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C50 Service Manual

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Patient Monitor

C50

Service Manual
Intellectual Property Statement
Factory owns the intellectual property rights to this product and this manual. This manual may refer to
information protected by copyrights or patents and does not convey any license under the patent rights of
factory. Nor the rights of others. Factory does not assume any liability arising out of any infringements of
patents or other rights of third parties.
Factory intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the written permission of
factory in strictly forbidden.
Contents of this manual are subject to changes without prior notice.

Revision History
This manual has a revision number. This revision number changes whenever the manual is updated due to
software or technical specification change. Contents of this manual are subject to change without prior
notice.
Version number: A
Release time: Jun. 2016
@ 2012 Factory. All rights reserved.

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Preface
Manual Purpose
This manual provides detailed information about the assembling, disassembling, testing and troubleshooting
of the equipment to support effective troubleshooting and repair. It is not intended to be a comprehensive,
in-depth explanation of the product architecture or technical implementation. Observance of the manual is a
prerequisite for proper equipment maintenance and prevents equipment damage and personnel injury.

This manual is based on the maximum configuration. Therefore, some contents may not apply to your
monitor. If you have any question, please contact our Customer Service Department.

Intended Audience
This manual is for biomedical engineers, authorized technicians or service representatives responsible for
troubleshooting, repairing and maintaining the patient monitors

Passwords
A password may be required to access different modes within the monitor. The passwords are listed below:
Demo mode: 5188
User maintenance: 5188
Factory maintenance: 2016

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Content{TOC \o "1-3" \h \u }

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Chapter 1 Safety

1.1 Safety Information

1.1.1 Danger

There are no dangers that refer to the product in general. Specific “Danger” statements maybe given in the
respective sections of this manual.

1.1.2 Warning

Warning

 This monitor is used for monitoring the clinical patients, so only the doctors and nurses who are
qualified through training can use this monitor.
 Before use, the user shall check whether this instrument and its accessories can work normally
and safely.
 The alarm volume and upper and lower limits for alarm shall be set for different patients.
When a patient is monitored, the audible alarm system cannot be merely depended on. Alarm
volume too low or totally off will result in invalid alarm and endanger patient safety. The most
reliable patient monitoring method shall be to closely monitor the actual clinical situation of the
patient.
 This instrument can only be connected to a power socket with protective grounding. If the
power socket is not connected to grounding conductor, do not use it, but use the rechargeable
batteries for power supply.
 Do not open the enclosure of this instrument to avoid the possible electric shock hazard. The
maintenance and upgrading of this monitor must be conducted by the service personnel trained
and authorized by COMEN
 The disposal of packaging materials shall comply with the local laws and regulations or the
waste disposal rules and regulations of the hospital. The packaging materials must be placed
away from the children.
 Do not use this instrument at the place where there are flammable articles such as anesthetic to
prevent explosion or fire from happening.
 Please carefully install the power lines and the cables for various accessories to avoid the
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patient from being constricted or suffocated or the cables from getting entangled and keep the
patient free from electrical interference.
 Do not use mobile phone near the monitor, because the mobile phone will generate a very strong
radiation field and disturb the functions of the monitor.
 For the patient with pacemaker, cardio tachometer might measure the heart rate by the pulse of
pacemaker when cardiac arrest or arrhythmia. Do not completely rely on the alarm of cardio
tachometer. The patient with pacemaker shall be closely monitored. For the inhibiting capacity
of relevant equipment on the pacemaker, refer to the Instruction Manual.
 The operators shall not touch the patients, tables and instruments during the defibrillation
period.
 Before reusing these cables, check whether the function is normal.
 The equipment connected with the monitor shall form an equipotential body (the protective
grounding wire is effectively connected).
 When the monitor is used in conjunction with the electrosurgical unit, the user (doctor or
nurse) shall ensure the patients safety.
 The physiological waveforms, physiological parameters and alarm information, etc. displayed
by this monitor shall be for the doctors’ reference only and cannot be directly used as the
clinical treatment basis.
 The electromagnetic field will affect the performance of this instrument, so the use of the other
equipment near this instrument must meet corresponding EMC requirements. For example:
Mobile phone and X-ray equipment may be an interference source, because they will transmit
high-strength electromagnetic radiation.
 This monitor cannot be used in MRI room.
 This is not a treatment device.

1.1.3 Cautions

Caution

 To avoid damage to this instrument and guarantee patient safety, please use the accessories
designated in this instruction manual.
 Please properly install or move this instrument and prevent the instrument from being
damaged due to fall, collision, strong vibration or other external mechanical forces.
 Before the instrument is switched on, please confirm whether the power supply used meets the
requirements for power supply voltage and frequency specified on the nameplate label or in the
instruction manual of this instrument.

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 When this instrument and its accessories are about to exceed the service life, they must be
disposed of according to local relevant laws and regulations or the rules and regulations of the
hospital.

1.1.4 Notes

Notes

 Please install the equipment in a place that is convenient for observation, operation and
maintenance.
 This instruction manual introduces the product according to the most complete configurations.
The product you have purchased may not possess some configurations or functions.
 Please place this instruction manual near the instrument for easy and timely reference.
 This instrument cannot be used at home.
 This instrument can be used for one patient only at the same time.

1.2 Equipment Symbols

1. Instrument Symbols

Attention! please see the


AC indicator lamp
accompanying documents

BF applied part with


Production Date Mark
defibrillator-proof protection

The application part of Type


Serial number mark
CF

The application part of Type


Equipotential symbol
BF

Start/Stop Key Network connection symbol

Battery working state indicator


SD card interface
lamp

Battery charging indicator


Nurse calling socket
lamp

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VGA VGA interface USB interface

2. Packaging Symbols

Up Limit of stacking layers

Fragile Rainproof

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Chapter 2 Warranty and Service

2.1 Warranty Terms

COMEN provides 24 months warranty for the device (main unit) and 6 months for the accessories. The
warranty period begins on the date products are shipped to customer. If a customer promptly notifies us of
customer’s warranty claim hereunder, we will either repair, adjust or replace (with new or exchange
replacement parts) our products. COMEN warrants that any service it provides to customers will be
performed by trained individuals in a workmanlike manner.

2.2 What is excluded

The warranty does not cover for the situations caused by the following condition:
♦ Malfunction or damage caused by improper use or man-made failure.
♦ Malfunction or damage caused by unstable or out-of-range power input.
♦ Malfunction or damage caused by force majeure such as fire and earthquake.
♦ Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service
people.
♦ Malfunction or damage caused by use of parts or accessories not approved by COMEN
♦ Malfunction of the instrument or part whose serial number is not legible enough.
♦ Others not caused by instrument or part itself.

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2.3 Service Procedure

2.3.1 Fill in the Service Claim Form (SCF)

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 our company’s Service Department.

2.3.2 Send COMEN the SCF and Select a Solution

Once the service department receives the fully filled SCF, our engineer will offer a solution in three working
days. We will follow the case based on the two conditions below:
 Within Warranty
There are two options:
1. After receiving the Return Material Authorization (RMA) form from our service department, customer
sends us 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 us on time. We will,
at this option, dispatch the replacement(s)with confirmed shipping invoice.

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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. We are 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.

2.3.3 Obtain the RMA Form

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 packaging box.

NOTE
 COMEN should not have any obligation to the end-user or customer who returns the goods without
the notification by our service department. The sender takes full responsibility for the accounted fee.

2.3.4 Send the Parts to COMEN

Follow these suggested instructions:


 Please disassemble the parts with anti-static facility.
 Please pack the parts safely before return.
 Please put the RMA number on the parcel.
 Please describe the returned parts as‘sample of *****’and put the total value on the invoice, and note

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on the invoice as‘sample, no commercial value’.
 Please confirm the information (such as price in invoice, address and other necessary issues) with us
before shipment.
 Please send back the parts after our company’s confirmation.

2.3.5 Contact Information

If you have any question about maintenance, technical specifications or malfunctions of devices,
do not hesitate to contact us.
 COMEN International After-Sale Dept.
 Monday to Friday 09:00-18:00 (UTC +08:00)
 Tel: +86-755-26431236(ext. 333)
 Add: Floor8, Block3, 4th Industrial Park of Nanyou Nanshan District, Shenzhen 518052, P.R.
China

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Chapter 3 Principle Introduction

3.1 C50 System Principle Block Diagram

3.2 Module Introduction

3.2.1 Main board (9G45)

The main board is the heart of the patient monitor. It implements a series of tasks including input& output
control, data storage and processing, display processing, system control, communication management,
printing management and alarming, etc.

The main board comprises the core board and bottom board. The core board is an essential CPU system
containing the CPU, FLASH, memory, realtime clock, EEPROM, etc. It interfaces to the bottom board only.

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The bottom board is in charge of connections and communications with other internal modules.

PIN ID Description Working Voltage


P1 LCD signal socket(LVDS) 12V,5V
J29 LCD signal socket(TTL) 12V,5V,3.3V
J33 FPC socket(to DC board) 19V,18V,12V,5V,1.8V
J1 Key1 socket 19V,12V,5V
J4 Key2 socket 19V,12V,5V
J32 Printer socket 18V,5V
P7 WIFI socket 3.3V
J7 Alarm socket 5V
J6 Touch screen socket /

3.2.2 7-parameterBoard

The parameter board is a parameter measurement components, the 7-parameter board provides the following
functions:

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1. NIBP measurement;
2. 2-channel TEMP measurement;
3. IBP socket available for adapting IBP module;
4. SPO2 socket available for adapting Digital/Nellcor/Masimo SPO2 module;
5. ECG socket available for adapting 12-Lead ECG module;
3. Data exchange with the main board through the serial ports.

PIN ID J6/J7 J3/J4 J8/J9 J11 J1 J2 J5/J10 J12


Digital/ Masimo IBP To To To To side ECG
Nellcor SPO2 socket Power NIBP NIBP panel socke
Description
SPO2 socket board Pump Valves J6/J11 t
socket J12
Working 3.3V, 3.3V 5V 5V, 12V 5V,12 3.3V, 5V,±
voltage 5V 12V V 5V 8V

3.2.3 DC Power Supply Board

The power module is located at the back of the patient monitor. The main part of the power module is the
power board, which contains charging & power management , distributed different DC power to main
board ,7-parameter board, USB port, speaker and battery charging.

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CN1(A CN2(A J1 J4 J5 J7 J10 J25
PIN ID
C) C
AC To DC To AC To Loud Co2 To Battery
input board board main speaker socket USB/NET socket
Description
socket socket socket board socket board
socket socket
100-250 15V 15V 15V,12 / 5V 5V,1.8v 16.8V
Working
V(AC) V,5V,1.
voltage
8V
Function Provide power to main board

3.2.4 AC Power Supply Board

The power module transforms the input power into DC and then forwards them to each component of the
patient monitor. The input power comes from AC source. The patient monitor will run power from the AC
source whenever an AC source is available. If the AC source becomes unavailable, the patient monitor will
automatically switch to the battery power. This does not affect the monitor’s operating status.

PIN ID CN1 CN2


AC input socket To DC board
Description
socket
Working voltage 100-250V(AC) 15V
Module Function Supply power to DC power Board ,

3.2.5 Button Board

The button board, located at the lower part of the monitor’s front panel, button board including knob that can
be pressed, knob can also be rotated both clockwise and counter-clockwise, signals are sent to main board
CPU by the single chip processor on button board. It also controls display of power indicator, AC indicator
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and charge indicator.

PIN ID J4 PIN ID J4
To main board KEY1 To main
Description Description
board KEY1
Working voltage 19V,12V,5V Working voltage 19V,12V,5V

3.2.6 LCD Connect board

PIN ID J1 J2 J3
Description To mainboard J29 LCD screen socket LCD screen nright socket
Working voltage 12V,5V,3.3V / 12V

3.2.7 SPO2 Module

There are 3 types of SPO2 modules: Analog SpO2, Masimo SpO2 and Nellcor SpO2 module.
The SpO2board implementsSpO2signals collection, amplified simulation, relative digital/analog conversion
and signal processing.
The pulse extent of optical signal changes during monitoring. SpO2 parameter, pulse rate signal and pleth
waveform will be acquired after calculation. These data will be transmitted to the main board with special
communication protocol.

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3.2.8 Analog SPO2 Module

PIN ID Interface socket


Description To 7-parameter SPO2 socket
Working voltage 5V

3.2.9 MASIMO SPO2 Module

PIN ID Interface socket


Description To 7-parameter SPO2 socket
Working voltage 5V

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3.2.10 NELLCOR SPO2 Module

PIN ID J4 J5
Description To 7-parameter SPO2 socket To 7-parameter SPO2 socket
Working voltage 5V 5V

3.2.11 7 Parameter 12-Lead ECG Board

The ECG module includes 12 leads ECG monitoring part and TEMP monitoring part.

PIN ID J7 J8
Description To 7-parameter board J12 To side panel J5
Working voltage 5V 5V

3.2.12 IBP Board

IBP module measures invasive blood pressure.

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PIN ID J7 J8
To 7-parameter board IBP To 7-parameter board IBP
Description
socket J8/J9 socket J8/J9
Working voltage 5V 5V

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Chapter 4 Troubleshooting

4.1 Introduction

In this chapter, patient monitor problems are listed along with possible causes and recommended corrective
actions. Refer to the tables to check the patient monitor, 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 International After-sale Dept.

4.2 Part Replacement

Printed circuit boards (PCBs), major parts and components in the patient monitor are replaceable. Once you
isolate a PCB you suspect defective, follow the instructions in Chapter 7Disassembly Procedure to replace
the PCB with a known good one and check that the trouble disappears or the patient monitor passes all
performance tests. If the trouble remains, exchange the replacement PCB with the original suspicious PCB
and continue troubleshooting as directed in this chapter. Defective PCB can be sent to us for repair. To
obtain information on replacement parts or order them, refer to Parts 6.

4.3 Patient Monitor Status Check

Some troubleshooting tasks may require you to identify the hardware version and status of your patient
monitor.

4.4 Software Version Check

Some troubleshooting tasks may require you to identify the configuration and software version of your
patient monitor
●To view information on the system configuration and system software version, Select[Main Menu] →
[Maintain] password“5188”Monitor Info.

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4.5 Technical Alarm Check

Before troubleshooting the patient monitor, check for technical alarm message. 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 patient monitor’s User Manual.

4.6 Troubleshooting Guide

4.6.1 Power On/Off Failures

Symptoms Possible Cause Corrective Action


Check that AC power is properly
AC power cable not connected
connected
Check that the battery capacity is
The battery capacity is too low
sufficient.
The patient monitor fails 1. Check that cables from button board to
to start (AC LED or Mother board and power module to
Cables defective or poorly
battery LED does not Mother board are correctly connected.
connected 2. Check that cables and connectors are
light)
not damaged
KEY board is broken Replace the KEY board
LCD Connector board defective Replace LCD Connector board
Power module is defective Replace the power module
Reconnect the cable from Motherboard to
The cables Defective or poorly
key board and reconnect the cable from
connected
The patient monitor fails power module to the Motherboard
to start.(AC LED or Key board is Defective Replace the key board
battery LED lighting) LCD connector board defective Replace LCD connector board
Power module is defective Replace the power module
Motherboard is Defective Replace the Motherboard

4.6.2 Display Failures

Symptoms Possible Cause Corrective Action

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1.Check that cables from the LCD to the
Motherboard and from the LCD
Cables connected Motherboard
adapter board to the button
with LCD screen defective or
board/display are correctly connected.
connected poorly
2. Check that the cables and connectors
Integrated display is
are not damaged.
blank but the patient
Adapter board or its cables Replace the adapter or reconnected the
monitor still works
defective cables
Screen is defective Replace the Screen.
LCD connector board defective Replace LCD connector board
Motherboard is defective Replace the Motherboard
Power module is defective Replace the power module.

1.Check that the cable between the key


board and the Motherboard is correctly
connected.
Cables defective or poor 2. Check that the cables between inverter
connected. and key board are correctly connected.
Integrated display is 3. Check that the cable between the power
blank and the patient board and Motherboard is correctly
monitor does not work connected.

The LCD connector board is


Replace the LCD connector board
defective
The power board is defective Replace the power board
Motherboard is defective Replace the Motherboard
The screen is defective Replace the LCD screen
Check that the cable between the display
Cables defective or are poorly
and the Motherboard is correctly
connected.
LCD Screen displays connected.
splash or flashing The LED inverter board is
Replace the LED inverter board
specks defective
The Motherboard is defective Replace the Motherboard
The screen is defective Replace the screen

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4.6.3 Battery Problem

Symptoms Possible Cause Corrective Action


Recharge the battery for about 4 hours,
check out how long it can operate and
Battery is defective check out its voltage with a multimeter
Please refer to our international after sales
Dept about the exact values.

Battery can’ t be recharge Check that Contact Springs between


Contact Springs defected or
battery and power module is well
poorly connected
contacted.

Power board failures Replace power board


The Mother board is
Replace the Mother board
defective

4.6.4 Touch screen Failures

Check if screen is locked. If yes, long


Touch screen disabled press the MAIN MENU key to unlock
the Touch screen.

Check the cables between the Button


Cables defective or poorly
Touch screen does not respond board and Motherboard are correctly
connected
connected.

Button board defective Replace the button board


Touchscreen defective Replace the touchscreen
Motherboard defective Replace the Motherboard
Calibrate the touchscreen. You can refer
Touchscreen not calibrated
to the user manual.
Touch position is invalid
Touchscreen defective. Replace the touchscreen

4.6.5 ECG failures

Symptoms Possible Cause Corrective Action

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ECG setup way is wrong Check the ECG channel or Lead Type setting

ECG cable is defective or is not Replace the ECG detector or reconnect the
connected well electrodes.
Clean the skin and paint certain electrode
The skin of patient is dry
The ECG cream

Parameter or The connection between the


Check the connector of 7-parameter board
waveform ECG board and 7-parameter
whether the Pins have been damaged or bended
signals cannot be board

detected or The cable from the ECG module


Check the cable from ECG module to side plate
incorrect to side plate socket is not
socket and reconnect them.
connected well

ECG module defective Replace the ECG module

Motherboard defective Replace the Motherboard

7-parameter board defective Replace the 7-parameter module

The connection between


Check the Pins of 7-parameter board no
7-parameter board and side plate
damage or bend
board fails
ECG No baseline
ECG module defective Replace the ECG module

Motherboard or 7- parameter
Replace the Motherboard or 7- parameter board
defective
ECG setting is something wrong Set the ECG setting in the filter options
The monitor does not connect to
Connect the grounding cable to the right place
grounding
The side plate board is not
connected well with the Reinstall the boards
ECG waveform has 7-parameter board
interference The cable from the ECG module
Check the cable from ECG module to side plate
to side plate socket is not
socket and reconnect them
connect well
Disturbed by some electronic Remove some electronic devices from the
devices monitor
ECG module defective Replace the ECG module

HR value is ECG cable defective Replace the ECG accessories


incorrect The electrodes are connected Reconnect the electrode

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poorly
Check the settings on ECG menu according the
System settings incorrect
user manual guide
ECG module defective Replace the ECG module
Motherboard defective Replace the Mother board

4.6.6 SPO2 Failures

Symptoms Possible Cause Corrective Action


The SPO2 probe is defective Replace the SPO2 probe
The connection between the SpO2
Check the Pins of 7-parameter module no damage
module and 7-parameter module
or bend
The SpO2 no poorly connected
waveform The connection between the
Check the Pins of 7-parameter module no damage
and value 7-parameter module and side plate
or bend
board poorly connected
SPO2 module is defective Replace the SPO2 module
Motherboard is defective Replace the Motherboard
The probe type of SpO2 sensor is
Change a right probe type of patient
wrong
Long time measurement of NIBP on
SpO2value
the same limb or some other Start the SPO2 measurement in a normal state
is incorrect
condition such as shock or low temp
SPO2 module is defective Replace the SPO2 module

Motherboard is defective Replace the Motherboard

4.6.7 NIBP Failures

Symptoms Possible Cause Corrective Action

The cable from the pump to


7-parameter module is poorly Reconnect the cable
Can’t start air connected
inflation Check the hotkey to see if is working or not,
The keyboard is defective then confirm the problem is no key board,
replace it for testing

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The tube from pump to side plate Check the tube to see if it’s disconnected or
board disconnected broken
7-parameter module defective Replace the NIBP module
Pump defective Replace the pump
Mother board is defective Replace the Motherboard
Check out the type of the patient in the patient
The type of the patient is wrong
management
Inflation
Check out the cuff ,the NIBP tube or the
repeatedly but no The accessories have air leakage
interface socket
results
The pump or air valve defective Replace the pump or air valve
7-parameter defective Replace the 7-parameter board
Check out the type of the patient in the patient
The type of the patient is wrong
management
A continue NIBP measurement for The measurement should start every 5 minutes
The NIBP values a Long time at least
are incorrect 1.The cuff has leakage or is defective
The cuff or tube air leakage
2. The NIBP tubing has leakage
The NIBP module is defective Replace the NIBP module
The Mother board is defective Replace the Mother board

4.6.8 RESP Failures

Symptoms Possible Cause Corrective Action


RESP function is disabled Enable the ECG module in the module set up
ECG cable or electrode is defective Replace the ECG cable

The ECG Lead connected in wrong


Reconnect the electrodes
position
NO RESP
data The connection between ECG module
and 7-parameter module poorly Reinstall the modules
connected
ECG module defective Replace the ECG module
Motherboard defective Replace the Motherboard
RESP The signal of patient is so weak Check out the patient condition

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reading and The electrode or ECG cable are
Replace the ECG cable or electrodes
waveform defected
incorrect ECG module is defective Replace the ECG module

Motherboard is defective Replace the Motherboard

4.6.9 IBP Module Defective

Symptoms Possible Cause Corrective Action


IBP no The monitor is not equipped with IBP Check out whether the monitor configured with
readings and module IBP function
waveforms IBP module is disabled. Please enable the IBP module. For more details,
you can refer to the user manual.
The connection between IBP module 1. Check that the connection between IBP module
and 7-parameter module poorly and 7-parameter module.
connected 2. Check the Pins of 7-parameter module no bend
or damage
The connection from the 7-parameter Check Pins of 7-parameter module no bend or
module to side plate socket is not damage
connected well
IBP module is defective Replace the IBP module
Motherboard is defective Replace the Motherboard
IBP The settings are incorrect Check the settings on setup menu, ensure the
readings and channel you are operating is consistent
waveforms No Zero before operate Zeroing must be done before operate or after
are incorrect change a new sensor
The IBP module is defective Replace the IBP module

4.6.10 TEMP Module Defective

Symptoms Possible Cause Corrective Action


The temperature is lower than
Check out the TEMP is in the normal range
NO TEMP values the monitor can measure range
The TEMP probe is defective Change another TEMP probe

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The connection between the
Check if the ECG is working normal or not ,if
ECG module and 7-parameter
not, please reinstall the modules
board poorly connected
The connection from the
7-parameter module to side
Reconnect the 7-parameter module
plate socket is not connected
well
TEMP module is defective Replace the TEMP module
Motherboard is defective Replace the Motherboard
YSI or CF is compatible , choose the right type
The settings is incorrect
TEMP value is you are using

incorrect TEMP probe is defective Replace the TEMP probe

ECG module is defective Replace the ECG module

The TEMP socket defective Check out whether it has a bad contact

Temperature display The TEMP probe defective Change a TEMP probe

is unstable The ECG module is defective Replace the ECG module

The Motherboard is defective Replace the Mother board

4.6.11 EtCO2 Failures

Symptoms Possible Cause Corrective Action


Accessories (sampling line or
Replace sampling line or airway adapter.
adapter) is defective

The extension cable is defective Replace the extension cable


NO EtCO2 The connection between
data and wave 7-parameter module and side plate Reinstall the 7-parameter module
board poorly connected
EtCO2 module is defective Replace the EtCO2 module
Motherboard is defective Replace the Motherboard
Reset the settings on menu as user manual guide,
Settings are incorrect
ETCO2 data zeroing must be done before each use

and parameter Sampling line or Airway adapter is Replace the disposable sampling line or airway

is inaccurate defective adapter

EtCO2 module is defective Replace the EtCO2 module

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4.6.12 Button and Knob Failures

Symptoms Possible Cause Corrective Action


Cable defective or poorly Check that cable between button board and
connected power supply board is properly connected.
Buttons do not work
Use the hotkey to confirm if the monitor is
Button board failure
working, then replace the button board

Knob failures Replace the knob

Knob does not work Keyboard or flexi cable is


Replace the keyboard or flexi cable
defective
Main board is defective Replace the main board

4.6.13 Recorder Failures

Symptoms Possible Cause Corrective Action


Paper reversed Re-install the paper roll.
The record door does not close
Check out door and indicator light
well
The type of paper is wrong Install the right paper
1. Check that cable between recorder
and Motherboard is properly
Cable defective or poorly
connected.
No printout connected
2.Check that connecting cables and
connectors are not damaged.

Check if the power module outputs 5


Recorder power
V DC and 12V DC correctly.(Please
supply failure
contact our International Service Dept.

Recorder failure Replace the recorder.


Paper roll not properly Stop the recorder and re-install the
installed paper roll.
Poor print quality
1. Check the thermal print head
Print head dirty
2. Clean the thermal print head with an
appropriate cleaning solution.

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Print head failure Replace the print head.

4.6.14 Software Upgrade Problems

Symptoms Possible Cause Corrective Action

Upgrade software is damaged Get new software from manufacturer

Check the software name to make sure


Software name incorrect there is not error ,specially the capital
System upgrade failure
words
“system tips”
Main board is defective Chang the main board

Use the incorrect software for patient


Software is incorrect
monitor

USB-stick defective or can’t


Chang the usb-stick for testing
be detected by patient monitor

Software is damaged or Check the software name or change the


incorrect name software

Fail to upgrade ”not system Check the software on another patient


tips” monitor to confirm if the usb-stick and
USB socket is damaged or
software no problem, then check the
internal cable defected
patient monitor usb socket and internal
cable

Main board is defective Replace the main board

4.6.15 Technical Alarm Messages

Please refer to the User manual.

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Chapter 5 Software Upgrade

The system software is able to be upgraded with the USB-stick through USB interface on monitor.

5.1 Tools

The following tools are required during the software upgrade:


 USB-stick 8GB(recommend)

5.2 Preparation before Upgrade System Software

1. Before software upgrade, please check software version and record it to make sure you are able to
revert back in case the failure of software upgrade.
2. Take a USB-Stick, the size of the USB Stick should be 2GB/4GB(recommend), format it to “FAT”
format before software upgrade;
3. Unzip the package file that got from us and copy the folder * to the root directory in USB-Stick, do not
change the folder name or the file name(s) in the folder unless you are informed by us to have the
necessary change.
4. The folder name should be “SOFTUPDATE” in capital.

5.3 System Software Upgrade

1. Connect the USB-Stick to the patient monitor;


2. Power on the patient monitor( you would see the software upgrade progress on screen);
3. Remove the USB-Stick and Power off the patient monitor when the software upgrade is done.
4. Restart the monitor and check the software version.

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-Stick during the software upgrade process.

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Chapter 6 Performance Verification

6.1 IBP test

6.1.1 IBP performance test

Tool required:MX960(medex)
Follow this procedure to perform the test.
1. Connect the patient simulator to IBP1 socket..
2. Click the IBP baseline on the screen, select “CH press set up”, set “ART” as CH1(arterial
pressure).Enter “SURVEY set up” menu, select IBP (1, 2) set up, select “IBP PRESSURE ZERO”,
select “CH1 ZERO”. Follow up the next step after screen display “IBP CH1 zero success”.
3. Press MX960 keypad continuously.
4. The IBP value show 100±1mmHg
5. Repeat the steps above for all the IBP channels.

6.1.2 IBP Pressure Calibration

1. Connect the patient simulator to IBP1 socket.


2. Click the IBP baseline on the screen, select “CH press set up”, set “ART” as CH1 (arterial pressure).
3. Enter “SURVEY set up” menu, select IBP (1, 2) setup, select “IBP PRESSURE ZERO”, select “CH1
ZERO”, set the CH1 pressure value as 100.
4. Press MX960 keypad straightly then click Channel 1Calibration.
5. The IBP value on the display will be “100” means the IBP calibration success, otherwise repeat below
operation.
6. Repeat the steps above for all the IBP channels.

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6.2 NIBP Test

6.2.1 NIBP Leakage Test

Tools required:
 NIBP cuff for adult patient
 Appropriate tubing
 Cylinder
Follow this procedure to perform the test:
1. Set [Patient type] to [Adult].
2. Connect the NIBP cuff with the NIBP socket on the monitor.
3. Apply the cuff to the cylinder as shown below.

4. Select [MAIN MENU]→ [MAINTAIN] →PASSWORD “5188” →[Leakage Test]. The


message[Leakage Testing…] is displayed in the NIBP parameter area.
5. The cuff automatically deflates after 20s, which means NIBP leakage test is completed.
If no message is displayed in the NIBP parameter area, it indicates that the system has no leakage. If the
message [NIBP Pneumatic Leak] is displayed, it indicates that the system may have a leakage. In this
case, check if all connections are good and the cuff and tubing have no leakage. Perform the test again
after making sure all connections are good and the cuff and tubing have no leakage.
You can either perform a manual leakage test:
1. Raise the pressure in the rigid vessel to 250 mmHg with the balloon pump. Then, wait for 5 seconds to
let the measured values becoming stable.
2. Record the current pressure value and meanwhile use a time counter to count time. Then, record the
pressure value after counting to 60s.
3. Compare the two values and make sure the difference should not be greater than 5 mmHg.

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6.2.2 NIBP Calibration

Tools required:
 T-shape connector
 Appropriate tubing
 Balloon pump
 Metal Vessel with volume 500 ± 25 ml
 Reference manometer (calibrated with accuracy equal to or greater than 1 mmHg)
Follow this procedure to perform a NIBP calibration:
1. Connect the equipment as shown below.

2. Before inflation, the reading of the manometer should be 0. If not, open the balloon pump to let the
whole airway open to the atmosphere. Close the balloon pump after the reading is 0.
3. Check the manometer values and the monitor values. Both should be 0mmHg.
4. Set [NIBP Pressure] to 150 mmHg in the [NIBP Measurement Circuit]. Raise the pump pressure to
150 mmHg. After the pressure value is stabilized, select the[Calibrate] button to start a calibration.
5. Set patient type to [Adult/Pediatric] in the [Overpressure Protection Circuit], and raise the pressure to
350 mmHg. After the pressure value is stabilized, select [Calibrate] to start a calibration.
6. Set the patient type to [Neonate] in the [Overpressure Protection Circuit], and raise the pressure to
165 mmHg. After the pressure value is stabilized, select [Calibrate] to start a calibration.
All calibration results are displayed in the [Calibrate NIBP] menu. If the calibration fails, check the test
system for leakage and perform another calibration.

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6.3 Sidestream and Mainstream CO2 Module Test

6.3.1 Accuracy Test

Tools required:
 A steel gas cylinder with 6±0.05% CO2 and balance gas N2
 T-shape connector
 Tubing
Follow this procedure to perform the test:
1. Plug the module into the module rack.
2. Wait until the CO2 module warm up is finished, and check the airway for leakage and perform a
leakage test as well to make sure the airway has no leakage.
3. In the [CO2] menu—->CO2setupselect [Zero].
4. Connect the test system as follows:

5. Open the relief valve to vent standard CO2 and make sure that there is an excess gas flow through the
T-shape connector to air.
6. Check the realtime CO2 value is within 6±0.05% in the [zero CO2] menu.

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6.4 AG Test

6.4.1 Leakage Test

Follow this procedure to perform the test:


1. Plug the AG module into the module rack.
2. Wait until the AG module warm up is finished and then use your hand or other objects to completely
block the gas inlet of the AG module. An alarm message [AC Airway Occluded] will appear on the
screen.
3. Block the gas inlet for another 30 s. If the alarm message does not disappear, it indicates that the
module does not leak

6.4.2 Accuracy Test

Tools required:
 Gas cylinder with 100% O2 and a certain standard gas (such as 6±0.05% CO2,Bal N2), or standard gas
mixture. Gas concentration should meet the following requirements : AA≥1.5%, CO2≥1.5%, N2O≥
40%, O2≥40%, of which AA represents an anesthetic agent. a/c≤0.01 (a is the gas absolute
concentration accuracy; c is the gas concentration)
 T-shape connector
 Tubing
Follow this procedure to perform the test:
1. Plug the AG module into the module rack.
2. Wait at least 10 min and then perform a leakage test to make sure the airway has no leakage.
3. Check if the fan inside the AG module works correctly.
4. Connect the test system as follows:

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5. Open the relief valve and vent a standard gas and make sure that there is an excess gas flow through the
T-shape connector to air.
6. Check that the concentration of each composition meets the specification stated in the Operator's
Manual.

6.4.3 Calibration

Tools required:
 Gas cylinder with a certain standard gas or mixture gas. Gas concentration should meet the following
requirements: AA≥1.5%, CO2≥1.5%, N2O≥40%, O2≥40%, of which AA represents an anesthetic
agent. a/c≤0.01 (a is the gas absolute concentration Accuracy c is the gas concentration).For 100% O2
calibration, a gas cylinder with 100% O2 is used and the O2 concentration is not less than 99%.
 T-shape connector
 Tubing
Follow this procedure to perform a calibration:
1. Check the airway and make sure that there are no occlusions or leaks. If the deviation is great, it indicates
that there is an occlusion in the tubing. Check the tubing for an occlusion.
 Perform a leakage test to make sure that the airway has no leakage.
Connect the test system as follows:

2. Open the relief valve and vent a certain standard gas or gas mixture and make sure that here is an excess
gas flow through the T-shape connector to air.
 If the difference between the measured gas concentration and the actual one is tolerable, a calibration is
not needed.
 If the difference is great, a calibration should be performed.

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6.5 ECG Test

6.5.1 ECG Performance Test

Tool required:
Fluke Medsim 300B, MPS450 or other patient simulator recommended
Follow this procedure to perform the test:
1. Connect the patient simulator with the ECG module using an ECG cable.
2. Set the patient simulator as follows: ECG sinus rhythm, HR=80 bpm with the amplitudes 1mV.
3. Check the ECG waves are displayed correctly without noise and the displayed HR values within
80 ± 1 bpm.
4. Disconnect each of the leads in turn and observe the corresponding lead off alarm message displayed on
the screen.
5. Set that the simulator outputs paced signals and set [PACE] to [ON] on the monitor’s patient manage
interface. Check the pace pulse marks on the monitor screen.

6.5.2 ECG Calibration

Tool required:
Vernier caliper
Follow this procedure to perform a calibration:
1. Select the 1st channel ECG waveform area→ [FILTER]→ [DIA].
2. Select [MAIN MENU]→ [MAINTAIN] →PASSWORD “5188” →[ECG Calibrate].
3. Select [ECG Calibrate]. A square wave appears on the screen and the message [CAL, can’t monitor]
is displayed.
4. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%.
5. After completing the calibration, select [STOP ECG CAL].
If necessary, you can print out the square wave and wave scale through the recorder and then measure the
difference.

6.6 RESP Performance Test

Tool required:
Fluke Medsim 300B, MPS450 or other patient simulator recommended
Follow this procedure to perform the test:

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1. Connect the patient simulator to the module using a non ESU-proof cable and set lead IIas the
respiration lead.
2. Configure the simulator as follows: lead II as the respiration lead, base impedance lineas 1500 Ω; delta
impedance as 0.5 Ω, respiration rate as 40 rpm.
3. Check the RESP wave is displayed without any distortion and the displayed RESP value is within 40 ±
1 rpm.6.1 Spo2 Test
Tool Required: None.

Follow this procedure to perform the test:

1. Connect SpO2 sensor to the SpO2 connector of the monitor. Set [Patient type.] to [Adu] on the monitor
and set [PR Source] to SpO2 on the monitor.
2. Measure SpO2 on your finger. (Assume that you stay healthy)
3. Check the PLETH wave and PR reading on the screen and make sure that the displayedSpO2 is within
95%-100%.
4. Remove the SpO2 sensor from your finger and make sure that an alarm of SpO2 Sensor Off is
triggered.

6.7 TEMP Test

Tool required:
Resistance box (with accuracy above 0.1Ω)
Follow this procedure to perform the test:
1. Connect the two pins of any Temp connector of a module to the two ends of the resistance box using 2
wires.
2. Set the resistance box to 1354.9Ω (corresponding temperature is 37ºC).
3. Verify each Temp channel of the monitor and make sure that the displayed value is within 37 ±
0.1ºC.You can also use a patient simulator to perform the Temp test.

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Chapter 7 Disassembly Procedure

The following section describes the disassembly and reassembly procedures for the monitor and its
components.

7.1 Who Should Perform Repairs

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 with power applied to the
instrument. Failure to adhere to this warning could cause serious injury or death.

Tools required:
 Screwdrivers
 Small flat head screwdriver
 Needle Nose Pliers
 ESD mat and wrist strap
 Cleaning Agent
 Tweezer

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7.2 Removing the Battery

1. Placed the device face upward, unscrew 2 KM3.0×5.0mm screws on the bottom to remove the battery;

KM3.0×5.0m

7.3 Separating the Front and Rear Housing

1. Remove the Battery as described in {HYPERLINK \l "_Removing_the_Battery"};


2. Pick out the rubber cap in the screw holes;
3. Unscrew the 6 PB3×10mm screws;

4. Unscrew the 2 PWM 3.0×8mm screws at the bottom of monitor;

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PWM 3.0×8mm

5. Unplug the cables that connect to the front panel to separate the front panel & rear housing.

Printer Frame

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7.4 Removing the Printer

1. Remove the Battery as described in {HYPERLINK \l "_Removing_the_Battery"};


2. Separate the front and rear housing as described in {HYPERLINK \l "_Separating_the_Front"};
3. Open the print cap then remove the two PWM 3.0×4mm screws;

4. Remove the printer cable which connects to main board (socket: J32)

Printer cable

7.5 Removing the Main Board

1. Removing the Battery as described in {HYPERLINK \l "_Removing_the_Battery"};


2. Separate the front and rear housing as described in {HYPERLINK \l "_Separating_the_Front"};
3. Disconnect the cables that connect to the main board;
4. Unscrew 4 M3.0×6.0mm screws to remove the main board;

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4*M3.0×6.0mm

7.6 Removing the LCD Control Board

1. Remove the Battery as described in {HYPERLINK \l "_Removing_the_Battery"};


2. Separate the front and rear housing as described in {HYPERLINK \l "_Separating_the_Front"};
3. Disconnect the cables that connect to the LCD Control Board;
4. Unscrew 4 M3.0×6.0mm screws to remove the LCD Control Board;

4*M3.0×6.0mm

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7.7 Removing the Knob Encoder and keyboard

1. Separate the front and rear housing as described in {HYPERLINK \l "_Separating_the_Front"};


2. Unplug the cap of knob (tip: you may use tweezers or other tool to pick out the cap);

Plug out the knob cap

3. Unscrew the screw nut on the Knob Encoder;

Unscrew the screw

4. Remove the cable from keypad;

5. Remove the 6 PWA 3.0×5.0mm screws from keypad.

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7.8 Removing the LCD Screen & Touchscreen

Caution:

 Do not touch the LCD & touchscreen panel


 Disassemble the LCD in an environment as dust-free as possible
 Touchscreen panel is fragile, be careful in installation or disassembly

1. Remove the Battery as described in {HYPERLINK \l "_Removing_the_Battery"};


2. Separate the front and rear housing as described in {HYPERLINK \l "_Separating_the_Front"};
3. Disconnect the cables from main board and LCD control board;
4. Unscrew 7 PA3.0×8.0mm screws and 2 PA3.0×5.0mm to remove the LCD Frame;

7* PA3.0×8.0mm

2* PA3.0×5.0mm

5. Remove the LCD screen;

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6. Remove the touch screen.

Touch screen
Panel

7.9 Removing the Alarm LED Board

1. Remove the Battery as described in {HYPERLINK \l "_Removing_the_Battery"};


2. Separate the front and rear housing as described in {HYPERLINK \l "_Separating_the_Front"}
3. Disconnect the cable that connects to the Alarm LED Board;
4. Pry up 4 locks to remove the alarm LED board.

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7.10 Removing 7-parameter Module & Side Panel Assembly

1. Remove the battery as described in {HYPERLINK \l "_Separating_the_Front"};


2. Separating the front and rear housing as described in {HYPERLINK \l "_Separating_the_Front"};
3. Disconnect cable on 7-Parameter module and CO2 cable from power supply board;
4. Unscrew 6 PA3.0×6.0mm screws from side panel and 2 PWA3.0×10.0mm screws from module
frame;

2 *PWA3.0×10.0mm

6 *PWA3.0×6.0mm

3. Unscrew the four PWA 3.0×6.0mm screws on the side panel and disconnect the Air hose to separate the
module frame and side panel;

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4*PWA 3.0×6.0mm

7.11 Removing 7-Parameter Board, ECG Board, NIBP Pump & Valves

Assembly

Separate Module Frame & Side Panel Assembly as described above;

7.11.1 Removing ECG Board

1. Turn the Module Frame to back side, then unscrew 4PA3.0×6.0mm screws to remove the ECG
board(take out the ECG board carefully, see red arrow pin connector)

4*PA3.0×6.0mm

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7.11.2 Removing 7-Parameter Board

Remove the ECG board before remove7-parameter board. Removing the pump & valves cable from the
socket, see the picture below, unscrew the 4 screws on the 7-Parameter Board to take to the board.

Pump & Valves


sockets

7.11.3 Removing NIBP Pump & Valves assembly

1. Disconnect the pump & valves cables from the socket as described above.

Pump & Valves


sockets

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2. Cut off the two cables ties that tied on the pump to remove the NIBP pump;
3. Unscrew the one 3×6mm screws on the valves fixed bracket, then remove the 2 NIBP valves.

Binding tape

Fixed bracket
for valves

7.12 Removing IBP Board, Masimo/Nellcor/ Analog SPO2 Board

Remove 7-Parameter Board as described above;

7.12.1 Removing IBP Board

The IBP board is attached on the 7-parameter board, unscrew the 3 screws on the IBP board to remove it.

IBP Board

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7.12.2 Removing Masimo/Nellcor/ Analog SPO2 Board

1. Weld off the shield box ;

SPO2 Shield

2. Unscrew the 2 screws on the SPO2 board to remove the board.

The position of
SPO2 board

7.13 Removing the Monitor Handle

1. Separate the front and rear housing as described in {HYPERLINK \l "_Separating_the_Front"};


2. Unscrew the 2 PWM3×10mm screws on the top of rear shell;

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PWM3×10mm

3. Pull out the Monitor Handle with 3N horizontal force.

Pull out with 3N horizontal force

7.14 Removing the DC Power Supply Module Assembly

1. Remove the battery as described above;


2. Separate the housing as described above;
3. Disconnect the wires from DC power supply board;
4. Unscrew the 2 PWM 3.0×6.0mm screws from the bottom of device

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2 PWM 3.0×6.0mm

5. Take out the DC Power Supply Assembly horizontally , then unscrew 4 PM 3.0×6.0mm screw to
remove it from battery compartment;

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7.15 Removing the AC Power Supply Module

1. Remove the battery as described above;


2. Separate the housing as described above;
3. Remove the module frame as described above;
4. Disconnect the wires from AC power supply board;
5. Unscrew the 4 PA 3.0×6.0mm screws to remove the AC power supply board;

4* PA 3.0×6.0mm

7.16 Remove the interface board

1. Remove the battery as described above;


2. Separate the housing as described above;
3. Remove the module frame as described above;
4. Disconnect the wires from Interface board;
5. Unscrew the 2 PA 3.0×6.0mm screws to remove the Interface Board;

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2* PA 3.0×6.0mm

7.17 Removing the Fan

1. Remove the battery as described above;


2. Separate the housing as described above;
3. Remove the module frame as described above;
4. Disconnect the speaker cable and unscrew 2 PM3.0×6.0mm screw to remove the speaker;

2* PM 3.0×6.0mm

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