New 3-DIFF Hematology Analyzer Service Manual - V7.0
New 3-DIFF Hematology Analyzer Service Manual - V7.0
New 3-DIFF Hematology Analyzer Service Manual - V7.0
SERVICE MANUAL
© 2012-2019 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2019-12.
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.
Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.
I
NOTE
This equipment must be operated by skilled/trained clinical professionals.
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
Malfunction of the instrument or part whose serial number is not legible enough.
Tel: 0049-40-2513175
Fax: 0049-40-255726
II
Table of Contents
1 Using This Manual ............................................................................................................. 1-1
1.1 Overview ................................................................................................................ 1-1
1.2 Who Should Read This Manual ............................................................................. 1-2
1.3 Using This Manual ................................................................................................. 1-2
1.4 Conventions Used in This Manual ......................................................................... 1-3
1.5 Safety Information ................................................................................................. 1-3
1.6 Symbols ................................................................................................................. 1-5
1
Table of Contents
2
Table of Contents
6 Fluidics 6-1
6.1 Introduction to Fluidic Parts ................................................................................... 6-1
6.1.1 Mindray valves ......................................................................................... 6-1
6.1.2 LVM fluidic valve ....................................................................................... 6-2
6.1.3 Linkage Syringe Device ........................................................................... 6-2
6.1.4 Preheating bath ........................................................................................ 6-3
6.1.5 Vacuum pump .......................................................................................... 6-4
6.1.6 Air pump ................................................................................................... 6-4
6.1.7 Sample probe ........................................................................................... 6-5
6.1.8 Probe wipes .............................................................................................. 6-6
6.1.9 Baths ........................................................................................................ 6-6
6.1.10 Filters ................................................................................................ 6-7
6.2 Sample Dilution Flow Chart ................................................................................... 6-8
6.2.1 Whole Blood Mode (for Dual-Bath Analyzers) ......................................... 6-9
6.2.2 Whole Blood Mode (for Single-Bath Analyzers Except BC-10e) ........... 6-10
6.2.3 Predilute Mode (for Dual-Bath Analyzers) .............................................. 6-12
6.2.4 Predilute Mode (for Single-Bath Analyzers) ........................................... 6-13
6.2.5 Whole Blood Mode (for Single-Bath BC-10e Only) ................................ 6-15
6.3 Introduction to Fluidic Channels .......................................................................... 6-16
6.3.1 Fluidic Channels for Dual-Channel Analyzers ........................................ 6-16
6.3.2 Fluidic Channels for Single-Channel Analyzers Except BC-10e ............ 6-18
6.3.3 Fluidic Channels for Single-Bath BC-10e .............................................. 6-19
6.4 Sample Volume ................................................................................................... 6-20
6.5 Temperature of Fluidics ....................................................................................... 6-20
6.5.1 Introduction to the Thermo System ........................................................ 6-20
6.5.2 Diluent Heating System .......................................................................... 6-21
6.6 Introduction to Sequences ................................................................................... 6-22
6.6.1 Analysis Sequence under Whole Blood Mode ....................................... 6-22
6.6.2 Analysis Sequence under Predilute Mode ............................................. 6-29
6.6.3 Introduction to Major Maintenance Sequences ...................................... 6-29
3
Table of Contents
4
Table of Contents
9 Troubleshooting................................................................................................................. 9-1
5
Table of Contents
13 Appendices.......................................................................................................................A-1
6
1 Using This Manual
1.1 Overview
This chapter describes how to use the service manual. In this manual, the repair methods of
Mindray’s new 3-DIFF series auto hematology analyzers, including BC-20s, BC-21s, BC-30s,
BC-31s, BC-10, BC-11, BC-20, BC-21, BC-30, BC-31, and BC-30e, and Mindray’s new
3-DIFF series hematology analyzer BC-10e are described in details.
Among which, analyzers BC-20s, BC-21s, BC-30s, BC-31s, BC-30, BC-31, BC-30e adopt
dual-bath design, and analyzers BC-10, BC-11, BC-10e, BC-20, and BC-21 adopt single-bath
design, that is, cancel the RBC bath and share the same bath for RBC and WBC count.
Analyzers BC-20s, BC-21s, BC-30s, BC-31s adopt sensors for detecting whether there is
reagent residue. While, analyzers BC-10, BC-11, BC-10e, BC-20, BC-21, BC-30, BC-31,
BC-30e use software to calculate the remaining reagent volume while cancel sensors for
detecting reagent.
Use Software
Adopt Use Sensors for Calculation
Adopt Dual-Bath
Analyzer Single-Bath for Reagent of Remaining
Design
Design Detection Reagent
Volume
BC-20s √ X √ X
BC-21s √ X √ X
BC-30s √ X √ X
BC-31s √ X √ X
BC-30 √ X X √
BC-31 √ X X √
BC-30e √ X X √
BC-20 X √ X √
BC-21 X √ X √
BC-10 X √ X √
BC-11 X √ X √
BC-10e X √ X √
The differences between the services of all models of analyzers are described in the following
context.
Before servicing analyzers, 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 Operator’s manual. It does not contain
1-1
Using This Manual
NOTE
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;
1-2
Using This Manual
troubleshooting
Debug after the 3-DIFF analyzers being serviced Chapter 10 Adjustment
Debugging and verification after the 3-DIFF analyzers Chapter 11 Debugging and
being serviced Validation After Servicing
learn about the 3-DIFF analyzers’ service BOM Chapter 12 Service BOM
learn about the 3-DIFF analyzers’ fluidic diagrams Appendix A Fluidic diagram
learn about the 3-DIFF analyzers’ fluidic tube connectors Appendix B Connection and
Tube
learn about the 3-DIFF analyzers’ hardware diagrams Appendix C Hardware block
diagram
learn about the 3-DIFF analyzers’ cables and wires Appendix D Cables and Wires
learn about the 3-DIFF analyzers menus and functions Appendix E Menu Tree
for different access levels
/ Appendix F Appendix Table
All illustrations in this manual are provided as examples only. They may not necessarily
reflect your analyzer setup or data displayed.
1-3
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.
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.
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.
1-4
Using This Manual
Check the equipment state after repair. Make sure the equipment is safe
before offering it to users.
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.
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.
1.6 Symbols
Symbols used in this service manual:
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
WARNING below this symbol. Failure to do so may cause
personal injury.
The operator is required to follow the instructions
below this symbol. Failure to do so may cause
CAUTION malfunction or damage of the product or affect the test
results.
1-5
Using This Manual
CAUTION
Ensure the labels are in good condition and not damaged while servicing the
analyzer.
Caution
Note: Indicates the need for the user to
consult the instructions for use for important
cautionary information such as warnings and
precautions that cannot, for a variety of
reasons, be presented on the medical device
itself.
Biological risks
(On) Power
Alternating current
1-6
Using This Manual
Serial number
Humidity limitation
Temperature limit
Date of manufacture
Manufacturer
1-7
2 Product Specifications
Model:BC-10e
Model:
BC-20s/BC-21s/BC-30s/BC-31s/BC-10/BC-11/BC-20/BC-21/BC-30/BC-31/BC-30e
Analyzer
Width (mm) ≤300
Height (mm) ≤400 (foot pad included)
Depth (mm) ≤410
Weight (Kg) ≤20
2-1
Product Specifications
BC-31s 10 inch
BC-20s 8 inch
BC-21s 8 inch
BC-30 10 inch
BC-31 10 inch
BC-30e 10 inch
BC-20 10 inch
BC-21 10 inch
BC-10 8 inch
BC-11 8 inch
BC-10e 8 inch
Parameter Value
Voltage (100V-240V~) ±10%
Frequency (50/60Hz)±1Hz
WARNING
Only fuses of specified specification shall be used.
2-2
Product Specifications
Storage and
Normal Operation Running
Transportation
Environment Environment
Environment
Requirements Requirements
Requirements
Ambient
15℃~30℃ -10℃~40℃ 10℃~40℃
Temperature
Relative
20%~85% 10%~90% 10%~90%
Humidity
Atmospheric
70kPa~106kPa Note1 50kPa~106kPa 70kPa~106kPa
Pressure
2.1.4.2 Throughput
Model Whole-Blood (WB) Mode Predilute (PD) Mode
BC-30s No less than 70 samples/hour No less than 70 samples/hour
2-3
Product Specifications
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%
Granulocyte percentage Gran%
Red Blood Cell count RBC
Hemoglobin concentration HGB
Mean Corpuscular Volume MCV
Mean Corpuscular Hemoglobin MCH
Mean Corpuscular Hemoglobin Concentration MCHC
Red Blood Cell Distribution Width Coefficient of Variation RDW-CV
Red Blood Cell Distribution Width Standard Deviation RDW-SD
Hematocrit HCT
Platelet count PLT
Mean Platelet Volume MPV
Platelet Distribution Width PDW
Plateletcrit PCT
Platelet Larger Cell Ratio P-LCR
Platelet Larger Cell Count* P-LCC*
Note: P-LCC only applies to BC-20s, BC-21s, BC-30s, BC-31s, BC-30, BC-31, and BC-30e.
2-4
Product Specifications
2.3.2 Carryover
Carryover refers to the carryover and contamination 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
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 2-7.
2-5
Product Specifications
Parameter Carryover
WBC ≤0.5%
RBC ≤0.5%
≤0.5%(applicable to BC-20s, BC-21s, BC-30s, BC-31s, BC-10,
HGB BC-11, BC-20, BC-21, BC-30, BC-31, and BC-30e)
≤1.0%(applicable to BC-10e)
PLT ≤1.0%
High Concentration
Parameter Unit Low Concentration Range
Range
WBC ×109/L > 15.00 < 3.00
RBC ×1012/L > 6.00 < 2.00
HGB g/L > 200 < 40
PLT ×109/L > 300 < 100
HCT % > 54.0 < 18.0
2.3.3 Repeatability
Test a sample which meets repeatability requirement for 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 ----standard deviation of sample test results;
x ----mean value of sample test results;
xi
----actual test result of the sample;
d ----absolute deviation of the sample test results.
2-6
Product Specifications
Table 2-10 Repeatability Requirements for BC-20s, BC-21s, BC-30s, BC-31s, BC-10,
BC-11, BC-20, BC-21, BC-30, BC-31, and BC-30e
Whole Blood
Predilute Repeatability
Repeatability
Parameter Condition (CV/absolute deviation
(CV/absolute deviation
d)
d)
(7.00~15.00) 109 /L ≤2.0%
WBC ≤4.0%
(4.00 ~ 6.90) 109 / L ≤3.5%
(3.50 ~ 6.50) 1012 / L ≤1.5% (applicable to ≤2.0% (applicable to
BC-20s, BC-21s, BC-30s, BC-20s, BC-21s, BC-30s,
BC-31s, BC-30, BC-31, BC-31s, BC-30, BC-30e,
and BC-30e) and BC-31)
RBC
≤2.0 % (applicable to ≤ 2.5%
BC-20. BC-21, BC-10,
(applicable to BC-20,
and BC-11)
BC-21, BC-10, and
BC-11)
HGB 100 ~ 180 g/L ≤1.5% ≤2.0%
70.00~110.00 fL ≤0.5% (applicable to ≤1.5%
BC-20s, BC-21s, BC-30s,
BC-31s, BC-30, BC-31,
MCV and BC-30e)
≤1.0% (applicable to
BC-20, BC-21, BC-10,
and BC-11)
(100 ~ 149) 109/ L ≤5.0% ≤8.0% (applicable to
BC-20s, BC-21s, BC-30s,
BC-31s, BC-30, BC-30e,
and BC-31)
≤10.0%
2-7
Product Specifications
2.3.4 Linearity
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.
Table 2-12 Linearity Requirements for BC-20s, BC-21s, BC-30s, BC-31s, BC-10, BC-11,
BC-20, BC-21, BC-30, BC-31, and BC-30e
Deviation Range
Parameter Linearity Range Deviation Range (Predilute)
(Whole Blood)
2-8
Product Specifications
WARNING
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.
2-9
Product Specifications
2-10
Product Specifications
2-11
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.
2-12
Product Specifications
analyzer in order to provide optimal system performance. Do not use the analyzer with
reagents from multiple suppliers. In such use, the analyzer may not meet the performance
specified in this manual and may provide unreliable results. All references related to reagents
in this manual refer to the reagents specifically formulated for this analyzer.
Each reagent package must be examined before use. Product integrity may be compromised
in packages that have been damaged. Inspect the package for signs of leakage or moisture.
If any sign of leakage or moisture is found, do not use the reagent.
NOTE
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.
2.6.1 Reagents
M-30D Diluent
As an isotonic reagent and with specified conductivity, M-30D diluent provides stable
environment for hematology analysis.
M-30CFL lyse is formulated to lyse red blood cells and transform the hemoglobin released
from red blood cell into hemoglobin complex. It is used for WBC count, WBC 3-part
differential and HGB determination.
M-20CFL Lyse (applicable to only BC-20, BC-21, and BC-30, BC-31, and BC-30e)
M-20CFL lyse is formulated to lyse red blood cells and transform the hemoglobin released
from red blood cell into hemoglobin complex. It is used for WBC count, WBC 3-part
differential and HGB determination.
M-10CFL lyse is formulated to lyse red blood cells and transform the hemoglobin released
from red blood cell into hemoglobin complex. It is used for WBC count, WBC 3-part
differential and HGB determination.
2-13
Product Specifications
M-3CFL Lyse
For use as a cyanide-free lytic reagent for quantitatively determining hemoglobin and for
counting and sizing leukocytes.
Probe Cleanser
BC-21s 20 analyzer.
BC-20 10
BC-21 10
BC-10 5
BC-11 5
BC-10e 3
2-14
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.
Reagent
Reagent
metering
WBC
Measurement
WBC
RBC
Human Machine
Reaction Management
Measurement
Processing
Parameter
Sample
Interface
Analysis
Signal
Data
open-vial
RBC
HGB
Aspirate/ diluenting
Measurement
Dispense
HGB Sample
Scheduling Control
Reaction Detected and Information
Power
Supply
Processing
Sample
Preparation
Status
Detection
Waste
Clean Collection
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
This analyzer can process two types of blood samples – whole blood samples and prediluted
blood samples.
For BC-10e:
If you are going to analyze a whole blood sample under the whole blood (WB) mode, present
the sample to the analyzer and press the [Aspirate] key, the analyzer aspirates 20μL of the
sample. Press the [Aspirate] key for the second time, a diluted sample (about 1:36) will be
dispensed. Mix the sample thoroughly, present the well-mixed diluted sample to the analyzer
and press the [Aspirate] key, the analyzer aspirates 198 uL of the sample.
If you are to analyze a capillary blood sample under the predilute (PD) 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.
For BC-20s, BC-21s, BC-30s, BC-31s, BC-10, BC-11, BC-20, BC-21, BC-30, BC-31,
and BC-30e:
If you are to analyze a whole blood sample under the whole blood (WB) mode, 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 predilute (PD) 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
3-2
System Principles
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.
WBC (109/L) is the number of leukocytes measured directly by counting the leukocytes
passing through the aperture.
Sometimes there are nucleated red blood cells (NRBC) presenting in the sample. While the
lyse will not be able to break their nuclear membrane, these NRBCs will also be counted as
WBCs. Therefore when NRBCs are found during microscopic exam, follow below formula to
modify the WBC count:
In the formula, WBC′ is corrected WBC count result; WBC is the WBC count provided by the
3-3
System Principles
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 calculates 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:
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 formulate, 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
3-4
System Principles
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).
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.
3-5
System Principles
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 thresholds of different channels, and the number of the pluses in the
RBC/PLT channel indicates the number of the RBC/PLT particles. The cell size distribution
width is represented by the number of particles falling in each channel.
RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes
passing through the aperture.
The analyzer calculates the mean cell volume (MCV, in fL) based on the RBC histogram.
3-6
System Principles
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.
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.
3-7
System Principles
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
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.
3-8
System Principles
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.
Flag type Flag Message Indication Conditions
Possible presence of
platelet coagulation, large
platelets, nucleated red
blood cells (NRBC), red
Abnormal cell size distribution of
WBC Histogram cells which are not broken
WBC histogram in the left of the
R1 down, protein with large
LYM region
molecular weight and lipid
particulars. It may also
suggest electrical noise
interference.
Possible presence of
atypical/abnormal Abnormal cell size distribution of
WBC Histogram lymphocytes, plasma cells WBC histogram in the region
R2 and blasts. Or extra-high between the lymphocyte peak
WBC
numbers of eosinophils and the mid-sized cell region.
and basophiles.
Abnormal cell size distribution of
Possible presence of
WBC Histogram WBC histogram in the region
immature cells and blasts;
R3 between the mid-sized cell
or eosinophilia.
region and the granulocyte peak.
Possible presence of
large immature cells, Abnormal cell size distribution of
WBC Histogram
blasts, WBC agglutination WBC histogram in the right of the
R4
or high absolute number granulocyte peak.
of granulocyte.
More than one abnormal
WBC Histogram At least 2 WBC histogram R
cell size distribution type
Rm flags are reported.
exists.
3-9
System Principles
3-10
System Principles
3-11
4 Software and Interface
4.1. Login
4.1.1 User ID and Password for Service Level Access
User ID: Service
Password: Se s700 (note there is a blank space between Se and s700).
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 they are matched, the
analyzer starts up successfully, performs a background test, and then displays the "Sample
Analysis" screen.
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.
All models of the new 3-DIFF series (auto) hematology analyzers use the
same main control board. The SD card of an analyzer carries the analyzer
type and calibration information. When a main control board is faulty, it can
be replaced with a new main control board but can only use its original SD
card.
4-2
Software and Interface
4.2 Review
4.2.1 Trend Graph
Operators can browse, validate, search, edit, and export data in the Table Review tab page.
Choose "Table Review" to enter the "Table Review tab" page, and then tap the "Trend
Graph" button to view the trend graph of sample results.
When the mean values 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 confirm 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
4.3.1 Calibration Factors
Calibration is performed to ensure the analyzer may deliver accurate sample analysis results.
During the calibration process, a calibrator factor will be calculated. This factor will be used to
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:
For
BC-20s/BC-21s/BC-30s/BC-31s/BC-10/BC-11/BC-10e/BC-20/BC-21/BC-30/BC-31/BC-30e,
the analyzer supports 3 calibration programs, namely manual calibration, auto calibration with
calibrators, and auto calibration with fresh blood samples.
Manual calibration can be performed under two modes: "WB" and "PD".
Auto calibration with fresh blood can be performed under two modes: "WB"
and "PD".
4-4
Software and Interface
Calibration with fresh blood can be performed under two modes: "WB" and "PD", which use
different fluidic sequences. Perform calibration with fresh blood for each of the two modes
separately.
All the parameters or part of the parameters of WBC, RBC, HGB, MCV and PLT can be
calibrated by the calibration programs.
The following content describes only how to perform auto calibration with calibrators for
BC-20s/BC-21s/BC-30s/BC-31s/BC-10/BC-11/BC-10e/BC-20/BC-21/BC-30/BC-31/BC-30e.
For details on manual calibration, auto calibration with calibrator, and auto calibration with
fresh blood, see the operator's manual of the corresponding analyzer.
4-5
Software and Interface
CAUTION
Only Mindray-specified calibrators shall be used. Mindray will not be
responsible for any erroneous result caused by using other calibrators.
See the instruction for use of the calibrators for the lot No., expiration date
and the target.
NOTE
If the calibrated factors or CVs are out of allowable range, they will be
displayed in red, and the values cannot be saved.
For BC-10e, choose Calibration > Gain Calibration to enter the gain calibration screen, as
shown in Figure 4-6.
Then, click the WBC histogram to check whether the WBC histogram is properly displayed
and determine how to adjust the gain setup if necessary, as shown in Figure 4-7.
For details on whether to adjust and how to adjust the gain setup, see 4.5 Gain Setup and
refer to the corresponding setting document.
4-6
Software and Interface
4-7
Software and Interface
You can calibrate the gain factors for all parameters displayed above at the same time.
Among the parameters, the WBC/RBC effective width is calibrated by software with
averaging method. Tap the "Select" boxes to select the results used to calculate the mean
values. WCP, MCP and HGB gains instead are hardware gains and calibrated with
successive "approximation method". They are not affected whether any group of results is
"selected".
Invalid calibration results will be displayed in red. In this case, do the calibration again.
If the target of a parameter is not set, the parameter will not be calibrated (like MCP on
above figure).
The system will ask if you want to save the calibration factors when exiting the Gain
Calibration screen.
CAUTION
The function only supports the calibration with calibrators.
4-8
Software and Interface
As the HGB gain is hardware gain, you need to adjust the blank voltage of the digital
potentiometer. Tap the "Auto Cal. HGB B.V" button, and the HGB blank voltage will be set
automatically.
MCP is the target RBC gain value for the calibrator. WCP is the target WBC gain value for the
calibrator. Service engineers and higher-priority users can input the target gain value
according to the target value sheet to calibrate the gain for the analyzer.
NOTE
As the gain settings affect the validity of analysis results, be careful when
you adjust them.
4-9
Software and Interface
4-10
Software and Interface
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 10.1
Adjusting Mechanical Positions.
4.7 Performance
NOTE
For BC-10e, the performance measurement function needs to be performed
manually according to the corresponding formulas. to evaluate the
background, reproducibility, and carryover.
4-11
Software and Interface
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.
4-12
Software and Interface
4.7.2 Reproducibility
Test a sample which meets reproducibility requirement for 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.
4-13
Software and Interface
4.7.3 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:
First low - level sample result -Third low - level sample result
Carryover(%) 100%
Third high - level sample result -Third low - level sample result
4-14
Software and Interface
4-15
Software and Interface
NOTE
When you change the language setting, the new language will only become
effective after restart.
When "Org pulse enable" is enabled, the original pulse will be saved to the SD card of the
analyzer.
Mid Width
The Mid Width function can be used to tune the mid-sized cell classification line.
NOTE
The USB should have been formatted to FAT32 before you copy and paste
the "update" directory to it.
Make sure there is enough free space (at least 4G) on the USB.
4-16
Software and Interface
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".
4.9.2 Update
Insert the USB to one of the USB ports on the analyzer, and perform update following either
of the below methods:
4-17
Software and Interface
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.
4-18
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
4-19
Software and Interface
4.11 Buzzer
When there is any error, the buzzer gives out an alarm sound. Tap the touch screen to silence
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.
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 when it is not convenient to start
analysis
The analyzer screen becomes Silent When there is/are error(s) during
black, and prompts "Please turn off shutdown process, the buzzer
the power of the analyzer!" stops when the analyzer screen
becomes black.
4-20
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
When using a wireless network, insert the wireless network card, and tap the button
on the right of the pull down list, the following dialog box is displayed.
5-1
Data Transmission
Select a Wi-Fi network, and then click the "Connect" button to connect the Wi-Fi
network.
EDUP:EP-N8508GS
Communication protocol: Tap the pull down list to select a suitable communication protocol.
5-2
Data Transmission
NOTE
The IP address for the analyzer is assigned statically. Ask your network
administrator for the IP address to avoid IP conflict.
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.
5-3
Data Transmission
Comm Protocol: HL7, 8ID and 10ID serial communication protocols are supported.
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
5-5
Data Transmission
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
Appearance:
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 NO.(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
solenoid 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
Appearance
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.
6-2
Fluidics
High volume bathes, dispense liquid to the probe wipes, and supports
Full range: 10ml
syringe 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.
NOTE
RBC bath applies to only dual-bath analyzers, including BC-30s, BC-31s,
BC-20s, BC-21s, BC-30, BC-31, and 30e.
The single-bath analyzers, including BC-20, BC-21, BC-10, BC-11, and BC-10e
are not configured with an RBC bath, and they use a WBC bath for the
measurement of HGB and WBC and then for the measurement of RBC/PLT.
6-6
Fluidics
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.
NOTE
An RBC isolation chamber applies to only dual-bath analyzers, including
BC-30s, BC-31s, BC-20s, BC-21s, BC-30, BC-31, and 30e. The single-bath
analyzers, including BC-20, BC-21, BC-10, BC-11, and BC-10e are not
configured with RBC isolation chambers.
6.1.10 Filters
Isolation chamber filters: filter the impurities and debris from the WBC bath.
6-7
Fluidics
Table 6-2 Comparison of the sample dilution flows of different models of new 3-DIFF
series (auto) hematology analyzers
Sample Dilution
WB Mode PD Mode
Flow Chart for
New 3-DIFF See 6.2.1 Whole Blood Mode (for See 6.2.3 Predilute Mode (for
series dual-bath Dual-Bath Analyzers). Dual-Bath Analyzers).
auto hematology
analyzers
(BC-30/31/30e/20
s/21s/30s/31s)
New 3-DIFF See 6.2.2 Whole Blood Mode (for See 6.2.4 Predilute Mode (for
series single-bath Single-Bath Analyzers Except Single-Bath Analyzers);
auto hematology BC-10e); The sample dilution flow chart of
analyzers The sample dilution flow chart of new 3-DIFF series single-bath
(BC-10/11/20/21) new 3-DIFF series single-bath auto hematology analyzers in PD
auto hematology analyzers in WB mode is consistent with the that of
mode is consistent with that of new 3-DIFF series dual-bath auto
new 3-DIFF series dual-bath auto hematology analyzers in PD
hematology analyzers in WB mode.
mode. New 3-DIFF series single-bath
New 3-DIFF series single-bath auto hematology analyzers adopt
auto hematology analyzers adopt only one bath. When the sample
only one bath. When the sample probe aspirates sample from the
probe aspirates sample from the bath for the second time, it stores
bath for the second time, it stores the sample in its sample probe
the sample in its sample probe until the WBC count is complete,
until the WBC count is complete, and then dispenses the stored
and then dispenses the stored sample to the bath for RBC and
sample to the bath for RBC and PLT count.
PLT count.
New 3-DIFF See 6.2.5 Whole Blood Mode (for The sample dilution flow chart of
series single-bath Single-Bath BC-10e Only). new 3-DIFF series single-bath
6-8
Fluidics
6-9
Fluidics
5. The sample probe whirls and descends to the WBC to aspirate 23.1ul of diluted sample,
and then dispenses the sample and additional diluent to the RBC bath. The diluted
sample is used for RBC/PLT count.
6. The analyzer adds lyse to the WBC bath and mixes for reaction;
7. The analyzer runs the analysis;
8. When the analysis completes, the analyzer cleans the WBC and RBC baths, zaps the
apertures, and releases the vacuum pressure.
The dilution procedure is illustrated as shown in Figure 6-1.
Aspirate 9ul
sample
Diluent
1.55ml
Figure 6-1 Dilution under whole blood mode (for dual-bath analyzers)
BC-10e)
Compared to old models, the analyzer adopts a "single aspiration" method for whole blood
analysis. The basic procedure is as follows:
1. The sample probe aspirates 9uL of sample blood and ascends. In the meanwhile, the
6-10
Fluidics
Aspirate 9ul
sample
Diluent
1.55ml
Figure 6-2 Dilution under whole blood mode (for single-bath analyzers)
6-11
Fluidics
20ul of whole
blood sample
700ul of diluent
1:36 dilution
198ul
1352ul of
diluent
37.7ul
1:281.82
dilution
6-12
Fluidics
7. When the analysis completes, the analyzer cleans the WBC and RBC baths, zaps the
apertures, and releases the vacuum pressure.
You can see the analysis procedures under whole blood and predilute mode are basically the
same except for the sample aspiration procedure and the sample dispensing procedure to
WBC bath.
The dilution procedure is illustrated as shown in Figure 6-4:
Capillary blood
sample 20ul
Configure the
Diluent 700ul dilution
manually
Dilution ratio:
1:36
Aspirate
198ul
Diluent sample
1352ul
6-13
Fluidics
3. The sample probe ascends and cleans its interior and exterior walls.
4. The sample probe descends to the bath to aspirate 37.7ul of diluted sample, and then
saves it in the sample probe for RBC/PLT count.
5. The analyzer adds lyse to the bath and mixes for reaction;
6. The analyzer runs the WBC count and HGB measurement;
7. When the analysis completes, the analyzer cleans the bath and zaps the apertures.
8. The analyzer adds initial volume to the bath and adds the aspirated sample that stored in
the sample probe to the bath to well mix them.
9. The sample probe ascends. Its interior and exterior walls are cleaned.
10. The analyzer runs the RBC count and PLT count.
11. When the analysis completes, the analyzer cleans the bath, and releases the vacuum
pressure.
The dilution procedure is illustrated as shown in Figure 6-5:
Capillary blood
sample 20ul
Configure the
Diluent 700ul dilution
manually
Dilution ratio:
1:36
Aspirate
198ul
Diluent sample
1352ul
First measure
Then measure
WBC/HGB
RBC/PLT
6-14
Fluidics
6-15
Fluidics
20ul of whole
blood sample
700ul of diluent
1:36 dilution
198ul
1352ul of
diluent
37.7ul
1:281.82
dilution
1. M-30PCFL cyanide-free lyse (break out RBCs and PLTs and 3-differentiate WBCs
based on cell size);
2. M-30PD diluent (used for cleaning, and providing appropriate environment for reaction
6-16
Fluidics
and measurement)
Measurement principle: impedance method (for WBC count); colorimetric method (for
HGB measurement)
Function description: 9ul blood sample and 1.55ml diluent are mixed in the WBC bath
to get diluted sample; of which 23.1ul is dispensed to the RBC bath, and the remain
diluted sample is mixed with 0.31ul of lyse. The sample solution after full reaction 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.
Function description: the 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.
6-17
Fluidics
BC-10e
A single-channel analyzer has only one bath, which is used for WBC/HGB count first and then
for RBC/PLT count.
1. M-30PCFL cyanide-free lyse (break out RBCs and PLTs and 3-differentiate WBCs
based on cell size);
2. M-30PD diluent (used for cleaning, and providing appropriate environment for reaction
and measurement)
Measurement principle: impedance method (for WBC count); colorimetric method (for
HGB measurement)
Function description: 9ul blood sample and 1.55ml diluent are mixed in the WBC
bathto get diluted sample; of which 23.1ul is aspirated and stored for RBC/PLT count,
and then 0.31ul lyse is added in the WBC bath and mixed. The sample solution after full
reaction 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.
6-18
Fluidics
Function description: After the WBC/HGB count is completed, the sample probe
dispenses the stored 23.1ul of the diluted sample (dilution rate: 1: 173.22) as well as
additional diluent to the WBC 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.
Measurement principle: impedance method (for WBC count); colorimetric method (for
HGB measurement)
Function description: The sample probe aspirates 20ul of blood sample, and then
dispenses the sample together with 700uL of dilution. Manually well mix the sample. The
sample probe aspirates 198ul of the sample, adds the sample with 1.35ml diluent, and
then aspires and stores 37.7uL of the sample mixture for RBC/PLT count. Then, the
sample probe adds 0.31ul of lyse in the WBC bath and mix them. The sample solution
after full reaction 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.
6-19
Fluidics
Function description: After the WBC/HGB count is completed, the sample probe
dispenses the stored 37.7ul of the diluted sample (dilution rate: 1:281.82) as well as
additional diluent to the WBC 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 1:16445.7. 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.
WB Mode PD Mode
3-DIFF series single-bath auto
hematology analyzers ≤ 9μL ≤ 20μL
(BC-10/11/20/21)
6-20
Fluidics
Diluent Temperature
Detection Unit
Reaction Bath
Temperature
J27 Detection Unit
PIN3 Temperature Preheating
Main Control Switch Assembly
Board
J11
PIN4
Symbol:
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.
6-21
Fluidics
a) Aspiration
① Aspirate 9ul of sample blood.
b) First dilution
① Sample probe aspirates required volume of sample, and moves from the tube;
② Sample probe whirls to the position above the WBC bath;
③ Sample probe descends to the WBC bath and dispenses 9ul of sample.
6-22
Fluidics
③ ①
WBC
Diluent Sample
a) b)
② ②
③ ① ③
①
RBC WBC RBC WBC
Diluent First
base c) d) dilution
②
③ ①
RBC WBC
Second
dilution e)
b) First dilution
6-23
Fluidics
① Sample probe aspirates required volume of sample, and moves from the tube;
② Sample probe whirls to the position above the bath;
③ Sample probe descends to the bath and dispenses 9ul of sample.
④ Sample probe ascends from the bath to the probe wipe where its interior and
exterior walls are cleaned;
③ ①
WBC
Diluent Sample
a) b)
① ② ②
①
RBC
WBC count
count
First
Second
dilution
c) d) dilution
Figure 6-8 Sampling and dispensing process (for single-bath analyzers except BC-10e)
6-24
Fluidics
b) Diluent dispensing
① The sample probe adds the sample with 700uL of dilution, and then dispenses
them in a centrifugal tube.
c) First dilution
① Sample probe aspirates required volume of sample, and moves from the tube;
② Sample probe whirls to the position above the bath;
③ Sample probe descends to the bath and dispenses 198ul of sample.
④ Sample probe ascends from the bath to the probe wipe where its interior and
exterior walls are cleaned;
6-25
Fluidics
①
①
Sample
Sample centrifugal
a) tube b)
① ①
WBC
Diluent centrifugal
tube
c)
① ① ①
①
RBC
WBC coun
count t
First Secon
dilution d
e) dilution
d)
Figure 6-9 Sampling and dispensing process (for single-bath analyzer BC-10e
6-26
Fluidics
T23
WBC RBC
T24
J3-T34-J4
J1-T33-J2
T25
C6 C7
T35 T36
SV04
T26
C8
T27
T28
T55 C24
T29
C21
VC
T53
Transducer
6-27
Fluidics
PS
T27
T23
T26
T21 C12
T25
T22 T24
WBC T29
6-28
Fluidics
6-29
Fluidics
6.6.3.3 Standby
The analyzer enters "Standby" mode when there is no action performed for 10~90 minutes
(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.
6-30
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.
Signal
preconditioning Embedded
Impedance channel
Colorimetry channel
Large memory
Vacuum building
Reaction bath
Power driving
temperature
temperature
User interaction
detection
Diluent
control
7-1
Hardware System
Aperture
RBC bath
Stepping Aperture driving
motor and impedance signal
Wired network
Sensor interfaceX1
Syringe assembly
Stepping
motor X2
Aspiration module Recorder
Electromagnetic
valveX12
Aspirate key
Liquid detection
board Indicator board
LCD screen data
P12V
P24V LCD screen
D5V Backlight control (touch
A12V_P/N screen)
Touch
Power D5V screen Touch screen
assembly P12V data control board
Front cover assembly
Main control board
7-2
Hardware System
7.3.2 Components
The structure of the main control board is illustrated in Figure 7-3. 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
7-3
Hardware System
EEPRO
DDR2 SDRAM
M
CPU
C Touch screen
FPGA
(RBC/WBC/HGB/monitor)
TFT screen
2. A/D conversion
Converts analog signals to digital signals which can be processed by FPGA or CPU.
3. 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.
7-4
Hardware System
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
J5 Socket to PIN1,2: 5V /
digital circuit PIN3,4: GND
J8 Socket to / /
syringe motor
J9 Socket to valve / /
and pump drive
J12 Socket to / /
photocoupler
signals
7-6
Hardware System
printer interface
J19 Socket to / /
keypad
interface
7-7
Hardware System
D1, D2 Network socket indicator: when Network not connected, network cable
the network cable is properly damaged, error with main control board
connected to the PC, D2 lights on,
while D1 flickers
D5~D12 USB indicators. D10 and D12 Power board error, DC circuit cable
always on; D6~D9 respectively error, and main control board error.
corresponds to the 4 USB
interfaces and only lights on when
a USB device is inserted.
D13~D18 Motor indicator; flicker when a Power error, main control board error
motor is moving
D21 FPGA Operation indicator CPU buckle plate error, SD card error,
main control board error
7-8
Hardware System
Test
No. Introduction Troubleshooting
Points
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
7-9
Hardware System
monitoring point
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)
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
7-10
Hardware System
Appearance of Power Unit One big square board One big square board and
one small square board
They can be distinguished from each other from their appearance and number of consisting
power boards.
7-11
Hardware System
PIN Definition
L Live line terminal to AC
7-12
Hardware System
Power Assembly
The power board plays a very important part in the device, and any error with the board may
endanger the operation of the whole. Follow below steps to replace the power board when
needed:
Disassembly:
WARNING
Wear an antistatic wrist strap while removing a board;
Always shut down the power and pull out the power cable before removing a
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.
CAUTION
Ensure the power assembly 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.
7-13
Hardware System
The relationship between the wire colors and the output voltage of their connected interfaces
are listed below:
Yellow 12V
Red 5V
7-14
Hardware System
7.4.5 Power Board Replacing and Wiring for the New Power
Assembly
Power boards play a very important part in the device, and any error with a power board may
endanger the operation of the whole. Follow below steps to replace a power board when
needed:
Disassembly:
WARNING
Wear an antistatic wrist strap while removing a board;
Always shut down the power and pull out the power cable before removing a
board.
Installation:
Install the two power boards in the reversed order of the disassembly steps.
Check:
1. Check whether all the screws on the two power boards are properly fixed;
2. Connect power cables, and then turn on the AC switch. The analyzer starts its
initialization, and all the indicators on the two boards light on.
CAUTION
Ensure the power assembly is tightly fixed to the main unit case with screws.
Before disassemble a power board, ensure these power boards and their
peripherals have cooled off.
7-15
Hardware System
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.
I2C Touch
Pinaster main
screen Touch screen
control board
drive board
7-16
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.
7-17
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.
7-18
Hardware System
Does the
fuse of the power N
Replace the fuse
assembly work
properly?
Y
Is
the voltage Replace the AC
at the output pin N power cord. If the
normal after the filter voltage is still
switch is abnormal, replace
closed? the filter
7-19
Hardware System
7-20
Hardware System
2. Replace the cable connecting the main control Replace the cable
board and the backlight and the cable connecting the main
connecting the main control board and the LCD control board and
screen. If the error still exists, proceed to next the backlight and the
step. cable connecting the
main control board
and the LCD screen.
6. Replace the LCD screen. If the error remains, Replace the LCD
proceed to next step. screen
7-21
Hardware System
3. Replace the main control board. If the error is Replace the main
removed, then the problem is caused by control board
differential conversion chip (U10) or board
AM1808 failure. If not, proceed to next step.
3 LCD 1. Reconnect the cable connecting the main Reconnect the cable
displays control board and the LCD screen. Power on the connecting the main
strange analyzer again and see whether the error is control board and
patterns removed. If not, proceed to next step. the LCD screen.
2. Replace the cable connecting the main control Replace the cable
board and the LCD screen. If the error still exists, connecting the main
proceed to next step. control board and
the LCD screen.
4. Replace the main control board. If the error Replace the main
remains, proceed to next step. control board
7-22
Hardware System
4 Bad 1. Check whether the IP of the PC falls in the Set the IP of the PC
network same network segment of the main control board to 10.0.0.3.
connection IP (10.0.0.X). When it is not, reset the IP of the
PC to 10.0.0.3, and see whether the network
connection is OK. If the network connection still
fails, proceed to next step.
2. When the analyzer is powered on and Reconnect or
connected to PC, but D1 and D2 do not light on, replace the network
then the network connection is bad or the cable.
network cable is damaged. If not the case,
proceed to next step.
5 USB ports 1. If D10 and D12 do not light on when the Replace the main
fail to analyzer is powered on, then the USB HUB chip control board
response. (U1) is with error. If not the case, proceed to next
step
2. If D10 and D12 do light on when the analyzer Replace the devices
is powered on, replace the peripherals connecting to the
connected to the USB ports (mouse, keyboard or USB ports.
USB disk etc.). If the peripherals still cannot be
used, proceed to next step.
3. If the error still remains after all above steps, Replace the main
replace the main control board. control board
6 Clock time 1. Power off the analyzer, and use a multimeter Replace the button
resets to measure the voltage between the two ends of cell.
every time the button cell B1. When the measured voltage is
after <1.8V, then the cell is with low power. If not the
startup case, proceed to next step.
2. If the error still exists after the button cell is Replace the main
replaced and the time is correctly reset, replace control board
the main control board.
7 Analyzer 1. Check whether the cable connecting to the
gives no [Aspirate] key gets loose or broken. If yes,
7-23
Hardware System
Check the
Is the AC input components
N
voltage normal? including the filter,
fuse
Error
No. Possible Cause Solution
Description
1 Touch screen Touch screen 1. Check whether the main control board works
does not control board properly (e.g. check whether the display screen
response error/touch screen displays normally, and whether the analyzer can
when being error/poor 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
7-24
Hardware System
2 The cursor The cable 1. Check whether is any crack on the touch screen.
only moves in connecting the 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 procedure
cannot arrive not to calibrate the touch screen again (if the cursor
at a certain calibrated/touch position deviates seriously from the intended
position screen gets touched position, so that you cannot even enter the
cracked 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.
4 The The foam in the 1. Remove the front cover, reinstall the
touchscreen front cover touchscreen, Ensure that the foam is in the out ring
has no presses the of the touchscreen and is not pressing the
response touchscreen. touchscreen.
when it is
clicked. The
cursor stays
in one corner
and cannot
move.
7-25
Hardware System
Error
No. Error type Troubleshooting
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;
3. If cable errors can be excluded, replace the
indicator board.
7-26
Hardware System
Error
No. Error type Troubleshooting
description
1 Motors The motor does 1. Check whether the problem is caused by main
not rotate. control board error (whether LCD may display
properly, if there is any power-related alarms); when
the main control board is with error, remove the
main control board error first;
2. Check whether the cable connecting a motor and
the main control board get loose or broken;
reconnect and replace the cable if necessary;
3. If cable errors can be excluded, replace the
motor.
position. necessary;
3. If cable errors can be excluded, replace the
photocoupler.
7-27
8 Mechanical System
8-1
Mechanical System
8-2
Mechanical System
8-3
Mechanical System
8-4
Mechanical System
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 maintenance spare part.
8-6
Mechanical System
8-7
Mechanical System
Maintenance
ID Material description Remarks
spare part ID
6 Insulation bar / /
7 Sampling assembly 115-025638-00 /
8 Shielding bottom plate welding piece / /
9 3-way Valve (Mindray) 801-3201-00003-00 /
10 WBC bath assembly 115-025645-00 /
11 RBC bath assembly 115-025644-00 /
12 Isolation chamber filter (injection molding) 043-000711-00 /
13 Isolation chamber 801-1805-00023-00 /
14 Isolation chamber holder / /
15 Shielding box / /
16 Right door / /
17 Reagent pre-heater assembly 115-049623-00 /
18 Waste pump assembly 115-025643-00 /
19 Vacuum chamber assembly 115-025641-00 /
20 Diluent temperature detection unit 115-015677-00 /
21 Air pump assembly 115-025715-00 /
22 2-way Valve (Mindray) 801-3201-00002-00 /
23 SMC 3-way valve(3106) 115-015967-00 /
24 Reagent detection assembly 115-025642-00 /
8-8
Mechanical System
8-9
Mechanical System
Maintenance spare
ID Material description Remarks
part ID
25 Power pack assembly 115-054722-00 /
26 Lower signal shielding cover / /
051-001714-00 /
27 3008 main control board PCBA 051-001714-02 / /
051-001714-03
28 Upper signal shielding cover / /
29 Left door assembly / /
30 TR60-H recorder 801-2800-00016-00 /
31 Reagent container / /
32 Lyse container cap assembly / /
33 Top cover / /
8-10
Mechanical System
8-11
Mechanical System
8-12
Mechanical System
Maintenance
ID Material description Remarks
spare part ID
GB/T9074.8 M3X8 with environment-friendly
color-zinc coating
Cross-recessed panhead self-drilling screw with no
7 cone point PT3X8, with environment-friendly / /
color-zinc coating
8 3008 keypad PCBA / /
8-13
Mechanical System
8-14
Mechanical System
8-15
Mechanical System
3 / /
O-ring 21.2X1.8 silicone A50
4 Pool cover of RBC 043-009250-00 /
Stainless cross recessed pan head
5 / /
screws GB/T818-2000 M3X6
6 pull mounting plate / /
7 chamber adjusting plate / /
8 RBC back pool / /
9 Front bath washer / /
10 Ruby Red Cell Counter
11 Back room electrode
8-16
Mechanical System
8-17
Mechanical System
8-18
Mechanical System
Flat-headed screwdriver
Tweezers
Nipper pliers
cutting nippers
8-19
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.
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.
Make sure all cables have been disconnected before disassembling the
components. Be careful not to break the cables or the connectors during
8-20
Mechanical System
disassembly.
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 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.
8-21
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).
8-22
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.
8-23
Mechanical System
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.
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.
8-24
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;
3. For the debugging and verification information of a certain component, refer to Chapter
11.
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.
8-25
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.
3. For the debugging and verification information of a certain component, refer to Chapter
11.
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.
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 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.
8-27
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.
3. Remove the tubes and cables connected to the liquid detection board and take out the
liquid detection board PCBA.
8-28
Mechanical System
Note:
During installation, the PCBA connector at the position should connect reagent tube, the
other connector should connect diluent tube.
Marked “L”
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.
8-29
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.
8-30
Mechanical System
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" →"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.
8-31
Mechanical System
8-32
Mechanical System
Installation:
Install the aspiration module 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
"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.
8-33
Mechanical System
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.
8-34
Mechanical System
Installation:
Install the sample probe in the reversed order of the disassembly steps.
For the debug method of sample probe position, refer to section 0.
Verification:
8-35
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:
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.
8-36
Mechanical System
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.
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.
8-37
Mechanical System
J25
J24
J26
8-38
Mechanical System
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.
8-39
Mechanical System
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.
8-40
Mechanical System
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 touch screen works properly.
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.
8-41
Mechanical System
Installation:
Install the touch screen in the reversed order of the disassembly steps.
Verification:
1. Check whether the cables connecting the touch screen and the control board are tightly
locked;
2. Check whether all the parts and components are properly installed and fixed;
3. Calibrate the touch screen;
4. Start the analyzer and check whether the touch screen works properly.
8-42
Mechanical System
3. As shown below, remove the 2 M3×8 screws, and take out the micro-switch assembly
from 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.
8-43
Mechanical System
4. Remove the 3 M3×8 screws and the tailored screw to disassemble the syringe (as
shown below).
Installation:
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.
8-44
Mechanical System
Installation:
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.
8-45
Mechanical System
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;
3. For the debugging and verification information of a certain component, refer to Chapter
11.
8-46
Mechanical System
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.
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;
2. Ensure the cables are correctly connected;
8-47
Mechanical System
Installation:
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. Try the print function and make sure the printer work normally.
8-48
Mechanical System
New label
location
PN : 051-001714-02 /
051-001714-03
8-49
Mechanical System
8.5.1.2 Solution
Maintenance scenario 1: new circuit board + new HGB assembly
1. Replace a new HGB circuit board.
2. Adjust the dial switch on the circuit board according to the following method.
3. Verify whether the adjustment has achieved satisfactory results referring to “Verification
after Replacement and Adjustment (Applicable to Maintenance Scenario 1&2)”.
3. Verify whether the adjustment has achieved satisfactory results referring to “Verification
after Replacement and Adjustment (Applicable to Maintenance Scenario 1&2”.
8-50
Mechanical System
NO
Finish
8-51
9 Troubleshooting
AD reference
Main 0x010001 voltage out of 051-001714-00 /
control 01 range [2.4, 051-001714-02 / Replace the main
board 2.6]V 051-001714-03 control board
error 0x010001 EEPROM data Master Board PCBA
02 incorrect
Constant 051-001714-00 /
0x010003 current source 051-001714-02 / Replace the main
01 voltage out of 051-001714-03 control board
range [47, 63]V Master Board PCBA
Power
+12V analog 115-025646-00 Check whether the
error 0x010003
voltage out of Power box assembly output of the power
02
range [11, 14]V 009-004354-00 DC board is normal using a
0x010003 -12V analog power cord multimeter. If the output
03 voltage out of Multimeter is abnormal, replace
9-1
Troubleshooting
115-025649-00
Diluent Pre_heating
assembly
Preheat
Preheat bath 051-001714-00 /
bath
0x010004 temperature 051-001714-02 /
temperatu
01 out of range 051-001714-03
re sensor
(0,70) ℃ Master Board PCBA Go to the status screen
error
009-004367-00 and check whether the
TempSensor Wire error exists;
Multimeter 2. Check the
115-015677-00 temperature sensor,
Diluent temperature connecting cable, and
detection unit main control board in
Diluent Diluent 051-001714-00 / turn.
temperatu 0x010004 temperature 051-001714-02 /
re sensor 02 out of range 051-001714-03
error (0,70) ℃ Master Board PCBA
009-004367-00
TempSensor Wire
Multimeter
9-2
Troubleshooting
0x02nn01 051-001714-02 /
Other error.
03 051-001714-03
Master Board PCBA
Lubricating grease
9-3
Troubleshooting
0x02nn0 051-001714-02 /
Other error.
303 051-001714-03
Master Board PCBA
Lubricating grease
9-4
Troubleshooting
115-025649-00
Preheat Diluent heating
Preheat bath Check the diluent
bath assembly
0x050001 temperature heating assembly and
temperatu 051-001714-00 /
01 higher than main control board in
re is too 051-001714-02 /
45℃ turn
high 051-001714-03
Master Board PCBA
115-025649-00
Diluent heating
Preheat Preheat bath assembly Check the connecting
bath temperature is 051-001714-00 / cable of the heater,
0x050001
temperatu 2.0 ℃ lower 051-001714-02 / diluent heating
02
re is too than the target 051-001714-03 assembly, and main
low temperature Master Board PCBA control board in turn
009-004359-00 Heat
Driver Wire
9-5
Troubleshooting
115-025643-00
1. Go to the Temp &
Waste pump
Pressure screen, and
assembly
check whether the error
115-025641-00
exists;
Vacuum/Pressure
2. Check the waste
Pressure out of Chamber
Vacuum pump and the
0x060001 the range 801-3201-00003-00
pressure connecting cables of
01 specified by 3-way Valve
abnormal the valves and pump in
the sequence (Mindray)
turn.
801-3201-00002-00
3. Check the vacuum
2-way Valve
chamber, valves and
(Mindray)
related tubing in turn for
009-004358-00
leakage.
Valve and pump wire
For single-bath
115-025645-00 WBC
Clogging( 0x070001 WBC aperture analyzers
bath assembly
WBC) 01 voltage high (BC-10/11/10e/20/21):
PROBE CLEANSER
The normal aperture
voltage range is
7.5V-18V (for both
WBC and RBC count)
9-6
Troubleshooting
6.5V-14.5V
1. Check the
instrument, including
whether the earthing
screws are normal, and
whether the shielding
WBC
Detect strong box is open;
channel
0x070006 interfering 2. Search for external
signal /
01 signal in WBC source of interference,
interferenc
channel e.g. whether the
e
external power supply
is stable, and whether
there is any object
nearby producing
strong interference.
9-7
Troubleshooting
box is open;
2. Search for external
source of interference,
e.g. whether the
external power supply
is stable, and whether
there is any object
nearby producing
strong interference.
9-8
Troubleshooting
clean.
9-9
Troubleshooting
Sys. Abnormal
0x070007
config system / Restart the analyzer
04
abn. configuration
No paper
0x090001 No paper or No paper or paper Check whether there is
or paper
01 paper jam jam no paper or paper jam
jam
9-10
Troubleshooting
115-025651-00 LCD
assembly (8.4″)
Screen 115-039856-00 LCD
flickering assembly(8.4")
/ / See section 7.9.2
or 009-007651-00
blackout LCD‘s wire
115-025652-00 LCD
assembly (10.4″)
9-11
Troubleshooting
009-007650-00
LCD screen
connecting wire
051-001714-00 /
051-001714-02 /
051-001714-03
Master Board PCBA
Multimeter
021-000271-00
Touch panel resistive
8.4inch 4-wires
009-004655-00
Small touch panel
wire
Screen 801-3110-00184-00
used / / Touch screen, See section 7.9.4
improperly 10.4″
009-004366-00
Touch panel
connection wire
051-000881-00 6301
Touch screen control
board PCBA
9-12
10 Adjustment
10-1
Adjustment
Note:
1. In Figure 10-1, before tapping "Initial position" button, all other buttons are disabled.
Adjust the screws on the left Only after you tap "Initialize", the other three buttons will be enabled. Only after you tap
WBC bath
and right positions
"WBC Bath"/"RBC Bath", the "Middle position" and "Down position" buttons will be
enabled.
10-2
Adjustment
Figure 10-4
Fixture 3008-J02 Probe wipe positioner
Point of Criteria of
Control Control
Steps Action
For dual-bath analyzers, tap "Initial Adjust the 1. The
position" > "RBC Bath" to make the position of the sample
sample probe stays above the RBC bath sample probe in probe
and adjust its position in relation to the relation to the should
RBC bath according to steps 1.2-1.4. RBC bath. not
For single-bath analyzers, skip this step. contact
The sample probe must contact the bottom of the fixing the bath
1.5
device. assemb
ly.
2. The
screws
should
be well
fixed.
Tap "Height-fixed pos." to make the Adjust the The sample
sample probe stays above the WBC bath. position of the probe must
Use the probe wipe positioner to adjust the sample probe in contact the
1.6 position of the sample probe in relation to relation to the probe wipe
the probe wipe as shown in Figure 10-4 probe wipe. positioner.
and Figure 10-5. The torsion for the
screws is 3.2 to 4.5 kgN.
10-3
Adjustment
Figure 10-5 Tap "Initial position", and then randomly Check the The sample
tap "WBC Bath", "Aspiration Pos." and position of the probe should not
1.7
"RBC Bath" to check whether the sample sample probe scratch other
probe scratches other components. components.
Note:
1. Perform step 1.5 for only dual-bath analyzers. The single-bath analyzer does not have
RBC bath, therefore does not require this step.
2. Before positioning the probe wipe, be sure to tap "Height-fixed pos." to make the sample
Fasten the
panhead screws probe stays above the WBC bath because the rotary motor changes the sample probe
on the fixing height in the vertical position. Do not perform height fixing on other positions. It is
device
forbidden to click "WBC Bath" directly.
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 Aperture voltage normal;
self-test screen shown in Figure 10-6. Tap voltage 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
Adjustment
Tap "Yes" to save the settings and switch to the corresponding screen.
Tap "No" to switch to the corresponding screen without saving the settings.
10-7
11 Debugging and Validation After
Servicing
Service
Component Name Adjustment Requirement Validation
Material ID
Master Board 051-001714-00 / 1. Back up the configuration Version information correct
PCBA
051-001714-02 / data as instructed by the
051-001714-03 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 3101-20-68304
block of injector
special bolt 3 041-005167-00
250ul syringe (with 115-027479-00
nozzle)
Sampling 115-025638-00 1. Make sure that there is Check the repeatability
Assembly
no bent-over of tubes, and
11-1
Debugging and Validation After Servicing
11-2
Debugging and Validation After Servicing
11-3
Debugging and Validation After Servicing
11-4
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 023-001056-00 1. Back up the data before /
Class10
replacing the SD card (if
possible);
2. Restore the configuration
data.
11-5
12 Service BOM
ID Name
115-025638-00 Sampling assembly
021-000271-00 touchpanel resistive 8.4inch 4-wires
023-000866-00 Handheld Barcode Scanner
023-001524-00 SDcard 8GB Class10
024-001032-00 FAN 12Vdc 40*40*10MM 4.1cfm 25dB 300mm
041-020880-00 Swab adjuster
042-005948-00 top signal shield
042-005949-00 bottom signal shield
042-011528-00 shielding box
042-011531-00 key mounting plate
042-020906-00 right door(3008)
042-020086-00 right door (3011, 3012)
042-011538-00 top cover
042-020088-00 top cover (3011, 3012)
043-000711-00 filter
043-000829-00 reagent detection tube
043-007675-00 nel assembled(BC-20S)
043-005463-00 panel assembled(BC-20S)
043-005464-00 panel assembled(BC-30S)
043-005810-00 [Aspirate] key(BC-20S)
043-008994-00 key(BC-30S)
043-005587-00 Front Cover(10inches for bid)
043-007674-00 Front Cover(8inches for bid)
043-008298-00 front cover (BC-10)
043-008299-00 front cover (BC-20)
043-008406-00 front cover (BC-11)
043-008407-00 front cover (BC-21)
043-008300-00 front cover (BC-30)
043-008408-00 front cover (BC-31)
043-009251-00 front cover (BC-30e)
043-010034-00 front cover (BC-10e)
047-005535-00 LONG GASKET, IPM8 TOUCH SREEN
047-005536-00 SHORT GASKET, IPM8 TOUCH SREEN
047-016362-00 10INCH TOUCHSCREEN LONG GASKET
047-016363-00 10INCH TOUCHSCREEN SHORT GASKET
051-001621-00 Liquid detect board PCBA
051-001714-00 Master Board PCBA
051-001714-02 Master Board PCBA
051-001714-03 Master Board PCBA
051-001857-00 3008 indicate board PCBA
051-001319-00 3107 Power Source PCBA
051-002708-00 3206 Power Board PCBA for Burning
12-1
Service BOM
12-2
Service BOM
12-3
13 Appendices
A. Fluidic diagram
As shown in the following fluidic diagram, the red line indicates the lyse routing in the fluidic.
1. For BC-30s/31s/20s/21s: The lyse is aspirated from the lyse bottle by the 10ml syringe, passes through tubes T48, T54, T47, and valve SV07 and enters
tube T6 for storage. Then, the lyse is pushed forwarded by the 10ml syringe and goes through T6, SV07, T7, and T8 to WBC bath to react.
2. For BC-30/31/30e: The lyse is aspirated from the lyse bottle by the 10ml syringe, passes through tubes T48, T54, and valve SV07, and enters tube T6 for
storage. Then, the lyse is pushed forwarded by the 10ml syringe and goes through T6, SV07, T7, and T8 to WBC bath to react.
3. For BC-20/21/10/11/10e: The lyse is aspirated from the lyse bottle by both the 10ml syringe and 250ul syringe, passes through tubes T15, T14, and valve
SV07, and enters tube T12 for storage. Then, the lyse is pushed forwarded by the 10ml syringe and 250ul syringe through T12, SV07, T19, and T20 to
WBC bath to react.
A-1
Fluidic Diagram
Reagent
detectio
n C23
T47 T7
SV07
T54
T11 C4
T13
T23
C5
T8
T6
T58
SV05 WBC RBC
C22
C2
T24
T5
T19
T48
Preheat
J3-T34-
J1-T33-
bath
T25
J9-T52-J10
J4
J2
chamber
Isolation
C13 C7
chamber2
C6
T10
Isolation
T14
C14 T35 T36
J12-T51-P1
T4
1
Lyse bottle
T49 T49
T20
T3
T61
T38
T37
C25 SV04
C26
T56
T57
C3 SPB SV09 SV08
SV06
T26
Temperateu
T12
C15
re sensor
T17
T39
T43
T2
T42
T40
T21
T9 T16 C10 C11
C8 C9
J5-T44-
J7-T45-
T22
T27
T41
J6
J8
SV03 T28
SV01
C24
T55
T15
T29
T1
C12
C21
T46
VC
T53
C17
C18 Transducer GP
T32
containe
Diluent
WASTE
T50
T30
Waste LP
r
C20 C19
SR container T31
A-2
Fluidic Diagram
T54
T7
T10
SV07
T23
T8
T6
SV05 WBC RBC
T58
C22
C2
T24
T5
T19
T48
J3-T34-J4
J1-T33-J2
T25
J9-T52-J10
C13 C6 C7
T35 T36
J11-T51-P1
T4
C14
chamber 1
chamber
Isolation
Isolation
Lyse bottle
T49 T49
2
SV02 T59 T60
C1
T20
T3
T37
T38
T61
C25 SV04 C26
T56
T57
C3 SPB SV09 SV08
SV06
T26
T12
C15
Temperature
T43
T17
T40
sensor
T42
T2
T9 C10 C11
T16
T21
T39
C8 C9
J5-T44-J6
J7-T45-J8
T22
T27
T41
SV01 SV03 T28
T55 C24
T15
T29
T1
C12
C21
T46
VC
T53
C17
Transducer GP
T32
C18
container
WASTE
Diluent
T50
T30
Waste LP
container C20 C19
SR T31
A-3
Fluidic Diagram
C4
T14
C6
T12
T19 PS
C25 V07 V04 T27
T17
T47 T20 T23 C13 C14
T26
C5 T21 C12
Prehe
T50
at bath
T25
T24 C17
T48 WBC T29
T15 V06 T46 T49
V05 T33
T11 C24
T9 VAC
T10
TS
T18
T28 PUMP_PRES
J1-T4-J2 T22 S
J5-T34-J6
T16
V01 V02
J7-T6-P1
T30
T35
Isolation T37
C18 C15
T3 chamber C2
T1 T7
T36 T51 0 T45 C16
T32 J3-T31-J4
T2 V09
SPB
C8 C10
C11
ASP(250uL)
DIL 10mL
C9
C19
T44
SR
Lyse T43
T8 T38
Probe
containe
wipe
Diluent
bottle
V08
r
T42
T39
C21 C22 C23 Waste
T40 T41
container
PUMP_WASTE
A-4
B. Connection and Tube
List of Materials in the Fluidic Diagram for BC-30s/31s/20s/21s
Name in the
No. Material Type Material ID Unit Quantity
Diagram
1 Syringe SR 115-015652-00 EA 1
2 WBC bath WBC 115-025645-00 EA 1
3 RBC bath RBC 115-025644-00 EA 1
Vacuum
4 VC 115-015673-00 EA 1
chamber
5 Liquid pump LP 3001-10-07252 EA 1
6 Gas pump GP 082-002497-00 EA 1
7 Sample probe SPB 3001-10-07059 EA 1
8 Probe wipe Probe wipe 3001-30-06957 EA 1
Isolation Isolation
9 115-002439-00 EA 1
chamber chamber 1
Isolation Isolation
10 3003-20-34949 EA 1
chamber chamber 2
Preheating
11 Heating bath 115-009948-00 EA 1
bath
Temperature
12 Sensor 115-015677-00 EA 1
sensor
Electromagnetic
13 SV1 115-010088-00 EA 1
valve
Electromagnetic
14 SV2 115-015967-00 EA 1
valve
Electromagnetic
15 SV3 115-010089-00 EA 1
valve
Electromagnetic
16 SV4 115-010089-00 EA 1
valve
Electromagnetic
17 SV5 115-010088-00 EA 1
valve
Electromagnetic
18 SV6 115-010088-00 EA 1
valve
Electromagnetic
19 SV7 115-010088-00 EA 1
valve
Electromagnetic
20 SV8 115-010088-00 EA 1
valve
Electromagnetic
21 SV9 115-010088-00 EA 1
valve
22
23
24
B-1
Connection and Tube
B-2
Connection and Tube
Name in the
No. Material Type Material ID Unit Quantity
Diagram
B-3
Connection and Tube
Material
No. Material Ty pe Material ID Unit Quantity
Ty pe
B-5
Connection and Tube
Name in the
No. Material Type Material ID Unit Quantity
Diagram
1 Syringe SR 115-015652-00 EA 1
2 WBC bath WBC 115-025645-00 EA 1
3 RBC bath RBC 115-025644-00 EA 1
Vacuum
4 VC 115-015673-00 EA 1
chamber
5 Liquid pump LP 3001-10-07252 EA 1
6 Gas pump GP 082-002497-00 EA 1
7 Sample probe SPB 3001-10-07059 EA 1
8 Probe wipe Probe wipe 3001-30-06957 EA 1
Isolation Isolation
9 115-002439-00 EA 1
chamber chamber 1
Isolation Isolation
10 3003-20-34949 EA 1
chamber chamber 2
Preheating
11 Heating bath 115-009948-00 EA 1
bath
Temperature
12 Sensor 115-015677-00 EA 1
sensor
Electromagnetic
13 SV1 115-010088-00 EA 1
valve
Electromagnetic
14 SV2 115-015967-00 EA 1
valve
Electromagnetic
15 SV3 115-010089-00 EA 1
valve
Electromagnetic
16 SV4 115-010089-00 EA 1
valve
Electromagnetic
17 SV5 115-010088-00 EA 1
valve
Electromagnetic
18 SV6 115-010088-00 EA 1
valve
Electromagnetic
19 SV7 115-010088-00 EA 1
valve
Electromagnetic
20 SV8 115-010088-00 EA 1
valve
Electromagnetic
21 SV9 115-010088-00 EA 1
valve
22
23
24
B-6
Connection and Tube
B-7
Connection and Tube
Name in
No. Material Type the Material ID Unit Quantity
Diagram
55 Rubber tube T35 M6G-020006--- mm 20
56 Rubber tube T36 M6G-020006--- mm 20
57 Rubber tube T37 M90-100071--- mm 80
58 Rubber tube T38 M90-100071--- mm 140
59 Rubber tube T39 M90-100071--- mm 70
60 Rubber tube T40 M90-100071--- mm 30
61 Rubber tube T41 M90-100071--- mm 130
62 Rubber tube T42 M90-100071--- mm 140
63 Rubber tube T43 M90-100071--- mm 90
64 Rubber tube T44 082-000109-00 mm 220
65 Rubber tube T45 082-000109-00 mm 380
66 Rubber tube T46 M6G-020006--- mm 80
67 Rubber tube T48 3001-10-07069 mm 300
68 Rubber tube T49 A21-000002--- mm 180
69 Rubber tube T50 082-000314-00 mm 300
70 Rubber tube T51 082-000422-00 mm 400
71 Rubber tube T52 M90-100031--- mm 700
72 Rubber tube T53 3001-10-07069 mm 40
73 Rubber tube T54 3001-10-07069 mm 600
74 Rubber tube T55 M90-100071--- mm 45
75 Transfer tube T56 M6G-020006--- mm 15
76 Transfer tube T57 M6G-020006--- mm 15
77 Transfer tube J1 M90-100071--- mm 25
78 Transfer tube J2 M6G-020006--- mm 25
79 Transfer tube J3 M90-100071--- mm 25
80 Transfer tube J4 M6G-020006--- mm 25
81 Transfer tube J5 082-000710-00 mm 20
82 Transfer tube J6 082-000710-00 mm 20
83 Transfer tube J7 082-000710-00 mm 20
84 Transfer tube J8 082-000710-00 mm 20
B-8
Connection and Tube
Name in the
No. Material Type Material ID Unit Quantity
Diagram
85 Transfer tube J9 082-000055-00 mm 20
86 Transfer tube J10 0030-20-13339 EA 1
87 Transfer tube J11 082-000710-00 mm 20
88 Silicone Tube P1 082-000108-00 mm 200
89 Tube connector C1 M90-100066--- EA 1
90 Tube connector C2 M90-100027--- EA 1
91 Tube connector C3 M90-100027--- EA 1
92 Tube connector C6 M90-100026--- EA 1
93 Tube connector C7 M90-100026--- EA 1
94 Tube connector C8 M90-100027--- EA 1
95 Tube connector C9 M90-100028--- EA 1
96 Tube connector C10 M90-100028-01 EA 1
97 Tube connector C11 M90-100028-01 EA 1
98 Tube connector C12 M90-100028-03 EA 1
99 Tube connector C13 M90-100024--- EA 1
100 Tube connector C14 M90-100009--- EA 1
101 Tube connector C15 M6Q-030111--- EA 1
102 Tube connector C16 M90-100009--- EA 1
103 Tube connector C17 M6Q-030111--- EA 1
104 Tube connector C18 M90-100009--- EA 1
105 Tube connector C21 M90-100028-01 EA 1
106 Tube connector C22 043-000892-00 EA 1
107 Tube connector C24 M90-100100--- EA 1
108 Tube connector C25 M90-100027--- EA 1
109 Tube connector C26 M90-100027--- EA 1
110 Rubber tube T58 3001-10-07069 mm 40
111 Rubber tube T59 M90-100071--- mm 120
112 Rubber tube T60 M90-100071--- mm 60
113 Rubber tube T61 3001-10-07069 mm 240
B-9
Connection and Tube
B-10
Connection and Tube
Name in
Material
No. the Material ID Unit Quantity
Type
Diagram
31 Rubber tube T33 M6G-020006--- mm 20
32 Rubber tube T34 M90-100031--- mm 160
33 Rubber tube T35 M6G-020006--- mm 20
34 Rubber tube T36 M90-100071--- mm 120
35 Rubber tube T37 082-000314-00 mm 40
36 Rubber tube T38 M90-100071--- mm 250
37 Rubber tube T39 M90-100071--- mm 260
38 Rubber tube T40 082-000314-00 mm 30
39 Rubber tube T41 082-000314-00 mm 120
40 Rubber tube T42 M6G-020055--- mm 1500
41 Rubber tube T43 A21-000002--- mm 180
42 Rubber tube T44 082-000314-00 mm 300
43 Rubber tube T45 M6G-020006--- mm 15
44 Rubber tube T46 082-000314-00 mm 20
45 Rubber tube T47 082-000314-00 mm 20
46 Rubber tube T48 082-000108-00 mm 20
47 Rubber tube T49 3001-10-07069 mm 240
48 Rubber tube T50 3001-10-07069 mm 240
49 Rubber tube T51 M90-100071--- mm 80
50 Rubber tube J1 082-000055-00 mm 20
51 Rubber tube J2 0030-20-13339 EA 1
52 Rubber tube J3 082-000710-00 mm 20
53 Rubber tube J4 082-000710-00 mm 20
54 Rubber tube J5 M90-100071--- mm 25
55 Rubber tube J6 M6G-020006--- mm 25
56 Rubber tube J7 082-000710-00 mm 20
57 Rubber tube P1 082-000108-00 mm 200
B-11
Connection and Tube
Name in
Material
No. the Material ID Unit Quantity
Type
Diagram
58 Transfer tube C4 043-000892-00 EA 1
59 Transfer tube C5 M90-100027--- EA 1
60 Transfer tube C6 M6Q-030111--- EA 1
61 Transfer tube C7 M90-100009--- EA 1
62 Transfer tube C8 082-001140-00 EA 1
63 Transfer tube C9 082-001141-00 EA 1
64 Transfer tube C10 M6Q-030111--- EA 1
65 Transfer tube C11 M90-100009--- EA 1
66 Transfer tube C12 M90-100027--- EA 1
67 Transfer tube C13 M90-100100--- EA 1
68 Transfer tube C14 M90-100028-01 EA 1
69 Transfer tube C15 M90-100028-01 EA 1
70 Transfer tube C16 M90-100028-01 EA 1
71 Transfer tube C17 M90-100026-- EA 1
72 Transfer tube C18 M90-100026-- EA 1
73 Transfer tube C19 M90-100027--- EA 1
74 Transfer tube C20 M90-100027--- EA 1
75 Transfer tube C21 M90-100027--- EA 1
76 Transfer tube C22 M6G-030111--- EA 1
77 Transfer tube C23 M90-100009--- EA 1
78 Transfer tube C24 M90-100066--- EA 1
79 Transfer tube C25 M90-100027--- EA 1
B-12
Connection and Tube
B-13
C. Hardware block diagram
Aspiration Syringe
Valves & Liquid
Assembly Assembly Preheating
Pumps Detection Floater
MotorX2 MotorX1 X1
X16 X2
SensorX3 SensorX1
Grounding 009-004358-00
009-004359-00
009-004357-00
Power 009-004354-00
009-004355-00
009-004360-00 009-004361-00
Board
009-004357-00
009-004356-00
Aspirate
009-004361-00
Key
Power Power Liquid Floater&
Motor Sensor
Source Driving Detection Aspiration
009-004362-00
Recorder
Recorder (Side
Door)
USB USB
009-004364-00
009-004471-00
LCD
Front
LVDS Cover
Backlight
Main Control
LCD Touch
Screen
Touch (Transfer Earthing
Digital Screen Connection)
Power 009-004366-00
Board
009-004655-00
Preheating
US Bth
B
Vacuum
US 009-004367-00 Chamber
B Atmospheric
HGB Temperature
051-001714-00 Pressure Diluent
009-004368-00
LA
N
009-004369-00
RBC RBC
Bath
Shielding
009-004370-00 Box
Analog WBC
Power WBC
Bath
C-1
D. Cables and Wires
Connecting
Socket on
Material ID Name the Main Connection
Control
Board
Syringe Motor Connects 115-025639-00 Syringe
009-004355-00
Wire J8 assembly
Connects 115-025638-00 Sampling
Sample Motor assembly
009-004356-00
Wire UP: connects upper motor
J7 DOWN: connects down motor
Connects 115-025638-00 Sampling
assembly
UP: connects upper photosensor of
sampling assembly
Photosensor
009-004357-00 LEFT: connects left photosensor of
Wire for Motor
sampling assembly
RIGHT: connects right photosensor of
sampling assembly
J12 INJ: connects syringe photosensor
V1~V10: connects the valve
corresponding to the division plate
printing
Valve and Pump
009-004358-00 GAS: connects 115-025715-00 air pump
Wire
assembly
WAS: connects 115-025643-00 waste
J9 pump assembly
Connects 115-025649-00 Reagent
pre-heater assembly
009-004359-00 Heat Driver Wire
HT: connects the heater
J11 TS: connects the Thermal protector
Reagent: connects the reagent pipes
Diluent: connects the diluent pipes
Note: Only models BC-30s/31s/20s/21s
Liquid Detect
009-004360-00 are equipped with the 009-004360-00
Board Wire
Liquid Detect Board Wire, other models
(BC-10/11/10e/20/21/30/31/30e) are not
J14 equipped with this wire.
Float and The white connector connects the
009-004361-00 Aspirate Key aspirate key
Wire J15 The black connector connects the float
Connects 115-002795-00 TR60-H
009-004362-00 Recorder wire
J16 recorder
Indicate board Connects 051-001857-00 3008 indicator
009-004363-00
wire J19 board PCBA
009-004367-00 TempSensor J27 HEAT-TEMP: detects preheater
D-1
Cables and Wires
D-2
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 / × √ √
Reproducibilit
Performance / × × √
y
Carryover / × × √
Date/Time Setup √ √ √
Print setup √ √ √
Communication √ √ √
System Setup
Shortcut Code
× √ √
Setup
Lab Info Setup × √ √
Access
/ × √ √
Management
Auxiliary
Setup / √ √ √
Setup
Reference Unit
× √ √
Setting Setup
Parameters Reference Range
× √ √
Setup
Maintenance / √ √ √
Reagent
/ √ √ √
Setup
Gain Setup / × √ √
Maintenance / √ √ √
Self-Test / √ √ √
Sample Probe
/ × √ √
Debug
Gain
/ × √ √
Service Calibration
Temperature
/ × √ √
calibration
Screen Cal. / √ √ √
Advanced
/ × √ √
Toolbox
E-1
Menu Tree
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-2
F. Appendix Table
Product Model SN
Inspection
No. Description Requirement Result Conclusion
Item
See the
Electrical Safe and reliable
1 diagrams in the □OK □NG □PASS □FAIL
connections earthing
appendices
Beeping Having beeping
2 / □OK □NG □PASS □FAIL
alarm 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
Mechanical Sample probe
of "Adjusting
5 position position in relation □OK □NG □PASS □FAIL
Mechanical
validation to the WBC bath
Positions"
See the section
Mechanical Sample probe
of "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
liquid suspended at No suspended
□OK □NG □PASS □FAIL
the sample probe liquid
tip
Sample probe is
under the surface of Sample probe
the liquid and does lower position □OK □NG □PASS □FAIL
not contact the normal
Counting bottom of the bath
7
Channel Test Whether there are
There are
bubbles when
bubbles when □OK □NG □PASS □FAIL
making bubbles in
making bubbles
the WBC bath
Whether there are
There are
bubbles when
bubbles when □OK □NG □PASS □FAIL
making bubbles in
making bubbles
the RBC bath
In the process of
making bubbles in No overflow or
□OK □NG □PASS □FAIL
the WBC bath, contact
whether there is
F-1
Appendix Table
overflow, and
whether the
bubbles contact the
inlet tube
In the process of
making bubbles in
the RBC bath,
whether there is No overflow or
□OK □NG □PASS □FAIL
overflow, and contact
whether the
bubbles contact the
inlet tube
Whether the WBC
Emptied
bath is emptied □OK □NG □PASS □FAIL
normally
normally
Whether the RBC
Emptied
bath is emptied □OK □NG □PASS □FAIL
normally
normally
Bath shielding box Screws are well
□OK □NG □PASS □FAIL
installation fixed
No interference
Sample probe
when the sample □OK □NG □PASS □FAIL
action
probe is in action
No interference
between the
Sample probe
sample probe □OK □NG □PASS □FAIL
tubing
tubing and other
structures
Perform Refer to the
Instrument
8 maintenance and operator's □OK □NG □PASS □FAIL
maintenance
cleaning manual
WBC ≤0.20×109/L □PASS □FAIL
RBC ≤0.02×1012/L □PASS □FAIL
Background
9 HGB ≤1g/L □PASS □FAIL
test
HCT ≤0.50% □PASS □FAIL
PLT ≤5×109/L □PASS □FAIL
Print analysis Able to print
10 Recorder □OK □NG □PASS □FAIL
results properly
No error
11 Shutdown Shutdown process message or □OK □NG □PASS □FAIL
alarm
F-2
P/N: 046-011449-00(7.0)