BCC-3900 Dirui Manual de Usuario

The User Manual is applicable to Automatic Hematology Analyzer (model: BCC-3900/BCC-3960) and all
figures concerned are described based on the Automatic Hematology Analyzer (model: BCC-3900,
hereinafter referred to as the Analyzer).
Description
Dear users, thanks for buying the Automatic Hematology Analyzer (model: BCC-3900/BCC-3960).
Please read the manual carefully before operation as incorrect operation may affect the test results of the Analyzer
or cause personal injury.
After reading, please keep the manual properly for reference at any time.
Manufacturer: DIRUI INDUSTRIAL CO., LTD.
Manufacturer Address:
95 Yunhe Street, New & High Tech. Development Zone, Changchun, Jilin 130012, the People’s Republic of China
Production Address:
3333 Yiju Road, New & High Tech. Development Zone Changchun, Jilin 130012, the People’s Republic of China
Place of Production: Changchun, China
Tel.: 400 811 6695 400 811 6605
Website: http://www.dirui.com.cn
E-mail：dirui@dirui.com.cn
Complaints Hotline: 0431-81935326 85177245
Fax: 0431-85173354
Date of Production: See the label.
Service Life: 7 years
Date of Compilation/ Revision: 07-2018.

CAUTION
● The Analyzer shall be used by professional medical examination personnel or trained doctors, nurses or testers.
● As the Analyzer has biological and chemical risks, the operator shall be trained and use personal protective
appliance to reduce the risk.
● Only trained operators are allowed to conduct dangerous operations, such as moving parts.
● The hospital or inspection institution shall prepare a service plan and carry out servicing and maintenance in
strict accordance with the service plan, or the Analyzer may have faults.
● The Analyzer shall be controlled with a special software designated by the company. Installation of other
software or hardware on the computer may affect the normal operation of the Analyzer. Please do not operate
other software during the operation of the Analyzer.
● Please refer to the instructions of reagent for the use and storage of the reagent and ensure the reagent is used
within the life of the reagent shown in the instructions.
● Do not use reagent beyond its life. After its seal is damaged, prevent dust, dirty matter or bacteria entering it.
● Do not use any organic solvents such as turpentine and benzene to rinse the outer part of the Analyzer as it may
cause the color or shape changes of the Analyzer. Use soft or wet cloth to clean the Analyzer and use diluted
cleanser or ethanol to remove severe stains.
● Under an environment with low transportation or storage temperature or relative humidity greater than 85%, the
Analyzer shall be turned on for testing only after it is stored in a normal working environment for 24 hours.
● The Analyzer shall be provided with an independent power source. If it shares one power socket with other
electrical equipment, the electromagnetic interference may affect the test results of the Analyzer.
● Do not pull or insert the plug with wet hands as it may cause electric shock.
● Damaged power cable and connection cable shall not be used. The power cables and wires shall not be trodden,
twisted or pulled as it may cause a fire.
● The Analyzer can only be used under a good grounded condition.
● The input voltage shall meet the requirements of the Analyzer and the fuse of specified specification shall be
used.
● Ensure the switch of the Analyzer is at the [O] position before connecting the power cable.
● The Analyzer shall not be used in a flammable and explosive environment.
● Do not touch the moving components when the Analyzer is operating to prevent accidents.
● When the power for the Analyzer is connected, servicing personnel not authorized shall not open the left and
right doors and upper cover.
● Please use the Analyzer under conditions regulated in the manual. If not, the Analyzer may not operate normally,
the test results may not be reliable, the components of the Analyzer may be damaged and personal injuries may be
caused.
● The protection measures provided for the Analyzer may become invalid if the Analyzer is not used according to
the manual.
WARNING
● The operator is obligated to follow national and local regulations on discharge and treatment of expired reagent,
waste liquid, waste sample and consumables.
● The waste liquid and the consumables shall be correctly treated. As the blood in the waste liquid may be
polluted by pathogen, please treat the waste liquid and the consumables of the Analyzer according to regulations
about medical waste, infectious waste and industrial waste.
● Do not touch the aspiration probe as the blood sample, quality control object and calibration object on the
aspiration probe have potential biological infectivity. During the sample aspirating process of the aspiration probe,
prevent touching the test tube wall and probe tip as it may cause bleeding. Besides, a certain distance shall be kept
from the aspiration probe tip to the bottom of container, or the accuracy of the aspirated liquid volume may be
affected.
● Do not touch the blood sample of patients directly.
● Disposable articles shall not be used repeatedly.

DECLARATION
Dirui Company has the final interpretation right of the manual.
Dirui Company declares that it will be responsible for the safety, reliability and performances of the Analyzer only
if all following requirements are met.
(1)The installation, commissioning and servicing of the Analyzer are undertaken by professional personnel of
Dirui Company.
(2)Relevant electrical equipment complies with national standards.
(3)The Analyzer is operated according to the manual.
No further notice will be provided in case of any changes to the software interface.
User’s Manual
Contents
Chapter 1 Introduction ...................................................................................................................1-1

1.1 General ............................................................................................................................................................ 1-1
1.2 Normal operating conditions ......................................................................................................................... 1-1
1.3 Key indicators ................................................................................................................................................. 1-1
1.4 Working principle ........................................................................................................................................... 1-2
1.4.1 Sample aspirating .............................................................................................................................................................. 1-2
1.4.2 Sample dilution ................................................................................................................................................................. 1-2
1.4.3 White blood cell measurement .......................................................................................................................................... 1-4
1.4.4 Hemoglobin concentration measuring ............................................................................................................................... 1-5
1.4.5 Red blood cell/ platelet measurement ................................................................................................................................ 1-5
1.4.6 Flush .................................................................................................................................................................................. 1-7
1.5 Structure of the Analyzer ............................................................................................................................... 1-7
1.5.1 Front view of the Analyzer ................................................................................................................................................ 1-8
1.5.2 Rear view of the Analyzer ................................................................................................................................................. 1-8
1.5.3 Left view of the Analyzer .................................................................................................................................................. 1-9
1.6 External device of the Analyzer ..................................................................................................................... 1-9
1.7 Symbol ............................................................................................................................................................. 1-9
1.8 Identification ................................................................................................................................................. 1-10
Chapter 2 Installation .....................................................................................................................2-1
2.1 Mounting requirements .................................................................................................................................. 2-1
2.1.1 Space requirements............................................................................................................................................................ 2-1
2.1.2 Power requirements ........................................................................................................................................................... 2-1
2.1.3 Environmental requirements.............................................................................................................................................. 2-1
2.2 Unpacking........................................................................................................................................................ 2-1
2.2.1 Unpacking steps ................................................................................................................................................................ 2-1
2.2.2 Way of handling ................................................................................................................................................................ 2-2
2.3 Installation of the Analyzer ............................................................................................................................ 2-2
2.3.1 Pipe connection ................................................................................................................................................................. 2-3
2.3.2 Connect Machine............................................................................................................................................................... 2-3
2.3.3 Power cord connection ...................................................................................................................................................... 2-3
2.3.4 Printing paper installation.................................................................................................................................................. 2-3
2.3.5 Bar code reader connection ............................................................................................................................................... 2-4
2.3.6 Printer Connections ........................................................................................................................................................... 2-4
2.4 Turn-on and user login ................................................................................................................................... 2-4
2.4.1 User login .......................................................................................................................................................................... 2-4
2.4.2 Introduction to the main interface...................................................................................................................................... 2-7
2.5 Gas & liquid path diagrams......................................................................................................................... 2-10
Chapter 3 System settings ..............................................................................................................3-1
3.1 General ............................................................................................................................................................ 3-1
3.2 Mode settings................................................................................................................................................... 3-1
3.3 Unit setup......................................................................................................................................................... 3-1
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3.4 Reference value settings ................................................................................................................................. 3-3

3.5 Abnormity identification settings .................................................................................................................. 3-4
3.6 QC settings ...................................................................................................................................................... 3-6
3.6.1 QC method ........................................................................................................................................................................ 3-6
3.6.2 L-J settings ........................................................................................................................................................................ 3-6
3.6.3 Xbar settings...................................................................................................................................................................... 3-7
3.6.4 X-B settings ....................................................................................................................................................................... 3-8
3.7 Information settings ....................................................................................................................................... 3-9
3.8 User settings .................................................................................................................................................. 3-13
3.9 Instrument settings ....................................................................................................................................... 3-16
3.9.1 Sleep settings ................................................................................................................................................................... 3-16
3.9.2 Automatic rinsing settings ............................................................................................................................................... 3-16
3.9.3 Blocked hole settings....................................................................................................................................................... 3-17
3.10 Software settings ......................................................................................................................................... 3-18
3.10.1 Date format settings....................................................................................................................................................... 3-18
3.10.2 Print settings .................................................................................................................................................................. 3-18
3.10.3 Network settings ............................................................................................................................................................ 3-19
3.10.4 Language settings .......................................................................................................................................................... 3-20
3.10.5 Other settings................................................................................................................................................................. 3-21
Chapter 4 Calibration.....................................................................................................................4-1
4.1 General ............................................................................................................................................................ 4-1
4.2 Calibration frequency .................................................................................................................................... 4-1
4.3 Calibration method......................................................................................................................................... 4-1
4.4 Calibrator calibration .................................................................................................................................... 4-1
4.4.1 Input of calibrator reference value..................................................................................................................................... 4-2
4.4.2 Calibration counting .......................................................................................................................................................... 4-2
4.4.3 Save calibration coefficient ............................................................................................................................................... 4-3
4.5 Fresh blood calibration .................................................................................................................................. 4-5
4.5.1 Preparation of fresh blood ................................................................................................................................................. 4-5
4.5.2 Calibration counting .......................................................................................................................................................... 4-5
4.5.3 Save calibration coefficient ............................................................................................................................................... 4-6
4.6 Manual calibration ......................................................................................................................................... 4-7
4.7 Calibration history ......................................................................................................................................... 4-8
Chapter 5 Quality control ..............................................................................................................5-1
5.1 General ............................................................................................................................................................ 5-1
5.2 L-J QC ............................................................................................................................................................. 5-1
5.2.1 Settings .............................................................................................................................................................................. 5-2
5.2.2 QC counting ...................................................................................................................................................................... 5-3
5.2.3 QC diagram ....................................................................................................................................................................... 5-5
5.2.4 QC list ............................................................................................................................................................................... 5-7
5.3 Xbar QC .......................................................................................................................................................... 5-9
5.4 X-B QC ............................................................................................................................................................ 5-9
5.4.1 Settings .............................................................................................................................................................................. 5-9
5.4.2 QC diagram ..................................................................................................................................................................... 5-10
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5.4.3 QC list ............................................................................................................................................................................. 5-11

5.5 XBAR-R QC .................................................................................................................................................. 5-12
5.5.1 Settings ............................................................................................................................................................................ 5-12
5.5.2 QC counting .................................................................................................................................................................... 5-13
5.5.3 QC diagram ..................................................................................................................................................................... 5-15
5.5.4 QC list ............................................................................................................................................................................. 5-17
Chapter 6 Sample registration .......................................................................................................6-1

6.1 General ............................................................................................................................................................ 6-1
6.2 Edit info. .......................................................................................................................................................... 6-1
6.2.1 Sample information ........................................................................................................................................................... 6-2
6.2.2 Patient information ............................................................................................................................................................ 6-2
6.3 Download worklist .......................................................................................................................................... 6-3
6.4 Delete worklist................................................................................................................................................. 6-4
Chapter 7 Routine operation .........................................................................................................7-1
7.1 General ............................................................................................................................................................ 7-1
7.2 Preparations for operation ............................................................................................................................. 7-1
7.3 Turn on ............................................................................................................................................................ 7-1
7.4 Daily QC .......................................................................................................................................................... 7-2
7.5 Sample preparation ........................................................................................................................................ 7-2
7.5.1 Whole-blood sample.......................................................................................................................................................... 7-2
7.5.2 Peripheral blood sample .................................................................................................................................................... 7-2
7.6 Whole-blood sample analysis ......................................................................................................................... 7-3
7.7 Analysis of pre-dilution samples .................................................................................................................... 7-5
7.8 Parameter alarm ............................................................................................................................................. 7-6
7.8.1 Parameter alarm type ......................................................................................................................................................... 7-6
7.8.2 Abnormal alarm for classification or morphology ............................................................................................................. 7-6
7.9 Sleep ................................................................................................................................................................. 7-6
7.10 Rinsing and unblocking................................................................................................................................ 7-6
7.11 Shutdown ....................................................................................................................................................... 7-7
Chapter 8 Results query .................................................................................................................8-1
8.1 General ............................................................................................................................................................ 8-1
8.2 Record selection .............................................................................................................................................. 8-1
8.3 Query ............................................................................................................................................................... 8-2
8.4 Audit and cancel audit .................................................................................................................................... 8-2
8.5 LIS transmission ............................................................................................................................................. 8-2
8.6 Delete ............................................................................................................................................................... 8-2
8.7 Image review ................................................................................................................................................... 8-3
8.7.1 Edit information ................................................................................................................................................................ 8-3
8.7.2 Edit result .......................................................................................................................................................................... 8-4
8.7.3 Histogram adjustment........................................................................................................................................................ 8-5
Chapter 9 System maintenance .....................................................................................................9-1
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User’s Manual
9.1 General ............................................................................................................................................................ 9-1

9.2 Maintenance Guide......................................................................................................................................... 9-1
9.2.1 Regular maintenance ......................................................................................................................................................... 9-1
9.2.2 Timely maintenance .......................................................................................................................................................... 9-2
9.3 System maintenance ....................................................................................................................................... 9-2
9.3.1 Basic status with ................................................................................................................................................................ 9-2
9.3.2 Pressure ............................................................................................................................................................................. 9-3
9.3.3 System Version .................................................................................................................................................................. 9-4
9.3.4 Mechanical detection ......................................................................................................................................................... 9-4
9.3.5 Services ............................................................................................................................................................................. 9-5
9.3.6 HGB verification ............................................................................................................................................................. 9-12
9.3.7 Data backup ..................................................................................................................................................................... 9-13
9.3.8 Counter ............................................................................................................................................................................ 9-13
9.4 Maintenance of the instrument before stopping using .............................................................................. 9-14
9.5 Rinsing and maintenance of the instrument............................................................................................... 9-14
9.6 Disposal of waste liquid ................................................................................................................................ 9-15
9.7 Disposal of scrapped instruments................................................................................................................ 9-15
Chapter 10 System log ..................................................................................................................10-1
10.1 System log .................................................................................................................................................... 10-1
Chapter 11 Reagent management ............................................................................................... 11-1
11.1 Reagent registration ................................................................................................................................... 11-1
11.2 Reagent settings .......................................................................................................................................... 11-3
Chapter 12 Alarm information and processing ..........................................................................12-1
12.1 General ........................................................................................................................................................ 12-1
12.2 Alarm information and troubleshooting ................................................................................................... 12-2
Chapter 13 Transportation and storage ......................................................................................13-1
13.1 Transportation ............................................................................................................................................ 13-1
13.2 Storage ......................................................................................................................................................... 13-1
Appendix A Network communication interface protocol V1.1 .................................................. A-1
Appendix B Letter of guarantee ................................................................................................... B-1
Appendix C Product description .................................................................................................. C-1
Appendix D Performance index ................................................................................................... D-1
Appendix E Parts list ..................................................................................................................... E-1
Appendix F Statement on electromagnetic compatibility .......................................................... F-1
IV
User’s Manual
Chapter 1 Introduction
1.1 General
The Automatic Hematology Analyzer (model: BCC-3900/BCC-3960) is designed and produced based on the idea
of accurate measurement, simple operation and low material consumption, conforming to users' requirements. The
Analyzer can provide quantitative analysis results of 21 parameters.
Applicable scope of the Analyzer: It can count the number of white blood cells, red blood cells and platelets in
blood sample with impedance method and have 3-diff of white blood cells, test the hemoglobin concentration with
colorimetric method and calculate hemocyte related parameters.
Contraindications: None.
1.2 Normal operating conditions

(1)Power voltage & frequency: 100-240V~, 50/60Hz
(2)Ambient temperature: 10℃~35℃.
(3)Relative humidity: Not exceeding 85%.
(4)Atmospheric pressure: 75kPa~106kPa.
(5)Altitude: Not greater than 2000m.
(6)No frost, condensation, water seepage, rain and solar exposure.
1.3 Key indicators

Type
Metrics
BCC-3900 BCC-3960
WBC, NEU#, LYM#, MXD#, NEU%,

WBC, NEU#, LYM#, MXD#, NEU%,
LYM%, MXD%, RBC, HGB, MCV,
LYM%, MXD%, RBC, HGB, MCV, MCH,
Test Item MCH, MCHC, RDW-CV, RDW-SD,
MCHC, RDW-CV, RDW-SD, HCT, PLT,
HCT, PLT, MPV, PDW, PCT, P-LCR,
MPV, PDW, PCT, P-LCR, P-LCC
P-LCC
3-diff of white blood cell, test of 21 3-diff of white blood cell, test of 21
parameters, 3 histograms, prompt and parameters, 3 histograms, prompt and alarm
Parameter
alarm functions in case of pathological functions in case of pathological and
and morphological abnormalities. morphological abnormalities.
BASE
Features Test speed 70 samples/ hour 70 samples/ hour
Sample feeding
Manual sample feeding Manual sample feeding
way
Sample storage
At least 500000 At least 200000
volume
Sample bar code Automatic recognition or manual input Automatic recognition or manual input
2 types, including 1 type of diluent and 1 2 types, including 1 type of diluent and 1
Reagent type
type of lyse type of lyse
Measurement of Hemoglobin measurement with Hemoglobin measurement with

Reagents hemoglobin cyanogen-free compound cyanogen-free compound
Systems It alarms when there is no reagent or the It alarms when there is no reagent or the
Reagent alarm
reagent is expired. reagent is expired.
Bar code of An external bar code reader or input An external bar code reader or input
reagent manually manually
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User’s Manual
Type
Metrics
BCC-3900 BCC-3960
Impedance method is adopted for

White blood cell Impedance method is adopted for counting
counting of white blood cells and white
classification of white blood cells and white blood cells are
blood cells are classified based on cell
ANALYSIS principle classified based on cell volume.
volume.
Systems Impedance method for WBC, RBC and
Impedance method for WBC, RBC and PLT;
Counting method PLT;
Colorimetric method for HGB
Colorimetric method for HGB
Interfaces RJ45 network interface, USB interface RJ45 network interface, USB interface
Data
Systems Connection with
Supported Supported
LIS/HIS system
Weight 25kg 25kg

Whole
Boundary 430mm×295mm×398mm 430mm×295mm×398mm
machine
dimension (D×W×H) (D×W×H)
Systems
Power
110VA 110VA
Consumption
1.4 Working principle

The Analyzer applies the electrical impedance method to test the number and volume distribution of red blood cell,
white blood cell and platelet and applies colorimetric method to test the hemoglobin concentration. On this basis,
it calculates the results of other parameters.
1.4.1 Sample aspirating
Under the whole-blood mode, the operator can send the whole-blood sample to the instrument for sampling
directly. At the moment aspirate 6μL whole blood samples.
Under micro whole blood mode, the operator can send the micro whole blood sample to the instrument for
sampling directly. At the moment aspirate 6μL micro whole blood samples.
Under pre-dilution test mode, the operator shall mix the 20μL peripheral blood sample with 0.7mL dilute outside
the Analyzer to form a diluted sample (dilution ratio: 1:36), and then send the diluted sample to the Analyzer for
sampling. At the moment, aspirate 0.216mL diluted samples.
1.4.2 Sample dilution
Generally, as different cells in the sample to be tested overlap and the instrument fails to accurately calculate the
number or the volume distribution of blood cells, before the instrument starts counting or calculating the volume
distribution of blood cells, the sample should be diluted to ensure the blood cells after dilution can pass the test
holes individually and provide a conducting environment for counting so as to finish the measurement of number
and volume of cells. Generally, the number of red blood cells is 1000 times of that of white blood cells and the
disturbance from red blood cells shall be eliminated first before metering white blood cells, thus before
calculating the number of white blood cells, lyse shall be dispensed to diluted white blood cell sample to dissolve
red blood cell membrane first. For different test samples, the Analyzer provides three test modes, whole blood test
mode, micro whole blood mode and pre-dilution (peripheral blood) test mode.
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User’s Manual
1.4.2.1 Whole-blood mode
Whole blood sample 6 μL
Diluent 1.9 mL
Sample of diluent ratio being about

1:317
Lyse 1 mL Diluent about 2.2 mL
WBC sample of diluent ratio being RBC/PLT sample of diluent ratio

about 1:487 being about 1:17789
Fig. 1-4-1 Dilution process of whole blood mode

As shown in the figure above, under the whole blood mode, the 6μL whole blood sample aspirated by the
instrument is mixed with 2mL diluent to form a diluted sample with dilution ratio of about 1:317. The diluted
sample will be divided into two parts for use. 40μL of it will be mixed with 2.2mL diluent again to form a count
sample with dilution ratio of about 1:17789 to be used for calculating the number of red blood cells and platelets.
The rest diluted sample will be mixed with 1mL lyse to form a count sample with dilution ratio of about 1:487 to
be used for measuring hemoglobin concentration and calculating number of white blood cells.
The dilution process of micro whole blood mode is the same with the dilution process of whole blood mode.
1.4.2.2 Pre-dilution mode
20 μL peripheral blood sample
0.7 mL Diluent
Sample of Diluent ratio being

about 1:36
2 mL Diluent
Sample of Diluent ratio being

about 1:334
1 mL Lyse Diluent, about 2.2

mL
WBC sample of Diluent ratio RBC/PLT sample of Diluent

being about1:504 ratio being about1:18,389
Fig. 1-4-2 Dilution process of pre-dilution mode

As shown in the figure above, under the pre-dilution mode, the 20μL peripheral blood is mixed with 0.7mL
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User’s Manual
diluent (dilution outside machine) to form a diluted sample with dilution ratio of about 1:36. 0.216mL diluted
sample aspirated by the instrument is mixed with 2mL diluent to form a diluted sample with dilution ratio of about
1:334. The diluted sample will be divided into two parts for use. 40μL of it will be mixed with 2.2mL diluent
again to form a count sample with dilution ratio of about 1:18389 to be used for calculating the number of red
blood cells and platelets. The rest diluted sample will be mixed with 1mL lyse to form a count sample with
dilution ratio of about 1:504 to be used for measuring hemoglobin concentration and calculating number of white
blood cells.
1.4.3 White blood cell measurement
1.4.3.1 White blood cell counting principle
The instrument uses electrical impedance method to count the white blood cell. After a certain amount of aspirated
sample is diluted in a certain amount of conducting solution, it will be sent to the test unit of the Analyzer. The test
unit has a test hole. At the two sides of the hole, there is a pair of positive and negative electrode to connect
constant current power supply. As the cells have the features of poor conductor, the DC resistance between
electrodes will change when the cells in diluted sample pass the small detection hole under constant negative
pressure and pulse changes in proportion to the cell volume and size will be formed at the two ends of electrode.
When cells pass the small hole continuously, a string of electric pulses will be generated at two ends of the
electrode. The number of pulses and the number of cells passing the small hole are equivalent and the pulse
magnitude is in direct proportion to the volume of cell.
After the collected electric pulse is amplified, it is compared with the channel voltage range corresponding to the
volume range of normal white blood cell. And then, the number of electric pulses of pulse amplitude in white
blood cell channel will be calculated. The collected electric pulses are classified according to different channel
voltage range and the number of electric pulses in white blood cell channel is just the number of white blood cells.
The number of cells in each channel divided according to the pulse voltage range determines the volume
distribution of cells.
Fig. 1-4-3 Counting principle diagram

1.4.3.2 White blood cell parameters
(1)Number of white blood cell
The Analyzer gets the number of white blood cells (WBC) by the direct measurement of the number of electric
pulses of white blood cell, and the unit is 109/L.
WBC  n  109 / L
(2)3-diff of white blood cell

According to the principle of the electrical impedance method, it can be known that cells of different volumes
generate different impulses when passing small holes while different white blood cells have obviously different
volume after having interaction with lyse. Therefore, the white blood cells in blood can be manually classified into
two types, i.e. cellule, intermediate cell and maxicell according to the impulses.
(3)White blood cell distribution histogram
The instrument also gives the volume distribution histogram of white blood cells while providing the number
counting results of white blood cells. On the histogram, the abscissa shows the volume of white blood cells (unit:
fL) and the ordinate shows the relative number of white blood cells (unit: 109/L). After each counting, the white
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User’s Manual
blood cell distribution histogram can be checked in the analysis results area on counting interface or by query on
the query interface.
1.4.4 Hemoglobin concentration measuring
1.4.4.1 Hemoglobin concentration measuring principle
SLS-hemoglobin method combines the cationic surface active agent and hemoglobin. The hemoglobin has a quick
conversion speed and does not adopt poisonous substances. It is suitable for automatic detection instruments.
The hemoglobin concentration shall be measured with the SLS-hemoglobin method. In a colorimeter cell, after
the diluted sample is dispensed to lyse, the red blood cell will dissolve and generate hemoglobin. The combination
of the hemoglobin and lyse will generate hemoglobin compound. On one end of the colorimeter cell, LED
luminotron passes a monochromatic light with wavelength of 540nm to reflect the hemoglobin compound solution.
On the other end, it passes phototube to receive transmission light and converts the light intensity signal to voltage
signal after amplification. Through the comparison with the voltage generated by the transmission light intensity
before the sample is dispensed to the colorimeter cell (only diluent in the colorimeter cell), the hemoglobin
concentration (HGB) of sample can be obtained and the unit is g/L. The measurement and calculation are
completed by the Analyzer automatically and the results will be displayed in the analysis results area on the
counting interface.
1.4.4.2 Hemoglobin concentration parameters
Hemoglobin concentration (HGB) (unit: g/L)
Background transmission intensity
HGB  Constant  Log10
Sample transmission intensity
1.4.5 Red blood cell/ platelet measurement

1.4.5.1 Electrical impedance method
The Analyzer uses the electrical impedance method to count red blood cells/ platelets (as shown in Fig. 1-4-4).
The red blood cell/ platelet sample will enter RBC test unit after secondary dilution. The test unit has a small hole
for test. At the two sides of the hole, there is a pair of positive and negative electrode to connect constant current
power supply. As the cells have the features of poor conductor, the DC resistance between electrodes will change
when the cells in diluted sample pass the small detection hole under constant negative pressure and pulse signal in
proportion to the cell volume and size will be formed at the two ends of electrode. When cells pass the small hole
continuously, a string of electric pulses will be generated at two ends of the electrode. The number of pulses and
the number of cells passing the small hole are equivalent and the pulse magnitude is in direct proportion to the
volume of cell.
Fig. 1-4-4 Counting principle diagram

After the collected electric pulse is amplified, it is compared with the channel voltage threshold corresponding to
the volume range of normal red blood cell/ platelet. And then, the number of electric pulses of pulse amplitude in
red blood cell/ platelet channel will be calculated. The collected electric pulses are classified according to different
channel voltage threshold and the number of electric pulses in red blood cell/ platelet channel is just the number of
red blood cells/ platelets. The number of cells in each channel divided according to the pulse voltage range
determines the volume distribution of cells. The abscissa shows the volume of cell and the ordinate shows the 2D
diagram of cell quantity, i.e. the histogram reflecting the cell group distribution.
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User’s Manual
1.4.5.2 Red blood cell parameters

(1)Number of red blood cells
The Analyzer gets the number of red blood cells (RBC) by the direct measurement of the number of electric
pulses of red blood cell, and the unit is 1012/L.
RBC  n  1012 / L
(2)Mean red blood cell volume
The Mean red blood cell volume (MCV) can be calculated according to the red blood cell distribution histogram,
and the unit is fL.
(3)Red blood cell hematocrit, mean red blood cell hemoglobin content, mean red blood cell hemoglobin
concentration
With the formulas below, the red blood cell hematocrit (HCT) (unit: %), mean red blood cell hemoglobin content
(MCH) (unit: pg) and mean red blood cell hemoglobin concentration (MCHC) (unit: g/L) can be calculated.
Hematocrit:
RBC  MCV
HCT 
10
Mean red blood cell hemoglobin content (MCH):
HGB
MCH =
RBC
Mean red blood cell hemoglobin concentration (MCHC)
HGB
MCHC   100
HCT
The unit of RBC is 1012/L, the unit of MCV is fL and the unit of HGB is g/L.
(4)Red blood cell distribution width variation coefficient
The red blood cell distribution width variation coefficient (RDW-CV) is obtained from the red blood cell
distribution histogram. It is a variation coefficient showing volume distribution in percentage.
(5)Standard deviation of red blood cell distribution width
The deviation limit of red blood cell distribution width (RDW-SD) is the width at peak 20% in histogram of red
blood cell distribution and the unit is fL, as shown in the figure.
Fig. 1-4-5 Diagram

(6)Red blood cell distribution histogram
The Analyzer can provide a red blood cell volume distribution graph while providing the red blood cell counting
results. The graph that shows the distribution of cells is called red blood cell distribution histogram. On the
histogram, the abscissa shows the volume of red blood cell (unit: fL) and the ordinate shows the relative number
of red blood cell (unit: 1012/L). After each counting, the red blood cell distribution histogram can be checked in
the analysis results area on counting interface or by query on the query interface.
1.4.5.3 Platelet parameters
(1)Platelet number (PLT)
The Analyzer gets the number of platelets by the direct measurement of the number of electric pulses of platelet,
and the unit is 109/L.
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PLT  n  109 / L
(2)Mean platelet volume (MPV)
The mean platelet volume can be calculated according to the platelet distribution histogram, and the unit is fL.
(3)Platelet distribution width (PDW)
The platelet distribution width is obtained from the platelet distribution histogram and it is geometric deviation
limit (10GSD) of platelet volume distribution.
(4)Platelet hematocrit (PCT)
The Analyzer calculates the platelet hematocrit (unit: %) with the formula below. The unit of PLT is 109/L and the
unit of MPV is fL.
PLT  MPV
PCT 
10000
(5)Proportion of large platelet (P-LCR)
The proportion of large platelet can be obtained from the platelet histogram. It is the proportion of large platelet in
platelet.
(6)Large platelet counts (P-LCC)
The count of large platelet can be obtained from the platelet histogram. It is the count of large platelets in platelet.
(7)Platelet distribution histogram
The Analyzer can provide a platelet volume distribution graph while providing the platelet counting results. The
graph that shows the distribution of cells is called platelet distribution histogram. On the histogram, the abscissa
shows the volume of platelet (unit: fL) and the ordinate shows the relative number of the platelet (unit: 109/L).
After each counting, the platelet distribution histogram can be checked in the analysis results area on counting
interface or by query on the query interface.
1.4.6 Flush
The Analyzer will rinse the components where sample flows automatically in each counting period to ensure no
sample left in liquid path.
(1)The internal and external sides of the aspiration probe are rinsed with diluent.
(2)The count cell is rinsed with diluent.
1.5 Structure of the Analyzer

Composition: Host (including mechanical system, liquid path system, electronic control system and software
system) and auxiliary system (human-computer interaction interface and external barcode reader).
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1.5.1 Front view of the Analyzer
1 Front door 2 Display screen 3 Sample probe 4 Buttons 5 Printer cover

Fig. 1-5-1 Front view of the Analyzer
1.5.2 Rear view of the Analyzer
1 Upper cover assembly 2 Right door assembly vent port 3 Back plate 4 RJ45 port
5 USB interface 6 USB interface 7 Power supply (Switch, filter and socket) 8 Left door assembly
9 Right door assembly 10 Diluent port 11 Waste liquid port
Fig. 1-5-2 Rear view of the Analyzer
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1.5.3 Left view of the Analyzer
1 Reagent door 2 Reagent door catch

Fig. 1-5-3 Left view of the Analyzer
1.6 External device of the Analyzer

(1)Printer: It is connected with the instrument directly and it prints reports through the software of the instrument.
The instrument supports the following printer:
HP LaserJet Pro 400 M401d.
(2)Bar code reader: It is connected with the instrument directly and it can input the bar code information quickly.
The bar code reader is included in the standard configuration.
1.7 Symbol
Table 1-7-1
Symbols Meaning
Biohazard, reminding the user to pay attention; otherwise there is risk of potential
bio-infectivity
ALTERNATING CURRENT
IN VITRO DIAGNOSTIC MEDICAL DEVICE
BATCH CODE
USE BY
SERIAL NUMBER
DATE OF MANUFACTURE
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Symbols Meaning
MANUFACTURER
THE DEVICE MEETS THE REQUIREMENTS OF DIRECTIVE ON IN VITRO

DIAGNOSTIC MEDICAL DEVICES
AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
CAUTION, REFER TO THE ACCOMPANYING FILES OR MARK DETAILED

WARNING OR MATTERS NEEDING ATTENTION
CATALOGUE NUMBER
Do not contact the sampling probe when the instrument is working.
"ON" (POWER)
"OFF" (POWER)
PROTECTIVE EARTH
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.
Temperature limit
Humidity limitation
Atmospheric pressure limitation
Caution, hot surface
The symbols above are also applicable to the Analyzer, reagent, QC object and calibration object.
1.8 Identification
(1)
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Chapter 2 Installation
To ensure the normal operation of the Analyzer after the installation, the Analyzer shall be installed by the
authorized operators of the manufacturer at the delivery.
2.1 Mounting requirements

The Analyzer can only be installed after the following space, power and environmental requirements are met. The
Analyzer shall be placed on a horizontal operation platform instead of a sloping platform. The platform shall
withstand 25kg at least.
Remarks: Weight of host: 25kg.
2.1.1 Space requirements
For a proper servicing and repair of the Analyzer, following conditions shall be met when the Analyzer is
installed:
(1)The distance from the instrument at its left and right sides to the wall shall not be shorter than 50cm.
(2)The distance from the rear panel of the instrument to the wall shall not be shorter than 50cm.
(3)The distance from the front instrument to other instruments shall not be shorter than 100cm.
(4)Sufficient space shall be guaranteed on the operation platform or under the Analyzer for placing collecting
devices of diluent, reagent and waste liquid.
2.1.2 Power requirements
(1)Power voltage & frequency: 100-240V~, 50/60Hz.
(2)Power consumption: 110VA.
(3)Fuse specification: F4AL250V 5mm×20mm.
(4)To maintain its successful operation, the power supply shall be reliably grounded and do not plug the Analyzer
into the same receptacle with electrical equipment with a heavy load such as air conditioner, refrigerator and oven.
2.1.3 Environmental requirements
(1)Ambient temperature: 10℃~35℃.
(2)Relative humidity: Not exceeding 85%.
(3)Atmospheric pressure: 75kPa~106kPa.
(4)The Analyzer shall be put in a dust-free environment without mechanical vibration, source of large noise and
power interference.
(5)It is recommended to evaluate the electromagnetic environment in laboratory before operating the Analyzer.
(6)Do not have the Analyzer closing to the interference source of high electromagnetic, lest it may interfere the
normal operation of the Analyzer.
(7)Do not put the Analyzer near brush motor, scintillant fluorescent lamp and electrical contact equipment often
used.
(8)The Analyzer shall be prevented from direct sunlight exposure and not be placed near heat and wind sources.
(9)The environment shall be well-ventilated and the ventilating device shall be used if necessary. But the Analyzer
should be protected from the direct airflow, otherwise, the test accuracy may be affected.
If the operating environment or power supply of the instrument does not meet requirements above, the
accuracy and precision of test results of the instrument may be affected, the instrument may be damaged or
personal injury may be caused.
2.2 Unpacking
2.2.1 Unpacking steps
After the arrival of the Analyzer, please carefully check the physical damage of the Analyzer package, if the
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package is damaged, please contact the manufacturer or local distributor. After ensuring there is no outer damages,
please unpack according to following steps:
(1)Put the package upright as the arrow indicates.
(2)Take out the Analyzer case and accessory case and check materials inside based on the packing list. If any
goods missed, please contact the manufacturer or local distributor.
2.2.2 Way of handling
(1)Use transport machine such as utility trolley for the stable transportation of short distance.
(2)Prevent the aspiration probe from other objects and being damaged during handling and transportation
processes.
(3)Keep the Analyzer vertical, not tilting or side laying when moving and carrying.
(4)Try to avoid vibration when handling.
2.3 Installation of the Analyzer
It is recommended to users that do not disassemble or install the instrument except for the normal
maintenance.
1 Diluent port 2 Waste liquid port

Fig. 2-3-1 Connection of the instrument and reagent
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1 Lyse port
Fig. 2-3-2 Connection with reagent inside the instrument
2.3.1 Pipe connection

Open the reagent door of the instrument, put the lyse bottle in the instrument and connect them in accordance with
signs in Fig. 2-3-2.
Place the diluent tank and waste liquid tank of the instrument under the operation platform and connect them in
accordance with signs in Fig. 2-3-1.
● The height difference between the waste liquid tank and the waste liquid port of the instrument shall not
be less than 0.5m.
● The waste liquid shall be discharged in accordance with the local regulations on the disposal of medical
waste.
● The drainage system shall be in compliance with the local regulations with regard to sewage discharge
and treatment of medical institutions.
2.3.2 Connect Machine
To connect the computer, use a network cable accompanying the instrument to connect the "network interface" of
the computer with the "RJ45 network interface" on the back of the Analyzer (4 in Fig. 1-5-2).
2.3.3 Power cord connection
Plug one end of the accompanying power cable into the power socket of the Analyzer (4 in Fig. 2-3-1), and plug
the host power cable, display power cable and printer power cable.
● The receptacle connected with the power cable shall be reliably grounded.
● Do not put the instrument at a place where the disconnecting device is hard to be operated.
2.3.4 Printing paper installation
(1)Choose the thermal printing paper with 57mm width and smaller than 50mm of the diameter.
(2)Open the printer hood.
(3)Put printing papers into the printing paper box and keep the paper outlet near the inside of the instrument.
(4)Put one side of the printing paper at the bottom of the rolling bar, and printing papers will move through the
rolling bar automatically when the bar is rolling.
(5)Put the paper through the paper outlet of the printer hood and cover the printer.
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2.3.5 Bar code reader connection

Connect another end of accompanying bar code reader with any "USB" interface on the instrument.
The bar code reader will emit light harmful to people's eyes, please do not look straight at the light when
the Analyzer is working.
2.3.6 Printer Connections
Use a data cable to connect the printer and the USB interface of the Analyzer correctly and check the specification
of printing paper used by the printer.
Plug one end of the printer power cable to the supply socket of the printer and plug the other end to the socket.
In the transportation process, to prevent damage to the aspiration probe, moving mechanisms of the
instrument have been fixed when the instrument is delivered. Before the instrument is powered on, the
fixing screws and tie shall be removed first, or the aspiration probe may be damaged.
2.4 Turn-on and user login

Operating environment requirements: ARM
Software environment: Linux
Network conditions: LAN data exchange and transmission, LAN relatively independent, physically isolated from
other network devices.
Data and device (system) interfaces:
The software exchanges data through hardware devices. These hardware devices include USB flash drives and SD
card storage devices. The software imports data through peripheral USB interfaces or SD cards.
Data exchange and transmission between PC and embedded software components can be realized via the LIS
system in TCP LAN.
User access control mechanism: In order to ensure the safety of products and data, the instrument divides
operators into two levels of authority, i.e., users and the administrators (the administrator has all the rights over the
user).
2.4.1 User login
Turn on the power switch and the display will show "System Loading…". After the system finishes initialization,
a login dialog box will pop up, as shown in the figure:
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Fig. 2-4-1
In the login dialog box, input correct user name and password, the initial user name of instrument is admin, and
the initial password is 1, if wrong user name and password are input, login failure will appear, and the interface is
as shown in the figure below:
Fig. 2-4-2
The user name and the password are composed of lower and upper case English letters or figures (1-12
characters).
After logging in, the instrument enters the initialization interface to initialize. It performs version verification,
mechanical reset, reagent residue detection, transmission gain, pipeline rinsing, background detection, and blank
test, as shown in the figure below:
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Fig. 2-4-3
● The blank result obtained during the blank test is beyond the range set by the software and the
instrument will perform the blank test again. If the result is still not qualified after tested twice, "blank test
error" will be prompted.
● The instrument will not have High value, Low value or Suspicious alarms for the blank test results.
● When the power-on self-check alarm triggers, the instrument enters the main interface and prompts
corresponding alarm information. After the alarm is cleared, the instrument performs self-check again.
After the instrument finishes the self-check, enter the main window of the software, as shown in the figure below:
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Fig. 2-4-4
2.4.2 Introduction to the main interface

2.4.2.1 Menu
Click the [Menu] to pop up the menu as shown in Fig. 2-4-4. The functions in the menu bar are described as
follows:
Fig. 2-4-5
Sample registration: Have sample registration and work list input.
Calibration: Calibrate the instrument.
QC: L-J/Xbar, Xbar-R and X-B.
Maintenance: Check the status of the instrument and have maintenance and check of the instrument.
Settings: Set parameters of the instrument.
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Log: Record system operating information and error information.

Reagent: reagent registration and reagent information settings.
Logout: Switch between users and log in software interface with a new user identity.
Shutdown: Turn the instrument off.
2.4.2.2 Public information area
The public information area is shown in the lower part of the counting interface, as shown in figure below
Total number of locations Current mode Test status

Fig. 2-4-6
(1)Total number of locations: Display the current sample serial number and total sample size
(2)Current status: Display the analysis mode of the sample.
Analysis mode: There are totally three analysis modes, respectively whole blood mode, micro-whole blood mode
and pre-dilution mode.
(3)Test status: Indicate the current status of the instrument.
2.4.2.3 Status indication area
On the right side of Fig. 2-4-6 is the status indication area. The area displays in sequence the X-B switch status, U
disk connection status, LIS system connection status, and external printer connection status, described as follows:
(1)X-B QC switch status:
: The X-B quality control is on.
: The X-B quality control is not turned on.

(2)USB status:
:The USB storage device is connected.
: The USB storage device is not yet connected.

(3)LIS system connection status:
: The LIS is connected.
: The LIS is not yet connected.

(4)External printer connection status:
: The printer is connected.
: The printer is not yet connected.

2.4.2.4 Shortcut area
Fig. 2-4-7
(1)Sample analysis: Finish sample test and the analysis and display of test results on the interface.
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(2)History: The instrument will automatically save the analysis results in the database after executing sample
analyzing each time. The operator can query all the sample results stored in the database.
(3)QC: Enter the QC interface to realize the basic settings of QC and QC counting.
(4)Add diluent: Dispense diluent for the preparation of pre-dilution sample under the pre-dilution mode.
(5)Rinse: Manually clean equipment.
(6)Print: Print the selected sample report form on the specified page, including sample analysis, history query,
quality control count, quality control chart, quality control list, etc.
(7)Fault information area:
In case of failures of the instrument, relevant failure level information will be displayed in the area. At the
moment, click the area to pop up a failure display dialog box, as shown in the figure below:
Fig. 2-4-8
After clicking relevant failure information, the detailed solution to the failure will be displayed in the "Alarm
help" and the user can have simple troubleshooting according the solution.
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2.5 Gas & liquid path diagrams
Fig. 2-5-1
Fig. 2-5-2
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Fig. 2-5-3
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Chapter 3 System settings
3.1 General
The system parameters of the instrument have had initialization settings in the factory. The interface shown at the
first turn-on of the instrument is the default interface. To meet different demands in actual use, the software sets
two identities, user and administrator. Users with different identities can rest different parameters.
3.2 Mode settings

Turn on the instrument, log in the software successfully, enter the counting interface and click the [Mode] in the
sample analysis interface area to pop up a mode settings dialog box, as shown in the figure below:
Fig. 3-2-1
(1)Next sample number: Enter the number of the next sample to be analyzed in the input box.
The sample number can only be entered in figure or "-", and its beginning and ending must be numeric
and up to 12 digits.
(2)Analysis mode: There are totally three analysis modes, respectively whole blood mode, micro-whole blood
mode and pre-dilution mode.
(3)Use worklist: Click to select and use the manually entered or downloaded worklist for testing.
(4)Automatic communication: After click and connection to the LIS, automatically transmit the test results.
3.3 Unit setup

Click [Menu] - [Settings] - [Unit], as shown in Fig. 3-3-1:
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Fig. 3-3-1
Click corresponding input box of the unit following each test item and select different units as the test units
according to actual demand.
After the input is completed, click [Save]. When the message "Saved successfully" is prompted, click [OK].
Click [Default] to restore the unit to the default settings.
Unit of each test item: several units for the settings of each test item of the instrument are available for the user to
choose according to the demand and specific settings unit is as shown in Table 3-3-1:
Table 3-3-1
Parameter Unit Numeric form Remarks

9
10 /L ***.** Default unit
103/μL ***.**
WBC
102/μL ****.*
/nL ***.**
LYM#, MXD#, NEU# 109/L ***.** Default unit
LYM%, MXD%, NEU% % **.* Default unit
1012/L **.** Default unit
106/μL **.**
RBC
4
10 /μL ****
/pL **.**
g/L *** Default unit
HGB g/dL **.*
mmol/L **.*
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Parameter Unit Numeric form Remarks
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
4
10 /μL ***.*
/nL ****
fL **.* Default unit

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

PCT
mL/L *.**
P-LCR % **.* Default unit

9
P-LCC 10 /L **.** Default unit
After the unit of the parameter is changed, the data format of the test result also changes.
3.4 Reference value settings

The instrument has general, adult male, adult female, child, newborn and five custom reference ranges, and the
default is "Ordinary." Each laboratory should select appropriate reference range according to the actual sample
condition and set appropriate reference interval.
Click [Menu] - [Settings] - [Reference], as shown in Fig. 3-4-1:
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Fig. 3-4-1
Input of reference value upper and lower limits:
Click corresponding input box of upper and lower limits following each test item and directly input the upper and
lower limits of corresponding test item.
After the input is completed, click [Save] to confirm. When the message "Saved successfully" is prompted, click
[OK].
Click [Default] to restore the default upper and lower reference values.
3.5 Abnormity identification settings

Click [Menu] - [Settings] - [Abnormal flag] and select [WBC], as shown in the figure below:
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Fig. 3-5-1
Select [RBC/PLT] and the interface is as shown in the figure below:
Fig. 3-5-2
Users can set the prompt range of WBC, RBC/ PLT abnormal alarm information.
After the values are input, click [Save] to save the settings or click [DEF] to restore the preset value.
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3.6 QC settings
3.6.1 QC method
Click [Menu] - [Settings] - [QC], as shown in the figure below:
Fig. 3-6-1
Users can select the QC mode. After saving the settings, click the [QC] in the shortcut key area to enter the
corresponding QC interface.
3.6.2 L-J settings
Select [L-J] and the interface is as shown in the figure below:
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Fig. 3-6-2
In the figure above, users can select the L-J QC calculation method and range:
(1)If "Absolute value" is selected for the calculation method, the deviation limit input will be displayed in the
form of absolute value, and 2SD or 3SD will be displayed in the "Range" as deviation limit.
(2)If "Percentage" is selected for the calculation method, the deviation limit input will be displayed in the form of
percentage, and 2CV or 3CV will be displayed in the "Range" as deviation limit.
3.6.3 Xbar settings
Select [Xbar], as shown in the figure below:
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Fig. 3-6-3
In the figure above, users can select the Xbar QC calculation method and range:
(1)If "Absolute value" is selected for the calculation method, the deviation limit input will be displayed in the
form of absolute value, and 2SD or 3SD will be displayed in the "Range" as deviation limit.
(2)If "Percentage" is selected for the calculation method, the deviation limit input will be displayed in the form of
percentage, and 2CV or 3CV will be displayed in the "Range" as deviation limit.
3.6.4 X-B settings
Select [X-B] and the interface is as shown in the figure below:
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Fig. 3-6-4
Users can select the X-B QC switch and sample quantity settings.
3.7 Information settings

Click [Menu] - [Settings] - [Information], as shown in the figure below:
Fig. 3-7-1
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(1)Department: Click [Add] in the figure to add department information in the popup interface as shown in the
figure below:
Fig. 3-7-2
Select the row where the department information to be deleted is, click the [Delete] in the figure to pop up the
prompt as shown in the figure below:
Fig. 3-7-3
Click [OK] to delete corresponding department information.
(2)Doctor: Select [Doctor], the interface shown in the figure below:
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Fig. 3-7-4
Click [Add] in the figure to add doctor information in the popup interface as shown in the figure below:
Fig. 3-7-5
Select the row where the doctor information to be deleted is, click the [Delete] in the figure to pop up the prompt
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Fig. 3-7-6
Click [OK] to delete corresponding doctor information.
(3)Charge: Select [Cost type], the interface shown in the figure below:
Fig. 3-7-7
Click [Add] in the figure to add charge information in the popup interface as shown in the figure below:
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Fig. 3-7-8
Select the row where the charge information to be deleted is, click the [Delete] in the figure to pop up the prompt
Fig. 3-7-9
Click [OK] to delete corresponding charge information.
When adding the department, doctor, and charge, it is not allowed to input special characters.
3.8 User settings

Click [Menu] - [Settings] - [User], as shown in the figure below:
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Fig. 3-8-1
(1)Add user: Click [Add user] in the figure to add user information as shown in the figure below:
Fig. 3-8-2
Fill in the user information according to the corresponding prompt and click [Save] to complete the operation.
● User settings are only visible to users with the Admin permission.
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● When adding a user, the administrator needs to note the followings:

(1)The existing user name cannot be added.
(2)The user account, name, and password cannot be null.
(2)Delete user: In Fig. 3-8-1, select the row of the user information to be deleted, and click [Delete user] to pop up
the prompt as shown in the figure below:
Fig. 3-8-3
Click [OK] to delete corresponding user information.
The currently logged in user cannot delete itself.

(3)Change password: In Fig. 3-8-1, select the row of the user information that you want to change your password
and click [Modify password], as shown in the figure below:
Fig. 3-8-4
In the figure, enter the old password and new password respectively, and click [Save] to save the modified
password.
The new password entered twice must be the same.

(4)Reset password: In Fig. 3-8-1, select the row of the user information that you want to reset your password, and
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click [Reset password] to pop up the following prompt:
Fig. 3-8-5
Click [OK] to reset the password. After the reset is successful, the new password is the same as the user name.
3.9 Instrument settings

3.9.1 Sleep settings
Click [Menu] - [Settings] - [Machine] and select [Sleep], as shown in the figure below:
Fig. 3-9-1
After [Time], you can set the instrument sleep time in [60,120] minutes.
3.9.2 Automatic rinsing settings
Click [Menu] - [Settings] - [Machine] and select [Auto-rinse], as shown in the figure below:
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Fig. 3-9-2
Input the number of automatic rinsing intervals 10~200 in the input box following "Count number".
3.9.3 Blocked hole settings
Click [Menu] - [Settings] - [Machine] - [Blocked hole], the interface shown in the figure below:
Fig. 3-9-3
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3.10 Software settings

3.10.1 Date format settings
Click [Menu] - [Settings] - [Software] - [Date format], as shown in the figure below:
Fig. 3-10-1
The date display format includes the following three types:
yyyy-MM-dd, dd-MM-yyyy and MM-dd-yyyy; select common date format; after that, click [Save]; when "Saved
successfully" is prompted, click [OK].
When the time is modified, it is synchronized directly without saving.
The changed date format will be displayed at all the time display positions (such as sending time and
sampling time).
3.10.2 Print settings
Click [Menu] - [Settings] - [Software] - [Print] to choose the print mode, automatic print or not, printer, print
template, whether to print pictures or not, print format, print title settings, as shown in the figure below:
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Fig. 3-10-2
(1)Print mode: select whether to print using the built-in printer or an external printer.
(2)Auto print: select "Yes" or "No" to decide whether to automatically print the report when the test results are
returned.
(3)Printer: select the connected external printer model from the pull-down menu.
(4)Print template: select the print template"Horizontal version" or "Vertical version" from the pull-down menu;
(5)Print pictures: select "Yes" or "No" from the pull-down menu to decide whether to print the histogram.
(6)Print format: select a piece of appropriate paper from the pull-down menu.
(7)Title: edit the header on the print report sheet.
3.10.3 Network settings
Click [Menu]- [Settings]-[Software]-[Network] to set the LIS IP, port, equipment IP and subnet mask. The
interface is as shown:
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Fig. 3-10-3
LIS connection: after the network is set, connect the LIS server.
3.10.4 Language settings
Click [Menu] - [Settings] - [Software] - [Language], as shown in the figure below:
Fig. 3-10-4
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After selecting the corresponding language category and clicking [Save], the message "Saved successfully and the
instrument will restart" will pop up on the screen. After clicking [OK], the software will restart and the language
will be switched successfully.
When the instrument has an alarm, switching languages is not allowed.

3.10.5 Other settings
Click [Menu] - [Settings] - [Software] - [Other], as shown in Fig. 3-10-5:
Fig. 3-10-5
Start sample number: the initial sample number to test each time after start.
Abnormal value icon setting: Users can select high and low value marks including the use of "H, L" and "↑, ↓".
After clicking [Save], when the message "Saved successfully" is prompted, click [OK].
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Chapter 4 Calibration
4.1 General
The instrument is calibrated to ensure the accuracy of analysis result. The instrument must be calibrated before the
measured data can be used as valid data.
4.2 Calibration frequency

The instrument has been calibrated before the delivery. In the following three cases, the operator still needs to
calibrate the instrument:
(1)Before the instrument is used for the first time.
(2)After main parts are replaced.
(3)Obvious deviation is found in the system when QC is operated.
If the calibration fails, check whether the input parameters, calibrator used and reagents are correct, or
operate according to the alarm message and relevant prompts.
4.3 Calibration method

The instrument has three calibration modes: manual calibration, calibrator calibration and fresh blood calibration.
In calibrator calibration and fresh blood calibration, all calibration-related math calculations are performed
automatically by the instrument. The calibration coefficient obtained after the calibration is saved on the "Manual"
interface.
Preparation before calibration: check according to the following steps before the calibration. In case of any
problem, do not perform calibration. Contact the After-sales Service Department of the Company.
(1)Check the instrument and reagent to ensure that the reagent volume is sufficient to complete the whole
calibration process. If the reagent is used up during the calibration, re-calibration is required.
(2)The calibrator and reagent designated by the manufacturer shall be used in accordance with the user manual for
calibrators and reagents.
4.4 Calibrator calibration

Click [Menu] - [Calibration] - [Calibrator], as shown in the figure below:
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Fig. 4-4-1
4.4.1 Input of calibrator reference value

Click the "Reference value" under each item, directly input the reference value of each parameter (refer to the user
manual for calibrators for details).
4.4.2 Calibration counting
(1)Put the test tube with mixed calibrate below the aspiration probe to ensure the sample probe can aspirate the
sample.
(2)Press "Count" on the instrument to start calibration test. Then interface will be locked and the user cannot go to
other operating interfaces. The test status of current calibration will be displayed in the status column at the
bottom.
(3)After the test is completed, the interface is unlocked and the result is displayed in the test result list. The current
record in the selected column is selected by default "√".
If a certain parameter in the obtained count results exceeds the valid range, the prompt will be popped up as
shown in the figure below:
Fig. 4-4-2
The current calibration count results are not saved and the current record in the selected column is not selected by
default. Count the calibration again to overwrite the result.
(4)When the calibration is not completed (the effective calibration count does not reach 5 times), the software will
prompt the user to switch to the other interface as shown below:
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Fig. 4-4-3
When the effective calibration count reaches 5 times, the instrument will automatically calculate the average
Mean, CV%, and the new calibration coefficient for all the calibration data selected by default "√" according to
the formula.
Operators can select some groups of data to calculate the calibration coefficients, but the calibration coefficients
can only be calculated after selecting at least 5 groups of data. Each time the operator click the check box "√" to
select or cancel the "√" data, the calibration coefficient is refreshed and displayed in time.
Calibrate calibration is only performed in the whole blood mode.

4.4.3 Save calibration coefficient
Click [Save] in Fig. 4-4-1. The followings may occur:
(1)When the effective calibration count does not reach 5 times, the prompt is as shown in the figure below:
Fig. 4-4-4
(2)When the CV% value of a calibration parameter exceeds the repeatability index of the instrument, the prompt
is as shown in the figure below:
Fig. 4-4-5
(3)When the new calibration coefficient of a certain parameter is not between 75% and 125%, the prompt is as
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Fig. 4-4-6
In cases 2 and 3, the operator needs to check whether the input reference value is correct and start calibration
counting again.
(4)If the calculated calibration coefficients are all between 75% and 125%, and the CV% values of all the
calibration parameters do not exceed the repeatability index of the instrument, the prompts are as shown in the
figure below:
Fig. 4-4-7
Click [OK], and the calibration coefficient will be automatically saved as the calibration coefficient on "Manual"
interface, as shown in the figure below.
Fig. 4-4-8
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4.5 Fresh blood calibration

4.5.1 Preparation of fresh blood
(1)Use EDTA- K2 (1.5mg/mL ~ 2.2mg/mL blood) anticoagulant vacuum tube to collect venous blood sample.
(2)Quickly and fully mix the venous blood and anticoagulant in the tube.
(3)Prepare 3 ~ 5 portions of normal fresh blood according to the above method.
(4)Take fresh blood samples of normal people, and complete the test within 2 hours so as not to affect the test
results for too long.
4.5.2 Calibration counting
Click [Menu] - [Calibration] - [Fresh blood] as shown in the figure below:
Fig. 4-5-1
(1)Select the analysis mode for whole blood or pre-dilution.
(2)Select the number at the "Sample ID" before each test of fresh blood samples.
(3)Put the test tube with fresh blood samples below the aspiration probe to ensure the sample probe can aspirate
the sample.
(4)Press "Count" on the instrument to start calibration test. Then interface will be locked and the user cannot go to
other operating interfaces. The test status of current calibration will be displayed in the status column at the
bottom.
(5)After the test is completed, the interface is unlocked and the result is displayed in the test result list. The current
record in the selected column is selected by default "√".
If a certain parameter in the obtained count results exceeds the valid range, the prompt will be popped up as
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Fig. 4-5-2
The current calibration count results are not saved and the current record in the selected column is not selected by
default. Count the calibration again to overwrite the result.
(6)When the effective calibration count of each portion of fresh blood reaches 5 times, the instrument will
automatically calculate the average Mean, CV%, and the new calibration coefficient for all the calibration data
selected by default "√" according to the formula. Operators can select some groups of data to calculate the
calibration coefficients, but the calibration coefficients can only be calculated after selecting at least 5 groups of
data. Each time the operator click the check box "√" to select or cancel the "√" data, the calibration coefficient is
refreshed and displayed in time.
(7)If the calibration coefficients calculated of the current number of fresh blood samples are between 75% and
125%, and the CV% values of all calibration parameters do not exceed the repeatability index of the instrument.
Select the "Sample number" again and test the remaining fresh blood samples.
4.5.3 Save calibration coefficient
After the instrument has tested 3 or more fresh blood samples and obtained valid calibration coefficients, click
[Calculate Coefficient] to display the content as shown in the figure below:
Fig. 4-5-3
When less than 3 portions are selected, the average calibration coefficient will not be calculated. When 3 or more
portions are selected, the average calibration coefficient will be automatically calculated. Click [Save] to save the
current calibration coefficient.
When there are less than 3 portions of fresh blood for test, click [Calculate Coefficient] and a prompt as shown in
Fig. 4-5-4 will appear:
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Fig. 4-5-4
After selecting the calibration coefficient of more than 3 fresh blood samples, click [Save] to pop up the dialog
box as shown in the figure below:
Fig. 4-5-5
Click [OK], and the calibration coefficient will be automatically saved as the calibration coefficient on "Manual"
interface.
4.6 Manual calibration

After calibrator calibration or fresh blood calibration is executed and correctly saved and the obtained calibration
coefficient is saved on "Manual" interface.
Click [Menu] - [Calibration] - [Manual], as shown in the figure below:
Fig. 4-6-1
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When fine adjustment of calibration coefficient is required, click corresponding row of each item under
[Calibration coefficient], directly input the calibration coefficient and click [Save]. When a dialog box of "Saved
successfully" pops up on the screen, click [OK].
4.7 Calibration history

The instrument records each piece of calibration information for the user to view.
Click [Calibration history] to display the content below:
Fig. 4-7-1
The calibration date, calibration person, calibration method and calibration mode are displayed in the order of a
list in the calibration history.
Query: the operator can also screen calibration history according to the calibration method.
Click to flip up and down.
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Chapter 5 Quality control
5.1 General
There may be a certain degree of error in the long-term use of the instrument, and the existence of error is likely to
lead to incorrect or unreliable analysis results. The quality control program provides an effective method of
detecting possible errors, and the quality control test allows the operator to test the accuracy and precision of daily
sample analysis results.
To ensure the reliability of the sample analysis results, it is suggested that the operators conduct quality control on
each instrument once with QC materials at low, middle and high levels respectively.
The QC rules can be set through the System settings - QC settings function. For details, refer to sections 3.6.2,
3.6.3, and 3.6.4. When the QC data is out of control, please confirm whether or not the QC object is evenly mixed,
invalid, out-of-date and whether the reagent is contaminated and expires. If none of these happens but the QC test
still fails, please contact the after-sales service personnel.
The instrument must be properly calibrated to perform a quality control test.
The instrument provides four quality control methods, i.e. L-J QC, Xbar QC, X-B floating mean method QC and
Xbar-R QC.
● The user must use the QC materials specified by the manufacturer, otherwise it will lead to inaccurate
QC results.
● The use of QC materials is detailed in its instructions.
● If a quality control test is conducted in the event of an instrument failure, the results obtained are
unreliable.
● If QC is out of control, check if the input parameters, QC products used and reagents are correct, or
operate according to the alarm message and relevant prompts.
5.2 L-J QC
The operator can conduct QC for 20 parameters under L-J QC. The instrument provides 12 QC files in total to
save QC parameters and results. Each QC file can automatically save up to 31 groups of QC results. When QC is
conducted for more than 31 times, the new QC results will overwrite the previous results.
Click [Menu] - [Q.C.] - [L-J], as shown in the figure below:
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Fig. 5-2-1
5.2.1 Settings
5.2.1.1 Lot number information settings
Click [Setting] in QC interface to enter the interface of basic QC settings as shown in the figure below:
Fig. 5-2-2
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(1)Selection of file No.:

Click the file number pull-down menu and select file to be conducted with QC whose range is 1~12.
(2)Input of QC lot No.:
Click the lot number input box and input the lot number of corresponding QC product according to the User
Manual of QC blood.
(3)Life settings:
Click the Life input box, and input the life of QC product according to the User Manual of QC.
(4)Selection of QC level:
Click the pull-down menu and select QC level (including high, medium and low levels), and every QC lot number
corresponds to one level.
(5)Input of target value and deviation limit:
Input the corresponding target value and deviation limit according to QC manual.
After finishing all inputs above, click [Save] to pop up the "Saved successfully" information, and click [OK].
Lot number and life input shall conform to those noted in the user manual.
5.2.1.2 Take the preset value
Click [Use DEF] to input the reference value and deviation limit at corresponding level saved in the system into
current QC file.
If the reference value and deviation limit at corresponding level are not saved in the system, click [Use DEF] and
then a prompt dialog box will pop up as shown in the figure below:
Fig. 5-2-3
After taking the preset value, click [Save] to pop up the "Saved successfully" information, and click [OK].
5.2.2 QC counting
Click "QC count" in Fig. 5-2-4 to enter QC counting interface, and the display will be as shown below:
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Fig. 5-2-4
(1)Put the test tube with evenly mixed QC substances below the aspiration probe to ensure the aspiration probe
can aspirate the sample.
(2)Press the "Count" key for the aspiration probe to aspirate the QC object automatically. After the probe is raised
up, remove the tube. Add the QC object in the probe into the counting cell. Meanwhile, display the QC test status
successively in the operating status column at the bottom of the interface.
(3)After the analysis, the aspiration probe will reset and get prepared for next counting and the counting results
will be displayed on the screen, as shown in the figure below:
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Fig. 5-2-5
QC data print:
Click [Print] to print current record in the shortcut key area if a single QC result needs to be printed.
5.2.3 QC diagram
Click [QC diagram] in Fig. 5-2-5 to enter the diagram viewing interface and the display will be as shown below:
Fig. 5-2-6
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(1)QC diagram query: select to view item data.

(2)Description of QC diagram interface:
If the number of QC counting is less than 3, QC result of each parameter will not be displayed on the right of QC
diagram.
No target value or deviation limit is set. The QC chart does not show the QC results.
The X-axis of QC diagram shows the number of QC counting result in QC file, while the Y-axis shows QC
counting result of each parameter.
Vertical bar is used to mark the count data of the same group, and at most 31 points can be displayed in the QC
diagram for every parameter.
As for each parameter, these three data on the left of the QC diagram correspond to three boundary values,
representing respectively, from top to bottom, the upper limit, target value and lower limit of the parameter:
Upper limit: QC material reference value + deviation limit
Target value: reference value of QC material
Lower limit: QC material reference value - deviation limit
As for each parameter, the three data on the left of QC diagram respectively represent Mean (mean), SD (standard
deviation) and CV% (coefficient of variation).
(3)Description of points in QC diagram:
Each point in QC diagram corresponds to a QC result and the points are connected by line sections.
"Green solid circle" refers that the QC result is under control, while "Red hollow circle" refers that the QC result
is out of control.
(4)If points in the QC diagram is beyond the QC range, deal with them in accordance with the steps below:
a)Check whether the target value and deviation limit of QC material are correct.
b)Whether the background test of the instrument is normal.
c)If the above two points are all normal, calibrate the instrument and then perform QC and count.
d)If the instrument remains abnormal after calibration, please contact the after-sales service department of
manufacturer.
(5)Print QC diagram:
Click [Print] to print according to the preset template of QC diagram.
Correctly connect the printer, and click [Print] in the figure above to print the report needed.
(6)Calculate preset value in QC diagram:
When 3 or more QC results exist in QC diagram, calculate and save preset values following the procedures below:
Operator can calculate Mean (mean), SD (standard deviation) and CV% (coefficient of variation) in QC diagram
which serve as preset values in QC editing.
(7)Deviation limit settings:
For details, refer to section 3.6 "QC settings".
(8)Remove the abnormal QC point:
If abnormal QC point exists in QC diagram, remove it and then take preset value following the operation
procedures below:
Click [Calculate DEF] in the Fig. 5-2-6, as shown in the figure below:
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Fig. 5-2-7
Click on the selected abnormal QC point to let the red cursor line stay on the point. Click [Delete] for the selected
abnormal QC point to become "black point"; when the preset value is taken for calculation, it does not include the
removed QC point (black QC point).
After removing the invalid point, click [Save DEF] for the instrument to calculate the preset value in the current
level and save it in the system. The "add" and "delete" keys will disappear.
If there are less than 3 valid QC points, click [Save DEF] to pop up the prompt box as shown in the figure below:
Fig. 5-2-8
If the operation above has error, click the screen to move the red cursor line to the removed point, and black QC
point will turn to be red or green through clicking [Add], then the removed point will recover to normal.
When calculating the preset value, adopt data of valid QC point as reference value and deviation limit.
5.2.4 QC list
User can select different QC file to view QC data.
Click [QC list] and select QC file No. to be queried from the pull-down menu of [File No.], as shown in the figure
below:
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Fig. 5-2-9
(1)Delete all: operator can delete all QC counting results in current QC file.
Click [Delete All] to pop up the prompt box as shown below:
Fig. 5-2-10
Click [OK] to delete all the data.
(2)Delete: operator can delete a QC counting result in current QC file.
Select the QC data to be deleted and click [Delete] to pop up the prompt box as shown in the figure below:
Fig. 5-2-11
Click [OK] to delete the selected data.
(3)LIS transmission: when connecting LIS, operators can transmit the QC results in current QC file to the LIS
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software.
(4)View data: select to view item data through page up and down;
to view item data through page left and right.
5.3 Xbar QC
Xbar QC: adopt the mean of two measurement result as a QC point to be saved in QC diagram.
Other operations are the same as "5.1 L-J QC".
5.4 X-B QC
X-B floating mean method is put forward by Dr. BrianBull, through which monitoring and control of instrument
performance can be achieved through monitoring the stability of red blood cell parameters such as MCV, MCH
and MCHC. It belongs to QC without QC material, which is a monitoring and control method of instrument
performance like QC though QC material, and as these two methods can respectively reflect the analysis
performance of the instrument from different sides, they cannot replace each other. X-B QC is recommended
when the daily sample volume of the instrument is larger than 100. Accompanying sample is required to be used
in the QC method which, as a result, cannot be used for sample classified according to disease types. Its reference
range is composed of given reference value and upper and lower limit. Observe the change trend of QC result
within the reference range.
The instrument conducts X-B QC to three parameters: MCV, MCH and MCHC, and 20-200 samples can be tested
in X-B value analysis for each group which come from the result of normal counting without distinguishing
whole-blood from pre-dilution mode.
As the X-B QC reference value is worked out after statistics and analysis of a large amount of accompanying
samples, the instrument shall be calibrated before test.
5.4.1 Settings
Before X-B QC, QC parameter shall be set.
Click [Menu] - [Q.C.] - [X-B], as shown in the figure below:
Fig. 5-4-1
Input target value and deviation limit: click the table of corresponding target value and deviation limit of
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parameters to input.
Target value: as the reference value differs from region to region, sample quantity is required to reach a certain
number (more than 150 is recommended), then the arithmetic mean value of these samples is selected as the target
value of X-B QC.
Deviation limit: 3%~5% of target value shall be used as corresponding deviation limit.
Target value and deviation limit shall not be null.

After settings are complete, click [Save] to pop up the "Saved successfully" information, and click [OK].
5.4.2 QC diagram
Click [QC diagram] to enter the X-B QC chart interface, as shown in the figure below:
Fig. 5-4-2
(1)Description of QC diagram:
As for every parameter, the three data on the left of the QC diagram correspond to three boundaries, representing
respectively, from top to bottom, the upper limit, target value and lower limit of the parameter.
Upper limit: QC material reference value + deviation limit
Target value: reference value of QC material
Lower limit: QC material reference value - deviation limit
"Green solid circle" refers that the QC result is under control, while "Red hollow circle" refers that the QC result
is out of control.
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(3)If points in the QC diagram are out of the QC range, dispose following the procedures below:
Check whether the target value and deviation limit are correct.
Whether the background test of the instrument is normal.
If the instrument remains abnormal after calibration, please contact the after-sales service department of
manufacturer.
5.4.3 QC list
Click [QC list] to enter the X-B QC list to review the interface, as shown in the figure below:
Fig. 5-4-3
(1)Delete: click QC data following the corresponding number to display the selection status in the row, and click
[Delete], as shown in the figure below:
Fig. 5-4-4
Click [OK] and the prompt information "Deleted successfully" will pop up on the interface which means that
selected records are successfully deleted.
Target value and deviation limit shall not be deleted.

(2)Delete all: click [Delete all] as shown in Fig. 5-4-5:
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Fig. 5-4-5
Click [OK] to delete all the records.
(3)Check the data: select , check the item data through page turning.
(4)LIS transmission: click [Transmit LIS] to transfer the data to the LIS system connected with.
5.5 XBAR-R QC
Xbar QC diagram is mainly used to observe the change of normal distribution means, and R QC diagram is used
to observe the change of dispersion or variation of normal distribution while Xbar-R QC diagram integrated with
the two diagrams above is used to observe the change of normal distribution.
Xbar-R QC diagram reflects the difference between lots and between days of everyday test, achieving the
effective monitoring of system factors during test, thus it suits laboratory with high level automation and large
inspection amount.
Xbar-R QC: adopt the mean of two measurement results as a QC point saved in mean QC diagram; adopt
difference between two measurement results as a QC point saved in range QC diagram. Every parameter is
displayed in mean QC diagram and range QC diagram.
Fig. 5-5-1
5.5.1 Settings
Click [Setting] in the QC interface to enter the interface of basic QC settings as shown in the figure below:
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Fig. 5-5-2
(1)Selection of file No.:
Select the QC files numbering 1~12 in the "File No.".
(2)Input of QC lot No.:
Click "Lot number" input box and input the lot number of corresponding QC product according to the User
Manual of QC blood.
(3)Life settings:
Click "Life" input box, and input the life of QC product according to the User Manual of QC.
(4)Selection of QC level:
Select the QC level (including high, medium and low levels) in the "Grade" pull-down menu. Each QC lot number
corresponds to one level.
After settings are complete, click [Save] to pop up the "Saved successfully" information, and click [OK].
Lot number and life input shall conform to those noted in User Manual
5.5.2 QC counting
Click [QC count] to enter the QC counting interface, as shown in the figure below:
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Fig. 5-5-3
(1)Put the test tube with evenly mixed QC substances below the aspiration probe to ensure the aspiration probe
can aspirate the sample.
(2)Press the "Count" key for the aspiration probe to aspirate the QC object automatically. After the aspiration
probe is raised up, the operator can move away the test tube and empty the QC object in the need into the count
cell. Meanwhile, display the QC test status successively in the operating status column at the bottom of the
interface.
Only when the result is 1, it is forbidden to switch the interface. If it is switched, the test result of result 1
will not be saved.
(3)After the analysis, the sample probe will reset and get prepared for next counting and the counting results will
be displayed on the screen, as shown in the figure below:
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Fig. 5-5-4
If the counting result worked out is lower than the lower limit set in the instrument software, it will be displayed
in blue, and if higher than the display range of the instrument, it will be displayed in red.
(4)QC data modification
The administrator's user rights can modify the test data.
After QC test, if results need to be modified, click the result to modify, then click [Save] to save the modified
results.
5.5.3 QC diagram
Click [QC diagram] to enter the graph view interface, as shown in the figure below:
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Fig. 5-5-5
(1)Relevant calculation description:
a)Mean:
a bcdef gh i j
Xbar 
n
Wherein:
a~j refer to the mean of every two measurement results;
n refers to the number of mean.
b)Range mean:
Ra  Rb  Rc  Rd  Re  Rf  Rg  Rh  Ri  Rj
Rbar 
n
Wherein:
Ra~Rj refer to the range of every two measurement results;
n refers to the number of range.
(2)Description of QC diagram interface:
If the number of QC counting is less than 3, QC result of each parameter will not be displayed on the right of QC
diagram.
Vertical bar is used to mark the count data of the same group, and at most 31 points can be displayed in the QC
diagram for every parameter.
As for each parameter, these three data on the left of the QC diagram correspond to three boundary values,
representing respectively, from top to bottom, the upper limit, target value and lower limit of the parameter.
QC diagram of every test item includes mean QC diagram and range QC diagram, take WBC for example, and the
display will be as shown below:
a)Mean diagram (WBC M part is displayed in the figure):
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Target value of mean: CL  Xbar

Upper limit of mean: UCL  Xbar  1.88  Rbar (1.88 in the formula is fixed value)
Lower limit of mean: LCL  Xbar  1.88  Rbar (1.88 in the formula is fixed value)
b)Range diagram (WBC R part is displayed in the figure):
Target value of range: CL  Rbar
Upper limit of range: UCL  3.27  Rbar (3.27 in the formula is fixed value)
Lower limit of range: LCL  0
"Green point" refers to the QC result is under control while "Red point" refers to the QC result is out of control.
(4)If points in the QC diagram are beyond the QC range, deal with them in accordance with the steps below:
a)Whether the background test of the instrument is normal.
b)If the background test is normal, re-execute QC counting, and if abnormal QC point remains in QC diagram,
conduct QC counting after the calibration of instrument.
c)If the instrument remains abnormal after calibration, please contact the after-sales service department of
manufacturer.
5.5.4 QC list
User can select different QC file to view QC data.
Click [QC list] and select the QC file No. to be queried from the [File No.] pull-down menu, as shown in the
figure below:
Fig. 5-5-6
(1)Delete all: operator can delete all QC counting results in current QC file. Click [Delete all] in the figure above,
as shown below:
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Fig. 5-5-7
Click [OK] to delete all the data.
(2)Delete: operator can delete a QC counting result in current QC file.
Select the QC data to be deleted and click [Delete], as shown in the figure below:
Fig. 5-5-8
Click [OK] to delete the selected data.
(3)LIS transmission: operators can transmit the selected QC counting results to the LIS system.
(4)Print: operator can print QC counting result in current QC file.
(5)Check the data:
Select to turn up and down to check the item data;
Select to turn left and right to check the item data.
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Chapter 6 Sample registration
6.1 General
The operator can enter the information of the samples to be analyzed before sample analysis, click on the worklist
in the mode settings and test the samples to be analyzed in order.
Click [Menu] - [Sample registration], as shown in the figure below:
Fig. 6-1-1
6.2 Edit info.

Click [Add] in Fig. 6-1-1 to add a sample to be tested. Select the sample to be tested and click [Edit information],
and the interface is shown in Fig. 6-2-1.
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Fig. 6-2-1
6.2.1 Sample information

(1)Sample ID.: Edit the sample number to be tested.
(2)Bar code: The default is null and it can be input manually or by scanning.
(3)Analysis mode: The newly added record defaults to the mode currently used by the instrument and cannot be
modified.
(4)Case No.: Input the patient case number manually;
(5)Sending doctor: Select the doctor in the pull-down menu.
(6)Sampling and Sending: The newly added record defaults to the current time, which can be directly changed.
When changing it, note that the sampling time cannot be greater than the sending time, and neither can it exceed
the current system time.
6.2.2 Patient information
(1)Name: Input the name of the patient directly.
(2)Sex: The sex of patient includes male, female and ?. Click the pull-down menu beside "Sex" to select one.
(3)Reference group: The reference ranges for test items include general, adult male, adult female, child, newborn
and five custom reference ranges, totally 10 ranges for selection. Click the "Reference group" pull-down menu to
select one.
(4)Age: Click the pull-down menu beside "Age unit" to pop up the picture shown below.
Fig. 6-2-2
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The reference group is linked with age and sex. After the sex is selected, age is input and age unit is selected, the
reference group will be selected automatically. For the newborn, it is smaller than or equal to 28 days. For
children, it is greater than 28 days but no greater than 13 years. For the general, it is greater than 13 years. If it is
greater than 13 years and the sex is male, it will be deemed adult male by default. If it is greater than 13 years and
the sex is female, it will be deemed adult female by default.
(5)Department: Click the pull-down menu beside "Department".
(6)Cost type: Select the cost type from the pull-down menu.
(7)Remark: user can input detected clinical diagnosis information (can be input directly).
After all the above said information is input, click [Save] to save them.
6.3 Download worklist

Click [Download] in Fig. 6-1-1 to enter the interface as shown in the figure:
Fig. 6-3-1
Manually enter or scan the input sample bar code number, click [OK]. After the download is successful, the
patient information is entered in the worklist. After the "Data returned successfully" is displayed below the bar
code number, the worklist can continue to be downloaded. The following abnormal situations may occur during
download:
(1)When the bar code number is not input, the prompt box as shown in the figure below will pop up:
Fig. 6-3-2
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(2)When the LIS is not connected, the prompt box as shown in the figure below will pop up:
Fig. 6-3-3
(3)When there are 200 worklists in the instrument, the prompt box as shown in the figure below will pop up:
Fig. 6-3-4
(4)When the bar code information and the LIS terminal do not match, the content shown in the figure below will
display:
Fig. 6-3-5
After the worklist is downloaded, click [Cancel] to exit the interface.
6.4 Delete worklist

(1)Delete all: The operator can delete all QC counting results in the current QC file. Click [Delete all] in Fig.
6-3-1:
Fig. 6-4-1
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(2)Delete: the operator can delete a QC counting result in current QC file.

In Fig. 6-3-1, select the worklist to be deleted and click [Delete]:
Fig. 6-4-2
Click [OK] to delete the selected worklist.
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Chapter 7 Routine operation
7.1 General
This chapter introduces the whole regular operation process from startup to shutdown of the instrument, which
gives specific instructions on the operation process of the whole-blood sample analysis and pre-dilution
(peripheral blood) sample analysis.
The daily operation process is shown as follows:
Fig. 7-1-1
7.2 Preparations for operation

Before turning on the power switch of the instrument, the operator shall conduct an inspection in accordance with
the following requirements to ensure the instrument prepared to work.
(1)Inspection of waste liquid tank
Ensure the waste liquid tank empty before startup every day.
(2)Liquid path inspection
Check if the pipeline connected with the reagent and waste liquid tank is bent or twisted, and if the connection is
reliable.
Please use matching reagent produced by Dirui Company. The Company will not be responsible for
inaccurate test results caused by failure to use matching reagent.
(3)Inspection of power source
Check if the power cable of the instrument is connected correctly.
(4)Inspection of printer
Check if the data cable of the printer is correctly connected to the instrument, and if the power cable is connected
correctly.
Check whether the printing paper is sufficient and the installation is correct.
(5)Inspection of bar code reader
Check if the cable of the external bar code reader is correctly connected to the instrument.
7.3 Turn on
Turn on the power switch. The screen displays "System Loading... " and the instrument is initialized.
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7.4 Daily QC
Before the sample analysis, a QC analysis of the instrument shall be conducted every day to ensure reliable
analysis results of the instrument. For details, see Chapter 5 Quality Control.
7.5 Sample preparation

7.5.1 Whole-blood sample
(1)Use a clean EDTA-K2 (1.5mg/mL~2.2mg/mL of blood) anticoagulation vacuum tube to collect venous-blood
sample, and ensure the collected sample volume over 1mL.
(2)Quickly and fully mix the venous blood and anticoagulant in the tube.
● The operator shall use clean EDTA-K2 anticoagulation vacuum tubes, silicified glass/plastic test tubes
and 20μL of silicon-boronized glass capillaries.
● Samples used for white blood cell classification or platelet count shall be saved under room temperature,
and shall be analyzed within 8 hours after collection.
● If the analysis results of PLT, MCV or three classification of white blood cells are not needed, the samples
can be saved in 2℃~8℃ of refrigerator for 24 hours. The refrigerated samples shall be placed under room
temperature for at least 30 minutes before analysis.
● Samples having been placed for a certain time shall be re-mixed before analyzing.
7.5.2 Peripheral blood sample
(1)Click "Dispense diluent" in the shortcut key area to pop up the prompt of "Prepare to dispense diluent", as
Fig. 7-5-1
(2)Click [OK] and it will prompt "Preparing diluent" on the interface.
(3)Take a clean centrifugal tube and put it below the aspiration probe at the angle indicated in the figure, press the
Count key (the interface will show the diluent dispensing amount and times), ensuring that the diluent flows to the
centrifugal tube along tube wall and prevent bubbles or spill:
Fig. 7-5-2
(4)Collect 20μL of peripheral blood and quickly dispense it along the centrifuge tube wall into the tube filled with
diluent, and then mix them.
Prepare several pre-diluted samples continuously and repeat (3) and (4). At most five pre-diluted samples can be
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prepared continuously. After pre-dilution of the five samples, the instrument will prompt to exit. The operator can
dispense the diluent again after exit.
(5)Click [Complete] on the interface and it will prompt "Stopping..." After that, it will return to the interface
shown in the figure above.
Fig. 7-5-3
● Operators can also use a pipettor to aspirate 700μL diluent to a centrifugal tube, and then dispense the
collected 20μL peripheral blood along the centrifuge tube wall into the tube, and then mix them.
● Avoid dust mixing into the prepared diluent, or it will cause analysis error.
● Fully mixed peripheral blood and diluent shall be placed for 3 minutes, and then be re-mixed for
analyzing.
● Ensure the diluted sample be analyzed within 30 minutes, or it will cause unreliable analysis results.
● Samples having been placed for a certain time shall be re-mixed before analyzing.
● Each laboratory shall conduct a stability assessment of the sample analysis result under pre-dilution
mode in accordance with the specific sample quantity, sampling method and technological level of each lab.
7.6 Whole-blood sample analysis

Under the main interface, if the current mode is "Whole blood", conduct the test directly. Or set the current mode
as "Whole blood" according to the following operation.
● Set the reference value range of the parameters on the "Settings" interface before the test, or there may
be an alarm prompt of incorrect result after the test.
● Conduct the sample analysis directly after selecting work mode, and the defaulted reference range of the
instrument is "Ordinary". After the analysis, the alarm of the instrument is given in accordance with the
reference value range of "Ordinary" settings.
(1)Click [Mode] on the sample analysis interface, and the dialog box will pop up as shown below:
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Fig. 7-6-1
Modification of analysis mode and sample number:
a)Under the [Analysis mode], select the "Whole blood" or "Micro-whole blood" mode.
b)In the next sample number edit box, the number of the next sample can be modified.
c)Click [Save] to save the settings.
The upper limit of the input sample number is 12 bits, and "–" is valid, but "." is invalid.
(2)If the blood-collecting tube is 2mL, select "Whole blood" under analysis mode; if the blood-collecting tube is
0.5mL, select "Micro-whole blood" under analysis mode. After a correct selection, click [Save], and the operation
mode will automatically switch to the "Whole blood" mode.
(3)Under the prepared count status, slightly shake the sample tube in up-down direction to make the sample fully
mixed, and place it below the aspiration probe, and then press "Count button" on the front panel of the instrument
to conduct the test. After the test, the software will automatically save the analysis results and the test results will
be displayed on the screen. After the sample is aspirated, the probe will return to the initial position to wait for the
next test.
(4)Click [Print] on the sample analysis page to print the current report.
● Browsing of the graphs and viewing of the research parameters can be conducted in the analysis process,
but no operation can be performed; the data will be automatically saved in the sample analysis after
analyzing.
● During analysis, if the aperture is plugged or behind the test data there is a "?", the analysis results are
not reliable. Please conduct "Unblocking" and continue the test.
● If the room temperature exceeds the normal working temperature range of the instrument, analysis
results will not be reliable.
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7.7 Analysis of pre-dilution samples
● If it is in the "whole blood" mode at present, select the "Mode" button in the lower right corner of the
main interface to enter the mode of page switching to change to the "Pre-dilution" mode.
● Set the reference value range of the parameters on the "Settings" interface before the test, or there may
be an alarm prompt of incorrect result after the test.
● Conduct the sample analysis directly after selecting work mode, and the defaulted reference range of the
instrument is "Ordinary". After the analysis, the alarm of the instrument is given in accordance with the
reference value range of "Ordinary" settings.
(1)On the sample analysis interface, click [Mode] to enter the mode setting interface as shown in Fig. 6-5-1:
Fig. 7-7-1
Modification of analysis mode and sample number:
The same as modification of analysis mode and sample number in 7.6.
(2)After correct selection, click [Save] to make the operation mode automatically switch to the "Pre-dilution"
mode.
(3)Press the "Count" key for the aspiration probe to aspirate the sample automatically. After the aspiration probe is
raised up, the operator can move away the test tube and empty the sample in the need into the count cell. The
instrument executes counting and displays "Counting..." at the lower part of the screen.
(4)After the analysis, the aspiration probe will reset and get prepared for next counting and the counting results
will be displayed on the screen.
(5)If the automatic printing is set as Yes, the instrument will print records according to the set mode automatically.
If the automatic transmission is set as Yes, the instrument will transmit the analysis results to external computer
automatically.
(6)Analyze other samples according to the steps above.
(7)Click [Print] on the sample analysis page to print the current report sheet.
● Browsing of the graphs and viewing of the research parameters can be conducted in the analysis process,
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but no operation can be performed; the data will be automatically saved in the sample analysis after
analyzing.
● If the room temperature exceeds the normal working temperature range of the instrument, analysis
results will not be reliable.
7.8 Parameter alarm

7.8.1 Parameter alarm type
Parameter alarm comprises the following three types:
(1)When there are prompts of "↑, ↓" or "H", "L" in the counting results, it indicates that the counting results
exceed the pre-set reference value range.
(2)When the counting results display as "*.**", it indicates that the test results are invalid or exceed the display
range.
(3)When the counting results include hole blockage, "?" will be displayed behind the hole blockage results.
7.8.2 Abnormal alarm for classification or morphology
The instrument can give abnormal alarms for WBC, RBC/HGB and PLT according to histograms, and the prompt
information is as shown below:
RBC/PLT alarm
Unequal RBC volume RDW-SD > 65.0 fL or RDW-CV > 20.0 %
Small cellular red blood cells MCV < 70.00 fL
Large cellular red blood cells MCV > 110.0 fL
Hypochromia MCHC < 290.00 g/L
Anemia HGB < 100.00 g/L
Polycythemia RBC > 6.50 1012/L
Thrombocytopenia PLT < 60 109/L
Thrombocytosis PLT > 600 109/L
WBC alarm
Hypoleucocytosis WBC < 2.50 109/L
Leukocytosis WBC > 18.00 109/L
Decrease of cellules LYM# < 0.60 109/L or LYM% < 0.0 %
Increase of cellules LYM# > 4.00 109/L or LYM% > 100.0 %
Decrease of maxicells NEU# < 1.00 109/L or NEU% < 0.0 %
Increase of maxicells NEU# > 11.00 109/L or NEU% > 100.0 %
7.9 Sleep
When the stop time of the instrument meets the automatic sleep time set by the software, it enters hibernation and
displays the instrument sleep status in the status bar. After the instrument enters hibernation, the screen will sleep
at the same time. Click anywhere on the screen to wake up the screen. If you want to continue the instrument
operation, press the counter key and the system will continue to operate after it wakes up.
7.10 Rinsing and unblocking

The instrument will rinse the components where sample flows through automatically in each counting period to
ensure no samples left in the liquid path, and the rinsing parts are as follows:
(1)Internal and external sides of the aspiration probe.
(2)Count cell.
When instrument gives prompt "blocking", execute unblocking operation on [Maint.]→[Service]→[Maintenance]
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interface (equal to executing operation of "Cauterize" and "Back washing" functions).
7.11 Shutdown
In order to ensure stability of instrument and accuracy of analysis results, after a continual working of 24
hours, the operator shall execute shutdown operation according to the following steps.
Click [Menu] - [Shutdown], the following prompt will pop up:
Fig. 7-11-1
Follow the prompt to place the prepared cleanser under the aspiration probe. Click the "count" button on the
instrument to start the instrument shutdown process. In the shutdown process, soak and rinse the liquid path and
the counting cell. After the two actions are complete, the following prompt box will pop up:
Fig. 7-11-2
At this time, the operator can turn off the instrument and set the power switch of the host to "O" to shut down the
instrument.
After shutdown, empty and properly deal with the waste liquid in the waste liquid tank.
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Chapter 8 Results query
8.1 General
The instrument will automatically save the analysis results in the database after executing sample analyzing each
time. The instrument can store up to 500,000 (BCC-3900)/200,000 (BCC-3960) sample analysis results. The
administrator can query all the sample results stored in the database. If sample storage volume is larger than the
maximum, the former sample results will be overlaid automatically.
Select [History] on the main interface to enter into the history query interface as shown below:
Fig. 8-1-1
The results in the sample database are displayed in the form of list by the testing order.
If the current screen does not fully display, press the key at the bottom of the
screen to turn the page.
8.2 Record selection

Click [Select] in Fig. 8-1-1 to look up the sample results in the known position of the sample database:
Fig. 8-2-1
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Enter the selection range and click [OK]. The result of entering the sample number is displayed on the current
screen and is selected.
The sample position number input shall be within the scope of the sample database, otherwise a warning
"the input beyond the maximal scope" will prompt.
To cancel the selected sample, click [Deselect] in Fig. 8-1, then all selected samples will be unselected and the
sample No. at current position will become 0 in the status bar.
8.3 Query
User can inquire data in the sample database by settings different conditions. Click [Query] in the bottom menu
bar in Fig. 8-1-1, and the interface as shown below will pop up:
Fig. 8-3-1
Query conditions: sample number, analysis mode, name, medical record number, department, charge, test time,
unapproved, not printed, and no communication. Query by one of these conditions, or by different combinations.
Moreover, query can be operated by selecting "Unaudited" or "Unprinted".
8.4 Audit and cancel audit

Users can select the sample in the result query. In Fig. 8-1-1, click [Audit] or [Cancel] to change the result status.
8.5 LIS transmission

The operator can manually transmit the selected result to the LIS system.
8.6 Delete
In Fig. 8-1-1, select the record to be deleted, and click [Delete] in the interface, as shown in the figure below:
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Fig. 8-6-1
Click [OK] to delete the selected record.
8.7 Image review

Users can check single record in the graphic form, select a sample in Fig. 8-1-1 and then click [Image review] on
the interface, as shown below:
Fig. 8-7-1
The arrangement of sample database and total number of samples are displayed in the status bar in the form of
"position/total number".
On this interface, users can review and edit information and results and perform histogram adjustment.
8.7.1 Edit information
Click [Edit information] in Fig. 8-7-1, as shown in the figure below:
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Fig. 8-7-2
Edit the sample information in the corresponding text box and then click [Save] to finish editing. The sample
number, analysis mode, and test time are not editable.
8.7.2 Edit result
Click [Edit result] in Fig. 8-7-1:
Fig. 8-7-3
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After directly modifying the result value of the corresponding parameter, click [Save] and return to the interface
shown in Fig. 8-7-1.
After modification of the results, the sample records are shown in italics in the graph review and sample
analysis interfaces.
8.7.3 Histogram adjustment
In Fig. 8-7-1, click [Histogram] to enter into the histogram adjustment window, as shown in the figure below:
Fig. 8-7-4
(1)There are histograms of WBC, RBC and PLT on the right side of histogram adjustment window; and every
parameter value is displayed on the left side as well. The WBC histogram has three vertical lines on the left,
center, and right. The RBC and PLT histograms have two vertical lines on both left and right. The vertical line is
the classification line, and the two vertical line intervals are the value areas. On the left side of the histogram it
shows the names of all the vertical lines displayed in the radio format. Select the name of the vertical line to be
modified. Click and , and adjust the position of the selected vertical line. The left
parameter value will change with the adjustment line. For example, when adjusting the left classification line of
the RBC histogram, both the RBC parameter value and the RBC related parameter value change.
(2)Click "Save" after adjustment to save the results.
(3)Cancel: Return to the sample analysis interface.
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Chapter 9 System maintenance
9.1 General
To guarantee the effective operation and lengthen the service life of the instrument, users shall have routine
maintenance for the instrument according to requirements. Although the instrument will automatically give
prompt to remind users to execute corresponding maintenance after testing a certain amount of samples or
continuously operating for a certain time, and the software system is provided with a special service menu which
will show the measures of routine maintenance or in case of failure, users shall make appropriate maintenance and
servicing plan as per specific laboratory conditions, such as the daily sample volume, operating environment and
operating time of the instrument, to reduce factors that affect analysis accuracy and to guarantee the normal
operation of the instrument.
● Don't spill reagent, sample or waste liquid on the mechanical or electrical parts of the instrument in case
of any damages.
● During operation, operators shall take preventive measures like wearing protective gloves and working
clothes, or they may be infected after touching the polluted area or solution. Please wash with water and
take disinfection measures if touching any polluted liquid.
● During rinsing and maintenance, please check whether parts containing liquid lose efficiency as they may
cause hazards.
● The instrument is installed with a laser. Operators shall check the warning labels during maintenance
and servicing process, but not stare forward the light beam directly or through the optical instrument.
Please wear protective glasses when looking straight at laser source.
● Improper maintenance may cause instrument damage. Operators shall maintain the instrument
according to the user manual.
● If the instrument is installed with accessories which are not provided or recommended by the
manufacturer or the instrument is used otherwise specified by the manufacturer, the relating protection
may be weakened.
● During maintenance process, please check whether there are hazards caused by inefficiency of hoses or
parts filled with solution.
● For the problems without solutions in the User Manual, please contact the after-sales service department
of the manufacturer to obtain suggestions from professional personnel.
9.2 Maintenance Guide

9.2.1 Regular maintenance
(1)Daily maintenance:
Carry out AC before sample analysis every day according to "Chapter 5 Quality Control".
If the instrument is not shut down for 24 hours, execute "Rinse equipment" once every day. Click [Rinse
equipment] on the main menu to execute the rinsing operation of the equipment.
If the instrument is not turned off for 24 hours, execute "WBC cell" and "RBC cell" operation once a day. Click
[Service] on the main menu, and then click [Rinse] to enter rinsing interface and then click [WBC cell] and [RBC
cell] to execute rinsing action. In the rinsing process, other operations shall not be conducted and the rinsing
action shall not be suspended.
(2)Weekly maintenance:
If the instrument is turned off every day, execute "WBC cell" and "RBC cell" soaking operation once a week.
Click [Service] on the main menu, and then click [Maintenance] to enter maintenance menu and then click [WBC
cell] and [RBC cell] in "Soaking" area to execute soaking action. In the soaking process, other operations shall not
be conducted and the soaking action shall not be suspended.
(3)Monthly maintenance:
If the instrument is turned off every day, the swab shall be rinsed every month.
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a)Use a cotton swab dipped with distilled water to wipe the crystal on the tip of the swab.
Fig. 9-2-1
b)Click [Service] on the main menu, and then click [Rinse] to enter rinsing interface and then click [Swab] to
execute rinsing action. In the rinsing process, other operations shall not be conducted and the rinsing action
shall not be suspended.
9.2.2 Timely maintenance
Users can set automatic rinsing interval in "Settings" (settings range: 10~200 times), and the instrument will
automatically execute rinsing after reaching the set test number
When instrument is left unused for over 2 weeks, replace reagent with distilled water, and click
[Menu]→[Maint.]→[Service]→[Maintenance] and [Package rinsing], then interrupt distilled water supply, and
execute [Package emptying], after finishing the two operation above, place the instrument at a clean and dry
position.
When instrument gives prompt "blocking", press [Menu]→[Maint.]→[Service]→[Maintenance] and [Unblocking]
to execute unblocking operation or execute [Cauterize] and [Back washing].
If the instrument is left unused for a long time, after turn-on, select [Menu]→[Maint.]→[Service]→[Fill]
successively to execute the operation of [Diluent] and [Lyse].
When instrument works under a normal working environment and state, the analysis result is reliable.
If other failure prompt is given, please refer to troubleshooting table.
9.3 System maintenance

9.3.1 Basic status with
Click [Menu] - [Maint.] - [Basic status], as shown in the figure below:
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Fig. 9-3-1
(1)Temperature: Display the current ambient temperature and normal temperature range.
(2)Voltage: Display the current erythrocyte small hole voltage, leukocyte small hole voltage, and normal voltage
range.
9.3.2 Pressure
Click [Menu] - [Maint.] - [Pressure], as shown in the figure below:
Fig. 9-3-2
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Pressure: Display the current pressure of the instrument system and the normal pressure range.
9.3.3 System Version
Select [Menu]- [Maint.]-[System version] to view the version of each circuit board. The interface is as shown:
Fig. 9-3-3
Version number in the figure is for reference only, the version number of software will change with the
upgrading of program.
9.3.4 Mechanical detection
Click [Menu] - [Maint.] - [Mechanical test], as shown in the figure below:
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Fig. 9-3-4
(1)Motor:
When some part of the instrument breaks down, the failure can be judged by motor detection. This program sets
the following detection motors: X-axis motor, Y-axis motor, and syringe motor. Click [Detection] after the
corresponding motor and the test result will be displayed on the screen ("Success" or "Failure").
(2)Valve:
If the instrument works abnormally due to valve failure, valve detection can serve as an important method to
eliminate liquid path failure.
Valve status after the test is completed: Yellow indicates successful detection and red indicates failed detection.
The operation process is as follows:
Click the corresponding number of the valve (numbers in Fig. 9-3-4 refer to the valves), and the instrument will
automatically detect the valve. Click the valve number and the sound of opening/closing the valve can be heard,
which suggests that the valve is in a normal state.
Click [Detection] after automatic detection, and the instrument will automatically detect the valves in order.
Meanwhile, the valve opening and closing sounds should be able to hear.
(3)Pump:
Click "Positive pressure" or "Negative pressure" to check whether the pump is under normal status.
After detection, click [Sample analysis] at the upper part of the screen to exit mechanical detection interface and
return to main interface.
Valve detection and positive/negative pressure pump detection cannot be executed at the same time.
9.3.5 Services
The software provides multiple service functions to guarantee the accurate and effective operation.
In the instrument alarm and sleep state, it’s not allowed to perform service operations.
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9.3.5.1 Replace/Fill
Conduct background test after replacing diluent and lyse, and execute sample test when background test result is
within the normal range.
Click [Menu] - [Maint.] - [Service] and select the [Replace]/[ Fill] tab.
(1)When it is necessary to replace some reagent, proceed as follows:
Fig. 9-3-5
a)Replace lyse:
If the lyse tubing has bubbles or the lyse is polluted or the lyse is used up and the entire bottle of the lyse should
be replaced, click [BCC-3D lyse] and it will prompt "Replacing BCC-3D lyse...". If the progress bar disappears,
it means the replacement is completed.
b)Replace diluent:
If the diluent pipe contains bubbles or the diluent is polluted or used up and the entire tube of the diluent need
to be replaced, click [BCC-3D diluent] and it will prompt "Replacing BCC-3D diluent...". If the progress bar
disappears, it means the replacement is completed.
(2)When it is necessary to fill some reagent, proceed as follows:
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Fig. 9-3-6
a)Fill lyse:
When the lyse needs to be filled after emptying, click [BCC-3D lyse], which prompts "Filling BCC-3D lyse".
Wait until the progress bar prompts completion.
b)Fill diluent:
When the diluent needs to be filled after emptying, click [BCC-3D diluent] and it will prompt "Filling BCC-3D
diluent". Wait until the progress bar prompts completion.
9.3.5.2 Rinsing
Click [Menu] - [Maint.] - [Service] and select the [Rinse] tab, as shown in the figure below:
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Fig. 9-3-7
(1)If WBC or HGB parameters are found abnormal in background test, execute "Rinse WBC cell" operation and it
will prompt "Rinsing WBC cell...". The rinsing is finished when the progress bar comes to an end.
(2)If RBC or PLT parameters are found abnormal in background test, execute "Rinse RBC cell" operation and it
will prompt "Rinsing RBC cell...". The rinsing is finished when the progress bar comes to an end.
(3)To avoid the interference to count result caused by the pollution of sampling parts, rinse the swab after every
month of instrument operation.
Execute "Rinse swab" operation and it will prompt "Rinsing swab". The rinsing is finished when the progress bar
comes to an end.
When the instrument has alarm information, it is not allowed to rinse it.
9.3.5.3 Maintenance
Click [Menu] - [Maint.] - [Service] and select the [Maintenance] tab, as shown in the figure below:
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Fig. 9-3-8
(1)Emptying:
During the maintenance of the liquid path system of the instrument, execute drainage before maintenance to
prevent the spill of liquid, the followings are the specification, taking draining WBC cell as an example:
a)Click [WBC cell] to drain the liquid in WBC cell and it will prompt "Draining the WBC cell". The drainage is
finished when the progress bar comes to an end.
The draining steps of "RBC cell", "BCC-3D lyse" and "BCC-3D diluent" are the same as above.
b)When the instrument is not used for 3 to 14 days, click [Pipe] and the message "Empty the pipe" pops up.
Click [OK] to pop up the prompt "Please remove the reagent", take the pipes connecting various reagents out of
the reagent bottles, click [OK] to pop up the message "Empty the pipe". The progress bar ends to complete the
emptying. After the drainage of liquid in tubing, place the instrument at a clean and dry position.
c)When the instrument is not used for more than 14 days, replace the reagent with distilled water, click
[Package rinsing] to prompt "Package rinsing" till the progress bar is over to complete pipe rinsing.
Then disconnect the distilled water, and click [Package emptying] till the interface pops up "Package emptying".
After that, click [OK] to prompt "Please remove the reagent", and remove the pipes connecting various reagents
from the distilled water bottle, click [OK] to prompt "Package emptying" till the progress bar ends to complete
the emptying. After pack rinsing and pack emptying, put the instrument at a clean and dry place.
(2)Aperture:
As sundries will be attached in aperture after long time of using, unblock, cauterize and back wash the aperture to
clear the attached sundries.
a)Click [Cauterize] to cauterize the two ends of the aperture with high voltage DC, and meanwhile, pop up the
progress bar "Cauterize".
Clear sundries blocked in aperture to prevent and eliminate RBC blocking failure.
b)Click [Back washing] to flush the aperture, and meanwhile, pop up the progress bar "Back washing".
Assistance in cauterization can prevent and eliminate RBC blocking failure.
c)Click [Unblocking], a progress bar "Unblocking" pops up, then the instrument will execute cauterization and
back washing. The progress bar ends and the task is complete.
(3)Soak
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To guarantee the accuracy of the testing result of the instrument, soak the WBC cell, RBC cell and
sample-aspirating probe with the probe cleanser in the following cases:
a)The instrument is blocked;
b)The instrument shows abnormal classification.
a)Soak the RBC cell:
Soak and rinse RBC cell every other week, and the operation steps are as below:
Click [RBC cell] and a dialog box as shown below will pop up:
Fig. 9-3-9
Follow the prompt to place the probe cleanser in the aspirating position. Press the count key to start soaking, as
Fig. 9-3-10
After soaking, the interface as shown below pops up:
Fig. 9-3-11
Click [Next] to pop up the prompt box as shown below:
Fig. 9-3-12
After the progress bar is over, click [Complete] to complete the whole operation process.
b)Soak the WBC cell:
Soak WBC cell every other week, and the operation steps are as below:
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Click [WBC cell] and a dialog box as shown below will pop up:
Fig. 9-3-13
Follow the prompt to place the cleanser in the aspirating position. Press the count key to start soaking, as shown
in the figure below:
Fig. 9-3-14
After soaking, the interface as shown below pops up:
Fig. 9-3-15
Click [Next] to pop up the prompt box as shown below:
Fig. 9-3-16
c)Soak the sample aspirating probe:
Soak the sample-aspirating probe every month by the steps below:
Click [Sampling probe] and the dialog box shown below pops up:
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Fig. 9-3-17
Follow the prompt to place the probe cleanser in the aspirating position. Press the count key to start soaking, as
Fig. 9-3-18
9.3.6 HGB verification
Click [Menu] - [Maint.] - [HGB verification], as shown in the figure below:
Fig. 9-3-19
Click [Verification] in the figure, and HGB verification value will be displayed in the box following
"Verification".
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9.3.7 Data backup

Click [Menu] - [Maint.] - [Data backup], as shown in the figure below:
Fig. 9-3-20
After inserting the U disk in the USB interface behind the instrument, click [Backup] on the interface to export the
data to the U disk for saving.
If the user needs to restore the exported data, click [Recover] on the interface to export the data in the U disk into
the instrument.
Data should be backed up regularly to prevent data loss when hardware or software fails.
9.3.8 Counter
Click [Menu] - [Maint.] - [Counter], as shown in the figure below:
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Fig. 9-3-21
Users can view the operating times of the sample-aspirating syringe and the operating time of the positive
pressure pump and negative pressure pump (in unit of s).
9.4 Maintenance of the instrument before stopping using

Take the following measures to maintain the instrument before maintenance or treatment:
(1)Remove reagent bottles and waste liquid tanks at the back of the Analyzer before handling.
(2)Carry only after confirming finishing "pipeline draining for packing".
(3)Use transport machine such as utility trolley for the stable transportation of short distance.
(4)Prevent the aspiration probe from other objects and being damaged during handling and transportation
processes.
(5)Keep the Analyzer vertical, not tilting or side laying when moving and carrying.
(6)Avoid vibration during carrying, and check and adjust the Analyzer after carrying to make sure it is normal
before using.
9.5 Rinsing and maintenance of the instrument

Clean the surface of the instrument regularly to keep it tidy. Wipe the surface with a wet and soft cloth or gauze,
dipped with a small amount of 75% ethanol if necessary. However, please do not wipe the surface of the Analyzer
with any organic solvent to prevent damaging the shell.
In rinsing, the operator shall pay attention to the following matters:
(1)Take proper disinfection measures in case of hazardous substance leaked on the surface or inside the
equipment.
(2)Don't use the cleanser or sanitizer with possibility of danger due to chemical reaction with parts or materials in
equipment. (Soft cloth dipped with a small amount of 75% ethanol can be used for disinfection)
(3)In case of doubts about the compatibility between sanitizer or cleanser and parts or materials in equipment,
please consult the manufacturer or its agencies.
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9.6 Disposal of waste liquid

The instrument will produce waste liquid containing clinic whole-blood and reagent for analysis of blood cells
during normal operation period, and according to the national laws and regulations, the waste liquids shall be
discharged only after disinfection. The waste liquid produced by the instrument shall be disposed in accordance
with the following requirements before discharging:
The "84 disinfectant" and waste fluid can be mixed up at scale of 1:50 for disinfection before discharging.
Please handle the waste fluid of the instrument to prevent potential biological and chemical pollution.
9.7 Disposal of scrapped instruments

Do not abandon the Analyzer randomly after its service life expires but inform of the manufacturer for recycle.
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Chapter 10 System log
10.1 System log

Click [Menu] - [System log] to display [All logs], as shown in the figure below:
Fig. 10-1-1
The operator can also select [Operation logs], [Fault logs], and [Other logs] in the interface tab to view.
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Chapter 11 Reagent management
11.1 Reagent registration

Click [Menu] - [Reagent], as shown in the figure below:
Fig. 11-1-1
The interface shows the reagent type, reagent volume, and expiration date. If the current reagent becomes invalid,
it will be marked red in the life information column.
Click [Register], as shown in the figure below:
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Fig. 11-1-2
(1)Input bar code information:
If external barcode reader is not connected, input barcode information manually, and the operation is shown as
below:
Click the input box to correctly input the bar code information on the outer case of the reagent packing box (click
[Empty] to empty the error message and enter new message), and click [Register]. After successful registration,
registration information changes accordingly.
(2)Scan and input barcode information:
Connect the bar code reader correctly (the other end of the bar code reader data cable is connected to the
instrument "USB" port), click the input box after the "bar code number" (make the input executable), scan the bar
code on the reagent bottle with the bar code reader to make the bar code is automatically generated in the input
box after the "bar code number", and click [Register]. After the registration is successful, the screen displays
"Registration is successful."
(3)Relevant prompt in case of failed scanning:
When "Registration fails and the format of the bar code number is wrong" is prompted, check the input bar code
to see if it contains special characters.
When "Registration fails and the parsing of the bar code number is wrong" is prompted, check whether the input
bar code is correct.
When "Registration fails and the bar code has been registered" is prompted, repeat registration after replacing the
reagent.
When "Registration fails and the reagent expires", replace the reagent and register it again.
If there are other prompts, contact the manufacturer or agent.
(4)After the reagent registration is successful, replace the corresponding reagent on the interface of [Menu] -
[Maint.] - [Service] - [Replace].
The instrument reagent bar code does not allow cumulative registration. Registering a new bar code will
remove the original reagent remaining volume.
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11.2 Reagent settings

Select the corresponding reagent and click [Setting], as shown in the figure below:
Fig. 11-2-1
Modify the corresponding reagent life. After that, click [Save] to exit the settings interface and return to the
interface in Fig. 11-1-1.
If the selected reagent residual is 0, the life cannot be set, as shown in the figure below:
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Fig. 11-2-2
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Chapter 12 Alarm information and processing

This chapter introduces all possible faults of the instrument, the analyses of fault causes, as well as the relating
handling method.
Analyzing the sample in the event of a failure may result in incorrect analysis. If a fault alarm occurs
during sample analysis, be sure to perform sample analysis after troubleshooting.
12.1 General
When the instrument fails, an alarm message will be displayed in the fault information area. In the "Shortcut key
area", click (fault information area), as shown in the figure below:
Fig. 12-1-1
The fault information is displayed in the order of occurrence of faults: the last fault message is displayed at the
top.
After selecting the corresponding fault information, view the solution to the selected fault in the "Alarm help"
column.
Then, press [Clear alarm] to clear the fault information, as shown in the figure below:
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Fig. 12-1-2
After clearing, click [Close] to close the dialog box. If the alarm is not cleared or a new alarm occurs during the
process, refer to the "Alarm help" column.
12.2 Alarm information and troubleshooting

Alarm code Alarm level Alarm message treatment measures
1. Click the "Clear" button to automatically clear
02-101-01 Stop Syringe motor failure the fault.
2. Check whether the syringe motor breaks down.
the fault.
02-101-02 Stop Syringe motor sensor failure
2. Check whether the syringe motor sensor
breaks down.
02-101-03 Stop Syringe motor failure the fault.
2. Check whether the syringe motor breaks down.
the fault.
02-101-04 Stop X-axis motor failure
2. Check whether the X-axis motor is out of
order.
the fault.
02-101-05 Stop X-axis motor sensor failure
2. Check whether the X-axis motor sensor is out
of order.
the fault.
02-101-06 Stop X-axis motor failure
2. Check whether the X-axis motor is out of
order.
the fault.
02-101-07 Stop Y-axis motor failure
2. Check whether the Y-axis motor is out of
order.
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the fault.
02-101-08 Stop Y-axis motor sensor failure
2. Check whether the Y-axis motor sensor is out
of order.
the fault.
02-101-09 Stop Y-axis motor failure
2. Check whether the Y-axis motor is out of
order.
02-131-01 Stop SV1 valve fault
02-131-05 Stop SV5 valve fault 1. Click the "Clear" button to automatically clear
the fault.
02-131-06 Stop SV6 valve fault 2. Check whether the solenoid valve is faulty.
Gas negative pressure is too 1. Click the "Clear" button to automatically clear
02-92-01 Stop the fault.
high
2. If the fault still exists, check whether the
Gas negative pressure is too vacuum pump is working.
02-92-02 Stop 3. Please check the air pipe connection to see if
low
correct.
Gas positive pressure is too the fault.
02-92-03 Stop
high 2. If the fault still exists, check whether the
positive pressure pump is working.
02-92-04 Stop Gas positive pressure is too low 3. Please check the air pipe connection to see if
correct.
1. Check whether the diluent reagent is sufficient.
02-111-01 Stop Insufficient diluent 2. If there is no reagent, use the new reagent.
Then clear the fault.
1. Check whether the lyse is sufficient.
02-111-02 Stop Insufficient lyse 2. If there is no reagent, use the new reagent.
Then clear the fault.
Abnormal voltage of WBC cell the fault.
02-201-01 Stop
holes 2. If the fault still exists, please execute the
"Unblock" function.
Abnormal voltage of RBC cell the fault.
02-201-02 Stop
holes 2. If the fault still exists, please execute the
"Unblock" function.
1. Check whether the diluent is contaminated.
Abnormal HGB background
02-201-03 Stop 2. If there is no pollution, click the "Clear" button
voltage
to eliminate this failure.
The ambient temperature is too 1. Ensure that the ambient temperature is in the
02-91-01 CAUTION
low normal range [15.30]℃.
Ambient temperature is loo the fault.
02-91-02 CAUTION
high 3. If the fault still exists, replace the temperature
sensor.
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the fault.
2. If the fault still exists, replace the temperature
Ambient temperature sensor
02-91-03 CAUTION sensor to see if reliably connected.
failure
3. Check the temperature sensor to see if
damaged, and if yes, replace the temperature
sensor.
the fault.
01-201-02 Stop Abnormal communication
2. If the fault still exists, please contact the
after-sales engineer.
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Chapter 13 Transportation and storage
13.1 Transportation
The transport of Analyzer is specified in the contract, during which fierce collision and placing together with
corrosive materials shall be prevented.
13.2 Storage
The packed instrument shall be placed in a well-ventilated room with temperature at -40℃~55℃, relative
humidity not more than 93% and where no corrosive gas exists.
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Appendix A Network communication interface protocol V1.1

A.1 Network communication interface protocol V1.1
The protocol is applicable to information transmission between Automatic Hematology Analyzer (model:
BCC-3900/BCC-3960) and the upper computer (LIS). It is in compliance with HL7 standard, and the HL7 version
is 2.3.1.
A.2 Definitions
Message header (MSH): the first portion of each message is used to define the purpose and usage of messages,
and each message consists of several sections. The first segment of a message is the message head segment which
shows the program name, message type and the only message ID number for sending and reception, and the
composition of the following segments is determined by the message type. For example, a sample message is
transmitted by the section format OBR, and a test result message is transmitted by several OBX sections.
Segment: a message section consists of several data fields and each segment is provided with a name to define its
contents and function. For example, MSH, PID, and PV1.
Data field: a message section consists of several data fields. The fields are separated by separators.
A.3 Grammatical format
<SB>dddd <EB><CR>
<SB>: message start character (1 byte). ASCII character <VT>, i.e. 0x0B.
dddd: data (composed of different length of bytes). This is HL7 data contents of the block. The data can contain
any values of single byte greater than the hexadecimal value 0x1F and carriage return of ASCII code, <CR>.
<EB>: message end character (1 byte). ASCII character <FS>, i.e. `0x1C.
<CR>: carriage return (1 byte). ASCII character <CR>, i.e. 0x0D.
Things such as:
<SB>MSH|^~\&|BCC3900| X1706900BF0001|||20090419104618||ORU^R01|1|P|2.3.1|||||CHN|UTF-8<CR>
<EB><CR>
Wherein:
The five characters after MSH are separators among data fields, assemblies and sub-assemblies. Although those
characters are any non-text characters, the characters in the table below are recommended in HL7 standard:
Delimiter Value
Data field separator |
Component separator ^
Sub-component separator &
Repeating delimiter ~
Quoting character \
A.4 Message section of the protocol

(1)MSH - Message header
(2)PID - Patient information
(3)PV1 - Case
(4)OBR - Testing report information
(5)OBX - Testing report detection information
(6)MSA - Response
(7)ORC - Application
A.5 HL7 attribute list
The message sections of the agreement are classified as required, optional and repeatable.
A.5.1 MSH definition list
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MSH – message header: this section is required, including the basic information of HL7 message like the value of
message separator, message type and encoding system, and it is the first section of each HL7 message.
Message example:
MSH|^~\&|BCC3900| X1706900BF0001|||20090419104618||ORU^R01|1|P|2.3.1|||||CHN|UTF-8<cr>
HL7
S/N Field name Length recommended Description Examples
length
The first field separator after the name of
Field the message section which defines the
1 1 1 |
separator values of section separators of the other
parts.
Component separator, repetition
Coded
2 4 4 separator, escaping separator, and ^~\&
character
sub-component separator.
Sender
3 7 180 Sender application program, value: XXX XXX
program
Instrument Sender equipment, value: instrument
4 10 180 1234567890
code code
Time of current message. To call the
time information of the system.
Send time message to create time (in the
7 Sending time 14 26 form of 20090419104618
YYYY[MM[DD[HH[MM[SS]]]]]), and
take the system time value. For instance,
20110310144704
The type of message, such as ORU^R01.
The format is "Message typeÊvent
9 MessageType 7 7 ORU^R01
type^Message structure name".
Value: ORU^R01 (sample)
Message The message control ID is used to
10 20 20 361
control ID uniquely identify a message. Value: PID
Process ID and always take P (indicating
Disposal ID
11 3 3 sample and worklist query information); P
number
Q (QC count resultS)
HL7 version The protocol uses HL7 version No.
12 3 60 2.3.1
No. Value: 2.3.1
The worldwide character standard in
18 Charactor set 10 10 UTF-8
ISO/IEC 10646-1-1993, value: UTF-8
A.5.2 PID definition list

PID – patient information: optional, used for transmission of patient sample, including case No., name, age and
sex
Message example:
PID|1||7393670||Liu Jia|||F|||||||||||||||||||||||||25^Y<cr>
HL7
length
3 Case No. 16 16 Patient ID, the case No. here 1234567890
5 Name 30 30 Patient name Wang Sanqiang
Sex Male, sent as M; sex Woman, sent as
8 Gender 1 1 F
F; and others sent as O.
Age and age unit. The age and age unit
are separated by ^. The age unit is a
31 Age 5 5 character string with a length of 1. Y 25^Y
stands for year, M for month, D for day,
and H for hour.
A.5.3 PV1 definition list

PV1 - Patient admission information: This message segment is optional and is used for transmission of patient
samples, including departments, charges, etc.
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Message example:
PV1|1||Internal Medicine||||||||||||||||||| self-paid<cr>
HL7
Field
S/N Length recommended Description Examples
name
length
It is used to mark the different OBX
1 Serial no. 4 4 1
sections in the message.
Patient location information, indicated in
3 Division 80 80 the form of Outpatient
"Department"
Expense
20 50 50 Charge type, character string Self Pay
type
A.5.4 OBR definition list

OBR - Inspection report information: This message section is optional and mainly contains inspection report
information, including sample numbers, inspection time, and so on.
Message example:
OBR||23|31C3F010230DFB03|1001^CountResults||20071207080000|20071207160000||||||
|20071207083000||||2311|322<cr>
HL7
S/N Field name Length recommende Description Examples
d length
Number of the doctor's advice for the
requester, used as the sample bar code
2 Bar code 22 22 No. 1A2165C24B
Bar code ID for detection
Lot No. in LJ/X QC
Number of doctor's advice of the
No. of executor, used as the sample No. Sample
3 12 12 20090807011
samples: ID for detection
File No. in LJ/Xbar QC
Service mark, for identifying different
Date
counting results. Specific values and
4 servicing 200 200 1001^Count Results
parameter are shown in the appendix:
type
OBR-4 message code definition.
Request time/date. Sampling time in
Sampling
6 14 26 sample detection 20090807140600
time
Validity in LJ/Xbar QC
Counting time in sample information
Counting
7 14 26 Counting time in LJ/Xbar QC 20090807150616
time
Counting time in X-B QC
10 Submitter 8 8 Submitter Dr
Date of
14 sample 14 26 Date of sample sending 20090807150000
sending
Check Attending doctor, for examination
20 30 30 Dr
doctor doctor.
Result report date/time, used for audit
22 Audit Date 26 26 20090807153000
time
28 Reviewer 150 150 Copy of results for reviewers Dr
A.5.5 OBX definition list

OBX -Test result: repeatable, mainly including the test result parameters, analysis modes, reference groups, etc.
Message example:
OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00| |||F|| <cr>
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User’s Manual
HL7
length
Serial No. It is used to mark the different OBX sections
1 10 10 1
ID of message.
Date type of test result, including "ST",
2 Data type 3 3 ED
"NM", "ED" and "IS"
Test item mark. The form is "ID^Name", ID
is the test item mark, and the Name is
description of test item. The coding value of
testing items are shown in appendix:
3 Identifier 250 250
definition of identifier code. Note: ID is the
only way to confirm the test parameter, but
the Name is used for description instead of
marking.
Test result data can be numbers or words.
Test result,
Strings, enumeration values, binary data, and
graphic 4.63
so on [Histograms and scatterplots and the
5 data, 65536 65536
like converted using Base64 encoding]
remarks, Xbar-r 5.5^1.1
Remarks: Xbar-R
QC level...
QC data format is Xbar-R.
Unit, used for the testing result value. ISO
6 Unit 12 250 10*9/L
standard unit is adopted.
Reference
Test result range, format: "lower limit-upper
7 value of 30 60 12.463-33.569
limit of reference value”
test results
Test result Test result status. The value is "F" -
11 20 20 F
status (Final Result) which means the final result.
A.5.6 ORC definition table

ORC-Message segment mainly contains Order-related information.
Message example:
ORC|RF||SampleID||IP <cr>
HL7
length
Order control Value: RF in ORM indicates request; AF in
1 2 2 RF
word ORR message indicates confirmation.
Originator Originator number of Order
2 number of 22 22 ORM message is empty, while ORR
Order message is bar code number.
Receiver number of Order
Receiver
There is a bar code number in the ORM
3 number of 22 22 SampleID
message and empty value in the ORR
Order
message.
In the worklist query ORM information,
take the value and fix it to IP, indicating
5 Order status 2 2 that the Order is processing and the result IP
has not been obtained; the value in the
ORR is null.
A.5.7 MSA definition table

The MSH segment of the interface includes the following domains:
HL7
length
Confirmation Confirmation code, AA indicating
1 2 2 AA
code acceptance, AE error, and AR rejection
Message The message control ID is same to the
2 20 20 1
control ID MSH-10 of the sender.
Bad Error condition (status code). See the figure
6 100 100
Condition below for details
The value of MSA-6 field is shown in the table below:
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User’s Manual
Status code (MSA-6) Status text (MSA-3) Description/Remark

successful AA
0 Message accepted Succeeded
Error status code AE
Sequence of middle message segment is incorrect or
100 Segment sequence error
necessary fields are missing.
101 Required field missing Necessary fields in a segment are missing.
102 Data type error Field data type error, like the figure is written in character.
103 Table value not found Tabular value not found, not used temporarily.
Status code rejected AR
200 Unsupported message type Message type nonsupport.
201 Unsupported event code Event code nonsupport.
202 Unsupported processing id Handling ID nonsupport.
203 Unsupported version id Version ID nonsupport.
Unclear keyword mark, like transmitting the information of a
204 Unknown key identifier
nonexistent patient.
205 Duplicate key identifier Existing repeated keyword.
Affair cannot be executed in application program storage
206 Application record locked
level, like database being locked.
207 Application internal error Other unknown internal error of application.
The protocol applies the custom coding mode.

A.6 OBR-4 coding definition
Code Title Description OBR-4 field
1001 Count Results Sample counting result 1001^ Count Results
1002 LJ QC LJ QC count results 1002^LJ QC
1003 Xbar QC Xbar QC count results 1003^Xbar QC
1004 XB QC X-B QC counting result 1004^XB QC
1006 XbarR QC Xbar-R QC count results 1006^XbarR QC
A.7 OBX-3 identifier code definition

Code Title Description Value type OBX-3 field
2001 MODE Analysis mode IS 2001^MODE
2003 Ref Reference group IS 2003^Ref
2004 Note Remarks ST 2004^Note
2005 Level L-J/Xbar QC level IS 2005^Level
Total number of white blood
2006 V_WBC NM 2006^V_WBC
cell
2007 V_NEU_p Percentage of maxicell NM 2007^V_NEU_p
2008 V_LYM_p Percentage of cellule NM 2008^V_LYM_p
2009 V_MXD_p Medium cell percentage NM 2009^V_MXD_p
2012 V_NEU_c Large cell number NM 2012^V_NEU_c
2013 V_LYM_c Small cell number NM 2013^V_LYM_c
2014 V_MXD_c Medium cell number NM 2014^V_MXD_c
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Code Title Description Value type OBX-3 field

2017 V_RBC Number of red blood cell NM 2017^V_RBC
2018 V_HGB Hemoglobin NM 2018^V_HGB
2019 V_MCV Mean red blood cell volume NM 2019^V_MCV
2020 V_HCT RBC hematocrit NM 2020^V_HCT
Mean red blood cell
2021 V_MCH NM 2021^V_MCH
hemoglobin content
Mean red blood cell
2022 V_MCHC NM 2022^V_MCHC
hemoglobin concentration
Standard deviation of red
2023 V_RDW_SD NM 2023^V_RDW_SD
blood cell distribution width
Red blood cell distribution
2024 V_RDW_CV NM 2024^V_RDW_CV
width variation coefficient
2025 V_PLT Number of platelet NM 2025^V_PLT
2026 V_MPV Mean platelet volume NM 2026^V_MPV
2027 V_PCT Platelet hematocrit NM 2027^V_PCT
2028 V_PDW Platelet distribution width NM 2028^V_PDW
2029 V_P_LCR Platelet - ratio of macrophage NM 2029^V_P_LCR
2030 V_P_LCC Platelet ratio NM 2030^V_ P_LCC
WBC Histogram. 2101^WBC Scattergram.
2101 WBC histogram PNG data ED
PNG PNG
2102^RBC Scattergram.
2102 RBC Histogram. PNG RBC histogram PNG data ED
PNG
2103^PLT Scattergram.
2103 PLT Histogram. PNG PLT histogram PNG data ED
PNG
A.8 Enumeration type list

Data item Value
Analysis mode 0 - Whole blood 1 -Trace whole blood 2 -Pre-dilution
0 - Normal 1 - Male 2 - Female 3 - Child 4 - Newborn 5 -Self-defined 16- Self-defined 27
Reference group -Self-defined 38 -Self-defined 4
9 -Self-defined 5
L-J/Xbar QC level 0-high 1-middle 2-low
Example of a complete message section:

(1)Patient sample
<SB>MSH|^~&|BCC-3900|machineid3900|||20180601163818||ORU^R01|2|P|2.3.1||||||UTF-8<cr>
PID|1||patientid||Zhang Liuliu|||F|||||||||||||||||||||||1^Y<cr>
PV1|||emergency diagnosis||||||||||||||||||||self-paid<cr>
OBR|||7250|1001^CountResults||20180601162959|20180601162959|||||||20180601162959||||||dirui||||||||<cr>
OBX|1|IS|2001^MODE||0||||||F||<cr>
OBX|2|IS|2003^Ref||0||||||F||<cr>
OBX|3|IS|2004^Note||for remarks||||||F||<cr>
OBX|4|NM|2006^V_WBC||4.02|10^9/L|4-10|H|||F||<cr>
OBX|5|NM|2013^V_LYM_c||1.51|%|0.6-3.5|H|||F||<cr>
OBX|6|NM|2014^V_MXD_c||0.54|%|0.1-0.9|H|||F||<cr>
OBX|7|NM|2012^V_NEU_c||1.97|%|1.3-6.7|H|||F||<cr>
OBX|8|NM|2008^V_LYM_p||37.6|%|14-53|H|||F||<cr>
OBX|9|NM|2009^V_MXD_p||13.6|%|3-16|H|||F||<cr>
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User’s Manual
OBX|10|NM|2007^V_NEU_p||48.8|10^9/L|30-90|H|||F||<cr>
OBX|11|NM|2017^V_RBC||4.07|10^9/L|3.5-5.5|H|||F||<cr>
OBX|12|NM|2018^V_HGB||121|10^9/L|110-160|H|||F||<cr>
OBX|13|NM|2019^V_MCV||89.8|10^9/L|80-100|H|||F||<cr>
OBX|14|NM|2020^V_HCT||0.366|10^9/L|0.35-0.5|H|||F||<cr>
OBX|15|NM|2021^V_MCH||29.7|10^12/L|27-34|H|||F||<cr>
OBX|16|NM|2022^V_MCHC||331|g/L|320-360|H|||F||<cr>
OBX|17|NM|2023^V_RDW_SD||44|fL|35-56|H|||F||<cr>
OBX|18|NM|2024^V_RDW_CV||12|L/L|11-16|H|||F||<cr>
OBX|19|NM|2025^V_PLT||251|pg|100-300|H|||F||<cr>
OBX|20|NM|2026^V_MPV||10.5|g/L|7-13|H|||F||<cr>
OBX|21|NM|2027^V_PCT||0.263|fL|0.1-0.28|H|||F||<cr>
OBX|22|NM|2028^V_PDW||10.7|%|15-18|H|||F||<cr>
OBX|23|NM|2029^V_P_LCR||26.2|10^9/L|13-43|H|||F||<cr>
OBX|24|NM|2030^V_P_LCC||66|fL|13-129|H|||F||<cr>
OBX|25|ED|2101^V_WBCScattergram.PNG||……PNG binary data converted into BASE64
coding……||||||F||<cr>
OBX|26|ED|2102^V_RBCScattergram.PNG||……PNG binary data converted into BASE64 coding……||||||F||<cr>
OBX|27|ED|2103^V_PLTScattergram.PNG||……PNG binary data converted into BASE64 coding……||||||F||<cr>
<EB><CR>
(2)L-J QC
<SB>MSH|^~&|BCC-3900||||20180601164026||ORU^R01|3|Q|2.3.1||||||UTF-8<cr>
PID|1||||||||||||||||||||||||||||||^<cr>
PV1||||||||||||||||||||<cr>
OBR|||1|1002^LJQC||20180601|20180517161103|||||||||||||||||||||<cr>
OBX|1|IS|2005^Level||1||||||F||<cr>
OBX|2|NM|2006^V_WBC||7.12|10^9/L|0-0|H|||F||E<cr>
OBX|3|NM|2013^V_LYM_c||2.84|%|0-0|H|||F||E<cr>
OBX|4|NM|2014^V_MXD_c||0.52|%|0-0|H|||F||E<cr>
OBX|5|NM|2012^V_NEU_c||3.76|%|0-0|H|||F||E<cr>
OBX|6|NM|2008^V_LYM_p||39.9|%|0-0|H|||F||E<cr>
OBX|7|NM|2009^V_MXD_p||7.4|%|0-0|H|||F||E<cr>
OBX|8|NM|2007^V_NEU_p||52.7|10^9/L|0-0|H|||F||E<cr>
OBX|9|NM|2017^V_RBC||4.75|10^9/L|0-0|H|||F||E<cr>
OBX|10|NM|2018^V_HGB||85|10^9/L|0-0|H|||F||E<cr>
OBX|11|NM|2019^V_MCV||77|10^9/L|0-0|H|||F||E<cr>
OBX|12|NM|2020^V_HCT||0.366|10^9/L|0-0|H|||F||E<cr>
OBX|13|NM|2021^V_MCH||17.7|10^12/L|0-0|H|||F||E<cr>
OBX|14|NM|2022^V_MCHC||231|g/L|0-0|H|||F||E<cr>
OBX|15|NM|2023^V_RDW_SD||41.5|fL|0-0|H|||F||E<cr>
OBX|16|NM|2024^V_RDW_CV||14|L/L|0-0|H|||F||E<cr>
OBX|17|NM|2025^V_PLT||265|pg|0-0|H|||F||E<cr>
OBX|18|NM|2026^V_MPV||11.1|g/L|0-0|H|||F||E<cr>
OBX|19|NM|2027^V_PCT||0.295|fL|0-0|H|||F||E<cr>
OBX|20|NM|2028^V_PDW||15.2|%|0-0|H|||F||E<cr>
A-7
User’s Manual
OBX|21|NM|2029^V_P_LCR||34.6|10^9/L|0-0|H|||F||E<cr>
<EB><CR>
(3)Xbar-R QC
PID|1||||||||||||||||||||||||||||||^<cr>
PV1||||||||||||||||||||<cr>
OBR|||1|1006^XbarRQC||20180601|20180601164727|||||||||||||||||||||<cr>
OBX|1|IS|2005^Level||1||||||F||<cr>
OBX|2|NM|2006^V_WBC||4.2^0.12|10^9/L|||||F||<cr>
OBX|3|NM|2013^V_LYM_c||1.655^0.05|%|||||F||<cr>
OBX|4|NM|2014^V_MXD_c||0.46^0.1|%|||||F||<cr>
OBX|5|NM|2012^V_NEU_c||2.085^0.170001|%|||||F||<cr>
OBX|6|NM|2008^V_LYM_p||39.6^0|%|||||F||<cr>
OBX|7|NM|2009^V_MXD_p||11.1^2.6|%|||||F||<cr>
OBX|8|NM|2007^V_NEU_p||49.3^2.6|10^9/L|||||F||<cr>
OBX|9|NM|2017^V_RBC||4.71^0|10^9/L|||||F||<cr>
OBX|10|NM|2018^V_HGB||139.5^1|10^9/L|||||F||<cr>
OBX|11|NM|2019^V_MCV||87.9^0.199997|10^9/L|||||F||<cr>
OBX|12|NM|2020^V_HCT||0.4135^0.00100002|10^9/L|||||F||<cr>
OBX|13|NM|2021^V_MCH||29.65^0.299999|10^12/L|||||F||<cr>
OBX|14|NM|2022^V_MCHC||337.5^3|g/L|||||F||<cr>
OBX|15|NM|2023^V_RDW_SD||43.2^1.6|fL|||||F||<cr>
OBX|16|NM|2024^V_RDW_CV||12.7^0|L/L|||||F||<cr>
OBX|17|NM|2025^V_PLT||222^4|pg|||||F||<cr>
OBX|18|NM|2026^V_MPV||11.95^0.1|g/L|||||F||<cr>
OBX|19|NM|2027^V_PCT||0.2665^0.00300002|fL|||||F||<cr>
OBX|20|NM|2028^V_PDW||14.45^0.7|%|||||F||<cr>
OBX|21|NM|2029^V_P_LCR||39.25^0.300003|10^9/L|||||F||<cr>
<EB><CR>
(4)X-B QC
PID|1||||||||||||||||||||||||||||||^<cr>
PV1||||||||||||||||||||<cr>
OBR||||1004^XBQC|||20180531163912|||||||||||||||||||||<cr>
OBX|1|NM|2019^V_MCV||92.295|fL|0-0|H|||F||E<cr>
OBX|2|NM|2021^V_MCH||30.16|pg|0-0|H|||F||E<cr>
OBX|3|NM|2022^V_MCHC||327.15|g/L|0-0|H|||F||E<cr>
<EB><CR>
(5)Apply worklists
<SB>MSH|^~&|BCC-3900||||20180601164215||ORMÔ01|4|P|2.3.1||||||UTF-8<cr>
ORC|RF||000087||IP<cr>
<EB><CR>
(6)Acquire worklists
<SB>MSH|^~\&|LIS||||20180601164314||ORRÔ02|4|P^S|2.3.1||||||UTF8<cr>
A-8
User’s Manual
MSA|AA|1||||0<cr>
PID|1||3||T3|||M|||||||||||||||||||||||3^Y<cr>
PV1|1||orthopedics|||||||||||||||||medical insurance<cr>
ORC|AF|000087|||<cr>
OBR|1|000087|3|1001^Count ||20180601163736||||Doctor Zhang||||20180601163746||||||||||||||||<cr>
OBX|1|IS|2001^MODE||0||||||||<cr>
OBX|2|IS|2002^MODE_EX||1||||||||<cr>
OBX|3|IS|2003^Ref||0||||||||<cr>
OBX|4|ST|2004^Note||test||||||||<cr>
<EB><CR>
A-9
User’s Manual
A-10
User’s Manual
Appendix B Letter of guarantee

Dear users,
Thanks for buying the Automatic Hematology Analyzer (model: BCC-3900/BCC-3960). Our company will offer
the following services:
(1)Technical consultation at any time.
(2)One-year free repair since the date of purchase.
(3)Paid services in the following cases:
a)The product out of warranty.
b)Product damage due to an accident or improper use.
c)Product damage due to non-compliance with the manual or self-repair.
Due to the technical advancement, the company will provide the upgrading service for Automatic Hematology
Analyzer (model: BCC-3900/BCC-3960).
Please contact us according to the following information:

After-Sale Service From: DIRUI INDUSTRIAL CO., LTD.
Address: 3333 Yiju Road, New & High Tech. Development Zone Changchun, Jilin 130103, the People’s Republic
of China
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: 0431-85100405
Domestic Customer Service E-mail: service.ch@dirui.com.cn
B-1
User’s Manual
B-2
User’s Manual
Appendix C Product description

C.1 Product classification
According to Product Classification Catalog of Medical Devices:
The Analyzer is a blood analyzer belonging to clinical analyzers (6840), and the management class is Class II.
C.2 Product matching reagent
(1)BCC-3D diluent for 3-diff Hematology Analyzer (hereinafter referred to as diluent)
(2)BCC-3D lyse for 3-diff Hematology Analyzer (hereinafter referred to as lyse)
C.3 Consumption of product matching reagent
Operating Operating
Reagent consumption Reagent consumption
Instructions Instructions
System sleep Diluent (22±1)mL Diluent (34±2)mL
Soak WBC
System wakeup Diluent (30±2) mL Cleanser (2±0.2)mL
Diluent (70±5)mL Diluent (34±2)mL
Turn on Soak RBC
Lyse 1mL Cleanser (2±0.2)mL
Diluent (30±10)mL Rinse swab Diluent (24±2)mL
Shutdown Rinse the
Cleanser 2mL Diluent (22±1) mL
WBC cell
Rinse the RBC
Diluent (38±2)mL Diluent (22±1) mL
cell
Rinsing
equipment Cleanser (2±0.2)mL Unblocking Diluent (16±1)mL
Back washing Diluent (16±1)mL
Operating Reagent volume for Operating Reagent volume for

Instructions filling/rinsing pipes Instructions filling/rinsing pipes
Lyse (5±1)mL Fill diluent Diluent (30±2) mL
Replace lyse
Diluent (28±1) mL Fill lyse Lyse (3.5±1)mL
Replace diluent Diluent (51±5) mL
Reagent consumption for one-time test

Diluent (22±2)mL
Lyse 1mL
C-1
User’s Manual
C.4 Description of parameters

Parameters from histogram
Title Abbreviation Default unit
Percentage of cellule LYM% %
Percentage of intermediate cell MXD% %
Percentage of maxicell NEU% %
Mean red blood cell volume MCV fL
Red blood cell distribution width variation coefficient RDW-CV %
Red blood cell distribution width deviation limit RDW-SD fL
Mean platelet volume MPV fL
Platelet distribution width PDW %
Calculated parameters
Title Abbreviation Default unit
9
Number of cellule LYM# 10 /L
Number of intermediate cell MXD# 109/L
Number of maxicell NEU# 109/L
RBC hematocrit HCT L/L
Mean red blood cell hemoglobin content MCH pg
Mean red blood cell hemoglobin concentration MCHC g/L
Platelet hematocrit PCT %
C-2
User’s Manual
Appendix D Performance index

D.1 Blank counting
(1)RBC≤0.02×1012/L;
(2)WBC≤0.2×109/L;
(3)HGB≤1g/L;
(4)PLT≤5×109/L.
D.2 Linearity
The linear range and deviation of the Analyzer shall conform to Table D-2-1:
Table D-2-1 Linear requirements of the Analyzer
Linearly dependent
Parameter Linear range Allowable deviation range
coefficient (r)
(0-10.0)×109/L Not exceeding ±0.3×109/L
WBC (10.1-100.0)×109/L No exceeding ±5.0% ≥0.990
(100.1-300.0)×109/L No exceeding ±10.0%
(0-1.00)×1012/L Not exceeding ±0.03×1012/L

RBC ≥0.990
(1.01-8.00)×1012/L Not exceeding ±3.0%
(0-70) g/L Not exceeding ±2.0g/L

HGB ≥0.990
(71-280) g/L Not exceeding ±2.0%
(0-100)×109/L Not exceeding ±10.0×109/L
PLT (101-1000)×109/L No exceeding ±5.0% ≥0.990
(1001-5000)×109/L Not exceeding ±12.0%
D.3 Precision
The precision of the Analyzer shall conform to Table D-3-1
Table D-3-1 Requirements on precision of the Analyzer
Parameter Detection range Precision
(3.5-6.9)×109/L ≤3.0%
WBC
9
(7.0-15.0)×10 /L ≤2.0%
(3.50-5.50)×1012/L ≤1.5%
RBC
(5.51-6.50)×1012/L ≤1.5%
(110-160) g/L ≤1.5%

HGB
(161-180) g/L ≤1.5%
(100-149)×109/L ≤5.0%
PLT
(150-500)×109/L ≤4.0%
HCT (30-50) % ≤1.5%
(70-100) fL ≤1.0%
MCV
(101-120) fL ≤1.0%
D.4 Accuracy
The accuracy deviation of the Analyzer shall conform to Table D-4-1:
D-1
User’s Manual
Table D-4-1 Requirements on accuracy of the Analyzer
Parameter Detection range Allowable deviation range

9
WBC (3.5-9.5)×10 /L Not exceeding ±4.5%
RBC (3.80-5.80)×1012/L Not exceeding ±2.0%
HGB (115-175) g/L Not exceeding ±2.0%

9
PLT (125-350)×10 /L Not exceeding ±7.0%
(35-50)%(HCT)
HCT or MCV Not exceeding ±2.0%
Or (82-100) fL(MCV)
D.5 Carry-over rate

The carrying pollution rate of the Analyzer shall meet the following requirements:
(1)RBC≤0.5%;
(2)WBC≤0.5%;
(3)HGB≤0.5%;
(4)PLT≤0.5%.
D.6 Histogram
The histogram of normal fresh blood measurement shall clearly show the maxicells intermediate cells and cellules
and report their percentage results.
D-2
User’s Manual
Appendix E Parts list

Parts list (including parts, accessories and consumables)
Part name Location Replacement cycle Replacing method Remarks

This part can be
Please contact
Syringe pump Syringe unit 30,000 samples checked/replaced by the
customer service staff
manufacturer/agency only
This part can be
Positive 3000 hours Please contact
Pump unit checked/replaced by the
pressure pump (Continuous work) customer service staff
This part can be
3000 hours Please contact
Vacuum pump Pump unit checked/replaced by the
(Continuous work) customer service staff
This part can be
HGB light 10,000/hour Please contact
Counting unit checked/replaced by the
source (Continuous work) customer service staff
Thermal
Built-in printer 100 records 2.3
printing paper
E-1
User’s Manual
E-2
User’s Manual
Appendix F Statement on electromagnetic compatibility

(1)Emission
Radiation emission and conduction emission conforms to Group 1 Class A of CISPR 11 group classification
requirements, and is not applicable to 61000-3-2: 2014 and 61000-3-3: 2013 standards.
(2)Immunity
Performance
Port Test items Basis standard Test value
criterion
Electrostatic Contact discharge 4kV; Air discharge

IEC 61000-4-2 B
discharge (ESD) 8kV
Radiated 3V/m
Shell electromagnetic IEC 61000-4-3 (80MHz～2.0GHz), 80%AM, A
fields modulation frequency 1kHz
Rated
power-frequency IEC 61000-4-8 3A/m, 50Hz A
magnetic field
0%, 1 cycle B
Voltage sag IEC 61000-4-11 40%, 5 cycles B
70%, 25 cycles C
AC power
supply
Voltage
(including IEC 61000-4-11 5% duration, 250 cycles C
interruption
protective
grounding)
Pulse train IEC 61000-4-4 lkV(repetitive frequency: 5kHz) B
Surge IEC 61000-4-5 1kV line to line, 2kV line to ground B
Radio-frequency 3V 150 kHz～80 MHz, 80%AM,

IEC 61000-4-6 A
conduction modulation frequency 1kHz
Pulse train IEC 61000-4-4 lkV(repetitive: 5kHz) B

I/O signal
/control Radio-frequency
IEC 61000-4-6 3 V,150 kHz～80 MHz, 80%AM A
conduction
Performance judgement:
A. Performance is normal within specification limits during the test.
B. During the test, the function or performance is temporarily reduced or lost, but it can recover on its own.
C. Functional or performance is temporarily reduced or lost during the test, but requires operator intervention or system reset.
3. Basic performance: blank count: (1)RBC≤0.02×1012/L; (2)WBC≤0.2×109/L; (3)HGB≤1g/L; (4)PLT≤5×109/L.
● It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility information to

the customer or user.
● It is the user’s responsibility to ensure that a compatible electromagnetic environment for the equipment
can be maintained in order that the device will perform as intended.
● This product complies with the emission and immunity requirements of EN 61326-2-6 and EN 61326-1.
● This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may
F-1
User’s Manual
cause radio interference, in which case, you may need to take measures to mitigate the interference.
● Before using the equipment, the electromagnetic environment should be evaluated prior to operation of it.
● Do not use this equipment in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these can interfere with the proper operation.
F-2

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The User Manual is applicable to Automatic Hematology Analyzer (model: BCC-3900/BCC-3960) and all

Manufacturer: DIRUI INDUSTRIAL CO., LTD.

Place of Production: Changchun, China

Tel.: 400 811 6695 400 811 6605

Complaints Hotline: 0431-81935326 85177245

Date of Production: See the label.

Service Life: 7 years

Date of Compilation/ Revision: 07-2018.

● The Analyzer can only be used under a good grounded condition.

● The Analyzer shall not be used in a flammable and explosive environment.

● Do not touch the blood sample of patients directly.

● Disposable articles shall not be used repeatedly.

Dirui Company has the final interpretation right of the manual.

(2)Relevant electrical equipment complies with national standards.

(3)The Analyzer is operated according to the manual.

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

3.4 Reference value settings ................................................................................................................................. 3-3

5.4.3 QC list ............................................................................................................................................................................. 5-11

Chapter 6 Sample registration .......................................................................................................6-1

Chapter 9 System maintenance .....................................................................................................9-1

9.1 General ............................................................................................................................................................ 9-1

1.2 Normal operating conditions

1.3 Key indicators

WBC, NEU#, LYM#, MXD#, NEU%,

Measurement of Hemoglobin measurement with Hemoglobin measurement with

Impedance method is adopted for

Weight 25kg 25kg

1.4 Working principle

1.4.2.1 Whole-blood mode

Whole blood sample 6 μL

Sample of diluent ratio being about

Lyse 1 mL Diluent about 2.2 mL

WBC sample of diluent ratio being RBC/PLT sample of diluent ratio

Fig. 1-4-1 Dilution process of whole blood mode

20 μL peripheral blood sample

Sample of Diluent ratio being

Sample of Diluent ratio being

1 mL Lyse Diluent, about 2.2

WBC sample of Diluent ratio RBC/PLT sample of Diluent

Fig. 1-4-2 Dilution process of pre-dilution mode

Fig. 1-4-3 Counting principle diagram

(2)3-diff of white blood cell

1.4.5 Red blood cell/ platelet measurement

Fig. 1-4-4 Counting principle diagram

1.4.5.2 Red blood cell parameters

Fig. 1-4-5 Diagram

1.5 Structure of the Analyzer

1.5.1 Front view of the Analyzer

1 Front door 2 Display screen 3 Sample probe 4 Buttons 5 Printer cover

1.5.2 Rear view of the Analyzer

1.5.3 Left view of the Analyzer

1 Reagent door 2 Reagent door catch

1.6 External device of the Analyzer

The bar code reader is included in the standard configuration.

IN VITRO DIAGNOSTIC MEDICAL DEVICE

THE DEVICE MEETS THE REQUIREMENTS OF DIRECTIVE ON IN VITRO

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

CAUTION, REFER TO THE ACCOMPANYING FILES OR MARK DETAILED

Do not contact the sampling probe when the instrument is working.

Atmospheric pressure limitation

Caution, hot surface

2.1 Mounting requirements

2.3 Installation of the Analyzer

Total number of locations Current mode Test status

LYM#, MXD#, NEU# 109/L *. Default unit

1012/L . Default unit