SERVICE MANUEL
© 2012-2015 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Tous droits réservés.
Pour ce Manuel de l'opérateur, la date d'émission est 2015-03.
Il est important pour la hôpital ou une organisation qui emploie cet équipement pour
mener à bien un plan de service / entretien raisonnable. La négligence de ce qui peut
entraîner une panne de machine ou nuire à la santé humaine.
ⅰ
REMARQUE
Cet équipement doit être utilisé par des professionnels cliniques qualifiés / formés.
garantie
CETTE GARANTIE EST EXCLUSIVE ET REMPLACE TOUTE AUTRE GARANTIE, EXPLICITE OU
IMPLICITE, Y COMPRIS LES GARANTIES DE QUALITÉ MARCHANDE OU D'ADAPTATION À UN
USAGE PARTICULIER.
exemptions
l'obligation de Mindray ou la responsabilité en vertu de la présente garantie ne comprend
pas de transport ou d'autres frais ou responsabilité pour les dommages directs, indirects ou
consécutifs ou retard résultant de l'utilisation abusive ou l'application du produit ou l'utilisation
de pièces ou accessoires non approuvés par Mindray ou des réparations par des personnes
autres que Mindray personnel autorisé.
Cette garantie ne doit pas étendre à:
Dysfonctionnement ou dommages causés par une mauvaise utilisation ou l'échec de l'homme.
Dysfonctionnement ou dommages causés par la force majeure tels que les incendies et les
séismes.
Dysfonctionnement de l'instrument ou d'une partie dont le numéro de série ne suffit pas lisible.
Service à la clientèle
Fabricant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Bâtiment Mindray, Keji 12 South Road, parc industriel de haute technologie,
Adresse: Nanshan,
Shenzhen 518057, République populaire de Chine
Site Internet: www.mindray.com
Adresse
électronique: service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680
EC-Représentant: Shanghai International Holding Corp. GmbH (Europe)
Tel: 0049-40-2513175
Fax: 0049-40-255726
II
Table des matières
1 Utilisation de ce manuel .............................................. ..................................................
................... 1-1
Vue d'ensemble ................................................. ..................................................
1.1 .................. 1-1
1.2 Qui devrait lire ce manuel ............................................. ..................................... 1-1
Utilisation de ce manuel ...............................................
1.3 .................................................. ..... 1-1
Conventions utilisées dans ce manuel .............................................
1.4 ................................. 1-2
Information sur la sécurité ................................................
1.5 .................................................. .... 1-2
1.6 Quand tu vois... ............................................ .................................................. ............. 1-4
1
Table of Contents
2
Table of Contents
3
Table of Contents
4
Table of Contents
8.4.5 Remove WBC bath and HGB Light Assembly ........................................... 8-24
8.4.6 Remove Preheating Assembly ..................................................................... 8-25
8.4.7 Remove Right Side Valve Assembly ........................................................... 8-26
8.4.8 Remove Liquid Detection Board PCBA ..................................................... 8-27
8.4.9 Remove Waste Pump ................................................................................... 8-28
8.4.10 Remove the Air Pump ................................................................................. 8-28
8.4.11 Remove Vacuum Chamber Assembly ......................................................... 8-29
8.4.12 Remove the Diluent Temperature Sensor .................................................... 8-30
8.4.13 Remove the Top Cover ................................................................................ 8-30
8.4.14 Remove the Aspiration Module ................................................................... 8-31
8.4.15 Remove the Motor Horizontal Photocoupler Assembly of Aspiration Module8-32
8.4.16 Replace Sample Probe ................................................................................. 8-32
8.4.17 Remove the Probe Wipe .............................................................................. 8-33
8.4.18 Remove the Aspiration Module Photocoupler in Vertical Direction ........... 8-34
8.4.19 Remove the Front Cover Assembly............................................................. 8-35
8.4.20 Remove Indicator PCBA ............................................................................. 8-37
8.4.21 Remove the Touch Screen Control Board ................................................... 8-38
8.4.22 Remove the Touch Screen Assembly .......................................................... 8-39
8.4.23 Remove the Touch Screen ........................................................................... 8-39
8.4.24 Remove the Micro-switch Assembly .......................................................... 8-40
8.4.25 Remove the Syringe .................................................................................... 8-41
8.4.26 Remove the Syringe Motor ......................................................................... 8-42
8.4.27 Remove the Syringe Motor Position Photocoupler Assembly .................... 8-43
8.4.28 Replace RBC/WBC Isolation Chamber Filter ............................................. 8-44
8.4.29 Replace Power Unit ..................................................................................... 8-44
8.4.30 Remove the Recorder .................................................................................. 8-45
5
Table of Contents
6
1Using This Manual
1.1 Overview
This chapter describes how to use the service manual. In this manual, the repair methods
of BC-20s/BC-30s are described in detail. Before servicing BC-20s/BC-30s, please carefully read
and understand the content in order to properly carry out maintenance procedures and
ensure the safety of service personnel.
This manual must be used in conjunction with the BC-20s/BC-30s Operator’s manual. It
does not contain information and procedures already covered in the Operator’s manual of
BC-20s/BC-30s.
Be sure to operate and service the analyzer strictly as instructed in this manual and the
operator’s manual.
Are able to use basic mechanical tools and understand the terminology;
1-1
Using This Manual
All illustrations in this manual are provided as examples only. They may not
necessarily reflect your analyzer setup or data displayed.
1-2
Using This Manual
All the samples, controls, calibrators, reagents, wastes and areas contacted by them
are potentially biohazardous. Wear proper personal protective equipment (e.g.
gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in
the laboratory.
If the main unit of the instrument leaks, the leaked liquid is potentially
biohazardous.
WARNING
It is important for the hospital or organization that employs this equipment to carry
out a reasonable service/maintenance plan. Neglect of this may result in machine
breakdown or injury of human health.
Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g. ethanol)
around the analyzer. Otherwise, the risk of explosion may exist.
Connect the analyzer to a socket having sole fuse and protective switch. Do not use
the same fuse and protective switch with other equipment (e.g. life supporting
equipment). Otherwise, the equipment failure, over current or impulse current that
occurs at the startup moment may lead to tripping.
To prevent personal injury during the maintenance, keep your clothes, hairs and
hands from the moving parts, such as the sample probe.
Possible mechanical movement of the warned position may lead to personal injury
during normal operation, removal, maintenance and verification.
1-3
Using This Manual
government regulations.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if
necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off
with plenty of water and immediately go see a doctor.
CAUTION
Improper maintenance may damage the analyzer. Maintain the analyzer strictly as
instructed by the service manual and inspect the analyzer carefully after the maintenance.
For problems not mentioned in the service manual, contact Mindray customer
service department for maintenance advice.
NOTE
The operator is required to follow the instructions below this symbol.
The instructions will emphasize important information or information that
requires particular attention of the operator.
Symbol Meaning
The operator is required to follow the instructions below
this symbol. Failure to do so may place the operator at a
potential risk of biohazard.
The operator is required to follow the instructions below
WARNING this symbol. Failure to do so may cause personal injury.
1-4
Using This Manual
CAUTION
Ensure the labels are in good condition and not damaged while servicing the analyzer.
CAUTION, CONSULT
ACCOMPANYING DOCUMENTS.
Note: It is recommended that the reader
refers to the accompanying documents for
important safety information.
BIOLOGICAL RISK
USB port
Network interface
ALTERNATING CURRENT
Batch code
1-5
Using This Manual
USE BY (YYYY-MM-DD)
Serial number
DATE OF MANUFACTURE
Pricking danger
Manufacturer
TEMPERATURE LIMITATION
1-6
2 Product Specifications
2.1 Product Name
Name: Auto Hematology Analyzer
BC-20s Appearance
BC-30s Appearance
2-1
2.2 Physical Specifications
Height
Depth
Width
Parameter Value
Voltage (100V-240V~) ±10%
Input Power ≤300VA
Frequency 50/60±1Hz
2-2
Product Specifications
2.5.2 Throughput
The throughput of BC-20s in OV-WB/OV-PD is no less than 40 samples/hour;
The throughput of BC-30s in OV-WB/OV-PD is no less than 70 samples/h;
Table 1 Parameters
Name Abbreviation
White Blood Cell count WBC
Lymphocyte number Lymph#
Mid-sized Cell number Mid#
Granulocyte number Gran#
Lymphocyte percentage Lymph%
Mid-sized Cell percentage Mid%
2-3
Product Specifications
Table 2 Histograms
2.7.2 Carryover
Carryover refers to the transfer of blood cells from high concentration sample to low
concentration sample.
Verification method:
Prepare a high concentration sample (centrifuged high value control or special high
value linearity control) which is within the range specified in Table 2-6, mix and then test it
2-4
Product Specifications
consecutively for 3 times, and the test results are i1, i2, and i3; prepare a low concentration
sample (diluted low value control, dilution ratio: 1:10) which is within the range specified in
Table 2-6, test it consecutively for 3 times, and the test results are j1, j2, and j3. Calculate
the carryover according to the following equation, and the result shall meet the requirements
in Table 2-5.
Parameter Carryover
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.6%
PLT ≤1.0%
2.7.3 Repeatability
Test a sample which meets repeatability requirement on the analyzer consecutively for 10 times,
calculate the CV(%) and absolute deviation (d) of each parameter, and the results shall meet the
requirements in the following table.
In the equation:
s x
----standard deviation of sample test results;
----mean value of sample test results;
x i
----actual test result of the sample;
d
----absolute deviation of the sample test results.
Table 2-7 Whole Blood Repeatability Requirements
2-5
Product Specifications
2.7.4 Linearity
Linearity was determined by running diluted samples. Samples of different concentrations were
tested in both whole blood and predilute modes; the slope and intercept were calculated per the linear
regression equation, and then the deviation between the theoretical value and test result was obtained,
which shall meet the requirements in the following table.
2-6
Product Specifications
WBC 0.00×109/L~999.99×109/L
RBC 0.00×1012/L~18.00×1012/L
HGB 0 g/L~300g/L
PLT 0×109/L~9999×109/L
HCT 0%~80%
Figures, pictures and drawings in this manual are prepared based on BC-30s, of which
the structure is basically the same as that of BC-20s.
The analyzer is heavy. Do not try to carry it by oneself, or serious injury may be
caused. It requires at least two persons to transport the analyzer. Use necessary tools if
possible.
2-7
Product Specifications
2-8
Product Specifications
CAUTION
Once you turn on/off the analyzer, do not operate the power switch again in 10 seconds,
or it may cause damage to the analyzer.
2-9
Product Specifications
Store and use the reagents as instructed by instructions for use of the reagents.
When you have changed the diluent, lyses, run a background to see if the results meet
the requirement.
Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.
After installing a new container of reagent, keep it still for a while before use.
2.11.1 Reagents
M-30PD diluent
2-10
Product Specifications
M-30PCFL lyse breaks down the red cells and achieve WBC 3-part differential.
Probe Cleanser
Probe Cleanser is used for the regular cleaning of the analyzer
2-11
3 System Principles
3.1 Introduction
The analyzer uses the electrical impedance method to determine the count and size
distribution of RBC, WBC and PLT; and uses the colorimetric method to determine HGB.
Based on the above data, the analyzer calculates other parameters.
The scheduling control and information processing module coordinates and regulates
other functional modules to work by defined process and requirements, so as to ensure the
completing of sample measurement, the ultimate task of the analyzer.
3-1
System Principles
3.3 Aspiration
If you are to analyze a whole blood sample, present the sample to the analyzer
directly, and the analyzer will aspirate 9 μL of the whole blood sample.
If you are to analyze a capillary blood sample under the pre-dilute mode, you should first
manually dilute the sample (20 μL capillary sample needs to be diluted by 0.7 mL of diluent
to form a 1:36 dilution), and then present the pre-diluted sample to the analyzer, which will
aspirate 198uL of the sample.
3.4 Dilution
Usually in blood samples, the cells are too close to each other to be identified or
counted. For this reason, the diluent is used to separate the cells so that they draw through
the aperture one at a time as well as to create a conductive environment for cell counting.
Moreover, red blood cells usually outnumber white blood cells by 1,000 times. Because red
blood cells usually have no nucleus, they are eliminated when the lyse breaks down their
cell walls. For this reason, lyse need to be added to the sample to eliminate the red cells
before the WBC counting. The analyzer provides whole blood mode and predilute mode for
the analysis of different sample types.
The WBCs are counted by the impedance method. The analyzer aspirates certain volume
of sample, dilutes it with certain volume of conductive solution, and delivers the dilution to
the metering unit. The metering unit has a little opening which is called "aperture". A pair of
electrodes is positioned on both sides of the aperture, and creates a constant-current supply.
As cells are poor conductors, when each particle in the diluted sample passes through the
aperture under the constant negative pressure, a transitory change in the direct-current
resistance between the electrodes is produced. The change in turn produces a measurable
electrical pulse which is proportional to the particle size. And when the particles pass the
aperture in succession, a series of pulses are produced between the electrodes. The number
of pulses generated indicates the number of particles passed through the aperture; and the
amplitude of each pulse is proportional to the volume of each particle.
Each pulse is amplified and compared to the internal reference voltage channel, which
only accepts the pulses of certain amplitude. All the collected pulses are thus classified based
on the reference voltage ranges of different channels, and the number of the pluses in the
WBC channel indicates the number of the WBC particles. The cell size distribution width is
represented by the number of particles falling in each channel.
3-2
System Principles
In the formula, WBC′ is corrected WBC count result; WBC is the WBC count provided by
the analyzer; and NRBC indicates the number of NRBCs found when every 100 WBCs are
counted.
3-DIFF of WBC
Lyses and diluents change the sizes of each type of WBCs in various ways and at
different time. The WBCs are thus separated into 3 parts (from the largest size to the
smallest): lymphocytes, mid-sized cells (including monocytes, eosinophils, and basophils)
and granulocytes.
The analyzer then calculate the lymphocyte percentage (Lym%), mid-sized cell
percentage (Mid%) and granulocyte percentage (Gran%) (All presented in %) based on the
WBC histograms and in accordance with below formulae:
3-3
System Principles
In the formulae: PL indicates the number of cells falling in the lymphocyte region, PM
the number of cells falling in the mid-sized cell region, and PG the number of cells falling in
the granulocyte region. All three parameters are presented in 109/L.
When the three percentages are obtained, the analyzer automatically proceeds to calculate
the lymphocyte number (Lym#), mid-sized cell number (Mid#) and granulocyte number
(Gran#) by below formulae , all parameters expressed in 109/L.
Besides the count results, the analyzer also provides a WBC histogram which shows the
WBC size distribution, with the x-axis representing the cell size (in fL) and the Y-axis
representing relative cell number (in 109/L)(as shown below). The WBC histogram of a
normal blood sample (lysed and processed) should show display 3 clear parts: the small cell
(about 20~70fl) region represents the LYM group (lymphocytes); the mid-sized cell (about
70~150fl) region represents the Mid group (including monocytes, eosinophils and
basophiles); and the large cell (over 150fl) region represents the Gran group (granulocytes).
3-4
System Principles
After each analysis cycle, you can either check the WBC histogram in the analysis result area on
the "Sample Analysis" screen or review the histogram on the "Review" screen.
Blank Photocurrent
HGB(g/L) Constant Ln
Sample Photocurrent
3-5
System Principles
RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes
passing through the aperture.
The hematocrit (HCT, %), mean corpuscular hemoglobin (MCH, pg.) and mean corpuscular
hemoglobin concentration (MCHC, g/L) are calculated as follows:
Where RBC is expressed in 1012/L, MCV is expressed in fL and HGB is expressed in g/L.
3-6
System Principles
RDW-CV
Red Blood Cell Distribution Width - Coefficient of Variation (RDW-CV) is derived based on
RBC histogram. It is expressed in %, and indicates the variation level of RBC size distribution.
RDW-SD
Red blood cells distribution width - standard deviation (RDW-SD, in fL) measures the width
of the 20% level (with the peak taken as 100%) on the RBC histogram, as shown in Figure 3-3.
Figure 3-3
Besides the count results, the analyzer also provides a RBC histogram which shows the
RBC size distribution, with the x-axis representing the cell size (in fL) and the Y-axis
representing relative cell number (in 1012/L)(as shown below). With a normal blood
samples, the RBCs mostly fall in the region of 70~120fl.
After each analysis cycle, you can either check the RBC histogram in the analysis result
area on the "Sample Analysis" screen or review the histogram on the "Review" screen.
PLT (109/ L) is measured directly by counting the platelets passing through the
aperture.
Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL).
PDW
3-7
System Principles
Platelet distribution width (PDW) is derived from the platelet histogram, and is reported as
10 geometric standard deviation (10 GSD).
PCT
The analyzer calculates the number of platelets larger than 12fl in size based on
the platelet histogram and then derives the large platelet ratio (%).
Platelet Histogram
Besides the count results, the analyzer also provides a PLT histogram which shows the
PLT size distribution, As shown in below, most PLTs of a normal blood sample should fall
into the 0~20fl region. with the x-axis representing the cell size (in fL) and the Y-axis
representing relative cell number (in 109/L).
After each analysis cycle, you can either check the PLT histogram in the analysis result
area on the "Sample Analysis" screen or review the histogram on the "Review" screen.
3.7 Wash
After each analysis cycle, each element of the analyzer is washed:
3.8 Troubleshooting
3.8.1 Flags
The analyzer provides 26 algorithm flags. Refer to below table for flag meanings
and conditions.
3-8
System Principles
3-9
System Principles
agglutination and
diamorphologic histogram.
HGB results may be
MCHC > 380 g/L
HGB abnormal or interference
or interfering parameters of HGB
Abn./Interfere? may exist (for example,
exceed allowable ranges
high WBC count)
Microcytosis Small MCV MCV < 70fL
Macrocytosis Large MCV MCV > 110fL
Anemia Anemia HGB < 90g/L
Erythrocytosis High RBC count RBC > 6.5×10^12/L
High number of small
PLT Histogram Ps PLCR < 15%
platelets.
High number of large
PLT Histogram P1 PLCR > 50%
platelets.
Possible presence of
The boundary of the PLT/RBC is
PLT Histogram microcytosis, RBC debris,
too confusing for the system to
PLT Pm large platelet and platelet
define.
coagulation.
Platelet
distribution Abnormal PLT histogram PLT histogram Pm flag is reported
abnormal
Thrombopenia Low PLT count PLT < 60×10^9/L
Thrombocytosis High PLT count PLT > 600×10^9/L
Abnormal WBC size R/?* : WBC and infected WBC differential parameters.
Different WBC parameters may be marked by R or *
distribution
depending on different situations.
Leucopenia /
Leucocytosis /
Granulopenia /
WBC
Granulocytosis /
lymphopenia /
Lymphocytosis /
High mid-sized cell /
number
Pancytopenia /
Abnormal RBC size Infected parameters marked by R/? : RBC, HCT, RDW-CV,
RBC
distribution RDW-SD etc. Different RBC parameters may be marked
3-10
System Principles
3-11
4 Software and Interface
4.1. Login
NOTE
Password is case sensitive.
Level
When you log in at service access level, the analyzer will automatically run a check matching the
backup data on the board card with the data in the SD card. If the board card or SD card has been
replaced before, or the analyzer detects configuration change before abnormal shutdown, you will be
prompted to restore the system or back up data.
Tap "OK" to enter the screen and follow the instructions to enter below screen and follow the
instruction to backup and restore the data:
4-1
Software and Interface
1) When the SD card has been replaced, follow the instruction and "restore" the important
parameters to the new SD card.
2) When the main control board has been replaced, follow the instruction and "backup" the data
to the new main control board,
NOTE
Always perform the shutdown procedure before replacing the SD card or main control
board, so the data will be automatically backed up.
4-2
Software and Interface
4.2 Review
When the mean value of the selected parameter results are calculated, then the ordinates
corresponding to the mean value point, the upper limit point and the lower limit point are Mean,
Mean + Mean * 10%, and Mean – Mean * 10%.
Calculate the upper or lower limit of certain parameter result by "Mean+Deviation". If a result
does not confirms to the acceptable data format, round it up to get the corresponding ordinates.
Tap the "Setup" button on the trend graph screen to enter the parameter limit setup screen (as
shown below):
4-3
Software and Interface
4.3 Calibration
multiply with the analysis results to output the final results. When running a calibrator, the analysis
results after being adjusted by the factor should be as close to its assigned targets. Thus the calibrator
factor is derived by below formula:
Calibration with fresh blood includes two modes of "WB" and "PD", which use different fluidic
sequences. Perform calibration for each of the two modes separately.
Besides the calibration factor of the manufacturer, the factor of the users is also used to calculate
the results. For example ,under the CBC+DIFF mode, the final analysis results output by the analyzer
are calculated as follow:
Only the 5 traceable parameters are used in the calibration including: WBC, RBC, HGB, MCV
and PLT.
4-4
Software and Interface
CAUTION
When you perform calibration at the service access level, the calibration factors of
manufacturer will be modified, and the calibration factors of user will change to 100.00%.
Before calibration, make sure to set up the lot numbers, expiration dates, analysis modes and the
target values for the calibrators.
The calibration factors should fall into the range of [75%, 125%].
CAUTION
Never use expired calibrators.
4-5
Software and Interface
NOTE
If the calibrated factors or CVs are out of allowable range, they will be displayed in red, and
the values cannot be saved.
When you enter the "Sample Probe Debug" screen, press the "Initialize" button first. The
sample probe debugging will only start after initialization. For details, please refer to Section
10.2 Adjustment of Mechanical Positions.
4-6
Software and Interface
As you can see from the figure above, four values are displayed on this screen, namely Total
difference, New difference, Machine measurement value and Meter measurement value. Machine
measurement value refers to the temperature displayed on the "Temp & Pressure screen", while the
"Meter measurement" displays the temperature measured by thermograph. "Total difference" and
"New difference" are calculated values. However, the real measured value, which is measured by the
temperature sensor, is also used but not displayed.
Enter the "Meter measurement" value and tap "Calculate new diff." to get the new
difference. New difference = Meter measurement – Real measurement
Tap "Save" to assign the new difference value to the "Total difference", e.g., Total
difference = New difference.
Machine measurement = Real measurement + Total difference
4-7
Software and Interface
CAUTION
The function only supports the calibration with calibrators.
4-8
Software and Interface
NOTE
As the gain settings affect the validity of analysis results, be careful when you adjust them.
4-9
Software and Interface
4.8 Performance
Enter the "Background count" screen and press the [Aspirate] key to start background count.
You do not need to run actual samples. The background is acceptable only when all the result boxes
display "pass" on the background count screen.
4-10
Software and Interface
4.8.2 Reproducibility
Test a sample which meets reproducibility requirement on the analyzer for 10 times, and
calculate the CV (%) and absolute deviation (d) of each parameter, and the results shall meet the
reproducibility requirements.
NOTE
End users usually use normal controls to calculate the reproducibility.
4-11
Software and Interface
4.8.3 Carryover
Make sure the analyzer is working properly and steadily. Run a high value sample consecutively
for 3 times and then run a low value sample consecutively for 3 times. Calculate the carryover per
below formula:
Carryover(%) First low - level sample result-Third low - level sample result100%
Third high - level sample result-Third low - level sample result
4-12
Software and Interface
NOTE
When you change the language setting, the new language will only become effective after
restart.
NOTE
The USB should have been formatted to FAT32 before you copy and paste the "update"
directory to it.
4-13
Software and Interface
Recommended USB models: Kingston 8/16G, SanDisk 8/16G and Maxell 4/8G.
Make sure there is enough free space (at least 4G) on the USB.
Unzip the file named "update.tar.gz", and then copy the "update" directory in the unzipped file to
the root directory of the formatted USB.
NOTE
The USB should have been formatted to FAT32 before you copy and paste the "update"
directory to it.
When the USB is ready, it should have an "update" folder under the root directory, and the
"update" folder further contains two sub-folders named "step1" and "step2".
Update
Insert the USB to one of the USB ports on the analyzer, and perform update following either of
the below methods:
4-14
Software and Interface
If the update guide and the operation system also need to be updated, the system will
prompt you to restart the analyzer between step 1 and step 2; if only the software module
need to be updated, the update will start from step 2 directly.
CAUTION
Do not pull the USB or disconnect power during the update; otherwise the analyzer may not
start.
NOTE
The update usually takes about 10 minutes but depends on the number of modules to be
updated. Do not leave the analyzer as the process requires user operation.
4-15
Software and Interface
Running with error Flickering red Running, but there is/are error(s)
Error and not running Static red There is/are error(s), and the
analyzer is not running
No error, but fluidic actions are not Static yellow Startup initialization or standby,
allowed not involving fluidic actions
4.12 Buzzer
When there is any error, the buzzer gives out an alarm sound. Tap the touch screen to silent the
buzzer; or when the errors are removed the alarm sound will stop automatically. The buzzer also
sounds in other ways indicating different system status.
Table 4-2 Buzzer sounds
When... The buzzer Remarks
sounds
On the analysis related screens A long beep When there are dialog boxes
(e.g. screens of sample analysis, popped out prompting further
QC, reproducibility, carryover, action, the buzzer may not
background, aging or gain sound.
calibration), press the [Aspiration]
key to start analysis
4-16
Software and Interface
The analyzer screen becomes Silent When there is/are error(s) during
black, and prompts "Please turn off shut down process, the buzzer
the power of the analyzer!" stops when the analyzer screen
becomes black.
4-17
5 Data Transmission
5.1 LIS Connection
Communication Setup (Menu > Setup > System Setup > Communication)
You can set the following on the "Communication" screen:
Network communication
Transmission Mode
Network Types
NETGEAR: WNA3100M;EDUP:EP-
N8508GS.
When using a wired network, you only need to set up the protocol; when using a wireless
network, insert the wireless network card, and tap the button on the right of the "Network Type" pull
5-1
Data Transmission
down list. Then set the Wi-Fi on the popped-out dialog box.
Protocol Setup
IP Address:
Setup the IP for the analyzer; 10.0.0.2 by default
Subnet mask:
Subnet mask for the analyzer network; generally being 255.255.255.0
Default gateway:
Gateway IP
Mac Address:
The Mac address of the analyzer is fixed by manufacturer and cannot be changed.
Communication protocol:
Tap the pull down list to select a suitable communication protocol.
NOTE
The IP address for the analyzer is assigned statically. Ask your network administrator for the
5-2
Data Transmission
If the communication involves more than one subnet, ask your network administrator for
correct subnet mask and gateway.
Ensure the wireless network card is properly inserted before setting up the Wi-Fi network.
Network Types
Chip model: FTDI-FT232.
Protocol Setup
Baud rate: the transmission rate for serial communication; 19200 by default;
Check Bit: parity bit, empty by default;
Data Bit: 8 by default;
Stop Bit: 1 by default;
Comm Protocol: support HL7, 8ID and 10ID serial communication protocols
5-3
Data Transmission
Auto Retransmit
The option can only be activated when the "ACK Synchronous Transmission" check box is
checked. When "Auto Retransmit" is selected, if ACK is not received in specified time, the software
will automatically re-send the data.
Auto Communicate
When the option is selected, software will automatically send the sample information and
analysis results to the LIS.
When the option is selected, the histograms will be sent to LIS as printed data with white
background.
Histogram transmitted as
Select the histogram transmission method from the pull down list:
Not to be transmitted
Histograms will not be transmitted when this option is selected.
Bitmap
When this option is selected, the histograms will be transmitted in the format of bitmap to LIS.
Data
When this option is selected, histograms will be transmitted to LIS as digital data in Mindray-
specified format and only can be reviewed with Mindray data management software
5-4
Data Transmission
As seen on above figure, the IP address and protocol should be set as the same as those of the
analyzer. The port is fixed to be 5100.
5-5
Data Transmission
Set the analyzer as server, and LIS and the data management software as the client. The
connection must be initialized from the client.
Check whether the network cable is properly connected; and whether the network physical
connection is correct.
Communication setup
Check whether the network settings (including the communication setup for both analyzer and
LIS) are correct.
Network firewall
To check whether there is a network firewall, open the network connection licenses for LIS, data
management software and the 5100 port.
5-6
6 Fluidics
6.1 Introduction to Fluidic Parts
Appearance:
2-way valve 3-way valve
Spring
pole
Function:
2-way valve: to build up or cut off a passage. When power off, the passage from the inlet of the
valve to outlet is cut off; when power on, the passage is built up.
3-way valve: to switch among passages. When power off, the public end and the NO (normally
open) end are connected; when power on, the public end and the N.O.(normally open) end are
connected.
Note: the operating voltage of Mindray valves is 12V, and maximal bearable pressure is
200KPa. The internal movement of the valves is driven by electromagnet and the
restoration is driven by the spring, so it is recommended not put the valves power-on for
too long. When the electromagnet valve is working, the spring pole will lower down, and
it will rise to the initial position when power off. You can touch the spring pole and feel
the descending or ascending, in order to determine whether it is in action.
6-1
Fluidics
Function: same as of the Mindray valves. Compared with the 2-way valve, this valve bears
higher pressure and has a pump with smaller action volume; so it may adapts to more
strict flow control and greater temperature and pressure changes in
Note: the maximal bearable pressure of the LVM fluidic valve is 200KPa, and the CV of the
flow is about 0.03. The SV02 in the fluidic charts is LVM fluidic valve.
Function: the linkage syringe device, driven by a motor and a unit of driving assembly,
consists of two syringes: one with a high dispensing volume, the other with a low
dispensing volume.
Specificati
Name Function
on
6-2
Fluidics
High volume RBC bathes, dispense liquid to the probe wipes, and
Full range: 10ml
syringe supports the cleaning of the interior and exterior of
sample probe as well as the baths.
Preheating bath
Appearance:
Function: dispense diluent and ensure the reaction temperature in the WBC bath.
6-3
Fluidics
Appearance:
Function: to empty probe wipes, WBC bath and RBC bath; empty the vacuum
chamber and build vacuum pressure in the chamber
Appearance:
6-4
Fluidics
Appearance: N/A
Function: provides a rigid, blood corrosion-resistant cavity for aspiration and dispensing of
sample and probe cleanser.
6-5
Fluidics
Appearance:
Function: provide a cavity where the interior and exterior walls of open-vial probe or piercing
probe can be cleaned by liquid flow; and the waste thus produced is also collected here.
6.1.9 Baths
WBC bath: consists of front bath, back bath and an aperture. It is where the WBC
sample is mixed for analysis; supports the measurement of HGB and WBC.
RBC bath: consists of front bath, back bath and an aperture. It is where the RBC
sample is mixed for analysis; supports the measurement of RBC/PLT.
Vacuum chamber: where a stable vacuum is built and stored to support WBC and RBC
count (impedance method); and the front and back baths as well as the sample probe
wipe are cleaned.
6.1.10 Filters
Isolation chamber filters: filter the impurities and debris from the WBC bath.
6-6
Fluidics
1) The sample probe aspirates 9uL of sample blood and ascends. In the meanwhile, the exterior
wall of the sample probe is cleaned.
2) Dispense the initial volume and 9uL of sample to the WBC bath, where they are well mixed
to prepare the diluted sample for WBC and HGB measurement.
3) The sample probe ascends. In the meanwhile, its exterior wall is cleaned. Where the sample
probe ascends to the probe wipe, it dispenses some of the diluent in it to clean its interior wall.
4) The sample probe whirls descending to the RBC bath, and dispenses initial volume to the
bath.
5) The sample probe whirls descending to the WBC to aspirate 23.1ul of diluted sample and then
dispense the sample and additional diluent to the RBC bath. In the meanwhile, additional diluent is
added to the RBC bath. The further diluted sample is used for RBC/PLT count.
6) Add and mix lyse to the WBC bath for reaction;
7) Run the analysis;
8) When the analysis completes, clean the WBC and RBC baths, zap the apertures, and release
the vacuum pressure.
The dilution procedure under whole blood mode is illustrated Figure 6- 1 as below:
6-7
Fluidics
1) Sample probe dispenses 700uL of diluent to the centrifugal tube. Then use a capillary tube to
add the 20uL of sample blood to the centrifugal tube. Well mix the sample.
2) Sample probe aspirates and dispenses 198uL of the prepared sample to the WBC bath. Add
diluent to the bath to fairly mix with the sample for WBC and HGB measurement.
3) Sample probe ascends. Its interior and exterior walls are cleaned.
4) The sample probe descends to the WBC to aspirate 37.7ul of diluted sample and then dispense
the sample to the RBC bath. In the meanwhile, additional diluent is added to the RBC bath. The
further diluted sample is used for RBC/PLT count.
5) Add and mix lyse to the WBC bath for reaction;
6) Run the analysis;
7) When the analysis completes, clean the WBC and RBC baths, zap the apertures, and release
the vacuum pressure.
You can see the analysis procedures under whole blood and predilute modes are basically the
6-8
Fluidics
same except for the sample aspiration procedure and the sample dispensing procedure to WBC bath.
The dilution procedure under predilute mode is illustrated Figure 6- 2 as below:
6-9
Fluidics
Function description: sample probe aspirates 23.1ul of the diluted sample (dilution
rate: 1:173.22) from the WBC bath, and dispenses the sample as well as additional
diluent to the RBC bath, where the sample and the diluent are further mixed with
existing initial volume of diluent (in all 2.2 ml diluent is used in this process) to get a
dilution of 1:16497.3. After full mixing and reaction, the sample solution is then
sucked into the back bath by vacuum pressure in the vacuum chamber. The cells are
counted when they pass the aperture. Sample volume is calculated based on analysis
time.
The diluent heating system consists of the diluent temperature detection unit and the preheating
unit. The heating control of the heating units is detected and managed by the diluent temperature
6-10
Fluidics
Appearance:
Function: a. check whether the diluent temperature fall in the range of [10°C,40°C]. When it is
out of the range, the analyzer will stop working and gives out alarm; b. provide diluent
temperature needed for the calculation of bath temperature.
6-11
Fluidics
The sample probe workflow is shown in Figure 6- 3. See section 6.2 for the sample dilution
procedure. The sample probe workflow can be divided into following steps:
a) Aspiration
① Aspirate 9ul of sample blood.
b) First dilution
① Sample probe aspirates required volume of sample, and move from the tube;
② Sample probe move horizontally to the position above the WBC bath;
③ Sample probe descends to the WBC bath and dispenses 9ul of sample.
c) Dispense initial volume to RBC bath
① Sample probe ascends from the WBC bath to the probe wipe where its interior
and exterior walls are cleaned;
② Sample probe whirls descending to the RBC bath, and dispenses initial volume to
the bath.
d) Aspirate sample dilution from WBC bath
③ Sample probe ascends from the RBC bath and whirls to the position above WBC
6-12
Fluidics
bath;
④ Sample probe descends into the WBC bath and aspirate 23.1ul of sample after
first dilution.
e) Second dilution in RBC bath
① Sample probe aspirates required volume of sample, and move from the WBC
bath;
② Sample probe move horizontally to the position above the RBC bath;
③ Sample probe descends into the RBC bath and dispenses the sample dilution.
④ Sample probe returns to its original position.
6-13
Fluidics
Figure 6- 3 Sampling
After the sample aspiration and dispensing procedure, the analysis will start. See Figure 6-4 for
the procedure. Build in the vacuum chamber a -30KPa vacuum which presses the sample solution in
the front baths of WBC and RBC baths to flow through the apertures to the back baths. The sample
solution in both the two back baths will then flow to the vacuum chamber in the direction indicated by
the red arrows.
As the analyzer only has two baths, the cleaning procedure is comparably simple :
1. Empty and prime the WBC bath;
6-14
Fluidics
The probe cleanser maintenance during the shutdown process involves the following parts: the
front and back baths of WBC and RBC baths, back bath tubing, sample probe as well as sampling
tubing.
The analyzer will perform "enhanced" probe cleanser maintenance after every 300 analyses.
Compared with normal probe cleanser maintenance, the enhanced process uses a longer probe
cleanser soak time (1 minute longer than normal maintenance).
Tap "Fluidic" on the "Maintenance" screen, the analyzer will perform enhanced probe cleanser
maintenance.
The fluidic actions during the startup consist of the following parts:
1 Initialization of fluidic components: initialize the aspiration module and syringe module, build
and release vacuum.
2 Overall cleaning: clean all the tubes, parts and components of the analyzer. Remove bubbles in
the diluent preheating bath. No lyse is consumed.
3 Background check: under whole blood mode.
If the background does not pass, the analyzer will perform the overall cleaning procedure one
more time, and then check the background again.
When the analyzer starts after abnormal shutdown, it will perform the overall cleaning procedure
twice.
6.7.3.3 Standby
The analyzer enters "Standby" mode when there is no action perform for 15~30 minutes
6-15
Fluidics
(configurable, 15 minutes by default) When the analyzer is standby, you can still perform operations
not involving fluidic actions.
Exit standby status1: standby for less than 1 hour
Clean the exterior wall of sample probe and WBC bath, re-build isolation bubbles. The process
does not consume lyse.
Exit standby status1: standby for more than 1 hour, but no longer than 3 hours.
Clean both the exterior and interior walls of sample probe, clean the WBC and RBC baths, re-
build isolation bubbles. The process does not consume lyse.
Exit standby status3: standby for more than 3 hours, but no longer than 12 hours.
Equivalent of overall cleaning; all the tubing, parts and components will be cleaned, remove
bubbles in the diluent preheating bath, remove the crystallization and bubbles at the diluent inlet.
Exit standby status4: standby for more than 12 hours.
Base on Exit standby status3, increase to remove bubbles in lyse tubing.
6-16
7 Hardware System
The hardware system not only consists of power board, main control board, indicator
board, touch screen control board and liquid detection board, but also the electrified drives
and components (e.g. motors, valves, pumps, sensors, screens, and power filters), as well as
the cables connecting different boards or connecting boards and components.
The hardware system consists of 5 major modules: system power, data flow channel, main
control system, drive parts and peripheral interfaces.
3. Main control system: collect and process data, display results and store sample information.
Besides, main control system acts as the control and management center which controls and
responds to all other components and devices.
4. Drives/detectors: control valves, pumps and motors; monitor the photocouplers and other
important parameters; collect information during analysis and send out flags.
5. Peripheral interfaces: include interfaces to display/touch screen, USB ports (connecting to 7-1
Hardware System
printer, keyboard, and barcode scanner) and Ethernet interface. Besides, peripheral interfaces
also include those to the working status indicator and the [Aspirate] key.
7.3.1 Overview
The main control board consists of analog module, digital module and power drive module;
among which, the analog module conditions and amplifies the signals from the impedance channel
and HGB channel as well as other analog signals like monitoring voltages, and converts them into
digital signals through the A/D converter. The digital module is responsible for the drive and control
7-2
Hardware System
of mechanical parts as well as the processing, outputting and communication of data. The power drive
follows the instruction of CPU to drive the motors, valves, pumps and heaters.
For troubleshooting information of the main control board, please refer to section 7.2.
7.3.2 Components
The structure of the main control board is illustrated in figure 8-6. It mainly consists of digital
circuits and several ADC circuits for A/D conversion. The digital circuit module is responsible for
processing data, saving and outputting results. Furthermore, as the core of the main control board and
even the whole hardware system, it takes the management and communication job. ADC circuits uses
A/D converters to convert analog value monitoring signals (like WBC, RBC, PLT counts etc.) to
digital signals.
The control function of the main control board is realized with a "CPU+FPGA" structure. The
main control board mainly provides the following functions:
A/D conversion
Data processing
Peripheral interface enabling
Control interface extending
Introduction
Drive module
7-3
Hardware System
Converts analog signals to digital signals which can be processed by FPGA or CPU.
Data processing
FPGA filters the digital signals collected during A/D sampling and saves the particular
parameters. It then transmits the data to CPU by various means (like interrupt control) for further
processing. The processed data will be displayed on the LCD screen.
Peripheral interface enabling
CPU module acts as the platform for software operation . It also enables the peripheral interfaces
like indicator board interface, LCD display interface, Ethernet interface, USB printer interface, and
the ports to barcode scanner, keyboard and USB. Besides, it provides a JTAG interface for FPGA
online programing, and a CPU debugging interface.
Control interface extending
Provide control logic and interfaces to the LCD screen, SD card, touch screen and recorder.
7-4
Hardware System
J25
J24
J26
J5
J42 J27
J28
J41
J43
J29
J30
J4
Definition of sockets
The main control board has 13 sockets. See Table 7-1 for the socket functions; see Figure 7-4 for
their positions.
7-5
Hardware System
7-6
Hardware System
7-7
Hardware System
If power errors are suspected, first pull out all other cables other than power cables to rule out
the possibility of any short-circuited peripheral.
Table 7-3 Functions of test points on the main control board
Test
No. Introduction Troubleshooting
Points
1 TP3 Touch screen /
interrupt signal
2 TP4 Touch screen /
reset signal
3 TP5 Digital ground /
cable
4 TP7 Backlight Voltage is 3.3V; main control board error
enabling signal
5 TP8 Backlight PWM Voltage is out of the range of 0.7V~1.2V; main
signal control board error
6 TP9 Backlight GND /
signal
7 TP61 5V voltage Voltage is not 5V; main control board or power
monitoring point board error
8 TP69 VDD 3.3V voltage Voltage is not 3.3V; main control board or power
monitoring point board error
9 TP70 VDD18 1.8 V Voltage is not 1.8V; main control board or power
voltage board error
monitoring point
10 TP71 VDD12 1.2 V Voltage is not 1.2V; main control board or power
voltage board error
monitoring point
11 TP80 VDD25 2.5 V Voltage is not 2.5V; main control board or power
voltage board error
monitoring point
12 TP84 Analog ground /
13 TP87 12V voltage Voltage is not 12V; main control board or power
monitoring point board error (ground for the voltage is not GND, but
J68_PIN2)
7-8
Hardware System
14 TP108 ADC U29 5.0V Voltage is not 5.0V; main control board error
reference voltage
15 TP109 ADC U30 5.0V Voltage is not 5.0V; main control board error
reference voltage
16 TP110 ADC U28 2.5V Voltage is not 2.5V; main control board error
reference voltage
7.4.1 Overview
The power board provides the analyzer with 6 units of reliable power output, including D5V,
A+12V, A-12V, AC120V. P24V and P12V.
Definition of interfaces
There are 6 interfaces to external systems on the power board; among which J1 to J4 are sockets,
L and N are AC input connecting cables, wiring from the side of the board to the sockets; the inverter
mini-board is directly inserted to the main board through a socket. The interface positions on the
power board are illustrated as below:
PIN Definition
L Live line terminal to AC
7-9
Hardware System
AC120V J4 AC
3. Open the power unit, remove the 4 fixing screws on the power board, and take out the board
from the power unit.
WARNING
Wear an antistatic wrist strap while removing the board;
Always shut down the power and pull out the power cable before removing the board.
Installation:
Install the power board in the reversed order of the disassembly steps.
Check:
1. Check whether all the screws on the board are properly fixed;
2. Connect the power cable, and turn on the AC switch. The analyzer starts its initialization, and
all the indicators on the board light on.
7-10
Hardware System
CAUTION
Ensure the power unit is tightly fixed to the main unit case with screws.
Before disassemble the power board, ensure the power board and its peripherals have cooled
off.
7.5.1 Introduction
As the interface between the touch screen and the main control board, the touch screen control
board transfers the touch actions from the users to recognizable signals by main control board. You
may need to make some adjustment to the touch screen control board during use.
7.5.2 Components
With the 4-wire touch screen controller chip TSC2004IRTJR as its core chip, the board
communicates with the main control board about touch point positions through an I2C interface.
7.6.1 Introduction
The indicator board informs about the working status of the analyzer by sending out sounds and
lights.
7-11
Hardware System
7.6.2 Components
The indicator board consists of a three color indicator (red, yellow and green) with its control
circuit as well as the buzzer drive circuit. You do not need to make adjustment to the indicator board
during use.
7.7.1 Introduction
Motors drive the aspiration module and syringe module etc.; photocouplers detect the motor
movements; and micro-switches are used to start analysis process. See below for the illustrations of
motors and photocouplers.
7.8.1 Introduction
The liquid detection board detects whether there is liquid in the tubes by monitoring the index of
refraction.
7-12
Hardware System
7.8.2 Components
The most important components of the board are the photocouplers. There is an LED indicator
on the back of the board, which will light off when the photocoupler is blocked between its
transmitting and receiving tubes, and light on when the photocoupler is blocked. You can use a piece
of paper to block the photocoupler and check whether the board is working properly.
7-13
Hardware System
7-14
Hardware System
2. Check whether the position no. marked on the cable correspond to the sockets there are
connected to; and whether the cables are broken or damaged;
3. Check whether the input power of sockets J4~J6 on the board are normal (measure the voltages
with a multimeter; refer to "Definition of sockets" for the pin functions).
4. Check whether the indicators on the main control board work properly against Table 7-2.
When you have confirmed all the cables are properly connected, all the input power and
indicators work normally, follow the instruction in Table 7-6 for troubleshooting.
Table 7-6 Troubleshooting for main control board
7-15
Hardware System
screen main control board and the backlight socket, and reconnect the cable
becomes the cable connecting the main control board and connecting the main
black. the LCD screen are properly connected. Unplug control board and
and then reconnect such cables. Power on the the backlight and the
analyzer again and see whether the error is cable connecting the
removed. If not, proceed to next step. main control board
and the LCD screen.
7-16
Hardware System
LCD screen. Power on the analyzer again and control board and
see whether the error is removed. If not, proceed the backlight and the
to next step. cable connecting the
main control board
and the LCD screen.
7-17
Hardware System
5 USB 1. If D10 and D12 do not light on when the Replace the
ports fail to analyzer is powered on, then the USB HUB chip main control board
response. (U1) is with error. If not the case, proceed to next
step
6 Clock time 1. Power off the analyzer, and use a Replace the
resets multimeter to measure the voltage between the button cell.
every time two ends of the button cell B1. When the
after measured voltage is <1.8V, then the cell is with
startup low power. If not the case, proceed to next step.
2. If the error still exists after the button cell Replace the
is replaced and the time is correctly reset, main control board
replace the main control board.
7 Analyzer 1. Check whether the cable connecting to
gives no the [Aspirate] key gets loose or broken. If yes,
respond reconnect the cable or replace it.
when the 2. If the error remains after step 1,
7-18
Hardware System
Error Possible
No. Solution
Description Cause
1 Touch screen Touch screen 1. Check whether the main control board
does not control board works properly (e.g. check whether the display
response error/touch screen screen displays normally, and whether the
when being error/poor analyzer can be operated with a mouse. If not, start
touched connection troubleshooting for the main control board first;
2. Check whether the connecting cable
between the touch screen drive board and the
main control board get loose or broken. If yes,
reconnect or replace the cable accordingly;
3. If the error remains after step 1 and 2,
replace the touch screen drive board;
4. If the error still remains, replace the touch
screen.
7-19
Hardware System
2 The cursor The cable 1. Check whether is any crack on the touch
only moves in connecting the screen. If yes, replace the touch screen.
horizontal or touch screen 2. Reconnect the cable connecting the touch
vertical control board and screen control board and the touch screen.
direction. the touch screen
gets broken
3 The cursor Touch screen is 1. Perform the touch screen calibration
cannot arrive not procedure to calibrate the touch screen again (if
at a certain calibrated/touch the cursor position deviates seriously from the
position screen gets intended touched position, so that you cannot even
cracked enter the touch screen calibration screen, use a
USB mouse to operate and enter the calibration
screen);
2. When the error still remains, check if there
is any crack on the touch screen. If yes, replace
the touch screen.
Error Error
No. Troubleshooting
type description
1 Indicator Indicator won't 1. Check whether the main control board works
light on properly (screen displays normally, and basic
operations like sample analysis and information
review can be run properly). When there is any
problem, start troubleshooting for the main control
board first;
2. Check whether the cables connecting to the
indicator board get loose or broken. If they get loose,
reconnect the cables; if they get broken, replace it as
well as the front panel signal cables;
3. If cable errors can be excluded, replace the
indicator board.
2 Buzzer Buzzer won't 1. Check whether the main control board works
sound when properly (screen displays normally, and basic
the analyzer operations like sample analysis and information
rings alarms review can be run properly). When there is any
problem, start troubleshooting for the main control
board first;
2. Check whether the cables connecting to the
indicator board get loose or broken. If they get loose,
reconnect the cables; if they get broken, replace it as
well as the front panel signal cables;
7-20
Hardware System
7-21
8 Mechanical System
8-1
Mechanical System
8-2
Mechanical System
8-3
Mechanical System
8-4
Mechanical System
8.2.1 Introduction
This section not only displays the explosive views of various assemblies of the analyzer, but
also lists the BOM for each assembly, so our service people may find the component quickly to
remove or replace them.
8-5
Mechanical System
NOTE
The material IDs listed in the BOM shall only be used by service people to find the material
numbers of maintenance spare parts. Provide the material ID when purchasing any
8-6
Mechanical System
3 Start key / /
4 Key installation board / /
8-7
Mechanical System
Maintenance spare
ID Material description Remarks
part ID
6 Insulation bar / /
7 Aspiration module 115-025638-00 /
8 Shielding bottom plate welding piece / /
New 3-way micro-electromagnetic valve (short line, new
9 801-3201-00003-00 /
connector)
10 WBC bath assembly 115-025645-00 /
15 Shielding box / /
16 Right door / /
8-8
Mechanical System
8-9
Mechanical System
Maintenance spare
ID Material description Remarks
part ID
25 Power unit 115-025646-00 /
8-10
Mechanical System
8-11
Mechanical System
8-12
Mechanical System
8-13
Mechanical System
8-14
Mechanical System
8-15
Mechanical System
8-16
Mechanical System
8-17
Mechanical System
8.3.1 Tools
You may need following tools to disassemble and replace mechanical components:
Flat-headed screwdriver
Tweezers
Nipper pliers
cutting nippers
8-18
Mechanical System
Stop using the analyzer and make sure the sample probe has returned to the
aspiration position. Shut down the analyzer, and disconnect all accessories
and external equipment.
All the analyzer components and surfaces are potentially infectious, so take proper
protective measures for operation and maintenance.
WARNING
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling
them and the contacted areas in the laboratory.
If reagents accidentally spill on your skin or in your eyes, rinse the area with ample amount
of clean water; seek medical attention immediately.
Eliminate static electricity before disassembly. While removing the components with
electrostatic sensitive mark, please wear protective equipment such like an anti-static wrist
strap or anti-static gloves to avoid ESD damage to the components.
Short circuit may be caused when wires are pressed or damaged. Connect and place the
wires properly while placing the components.
Use correct screws during re-installation. Using wrong screws may cause equipment
damage. Such screws and the parts fixed by them may become loose and fall off, resulting
in unexpected product damage or personal injury.
Disassemble the instrument in the specified order. Failing to do so may cause irreversible
damage to the instrument.
Make sure all cables have been disconnected before disassembling the components. Be
8-19
Mechanical System
Store the removed screws and other parts in separate places so you can find them easily
during re-installation. Be careful not to drop, contaminate or lose them.
Separately store the the disassembled materials by modules so you can find them quickly
and correctly during re-installation.
During re-installation, assemble the components first then the main unit. Be careful with the
wire connections. Place the wires in proper position.
CAUTION
To avoid the display screen gets scratched, make sure the analyzer is disassembled at a
position which is smooth and with no foreign object on it.
Carefully check all the fluidic tubes after assembly and make sure there is no bending or
folding.
8-20
Mechanical System
4. Unplug all the cables connecting to the main control board, and remove the 9 M3×8 screws.
Then take out the main control board (as shown below).
8-21
Mechanical System
5. Remove the 2 M3×8 screws to disassemble the lower signal shielding cover (as shown
below);
Installation:
Install the power board in the reversed order of the disassembly steps.
Verification:
1. Make sure all the cables connecting to the main control board are properly and
correctly connected;
2. Power on the analyzer and electrify the main control board. Check whether the main
control board analog power and its status indicator work normally;
3. Run a background test. If there is no alarm sounded, then main control board is
successfully replaced. Otherwise perform the troubleshooting procedure.
Note: When a main control board is replaced, restore the data on the SD card to the
new main control board; when an SD card is replaced, backup the data on the main control
board to the new SD card.
8-22
Mechanical System
4. As shown below, remove all the tubes below the bath, and take out the 2 M3 screws
fixing the bath assembly as well as the M3X8 screws. Remove the bath assembly.
8-23
Mechanical System
Installation:
Install the aperture sensor in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected;
CAUTION
Before removing the shielding box of a bath, adjust the position of the sample probe and
make sure it is not in the shielding box. Otherwise the sample probe may get bent or injure
the operator.
2. Follow the instructions in section 8.4.1 to remove the left door assembly and unplug
the connector of HGB unit from the main board.
3. As shown below, remove the 2 M3 screws fixing the bath cover and take out the
lower part of the WBC bath assembly. Rotate the HGB light assembly 90° counterclockwise
to remove it.
8-24
Mechanical System
Installation:
Install the aperture sensor in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.
CAUTION
Before removing the shielding box of a bath, adjust the position of the sample probe and
make sure it is not in the shielding box. Otherwise the sample probe may get bent or injure
the operator.
2. As shown below, unplug all the tubes of the preheating assembly and remove the 2
M3×8 screws. Then take out the heater and pull its connector out of the hole. Unplug the
connector of the cable to the preheating assembly (keep the connector at the left side of the
analyzer for re-installation).
8-25
Mechanical System
Installation:
Install the preheating assembly in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the electrical components are correctly connected.
3. Power on the analyzer and tap the “ ” button to enter the system menu. Select
"Status" →"Temp.&Pressure", and check whether the "Reagent Preheating Temperature"
column displays in red. If it is, then the error still exists.
2. As shown below, unplug all the tubes of the valve to be serviced, and remove the 2
M3×12 screws. Then take out the valve assembly and pull its connector out of the hole.
Unplug the connector of the cable to the valve (keep the connector at the left side of the
analyzer for re-installation).
8-26
Mechanical System
Installation:
Install the preheating assembly in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected;
3. Power on the analyzer and tap the " " button to enter the system menu. Tap
"Service" →“Self-Test" → "Valve Self-Test" to enter the valve self-test screen. Tap the valve
to be serviced (see the silk-screen on the fluidic spacer for the valve number), and see if it
can be turned on and off normally.
2. Remove the 2 M3×8 screws and take out the liquid detection board installation box
and PCBA.
3. Remove the tubes and cables connected to the liquid detection board and take out the liquid
detection board PCBA.
Note: During installation, the PCBA connector at the position should connect reagent tube, the
other connector should connect diluent tube.
Marked" L"
8-27
Mechanical System
2. As shown below, unplug all the tubes of the pump to be serviced, and remove the 4 M3×12
screws as well as the washers. Then take out the pump and pull its connector out of the hole. Unplug
the connector of the cable to the waste pump (keep the connector at the left side of the analyzer for re-
installation).
Installation:
Install the preheating assembly in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.
3. For the debugging and verification information of a certain component, refer to Chapter 11.
2. As shown below, unplug the tubes connected to the pump, cut off the cable ties. Then
remove the air pump and unplug the cable connectors.
8-28
Mechanical System
Installation:
Install the air pump in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.
3. For the debugging and verification information of a certain component, refer to Chapter 11.
2. Unplug the tubes connected to the vacuum chamber and remove the 2 M3×8 screws to take
out the vacuum chamber assembly.
Installation:
Install the vacuum chamber in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.
3. Power on the analyzer and tap the “ ” button to enter the system menu. Select "Status"
8-29
Mechanical System
→"Temp.&Pressure", and check whether the "Vacuum" column displays in red. If it is, then the error
still exists.
4. For the debugging and verification information of a certain component, refer to Chapter 11.
Installation:
Install the vacuum chamber in the reversed order of the disassembly steps.
Verification:
1. Make sure all the tubes and electrical components are correctly connected;
2. Power on the analyzer and tap the “ ” button to enter the system menu. Select "Status"
→"Temp.&Pressure", and check whether the "Diluent Temperature" column displays in red. If it is,
then the error still exists.
8-30
Mechanical System
2. Follow the instructions in 8.4.13 to remove the top cover. Unplug the cable connectors
connecting the motors and the upper and lower sensors from the aspiration module.
3. As shown below, remove the tubes and the 4 M3×12 screws as well as the washers. Then lift
up the aspiration module to remove it.
Installation:
Install the aspiration module in the reversed order of the disassembly steps.
8-31
Mechanical System
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.
3. Power on the analyzer and tap the " " button to enter the system menu. Select "Service" →
"Sample Probe Debug" to debug and confirm the up, middle and down positions of the sample probe
initial position and of WBC and RBC baths, so as to ensure the reliable operation of sample probe.
4. For the debugging and verification information of a certain component, refer to Chapter 11.
of Aspiration Module
1. Follow the instruction in section 8.4.14 to remove the aspiration module;
2. Remove the 4 M3×4 screws to disassemble the photocoupler assembly (as shown below);
Installation:
Install the photocoupler assembly in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Power on the analyzer and tap the " " button to enter the system menu, select ""Service"
→ "Sample Probe Debug" → "Initial position" to return the sample probe to the initial position, and
then tap "RBC Bath" and "Aspiration Position" to confirm that sample probe can move there
properly.
3. For the debugging and verification information of a certain component, refer to Chapter 11.
→ "Sample Probe Debug", and then tap "Initial position" to make the sample probe move to above
the WBC bath;
2. Follow the instruction in section 8.4.4 to remove the bath shielding box;
8-32
Mechanical System
3. As shown below, unplug the tube connected to the sample probe, and remove the M3 screw
and the fixing plate. Then remove the sample probe.
Installation:
Install the sample probe in the reversed order of the disassembly steps.
For the debug method of sample probe position, refer to section 11.2.
Verification:
1. make sure all the tubes are correctly connected;
2. Power on the analyzer and tap the " " button to enter the system menu. Select "Service" →
"Sample Probe Debug" to debug the up, middle and down positions of the sample probe initial
position and of WBC and RBC baths, so as to ensure the reliable operation of sample probe.
3. For the debugging and verification information of a certain component, refer to Chapter 11.
3. Remove the probe wipe from the right side (as shown below) and unplug the tube connected
to the probe wipe.
8-33
Mechanical System
Installation:
Install the probe wipe in the reversed order of the disassembly steps. Follow the instruction of
8.4.17 to adjust the sample probe positions.
Verification:
1. make sure all the tubes are correctly connected;
2. Power on the analyzer and tap the " " button to enter the system menu. Select "Service"
→ "Sample Probe Debug" to debug the up, middle and down positions of the sample probe initial
position and of WBC and RBC baths, so as to ensure the reliable operation of sample probe.
3. Restart the analyzer to perform the "sample probe cleaning" procedure, and check whether
there is liquid flowing from the bottom of the sample wipe.
4. For the debugging and verification information of a certain component, refer to Chapter 11.
Vertical Direction
1. Follow the instructions in 8.4.13 to remove the top cover. Unplug the cable connectors of the
photocoupler assembly of aspiration module motor.
2. Follow the instruction in section 8.4.3 to remove the right door;
3. tap the " " button to enter the system menu. Select "Service" → "Sample Probe Debug"→
"Initial Position"→ "RBC Bath" , Move the sample probe to the position above the RBC bath, and
use a diagonal pliers to cut the cable tie that fixing the photocoupler assembly cables. Remove the
cable connector.
4. Tap the "Aspiration pos" button , move the sample probe to the front aspiration position (as
shown below) and remove the M3×4 screw. Pull down and remove the photocoupler assembly from
the front side.
8-34
Mechanical System
Installation:
Install the photocoupler assembly in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the electrical components are correctly connected.
3. Power on the analyzer and tap the " " button to enter the system menu, select ""Service"
→ "Sample Probe Debug" → "Initial position" to return the sample probe to the initial position, and
then tap "Up", "Middle Position" and "Down Position" to confirm that sample probe can move there
properly.
4. For the debugging and verification information of a certain component, refer to Chapter 11.
2. Follow the instruction in section 8.4.1 to remove the left door assembly and remove the cables
of front cover assembly from the main control board;
8-35
Mechanical System
5. Remove the 6 M3×6 sunk screws locating at left, right and top sides. Then remove the front
cover assembly from the main unit and place it on a flat desktop.
8-36
Mechanical System
2. Remove the 2 M3×10 screws (as shown below), and then remove the indicator board shield
and the indicator board PCBA.
Installation:
Install the indicator PCBA in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. Power on the analyzer and make sure the status indicator light on.
8-37
Mechanical System
2. Remove the 2 M3×8 screws to disassemble the shielding box of the touch screen control
board (as shown below);
3. Unplug the cable connecting to the touch screen, and remove the 2 M3×8 screws. Then take
out the touch screen control board (as shown below).
Installation:
Install the touch screen control board in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
8-38
Mechanical System
3. Start the analyzer and check whether the touch screen works properly.
2. As shown below, remove the 4 M3×8 screws fixing the screen assembly, take out the screen
assembly and unplug all the cables connected to the screen.
Installation:
Install the touch screen assembly in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. Start the analyzer and check whether the display screen works properly.
2. As shown below, remove the 4 M3×8 screws fixing the screen assembly, take out the screen
assembly (no need to unplug the cables).
8-39
Mechanical System
3. As shown below, remove the 2 M3×8 screws, and take out the micro-switch assembly from
8-40
Mechanical System
the little hole on the front plate. Pull its connector out of the hole. Unplug the connector of the cable
to the micro-switch assembly (keep the connector at the left side of the analyzer for re-installation).
Installation:
Install the micro-switch assembly in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. The start key can be pressed down and then bounds up. And you can hear a clear click sound.
4. The analyzer runs analysis properly after startup.
3. As shown below, remove the 4 M3×12 screws as well as the washers, remove the syringe
assembly and unplug the cable connected to the syringe.
8-41
Mechanical System
4. Remove the 3 M3×8 screws and the tailored screw to disassemble the syringe (as shown
below).
Installation:
Install the syringe in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. For the debugging and verification information of a certain component, refer to Chapter 11.
2. As shown below, remove the 2 M3×12 inner hexagon screws fixing the shaft connector, and
then remove the 4 M3×12 inner hexagon screws fixing the motor. Remove the motor.
8-42
Mechanical System
Installation:
Install the motor in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. For the debugging and verification information of a certain component, refer to Chapter 11.
Assembly
1. Follow step 1 to 3 in 8.4.27 to remove the syringe assembly;
2. As shown below, remove the 2 M3×6 inner hexagon screws fixing the shaft connector, and
then remove the motor position photocoupler assembly.
Installation:
Install the motor position photocoupler assembly in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
8-43
Mechanical System
3. For the debugging and verification information of a certain component, refer to Chapter 11.
2. As shown below, remove the M3×8 screw and the isolation chamber holder. Then unplug the
tube connected to the isolation chamber filter to remove it.
Installation:
Install the isolation chamber filter in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes are correctly connected.
3. As shown below, remove the 5 M4×8 screws and pull out the power unit for a certain length.
Remove the ground screw on the left side.
8-44
Mechanical System
Installation:
Install the power unit in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
8-45
Mechanical System
Verification:
1. Check whether all the parts and components are properly installed and fixed;
8-46
9 Troubleshooting
Error Trigger Related Repair Parts Troubleshooting
Error Code
Name Mechanism and Tools Guidance
AD reference
Main 0x01000101 voltage out of
control range [2.4, 2.6]V 051-001714-00 Replace the main control
board Master Board PCBA board
error EEPROM data
0x01000102
incorrect
Constant current
source voltage Replace the main control
0x01000301
out of range [47, board
63]V
9-1
Troubleshooting
115-025649-00 Diluent
Pre_heating assembly
Preheat
bath Preheat bath 051-001714-00 Master
temperat temperature out Board PCBA
0x01000401
ure of range 009-004367-00
sensor (0,70) ℃ Temperature sensor
Go to the status screen and
error connecting cable
check whether the error
Multimeter exists;
Multimeter
801-3003-00015-00
Motor position sensor
assembly (FRU)
0x02nn0103 Other error.
051-001714-00 Master
Board PCBA
Lubricating grease
9-2
Troubleshooting
Lubricating grease
051-001714-00 Master
Board PCBA
9-3
Troubleshooting
Floater status:
Preheat
115-025649-00 Diluent
bath Preheat bath heating assembly Check the diluent heating
temperat 0x05000101 temperature assembly and main control
ure is higher than 45℃ 051-001714-00 Master board in turn
Board PCBA
too high
115-025649-00 Diluent
9-4
Troubleshooting
9-5
Troubleshooting
9-6
Troubleshooting
No
paper or No paper or Check whether there is
0x09000101 No paper or paper jam
paper paper jam no paper or paper jam
jam
9-7
Troubleshooting
9-8
Troubleshooting
connecting cable
115-025652-00 LCD
assembly (10.4″)
009-004364-00 LCD
screen connecting
cable
051-001714-00
Master Board PCBA
Multimeter
021-000073-00
Touch panel resistive
8.4inch 4-wires
009-004655-00
Small touch screen
used 801-3110-00184-00
/ / See section 7.9.4
improper Touch screen, 10.4″
ly 009-004366-00
Touch screen
connecting cable
051-000881-00 6301
Touch screen control
board PCBA
9-9
10 Adjustment
10.1 Adjusting Mechanical Positions
Figure 1.1
Point of Criteria of
Step Action
Control Control
10-1
Adjustment
Figure 1.2 Figure 1.3 Tap "Initial position", and then "Down position".
Adjust the screws of Check whether the sample probe gets into the bath
left-right position through the hole in the center of the bath cover, and
there is no interference between the probe and the
1.4 cover. If there is interference, adjust the relative
position again as instructed by steps in Section 5.4,
and do the check again to see if the position is
correct. The sample probe should not contact the
bath cover in the whole process.
Adjustthescrewsof Note:
1. In Figure 1.1, before tapping "Initial position" button, all other buttons are disabled. Only after
front-back position
you tap "Initialize", the other three buttons will be enabled. Only after you tap "WBC Bath"/"RBC
Bath", the "Middle position" and "Down position" buttons will be enabled.
10-2
Adjustment
10-3
Adjustment
Tap
MENU>"Service">"Temperature
calibration" to go to the
3.1 temperature calibration screen.
Tap the "Preheat bath
temperature" to go to the screen
shown in Figure 3.1;
Record the "Machine Test for the
measurement value", and enter calibration
Enter the sum of the
Value measured by 3.2 the sum of this value and the factor of the
measured value and
the instrument value in service FRU in the "Meter preheat bath
the value in FRU
measurement value" field. temperature
10-4
Adjustment
10-5
Adjustment
Observe the whole counting process, and WBC bath, RBC No splashes when
check whether the liquid level is normal bath dispensing liquid in
after dispensing liquid in WBC/RBC bath; WBC/RBC bath; bubbles
whether the sample probe tip is immersed can be made effectively;
in the liquid when the probe gets into the bubbles does not come
bath, whether there are splashes while into contact with the liquid
4.3
dispensing liquid, and whether there are dispensing tube; sample
bubbles when making bubbles; whether probe tip is immersed in
bubbles come into contact with the liquid the liquid; WBC and RBC
dispensing tube; whether the WBC bath baths can be emptied
and RBC bath can be emptied normally. normally, no liquid reside
on the wall of the bath;
Tap "Service">"Self-Test" to go to the Aperture voltage Aperture voltage normal;
self-test screen shown in Figure 4.1. Tap no error message.
4.4
"Aperture voltage RBC" and "Aperture
voltage WBC".
Install the shielding box of the bath and fix Secure the
4.5 it with M3X8 screws. Secure the screws screws.
using a cross-head screwdriver.
Start the count again. Observe the sample Sample probe Sample probe position in
probe action in the whole process. There position in relation to the bath
4.6 should be no interference between the relation to the shielding box position
sample probe and the shielding box while bath shielding
mixing the liquid in the bath. box position
Note: the gas column mentioned above is a large bubble that divides the liquid into segments in the
tubing.
10-6
11 Debugging and Validation After
Servicing
Component Service Adjustment
Validation
Name Material ID Requirement
Master Board PCBA 051-001714-00 1. Back up the Version information correct
configuration data as
instructed by the prompt on
the screen;
2. Check the version
information at the "Version
Info" screen.
Syringe transfer 115-020624-00 Calibrate again Check the repeatability
assembly
10ml Syringe 801-3003-00027
-00
Optical Sensor block 3101-20-68304
of injector
special bolt 3 041-005167-00
250ul syringe (with 115-027479-00
nozzle)
Sampling Assembly 115-025638-00 1. Make sure that there is Check the repeatability
no bent-over of tubes, and
no interference between the
Rotation Motor Pos 801-3003-00015 tubes and the front plate,
Sensor Assy -00 fluidic component partition,
right door, motors, valves,
wire harness retainers
Sensor Package 801-3001-00055 when the aspiration module
-00
is moving vertically or
horizontally;
2. Make sure that the tubes
Sample Probe Wipe 801-1805-00004
are not deformed when
Block -00
passing through the wire
harness retainers;
Sample probe 801-1805-00003 3. Make sure that the inlet
-00 and outlet tubes of the
probe wipe are not bent
over and there is no
interference when the
aspiration module is moving
vertically or horizontally;
11-1
Debugging and Validation After Servicing
11-2
Debugging and Validation After Servicing
3. If a wide 50 tube
connected to a valve or
connector is unplugged,
discard it and use a new
one for reconnection.
SMC 3-way 115-015967-00 / 1. Make sure that the
hydraulic valve connections to N.C, N.O,
(3106) and public ends are correct;
2. The rubber tube should
be inserted to the end;
3. If a wide 50 tube
connected to a valve or
connector is unplugged,
discard it and use a new
one for reconnection.
Panel assembly 043-005464-00 Perform screen calibration Make sure that the touch
(BC-30S) screen works properly
10 Inch Touch
047-005527-00
Screen Long Gasket
10 Inch Touch
047-005528-00
Screen Short Gasket
Panel assembly 043-005463-00
(BC-20S)
Long Gasket, IPM8
047-005535-00
Touch Screen
Short Gasket, IPM8
047-005536-00
Touch Screen
Touch screen, 801-3110-00184
10.4″, -00
Touch panel 021-000073-00
resistive 8.4inch
4-wires
LCD assembly 115-025652-00
(10.4″)
LCD assembly 115-025651-00
(8.4″)
Diluent Pre-heating 115-025649-00 1. The J9 and 3-way Make sure that the
assembly connector C10 must be temperature values are in
inserted to the end; specified ranges at the
2. Enter the parameters status screen
recorded by FRU in the
temperature calibration
screen to attain new
temperature values.
11-3
Debugging and Validation After Servicing
Lithium battery 3V M05-010R03--- Set time and date at the The date displayed after
35mAh D12.5*2.0 Date/Time Setup screen. restarting the analyzer is
Save the setting and shut the same as that before the
down the analyzer. shutdown.
SD card 8GB Class10 023-001056-00 1. Back up the data before /
replacing the SD card (if
possible);
2. Restore the
configuration data.
11-4
12 Service BOM
ID Name
115-025638-00 Sampling Assembly
801-1805-00003-00 Sample Probe
801-1805-00004-00 Sample Probe Wipe Block
801-3003-00015-00 Rotation Motor Pos Sensor Assy
801-3001-00055-00 Sensor Package
115-025639-00 Syringe assembly
801-3003-00027-00 10ml Syringe
115-027479-00 250ul Syringe(with nozzle)
115-025641-00 Vaccum/Pressure Chamber
115-025642-00 Reagent Detector Assembly
051-001621-00 Liquid Detect Board PCBA
043-000829-00 Reagent detection tube
115-025643-00 Waste pump assembly
115-025649-00 Diluent pre-heating assembly
115-025715-00 Air pump assembly
801-3201-00003-00 3-way Valve (Mindray)
115-015967-00 SMC 3-way hydraulic valve (3106)
801-3201-00002-00 2-way Valve (Mindray)
115-025644-00 RBC bath assembly
115-025645-00 WBC bath assembly
115-025640-00 HGB module
043-000711-00 Filter
801-1805-00023-00 Isolation chamber
042-011528-00 Shielding box
115-025646-00 Power box assembly
051-001714-00 Master Board PCBA
042-005949-00 Bottom signal shield
042-005948-00 Top signal shield
042-011531-00 Key mounting plate
115-025647-00 [Aspirate] key assembly
801-3007-00014-00 3007 Switch(FRU)
115-025648-00 Left Door Assembly
042-011533-00 Right door
042-011538-00 Top cover
M05-010R03--- Lithium battery 3V 35mAh D12.5*2.0
023-001056-00 SD card 8GB Class10
801-2800-00016-00 Recorder Module
115-015677-00 Diluent temperature detecting asm
Service BOM
12-2
13 Appendices
A. Fluidic diagram
Reagent Detection
C23
T47 T7
J11
T
2
3
SV07
T54
T11 C4
T13
C5
T
6
8
SV05 WBC RBC
C22
C2
T2
4
T
4 T19 5
T
1
8
J3-T34-
T
9
5
2
1
0
J
J
-
J4
T48
C20
J1-T33-J2
T25
T
Container
Preheating
T
1
0
bath
T
2
0
C13 C6 C7
T
T
4
9
4
9
T14
T35 T36
C14
T
5
1
Isolation Isolation
T
3
8
C19 Chamber 1 Chamber 2
SV02
T
3
C1
Lyse
T37
SV04
T
4
0
C3 SPB SV09 SV08
SV06
T26
T1
C15
2
T43
2 T17
C16 Temperature
sensor T
T42
T
5
4
4
6
J
J
-
-
C10 C11
T
T
1
6
2
1
T9 T39
T45-J8
C8 C9
J7-
T27
SV01 T22
T
4
1
SV03 T28
T55
T
4
6
C24
T2
C12
T
1
9
T15
C21
VC
T53
C17
Transducer
T32
GP
C18
Waste
WASTE LP
T
Container
3
0
T50
A-1
B. Connection and Tube
Information of Materials in the Fluidic Diagram
Name in the Location in
No. Material Type Diagram Material ID the Diagram Unit Quantity
1 Syringe SR 115-015652-00 D3 EA 1
2 WBC bath WBC 115-025645-00 A4 EA 1
3 RBC bath RBC 115-025644-00 A5 EA 1
4 Vacuum chamber VC 115-015673-00 C5 EA 1
5 Liquid pump LP 3001-10-07252 D4 EA 1
6 Gas pump GP 082-000221-00 D5 EA 1
7 Sample probe SPB 3001-10-07059 B3 EA 1
8 Probe wipe Probe wipe 3001-30-06957 C3 EA 1
Isolation
9 Isolation chamber chamber 1 115-002439-00 B4 EA 1
Isolation
10 Isolation chamber chamber 2 3003-20-34949 B5 EA 1
11 Heating bath Preheating bath 115-009948-00 B2 EA 1
Temperature
12 Sensor sensor 115-015677-00 A2 EA 1
Electromagnetic
13 valve SV1 115-010088-00 C2 EA 1
Electromagnetic
14 SV2 115-015967-00 B3 EA 1
valve
Electromagnetic
15 valve SV3 115-010089-00 C4 EA 1
Electromagnetic
16 valve SV4 115-010089-00 B4 EA 1
Electromagnetic
17 valve SV5 115-010088-00 A3 EA 1
Electromagnetic
18 valve SV6 115-010088-00 B2 EA 1
Electromagnetic
19 valve SV7 115-010088-00 A2 EA 1
Electromagnetic
20 valve SV8 115-010088-00 B5 EA 1
Electromagnetic
21 valve SV9 115-010088-00 B4 EA 1
25 Rubber tube T1 082-000108-00 C2 mm 240
26 Rubber tube T2 082-000108-00 C2 mm 210
27 Rubber tube T3 082-000108-00 B2 mm 270
28 Rubber tube T4 M90-000025--- B2 mm 20
29 Rubber tube T5 M90-000025--- B2 mm 20
30 Rubber tube T6 3001-10-07069 A2 mm 250
31 Rubber tube T7 3001-10-07069 A3 mm 60
32 Rubber tube T8 3001-10-07069 A4 mm 60
33 Rubber tube T9 082-000108-00 C2 mm 50
34 Rubber tube T10 M6G-020055--- B2 mm 1200
35 Rubber tube T11 082-000108-00 A2 mm 50
36 Rubber tube T12 082-000108-00 C2 mm 20
37 Rubber tube T13 082-000108-00 A2 mm 20
38 Rubber tube T14 M6G-020055--- B2 mm 270
39 Rubber tube T15 M6G-020054--- C2 mm 1500
40 Rubber tube T16 082-000108-00 C3 mm 440
B-1
Appendices
B-2
Appendices
B-3
C. Hardware block diagram
C-1
D. Cables and Wires
Material ID Name Connection
009-002857-00 Heater connecting wire Connects A-J21 with heater and
temperature switch
009-002858-00 Temperature sensor Connects A-J10 with temperature
connecting wire sensor
009-002863-00 Indicator board connecting Connects B-J78 with indicator board
wire
009-002865-00 Analog board supervisory Connects A-J2 and B-J86
signal wire
009-002866-00 Optical signal output wire Connects A-J4 and B-J85
009-002867-00 Analog main control board Connects A-J31 and B-J81
SPI signal wire
009-002869-00 Optical control signal wire Connects A-J3 and B-J77
009-002870-00 Syringe motor connecting Connects A-J32 and syringe motor
wire
009-002871-00 Digital power connecting Connects C-J1/C-J2 and A-J22/B-J68
wire
009-002872-00 Analog power connecting Connects A-J8 and C-J3 C-J4
wire
009-002875-00 Sampling motor connecting Connects A-J24 and sampling motor
wire
009-002877-00 Electromagnetic metering Connects A-J16 and electromagnetic
pump connecting wire metering pump
009-002878-00 Valve connecting wire Connects A-J14 A-J15 and valves
009-002880-00 Waste pump connecting Connects A-J20 and waste pump
wire
009-002881-00 Float switch connecting Connects A-J1 and float switch
wire
009-002882-00 Sampling photocoupler Connects A-J12 and sampling
connecting wire photocoupler
009-002911-00 Touchscreen control cable Connects B-J67 and touchscreen drive
board
009-002913-00 LCD signal wire Connects B-J4/B-J16 and LCD/backlight
009-002967-00 RBC connecting wire Connects A-J6 and RBC bath
009-002988-00 Safety ground /
009-002989-00 Component ground /
009-003176-00 Syringe assembly Connects A-J13 and syringe assembly
photocoupler connecting photocoupler
wire
009-003322-00 Start key connecting wire Connects B-J99 and start key
009-003381-00 Fan adapter cable Connects A-J17 A-J18 and fan
009-003642-00 Hydraulic sensor adapter Connects A-J11 and hydraulic sensor
cable
2800-20-28762 HGB connecting wire Connects A-J5 and HGB bath
009-004057-00 LH&DIFF detect board wire Connects A-J26 and Liquid detect
board PCBA
Note: A refers to the analog drive board, B refers to the main control board, and C refers to the
power board
D-1
Appendices
E. Menu Tree
Access Level
Level 1 Level 2 Level 3
Operator Administrator Service
Sample Analysis / / √ √ √
Table Review / / √ √ √
Setup √ √ √
L-J QC
Count √ √ √
QC
Setup √ √ √
X-B QC
Graph √ √ √
Manual / × √ √
Calibration Calibrator / × √ √
Fresh blood / × √ √
Background / × √ √
Performance Reproducibility / × × √
Carryover / × × √
Date/Time Setup √ √ √
Print setup √ √ √
System Setup Communication √ √ √
Shortcut Code Setup √ √ √
Lab Info Setup × √ √
Access
/ × √ √
Setup Management
Auxiliary Setup / √ √ √
Setting Reference Unit Setup × √ √
Parameters Reference Range Setup × √ √
Maintenance / × √ √
Reagent Setup / √ √ √
Gain Setup / × √ √
Maintenance / √ √ √
Self-Test / √ √ √
Sample Probe
/ × √ √
Debug
Gain
/ × √ √
Calibration
Service
Temperature
/ × √ √
calibration
Screen Cal. / √ √ √
Advanced
/ × √ √
Toolbox
Log / √ √ √
Counter / √ √ √
Temp &
/ √ √ √
Pressure
Status Voltage / √ √ √
Sensor / √ √ √
View √ √ √
Version Info
Upgrade × √ √
Logout / / √ √ √
Shutdown / / √ √ √
"√" indicates that this menu item is available at the access level; "×" indicates that this menu item is not
available at the access level.
E-3
F. Appendix Table
Product Model SN
Inspection
No. Description Requirement Result Conclusion
Item
See the diagrams
Electrical Safe and reliable
1 in the □OK □NG □PASS □FAIL
connections earthing
appendices
Having beeping
2 Beeping alarm / □OK □NG □PASS □FAIL
alarm
Correct time and
3 Time and date Time and date □OK □NG □PASS □FAIL
date
Version and
4 Version configuration Correct version □OK □NG □PASS □FAIL
information
See the section of
Mechanical Sample probe
"Adjusting
5 position position in relation □OK □NG □PASS □FAIL
Mechanical
validation to the WBC bath
Positions"
See the section of
Mechanical Sample probe
"Adjusting
6 position position in relation □OK □NG □PASS □FAIL
Mechanical
validation to the RBC bath
Positions"
Whether there is
bubble in the No bubble □OK □NG □PASS □FAIL
aspiration tubing
Whether there is
No suspended
liquid suspended at □OK □NG □PASS □FAIL
liquid
the sample probe tip
Sample probe is
under the surface of Sample probe
the liquid and does lower position □OK □NG □PASS □FAIL
not contact the normal
bottom of the bath
Whether there are
There are
bubbles when
bubbles when □OK □NG □PASS □FAIL
making bubbles in
making bubbles
the WBC bath
Counting
7 Whether there are
There are
Channel Test bubbles when
bubbles when □OK □NG □PASS □FAIL
making bubbles in
making bubbles
the RBC bath
In the process of
making bubbles in
the WBC bath,
whether there is No overflow or
□OK □NG □PASS □FAIL
overflow, and contact
whether the bubbles
contact the inlet
tube
In the process of
making bubbles in No overflow or
□OK □NG □PASS □FAIL
the RBC bath, contact
whether there is
F-1
Connection and Tube
overflow, and
whether the bubbles
contact the inlet
tube
Whether the WBC
bath is emptied Emptied normally □OK □NG □PASS □FAIL
normally
Whether the RBC
bath is emptied Emptied normally □OK □NG □PASS □FAIL
normally
Bath shielding box Screws are well □OK □NG □PASS □FAIL
installation fixed
No interference
Sample probe action when the sample □OK □NG □PASS □FAIL
probe is in action
No interference
between the
Sample probe tubing sample probe □OK □NG □PASS □FAIL
tubing and other
structures
Perform Refer to the
Instrument
8 maintenance and operator's □OK □NG □PASS □FAIL
maintenance
cleaning manual
WBC ≤0.2×109/L □PASS □FAIL
RBC ≤0.02×1012/L □PASS □FAIL
Background
9 HGB ≤1g/L □PASS □FAIL
test
HCT ≤0.5% □PASS □FAIL
PLT ≤5×109/L □PASS □FAIL
Able to print
10 Recorder Print analysis results □OK □NG □PASS □FAIL
properly
No error message
11 Shutdown Shutdown process □OK □NG □PASS □FAIL
or alarm
F-2
P/N: 046-007130-00(3.0)