EDAN SE-101 User manual

I
About this Manual
P/N: 01.54.106666-21
Release Date: June 2013
© Copyright EDAN INSTRUMENTS, INC. 2008-2013. 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 Battery Care Warnings ..............................................................................................4
1.2.3 General Cautions.......................................................................................................5
1.2.4 Operation for Wireless System..................................................................................5
1.2.5 Preparation and Operation Warnings (for Exercise ECG)........................................6
1.2.6 Contraindications (for Exercise ECG) ......................................................................7
1.3 List of Symbols...................................................................................................................8
Chapter 2 Introduction................................................................................................................10
2.1 SE-1010 PC ECG System.................................................................................................10
2.2 DP12 ECG Sampling Box of Wired System.....................................................................13
2.3 DX12 ECG Sampling Boxes of Wireless System.............................................................17
2.4 Features.............................................................................................................................20
Chapter 3Assembling SE-1010 PC ECG System......................................................................22
3.1 Assembling Wired System ................................................................................................22
3.2 Assembling Wireless System ............................................................................................24
Chapter 4 Installing SE-1010 PC ECG Software......................................................................27
4.1 System Running Environment ..........................................................................................27
4.1.1 Requirements on the Hardware of the PC...............................................................27
4.1.2 Requirements on the Software of the PC................................................................27
4.2 About Installation Window ...............................................................................................28
Chapter 5 Preparations Before Operation.................................................................................29
5.1 Preparing the Patient.........................................................................................................29
5.1.1 Instructing the Patient .............................................................................................29
5.1.2 Preparing the Skin...................................................................................................29
5.2 Connecting the Electrodes of Wired System.....................................................................30
5.3 Connecting the Electrodes of Wireless System.................................................................31
5.4 Attaching Electrodes (for Resting ECG)...........................................................................31
5.4.1 Wilson Lead System................................................................................................32
5.4.2 Frank Lead System..................................................................................................33
5.4.3 Attaching Electrodes to the Patient.........................................................................33
5.5 Attaching Electrodes to the Patient (for Exercise ECG)...................................................35

IV
5.6 Inspection Before Test.......................................................................................................37
5.7 Setting DX12 Transmitter (for Wireless System) .............................................................38
5.7.1 Keyboard Locking/Unlocking.................................................................................40
5.7.2 Menu Settings .........................................................................................................41
Chapter 6 Operation Instructions for Resting ECG.................................................................42
6.1 Viewing Lead Placement Information ..............................................................................43
6.2 Selecting a Patient Record to Start a New Test.................................................................44
6.3 Entering New Patient Information....................................................................................46
6.3.1 Entering New Patient Information Manually..........................................................46
6.3.2 Entering Patient Information by Using a Bar Code Reader....................................49
6.4 Selecting Sampling Type...................................................................................................50
6.5 Sampling Resting ECG.....................................................................................................50
6.5.1 Specifying Display Mode........................................................................................51
6.5.2 Specifying Lowpass Filter ......................................................................................52
6.5.3 Specifying Gain.......................................................................................................52
6.5.4 Specifying Speed.....................................................................................................52
6.5.5 Recording ECG Data...............................................................................................53
6.5.6 Freezing and Previewing ECG................................................................................53
6.5.7 Stopping Sampling Data .........................................................................................54
6.5.8 Printing ECG Waves ...............................................................................................55
6.6 Analyzing ECG Data.........................................................................................................55
6.6.1 Analyzing Normal ECG..........................................................................................55
6.6.1.1 Viewing the Waveform..................................................................................56
6.6.1.2 About the Average Template Window...........................................................58
6.6.1.3 About the Detail Information Window..........................................................60
6.6.1.4 About the Rhythm Wave Window.................................................................61
6.6.1.5 Previewing Normal ECG ..............................................................................61
6.6.2 Analyzing QT Dispersion........................................................................................63
6.6.2.1 Editing Waveform on the QT Dispersion Screen..........................................64
6.6.2.2 About QT Value.............................................................................................64
6.6.2.3 Previewing QT Dispersion............................................................................65
6.6.3 Analyzing Frequency ECG .....................................................................................66
6.6.3.1 About Two-lead Comparison Window..........................................................66
6.6.3.2 About 12-lead Power Spectrum Window......................................................68
6.6.3.3 Previewing Frequency ECG..........................................................................68
6.6.4 Analyzing High Frequency ECG ............................................................................70

V
6.6.5 Analyzing HRV.......................................................................................................72
6.6.5.1 Editing the HRV Data on the Analysis Screen..............................................73
6.6.5.2 Editing the HRV Waveform in the Waveform Window................................74
6.6.5.3 Previewing HRV ...........................................................................................75
6.6.6 Analyzing HRT........................................................................................................76
6.6.7 Analyzing Vector ECG............................................................................................78
6.6.7.1 Displaying Vector ECG with All Plane and All Loop...................................78
6.6.7.2 Displaying Vector ECG with Frontal Plane and QRS Loop.........................81
6.6.7.3 Displaying 3D Vector ECG...........................................................................81
6.6.7.4 Previewing Vector ECG................................................................................82
6.6.8 Analyzing Time Vector ECG...................................................................................83
6.6.9 Analyzing Signal Averaged ECG............................................................................85
6.6.9.1 About the Time Domain Window .................................................................85
6.6.9.2 About the Frequency Domain Window.........................................................86
6.6.9.3 Previewing Signal Averaged ECG ................................................................87
6.6.10 Printing ECG Reports ...........................................................................................88
6.6.11 Saving ECG Reports .............................................................................................88
6.7 Sampling STAT ECG ........................................................................................................89
Chapter 7 Operation Instructions for Exercise ECG ...............................................................90
7.1 Viewing Lead Placement Information ..............................................................................90
7.2 Selecting a Patient Record to Start a New Test.................................................................91
7.2.1 Setting Target HR....................................................................................................92
7.2.2 Setting Normal BP ..................................................................................................92
7.2.3 Setting a Protocol....................................................................................................92
7.2.4 Setting Post J...........................................................................................................92
7.2.5 Setting BP Sampling Mode.....................................................................................93
7.2.6 Setting BP Triggering Mode ...................................................................................93
7.2.7 Setting Auto Printing...............................................................................................93
7.3 Entering New Patient Information....................................................................................93
7.4 Pre-sampling ECG ............................................................................................................94
7.5 Pretest Phase .....................................................................................................................95
7.5.1 Viewing the Heart Rate and the Blood Pressure.....................................................96
7.5.2 Viewing Other Information.....................................................................................97
7.5.3 Editing the Waveform .............................................................................................97
7.5.4 Printing the Pretest Report......................................................................................99
7.6 Exercise Phase...................................................................................................................99

VI
7.7 Recovery Phase...............................................................................................................100
7.8 Exiting the Exercise Test.................................................................................................100
7.9 About Analysis Screen ....................................................................................................101
7.9.1 About Summary Screen.........................................................................................101
7.9.2 About ST Analysis Screen.....................................................................................103
7.9.3 About All View Review Screen.............................................................................105
7.9.4 About Trend Screen...............................................................................................107
7.9.5 About ECG Strip Screen .......................................................................................108
7.9.6 Previewing ECG Reports......................................................................................108
7.9.7 Printing ECG Reports ...........................................................................................109
7.9.8 Saving ECG Reports.............................................................................................109
7.9.9 Exiting the Analysis Screen ..................................................................................109
Chapter 8 Processing Patient Records.....................................................................................110
8.1 Searching Patient Records ..............................................................................................110
8.2 Modifying Patient Records .............................................................................................112
8.3 Deleting Records.............................................................................................................113
8.3.1 Deleting Patient Records.......................................................................................113
8.3.2 Deleting Examination Records of a Patient..........................................................113
8.4 Selecting a Patient Record ..............................................................................................113
8.5 Merging Examination Records .......................................................................................114
8.6 Comparing Two Examination Records...........................................................................114
8.7 Importing ECG Data into the Data Manager Screen ......................................................116
8.8 Exporting ECG Data from the Data Manager Screen.....................................................118
8.9 Viewing an Examination Record ....................................................................................119
Chapter 9 Configuring the System...........................................................................................120
9.1 Basic Information Setup..................................................................................................120
9.1.1 Setting Basic Information .....................................................................................121
9.1.2 Setting ID Mode....................................................................................................122
9.1.3 Setting Language...................................................................................................122
9.1.4 Specifying the Storage Path of the ECG Data.......................................................122
9.2 Sample Setup...................................................................................................................123
9.2.1 Setting Filter..........................................................................................................123
9.2.2 Setting Sampling Time..........................................................................................124
9.2.3 Others....................................................................................................................124
9.2.4 Selecting Auto Printing When DetectingArrhythmia...........................................125
9.2.5 Setting Background Grid.......................................................................................125

VII
9.2.6 Setting Anti-aliasing..............................................................................................125
9.2.7 Selecting QRS Voice.............................................................................................125
9.2.8 Selecting Sequence Mode When Sampling ..........................................................125
9.3 Device Setup ...................................................................................................................126
9.3.1 Setting Sampling Device.......................................................................................126
9.3.2 Setting Device Type/Mode....................................................................................127
9.3.3 Setting COM Port of Sample/Treadmill/BP Monitor............................................127
9.3.4 Setting a Protocol..................................................................................................127
9.3.4.1 Creating a New Protocol.............................................................................128
9.3.4.2 Modifying a Protocol ..................................................................................129
9.3.4.3 Deleting a Protocol......................................................................................130
9.3.4.4 Restoring the default protocol.....................................................................130
9.3.5 Advanced Setup.....................................................................................................130
9.3.5.1 Setting Access Network ..............................................................................130
9.3.5.2 Setting Barcode...........................................................................................131
9.4 Print Setup.......................................................................................................................133
9.4.1 Choosing Patient Information to be Printed..........................................................133
9.4.2 Choosing Diagnosis Information to be Printed.....................................................134
9.4.3 Setting Rhythm Lead.............................................................................................135
9.4.4 Defining Printing Format......................................................................................135
9.5 Output File Setup ............................................................................................................136
9.5.1 File Naming...........................................................................................................136
9.5.2 Setting PDF/JPG...................................................................................................137
9.5.3 Setting SCP ...........................................................................................................137
9.5.4 Setting FDA-XML................................................................................................137
9.5.5 Setting DICOM.....................................................................................................138
9.5.6 Specifying the Output Path ...................................................................................138
9.6 Data Maintenance Setup .................................................................................................138
9.6.1 Database Rebuild ..................................................................................................139
9.6.2 Database Backup...................................................................................................139
9.7 GDT Setup ......................................................................................................................141
9.8 Other Setup .....................................................................................................................142
9.8.1 Setting Unit and Color ..........................................................................................143
9.8.2 Setting System Password ......................................................................................143
9.8.3 Setting Wave Width and Grid Width.....................................................................143
9.9 Modifying the Glossary...................................................................................................144

VIII
Chapter 10 Hint Information....................................................................................................146
Chapter 11 Cleaning, Care and Maintenance .........................................................................148
11.1 Cleaning and Maintaining the Treadmill.......................................................................148
11.2 Cleaning and Maintaining the Patient Cable and Reusable Electrodes ........................148
11.3 Disinfection...................................................................................................................149
11.4 Maintenance of ECG Sampling Box.............................................................................149
Chapter 12Accessories ..............................................................................................................151
Chapter 13 Warranty & Service...............................................................................................153
13.1 Warranty........................................................................................................................153
13.2 Contact information ......................................................................................................153
Chapter 14 Recommended Optional Accessories....................................................................154
Appendix 1 Technical Specifications ........................................................................................156
A1.1 Safety Specifications....................................................................................................156
A1.2 Environment Specifications .........................................................................................156
A1.3 Physical Specifications.................................................................................................157
A1.4 Power Supply Specifications........................................................................................157
A1.5 Performance Specifications..........................................................................................157
Appendix 2 EMC Information..................................................................................................160
Appendix 3 Abbreviation...........................................................................................................165

SE-1010 PC ECG User Manual Safety Guidance
- 1 -
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
♦This system is not designed for intracardiac use or direct cardiac application.
♦This system is not intended for home use.
♦This system is not intended for treatment or monitoring.
♦This system is intended for use on adult and pediatric patients only.
♦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.
2. Only qualified service engineers can install this equipment, and only service
engineers authorized by the manufacturer can open the shell.