Instruction

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.
II
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.
III
Content
Chapter 1 Brief Introduction ................................................................................................................................ 1
1.1 Summary ....................................................................................................................................... 1

1.2 Specification .................................................................................................................................. 1
1.3 Working Principle .......................................................................................................................... 3
1.3.1 Sample Aspiration .................................................................................................................. 4
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 ......................................................................................................................... 19
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
IV
3.2.5 Mask ............................................................................................................................... 38

3.2.6 Query ............................................................................................................................. 39
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 ........................................................................................................ 67
4.5.1 Parameter Alarm .................................................................................................................. 68
4.5.2 Differential or Abnormal Form Alarm ................................................................................... 69
4.6 Sleeping ...................................................................................................................................... 70
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 ................................................................................................................................ 73
5.1 Record Selection ......................................................................................................................... 74

5.2 Print ............................................................................................................................................. 75
5.3 Query .......................................................................................................................................... 76
5.3.1 Query Accroding to Sample No. ........................................................................................... 77
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................................................................................................ 78
5.3.5 Query According to Name and Sex ...................................................................................... 78
5.3.6 Query According to Department and Deliver Doctor ............................................................ 78
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 .......................................................................................................................................... 81
5.9 Chart Query................................................................................................................................. 82
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Chapter 6 Quality Control ................................................................................................................................. 83
6.1 L-J QC ......................................................................................................................................... 83

6.1.1 Quality Control Setting ......................................................................................................... 84
6.1.2 QC Counting......................................................................................................................... 88
6.1.3 QC Result Review ................................................................................................................ 89
6.1.4 QC List ................................................................................................................................. 92
6.2 X QC ......................................................................................................................................... 93
6.3 X-B QC ........................................................................................................................................ 93
6.3.1 QC Setting ............................................................................................................................ 94
6.3.2 QC Counting......................................................................................................................... 95
6.3.3 QC Graph Review ................................................................................................................ 95
6.3.4 QC List Review .................................................................................................................... 97
Chapter 7 Calibration ........................................................................................................................................ 99
7.1 Calibration Frequency ................................................................................................................. 99

7.2 Calibration Method ...................................................................................................................... 99
7.2.1 Preparation before Calibration ............................................................................................. 99
7.3 Calibration with Calibrator ......................................................................................................... 100
7.4 Fresh Blood Calibration ............................................................................................................ 102
7.4.1 Fresh Blood Preparation. ................................................................................................... 102
7.4.2 Fresh Blood Calibration ...................................................................................................... 103
7.5 Manual Calibration .................................................................................................................... 105
7.6 Calibration Log .......................................................................................................................... 106
Chapter 8 Service ........................................................................................................................................... 107
8.1 Maintenance Guide ................................................................................................................... 108

8.1.1 Regular Maintenance ......................................................................................................... 108
8.1.2 Maintenance in Need ......................................................................................................... 108
8.2 System Status ........................................................................................................................... 108
8.2.1 System Version .................................................................................................................. 109
8.2.2 Basic Status........................................................................................................................ 110
8.3 Mechanical Detect .................................................................................................................... 111
8.3.1 Motor Detect ....................................................................................................................... 111
8.3.2 Valve Detection .................................................................................................................. 111
8.3.3 Pump Detection .................................................................................................................. 112
8.4 System Maintenance ................................................................................................................ 112
8.4.1 Replacement / Priming ....................................................................................................... 112
8.4.2 Rinsing ............................................................................................................................... 116
8.4.3 Maintenance ....................................................................................................................... 118
8.4.4 Reagent Registration ......................................................................................................... 124
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

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

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 ...................................................................................................................................................... 147
Appendix C ..................................................................................................................................................... 154
Appendix D ..................................................................................................................................................... 155
Statement ........................................................................................................................................................ 158
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 Specification
Sample 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)：
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White Blood Cell WBC
Neutrophil Neu#
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
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Hematocrit HCT
Platelet Number PLT
Mean Platelet Volume MPV
Platelet Distribution Width PDW
Plateletcrit PCT
Larger Platelet Cell Ratio P-LCR
Diff Scattergram
RBC Histogram
PLT Histogram
WBC Histogram
WBC Diff Histogram
Storage: 30000 test results;
L-J/ X 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

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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 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
Whole Blood Sample 6μL
Diluent 3mL
Dilution Ratio 1：500
Aspirate 50μL
Diluent 3mL
RBC/PLT sample with dilution

ratio about 1：30000
Figure 1-3-1 RBC/PLT Dilution Process
b) WBC/Hemoglobin Dilution Process

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Diluent 3mL
BF-SLS Lyse 0.5mL
W B C / Hemoglobin sample with

dilution ratio of about 1:583
Figure 1-3-2 WBC/Hemoglobin Dilution Process
c)WBC Differential Dilution Process
BF-FDO Lyse 1mL
BF-FDT Lyse 0.2mL
WBC sample with dilution ratio

of 1：200
Figure 1-3-3 WBC Differential Dilution Process
1.3.2.2 Pre-dilution Mode

a)RBC/PLT Dilution Process
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Figure 1-3-4 RBC/PLT Dilution Process
b) WBC/Hemoglobin Dilution Process
Figure 1-3-5 WBC/Hemoglobin Dilution Process
c) WBC Differential Dilution Process
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Figure 1-3-6 WBC Differential Dilution Process
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 1-3-7 Flow Cell
Blood cells go through the laser area after twice acceleration. Under the effect of laser beam, the
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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
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cells (Mon #) as well as eosinophils (Eos #) can be obtained. Cell unit is 10 /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
Bas #
Bas %   100%
WBC
●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
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analyzer 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
RBC=n×l012／L
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●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
RBC  MCV
HCT HCT 
10
HGB
MCH 
Mean hemoglobin content RBC
HGB
MCHC   100
Mean hemoglobin concentration HCT
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.
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: 10 12/L). After each counting, RBC
distribution histogram can be obtained in analysis result area of counting interface. RBC
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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
PLT×MP V
PCT=
10000
●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: 10 9/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.
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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 ②Indicator(yellow-failure status indicator, green-running status indicator,
red-power indicator from left to right) ③Sampling Probe ④Sample Aspiration Key
Figure 1-4-1 Front Picture
1.4.2 Rear Picture
①Right Door ②⑥ Fan ③Upper Cover ④Back Cover ⑤Left Door ⑦BF-SLS-I Lyse
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Inlet ⑧BF-FDO Lyse Inlet ⑨BF-FDT Lyse Inlet ⑩BF-PK Diluent Inlet ○
11
Waste Solution Inlet
Figure 1-4-2 Rear Picture
1.4.3 Right Picture
①Net Port(LAN) ②Sensor Port ③Power Supply ④Power 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

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● 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.

18
● Keep the instrument upright in removing and transportation.
● Vibration should be avoided in removing and transportation. It should be used after checking
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 ○

2 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 ○
1)
19
(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.
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:
Wire1
Wire 2
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:
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:
Figure 2-5-3
27
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:
Main Shotcut Status

Menu
Figure 2-5-4
2.5.2 Counting Interface
2.5.2.1 Main Menu

Test：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 Area

28
From left to right: network connection status, LIS system connection status, printing status:
（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 Area

Bottom of the counting interface is the public information area, as figure 2-5-5 shows:
Username Failure Info. X-B Status Info. Area
Sample No. Sample Info. Running Status System Time
Figure 2-5-5
29
（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
32
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 ―.‖).
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.
Figure 3-2-5
―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
―OK‖.
36
（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:
Figure 3-2-8
37
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
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.
38
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 User

Click ‖Setting‖ in main menu, as shown in figure 3-3-1：
Figure 3-3-1
39
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：
Figure 3-3-2
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 3-3-3
40
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:
Figure 3-3-5
Only the password can be modified when the user login as common user. Click ―Modify
41
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:
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.

42
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:
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.
43
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.
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.
44
（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.
Figure 3-3-11
3.3.2.1 User Settings
Click ―User Setting‖ in figure 3-3-11, as figure 3-3-12 shows:
45
Figure 3-3-12
· Add User：
Click ―Add‖ in figure 3-3-12, as figure 3-3-13 shows:
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:
46
Figure 3-3-14
Click ‖Delete‖ in above figure, the following prompt will pop up:
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：
47
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.
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：
48
Select ―Device Setting‖ in figure 3-3-18, as figure 3-3-19 shows:
Figure 3-3-19
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

49
Click―Unit Setting‖ in figure 3-3-20, as figure 3-3-21 shows:
Figure 3-3-21
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

109/L ***.** Default Unit
3
10 /uL ***.**
WBC 2
10 /uL ****.*
/nL ***.**
9
10 /L ***.** Default Unit
LYM#、MON#、BAS#、EOS#、
% **.* Default Unit
LYM%、MON%、BAS%、EOS%、
NEU#
1012/L **.** Default Unit
NEU%
106/uL **.**
RBC
104/ uL ****
/pL **.**
g/L *** Default Unit
HGB g/dL **.*
mmol/L **.*
fL ***.* Default Unit
MCV、RDW-SD 3
um ***.*
pg **.* Default Unit
MCH
fmol ***
50
g/L *** Default Unit

MCHC g/dL ***.*
mmol/L ***.*
RDW-CV % **.* Default Unit
% **.*
HCT
L/L *.*** Default Unit
9
10 /L **** Default Unit
103/uL ****
PLT 4
10 /uL ***.*
/nL ****
fL **.* Default Unit
MPV 3
um ***.*
PDW fL **.* Default Unit
% .*** Default Unit
PCT
mL/L *.**
P-LCR % **.* Default Unit
Table 3-1
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:
51
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.
Click ―Default Value‖ to restore the setting when the reference has been modified accidentally.
―Default value setting succeed‖ indicates successful setting.
52
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
Select ―Backup Setting‖ in figure 3-3-30, as figure 3-3-31 shows:

56
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：
Preparation before Operation
Power On
Daily QC
Sample Preparation
Sample Analysis
Shutdown
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.
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
Ensure all the diluent(180uL)is added into the tube. Move the tube after the buzzer sound has
61
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.
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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:
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：
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The maximum digit of sample No. is 15. All number should not be ―0‖, otherwise, the software
prompts invalid input.

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 Patient

Sample 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 "
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4.4.3 Sample Testing Steps
Note：
● There should be a space between probe tip and test tube bottom in the process of sample
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):
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.
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（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.
（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:
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Figure 4-4-4
Histogram of RBC, PLT and WBC; histogram and scattergram of WBC 4 diff will be displayed.
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

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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
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.
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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 WBC scattergram abnormal DIFF channel scattergram abnormal
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
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

In shift left position of scattergram,
Left Shift ？ Left shift may be existing.
more scatter dots exits.
The proportion of immature cell is
Immature Cell？ Immature cell exists.
bigger than the set reference value.
Abnormal lymph or non-typical lymph
Abnormal Lymphocyte Lymphocyte abnormity exists.
is bigger than the set reference value
Nucleated red blood cell Maybe RBC hemolysis is not
/ platelet aggregation complete, red blood cell is on The scatter dots are condensed
immature stage or platelet between lymphocyte and ghost cell.
aggregation
(c)RBC/HGB abnormal alarm information

Abnormal RBC Abnormal RBC histogram Abnormal RBC histogram
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distribution distribution
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 RBC or hemoglobin may be Compare the result of hemoglobin
inaccurate. with RBC result
unreliable？
Hemoglobin Abnormal hemoglobin maybe Calculate and compare the special

abnormity/interference exists, or interference factor analytical parameters.
maybe exists.
？
(e)PLT unreliable alarm information
PLT increase PLT increase PLT>600*109/L
PLT reduction PLT reduction PLT<60*109/L

PLT distribution PLT histogram distribution PLT histogram abnormity
abnormity abnormity
(f) PLT unreliable alarm information

PLT aggregation maybe Calculate and compare the special
PLT aggregation？
exists. analytical parameters.
Table 4-1
4.6 Sleeping
The analyzer enters into sleeping status after stop for 30 minutes, and the status information will
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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.
Shutdown includes mainframe shutdown and exit software.
4.8.1 Shutdown Mainframe
Click " " in main interface. As shown in figure 4-8-1：
Figure 4-8-1
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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
·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.
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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

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:
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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:
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:
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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:
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
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―Condition‖ in its drop-down list , as shown in figure 5-3-1.
Figure 5-3-1
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:
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Figure 5-3-2
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.
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
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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:
Figure 5-4-1
Click the No. in front of record(√), and click CV, as figure 5-4-2 shows:
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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:
Figure 5-5-1
Select the test date in the drop down list of ―Test Date‖, and input the start sample No. and end
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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:
Figure 5-7-1
Click ―OK‖ in above figure to delete the records.
5.8 Export
The exported data can be saved.
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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:
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:
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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.
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, X 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
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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.
Figure 6-1-1
6.1.1 Quality Control Setting
6.1.1.1 Lot No. Information Setting

QC information can be set through setting button.
Click set, as shown in figure 6-1-2.
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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：
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
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counting.
6.1.1.2 Preset Value

The 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:
Figure 6-1-3
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 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
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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.
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
counting.The sampling probe will aspirate 20ul Control automatically to conduct QC counting.
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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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Figure 6-1-10
(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：
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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
(a) Delete All：The operator can delete all QC results of current QC document.
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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 X 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
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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‖.
（b）Click ―QC‖ in above menu, and select ―X-B‖ in , as figure 6-3-2 shows:
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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
6-3-3.
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Figure 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

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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.
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Note:
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.
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· 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.
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.
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Figure 7-3-2
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.
Figure 7-3-3
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
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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 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.
Figure 7-3-5
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.
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7.4.2 Fresh Blood Calibration
Note: Fresh blood calibration need to be conducted under ―Whole Blood‖ and ―Pre-dilution‖
testing mode.
Click ―Fresh Blood Calib‖ in figure 7-3-1 to enter fresh blood calibration interface, as shown in
figure 7-4-1.
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.
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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, 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.
Figure 7-4-3
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:
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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.
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.
Figure 7-4-5
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.
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Figure 7-5-1
（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 7-6-1
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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.
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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
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in this interface.
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:
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.

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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 also
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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.
Figure 8-4-2
Click OK，pop up progress bar as shown in Figure 8-4-3：
Figure 8-4-3
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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.
（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：
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Click Prime FDO when FDO Lyse being emptied. The following box will pop up:
Figure 8-4-5
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
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.
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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:
Figure 8-4-8
(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.
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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.
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:
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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
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.
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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 8-4-13
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
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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
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:
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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:
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:
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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.
(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:
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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:
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
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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:
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:
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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.
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:
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Sample
Pump
Figure 8-5-1
① ④
② ⑤
③
Figure 8-5-2
①SLS Syringe Pump ②FDO Syringe Pump ③FDT Syringe Pump ④Diluent Pump
⑤Test Pump
8.6 System Log
Click ―Log‖ in main interface, and select ―Error Log‖ in its drop-down list , as
figure 8-6-1 shows:
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Figure 8-6-1
The operator can also select ―Operation Log‖ and ―Failure Log‖ in its drop-down list for checking.
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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:
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‖.
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10.2 Failure Information and Solution
Alarm Information Solution

1.Check the diluent.
2. Replace a new bottle of diluent if there is no diluent. Click ―Clear‖ to prime
Diluent bottle is empty.
diluent.
3.Check the float switch if diluent is sufficient. Replace it if it is not usable.
HGB background 1.Please check whether the diluent has been polluted.
exceeds range. 2.Click ―Clear‖ to solve it if the diluent is not polluted.
5V voltage exceeds 1.Click ―Clear‖ to solve it.
range. 2.Replace the circuit board if problem can not be solved.
WBC aperture voltage 1.Click ―Clear‖ to solve it.
exceeds range. 2.Replace the circuit board if problem can not be solved.
55V voltage exceeds 1.Click ―Clear‖ to solve it.
RBC aperture voltage 1.Click ―Clear‖ to solve it.
exceeds range. 2.Replace the circuit board if problem can not be solved.
Laser current exceeds 1.Click ―Clear‖ to solve it.
1.Check the FDO.
FDO empty 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.
1.Click ―Clear‖ to solve the problem.
Lyse motor error 2.Check lyse motor if problem is not solved. Contact service engineer of
DIRUI if lyse motor is not available.
Lyse motor sensor error 2.Check lyse motor sensor if problem is not solved. Contact service
engineerof DIRUI if lyse motor sensor is not available.
1.Check the diluent.
2.Replace a new bottle of diluent if there is no diluent. Click ―Clear‖ to prime
Dilluent buffer bottle diluent.
empty 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.
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
Voltage error
DIRUI if air pump is not available.
4.Contact engineer to adjust the voltage regulating valve if this problem
remains.
Y axis motor sensor
2.Check Y axis motor sensor if problem is not solved. Contact service
error
engineer of DIRUI if Y axix motor sensor is not available.
Diluent motor error 1.Click ―Clear‖ to solve the problem.
131
2.Check diluent motor if problem is not solved. Contact service engineer of

DIRUI if diluent motor is not available.
Diluent motor sensor
2.Check diluent motor sensor if problem is not solved. Contact service
error
engineer of DIRUI if diluent motor sensor is not available.
1.Check the SLS.
SLS empty 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
2.Check data collection board if problem is not solved. Contact service
verification error
engineer of DIRUI if data collection board is not available.
Data collection board is 2.Check the connection of data collection board.
not connected 3.Check whether the board is damaged if failure remain exists. Contact
service engineer of DIRUI if board is damaged.
2.Check whether the heater is damaged if failure remain exists. Contact
service engineer of DIRUI if heater is damaged.
Laser over-temperature 3.Check whether the thermistor is damaged if failure remain exists. Contact
service engineer of DIRUI if thermistor is damaged.
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 3.Check whether the thermistor is damaged if failure remain exists. Contact
Laser temperature 2.Check the connection of temperature sensor.
sensor is not connected 3.Check whether the sensor is damaged if failure remain exists. Contact
service engineer of DIRUI if sensor is damaged.
Room over- 2. Please make sure the ambient temperature is within normal range [15，
temperature
30]℃.
3.Replace the temperature sensor if failure remains.
2. Please make sure the ambient temperature is within normal range [15，
Room low-temperature
30]℃.
3.Replace the temperature sensor if failure remains.

Room temperature 1.Click ―Clear‖ to solve the problem.
132
sensor is not connected 2.Check the connection of temperature sensor.

3.Check whether the sensor is damaged if failure remain exists. Contact
WBC pool over
3.Check whether the thermistor is damaged if failure remain exists. Contact
-temperature
WBC pool low
3.Check whether the thermistor is damaged if failure remain exists. Contact
-temperature
WBC pool temperature 2.Check the connection of temperature sensor.
sensor is not connected 3.Check whether the sensor is damaged if failure remain exists. Contact
Test motor error 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.
1. Empty waste barrel or replace it with a new barrel.
2. Check the sensor and mainframe connection.
Waste barrel is full
3. Check the float sensor. Contact service engineer of DIRUI if sensor is not
available.
1. Click ―Clear‖ to solve the problem.
Sample aspiration
2. Check the motor if failure remains. Contact service engineer of DIRUI if it
motor error
is not available.
Sample aspiration
2. Check the motor sensor if failure remains. Contact service engineer of
motor sensor error
DIRUI if it is not available.
Waste buffer bottle is
Empty waste barrel or replace it with a new barrel.
full
X axis motor error 2. Check the X axis motor if failure remains. Contact service engineer of
First sensor of X axis
2. Check the first sensor of X axis motor if failure remains. Contact service
motor error
engineer of DIRUI if it is not available.
133

Second sensor of X
2. Check the second sensor of X axis motor if failure remains. Contact
axis motor error
service engineer of DIRUI if it is not available.
Third sensor of X axis
2. Check the third sensor of X axis motor if failure remains. Contact service
motor error
Fourth sensor of X axis
2. Check the fourth sensor of X axis motor if failure remains. Contact service
motor error
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
134
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.
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

135
MSH－message head
PID－patient information
PV1－case history
OBR－test report information
OBX－test report test information
EQU –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 HL7 Advised
Field Name Length Explanation Example
NO. Length
Include the first field separator
Field after message segment, used for
1 1 1 |
Separator regulating other message field
separator value
Include discreteness separator,
Coded
2 4 4 repeat separator, ESC, ^~\&
Character
sub-discreteness separator
Send terminal apply program
Send
3 7 180 BF-6500
Program value：BF-6500
Instrument Sending terminal instrument, 123456789

4 10 180
Code value: instrument code 0
Message created time （form

20110310
As
7 Send Time 14 26
YYYY[MM[DD[HH[MM[SS]]]]]）， 144704
Take system time value

Message Message type, form as
9 7 7 ORU^R01
Type ―information type‖ event type,
136
value: ORU^R01(Sample)
OUL^R21 （LJ/X、XB QC）
Message control ID is used for

Message
10 20 20 only mark one message, 361
Control ID
value :PID
This field is used for decide on
whether to transact HL7 operation
program‘s(7th layer) transact rule
definition information.
Transact ID
11 3 3 Value: P^ message type（Type P^S
NO.
Value：S-sample、LJ-LJ /X barQC,
XB-XB QC）
HL7 Version Agreements adopt HL7 version

12 3 60 2.4
NO. No. Value: 2.4
Nation code mark, refer to HL 7
17 Nation Code 3 3 CHN
2.4
10 ISO/IEC 10646-1-1993
Character International character standard
18 10 UTF-8
Set
value: UTF-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>

HL7
Serial Field
Length Advice Explanation Example
NO. Name
Length
Case Patient ID, here used for patient
2 History 20 20 case history NO. 1234567890
no.
5 Name 50 250 Patient name Wang San Qiang
Gender, showed as character
8 Gender 10 1 M
string
137
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>
HL7
Serial Field
NO. Name
Length
Pointed form as :department^^bed no.
3 patient 80 80 ^^clinic 235689
position
Deliver deliver doctor, character string
7 50 250 doctor Wang
doctor
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>
HL7
Serial Field
NO. Name
Length
Sample Sample number in testing
2 Serial 16 22 Document No. in LJ/X QC 23
Number
Barcode ID in sample testing
3 Scan No. 32 22 31C3F010230DFB03
Lot No. in LJ/X QC
Data Service ID symbol, used for sign
4 Service 200 200 on different count result type. 0001^Count Results
Type Idiographic value check the
138
appendix OBR-4 message

coding definition.
Sample Sampling time in testing.
6 14 26
Time Validity in LJ/X quality control
Counting time in sample
Count information
7 14 26
Time Count time in LJ/X QC
Count time in X-B quality control
Delivery delivery time.
14 14 26
Time
Tube
18 2 60
Rack NO.
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>
HL7
Serial Field
NO. Name
Length
Serial Used for mark different OBX
1 10 10 1
NO.ID message segment
Test result‘s data type, value is
2 Data Type 3 3 ED
―ST‖ 、 ―NM‖ 、 ―ED‖ 、 ―IS‖ etc.
Test item mark. Form as ―ID ^

Name‖, ID is test item mark, Name
is test item descript information.
Each test item serial no. value
3 ID Symbol 250 250 reference as appendix: identify
coding definition. NOTE:ID used
for only make one testing
parameter, but name mainly for
descript, not for mark.
Test result data, could be number,
test result,
character string, enumerate value,
chart data,
binary system etc, data specific
notes,
5 65536 65536 value reference the enumerate
quality
value table.( Binary data such as
control
histogram and scatter plot, using
level……
Base64 encoding to do
139
conversion)
Unit, note: "^" in unit conflicts with

6 Unit 10 250 discreteness separator, so use "*" 10*9/L
to instead
Test The scope of the test results,
Result forms: "the reference range lower
7 20 60 12.463-33.569
Reference limit - upper limit of reference
Value range"
Test result condition. Value is ―F‖ -
Test
11 Result 20 20 （Final Result）. Shows final test F
Condition
results
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 Explanation Value Type OBX-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
2006 Level L-J/X QC level IS 2006^Level
2007 V_WBC total white blood cell NM 2007^V_WBC
2008 V_BAS_c The number of basophils NM 2008^V_BAS_c
The number of 2009^V_NEU_c

2009 V_NEU_c NM
neutrophils
The number of acidic 2010^V_EOS_c
2010 V_EOS_c NM
granulocyte
140
The number of 2011^V_LYM_c

2011 V_LYM_c NM
lymphocytes
The number of 2012^V_MON_c
2012 V_MON_c NM
mononuclear cells
The percentage of 2013^V_BAS_p
2013 V_BAS_p NM
basophils
The percentage of 2014^V_NEU_p
2014 V_NEU_p NM
neutrophils
The percentage of 2015^V_EOS_p
2015 V_EOS_p NM
eosinophils
2016 V_LYM_p Lymphocyte percentage NM 2016^V_LYM_p
percentage of 2017^V_MON_p
2017 V_MON_p NM
Monocytes
The number of red blood 2018^V_RBC
2018 V_RBC NM
cells
2019 V_HGB Hemoglobin NM 2019^V_HGB
2020 V_MCV MCV NM 2020^V_MCV
Mean corpuscular 2021^V_MCH

2021 V_MCH NM
hemoglobin
Mean corpuscular 2022^V_MCHC
2022 V_MCHC hemoglobin NM
concentration
Coefficient of variation of 2023^V_RDW_CV
2023 V_RDW_CV red blood cell NM
distribution width
Standard deviation of 2024^V_RDW_SD
2024 V_RDW_SD red blood cell NM
distribution width
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
Platelet distribution 2028^V_PDW

2028 V_PDW NM
width
2029 V_PCT Platelet hematocrit NM 2029^V_PCT
Platelet - macrophage 2030^V_P_LCR

2030 V_P_LCR NM
ratio
RBC RBC scattergram BMP 2101^RBC
2101 ED
Histogram.BIN data Scattergram.BMP
PLT PLT scattergram BMP 2102^PLT
2102 ED
141
WBC WBC scattergram BMP 2103^WBC

2103 ED
DIFF DIFF scattergram BMP 2034^DIFF
2034 Scattergram.BM data ED Scattergram.BMP
P
WBCD WBCD scattergram 2104^WBCD
2104 Scattergram.B BMP data ED Scattergram.BMP
MP
2079 XB_Num How many quality NM 2079^ XB_Num
control in XB to generate
a quality control
Enumeration Type
Data Item Value
0- CBC 1-
test mode
CBC+DIFF
0-open-whole blood 1-open-
analysis mode
pre-dilution 2-auto-whole blood
0- normal
1- M
2- F
3- Child
4- baby
reference
5- custom 1
6- custom 2
7- custom 3
8- custom 4
9- custom 5
0- high
L-J/X QC level 1- medium
2- low
Whole Information Segment Example
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||||||
142
|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>
143
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>
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
>
144
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>
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>
145
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>
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>
146
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
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
147
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：
Figure B.1
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.2
Clipboard operation；
Word wrap；
148
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.3
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
149
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
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:
Figure B.4
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.

150
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.5
Select the commonly used paper source.
B.2.3 Margins
Click ―Margin‖ in figure B.4, as figure B.6 shows:
Figure B.6
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
151
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.7
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  select report edit  Select All New Report Page SetupPaste.
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.
152
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),
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.
153
· 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.
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.

154
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 :dirui@dirui.com.cn
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:
①According to medical equipment product assortment catalogue:
Belong to blood analyze system in clinic counting instrument (6840), type II in management type.
②According to electric shock protection assortment: typeⅠ

155
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% ％
Mean RBC Volume MCV fL
Variation coefficient of RBC width RDW-CV ％

distribution
Standard deviation of RBC width RDW-SD fL
distribution
Mean Platelet Volume MPV fL
Platelet Width Distribution PDW ％
The parameter is obtained from calculation.
Name Ab. Unit
Lymphocyte Number LYM# 109／L
156
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 MCH pg
Content
Mean RBC Hemoglobin MCHC g／L

Concentration
Platelet Hematocrit PCT ％
157
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
158

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BF-6500 Automatic Hematology Analyzer User Manual

can not be used.

●The instrument must be used in good grounding condition.

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

component may be damaged and personal security is endangered.

assistant whom are specially trained.

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

software installation may affect the normal working of the instrument.

and shape change.

for at least 24 hours before power on.

of water and seek medical advice if needed.

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.

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

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

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

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

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

3.2.5 Mask ............................................................................................................................... 38

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

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

Chapter 5 Record Query ................................................................................................................................ 73

5.1 Record Selection ......................................................................................................................... 74

Chapter 6 Quality Control ................................................................................................................................. 83

6.1 L-J QC ......................................................................................................................................... 83

Chapter 7 Calibration ........................................................................................................................................ 99

7.1 Calibration Frequency ................................................................................................................. 99

Chapter 8 Service ........................................................................................................................................... 107

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

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

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

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

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

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

Appendix B ...................................................................................................................................................... 147

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

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

Statement ........................................................................................................................................................ 158

Chapter 1 Brief Introduction

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

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

account the clinical test result or other test result.

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

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

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

Laser Tube Wavelength: 540nm

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

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

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

Test Item(including research parameters)：

White Blood Cell WBC

Intermediate Cell Mon#

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%