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BC-3600 plus Service Training

1.

BC-3600 plus Service Training
Hematology Global Technical Support Department
service@mindray.com
Version: 2.0
NO.:MXQ-11014-BC-3600
© 2011 Mindray Confidential

Contents
Principle
1.1 Basic knowledge
1.2 Principle
BC-3600
2.1 Installation
2.2 Operation
2.3 Liquid System
2.4 Hardware
2.5 System Structure
2.6 Troubleshooting
2.7 Maintenance
2
© 2011 Mindray Confidential

3.

1. Principle
1.1 Basic Knowledge
1.2 Principle
3
© 2011 Mindray Confidential

4.

1.1 Basic Knowledge
Blood
Leukocyte
Erythrocyte
Platelet
Blood consists of 40-50% blood cell and 50-60% plasma.
Three main parts of blood cell: red blood cell, white blood cell and
platelet.
4
Blood Cell
© 2011 Mindray Confidential

5.

1.1 Basic Knowledge
Blood
Blood Cell
Leukocyte
Erythrocyte
Platelet
There are three kinds of blood cells.
Leukocyte
Size:
30-400fl
9
Amount: 4-10X10 /L
5
© 2011 Mindray Confidential
Erythrocyte
Platelet
30-150fl
12
3.5-5.5X10 /L
2-25fl
9
100-300X10 /L

6.

1.1 Basic Knowledge
Blood Cell
Blood
WBC
Defend the body
against infectious
disease and foreign
materials
6
© 2011 Mindray Confidential
Leukocyte
Granulocyte
Erythrocyte
Platelet

7.

1.1 Basic Knowledge
Blood
Lymphocyte
7
© 2011 Mindray Confidential
Blood Cell
Leukocyte
Mid-sized Cell
Erythrocyte
Platelet
Neutrophilic Granulocyte

8.

1.1 Basic Knowledge
Blood
Blood Cell
Leukocyte
Erythrocyte
Platelet
The function of RBC is almost completed by hemoglobin (HGB).
Transport oxygen and carbon dioxide
8
© 2011 Mindray Confidential

9.

1.1 Basic Knowledge
Blood
Blood Cell
Leukocyte
Erythrocyte
Coagulation or clotting
9
© 2011 Mindray Confidential
Platelet

10.

1.2 Principle
10
© 2011 Mindray Confidential

11.

1.2 Principle
Electrical Impedance
Method
Volumetric Metering
Colorimetric Method
Reagents
WBC, RBC and PLT are counted and sorted by the Electrical Impedance Method.
This method is based on the measurement of changes in electrical impedance
produced by a particle passing through an aperture.
11
© 2011 Mindray Confidential

12.

1.2 Principle
Electrical Impedance
Method
12
© 2011 Mindray Confidential
Volumetric Metering
Colorimetric Method
Reagents

13.

1.2 Principle
1.2 Principle
Electrical Impedance
Method
Volumetric Metering
Colorimetric Method
Reagents
The amplitude of each pulse is proportional to the size of each blood cell.
13
© 2011 Mindray Confidential

14.

1.2 Principle
Electrical Impedance
Method
Pulse Graph
Volumetric Metering
Colorimetric Method
Reagents
1、blood cell of Same size, go through the
aperture by constant distribution.
2、blood cell of Same size, go through the
aperture by variable distribution.
3、blood cell of different size, go through the
aperture by variable distribution.
14
© 2011 Mindray Confidential

15.

1.2 Principle
1.2 Principle
Electrical Impedance
Method
15
© 2011 Mindray Confidential
Volumetric Metering
Colorimetric Method
Reagents

16.

1.2 Principle
Electrical Impedance
Method
Volumetric Metering
From Pulse Graph to Histogram
16
© 2011 Mindray Confidential
Colorimetric Method
Reagents

17.

1.2 Principle
Electrical Impedance
Method
Volumetric Metering
From Pulse Graph to Histogram
17
© 2011 Mindray Confidential
Colorimetric Method
Reagents

18.

1.2 Principle
Electrical Impedance
Method
Volumetric Metering
Colorimetric Method
Reagents
This analyzer uses a volumetric metering unit to control the count cycle and to
ensure that a precise volume of sample is analyzed.
Upper sensor
Upper sensor
Lower sensor
Lower sensor
1 Empty when start
Upper sensor
Upper sensor
Lower sensor
Lower sensor
3 Counting start when the
liquid surface pass the upper
sensor.
18
© 2011 Mindray Confidential
2 Liquid surface fall down through the
volumeritc tube
4 Counting end when the liquid
surface pass the lower sensor

19.

1.2 Principle
Electrical Impedance
Method
Volumetric Metering
Colorimetric Method
Reagents
HGB is determined by the colorimetric method.
Lyse will release HGB when RBC was broken down and react with HGB to
generate a mixture for HGB measurement.
The mixture has the biggest absorbance at 540nm.
I0
It
L
19
© 2011 Mindray Confidential

20.

1.2 Principle
Electrical Impedance
Method
20
Volumetric Metering
Light
source
Absorbing
container
LED light
Bath
© 2011 Mindray Confidential
Colorimetric Method
Detector
Signal
processing
Display
Photosensor
Reagents

21.

1.2 Principle
Electrical Impedance
Method
Volumetric Metering
Colorimetric Method
Reagents
Reagents are one part of the system.
Lyse
Break down RBC;
Release HGB and react with HGB to generate a mixture for HGB
measurement;
Help the differential of WBC.
Diluent
Dilute the blood sample;
Provide a conductive environment for counting and an environment
which is similar to the plasma to maintain the size of blood cell;
Clean the tube and bath.
21
© 2011 Mindray Confidential

22.

1.2 Principle
Electrical Impedance
Method
Volumetric Metering
Colorimetric Method
Reagents
Rinse
Clean the bath and metering tube.
E-Z cleanser
An enzyme-based cleaning solution used to clean the tube and
bath.
Probe cleanser
An alkaline cleaning solution used to clean the tube and bath.
22
© 2011 Mindray Confidential

23.

1.2 Principle
Parameters
BC-3600 can give out 21 parameters and 3 histograms:
WBC
RBC
PLT
Lymph#
HGB
MPV
Mid#
HCT
PDW
Gran#
MCV
PCT
Lymph%
MCH
P-LCC
Mid%
MCHC
P-LCR
Gran%
RDW-CV
RDW-SD
23
© 2011 Mindray Confidential

24.

2.1 Installation
2.1.1 Installation Requirements
2.1.2 Interface
2.1.3 Installation Procedures
24
© 2011 Mindray Confidential

25.

2.1.1 Installation Requirements
Environment
Space
Power
Operating temperature: 15 ℃ to 30 ℃.
Relative humidity: 30% to 85%.
Atmospheric pressure: 70 kPa to 110 kPa. (height above sea level
0~3km)
free as possible from dust, mechanical vibrations, loud noises, and
electrical interference.
Do not place near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.
Do not place in direct sunlight or in front of a source of heat or drafts.
25
© 2011 Mindray Confidential

26.

2.1.1 Installation Requirements
Environment
Space
Power
At least 28 cm on each side, which is the preferred access to
perform service procedures.
At least 10 cm behind for cabling and ventilation.
There is enough room on or below the countertop to accommodate
the diluent, rinse and waste containers.
(reagents bottle better be the same level of the machine).
26
© 2011 Mindray Confidential

27.

2.1.1 Installation Requirements
Environment
Space
Power
voltage: 100 VAC - 240 VAC; fluctuation should be in the range of
±10%.
frequency: 50/60±1 Hz;
fuse: 250V T4A
Maximum power consumption 180 watts;
Grounding must be provided in accordance with all applicable legal
requirements for medically used electrical equipment.
27
© 2011 Mindray Confidential

28.

2.1.2 Interface
Front panel (O.V)
1, Touch screen
2, Power indicator
3, Sample probe
4, Aspirate key
5, USB interface
6, Recorder
28
© 2011 Mindray Confidential

29.

2.1.2 Interface
Front panel (C.T)
1, Touch screen
2, Power indicator
3, Sample compartment door
4, USB interface
5, Recorder
29
© 2011 Mindray Confidential

30.

Adaptors used in closed tube
Prediluted mode
30
© 2011 Mindray Confidential
Whole blood mode

31.

2.1.2 Interface
Rear panel
1, USB interface 1
2, USB interface 2 (2 ports)
3, Network interface
4, Serial port
5, Power
6, Waste
7, Rinse
8, Diluent
31
© 2011 Mindray Confidential

32.

2.1.3 Installation Guide
32
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33.

2.1.3 Installation Guide
33
© 2011 Mindray Confidential

34.

2.1.3 Installation Procedures
Release the sample probe
1, Open the front panel;
2, Removal the cable tie;
3, Close the front panel;
34
© 2011 Mindray Confidential
Step3
Step4

35.

2.1.3 Installation Procedures
Step1
Install Recorder Paper
Step4
Thermal side up
35
© 2011 Mindray Confidential

36.

2.1.3 Installation Procedures
Step1
36
© 2011 Mindray Confidential
Step3
Performance Validation

37.

2.2 Operation
2.2.1 Main Screen
2.2.2 Menu
2.2.3 Startup & background
2.2.4 Daily Quality Control
2.2.5 Repeatability test
2.2.6 Calibration
37
© 2011 Mindray Confidential

38.

2.2.1 Main Screen
38
© 2011 Mindray Confidential

39.

2.2.2 Menu- QC
39
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40.

2.2.2 Menu- Setup
40
© 2011 Mindray Confidential

41.

2.2.2 Menu- Service
41
© 2011 Mindray Confidential

42.

2.2.3 Startup & Background
Before turning on the analyzer, perform the following
checks
Checking the waste container
Checking tubing and power connections
Checking the printer (optional)
42
© 2011 Mindray Confidential

43.

2.2.3 Startup & Background
After power on the analyzer
The indicator light will be on and the screen will display "Initializing…".
The analyzer will perform self-test and initialization. During the initialization
process, a progress bar will show at the bottom with message on its top
prompting "Initializing...", "Cleaning...", etc.
The whole process lasts 3 to 5 minutes. Time needed for initializing the fluidic
systems depends on how the analyzer was previously shut down.
43
After the initialization process
User name: Service
Password: s 3600!
© 2011 Mindray Confidential

44.

2.2.3 Startup & Background
After initialization, the background result will be displayed on the screen,
and they should be in following range.
44
© 2011 Mindray Confidential

45.

2.2.3 Startup & Background
Log in as a service engineer
45
© 2011 Mindray Confidential

46.

2.2.3 Startup & Background
Run background
46
© 2011 Mindray Confidential

47.

2.2.4 Daily quality control test
Before running any samples, run the controls.
47
© 2011 Mindray Confidential

48.

2.2.5 Repeatability Test
Whole blood mode:CV
Parameters
48
Prerequisite
CV% Range
WBC
7.0 ~ 15.0 109 / L
4.0 ~ 6.9 109 / L
RBC
3.50 ~ 6.50 1012 / L ≤ 2.0
HGB
100 ~ 180 g/L
≤ 1.5
MCV
80.0 ~ 110.0 fL
≤ 1.0
PLT
150 ~ 500 109 / L
100~149 109 / L
≤ 4.0
≤ 5.0
HCT
30 50%
≤ 3.0
Lymph%
20 50
≤ 1.5 SD
Mid%
2 13
≤ 1.5 SD
Gran%
30 70
≤ 3.0 SD
© 2011 Mindray Confidential
≤ 2.5
≤ 3.5

49.

2.2.5 Repeatability Test
Prediluted Mode
Parameters
49
Prerequisite
CV% Range
WBC
4.0 ~ 15.0 109 / L
≤ 4.0
RBC
3.50 ~ 6.50 1012 / L
≤ 2.0
HGB
110 ~ 180 g/L
≤ 2.0
MCV
80.0 ~ 110.0 fL
≤ 1.5
PLT
100~500 109 / L
≤ 8.0
© 2011 Mindray Confidential

50.

51.

52.

53.

2.2.6 Calibration
Before calibration, please
1) Do background test
2) Do repeatability test
3) Do carryover test
OK or not?
53
© 2011 Mindray Confidential

54.

55.

Carryover
1, Run a high-value sample 3 times continuously;
2, Run a low-value sample 3 times continuously.
3, Get the carryover% result and status: OK or failed.
55
© 2011 Mindray Confidential

56.

57.

Calibration- Transfer factor
Step1: In whole blood mode, run Calibration Calibrator, to finish the
calibration and save the factors.
57
© 2011 Mindray Confidential

58.

Calibration- Transfer factor
Step 2: Run Calibration Transfer factor, and test calibrator for 5 or more
times in whole blood mode. Make sure the CV result in following range
58
parameter
WBC
RBC
HGB
MCV
PLT
CV%
≤2.0%
≤1.5%
≤1.5%
≤0.5%
≤4.0%
© 2011 Mindray Confidential

59.

60.

Calibration- Transfer factor
Step 4:
Click the Diluent button to dispense diluent in a tube for 7 times
continuously.
Step 5:
Add 140uL calibration into the diluent, after mixing well, test the
prediluted sample for 5 or more times continuously. Make sure the
CV result in following range, and all the transfer factors in range
[0.75, 1.25].
Parameter
CV%
60
© 2011 Mindray Confidential
WBC
RBC
HGB
MCV
PLT
≤4.0%
≤2.0%
≤2.0%
≤1.5%
≤8.0%

61.

62.

2.3.1 Components
Components
Sample probe
1
Wipe block
1
pump
valve
chamber
62
Number
Waste pump
1
Gas pump
1
3-way valve
5
2-way valve
13
pressure
1
vacuum
1
10mL syringe
1
100uL syringe
1
2.5mL syringe
1
© 2011 Mindray Confidential

63.

2.3.1 Components
Components
Count
bath
63
Number
WBC
1
RBC
1
HGB assembly
1
Volumetric tube
2
Air filter
6
Waste pump filter
1
© 2011 Mindray Confidential

64.

65.

66.

2.3.1 Components
Sample Probe
For open vial mode:
Sample Probe(OV)
For closed tube:
closed sampling probe
66
© 2011 Mindray Confidential

67.

68.

69.

70.

71.

2.3.1 Components
Function of Syringes
100uL syringe (Asp-Syringe):
Aspirate and dispense the sample (dilution).
10mL syringe (Dil-Syringe):
Dispense the diluent into WBC bath, RBC bath and clean Wipe block.
2.5mL syringe (Lyse-Syringe):
Aspirate and dispense the Lyse.
71
© 2011 Mindray Confidential

72.

2.3.1 Components
Valve
When power on,
open
When power on,
switch
Three way valve
72
© 2011 Mindray Confidential
Two way valve

73.

2.3.1 Components
RBC bath & WBC bath & HGB assembly & Isolation chamber
WBC bath
RBC bath
HGB
assembly
Isolation
chamber
73
© 2011 Mindray Confidential

74.

75.

76.

77.

78.

79.

80.

81.

82.

83.

84.

85.

86.

87.

Whole blood mode in Open Vial
1, Aspirate the sample
2, Sample preparation
3, Counting
4, Clean after counting
87
© 2011 Mindray Confidential

88.

Aspirate the sample
Clean the sample probe: internal and external
Drain and prime the WBC bath
Clean the rear bath of both WBC bath and RBC bath, empty the
volumetric tube.
Aspirate 17ul sample and clean the sample probe (external).
Read the HGB blank.
88
© 2011 Mindray Confidential

89.

Aspirate
Clean
Empty
Drain the
rear
and
the
sample
volumetric
prime
bath the
WBC
tubebath
Clean
sample
probe
89
© 2011 Mindray Confidential

90.

91.

WBC Sample preparation
2, WBC sample preparation:
1) Some diluent is added into WBC bath to pre-fill it;
2) Dispense 9ul sample into WBC bath;
3) Another volume diluent is added into WBC;
4) Pressure establishing, and bubble mixing;
5) 350ul lyse added into WBC, and bubble mixing.
91
© 2011 Mindray Confidential

92.

Dispense
9ul
into
bath
Another
Pressure
350ul
lyse
volume
establishing,
added
diluent
into into
WBC,
and
is WBC
added
bubble
andbath
into
bubble
mixing
WBC
mixingit
Some
diluent
issample
added
WBC
to
pre-fill
92
© 2011 Mindray Confidential

93.

3, RBC sample preparation
1) Before Lyse injection, sample probe aspirate 34ul first dilution from
WBC bath;
2) Drain and pre-fill the RBC bath.
3) Dispense the 34ul first dilution into RBC bath and then another volume
of diluent.
4) Bubble mixing
93
© 2011 Mindray Confidential

94.

Dispense
theinjection,
34ul firstsample
dilutionprobe
into RBC
bath34ul
andfirst
then
Before Lyse
aspirate
Bubble
Drain and
mixing
pre-fill the RBC
bath
dilution from
WBC
another
volume
of bath
diluent
94
© 2011 Mindray Confidential

95.

96.

97.

98.

99.

100.

101.

102.

103.

104.

105.

106.

107.

108.

109.

110.

Data board
Functions:
(Signal board + CPU board)
1, To receive the signal from WBC, RBC/PLT channels and HGB signal;
2, To finish data processing, save and output the results;
3, To generate control signals and realize the communication.
110
© 2011 Mindray Confidential

111.

Data board
Inverter, Indicator board
drive board
Touchscreen control board
Door
USB
HGB
A±12V
Sensor
LCD
120V
USB
USB
Network
RS232
D5V,P12V
111
© 2011 Mindray Confidential
CF card
RBC
WBC

112.

113.

Drive board
Functions:
1, To control the motors, valves and pumps;
2, To monitor the pressure and vacuum;
3, To report status, such as temperature and voltage, to data board.
113
© 2011 Mindray Confidential

114.

Drive board
Volumetric board
Sensor (CT)
valves
12/24V
sensor
syringe
Motor
Sample compartment
connect board
temperature
Motor (S)
5V
Data board
114
© 2011 Mindray Confidential

115.

116.

Drive board
Adjustment:
After replacing the drive board or rinse sensor, calibrate the
photocoupler as following steps:
116
© 2011 Mindray Confidential

117.

Drive board- Adjustment
Step 1:
Log in as service engineer, run Setup Service Setup Photocoupler
Cal.
Click start.
117
© 2011 Mindray Confidential

118.

Drive board- Adjustment
Step 2:
Operate according to the message pop out .
Adjust the potentiometer VR1, until the rinse sensor calibration
indicator, D22 , light.
VR1
118
© 2011 Mindray Confidential

119.

120.

Drive board- Adjustment
Step 3:
After finishing, we will get new voltages and calibration status.
If fail, go back to Step1, if Pass, succeed.
120
© 2011 Mindray Confidential

121.

122.

123.

124.

Volumetric board
Functions:
1, To detect the pressure and
vacuum;
2, To realize the volumetric.
124
© 2011 Mindray Confidential

125.

126.

127.

128.

Troubleshooting
WBC clog
Vacuum error
No startup
Display problem
HGB blank error
Motor error
128
© 2011 Mindray Confidential

129.

WBC clog
Zap & flush for 3 times
Soak with probe cleanser
LED can not light on normally
Watch volumetric board when
counting
LED light on normally
Check the tube between rear bath
and volumetric tube, valves
Replace volumetric board
Disassembly the bath and
clean the ruby
129
© 2011 Mindray Confidential

130.

Vacuum error
Waste pump work or not
YES
Any leaking in the tube connected to pump
and vacuum chamber?
Replace the pump or drive
board
NO
Check the valves and volumetric
board
Detection error
Change volumetric board
130
© 2011 Mindray Confidential
Pump too weak, dirty or
clog

131.

Troubleshooting-No startup
Check the power
cable
OK
Disconnect volumetric
board from drive board,
and restart…
Not OK
Disconnect drive board and data
board from power supply board, and
restart …
Replace power supply
board
Not ok
OK
Ok
© 2011 Mindray Confidential
Short circuit on drive
board
OK
Only connect drive board to power
supply board, and restart…
Replace data board
131
Not
OK
Not OK
Short circuit on volumetric
board

132.

Troubleshooting- Display problem
Press reset button on data board:
S12
Software problem
Check cable between data board and LCD
& inverter
Replace the cable
Check the test points on data board
Replace the data
board
132
© 2011 Mindray Confidential
Replace LCD or inverter

133.

Troubleshooting- HGB blank error
Clean tube and bath in
software
HGB assembly light on or
not
NO
YES
Replace the HGB
assembly
Adjust the HGB gain in software until
the HGB blank voltage to be 4.45V
Blank voltage changes but can not
reach 3.2V, HGB assembly error
133
© 2011 Mindray Confidential
Voltage doesn’t change
however you adjust the
HGB gain, data board
error

134.

Troubleshooting- Motor error
Try one-button-remove error and self
test in software
YES
NO
Check the cables of motor and
sensors, check the power input
on drive board
NO
YES
Check the resistance of the
motor
YES
NO
Replace sensor, drive board, motor
134
© 2011 Mindray Confidential

135.

136.

137.

138.

139.

140.

141.

142.

Maintenance
142
Recommended maintenance content
Adjust the position of sample probe
Touchscreen calibration
Service
© 2011 Mindray Confidential

143.

144.

Maintenance
Recommended maintenance content
Maintenance Period
Every day
Content of Maintenance
If you are to use the analyzer 24 hours a day, be sure to
perform the “probe cleanser cleaning” procedure everyday.
To get reliable result, run QC program everyday before
sample test.
Every week
144
© 2011 Mindray Confidential
If you shut down your analyzer every day and follow the
specified shutdown procedure to do that, you need to perform
the “Probe cleanser cleaning” procedure every week.

145.

Maitenance
Maintenance
Period
Content of Maintenance
When you think the baths might be contaminated,
perform the “Clean the baths” procedure.
For closed tube model, the tube baffle should be
cleaned regularly to avoid possible biohazards.
As needed
When the analyzer reports bubbles in volumetric tubes
frequently, you need to check if the air filters are covered
by dust; if so, please replace the air filters.
For closed tube model, it is recommended that you
change the pierce needle whenever 30,000 samples
have been analyzed.
When this analyzer is not to be used for two weeks, be
sure to perform the “Prepare to ship” procedure to empty
and wash the fluidic lines and then wipe the analyzer dry
and wrap it up for storage.
145
© 2011 Mindray Confidential

146.

147.

148.

149.

Adjust the position of sample probe
Precondition
After replacing sample assembly.
Tools:
1, sample probe Y-position fixture
2, sample probe X-position fixture
149
Procedures:
© 2011 Mindray Confidential

150.

151.

152.

Adjust the position of wipe block
Step1: Removal the tube baffle
This step is only for closed tube model:
Tube
baffle
Screw
Tube baffle
152
© 2011 Mindray Confidential

153.

Adjust the position of wipe block
Step 2: Use the sample probe Y position fixture to take place of wipe
block
sample probe Y
position fixture
153
© 2011 Mindray Confidential

154.

Adjust the position of wipe block
Step 3: Click Move Up or Move Down to make the end of sample
probe and the bottom of sample probe Y position fixture in the same
level, then click Save.
154
© 2011 Mindray Confidential

155.

Adjust the position of wipe block
Step 4: Removal the fixture and fix the wipe block and tube baffle.
155
© 2011 Mindray Confidential

156.

Adjust the position of sample probe
2, Adjust the position of sample probe above
WBC&RBC bath
156
© 2011 Mindray Confidential

157.

Adjust the position of sample probe above WBC&RBC
bath
Step 1: Removal the shielding box of WBC/RBC bath.
Removal the bath diaphragm.
diaphragm
RBC bath
157
© 2011 Mindray Confidential
WBC bath

158.

Adjust the position of sample probe above WBC&RBC
bath
Step 2: WBC bath position adjustment:
a, Click Move right to move sample probe to right side of WBC bath.
b, Put the fixture on WBC bath and Click Move Left to move sample probe exactly
above the small hole of fixture.
Small hole
Sample probe X-position fixture
WBC bath
158
© 2011 Mindray Confidential

159.

Adjust the position of sample probe above WBC&RBC
bath
Step 3: RBC bath position adjustment
a, Click Move right to move sample probe to right side of RBC bath.
b, Put the fixture on RBC bath and Click Move Left to move sample probe exactly
above the small hole of fixture.
Small hole
Sample probe X-position
fixture
RBC bath
159
© 2011 Mindray Confidential