EDAN SE-601 Series User manual

I
About this Manual
P/N: 01.54.110286
MPN: 01.54.110286023
Release Date: December 2018
© Copyright EDAN INSTRUMENTS, INC. 2008-2018. 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-601A, SE-601B, SE-601C

II
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
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.

III
Table of Contents
Chapter 1 Safety Guidance ...........................................................................................................1
1.1 Intended Use/Indications for Use...........................................................................................1
1.2 Warnings and Cautions...........................................................................................................1
1.2.1 Safety Warnings ...............................................................................................................2
1.2.2 Li-ion Battery Care Warnings ..........................................................................................5
1.2.3 General Cautions..............................................................................................................6
1.3 List of Symbols.......................................................................................................................7
Chapter 2 Introduction................................................................................................................ 11
2.1 Top Panel .............................................................................................................................. 11
2.2 Keyboard and Keys ..............................................................................................................12
2.3 Rear Panel.............................................................................................................................14
2.4 Right Panel ...........................................................................................................................14
2.5 Bottom Panel ........................................................................................................................15
2.6 Features.................................................................................................................................16
Chapter 3 Operation Preparations.............................................................................................18
3.1 Connecting the Patient Cable to the Electrocardiograph and Electrodes.............................18
3.1.1 Connecting the Patient Cable to the Electrocardiograph ...............................................18
3.1.2 Connecting the Patient Cable to Electrodes...................................................................19
3.2 Preparing the Patient.............................................................................................................19
3.2.1 Instructing the Patient ....................................................................................................19
3.2.2 Cleaning the Skin...........................................................................................................20
3.3 Attaching Electrodes to the Patient.......................................................................................20
3.3.1 Electrode Placement.......................................................................................................21
3.3.2 Attaching the Reusable Electrodes.................................................................................22
3.3.3 Attaching the Disposable Electrodes..............................................................................23
3.4 Inspection Before Power-On ................................................................................................24
3.5 Turning On/Off the Electrocardiograph................................................................................25
3.6 Loading/Replacing Recorder Paper......................................................................................26
Chapter 4 Basic Operation Guidance ........................................................................................29
4.1 Basic Operation.....................................................................................................................29
4.2 About the Main Screen .........................................................................................................30
4.3 Work Mode Description .......................................................................................................31
Chapter 5 Entering Patient Information ...................................................................................32
5.1 Entering Patient Information Manually................................................................................32
5.2 Entering Patient Information by Using a Reader (Configurable).........................................32

IV
5.3 Entering Patient Information byAcquiring Orders ..............................................................32
Chapter 6 Printing ECG Reports ...............................................................................................33
Chapter 7 Transmitting ECG Data.............................................................................................34
7.1 Transmitting ECG Data in DAT Format Through Serial Cable ...........................................35
7.2 Transmitting ECG Data Through Network ..........................................................................35
7.2.1 Transmitting ECG Data in DAT Format ........................................................................35
7.2.2 Transmitting ECG Data in SCP/FDA-XML/PDF/DICOM Format...............................36
Chapter 8 Managing Orders.......................................................................................................37
Chapter 9 Managing Files...........................................................................................................39
Chapter 10 System Setup.............................................................................................................42
10.1 Work Mode Setup...............................................................................................................42
10.2 Filter Setup .........................................................................................................................42
10.3 Record Info Setup...............................................................................................................43
10.3.1 Setup 1..........................................................................................................................43
10.3.2 Setup 2..........................................................................................................................44
10.4 Patient Information Setup...................................................................................................45
10.5 Transmission Setup.............................................................................................................46
10.5.1 Basic Setup...................................................................................................................46
10.5.2 WIFI Setup (Configurable)* ........................................................................................47
10.6 Lead Setup..........................................................................................................................47
10.7 Display&Sound Setup ........................................................................................................48
10.8 Date&Time Setup...............................................................................................................48
10.9 File Setup............................................................................................................................49
10.10 System Maintenance Setup...............................................................................................49
10.11 Other Setup.......................................................................................................................50
Chapter 11 Error Messages.........................................................................................................51
Chapter 12 FAQ ...........................................................................................................................52
Chapter 13 Cleaning, Care and Maintenance ...........................................................................56
13.1 General Points.....................................................................................................................56
13.2 Cleaning..............................................................................................................................56
13.3 Disinfection ........................................................................................................................57
13.4 Care and Maintenance........................................................................................................58
13.4.1 Recharge and Replacement of Battery.........................................................................58
13.4.2 Recorder Paper.............................................................................................................60
13.4.3 Visual inspection..........................................................................................................61

V
13.4.4 Maintenance of the Main Unit and the Patient Cable..................................................61
Chapter 14 Accessories ................................................................................................................64
14.1 Standard Accessories..........................................................................................................64
14.2 Optional Accessories ..........................................................................................................64
Chapter 15 Warranty & Service.................................................................................................66
15.1 Warranty .............................................................................................................................66
15.2 Contact information............................................................................................................66
Appendix 1 Technical Specifications..........................................................................................67
A1.1 Safety Specifications .........................................................................................................67
A1.2 Environment Specifications...............................................................................................68
A1.3 Physical Specifications......................................................................................................68
A1.4 Power Supply Specifications.............................................................................................68
A1.5 Performance Specifications...............................................................................................69
Appendix 2 EMC Information....................................................................................................72
Appendix 3 Abbreviation.............................................................................................................79

SE-601 Series Electrocardiograph User Manual Safety Guidance
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Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of SE-601 series
electrocardiograph.
1.1 Intended Use/Indications for Use
The intended use of SE-601 series electrocardiograph (hereinafter called SE-601 series) is to
acquire resting ECG signals from adult and pediatric patients through body surface ECG
electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities
by doctors and trained healthcare professionals. The cardiogram recorded by the
electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted
ECG with measurements and interpretive statements is offered to clinicians on an advisory basis
only.
SE-601 series is mainly used in ECG outpatient department, PE department, emergency
department and inpatient department of hospitals or healthcare facilities.
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 operation, 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.

SE-601 Series Electrocardiograph User Manual Safety Guidance
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1.2.1 Safety Warnings
WARNING
1. The electrocardiograph is intended to be used by 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. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of
flammable anesthetic mixtures with oxygen or other flammable agents.
4. 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.
5. Make sure that the power is turned off and the power cord is disconnected from the
AC socket before connecting or disconnecting equipment. Otherwise, electrical
shock or other injuries may happen to the patient or operator.
6. If the integrity of the external protective conductor is in doubt, the equipment should
be powered by an internal li-ion rechargeable battery.
7. Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.
8. 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.
9. The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
10. Make sure that all electrodes are connected to the patient correctly before operation.
11. Ensure that the conductive parts of electrodes and associated connectors, including
neutral electrodes, do not come in contact with earth or any other conducting objects.

SE-601 Series Electrocardiograph User Manual Safety Guidance
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WARNING
12. Disposable electrodes must be used during defibrillation.
13. Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.
14. The disposable electrodes can only be used for one time.
15. Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.
16. Do not touch accessible parts of electrical equipment and the patient simultaneously.
17. 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.
18. If WIFI technology is used, in order to maintain compliance with the FCC RF
exposure guidelines, WIFI should be installed and operated with a minimum distance
of 20cm between the radiator and the human body. There should be no shield in or
around the room where WIFI is used.
19. Fix attention on the examination to avoid missing important ECG waves.
20. 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.
21. 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.
22. 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.

SE-601 Series Electrocardiograph User Manual Safety Guidance
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WARNING
23. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
24. Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
25. Multiple portable socket-outlets shall not be placed on the floor.
26. 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.
27. 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
configuration shall comply with the valid version of the standard IEC/EN 60601-1.
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. If in doubt,
consult our technical service department or your local distributor.
28. 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.
29. 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.
30. 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.

SE-601 Series Electrocardiograph User Manual Safety Guidance
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WARNING
31. The potential equalization bar can be connected to that of other equipment when
necessary. Make sure that all the equipment is connected to the potential
equalization terminal.
32. The electrocardiograph shall not be serviced or maintained while in use with a
patient.
33. 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.
34. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC Information.
35. 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.
36. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information.
37. Assembly of the electrocardiograph and modifications during actual service life shall
be evaluated based on the requirements of IEC60601-1.
1.2.2 Li-ion Battery Care Warnings
WARNING
1. Improper operation may cause the internal li-ion battery (hereinafter called battery) to
be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It
is necessary to read the user manual carefully and pay more attention to warning
messages.
2. Only qualified service engineers 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.

SE-601 Series Electrocardiograph User Manual Safety Guidance
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WARNING
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 isn't
used for a long time.
10. If the battery is stored alone and not used for a long time, we recommend that the
battery be charged at least once every 6 months to prevent overdischarge.
1.2.3 General Cautions
CAUTION
1. 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.
2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
3. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.
4. Ruptured fuse must only be replaced with that of the same type and rating as the
original.

SE-601 Series Electrocardiograph User Manual Safety Guidance
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CAUTION
5. 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.
6. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
1.3 List of Symbols
No.
Symbol
Description
1
External input/output
2
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
3
Caution
4
Operating instructions
5
Equipotential grounding
6
Patient Cable Socket
7
USB socket

SE-601 Series Electrocardiograph User Manual Safety Guidance
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8
Net port
9
Alternating Current
10
Battery check
11
Battery recharging indicator
12
Delete key
13
Enter key
14
Esc key
15
Space key/Feed paper key
16
Shift key
17
Fn key
18
Power On/Off key
19
1mV/COPY key
20
MODE key
21
RESET key

SE-601 Series Electrocardiograph User Manual Safety Guidance
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22
PRINT/STOP key
23
Tab paper key
24
Gender key
25
Age Group key
26
General symbol for recovery/recyclable
27
Part Number
28
SERIAL NUMBER
29
Date of manufacture
30
MANUFACTURER
31
AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY
32
CE marking
33
Caution: Federal (U.S.) law restricts this device to sale by
or on the order of a physician.
34
Disposal method
35
Refer to User Manual
(Background: Blue; Symbol: White)

SE-601 Series Electrocardiograph User Manual Safety Guidance
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36
Warning
(Background: Yellow; Symbol&Outline: Black)
37*
Non- ionizing electromagnetic radiation
38*
Contains FCC ID:
YOPGS2011MIZ
Federal Communications Commission:
Contains FCC ID: YOPGS2011MIZ
39
Conforms toAAMI Std. 60601-1, IEC Std. 60601-2-25
Certified to CSAStd. C22.2 No 60601-1,CSAStd. C22.2
No 60601-2-25
NOTE:
1. 37*/38*: Apply to devices with wireless functions.
2. The user manual is printed in black and white.

SE-601 Series Electrocardiograph User Manual Introduction
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Chapter 2 Introduction
SE-601 series electrocardiograph has three models: SE-601A, SE-601B and SE-601C.
SE-601A adopts 3.5" single color LCD screen; SE-601B adopts 5.6"/5.7" multicolor TFT LCD
screen; SE-601C adopts 5.6"/5.7" multicolor TFT LCD touch screen.
Configuration: main unit, power cord, patient cable, chest electrodes, limb electrodes,
disposable electrodes, clip/snap/banana socket adaptors, thermal recorder paper,
fuses and battery.
NOTE: The pictures and windows in this manual are for reference only.
2.1 Top Panel
Figure 2-2 Top panel (SE-601B/C)
Recorder
LCD Screen
Keyboard
Indicators

SE-601 Series Electrocardiograph User Manual Introduction
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2.2 Keyboard and Keys
Figure 2-3 Keyboard
Name
Explanation
A
Indicator
It indicates the working state.
B
Function Key
Press to select menu functions on the screen.
Press F1,F2, F3, F4 to move the cursor.
Press Shift + F1/F2 to turn pages on the Order Manager screen and the
File Manager screen.
Press Shift + F3/F4 to slide the scroll bar on the Order Manager screen.
C
Gender Key
Press to quickly select the gender for the patient when Gender is
selected in the Patient Information Setup window.
D
Age Group Key
Press to quickly select the age group on the main screen when you set
Age to Age Group in the Patient Information Setup window.
E
Backspace Key
Press to delete characters.
F
Enter
Press to confirm operation.
G
Shift
Press Shift + Tab to move the cursor backward.
Press Shift and a number key to input the special character in the top
right corner of the key.
If Caps Lock is set to Off, pressing Shift + Pcan type a capital P.
If Caps Lock is set to On, pressing Shift + Pcan type a lowercase p.
H
Fn
Press Fn and a letter key to type special characters.
Pressing Fn + acan type è.
B
E
F
L
K
J
G
I
N
O
M
P
H
A
C
D

SE-601 Series Electrocardiograph User Manual Introduction
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I
PRINT/STOP
Press to start or stop printing reports
Pressing Shift +PRINT/STOP can quickly enable or disable the print out
function in the auto or rhythm mode.
J
1mV/COPY
In the manual mode, pressing the 1mV/COPY key can insert a 1mV
calibration mark during the printing course.
In the auto or rhythm mode, pressing the 1mV/COPY key can print the
ECG report which was printed out last time.
K
RESET
A large polarization voltage may cause baseline drift. On the main
screen, pressing RESET can decrease the polarization voltage and draw
the baseline to zero quickly.
L
MODE
Press to select a working mode among the auto, manual, rhythm and
R-R analysis modes.
NOTE: Only if more than one working mode is selected in the Work
Mode Setup window, can the working mode be selected by
pressing the MODE key when the main screen is displayed.
M
Space/Feed
paper
Press to add a space between typed characters or select/deselect a
checkbox.
Press to feed paper:
If Paper Marker is set to Yes, pressing Tab can advance the recorder
paper to the next black marker; if Paper Marker is set to No, pressing
Tab can advance the paper for 2.5cm. Pressing Tab again can stop
advancing the paper.
N
Tab
Press to move the cursor:
Pressing Tab can move the cursor forward, and pressing Shift + Tab can
move the cursor backward.
In the manual mode or on the previewing screen, press this key to switch
the lead groups.
O
Esc
Press to cancel operation
P
Power On/Off
Power-on/Power-off

SE-601 Series Electrocardiograph User Manual Introduction
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2.3 Rear Panel
Figure 2-4 SE-601A/B/C Rear Panel
2.4 Right Panel
Figure 2-5 SE-601A/B/C Right Panel
Name
Explanation
A
Patient Cable Socket
Connecting to the patient cable
B
Serial Port 1
Connecting to a PC
C
USB Socket 1
Standard USB socket, connecting to a PC
D
USB Socket 2
Standard USB socket, connecting to a U disk, a
bar code reader or a USB printer recommended by
the manufacturer
E
Net port
Standard net port, connecting to a PC
Potential Equalization Conductor
Mains Supply Socket
Handle
USB Socket 2
Patient Cable Socket
External Input / Output Socket
USB Socket 1
Serial Port 1
Net port