BF-6500 User Manual 2016-01

This manual is applicable for BF Series Automatic Hematology Analyzer (Model: BF-6500),
hereinafter called “instrument”.
Instruction
Dear user, thanks for choosing our BF Series Automatic Hematology Analyzer (Model: BF-6500).
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.
Date of Manufacture: refer to the label.
Use Limit: 7 years.
Version: REV.01-2016.
Configuration No.: 001.
Warning
● An independent power supply is a must. Electromagnetism interference will affect the accuracy of the test
result.
● Do not pull the electrical wire with wet hand, or there is a risk of electrical shock.
● Do not trample, twist, drag the wire and cable, or it may cause fire. The damaged wire and cable cannot 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 cannot be used in flammable and explosive environment.
● Do not touch moving parts when the instrument is testing to avoid accident.
● Non-professionals cannot 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.
● The protective measure may not be effective if the instrument is not operated according to the user manual.
Note
● Instrument should be operated by medical inspection specialist, physician, nurse or lab assistant who are
specially trained.
● Maintenance plan is needed for hospitals and inspection organizations. And the plan should be followed
strictly. Otherwise, instrument failure may occur.
● Instrument should be controlled by special software specified by the manufacturer. Other hardware or
software installation may affect the normal working of the instrument.
● Expired reagent cannot 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 cannot be used for outside cleaning, it may cause color and shape change.
●When the transportation or storage temperature in winter is low or the relative humidity is more than 75%,
the instrument should be kept in the normal work environment for at least 24 hours before power on.
Biohazard
● Please dispose of the reagent, waste solution, waste samples and consumables according to the national or
local regulations.
● Please dispose of the waste solution and instrument consumables according to the regulations of medical
waste, infective waste and industrial waste. Blood in the waste may have been contaminated by pathogens.
●Blood samples, Control and Calibrator on the sampling probe may have potential bio-infectivity. Avoid
contact with the sampling probe. When aspirating a sample, there should be a certain distance between the
probe tip and the wall of the container to avoid blood splash. Otherwise the accuracy of aspiration volume may
be affected.
● Avoid direct contact with the patient's blood.
● Disposable supplies cannot be reused.
Statement
The manufacturer has the final interpretation of the manual.
The manufacturer is responsible for the security, reliability and performance of the instrument after the
following requirements are met:
(1)Installation, debugging and repair are conducted by professionals from the manufacturer.
(2)Relevant electrical equipment is in line with the national standards.
(3)Operation is subject to the user manual.
All software interfaces are subject to change without notice.

User Manual
Content
Chapter1 Brief Introduction .....................................................................................................1-1

1.1 Overview .................................................................................................................................................... 1-1
1.2 Working Environment .............................................................................................................................. 1-1
1.3 Specification ............................................................................................................................................... 1-1
1.4 Working Principle ..................................................................................................................................... 1-2
1.4.1 Sample Aspiration ....................................................................................................................................................... 1-2
1.4.2 Sample Dilution .......................................................................................................................................................... 1-2
1.4.3 WBC Testing .............................................................................................................................................................. 1-5
1.4.4 WBC Parameter .......................................................................................................................................................... 1-6
1.4.5 Hemoglobin Concentration Testing— Colorimetry .................................................................................................... 1-7
1.4.6 RBC / PLT Testing...................................................................................................................................................... 1-7
1.4.7 Rinsing ........................................................................................................................................................................ 1-9
1.5 Instrument Structure ................................................................................................................................ 1-9

1.5.1 Front Picture.............................................................................................................................................................. 1-10
1.5.2 Rear Picture ............................................................................................................................................................... 1-10
1.5.3 Right Picture ............................................................................................................................................................. 1-11
1.6 External Devices ...................................................................................................................................... 1-11

1.7 Symbol ...................................................................................................................................................... 1-12
Chapter2 Installation .................................................................................................................2-1
2.1 Installation Requirement .......................................................................................................................... 2-1
2.1.1 Space Requirement...................................................................................................................................................... 2-1
2.1.2 Power Requirement ..................................................................................................................................................... 2-1
2.1.3 Environmental Requirement ....................................................................................................................................... 2-1
2.2 Unpacking .................................................................................................................................................. 2-2

2.2.1 Unpacking Procedures ................................................................................................................................................ 2-2
2.2.2 Transportation Method ................................................................................................................................................ 2-2
2.3 Installation Steps ....................................................................................................................................... 2-2

2.3.1 Hardware Installation .................................................................................................................................................. 2-2
2.3.2 Software Installation ................................................................................................................................................... 2-4
2.4 Software Uninstallation .......................................................................................................................... 2-12

2.5 Software Login ........................................................................................................................................ 2-12
2.5.1 Login Software .......................................................................................................................................................... 2-12
2.5.2 Counting Interface..................................................................................................................................................... 2-15
2.5.3 Log Off ..................................................................................................................................................................... 2-17
2.5.4 Log Out ..................................................................................................................................................................... 2-17
Chapter3 Instrument Setting ....................................................................................................3-1
3.1 Sample Information .................................................................................................................................. 3-1
3.2 Data Browse ............................................................................................................................................... 3-1
3.2.1 Edit Patient Information .............................................................................................................................................. 3-2
3.3 Setting ......................................................................................................................................................... 3-5

3.3.1 Normal User ................................................................................................................................................................ 3-5
3.3.2 Administrator User .................................................................................................................................................... 3-11
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Chapter4 Calibration .................................................................................................................4-1

4.1 Calibration Frequency .............................................................................................................................. 4-1
4.2 Calibration Method ................................................................................................................................... 4-1
4.2.1 Preparation before Calibration .................................................................................................................................... 4-1
4.3 Calibration with Calibrator ..................................................................................................................... 4-1

4.4 Fresh Blood Calibration ........................................................................................................................... 4-3
4.4.1 Fresh Blood Preparation .............................................................................................................................................. 4-3
4.4.2 Fresh Blood Calibration .............................................................................................................................................. 4-3
4.5 Manual Calibration ................................................................................................................................... 4-5

4.6 Calibration History ................................................................................................................................... 4-5
Chapter5 Quality Control .........................................................................................................5-1
5.1 L-J QC ........................................................................................................................................................ 5-1
5.1.1 Quality Control Setting ............................................................................................................................................... 5-1
5.1.2 QC Counting ............................................................................................................................................................... 5-4
5.1.3 QC Result Review ....................................................................................................................................................... 5-6
5.1.4 QC List ........................................................................................................................................................................ 5-8
5.2 X QC ........................................................................................................................................................ 5-8

5.3 X-B QC ....................................................................................................................................................... 5-9
5.3.1 QC Setting ................................................................................................................................................................... 5-9
5.3.2 QC Counting ............................................................................................................................................................. 5-10
5.3.3 QC Graph Review ..................................................................................................................................................... 5-10
5.3.4 QC List Review ......................................................................................................................................................... 5-11
Chapter6 Normal Operation .....................................................................................................6-1
6.1 Preparation before Operation .................................................................................................................. 6-1
6.2 Daily QC ..................................................................................................................................................... 6-1
6.3 Sample Preparation................................................................................................................................... 6-1
6.3.1 Whole Blood Sample Preparation ............................................................................................................................... 6-1
6.3.2 Add Diluent ................................................................................................................................................................. 6-2
6.4 Sample Testing of Whole Blood Mode .................................................................................................... 6-3

6.4.1 Changing Test Mode and Sample No. ......................................................................................................................... 6-3
6.4.2 Sample Information Editing ........................................................................................................................................ 6-4
6.4.3 Sample Testing Steps .................................................................................................................................................. 6-5
6.4.4 Picture Check .............................................................................................................................................................. 6-6
6.4.5 Research Parameter Check .......................................................................................................................................... 6-7
6.5 Pre-dilution Sample Testing ..................................................................................................................... 6-8

6.5.1 Parameter Alarm ......................................................................................................................................................... 6-8
6.5.2 Differential or Abnormal Form Alarm ........................................................................................................................ 6-8
6.6 Sleeping .................................................................................................................................................... 6-10

6.7 Rinse and Clog Removal ......................................................................................................................... 6-10
6.8 Shutdown ................................................................................................................................................. 6-10
6.8.1 Shutdown Mainframe ................................................................................................................................................ 6-10
6.8.2 Exit Software............................................................................................................................................................. 6-11
Chapter7 Record Query ............................................................................................................7-1
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7.1 Record Selection ........................................................................................................................................ 7-1

7.2 Print ............................................................................................................................................................ 7-2
7.3 Query .......................................................................................................................................................... 7-3
7.3.1 Query Accroding to Sample No. ................................................................................................................................. 7-4
7.3.2 Query According to ID Number .................................................................................................................................. 7-4
7.3.3 Query According to Test Mode and Date .................................................................................................................... 7-4
7.3.4 Query According to Case No. ..................................................................................................................................... 7-4
7.3.5 Query According to Name and Sex ............................................................................................................................. 7-4
7.3.6 Query According to Department and Deliver Doctor .................................................................................................. 7-4
7.3.7 Query According to Auditor ....................................................................................................................................... 7-4
7.3.8 Query According to Checker....................................................................................................................................... 7-4
7.4 CV Calculation and Tendency Graph ..................................................................................................... 7-5

7.4.1 CV Calculation............................................................................................................................................................ 7-5
7.4.2 Tendency Graph .......................................................................................................................................................... 7-5
7.5 Bulk Audit .................................................................................................................................................. 7-7

7.6 Communication ......................................................................................................................................... 7-7
7.6.1 Sample Application ..................................................................................................................................................... 7-8
7.7 Delete .......................................................................................................................................................... 7-8

7.8 Export ......................................................................................................................................................... 7-8
7.9 Sample Adding .......................................................................................................................................... 7-9
7.10 Patient information modification ........................................................................................................... 7-9
7.11 Recheck .................................................................................................................................................... 7-9
7.12 Chart Query ........................................................................................................................................... 7-10
7.13 Review Compare ................................................................................................................................... 7-10
7.13.1 Parameter Setting .................................................................................................................................................... 7-11
7.13.2 Comparison List ...................................................................................................................................................... 7-12
7.13.3 Tendency ................................................................................................................................................................. 7-12
7.14 Backup .................................................................................................................................................... 7-13

7.15 Restore .................................................................................................................................................... 7-14
7.16 Help......................................................................................................................................................... 7-15
Chapter8 Service ........................................................................................................................8-1
8.1 Maintenance Guide ................................................................................................................................... 8-1
8.1.1 Regular Maintenance .................................................................................................................................................. 8-1
8.1.2 Maintenance in Need................................................................................................................................................... 8-1
8.2 System Status ............................................................................................................................................. 8-2

8.2.1 System Version ........................................................................................................................................................... 8-2
8.2.2 Basic Status ................................................................................................................................................................. 8-3
8.3 Mechanical Detect ..................................................................................................................................... 8-4

8.3.1 Motor Detect ............................................................................................................................................................... 8-4
8.3.2 Valve Detection........................................................................................................................................................... 8-4
8.3.3 Pump Detection ........................................................................................................................................................... 8-4
8.4 System Maintenance ................................................................................................................................. 8-4

8.4.1 Replacement / Priming ................................................................................................................................................ 8-4
8.4.2 Rinsing ........................................................................................................................................................................ 8-7
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8.4.3 Maintenance ................................................................................................................................................................ 8-9

8.4.4 Reagent Registration ................................................................................................................................................. 8-13
8.5 Replacement of Wearing Components .................................................................................................. 8-15

8.5.1 Replace Syringe Pump .............................................................................................................................................. 8-15
8.6 System Log ............................................................................................................................................... 8-16

Chapter9 Failure Handling .......................................................................................................9-1
9.1 Overview .................................................................................................................................................... 9-1
9.2 Failure Information and Solution ............................................................................................................ 9-2
Chapter10 Transportation and Storage .................................................................................10-1
10.1 Transportation....................................................................................................................................... 10-1
10.2 Storage .................................................................................................................................................... 10-1
AppendixA Network Communication Interface Protocol V1.1 ............................................ A-1
AppendixB Report Designer User Guide ................................................................................ B-1
AppendixC Product Warranty ................................................................................................ C-1
AppendixD Product Description .............................................................................................. D-1
AppendixE Performance Index................................................................................................ E-1
AppendixF Accessories List...................................................................................................... F-1
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User Manual
Chapter1 Brief Introduction
1.1 Overview
BF Series Automatic Hematology Analyzer (Model: BF-6500) 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. Instrument is connected with computer to conduct
operations.
The scope of the product: BF Series Automatic Hematology Analyzer is an in vitro diagnostic medical
instrument used by professionals for screening. It is used for testing red blood cell (RBC), platelet (PLT),
white blood cell (WBC) number and volume distribution and concentration of hemoglobin, and it offers
scattergram of white blood cell to help clinical diagnosis.
1.2 Working Environment

(1)Power Supply: 100V-240V~, 50/60Hz;
(2)Environment Temperature: 18℃-30℃;
(3)Relative Humidity: ≤75%;
(4)Atmospheric Pressure: 75kPa ~ 106kPa;
(5)Altitude: ≤2000m;
(6)It should be protected from frost, condensation, water, rain, direct sunlight, etc.
1.3 Specification
Model
Specifications
BF-6500
WBC, BAS#, NEU#, EOS#, LYM#, MON#, BAS%, NEU%, EOS%, LYM%,
Test Item MON%, RBC, HGB, MCV, MCH, MCHC, RDW-CV, RDW-SD, HCT, PLT,
MPV, PDW, PCT, P-LCR
Carry out five-part differential to WBC counting result; the instrument can test 24
Parameters parameter, offer 1 scattergram and 4 histogram; it will alarm when the abnormal
Basic condition of pathology and morphology occurs
Features
Sample injection
Manual sample injection
method
Stored sample volume The maximum test result of stored sample is 30000
Sample barcode Identify automatically or input manually
Reagent type Four types in total, including a diluent and 3 types of lyse
Hemoglobin test Test hemoglobin utilizing the reagent without cyanide

Reagent
System
Reagent alarm It will alarm when there is no reagent or the reagent expires.
Reagent barcode External barcode reader or manual input
WBC classification Cell chemical staining technology, sheath flow technology, optical analysis
Analysis principle method
System
Counting method Utilize impedance technology for WBC counting
Computer
Computer and printer (optional)
configuration
Data
System Interface RJ45 network interface
Connect to LIS/HIS It can connect to LIS/HIS
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User Manual
Model
Specifications
BF-6500
Weight 46kg
Whole 490 mm×540 mm×550mm

instrument Dimensions
system (L×W×H)
Power consumption 175VA
1.4 Working Principle

This instrument adopts electric impedance to test RBC, WBC/ Basophil, PLT number and volume distribution.
Test the hemoglobin concentration by using colorimetry. Adopting semiconductor laser flow cytometry to
obtain WBC 4-differential counting result. The results of other parameters are calculated upon the above
results.
1.4.1 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 20μL peripheral blood with 180μL diluent to form a sample with
dilution ratio of 1:10, and then send it to the instrument for aspiration. The instrument will aspirate 80
μL(CBC+DIFF mode)or 40μL(CBC mode)diluted sample.
1.4.2 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 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 samples, the instrument offers two different working modes - whole blood mode and pre-dilution
(Peripheral Blood) mode.
1.4.2.1 Whole Blood Mode
(1)RBC/PLT Dilution Process
Figure 1-4-1 RBC/PLT Dilution Process
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(2)WBC/Hemoglobin Dilution Process
Figure 1-4-2 WBC/Hemoglobin Dilution Process

(3)WBC Differential Dilution Process
Figure 1-4-3 WBC Differential Dilution Process

1.4.2.2 Pre-dilution Mode
(1)RBC/PLT Dilution Process
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Figure 1-4-4 RBC/PLT Dilution Process

(2)WBC/Hemoglobin Dilution Process
Figure 1-4-5 WBC/Hemoglobin Dilution Process
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(3)WBC Differential Dilution Process
Figure 1-4-6 WBC Differential Dilution Process

1.4.3 WBC Testing
1.4.3.1 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 1-4-7:
Figure 1-4-7 Flow Cell

Blood cells go through the laser area after twice acceleration. Under the effect of laser beam, the scattered light
is related to cell size, refractive index of cell membrane and cell internal structure. Low-angle forward
scattered light reflects the size of cell. High-angle forward scattered light reflects the internal fine structure and
particulate matter. Photodiode receive the scattered light signals and translate them into electrical pulses,
according to the electrical pulses, two-dimension map (scattergram) of cell size and cell internal information
can be obtained. The abscissa reflects the cell's internal structure. The vertical axis reflects the cell size, as
shown in Figure 1-4-8:
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Figure 1-4-8 4-diff Scattergram Drawing

The lymphocytes, monocytes, eosinophils and eutrophils percentage can be obtained from the DIFF channel
scattergram.
1.4.3.2 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 exists 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.
Figure 1-4-9 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.
1.4.4 WBC Parameter
Through analyzing Diff channel scattergram, LYM area, NEU area, MON area and EOS area, the percentage
of lymphocytes (LYM%), the percentage of neutrophils (NEU%), the percentage of mononuclear cells
(MON%), as well as the percentage of eosinophils (EOS%) can be obtained. Calculate by using the WBC
number, lymphocytes (LYM #), neutrophils (NEU #), mononuclear cells (MON #) as well as eosinophils (EOS
#) can be obtained. Cell unit is 109/L.
(1)WBC
WBC number can be obtained through testing the corresponding pulse number (WBC).
(2)Basophil
Basophil number can be obtained through testing the corresponding pulse number (BAS#).
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(3)Basophil Percentage
BAS #
BAS% = ´100%
WBC
(4)Lymphocyte Percentage
The number of cells Lym area of DIFF channel
LYM% = ´100%
The number of all cells in DIFF channel except ghost
(5)Neutrophil Percentage
The number of cells Neu area of DIFF channel
NEU% = ´100%
The number of all cells in DIFFchannel except ghost
(6)Monocyte Percentage
The number of cells Mon area of DIFF channel
MON% = ´100%
(7)Eosinophil Percentage
The number of cells Eos area of DIFF channel
EOS% = ´100%
(8)Lymphocytes
LYM # = WBC´ LYM%
(9)Neutrophil
NEU # = W BC ´ NEU %
(10)Monocyte
M ON # = W BC ´ M ON %
(11)Eosinophil
EOS # = WBC ´ EOS%
1.4.5 Hemoglobin Concentration Testing— Colorimetry

SLS-hemoglobin method is the method combining cationic surfactant and hemoglobin. It is characterized by
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.
Background transmission light intensity
HGB = Cons tan t ´ Log10（）
Sample transmission light intensity
This testing and calculation process will be finished by the instrument automatically, and the result will be
displayed in the counting interface.
1.4.6 RBC / PLT Testing
1.4.6.1 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 exists 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.
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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.
1.4.6.2 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.
1.4.6.3 RBC Parameter
(1)RBC Number
RBC number is obtained through testing corresponding electrical pulse.
Unit: 1012/L
RBC=n×l012/L
(2)Mean RBC Size
Calculate mean RBC size according to RBC distribution histogram. Unit: fL
(3)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
(4)RBC Distribution Width Variation Coefficient
RDW-CV is obtained through RBC distribution histogram. The volume distribution variation coefficient is in
the form of percentage.
(5)RBC Distribution Width Standard Deviation
RDW-SD is histogram width relative to RBC distribution histogram peak (20%), unit fl, as shown in Figure
1-4-10.
Figure 1-4-10
(6)RBC Distribution Histogram
The RBC volume distribution histogram is offered when the result is obtained. The graph that can indicate the
distribution of cell population is RBC distribution histogram. Histogram abscissa is RBC size (unit: fl), vertical
axis is RBC relative number (unit: 1012/L). After each counting, RBC distribution histogram can be obtained in
analysis result area of counting interface. RBC distribution histogram can also be obtained through entering
search interface.
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1.4.6.4 PLT Parameter

(1)PLT Number(PLT)
PLT number is obtained through testing corresponding electrical pulse number, unit 109/L.
PLT=n×l09/L
(2)Mean PLT Volume (MPV)
Calculate mean PLT volume according to PLT distribution histogram. Unit: fL
(3)PLT Distribution Width (PDW)
PDW is obtained through PLT distribution histogram, which is geometric deviation limit of PLT volume
(10GSD).
(4)PCT
Calculate PCT according to the following formula, unit %; PLT unit 109/L unit; MPV unit fl.
PLT´MPV
PCT =
10000
(5)Big PLT Ratio (P-LCR)
(6)Big PLT Ratio is obtained through PLT histogram.
(7)PLT Distribution Histogram.
The PLT volume distribution histogram is offered when the result is obtained. The graph that can indicate the
distribution of cell population is PLT distribution histogram. Histogram abscissa is PLT volume (unit: fl),
vertical axis is PLT relative number (unit: 109/L). After each counting, PLT distribution histogram can be
obtained in analysis result area of counting interface. PLT distribution histogram can also be obtained through
entering search interface.
1.4.7 Rinsing
The instrument rinse itself automatically in each counting process, to ensure no residual sample exists.
(1)Internal and external wall of sampling probe should be rinsed with diluent;
(2)Counting pool should be rinsed with diluent;
(3)Flow cell should be rinsed with diluent.
1.5 Instrument Structure

The instrument is composed of mechanical motion, pipeline, optical, electronic control, software, etc.
The appearance is as follows:
Mechanical motion system: it mainly contains automatic sample injection unit and automatic sample aspiration
unit;
Pipeline system: it mainly contains liquid running pipeline, syringe unit and pump unit;
Optical system: it mainly contains laser shaping, light split and receiving unit;
Electronic control system: it contains main board, drive board and monitoring and control unit;
Software system: it contains embedded software and upper machine software.
The functional interface of front, rear and right of the instrument are as follows:
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1.5.1 Front Picture
1 Front Door 2 Indicator(yellow-failure status indicator, green-running status indicator, red-power indicator from left to right)
3 Sampling Probe 4 Sample Aspiration Key
Figure 1-5-1 Front Picture
1.5.2 Rear Picture
1 Right Door 2 Fan 3 Upper Cover 4 Back Cover 5 Left Door

7 Detergent Inlet 8 SLS-I Lyse Inlet 9 FDO Lyse Inlet 10 FDT Lyse Inlet
11 Diluent Inlet 12 Waste Liquid Inlet
Figure 1-5-2 Rear Picture
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1.5.3 Right Picture
1 Internet Access (RJ45) 2 Float Sensor Port 3 Power Supply 4 Power Switch
Figure 1-5-3
1.6 External Devices

Printer: Connect with computer. The report can be printed through computer.
Barcode Reader: Connect with host computer to input barcode information.
The printer is optional.
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1.7 Symbol
Table 1-7-1
Symbol Meaning
BIOLOGICAL RISKS
LASER, DANGER SYMBOL
ALTERNATING CURRENT
IN VITRO DIAGNOSTIC MEDICAL DEVICE
BATCH CODE
USE BY
SERIAL NUMBER
DATE OF MANUFACTURE
PROTECTIVE GROUND
MANUFACTURER
THE DEVICE MEETS THE REQUIREMENTS OF DIRECTIVE ON

IN VITRO DIAGNOSTIC MEDICAL DEVICES
AUTHORISED REPRESENTATIVE IN THE EUROPEAN

COMMUNITY
The symbol of the crossed out wheeled bin indicates that the product
(electrical and electronic equipment) should not be placed in municipal
waste. Please check local regulations for disposal of electronic
products.
CAUTION, REFER TO THE ACCOMPANYING FILES OR MARK
DETAILED WARNING OR MATTERS NEEDING ATTENTION
CATALOGUE NUMBER
“ON”(POWER)
“OFF”(POWER)
The above symbol information is included on the instrument, reagent strips, and Control.
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Chapter2 Installation
To ensure the normal working of the instrument after installation, the initial installation and set-up of the
instrument should be carried out by authorized personnel of the manufacturer.
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. The operating table should bear at least 46kg.
2.1.1 Space Requirement
Ensure enough space for instrument maintenance.
(1)The space between the wall and the right & left side of the instrument ≥50cm;
(2)The space between the wall and the back side of the instrument≥50cm;
(3)The space between the front of the instrument and other equipment ≥ 100cm;
(4)Ensure enough space under and above the instrument for diluent, reagent and waste solution collecting
devices.
Do not install the instrument at the place where is far away from the disconnection device.
2.1.2 Power Requirement
(1)Power Supply: 100V-240V~ 50/60Hz.
(2)Power Consumption: 175VA.
(3)Fuse: F4AL250V 5mm×20mm.
(4)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
(1)Environment Temperature: 18℃-30℃.
(2)Relative Humidity: ≤75%.
(3)Atmospheric Pressure: 75kPa-106kPa.
(4)The instrument should be protected from dust, mechanical vibration, significant noise and power
interference.
(5)It is recommended that the electromagnetic environment assessment of the laboratory should be conducted
prior to test.
(6)Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may
interfere with the proper working.
(7)It should be placed far from the constant ON-OFF electrical devices like brush-type motor, fluorescent
lamp.
(8)It should be placed far from heat and wind source, sunlight, brush-type motor, flickering fluorescent light
and electrical contact equipment.
(9)A well-ventilated place is a must; if necessary, a ventilation device can be used. Direct blowing should be
avoided; otherwise this may affect the test accuracy.
The result will be unreliable if the room temperature or power cannot meet the requirement. Or cause
instrument damage and endanger personal safety.
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2.2 Unpacking
2.2.1 Unpacking Procedures
Upon arrival of the Analyzer, please check the package for intactness. In case of any physical damage, please
contact the manufacturer or local agents. Please unpack the case by following the steps below if no physical
damage is found:
(1)Keep the package case upright and ensure that the arrow is upward.
(2)Unpack the case and take out the accessory case and then check them with packing list to see whether any
component is missing or not. If any component is missing, please contact the manufacturer or local agents
2.2.2 Transportation Method
(1)Remove the reagent bottle and waste tank at the back of the analyzer prior to transportation.
(2)Ensure that the used Analyzer has gone through “Empty Pipeline” before transportation.
(3)Utility cart and the like are available for smooth and short-distance transportation.
(4)When moving and transporting, prevent the display on the front panel and the sampling probe from being
applied with external force, contacting other goods and damaging.
(5)When moving and transporting, always keep the Analyzer upright. Inclination and side laying are not
allowed.
(6)During transportation, avoid vibration as far as possible. After transport, examine and debug the Analyzer
before usage.
2.3 Installation Steps
The instrument should not be disassembled except normal maintenance.

2.3.1 Hardware Installation
1 Detergent Inlet 2 SLS-I Lyse Inlet 3 FDO Lyse Inlet

4 FDT Lyse Inlet 5 Diluent Inlet 6 Waste Liquid Inlet
Figure 2-3-1 Rear Picture
(1)Lyse, Diluent, Waste liquid Connection
Put the FDT Lyse, FDO Lyse, SLS-I Lyse and Detergent bottle at the back of the instrument. Connect
according to Figure 2-3-1.
Diluent bottle andwaste liquid bottle should be put under the working table. Connect according to Figure
2-3-1.
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(2)Liquid Level Sensor Connecting

Connect one end to 2 in Figure 1-5-3. Put the other end into the waste barrel, reagent bottle and Diluents
according to the mark on the lead.
● Waste liquid should be disposed of according to relevant local medical waste treatment regulations.
● The water discharge system should conform to the waste water discharge requirements for local
medical institutions.
(3)Computer Connecting
Connect “Net Port” of computer host with “Net Port” of right side instrument (1 of Figure 1-5-3).
(4)Power Wire Connecting
Connect one end of supplied power line with the attaching plug on the back side of the instrument (3 of Figure
1-5-3). And connect the power line of host, display and printer.
● The socket connected with the power cable should be well-grounded.

● The power socket should be placed near the analyzer for an easy cut-off.
(5)Barcode Reader Connecting
Insert one end of the bar code reader into the “USB” of the computer host.
The light beam of the barcode reader may hurt eyes, therefore, staring should be avoided.
(6)Printer Connecting
Connect the printer and the computer host through data wire.
a)Whether the printer driver is installed.
b)Check the printing paper specification.
Screws will be used for fixing sampling probe before delivery. Screws should be removed before power
on; otherwise, probe may be damaged, as figure shows:
Spacer
Screw 1, 2
Figure 2-3-2
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Screw 3
Figure 2-3-3
After installation, screw 1, screw 2 and spacer of Figure 2-3-2, screw 3 of 2-3-3 should be moved; otherwise,
the probe might be damaged after power on.
2.3.2 Software Installation
The software has been installed by the manufacturer’s professionals before delivery. User should not uninstall
it except abnormity occurs. In case of a must-uninstall, please follow the following steps:
2.3.2.1 Operating Part
The software system is installed on the computer to constitute the operating part of the instrument. The
operating part consists of the host, 21.5 inch display, keyboard, mouse and printer.
Host: 32 bit English Windows 7 operating system, upper computer software environment installation package,
and upper computer software are installed.
Basic configuration: CPU clock speed≥2.8GHz, hard disk drive≥250G, memory≥2G, network interface (two
are better), and USB interfaces.
Display: Display each window, curve, and test data of the instrument software. Resolution≥1366×768.
Keyboard: Perform the instrument operation control and data input.
Mouse: Perform software operation.
Printer: Print test data and diagrams.
2.3.2.2 Computer Setting
(1)IP Setting
Click【Start】→【Control Panel】→【Network and Sharing Center】, select 【Change Adapter Settings】 from
the guide column on the left, open 【Local Connection】, select 【Properties】, and double-click 【Internet
Protocol Version 4(TCP/IPv4)】, as the following figure shows:
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Figure 2-3-4
“XXX” in IP address “172.16.100.XXX” includes but not limited to the number as the above figure shows.
Any number within 【1—255】 except 138 can be input.
The instrument IP address is 172.16.100.138.

(2) Computer Sleep Time Setting
Click 【Start】→【Control Panel】→【Hardware and Sound】→【Power Options】, select 【Change when
the computer sleeps】 from the left guide column, and select 【Never】 from the 【Put the computer to sleep】
pull-down menu, as the following figure shows:
Figure 2-3-5
2.3.2.3 Software Installation

Start “Set DoNet” after putting the software CD in the CD driver of the computer. “.NET Framework4.0”
installation assembly will pop up, as Figure 2-3-6 shows:
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Figure 2-3-6
Click “Install” in the above figure, and the following figure will pop up:
Figure 2-3-7
Click “OK” in the above figure, after restart the Microsoft SQL Server 2005 can AutoRun Installation, as
Figure 2-3-8 shows:
Figure 2-3-8
Click “Next” in the following pages until the page – Figure 2-3-9 shows:
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Figure 2-3-9
Continue to click “Next” until the installation completes. After install SQL2005, it will auto-run the
installation of VC++2008, as Figure 2-3-10 shows:
Figure 2-3-10
VC++ installation completes, as Figure 2-3-11 shows:
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Figure 2-3-11
At last, appearing the following tip illustrates the PC system environment is installed successfully. Then you
can install the upper computer software, as Figure 2-3-12 shows:
Figure 2-3-12
When the above installation has been finished, run upper computer installation program, the installation
interface will pop up, as Figure 2-3-13 shows:
Figure 2-3-13
Click “Next” in above figure, select the installation path, the default path is C:\Program Files\(It is suggested
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that the program should not be installed in C:\, it can be installed in other disks.), meanwhile, all the users have
the permission to install the program by default. As Figure 2-3-14 shows:
Figure 2-3-14
Click “Next” in above figure, the confirm interface will pop up, as Figure 2-3-15 shows:
Figure 2-3-15
Click “Next” in the above figure, the process bar will pop up, as Figure 2-3-16 shows:
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Figure 2-3-16
Click “Next” after installation has been finished, Figure 2-3-17will pop up:
Figure 2-3-17
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.
If the upper computer is installed in the C:\, it is needed to modify the properties of the installation directory
after the upper computer installation steps complete. If the upper computer is installed in the other disks, the
properties do not need to be modified. Details are shown as follows:
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Figure 2-3-18
Click “Security” button on the above figure, as following Figure 2-3-19 shows:
Figure 2-3-19
Click 【Edit…】button on above figure, as following Figure 2-3-20 shows:
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Figure 2-3-20
Click 【Users】 key on above figure, and add security control permissions, that is to say, sign “ ” in
“Permissions for Users” line of “Full control”, then click【Apply】,【OK】 key to save setting.
2.4 Software Uninstallation

If the instrument application software needs to be deleted from the current computer, click “Start” window,
find “Automatic Hematology Analyzer” in “Program”, click “Uninstall Automatic Hematology Analyzer”, the
confirm window will pop up, as Figure 2-4-1 shows:
Figure 2-4-1
Click “Yes” to finish the uninstallation.
2.5 Software Login
Turn on the power switch of the instrument, login the application software.
2.5.1 Login Software
Double click the application software icon , or click “Start”, find the software in “Program” window,
enter into “System Login” window, as Figure 2-5-1, 2-5-2 shows:
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Figure 2-5-1
Figure 2-5-2
Input username, password, the initial user name is Admin (cannot 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
Input username, password in Figure 2-5-2, and click “ ”. to enter the “Component Maintenance”
interface as shown in figure 2-5-4.
Figure 2-5-4
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In the initial login, the checkbox “Automatically turn off after 3 seconds” in the “Component
Maintenance” screen is selected as default, you can cancel selection as required; If cancel, you need to
manually close the window. These operation will take effect when next logon.
When the “Component Maintenance” interface was closed, the screen will display “System self-testing…”.
Then the instrument starts to check the flow path, temperature and background as the figures shown below:
Figure 2-5-5
Figure 2-5-6
● Background test is testing the interference upon particle and electricity.

● If the value of the first time background test exceeds the preset value, the second time background test
will be conducted. If tests are conducted for three times and background results exceed range, system
will prompt “Blank Error”.
● The high value, low value or abnormal result alarm will not be prompted by the instrument.
Click in Figure 2-5-6 after self-test to enter into main interface, as Figure 2-5-7 shows:
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Main Menu Shortcut Status
Figure 2-5-7
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 instrument.
Setting: Set the instrument parameters.
Service: Test the status, maintain and detect the Instrument.
Log: Keep the operation records.
Help: check component maintenance window information.
2.5.2.2 Status Indication Area
From left to right: network connection status, LIS system connection status, printing status:
(1)Network Connection Status:
: Indicates the network is connected, operations are accessible.
: Indicates the network is disconnected.

(2)LIS System Connection Status:
: Indicates LIS is connected, communication operation is accessible.
: Indicates LIS is disconnected.
: Indicates LIS is transmitting.

(3)Printer Status:
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: Indicates the printer is connected, printing is accessible.
: 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 2-5-8 shows:
Username Failure Info. X-B Status Info. Area
Auto rinse Sample No. Sample Info. Test System Time
Figure 2-5-8
(1)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 2-5-9 shows:
Figure 2-5-9
Click the corresponding information, the detailed solution will be displayed in “Detail Information”
(2)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.
(3)Test Status: Indicates the test status.
(4)Sample Information: 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 modes.【CBC】and【CBC+DIFF】.
(5)Rinse Times: 3 in 3/200 indicating the tested sample number from the last time rinsing. 200 represents the
rinsing interval (set in Setting-Automatic Rinsing Setting).
The manual rinsing method is as follow:
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Click , as Figure 2-5-10 shows:
Figure 2-5-10
Click in the above figure, and the status bar displays “Rinsing instrument”. When carrying out
the automatic rinse, the main menu is shown as Figure 2-5-11. Only “Log” can be viewed. In the shortcut key
area, only “Data Browse” and “Data List” can be used. The user can edit patient information and view test
results.
Figure 2-5-11
2.5.3 Log Off
Click in Figure 2-5-7.

2.5.4 Log Out
Click in Figure 2-5-7 to enter “Exit System” window, as Figure 2-5-12 shows:
Figure 2-5-12
Click in above figure to exit. Click to return to interface.
● 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.
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Chapter3 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
Click in Figure 2-5-7, as Figure 3-1-1 shows:
Figure 3-1-1
Analysis Mode: There are two modes. Whole blood mode and pre-diluted (peripheral blood) mode.
Sample No.: What entered here is the number of the next analytic sample.
● Sample No. with “-” is accessible. “.” is NOT accessible (“Sample No. Error” will be prompted if there
is “.”).
● The entered number of the sample to be tested cannot repeat the one of the already-tested or -edited
sample. Otherwise, the new record will replace the former one.
Reference Range: Click the drop down list of “Reference”, general, man, woman, child, infant and
user-defined can be selected.
Test Mode: There are two modes.【CBC】conduct counting without diff upon WBC, counting result includes
histogram and its parameter of WBC, RBC and PLT.【CBC+DIFF】conduct counting and differential upon
WBC, includes 24 parameters and scattergram, histogram.
3.2 Data Browse
Click of main interface shortcut and the following figure pops up:
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Figure 3-2-1
If the lock button is in the locked status, patient information can be edited or modified.
If the lock button is in the locked status, click it to make it unlocked.

3.2.1 Edit Patient Information
Click in Figure 3-2-1to set the input items of patient information, displays as Figure 3-2-2:
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 editing other information.
Ignore: If , this item will be skipped during patient information input.

Click “Disable Setting ”, it turns to “Enable Setting”, when the setting is disabled, click “Add” in the data
browse interface, the added user information will not display in accordance with the settings, when the setting
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is enabled, click “Add” in the data browse interface, the added user information will display in accordance
with the settings.
Click 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
(1)Sample No.: Set the next sample No. manually.
(2)Barcode No.: Can be input manually or by scanning.
(3)Sample Time, Deliver Time: Select “Present Time” or “Blank” from the “Sample Time” and “Deliver
Time” pull-down menu in Figure 3-2-1. If “Present Time” is selected and the corresponding time is clicked,
time can be manually input for the setting.
(4)Reference: Double click the input box behind “Reference” in Figure 3-2-1; the following box will pop up:
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
.The reference range of test items includes general, man, woman, child, newborn and 5 user
define.
3.2.1.2 Patient Information
(1)Case No.: Input the case No. in Figure 3-2-1.
(2)Name: Input the patient name directly.
(3)Sex: Double click the input box behind “Sex” in Figure 3-2-1; the following box will pop up:
Figure 3-2-4
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.
(4)Age: Input the patient age and double click the input box of age unit, the following box will
pop up.
Figure 3-2-5
corresponding item (“Setting” of main menu→ “Information” to set the commonly used ID). Then click
.
The reference value cooperates with age and sex. After selecting sex, inputting age and selecting age unit, the
reference value will be adjusted automatically. Infant≤28 days, 28 days＜child≤13 years old, 13 years old＜
general. If the input age is more than 13 and sex is male, the reference value is male by default, if the input age
is more than 13 and sex is female, the reference value is female by default.
There should be no “.” in age.

(5)Department: Input the department name in department box, double click “Department” input box, the
following box will pop up:
Figure 3-2-6
corresponding item (“Setting” of main menu→ “Information” to set the commonly used ID). Click
.
(6)Bed No.: Click the input box of “Bed No.” in Figure 3-2-1 or input it directly.
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(7)Deliver: Input it directly or double click the input box of “Deliver”, the following figure will pop up:
Figure 3-2-7
.
(8)Remark: the remark information after test can be input(can be input directly).
Press enter to save the information when all the information has been finished.
3.3 Setting
3.3.1 Normal User
Click “Setting” in main menu, as shown in Figure 3-3-1:
Figure 3-3-1
3.3.1.1 Date Format Setting

There are three date formats:
YYYY-MM-DD, MM-DD-YYYY, DD-MM-YYYY, select one of them and press , the following
information will be displayed:
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Figure 3-3-2
Press to save the changed date format. Press to exit the interface.
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 Setting” in Figure 3-3-1, as Figure 3-3-3 shows:
Figure 3-3-3
Click the drop-down menu behind “Select Language”, select the language, click , the tip “Saving
Succeed” will pop up, click to finish the language setting.
3.3.1.3 User Setting
Click “User Setting” in Figure 3-3-3, as Figure 3-3-4 shows:
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Figure 3-3-4
Only the password can be modified when the user login as common user. Click in Figure
3-3-4, as Figure 3-3-5 shows:
Figure 3-3-5
Input the new password and old password (the two passwords must be same), click to finish the
modification.
User edition, addition and deletion cannot be conducted when the user login as common user.
3.3.1.4 Reagent Validity Setting
Single click “Reagent Validity Setting” in Figure 3-3-4, as Figure 3-3-6 shows:
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Figure 3-3-6
Click the drop down box of corresponding item, select the validity according to the reagent instruction, press
, the tip “Saving Succeed” will pop up, click to finish the setting. Click
to exit the interface.
● Detergent and cleanser refer to the same reagent.

● The validity should be set again in the first time instrument using or after reagent, diluent
replacement. Expired reagent, diluent cannot be used.
3.3.1.5 QC Setting
Click “QC Setting” in Figure 3-3-6, as Figure 3-3-7, 3-3-8 shows:
Figure 3-3-7
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Figure 3-3-8
Control method, calculation method and range of L-J/X-bar QC can be selected in Figure 3-3-7.
ON/OFF and sample No./group of X-B QC can be set in Figure 3-3-8.
3.3.1.6 Print Setting
Click “Print Setting” in Figure 3-3-8. Printer name, header icon, title of sample and QC , and report type can
be set in Figure 3-3-9.
Figure 3-3-9
(1)Printer: Select the printer in its drop-down list.
(2)Report Default Icon: Report pageheader icon can be set. Click , the dialog box of picture
path will pop up. Select the picture(picture size is 34*34, format can be BMP or JPG).
Click to clear the pageheader icon. The icon will not be displayed in report preview.
(3)Sample: Headline, pagefooter and print report format can be input in this unit.
a)Headline: Delete the original headline and input new headline if headline need to be changed.
b)Page Footer: The page footer is user-defined, e.g. “This report is only responsible for the delivered
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sample.”
c)Print Report Type: Select the type in its drop-down list. Click to preview the format.
(4)QC: The headline and print report format can be input in this unit.
a)Headline: Delete the original headline and input new headline to change it.
b)Print Report Type: Select the print type in its drop-down menu, and click to preview the
format.
(5)Report Designer: User can design report type.
Refer to “Appendix B” for its using.
(6)Print clogged aperture mark: in case that “Print clogged aperture mark” is ticked, if the report data is with
clogged aperture, there is the clogged aperture mark (?) on the printed report; in case that it is not ticked, if the
report data is with clogged aperture, there is no the clogged aperture mark (?) on the printed report.
(7)Print Research Parameter: when “Print Research Parameter” is ticked, “Input microscopic examination
result” will display in the interface, as following figure shows:
Figure 3-3-10
3.3.1.7 Clogged aperture re-test switch

Click “Clogged aperture re-test switch” in Figure 3-3-9, as Figure 3-3-11 shows:
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Figure 3-3-11
Select “ON” or “OFF”, then click “Save”.
Selecting “ON”, in the process of test, the aperture is clogged, the instrument will re-test automatically.
Selecting “OFF”, in the process of test, the aperture is clogged, the instrument will alarm, “Aperture is clogged,
perform clog removal or rinsing aperture”.
3.3.1.8 Automatic sleep time
Click “Automatic sleep time” in Figure 3-3-9, the automatic sleep time of the instrument can be set, the range
is [10, 120], as Figure 3-3-12 shows:
Figure 3-3-12
3.3.2 Administrator User

Input administrator username and password when login (Figure2-5-2), click “Setting”, as Figure 3-3-13 shows,
the administrator can set the following items besides common user’s:
Admin is system default administrator username. Default password is 1. The password can be modified,
but cannot be deleted.
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Figure 3-3-13
3.3.2.1 User Setting

Click “User Setting” in Figure 3-3-13, as Figure 3-3-14 shows:
Figure 3-3-14
(1)Add User:
Click in Figure 3-3-14, as Figure 3-3-15 shows:
Figure 3-3-15
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Input the username needing to be added in the input box behind “Username”. Click to , which is in front of
“Audit Permission” if the user needs audit permission, To entitle “Admin Permissions” to added user, click
radio box before “Admin Permissions”(like this “ ”, and entitle “Audit Permissions” to added user
meanwhile), and click to finish the user adding.
Click after username input if this user does not need audit permission or administrator.
● The initial password of the new user is “1”, which can be modified after login.
● The name of new user cannot be empty or same as other username.
(2)Delete User:
Click the line of common user in Figure 3-3-14, the selected line will turn into blue, the interface is like
3-3-16:
Figure 3-3-16
Click in above figure, the following prompt will pop up:
Figure 3-3-17
Click , the selected user will be deleted.

(3)Edit User:
Click the line of common user in Figure 3-3-16, click , the interface is like 3-3-18:
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Figure 3-3-18
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. Click the radio box again to cancel the permission.
User’s admin permission can be reset. To entitle admin permission to user, select radio box before【Admin
Permission】. To delete user’s audit permission, cancel radio box before【Admin Permission】. This user will
become general user.
(4)Modify Password:
The password of the administrator and common user can be modified by administrator.
Click the line needs to be modified in Figure 3-3-16, click , the interface is like 3-3-19:
Figure 3-3-19
Input old password, new password, press to finish the operation.

3.3.2.2 Network Setting
Click “Network Setting” in Figure 3-3-16, and select “Device Setting” in the display link, as Figure 3-3-20
shows:
Figure 3-3-20
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The IP of the instruments cannot be modified by the user.

LIS Setting:
Select “LIS Setting” in Figure 3-3-20, as Figure 3-3-21 shows:
Figure 3-3-21
IP and port of LIS computer can be set. ON/OFF status of “Auto-communication” can be selected. ON/OFF
status of “Translate data after clog” can be selected.
3.3.2.3 Unit Setting
Click “Unit Setting” in Figure 3-3-21, as Figure 3-3-22 shows:
Figure 3-3-22
Single click the input box behind items and select the units. Click after input. Click
when “Saving Succeed” is prompted. Click “Default Value” to restore the setting when the unit
has been modified accidentally. “Default value setting succeeded” indicates successful setting.
The units are as follow:
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Table 3-1-1
Parameter Unit Value Form Remark

109/L ***.** Default Unit
103/μL ***.**
WBC
2
10 /μL ****.*
/nL ***.**
9
LYM#, MON#, BAS#, EOS#, NEU# 10 /L ***.** Default Unit
LYM%, MON%, BAS%, EOS%, NEU% % **.* Default Unit
1012/L **.** Default Unit

6
10 /μL **.**
RBC
104/ μL ****
/pL **.**
g/L *** Default Unit
HGB g/dL **.*
mmol/L **.*
fL ***.* Default Unit

MCV, RDW-SD
3
μm ***.*
pg **.* Default Unit

MCH
fmol ***
g/L *** Default Unit
MCHC g/dL ***.*
mmol/L ***.*
RDW-CV % **.* Default Unit
% **.*
HCT
L/L *.*** Default Unit
109/L **** Default Unit

3
10 /μL ****
PLT
104/μL ***.*
/nL ****
fL **.* Default Unit

MPV
μm3 ***.*
PDW fL **.* Default Unit
% .*** Default Unit

PCT
mL/L *.**
P-LCR % **.* Default Unit
The result form changes as the unit changes.
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3.3.2.4 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 3-3-22, as Figure 3-3-23 shows:
Figure 3-3-23
Upper, lower Limit of Reference Input:
Click the input box of upper and lower limit to input the values.
Click after input. Click after the prompting of “Saving succeeded” 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 3-3-24
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 succeeded” indicates successful setting.
Figure 3-3-25
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3.3.2.5 Information Setting

(1)Department Information Setting:
Click “Information” in Figure 3-3-23, and select “Department Information” in the drop-down list of
“Information Type”, as Figure 3-3-26 shows:
Figure 3-3-26
a)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 .
b)Delete Department Information: Select the items need to be deleted in the department information list,
click .
(2)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
a)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 .
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b)Delete Doctor Information: Select the items need to be deleted in the doctor information list, click
.
(3)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.
(4)Sex Selection:
Select “Sex” in the drop down list of “Information Type”, as Figure 3-3-29 shows:
Figure 3-3-29
Select “Male” or “Female” in the sex list. Only the commonly used sex ID can be changed here.
(5)Age Unit Selection:
Select the “Age” in the drop down list of “Information Type”, as Figure 3-3-30 shows:
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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.
(6)Cost Category
Select “Cost Category” in the drop down list of “Information Type”, as following figure shows:
Figure 3-3-31
a)Cost category information addition: input cost category name in the Name input box, input mnemonic in
the ID input box, and then click “Add”.
b)Cost category information deletion: select the item to be deleted in the cost category information list, and
then click “Delete”.
3.3.2.6 Backup Setting
Select “Backup Setting” in Figure 3-3-30, as Figure 3-3-32shows:
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Figure 3-3-32
(1)Backup:
Periodical database backup can prevent data lose.
Single click 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 for saving.
(2)Data Recovery:
The backup data can be used to recover the previous data if software cannot 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 Automatic Rinsing Setting
Click Automatic Rinsing Setting. Then the following figure will pop up:
Figure 3-3-33
(1)Input automatic rinsing interval times in the input box of counter “Count Times” (between 10-200). The set
number is 100 which means automatic rinsing will be conducted after each 100 samples. The number will be 0
after rinsing.
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(2)Input rinse DIFF pool interval times in the input box of rinse DIFF pool “Count Times” (between 10-600).
The set number is 10 in the above figure, which means when the test times is no less than 10, DIFF pool
rinsing will be conducted before sleep (The software displays “Rinsing the instrument…”), then the instrument
will enter into sleep mode (in case of not conducting shutdown and manual rinse of the instrument in the
process of test).
3.3.2.8 Abnormal Mark Setting
Click “Abnormal Mark Setting”, select “WBC”, as the figure below shows:
Figure 3-3-34
Select “RBC/PLT”, as the figure below shows:
Figure 3-3-35
The prompt range of WBC, RBC/PLT abnormal alarm information can be set in this interface.
Click for saving after input, click “Default Value” to recover, click to cancel the
interface.
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Chapter4 Calibration
Calibration of the instrument is to ensure the accuracy of the results. Calibration must be carried out before
test.
4.1 Calibration Frequency

The instrument calibration has been conducted in the factory. Calibration is still required in the following three
cases:
(1)Before first use.
(2)After main part replacing.
(3)Obvious deviation exits in QC running.
4.2 Calibration Method

The instrument offers three calibration methods: manual calibration, calibrator calibration and fresh blood
calibration. In calibrator 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.
4.2.1 Preparation before Calibration
(1)Conduct the following checks before calibration. Contact the manufacturer's after-sales service department
for any problem.
(2)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.
(3)The Control and reagent specified by the manufacturer company should be used. The corresponding
operation should refer to the Control and reagent instruction.
4.3 Calibration with Calibrator
Calibration with calibrator should be conducted under whole blood mode.
Click “Calibration” of above menu, and select “Calibrator Calibration” in , as Figure

4-3-1 shows:
Figure 4-3-1
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(1)Calibrator Reference Value Input:

Click the corresponding line of “Reference”, input the value.
(2)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 20μL Calibrator and start calibration counting
automatically.
Figure 4-3-2
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 4-3-3
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 4-3-4
Operator should check the reference value input, if the reference value input is correct, operator delete
calibration results, re-run the calibration count.
(3)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.
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If this result is invalid, click “Delete” to delete the result.

(4)Calibration coefficient saving:
Click “Save” in Figure 4-3-1 after 5 times counting, the following box will pop up.
Figure 4-3-5
Click “OK” to save the calibration coefficient. It will be stored into calibration coefficient of “Manual Calib”
interface. As Figure 4-3-6 shows:
Figure 4-3-6
4.4 Fresh Blood Calibration

4.4.1 Fresh Blood Preparation
Use EDTA-K2 (1.5 mg/mL-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.
4.4.2 Fresh Blood Calibration
Fresh blood calibration needs to be conducted under “Whole Blood” testing mode.
Click “Fresh Blood Calib” in Figure 4-3-1 to enter fresh blood calibration interface, as shown in Figure 4-4-1.
Figure 4-4-1
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(1)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.
(2)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 4-4-1.
(3)Put the fresh blood under sampling probe, and press “Sample Aspiration”, the sampling probe will aspirate
20μL fresh blood and start calibration counting automatically.
Figure 4-4-2
(4)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.
(5)The instrument will carry out different process according to different results.
The following box will pop up if the results obtained beyond the scope.
Figure 4-4-3
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:
Figure 4-4-4
Operator should check the reference value input, if the reference value input is correct, operator delete
calibration results, re-run the calibration count.
(6)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
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test, click “Test Result” again(mark √ ), indicating this test result is valid.
If this result is invalid, click “Delete” to delete the result.
(7)Calibration coefficient saving:
Click “Save” in Figure 4-4-1 after 5 times counting, the following box will pop up.
Figure 4-4-5
Click “OK” to save the calibration coefficient. It will be stored into calibration coefficient of “Manual Calib”
interface.
4.5 Manual Calibration

The calibration coefficient displayed on the screen is the calibration coefficient saved after calibration with
calibrator or fresh blood calibration.
Click “Manual Calib” in Figure 4-4-1 to enter manual calibration interface. As shown in Figure 4-5-1.
Figure 4-5-1
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”.
4.6 Calibration History

The software registers information of each calibration.
Click “Calibration History” in Figure 4-5-1 to enter calibration log interface, as shown in Figure 4-6-1.
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Figure 4-6-1
The date, mode, calibration method and detail test value of latest 100 times calibration will be displayed. If
calibration counting is more than 100 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.
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Chapter5 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 methods: L-J QC, X QC and X-B floating mean methods.
5.1 L-J QC
Under “L-J” QC, the operator can carry out quality control of 24 parameters. The instrument provides 12 QC
documents in order to save quality control parameter and result. Each quality control document can save up to
400 groups of quality control results. When the number of quality control is more than 400, the new QC result
will cover the old result.
Click “QC” of main interface and select “L-J/Xbar” in , as shown in Figure 5-1-1.
Figure 5-1-1
5.1.1 Quality Control Setting

5.1.1.1 Lot No. Information Setting
QC information can be set through setting button.
Click set, as shown in Figure 5-1-2.
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Figure 5-1-2
(1)Select Document No.
Click the drop down list of document No. to select the document needs QC, the range is 1~12.
(2)QC Lot No. Input:
Input the corresponding Control lot No. in the drop-down list of “Lot No.” according to Control instruction.
(3)Validity Setting:
Click the drop down list of “Validity” to input the validity according to the instruction.
(4)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. “Saving Succeed” will pop up, and click “OK”.
(5)Target Value, SD Input:
Input the target value and SD according to the QC instruction.
The input lot No., validity should be the validity marked on the instruction.
5.1.1.2 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.
(1)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 5-1-3 shows:
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Figure 5-1-3
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 5-1-3, 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 5-1-2.
(2)Delete Abnormal QC point
If abnormal QC point occurs, preset value can be obtained after abnormal point deleting. The operating steps
are as follow:
Figure 5-1-4
Click “OK” of above figure, the screen will be switched into QC interface, as Figure 5-1-5 shows:
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Figure 5-1-5
a)If the second point on the left is abnormal point, click it, the red cursor line 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.
b)Click “Calculation” after the points are deleted, the screen will return to “Setting” interface, and the result
will be displayed.
c)If the valid QC point number is less than 3, click “Preset Value”, Figure 5-1-6 will pop up:
Figure 5-1-6
d)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).
Valid QC points are taken as reference and deviation limit when taking preset value.
5.1.2 QC Counting
Click QC count in Figure 5-1-5 to enter QC counting interface, as shown in Figure 5-1-7.
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Figure 5-1-7
The specified Control of the manufacturer should be used to avoid QC result error.
See the instruction for the use of Control.
The result will not be reliable when the instrument failure occurs.
(1)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 20μL Control automatically to conduct QC counting.
Figure 5-1-8
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 5-1-9
Click “Cancel” in above figure, this result will be deleted.
(2)QC Data Query
The stored QC result can be queried through button “Next” and “Previous” under “Position/Total Number”
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after QC counting. If QC results are out of QC ranges, red is displayed in corresponding columns.
(3)QC Data Modification
After QC tests, if the results need to be modified, double-click them, and then make modification, click “Save”
button to save modified results.
(4)QC Data Print
To print single QC results, click “Print” button to print current records.
(5)QC Data Deletion
To delete current QC results, click “Delete” button to delete current records.
5.1.3 QC Result Review
Click QC Graph in Figure 5-1-7 to enter the review interface, as shown in Figure 5-1-10:
Figure 5-1-10
(1)QC Graph Setting:
Click Setting in “QC Graph” interface to set the parameters or move the display position, as Figure 5-1-11
shows:
Figure 5-1-11
a)QC Item Setting:
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Select the parameter name in Figure 5-1-1, click “OK”, only the selected parameter will be saved.
b)QC Item Moving:
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.
(2)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 400
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 numbers on the right of the QC chart represent Mean, SD and CV% respectively.
(3)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.
(4)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 the manufacturer’s after sales service department if abnormity remains after calibration.
(5)QC chart printing:
Click Print in Figure 5-1-10, if “Preview before print” is selected in print setting, preview can be conducted
before printing, as the following figure shows:
Figure 5-1-12
Connect the printer, click to print the report.
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QC graph query: select “Start date” and “End date”, and then click “Query” to check the corresponding QC
graph.
5.1.4 QC List
Different QC documents can be queried.
Click “QC List” in Figure 5-1-10, and select the QC document No. in the drop down menu of “Document No.”
to enter the interface of Figure 5-1-13:
Figure 5-1-13
(1)Delete All: The operator can delete all QC results of current QC document.
Click “Delete All” in Figure 5-1-13, as Figure 5-1-14 shows:
Figure 5-1-14
Click “Yes”, the interface will display “Delete Succeed”, which indicates that all QC results are deleted.
(2)Delete: The operator can delete some QC results of current QC document.
Select the QC data need to be deleted in figure 5-1-13, click “Delete”, as figure 5-1-14 shows, click “Yes”, the
interface displays “Deleting Succeed”, which indicates the selected QC results are deleted.
(3)Export: The operator can export the QC counting result of current QC document.
(4)Import: the operator can import the QC counting result.
(5)Communicate: The operator can transmit the QC counting result of current QC document to LIS.
5.2 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 “5.1 L-J QC”.
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5.3 X-B QC
X-B floating average method is proposed by Dr. Brian Bull. It monitors instrument performance through
monitoring stability of red blood cell parameters, such as MCV, MCH, MCHC, etc. 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 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 conducts X-B QC toward MCV, MCH, and 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.
Calibration is needed before testing, because X-B reference value is obtained through analyzing a large
number of random samples.
5.3.1 QC Setting
The QC parameters need to be set before X-B QC analysis.
(1)Click “Setting” in main menu, and select “QC Setting” in the left menu, open “X-B” interface, as Figure
5-3-1 shows:
Figure 5-3-1
Sample No. selected for each X-B point can be 20-200, the recommended number is 20.
Click ON under “X-B QC”, click “Apply”, “Saving succeeded” will pop up, click “OK”.
(2)Click “QC” in above menu, and select “X-B” in , as Figure 5-3-2 shows:
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Figure 5-3-2
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.
Target and deviation limit cannot be blank.

(3)Click “Save” after setting, “Saving Succeed” will pop up, click “OK”.
5.3.2 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.
5.3.3 QC Graph Review
Click “QC Graph” in Figure 5-3-2 to enter into X-B QC graph review interface, as shown in Figure 5-3-3.
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Figure 5-3-3
(1)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 numbers on the right of the QC graph represent Mean, SD, and CV%
respectively.
(2)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.
(3)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 the manufacturer’s after sales service department if abnormity remains after calibration.
(4)QC data checking
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.
5.3.4 QC List Review
Click QC list in Figure 5-3-3 to enter the X-B QC list review interface, as shown in Figure 5-3-4.
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Figure 5-3-4
(1)Delete: Click the QC data behind corresponding No., the line will turn blue, click “Delete”, as Figure 5-3-5
shows:
Figure 5-3-5
Click “Yes” in above figure, “Delete Succeed” will be displayed; the selected records will be deleted.
Reference range and deviation limit cannot be deleted.

(2)Delete All: Click “Delete All”, as Figure 5-3-6 shows:
Figure 5-3-6
Click “Yes” in above figure, “Delete Succeed” will be displayed, all records will be deleted.
(3)Export: Click “Export” to enter Figure 5-3-7:
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Figure 5-3-7
Input the document name in the input box behind “Document Name”, and select the saving path, click “Save”.
Note:
The exported document will be saved in EXCEL form.
(4)Import: Click “Import”, the operator can import the QC counting result in the interface.
(5)LIS Transmission: Click “LIS Transmission”, the data will be transmitted to LIS, as the following figure
shows:
Figure 5-3-8
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Chapter6 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 6-1-1:
Figure 6-1-1
6.1 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 barrel.
(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.
(5)Check the barcode reader
Check the connection between the computer and the barcode reader.
6.2 Daily QC
QC analysis should be conducted every day before sample analyzing to ensure reliable result. Refer to
chapter 6 for operation.
6.3 Sample Preparation

6.3.1 Whole Blood Sample Preparation
(1)Use clean EDTA-K2 (1.5 mg/mL -2.2mg/mL blood)anti freezing vacuum tube to collect venous blood
sample for more than 1mL.
(2)Mix the venous blood with anticoagulant promptly.
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● Use clean EDTA-K2 anti freezing vacuum blood collecting tube, silicified glass/plastic tube and 20μL
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.
6.3.2 Add Diluent
(1)Click in shortcut area, the screen display as Figure 6-3-1, 6-3-2 shows:
Figure 6-3-1
Figure 6-3-2
(2)Take a clean tube or centrifuge tube, place it under the sampling probe, as Figure 6-3-3 shows:
Figure 6-3-3
(3)Press aspiration key, the diluent will be dispensed into the tube, the screen displays as Figure 6-3-4 shows:
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Figure 6-3-4
Ensure all the diluent(180μL)is added into the tube. Move the tube.
(4)And put 20 μL peripheral blood into the tube follow the tube wall. Mix them.
(5)Click “Cancel” in Figure 6-3-2, as Figure 6-3-5 shows:
Figure 6-3-5
Cancel diluent adding to finish preparation of diluted sample.
(6)If there are some samples needing to be diluted after the first one, the interface will be as Figure 6-3-2,
repeat the first process to finish other sample dilution. About 20 sample dilution can be done continuously.
● The operator can also use pipette to aspirate 180μL diluent and dispense it into the tube follow the
tube wall. And add 20 μL 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.
6.4 Sample Testing of Whole Blood Mode

6.4.1 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”.
The pipeline should be rinsed when “Predilution” is switched into “Whole Blood”.
(1)In main interface, press the . As shown in Figure 6-4-1:
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Figure 6-4-1
(2)In “Mode”, blood sample mode is whole blood or predilution.
(3)The testing mode is “CBC” or “CBC+DIFF”.
“CBC” mode: conduct counting without WBC differential. The result includes 14 parameters and RBC, PLT
histogram.
“CBC+DIFF” mode: conduct counting and WBC differential. The result includes 24 parameters, scattergram,
histogram and 10 research parameters.
(4)Input the next sample No. in “Sample No.” input box.
(5)Select the reference range in the drop down list of “Reference Range”, default as “General”.
● The maximum digit of sample No. is 15. Not all figures number should be “0”, otherwise, the software
prompts invalid input.
● Number to enter “-”, but not enter “.”
6.4.2 Sample Information Editing
Edit the waiting sample before analysis.
Click in main interface. As shown in Figure 6-4-2:
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Figure 6-4-2
6.4.2.1 Information Editing of Single Patient
Sample Information: refer to 3.2.1.1.
Patient Information: refer to 3.2.1.2.
6.4.2.2 Batch Patient Information Input
In batch patient information input, input one piece of 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”.
6.4.3 Sample Testing Steps
● 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 6-4-3):
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Figure 6-4-3
(1)Check the working mode is “Whole Blood Mode”. The green indicator in the middle of the front upper
cover is bright.
(2)Place the sample under the sampling probe. Make sure the probe can aspirate the mixed sample.
(3)Press “Counting” on instrument panel to start the sample testing. The sampling probe aspirate 20μL
sample.
(4)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.
(5)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.
(6)The instrument will save the test result after test.
(7)Conduct other sample testing according to this process.
(8)Click to enter into query interface, press “Print”, select “Current Record” or “Batch Print” to
print the report.
● 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.
● The result will be inaccurate if the temperature exceeds the normal working temperature range of the
instrument.
● If aperture is blocked during analysis, there will be ? behind the data, meanwhile “Aperture is clogged,
perform clog removal or rinsing aperture.” will be prompted. And the result will be inaccurate, thus test
should be conducted after “clog remove”.
6.4.4 Picture Check
Click “Picture” in Figure 6-4-3 to check the pictures of the test results, as Figure 6-4-4 shows:
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Figure 6-4-4
Histogram of RBC, PLT and WBC; histogram and scattergram of WBC 4 diff will be displayed.
6.4.5 Research Parameter Check
Click “Research Parameter/microscopic examination result” in Figure 6-4-4. Then the following figure will
pop up:
Figure 6-4-5
Print research parameters:
Select “Print research parameters” in “Setup”→“Print Setting ”. In case that “Input microscopic examination
result” is not selected, whether input the microscopy result in “Research parameter/microscopic examination
result” interface or not, click “ ” in above figure to print the research parameter.
In case that “Input microscopic examination result” is selected, when printing research parameter, if
microscopic examination result is not input, “Please input microscopic examination result” will be
prompted.
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6.5 Pre-dilution Sample Testing

Check the working mode is “Predilution Mode” in “Counting” interface (as Figure 6-4-3 shows), otherwise,
switch the current mode to “Predilution” mode.
The pipeline will be rinsed after mode switching.

(1)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.
(2)Press “counting” on instrument panel to start the sample testing. The sampling probe aspirates 80μL.
(3)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.
(4)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.
(5)The instrument will save the test result after test.
(6)Conduct other sample test according to this process.
(7)Click to enter into query interface, press “Print” or “Batch Print” to print the report.
● 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.
6.5.1 Parameter Alarm
Parameter alarm includes the following three situations:
If the result is marked with “↑”or“↓”, that means the result exceeds the reference range.
If the result displayed as “***”, invalid result or range exceeding can be indicated. If WBC counting result is
smaller than 0.5*109/L or bigger than 999*109/L , or the pre-dilution result is smaller than 2*109/L or bigger
than 999*109/L, the system will not conduct WBC differential, the relevant parameter displays as “***”.
If the result is displayed with “?”, then the result is unreliable.
6.5.2 Differential or Abnormal Form Alarm
The instrument can prompt alarm according to the histogram and scattergram. As shown in table 6-5-1:
Table 6-5-1
(1)WBC abnormity alarm information
Information Meaning Judging Standard
WBC scattergram abnormal ? WBC scattergram abnormal DIFF channel scattergram abnormal
WBC increase Higher WBC counting WBC>18.0*10^9/L
WBC reduction Lower WBC counting WBC<2.5*10^9/L
Neutrophil increase Higher neutrophil counting NEUT#>11.0*10^9/L
Neutrophil reduction Lower neutrophil counting NEUT#<1.0*10^9/L
Lymphocyte increase Higher lymphocyte counting LYM#>4.0*10^9/L
Lymphocyte reduction Lower lymphocyte counting LYM#<0.8*10^9/L
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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
(2)WBC unreliable alarm information

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

Abnormal RBC histogram
Abnormal RBC distribution Abnormal RBC histogram
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.
(4)RBC/HGB unreliable alarm information

RBC or hemoglobin may be Compare the result of hemoglobin with
RBC or hemoglobin unreliable？ inaccurate. RBC result
Hemoglobin Abnormal hemoglobin maybe
Calculate and compare the special
exists, or interference factor maybe
abnormity/interference？ analytic parameters.
exists.
(5)PLT unreliable alarm information

PLT increase PLT increase PLT>600*109/L
PLT reduction PLT reduction PLT<60*109/L
PLT histogram distribution
PLT distribution abnormity PLT histogram abnormity
abnormity
(6)PLT unreliable alarm information

Calculate and compare the special
PLT aggregation？ PLT aggregation maybe exists.
analytic parameters.
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6.6 Sleeping
When it reaches the set sleep time, the instrument will enter into sleeping status automatically, and the status
information will be displayed in failure area. Users can press Count key to wake up the instrument, and
proceed with the instrument.
6.7 Rinse and Clog Removal

The instrument will conduct automatic rinsing (sample flow parts) in each counting process to ensure that no
sample residue, rinse components are as follows:
(1)Internal and external wall of sampling probe.
(2)Counting pool.
(3)Flow cell.
When the instrument prompt “Aperture Clog”, click “Remove Clog” in “Service-Maintenance” interface(same
as conducting “Zap” and “Backflush” aperture).
6.8 Shutdown
In order to ensure the stability and accurate test result of the instrument, shutdown is required for the
instrument after 24 hours continuous working. The operator must follow these steps to turn off the
instrument.
Shutdown includes mainframe shutdown and software exit.
6.8.1 Shutdown Mainframe
(1)Click “ ” in main interface. As shown in Figure 6-8-1:
Figure 6-8-1
(2)Click “OK”, above figure will pop up. After shutdown liquid aspirating, “Shutdown instrument” 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 6-8-2
(3)Switch to “O” on the right of the instrument to finish shutdown.
(4)Empty the waste solution container after shutdown.
Click “Restart” in Figure 6-8-2 if more tests are needed.
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6.8.2 Exit Software
Click , or select “Menu”→“Exit System”, the following box will pop up:
Figure 6-8-3
Click “OK” to exit the software to finish the whole shutdown process.
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Chapter7 Record Query

The instrument will store the result into database automatically after each test. The maximum storage capacity
is 30000. 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 30000.
Click in main interface to enter into query interface, as Figure 7-1-1 shows:
Figure 7-1-1
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 cannot 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.
7.1 Record Selection

If the sample with known position needs to be queried, click “Select” in Figure 7-1-1, and select “Condition”
in its drop down list , as Figure 7-1-2 shows:
Figure 7-1-2
Input the “Start No.” and “End No.” need to be queried in figure 7-1-2, click “OK”. The sample will be
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selected with .
● 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.
7.2 Print
The sample results can be printed in sample query interface.
(1)Single sample Printing:
Click “Print” in Figure 7-1-1, if “Preview or not before printing” is selected in “Print Setting”, as the following
figure shows:
Figure 7-2-1
Click in above figure to print the report.
After printing the selected report, the current sample print status is , switch to the counting
interface, the print status on the printed report is “printed”.
(2)Bulk Print: Click “Bulk Print” in Figure 7-1-1, as Figure 7-2-2 shows:
Figure 7-2-2
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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 7-2-3
The selected & audited samples will be printed. If “Audited” is not selected, all selected samples will be
printed.
After printing the selected report, the current sample print status is , switch to the counting
interface, the print status on the printed report is “printed”.
7.3 Query
The data can be queried through different condition. Click “Query” in figure 7-1-1, and select “Condition” in
its drop-down list , as shown in Figure 7-3-1.
Figure 7-3-1
Users can select different query conditions to query, including: sample No., barcode No., test time, test mode,
case No., name, gender, and department, deliver doctor, auditor and tester. The results can be queried
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according to one condition or multi-condition.

7.3.1 Query Accroding to Sample No.
Input the sample No. in the box behind “Sample No.” need to be queried in Figure 7-3-1, if the input sample
No. is “14”, click “Query”, the sample results with No. “14” will be displayed, as Figure 7-3-2 shows:
Figure 7-3-2
7.3.2 Query According to ID Number

Input the ID No. in the box behind “Barcode” need to be queried in Figure 7-3-1, click “Query”, the results
will be displayed.
7.3.3 Query According to Test Mode and Date
In Figure 7-3-1, 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.
7.3.4 Query According to Case No.
Input the Case No. in the box behind “Case No.” need to be queried in Figure 7-3-1, click “Query”, the results
will be displayed.
7.3.5 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 7-3-1,
click “Query”, the results will be displayed.
7.3.6 Query According to Department and Deliver Doctor
Select the department of the sample in the drop-down list behind “Department”, and select the deliver doctor
of the sample in the drop-down list behind “Deliver Doctor” need to be queried in Figure 7-3-1, click “Query”,
the results will be displayed.
7.3.7 Query According to Auditor
Select the auditor of the sample in the drop-down list behind “Auditor” need to be queried in Figure 7-3-1,
7.3.8 Query According to Checker
Select the checker of the sample in the drop-down list behind “Checker” need to be queried in Figure 7-3-1,
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.
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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.
7.4 CV Calculation and Tendency Graph

7.4.1 CV Calculation
Users can select 3 or more records to calculate the CV, Mean and SD. If the selected record number is less
than 3, the interface will be:
Figure 7-4-1
Click the No. in front of record(√), and click CV, as Figure 7-4-2 shows:
Figure 7-4-2
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.
7.4.2 Tendency Graph
In Figure 7-4-2, click “Tendency Graph” button, and Figure 7-4-3 is shown:
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Figure 7-4-3
Parameter setting in tendency graph:
Click “Setting” button in Figure 7-4-3, and the following figure pops up:
Figure 7-4-4
The user can set parameter items to be queried according to needs: in front of parameters means
parameters are selected. The user can click Button “SetTop”, “Upward”, “Downward”, and “SetBottom” to
adjust the positions for parameters in the tendency graph. After the setting, click “OK” to exit.
Deviation limit setting of tendency graph:
Click the input box under “Deviation Limit” on the right of Figure 7-4-3.The user can enter a deviation limit
corresponding to the parameter on the left. After editing, click “Save” button.
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7.5 Bulk Audit

The user can conduct bulk audit in result query, click bulk audit in Figure 7-1-1, as Figure 7-5-1 shows:
Figure 7-5-1
Select the test date in the drop down list of “Test Date”, and input the start sample No. and end sample No.,
click “OK”, the auditor information of audited sample result will be displayed behind auditor.
7.6 Communication
Click “LIS” list review interface, and select proper records in list , the interface is as follow if
Input Range is selected.
Figure 7-6-1
Click “OK” after input. Data transmission can be conducted. The interface is as follow.
Figure 7-6-2
Manual data transmission is forbidden during counting.
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7.6.1 Sample Application
Select “Sample Application” from pull-down menu “ ”, and the following figure pops up:
Figure 7-6-3
Enter start and end sample number, and click “OK” button. Patient information can be applied from LIS
system. The applied patient information is saved in the record of an edited sample to be tested or a tested
sample in the software.
7.7 Delete
Click “Delete” in Figure 7-1-1, and select the records need to be deleted in its drop-down list , as
Figure 7-7-1 shows:
Figure 7-7-1
Click “OK” in above figure to delete the records.
7.8 Export
The exported data can be saved.
Click “Export” in Figure 7-3-2, select the data needs to be exported in its drop-down list , as the
following figure shows:
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Figure 7-8-1
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 7-8-2
Indicates successful data export.
The exported file should be saved in EXCEL form.
7.9 Sample Adding

In Figure 7-3-2, select a record and click “Add”. The number of the added sample is increased by 1. After the
addition, sample information and patient information can be edited. Click “Enter” or “Save” to save the
information. The test status of the newly-added sample is “to be tested”, the print status is ,
switch to the counting interface, the print status on the printed report is “unprinted”.
7.10 Patient information modification

From Figure 7-3-2, select a record, and modify information at the bottom of the patient information area. Click
“Enter” or “Save” to save the information.
7.11 Recheck
If the user doubts the accuracy of a certain test result, select the record and click the right button of the mouse
from Figure 7-1-1. Then Figure 7-11-1 pops up:
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Figure 7-11-1
Click “Recheck” in Figure 7-11-1. The status changes from “Tested” to “Recheck”. Carry out tests according
to the routine testing method. The status displays “Testing ...”. After tests, the status turns into “Tested”,
namely, the recheck is finished.
In the process of recheck, the status of counting interface is the same with what of result query.
7.12 Chart Query

User can check single record in chart form, in Figure 7-1-1, double click the sample result line, as Figure
7-12-1 shows:
Figure 7-12-1
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.
7.13 Review Compare

In the main interface, click “Test” and then click “Review”. The following figure pops up:
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Figure 7-13-1
In Figure 7-13-1, click “Review Compare”. Figure 7-13-2 pops up:
Figure 7-13-2
7.13.1 Parameter Setting

The user can set the displayed parameters after query, and also can move the display position of the parameters.
Click “Setting” in Figure 7-13-2, and Figure 7-13-3 pops up:
Figure 7-13-3
(1)Item Setting
From Figure 7-13-3, select parameter names to be displayed. And “ ” appears in check boxes. Click “OK”
button. After query, only results of selected parameters will be displayed.
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(2)Item Move Up, Move Down

To order the parameter that will be queried, select it (the line turns blue) and click “Move Up” or “Move
Down” button to move it.
7.13.2 Comparison List
Input name “1” and do not input case No. in Figure 7-13-2. Select a test time, and click “Query”.
Figure 7-13-4
All the test results whose name including “1” corresponding to the test time can be queried.
Input name and case No. in Figure 7-13-2, and select “Exact Search”. Select a test time, and click “Query”.
Then the user can query the result corresponding to the test time, name and case number.
7.13.3 Tendency
After query according to the method above, click “Tendency”, and select a corresponding parameter from the
“Parameter” pull-down menu. Figure 7-13-5 pops up:
Figure 7-13-5
If “WBC” is selected, WBC tendency can be queried, the lower part displays the WBC value of each record.
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By default, “ ”is ticked in the compare list, users can check the corresponding graph in the tendency
interface. If only one item is ticked, select corresponding parameter in the tendency interface, and only one
point will display in the graph.
7.14 Backup
Click “Backup” in Figure 7-13-1, and then Figure 7-14-1 pops up:
Figure 7-14-1
There are 3 types of test data backup:
(1)If the radio button “Selected Record” is clicked, selected records will be backed up. “Selected Records” are
those with “ ” in the data list.
(2)If the radio button “All Records” is selected, all the records in the database will be backed up.
(3)If the radio button “Input Range” is selected, after selecting the test date range, records within the range will
be backed up.
After selection, click “OK”, and Figure 7-14-2 shows:
Figure 7-14-2
Select a backup path, enter the name of the file to be backed up, and click “Save”. Figure 7-14-3 is shown:
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Figure 7-14-3
After backup, the following figure pops up. Click “OK” to exit.
Figure 7-14-4
In addition, QC data backup, Calibration coefficients backup and set data backup can be selected, all the
backup contents will be recovered if necessary.
● It's forbidden to select the type of a backup file.

● The contents of the backup data cannot be modified; only can be queried.
7.15 Restore
When the data saved in the database is damaged but the backup data is intact. Click “Restore” in Figure 7-13-1,
and then Figure 7-15-1 pops up:
Figure 7-15-1
Select the file path and file name, click “Open” and Figure 7-15-2 pops up:
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Figure 7-15-2
After data recovery, Figure 7-15-3 pops up:
Figure 7-15-3
Click “OK” to exit. Backup data are displayed in the database.
7.16 Help
Click “Help” in the menu to enter into Component Maintenance interface, and check the service condition of
the components, as following figure shows:
Figure 7-16-1
All the buttons should be dimmed. If any button is highlighted, the corresponding test item should be checked
or the corresponding component should be replaced. Please contact the after-sales service of the manufacturer
and ask the professionals for maintenance advice.
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Chapter8 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.
● Don’t spill reagents, samples, waste liquid, etc over the mechanical or electrical parts of the
instrument, so as to avoid damage.
● While working, the operator should tack protective action, such as wearing protective gloves and
putting on labor clothes; otherwise, he/she may be infected when in contact with the contaminated area
and liquid. In case of contact with contaminated liquid, wash with water immediately and perform
sterilization.
● During cleaning and maintenance, pay attention to the parts holding liquid; the failure of them may
lead to danger.
● The instrument includes a laser device. The operator should pay attention to the related warning
labels during maintenance. Do not stare at the light beam directly or through optical devices.
● Improper maintenance may damage the instrument. The manual must be followed in maintenance.
● Contact the manufacturer's after-sales service department for unclear answers of the manual.
8.1 Maintenance Guide

8.1.1 Regular Maintenance
(1)Daily:
QC should be conducted before daily analyzing. Refer to chapter 5 for QC operation.
If the instrument is on a 24-hour run, users should conduct “Rinse Instrument” daily. Click the key
in the shortcut key area of the main interface to conduct the rinse operation. Or users can set the numbers of
automatic rinse intervals in “Setting”: 10-200. When a certain number of tests have been conducted, the
instrument will rinse itself automatically.
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).
(2)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).
(3)Every month:
Swab rinsing should be conducted each month if daily shutdown is conducted(Service-Maintenance-Rinsing).
For the first use of the 10mL detergent, take the 10mL detergent bottle out of the package, open the
cover, take out the rubber plug and pour 5mL -10mL detergent (about half a bottle of detergent) from
the 500mL detergent bottle to the 10mL detergent bottle. Then open the front door of the instrument,
put the 10mL detergent bottle in the reagent bottle slot which is in the middle of the counting unit (with
black cover). For the continuous use, when changing 500mL detergent, the 10mL detergent also needs to
be changed in accordance with the above steps.
8.1.2 Maintenance in Need
If the counting pool has been contaminated, conduct “Counting Pool Rinsing”.
When the instrument has not been used for 2 weeks or more, replace the reagent with distilled water, conduct
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“Rinse Pipeline” of “Maintenance”, and stop the distilled water, conduct “Empty Pipeline”, and place the
instrument at a clean place.
When the instrument prompt “clog” failure, press “Remove” to conduct manual remove or conduct “ Zap” and
“Backflush”.
Carry out priming if it has not been used for a long time.
The instrument will prompt “Soaking with Detergent” if the set counting number of software has been
conducted.
The reliable results can be obtained under the condition of normal working environment and state.
See the failure solution if other failure information is prompted.
8.2 System Status

System status is used to display the current status. Basic status, system version can be checked in this interface.
8.2.1 System Version
Click “Service”(Figure 8-2-1) , and then click in front of System Version in the left tree to view the
version information of software, mainboard, collection board, temperature control board, laser driver board
and mechanism.
If “Mainboard” is selected, the version of software, hardware and update package will be displayed. See figure
8-2-2.
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
The version numbers shown in the figures above are just for reference, because the software version will
change as the system upgrades.
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Select “Instrument Information” in its drop down menu, as Figure 8-2-3 shows:
Figure 8-2-3
The information has been set before delivery. You can just view. Modification is not allowed.
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:
(1)Temperature: Real-time temperature of reaction pool, working environment and laser, and also the normal
range. When the room temperature is lower than 15℃ and is higher than the set lowest temperature or the
room temperature is higher than 30℃ and is lower than the set highest temperature, “the room temperature is
out of the normal range” will prompt at the bottom right of the software interface.
(2)Pressure: Pressure of pressure reducing valve and normal pressure range.
(3)Voltage: Display 55V, 5V, voltage of WBC aperture, RBC aperture and normal range.
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(4)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 occurs, 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, valve detection is an important way to
solve pipeline failure.
Its operation is as follow:
Click the No. of the valve(No. of Figure 8-3-1 indicate valves), the instrument will conduct valve detection
automatically. Valve ON sound indicates normal valve.
8.3.3 Pump Detection
Click “Positive Pressure” or “Negative Pressure” to check the pump voltage.
Valve detection and voltage detection cannot 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 instrument, the software provides a number of
maintenance functions.
8.4.1 Replacement / Priming
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
Reagent replacement and filling can be conducted. Users can conduct when installing the
instrument for the first time or after the reagents are used up. To replace a single reagent, see the following
operation:
(1)FDO Lyse Replacement:
Click “Replace FDO Lyse” when bubble exits in FDO Lyse 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
After replacing FDO Lyse, the following box will pop up:
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Figure 8-4-4
Click “OK” to finish the replacement of FDO Lyse.
Click “Cancel” in figure 8-4-2 to cancel FDO Lyse replacement.
(2)FDT Lyse Replacement:
Click “Replace FDT Lyse” when bubble exits in FDT Lyse 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 Lyse. About 2 mins…”, After replacing FDT Lyse, “Operation finished” box will pop up, click “OK” to
finish the replacement.
Click “Cancel” to cancel FDT Lyse replacement.
(3)SLS-I Lyse Replacement:
Click “Replace SLS-I Lyse” when bubble exits in SLS-I Lyse pipeline, or SLS-I reagent is polluted, or SLS-I
reagent has been used up. The confirm interface will pop up. Click “OK”, pop up progress bar “Replacing
SLS-I Lyse About 2 mins…”, After replacing SLS-I Lyse, “Operation finished” box will pop up, click “OK”
to finish the replacement.
Click “Cancel” to cancel SLS-I Lyse replacement.
(4)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 7 mins…”,
After replacing Diluent, “Operation finished” box will pop up, click “OK” to finish the replacement.
Click “Cancel” to cancel Diluent replacement.
(5)Detergent Replacement:
Click “Replace Cleanser” when bubble exits in Detergent pipeline, or Detergent is polluted, or Detergent has
been used up. The confirm interface will pop up. Click “OK”. As shown in following figure:
Figure 8-4-5
Conduct Detergent replacement.
Click “Cancel” to cancel Detergent replacement.
(6)FDO Lyse Priming:
Click “Prime FDO Lyse” when FDO Lyse being emptied. The following box will pop up:
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Figure 8-4-6
Click “OK”, as shown in Figure 8-4-7:
Figure 8-4-7
Operation Completed box will pop up after FDO Lyse priming. Click “OK” to finish the priming of FDO
Lyse.
In the “fault information area”, clear the corresponding error message, the instrument automatically
conduct FDO Lyse priming when the software prompt FDO Lyse insufficiency.
(7)FDT Lyse Priming:
Click “Prime FDT Lyse” after FDT Lyse 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 Lyse insufficiency.
(8)SLS-I Lyse Priming:
Click “Prime SLS-I Lyes” after SLS-I Lyse is emptied. And the operation should be conducted as the prompts.
conduct SLS-I Lyse priming when the software prompt SLS-I Lyse insufficiency.
(9)Diluent Priming:
Click “Prime Diluent” after Diluent is emptied. And the operation should be conducted as the prompts.
conduct Diluent priming when the software prompt Diluent insufficiency.
(10)Detergent Priming:
Click “Prime PK” after Detergent is emptied. And the operation should be conducted as the prompts.
conduct Detergent priming when the software prompt Detergent insufficiency.
8.4.2 Rinsing
Select “Rinse” in Figure 8-4-1, as Figure 8-4-8 shows:
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Figure 8-4-8
(1)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.
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.
(2)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.
(3)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.
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(4)In order to avoid sampling component contamination, swab rinsing should be conducted after one month’s
running.
Click “Rinse Swab” in Figure 8-4-8. The confirm box will pop up, click “OK”, as figure 8-4-11 shows:
Figure 8-4-11
Place the detergent used for probe rinsing under sampling probe and press sample aspiration key. Progress bar
will pop up. “Operation Complete” will pop up after swab rinsing, click “OK” to finish the whole process.
Click “Cancel” to cancel swab rinsing in confirm box.
(5)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.
(6)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 Complete” 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.
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
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buffer bottle as an example:

(1)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 Pool”, “Empty RBC Pool”, “Empty DIFF Pool”, “Empty FDO
Lyse”, “Empty FDT Lyse”, “Empty SLS-I Lyse” and “Empty Diluent” is same as “Empty WC”.
(2)Click “Empty Pipeline” in Figure 8-4-12 when the instrument will not be used for 1-2 days. Place the
instrument at a clean position after pipeline emptying.
(3)Replace the reagent with distilled water when the instrument will not be used for more than 1 week. Click
“Package Clean Pipe” in Figure 8-4-12. Place the instrument 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 “Remove Clog”, 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.
(1)RBC Pool Soaking:
RBC pool soaking should be conducted every other week, the operation is as follow:
Click “RBC Pool” in Figure 8-4-12, as Figure 8-4-15 shows:
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Figure 8-4-15
Click “OK” in above figure, as Figure 8-4-16 shows:
Figure 8-4-16
The following box will pop up after soaking:
Figure 8-4-17
Click “Next” in Figure 8-4-17 to empty RBC, as the following figure shows:
Figure 8-4-18
Operation has been finished after emptying, as the following figure shows:
Figure 8-4-19
Click “OK” to finish the whole process.
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(2)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 8-4-20 shows:
Figure 8-4-20
Click “OK” in above figure, as 8-4-21 shows:
Figure 8-4-21
Click “Next” , to empty WBC, as the following figure shows:
Figure 8-4-22
(3) 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 8-4-23 shows:
Figure 8-4-23
Click in above figure. As Figure 8-4-24shows:
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Figure 8-4-24
The interface will pop up after soaking, as Figure 8-4-25 shows:
Figure 8-4-25
Click “Next”, as the following figure shows:
Figure 8-4-26
“Operation Complete” will pop up after emptying.
8.4.4 Reagent Registration
Click “Reagent Register” in Figure 8-4-12, the screen display as Figure 8-4-27 shows:
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Figure 8-4-27
(1)Input the barcode information manually:
Manual barcode information input can be conducted if the external barcode reader is not connected.
Click barcode input box in figure 8-4-27 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).
(2)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.
(3)Prompts for scanning failure:
The following information will be prompted if scanning failed:
Figure 8-4-28
Input the information after checking if above condition occur. Contact the manufacturer or his distributor for
continuous failure.
The following box will pop up if the barcode has been used:
Figure 8-4-29
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Change another bottle of reagent if above condition happened.

(4)After reagent registration, “After registration please replace the corresponding reagents” will pop up. Please
replace the reagent in “Maintenance” → “Replace/Prime” interface.
Do NOT stare at the scanning beam during the instrument 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 follows:
The pump positions are as follows:
Sample Pump
Figure 8-5-1
1 5
2 4
3
1 SLS-I Syringe Pump 2 FDO Syringe Pump 3 FDT Syringe Pump 4 Test Pump 5 Diluent Pump
Figure 8-5-2
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8.6 System Log
Click “Log” in main interface, and select “Error Log” in its drop-down list , as Figure 8-6-1
shows:
Figure 8-6-1
The operator can also select “Operation Log” and “Failure Log” in its drop-down list for checking.
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Chapter9 Failure Handling

This chapter describes various types of possible failure, the reason of the failure, and the solutions.
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.
9.1 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 9-1-1
will pop up:
Figure 9-1-1
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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9.2 Failure Information and Solution

Alarm
Alarm Statement Solution
Code
1.Click Clear to clear this failure.
[E00011] Dilute Motor Error
2.Check whether dilution motor failure occur.
[E00017] Dilute Motor Sensor Error
2.Check whether dilution motor sensor failure occur.
1.Click Clear button to automatic clear failure.
[E00024] Swab motor error
2.Check whether swab motor failure occur.
[E00025] Swab clean motor error
2.Check whether swab motor failure occur.
1.Please check whether SLS-I Lyse is sufficient.
2.Please replace new reagent if there is no reagent and clear the
[E00005] SLS-I Lyse Empty
failure.
3.Check the floater switch if the reagent is sufficient.
Data Collection Board Verification 1.Click Clear to clear this failure.
[E00022]
Error 2.Please check the data collection board if this failure remains.
2.Please check whether the data collection board has been
Data collection board is
[E00021] connected if this failure remains.
disconnected
3.Please check whether the data collection board has been
damaged.
2. If this failure remains, please check whether the heater has
been damaged. replace it if it is damaged.
[E10004] Laser temperature is too high. 3.Please check whether the thermistor has been damaged. replace
it if it is damaged.
4.Please check whether the overheat protector has been damaged.
replace it if it is damaged.
[E10005] Laser temperature is too low. 3.Please check whether the thermistor has been damaged. replace
2.Please check the temperature sensor connection if this failure
Laser temperature sensor
[E10006] remains.
disconnected.
3.Please check whether the temperature sensor has been
damaged. replace it if it is damaged.
1.Please make sure the ambient temperature is within normal
range[15.30]℃.
[E10007] Room temperature is too high.
3. If this failure remains, please replace temperature sensor.
1.Please make sure the ambient temperature is within normal
range[15.30]℃.
[E10008] Room temperature is too low.
3. If this failure remains, please replace temperature sensor.
Room temperature sensor
[E10009] remains.
disconnected.
[E10001] WBC pool temperature is too high. 3.Please check whether the thermistor has been damaged. replace
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Alarm
Code
[E10002] WBC pool temperature is too low. 3.Please check whether the thermistor has been damaged. replace
WBC pool temperature sensor
[E10003] remains.
disconnecting
[E00010] Test Motor Error 2.Please check whether test motor failure occur if this failure
remains.
[E00016] Test Motor Sensor Error 2.Please check whether test motor sensor failure occur if this
failure remains.
[E00023] Sheath motor error
2.Check whether sheath motor failure occur.
[E00026] Sheath motor limit error
2.Check whether sheath motor failure occur.
1.Empty waste barrel or replace it with new waste barrel.
2.Please check the connection between sensor and mainframe if
[E00003] Waste Barrel Full
this failure remains.
3.Check the floater sensor.
[E00013] Sampling Motor Error
2.Please check the sampling motor if this failure remains.
[E00019] Sampling Motor Sensor Error
2.Please check the sampling motor sensor if this failure remains.
[E00001] Waste Bottle Full 1.Empty waste barrel or replace it with new waste barrel.
[E00009] x-Axis Motor Error
2.Please check X axis motor if this failure remains.
[E00015] x-Axis Motor Sensor Error 2.If this failure still exist. check if failure occure on the sensor
of X-axis motor.
[E00027] x-Axis Motor First Sensor Error
2.Please check X axis motor sensor 1 if this failure remains.
[E00028] x-Axis Motor Second Sensor Error
[E00029] x-Axis Motor Third Sensor Error
[E00030] x-Axis Motor Fourth Sensor Error
x-Axis Motor Sensor Error
2.Please check X axis motor sensor if this failure remains.
[E00008] Y-Axis Motor Error
2.Please check Y axis motor if his failure remains.
[E00020] Front door is opened 1.Click Clear to clear this failure automatically.
1.Please check whether there is diluent in the diluent bottle.
2.Replace a new diluent if there is no diluent in the bottle. Click
[E00004] Diluent Barrel Empty
Clear to prime diluent.
3.Check the floater switch if the diluent is sufficient.
1.Please check whether the diluent has been contaminated.
HGB background voltage exceeds
[E10016] 2.Click Clear if diluent has not been contaminated to clear this
range
failure.
[E10011] 5V Voltage Exceeds Range
2.Please replace the circuit board if this failure unrestored.
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Alarm
Code
[E10013] 58V Voltage Exceeds Range
2.Please replace the circuit board if this failure remains.
[E10015] Laser Current Exceeds Range
2.Please replace the circuit board if this failure remains.
1.Please check whether FDO Lyse is sufficient.
[E00006] FDO Lyse Empty
failure.
1.Please check whether FDT Lyse is sufficient.
[E00007] FDT Lyse Empty
failure.
[E00012] Lyse Motor Error 2.Please check whether lyse agent motor failure occur if this
failure remains.
[E00018] Lyse Motor Sensor Error 2.Please check whether lyse agent motor sensor failure occur if
this failure remains.
1.Please check whether there is diluent in the diluent bottle.
2.Replace a new diluent if there is no diluent in the bottle. Click
[E00002] Diluent Bottle Empty Clear to prime diluent.
3.Check the floater switch if the diluent is sufficient.
4.Check whether No.6 or 12 valve is working normally.
2.Please check the air pump if failure remains.
[E10010] Pressure Error
3.Please check the air pipe connection.
4.Please adjust the pressure regulating valve.
[E00014] Y Axis Motor Sensor Error
2.Check whether Y axis motor sensor failure occur.
1. Check control board chip TPIC6A595.
[E00032] Valve check error
2. Reset MU.
Data collect board communication
[E00033] 1. Check data collect board joint.
error.
[E30001] Control board reset error Change control board.
[E30002] Data colloct board reset error. Change data colloct board.
Temperature controller board reset
[E30003] Change temperature controller.
error.
[E30004] Sampler board reset error Change sampler board.
1. Please check waste liquid pump .
[E40001] Row of waste liquid fault error.
2. Please check waste liquid valve .
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Chapter10 Transportation and Storage
10.1 Transportation
The transportation of the instrument should be in accordance with the contract stipulation. It should avoid
violent collision and should be protected from corrosive materials.
10.2 Storage
The packaged instrument should be kept in a well-ventilated room without corrosive gas, the temperature
should be -10℃～40℃, the relative humidity should be no more than 75%.
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AppendixA Network Communication Interface Protocol V1.1

This protocol is used for information transmission between BF Series Automatic Hematology Analyzer
(Model: BF-6500) and LIS. It is based on HL7 standard, HL7 version is 2.4.
A.1 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.2 Message Segment Used in this Protocol

(1)MSH-message head
(2)PID-patient information
(3)PV1-case history
(4)OBR-test report information
(5)OBX-test report test information
(6)EQU –instrument detail
(7)NDS - instrument affiche detail
A.3 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,
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message separator value, message type and message coding method and so on, it is each HL7 message’s first
message segment.
Information Example:
MSH|^~\&| XXX |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 after message
Field
1 1 1 segment, used for regulating other message |
Separator
field separator value
Coded Include discreteness separator, repeat
2 4 4 ^~\&
Character separator, ESC, sub-discreteness separator
Send Send terminal apply program
3 7 180 XXX
Program value: XXX
Instrument Sending terminal instrument, value:
4 10 180 1234567890
Code instrument code
Message created time (form
2011031014
7 Send Time 14 26 As YYYY[MM[DD[HH[MM[SS]]]]]) ,
4704
Take system time value
Message type, form as “information type”
Message
9 7 7 event type, value: ORU^R01(Sample) ORU^R01
Type
OUL^R21 (LJ/X, XB QC)
Message Message control ID is used for only mark
10 20 20 361
Control ID one message, value :PID
This field is used for decide on whether to
transact HL7 operation program’s (7th layer)
Transact ID
11 3 3 transact rule definition information. P^S
NO.
Value: P^ message type (Type Value:
S-sample, LJ-LJ /X barQC, XB-XB QC)
HL7 Version Agreements adopt HL7 version No. Value:
12 3 60 2.4
NO. 2.4
17 Nation Code 3 3 Nation code mark, refer to HL 7 2.4 CHN
ISO/IEC 10646-1-1993 International
18 Character Set 10 10 UTF-8
character standard 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>
Serial HL7 Advice
NO. Length
Case History Patient ID, here used for patient case history
2 20 20 1234567890
no. NO.
Wang San
5 Name 50 250 Patient name
Qiang
8 Gender 10 1 Gender, showed as character string M
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>
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Serial Field HL7 Advice

Length Explanation Example
NO. Name Length
Pointed
3 patient 80 80 form as :department^^bed no. ^^clinic 235689
position
Deliver
7 50 250 deliver doctor, character string 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>
Serial HL7 Advice
NO. Length
Sample
Sample number in testing
2 Serial 16 22 23
Document No. in LJ/X QC
Number
Barcode ID in sample testing
3 Scan No. 32 22 31C3F010230DFB03
Lot No. in LJ/X QC
Service ID symbol, used for sign on
Data
different count result type.
4 Service 200 200 0001^Count Results
Idiographic value check the appendix
Type
OBR-4 message coding definition.
Sample Sampling time in testing.
6 14 26
Time Validity in LJ/X quality control
Counting time in sample information
7 Count Time 14 26 Count time in LJ/X QC
Count time in X-B quality control
Delivery
14 14 26 delivery time.
Time
Tube Rack
18 2 60
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>
Serial HL7 Advice
NO. Length
Serial Used for mark different OBX message
1 10 10 1
NO.ID segment
Test result’s data type, value is “ST”,
2 Data Type 3 3 ED
“NM”, “ED”, “IS” etc.
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Serial HL7 Advice

NO. Length
Test item mark. Form as “ID ^ Name”, ID
is test item mark, Name is test item
descript information. Each test item serial
3 ID Symbol 250 250 no. value 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, Test result data, could be number,
chart data, character string, enumerate value, binary
notes, system etc, data specific value reference
5 65536 65536
quality the enumerate value table.( Binary data
control such as histogram and scatter plot, using
level…… Base64 encoding to do conversion)
Unit, note: “^” in unit conflicts with
6 Unit 10 250 discreteness separator, so use “*” to 10*9/L
instead
Test Result The scope of the test results, forms: “the
7 Reference 20 60 reference range lower limit - upper limit 12.463-33.569
Value of reference range”
Test Result Test result condition. Value is “F” -
11 20 20 F
Condition (Final Result). Shows final test results
This protocol uses 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
2009 V_NEU_c The number of neutrophils NM 2009^V_NEU_c
The number of acidic
2010 V_EOS_c NM 2010^V_EOS_c
granulocyte
2011 V_LYM_c The number of lymphocytes NM 2011^V_LYM_c
The number of mononuclear
2012 V_MON_c NM 2012^V_MON_c
cells
2013 V_BAS_p The percentage of basophils NM 2013^V_BAS_p
2014 V_NEU_p The percentage of neutrophils NM 2014^V_NEU_p
2015 V_EOS_p The percentage of eosinophils NM 2015^V_EOS_p
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Code Name Explanation Value Type OBX-3 Field

2016 V_LYM_p Lymphocyte percentage NM 2016^V_LYM_p
2017 V_MON_p percentage of Monocytes NM 2017^V_MON_p
2018 V_RBC The number of red blood cells NM 2018^V_RBC
2019 V_HGB Hemoglobin NM 2019^V_HGB
2020 V_MCV MCV NM 2020^V_MCV
2021 V_MCH Mean corpuscular hemoglobin NM 2021^V_MCH
Mean corpuscular hemoglobin
2022 V_MCHC NM 2022^V_MCHC
concentration
Coefficient of variation of red
2023 V_RDW_CV NM 2023^V_RDW_CV
blood cell distribution width
Standard deviation of red blood
2024 V_RDW_SD NM 2024^V_RDW_SD
cell 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
2028 V_PDW Platelet distribution width NM 2028^V_PDW
2029 V_PCT Platelet hematocrit NM 2029^V_PCT
2030 V_P_LCR Platelet - macrophage ratio NM 2030^V_P_LCR
2101^RBC
2101 RBC Histogram.BIN RBC scattergram BMP data ED
Scattergram.BMP
2102^PLT
2102 PLT Histogram.BIN PLT scattergram BMP data ED
Scattergram.BMP
2103^WBC
2103 WBC Histogram.BIN WBC scattergram BMP data ED
Scattergram.BMP
DIFF 2034^DIFF
2034 DIFF scattergram BMP data ED
Scattergram.BMP Scattergram.BMP
WBCD 2104^WBCD
2104 WBCD scattergram BMP data ED
Scattergram.BMP Scattergram.BMP
How many quality control in
2079 XB_Num XB to generate a quality NM 2079^ XB_Num
control
Enumeration Type
Data Item Value
test mode 0- CBC 1- CBC+DIFF
analysis mode 0 -Whole Blood 1-Predilute
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:
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(1)Patient Sample
<SB> MSH|^~\&| XXX ||||20110310150421||ORU^R01|8|P^S|2.4|||||CHN|UTF-8 <cr>
PID||1234567890|||Wang Sanqiang|||Male<cr>
PV1|||ABC^^235689||||Doctor Wang|Zhang San|Li Si<cr>
OBR||2|12345|1001^ Count Results||20110310112251|20110310112409|||||| |20110310 112251||||0|0 <cr>
OBX|1|IS|2001^MODE||0||||||F<cr>
OBX|2|IS|2002^MODE_EX||1||||||F<cr>
OBX|3|IS|2003^Ref||0||||||F<cr>
OBX|4|IS|2004^Age||17|age|||||F<cr>
OBX|5|ST|2005^Note||note position||||||F<cr>
OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|7|NM|2008^V_BAS_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|8|NM|2009^V_NEU_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|9|NM|2010^V_EOS_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|10|NM|2011^V_LYM_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|11|NM|2012^V_MON_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|12|NM|2013^V_BAS_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|13|NM|2014^V_NEU_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|14|NM|2015^V_EOS_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|15|NM|2016^V_LYM_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|16|NM|2017^V_MON_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|17|NM|2018^V_RBC||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|18|NM|2019^V_HGB||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|19|NM|2020^V_MCV||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|20|NM|2021^V_MCH||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|21|NM|2022^V_MCHC||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|22|NM|2023^V_RDW_CV||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|23|NM|2024^V_RDW_SD||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|24|NM|2025^V_HCT||4.63|10*9/L|11.00-12.00|L|||F<cr>
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 BASE64
OBX|32|ED|2103^WBC Scattergram.BMP||……BMP binary system data change to BASE64
OBX|33|ED|2034^DIFF Scattergram.BMP||……BMP binary system data change to BASE64
OBX|34|ED|2104^WBC Scattergram.BMP||……BMP binary system data change to BASE64
<EB><CR>
(2)L-J/X QC
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<SB>MSH|^~\&| XXX ||||20110311091016||OUL^R21||P^LJ|2.4|||||CHN|TUF-8<cr>

OBR||2|123 |1002^ LJ QC||20100819 |20110217131356|||||| |||||0|0<cr>
OBX|1|IS|2006^Level||0||||||F<cr>
OBX|2|NM|2007^V_WBC||4.63||||||F<cr>
OBX|3|NM|2008^V_BAS_c||4.63||||||F<cr>
OBX|4|NM|2009^V_NEU_c||4.63||||||F<cr>
OBX|5|NM|2010^V_EOS_c||4.63||||||F<cr>
OBX|6|NM|2011^V_LYM_c||4.63||||||F<cr>
OBX|7|NM|2012^V_MON_c||4.63||||||F<cr>
OBX|8|NM|2013^V_BAS_p||4.63||||||F<cr>
OBX|9|NM|2014^V_NEU_p||4.63||||||F<cr>
OBX|10|NM|2015^V_EOS_p||4.63||||||F<cr>
OBX|11|NM|2016^V_LYM_p||4.63||||||F<cr>
OBX|12|NM|2017^V_MON_p||4.63||||||F<cr>
OBX|13|NM|2018^V_RBC||4.63||||||F<cr>
OBX|14|NM|2019^V_HGB||4.63||||||F<cr>
OBX|15|NM|2020^V_MCV||4.63||||||F<cr>
OBX|16|NM|2021^V_MCH||4.63||||||F<cr>
OBX|17|NM|2022^V_MCHC||4.63||||||F<cr>
OBX|18|NM|2023^V_RDW_CV||4.63||||||F<cr>
OBX|19|NM|2024^V_RDW_SD||4.63||||||F<cr>
OBX|20|NM|2025^V_HCT||4.63||||||F<cr>
OBX|21|NM|2026^V_PLT||4.63||||||F<cr>
OBX|22|NM|2027^V_MPV||4.63||||||F<cr>
OBX|23|NM|2028^V_PDW||4.63||||||F<cr>
OBX|24|NM|2029^V_PCT||4.63||||||F<cr>
OBX|25|NM|2030^V_P_LCR||4.63||||||F<cr>
OBX|26|ED|2031^RBC Histogram.BIN||……BIN binary system data change to BASE64 code……||||||F<cr>
OBX|27|ED|2032^PLT Histogram. BIN||……BIN binary system data change to BASE64 code……||||||F<cr>
OBX|29|ED|2035^BASO Scattergram.BMP||……BMP binary system data change to BASE64
<EB><CR>
(3)X-B QC
<SB>MSH|^~\&| XXX ||||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>
OBX|10|NM|2022^V_MCHC||4.63||||||F<cr>
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AppendixB 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:
(1)With no graph, paper can be saved
(2)With graph, the default report format.
In initial use, please save the template before modification. For the design of the template is debugged strictly,
inappropriate changes may affect the printing.
The following describes the specific function and use of the report designer.
B.1 Report Designer Object
Report designer is in the toolbar(left), a total of three objects:
Icon Name Description
TextBox Rectangular box which contain multiple lines of text. Allow contain variable text.
PictureBox Display picture format of BMP, ICO, WMF, EMF and JPG
Line Draw vertical or horizontal lines in report.
B.1.1 “TextBox”
Rectangular box which contain multiple lines of text. Type, color and width of frame, font attribute, text
alignment and font direction (vertical or horizontal) can be set. Use “Text” and “Frame” tools to set the
attribute of the object, as Figure B.1 shows:
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;
“Cancel” button;
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“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 “cture 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 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.
(1)“Standard” toolbar
(2)“Format” toolbar
(3)“Frame” toolbar
(4)“Alignment” toolbar
The use of the button is same as other software.
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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.
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
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If the “Extend to the printer” option is selected, the page form of designer will not display the border area. All
regions of the page will be printed correctly. But the size is different in different printing.
If this option is canceled, and all margin set to be 0, then the margin will be automatically set to the selected
printer's maximum print area. When designed report switch from one printer to other printer (the printable area
of ink jet printer is smaller than that of stylus printer), this function very useful.
If the margin set to be non 0, margins will be reflected in a page from of the designer (marked with gray lines).
If you use a dot matrix printer, first preview whether the print content is within the print area (some stylus
printer will not print the content beyond printing scope, and other printer prompts the beyond print scope). In
this case, set the margins manually.
B.2.4 Other
Click “Margin” in Figure B.4, as Figure B.7 shows:
Figure B.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.
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
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height or width.
Change the font: Select the object, and then select the font size or bold, italic and so on.
Undo: error happened during modification, undo operation for one or more times, the report will return back to
the style before modification.
Save: press the “Save” button after all operation is completed. Note: If it is patient sample report, please store
in the software installation directory \ Print \ Sample folder; save quality control report into \ Print \ QC folder
of software installation directory
Use: open the system setting in data management software, select the report in print setting.
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AppendixC Product Warranty

Dear customer:
Thank you for purchasing BF Series Automatic Hematology Analyzer (Model: BF-6500) of our company. We
can offer you the following service:
(1)Technique consultation is provided at any time.
(2)One year warranty from the day purchased.
(3)Paid service is provided in following condition:
a)Product out of warranty period.
b)Damage caused by accident or wrong operation.
c)Operation is not according to the manual requirement.
d)Repair the instrument without our permission.
(4)With the development of technology, we will supply the service of update of BF Series Automatic
Hematology Analyzer (Model: BF-6500).
If you need any technical support, please contact us according to the following address and telephone:
Register/Manufacturer: DIRUI INDUSTRIAL CO.,LTD.
Register/Manufacturer Address:
95 Yunhe Street, New & High Tech. Development Zone, Changchun, Jilin 130012, the People’s Republic of
China
Headquarter Address:
3333 Yiju Street, New & High Tech. Development Zone Changchun,Jilin 130103, the People’s Republic of
China
Factory Address:
95 Yunhe Street, New & High Tech. Development Zone Changchun,Jilin 130012, the People’s Republic of
China
Tel: 400 811 6695, 400 811 6605
Website: http://www.dirui.com.cn
E-mail: dirui@dirui.com.cn
For complaint: +86(431)81935326 85177245
Fax: +86(431)85173354
After-Sale Service From: DIRUI INDUSTRIAL CO.,LTD.

International customer service hotline: +86 400 808 7597
International customer service e-mail: service@dirui.com.cn
Domestic customer service hotline: 400 811 6695, 400 811 6605
Domestic fax: +86(431)85100405
Domestic customer service e-mail: service.ch@dirui.com.cn
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AppendixD Product Description

D.1 Product assortment
According to medical equipment product assortment catalogue:
Belongs to blood analyze system in clinic counting instrument (6840), type II in management type.
D.2 Accessory reagent
(1)BF-Diluent
(2)BF-FDT Lyse
(3)BF-6500 Lyse (SLS-I)
(4)BF-FDO Lyse
(5)BF Detergent
D.3 Reagent consumption
Operation must be done by instrument Consumption
Sleep (Instrument has not been used for 2 hours) Diluent 40mL
Wake up (Use instrument again; Sleep time within 3 hours) Diluent 30mL
Wake up (Use instrument again; Sleep time: 3—10 hours) Diluent 70mL
Wake up (Use instrument again; Sleep time exceeds 10 hours) Diluent 110mL
Diluent 250mL
Detergent 13mL
Manual rinse FDO Lyse 4mL
FDT Lyse 0.44mL
SLS-I Lyse 1mL
Diluent 175mL
Detergent 8mL
Automatic rinse(Set times: 10—200) FDO Lyse 3.9mL
FDT Lyse 0.44mL
SLS-I Lyse 1mL
Diluent 185mL
Detergent 5mL
Automatic rinse before sleep (Set times: 10—600) FDO Lyse 4mL
FDT Lyse 0.44mL
SLS-I Lyse 1mL
Diluent 130mL
FDO Lyse 2mL
Power on
FDT Lyse 0.22mL
SLS-I Lyse 0.5mL
Diluent 152mL
Power off
Detergent 14mL
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Rinse WBC Pool Diluent 16mL
Rinse RBC Pool Diluent 12mL
Rinse DIFF Pool Diluent 13mL
Diluent 46mL
Rinse swab
Detergent 2.2mL
Rinse Sheath Flow Pool Diluent 13mL
Clear sample loader bubbles Diluent 13mL
Remove Clog Diluent 28mL
Backflush Diluent 25mL
Diluent 110mL
Detergent 3.8mL
Soaking WBC FDO Lyse 2mL
FDT Lyse 0.24mL
SLS-I Lyse 0.5mL
Diluent 110mL
Detergent 3.8mL
Soaking RBC FDO Lyse 2mL
FDT Lyse 0.24mL
SLS-I Lyse 0.5mL
Diluent 148mL
Detergent 6mL
Soaking DIFF FDO Lyse 3.9mL
FDT Lyse 0.44mL
SLS-I Lyse 1mL

Prime FDO Lyse (After drain) FDO Lyse 10mL
Prime FDT Lyse (After drain) FDT Lyse 10mL
Prime SLS Lyse (After drain) SLS-I Lyse 10mL
Diluent 260mL
FDO Lyse 2mL
Prime Diluent (After drain)
FDT Lyse 0.24mL
SLS-I Lyse 0.5mL
Diluent 54mL
FDO Lyse 15mL
Replace FDO Lyse
FDT Lyse 0.24mL
SLS-I Lyse 0.5mL
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Diluent 52mL
FDT Lyse 13.24mL
Replace FDT Lyse
FDO Lyse 2mL
SLS-I Lyse 0.5mL
Diluent 57mL
SLS-I Lyse 13.5mL
Replace SLS-I Lyse
FDO Lyse 2mL
FDT Lyse 0.24mL
Diluent 348mL
FDO Lyse 2mL
Replace Diluent
FDT Lyse 0.24mL
SLS-I Lyse 0.5mL
Diluent 14mL
Replace Detergent
Detergent 5mL
Reagent consumption per test (no automatic rinse)

Diluent 47mL
SLS-I 0.5mL
FDO 2mL
FDT 0.22mL
D.4 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# 10 ／L

9
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Name Ab Unit
Monocyte Number MON# 109／L

Neutrophil Number NEU# 109／L
Eosinophil Number EOS# 109／L
Basophil Number BAS# 109／L
RBC Hematocrit HCT L／L
Mean RBC Hemoglobin Content MCH pg
Mean RBC Hemoglobin Concentration MCHC g／L

Platelet Hematocrit PCT %
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AppendixE Performance Index

E.1 Blank Counting of the Analyzer
(1)RBC≤0.05×1012/L;
(2)WBC≤0.5×109/L;
(3)HGB≤2g/L;
(4)PLT≤10×109/L.
E.2 Linearity
The linearity range and linearity error shall meet the requirement as shown in the table below:
Table E-2-1 Requirement of Linearity Range and Error
Parameters Linearity Range Linearity Error

(1.0-10.0)×109/L No more than ±0.5×109/L
WBC
(10.1-99.9)×109/L No more than±5%
12
(0.30-1.00)×10 /L No more than±0.05×1012/L
RBC
(1.01-7.00)×1012/L No more than±5%
(20-70) g/L No more than±2g/L
HGB
(71-240) g/L No more than±3%
9
(20-100)×10 /L No more than±10×109/L
PLT
(101-999)×109/L No more than±10%
E.3 Comparability (deviation requirements)

(1)RBC not exceed ±2.5%;
(2)WBC not exceed ±5.0%;
(3)HGB not exceed ±2.5%;
(4)PLT not exceed ±8.0%;
(5)HCT/MCV not exceed ±3.0%.
E.4 WBC Sorting Accuracy Test
The test results obtained with the specified testing method regarding neutrophils, lymphocytes, monocytes,
eosinophils, and basophils shall be within the allowable range (99% credibility interval).
E.5 Reproducibility
The reproducibility of the analyzer shall meet the requirement shown in Table E-5-1.
Table E-5-1 Reproducibility Requirement
Parameters Measuring Range Precision

9
WBC (4.0-10.0)×10 /L ≤4.0%
12
RBC (3.50-5.50)×10 /L ≤2.0%
HGB (110-160) g/L ≤2.0%
9
PLT (100-300)×10 /L ≤8.0%
(35-50)% ≤3.0%
HCT/MCV
(80-100)fL ≤3.0%
E.6 Carry-over Contamination Rate

(1)RBC≤2.0%.
(2)WBC≤3.5%.
(3)HGB≤2.0%.
E-1
User Manual
(4)PLT≤5.0%.
E-2
User Manual
AppendixF Accessories List

The accessories list includes accessories, fittings, and consumables.
Replacement
Name Position Replacement Cycle Remarks
Guide
Sampling Syringe 3000h
Sampling Pump 8.5.1
Unit (continuous working)
Sheath Liquid 3000h
Testing Pump 8.5.1
Syringe Unit (continuous working)
BF-SLS-I Syringe Four linked Syringes 3000h 8.5.1
Pump Unit (continuous working)
BF-FDO Syringe Four linked Syringes 3000h
8.5.1
BF-FDT Syringe Four linked Syringes 3000h
8.5.1
BF-Diluent Four linked Syringes 3000h
8.5.1
Syringe Pump Unit (continuous working)
Positive Pressure 3000h
Pump Unit 8.5.2
Pump (continuous working)
Inspected or replaced
Contact the
3000h (continuous by the representative
Vacuum Pump Pump Unit customer
working) from the manufacturer
service staff.
or distributor only.
Contact the
HGB Light 1000h (continuous by the representative
Count Unit customer
Source working) from the manufacturer
service staff.
Contact the
Reagent Bottle by the representative
Back of the analyzer timely customer
Assembly from the manufacturer
service staff.
Diluent Tank Cap
Back of the analyzer timely 2.3.1
Assembly
Detergent
Back of the analyzer timely 2.3.1
Assembly
F-1
User Manual
F-2

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This manual is applicable for BF Series Automatic Hematology Analyzer (Model: BF-6500),

hereinafter called “instrument”.

Date of Manufacture: refer to the label.

Use Limit: 7 years.

Configuration No.: 001.

● The instrument must be used in good grounding condition.

● It cannot be used in flammable and explosive environment.

● Avoid direct contact with the patient's blood.

● Disposable supplies cannot be reused.

The manufacturer has the final interpretation of the manual.

(2)Relevant electrical equipment is in line with the national standards.

(3)Operation is subject to the user manual.

All software interfaces are subject to change without notice.

Chapter1 Brief Introduction .....................................................................................................1-1

1.5 Instrument Structure ................................................................................................................................ 1-9

1.6 External Devices ...................................................................................................................................... 1-11

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

2.3 Installation Steps ....................................................................................................................................... 2-2

2.4 Software Uninstallation .......................................................................................................................... 2-12

3.3 Setting ......................................................................................................................................................... 3-5

Chapter4 Calibration .................................................................................................................4-1

4.3 Calibration with Calibrator ..................................................................................................................... 4-1

4.5 Manual Calibration ................................................................................................................................... 4-5

5.2 X QC ........................................................................................................................................................ 5-8

6.4 Sample Testing of Whole Blood Mode .................................................................................................... 6-3

6.5 Pre-dilution Sample Testing ..................................................................................................................... 6-8

6.6 Sleeping .................................................................................................................................................... 6-10

7.1 Record Selection ........................................................................................................................................ 7-1

7.4 CV Calculation and Tendency Graph ..................................................................................................... 7-5

7.5 Bulk Audit .................................................................................................................................................. 7-7

7.7 Delete .......................................................................................................................................................... 7-8

7.14 Backup .................................................................................................................................................... 7-13

8.2 System Status ............................................................................................................................................. 8-2

8.3 Mechanical Detect ..................................................................................................................................... 8-4

8.4 System Maintenance ................................................................................................................................. 8-4

8.4.3 Maintenance ................................................................................................................................................................ 8-9

8.5 Replacement of Wearing Components .................................................................................................. 8-15

8.6 System Log ............................................................................................................................................... 8-16

Chapter1 Brief Introduction

1.2 Working Environment

Sample barcode Identify automatically or input manually

Hemoglobin test Test hemoglobin utilizing the reagent without cyanide

Reagent barcode External barcode reader or manual input

Connect to LIS/HIS It can connect to LIS/HIS

Whole 490 mm×540 mm×550mm

Power consumption 175VA

1.4 Working Principle

Figure 1-4-1 RBC/PLT Dilution Process

(2)WBC/Hemoglobin Dilution Process

Figure 1-4-2 WBC/Hemoglobin Dilution Process

Figure 1-4-3 WBC Differential Dilution Process

Figure 1-4-4 RBC/PLT Dilution Process

Figure 1-4-5 WBC/Hemoglobin Dilution Process

(3)WBC Differential Dilution Process

Figure 1-4-6 WBC Differential Dilution Process

Figure 1-4-7 Flow Cell

Figure 1-4-8 4-diff Scattergram Drawing

Figure 1-4-9 Counting Principle Diagram

1.4.5 Hemoglobin Concentration Testing— Colorimetry

1.4.6.4 PLT Parameter

1.5 Instrument Structure

1.5.1 Front Picture

1.5.2 Rear Picture

1012/L . Default Unit