EDAN SE-1010 User manual

I
About this Manual
P/N: 01.54.455698-10
Release Date: August 2012
© Copyright EDAN INSTRUMENTS, INC. 2012. 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.
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.
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.

II
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........................................................................................................................1
1.2 Warnings and Cautions........................................................................................................1
1.2.1 General Warnings...................................................................................................... 1
1.2.2 Li-ion Battery Care Warnings ...................................................................................4
1.2.3 General Cautions....................................................................................................... 5
1.3 List of Symbols ...................................................................................................................6
Chapter 2 Introduction..................................................................................................................7
2.1 Assembling the System .......................................................................................................7
2.1.1 SE-1010 PC ECG System ......................................................................................... 7
2.1.2 DP12 ECG Sampling Box of the Wired System....................................................... 9
2.1.3 DX12 ECG Sampling Box of the Wireless System ................................................ 12
2.1.3.1 Keys and Icons .............................................................................................. 14
2.1.3.2 Setting the Menu ...........................................................................................15
2.2 Assembling the Software................................................................................................... 15
2.2.1 System Running Environment ................................................................................16
2.2.2 About Installation Window .....................................................................................16
2.2.3 Matching DX12 Transmitter with Tablet PC .......................................................... 17
2.3 Features .............................................................................................................................20
Chapter 3 Preparations Before Operation.................................................................................21
3.1 Preparing the Patient .........................................................................................................21
3.1.1 Instructing the Patient .............................................................................................21
3.1.2 Preparing the Skin................................................................................................... 21
3.2 Connecting the Patient Cable............................................................................................ 21
3.3 Attaching Electrodes ......................................................................................................... 22
3.3.1 Electrode Placement................................................................................................ 23
3.3.2 Attaching the Reusable Electrodes..........................................................................24
3.3.2.1 Attaching the Limb Electrodes......................................................................24
3.3.2.2 Attaching the Chest Electrodes ..................................................................... 25
3.3.3 Attaching the Disposable Electrodes.......................................................................25
Chapter 4 Sampling Resting ECG..............................................................................................26
4.1 Viewing Lead Placement Information...............................................................................27
4.2 Viewing Patient Information ............................................................................................. 27

IV
4.3 Entering Patient Information............................................................................................. 27
4.3.1 Entering Patient Information Manually ..................................................................28
4.3.2 Entering Patient Information by Using a Bar Code Reader.................................... 29
4.3.3 Entering Patient Information by Acquiring Orders................................................. 29
4.4 Sampling ECG Data.......................................................................................................... 30
4.5 Sampling STAT ECG ........................................................................................................ 31
Chapter 5 Analyzing ECG Data..................................................................................................32
5.1 Analyzing Normal ECG ....................................................................................................32
5.2 Measuring ECG.................................................................................................................34
5.3 Viewing Parameters and Diagnosis................................................................................... 35
5.4 Previewing ECG Report....................................................................................................35
5.5 Printing ECG Reports .......................................................................................................37
5.6 Saving ECG Reports .........................................................................................................37
Chapter 6 Processing Orders......................................................................................................39
6.1 Loading Orders..................................................................................................................39
6.2 Creating and Editing Orders..............................................................................................40
6.3 Examining Orders .............................................................................................................40
6.4 Deleting Orders .................................................................................................................40
6.5 Setting Orders....................................................................................................................41
Chapter 7 Processing Records ....................................................................................................43
7.1 Selecting and Modifying Patient Records......................................................................... 44
7.2 Viewing an Examination Record.......................................................................................44
7.3 Deleting Records............................................................................................................... 45
7.4 Merging Examination Records .........................................................................................45
7.5 Comparing Two Examination Records ............................................................................. 45
7.6 Importing ECG Data into the Data Manager Screen ........................................................46
7.7 Exporting ECG Data from the Data Manager Screen....................................................... 47
Chapter 8 Configuring the System.............................................................................................48
8.1 Basic Information Setup....................................................................................................48
8.2 Sample Setup.....................................................................................................................49
8.3 Device Setup .....................................................................................................................51
8.4 Advanced Setup.................................................................................................................52
8.5 Print Setup......................................................................................................................... 55
8.6 Output File Setup ..............................................................................................................57

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8.7 Data Maintenance Setup ...................................................................................................58
8.8 GDT Setup ........................................................................................................................ 59
8.9 Other Setup........................................................................................................................60
8.10 Modifying the Glossary...................................................................................................61
Chapter 9 Hint Information........................................................................................................63
Chapter 10 Cleaning, Care and Maintenance...........................................................................65
10.1 Cleaning ..........................................................................................................................65
10.1.1 Cleaning Tablet PC and the Patient Cable ............................................................65
10.1.2 Cleaning the Reusable Electrodes......................................................................... 65
10.2 Disinfection.....................................................................................................................66
10.3 Care and Maintenance.....................................................................................................66
Chapter 11 Accessories ................................................................................................................68
Chapter 12 Warranty & Service.................................................................................................69
12.1 Warranty ..........................................................................................................................69
12.2 Contact information ........................................................................................................69
Appendix 1 Technical Specifications..........................................................................................70
A1.1 Safety Specifications ......................................................................................................70
A1.2 Environment Specifications ...........................................................................................70
A1.3 Physical Specifications...................................................................................................71
A1.4 Power Supply Specifications..........................................................................................71
A1.5 Performance Specifications............................................................................................ 71
Appendix 2 EMC Information....................................................................................................74
Appendix 3 Abbreviation.............................................................................................................79

SE-1010 PC ECG User Manual Safety Guidance
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Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of SE-1010 PC ECG.
1.1 Intended Use
SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG
signals from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010
PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained
healthcare professionals. The cardiogram recorded by SE-1010 PC ECG 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 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 can not 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.

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WARNING
2. Only qualified service engineers can install this equipment, and only service
engineers authorized by the manufacturer can open the shell.
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 can not 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. Make sure that all electrodes are connected to the patient correctly before operation.
7. 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.
8. If reusable electrodes with electrode gel are used during defibrillation, the system
recovery will take more than 10 seconds. The manufacturer recommends the use of
disposable electrodes at all times.
9. Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.
10.The disposable electrodes can only be used for one time.
11.Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.
12.Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously.
13.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.
14.Fix attention on the examination to avoid missing important ECG waves.
15.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.

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WARNING
16.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.
17.Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1-1 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.
18.Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
19.Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
20.Multiple portable socket-outlets shall not be placed on the floor.
21.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.
22.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 60601-1-1. 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.
23.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.
24.All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.

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WARNING
25.You should purchase computer, printer, 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.
26.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.
27.Connecting to other devices may decrease the antistatic gradation of the system
during operation.
28.Make sure that there is no intense electromagnetic interference source around when
using the wireless system of PC ECG.
29.Do not open the battery cover of DX12 transmitter when using the wireless system of
PC ECG.
30.The tablet shall comply with the valid version of the standard IEC 60950 and be used
outside the patient environment (at least 2 meters away from the patient). The tablet
PC shall be charged outside the patient environment, and no operations are permitted
during the charging.
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. Batteries of the same model and specification as manufacture configuration should be
used.
3. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
4. Do not heat or splash the battery or throw it into fire or water.
5. 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.

SE-1010 PC ECG User Manual Safety Guidance
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WARNING
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. Remove the battery from the transmitter if the system won’t be used for a long time.
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. 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.

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1.3 List of Symbols
Equipment or part of CF type with defibrillator proof
Caution
Consult Instructions for Use
Recycle
Part Number
Serial Number
Date of Manufacture
Manufacturer
Authorized Representative in the European Community
The symbol indicates that the device complies with the
European Council Directive 93/42/EEC concerning medical
devices.
It indicates that the device should be sent to the special agencies
according to local regulations for separate collection after its
useful life.
Rx only (U.S.) Federal (US) law restricts this device to sale by or on the order
of a physician
Class Ⅱ

SE-1010 PC ECG User Manual Introduction
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Chapter 2 Introduction
SE-1010 PC ECG is a mobile PC ECG workstation, which has similar functions with an ordinary
electrocardiograph. ECG data can be sampled, analyzed and stored in a PC, and it can be saved in
PDF, Word, BMP or JPG format. ECG waves can be frozen and reviewed. Auto measurement and
diagnosis are available, and the diagnosis template can be edited. Moreover, SE-1010 PC ECG
can transmit ECG data to Smart ECG Net system over LAN.
With a large capacious built-in battery, a portable and compact size, SE-1010 PC ECG is suitable
for doctors’ inspections and visits and can perform a reliable data recording anywhere at any
time.
SE-1010 PC ECG includes the following equipment, you can also purchase the tablet PC.
♦DP12 ECG sampling box
♦PC ECG software
♦ECG Sampling Box (wired or wireless system)
♦Patient Cable
♦Electrodes
♦Sentinel
♦USB Cable
NOTE: The pictures and windows in this manual are for reference only.
2.1 Assembling the System
2.1.1 SE-1010 PC ECG System
The docking station configured with the tablet PC includes 3 USB interfaces, 1 net port and 1
HDMI port. You can connect the printer, keyboard or mouse by using the USB interfaces.
1. The Wired System
ECG Cable DP12 ECG
Sampling Box Patient Cable
Tablet PC Patient

SE-1010 PC ECG User Manual Introduction
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2. The Wireless System
WARNING
DX12 transmitter of the wireless system uses the Bluetooth technology, which could
make the patient with the pacemaker uncomfortable. Keep DX12 transmitter far away
from the pacemaker when using the wireless system of PC ECG.
Tablet PC
Patient Cable
DX12 ECG
Sampling Box
Patient

SE-1010 PC ECG User Manual Introduction
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WARNING
1. 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 60601-1-1.
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.
2. 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.
2.1.2 DP12 ECG Sampling Box of the Wired System
DP12 ECG Sampling Box Appearance

SE-1010 PC ECG User Manual Introduction
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Front Panel
Name Explanation
Lamp When the ECG sampling box is powered by the PC, the lamp
will be lit.
USB Socket Connecting to the USB socket of the PC with a USB cable
USB Socket
Definitions of corresponding pins:
Pin Signal Pin Signal
1 GND 6 GND
2 VCC 7 GND
3 QRS 8 GND
4 GND 9 D-
5 GND 10 D+
WARNING
1. When the computer connected to the USB cable is powered on, do not connect the
USB cable to the DP12 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
DP12 ECG sampling box. Disconnect the USB cable from the PC if necessary.
Lamp USB Socket

SE-1010 PC ECG User Manual Introduction
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Back Panel
: Applied part of type CF with defibrillator proof
: Caution
Patient Cable Socket
Definitions of corresponding pins:
Pin Signal Pin Signal Pin Signal
1 C2 / V2 6 SH 11 F / LL
2 C3 / V3 7 NC 12 C1 / V1
or NC
3 C4 / V4 8 NC 13 C1 / V1
4 C5 / V5 9 R / RA 14 RF (N) /RL
or NC
5 C6 / V6 10 L / LA 15 RF (N) / RL
NOTE: The left side of “/” is European standard, and the right side is American standard.
Patient Cable Socket

SE-1010 PC ECG User Manual Introduction
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Top Panel and Bottom Panel
2.1.3 DX12 ECG Sampling Box of the Wireless System
DX12 TransmitterAppearance
Decorative
Chip
Label
Screw

SE-1010 PC ECG User Manual Introduction
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Front Panel
Patient Cable Socket
：Applied part of type CF with defibrillator proof
：Caution
Definitions of corresponding pins:
Pin Signal Pin Signal Pin Signal Pin Signal
1 NC 6 C5/V5 11 NC 16 L/LA
2 F/LL 7 NC 12 C2/V2 17 NC
3 NC 8 C4/V4 13 NC 18 R/RA
4 C6/V6 9 NC 14 C1/V1 19 NC
5 NC 10 C3/V3 15 NC 20 N/RL
NOTE: The left side of “/” is European standard, and the right side is American standard.
Patient Cable Socket

SE-1010 PC ECG User Manual Introduction
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2.1.3.1 Keys and Icons
Main Screen Menu Screen
Keys/Icons Description
After batteries are installed, press this key to turn on/off DX12
transmitter.
When the Menus screen is displayed, press this key to return to the
previous screen.
When the Main or Menu screen is displayed, press this key to enter the
next menu.
Press this key, and then press in 1.2 seconds to lock / unlock the
keypad.
When the Main screen is displayed, press this key to switch the lead.
When the Menu screen is displayed, press this key to display an item in
black.
Icon for Bluetooth Connection
If this icon is not displayed on the main screen, you need to match the
device manually.