value, message type and message coding method and so on, it

is each HL7 message’s first message segment.

Information Example:

MSH|^~\&|BF-6500|1234567890|||20100419104618||ORU^R01|361|P^S|2.4|||||CHN|

UNICODE<cr>

Serial

NO.Field Name Length

HL7 Advised

Length Explanation Example

1 Field 1 1 Include the first field separator |

135


Separator

after message segment, used for

regulating other message field

separator value

2Coded

Character4 4

Include discreteness separator,

repeat separator, ESC, sub-

discreteness separator

^~\&

3Send

Program7 180

Send terminal apply program

value：BF-6500 BF-6500

4Instrument

Code10 180

Sending terminal instrument,

value: instrument code

123456789

0

7 Send Time 14 26

Message created time （form As

YYYY[MM[DD[HH[MM[SS]]]]]）

， Take system time value

20110310

144704

9Message

Type7 7

Message type, form as

“information type” event type,

value: ORU^R01(Sample)

OUL^R21 （LJ/X、XB QC）

ORU^R01

10Message

Control ID20 20

Message control ID is used for

only mark one message,

value :PID

361

11Transact ID

NO.3 3

This field is used for decide on

whether to transact HL7 operation

program’s(7th layer) transact rule

definition information.

Value: P^ message type（Type

Value：S-sample、LJ-LJ /X

barQC, XB-XB QC）

P^S

12HL7 Version

NO.3 60

Agreements adopt HL7 version

No. Value: 2.42.4

17 Nation Code 3 3Nation code mark, refer to HL 7

2.4CHN

18Character

Set

10

10

ISO/IEC 10646-1-1993

International character standard

value: UTF-8UTF-8

PID：

PID–patient information: this information segment is optional, used for patient sample

transmission, include patient case history number, name, age, gender etc.

Message Example

PID||1234567890||| Wang San Qiang||| M<cr>

136


Serial

NO.

Field

NameLength

HL7

Advice

Length

Explanation Example

2

Case

History

no.

20 20

Patient ID, here used for patient

case history NO. 1234567890

5 Name 50 250 Patient name Wang San Qiang

8 Gender 10 1Gender, showed as character

stringM

PV1 Definition Table

PV1 –patient in hospital information : This message segment is optional, use for patient sample

transmission, include patient department, bed NO., deliver doctor, examiner and so on.

MEssage example:

PV1||| clinic^^235689|||| doctor Wang| Zhang San| Li Si<cr>

Serial

NO.

Field

NameLength

HL7

Advice

Length

Explanation Example

3

Pointed

patient

position

80 80

form as :department^^bed no.

^^clinic 235689

7Deliver

doctor50 250

deliver doctor, character stringdoctor Wang

8 Examiner 50 250 examiner, character string Zhang San

9 Auditor 50 250 auditor, character string Li Si

OBR Definition Table

OBR –testing report list information : This information segment is optional, mainly include test

report information, include sample serial number, and scan No., tube rack No., deliver time and

so on.

Message example :

OBR||23|31C3F010230DFB03|0001^Count

Results||20071207080000|20071207160000|||||| |20071207083000||||2311|

322<cr>

137


Serial

NO.

Field

NameLength

HL7

Advice

Length

Explanation Example

2

Sample

Serial

Number

16 22

Sample number in testing

Document No. in LJ/X QC 23

3 Scan No. 32 22Barcode ID in sample testing

Lot No. in LJ/X QC 31C3F010230DFB03

4

Data

Service

Type

200 200

Service ID symbol, used for sign

on different count result type.

Idiographic value check the

appendix OBR-4 message

coding definition.

0001^Count Results

6Sample

Time14 26

Sampling time in testing.

Validity in LJ/X quality control

7Count

Time14 26

Counting time in sample

information

Count time in LJ/X QC

Count time in X-B quality control

14Delivery

Time14 26

delivery time.

18Tube

Rack NO.2 60

19 Tube NO. 2 60

OBX Definition Table

OBX –Test result: this message segment is repeatable item, mainly include all test result

parameter information and sample test mode, analysis mode and reference group, etc.

Message example

OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00|L|||F<cr>

Serial

NO.

Field

NameLength

HL7

Advice

Length

Explanation Example

1Serial

NO.ID10 10

Used for mark different OBX

message segment1

2 Data Type 3 3Test result’s data type, value is

“ST” 、 “NM” 、 “ED” 、 “IS” etc.ED

3 ID Symbol 250 250 Test item mark. Form as “ID ^

Name”, ID is test item mark, Name

is test item descript information.

Each test item serial no. value

reference as appendix: identify

coding definition. NOTE:ID used

138


for only make one testing

parameter, but name mainly for

descript, not for mark.

5

test result,

chart data,

notes,

quality

control

level……

65536 65536

Test result data, could be number,

character string, enumerate value,

binary system etc, data specific

value reference the enumerate

value table.( Binary data such as

histogram and scatter plot, using

Base64 encoding to do

conversion)

6 Unit 10 250

Unit, note: "^" in unit conflicts with

discreteness separator, so use "*"

to instead

10*9/L

7

Test

Result

Reference

Value

20 60

The scope of the test results,

forms: "the reference range lower

limit - upper limit of reference

range"

12.463-33.569

11

Test

Result

Condition

20 20

Test result condition. Value is “F” -

（Final Result）. Shows final test results

F

This protocol use the custom coding approach.

OBR-4 Code Definition

Code Name Explanation OBR-4 Field

1001 Count Results sample count result 1001^ Count Results

1002 LJ QC LJ QC count result 1002^ LJ QC

1004 XB QC XB QC count result 1004^ XB QC

OBX-3 Identify Coding Definition

Code Name ExplanationValue

TypeOBX-3 Field

2001 MODE test mode IS 2001^MODE

2002 MODE_EX analysis mode IS 2002^MODE_EX

2003 Ref reference IS 2003^Ref

2004 Age age NM 2004^Age

2005 Note note ST 2005^Note

139


2006 Level L-J/X QC level IS 2006^Level

2007 V_WBC total white blood cell NM 2007^V_WBC

2008 V_BAS_cThe number of

basophilsNM

2008^V_BAS_c

2009 V_NEU_cThe number of

neutrophilsNM

2009^V_NEU_c

2010 V_EOS_cThe number of acidic

granulocyteNM

2010^V_EOS_c

2011 V_LYM_cThe number of

lymphocytesNM

2011^V_LYM_c

2012 V_MON_cThe number of

mononuclear cellsNM

2012^V_MON_c

2013 V_BAS_pThe percentage of

basophilsNM

2013^V_BAS_p

2014 V_NEU_pThe percentage of

neutrophilsNM

2014^V_NEU_p

2015 V_EOS_pThe percentage of

eosinophilsNM

2015^V_EOS_p

2016 V_LYM_p Lymphocyte percentage NM 2016^V_LYM_p

2017 V_MON_ppercentage of

MonocytesNM

2017^V_MON_p

2018 V_RBCThe number of red blood

cellsNM

2018^V_RBC

2019 V_HGB Hemoglobin NM 2019^V_HGB

2020 V_MCV MCV NM 2020^V_MCV

2021 V_MCHMean corpuscular

hemoglobinNM

2021^V_MCH

2022 V_MCHC

Mean corpuscular

hemoglobin

concentration

NM

2022^V_MCHC

2023 V_RDW_CV

Coefficient of variation

of red blood cell

distribution width

NM

2023^V_RDW_CV

2024 V_RDW_SD

Standard deviation of

red blood cell

distribution width

NM

2024^V_RDW_SD

2025 V_HCT Hematocrit NM 2025^V_HCT

2026 V_PLT Platelet count NM 2026^V_PLT

2027 V_MPV Mean platelet volume NM 2027^V_MPV

140


2028 V_PDWPlatelet distribution

widthNM

2028^V_PDW

2029 V_PCT Platelet hematocrit NM 2029^V_PCT

2030 V_P_LCRPlatelet - macrophage

ratioNM

2030^V_P_LCR

2101RBC

Histogram.BIN

RBC scattergram BMP

data ED

2101^RBC

Scattergram.BMP

2102PLT

Histogram.BIN

PLT scattergram BMP

dataED

2102^PLT

Scattergram.BMP

2103WBC

Histogram.BIN

WBC scattergram BMP

dataED

2103^WBC

Scattergram.BMP

2034

DIFF

Scattergram.BM

P

DIFF scattergram BMP

data ED

2034^DIFF

Scattergram.BMP

2104

WBCD Scattergram.BMP

WBCD scattergram

BMP data ED

2104^WBCD

Scattergram.BMP

2079 XB_Num How many quality

control in XB to

generate a quality

control

NM 2079^ XB_Num

Enumeration Type

Data Item Value

test mode 0- CBC 1- CBC+DIFF

analysis mode0-open-whole blood 1-open-

pre-dilution 2-auto-whole blood

reference

0- normal

1- M

2- F

3- Child

4- baby

5- custom 1

6- custom 2

7- custom 3

8- custom 4

9- custom 5

L-J/X QC level

0- high

1- medium

2- low

Whole Information Segment Example

141


1． Patient Sample

<SB> MSH|^~\&|BF-6500||||20110310150421||ORU^R01|8|P^S|2.4|||||

CHN|UTF-8 <cr>

PID||1234567890|||Wang Sanqiang|||Male<cr>

PV1|||门诊^^235689||||Doctor Wang|Zhang San|Li Si<cr>

OBR||2|12345|1001^ Count Results||20110310112251|20110310112409|||||| |20110310 112251||||0|0 <cr>OBX|1|IS|2001^MODE||0||||||F<cr>

OBX|2|IS|2002^MODE_EX||1||||||F<cr>

OBX|3|IS|2003^Ref||0||||||F<cr>

OBX|4|IS|2004^Age||17|age|||||F<cr>

OBX|5|ST|2005^Note||note position||||||F<cr>

OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|7|NM|2008^V_BAS_c||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|8|NM|2009^V_NEU_c||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|9|NM|2010^V_EOS_c||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|10|NM|2011^V_LYM_c||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|11|NM|2012^V_MON_c||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|12|NM|2013^V_BAS_p||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|13|NM|2014^V_NEU_p||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|14|NM|2015^V_EOS_p||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|15|NM|2016^V_LYM_p||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|16|NM|2017^V_MON_p||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|17|NM|2018^V_RBC||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|18|NM|2019^V_HGB||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|19|NM|2020^V_MCV||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|20|NM|2021^V_MCH||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|21|NM|2022^V_MCHC||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|22|NM|2023^V_RDW_CV||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|23|NM|2024^V_RDW_SD||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|24|NM|2025^V_HCT||4.63|10*9/L|11.00-12.00|L|||F<cr>

142


OBX|25|NM|2026^V_PLT||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|26|NM|2027^V_MPV||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|27|NM|2028^V_PDW||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|28|NM|2029^V_PCT||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|29|NM|2030^V_P_LCR||4.63|10*9/L|11.00-12.00|L|||F<cr>

OBX|30|ED|2101^RBC Scattergram.BMP||……BMP binary system data change to

BASE64 code……||||||F<cr>

OBX|31|ED|2102^PLT Scattergram.BMP||……BMP binary system data change to


OBX|32|ED|2103^WBC Scattergram.BMP||……BMP binary system data change to


OBX|33|ED|2034^DIFF Scattergram.BMP||……BMP binary system data change to


OBX|34|ED|2104^WBC Scattergram.BMP||……BMP binary system data change to


<EB><CR>

2．L-J/X QC

<SB>MSH|^~\&|BF-6500||||20110311091016||OUL^R21||P^LJ|2.4|||||

CHN|TUF-8<cr>

OBR||2|123 |1002^ LJ QC||20100819 |20110217131356|||||| |||||0|0<cr>OBX|1|IS|2006^Level||0||||||F<cr>

OBX|2|NM|2007^V_WBC||4.63||||||F<cr>

OBX|3|NM|2008^V_BAS_c||4.63||||||F<cr>

OBX|4|NM|2009^V_NEU_c||4.63||||||F<cr>

OBX|5|NM|2010^V_EOS_c||4.63||||||F<cr>

OBX|6|NM|2011^V_LYM_c||4.63||||||F<cr>

OBX|7|NM|2012^V_MON_c||4.63||||||F<cr>

OBX|8|NM|2013^V_BAS_p||4.63||||||F<cr>

143


OBX|9|NM|2014^V_NEU_p||4.63||||||F<cr>

OBX|10|NM|2015^V_EOS_p||4.63||||||F<cr>

OBX|11|NM|2016^V_LYM_p||4.63||||||F<cr>

OBX|12|NM|2017^V_MON_p||4.63||||||F<cr>

OBX|13|NM|2018^V_RBC||4.63||||||F<cr>

OBX|14|NM|2019^V_HGB||4.63||||||F<cr>

OBX|15|NM|2020^V_MCV||4.63||||||F<cr>

OBX|16|NM|2021^V_MCH||4.63||||||F<cr>

OBX|17|NM|2022^V_MCHC||4.63||||||F<cr>

OBX|18|NM|2023^V_RDW_CV||4.63||||||F<cr>

OBX|19|NM|2024^V_RDW_SD||4.63||||||F<cr>

OBX|20|NM|2025^V_HCT||4.63||||||F<cr>

OBX|21|NM|2026^V_PLT||4.63||||||F<cr>

OBX|22|NM|2027^V_MPV||4.63||||||F<cr>

OBX|23|NM|2028^V_PDW||4.63||||||F<cr>

OBX|24|NM|2029^V_PCT||4.63||||||F<cr>

OBX|25|NM|2030^V_P_LCR||4.63||||||F<cr>

OBX|26|ED|2031^RBC Histogram.BIN||……BIN binary system data change to BASE64

code……||||||F<cr>

OBX|27|ED|2032^PLT Histogram. BIN||……BIN binary system data change to BASE64


OBX|28|ED|2034^DIFF Scattergram.BMP||……BMP binary system data change to BASE64


<EB><CR>

3．X-B QC

<SB>MSH|^~\&| BF-6500||||20110311091040||OUL^R21||P^XB|2.4|||||

CHN| UTF-8<cr>

OBR||||1004^ XB QC|||20071207160000||||||||||||<cr>

OBX|1|NM|2079^XB_Num||20||||||F<cr>

OBX|2|NM|2073^m_MCV_R||12.204||||||F<cr>

OBX|3|NM|2074^m_MCH_R||0.258||||||F<cr>

144


OBX|4|NM|2075^m_MCHC_R||12.445||||||F<cr>

OBX|5|NM|2076^m_MCV_L||45.859||||||F<cr>

OBX|6|NM|2077^m_MCH_L||1.258||||||F<cr>

OBX|7|NM|2078^m_MCHC_L||2.36||||||F<cr>

OBX|8|NM|2020^V_MCV||4.63||||||F<cr>

OBX|9|NM|2021^V_MCH||4.63||||||F<cr>

OBX|10|NM|2022^V_MCHC||4.63||||||F<cr>

<EB><CR>

Appendix B

Report Designer User Guide

The report can be modified or created through report designer setting to design the ideal report

145


format. We offer the following two kinds of report template:

·With no graph, paper can be saved

·With graph, the default report format.

In initial use, please save the template before modification. For the design of the template is

debugged strictly, inappropriate changes may affect the printing.

The following describes the specific function and use of the report designer.

B.1 Report Designer Object

Report designer is in the toolbar(left), a total of three objects:

Icon Name Description

TextBox Rectangular box which contain multiple lines of text. Allow

contain variable text.

PictureBox Display picture format of BMP，ICO，WMF，EMF and JPG

Line Draw vertical or horizontal lines in report.

B.1.1 “TextBox”

Rectangular box which contain multiple lines of text. Type, color and width of frame, font

attribute, text alignment and font direction (vertical or horizontal) can be set. Use ”Text” and

”Frame” tools to set the attribute of the object, as figure B.1 shows：

Text box object includes: text, variables, data fields or any combination of these. Font formatting

will be applied to all text included in text object.

·TextBox Modification:

Click on the left of Report Edit Designer, click the left mouse after rectangular icon appears,

as shown in figure B.2:

Figure B.1

146


Clipboard operation；

Word wrap；

Cancel button；

OK button

Note: data included in the database includes patient information, sample test information, the

corresponding set of specific field will be detailed in the following chapter.

B.1.2 “Picture Frame”

Picture can be inserted in the report. The format of the picture is BMP、WMF、ICO.

·Picture frame modification:

Click on the left of Report Edit Designer, click the left mouse after rectangular icon appears,

as shown in figure B.3:

Figure B.2

147


Click “Select..” in figure B.3, and click “OK”, the picture can be inserted into the report.

B.1.3 “Line”

The horizontal or vertical line can be inserted in the report. In separate statement of the report,

straight-line makes it easy to be read. The line thickness and color can be adjusted by using the

drawing toolbar.

Click , drag the mouse in the current page, the cursor will turn into a pencil to draw a straight

line. Click the mouse to begin the line, release it when the line is finished. The line can be

modified.

·Line modification: select the corresponding button in “frame toolbar” to modify the line.

（a） “Standard”toolbar

(b)“Format”toolbar

(c)“Frame”toolbar

（d）“Alignment”toolbar

Figure B.3

148


The use of the button is same as other software.

B.2 Page Options

B.2.1 Paper

Set the page option for the current page of the report, select “File｜Page Setting”in designer

menu, or double click blank area, as figure B.4 shows:

Select the paper size of current printer in the drop down list of paper size.

If the current printing support self-defined paper format, select "Self-defining", and then input the

width and length of the paper format.

Note: not all printer drive or printer support self-defining paper format (e.g. printer drive“HP

LaserJet 6L”does not support 76*127mm size; printer drive“HP LaserJet 4L”does not support all

self-defining size)

B.2.2 Paper Source

Click “Paper Source” in figure B.4, as figure B.5 shows:

Figure B.4

Figure B.5

149


Select the commonly used paper source.

B.2.3 Margins

Click “Margin” in figure B.4, as figure B.6 shows:

If the "Extend to the printer" option is selected, the page form of designer will not display the

border area. All regions of the page will be printed correctly. But the size is different in different

printing.

If this option is canceled, and all margin set to be 0, then the margin will be automatically set to

the selected printer's maximum print area. When designed report switch from one printer to other

printer (the printable area of ink jet printer is smaller than that of stylus printer), this function very

useful.

If the margin set to be non 0, margins will be reflected in a page from of the designer (marked

with gray lines). If you use a dot matrix printer, first preview whether the print content is within the

print area (some stylus printer will not print the content beyond printing scope, and other printer

prompts the beyond print scope). In this case, set the margins manually.

B.2.4 Other

Click “Margin” in figure B.4, as figure B.7 shows:

Figure B.6

150


Set the number of columns and column spacing according to the page width. If the "print to front

page" option is selected, it allows print the remaining area in the new page.

B.3 Users create their own report sheet

The report template we provided, list all data of patient test report and L-J QC report in detail.

Open all selected objects of the report before create report sheet. The report template is in

software installation directory, \ Print \ Sample: is patient sample report template ; \ Print \ QC: is

QC report template.

Concrete action : Open à select report àedit à Select All àNew Reportà Page

SetupàPaste. In this new report, the position, font and the letter of text can be modified.

B.3.1 Title：

Set the sample test report and QC report in "System Setting". For example: × × × hospital, the

title is × × × hospital test report. The “Test Report” can be set hereby. It can be modified into

"Blood test report "," LJ report ", etc. The title can be modified into static text.

B.3.2 Paper：

Users also can modify the size of print paper. If the user use inkjet or laser printer and A4 paper,

set paper A4. If the user use stylus printer (such as: epson 300K, 1600K, etc.), and use 80

column printing paper, set the paper to be self-defining. If a 80 column paper need to print three

reports, set the paper to be 9.34(length). If a 80 paper need to print two reports, set the paper to

be 14, paper width is 22. The default margin is 0.

B.3.3 Select the object need to be modified：

Click the object need to be modified with mouse (points around the selected object will appear),

Figure B.7

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press Shift, more than one objects can be selected. Press Ctrl, and move the mouse meanwhile,

then the mouse moved area will be selected.

· Modify the letter of the static text: select the text need to be modified, and double click the

textbox, input the modified letter in the corresponding box, and press “Enter”.

· Modify the data field: If it is used to display certain data, only one textbox need to be added to

appropriate position, double-click the text box, input the data value, refer to the existing template

for the value.

· Move object: select the object (more than one can be selected), then press the four buttons

around "Move" to move the object, arrow keys on the keyboard can also be used.

· Change size: select the object, press the up and down buttons of "high" or "width" to increase

or decrease the height or width.

· Change the font: Select the object, and then select the font size or bold, italic and so on.

· Undo: error happened during modification, undo operation for one or more times, the report

will return back to the style before modification.

· Save: press the "Save" button after all operation is completed. Note: If it is patient sample

report, please store in the software installation directory \ Print \ Sample folder; save quality

control report into \ Print \ QC folder of software installation directory

· Use: open the system setting in data management software, select the report in print setting.

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Appendix C

Product Warranty

Dear customer:

Thank you for purchasing Automatic Hematology Analyzer of our company. We can

offer you the following service:

1. Technique consultation is provided at any time.

2. One year warranty from the day purchased.

3. Paid service is provided in following condition:

a. Product out of warranty period.

b. Damage caused by accident or wrong operation.

c. Operation is not according to the manual requirement.

d. Repair the instrument without our permission.

4. Upgrading service is provided along with the technique improvement.

For technique support, contact the following address and telephone:

Manufacturer: Changchun Dirui Industrial CO., LTD.

Address: 95, Yunhe Street, New & High Tech. Development Zone, Changchun, China

Sales department telephone: 0431-85100409

After service telephone: 0431-81931012

Complain telephone: 0431-85191787

Fax :0431-85172581

Zip code :130012

Email :[email protected]

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Website: http://www.dirui.com.cn

Europ Authorised Representative

Emergo Europe

Molenstraat 15

2513 BH The Hague

The Netherlands

Appendix D

Product Description

D.1 Product assortment:

According to medical equipment product assortment catalogue:①

Belong to blood analyze system in clinic counting instrument (6840), type II in management type.

According to electric shock protection assortment: type② Ⅰ

D.2 Accessory reagent:

● Diluent

● BF-FDT

● BF-SLS-Ⅰ

● BF-FDO

● Shutdown liquid (Enzyme Detergent)

D.3 Parameter Description

The parameter is obtained from histogram or scattergram.

Name Ab. Unit

Lymphocyte Percentage LYM％％

Monocyte Percentage Mon％％

Neutrophil Percentage Neu％％

Eosinophil Percentage Eos% ％

Basophil Percentage Bas% ％

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http://www.dirui.com.cn/


Mean RBC Volume MCV fL

Variation coefficient of RBC width

distribution

RDW-CV ％

Standard deviation of RBC width

distribution

RDW-SD fL

Mean Platelet Volume MPV fL

Platelet Width Distribution PDW ％

The parameter is obtained from calculation.

Name Ab. Unit

Lymphocyte Number LYM# 109／L

Monocyte Number Mon# 109／L

Neutrophil Number Neu# 109／L

Eosinophil Number Eos# 109／L

Basophil Number Bas# 109／L

RBC Hematocrit HCT L／L

Mean RBC Hemoglobin

Content

MCH pg

Mean RBC Hemoglobin

Concentration

MCHC g／L

Platelet Hematocrit PCT ％

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Statement

Dirui Co., LTD. has the final explanation right.

Dirui Co., LTD.is responsible for the security, reliability and capability of the product under the

following circumstance:

1) Installation, adjustment, improvement and repair are conducted by Dirui company

professionals.

2) Relevant electric equipment is qualified according to state norms.

3) User Manual should be obeyed when operating instrument.

Please call 0431- 81931012 for any question.

The manufacturer reserves the right to make changes without prior notice.

2011/6

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bf-6500 automatic hematology analyzer user manual 1111

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