EDAN SE-1010 User manual

I
About this Manual
P/N: 01.54.106666-17
Release Date: July 2010
© Copyright EDAN INSTRUMENTS, INC. 2008-2010. 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 ofContents
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 General Cautions....................................................................................................... 3
1.2.3 Preparation and Operation Warnings (for Exercise ECG) ........................................5
1.2.4 Contraindications (for Exercise ECG) ......................................................................6
1.3 List of Symbols ...................................................................................................................7
Chapter 2 Introduction..................................................................................................................8
2.1 SE-1010 PC ECG System ................................................................................................... 8
2.2 ECG Sampling Box Appearance.......................................................................................10
2.3 Features .............................................................................................................................13
Chapter 3Assembling SE-1010 PC ECG System......................................................................15
Chapter 4 Installing SE-1010 PC ECG Software......................................................................17
4.1 System Running Environment ..........................................................................................17
4.1.1 Requirements on the Hardware of the PC............................................................... 17
4.1.2 Requirements on the Software of the PC ................................................................ 17
4.2 About Installation Interface...............................................................................................18
Chapter 5 Preparations Before Operation.................................................................................19
5.1 Preparing the Patient .........................................................................................................19
5.1.1 Instructing the Patient .............................................................................................19
5.1.2 Preparing the Skin................................................................................................... 19
5.2 Connecting the Patient Cable to the Electrodes ................................................................19
5.3 Attaching Electrodes (for Resting ECG)...........................................................................20
5.3.1 Wilson Lead System................................................................................................21
5.3.2 Frank Lead System..................................................................................................22
5.3.3 Attaching Electrodes to the Patient .........................................................................22
5.4 Attaching Electrodes to the Patient (for Exercise ECG) ...................................................24
5.5 Inspection Before Test.......................................................................................................26
Chapter 6 Operation Instructions for Resting ECG.................................................................28
6.1 Viewing Lead Placement Information...............................................................................29
6.2 Selecting a Patient Record to Start a New Test.................................................................29
6.3 Entering New Patient Information ....................................................................................32
6.4 Selecting Sampling Type................................................................................................... 34
6.5 Sampling Resting ECG .....................................................................................................34
6.5.1 Specifying Display Mode........................................................................................35
6.5.2 Specifying Lowpass Filter.......................................................................................36
6.5.3 Specifying Gain.......................................................................................................36

IV
6.5.4 Specifying Speed.....................................................................................................36
6.5.5 Recording ECG Data...............................................................................................36
6.5.6 Freezing and Previewing ECG................................................................................37
6.5.7 Stopping Sampling Data .........................................................................................38
6.5.8 Printing ECG Waves ...............................................................................................38
6.6 Analyzing ECG Data.........................................................................................................39
6.6.1 Analyzing Normal ECG ..........................................................................................39
6.6.1.1 Viewing the Waveform..................................................................................39
6.6.1.2 About the Average Template Interface ..........................................................42
6.6.1.3 About the Detail Information Interface .........................................................43
6.6.1.4 Previewing Normal ECG .............................................................................. 44
6.6.2 Analyzing QT Dispersion........................................................................................45
6.6.2.1 Editing Waveform on the QT Dispersion Interface.......................................46
6.6.2.2 About QT Value............................................................................................. 47
6.6.2.3 Previewing QT Dispersion............................................................................ 47
6.6.3 Analyzing Frequency ECG .....................................................................................48
6.6.3.1 About Two-lead Comparison Interface ......................................................... 48
6.6.3.2 About 12-lead Power Spectrum Interface .....................................................51
6.6.3.3 Previewing Frequency ECG..........................................................................51
6.6.4 Analyzing High Frequency ECG ............................................................................53
6.6.5 Analyzing HRV .......................................................................................................55
6.6.5.1 Editing the HRV Data on the Analysis Interface........................................... 56
6.6.5.2 Editing the HRV Waveform on the Waveform Interface ..............................57
6.6.5.3 Previewing HRV ...........................................................................................58
6.6.5.4 Printing HRV Wave.......................................................................................58
6.6.6 Analyzing HRT........................................................................................................59
6.6.7 Analyzing Vector ECG............................................................................................ 61
6.6.7.1 Displaying Vector ECG with All Plane and All Loop...................................62
6.6.7.2 Displaying Vector ECG with Frontal Plane and QRS Loop .........................64
6.6.7.3 Displaying 3D Vector ECG........................................................................... 65
6.6.7.4 Previewing Vector ECG ................................................................................ 66
6.6.8 Analyzing Time Vector ECG................................................................................... 66
6.6.9 Analyzing Signal Averaged ECG ............................................................................68
6.6.9.1 About the Time Domain Interface................................................................. 69
6.6.9.2 About the Frequency Domain Interface ........................................................69
6.6.9.3 Previewing Signal Averaged ECG ................................................................ 70
6.6.10 Printing ECG Reports ...........................................................................................71
6.6.11 Saving ECG Reports .............................................................................................72
6.7 Sampling STAT ECG ........................................................................................................ 73
Chapter 7 Operation Instructions for Exercise ECG ...............................................................74

V
7.1 Viewing Lead Placement Information...............................................................................74
7.2 Selecting a Patient Record to Start a New Test.................................................................75
7.2.1 Setting Target HR....................................................................................................76
7.2.2 Setting Normal BP ..................................................................................................76
7.2.3 Setting a Protocol .................................................................................................... 77
7.2.4 Setting Post J...........................................................................................................77
7.2.5 Setting BP Sampling Mode..................................................................................... 77
7.2.6 Setting BP Triggering Mode ...................................................................................77
7.2.7 Setting Auto Printing...............................................................................................78
7.3 Entering New Patient Information ....................................................................................78
7.4 Pre-sampling ECG ............................................................................................................80
7.5 Pretest Phase......................................................................................................................81
7.5.1 Viewing the Heart Rate and the Blood Pressure .....................................................82
7.5.2 Viewing Other Information .....................................................................................83
7.5.3 Editing the Waveform ............................................................................................. 83
7.5.4 Printing the Pretest Report ...................................................................................... 85
7.6 Exercise Phase...................................................................................................................85
7.7 Recovery Phase .................................................................................................................86
7.8 Exiting the Exercise Test...................................................................................................87
7.9 About Analysis Interface................................................................................................... 88
7.9.1 About Summary Interface .......................................................................................88
7.9.2 About ST Analysis Interface ...................................................................................91
7.9.3 About All View Review Interface ........................................................................... 93
7.9.4 About Trend Interface ............................................................................................. 96
7.9.5 About ECG Strip Interface ......................................................................................96
7.9.6 Previewing ECG Reports ........................................................................................ 97
7.9.7 Printing ECG Reports .............................................................................................97
7.9.8 Saving ECG Reports ............................................................................................... 98
7.9.9 Exiting the Analysis Interface ................................................................................. 98
Chapter 8 Processing Patient Records.......................................................................................99
8.1 Searching Patient Records.................................................................................................99
8.2 Modifying Patient Records .............................................................................................101
8.3 Deleting Records............................................................................................................. 102
8.3.1 Deleting Patient Records....................................................................................... 102
8.3.2 Deleting Examination Records of a Patient ..........................................................102
8.4 Selecting a Patient Record ..............................................................................................102
8.5 Merging Examination Records .......................................................................................103
8.6 Comparing Two Examination Records ........................................................................... 103
8.7 Importing ECG Data into the Data Manager Interface ...................................................104
8.8 Exporting ECG Data from the Data Manager Interface..................................................105

VI
8.9 Viewing an Examination Record.....................................................................................106
Chapter 9 Configuring the System...........................................................................................107
9.1 Basic Information Setup..................................................................................................107
9.1.1 Setting Basic Information .....................................................................................108
9.1.2 Setting ID Mode....................................................................................................109
9.1.3 Setting Name Mode............................................................................................... 110
9.1.4 Selecting D.O.B .................................................................................................... 110
9.1.5 Setting Language................................................................................................... 111
9.1.6 Specifying the Storage Path of the ECG Data ...................................................... 111
9.2 Sample Setup................................................................................................................... 112
9.2.1 Setting Filter.......................................................................................................... 112
9.2.2 Setting Sampling Time.......................................................................................... 113
9.2.3 Setting Lead Sequence .......................................................................................... 113
9.2.4 Setting Pacemaker Detection ................................................................................ 113
9.2.5 Setting HR Calculation Lead ................................................................................ 114
9.2.6 Selecting Auto Printing When Detecting Arrhythmia........................................... 114
9.2.7 Setting Auto Upload When Stopping Sampling.................................................... 114
9.2.8 Setting Background Grid ...................................................................................... 114
9.2.9 Setting Anti-aliasing.............................................................................................. 114
9.2.10 Selecting QRS Voice ........................................................................................... 114
9.3 Device Setup ................................................................................................................... 115
9.3.1 Setting Sampling Device....................................................................................... 115
9.3.2 Setting Device Type/Mode.................................................................................... 116
9.3.3 Setting COM Port of Sample/Treadmill/BP Monitor............................................ 116
9.3.4 Setting a Protocol .................................................................................................. 116
9.3.4.1 Creating a New Protocol ............................................................................. 116
9.3.4.2 Modifying a Protocol .................................................................................. 117
9.3.4.3 Deleting a Protocol...................................................................................... 118
9.3.4.4 Restoring the Factory Settings .................................................................... 119
9.4 Printer Setup.................................................................................................................... 119
9.4.1 Choosing Patient Information to be Printed.......................................................... 119
9.4.2 Choosing Diagnosis Information to be Printed.....................................................120
9.4.3 Setting Rhythm Lead.............................................................................................120
9.4.4 Defining Printing Format ......................................................................................120
9.5 Other Setup......................................................................................................................121
9.6 GDT Setup ......................................................................................................................122
9.7 Modifying the Glossary...................................................................................................123
Chapter 10 Hint Information....................................................................................................124
Chapter 11 Cleaning and Maintenance....................................................................................126
11.1 Cleaning and Maintaining the Treadmill.......................................................................126

VII
11.2 Cleaning and Maintaining the Patient Cable and Reusable Electrodes ........................126
11.3 Disinfection ...................................................................................................................127
Chapter 12 Accessories ..............................................................................................................128
Chapter 13 Warranty and Service Policy ................................................................................129
13.1 Warranty ........................................................................................................................129
13.2 Service Policy................................................................................................................129
Chapter 14 Recommended OptionalAccessories....................................................................131
Appendix 1 Technical Specifications........................................................................................133
A1.1 Safety Specifications ....................................................................................................133
A1.2 Environment Specifications .........................................................................................133
A1.3 Physical Specifications.................................................................................................134
A1.4 Power Supply Specifications........................................................................................134
A1.5 Performance Specifications.......................................................................................... 134
Appendix 2 EMC Information..................................................................................................136
Appendix 3 Abbreviation...........................................................................................................140

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.
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.
Notes:
1. This system is not intended for home use.
2. The pictures and interfaces in this manual are for reference only.
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.
3. The results given by the system should be examined based on the overall clinical
condition of the patient, and it can not substitute for regular checking.
4. This system is not intended for treatment.
5. This system is not designed for direct cardiac application.

SE-1010 PC ECG User Manual Safety Guidance
- 2 -
WARNING
6. EXPLOSION HAZARD - Do not use the system in the presence of flammable
anesthetic mixtures with oxygen or other flammable agents.
7. 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.
8. Do not use this system in the presence of high static electricity or high voltage
equipment which may generate sparks.
9. In order to avoid being burnt, please keep the electrodes far away from the radio
knife while using electrosurgical equipment.
10. Only the patient cable supplied by the manufacturer can be used. Or else, the
performance and electric shock protection can not be guaranteed.
11. Turn off the system power and remove the power cable before servicing or
maintaining the system.
12. Please do not operate the system during servicing or before it is running normally.
13. Make sure that all electrodes are connected to the patient correctly before operation.
14. 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.
15. Electrodes with defibrillator protection should be used while defibrillating.
16. The disposable electrodes can only be used for one time.
17. Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.
18. Do not touch the patient, bed, table or the system simultaneously while using the
system together with a defibrillator.
19. If reusable electrodes with electrode gel are used during defibrillation, the ECG
recovery will take more than 10 seconds. The manufacturer recommends the use of
disposable electrodes at all times.
20. 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.