BCC-3600 User Manual

Description
Thank you for purchase of BCC-3600 Hematology Analyzer. Before usage, please carefully read this User
Manual for correct usage. Please keep this User Manual properly for future reference.
Version number: REV. 07-2013.
Notes
● The Analyzer can only be used by professional medical laboratory personnel or the trained doctors, nurses or
lab assistants.
● The hospitals or inspection bodies adopting this Analyzer should prepare maintenance plan and maintain and
repair the Analyzer in strict accordance with the maintenance plan to avoid possible fault.
● All illustrations herein are only provided for demonstration and should not be applied for other purposes.
● Refer to the reagent operation instructions for the usage and storage. Ensure that the reagent has not yet
expired.
● Never use expired reagent. After opening, dusts, dirts and bacteria should be prevented from falling into the
reagent.
● Do not clean the dirts on the enclosure of Analyzer with mineral turpentine oil or benzene-containing solvent
that may change the color and shape of the enclosure. Wipe the enclosure with soft cloth or wet cloth. Clean
the heavy dirts with diluted cleaning agent or alcohol.
● When the outdoor temperature is fairly low in winter, put the Analyzer under room temperature for 24 hours
and then start up to test.
● User should comply with local or national regulations when discharging and disposing with reagent, waste
solution, waste sample and consumables.
● Pay attention that samples, QC materials, calibrating materials, waste liquids of potential biological
infections may irritate eyes, skins and mucosa. Users should obey the lab safety operation rules when
contacting relevant materials and wear personal protective equipment(e.g. protective clothing, gloves, etc.).
● Waste liquids and consumables should be correctly disposed subject to the regulations for medical wastes,
infectious wastes and industrial wastes. Particularly, the blood in waste liquid may have been polluted by
pathogen.
● Skin and eyes that in contact with reagent should be rinsed thoroughly with clean water. If necessary, seek
medical attention.
● Do not contact the sampling probes as the blood samples, QC materials and calibrating materials are of
potential biological infections. When aspirating samples with sampling probe, pay attention not to contact the
probe with the test tube wall that may cause blood splashing. Keep certain distance between the sampling
probe and the container bottom to ensure the accuracy of sucked liquid measure.
● Do not directly contact the blood preparation of patient.
● Do not use disposable goods for second time.

Warning
● The Hematology Analyzer should be provided with an independent power. Otherwise, the test results may be
influenced due to electromagnetic interference.
● Do not pull the electrical wire with wet hand in case of electric shock.
● Do not use broken wire or cable. Do not tread on, twist or drag the wire and cable. Otherwise fire may be
caused.
● The Analyzer should be operated in a good grounding condition.
● Confirm that input voltage is qualified. Use specified fuse box.
● Confirm that Analyzer switch is on [O] before power on.
● Do not use the Analyzer under inflammable and explosive conditions.
● Do not contact the moving parts to avoid accidents during test.
● When the host is powered on, no person are allowed to open the left, right doors and the upper cover except
the authorized maintainers.
● Be sure that the usage conditions meet the User Manual. Otherwise, the Analyzer may be out of normal
operation; the measurement results may be unreliable, even causing parts damages and personal injuries.
Statement
Dirui reserves the right of final interpretation of this User Manual.
Dirui shall be responsible for the safety, reliability and performance of this product only after the following
requirements are met:
● The initial installation, software upgrade and maintenance are taken by those approved by Dirui.
● Relevant electrical equipment are in line with national standards.
● The operations of Analyzer are in strict accordance with the specifications.
This User Manual is only intended for information provision and is subject to change without notice.
User Manual of Hematology Analyzer
Contents
Chapter 1 Introduction................................................................................................................... 1
1.1 General Description........................................................................................................................................ 1
1.2 Technical Specifications.................................................................................................................................. 1
1.3 Operating Principle.........................................................................................................................................2
1.3.1 Sample Aspiration...............................................................................................................................................................2
1.3.2 Sample Dilution.................................................................................................................................................................. 2
1.3.3 WBC/HGB Measurement...................................................................................................................................................4
1.3.4 WGB/PCT Measurement....................................................................................................................................................5
1.3.5 Rinsing.................................................................................................................................................................................7
1.4 Structure of the Analyzer............................................................................................................................... 7
1.4.1 Front View...........................................................................................................................................................................7
1.4.2 Rear View............................................................................................................................................................................8
1.5 External Equipment........................................................................................................................................8
1.6 Soft Keyboard.................................................................................................................................................. 8
1.7 Symbol.............................................................................................................................................................. 9
Chapter 2 Installation................................................................................................................... 10
2.1 Installation requirements............................................................................................................................. 10
2.1.1 Space Requirements..........................................................................................................................................................10
2.1.2 Power Requirements......................................................................................................................................................... 10
2.1.3 Environmental Requirements........................................................................................................................................... 10
2.2 Unpacking...................................................................................................................................................... 10
2.2.1 Unpacking Steps............................................................................................................................................................... 10
2.2.2 Transporting Method.........................................................................................................................................................11
2.3 Installation Steps........................................................................................................................................... 11
2.3.1 Dismantlement of Fixed Devices..................................................................................................................................... 11
2.3.2 Connection of External Pipelines..................................................................................................................................... 12
2.3.3 Installation of Printing Paper............................................................................................................................................13
2.3.4 Connection of Bar-code Scanner......................................................................................................................................13
2.3.5 Connection of Printer(Optional).......................................................................................................................................13
2.3.6 Connection with Computer Host......................................................................................................................................13
2.3.7 Initial Starting-up.............................................................................................................................................................. 14
Chapter 3 Setting........................................................................................................................... 15
3.1 General Description...................................................................................................................................... 15
3.2 Unit Set........................................................................................................................................................... 15
3.3 Reference Set..................................................................................................................................................18
3.3.1 Reference Category Set.................................................................................................................................................... 18
3.3.2 Reference Set.................................................................................................................................................................... 18
3.4 Abnormal Mark Set...................................................................................................................................... 19
I
3.5 QC Set................................................................................................................................................................20
3.5.1 L-J/Xbar QC.................................................................................................................................................................. 20
3.5.2 X-B QC..........................................................................................................................................................................20
3.6 Communication Set..........................................................................................................................................21
3.7 Printing Set....................................................................................................................................................... 22
3.8 Sleep Set.............................................................................................................................................................23
3.9 Auto Rinse Set...................................................................................................................................................24
3.10 Storage Amount Set....................................................................................................................................... 24
3.11 Department Set...............................................................................................................................................25
3.12 Expense Set..................................................................................................................................................... 26
3.13 Reagent Validity Set.......................................................................................................................................27
3.14 Data Format Set............................................................................................................................................. 27
3.15 Language Set.................................................................................................................................................. 28
Chapter 4 Calibration................................................................................................................... 30
4.1 Calibration Frequency.................................................................................................................................... 30
4.2 CalibrationMethod.......................................................................................................................................... 30
4.3 Calibrator Calibration.................................................................................................................................... 30
4.3.1 Calibration Edit............................................................................................................................................................. 31
4.3.2 Counting of Calibration.................................................................................................................................................31
4.3.3 Saving of Calibration Results........................................................................................................................................31
4.3.4 Deletion of Calibration Results..................................................................................................................................... 32
4.4 Fresh Blood Calibration..................................................................................................................................32
4.4.1 Preparation of Fresh Blood............................................................................................................................................32
4.4.2 Calibration Edit............................................................................................................................................................. 32
4.4.3 Counting of Calibration.................................................................................................................................................32
4.4.4 Saving of Calibration Results........................................................................................................................................33
4.4.5 Deletion of Calibration Results..................................................................................................................................... 33
4.5 Manual Calibration......................................................................................................................................... 33
4.6 Calibration Log................................................................................................................................................ 34
Chapter 5 QC(Quality Control)................................................................................................... 36
5.1 General Description.........................................................................................................................................36
5.2 L-J/X-Bar QC................................................................................................................................................... 36
5.2.1 QC Basic Set..................................................................................................................................................................36
5.2.2 QC Count.......................................................................................................................................................................38
5.2.3 QC Chart........................................................................................................................................................................39
5.2.4 QC List.......................................................................................................................................................................... 40
5.3 X-B QC.............................................................................................................................................................. 41
5.3.1 QC Parameter Set.......................................................................................................................................................... 42
5.3.2 QC Count.......................................................................................................................................................................42
5.3.3 QC Chart........................................................................................................................................................................43
II
5.3.4 QC List.............................................................................................................................................................................. 44
Chapter 6 Conventional Operation............................................................................................. 45

6.2 Preparations before Operation.................................................................................................................... 45
6.3 Start-up...........................................................................................................................................................45
6.4 Daily QC.........................................................................................................................................................46
6.5 Preparation of Samples.................................................................................................................................46
6.5.1 Whole Blood Sample........................................................................................................................................................ 46
6.5.2 Prediluted Sample(Peripheral Blood)...............................................................................................................................46
6.6 Sample Entry................................................................................................................................................. 47
6.6.1 Add Sample....................................................................................................................................................................... 47
6.6.2 Sample Delete................................................................................................................................................................... 50
6.7 Analysis of Whole Blood Sample................................................................................................................. 50
6.7.1 Mode Switch..................................................................................................................................................................... 50
6.7.2 Whole Blood Count.......................................................................................................................................................... 51
6.8 Analysis of Prediluted Sample..................................................................................................................... 51
6.8.1 Mode Switch..................................................................................................................................................................... 52
6.8.2 Prediluted Count............................................................................................................................................................... 52
6.9 Parameter Alarm...........................................................................................................................................53
6.9.1 Categories of Parameter Alarms.......................................................................................................................................53
6.9.2 Category or Form Abnormal Alarm................................................................................................................................. 53
6.10 Sleep..............................................................................................................................................................54
6.11 Rinse..............................................................................................................................................................54
6.12 Shut-down.................................................................................................................................................... 54
Chapter 7 Result Query................................................................................................................ 55
7.1.1 Graphic.............................................................................................................................................................................. 55
7.1.2 List.....................................................................................................................................................................................55
7.2 CV................................................................................................................................................................... 56
7.3 Deletion...........................................................................................................................................................58
7.4 Query.............................................................................................................................................................. 58
7.4.1 All Query........................................................................................................................................................................... 58
7.4.2 Condition Query................................................................................................................................................................58
7.5 Selection..........................................................................................................................................................60
7.6 Jump............................................................................................................................................................... 61
7.7 LIS...................................................................................................................................................................62
7.8 Print................................................................................................................................................................ 62
7.9 Data Backup...................................................................................................................................................62
7.10 Histogram Adjustment............................................................................................................................... 63
7.11 Data Adjustment..........................................................................................................................................65
III
Chapter 8 Maintenance.................................................................................................................66
8.2 Maintenance Guideline................................................................................................................................... 66
8.2.1 Regular Maintenance.....................................................................................................................................................66
8.2.2 Timely Maintenance...................................................................................................................................................... 67
8.3 Basic State......................................................................................................................................................... 67
8.4 Replace.............................................................................................................................................................. 67
8.5 Prime..................................................................................................................................................................68
8.6 Rinse...................................................................................................................................................................69
8.7 Maintenance......................................................................................................................................................70
8.7.1 Drain-off........................................................................................................................................................................ 71
8.7.2 Aperture......................................................................................................................................................................... 71
8.7.3 Soaking.......................................................................................................................................................................... 72
8.8 Reagent Registration....................................................................................................................................... 72
8.9 Device Detection............................................................................................................................................... 73
8.9.1 Motor Detection.............................................................................................................................................................73
8.9.2 Valve Detection............................................................................................................................................................. 73
8.9.3 Pump Detection............................................................................................................................................................. 74
8.10 HGB Check..................................................................................................................................................... 74
8.11 Counter............................................................................................................................................................ 74
8.12 Version Information.......................................................................................................................................75
8.13 Device Information........................................................................................................................................ 75
Chapter 9 Alarm Information and Processing........................................................................... 77
9.2 Alarm Information.......................................................................................................................................... 78
Chapter 10 Transportation and Storage..................................................................................... 80
10.1 Transportation Requirements...................................................................................................................... 80
10.2 Storage Requirements................................................................................................................................... 80
Appendix A Communication Interface Protocol V2.0...............................................................81
Appendix B Warranty................................................................................................................... 90
Appendix C Product Description.................................................................................................91
C.1 Product Categories..........................................................................................................................................91
C.2 Product Supporting Reagents....................................................................................................................... 91
C.3 Consumption of Product Supporting Reagents.......................................................................................... 91
C.4 Parameter Descriptions..................................................................................................................................91
IV
Chapter 1 Introduction
1.1 General Description

The BCC-3600 Hematology Analyzer is applicable for quantitative analysis of cell blood in medical lab and is
capable for classifying the white cell count into three parts and providing histograms of white blood cell, red
blood cell and platelet. The BCC-3600 Hematology Analyzer, designed and produced with the ideas of correct
measurement, convenient operation and low consumption, is of high integration and excellent performance,
and can meet various user requirements. The Analyzer can measure up to 21 parameters and display WBC,
RBC and PLT histograms. Furthermore, connection with bar-code scanner and outer printer is available via
USB screen and with computer via serial port.
The BCC-3600 Hematology Analyzer is an in vitro diagnostic medical device and a clinical inspection
instrument for screening for professional personnel. When making clinical judgment based on analytic results,
the doctors are required to refer to the clinical inspection results or other inspection results at the same time.
1.2 Technical Specifications

Sample size: Whole blood(venous blood)6 μL Pre-dilution(peripheral blood)20 μL
Diameter of gem hole: WBC hole: diameter 100 μm, hole depth 70 μm
RBC hole: diameter 70 μm, hole depth 65 μm
Wavelength of 540 nm
luminescent tube:
Test speed: 60pcs/h
Dilution ratio: Whole blood: WBC/HGB 1:504, RBC/PLT 1:21732
Peripheral blood: WBC/HGB 1:504, RBC/PLT 1:18389
Lyse volume: SLS:1mL
Testing items:
White blood cell WBC
Neutrophil count NEUT#
Lymph count LYM#
Mixed cell count MXD%
Neutrophils percentage NEUT%
Lymphoma percentage LYM%
Mixed cell percentage MXD%
Red blood cell RBC
Hemoglobin HGB
Mean corpuscular volume MCV
Mean corpuscular hemoglobin MCH
Mean corpuscular hemoglobin concentration MCHC
Red cell distribution width - coefficient of variation RDW-CV
Red cell distribution width - standard deviation RDW-SD
Hematocrit HCT
Platelet count PLT
Mean platelet volume MPV
Platelet distribution width PDW
Platelet hematocrit PCT
Platelet large cell ratio P-LCR
Platelet large cell count P-LCC
1
White blood cell histogram WBC Histogram

Red blood cell histogram RBC Histogram
Platelet histogram PLT Histogram
Storage volume: 10,000 pieces of testing records
L-J/ X-barQC: 12 documents, and each 30 records;
X-BQC: 1 document, and 150 records;
Languages: Chinese/English
External output: RS232 serial port
Bar code input: Bar-code scanner(standard configuration)
Power supply: 100-240V~ 50/60Hz
Fuse specification: 250V 4A
Power consumption: 70VA
Weight: 25kg
External dimension: 430mm(L)×395mm(W)×432mm(H)
1.3 Operating Principle

The Hematology Analyzer adopts the impedance platelet aggregometry to inspect the RBC, WBC, PLT and
volume distribution. Besides, it adopts the colorimetric method to measure the HGB and to calculate the other
parameter results.
1.3.1 Sample Aspiration
Under whole blood working mode, the users can directly send the whole blood sample to the Analyzer for
sampling. At this time, aspirate 6 μL whole blood sample.
Under pre-dilution working mode, the users should firstly mix the 20 μL peripheral blood sample and 0.7 mL
diluent to generate a dilution sample with dilution ratio of 1:36. After then, the user can send the diluted
sample to the Analyzer for sampling. At this time, the Analyzer will aspirate 0.216 mL diluted sample.
1.3.2 Sample Dilution
Generally, in the samples to be tested, various cells will overlap mutually, making the Analyzer unable to
correctly calculate the counts and the volume distributions of blood cells. Therefore, before counting or
calculating volume distribution, the samples should be firstly diluted to make the diluted blood cell pass the
inspection hole individually; at the same time, conductive environment should be provided for cell count and
volume measurement. In general, the number of red cells is 1,000 times more than the white cells. Therefore,
when counting the white cells, the disturbance from the red cells should be eliminated by adding the lyse into
the white cell diluted sample to dissolve the red cell membrane. Different working modes will be provided for
different samples, i.e.whole blood working mode and pre-dilution (peripheral blood) working mode.
2
Whole blood sample 6 μL
Diluent 2 mL
Sample of diluent ratio being about

1:334
Lyse 1 mL Diluent about 2.6 mL
WBC sample of diluent ratio being RBC/PLT sample of diluent ratio

about 1:504 being about 1:21,732
Fig.1-3-1 Diluent Process under Whole Blood Working Mode

As the above figure shows, under whole blood mode, the 6 μL whole blood sample aspirated by the Analyzer
is mixed with the 2 mL diluent to generate a diluted sample of about 1:334. The diluted sample will be divided
into two parts, of which 40 μL will be mixed with the 2.6 mL diluent again to form the 1:21732 count sample
for counting the RBC and the PLT; and the remaining will be mixed with the 1 mL lyse to form a 1:504 count
sample for counting the HGB and the WBC.
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.1-3-2 Diluent Process under Pre-diluent Working Mode

As the above figure shows, under the pre-diluent working mode, the 20 μL peripheral blood sample will mixed
with the 0.7 mL diluent(outside the Analyzer), to generate an about 1:36 pre-diluted sample. The Analyzer will
suck 0.216 mL pre-diluted sample and mix it with the 2 mL diluent to generate an about 1:334 pre-diluent
sample. The diluted sample will be divided into two parts, of which 40 μL will be mixed with the 2.2 mL
diluent again to form the 1:18389 count sample for counting the RBC and the PLT; and the remaining will be
mixed with the 1 mL lyse to form a 1:504 count sample for counting the HGB and the WBC.
3
1.3.3 WBC/HGB Measurement

1.3.3.1 Volume measurement
The Analyzer, through the sample volume passing through the hole during counting period by the injection
pump, can obtain the correct counting result in the quantitative sample. The quantitative injection pump
measures the samples passing through the inspection hole during each counting period, and the sample amount
will be decided by the operating step number of the motor.
1.3.3.2 WBC principles
The Analyzer adopts the impedance platelet aggregometry for WBC. When the sucked quantitative sample is
diluted by the quantitative conducting solution, it will be sent to the inspection unit of the Analyzer. The
inspection unit has one inspection hole, at the two sides of which is a pair of positive and negative electrodes
for connection with constant current power supply. Since the cell is a poor conductor, when the cells in the
diluted sample pass through the inspection hole, the direct current resistance between the electrodes will
change due to the constant negative pressure, so as to generate a pulse change proportionating to the cell
volume at the two sides of the electrode. When the cells pass through the hole in successive, a series of electric
pulses will be generated at the two sides of the electrode. The number of pulses will be the same as the number
of cells passing through the hole. And the pulse amplitude will be in direct proportion to the cell volume.
Compare the magnified electric pulse collected with the channel voltage range in corresponding to the normal
white cell voltage range to calculate the number of electric pulses in the white cell channel. Therefore, all
collected electric pulses will be classified by different channel voltage range. The WBC number will be the
number of electric pulses in the WBC channel. The number of cells in each channel subject to the pulse
voltage range will determine the volume distribution of cells.
Fig.1-3-4 Schematic Diagram for Counting

1.3.3.3 HGB measurement
The HGB will be measured by the colorimetric method. SLS-HGB method combining the oxygen radical
hemoglobin and cyano hemoglobin methods, is suitable for automatic inspection instrument since it has a fast
HGB converting speed and has no toxic materials.
The HGB will be measured by the SLS-HGB method. In the cuvette cell, when the diluted sample is added
with the lyse, the red cells will dissolve and release HGB. The HGB will generate HGB compound by
combining the lyse. At the end of the cuvette cell, the LED luminescent tube will send 540 nm monochromatic
light on the HGB compound solution. At the other end, the photo tube will receive the transmission light and
transfer the optical intensity signal into voltage signal after magnification. By comparing with the measured
voltage from the background transmitted light before the sample is added into the cuvette cell(only diluent
remains in the cuvette cell)the sample HGB will be obtained(unit: g/L). The result will be displayed in the
analytic result area on the counting screen.
Background transmission intensity
HGB  Constant  Log10
Sample transmission intensity
1.3.3.4 White cell parameters
(1)WBC
The Analyzer obtains theWBC(109/L)by direct measurement of number of electric pulses corresponding to the
4
white blood cell.

WBC  n  109 / L
(2)Classification of white blood cell
Based on the principle of electrical impedance, when cells of different volumes pass through the small hole,
the pulses are also different. And different white blood cells have distinctive volumes after mixed with the lyse.
Therefore, the white blood cells in the blood can be artificially divided into three categories, including LYM,
MXD and NEUT based on the pulse sizes.
(3)WBC Histogram
The Analyzer will provide the WBC Histogram while giving the WBC result. In the WBC Histogram, the
horizontal axis is the volume of white blood cell(unit: fL)and the vertical axis is the relative quantity of white
blood cells(unit: 109/L). After each counting, the WBC Histogram can be seen directly in the analytic result
area of the counting screen or by entry into the inquiry screen.
1.3.3.5 HGB parameters
The unit of HGB is g/L.
Background transmission intensity
HGB  Constant  Log10
Sample transmission intensity
1.3.4 WGB/PCT Measurement
1.3.4.1 Principle of volume quantization
The Analyzer, through the sample volume passing through the hole during counting period by the injection
pump, can obtain the correct counting result in the quantitative sample. The quantitative injection pump
measures the samples passing through the inspection hole during each counting period, and the sample amount
will be decided by the operating step number of the motor.
1.3.4.2 Principles of WGB/PCT
The Analyzer adopts the impedance platelet aggregometry for WGB/PCT. When the sucked quantitative
sample is diluted by the quantitative conducting solution, it will be sent to the inspection unit of the Analyzer.
The inspection unit has one inspection hole, at the two sides of which is a pair of positive and negative
electrodes for connection with constant current power supply. Since the cell is a poor conductor, when the cells
in the diluted sample pass through the inspection hole, the direct current resistance between the electrodes will
change due to the constant negative pressure, so as to generate a pulse change proportionating to the cell
volume at the two sides of the electrode. When the cells pass through the hole in successive, a series of electric
pulses will be generated at the two sides of the electrode. The number of pulses will be the same as the number
of cells passing through the hole. And the pulse amplitude will be in direct proportion to the cell volume.
Compare the magnified electric pulse collected with the channel voltage threshold in corresponding to the
normal red blood cell/platelet volume to calculate the number of electric pulses in the red blood cell/platelet
channel. Therefore, all collected electric pulses will be classified by different channel voltage thresholds. The
WGB/PCT will be the number of electric pulses in the WGB/PCT channel. The number of cells in each
channel subject to the pulse voltage range will determine the volume distribution of cells.
Fig.1-3-5 Schematic Diagram for Counting
5
1.3.4.3 Red cell parameters

(1)RBC
The Analyzer obtains the RBC(1012/L)by direct measurement of number of electric pulses corresponding to the
red blood cell.
RBC  n  1012 / L
(2)MCV
Calculate the MCV(unit: fL)based on the RBC Histogram.
(3)HCT, MCH and MCHC
Calculate the HCT(unit: %), MCH(unit: pg)and MCHC(unit: g/L)subject to the following formula.
RBC  MCV
HCT 
Hematocrit 10
HGB
MCH 
Mean corpuscular hemoglobin RBC
HGB
MCHC   100
Mean corpuscular hemoglobin concentration HCT
Where:
The unit of RBC is 1012/L;
The unit of MCV is fL;
The unit of HGB is g/L.
(4)RDW-CV
The RDW-CV is available via the RBC Histogram. The RDW-CV means the coefficient of variation of
volume distribution by percentage.
(5)RDW-SD
The RDW-SD means the histogram width corresponding to 20% of the RBC Histogram(unit: fL), as Fig.1-3-6
shown:
Fig. 1-3-6
(6)RBC Histogram
While giving the RBC result, this Analyzer will provide the volume distribution diagram of red cell, referring
to RBC Histogram, which illustrates the distribution of cell colony. In the RBC Histogram, the horizontal axis
is the volume of red blood cell(unit: fL)and the vertical axis is the relative quantity of red blood cells(unit:
1012/L). After each counting, the RBC Histogram can be seen directly in the analytic result area of the counting
screen or by entry into the inquiry screen.
1.3.4.4 PLT parameters
(1)PLT
The Analyzer obtains the PLC(unit: 109/L)by direct measurement of number of electric pulses corresponding
to the platelets.
PLT  n  109 / L
6
(2)MPV
Calculate the MCV(unit: fL)based on the PLT Histogram.
(3)PDW
The PDW is available via the PLT Histogram, which is the geometric standard deviation(10GSD)of the
platelet volume distribution.
(4)PCT
The PCT(unit: %)can be calculated based on the following formula. Where, the unit of PLT is 109/L, and the
unit of MPV is fL.
PLT  MPV
PCT 
10000
(5)P-LCR
The P-LCR is available via the PLT Histogram, which is the proportion of P-LCC in the PLT.
(6)PLT Histogram
While giving the PLT result, this Analyzer will provide the volume distribution diagram of platelet, referring
to PLT Histogram, which illustrates the distribution of cell colony. In the PLT Histogram, the horizontal axis
is the volume of platelet(unit: fL)and the vertical axis is the relative quantity of platelets(unit: 109/L). After
each counting, the PLT Histogram can be seen directly in the analytic result area of the counting screen or by
entry into the inquiry screen.
1.3.5 Rinsing
The Analyzer automatically rinses all parts where samples flow through in every count period and ensure no
sample residues in the liquid pipelines.
(1)Rinse the inner part and outer part of the sampling probe with the diluent.
(2)Rinse the count pool with the diluent.
1.4 Structure of the Analyzer

The Analyzer consists of mechanical movement, liquid pipeline, electric control and software system.
1.4.1 Front View
1 Touch screen 2 Printer 3 Biological hazards identification

4 Count button 5 Sampling probe
Fig.1-4-1 Front View
7
1.4.2 Rear View
1 Upper cover plate 2 Right door components 3 Power switch 4 Power socket
5 Liquid level sensor screen for diluent 6 Liquid level sensor screen for lyse
7 Waste liquid joint 8 Diluent joint 9 Lyse joint 10 Cleaning solution joint
11 USB screen 12 Serial communication port 13 Left door components 14 Back panel
Fig.1-4-2 Rear View
1.5 External Equipment

Printer: the Analyzer can be connected to the external laser printer. The Automatic Hematology Analyzer
supports the following two series of printers:
(1)HP LaserJet P1007; and
(2)HP LaserJet P2055 Series.
Bar-code scanner: to be connected directly with the Analyzer for fast input of bar code information.
Notes:
The printers are optional and the bar-code scanner is standard configuration.
1.6 Soft Keyboard

Call out the soft keyboard by clicking the edit box. Input relevant contents in the edit box as necessary. Click
“Enter” button to close the soft keyboard:
Fig. 1-6-1
8
0~9: input figurers.

a~z: input characters.
“EN” button: switch between Chinese/English input method.
“Enter” button: confirmation of input.
1.7 Symbol
Symbol Meaning
To perform as the instructions under the mark, or biological infection may be caused.
Alternating current
Only for “In Vitro Diagnostic” use
Storage temperature
Lot number
Valid date
Serial number
Measurement Control
Production date
Earthing mark
Manufacturer
Instrument conforms to the in vitro diagnosis device directive of EU
Refer to the accompanying documents
Category number
Do not contact the sampling probe when the Analyzer is working.
Above signs are included on the Analyzer, reagent, control and reference material.
9
Chapter 2 Installation
2.1 Installation requirements

To ensure normal operation, the BCC-3600 Hematology Analyzer should be installed by those authorized by
Dirui during delivery.
Following requirements on space, power supply and environment must be guaranteed before operation. The
Analyzer should be placed on the horizontal bench.
2.1.1 Space Requirements
The space of Analyzer for maintenance and repair should meet the following requirements:
(1)The distance between either side and wall should not be less than 50 cm.
(2)The distance between the rear panel and wall should not be less than 50 cm.
(3)The distance between the front of the Analyzer and other instruments should not be less than 100 cm.
(4)Sufficient spaces should be left on the operating bench or under the Analyzer for diluent, lyse, cleaning
agent and waste liquid collecting device.
2.1.2 Power Requirements
(1)Power supply: 100-240V~ 50/60Hz
(2)Power: 70VA
(3)Fuse box: 250V 4A
● The Analyzer should be applied under good earthing conditions and should not share the same socket
with such large-load appliances as air-conditioner, refrigerator and oven.
● Ensure that the input voltage meets the Analyzer requirements.
2.1.3 Environmental Requirements
(1)Normal working temperature range:18°C~30°C.
(2)Normal working humidity range: not more than 80%.
(3)Atmospheric pressure 75 kPa ~106 kPa.
(4)The operating environment should be free of dust, mechanical vibration, big noise and power interference.
(5)It is suggested to evaluate the electromagnetic environment in the lab before operating the Analyzer.
(6)Do not leave the Analyzer closer to the strong electromagnetic interference source that may interfere the
normal operation of equipment.
(7)Do not leave the Analyzer closer to the brush-type motor, flashing fluorescent lamp and electric
contract-type equipment requiring frequent switching on/off.
(8)Keep the Analyzer away from direct sun exposure or before hot source and air source.
(9)Keep the Analyzer at well-ventilated place.
Any non-conforming environment or power supply may influence accuracy and precision of
measurement, damage the instrument or lead to personal injury.
2.2 Unpacking
2.2.1 Unpacking Steps
Upon arrival of the Analyzer, please check the package for intactness. In case of any physical damage, please
contact Dirui or local agents. Please unpack the case by following the steps below if no physical damage is
found:
(1)Keep the package case upright and ensure that the arrow is upward.
(2)Unpack the case and take out the accessory case and then check them with packing list to see whether any
10
component is missing or not. If any component is missing, please contact Dirui or local agents.
2.2.2 Transporting Method
(1)Ensure that the used Analyzer has gone through “Pipeline packaging and draining” before transport.
(2)Utility cart and the like are available for smooth and short-distance transport.
(3)When moving and transporting, prevent the display on the front panel and the sampling probe from being
applied with external force, contacting other goods and damaging.
(4)When moving and transporting, always keep the Analyzer upright. Inclination and side laying are not
allowed.
(5)During transport, avoid vibration as far as possible. After transport, examine and debug the Analyzer before
usage.
2.3 Installation Steps

The Analyzer should be installed by professional person of Dirui. Do not dismantle and reinstall the Analyzer
except for normal maintenance.
2.3.1 Dismantlement of Fixed Devices
During transport, the sampling probe is fixed by nylon cable ties for protection. Before powering on for usage,
take out the nylon cable ties firstly in accordance with the following steps:
(1)Open the right door.
(2)Cut off the red nylon cable ties 1 and 2 with diagonal plier or scissors and take them out. See the figure
below for detailed positions:
Nylon cable
tie 1
Fig. 2-3-2
11
Nylon cable
tie 2
Fig.2-3-3
2.3.2 Connection of External Pipelines
Fig.2-3-1
Before connecting the pipelines, first take out the sealing films on 7, 8, 9 and 10 as shown in Fig. 2-3-1.
(1)Connection of cleaning solution component
a)Take out the BCC-series probe cleaning solution bottle(500mL)and place it on the operating bench at the
rear of the Analyzer;
b)Take out the cleaning solution component from the accessory case and connect the tubes with the
component 10 shown in Fig.2-3-1;
c)Open the bottle cover and place the other end of the cleaning solution component in the bottle.
(2)Connection of lyse component
a)Take out the BCC-series lyse bottle(500mL)and place it on the operating bench at the rear of the
12
Analyzer;
b)Take out the F1 line(connecting line of liquid level sensor of lyse)from the accessory case and lyse
component;
c)Connect one end of the F1 line with the joint in the lyse component;
d)Insert the end with connecting tube and floater into the solution bottle;
e)Insert the aviation plug at the other end of theF1 line with the component 6 as shown in Fig.2-3-1; and
connect the connecting tube of lyse component with the component 9 as shown in Fig.2-3-1.
(3)Connection of diluent component
a)Take out the diluent barrel in the packing box and place it below the operating bench;
b)Take out the F2 line(connecting line of liquid level sensor of diluent)from the accessory case and diluent
component;
c)Connect one end of the F2 line with the joint in the diluent component;
d)Insert the end with connecting tube and floater into the diluent bottle; and
e)Insert the other end of the F2 linewith the component 5 as shown in Fig.2-3-1; and connect the connecting
tube of diluent component with the component 8 as shown in Fig.2-3-1.
(4)Connection of waste liquid pipeline
a)Place the waste liquid barrel under the operating bench;
b)Take out the waste liquid pipeline in the accessory case, and connect one end of the waste liquid pipeline
with the component 7 as shown in Fig.2-3-1, and insert the other end in the waste liquid barrel.
Please confirm to the related local regulations on medical waste disposal.

2.3.3 Installation of Printing Paper
(1)Select the thermal printing paper roll of 57 mm width and diameter less than 50 mm;
(2)Open the printer cover;
(3)Put the printing paper into the printing paper cassette and make the paper-out end close to the inner side of
the instrument;
(4)Insert the end of the printing paper to the bottom of the scroll bar. When the scroll bar rolls, the printing
paper will automatically pass through the scroll bar; and
(5)Pass the paper through the paper exit and close the printer cover.
2.3.4 Connection of Bar-code Scanner
Connect the accompanying connecting wire with the “USB” port in the Analyzer(any “USB” port will be OK).
When the system is working, do not look directly at the light beam from the bar-code scanner that may
hurt your eyes.
2.3.5 Connection of Printer(Optional)
Correctly connect the printer and the “USB” port of Analyzer via the data line. And check the specification of
printing paper.
Insert one end of the power line of printer into the power outlet of the printer and the other end into the socket.
2.3.6 Connection with Computer Host
Correctly connect the accompanying serial port of the Analyzer(component 12 as shown in Fig.2-3-1)with the
serial port on the computer host and confirm connection.
Ensure reliable earthing of socket connected with the power line.
13
2.3.7 Initial Starting-up

(1)Connection of power line
Take out the power line from the accessory case, and insert one end into the power socket(component 4 as
shown in Fig.2-3-1)and the other end into the power socket.
(2)Turn the power switch on, and the screen displays“System Loading…”. The Analyzer will go through
initialization of configuration file, mechanical resetting, self-inspection, pipeline cleaning and blank test for
about 3-5 minutes. After then, click “Exit”button to enter into the“Count”screen.
During starting, the Analyzer will automatically go through Background detection , the result of which will be
displayed on the “Blank Detection” screen.
● Background detection means to replace the sample with the dilution for counting.
● The analytic results in case of background detection abnormity may be unreliable.
Any fault during initialization will be displayed on the screen. The users should not proceed to the next
operation unless the fault is settled. See 9.2 Alarm Message for fault settlement method.
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Chapter 3 Setting

The systematic parameters of the Automatic Hematology Analyzer have been initialized when delivered from
the factory. The screen displayed in initial starting-up will be default. The users may reset the parameters to
meet different requirements in practical application.
Setting for each item will be introduced in the displaying order under this Chapter.
In the “Count” screen, press the “Page on”button and then the “Set” button for setting of related parameters.
Notes:
In each setting under this Chapter, “○” means unchecked and “▪” means checked. Click the unchecked
item to turn it into checked one.
3.2 Unit Set

Click “Unit” button for the unit setting of testing unit, as the figure shown:
Fig. 3-2-1
Click “ ” button at the back of each testing item and select different testing unit in the drop-down list subject
to actual requirements. When the unit is accidentally changed, click “Default” button for restoring factory
setting. See the figure for prompt:
Fig.3-2-2
15
Click “OK” button and the screen prompts “Successful Restoring of Defaults”; and click “Cancel” button for
canceling.
Under each testing items, several units are available for selection(Dimmed items are unchangeable, including
LYM#, MXD#, NEUT#, P_LCC). See Table 3-2-1 for detailed unit setting:
16
Table3-2-1
Testing items Unit Numeric form Remarks
10^9/L ***.** Default unit
10^2/μL ***.**
WBC
10^3/μL ****.*
/nL ***.**
LYM#, MXD#, NEUT# 10^9/L ***.** Default unit
LYM%, MXD%, NEUT% % **.* Default unit
10^12/L **.** Default unit
/pL **.**
RBC
10^4/ μL ****
10^6/μL **.**
g/L *** Default unit
HGB g/dL **.*
mmol/L **.*
fL ***.* Default unit

MCV,RDW-SD
μm^3 ***.*
pg **.* Default unit

MCH
fmol ***
g/L *** Default unit
MCHC g/dL ***.*
mmol/L ***.*
RDW-CV % **.* Default unit
L/L **.* Default unit

HCT
% *.***
10^9/L **** Default unit
10^3/μL ****
PLT
10^4/μL ***.*
/nL ****
fL **.* Default unit

MPV
μm^3 ***.*
PDW fL **.* Default unit
% .*** Default unit

PCT
mL/L *.**
P-LCR % **.** Default unit
P-LCC 10^9/μL **.** Default unit
17
When the unit of testing item is changed, the numeric form of the testing result will also be changed.
3.3 Reference Set

Click “Reference” button on the “Set” screen to set the upper limit and lower limit of each testing button, as
shown in the figure:
Fig. 3-3-1
3.3.1 Reference Category Set

Click the “Common” or “ ” to set the category of reference. The category includes common, adult male, adult
female, child, newborn and 5 self-defined reference(defaulted as 1-5)and the default category is “Common”.
Each lab should select suitable reference category and set suitable reference interval subject to actual sample
condition.
3.3.2 Reference Set
Click the input boxes corresponding to the upper limit and lower limit of each testing item and input the upper
limit and lower limit via the soft keyboard and press the “Enter” button, and the setting will be successful.
If the input lower limit of the reference is lower than the upper limit or the input reference falls outside the
setting range of the program, the system will automatically recover the reference to the value before change
and will require recheck before inputting again.
When the reference is accidentally changed, click “Default” button for restoring factory setting. See the figure
for prompt:
Fig.3-3-2
18
Click “OK” button and the screen prompts “Successful Restoring of Defaults”; and click “Cancel” button for
canceling.
3.4 Abnormal Mark Set

Click the “Abnormal Mark” on the “Set” screen for the relevant setting of abnormal mark.
Click “RBC/PLT” button and the screen displays as follows:
Fig. 3-4-1
Click “WBC” button and the screen displays as follows:
Fig. 3-4-2
On the above screen, such prompt ranges of RBC/PLT and WBC abnormal alarms can be set. Input the setting
value via the soft keyboard. Click “Enter” button, and the setting will be successful.
When the reference is accidentally changed, click “Default” button for restoring factory setting. Click the
19
“Default” button and the screen prompts “The current value will be lost, continue or not?”. Click “OK” button
and the screen prompts “Successful Restoring of Defaults”; and click “Cancel” button for canceling.
3.5 QC Set
Click the “QC” button on the “Set” screen for the relevant setting of QC.
3.5.1 L-J/Xbar QC
Click “L-J/Xbar” button and the screen will display as follows:
Fig. 3-5-1
3.5.1.1 QC method
The QC method is divided into L-J and X bar.
3.5.1.2 Calculation method
There are two calculation methods for QC deviation limit: absolute value and percentage.
3.5.1.3 Range
When checking the “Absolute Value” in the calculating method, there are two ranges for calculating the QC
deviations, including 2SD and 3SD.
When checking the “Percentage” in the calculating method, there are two ranges for calculating the QC
deviations, including 2CV and 3CV.
3.5.1.4 Saving of invalid data
When selecting “Save”, the invalid QC data will be saved in the QC records.
When selecting “Not Save”, the invalid QC data will not be saved in the QC records.
Invalid data refer to the WBC, RBC, HGB and PLT data that fall beyond the effective range.
3.5.2 X-B QC
Click “X-B” button and the screen displays as follows:
20
Fig. 3-5-2
Starting-up of X-BQC: click the X-B switch for turning on and off
X-B setting: When calculating the number of selectable samples of every X-BQC point for each time, the
selectable range is from 20 to 200 and the recommended number is 20. Click “Sample Num/Group” input box
and input the setting figure via the soft keyboard. Press “Enter” button, and the setting will be successful.
3.6 Communication Set

Click “Communication” button on the “Set” screen for setting of auto communication, as the figure shown
below:
Fig. 3-6-1
The user may select the auto communication or not according to actual needs. If “Yes” is selected, the auto
communication will be on. And the Analyzer will send the analytic results to the outer computer; if “No” is
21
selected, the auto communication will be off. And the analytic results will be transferred manually.
3.7 Printing Set

Click “Print” button on the “Set” screen for relevant printing setting, as the figure shows below:
Fig. 3-7-1
(1)Setting of auto print
The auto print can be set as “On” or “Off” status:
a)On:the printer will automatically print the analytic print. Inner printer or outer printer will be decided by
the setting of printer type.
b)Off:the analytic results will be printed manually.
(2)Setting of printer type
The printer type is divided into “Inner Printer” and “Outer Printer”:
a)Inner printer: the report will be printed by the inner printer;
b)Outer printer: the report will be printed by the outer printer.
(3)Setting of inner printer
a)If “Inner Printer” is selected, the printing direction may be selected as Horizontal or Vertical.
 Horizontal:the report will be printed horizontally.
 Vertical:the report will be printed vertically.
b)If the “Inner Printer” is selected, when clicking the “Printer Test” button, the “print test ok!” will be
printed. If no short line or broken character is found, the printer is deemed as normal.
(4)Setting of outer printer
If the “Outer Printe” is selected, the user may set the printer model, template, paper and title, as the figure
shows below: User 2013-09-03 09:06
删除的内容:
22
Fig. 3-7-2
3.8 Sleep Set

Click “Page Up or Page Down” button on the “Set” screen. And the screen prompts to proceed to the next page.
Click “Sleep” button for relevant setting, as the figure shows below:
Fig. 3-8-1
(1)Instrument sleep
Click the time input box and input the figure via the soft keyboard(input range is from 60 to 120 and the unit is
minute). Click “Enter” button, and the setting will be successful. If 60 is input, the instrument will enter into
“sleep” status when no action is made within 60 minutes. The screen bottom prompts “System Sleep”.Press
count button for waking up for second use.
(2)Screen sleep
23
Click the time input box and input the figure via the soft keyboard(input range is from 10 to 30 and the unit is
minute). Click “Enter” button, and the setting will be successful. If 20 is input, the instrument will enter into
“sleep” status when no action is made within 20 minutes(the screen becomes blank screen). Click any position
on the screen for waking up for second use.
If “Sleep” is made to both the instrument and the screen, when waking up the instrument by “Count” button,
the screen will also be waken up.
3.9 Auto Rinse Set

Click “Page Up or Page Down” button on “Set” screen, and it will enter into next page. Click “Auto Rinse”
button, and relevant Setting of auto rinse can be selected, as shown in the figure below:
Fig. 3-9-1
Click input box of Count Times, input No. via soft keyboard(input range is from 10 to 200), and press “Enter”
button, the setting will be successful. If input No. is 200, after the test of every 200 samples, the Analyzer will
have an auto rinse. The count times in Analyzer will be reset automatically after the rinse.
The count times is 50 when it leaves the factory.
3.10 Storage Amount Set

Click “Page Up or Page Down” button on “Set” screen, and it will enter into next page. Click “Storage”, and
relevant Setting of amount of data storage can be selected, as shown in the figure below:
24
Fig. 3-10-1
Select amount of data storage in drop-down list, and storage depth is 500, 1000, 2000, 5000, and 10000
respectively.
If amount of data storage exceeds the data that has been stored in device, the system will prompt “Saving
complete!” and the data will be stored as set.
If amount of data storage is less than the data that has been stored in device, it will prompt as follows:
Fig. 3-10-2
Select “OK” button, and the system will cancel previous data exceeding storage amount based on the order of
test time. Select “Cancel” button, the system will set the current data amount stored in the device as the
maximum storage amount.
Data storage amount is 2000 when it leaves the factory.
3.11 Department Set

Click “Page Up or Page Down” button on “Set” screen, and it will enter into next page. Click “Department”
button, and relevant Setting of department can be selected, as shown in the figure below:
25
Fig. 3-11-1
Add: click “Add”, and soft keyboard will pop up. Input information, click “Enter” button and new information
of department will be added successfully;
Delete: select information of a certain line, and click“Delete”button, the screen will prompt “Do you want to
delete the current line?” , click “OK” button, and the selected record will be deleted; Click “Cancel” button,
and the record will not be deleted.
Alter: Click selected information line, re-click the information, and soft keyboard will pop up. After the
information is put in, click “Enter” button to save the altered department information.
3.12 Expense Set

Click “Page Up or Page Down” button on “Set” screen, and it will enter into next page. Click “Expense”
button, and relevant Setting of expense can be selected, as shown in the figure below:
Fig. 3-12-1
26
Add: click “Add” button, and soft keyboard will pop up. Input information, click “Enter” button and new
expense will be added successfully;
Delete: select information of a certain line, and click “Delete” button, the screen will prompt “Do you want to
delete the current line?”, click “OK” button, and the selected information will be deleted; click “Cancel”
button , and the record will not be deleted.
Alter: Click selected information line, re-click the information, and soft keyboard will pop up. After the
information is put in, click “Enter” button to save the altered expense information.
3.13 Reagent Validity Set

Click “Page Up or Page Down” button on “Set” screen, and it will enter into next page. Click “Reagent
Validity” button, and relevant Setting of reagent validity can be selected, as shown in the figure below:
Fig. 3-13-1
Click date input box behind the corresponding item, input based on the period of validity noted in
corresponding reagent instruction via soft keyboard, and press “Enter”, button and reagent validity will be set
successfully.
Users can click “□” button before the period of validity, it will change into “ ”, if the reagent is beyond the
period of validity, the dialog box will pop up, and the warning of expiration of reagent will be indicated.
● The period of reagent shall be reset, when the Analyzer is used for the first time or when diluent, lyse
and cleaning solution of different batch are removed.
● Expired diluent, lyse and cleaning solution are not allowed to use, otherwise, the accuracy of test
results will be affected.
3.14 Data Format Set

Click “Page Up or Page Down” button on “Set” screen, and it will enter into next page. Click “Data Format”
button, and relevant Setting of data format can be selected, as shown in the figure below:
27
Fig. 3-14-1
There are 3 types of data format to be selected:
(1)YYYY-MM-DD: year-month-date;
(2)DD-MM-YYYY: date-month-year;
(3)MM-DD-YYYY: month-date-year;
Users can select date format based on actual needs.
Altered date format will be displayed in the position of indicating time(e.g. inspection time, sampling
time, etc.).
3.15 Language Set

Click “Language” button as shown in the above figure, and language setting can be conducted as shown in the
figure below:
28
Fig. 3-15-1
There are two languages (Chinese and English) in the software. Click and select the language to be used in the
software, and the screen language will be altered.
29
Chapter 4 Calibration
4.1 Calibration Frequency

The purpose of calibration for Analyzer is to ensure the accuracy of the analysis results. The calibration of
Analyzer has been conducted before it leaves the factory. Under the following three conditions, operators still
shall conduct calibration for the Analyzer:
(1)Before the first-time-use;
(2)After the main components are removed;
(3)Obvious deviations are found in system when operating quality control.
Measured data can be used as effective data only after the calibration of Analyzer is conducted.
4.2 CalibrationMethod
Three methods are provided in the Analyzer: manual calibration, calibrator calibration and fresh blood
calibration.
In the calibration of calibrator and fresh blood, the No. count relevant with calibration can be automatically
conducted by Analyzer. Calibration coefficient obtained after the calibration can be saved in “Manual
Calibration” screen.
Preparation before calibration: the examination shall be conducted based on following steps. Do not calibrate it
when problems are found. Operators shall find the reason, and decide to calibrate it or not after problems are
solved. If the problems can not be solved, please contact the After-sale Department of Dirui.
(1)Exam the reagent that will be used by the Analyzer to ensure the reagent volume is sufficient for the whole
calibration process. If reagent is used up in calibration process, re-calibration is required.
(2)When implementing ground calibration, if the measured value in the screen exceeds the ground range, it
shall be handled referring to warning information in 9.2 to ensure the ground calibration results meet
requirements.
Used calibrator and reagent shall be specified by Dirui, and the calibration shall be conducted based on
the operating instructions of calibrator and reagent.
4.3 Calibrator Calibration
The calibration for calibrating materials should be conducted under the “Whole Blood” measurement
mode.
Click “Calibration” in main menu list and select “Calibration for Calibrating Materials”, as shown in the figure
below:
30
Fig. 4-3-1
4.3.1 Calibration Edit

Click corresponding line of the “Reference”, input reference of each parameter(See Instruction for Use of
Calibrating Materials for details) via soft keyboard.
4.3.2 Counting of Calibration
The operator should prepare the calibrating material and finish the calibration in accordance with the following
steps:
(1)Confirm that the working mode is “Whole Blood”.
(2)Put test tube containing with blended calibrating materials under sampling probe to make sampling probe
aspirate the sample.
(3)Press the “Count” button, and the sampling probe will automatically suck in the calibrating material. After
the sampling probe is raised, operator can move the test tube away, and sampling probe will add the aspirated
calibrating materials into count pool. The Analyzer will perform calibration counting process and the screen
bottom will display“Counting…”, “Data Processing…”.
(4)After the completion of analysis, the sampling probe is reset for the preparation of next calibration count
and results obtained after the count will be shown on the screen.
4.3.3 Saving of Calibration Results
If the counting result is beyond the lower limit of the Analyzer software, the screen will pop up “Invalid Data”.
Click “OK” button to automatically clear up this counting result. Only valid counting result will be displayed
on the calibration screen.
After 3 or more effective count results are obtained, Analyzer will automatically calculate the CV value,
average and calibration factor.
When 3 or more effective count results are obtained and after the click of “save”, if calibration factor of some
references is not within 75% to 125%, it will prompt “Saving failed, calibration factor shall be within 75% to
125%”. Operator shall check whether the reference input is correct. If the reference input is correct, abnormal
calibration results shall be deleted and calibration count shall be re-conducted.
Calibration factor=manual calibration factor*calibration factor in calibration screen of calibrating

material.
It is suggested to obtain a group of calibration factors after 5 times of counting. Click “Save” button and the
31
screen will prompt “Saving complete”. After the click of “OK” button, calibration factor will be automatically
stored in calibration factor list of “Manual Calibration” screen.
4.3.4 Deletion of Calibration Results
After the test, if the count result of a certain time deviates a lot from the last time, and it is affirmed as invalid
value, select the corresponding line of the result and click “Delete” button, the count result will be deleted
permanently.
Calibration factor of calibrator can not be deleted.
4.4 Fresh Blood Calibration
Calibrator calibration shall be conducted under the “Whole Blood” measurement model.
4.4.1 Preparation of Fresh Blood
(1)Use EDTA- K2(1.5~2.2 mg/mL blood)anticoagulation vacuum tube to collect venous blood.
(2)Quickly mix the venous blood in the tube with the anticoagulation.
(3)Prepare 3~5 samples of normal and fresh blood based on the above method.
4.4.2 Calibration Edit
Click “Calibration” button in main menu list and select “Fresh Blood” button, as shown in the figure below:
Fig. 4-4-1
(1)Test prepared fresh blood by reference device for 3 times, deem calculated average value as reference and
input it into the line of each reference.
(2)Select the No. of fresh blood in the drop-down list behind “Sampling No.” before the test, and test 5 times
for each fresh blood. “Sampling No.” shall be re-selected when the next sample is tested.
4.4.3 Counting of Calibration
The operator should prepare the calibrating material and finish the calibration in accordance with the following
steps:
(1)Confirm that the working mode is“Whole Blood”.
(2)Put test tube containing with blending calibrator under sampling probe to make sampling probe aspirate the
32
sample.
(3)Press the “Count” button, and the sampling probe will automatically suck in the calibrating material. After
lifting the sampling probe, operator can remove the tube and sampling probe will put aspirated fresh blood into
the count pool. The Analyzer will perform calibration counting process and the screen bottom will
display“Counting…”, “Data Processing…”.
4.4.4 Saving of Calibration Results
If the counting result exceeds the lower limit of the Analyzer software, the screen will pop up “Invalid Data”.
Click “OK” button to automatically clear up this counting result. Only valid counting result will be displayed
on the calibration screen.
Results of each fresh blood tested for 5 times can be indicated in the blank of result 1 to 5 respectively, and the
CV, average value, calibration factor of the results for 5 times, indicating in the above part of the table;
calibration factor, meanwhile, indicates in the factor 1 of the bottom part in the table; when another sample is
tested, results will be shown in above part, meanwhile, calibration factor will be shown in factor 2.
After Analyzer obtains 3 or more than 3 factors, calibration factor will be calculated automatically.
When more than 3 count results are obtained, if calibration factor of some reference is not within 75% to 125%,
it will prompt “Saving failed, calibration factor shall be within 75% to 125%”. Operators shall exam whether
the reference input is correct. If the reference input is correct, calibration results shall be deleted and
calibration count shall be re-conducted.
Calibration factor=manual calibration factor*calibration factor in fresh blood calibration screen.

It is suggested to obtain a group of calibration factors after 5 times of counting. Click “Save” button and the
screen will prompt “Saving complete”. After the click of “OK”, calibration factor will be automatically stored
in calibration factor of “Manual Calibration” screen.
4.4.5 Deletion of Calibration Results
After the test, if the count result of a certain time deviates a lot from the last time, and it is affirmed as invalid
value, select the corresponding line of the result and click “Delete”, the count result can be deleted
permanently.
Fresh blood calibration factor can also be deleted and if the factor is deleted, all the corresponding
results will be deleted.
4.5 Manual Calibration

After the calibration of calibrating material and fresh blood, whose results being saved, the obtained
calibration factor will be saved in “Manual Calibration” screen.
Click “Calibration” in main menu list and select “Manual”, as shown in the figure below:
33
Fig. 4-5-1
When calibration factor requires minor adjustment, click the adjusted data line under “Calibration Factor(%)”,
input data via soft keyboard, and click “Enter” to confirm. After the modification, click “Save”, it will prompt
“Saving complete”. Click “OK”, the dialog box will close.
4.6 Calibration Log

The device will record every calibration information for users to check.
Click “Calibration” in main menu list and select “Calibration Log” button, as shown in the figure below:
Fig. 4-6-1
Calibration Log displays the latest 100 calibration times, methods and factors in list order. If calibration count
exceeds 100 times, calibration record saved at first will be covered automatically. If the record is more than
one page users can view records by clicking “↑” and “↓”.
34
Condition query: operators can view calibration records selectively based on calibration method and click “ ”
behind “Condition Query”, the drop-down list will be shown:
Fig. 4-6-2
If selected query condition is empty, all calibration records will be displayed.
35
Chapter 5 QC(Quality Control)

The Analyzer may have deviation to a certain extent in its long-term use. Wrong or unreliable analysis results
may be caused by the deviation. QC program provides an effective method to detect possibly existing
deviation. QC test can verify the accuracy of daily analyzed sample results.
To ensure the reliability of sample analysis results, it is recommended to conduct daily QC test for QC
materials with low, medium and high levels respectively on the Analyzer.
Analyzer can be put into QC test only after correct calibration.
The Analyzer provides 2 QC methods: L-J/Xbar QC and X-B(moving average method)QC.
5.2 L-J/X-Bar QC
With L-J/Xbar QC, operator can conduct QC on 20 parameters(exclusive of P_LCC). The Analyzer provides
12 QC documents in total in order to save QC parameters and results. Every QC file can automatically save a
maximum of 30 groups of QC results. When the QC running times is larger than 30, new QC results will
override the QC results from the very first.
Xbar QC has twice tests, using mean as the QC data. Other operations are the same to those of L-J QC.
Click “QC” button in the main menu and select “L-J/Xbar QC”; thus, the display is as shown as the following:
Fig. 5-2-1
5.2.1 QC Basic Set

5.2.1.1 Lot No. information set
Click “QC basic” button in “L-J/Xbar QC” interface and the display is shown as the following:
36
Fig. 5-2-2
(1)Setting of file No.:
Click “ ” after “File No.” and select QC file No. in the drop-down list, with options from 1-12.
(2)Setting of QC lot No.:
Click the input box “Lot No.” and enter lot No. through soft keyboard.
(3)Setting of validity:
Click the input box “validity” and enter lot No. through soft keyboard.
(4)Setting of QC level:
Click “ ” after “Level” and select a QC level(high, middle and low)in the drop-down list for every QC lot.
After the completion of input, click “Save” button; then a pop-up shows that “Save file information or not”;
press “OK” button to save the set parameters.
(5)Input of target value and deviation limit:
Click the input boxes of target value and deviation limit of each item, input corresponding target value and
deviation limit through soft keyboard and press “Enter” key to save the input values.
See Instructions for Use of QC Materials for lot No., validity, target value and deviation limit of QC
materials.
5.2.1.2 Take default
Operator can select saved QC results in QC chart to calculate Mean(average value), SD(standard deviation)and
CV(coefficient of variation), taking them as default in QC editing.
(1)Setting of deviation limit:
See “3.5.1 L-J/X bar” section for adjustment of the display format of deviation limit or the calculation method
of deviation limit in default.
Calculation method and range selection of deviation:
When “absolute value” is selected as calculation method, the list will display the input deviation limit in
absolute value manner, and the “range” will be 2 times of standard deviation(2SD)or 3 times of standard
deviation(3SD), being the deviation limit.
37
When “percentage” is selected as calculation method, the list will display the input deviation limit in
percentage manner, and the “range” will be 2 times of standard deviation(2CV)or 3 times of standard
deviation(3CV), being the deviation limit.
(2)Take default
Click “Take default” button and thus the target value and deviation limit obtained through the set method will
be the target value and deviation limit in the current QC file and display in the list.
If the number of saved QC results is less than 3, a pop-up will prompt that “The number of records is
less than 3; taking default is forbidden!” Click “OK” button to close the current dialog.
(3)Removal and recovery of abnormal QC points:
If there are any abnormal QC points in the QC chart, it is allowed to remove them and then take default:
After clicking the “Take default” in the lower right corner, in case that the number of saved QC data is less
than 3, the display will automatically shift to the QC chart interface:
Fig. 5-2-3
a)For instance, the first point from the right side. Click it and the red cursor line will stay on the point. Then
click the “Remove” button in the lower right corner and the selected QC point will become “Black point”,
which indicates the removal of the abnormal point. Taking default for calculation does not include the point.
b)Click “Calculate” button and thus the display returns to “QC basic” interface and the calculation results
are shown in the list.
c)In case of recovering a removed QC point, it is allowed to click the point and the red cursor line will
automatically stay on the point. Then click “Add” button; thus, the black QC point will become red or green
and the removed point will recover to normal conditions.
Taking default is using effective QC results to calculate target value and deviation limit.
5.2.2 QC Count
Click “QC count” button in “L-J/Xbar QC” and the display is as shown as the following:
38
Fig. 5-2-4
● User must use the QC materials specified by Dirui, or else the QC results may be unreliable.
● See Instructions for Use of QC Materials for the use and storage of QC materials.
(1)QC count
Finish the QC count according to the following steps:
a)Put the tube with mixing QC materials under the sampling probe, to realize the suction of the sample.
b)Press Count button and the sampling probe will automatically aspirate QC materials. After lifting the
sampling probe, operator can remove the tube and release the aspirated QC materials to the count pool. The
Analyzer will perform calibration counting process and the screen bottom will display“Counting…”,“Data
Processing…”.
c)After the completion of analysis, the sampling resets for the preparation of next calibration count and
results obtained after the count will be shown in the screen.
(2)Check of QC values
After the completion of QC test, operator can check the QC results saved in the current QC file through “←”
and “→” in the lower part of the screen.
5.2.3 QC Chart
Click “QC chart” button in “L-J/Xbar QC” and the display is showed as following figure:
39
Fig. 5-2-5
(1)Interface description:
The horizontal axis in the QC chart means the number of QC results in th QC file. And the vertical axis means
the QC results of each parameter.
Those marked by vertical bar belong to the same QC data and for each parameter, its QC chart can display a
maximum of 30 points.
For each parameter, the three values in the left side of the QC chart from top to bottom represent the three
boundary values: upper limit, target value and lower limit respectively.
Upper limit: target value of QC material + deviation
Target value: target value of QC material
Lower limit: QC material target value + deviation
For each parameter, the three values in the right side of the QC chart are SD(standard deviation),
Mean(average value)and CV(coefficient of variation)respectively.
(2)Descriptions of various points in the QC chart:
Each point in the QC chart corresponds to a quality control result and each point is connected with line
segments.
“Green point” means that the QC result is within the QC range and the “Red point” means that the QC result is
not within the QC range.
(3)If the QC results of the current day in the QC chart is not within the QC range, it is recommended to take
the following steps:
a)Check whether the input of target value and deviation limit of QC materials is correct.
b)Check whether the background test in normal.
If two or more points are normal, repeat one QC counting. And if there is any QC point is abnormal in the QC
chart, take QC counting again after calibrating the Analyzer again.
If abnormal point still exists, contact After-sales Service Department of Dirui.
5.2.4 QC List
User can select different QC files for QC data check.
Click “QC list” in the “L-J/Xbar QC” interface and select file No. in the drop-down list of “File No.”. The
display is as shown as the following:
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Fig. 5-2-6
(1)Delete: select QC data to be deleted in the current QC file and click “Delete” button; thus, a prompt box
pops up:
Fig. 5-2-7
Click “OK” button to delete the selected QC results; yet click “Cancel” button not to delete the records.
(2)Delete all: click “Delete all” button; thus, a prompt box pops up:
Fig. 5-2-8
Click “OK” button to delete all QC results in the current QC file; yet click “Cancel” button not to delete the
records.
5.3 X-B QC
X-B(moving average method), put forward by Dr. Brian Bull, realizes the monitoring of performance of the
41
Analyzer through monitoring stability of MCV, MCH and MCHC, three parameters of red blood cell. It is a
QC method without QC materials, different from that with QC materials. They are performance monitoring
means of Analyzer, reflecting the performances of Analyzer from different respects and not replacing each
other.
If the daily sample quantity of Analyzer is larger than 100, it is recommended to use X-B QC. The QC method
is required to use random samples so that it is not applicable to samples classified based on disease categories.
It has a reference range consisting of given reference value and upper and lower limits, aiming for variation
trend of QC results in reference range.
In the X-B QC of the Analyzer on the three parameters MCV, MCH and MCHC, the sample quantity of each
group for X-B value analysis is 20-200 and samples derive from results of the normal count of the Analyzer,
without difference in whole blood and prediluted modes.
It is necessary to calibrate the Analyzer before test as X-B QC reference value is the statistic analysis result of
a lot of random samples.
5.3.1 QC Parameter Set
Click the “QC” button in the main menu and select and click “XB QC” to enter “XB basic” interface:
Fig. 5-3-1
Target value: click the input box and enter target value through soft keyboard. Due to somewhat difference of
data references in different areas, sample quantity is required to reach a certain amount(larger than 500 is
recommended), using their arithmetic mean as the target value of X-B QC.
Deviation limit: click the input box and enter deviation value through soft keyboard. It is better to use 3%~5%
of target value as corresponding deviation limit.
Target value and deviation limit can not be null.

5.3.2 QC Count
After the parameter settings of X-B QC, in case that the sample quantity for Analyzer reaches the set
value(refer to setting of “Sample Num/Group” in “3.5.2 X-B QC”), the system will automatically conduct a
X-B calculation; thus, a QC point is given for each X-B QC parameter correspondingly and is saved in X-B
chart and X-B list.
Blank result, clog data and data that are beyond the display range of the instrument(the data display is
42
****)are not counted into the statistic range of X-B QC.

5.3.3 QC Chart
Click “XB chart” button and the display is showed as following figure:
Fig. 5-3-2
(1)QC chart description:
The horizontal axis in the QC chart means the number of QC results in th QC file. And the vertical axis means
the QC results of each parameter.
For each parameter, the three values in the left side of the QC chart from top to bottom represent the three
boundary values: upper limit, target value and lower limit respectively.
Upper limit: target value of QC material + deviation
Target value: target value of QC material
Lower limit: QC material target value + deviation
For each parameter, the three values in the right side of the QC chart represent SD(standard deviation),
Mean(average value)and CV(coefficient of variation)respectively.
(2)Descriptions of various points in the QC chart:
Each point in the QC chart corresponds to a quality control result and each point is connected with line
segments.
“Green point” means that the QC result is within the QC range and the “Red point” means that the QC result is
not within the QC range.
(3)If intraday QC results in the QC chart are not within the QC range, it is recommended to take the following
steps:
a)Check whether the input of target value and deviation limit is correct.
b)Check whether the background test in normal.
If two or more points are normal, repeat one QC counting. And if there is any QC point is abnormal in the QC
chart, take QC counting again after calibrating the Analyzer again.
If abnormal point still exists, contact After-sales Service Department of Dirui.
(4)Check of QC data:
Operator can click “←” and “←” buttons to check QC results. QC results for each QC point is displayed
below the parameter names and the position of QC point and the total QC result is displayed in the lower left
43
corner of the interface in the manner of “Position/total”.

5.3.4 QC List
Click “XB QC list” button and the display is shown as the following figure:
Fig. 5-3-3
(1)Delete: select QC result to be deleted and click “Delete” button; thus, a pop-up prompts that “Are you sure
to delete current record?” Click “OK” button to delete the selected QC result.
(2)Delete all: click “Delete all” button; thus, a pop-up prompts that “Are you sure to delete all of records?”
Click “OK” button to delete all QC results in the current QC file.
Target value and deviation limit can not be deleted.
44
Chapter 6 Conventional Operation

The chapter introduces the whole daily operation process of the Analyzer from starting up to power off, paying
much attention to the detailed instructions of operation processes for analysis of the whole blood and
prediluted(peripheral blood)samples.
Daily operation processes are as follows:
Fig. 6-1-1
6.2 Preparations before Operation

Before turning on the switch of the Analyzer, operator should conduct checks according to the following
requirements to ensure the readiness of the system.
(1)Check liquid waste barrel
Ensure the empty status of liquid waste barrel before daily start-up.
(2)Check liquid pipeline
Check whether there is buckling in pipelines connecting reagent bottle/barrel or(liquid waste barrel), whether
the connection is reliable and whether reagent volume is sufficient.
(3)Check power supply
Check whether the power line of the Analyzer is well connected.
(4)Check printer(optional)
Check whether the data line of printer is well connected with the Analyzer and whether power line is correctly
connected.
Check whether the paper is sufficient and whether the installation is in place.
(5)Check bar-code scanner
Check whether the power line of external bar-code scanner is well connected to the Analyzer.
6.3 Start-up
After turning on the power switch, the screen displays “System Loading…” and the Analyzer proceeds with
initialization. See “2.3.7 Initial start-up” for details.
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6.4 Daily QC
Before sample analysis, it is necessary to conduct daily QC analysis for the Analyzer to ensure reliable
analysis results. See “Chapter 5 QC(Quality Control)” for detailed operations.
6.5 Preparation of Samples

6.5.1 Whole Blood Sample
The preparation method of whole blood sample is as follows:
(1)Collect venous blood samples with clean EDTA-K2(1.5~2.2 mg/mL blood)anticoagulation vacuum tube,
ensuring a collected sample volume larger than 500 μL.
(2)Quickly mix the venous blood in the tube with the anticoagulation.
● Operator should use clean EDTA-K2 anticoagulation vacuum tube, silicide glass/plastic tube and 20
μL silicon boride glass capillary tube.
● Samples for white blood cell separation or platelet count should be kept at room temperature and be
used for analysis within 8 hours after collection.
● In case that PLT and MCV analysis results are not needed, it is allowed to preserve them in
refrigerator at 2°C~8°C for 24 hours. Analysis for refrigerated samples can be conducted only after they
are placed in room temperature at least 30 min.
● Stand the sample for a while, and re-mix it before analysis.
6.5.2 Prediluted Sample(Peripheral Blood)
The preparation method of prediluted sample is as follows:
(1)Click the “Add diluent” button in the main menu, as shown in the following figure:
Fig. 6-5-1
(2)Click the “Prepare” button. A prompt “Diluent is under the preparation...” is shown in the lower part of the
interface:
(3)Take a clean centrifuge tube and put it under the sampling probe in an angle the same to the figure and press
the Count button(a prompt “Adding diluent...” is shown in the lower part of the interface). Make sure the
diluent flows into the centrifuge tube along the tube wall to avoid bubbling or side flow:
46
Fig. 6-5-2
(4)Collect 20 μL peripheral blood, inject them quickly along the tube wall of centrifuge tube with diluent and
mix them evenly.
In case of continuous preparation of several prediluted samples, repeat the(3)and(4)steps. The continuous
preparation can at most finish 10 prediluted samples. After the completion of 10 sample pre-dilution, the
instrument will automatically prepare for diluent. After the preparation, it is allowed to continuously prepare
prediluted samples.
(5)Click the “Stop” button in the interface. A prompt “Stopping...” is shown in the lower part of the interface.
Then return to the above interface after completion.
● Operator can also use pipette to draw in 700 μL diluent and add it into the centrifuge tube, then
quickly inject the collected 20 μL peripheral blood along the tube wall and mix them evenly.
● Keep the prepared diluent away from any dust, or else analysis errors may occur.
● The fully mixed peripheral blood and diluent should be placed for 3 min and then re-mixed for
analysis.
● Ensure that the analysis is conducted within 30 min after the sample dilution, or else the obtained
analysis results may be unreliable.
● Stand the sample for a while, and re-mix it before analysis.
● Every lab should have evaluation towards the stability of sample analysis results in prediluted mode
according to corresponding sample quantity, sampling method and technical level.
6.6 Sample Entry
Operator can edit the samples to be analyzed before their analysis.

6.6.1 Add Sample
Click “Worksheet” button in the main menu, as shown in the following figure:
47
Fig. 6-6-1
Click “Add” button. Thus, a new record will be added at the bottom of the list and the information entry fields
of the record is in revisable status.
(1)Sample No.: click the input box and input the sample number through soft keyboard.
Sample No. can only be digitals or “-” and must be started and ended with digitals, with a maximum of 8
digitals.
(2)Mode: newly-added records are defaulted in the currently used mode of the instrument and “Whole blood”
or “Pre-diluted” can be selected from the drop-down list.
(3)Reference: newly-added records are defaulted in the currently used reference range of the instrument and
“Common, Male adult, Female adult, Child, Newborn, Default 1-5” can be selected from the drop-down list.
(4)Barcode: it can be input manually or through scanning. Manual input can have 16 digitals and if the scanned
barcode exceeds 16 digitals, only the first 16 digitals are shown.
(5)Status: newly-added records are defaulted in “to be tested” status which cannot be changed. After the
completion of test, the status automatically changes to “Completed”.
Press “←” and “→” buttons to turn page left and right, as shown in the figure:
48
Fig. 6-6-2
(6)Name: enter patient's name directly.
(7)Gender: select “Blank, Male or Female” from the drop-down list.
(8)Age: enter patient's age directly, with a maximum of 199 and only digitals.
(9)Unit of age: newly-added records are defaulted as “Year” and can be “Year, Month, Day or Hour” selected
from the drop-down list.
(10)Case No.: enter patient's case No. directly, with a maximum of 20 digitals.
Press “←” and “→” buttons to turn page left and right:
Fig. 6-6-3
(11)Sample time and deliver time: for newly-added records, they are defaulted as the current time and can be
changed directly.
49
(12)Department: select the set department directly in the drop-down list.

(13)Bed No.: enter patient's bed No. directly, with a maximum of 20 digitals.
(14)Expense: select the set expense directly in the drop-down list.
If added samples list more than one page, press “↑” and “↓” buttons to turn pages.
A maximum of 100 patient records can be added on the worksheet. If there are 100 records, after
clicking “Add” button, a prompt “Maximum records are reached” is given; user can add information
only after deleting the tested records.
6.6.2 Sample Delete
Click “Delete” button to select record categories to be deleted in the drop-down list:
(1)Current records: currently selected records are deleted;
(2)All records: all records are deleted;
(3)Tested records: records in “Completed” status are deleted;
(4)Records to be tested: records in “To be tested” status are deleted.
6.7 Analysis of Whole Blood Sample
● When the “Prediluted” mode is changed to “Whole blood” mode, the Analyzer will automatically
clean pipelines.
● Before sample analysis, set the reference range of parameters on the “Set” screen; otherwise, the
screen may prompt false alarm after sample testing.
● After selecting the working mode, conduct the test directly. The default reference range is “Common”.
Upon finishing of analysis, the relevant alarm will be prompted based on the reference range set by the
“Common” type.
6.7.1 Mode Switch
Click “Mode switch” in the main menu, as shown in the figure:
Fig. 6-7-1
50
(1)Select “ ”
a)Sample number and reference will be subject to those listed in the worksheet;
b)Select “Whole blood” in “Mode” and click “OK” button.
(2)Do not select “ ”

a)Sample number will be subject to the actual test. Input the number of next testing sample in the “Sample
No.”;
b)Select the reference range of the analytic sample in the drop-down list, which defaults as “Common”;
c)Select “Whole blood” in “Mode” and click “OK” button.
digitals.
6.7.2 Whole Blood Count
Complete the analysis of whole blood samples according to the following steps:
(1)Ensure the count status in the status indicator field is “Ready” and the work mode is “Whole blood”.
(2)Put test tube containing blending whole blood under sampling probe to make sampling probe aspirate the
sample.
(3)Press the “Count” button, and the sampling probe will automatically aspirate in the sample. After lifting the
sampling probe, operator can remove the tube and sampling probe will put sample into the count pool. The
Analyzer will take counting and the screen bottom will display “Counting…” and “Data Analyzing…”.
(5)If the auto print is set as “On”, the Analyzer will print the report subject to the setting automatically; if the
auto communication is set as “Yes”, the Analyzer will automatically give the analytic result to the outer
computer.
(6)Repeat the above steps for other samples.
(7)If patient information of the tested sample needs modification, click “Count” button in the main menu and
click “Patient Information”. See “Article 6.6.1 Add Sample” for input method of parameter in worksheet.
(8)Click “Count” button in the main menu and click “Fig. type browsing” or “List browsing”. Click “Print”
button and select “Current record, Selected record or all records” for report print.
● When “Counted according to the worksheet” is selected, conduct tests in the sequence in the
worksheet; when “Counted according to the worksheet” , conduct tests according to the sequence of
sample Nos., which has no influence on input information in the worksheet, that is to say, the “Status”
column in the “Worksheet” interface displays “To be tested” for the input information after the
completion of tests.
● When “Whole blood” mode and “Counted according to the worksheet” in the “Mode switch” are
selected , if there are samples in whole blood mode in the worksheet, tests will skip such samples.
● When it is counted according to the worksheet, and input sample information in the work sheet is less
than the sample quantity for tests, the Analyzer will continue to test based on postponed sample Nos. For
samples without entry, it is allowed to edit patient information in “Patient info.” interface based on
sample Nos. after tests.
6.8 Analysis of Prediluted Sample
● Before sample analysis, set the reference range of parameters on the “Set” screen; otherwise, the
screen may prompt false alarm after sample testing.
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● After selecting the working mode, conduct the test directly . The default reference range is “Common”.
Upon finishing of analysis, the relevant alarm will be prompted based on the reference range set by the
“Common” type.
6.8.1 Mode Switch
Click “Mode switch” button in the main menu, as shown in the following figure:
Fig. 6-8-1
(1)Select “ ”
a)Sample number and reference will be subject to those listed in the worksheet;
b)Select “prediluted” in “Mode” and click “OK” button.
(2)Do not select “ ”

a)Sample number will be subject to the actual test. Input the number of next testing sample in the “Sample
No.”;
b)Select the reference range of the analytic sample in the drop-down list, which defaults as “Common”;
c)Select “prediluted” in “Mode” and click “OK” button.
digitals.
6.8.2 Prediluted Count
(1)Ensure the count status in the status indicator field is “Ready” and the work mode is “Prediluted”.
(2)Prepare peripheral blood proportionally and put it under sampling probe to make sampling probe draw in
the sample.
(3)Press the “Count” button, and the sampling probe will automatically aspirate the sample. After lifting the
sampling probe, operator can remove the tube and sampling probe will put sample into the count pool. The
Analyzer will take counting and the screen bottom will display “Counting…” and “Data Analyzing…”.
(5)If the auto print is set as “On”, the Analyzer will print the report subject to the setting automatically; if the
auto communication is set as “Yes”, the Analyzer will automatically give the analytic result to the outer
52
computer.
(6)Repeat the above steps for other samples.
(7)If patient information of the tested sample needs modification , click “Count” button in the main menu and
click “Patient Information”. See “Article 6.6.1 Add Sample” for input method of parameter in worksheet.
(8)Click “Count” button in the main menu and click “Fig. type browsing” or “List browsing”. Click “Print”
button and select “Current record, Selected record or all records” for report print.
● When “Counted according to the worksheet” is not selected , conduct tests in the sequence in the
worksheet; when “Counted according to the worksheet” is not selected, tests have no influence on input
information in the worksheet, that is to say, the “Status” column in the “Worksheet” interface displays
“To be tested” for the input information after the completion of tests.
● When “Prediluted” mode and “Counted according to the worksheet” in the “Mode Switch” are not
selected, if there are samples in prediluted mode in the worksheet, tests will skip such samples. User 2013-09-03 14:52
● When it is counted according to the worksheet, and input sample information in the work sheet is less 删除的内容:
than the sample quantity for tests, the Analyzer will continue to test based on postponed sample Nos. For
samples without entry, it is allowed to edit patient information in “Patient infor.” interface based on
sample Nos. after tests.
6.9 Parameter Alarm

6.9.1 Categories of Parameter Alarms
Parameter alarms will occur in the following three situations: User 2013-09-03 10:24
Count results are marked with “↑” or “↓”, which indicates that the obtained count results are beyond preset 删除的内容:
reference range.
Count results are shown as “***”, which indicates that test results are in invalid or beyond the displayed range.
Count results reflect clogging and the clogging results are followed by “?”. After the instrument autoruns clog
removal, the system will give a prompt “Sample No. * abnormal result. Retest or not?” Click “No” to save the
clogging data and to continue to test the next sample; Click “Yes” to retest the sample and after the test, the
instrument will automatically override the clog data.
6.9.2 Category or Form Abnormal Alarm
The Analyzer can alarm WBC, RBC/HGB and PLT anomalies according to histogram, with prompts as shown
in the following table:
RBC/PLT alarm
Unequal corpuscular volume RDW-SD> 65.0 fL or RDW-CV> 20.0 %
Parvicellular red blood cell MCV< 70.00 fL
Macrocytic red blood cell MCV> 110.0 fL
Hypochromia MCHC< 290.00 g/L
Anemia HGB< 100.00 g/L
Erythrocytosis RBC> 6.50 1012/L
Thrombocytopenia PLT< 60 109/L
Thrombocytosis PLT> 600 109/L
WBC alarm
WBC Decrease WBC < 2.50 109/L
WBC Increase WBC > 18.00 109/L
Minicell decrease LYM#< 0.60 109/L or LYM% < 0.0 %
Minicell increase LYM#> 4.00 109/L or LYM% > 100.0 %
NEU Decrease NEU#< 1.00 109/L or NEU% < 0.0 %
NEU Increase NEU#> 11.00 109/L or NEU% > 100.0 %
53
6.10 Sleep
In case of no operation in the set duration, the Analyzer will enter sleep status which is displayed in fault
information area. Press “Count” button to wake up the system. If the screen is not used and the duration
reaches the set screen sleep duration, the screen will enter sleep status and can be waken up by clicking any
position of the screen.
6.11 Rinse
The Analyzer automatically rinse all parts where samples flow through in every count process and ensure no
sample residues in the liquid pipelines. Washed parts are as follows:
(1)Internal and external parts of sampling probe;
(2)Count pool.
6.12 Shut-down
In order to ensure the stability of the Analyzer and the accuracy of analysis results, if the Analyzer
continuously works for 24 hours, operator should shut down the Analyzer according to requirements.
Click “Shutdown” button in the main menu and a prompt box pops up:
Fig. 6-12-1
Click “OK” to ensure the instrument to automatically aspirate cleaning solution, prompting “Shutting down...”;
it takes about 20 min to shut down and after it, the system will prompt that “It is shut down. Please turn off the
power or click the restart button to restart the system.”
After prompt for shutdown(before turning off power), if tests should be continued, click “Restart”
button.
At the moment, it is allowed to set the power switch at the right-rear side of the host in “0” and to turn off the
power of the instrument.
After shutdown, please drain off the liquid waste in the liquid waste barrel and properly dispose the liquid
waste.
54
Chapter 7 Result Query

After every sample analysis, the Analyzer will automatically save the analysis results in database. The
database can store at most 10,000 sample analysis results with each including 21 parameter results and 3
histograms. Operator can inquire all sample results saved in the database. When the quantity of stored samples
is larger than 10,000, previous sample results will be automatically overridden.
7.1.1 Graphic
Click the “Count” button in main menu and then click “Graphic” button. The interface is displayed as the
following figure:
Fig. 7-1-1
Sample results are shown in the manner of value and graphic. Numbers in the right side are available for check
of their corresponding samples which are their positions in the sample database. Their positions in the sample
database and the total sample results in the sample database are shown in the form of “position/total” in the
lower right corner of the interface.
7.1.2 List
Click the “Count” button in main menu and then click “List” button. The interface is displayed as the
following figure:
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Fig. 7-1-2
Results are listed in the sample database in sequence(based on the program default, the last tested result is
listed in the most front of the list).
“↑” or “↓” button in the right side of the screen is available for check page by page. Their positions in the
sample database and the total sample results in the sample database are shown in the form of “position/total” in
the lower right corner of the interface.
The following introductions on functions of CV value calculation, deletion, query, selection, jump, LIS and
print are applicable to graphic and list browsing.
7.2 CV
Users are allowed to select 3 or more records for the calculation of mean, standard deviation(SD)and
coefficient of variation(CV). If the number of selected records is less than 3, the software has no reaction and
fails to calculate after clicking “CV” button.
Click “□” in front of record number in the right side of the interface, marking “□” with “×” which indicates
“selected”, as shown in the following figure:
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Fig. 7-2-1
After number selection, click “CV” button and the interface is as the following figure:
Fig. 7-2-2
If a certain parameter of the selected sample is invalid(shown as *.**), then the repeatability index of the
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parameter is invalid.
Click “Exit” button to quit the CV calculation interface.
7.3 Deletion
Click “Delete” button in “Graphic” or “List” interface:
(1)Select “Current record” in the drop-down list and a prompt pops up – “Delete the current record?”. Click
“OK” button and the current selected record is deleted;
(2)Select “Selected record” in the drop-down list and a prompt pops up – “Delete the selected record?”. Click
“OK” button and the selected records are deleted(those marked “×” in “□” are selected);
(3)Select “All records” in the drop-down list and a prompt pops up – “Delete all records?”. Click “OK” button
and all records are deleted.
7.4 Query
User can select different conditions for data query in sample database.
7.4.1 All Query
Click “** query” in the menu bar at the bottom and select “All query” in the drop-down list; thus, all sample
results in the sample database will be displayed (“↑” or “↓” button is available for check page by page).
7.4.2 Condition Query
Click “** query” in the menu bar at the bottom and select “Condition query” from the drop-down list. The
display is shown as below:
Fig. 7-4-1
Either one of the conditions or a combination of several conditions may be used for query; query can be based
on fuzzy query or complete matching(i.e. “ ”).
7.4.2.1 Query based on sample No.
Enter sample number in the input box after “Sample No.”. For example, if the input sample number is “1”,
after clicking “OK” button, all sample results in numbers including “1” are displayed:
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Fig. 7-4-2
If the input sample number is “1” and meanwhile “ ” is selected, after clicking “OK”
button, only the sample result numbered “1” is displayed:
Fig. 7-4-3
7.4.2.2 Query based on mode
Click the drop-own list in mode and select the mode to be inquired among “Blank, Whole blood and
Prediluted”. After clicking “OK” button, sample results that match the selection conditions will be displayed.
7.4.2.3 Query based on reference category
Click the drop-down list in reference and select the reference category to be inquired among “Blank, Common,
Male adult, Female adult, Child, Newborn, Default 1-5”. After clicking “OK” button, sample results that match
the selection conditions will be displayed.
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7.4.2.4 Query based on name

Enter the name of the patient to be inquired in the input box of name. For example, “Wang Hong” is input.
After clicking “OK” button, all sample results with names including “Wang Hong” will be displayed; if
“ ” is selected, after clicking “OK” button, only sample results of patient named “Wang
Hong” will be shown.
7.4.2.5 Query based on gender
Click the drop-own list in gender and select the gender to be inquired among “Blank, Male and Female”. After
clicking “OK” button, sample results that match the selection conditions will be displayed in the interface.
7.4.2.6 Query based on age
Enter number in the input box after age. If the unit of age is blank, for example entering “10”, after clicking
“OK” button, all sample results with age including “10” will be displayed; if the unit of age is selected from
“Year”, “Month”, “Day” and “Hour”, for example selecting “Year”, after clicking “OK” button, all sample
results with age including “10” will be displayed(with the unit of age being “Year”); if selecting
“ ” and then clicking “OK” button, only sample results of “10 years old” patients are
displayed.
7.4.2.7 Query based on expense and dept.
Click the drop-down list in expense and select “Blank or Set information”. After clicking “OK” button, sample
results that match the selection conditions are shown.
Operations of query based on dept. are same to those of the query based on expense.
7.4.2.8 Query based on barcode, case No. and bed No.
Enter barcode in input box of barcode. For example, the barcode input is “12”. After clicking “OK” button, all
sample results with barcode including “12” are shown; if selecting “ ” and then clicking
“OK” button, only sample results of with barcode of “12” are displayed.
Operations of query based on case No. and bed No. are same to those of the query based on barcode.
7.4.2.9 Query based on sample time, deliver time and test time
Select “ ” and input the starting and ending time to be inquired. After clicking “OK” button,
sample results that match the selection conditions are shown.
Operations of query based on deliver time and test time are same to that of the query based on sample time.
7.5 Selection
Operator is allowed to inquire several sample results with positions known in sample database. After clicking
“Select” button and selecting “Condition selection” in its drop-down list, the interface is shown as the
following figure:
Fig. 7-5-1
Enter the starting and ending sequence numbers of sample position and click “OK” button; thus, selected
sample results are shown in the interface:
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Fig. 7-5-2
The input start sequence number must be less or equal to the end sequence number; the input sequence
numbers of sample positions should be within the range of sample database; if the input number is
larger than the upper limit of the input range, the software will automatically change the input number
to the upper limit of the input range. For example, the selected interface shows that: input range [1-100],
but the actual input is 90-110, thus automatically changing 110 to 100.
If “Deselect” is selected from the drop-down list, the selected sample records are canceled.
7.6 Jump
Operator is allowed for query of sample results with positions known in sample database. After clicking “Jump
to” button, the interface is shown as the following figure:
Fig. 7-6-1
Enter position sequence number in input box and click “OK” button; thus, the selected sample result is shown
in the interface and meanwhile the record number in the right side of the interface becomes highlighted.
The input sequence numbers of sample positions should be within the range of sample database; if the
input number is larger than the upper limit of the input range shown in the interface, the software will
automatically change the input number to the upper limit of the input range.
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7.7 LIS
Data transmission with LIS can be conducted by clicking “LIS” button:
(1)Select “Current record” from the drop-down list and a prompt pops up “Send the current record?”. After
clicking “OK” button, “Transmission succeeds”(or “Transmission error” prompt is given).
(2)Select “Selected records” in the drop-down list and a prompt pops up a prompt “Send the selected records?”.
After clicking “OK” button, “Transmission succeeds”(or “Transmission error” prompt is given).
(3)Select “All records” in the drop-down list and the interface pops up a prompt “Send all records?”. After
clicking “OK” button, “Transmission succeeds”(or “Transmission error” prompt is given).
7.8 Print
After correct connection with the printer, it is allowed to click “Print” button; thus, the display is shown as the
following figure:
Fig. 7-8-1
Select “Current record”, “Selected records” or “All records” in the drop-down list behind “Print” and then
records meeting requirements will be printed.
If the “Print type” is set to be “Inner print” and “Paper skip” is selected from the drop-down list, the built-in
printer will automatically conduct the paper skip.
7.9 Data Backup

Operator can save test data after data export. Click “Count” button in the main menu and then click “Data
backup” button, and the interface is shown as figure below:
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Fig. 7-9-1
After inserting USB flash disk in the USB interface on rear side of the instrument, click the “Data backup” in
the interface to export data and save them in USB flash disk;
If it is necessary to recover the exported data, click “Data recovery” button in the interface to import data in
the USB flash disk to instrument.
It is necessary to effectively backup data so as to prevent loss of data in case of fault in hardware or
software.
7.10 Histogram Adjustment

Operator can adjust the histogram based on current latest test sample results. Click “Count” button in the main
menu and then click “Histogram adjust” button in the left side; thus, Fig. 7-10-1 pops up: in the menu, it is
allowed to move the identification line of grain size, recounting data.
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Fig. 7-10-1
Click the WBC histogram in the above figure. Three options 1, 2 and 3 below are the three identification lines
in the WBC histogram respectively. Click 1, 2, and 3 options and select the identification line to be adjusted;
thus, the selected identification line becomes green. Adjust the position of identification line via “ ” button
and “ ” button. Along with the change of identification line, the measured data will be recalculated based
on the new position of the identification line. After adjustment, click “Save” to save the adjusted data.
Otherwise, the data will not be saved.
Click RBC histogram in above figure and the interface is shown as the following figure:
Fig. 7-10-2
Two options 1 and 2 at the lower part of the interface are the two identification lines in the RBC histogram
respectively. Click 1 and 2 options and select the identification line to be adjusted; thus, the selected
identification line becomes green. Adjust the position of identification line via “ ” button and “ ” button.
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Along with the change of identification line, the measured data will be recalculated based on the new position
of the identification line. After adjustment, click “Save” to save the adjusted data. Otherwise, the data will not
be saved.
The adjustment method of PLT histogram is the same to that of RBC histogram.
7.11 Data Adjustment

Click “Count” button in the main menu and then click “Data adjust” button in the left side. The interface
displays as the figure below:
Fig. 7-11-1
Click the data result column, enter adjusted result through soft keyboard and click “ENTER” key to confirm it.
65
Chapter 8 Maintenance

In order to guarantee the correct and effective operations of the Analyzer and to prolong the service life of the
Analyzer, users are required to conduct daily maintenance to the Analyzer according to requirements. In spite
that the Analyzer will automatically prompt users to conduct corresponding maintenance after testing a certain
amount of samples or continuously operating a period of time, users should also prepare a suitable
maintenance plan according to specific lab conditions, such as daily sample volume, operation conditions and
operation duration of the Analyzer, to reduce various factors that influence accuracy of analysis, so as to
ensure the safe, stable and effective operations of the system.
Inappropriate maintenance may damage the Analyzer. Operator must conduct maintenance according
to User Manual. In case of any indefinite problems in User Manual, please contact the After-sale Service
Department of Dirui and seek maintenance advices from appointed professionals.
8.2 Maintenance Guideline

8.2.1 Regular Maintenance
(1)Daily maintenance:
Perform QC before daily blood sample analysis. See “Chapter 5 QC(Quality Control)” for operation methods
of QC.
If the system is not shut down all day round, it is necessary to conduct “Rinse device” operation per day; click
“Rinse device” button in the main menu and the instrument performs rinsing.
If the system is not shut down all day round, it is necessary to conduct rinsing in “WBC pool” and “RBC pool”
per day: click “Service” button in the main menu, then click “Rinse” button to enter Rinse interface and then
click “WBC pool” and “RBC pool” for rinsing; other operations are not allowed in the rinsing process and the
rinsing cannot be stopped until finished.
(2)Weekly maintenance:
If the system is shut down normally, it is necessary to conduct soaking in “WBC pool” and “RBC pool”
weekly: click “Service” button in the main menu, then click “Maintenance” button to enter Maintenance
interface and then click “WBC pool” and “RBC pool” in the area of Soaking for soaking; other operations are
not allowed in the soaking process and the soaking cannot be stopped until finished.
(3)Monthly maintenance:
If the system is shut down normally, it is necessary to conduct “Swab” rinsing monthly:
a)Wipe the crystallization at the top pf swab with cotton swab dipped with distilled water, as shown in the
figure:
Fig. 8-2-1
b)Click “Service” button in the main menu, then click “Rinse” button to enter Rinse interface and then click
“Swab” for rinsing; other operations are not allowed in the rinsing process and the rinsing cannot be
stopped until finished.
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8.2.2 Timely Maintenance

User can set the automatic rinse interval(with setting range: 10~200 times)in “Setting”, with which the
instrument will automatically conduct rinsing device operation when tests reach the set times.
If the Analyzer does not work for more than 2 weeks, replace the reagents(lyse and diluent)with distilled water,
perform the “Package rinse pipe” operation in “Service” → “Maintenance” menu; then disconnect distilled
water, and conduct “Package empty pipe” operation; After the completion of the above two operations, put the
Analyzer in clean area.
In case of clog fault in the Analyzer, a prompt “data abnormal, to retest or not” pops up and meanwhile “?” is
shown after it. At the moment, it is necessary to conduct “Clog remove” or “Backflush” in the “Service” →
“Maintenance” menu.
If the Analyzer have not been used for a long time, after start-up, conduct the replacement of “Lyse”, “Diluent”
and “Detergent” in the “Service” → “Replace”.
8.3 Basic State

Click “Service” button in the main menu and then select “Basic State”, as shown in the figure:
Fig. 8-3-1
(1)Environment temp.: indicates the temperature of the current work environment and the normal temperature
range.
(2)Voltage: indicates current voltage value of WBC aperture volt., RBC aperture volt., 12V, -12V and 5V and
their normal ranges.
8.4 Replace
Click “Replace” in the “Service” menu, as shown in the figure:
67
Fig. 8-4-1
(1)Replace lyse:
If there are bubbles in lyse pipe, or lyse is contaminated or used out, it is necessary to replace the whole bottle
of lyse: click “Lyse” button and thus a prompt shows that “Replacing lyse...”; the replacement is completed
after the schedule bar disappears.
(2)Replace diluent:
If there are bubbles in diluent pipe, or diluent is contaminated or used out, it is necessary to replace the whole
bottle of diluent: click “Diluent” button and thus a prompt shows that “Replacing diluent...”; the replacement is
completed after the schedule bar disappears.
(3)Replace cleaning solution:
When it is necessary to replace the whole bottle of cleaning solution, click “cleaning solution” button and thus
a prompt shows that “Replacing cleaning solution...”; the replacement is completed after the schedule bar
disappears.
8.5 Prime
Click “Prime” in the “Service” menu, as shown in the figure below:
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Fig. 8-5-1
(1)Prime lyse:
When it is necessary to prime lyse after drain-off, click “Lyse” button and thus a prompt shows that “Priming
lyse...”; the priming operation is completed after the schedule bar disappears.
(2)Prime diluent:
When it is necessary to prime diluent after drain-off, click “Diluent” button and thus a prompt shows that
“Priming diluent...”; the priming operation is completed after the schedule bar disappears.
After the priming of diluent and lyse, it is necessary to conduct background test, ensuring that the
results of background test is in normal range, and then sample tests are allowed.
8.6 Rinse
Click “Rinse” in the “Service” menu, as shown in the figure:
69
Fig. 8-6-1
(1)When the background test values of WBC or HGB related parameters are discovered to be abnormal,
conduct the operation of rinsing “WBC pool” and thus a prompt shows that “Rinsing WBC pool...”; the rinsing
operation is completed after the schedule bar is completed.
(2)When the background test values of RBC or PLT related parameters are discovered to be abnormal, conduct
the operation of rinsing “RBC pool” and thus a prompt shows that “Rinsing RBC pool...”; the rinsing
operation is completed after the schedule bar is completed.
(3)In order to prevent sampling parts from contamination which will further disturb the count results, the swab
rinsing operation should be conducted after the Analyzer runs a month.
Conduct the operation of rinsing “Swab” and thus a prompt shows that “Rinsing swab...”; the rinsing operation
is completed after the schedule bar is completed.
8.7 Maintenance
Click “Maintenance” in the “Service” menu, as shown in the figure:
70
Fig. 8-7-1
8.7.1 Drain-off
In the maintenance of the liquid pipeline of the instrument, in order to prevent liquid from sprinkling, it is
necessary to conduct drain-off operation first before maintenance. Take WBC pool drain-off for instance:
(1)Click “WBC pool” button to drain off the liquid in WBC pool and thus a prompt shows that “Draining off
WBC pool...”; the drain-off operation is completed after the schedule bar is completed.
The drain-off operations of “RBC pool”, “Lyse” and “Diluent” are the same as above.
(2)If the Analyzer has not been used for 3-14 days, click the “Pipeline” in Fig. 8-7-1 and thus a prompt shows
that “Please remove reagent!”. Take out pipelines of various reagents from the reagent bottles, click “OK”
button and thus a prompt shows that “Package empty pipe...”; the drain-off operation is completed after the
schedule bar is completed. After liquid in pipeline drains off, put the Analyzer in clean area.
(3)If the Analyzer has not been used for more than 14 days, it is necessary to replace the reagent with distilled
water. Click “Package rinse pipe” in Fig. 8-7-1 and thus a prompt shows that “Package rinse pipe...”; the
rinsing operation is completed after the schedule bar is completed.
Then disconnect distilled water and click “Package empty pipe” button; thus, a prompt shows that “Please
remove reagent!”. Take out pipelines of various reagents from the distilled water, click “OK” button and thus a
prompt shows that “Draining off pipeline...”; the pipeline drain-off operation is completed after the schedule
bar is completed. After the completion of package rinse pipe and package empty pipe operations, put the
Analyzer in clean area.
8.7.2 Aperture
After a long term use of the instrument, aperture may be attached with foreign matters; therefore, it is
necessary to perform clog removal, zap and backflushing functions to remove foreign matters.
Click “Zap” button in Fig. 8-7-1 and a prompt shows “Zapping...” High-voltage DC is applied to the two ends
of the aperture. The zap operation is completed after the schedule bar is completed. The removal of foreign
matters clogged in the aperture can prevent and eliminate WBC and RBC clog faults.
Click “Backflush” button and a prompt shows “Backflushing...” Back flush the aperture. The backflushing
operation is completed after the schedule bar is completed. Cooperated with zap, it can prevent and eliminate
WBC and RBC clog faults.
Click “Clog remove” button and a prompt shows “Removing clog...” The instrument will perform zap and
backflushing functions. The clog removal operation is completed after the schedule bar is completed.
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8.7.3 Soaking
For the accuracy of the Analyzer analysis results, cleaning solutions should be used to soak WBC pool and
RBC pool components under the following circumstances:
(1)When the Analyzer is in clog fault;
(2)When the Analyzer is abnormal in separation.
(1)Soak WBC pool:
Click “WBC pool” button in “Soaking” area in Fig.8-7-1 and a prompt shows “Soaking WBC pool...” After
the soaking, a prompt pops up – “WBC pool soaking is completed. Click Next to continue”. Then click “Next”
and thus a prompt shows “Rinsing WBC pool...”; the WBC pool soaking is completed after the schedule bar is
completed.
(2)Soak RBC pool:
Click “RBC pool” button in “Soaking” area in Fig.8-7-1 and a prompt shows “Soaking RBC pool...”. After the
soaking, a prompt pops up – “RBC pool soaking is completed. Click Next to continue”. Then click “Next” and
thus a prompt shows “Rinsing RBC pool...”; the RBC pool soaking is completed after the schedule bar is
completed.
8.8 Reagent Registration

Click “Register” in the “Service” menu, as shown in the figure:
Fig. 8-8-1
(1)Manually enter barcode information:
Under the circumstance of disconnecting external bar-code scanner, it is allowed to manually enter barcode
information, with operations as below:
Click the input box, correctly enter the barcode on the outer container of reagent packing container(in case of
fault entry, click “Empty” to get rid of the error information and then reenter the barcode), and then click “OK”.
After correct entry, the digitals after the “Remaining number” of various items change accordingly.
Remaining number: remaining number will increase correspondingly after every scanning of barcode
information(be proportional to the volume of reagent bottle).
(2)Enter barcode information by scanning:
Correctly connect the bar-code scanner(the other end of the data line of bar-code scanner is connected to
“USB” interface of the instrument), click the input box after “Barcode”(enable the input to be executable)and
scan the barcode information on the reagent bottle/barrel with bar-code scanner, thus, the screen prompts
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“Registration succeeds”.
(3)Relevant prompts for scan failure:
For manual input or scanning input of barcode, if registration fails, the software will give a prompt –
“Registration fails; wrong barcode input!”. Please check and reenter. If the registration fails again, please
contact with Dirui or agents.
In case of reentering a used barcode, the prompt – “Registration fails; the barcode has been used!”- is given.
Thus, please choose another bottle(or barrel)of reagents to register.
(4)After successful registration of a reagent, please perform the replacement of the corresponding reagent in
“Service” → “Replace” interface.
When the system is working, do not look directly at the light beam from the bar-code scanner. It may
hurt your eyes.
8.9 Device Detection

Click “Page” button and select “Device Detect” in the “Service” menu; thus, the display is shown as following
figure:
Fig. 8-9-1
8.9.1 Motor Detection

In case of faults in movement parts, it is allowed to determine faults through the detection on motor. Motor
detection includes: detection of X axis motor, Y axis motor, diluent motor and whole blood motor. Click the
“test” button after the corresponding motor and the test results will be displayed in the screen(“Succeed” or
“Fail”).
Notes:
Faults include motor fault, optocoupler fault, line fault, etc.
8.9.2 Valve Detection
Faults in valves will lead to the abnormal work of the Analyzer and valve detection is an importance mean to
eliminate faults in liquid pipelines. Operation processes are as below:
Click the corresponding number of a certain valve(SV1~SV14)and the Analyzer will automatically detect the
valve. After clicking, the sound of valve opening should be heard, which indicates the valve is in normal work
status.
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8.9.3 Pump Detection

Open the left side door, and click “Positive pressure” or “Negative pressure” to observe whether the operation
of positive or negative pressure pump is normal.
8.10 HGB Check

Click “HGB Check” in the “Service” menu, as shown in the figure:
Fig. 8-10-1
Click “Check” in the figure and the box after the “Check” will show the HGB check value.
8.11 Counter
Click “Counter” in the “Service” menu, as shown in the figure:
Fig. 8-11-1
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Check operation times of injectors of sample, test, diluent, lyse, as well as the operation duration of negative
pump and HGB luminotron(unit: min).
8.12 Version Information

Click “Version Info.” in the “Service” menu, as shown in the figure:
Fig. 8-12-1
It is allowed to check version information, such as mainboard software, mainboard algorithm library, control
software and printer software. After the upgrade of program, these version information will upgrade
accordingly.
8.13 Device Information

Click “Device Info.” in the “Service” menu, as shown in the figure:
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Fig. 8-13-1
Before delivery, the instrument has been set with ID. User can only examine the instrument ID and cannot
change it.
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Chapter 9 Alarm Information and Processing

The chapter introduces various possible faults of the Analyzer, analyzes causes that may lead to faults and
provides corresponding processing methods.
Sample analysis under circumstances with faults may produce incorrect analysis results. During the
sample analysis, in case of fault alarms, it is a must to eliminate the faults first.
In case of faults, the Analyzer will display alarm information in the fault information area. Click “Fault Info.”
button in the main menu, as shown in the figure:
Fig. 9-1-1
The fault info. will be displayed by fault order. The latest fault will be displayed at the topside.
After selecting a specific fault information, click “Clear” button to eliminate the fault information.
After selecting a specific fault information, click “Details” button to check its error time and error type, as
shown in the figure:
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Fig. 9-1-2
The fault info. will be displayed by fault order. The latest fault will be displayed at the topside.
After selecting a specific fault information, click “Details” button to check its error information.
Error information includes: device fault and software fault. Device fault can be cleared and software
fault can only be examined and cannot be cleared.
9.2 Alarm Information

During the use of Analyzer, in case of any faults in the following table, please refer to relevant fault processing
steps; in case of failure to clear certain faults, please contact the After-sales Service Department of Dirui.
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Alarm code Alarm class Alarm description

E00002 Stop No diluent
E00003 Stop No lyse
E00004 Stop Y-axis motor error
E00005 Stop X-axis motor error
E00006 Stop Diluent motor error
E00007 Stop Sample aspirating motor error
E00008 Stop Y-axis motor sensor error
E00009 Stop X-axis motor second sensor error
E00010 Stop X-axis motor first sensor error
E00011 Stop Diluent motor sensor error
E00012 Stop Sample aspirating motor sensor error
E00014 Warning Room temperature sensor fails to connect.
E00015 Warning Room temperature is too high
E00016 Warning Room temperature is too low
E00017 Stop Side door opens
E00018 Stop Voltage of WBC aperture is out of range
E00019 Stop Voltage of RBC aperture is out of range
E00020 Stop 12V is out of range
E00023 Stop Background of HGB is out of range
E00024 Stop Negative pressure error
E00025 Stop Pressure is too low
E00026 Stop Pressure is too high
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Chapter 10 Transportation and Storage
10.1 Transportation Requirements

In the transportation, the instrument should be damp-proof, water proofed and avoid being vibrated or extruded
strongly; the ambient temperature is -40oC~55oC; the relative humidity should be 30%~85% and the
atmospheric pressure be 75 kPa~106 kPa.
During transportation, the instrument should be kept upright and the identification requirements on the outer
box should be met. The Analyzer should be held and put gently in handling and loading and unloading.
10.2 Storage Requirements

The instrument should be stored in indoor environment without chemicals and corrosive gases and with good
ventilation and should be clean, with an altitude lower than 2000m, temperature between -40°C and 55°C,
relative humidity not more than 75% and atmospheric pressure should be 75 kPa~106 kPa.
80
Appendix A Communication Interface Protocol V2.0

A.1 The Protocol is used to transmit information between BCC-3600 Hematology Analyzer and LIS. It is
based on specifications of HL7 which is in Version 2.4.
A.2 Glossary
Message header(MSH): every kind of message header is used to define massage objective and usage and every
massage consists of several massage segments. The first segment in a message is always a message head
segment, indicating the sending and receiving program name, massage type and a unique massage ID, and the
following segments are determined by massage type. For example, the message of a sample is transmitted with
Segment Type OBR and another detection result message is transmitted with several OBX segments.
Segment: every massage segment consists of several groups of data fields and every massage segment has a
specific name which is used to define its detail or function. For example, Message Header (MSH), patient
identification (PID) and patient visit (PV1).
Data field: a massage segment is divided by several data fields. Different data fields are separated by field
separator.
<SB>dddd <EB><CR>
<SB>: massage start character(1 byte). ASCII character <VT>, i.e. 0x0B.
dddd: data(formed with characters with various length). This is the HL7 data content of the block. Data can
contain any single byte value containing more than 0x1F in hexadecimal and enter in ASCII code, <CR>.
<EB>: massage end character(1 byte). ASCII character <FS>, i.e. `0x1C.
<CR>: Enter(1 byte).ASCII character <CR>, i.e.,0x0D.
For example:
MSH|^~\&|BCC3600||||20100419104618||ORU^R01|361|P|2.4||||| CHN|UTF8<cr>
<EB><CR>
Where:
The five-character definition after MSH is used to distinguish separators of each segment, component and
subcomponent. Although these characters can be any non-textual characters, the characters in the following
table are recommended in HL7 standard specification:
Delimiter Value
Field delimiter |
Component delimiter ^
Subcomponent delimiter &
Repetition delimiter ~
Escape character \
A.3 Massage segments used in the protocol

a) MSH -Message header
b) PID-Patient Identification
c) PV1-Patient Visit
d) OBR-Observation Request
e) OBX-Observation/Result
f) NDS-Notice Details
g) MSA-Massage Acknowledge
A.4 Duplex Communication Process
Instrument directly sends inspection results to LIS, such as sample information:
As showed in the figure
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A.5 HL7 Attribute Table

Massage segments used in the protocol can be mandatory, optional and repeatable.
Schematic Diagram of Inspection Result and QC Data Communication Process
MSH definition table:
MSH –Massage Header: the massage segment is mandatory, including such basic information of HL7
massages as message delimiter value, massage type and massage encoding, and it is the first massage segment
of every HL7.
MSH|^~\&|BCC3600||||Sending time||Massage type|Massage control ID|Process ID|2.4|||||CHN|UTF8<cr>
Example:
MSH|^~\&|BCC3600||||20100419104618||ORU^R01|361|P|2.4||||| CHN|UTF8<cr>
HL7
No. Field name Length suggested Instructions Example
length
Including the first field separator following the
Field
1 1 1 massage segment name, used to specify field |
separator
separator value of the rest part of the massage.
Encoding Including component delimiter, repetition
2 4 4 ^~\&
character delimiter and subcomponent delimiter.
Sending
Sending terminal application
3 terminal 7 180 BCC3600
Value: BCC3600
program
Massage creation time(format:
YYYY[MM[DD[HH[MM[SS]]]]]), applying
Sending 20080419104
7 14 26 the system time.
time 618
Note: during transmitting L-J/X-BAR QC data
for same lot file No., the time should be same
Massage type, format as “Massage TypeÊvent
Type”,
with value: ORU^R01(sample)
ACK^R01(Sample identification)
OUL^R21(QC)
Message ACK^R21(QC confirmation)
9 7 7 ORU^R01
type EANÛ09(Device fault information)
ACKÛ09(Device fault information
confirmation)
EARÛ08(Test connection information)
ACKÛ08(Test connection information
confirmation)
Informatio
Information control ID, used to uniquely
10 n control 20 20 361
identify a message. Value: PID
ID
The field is used to determine whether to
process the massage defined according to the
11 Process ID 3 3 P
process rule pf HL7 application program(the
seventh layer). Value: P
HL7 HL7 version adopted in the protocol. Value:
12 3 60 2.4
version 2.4
Country
17 3 3 Country code identification, value:CHN CHN
code
Character International character standard of ISO/IEC
18 10 10 UNICODE
set 10646-1-1993, value: UNICODE
82
PID definition table:

PID –Patient identification: the massage segment is optional, used for patient sample transmission, including
case No., name, age, gender, etc.
PID||Case No.|||Name|||Gender|<cr>
Example:
PID||1234567890|||Wang Sanqiang|||Male|<cr>
HL7 suggested
No. Field name Length Instructions Example
length
Patient identification, here used as
2 Case No. 20 20 1234567890
patient's case No.
5 Name 50 250 Patient name Wang Sanqiang
Gender, represented by character
8 Sex 10 1 Male
string
PV1 definition table:

PV1 –Patient visit: the massage segment is optional, used for patient sample transmission, including expense,
department, bed No., etc.
PV1||Expense|Department^^Bed No.|<cr>
Example:
PV1||Self pay|Outpatient^^235689|<cr>
HL7 suggested
length
2 Expense 80 80 Patient's expense information Self pay
Indicate patient
3 80 80 Format: Department^^bed No. Outpatient^^235689
position
OBR definition table:

OBR –Observation request: the massage segment is optional and mainly includes such observation requests as
sample No., scan No., tube rack, deliver time for test, etc.
OBR||Sample No.|Scan No.|||Sampling time|Count time|||||||Deliver time for test||||Tube rack|Tube No.<cr>
Example:
OBR||23|31C3F010230DFB03|||20071207080000||||||||20071207083000||||2|3<cr>
HL7 suggested
length
Be sample No. in sample test
2 Sample No. 16 22 23
Be file No. in LJ/X QC
Barcode ID in sample test
3 Scan No. 32 22 31C3F010230DFB03
Lot No. in LJ/X QC
QC service identifier, used to
Data service identify different QC count
4 200 200 L-J
type result type. Value: L-J, X-Bar,
X-B
Be sampling time in sample
Sampling
6 14 26 test
time
Be validity in LJ/X QC
Be count time in sample
information
7 Count time 14 26
Be count time in LJ/X QC
Be count time in X-B QC
Time for
14 14 26 Time for sampling
sampling
18 Tube rack 2 60
19 Tube No. 2 60
83
OBX definition table:

OBX –Observation/result: the massage segment is repeatable and mainly includes all test result parameter
information and sample measurement mode, analysis mode, parameter set, etc.
OBX|Serial number ID|Data type| ID^Name ||Test result, histogram data, original data...|Unit|Test result
reference|Abnormal value|||F<cr>
Example:
OBX|6|NM|3005^RBC||4.63|10*9/L|11.00-12.00||||F<cr>
HL7 suggested
length
Serial Used to identify different OBX massage
1 10 10 1
number ID segments in massage.
Data type of test result, value: “ST”, “NM”,
2 Data type 3 3 ED
“ED”, “IS”, etc.
Test item identification.Format is
“ID^Name”, with ID as the test item
identification and name as test item
description information.See Identifier
3 Identifier 250 250 Encoding Definition attached for encoding
values of all test items. Note: ID is used to
uniquely identify a test parameter and name is
mainly used for description and cannot be
identifier.
Test result data, which can be digital,
Test result,
character string, enum value, binary data, etc.
histogram
See Enum Type Table for detailed data values.
data, 655
5 65536 (Histogram and original data are waveform
original 36
data with multiple channels and consisting of
data, QC
256 elements which are separated by repeat
level...
mark “~”)
Unit. Note: for “^” in unit conflicts with
6 Unit 10 250 10*9/L
component delimiter, replace it by “*”
Test result Test result range, format as: “Reference lower 12.463-33.5
7 20 60
reference limit - Reference upper limit” 69
Abnormal
8 1 1 Test result mark, e.g. “H” and “L” H
value
Test result Test result status. Value is “F” -
11 20 20 F
status (Final Result), indicating the final result.
NDS definition table:

NDS -Notice details: the massage segment is repeatable, transmitting details of test device fault information.
NDS|Process status|Fault occurring time|Primary key|Code No.<cr>
Example:
NDS|0|199806300800|2|20003<cr>
HL7 suggested
length
Process or Process status, with value: 0 - processed
1 1 20 0
not 1 - Not processed
2 Fault time 14 26 Fault time
3 Fault ID 14 26 Primary key
Code No. format: Code No. -ID, e.g. 20003.
4 Code No. 250 20003-1
See Fault Information Coding Schedule.
MSA definition table:

MSA –Massage acknowledge: the massage segment contains massage acknowledge.
Example:
MAS|AA<cr>
84
HL7 suggested
length
Message Acknowledge codes: “AA” - Accept,
1 Code AA
confirmation “AE” - Error, and “AR” - Reject.
Appendix:
The protocol adopts user-defined encoding.
Enum Type Table
Data Items Value
0- Whole blood
Measurement mode 1- Prediluted
2- Automatic whole blood
0- Common
1- Male adult
2- Female adult
3- Child
4- Newborn
Reference group
5-User-defined 1
6-User-defined 2
7-User-defined 3
8-User-defined 4
9-User-defined 5
0- High
L-J/X QC level 1- Middle
2- Low
OBX-3 Identifier Encoding Definitions

Code Name Instructions Value type OBX-3 field
3001 MODE Measurement mode IS 3001^MODE
3002 Ref Reference group IS 3002^Ref
3003 Age Age NM 3003Âge
3004 Level L-J/X QC level IS 3004^Level
3005 WBC Total WBCs NM 3005^WBC
3006 LYM# Total minicells in WBC NM 3006^LYM#
Total intermediate cells in
3007 MXD# NM 3007^MXD#
WBC
3008 NEUT# Total maxicells in WBC NM 3008^NEUT#
3009 LYM% Minicell ratio in WBC NM 3009^LYM%
3010 MXD% Intermediate cell ratio in WBC NM 3010^MXD%
3011 NEUT% Maxicell ratio in WBC NM 3011^NEUT%
3012 RBC Total RBCs NM 3012^HGB
3013 HGB Hemoglobin concentration NM 3013^RBC
3014 HCT Hematocrit NM 3014^HCT
3015 MCV Mean corpuscular volume NM 3015^MCV
3016 MCH Mean corpuscular hemoglobin NM 3016^MCH
Mean corpuscular hemoglobin
3017 MCHC NM 3017^MCHC
concentration
Red blood cell distribution
3018 RDW-SD NM 3018^RDW-CV
width standard deviation
85
Code Name Instructions Value type OBX-3 field

Red cell distribution width -
3019 RDW-CV NM 3019^RDW-SD
coefficient of variation
3020 PLT Total platelet NM 3020^PLT
3021 PCT Platelet hematocrit NM 3021^MPV
3022 MPV Mean platelet volume NM 3022^PDW
Platelet volume distribution
3023 PDW NM 3023^PCT
width
Middle and large platelets ratio
3024 P-LCR NM 3024^P_LCR
in platelet
3025 P_LCC Platelet large cell count NM 3025^P_LCR#
RBC
3026 256 RBC histogram data MA 2026^RBC Histogram.MA
Histogram.MA
PLT Histogram.
3027 256 PLT histogram data MA 2027^PLT Histogram.MA
MA
WBC Histogram. 2028^WBC
3028 256 WBC histogram data MA
MA Histogram.MA
3029 RBC RAW.MA 256 RBC original data MA 2029^RBC RAW.MA
3030 PLT RAW.MA 256 PLT original data MA 2030^PLT RAW.MA
3031 WBC RAW.MA 256 WBC original data MA 2031^WBC RAW.MA
3032 Anisocytosis Unequal corpuscular volume NM 3032Ânisocytosis
3033 Microcytosis Parvicellular red blood cell NM 3033^Microcytosis
3034 Macrocytosis Macrocytic red blood cell NM 3034^Macrocytosis
3035 Hypochromia Hypochromia NM 3035^Hypochromia
3036 Anemia Anemia NM 3036Ânemia
3037 Erythrocytosis Erythrocytosis NM 3037Êrythrocytosis
3038 Thrombocytopenia Thrombocytopenia NM 3038^Thrombocytopenia
3039 Thrombocytosis Thrombocytosis NM 3039^Thrombocytosis
3040 WBCDecrease WBC Decrease NM 3040^WBCDecrease
3041 WBCIncrease WBC Increase NM 3041^WBCIncrease
3042 LYMDecrease Lymphocyte decrease NM 3042^LYMDecrease
3043 LYMIncrease Lymphocyte increase NM 3043^LYMIncrease
3044 NEUDecrease NEU Decrease NM 3044^NEUDecrease
3045 NEUIncrease NEU Increase NM 3045^NEUIncrease
Example of complete massage segments:

1. Send from device-side to host computer(LIS)
1)Patient sample
<SB>MSH|^~\&|BCC3600||||20100419104618||ORU^R01|1|P|2.4||||| CHN|UNICODE <cr>
OBR||23|31C3F010230DFB03|||20071207080000|20071207160000|||||||20071207083000||||2|3<cr>
OBX|1|IS|3001^MODE||0||||||F<cr>
OBX|2|IS|3002^Ref||0||||||F<cr>
OBX|3|NM|3003Âge||17|Age|||||F<cr>
86
OBX|4|NM|3005^WBC||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|5|NM|3006^LYM#||1914|10*9/L|36.65-98.65|H|||F<cr>
OBX|6|NM|3007^MXD#||95|10*9/L|3.65-8.7|H|||F<cr>
OBX|7|NM|3008^NEUT#||3.4|10*9/L|2.66-6.36||||F<cr>
OBX|8|NM|3009^LYM%||90|%|2.5-6.4|H|||F<cr>
OBX|9|NM|3010^MXD%||123|%|79-98.4|H|||F<cr>
OBX|10|NM|3011^NEUT%||33.456|%|57-59.5|L|||F<cr>
OBX|11|NM|3012^RBC||34.444|10*12/L|4.93-36.3||||F<cr>
OBX|12|NM|3013^HGB||3|g/L|46-69|L|||F<cr>
OBX|13|NM|3014^MCV||45.2|fL|121.4-264.5|L|||F<cr>
OBX|14|NM|3015^MCH||8.9|fmol|90.6-96.5|L|||F<cr>
OBX|15|NM|3016^MCHC||0|g/L|68-124|L|||F<cr>
OBX|16|NM|3017^RDW_CV||1282|%|59.6-98.7|H|||F<cr>
OBX|17|NM|3018^RDW_SD||2.2|fL|37-39.7|L|||F<cr>
OBX|18|NM|3019^HCT||18333|L/L|54.545-96.546|H|||F<cr>
OBX|19|NM|3020^PLT||121740000|/nL|60-61|H|||F<cr>
OBX|20|NM|3021^MPV||45.2|um*3|5-26.7|H|||F<cr>
OBX|21|NM|3022^PDW||2.2|fL|23.6-98.2|L|||F<cr>
OBX|22|NM|3023^PCT||3.5|%|13.655-56.245|L|||F<cr>
OBX|23|NM|3024^P_LCR||0|%|123.5-254.7|L|||F<cr>
OBX|24|NM|3025^P_LCR#||0|%|123.5-254.7|L|||F<cr>
OBX|25|MA|3026^RBC Histogram.MA||N 0~ N1~ N2~ N3~ N4~ N5……~ N255||||||F<cr>
OBX|26|MA|3027^PLT Histogram.MA||N 0~ N1~ N2~ N3~ N4~ N5……~ N255||||||F<cr>
OBX|27|MA|3028^WBC Histogram.MA||N 0~ N1~ N2~ N3~ N4~ N5……~ N255||||||F<cr>
OBX|28|MA|3029^RBC RAW.MA||R0~ R1~ R2~ R3~ R4~ R5……~ R255||||||F<cr>
OBX|29|MA|3030^PLT RAW.MA||R 0~ R1~ R2~ R3~ R4~ R5……~ R255||||||F<cr>
OBX|30|MA|3031^WBC RAW.MA||R 0~ R1~ R2~ R3~ R4~ R5……~ R255||||||F<cr>
OBX|31|NM|3032Ânisocytosis||0||||||F<cr>
OBX|32|NM|3033^Microcytosis||0||||||F<cr>
OBX|33|NM|3034^Macrocytosis||0||||||F<cr>
OBX|34|NM|3035^Hypochromia||0||||||F<cr>
OBX|35|NM|3036Ânemia||0||||||F<cr>
OBX|36|NM|3037Êrythrocytosis||0||||||F<cr>
OBX|37|NM|3038^Thrombocytopenia||0||||||F<cr>
OBX|38|NM|3039^Thrombocytosis||0||||||F<cr>
OBX|39|NM|3040^WBCDecrease||0||||||F<cr>
OBX|40|NM|3041^WBCIncrease||0||||||F<cr>
OBX|41|NM|3042^LYMDecrease||0||||||F<cr>
OBX|42|NM|3043^LYMIncrease||0||||||F<cr>
OBX|43|NM|3044^NEUDecrease||0||||||F<cr>
OBX|44|NM|3045^NEUIncrease||0||||||F<cr>
<EB><CR>
Return to Message Confirmation
<SB>MSH|^~\&|LIS||||20100419104618||ACK^RO1||P|2.4|||||CHN|UNICODE<cr>
87
MSA|AA<CR>
<EB><CR>
2)QC
2.1)L-J/X-Bar QC
<SB>MSH|^~\&|BCC3600||||20100419104618||OUL^R21|1|P|2.4||||| CHN|UNICODE <cr>
OBR||1|200908|L-J||20071207080000|20071207160000||||||||||||<cr>
OBX|1|IS|3004^Level||0||||||F<cr>
OBX|2|NM|3005^WBC||4.63||||||F<cr>
OBX|3|NM|3006^LYM#||1914||||||F<cr>
OBX|4|NM|3007^MXD#||95||||||F<cr>
OBX|5|NM|3008^NEUT#||3.4||||||F<cr>
OBX|6|NM|3009^LYM%||90||||||F<cr>
OBX|7|NM|3010^MXD%||123||||||F<cr>
OBX|8|NM|3011^NEUT%||33.456||||||F<cr>
OBX|9|NM|3012^RBC||34.444||||||F<cr>
OBX|10|NM|3013^HGB||3||||||F<cr>
OBX|11|NM|3014^MCV||45.2||||||F<cr>
OBX|12|NM|3015^MCH||8.9||||||F<cr>
OBX|13|NM|3016^MCHC||0||||||F<cr>
OBX|14|NM|3017^RDW_CV||1282||||||F<cr>
OBX|15|NM|3018^RDW_SD||2.2||||||F<cr>
OBX|16|NM|3019^HCT||183||||||F<cr>
OBX|17|NM|3020^PLT||121||||||F<cr>
OBX|18|NM|3021^MPV||45.2||||||F<cr>
OBX|19|NM|3022^PDW||2.2||||||F<cr>
OBX|20|NM|3023^PCT||3.5||||||F<cr>
OBX|21|NM|3024^P_LCR||0||||||F<cr>
OBX|22|NM|3025^P_LCR#||0||||||F<cr>
OBX|23|MA|3026^RBC Histogram.MA||N 0~ N1~ N2~ N3~ N4~ N5……~ N255||||||F<cr>
OBX|24|MA|3027^PLT Histogram.MA||N 0~ N1~ N2~ N3~ N4~ N5……~ N255||||||F<cr>
OBX|25|MA|3028^WBC Histogram.MA||N 0~ N1~ N2~ N3~ N4~ N5……~ N255||||||F<cr>
<EB><CR>
<SB>MSH|^~\&|LIS||||20100419104618||ACK^R21||P|2.4|||||CHN|UNICODE<cr>
MSA|AA<CR>
<EB><CR>
2.2)X-B QC
<SB>MSH|^~\&|BCC3600||||20100419104618||OUL^R21|1|P|2.4||||| CHN|UNICODE <cr>
OBR||||X-B|||20071207160000||||||||||||<cr>
OBX|11|NM|3014^MCV||45.2||||||F<cr>
OBX|12|NM|3015^MCH||8.9||||||F<cr>
OBX|13|NM|3016^MCHC||20||||||F<cr>
<EB><CR>
88
<SB>MSH|^~\&|LIS||||20100419104618||ACK^R21||P|2.4|||||CHN|UNICODE<cr>
MSA|AA<CR>
<EB><CR>
3)Instrument fault information
<SB>MSH|^~\&|BCC3600||||20100419104618||EANÛ09||P|2.4|||||CHN|UTF8<cr>
NDS|0|201206300800|1|20001<cr>
NDS|1|201206300800|2|20002<cr>
NDS|0|201206300800|3|20003<cr>
NDS|0|201206300800|4|20004<cr>
...
<EB><CR>
<SB>MSH|^~\&|LIS||||20100419104618||ACKÛ09||P|2.4|||||CHN|UTF8<cr>
MSA|AA<CR>
<EB><CR>
4)Equipment connection test
<SB>MSH|^~\&|BCC3600||||20100419104618||EARÛ08||P|2.4|||||CHN|UTF8<cr>
<EB><CR>
Message confirmation
<SB>MSH|^~\&|LIS||||20100419104618||ACKÛ08||P|2.4|||||CHN|UTF8<cr>
MSA|AA<CR>
<EB><CR>
2. Send from host computer(LIS)to device-side
1)Worksheet
<SB>MSH|^~\&|LIS||||20100419104618||ORU^R01|1|P|2.4|||||CHN|UTF8<cr>
OBR||23|31C3F010230DFB03|||20071207080000||||||||20071207083000||||2|3<cr>
OBX|1|IS|3001^MODE||0||||||F<cr>
OBX|2|IS|3002^Ref||0||||||F<cr>
OBX|3|NM|3003Âge||17||||||F<cr>
<EB><CR>
<SB>MSH|^~\&|BCC3600||||20100419104618||ACK^RO1||P|2.4|||||CHN|UTF8<cr>
MSA|AA<CR>
<EB><CR>
2)Equipment connection test
<SB>MSH|^~\&|LIS||||20100419104618||EARÛ08||P|2.4|||||CHN|UTF8<cr>
<EB><CR>
<SB>MSH|^~\&|BCC3600||||20100419104618||ACKÛ08||P|2.4|||||CHN|UTF8<cr>
MSA|AA<CR>
<EB><CR>
89
Appendix B Warranty
Dear customers:
Thank you for your purchase of BCC-3600 Hematology Analyzer. The following services are guaranteed:
(1)Technical consultations provided at any time.
(2)Maintenance free of charge within a year from the day you purchase the instrument.
(3)Paid services in the following conditions:
a)The warranty period for the product has been expired.
b)Damage caused by accidents or improper use.
c)Damage caused due to failure to use according to User Manual.
d)Damage caused due to self-repair unauthorized by our company.
(4)With the development of technology, we will supply upgrade service for Hematology Analyzer.
If you need any technical support, please contact us according to the following address and telephone:
Manufacturer:DIRUI INDUSTRIAL CO.,LTD.
Address for headquarters:
3333 Yiju Street,New&High Tech. Development Zone Changchun,Jilin 130103,P.R.China
Address for factory:
95 Yunhe Street,New&High Tech. Development Zone Changchun,Jilin 130012,P.R.China
Website:http://www.dirui.com.cn
E-mail:dirui@dirui.com.cn
Telephone for complaint: +86(431)81935326 85177245
Fax: +86(431)85173354
International customer service hotline:+86(431)81935329 85100409

International fax:+86(431)85172581 85083741
International customer service e-mail:service@dirui.com.cn
Domestic customer service hotline:4008116695 4008116605

Domestic fax: +86(431)85100405
Domestic customer service e-mail:service.ch@dirui.com.cn
90
Appendix C Product Description
C.1 Product Categories

The product is described according to the following categories:
(1)Categories classified according to medical apparatus and instruments:
Belonging to the blood analysis system in clinic test analysis instruments(6840), with Class II management
class.
(2)Classified according to protection against electric shock:
Belonging to Class I device.
C.2 Product Supporting Reagents

(1)Diluent
(2)Lyse
(3)Cleaning solution
C.3 Consumption of Product Supporting Reagents

Operation Operation
Reagent consumption Reagent consumption
Instruction Instruction
System sleep Diluent (22±1)mL Diluent (56±2)mL
Soak WBC Cleaning
System wake up Diluent (22±2)mL (3±0.2)mL
solution
Diluent (88±5)mL Diluent (56±2)mL
Start up Soak RBC Cleaning
Lyse 1 mL (3±0.2)mL
solution
Diluent (84±10)mL Diluent (53±2)mL
Power off Cleaning Rinse swab Cleaning
6 mL 0.75mL
solution solution
Restart Diluent (58±1)mL Rinse WBC Diluent (16±1)mL
Diluent (110±2)mL Rinse RBC Diluent (16±1)mL
Cleaning
Rinse device (6±0.2)mL Clog remove Diluent (29±1)mL
solution
Backflush Diluent (29±1)mL
Operation Fill and rinse the tube with Operation Fill and rinse the tube with
Instruction required dose Instruction required dose
Replace
Replace Lyse (11±1)mL Diluent (90±5)mL
diluent
lyse
Diluent (8±1)mL Prime diluent Diluent (102±2)mL
Replace Diluent (29±2)mL Prime lyse Lyse (9.5±1)mL
cleaning Cleaning
solution 1.5 mL
solution
Dosage consumed per test

Diluent (28±2)mL
Lyse 1 mL
C.4 Parameter Descriptions

Parameters obtained in histogram
91
Item Abbreviations Default unit
Lymphoma percentage LYM% %
Mixed cell percentage MXD% %
Neutrophils percentage NEUT% %
Mean corpuscular volume MCV fL

RDW-CV %
coefficient of variation
RDW-SD fL
standard deviation
Mean platelet volume MPV fL
Platelet distribution width PDW %
Parameters obtained in calculation

Item Abbreviations Default unit
Lymph count LYM# 109/L
Mixed cell count MXD# 109/L
Neutrophil count NEUT# 109/L
Hematocrit HCT L/L
Mean corpuscular hemoglobin MCH pg
Mean corpuscular hemoglobin
MCHC g/L
concentration
Platelet hematocrit PCT %
92

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Description

Version number: REV. 07-2013.

● Do not directly contact the blood preparation of patient.

● Do not use disposable goods for second time.

● The Analyzer should be operated in a good grounding condition.

● Confirm that input voltage is qualified. Use specified fuse box.

● Confirm that Analyzer switch is on [O] before power on.

● Do not use the Analyzer under inflammable and explosive conditions.

● Do not contact the moving parts to avoid accidents during test.

Dirui reserves the right of final interpretation of this User Manual.

● Relevant electrical equipment are in line with national standards.

● The operations of Analyzer are in strict accordance with the specifications.

Chapter 6 Conventional Operation............................................................................................. 45

1.1 General Description

1.2 Technical Specifications

White blood cell histogram WBC Histogram

1.3 Operating Principle

Whole blood sample 6 μL

Sample of diluent ratio being about

Lyse 1 mL Diluent about 2.6 mL

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

Fig.1-3-1 Diluent Process under Whole Blood Working Mode

20 μL peripheral blood sample

Sample of diluent ratio being

Sample of diluent ratio being

WBC sample of diluent ratio RBC/PLT sample of diluent

Fig.1-3-2 Diluent Process under Pre-diluent Working Mode

1.3.3 WBC/HGB Measurement

Fig.1-3-4 Schematic Diagram for Counting

white blood cell.

Fig.1-3-5 Schematic Diagram for Counting

1.3.4.3 Red cell parameters

1.4 Structure of the Analyzer

1 Touch screen 2 Printer 3 Biological hazards identification

1.4.2 Rear View

1.5 External Equipment

1.6 Soft Keyboard

0~9: input figurers.

Only for “In Vitro Diagnostic” use

Instrument conforms to the in vitro diagnosis device directive of EU

Refer to the accompanying documents

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

2.1 Installation requirements

2.3 Installation Steps

2.3.2 Connection of External Pipelines

Please confirm to the related local regulations on medical waste disposal.

Ensure reliable earthing of socket connected with the power line.

2.3.7 Initial Starting-up

3.1 General Description

3.2 Unit Set

Testing items Unit Numeric form Remarks

10^9/L ***.** Default unit

LYM#, MXD#, NEUT# 10^9/L ***.** Default unit

LYM%, MXD%, NEUT% % **.* Default unit

10^12/L **.** Default unit

g/L *** Default unit

HGB g/dL **.*

fL ***.* Default unit

pg **.* Default unit

10^9/L *. Default unit

LYM#, MXD#, NEUT# 10^9/L *. Default unit

10^12/L . Default unit

P-LCR % . Default unit

P-LCC 10^9/μL . Default unit