EDAN SE-1515 User manual

I
About this Manual
P/N: 01.54.455911
MPN: 01.54.455911018
Release Date: Oct. 2016
© Copyright EDAN INSTRUMENTS, INC. 2013-2016. 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) cannot 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.
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.

II
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
Contents
Chapter 1 Safety Guidance ...........................................................................................................1
1.1 Indications for Use/Intended Use........................................................................................1
1.2 Warnings and Cautions........................................................................................................1
1.2.1 General Warnings......................................................................................................1
1.2.2 General Cautions.......................................................................................................4
1.2.3 Operation Warnings for Wireless System .................................................................5
1.2.4 Preparation and Operation Warnings (for Exercise ECG) ........................................6
1.2.5 Contraindications (for Exercise ECG)......................................................................7
1.3 List of Symbols...................................................................................................................8
Chapter 2 Introduction................................................................................................................10
2.1 Wired SE-1515 System.....................................................................................................11
2.1.1 Wired System Connection Diagram........................................................................11
2.1.2 Assembling the Wired System ................................................................................12
2.1.3 ECG Sampling Box.................................................................................................13
2.2 Wireless SE-1515 System.................................................................................................14
2.2.1 Wireless System Connection Diagram....................................................................14
2.2.2 Assembling Wireless System ..................................................................................17
2.2.3 ECG Sampling Box.................................................................................................19
2.3 Installing the Software ......................................................................................................21
2.3.1 Requirements of the PC ..........................................................................................21
2.3.2 About Installation Window .....................................................................................22
2.4 Features.............................................................................................................................22
Chapter 3 Preparations Before Operation.................................................................................24
3.1 Preparing the Patient.........................................................................................................24
3.1.1 Instructing the Patient .............................................................................................24
3.1.2 Cleaning the Skin....................................................................................................24
3.2 Connecting the Electrodes of Wired System.....................................................................25
3.3 Connecting the Electrodes of Wireless System.................................................................26
3.4 Attaching Electrodes .........................................................................................................27
3.4.1 Attaching Electrodes for Resting ECG ...................................................................27
3.4.2 Electrode Placement for Exercise ECG ..................................................................32
3.4.3 Attaching the Reusable Electrodes..........................................................................33
3.4.4 Attaching Disposable Electrodes.............................................................................34
3.5 Inspection Before Test.......................................................................................................35
Chapter 4 ECG Sampling............................................................................................................37
4.1 Initial Configuration..........................................................................................................37
4.2 Entering Patient Information.............................................................................................37
4.2.1 Entering Patient Information Manually ..................................................................38

IV
4.2.2 Entering Patient Information by Using a Bar Code Reader....................................39
4.2.3 Retrieve Patient Information...................................................................................39
4.3 Selecting the ECG Sampling Type....................................................................................39
4.4 ECG Sampling ..................................................................................................................40
4.4.1 Resting ECG Sampling...........................................................................................40
4.4.2 STAT ECG...............................................................................................................47
4.4.3 Exercise ECG Sampling..........................................................................................47
4.4.4 VCG Sampling........................................................................................................54
4.4.5 HRV ECG Sampling ...............................................................................................54
Chapter 5 ECGAnalysis..............................................................................................................55
5.1 Resting ECG .....................................................................................................................55
5.1.1 Wave Analysis.........................................................................................................55
5.1.2 Average Template....................................................................................................57
5.1.3 About the Detail Information Window....................................................................57
5.1.4 About the Rhythm Wave Window...........................................................................58
5.1.5 History Record........................................................................................................58
5.1.6 About the Parameters ..............................................................................................58
5.2 Exercise ECG....................................................................................................................59
5.2.1 About the Summary Screen.....................................................................................59
5.2.2 About the All View Screen......................................................................................61
5.2.3 About the ECG Strip Screen ...................................................................................62
5.2.4 STAnalysis .............................................................................................................62
5.2.5 ST Trend..................................................................................................................63
5.3 VCG ..................................................................................................................................63
5.3.1 Displaying Vector ECG with All Plane and All Loop.............................................64
5.3.2 Displaying Vector ECG with Frontal Plane and QRS Loop ...................................66
5.3.3 Displaying 3D Vector ECG.....................................................................................67
5.4 HRV...................................................................................................................................68
5.5 Report Previewing.............................................................................................................69
5.6 Report Printing..................................................................................................................69
5.7 Saving ECG Reports.........................................................................................................69
Chapter 6Archives.......................................................................................................................71
6.1 All List...............................................................................................................................71
6.1.1 Record Display........................................................................................................71
6.1.2 Modifying Patient Information ...............................................................................71
6.1.3 Viewing Examination Records................................................................................72
6.1.4 Deleting Examination Records ...............................................................................72
6.1.5 Merging Examination Records ...............................................................................72
6.1.6 Searching Patient Records.......................................................................................72
6.1.7 Import......................................................................................................................73

V
6.1.8 Export......................................................................................................................73
6.2 Order List..........................................................................................................................74
6.2.1 New Order...............................................................................................................74
6.2.2 Inbox .......................................................................................................................74
6.2.3 Searching Information.............................................................................................74
Chapter 7 Statistics ......................................................................................................................75
Chapter 8 System Setup...............................................................................................................76
8.1 Basic Setup........................................................................................................................76
8.2 Display Setup....................................................................................................................77
8.3 Transmission Setup ...........................................................................................................77
8.4 Output File Setup ..............................................................................................................78
8.5 GDT Setup ........................................................................................................................79
8.6 DICOM Setup ...................................................................................................................79
8.7 HL7 Setup .........................................................................................................................80
8.8 Barcode Setup ...................................................................................................................80
8.9 Other Setup .......................................................................................................................81
8.9.1 Product Authorization .............................................................................................82
8.9.2 Advanced Setting ....................................................................................................82
Chapter 9 Hint Information........................................................................................................84
Chapter 10 Cleaning, Care and Maintenance ...........................................................................85
10.1 General Points.................................................................................................................85
10.2 Cleaning ..........................................................................................................................85
10.2.1 Cleaning the Sampling Box ..................................................................................86
10.2.2 Cleaning the Patient Cable....................................................................................86
10.2.3 Cleaning the Reusable Electrodes (for Resting ECG) ..........................................86
10.3 Disinfection.....................................................................................................................87
10.3.1 Disinfecting the Sampling Box.............................................................................87
10.3.2 Disinfecting the Patient Cable...............................................................................87
10.3.3 Disinfecting the Reusable Electrodes (for Resting ECG).....................................87
10.4 Maintenance of ECG Sampling Box...............................................................................88
Chapter 11 Accessories ................................................................................................................89
Chapter 12 Warranty & Service.................................................................................................93
12.1 Warranty..........................................................................................................................93
12.2 Contact Information........................................................................................................93
Appendix 1 Technical Specifications..........................................................................................94
A1.1 Safety Specifications......................................................................................................94
A1.2 Environment Specifications ...........................................................................................94
A1.3 Physical Specifications...................................................................................................95
A1.4 Power Supply Specifications..........................................................................................95
A1.5 Performance Specifications............................................................................................96

VI
Appendix 2 EMC Information....................................................................................................99
Appendix 3 Abbreviations.........................................................................................................103

SE-1515 PC ECG User Manual Safety Guidance
- 1 -
Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of SE-1515.
1.1 Indications for Use/Intended Use
SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric
patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be
used only in hospitals and healthcare facilities by doctors and trained healthcare professionals.
The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart
diseases. However, the ECG with measurements and interpretive statements is offered to
clinicians on an advisory basis only.
WARNING
1. This system is not designed for intracardiac use or direct cardiac application.
2. This system is not intended for home use.
3. This system is not intended for treatment or monitoring.
4. This system is intended for use on adult and pediatric patients only.
5. The results given by the system should be examined based on the overall clinical
condition of the patient, and they cannot substitute for regular checking.
1.2 Warnings and Cautions
To use the system safely and effectively, firstly be familiar with the operation method of
Windows and read the user manual in detail to be familiar with the proper operation method for
the purpose of avoiding the possibility of system failure. The following warnings and cautions
must be paid more attention to during the operation of the system.
1.2.1 General Warnings
WARNING
1. The system 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.

SE-1515 PC ECG User Manual Safety Guidance
- 2 -
WARNING
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 system 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. Only the patient cable and other accessories supplied by the manufacturer can be
used. Or else, the performance and electric shock protection cannot be guaranteed.
The system has been safety tested with the recommended accessories, peripherals,
and leads, and no hazard is found when the system is operated with cardiac
pacemakers or other stimulators.
6. The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
7. Make sure that all electrodes are connected to the patient correctly before operation.
8. 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.
9. Disposable electrodes must be used during defibrillation.
10.Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.
11.The disposable electrodes can only be used for one time.
12.Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.
13.Do not touch accessible parts of electrical equipment and the patient simultaneously.
14.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 ECG
workstation, or detach the leads from the patient prior to performing any procedure
that uses high frequency surgical equipment.
15.Fix attention on the examination to avoid missing important ECG waves.
16.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.

SE-1515 PC ECG User Manual Safety Guidance
- 3 -
WARNING
17.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.
18.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 system. The operation
or use of non-approved equipment or accessories with the system is not tested or
supported, and system operation and safety are not guaranteed.
19.Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
20.Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
21.Multiple portable socket-outlets shall not be placed on the floor.
22.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.
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.
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.
24.Connecting any accessory (such as external printer) or other device (such as the
computer) to this ECG workstation 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.
25.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.
26.Make sure that there is no intense electromagnetic interference source around when
using the wireless system of SE-1515. Furthermore, keep an unobstructed distance of
at most 5 meters between DX12 transmitter and the PC.

SE-1515 PC ECG User Manual Safety Guidance
- 4 -
WARNING
27.You should purchase computer, printer, treadmill, ergometer, BP monitor and bar code
reader from the manufacturer. Otherwise, the manufacturer will not be held
responsible for the maintenance of the PC hardware, operating system and other
accessories.
28.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.
29.Connecting to other devices may decrease the antistatic gradation of the system
during operation.
30.The system shall not be serviced or maintained while in use with a patient.
31.The appliance coupler or mains plug is used as isolation means from supply mains.
Position the ECG workstation in a location where the operator can easily access the
disconnection device.
32.The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC information.
33.Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information.
34.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.
35.Assembly of the ECG workstation and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
36. The device is MR unsafe. It is not intended for use in an MRI environment.
37. Magnetic and electrical fields are capable of interfering with the proper performance
of the device. For this reason make sure that all external devices operated in the
vicinity of the device comply with the relevant EMC requirements. X-ray equipment or
MRI devices are a possible source of interference as they may emit higher levels of
electromagnetic radiation.
1.2.2 General Cautions
CAUTION
1. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5ºC and 40ºC during operation, and it should be kept between -20ºC and
55ºC during transportation and storage.
2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.

SE-1515 PC ECG User Manual Safety Guidance
- 5 -
CAUTION
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. 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.
5. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
1.2.3 Operation Warnings for Wireless System
WARNING
1. Make sure that there is no intense electromagnetic interference source around the
wireless system.
2. Do not open the battery cover of the transmitter during operation.
3. Improper operations may heat the battery, make it on fire, explode, destroyed or
reduce its capacity. Please read the manual and the cautions carefully before using
the battery.
4. Batteries of the same model and specification as manufacture configuration should be
used.
5. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
6. Do not use the battery near fire or in an environment where the temperature is over
60ºC ; do not heat or splash the battery or throw it into fire or water.
7. 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.
8. 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.

SE-1515 PC ECG User Manual Safety Guidance
- 6 -
WARNING
9. Properly dispose of or recycle the depleted battery according to local regulations.
10.Remove the battery from the transmitter if the system won't be used for a long time.
1.2.4 Preparation and Operation Warnings (for Exercise ECG)
WARNING
1. Test the safety stop (mushroom type) and safety stop (cord type) of the treadmill
before using the system.
2. During the exercise test, ensure that such tests are supervised by properly trained
technician who meets competency requirements for exercise test supervision, fully
trained in cardiopulmonary resuscitation, and is supported by a physician skilled in
exercise testing or emergency medicine who is in close proximity for pretest
assessment or compliance that may raise.
3. Make sure that there is necessary valid first-aid equipment such as defibrillators,
blood-pressure meters etc, and necessary valid medication in the exercise test room.
4. Turn off the system power and disconnect the power cord from the wall outlet after
using the system.
5. Make sure that the power is turned off and the power cord is disconnected from the
AC socket before defibrillation.
6. Keep the four feet of the machine on the ground and make sure that it's stably
working.
7. The treadmill must be powered by the specific power outlet.
8. Examine the treadmill/ergometer carefully before using it.
9. The patient undergoing the exercise test should wear suitable clothes and shoes.
10. Keep hands, hair, jewelry, and loose clothing away from moving parts.
11. Don't let the patient stand on the running belt when starting the treadmill. The patient
should stand on the foot rails and hold the handrails during start-up. Wait until the
running belt is moving before placing feet on the belt.
12. To avoid the static electricity, the patient should not wear loose clothing or clothing
(such as nylon) that easily produces static electricity.
13. Stop exercising immediately when the patient feels uncomfortable or something
abnormal in the operation.
14. Press down the safety stop (mushroom type) or pull out the safety stop (cord type) to
stop the treadmill immediately when an emergency happens.

SE-1515 PC ECG User Manual Safety Guidance
- 7 -
1.2.5 Contraindications (for Exercise ECG)
Absolute Contraindications:
1. Acute MI (within 2 days)
2. High-risk unstable angina
3. Hemodynamic compromise caused by uncontrolled cardiac arrhythmia
4. Symptomatic severe aortic stenosis
5. Heart failure with clinic episode uncontrolled
6. Acute pulmonary embolus or pulmonary infarction
7. Acute myocarditis or pericarditis
8. Acute aortic dissection
9. The patient opposes the test.
Relative Contraindications:
1. Left main coronary stenosis
2. Moderate stenotic valvular heart disease
3. Serum Electrolyte abnormalities
4. Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood
pressure >110 mmHg)
5. Tachyarrhythmias or bradyarrhythmias
6. Hypertrophic cardiomyopathy
7. Patients can not cooperate because of mental impairment or physical disability
8. High-degree AV block

SE-1515 PC ECG User Manual Safety Guidance
- 8 -
1.3 List of Symbols
No.
Symbol
Description
1
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
2
Caution
3
Operating instructions
4
General symbol for recovery/recyclable
5
Part Number
6
SERIAL NUMBER
7
Date of manufacture
8
MANUFACTURER
9
CLASS II equipment
10
AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY
11
Transmission Status Indicator of Bluetooth
12
Power Supply Indicator of DX12 Receiver

SE-1515 PC ECG User Manual Safety Guidance
- 9 -
13
Start printing button (on DE15&DE18)
14
CE marking
15
Disposal method
16
Caution: Federal (U.S.) law restricts this device to sale by or on
the order of a physician.
17
Federal Communications Commission:
FCC ID:SMQDX12TREDAN (for DX12 Transmitter)
FCC ID:SMQDX12REEDAN (for DX12 Receiver)
18
Refer to User Manual
(Background: Blue; Symbol: White)
19
Warning
(Background: Yellow; Symbol&Outline: Black)
20
Non- ionizing electromagnetic radiation
21
MR Unsafe–Keep away from magnetic resonance
imaging (MRI) equipment
NOTE: The user manual is printed in black and white.

SE-1515 PC ECG User Manual Introduction
- 10 -
Chapter 2 Introduction
The SE-1515 system consists of the following equipment:
18-lead ECG sampling system (18-lead ECG sampling box)
Or, 16-lead ECG sampling system (16-lead ECG sampling box)
Or, 12-lead wired ECG sampling system (12-lead ECG sampling box)
Or, 12-lead wireless ECG sampling system (wireless DX12 transmitter and receiver)
PC ECG software
Patient cable
Disposable electrodes
USB cable
According to the configurations of different types of workstations, the following purchased
accessories can also be included: tablet, computer, screen, printer, treadmill/ergometer, and
exercise BP monitor.
NOTE: The pictures and windows in this manual are for reference only.
WARNING
1. Use a special grounded socket to get accurate voltage and current.
2. When using a laptop with a two-prong plug, please connect a grounded printer to avoid
power interference.
3. Only stress BP monitors can be used.

SE-1515 PC ECG User Manual Introduction
- 11 -
2.1 Wired SE-1515 System
2.1.1 Wired System Connection Diagram
1. Resting ECG of Wired SE-1515 System
2. Exercise ECG of Wired SE-1515 System

SE-1515 PC ECG User Manual Introduction
- 12 -
2.1.2 Assembling the Wired System
The DE15 ECG sampling box is used as an example here:
Patient Cable DE15 ECG sampling box
Resting ECG Cable Exercise ECG Cable
Assembly Drawing
1
7
8
6
5
4
2
3

SE-1515 PC ECG User Manual Introduction
- 13 -
1) Insert plug 1 of the patient cable into socket 2 of DE15 ECG sampling box.
2) Insert plug 7 of the cable into socket 3 of DE15 ECG sampling box.
3) Insert plug 8 of the cable into the USB socket of the PC.
4) Connect plug 6 of the cable to the BP monitor (for exercise ECG only).
5) Connect a treadmill or an ergometer to the PC (for exercise ECG only).
6) Connect a printer to the PC.
7) Insert the Sentinel into the USB socket of the PC if the Sentinel is purchased.
8) Make sure that the above parts are properly connected, and then connect the PC,
treadmill/ergometer and printer to the power supply.
2.1.3 ECG Sampling Box
WARNING
1. When the computer connected to the USB cable is powered on, do not connect the
USB cable to the ECG sampling box; when the system is powered on, do not
disconnect the USB cable from the ECG sampling box.
2. It is not necessary or recommended to regularly disconnect the USB cable from the
ECG sampling box. Disconnect the USB cable from the PC if necessary.
3. When connecting the sampling box to the PC, do not connect them via an USB HUB.
4. When a sampling box is connected the PC, no other device should be connected to the
PC for battery enchargement through an USB cable.
2.1.3.1 DE15/DE18 ECG sampling box
Name
Explanation
Indicator
When the ECG sampling box is powered by the PC, the
indicator will be lit.
USB Interface
Connecting to the USB socket of the PC with a USB cable
USB Interface
Indicator