EDAN INSTRUMENTS DX12TEDAN User Manual
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.
I
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.
II
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 3 Assembling 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
III
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
IV
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
V
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 Detecting Arrhythmia ........................................... 125
9.2.5 Setting Background Grid....................................................................................... 125
VI
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
VII
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 12 Accessories .............................................................................................................. 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
VIII
SE-1010 PC ECG User Manual Safety Guidance
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.
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SE-1010 PC ECG User Manual Safety Guidance
WARNING
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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SE-1010 PC ECG User Manual Safety Guidance
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
configurations 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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SE-1010 PC ECG User Manual Safety Guidance
WARNING
25. 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.
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.
1.2.2 Battery Care Warnings
WARNING
1. Improper operation may cause the internal 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.
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.
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SE-1010 PC ECG User Manual Safety Guidance
1.2.3 General Cautions
CAUTION
1. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.
2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
3. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.
4. Ruptured fuse must only be replaced with that of the same type and rating as the
original.
5. The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of
them together with house-hold garbage. At the end of their lives hand the batteries
over to the applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or battery, please contact your
local Civic Office, or the shop where you purchased the product.
6. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
1.2.4 Operation 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.
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SE-1010 PC ECG User Manual Safety Guidance
1.2.5 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 there are at least 2 experienced physicians
present. One of them observes the patient and deals with the emergency.
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.
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SE-1010 PC ECG User Manual Safety Guidance
1.2.6 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. 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
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SE-1010 PC ECG User Manual Safety Guidance
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
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SE-1010 PC ECG User Manual Safety Guidance
Class Ⅱ
Transmission Status Indicator of Bluetooth
Burglar Lock
Power Supply Indicator of DX12 Receiver
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(for DX12 Transmitter)
(for DX12 Receiver)
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired
operation.
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SE-1010 PC ECG User Manual Introduction
Chapter 2 Introduction
SE-1010 PC ECG 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. SE-1010 PC ECG can also be invocated by Smart ECG Net
version 1.3 or above.
When a patient with coronary heart disease runs, the added heart load will cause myocardium
hypotension, and then the ECG will change abnormally. Therefore, with the function of exercise
ECG, SE-1010 PC ECG can also be used to diagnose concealed coronary heart disease and
atypical angina pectoris, prescribe the workload for patients with myocardial infarction before
they leave hospital, and assess the effect of the treatment. With SE-1010 PC ECG, doctors’
workload can be reduced greatly.
NOTE:
1. The exercise ECG function is optional. It is available only if you purchased this
function.
2. The pictures and windows in this manual are for reference only.
2.1 SE-1010 PC ECG System
SE-1010 PC ECG system includes the following equipment:
1. PC ECG software
2. ECG Sampling Box (wired or wireless system)
3. Patient Cable
4. Electrodes
5. Sentinel
6. USB Cable
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SE-1010 PC ECG User Manual Introduction
Wired System of SE-1010 PC ECG System
1. Resting ECG of Wired System
Patient
Patient Cable
Resting
PC (Manually
Configured)
USB Cable
Printer (Manually
Configured)
2. Exercise ECG of Wired System
Treadmill or Ergometer
(Manually Configured)
ECG Cable
DP12 ECG
Sampling Box
PC (Manually
Configured)
Printer (Manually
Configured)
Serial
Cable
USB Cable
Exercise
ECG Cable
Patient
Patient Cable
DP12 ECG
Sampling Box
Exercise
ECG Cable
BP Monitor
(Manually
Configured)
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SE-1010 PC ECG User Manual Introduction
Receiver
ECG Cable
Wireless System of SE-1010 PC ECG System
The DX12 device which consists of transmitter and receiver has passed FCC certification. This
device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
1. Resting ECG of Wireless System
Patient
Patient Cable
Resting
PC (Manually
DX12
Configured)
USB Cable
Printer (Manually
Configured)
2. Exercises ECG of Wireless System
Treadmill or Ergometer
(Manually Configured)
Serial
Cable
DX12
Transmitter
Patient
Patient Cable
PC (Manually
Configured)
USB Cable
Printer (Manually
Configured)
Exercise
DX12
Receiver
Exercise
ECG Cable
BP Monitor
(Manually
Configured
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DX12
Transmitter
SE-1010 PC ECG User Manual Introduction
3. FCC Statement
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates
and can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct
The interference by one or more of the following measures:
1. Reorient or relocate the receiving antenna.
2. Increase the separation between the equipment and receiver.
3. Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
4. Consult the dealer or an experienced radio/TV technician for help.
This device complies with Part 15 of FCC Rules. Operation is subject to the following two
conditions:
1. This device may not cause harmful interference,
2. And this device must accept any interference received, including interference that
may cause undesired operation.
NOTE: The manufacturer is not responsible for any radio or TV interference caused by
unauthorized modifications to this equipment. such modifications could void
the user’s authority to operate this equipment.
WARNING
The system should be installed by a qualified service engineer. Do not power on the
system until all cables are properly connected and verified.
2.2 DP12 ECG Sampling Box of Wired System
DP12 ECG Sampling Box Appearance
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SE-1010 PC ECG User Manual Introduction
Front Panel
Lamp
USB Socket
Name Explanation
When the ECG sampling box is powered by the PC, the lamp
Lamp
will be lit.
USB Socket Connecting to the USB socket of the PC with a USB cable
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SE-1010 PC ECG User Manual Introduction
USB Socket
Definitions of corresponding pins:
Pin Signal Pin Signal
1
2
3
4
5
GND
VCC
QRS
GND
GND
6
7
8
9
10
GND
GND
GND
D-
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.
Back Panel
Patient Cable Socket
: Applied part of type CF with defibrillator proof
: Caution
- 15 -
SE-1010 PC ECG User Manual Introduction
Patient Cable Socket
Definitions of corresponding pins:
Pin Signal Pin Signal Pin
1
2
C2 / V2
C3 / V3
6
7
SH
NC
11
12
Signal
F / LL
C1 / V1
or NC
3
4
C4 / V4
C5 / V5
8
9
NC
R / RA
13
14
C1 / V1
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.
Top Panel and Bottom Panel
Screw
Decorative
Chip
Label
- 16 -
SE-1010 PC ECG User Manual Introduction
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.
2.3 DX12 ECG Sampling Boxes of Wireless System
DX12 Transmitter Appearance
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SE-1010 PC ECG User Manual Introduction
Front Panel
Patient Cable Socket
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
2
3
4
5
NC
F/LL
NC
C6/V6
NC
6
7
8
9
10
C5/V5
NC
C4/V4
NC
C3/V3
11
12
13
14
15
NC
C2/V2
NC
C1/V1
NC
16
17
18
19
20
L/LA
NC
R/RA
NC
N/RL
NOTE: The left side of “/” is European standard, and the right side is American standard.
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