EDAN INSTRUMENTS SE301EDAN User Manual
About this Manual
P/N: 01.54.456718
MPN: 01.54.456718011
Release Date: July, 2015
© Copyright EDAN INSTRUMENTS, INC. 2015. All rights reserved.
Statement
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.
Product Information
Product Name: Electrocardiograph
Model: SE-301, iSE-301
Responsibility of the Manufacturer
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.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.
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.
II
Table of Contents
Chapter 1 Safety Guidance ....................................................................................................... 1
1.1 Indications for Use/Intended Use ..................................................................................... 1
1.2 Warnings and Cautions ..................................................................................................... 1
1.2.1 Safety Warnings ........................................................................................................ 2
1.2.2 Lithium Battery Care Warnings ................................................................................ 5
1.2.3 General Cautions ...................................................................................................... 6
1.3 List of Symbols ................................................................................................................. 7
Chapter 2 Introduction ............................................................................................................ 10
2.1 Top Panel ........................................................................................................................ 10
2.2 Bottom Panel ................................................................................................................... 11
2.3 Right Panel ...................................................................................................................... 11
2.4 Back Panel ...................................................................................................................... 11
Chapter 3 Operation Preparations ......................................................................................... 12
3.1 Loading/Replacing Recorder Paper ................................................................................ 12
3.2 Preparing the Patient ....................................................................................................... 13
3.2.1 Instructing the Patient ............................................................................................. 13
3.2.2 Cleaning the Skin .................................................................................................... 13
3.3 Connecting the Patient Cable to the Electrocardiograph and Electrodes ....................... 13
3.4 Attaching Electrodes to the Patient ................................................................................. 14
3.4.1 Reusable Electrodes ................................................................................................ 14
3.4.2 Disposable Electrodes ............................................................................................. 17
3.5 Inspection Before Power On ........................................................................................... 18
Chapter 4 Sampling and Printing ECG ................................................................................. 20
4.1 Entering Patient Information .......................................................................................... 20
4.1.1 Entering Patient Information Manually .................................................................. 20
4.1.2 Entering Patient Information by Acquiring Orders ................................................ 21
4.2 Printing ECG Reports ..................................................................................................... 21
4.3 Sample ECG Reports ...................................................................................................... 22
4.3.1 ECG Reports in the AUTO Mode ........................................................................... 22
4.3.2 PDF Report ............................................................................................................. 24
Chapter 5 Managing ECG Records ........................................................................................ 25
5.1 Transmitting ECG Records to the PC ............................................................................. 25
5.1.1 Transmitting ECG Records through the Network .................................................. 25
5.1.2 Transmitting ECG Records through WIFI Network (Optional) ............................. 26
5.2 Copying ECG Records between the ECG Machine and External Memory ................... 26
5.3 Deleting Patient Records ................................................................................................ 28
5.4 Printing a Patient Record in the File Manager screen..................................................... 28
III
Chapter 6 Settings .................................................................................................................... 29
6.1 Work Mode ..................................................................................................................... 29
6.2 Filter ................................................................................................................................ 29
6.3 Record Info Setup ........................................................................................................... 30
6.3.1 Setup 1 .................................................................................................................... 30
6.3.2 Setup 2 .................................................................................................................... 31
CAUTION ................................................................................................................................. 32
6.4 Patient Information Setup ............................................................................................... 33
6.5 Transmission Setup ......................................................................................................... 34
6.6 Lead Setup ...................................................................................................................... 34
6.7 File Setup ........................................................................................................................ 35
6.8 Date&Time Setup ........................................................................................................... 36
6.9 System Maintenance ....................................................................................................... 36
6.10 Other Setup ................................................................................................................... 36
6.11 Advanced Setup ............................................................................................................. 37
Chapter 7 Hint Information .................................................................................................... 38
Chapter 8 Troubleshooting ...................................................................................................... 39
Chapter 9 Cleaning, Care and Maintenance ......................................................................... 41
9.1 General Points ................................................................................................................. 41
9.2 Cleaning .......................................................................................................................... 41
9.2.1 Cleaning the Main Unit .......................................................................................... 42
9.2.2 Cleaning the Patient Cable ..................................................................................... 42
9.2.3 Cleaning the Reusable Electrodes .......................................................................... 43
9.3 Disinfection ..................................................................................................................... 43
9.3.1 Disinfecting the Main Unit ..................................................................................... 43
9.3.2 Disinfecting the Patient Cable ................................................................................ 44
9.3.3 Disinfecting the Reusable Electrodes ..................................................................... 44
9.4 Care and Maintenance .................................................................................................... 44
9.4.1 Recharge and Replacement of Battery ................................................................... 44
9.4.2 Recorder Paper ....................................................................................................... 45
9.4.3 Maintenance of the Main Unit, the Patient Cable and Electrodes .......................... 46
Chapter 10 Accessories ............................................................................................................ 48
Chapter 11 Warranty and Service .......................................................................................... 50
11.1 Warranty ........................................................................................................................ 50
11.2 Contact information ...................................................................................................... 50
Appendix 1 Technical Specifications ...................................................................................... 51
A1.1 Safety Specifications .................................................................................................... 51
A1.2 Environment Specifications ......................................................................................... 52
IV
A1.3 Physical Specifications ................................................................................................ 52
A1.4 Power Supply Specifications ....................................................................................... 52
A1.5 Performance Specifications ......................................................................................... 53
Appendix 2 EMC Information ................................................................................................ 55
Appendix 3 Abbreviation ......................................................................................................... 59
V
SE-301 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 Indications for Use/Intended Use
The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and
pediatric patients 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-301 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-240V~) according to local mains supply specifications.
4. The EQUIPMENT is protected against malfunction caused by electrosurgery.
5. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of
flammable anesthetic mixture with oxygen or other flammable agents.
6. 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.
7. If the integrity of the external protective conductor is in doubt, the equipment should
be operated by using the built-in rechargeable battery.
8. Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.
9. 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.
10. The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
11. 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.
12. Make sure that all electrodes are connected to the patient correctly before operation.
13. 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.
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SE-301 Series Electrocardiograph User Manual Safety Guidance
WARNING
14. 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.
15. 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.
16. If reusable electrodes with electrode gel are used during defibrillation, ECG recovery
will take more than 10 seconds. The manufacturer recommends the use of
disposable electrodes at all times.
17. Electrodes of dissimilar metals should not be used; it may cause a high polarization
voltage.
18. The disposable electrodes can only be used for one time.
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. The use of equipment that applies high frequency voltages to the patient (including
electrosurgical equipment and some respiration transducers) is not supported and
may produce undesired results. Disconnect the patient data cable from the
electrocardiograph, or detach the leads from the patient prior to performing any
procedure that uses high frequency surgical equipment.
22. If WIFI technology is used, in order to maintain compliance with the FCC RF
exposure guidelines, the wireless 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 WIFI is used.
23. Fix attention on the examination to avoid missing important ECG waves.
24. 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.
25. 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-301 Series Electrocardiograph User Manual Safety Guidance
WARNING
26. 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.
27. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
28. Multiple portable socket-outlets shall not be placed on the floor.
29. 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.
30. 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.
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.
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SE-301 Series Electrocardiograph User Manual Safety Guidance
WARNING
33. If multiple instruments are connected to a patient, the sum of the leakage currents
may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
Consult your service personnel.
34. 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.
35. The electrocardiograph shall not be serviced or maintained while in use with a
patient.
36. 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.
37. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC Information.
38. 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.
39. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information.
40. 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.
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.
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SE-301 Series Electrocardiograph User Manual Safety Guidance
WARNING
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. Do not destroy the battery; Do not pierce battery with a sharp object such as a needle;
Do not hit with a hammer, step on or throw or drop to cause strong shock; Do not
disassemble or modify the battery.
6. 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.
7. Properly dispose of or recycle the depleted battery according to local regulations.
8. Only when the device is off can the battery be installed or removed.
9. Remove the battery from the electrocardiograph when the electrocardiograph is not
used for a long time.
10. 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.
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.
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SE-301 Series Electrocardiograph User Manual Safety Guidance
CAUTION
5. Ruptured fuse must only be replaced with that of the same type and rating as the
original.
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 battery, please contact your
local Civic Office, or the shop where you purchased the product.
7. Before use, the equipment, the patient cable and electrodes should be checked.
Replace them if there is any evident defectiveness or aging which may impair the
safety or the performance. Make sure that the equipment is in proper working
condition.
1.3 List of Symbols
No. Symbol Description
1
2
3
4
DEFIBRILLATION-PROOF TYPE CF
APPLIED PART
Caution
Operating instructions
Equipotential grounding
5
6
Power key
Print/Stop key
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SE-301 Series Electrocardiograph User Manual Safety Guidance
7
8
9
10
11
12
13
Casing Button
General symbol for recovery/recyclable
Part Number
SERIAL NUMBER
Date of manufacture
MANUFACTURER
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
14
15
16
17
18
19
20
CE marking
Disposal method
SD card slot
USB socket
Net port
Power adapter port
Caution: Federal (U.S.) law restricts this device
to sale by or on the order of a physician
21
Refer to User Manual
(Background: Blue; Symbol: White)
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SE-301 Series Electrocardiograph User Manual Safety Guidance
Warning
22
(Background: Yellow; Symbol&Outline: Black)
23*
FCC ID: SMQSE301EDAN
SMQSE301EDAN
Federal Communications Commission: FCC ID:
24*
Non- ionizing electromagnetic radiation
NOTE:
1. *Applicable to the Electrocardiograph configured with WIFI module.
2. For details about buttons of the keyboard, refer to Chapter 2.
3. The user manual is printed in black and white.
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SE-301 Series Electrocardiograph User Manual Introduction
Chapter 2 Introduction
SE-301 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 AUTO, MANU, RHYT, and R-R modes can be chosen freely.
SE-301 series can be powered by the mains supply or a built-in rechargeable lithium battery. Two
models are available: SE-301 with WIFI as an optional configuration, and iSE301 with WIFI as a
standard configuration.
With a 32-bit processor and a large-capacity memorizer, SE-301 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, and lithium battery
2.1 Top Panel
Figure 2-1 SE-301
No. Description
A
B
Press to release the recorder casing
Press to start/stop ECG sampling
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SE-301 Series Electrocardiograph User Manual Introduction
2.2 Bottom Panel
The silk screen on the battery compartment indicates the rated voltage.
2.3 Right Panel
.
No. Description
A
B
Patient cable socket
Power key (Long press: switch on/off; short press: sleep mode)
Color when using the mains supply: Green
Color when using built-in battery: Blue
Color when recharging: Orange
2.4 Back Panel
No. Description No. Description
A
B
C
USB socket D Equipotential grounding
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E
SD card slot
Net port
Power adapter port - -
SE-301 Series Electrocardiograph User Manual Operation Preparations
Chapter 3 Operation Preparations
3.1 Loading/Replacing Recorder Paper
NOTE:
1. When the folded thermal paper is used, the paper roller is unnecessary and must be
taken out.
2. The grid side of the paper should face the thermal print head, and the black marker
on the paper should face the black marker detecting area.
Loading/Replacing Process of Rolled Thermal Paper
Loading/Replacing Process of Folded Thermal Paper
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SE-301 Series Electrocardiograph User Manual Operation Preparations
3.2 Preparing the Patient
3.2.1 Instructing the Patient
Before attaching the electrodes, greet the patient and explain the procedure. Explaining the
procedure decreases the patient’s anxiety. Reassure the patient that the procedure is painless.
Privacy is important for relaxation. When possible, prepare the patient in a quiet room or area
where others can’t see the patient. Make sure that the patient is comfortable. The more relaxed
the patient is, the less the ECG will be affected by noise.
3.2.2 Cleaning the Skin
Thorough skin preparation is very important. The skin is a poor conductor of electricity and
frequently creates artifact that distorts the ECG signal. By performing methodical skin
preparation, you can greatly reduce the possibility of the noise caused by muscle tremor and
baseline drift, ensuring high-quality ECG waves. There is natural resistance on the skin surface
due to dry, dead epidermal cells, oils and dirt.
To clean the skin
1. Shave hair from electrode sites, if necessary. Excessive hair prevents a good connection.
2. Wash the area thoroughly with soap and water.
3. Dry the skin with a gauze pad to increase capillary blood flow to the tissues and to remove the
dead, dry skin cells and oils.
3.3 Connecting the Patient Cable to the
Electrocardiograph and Electrodes
WARNING
The performance and electric shock protection can be guaranteed only if original patient
cable and electrodes of the manufacturer are used.
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SE-301 Series Electrocardiograph User Manual Operation Preparations
grap
Screw
Main Cable
Lead Wires
Connecting to
Connecting to
Electrodes
Electrocardio
h
1. Connecting the Patient Cable to the Electrocardiograph
Connect the patient cable to the patient cable socket on the right side of the main unit, and then
secure them with two screws.
2. Connecting the Patient Cable to Electrodes
Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the
corresponding electrodes according to the colors and identifiers. Firmly attach them.
3.4 Attaching Electrodes to the Patient
There are two types of electrode for you to choose, one is the reusable electrodes, and the other is
the disposable electrodes. The uses of the two types of electrode are as shown below:
3.4.1 Reusable Electrodes
Reusable Electrodes is divided into Limb electrode and Chest Electrode, as the following figure
shows:
Suction Bulb
Metal Cup
Electrode
Chest Electrode
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