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Three-Channel Electrocardiograph: Shenzhen Comen Medical Instrument Co., LTD
Three-Channel Electrocardiograph: Shenzhen Comen Medical Instrument Co., LTD
Three-Channel Electrocardiograph: Shenzhen Comen Medical Instrument Co., LTD
CM100/CM300
Service Manual
Contents
Chapter 1 Safety Guidance..........................................................................................................3
1.1 Safety Information......................................................................................................3
1.1.1 Danger.................................................................................................................4
1.1.2 Warnings.............................................................................................................4
1.1.3 Cautions..............................................................................................................7
1.1.4 Notes...................................................................................................................9
1.2 Equipment Symbols....................................................................................................9
Chapter 2 Warranty and Service.......................................................................................................10
Chapter 2................................................................................................................................10
2.1 Warranty Terms.........................................................................................................10
2.2 What is excluded?.....................................................................................................11
2.3 Service Procedure.....................................................................................................11
2.4 Fill in the Service Claim Form (SCF)......................................................................12
2.5 Send COMEN the SCF and Select a Solution..........................................................12
2.6 Obtain the RMA Form..............................................................................................13
2.7 Send the Parts to COMEN........................................................................................13
2.7.1 Contact Information..........................................................................................13
Chapter 3 Principle introduction.......................................................................................................14
Chapter 3................................................................................................................................14
3.1 CM100 system principle block diagram...................................................................14
3.2 CM100 Module Introduction....................................................................................15
3.2.1 Main board (2410 core board + CM100 bottom board)...................................15
3.2.2 3.2.2CM100_300 ECG Board..........................................................................16
3.2.3 R-type transformer:...........................................................................................17
3.2.4 LCD Adapter Board..........................................................................................17
Chapter 4 Trouble Shooting..............................................................................................................18
Chapter 4................................................................................................................................18
4.1 Introduction...............................................................................................................18
4.2 Part Replacement......................................................................................................18
4.3 Checking Software Version......................................................................................18
4.4 Checking Technical Alarms......................................................................................18
4.5 Troubleshooting Guide.............................................................................................19
4.5.1 4.5.1 Failure to power on with AC supply........................................................19
4.5.2 Failure to power on with battery.......................................................................19
4.5.3 4.5.3 White or Black Screen.............................................................................19
4.5.4 Abnormal screen display..................................................................................20
4.5.5 No ECG output from certain lead.....................................................................20
4.5.6 ECG disturbance...............................................................................................20
1.1.1...................................................................................................................................21
1.1.1...................................................................................................................................21
4.5.7 Electromyograhic disturbance..........................................................................21
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1.1.1...................................................................................................................................21
1.1.1...................................................................................................................................21
4.5.8 Unstable baseline..............................................................................................21
4.5.9 Partial buttons or all buttons failure.................................................................22
4.5.10 Print problem....................................................................................................22
Chapter 5 Performance Verification..................................................................................................24
Chapter 5................................................................................................................................24
5.1 Safety Test.................................................................................................................24
5.2 5.2 Performance Tests...............................................................................................24
5.2.1 5.2.1 ECG Performance test.............................................................................24
5.2.2 5.2.2Print speed test..........................................................................................24
Chapter 6 Disassembling Procedure.................................................................................................26
Chapter 6................................................................................................................................26
6.1 Disassemble the rear panel.......................................................................................26
6.2 Separating the function board in the front panel......................................................27
6.3 Disassemble the main board.....................................................................................28
6.4 Disassemble the ECG board.....................................................................................29
6.5 Disassemble the power unit......................................................................................30
6.6 Printer disassembling................................................................................................30
Chapter 7 Software Upgrade.............................................................................................................32
Chapter 7................................................................................................................................32
7.1 Tools..........................................................................................................................32
7.2 Preparation before Upgrade System Software.........................................................32
7.3 System Software Upgrade........................................................................................32
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The design of the 3-channel electrocardiograph complies with international standard IEC 60601-1
Medical Electrical Equipment: General Requirements for Safety and IEC 60601-2-25 Particular
Requirements for the Safety of Electrocardiographs etc. The classification of this equipment is
Class І, type CF, which means a higher degree of protection against electric shock and the patient
connection is fully isolated and defibrillation protected.
This equipment is not explosion-proof. Do not use it in the presence of flammable
anesthetics.
This equipment is designed for continuous operation and is ‘ordinary’ (i.e. not drip
or splash-proof).
Classification:
Anti-electric-shock type: Class І with internal power supply
Anti-electric-shock degree: CF
Degree of safety of application in the Equipment not suitable for use in the presence
presence of flammable gas: of flammable gas
1.1.1 Danger
There are no dangers that refer to the product in general. Specific “Danger” statements may be
given in the respective sections of this manual.
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1.1.2 Warnings
In order to use the electrocardiograph safely and effectively, avoiding possible dangers caused by
improper operations, please read through the user manual and be sure to be familiar with all
functions of the equipment and proper operation procedures before use.
Please pay more attention to the following warning and caution information.
WARNING :
♦ Only qualified service engineers can install this equipment. And only
service engineers authorized by our company can open the shell.
♦ Only qualified installation or service engineers can shift the mains shift
switch (100V~115V/220V~240V) according to local mains supply.
WARNING :
♦ This equipment is not designed for internal use and direct cardiac
application.
WARNING :
♦ Only patient cable and other accessories supplied by our company can
be used. Or else, the performance and electric shock protection can not
be guaranteed.
♦ Be sure that all electrodes have been connected to the patient correctly
before operation.
♦ Do not touch the patient, bed, table and the equipment while using
defibrillator or pacemaker simultaneously.
♦ In order to avoid burning, please keep the electrode far away from the
radio knife while using electrosurgical equipment simultaneously.
WARNING :
equipment when necessary, to make sure that all these equipment are
connected with the potential equalization bus bar of the electrical
installation.
WARNING :
♦ When leakage or foul smell found, stop using the battery immediately.
If your skin or cloth comes into contact with the leakage liquid, cleanse
it with clean water at once. If the leakage liquid splashes into your eyes,
do not wipe them. Irrigate them with clean water first and go to see a
doctor immediately.
♦ When the battery’s useful life is over, contact with the manufacturer or
local distributor for disposal or dispose the battery according to local
regulations.
1.1.3 Cautions
CAUTION :
CAUTION :
♦ Before use, the equipment, patient cable and electrodes etc. should be
checked. Replacement should be taken if there is any evident
defectiveness or aging symptom which may impair the safety or
performance.
♦ Ruptured fused must only be replaced with the same type and rating as
the original.
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CAUTION :
♦ Turn off the power before cleaning and disinfection. If mains supply
used, the power cord should be drugged out of the outlet also. And
prevent the detergent from seeping into the equipment.
♦ Do not immerse the unit or patient cable into liquid under any
circumstances.
♦ Do not clean the unit and accessories with abrasive fabric and avoid
scratching the electrodes.
1.1.4 Notes
External output
Potential equalization
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Chapter 2
COMEN provides an 18 months warranty for the warranted products (main unit) and 3 months
for the accessories. The warranty period begins on the date products are shipped to customer. If
a customer promptly notifies COMEN of customer’s warranty claim hereunder, COMEN will either
repair, adjust or replace (with new or exchange replacement parts) COMEN’s products. COMEN
warrants that any service it provides to customers will be performed by trained individuals in a
workmanlike manner.
The warranty does not cover for the situations caused by the following condition:
Malfunction or damage caused by improper use or man-made failure.
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Fill in the SCF with detailed information including: Model Name, Serial Number (SN) and Problem
Phenomena. COMEN should not have any obligation to take over the case without this
information. The form can be gotten from COMEN’s Service Department.
Once the service department receives the fully filled SCF, COMEN’s engineer will offer a solution
in three working days. COMEN will follow out the case based on the two conditions below:
Within Warranty:
There are two options:
1) After receiving the Return Material Authorization (RMA) form from COMEN service
department, customer sends COMEN the defective parts and informs about the shipment
tracking number. Then we will dispatch new part(s) to your confirmed address with
confirmed shipping invoice.
2) The customer signs the Declaration Form and sends it back by email or fax. This form is
legally certificated to make sure the customer or end-user will return the defective parts to
COMEN on time. We will, at this option, dispatch the replacement one(s) with confirmed
shipping invoice.
NOTE:
Both Return Material Authorization Form and Declaration Form are offered by
COMEN service department once the SCF is confirmed by service engineer.
The customer is responsible for freight& insurance charges when the equipment is
shipped to COMEN for service, including custom charges. COMEN is responsible for
the freight, insurance & custom charges from COMEN to the customer.
Out of Warranty:
After receiving the RMA form from the service department, the customer sends defective parts
to COMEN in advance. We will analyze the problems and discuss with the customer about either
repairing or replacing the part(s). Once the maintenance fee is invoiced and paid, we will make
sure to dispatch good part(s) to the confirmed address.
NOTE:
The customer is responsible for any freight & insurance charge for the returned
product.
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Before the shipment of the materials, the customer must obtain an RMA form from our service
department, in which the RMA number, description of returning parts and shipping instructions
are included. The RMA number should be indicated on the outside of the shipping container.
NOTE:
COMEN should not have any obligation to the end-user or customer who returns the
goods without the notification by COMEN’s service department. The sender takes full
responsibility for the accounted fee.
If you have any question about maintenance, technical specifications or malfunctions of devices,
do not hesitate to contact us.
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R-Type
transformer
Battery To
Main board CM100_300
ECG board Patient
Button
board
User
Inverter
The main board is the heart of the instrument. It consists of bottom board and core board (CPU
board), it implements a series of tasks including CPU system, display processing, printing control,
keyboard signal processing. CPU system receives electrocardiogram signal that collects by ECG
board, and send to recorder after printing control system. CPU system receives also signals from
button board to finish the button board signal process, moreover, signals of lead-fall, paper
detecting, battery management are all processed by main board CPU. The main board also
process print task, CPU system receives order and data from print control system, generate
control signals for stepping motor and printer head to implements waveforms and other
information’s print. CPU system also sends order and data to display waveforms and other
information.
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ECG board process the ECG signal gets from ECG cable. It implements signal amplification
including analog circuit, A/D converter and control circuit.
Analog circuit consists of lead signal amplification, channel switch, anti-alias filter, gain control,
lead-off detection. Control circuit is Responsible for coordinating with A/D convertor, channel
switch, gain control circuit and lead-off detection circuit to implement signal acquisition and
lead-off detection, the digital lead signal will then be sent to CPU by high speed photo-coupler.
PIN ID P1
Description ECG board socket, to main board
Working voltage 5V
Module Function Measure ECG data
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PIN ID
Description
Working voltage
Module Function Voltage transformation to feed main board
PIN ID P1 P2 P4
To LCD panel To main board To Membrane
Description
button
Working voltage
Module Function LCD and button signal transmit
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4.1 Introduction
In this chapter, electrocardiograph problems are listed along with possible causes and
recommended corrective actions. Refer to the tables to check the electrocardiograph, identify
and eliminate the troubles.
The troubles we list here are frequently arisen difficulties and the actions we recommend can
correct most problems, but not all of them. For more information on troubleshooting, contact
our Customer Service Department.
Printed circuit boards (PCBs), major parts and components in the electrocardiograph are
replaceable. Once you isolate a PCB you suspect defective, follow the instructions in 7
Disassembly and repair to replace the PCB with a known good one and check that the trouble
disappears or the patient monitor passes all performance tests. Defective PCB can be sent to us
for repair. If the trouble remains, exchange the replacement PCB with the original suspicious PCB
and continue troubleshooting as directed in this chapter.
Some troubleshooting may involve software compatibility. Thus it requires you to your
electrocardiograph configuration and software version. For detailed information on version
compatibility, please contact our Customer Service Department.
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Before troubleshooting the electrocardiograph, check for technical alarm messages. If an alarm
message is presented, eliminate the technical alarm first.
For detailed information on technical alarm message, possible cause and corrective action refer
to the electrocardiograph’s Operation Manual.
AC power supply cable is not Check whether the power supply cable is
connected well. reliably connected
The two fuses defective Remove power supply cable and open the
fuse-boxes then ensure each of them is
good by multi-meter. If not, change new
The electrocardiograph fuses.
fails to start with AC
AC power supply unit defective Switch the multi-meter to AC voltage gear
power.
and test the transformer output. The
reasonable output should be 18V-20V
The electrocardiograph Battery defective. Check the battery voltage is around 14.8V
fails to start with
battery. Main board defective Change the new main board
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Keypad cable or connect cable is Check the keypad cable or connector cable
not connect well. is reliably connected
White or Black screen
System failure Change another main board
LCD adapter board or LCD cable not Check LCD adapter board or LCD cable
connect well connect well
Abnormal screen
LCD adapter board or LCD cable Change LCD adapter board or LCD cable
display
defective
Identical electrode falls off or has re-install the electrode or paste some
no reliable linked with patient body water or conductive ointment at the
contact position
Cable has been broken due to long The cable and electrode of the same model
time use or unit aging/clamp shall be used to replace the old one.
No ECG output from electrodes or chest bulbs lose
certain lead. flexibility or weak connection
ECG board and main board cable Check the internal wire between ECG
didn’t connect well. board and main board connect well.
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ECG machine, electrode, metal bed Check ECG machine, electrode, metal bed
or lead cable reliably connected with or lead cable reliably connected with
grounding grounding
Electrode and skin pasted with Switch on the ECG filtering function of the
sufficient conductive ointment. machine
The patient wearing jewelry such as Switch on the ECG filtering function of the
glasses or gems, AC disturbance can machine
not be cleared.
Communication disturbance
Switch on the shift filtering function of the
Electromyograhic The doctor talk to the patient machine to 25Hz or 35Hz, and then the
disturbance during ECG recording process recorded ECG waveforms will reduce a
little bit.
The Electrode clippers on the
arms and legs too tightened
Unstable baseline electrode installation stable, lead Switch on the shifting filtering function of
cable and electrode connected the machine to 0.1Hz, 0,2Hz or 0.5Hz, the
properly recorded ECG waveforms will reduce a
little bit.
electrode and patient skin clean
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Connector between the control open the upper cover of the machine and
panel and the line board out of re-connect the connector between control
proper connection. panel and line board
Waveforms displayed
Paper type incorrect Change the correct Paper
properly but can’t be
printed
Print head unclean Clean the print head
Print cable didn’t connect well Check the print cable is reliably connected
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Safety tests should be performed by qualified personnel every 6 to 12 months, and each time after
service use a standard safety tester to perform safety tests. The tester must comply with IEC/EN
60601-1or the local standards and statutes.
Refer to the accompanying operation instructions of the tester for test procedure details.
The performance test should be done once every 12 months or when you suspect the
measurement is incorrect.
Patient cables include two parts: main cables which are connected to the electrocardiograph and
the lead wires which are connected to the patient. Lead wires include 6 chest lead wires and
4limbs lead wires, the user can distinguish the chest leads and limb leads from the color of the
lead wires and the label on the connector.
4) Generate the heart rate 40 bpm, 80 bpm, 120 bpm, 160 bpm, 200 bpm and 240 bpm in turn.
5) Check if the HR value displayed on the screen is accurate. Error within 2 bpm is acceptable.
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c)Set the print speed as 5mm/s, and set the signal frequency as 5Hz±1%,repeated test.
d)Set the print speed as10mm/s, and set the signal frequency as 10Hz±1%,repeated test.
e) Set the print speed as 12.5mm/s, and set the signal frequency as 12.5Hz±1%,repeated test.
f) Set the print speed as 50mm/s, turn off the AC filter, and set the signal frequency as
50Hz±1%,repeated test.
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The following section describes the disassembly and reassembly procedures for the monitor and
its components
Only qualified service personnel (biomedical engineers or technicians) should open the monitor
housing, remove and replace components or make adjustments. If your medical facility does not
have qualified service personnel, contact COMEN or your local COMEN representative.
Caution High-Voltage – Voltages dangerous to life are present in the instrument when it is
connected to the mains power supply. Do not perform any disassembly procedures (other than
server removal) with power applied to the instrument. Failure to adhere to this warning could
cause serious injury death.
Tools required
Small flat head screwdriver
Needle Nose Pliers
ESD mat and wrist strap
Cleaning Agent
Chapter 6
1. First unscrew all screws in the back panel of the monitor below
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Battery
compartmen
t
SCREWS
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2. After separating the front panel from the back panel. You will see some cable connecting with
both. Unplugging those cable
3. Then unplug indicate cable, LCD transmit board LCD FFC ribbon cable and next you should
unscrew all screws then remove these board.
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1.After separating the front and back panel ,finding the back panel including four parts (printer
,power unit ,ECG board ,main board )
Power unit
ARM board
Bottom board
ECG board
Printer head
2.Unplug the monitoring board (unplug the printer ribbon cable remove monitoring board) first
then unplug the cable between main board and ECG board, unscrew four PA3x8 screws and then
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unplug the printer ribbon cable carefully. Last do not forgot to unplug the power cable and
monitoring cable)
1. Separating ECG board (unplug the four PA3x8 screws and then remove the fan (unscrew two
screws and unplug fan cable connecting power board)
Unscrew
four PA3X8
screws
1. Separate the power main board (unplug the grounding cable and AC power cable .Then
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1. Unscrew all screws in the printer support below. Then remove the printer support from the
main board.
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The system software is able to be upgraded with the USB disk through USB interface on monitor.
7.1 Tools
1. Before software upgrade, please check software version and take it down to make sure you
are able to revert back in case the failure of software upgrade.
2. Take a USB disk, the size of the USB disk should be 2GB or less, format it to “FAT” format
before software upgrade;
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4. Unzip the package file that got from COMEN and copy the folder * to the root path on USB
disk, do not change the folder name or the file name(s) in the folder unless you are informed by
COMEN to have the necessary change.
* Generally the folder name should be “COMENSOFT”, “CMC90_BigHost” (for C90 only)
or “CMC70_BigHost” (for C70 only);
4. Turn off the monitor before software upgrade.
After the preparation work’s done, please plug USB disk on the USB interface of the monitor, and
then turn on the monitor, the monitor will then detect the upgrade package, software upgrade will
be automatically done, the display will then show “System is updating” and “System update
success!” to indicate the status during software upgrade process.
After the display shows “System update success!”, please unplug the USB disk and restart monitor
to check the new software.
NOTE
Make sure you have confirmed with COMEN Customer Service Department the
software package is fit for the software upgrade for the monitor you are currently
operating on.
Disconnect the patient monitor from patient before software upgrade;
Make sure the battery capacity is enough or plug on AC power while doing the software
upgrade process, it takes around 2-10 minutes during the whole upgrade;
Program upgrade should be performed by qualified service personnel only.
Do not unplug the USB disk during the software upgrade process.
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