S E -1

EDAN INSTRUMENTS, INC.
SE-1
Version No.: V1.1
Release Date: Sep.2007
Part No.: MS1R-19929-V1.1
EC Declaration of Conformity
Manufacturer: EDAN Instruments, Inc.
Addr: 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan
Shenzhen, 518067 P.R. China
European Representative: Shanghai International Holding Corp. GmbH (Europe)
Addr: Eiffestrasse 80 D-20537 Hamburg Germany
Product: Electrocardiograph
Model: SE-1
Classification (MDD, Annex IX): Class II a, Rule 10 According To Annex IX of the MDD
We herewith declare that the above mentioned product(s) meet the transposition into national
law, the provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
- as amended by Directive 98/79/EC on in vitro diagnostic medical devices.
All supporting documentation is retained at the premises of the manufacturer.
DIRECTIVES
General Applicable Directives:
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning
medical devices (MDD 93/42/EEC).
Standards applied: EN ISO14971: 2000, EN 60601-1: 1988, EN 60601-2-25: 1995, EN
60601-1-4: 1997, EN 60601-1-2: 2001, EN 60601-2-51: 2003, EN 1041: 1998, IEC/TR
60878-2003, EN 980: 1997, EN 60417-2-2000, ISO1000: 1998, EN ISO780: 1999.
Notified Body: TÜV SÜD Product Service GmbH, Ridlerstr 65, D-80339 MÜnchen, Germany.
Identification number
-I-
Copyright
Copyright © EDAN INSTRUMENTS, INC. 2007. All rights reserved.
Statements
Edan Instruments, Inc. (hereinafter called EDAN) 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. EDAN 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 EDAN.
Responsibility of the Manufacturer
EDAN only considers itself responsible for 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 EDAN;
♦
The electrical installation of the relevant room complies with safety standards;
♦
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.
Note: A NOTE provides useful information about a function or procedure.
-II-
Table of Contents
1 Safety Guidance...........................................................................................................................1
1.1 Safety Information...............................................................................................................1
1.2 Warnings and Cautions........................................................................................................1
1.2.1 Safety Warnings ........................................................................................................2
1.2.2 Battery Care Warnings ..............................................................................................3
1.2.3 General Cautions .......................................................................................................4
1.2.4 Cleaning & Disinfection Cautions ............................................................................5
2 Introduction .................................................................................................................................6
2.1 Function Features ................................................................................................................6
2.2 List of Symbols ...................................................................................................................7
3 General Information ...................................................................................................................8
3.1 Top Panel.............................................................................................................................8
3.1.1 LCD Screen ...............................................................................................................8
3.1.2 Control Panel and Keys.............................................................................................9
3.2 Patient Cable Socket and Signal Interface ........................................................................12
3.3 Mains Connection and Switch...........................................................................................14
3.4 Bottom Panel .....................................................................................................................15
4 Operation Preparations ............................................................................................................17
4.1 Power Supply ....................................................................................................................17
4.2 Loading/Replacing Record Paper......................................................................................18
4.3 Patient Cable Connection..................................................................................................19
4.4 Electrodes Connections .....................................................................................................20
4.5 Inspection before Switching on.........................................................................................22
5 Operation Instructions..............................................................................................................24
5.1 Switching On.....................................................................................................................24
5.2 Patient Information Input ..................................................................................................24
5.3 Menu Settings....................................................................................................................25
5.3.1 Filter Settings ..........................................................................................................26
5.3.2 Recording Settings ..................................................................................................26
5.3.3 Date and Time Settings ...........................................................................................27
5.3.4 Print Head Test ........................................................................................................27
5.3.5 External Input/Output Settings................................................................................27
5.3.6 Key and QRS Beep Settings....................................................................................28
5.3.7 Rhythm Lead Settings .............................................................................................28
-III-
5.4 Sensitivity Switching.........................................................................................................28
5.5 Automatic Mode Operation...............................................................................................28
5.6 Manual Mode ....................................................................................................................29
5.7 ECG Record ......................................................................................................................30
5.8 Switch Off .........................................................................................................................30
6 Alarm Information ....................................................................................................................31
7 Technical Specifications ............................................................................................................32
8 Cleaning, Care and Maintenance ............................................................................................35
8.1 Cleaning ............................................................................................................................35
8.1.1 Cleaning the Main Unit and Patient Cable..............................................................35
8.1.2 Cleaning the Electrodes...........................................................................................35
8.1.3 Cleaning the Print Head ..........................................................................................35
8.2 Disinfection .......................................................................................................................36
8.3 Care and Maintenance.......................................................................................................36
8.3.1 Recharge and Replacement of Battery....................................................................36
8.3.2 Record Paper ...........................................................................................................37
8.3.3 Maintenance of Main Unit, Patient Cable & Electrodes .........................................37
9 Service Warranty.......................................................................................................................40
10 Accessories and Ordering Information .................................................................................41
11 EMC Information - Guidance and Manufacture’s Declaration..........................................42
11.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS...............................42
11.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS ...............................43
11.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS
that are not LIFE-SUPPORTING..................................................................................44
11.4 Recommended Separation Distances ..............................................................................45
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SE-1 Single Channel Electrocardiograph User Manual
1 Safety Guidance
1.1 Safety Information
The design of the single channel electrocardiograph complies with the 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. Furthermore it is
defibrillation-proof.
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 І with internal power supply
2) Anti-electric-shock degree:
CF (with defibrillation-proof applied part)
3) Degree of protection against harmful
ingress of water:
Ordinary equipment (Sealed equipment without
liquid proof)
4) Disinfection/sterilization method:
Refer to this user manual for details
5) Safety degree 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.
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SE-1 Single Channel Electrocardiograph User Manual
1.2.1 Safety Warnings
WARNING
♦
:
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 EDAN 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 EDAN 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
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SE-1 Single Channel Electrocardiograph User Manual
conducting objects.
♦
Electrodes with defibrillation 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.
♦
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 EDAN 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
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SE-1 Single Channel Electrocardiograph User Manual
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.
♦
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
♦
:
A void liquid splash and excessive temperature. The temperature must be kept
between 5℃ and 40℃ while working. And it should be kept between -20 ℃ and
50℃ during transportation, and between -10 ℃ and 40℃ during 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
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SE-1 Single Channel Electrocardiograph User Manual
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).
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.
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SE-1 Single Channel Electrocardiograph User Manual
2 Introduction
SE-1 single channel electrocardiograph is a single channel digital ECG (electrocardiograph)
recorder with high performance.
One channel cardiogram can be previewed on the LCD (liquid crystal display) screen, and it
can be recorded by high-quality thermal printer. Moreover, real-time heart rate can be
displayed on the screen which can also be printed out on the record. Manual recording mode
and four automatic recording modes can be chosen conveniently. Either mains supply or
built-in rechargeable Lithium battery can be used as power supply.
Configurations: Main unit and accessories, including patient cable, chest electrodes, limb
electrodes, thermal print paper and power cord etc.
Intended use: The cardiogram and heart rate recorded by the electrocardiograph can help
doctors to analysis and diagnose heart disease or arrhythmia in hospitals. And its compact size
makes it suitable for use while visiting patients at home.
Note: It is not designed for internal use and direct cardiac application.
2.1 Function Features
♦
Low weight and compact size
♦
Touch key for easy operation
♦
LCD for single channel ECG preview before recording
♦
Four automatic recording modes and manual mode optional
♦
General menu for recording parameters setting
♦
Built-in rechargeable Lithium battery with high capacity
♦
Alarm information for lead off, lack of paper and weak battery etc.
♦
Thermal dot-matrix printer for high-resolution printout
♦
Automatic adjustment of baseline for optimal recording
♦
Selectable printing formats, standard single channel or single channel & rhythm lead
♦
Standard external input/output interface and RS232 communication interface for linking
to special network and setting up ECG database
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SE-1 Single Channel Electrocardiograph User Manual
2.2 List of Symbols
External output
External input
Equipment or part of CF type with defibrillation proof
Attention – general warning (see accompanying document)
Potential equalization
Mains supply (or indicator)
On (mains supply)
Off (mains supply)
Battery indicator
Battery recharging indicator
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SE-1 Single Channel Electrocardiograph User Manual
3 General Information
LCD Screen
Smart ECG SE-1
USB Interface
Record Paper
External
Recorder
Input/Output
Socket
RS232 Socket
Control Panel
Patient Cable Socket
Figure 3-1 Main Unit
(trademark) Smart ECG (trade name) SE-1 (model)
(classification symbol, equipment of CF type with defibrillation proof)
3.1 Top Panel
3.1.1 LCD Screen
The LCD screen can be revolved and settled firmly in different angle. Normally, the contents
displayed on the LCD screen include: (described from left to right in row order)
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SE-1 Single Channel Electrocardiograph User Manual
First Row:
♦
Operation mode (AUTO1, AUTO2, AUTO3, AUTO4 and MANU)
♦
II stop symbol, which will turn to
♦
Warning message (LD OFF, or PAPER? etc.)
♦
Current time
while recording
Second Row:
♦
Current lead (І, П, Ш, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6)
♦
Heart rate
(--, actual heart rate, or OVR message)
Third Row:
♦
Filter setting (FLT = AC, EMG, ALL, OFF)
♦
ECG
Fourth Row:
♦
Sensitivity (×1, ×2, AGC, · 25, · 5)
♦
Paper speed (25, 50)
♦
Battery capacity symbol (
♦
Display the ID, sex (M/F) and age group (CHD/ADL/OLD) while setting; and
,
,
,
)
“BATTERY WEAK” will be showed here when the battery capacity is weak.
3.1.2 Control Panel and Keys
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SE-1 Single Channel Electrocardiograph User Manual
1)
Indicator
Mains supply indicator: when mains supply is used, the indicator will be lit.
Battery indicator: when the built-in rechargeable lithium battery is used, the
indicator will be lit.
Battery recharging indicator: both the battery recharging indicator and mains
supply indicator will be lit after the mains power switch has been turned on.
After ON/OFF key being pressed, the battery recharging indicator will be black if
the battery capacity is full. However, if the battery capacity is not full, the battery
recharging indicator will be lit until the battery is full recharged, and after that the
battery recharging indicator will be black.
2) SENS (Sensitivity Switch Key)
The sensitivity switching order: ×1 → ×2 → AGC → · 25 → · 5
The ECG signal range which can be measured and recorded is different according to
different sensitivity, as the following list shows.
Options
Sensitivity
Signal range measured
×1
10mm/mV
-2.5mV ~ +2.5mV
×2
20mm/mV
-1.25mV ~ +1.25mV
AGC
Auto Gain Control
Adjust sensitivity automatically
· 25
2.5mm/mV
-10mV ~ +10mV
·5
5mm/mV
-5mV ~ +5mV
If the fluctuating range of the ECG signal is great, ‘AGC’ would be better to be chosen for
the sensitivity can be adjusted automatically under this mode.
3) RESET (Lead Locking Key)
Press this key to lock the lead while ECG recording. After that, the corresponding ECG
will be a line. It is always used to draw the baseline to zero quickly in the case of baseline
excursion in actual ECG recording. The lead will be unlocked automatically after 0.4
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SE-1 Single Channel Electrocardiograph User Manual
seconds.
4) 1mV Calibration Key
Under manual mode, this key can be pressed to record a 1mV calibration pulse at any time
while recording and the ECG trace will re-center.
5) MODE (Mode Switch Key)
There are four automatic modes and a manual mode. This key can be pressed to select
recording mode. The switching order of leads in each mode is listed in Table 3-1.
Table 3-1 Lead Switching order of Different Mode
Mode
Switching Order (from left to right)
MANU
І
П
Ш
AVR
AVL
AVF
V1
V2
V3
V4
V5
V6
AUTO1
І
П
Ш
AVR
AVL
AVF
V1
V2
V3
V4
V5
V6
AUTO2
AVL
І
AVR
П
AVF
Ш
V1
V2
V3
V4
V5
V6
AUTO3
І
AVR
V1
V4
П
AVL
V2
V5
Ш
AVF
V3
V6
AUTO4
2 channel automatic mode (AUTO1 + Rhythm Lead)
6) LEAD (Lead Switch Key)
Under manual mode, press the key to switch the lead in order.
7) PRINT/STOP Key
Used to begin recording and stop recording.
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SE-1 Single Channel Electrocardiograph User Manual
8) ON/OFF Key
When the unit has been powered on, press this key to turn on or turn off the
electrocardiograph.
9) MENU Key
Press MENU key to enter menu settings interface.
10) ID Setting Key
These two ID keys can be pressed to set the patient’s ID number. Press the upward arrow
key to increase ID number while press the downward arrow to decrease ID number on the
basis of current ID number.
11) M/F
Press M/F key to choose sex, male (M) or female (F).
12) AGE
Press AGE key to set age: child (CHD), adult (ADL) or elder (OLD).
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
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SE-1 Single Channel Electrocardiograph User Manual
: Defibrillation-proof applied part of type CF
: Attention – see accompanying document
Definition of corresponding pins:
Pin
Signal
Pin
Signal
Pin
Signal
1
C2 (input)
6
N or RF (input)
11
F (input)
2
C3 (input)
7
NC
12
NC
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
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) External Input/Output Socket
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SE-1 Single Channel Electrocardiograph User Manual
Definition of corresponding pins:
Pin
Signal
Pin
Signal
1
GND
4
GND
2
GND
5
ECG Signal (input)
3
GND
6
ECG Signal (output)
4) USB Interface (Reserved)
WARNING
♦
:
Accessory equipment connected to the interfaces must be certified
according to the respective IEC standards (e.g. IEC60950 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 input 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.
3.3 Mains Connection and Switch
Potential
Equalization Conductor
Mains Power Switch
Mains Supply Socket
At the left side of the main unit, there is the mains supply socket, power switch and potential
equalization conductor as the above figure shows.
1) Potential Equalization Conductor
Potential equalization conductor provides a connection between the unit and the
potential equalization bus bar of the electrical installation when necessary.
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SE-1 Single Channel Electrocardiograph User Manual
2) Mains Supply Socket
AC SOURCE: alternating current supply socket
3) Power Switch
: Switch on the mains power supply
: Switch off the mains power supply
3.4 Bottom Panel
Mains Supply Shift Switch
Battery Compartment
Fuse
Fuse Label
Label on Bottom
1) Battery Compartment
The battery label indicates the rated voltage and rated capacity of rechargeable Lithium
battery pack. Rated voltage: 14.4V, Rated capacity: 1600mAh.
Attention – general warning (see accompanying document)
WARNING
: Only qualified service engineer authorized by EDAN can open the
battery 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
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SE-1 Single Channel Electrocardiograph User Manual
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
showed on the fuse label: AC220V-240V: T200mA; AC100V-115V: T400mA; Φ5×20.
WARNING
: Ruptured fused must only be replaced with the same type and
rating as the original.
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SE-1 Single Channel Electrocardiograph User Manual
4 Operation Preparations
CAUTION
: Before use, the equipment, patient cable,electrodes and other
accessories should be checked. Replace it if there is any evident
defectiveness or aging which may impair the safety or performance.
And be sure that the equipment is in proper working condition.
4.1 Power Supply
WARNING
: 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.
The electrocardiograph can be powered either by mains supply or the built-in rechargeable
lithium battery pack.
1) Mains supply
The mains connection socket is on the left of the unit. If mains supply used, connect the
power cord to the socket first, and then connect the plug of the cord to the hospital grade
outlet.
Rated input voltage:
100V~115V or 220V~240V
Rated frequency:
50Hz/60Hz
Rated input power:
35VA
Make sure the mains supply meets the above requirements before power on. And then press
the mains power switch to power on the unit. Then the mains supply indicator ( ) will be
lit as well as the battery recharging indicator (
).
If the built-in rechargeable battery is weak when mains supply used, the battery recharging
indicator will be still lit after ON/OFF key pressed, which means the battery is recharged. If
the battery capacity if full, the recharging indicator will be black after ON/OFF key pressed.
2) Built-in rechargeable battery
While the built-in rechargeable lithium battery pack used, turn on the unit by pressing
ON/OFF key on control panel directly and the battery indicator (
The battery symbol
) will be lit.
will be displayed on the LCD screen. Because of the consumption
during storage and transport, the capacity of battery may not be full. If the symbol
and
the alarm information “BATTERY WEAK” are displayed, which means the battery
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SE-1 Single Channel Electrocardiograph User Manual
capacity is weak. And in this circumstance please recharge the battery first.
Note: Please refer to the maintenance section for how to recharge the battery. During
recharging the battery, the electrocardiograph can be powered by mains supply at the same
time.
WARNING
: Potential equalization conductor of the unit should be connected to
the potential equalization bus bar of the electrical installation when
necessary.
4.2 Loading/Replacing Record Paper
Rolled thermal paper with 50mm width is used as ECG record paper. When there is no record
paper loaded or it reaches the end of record paper, warning message “PAPER?” will be given
on the LCD screen. Under this circumstance, record paper should be loaded or replaced
immediately.
Casing
Paper Roller
Thermal Print Head
Scale
Roller Pin
Printer Platen
Groove
Paper Tray
Loading/Replacing Procedures:
1)
Place fingers under the flange of the recorder casing, pull upwards directly to release
the casing;
2)
Take out the paper roller, and remove remain paper from the left of roller if necessary;
3)
Take off the wrapper of the new thermal paper roll, and then put through the roller from
the left with the paper’s grid side facing downward.
4)
Then place the paper and roller gently in the paper tray with the roller pin on the roller’s
left side facing to the groove;
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5)
Pull about 2cm of the paper out, and put down the recorder casing with the paper’s side
edges in parallel with the scale on the surface of casing;
6)
Secure the casing by pressing it firmly.
4.3 Patient Cable Connection
Patient cable includes two parts, main cable and lead wires with associated electrode
connectors. The electrode connectors can be distinguished from the color and identifier on
them.
Model of Patient Cable
Main Cable
Lead Wires
Label of Patient Cable
Electrode Connectors
Connector
Connect Main Cable: Plug the connector of main cable into the patient cable socket on the
right side of the unit, and secure the screw.
WARNING
♦
:
This product is CF classified and defibrillation protected only when the original
patient cable is used. However, as a safety precaution when possible, remove
electrodes before defibrillation.
♦
Precautions must be observed when using high frequency devices. Use the
special high frequency EDAN patient cable to avoid possible signal interference
during ECG acquisition.
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4.4 Electrodes Connections
Chest Electrode:
Suction Bulb
Electrode
Metal Cup
Limb Electrode:
Electrode
Reed
Clamp
The identifier and color code of electrodes used complies with IEC requirements. In order to
avoid incorrect connections, the electrode identifier and color code is specified in Table 4-1.
Moreover the equivalent code according to American requirements is given too.
Table 4-1 Electrodes, Identifier and Color Code
European
Electrodes
Identifier
American
Color code
Identifier
Color code
Right arm
R
Red
RA
White
Left arm
L
Yellow
LA
Black
Right leg
N or RF
Black
RL
Green
Left leg
F
Green
LL
Red
Chest 1
C1
White/red
V1
Brown/red
Chest 2
C2
White/yellow
V2
Brown/yellow
Chest 3
C3
White/green
V3
Brown/green
Chest 4
C4
White/brown
V4
Brown/ blue
Chest 5
C5
White/black
V5
Brown/orange
Chest 6
C6
White/violet
V6
Brown/violet
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As the following figure shows, the chest electrodes’ position on body surface is
C1
C4
C2
C6
C3
C5
C1: Fourth intercostals space at right border of sternum
C2: Fourth intercostals space at left border of sternum
C3: Fifth rib between C2 and C4
C4: Fifth intercostals space on left midclavicular line
C5: Left anterior axillary line at the horizontal level of C4
C6: Left midaxillary line at the horizontal level of C4
The contacting resistance between the patient and the electrode will affect the quality of ECG
greatly. In order to get a high-quality ECG, the skin/electrode resistance must be minimized
while connecting electrodes.
Chest electrodes connection:
1)
Ensure the electrodes to be clean firstly;
2)
Align all lead wires of patient cable to avoid twisting, and connect the associated
electrode connectors with corresponding electrodes according to the color and
identifier;
3)
Clean electrode area on chest surface with alcohol;
4)
Daub the round area of 25mm diameter on each electrode site with gel evenly;
5)
Place a small mount of gel on the brim of chest electrode’s metal cup;
6)
Place the electrode on chest electrode site and squeeze the suction bulb. Unclench it and
then the electrode is adsorbed on chest. Attach all chest electrodes in the same way.
Limb electrodes connection:
1)
Ensure the electrodes to be clean firstly;
2)
Align lead wires of patient cable to avoid twisting, and connect the electrode connectors
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to corresponding electrodes according to the color and identifier;
3)
Clean electrode area on a short distance above the ankle or wrist with alcohol;
4)
Daub the electrode area on limb with gel evenly;
5)
Place a small amount of gel on the metal part of limb electrode clamp;
6)
Connect the electrode to limb, and be sure that the metal part be placed on the electrode
area above the ankle or wrist. Attach all limb electrodes in the same way.
WARNING
♦
:
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.
♦
There is no danger when using the electrocardiograph with electrical
stimulation equipment. However, the stimulation units should only be used at
a sufficient distance from the electrodes .If in doubt, the patient should be
disconnected from the device.
♦
Electrodes with defibrillation protection should be used while defibrillating.
♦
Do not touch the unit casing during defibrillation.
4.5 Inspection before Switching on
In order to avoid safety hazards and get good ECG record, the following inspection procedures
are recommended before turning on the unit and beginning operation.
1) Environment:
♦
Check and make sure that there is no electromagnetic interference source around the
equipment, especially large medical electrical equipment such as electrosurgical
equipment, radiological equipment and magnetic resonance imaging equipment etc.
Switch off these devices when necessary.
♦
Keep the examination room warm to avoid muscle action voltages in ECG signal
caused by cold.
2) Power Supply:
♦
If mains power used, please check whether the power cord has been connected to the
unit well. And the grounded three-phase outlet should be used.
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♦
Recharge the battery first before use when the battery capacity is weak.
3) Patient Cable:
♦
Check whether the patient cable has been connected to the unit firmly, and keep it far
away from the power cord.
4) Electrodes:
♦
Check whether all electrodes have been connected to lead wires of patient cable
correctly according to the identifier and color.
♦
Be sure that all electrodes have been connected to the patient correctly.
♦
Ensure that the chest electrodes haven’t contacted with each other.
5) Recorder Paper:
♦
Ensure that there is enough recorder paper loaded correctly.
♦
Make sure the case of the recorder has been secured.
6) Patient:
♦
The patient should not contact with conducting object such as earth, and metal part of
bed etc.
♦
Ensure the patient is warm and relaxed, and breathe calmly.
WARNING
: 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 using.
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5 Operation Instructions
5.1 Switching On
♦
While mains supply used, press the power switch on the left side of the unit first, and the
mains supply indicator (
) is lit. Then press ON/OFF key on the control panel to turn on
the unit. Equipment information such as name, manufacturer and version etc., will be
displayed on LCD screen after self-test. Then the electrocardiograph is ready for
examination and recording.
♦
While built-in rechargeable lithium battery used, press ON/OFF key on the control panel
directly to turn on the unit, and then the battery indicator (
) is lit. After self-test, the
electrocardiograph is ready for examination and recording.
5.2 Patient Information Input
II
AUTO 1
І
10 : 50
NO
FLT = ALL
×1 25
1)
ECG256
MALE
ADL
ID Number
Press ID (upward arrow) key to increase ID number or ID (downward arrow) to decrease it
on the basis of current number. The number will be displayed for one or two seconds in
the last row on LCD screen such as ‘ECG 256’ in the above figure.
Under the following circumstances, the ID number may increase automatically:
♦
Under automatic recording mode, PRINT/STOP key can be pressed to record the ECG
automatically. When one full lead ECG record finished, or PRINT/STOP key is
pressed during the recording course, the ID number will automatically increase one
when begin recording again.
♦
Under manual recording mode, press PRINT/STOP key to record ECG. If
PRINT/STOP key is pressed during the course of recording, the ID number will
automatically increase one when begin recording again.
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2)
SEX
Press M/F key to set the sex: female or male, which will be displayed for one or two
seconds in the last row on LCD screen.
3)
AGE
Patients are divided into three groups based on age: CHD (child), ADL (adult), OLD
(elder). Press AGE key to set the age group, which will be displayed for one or two
seconds in the right down corner of LCD screen.
Note: The patient information mentioned above can not be set or changed during the
course of recording.
5.3 Menu Settings
19 items in the menu are listed in Table 5-1. In the Options column, the value double
underlined is the default settings.
Table 5-1 Menu Items
No.
Menu Items
Options
1
FILTER SETTING
AC, ALL, OFF, EMG
2
PWAVE START
ON, OFF
3
RECORD LENGTH
2, 3, 4, …, 11, 12
4
RECORD COUNT
SECOND, QRS
5
RECORD SPEED
25, 50 (unit: mm/s)
6
HEARTRATE PRINT
ON, OFF
7
YEAR
0~99
8
MONTH
1~12
9
DAY
1~31
10
HOUR
0~23
11
MINUTE
0~59
12
PRINT HEAD TEST
ON, OFF
13
DEFAULT SETTING
NO, RESTORE
14
EXTINPUT RECORD
ON, OFF
15
KEY BEEP
ON, OFF
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16
QRS BEEP
ON, OFF
17
RHYTHM LEAD
І, П, Ш, AVR, AVL, AVF
V1, V2, V3, V4, V5, V6
18
LOWPASS FILTER
NO, 75HZ, 100HZ, 150HZ
19
LANGUAGE
ENG, CHN
Setting Method:
1) Press MEMU key to enter menu settings displayed as the following figure;
FILTER SETTING
: ALL
PWAVE START
: ON
RECORD LENGTH
:3
RECORD COUNT
: SECOND
2) Press ID key (upward or downward) to move the arrow at the right of LCD screen to the
item to be changed. Take ‘FILTER SETTING’ as for example. The arrow
item of FILTER SETTING.
stop at the
3) Then press M/F key or AGE key to choose the setting options (EMG, AC, ALL, OFF);
4) Repeat 2) and 3) to set other items in the same way;
5) After modifying the items which need to be changed, press MENU key again to quit the
menu interface with new settings.
Note: Set the DEFAULT SETTING as RESTORE, and then the defaults of all items will
be reloaded except date, time and language.
Descriptions of some items and their settings are given in the following sections.
5.3.1 Filter Settings
The filter can be chosen among EMG, AC, ALL (both of EMG and AC) or OFF (no filter).
When choose OFF, the filter will not work. Generally, ALL is recommended to be set in order
to get better ECG record.
5.3.2 Recording Settings
Recording settings includes start, length, count unit, speed and contents. Such as:
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PWAVE START
: ON
RECORD LENGTH
:3
RECORD COUNT
: SECOND
RECORD SPEED
: 25
HEARTRATE PRINT
: ON
Take the above settings as example, the ECG will be recorded from P wave, and the printing
speed is 25mm/s. The record length of each lead is 3 seconds. And the heart rate will be printed
out at the bottom of each lead recording beginning.
When QRS is taken as recording count unit, the record length will be 3 periods of QRS wave.
Note: The record duration of each lead must be longer than 2 seconds. So when QRS is chosen
to be the count unit, no matter how long the record length is, if the period of QRS wave is too
short, the electrocardiograph will keep recording for 2 seconds.
5.3.3 Date and Time Settings
The date and time on LCD screen and ECG record can be set in the following items:
YEAR
:4
MONTH
:8
DAY
:6
HOUR
: 14
MINUTE
: 25
As the above settings, the date & time is Aug. 6th, 2004, 14:25 PM. And it will be printed out as
2004-8-6-14:25 on the record.
5.3.4 Print Head Test
PRINT HEAD TEST
: OFF
Print head test is used to check whether the print head can work normally or not. The default
status of print head test is OFF. Turn on this item when the print paper has been loaded. Then
the triangle wave in effective paper width will be printed out. The status of print head can be
estimated from this triangle wave.
5.3.5 External Input/Output Settings
External input/output signal interface is equipped in the electrocardiograph, through which
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ECG signal from external equipment can be received, and ECG signal detected by the
electrocardiograph can be transmitted to other external equipment. Set the EXTINPUT
RECORD as ON to turn on the function and OFF to turn off.
5.3.6 Key and QRS Beep Settings
KEY BEEP
: ON
QRS BEEP
: OFF
When KEY BEEP is ON, a short beep sound will be heard when press the control key. When
KEY BEEP is OFF, there is no sound while pressing the key.
During the course of ECG recording, if QRS BEEP is ON, the unit will make a short beep
sound when an R wave has been detected. So in normal recording, continuous and regular
sound of beep will be heard.
5.3.7 Rhythm Lead Settings
:П
RHYTHM LEAD
Under AUTO 4 mode, ECG of one channel and a rhythm channel lead can be recorded. The
rhythm lead can be anyone of 12 standard leads: І, П, Ш, AVR, AVL, AVF, V1, V2, V3, V4, V5,
and V6.
5.4 Sensitivity Switching
There are five options of sensitivity:
×1 (10mm/mV) → ×2 (20mm/mV) → AGC → · 25 (2.5mm/mV) → · 5 (5mm/mV)
Press
key to choose the appropriate sensitivity to achieve better ECG record according
to the signal range that can be measured. Refer to Section 3.1.2 for details about signal range
under different sensitivity.
This key can be pressed during the course of examination or recording under manual mode
while it is ineffective during the course of recording under automatic mode.
5.5 Automatic Mode Operation
Four automatic recording modes are provided by this electrocardiograph, AUTO 1, AUTO 2,
AUTO 3 and AUTO4. Two channels, including a rhythm lead, can be recorded together under
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AUTO 4 mode. The lead switching orders under different modes are listed in Table 3-1 in
Section 3.1.2.
Under automatic mode, leads will be switched in order automatically while recording ECG.
That means when ECG signal from one lead has been recorded for the set length such as 3
seconds, it will be switched to the next lead and begin recording another ECG signal. And there
is a pause for several seconds before recording the next ECG signal under the modes of
AUTO1, AUTO2 and AUTO3. Moreover, a 1mV calibration pulse will be printed on the record
automatically before ECG of each lead.
Operation Procedures:
1) Press MODE key to choose automatic mode, which will be displayed in the left top
corner on LCD screen;
2) If AUTO4 has been chosen, rhythm lead can be selected by pressing MENU key to set
RHYTHM LEAD. The rhythm lead can also be set before selecting mode. Moreover
there is no pause between different leads while recording.
3) Then press PRINT/STOP key to begin recording. The symbol
means ECG is
recorded now. It will stop automatically after a full 12-lead ECG printed out.
Pressing PRINT/STOP again during the course of recording can stop printing. However, when
beginning record later, ECG will be recorded in order from the first lead again. And ID number
will increase one automatically. If the ID number needs not to be changed, ID key should be
pressed to adjust it before recording.
Note: Recording mode can not be changed during the course of printing. Stop
recording before choose another recording mode.
5.6 Manual Mode
Under manual mode, users can determine the lead to be recorded and set the record settings or
other parameters according to different leads.
Operation Procedures:
1) Press MODE key to choose MANU mode, which can be discerned by the identifier on
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the left corner of LCD screen as MANU;
2) Press LEAD key left arrow or right arrow key to select the lead to be recorded;
3) Press MENU key to set the record settings or other settings. After setting, press MENU
key again to confirm the settings;
4) Then press PRINT/STOP key to begin recording;
5) 1mV calibration key can be pressed to print out 1mV pulse wave in the record while
ECG recording;
6) Press PRINT/STOP key to stop printing after finishing ECG record.
Note: LEAD left and right arrow key can be pressed to switch the lead during the
course of recording.
5.7 ECG Record
As the above figure shows, the ECG record includes: date and time, ID number, name (written
by doctor later), sex, age, sensitivity, paper speed, filter settings, lead name, 1mV calibration
pulse, ECG, heart rate, manufacturer and model of the equipment.
At the beginning of each lead’s ECG, lead name and 1mV calibration pulse is printed. On the
top of the ECG record of each lead, sensitivity is marked. The sensitivity may be different, for
it can be changed during the course of recording.
5.8 Switch Off
When built-in battery pack used, press ON/OFF key directly to turn off the unit after finishing
ECG record.
When mains supply used, press ON/OFF key first after finishing ECG record and then switch
off the mains supply by pressing the switch on the left side of the unit. Pull off the plug from
the outlet last.
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6 Alarm Information
Alarm information will be displayed on the LCD screen when there is something wrong. Alarm
information provided by the electrocardiograph and corresponding cause is listed in Table 6-1.
Table 6-1 Alarm Information and Causes
Alarm Information
Causes
LD OFF
Electrodes fall off from the patient or the patient cable falls off from
the unit.
PAPER?
Record paper has not been loaded or it has been used out.
BATTERY WEAK
The built-in battery is weak.
--
The heart rate is over 250BPM.
--
The heart rate is below 30BPM.
--
Heart rate has not been detected in 2 seconds.
OVR
The ECG signal exceeds the measuring range under certain
sensitivity.
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7 Technical Specifications
1) MDD93/42/EEC
2) IEC60601-1
3) EN 60601-1-4
Safety Standards
4) IEC60601-2-25
5) EN 60601-2-51
6) EN ISO14971
7) EN 55011
8) ANSI/AAMI EC-11
Anti-electric-shock type:
Class І with internal power supply
Anti-electric-shock degree:
Type CF with defibrillation proof
Degree of protection
harmful ingress of water:
Classification
Ordinary equipment (Sealed
equipment without liquid proof)
Disinfection/sterilization method:
Refer to the user manual for details
Degree of safety of application in
the presence of flammable gas:
Equipment not suitable for use in the
presence of flammable gas
Working mode:
Continuous operation
EMC:
Group І, type A
Dimensions
288mm×210mm×70mm
Weight
About 2.3kg
Display
192 × 64 pixels color LCD
Transport
Storage
Working
-20℃~50℃
-10℃~40℃
5℃~40℃
Relative
25%~95%
25%~95%
25%~85%
Humidity
No Condensation
No Condensation
No Condensation
700hPa ~1060hPa
700hPa ~1060hPa
860hPa ~1060hPa
Temperature
Environment
against
Atmospheric
Pressure
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Rated input voltage =100V~115V/220V~240V
Mains Supply
Rated frequency = 50/60Hz
Rated input power = 35VA
Rated voltage = 14.4V
Rated capacity = 1600mAh
Power Supply
Built-in Lithium Battery
Charge mode: Constant current/voltage
Pack
Charge current (standard) = 0.2C5A (320mA)
Charge voltage (standard) = (16.8±0.1V)
Cycle life ≥ 300 times
Power Consumption
35VA
Fuse
T200mA Ø5×20 or T400mA Ø5×20
Recorder
Thermal dot-matrix printer
Dot structure: 384 dots/line
Thermal Print Head
Dot pitch: 0.125mm (8 dots/mm)
Dot size: 0.125mm×0.12mm
Recording
HR
Recognition
ECG Unit
Record Paper
Rolled thermal paper
Paper Width
50mm
Effective Width
48mm
Paper Speed
25mm/s, 50mm/s
Accuracy
±3%
Technique
Peak-peak detection
HR Range
30BMP~250BMP
Accuracy
±1BMP
Leads:
12 standard leads
Acquisition Mode:
One lead
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A/D Resolution:
12 digit
Time Constant:
≥3.2s
Frequency Response:
0.05Hz ~ 150Hz
Sensitivity:
2.5, 5, 10, 20 (mm/mV)
Input Impedance:
≥10M Ω
Input Circuit Current:
≤50nA
Input Voltage Range
<±5 mVpp
Calibration Voltage:
1mV±3%
Noise:
<15 µ Vp-p
EMG Filter: 35Hz (-3dB)
Filter
AC/DFT Filter: 50Hz/60Hz (-20dB)
CMRR
>90dB; >100dB (with AC filter)
Patient Leakage Current:
<10 µ A (220V~240V)
Patient Auxiliary Current:
<0.1 µ A (DC)
Dielectric Strength:
4000V rms
External
Input (Single ended)
≥100k Ω ; Sensitivity10mm/V±5%;
Output (Single ended)
≤100 Ω ; Sensitivity1V/mV±5%;
Input/Output
(Optional)
Communication
Interface
RS232 (Refer to Section 3.2 for details)
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8 Cleaning, Care and Maintenance
8.1 Cleaning
CAUTION
: Turn off the power before cleaning and disinfection. If mains supply
used, the unit should be switched off first and the power cord should
be plugged out of the outlet.
8.1.1 Cleaning the Main Unit and Patient Cable
The surface of the main unit and patient cable can be wiped with a clean soft cloth damped
in soapy water or non-caustic neutral detergent. After that, remove detergent remainder with
a clean dry cloth.
8.1.2 Cleaning the Electrodes
Remove the remainder gel from the electrodes with a clean soft cloth first. For chest
electrodes, take the suction bulb and mental cup of chest electrodes apart, and for limb
electrodes take the clamp and the metal part of the limb electrodes apart. Clean them in
warm water and be sure there is no remainder gel. Dry the electrodes with a clean dry cloth
or air dry naturally.
8.1.3 Cleaning the Print Head
Dirty and soiled thermal print head will deteriorate the record definition. So it should be
cleaned at least once a month regularly.
Open the recorder casing and remove the record paper. Wipe the print head and printer
platen gently with a clean soft cloth damped in 75% alcohol. For stubborn stain, soak it with
a little alcohol first and wipe it off with a clean soft cloth. After air dried, load the record
paper and shut the casing of the recorder.
CAUTION
♦
:
Prevent the detergent from seeping into the main unit while cleaning. 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 and thermal print head.
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8.2 Disinfection
To avoid permanent damage to the equipment, disinfection can be performed only when it has
been considered as necessary according to your hospital’s regulations.
Before disinfection clean the equipment first. Then wipe the surface of the unit and patient
cable with 70% isopropyl alcohol. Wipe the surface of electrodes with 70% alcohol or
isopropyl alcohol. Never immerse the unit, cable or electrodes into disinfectant solution.
CAUTION
: Do not use chloric disinfectant such as chloride and sodium
hypochlorite etc.
8.3 Care and Maintenance
8.3.1 Recharge and Replacement of Battery
1) Capacity Identification
Current capacity of the rechargeable battery can be identified according to the battery
symbol in the last row on LCD screen.
: Full capacity
: Not full but enough
: Capacity is limited, and recharge should be taken into account
: Battery is weak; and warning message “BATTERY WEAK” will be displayed on
LCD screen. The battery should be recharged immediately
2) Recharge
The electrocardiograph is equipped with recharge control circuit together with built-in
rechargeable lithium battery. Once the main unit is connected to mains supply with power
cord, the battery will be recharged automatically. And then the battery recharge indicator
(
) and the mains supply indicator (
) will be lit at the same time. When the capacity of
battery is full, the battery recharge indicator (
) will be black.
Because of the capacity consumption during storage and transport, the capacity of battery is
not full while being used at the first time. Battery recharge is recommended before first
usage.
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3) Replacement
When the useful life of battery is over, or foul smell and leakage has been found, please
contact with manufacturer or local distributor for replacement of battery.
WARNING
♦
:
Only qualified service engineer authorized by EDAN can open the battery
compartment and replace the battery. And the battery of same model and
specification provided by manufacturer must be used.
♦
Danger of explosion -- Do not reverse the anode and cathode when
connecting the battery.
♦
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.
8.3.2 Record Paper
Storage requirements:
♦
Record paper should be stored in dry, dark and cool area, avoiding excessive
temperature, humidity and sunshine.
♦
Do not put the paper under fluorescence for long time.
♦
Be sure that there is no polyvinyl chloride or other chemicals in the storage
environment, which will lead to color change of the paper.
♦
Do not overlap the recorded paper long time, or else the ECG record may trans-print
each other.
Note: Record paper provided by manufacturer should be used. Other paper may
shorten thermal print head’s life. And the deteriorated print head may lead to
illegible ECG record and block the advance of paper etc.
8.3.3 Maintenance of Main Unit, Patient Cable & Electrodes
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.
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e) Test the protection earth resistance according IEC 601-1/1988: Limit 0.2ohm.
f) Test the earth leakage current according IEC 601-1/1988: Limit: NC 500uA, SFC
1000uA.
g) Test the patient leakage current according IEC 601-1/1988: Limit: 10uA (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).
The leakage current should never exceed the limit. 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.
WARNING
: Failure on the part of the responsible individual hospital or
institution employing the use of this equipment to implement a
satisfactory maintenance schedule may cause undue equipment
failure and possible health hazards.
1) Main Unit
♦
Avoid excessive temperature, sunshine, humidity and dirt.
♦
Put on the dustproof coat after use and prevent from shaking violently when moving it
to another place.
♦
Prevent any liquid from seeping into the equipment, for it will affect the safety and
performance of the electrocardiograph.
2) Patient Cable
♦
Integrity of patient cable, including main cable and lead wires, should be checked
regularly. And be sure that it is conductible.
♦
Do not drag or twist the patient cable with excessive stress while using. Hold the
connector plugs instead of the cable when connect or disconnect the patient cable.
♦
Align the patient cable to avoid twisting, knotting or crooking in closed angle while
using.
♦
Store the lead wires in bigger wheel to prevent any people from stumbling.
♦
Once damage or aging of the cable patient has been found, replace it with a new one
immediately.
3) Electrodes
♦
Electrodes must be cleansed after use and be sure there is no remainder gel on them.
♦
Keep the suction bulb of chest electrode from sunshine and excessive temperature.
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SE-1 Single Channel Electrocardiograph User Manual
♦
After long-term use, the surface of electrodes will be oxidized because of erosion and
other causes. By this time, electrodes should be replaced to achieve high-quality ECG.
CAUTION
: The equipment and reusable accessories can be sent back to the
manufacturer for recycling or proper disposal after their useful lives.
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SE-1 Single Channel Electrocardiograph User Manual
9 Service Warranty
Material and Manufacture
The warranty period for the main unit and the accessories is 12 months from the date of
shipment.
EDAN warrant that there’s no defect in material and manufacture. During the warranty
period, EDAN will repair or replace the defective part free if the defect has been confirmed
as material or manufacture defect.
Software or Firmware
For the software or firmware installed, EDAN will replace the software or firmware free if
the defect has been confirmed during 12 months from the date of shipment. But EDAN can
not warrant it will not interrupt the use of the product.
CAUTION
: All services must be done by the engineers authorized by EDAN.
Limit of Warranty
The charges of freight and others are excluded under warranty.
The warranty is void in the case of
♦
Assembly, extensions, readjustments of any parts;
♦
Modification and repair by unauthorized persons;
♦
Subsequent damage caused by improper use or maintenance;
♦
Replacement or remove of the label of serial number and manufacturer.
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SE-1 Single Channel Electrocardiograph User Manual
10 Accessories and Ordering Information
The accompanying accessories of the electrocardiograph are listed in Table 10-1.
Table 10-1 Accessories List
No.
Accessory
Manufacturer / EDAN Part No.
1
Power cord
EDAN / M13-36014
2
Patient cable
Tsingtao KOHDEN / MS1-18503
3
Chest electrodes
Tsingtao KOHDEN / MS1-18504
4
Limb electrodes
Tsingtao KOHDEN / MS1-18505
5
Paper roller
EDAN / MS1-19927
6
Thermal paper
EDAN / MS1-19917
The following accessories can also be ordered according to some special usage.
No.
Accessory
Manufacturer / Part No.
1
Earth wire
EDAN / MS2-01952
2
Input/output signal cable
EDAN / MS1-19907
3
Cable for defibrillator-proof electrodes
EDAN / MS1-20035
4
ECG Electrodes
MSB LIMITED/ M15-40016
The main unit and accessories are available by contacting the manufacturer or your local
distributor.
Manufacturer:
EDAN INSTRUMENTS, INC.
Address: 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan
Shenzhen, 518067 P.R. China
Zip code: 518067
Tel: +86-755-26882220
Fax: +86-755-26882223
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SE-1 Single Channel Electrocardiograph User Manual
11 EMC Information - Guidance and Manufacture’s Declaration
11.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The Electrocardiograph is intended for use in the electromagnetic environment specified below. The user of the
Electrocardiograph should assure that it is used in such and environment.
Emission test
Electromagnetic environment – guidance
Compliance
The Electrocardiograph uses RF energy only for its
RF emissions
CISPR 11
Group 1
internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emission
CISPR 11
Harmonic emissions
IEC 61000-3-2
Class A
The Electrocardiograph is suitable for use in all
Class A
directly connected to the public low-voltage
Voltage fluctuations/
flicker emissions
establishments other than domestic and those
power supply network that supplies building used
Complies
for domestic purposes.
IEC 61000-3-3
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SE-1 Single Channel Electrocardiograph User Manual
11.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The Electrocardiograph is intended for use in the electromagnetic environment specified below. The user of
Electrocardiograph should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment
- guidance
Electrostatic
±6 kV contact
±4 kV contact
It is recommended the use of
discharge (ESD)
±8 kV air
±6 kV air
antistatic materials. If floor are
covered with synthetic material,
IEC 61000-4-2
the relative humidity should be at
least 50%.
Electrical fast
±2 kV for power supply
±1 kV for power supply
It is recommended the use of
transient/burst
lines
lines
filters on power input lines and
IEC 61000-4-4
±1 kV for input/output
±0.5 kV for
enough separation between
lines
input/output lines
signal lines and power lines.
Surge
±1 kV differential
±1 kV differential mode
Mains power quality should be
IEC 61000-4-5
mode
±2 kV common mode
that of a typical commercial or
±2 kV common mode
hospital environment.
Voltage dips,
<5% UT
<5% UT
Mains power quality should be
short
(>95% dip in UT)
(>95% dip in UT)
that of a typical commercial or
interruptions and
for 0.5 cycle
for 0.5 cycle
hospital environment.
on power supply
40% UT
40% UT
input lines
(60% dip in UT)
(60% dip in UT)
IEC 61000-4-11
for 5 cycles
for 5 cycles
70% UT
70% UT
(30% dip in UT)
(30% dip in UT)
for 25 cycles
for 25 cycles
<5% UT
<5% UT
(>95% dip in UT)
(>95% dip in UT)
for 5 sec
for 5 sec
3A/m
3A/m
voltage variations
Power frequency
Power frequency magnetic fields
(50Hz) magnetic
should be at levels characteristic
field
of a typical location in a typical
IEC 61000-4-8
commercial or hospital
environment.
NOTE
UT is the a.c. mains voltage prior to application of the test level.
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SE-1 Single Channel Electrocardiograph User Manual
11.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user
of Electrocardiograph should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
Electrocardiograph, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
 3.5 
d =  P
 V1 
1V
3 V/m
 3.5 
d =  P
 E1 
80 MHz to 800 MHz
7
d =  P
 E1 
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
a
determined by an electromagnetic site survey, should
be less than the compliance level in each frequency
b
range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Electrocardiograph is used exceeds the
applicable RF compliance level above, the Electrocardiograph should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
Electrocardiograph.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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SE-1 Single Channel Electrocardiograph User Manual
11.4 Recommended Separation Distances
Recommended separation distances between
portable and mobile RF communications equipment and electrocardiograph
The electrocardiograph is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the electrocardiograph can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the electrocardiograph as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum
(m)
output power of
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
transmitter
(W)
 3.5 
d =  P
 V1 
 3.5 
d =  P
 E1 
7
d =  P
 E1 
0.01
0.35
0.117
0.233
0.1
1.11
0.369
0.738
1
3.5
1.17
2.33
10
11.1
3.69
7.38
100
35
11.7
23.3
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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EDAN INSTRUMENTS, INC.
3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan
Shenzhen, 518067 P.R. China
TEL:86-755-26882220
FAX: +86-755-26882223