This manual is applicable for BF Series Automatic Hematology Analyzer (Model: BF-6880),

hereinafter called “instrument”.

Instructions

Dear users: Thank you for purchasing the BF Series Automatic Hematology Analyzer (Model: BF-6880).

Please read the User Manual thoroughly prior to operation so as to properly use the instrument. Improper
operation may diminish accuracy and precision of measurement or pose a danger to your personal safety.

Please maintain the User Manual properly for future use.

Date of Manufacture: refer to the label.

Use Limit: 7 years.

Version: REV. 01-2016.

Configuration No.: 001.

Warning

● Please dispose of reagents, waste solution, waste samples and consumables according to the national or local
regulations.

● Please dispose of waste solution and instrument consumables according to the regulations about medical
wastes, infective wastes and industrial wastes. Blood in wastes may have been contaminated by pathogens.

● Avoid contact with the puncture probe, because the blood, Control and Calibrator on the puncture probe
have potential bio-infectivity. When the puncture probe is aspirating a sample, there should be a certain
distance between the probe tip and the wall of the container to avoid splashing blood. Or the accuracy of
aspiration may be affected.

● Avoid direct contact with patients’ blood samples.

● Disposable supplies cannot be reused.

Caution

● The instrument should be operated by professional medical inspection specialists, or physicians, nurses or
lab assistants who are specially trained.

● The hospital or inspection bodies using the instrument should compile maintenance plans, and carry out
maintenance according to the plans. Otherwise, instrument malfunction may occur.

● The instrument must be controlled by the dedicated software. Install the software specified by our company.
The installation of other software and hardware may affect the normal operation of the system. Do not run
other software when the instrument is operating.
● For the use and storage of the reagents, refer to the reagent instructions.

● Expired reagent cannot be used. The reagent should be protected from dusts, dirt and bacteria once opened.

● Pine oil and benzene cannot be used to clean the outside of the instrument; otherwise it may cause color and
shape change. Soft cloth or gauze can be used for cleaning. Diluted detergent and alcohol can be used if
necessary.

● When the transportation or storage temperature 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.

● An independent power supply is a must. If the instrument and other electrical instruments share one power
outlet, electromagnetism interference will affect the accuracy of the test results.

● Do not pull out the electrical wire with wet hands, or there is a risk of electrical shock.

● Do not trample, twist, or drag the wire and cable, or it may cause a fire. The damaged wire and cable cannot
be used.

● The instrument must be used in good grounding condition.

● The input power should conform to the instrument requirement. Use specified fuses.

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

● It cannot be used in a flammable and explosive environment.

● Do not touch moving parts when the instrument is testing to avoid accidents.

● 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 specified conditions in the user manual. In improper conditions,
the instrument may not work well, the results may be inaccurate, instrument components 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.

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

Contents

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

1.1 Introduction ............................................................................................................................................... 1-1
1.2 Normal Working Conditions .................................................................................................................... 1-1
1.3 Specifications ............................................................................................................................................. 1-1
1.4 Working Principle ..................................................................................................................................... 1-2
1.4.1 Sample Dilution .......................................................................................................................................................... 1-2
1.4.2 Sample Aspiration ....................................................................................................................................................... 1-2
1.4.3 WBC Testing .............................................................................................................................................................. 1-4
1.4.4 WBC Parameter Calculation ....................................................................................................................................... 1-6
1.4.5 Hemoglobin Concentration Testing ............................................................................................................................ 1-7
1.4.6 RBC / PLT Testing...................................................................................................................................................... 1-7
1.4.7 Rinsing ........................................................................................................................................................................ 1-9
1.5 Structure .................................................................................................................................................... 1-9
1.5.1 Front Picture................................................................................................................................................................ 1-9
1.5.2 Rear Picture ............................................................................................................................................................... 1-10
1.5.3 Right Picture ............................................................................................................................................................. 1-10
1.6 External Devices ...................................................................................................................................... 1-10
1.7 Symbol ...................................................................................................................................................... 1-11
Chapter 2 Installation ................................................................................................................2-1
2.1 Installation Requirements ........................................................................................................................ 2-1
2.1.1 Space Requirements .................................................................................................................................................... 2-1
2.1.2 Power Requirements ................................................................................................................................................... 2-1
2.1.3 Environmental Requirements ...................................................................................................................................... 2-1
2.2 Unpacking .................................................................................................................................................. 2-1
2.2.1Unpacking Procedures ................................................................................................................................................. 2-1
2.2.2 Transportation Method ................................................................................................................................................ 2-2
2.3 Instrument Installation ............................................................................................................................. 2-2
2.3.1 Hardware Installation .................................................................................................................................................. 2-2
2.3.2 Software Installation ................................................................................................................................................... 2-5
2.4 Software Uninstallation .......................................................................................................................... 2-13
2.5 Software Login ........................................................................................................................................ 2-13
2.5.1 Login Software .......................................................................................................................................................... 2-13
2.5.2 Counting Interface..................................................................................................................................................... 2-16
2.5.3 Log Off ..................................................................................................................................................................... 2-18
2.5.4 Exit ............................................................................................................................................................................ 2-18
Chapter 3 Setting ........................................................................................................................3-1
3.1 Introduction ............................................................................................................................................... 3-1
3.2 Sample Information .................................................................................................................................. 3-1
3.3 Data Browse ............................................................................................................................................... 3-2
3.3.1 Edit Patient Information .............................................................................................................................................. 3-3
3.4 Setting ......................................................................................................................................................... 3-8
3.4.1 Normal User ................................................................................................................................................................ 3-8
3.4.2 Administrator User .................................................................................................................................................... 3-14
Chapter 4 Calibration ................................................................................................................4-1
4.1 Introduction ............................................................................................................................................... 4-1

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4.2 Calibration Requirements......................................................................................................................... 4-1

4.2.1 Calibration Frequency ................................................................................................................................................. 4-1
4.2.2 Preparation before Calibration..................................................................................................................................... 4-1
4.3 Calibration Method ................................................................................................................................... 4-1
4.3.1 Calibration with Calibrator .......................................................................................................................................... 4-1
4.3.2 Fresh Blood Calibration .............................................................................................................................................. 4-4
4.3.3 Manual Calibration ...................................................................................................................................................... 4-7
4.4 Calibration History.................................................................................................................................... 4-7
Chapter 5 Quality Control ........................................................................................................ 5-1
5.1 Introduction ............................................................................................................................................... 5-1
5.2 QC Method ................................................................................................................................................. 5-1
5.2.1 L-J QC ......................................................................................................................................................................... 5-1
5.2.2 x QC .......................................................................................................................................................................... 5-11
5.2.3 X-B QC ..................................................................................................................................................................... 5-11
Chapter 6 Normal Operation .................................................................................................... 6-1
6.1 Introduction ............................................................................................................................................... 6-1
6.2 Preparation before Operation .................................................................................................................. 6-1
6.3 Daily QC ..................................................................................................................................................... 6-1
6.4 Sample Preparation ................................................................................................................................... 6-1
6.4.1 Whole Blood Sample Preparation ............................................................................................................................... 6-1
6.4.2 Add Diluent ................................................................................................................................................................. 6-2
6.5 Sample Testing of Close-Whole Blood Mode .......................................................................................... 6-4
6.5.1 Sample Information Edition ........................................................................................................................................ 6-4
6.5.2 Sample Analysis Procedures ....................................................................................................................................... 6-4
6.5.3 Picture Check .............................................................................................................................................................. 6-7
6.5.4 Research Parameter Check .......................................................................................................................................... 6-7
6.5.5 Research Parameter Print ............................................................................................................................................ 6-8
6.6 Close-Prediluted Sample Testing ............................................................................................................. 6-8
6.6.1 Working Mode Checking ............................................................................................................................................ 6-8
6.6.2 Sample Analysis .......................................................................................................................................................... 6-9
6.7 Auto-Whole Blood Mode......................................................................................................................... 6-10
6.7.1 Barcode and Paste Requirement ................................................................................................................................ 6-10
6.7.2 Sample Information Edition ...................................................................................................................................... 6-10
6.7.3 Analysis Mode and Sample No. Setting .................................................................................................................... 6-11
6.7.4 Sample Analysis Procedures ..................................................................................................................................... 6-12
6.7.5 Picture Check ............................................................................................................................................................ 6-13
6.7.6 Research Parameter Check ........................................................................................................................................ 6-13
6.8 Emergency Sample Analysis ................................................................................................................... 6-14
6.9 Parameter Alarm ..................................................................................................................................... 6-16
6.9.1 Parameter Alarm Types ............................................................................................................................................. 6-16
6.9.2 Differential or Abnormal Form Alarm ...................................................................................................................... 6-16
6.10 Sleeping ................................................................................................................................................... 6-17
6.11 Rinse and Clog Removal ....................................................................................................................... 6-17
6.12 Shutdown ................................................................................................................................................ 6-17
6.12.1 Instrument Shutdown .............................................................................................................................................. 6-18
6.12.2 Software Exit ........................................................................................................................................................... 6-18
Chapter 7 Record Query ........................................................................................................... 7-1
7.1 Introduction ............................................................................................................................................... 7-1

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7.2 Record Selection ........................................................................................................................................ 7-1

7.3 Print ............................................................................................................................................................ 7-2
7.3.1 Single Sample Printing ................................................................................................................................................ 7-2
7.3.2 Bulk Print .................................................................................................................................................................... 7-2
7.4 Query .......................................................................................................................................................... 7-3
7.4.1 Query According to Sample No. ................................................................................................................................. 7-4
7.4.2 Query According to ID Number .................................................................................................................................. 7-4
7.4.3 Query According to Test Mode and Date .................................................................................................................... 7-4
7.4.4 Query According to Case No. ..................................................................................................................................... 7-5
7.4.5 Query According to Bed No........................................................................................................................................ 7-5
7.4.6 Query According to Name and Sex ............................................................................................................................. 7-5
7.4.7 Query According to Department and Deliver Doctor .................................................................................................. 7-5
7.4.8 Query According to Auditor ....................................................................................................................................... 7-5
7.4.9 Query According to Tester .......................................................................................................................................... 7-5
7.5 CV Calculation and Trend Chart ............................................................................................................ 7-5
7.5.1 CV Calculation............................................................................................................................................................ 7-5
7.5.2 Trend Chart ................................................................................................................................................................. 7-6
7.6 Bulk Audit .................................................................................................................................................. 7-7
7.7 Communication ......................................................................................................................................... 7-8
7.7.1 Communication Interface ............................................................................................................................................ 7-8
7.7.2 Sample Application ..................................................................................................................................................... 7-9
7.8 Delete .......................................................................................................................................................... 7-9
7.9 Export ......................................................................................................................................................... 7-9
7.10 Sample Addition .................................................................................................................................... 7-10
7.11 Patient Information Modification ........................................................................................................ 7-10
7.12 Recheck .................................................................................................................................................. 7-10
7.13 Chart Query ........................................................................................................................................... 7-11
7.14 Review Compare ................................................................................................................................... 7-11
7.14.1 Parameter Setting .................................................................................................................................................... 7-12
7.14.2 Compare List ........................................................................................................................................................... 7-13
7.14.3 Tendency ................................................................................................................................................................. 7-14
7.15 Data Backup .......................................................................................................................................... 7-15
7.16 Data Recovery........................................................................................................................................ 7-16
7.17 Help......................................................................................................................................................... 7-17
Chapter 8 Service .......................................................................................................................8-1
8.1 Introduction ............................................................................................................................................... 8-1
8.2 Maintenance Guide ................................................................................................................................... 8-1
8.2.1 Regular Maintenance .................................................................................................................................................. 8-1
8.2.2 Maintenance in Need................................................................................................................................................... 8-2
8.3 System Status ............................................................................................................................................. 8-2
8.3.1 System Version ........................................................................................................................................................... 8-2
8.3.2 Basic Status ................................................................................................................................................................. 8-3
8.4 Mechanical Detect ..................................................................................................................................... 8-4
8.4.1 Motor Detect ............................................................................................................................................................... 8-4
8.4.2 Valve Detection........................................................................................................................................................... 8-4
8.4.3 Pump Detection ........................................................................................................................................................... 8-4
8.5 System Maintenance ................................................................................................................................. 8-4
8.5.1 Replacement/Priming .................................................................................................................................................. 8-4
8.5.2 Rinsing ........................................................................................................................................................................ 8-7

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8.5.3 Maintenance ................................................................................................................................................................ 8-9

8.5.4 Reagent Registration ................................................................................................................................................. 8-15
8.6 Replacement of Wearing Components .................................................................................................. 8-16
8.6.1 Replace Syringe Pump .............................................................................................................................................. 8-16
8.6.2 Replacement of puncture probe ................................................................................................................................. 8-17
8.7 System Log ............................................................................................................................................... 8-18
Chapter 9 Failure Handling ...................................................................................................... 9-1
9.1 Introduction ............................................................................................................................................... 9-1
9.2 Failure Information and Solution. ........................................................................................................... 9-1
Chapter 10 Transportation and Storage................................................................................ 10-1
10.1 Transportation ....................................................................................................................................... 10-1
10.2 Storage .................................................................................................................................................... 10-1
Appendix A Network Communication Interface Protocol V1.1 ........................................... A-1
Appendix B Report Designer User Guide ............................................................................... B-1
Appendix C Manufacturer’s Warranty .................................................................................. C-1
Appendix D Product Description ............................................................................................ D-1
Appendix E Performance Index .............................................................................................. E-1
Appendix F Accessories List .................................................................................................... F-1

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Chapter 1 Brief Introduction

1.1 Introduction
BF Series Automatic Hematology Analyzer (Model: BF-6880) 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 25 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 Normal Working Conditions

(1)Input Voltage: 100V-240V~, 50/60Hz;
(2)Environment Temperature:18℃~30℃;
(3)Relative Humidity: no more than 75%;
(4)Atmosphere Pressure: 75kPa~106kPa;
(5)Above-sea-level Height: no more than 2000m ;
(6)Protect from frost, dew, seepage, rain, sunlight, etc.

1.3 Specifications
Model
Specifications
BF-6880
WBC, BAS#, NEU#, EOS#, LYM#, MON#, BAS%, NEU%, EOS%,
Test Item LYM%, MON%, RBC, HGB, MCV, MCH, MCHC, RDW-CV,
RDW-SD, HCT, PLT, MPV, PDW, PCT, P-LCR, P-LCC
Carry out five-part differential to WBC counting result; the instrument
Parameters can test 25 parameters, offer 1 scattergram and 4 histograms; it will alarm
Basic when the abnormal condition of pathology and morphology occurs
Features Throughput 80T/H
Sample Feeding Method Manual or automatic sample feeding.
Storage 100000 results (maximum)
Sample Barcode Automatic identification or manually input.
Reagent Type Four types in total, including diluent and 3 types of Lyses

Reagent Hemoglobin Test Test hemoglobin utilizing the reagent without cyanide
System Alarm Alarms 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 Principle analysis method
System Utilizes impedance technology for WBC, RBC, PLT counting;
Counting Method
colorimetric method for HGB counting.
Data Interface RJ45
System Connect to LIS/HIS Can be connected to LIS/HIS
Weight 60kg
Whole
instrument Dimensions 606mm×690mm×550mm(L×W×H)
system
Power 175VA

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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 result of other parameters are calculated upon the above
results.
1.4.1 Sample Dilution
The sample is divided into 2 parts after sample aspiration. And the sample will be dispensed into WBC
differential detector, WBC counting cell and RBC counting cell in order according to the test requirement.
Through the effects of different reagents while dilution process, forming samples which are used for WBC
differential testing, WBC/ hemoglobin testing and RBC/PLT testing.
For different sample, the instrument offers two different working modes - whole blood mode and pre-dilution
(Peripheral Blood) mode.
1.4.2 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 80μL
(CBC+DIFF mode) or 40μL (CBC mode) diluted sample.
1.4.2.1 Whole Blood Mode
(1)RBC/PLT Dilution Process

Figure 1-4-1 RBC/PLT Dilution Process

(2)WBC/Hemoglobin Dilution Process

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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

Figure 1-4-4 RBC/PLT Dilution Process

(2)WBC/Hemoglobin Dilution Process

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Figure 1-4-5 WBC/Hemoglobin Dilution Process

(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 —Lymphocytes, Monocytes, Eosinophils and Neutrophils
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:

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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:

Figure 1-4-8 4-diff Scattergram Drawing

The lymphocytes, monocytes, eosinophils and neutrophils percentage can be obtained from the DIFF channel
scattergram.
1.4.3.2 Impedance Method—WBC Number/Basophil
WBC number and basophils are counted through impedance method. The aspirated sample is dispensed into
test unit after diluted by quantitative conducting solution. The testing unit has a test aperture. A pair of positive
and negative electrodes exist beside the aperture for connecting the constant current power supply. As the cells
have the characteristic of a poor conductor, when the cell goes through the aperture under constant negative
pressure, the DC resistance between the electrodes will change, resulting in the formation of a pulse signal
which is proportional to the cell size. A series of electrical pulse is produced when the cell continuously go
through the aperture. The number of pulses is equivalent to the cell number through the aperture. The pulse
amplitude is proportional to the cell size.

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Figure 1-4-9 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 Calculation
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.
1.4.4.1 WBC
WBC number can be obtained through testing the corresponding pulse number.
1.4.4.2 Basophil
Basophil number can be obtained through testing the corresponding pulse number.
1.4.4.3 Basophil Percentage
BAS#
BAS%= × 100%
WBC
1.4.4.4 Lymphocyte Percentage
The number of cells LYM area of Diff channel
LYM% = × 100%
The number of all cells in Diff channel except ghost

1.4.4.5 Neutrophil Percentage

The number of cells NEU area of Diff channel
NEU% = × 100%
The number of all cells in Diff channel except ghost

1.4.4.6 Monocyte Percentage

The number of cells MON area of Diff channel
MON% = × 100%
The number of all cells in Diff channel except ghost

1.4.4.7 Eosinophil Percentage

The number of cells EOS area of Diff channel
EOS% = × 100%
The number of all cells in Diff channel except ghost

1.4.4.8 Lymphocytes
LYM # = WBC × LYM%
1.4.4.9 Neutrophil
NEU # = WBC × NEU%

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1.4.4.10 Monocyte
MON # = WBC × MON%
1.4.4.11 Eosinophil
EOS# = WBC × EOS%

1.4.5 Hemoglobin Concentration Testing

SLS-hemoglobin method combines 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 (as Figure 1-4-9). RBC
/ platelet sample flow into RBC test unit after twice dilution. The testing unit has a test aperture. A pair of
positive and negative electrodes exist beside the aperture. As the cells have the characteristic of a poor
conductor, when the cell go through the aperture under constant negative pressure, the DC resistance between
the electrodes will change, resulting in the formation of a pulse signal which is proportional to the cell size. A
series of electrical pulse is produced when the cell continuously go through the aperture. The number of pulses
is equivalent to the cell number through the aperture. The pulse amplitude is proportional to the cell size.
Compare the amplified electric pulse with channel voltage value corresponding to normal RBC/PLT size range.
Calculate the electrical pulse number. All electrical pulse is classified according to different channel voltage
value. Electrical pulse number which fell in RBC/PLT channel is RBC/PLT number. Cell number in each
channel which is divided according to pulse voltage range determines the cell size distribution. The
two-dimensional map with cell size as abscissa and cell number as vertical axis is the histogram reflects the
distribution of cell.
1.4.6.2 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 × 1012 / L
(2)Mean RBC Volume
Calculate mean RBC volume (MCV) 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

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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.
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 × 109 / 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)PLT Ratio(P-LCR)
PLT Ratio is obtained through PLT histogram.
(6)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.

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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 puncture probe should be rinsed with diluent;
(2)Counting pool should be rinsed with diluent;
(3)Flow cell should be rinsed with diluent.

1.5 Structure
BF Series Automatic Hematology Analyzer is composed of mechanical motion, pipeline, optical, electronic
control, software, etc.
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:
1.5.1 Front Picture

1 Front Door 2 Indicator (yellow: alarm indicator, green: running status indicator, red: power indicator from left to right)
3 STAT Key 4 Sample Loader 5 Emergency Rack 6 Tube Rack 7 Mode Key 8 Count Key
Figure 1-5-1 Front Picture

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1.5.2 Rear Picture

1 Upper Cover 2 Right Door Assembly 3 Fan 4 Back Cover 5 Fan 6 Fan 7 Waste Liquid Inlet
8 Diluent Inlet 9 FDT Lyse Inlet 10 FDO Lyse Inlet 11 SLS-I Lyse Inlet 12 Detergent
13 Left Door Assembly
Figure 1-5-2 Rear Picture

1.5.3 Right Picture

1 Power Switch 2 Power Socket 3 Sensor Port 4 Net Port(RJ45)

Figure 1-5-3

1.6 External Devices

Printer: Connected with computer. The report can be printed through computer.
Barcode Reader: Connected with host computer to input barcode information.

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1.7 Symbol

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

Do not touch the puncture probe when the instrument is running.

“ON”(POWER)

“OFF”(POWER)

The above symbols are included on the instrument, reagents, Controls and Calibrators.

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Chapter 2 Installation

● To ensure the normal working of the instrument after installation, the initial installation of the
instrument should be carried out by authorized professionals of the manufacturer.
● Dedicated computer software should be used for controlling. It is recommended that the software and
database should not be installed in the system disk.

2.1 Installation Requirements

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 60kg.
2.1.1 Space Requirements
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.
2.1.2 Power Requirements
(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.
Good grounding is a must.
2.1.3 Environmental Requirements
(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 sources, and protected from sunlight.
(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 requirements. Or cause
instrument damage and endanger personal safety.

2.2 Unpacking
2.2.1Unpacking Procedures
After receiving the instrument, check whether there is physical damage onto the packaging case. Contact the

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manufacturer or the local distributor if any damage is found. Open the case if no external damage is found
according to the following steps:
(1)Place the package in the direction of the arrow upward.
(2)Open the instrument and accessory case, and check the items according to the packing list. Contact The
manufacturer or the local distributor if anything is missing.
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 puncture 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 Instrument Installation

The instrument should not be disassembled except for 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 Instrument and Reagent Connection
(1)Connection of Detergent, Lyse, Diluent, and Waste Solution
Put the bottles of FDT Lyse, FDO Lyse, SLS-I Lyse and Detergent at the back of the instrument. Connect
them according to Figure 2-3-1. Put the diluents barrel and waste liquid barrel under the working table.
Connect according to Figure 2-3-1.
(2)Connection of Liquid Level Sensor
Connect the other end of the accompanying liquid level sensor to the sensor port on the right side plate of the
instrument. Connect the liquid level sensor to the corresponding reagent bottle, diluent and waste liquid barrel,
according to the marks on the lead.

● Waste liquid should be disposed of according to local regulations.

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● The water discharge system should conform to the waste water disposal requirements for local
medical institutions.
(3)Computer Connection
Connect the “Net Port” of the computer to “RJ45” on the right side plate of the instrument.
(4)Power Cable Connection
Connect one end of the accompanying power cable to the plug on the right side of the instrument. And connect
the power cable of the computer main case, 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 Connection
Insert one end of the barcode reader into the “USB” of the computer main case.

The light beam of the barcode reader may hurt eyes; therefore, do not stare at it.
(6)Printer Connection
Connect the printer and the computer through a data cable, and check
a)whether the printer driver is installed.
b)the specifications of the printing paper.

During transportation, to avoid damaging puncture probes and mechanical arms, use screws, fixing
frames and nylon ties to fix the moving parts when leaving the factory. The screws, fixing frames, and
nylon ties must be taken down before power on, or it may cause damage to puncture probes and
mechanical arms. The positions for screws, frames and nylon ties are shown below:

Screw 1

Figure 2-3-2

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Fixing frame
Screw 2, 3

Figure 2-3-3

Screw 4

Figure 2-3-4

Tie

Figure 2-3-5

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Screw 1, 2, 3 and 4, the frame, and the nylon tie of the mechanical arm must be removed before power on.
Otherwise, it may cause damage to the puncture probe and mechanical arm.
2.3.2 Software Installation
The software has been installed before the instrument leaves the factory. The user should not uninstall the
software except when abnormity occurs. In case of a necessary un-installation, please follow the following
steps.
2.3.2.1 Operating System: Windows 7
Start “SetDoNet” 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:

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:

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Figure 2-3-8
Click “Next” in the following pages until the page – Figure 2-3-9 shows:

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:

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Figure 2-3-10
VC++ installation completes, as Figure 2-3-11 shows:

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

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When the above progress is finished, run upper computer installation program, the setup wizard will pop up, as
Figure 2-3-13 shows:

Figure 2-3-13
Click “Next” in the above figure, and select the installation path. The default path is C:\Program Files\, (It is
suggested 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 the above figure, the “Confirm” interface will pop up, as Figure 2-3-15 shows:

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Figure 2-3-15
Click “Next” in the above figure, the “Installing” interface will pop up, as Figure 2-3-16 shows:

Figure 2-3-16
Click “Next” after the progress is finished, and Figure 2-3-17 will pop up:

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Figure 2-3-17
Click “Close” in the above figure to finish the installation of the software. The shortcut of the program will be
displayed on the table after the installation.
If the upper computer is installed in the C:\, it is needed to modify the properties of the installation directory. If
the upper computer is installed in the other disks, the properties do not need to be modified. Details are shown
as follows:
Right-click the installation directory, and select properties, as the following figure shows:

Figure 2-3-18
Click “Security” button in the above figure, and the following figure pops up:

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Figure 2-3-19
Click “Edit…” button in the above figure, and the following figure pops up:

Figure 2-3-20
Click “Users ...” in the above figure, and add the “Full Control” permission, that is to say, tick “Allow” in the
“Full Control” line under “Permissions for Users”, as the following figure shows:

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Figure 2-3-21
Then click “Apply”, “OK” button to save the setting.
2.3.2.2 Set the Computer
(1)IP Setup
Click【Start】→ 【Control Panel】→ 【Network and Sharing Center】, then select 【Change adapter settings】
from the left column, choose 【Local Area Connection】 and click 【Properties】, and then double-click
【Internet Protocol Version 4(TCP/IPv4) 】. Refer to the figure below:

Figure 2-3-22
The undefined number “XXX” in IP Address “172.16.100.XXX” includes, but is not limited to, the number
that the above figure shows. You can input any number between【1~ 225】except 138.

The instrument’s IP address is 172.16.100.138.

(2)Set the Computer Sleep Time
Click 【Start】→【Control Panel】→【 Hardware and Sound】→【Power Options】, then select【Change

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when the computer sleeps】from the left column, and set【Never】 for when to “Put the computer to sleep”.
Refer to the figure below:

Figure 2-3-23

2.4 Software Uninstallation

If the instrument application software needs to be deleted from the current computer, click “Start”, find
“Automatic Hematology Analyzer” from programs, and click “Uninstall Automatic Hematology Analyzer”,
the “confirm” window will pop up, as Figure 2-4-1 shows:

Figure 2-4-1

Click “ ” to finish the un-installation.

2.5 Software Login

Turn on the power switch of the instrument first, and then log in the application software.
2.5.1 Login Software

Double-click the instrument application software icon on the desktop, or click “Start”, find the
software from “Program” window and single-click it to enter the “System Login” window, as Figure 2-5-1 and
Figure 2-5-2 show:

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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.

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Figure 2-5-4

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 test three times and background result is 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
Public Info. Area

2.5.2 Counting Interface

2.5.2.1 Main Menu
(1)Test: For sample information input, sample test mode selection, test records query.
(2)QC: L-J/Xbar and X-B QC.
(3)Calibration: Conducting calibration upon the instrument.
(4)Setting: Set the instrument parameters.
(5)Service: Test the status, maintain and detect the instrument.
(6)Log: Keep the operation records.
(7)Window: Display activated windows.
(8)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:

Username Failure Info. X-B Status Info. Area

Auto rinse Sample No. Sample Info. Running Status 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 the following figure 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)Sample Status: Display the analysis mode and test mode.
Analysis Mode: There are four modes. Auto-Whole Blood, Microscale-Whole Blood (No.2 position) or Close
-Whole Blood (No.3 position), Close-Prediluted (No.4 position).
Test Mode: There are two modes. “CBC” and “CBC+DIFF”.
(4)Test Status: Indicates the test status.
(5)Rinse Times: 22 in 22/200 indicating the tested sample number from the last time rinsing. 200 represents
the rinsing interval (set in Auto clean Settings).

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2.5.3 Log Off

Click in Figure 2-5-7 to log off, or switch users.

2.5.4 Exit

Click in Figure 2-5-7 to enter the “exit” window, as the following figure shows:

Figure 2-5-10

Click in the above figure to exit. Click to return to the interface continue tests.

● 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 “Setting” after login for next login.

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Chapter 3 Setting

3.1 Introduction
The system parameters of the instrument have 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.

3.2 Sample Information

Turn on the instrument, log in the software, and enter the count interface. Click in Figure 2-5-7, and
the sample information interface will pop up as the figure shows below:

Figure 3-2-1
Analysis Mode: There are four modes. Microscale-Whole Blood mode and Close-prediluted mode are manual
modes. Auto Whole Blood mode is an automatic analysis mode.
Equalize pressure automatically: It will equalize the pressure in the vacuum tube and the atmospheric pressure.
If “Equalize pressure automatically” is not clicked, there is pressure in the vacuum tube, the aspirated volume
may be not accurate, which may affect the accuracy of the test result.
Test Mode: There are two modes. “CBC” conducts counting without diff upon WBC. The counting results
include RBC, PLT histograms and other parameters. “CBC+DIFF” conducts counting and 5-differential upon
WBC, includes 25 parameters, 1 scattergram, and 4 histograms.
Tube Rack No.: When the auto-whole blood mode is selected and “Identify tube rack automatically” is not
selected, the Rack No. and Tube No. are in the available status, as Figure 3-2-2 shows:

Figure 3-2-2
Input the new rack No. and tube No. in the input box of rack No. and tube No.
Close counting mode: When close-whole blood or close-prediluted is selected, close counting method can be

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selected, as Figure 3-2-3 shows:

Figure 3-2-3
Sample No.: The sample number input in this box is the next tested sample. If the entered number repeats a
number of the intraday sample database, the following figure will pop up:

Figure 3-2-4

● Only under the analysis mode of “auto whole blood” and “close-whole blood (No.3 position)” have the
function of auto balance pressure.
● When entering a sample number, “-” can be entered. “.” cannot be entered. (“Sample No. Error” will
be prompted if there is “.”).
● The entered number of the sample that is to be tested cannot repeat the number of an already tested
or edited sample within the day.
● Reference Range: Click the pull-down menu of “Reference”, general, man, woman, child, newborn
and user-defined can be selected.

3.3 Data Browse

In Figure 3-3-1, if the lock button of the interface is in the “ ” status, patient information can be edited
or modified.

Figure 3-3-1

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3.3.1 Edit Patient Information

Click in Figure 3-3-1 to set the input items of patient information, as Figure 3-2-2 shows:

Figure 3-3-2
(1)Default Value: This value is default when editing other sample information.

(2)Remember: If , the last edited sample information will be remembered when editing other
information.

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

(4)If “Default Value”, “Remember” and “Ignore” do not need to be set, click , the previous three
items will be disabled.
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
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 number in Figure 3-3-2 automatically. Patient information can be edited.
3.3.1.1 Sample Information
(1)Sample No.: Set the next sample No. manually.
(2)Barcode No.: Can be input manually or by scanning.
(3)Reference: Double-click the input box behind “Reference” in Figure 3-3-2, the following box will pop up:

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Figure 3-3-3
Input the corresponding mnemonic in the input box of “System Code Selection”, or click the line of the
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”s. 10 options in total.
Or click the pull-down menu after “Reference”. Make selection from the popping-up figure:

Figure 3-3-4
(4)Sampling Time; Delivery Time: Select “Current Time” or “Blank” from the drop-down list of “Sample
Time” and “Deliver Time” in Figure 3-3-2. If “Current Time” is selected, click the corresponding time; manual
input is also available.
3.3.1.2 Patient Information
(1)Case No.: Input the case number in Figure 3-3-2.
(2)Name: Input the patient name in Figure 3-3-2
(3)Sex: Double-click the input box behind “Sex” in Figure 3-2-2, the following box will pop up:

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Figure 3-3-5
Input the corresponding mnemonic in the input box of “System Code Selection”, or click the line of the
corresponding item(“Setting” of main menu→ “Information” to set the commonly used ID). Click .
Or click the pull-down menu behind “Sex”, and make selection from the popping-up figure:

Figure 3-3-6
(4)Age: Input the patient age and double-click the input box of the age unit. The following box will pop up:

Figure 3-3-7
Input the corresponding mnemonic in the input box of “System Code Selection”, or click the line of the
corresponding item (“Setting” of main menu→ “Information” to set the commonly used ID). Click .
Or click the pull-down menu behind “Age Unit”, and make selection from the popping-up figure:

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Figure 3-3-8
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,

Only round numbers are allowed to be entered for the age. “.” cannot be centered.
(5)Cost Category: Enter the name of a cost category in the “Cost Category” box. Double-click the “Cost
Category” input box, and the following figure pops up:

Figure 3-3-9
Input the corresponding mnemonic in the input box of “System Code Selection”, or click the line of the
corresponding item (“Setting” of main menu→ “Information” to set the commonly used ID). Click .
Or click the pull-down menu behind “Cost Category”, and make selection from the popping-up figure:

Figure 3-3-10
(6)Department: Input the department name in the department box. Double-click “Department” input box, and
the following box will pop up:

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Figure 3-3-11
Input the corresponding mnemonic 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 .
Or click the pull-down menu behind “Dept.”, and make selection from the popping-up figure:

Figure 3-3-12
(7)Bed No.: Click the input box of “Bed No.” in Figure 3-2-2 and enter a bed number directly.
(8)Delivery Doctor: Input the name of a delivery doctor directly or double-click the input box, and the
following figure will pop up:

Figure 3-3-13
Input the corresponding mnemonic 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 .
Or click the pull-down menu behind “Dept.”, and make selection from the popping-up figure:

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Figure 3-3-14
(9)Remarks: Clinical diagnostic information after tests can be entered (can be input directly).
Click after finishing entering all the above information. When entering information, items for
which “Ignore” has been selected can be skipped. Click or to enter patient
information of other samples.

3.4 Setting
3.4.1 Normal User
Click “Setting” in the main menu to enter the setting interface, as Figure 3-4-1 shows:

Figure 3-4-1
3.4.1.1 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:

Figure 3-4-2

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.).

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3.4.1.2 Language Setting

Click “Language Setting” in Figure 3-4-1, and the following figure pops up:

Figure 3-4-3

Click the pull-down menu behind “Select Language”, select the language, click , the tip “Saving
Succeed” will pop up, click to finish the language setting.
3.4.1.3 User Setting
Click “User Settings” in Figure 3-4-3, as Figure 3-4-4 shows:

Figure 3-4-4

Only the password can be modified when the user logs in as a general user. Click in Figure
3-4-4, and Figure 3-4-5 pops up:

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Figure 3-4-5
Input a new password and the old password in the above figure (enter the same new password twice), and click
to finish the modification.

User edition, addition and deletion cannot be conducted when the user logins as a general user.
3.4.1.4 Reagent Validity Setting
Single-click “Reagent Validity Setting” in Figure 3-4-4, as Figure 3-4-6 shows:

Figure 3-4-6
Click the pull-down menu of the corresponding item, select the validity according to the reagent instructions,
and 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.

● Reagent validity should be set again before the first-time use of the instrument, or after reagent,
diluent replacement.
● Expired reagent, diluent cannot be used. Otherwise, test accuracy will be affected.
3.4.1.5 QC Setting
Click “QC Setting” in Figure 3-4-6, as the following figure shows:

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Figure 3-4-7

Figure 3-4-8
Control method, calculation method and range of L-J/X-bar QC can be selected from Figure 3-4-7.
ON/OFF and sample No./group of X-B QC can be set in Figure 3-4-8.
3.4.1.6 Print Setting
Click “Print Setting” in Figure 3-4-8. Printer name, page header icon, title and format of sample and QC can
be set in Figure 3-4-9.

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Figure 3-4-9
(1)Printer: Select a printer from its drop-down list.
(2)Report Default Icon: Report page header icon can be set. Click , and the dialog box of a
picture path will pop up. Select a picture (picture size is 34*34; format can be BMP and JPG).
Click to clear the page header icon. The icon will not be displayed in report preview.
(3)Sample: Headline, page footer and print report format can be input in this unit.
Headline: Delete the original headline and input new headline if headline need to be changed.
Page Footer: The page footer is user-defined, e.g. “This report is only responsible for the delivered sample.”
Print Report Format: Select the format in its drop-down list. Click to preview the format.
(4)QC: The headline and print report format can be input in this unit.
Headline: Delete the original headline and input new headline to change it.
Print Report Format: Select the print format in its pull-down menu, and click to preview the
format.
(5)Report Designer: User can design report format.
Refer to “Appendix B” for use.
(6)Print Research Parameter: when “Print Research Parameter” is ticked, “Input microscopic examination
result” will display in the interface, as following figure shows:

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Figure 3-4-10
(7)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.
3.4.1.7 Clogged aperture re-test switch
Click “Clogged aperture re-test switch” in Figure 3-4-10, as the following figure shows:

Figure 3-4-11

Select or , then click , as the following figure shows:

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Figure 3-4-12

Click , then click at the lower right corner to exit the setting interface.
If is selected, the instrument will re-test automatically when the aperture is clogged in the process of
test. If is selected, the instrument will alarm “The aperture is clogged, remove the clog or rinse the
aperture.” when the aperture is clogged in the process of test.
3.4.1.8 Automatic sleep time
Click “Automatic sleep time” in Figure 3-4-11, the automatic sleep time of the instrument can be set, the range
is [10, 120], as Figure 3-4-13 shows:

Figure 3-4-13

3.4.2 Administrator User

Input administrator username and password when login (Figure 2-5-2), click “Setting”, as Figure 3-4-14 shows,
the administrator can set the following items besides general 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 3-4-14
3.4.2.1 User Setting
Click “User Setting” in Figure 3-4-14, as Figure 3-4-15 shows:

Figure 3-4-15
(1)Add User:
Click in Figure 3-4-15, and the following figure pops up:

Figure 3-4-16

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Input the user name needing to be added in the input box behind “Username”. To grant the audit permission to
the new user, put a tick in the “Audit Permission” box. To grant the new user the admin permission, tick the
“Admin Permissions” box. Click to finish the user adding.
Click after username input if this user does not need audit permission or admin permission.

● The initial password of the new user is “1”, which can be modified after login.
● The name of a new user cannot be blank or the same as others.
(2)Delete User:
Click the line of general user except admin in Figure 3-4-15, the selected line will turn blue, the interface is
like 3-4-17:

Figure 3-4-17

Click in the above Figure, and the following prompt will pop up:

Figure 3-4-18

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

(3)Edit User:
Click the line of general user except admin in Figure 3-4-17, click , the interface is like 3-4-19:

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Figure 3-4-19
The audit permission of a user can be edited again. Tick the check box in front of “Audit Permission” to grant
the permission to the user. Deselect the box and the user does not have the audit permission. The administrator
permission of a user can be edited. Select the “Admin Permissions” box to grant the administrator permission.
Deselect the box and the user becomes a general user.
(4)Modify Password:
The password of the administrator and general user can be modified by administrator.
Click the line needs to be modified in Figure 3-4-17, click , the interface is as follows:

Figure 3-4-20

Input the new password twice, and press to finish the operation.
3.4.2.2 Net Setting
Click “Net Setting” in Figure 3-4-17, and select “Device Setting” from the expansion menu, as Figure
3-4-21shows:

Figure 3-4-21
The IP of the instrument is displayed but cannot be modified by the user.
LIS Setting: Select “LIS Setting” from Figure 3-4-21, as Figure 3-4-22 shows:

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Figure 3-4-22
IP address and port of LIS computer can be set. ON/OFF status of auto-communication can be selected.
The user can select whether to transmit results (On/Off) if the aperture is clogged.
3.4.2.3 Unit Setting
Click “Unit Setting” in Figure 3-4-22, as Figure 3-4-23 shows:

Figure 3-4-23

Single-click the input boxes 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 succeed” indicates successful setting.
The units are as follow:

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Table 3-4-1

Parameter Unit Value Form Remark

109/L ***.** Default Unit

103/μL ***.**
WBC
2
10 /μL ****.*

/nL ***.**

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

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

12
10 /L **.** Default Unit

106/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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3.4.2.4 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 3-4-23, as Figure 3-4-24 shows:

Figure 3-4-24
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 succeed” to finish the saving.
The following box will pop up if the input lower limit is more than the upper limit, or the input reference is not
within the set range.

Figure 3-4-25
Input again after checking if the above box is prompted.
Click “Default” to restore the setting when the reference has been modified accidentally. “Default value setting
succeed” indicates successful setting.

Figure 3-4-26
3.4.2.5 Information Setting
(1)Department Information Setting:

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Click “Information” in Figure 3-4-24, and select “Department Information” from the drop-down list of
“Information Type”, as Figure 3-4-27 shows:

Figure 3-4-27
a)Add Department Information: Input the department name in the input box behind Name. Input the
commonly used mnemonic in the input box behind ID, click .
b)Delete Department Information: Select the items needing to be deleted from the department information
list, click .
(2)Doctor Information Setting:
Select the “Doctor Information” from the drop-down list of “Information Type”, as Figure 3-4-28 shows:

Figure 3-4-28
a)Add Doctor Information: Input the doctor name in the input box behind name. Input the commonly used
mnemonic in the input box behind ID, click .
b)Delete Doctor Information: Select the items need to be deleted in the doctor information list, click
.

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(3)Reference Setting:
Select “Reference” from the pull-down menu of “Information Type”, as Figure 3-4-29 shows:

Figure 3-4-29
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 Setting:
Select “Sex” from the pull-down menu of “Information Type”, as Figure 3-4-30shows:

Figure 3-4-30
Select “Male” or “Female” from the sex list. Only the commonly used sex ID can be changed here.
(5)Age Unit Selection:
Select “Age” from the pull-down menu of “Information Type”, as Figure 3-4-31 shows:

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Figure 3-4-31
Select “Years Old”, “Month”, “Day” or “Hour” from the list of age unit. Only the commonly used age unit ID
can be changed here.
(6)Cost Category Setting
Select “Cost Category” from the pull-down menu of “Information Type”, as Figure 3-4-32 shows:

Figure 3-4-32
a)Add Cost Category: enter a cost category type in the “Name” input box. Enter a commonly used
mnemonic in the “ID” input box. Click to finish the addition.
b)Delete Cost Category: Select a cost category to be deleted. Click to delete the cost
category.
3.4.2.6 Backup Setting
Select “Backup Setting” from Figure 3-4-31, as Figure 3-4-33shows:

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Figure 3-4-33
(1)Backup:
Periodical database backup can prevent data loss.
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.

The backup function can only back up the contents involved in “Setting”.
(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.
3.4.2.7 Abnormal Mark Setting
Click “Abnormal Mark Setting” in Figure 3-4-33, and select “WBC” from the expansion menu, as Figure
3-4-34 shows:

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Figure 3-4-34
Select “RBC/PLT”, as Figure 3-4-35 shows:

Figure 3-4-35
The prompt range of WBC, RBC/PLT abnormal alarm information can be set in this interface. Click
for saving after input, click “Default” to recover, click to exit the interface.
3.4.2.8 Automatic Clean Setting
Click “Auto Clean Setting” in Figure 3-4-34, as Figure 3-4-36 shows:

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Figure 3-4-36
(1)Input automatic clean interval times in “Count Times” box (within 10—200). The set number in the figure
is 200, which means automatic clean will be conducted after each 200 sample tests. The count will return to 0
after clean.
(2)Input rinse DIFF pool interval times in the input box of rinse DIFF pool “Count Times” (between10-600).
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)Input rinse probe interval times in the input box of rinse probe “Count Times” (between10-100). The set
number is 50 in Figure 3-3-34, which means when the function of auto balance pressure is used for 50 times
successively, the instrument will rinse probe automatically. Only “Enable” is ticked, the function of “rinse
probe” is activated.

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Chapter 4 Calibration

4.1 Introduction
Calibration of the instrument is to ensure the accuracy of the results. Calibration must be carried out before
test.

4.2 Calibration Requirements

4.2.1 Calibration Frequency
Calibration is required in the following three cases:
(1)Before first use.
(2)After main part replacement.
(3)Obvious deviation exits in QC running.
4.2.2 Preparation before Calibration
(1)Conduct the following checks before calibration. If any problem is found, do not carry out calibration.
Contact the after-sales department of the manufacturer.
(2)Check the instrument and the reagent to make sure the reagent is enough for the whole calibration process.
If the reagent is used up during calibration, calibration should be conducted again.
(3)Use Calibrator and reagents required by the manufacturer, and refer to the instructions on Calibrator and
reagents.

4.3 Calibration Method

The instrument offers three calibration methods: manual calibration, calibrator calibration and fresh blood
calibration.
In automatic calibration and fresh blood calibration, the relative calibration will be conducted automatically by
the instrument, and the calibration coefficient will be stored in “manual calibration” interface
4.3.1 Calibration with Calibrator

Click “Calibration” of the top menu, and select “Calibrator Calibration” from , as Figure
4-3-1 shows:

Figure 4-3-1

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4.3.1.1 Calibrator Reference Value Input

Click the corresponding line of “Reference”, input values for each parameter (refer to the Calibrator
instructions for the values).
4.3.1.2 Calibration Counting
(1)Click in Figure 4-3-1, the following interface will pop up:

Figure 4-3-2

(2)Click in the above interface. The close sample loader will be available, rotate the loader to make
position 3 aligned with the testing position (Click indicates right positioning), and place the prepared calibrator
in position 3, as Figure 4-3-3 shows:

Figure 4-3-3
(3)Press the “Count” key of the instrument. The following box will pop up when pushing back the loader.

Figure 4-3-4
(4)Start Sample Aspiration→Aspiration Complete→Testing DIFF→Testing RBC/WBC→Data Analysis
→Ready will be displayed in sequence.

● The STAT loader will be opened automatically for the next test.
● After clicking , the position turns into . In the status, close
the loader and click “Count” button on the front panel to conduct tests.
(5)If the sample is not placed in position 3 of the loader, the following box will pop up when pushing the
loader back:

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Figure 4-3-5
The loader will be opened when the above box is prompted. Rotate it to the right position and then push it
back.
If “click” is not heard when rotating the loader, the following box will pop up when pushing back the loader.

Figure 4-3-6
Carry out tests after right positioning.
4.3.1.3 Saving Calibration Results
After obtaining 3 or more counting results, the instrument will carry out CV and calibration coefficient
calculation and save the calibration coefficient results. Saving after 5 times of counting is recommended. With
the increase in calibration times, CV and calibration coefficient will be updated.
The following box will pop up if the results obtained exceed the lower limit set by the software.

Figure 4-3-7

Click 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 results, if the calibration coefficient of a
certain parameter is not within 75%—125%, click , the following box will pop up:

Figure 4-3-8

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The operator should check the reference value input, if the reference value input is correct, the operator should
delete calibration results, re-run the calibration count.
4.3.1.4 Deleting Calibration Results
If any count result has a large deviation from the previous one, click “Test Result” on the left of the screen
after the test, and there will be a “×” mark (namely ), indicating that this result is not counted
during CV, mean, and calibration coefficient calculation. If this result does not need deletion after the test,
click “Test Result” again, and there will be a “×” mark. (namely ), indicating that this test result
is valid and that it can be involved in calculation.
If this result is indeed invalid, click to delete it.
4.3.1.5 Saving Calibration Coefficient
Click in Figure 4-3-1 after 5 times counting, the following box will pop up.

Figure 4-3-9

Click to save the calibration coefficient. It will be saved in “Calibration Coefficient” of “Manual
Calibration” interface, as Figure 4-3-10 shows:

Figure 4-3-10

4.3.2 Fresh Blood Calibration

4.3.2.1 Fresh Blood Preparation
Use EDTA-K2 (1.5 mg/mL ~2.2mg/mL blood) vacuum tube to collect a venous blood sample.
Mix the venous blood and anticoagulant gently at once.
Prepare 3~5 copies of normal fresh blood by using the above method.
4.3.2.2 Calibration Count
Click “Fresh Blood Calibration” in Figure 4-3-1 to enter the fresh blood calibration interface, as shown in the
following figure:

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Figure 4-3-11
(1)Select the number of fresh blood calibration from the pull-down menu behind “Sample No.” Reselect its
“No.” after each fresh blood sample is tested for 5 times.
(2)Put the prepared fresh blood in the instrument to test 3 times, and calculate the mean value. The mean value
will be taken as reference value and input in Figure 4-3-11.
(3)Click in Figure 4-3-11, and the following interface will pop up:

Figure 4-3-12

(4)Click in the above interface. The close sample loader will be available, rotate the loader to make
position 3 aligned with the testing position (“Click” indicates right positioning), and place the prepared fresh
blood in position 3. Press the counting key of the instrument. The following box will pop up when pushing
back the loader.

Figure 4-3-13
The results will be displayed after tests.

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4.3.2.3 Saving Calibration Results

(1)After obtaining 3 or more counting results, the instrument will carry out CV and calibration coefficient
calculation. 5 times counting is recommended. With the increase in calibration times, CV and calibration
coefficient will be updated.
(2)Instrument will carry out different processes according to different calibration results.
The following box will pop up if the result obtained exceeds the lower limit, and a dialogue will pop up as the
following figure shows:

Figure 4-3-14

Click 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.
(3)When saving the counting result after obtaining 3 or more counting results, if the calibration coefficient of a
certain parameter is not within 75%~125%, click , and the following box will pop up:

Figure 4-3-15
The operator should check the reference value input. If the reference value input is correct, the operator should
delete calibration results, and re-run the calibration count.
4.3.2.4 Deleting Calibration Results
If any count result has a large deviation from the previous one, click “Test Result” on the left of the screen
after the test, and there will be a “× “ mark (namely ), indicating that this result is not counted
during CV, mean, and calibration coefficient calculation. If this result does not need deletion after the test,
click “Test Result” again, and there will be a “×” mark. (namely ), indicating that this test
result is valid and that it can be involved in calculation.
If this result is indeed invalid, click to delete it.
4.3.2.5 Saving Calibration Coefficient
Click in Figure 4-3-11 after 5 times counting, the following box will pop up.

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Figure 4-3-16

Click to save the calibration coefficient. It will be saved in “Calibration Coefficient” of “Manual
Calibration” interface.
4.3.3 Manual Calibration
The calibration coefficient displayed on the screen is the calibration coefficient saved after calibration with
calibrator or fresh blood calibration.
Click “Manual Calibration” in Figure 4-3-11 to enter the manual calibration interface, as the following figure
shows:

Figure 4-3-17
Click the corresponding line under “Calibration Coefficient” when the calibration coefficient needs adjustment,
and input the calibration coefficient. Click . “Save succeed” will pop up. Click .

4.4 Calibration History

The software registers information of each calibration.
Click “Calibration History” in Figure 4-3-17 to enter the calibration history interface, as the following figure
shows:

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Figure 4-4-1
The dates, operators, modes, calibration methods and detailed test values of the latest 100 times calibration
will be displayed. If calibration counting is more than 100 times, the previous calibration results will be
covered.
Query:The operator can query the calibration history according to the calibration date, username and
calibration method.

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Chapter 5 Quality Control

5.1 Introduction
After long-term use, error may occur, which may lead to unreliable results. Quality control (QC) provides an
effective way to detect error. The accuracy and precision of daily sample results can be checked through QC
tests.
In order to ensure the reliability of the sample results. Low, medium and high level Control should be used
respectively to conduct QC for the instrument once every day.
QC tests cannot be done until the instrument is calibrated correctly.

5.2 QC Method
The instrument provides three QC methods: L-J QC, ⎯x QC and X-B floating mean QC.
5.2.1 L-J QC
Under “L-J” QC, the operator can carry out quality control for 25 parameters. The instrument provides 12 QC
documents in order to save quality control parameters and results. Each quality control document can save up
to 400 groups of quality control results. When the running number of quality control is more than 400, the new
QC results will cover the old ones.

Click “QC” in the main interface and select “L-J/Xbar” from , as shown in Figure 5-2-1.

Figure 5-2-1
5.2.1.1 Quality Control Setting
(1)Lot No. Information Setting
Click “Setting” button to enter the QC information setting interface, as shown in Figure 5-2-2:

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Figure 5-2-2
a)Select File No.
Click the pull-down menu of “File No.” to select the file needs QC, the range is 1—12.
b)QC Lot No. Input
Input the corresponding QC lot No. in the “Lot No.” box according to the Control instructions.
c)Validity Setting:
Click the pull-down menu of “Validity” to set the validity according to the instructions.
d)QC Level Selection:
Select QC level (High, Mid, Low) from the pull-down menu of “Level”. Each lot No. corresponds to one
level.
e)Target/Deviation Limit
Input the corresponding target value and deviation limit according to the QC instructions.
Click when the above input is completed. “Saving Succeed” will pop up, and click
.

The input lot number and validity should be those marked on the instructions.
(2)Preset Value
The operator can select any QC results from the QC chart (at least 3), calculate the mean, SD, and CV% of the
QC results. Set them as preset values when editing QC.
(3)Deviation Limit Setting
If the display form of deviation limit, or the calculation method of deviation limit in pre-set value needs to be
adjusted, following these steps:
a)Click “Setting” in the main menu, and select “QC Setting” from the left, as Figure 5-2-3 shows:

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Figure 5-2-3
b)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 an 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 a percent. “Range” will use 2 times the variation coefficient (2CV) or 3 times the variation coefficient
(3CV) as the deviation limit.
c)Click in Figure 5-2-3. The preset value is obtained according to the set method, and it is taken
as the target value and deviation limit of the current QC file. The corresponding position of each parameter
will be displayed in Figure 5-2-2.
(4)Removal of Abnormal QC Points
If any abnormal QC point occurs, the preset value can be obtained after deleting the abnormal point. The
operating steps are as follows:
a)In Figure 5-2-2, click at the right lower corner, and the following figure pops up:

Figure 5-2-4

b)Click in the above figure, and the screen will switch to the QC interface, as the following
figure shows:

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Figure 5-2-5
If the first point on the right is an abnormal point, click it, the red cursor line is on the first point on the right.
Click , and the selected QC point will become blue. To continue to remove other QC points,
click them, and the red cursor line will be on them. Click . When obtaining pre-set values for
calculation, removed QC points are not included (blue QC points).
Click “Calculation” after the points are deleted, the screen will return to "Setting" interface, and the result will
be displayed.
If the valid QC point number is less than 3, click “ ” button in Figure 5-2-2, or click
“ ” button in Figure 5-2-5. Figure 5-2-6 will pop up:

Figure 5-2-6
If the above operation is found to be wrong, click the removed point to move the red cursor line onto it, and
click “Add”. The blue QC point will turn red or green. The removed point will return to normality.

Valid QC points are taken as the reference and deviation limit when taking a preset value.
5.2.1.2 QC Counting

Click “ ” in Figure 5-2-5 to enter the QC count interface, as shown in Figure 5-2-7.

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Figure 5-2-7

● The specified Control of the manufacturer should be used to avoid QC result error.
● Refer to the instructions for the use of Control.
● The result will not be reliable when instrument failure occurs.

Click in Figure 5-2-7, and the following interface will pop up:

Figure 5-2-8

Click in the above interface. The close sample loader will be available, rotate the loader to make
position 1 aligned with the testing position (“Click” indicates right positioning), and place the prepared
Control in position 1, as Figure 5-2-9 shows:

Figure 5-2-9

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Press the count key of the instrument. The following box will pop up when pushing back the loader.

Figure 5-2-10
Start Sample Aspiration→Aspiration Complete→Testing DIFF→Testing RBC/WBC→Data Analysis→Ready
will be displayed in sequence.

● The STAT loader will be opened automatically for the next test.
● After clicking , the position turns into . In the status, close
the loader and click “Count” button on the front panel to conduct tests.
If the sample is not placed in position 1 of the loader, the following box will pop up when pushing the loader
back:

Figure 5-2-11
The loader will be opened when the above box is prompted. Rotate it to position 1 and then push it back.
If “Click” is not heard when rotating the loader, the following box will pop up when pushing back the loader.

Figure 5-2-12
Carry out tests after right positioning.
If the count result is lower than the lower limit set by the software, or higher than the display range, the
following box will pop up:

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Figure 5-2-13

Click in the above Figure. The count result will be deleted.

(1)QC Data Query
The stored QC results can be queried through button and , after QC tests. If
QC results are outside the QC range, the results will be displayed in the red background.
(2)QC Data Modification
After QC tests, if a result needs modification, double-click it. Then modify it and click button to
save the modified result.
(3)QC Data Printing
To print a single QC result, click button to print the current record.
(4)QC Data Deletion
To delete the current QC result, click button to delete the current record.
5.2.1.3 QC Result Review
Click “QC Graph” in Figure 5-2-7 to enter the review interface, as shown in Figure 5-2-14:

Figure 5-2-14
(1)QC Graph Setting
Click in “QC Graph” interface to set the parameters or move the display position, as Figure
5-2-15 shows:

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Figure 5-2-15
a)QC Item Setting
Select parameter names from Figure 5-2-15, and click . Only the selected parameter will be
saved.
b)QC Item Moving:
If the parameters need to be ordered again, select a parameter needing to be adjusted (the selected line is
blue), click “ ” or ” ” to move the selected parameter.
(2)Explanation of QC Graph interface
a)If the QC counting number is less than 3, the right side of the QC graph will not display the QC result of
each parameter.
b)The abscissa of the QC graph indicates the QC count number. The ordinate indicates the QC count result
of each parameter.
c)Vertical lines make the count data of the same group. For each parameter, the QC graph can display up to
400 points.
d)For each parameter, the three data on the left of the QC graph correspond to the three boundary values of
the QC graph, as shown in Figure 5-2-5.
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
e)For each parameter, the three data on the right of the QC graph 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.

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Check the target value and deviation limit.

Check whether the background test is normal.
Conduct QC count again if the above two points are normal. If abnormity remains, conduct QC count after
instrument calibration.
Contact the manufacturer’s after-sales service department if abnormal points still exit after calibration.
(5)QC graph printing
Click in Figure 5-2-7. If “Preview before printing” is selected in printing setting(namely
), preview can be conducted before printing, as the following figure shows:

Figure 5-2-16

Connect the printer, and click to print the report.

(6)QC graph query: select “start date” and “end date” and then click “Query” to check the corresponding QC
graph.5.2.1.4 QC List
Different QC documents can be queried.
Click “QC List” in Figure 5-2-14, and select a QC file number from the pull-down menu of “File No.” to enter
the interface as Figure 5-2-17 shows:

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Figure 5-2-17
(1)Delete All
The operator can delete all the QC count results of the current QC file.
Click in Figure 5-2-17, as and the following figure pops up:

Figure 5-2-18

Click “ ”, and the interface will display “Delete Succeed”, which indicates that all the QC results
are deleted.
(2)Delete
The operator can delete a certain QC result of the current QC file.
Select a QC data needs to be deleted from Figure 5-2-17, and click . A box like Figure 5-2-18will
pop up. Click “ ”, and the interface displays “Deleting Succeed”, which indicates the selected QC
result is deleted.
(3)Print
The operator can print the QC count result of the current QC file.
(4)Export
The operator can export all the QC count results of the current QC file.
(5)Communicate
The operator can transmit the QC count results of the current QC file to LIS.
(6)Import
The operator can import all the QC count results.

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5.2.2 ⎯x QC
⎯x QC: the mean value of two testing results is saved as one QC point in the QC chart.
The operation is same as “5.2.1 L-J QC “.
5.2.3 X-B QC
X-B floating mean method is proposed by Dr. BrianBull. Through monitoring the stability of red blood cell
parameter, such as MCV, MCH, MCHC, etc. to monitor instrument performance. It belongs to the quality
control without control. Together with the quality control with control, they all belong to instrument
performance monitoring method which can reflect instrument performance from different aspects. They are not
mutually replaceable. The X-B quality control is recommended when the daily sample is greater than 100 per
day. This quality control method requires the use of random sample, therefore, the classified sample is not
suitable. It offers the upper and lower limit to form a reference range. Observe the changing trend of result
within the reference range.
This instrument conduct X-B QC toward MCV, MCH, MCHC. The sample number in each group can be set as
20~200. The sample is come from normal counting result of the instrument, without classifying whole blood
and pre-dilution mode.
Calculation is needed before testing, because X-B reference value is obtained through analyzing a large
number of random sample.
5.2.3.1 QC Setting
The QC parameter 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
5-2-19 shows:

Figure 5-2-19
Sample No. selected for each X-B point can be 20~200, the recommended number is 20.
Click ON under “X-B QC”, click , “Saving succeed” will pop up, click .

(2)Click “QC” in the above menu, and select “X-B” from , as Figure 5-2-20 shows:

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Figure 5-2-20
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 after setting, “Saving Succeed” will pop up, click .

5.2.3.2 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.
5.2.3.3 QC Graph Review
Click “QC Graph” in Figure 5-2-20 to enter the X-B QC graph review interface, as shown in Figure 5-2-21.

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Figure 5-2-21
(1)QC graph explanation
The abscissa is the counting result number. The ordinate is the result.
For each parameter, the three numbers on the left of the QC graph correspond to the three boundaries of QC
graph. From top to bottom, they represent the upper limit, target value and lower limit.
Upper limit: Control reference value + deviation limit
Target: Control reference value
Lower limit: Control reference value - deviation limit
For each parameter, the three number on the right of the QC 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)QC Data Modification
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 Query
The QC result can be queried 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.
5.2.3.4 QC List Review
Click QC list in Figure 5-2-21to enter the X-B QC list review interface, as shown in Figure 5-2-22:

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Figure 5-2-22
(1)Delete
Click the QC data behind corresponding No., the line will turn blue, click , as Figure 5-2-23
shows:

Figure 5-2-23

Click “ ” 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 , and the following figure pops up:

Figure 5-2-24

Click “ ” in the above Figure, “Delete Succeed” will be displayed, all the records will be deleted.

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(3)Export
Click to enter the following figure:

Figure 5-2-25
Input the document name in the input box behind “Document Name”, and select the saving path, click
. (Note: The exported document will be saved in EXCEL form.)
(4)LIS Transmission
Click , the data will be transmitted to LIS, as the following figure shows:

Figure 5-2-26
(5)Import: Click “Import”, the operator can import the QC counting result in the interface.

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Chapter 6 Normal Operation

6.1 Introduction
This chapter describes the whole process of daily operation from start to shut down and focus 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

6.2 Preparation before Operation

Check the instrument before using according to the following requirement.
(1)Check the waste barrel: ensure that the waste barrel is empty before daily use.
(2)Check pipeline: Check if the pipelines which are connected with reagent, waste barrel bend or connect
closely.
(3)Check the power supply: Check the connection of power plug between the instrument and the computer.
(4)Check the printer: Check the connection of data line and the power plug between the computer and the
printer. Check the printing paper and its installation.
(5)Check the barcode reader: Check the connection of cable between the computer and the barcode reader.

6.3 Daily QC

QC analysis should be conducted every day before sample analysis to ensure reliable result. For the
detailed operation, please refer to chapter 5.

6.4 Sample Preparation

6.4.1 Whole Blood Sample Preparation
(1)Use clean EDTA-K2 (1.5 mg/mL ~2.2 mg/mL blood) anticoagulant vacuum tube to collect venous blood
sample for more than 1mL.
(2)Mix the venous blood with anticoagulant promptly.

● Use clean EDTA-K2 anticoagulant vacuum tube, silicified glass/plastic tube and 20μL silica glass
capillary.

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● The sample that needs WBC differential or platelet count should be stored at room temperature. It
should be used within 8 hour after collection.
● If the analysis results of PLT, MCV, or WBC 5 part differential count are 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.
● The sample should be mixed again before use after a period of storing.
6.4.2 Add Diluent

Figure 6-4-1

(1)Click in shortcut area (6-4-1), as the Figure 6-4-2, Figure 6-4-3 show:

Figure 6-4-2

Figure 6-4-3
(2)Take a clean centrifuge tube, place it at position 4 of STAT loader, rotate the STAT loader to align position
4 with test position, close the door of STAT loader, as Figure 6-4-4 shows:

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Figure 6-4-4
Press aspiration key, the diluent will be dispensed into the tube of Position 4, as Figure 6-4-5 shows:

Figure 6-4-5
Move the centrifuge tube after the door of STAT loader bounced.
(3)After dispensing the diluents, dispense 20 μL peripheral blood into the centrifuge tube that contains diluents
immediately. Then mix them.
(4)Click in Figure 6-4-3, as Figure 6-4-6 shows:

Figure 6-4-6
Cancel diluent adding to complete a preparation of pre-dilution sample.
(5)If there are some samples need to be diluted, the first preparation of pre-dilution sample is completed, as
Figure 6-4-2 shows, place the clean centrifuge tube at position 4 of STAT loader, close the door of
STAT loader and press the aspirate sample key, the second preparation of pre-dilution sample is completed.
The rest can be done in the same manner and pre-diluted samples can be prepared up to 20 continuously.

● The operator can also use pipette to aspirate 180μL diluent and dispense 20μL peripheral blood into
the centrifuge tube immediately. Then mix them.
● When “pre-dilute” is selected, “Attention! 1:10 Dilute sample” will be prompted in sample
information.
● The diluent should be protected from dust, or the analysis error will occur.
● After 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, or the analysis result will not be reliable.

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● The sample should be re-mixed after placing for a period of time before use.
● The stability of the analysis result on pre-dilution mode should be evaluated according to their own
sample number, sample collection method and technical level.

6.5 Sample Testing of Close-Whole Blood Mode

6.5.1 Sample Information Edition

Samples can be edited before analysis.

Patient information can be edited or modified if the lock key is in the status of , as Figure 6-5-1 shows:

Figure 6-5-1
(1)Sample Information Edition: refer to 3.2.1.1
(2)Patient Information Edition: refer to 3.2.1.2
6.5.2 Sample Analysis Procedures
In main interface, if the current mode is “Close-Whole Blood”, testing can be carried out directly. Or set the
current mode as “Close-Whole Blood”.

● Set the reference range in setting interface, otherwise, incorrect alarm may be prompted.
● Conduct sample test after working mode selection, the default reference range is “General”. The
alarms after test is in accordance with the reference range of General.
6.5.2.1 Test Interface

In main interface, press . As shown in Figure 6-5-2:

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Figure 6-5-2
6.5.2.2 Analysis Mode and Sample No. Setting
(1)In the dialogue of “Analysis Mode”, select Microscale-Whole Blood (No.2 position) or Close-Whole Blood
(No.3 position).
(2)In the dialogue of “Test Mode”, select 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 25
parameters, scattergram, histogram and 10 research parameters.
(3)In the dialogue of “Closed Counting Mode”, select Press counting key to test or Close STAT loader to test.
(4)In the dialogue of “Sample No.” edit sample No.
(5)In the drop-down list of Reference, select the reference range for next sample analysis, and default as
“General”.

● The upper limit of sample No. is 15, “—” is allowed while “.” is not allowed, or the software will
prompt invalid input.
● The input sample No. cannot be the same with the daily tested sample No. or edited sample No., or the
new record will replace the tested or edited one.

(6)Click in Figure 6-4-2 for saving after the above settings.

6.5.2.3 Sample Analysis
(1)Sample Position Selection: For 2mL vacutainer, select “Close-Whole Blood (No.3 Position)”. For 0.5mL
vacutainer, select “Microscale-Whole Blood (No.2 Position)”. Click in Figure 6-5-2. The running
mode turns to be Close-Whole Blood mode. The door of STAT loader will open automatically, rotate the
STAT loader to align position 3, 2 with testing position (“Click” indicates right positioning), as Figure 6-5-3
shows:

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Figure 6-5-3
(2)On ready status of counting (the green indicator is lighted), shake the tube up and down lightly to mix it
well and place it in position 2 or 3 of STAT loader, close the door of STAT loader. Press “Count” to test (If
“Close STAT Loader to Test” is selected, test will start directly after closing the door of STAT loader). Result
will be saved and displayed after testing. The STAT loader will be available after aspirating the sample.
(3)Place the next sample in position 2 or 3 of STAT loader, close the door of STAT loader. Press “Count” to
test (If “Close STAT Loader to Test” is selected, test will start directly after closing the door of STAT loader).

(4)Click in main interface to print the report. Or click to enter into data list, then
press or to print the report.
(5)If the sample is placed in STAT loader, the position (Figure 6-5-3) is not in accordance with the set position
(select in Figure 6-5-2), the following dialogue will pop up when and then close the door of STAT loader.

Figure 6-5-4
The door of STAT loader will open again when the above dialogue prompts. Rotate it to the right position and
then close the door and test.
If “Click” is not heard when rotating the STAT loader, the following dialogue will pop up when close the door
of STAT loader.

Figure 6-5-5
Test after right positioned.

● The disposable vacuum blood collection tube can be used for 5 times at most. Because fragments
produced by repeatable puncture may lead invalid test result.

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● In the process of testing, the interface of Picture and of Research Parameter/microscopic examination
result can be checked. But no operation can be conducted. The data will be saved into the data review
after test automatically.
● In analyzing, if aperture is clogged, and there is “?” behind the test result, meanwhile, “aperture is
clogged, please remove clog or rinse aperture” will prompt, this result is unreliable. Please test after clog
removal.
● The result will be inaccurate if the temperature exceeds the normal working temperature range of the
instrument.
6.5.3 Picture Check

In shortcut area of Figure 6-5-1, click , click “Picture” to check the pictures of the test results, as
Figure 6-5-6 shows:

Figure 6-5-6
Histogram of RBC, PLT and WBC and histogram and scattergram of WBC 4 diff will be displayed.
6.5.4 Research Parameter Check
Click “Research Parameter/microscopic examination result” in Figure 6-5-6to check 10 research parameters,
as Figure 6-5-7 shows:

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Figure 6-5-7

6.5.5 Research Parameter Print

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.

“Please input microscopic result” will prompt if print the research parameter directly without inputting
microscopic result.

6.6 Close-Prediluted Sample Testing

6.6.1 Working Mode Checking
(1)Check the working mode is “Predilution Mode”, otherwise, switch the current mode to “Predilution” mode.

The pipeline will be rinsed after mode switching.

(2)Click in main interface, the following dialogue will pop up:

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Figure 6-6-1
(3)Change analysis mode and sample No.: the detailed operation procedures are the same as 6.5.2.2
6.6.2 Sample Analysis
(1)After selection, click in Figure 6-5-1, the mode will switch to “Close-Prediluted” mode. And the
door of STAT loader will open automatically, then rotate the STAT loader to align position 4 with testing
position (“Click” indicates right positioning), as Figure 6-6-2 shows:

Figure 6-6-2
(2)On ready status of counting (the green indicator is lighted), shake the tube up and down lightly to mix it
well and place it in position 4 of STAT loader, close the door of STAT loader. Press “Count” to test (If “Close
STAT Loader to Test” is selected, test will start directly after closing the door of STAT loader). Result will be
saved and displayed after testing. The STAT loader will be available after aspirating the sample.
(3)Place the next sample in position 4 of STAT loader, close the door of STAT loader. Press “Count” to test (If
“Close STAT Loader to Test” is selected, test will start directly after closing the door of STAT loader).

(4)Click in main interface to print the report. Or click to enter into data list, then press
or to print the report.

● In the process of testing, the interface of Picture and of Research Parameter/microscopic examination
result can be checked. 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.

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6.7 Auto-Whole Blood Mode

6.7.1 Barcode and Paste Requirement
6.7.1.1 Barcode Type
CODE128, CODE39.
6.7.1.2 Barcode Label Size
(1)CODE128:4≤valid number≤15.
(2)CODE39:4≤valid number≤9.

Width

Starting Valid length Ending

Blank Blank

Figure 6-7-1
6.7.1.3 Barcode Cutting
The starting blank and ending blank should be no less than 3mm (Figure 6-7-1).
6.7.1.4 Barcode Label Paste Requirement
(1)Paste the barcode smoothly.
(2)Paste the barcode in the right position, the lower edge of barcode (including starting blank) should run
along the lower edge of tube cover. And guarantee the barcode can be seen through the longitudinal notch of
tube rack after the tubes are placed in the tube rack.
6.7.2 Sample Information Edition

Sample can be edited before sample analysis.

Patient information can be edited or modified if the lock key is in the status of , as Figure 6-7-2 shows:

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Figure 6-7-2
6.7.2.1 Sample Information Edition:
refer to 3.3.1.1.
6.7.2.2 Patient Information Edition:
refer to 3.3.1.2.
6.7.3 Analysis Mode and Sample No. Setting
In main interface, press the . As shown in Figure 6-7-3:

Figure 6-7-3
(1)In the dialogue of “Analysis Mode”, select Microscale-Whole Blood (No.2 position) or Close-Whole blood
(No.3 position ).
(2)In the dialogue of “Test Mode”, select 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 25

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parameters, scattergram, histogram and 10 research parameters.

(3)In the dialogue of “Closed Counting Mode”, select Press counting key to test or Close STAT loader to test.
(4)In the dialogue of “Sample No.” edit sample No.

● The upper limit of sample No. is 15, “—” is allowed while “.” is not allowed, or the software will
prompt invalid input.
● The input sample No. cannot be the same with the daily tested sample No. or edited sample No., or the
new record will replace the tested or edited one.
(5)In the drop-down list of Reference, select the reference range for next sample analysis, and default as
“General”.
(6)Rack No.: If “Automatic Rack No. Identification” is selected, test will be conducted from No.1. Tube No. is
the sequence tube No. on the rack. If “Automatic Rack No. Identification” is not selected, test will be
conducted from the input rack No.
(7)Do get barcode from scanner?: In auto-whole blood testing, internal barcode reader can be selected, if use it,
sample barcode in data browse /list is the barcode of test tube; if do not use it, sample barcode in data browse
/list is the edited barcode in sample register.
(8)Click OK in Figure 6-7-3 to save the above settings.
6.7.4 Sample Analysis Procedures

● Set the reference range in setting interface, otherwise, incorrect alarm may be prompted.
● Conduct sample test after working mode selection, the default reference range is “General”. The
alarms after test is in accordance with the reference range of General.
● The disposable vacutainer can be used for 5 times at most. Because fragments produced by repeatable
puncture may lead invalid test result.
6.7.4.1 Analysis Interface

Click in the main interface, the following interface pops up:

Figure 6-7-4
6.7.4.2 Sample Analysis
On ready status of counting (the green indicator is lighted), place the prepared sample tube on the tube rack,

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and place the tube rack on the right side of the sample conveyor (there is a groove on the bottom of the tube
rack, and the groove should be toward right side of the sample conveyor), click in Figure 6-7-3 or press
“Count” on the front cover of the instrument to test. In the process of testing, the running status displays: Start
Sample Aspiration→Aspiration Complete→Testing DIFF→Testing RBC/WBC→Data Analysis, meanwhile,
the green indicator on the front cover of the instrument is twinkling.

According to the registered sample information, label the corresponding sample No. on the sample tube,
then place these sample tubes on tube rack based on the sequence of sample No.
(1)The result of each sample will be saved to query interface. The racks will be loaded to the left side of the
autosampler after testing. The operator can take away the racks.

(2)Click to print the report; or click in main interface to enter into data list interface,
and then click or to print the report. Refer to Chapter 7.
6.7.5 Picture Check
Click “Picture” in Figure 6-7-4 to check the pictures of the test results, as Figure 6-7-5 shows:

Figure 6-7-5
Histogram of RBC, PLT and WBC; histogram and scattergram of WBC 4 diff will be displayed.
6.7.6 Research Parameter Check
Click “Research Parameter/Microscopic examination result” in Figure 6-7-5 to check 10 research parameters,
as Figure 6-7-6 shows:

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Figure 6-7-6

6.8 Emergency Sample Analysis

(1)In the process of testing, click in shortcut area if Emergency Sample Analysis is needed. The
automatic sampling will stop after the pierced sample is tested, and the mode will be switched to “Close” mode,
and Figure 6-8-1 will pop up:

Figure 6-8-1
The default emergency sample No. starts from 0-1:
(2)Sample Position Selection: For 2mL vacutainer, select “Close-Whole Blood (No.3 Position)”. For 0.5mL
vacutainer, select “Microscale -Whole Blood (No.2 Position)”. For prediluted sample, select “Close-Prediluted
(No.4 Position)”. Click in Figure 6-8-1. And the door of STAT loader will open automatically,
rotate the STAT loader to align position 3, 2 or 4 with testing position (“Click” indicates right positioning), as
Figure 6-8-2 shows:

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Figure 6-8-2

● Emergency sample can only be tested on “Close-Whole Blood” or “Close-Prediluted” mode.

● The icon change into indicates successful emergency sample insertion.

● Emergency sample can only be tested by pressing the “Count” key.
(3)On ready status of emergency counting (the yellow indicator is lighted), place the emergency sample in
position 2,4 or 3 of STAT loader, close the door of STAT loader. Press “Count” to test. In the process of
testing, the running status displays: Start Sample Aspiration→Aspiration Complete→Testing DIFF→Testing
RBC/WBC→Data Analysis, meanwhile, the green indicator on the front cover of the instrument is twinkling.
Result will be saved automatically after test.

(4)The door of STAT loader will open automatically after test. Click to stop emergency test. Switch the
mode to “Auto-Whole Blood” for routine sample test.

(5)Click in main interface to enter into data list interface. Edit patient information compared with
Sample No., Rack No. and Tube No. (both Rack No. and Tube No. of emergency sample are 0), and in
accordance with 3.3.1.1 and 3.3.1.2. Click or to print the report. Refer to
Chapter 7.
(6)If the sample is placed in STAT loader, the position (Figure 6-8-2) is not in accordance with the set position
(select in Figure 6-8-1), the following dialogue will pop up when and then close the door of STAT loader.

Figure 6-8-3
The door of STAT loader will open again when the above dialogue prompts. Rotate it to the right position and
then close the door and test.
If “Click” is not heard when rotating the STAT loader, the following dialogue will pop up when close the door
of STAT loader.

Figure 6-8-4

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Test after right positioned.

● In the process of testing, other interfaces can be checked. 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.

6.9 Parameter Alarm

6.9.1 Parameter Alarm Types
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 marked with “?”, “!”, that means the result is unreliable.
6.9.2 Differential or Abnormal Form Alarm
The instrument can prompt alarm of abnormity and unreliability of WBC, RBC/HGB and PLT according to
the histogram and scattergram. As shown in Table 6-9-1:
Table 6-9-1
(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 NEU#>11.0*10^9/L

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

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

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

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

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

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

(2)WBC unreliable alarm information

Information Meaning Judging Standard

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

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(3)RBC/HGB abnormal alarm information

Information Meaning Judging Standard

Abnormal RBC distribution Abnormal RBC histogram distribution Abnormal RBC histogram

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

Small RBC Smaller MCV MCV<70fL

Big RBC Bigger MCV MCV>110fL

RBC increase RBC increase RBC>6.5*1012/L

Anemia Anemia HGB<100g/L

Low pigment Low pigment MCHC<290g/L

Bimodality RBC bimodality distribution RBC histogram has two or more peaks.

(4)RBC/HGB unreliable alarm information

Information Meaning Judging Standard

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

(5)PLT unreliable alarm information

Information Meaning Judging Standard
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

Information Meaning Judging Standard
Calculate and compare the special analytic
PLT aggregation？ PLT aggregation maybe exists.
parameters.

6.10 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.

6.11 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 puncture 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).

6.12 Shutdown

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In order to ensure the stability and accuracy test result tested by the instrument. Shutdown is required
after 24 hours continuous working. The operator must follow these steps to shut down the instrument.
Shutdown includes instrument shutdown and software exit.
6.12.1 Instrument Shutdown

(1)Click “ ” in the shortcut area, or select Test→shutdown. As shown in Figure 6-12-1:

Figure 6-12-1

(2)Click , “Shutdown Instrument” will pop up, the instrument will conduct pipe and counting pool
rinsing and soaking in the process of shutdown, the following dialogue will pop up after the previous steps:

Figure 6-12-2
(3)Switch to “O” on the right of the instrument to finish shutdown.
(4)Empty the waste barrel and deal with the waste solution after shutdown.

Click “Restart” in Figure 6-12-2 if more tests are needed.

6.12.2 Software Exit

(1)Click ,or select “Menu”→“Exit System”, the following dialogue will pop up:

Figure 6-12-3

Click to exit the software to finish the whole shutdown process.

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Chapter 7 Record Query

7.1 Introduction
The instrument will store the result into database automatically after each test. The maximum storage capacity
is 100,000. The operator can query the sample result stored in the database. The result will be covered if the
storage number reaches the maximum.

Click in main interface to enter into query interface, as Figure 7-1-1 shows:

Figure 7-1-1
The results displayed in the database are in testing sequence (the last result is at the first place). The default
mode is the list mode.
If the screen cannot display all results, press “Page Down” or “Page Up” to switch the pages. The position of
the current result and the total number of database will be displayed in the form of “Pos/Total” at the bottom of
the interface.

7.2 Record Selection

(1)If the sample with known position needs to be queried, click in Figure 7-1-1, and select

“Condition” in its drop down list , as Figure 7-2-1 shows:

Figure 7-2-1

(2)Input the “Start No.” and “End No.” need to be queried in Figure 7-2-1, click ”. The sample

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result will be displayed on the current screen and will be selected with (there is a in front of sample
position No.).

The input sample position should be within the range of sample database, otherwise, “Input range error,
please input again” will be prompted.

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

7.3 Print
The sample results can be printed in sample query interface.
7.3.1 Single Sample Printing
Click in Figure 7-1-1, if “Preview before print or not” ( ) is
selected in “Print Setting”, as the following figure shows:

Figure 7-3-1

Connect with printer correctly, and 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”.
7.3.2 Bulk Print
Click in Figure 7-1-1, as Figure 7-3-2 shows:

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Figure 7-3-2

Select the test date of the report, and input the start and end sample No., if “Audited” ( ) is
selected and “Preview before print or not” ( ) is selected, the report can be
previewed, as the following figure shows:

Figure 7-3-3

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”.

7.4 Query
The data can be queried through different conditions. Click in Figure 7-1-1, and select

“Condition” in its drop-down list , as shown in Figure 7-4-1.

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Figure 7-4-1
Users can select different query conditions to query, including: sample No., barcode No., test time, test mode,
analysis mode, case No., bed No., name, gender, department, deliver doctor, auditor and tester. The results can
be queried according to one condition or multi-condition.
7.4.1 Query According to Sample No.
Input the sample No. in the box behind “Sample No.” need to be queried in Figure 7-4-1, if the input sample
No. is “14”, click , the sample results with No. “14” will be displayed, as Figure 7-4-2shows:

Figure 7-4-2

7.4.2 Query According to ID Number

Input the barcode No. in the box behind “Barcode” need to be queried in Figure 7-4-1, click , the
results will be displayed.
7.4.3 Query According to Test Mode and Date
In Figure 7-4-1, 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 , the records

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will be displayed.
7.4.4 Query According to Case No.
Input the Case No. in the box behind “Case No.” need to be queried in Figure 7-4-1, click , the
results will be displayed.
7.4.5 Query According to Bed No.
Input the Bed No. in the box behind “Bed No.” need to be queried in Figure 7-4-1, click , the results
will be displayed.
7.4.6 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 7-4-1,
click , the results will be displayed.
7.4.7 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 7-4-1, click
, the results will be displayed.
7.4.8 Query According to Auditor
Select the auditor of the sample in the drop-down list behind “Auditor” need to be queried in Figure 7-4-1,
click , the results will be displayed.
7.4.9 Query According to Tester
Select the tester of the sample in the drop-down list behind “Tester” need to be queried in Figure 7-4-1, click
, the results will be displayed.

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.

7.5 CV Calculation and Trend Chart

7.5.1 CV Calculation
Users can select 3 or more records arbitrarily in test results to calculate the CV, Mean and SD. Click the No. in
front of record(√) in Figure 7-1-1 (selected records should be 3 or more), and click , as Figure
7-5-1and Figure 7-5-2 shows:

Figure 7-5-1

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Figure 7-5-2

Click in above figure to exit the interface.

If the selected records are less than 3, the interface will be:

Figure 7-5-3

● The repeatability of the results is invalid if any parameter of the selected sample is invalid.

● Sample to be tested cannot be selected to calculate CV, or it will prompt .

7.5.2 Trend Chart
Click in Figure 7-5-2, as Figure 7-5-4 shows:

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Figure 7-5-4
User can edit the deviation limits corresponding to the parameters in the trend chart based on the requirements,
and click after editing. Click in Figure 7-5-3, as the following figure shows:

Figure 7-5-5

User can set the item need to be checked based on the requirements, and select in front of the parameter,
or click , , , , modify the position of parameters in the trend
chart, and click to exit after setting.

7.6 Bulk Audit

The user can conduct bulk audit in result query, click in Figure 7-1-1, as Figure 7-6-1 shows:

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Figure 7-6-1
Select the test date in the drop down list of “Test Date”, and input the start sample No. and end sample No.,
click , the auditor information of audited sample result will be displayed behind auditor.

7.7 Communication
7.7.1 Communication Interface

Click list review interface, and select proper records in the list , and data
transmission can be conducted. The interface is shown as follow:

Figure 7-7-1
Transmission Succeed is displayed, as Figure 7-7-2 shows:

Figure 7-7-2

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7.7.2 Sample Application

Select “Sample Application” In the drop down list , The interface is shown as follow:

Figure 7-7-3

Input start and end sample No., click , and apply patient information from LIS system, and store the
applied patient information into the corresponding interface of the record of the software.

7.8 Delete
Click in Figure 7-1-1, and select the records need to be deleted in its drop-down

list , as Figure 7-8-1 shows:

Figure 7-8-1

Click in above figure to delete the records.

7.9 Export
The exported data can be saved.
Click in Figure 7-4-2, select the data needs to be exported in its drop-down

list , as the following figure shows:

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Figure 7-9-1

Input the file name in the input box behind “File Name”, and select the saving path, click , the
following box will pop up:

Figure 7-9-2
Indicate successful data export.

The exported file should be saved in EXCEL form.

7.10 Sample Addition

Select one record and click in Figure 7-4-2, the sequence No. of the added sample is the
selected sequence No. plus one, sample information and patient information can be edited after addition, click
Enter or to save the edited information. The test status of added sample is to be
tested, the print status is , switch to the counting interface, the print status on the printed report is
“unprinted”.

7.11 Patient Information Modification

In Figure 7-4-2, select a record to be modified and modify the patient information, click Enter or
to save the modified information.

7.12 Recheck
Select the record which is suspected and right click in Figure 7-1-1, as Figure 7-12-1 shows:

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Figure 7-12-1
Click recheck in Figure 7-12-1, the status becomes recheck, then, testing (run the regular test). last, completed
(finish the recheck).
In the process of recheck, the status of counting interface is the same with what of result query.

7.13 Chart Query

User can check single record in chart form, in Figure 7-1-1, double click the sample result line, as Figure
7-13-1 shows:

Figure 7-13-1
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, audited and print in this interface.

7.14 Review Compare

Click test in main interface, then click review, as the following figure shows:

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Figure 7-14-1
Click review compare in Figure 7-14-1, the following figure prompts:

Figure 7-14-2

7.14.1 Parameter Setting

User can set the parameter that will be displayed and can move the position of parameters. Click setting in
Figure 7-14-2, the following figure prompts:

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Figure 7-14-3
(1)Item setting:
Select the parameter items need to be displayed in Figure 7-14-3, click when the check box
displays , the selected parameter items will be displayed.
(2)Item moving:
Select the parameter items need to be adjusted (the line is blue) if the parameter items need to be reordered,
click or to carry it out.
7.14.2 Compare List
Input name “Li” and do not input case No. in Figure 7-14-2. Select a test time, and click “Query”, the
following figure prompts:

Figure 7-14-4

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The test result of Case No.456 which is in the selected Test Time will be displayed.
Input Case No. “456” Name Li and Test Time in Figure 7-14-2, click Query, the following figure prompts:

Figure 7-14-5
The test result of Case No.456 and Name Li which is in the selected Test Time will be displayed.
Input Case No. “456” Name Wang Hong and Test Time in Figure 7-14-2, select Exact Search click Query, the
following figure prompts:

Figure 7-14-6
The test result of Case No.456 and Name Wang Hong which is in the selected Test Time will be displayed.
7.14.3 Tendency
Click Tendency after the above Query, the following figure prompts:

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Figure 7-14-7
Select different parameter items in the drop-down list of Parameter, for instance, select WBC to carry out the
tendency of WBC. The corresponding WBC values are displayed in the bottom of Figure 7-14-7.

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.

7.15 Data Backup

Click Backup in Figure 7-14-1, the following figure prompts:

Figure 7-15-1
There are 3 types of test data backup:
(1)Click Selected Record to select the records need to be backed up. Selected Records refer to the items
with .
(2)Click All Records to backup all the items.

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(3)Click Input Range, select the start and end date after Test Date, and backup the items that are in the selected
range.
Click OK, the following figure prompts:

Figure 7-15-2
Select the path of backup, input File Name, and click save, the following figure prompts:

Figure 7-15-3
Click OK to exit after the operation of backup.

Figure 7-15-4
In addition, QC data backup, Calibration coefficients backup and Set data backup can be selected, all the
backup contents will be recovered if necessary.

● Changing the type of backup data are not available.

● The backup data cannot be modified and can be checked only.

7.16 Data Recovery

If data from sample database are damaged while the backup data do not be damaged, click Recovery in Figure
7-14-1, the following figure prompts:

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Figure 7-16-1
Select the path of backup, input File Name, and click open, the following figure prompts:

Figure 7-16-2
The following figure prompts after data recovery:

Figure 7-16-3
Click OK to exit, and the backup data will display in the database.

7.17 Help
Click “Help” in the menu to enter into Component Maintenance interface, and check the service condition of
the components, as following figure shows:

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Figure 7-17-1
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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Chapter 8 Service

8.1 Introduction
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 instrument damage.
● While working, the operator should take protective action, such as wearing protective gloves and
putting on labor clothes. Otherwise he/she may be infected when in contact with contaminated area or
liquid. When in contact with contaminated liquid, wash with water immediately and perform
sterilization.
● During cleaning and maintenance, pay attention to the parts holding liquid. The failure may lead to
danger.
● The instrument includes a laser device. Pay attention to the alarm labels during maintenance. Don’t
stare at the light beam directly or through optical devices.
● Improper maintenance may damage the instrument. The manual must be followed in maintenance.
● Please contact with the after-sales service department of the manufacturer Company if the problems
that are not explained in the instruction occur. The professional staff will provide maintenance
suggestions.

8.2 Maintenance Guide

8.2.1 Regular Maintenance
8.2.1.1 Daily
(1)QC should be conducted before daily analyzing. Refer to chapter 5 for QC operation.

(2)If the instrument is on for 24 hours, daily “Instrument Rinsing” should be conducted. Click in the
main interface and the instrument will execute instrument rinsing.
(3)If the instrument is on for 24 hours, the interval times of automatic rinse should be set: 10-200, and the
instrument will execute automatic rinse when the test times reaches the set test times.
(4)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).
8.2.1.2 Weekly
If normal shutdown operation is conducted every day, “Detergent Soaking”(WBC Pool, RBC Pool, DIFF Pool)
should be conducted weekly.(service-maintenance).
8.2.1.3 Monthly
Swab rinsing should be conducted monthly 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.

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8.2.2 Maintenance in Need

(1)If the sheath flow pool has been contaminated, conduct “Sheath Flow Pool Rinsing”.
(2)When the instrument has not been used for 2 weeks or more, replace the reagent with distilled water,
conduct “Rinse Pipeline” of “Maintenance”, and stop the distilled water, conduct “Empty Pipeline”, and place
the instrument at a clean place.
(3)When the instrument prompt “clog”, press “Remove” to conduct remove or conduct “Zap” and
“Backflush”.
(4)Carry out priming if it has not been used for a long time.
(5)The reliable results can be obtained under the condition of normal working environment and state.
(6)See the failure solution if other failure information is prompted..

8.3 System Status

System status is used to display the current status. System version, basic status and counter can be checked in
this interface.
8.3.1 System Version
Click “service”(Figure 8-3-1), and click “ ”in front of “System Version” to view the version of Software,
Mainboard, Control Board, Collection Board, Temperature Control Board, Laser Driver Board and
Mechanical.
For instance, if you select “Mainboard” from the left column, the screen will display the Software Version,
Upgrade Package Version and Hard ware Version as the Figure 8-3-2 shown:

Figure 8-3-1
The version of software and algorithm library are displayed:

Figure 8-3-2

The versions shown in the figure above is just for reference. The version No. will change as the program

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upgrades.
Select “Instrument Information” in its drop down menu, as Figure 8-3-3 shows:

Figure 8-3-3
It has been set before delivery. Therefore, it can only be checked.
8.3.2 Basic Status
Select “Basic Status” in Figure 8-3-1, the screen will display as shown in Figure 8-3-4:

Figure 8-3-4
Status explanation:
(1)Temperature: Display the real-time temperature of and the normal range of reaction pool, working
environment and laser to help the operator judge and locate faults. 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.

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(2)Pressure: Display the pressure reducing valve and normal pressure range.
(3)Voltage: Display 58V, 5V, voltage and the normal range of WBC aperture and of RBC aperture.
(4)Current: Display the normal range of and power adjust valve of laser current.

8.4 Mechanical Detect

Click in front of “Detect” in Figure 8-3-4, and select “Mechanical Detect”, as shown in Figure 8-4-1:

Figure 8-4-1

8.4.1 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, test motor, auto-loader feeding motor, auto-loader loading motor, auto-loader
unloading motor and auto-loader clamp & mix motor, sheath flow motor, and swab rinse motor. Click “Test”,
the result will be displayed on the screen (Succeed or Failed).
8.4.2 Valve Detection
Valve failure will lead to abnormal work of the instrument. Therefore, value detection is an important way to
solve pipeline failure.
Its operation is as follow:
Click the No. of the valve (No. of Figure 8-4-1 indicate valves), the instrument will conduct valve detection
automatically. Valve ON sound indicates normal valve.
8.4.3 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 after test to exit the interface.

8.5 System Maintenance

In order to protect the normal and accurate running of the instrument, the software provides a number of
maintenance functions.
8.5.1 Replacement/Priming
Execute background test after changing diluent and hemolytic agent to guarantee the background test in

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normal range, Click in front of “Maintain” in Figure 8-5-1, and select “Replace/Prime”, as Figure 8-5-1
shows:

Figure 8-5-1

Execute when first install the instrument or all reagent are used up. If single reagent need to
be changed, its operation is as follow:
(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 8-5-2

Click , pop up progress bar as shown in Figure 8-5-3:

Figure 8-5-3
After replacing FDO Lyse, the following box will pop up:

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Figure 8-5-4

Click to finish the replacement of FDO Lyse.

Click in Figure 8-5-2 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 , pop up progress bar “Replacing
FDT Lyse About 2 mins…”, After replacing FDT Lyse, “Operation finished” box will pop up, click
to finish the replacement.
Click 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 , pop up progress bar “Replacing
SLS-I Lyse About 2 mins…”, After replacing SLS-I Lyse, “Operation finished” box will pop up, click
to finish the replacement.
Click 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 , pop up progress bar “Replacing Diluent About 7
mins…”, After replacing Diluent, “Operation finished” box will pop up, click to finish the
replacement.
Click to cancel Diluent replacement.
(5)Detergent Replacement
When the detergent is polluted or it has been used up, and the whole bottle of the detergent need to be replaced,
click “Replace Cleanser”, “Yes/No Replace Cleanser” will pop up. Then click “OK”. The following box will
pop up:

Figure 8-5-5

“Operation Completed” will pop up after changing the detergent, click to finish the replacement.
If the operation needs to be canceled, click in the box of “Yes/No Replace Detergent” to cancel
detergent replacement.
(6)FDO Lyse Priming

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Click “Prime FDO Lyse” when FDO Lyse being emptied. The following box will pop up:

Figure 8-5-6

Click , as shown in Figure 8-5-7:

Figure 8-5-7
The following box will pop up after FDO Lyse priming.

Figure 8-5-8

Click 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.
Or: In the “fault information area”, clear the corresponding error message, the instrument automatically
conducts 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. Or: In
the “fault information area”, clear the corresponding error message, the instrument automatically conduct
Diluent priming when the software prompt Diluent insufficiency.
8.5.2 Rinsing
Select “Rinse” in Figure 8-5-1, as Figure 8-5-9 shows:

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Figure 8-5-9
(1)Conduct WBC pool rinsing when the background test value of WBC or HGB parameter is abnormal. Click
in Figure 8-5-9. As shown in Figure 8-5-10.

Figure 8-5-10

Click , progress bar will pop up as shown in Figure 8-5-11:

Figure 8-5-11

“Operation Complete” will pop up after WBC pool rinsing, click to finish the whole process.
Click in Figure 8-5-10 to cancel WBC pool rinsing.
(2)Conduct RBC pool rinsing when the background test value of RBC or PLT parameter is abnormal. Click
in Figure 8-5-9. Confirm box will pop up, click , progress bar will pop up.
“Operation Complete” will pop up after RBC pool rinsing, click to finish the whole process.
Click to cancel RBC pool rinsing in confirm box.
(3)Conduct DIFF pool rinsing when the WBC-diff parameter is abnormal. Click

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in Figure 8-5-9. Confirm box will pop up, click , progress bar will pop up. “Operation Complete”
will pop up after DIFF pool rinsing, click to finish the whole process.
Click to cancel DIFF pool rinsing in confirm box.
(4)In order to avoid sampling component contamination, swab rinsing should be conducted after one month’s
running.
Click in Figure 8-5-9. The confirm box will pop up, click , as Figure 8-5-12 shows:

Figure 8-5-12

“Operation Complete” will pop up after swab rinsing, click to finish the whole process.
Click ” 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 in Figure 8-5-9. Confirm box will pop up, click , progress bar will pop
up. “Operation Complete” will pop up after sheath pool rinsing, click to finish the whole process.
Click 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. “Eliminate
syringe pump bubble” should be conducted.
Click in Figure 8-5-9. Confirm box will pop up, click , progress
bar will pop up. “Operation Complete” will pop up after eliminating syringe pump bubble, click to
finish the whole process.
Click to cancel eliminating syringe pump bubble in confirm box.
8.5.3 Maintenance
Click “Maintain” in Figure 8-5-9, as shown in Figure 8-5-13.

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Figure 8-5-13
8.5.3.1 Emptying
In order to avoid liquid spill during pipeline maintenance, empty should be conducted first. Taken waste liquid
buffer bottle as an example:
(1)Click to empty the corresponding bottle and the pipeline. The following box will pop up.

Figure 8-5-14

Click in above figure to conduct empty WC. Progress bar will pop up. “Operation Complete” will
pop up after emptying WC, click to finish the whole process.
Click button on Figure 8-5-14 to cancel the emptying WC 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 the same as “Empty WC”.
(2)Once instrument will not be used for 3 days-2 weeks, click button on Figure 8-5-13, as
Figure 8-5-15 shows:

Figure 8-5-15

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After clicking “ ” button on above figure, the interface is shown below:

Figure 8-5-16

Take out reagent pipelines from reagent bottles and click “ ”, the progress bar of “Emptying
Pipeline About 6 Minutes…”will display. If the operation of emptying pipeline has been completed,
“Operation Complete” will pop up. After that, instrument should be placed at a clean place.
(3)Once instrument will not be used for 2 weeks, please replace reagent with distilled water, click
button on Figure 8-5-13, as Figure 8-5-17shows:

Figure 8-5-17

Click button on above figure, the progress bar of “Package Clean Pipe, About 33 Minutes…” will
display and if the operation of package clean pipe has been completed, “Operation Completed” will pop up.
After that, instrument should be placed at a clean place.
Then break-off distilled water and click button on Figure 8-5-13, as Figure 8-5-18 shows:

Figure 8-5-18

After clicking “ ” button on above figure, the interface is shown below:

Figure 8-5-19

Take out reagent pipelines from distilled water bottles and click “ ”, the progress bar of “Package
Clean Pipe, About 33 Minutes…” will display, and if the operation of package clean pipe has been completed,

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“Operation Completed” will pop up. After that, instrument should be placed at a clean place.
8.5.3.2 Aperture
Aperture clog remove, zap and backflush should be conducted in order to clear the debris in aperture.
Click button on Figure 8-5-13, the following box will pop up:

Figure 8-5-20

Click in above figure to clean the aperture through high-voltage direct current. The progress bar
will pop up meanwhile.
Clear the debris in aperture to prevent and remove RBC aperture clog.
Click , the confirm box will pop up, click to flush it. The progress bar will pop up
meanwhile.
Together with zap, the RBC aperture clog can be removed.
Click , the confirm box will pop up, click to zap and flush the aperture. The
progress bar will pop up meanwhile.
8.5.3.3 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.
(1)RBC Pool Soaking
RBC pool soaking should be conducted every other week, the operation is as follow:
Click “RBC Pool” in Figure 8-5-13, as Figure 8-5-21shows:

Figure 8-5-21

Click in above figure, as Figure 8-5-22 shows:

Figure 8-5-22

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The following box will pop up after soaking:

Figure 8-5-23
Click “Next” in Figure 8-5-23 to empty RBC pool, as the following figure shows:

Figure 8-5-24
Operation has been finished after emptying, as the following figure shows:

Figure 8-5-25

Click to finish the whole process.

(2)WBC Pool Soaking
WBC pool soaking should be conducted every other week, the operation is as follow:
Click in Figure 8-5-13, as Figure 8-5-26 shows:

Figure 8-5-26

Click in above figure, as Figure 8-5-27shows.

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Figure 8-5-27
Click “Next” to empty WBC pool, as the following figure shows:

Figure 8-5-28

Click to finish the whole process.

(3)DIFF Pool Soaking
DIFF pool soaking should be conducted every other week, the operation is as follow:
Click in Figure 8-5-13, as Figure 8-5-29 shows:

Figure 8-5-29

Click in above figure. As Figure 8-5-30 shows:

Figure 8-5-30
The interface will pop up after soaking, as Figure 8-5-31shows:

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Figure 8-5-31
Click “Next”, as the following figure shows:

Figure 8-5-32
“Operation Complete” will pop up after emptying.
8.5.4 Reagent Registration
Click “Reagent Register” in Figure 8-5-13, the screen display as Figure 8-5-33 shows:

Figure 8-5-33
8.5.4.1 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 8-5-33 to input the information according to the reagent package (click
if input incorrectly). Click after input.
Left times: Scan a barcode information for each, the remaining number will change in accordance with the
reagent in proportion to the size of bottle.

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8.5.4.2 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 succeed” and the scanned barcode, such as
after scanning SLS reagent.
8.5.4.3 Prompts for scanning failure
The following information will be prompted if scanning failed:

Figure 8-5-34
Re-input the information after checking if the above condition occurs. Contact with the manufacturerCompany
or its distributor for continuous failure.
The following box will pop up if the barcode has been used:

Figure 8-5-35
Change another bottle of reagent if the above condition happened.
8.5.4.4 Reagent Replacement
Conduct reagent replacement in “Replace/Prime” of “Maintain” after reagent registration

Do not stare at the scanning beam during instrument running to avoid eye injury.

8.6 Replacement of Wearing Components

8.6.1 Replace Syringe Pump
During tests, the reciprocating motion of the syringe pump causes a certain degree of wear and tear. When the
leakage occurs in the syringe pump, it should be replaced.
The pump positions are as follow:

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Figure 8-6-1

1 SLS Syringe Pump 2 FDO Syringe Pump 3 FDT Syringe Pump

4 swab rinsing pump 5 Diluent Pump 6 class test pump
Figure 8-6-2

8.6.2 Replacement of puncture probe

In testing, puncture will wear the point of puncture probe to same extent, suggest replacing puncture probe
when the number of testing sample accumulate to 30000. Proceed as follows:
Unscrew the two bolts which are used for fixing puncture needle, as Figure 8-6-3 shows:

Figure 8-6-3

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Pull puncture needle out vertically, as Figure 8-6-4 shows:

Swab

Figure 8-6-4
Unscrew upper joint of puncture needle and put the new puncture needle, as Figure 8-6-5 shows:

Figure 8-6-5
Insert the new puncture needle into swab vertically (as Figure 8-6-4 shows) Fix the bolt well.

8.7 System Log

Click “Log” in main interface, and select “Operation Log”, as Figure 8-7-1 shows:

Figure 8-7-1
The operator can also select “Error Log” and “Failure Log” in its drop-down list for checking.

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Chapter 9 Failure Handling

This chapter describes various types of possible failures, the reasons of the failures, and the solutions.

Testing the sample in case of failure may cause inaccurate result. If alarm prompts in the process of
testing, failure solution should be adopted first.

9.1 Introduction
Please refer to the following relative failure solutions if failures occur in the process of testing; please contact
with the after-sales service department of the manufacturer if the failures still exist.
Alarm information will be prompted in failure information area if failure occurs. Click the corresponding
failure, Figure 9-1-1 will pop up:

Figure 9-1-1 Failure information box

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 to clear the failure information. Click to close the dialogue.

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.
1.Click Clear to clear this failure.
[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.
1.Click Clear button to automatic clear failure.
[E00025] Swab clean motor error
2.Check whether swab motor failure occur.

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Alarm
Alarm Statement Solution
Code
1.Please check whether SLS Lyse is sufficient.
2.Please replace new reagent if there is no reagent and clear the
[E00005] SLS 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.
1.Click Clear to clear this failure.
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.
1.Click Clear to clear this failure.
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.
1.Click Clear to clear this failure.
2.If this failure remains. please check whether the heater 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
it if it is damaged.
4.Please check whether the overheat protector has been damaged.
replace it if it is damaged.
1.Click Clear to clear this failure.
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.
2.Click Clear to clear this failure.
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.
2.Click Clear to clear this failure.
3.If this failure remains. please replace temperature sensor.
1.Click Clear to clear this failure.
2.Please check the temperature sensor connection if this failure
Room temperature sensor
[E10009] remains.
disconnected.
3.Please check whether the temperature sensor has been
damaged. replace it if it is damaged.
1.Click Clear to clear this failure.
2.If this failure remains. please check whether the heater has
been damaged. replace it if it is damaged.
[E10001] WBC pool 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.
1.Click Clear to clear this failure.
2.If this failure remains. please check whether the heater has
been damaged. replace it if it is damaged.
[E10002] WBC pool temperature is too low. 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.

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Alarm
Alarm Statement Solution
Code
1.Click Clear to clear this failure.
2.Please check the temperature sensor connection if this failure
WBC pool temperature sensor
[E10003] remains.
disconnecting
3.Please check whether the temperature sensor has been
damaged. replace it if it is damaged.
1.Click Clear to clear this failure.
[E00010] Test Motor Error 2.Please check whether test motor failure occur if this failure
remains.
1.Click Clear to clear this failure.
[E00016] Test Motor Sensor Error 2.Please check whether test motor sensor failure occur if this
failure remains.
1.Click Clear button to automatic clear failure.
[E00023] Sheath motor error
2.Check whether sheath motor failure occur.
1.Click Clear button to automatic clear failure.
[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.
1.Click Clear to clear this failure.
[E00013] Sampling Motor Error
2.Please check the sampling motor if this failure remains.
1.Click Clear to clear this failure.
[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.
1.Click Clear to clear this failure.
[E00009] x-Axis Motor Error
2.Please check X axis motor if this failure remains.
1.Click Clear button to automatic clear failure.
[E00015] x-Axis Motor Sensor Error 2.If this failure still exist. check if failure occure on the sensor
of X-axis motor.
1.Click Clear to clear this failure.
[E00027] x-Axis Motor First Sensor Error
2.Please check X axis motor sensor 1 if this failure remains.
1.Click Clear to clear this failure.
[E00028] x-Axis Motor Second Sensor Error
2.Please check X axis motor sensor 2 if this failure remains.
1.Click Clear to clear this failure.
[E00029] x-Axis Motor Third Sensor Error
2.Please check X axis motor sensor 3 if this failure remains.

1.Click Clear to clear this failure.

[E00030] x-Axis Motor Fourth Sensor Error
2.Please check X axis motor sensor 4 if this failure remains.

1.Click Clear button to automatic clear failure.

[E00031] x-Axis Motor Fifth Sensor Error
2.Please check X axis motor sensor 5 if this failure remains.

1.Click Clear to clear this failure.

[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.Apply lube to motion bearing.

[E20013] STAT Loader Unavailable
2.Check K13 switch

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.

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Alarm
Alarm Statement Solution
Code
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.

1.Click Clear to clear this failure.

[E10011] 5V Voltage Exceeds Range
2.Please replace the circuit board if this failure unrestored.

1.Click Clear to clear this failure.

[E10013] 58V Voltage Exceeds Range
2.Please replace the circuit board if this failure remains.

1.Click Clear to clear this failure.

[E10015] Laser Current Exceeds Range
2.Please replace the circuit board if this failure remains.

1.Please check whether FDO Lyse is sufficient.

2.Please replace new reagent if there is no reagent and clear the
[E00006] FDO Lyse Empty
failure.
3.Check the floater switch if the reagent is sufficient.

1.Please check whether FDT Lyse is sufficient.

2.Please replace new reagent if there is no reagent and clear the
[E00007] FDT Lyse Empty
failure.
3.Check the floater switch if the reagent is sufficient.

1.Click Clear to clear this failure.

[E00012] Lyse Motor Error 2.Please check whether lyse agent motor failure occur if this
failure remains.

1.Click Clear to clear this failure.

[E00018] Lyse Motor Sensor Error
Tube rack feed to spacing sensor
[E20015]
error(posteroanterior)
2.Please check whether lyse agent motor sensor failure occur if
this failure remains.
1.Check if there is barrier on mobile pipeline. if any. remove it.
2.Please check K2 switch.

Tube rack feed to home position 1.Check if there is barrier on mobile pipeline. if any. remove it.
[E20001]
error(posteroanterior) 2.Applies lubed on mobile bearing.

1.Check if there is barrier on mobile pipeline. if any. remove

There is object on feeding
[E20017] foreign body.
position(left right)
2.Please check S2 optocoupler.
1.Check if there is barrier on mobile pipeline. if any. remove
Tube rack feeding position error(left
[E20003] foreign body.
right)
2.Applies lubed on mobile bearing.
1.Check if there is barrier on mobile pipeline. if any. remove
Tube rack feed to home position
[E20004] foreign body.
error(left right)
2.Please check K4 switch.

1.Check if there is barrier on mobile pipeline. if any. remove

Feeding motor have not moved(left
[E20016] foreign body.
right)
2.Applies lubed on mobile bearing.
Tube rack(left right) feed to left
[E20006] Please check K6 switch.
side microswitch error

Tube rack(left right) feed to right

[E20005] Please check K5 switch.
side microswitch error

1.Applies lubed on mobile bearing.

[E20008] Reset sensor of shake up motor error
2.Please check K7 switch

Shake up sensor of shake up motor 1.Applies lubed on mobile bearing.

[E20007]
error 2.Please check K8 switch

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Alarm
Alarm Statement Solution
Code
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.

1.Click Clear to clear this failure.

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.

[E20012] Left side tube racks are full. Check if tube racks in left side of sampler are full
[E20009] Tube rack has been moved Check K5, K6 switch
[E20002] Have no tube rack Check if tube racks in right side of sampler are full

1.Check if there is barrier on mobile pipeline. if any. remove

Tube racks have not been moved
[E20011] foreign body.
out.
2.Please check S2 optocoupler.

Move tube rack from home position 1.Apply lubed on mobile bearing.
[E20010]
error 2.Please check K9 switch
1.Click Clear to clear this failure.
[E00014] Y Axis Motor Sensor Error
2.Check whether Y axis motor sensor failure occur.
1.Please check S1 optocoupler.
[E20018] S1 optocoupler error.
2. Please check S1 optocoupler catch.

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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Chapter 10 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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Appendix A Network Communication Interface Protocol V1.1

A.1 Introduction
This protocol is used for information transmission between BF-Series Automatic Hematology Analyzer
(Model: BF-6880) and LIS. It is based on HL7 standard, HL7 version is 2.4.
A.2 Terms
MSH: each MSH head part is used for defining message purpose and aim, each message is made up by several
message segments. The first segment in each MSH is always the message head segment. It indicates the
sending and receiving program name and message type, and only message ID code, and following segment
structure is decided by message type. For example, a sample message send by OBR segment, one test result
information send by many OBX segment.
Segment: each message segment is made up by several groups 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)
Data field: segment made by several date fields. Different date fields are separated by list separator.
A.3 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.4 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.5 HL7 Attribute Table
Message segment in the protocol could be divided into required, optional, and repeatable.
A.5.1 MSH Definition Table

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MSH –message head: this message segment is required item, includes HL7 message basic information,
message separator value, message type and message coding method and so on, it is each HL7 message’s first
message segment.
Information Example:
MSH|^~\&|XXX|1234567890|||20100419104618||ORU^R01|361|P^S|2.4|||||CHN|UTF-8<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: 12345678
4 10 180
Code instrument code 90
Message created time (form
20110310
7 Send Time 14 26 As YYYY[MM[DD[HH[MM[SS]]]]]) ,
144704
Take system time value
Message type, form as “information
Message ORU^R0
9 7 7 type^event type”, value: ORU^R01(Sample)
Type 1
OUL^R21 (LJ/X, XB QC)
Message Message control ID is used for only mark one
10 20 20 361
Control ID message, value :PID
This field is used for decide on whether to
transact HL7 operation program’s(7th layer)
Transact transact rule definition information.
11 3 3 P^S
ID NO. Value:P^ message type(Type
Value:S-sample, LJ-LJ /X barQC, XB-XB
QC)
HL7
Agreements adopt HL7 version No. Value:
12 Version 3 60 2.4
2.4
NO.
Nation
17 3 3 Nation code mark, refer to HL 7 2.4 CHN
Code
Character ISO/IEC 10646-1-1993 International
18 10 10 UTF-8
Set character standard value: UTF-8

A.5.2 PID Definition Table

PID–patient information: this information segment is optional, used for patient sample transmission, including
patient case history number, name, age, gender etc.
Information Example:
PID||1234567890||| Wang San Qiang||| M<cr>
Serial HL7 Advice
Field Name Length Explanation Example
NO. Length
Case Patient ID, here used for patient case history 12345678
2 20 20
History no. NO. 90
Wang San
5 Name 50 250 Patient name
Qiang
8 Gender 10 1 Gender, showed as character string M

A.5.3 PV1 Definition Table

PV1 –patient in hospital information: This message segment is optional, use for patient sample transmission,
including patient department, bed NO., deliver doctor, examiner and so on.
Information Example:
PV1||| clinic^^235689|||| doctor Wang| Zhang San| Li Si<cr>

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Serial HL7 Advice

Field Name Length Explanation Example
NO. Length
Pointed patient ^^clinic
3 80 80 form as :department^^bed no.
position 235689
doctor
7 Deliver doctor 50 250 deliver doctor, character string
Wang
Zhang
8 Examiner 50 250 examiner, character string
San
9 Auditor 50 250 auditor, character string Li Si

A.5.4 OBR Definition Table

OBR –testing report list information: This information segment is optional, mainly include test report
information, including sample serial number, and scan No., tube rack No., deliver time and so on.
Information Example:
OBR||23|31C3F010230DFB03|0001^Count
Results||20071207080000|20071207160000|||||| |20071207083000||||2311|322<cr>
Serial HL7 Advice
Field Name Length Explanation Example
NO. Length
Sample Serial Sample number in testing
2 16 22 23
Number Document No. in LJ/X QC
31C3F01
Barcode ID in sample testing
3 Scan No. 32 22 0230DF
Lot No. in LJ/X QC
B03
Service ID symbol, used for sign on
0001^Co
Data Service different count result type.
4 200 200 unt
Type Idiographic value check the appendix
Results
OBR-4 message coding definition.
Sampling time in testing.
6 Sample Time 14 26
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
14 Delivery Time 14 26 delivery time.
Tube Rack
18 2 60
NO.
19 Tube NO. 2 60

A.5.5 OBX Definition Table

OBX –Test result: this message segment is repeatable item, mainly includes all test result parameter
information and sample test mode, analysis mode and reference group, etc.
Information Example:
OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00|L|||F<cr>
Serial HL7 Advice
Field Name Length Explanation Example
NO. Length
Used for mark different OBX message
1 Serial NO.ID 10 10 1
segment
Test result’s data type, value is “ST” ,
2 Data Type 3 3 ED
“NM” , “ED” , “IS” etc.
Test item mark. Form as “ID ^ Name”,
ID is test item mark, Name is test item
descript information. Each test item
serial no. value reference as appendix:
3 ID Symbol 250 250
identify coding definition. NOTE:ID
used for only make one testing
parameter, but name mainly for descript,
not for mark.

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Serial HL7 Advice

Field Name Length Explanation Example
NO. Length
Test result data, could be number,
test result,
character string, enumerate value, binary
chart data,
system etc, data specific value reference
5 notes, quality 65536 65536
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
12.463-3
7 Reference 20 60 reference range lower limit - upper limit
3.569
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.

A.5.6 OBR-4 Code Definition
Code Name Explanation OBR-4 Field
1001 Count Results sample count result 1001^ Count Results
1002 LJ/Xbar QC LJ/Xbar QC count result 1002^ LJ QC
1004 XB QC XB QC count result 1004^ XB QC

A.5.7 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
total white blood
2007 V_WBC NM 2007^V_WBC
cell
The number of
2008 V_BAS_c NM 2008^V_BAS_c
basophils
The number of
2009 V_NEU_c NM 2009^V_NEU_c
neutrophils
The number of
2010 V_EOS_c NM 2010^V_EOS_c
acidic granulocyte
The number of
2011 V_LYM_c NM 2011^V_LYM_c
lymphocytes
The number of
2012 V_MON_c NM 2012^V_MON_c
mononuclear cells
The percentage of
2013 V_BAS_p NM 2013^V_BAS_p
basophils
The percentage of
2014 V_NEU_p NM 2014^V_NEU_p
neutrophils
The percentage of
2015 V_EOS_p NM 2015^V_EOS_p
eosinophils
Lymphocyte
2016 V_LYM_p NM 2016^V_LYM_p
percentage
percentage of
2017 V_MON_p NM 2017^V_MON_p
Monocytes

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Code Name Explanation Value Type OBX-3 Field

The number of red
2018 V_RBC NM 2018^V_RBC
blood cells
2019 V_HGB Hemoglobin NM 2019^V_HGB
2020 V_MCV MCV NM 2020^V_MCV
Content of mean
2021 V_MCH corpuscular NM 2021^V_MCH
hemoglobin
Concentration of
2022 V_MCHC mean corpuscular NM 2022^V_MCHC
hemoglobin
Coefficient of
variation of red
2023 V_RDW_CV NM 2023^V_RDW_CV
blood cell
distribution width
Standard deviation
2024 V_RDW_SD of red blood cell NM 2024^V_RDW_SD
distribution width
2025 V_HCT Hematocrit NM 2025^V_HCT
2026 V_PLT Platelet count NM 2026^V_PLT
Mean platelet
2027 V_MPV NM 2027^V_MPV
volume
Platelet distribution
2028 V_PDW NM 2028^V_PDW
width
2029 V_PCT Platelet hematocrit NM 2029^V_PCT
Platelet -
2030 V_P_LCR NM 2030^V_P_LCR
macrophage ratio
RBC RBC scattergram 2101^RBC
2101 ED
Histogram.BIN BMP data Scattergram.BMP
PLT PLT scattergram 2102^PLT
2102 ED
Histogram.BIN BMP data Scattergram.BMP
WBC WBC scattergram 2103^WBC
2103 ED
Histogram.BIN BMP data Scattergram.BMP
DIFF DIFF scattergram 2034^DIFF
2034 ED
Scattergram.BMP BMP data Scattergram.BMP
WBCD WBCD scattergram 2104^WBCD
2104 ED
Scattergram.BMP BMP data Scattergram.BMP
How many quality
control in XB to
2079 XB_Num NM 2079^ XB_Num
generate a quality
control

A.5.8 Enumeration Type

Data Item Value
test mode 0-CBC 1- CBC+DIFF
0-auto-whole blood
1- microscale-whole blood (No.2 position)
analysis mode
2-close-whole blood (No.3 position)
3-close-prediluted (No.4 position)
0- normal 1- M 2- F 3- Child 4- baby 5- custom 1
Reference 6- custom 2 7- custom 3
8- custom 4 9- custom 5
L-J/X QC level 0- high 1- medium 2- low

A.5.9 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|||clinic^^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
code……||||||F<cr>
OBX|32|ED|2103^WBC Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
OBX|33|ED|2034^DIFF Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
OBX|34|ED|2104^WBC Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
<EB><CR>
(2)L-J/Xbar 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|28|ED|2034^DIFF Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
OBX|29|ED|2035^BASO Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
<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>

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OBX|9|NM|2021^V_MCH||4.63||||||F<cr>
OBX|10|NM|2022^V_MCHC||4.63||||||F<cr>
<EB><CR>

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Appendix B Report Designer User Guide

The report can be modified or created through report designer setting to design the ideal report format. We
offer the following two kinds of report template:
With no graph, paper can be saved
With graph, the default report format.
User can design the ideal report format through report designer.
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 contains multiple lines of text which allows containing 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 mouse after rectangular icon appears, as shown in
Figure B.2:

Figure B.2

Clipboard operation;

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Word wrap;

Cancel button;

OK button.

data included in the database includes patient information, sample test information, the corresponding
set of specific field will be detailed in the following chapter.
B.1.2 “Picture Frame”
Picture can be inserted in the report. The format of the picture is BMP, WMF, ICO.
Picture frame modification:
Click on the left of Report Edit Designer, click the 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

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(4)“Alignment” toolbar

The use of the button is same as other software.

B.2 Page Options
B.2.1 Paper
Set the page option for the current page of the report, select “File | Page Setting” in designer menu, or double
click blank area, as Figure B.4 shows:

Figure B.4
Select the paper size of current printer in the drop down list of paper size.
If the current printing support self-defined paper format, select "Self-defining", and then input the width and
length of the paper format.

Not all printer drive or printer support self-defining paper format (e.g. printer drive “HP LaserJet 6L”
does not support 76mm*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:

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Figure B.6
If the “Extend to the printer” option is selected, the page form of designer will not display the border area. All
regions of the page will be printed correctly. But the size is different in different printing.
If this option is canceled, and all margin set to be 0, then the margin will be automatically set to the selected
printer's maximum print area. When designed report switch from one printer to other 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 \ language\Sample: is patient sample report template; \ Print \language\ QC: is L-J QC report template.
Concrete operation: 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

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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.
(1)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”.
(2)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.
(3)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.
(4)Change size: select the object, press the up and down buttons of “high” or “width” to increase or decrease
the height or width.
(5)Change the font: Select the object, and then select the font size or bold, italic and so on.
(6)Undo: error happened during modification, undo operation for one or more times, the report will return back
to the style before modification.
(7)Save: press the “Save” button after all operation is completed.

If it is patient sample report, please store in the software installation directory \ Print \ language\Sample
folder; save quality control report into \ Print \language\ QC folder of software installation directory
(8)Open the system setting in data management software, select the modified or created report in print setting.

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Appendix C Manufacturer’s Warranty

Dear users:
Thank you for purchasing BF Series Automatic Hematology Analyzer (Model: BF-6880) of our company. We
can offer you the following service:
(1)Technical consultations provided at any time.
(2)Maintenance free of charge within a year from the day you purchase.
(3)Paid services in the following conditions:
a)The warranty period for the product has been expired.
b)Damage caused by accidents or improper use.
c)Damage caused by the operation that not according to the instruction manual or without our company’s
permission.
(4)With the development of technology, we will supply the service of update of BF Series Automatic
Hematology Analyzer (Model: BF-6880).

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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Appendix D 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 of Hematology Analyzer

Operation Consumption
Sleep(do not use the instrument for 2 or more hours) Diluent 26mL
Wake-up(use the instrument after sleep(within 3h)) Diluent 76mL
Wake-up(use the instrument after sleep(3—10h)) Diluent 90mL
Wake-up(use the instrument after sleep(over 10h)) Diluent 136mL
Detergent 14mL
Diluent 245mL
Manual rinse FDO Lyse 3mL
FDT Lyse 0.48mL
SLS-I Lyse 1mL
Detergent 6.8mL
Diluent 200mL
Automatic rinse(Set times: 10—200) FDO Lyse 3mL
FDT Lyse 0.48mL
SLS-I Lyse 1mL
Detergent 7.4mL
Diluent 185mL
Automatic rinse before sleep (Set times 10—600) FDO Lyse 3mL
FDT Lyse 0.48mL
SLS-I Lyse 1mL
Diluent 130mL
FDO Lyse 2mL
Power on
FDT Lyse 0.22mL
SLS-I Lyse 0.5mL
Diluent 170mL
Power off
Detergent 11mL

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Operation during running Consumption

Rinse WBC Pool Diluent 16mL
Rinse RBC Pool Diluent 12 mL
Rinse DIFF Pool Diluent 13 mL
Diluent 26mL
Rinse Swab
Detergent 2.6mL
Rinse Sheath Flow Pool Diluent 13 mL
Debubble Sample Injector Diluent 12 mL
Clog Remove Diluent 30 mL
Backflush Diluent 25 mL
Diluent 106mL
Detergent 3mL
Soaking WBC FDO Lyse 1.6mL
FDT Lyse 0.24mL
SLS-I Lyse 0.5mL
Diluent 106mL
Detergent 3mL
Soaking RBC FDO Lyse 1.6mL
FDT Lyse 0.24mL
SLS-I Lyse 0.5mL
Diluent 146mL
Detergent 7.5mL
Soaking DIFF FDO Lyse 3mL
FDT Lyse 0.48mL
SLS-I Lyse 1mL

Reagent consumption for priming and

Operation during running
rinsing
Prime FDO Lyse (after emptying) FDO Lyse 10mL
Prime FDT Lyse (after emptying) FDT Lyse 10mL
Prime SLS-I Lyse (after emptying) SLS-I Lyse 10mL
Diluent 285mL
FDO Lyse 2mL
Prime Diluent (after emptying)
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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Reagent consumption for priming and

Operation during running
rinsing
Diluent 46mL
FDT Lyse 13.24mL
Replace FDT Lyse
FDO Lyse 2mL
SLS-I Lyse 0.5mL
Diluent 56mL
SLS-I Lyse 13.5mL
Replace SLS-I Lyse
FDO Lyse 2mL
FDT Lyse 0.24mL
Diluent 26mL
Replace detergent
Detergent 4mL
Diluent 395mL
FDO Lyse 2mL
Replace diluent
FDT Lyse 0.24mL
SLS-I Lyse 0.5mL

Reagent consumption per test(without automatic rinse)

Diluent (not degassing) 53mL
Diluent (degassing) 47mL
SLS-I Lyse 0.5mL
FDO Lyse 2mL
FDT Lyse 0.24mL

D.4 Parameter Description

The parameter is obtained from histogram or scattergram.

Name Ab. Unit

Lymphocyte Percentage LYM% %

Monocyte Percentage MON% %

Neutrophil Percentage NEU% %

Basophil Percentage BAS% %

Eosinophil Percentage EOS% %

Mean RBC Volume MCV fL

Variation coefficient of RBC width distribution RDW-CV %

Standard deviation of RBC width distribution RDW-SD fL

Mean Platelet Volume MPV fL

Platelet Width Distribution PDW %

The parameter is obtained from calculation.

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Name Ab. Unit

Lymphocyte Number LYM% 109/L
Monocyte Number MON% 109/L
Neutrophil Number NEU% 109/L
Eosinophil Number BAS% 109/L
Basophil Number EOS% 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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Appendix E 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%
(20-100)×109/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%
RBC (3.50-5.50)×1012/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%;

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(2)WBC≤3.5%;
(3)HGB≤2.0%;
(4)PLT≤5.0%.
E.7 Throughput
The test speed of the analyzer is 80t/h.

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Appendix F Accessories List

The accessories list includes accessories, fittings, and consumables.
Replacement
Name Position Replacement Cycle Remarks
Guide
Sampling Syringe 3000h (continuous
Sampling Pump 8.6.1
Unit working)
Sheath Syringe 3000h (continuous
Testing Pump 8.6.1
Unit working)
BF-SLS-I Syringe Four linked 3000h (continuous
8.6.1
Pump Syringes Unit working)
BF-FDO Syringe Four linked 3000h (continuous
8.6.1
Pump Syringes Unit working)
BF-FDT Syringe Four linked 3000h (continuous
8.6.1
Pump Syringes Unit working)
BF-Diluent Syringe Four linked 3000h (continuous
8.6.1
Pump Syringes Unit working)
Swab Rinsing Six linked Syringes 3000h (continuous
8.6.1
Pump Unit working)
Puncture Probe Sampling Unit 100,000 samples 8.6.2
Inspected or replaced
Positive Pressure 3000h (continuous Contact the by the representative
Pump Unit
Pump working) service staff. from the manufacturer
or distributor only.
Inspected or replaced
3000h (continuous Contact the by the representative
Vacuum Pump Pump Unit
working) service staff. from the manufacturer
or distributor only.
Inspected or replaced
10,000 h (continuous Contact the by the representative
HGB Light Source Counting Unit
working) service staff. from the manufacturer
or distributor only.
Reagent Bottle Back of the
timely 2.3.1
Assembly analyzer
Detergent Back of the
timely 2.3.1
Assembly analyzer
Diluent Tank Cap Back of the
timely 2.3.1
Assembly analyzer

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