Service Manual

C90/C30
PATIENT MONITOR

SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD

 Intellectual Property statement
SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. (hereinafter called Comen) 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 Comen.
Nor the rights of others. Comen does not assume any liability arising out of any infringements of
patents or other rights of third parties.
Comen 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 Comen 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: 1.0
Release time: Dec. 2012
@ 2012 Shenzhen Comen Medical Instruments Co., Ltd. All rights reserved.
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
 CONTENTS
Chapter 1 Introduction ........................................................................................................................................ 6
Responsibility of the Manufacturer ............................................................................................................. 6
Warnings and cautions ................................................................................................................................ 6
Chapter 2 Theory of Operation ............................................................................................................................ 7
2.1 Introduction ........................................................................................................................................... 7
2.2 System Connections............................................................................................................................... 7
2.2.1 Mounting the Patient Monitor..................................................................................................... 7
2.2.2 Connector for Peripheral Devices ............................................................................................... 7
2.3 Main Unit ............................................................................................................................................... 8
2.3.1 Input System ............................................................................................................................... 8
2.3.2 Output system ............................................................................................................................. 9
2.3.3 Processing and communications system ..................................................................................... 9
2.3.4 Power Management System...................................................................................................... 10
2.3.5 Parameter Module ..................................................................................................................... 10
Chapter 3 Testing and Maintenance .................................................................................................................. 18
3.1 Introduction ................................................................................................................................... 18
3.1.1 Test Equipment .................................................................................................................. 18
3.1.2 Test Report ......................................................................................................................... 18
3.1.3 Preventative Maintenance .................................................................................................. 18
3.2 Preventative Maintenance Procedures .......................................................................................... 18
3.2.1 Visual Inspection................................................................................................................ 18
3.3 Power On Test ................................................................................................................................ 19
3.4 Module Performance Tests ............................................................................................................ 19
3.4.1 ECG Test ............................................................................................................................ 19
3.4.2 RESP Performance Test ..................................................................................................... 19
3.4.3 SpO2 Test........................................................................................................................... 20
3.4.4 Temp Test ........................................................................................................................... 20
3.4.5 IBP Tests ............................................................................................................................ 20
3.4.6 C.O. Test ............................................................................................................................ 22
3.4.7 EtCO2 Test ......................................................................................................................... 22
3.4.8 AG Test .............................................................................................................................. 23
3.4.9 ICG Test ............................................................................................................................. 24
3.4.10 IOC Test ............................................................................................................................. 25
3.5 Touch-screen Calibration ............................................................................................................... 26
3.6 Recorder Check .............................................................................................................................. 26
3.7 Network Test .................................................................................................................................. 26
3.8 Battery check ................................................................................................................................. 26
3.9 Software version ............................................................................................................................ 27
Chapter 4 Testing and Maintenance .................................................................................................................. 28
4.1 Introduction ................................................................................................................................... 28
4.2 Part Replacement .......................................................................................................................... 28
4.3 Troubleshooting Guide................................................................................................................... 28
4.3.1 Power On/Off Failures ....................................................................................................... 28
4.3.2 Display Failures ................................................................................................................. 29
4.3.3 Power supply Failures ........................................................................................................ 29
4.3.4 Button and Knob Failures ................................................................................................... 30
4.3.5 Recorder Failures ............................................................................................................... 30
 4.3.6 ECG Failures ....................................................................................................................... 31
4.3.7 Comen SpO2 Failures ...................................................................................................... 32
4.3.8 NIBP Failures ...................................................................................................................... 32
4.3.9 Respiration Failures ............................................................................................................ 33
4.3.10 EtCO2 Failures .................................................................................................................... 33
4.3.11 Software Upgrade Failures ................................................................................................. 33
Chapter 5 Disassembling Procedure .................................................................................................................. 35
5.1 Who Should Perform Repairs ......................................................................................................... 35
5.2 Removing the modular boxes and C30 .......................................................................................... 35
5.3 Separating the Front and Rear Housing ......................................................................................... 36
5.4 Removing the Recorder ................................................................................................................. 38
5.5 Removing the Button Board .......................................................................................................... 38
5.6 Removing the Inverter board and Touch-screen Control board .................................................... 39
5.7 Removing the Touchscreen & LCD panel ....................................................................................... 39
5.8 Removing the Alarm LED Board: .................................................................................................... 41
5.9 Removing the Main Board ............................................................................................................. 42
5.10 Removing the DC Power Supply Board .......................................................................................... 42
5.11 Removing Modular Slot ................................................................................................................. 43
5.12 Removing the Multi-interface Board ............................................................................................. 44
5.13 Removing the Speaker and Fan...................................................................................................... 45
5.14 Removing the AC Power supply board........................................................................................... 45
5.15 Removing the Base Part ................................................................................................................. 46
5.16 Removing the battery .................................................................................................................... 47
5.17 Removing the Power ON/OFF button ............................................................................................ 48
5.18 Disassembling Procedure for C30 .................................................................................................. 48
Chapter 6 Electrical Safety Inspection ............................................................................................................... 57
6.1 Power Cord Plug ............................................................................................................................ 57
6.2 Device Enclosure and Accessories ................................................................................................. 57
6.3 Device Labeling .............................................................................................................................. 58
6.4 Earth Leakage Test ......................................................................................................................... 59
6.5 Patient Leakage Current................................................................................................................. 60
6.6 Mains on Applied Part Leakage...................................................................................................... 61
6.7 Patient Auxiliary Current................................................................................................................ 62
 Chapter 1 Introduction

Responsibility of the Manufacturer

COMEN considers only itself responsible for any effects on safety, reliability and performance of
the equipment if:
 Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by Comen and the electrical installation of the relevant room complies with
national standards, and the instrument is used in accordance with the instructions for use.
 To ensure safety and EMC, use only those Comen parts and accessories specified ofr use with
the monitor. If Non-Comen parts are used, Comen is not liable for any damage that these parts
may cause to the equipment.
 This document contains proprietary information which is protected by copyright. All rights
reserved.
 Reproduction, adaptation, or translation without prior written permission is prohibited, except
as allowed under the copyright laws.

Warnings and cautions

In this guide:
 A warning alerts you to a potential serious outcome, adverse event or safety hazard, Failure
to observe a warning may result in death or serious injury to the user or patient.
 A caution alerts you where special care is necessary for the safe and effective use of the
product. Failure to observe a caution may result in minor or moderate personal injury or
damage to the product or other property, and possibly in a remote risk of more serious
injury.
 Chapter 2 Theory of Operation

2.1 Introduction

This patient monitor is designed to monitor a fixed set of physiological parameters including ECG,
heart rate(HR), respiration(RESP), temperature(TEMP), SpO2, pulse rate(PR), non-invasive blood
pressure(NIBP), invasive blood pressure(IBP), cardiac output(C.O.), anesthetic gas(AG), impedance
cardiograph(ICG), depth of anesthesia (IOC).
The patient monitor also:
 Provides audible and visual alarm indications in case of patient or equipment problems.
 Enables displaying, reviewing, storing and transferring of real-time data.
 Incorporates multiple input devices such as buttons, knob, touch screen.
 Enables program upgrade over the network
 Interfaces a clinical information system or central monitoring system

2.2 System Connections

2.2.1 Mounting the Patient Monitor

The patient monitor can be mounted on a wall bracket or on a trolley support. The wall bracket or
trolley support can be ordered optionally. Each type of mounting bracket is delivered with a
complete set of mounting hardware and instructions. Refer to the documentation delivered with the
mounting hardware for instructions on assembling mounts.

CUATION

 Use mounting brackets we supply or approve. If other compatible mounting bracket is used,
be sure it can be safely used on the patient monitor.
 The mounting bracket should be installed by our qualified service personnel, or engineers
who have adequate knowledge on it.
 If other mounting solution is used, the installation personnel and the customer should verify
if it can be safely used on the patient monitor, and the customer assume the responsibility
for any risk resulting from that

2.2.2 Connector for Peripheral Devices

On the back of patient monitor you will find all the connectors for peripheral devices.

1. AC Power Connector: used to connect an AC power source(100 to 240 VAC,50/60Hz).

2. Equipotential Terminal: used to connect the equipotential terminal of other equipment
eliminating potential difference between different pieces of equipment.
 3. Video Output: It is used to connect to the secondary display.
4. Network Connector: It is a RJ45 connector used to connect an Ethernet network or a PC(for our
CMS).
5. USB Connector: used to connect USB-disk for upgrade system or transferring data.
6. RS232 Connector: used to connect with PC for R&D use.
7. Nurse Call Connector: used to connect with nurse call devices.

2.3 Main Unit

 The patient monitor consists of:

 Input system: button board, knob, touch screen, power switch and LED board.
 Output system: LCD panel, alarm LED board, recorder and speaker
 Processing and communications system: main board and function boards
 Power management system: battery, battery interface board and power module
The following diagram illustrates the structure of the patient monitor

Battery
Power supply Function board

Recorde Network
r
Main board
USB Card Nurse call
ARM

SD Card

Touch screen LCD Screen

Key board

Alarm lamp LED indicator knob Inverter

2.3.1 Input System

Button board
The button board, located at the lower part of the monitor‟s front panel, contains 5 keys and
provides connections for the following components to the main board:
 Knob
 Power switch and LED board
 Alarm LED board
Knob
The knob can be pressed, or rotated both clockwise or counter-clockwise. it is connected with the
Button board.
Power switch and LED Board
The power switch and LED board controls the power supply for the main unit. It has three LEDs,
which respectively indicate the AC power status and battery status . it is connected with the button
board.
 2.3.2 Output system

LCD
The patient monitor adopts a high-resolution LCD. The LCD is connected with main board. The
signals from the main board and the power supply from the power supply board via inverter board.
Alarm Lamp
The patient monitor has two alarm lamps; alarm lamp and technical alarm lamp. Alarm lamp lights
either red or yellow whereas technical alarm lamp lights yellow only. The alarm lamp signals are
transferred by the button board and are directly controlled by main board.
Recorder
The recorder receives data from main board and then sends them to the thermal print-head for
printing. The recorder has a hard-key(start/stop record) and two LEDs on its front panel. Red LED
signify malfunction or no paper, green LED signify working properly. It is connected with main
board.
Speaker
The speaker provides sound or alarms, key strokes, heart beats and pulse, and allows pitch tone and
multi-level tone modulation . it is connected with the power supply board and directly driven by the
main board.

2.3.3 Processing and communications system

Main board
The main board is the heart of the patient monitor. It implements a series of tasks including input
and 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 following diagram shows
interfaces to the other components

The Core Board(ARM board) is an essential CPU system containing the CPU,FLASH, memory,
real-time clock, EEPROM, etc. It interfaces to the bottom board only. Which then provide
interfaces to all the other external devices.
The bottom board is in charge of connections and communications with other components and
provides the following interfaces:
Name Description
LCD connector Connects the built-in display
Parameter module connector Connects the parameter
boards(including NIBP board,SpO2
board, ECG board)
Recorder connector Connects the recorder
Touch screen connector Connects the touch screen
Power supply board connector Connects the power supply board
ARM board Connects the ARM board
USB connector Connects the USB connector
Video output Connects the video interface board
Network card connector Connects the network card assembly

The connection type of power extension socket spigots of the module of the new Monitoring
Baseboard + New Core Board is shown as follows:
2.3.4 Power Management System

Battery
The patient monitor uses one chargeable lithium-ion battery. The battery compartment is located at
the bottom of the patient monitor. The battery power is supplied to the main board via power supply
board. The capacity of battery is 4000mAh, 14.8V.
Power supply board
The power supply board is located at the back of the patient monitor. The power supply board
contains charging and power management, AC transforming board and DC transforming board.
The power supply board converts the input power into DC power supplies and then distributes them
to each component of the patient monitor. The input power comes from either the battery or an 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.
The power supply board protects itself and the patient monitor by switching off Ac input or DC
output in case of over-current, short circuit and overvoltage. The power supply board provides 3 DC
outputs +3.3V ,+5.0V +12V.

2.3.5 Parameter Module

NIBP Module
The oscillometric method was first demonstrated in 1876 and involves the observation of
oscillations in the sphygmomanometer cuff pressure which are caused by the oscillations of blood
flow, i.e., the pulse. The electronic version of this method is sometimes used in long-term
measurements and general practice. It uses a sphygmomanometer cuff, like the auscultatory method,
but with an electronic pressure sensor (transducer) to observe cuff pressure oscillations, electronics
to automatically interpret them, and automatic inflation and deflation of the cuff. The pressure
sensor should be calibrated periodically to maintain accuracy.
Oscillometric measurement requires less skill than the auscultatory technique and may be suitable
for use by untrained staff and for automated patient home monitoring.
The cuff is inflated to a pressure initially in excess of the systolic arterial pressure and then reduced
to below diastolic pressure over a period of about 30 seconds. When blood flow is nil (cuff pressure
exceeding systolic pressure) or unimpeded (cuff pressure below diastolic pressure), cuff pressure
will be essentially constant. It is essential that the cuff size is correct: undersized cuffs may yield too
high a pressure; oversized cuffs yield too low a pressure. When blood flow is present, but restricted,
the cuff pressure, which is monitored by the pressure sensor, will vary periodically in synchrony
with the cyclic expansion and contraction of the brachial artery, i.e., it will oscillate. The values of
systolic and diastolic pressure are computed, not actually measured from the raw data, using an
algorithm; the computed results are displayed.
Oscillometric monitors may produce inaccurate readings in patients with heart and circulation
problems, which include arterial sclerosis,arrhythmia, preeclampsia, pulsus alternans, and pulsus
paradoxus.
In practice the different methods do not give identical results; an algorithm and experimentally
obtained coefficients are used to adjust the oscillometric results to give readings which match the
auscultatory results as well as possible. Some equipment uses computer-aided analysis of the
instantaneous arterial pressure waveform to determine the systolic, mean, and diastolic points. Since
many oscillometric devices have not been validated, caution must be given as most are not suitable
in clinical and acute care settings.
The term NIBP, for non-invasive blood pressure, is often used to describe oscillometric monitoring
equipment.

ECG Module
The electrical current generated by the heart is conducted through the pairs of electrodes and leads,
and is amplified, recorded, and processed by the electrocardiograph. The wires connecting the pairs
of electrodes on the surface of the body to the electrocardiograph are called leads. The different
features and modules of a typical electrocardiograph include the protection circuitry, lead selector,
calibration signal, preamplifier, isolation circuit, driver amplifier, memory system, microcomputer,
and recorder or printer (Neuman, 1992).
The protection circuit prevents any damage due to high voltages that may appear as inputs to the
electrocardiograph. This is useful in situations such as when a patient is being defibrillated. The lead
selector can be controlled by an operator or automated, and provides the ability to record from
various combinations of the leads connected to the patient. The electrocardiograph is usually
calibrated before an acquisition session by a 1-mV calibration signal which is applied to each
channel recorded. The output for the calibration signal should be the same for each channel
recorded.
The preamplifier stage consists of a differential amplifier with a high CMRR
The high CMRR ensures that any potential on the patient's body that is common to both inputs of
the differential amplifier is not amplified by the electrocardiograph. The preamplifier stage feeds an
isolation circuit, which acts as a barrier by preventing more than 10 A of 60-Hz current flowing
through the patient to ground even under the fault condition of the patient accidentally coming in
contact with 120 V from the power line.
The input of the driver amplifier circuitry is ac-coupled and this prevents the output of further
amplifier stages from saturating due to the offset in the input signal. The ECG is then filtered with
an upper corner frequency (3 dB) of 150 Hz and amplified sufficiently so that it can be recorded.
Modern electrocardiographs include an analog-to-digital converter (ADC) to digitize the signal.
Data segments of the ECG from each lead, and other relevant information of the patient can be
stored in memory. A microcomputer in the electrocardiograph also enables the operator to select
leads to record, process ECG signals, perform preliminary arrhythmia analysis and other related
tasks.

SpO2 Module
Oxygen saturation is defined as the ratio of oxyhemoglobin to the total concentration of hemoglobin
present in the blood (ie Oxyhemoglobin + reduced hemoglobin).

Hemoglobin is a iron-containing protein bound to red blood cells and makes up nearly all the
oxygen presence (there is a minute amount dissolved in the plasma). Hemoglobin is responsible for
transporting oxygen from lungs to other parts of the body, where the oxygen can be used by other
cells. Oxyhemoglobin (HbO2) is the bright red hemoglobin that is a combination of hemoglobin and
oxygen from the lungs.
A hemoglobin molecule can carry a maximum of four oxygen molecules. 1000 haemoglobin
molecules can carry a maximum of 4000 oxygen molecules; if they together were carrying 3600
oxygen molecules, then the oxygen saturation level would be (3600/4000)*100 or 90%.

When arterial oxyhemoglobin saturation is measured by an arterial blood gas it is called SaO2.
When arterial oxyhemoglobin saturation is measured non-invasively by pulse oximetry, it is called
SpO2.

Methods for measuring oxygen saturation

A device intended for the non-invasive measurement of arterial blood oxygen saturation and pulse
rate. Typically it uses two LEDs (light-emitting diodes) generating red and infrared lights through a
translucent part of the body. Bone, tissue, pigmentation, and venous vessels normally absorb a
constant amount of light over time. Oxyhemoglobin and its deoxygenated form have significantly
different absorption pattern. The arteriolar bed normally pulsates and absorbs variable amounts of
light during systole and diastole, as blood volume increases and decreases. The ratio of light
absorbed at systole and diastole is translated into an oxygen saturation measurement.

What are permissible levels of SpO2?

Usually, levels of SpO2 range from 96 to 99% in healthy individuals.
However, when patients have pulmonary or cardiovascular chronic diseases at the same
time as a common cold or pneumonia, the level of SpO2 may drop rapidly. SpO2 lower than
90% is defined as acute respiratory failure. When SpO2 drops by 3 to 4% from its usual level,
even if it is not less than 90%, an acute disease may be suspected.
In some patients, usual levels of SpO2 may be below 90%. Most other individuals will have
fluctuations of 3 to 4%.
Depending on individual pulmonary or cardiovascular conditions, the level of SpO2 may be
relatively higher at rest, even though the level drops considerably during exercise or sleep.
As with “normal” body temperature, the level of SpO2 varies from person to person. Since
pulse oximeters may produce errors, there is no “correct” or “incorrect” result.
Therefore, it is best to record the individual‟s level of SpO2 over a long period, and determine
their typical range at rest and at various levels of activity so that abnormal decreases can be
detected.

IBP Modular
Introduction
Invasive (intra-arterial) blood pressure (IBP) monitoring is a commonly used technique in the
Intensive Care Unit (ICU) and is also often used in the operating theatre. The technique involves the
insertion of a catheter into a suitable artery and then displaying the measured pressure wave on a
monitor. The most common reason for using intra-arterial blood pressure monitoring is to gain a
„beat-to-beat‟ record of a patient‟s blood pressure.
Advantages of IBP monitoring
• Continuous „beat-to-beat‟ blood pressure monitoring is useful in patients who are likely to display
sudden changes in blood pressure (e.g. vascular surgery), in whom close control of blood pressure is
required (e.g. head injured patients), or in patients receiving drugs to maintain the blood pressure
(e.g. patients receiving inotropes such as epinephrine).
• The technique allows accurate blood pressure readings at low pressures, for example in shocked
patients.
• The trauma of repeated cuff inflations is avoided in patients who are likely to need close blood
pressure monitoring for a long period of time e.g. ICU patients.
• Intravascular volume status can be estimated from the shape of the arterial pressure trace, either by
eye or by waveform analysis by a specific device e.g. a pulse contour analysis system.
• IBP measurement allows accurate assessment of blood pressure in certain patients not suitable for
non-invasive blood pressure monitoring, e.g. patients with gross peripheral oedema in ICU or
morbidly obese patients.
• The indwelling arterial cannula is convenient for repeated arterial blood sampling, for instance for
arterial blood gases. This is not usually the sole reason for insertion of an indwelling arterial
catheter.

Disadvantages of IBP monitoring

• The arterial cannula is a potential focus of infection, although arterial lines become infected far
less frequently than venous lines, especially central venous lines.• The arterial catheter can lead to
local thrombosis which may result in emboli travelling down the limb or occasionally arterial
occlusion – this is rare if the
Invasive blood pressure monitoring
• Any drug inadvertently administered into the arterial line may form crystals and cause catastrophic
ischaemia of the limb. Examples of drugs with which this has been reported are thiopentone and
antibiotics. All arterial lines should be clearly labelled and the tubing colour coded (usually with a
red stripe) to avoid confusion and drugs should never be administered via the arterial line.
• The insertion of an intra-arterial blood pressure monitoring system can be difficult and time
consuming, especially in shocked patients. This can potentially distract from other problems that
need more urgent attention.
• The monitoring equipment, spare parts and cannulae are expensive when compared to non
invasive methods of blood pressure monitoring.
• The arterial monitor requires an electrical supply which will limit its usefulness in some settings.

EtCO2 Modular (sidestream )

ETCO2 is the partial pressure or maximal concentration of carbon dioxide (CO2) at the end of an
exhaled breath, which is expressed as a percentage of CO2 or mmHg. The normal values are 5% to
6% CO2, which is equivalent to 35-45 mmHg. CO2 reflects cardiac output (CO) and pulmonary
blood flow as the gas is transported by the venous system to the right side of the heart and then
pumped to the lungs by the right ventricles. When CO2 diffuses out of the lungs into the exhaled air,
a device called capnometer measures the partial pressure or maximal concentration of CO2 at the
end of exhalation. During CPR, the amount of CO2 excreted by the lungs is proportional to the
amount of pulmonary blood flow.
ETCO2 Monitoring Technologies
One way of measuring ETCO2 is with the infrared capnometer, which contains a source of infrared
radiation, a chamber containing the gas sample, and a photodetector. When the expired CO2 passes
between the beam of infrared light and photodetector, the absorbence is proportional to the
concentration of CO2 in the gas sample. The gas samples can be analyzed by the mainstream
(in-line) or sidestream (diverting) techniques.

ICG Module
Impedance Cardiography (ICG) is a noninvasive way of assessing the ability of the heart to pump
blood through the arterial system and to estimate thoracic fluid content.1 ICG provides a continuous,
painless, and virtually risk-free method to obtain hemodynamic data that have been shown to have
diagnostic, therapeutic, and prognostic benefits.2-4 The purpose of this paper is to provide an
overview of the technique of ICG and the parameters this technology provides.
ICG Technology
As shown in Figure 1 below, dual sensors are placed on each side of a patient‟s neck and chest. The
ICG device transmits an electrical signal and measures the impedance (or resistance) to the flow of
the electrical signal through the patient‟s chest. (This signal is not perceptible to the patient and does
not interfere with most other medical devices.) Most of the electrical signal travels along the aorta,
because blood in the aorta is more conductive than air in a patient‟s lungs. With every heartbeat, the
volume and velocity of blood in the aorta changes, which changes the measured impedance and
produces characteristic ICG waveforms, as shown in Figure 2. CardioDynamics‟ ICG devices utilize
a sophisticated and proprietary algorithm, Z MARCTM (Impedance Modulating AoRtic
Compliance), to process ECG, ICG, and dZ/dt waveforms to measure or calculate key parameters.
ICG Parameters

The parameters that are measured and calculated by ICG are shown in Figure 3 below. Although
arterial pressure is listed as a measured parameter, it is measured by an optional blood pressure
module and is not obtained via ICG. However, when blood pressure data are available, it is possible
to calculate systemic vascular resistance / index and work of the left ventricle on a per beat basis
(left stroke work) and a per minute basis (left cardiac work), which are listed with the calculated
parameters. Similarly, when pulse oximetry and hemoglobin data are available, it is possible to
calculate delivered oxygen (DO2).
Figure 4 places the parameters into major categories of Flow, Resistance, Contractility, and Fluid.
Flow refers to the flow of blood into the aorta on a per beat basis (stroke volume) and a per minute
basis (cardiac output). Resistance refers to the resistance blood encounters as it flows through the
arterial system. Contractility refers to parameters that provide indices of the speed and strength of
contraction of the left ventricle. Fluid refers to an estimate of the amount of fluid in the patient‟s
chest, which is based upon the measured thoracic impedance.

Contractility
It is often helpful to consider the absolute value of the parameters such as stroke volume, cardiac
output, systemic vascular resistance, left stroke work, and left cardiac work. However, there are
times it is desirable to consider these parameters indexed to the patient‟s body size and this is done
by dividing the absolute value by the patient‟s body surface area. For example, a cardiac output
value of 4.5 liters / minute would typically be in the normal range. However, if the patient is tall and
overweight (e.g., 6‟4”(193 cm) and 250 lbs (114 kg)), the person‟s body surface area would be 2.44
and the cardiac index would be 1.8 l/min/m2 (CO of 4.5 / BSA of 2.44 = CI of 1.8), which is
abnormally low. So, both the absolute and relative values of many parameters are reported by
CardioDynamics‟ ICG products.

C.O. Module
Cardiac Output is the volume of blood that the heart is able to pump out per
unit time, represented in Liters per minute.
The cardiac output represents the volume of blood that is delivered to the body, and is therefore an
important factor in the determination of the effectiveness of the heart to deliver blood to the rest of
the body, (i.e., determining heart failure, inadequate circulation, etc).
By definition, two major factors contribute to the cardiac output: the heart rate, which is the
number of heart loads of blood is ejected per unit of time, and the stroke volume, which is
effectively the volume of blood that the heart can fill with, which will be ejected upon contraction.
Increasing the heart rate effectively increases the cardiac output by increasing the number of cardiac
volumes of blood released into the system. As long as the heart is given a long enough diastole
(resting phase), the effective volume that the heart outputs will increase.
The stroke volume can be increased by three different factors: the preload, the after load, and the
myocardial contractility. A high venous pressure (preload) can increase the stroke volume by
causing the heart to fill more fully during diastole. The increased blood pressure forces more blood
to flow into the heart, down a steep pressure gradient. Similarly, a decrease in the after load
(arterialblood pressure) can also increase cardiac output, by reducing the input resistance the heart
must overcome in order to pump blood into the vasulature. If the arterial pressure is high, the heart
must work harder, against a steep pressure gradient in order to pump more blood into the system. If
the arterial pressure is lower, the heart need not work as hard, and more of the total heart volume
actually ends up being ejected into the vasculature.
The myocardial contractility affects the pumping efficiency of the heart. A higher contractility
allows the heart to pump out more of its blood during systole, due to the increased ejection force of
the cardiac muscles. By allowing the heart to pump out more of its volume into the vasculature
(high cardiac efficiency), the cardiac output is increased.
Assesment of the cardiac output is important in determining the work that the heart is actually
performing with respect to the rest of the cardiovascular system. If the cardiac output is too low,then
the body is not being properly supplied with blood (heart failure), which can and will lead tolife
threatening problems if left unchecked. Cardiac Output is usually measured using the Fick Principle,
which relates the cardiac output of the patient to the oxygen consumption, or by thermodilution, in
which cold saline is injected into the right atrium and changes in the temperature in the pulmonary
artery are recorded. These methods allow one to determine the amount of blood being delivered to
the vasculature by the heart, and whether its output is sufficient tosustain the health of the patient.
Equations:
Cardiac Output = Heart Rate x Stroke Volume
[Co = HR x SV]
Cardiac Output = Oxygen Consumption/(pulm venous O2 content - pulm arterial O2 content)
[Co = q/(O2_pv - O2_pa)] :: Fick's principle

IOC Module
The IoC records the electroencephalogram (EEG) with 3 surface electrodes attached to the forehead
of the patient. The IoC-amplifier (with Bluetooth transmitter) is placed close to the patient while the
IoC display can be placed anywhere (within a 10 m distance) from the patient. IoC-view is the only
true wireless solution, where recording and display are inherently separated meaning no disturbing
cables between patient and the anaesthesia monitor rack.

The core technology of the IoC-view is the symbolic dynamics method. The combination of spectral
ratios, symbolic dynamics EEG and Suppression Rate (ESR) for analyzing the EEG gives a superior
suppression of facial EMG which otherwise could influence the index.
 Chapter 3 Testing and Maintenance

3.1 Introduction

To ensure the patient monitor always functions normally, qualified service personnel should perform
regular inspection, maintenance and test. This chapter provides a checklist of the testing procedures
for the patient monitor with recommended test equipments and frequency.
The service personnel should perform the testing and maintenance procedures as required and
use appropriate test equipment.
The testing procedures provided in this chapter are intended to verify that the patient monitor meets
the performance specifications. If the patient monitor or a module fails to perform as specified in
any test, repairs or replacement must be done to correct the problem. If the problem persists, please
contact our C.S. Dept.

CAUTION
 All tests should be preformed by qualified service personnel only
 Service personnel should acquaint themselves with the test tools and make sure that test
tools and cable are applicable.

3.1.1 Test Equipment

See below sections

3.1.2 Test Report

Upon completion of the tests, the table of preventative maintenance test reports and the table of
maintenance test reports in this chapter should be kept properly.

3.1.3 Preventative Maintenance

Below are preventative maintenance tests which need to be performed on the monitor. See the
following sections for detailed maintenance procedures.
 Visual inspection
 NIBP test and calibration
 EtCO2 test and calibration
 AG test and calibration

3.2 Preventative Maintenance Procedures

3.2.1 Visual Inspection

Inspect the equipment for obvious signs of damage. The test is passed if the equipment has no
obvious signs of damage. Follow these guidelines when inspecting the equipment:
 Carefully inspect the case, display screen, buttons and knob for obvious signs of damage.
 Inspect the power cord, wall-mount bracket and module accessories for obvious signs of
damage.
  Inspect all external connections for loose connectors, bent pins or frayed cables
 Make sure that safety labels and data plates on the equipment are clearly legible

3.3 Power On Test

This test is to verify that the patient monitor can power on correctly. The test is passed if the patient
monitor starts up by following this procedure:
1. Insert a battery in the battery chamber and connect the patient monitor to the AC mains, the AC
mains LED.
2. Press the power on/ off button to switch on the patient monitor. The operating status LED lights
up, and the charge icon will show on top right of LCD screen.
3. After switch on patient monitor, enter the DEMO mode, check the alarm LED and Speaker.

3.4 Module Performance Tests

3.4.1 ECG Test

ECG Performance Test

Tool required:
 Fulke Medsim 300B 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=80bpm with the amplitude as 1mV.
3. Check the ECG waves are displayed correctly without noise and the displayed HR value is
within ±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 (Paced) to(Yes) on the monitor Check the
pace pulse marks on the monitor screen.
ECG Calibration
Tool required:
 Vernier caliper
Follow this procedure to perform a calibration:
1. Select (Main Menu)(survey) (ECG CAL)
2. Select (ECG CAL), A square wave appears on the screen and the message( STOP ECG CAL) is
displayed.
3. Compare the amplitude of the square wave with the wave scale. The difference should be within
5%
4. 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.

3.4.2 RESP Performance Test

 Tool Required:
 Fluke Medsim 300B 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 II as the
respiration lead.
2. Configure the simulator as follows: lead II as the respiration lead, base impedance line as
1500Ω; delta impedance as 0.5Ω, respiration rate as 40 rpm.
3. Check the Resp wave is displayed without any distortion and the displayed Resp value is within
40±2rpm.

3.4.3 SpO2 Test

Tool Required:
 None
Follow this procedure to perform the test:
1. Connect SpO2 sensor to the SpO2 connector of the monitor, 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 displayed 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.
NOTE
 A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor.
However, it can be used to demonstrate that a particular pulse oximeter monitor reproduces a
calibration curve that has been independently demonstrated to fulfill a particular accuracy
specification

3.4.4 Temp Test

Tool required:
 Resistance sensor (1354.9Ω=37℃)
Follow this procedure to perform the test:
1. Insert the Temp probe(Resistance sensor) into any Temp connector of monitor.
2. Verify each Temp channel of the monitor and make sure that the displayed value is within
37℃±0.1℃
You can also use a patient simulator to perform the Temp test.

3.4.5 IBP Tests

IBP Performance Test

Tool required:
 Medsim 300B patient simulator, MPS450, or other equivalent device
 Dedicated IBP adapter cable
Follow this procedure to perform the test:
1. Connect the patient simulator with the pressure module
2. Make the patient simulator outputs 0 to each IBP channel.
3. Press the Zero Key on the module to make a zero calibration.
4. Configure the patient simulator as P(static)= 200 mmHg
5. The displayed value should be within 200±2mmHg.
6. If the value is outside of these tolerances, calibrate the pressure module. If the IBP module was
calibrated with a dedicated reusable IBP sensor, check the calibration together with this IBP
sensor.
7. Make that the patient simulator outputs 120/80 mmHg ATR signals and 120/0 mmHg LV
signals respectively to each IBP channel and check that the IBP wave is displayed correctly.
8. Repeat the steps above for all the IBP channels
IBP Pressure Calibration
Method 1:
Tools required:
1. Medsim 300B patient simulator, MPS450, or other equivalent device
2. Dedicated IBP adapter cable
Follow this procedure to perform the test:
1. Connect the patient simulator to the pressure connector on the module.
2. Set the patient simulator to 0 pressure for the desired IBP channel.
3. Press the Zero Key on the module to make a zero calibration.
4. Configure the patient simulator as P(static)= 200mmHg.
5. Select (Survey Setup)(IBP Setup)(CAL), set the calibration value to 200mmHg.
6. Select the (CAL) button to the desired IBP channel to start a calibration.
7. If the calibration is completed successfully, the message(Calibration Completed)will be
displayed. Otherwise, corresponding message will be displayed.
Method 2
Tools required
1. Standard sphygmomanometer
2. Balloon pum
3. Tubing
4. T-shape Connector
To perform a calibration as below shown:
1. Connect the 3-way stopcock, the sphygmomanometer and the balloon pump through a T-shape
connector, as shown below.
2. Zero the transducer. Then open stopcock to the sphygmomanometer.
3. Select (Survey Setup )(IBP Setup)(CAL)configure IBP calibration value.
 4. Inflate using the balloon pump until the reading of sphygmomanometer approximates the
preset calibration value.
Adjust the calibration value in the (CAL) menu until it is equal to the reading of
sphygmomanometer.
5. Select the (CH1/CH2 Adjust) button to start a calibration
6. The message (Calibration Completed!) is displayed after a successful calibration. If the
calibration failed, the prompt(Calibration Failed!) will be displayed

3.4.6 C.O. Test

Tools required:
 Medsim 300B patient simulator
 C.O. adapter box
Follow this procedure to perform the test:
1. Connect the patient simulator to the C.O. module using a C.O. main cable.
2. Set the blood temperature(BT) to 37℃ on the patient simulator and check the temperature value
is 37±0.1℃
3. Set(Auto IT) to off and adjust(IT) to 24℃. Select(C.O. Measure) to enter the C.O. measurement
window and set (Comp.Const.)to 0.595.
4. Set the inject temperature to 24℃ and the C.O. to 5L/min on the C.O. simulator. Select(Start)in
the C.O. measurement window to start C.O. measurements and after 3-10 seconds press the run
key on the simulator.
5. Check the C.O. value is 5±0.25L/min.

3.4.7 EtCO2 Test

Tools required:
1. A steel gas cylinder with 6±0.05%CO2
2. A steel gas cylinder with compressed air or N2(with standard concentration)
3. Two 3-way valves(power supply controlled)
4. Flowmeter
 5. Power supply
6. Tube
Follow this procedure to perform the test:
1. Wait until CO2 warmup is finished and then select (Zero Cal.) form (EtCO2 Setup)menu to start
a zero calibration. If the Zero Calibration fails, the prompt message(CO2 Zero Failed) is
displayed. Otherwise. The baseline of waveform recovers to zero.
2. Set (APNEA TIEM) to 10s in the (CO2 Setup) menu.
3. Blow to the CO2 sensor to generate CO2 waveform and then place the sensor in the air. Check if
the alarm message （Apnea）is displayed on the screen.
4. Connect the test system as follows

Indication of numbers in the figure above

1. A steel gas cylinder with 6±0.05% CO2.
2. Flowmeter
3. 3-way valve(power supply controlled)
4. Open to air
5. Power supply
6. Compressed air or N2 with standard concentration
7. Mainstream CO2 sensor
8. Patient monitor
9. Tube
10. Adjust the power supply and turn on/off 3-way valves to ensure that only one cylinder is
connected to EtCO2 sensor via 3-way valves at one time and the flowmeter reading is stable and
within 2-5L/min.
11. Switch between the two cylinders to connect EtCO2 sensor at intervals of 6-10s and check if the
displayed CO2 value is within 6±0.05%.

3.4.8 AG Test

Leakage Test
Follow this procedure to perform the test:
1. Plug the AG module into the module rack.
 2. Wait unit the AG module warmup 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 30s.
Accuracy Test
Tolls required:
1. 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 requirement:
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)
2. T-shape connector
3. 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:

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.
5. Check that the concentration of each composition meets the specification stated in the
operator‟s manual.

3.4.9 ICG Test

Tool required
ICG simulator (BZ-4575)
1. Connect the ICG simulator and the patient monitor using standard ICG cable and sensor.
2. Select(ICG setup)(patient Demographics) and then input parameter values as follows:
Height 180cm CVP 6mmHg
Weight 75Kg PAmean 8mmHg
PAWP 10mmHg
3. Switch on the simulator and set as follows: HR=60±1bpm, VI=61±4/1000s, TFC=32±KOhms.
Then, start ICG monitoring.
4. After the measurement becomes stable and check that the measured results are as follows:
HR=60±1bpm, VI=61±4/1000s, TFC=32±KOhms.
 5. Set on the simulator as follows: HR=70±1bpm, VI=48±4/1000s, TFC=32±KOhms. And then
start ICG monitoring. After the measurement becomes stable and check that the measured
results are as follows: HR=70±1bpm, VI=48±4/1000s, TFC=32±KOhms.

3.4.10 IOC Test

Tool required:
None
1. Connect the IOC device as below figure shown

2. Switch on IOC device , On the screen the results of the electrodes test is presented. Each
electrode under test is indicated by blinking the frame colour of the corresponding electrode box,
for a fixed interval of time.
For red and green electrodes, the test is passed when the contact impedances of the
electrodes-skin interfaces are less than 15 kOhm. For the yellow electrode test no specific
impedance value is shown, due to a different method of measuring, rather an indication of
passed or failure is shown. The four different symbols appear in the following figure . If
any of 3 electrodes did not pass the test, the test is automatically repeated for all 3
electrodes. When the tests are passed for all 3 electrodes, then the EEG screen is displayed.
3.5 Touch-screen Calibration

Tools required:
None.

1. Select the (main menu)(maintain)password”5188”(Screen adjust)

2. The ※symbol will appear at different positions of the screen.
3. Click in turn the central point of the ※ symbol.
4. After the calibration is completed, system will back to main screen automatically.

3.6 Recorder Check

Tools required:
* None
1. Print ECG or SPO2 waveforms, the recorder should print correctly and the printout should
be clear.
2. Set the recorder to some problem such as out of paper, etc. the patient monitor should give
corresponding prompt messages. After the problem is removed, the recorder should be
able to work correctly.
3. Switch automatic alarm recording for each parameter ON and then set each parameter‟s
limit outside set alarm limits. Corresponding alarm recordings should be triggered when
parameter alarms occur.

3.7 Network Test

Tools required:
 Hub and network cable
 CMS software
 PC

1. Connect the patient monitors to PC via Hub.

2. Set PC IP address (200.200.200.100) subnet mask: (255.255.255.0).
3. Set the IP address for each patient monitor ensure not repeated.
4. Open the CMS software to check whether displayed correctly.

3.8 Battery check

Tools required:
 Multi-meter
1. Check the battery by multi-meter first, the normal voltage of battery is 1.48V.
2. Insert the battery into the chamber of battery, power on patient monitor to verify the
battery is working properly(no AC source)
3. Connect AC power cord, verify battery charge function, the normal charging time about 6
hours and the working time about 2hours.
3.9 Software version

1. Select (info) in (main menu), then you can see “software version” and “compile time “
Chapter 4 Testing and Maintenance

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 dominate the troubles

The troubles we list here are frequently arisen difficulties and the actions we
recommend can correct most problems, but not all of them. For more information
on troubleshooting, contact our Customer Service Department.

4.2 Part Replacement

Modules ,major parts and components in the patient monitor are replaceable. Once
you isolate a module you suspect defective, follow the instructions in repair and
disassemble to replace the module 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 module with the original suspicious module
and continue troubleshooting as directed in this chapter. Defective module can be
sent to us for repair.

To obtain information on replacement parts or order them, please contact with C.S.
Dept.

4.3 Troubleshooting Guide

4.3.1 Power On/Off Failures

Symptoms Possible Cause Corrective Action

The patient monitor AC mains not connected or battery Check that AC mains is
fails to power on. AC voltage is too low properly connected or battery
and battery indicators capacity is sufficient
does not light Cables defective or poorly 1. Check the cables from
connected power switch button to
key board, key board to
power supply board,
power supply board to
main board are correctly
connected.
2. Check that cables and
connectors are not
damaged.
Power switch button defective Replace it
 Power supply board defective Replace it
Main board defective Replace it

4.3.2 Display Failures

Symptoms Possible Cause Corrective Action

The patient monitor fails to Cables defective or poorly 1. Check the cables from
display but the patient connected inverter board to LCD
monitor still works screen, inverter board to
correctly(display is black) power supply board are
correctly connected
Inverter board defective Replace it
Power supply board defective Replace it
Display defective Replace it
The display is blank but the Cables defective or poorly 1. Check the cable from
patient monitor still works connected display to main board is
correctly correctly connected.
Display defective Replace it
Images overlapped or Cables defective or poorly Check the cable from display
distorted connected to main board is correctly
connected.
Display defective Replace it
Touchscreen does not Touchscreen disabled Check it there was locked,
response press the (SCR UNLOCK)
button to unlock it
Cable defective 1. Check the cable from
touch screen to extension
cable and extension cable
are correctly connected.
Touchscreen defective Replace it
Main board defective Replace it
Touch screen position invalid Touch screen not calibrated Calibrate the touch
screen
Main board defective Replace it

4.3.3 Power supply Failures

symptoms Possible Cause Corrective Action

Different battery voltage Battery failure Replace it

Cable defective or poorly Check the cable from battery

connected to power supply board
Power supply board defective Replace it
 Battery capacity is too Battery failure Replace it
low/voltage is too low
Battery cannot be recharged Battery failure Replace battery and recharge
the replacement battery, if the
replacement battery can be
recharged , the original one
fails
Cable defective or poorly Check that cable from battery
connected to power supply board
Power board failure Replace it
NO +3.3V output Power supply failure Replace it

NO +5 V output

NO +12 V output

4.3.4 Button and Knob Failures

Symptoms Possible Cause Corrective Action

Buttons do not work Cable defective or poorly 1. Check the cable between
connected button and main board is
properly connected
2. Check the connecting
cables and connectors are
not damaged
Button board failure Replace button board
Main board defective Replace main board
Knob does not work Cable defective or poorly Check the cable between
connected button board and knob board
is properly connected
Knob defective Replace Knob

4.3.5 Recorder Failures

Symptoms Possible Cause Corrective Action

No printout Paper reversed Re-install the paper.

Cable defective or poorly 1. Check that cable between
connected recorder and mother
board is properly
connected.
2. Check the connecting
cables and connectors are
 not damaged
Recorder power supply Check if the power supply
failure outputs 5V and 12V DC
correctly.
Recorder failure Replace it
Poor print quality or paper Print head dirty 1. Check the thermal print
not feeding properly head ensure not foreign
matter.
2. Clean the thermal print
head with an appropriate
clean solution.
Recorder failure Replace it

4.3.6 ECG Failures

Symptoms Possible Cause Corrective Action

No ECG waveform and value ECG patient Cable defective 1. Check the ECG patient
Cable , replace this cable
by a known good one.

Cables defective or poorly 1. Check the cable from

connected ECG module to main
board is properly
connected.
2. Check the connecting
cable and connector are
not damaged
ECG module defective Replace it
Main board defective Replace it
No ECG baseline Cables defective or poorly 1. Check the cable from
connected ECG module to main
board is properly
connected.
2. Check the connecting
cable and connector are
not damaged
ECG module defective Replace it
Main board defective Replace it
ECG waveform drift or Cables defective or poorly 1. Check the cable from
unstable connected ECG module to main
board is properly
connected.
2. Check the connecting
cable and connector
are not damaged
3. Electrodes are placed
in right position
 ECG module defective Replace it
ECG value inaccuracy ECG patient defective or Check the ECG patient
poorly connected Cable , replace this cable
by a known good one.

ECG module defective Replace it

4.3.7 Comen SpO2 Failures

Symptoms Possible Cause Corrective Action

No SpO2 waveform and SpO2 sensor defective or Check the SpO2 sensor
value poorly connected with a known good one

Cables defective or poorly Check the cable from

connected main board to SpO2
board and SpO2 board to
interface panel are
correctly connected.
SpO2 module defective Replace it
Main board defective Replace it
SpO2 value inaccuracy SpO2 sensor defective or Check the SpO2 sensor
poorly connected with a known good one

SpO2 module defective Replace it

4.3.8 NIBP Failures

Symptoms Possible Cause Corrective Action

No NIBP value NIBP cuff or tube replace the Cuff and tube
damaged(air leakage) or with known good one in
poorly connected turn
Cables /air hose and Check the cable from NIBP
connector are damaged board to main board and main
board to the side panel
Movement during measuring The Arm which strapped cuff
and heart should be at same
elevation
NIBP board defective Replace it
Main board defective Replace it
NIBP value incorrectly Movement during measuring The Arm which strapped cuff
and heart should be at same
elevation
NIBP cuff or tube Replace the Cuff and tube
 defective(air leakage) with known good one in turn
NIBP board defective Replace it

4.3.9 Respiration Failures

Symptoms Possible Cause Corrective Action

NO RESP waveform and Patient cable damaged or 1. Replace patient cable

value poorly connected with a known good one
2. Ensure electrodes are
good conductively
3. Patient cable leads placed
on right position
ECG module defective Replace it

4.3.10 EtCO2 Failures

Symptoms Possible Cause Corrective Action

NO EtCO2 waveform and Sampling tube /airway replace the sampling tube or
value adapter defective or poorly airway adapter with new one
connected
Cable defective or poorly Check the cable from main
connected board to side panel is
correctly connected
EtCO2 module defected 1. Check the EtCO2 motor
is working or not
2. The indicator is lighting
when sampling tube was
connected
3. Replace it with a known
good one
Main board defective Replace it
EtCO2 value inaccuracy Calibration calibrating before use
Sampling tube /airway replace the sampling tube or
adapter defective or poorly airway adapter with new one
connected
EtCO2 module defective Replace it

4.3.11 Software Upgrade Failures

Symptoms Possible Cause Corrective Action

U-disk can not be detected U-disk problem 1. Ensure the brand is

Kingston ,capacity less
than 2GB
 2. Format : FAT
Version: 2.0
USB port defective or poorly Check the cable from main
connected board to usb port is correctly
connected
Main board defective Replace it
“updating is failed” Name of file incorrect Correct the name of file
Software damaged or Change the software, then try
incorrect again
Stop in “System is updating” Usb disk format incorrect Change the usb disk format to
“FAT”
Main board defective Replace it
 Chapter 5 Disassembling Procedure
The following section describes the disassembly and reassembly procedures for the monitor and its
components

5.1 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 r death.
Tools required
 Torx screwdrivers
 Small flat head screwdriver
 Needle Nose Pliers
 ESD mat and wrist strap
 Cleaning Agent
 Tweezer

5.2 Removing the modular boxes and C30

1. Press the lock button to drawing out C30 from modular slot.(installation: push the C30 into the
Modular Rack until it was locked up)
 2. Press the lock button(on bottom of modular) to drawing out all of the modulars for Modular
Slot.(installation: push the modular into the modular Slot until it was locked up)

5.3 Separating the Front and Rear Housing

1. Removing two covers ,then unscrew two screws as figure shown;

2. Removing two screws from right side covered by multi interface cover, press the cover to open it, unscrew
two screws as below shown;

4. Unscrew last two screws()as below shown;

5. Unplug the cables that connect to the front panel to separate the front panel from the rear housing:
 5.4 Removing the Recorder

1. Press the lock of recorder to open the cover, unscrew two screws as below shown;

2. Pulling out the recorder and unplug the connect wire as below shown;

5.5 Removing the Button Board

1. Separating Front and Rear housing as above shown;

2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Remove 6 screws from PCB board to take the button board out;
 5.6 Removing the Inverter board and Touch-screen
Control board

1. Separating front and rear housing as (section 5.2) shown

2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Unscrew 4 screws to remove shield cover and 4 screws from inverter board to take it out as below
shown;
5. Unscrew 2 screws from converter PCB board and disconnect the wires to take it out.

PWM 3.0×6mm

PWM 3.0×6mm

Caution: High voltage on the inverter board when power on

5.7 Removing the Touchscreen & LCD panel

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 disassemble
1. Separating front and rear housing as (section 5.2) shown
2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Disconnect the wires(alarm wire, LCD cable, inverter wire, touch-screen wire );
5. Unscrew 9 screws to take out the LCD frame;

6. Put the LCD screen surface upward, then remove 4 screws to take it out; (don‟t touch display surface by
hand and prevent it from being contaminated by dust)

PWM 3.0×6mm
 7. After take out the display, then we can take the touch screen out. (don‟t touch display surface by hand
and prevent it from being contaminated by dust)

Note: place the touch screen onto front shell carefully, ensure it’s in right place before install display

5.8 Removing the Alarm LED Board:

1. Separating front and rear housing as (section 5.2) shown;

2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Disconnect alarm wire and unscrew two screws(PWM 3.0×6mm) to take alram lamp(LED) board out;

Alarm board
 5.9 Removing the Main Board

1. Separating front and rear housing as (section 5.2) shown;

2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Disconnect the cables which connected to main board, then unscrew 6 screws to remove it as below figure
shown;

5.10 Removing the DC Power Supply Board

1. Separating front and rear housing as (section 5.2) shown;

2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Disconnect all the cables which connected to DC power supply board, then unscrew 6 screws to remove
it as below figure shown;
 5.11 Removing Modular Slot

1. Separating front and rear housing as (section 5.2) shown;

2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Disconnect all the cables which connected to transmit board, then unscrew 5 screws from Modular Slot
to take it out , as below figure shown;
 5.12 Removing the Multi-interface Board

1. Separating front and rear housing as (section 5.2) shown;

2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Disconnect all the wires which connected to Multi-interface board, unscrew 4 screws to take it out, as
below figure shown;

5. Remove VGA/Nurse/Defib interface board and USB/Net interface board

 5.13 Removing the Speaker and Fan

1. Separating front and rear housing as (section 5.2) shown;

2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Disconnect Speaker wire and unscrew 4 screws to take it out.
5. Disconnect Fan wire and unscrew 4 screws to take it out.

5.14 Removing the AC Power supply board

1. Separating front and rear housing as (section 5.2) shown;

2. Disconnect all the cables which connect with rear shell parts;
3. Place the front shell down, ensure not to damage the LCD screen and front shell;
4. Remove Main Board as above shown;
5. Remove Multi-interface Board as above shown;
6. Unscrew 4 screws underneath the module frame, to take the AC power supply board compartment out.
 7. Unscrew 4 screws to remove the aluminium plate , then unscrew 4 screws to take out the AC power
supply board;

5.15 Removing the Base Part

1. Unscrew 4 screws to take base part out as below figure shown;

 5.16 Removing the battery

1. Unscrew 2 screws from base part to remove battery as below show

 5.17 Removing the Power ON/OFF button

1. Take out the base part as described above;

5.18 Disassembling Procedure for C30

5.18.1 Exploded diagram of C30;

1 Touch screen panel 16 Right-screw rubber plug

 2 Front shell 17 handle
3 LCD screen 18 Screw rubber plug
4 LCD bracket 19 Handle stator
5 Silicone keypad 20 Rear shell
6 Key board(PCB) 21 Fan
7 Main frame 22 Speaker
8 Value holder 23 DC power supply
9 Air valve 24 Air pump
10 Interface panel 25 Ten-four way
11 side shell 26 T-four way
12 Limit pin 27 Ground pole socket
13 battery 28 Battery connector board
14 hooker
15 Left-screw rubber plug

5.18.2 Separating the front and rear housing;

1. Removing the cover (on right side of device )by a straight screwdriver;

Notch

2. Removing the side cover of parameter interface; press the two clips down by a flat screwdriver
in turn, at same time, push the side cover outwards by thumb.

3. Removing 4 screws on back side, pressing the clip(on the bottom of device) down by a flat
screwdriver , meanwhile, push the front shell outwards to separate it from rear housing;
4. Placing the front shell down and disconnect the flex cables;

5. Removing the module frame (with modules); Removing two plastic pins from parameter
 interface board and drawing the module frame out horizontally.

6. Separating the parameter interface board from module frame , hold the module frame and
pulling parameter interface board out toward the right side softly, then disconnect the air hose
from NIBP pump; (avoid damage the sockets )
7. Unscrew 2 screws to remove the SpO2 board;

8. Removing the main board from module frame by unscrew 4 screws and 2 hex copper post.
9. Unscrew 4 screws to remove ECG board;

10. Unscrew 3 screws and disconnect the wires to take interface board out;
11. Unscrew 2 screws to remove Fan and release the snap to take out the speaker ;

12. Removing the air pump and air valve;

13. Unscrew 2 screws to remove key board;

14. Unscrew 4 screws to remove display panel and touch screen

15. Unscrew 2 screws to take out the battery.
 Chapter 6 Electrical Safety Inspection
The following electrical safety tests are recommended as part of a comprehensive preventive
maintenance program. They are a proven means of detecting abnormalities that, if undetected,
could prove dangerous to either the patient or the operator. Additional tests may be required
according to local regulations.
All tests can be performed using commercially available safety analyzer test equipment.
These procedures assume the use of a 601PROXL International Safety Analyzer or equivalent
safety analyzer. Other popular testers complying with IEC 60601-1 used in Europe such as
Fluke, Metron, or Gerb may require modifications to the procedure. Follow the instructions
of the analyzer manufacturer.
The consistent use of a safety analyzer as a routine step in closing a repair or upgrade is
emphasized as a mandatory step if an approved agency status is to be maintained. The safety
analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line
voltage and grounding, as well as total current loads.

6.1 Power Cord Plug

Test Item Acceptance Criteria

The power plug The power plug pins No broken or bent pin. No discolored pins
The plug body No physical damage to the plug body
The strain relief No physical damage to the strain relief. No plug
Warmth for device in use
The power plug No loose connections
The power cord No physical damage to the cord. No deterioration to
the cord
For devices with detachable power cords
For devices with non-detachable power cords,
Inspect the strain relief at the device.

6.2 Device Enclosure and Accessories

�Visual Inspection
Test Item Acceptance Criteria
The enclosure and accessories No physical damage to the enclosure and accessories
No physical damage to meters, switches, connectors, etc
No residue of fluid spillage(e.gl, water, coffee, chemicals,
etc.)
No loose or missing part(e.g., knobs, dials, terminals, etc.)

Contextual Inspection
Test Item Acceptance Criteria
The enclosure and accessories No unusual noise(e.g. , a rattle inside the case)
No unusual smells(e.g., burning or smoky smells,
particularly from ventilation holes)
No taped notes that may suggest device deficiencies or
operator concerns

6.3 Device Labeling

Check the labels provided by the manufacturer or the healthcare facility are present and
legible.
�Main unit label
�Integrated warning labels

1. Protective Earth Resistance

Protective Earth Resistance is measured using the RED test lead attached to the DUT
Protective Earth terminal or enclosure. Select the test current by pressing SOFT KEY 3 to
toggle between 1AMP, 10AMP, and 25AMP. The front panel outlet power is turned off for
this test.
The following conditions apply: L1 and L2 Open.

Preparation
1. First select the test current that will be used for performing the Protective Earth
Resistance test by pressing AMPERES (SOFT KEY 3).
2. Connect the test lead(s) between the RED input jack and the GREEN input jack.
3. Press CAL LEADS. The 601PRO will measure the lead resistance, and if less than 0.150
Ohms, it will store the reading and subtract it from all earth resistance readings taken at
the calibrated current.
If the calibration fails, the previously stored readings will be used until a passing calibration
has occurred.:

WARNING
�During Earth Resistance testing, the DUT must be plugged into the 601PRO
front outlet. If the DUT fails Earth Resistance, discontinue tests and label the
device defective.

To Perform the Test

1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet.
2. Attach the 601PRO RED input lead to the device‟s Protective Earth terminal or an
exposed metal area.
3. Press shortcut key 3. The Protective Earth Resistance test is displayed.
4. Press SOFT KEY 3 to select a test current (1AMP, 10AMP, or 25AMP). The selected
test current is displayed in the upper right corner of the display.
5. Press START TEST to start the test. The test current is applied while resistance and
current readings are taken. This takes approximately 5 seconds.
6. Press the print data key at any time to generate a printout of the latest measurement(s).
NOTE
When "Over" is displayed for Ohms, this signifies that a valid measurement was
not obtained because either an open connection was detected or that the
measurement was not within range. Readings greater than 9.999 Ohms will be
displayed as Over.

In Case of Failure
Once it reaches the limitation, stop using and inform the Customer Service Engineer for
analysis and disposal.
LIMITS
ALL COUNTRIES R = 0.2Ω Maximum
A-5

6.4 Earth Leakage Test

Run an Earth Leakage test on the device being tested before performing any other leakage
tests.
Leakage current is measured the following ways:
�Earth Leakage Current, leakage current measured through DUT outlet Earth
�Earth Leakage Current AP-EARTH (ALL Applied Parts connected to Earth), leakage
current measured through DUT outlet Earth
There is no need to attach a test lead; the 601PRO automatically connects the measuring
device internally.
To Perform the Test
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet, and turn on the device.
2. Attach the device's applied parts to the 601PRO applied part terminals if applicable.
3. Press shortcut key 4.The Earth Leakage test appears on the display, and the test begins
immediately:
�SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse.
�SOFT KEY 2 toggles the DUT outlet from Earth to No Earth.
�SOFT KEY 3 toggles the DUT outlet from L2 to No L2.
�SOFT KEY 4 toggles the AP to Earth to No AP to Earth.
4. Press the print data key at any time to generate a printout of the latest measurement.
A-6
In Case of Failure
�Check any broken of the enclosure. Replace any defective part.
�Inspect wiring for bad crimps, poor connections, or damage.
�Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
�Change another probe to confirm if the fail is caused by console.
�Inspect wiring for bad crimps, poor connections, or damage.
�If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
�If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
LIMITS
USA: 300 μA Normal Condition
1000 μA Single Fault Condition
OTHER COUNTRIES: 500 μA Normal Condition
1000 μA Single Fault Condition

6.5 Patient Leakage Current

Patient leakage currents are measured between a selected applied part and mains earth. All
measurements may have either a true RMS or a DC-only response.
Preparation
Perform a calibration from the Mains on Applied Part menu.
The following outlet conditions apply when performing this test:
�Normal Polarity, Earth Open, Outlet ON Normal Polarity, Outlet ON
�Normal Polarity, L2 Open, Outlet ON Reversed Polarity, Outlet ON
�Reversed Polarity, Earth Open, Outlet ON Reversed Polarity, L2 Open, Outlet ON
A-7

WARNING
If all of the applied parts correspond to the instrument type, the applied parts
will be tied together and one reading will be taken. If any of the applied parts
differ from the instrument type, all applied parts will be tested individually,
based on the type of applied part. This applies to Auto and Step modes only.
To Perform the Test

1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet, and turn on the device.
2. Attach the applied parts to the 601PRO's applied part terminals.
3. Press shortcut key 6. The Patient Leakage test is displayed, and the test begins
immediately.
4. Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part
leakage current.
5. Modify the configuration of the front panel outlet by pressing the appropriate SOFT
KEY on the 601PRO.
6. Press the print data key at any time to generate a printout of the latest measurement.

NOTE
� If the current test standard being used does not include Patient Leakage DC
readings, or the DC option is not enabled, then DC readings will not be available
through the APPLIED PART SOFT KEY selections. Refer to Chapter 8,
Standards and Principles.

In Case of Failure
 Check any broken of the enclosure. Replace any defective part.
 Inspect wiring for bad crimps, poor connections, or damage.
 Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
 Change another probe to confirm if the fail is caused by console.
 Inspect wiring for bad crimps, poor connections, or damage.
 If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
 If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
LIMITS
USA:
For ECG Input and ECG Input and other applied parts
�10μA Normal Condition
�50μA Single Fault Condition
OTHER COUNTRIES:
For ECG Input (Defibrillator proof)
�10μA Normal Condition
�50μA Single Fault Condition
For ECG Input and other applied part
�100μA Normal Condition
�500μA Single Fault Condition

6.6 Mains on Applied Part Leakage

The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage,
through a limiting resistance, to selected applied part terminals. Current measurements are
then taken between the selected applied part and earth. Measurements are taken with the
test voltage (110% of mains) to applied parts in the normal and reverse polarity conditions as
indicated on the display.
The following outlet conditions apply when performing the Mains on Applied Part test.
�Normal Polarity;
�Reversed Polarity
Preparation
To perform a calibration from the Mains on Applied Part test, press CAL (SOFT KEY 2).
1. Disconnect ALL patient leads, test leads, and DUT outlet connections.
2. Press CAL to begin calibration, as shown:
�If the calibration fails, the previously stored readings will be used until a passing
calibration has occurred. Also, the esc/stop key has no effect during calibration.
3. When the calibration is finished, the Mains on Applied Part test will reappear.

WARNING
� A 2-beep-per-second signal indicates high voltage present at the applied part
terminals while a calibration is being performed.
� High voltage is present at applied part terminals while measurements are being
taken.
A-10
To Perform the Test
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601
2. Attach the applied parts to the 601PRO applied part terminals.
3. Attach the red terminal lead to a conductive part on the DUT enclosure.
4. Press shortcut key 7. The Mains on Applied Part test is displayed.
5. Select the desired outlet configuration and applied part to test using the appropriate
SOFT KEYS:
6. Press START TEST (SOFT KEY 1) to begin the test.
7. Press the print data key to generate a printout of the latest measurement.

NOTE
If all of the applied parts correspond to the instrument type, the applied parts
will be tied together and one reading will be taken. If any of the applied parts
differ from the instrument type, all applied parts will be tested individually,
based on the type of applied part. This applies to Auto and Step modes only.
In Case of Failure
 Check any broken of the enclosure. Replace any defective part.
 Inspect wiring for bad crimps, poor connections, or damage.
 Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
 Change another probe to confirm if the fail is caused by console.
 Inspect wiring for bad crimps, poor connections, or damage.
 If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
 If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.

LIMITS
USA
For ECG Input and ECG Input and other applied parts
�50μA
OTHER COUNTRIES：
For ECG Input
�50μA
For ECG Input and other applied parts
�5000μA
A-12

6.7 Patient Auxiliary Current

Patient Auxiliary currents are measured between any selected ECG jack and the remaining
selected ECG jacks. All measurements may have either a true RMS or a DC-only response.
Preparation
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet, and turn on the device.
2. Attach the patient leads to the 601PRO ECG jacks.
3. Define the Lead Types from the View Settings Option (refer to: Lead Type Definitions
in Section 5 of this chapter).
4. Press shortcut key 8. The Patient Auxiliary Current test is displayed, and the test begins
immediately. Display values are continuously updated until another test is selected.
5. Press SOFT KEYS 1-4 to select leakage tests
6. Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part
leakage current:
7. Modify the configuration of the front panel outlet by pressing the appropriate SOFT
KEY on the 601PRO:
8. Press the print data key at any time to generate a printout of the latest measurement.

NOTE
� If the current test standard being used does not include Patient Auxiliary
Current DC readings, or the DC option is not enabled, then DC readings will not
be available through the APPLIED PART SOFT KEY selections.
In Case of Failure
 Check any broken of the enclosure. Replace any defective part.
 Inspect wiring for bad crimps, poor connections, or damage.
 Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
A-13
 Change another probe to confirm if the fail is caused by console.
 Inspect wiring for bad crimps, poor connections, or damage.
 If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
 If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
LIMITS
USA
For ECG Input and ECG Input and other applied part
 10μA Normal Condition
 50μA Single Fault Condition
OTHER COUNTRIES:
For ECG Input
 10μA Normal Condition
 50μA Single Fault Condition
For ECG Input
 100μA Normal Condition
 500μA Single Fault Condition