This manual is applicable for BF Series Automatic Hematology Analyzer (Model: BF-6800), hereinafter

called “instrument”.

Instructions

Dear users, thanks for choosing our BF Series Automatic Hematology Analyzer (Model: BF-6800).

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

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

Date of Manufacture: Refer to the label.

Use Limit: 7 years.

Version: REV. 01-2016.

Configuration No.: 001.

Note

● Instrument should be operated by medical inspection specialist, physician, nurse or lab assistant who are
specially trained.

● Maintenance plan is needed for hospitals and organizations. And the plan should be followed strictly.
Otherwise, instrument failure may occur.

● Instrument should be controlled by special software specified by the manufacturer. Other hardware or
software installation may affect the normal working of the instrument.

● For the reagent usage and storage method, refer to the reagent instructions. Make sure the reagents are used
within the shelf life in the reagent instructions.

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

● Pine oil and benzene cannot be used for outside cleaning, as it may cause color and shape change. Soft cloth
or gauze can be used for cleaning work. A little 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. Electromagnetism interference will affect the accuracy of the test
result.

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

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

● The instrument must be used in good grounding condition.

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

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

● It cannot be used in flammable and explosive environment.

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

● Non-professionals cannot open the left, right and upper cover of the instrument when the main power is ON.

● Make sure the instrument is used under the condition that is specified in user manual. In improper condition,
the instrument may not work well, the result may be inaccurate, instrument component may be damaged and
personal security is endangered.

● The protective measure may not be effective if the instrument is not operated according to the user manual.

Warning

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

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

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

● Avoid direct contact with the patient's blood.

● Disposable supplies cannot be reused.

Statement

The manufacturer has the final interpretation of the manual.

The manufacturer is responsible for the security, reliability and performance of the instrument after the
following requirements are met:

(1)Installation, debugging and repair are conducted by professionals.

(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

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

1.1 Overview .................................................................................................................................................... 1-1

1.2 Working Environment .............................................................................................................................. 1-1

1.3 Specifications ............................................................................................................................................. 1-1

1.4 Working Principle ..................................................................................................................................... 1-2

1.4.1 Sample Aspiration ....................................................................................................................................................... 1-2
1.4.2 Sample Dilution .......................................................................................................................................................... 1-2
1.4.3 WBC Testing .............................................................................................................................................................. 1-5
1.4.4 WBC Parameter .......................................................................................................................................................... 1-7
1.4.5 Hemoglobin Concentration Testing— Colorimetry .................................................................................................... 1-8
1.4.6 RBC / PLT Testing...................................................................................................................................................... 1-8
1.4.7 Rinsing ...................................................................................................................................................................... 1-10

1.5 Structure .................................................................................................................................................. 1-10

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

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

1.7 Symbol ...................................................................................................................................................... 1-11

Chapter2 Installation .................................................................................................................2-1

2.1 Installation Requirement .......................................................................................................................... 2-1

2.1.1 Space Requirement...................................................................................................................................................... 2-1
2.1.2 Power Requirement ..................................................................................................................................................... 2-1
2.1.3 Environmental Requirement ....................................................................................................................................... 2-1

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

2.2.1 Unpacking Procedures ................................................................................................................................................ 2-2
2.2.2 Transportation Method ................................................................................................................................................ 2-2

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

2.3.1 Hardware Installation .................................................................................................................................................. 2-2
2.3.2 Software Installation ................................................................................................................................................... 2-5

2.4 Software Un-installation ......................................................................................................................... 2-12

2.5 Software Login ........................................................................................................................................ 2-13

2.5.1 Login Software .......................................................................................................................................................... 2-13
2.5.2 Counting Interface..................................................................................................................................................... 2-15
2.5.3 Log Off ..................................................................................................................................................................... 2-17
2.5.4 Log Out ..................................................................................................................................................................... 2-18

Chapter3 Setting .........................................................................................................................3-1

3.1 Sample Information .................................................................................................................................. 3-1

3.2 Data Browse ............................................................................................................................................... 3-2

3.2.1 Edit Patient Information .............................................................................................................................................. 3-3

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3.3 Setting ......................................................................................................................................................... 3-7

3.3.1 Normal User ................................................................................................................................................................ 3-7
3.3.2 Administrator User .................................................................................................................................................... 3-14

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

4.1 Calibration Frequency .............................................................................................................................. 4-1

4.2 Calibration Method ................................................................................................................................... 4-1

4.2.1 Preparation before Calibration..................................................................................................................................... 4-1

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

4.3.1 Calibrator Reference Value Input ................................................................................................................................ 4-2
4.3.2 Calibration Counting ................................................................................................................................................... 4-2
4.3.3 Saving Calibration Result ............................................................................................................................................ 4-3
4.3.4 Calibration Result Deleting ......................................................................................................................................... 4-4
4.3.5 Calibration Coefficient Saving .................................................................................................................................... 4-4

4.4 Fresh Blood Calibration ............................................................................................................................ 4-5

4.4.1 Fresh Blood Preparation .............................................................................................................................................. 4-5
4.4.2 Fresh Blood Calibration .............................................................................................................................................. 4-5
4.4.3 Calibration Result Saving ............................................................................................................................................ 4-6
4.4.4 Calibration Result Deleting ......................................................................................................................................... 4-7
4.4.5 Calibration Coefficient Saving .................................................................................................................................... 4-7

4.5 Manual Calibration ................................................................................................................................... 4-7

4.6 Calibration History.................................................................................................................................... 4-7

Chapter5 Quality Control ......................................................................................................... 5-1

5.1 L-J QC ........................................................................................................................................................ 5-1

5.1.1 Quality Control Setting ............................................................................................................................................... 5-1
5.1.2 QC Counting ............................................................................................................................................................... 5-4
5.1.3 QC Result Review ....................................................................................................................................................... 5-7
5.1.4 QC List ...................................................................................................................................................................... 5-10

5.2 X QC ....................................................................................................................................................... 5-10

5.3 X-B QC ..................................................................................................................................................... 5-11

5.3.1 QC Setting ................................................................................................................................................................. 5-11
5.3.2 QC Counting ............................................................................................................................................................. 5-12
5.3.3 QC Graph Review ..................................................................................................................................................... 5-12
5.3.4 QC List Review ......................................................................................................................................................... 5-13

Chapter6 Normal Operation ..................................................................................................... 6-1

6.1 Preparation before Operation .................................................................................................................. 6-1

6.2 Daily QC ..................................................................................................................................................... 6-1

6.3 Sample Preparation ................................................................................................................................... 6-1

6.3.1 Whole Blood Sample Preparation ............................................................................................................................... 6-1
6.3.2 Add Diluent ................................................................................................................................................................. 6-2

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

6.4.1 Edit Sample Information ............................................................................................................................................. 6-3
6.4.2 Sample Analysis Steps ................................................................................................................................................ 6-4
6.4.3 Picture Check .............................................................................................................................................................. 6-7
6.4.4 Research Parameter Check .......................................................................................................................................... 6-7

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6.5 Close-Pre-diluted Sample Testing ............................................................................................................ 6-8

6.6 Auto-Whole Blood Mode ........................................................................................................................ 6-10

6.6.1 Bar code and sticking requirements .......................................................................................................................... 6-10
6.6.2 Edit Sample Information ........................................................................................................................................... 6-10
6.6.3 Change Test Mode .................................................................................................................................................... 6-11
6.6.4 Sample Analysis Steps .............................................................................................................................................. 6-12
6.6.5 Picture Check ............................................................................................................................................................ 6-13
6.6.6 Research Parameter Check ........................................................................................................................................ 6-13

6.7 STAT Sample Analysis ........................................................................................................................... 6-14

6.8 Parameter Alarm..................................................................................................................................... 6-16

6.8.1 Parameter Alarm Types............................................................................................................................................. 6-16
6.8.2 Differential or Abnormal Form Alarm ...................................................................................................................... 6-16

6.9 Sleeping .................................................................................................................................................... 6-17

6.10 Rinse and Clog Removal ....................................................................................................................... 6-17

6.11 Shutdown ............................................................................................................................................... 6-18

6.11.1 Shutdown Mainframe .............................................................................................................................................. 6-18
6.11.2 Exit Software........................................................................................................................................................... 6-18

Chapter7 Record Query ............................................................................................................7-1

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

7.2 Print ............................................................................................................................................................ 7-2

7.3 Query .......................................................................................................................................................... 7-3

7.3.1 Query According to Sample No. ................................................................................................................................. 7-4
7.3.2 Query According to ID Number .................................................................................................................................. 7-4
7.3.3 Query According to Test Mode and Date .................................................................................................................... 7-4
7.3.4 Query According to Case No. and Bed No. ................................................................................................................ 7-5
7.3.5 Query According to Name and Sex ............................................................................................................................. 7-5
7.3.6 Query According to Department and Deliver Doctor .................................................................................................. 7-5
7.3.7 Query According to Auditor ....................................................................................................................................... 7-5
7.3.8 Query According to Checker....................................................................................................................................... 7-5

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

7.4.1 CV Calculation............................................................................................................................................................ 7-5
7.4.2 Tendency Graph .......................................................................................................................................................... 7-6

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

7.6 Communication ......................................................................................................................................... 7-8

7.6.1 Sample Application ..................................................................................................................................................... 7-8

7.7 Delete .......................................................................................................................................................... 7-9

7.8 Export ......................................................................................................................................................... 7-9

7.9 Sample Adding ........................................................................................................................................ 7-10

7.10 Patient information modification ......................................................................................................... 7-10

7.11 Recheck .................................................................................................................................................. 7-10

7.12 Graph data query .................................................................................................................................. 7-11

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7.13 Result Comparing .................................................................................................................................. 7-11

7.13.1 Parameter Setting .................................................................................................................................................... 7-12
7.13.2 Comparison List ...................................................................................................................................................... 7-13
7.13.3 Tendency ................................................................................................................................................................. 7-13

7.14 Data Backup ........................................................................................................................................... 7-14

7.15 Data Recovery ........................................................................................................................................ 7-15

7.16 Help ......................................................................................................................................................... 7-16

Chapter8 Maintenance .............................................................................................................. 8-1

8.1 Maintenance Guide.................................................................................................................................... 8-1

8.1.1 Regular Maintenance ................................................................................................................................................... 8-1
8.1.2 Maintenance in Need ................................................................................................................................................... 8-1

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

8.2.1 System Version ........................................................................................................................................................... 8-2
8.2.2 Basic Status ................................................................................................................................................................. 8-3

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

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

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

8.4.1 Replacement / Priming ................................................................................................................................................ 8-4
8.4.2 Rinsing ........................................................................................................................................................................ 8-8
8.4.3 Maintenance ................................................................................................................................................................ 8-9
8.4.4 Reagent Registration ................................................................................................................................................. 8-15

8.5 Replacement of Wearing Components .................................................................................................. 8-16

8.5.1 Replace Syringe Pump .............................................................................................................................................. 8-16
8.5.2 Replacement of puncture probe ................................................................................................................................. 8-17

8.6 System Log ............................................................................................................................................... 8-18

Chapter9 Failure Handling ....................................................................................................... 9-1

9.1 Overview ..................................................................................................................................................... 9-1

9.2 Failure Information and Solution ............................................................................................................ 9-2

Chapter10 Instrument Transportation and Storage ............................................................ 10-1

10.1 Transportation ....................................................................................................................................... 10-1

10.2 Storage .................................................................................................................................................... 10-1

AppendixA Network Communication Interface Protocol V1.1 ............................................ A-1
AppendixB Report Designer User Guide ................................................................................ B-1
AppendixC Product Warranty ................................................................................................ C-1
AppendixD Product Description ............................................................................................. D-1
AppendixE Performance Index ............................................................................................... E-1
AppendixF Accessories List ..................................................................................................... F-1

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Chapter1 Brief Introduction

1.1 Overview
BF Series Automatic Hematology Analyzer (Model: BF-6800) is a highly integrated instrument with
high-capability. It characterize in accurate test result, easy operation, low consumable. The instrument can test
quantitative analysis result of 24 blood parameters and 10 research parameters. Instrument is connected with
computer to conduct operations.
The scope of the product: BF Series Automatic Hematology Analyzer is an in vitro diagnostic medical
instrument used by professionals for screening. It is used for testing red blood cell (RBC), platelet (PLT),
white blood cell (WBC) number and volume distribution and concentration of hemoglobin, and it offers
scattergram of white blood cell to help clinical diagnosis.

1.2 Working Environment

(1)Power Supply:100V-240V~, 50/60Hz;
(2)Environment Temperature: 18℃-30℃;
(3)Relative Humidity: ≤75%;
(4)Barometric Pressure: 75kPa ~ 106kPa;
(5)Altitude: ≤2000m;
(6)It should be protected from frost, condensation, water, rain, direct sunlight, etc.

1.3 Specifications
Model
Specifications
BF-6800

WBC, BAS#, NEU#, EOS#, LYM#, MON#, BAS%, NEU%, EOS%, LYM%,
Test Item MON%, RBC, HGB, MCV, MCH, MCHC, RDW-CV, RDW-SD, HCT, PLT,
MPV, PDW, PCT, P-LCR
Carry out five-part differential to WBC counting result; the instrument can test
Parameters 24 parameter, offer 1 scattergram and 4 histogram; it will alarm when the
abnormal condition of pathology and morphology occurs
Basic
Features Sample injection
Manual or automatic sample injection
method

Stored sample
The maximum test result of stored sample is 100000
volume

Sample barcode Identify automatically or input manually

Reagent type Four types in total, including a diluent and 3 types of lyse

Hemoglobin test Test hemoglobin utilizing the reagent without cyanide

Reagent
System
Reagent alarm It will alarm when there is no reagent or the reagent expires.

Reagent barcode External barcode reader or manual input

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Model
Specifications
BF-6800

WBC classification Cell chemical staining technology, sheath flow technology, optical analysis
principle method
Analysis
System
Counting method Utilize impedance technology for WBC counting

Computer
Computer and printer (optional)
configuration

Data
Interface RJ45 network interface
System

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

Weight 59kg

Whole
606mm×690mm×550mm
instrument Dimensions
(L×W×H)
system

Power 175VA

1.4 Working Principle

This instrument adopts electric impedance to test RBC, WBC/ Basophil, PLT number and volume distribution.
Test the hemoglobin concentration by using colorimetry. Adopting semiconductor laser flow cytometry to
obtain WBC 4-differential counting result. The results of other parameters are calculated upon the above
results.
1.4.1 Sample Aspiration
The instrument offers two sampling type: whole blood and pre-dilution mode.
(1)In whole blood mode, the instrument aspirates 20μL (CBC+DIFF mode) or 10μL (CBC mode) whole blood
sample.
(2)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 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.
1.4.2.1 Whole Blood Mode
(1)RBC/PLT Dilution Process

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Figure 1-4-1RBC/PLT Dilution Process

(2)WBC/Hemoglobin Dilution Process

Figure 1-4-2 WBC/Hemoglobin Dilution Process

(3)WBC Differential Dilution Process

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Whole Blood 8μL

FDO Lyse 1mL

FDT Lyse 0.24mL

4-differential dilution ratio of 1 : 156

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

Whole Blood Sample 20μL

Diluent 180μL

Dilution Ratio 1 : 10

FDO Lyse 1mL

Aspirate 40μL

FDT Lyse 0.24mL

4-differential Dilution Ratio 1 : 316

Figure 1-4-6 WBC Differential Dilution Process

1.4.3 WBC Testing

1.4.3.1 Laser Flow Cytometry
At the effect of a certain amount of reagent, the blood sample is pipetted into flow cell which is full of diluent.
Under the package of sheath which is formed by diluent, the single cell flow goes through the center of flow
cell, as shown in Figure 1-4-7:

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

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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
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
9
be obtained. Cell unit is 10 /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— Colorimetry
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.
Back ground transmission light int ensity
HGB = Cons tan t × Log10 ( )
Sample transmission light int ensity

This testing and calculation process will be finished by the instrument automatically, and the result will be
displayed in the counting interface.
1.4.6 RBC / PLT Testing
1.4.6.1 Impedance Method
This instrument adopts the electric impedance method to count red blood cell / platelet. RBC / platelet sample
flow into RBC test unit after twice dilution. The testing unit has a test aperture. A pair of positive and negative
electrodes exists beside the aperture. As the cells have the characteristic of a poor conductor, when the cell go
through the aperture under constant negative pressure, the DC resistance between the electrodes will change,
resulting in the formation of a pulse signal which is proportional to the cell size. A series of electrical pulse is
produced when the cell continuously go through the aperture. The number of pulses is equivalent to the cell
number through the aperture. The pulse amplitude is proportional to the cell size.
Compare the amplified electric pulse with channel voltage value corresponding to normal RBC/PLT size range.
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 RBC

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
PCL =
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 the puncture probe should be rinsed with diluents.
(2)Counting pool should be rinsed with diluents.
(3)Flow cell should be rinsed with diluents.

1.5 Structure
The instrument 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 Supply 3 Sensor Port 4 RJ45 Internet Access

Figure 1-5-3 Right Picture

1.6 External Devices

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

The Printer is optional.

1.7 Symbol
The following symbols include the symbols on the instrument, reagent, Control and Calibrator.

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Table 1-7-1

Symbol Meaning

BIOLOGICAL RISKS

LASER, DANGER SYMBOL

ALTERNATING CURRENT

IN VITRO DIAGNOSTIC MEDICAL DEVICE

BATCH CODE

USE BY

SERIAL NUMBER

DATE OF MANUFACTURE

PROTECTIVE GROUND

MANUFACTURER

THE DEVICE MEETS THE REQUIREMENTS OF DIRECTIVE ON IN VITRO

DIAGNOSTIC MEDICAL DEVICES

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

The symbol of the crossed out wheeled bin indicates that the product (electrical and
electronic equipment) should not be placed in municipal waste. Please check local
regulations for disposal of electronic products.

CAUTION, REFER TO THE ACCOMPANYING FILES OR MARK DETAILED

WARNING OR MATTERS NEEDING ATTENTION

CATALOGUE NUMBER

DO NOT TOUCH THE PUNCTURE PROBE WHEN THE INSTRUMENT IS

RUNNING.

“ON”(POWER)

“OFF”(POWER)

The above symbol information is included on the instrument, reagent strips, and Control.

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Chapter2 Installation
To ensure the normal working of the instrument after installation, the initial installation and set-up of the
instrument should be carried out by authorized personnel of the manufacturer.

Dedicated computer software should be used for controlling. It is recommended that the software and
database is not installed in system disk.

2.1 Installation Requirement

The space, power, environment should meet the requirement prior to instrument installation. The instrument
should be placed on level operating table. The operating table should bear at least 59kg.
2.1.1 Space Requirement
Ensure enough space for instrument maintenance.
(1)The space between the wall and the right & left side of the instrument ≥50cm.
(2)The space between the wall and the back side of the instrument≥50cm.
(3)The space between the front of the instrument and other equipment ≥ 100cm.
(4)Ensure enough space under and above the instrument for diluent, reagent and waste solution collecting
devices.

Do not install the instrument to the position where is far away from the fuse device.
2.1.2 Power Requirement
(1)Power supply: 100V-240V~, 50/60Hz;
(2)Power consumption: 175VA;
(3)Fuse specification: F4AL250V 5mm×20mm;
(4)Large load equipment like air conditioner, refrigerator, oven etc. should not be inserted in the same outlet.
A good grounding is must.
2.1.3 Environmental Requirement
(1)Environment Temperature: 18℃-30℃.
(2)Relative Humidity: ≤75%.
(3)Atmospheric Pressure: 75kPa-106kPa.
(4)The instrument should be protected from dust, mechanical vibration, significant noise and power
interference.
(5)It is recommended that the electromagnetic environment assessment of the laboratory should be conducted
prior to test.
(6)Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may
interfere with the proper working.
(7)It should be placed far from the constant ON-OFF electrical devices like brush-type motor, fluorescent
lamp.
(8)It should be placed far from heat and wind source, sunlight, brush-type motor, flickering fluorescent light
and electrical contact equipment.
(9)A well-ventilated place is a must; if necessary, a ventilation device can be used. Direct blowing should be
avoided, otherwise this may affect the test accuracy.

The result will be unreliable if the room temperature or power cannot meet the requirement. Or cause
instrument damage and endanger personal safety.

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2.2 Unpacking
2.2.1 Unpacking Procedures
Check the packaging of the instrument. Contact the manufacturer’s local distributor for any physical damage.
Unpack the box according to the following steps if there is no damage:
(1)Place the package in the direction of the arrow upward.
(2)Open the accessory box, mainframe box, check the items according to the packing list. Contact the
manufacturer’s local distributor for any shortage.
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 Installation Steps

The instrument should not be disassembled except normal maintenance.
2.3.1 Hardware Installation

1 Waste liquid inlet 2 Diluent inlet 3 FDT Lyse inlet 4 FDO Lyse inlet 5 SLS-I Lyse inlet 6 Detergent inlet
Figure 2-3-1 Instrumentand Reagent Connection
(1)Lyse, Diluent, Waste Liquid Connecting
Put the FDT Lyse bottle, FDO Lyse bottle, SLS-I Lyse bottle and Detergent bottle at the back of the
instrument. Connect according to Figure 2-3-1.
Put the Diluents barrel and waste liquid barrel under the working table. Connect according to Figure2-3-1.
(2)Liquid Level Sensor Connecting
Connect one end to “Float Sensor” 3 in Figure 1-5-3. Put the other end into the waste barrel, reagent bottle and
diluents according to the mark on the lead.

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● Waste liquid should be disposed of according to relevant local medical waste treatment regulations.
● The water discharge system should conform to the waste water discharge requirements for local
medical institutions.
(3)Computer Connecting
Connect “Net Port” of computer host with “Net Port” (RJ45) of right side the instrument (4 of Figure 1-5-3).
(4)Power Wire Connecting
Connect one end of supplied power line with the attaching plug on the right side of the instrument (2 of Figure
1-5-3). And connect the power line of host, display and printer.

● The socket connected with the power cable should be well-grounded.

● The power socket should be placed near the analyzer for an easy cut-off.
(5)Barcode Reader Connecting
Insert one end of the barcode reader into the “USB” of the computer host.

The light beam of the barcode reader may hurt eyes; therefore, staring should be avoided.
(6)Printer Connecting
Connect the printer and the computer host through data wire.
a)Whether the printer driver is installed.
b)Check the printing paper specification.

Screws will be used for fixing the puncture probe before delivery. Screws should be removed before
power on; otherwise, the puncture probe may be damaged, as the following figure shows:

Screw 1

Figure 2-3-2

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Spacer
Screw 2, 3

Figure 2-3-3

Screw 4

Figure 2-3-4

Nylon strap

Figure 2-3-5
After installation, screw 1, screw 2 of Figure 2-3-2, screw 2, 3 and spacer of 2-3-3 should be moved; screw 4

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of Figure 2-3-4, nylon strap(red) of Figure 2-3-5 otherwise, the puncture probe might be damaged after power
on.
2.3.2 Software Installation
The software has been installed by the manufacturer’s professionals before delivery. User should not uninstall
it except abnormity occurs. In case of a must-uninstall, please follow the following steps:
2.3.2.1 Operating Part
The software system is installed on the computer to constitute the operating part of the instrument. The
operating part consists of the host, 21.5 inch display, keyboard, mouse and printer.
Host: 32 bit English Windows 7 operating system, upper computer software environment installation package,
and upper computer software are installed.
Basic configuration: CPU clock speed≥2.8GHz, hard disk drive≥250G, memory≥2G, network interface (two
are better), and USB interfaces.
Display: Display each window, curve, and test data of the instrument software. Resolution≥1366×768.
Keyboard: Perform the instrument operation control and data input.
Mouse: Perform software operation.
Printer: Print test data and diagrams.
2.3.2.2 Computer Setting
(1)IP Setting
Click【Start】→【Control Panel】→【Network and Sharing Center】, select 【Change Adapter Settings】 from
the guide column on the left, open 【Local Connection】, select 【Properties】, and double-click 【Internet
Protocol Version 4(TCP/IPv4)】, as the following figure shows:

Figure 2-3-6
“XXX” in IP address “172.16.100.XXX” includes but not limited to the number as the above figure shows.
Any number within 【1-255】 except 138 can be input.

The instrument IP address is 172.16.100.138.

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

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Figure 2-3-7

2.3.2.3 Software Installation

Start “SetDoNet” after putting the software CD in the CD driver of the computer. “.NET Framework4.0”
installation assembly will pop up, as Figure 2-3-8 shows:

Figure 2-3-8
Click “Install” in the above figure, and the following figure will pop up:

Figure 2-3-9
Click “OK” in the above figure, after restart the Microsoft SQL Server 2005 can AutoRun Installation, as
Figure 2-3-10 shows:

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Figure 2-3-10
Click “Next” in the following pages until the page – Figure 2-3-11shows:

Figure 2-3-11
Continue to click “Next” until the installation completes. After install SQL2005, it will auto-run the
installation of VC++2008, as Figure 2-3-12 shows:

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Figure 2-3-12
VC++ installation completes, as Figure 2-3-13 shows:

Figure 2-3-13
At last, appearing the following tip illustrates the PC system environment is installed successfully. Then you
can install the upper computer software, as Figure 2-3-14 shows:

Figure 2-3-14

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When the above installation has been finished, run upper computer installation program, the installation
interface will pop up, as Figure 2-3-15 shows:

Figure 2-3-15
Click “Next” in above figure, 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 2-3-16 shows:

Figure 2-3-16
Click “Next” in above figure, the confirm interface will pop up, as Figure 2-3-17 shows:

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Figure 2-3-17
Click “Next” in above figure, a progress bar of installation will pop up, as Figure 2-3-18 shows.

Figure 2-3-18
After the installation progress, click “Next”, and the following figure pops up:

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Figure 2-3-19
Click “Close” in above figure to finish the installation of the software. The shortcut of the program will be
displayed on the table after installation.
If the upper computer is installed in the C:\, it is needed to modify the properties of the installation directory
after the upper computer installation steps complete. If the upper computer is installed in the other disks, the
properties do not need to be modified. Details are shown as follows: Right-click “Program File” and select
“Setup Properties”, as following Figure 2-3-20 shows:

Figure 2-3-20
Click “Security” button on the above figure, as following Figure 2-3-21 shows:

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Figure 2-3-21

Click【Edit...】button on the above figure, as following Figure 2-3-22 shows:

Figure 2-3-22

Click【Users】 key on above figure, and add security control permissions, that is to say, sign “ ” in
“Permissions for Users” line of “Full control”, then click【Apply】,【OK】key to save setting.

2.4 Software Un-installation

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

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Figure 2-4-1
Click “Yes” to finish the un-installation.

2.5 Software Login

Turn on the power switch of the instrument, login the application software.
2.5.1 Login Software

Double click the instrument application software icon , or click “Start”, find the software in “Program”
window, enter into “System Login” window, as Figure 2-5-1, 2-5-2 shows:

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:

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Figure 2-5-3

Input username, password in Figure 2-5-2, and then click “ ” to enter into “Component
Maintenance” interface as shown in Figure 2-5-4.

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

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Figure 2-5-6

● Background test is testing the interference upon particle and electricity.

● If the value of the first time background test exceeds the preset value, the second time background test
will be conducted. If tests are conducted for three times and background results exceed range, system
will prompt “Blank Error”.
● The high value, low value or abnormal result alarm will not be prompted by the instrument.

Click in Figure 2-5-6after self-test to enter into main interface, as Figure 2-5-7shows:

Main Menu Shortcut Status

Figure 2-5-7

2.5.2 Counting Interface

2.5.2.1 Main Menu
Test: For sample information input, sample test mode selection, test records query.
QC: L-J/X bar and X-B QC.
Calibration: Conducting calibration upon the instrument.
Setting: Set the instrument parameters.
Service: Test the status, maintain and detect the instrument.
Log: Keep the operation records.

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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:

: Indicates the printer is connected, printing is accessible.

: Printer is disconnected.

: Printer is working.

2.5.2.3 Public Information Area

Bottom of the counting interface is the public information area, as Figure 2-5-8shows:

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 Figure 2-5-9shows:

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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. 200represents the
rinsing interval(set in Auto clean Settings).
The manual rinsing method is as follow:

Click , as Figure 2-5-10shows:

Figure 2-5-10

Click , and the status bar displays “Rinsing instrument”. When carrying out the automatic rinse,
the main menu is shown as Figure 2-5-11. Only “Log” can be viewed. In the shortcut key area, only “Data
Browse” and “Data List” can be used. The user can edit patient information and view test results.

Figure 2-5-11

2.5.3 Log Off

Click in Figure 2-5-7.

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2.5.4 Log Out

Click in Figure 2-5-7to enter “Exit System” window, as Figure 2-5-12shows:

Figure 2-5-12

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

● Log off is recommended when the user is at rest. For avoiding non-user damage software or modify
the data. Periodical database backup is recommended to avoid data lose caused by unforeseen
circumstances.
● Input the initial user name and password in the first login. Set the user name, permission and
password in "Setting" after login for next login.

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Chapter3 Setting
The system parameter of the instrument has been set before delivery. The interface of the first power on is
system default. In order to meet the different needs of practical application, two permissions are provided(user
permission and administrator permission), the user can reset some parameters.

3.1 Sample Information

Click in Figure 2-5-7to enter the “Sample Information” window, as Figure 3-1-1 shows:

Figure 3-1-1
Analysis Mode: There are four modes. Microscale-Whole Blood and Close-pre-diluted are manual analysis
modes, and Auto Whole Blood is an automatic analysis mode. The sample auto-loader needs installing for the
three modes; otherwise, measurement cannot be done.
Sample No.: What entered here is the number of the next analytic sample. If the entered number repeats the
one in the sample bank of the current day, the following figure pops up:

Figure 3-1-2

● Sample No. with “-” is accessible. “.” is NOT accessible (“Sample No. Error” will be prompted if there
is “.”).
● The entered number of the sample to be tested cannot repeat the one of the already -tested or -edited
sample. Otherwise, the new record will replace the former one.
● Reference Range: Click the pull-down menu of “Reference”, general, man, woman, child, infant and
user-defined can be selected.

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Test Mode: There are two modes.【CBC】conduct counting without diff upon WBC, counting result includes
histogram and its parameter of WBC, RBC and PLT.【CBC+DIFF】conduct counting and differential upon
WBC, includes 24 parameters and scattergram, histogram.
Tube No. and Rack No.: When auto-whole blood mode is selected, auto-rack No. identification is not selected,
the rack No. and tube No. is on available status, as Figure 3-1-3 shows:

Figure 3-1-3
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
selected, as Figure 3-1-4 shows:

Figure 3-1-4
Sample No.: The sample No. input in this box is the next tested sample.

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. Using this
software, select Auto Whole Blood or Close-Whole Blood (No.3 position), by default, the instrument will
equalize pressure automatically.

3.2 Data Browse

Click of main interface shortcut and the following figure pops up:

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Figure 3-2-1

If the lock button is in the locked status, patient information can be edited or modified.

If the lock button is in the locked status, click it to make it unlocked.

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

Figure 3-2-2
(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

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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 No. in Figure 3-2-1 to edit patient information.
3.2.1.1 Sample Information
(1)Sample No.: When editing a sample number, if the number of the sample to be tested is the same as the
number, the test result will be saved in the sample results automatically.
(2)Bar code No.: Can be input manually or by scanning.
(3)Reference: Double click the input box behind “Reference” in Figure 3-2-1, the following box will pop up:

Figure 3-2-3
Input the corresponding 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
. The reference range of test items includes general, man, woman, child, newborn and 5 user
define.
The user can click the pull-down menu after “Reference” to make selection directly, as the following figure
shows:

Figure 3-2-4
(4)Sampling Time, deliver time: Select “Current Time” or “Empty” in the pull-down menu of “Sampling
Time”, “Deliver Time” in Figure 3-2-1. If “Current Time” is selected, click the corresponding time, manual
input is also available.

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3.2.1.2 Patient Information

(1)Case No.: Input the case No. in Figure 3-2-1.
(2)Name: Input the patient name directly.
(3)Sex: Double click the input box behind “Sex” in Figure 3-2-1, the following box will pop up:

Figure 3-2-5
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
.
The user can click the pull-down menu after “Sex” to make direct selection, as the figure below shows:

Figure 3-2-6
(4)Age: Input the patient age and double click the input box of age unit, the following box will pop up.

Figure 3-2-7
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

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.
The user can click the pull-down menu after “Age Unit” to make direct selection, as the figure below shows:

Figure 3-2-8
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,

There should be no “.” in age.

(5)Department: Input the department name in department box, double click “Department” input box, the
following box will pop up:

Figure 3-2-9
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
.
The user can click the pull-down menu after “Department” to make direct selection, as the figure below shows:

Figure 3-2-10
(6)Bed No.: Click the input box of “Bed No.” in Figure 3-2-1or input it directly.
(7)Deliver: Input it directly or double click the input box of “Deliver”, the following figure will pop up:

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Figure 3-2-11
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
.
The user can click the pull-down menu after “Delivery” to make direct selection, as the figure below shows:

Figure 3-2-12
(8)Remark: the remark information after test can be input (can be input directly).
Click “Save” button after the above information is entered. Click “Skip” to skip items. After entering the
current sample, click “Previous” and “Next” to continue to enter the patient information of other samples.

3.3 Setting
3.3.1 Normal User
Click “Setting” in main menu, as shown in Figure 3-3-1:

Figure 3-3-1

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3.3.1.1 Date Format Setting

There are three date formats:

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

following information will be displayed:

Figure 3-3-2

Press to save the changed date format. Press to exit the interface.

The changed date will be displayed in all positions with time(such as delivery time, sampling time, etc.).
3.3.1.2 Language Setting
Click “Language Setting” in Figure 3-3-1, as Figure 3-3-3 shows:

Figure 3-3-3

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

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Figure 3-3-4

Only the password can be modified when the user login as common user. Click in Figure
3-3-4, as Figure 3-3-5shows:

Figure 3-3-5

Input the new password and old password(the two passwords must be same), click to finish the
modification.

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

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Figure 3-3-6
Click the drop down box of corresponding item, select the validity according to the reagent instruction, press
, the tip “Saving Succeed” will pop up, click to finish the setting. Click
to exit the interface.

● Detergent and cleanser refer to the same reagent.

● The validity should be set again in the first time instrument using or after reagent, diluent
replacement. Expired reagent, diluent cannot be used.
3.3.1.5 QC Setting
Click “QC Setting” in Figure 3-3-6, as Figure 3-3-7, 3-3-8shows:

Figure 3-3-7

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

Figure 3-3-9
(1)Printer: Select the printer in its pull-down menu.

(2)Report Default Icon: Report page header icon can be set. Click , the dialog box of picture
path will pop up. Select the picture(picture size is 34×34, format can be BMP 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.
a)Headline: Delete the original headline and input new headline if headline need to be changed.
b)Page Footer: The page footer is user-defined, e.g. “This report is only responsible for the delivered

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sample.”

c)Print Report Format: Select the format in its pull-down menu. Click to preview the format.
(4)QC: The headline and print report format can be input in this unit.
a)Headline: Delete the original headline and input new headline to change it.

b)Print Report Format: Select the print format in its drop-down menu, and click to preview the
format.
(5)Report designer: User can design report format.
Refer to “Appendix B” for its using.
(6)Print Research Parameter: when “Print Research Parameter” is ticked, “Input microscopic examination
result” will display in the interface, as following figure shows:

Figure 3-3-10
(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.
3.3.1.7 Clogged aperture re-test switch
Click “Clogged aperture re-test switch” in Figure 3-3-11, as the following figure shows:

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Figure 3-3-11

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

Figure 3-3-12

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.
3.3.1.8Automatic sleep time
Click “Automatic sleep time” in Figure 3-3-11, the automatic sleep time of the instrument can be set, the range
is [10, 120], as Figure 3-3-13 shows:

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Figure 3-3-13

3.3.2 Administrator User

Input administrator username and password when login(Figure2-5-2), click “Setting”, as Figure 3-3-14shows,
the administrator can set the following items besides common user’s :

Admin is system default administrator username. Default password is 1. The password can be modified,
but cannot be deleted.

Figure 3-3-14
3.3.2.1 User Setting
Click “User Setting” in Figure 3-3-14, as Figure 3-3-15shows:

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Figure 3-3-15
(1)Add User:

Click in Figure 3-3-15, as Figure 3-3-16shows:

Figure 3-3-16

Input the username need to be added in the input box behind “Username”. Click to , which is in front of
“Audit Permission” if the user needs audit permission. To entitle “Admin Permissions” to added user,click
radio box before “Admin Permissions”(like this “ ”, and entitle “Audit Permissions” to added user
meanwhile) , and click to finish the user adding.

Click after username input if this user does not need audit permission or administrator.

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

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Figure 3-3-17

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

Figure 3-3-18

Click “ ”, the selected user will be deleted.

(3)Edit User:
Click the line of common user except admin in Figure 3-3-17, click , the interface is like
3-3-16:

Figure 3-3-19
The audit permission of common user can be edited again. Select the radio in front of “Audit Permission” to
give the permission to the user. Click radio box again it to cancel the permission.
Administrator permission can be edited, select administrator permission to get the administrator permission.
Cancel selection if administrator permission is not needed.
User’s admin permission can be reset, to entitle admin permission to user select radio box before【Admin

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permission】, to delete user’s audit permission cancel radio box before【Admin permission】, this user will
become general user.
(4)Modify Password:
The password of the administrator and common user can be modified by administrator.

Click the line needs to be modified in Figure 3-3-17, click , the interface is like Figure
3-3-20:

Figure 3-3-20

Input old password, new password, press to finish the operation.

3.3.2.2 Network Setting
Click “Network Setting” in Figure 3-3-17, and select “Device Setting” from the display link, as Figure
3-3-21shows:

Figure 3-3-21
The IP of hematology instrument cannot be modified by the user.
LIS Setting:
Select “LIS Setting” in Figure 3-3-21, as Figure 3-3-22shows:

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Figure 3-3-22
IP and port of LIS computer can be set. ON/OFF status of auto-communication can be selected.
The user can select whether to transmit “ON/OFF” status of results after aperture blockage.
3.3.2.3Unit Setting
Click “Unit Setting” in Figure 3-3-22, as Figure 3-3-23 shows:

Figure 3-3-23

Single-click the input box behind items and select the units. Click after input. Click
when “Saving Succeed” is prompted. Click “Default Value” to restore the setting when the unit
has been modified accidentally. “Default value setting succeed” indicates successful setting.
The units are as follow:

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Table 3-3-1

Parameter Unit Value Form Remark

109/L ***.** Default Unit

103/μL ***.**
WBC
102/μL ****.*

/nL ***.**

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

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

1012/L **.** Default Unit

106/μL **.**
RBC
104/ μL ****

/pL **.**

g/L *** Default Unit

HGB g/dL **.*

mmol/L **.*

fL ***.* Default Unit

MCV, RDW-SD
μm3 ***.*

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

103/μL ****
PLT
104/μL ***.*

/nL ****

fL **.* Default Unit

MPV
μm3 ***.*

PDW fL **.* Default Unit

% .*** Default Unit

PCT
mL/L *.**

P-LCR % **.* Default Unit

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The result form changes as the unit changes.

3.3.2.4Reference Value Setting
Reference range of general, man, woman, child, newborn and 5 user-defined are for selection, which is default
as “General”.
Single-click “Reference Setting” in Figure 3-3-23, as Figure 3-3-24shows:

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

Figure 3-3-25
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
succeeded” indicates successful setting.

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Figure 3-3-26
3.3.2.5Information Setting
(1)Department Information Setting:
Click “Information” in Figure 3-3-24, and select “Department Information” in the pull-down menu of
“Information Type”, as Figure 3-3-27shows:

Figure 3-3-27
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 need to be deleted in the department information list,
click .
(2)Doctor Information Setting:
Select the “Doctor Information” in the pull-down menu of “Information Type”, as Figure 3-3-28shows:

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Figure 3-3-28
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, and select the department of the doctor. Click .
b)Delete Doctor Information: Select the items need to be deleted in the doctor information list, click
.
(3)Reference Setting:
Select “Reference” from the pull-down menu of “Information Type”, as Figure 3-3-29shows:

Figure 3-3-29

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 3-3-30shows:

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

Figure 3-3-31
Select “Years Old”, “Month”, “Day” or “Hour” in the list of age unit. Only the commonly used age unit ID can
be changed here.
(6)Cost Category
Select “Cost Category” in the drop down list of “Information Type”, as following figure shows:

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Figure 3-3-32
a)Cost category information addition: input cost category name in the Name input box, input mnemonic in
the ID input box, and then click “Add”.
b)Cost category information deletion: select the item to be deleted in the cost category information list, and
then click “Delete”.
3.3.2.6Backup Setting
Select “Backup Setting” in Figure 3-3-31, as Figure 3-3-33shows:

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

Single-click . First select a folder for the backup file. The file suffix is *.dbk. Then click “Save”
button to save the setting.

The backup function is only for contents under “Setting”.

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(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.
When installing the software again, the user can recover the setting contents that have been backed up. Before
the recovery, select a saving path for the backup file. Then select a backup file according to the backup date
and time.
3.3.2.7Automatic Rinsing Setting
Click “Auto Cleaning Settings” in Figure 3-3-33:

Figure 3-3-34
Input automatic rinsing interval times in counting time (between10-200). The set number is 200 which means
automatic rinsing will be conducted after each 200 samples. The number will be 0 after rinsing.
(1)Input automatic rinsing interval times in the input box of counter “Count Times”(between10-200). The set
number is 100 in the above figure which means automatic rinsing will be conducted after each 100 samples.
The number will be 0 after rinsing.
(2)Input rinse DIFF pool interval times in the input box of rinse DIFF pool “Count Times” (between 10-600).
The set number is 10 in the above figure, which means when the test times is no less than 10,DIFF pool rinsing
will be conducted before sleep (The software displays “Rinsing the instrument…”), then the instrument will
enter into sleep mode (in case of not conducting shutdown and manual rinse of the instrument in the process of
test).
(3)Input rinse probe interval times in the input box of rinse probe “Count Times” (between 10-100).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 the puncture probe automatically. Only “Enable” is ticked, the function
of “rinse probe” is activated.
3.3.2.8 Abnormal Mark Setting
Click “Abnormal Mark Setting” in Figure 3-3-34, select “WBC”, as Figure 3-3-35 shows:

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Figure 3-3-35
Select “RBC/PLT”, as Figure 3-3-36shows:

Figure 3-3-36
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 cancel the
interface.

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Chapter4 Calibration
Calibration of the instrument is to ensure the accuracy of the results. Calibration must be carried out before
test.

4.1 Calibration Frequency

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

4.2 Calibration Method

The instrument offers three calibration methods: manual calibration, calibrator calibration and fresh blood
calibration. In calibrator calibration and fresh blood calibration, the relative calibration will be conducted
automatically by the instrument, and the calibration coefficient will be stored in “manual calibration” interface.
4.2.1 Preparation before Calibration
(1)Conduct the following checks before calibration. Contact manufacturer's after-sales service department for
any problem.
(2)Check the instrument and the reagent to ensure enough reagent to finish whole calibration process. If the
reagent is finished in the process of calibration, calibration should be conducted again.
(3)The Calibrator and reagent specified by the manufacturer should be used. The corresponding operation
should refer to the Calibrator and reagent instruction.

4.3 Calibration with Calibrator

Calibration with calibrator should be conducted under whole blood mode.

Click “Calibration” of above menu, and select “Calibrator Calibration” in , as Figure 4-3-1
shows:

Figure 4-3-1

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4.3.1 Calibrator Reference Value Input

Click the corresponding line of “Reference”, and input the value.
4.3.2 Calibration Counting
Click in Figure 4-3-1, the following interface will pop up:

Figure 4-3-2

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

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

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

The STAT loader will be available after sampling.

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Click , push the loader back, press the counting key of the instrument to test. If the
sample is not placed in position 3 of loader, the following box will pop up when pushing the loader back:

Figure 4-3-5
The loader will return to the available position when 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

4.3.3 Saving Calibration Result

After obtaining 3 or more counting results, the instrument will carry out CV and calibration coefficient
calculation and save the calibration coefficient result. Save after 5 times counting is recommended. As the
increase of calibration times, CV and calibration coefficient will be updated.
The following box will pop up if the results obtained beyond the scope.

Figure 4-3-7

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 result, if the calibration coefficient of
certain parameter is not within 75%-125%, click , the following box will pop up:

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Figure 4-3-8
Operator should check the reference value input, if the reference value input is correct, operator delete
calibration results, re-run the calibration count.
4.3.4 Calibration Result Deleting
If any abnormal result occurs, click “Test Result” on the left after test, × will be marked, indicating this result
is not counted during CV, mean, calibration coefficient calculation. If this result deletion is not needed after
test, click “Test Result” again(mark √ ), indicating this test result is valid.

If this result is invalid, click to delete the result.

4.3.5 Calibration Coefficient Saving
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 stored into calibration coefficient of “Manual
Calib.” interface. As Figure 4-3-10 shows:

Figure 4-3-10

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4.4 Fresh Blood Calibration

4.4.1 Fresh Blood Preparation
Use EDTA-K2 (1.5 mg/mL-2.2mg/mL blood) antifreeze vacuum tube to collect venous blood sample.
Mix the venous blood and anticoagulant immediately.
Prepare 3-5 copies of normal fresh blood by using the above method.
4.4.2 Fresh Blood Calibration

Fresh blood calibration needs to be conducted under “Whole Blood” testing mode.
Click “Fresh Blood Calibration” in Figure 4-3-1 to enter fresh blood calibration interface, as shown in Figure
4-4-1.

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

(3)Click in Figure 4-4-1, the following interface will pop up:

Figure 4-4-2

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Click in above interface. The close sample loader will be available, rotate the loader to make
position 3 align with 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 4-4-3
The results will be displayed after test.
4.4.3 Calibration Result Saving
(1)After obtaining 3 or more counting results, the instrument will carry out CV and calibration coefficient
calculation. 5 times counting is recommended. As the increase of calibration times, CV and calibration
coefficient will be updated.
(2)The instrument will carry out different process according to different results.
The following box will pop up if the results obtained beyond the scope.

Figure 4-4-4

Click to close the dialogue 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 result, if the calibration coefficient of
certain parameter is not within 75%-125%, click , the following box will pop up:

Figure 4-4-5
Operator should check the reference value input, if the reference value input is correct, operator delete
calibration results, re-run the calibration count.

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4.4.4 Calibration Result Deleting

If any abnormal result occurs, click “Test Result” on the left after test, × will be marked, indicating this result
is not counted during CV, mean, calibration coefficient calculation. If this result deletion is not needed after
test, click “Test Result” again(mark √ ), indicating this test result is valid.
If this result is invalid, click “Delete” to delete the result.
4.4.5 Calibration Coefficient Saving
Click in Figure 4-4-1 after 5 times counting, the following box will pop up.

Figure 4-4-6

Click to save the calibration coefficient. It will be stored into calibration coefficient of “Manual
Calibration” interface.

4.5 Manual Calibration

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

Figure 4-5-1
Click the corresponding line under “Calibration Coefficient” when the calibration coefficient needs adjustment,
and input the calibration coefficient, click , “Save succeed” will pop up, click .

4.6 Calibration History

The software registers information of each calibration.
Click “Calibration History” in Figure 4-5-1 to enter calibration log interface, as shown in Figure 4-6-1.

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Figure 4-6-1
The date, mode, calibration method and detail test value of latest 100 times calibration will be displayed. If
calibration counting is more than 100 times, the previous calibration result will be covered.
Query: Operator can query the calibration log according to log date, username and calibration method.

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Chapter5 Quality Control

Error may occur after long-term using which may lead to unreliable result. Quality control (QC) provides an
effective way to detect error. Only by familiar with the QC theory and practical operation method, the error
impact can be excluded.
In order to ensure the reliability of the result, the daily low, medium and high level control should be used to
conduct instrument control.
This instrument provides three QC methods: L-J QC, QC and X-B floating mean methods.

5.1 L-J QC
Under “L-J” QC, the operator can carry out quality control of 24 parameters. The instrument provides 12 QC
documents in order to save quality control parameter and result. Each quality control document can save up to
400 groups of quality control results. When the number of quality control is more than 400, the new QC result
will cover the old result.

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

Figure 5-1-1

5.1.1 Quality Control Setting

5.1.1.1 Lot No. Information Setting
QC information can be set through setting button. Click “Setting” above menu, as shown in Figure 5-1-2.

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Figure 5-1-2
(1)Select Document No.
Click the pull-down menu of “File No.” to select the file needs QC, the range is 1~12.
(2)QC Lot No. Input
Input the corresponding Control lot No. in the pull-down menu of “Lot No.” according to Control instruction.
(3)Validity Setting
Click the pull-down menu of “Validity” to input the validity according to the instruction.
(4)QC Level Selection
Select QC level (High, Mid, Low)in drop down menu of “Level”. Each lot No. corresponds to one level.

Click when above input is completed. “Saving Succeed” will pop up, and click
.
(5)Target Value, SD Input
Input the target value and SD according to the QC instruction.

The input lot No., validity should be the validity marked on the instruction.
5.1.1.2 Preset Value
The QC result in QC chart can be used to calculate Mean, SD and CV%. In QC edit, it can be used as preset
value.
(1)Deviation Limit Setting
If the display form of deviation limit or calculation method of deviation limit in pre-set value need to be
adjusted, following these steps:
Click “Setting” in main menu, select “QC Setting” in its left, as Figure 5-1-3 shows:

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Figure 5-1-3
Calculation method and range selection of deviation:
When “Absolute Value” calculation method is selected, the input deviation limit will be displayed in the form
of absolute value. “Range” will use two times the standard deviation (2SD) or 3 times the standard deviation
(3SD) as the deviation limit.
When “Percent” calculation method is selected, the input deviation limit will be displayed in the form of
percent. “Range” will use 2 times the variation coefficient (2CV) or 3 times the variation coefficient (3CV) as
the deviation limit.

Click in Figure 5-1-3, the preset value is obtained according to the set method, and it is taken as
the target value and deviation limit of current QC document. The corresponding position of the parameter will
be displayed in Figure 5-1-2.
(2)Delete Abnormal QC point
If abnormal QC point occurs, preset value can be obtained after abnormal point deleting. The operating steps
are as follow:

Click at the lower right in Figure 5-1-2, as Figure 5-1-4 shows:

Figure 5-1-4

Click of above figure, the screen will be switched into QC interface, as Figure 5-1-5 shows:

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Figure 5-1-5
a)If the first point on the right is an abnormal point, click it, the red cursor line is on the first point on the
right, click , the selected QC point will turn into Blue. To continue to delete other QC
points, click them, and the red cursor line will be on them. Click . When obtaining pre-set
values for calculation, deleted QC points are not included (blue QC points).
b)Click “Calculation” after the points are deleted, the screen will return to “Setting” interface, and the result
will be displayed.
c)If the valid QC point number is less than 3, click “Preset Value” button in Figure 5-1-2 or “Calculate”
button in Figure 5-1-5, Figure 5-1-6 will pop up:

Figure 5-1-6
d)If the above operation is found to be wrong, click the deleted point, and click “Add”, the blue point will
turn into red or green(normal point).

Valid QC points are taken as reference and deviation limit when taking preset value.
5.1.2 QC Counting
Click “QC count” in Figure 5-1-5 to enter QC counting interface, as shown in Figure 5-1-7.

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Figure 5-1-7
The specified Control of the manufacturer should be used to avoid QC result error.
See the instruction for the use of Control.
The result will not be reliable when the instrument failure occurs.
(1)QC Counting

Click in Figure 5-1-7, the following interface will pop up:

Figure 5-1-8

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

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Figure 5-1-9
Press the counting key of the instrument. The following box will pop up when pushing back the loader.

Figure 5-1-10
Start Sample Aspiration→Aspiration Complete→Testing DIFF→Testing RBC/WBC→Data Analysis will be
displayed in sequence.

The STAT loader will be available after sampling.

Click , push the loader back, press the counting key of the instrument to test.
If the sample is not placed in position 1 of loader, the following box will pop up when pushing the loader back:

Figure 5-1-11
The loader will return to the available position when 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.

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Figure 5-1-12
Test after right positioned.
If the result is lower than the lower limit of the software or higher than the display range, the following box
will pop up:

Figure 5-1-13

Click in above figure, this result will be deleted.

(2)QC Data Query
The stored QC result can be queried through button “Next” and “Previous” under “Position/Total Number”
after QC counting. If QC results are outside QC ranges, red is displayed in corresponding columns.
(3)QC Data Modification
After QC tests, to modify results, double-click them, and then make modification, click “Save” button to save
modified results.
(4)QC Data Printing
To print single QC results, click “Print” button to print current records.
(5)QC Data Deleting
To delete current QC results, click “Delete” button to delete current records.
5.1.3 QC Result Review
Click “QC Graph” in Figure 5-1-7 to enter review interface, as shown in Figure 5-1-14:

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Figure 5-1-14
(1)QC Graph Setting:

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

Figure 5-1-15
a)QC Item Setting:

Select the parameter name in Figure 5-1-15, click , only the selected parameter will be saved.
b)QC Item Moving:
If the parameters need to be moved, select the parameter need to be adjusted (the selected line is blue), click

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“Move Up”, “Move Down” to move the selected parameter.

(2)Explanation of QC result review interface:
If QC counting number is less than 3, the right side of QC chart will not display the QC result.
The abscissa indicates the QC counting number. The vertical axis indicates QC counting result.
Vertical line marked for the same set of counting data. For each parameter, its QC chart can display up to 400
points.
For each parameter, the three numbers on the left of the QC chart correspond to the three boundaries of QC
chart. From top to bottom, they represent the upper limit, target value and lower limit.
Upper limit: Control reference value + deviation limit
Target value: Control reference value
Lower limit: Control reference value - deviation limit
For each parameter, the three numbers on the right of the QC chart represent Mean, SD and CV% respectively.
(3)Point explanation of QC chart
The points are QC results, they are connected by lines.
“Green Point” indicates the QC result is within the range. “Red Point” indicates the QC result is not within the
range.
(4)If the point is not within the range, conduct the following steps.
Check the target value and deviation limit.
Check whether the background test is normal.
Conduct QC again if the above two points are normal. If abnormity remains, conduct QC counting after
calibration.
Contact after sales service department if abnormity remains after calibration.
(5)QC graph printing:

Click in Figure 5-1-14, if “Preview before print” is selected in print setting, preview can be
conducted before printing, as the following figure shows:

Figure 5-1-16

Connect the printer, 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.

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5.1.4 QC List
Different QC documents can be queried.
Click “QC List” in Figure 5-1-14, and select the QC document No. in the drop down menu of “File No.” to
enter the interface of Figure 5-1-17:

Figure 5-1-17
(1)Delete All: The operator can delete all QC results of current QC document.

Click in Figure 5-1-17, and Figure 5-1-18 is shown:

Figure 5-1-18
Click “Yes”, the interface will display “Delete Succeed”, which indicates that all QC results are deleted.
(2)Delete: The operator can delete some QC results of current QC document.

Select the QC data need to be deleted in Figure 5-1-17, click , as Figure 5-1-18 shows, click
“Yes”, the interface displays “Deleting Succeed”, which indicates the selected QC results are deleted.
(3)Print: The operator can print the QC counting result of current QC document.
(4)Export: The operator can export the QC counting result of current QC document.
(5)Communicate: The operator can transmit the QC counting result of current QC document to LIS.
(6)Import: the operator can import the QC counting result.

5.2 X QC
X QC: the mean value of two testing result will be one QC point in the QC chart.
The operation is same as “5.1 L-J QC”.

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5.3 X-B QC
X-B floating average method is proposed by Dr. Brian Bull. It monitors instrument performance through
monitoring stability of red blood cell parameters, such as MCV, MCH, MCHC, etc. It belongs to the quality
control without control. Together with the quality control with control, they all belong to instrument
performance monitoring method which can reflect instrument performance from different aspects. They are not
mutually replaceable. The X-B quality control is recommended when the daily sample is greater than 100 per
day. This quality control method requires the use of random sample; therefore, the classified sample is not
suitable. It offers the upper and lower limit to form a reference range. Observe the changing trend of result
within the reference range.
This instrument conducts X-B QC toward MCV, MCH, and MCHC. The sample number in each group can be
set as 20-200. The sample is come from normal counting result of the instrument, without classifying whole
blood and pre-dilution mode.
Calibration is needed before testing, because X-B reference value is obtained through analyzing a large
number of random samples.
5.3.1 QC Setting
The QC parameter needs to be set before X-B QC analysis.
(1)Click “Setting” in main menu, and select “QC Setting” in the left menu, open “X-B” interface, as Figure
5-3-1 shows:

Figure 5-3-1
Sample No. selected for each X-B point can be 20-200, the recommended number is 20.

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

(2)Click “QC” in above menu, and select “X-B” in , as Figure 5-3-2 shows:

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Figure 5-3-2
Target and Deviation Limit Input:
Click the target and deviation limit to input them.
Target: Reference of different area may be different, so the sample number should reach certain number (more
than 500), the mean should be taken as target of X-B QC.
Deviation Limit: 3%-5% of target should be taken as deviation limit.

Target and deviation limit cannot be blank.

(3)Click after setting, “Saving Succeed” will pop up, click .

5.3.2 QC Counting
The operator can conduct X-B QC upon normal counting result. The system will conduct X-B QC calculation
after 20-200 samples(Set according to the sample number/group ). Each X-B QC parameter will get a QC
point. It will be stored in X-B QC chart and X-B QC list.
5.3.3 QC Graph Review
Click “QC Graph” in Figure 5-3-2 to enter into X-B QC graph review interface, as shown in Figure 5-3-3.

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Figure 5-3-3
(1)QC graph explanation
The abscissa is the counting result number. The vertical axis is the result.
For each parameter, the three numbers on the left of the QC graph correspond to the three boundaries of QC
graph. From top to bottom, they represent the upper limit, target value and lower limit.
Upper limit: Control reference value + deviation limit
Target: Control reference value
Lower limit: Control reference value - deviation limit
For each parameter, the three numbers on the right of the QC graph represent Mean, SD, and CV%
respectively.
(2)Point of QC graph explanation
The points are QC results, they are connected by lines.
“Green Point” indicates the QC result is within the range. “Red Point” indicates the QC result is not within the
range.
(3)If the point is not within the range, conduct the following steps.
Check the target value and deviation limit.
Check whether the background test is normal.
Contact after sales service department if abnormity remains after calibration.
(4)QC data checking
The QC result can be checked through previous and next. Corresponding QC result will be displayed under the
parameter name. The position of the QC point and the total QC result number will be displayed in the form of
“Position/Total Number” at the lower left side of the interface.
5.3.4 QC List Review
Click QC list in Figure 5-3-3 to enter the X-B QC list review interface, as shown in Figure 5-3-4.

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Figure 5-3-4

(1)Delete: Click the QC data behind corresponding No., the line will turn blue, click , as
Figure 5-3-5 shows:

Figure 5-3-5
Click “Yes” in above figure, “Delete Succeed” will be displayed; the selected records will be deleted.

Reference range and deviation limit cannot be deleted.

(2)Delete All: Click , as Figure 5-3-6 shows:

Figure 5-3-6
Click “Yes” in above figure, “Delete Succeed” will be displayed, the all records will be deleted.

(3)Export: Click to enter Figure 5-3-7:

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Figure 5-3-7
Input the document name in the input box behind “Document Name”, and select the saving path, click

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 5-3-8
(5)Import: Click “Import”, the operator can import the QC counting result in the interface.

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Chapter6 Normal Operation

This chapter describes the whole process of daily operation from start to shut down. Focusing on the operation
process of whole blood sample and pre-dilution (Peripheral Blood) sample testing.
As shown in Figure 6-1-1:

Figure 6-1-1

6.1 Preparation before Operation

Check the instrument before using according to the following requirement.
(1)Check the waste barrel
To ensure daily empty before use.
(2)Check pipeline
Check the pipeline connected with reagent, waste barrel.
(3)Check the power supply
Check the connection between power plug and power socket of the instrument, and the computer.
(4)Check the printer
Check the connection between the computer and printer.
Check the printing paper and its installation.
(5)Check the barcode reader
Check the connection between the computer and the barcode reader.

6.2 Daily QC

QC analysis should be conducted every day before sample analyzing to ensure reliable result. Refer to
chapter 6 for operation.

6.3 Sample Preparation

6.3.1 Whole Blood Sample Preparation
(1)Use cleanEDTA-K2 (1.5mg/mL-2.2mg/mL blood) anti freezing vacuum tube to collect venous blood
sample for more than 1mL

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(2)Mix the venous blood with anticoagulant promptly.

● Use clean EDTA-K2 anti freezing vacuum blood collecting tube, silicified glass/plastic tube and 20μL
silica glass capillary.
● The sample that needs WBC differential or platelet counting should be stored at room temperature. It
should be used within 8 hour after collection.
● If 5 part of PLT, MCV, or WBC is not needed, the sample can be stored at 2 ℃ - 8 ℃ in refrigerator
for 24 hours. The stored sample should be used after placing at room temperature for at least 30
minutes.
● After a period of time of still placing, the sample should be mixed again before use.
6.3.2 Add Diluent

(1)Click in shortcut area, the screen display as Figure 6-3-1, 6-3-2 shows:

Figure 6-3-1

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

Figure 6-3-3
Press aspiration key, the diluent will be dispensed into the tube, the screen displays as Figure 6-3-4 shows:

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Figure 6-3-4
Move the tube after the close auto-loader is opened.
(3)And put 20 μL peripheral blood into the tube follow the tube wall. Mix them.
(4)Click “Cancel” in Figure 6-3-2, as Figure 6-3-5 shows:

Figure 6-3-5
Cancel diluent adding to finish preparation of diluted sample.
(5)If there are some samples need to be diluted after the first one, the interface will be displayed as Figure
6-3-2, Place a cleaning centrifuge tube on position 4 of closed injector, close the door of closed injector and
press aspirate sample key again, after that the second pre-diluted sample is completed.
Therestcanbedoneinthesamemanner and 20 pre-diluted samples can be prepared continuously at most.

● The operator can also use pipette to aspirate 180μL diluent and dispense it into the tube follow the
tube wall. And add 20 μL peripheral blood into the tube follow the tube wall. Mix them.
● When “pre-dilute” is selected, “Attention! 1:10 Dilute sample” will be prompted in sample
information.
● The diluent should be prepared in advance and protected from dust.
● After the mixing of peripheral blood and diluent, it should be placed for 3 minutes, and then remix
before use.
● The diluted sample should be used within 30 minutes.
● The sample should be re-mixed after placing for a period of time before use.
● The stability of the result on pre-dilution mode should be evaluated according to their own sample
number, sample collection method and technical level.

6.4 Sample Testing of Close-Whole Blood Mode

6.4.1 Edit Sample Information

Samples can be edited before analysis.

In the main interface, click , Figure 6-4-1 will pop up:

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Figure 6-4-1
When the lock button is in the locked status, patient information can be edited or modified.
(1)Sample Information: refer to 3.2.1.1.
(2)Patient Information: refer to 3.2.1.2.

● If the sample information of work list is blank, “Count according to sample registration list” cannot
be selected in Figure 6-4-2.

● If the patient information is edited after sample analysis, click after test.
6.4.2 Sample Analysis Steps
In the main interface, if the current mode is “Whole Blood”, testing can be carried out directly. Or switch the
current mode to “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 prompted after test is in accordance with general.

(1)In the main interface, press the , as shown in Figure 6-4-2:

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Figure 6-4-2
Change analysis mode and sample No.:
a)In “Analysis Mode”, Microscale-Whole Blood (No.2 position) or Close-Whole Blood (No.3 position).
b)The testing mode is “CBC” or “CBC+DIFF”.
“CBC” mode: conduct counting without WBC differential. The result includes 14 parameters and RBC,
PLT histogram.
“CBC+DIFF” mode: conduct counting and WBC differential. The result includes 24 parameters,
scattergram, histogram and 10 research parameters.
c)Sample No.: Select “Count according to sample registration list”, the sample No. cannot be changed. If
“Count according to sample registration list” is not selected, input the next sample No. according to needs.

● The maximum digit of sample No. is 15. “—” can be entered, but “.” cannot be; otherwise, the software
will prompt “No. error”.
● The entered number of the sample to be tested cannot repeat the number of the already -tested or
-edited sample; otherwise, the new test record will replace the former one.
● Select sample reference in pull-down menu of “Reference”, default as “General”.
● [Close Counting Method]:[Press Counting Key to test]or[Close STAT Loader to Test].
● [Do get barcode from scanner?]: In auto-whole blood testing, using internal barcode reader can be
selected, if use it, sample barcode in data browse list is barcode of test tube; if do not use it, sample
barcode in data browse list is edited barcode in sample register.

● Click in Figure 6-4-2 for saving.

(2)Select “Close-Whole Blood(No.3 Position)” for 2mL-vacuum tube. Select “Microscale-Whole Blood (No.2
Position)” for 0.5mL-vacuum tube. Click in Figure 6-4-2. The mode will switch to
“Close-Whole Blood” mode. And the close sample loader will be available, rotate the loader to make position
3 or 2 align with testing position (“Click” indicates right positioning), as Figure 6-4-3 shows:

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Figure 6-4-3
(3)On ready status(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, push the loader back. Press “Count” to test (If “Close STAT Loader to Test”
is selected, test will be started after pushing back the loader.). Result will be saved and displayed after test. The
STAT loader will be available after sample aspiration by the puncture probe.
(4)Place the next sample in position 2 or 3 of STAT loader, push the loader back. Press “Count” to test (If
“Close STAT Loader to Test” is selected, test will be started after pushing back the loader).

(5)Click Print in the main interface for report printing. Or click to enter into data list, press
. Select “current record” or “batch printing” to print reports.
(6)If the sample is placed in STAT loader not in accordance with the set position(select in Figure 6-4-2), the
following box will pop up when pushing back the loader.

Figure 6-4-4
The loader will return to the available position when 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 6-4-5
Test after right positioned.

● The disposable vacuum tube can be used 5 times at most, because the fragments from piercing may

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lead to inaccurate results.

● In the process of testing, the interface can be switched to “Picture” “Research Parameter/Microscopic
Examination Results” to browse the pictures or check the study parameters. But no operation can be
conducted. The data will be saved into the data review after test automatically.
● The result will be inaccurate if the temperature exceeds the normal working temperature range of the
instrument.
● If aperture is blocked during analysis, there will be ? behind the data, meanwhile “Aperture Is
clogged, perform clog removal or rinsing aperture.” will be prompted. And the result will be inaccurate,
thus test should be conducted after “clog remove”.
6.4.3 Picture Check

In the main interface, click , click “Picture” to check the pictures of the test results, as Figure
6-4-6 shows:

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

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Figure 6-4-7
Print research parameters:
Select “Print research parameters” in “Setup”→“Print Setting ”. In case that “Input microscopic examination
result” is not selected, whether input the microscopy result in “Research parameter/microscopic examination
result” interface or not, click“ ” in above figure to print the research parameter.

In case that “Input microscopic examination result” is selected, when printing research parameter, if
microscopic examination result is not input, “Please input microscopic examination result” will be
prompted.

6.5 Close-Pre-diluted Sample Testing

Check the working mode is “Pre-dilution Mode” in “Counting” interface; otherwise, switch the current mode
to “Pre-dilution” mode.

The pipeline will be rinsed after mode switching.

(1)Click in the main interface, the following box will pop up:

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Figure 6-5-1
Change analysis mode and sample No: Same as 6.4.

(2)After selection, click in Figure 6-5-1, the mode will switch to “Close-Prediluted” mode. And
the close sample loader will be available, rotate the loader to make position 4 align with testing
position(“Click” indicates right positioning), as Figure 6-5-2 shows:

Figure 6-5-2
(3)On ready status(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, push the loader back. Press “Count” to test (If “Close STAT Loader to Test” is
selected, test will be started after pushing back the loader.). Result will be saved and displayed after test. The
STAT loader will be available after sample aspiration by the puncture probe.
(4)Place the next sample in position 4 of STAT loader, push the loader back. Press “Count Key” to test (If
“Close STAT Loader to Test” is selected, test will be started after pushing back the loader.).

(5)Click in the main interface (browse interface) to print reports. Or click in

the main interface to enter the data list, edit patient information, press , and select “current
record” or “batch printing” to print reports.

● In the process of testing, “Graph” and “Research Parameter/Microscopic Examination Results” can

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be reviewed. 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.

6.6 Auto-Whole Blood Mode

6.6.1 Bar code and sticking requirements
(1)Bar code type: CODE128, CODE39.
(2)Bar code label dimensions:
CODE128: the number of digits should be no less than 4 but no more than 15;
CODE39: the number of digits should be no less than 4 but no more than 9.
(3)When cutting a barcode, the start blank and end blank should be no less than 3mm, as the following figure
shows:

Figure 6-6-1
(4)Requirements for sticking barcode label
a)The barcode should be flat and have no wrinkle.
b)The barcode should be labeled to the correct position. The upper edge of the barcode (including the start
blank) should be aligned with the lower edge of the tube cap. When putting tubes in a tube rack, make sure
all the barcode labels can be seen through the vertical groove opening of the tube rack.
6.6.2 Edit Sample Information

Sample can be edited before sample analysis.

In the main interface, click , and Figure 6-6-2 will pop up:

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Figure 6-6-2

If the lock button is in the locked status, patient information can be edited or modified.
(1)Sample Information: refer to 3.2.1.1;
(2)Patient Information: refer to 3.2.1.2.
6.6.3 Change Test Mode

(1)In the main interface, press , as shown in Figure 6-6-3:

Figure 6-6-3
(2)Change analysis mode and sample No:
a)In “Mode”, select “Auto Whole Blood”.
b)The testing mode is “CBC” or “CBC+DIFF”.
“CBC” mode: conduct counting without WBC differential. The result includes 14 parameters and RBC,
PLT histogram.

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“CBC+DIFF” mode: conduct counting and WBC differential. The result includes 24 parameters,
scattergram, histogram and 10 research parameters.
c)Sample No.: Select “Count according to sample registration list”, the sample No. cannot be changed. If
“Count according to sample registration list” is not selected, input the next sample No. according to needs.
d)Select sample reference in pull-down menu of “Reference”, default as “General”.
e)Rack No.: If “Automatic Rack No. Identification” is selected, test will be conducted from No.1. If
“Automatic Rack No. Identification” is not selected, test will be conducted from the input rack No.
f)[Do get barcode from scanner?]: In auto-whole blood testing, using internal barcode reader can be selected,
if use it, sample barcode in data browse list is barcode of test tube; if do not use it, sample barcode in data
browse list is edited barcode in sample register.

Click in Figure 6-6-3 for saving.

● The maximum digit of sample No. is 15. “—” can be entered, but “.” cannot be; otherwise, the
software will prompt “No. error”.
● The entered number of the sample to be tested cannot repeat the number of the already -tested or
-edited sample; otherwise, the new test record will replace the former one.
6.6.4 Sample Analysis Steps

● Before testing, set reference ranges for parameters in “Setting” interface; otherwise, incorrect alarms
may be prompted.
● Conduct sample testing after working mode selection, the default reference range is “General”. The
alarms prompted after testing is in accordance with general.
● The disposable vacuum tube can be used 5 times at most, because the fragments from piercing may
lead to inaccurate results.

(1)In the main interface, click , as Figure 6-6-4 shows:

Figure 6-6-4
On ready status(the green indicator is lighted), place the sample tubes on the racks accordingly, and place the

racks on the right side of the auto-loader(side with groove at the bottom). Click in Figure 6-6-3 or

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press “Count” key on the front cover of the instrument to start tests. The running status at the lower side of the
interface will be Start Sample Aspiration→Aspiration Complete→Testing DIFF→Testing RBC/WBC→Data
Analysis, meanwhile, the green indicator on the front cover of the instrument twinkling.
(2)The result of each sample will be saved to query interface. The racks will be loaded to the left side after all
tests of the rack is finished. The operator can take away the racks.

(3)Click in the main interface for report printing. Or click to enter into data list.
Click . Select “current report” or “batch printing” to print reports. Refer to Chapter 7 Record
Query for detailed operation.

Click in the main interface to enter the data list interface, edit patient information
according to sample numbers, or “Rack No.” and “Tube No.” and according to 3.2.1.1 and 3.2.1.2. After
the edition, click . Select “current report” or “batch printing” to print reports. Refer to
Chapter 7 Record Query for detailed operation.
6.6.5 Picture Check
Click “Picture” in Figure 6-6-4 to check the pictures of the test results, as Figure 6-6-5 shows:

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

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Figure 6-6-6
Test results of 10 research parameters can be queried.
Research parameter printing:
Select “Print research parameters” from “Setup”→“Print Setting”. Input the microscopy result in “Research
parameter/microscopic examination result” interface, and click “ ” in the above figure to
print the research parameter.

If microscopic examination results are not entered before research parameter printing, “Please enter
microscopic examination results” will be prompted.

6.7 STAT Sample Analysis

(1)During analyzing process, click in shortcut area if STAT sample analysis is needed. The
automatic sampling will stop till pierced sample is tested, and the mode will be switched to “Close” mode, and
Figure 6-7-1 will pop up:

Figure 6-7-1

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The STAT sample is default as start from 0-1:

Select sample position:
(2)Select “Close-Whole Blood(No.3 Position)” for 2mL vacuum tube. Select “Microscale-Whole Blood(No.2
Position)” for 0.5mL vacuum tube. Select “Close-Prediluted(No.4 Position)” for prediluted sample. Click
in Figure 6-7-1. And the close sample loader will be available, rotate the loader to make position
3, 2 or 4 align with testing position(“Click” indicates right positioning), as Figure 6-7-2 shows:

Figure 6-7-2

● STAT sample can only be tested on “Close-Whole Blood” or “Close-Pre-diluted” mode.

● The icon changed from to indicates a successful STAT insertion.

● STAT sample can only be tested by pressing the “Count” key.
(3)On STAT ready status(the yellow indicator is lighted), place the STAT sample in position 2,4 or 3 of STAT
loader, push the loader back. Press “Count” Key to test. The running status at the lower side of the interface
will be Start Sample Aspiration→Aspiration Complete→Testing DIFF→Testing RBC/WBC→Data Analysis,
meanwhile, the green indicator on the front cover of the instrument twinkling. Result will be saved after test.

(4)The loader will be available after test for the next. Click to stop STAT test. Switch the mode to
“Auto-Whole Blood” for routine sample test.

(5)Click in the main interface to enter into data list interface. Edit patient information according
to 3.2.1.1 and 3.2.1.2. Click , select “current record” or “batch printing” to print reports.
Refer to Chapter 7 Record Query for detail operation.
(6)If the sample is placed in STAT loader not in accordance with the set position(select in Figure 6-7-1), the
following box will pop up when pushing back the loader.

Figure 6-7-3
The loader will return to the available position when above box is prompted. Rotate it to the right position and

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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 6-7-4
Test after right positioned.

● In the process of testing, the interfaces can be reviewed. But no operation can be conducted. The data
will be saved into the data review after test automatically.
● The result will be inaccurate if the temperature exceeds the normal working temperature range of the
instrument.

6.8 Parameter Alarm

6.8.1 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 displayed with “?”, then the result is unreliable.
6.8.2 Differential or Abnormal Form Alarm
The instrument can prompt alarm according to the histogram and scattergram, as shown in Table 6-8-1:

Table 6-8-1
(1)WBC abnormity alarm information

Information Meaning Judging Standard

WBC scattergram abnormal ? WBC scattergram abnormal DIFF channel scattergram abnormal

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

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

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

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

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

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

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

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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
Nucleated red blood cell / platelet complete, red blood cell is on
aggregation immature stage or 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.

(3)RBC/HGB abnormal alarm information

Information Meaning Judging Standard

Abnormal RBC histogram
Abnormal RBC distribution Abnormal RBC histogram
distribution
RBC size is different. RBC size is different. RDW-SD>65or RDW-CV>20
Small RBC Smaller MCV MCV<70fL
Big RBC Bigger MCV MCV>110fL
RBC increase RBC increase RBC>6.5*1012/L
Anemia Anemia HGB<100g/L
Low pigment Low pigment MCHC<290g/L
Bimodality RBC bimodality distribution RBC histogram has two or more peaks.

(4)RBC/HGB unreliable alarm information

Information Meaning Judging Standard

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

(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.

6.9 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.

6.10 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:

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(1)Internal and external wall of puncture probe;

(2)Counting pool;
(3)Flow cell.
When the instrument prompts “Aperture Clog”, click “Remove Clog” in “Service-Maintenance”
interface(same as conducting “Zap” and “Back-flush” aperture).

6.11 Shutdown

In order to ensure the stability and accurate test result of the instrument, shutdown is required for the
instrument after 24 hours continuous working. The operator must follow these steps to turn off the
instrument.
Shutdown includes mainframe shutdown and software exit.
6.11.1 Shutdown Mainframe

Click “ ” in the main interface, as shown in Figure 6-11-1:

Figure 6-11-1

Click , above figure will pop up. After shutdown liquid aspirating, “Shutdown the instrument”
will pop up, the instrument will conduct pipe and counting pool rinsing and soaking. The following box will
pop up after the previous two steps:

Figure 6-11-2
(1)Switch to “O” on the right of the instrument to finish shutdown.
(2)Empty the waste solution container after shutdown.

Click “Restart” in Figure 6-11-2 if more tests are needed.

6.11.2 Exit Software

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

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Figure 6-11-3

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

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Chapter7 Record Query

The instrument will store the result into database automatically after each test. The maximum storage capacity
is 100000 sample results. The operator can query the sample result, scattergram and histogram of the database.
The result will be covered if the storage number reaches the maximum.

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

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

7.1 Record Selection

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

“Condition” in its pull-down menu , as Figure 7-1-2 shows:

Figure 7-1-2

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

● The input sample position should within the range of sample lib, otherwise, “Input range error, please
input again” will be prompted.
● If “Cancel Selection” is selected in pull-down menu, the selection will be canceled.

7.2 Print
The sample results can be printed in sample query interface.
(1)Single sample Printing:

Click in Figure 7-1-1, and a pull-down menu will pop up. If “Preview or not before
printing” is selected in “Print Setting”, the following figure is shown.

Figure 7-2-1

Click in above figure to print the report.

After printing the selected report, the current sample print status is , switch to the counting
interface, the print status on the printed report is “printed”.

(2)Bulk Print: Click in Figure 7-1-1. Select “Bulk print” from the popping-up pull-down
menu, and Figure 7-2-2 is shown:

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Figure 7-2-2
Select the test date of the report, and input the start and end sample number. If “Audited” is selected and
“Preview or not before printing” is selected, the report can be previewed, as the following figure shows:

Figure 7-2-3
The selected & audited samples will be printed. If “Audited” is not selected, all selected samples will be
printed.

After printing the selected report, the current sample print status is , switch to the counting
interface, the print status on the printed report is “printed”.

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

“Condition” in its pull-down menu , as shown in Figure 7-3-1.

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Figure 7-3-1
Users can select different query conditions to query, including: sample No., barcode No., test time, test mode,
case No., bed No., name, gender, and department, deliver doctor, auditor and tester. The results can be queried
according to one condition or multi-condition.
7.3.1 Query According to Sample No.
Input the sample No. in the box behind “Sample No.” need to be queried in Figure 7-3-1, if the input sample
No. is “1”, click , the sample results with No. “1” will be displayed, as Figure 7-3-2 shows:

Figure 7-3-2

7.3.2 Query According to ID Number

Input a barcode to be queried in the box behind “Bar code” in Figure 7-3-1, and click . The
results will be displayed.
7.3.3 Query According to Test Mode and Date
In Figure 7-3-1, select the start date and end date of the samples need to be queried in the pull-down menu
behind test time, and select the corresponding “Test Mode” and “Analysis Mode”, click , the
records will be displayed.

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7.3.4 Query According to Case No. and Bed No.

Input the case number or bed number to be queried in the box behind “Case No.” or “Bed No.” in Figure 7-3-1.
Click , and the results will be displayed.
7.3.5 Query According to Name and Sex
Input the patient name to be queried and select the sex of the patient in Figure 7-3-1. Click , and
the results will be displayed.
7.3.6 Query According to Department and Deliver Doctor
Select the department of the sample in the pull-down menu behind “Department”, and select the deliver doctor
of the sample in the pull-down menu behind “Deliver Doctor” need to be queried in Figure 7-3-1, click
, the results will be displayed.
7.3.7 Query According to Auditor
Select the auditor of the sample in the pull-down menu behind “Auditor” need to be queried in Figure 7-3-1,
click , the results will be displayed.
7.3.8 Query According to Checker
Select the checker of the sample in the pull-down menu behind “Checker” need to be queried in Figure 7-3-1,
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.
Take sample No. as an example:
If sample with No. 11, 211, 311 exist, when “Perfect Match”is selected, the input query No. is 11, only sample
No.11 can be queried.11, 211, 311 will be displayed when “Perfect Match” is not selected.

7.4 CV and Tendency Graph

7.4.1 CV Calculation
Users can select 3 or more records to calculate the CV, Mean and SD. If the selected record number is less
than 3, the interface will be:

Figure 7-4-1
In Figure 7-1-1, click numbers in front of record lines, and there will be (√) at number positions of record lines.
After number selection (number of selected records must be more than or equal to 3), click the right button of
the mouse, and a dialogue will pop up; select “CV” and Figure 7-4-2 will be shown:

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Figure 7-4-2
The repeatability of the results is invalid if the any parameter of the selected sample is invalid.

Click in above figure to exit the interface.

● If a certain parameter of a selected sample is invalid, then the repeatability index of the parameter is
invalid.
● Wait-for-test samples cannot be selected to calculate CV; otherwise “Cannot calculate CV value!” will
be prompted.
7.4.2 Tendency Graph
In Figure 7-4-2, click “Tendency Graph” button, and Figure 7-4-3 is shown:

Figure 7-4-3

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Parameter setting in tendency graph:

Click “Setting” button in Figure 7-4-3, and the following figure pops up:

Figure 7-4-4

The user can set parameter items to be queried according to needs: in front of parameters means
parameters are selected. The user can click Button “To top”, “Up”, “Down”, and “To bottom” to adjust the
positions for parameters in the tendency graph. After the setting, click “OK” to exit.
Deviation limit setting of tendency graph:
Click the input box under “Deviation Limit” on the right of Figure 7-4-3.The user can enter a deviation limit
corresponding to the parameter on the left. After the edition, click “Save” button.

7.5 Bulk Audit

The user can conduct bulk audit in result query, click in Figure 7-1-1, as Figure 7-5-1
shows:

Figure 7-5-1

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Select the test date from the pull-down menu of “Test Date”, and input the start sample number and end
sample number, click , the auditor information of audited sample result will be displayed behind
auditor.

7.6 Communication

Click list review interface, and select proper records from list , the
interface is as follows if Input Range is selected.

Figure 7-6-1

Click after input. Data transmission can be conducted. The interface is as follow.

Figure 7-6-2

Manual data transmission is forbidden during counting.

7.6.1 Sample Application

Select “Sample Application” from pull-down menu “ ”, and the following figure pops up:

Figure 7-6-3
Enter a start and end sample number, and click “OK” button. Patient information can be applied from LIS
system. The applied patient information is saved in the record of a edited sample to be tested or a tested sample

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in the software.

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

menu , as Figure 7-7-1 shows:

Figure 7-7-1

Click in above figure to delete the records.

7.8 Export
The exported data can be saved.

Click in Figure 7-3-2, select the data needs to be exported in its pull-down

menu , as the following figure shows:

Figure 7-8-1

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

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Figure 7-8-2
Indicates successful data export.

The exported file should be saved in EXCEL form.

7.9 Sample Adding

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

7.10 Patient information modification

From Figure 7-3-2, select a record, and modify information at the bottom of the patient information area. Click
“Enter” or “Save” to save the information.

7.11 Recheck
If the user doubts the accuracy of a certain test result, select the record and click the right button of the mouse
from Figure 7-1-1. Then Figure 7-11-1 pops up:

Figure 7-11-1
Click “Recheck” in Figure 7-11-1. The status changes from “Tested” to “Recheck”. Carry out tests according
to the routine testing method. The status displays “Testing ...”. After tests, the status turns into “Tested”,
namely, the recheck is finished.
In the process of recheck, the status of counting interface is the same with what of result query.

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7.12 Graph data query

The user can query a single record through the graph mode. From Figure 7-1-1, select the line of the sample
record and double-click it, and Figure 7-12-1 is shown:

Figure 7-12-1
The positions and sum of the results in the sample database are displayed at the bottom of the interface in the
form of “Position/Sum”.
The current test data can be saved, deleted, audited, and printed in this interface.

7.13 Result Comparing

In the main interface, click “Test” and then click “Review”. The following figure pops up:

Figure 7-13-1
In Figure 7-13-1, click “Result Comparing”. Figure 7-13-2 pops up:

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Figure 7-13-2

7.13.1 Parameter Setting

The user can set the displayed parameters after query, and also can move the display position of the parameters.
Click “Setting” in Figure 7-13-2, and Figure 7-13-3 pops up:

Figure 7-13-3
(1)Item Setting
From Figure 7-13-3, select parameter names to be displayed. And “ ” appears in check boxes. Click “OK”
button. After query, only results of selected parameters will be displayed.
(2)Item Moving Up, Down
To order the parameter that will be queried, select it (the line turns blue) and click “Up” or “Down” button to
move it.

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7.13.2 Comparison List

Enter case number “111” in Figure 7-13-2. To avoid entering a name, select a test time, and click “Query”.
Input name “111” and do not input case No. in Figure 7-13-2. Select a test time, and click “Query”.

Figure 7-13-4
All the test results whose case numbers including “111” corresponding to the test time can be queried.
Input name and case No. in Figure 7-13-2, and select “Exact Search”. Select a test time, and click “Query”.
Then the user can query the result corresponding to the test time, name and case number.
7.13.3 Tendency
After query according to the method above, click “Tendency”, and select a corresponding parameter from the
“Parameter” pull-down menu. Figure 7-13-5 pops up:

Figure 7-13-5
If “WBC” is selected, WBC tendency can be queried; The lower part displays the WBC value of each record.

By default, “ ”is ticked in the compare list, users can check the corresponding graph in the tendency

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interface. If only one item is ticked, select corresponding parameter in the tendency interface, and only one
point will display in the graph.

7.14 Data Backup

Click “Backup” in Figure 7-13-1, and then Figure 7-14-1 pops up:

Figure 7-14-1
There are 3 types of test data backup:
(1)If the radio button “Selected Records” is clicked, selected records will be backed up. “Selected Records” are
those with “ ” in the data list.
(2)If the radio button “All Records” is selected, all the records in the database will be backed up.
(3)If the radio button “Enter Range” is selected, after selecting the test date range, records within the range will
be backed up.
After selection, click “OK”, and Figure 7-14-2 shows:

Figure 7-14-2
Select a backup path, enter the name of the file to be backed up, and click “Save”. Figure 7-14-3 is shown:

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Figure 7-14-3
After backup, the following figure pops up. Click “OK” to exit.

Figure 7-14-4
In addition, QC data backup, Calibration coefficients backup and Set data backup can be selected, all the
backup contents will be recovered if necessary.

● It's forbidden to select the type of a backup file

● The contents of the backup data cannot be modified; only can be queried.

7.15 Data Recovery

When the data saved in the database is damaged but the backup data is intact. Click “Recover” in Figure
7-13-1, and then Figure 7-15-1 pops up:

Figure 7-15-1
Select the file path and file name, click “Open” and Figure 7-15-2 pops up:

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Figure 7-15-2
After data recovery, Figure 7-15-3 pops up:

Figure 7-15-3
Click “OK” to exit. Backup data are displayed in the database.

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

Figure 7-16-1
All the buttons should be dimmed. If any button is highlighted, the corresponding test item should be checked
or the corresponding component should be replaced. Please contact the after-sales service of the manufacturer
and ask the professionals for maintenance advice.

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Chapter8 Maintenance
In order to ensure the normal running of the instrument, routine maintenance is required. The instrument will
prompt the user to conduct maintenance after testing a certain number of sample or a continuous working
period. The service menu in the instrument offers routine maintenance methods and failure solutions, but users
should make their own maintenance plan according to daily sample number, operating environment, running
time, etc. to reduce the impact of various factors and ensure the safe, stable and effective running of the
instrument.

● Don’t spill reagents, samples, waste liquid, etc over the mechanical or electrical parts of the
instrument, so as to avoid damage.
● While working, the operator should tack protective action, such as wearing protective gloves and
putting on labor clothes; otherwise, he/she may be infected when in contact with the contaminated area
and liquid. In case of contact with contaminated liquid, wash with water immediately and perform
sterilization.
● During cleaning and maintenance, pay attention to the parts holding liquid; the failure of them may
lead to danger.
● The instrument includes a laser device. The operator should pay attention to the related warning
labels during maintenance. Do not stare at the light beam directly or through optical devices.
● Improper maintenance may damage the instrument. The manual must be followed in maintenance.
● Contact the manufacturer's after-sales service department for unclear answers of the manual.

8.1 Maintenance Guide

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

If the instrument is on a 24-hour run, users should conduct “Rinse Instrument” daily. Click the key
in the shortcut key area of the main interface to conduct the rinse operation. Or users can set the numbers of
automatic rinse intervals in “Setting”: 10-200. When a certain number of tests have been conducted, the
instrument will rinse itself automatically.
If the instrument is on for 24 hours, daily “WBC Pool Rinsing”, “RBC Pool Rinsing”, “DIFF Pool Rinsing”
operation should be conducted(service-maintenance-rinsing).
(2)Every week:
If normal shutdown operation is conducted every day, “Detergent Soaking”(WBC Pool, RBC Pool, DIFF Pool)
should be conducted every week.(service-maintenance) .
(3)Every month:
Swab rinsing should be conducted each month if daily shutdown is conducted(Service-Maintenance-Rinsing).

For the first use of the 10mL detergent, take the 10mL detergent bottle out of the package, open the
cover, take out the rubber plug and pour 5mL -10mL detergent (about half a bottle of detergent) from
the 500mL detergent bottle to the 10mL detergent bottle. Then open the front door of the instrument,
put the 10mL detergent bottle in the reagent bottle slot which is in the middle of the counting unit (with
black cover). For the continuous use, when changing 500mL detergent, the 10mL detergent also needs to
be changed in accordance with the above steps.
8.1.2 Maintenance in Need
(1)If the counting pool has been contaminated, conduct “Counting Pool Rinsing”.
(2)When the instrument has not been used for 2 weeks or more, replace the reagent with distilled water,

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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” failure, press “Remove” to conduct manual remove or conduct “Zap”
and “Back-flush”.
(4)Carry out priming if it has not been used for a long time.
(5)The instrument will prompt “Soaking with Detergent” if the set counting number of software has been
conducted.
(6)The reliable results can be obtained under the condition of normal working environment and state.
(7)See the failure solution if other failure information is prompted.

8.2 System Status

System status is used to display the current status. Basic status, system version can be checked in this interface.
8.2.1 System Version
Click “Service” (Figure 8-2-1), and then click in front of System Version, in the left tree to view the
version information of software, mainboard, collection board, temperature control board, laser driver board
and mechanism.
If “Mainboard” is selected, the version of software, hardware and update package will be displayed. See figure
8-2-2.

Figure 8-2-1
Version number of software and algorithm library is displayed.
Select Mainboard, as Figure 8-2-2 shows:

Figure 8-2-2

The version numbers shown in the figures above are just for reference, because the software version will
change as the system upgrades.
Select “Instrument Information” in its drop down menu, as Figure 8-2-3 shows:

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Figure 8-2-3
The information has been set before delivery. You can just view. Modification is not allowed.

Version No. of above figure is only for reference.

8.2.2 Basic Status
Select “Basic Status” in Figure 8-2-2, the screen display as Figure 8-2-4:

Figure 8-2-4
Status explanation:
(1)Temperature: Real-time temperature of reaction pool, working environment and laser, and also the normal
range. When the room temperature is lower than 15℃ and is higher than the set lowest temperature or the
room temperature is higher than 30℃ and is lower than the set highest temperature, “the room temperature is
out of the normal range” will prompt at the bottom right of the software interface.
(2)Pressure: Pressure of pressure reducing valve and normal pressure range.
(3)Voltage: Display 58V, 5V, voltage of WBC aperture, RBC aperture and normal range.

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(4)Current: Display the normal range and power adjust valve of laser current.

8.3 Mechanical Detect

Click in front of “Detect” in Figure 8-2-4, and select “Mechanical Detect”, as shown in Figure 8-3-1:

Figure 8-3-1
8.3.1 Motor Detect
When some moving parts failure occurs, motor detection can be conducted to judge the failure. The following
motors detection has been set in this program: Y axis motor, X axis motor, diluent motor, lyse motor, whole
blood aspiration motor, test motor, auto-loader feeding motor, auto-loader loading motor, auto-loader
unloading motor and auto-loader clamp & mix motor. Click “Test”, the result will be displayed on the
screen(Succeed or Failed).
8.3.2 Valve Detection
Valve failure will lead to abnormal work of the instrument. Therefore, valve detection is an important way to
solve pipeline failure.
Its operation is as follow:
Click the No. of the valve(No. of Figure 8-3-1 indicate valves), the instrument will conduct valve detection
automatically. Valve ON sound indicates normal valve.
8.3.3 Pump Detection
Click “Positive Pressure” or “Negative Pressure” to check the pump voltage.

● Valve detection and voltage detection cannot be conducted at the same time.

● Click after test to exit the interface.

8.4 System Maintenance

In order to protect the normal and accurate running of the instrument, the software provides a number of
maintenance functions.
8.4.1 Replacement / Priming
Click in front of “Maintain” in Figure 8-3-1, and select “Replace/Prime”, as Figure 8-4-1 shows:

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Figure 8-4-1

Reagent replacement and filling can be conducted. Users can conduct when installing the
instrument for the first time or after the reagents are used up. To replace a single reagent, see the following
operation:
(1)FDO Lyse Replacement:
Click “Replace FDO Lyse” when bubble exits in FDO Lyse pipeline, or FDO reagent is polluted, or FDO
reagent has been used up.

Figure 8-4-2

Click , pop up progress bar as shown in Figure 8-4-3:

Figure 8-4-3
After replacing FDO Lyse, the following box will pop up:

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Figure 8-4-4

Click to finish the replacement of FDO Lyse.

Click in Figure 8-4-2 to cancel FDO Lyse replacement.

(2)FDT Lyse Replacement:
Click “Replace FDT Lyse” when bubble exits in FDT Lyse pipeline, or FDT reagent is polluted, or FDT
reagent has been used up. The confirm interface will pop up. Click , 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:
Click “Replace Cleanser” when bubble exits in Detergent pipeline, or Detergent is polluted, or Detergent has
been used up. The confirm interface will pop up. Click , as shown in following Figure:

Figure 8-4-5

Conduct Detergent replacement. After replacement, “Operation finished” box will pop up, click

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to finish the replacement.

Click to cancel Detergent replacement.

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

Figure 8-4-6

Click , as shown in Figure 8-4-6:

Figure 8-4-7
The following box will pop up after FDO Lyse priming.

Figure 8-4-8

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 Lyse” 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
conduct SLS-I Lyse priming when the software prompt SLS-I Lyse insufficiency.
(9)Diluent Priming:

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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.
8.4.2 Rinsing
Select “Rinse” in Figure 8-4-1, as Figure 8-4-9 shows:

Figure 8-4-9
(1)Conduct WBC pool rinsing when the background test value of WBC or HGB parameter is abnormal. Click
Rinse WBC in Figure 8-4-9, as shown in Figure 8-4-10.

Figure 8-4-10

Click , progress bar will pop up as shown in Figure 8-4-11:

Figure 8-4-11

“Operation Complete” will pop up after WBC pool rinsing, click to finish the whole process.

Click in Figure 8-4-10 to cancel WBC pool rinsing.

(2)Conduct RBC pool rinsing when the background test value of RBC or PLT parameter is abnormal. Click

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Rinse RBC in Figure 8-4-9. 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 Rinse DIFF in

Figure 8-4-9. 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 “Rinse Swab” in Figure 8-4-9. The confirm box will pop up, click , as Figure 8-4-12 shows:

Figure 8-4-12
Place the detergent used for probe rinsing under puncture probe and press sample aspiration key. Progress bar
will pop up. “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 Rinse Sheath Flow Pool in Figure 8-4-9. Confirm box will pop up, click , progress bar will
pop up. “Operation Complete” will pop up after 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. “De-bubble Sample Pump” should be conducted.

Click “De-bubble Sample Pump” in Figure 8-4-9. Confirm box will pop up, click , progress bar
will pop up. “Operation Complete” will pop up after de-bubble, click to finish the whole
process.

Click to cancel de-bubble in confirm box.

8.4.3 Maintenance
Click “Maintain” in Figure 8-4-9, as shown in Figure 8-4-13.

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Figure 8-4-13
8.4.3.1 Emptying
In order to avoid liquid spill during pipeline maintenance, empty should be conducted first. Taken waste liquid
buffer bottle as an example:
(1)Click Empty WC to empty the corresponding bottle and the pipeline. The following box will pop up.

Figure 8-4-14

Click in above figure to conduct empty WC. Progress bar will pop up. “Operation Complete”
will pop up after emptying, click to finish the whole process.

Click to cancel the emptying in confirm box.

The operation of “Empty PK”, “Empty WBC Pool”, “Empty RBC Pool”, “Empty DIFF Pool”, “Empty FDO
Lyse”, “Empty FDT Lyse”, “Empty SLS-I Lyse” and “Empty Diluent” is same as “Empty WC”.
(2)Once instrument will not be used for 3 days-2 weeks, click “Empty pipeline” button on Figure 8-4-13, as
Figure 8-4-15 shows:

Figure 8-4-15

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After clicking “ ” button on above figure, as Figure 8-4-16 shows:

Figure 8-4-16

Take out reagent pipelines from reagent bottles and click “ ”key, the progress bar of “Emptying
Pipeline About 5 Minutes…”will display. If the operation of emptying pipeline has been completed the
“Operation Completed” will pop up. After that, the instrument should be placed in a cleaning surrounding.
(3)Once instrument will not be used for 2 weeks, please replace reagent with distilled water, click “Package
clean pipe” button on Figure 8-4-13, as Figure 8-4-17 shows:

Figure 8-4-17

Click button on above figure, the progress bar of “Package Clean Pipe About 33 minutes…”will
display and if the operation of package clean has been completed the “Operation Completed” will pop up.
After that , the instrument should be placed in a cleaning surrounding.
Then break-off distilled water and click “Package clean pipe” button on Figure 8-4-13, as Figure 8-4-18
shows:

Figure 8-4-18

After clicking “ ” button on above figure, as Figure 8-4-19 shows:

Figure 8-4-19

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Take out reagent pipelines from distilled water bottles and click “ ”key, the progress bar of
“Package Clean Pipe About 33 minutes…” will display, and if the operation of package clean has been
completed the “Operation Completed” will pop up. After that, instrument should be placed in a cleaning
surrounding.
8.4.3.2 Aperture
Aperture clog remove, zap and back-flush should be conducted in order to clear the debris in aperture.
Click “Zap”, the following box will pop up:

Figure 8-4-20

Click in above figure, to clean the aperture through high-voltage direct current. The progress bar
will pop up meanwhile.

Click “Back-flush”, 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 “Remove Clog”, the confirm box will pop up, click to zap and flush the aperture. The
progress bar will pop up meanwhile.
8.4.3.3 Soaking with Detergent
In order to ensure the accuracy of the test result, detergent soaking of WBC pool, RBC pool and DIFF pool
assembly should be conducted in the following conditions:
Scattergram of test result is abnormal.
Aperture clog failure.
(1)RBC Pool Soaking:
RBC pool soaking should be conducted every other week, the operation is as follow:
Click “RBC Pool” in Figure 8-4-13, as Figure 8-4-21 shows:

Figure 8-4-21

Click in above figure, as Figure 8-4-22 shows:

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Figure 8-4-22
The following box will pop up after soaking:

Figure 8-4-23
Click “Next” in Figure 8-4-23 to empty RBC, as the following figure shows:

Figure 8-4-24
Operation has been finished after emptying, as the following figure shows:

Figure 8-4-25

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 “WBC Pool” in Figure 8-4-13, as Figure 8-4-26 shows:

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Figure 8-4-26

Click in above figure, as 8-4-27 shows.

Figure 8-4-27
Click “Next” ,to empty WBC, as the following figure shows:

Figure 8-4-28
(3)DIFF Pool Soaking:
DIFF pool soaking should be conducted every other week, the operation is as follow:
Click “DIFF Pool” in Figure 8-4-13, as Figure 8-4-29 shows:

Figure 8-4-29

Click in above figure. As Figure 8-4-30 shows:

Figure 8-4-30

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The interface will pop up after soaking, as Figure 8-4-31shows:

Figure 8-4-31
Click “Next”, as the following figure shows:

Figure 8-4-32
“Operation Complete” will pop up after emptying.
8.4.4 Reagent Registration
Click “Reagent Register” in Figure 8-4-13, and then Figure 8-4-33 shows:

Figure 8-4-33
(1)Input the barcode information manually:
Manual barcode information input can be conducted if the external barcode reader is not connected.
Click barcode input box in Figure 8-4-33 to input the information according to the reagent package.

Click after input.

Left times: Scanning a barcode information for each, the remaining number will change accordingly (with the
reagent in proportion to the size of bottle).
(2)Scan barcode information
Connect the barcode reader (connect the data wire of barcode reader with computer), click the input box

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behind “Barcode” to turn into available status, scan the barcode outside the package box with barcode reader,
screen prompts “× × × register ok” and the barcode.
(3)Prompts for scanning failure
The following information will be prompted if scanning failed:

Figure 8-4-34
Input the information after checking if above condition occur. Contact the manufacturer’s his distributor for
continuous failure.
The following box will pop up if the barcode has been used:

Figure 8-4-35
Place another bottle of reagent if above condition happened.
(4)After reagent registration, replace corresponding reagent in the “Maintenance”→ “Replace/Prime”
interface.

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

8.5 Replacement of Wearing Components

8.5.1 Replace Syringe Pump
Syringe pump should be replaced after long time using.
The pump positions are as follows:

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Sample Pump

Figure 8-5-1

1 SLS-I Syringe Pump 2 FDO Syringe Pump 3 FDT Syringe Pump 4 Test Pump 5 Diluent Pump
Figure 8-5-2

8.5.2 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 probe, as Figure 8-5-3 shows:

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Figure 8-5-3
Pull puncture probe out vertically, as Figure 8-5-4 shows:

Swab

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

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

8.6 System Log

Click “Log” in the main interface, and select “Operation Log” from its pull-down menu, as Figure 8-6-1
shows:

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Figure 8-6-1
The operator can also select “Error Log” and “Failure Log” from its pull-down menu for checking.

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Chapter9 Failure Handling

This chapter describes various types of possible failure, the reason of the failure, and the solutions.

Test the result in case of failure may cause inaccurate result. If alarm is prompt in the process of testing,
failure solution should be adopted first.

9.1 Overview
See the following relative failure solution if failure occur during working process.
Alarm information will be prompted in failure information area if failure occurs. Click the failure, Figure 9-1-1
will pop up:

Figure 9-1-1
Failure information name and help will be displayed.
Name of failure information will be displayed according to the order of the failure.
The failure solution can be checked in detail information.

Press to clear the failure information. Click .

9-1

9.2 Failure Information and Solution
Alarm Information
Dilute Motor Error
Dilute Motor Sensor Error
Swab motor error
Swab clean motor error
SLS-I Lyse Empty
Data Collection Board Verification
Error
Data collection board is disconnected
Laser temperature is too high.
Laser temperature is too low.
Laser temperature sensor disconnected.
Room temperature is too high.
Room temperature is too low.
Room temperature sensor disconnected.
WBC pool temperature is too high.
WBC pool temperature is too low.
User Manual
Solution
1. Click Clear to clear this failure.
2. Check whether dilution motor failure occurs.
1. Click Clear to clear this failure.
2. Check whether dilution motor sensor failure occurs.
1. Click Clear button to automatic clear failure.
1. Click Clear button to automatic clear failure.
1. Please check whether SLS-I Lyse is sufficient.
2. Please replace new reagent if there is no reagent and clear the failure.
3. Check the floater switch if the reagent is sufficient.
1. Click Clear to clear this failure.
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 connected if this
failure remains.
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.
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.
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 remains.
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]℃.
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]℃
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 remains.
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.
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.
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.
9-2

Alarm Information
WBC pool temperature sensor
disconnecting
Test Motor Error
Test Motor Sensor Error
Sheath motor error
Sheath motor limit error
Waste Barrel Full
Sampling Motor Error
Sampling Motor Sensor Error
Waste Bottle Full
x-Axis Motor Error
x-Axis Motor First Sensor Error
x-Axis Motor Second Sensor Error
x-Axis Motor Third Sensor Error
x-Axis Motor Fourth Sensor Error
x-Axis Motor Fifth Sensor Error
x-Axis Motor Sensor Error
Y-Axis Motor Error
Front door is opened
STAT Loader Unavailable
Diluent Barrel Empty
HGB background voltage exceeds range
5V Voltage Exceeds Range
58V Voltage Exceeds Range
Laser Current Exceeds Range
FDO Lyse Empty
FDT Lyse Empty
User Manual
Solution
1. Click Clear to clear this failure.
2. Please check the temperature sensor connection if this failure remains.
3. Please check whether the temperature sensor has been damaged. Replace it if it
is damaged.
1. Click Clear to clear this failure.
2. Please check whether test motor failure occurs if this failure remains.
1. Click Clear to clear this failure.
2. Please check whether test motor sensor failure occur if this failure remains.
1. Click Clear button to automatic clear failure.
1. Click Clear button to automatic clear failure.
1. Empty waste barrel or replace it with new waste barrel.
2. Please check the connection between sensor and mainframe if this failure
remains.
3. Check the floater sensor.
1. Click Clear to clear this failure.
2. Please check the sampling motor if this failure remains.
1. Click Clear to clear this failure.
2. Please check the sampling motor sensor if this failure remains.
1. Empty waste barrel or replace it with new waste barrel.
1. Click Clear to clear this failure.
2. Please check X axis motor if this failure remains.
1. Click Clear to clear this failure.
2. Please check X axis motor sensor 1 if this failure remains.
1. Click Clear to clear this failure.
2. Please check X axis motor sensor 2 if this failure remains.
1. Click Clear to clear this failure.
2. Please check X axis motor sensor 3 if this failure remains.
1. Click Clear to clear this failure.
2. Please check X axis motor sensor 4 if this failure remains.
1. Click Clear button to automatic clear failure.
2. Please check X axis motor sensor 5 if this failure remains.
1. Click Clear button to automatic clear failure.
2. If this failure still exists, check if failure occurs on the sensor of X-axis motor.
1. Click Clear to clear this failure.
2. Please check Y axis motor if his failure remains.
1. Click Clear to clear this failure automatically.
1. Apply lube to motion bearing.
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 Clear to prime
diluent.
3. Check the floater switch if the diluent is sufficient.
1. Please check whether the diluent has been contaminated.
2. Click Clear if diluent has not been contaminated to clear this failure.
1. Click Clear to clear this failure.
2. Please replace the circuit board if this failure unrestored.
1. Click Clear to clear this failure.
2. Please replace the circuit board if this failure remains.
1. Click Clear to clear this failure.
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 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 failure.
3.Check the floater switch if the reagent is sufficient.
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Alarm Information
Lyse Motor Error
Lyse Motor Sensor Error
Tube rack feed to spacing sensor
error(posteroanterior)
Tube rack feed to home position
error(posteroanterior)
There is object on feeding position(left
right)
Tube rack feeding position error(left
right)
Tube rack feed to home position
error(left right)
Feeding motor have not moved(left
right)
Tube rack(left right) feed to left side
microswitch error
Tube rack(left right) feed to right side
microswitch error
Reset sensor of shake up motor error
Shake up sensor of shake up motor error
Diluent Bottle Empty
Pressure Error
Left side tube racks are full.
Tube rack has been moved
Have no tube rack
Tube racks have not been moved out.
Move tube rack from home position
error
Y Axis Motor Sensor Error
S1 optocoupler error.
Valve check error
Data collect board communication error.
Emptying waste liquid fault fails.
User Manual
Solution
1. Click Clear to clear this failure.
2. Please check whether lyse agent motor failure occurs if this failure remains.
1. Click Clear to clear this failure.
2. Please check whether lyse agent motor sensor failure occurs if this failure
remains.
1. Check if there is barrier on mobile pipeline. If any, remove it.
2. Please check K2 switch.
1. Check if there is barrier on mobile pipeline. If any, remove it.
2. Applies lubed on mobile bearing.
1. Check if there is barrier on mobile pipeline. If any, remove foreign body.
2. Please check S2 optocoupler.
1. Check if there is barrier on mobile pipeline. If any, remove foreign body.
2. Applies lubed on mobile bearing.
1. Check if there is barrier on mobile pipeline. If any, remove foreign body.
2. Please check K4 switch.
1. Check if there is barrier on mobile pipeline. If any, remove foreign body.
2. Applies lubed on mobile bearing.
Please check K6 switch.
Please check K5 switch.
1. Applies lubed on mobile bearing.
2. Please check K7 switch
1. Applies lubed on mobile bearing.
2. Please check K8 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 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.
3. Please check the air pipe connection.
4. Please adjust the pressure regulating valve.
Check if tube racks in left side of sampler are full
Check K5、K6 switch
Check if tube racks in right side of sampler are full
1. Check if there is barrier on mobile pipeline. If any, remove foreign body.
2. Please check S2 optocoupler.
1. Apply lubed on mobile bearing.
2. Please check K9 switch
1. Click Clear to clear this failure.
2. Check whether Y axis motor sensor failure occurs.
1. Please check S1 optocoupler.
2. Please check S1 optocoupler catch.
1. Check control board chip TPIC6A595.
2. Reset MU.
1. Check data collect board joint.
1. Please check waste liquid pump.
2. Please check waste liquid valve.
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Chapter10 Instrument Transportation and Storage

10.1 Transportation
The transportation of the instrument should be in accordance with the contract stipulation. It should avoid
violent collision and should be protected from corrosive materials.

10.2 Storage
The packaged instrument should be kept in a well-ventilated room without corrosive gas, the temperature
should be -10℃~40℃, the relative humidity should be no more than 75%.

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AppendixA Network Communication Interface Protocol V1.1

A.1 Network Communication Interface Protocol V1.1
This protocol is used for information transmission between BF Series Automatic Hematology Analyzer
(Model: BF-6800) 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)
Field: segment made by several date fields. Different date field are separated by list separator.
Syntax Format
<SB>dddd<EB><CR>
<SB>: message start symbol (1byte). ASCII character<VT>, namely, 0x0B.
dddd: data(made up by different length bytes). This is the HL7data content. Data could contain any byte value
and ASCII code’s carriage return symbol greater than hex value 0x1F ,<CR>.
<EB>: message end character(1 byte). ASCII character <FS>, namely, `0x1C.
<CR>: carriage return (1 byte). ASCII character<CR>, namely, 0x0D.
Example:
<SB> MSH|^~\&|LIS|1234567890|||20100427194802||ORU^R01|1|P^S|2.4| <CR>
<EB><CR>
There into:
5 character after MSH are list separators used to differentiate each field, discreteness and sub-discreteness.
Although those character could be any non-text character, but HL7 standard recommend following characters:
Delimiter Value
Field Separator |
Discreteness Separator ^
Sub-Discreteness Separator &
Repeat Separator ~
ESC \

A.3 Message Segment Used in this Protocol

MSH-message head
PID-patient information
PV1-case history
OBR-test report information
OBX-test report test information
EQU –instrument detail
NDS - instrument affiche detail
A.4 HL7 Attribute Table
Message segment in the protocol could be divided into required, optional, and repeatable.
MSH Definition Table.

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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|UNICODE<cr>
Serial HL7 Advised
Field Name Length Explanation Example
NO. Length
Include the first field separator after
1 Field Separator 1 1 message segment, used for regulating |
other message field separator value
Include discreteness separator, repeat
2 Coded Character 4 4 separator, ESC ,sub-discreteness ^~\&
separator
Send terminal apply program
3 Send Program 7 180 XXX
value: XXX
Sending terminal instrument, value:
4 Instrument Code 10 180 1234567890
instrument code

Message created time (form As

7 Send Time 14 26 YYYY[MM[DD[HH[MM[SS]]]]]), Take 20110310144704
system time value

Message type, form as “information type”

9 Message Type 7 7 event type, value: ORU^R01(Sample) ORU^R01
OUL^R21 (LJ/X, XB QC)

Message control ID is used for only mark

10 Message Control ID 20 20 361
one message, value :PID
This field is used for decide on whether
to transact HL7 operation program’s(7th
layer) transact rule definition
11 Transact ID NO. 3 3 P^S
information.
Value: P^ message type(Type Value:
S-sample, LJ-LJ /X barQC, XB-XB QC)
Agreements adopt HL7 version No.
12 HL7 Version NO. 3 60 2.4
Value: 2.4

17 Nation Code 3 3 Nation code mark, refer to HL 7 2.4 CHN

ISO/IEC 10646-1-1993 International

18 Character Set 10 10 UTF-8
character standard value: UTF-8

PID:
PID–patient information: this information segment is optional, used for patient sample transmission; include
patient case history number, name, age, gender etc.
Message Example
PID||1234567890||| Wang San Qiang||| M<cr>
Serial HL7 Advised
Field Name Length Explanation Example
NO. Length
Patient ID, here used for patient case
2 Case History no. 20 20 1234567890
history NO.

5 Name 50 250 Patient name Wang San Qiang

8 Gender 10 1 Gender, showed as character string M

PV1 Definition Table

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PV1 –patient in hospital information : This message segment is optional, use for patient sample transmission,
include patient department, bed NO., deliver doctor, examiner and so on.

Message example:

PV1||| clinic^^235689|||| doctor Wang| Zhang San| Li Si<cr>

Serial HL7 Advised
Field Name Length Explanation Example
NO. Length
Pointed patient
3 80 80 form as :department^^bed no. ^^clinic 235689
position

7 Deliver doctor 50 250 deliver doctor, character string doctor Wang

8 Examiner 50 250 examiner, character string Zhang San

9 Auditor 50 250 auditor, character string Li Si

OBR Definition Table

OBR –testing report list information: This information segment is optional, mainly include test report
information, include sample serial number, and scan No., tube rack No., deliver time and so on.
Message example :
OBR||23|31C3F010230DFB03|0001^Count
Results||20071207080000|20071207160000|||||| |20071207083000||||2311|322<cr>
Serial HL7 Advised
Field Name Length Explanation Example
NO. Length
Sample Serial Sample number in testing
2 16 22 23
Number Document No. in LJ/X QC
Barcode ID in sample testing 31C3F010230DF
3 Scan No. 32 22
Lot No. in LJ/X QC B03
Service ID symbol, used for sign on
Data Service different count result type. 0001^Count
4 200 200
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.

18 Tube Rack NO. 2 60

19 Tube NO. 2 60

OBX Definition Table

OBX –Test result: this message segment is repeatable item, mainly include all test result parameter
information and sample test mode, analysis mode and reference group, etc.
Message example
OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00|L|||F<cr>
Serial HL7 Advised
Field Name Length Explanation Example
NO. Length
Used for mark different OBX message
1 Serial NO.ID 10 10 1
segment

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Serial HL7 Advised

Field Name Length Explanation Example
NO. Length
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
3 ID Symbol 250 250 reference as appendix: identify coding
definition. NOTE:ID used for only make one
testing parameter, but name mainly for
descript, not for mark.
Test result data, could be number, character
test result,
string, enumerate value, binary system etc,
chart data,
data specific value reference the enumerate
5 notes, quality 65536 65536
value table.( Binary data such as histogram
control
and scatter plot, using Base64 encoding to do
level……
conversion)
Unit, note: "^" in unit conflicts with
6 Unit 10 250 10*9/L
discreteness separator, so use "*" to instead
Test Result The scope of the test results, forms: "the
7 Reference 20 60 reference range lower limit - upper limit of 12.463-33.569
Value reference range"
Test Result Test result condition. Value is “F” -
11 20 20 F
Condition (Final Result) . Shows final test results

This protocol use the custom coding approach.

OBR-4 Code Definition
Code Name Explanation OBR-4 Field

1001 Count Results sample count result 1001^ Count Results

1002 LJ QC LJ QC count result 1002^ LJ QC

1004 XB QC XB QC count result 1004^ XB QC

OBX-3 Identify Coding Definition

Code Name Explanation Value Type OBR-3 Field
2001 MODE test mode IS 2001^MODE
2002 MODE_EX analysis mode IS 2002^MODE_EX
2003 Ref Reference IS 2003^Ref
2004 Age Age NM 2004^Age
2005 Note Note ST 2005^Note
2006 Level L-J/X QC level IS 2006^Level
2007 V_WBC total white blood cell NM 2007^V_WBC
2008 V_BAS_c The number of basophils NM 2008^V_BAS_c
2009 V_NEU_c The number of neutrophils NM 2009^V_NEU_c
2010 V_EOS_c The number of acidic granulocyte NM 2010^V_EOS_c
2011 V_LYM_c The number of lymphocytes NM 2011^V_LYM_c
2012 V_MON_c The number of mononuclear cells NM 2012^V_MON_c
2013 V_BAS_p The percentage of basophils NM 2013^V_BAS_p
2014 V_NEU_p The percentage of neutrophils NM 2014^V_NEU_p

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Code Name Explanation Value Type OBR-3 Field

2015 V_EOS_p The percentage of eosinophils NM 2015^V_EOS_p
2016 V_LYM_p Lymphocyte percentage NM 2016^V_LYM_p
2017 V_MON_p percentage of Monocytes NM 2017^V_MON_p
2018 V_RBC The number of red blood cells NM 2018^V_RBC
2019 V_HGB Hemoglobin NM 2019^V_HGB
2020 V_MCV MCV NM 2020^V_MCV
2021 V_MCH Mean corpuscular hemoglobin NM 2021^V_MCH
Mean corpuscular hemoglobin
2022 V_MCHC NM 2022^V_MCHC
concentration
Coefficient of variation of red
2023 V_RDW_CV NM 2023^V_RDW_CV
blood cell distribution width
Standard deviation of red blood
2024 V_RDW_SD NM 2024^V_RDW_SD
cell distribution width
2025 V_HCT Hematocrit NM 2025^V_HCT
2026 V_PLT Platelet count NM 2026^V_PLT
2027 V_MPV Mean platelet volume NM 2027^V_MPV
2028 V_PDW Platelet distribution width NM 2028^V_PDW
2029 V_PCT Platelet hematocrit NM 2029^V_PCT
2030 V_P_LCR Platelet - macrophage ratio NM 2030^V_P_LCR
RBC
2101 Histogram.BI RBC scattergram BMP data ED 2101^RBC Scattergram.BMP
N
PLT
2102 Histogram.BI PLT scattergram BMP data ED 2102^PLT Scattergram.BMP
N
WBC
2103 Histogram.BI WBC scattergram BMP data ED 2103^WBC Scattergram.BMP
N
DIFF
2034 Scattergram.B DIFF scattergram BMP data ED 2034^DIFF Scattergram.BMP
MP
WBCD
2104 Scattergram.B WBCD scattergram BMP data ED 2104^WBCD Scattergram.BMP
MP
How many quality control in XB
2079 XB_Num NM 2079^ XB_Num
to generate a quality control

Enumeration Type
Data Item Value
0-CBC
test mode
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)

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Data Item Value

0- normal
1- M
2- F
3- Child
4- baby
Reference
5- custom 1
6- custom 2
7- custom 3
8- custom 4
9- custom 5
0- high
L-J/X QC level 1- medium
2- low

Whole Information Segment Example

(1)Patient Sample
<SB> MSH|^~\&|XXX||||20110310150421||ORU^R01|8|P^S|2.4|||||CHN|UTF-8<cr>
PID||1234567890|||Wang Sanqiang|||Male<cr>
PV1|||clinic^^235689||||Doctor Wang|ZhangSan|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>

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 User Manual

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^WBCScattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
<EB><CR>
(2)L-J/X QC
<SB>MSH|^~\&|XXX||||20110311091016||OUL^R21||P^LJ|2.4|||||CHN|TUF-8<cr>
OBR||2|123 |1002^ LJ QC||20100819 |20110217131356|||||| |||||0|0<cr>
OBX|1|IS|2006^Level||0||||||F<cr>
OBX|2|NM|2007^V_WBC||4.63||||||F<cr>
OBX|3|NM|2008^V_BAS_c||4.63||||||F<cr>
OBX|4|NM|2009^V_NEU_c||4.63||||||F<cr>
OBX|5|NM|2010^V_EOS_c||4.63||||||F<cr>
OBX|6|NM|2011^V_LYM_c||4.63||||||F<cr>
OBX|7|NM|2012^V_MON_c||4.63||||||F<cr>
OBX|8|NM|2013^V_BAS_p||4.63||||||F<cr>
OBX|9|NM|2014^V_NEU_p||4.63||||||F<cr>
OBX|10|NM|2015^V_EOS_p||4.63||||||F<cr>
OBX|11|NM|2016^V_LYM_p||4.63||||||F<cr>
OBX|12|NM|2017^V_MON_p||4.63||||||F<cr>
OBX|13|NM|2018^V_RBC||4.63||||||F<cr>
OBX|14|NM|2019^V_HGB||4.63||||||F<cr>
OBX|15|NM|2020^V_MCV||4.63||||||F<cr>
OBX|16|NM|2021^V_MCH||4.63||||||F<cr>
OBX|17|NM|2022^V_MCHC||4.63||||||F<cr>
OBX|18|NM|2023^V_RDW_CV||4.63||||||F<cr>
OBX|19|NM|2024^V_RDW_SD||4.63||||||F<cr>
OBX|20|NM|2025^V_HCT||4.63||||||F<cr>
OBX|21|NM|2026^V_PLT||4.63||||||F<cr>
OBX|22|NM|2027^V_MPV||4.63||||||F<cr>
OBX|23|NM|2028^V_PDW||4.63||||||F<cr>
OBX|24|NM|2029^V_PCT||4.63||||||F<cr>
OBX|25|NM|2030^V_P_LCR||4.63||||||F<cr>
OBX|26|ED|2031^RBC Histogram.BIN||……BIN binary system data change to BASE64 code……||||||F<cr>
OBX|27|ED|2032^PLT Histogram. BIN||……BIN binary system data change to BASE64 code……||||||F<cr>
OBX|29|ED|2035^BASO Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
<EB><CR>

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(3)X-B QC
<SB>MSH|^~\&|XXX||||20110311091040||OUL^R21||P^XB|2.4|||||CHN| UTF-8<cr>
OBR||||1004^ XB QC|||20071207160000||||||||||||<cr>
OBX|1|NM|2079^XB_Num||20||||||F<cr>
OBX|2|NM|2073^m_MCV_R||12.204||||||F<cr>
OBX|3|NM|2074^m_MCH_R||0.258||||||F<cr>
OBX|4|NM|2075^m_MCHC_R||12.445||||||F<cr>
OBX|5|NM|2076^m_MCV_L||45.859||||||F<cr>
OBX|6|NM|2077^m_MCH_L||1.258||||||F<cr>
OBX|7|NM|2078^m_MCHC_L||2.36||||||F<cr>
OBX|8|NM|2020^V_MCV||4.63||||||F<cr>
OBX|9|NM|2021^V_MCH||4.63||||||F<cr>
OBX|10|NM|2022^V_MCHC||4.63||||||F<cr>
<EB><CR>

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 User Manual

AppendixB Report Designer User Guide

The report can be modified or created through report designer setting to design the ideal report format. We
offer the following two kinds of report template:
(1)With no graph, paper can be saved
(2)With graph, the default report format.
For initial use, please save the template before modification. For the design of the template is debugged strictly,
inappropriate changes may affect the printing.
The following describes the specific function and use of the report designer.
B.1 Report Designer Object
Report designer is in the toolbar(left), a total of three objects:
Icon Name Description
TextBox Rectangular box which contain multiple lines of text. Allow contain variable text.
PictureBox Display picture format of BMP, ICO, WMF, EMF and JPG
Line Draw vertical or horizontal lines in report.

B.1.1 “TextBox”
Rectangular box which contain multiple lines of text. Type, color and width of frame, font attribute, text
alignment and font direction (vertical or horizontal) can be set. Use “Text” and “Frame” tools to set the
attribute of the object, as Figure B.1 shows:

Figure B.1
Text box object includes: text, variables, data fields or any combination of these. Font formatting will be
applied to all text included in text object.
TextBox Modification:
Click on the left of Report Edit Designer, click the left mouse after rectangular icon appears, as shown in
Figure B.2:

Figure B.2

Clipboard operation;

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Word wrap;

Cancel button;

OK button;
Note: data included in the database includes patient information, sample test information, the corresponding
set of specific field will be detailed in the following chapter.
B.1.2 “Picture Frame”
Picture can be inserted in the report. The format of the picture is BMP, WMF, ICO.
Picture frame modification:
Click on the left of Report Edit Designer, click the left mouse after rectangular icon appears, as shown in
Figure B.3:

Figure B.3
Click “Select.” in Figure B.3, and click “OK”, the picture can be inserted into the report.
B.1.3 “Line”
The horizontal or vertical line can be inserted in the report. In separate statement of the report, straight-line
makes it easy to be read. The line thickness and color can be adjusted by using the drawing toolbar.
Click , drag the mouse in the current page, the cursor will turn into a pencil to draw a straight line. Click
the mouse to begin the line, release it when the line is finished. The line can be modified.
Line modification: select the corresponding button in “frame toolbar” to modify the line.
(1)“Standard” toolbar

(2)“Format” toolbar

(3)“Frame” toolbar

(4)“Alignment” toolbar

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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 from the pull-down menu of paper size.
If the current printing support self-defined paper format, select “Self-defining”, and then input the width and
length of the paper format.

Not all printer drive or printer support self-defining paper format (e.g. printer drive “HP LaserJet
6L”does not support 76*127mm size; printer drive “HP LaserJet 4L”does not support all self-defining
size)
B.2.2 Paper Source
Click “Paper Source” in Figure B.4, as Figure B.5 shows:

Figure B.5
Select the commonly used paper source.
B.2.3 Margins
Click “Margin” in Figure B.4, as Figure B.6 shows:

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 User Manual

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 \ Sample: is patient sample report template ; \ Print \ QC: is QC report template.
Concrete action : Open → select report →edit → Select All →New Report→ Page Setup→Paste. In this new
report, the position, font and the letter of text can be modified.
B.3.1 Title
Set the sample test report and QC report in “System Setting”. For example: × × × hospital, the title is × × ×
hospital test report. The “Test Report” can be set hereby. It can be modified into “Blood test report”,“LJ
report”, etc. The title can be modified into static text.
B.3.2 Paper
Users also can modify the size of print paper. If the user use inkjet or laser printer and A4 paper, set paper A4.
If the user use stylus printer (such as: epson 300K, 1600K, etc.), and use 80 column printing paper, set the

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 User Manual

paper to be self-defining. If a 80 column paper need to print three reports, set the paper to be 9.34(length). If a
80 paper need to print two reports, set the paper to be 14, paper width is 22. The default margin is 0.
B.3.3 Select the object need to be modified:
Click the object need to be modified with mouse (points around the selected object will appear), press Shift,
more than one objects can be selected. Press Ctrl, and move the mouse meanwhile, then the mouse moved area
will be selected.
Modify the letter of the static text: select the text need to be modified, and double click the textbox, input the
modified letter in the corresponding box, and press “Enter”.
Modify the data field: If it is used to display certain data, only one textbox need to be added to appropriate
position, double-click the text box, input the data value, refer to the existing template for the value.
Move object: select the object (more than one can be selected), then press the four buttons around "Move" to
move the object, arrow keys on the keyboard can also be used.
Change size: select the object, press the up and down buttons of “high” or “width” to increase or decrease the
height or width.
Change the font: Select the object, and then select the font size or bold, italic and so on.
Undo: error happened during modification, undo operation for one or more times, the report will return back to
the style before modification.
Save: press the “Save” button after all operation is completed. Note: If it is patient sample report, please store
in the software installation directory \ Print \ Sample folder; save quality control report into \ Print \ QC folder
of software installation directory
Use: open the system setting in data management software, select the report in print setting.

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AppendixC Product Warranty

Dear customer:
Thank you for purchasing BF Series Automatic Hematology Analyzer (Model: BF-6800) of our company. We
can offer you the following service:
(1)Technique consultation is provided at any time.
(2)One year warranty from the day purchased.
(3)Paid service is provided in following condition:
a)Product out of warranty period.
b)Damage caused by accident or wrong operation.
c)Operation is not according to the user manual requirement.
d)Repair the instrument without our permission.
(4)With the development of technology, we will supply the service of update of BF Series Automatic
Hematology Analyzer (Model: BF-6800).

If you need any technological service, please reach us according to the following address and telephone:
Register/Manufacturer: DIRUI INDUSTRIAL CO.,LTD.
Register/ Manufacturer Address:
95 Yunhe Street, New&High Tech. Development Zone, Changchun, Jilin 130012, the People’s Republic of
China
Headquarter Address:
3333 Yiju Street, New&High Tech. Development Zone Changchun,Jilin 130103, the People’s Republic of
China
Factory Address:
95 Yunhe Street, New&High Tech. Development Zone Changchun,Jilin 130012, the People’s Republic of
China
Tel.: 400 811 6695 400 811 6605
Website: http://www.dirui.com.cn
E-mail:dirui@dirui.com.cn
For complaint: +86(431)81935326 85177245
Fax: +86(431)85173354

After-Sale Service From: DIRUI INDUSTRIAL CO.,LTD.

International customer service hotline:+86 400 808 7597
International customer service e-mail:service@dirui.com.cn

Domestic customer service hotline:400 811 6695 400 811 6605

Domestic fax: +86(431)85100405
Domestic customer service e-mail:service.ch@dirui.com.cn

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AppendixD Product Description

D.1 Product assortment
According to medical equipment product assortment catalogue:
Belongs to blood analyze system in clinic counting instrument (6840), type II in management type.
D.2 Accessory reagent
(1)BF-Diluent
(2)BF-FDT Lyse
(3)BF-6500 Lyse (SLS-I)
(4)BF-FDO Lyse
(5)BF Detergent
D.3 Reagent consumption
Operation must be done by instrument Consumption
Sleep (Instrument has not been used for 2 hours) Diluent 40mL
Wake up (Use Instrument again; Sleep time within 3 hours) Diluent 30mL
Wake up (Use Instrument again; Sleep time: 3-10 hours) Diluent 70mL
Wake up (Use Instrument again; Sleep time exceeds 10 hours) Diluent 110mL
Diluent 240mL
Detergent 12mL
Manual rinse FDO Lyse 3.8mL
FDT Lyse 0.5mL
SLS-I Lyse 1mL
Diluent 173mL
Detergent 7mL
Automatic rinse(Set times: 10-200) FDO Lyse 3.8mL
FDT Lyse 0.4mL
SLS-ⅠLyse 0.8mL
Diluent 160mL
Detergent 7mL
Automatic rinse before sleep (Set times: 10-600) FDO Lyse 4mL
FDT Lyse 0.5mL
SLS-I Lyse 1mL
Diluent 130mL
FDO Lyse 2mL
Power on
FDT Lyse 0.22mL
SLS-ⅠLyse 0.5mL
Diluent 155mL
Power off
Detergent 14mL

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 User Manual

Operation must be done by instrument Consumption

Rinse WBC Pool Diluent 16mL
Rinse RBC Pool Diluent 12mL
Rinse DIFF Pool Diluent 13mL
Diluent 46mL
Rinse Swab
Detergent 2.2mL
Rinse Sheath Flow Pool Diluent 13mL
Clear sample loader bubbles Diluent 13mL
Remove Clog Diluent 28mL
Backflush Diluent 25mL
Diluent 104mL
Detergent 3.7mL
Soaking WBC FDO Lyse 2mL
FDT Lyse 0.22mL
SLS-I Lyse 0.5mL
Diluent 104mL
Detergent 3.8mL
Soaking RBC FDO Lyse 1.9mL
FDT Lyse 0.22mL
SLS-I Lyse 0.5mL
Diluent 142mL
Detergent 6.2mL
Soaking DIFF FDO Lyse 4mL
FDT Lyse 0.5mL
SLS-I Lyse 1mL

Operation must be done by instrument Consumption for prime and rinse

Prime FDO Lyse (After drain) FDO Lyse 10mL
Prime FDT Lyse (After drain) FDT Lyse 10mL
Prime SLS Lyse (After drain) SLS-I Lyse 10mL
Diluent 270mL
FDO Lyse 2mL
Prime Diluent (After drain)
FDT Lyse 0.22mL
SLS-I Lyse 0.5mL
Diluent 48mL
FDO Lyse 15mL
Replace FDO Lyse
FDT Lyse 0.22mL
SLS-I Lyse 0.5mL

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 User Manual

Operation must be done by instrument Consumption for prime and rinse

Diluent 48mL
FDT Lyse 13.22mL
Replace FDT Lyse
FDO Lyse 2mL
SLS-I Lyse 0.5mL
Diluent 52mL
SLS-I Lyse 13.5mL
Replace SLS-I Lyse
FDO Lyse 2mL
FDT Lyse 0.22mL
Diluent 350mL
FDO Lyse 2mL
Replace Diluent
FDT Lyse 0.22mL
SLS-I Lyse 0.5mL
Diluent 15.5mL
Replace Detergent
Detergent 5mL

Reagent consumption per test (no automatic rinse)

Diluent (whole blood) 44mL
SLS-I Lyse 0.5mL
FDO Lyse 2mL
FDT Lyse 0.22mL

D.4 Parameter Description

The parameter is obtained from histogram or scattergram.
Name Ab Unit
Lymphocyte Percentage LYM% %
Monocyte Percentage MON% %
Neutrophil Percentage NEU% %
Eosinophil Percentage EOS% %
Basophil Percentage BAS% %
Mean RBC Volume MCV fL
Variation coefficient of RBC width
RDW-CV %
distribution
Standard deviation of RBC width distribution RDW-SD fL
Mean Platelet Volume MPV fL
Platelet Width Distribution PDW %

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 User Manual

The parameter is obtained from calculation.

Name Ab Unit
Lymphocyte Number LYM# 10 ／L
9

Monocyte Number MON# 109／L

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

Mean RBC Hemoglobin Concentration MCHC g／L

Platelet Hematocrit PCT %

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 User Manual

AppendixE Performance Index

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

Parameters Linearity Range Linearity Error

(1.0-10.0)×109/L No more than ±0.5×109/L

WBC
(10.1-99.9)×109/L No more than±5.0%

(0.30-1.00)×1012/L No more than±0.05×1012/L

RBC
(1.01-7.00)×1012/L No more than±5.0%

(20-70) g/L No more than±2g/L

HGB
(71-240) g/L No more than±3.0%

(20-100)×109/L No more than±10×109/L

PLT
(101-999)×109/L No more than±10.0%

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

WBC (4.0-10.0)×109/L ≤4.0%

RBC (3.50-5.50)×1012/L ≤2.0%

HGB (110-160) g/L ≤2.0%

PLT (100-300)×109/L ≤8.0%

HCT/ (35-50)% ≤3.0%

MCV (80-100)fL ≤3.0%

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 User Manual

E.6 Carry-over Contamination Rate

(1)RBC≤2.0%.
(2)WBC≤3.5%.
(3)HGB≤2.0%.
(4)PLT≤5.0%.

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 User Manual

AppendixF Accessories List

The accessories list includes accessories, fittings, and consumables.

Replacement
Name Position Replacement Cycle Remarks
Guide

3000h (continuous
Sampling Pump Sampling Syringe Unit 8.5.1
working)

Sheath Liquid Syringe 3000h (continuous

Testing Pump 8.5.1
Unit working)

BF-SLS-I Four linked Syringes 3000h (continuous

8.5.1
Syringe Pump Unit working)

BF-FDO Syringe Four linked Syringes 3000h (continuous

8.5.1
Pump Unit working)

BF-FDT Syringe Four linked Syringes 3000h (continuous

8.5.1
Pump Unit working)

BF-Diluent Four linked Syringes 3000h (continuous

8.5.1
Syringe Pump Unit working)

Puncture Probe Sampling Unit 100,000 samples 8.5.2

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
HGB Light 10,000 h Contact the by the representative
Counting Unit
Source (continuous working) service staff. from the manufacturer
or distributor only.
Reagent Bottle
Back of the analyzer timely 2.3.1
Assembly

Detergent
Back of the analyzer timely 2.3.1
Assembly

Diluent Tank Cap

Back of the analyzer timely 2.3.1
Assembly

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F-2