Comen CM300 User manual

Three-Channel Electrocardiograph
CM300
User Manual
Shenzhen Comen Medical Instrument Co., Ltd.

I
Copyright
Version: A
Date: 2012 /10
Part No: 046-000080-00
Statements
Our company makes no warranty of any kind with regard to this material, including, but not
limited to the implied warranties of merchantability and fitness for a particular purpose. Our
company assumes no responsibility for any errors that may appear in this document, or for
incidental or consequential damage in connection with the furnishing, performance or use of
this material.
No part of this document can be photocopied, reproduced or translated to another language
without prior written consent of our company.
Responsibility of the Manufacturer
Our company only considers 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
personnel authorized by our company, and the electrical installation of the relevant room
complies with safety standards, and the instrument is used in accordance with the instructions
for use.
Note: This device is not intended for home use.
WARNING :This device is not intended for treatment.
Using This Label Guide
WARNING
A WARNING label advises against certain actions or situations that could result in
personal injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure.

II
Note: A NOTE provides useful information about a function or procedure.

III
Contents
Chapter 1 Safety Guidance.............................................................................................................................1
1.1 Safety Information ..........................................................................................................1
1.2 Warnings and Cautions....................................................................................................1
1.2.1 Safety Warnings .................................................................................................... 1
1.2.2 Battery Care Warnings ..........................................................................................3
1.2.3 General Cautions...................................................................................................4
1.2.4 Cleaning & Disinfection Cautions ........................................................................5
Chapter 2 Introduction...................................................................................................................................5
2.1 Function Features ............................................................................................................6
2.2 List of Symbols ...............................................................................................................6
Chapter 3 General Information .....................................................................................................................8
3.1Top Panel.......................................................................................................................... 8
3.1.1 LCD Screen...........................................................................................................9
3.1.2 Control Panel and Keys.......................................................................................10
3.2 Patient Cable Socket and Signal Interface ....................................................................12
3.3 Mains Connection and Switch.......................................................................................13
3.4 Bottom Panel ................................................................................................................. 13
Chapter 4 Operation Preparations..............................................................................................................16
4.1 Power and Earthing .......................................................................................................16
4.2 Loading/Replacing Record Paper..................................................................................17
4.3 Patient Cable Connection..............................................................................................18
4.4 Electrodes Connections.................................................................................................19
4.5 Inspection before Power On..........................................................................................21
Chapter 5 Operation Instructions................................................................................................................22
5.1 Switching On.................................................................................................................22
5.2 Automatic Mode............................................................................................................23
5.3 Manual Mode ................................................................................................................23
5.4 ECG Recall.................................................................................................................... 24
5.5 Using the menu system .................................................................................................24
5.5.1 Entering and exiting the menu ............................................................................24
5.5.2 Moving in the sub-menus....................................................................................25
5.5.3 Parameter modification .......................................................................................25
5.6 Settings................................................................................................................... 25
5.6.1Register Settings................................................................................................... 25
5.6.2General Settings ...................................................................................................27
5.6.3Print Settings ........................................................................................................28
5.6.4 SYSTEM Settings ............................................................................................... 30

IV
5.7ECG Record ................................................................................................................... 33
5.8 Switch Off ..................................................................................................................... 34
Chapter 6 Prompt Information....................................................................................................................35
Chapter 7 Clean, Care and Maintenance....................................................................................................36
7.1 Clean..............................................................................................................................36
7.1.1 Clean the Main Unit and Patient Cable...............................................................36
7.1.2 Clean the Electrodes............................................................................................36
7.1.3 Clean the Print Head ...........................................................................................36
7.2 Disinfection ...................................................................................................................37
7.3 Sterilization ...................................................................................................................37
7.4 Care and Maintenance...................................................................................................37
7.4.1 Recharge and Replacement of Battery ................................................................ 37
7.4.2 Record Paper ....................................................................................................... 38
7.4.3 Maintenance of Main Unit, Patient Cable & Electrodes..................................... 39
Chapter 8 Service Warranty.........................................................................................................................41
Appendix I Accessories and Ordering Information.................................................................................42
Appendix II Technical Specifications........................................................................................................43

1
Chapter 1 Safety Guidance
1.1 Safety Information
The design of the 3-channel electrocardiograph complies with international standard IEC
60601-1 Medical Electrical Equipment: General Requirements for Safety and IEC 60601-2-25
Particular Requirements for the Safety of Electrocardiographs etc. The classification of this
equipment is Class І, type CF, which means a higher degree of protection against electric shock
and the patient connection is fully isolated and defibrillation protected.
This equipment is not explosion-proof. Do not use it in the presence of flammable anesthetics.
This equipment is designed for continuous operation and is ‘ordinary’ (i.e. not drip or
splash-proof).
Classification:
1) Anti-electric-shock type: Class Іwith internal power supply
2) Anti-electric-shock degree: CF
3) Degree of protection against harmful
ingress of water:
Ordinary equipment (Sealed equipment without
liquid proof)
4) Disinfection/sterilization method: Refer to the user manual for details
5) Degree of safety of application in the
presence of flammable gas:
Equipment not suitable for use in the presence
of flammable gas
6) Working Mode: Continuous operation
7) EMC: Group І, Class A
1.2 Warnings and Cautions
In order to use the electrocardiograph safely and effectively, avoiding possible dangers caused
by improper operations, please read through the user manual and be sure to be familiar with all
functions of the equipment and proper operation procedures before use.
Please pay more attention to the following warning and caution information.
1.2.1 Safety Warnings
WARNING :

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♦The electrocardiograph is provided for the use of qualified physicians or personnel
professionally trained. And they should be familiar with the contents of this user
manual before operation.
♦Only qualified service engineers can install this equipment. And only service engineers
authorized by our company can open the shell.
♦Only qualified installation or service engineers can shift the mains shift switch
(100V~115V/220V~240V) according to local mains supply.
♦The results given by the equipment should be examined with respect to the overall
clinical condition of the patient. And it can not substitute for regular checking.
WARNING :
♦EXPLOSION HAZARD-Do not use the electrocardiograph in the presence of
flammable anesthetic mixture with oxygen or other flammable agents.
♦SHOCK HAZARD-The power receptacle must be a hospital grade grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet.
♦If the integrity of external protective conductor in installation or arrangement is in
doubt, the equipment should be operated from the built-in rechargeable battery.
♦Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.
♦This equipment is not designed for internal use and direct cardiac application.
WARNING :
♦Only patient cable and other accessories supplied by our company can be used. Or else,
the performance and electric shock protection can not be guaranteed.
♦Be sure that all electrodes have been connected to the patient correctly before
operation.
♦Be sure that the conductive parts of electrodes and associated connectors, including
neutral electrode, should not contact with earth or any other conducting objects.
♦Electrodes with defibrillator protection should be used while defibrillating.
♦There is no danger for patients with pacemaker.
♦Do not touch the patient, bed, table and the equipment while using defibrillator or
pacemaker simultaneously.

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♦In order to avoid burning, please keep the electrode far away from the radio knife
while using electrosurgical equipment simultaneously.
WARNING :
♦Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards (e.g. IEC 60950 for data processing
equipment and IEC 60601-1 for medical equipment). Furthermore all configurations
shall comply with the valid version of the standard IEC 60601-1-1. Therefore anybody,
who connects additional equipment to the signal input connector or output connector to
configure a medical system, must make sure that it complies with the requirements of
the valid version of the system standard IEC 60601-1-1. If in doubt, consult our
technical service department or your local distributor.
♦The summation of leakage current should never exceed leakage current limits while
several other units are used at the same time.
♦The potential equalization conductor can be connected to that of other equipment when
necessary, to make sure that all these equipment are connected with the potential
equalization bus bar of the electrical installation.
1.2.2 Battery Care Warnings
WARNING :
♦Improper operation may cause the battery to be hot, ignited or exploded, and it may
lead to the declination of battery’s capacity. It is necessary to read the user manual
carefully and pay more attention to warning messages.
♦Only qualified service engineer authorized by our company can open the battery
compartment and replace the battery. And the battery of same model and specification
provided by manufacturer should be used.
♦Danger of explosion -- Do not reverse the anode and cathode when connecting the
battery.
♦Do not heat or splash the battery or throw it into fire or water.
♦When leakage or foul smell found, stop using the battery immediately. If your skin or
cloth comes into contact with the leakage liquid, cleanse it with clean water at once. If
the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with clean
water first and go to see a doctor immediately.

4
♦When the battery’s useful life is over, contact with the manufacturer or local distributor
for disposal or dispose the battery according to local regulations.
1.2.3 General Cautions
CAUTION :
♦Avoid liquid splash and excessive temperature. The temperature must be kept between
5℃and 40℃while working. And it should be kept between -20℃and 55℃during
transportation and storage.
♦Do not use the equipment in dusty environment with bad ventilation or in the presence
of corrosive.
♦Be sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitter or mobile phone etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. are likely to bring electromagnetic
interference.
CAUTION :
♦Before use, the equipment, patient cable and electrodes etc. should be checked.
Replacement should be taken if there is any evident defectiveness or aging symptom
which may impair the safety or performance.
♦The following safety checks should be performed at least every 24 months by a
qualified person who has adequate training, knowledge, and practical experience to
perform these tests.
a)Inspect the equipment and accessories for mechanical and functional damage.
b)Inspect the safety relevant labels for legibility.
c)Inspect the fuse to verify compliance with rated current and breaking
characteristics.
d)Verify the device functions properly as described in the instructions for use.
e)Test the protection earth resistance according IEC 601-1/1988: Limit 0.2 ohm.
f) Test the earth leakage current according IEC 601-1/1988: Limit: NC 500 uA, SFC
1000uA.
g)Test the patient leakage current according IEC 601-1/1988: Limit: 10 uA (CF).
h)Test the patient leakage current under single fault condition with mains voltage on
the applied part according IEC 601-1/1988: Limit: 50uA (CF).

5
The data should be recorded in an equipment log. If the device is not functioning
properly or fails any of the above tests, the device has to be repaired.
♦Ruptured fused must only be replaced with the same type and rating as the original.
♦The equipment and reusable accessories can be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
1.2.4 Cleaning & Disinfection Cautions
CAUTION :
♦Turn off the power before cleaning and disinfection. If mains supply used, the power
cord should be drugged out of the outlet also. And prevent the detergent from seeping
into the equipment.
♦Do not immerse the unit or patient cable into liquid under any circumstances.
♦Do not clean the unit and accessories with abrasive fabric and avoid scratching the
electrodes.
♦Any remainder of detergent should be removed from the unit and patient cable after
cleaning.
♦Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
♦Do not use high temperature, autoclaving or radiation sterilization processes.
Chapter 2 Introduction
The machine is 3-channel electrocardiographs with 12 leads gathered simultaneously, visual
display of operation menu, ECG parameters as well as electrocardiogram。
3-channel ECG can be previewed on the LCD (liquid crystal display) screen of the machine
simultaneously. And it can be recorded by high-quality thermal printer.
Manual recording mode and automatic recording mode can be chosen conveniently.
Either mains supply or built-in rechargeable Lithium battery can be used as power.
With a high resolution thermal printer, 32-bit processor and huge capacity memorizer, the
machine has advanced performance and high reliability. And the compact size makes it suitable
for clinic, hospital and ambulance use.
Configurations: Main unit and accessories (power cord, earth wire, patient cable, electrodes
and thermal print paper)

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2.1 Function Features
♦Low weight and compact size
♦Touch key for easy operation
♦High resolution thermal printer, recoding frequency response ≤150Hz
♦12-lead gathered and amplified simultaneously, 3-channel built-in printer.
♦Automatic mode and manual mode optional
♦LOGIN/PRINT/GENERAL/SYSTEM menu for parameters setting
♦Built-in rechargeable Li battery with high capacity
♦Prompt information for lead off, lack of paper and low battery capacity etc.
♦Automatic adjustment of baseline for optimal recording
♦Standard input/output interface and RS232 communication interface for linking to
special network and setting up ECG database
2.2 List of Symbols
External output
External input
Equipment or part of CF type with defibrillator proof
Attention – general warning (see accompanying document)
Potential equalization

7
Mains supply
Battery indicator
Battery recharging indicator

8
Chapter 3 General Information
3.1Top Panel
=
Figure 3-1 Main Unit
Product Information:
1) Logo
2) Model
CM300
3) Brand Name
Three-channel Electrocardiograph
4) Classification Symbol
Equipment of CF type with defibrillator proof
LCD Screen
Control Panel
Recorder
RS232 Interface
External Input
/Output socket
Patient Cable Socket
Logo and Model
USB socket

9
3.1.1 LCD Screen
The LCD Screen specification: 320×240 dot single color LCD Screen
Figure 3-2 CM300 Main Interface
No. Name Explanation
A Lead State Diagram
Show the falling off state of the lead, white color
shows that the lead is connected and black point
shows the falling off state of the lead.
B Rhythm Lead Rhythm Lead Modes: Auto/Manual/Rhythm
C ID Patient ID
D Printing Speed The selection of printing speed: 5mm/s、10mm/s、
12.5mm/s、25mm/s、50mm/s
E Sex Sex: Male/Female
F
Gain Gain：AGC、2.5mm/mV、5mm/mV、10mm/mV、20mm/mV、
10/5mm/mV、20/10mm/mV
G Age Patient Age
H Heart Rate Display the current heart rate values

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I Time / Battery Display and current time and battery capacity
J
Prompt Information
Display prompt information (“demonstration, lead
off, printing, analyzing, sampling” and so on.)
K Waveform Area Current Waveform Display
L Diagram Area Lead State Diagram
3.1.2 Control Panel and Keys
1) Indicator Lamp
Mains supply indicator lamp: when mains supply is used, the lamp will be light.
Battery indicator lamp: when the built-in rechargeable Lithium battery is used,
the lamp will be light.
Battery recharging indicator lamp: when the battery is recharged, this lamp will
usually be light.
2) SENS Sensitivity Switch Key
The sensitivity switching order:
×10 mm/mV→×20 mm/mV →AGC→×2.5 mm/mV→×5 mm/mV
3) Recall Key( Just for the device with 320×240 dot single color LCD Screen)

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Press this key to review the patient records that saved in the record window.
4) 1mV Calibration Key
Under manual mode, this key can be pressed to record a 1mV calibration pulse at any time
while recording.
Under auto mode, this key can be pressed to review the electrocardiogram that recorded
last time.
5) MODE Mode Switch Key
This key can be pressed to select operation mode between Automatic mode, Manual mode
and OFF. The switching order of leads in each mode is listed in Table 3-1.
Note: The detailed automatic mode is set in MENU.
Table 3-1 Lead Switching order of Different Mode
Mode Switching Order (from left to right)
AUTO(Standard3/3)
AUTO(Cabrera3/3)
І/П/ШAVR/AVL/AVF V1/V2/V3 V4/V5/V6
AV L / I / - AV R II /AVF/ III V1/V2/V3 V4/V5/V6
MANUAL
In this mode, need to press Lead Switch Key to change the lead , the
lead switch order can be that of AUTO(Standard3/3) or
AUTO(Cabrera3/3), which is determined by settings of lead
sequence and print format in the MENU
6) LEAD Switch Key
Under manual mode, press the key to switch the lead.

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7) PRINT/STOP Key
Used to begin recording and stop recording.
8) ON/OFF Key
When the unit has been powered on, press this key to turn on it. Press again to turn off it.
9) MENU Key
Press this key to enter menu settings.
3.2 Patient Cable Socket and Signal Interface
There are sockets including the patient cable socket, RS232 socket, external input/output
socket and USB interface (reserved) at the right side of the main unit as Figure 3-1 shows.
1) Patient Cable Socket
: Applied part of type CF with defibrillator proof
: Attention – see accompanying document
Definition of corresponding pins:
Pin Signal Pin Signal Pin Signal
1 C2 (input) 6 RH (Shield) 11 F (input)
2 C3 (input) 7 NC 12 C1 (input)
3 C4 (input) 8 NC 13 NC
4 C5 (input) 9 R (input) 14 N or RF (input)
5 C6 (input) 10 L (input) 15 NC

13
2) RS232 Socket
WARNING :
RS232 interface is 1500V AC isolated intensity and the maximum voltage applied
should not exceed +15V DC.
Definition of corresponding pins:
Pin Signal Pin Signal Pin Signal
1 NC 4 NC 7 NC
2 RxD (input) 5 GND 8 NC
3 TxD (output) 6 NC 9 NC
3.3 Mains Connection and Switch
1) Potential Equalization Terminal
Potential equalization conductor provides a connection between the unit and the
potential equalization bus bar of the electrical installation.
2) Mains Supply Socket
POWER: alternating current supply socket
3) Power Switch
: Switch on
: Switch off
3.4 Bottom Panel
Potential Equalization Terminal
Mains Supply Socket

14
1) Battery Compartment
The battery label indicates the rated voltage and rated capacity of rechargeable Lithium battery
pack. Rated voltage: 14.8V, Rated capacity: 2000mAh.
Attention – general warning (see accompanying document)
WARNING :
Improper operation may cause the battery to be hot, ignited or exploded, and it may lead
to the decrease of battery’s capacity. Therefore, it is necessary to read the user manual
carefully and pay more attention to warning messages.
WARNING :
When leakage or foul smell found, stop using the battery immediately. If the leakage
liquid gets to your skin or cloth, cleanse it with clean water at once. If the leakage liquid
gets into your eyes, do not wipe them. Irrigate them with clean water first and go to see a
doctor immediately.
WARNING :
Only qualified service engineer authorized by our company can open the battery
Fuse
Battery Compartment
Label

15
compartment and replace the battery. And the battery of same model and specification
provided by manufacturer must be used.
2) Mains Supply Shift Switch
Mains supply with rated input voltage 230V (220V~240V) or 115V (100V~115V) can be
chosen by the shift switch according to local mains supply specification.
WARNING : Only qualified installation or service engineer can shift the mains shift
switch according to local mains supply.
3) Fuse
There are two same fuses installed on the bottom of the main unit. The specification is:
（T200mA 250V Ø5×20）
WARNING : Ruptured fused must only be replaced with the same type and rating as
the original.