C2000-2&4 Service Manual V3.0
C2000-2&4 Service Manual V3.0
C2000-2,C2000-4
Semi-Auto Coagulation Analyzer
Service Manual
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H-046-013294-00(3.0) C2000 Series Service Manual
Preface
Intellectual Property
Beijing Precil Instrument Co., Ltd. owns the copyright of this non-public manual
and has the rights to keep this manual confidential. This manual provides
reference only for maintaining products.
The manufacturer owns all intellectual property rights (including the copyright) of
this manual. It is prohibited to use, disclose, or spread the information in this
manual in any manner without the prior written approval of manufacturer. It is
prohibited to photograph, copy, print, or translate (or conduct any other similar
activities) the information in this manual in any manner without the prior written
approval of manufacturer.
Disclaimer
Manufacturer is not liable for this manual in any manner, including (but not limited
to) the warranty of merchantability or fitness implied in this manual for any
particular purpose.
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H-046-013294-00(3.0) C2000 Series Service Manual
● Application Scope
This manual applies to the product maintenance conducted by customer service
engineers or manufacturer authorized personnel.
Warnings
Warning 1
Before maintenance, carefully read the operation and safety instructions in this
manual to ensure proper operations.
Warning 2
When the operating environment of the instrument does not comply with the
Operation Manual for C2000 Series Semi-Auto Coagulation Analyzers, the
instrument may not operate properly or even become faulty.
Warning 3
Sudden power failure:
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H-046-013294-00(3.0) C2000 Series Service Manual
When a transient voltage drop occurs due to power failures or lightning strikes,
the instrument may become faulty. In addition, the basic software, application
software, data, as well as memory data and software may be damaged.
Commitment
Warranty Period:
Manufacturer provides a one-year warranty and lifelong maintenance for the
product. Maintenance services and accessories are free of charge during the
warranty period. After the warranty period expires, customers are charged for
replaced accessories and maintenance services.
Warranty Particulars:
During the warranty period, manufacturer provides free-of-charge maintenance
against faults relevant to the product design and manufacturing. Maintenance
methods are determined by the manufacturer based on the faults.
Exemptions:
(1) The operating environment does not meet the requirements of this
manual.
(2) The customer misuses, misoperates, or operates the product in a rough
manner.
(3) The product is not moved, transported, or installed in accordance with
the procedures and methods recognized by the manufacturer.
(4) The product is disassembled without permission.
(5) The product is damaged in natural disasters (including fire accidents,
earthquakes, floods, wind disasters, and thunderstorms), terrorist
activities, wars, or other acts of God.
(6) The customer uses parts that are not provided by the manufacturer.
(7) Consumable parts become faulty, or the service life of the components
expires.
(8) The customer does not maintain the product in accordance with the
manufacturer's requirements.
(9) The customer buys a second-hand product without contacting the
manufacturer.
(10) The system crashes or the hardware is damaged due to computer
viruses.
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H-046-013294-00(3.0) C2000 Series Service Manual
After-Sales Service
Service Particulars:
Installation and commissioning: customer service department and local
distributors
Application training: customer service department and local distributors,
providing free-of-charge training on installation and on-site applications
Maintenance: customer service department and local distributors
Supply of accessories:Beijing precil instrument co., Ltd and local distributors
Direct service
The customer service engineers provide direct services for customers.
Contact Information
Address: Room 203,204&401, Building 2,No.2 Tongji Middle Road,Beijing
Economic & Technological Development Area,Beijing,100176,China
Telephone: +86-10-62987758
Postcode: 100176
Fax: +86-10-62987761
Customer Service Department: 400 700 5652
Version V3.0
Publish date 2018.09.28
Modified date 2019.12.25
File No. H-046-013294-00
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.
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H-046-013294-00(3.0) C2000 Series Service Manual
Symbols
Warning Symbols
The following symbols are used to indicate danger and alert information on the
instrument.
Symbols Meaning
Inside of Please notice the PCB, do not touch and measure it when
instrument electrified.
There is blood in the semi cuvette, please wear medical
gloves. Used cuvette should be disposed as medical waste
appropriately for the sake of avoiding potentially
External of bio-hazardous condition.
instrument
Caution, the running instrument has hot surface!
Do not put steel ball in the stir hole!
Symbols
During the daily use of the analyzer, especially the cleaning process, the operator shall
ensure the intactness of the labels.
Symbols Meaning
Caution, consult accompanying documents. Note: suggesting the
users consult to accompanying to get important safety information.
Biological risk
The device is fully conformance with the council directive concerning
in vitro diagnostic medical devices 98/79/EC
Serial number
Date of manufacture
Manufacture
The following definition of the WEEE label applies to EU member
states only: the use of this symbol indicates that this product should
not be treated as household waste. By ensuring that this product is
disposed of correctly, you will help prevent bringing potential
negative consequences to the environment and human health. For
more detailed information with regard to returning and recycling this
product, please consult the distributor from whom you purchased the
product.
Authorized representative in the European community.
Safe Symbols
The following symbols are sticked in or on the instrument; user should comprehend the
meaning.
Symbols Meaning
Caution, consult accompanying documents. Note: suggesting
the users consult to accompanying documents to get important
safety information.
On (power: connection to the mains)
Please use the analyzer strictly as instructed by this manual, the wrong operation will
destroy your analyzer and hurt the operator.
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H-046-013294-00(3.0) C2000 Series Service Manual
Content
Preface ................................................................................................................... - 1 -
Intellectual Property ................................................................................................. - 1 -
Disclaimer .................................................................................................................. - 1 -
Warnings .................................................................................................................... - 2 -
Commitment .............................................................................................................. - 3 -
After-Sales Service .................................................................................................. - 4 -
Symbols ..................................................................................................................... - 5 -
Chapter 1 Structure and Function.........................................................................3
1.1 Structure ..............................................................................................................3
1.1.1 Structural Diagram of C2000-2 ......................................................................3
1.1.2 Structural Diagram of C2000-4 ......................................................................6
1.2 Parts and Functions .......................................................................................11
1.2.1 Power Switch Board......................................................................................11
1.2.2 Heating Board ................................................................................................12
1.2.3 LCD..................................................................................................................14
1.2.4 Main Board .....................................................................................................15
1.2.5 Network Access Board .................................................................................16
1.2.6 Test Strip ........................................................................................................16
1.2.7 Mixer Motor ....................................................................................................16
1.2.8 Fuse ................................................................................................................17
1.3 Technical Parameters ....................................................................................17
1.3.1 Normal Working Condition ..........................................................................17
1.3.2 Temperature ..................................................................................................18
1.3.3 Specification ..................................................................................................18
1.3.4 Contraindications ..........................................................................................18
Chapter 2 Troubleshooting .....................................................................................19
Chapter 3 Debugging ..............................................................................................22
3.1 Checks to Be Performed Before Debugging and Maintenance ................22
3.1.1 Check whether all parts are installed properly and whether lines are
intact with good connectivity. ......................................................................22
3.1.2 Check whether the pre-heating hole and test hole are blocked or
damaged.........................................................................................................22
3.1.3 Check whether the power voltage output is normal. ...............................22
3.2 Circuit Board Installation .................................................................................22
3.2.1 Add loads on the power supply to enable discharge before the
installation. .....................................................................................................22
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H-046-013294-00(3.0) C2000 Series Service Manual
3.2.2 Install circuit boards in the specified positions and connect the
corresponding signal cables. .......................................................................22
3.3 Self-Check and Version Check ......................................................................22
3.4 Temperature Calibration .................................................................................23
3.5 Channel Calibration ..............................................................................................24
Chapter 4 Maintenance and Cautions ..................................................................25
4.1 System Principle Diagram...............................................................................25
4.2 Cable Layout Diagrams ...................................................................................26
4.2.1 Cable Layout Diagram of C2000-2 .............................................................26
4.2.2 Cable Layout Diagram of C2000-4 .............................................................27
4.3 Safety Category ................................................................................................28
4.3.1 Electrical Safety .............................................................................................28
4.3.2 Electromagnetic Compatibility .....................................................................28
4.4 Cautions .............................................................................................................28
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H-046-013294-00(3.0) C2000 Series Service Manual
Ball supplying
device hole
Built-in micro
printer
Reagent
preheating
area
Sample Test
preheating area area
LCD
Membran
e keypad
Top case
Bottom
case
Figure 1.1 Front view of C2000-2
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H-046-013294-00(3.0) C2000 Series Service Manual
Pipettor
connector
Printer
Heating board drive board
Mixer motor
drive board
Main board
LC
D
Top
case
Network
access
board
Power switch
board
Bottom case
Bottom case
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H-046-013294-00(3.0) C2000 Series Service Manual
Ball supplying
device hole
Built-in micro
printer
Top case
Reagent pre-heating
position
LCD
Position of
the pipettor
Membrane
keypad
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H-046-013294-00(3.0) C2000 Series Service Manual
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H-046-013294-00(3.0) C2000 Series Service Manual
Mixer motor
drive board
Heating board
(small) Printer drive
board
LCD
Test strip
Main board
Top case
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H-046-013294-00(3.0) C2000 Series Service Manual
Power switch
board
Power supply
board
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H-046-013294-00(3.0) C2000 Series Service Manual
▪ Do not use any decontamination or cleaning agents which could cause a HAZARD as a
result of a reaction with parts of the equipment or with material contained in it. If there is
any doubt about the compatibility of the decontamination or cleaning agents with parts
of the equipment or with material contained in it, please contact our customer service
department or the local distributor.
• If you accidentally spill hazardous material (for example, reagents) on the instrument,
clean and sterilize the instrument with specified disinfectant. 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.
▪ The user shall perform daily cleaning and sterilization to the cover of the analyzer. Use
the specified materials to sterilize the equipment only. For any damage to the instrument or
other accidents caused by using materials other than specified, Manufacturer will not provide
any warranty.
▪ The cleaning may damage the system to some extent. It is recommended to perform the
cleaning only when necessary according to your laboratory protocol.
▪ During equipment repair, transportation and treatment, wash and disinfect the device
surface, the components having biological risk, and remind the personnel concerned about
the device risk, so as to avoid biohazards and other hazards during handling or repair.
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H-046-013294-00(3.0) C2000 Series Service Manual
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H-046-013294-00(3.0) C2000 Series Service Manual
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H-046-013294-00(3.0) C2000 Series Service Manual
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H-046-013294-00(3.0) C2000 Series Service Manual
1.2.3 LCD
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H-046-013294-00(3.0) C2000 Series Service Manual
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H-046-013294-00(3.0) C2000 Series Service Manual
1.2.8 Fuse
Inlay-fuse is located inside power module, and outlay-fuse is located above sock. When
users want to replace fuse, please shut-down analyzer firstly, take out power line, replace
the new fuse according to the specification(Fuse specification: 2A/250V/20mm,identification:
F2AL250V ). If there is any query, please contact with customer service department or local
distributor.
The user can only change fuse (Be sure the power is turned off), in order to ensure the
security of user, other problems about your analyzer please call customer service.
1.3.2 Temperature
The test can be carried out only after the coagulation analyzer is switched on for
preheating until the experimental temperature reaches 37℃ and is preserved in 37℃±
1℃, with the preheating time lasting not more than 30 minutes.
1.3.3 Specification
1.3.4 Contraindications
None.
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H-046-013294-00(3.0) C2000 Series Service Manual
Chapter 2 Troubleshooting
No Corrective
Fault Possible Cause Check
. Action
Check the operation Standardiz
Some of the
a. Operation problem procedure according to the e
four
instructions. operations.
1 coagulation
Replace
parameters
b. Reagent problem Check the reagent quality. the
are abnormal.
reagent.
The test
results are Improve
inconsistent, Improve the precision of the
2 Sample loading problem
and precision sample loading. operation
does not meet proficiency.
requirements.
The R value a. Inaccurate dilution of
of FIB curve calibration plasma Create a
does not Check whether the R value new
3 b. Improper operations
meet is less than 0.98. standard
and inaccurate sample
requirements curve.
loading
.
a. The room
temperature is
displayed on the
The
instrument, indicating Replace
temperature Check the power
4 no heating. the faulty
display is supply or triode (540).
b. The temperature part.
abnormal.
displayed on the
instrument is higher
than 40°C.
The
temperature
display is Adjust the
The temperature Check the temperature
normal, but the temperatur
5 coefficient is not set according to the
actual e
properly. temperature indicator.
temperature is coefficient.
higher than
37°C.
The membrane keypad Replace
The keys do
6 connection is poor or the
not respond.
the keys are faulty. membrane.
Check whether the
The pipette
connection of the Rectify the
does not
7 pipette is normal and open
respond when
whether open circuits circuits.
you press it.
occur.
The mixer motor makes
There is a loud Adjust the
a loud noise. The
noise during position of
8 position of the mixer
reagent the mixing
motor magnet support is
mixing. rod.
incorrect.
The system The power cable is not Replace
Check whether the voltage
9 does not connected properly, or the faulty
at the GP point is 5 V.
respond after the fuse or rectifier part.
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H-046-013294-00(3.0) C2000 Series Service Manual
No Corrective
Fault Possible Cause Check
. Action
power-on. bridge is burned out.
The power chip (2596)
is burned out.
The measured Create a
FIB values are The standard curve is new
10
too high or too abnormal. standard
low. curve.
Use the
a. The cup and steel ball
Check whether the "NO original
are not produced by
BALL" prompt is displayed. steel ball
Manufacturer.
and cup.
Check whether the
amplitude becomes
b. The amplitude of the
smaller as the R15 (10 Ω) Replace
steel ball is too small or
increases and becomes the resistor.
too large.
larger as the R15 (10 Ω)
decreases.
The null value does not
meet requirements: 1.
short circuit of the test strip
(the null value is about 400 Replace
or 500); 2. open circuit of the test
the test strip (the null value strip or
is 0); capacitor.
3. breakdown or capacity
No steel ball decrease of the 12 V filter
11 is detected. capacitor (C5).
(NO BALL) The plasma calibration is
unqualified. The calibration
value is more than or less
Test the
than 20 times of the null
capacitanc
c. Calibration problem value. Check the capacitors
e of the
corresponding to channels
channels
1, 2, 3, and 4. Channels 1,
by using a
2, 3, and 4 correspond to
capacitanc
capacitors C52/C53,
e meter
C54/C55, C56/C57, and
and replace
C58/C59 respectively. If the
the
calibration value is more
capacitors
than 20 times of the null
based on
value, use capacitors with a
the plasma
smaller capacity. If the
calibration
calibration value is less
value.
than 20 times of the null
value, use capacitors with a
larger capacity.
Check the resistance of the
The plasma test strip (50 Ω for two Replace
solidifies, and a. The test strip is faulty. groups of coils, and 180 Ω the faulty
the ball stops for another two groups of part.
12
moving, but coils).
the counting Replace
b. No –5 V voltage is Check the 8th pin of U10
continues. the faulty
available. (7660 chip).
part.
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H-046-013294-00(3.0) C2000 Series Service Manual
Please perform system maintenance as per this Service Manual. Improper maintenance
measures may lead to incorrect analysis results and even system damage or personal
injury.
Dust may accumulate on the surface after long-term storage of the system. Wipe the
surface gently by a piece of clean soft cloth soaked with water and then wrung out, and
a little soap solution can be used if necessary. Do not use organic solvents like alcohol.
Dry the surface by a piece of dry cloth after cleaning.
Turn off all power supplies of the system and pull out the power plug before cleaning.
Necessary measures shall be taken to prevent water drop from entering the system
during cleaning, or system damage or personal injury may happen.
In the case that the device requires service due to any fault, please contact the
Customer Service Department. During repair, the device may be shut down or
transported, please operate carefully to avoid any biohazard, electric shock hazard
caused by repair.
Check the equipment state after repair. Make sure the equipment is safe before offering
it to users.
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H-046-013294-00(3.0) C2000 Series Service Manual
Chapter 3 Debugging
This chapter describes the methods for debugging the instrument, including the pre-
debugging checks, circuit board installation,start up self-checking,temperature calibration
and channel calibration.
Maintenance engineers must learn the following precautions before debugging:
(1) Disconnect the power supply before replacing a component or
inserting/removing a conductor.
(2) Do not pull or twist the cable when removing a plug.
(3) Prepare a multimeter and other common tools.
3.1.2 Check whether the pre-heating hole and test hole are blocked or damaged.
3.2.2 Install circuit boards in the specified positions and connect the
corresponding signal cables.
Menu Description:
TEL: after-sales service telephone of the manufacturer
V x.x: version of the instrument
Main menu: After the start menu is displayed, the instrument automatically enters the main
menu, as shown in Figure 3.2.
- C2000 - T=x.xx
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H-046-013294-00(3.0) C2000 Series Service Manual
3.4Temperature Calibration
The instrument temperature is detected and controlled by the built-in temperature sensor
and may be inaccurate. Therefore, it must be calibrated by using a standard thermometer
certified by the national metrology department.
(1) After the instrument starts, wait until the temperature displayed on the instrument
reaches 37°C. Add 150 µl distilled water to a test cup, place the test cup into any
pre-heating hole, insert a standard thermometer certified by the national metrology
department into the test cup, wait 3 to 5 minutes, and read the temperature on the
standard thermometer.
(2) Temperature Calibration Setup
On the main menu, move the cursor by using the left and right arrow keys. Select
System and press OK. The system menu is displayed, as shown in Figure 3.3.
Menu Description:
Printer=xxx: Four options are available for this parameter.
=On1: instant print; =Ons: batch print; =Prt: to start Ons; =Off: to stop print.
Beep=xxx: Three options are available for this parameter.
=All: to enable the Beep during sample loading and pre-heating; =Tst: to
enable the Beep only during sample loading; =Off: to disable the Beep.
stir=xxx: Two options are available for this parameter.
=On: to enable the stir switch; =Off: to disable the stir switch.
Temperature Coefficient 1 and Temperature Coefficient 2: Temperature
coefficients of the test area and the reagent pre-heating area.
Temperature Coefficient 1: Temperature coefficient of the test area; Temperature
Coefficient 2: temperature coefficient of the reagent pre-heating area.
xxxx xx-xx xx:xx:xx: Current time in the format yyyy mm-dd hh:mm:ss. You
can set the time as required.
T=xx.x: Current temperature displayed on the instrument.
① You can set the printer, buzzer, and time as required.
② Temperature coefficient: The instrument displays the temperature of the test
area. The temperature is commissioned at room temperature before delivery.
However, the temperature sensor is highly sensitive to the ambient
temperature. If the deviation of the instrument temperature exceeds ±0.5°C
during installation, you can adjust the temperature coefficient. Adjustment
method: Move the cursor to Temperature Coefficient and press OK. Adjust the
temperature coefficient by using the left and right arrow keys, press OK, and
exit the menu. The setting is saved. Adjustment rule: The temperature
displayed on the instrument changes by 0.4°C when the temperature
coefficient changes by 0.01. Example: The temperature coefficient is 1.000,
the actual temperature is 36.4°C, and the temperature displayed on the
instrument is 37.0°C. In this case, you can adjust the temperature coefficient to
0.990. The temperature coefficient of the test head is set by the manufacturer
before delivery. If the temperature accuracy meets the requirement, do not
modify the temperature coefficient.
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H-046-013294-00(3.0) C2000 Series Service Manual
(2) Media test: Add 150 µl PVP (or plasma in a hospital) to a test cup with a steel ball,
pre-warm it for 3 minutes, place it in a test channel, observe the movement of the steel
ball, and enable tests for all test channels. The instrument counts and obtains the
calibration data, which ranges from 100 to 1023 and is equal to or greater than 10
times the corresponding null data.
When the values in the null test and media test meet requirements, enter the
system menu and set the system time to the current time. The calibration is
completed.
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H-046-013294-00(3.0) C2000 Series Service Manual
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H-046-013294-00(3.0) C2000 Series Service Manual
打印头
C11
液晶屏 C9
J4 打印
051-002432-00液晶屏转接板 小板
J2 J1 J3 1210304
打印主板
J1 J2 C12
触摸屏
C10
1210506 RS232
入网板
C8
RS232 KEY C14
M1
1210301 051-001911-00 搅拌
LCD PRT C13 搅拌电机板
加样枪座 U18 主板 电机
C6 J2 J1
CTRL1 PWR CTL
C5
1210302
加热板
CTRL VM
C7
022-000320-00
051-002075-00 CN1
J3 24V/120W 开关电源
电源转接板
RPS-120-24
J1 CN2
C4
C3
C2 C1
·
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H-046-013294-00(3.0) C2000 Series Service Manual
打印头
C11
J4 打印
小板
液晶屏 J3 1210304
打印主板
C9
触摸屏
J1 J2 C12
C10
KEY PRT M1
1210401 051-001911-00 搅拌
加样枪座 GUN 主板 C13 搅拌电机板 电机
TMP
C6 J2 J1
C5 1210402
1210403
加热板1
加热板2
CTRL VM CTRL VM
C7
C7
022-000320-00
051-002075-00 CN1
J3 24V/120W 开关电源
电源转接板
RPS-120-24
J1 CN2
C4
C3
C2 C1
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H-046-013294-00(3.0) C2000 Series Service Manual
a) This IVD medical equipment complies with the emission and immunity requirements
described in IEC 61326-1:2012 / EN 61326-1:2013 and IEC 61326-2-6:2012 / EN
61326-2-6:2013.
b) The intended use environments of this IVD medical equipment includes typical
healthcare environments (hospitals, clinics, doctor’s offices), this equipment has been
designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio
interference, in which case, you may need to take measures to mitigate the interference.
c) Advise that the electromagnetic environment should be evaluated prior to operation of
the device.
d) Do not use this device in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these can interfere with the proper operation.
4.4 Cautions
1. Keep clean, keep the test hole cleaning is especially important, anything else is not
permitted to enter the hole.
2. Do not expose the instrument to sunlight and keep the instrument away from the
high temperature.
3. Make sure to let the instrument on a stable operation table, no vibration and shaky
is permitted.
4. Prevent the instrument from moisture and etching; keep both the instrument and
steel ball loader far from the interference source of strong electro-magnetic field.
5. Power supply is AC100-240V. Be sure to use the stabilizer when the local power
source is not stabilized.
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H-046-013294-00(3.0) C2000 Series Service Manual
6. To change fuse: the power supply must be cut off during the time of changing fuse,
load the new fuse strictly according to the specification shown on the side of fuse
box (the specification of fuse is 2A/250V/20mm).
29