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Instruction
Dear user, thanks for choosing our BF Series Automatic Hematology Analyzer (Model: BF-6500).
Please read the user manual carefully before use in order to operate the instrument correctly.
Please keep the user manual safely for your any time reference.
Version: REV.01-2016.
Warning
● An independent power supply is a must. Electromagnetism interference will affect the accuracy of the test
result.
● Do not pull the electrical wire with wet hand, or there is a risk of electrical shock.
● Do not trample, twist, drag the wire and cable, or it may cause fire. The damaged wire and cable cannot be
used.
● The input power should conform to instrument requirement. Specified fuse should be used.
● Make sure the switch is on [O] state before connecting the power.
● Do not touch moving parts when the instrument is testing to avoid accident.
● Non-professionals cannot open the left, right and upper cover of the instrument when the main power is ON.
● Make sure the instrument is used under the condition that is specified in user manual. In improper condition,
the instrument may not work well, the result may be inaccurate, instrument component may be damaged and
personal security is endangered.
● The protective measure may not be effective if the instrument is not operated according to the user manual.
Note
● Instrument should be operated by medical inspection specialist, physician, nurse or lab assistant who are
specially trained.
● Maintenance plan is needed for hospitals and inspection organizations. And the plan should be followed
strictly. Otherwise, instrument failure may occur.
● Instrument should be controlled by special software specified by the manufacturer. Other hardware or
software installation may affect the normal working of the instrument.
● Expired reagent cannot be used. The reagent should be protected from dust, dirt and bacteria once opened.
● Soft cloth or gauze can be used for cleaning work. A little diluted detergent and alcohol can be used if
necessary. Pine oil and benzene cannot be used for outside cleaning, it may cause color and shape change.
●When the transportation or storage temperature in winter is low or the relative humidity is more than 75%,
the instrument should be kept in the normal work environment for at least 24 hours before power on.
Biohazard
● Please dispose of the reagent, waste solution, waste samples and consumables according to the national or
local regulations.
● Please dispose of the waste solution and instrument consumables according to the regulations of medical
waste, infective waste and industrial waste. Blood in the waste may have been contaminated by pathogens.
●Blood samples, Control and Calibrator on the sampling probe may have potential bio-infectivity. Avoid
contact with the sampling probe. When aspirating a sample, there should be a certain distance between the
probe tip and the wall of the container to avoid blood splash. Otherwise the accuracy of aspiration volume may
be affected.
Statement
The manufacturer is responsible for the security, reliability and performance of the instrument after the
following requirements are met:
(1)Installation, debugging and repair are conducted by professionals from the manufacturer.
Content
I
User Manual
II
User Manual
III
User Manual
IV
User Manual
1.1 Overview
BF Series Automatic Hematology Analyzer (Model: BF-6500) is a highly integrated instrument with
high-capability. It characterize in accurate test result, easy operation, low consumable. The instrument can test
quantitative analysis result of 24 blood parameters. Instrument is connected with computer to conduct
operations.
The scope of the product: BF Series Automatic Hematology Analyzer is an in vitro diagnostic medical
instrument used by professionals for screening. It is used for testing red blood cell (RBC), platelet (PLT),
white blood cell (WBC) number and volume distribution and concentration of hemoglobin, and it offers
scattergram of white blood cell to help clinical diagnosis.
1.3 Specification
Model
Specifications
BF-6500
WBC, BAS#, NEU#, EOS#, LYM#, MON#, BAS%, NEU%, EOS%, LYM%,
Test Item MON%, RBC, HGB, MCV, MCH, MCHC, RDW-CV, RDW-SD, HCT, PLT,
MPV, PDW, PCT, P-LCR
Carry out five-part differential to WBC counting result; the instrument can test 24
Parameters parameter, offer 1 scattergram and 4 histogram; it will alarm when the abnormal
Basic condition of pathology and morphology occurs
Features
Sample injection
Manual sample injection
method
Stored sample volume The maximum test result of stored sample is 30000
Reagent type Four types in total, including a diluent and 3 types of lyse
WBC classification Cell chemical staining technology, sheath flow technology, optical analysis
Analysis principle method
System
Counting method Utilize impedance technology for WBC counting
Computer
Computer and printer (optional)
configuration
Data
System Interface RJ45 network interface
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Model
Specifications
BF-6500
Weight 46kg
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(3)Basophil Percentage
BAS #
BAS% = ´100%
WBC
(4)Lymphocyte Percentage
The number of cells Lym area of DIFF channel
LYM% = ´100%
The number of all cells in DIFF channel except ghost
(5)Neutrophil Percentage
The number of cells Neu area of DIFF channel
NEU% = ´100%
The number of all cells in DIFFchannel except ghost
(6)Monocyte Percentage
The number of cells Mon area of DIFF channel
MON% = ´100%
The number of all cells in DIFF channel except ghost
(7)Eosinophil Percentage
The number of cells Eos area of DIFF channel
EOS% = ´100%
The number of all cells in DIFF channel except ghost
(8)Lymphocytes
LYM # = WBC´ LYM%
(9)Neutrophil
NEU # = W BC ´ NEU %
(10)Monocyte
M ON # = W BC ´ M ON %
(11)Eosinophil
EOS # = WBC ´ EOS%
This testing and calculation process will be finished by the instrument automatically, and the result will be
displayed in the counting interface.
1.4.6 RBC / PLT Testing
1.4.6.1 Impedance Method
This instrument adopts the electric impedance method to count red blood cell / platelet. RBC / platelet sample
flow into RBC test unit after twice dilution. The testing unit has a test aperture. A pair of positive and negative
electrodes exists beside the aperture. As the cells have the characteristic of a poor conductor, when the cell go
through the aperture under constant negative pressure, the DC resistance between the electrodes will change,
resulting in the formation of a pulse signal which is proportional to the cell size. A series of electrical pulse is
produced when the cell continuously go through the aperture. The number of pulses is equivalent to the cell
number through the aperture. The pulse amplitude is proportional to the cell size.
Compare the amplified electric pulse with channel voltage value corresponding to normal RBC/PLT size range.
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Calculate the electrical pulse number. All electrical pulse is classified according to different channel voltage
value. Electrical pulse number which fell in RBC/PLT channel is RBC/PLT number. Cell number in each
channel which is divided according to pulse voltage range determines the cell size distribution. The
two-dimensional map with cell size as abscissa and cell number as vertical axis is the histogram reflects the
distribution of cell.
1.4.6.2 Size Testing Method
The precise control upon sample volume that goes though the aperture during testing is the premise of getting
accurate result. Quantitative injection pump ensures the sample volume that goes through the testing aperture
is tested. Sample volume is determined by the running steps of motor.
1.4.6.3 RBC Parameter
(1)RBC Number
RBC number is obtained through testing corresponding electrical pulse.
Unit: 1012/L
RBC=n×l012/L
(2)Mean RBC Size
Calculate mean RBC size according to RBC distribution histogram. Unit: fL
(3)RBC hematocrit, mean RBC hemoglobin content, mean RBC hemoglobin concentration
Calculate RBC HCT according to the following formula, unit %; mean RBC hemoglobin content (MCH), unit
Pg; mean RBC hemoglobin concentration (MCHC), unit g/L.
RBC´MCV
HCT =
HCT 10
HGB
MCH =
Mean hemoglobin content RBC
HGB
MCHC = ´100
Mean hemoglobin concentration HCT
RBC Unit: 1012/L, MCV Unit: fL, HGB Unit: g/L
(4)RBC Distribution Width Variation Coefficient
RDW-CV is obtained through RBC distribution histogram. The volume distribution variation coefficient is in
the form of percentage.
(5)RBC Distribution Width Standard Deviation
RDW-SD is histogram width relative to RBC distribution histogram peak (20%), unit fl, as shown in Figure
1-4-10.
Figure 1-4-10
(6)RBC Distribution Histogram
The RBC volume distribution histogram is offered when the result is obtained. The graph that can indicate the
distribution of cell population is RBC distribution histogram. Histogram abscissa is RBC size (unit: fl), vertical
axis is RBC relative number (unit: 1012/L). After each counting, RBC distribution histogram can be obtained in
analysis result area of counting interface. RBC distribution histogram can also be obtained through entering
search interface.
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1 Front Door 2 Indicator(yellow-failure status indicator, green-running status indicator, red-power indicator from left to right)
3 Sampling Probe 4 Sample Aspiration Key
Figure 1-5-1 Front Picture
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1 Internet Access (RJ45) 2 Float Sensor Port 3 Power Supply 4 Power Switch
Figure 1-5-3
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1.7 Symbol
Table 1-7-1
Symbol Meaning
BIOLOGICAL RISKS
ALTERNATING CURRENT
BATCH CODE
USE BY
SERIAL NUMBER
DATE OF MANUFACTURE
PROTECTIVE GROUND
MANUFACTURER
CATALOGUE NUMBER
“ON”(POWER)
“OFF”(POWER)
The above symbol information is included on the instrument, reagent strips, and Control.
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Chapter2 Installation
To ensure the normal working of the instrument after installation, the initial installation and set-up of the
instrument should be carried out by authorized personnel of the manufacturer.
Dedicated computer software should be used for controlling. It is recommended that the software and
database is not installed in system disk.
Do not install the instrument at the place where is far away from the disconnection device.
2.1.2 Power Requirement
(1)Power Supply: 100V-240V~ 50/60Hz.
(2)Power Consumption: 175VA.
(3)Fuse: F4AL250V 5mm×20mm.
(4)Large load equipment like air conditioner, refrigerator, oven etc. should not be inserted in the same outlet.
A good grounding is must.
2.1.3 Environmental Requirement
(1)Environment Temperature: 18℃-30℃.
(2)Relative Humidity: ≤75%.
(3)Atmospheric Pressure: 75kPa-106kPa.
(4)The instrument should be protected from dust, mechanical vibration, significant noise and power
interference.
(5)It is recommended that the electromagnetic environment assessment of the laboratory should be conducted
prior to test.
(6)Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may
interfere with the proper working.
(7)It should be placed far from the constant ON-OFF electrical devices like brush-type motor, fluorescent
lamp.
(8)It should be placed far from heat and wind source, sunlight, brush-type motor, flickering fluorescent light
and electrical contact equipment.
(9)A well-ventilated place is a must; if necessary, a ventilation device can be used. Direct blowing should be
avoided; otherwise this may affect the test accuracy.
The result will be unreliable if the room temperature or power cannot meet the requirement. Or cause
instrument damage and endanger personal safety.
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2.2 Unpacking
2.2.1 Unpacking Procedures
Upon arrival of the Analyzer, please check the package for intactness. In case of any physical damage, please
contact the manufacturer 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
component is missing or not. If any component is missing, please contact the manufacturer or local agents
2.2.2 Transportation Method
(1)Remove the reagent bottle and waste tank at the back of the analyzer prior to transportation.
(2)Ensure that the used Analyzer has gone through “Empty Pipeline” before transportation.
(3)Utility cart and the like are available for smooth and short-distance transportation.
(4)When moving and transporting, prevent the display on the front panel and the sampling probe from being
applied with external force, contacting other goods and damaging.
(5)When moving and transporting, always keep the Analyzer upright. Inclination and side laying are not
allowed.
(6)During transportation, avoid vibration as far as possible. After transport, examine and debug the Analyzer
before usage.
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● Waste liquid should be disposed of according to relevant local medical waste treatment regulations.
● The water discharge system should conform to the waste water discharge requirements for local
medical institutions.
(3)Computer Connecting
Connect “Net Port” of computer host with “Net Port” of right side instrument (1 of Figure 1-5-3).
(4)Power Wire Connecting
Connect one end of supplied power line with the attaching plug on the back side of the instrument (3 of Figure
1-5-3). And connect the power line of host, display and printer.
The light beam of the barcode reader may hurt eyes, therefore, staring should be avoided.
(6)Printer Connecting
Connect the printer and the computer host through data wire.
a)Whether the printer driver is installed.
b)Check the printing paper specification.
Screws will be used for fixing sampling probe before delivery. Screws should be removed before power
on; otherwise, probe may be damaged, as figure shows:
Spacer
Screw 1, 2
Figure 2-3-2
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Screw 3
Figure 2-3-3
After installation, screw 1, screw 2 and spacer of Figure 2-3-2, screw 3 of 2-3-3 should be moved; otherwise,
the probe might be damaged after power on.
2.3.2 Software Installation
The software has been installed by the manufacturer’s professionals before delivery. User should not uninstall
it except abnormity occurs. In case of a must-uninstall, please follow the following steps:
2.3.2.1 Operating Part
The software system is installed on the computer to constitute the operating part of the instrument. The
operating part consists of the host, 21.5 inch display, keyboard, mouse and printer.
Host: 32 bit English Windows 7 operating system, upper computer software environment installation package,
and upper computer software are installed.
Basic configuration: CPU clock speed≥2.8GHz, hard disk drive≥250G, memory≥2G, network interface (two
are better), and USB interfaces.
Display: Display each window, curve, and test data of the instrument software. Resolution≥1366×768.
Keyboard: Perform the instrument operation control and data input.
Mouse: Perform software operation.
Printer: Print test data and diagrams.
2.3.2.2 Computer Setting
(1)IP Setting
Click【Start】→【Control Panel】→【Network and Sharing Center】, select 【Change Adapter Settings】 from
the guide column on the left, open 【Local Connection】, select 【Properties】, and double-click 【Internet
Protocol Version 4(TCP/IPv4)】, as the following figure shows:
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Figure 2-3-4
“XXX” in IP address “172.16.100.XXX” includes but not limited to the number as the above figure shows.
Any number within 【1—255】 except 138 can be input.
Figure 2-3-5
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Figure 2-3-6
Click “Install” in the above figure, and the following figure will pop up:
Figure 2-3-7
Click “OK” in the above figure, after restart the Microsoft SQL Server 2005 can AutoRun Installation, as
Figure 2-3-8 shows:
Figure 2-3-8
Click “Next” in the following pages until the page – Figure 2-3-9 shows:
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Figure 2-3-9
Continue to click “Next” until the installation completes. After install SQL2005, it will auto-run the
installation of VC++2008, as Figure 2-3-10 shows:
Figure 2-3-10
VC++ installation completes, as Figure 2-3-11 shows:
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Figure 2-3-11
At last, appearing the following tip illustrates the PC system environment is installed successfully. Then you
can install the upper computer software, as Figure 2-3-12 shows:
Figure 2-3-12
When the above installation has been finished, run upper computer installation program, the installation
interface will pop up, as Figure 2-3-13 shows:
Figure 2-3-13
Click “Next” in above figure, select the installation path, the default path is C:\Program Files\(It is suggested
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that the program should not be installed in C:\, it can be installed in other disks.), meanwhile, all the users have
the permission to install the program by default. As Figure 2-3-14 shows:
Figure 2-3-14
Click “Next” in above figure, the confirm interface will pop up, as Figure 2-3-15 shows:
Figure 2-3-15
Click “Next” in the above figure, the process bar will pop up, as Figure 2-3-16 shows:
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Figure 2-3-16
Click “Next” after installation has been finished, Figure 2-3-17will pop up:
Figure 2-3-17
Click “Close” in above figure to finish the installation of the software. The shortcut of the program will be
displayed on the table after installation.
If the upper computer is installed in the C:\, it is needed to modify the properties of the installation directory
after the upper computer installation steps complete. If the upper computer is installed in the other disks, the
properties do not need to be modified. Details are shown as follows:
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Figure 2-3-18
Click “Security” button on the above figure, as following Figure 2-3-19 shows:
Figure 2-3-19
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Figure 2-3-20
Click 【Users】 key on above figure, and add security control permissions, that is to say, sign “ ” in
“Permissions for Users” line of “Full control”, then click【Apply】,【OK】 key to save setting.
Figure 2-4-1
Click “Yes” to finish the uninstallation.
Turn on the power switch of the instrument, login the application software.
2.5.1 Login Software
Double click the application software icon , or click “Start”, find the software in “Program” window,
enter into “System Login” window, as Figure 2-5-1, 2-5-2 shows:
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Figure 2-5-1
Figure 2-5-2
Input username, password, the initial user name is Admin (cannot be modified), the initial password is 1. If the
input username or password is wrong, the screen will display login error, as figure 2-5-3 shows:
Figure 2-5-3
Input username, password in Figure 2-5-2, and click “ ”. to enter the “Component Maintenance”
interface as shown in figure 2-5-4.
Figure 2-5-4
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In the initial login, the checkbox “Automatically turn off after 3 seconds” in the “Component
Maintenance” screen is selected as default, you can cancel selection as required; If cancel, you need to
manually close the window. These operation will take effect when next logon.
When the “Component Maintenance” interface was closed, the screen will display “System self-testing…”.
Then the instrument starts to check the flow path, temperature and background as the figures shown below:
Figure 2-5-5
Figure 2-5-6
Click in Figure 2-5-6 after self-test to enter into main interface, as Figure 2-5-7 shows:
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Figure 2-5-7
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: Printer is disconnected.
: Printer is working.
2.5.2.3 Public Information Area
Bottom of the counting interface is the public information area, as figure 2-5-8 shows:
Figure 2-5-8
(1)Failure Information Area:
The corresponding failure information will be displayed in this area when failure occurs. Click this area, the
failure dialog box will pop up, as Figure 2-5-9 shows:
Figure 2-5-9
Click the corresponding information, the detailed solution will be displayed in “Detail Information”
(2)X-B QC Switch Status:
Use icon to indicate the switch status of X-B QC. With X-B is ON, without X-B is OFF.
(3)Test Status: Indicates the test status.
(4)Sample Information: Display the analysis mode and test mode.
Analysis Mode: There are two modes. Whole blood mode and pre-diluted(peripheral blood).
Test Mode: There are two modes.【CBC】and【CBC+DIFF】.
(5)Rinse Times: 3 in 3/200 indicating the tested sample number from the last time rinsing. 200 represents the
rinsing interval (set in Setting-Automatic Rinsing Setting).
The manual rinsing method is as follow:
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Figure 2-5-10
Click in the above figure, and the status bar displays “Rinsing instrument”. When carrying out
the automatic rinse, the main menu is shown as Figure 2-5-11. Only “Log” can be viewed. In the shortcut key
area, only “Data Browse” and “Data List” can be used. The user can edit patient information and view test
results.
Figure 2-5-11
Click in Figure 2-5-7 to enter “Exit System” window, as Figure 2-5-12 shows:
Figure 2-5-12
● Log off is recommended when the user is at rest. For avoiding non-user damage software or modify
the data. Periodical database backup is recommended to avoid data lose caused by unforeseen
circumstances.
● Input the initial user name and password in the first login. Set the user name, permission and
password in “User Setting” after login for next login.
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Figure 3-1-1
Analysis Mode: There are two modes. Whole blood mode and pre-diluted (peripheral blood) mode.
Sample No.: What entered here is the number of the next analytic sample.
● Sample No. with “-” is accessible. “.” is NOT accessible (“Sample No. Error” will be prompted if there
is “.”).
● The entered number of the sample to be tested cannot repeat the one of the already-tested or -edited
sample. Otherwise, the new record will replace the former one.
Reference Range: Click the drop down list of “Reference”, general, man, woman, child, infant and
user-defined can be selected.
Test Mode: There are two modes.【CBC】conduct counting without diff upon WBC, counting result includes
histogram and its parameter of WBC, RBC and PLT.【CBC+DIFF】conduct counting and differential upon
WBC, includes 24 parameters and scattergram, histogram.
Click of main interface shortcut and the following figure pops up:
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Figure 3-2-1
If the lock button is in the locked status, patient information can be edited or modified.
Figure 3-2-2
Default Value: This value is default when editing other sample information.
Remember: If , the last edited sample information will be remembered when editing other information.
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is enabled, click “Add” in the data browse interface, the added user information will display in accordance
with the settings.
Click when “Default Value”, “Remember” and “Ignore” have been set. The mouse will move to
the input box of sample No. in Figure 3-2-1 to edit patient information.
3.2.1.1 Sample Information
(1)Sample No.: Set the next sample No. manually.
(2)Barcode No.: Can be input manually or by scanning.
(3)Sample Time, Deliver Time: Select “Present Time” or “Blank” from the “Sample Time” and “Deliver
Time” pull-down menu in Figure 3-2-1. If “Present Time” is selected and the corresponding time is clicked,
time can be manually input for the setting.
(4)Reference: Double click the input box behind “Reference” in Figure 3-2-1; the following box will pop up:
Figure 3-2-3
Input the corresponding memoni in the input box of “System Code Selection”, or click the line of
corresponding item (“Setting” of main menu→ “Information” to set the commonly used ID).Click
.The reference range of test items includes general, man, woman, child, newborn and 5 user
define.
3.2.1.2 Patient Information
(1)Case No.: Input the case No. in Figure 3-2-1.
(2)Name: Input the patient name directly.
(3)Sex: Double click the input box behind “Sex” in Figure 3-2-1; the following box will pop up:
Figure 3-2-4
Input the corresponding memoni in the input box of “System Code Selection”, or click the line of
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corresponding item (“Setting” of main menu→ “Information” to set the commonly used ID).Click
.
(4)Age: Input the patient age and double click the input box of age unit, the following box will
pop up.
Figure 3-2-5
Input the corresponding memoni in the input box of “System Code Selection”, or click the line of
corresponding item (“Setting” of main menu→ “Information” to set the commonly used ID). Then click
.
The reference value cooperates with age and sex. After selecting sex, inputting age and selecting age unit, the
reference value will be adjusted automatically. Infant≤28 days, 28 days<child≤13 years old, 13 years old<
general. If the input age is more than 13 and sex is male, the reference value is male by default, if the input age
is more than 13 and sex is female, the reference value is female by default.
Figure 3-2-6
Input the corresponding memoni in the input box of “System Code Selection”, or click the line of
corresponding item (“Setting” of main menu→ “Information” to set the commonly used ID). Click
.
(6)Bed No.: Click the input box of “Bed No.” in Figure 3-2-1 or input it directly.
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(7)Deliver: Input it directly or double click the input box of “Deliver”, the following figure will pop up:
Figure 3-2-7
Input the corresponding memoni in the input box of “System Code Selection”, or click the line of
corresponding item (“Setting” of main menu→ “Information” to set the commonly used ID).Click
.
(8)Remark: the remark information after test can be input(can be input directly).
Press enter to save the information when all the information has been finished.
3.3 Setting
3.3.1 Normal User
Click “Setting” in main menu, as shown in Figure 3-3-1:
Figure 3-3-1
YYYY-MM-DD, MM-DD-YYYY, DD-MM-YYYY, select one of them and press , the following
information will be displayed:
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Figure 3-3-2
Press to save the changed date format. Press to exit the interface.
The changed date will be displayed in all positions with time (such as delivery time, sampling time, etc.).
3.3.1.2 Language Setting
Click “Language Setting” in Figure 3-3-1, as Figure 3-3-3 shows:
Figure 3-3-3
Click the drop-down menu behind “Select Language”, select the language, click , the tip “Saving
Succeed” will pop up, click to finish the language setting.
3.3.1.3 User Setting
Click “User Setting” in Figure 3-3-3, as Figure 3-3-4 shows:
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Figure 3-3-4
Only the password can be modified when the user login as common user. Click in Figure
3-3-4, as Figure 3-3-5 shows:
Figure 3-3-5
Input the new password and old password (the two passwords must be same), click to finish the
modification.
User edition, addition and deletion cannot be conducted when the user login as common user.
3.3.1.4 Reagent Validity Setting
Single click “Reagent Validity Setting” in Figure 3-3-4, as Figure 3-3-6 shows:
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Figure 3-3-6
Click the drop down box of corresponding item, select the validity according to the reagent instruction, press
, the tip “Saving Succeed” will pop up, click to finish the setting. Click
to exit the interface.
Figure 3-3-7
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Figure 3-3-8
Control method, calculation method and range of L-J/X-bar QC can be selected in Figure 3-3-7.
ON/OFF and sample No./group of X-B QC can be set in Figure 3-3-8.
3.3.1.6 Print Setting
Click “Print Setting” in Figure 3-3-8. Printer name, header icon, title of sample and QC , and report type can
be set in Figure 3-3-9.
Figure 3-3-9
(1)Printer: Select the printer in its drop-down list.
(2)Report Default Icon: Report pageheader icon can be set. Click , the dialog box of picture
path will pop up. Select the picture(picture size is 34*34, format can be BMP or JPG).
Click to clear the pageheader icon. The icon will not be displayed in report preview.
(3)Sample: Headline, pagefooter and print report format can be input in this unit.
a)Headline: Delete the original headline and input new headline if headline need to be changed.
b)Page Footer: The page footer is user-defined, e.g. “This report is only responsible for the delivered
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sample.”
c)Print Report Type: Select the type in its drop-down list. Click to preview the format.
(4)QC: The headline and print report format can be input in this unit.
a)Headline: Delete the original headline and input new headline to change it.
b)Print Report Type: Select the print type in its drop-down menu, and click to preview the
format.
(5)Report Designer: User can design report type.
Refer to “Appendix B” for its using.
(6)Print clogged aperture mark: in case that “Print clogged aperture mark” is ticked, if the report data is with
clogged aperture, there is the clogged aperture mark (?) on the printed report; in case that it is not ticked, if the
report data is with clogged aperture, there is no the clogged aperture mark (?) on the printed report.
(7)Print Research Parameter: when “Print Research Parameter” is ticked, “Input microscopic examination
result” will display in the interface, as following figure shows:
Figure 3-3-10
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Figure 3-3-11
Select “ON” or “OFF”, then click “Save”.
Selecting “ON”, in the process of test, the aperture is clogged, the instrument will re-test automatically.
Selecting “OFF”, in the process of test, the aperture is clogged, the instrument will alarm, “Aperture is clogged,
perform clog removal or rinsing aperture”.
3.3.1.8 Automatic sleep time
Click “Automatic sleep time” in Figure 3-3-9, the automatic sleep time of the instrument can be set, the range
is [10, 120], as Figure 3-3-12 shows:
Figure 3-3-12
Admin is system default administrator username. Default password is 1. The password can be modified,
but cannot be deleted.
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Figure 3-3-13
Figure 3-3-14
(1)Add User:
Figure 3-3-15
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Input the username needing to be added in the input box behind “Username”. Click to , which is in front of
“Audit Permission” if the user needs audit permission, To entitle “Admin Permissions” to added user, click
radio box before “Admin Permissions”(like this “ ”, and entitle “Audit Permissions” to added user
meanwhile), and click to finish the user adding.
Click after username input if this user does not need audit permission or administrator.
● The initial password of the new user is “1”, which can be modified after login.
● The name of new user cannot be empty or same as other username.
(2)Delete User:
Click the line of common user in Figure 3-3-14, the selected line will turn into blue, the interface is like
3-3-16:
Figure 3-3-16
Figure 3-3-17
Click the line of common user in Figure 3-3-16, click , the interface is like 3-3-18:
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Figure 3-3-18
The audit permission of common user can be edited again. Select the radio in front of “Audit Permission” to
give the permission to the user. Click the radio box again to cancel the permission.
User’s admin permission can be reset. To entitle admin permission to user, select radio box before【Admin
Permission】. To delete user’s audit permission, cancel radio box before【Admin Permission】. This user will
become general user.
(4)Modify Password:
The password of the administrator and common user can be modified by administrator.
Click the line needs to be modified in Figure 3-3-16, click , the interface is like 3-3-19:
Figure 3-3-19
Figure 3-3-20
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Figure 3-3-21
IP and port of LIS computer can be set. ON/OFF status of “Auto-communication” can be selected. ON/OFF
status of “Translate data after clog” can be selected.
3.3.2.3 Unit Setting
Click “Unit Setting” in Figure 3-3-21, as Figure 3-3-22 shows:
Figure 3-3-22
Single click the input box behind items and select the units. Click after input. Click
when “Saving Succeed” is prompted. Click “Default Value” to restore the setting when the unit
has been modified accidentally. “Default value setting succeeded” indicates successful setting.
The units are as follow:
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Table 3-1-1
103/μL ***.**
WBC
2
10 /μL ****.*
/nL ***.**
9
LYM#, MON#, BAS#, EOS#, NEU# 10 /L ***.** Default Unit
/pL **.**
mmol/L **.*
mmol/L ***.*
% **.*
HCT
L/L *.*** Default Unit
/nL ****
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Figure 3-3-23
Upper, lower Limit of Reference Input:
Click the input box of upper and lower limit to input the values.
Click after input. Click after the prompting of “Saving succeeded” to finish the
saving.
The following box will pop up if the input lower limit is greater than the upper limit, or the input reference is
not within the set range.
Figure 3-3-24
Input again after checking if the above box is prompted.
Click “Default Value” to restore the setting when the reference has been modified accidentally. “Default value
setting succeeded” indicates successful setting.
Figure 3-3-25
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Figure 3-3-26
a)Add Department Information: Input the department name in the input box behind name. Input the
commonly used memoni in the input box behind ID, click .
b)Delete Department Information: Select the items need to be deleted in the department information list,
click .
(2)Doctor Information Setting:
Select the “Doctor Information” in the drop-down list of “Information Type”, as Figure 3-3-27 shows:
Figure 3-3-27
a)Add Doctor Information: Input the doctor name in the input box behind name. Input the commonly used
memoni in the input box behind ID, click .
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b)Delete Doctor Information: Select the items need to be deleted in the doctor information list, click
.
(3)Reference Selection:
Select the “Reference” in the drop down list of “Information Type”, as Figure 3-3-28 shows:
Figure 3-3-28
Select “General”, “Man”, “Woman”, “Child”, “Newborn”, “User Define 1”, “User Define 1”,“User Define 2”,
“User Define 3”, “User Define 4” and “User Define 5” in reference list. Only the commonly used ID of
reference can be modified here, but not the name or add other reference.
(4)Sex Selection:
Select “Sex” in the drop down list of “Information Type”, as Figure 3-3-29 shows:
Figure 3-3-29
Select “Male” or “Female” in the sex list. Only the commonly used sex ID can be changed here.
(5)Age Unit Selection:
Select the “Age” in the drop down list of “Information Type”, as Figure 3-3-30 shows:
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Figure 3-3-30
Select “Years Old”, “Month”, “Day” or “Hour” in the list of age unit. Only the commonly used age unit ID can
be changed here.
(6)Cost Category
Select “Cost Category” in the drop down list of “Information Type”, as following figure shows:
Figure 3-3-31
a)Cost category information addition: input cost category name in the Name input box, input mnemonic in
the ID input box, and then click “Add”.
b)Cost category information deletion: select the item to be deleted in the cost category information list, and
then click “Delete”.
3.3.2.6 Backup Setting
Select “Backup Setting” in Figure 3-3-30, as Figure 3-3-32shows:
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Figure 3-3-32
(1)Backup:
Periodical database backup can prevent data lose.
Single click to backup the document into the folder. The default saving path is “backup”of
software installation. The folder name is the current date+time+*.bak. Click for saving.
(2)Data Recovery:
The backup data can be used to recover the previous data if software cannot be used for some reason. Select
the saving path of backup folder before recovery. And select the document according to the backup date and
time.
3.3.2.7 Automatic Rinsing Setting
Click Automatic Rinsing Setting. Then the following figure will pop up:
Figure 3-3-33
(1)Input automatic rinsing interval times in the input box of counter “Count Times” (between 10-200). The set
number is 100 which means automatic rinsing will be conducted after each 100 samples. The number will be 0
after rinsing.
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(2)Input rinse DIFF pool interval times in the input box of rinse DIFF pool “Count Times” (between 10-600).
The set number is 10 in the above figure, which means when the test times is no less than 10, DIFF pool
rinsing will be conducted before sleep (The software displays “Rinsing the instrument…”), then the instrument
will enter into sleep mode (in case of not conducting shutdown and manual rinse of the instrument in the
process of test).
3.3.2.8 Abnormal Mark Setting
Click “Abnormal Mark Setting”, select “WBC”, as the figure below shows:
Figure 3-3-34
Select “RBC/PLT”, as the figure below shows:
Figure 3-3-35
The prompt range of WBC, RBC/PLT abnormal alarm information can be set in this interface.
Click for saving after input, click “Default Value” to recover, click to cancel the
interface.
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Chapter4 Calibration
Calibration of the instrument is to ensure the accuracy of the results. Calibration must be carried out before
test.
Figure 4-3-1
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Figure 4-3-2
After obtaining 3 or more counting results, the instrument will carry out CV and calibration coefficient
calculation and save the calibration coefficient result. Save after 5 times counting is recommended. As the
increase of calibration times, CV and calibration coefficient will be updated.
The following box will pop up if the results obtained beyond the scope.
Figure 4-3-3
Click “OK” to close the box and clear the result of this counting. The result will be displayed on the calibration
interface only if the counting result is valid.
When saving the counting result after obtaining 3 or more counting result, if the calibration coefficient of
certain parameter is not within 75%-125%, click “Save”, the following box will pop up:
Figure 4-3-4
Operator should check the reference value input, if the reference value input is correct, operator delete
calibration results, re-run the calibration count.
(3)Calibration Result Deleting:
If any abnormal result occurs, click “Test Result” on the left after test, × will be marked, indicating this result
is not counted during CV, mean, calibration coefficient calculation. If this result deletion is not needed after
test, click “Test Result” again (mark √ ) , indicating this test result is valid.
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Figure 4-3-5
Click “OK” to save the calibration coefficient. It will be stored into calibration coefficient of “Manual Calib”
interface. As Figure 4-3-6 shows:
Figure 4-3-6
Fresh blood calibration needs to be conducted under “Whole Blood” testing mode.
Click “Fresh Blood Calib” in Figure 4-3-1 to enter fresh blood calibration interface, as shown in Figure 4-4-1.
Figure 4-4-1
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(1)Select the number of fresh blood calibration in the drop down list behind “No.” To reselect its “No.” after
each fresh blood sample is tested for 5 times.
(2)Put the prepared fresh blood in the instrument to test three times, and calculate the mean value. The mean
value will be taken as reference value and input in Figure 4-4-1.
(3)Put the fresh blood under sampling probe, and press “Sample Aspiration”, the sampling probe will aspirate
20μL fresh blood and start calibration counting automatically.
Figure 4-4-2
(4)After obtaining 3 or more counting results, the instrument will carry out CV and calibration coefficient
calculation. 5 times counting is recommended. As the increase of calibration times, CV and calibration
coefficient will be updated.
(5)The instrument will carry out different process according to different results.
The following box will pop up if the results obtained beyond the scope.
Figure 4-4-3
Click “OK” to close the box and clear the result of this counting. The result will be displayed on the calibration
interface only if the counting result is valid.
When saving the counting result after obtaining 3 or more counting result, if the calibration coefficient of
certain parameter is not within 75%-125%, click “Save”, the following box will pop up:
Figure 4-4-4
Operator should check the reference value input, if the reference value input is correct, operator delete
calibration results, re-run the calibration count.
(6)Calibration Result Deleting.
If any abnormal result occurs, click “Test Result” on the left after test, × will be marked, indicating this result
is not counted during CV, mean, calibration coefficient calculation. If this result deletion is not needed after
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test, click “Test Result” again(mark √ ), indicating this test result is valid.
If this result is invalid, click “Delete” to delete the result.
(7)Calibration coefficient saving:
Click “Save” in Figure 4-4-1 after 5 times counting, the following box will pop up.
Figure 4-4-5
Click “OK” to save the calibration coefficient. It will be stored into calibration coefficient of “Manual Calib”
interface.
Figure 4-5-1
Click the corresponding line under “Calibration Coefficient” when the calibration coefficient needs adjustment,
and input the calibration coefficient, click “Save”, “Save succeed” will pop up, click “OK”.
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Figure 4-6-1
The date, mode, calibration method and detail test value of latest 100 times calibration will be displayed. If
calibration counting is more than 100 times, the previous calibration result will be covered.
Query: Operator can query the calibration log according to log date, username, calibration mode and
calibration method.
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5.1 L-J QC
Under “L-J” QC, the operator can carry out quality control of 24 parameters. The instrument provides 12 QC
documents in order to save quality control parameter and result. Each quality control document can save up to
400 groups of quality control results. When the number of quality control is more than 400, the new QC result
will cover the old result.
Click “QC” of main interface and select “L-J/Xbar” in , as shown in Figure 5-1-1.
Figure 5-1-1
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Figure 5-1-2
(1)Select Document No.
Click the drop down list of document No. to select the document needs QC, the range is 1~12.
(2)QC Lot No. Input:
Input the corresponding Control lot No. in the drop-down list of “Lot No.” according to Control instruction.
(3)Validity Setting:
Click the drop down list of “Validity” to input the validity according to the instruction.
(4)QC Level Selection:
Select QC level (High, Mid, Low)in drop down menu of “Level”. Each lot No. corresponds to one level.
Click “Save” when above input is completed. “Saving Succeed” will pop up, and click “OK”.
(5)Target Value, SD Input:
Input the target value and SD according to the QC instruction.
The input lot No., validity should be the validity marked on the instruction.
5.1.1.2 Preset Value
The QC result in QC chart can be used to calculate Mean, SD and CV%. In QC edit, it can be used as preset
value.
(1)Deviation Limit Setting
If the display form of deviation limit or calculation method of deviation limit in pre-set value need to be
adjusted, following these steps:
Click “Set” in main menu, select “QC Setting” in its left, as Figure 5-1-3 shows:
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Figure 5-1-3
Calculation method and range selection of deviation:
When “Absolute Value” calculation method is selected, the input deviation limit will be displayed in the form
of absolute value. “Range” will use two times the standard deviation (2SD) or 3 times the standard deviation
(3SD) as the deviation limit;
When “Percent” calculation method is selected, the input deviation limit will be displayed in the form of
percent. “Range” will use 2 times the variation coefficient (2CV) or 3 times the variation coefficient (3CV) as
the deviation limit.
Click “Apply” in Figure 5-1-3, the preset value is obtained according to the set method, and it is taken as the
target value and deviation limit of current QC document. The corresponding position of the parameter will be
displayed in Figure 5-1-2.
(2)Delete Abnormal QC point
If abnormal QC point occurs, preset value can be obtained after abnormal point deleting. The operating steps
are as follow:
Figure 5-1-4
Click “OK” of above figure, the screen will be switched into QC interface, as Figure 5-1-5 shows:
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Figure 5-1-5
a)If the second point on the left is abnormal point, click it, the red cursor line is on the second point, click
“Delete”, the selected point will turn into “Blue”. Use the same method to delete the abnormal points. The
blue point will not be counted during calculation.
b)Click “Calculation” after the points are deleted, the screen will return to “Setting” interface, and the result
will be displayed.
c)If the valid QC point number is less than 3, click “Preset Value”, Figure 5-1-6 will pop up:
Figure 5-1-6
d)If the above operation is found to be wrong, click the deleted point, and click “Add”, the blue point will
turn into red or green(normal point).
Valid QC points are taken as reference and deviation limit when taking preset value.
5.1.2 QC Counting
Click QC count in Figure 5-1-5 to enter QC counting interface, as shown in Figure 5-1-7.
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Figure 5-1-7
The specified Control of the manufacturer should be used to avoid QC result error.
See the instruction for the use of Control.
The result will not be reliable when the instrument failure occurs.
(1)QC Counting
Ensure the mode is “Whole Blood”.
Place the mixed Control under the sampling probe. Press “Sample Aspiration” to start QC counting. The
sampling probe will aspirate 20μL Control automatically to conduct QC counting.
Figure 5-1-8
The result will be displayed on the screen.
If the result is lower than the lower limit of the software or higher than the display range, the following box
will pop up:
Figure 5-1-9
Click “Cancel” in above figure, this result will be deleted.
(2)QC Data Query
The stored QC result can be queried through button “Next” and “Previous” under “Position/Total Number”
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after QC counting. If QC results are out of QC ranges, red is displayed in corresponding columns.
(3)QC Data Modification
After QC tests, if the results need to be modified, double-click them, and then make modification, click “Save”
button to save modified results.
(4)QC Data Print
To print single QC results, click “Print” button to print current records.
(5)QC Data Deletion
To delete current QC results, click “Delete” button to delete current records.
5.1.3 QC Result Review
Click QC Graph in Figure 5-1-7 to enter the review interface, as shown in Figure 5-1-10:
Figure 5-1-10
(1)QC Graph Setting:
Click Setting in “QC Graph” interface to set the parameters or move the display position, as Figure 5-1-11
shows:
Figure 5-1-11
a)QC Item Setting:
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Select the parameter name in Figure 5-1-1, click “OK”, only the selected parameter will be saved.
b)QC Item Moving:
If the parameters need to be moved, select the parameter need to be adjusted(the selected line is blue), click
“Move Up”, “Move Down” to move the selected parameter.
(2)Explanation of QC result review interface:
If QC counting number is less than 3, the right side of QC chart will not display the QC result.
The abscissa indicates the QC counting number. The vertical axis indicates QC counting result.
Vertical line marked for the same set of counting data. For each parameter, its QC chart can display up to 400
points.
For each parameter, the three numbers on the left of the QC chart correspond to the three boundaries of QC
chart. From top to bottom, they represent the upper limit, target value and lower limit.
Upper limit: Control reference value + deviation limit
Target value: Control reference value
Lower limit: Control reference value - deviation limit
For each parameter, the three numbers on the right of the QC chart represent Mean, SD and CV% respectively.
(3)Point explanation of QC chart
The points are QC results, they are connected by lines.
“Green Point” indicates the QC result is within the range. “Red Point” indicates the QC result is not within the
range.
(4)If the point is not within the range, conduct the following steps.
Check the target value and deviation limit.
Check whether the background test is normal.
Conduct QC again if the above two points are normal. If abnormity remains, conduct QC counting after
calibration.
Contact the manufacturer’s after sales service department if abnormity remains after calibration.
(5)QC chart printing:
Click Print in Figure 5-1-10, if “Preview before print” is selected in print setting, preview can be conducted
before printing, as the following figure shows:
Figure 5-1-12
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QC graph query: select “Start date” and “End date”, and then click “Query” to check the corresponding QC
graph.
5.1.4 QC List
Different QC documents can be queried.
Click “QC List” in Figure 5-1-10, and select the QC document No. in the drop down menu of “Document No.”
to enter the interface of Figure 5-1-13:
Figure 5-1-13
(1)Delete All: The operator can delete all QC results of current QC document.
Click “Delete All” in Figure 5-1-13, as Figure 5-1-14 shows:
Figure 5-1-14
Click “Yes”, the interface will display “Delete Succeed”, which indicates that all QC results are deleted.
(2)Delete: The operator can delete some QC results of current QC document.
Select the QC data need to be deleted in figure 5-1-13, click “Delete”, as figure 5-1-14 shows, click “Yes”, the
interface displays “Deleting Succeed”, which indicates the selected QC results are deleted.
(3)Export: The operator can export the QC counting result of current QC document.
(4)Import: the operator can import the QC counting result.
(5)Communicate: The operator can transmit the QC counting result of current QC document to LIS.
5.2 X QC
X QC: the mean value of two testing result will be one QC point in the QC chart.
The operation is same as “5.1 L-J QC”.
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5.3 X-B QC
X-B floating average method is proposed by Dr. Brian Bull. It monitors instrument performance through
monitoring stability of red blood cell parameters, such as MCV, MCH, MCHC, etc. It belongs to the quality
control without control. Together with the quality control with control, they all belong to instrument
performance monitoring method which can reflect instrument performance from different aspects. They are not
mutually replaceable. The X-B quality control is recommended when the daily sample is greater than 100 per
day. This quality control method requires the use of random sample; therefore, the classified sample is not
suitable. It offers the upper and lower limit to form a reference range. Observe the changing trend of result
within the reference range.
This instrument conducts X-B QC toward MCV, MCH, and MCHC. The sample number in each group can be
set as 20-200. The sample is come from normal counting result of the instrument, without classifying whole
blood and pre-dilution mode.
Calibration is needed before testing, because X-B reference value is obtained through analyzing a large
number of random samples.
5.3.1 QC Setting
The QC parameters need to be set before X-B QC analysis.
(1)Click “Setting” in main menu, and select “QC Setting” in the left menu, open “X-B” interface, as Figure
5-3-1 shows:
Figure 5-3-1
Sample No. selected for each X-B point can be 20-200, the recommended number is 20.
Click ON under “X-B QC”, click “Apply”, “Saving succeeded” will pop up, click “OK”.
(2)Click “QC” in above menu, and select “X-B” in , as Figure 5-3-2 shows:
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Figure 5-3-2
Target and Deviation Limit Input:
Click the target and deviation limit to input them.
Target: Reference of different area may be different, so the sample number should reach certain number(more
than 500), the mean should be taken as target of X-B QC.
Deviation Limit: 3%-5% of target should be taken as deviation limit.
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Figure 5-3-3
(1)QC graph explanation:
The abscissa is the counting result number. The vertical axis is the result.
For each parameter, the three numbers on the left of the QC graph correspond to the three boundaries of QC
graph. From top to bottom, they represent the upper limit, target value and lower limit.
Upper limit: Control reference value + deviation limit
Target: Control reference value
Lower limit: Control reference value - deviation limit
For each parameter, the three numbers on the right of the QC graph represent Mean, SD, and CV%
respectively.
(2)Point of QC graph explanation
The points are QC results, they are connected by lines.
“Green Point” indicates the QC result is within the range. “Red Point” indicates the QC result is not within the
range.
(3)If the point is not within the range, conduct the following steps.
Check the target value and deviation limit.
Check whether the background test is normal.
Contact the manufacturer’s after sales service department if abnormity remains after calibration.
(4)QC data checking
The QC result can be checked through previous and next. Corresponding QC result will be displayed under the
parameter name. The position of the QC point and the total QC result number will be displayed in the form of
“Position/Total Number” at the lower left side of the interface.
5.3.4 QC List Review
Click QC list in Figure 5-3-3 to enter the X-B QC list review interface, as shown in Figure 5-3-4.
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Figure 5-3-4
(1)Delete: Click the QC data behind corresponding No., the line will turn blue, click “Delete”, as Figure 5-3-5
shows:
Figure 5-3-5
Click “Yes” in above figure, “Delete Succeed” will be displayed; the selected records will be deleted.
Figure 5-3-6
Click “Yes” in above figure, “Delete Succeed” will be displayed, all records will be deleted.
(3)Export: Click “Export” to enter Figure 5-3-7:
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Figure 5-3-7
Input the document name in the input box behind “Document Name”, and select the saving path, click “Save”.
Note:
The exported document will be saved in EXCEL form.
(4)Import: Click “Import”, the operator can import the QC counting result in the interface.
(5)LIS Transmission: Click “LIS Transmission”, the data will be transmitted to LIS, as the following figure
shows:
Figure 5-3-8
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Figure 6-1-1
6.2 Daily QC
QC analysis should be conducted every day before sample analyzing to ensure reliable result. Refer to
chapter 6 for operation.
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● Use clean EDTA-K2 anti freezing vacuum blood collecting tube, silicified glass/plastic tube and 20μL
silica glass capillary.
● The sample that needs WBC differential or platelet counting should be stored at room temperature. It
should be used within 8 hour after collection.
● If 5 part of PLT, MCV, or WBC is not needed, the sample can be stored at 2 ℃ - 8 ℃ in refrigerator
for 24 hours. The stored sample should be used after placing at room temperature for at least 30
minutes.
● After a period of time of still placing, the sample should be mixed again before use.
6.3.2 Add Diluent
(1)Click in shortcut area, the screen display as Figure 6-3-1, 6-3-2 shows:
Figure 6-3-1
Figure 6-3-2
(2)Take a clean tube or centrifuge tube, place it under the sampling probe, as Figure 6-3-3 shows:
Figure 6-3-3
(3)Press aspiration key, the diluent will be dispensed into the tube, the screen displays as Figure 6-3-4 shows:
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Figure 6-3-4
Ensure all the diluent(180μL)is added into the tube. Move the tube.
(4)And put 20 μL peripheral blood into the tube follow the tube wall. Mix them.
(5)Click “Cancel” in Figure 6-3-2, as Figure 6-3-5 shows:
Figure 6-3-5
Cancel diluent adding to finish preparation of diluted sample.
(6)If there are some samples needing to be diluted after the first one, the interface will be as Figure 6-3-2,
repeat the first process to finish other sample dilution. About 20 sample dilution can be done continuously.
● The operator can also use pipette to aspirate 180μL diluent and dispense it into the tube follow the
tube wall. And add 20 μL peripheral blood into the tube follow the tube wall. Mix them.
● When “pre-dilute” is selected, “Attention! Dilute sample in ratio of 1:10” will be prompted in sample
information.
● The diluent should be prepared in advance and protected from dust.
● After the mixing of peripheral blood and diluent, it should be placed for 3 minutes, and then remix
before use.
● The diluted sample should be used within 30 minutes.
● The sample should be re-mixed after placing for a period of time before use.
● The stability of the result on pre-dilution mode should be evaluated according to their own sample
number, sample collection method and technical level.
The pipeline should be rinsed when “Predilution” is switched into “Whole Blood”.
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Figure 6-4-1
(2)In “Mode”, blood sample mode is whole blood or predilution.
(3)The testing mode is “CBC” or “CBC+DIFF”.
“CBC” mode: conduct counting without WBC differential. The result includes 14 parameters and RBC, PLT
histogram.
“CBC+DIFF” mode: conduct counting and WBC differential. The result includes 24 parameters, scattergram,
histogram and 10 research parameters.
(4)Input the next sample No. in “Sample No.” input box.
(5)Select the reference range in the drop down list of “Reference Range”, default as “General”.
● The maximum digit of sample No. is 15. Not all figures number should be “0”, otherwise, the software
prompts invalid input.
● Number to enter “-”, but not enter “.”
6.4.2 Sample Information Editing
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Figure 6-4-2
6.4.2.1 Information Editing of Single Patient
Sample Information: refer to 3.2.1.1.
Patient Information: refer to 3.2.1.2.
6.4.2.2 Batch Patient Information Input
In batch patient information input, input one piece of patient information first and then copy the input patient
information, modify part of the information at last. Operations are same as the “3.2.2 Copy Patient
Information” and “3.2.1 Edit Patient Information”.
6.4.3 Sample Testing Steps
● There should be a space between probe tip and test tube bottom in the process of sample aspiration,
otherwise, the accuracy of the aspiration volume may be affected.
● Set the reference range of parameters in “Setting” interface, otherwise, incorrect alarm will be
prompted after testing.
● The default reference range is “Normal”. The alarm prompted after test is according to the reference
range of “Normal”.
Whole Blood Sample Testing:
Conduct whole blood sample testing according to the following steps in “Counting Interface” (As shown in
Figure 6-4-3):
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Figure 6-4-3
(1)Check the working mode is “Whole Blood Mode”. The green indicator in the middle of the front upper
cover is bright.
(2)Place the sample under the sampling probe. Make sure the probe can aspirate the mixed sample.
(3)Press “Counting” on instrument panel to start the sample testing. The sampling probe aspirate 20μL
sample.
(4)When the buzzer is heard, the operator can remove the sample. The sampling probe injects the sample into
the counting pool. The instrument will carry out test automatically.
(5)The sampling probe reset after testing, and prepare for next testing. The test result will be displayed in the
chart review of the computer. Meanwhile, the next sample number will plus one automatically.
(6)The instrument will save the test result after test.
(7)Conduct other sample testing according to this process.
(8)Click to enter into query interface, press “Print”, select “Current Record” or “Batch Print” to
print the report.
● In the process of testing, the interface can be switched to “Picture” “Research Parameter” to browse
the pictures or check the study parameters. But no operation can be conducted. The data will be saved
into the data review after test automatically.
● The result will be inaccurate if the temperature exceeds the normal working temperature range of the
instrument.
● If aperture is blocked during analysis, there will be ? behind the data, meanwhile “Aperture is clogged,
perform clog removal or rinsing aperture.” will be prompted. And the result will be inaccurate, thus test
should be conducted after “clog remove”.
6.4.4 Picture Check
Click “Picture” in Figure 6-4-3 to check the pictures of the test results, as Figure 6-4-4 shows:
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Figure 6-4-4
Histogram of RBC, PLT and WBC; histogram and scattergram of WBC 4 diff will be displayed.
6.4.5 Research Parameter Check
Click “Research Parameter/microscopic examination result” in Figure 6-4-4. Then the following figure will
pop up:
Figure 6-4-5
Print research parameters:
Select “Print research parameters” in “Setup”→“Print Setting ”. In case that “Input microscopic examination
result” is not selected, whether input the microscopy result in “Research parameter/microscopic examination
result” interface or not, click “ ” in above figure to print the research parameter.
In case that “Input microscopic examination result” is selected, when printing research parameter, if
microscopic examination result is not input, “Please input microscopic examination result” will be
prompted.
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(7)Click to enter into query interface, press “Print” or “Batch Print” to print the report.
● In the process of testing, the interfaces can be reviewed. But no operation can be conducted. The data
will be saved into the data review after test automatically.
● If block or air bubbles occurred, the instrument will set the relative parameter to be invalid. And
prompt the failure on the screen.
● The result will be inaccurate if the temperature exceeds the normal working temperature range of the
instrument.
6.5.1 Parameter Alarm
Parameter alarm includes the following three situations:
If the result is marked with “↑”or“↓”, that means the result exceeds the reference range.
If the result displayed as “***”, invalid result or range exceeding can be indicated. If WBC counting result is
smaller than 0.5*109/L or bigger than 999*109/L , or the pre-dilution result is smaller than 2*109/L or bigger
than 999*109/L, the system will not conduct WBC differential, the relevant parameter displays as “***”.
If the result is displayed with “?”, then the result is unreliable.
6.5.2 Differential or Abnormal Form Alarm
The instrument can prompt alarm according to the histogram and scattergram. As shown in table 6-5-1:
Table 6-5-1
(1)WBC abnormity alarm information
Information Meaning Judging Standard
WBC scattergram abnormal ? WBC scattergram abnormal DIFF channel scattergram abnormal
WBC increase Higher WBC counting WBC>18.0*10^9/L
WBC reduction Lower WBC counting WBC<2.5*10^9/L
Neutrophil increase Higher neutrophil counting NEUT#>11.0*10^9/L
Neutrophil reduction Lower neutrophil counting NEUT#<1.0*10^9/L
Lymphocyte increase Higher lymphocyte counting LYM#>4.0*10^9/L
Lymphocyte reduction Lower lymphocyte counting LYM#<0.8*10^9/L
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6.6 Sleeping
When it reaches the set sleep time, the instrument will enter into sleeping status automatically, and the status
information will be displayed in failure area. Users can press Count key to wake up the instrument, and
proceed with the instrument.
6.8 Shutdown
In order to ensure the stability and accurate test result of the instrument, shutdown is required for the
instrument after 24 hours continuous working. The operator must follow these steps to turn off the
instrument.
Shutdown includes mainframe shutdown and software exit.
6.8.1 Shutdown Mainframe
Figure 6-8-1
(2)Click “OK”, above figure will pop up. After shutdown liquid aspirating, “Shutdown instrument” will pop
up, the instrument will conduct pipe and counting pool rinsing and soaking. The following box will pop up
after the previous two steps:
Figure 6-8-2
(3)Switch to “O” on the right of the instrument to finish shutdown.
(4)Empty the waste solution container after shutdown.
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Click , or select “Menu”→“Exit System”, the following box will pop up:
Figure 6-8-3
Click “OK” to exit the software to finish the whole shutdown process.
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Click in main interface to enter into query interface, as Figure 7-1-1 shows:
Figure 7-1-1
The result displayed in the base is in testing sequence(The last result is at the first place). The default mode is
list mode.
If the screen cannot display all result, press “Next” or “Previous” to switch the pages. The position of the
current result and the total number of data base will be displayed in the form of “Pos/Total” at the bottom of
the interface.
Figure 7-1-2
Input the “Start No.” and “End No.” need to be queried in figure 7-1-2, click “OK”. The sample will be
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selected with .
● The input sample position should within the range of sample lib, otherwise, “Input range error, please
input again” will be prompted.
● If “Cancel Selection” is selected in drop-down list, the selection will be canceled.
7.2 Print
The sample results can be printed in sample query interface.
(1)Single sample Printing:
Click “Print” in Figure 7-1-1, if “Preview or not before printing” is selected in “Print Setting”, as the following
figure shows:
Figure 7-2-1
After printing the selected report, the current sample print status is , switch to the counting
interface, the print status on the printed report is “printed”.
(2)Bulk Print: Click “Bulk Print” in Figure 7-1-1, as Figure 7-2-2 shows:
Figure 7-2-2
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Select the test date of the report, and input the start and end sample No. If “Audited” is selected and “Preview
or not before printing” is selected, the report can be previewed, as the following figure shows:
Figure 7-2-3
The selected & audited samples will be printed. If “Audited” is not selected, all selected samples will be
printed.
After printing the selected report, the current sample print status is , switch to the counting
interface, the print status on the printed report is “printed”.
7.3 Query
The data can be queried through different condition. Click “Query” in figure 7-1-1, and select “Condition” in
Figure 7-3-1
Users can select different query conditions to query, including: sample No., barcode No., test time, test mode,
case No., name, gender, and department, deliver doctor, auditor and tester. The results can be queried
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Figure 7-3-2
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Figure 7-4-1
Click the No. in front of record(√), and click CV, as Figure 7-4-2 shows:
Figure 7-4-2
The repeatability of the results can be checked. If the any parameter of the selected sample is invalid, then the
repeatability of this parameter is invalid.
Click “Exit” in above figure to exit the interface.
7.4.2 Tendency Graph
In Figure 7-4-2, click “Tendency Graph” button, and Figure 7-4-3 is shown:
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Figure 7-4-3
Parameter setting in tendency graph:
Click “Setting” button in Figure 7-4-3, and the following figure pops up:
Figure 7-4-4
The user can set parameter items to be queried according to needs: in front of parameters means
parameters are selected. The user can click Button “SetTop”, “Upward”, “Downward”, and “SetBottom” to
adjust the positions for parameters in the tendency graph. After the setting, click “OK” to exit.
Deviation limit setting of tendency graph:
Click the input box under “Deviation Limit” on the right of Figure 7-4-3.The user can enter a deviation limit
corresponding to the parameter on the left. After editing, click “Save” button.
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Figure 7-5-1
Select the test date in the drop down list of “Test Date”, and input the start sample No. and end sample No.,
click “OK”, the auditor information of audited sample result will be displayed behind auditor.
7.6 Communication
Click “LIS” list review interface, and select proper records in list , the interface is as follow if
Input Range is selected.
Figure 7-6-1
Click “OK” after input. Data transmission can be conducted. The interface is as follow.
Figure 7-6-2
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Select “Sample Application” from pull-down menu “ ”, and the following figure pops up:
Figure 7-6-3
Enter start and end sample number, and click “OK” button. Patient information can be applied from LIS
system. The applied patient information is saved in the record of an edited sample to be tested or a tested
sample in the software.
7.7 Delete
Click “Delete” in Figure 7-1-1, and select the records need to be deleted in its drop-down list , as
Figure 7-7-1 shows:
Figure 7-7-1
Click “OK” in above figure to delete the records.
7.8 Export
The exported data can be saved.
Click “Export” in Figure 7-3-2, select the data needs to be exported in its drop-down list , as the
following figure shows:
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Figure 7-8-1
Input the file name in the input box behind “File Name”, and select the saving path, click “Save”, the
following box will pop up:
Figure 7-8-2
Indicates successful data export.
7.11 Recheck
If the user doubts the accuracy of a certain test result, select the record and click the right button of the mouse
from Figure 7-1-1. Then Figure 7-11-1 pops up:
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Figure 7-11-1
Click “Recheck” in Figure 7-11-1. The status changes from “Tested” to “Recheck”. Carry out tests according
to the routine testing method. The status displays “Testing ...”. After tests, the status turns into “Tested”,
namely, the recheck is finished.
In the process of recheck, the status of counting interface is the same with what of result query.
Figure 7-12-1
The sample result position and the total number in sample database will be displayed in the lower side of the
interface in “Pos/No.” form.
Current data can be saved, deleted or audited in this interface.
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Figure 7-13-1
In Figure 7-13-1, click “Review Compare”. Figure 7-13-2 pops up:
Figure 7-13-2
Figure 7-13-3
(1)Item Setting
From Figure 7-13-3, select parameter names to be displayed. And “ ” appears in check boxes. Click “OK”
button. After query, only results of selected parameters will be displayed.
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Figure 7-13-4
All the test results whose name including “1” corresponding to the test time can be queried.
Input name and case No. in Figure 7-13-2, and select “Exact Search”. Select a test time, and click “Query”.
Then the user can query the result corresponding to the test time, name and case number.
7.13.3 Tendency
After query according to the method above, click “Tendency”, and select a corresponding parameter from the
“Parameter” pull-down menu. Figure 7-13-5 pops up:
Figure 7-13-5
If “WBC” is selected, WBC tendency can be queried, the lower part displays the WBC value of each record.
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By default, “ ”is ticked in the compare list, users can check the corresponding graph in the tendency
interface. If only one item is ticked, select corresponding parameter in the tendency interface, and only one
point will display in the graph.
7.14 Backup
Click “Backup” in Figure 7-13-1, and then Figure 7-14-1 pops up:
Figure 7-14-1
There are 3 types of test data backup:
(1)If the radio button “Selected Record” is clicked, selected records will be backed up. “Selected Records” are
those with “ ” in the data list.
(2)If the radio button “All Records” is selected, all the records in the database will be backed up.
(3)If the radio button “Input Range” is selected, after selecting the test date range, records within the range will
be backed up.
After selection, click “OK”, and Figure 7-14-2 shows:
Figure 7-14-2
Select a backup path, enter the name of the file to be backed up, and click “Save”. Figure 7-14-3 is shown:
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Figure 7-14-3
After backup, the following figure pops up. Click “OK” to exit.
Figure 7-14-4
In addition, QC data backup, Calibration coefficients backup and set data backup can be selected, all the
backup contents will be recovered if necessary.
7.15 Restore
When the data saved in the database is damaged but the backup data is intact. Click “Restore” in Figure 7-13-1,
and then Figure 7-15-1 pops up:
Figure 7-15-1
Select the file path and file name, click “Open” and Figure 7-15-2 pops up:
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Figure 7-15-2
After data recovery, Figure 7-15-3 pops up:
Figure 7-15-3
Click “OK” to exit. Backup data are displayed in the database.
7.16 Help
Click “Help” in the menu to enter into Component Maintenance interface, and check the service condition of
the components, as following figure shows:
Figure 7-16-1
All the buttons should be dimmed. If any button is highlighted, the corresponding test item should be checked
or the corresponding component should be replaced. Please contact the after-sales service of the manufacturer
and ask the professionals for maintenance advice.
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Chapter8 Service
In order to ensure the normal running of the instrument, routine maintenance is required. The instrument will
prompt the user to conduct maintenance after testing a certain number of sample or a continuous working
period. The service menu in the instrument offers routine maintenance methods and failure solutions, but users
should make their own maintenance plan according to daily sample number, operating environment, running
time, etc. to reduce the impact of various factors and ensure the safe, stable and effective running of the
instrument.
● Don’t spill reagents, samples, waste liquid, etc over the mechanical or electrical parts of the
instrument, so as to avoid damage.
● While working, the operator should tack protective action, such as wearing protective gloves and
putting on labor clothes; otherwise, he/she may be infected when in contact with the contaminated area
and liquid. In case of contact with contaminated liquid, wash with water immediately and perform
sterilization.
● During cleaning and maintenance, pay attention to the parts holding liquid; the failure of them may
lead to danger.
● The instrument includes a laser device. The operator should pay attention to the related warning
labels during maintenance. Do not stare at the light beam directly or through optical devices.
● Improper maintenance may damage the instrument. The manual must be followed in maintenance.
● Contact the manufacturer's after-sales service department for unclear answers of the manual.
If the instrument is on a 24-hour run, users should conduct “Rinse Instrument” daily. Click the key
in the shortcut key area of the main interface to conduct the rinse operation. Or users can set the numbers of
automatic rinse intervals in “Setting”: 10-200. When a certain number of tests have been conducted, the
instrument will rinse itself automatically.
If the instrument is on for 24 hours, daily “WBC Pool Rinsing”, “RBC Pool Rinsing”, “DIFF Pool Rinsing”
operation should be conducted(service-maintenance-rinsing).
(2)Every week:
If normal shutdown operation is conducted every day, “Detergent Soaking”(WBC Pool, RBC Pool, DIFF
Pool)should be conducted every week.(service-maintenance).
(3)Every month:
Swab rinsing should be conducted each month if daily shutdown is conducted(Service-Maintenance-Rinsing).
For the first use of the 10mL detergent, take the 10mL detergent bottle out of the package, open the
cover, take out the rubber plug and pour 5mL -10mL detergent (about half a bottle of detergent) from
the 500mL detergent bottle to the 10mL detergent bottle. Then open the front door of the instrument,
put the 10mL detergent bottle in the reagent bottle slot which is in the middle of the counting unit (with
black cover). For the continuous use, when changing 500mL detergent, the 10mL detergent also needs to
be changed in accordance with the above steps.
8.1.2 Maintenance in Need
If the counting pool has been contaminated, conduct “Counting Pool Rinsing”.
When the instrument has not been used for 2 weeks or more, replace the reagent with distilled water, conduct
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“Rinse Pipeline” of “Maintenance”, and stop the distilled water, conduct “Empty Pipeline”, and place the
instrument at a clean place.
When the instrument prompt “clog” failure, press “Remove” to conduct manual remove or conduct “ Zap” and
“Backflush”.
Carry out priming if it has not been used for a long time.
The instrument will prompt “Soaking with Detergent” if the set counting number of software has been
conducted.
The reliable results can be obtained under the condition of normal working environment and state.
See the failure solution if other failure information is prompted.
Click “Service”(Figure 8-2-1) , and then click in front of System Version in the left tree to view the
version information of software, mainboard, collection board, temperature control board, laser driver board
and mechanism.
If “Mainboard” is selected, the version of software, hardware and update package will be displayed. See figure
8-2-2.
Figure 8-2-1
Version number of software and algorithm library is displayed.
Select Mainboard, as Figure 8-2-2 shows:
Figure 8-2-2
The version numbers shown in the figures above are just for reference, because the software version will
change as the system upgrades.
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Select “Instrument Information” in its drop down menu, as Figure 8-2-3 shows:
Figure 8-2-3
The information has been set before delivery. You can just view. Modification is not allowed.
8.2.2 Basic Status
Select “Basic Status” in Figure 8-2-2, the screen display as Figure 8-2-4:
Figure 8-2-4
Status explanation:
(1)Temperature: Real-time temperature of reaction pool, working environment and laser, and also the normal
range. When the room temperature is lower than 15℃ and is higher than the set lowest temperature or the
room temperature is higher than 30℃ and is lower than the set highest temperature, “the room temperature is
out of the normal range” will prompt at the bottom right of the software interface.
(2)Pressure: Pressure of pressure reducing valve and normal pressure range.
(3)Voltage: Display 55V, 5V, voltage of WBC aperture, RBC aperture and normal range.
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(4)Current: Display the normal range and power adjust valve of laser current.
Figure 8-3-1
Valve detection and voltage detection cannot be conducted at the same time.
Click “Exit” after test to exit the interface.
Click in front of “Maintain” in Figure 8-3-1, and select “Replace/Prime”, as Figure 8-4-1 shows:
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Figure 8-4-1
Reagent replacement and filling can be conducted. Users can conduct when installing the
instrument for the first time or after the reagents are used up. To replace a single reagent, see the following
operation:
(1)FDO Lyse Replacement:
Click “Replace FDO Lyse” when bubble exits in FDO Lyse pipeline, or FDO reagent is polluted, or FDO
reagent has been used up.
Figure 8-4-2
Figure 8-4-3
After replacing FDO Lyse, the following box will pop up:
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Figure 8-4-4
Click “OK” to finish the replacement of FDO Lyse.
Click “Cancel” in figure 8-4-2 to cancel FDO Lyse replacement.
(2)FDT Lyse Replacement:
Click “Replace FDT Lyse” when bubble exits in FDT Lyse pipeline, or FDT reagent is polluted, or FDT
reagent has been used up. The confirm interface will pop up. Click “OK”, pop up progress bar “Replacing
FDT Lyse. About 2 mins…”, After replacing FDT Lyse, “Operation finished” box will pop up, click “OK” to
finish the replacement.
Click “Cancel” to cancel FDT Lyse replacement.
(3)SLS-I Lyse Replacement:
Click “Replace SLS-I Lyse” when bubble exits in SLS-I Lyse pipeline, or SLS-I reagent is polluted, or SLS-I
reagent has been used up. The confirm interface will pop up. Click “OK”, pop up progress bar “Replacing
SLS-I Lyse About 2 mins…”, After replacing SLS-I Lyse, “Operation finished” box will pop up, click “OK”
to finish the replacement.
Click “Cancel” to cancel SLS-I Lyse replacement.
(4)Diluent Replacement:
Click “Replace Diluent” when bubble exits in Diluent pipeline, or Diluent is polluted, or Diluent has been used
up. The confirm interface will pop up. Click “OK”, pop up progress bar “Replacing Diluent About 7 mins…”,
After replacing Diluent, “Operation finished” box will pop up, click “OK” to finish the replacement.
Click “Cancel” to cancel Diluent replacement.
(5)Detergent Replacement:
Click “Replace Cleanser” when bubble exits in Detergent pipeline, or Detergent is polluted, or Detergent has
been used up. The confirm interface will pop up. Click “OK”. As shown in following figure:
Figure 8-4-5
Conduct Detergent replacement.
Click “Cancel” to cancel Detergent replacement.
(6)FDO Lyse Priming:
Click “Prime FDO Lyse” when FDO Lyse being emptied. The following box will pop up:
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Figure 8-4-6
Figure 8-4-7
Operation Completed box will pop up after FDO Lyse priming. Click “OK” to finish the priming of FDO
Lyse.
In the “fault information area”, clear the corresponding error message, the instrument automatically
conduct FDO Lyse priming when the software prompt FDO Lyse insufficiency.
(7)FDT Lyse Priming:
Click “Prime FDT Lyse” after FDT Lyse is emptied. And the operation should be conducted as the prompts.
Or: In the “fault information area”, clear the corresponding error message, the instrument automatically
conduct FDT Lyse priming when the software prompt FDT Lyse insufficiency.
(8)SLS-I Lyse Priming:
Click “Prime SLS-I Lyes” after SLS-I Lyse is emptied. And the operation should be conducted as the prompts.
Or: In the “fault information area”, clear the corresponding error message, the instrument automatically
conduct SLS-I Lyse priming when the software prompt SLS-I Lyse insufficiency.
(9)Diluent Priming:
Click “Prime Diluent” after Diluent is emptied. And the operation should be conducted as the prompts.
Or: In the “fault information area”, clear the corresponding error message, the instrument automatically
conduct Diluent priming when the software prompt Diluent insufficiency.
(10)Detergent Priming:
Click “Prime PK” after Detergent is emptied. And the operation should be conducted as the prompts.
Or: In the “fault information area”, clear the corresponding error message, the instrument automatically
conduct Detergent priming when the software prompt Detergent insufficiency.
8.4.2 Rinsing
Select “Rinse” in Figure 8-4-1, as Figure 8-4-8 shows:
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Figure 8-4-8
(1)Conduct WBC pool rinsing when the background test value of WBC or HGB parameter is abnormal. Click
Rinse WBC in Figure 8-4-8. As shown in Figure 8-4-9.
Figure 8-4-9
Figure 8-4-10
“Operation Complete” will pop up after WBC pool rinsing, click “OK” to finish the whole process.
Click “Cancel” in Figure 8-4-9 to cancel WBC pool rinsing.
(2)Conduct RBC pool rinsing when the background test value of RBC or PLT parameter is abnormal. Click
Rinse RBC in figure 8-4-8. Confirm box will pop up, click “OK”, progress bar will pop up. “Operation
Complete” will pop up after RBC pool rinsing, click “OK” to finish the whole process.
Click “Cancel” to cancel RBC pool rinsing in confirm box.
(3)Conduct DIFF pool rinsing when the WBC-diff parameter is abnormal. Click Rinse DIFF in Figure 8-4-8.
Confirm box will pop up, click “OK”, progress bar will pop up. “Operation Complete” will pop up after DIFF
pool rinsing, click “OK” to finish the whole process.
Click “Cancel” to cancel DIFF pool rinsing in confirm box.
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(4)In order to avoid sampling component contamination, swab rinsing should be conducted after one month’s
running.
Click “Rinse Swab” in Figure 8-4-8. The confirm box will pop up, click “OK”, as figure 8-4-11 shows:
Figure 8-4-11
Place the detergent used for probe rinsing under sampling probe and press sample aspiration key. Progress bar
will pop up. “Operation Complete” will pop up after swab rinsing, click “OK” to finish the whole process.
Click “Cancel” to cancel swab rinsing in confirm box.
(5)Bubble may exists in flow cell when magnified cell mass exists in scattergram and the background testing
value of WBC parameter is higher than normal value. “Sheath Pool Rinsing” should be conducted at this time.
The operation is as follow:
Click Rinse Sheath Flow Pool in Figure 8-4-8. Confirm box will pop up, click “OK”, progress bar will pop up.
“Operation Complete” will pop up after rinsing, click “OK” to finish the whole process.
Click “Cancel” to cancel sheath pool rinsing in confirm box.
(6)If bubble exists in sample aspiration pump or the test values are lower after reagent replacement. “Debubble
Sample Pump” should be conducted.
Click “Debubble Sample Pump” in Figure 8-4-8. Confirm box will pop up, click “OK”, progress bar will pop
up. “Operation Complete” will pop up after debubble, click “OK” to finish the whole process.
Click “Cancel” to cancel debubble in confirm box.
8.4.3 Maintenance
Click “Maintain” in Figure 8-4-8, as shown in Figure 8-4-12.
Figure 8-4-12
8.4.3.1 Emptying
In order to avoid liquid spill during pipeline maintenance, empty should be conducted first. Taken waste liquid
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Figure 8-4-13
Click “OK” in above figure to conduct empty WC. Progress bar will pop up. “Operation Complete” will pop
up after emptying, click “OK” to finish the whole process.
Click “Cancel” to cancel the emptying in confirm box.
The operation of “Empty PK”, “Empty WBC Pool”, “Empty RBC Pool”, “Empty DIFF Pool”, “Empty FDO
Lyse”, “Empty FDT Lyse”, “Empty SLS-I Lyse” and “Empty Diluent” is same as “Empty WC”.
(2)Click “Empty Pipeline” in Figure 8-4-12 when the instrument will not be used for 1-2 days. Place the
instrument at a clean position after pipeline emptying.
(3)Replace the reagent with distilled water when the instrument will not be used for more than 1 week. Click
“Package Clean Pipe” in Figure 8-4-12. Place the instrument at a clean position after above two steps.
8.4.3.2 Aperture
Aperture clog remove, zap and backflush should be conducted in order to clear the debris in aperture.
Click “Zap”, the following box will pop up:
Figure 8-4-14
Click “OK” in above figure, to clean the aperture through high-voltage direct current. The progress bar will
pop up meanwhile.
Click “Backflush”, the confirm box will pop up, click “OK” to flush it. The progress bar will pop up
meanwhile.
Together with zap, the RBC aperture clog can be removed.
Click “Remove Clog”, the confirm box will pop up, click “OK” to zap and flush the aperture. The progress bar
will pop up meanwhile.
8.4.3.3 Soaking with Detergent
In order to ensure the accuracy of the test result, detergent soaking of WBC pool, RBC pool and DIFF pool
assembly should be conducted in the following conditions:
Scattergram of test result is abnormal.
Aperture clog failure.
Detergent soaking prompted by the software.
(1)RBC Pool Soaking:
RBC pool soaking should be conducted every other week, the operation is as follow:
Click “RBC Pool” in Figure 8-4-12, as Figure 8-4-15 shows:
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Figure 8-4-15
Click “OK” in above figure, as Figure 8-4-16 shows:
Figure 8-4-16
The following box will pop up after soaking:
Figure 8-4-17
Click “Next” in Figure 8-4-17 to empty RBC, as the following figure shows:
Figure 8-4-18
Operation has been finished after emptying, as the following figure shows:
Figure 8-4-19
Click “OK” to finish the whole process.
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Figure 8-4-20
Click “OK” in above figure, as 8-4-21 shows:
Figure 8-4-21
Click “Next” , to empty WBC, as the following figure shows:
Figure 8-4-22
(3) DIFF Pool Soaking:
DIFF pool soaking should be conducted every other week, the operation is as follow:
Click “DIFF Pool” in Figure 8-4-12, as Figure 8-4-23 shows:
Figure 8-4-23
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Figure 8-4-24
The interface will pop up after soaking, as Figure 8-4-25 shows:
Figure 8-4-25
Click “Next”, as the following figure shows:
Figure 8-4-26
“Operation Complete” will pop up after emptying.
8.4.4 Reagent Registration
Click “Reagent Register” in Figure 8-4-12, the screen display as Figure 8-4-27 shows:
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Figure 8-4-27
(1)Input the barcode information manually:
Manual barcode information input can be conducted if the external barcode reader is not connected.
Click barcode input box in figure 8-4-27 to input the information according to the reagent package.
Click “OK” after input.
Left times: Scanning a barcode information for each, the remaining number will change accordingly (with the
reagent in proportion to the size of bottle).
(2)Scan barcode information:
Connect the barcode reader(connect the data wire of barcode reader with computer), click the input box behind
“Barcode” to turn into available status, scan the barcode outside the package box with barcode reader, screen
prompts “× × × register OK” and the barcode.
(3)Prompts for scanning failure:
The following information will be prompted if scanning failed:
Figure 8-4-28
Input the information after checking if above condition occur. Contact the manufacturer or his distributor for
continuous failure.
The following box will pop up if the barcode has been used:
Figure 8-4-29
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Do NOT stare at the scanning beam during the instrument running to avoid eye injury.
Sample Pump
Figure 8-5-1
1 5
2 4
3
1 SLS-I Syringe Pump 2 FDO Syringe Pump 3 FDT Syringe Pump 4 Test Pump 5 Diluent Pump
Figure 8-5-2
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Click “Log” in main interface, and select “Error Log” in its drop-down list , as Figure 8-6-1
shows:
Figure 8-6-1
The operator can also select “Operation Log” and “Failure Log” in its drop-down list for checking.
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Test the result in case of failure may cause inaccurate result. If alarm is prompt in the process of testing,
failure solution should be adopted first.
9.1 Overview
See the following relative failure solution if failure occur during working process.
Alarm information will be prompted in failure information area if failure occurs. Click the failure, Figure 9-1-1
will pop up:
Figure 9-1-1
Failure information name and help will be displayed.
Name of failure information will be displayed according to the order of the failure.
The failure solution can be checked in detail information.
Press “Clear” to clear the failure information. Click “Exit”.
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Alarm
Alarm Statement Solution
Code
1.Click Clear to clear this failure.
2. If this failure remains, please check whether the heater has
been damaged. replace it if it is damaged.
[E10002] WBC pool temperature is too low. 3.Please check whether the thermistor has been damaged. replace
it if it is damaged.
4.Please check whether the overheat protector has been damaged.
replace it if it is damaged.
1.Click Clear to clear this failure.
2.Please check the temperature sensor connection if this failure
WBC pool temperature sensor
[E10003] remains.
disconnecting
3.Please check whether the temperature sensor has been
damaged. replace it if it is damaged.
1.Click Clear to clear this failure.
[E00010] Test Motor Error 2.Please check whether test motor failure occur if this failure
remains.
1.Click Clear to clear this failure.
[E00016] Test Motor Sensor Error 2.Please check whether test motor sensor failure occur if this
failure remains.
1.Click Clear button to automatic clear failure.
[E00023] Sheath motor error
2.Check whether sheath motor failure occur.
1.Click Clear button to automatic clear failure.
[E00026] Sheath motor limit error
2.Check whether sheath motor failure occur.
1.Empty waste barrel or replace it with new waste barrel.
2.Please check the connection between sensor and mainframe if
[E00003] Waste Barrel Full
this failure remains.
3.Check the floater sensor.
1.Click Clear to clear this failure.
[E00013] Sampling Motor Error
2.Please check the sampling motor if this failure remains.
1.Click Clear to clear this failure.
[E00019] Sampling Motor Sensor Error
2.Please check the sampling motor sensor if this failure remains.
[E00001] Waste Bottle Full 1.Empty waste barrel or replace it with new waste barrel.
1.Click Clear to clear this failure.
[E00009] x-Axis Motor Error
2.Please check X axis motor if this failure remains.
1.Click Clear button to automatic clear failure.
[E00015] x-Axis Motor Sensor Error 2.If this failure still exist. check if failure occure on the sensor
of X-axis motor.
1.Click Clear to clear this failure.
[E00027] x-Axis Motor First Sensor Error
2.Please check X axis motor sensor 1 if this failure remains.
1.Click Clear to clear this failure.
[E00028] x-Axis Motor Second Sensor Error
2.Please check X axis motor sensor 2 if this failure remains.
1.Click Clear to clear this failure.
[E00029] x-Axis Motor Third Sensor Error
2.Please check X axis motor sensor 3 if this failure remains.
1.Click Clear to clear this failure.
[E00030] x-Axis Motor Fourth Sensor Error
2.Please check X axis motor sensor 4 if this failure remains.
1.Click Clear button to automatic clear failure.
x-Axis Motor Sensor Error
2.Please check X axis motor sensor if this failure remains.
1.Click Clear to clear this failure.
[E00008] Y-Axis Motor Error
2.Please check Y axis motor if his failure remains.
[E00020] Front door is opened 1.Click Clear to clear this failure automatically.
1.Please check whether there is diluent in the diluent bottle.
2.Replace a new diluent if there is no diluent in the bottle. Click
[E00004] Diluent Barrel Empty
Clear to prime diluent.
3.Check the floater switch if the diluent is sufficient.
1.Please check whether the diluent has been contaminated.
HGB background voltage exceeds
[E10016] 2.Click Clear if diluent has not been contaminated to clear this
range
failure.
1.Click Clear to clear this failure.
[E10011] 5V Voltage Exceeds Range
2.Please replace the circuit board if this failure unrestored.
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Alarm
Alarm Statement Solution
Code
1.Click Clear to clear this failure.
[E10013] 58V Voltage Exceeds Range
2.Please replace the circuit board if this failure remains.
1.Click Clear to clear this failure.
[E10015] Laser Current Exceeds Range
2.Please replace the circuit board if this failure remains.
1.Please check whether FDO Lyse is sufficient.
2.Please replace new reagent if there is no reagent and clear the
[E00006] FDO Lyse Empty
failure.
3.Check the floater switch if the reagent is sufficient.
1.Please check whether FDT Lyse is sufficient.
2.Please replace new reagent if there is no reagent and clear the
[E00007] FDT Lyse Empty
failure.
3.Check the floater switch if the reagent is sufficient.
1.Click Clear to clear this failure.
[E00012] Lyse Motor Error 2.Please check whether lyse agent motor failure occur if this
failure remains.
1.Click Clear to clear this failure.
[E00018] Lyse Motor Sensor Error 2.Please check whether lyse agent motor sensor failure occur if
this failure remains.
1.Please check whether there is diluent in the diluent bottle.
2.Replace a new diluent if there is no diluent in the bottle. Click
[E00002] Diluent Bottle Empty Clear to prime diluent.
3.Check the floater switch if the diluent is sufficient.
4.Check whether No.6 or 12 valve is working normally.
1.Click Clear to clear this failure.
2.Please check the air pump if failure remains.
[E10010] Pressure Error
3.Please check the air pipe connection.
4.Please adjust the pressure regulating valve.
1.Click Clear to clear this failure.
[E00014] Y Axis Motor Sensor Error
2.Check whether Y axis motor sensor failure occur.
1. Check control board chip TPIC6A595.
[E00032] Valve check error
2. Reset MU.
Data collect board communication
[E00033] 1. Check data collect board joint.
error.
[E30001] Control board reset error Change control board.
[E30002] Data colloct board reset error. Change data colloct board.
Temperature controller board reset
[E30003] Change temperature controller.
error.
[E30004] Sampler board reset error Change sampler board.
1. Please check waste liquid pump .
[E40001] Row of waste liquid fault error.
2. Please check waste liquid valve .
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10.1 Transportation
The transportation of the instrument should be in accordance with the contract stipulation. It should avoid
violent collision and should be protected from corrosive materials.
10.2 Storage
The packaged instrument should be kept in a well-ventilated room without corrosive gas, the temperature
should be -10℃~40℃, the relative humidity should be no more than 75%.
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message separator value, message type and message coding method and so on, it is each HL7 message’s first
message segment.
Information Example:
MSH|^~\&| XXX |1234567890|||20100419104618||ORU^R01|361|P^S|2.4|||||CHN|UNICODE<cr>
Serial HL7 Advised
Field Name Length Explanation Example
NO. Length
Include the first field separator after message
Field
1 1 1 segment, used for regulating other message |
Separator
field separator value
Coded Include discreteness separator, repeat
2 4 4 ^~\&
Character separator, ESC, sub-discreteness separator
Send Send terminal apply program
3 7 180 XXX
Program value: XXX
Instrument Sending terminal instrument, value:
4 10 180 1234567890
Code instrument code
Message created time (form
2011031014
7 Send Time 14 26 As YYYY[MM[DD[HH[MM[SS]]]]]) ,
4704
Take system time value
Message type, form as “information type”
Message
9 7 7 event type, value: ORU^R01(Sample) ORU^R01
Type
OUL^R21 (LJ/X, XB QC)
Message Message control ID is used for only mark
10 20 20 361
Control ID one message, value :PID
This field is used for decide on whether to
transact HL7 operation program’s (7th layer)
Transact ID
11 3 3 transact rule definition information. P^S
NO.
Value: P^ message type (Type Value:
S-sample, LJ-LJ /X barQC, XB-XB QC)
HL7 Version Agreements adopt HL7 version No. Value:
12 3 60 2.4
NO. 2.4
17 Nation Code 3 3 Nation code mark, refer to HL 7 2.4 CHN
ISO/IEC 10646-1-1993 International
18 Character Set 10 10 UTF-8
character standard value: UTF-8
PID:
PID–patient information: this information segment is optional, used for patient sample transmission, include
patient case history number, name, age, gender etc.
Message Example
PID||1234567890||| Wang San Qiang||| M<cr>
Serial HL7 Advice
Field Name Length Explanation Example
NO. Length
Case History Patient ID, here used for patient case history
2 20 20 1234567890
no. NO.
Wang San
5 Name 50 250 Patient name
Qiang
8 Gender 10 1 Gender, showed as character string M
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Enumeration Type
Data Item Value
test mode 0- CBC 1- CBC+DIFF
analysis mode 0 -Whole Blood 1-Predilute
0- normal
1- M
2- F
3- Child
4- baby
reference
5- custom 1
6- custom 2
7- custom 3
8- custom 4
9- custom 5
0- high
L-J/X QC level 1- medium
2- low
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(1)Patient Sample
<SB> MSH|^~\&| XXX ||||20110310150421||ORU^R01|8|P^S|2.4|||||CHN|UTF-8 <cr>
PID||1234567890|||Wang Sanqiang|||Male<cr>
PV1|||ABC^^235689||||Doctor Wang|Zhang San|Li Si<cr>
OBR||2|12345|1001^ Count Results||20110310112251|20110310112409|||||| |20110310 112251||||0|0 <cr>
OBX|1|IS|2001^MODE||0||||||F<cr>
OBX|2|IS|2002^MODE_EX||1||||||F<cr>
OBX|3|IS|2003^Ref||0||||||F<cr>
OBX|4|IS|2004^Age||17|age|||||F<cr>
OBX|5|ST|2005^Note||note position||||||F<cr>
OBX|6|NM|2007^V_WBC||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|7|NM|2008^V_BAS_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|8|NM|2009^V_NEU_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|9|NM|2010^V_EOS_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|10|NM|2011^V_LYM_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|11|NM|2012^V_MON_c||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|12|NM|2013^V_BAS_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|13|NM|2014^V_NEU_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|14|NM|2015^V_EOS_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|15|NM|2016^V_LYM_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|16|NM|2017^V_MON_p||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|17|NM|2018^V_RBC||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|18|NM|2019^V_HGB||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|19|NM|2020^V_MCV||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|20|NM|2021^V_MCH||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|21|NM|2022^V_MCHC||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|22|NM|2023^V_RDW_CV||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|23|NM|2024^V_RDW_SD||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|24|NM|2025^V_HCT||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|25|NM|2026^V_PLT||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|26|NM|2027^V_MPV||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|27|NM|2028^V_PDW||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|28|NM|2029^V_PCT||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|29|NM|2030^V_P_LCR||4.63|10*9/L|11.00-12.00|L|||F<cr>
OBX|30|ED|2101^RBC Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
OBX|31|ED|2102^PLT Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
OBX|32|ED|2103^WBC Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
OBX|33|ED|2034^DIFF Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
OBX|34|ED|2104^WBC Scattergram.BMP||……BMP binary system data change to BASE64
code……||||||F<cr>
<EB><CR>
(2)L-J/X QC
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<EB><CR>
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B.1.1 “TextBox”
Rectangular box which contain multiple lines of text. Type, color and width of frame, font attribute, text
alignment and font direction (vertical or horizontal) can be set. Use “Text” and “Frame” tools to set the
attribute of the object, as Figure B.1 shows:
Figure B.1
Text box object includes: text, variables, data fields or any combination of these. Font formatting will be
applied to all text included in text object.
TextBox Modification:
Click on the left of Report Edit Designer, click the left mouse after rectangular icon appears, as shown in
Figure B.2:
Figure B.2
Clipboard operation;
Word wrap;
“Cancel” button;
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“OK” button;
Note:
data included in the database includes patient information, sample test information, the corresponding
set of specific field will be detailed in the following chapter.
Figure B.3
Click “Select..” in Figure B.3, and click “OK”, the picture can be inserted into the report.
B.1.3 “Line”
The horizontal or vertical line can be inserted in the report. In separate statement of the report, straight-line
makes it easy to be read. The line thickness and color can be adjusted by using the drawing toolbar.
Click , drag the mouse in the current page, the cursor will turn into a pencil to draw a straight line. Click
the mouse to begin the line, release it when the line is finished. The line can be modified.
Line modification: select the corresponding button in “frame toolbar” to modify the line.
(1)“Standard” toolbar
(2)“Format” toolbar
(3)“Frame” toolbar
(4)“Alignment” toolbar
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Figure B.4
Select the paper size of current printer in the drop down list of paper size.
If the current printing support self-defined paper format, select “Self-defining”, and then input the width and
length of the paper format.
not all printer drive or printer support self-defining paper format (e.g. printer drive“HP LaserJet
6L”does not support 76*127mm size; printer drive“HP LaserJet 4L”does not support all self-defining
size).
B.2.2 Paper Source
Click “Paper Source” in Figure B.4, as Figure B.5 shows:
Figure B.5
Select the commonly used paper source.
B.2.3 Margins
Click “Margin” in Figure B.4, as Figure B.6 shows:
Figure B.6
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If the “Extend to the printer” option is selected, the page form of designer will not display the border area. All
regions of the page will be printed correctly. But the size is different in different printing.
If this option is canceled, and all margin set to be 0, then the margin will be automatically set to the selected
printer's maximum print area. When designed report switch from one printer to other printer (the printable area
of ink jet printer is smaller than that of stylus printer), this function very useful.
If the margin set to be non 0, margins will be reflected in a page from of the designer (marked with gray lines).
If you use a dot matrix printer, first preview whether the print content is within the print area (some stylus
printer will not print the content beyond printing scope, and other printer prompts the beyond print scope). In
this case, set the margins manually.
B.2.4 Other
Click “Margin” in Figure B.4, as Figure B.7 shows:
Figure B.7
Set the number of columns and column spacing according to the page width. If the “print to front page” option
is selected, it allows print the remaining area in the new page.
B.3 Users create their own report sheet
The report template we provided, list all data of patient test report and L-J QC report in detail. Open all
selected objects of the report before create report sheet. The report template is in software installation directory,
\ Print \ Sample: is patient sample report template; \ Print \ QC: is QC report template.
Concrete action : Open → select report → edit → Select All → New Report → Page Setup → Paste. In this
new report, the position, font and the letter of text can be modified.
B.3.1 Title
Set the sample test report and QC report in “System Setting”. For example: × × × hospital, the title is × × ×
hospital test report. The “Test Report” can be set hereby. It can be modified into “Blood test report”, “LJ
report”, etc. The title can be modified into static text.
B.3.2 Paper
Users also can modify the size of print paper. If the user use inkjet or laser printer and A4 paper, set paper A4.
If the user use stylus printer (such as: epson 300K, 1600K, etc.), and use 80 column printing paper, set the
paper to be self-defining. If a 80 column paper need to print three reports, set the paper to be 9.34(length). If a
80 paper need to print two reports, set the paper to be 14, paper width is 22. The default margin is 0.
B.3.3 Select the object need to be modified
Click the object need to be modified with mouse (points around the selected object will appear), press Shift,
more than one objects can be selected. Press Ctrl, and move the mouse meanwhile, then the mouse moved area
will be selected.
Modify the letter of the static text: select the text need to be modified, and double click the textbox, input the
modified letter in the corresponding box, and press “Enter”.
Modify the data field: If it is used to display certain data, only one textbox need to be added to appropriate
position, double-click the text box, input the data value, refer to the existing template for the value.
Move object: select the object (more than one can be selected), then press the four buttons around “Move” to
move the object, arrow keys on the keyboard can also be used.
Change size: select the object, press the up and down buttons of “high” or “width” to increase or decrease the
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height or width.
Change the font: Select the object, and then select the font size or bold, italic and so on.
Undo: error happened during modification, undo operation for one or more times, the report will return back to
the style before modification.
Save: press the “Save” button after all operation is completed. Note: If it is patient sample report, please store
in the software installation directory \ Print \ Sample folder; save quality control report into \ Print \ QC folder
of software installation directory
Use: open the system setting in data management software, select the report in print setting.
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If you need any technical support, please contact us according to the following address and telephone:
Register/Manufacturer: DIRUI INDUSTRIAL CO.,LTD.
Register/Manufacturer Address:
95 Yunhe Street, New & High Tech. Development Zone, Changchun, Jilin 130012, the People’s Republic of
China
Headquarter Address:
3333 Yiju Street, New & High Tech. Development Zone Changchun,Jilin 130103, the People’s Republic of
China
Factory Address:
95 Yunhe Street, New & High Tech. Development Zone Changchun,Jilin 130012, the People’s Republic of
China
Tel: 400 811 6695, 400 811 6605
Website: http://www.dirui.com.cn
E-mail: dirui@dirui.com.cn
For complaint: +86(431)81935326 85177245
Fax: +86(431)85173354
Domestic customer service hotline: 400 811 6695, 400 811 6605
Domestic fax: +86(431)85100405
Domestic customer service e-mail: service.ch@dirui.com.cn
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(4)PLT≤5.0%.
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