Patient Monitor

STAR8000

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.

I
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

II
 CONTENT
Chapter 1 Safety ........................................................................................................................................ 1
1.1 Safety Information......................................................................................................................... 1
1.1.1 Danger ............................................................................................................................... 1
1.1.2 Warning ............................................................................................................................. 1
1.1.3 Cautions ............................................................................................................................. 2
1.1.4 Notes.................................................................................................................................. 3
1.2 Equipment Symbols ...................................................................................................................... 3
Chapter 2 Warranty and Service ............................................................................................................. 5
2.1 Warranty Terms ............................................................................................................................. 5
2.2 What is excluded ........................................................................................................................... 5
2.3 Service Procedure .......................................................................................................................... 6
2.3.1 Fill in the Service Claim Form (SCF) ............................................................................... 6
2.3.2 Send COMEN the SCF and Select a Solution ................................................................... 6
2.3.3 Obtain the RMA Form ....................................................................................................... 7
2.3.4 Send the Parts to COMEN ................................................................................................. 7
2.3.5 Contact Information .......................................................................................................... 8
Chapter 3 Principle Introduction ............................................................................................................. 9
3.1 Star8000 System Principle Block Diagram ................................................................................... 9
3.2 Module Introduction ...................................................................................................................... 9
3.2.1 Main board (9G45) ............................................................................................................ 9
3.2.2 ECG Module.................................................................................................................... 10
3.2.3 7 Parameter NIBP Module .............................................................................................. 11
3.2.4 Power Supply Module ..................................................................................................... 12
3.2.5 Button Board ................................................................................................................... 13
3.2.6 SPO2 Module .................................................................................................................. 13
3.2.7 Analog SpO2 Module ...................................................................................................... 14
3.2.8 MASIMO SpO2 Module ................................................................................................. 14
3.2.9 NELLCOR SpO2Module ................................................................................................. 15
Chapter 4 Troubleshooting ..................................................................................................................... 16
4.1 Introduction ................................................................................................................................. 16
4.2 Part Replacement......................................................................................................................... 16
4.3 Patient Monitor Status Check ...................................................................................................... 16
4.4 Software Version Check .............................................................................................................. 16
4.5 Technical Alarm Check ............................................................................................................... 17
4.6 Troubleshooting Guide ................................................................................................................ 17

III
 4.6.1 Power On/Off Failures .................................................................................................... 17
4.6.2 Display Failures ............................................................................................................... 17
4.6.3 Battery Failures ............................................................................................................... 18
4.6.4 ECG Failures ................................................................................................................... 19
4.6.5 SpO2 Failures ................................................................................................................... 20
4.6.6 NIBP Failures .................................................................................................................. 20
4.6.7 RESP Failures ......................................................................................................................... 21
4.6.8 IBP Module Defective ......................................................................................................... 22
4.6.9 TEMP Module Defective..................................................................................................... 23
4.6.10 EtCO2 Failures ................................................................................................................... 23
4.6.11 Button and Knob Failures .................................................................................................. 24
4.6.12 Recorder Failures .............................................................................................................. 24
4.6.13 Network Related Problems ................................................................................................ 25
4.6.14 Software Upgrade Problems .............................................................................................. 26
4.6.15 Technical Alarm Messages................................................................................................ 26
Chapter 5 Software Upgrade .................................................................................................................. 27
5.1 Tools ............................................................................................................................................ 27
5.2 Preparation before Upgrade System Software............................................................................. 27
5.3 System Software Upgrade ........................................................................................................... 27
Chapter 6 Performance Verification ...................................................................................................... 28
6.1 IBP Test ....................................................................................................................................... 28
6.1.1 BP \Performance Test ...................................................................................................... 28
6.1.2 IBP Pressure Calibration ................................................................................................. 28
6.2 NIBP Test .................................................................................................................................... 28
6.2.1 NIBP Leakage Test .......................................................................................................... 28
6.2.2 NIBP Calibration ............................................................................................................. 29
6.3 Sidestream and Mainstream CO2 Module Test ........................................................................... 30
6.3.1 Accuracy Test .................................................................................................................. 30
6.4 ECG Test ..................................................................................................................................... 31
6.4.1 ECG Performance Test .................................................................................................... 31
6.4.2 ECG Calibration .............................................................................................................. 31
6.5 RESP Performance Test............................................................................................................... 32
6.6 TEMP Test ................................................................................................................................... 33
Chapter 7 Disassemble Procedure.......................................................................................................... 34
7.1 Who Should Perform Repairs...................................................................................................... 34
7.2 Removing the Battery.................................................................................................................. 35

IV
7.3 Separating the Front and Rear Housing....................................................................................... 35
7.4 Removing the Recorder ............................................................................................................... 36
7.5 Removing the Button Board ........................................................................................................ 36
7.6 Removing the Knob Encoder ...................................................................................................... 37
7.7 Removing the LCD Screen.......................................................................................................... 37
7.8 Removing the Alarm LED Board ................................................................................................ 38
7.9 Removing the 7 Parameter NIBP Board...................................................................................... 39
7.10 Removing Main Board ................................................................................................................ 39
7.11 Removing the SpO2 Module Assembly ....................................................................................... 40
7.12 Removing the Power Supply Module.......................................................................................... 41
7.13 Removing the Speaker and Side Panel ........................................................................................ 42

V
Blank page

VI
 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 electro surgery 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 or 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 designated 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

The application part of Type

CF has the defibrillator-proof Production Date Mark
function

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 Multifunctional socket

lamp

3
 Battery charging indicator
Nurse calling socket
lamp

DVI interface
SD card interface

Synchronous interface for

defibrillation Main menu (reserved)

USB interface Offset calibration (reserved)

2. Packaging Symbols

Up Limit of stacking layers

Fragile Rainproof

4
 Chapter 2 Warranty and Service

2.1 Warranty Terms

COMEN provides warranty for the device (main unit) and 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.

5
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.

6
 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.

7
 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
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)

8
 Chapter 3 Principle Introduction

3.1 Star8000 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.
The bottom board is in charge of connections and communications with other internal modules

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 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 19 V,12V,5V
J4 Key2 socket 19 V,12V,5V
J32 Printer socket 18V,5 V
P7 WIFI socket 3.3V
J7 Alarm socket 5V
J6 Touch screen socket /
J8 LCD bright socket 12V,5V
J15 Touch screen socket /

3.2.2 ECG Module

The 7 parameter ECG board is a parameter measurement components, it provides the following functions:
1. 3 or 5 leads ECG and RESP measurement;
2. 2-channel TEMP measurement;
3. Data exchange with the 7 parameter NIBP module.

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 PIN ID J2 J3
Description To NIBP board To ECG interface panel
Working voltage 6.6V,5V,3.3V 5V
Module Function Measure ECG parameter

3.2.3 7 Parameter NIBP Module

The 7 parameter NIBP board is a parameter measurement components, it provides the following functions:
1. NIBP measurement;
2. SpO2 installation place;
3. IBP installation place;
4. Data exchange with the main board through the serial ports.

PIN ID J1 J2 J5 J8 J9 J10 J11 J12 J15

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 NIBP NIBP To IBP IBP To 7Paramete To CAS
pump valves SpO2 socket socket IBP r ECG NIBP
Descripti
socket socket interfa interfac communic board socket
on
ce e panel ation
panel socket
12V 12V 3.3V 12V,5 5V 5V 12V,5V 6.6V, 12V
Working
V 5V,3.
voltage
3V
Module Measure NIBP, SpO2, IBP, parameter
Function

3.2.4 Power Supply Module

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.
The AC 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.

12
 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 mainbo speaker socket USB/NET socket
Description
socket socket socket ard socket board
socket socket
100-250 15V 15V 15 V,12 / 5V 5V,1.8v 16.8V
Working
V(AC) V,5V,1.
voltage
8V
Module Provide power to main board
Function

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
and charge indicator.

PIN ID J3 J1
Description Button FFC socket Knob socket
Working voltage 18V,12V,5V 5V
Module Function keyboard signal process and sending

3.2.6 SPO2 Module

There are 3 types of SpO2 modules: Digital SpO2, Masimo SpO2 and Nellcor SpO2 module.
The SpO2 board implements SpO2 signals 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

13
communication protocol.

3.2.7 Analog SpO2 Module

PIN ID J1 J2
Description SPO2 Power Socket SPO2 Power Socket
Working voltage 5V 5V
Module Function Measure SPO2 parameter

3.2.8 MASIMO SpO2 Module

PIN ID J1 J2
Description SPO2 Power Socket SPO2 Power Socket
Working voltage 5V 5V

Module Function Measure SPO2 parameter

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3.2.9 NELLCOR SpO2Module

PIN ID J4 J5
Description SpO2 Power Socket SpO2 Power Socket
Working voltage 5V 5V
Module Function Measure SpO2 parameter

15
 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 7 Disassembly 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

AC power cable not connected Check that AC power is properly connected
and the battery capacity is too and check that the battery capacity is
low sufficient.
Use a Multi-meter to check it out, if you
Fuse(s) is (are ) broken don’t know how to use, please refer to our
The patient monitor fails International Service Dept.
to start (AC LED or
1. Check that cables from button board to
battery LED does not
Cables defective or poorly power module properly connected.
light)
connected 2. Check that cables and connectors are not
damaged.

KEY board is defective Replace the KEY board

Power module is defective Replace the power module

The cable between power

The patient Monitor fails supply board to keyboard Check this cable to see if it’s connected well

to start.（AC indicator or defective

battery indicator are Key board is Defective Replace the key board

lighting） Power module is defective Reconnected the power module

Motherboard is Defective Replace the Motherboard

4.6.2 Display Failures

Symptoms Possible Cause Corrective Action

17
 1. Check that cables from the screen to the
Motherboard and from the screen adapter
Cables connected
board to the button board display are
Motherboard with screen
correctly connected.
defective or connected poorly
Integrated display is blank 2. Check that the cables and connectors are
but the patient monitor still not damaged.
works Adapter board or its cables Replace the adapter or reconnected the
defective cables
Screen is defective Replace the Screen.
Motherboard is defective Replace the Motherboard
Power module is defective Replace the power module.
Cables defective or poor Check the cable from power supply board to
Integrated display is blank
connected. main board, replace it if it’s defected
and the patient monitor
The power board is defective Replace the power board
does not work
Motherboard is defective Replace the Motherboard

Check that the cable between the display

Cables defective or are poorly
and the Motherboard(or inverter board) is
connected.
correctly connected.
Screen displays splash or
The screen inverter board is
flashing specks Replace the Screen inverter board
defective
The screen is defective Replace the screen
The Motherboard is defective Replace the Motherboard

4.6.3 Battery Failures

Symptoms Possible Cause Corrective Action

Recharge the battery for about 4 hours, check out
how long it can operate and check out its voltage
Battery is defective
with a multi-meter. Please refer to our international
Battery can’ t be
after sales Dept about the exact values
recharge
Cable defective or Check that cable between battery and power module
poorly connected is correctly connected.
Power board failures Replace power board
The Mother board is defective Replace the mother board

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4.6.4 ECG Failures

Symptoms Possible Cause Corrective Action

The settings of ECG is

Check the ECG channel or Lead Type settings
incorrect
ECG cable is defective or is
Replace the ECG detector or reconnect the electrodes
not connected well

The ECG The skin of patient is dry Clean the skin and paint certain electrode cream

Parameter or Cable from Mother board

waveform and ECG module does not

Check the cable from Motherboard to ECG module
signals cannot connect well with the

be detected or Motherboard

incorrect The cable from the ECG

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

ECG module is defective Replace the ECG module

Motherboard is defective Replace the Motherboard

Internal wire is loose or Check from Motherboard to ECG board and replace with

ECG No damage a new one and have a try

baseline ECG module defective Replace the ECG module

Motherboard defective Replace the Motherboard

ECG setting is incorrect Reset the ECG settings on ECG setup menu
The monitor does not
Connect the grounding cable to the right place
connect to grounding
ECG cable is not connected
Check the cable from Motherboard to ECG module
ECG well with the Motherboard
waveform has The cable from the ECG
Check the cable from ECG module to side plate socket
interference module to side plate socket
and reconnect them
is not connect well
Disturbed by some electronic
Remove some electronic machine from the monitor
machine
ECG module defective Replace the ECG module

HR value is External ECG cable is Replace the ECG accessories or change the HR source

19
incorrect damage or the HR channel is
wrong
The electrodes are connected
Reconnect the electrode
poorly
The wire between ECG
module and main board Reconnect the cable or replace it
poorly connected
ECG module defective Replace the ECG module
Motherboard defective Replace the Mother board

4.6.5 SpO2 Failures

Symptoms Possible Cause Corrective Action

The SPO2 probe is defective Replace the SPO2 probe

The cable from the SPO2 module to Check the cable from SPO2 module to side plate
side plate socket is not connect well socket and reconnect them

The SpO2 no 1. Check that the cable between the Motherboard

Cables from Motherboard to SPO2
waveform to the SPO2 module is correctly connected.
module are defective or poorly
and value 2. Check that the cables and connectors are not
connected.
damaged

SPO2 module is defective Replace the SPO2 module

Motherboard is defective Replace the Motherboard

The probe type of the patient is wrong Change a right probe type of patient
Long period of NIBP measurement
SpO2value on 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

4.6.6 NIBP Failures

Symptoms Possible Cause Corrective Action

20
 Cables from mother board to First, check that the cable between the motherboard to
NIBP module are defective or the NIBP module is correctly connected. Then, check
poorly connected. that the cables and connectors are not damage.

Can’t start air The keyboard defective Replace the Keyboard

inflation
The wire from the NIBP module Check the wire from NIBP module to air pump,
to air pump is not connected well replace it if it’s broken
NIBP module is defective Replace the NIBP module
Mother board is defective Replace the mother board
Check out the type of the patient in the patient
The NIBP settings are wrong
management
Inflate air
Check out the cuff ,the cuff pipe ,or the interface
repeatedly The accessories have air leakage
socket
(NO NIBP
Inflatable with numerical display, but the value is not
values ) The NIBP pump has air leakage
stable, it can be seen that the numeric declines
2in 1 functions board Replace the 2 in 1 functions board
Check out the type of the patient in the patient
The type of the patient is wrong
management
A continue NIBP measurement
The measurement should start every 5 minutes at least
The NIBP for a Long time
values are 1.The cuff is tied up too tight or too loose
The NIBP accessories have
incorrect 2.The cuff has leakage or is defective
leakage
3. The NIBP tubing has leakage
The NIBP module is defective Replace the NIBP module
The Mother board is defective Replace the Mother board

4.6.7 RESP Failures

Symptoms Possible Cause Corrective Action

The RESP is disabled Enable the RESP on setup menu
ECG cable or electrode is
Replace the ECG cable
defected
NO RESP
Cables from Motherboard to 1. Check that the cable between the Motherboard to the
data
ECG module defective or poorly ECG module is correctly connected.
connected. 2. Check that the cables and connectors are not damage
The cable from the ECG module Check the cable from ECG module to side plate socket

21
 to side plate socket is not and reconnect them
connected well
ECG module is defective Replace the ECG module
Motherboard is defective Replace the Motherboard
The signal of patient is so weak Check out the patient condition
RESP wave
The electrode is defective Replace the ECG probe
and reading
ECG module is defective Replace the ECG module
are
incorrect Motherboard is defective Replace the Motherboard

4.6.8 IBP Module Defective

Symptoms Possible Cause Corrective Action

The monitor is not equipped
Check out whether there is a IBP module in the monitor
with IBP module

Please enable the IBP module, For more details, you can
IBP module is disabled
refer to the user manual.
The IBP has Cables from Motherboard to 1. Check that the cable between the Motherboard to the
no readings IBP module are defective or IBP module is correctly connected.
and no poorly connected 2. Check that the cables and connectors are not damage.
waveforms The cable from the IBP module
Check the cable from IBP module to side plate socket
to side plate socket is not
and reconnect them
connect well
IBP module is defective Replace the IBP module
Motherboard is defective Replace the Motherboard
1. Zeroing must be done before use
2. Disposable IBP sensor must be change after single
The IBP settings are incorrect use
IBP readings 3. Ensure the channel you set is the channel you are
are incorrect using
The IBP extension cable or
Replace the extension cable or sensor
sensor is defected
The IBP module is defective Replace the IBP module

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4.6.9 TEMP Module Defective

Symptoms Possible Cause Corrective Action

The temperature is lower
than the monitor can Check out the TEMP is in the normal range
measure range
The TEMP probe is
Change another TEMP probe
defective
Cables from Motherboard to 1. Check that the cable between the Motherboard to
NO TEMP values ECG module are defective or the ECG module is correctly connected.
poorly connected 2. Check that the cables and probe are not damage
The cable from the ECG
Check the cable from ECG module to side plate
module to side plate socket
socket and reconnect them
is not connected well
TEMP module is defective Replace the TEMP module
Motherboard is defective Replace the Motherboard
The type of temp sensor is it can supports CF and YSI, change the setting you
incorrect need
TEMP value is
incorrect TEMP probe is incorrect Replace the TEMP probe

ECG module is defective Replace the ECG module

The TEMP socket defective Check out whether it has a bad contact
The TEMP probe defective Change a TEMP probe
TEMP Value The ECG module is
Replace the ECG module
unstable defective
The Mother board is
Replace the Mother board
defective

4.6.10 EtCO2 Failures

Symptoms Possible Cause Corrective Action

NO EtCO2 Accessories (sampling line Replace sampling line or airway adapter.
readings and wave or adapter) is defective

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 Cables from Motherboard to 1. Check that the cable between the Motherboard to
side plate connector poorly the side plate connector is correctly connected.
connected 2. Check that the cables and connectors are not
damage
The cable from the Check the cable from EtCO2module to side plate
EtCO2module to side plate socket and reconnect them
socket is not connected well
EtCO2module is defective Replace the EtCO2module
Motherboard is defective Replace the Motherboard
EtCO2 readings or EtCO2 sampling line or air Replace the EtCO2 probe
wave are incorrect adapter is defective
EtCO2module is defective Replace the EtCO2module
Motherboard is defective Replace the Motherboard

4.6.11 Button and Knob Failures

Symptoms Possible Cause Corrective Action

Check that cable between button board
Cable defective or poorly connected
Buttons do not work and Motherboard is properly connected.

Button board failure Replace button board.

1. Check that cables from knob to button

board, and button board to Motherboard
Cable defective or
are properly connected
poorly connected
2. Check that connecting cables and
Knob does not work
connectors are undamaged.
Knob failures Replace the knob
Button board failure or knob board is Button board malfunctions. Replace the
defective button board

4.6.12 Recorder Failures

Symptoms Possible Cause Corrective Action

Paper reversed Re-install the paper roll.
No printout The record door does not close Check out door and indicator light
well (green is the working status)

24
 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.
connected
2. Check that connecting cables and
connectors are not damaged.
Check if the power module outputs 5 V
Recorder power DC and 12V DC correctly, if no,
supply failure reconnect the cable or change the main
board
Recorder failure Replace the recorder.
Paper roll not properly Stop the recorder and re-install the
installed paper roll.

1. Check the thermal print head

Poor print quality Print head dirty
2. Clean the thermal print head with an
appropriate cleaning solution.
Print head failure Replace the print head.
Recorder failure Replace recorder.
paper feeding not improperly Reloading the paper
Paper jam
Recorder defected Replace the paper

4.6.13 Network Related Problems

Symptoms Possible Cause Corrective Action

Can’t communicate with CMS, Inner network cable defective 1. Reconnect the network cable
indicator of RJ45 port is not or poor connection 2. Replace the network cable
illuminated or flashing
JR45 Connector problem Replace the connector

AP adapter/router is defected Replace the AP adapter or router

Can’t communicate with CMS, Settings problem Reset the IP address and monitor
but connection is ok configuration according the user manual

Computer system compatible Install the right version of windows

problem system

25
 Monitor software problem Ensure the monitor’s software support
the CMS

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

System upgrade failure Software name incorrect there is not error ,specially the capital

“system tips” words

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
Check the software on another patient
Fail to upgrade ”not system
monitor to confirm if the usb-stick and
tips” USB socket is damaged or
software no problem, then check the
internal cable defected
patient monitor usb socket and internal
cable

Main board is defected Replace the main board

4.6.15 Technical Alarm Messages

Please refer to the User manual.

26
 Chapter 5 Software Upgrade

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

5.1 Tools

The following tools are required during the software upgrade:

 USB-stick 2GB/4GB(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 patient monitor;

2. Power on the patient monitor( you would see the software upgrade progress on screen);
3. When the software upgrade is done, Remove the USB-Stick and Power off the patient monitor;
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 BP \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）setup 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”, and 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.

6.2 NIBP Test

6.2.1 NIBP Leakage Test

Tools required:

28
 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.

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)
29
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.

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.
30
2. Wait until the CO2 module warmup 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
theT-shape connector to air.
6. Check the realtime CO2 value is within 6±0.05％ in the [zero CO2] menu.

6.4 ECG Test

6.4.1 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 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.

6.4.2 ECG Calibration

Tool required:

31
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 CAL]. 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.

6.5 RESP 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 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 line as 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 reading of SpO2 is within
95%-100%.
4. Remove the SpO2 sensor from your finger and make sure that an alarm of SpO2 Sensor Off is
triggered.

32
6.6 TEMP Test

Tool required:
Resistance box (with accuracy above 0.1Ω)
Follow this procedure to perform the test:
a) Connect the two pins of any Temp connector of a module to the two ends of the resistance box using 2
wires.
b) Set the resistance box to 1354.9Ω (corresponding temperature is 37ºC).
c) 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.

33
 Chapter 7 Disassemble 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 (other than server removal) 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

34
7.2 Removing the Battery

1. Open the battery compartment by removing the 4 screws on the back of monitor.
2. Disconnect the battery cable and then take out the battery as below shows.

7.3 Separating the Front and Rear Housing

1. Remove the Battery as described above;

2. Remove the 5 screws on the rim of rear panel;
3. Lay down the monitor and remove the 2 screws on the bottom of monitor;
4. Disconnect the cable between the power module and the main board;

35
7.4 Removing the Recorder

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Unplug the cable which connects to the printer inside the monitor:
4. Unscrew the two PWM 3.0×8mm screws inside the recorder and pull out the recorder:

2-screws

7.5 Removing the Button Board

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Disconnect the cables that connect the Button Board, unscrew the five PB3×5mm screws to dismantle
the Button Board

36
7.6 Removing the Knob Encoder

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Disconnect the cable on Knob Encoder;
4. Unplug the cap of knob (tip: stick some 3M double-side tape on cap, then unplug it by hand)
5. Unscrew the screw nut on the Knob Encoder:

Disconnect inner wire Remove cap Remove nut

7.7 Removing the LCD Screen

Caution:

 Do not touch the LCD panel

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

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Disconnect the cables on keyboard, alarm lamp board, LCD cable;

37
4. Unscrew the 7 screws to separate the LCD carefully from the front panel of the monitor show as
above;
5. Unscrew the 4 screws on top and bottom of LCD frame to separate the LCD carefully from the LCD
frame, as show below;

7.8 Removing the Alarm LED Board

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Disconnect the cable that connects to the Alarm LED Board, and then unscrew the two PA3×8mm
screws to remove the Alarm LED Board;

38
7.9 Removing the 7 Parameter NIBP Board

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Unplug the cables that connect to the 7 Parameter NIBP Board;
4. Unscrew four PM3×6mm screws to remove the 7 Parameter NIBP Board.

7.10 Removing Main Board

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Unplug the cables that connect to the Main Board;
4. Unscrew the four PM3×6mm screws on main board to remove the Main Board.

39
7.11 Removing the SpO2 Module Assembly

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Remove the 7 Parameter NIBP module as described above;
4. Remove the SpO2 module shield case, unscrews 2 screws on the back of the 7 parameter NIBP module,
you can take out the SpO2 module;

40
7.12 Removing the Power Supply Module

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Unplug the cables that connect to the Power Supply Module, and then unscrew the 6 PM3×6mm and
on the Power Supply Module;
4. After removed the DC power module, unscrew 4 screws on the AC power module, then you can remove
the AC power module;

41
7.13 Removing the Speaker and Side Panel

1. Remove the Battery as described above;

2. Separate the front and rear housing as described above;
3. Unscrew the 5 screws, you can take out the 7 parameter chassis and the side panel, unscrew the 2
screws, then you can separate the side panel and the 7 parameter chassis.
4. Unscrew the 2screws on speaker holder to remove the speaker.

42
43