Hematology Analyzer: Operation Manual

Operation Manual Edition:B/01
Hematology Analyzer
Operation Manual
1
Operation Manual Edition: B/02
Chapter 1 Instrument Introduction ..................................................................................... 7

1.1 Name ......................................................................................................................... 7
1.2 Structure .................................................................................................................... 7
1.2.1 Host ............................................................................................................... 7
1.2.2 Accessory ...................................................................................................... 7
1.3 Purpose...................................................................................................................... 7
1.4 Specifications ....................................................................................................... 8
1.5 Structure .................................................................................................................. 12
1.5.1 Front Panel .................................................................................................. 12
1.5.2 Rear panel ................................................................................................... 13
1.6 Operation ................................................................................................................. 13
1.7 Detection Principle ................................................................................................... 17
1.7.1 Detection Principles of WBC, RBC, PLT ..................................................... 17
1.7.2 Principles of HGB Measurement ................................................................. 17
1.7.3 Volume Distribution of Blood Cell ................................................................ 17
1.7.4 Results and Calculation of Parameter Measurement ............................... 18
Chapter 2 Installation ......................................................................................................... 19
2.1 Package ................................................................................................................... 19
2.2 Unpack ..................................................................................................................... 19
2.3 Installation Requirements ........................................................................................ 19
2.3.1 Installation Environment .............................................................................. 19
2.3.2 Space Requirement ..................................................................................... 19
2.3.3 Power Requirement ..................................................................................... 19
2.4 Reagent tubing connection ...................................................................................... 20
2.4.1 Lyse Connection .......................................................................................... 20
2.4.2 Diluent Connection ...................................................................................... 20
2.4.3 Waste Connection ....................................................................................... 20
2.5 Recorder Paper Installation ..................................................................................... 21
2.6 Printer Installation (Optional) ................................................................................... 21
2.7 Power Cable Connection ......................................................................................... 21
Chapter 3 Sample Analysis ................................................................................................ 22
3.1 Preparation Before Startup ...................................................................................... 22
3.2 Startup...................................................................................................................... 22
3.2.1 Sample Mode ............................................................................................ 23
3.3 Background Test...................................................................................................... 24
3.4 Quality Control ......................................................................................................... 25
3.5 Preparation for sample collection ............................................................................ 25
3.5.1 Whole Blood Blood Collection ....................................................................... 25
3.5.2 Peripheral Blood Collection ........................................................................... 25
3.5.3 Prepare Samples in Prediluted Mode ....................................................... 25
3.5.4 Prepare Samples in Peripheral Mode ........................................................... 26
3.5.5 Sample Homogenization ............................................................................... 26
3.6 Sample count and Analysis ..................................................................................... 27
3.6.1 Input Sample Information ............................................................................ 27
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3.6.2 Procedures of Sample Count and Analysis ................................................. 27

3.6.3 Parameter Alarm.......................................................................................... 28
3.7 Shutdown ................................................................................................................. 28
Chapter 4 Quality Control .................................................................................................. 29
4.1 Edit Quality Control Files ......................................................................................... 29
4.2 Quality Control Run ................................................................................................. 30
4.3 Quality Control Graph .............................................................................................. 31
Chapter 5 Calibration .......................................................................................................... 33
5.1 Operator calibration ................................................................................................. 33
5.1.1 Background Test ....................................................................................... 33
5.1.2 Assurance of Repeatability ....................................................................... 33
5.1.3 Calculate Calibration Factors .................................................................... 34
5.1.4 Modify the Calibration Coefficient ............................................................. 34
5.2 Auto Calibration ................................................................................................. 35
Chapter 6 Setup .................................................................................................................. 38
6.1 Print .................................................................................................................... 38
6.2 Date Time .......................................................................................................... 39
6.3 Cal factor ............................................................................................................ 39
6.4 Auto maintain ..................................................................................................... 40
6.5 Doctor setting ..................................................................................................... 40
6.6 Operator setting ................................................................................................. 42
6.7 Ref range ........................................................................................................... 42
6.8 Para unit ............................................................................................................. 43
6.9 Gain.................................................................................................................... 44
6.10 Transmit ............................................................................................................. 45
Chapter 7 Review ................................................................................................................ 46
7.1 Sample search ................................................................................................... 46
7.2 Sample edit ........................................................................................................ 48
7.3 Sample delete .................................................................................................... 48
7.4 Sample export .................................................................................................... 48
7.5 Sample print ....................................................................................................... 49
7.6 Sample transmit ................................................................................................. 49
Chapter 8 Maintain ................................................................................................................ 50
8.1 Flush .................................................................................................................. 50
8.2 Enhanced Flush ................................................................................................. 50
8.3 Cleaning ............................................................................................................. 50
8.4 Prime Chambers ................................................................................................ 50
8.5 Drain Chambers ................................................................................................. 51
8.6 Drain All ............................................................................................................. 51
8.7 Prime Dilutent .................................................................................................... 51
8.8 Prime Lyse ......................................................................................................... 51
8.9 Prime .................................................................................................................. 51
8.10 Init ...................................................................................................................... 51
8.11 Shutdown ........................................................................................................... 51
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8.12 Screen ................................................................................................................ 51

8.13 Update ............................................................................................................... 51
Chapter 9 Selftest ............................................................................................................... 53
9.1 Valve .................................................................................................................. 54
9.2 Motor .................................................................................................................. 54
Chapter 10 Service ................................................................................................................ 55
10.1 Routine Maintenance ......................................................................................... 55
10.1.1 Clean the Appearance ............................................................................... 55
10.1.2 Replace Fuse............................................................................................. 55
10.2 Daily Maintenance ............................................................................................. 55
10.3 Weekly Maintenance.......................................................................................... 56
10.4 Monthly Maintenance ......................................................................................... 56
10.5 Yearly Maintenance ........................................................................................... 56
10.6 Maintenance before transport or for the instrument that will not be used for a long
time .................................................................................................................... 56
Chapter 11 Troubleshooting .............................................................................................. 58
11.1 Abnormal Startup ............................................................................................... 58
11.2 Waste Full .......................................................................................................... 58
11.3 Diluent Empty..................................................................................................... 58
11.4 Lyse Empty ........................................................................................................ 58
11.5 WBC Clog or RBC Clog ..................................................................................... 58
11.6 WBC Bubbles or RBC Bubbles.......................................................................... 58
11.7 HGB Error .......................................................................................................... 59
11.8 HGB Bubbles ..................................................................................................... 59
11.9 Recorder out of paper ........................................................................................ 59
11.10 Recorder too hot ................................................................................................ 59
11.11 The result of background test too high .............................................................. 60
Chapter 12 Appendix 1 Symbol ...................................................................................... 61
Chapter 13 Appendix 2 Specification................................................................................ 62
13.1 Reagent ............................................................................................................. 62
13.2 Parameter Information ....................................................................................... 62
13.3 Sampling characteristics .................................................................................... 62
13.4 Performance index ............................................................................................. 63
13.5 Background Range ............................................................................................ 63
13.6 Linear Range ..................................................................................................... 63
13.7 ReagentRepeatability index ............................................................................... 63
13.8 Pollution rate ...................................................................................................... 64
13.9 Input/Output ....................................................................................................... 64
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How to use the manual

You are welcome to read this manual. This manual includes the in-depth information
about installation, daily operation, calibration, quality control and maintenance. To achieve the
optimal performance, be sure to operate and maintain the instrument according to this manual.
If you have chosen the optional accessories such as printer, Bar Code Scanner, read the
related manuals of those.
The data in this manual has been calibrated and is efficient. If the instrument is used in
special purpose, or the operational procedures/methods exceed the regulation of this manual,
please contact with the manufacturer to inquire its validity and applicability. Otherwise the
manufacturer will not be able to ensure the accuracy and validity of the measuring results, and
will not perform any obligation for the direct or indirect results resulting from this action.
Avoidance from potential hazard

User should read the Safety Notice and Operation Notice carefully.
There are several safety warning signs in this manual to help operators avoid hurting
themselves or making the instrument damaged, resulting in incorrect measuring results:
. Warning: The instrument must be operated as the operating procedures, or else, there will
be great hazards to both operator and environment.
Caution: Emphasize the operating methods that must be obeyed. Avoid potential hazard
or making the instrument damaged, resulting in incorrect measuring results.
Notice: To emphasize important information.
All personnel that may operate, maintain, remove, service the instrument should read this
manual carefully.
Safety notice
To operate the Instrument safely and effectively, be sure to read the following notices first.
Operating the instrument, without following the appointed methods by the manufacturer, may
break down the defensive function of the system, and cause bodily injury or damage the
instrument.
 Avoid electric shock
1) When the power-on, the unauthorized maintenance personnel should not pen the
instrument.
2) If liquid enters into the instrument or the instrument leakage, please shut off the power
immediately, and contact with our company’s Customer Service Department or local
distributor in due course. Improper use of the liquid may cause electric shock and result
in damaging the instrument.
 Defense for biohazard and chemical hazards
Improper use of the sample may result in being infected.
Avoid hand touch the sample, reagent and waste directly. When operate the instrument, be
sure to wear gloves to avoid being infected.
If the skin touched the sample, manage it according to operator working standard or
inquiring a doctor to take remedial measures immediately.
Use the reagent carefully to avoid hand and clothes touch directly.
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Once hand or clothes touch, flush the touched area with soap and plenty of water
immediately.
If the reagent enters into the eyes incautiously, flush with plenty of water at once, and
inquire a doctor for further treatment.
Be sure not to use flammable dangerous materials around the instrument.
Reagents, quality control serum, some materials in the sample are controlled by Pollution
Regulations and Standard for Discharge of Pollutants. Please abide by the local discharge
regulation and inquire related reagent manufacturer.
 Prevention of fire and explosion
Operation notice
To operate the instrument safely and reliably, be sure to obey the following notices.
• Purpose
Pay attention to the application range of the instrument statement. Make sure your use
does not exceed the application range.
• Limitation of operating environment
The instrument should be installed according to the required installation environment of
the manual. Installation and use out of the appointed range may cause unreliable results, and
make the instrument damaged. Contact with our company’s Customer Service Department or
local distributor if you need to change the state of the instrument.
• Limit of Operator
Only trained and authorized personnel by the manufacturer can operate the
Instrument.
• Maintenance and Service
Be sure to service and maintain the instrument according to this manual strictly.
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Chapter 1 Instrument Introduction

1.1 Name
The full name of the instrument is auto hematology analyzer.
Protection Grade: IP20.
1.2 Structure
Host and accessory.
1.2.1 Host
Control the process of sample collection, dilution and analysis, including the following units:
1. Power Supply unit.
2. Central control circuit unit.
3. Dilute unit.
4. Display unit.
5. Thermal recorder.
1.2.2 Accessory
Including the following accessories:
1. USB mouse.
2. Printer (Optional)
3. Power cord.
4. Ground wire.
1.3 Purpose
It is used for detecting the parameters of RBC, WBC, HGB and differential counter.
The analyzer is used for the determination of the following 20 parameters and 3 histograms blood .
Specimens in Table 1-1

Item Abbreviation Unit
White Blood Cell or leukocyte WBC 109/uL
Lymphocyte percetage LYM% %
Mid-sized cell percetage MID% %
Neutrophil percetage GRAN% %
Lymphocyte LYM# 109/uL
Mid-sized cell MID# 109/uL
Neutrophil GRAN# 109/uL
Red Blood Cell or erythocyte RBC 1012/uL
Hemoglobin Concentration HGB g/dL
Hematocrit HCT %
Mean Corpuscular(erythrocyte) Volume MCV fL
Mean Cell Hemoglobin MCH pg
Mean Cell Hemoglobin Concentration MCHC g/L
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Red Blood Cell Cell (erythrocyte) Distribution Width Coefficient of
RDW-CV %
Variation
Red Blood Cell Distribution Width-Standard Deviation RDW-SD fL
Platelet PLT 109/uL
Mean Platelet Volume MPV fL
Platelet Distribution Width PDW %
Plateletcrit PCT %
Plateletcrit-large Cell Ratio P-LCR %
White Blood Cell Histogram WBC Histogram
Red Blood Cell Histogram RBC Histogram
Platelet Histogram PLT Histogram
Table1-1
1.4 Specifications
• Standard Classification of the Instrument

According to anti-electrical shock hazard: Grade II, Pollution 2
According to the defence for deleterious liquid: General Device(Closing device of non-defensive
liquid)
According to the recommended disinfection/sterilization method of the manufactory: Disinfectant
device recommended by manufactory.
According to safety degree in condition that using gas mixture of flammable anesthetic gas and air
or gas mixture of oxygen and nitrous oxide: Do not use the equipment in condition that using gas
mixture of flammable anesthetic gas and air or gas mixture of oxygen and nitrous oxide.
According to working status: Continuous Running Equipment.
• Principles of Measurement
Blood Cells are counted and sized by Electrical Impedance Method. Hemoglobin is
determined by Colorimetric Method.
• Parameters of Measurement
Basic parameters:
White Blood Cell or leukocyte WBC 109/uL
Red Blood Cell or erythocyte RBC 1012/uL
Hemoglobin Concentration HGB g/dL
Platelet PLT 109/uL
Derived from Histogram:

Lymphocyte percetage LYM% %
Mid-sized cell percetage MID% %
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Neutrophil percetage GRAN% %
Mean Corpuscular(erythrocyte) Volume MCV fL
Red Blood Cell Cell (erythrocyte) Distribution Width Coefficient of
RDW-CV %
Variation
Red Blood Cell Distribution Width-Standard Deviation RDW-SD fL
Mean Platelet Volume MPV fL
Platelet Distribution Width PDW %
Plateletcrit-large Cell Ratio P-LCR %
Calculated Parameters:
Lymphocyte LYM# 109/uL
Mid-sized cell MID# 109/uL
Neutrophil GRAN# 109/uL
Hematocrit HCT %
Mean Cell Hemoglobin MCH pg
Mean Cell Hemoglobin Concentration MCHC g/dL
Plateletcrit PCT %
Sampling Features:
Sample Volume:
Whole Blood Blood Mode: 10uL Whole Blood Blood
Peripheral Blood Mode: 10uL Peripheral Blood
Prediluted Mode: 20uL Prediluted Blood
Reagent Volumes Required for Single Sample:

Diluent 25mL
Lyse: 0.35mL
Whole Blood and Peripheral Blood Mode:

WBC / HGB 1:285
RBC / PLT 1:21667
WBC / HGB 1:500
RBC / PLT 1:43333
Cell Counting Aperture Size:

WBC: 100um
RBC/PLT: um
Throughput: Up to 60 samples per hour
Working mode: Double counting pathway +independent HGB detection system
Display
Liquid Crystal Display (LCD), Touch screen, resolution: 800*600
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Language
English Chinese Spanish
Indicator
20 Parameters and 3 Histograms Display
Alarm Indicator
Working Status (including Power) Indicator Light
Alarm
Interface
One power input socket
One RS232/C serial ports
One VGA interfaces
Two USB interfaces
Recorder
Rapid Thermal Recorder:
Recording width: 35mm
Paper width: 80mm
Precision Specifications of the instrument

Parameter Repeatability
WBC ≤ 5  109 / L
RBC ≤ 5 1012/ L
HGB ≤ 4g / L
HCT ≤5%
PLT ≤8 109/ L
Linear Range
Measurement of the linear
Parameter Measuring range
tolerance
9
0～5.9×10 /L (±0.3×109)/L
WBC
6.0～99.9×109/L ±5%
12
0～0.99×10 /L (±0.05×1012)/L
RBC
1.0～9.99×1012/L ±5%
0～99g/L ±2.0 g/L
HGB
100～300g/L ±2%
9
0～99×10 /L (±8.0×109)/L
PLT
100～999×109/L ±10%
Screen Display and the Range of Report Output Parameters

Parameter Parameter Range Parameter Parameter Range
3
WBC 0-99.9×10 /uL GRAN# 0-99.9×103/uL
6
RBC 0-99.9×10 /uL HCT 0-100%
HGB 0-30g/dL MCH 0-999.9pg
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3
PLT 0-3000×10 /uL MCHC 0-99.9g/dL
MCV 0-250fL RDW-CV 0-99.9%
LYM% 0-100% RDW-SD 0-99.9fL
MID% 0-100% MPV 0-30.0fL
GRAN% 0-100% PDW 0-30.0%
3
LYM# 0-99.9×10 /uL PCT 0-9.99%
3
MID# 0-99.9×10 /uL P-LCR 0-99.9%
Operating Ambient
Temperature: 18℃~35℃
Humidity: 10%RH ~90%RH
Atmospheric Pressure: 70.0kPa ~106.0kPa
Ambient Storage
Temperature: -10℃~40℃
This instrument should be placed at a good ventilation area.
Electric Specifications
Power Supply: 100～240Vac,50/60Hz
Fuse: F3AL250V
Dimensions and Weight

Dimensions: 410mm×435mm×472mm
Weight: 25kg
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1.5 Structure
1.5.1 Front Panel
Figure 1-1
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1.5.2 Rear panel
Figure 1-2
1.6 Operation
Designed according to human engineering and transferring information to users by software
windows and mouse, both are convenient for your operating.
The display screen is shown as the figure 1-3.
Figure 1-3
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 Menu Section
You can operate the instrument by buttons.
The button functions are as follows:

Count: Enter the blood cell analyzer window.
Review: Enter the review menu.
QC: Enter the quality control window to carry out quality control operation.
Calibration: Enter the calibration window to calibrate the instrument.
Maintain: Enter the maintain menu. The maintain window is shown as the figure 1-4.
Figure 1-4
The button in maintain window are as follows:

1) Flush: To get rid of the aperture clog.
2) Enhanced Flush: To get rid of hard aperture clog.
3) Cleaning: Run the normal rinse process to rinse the measurement unit.
4) Prime Chamber: Inject the solutions into the chambers
5) Drain Chambers: Empty the liquid of the counter pool.
6) Drain All: Run the Park Program to rinse and empty the tubing.
7) Prime Diluent: Inject the diluent into the appointed tubing.
8) Prime Lyse: Inject the lyse to the appointed tubing.
9) Prime: Inhale the solutions.
10) Init: Initialize the motors and valves.
11) Shutdown: Startup the shutdown program to rinse the measurement unit
automatically.
12) Screen: Calibrate the screen.
13) Update: Update the software with a USB disk.
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Selftest: User can complete the detection of the valves, motors and other circuit. Selftest window
is shown as figure 1-5.
Figure 1-5
Setup: Enter the main setup window. The main setup window is shown as figure 1-6.
Figure 1-6
1) Print: Enter the printout window to set the functions such as print or report.
2) Date time: Enter the time setting window to set the time of the instrument.
3) Cal factor: Calibration parameters.
4) Auto maintain: Set auto sleep and auto clean.
5) Doctor: Set and edit doctor information.
6) Department: Set and edit department information.
7) Operator: Set and edit users.
8) Ref range: Set and edit ref range.
9) Para unit: Select unit.
10) Gain: Set amplification circuit gain for WBC,RBC and HGB.HGB gain can be set
automatically.
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Log Off: Log off recent user. The log off window is shown as figure 1-7.
Figure 1-7
Next Sample: Setup the information for next count, sample information, patient information,
operator information including.
1) Sample Information: Set sample ID and sample mode.
2) Patient Information: Set patient ID, name, gender and age.
3) Operator Information: Set department and sender.
4) Comment
Add Diluent: Add 1mL diluent for prediluted mode.

Print: Print the counting result.
 Patient and Other information

Display the patient and other information of recent count. We can press Next Sample to set
information for next sample.
 Counting Results
Display the counting results of all items.
Red characters Result above the upper limit
Blue characters Result below the lower limit
Black characters Result within the ref range.
 Histogram
Histograms for WBC,RBC and PLT.
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1.7 Detection Principle
1.7.1 Detection Principles of WBC, RBC, PLT

The count principle of the instrument is based on the measurement of changes in electrical
resistance produced by a particle passing through an aperture sensor.
a) The sample blood is diluted in a conductive liquid. As blood cells are non-conductive, the diluent
is a good conductor. There are big differences between them.
b) When the diluent passes through the aperture sensor, electrodes are submerged in the liquid on
each side of the aperture to create continuous current.
c) When cells pass through the aperture, the resistance between the electrodes increases as the
cell volume increasing, as shown in figure 1-8.According to the Ohm Formulary: U=RI (U=Voltage
I=Current R=Resistance). If I is a constant, U increases as the cell volume increasing.
d) Passing through the magnification circuit, the voltage signal will be magnified and the noise will
be filtered, then you will gain the analytical results, as shown in figure 1-8.
e) One count bath and the detection circuit count the WBC. Another count bath and the detection
circuit count the RBC and PLT. The microprocessor of the instrument calculates and analyzes the cells
(WBC, RBC, PLT), and then gives out the histograms.
f) PLT count adopts advanced liquid, electronics and software system. It settles the repetitive count
of the cells on the side of the aperture count area.
Figure 1-8
1.7.2 Principles of HGB Measurement

Adding lyse in the blood, the red blood cell will rapidly be broken down and release hemoglobin.
Hemoglobin and lyse form a new mixture, which can absorb the wavelength of 540nm.Measure the
absorbency. Through the comparison of the absorbency between the pure diluent and the sample the
concentration of the sample hemoglobin is calculated.
1.7.3 Volume Distribution of Blood Cell

When different types of cells pass through the aperture sensor, there will be different electrical
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pulse height. Because of the evident difference of the cells sizes, the instrument is able to differentiate
the white blood cell, red blood cell and platelet by its pre-set program.
The volume distributions are as follows:
WBC: 20～1000Fl
RBC : 82～98fL
PLT: 2～35fL
The leucocytes disposed by lyse can be divided into three types, according to their volumes:
lymphocyte (LYM), mid-sized cell (MID), Neutrophil (NEUT（GRAN）).
LYM: 35～90 fL
MID: 90～160fL
NEUT : 160～450fL
1.7.4 Results and Calculation of Parameter Measurement
The parameters of the sample blood test can be described in three ways:
a) Measured directly, such as WBC, RBC, PLT, and HGB.
b) Derived from histograms, such as LYM%, MID%, NEUT%, MCV, RDW-SD, RDW-CV, MPV,
PDW, P-LCR.
c) Calculated, such as LYM#, MID#, NEUT#, HCT, MCH, MCHC, PCT.
The derivation of the formularies as follows:
MCV derives from histograms and the instrument collecting and classifying the
erythrocytes according to its volume. It is determined by measuring the average volume of individual
erythrocytes, and the unit is fL.
RDW represents the volume distribution of the erythrocyte populations, derived from the RBC
histogram. It can be expressed by the coefficient variation of the erythrocyte
volume as RDW-CV, and the unit is %.It can also be expressed in standard deviation of
the erythrocyte volume as RDW-SD, the unit is fL.
MPV is the average volume of individual platelets, derived from the PLT histogram. It
represents the mean volume of the PLT populations and can be expressed in fL.
PDW derives from the PLT histogram. It represents the geometry standard deviation (10 GSD) of
the volume of the PLT populations.
P-LCR derives from the PLT histogram. It represents the ratio of the larger PLT and the unit is %.
• HCT (%) = RBC*MCV/100
• MCH (pg) = 10 × HGB/RBC
• MCHC (g/L) = 100 ×HGB/HCT
• PCT (%) = PLT ×MPV/100
• LYM%=100×AL/(AL+AM+AG)
• MID%=100×AM/(AL+AM+AG)
• NEUT%=100×AG/(AL+AM+AG)
• LYM#=LYM%×WBC/100
• MID=MID%×WBC/100
• NEUT#=NEUT%×WBC/100
AL: Number of cells in LYM area;
AM: Number of cells between lymphocyte and Neutrophil area;
AG: Number of cells in NEUT area.
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Chapter 2 Installation
2.1 Package
If packing damage is discovered after receiving the instrument, or the instrument is badly
damaged, contact with the freight agent immediately to file a claim according to the damage
level. At the same time contact with your supplier to make sure the packing is complete. Then
unpacking and installing the instrument as the following steps.
2.2 Unpack
Take out the instrument and accessories from the packing case carefully. Preserve the
packing material for future transportation or storage.
1. Check the accessories according to the packing list.
2. Check whether there are mechanical damages on the instrument and accessories
IF there is any problem, please recover the package and contact with your supplier
immediately.
2.3 Installation Requirements

2.3.1 Installation Environment
The instrument should be placed on a clean steady platform. Keep away from direct
sunlight and dust.
Temperature: 18~35°C
Humidity :≦70%
Atmospheric pressure : 70.0~106.0Kpa.
Caution:
The instrument should avoid direct sunlight.
Caution:
The working environment of the instrument should avoid powerful equipment such as
Centrifuge, CT machine, NMR equipment, X-ray machine etc
Caution:
Do not use equipment that may create strong radiation field such as mobile phone and
cordless telephone. Strong radiation field will disturb some functions of the instrument.
2.3.2 Space Requirement

At least 20cm on each side is the preferred access to ensure good airiness
Notice:
Reagents must be placed at the same working height as the instrument.
2.3.3 Power Requirement

The power requirement as follows:
• AC 100～240Vac, 50 Hz/60 Hz
• The maximum power consumption is 200VA
Warning:
The instrument requires a single well-grounded power socket. Its grounding voltage is no
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more than 0.5V

Warning:
A grounded outlet is required to connect with the grounding pole on the rear panel. Make
sure of the reliability of the power grounding at working site.
Caution:
Fluctuating electric will badly decrease the performance and reliability of the instrument.
Proper action such as the installation of UPS (self-preparation) should be taken before use.
2.4 Reagent tubing connection

There are three tube connectors with color of white, green, red on the rear panel of the
instrument.
2.4.1 Lyse Connection

Take out the lyse tube with red connector from the accessory kit.
Connect the red lyse tubing connector with the tubing connector of the same color on the rear
panel of the instrument.
Place the other end of the lyse inlet tubing into lyse container, and turn the container cover
until secure.
2.4.2 Diluent Connection

Take out the diluent tube with green connector from the accessory kit.
Connect the green diluent tubing connector with the tubing connector of the same color on the
rear panel of the instrument.
Place the other end of the diluent inlet tubing into diluent container, and turn the container
cover until secure.
2.4.3 Waste Connection

Take out the waste tube with white connector from the accessory kit.
Connect the white waste tubing connector with the tubing connector of the same color.
Connect BNC plug with BNC socket marked "WASTE" on the rear panel of the instrument
Turn the waste container cover clockwise until secure.
Caution:
After completing all the tubing installation, keep the tubing natural state, without distortion,
folding, and twist.
Caution:
All the tubing connectors must be installed manually. Forbid using any tool.
Caution:
The reagent must be applied with the instrument. Otherwise it may easily cause inaccurate
measurement results and incorrect classification of the blood cell, or make the tubing system
badly damaged.
Caution:
Keep the reagent from direct sunlight.
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Caution:
After replacing the reagent container, discard the rest of the reagent in the former container.
Forbid putting the rest of the reagent into the replacing container. Avoid polluting the new
replacing reagent.
Caution:
When replacing the reagent, avoid making the plastic tube (inserted into the reagent
container) contact other things. Avoid polluting the new replacing reagent.
Caution:
Avoid using frozen reagent.
Caution:
Avoid using the reagent out of its expiration date.
Warning:
Handle and dispose of the waste according to acceptable laboratory, local state and
national standards.
2.5 Recorder Paper Installation

a) Tear down the gummed paper from the door of the recorder.
b) Gently press the door of the recorder to open it.
c) Insert the new paper into the paper entry, and make the printing side towards the thermal
head.
d) When the paper juts out from the other side, pull it out and keep it straight.
e) Pull the paper out of the paper exit.
2.6 Printer Installation (Optional)

Take out the printer from the packing case carefully. Install the printer according to the
printer manual.
NOTICE: The printer cable can only be connected with the interface marked on
the rear panel of the instrument.
2.7 Power Cable Connection

Make sure the power switch is off (0) on the rear panel of the instrument. Insert one end of
the power cable into the power cable interface on the instrument, the other end into the power
socket.
Connect the ground wire to the grounding port on the instrument.
Warning:
Ensure the power is suitable for the instrument before connection.
- 21 -
Chapter 3 Sample Analysis

3.1 Preparation Before Startup
Every time before startup, the operator should do the following checks:
a) Whether the diluent，lyse and waste tubing are distortion, folding, twist, and whether
the connection is secure.
b) Whether the power cable connection is secure.
c) Whether the ground connection is secure.
d) Whether the accessory connection is secure.
3.2 Startup
If external printer is equipped, turn on the printer power and ensure they are in ready
status.
Press the power button on the rear panel of the instrument, then the power lamp on the
front panel of the instrument lights on. The instrument automatically performs initialization
program.
After completing initialization, the instrument will access self-test window. It tests the
working conditions of each part and if there is enough diluent, and lyse. Simultaneously prime
and clean the tubing.
After self-test, the instrument will access blood cell analyzer window, as shown in Figure
3-1. If the system detects malfunction, the failure information will be displayed on error
Information bar.
Figure3-1
- 22 -
The button functions in blood cell analyzer window are as follows:

Next Sample: Enter the information window of the next sample, input and modify the
information.
Add Diluent: To get 1mL diluent every time from the needle.
Print: Output the data of the current sample to the appointed device.
Jump to the first result. Jump to the last result.
Jump to the previous result. Jump to the next result.
3.2.1 Sample Mode
In the blood cell analyzer window, press the position marked in red box shown in figure
3-2 to enter the sample mode window (figure 3-3).
Figure 3-2
Figure 3-3 sample mode window
- 23 -
We can also set sample mode in “Next Sample” window. “Next Sample” window is shown
in figure 3-4.
Figure 3-4
Mode: Choose the sample mode among Whole Blood Blood Mode, Peripheral Blood Mode
and Prediluted Mode.
Add Diluent: Inject the diluent quantificationally (1 mL)by sample needle. This menu uses
only in Prediluted Mode.
3.3 Background Test

Background test is recommended after the instrument startup normally every time. The
operator can also perform background test in need. The operating procedures as follows:
Press the "START" key below the sample needle directly for background count.
The permissive range of the background test results are shown as table 3-1.
Parameters Data
WBC ≤ 0.3  109 / L
RBC ≤ 0.03 1012/ L
HGB ≤1g/L
HCT ≤ 0.5 %
PLT ≤ 5 109/ L
Table 3-1
If the value of the background test exceeds the permissive range, repeat the upper testing
procedures until the testing result is acceptable. If the test has been carried on above five
times, the testing result still cannot reach the standard required.
- 24 -
Notice:
Only five parameters WBC, RBC, HGB, HCT, PLT can be tested and displayed in
background test.
3.4 Quality Control

It is necessary to perform quality control in installation for the first time or before sample
analysis every day. Further information and procedures are specified in Chapter 4 "Quality
Control".
3.5 Preparation for sample collection

The sample can be collected either from Peripheralblood or from Whole Blood blood.
3.5.1 Whole Blood Blood Collection

It is possible to collect Whole Blood blood by using negative pressure tube or in common
collecting method.
Add some anticoagulant in advance to the container for Whole Blood blood collection.
EDTA.K2.2H2O is commonly used as the anticoagulant, whose specified content is 1.5～
2.2mg/ml blood.
3.5.2 Peripheral Blood Collection

Parts for blood collection:
Adult: Middle finger tip inner of the left hand, or ring finger
Child (above six-month-old): tip inner of the left hand
Infant (under six-month-old): Middle finger Outer side of the thumb or foot
1. Gently massage the blood collection part to make it congest naturally, wipe the
partial skin with tampon containing 75% alcohol, then air.
2. Pinch the puncturing part, and puncture it with aseptic sample needle quickly. The
puncturing depth is about 2-3mm.
3. Wipe off the first drop of blood, and then start collection.
4. Press the wound with tampon for a moment after finishing the collection.
Notice:
The Peripheral blood collection should follow the professional Peripheral blood collection
standard. The general method is partial centesis. The typical collection is puncturing from the
tip of the finger.
Caution:
If the blood flows not freely, press far away from the wound, not around the wound. Avoid
the make the histiocyte mixing into the blood, resulting in incorrect analytical result.
3.5.3 Prepare Samples in Prediluted Mode
a) In the blood cell analyzer window, Press “Add Diluent” button to enter add diluent
window. The window is shown in figure 3-5.
- 25 -
Figure 3-5
b) When the "Diluent" pops up, place a clean sample cup obliquely under the probe.
Press "START" key. The instrument starts to add diluent quantificationally. When
adding the diluent, the sample cup must be placed obliquely under the sample
needle, which allows the diluent to run down the cup wall without forming air
bubbles.Scrape the drops at the top of the sample needle into the sample
cup ,collect 20uL peripheral sample in pipette. Wipe the blood attached on the outer
layer of the pipette with clean tissues. Immediately mix up the sample in the diluent
sample cup.
c) Press cancel to go back to the blood cell analyzer window. Then select sample mode
to prediluted.
Notice:
If there is a need to prepare samples in quantities in prediluted mode, user can use the
"Add Diluent" function to continuously prepare the diluent.
3.5.4 Prepare Samples in Peripheral Mode

Collect 40-L Peripheralsample in pipettes. Immediately mix up the sample in anticoagulated
warhead sample cup. You can also add the Peripheralblood to the anticoagulated warhead
sample cup directly.
3.5.5 Sample Homogenization

The blood samples must be fully homogenized before use. The recommended method is:
Shake up the tube up and down 3-5 minutes, blood mixer is recommended to make the
- 26 -
sample be fully homogenized and ensure the accuracy of measurement.

Caution:
If the sample has been placed for a long time or mixed inadequately, it will easily cause
measurement error and incorrect testing results.
Caution:
Avoid shaking up the pipette violently
Caution:
The sample to be tested can only be stored at room temperature, and the test must be
finished within 4 hours.
3.6 Sample count and Analysis

After finishing sample collection, perform count and analysis procedure as follows.
3.6.1 Input Sample Information

In the blood cell analyzer window, click "Next Sample" button, pops up information edit
window. Move the cursor to the required inputting item textbox. Input or select the data, and
press "OK". The instrument will save the input information and returns to blood cell analyzer
window. Pressing "Cancel" key, the instrument cancels the input information and returns to
blood cell analyzer window.
Sample ID: The ID can increase by one automatically after a testing.
Mode: Set the sample mode.
Patient ID: Input patient ID.
Name: Input patient’s name.
Gender(Sex): Select male or female, and the default is male.
Age: Input age of patient. And choose the unit from year, month and day.
Department: Select department. Users can setup and edit department information in “Setup”
window.
Sender: Select sender (doctor). User can setup and edit doctor information in “Setup” window.
Comment: The operator can write the comment in the blank.
Notice: Users can edit all the sample information except sample mode in “Review” window.
3.6.2 Procedures of Sample Count and Analysis

a) Place a sample cup under the sample needle, press "START" key. The instrument
starts to aspirate the liquid. Move the sample cup after the needle needle begins to move
upward.
b) The instrument starts to analysis the sample automatically. Please wait for the
analytical result. The process takes about 1 minute.
c) After the analysis finished, the result will be displayed in the rear of the corresponding
parameters on blood cell analyzer window of the instrument, with histograms WBC, RBC, and
PLT. As shown in figure 3-1.
If "Auto Print " item is selected , the recorder or printer will output the test results automatically.
If there are clogs or bubbles during the count and analysis process, the information section
- 27 -
would display "Clog" or "Bubble".
3.6.3 Parameter Alarm
"L": To indicate the data has exceeded the setup lower alarm limit of the parameter.
"H": To indicate the data has exceeded the setup higher alarm limit of the parameter.
"***": To indicate that the data is invalid.
Notice:
When PM alarm occurs on PLT histogram, the result of parameter PDW is "***".
Notice:
If the result of WBC is less than 0.5×10 /L, the system will not perform leukocyte
differential. The display for all parameters related to leukocyte differential is "***".
3.7 Shutdown
Shutdown routine must be performed before turning off the power everyday.
During shutdown procedure, the instrument will perform daily maintenance and clean the
tubing automatically.
The procedures are:

a) In "Maintain" window, press "Shutdown" button.
b) The instrument will perform daily maintenance and clean the measuring tubing.
When the shutdown procedure finished, the screen displays "Shutdown finish，
please power off the machine", turn off the power on the rear panel of the
instrument.
c) Turn off the printer power (if equipped), clean the workbench and dispose the waste.
Notice:
Do not turn off the power of instrument directly while performing the shutdown procedure.
- 28 -
Chapter 4 Quality Control

Quality Control means the precision, accuracy and repeatability of the system. Quality
control provides reliable and effective methods for the possible system errors in detection and
prevention. The system errors may cause unreliable analytical result of the sample. To
maintain the reliability of the analytical results, periodic quality control of the instrument is
required.
The instrument provides 9 QCfiles for user. It allows the operator run quality control to the
12 parameters at the same time.
Caution:
Controls must be stored in appropriate conditions.
Caution:
Don not use controls deteriorated blood or out of its expiration date.
Caution:
Be sure to finish the quality control in a certain time every day.
4.1 Edit Quality Control Files

The main QC window is shown in figure 4-1.
Figure 4-1
In the main QC window, select a QC file, press “Setup” in figure 4-1to enter QC setup
window, in this window, user can input Lot No and Exp. Date of the control, the assay and limit
of the quality control parameters. In the QC setup window, user can edit a existing QC file.
Press “Save” button to save the data of the current QC file, and press “Return” button to return
to the main QC window.
- 29 -
The QC setup window is shown in figure 4-2.
Figure 4-2
Notice:
If the parameter is an invalid data, the system will take the assay and limit as no
assignment.
It needs to re-input. Or else the quality control will only act on other parameters.
Notice:
If the lot number or expiration date is invalid, the system will take them as no assignment. It
needs to re-input. Or else the QC file can not run quality control program.
4.2 Quality Control Run

In the main QC window, select a QC file, then press “List” to enter QC test window.
Prepare the controls and shake up the container until it well-mixed. Place the controls under
the sample needle，press "START" key to begin the QC testing. When the measurement
finished, the result will be displayed on the column of the current window. User can also select
and delete one or some of the results in the QC test window.
The QC test window is shown in figure 4-3.
- 30 -
Figure 4-3
Press "Return" button, the instrument will return to main QC window.
Notice:
Each QC file can store up to 30 QC data.
4.3 Quality Control Graph

In the main QC window, select a QC file, press “Graph” to enter the QC graph window. The
graph provides a visual observation of the control data, allowing the operator to observe the
possible deviations, trends or shifts of the instrument performance.
The QC graph window, is shown as figure 4-4.
Figure 4-4
- 31 -
The screen can display 2 QC items at the same time. The figure shows the file NO., Lot
NO., Exp.date number and distribution of the QC data. Click the button to scroll the
screen to the right or press to scroll the screen to the left.
- 32 -
Chapter 5 Calibration
The instrument has been calibrated strictly at the factory. You may need to perform
calibration procedures when you replace any component that involves the primary
measurement characteristics, or when the shift occurs during controls. Calibration of the
instrument is to provide the assurance that the instrument is providing results with accuracy as
design. The purpose of calibration is to ensure the accuracy of the measurement result meet
the requirement of the design all the time.
To ensure the accuracy of the instrument and obtain reliable measurement results, it is
necessary to calibrate the instrument in the following situations:
a) Installation for the first time or re-setup in a new place.
b) The instrument is maintained.
c) The result of quality control is abnormal.
d) Replace reagent.
To ensure the instrument's precision and obtain reliable measured results, the instrument
should be calibrated in these situations:
Warning:
Calibrators should be stored and used properly according to the calibrator manual.
Warning:
Make sure the instrument is in a normal state before calibration.
Warning:
Avoid using the result of the measurement on medical test or clinical before the calibration
is finished accurately.
Check the instrument and reagents carefully before calibration. Make sure the instrument in
normal status, and make sure the required sample mode of the measurement.
5.1 Operator calibration
5.1.1 Background Test
Refer to Chapter 3 "Sample Analysis" / Section 3.3, Ensure that the background test
meets the requirement and no malfunction occurs.
5.1.2 Assurance of Repeatability

To ensure the calibration accurate, it is necessary to evaluate the repeatability
measurement of the instrument. Make sure the instrument is in normal status, then perform
calibration program.
The procedures are as follows:
a) In the blood cell analyzer window, Measure repeatedly with the calibration (no less
than 3 times).
b) Record the data of WBC, RBC, HGB, MCV, PLT. Calculate the CV value according to
the following formula. Only the result is in the limit of table 5-1 can perform calibration.
- 33 -
5.1.3 Calculate Calibration Factors
Calculate the new calibration factors according to the following formula:
5.1.4 Modify the Calibration Coefficient
a) In the main setup window , press“Cal factor”button to enter operator calibration

window. The operator calibration window is shown in figure 5-1.
Figure 5-1
- 34 -
b) Input the calibration data to the data blank.

c) Press "Print" button. The instrument will print the current calibration result.
d) Press "OK" button to save the current calibration result and return to the main Setup
window.
e) Press "Cancel" button. The instrument will cancel the current calibration result and
return to the main Setup window.
5.2 Auto Calibration

The main Calibration window is shown as figure 5-2.
Figure 5-2
The calibration procedures are as follows:
a) Enter the main Calibration window, press “Setup” button to enter calibration setup
window, the window is shown in figure 5-3.
- 35 -
Figure 5-3
b) Input the reference value of each calibration parameter, press “OK” to save and enter
the calibration test window. The window is shown as figure 5-4.
Figure 5-4
c) Prepare the calibrators and shake up the container until it well-mixed.
- 36 -
d) Place the calibrators under the sample needle. Press "START" key to do calibration test.
e) When the measurement finished, the result will be displayed on the column of the
current window. If alarm occurs in measurement, the current result may be incorrect.
f) Press "Del" button to delete the result or press "Clear" to delete all the results and test
again after the problem is solved.
g) Press "Save" button to save the calibration result
Notice:
Calibration can be performed 5 times at the most.
Notice:
The calibration result will be displayed after testing 3 times.
Notice:
If the parameter is an invalid data, the system will not perform calibration. It needs to
re-input valid data.
- 37 -
Chapter 6 Setup
The instrument has accomplished all the settings at the factory. For customer's
convenience, most of the system parameters can be setup by the operator so as to meet
various requirements.
Notice:
The operations in this chapter will change the running state of the instrument. Please make
sure the necessity of the changing before operating.
6.1 Print
In the main setup window, press “Print” button, the instrument will enter the print setting
window. As shown in figure6-1:
Figure6-1
Click the menu box you want to adjust, pops up the optional window .Click the item you
want to set.
Press "OK", the instrument will save the current parameters and return to the main setup
window. Press "Cancel" button, the system will not save the current parameters and return to
the main setup window.
 Printer select
Select Recorder, the data will only be transmitted to the recorder（built in thermal printer）.
- 38 -
Select USB printer, the data will only be transmitted to USB interface.
Notice:
If the USB printer is selected, the system will automatically detects the type of printer.
 Report setting
Set the printing effect for built in thermal printer and external USB printer.
Set or edit the report title.
 Auto print
If this option is selected，the select printer will print automatically after a sample
measurements.
 Print graph
If this option is selected，the report will be printed with histogram.
6.2 Date Time

In the main setup window, press “Date time” button, the instrument enters the date and
time setting window. As shown in figure 6-2. Click the menu bar to adjust setting item. Press
"OK". The instrument will save the current parameters and return to the blood cell window.
Press "Cancel" button, the system will not save the current parameters and return to the main
setup window.
Figure 6-2
6.3 Cal factor

About cal factor, please read 5.1.3.
- 39 -
6.4 Auto maintain

In the main setup window, press “Auto maintain” button, the instrument enters the auto
maintain window. As shown in figure 6-3.
Figure 6-3
In this window, user can set running time for the auto sleep and auto probe clean. When
"OFF" is selected, the auto sleep and auto clean will not work.
Press "OK", the instrument will save the current parameters and return to the main setup
window. Press "Cancel" button, the system will not save the current parameters and return to
the main setup window.
Sleep function can greatly save electrical energy and extend the life of the instrument.
During sleep time, the instrument will turn off part of the circuit power, and take the sample
needle back. Press the left key of the mouse or any key on the keyboard, sleep will be
canceled.
Auto clean can ensure the tubing of the instrument clean and prevent the possible
measurement malfunctions and maintain the instrument.
When the running time of the instrument exceeds the setting time，the instrument will go to
sleep mode or perform "Clean" procedure automatically.
6.5 Doctor setting

The doctor information can help user setup perfect sorting information in advance, and
quicken the input speed and management of the sample information. Especially the
abbreviation greatly improves the communication and standardization construction of
laboratory digital information.
In the main setup window, press “doctor” button, the instrument enters doctor setting
window. As shown in figure 6-4.
User can manage the doctor information in this window.
Click "Add" button to found new doctor. Select an existing doctor and click "Delete" to
delete it. Select an existing doctor and click "Edit" to edit the information.
Click "Cancel" save the setting and return to the main setup window.
- 40 -
Figure 6-4
Figure 6-5
User can manage the department information in this window.
- 41 -
Click "Add" button to found new department. Select an existing department and click
"Delete" to delete it. Select an existing department and click "Edit" to edit the information.
6.6 Operator setting

In the main setup window, press “department” button, the instrument enters department
setting window. As shown in figure 6-6.
Figure 6-6
User can manage the user ID in this window.
Click "Add" button to found new user. Select an existing user and click "Delete" to delete it.
Select an existing user and click "Edit" to edit the information.
6.7 Ref range

In the main setup window, press “Ref range” button, the instrument enters ref range
- 42 -
Figure 6-7
There are 5 groups can be selected, including adult female, adult male, child, common and
infant.
Select a group, click the menu box you want to adjust, then input the value.
Press "Save", the instrument will save the current parameters. Press "OK", the instrument
will save the current parameters and return to the main setup window. Press "Cancel" button,
the system will not save the current parameters and return to the main setup window.
6.8 Para unit

In the main setup window, press “Para unit” button, the instrument enters parameter unit
In this window, user can select units for 20 items.
Press "OK", the instrument will save the current setting and return to the main setup
window. Press "Cancel" button, the system will not save the current setting and return to the
main setup window.
- 43 -
Figure 6-8
6.9 Gain
In the main setup window, press “Gain” button, the instrument enters parameter gain
setting window. As shown in figure 6-9
Figure 6-9
In this window, user can set WBC，RBC and HGB gain.

Press "Auto", the HGB gain can be set automatically.
- 44 -
main setup window.
6.10 Transmit
In the main setup window, press “Transmit” button, the instrument enters transmit setting
window. As shown in figure 6-10.
Figure 6-10
User can select “auto transmit”. If “auto transmit” is selected, the instrument will transmit
the blood cell analyzing result to the 232 port automatically.
main setup window.
- 45 -
Chapter 7 Review
The instrument can automatically store the results after each sample analysis. The
operator can review, search, edit, print, and delete the data. The "Review" window is shown in
figure 7-1.
Figure 7-1
The data can be reviewed and printed in table. 8 sample parameters are displayed in each
review screen in the order of time sequence. Press the buttons at the bottom of the
screen to review the front data. Press the buttons at the bottom of the screen to review
the rear data.

The meaning of the characters as follows:
"H" is displayed following the parameter indicating that the results exceed the high limit of
the system. And the characters are colored red.
"L" is displayed following the parameter indicating that the results exceed the low limit of
the system. And the characters are colored blue.
7.1 Sample search

In the "Review" window, press "Search" to enter the sample search window. The window
is shown in figure 7-2.
In the sample search window, press "All" to show all the sample results. Input one or more
conditions, and press "Search" to begin the search. Press "Cancel" button to cancel the
- 46 -
searching and return to the main review window.
Figure 7-2
Figure 7-3
- 47 -
7.2 Sample edit

In the "Review" window, press "Edit" to enter the sample edit window. The window is
shown in figure 7-3.
In the sample edit window, user can edit all the information of the sample except blood
mode. Press "OK" to save the edit. Press "Cancel" button to cancel the editing and return to
the main review window.
7.3 Sample delete

In the "Review" window, select one or more samples, press "Delete" to enter the sample
delete window. The window is shown in figure 7-4.
Figure 7-4
If users select “All items” and press OK, all results will be deleted; If users select “Selected
Items” and press OK, the selected results will be deleted; If press “Cancel”, no result will be
deleted and the system will return to the main review window.
7.4 Sample export

In the "Review" window, press "Export" to export the select results to a USB disk.
The procedures as follows:
a) Connect a USB disk to the equipment.
b) Select one or more sample results and click "Export" button. The system will enter to
the export window. The window is shown as Figure 7-5.
- 48 -
Figure 7-5
If users select “All Items” and press “OK”, all the results will be exported to the USB
disk; If users select “Selected Items” and press “OK”, the selected results will be exported
to the USB disk; If press “Cancel”, no result will be exported and the system will return to the
main review window.
User can find a file，which is named similar to “review_20000101_024022.csv”after the
export is complete.
7.5 Sample print

In the "Review" window, press "Print" to print the selected samples.
7.6 Sample transmit

In the "Review" window, press "Transmit" to transmit the selected samples to the 232 port.
The system will display string such as“transmit 3 records of 3”(3 results are selected) on the
screen.
- 49 -
Chapter 8 Maintain
This chapter gives the description of various service functions provided by the instrument.
These functions will bring user convenient and pleasure. The window is shown in figure 8-1.
Figure 8-1
8.1 Flush
This function is used for solving general probe clogs. The instrument makes a fixed
pressure and voltage act on the probe to get rid of the clogs.
8.2 Enhanced Flush

This function is use to solve indolent probe clogs. Probe cleaner would be injected into
WBC and RBC count pool(chamber). Get rid of the indolent probe clog by soaking it in the
probe cleaner. Before performing the function, user should prepare the probe cleanser well.
8.3 Cleaning
This function is used for the routine cleaning of the probe, sample needle, metering tube
measurement tubing.
8.4 Prime Chambers

This function use to Fill diluent to the chamber.
- 50 -
8.5 Drain Chambers

This function is used for user to observe the count pool. The instrument will empty the liquid
in the count pool.
8.6 Drain All

Manufacturer suggests you do not use this function .If the instrument is not going to be
used in 2 week or longer, use this function to clean and empty the instrument. It is convenient
for user to store the instrument. Prepare distilled water before performing the function.
8.7 Prime Dilutent

Prime diluent to relative tubing.
8.8 Prime Lyse

Prime lyse to relative tubing.
8.9 Prime
Prime both diluent and lyse to relative tubing.
8.10 Init
Initialize the valves and motors.
8.11 Shutdown
Please read 3.7 of this document.
8.12 Screen
Calibrate the screen. Press this button（if the touch screen is not inaccuracy, user can use
a USB mouse to click the button）to enter the screen calibration process. Follow the
instructions on the screen, user can calibrate the screen when the device restarts.
8.13 Update
Update the software with a USB disk. In maintain window, click“update”to enter update
window. The window is shown as figure 8-2.
- 51 -
Figure 8-2
The procedures as follows:
a) Prepare a USB disk, and create a folder named “update” under the U disk root
directory. Copy the update file, which is named similar to
“update_kd3800_v_20190****.tar.gz”to the folder “update”.
b) Connect the USB disk to the equipment.
c) Enter the update window, the system shows “Finding available update files” in the
screen. When the file name similar to “update_kd3800_v_20190****.tar.gz”is
displayed in the blank, select the file and click “Update” to begin the updating. Click
“Cancel” to cancel the updating.
b) The screen display “Uncompressing update file”. Wait until Select one or more
sample results and click "Export" button. The system will enter to
- 52 -
Chapter 9 Selftest
Enter main “Selftest” window. User can complete the detection of the valve, motor, circuit
and interface. It is helpful to the insurance of the malfunction. The main selftest window is
shown as figure 9-1.
Figure 9-1
Figure 9-2
- 53 -
9.1 Valve
In the main selftest window, click “Valve” to enter valve test window. The window is shown
in figure 9-2.
V1 to V12 are the 12 valves on this device, and V13 to V16 are vacant. Click a valve such
as “V1” to test it.
If the valve works, the sound of solenoid valve suction can be heard.
Click “OK” the system will return to the main selftest window and the instrument initialize
automatically.
9.2 Motor
In the main selftest window, click “Motor” to enter motor test window. The window is shown
in figure 9-3.
Figure 9-3
Motor X, Motor Y, Sample Pump and Vacuum Pump are the 4 motors on this device, click a
motor such as “Motor Y” to test it.
Notice:
If the motor works, it will move according to the flow. If not, the system will give a sound
alarm, and there will be error message displayed in red color in the lower right corner of the
screen.
To protect the needle, you can't test motor X directly. You must test motor Y first, the
needle moves to the highest position. If you test motor X directly or Y motor is in trouble, the
needle can not move to the right position, and
Click “OK” the system will return to the main selftest window and the instrument initialize
automatically.
- 54 -
Chapter 10 Service
As other precision instrument, only careful daily service and periodic maintenance can the
instrument have a good working status, and can we get the reliable measurement results and
have few malfunctions.
This chapter introduces some preventive methods for service and maintenance.
If you want to know more relative information, please contact the customer service department
of our company.
According to the requirements for maintenance of the instrument during the using
procedures, we divide the preventive service and maintenance into the following types: daily,
weekly, monthly, yearly and maintenance according to actual need.
Warning:
It is important for the hospital or organization that employs this instrument to carry out a
reasonable maintenance schedule. Neglect of this may result in machine breakdown.
10.1 Routine Maintenance
10.1.1 Clean the Appearance

Wipe the appearance of the instrument with neutral detergent or distilled water.
Caution:
Avoid using corrosive acids, alkali, and volatile organic solvent such as: acetone, aether,
chloroforms to wipe the appearance of instrument. Only neutral detergent can be used.
Caution: Avoid wiping the inner of the instrument.
10.1.2 Replace Fuse

The fuse is installed in the fuse-box on the side of power switch. Open the box to replace
the fuse expediently.
Appointed specification fuse: F3AL250
Warning:
Only appointed specification fuse can be used.
10.2 Daily Maintenance

It can be divided into two types: run and shutdown.
• Run
The instrument has installed daily maintenance procedure, on running ,it can execute auto
cleaning procedure according to the quantity of the sample to keep the instrument in good
working status. Set the auto cleaning procedure according to the section 6.3. The general
setting principles are:
Working time > 8 hours, auto-cleaning time=8 hours;
4 hours<Working time<8 hours, auto-cleaning time=4 hours;
Working time< 4 hours, auto-cleaning time=2 hours;
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The auto-cleaning time will decrease 1 hour year by year.

• Shutdown
When the instrument shutdown, it will run daily shutdown auto cleaning procedure. You
only need to clean the workbench and wipe the appearance of instrument when the power-off.
10.3 Weekly Maintenance

This instrument has installed weekly maintenance procedure. Act as follows:
a) Prepare probe cleanser.
b) In the maintain window, finish all the operations according to the prompts on the
screen.
c) Turn off the power supply.
d) Wipe the appearance of instrument as section 9.1.1.
10.4 Monthly Maintenance

It is necessary to clean the dust of the instrument monthly.
Operate as follows:
a) Turn off the power supply, and pull out the power line.
b) Open the right door and gently brush the dust of the instrument internal
c) After the cleaning, don't use immediately, run the cleaning program to rinse the
measurement unit automatically.
10.5 Yearly Maintenance

It's necessary to perform preventive maintenance once every year. Because of the
highly-requirements for yearly maintenance, the maintenance should be performed by the
authorized engineer of our company. Please contact the customer service department of our
company before yearly maintenance.
10.6 Maintenance before transport or for the instrument that
will not be used for a long time

If the instrument is not going to be used in 2 weeks or longer, or need to pack and transport,
performing the following procedures:
a) In the maintain window, operate as screen shows.
b) Rotate the bottle covers of rest reagents and store them as the reagent operation
introduction. User should perform efficient action to prevent the material from deteriorating,
mis-eating and misusing.
c) Plug the stopples which were pulled out at the first installation into the corresponding
tube connector.
d) Pull out diluent connection tube ,, lyse connection tube and waste connection tube and
clean them with distilled water. Dry them in shady place, then packing them into plastics.
- 56 -
e) Pull out the power wire, packing it in plastics after cleaning with neutral detergent.
f) Put the instrument and parts packed in plastics into packing cases.
- 57 -
Chapter 11 Troubleshooting
This chapter contains information that is helpful in identifying and resolving instrument
problems that may occur in the operation of the analyzer. If the problems can not be corrected
with the aid of this chapter, the user should contact the Customer Service Department of our
company.
11.1 Abnormal Startup

Methods and procedures:
a) Check if the power is on.
b) Check if the power socket is loose.
c) Check if the fuse is broken. If broken, replace it as section 9.1.2.
11.2 Waste Full

Dispose of the waste in waste container.
11.3 Diluent Empty

a) Replace diluent.
b) In the maintain window, click "Prime Diluent".
11.4 Lyse Empty

a) Replace lyse.
b) In the maintain window, click "Prime Lyse".
11.5 WBC Clog or RBC Clog

If the count time exceeds high limit of the setting during measurement, there will "Clog"
alarm occurs.
a) In the maintain window, click "Flush" shortcut key.
b) If the upper method could not solve the problem, perform as the following procedures.
c) In the maintain window, click " Enhanced Flush" in the menu. Follow the screen prompt
information to finish it.
11.6 WBC Bubbles or RBC Bubbles

If the count time exceeds low limit of the setting during measurement, there will be
- 58 -
"Bubble" alarm occurs.

In the maintain window, click " Enhanced Flush" in the menu.
11.7 HGB Error

a) In the maintain window, click “prime”.
b) In the main setup window, click “Gain” to enter gain setup window, click “Auto” to adjust
HGB gain automatically. Then do a blank test.
c) If the upper method could not solve the problem, perform as the following procedures. In
the maintain window, click "Cleaning". Then do a blank test.
d) If the upper method could not solve the problem, perform as the following procedures.
In the maintain window, click "Enhanced flush" in the menu. Then do a blank test.
11.8 HGB Bubbles

a) In the maintain window, click “prime”.
b) In the main setup window, click “Gain” to enter gain setup window, click “Auto” to adjust
HGB gain automatically. Then do a blank test.
c) If the upper method could not solve the problem, perform as the following procedures. In
the maintain window, click "Cleaning". Then do a blank test.
d) If the upper method could not solve the problem, perform as the following procedures.
In the maintain window, click "Enhanced flush" in the menu. Then do a blank test.
11.9 Recorder out of paper

a) Gently press the recorder door to open it.
b) Insert the new paper into the paper entry, and make the printing side towards the thermal
head.
c) When the paper juts out from the other side, pull it out and keep it straight.
d) Pull the paper out of the paper exit.
e) Close the door of the recorder.
11.10 Recorder too hot

Possible reasons:
The thermal head of the recorder is too hot.
Suspend using the recorder for 5 minutes.
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11.11 The result of background test too high

a) In maintain window, click " Cleaning".
b) If the upper method could not solve the problem, repeat the procedure 3 times. If the
problem still can not be solved, perform as the following procedures.
c) In the maintain window, click "Enhanced flush".
d) If the upper method could not solve the problem, repeat the procedure 3 times. If the
problem still can not be solved, perform the upper procedure after replacing all the reagents
- 60 -
Chapter 12 Appendix 1 Symbol
COM Interface
COM Interface
Usb Interface
Equipotentiality
Biohazard
High Temperature
Caution
- 61 -
Chapter 13 Appendix 2 Specification
13.1 Reagent
Diluent, Lyse
13.2 Parameter Information

Item Unit
9
WBC 10 / L
Neu# 109 / L
Lym# 109 / L
Mid# 109 / L
Neu% %
Lym% %
Mid% %
RBC 1012/ L
HGB g/L
HCT %
MCV fL
MCH pg
MCHC g/L
RDW-SD fL
RDW-CV %
PLT 109 / L
MPV fL
PDW None
PCT %
p-LCR %
RBC Histogram None
PLT Histogram None
WBC Histogram None
13- 1 Parameter Information
13.3 Sampling characteristics

Test Mode Sample Volume
Whole Blood mode 10 μL
Peripheral mode 10 μL
Prediluent Mode 20 μL
13- 2 Sampling characteristics
- 62 -
13.4 Performance index

Item Range
WBC 0～200.0×109/L
RBC 0～20.00×1012/L
HGB 0～300g/L
PLT 0～2000×109/L
HCT 0%~80%
13- 3 Performance index
13.5 Background Range

Item Range
WBC ≤ 0.2  109 / L
RBC ≤ 0.02 1012/ L
HGB ≤1g/L
HCT ≤ 0.5 %
PLT ≤ 10  109/ L
13- 4Background Range
13.6 Linear Range

Item Range SD
0～5.9×10 /L 9
(±0.3×109)/L
WBC
6.0～99.9×109/L ±5﹪
0～0.99×1012/L (±0.05×1012)/L
RBC
1.0～9.99×1012/L ±5﹪
0～99g/L ±2.0 g/L
HGB
100～300g/L ±2﹪
0～99×10 /L 9
(±8.0×109)/L
PLT
100～999×109/L ±10﹪
13- 5 Linear Range
13.7 ReagentRepeatability index

Test the sample for 11 times ,then use the results from the second to eleventh test to get
repeatability statistics.
Item CV Range
WBC ≤2.0﹪ (4.0～15.0×109)/L
RBC ≤1.5﹪ (3.5～6.0×1012)/L
- 63 -
Item CV Range
HGB ≤1.5﹪ (110.0～180.0g)/L
MCV ≤0.4﹪ (80.0～110.0)fL
PLT ≤4.0﹪ (100.0～500.0×109)/L
LYM﹪≥15.0﹪,
LYM﹪ ≤8.0﹪
WBC≥4.0×109/L
MID﹪≥5.0﹪,
MID﹪ ≤10.0﹪
WBC≥4.0×109/L
NEUT﹪≥30.0﹪,
NEUT﹪ ≤8.0﹪
WBC≥4.0×109/L
13- 6 Repeatability index
13.8 Pollution rate

Item Result
WBC ≤1﹪
RBC ≤1﹪
HGB ≤1﹪
PLT ≤1.5﹪
13- 7 Pollution rate
13.9 Input/Output
Touch Pen
Keyboard(Option)
Mouse(Option)
Printer(Option)
R232 Port
VGA Port
Internet Port
Power supply:
Voltage Frequency
Main Unit 100～240Vac 50/60 Hz
Work environment
Temperature: 18℃~35℃
Storage environment
Temperature: -10℃~40℃
- 64 -

This instrument should be placed at a good ventilation area.
Dimensions and Weight

Dimensions: 410mm×435mm×472mm
Weight: 25kg
Contraindication
None
- 65 -

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Operation Manual Edition:B/01

Chapter 1 Instrument Introduction ..................................................................................... 7

3.6.2 Procedures of Sample Count and Analysis ................................................. 27

8.12 Screen ................................................................................................................ 51

How to use the manual

Avoidance from potential hazard

Chapter 1 Instrument Introduction

Specimens in Table 1-1

• Standard Classification of the Instrument

Derived from Histogram:

Reagent Volumes Required for Single Sample:

Whole Blood and Peripheral Blood Mode:

Cell Counting Aperture Size:

Throughput: Up to 60 samples per hour

Working mode: Double counting pathway +independent HGB detection system

Precision Specifications of the instrument

Screen Display and the Range of Report Output Parameters

Dimensions and Weight

The display screen is shown as the figure 1-3.

The button functions are as follows:

The button in maintain window are as follows:

Add Diluent: Add 1mL diluent for prediluted mode.

 Patient and Other information

1.7 Detection Principle

1.7.1 Detection Principles of WBC, RBC, PLT

1.7.2 Principles of HGB Measurement

1.7.3 Volume Distribution of Blood Cell

1.7.4 Results and Calculation of Parameter Measurement

2.3 Installation Requirements

2.3.2 Space Requirement

2.3.3 Power Requirement

more than 0.5V

2.4 Reagent tubing connection

2.4.1 Lyse Connection

2.4.2 Diluent Connection

2.4.3 Waste Connection

2.5 Recorder Paper Installation

2.6 Printer Installation (Optional)

the rear panel of the instrument.

2.7 Power Cable Connection

Chapter 3 Sample Analysis

The button functions in blood cell analyzer window are as follows:

Jump to the first result. Jump to the last result.

Jump to the previous result. Jump to the next result.

3.2.1 Sample Mode

Figure 3-3 sample mode window

3.3 Background Test

3.4 Quality Control

3.5 Preparation for sample collection

3.5.1 Whole Blood Blood Collection

3.5.2 Peripheral Blood Collection

3.5.3 Prepare Samples in Prediluted Mode

3.5.4 Prepare Samples in Peripheral Mode

3.5.5 Sample Homogenization

sample be fully homogenized and ensure the accuracy of measurement.

3.6 Sample count and Analysis

3.6.1 Input Sample Information

3.6.2 Procedures of Sample Count and Analysis