This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User’s operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
I
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
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 regarding a function or a procedure.
SE-3&SE-300 Series Electrocardiograph User Manual Safety Guidance
Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of the 3-Channel
Electrocardiograph.
1.1 Intended Use/Indications for Use
The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and
pediatric patients (beginning at birth through 21 years of age) through body surface ECG
electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities
by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel
Electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with
measurements and interpretive statements is offered to clinicians on an advisory basis only.
WARNING
1. This equipment is not designed for intracardiac use or direct cardiac application.
2. This equipment is not intended for home use.
3. This equipment is not intended for treatment or monitoring.
4. This equipment is intended for use on adult and pediatric patients only.
5. The results given by the equipment should be examined based on the overall clinical
condition of the patient, and they can not substitute for regular checking.
1.2 Warnings and Cautions
In order to use the electrocardiograph safely and effectively, and avoid 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-3&SE-300 Series Electrocardiograph User Manual Safety Guidance
1.2.1 Safety Warnings
WARNING
1. The electrocardiograph is provided for the use of qualified physicians or personnel
professionally trained. They should be familiar with the contents of this user manual
before operation.
2. Only qualified service engineers can install this equipment, and only service
engineers authorized by the manufacturer can open the shell. Otherwise, safety
hazards may happen.
3. Only qualified installation or service engineers can shift the mains supply shift switch
(100V-115V~/220V-240V~) according to local mains supply specifications.
4. The results given by the equipment should be examined based on the overall clinical
condition of the patient, and it can not substitute for regular checking.
5. This device is not intended for treatment or monitoring.
6. The EQUIPMENT is protected against malfunction caused by electrosurgery
according to the clause 36.202.101 in the IEC60601-2-25.
7. Electrodes of dissimilar metals should not be used; it may cause a high polarization
voltage.
8. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of
flammable anesthetic mixture with oxygen or other flammable agents.
9. 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.
10. If the integrity of the external protective conductor is in doubt, the equipment should
be operated by using the built-in rechargeable battery.
11. Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.
12. This equipment is not designed for direct cardiac application.
13. Only the patient cable and other accessories supplied by the manufacturer can be
used. Or else, the performance and electric shock protection can not be guaranteed.
The electrocardiograph has been safety tested with the recommended accessories,
peripherals, and leads, and no hazard is found when the electrocardiograph is
operated with cardiac pacemakers or other stimulators.
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SE-3&SE-300 Series Electrocardiograph User Manual Safety Guidance
WARNING
14. The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
15. Make sure that all electrodes are connected to the patient correctly before operation.
16. Ensure that the conductive parts of electrodes and associated connectors, including
neutral electrode, do not come into contact with earth or any other conducting
objects.
17. To avoid a polarization or DC offset voltage, use non-polarizing electrodes(which will
not form a DC offset voltage when subjected to a DC current) such as
silver/silver-chloride types if there is a situation where there is a likelihood that a
defibrillation procedure will be necessary.
18. There is no danger for patients with pacemakers. However, if a pacemaker is used,
the results given by the equipment may be invalid, or lose the clinical significance.
19. Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.
20. Do not touch accessible parts of electrical equipment and the patient simultaneously.
21. In order to avoid being burned, please keep the electrodes far away from the radio
knife while using electrosurgical equipment.
22. Disposable electrodes must be used during defibrillation.
23. .Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the standard IEC/EN 60601-1-1.
Therefore anybody, who connects additional equipment to the signal 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/EN 60601-1-1. If in
doubt, consult our technical service department or your local distributor.
24. All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
25. The summation of leakage current should never exceed leakage current limits while
several other units are used at the same time; otherwise, electric shock may happen.
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SE-3&SE-300 Series Electrocardiograph User Manual Safety Guidance
WARNING
26. The potential equalization conductor can be connected to that of other equipment
when necessary, to make sure that all these devices are connected to the potential
equalization bus bar of the electrical installation.
27. If the wireless AP technology is used, in order to maintain compliance with the FCC
RF exposure guidelines, the wireless AP should be installed and operated with a
minimum distance of 20cm between the radiator and the human body. Use the
supplied antenna only. There should be no shield in or around the room where the
wireless AP is used.
28. Fix attention on the examination to avoid missing important ECG waves.
29. The disposable electrodes can only be used for one time.
30. We recommend that the electrocardiograph should be working on AC power supply
at least 8 hours per month to avoid DATE&TIME missing.
31. Connecting any accessory (such as external printer) or other device (such as the
computer) to this electrocardiograph makes a medical system. In that case,
additional safety measures should be taken during installation of the system, and the
system shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
32. All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
33. SHOCK HAZARD - Don't connect non-medical electrical equipment, which has been
supplied as a part of the system, directly to the wall outlet when the non-medical
equipment is intended to be supplied by a multiple portable socket-outlet with an
isolation transformer.
34. SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.
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SE-3&SE-300 Series Electrocardiograph User Manual Safety Guidance
WARNING
35. Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1 approved to the electrocardiograph.
The operation or use of non-approved equipment or accessories with the
electrocardiograph is not tested or supported, and electrocardiograph operation and
safety are not guaranteed.
36. Do not use the additional multiple portable socket-outlet or extension cord in the
medical electrical system, unless it's specified as part of the system by manufacturer.
And the multiple portable socket-outlets provided with the system shall only be used
for supplying power to equipment which is intended to form part of the system.
37. The electrocardiograph shall not be serviced or maintained while in use with a
patient.
38. The appliance coupler or mains plug is used as isolation means from supply mains.
Position the electrocardiograph in a location where the operator can easily access
the disconnection device.
39. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC Information.
40. The equipment should not be used adjacent to or stacked with other equipment, refer
to the recommended separation distances provided in Appendix 2 EMC Information.
41. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information.
42. Assembly of the electrocardiograph and modifications during actual service life shall
be evaluated based on the requirements of IEC60601-1.
1.2.2 Lithium Battery Care Warnings
WARNING
1. Improper operation may cause the lithium battery (hereinafter called battery) to be
hot, ignited or exploded, and it may lead to the declination of the battery capacity. It is
necessary to read the user manual carefully and pay more attention to warning
messages.
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SE-3&SE-300 Series Electrocardiograph User Manual Safety Guidance
WARNING
2. Only qualified service engineer authorized by the manufacturer can open the battery
compartment and replace the battery, and batteries of the same model and
specification as manufacturer configuration should be used.
3. Danger of explosion -- Do not reverse the anode and the cathode when installing the
battery.
4. Do not heat or splash the battery or throw it into fire or water.
5. When leakage or foul smell is 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.
6. The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of
them together with house-hold garbage. At the end of their lives hand the batteries
over to the applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or the battery, please contact your
local Civic Office, or the shop where you purchased the product.
7. Remove the battery from the electrocardiograph when the electrocardiograph is not
used for a long time.
8. If the battery is stored alone and not used for a long time, we recommend that the
battery should be charged at least once every 6 months to prevent over-discharge.
1.2.3 General Cautions
CAUTION
1. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
2. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.
3. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
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SE-3&SE-300 Series Electrocardiograph User Manual Safety Guidance
CAUTION
4. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters, mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment is likely to bring electromagnetic
interference.
5. Before use, the equipment, the 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 the performance.
6. Ruptured fuse must only be replaced with that of the same type and rating as the
original.
1.2.4 Cleaning & Disinfection Cautions
CAUTION
1. Turn off the power before cleaning and disinfection. If the mains supply is used, the
power cord should be dragged out of the outlet. Prevent the detergent from seeping
into the equipment during cleaning.
2. Do not immerse the unit or the patient cable into liquid under any circumstances.
3. Do not clean the unit and accessories with abrasive fabric and avoid scratching the
electrodes.
4. Any remainder of detergent should be removed from the unit and the patient cable
after cleaning.
5. Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.
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SE-3&SE-300 Series Electrocardiograph User Manual Safety Guidance
No.
Symbol
Description
1
Output
2
Input
3
DEFIBRILLATION-PROOF TYPE CF
APPLIED PART
4
Attention, consult ACCOMPANYING
DOCUMENTS
5
Operating instructions
6
Equipotential grounding
7
Alternating Current
8
"ON" (power)
9
"OFF" (power)
10
Battery check
11
Battery recharging indicator
12
SE-3 SE-300 series
ON/OFF key
1.3 List of Symbols
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SE-3&SE-300 Series Electrocardiograph User Manual Safety Guidance
13
Print/Stop key
14
General symbol for recovery/recyclable
15
Part Number
16
SERIAL NUMBER
17
Date of manufacture
18
MANUFACTURER
19
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
20
CE marking
21
Disposal method
22
Caution: Federal (U.S.) law restricts this device to
sale by or on the order of a physician
23
Refer to User Manual
(Background: Blue; Symbol: White)
NOTE: The user manual is printed in black and white.
- 9 -
SE-3&SE-300 Series Electrocardiograph User Manual Introduction
Chapter 2 Introduction
SE-300 series electrocardiograph has two models: SE-300A and SE-300B.
SE-3/SE-300 series 3-channel electrocardiograph gathers ECG signals of 12 leads simultaneously.
It displays the operation menu, ECG parameters as well as electrocardiograms.
3-channel ECG waves can be viewed on the LCD screen and printed out by using a high-quality
thermal recorder. The screen of SE-3 configuration A and SE-300A is black and white screen, and
the screen of SE-3 configuration B and SE-300B is color screen.
The AUTO, MANU, OFF-AUTO, RHYT, OFF- RHYT and R-R modes can be chosen freely.
SE-3/SE-300 series can be powered by the mains supply or a built-in rechargeable lithium battery.
Basic type and Net type are optional for each model, only the Net type electrocardiograph can
support network transmission function. The DE12 ECG board is optional for all the models. With
the DE12 ECG board, SE-3/SE-300 series can support full-scale pacemaker detection function.
With a high resolution thermal recorder, a 32-bit processor and a large-capacity memorizer,
SE-3/SE-300 series has advanced performance and high reliability. The compact size makes it
suitable for clinic, hospital and ambulance use.
Configuration: main unit, power cord, earth wire, patient cable, electrodes, thermal recorder
paper, fuses and lithium battery
2.1 Top Panel
Figure 2-1 SE-3
- 10 -
SE-3&SE-300 Series Electrocardiograph User Manual Introduction
Figure 2-2 SE-300 series
2.2 Control Panel and Keys
Figure 2-3 SE-3 Control Panel and Keys
- 11 -
SE-3&SE-300 Series Electrocardiograph User Manual Introduction
Mains supply indicator lamp: when the device is powered by the mains supply,
the lamp will be lit.
Battery indicator lamp: when the device is powered by a built-in rechargeable
lithium battery, the lamp will be lit.
Battery recharging indicator lamp: when the battery is being recharged, this lamp
will be lit.
Press the RECALL key to open the File Manager screen. For details, see chapter 7,
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SE-3&SE-300 Series Electrocardiograph User Manual Introduction
Mode
Switch Order (from Left to Right)
AUTO(Standard)
І/II/III
aVR/aVL/aVF
V1/V2/V3
V4/V5/V6
AUTO(Cabrera)
aVL/ I /-aVR
II /aVF/ III
V1/V2/V3
V4/V5/V6
MANUAL
In this mode, you need to press the Lead switch key to change the
lead groups, the lead switch order can be that of AUTO (Standard)
or AUTO (Cabrera), which is determined by settings of lead
sequence and printing format on the System Setup Screen.
“Managing ECG Records”.
4) 1mV/COPY Key
(SE-3) (SE-300 series)
In the Manual mode, press this key to print a 1mV calibration mark while printing ECG
reports.
In the AUTO or RHYT mode, press this key to copy and print the recent report.
5) MODE/RST Key
(SE-3) (SE-300 series)
Press this key to select a printing mode among AUTO, MANU, OFF-AUTO, RHYT, OFF- RHYT and R-R.
The switch order of lead groups in each mode is listed in Table 2-1.
In the MANUAL mode, press this key to reset the waveform quickly while printing ECG
reports.
WARNING
When using the device with a defibrillator, after the defibrillator discharges, you should
press the MODE/RST key to reset the waveform quickly.
NOTE: The detailed information of the automatic mode can be set on the System Setup
Screen.
Table 2–1 Switch Order of Lead Groups in Different Modes
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SE-3&SE-300 Series Electrocardiograph User Manual Introduction
6) LEAD Switch Key
(SE-3) (SE-300 series)
In the MANU mode, press these two keys to switch the lead groups.
In System SetupRecord Info window, press these two keys to switch Setup 1 and Setup
2.
On the File Manager screen, press these two keys to go to the prev or next page of
records.
7) PRINT/STOP Key
Press this key to begin or stop printing ECG reports.
8) ON/OFF Key
(SE-3) (SE-300 series)
Press this key to turn on or off the device.
9) MENU Key
(SE-3) (SE-300 series)
Press this key to open the System Setup Screen.
10) Up Arrow/Down Arrow Key
(SE-3) (SE-300 series)
Press the Up or Down arrow to select an item on the Main Screen and the System Setup
Screen.
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SE-3&SE-300 Series Electrocardiograph User Manual Introduction
Net Port
Patient Cable Socket
RS232 Socket
External Input/Output Socket
USB Interface
11) Left Arrow/ Right Arrow Key
(SE-3) (SE-300 series)
Press the Left or Right arrow to set the selected item.
2.3 Patient Cable Socket and Signal Interface
As shown in Figure 2-1 and Figure 2-5, on the right side of the main unit are the patient cable
socket, the RS232 socket, the external input/output socket and the USB interface.
Figure 2-5 SE-300 series
The net port (optional, only for Net type) is on the back of the main unit shown in the following
figure. Only the electrocardiograph with net port can support network transmission function.
Figure 2-6 SE-3
WARNING
1. Only the USB equipment recommended by the manufacturer can be connected to the
USB interface.
2. The summation of leakage current should never exceed the leakage current limit
while several other units are used at the same time.
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SE-3&SE-300 Series Electrocardiograph User Manual Introduction
Mains Supply Shift
Switch
Fuse Label
Battery Compartment
Label
Fuse
Mains Switch
Potential Equalization
Terminal
Mains Socket
2.4 Mains Connection and Switch
2.5 Bottom Panel
1)Mains Supply Shift Switch
Mains supply with rated input voltage 230V (220-240V) or 115V (100-115V) can be chosen
by using the shift switch according to local mains supply specifications.
WARNING
Only qualified installation or service engineer can shift the mains supply shift switch
according to local mains supply specifications.
2) Fuse
There are two fuses of the same specifications installed on the bottom of the main unit.
WARNING
Ruptured fuses must only be replaced with those of the same type and rating as the
original.
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SE-3&SE-300 Series Electrocardiograph User Manual Introduction
2.6 Features
♦ Low weight and compact size
♦ High resolution thermal recorder, recording frequency response ≤150Hz
♦ ECG signals of 12 leads are gathered and amplified simultaneously, 3-channel waves
are displayed and recorded simultaneously
♦ Offer AUTO, MANU, OFF-AUTO, RHYT, OFF- RHYT and R-R modes
♦ Measurement function and interpretation function are optional
♦ System Setup Screen for parameter settings
♦ Built-in rechargeable lithium battery with large capacity
♦ Hint information for lead off, lack of paper, low battery capacity etc.
♦ Automatic adjustment of baseline for optimal printing
♦ Standard input/output interface and RS232 communication interface
♦ ECG data can be transmitted to the PC software through the serial cable, net cable
(optional, only for net type), or wireless AP (optional).
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SE-3&SE-300 Series Electrocardiograph User Manual About the Application Interface
Name
Explanation
A
Patient Symbol
Select the symbol and press the left or right arrow to open Patient
Information window
B
ID
Patient ID
C
Gender
Patient Gender, press the left and right arrows to switch male and
female
D
Age
Input Patient age or choose the age group
E
Work Mode
Include: AUTO, MANU, OFF-AUTO, RHYT, OFF-RHYT and R-R
F
HR
The actual HR value
G
Current Time
Show the current time
Chapter 3 About the Application Interface
The following sections provide an overview of the main functions in the SE-3/SE-300 series
application. When switched on, the Main Screen pops up. Then you can press the MENU key to
open the System Setup Screen. Or press the RECALL key to open the File Manager screen.
3.1 About the Main Screen
On the main screen, press the up and down arrows to move the cursor to the items that need to be
modified, and press the left and right arrows to modify the value.
The Main Screen includes:
Figure 3-1 Main Screen
- 18 -
SE-3&SE-300 Series Electrocardiograph User Manual About the Application Interface
H
Battery Symbol
Identify the current capacity of the battery
I
Waveform zone
Show waveform
J
Hint
Information
Including No Paper, Paper Error, Sampling, Analyzing,
Recording, Transmitting, Memory Full, U Disk, USB Printer,
Lead Off, Scanner, Reader. For details, please refer to Chapter 10
"Hint Information".
K
Lead Name
Including DEMO, Module Error, Overload, Lead Name (When the
leads are off, the lead names will be highlighted. For details, please
refer to Chapter 10 "Hint Information".
L
25mm/s
Speed
M
10mm/mV
Sensitivity
N
100Hz
Filter
NOTE: The speed, sensitivity or filter value modified in the main screen is only valid for
the current exam.
3.2 About the System Setup Screen
Figure 3-2 System Setup Screen
Press MENU on the main screen to display the System Setup screen.
On the System Setup screen, move the cursor on an item, and then press MENU to open the
setup window of the item. And press Return or RECALL to exit the System Setup screen.
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SE-3&SE-300 Series Electrocardiograph User Manual About the Application Interface
3.3 About the File Manager screen
Figure 3-3 File Manager screen (a)
Press the Up or Down arrow to select the patient record, press Lead() or Lead () to switch
the prev or next page.
Press the Left or Right arrow to move the cursor among TransALL, ExportALL, Del All, Select,
Search, Import and Return buttons and then press the MENU key to conform the operation.
Press RECALL again to return to the main screen.
Press the Left or Right arrow to move the cursor to Select button and press MENU key to enter
File Manager screen (b).
Figure 3-4 File Manager screen (b)
Press the Left or Right arrow to move the cursor among Edit, Trans, Export, Delete and Return
buttons and then press the MENU key to conform the operation.
Press RECALL to return to the previous screen.
For details on managing patient records, please refer to chapter 7, “Managing ECG Records”.
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