EDAN INSTRUMENTS DX12REEDAN ECG sampling box with Bluetooth User Manual SE 1515 PC ECG
EDAN INSTRUMENTS, INC. ECG sampling box with Bluetooth SE 1515 PC ECG
User manual
I
About this Manual
P/N: 01.54.455911
MPN: 01.54.455911018
Release Date: Oct. 2016
© Copyright EDAN INSTRUMENTS, INC. 2013-2016. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User's operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
II
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.
III
Contents
Chapter 1 Safety Guidance ........................................................................................................... 1
1.1 Indications for Use/Intended Use ........................................................................................ 1
1.2 Warnings and Cautions ........................................................................................................ 1
1.2.1 General Warnings ...................................................................................................... 1
1.2.2 General Cautions ....................................................................................................... 4
1.2.3 Operation Warnings for Wireless System ................................................................. 5
1.2.4 Preparation and Operation Warnings (for Exercise ECG) ........................................ 6
1.2.5 Contraindications (for Exercise ECG) ...................................................................... 7
1.3 List of Symbols ................................................................................................................... 8
Chapter 2 Introduction ................................................................................................................ 10
2.1 Wired SE-1515 System ..................................................................................................... 11
2.1.1 Wired System Connection Diagram ........................................................................ 11
2.1.2 Assembling the Wired System ................................................................................ 12
2.1.3 ECG Sampling Box ................................................................................................. 13
2.2 Wireless SE-1515 System ................................................................................................. 14
2.2.1 Wireless System Connection Diagram .................................................................... 14
2.2.2 Assembling Wireless System .................................................................................. 17
2.2.3 ECG Sampling Box ................................................................................................. 19
2.3 Installing the Software ...................................................................................................... 21
2.3.1 Requirements of the PC .......................................................................................... 21
2.3.2 About Installation Window ..................................................................................... 22
2.4 Features ............................................................................................................................. 22
Chapter 3 Preparations Before Operation ................................................................................. 24
3.1 Preparing the Patient ......................................................................................................... 24
3.1.1 Instructing the Patient ............................................................................................. 24
3.1.2 Cleaning the Skin .................................................................................................... 24
3.2 Connecting the Electrodes of Wired System ..................................................................... 25
3.3 Connecting the Electrodes of Wireless System ................................................................. 26
3.4 Attaching Electrodes ......................................................................................................... 27
3.4.1 Attaching Electrodes for Resting ECG ................................................................... 27
3.4.2 Electrode Placement for Exercise ECG .................................................................. 32
3.4.3 Attaching the Reusable Electrodes .......................................................................... 33
3.4.4 Attaching Disposable Electrodes............................................................................. 34
3.5 Inspection Before Test ....................................................................................................... 35
Chapter 4 ECG Sampling ............................................................................................................ 37
4.1 Initial Configuration .......................................................................................................... 37
4.2 Entering Patient Information ............................................................................................. 37
4.2.1 Entering Patient Information Manually .................................................................. 38
IV
4.2.2 Entering Patient Information by Using a Bar Code Reader .................................... 39
4.2.3 Retrieve Patient Information ................................................................................... 39
4.3 Selecting the ECG Sampling Type .................................................................................... 39
4.4 ECG Sampling .................................................................................................................. 40
4.4.1 Resting ECG Sampling ........................................................................................... 40
4.4.2 STAT ECG ............................................................................................................... 47
4.4.3 Exercise ECG Sampling .......................................................................................... 47
4.4.4 VCG Sampling ........................................................................................................ 54
4.4.5 HRV ECG Sampling ............................................................................................... 54
Chapter 5 ECG Analysis .............................................................................................................. 55
5.1 Resting ECG ..................................................................................................................... 55
5.1.1 Wave Analysis ......................................................................................................... 55
5.1.2 Average Template .................................................................................................... 57
5.1.3 About the Detail Information Window .................................................................... 57
5.1.4 About the Rhythm Wave Window ........................................................................... 58
5.1.5 History Record ........................................................................................................ 58
5.1.6 About the Parameters .............................................................................................. 58
5.2 Exercise ECG .................................................................................................................... 59
5.2.1 About the Summary Screen ..................................................................................... 59
5.2.2 About the All View Screen ...................................................................................... 61
5.2.3 About the ECG Strip Screen ................................................................................... 62
5.2.4 ST Analysis ............................................................................................................. 62
5.2.5 ST Trend .................................................................................................................. 63
5.3 VCG .................................................................................................................................. 63
5.3.1 Displaying Vector ECG with All Plane and All Loop ............................................. 64
5.3.2 Displaying Vector ECG with Frontal Plane and QRS Loop ................................... 66
5.3.3 Displaying 3D Vector ECG ..................................................................................... 67
5.4 HRV ................................................................................................................................... 68
5.5 Report Previewing ............................................................................................................. 69
5.6 Report Printing .................................................................................................................. 69
5.7 Saving ECG Reports ......................................................................................................... 69
Chapter 6 Archives ....................................................................................................................... 71
6.1 All List ............................................................................................................................... 71
6.1.1 Record Display ........................................................................................................ 71
6.1.2 Modifying Patient Information ............................................................................... 71
6.1.3 Viewing Examination Records ................................................................................ 72
6.1.4 Deleting Examination Records ............................................................................... 72
6.1.5 Merging Examination Records ............................................................................... 72
6.1.6 Searching Patient Records....................................................................................... 72
6.1.7 Import ...................................................................................................................... 73
V
6.1.8 Export ...................................................................................................................... 73
6.2 Order List .......................................................................................................................... 74
6.2.1 New Order ............................................................................................................... 74
6.2.2 Inbox ....................................................................................................................... 74
6.2.3 Searching Information ............................................................................................. 74
Chapter 7 Statistics ...................................................................................................................... 75
Chapter 8 System Setup ............................................................................................................... 76
8.1 Basic Setup ........................................................................................................................ 76
8.2 Display Setup .................................................................................................................... 77
8.3 Transmission Setup ........................................................................................................... 77
8.4 Output File Setup .............................................................................................................. 78
8.5 GDT Setup ........................................................................................................................ 79
8.6 DICOM Setup ................................................................................................................... 79
8.7 HL7 Setup ......................................................................................................................... 80
8.8 Barcode Setup ................................................................................................................... 80
8.9 Other Setup ....................................................................................................................... 81
8.9.1 Product Authorization ............................................................................................. 82
8.9.2 Advanced Setting .................................................................................................... 82
Chapter 9 Hint Information ........................................................................................................ 84
Chapter 10 Cleaning, Care and Maintenance ........................................................................... 85
10.1 General Points ................................................................................................................. 85
10.2 Cleaning .......................................................................................................................... 85
10.2.1 Cleaning the Sampling Box .................................................................................. 86
10.2.2 Cleaning the Patient Cable .................................................................................... 86
10.2.3 Cleaning the Reusable Electrodes (for Resting ECG) .......................................... 86
10.3 Disinfection ..................................................................................................................... 87
10.3.1 Disinfecting the Sampling Box ............................................................................. 87
10.3.2 Disinfecting the Patient Cable ............................................................................... 87
10.3.3 Disinfecting the Reusable Electrodes (for Resting ECG) ..................................... 87
10.4 Maintenance of ECG Sampling Box ............................................................................... 88
Chapter 11 Accessories ................................................................................................................ 89
Chapter 12 Warranty & Service ................................................................................................. 93
12.1 Warranty .......................................................................................................................... 93
12.2 Contact Information ........................................................................................................ 93
Appendix 1 Technical Specifications .......................................................................................... 94
A1.1 Safety Specifications ...................................................................................................... 94
A1.2 Environment Specifications ........................................................................................... 94
A1.3 Physical Specifications ................................................................................................... 95
A1.4 Power Supply Specifications .......................................................................................... 95
A1.5 Performance Specifications ............................................................................................ 96
SE-1515 PC ECG User Manual Safety Guidance
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Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of SE-1515.
1.1 Indications for Use/Intended Use
SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric
patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be
used only in hospitals and healthcare facilities by doctors and trained healthcare professionals.
The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart
diseases. However, the ECG with measurements and interpretive statements is offered to
clinicians on an advisory basis only.
WARNING
1. This system is not designed for intracardiac use or direct cardiac application.
2. This system is not intended for home use.
3. This system is not intended for treatment or monitoring.
4. This system is intended for use on adult and pediatric patients only.
5. The results given by the system should be examined based on the overall clinical
condition of the patient, and they cannot substitute for regular checking.
1.2 Warnings and Cautions
To use the system safely and effectively, firstly be familiar with the operation method of
Windows and read the user manual in detail to be familiar with the proper operation method for
the purpose of avoiding the possibility of system failure. The following warnings and cautions
must be paid more attention to during the operation of the system.
1.2.1 General Warnings
WARNING
1. The system is intended to be used by qualified physicians or personnel professionally
trained. They should be familiar with the contents of this user manual before
operation.
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WARNING
2. Only qualified service engineers can install this equipment, and only service
engineers authorized by the manufacturer can open the shell. Otherwise, safety
hazards may happen.
3. EXPLOSION HAZARD - Do not use the system in the presence of flammable
anesthetic mixtures with oxygen or other flammable agents.
4. SHOCK HAZARD - The power receptacle must be a hospital grade grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet.
5. Only the patient cable and other accessories supplied by the manufacturer can be
used. Or else, the performance and electric shock protection cannot be guaranteed.
The system has been safety tested with the recommended accessories, peripherals,
and leads, and no hazard is found when the system is operated with cardiac
pacemakers or other stimulators.
6. The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
7. Make sure that all electrodes are connected to the patient correctly before operation.
8. Ensure that the conductive parts of electrodes and associated connectors, including
neutral electrodes, do not come in contact with earth or any other conducting objects.
9. Disposable electrodes must be used during defibrillation.
10. Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.
11. The disposable electrodes can only be used for one time.
12. Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.
13. Do not touch accessible parts of electrical equipment and the patient simultaneously.
14. The use of equipment that applies high frequency voltages to the patient (including
electrosurgical equipment and some respiration transducers) is not supported and
may produce undesired results. Disconnect the patient data cable from the ECG
workstation, or detach the leads from the patient prior to performing any procedure
that uses high frequency surgical equipment.
15. Fix attention on the examination to avoid missing important ECG waves.
16. SHOCK HAZARD - Don't connect non-medical electrical equipment, which has been
supplied as a part of the system, directly to the wall outlet when the non-medical
equipment is intended to be supplied by a multiple portable socket-outlet with an
isolation transformer.
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WARNING
17. SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.
18. Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1 approved to the system. The operation
or use of non-approved equipment or accessories with the system is not tested or
supported, and system operation and safety are not guaranteed.
19. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
20. Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
21. Multiple portable socket-outlets shall not be placed on the floor.
22. Do not use the additional multiple portable socket-outlet or extension cord in the
medical electrical system, unless it's specified as part of the system by manufacturer.
And the multiple portable socket-outlets provided with the system shall only be used
for supplying power to equipment which is intended to form part of the system.
23. Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the standard IEC/EN 60601-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt,
consult our technical service department or your local distributor.
24. Connecting any accessory (such as external printer) or other device (such as the
computer) to this ECG workstation makes a medical system. In that case, additional
safety measures should be taken during installation of the system, and the system
shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
25. All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
26. Make sure that there is no intense electromagnetic interference source around when
using the wireless system of SE-1515. Furthermore, keep an unobstructed distance of
at most 5 meters between DX12 transmitter and the PC.
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WARNING
27. You should purchase computer, printer, treadmill, ergometer, BP monitor and bar code
reader from the manufacturer. Otherwise, the manufacturer will not be held
responsible for the maintenance of the PC hardware, operating system and other
accessories.
28. If multiple instruments are connected to a patient, the sum of the leakage currents
may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
Consult your service personnel.
29. Connecting to other devices may decrease the antistatic gradation of the system
during operation.
30. The system shall not be serviced or maintained while in use with a patient.
31. The appliance coupler or mains plug is used as isolation means from supply mains.
Position the ECG workstation in a location where the operator can easily access the
disconnection device.
32. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC information.
33. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information.
34. The equipment should not be used adjacent to or stacked with other equipment, refer
to the recommended separation distances provided in Appendix 2 EMC Information.
35. Assembly of the ECG workstation and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
36. The device is MR unsafe. It is not intended for use in an MRI environment.
37. Magnetic and electrical fields are capable of interfering with the proper performance
of the device. For this reason make sure that all external devices operated in the
vicinity of the device comply with the relevant EMC requirements. X-ray equipment or
MRI devices are a possible source of interference as they may emit higher levels of
electromagnetic radiation.
1.2.2 General Cautions
CAUTION
1. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5ºC and 40ºC during operation, and it should be kept between -20ºC and
55ºC during transportation and storage.
2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
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CAUTION
3. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.
4. The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of
them together with house-hold garbage. At the end of their lives hand the batteries
over to the applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or battery, please contact your
local Civic Office, or the shop where you purchased the product.
5. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
1.2.3 Operation Warnings for Wireless System
WARNING
1. Make sure that there is no intense electromagnetic interference source around the
wireless system.
2. Do not open the battery cover of the transmitter during operation.
3. Improper operations may heat the battery, make it on fire, explode, destroyed or
reduce its capacity. Please read the manual and the cautions carefully before using
the battery.
4. Batteries of the same model and specification as manufacture configuration should be
used.
5. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
6. Do not use the battery near fire or in an environment where the temperature is over
60ºC ; do not heat or splash the battery or throw it into fire or water.
7. Do not destroy the battery; do not pierce battery with a sharp object such as a needle;
do not hit with a hammer, step on or throw or drop to cause strong shock; do not
disassemble or modify the battery.
8. When leakage or foul smell is found, stop using the battery immediately. If your skin or
cloth comes into contact with the leakage liquid, cleanse it with clean water at once. If
the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with clean
water first and go to see a doctor immediately.
SE-1515 PC ECG User Manual Safety Guidance
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WARNING
9. Properly dispose of or recycle the depleted battery according to local regulations.
10. Remove the battery from the transmitter if the system won't be used for a long time.
1.2.4 Preparation and Operation Warnings (for Exercise ECG)
WARNING
1. Test the safety stop (mushroom type) and safety stop (cord type) of the treadmill
before using the system.
2. During the exercise test, ensure that such tests are supervised by properly trained
technician who meets competency requirements for exercise test supervision, fully
trained in cardiopulmonary resuscitation, and is supported by a physician skilled in
exercise testing or emergency medicine who is in close proximity for pretest
assessment or compliance that may raise.
3. Make sure that there is necessary valid first-aid equipment such as defibrillators,
blood-pressure meters etc, and necessary valid medication in the exercise test room.
4. Turn off the system power and disconnect the power cord from the wall outlet after
using the system.
5. Make sure that the power is turned off and the power cord is disconnected from the
AC socket before defibrillation.
6. Keep the four feet of the machine on the ground and make sure that it's stably
working.
7. The treadmill must be powered by the specific power outlet.
8. Examine the treadmill/ergometer carefully before using it.
9. The patient undergoing the exercise test should wear suitable clothes and shoes.
10. Keep hands, hair, jewelry, and loose clothing away from moving parts.
11. Don't let the patient stand on the running belt when starting the treadmill. The patient
should stand on the foot rails and hold the handrails during start-up. Wait until the
running belt is moving before placing feet on the belt.
12. To avoid the static electricity, the patient should not wear loose clothing or clothing
(such as nylon) that easily produces static electricity.
13. Stop exercising immediately when the patient feels uncomfortable or something
abnormal in the operation.
14. Press down the safety stop (mushroom type) or pull out the safety stop (cord type) to
stop the treadmill immediately when an emergency happens.
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1.2.5 Contraindications (for Exercise ECG)
Absolute Contraindications:
1. Acute MI (within 2 days)
2. High-risk unstable angina
3. Hemodynamic compromise caused by uncontrolled cardiac arrhythmia
4. Symptomatic severe aortic stenosis
5. Heart failure with clinic episode uncontrolled
6. Acute pulmonary embolus or pulmonary infarction
7. Acute myocarditis or pericarditis
8. Acute aortic dissection
9. The patient opposes the test.
Relative Contraindications:
1. Left main coronary stenosis
2. Moderate stenotic valvular heart disease
3. Serum Electrolyte abnormalities
4. Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood
pressure >110 mmHg)
5. Tachyarrhythmias or bradyarrhythmias
6. Hypertrophic cardiomyopathy
7. Patients can not cooperate because of mental impairment or physical disability
8. High-degree AV block
SE-1515 PC ECG User Manual Safety Guidance
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1.3 List of Symbols
No.
Symbol
Description
1
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
2
Caution
3
Operating instructions
4
General symbol for recovery/recyclable
5
Part Number
6
SERIAL NUMBER
7
Date of manufacture
8
MANUFACTURER
9
CLASS II equipment
10
AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY
11
Transmission Status Indicator of Bluetooth
12
Power Supply Indicator of DX12 Receiver
SE-1515 PC ECG User Manual Safety Guidance
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13
Start printing button (on DE15&DE18)
14
CE marking
15
Disposal method
16
Caution: Federal (U.S.) law restricts this device to sale by or on
the order of a physician.
17
Federal Communications Commission:
FCC ID:SMQDX12TREDAN (for DX12 Transmitter)
FCC ID:SMQDX12REEDAN (for DX12 Receiver)
18
Refer to User Manual
(Background: Blue; Symbol: White)
19
Warning
(Background: Yellow; Symbol&Outline: Black)
20
Non- ionizing electromagnetic radiation
21
MR Unsafe–Keep away from magnetic resonance
imaging (MRI) equipment
NOTE: The user manual is printed in black and white.
SE-1515 PC ECG User Manual Introduction
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Chapter 2 Introduction
The SE-1515 system consists of the following equipment:
18-lead ECG sampling system (18-lead ECG sampling box)
Or, 16-lead ECG sampling system (16-lead ECG sampling box)
Or, 12-lead wired ECG sampling system (12-lead ECG sampling box)
Or, 12-lead wireless ECG sampling system (wireless DX12 transmitter and receiver)
PC ECG software
Patient cable
Disposable electrodes
USB cable
According to the configurations of different types of workstations, the following purchased
accessories can also be included: tablet, computer, screen, printer, treadmill/ergometer, and
exercise BP monitor.
NOTE: The pictures and windows in this manual are for reference only.
WARNING
1. Use a special grounded socket to get accurate voltage and current.
2. When using a laptop with a two-prong plug, please connect a grounded printer to avoid
power interference.
3. Only stress BP monitors can be used.
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2.1 Wired SE-1515 System
2.1.1 Wired System Connection Diagram
1. Resting ECG of Wired SE-1515 System
2. Exercise ECG of Wired SE-1515 System
SE-1515 PC ECG User Manual Introduction
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2.1.2 Assembling the Wired System
The DE15 ECG sampling box is used as an example here:
Patient Cable DE15 ECG sampling box
Resting ECG Cable Exercise ECG Cable
Assembly Drawing
1
7
8
6
5
4
2
3
SE-1515 PC ECG User Manual Introduction
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1) Insert plug 1 of the patient cable into socket 2 of DE15 ECG sampling box.
2) Insert plug 7 of the cable into socket 3 of DE15 ECG sampling box.
3) Insert plug 8 of the cable into the USB socket of the PC.
4) Connect plug 6 of the cable to the BP monitor (for exercise ECG only).
5) Connect a treadmill or an ergometer to the PC (for exercise ECG only).
6) Connect a printer to the PC.
7) Insert the Sentinel into the USB socket of the PC if the Sentinel is purchased.
8) Make sure that the above parts are properly connected, and then connect the PC,
treadmill/ergometer and printer to the power supply.
2.1.3 ECG Sampling Box
WARNING
1. When the computer connected to the USB cable is powered on, do not connect the
USB cable to the ECG sampling box; when the system is powered on, do not
disconnect the USB cable from the ECG sampling box.
2. It is not necessary or recommended to regularly disconnect the USB cable from the
ECG sampling box. Disconnect the USB cable from the PC if necessary.
3. When connecting the sampling box to the PC, do not connect them via an USB HUB.
4. When a sampling box is connected the PC, no other device should be connected to the
PC for battery enchargement through an USB cable.
2.1.3.1 DE15/DE18 ECG sampling box
Name
Explanation
Indicator
When the ECG sampling box is powered by the PC, the
indicator will be lit.
USB Interface
Connecting to the USB socket of the PC with a USB cable
USB Interface
Indicator
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2.1.3.2 DP12 ECG Sampling Box
Front Panel
Name
Explanation
Indicator
When the ECG sampling box is powered by the PC, the
indicator will be lit.
USB Interface
Connecting to the USB socket of the PC with a USB cable
2.2 Wireless SE-1515 System
WARNING
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.
NOTE:
1. This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential installation.
This equipment generates, uses 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:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the
Indicator
USB Interface
SE-1515 PC ECG User Manual Introduction
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receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
2. Any changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment.
2.2.1 Wireless System Connection Diagram
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.
SE-1515 PC ECG User Manual Introduction
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1 Resting ECG of Wireless System
2 Exercises ECG of Wireless System
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
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 configurations
shall comply with the valid version of the standard IEC/EN 60601-1. Therefore anybody,
who connects additional equipment to the signal input or output connector to configure
a medical system, must make sure that it complies with the requirements of the valid
version of the system standard IEC/EN 60601-1. If in doubt, consult our technical
SE-1515 PC ECG User Manual Introduction
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service department or your local distributor.
2. The system should be installed by a qualified service engineer. Do not power on the
system until all cables are properly connected and verified.
3. 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.
4. DX12 transmitter of the wireless system uses the Bluetooth technology, which could
make the patient with the pacemaker uncomfortable. Keep DX12 transmitter far away
from the pacemaker when using the wireless system of SE-1515.
2.2.2 Assembling Wireless System
Patient Cable
DX12 Transmitter DX12 Receiver
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Resting ECG Cable Exercise ECG Cable
Burglar Lock DX12 Belt
Assembly
Drawing
1) Insert plug 1 of the patient cable into socket 2 of DX12 transmitter.
2) Insert DX12 transmitter into pocket 3 of DX12 belt, and then wear the belt around the waist.
3) Insert plug 8 of the cable into socket 6 of the DX12 receiver.
4) Insert plug 9 of the cable into the USB socket of the PC.
5) Connect plug 10 of the cable to the BP monitor (for exercise ECG only).
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6) Connect a treadmill or an ergometer to the PC (for exercise ECG only).
7) Connect a printer to the PC.
8) Insert the Sentinel into the USB socket of the PC if the sentinel is purchased.
9) Unlock burglar lock 11 and insert into the burglar lock keyhole of DX12 receiver, and fix the
wireless system via the other end of the burglar lock.
10) Make sure that the above parts are properly connected, and then connect the PC,
treadmill/ergometer and printer to the power supply.
2.2.3 ECG Sampling Box
2.2.3.1 Receiver
2.2.3.2 Transmitter
Button and Symbol
Figure 2-1 DX12 Transmitter Main Screen
USB interface
Keyhole
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Button
Explanation
Switch on DX12 receiver and install batteries on DX12 transmitter. Press the
button to start up DX12 transmitter, the main screen will be displayed..
When the main screen is displayed, press the button to return to previous menu.
When the main screen or the setting screen is displayed, press the button to
enter the next menu.
Press the button first, and press within 1.2s to lock or unlock the
keyboard.
When the main screen is displayed, press the button to switch leads.
When the menu screen is displayed, press the button to display one item in
black.
Bluetooth Connection Icon
If the Bluetooth connection icon is not displayed on the main screen, you
have to match the device manually.
Keyboard Lock Icon
No operation within 8s, the keyboard will be locked automatically and the
main screen is displayed.
Battery Capacity Icon
If the battery in the DX12 transmitter is low, hint will appear in the ECG
station software.
Menu Settings
Make some settings on the DX12 transmitter according to actual use.
Menu
Description
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Back Light
Select On to turn on the backlight of LCD screen.
Select Off to turn off the backlight of LCD screen.
Auto Sleep
Select On to display Sleeping on the screen and make DX12
transmitter be in low power consumption mode after lead off for 5
minutes.
Select Off to turn off auto sleep function.
Language
You can set the system language.
Lead Electrode
You can select IEC or AHA.
Match Device
Inquiring…will be displayed (for 10 seconds) to search DX12
receiver. The address of DX12 receiver will be displayed (for 8
seconds) if a matching DX12 receiver is found. No device found. Try
again later will be displayed (for 1 second) if no matching DX12
receiver is found.
Device
Information
You can see the related information, such as software version, ID,
address of DX12 receiver, manufacture and release time about the
device.
NOTE: The device information is for reference only.
2.3 Installing the Software
2.3.1 Requirements of the PC
CPU
Pentium P4, Celeron D 310 or above
System Memory (RAM)
1G or above
Main Board
Recommend the main board of Intel chipset
Hard Disk
128G or above
Printer
ink jet printer of more than 300dpi or laser printer
Recommend HP2035, HP2010, CANON iP1980
Display
17" TFT (Resolution: 1280*1024, 1366*768), 19" TFT
(resolution: 1440×900), 21" TFT(1920*1080)
Operating System
Windows XP SP3 (32 bit), Windows 7 SP1 (32/64 bit) or
Windows 8 (32/64 bit), Windows 8.1 (32/64 bit), Windows 10
(32/64 bit)
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Complied Standard
IEC/EN 60950
NOTE: Ensure that there is a graphic driver installed in the PC. Otherwise, the displayed
ECG waves may be abnormal.
2.3.2 About Installation Window
Insert the installation CD into CD-ROM, double-click on Setup.exe and then follow the
directions to finish the installation.
For details on installing SE-1515 software, please refer to SE-1515 PC ECG Installation Guide.
2.4 Features
3-/6-/9-/12-/15-/16-/18-channel ECG waves are displayed and printed
ECG waves can be frozen and reviewed
Measurement point adjustment and re-analysis, manual measurement with an electronic
ruler of high precision
High performance filters guarantee stable ECG waveforms
Perfect data management and processing functions
Multiple report formats, including PDF, Word, JPG, and BMP
Supporting multi-language
Supporting auto measurement and diagnosis
Editing the diagnosis templates
The following features are only for the exercise test function
High-performance ECG filter, which ensures wave stability
During sampling, it supports analyzing real-time HR, ST segment and ST trend, and
displays and prints the simultaneous 12-lead ECG in real time.
During sampling, you can perform ST segment analysis on the data of 12 leads, and adjust
the ST segment place involved in lead analysis at any time.
Analyzing arrhythmia automatically
Providing summaries, ST analysis, wave reviews and trends
Providing specific statistic data of each lead in each stage
Providing average waves of each lead in each stage for you to observe the changes of ST
segments among different stages
Automatically generating delicate reports and providing report preview
Providing classical exercise protocols; new exercise protocols can be added to the system
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Storing massive patient data in the computer, which enables you to review and analyze the
exercise ECG in any time
Automatically controlling and adjusting the speed and the elevation of the treadmill
Supporting many kinds of treadmills and ergometers
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Chapter 3 Preparations Before Operation
3.1 Preparing the Patient
NOTE: Correct operation for the best-quality ECG is very important.
3.1.1 Instructing the Patient
1. Before attaching the electrodes, greet the patient and explain the procedure. Explaining the
procedure decreases the patient's anxiety.
2. Privacy is important for relaxation. When possible, prepare the patient in a quiet room or
area where others can't see the patient. Use hangings beside the bed during ECG exam if
other people are in the room.
3. Reassure the patient that the procedure is painless.
4. Make sure that the patient is comfortable.
Once the electrodes and patient cable are connected, inform the patients that:
1) No talking
2) Breathe smoothly
3) Try to be calm
4) Not to chew or keep his teeth firmly
The more relaxed the patient is, the less will the ECG wave is disturbed.
3.1.2 Cleaning the Skin
The skin is a poor conductor of electricity and frequently creates artifacts that distort the ECG
signals. There is natural resistance on the skin surface due to dry, dead epidermal cells, oils and
dirt
To clean the skin
1. Shave hair from electrode sites, if necessary. Excessive hair prevents a good connection.
2. Wash the area thoroughly with soap and water.
3. Dry the skin to increase capillary blood flow and to remove the dead, dry skin cells and oils.
4. Use the disposable frosting film in the standard accessory list to get good ECG waveform.
NOTE: Rub the skin with a gauze pad to increase capillary blood flow if you don't operate
the steps above.
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WARNING
The performance and electric shock protection can be guaranteed only if the original
patient cable and electrodes of the manufacturer are used.
3.2 Connecting the Electrodes of Wired System
DE15 patient cable (Example)
12-Lead Patient Cable (Example)
The patient cable includes patient cable plugs and lead wires which can be connected to
electrodes according to the colors and identifiers. The lead wires have 10 chest leads and 4 limb
leads.
Insert the patient cable plugs to the socket of ECG sampling box.
Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the
corresponding electrodes according to the colors and identifiers.
Connecting to
Electrodes
Lead Wires
Connecting to
ECG
Sampling Box
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3.3 Connecting the Electrodes of Wireless System
Patient Cable (Snap Style)
Patient Cable (Banana Style)
The patient cable includes patient cable plugs and lead wires which can be connected to
electrodes according to the colors and identifiers. The lead wires have 10 chest leads and 4 limb
leads.
Insert the patient cable plugs to the socket of DX12 transmitter.
Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the
corresponding electrodes according to the colors and identifiers.
Connecting to
Electrodes
Lead Wires
Connecting to
ECG Sampling
Box
Main Cable
Main Cable
Lead Wires
Connecting to the
ECG Sampling Box
Connecting to
Electrodes
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3.4 Attaching Electrodes
3.4.1 Attaching Electrodes for Resting ECG
WARNING
Make sure that the conductive parts of electrodes and associated connectors, including
neutral electrodes, do not come in contact with earth or any other conducting objects.
The quality of ECG waveform will be affected by the contact resistance between the patient and
the electrode. In order to get a high-quality ECG, the skin-electrode resistance must be minimized
while connecting electrodes.
The identifiers and color codes of electrodes used comply with IEC/EN requirements. In order to
avoid incorrect connections, the electrode identifiers and color codes are specified in Table 3-1.
Table 3-1 Electrodes and their identifiers and color codes
IEC
AHA
Electrodes
Color Code
Electrodes
Color Code
R
Red
RA
White
L
Yellow
LA
Black
N/RF
Black
RL
Green
F
Green
LL
Red
C1
White/Red
V1
Brown/Red
C2
White/Yellow
V2
Brown/Yellow
C3
White/Green
V3
Brown/Green
C4
White/Brown
V4
Brown/Blue
C5
White/Black
V5
Brown/Orange
C6
White/Violet
V6
Brown/Violet
C3R
White/Pink
V3R
Brown/Yellow
C4R
White/Gray
V4R
Brown/Red
C5R
White/Green
V5R
Brown/Green
C7
White/Orange
V7
Brown/Black
C8
White/Blue
V8
Brown/Blue
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C9
White/Yellow
V9
Brown/Yellow
H
Light blue/Violet/
H
Orange/Violet
E
Light blue/ Yellow
E
Orange/Yellow
I
Light blue/ Red
I
Orange/ Red
M
Light blue/ Black
M
Orange/Black
Standard 12-Lead Placement
Only for the Reusable Electrodes Only for the Disposable Electrodes
IEC
AHA
Electrode Placement
C1
V1
Fourth intercostal space at the right border of the sternum
C2
V2
Fourth intercostal space at the left border of the sternum
C3
V3
Fifth rib between C2 and C4
C4
V4
Fifth intercostal space on the left midclavicular line
C5
V5
Left anterior axillary line at the horizontal level of C4
C6
V6
Left midaxillary line at the horizontal level of C4
L
LA
Left arm/Left deltoid
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R
RA
Right arm/Right deltoid
F
LL
Left leg/Upper leg as close to torso as possible
N
RL
Right leg/Upper leg as close to torso as possible
Standard+XYZ
IEC
AHA
Electrode Placement
C1
V1
Fourth intercostal space at the right border of the sternum
C2
V2
Fourth intercostal space at the left border of the sternum
C3
V3
Fifth rib between C2 and C4
C4
V4
Fifth intercostal space on the left midclavicular line
C5
V5
Left anterior axillary line at the horizontal level of C4
C6
V6
Left midaxillary line at the horizontal level of C4
L
LA
Left arm/Left deltoid
R
RA
Right arm/Right deltoid
F
LL
Left leg/Upper leg as close to torso as possible
N
RL
Right leg/Upper leg as close to torso as possible
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H
H
Back of neck, avoid the carotid artery and jugular vein.
E
E
Mid-sternum on the same horizontal level as C4 and C6.
I
I
Right mid-axillary line on the same horizontal level as C4 and C6.
M
M
Center of spine on the same horizontal level as C4 and C6
Frank Lead Placement (for VCG)
IEC
AHA
Electrode Placement
C1
(Corresponding to I)
V1
(Corresponding to I)
Right mid-axillary line on the same horizontal
level as C3 and C4
C2
(Corresponding to E)
V2
(Corresponding to E)
Sternum at the level of C3 and C4
C3
(Corresponding to C)
V3
(Corresponding to C)
Mid-clavicular line in the fifth intercostals
space
C4
(Corresponding to A)
V4
(Corresponding to A)
Left mid-axilary line on the same horizontal
level as C3
C5
(Corresponding to M)
V5
(Corresponding to M)
Center of spine on the same horizontal level
as C3 and C4
C6
(Corresponding to H)
V6
(Corresponding to H)
Neck, avoid carotid artery and jugular vein
L
LA
Left arm/Left deltoid
R
RA
Right arm/Right deltoid
F
LL
Left leg/Upper leg as close to torso as
possible
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N
RL
Right leg/Upper leg as close to torso as
possible
NEHB Placement
IEC
AHA
Electrode Placement
Nst/C3R
A1/V3R
Attachment point of the second rib to the right sternal edge
Nax/C4R
A2/V4R
Fifth intercostal space on the left posterior axillary line
Nap/C4
V4
Left mid-clavicular line in the fifth intercostal space
V3R+V4R +V5R (Right)
IEC
AHA
Electrode Placement
C3R
V3R
Right anterior chest opposite of C3
C4R
V4R
Right anterior chest opposite of C4
C5R
V5R
Right anterior chest opposite of C5
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V7+V8+V9 (Back)
DE18:
IEC
AHA
Electrode Placement
C7
V7
Left posterior axillary line on the same horizontal level as C4 and C6
C8
V8
Left midscapular line on the same horizontal level as C4 and C7
C9
V9
Left paraspinal border on the same horizontal level as C4 and C8
DE15:
IEC
AHA
Electrode Placement
C7
V7
Left posterior axillary line on the same horizontal level as C4 and C6
C8/V5R
V8/V5R
Left midscapular line on the same horizontal level as C4 and C7
C9/V4R
V9/V4R
Left paraspinal border on the same horizontal level as C4 and C8
3.4.2 Electrode Placement for Exercise ECG
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The Precordial Electrodes' Positions on Body Surface:
IEC
AHA
Electrode Placement
C1
V1
Fourth intercostal space at the right border of the sternum
C2
V2
Fourth intercostal space at the left border of the sternum
C3
V3
Fifth rib between C2 and C4
C4
V4
Fifth intercostal space on the left midclavicular line
C5
V5
Left anterior axillary line at the horizontal level of C4
C6
V6
Left midaxillary line at the horizontal level of C4
The Extremity Electrodes' Positions on Body Surface:
IEC
AHA
Electrode Placement
R / L
RA / LA
Below the right/left clavicle
N / F
RL / LL
Below the right/left rib
3.4.3 Attaching the Reusable Electrodes
3.4.3.1 Attaching the Limb Electrodes
Limb Electrode
Limb Electrode Connection:
1) Ensure that the electrodes are clean;
2) Clean the electrode area which is a short distance above
the ankle or the wrist with 75% alcohol;
3) Daub the electrode area on the limb with gel evenly;
4) Place a small amount of gel on the metal part of the
limb electrode clamp;
5) Connect the electrode to the limb, and make sure that
the metal part is placed on the electrode area above the
ankle or the wrist;
6) Attach all limb electrodes in the same way.
Reed
Connecting to a Lead Wire
Clamp
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3.4.3.2 Attaching the Chest Electrodes
Chest Electrode
Chest Electrode Connection:
1) Ensure that the electrodes are clean;
2) Clean the electrode area on the chest surface with 75% alcohol;
3) Daub the round area of 25mm in diameter on each electrode site with gel evenly;
4) Place a small amount of gel on the brim of the chest electrode's metal cup;
5) Place the electrode on the chest electrode site and squeeze the suction bulb. Unclench it and
the electrode is adsorbed on the chest;
6) Attach all chest electrodes in the same way.
NOTE: Long-time measurement with a strong negative pressure on the suction bulb may
cause reddening of the skin. When using the electrode on kids or patients with
delicate skin, squeeze the suction bulb lightly.
3.4.4 Attaching Disposable Electrodes
Disposable Electrode (clip style): Alligator Clip:
Disposable Electrode Connection (Clip Style)
1) Align all lead wires of the patient cable to avoid twisting, and connect the alligator clips to
the patient cable.
Suction Bulb
Connecting to a Lead Wire
Metal Cup
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2) Clean the electrode areas on the body surface with 75% alcohol.
3) Attach the disposable electrodes to the electrode positions on the body surface.
4) Clip the disposable electrodes with the alligator clips.
Snap/Banana Socket Adapters Disposable Electrode (Snap Style)
Disposable Electrode Connection (Snap Style)
1) Align all lead wires of the patient cable to avoid twisting, and cnnect Snap/Banana
Socket Adapters to connector of patient cable.
2) Clean the electrode areas on the body surface with 75% alcohol.
3) Attach the disposable electrodes to the electrode positions on the body surface.
4) Connect Snap/Banana Socket Adapters to the disposable electrodes.
WARNING
1. The disposable electrodes can only be used for one time.
2. The clip electrodes should be used together with the alligator clips.
3.5 Inspection Before Test
In order to avoid safety hazards and get good ECG records, the following inspection procedure is
recommended before operation.
1) Environment:
Make sure that there is no electromagnetic interference source around the equipment,
especially large medical electrical equipment such as electrosurgical equipment,
radiological equipment, magnetic resonance imaging equipment etc. Switch off these
devices when necessary.
Keep the examination room warm (above 18℃) to avoid muscle action voltages in
ECG signals caused by cold.
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2) Power Supply:
Check whether the power cord is connected well. The grounded outlet should be used.
3) Ground Connection
Check whether the ground cable is firmly connected.
4) Patient Cable:
Check whether the patient cable is connected to the ECG sampling box firmly, and keep it
far away from the power cord.
5) Electrodes:
♦ Check whether all electrodes are connected to lead wires of the patient cable correctly.
♦ Ensure that the electrodes do not contact.
6) Patient:
♦ The patient should not come into contact with conducting objects such as earth, metal
parts etc.
♦ Ensure the patient is warm and relaxed, and breathes calmly.
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Chapter 4 ECG Sampling
Plug in the right sentinel, and double-click on the screen to start the software. The main
screen will be displayed as follows:
Figure 4-1 Main screen
4.1 Initial Configuration
When the software is started the first time after installation, an Initial Setting window will be
displayed, and you can configure parameters such as the hospital name, lead mode, and sequence.
NOTE: If you need to reinstall the software, reinstall it under the original directory.
Otherwise, you will have to reconfigure it.
4.2 Entering Patient Information
You can enter the patient information with the following two ways:
1. New Patient
Click New Patient on the main screen (Figure 4-1), and the New Patient window will be
displayed as follows:
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Figure 4-2 New Patient window
You can also enter the New Patient window by clicking New Patient on the analysis screen.
2. New Order
On the Archives screen, click Order List, and you enter patient information in the New
Order area.
NOTE: The Order List is not displayed in the Archives screen by default. You have to
select Display Order List in the Basic Setting window of System Setting.
4.2.1 Entering Patient Information Manually
NOTE: Customize_1/2 can be customized in the Basic Information window; pacemaker
and other patient information options can be configured in the Display Setting
window. Before the configuration is complete, these options won't be displayed in
the New Patient window. For details, see section 8.1.1 and 8.2.
Enter basic information:
You can fill out the basic information of a patient.
If Pacemaker is selected on the Display Setting window, a checkbox for the pacemaker will be
provided on the New Patient window. If Pacemaker is selected, SE-1515 is very sensitive and
can detect very small pacemaker pulses. Therefore, SE-1515 should be placed far from the
devices emitting high frequency radiation to avoid interferences on the pacemaker pulse detection
and normal ECG acquisition.
NOTE:
1. In the New Patient window, patient ID is a must. You can use the number generated
by the system or input a number manually. Patient ID can be a random character
string excluding '/', '\', ':', '*', '?', '<', '>' and '|'.
2. Select Pacemaker only when the system is mostly used for patients with
pacemakers.
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4.2.2 Entering Patient Information by Using a Bar Code Reader
The procedure is as follows:
1. Configure the bar code
For more detailed information about configuring the bar code, please contact the
manufacturer or the local distributor.
NOTE: If the two-dimensional bar code reader is used, you should install Symbol
COM Port Emulation Driver manually. For details, please refer to SE-1515 PC
ECG Installation Guide.
2. Connect the USB bar code reader to the computer.
3. Start the SE-1515 PC ECG software.
4. Use the barcode reader to scan the code:
One-dimensional: Place the cursor on the Patient ID in the New Patient window or order
screen and then scan the barcode.
Two-dimensional: On the Archives screen, scan the barcode and the New Patient window
will be displayed with the patient information filled out automatically; or place the cursor on
the patient ID in the New Patient window before scanning.
NOTE:
1. Only the USB bar code reader recommended by the manufacturer can be used.
2. The USB bar code reader can only read the basic patient information.
4.2.3 Retrieve Patient Information
On the Archives screen, you can use the following two methods to retrieve the information of a
patient recorded before:
Select an order record and click Exam.; or select an examination record, and click Retrieve.
4.3 Selecting the ECG Sampling Type
When creating a new patient record, you can configure the ECG sampling type in the New
Patient window.
When placing a new order, you can select the ECG sampling type in the New Order area.
Options provided are Resting ECG, Exercise ECG, VCG/SAECG, and HRV.
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4.4 ECG Sampling
4.4.1 Resting ECG Sampling
Click on OK after filling out the patient information and selecting the ECG sampling type, the
ECG sampling screen will be displayed.
NOTE: When placing a new order, if you want to start ECG sampling right after placing
the order, select Start examination after order in the Display Setting of
System Setting.
Figure 4-3 Resting ECG Sampling
4.4.1.1 Buttons
NOTE:
1. You can directly press F1, F4 and F5 on the keyboard to control the ECG
sampling screen.
2. The Stop, Keep, and Comment buttons can be used only after the Start button
is pressed.
Button
Description
Start
F1
Once clicked, the system starts sampling and automatically saves the sampled
ECG data to the specified directory.
Stop
F4
Once clicked, the system stops ECG sampling.
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Edit
Once clicked, the New Patient window will be displayed and you can edit the
patient information.
Freeze
Once clicked, the frozen window will be displayed.
On the displayed window, you can review the ECG sampled before, and print
the displayed ECG by clicking on the Print button.
Keep
If this button has been clicked, the system continues the sampling when the
sampling time extends the preset time.
During the extended sampling, you can click Stop at any time to stop the
sampling process, or cancel Keep and finish sampling within the preset time.
Event
F5
If this button is clicked, you can mark the sampled waveforms at any time. After
the sampling process is complete, you can find the corresponding waveforms
with the event marks on the rhythm wave screen. The marked waveforms are
stressed with yellow lines.
Settings
If this button is clicked, you can configure the parameters provided on the
displayed window.
4.4.1.2 Signal Strength Indication
At the bottom right corner of the ECG sampling screen, a signal strength indication model is
displayed.
You can check the placement of each lead according to the signal strength indication model, and
identify the signal strength of each electrode based on the background color.
Electrode
indication color
Green: The waveforms are good and are free from interferences.
Yellow: The waveforms are interfered.
Red: The lead is off.
Indication
AAA: Noise type.
BX: Lead
For example, AAA: B1, B2, B3 means that the EMG interferences on
lead I, II, and V1 are serious.
4.4.1.3 Display Mode Setup
You can configure the display mode, gain, paper speed, filter, lead sequence, and lead mode.
Rhythm 1 and Rhythm 3 can be selected for display mode.
The lead order is related to the lead mode. Different lead modes have different lead sequences.
NOTE: To pass the distortion test, the ECG workstation has to be configured with the
highest bandwidth in filter settings. Otherwise, ECG signal may be distorted.
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4.4.1.4 Sample Setup
Click on Setting on the resting ECG sampling screen, and the System Setting window will be
displayed. In the System Setting window, click Sampling Setting to enter the Sampling Setting
window.
Parameter
Description
Device Type
Options provided are DP12, DX12, DE15, SE12, DE18, and DEMO.
If DX12 is selected, you can view the address of the DX12 wireless receiver
after clicking on Receiver Address.
Device Port
You can configure the COM ports used for transmission.
Device ID
You can configure the Device ID. The device number must be within 30
characters.
WARNING
The device number cannot be changed. Contact the manufacturer if you want to make
any modifications on it.
Sampling time
You can configure the sampling time for resting ECG.
Lead mode
Options provided are 9-lead, 12-lead, 15-lead, 16-lead, and 18-lead
The 9-lead mode is normally used for pediatric ECG or physical examination.
Lead sequence
Under the 9-lead mode, you can choose Physical mode.
Lead Sequence
Lead Group
Physical mode
І, II, ІІІ, aVR, aVL, aVF, V1, V3, V5
Under the 12-lead mode, you can choose from Standard and Cabrera.
Lead Sequence
Lead Group
Sadard
І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
Crera
aVL, І, -aVR, II, aVF, ІІІ, V1, V2, V3, V4, V5, V6
Under the 15-lead mode, you can choose from Standard+Right, Standard+Back,
Standard+NEHB, Standard+XYZ, and Children mode.
Lead Sequence
Lead Group
Standard+Right
І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R,
V4R, V5R
Standad+ak
І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7,
V8, V9
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Standard+NEHB
І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, ND,
NA, NI
Standard+XYZ
І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, X, Y,
Z
Children mode
І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R,
V4R, V7
Under the 16-lead mode, you can choose Standard+Right.
Lead Sequence
Lead Group
Standard+Right
І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R,
V4R, V5R, V7
Under the 18-lead mode, you can choose Standard+Right+Back.
Lead Squence
Lead Group
Standard+Right+Back
І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5,
V6, V3R, V4R, V5R, V7, V8, V9
Lead electrode
Options provided are IEC and AHA.
You can configure it based on the patient cable used.
Display Order
Options provided are Simultaneously and Continuously.
If continuously is selected, the lead group will be displayed group by group.
If simultaneously is selected, all the leads will be displayed at the same time.
QRS Sound
Options provided are ON and OFF.
AC Filter
It is used to protect on the ECG signals from the interferences of the AC power.
Options provided are OFF, 50Hz, and 60Hz.
Select 50Hz/60Hz, AC50/AC60 will be printed on the report respectively.
DFT Filter
It is used to ensure that the ECG signals are on the same level during sampling.
The value configured for DFT filter will be printed on the report.
Auto
Diagnosis
Options provided are Display Standards, Display Normal ECG only, Display
All and OFF.
If Display Standards is selected, the system generates the automatic diagnosis
result after the sampling is complete.
If Display Normal ECG only is selected, the system only generates the
diagnosis result for the normal ECG after the sampling is complete.
If Display All is selected, the system generates automatic diagnosis results for
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all analysis screens.
If OFF is selected, the system does not generate any automatic diagnosis results
after the sampling is complete.
Enter the
analysis screen
when sampling
finishes
If this function is selected, the system automatically switches to the analysis
screen after the sampling is complete.
Auto print
when sampling
finishes
If this function is selected, the system automatically prints the report after the
sampling is complete.
4.4.1.5 Print Setup
Click on Setting on the resting ECG sampling screen, and the System Setting window will be
displayed. In the System Setting window, click Print Setting to enter the Print Setting window.
Item
Description
Report Setting
You can configure the information to be displayed on the print preview
screen and the report to be printed.
The options provided are: Normal ECG Report, Detailed Report,
Template Report, Rhythm Wave Report, and VCG Report.
If Template Report is selected, the Feature Point Location option will be
displayed. When Feature Point Location is selected, 5 measurement lines
will appear on the average template waveforms. However, this only applies
to the average template report for resting ECG.
VCG Report is available only when Enable Vector Calculation is
selected in the Function/Algorithm Setting window.
If VCG Report is selected, the option XYZ Wave will appear.
Current Template
Three templates are provided by default and cannot be deleted. However,
you can edit the default templates and save them as new templates.
Rhythm Lead
You can set Rhythm 1, Rhythm 2, and Rhythm 3 to any one of the leads
in the current lead mode.
Wave Width,
Grid Width
You can set grid (1mm) and grid (5mm)to 1, 2, 3, 4, 5, or No
respectively.
A larger value means that the grid printed is wider.
When No is selected, no grid will be printed.
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The wave width can be set to 1, 2, 3, 4, or 5.
A larger value means that the waveforms printed are wider.
NOTE: This parameter affects the printing only, the waveforms
displayed on the screen remains the same.
Print Setting
Sequence can be set to sequential or synchronous.
If sequential is selected, the lead group will be sampled group by
group.
If synchronous is selected, all the leads will be sampled at the
same time.
Paper Orientation can be set to Landscape or Portrait.
Paper Size can be set to A4 or Letter.
Baseline Adjustment can be set to OFF, Auto, or Horizontal.
If it is set to Horizontal, the baseline for leads on the same level is
in the same line.
If it is set to Auto, the system automatically adjusts the baseline
for each lead group.
If it is set to OFF, the system adjusts the baseline for each lead
group to an average value.
If Auto Gain Control (AGC) is selected, the gain will be adjusted
automatically, and the Baseline Adjustment is set to Horizontal
automatically.
If the printing color is set to color, the background grid will be printed
in color.
NOTE: If the printing color is set to color, but a black-and-white
printer is used, the report printed will be illegible.
If Print after diagnosis is selected, the system automatically prints the
report after the diagnosis is complete.
4.4.1.6 Function/Algorithm Setup
Click on Setting on the resting ECG sampling screen, and the System Setting window will be
displayed. In the System Setting window, click Function/Algorithm Setting to enter the
Function/Algorithm Setting screen.
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Parameter
Description
Enable Vector
Calculation
Once enabled, you can view the vector calculation results on the analysis
screen for resting ECG.
NOTE: This function is unavailable in 9-Lead mode and
Standard+XYZ mode..
Parameter
Setting
Axis Calculation Method can be set to Area Method or Amplitude
Method.
Tachycardia Criterion (greater than): Manual input, default: 100
bpm.
When the patient's heart rate exceeds the Tachycardia Criterion, a
Tachycardia hint will appear in the diagnosis result, and the HR
information will be stressed with red.
Bradycardia Criterion (less than) : Manual input, default: 60 bpm
ECG key
Options provided are Start and Forbidden.
When Start is selected, the ECG key on the DE15/DE18 sampling box
functions as the Start button on the ECG sampling Screen.
When Forbidden is selected, there will be no response when pressing the
ECG key.
4.4.1.7 Other Setup
Click on Setting on the resting ECG sampling screen, and the System Setting window will be
displayed. In the System Setting window, click Others to enter the Others screen.
Item
Description
Display
When Anti-aliasing is selected, the waveforms displayed or printed will
be smoother.
When 1mV marker is enabled, the 1mV calibration mark will be
displayed at the start of a line of waveforms in the sampling screen or
analysis screen.
Grid View can be set to:
5mm: Only the 5mm grid is dispplayed on the waveform screens.
The 1mm grid will not be displayed.
1mm: Both 5mm grid and 1mm grid will be displayed on the
waveform screens.
1s/1mV: On the waveform screens, 1s is regarded as a grid (5mm)
horizontally, and 1mV is regarded as a grid (5mm) vertically.
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No: No grid will be displayed on the waveform screens.
Arrhythmia hint, can be set to On or OFF.
If it is set to On, when arrhthmia data is sampled during the sampling
process, the system will highlight the related waveforms and provides
the arrhthmia type.
Printer type
You can select a type of printers in the operating system.
Comment when
marking an event
When this function is selected, you can add a mark on an event.
4.4.2 STAT ECG
Click on STAT ECG on the main screen and you can enter the sampling screen for resting ECG
directly. The system automatically generates a patient ID.
NOTE: The difference between the resting ECG sampling and STAT ECG sampling is
that, during resting ECG sampling, you have to configure information for a new
patient or use the information of an existing patient.
All operations for the STAT ECG are the same as those for the resting ECG data sampling.
4.4.3 Exercise ECG Sampling
NOTE: The exercise test duration of SE-1515 can be as long as 2 hours. Normally, the
test duration is within 40 minutes.
Figure 4-4 Exercise ECG sampling window
You can configure the display mode, print mode, paper speed, gain, and filter in
.
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4.4.3.1 Buttons
NOTE:
1. You can use F1–F9 on the keyboard directly to control the ECG sampling screen.
2. No matter how many changes on the speed or slope you make in a stage, the
software only saves the latest one.
Button
Description
Pretest
F1
On the presampling screen, you can click Pretest to enter the pretest stage.
On the sampling screen, you can click Pretest to move into the next pretest
stage.
Exercise
F2
In the Pretest stage you can click Exercise to move into the exercise stage.
In the Exercise stage, you can click Exercise to move into the next exercise
stage.
NOTE: This function cannot be used when the sampling has been in
the last Exercise stage.
Recovery
F3
In the Exercise stage, you can click Recovery to move into the Recovery
stage.
In the Recovery stage, you can click Recovery to move into the next
Recovery stage.
NOTE: This function cannot be used when the test in the last Recovery
stage.
Stop
F4
Once Stop is clicked, the system stops sampling and refreshes the waveforms,
and displays a window.
In the displayed window, you can select or manually input the reason for test
termination. The reason input manually will be saved as an option for the next
time.
Print/Setting
F5
In the presampling stage, Setting is displayed.
Click Setting and the Setting window will be displayed. You can
configure the related parameters in this window.
NOTE: The Sample Setting, Print Setting, and Others windows
for the exercise ECG are the same as those for the resting
ECG. For details, see section 4.4.1.4, section 4.4.1.5, and
section 4.4.1.7.
During the test, Print is displayed.
Click Print and the system will print the 12-lead waveform report in the
last 10s. If the paper used can only be printed with the an ECG of Xs
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(X<10), the system will print the waveforms in the last Xs.
Freeze
F6
During the presampling stage and test, Freeze is displayed. Click Freeze and
the frozen window will be displayed.
Edit/Event
F7
During presampling, you can click Edit to open the New Patient window
and edit patient information.
During the test, Event is displayed. You can click it to mark an event.
BP
F8
Click BP in the auto measurement mode, the system will activate the BP
monitor and start measuring.
Click BP in the manual measurement mode, you can manually input BP in the
displayed window.
Start/Stop Tmill
F9
Only available in the Exercise and Recovery stage.
During the exercise test, you can click Stop Tmill to cool down the treadmill
and stop the exercise test temporarily, and click Start Tmill to continue the
exercise test.
Keep
Click Keep during the exercise test, and the system will maintain the current
speed and slope before you click Keep again.
NOTE: In the Keep status, the test cannot move into the next stage
automatically.
Next
Click Next during the exercise test and the system will move into a new stage.
NOTE: When the Pretest has lasted for less than 15s, you cannot click
Next to move from the Pretest to Exercise.
Speed Up/Speed
Down
You can click Speed Up/Speed Down in the Exercise stage to raise/reduce
the speed of the treadmill.
You can click Speed Up/Speed Down in the Exercise stage to raise/reduce
the output of the ergometer.
Slope Up/Slope
Down
You can click Slope Up/Slope Down in the Exercise stage to raise/reduce the
slope of the treadmill.
Exercise
Amount
Up/Down
You can click Exercise Amount Up/Down in the Exercise stage to
add/reduce 5W exercise amount at one time.
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4.4.3.2 Parameter Information Display
Heart rate display
NOTE:
1. If the background color of the current HR displayed is yellow, it indicates that the
current HR excesses the target value and should be paid attention to.
2. If the current HR excesses the target value, you should click Recovery to move
into the Recovery stage and observe the waveforms of in that stage.
BP display
When a BP monitor is connected to the system, the blood pressure display area is as follows:
The blood pressure data automatically refreshes regularly according to the configured blood
pressure sampling mode. You can click BP to manually refresh to the blood pressure.
The normal BP range can be configured in the Setting screen of the exercise ECG.
NOTE: If the background color of the blood pressure display area is yellow, it indicates
that the current systolic or diastolic is abnormal.
Information display area
If a treadmill is used, the information display area displays the total time, protocol, stage time,
stage, speed, slope, PVC/min, Max ST and Min ST, etc.
If an ergometer is used, the information display area displays the total time, protocol, stage time,
stage, exercise amount, PVC/min, Max ST and Min ST, etc.
4.4.3.3 Average Template
On the sampling screen for exercise ECG, you can click on Amplify or Template to observe the
average template of one or multiple waveforms.
The ST value and ST slope, displayed on the mean wave of each lead, refreshes every 10s. The 3
measurement lines on each mean wave shifts with that of the waveform simultaneously.
You can change the POSTj and the place of the measurement line to adjust the current ST and ST
slope for each lead. However, you cannot change the POSTj and the place of the measurement
line of the baseline ST.
Current HR
Target HR
Percentage of the current
HR against the target HR
Systolic
Diastolic
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When you click Re-identify after you have manually adjusted the measurement line, the system
automatically calculates the place of the measurement line of the Q point and J point and their
corresponding ST value and ST slope. The system also refreshes the place of the measurement
line of the Q point and J point every 10s.
1. single amplified mean wave
You can manage the lead to be displayed by system scan or manual configuration.
2. multiple original mean waves
In the manual mode, double-click on any mean wave area and the system will automatically
switch to its enlarged display window.
3. ST baseline
Right-click on the area of a single amplified mean wave or multiple original mean waves and
the system will display the Accumulate Baseline/Accumulate All.
Select the Accumulate Baseline and the baseline mean wave will be folded up to the
average template of each lead. This operation is only available during the Exercise stage.
Select the Accumulate All and the mean wave of all leads will be folded up on the
single amplified mean wave window.
4.4.3.4 ST Trend
On the ST Trend screen, the ST run charts of 6 leads are displayed. You can right-click to switch
between lead groups.
4.4.3.5 Sample Setup
Click on Settings on the exercise ECG sampling screen, and the System Setting window will be
displayed. In the System Setting window, click Sample Setting to enter the Sample Setting
window.
In the Sampling Setting window, you can
Configure the model, port number, device ID of the sampling box.
Configure the parameters of the filter.
Configure the lead mode, lead sequence, lead electrode, display sequence and QRS voice.
In addition, the lead sequence can be edited.
Select the Enter the analysis screen when sampling finishes.
Select the Auto print when sampling finishes.
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4.4.3.6 Device Setup
Click on Settings on the exercise ECG sampling screen, and the System Setting window will be
displayed. In the System Setting window, click Device to enter the Device window.
Parameter
Description
Device Type
Options provided are Treadmill or Ergometer.
Device Model
You can configure the device model based on the device used.
If RUNNER RUN-2011/T treadmill is to be used, set the Device Model
to Trackmaster Treadmill.
Protocol
You can configure the protocol based on the device used or customize a
protocol.
You can click Edit to edit the protocol. For details, see section 4.5.3.7.
You can click Restore to factory defaults and the system will to reset
the protocols to the default value.
BP monitor
You can set BP monitor to the port that can be used on the computer.
BP Sampling Mode
Options provided are:
Once per stage
The system starts measuring the blood pressure immediately after
entering a new stage each time. However, in the Pretest stage, the
system only starts the blood pressure measurement in the first 10s of
the first stage.
Once every three/five/seven minutes
After the first time the blood pressure is measured in the pretest
stage, that is, the first 10s of the first stage, the system starts the
measurement every 3/5/7 minutes.
Protocol-Based Control
The blood pressure measurement starts as configured in the
Protocol Edit screen.
Manual Input
You have to input the blood pressure data manually.
Triggering mode
It can be set to Square wave or QRS.
Unit
The unit of Speed can be set to mph or km/h.
The unit of Slope can be set to % or degree.
ECG Key
It can be set to Pretest, Print, or Forbidden.
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4.4.3.7 Protocol Editing
In the Device window, select a protocol and click Edit to enter the editing window for
non-default protocols. In this window, you can change any parameter of each stage or delete the
non-default protocols.
4.4.3.8 Parameter Setup
Item
Description
Target HR
You can configure the Max predicted HR and the calculation method of
the target HR.
Normal BP range
You can configure the systolic and diastolic to the value in the normal
range.
If the blood pressure of the patient excesses the configured value, an
indication message will be displayed on the main screen and the
background color of the blood pressure parameter will be yellow.
POST J
It can be set to Manual or Auto.
NOTE: J point is the endpoint of the QRS waveform group and
the startpoint of the ST segment. It is also the reference
point used by the system to determine the place of the
ST segment. Please select the J point based on the
actual ECG waveforms of the patient.
ST Standards
When ST Overrun hint is selected, the system will display an
indication message ST Overrun when the ST value is detected to be
beyond the threshold.
You can set the threshold for ST Elevation or ST Depression only
after STOverrun hint is selected.
ST Elevation can be set to 0.05 ~0.3mV, and ST Depression can be set
to -0.05 ~-0.3mV.
Manual Report
Options provided are Print, Print and Save, Save.
When Print/Print and Save/Save is selected, you can click Print to
Print/Print and Save/Save the corresponding ECG report during the
exercise test.
Auto Report
Options provided are OFF, Print, Print and Save, Save.
If OFF is selected, the 12-lead report will not be printed automatically
on the scheduled auto-print time (configured on the Edit Protocol
window) during the exercise test.
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If Print/Print and Save/Save is selected, the 12-lead report of the
Exercise stage will be Print/Print and Save/Save.
Event Report
Options provided are OFF, Print, Print and Save, Save.
If OFF is selected, the system will not print or save the event marker
report during the exercise test, but it will save the event marker report
to the summary and analysis screen.
If Print/Print and Save/Save is selected, the system automatically
print/print and save/save the 12-lead report with comment.
Arrhythmia Report
Options provided are OFF, Print, Print and Save, Save.
If OFF is selected, the system will not print or save the arrhythmia
report during the exercise test.
If Print/Print and Save/Save is selected, the system automatically
Print/Print and Save/Save the arrhythmia report.
ECG-Report-ST/ECG
-Report-Analysis/Duk
e Score/FAI%
If ECG Report-ST, ECG Report-Analysis, Duke Score or FAI% is
selected, corresponding information will be contained in the printed
report.
4.4.4 VCG Sampling
Buttons
Similar to those of resting ECG. For details, refer to section 4.4.1 "Buttons".
Sampling
Setting
Auto Diagnosis
Options: Display Standard and Off.
For details about other parameters, refer to section 4.4.1.4 "Sample Setup".
Print Setting
Report Setting
Options: VCG Report, XYZ Wave
TVCG Report and SAECG Report are reserved
functions, and are not supported currently.
Rhythm Lead
Select the lead to be analyzed in the VCG mode.
For details about other parameters, refer to section 4.4.1.5 "Print Setup".
Other Setting
For details about other parameters, refer to section 4.4.1.7 "Other Setup".
4.4.5 HRV ECG Sampling
In the HRV ECG sampling mode, the default sampling time is 5 minutes.
For details about operations and parameter settings, refer to section 4.4.1 "Resting ECG
Sampling".
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Chapter 5 ECG Analysis
Three methods can be used to enter the ECG analysis screen:
1. When the ECG sampling time has met the planed value, the system automatically stop ECG
sampling and enters the ECG analysis screen.
2. Click Stop on the sampling screen, the system will automatically displays the analysis screen.
3. In the patient record area on the All List screen, double-click on a record to enter the analysis
screen.
When Resting ECG is selected, the ECG analysis screen contains the resting ECG, rhythm ECG,
and pharma study ECG.
5.1 Resting ECG
5.1.1 Wave Analysis
Click Waveform to enter the Waveform screen for resting ECG. On this screen, you can
configure the paper speed, gain, display format, and display order.
Figure 5-1 Resting ECG–Waveform screen
1. Click Re-sample and you can resample ECG data on the ECG sampling screen. After
resampling, you can click Comparison to analyze the comparison results of the two sampled
ECG records.
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2. Click Pharma to open the pharma study screen start pharma study.
Test Time Setting
In the parameter setup window for pharma study, you can set the report output time
mode. The default value is 0-1-3-5-10-15. It means the system will automatically output
a report in the beginning, 1st, 3rd, 5th, 10th, and 15th minute. This function is available
only when the report format for pharma study is set to All-Lead ECG Report.
You can also customize new time modes. A new time mode can contain a maximum of
10 time nodes and the time node value must be no larger than 30. When the cusmization
is started, you should set the time nodes first and then close the customization window.
For details about other settings, refer to corresponding parameter descriptions for resting
ECG.
3. If you find the hand electrodes or chest electrodes have been placed incorrectly after ECG
sampling, you can click Inversion to adjust the electrode settings and therefore avoid
resampling.
4. Click Re-analyze and the system automatically reanalyze the ECG data in the last 10s.
5. The information displayed on the right panel includes measurement information, feature
description and diagnosis result.
Measurement information: Parameter values can be input manually. If the value is
beyond range, it will turn red automatically.
Shortcut Keyboard: Used for quick modification on feature description or diagnosis
result.
Smart input: In the Feature Description or Diagnosis Result area, you can input only
one letter and possible phrases will be provided.
Glossary: Click to open the Glossary window and you can edit feature description or
diagnosis result.
History: Click on History and you can view all the history diagnosis records of the
current patient.
6. Right-click on the waveform area and a shortcut menu will be displayed. Options provided
are R-R (bpm), R-R (ms) and Refilter.
Select R-R (bpm)/ R-R (ms) and related data will be displayed.
Select Refilter and you can modify the parameter values in the Refilter window.
7. Double-click on the waveform area, you can view the magnified waveform around the click
point on the magnified waveform screen.
Click on the lead symbol in the 1mV calibration mark and you can switch leads.
The inverted triangles correspond to R waves. Click on an inverted triangle, 5 mark lines
will appear around the corresponding R wave and related R, QRS, PR, and QT/QTC
information will be displayed. Right click and you can disable the mark lines.
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On the magnified waveform screen, drag the mouse and an electronic measurement ruler
(hereinafter called ruler) and corresponding measurement data will be displayed. You
can move the ruler by pressing Up/Down/Left/Right arrow keys.
NOTE: The mark line and ruler cannot be used at the same time, please right
-click to disable either of them first. To enable it, right-click again.
8. VCG:
If Enable Vector Calculation is selected in the Function/Algorithm Settings window, you
can click VCG for vector calculation on the resting ECG analysis screen. For details, refer to
section 5.3 "VCG".
5.1.2 Average Template
Click Template to enter the Average Template window for resting ECG. In this window, you can
analyze the data of waveforms on the Average Template.
When you press ALL, magnified average templates of all leads will be overlapped with the
same central axis.
You can set the speed and the gain of average templates.
You can drag marker lines of P1, P2, Q, S and T on average templates.
P1 is the onset of P wave, P2 is the offset of P wave, Q marks the onset of the QRS wave, S
marks the offset of the QRS wave, and T is the offset of the T wave. You can move these
lines by dragging on the mouse and the corresponding parameter values will change. You can
also use the arrows key on the keyboard to move these marks.
Reset
After you manually modify the position of a marker line, you can click Reset to restore it to
the initial position. The ST and ST slope will be automatically updated at the same time.
Re-diagnose
After you manually modify the position of a marker line, the diagnosis result which is based
on the marker line position and corresponding measurement information will not update
automatically, you have to click Re-diagnose to update to update the diagnosis result.
5.1.3 About the Detail Information Window
On the Average Template window for resting ECG, click on Detail Information at the bottom
left corner to enter the Detail Information screen.
You can click Export Excel to export an Excel file.
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5.1.4 About the Rhythm Wave Window
Click on Rhythm to enter the Rhythm screen. On this screen, you can view the rhythm waves.
Item
Description
Event Review
Click to view the strips about arrhythmia and strips saved when marking
an event.
5.1.5 History Record
On the analysis screen for resting ECG, click History and the History Record window will be displayed. You
can view all the history records of the current user.
Information displayed on the History Record window includes Exam. ID, Exam. Time, Exam. Type, Exam.
Status, and Diagnosis Result. Click on a record and you can view the related information on the analysis
screen displayed.
5.1.6 About the Parameters
On the analysis screen for resting ECG, if you made any modifications to the parameters, click
Save to save the modifications.
Common parameters used are listed in the following table:
Designation
Description
HR
Heart Rate
P
P-wave duration
PR
P-R interval
QRS
QRS complex duration
QT/QTc
Q-T interval/Corrected QT interval
P/QRS/T
The electric axis of P/QRS/T wave.
RV5/SV1
The amplitude of R wave of V5 lead/the amplitude of S wave of V1 lead
RV5+SV1
The amplitude of R wave of V5 lead plus the amplitude of S wave of V1
lead
RV6/SV2
The amplitude of R wave of V6 lead/the amplitude of S wave of V2 lead
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5.2 Exercise ECG
5.2.1 About the Summary Screen
5.2.1.1 Stage Information
The stage information includes:
1. Stage information list:
If a treadmill is used, you can view the information such as stage, stage time, speed,
slope, Workload, BP, PVC/min, Max ST and Min ST, etc. in every stage of the exercise
test in the list.
If an ergometer is used, you can view the information such as stage, stage time, exercise
time, Workload, BP, HR, DP, PVC, Max ST and Min ST, etc. in every stage of the
exercise test in the list.
NOTE: Double-click on HR/BP/METs/Max ST/Min ST/PVC/min and you can change
its value.
2. Stage time
It indicates the sampling time in a certain stage.
3. HR
The last HR value before entering the next stage is regarded as the HR in that stage.
4. BP
5. Max ST/Min ST
An ST value is calculated and saved every 10s in each stage during the test. The largest value
is the Max ST/Min ST in that stage.
6. DP
The DP value changes when the HR or BP value is modified manually.
7. PVC
It refers to the ventricular premature contraction occurred per minute in a certain stage.
NOTE: Only integers from 0 to 99 are allowed.
5.2.1.2 Summary Information
On the Summary Information area, you can view the protocol of the exercise test, view and
change the parameter values and diagnosis information.
1. Protocol information: including protocol name, total protocol time, and total exercise time.
2. Part of the parameters that can be edited are described as follows:
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DUKE score
It is automatically calculated by the system and is used to evaluate the follow-up
conditions after the exercise test.
DUKE Value
Risk Level
>5
Low
-10~5
Medium
<-10
High
NOTE: The DUKE value cannot be changed manually, but it automatically
changes after you manually change the Max ST Change or Pectoralgia
Type.
HR
Only integers from 0 to 350 are allowed.
BP
When in the unit of mmHg, only integers from 0 to 350 are allowed.
When in the unit of Kpa, the value must be a decimal fraction from 0-46.9, and only one
decimal digit is allowed.
Max Workload
The value must be a decimal fraction from 0 to 100.0, and only one decimal digit is
allowed.
Max ST/Min ST
Max ST: The value must be a decimal fraction from 0 to 0.80, and two decimal digits are
allowed.
Min ST: The value must be a decimal fraction from -0.80 to 0.80, and two decimal digits
are allowed.
Max ST Change
The value must be a decimal fraction from 0 to 0.5, and only one decimal digit is
allowed.
3. Diagnosis
Every time the sampling for exercise ECG is complete, you can fill out the diagnosis result
manually. The diagnosis result must be within 500 characters. When filling out the diagnosis
result, you can use a common diagnosis template in the Glossary, or you can customize the
glossary.
4. Diagnosis History
Click on History and you can view all the history diagnosis records of the current patient.
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5.2.1.3 Trend
On the summary analysis area, you can view the following:
HR Trend
BP Trend
DP Trend
Workload Trend
5.2.2 About the All View Screen
On the All View screen, you can view the ECG wave of one lead throughout the whole test and
easily locate the abnormal waveforms. The All View screen consists of the Thumbnail ECG
Display and Original ECG Display areas.
5.2.2.1 Thumbnail ECG Panorama
On the Thumbnail ECG Panorama window, you can view the changes between the heart rate and
waveforms during the test.
1. Select wave segment
Click on the waveform area and a rectangle will appear, covering the 10s-waveform
centered on where you clicked.
You can press the left or right direction key to shift the rectangle.
2. Select/print thumbnail ECG segment:
Click Seg Select and you can manually adjust the startpoint and endpoint for segment
printing.
Snapshot: After selecting an ECG segment, you can click Snapshot to save the ECG
segment, which can be viewed on the ECG Strip screen.
Click Print to print a report of the selected segment.
If you select Single-Lead ECG Report, the single-lead ECG will be printed; if you
select All-Lead ECG Report, the All-Lead ECG Report in the PSI ECG region will be
printed.
5.2.2.2 ECG Panorama of Three Rhythm Leads
On the All View screen, you can view the primary rhythm lead ECG of a thumbnail waveform.
On the rhythm lead ECG area, you can move the rollbar to view all the waveforms.
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5.2.2.3 12-Lead ECG Panorama
Click Full Screen on the All View screen and the all view window for 12-lead ECG will be
displayed; more information about the leads will be displayed. On the 12-lead ECG panorama
window, you can click Return to return to the PSI ECG window.
5.2.3 About the ECG Strip Screen
5.2.3.1 Strip
On the ECG Strip screen, you can review:
ECG strips printed manually or automatically
Snapshots
ECG strips with event marks
ECG strips with arrhythmia
Multi-selection: You can select multiple strips by clicking the strips one after another.
Edit Label: Click Edit Label and you can add a comment to the selected strips (multiple strips
can be selected simultaneously).
5.2.3.2 12-Lead ECG
Double-click on a strip on the ECG Strip window, you can open the corresponding original
12-lead ECG to obtain more detailed information about the waveforms and parameters.
5.2.4 ST Analysis
5.2.4.1 Average Template
On the Average Template window, you can view the ST trend for every 30s or every stage,
which can be configured on the right.
When the mouse pointer is settled in a waveform area, the pointer turns into a magnifier image.
Click on the waveform and a magnified image will be displayed. The mark lines on the magnified
image can be modified by dragging the mouse or pressing the arrow keys.
5.2.4.2 Max ST
On the Max ST window, you can view the highest ST value and its occurrence time of each lead.
When the mouse pointer is settled in a waveform area, the pointer turns into a magnifier image.
Click on the waveform and a magnified image will be displayed
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5.2.5 ST Trend
On the ST Trend window, you can view:
ST change trend
ST trend
STj trend
ST slope trend
ST/HR trend
Click on any point of the curve and you can view the ST value corresponding to the point.
Double-click on any point of the curve and you can open the all-lead waveform screen.
5.3 VCG
Vector ECG displays 3D image of ECG activity.
You can choose the plane and the vector loop on the VCG analysis screen. Plane choices include
Frontal, Horizontal, Sagittal and ALL. Loop choices include P loop, QRS loop, T loop and
ALL.
Click Re-analyze and the system automatically reanalyze the ECG data in the last 10s.
Item
Description
Mode
Auto: The system automatically chooses beats for analysis.
Manual: When enabled, manually click on the triangle symbol
displayed on the top to choose beats for analysis.
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5.3.1 Displaying Vector ECG with All Plane and All Loop
Set the plane to ALL and the loop to ALL.
Figure 5-2 Vector ECG - Plane of ALL and Loop of ALL
Figure 5-2 displays Vector ECG with the plane of ALL and the loop of ALL.
A- Vector ECG of Frontal
B- Vector ECG of Horizontal
C- Vector ECG of Sagittal
D- Average templates of X, Y and Z leads. Double-click on this figure to display the magnified
average template. You can drag these lines marked P1, P2, Q, S, T1 and T2 on the wave. With the
change of the line position, the corresponding parameter values change.
E- Click on the Parameter button to display the following Vector ECG parameter list.
D C G
A B E F
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Designation
Definition
Max Vector
The position of the maximal amplitude of QRS/P/T loop
(ms)
Amplitude
The amplitude of the Max vector of QRS/P/T loop (mV)
Angle
The angle of the Max vector of QRS/P/T loop (degree)
Direction
Rotation direction of QRS/P/T loop
CW
Clockwise
CCW
Counter-clockwise
8
‘8’ font ring
0.01 (amplitude)
The amplitude at 0.01s from QRS loop
0.01 (angle)
The angle at 0.01s from QRS loop
0.02 (amplitude)
The amplitude at 0.02s from QRS loop
0.02 (angle)
The angle at 0.02s from QRS loop
0.03 (amplitude)
The amplitude at 0.03s from QRS loop
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0.03 (angle)
The angle at 0.03s from QRS loop
0.04 (amplitude)
The amplitude at 0.04s from QRS loop
0.04 (angle)
The angle at 0.04s from QRS loop
Start Vector
Start point of QRS loop
End Vector
End point of QRS loop
ST Vector
The position of ST vector in vector loop
Length/Width
The ratio of length to width in T loop
T-R angle
The degree between the Max vector of T loop and the Max
vector of QRS loop (degree)
F- Click on 3D to display the 3D VCG graph.
G- Diagnosis Field
1. Enter your own opinions in the Diagnosis textbox, and then click on the OK button.
2. Or, double-click on the necessary results required to be added in the Glossary textbox, and
the selected results will be displayed in the Diagnosis textbox, and then click on the OK
button.
5.3.2 Displaying Vector ECG with Frontal Plane and QRS Loop
Figure 5-3 Vector ECG - Frontal & QRS loop
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The percent values in the square represent the area percentages of QRS loop in every quadrant.
20 mm/mV indicates the magnified multiple (gain). The red curve is QRS loop.
You can click on the Zoom in button or the Zoom out button to change the gain of the displayed
graphics. You can click on the Play button to watch the forming process of the QRS loop.
5.3.3 Displaying 3D Vector ECG
Click on 3D to display the 3D VCG graph.
3D (Three Dimensional Vector Loops)
This function allows you to observe the Vector ECG in three dimensions.
Select Rotate, and then you can rotate the whole picture to view all directions of the vector loops
by clicking the mouse.
Select Axis to display the axes.
Select Plane to display the planes.
Click on Zoom In/ Zoom Out to magnify/minify the picture.
Click on Reset to restore the magnified/minified picture to original size.
Click on Preview to preview the 3D graph.
Click on Print to print the 3D graph.
Click on Save to save the graph on the current screen.
Click on Return to return to the ECG analysis screen.
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5.4 HRV
The HRV ECG analysis screen includes two tabs: Auto Diagnosis result and Waveform.
NOTE:
1. The HRV sampling time can be set in the Sample Setting window.
2. The HRV analysis lead can be selected in the Sample Setting window.
Designation
Definition
Sampling Time
Set sampling time
Total Beat Number
Total beat number during the measuring course
Heart Rate
Heart rate
Average RR interval
Average RR interval
Max RR interval
Maximum RR interval
Min RR interval
Minimum RR interval
Max/Min
Ratio of Maximum RR interval to Minimum RR interval
SDNN
Standard Deviation of Normal to Normal Intervals
RMSSD
Root Mean Square Successive Difference
NN50
(the total beat number)
The number of duration difference that is more than 50ms between
the adjacent NN durations.
PNN50
(unit: per centum)
NN50 divide the total NN number
SDSD
Standard deviation of successive differences between adjacent
normal cycles
TINN
The triangular interpolation of NN interval histogram
Triangle Index
Total NN number divide the NN intervals of the highest percentage
LF
Low Frequency
HF
High Frequency
LF/HF
Ratio of low frequency to high frequency
LF (norm)
Standard LF power
HF (norm)
Standard HF power
Total Power
Total NN difference
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Doctor Diagnosis Field
1. Enter your own opinions in the Diagnosis textbox, and then click on the OK button.
2. Or, double-click on the necessary results required to be added in the Glossary textbox, the
selected results will be displayed in the Diagnosis textbox, and then click on the OK button.
HRV waveform is displayed in the Waveform window.
You can drag the mouse in the window to choose the wave field to be previewed or printed. Then
click on the Preview or Print button to preview/print the selected wave field.
5.5 Report Previewing
Click Preview on a screen and you can open the corresponding preview screen. The following
operations can also be performed:
1. Click Pre Page/Next Page to move into the previous/next preview screen.
2. Click to zoom in/out the preview area.
3. Click Print to print a report using the default printer.
4. Click Exit to close the print preview screen and return to its upper-level screen.
5.6 Report Printing
Click Print on the ECG analysis screen or print preview screen, and the default printer will print
the report.
For exercise ECG, click on Print on the Panorama and ECG Strip screen and only the
information displayed on the screen will be printed. On other screens, the report configured in the
settings window will be printed.
For resting ECG, click on Print on the Event Review screen, only the ECG strip report will be
printed. On other screens, the report configured in the settings window will be printed.
NOTE: The printer type is configured in the Printers and Faxes by the operating system.
You can set Print Setting in System Settings to Color. However, if a black and
white printer is used, only black and white reports can be printed.
5.7 Saving ECG Reports
You can click on the Report Save button to save ECG reports.
The report format includes PDF, WORD, JPG and BMP. Click on the Browse button to choose
the save path and click on OK to save the sampled data to the designated directory.
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If you select Send, the sampled data will be sent by Window Live Mail (Windows 7/Vista) when
it is saved to the designated directory.
NOTE: In Windows 7/Vista, only if Window Live Mail is installed, can the report be sent by
Email.
WARNING
The printouts need to be done with no scaling or sizing done to fit the page.
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Chapter 6 Archives
6.1 All List
Click Archives and then click All List, the following window will be displayed:
Figure 6-1 Archives window
6.1.1 Record Display
The All List screen can be displayed in two ways: focus on examination and focus on patient,
which can be configured by selecting or deselecting Focus on patient.
6.1.2 Modifying Patient Information
Select a patient record in the patient list and click Modify, the New Patient window will be
displayed. In the displayed window, you can modify the patient information. In this case,
modifications are made to all the patient's examination records at the same time.
Select an examination record in the examination record list and click Modify, the New Patient
window will be displayed. In the displayed window, you can modify the patient information. In
this case, the modifications are made only to the current examination record and other
examination records remain the same.
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6.1.3 Viewing Examination Records
Double-click on an examination record in the examination record list to open the ECG analysis
screen.
You can determine whether the examination record is confirmed by the doctor by checking the
examination status in the examination record list.
Unconfirmed:
The physician has not confirmed the diagnosis result, that is, the physician did not click on OK
on the analysis screen to confirm the diagnosis result.
Confirmed:
The physician has confirmed the diagnosis result, that is, the physician has clicked on OK on the
analysis screen to confirm the diagnosis result.
6.1.4 Deleting Examination Records
NOTE: Data cannot be recovered after being deleted. Be careful when deleting
examination records.
Select one or multiple patient records in the patient list and click Delete to delete the selected
patient records.
Select one or multiple examination records in the examination record list and click Delete to
delete the selected examination records.
6.1.5 Merging Examination Records
Select one or multiple examination records in the examination record list and click Merge, the
New Patient window will be displayed. In the displayed window, fill out the patient ID and click
OK, the selected examination records will be allocated to the patient.
6.1.6 Searching Patient Records
6.1.6.1Searching Examination Records
Configure the search criteria and click Search, all the examination records which meet the search
criteria will be displayed on the Archives screen.
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6.1.6.2 Advanced Search
Click More and the Exam. Record Advanced Search window will be displayed as follows:
6.1.7 Import
Click Select File, select the right directory and the patient data to be imported, and click Import
to import the patient data to the Archives screen.
NOTE: Only ECG data in DAT format can be imported.
6.1.8 Export
On the Archives screen, click Export and select the file format (SCP, FDA-XML, DICOM, and
DAT) and directory, and then click OK to export the patient data to the specified directory.
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6.2 Order List
Choose System Setting > Basic Setting, select Display Order List, and restart the system, the
Order List will be displayed in the Archives screen.
6.2.1 New Order
Fill out the patient information based on the patient and click OK. If the order is successful, the
patient record will be displayed in the Order List below.
6.2.2 Inbox
In the inbox, the doctor can quickly locate all the orders that are related to him/her.
6.2.3 Searching Information
After configuring the search criteria, click Search and all the related order information will be
displayed on the right.
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Chapter 7 Statistics
On the toolbar of the main screen, click Statistics to enter the Statistics window.
The Statistics window contains the following categories: Examination Department Workload
Count, Request Department Workload Count, Ref-Physician Count, Staff Workload Count,
Operating Device Count, Cost Count, and Measurement Analysis Count. You can calculate the
workload of the department, staff and operating devices, and calculate the cost of each
department or doctors, and calculate the patient data.
NOTE: The exam records disabled and deleted will not be calculated to workload.
1. Statistic criteria
If you want to select a department, tick it in the checkbox before it.
Appoint exam date: You can specify a time range by clicking Assign and choose a time.
Or, you can choose the starting date and the ending date in the time selection region.
The default time is Last month.
On the Measurement Analysis screen, if you want to cancel the configured conditions, select
the condition to be canceled, and press Delete.
2. Statistic results
After configuring the statistic criteria, click Statistics and the results will be displayed in the
list.
Right-click on the title of the Result List, and you can set the item to be displayed or hidden
by the pop-up menu. The item with a tick on the left will be displayed. Cancel the tick and
the item will not be displayed.
You can change the item sequence by dragging the item to the place you want.
Next time you log on to the system, you will find the item sequence is the same as you set
last time.
Click Export Excel and the statistic results will be exported as an Excel file.
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Chapter 8 System Setup
Click on the System Setting button on the main screen to open the System Setting window.
There are eight tabs in the System Setting window: Basic Information, Display Setting,
Transmission Setting, File Output Setting, GDT Setting, DicomWorklist Setting, Barcode Setting,
and Other Setting.
After you modify some information in the System Setting window, you can click on OK to save
these modifications and exit or click on Cancel to cancel these modifications and exit.
8.1 Basic Setup
Item
Description
Hospital Name and
Logo
Enter a hospital name in the Hospital Name textbox and it will be printed
on the report.
Click Set Hospital Logo and you can upload the hospital's logo.
Customize_1/2
When you fill in the Customize_1/2 textbox, the corresponding items in
the New Patient window will change into what is filled.
Memory
Select Memory in Basic Information window, the content of
Customize_1 in the New Patient window will be saved
If Memory is not selected, the content of Customize_1 in the New
Patient window will be empty.
ID Generating
Method
When the generating method is set to Auto, the patient ID can be
automatically generated according to the examination date.
When the generating method is set to Manual Input, you should enter the
patient ID manually in the New Patient window.
When the generating method is set to Accumulate, the patient ID can be
increased by one automatically. You need to set the format and the starting
number for ID.
Display Order List
When selected, the Order List will be displayed on the Archives screen.
Display All List
When selected, the All List will be displayed on the Archives screen.
Refresh Interval
The refresh interval can be configured between 5 and 600s.
Work Mode
Configure the advanced options.
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8.2 Display Setup
In the Display Setting window, you can select the items to be displayed on the New Patient and
order window. You can also configure the order function.
8.3 Transmission Setup
Item
Description
UART
Transmission
Enable UART transmission and select transmission protocol.
When Ymodem is selected, choose UART (Ymodem)
When EdanSerial is selected, choose UART.
Synchronize ECG
Time
When transmitting order records to an ECG machine, the system time of
the ECG machine will also be synchronized automatically.
Port
You can configure the COM ports used for serial transmission.
Match Type
Options provided are: Request No., Exam. ID., Patient ID, Outpatient
ID, Inpatient ID, Physical Exam. ID, and None.
No
When examination records are uploaded from the ECG machine, the
records will not be matched with the order information.
Request No./Exam. ID./Patient ID/Outpatient ID/Inpatient No.
When downloading order information to the ECG machine, the
patient ID in the ECG machine must be the same as the Request
No./Exam. ID./Patient ID/Outpatient /Inpatient No. of the patient.
Exam. Device
ECG machine
When checking the order information, the system automatically
receives data and waits for the data to be transmitted from the ECG
machine.
PC sampling box
When checking the order information, the system opens the
corresponding sampling screen based on the checked item.
Hint Mode
Options provided are Sound, Blink, and Diaglog Box
Hint Sound
The Hint Sound can be configured only when Hint Mode is set to
Sound.
Hint Sound
The Hint Sound Interval can be configured only when Hint Mode is set
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Interval
to Sound.
Options provided are Hint once, Hint every 30s, Hint every 60s, Hint
every 120s and Continuous Hint.
When Hint once is selected, the system reminds the user only when data
is received.
Auto Diagnosis
When this function is selected, the diagnosis results automatically
displays on the analysis window after the data has been received.
Reserve Examined
Order
When this function is selected, the examined orders will remain in the
order list for specified time.
Enter analysis after
uploading
When this function is selected, the system automatically switches to the
analysis screen after the data has been uploaded.
Deliver after
diagnosis
When this function is selected, the status of a record diagnosed on the
analysis screen will be changed into Delivered automatically.
8.4 Output File Setup
Item
Description
File name
Setting
The file name consists of the ID, name, exam time, age, and gender.
The default file name is: Patient ID-Name.
NOTE: The file name you configured cannot be empty and at least
one item has to be selected or set.
Auto export after
sampling
finishes
When selected, the system will automatically output files in the
corresponding format when sampling finishes.
Output when
making
diagnosis,
When selected, the system will automatically output files in the
corresponding format when making diagnoses.
Output path
Click on Browse to specify the output path.
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8.5 GDT Setup
NOTE: This is an optional advanced function. To activate it, please contact the local
distributor.
Item
Description
Enable GDT
Select Enable GDT and then select .GDT or .001 according to the actual
work stream.
GDT Path
Click on Browse to specify a path to exchange files with the EDP.
Input File Name
The command file name sent to the software from the EDP.
Output File Name
The data file name sent to the EDP from the software.
ECG ID
The name allocated to the software by the EDP.
EDP ID
8315 or 8316 in the GDT protocol.
Output GDT file
when sampling
stops
When selected, the system automatically outputs a GDT file after the
sampling is complete.
Output GDT file
when making
diagnosis
When selected, the system automatically outputs a GDT file after the
diagnosis is complete.
8.6 DICOM Setup
NOTE: This is an optional advanced function. To activate it, please contact the local
distributor.
Item
Description
Enable DICOM Worklist
When selected, the DICOM Worklist function will be activated.
Refresh Interval
Set the refresh interval for automatic worklist download.
Upper Download Limit
Set the upper limit of patient records during an automatic
download.
Auto Worklist
When selected, the system automatically downloads worklists from
the server in batch.
ECHO
Click to test whether DICOM connection is successful.
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Server IP/Server
Port/Server AE/Client AE
Set Server IP/Server Port/Server AE/Client AE to the server
IP/server port/server AE/client AE used for the DICOM Worklist
system.
DICOM Store Setting
Set the time when DICOM files are stored to the server.
8.7 HL7 Setup
NOTE: This is an optional advanced function. To activate it, please contact the local
distributor.
The ECG workstation allows obtaining patient information and uploading files through the HL7
workflow.
8.8 Barcode Setup
Item
Description
Barcode Setting
Configure the Start Address, End Address, Male Code/Female Code,
and Device Port for each sub-item based on the actual situation.
NOTE: Only the USB bar code reader recommended by the
manufacturer can be used.
1. If the bar code reader is connected before starting the software, the software automatically
detects the reader. In this case, you can use it without port configuration or initialization.
2. If the bar code reader is connected after starting the software, you have to initialize the bar
code reader in System Setting.
3. If the initialization fails, you have to manually configure the port by performing the
following operations:
1) Connect the USB bar code reader to the computer.
2) On the computer, click Start and right-click on My Computer, and then choose
Manage.
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3) In the Computer Management window, click Device Manager and select Human
Interface Devices to view the ports.
4) After setting the device port to the viewed port on the Barcode Setting window, click
Yes to restart the SE-1515 software.
8.9 Other Setup
Item
Description
System
Maintenance
Production Activation
System Password Setting
After the password has been changed successfully, you have to enter
the new password to enter the System Settings window.
Advanced Setting:
Refer to section 8.9.2 for details.
Regional Options
The system language, date format, time format, and the unit of blood
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pressure, height and weight can be configured.
Theme
To set the system color scheme.
Automatically set
to normal after
printing
If enabled, the system automatically changes the status of a exmination
record from Emergent to Normal after printing its report.
8.9.1 Product Authorization
For details, refer to SE-1515 PC ECG Installation Guide.
8.9.2 Advanced Setting
8.9.2.1 Examination Department and Device Management
On the Exam. Dept. and Device Management window, fill the device ID to the Device ID
column and configure the Parent Department and Device Name. Click Save (S) to save the
configuration. You can modify the department name, add or delete data entries.
8.9.2.2 Examination Type and Item Management
Click on Exam. Type and Item Management, you can modify the value and unit of the cost.
8.9.2.3 User Management
Click on User Management and you can search the list by user ID or user name.
Click Search and you can search for user information based on the conditions set.
Under User List, you can click Add (A) to add new users and set their rights; click Modify (M)
to modify basic user information.
To switch between multiple user accounts, choose Setting>Basic Setting, and select Enable
System Login in local mode settings.
8.9.2.4 Data Maintenance
Click on Data Maintenance, you can perform data backup and recovery settings.
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The name of the backup folder does not allow special characters or letters in languages other than
English.
8.9.2.5 Request Department Management
Click on Request Dept. Management, you can modify the department name, add or delete
department data.
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Chapter 9 Hint Information
Hint information and the corresponding causes provided by the system are listed as follows:
Table 9-1 Hint Information and Causes
Hint Information
Causes
Lead off: X
Electrodes fall off the patient or the patient cable
falls off the ECG sampling box.
No sentinel detected!
The sentinel is not inserted.
No sampling box detected, enter DEMO
display?
The software is started without connecting the
sampling box.
Communication failure: Please check
whether the USB cable is connected. You
can reconnect the USB cable and try it
again.
The USB cable is disconnected or the
communication between the ECG sampling box
and the serial port is interrupted.
1. Reconnect the ECG sampling box to the PC.
2. Click on the Device tab in the System Setting
window of the SE-1515 system, and check
whether the sampling device is set correctly.
3. The USB cable falls off the PC during the
sampling process.
Battery of sampling device is weak,
please change the battery after the test.
Battery of DX12 transmitter is low.
Battery is weak, the sampling device is
closing.
Battery of DX12 transmitter is low.
Sampling Device is in sleep mode, please
press "Power" to activate it.
DX12 transmitter is in sleep mode.
Overload
The direct current offset voltage on an electrode is
too high.
Fail to create database!
The system fails to create database.
The current HR has exceeded the target
HR!
Current heart rate value exceeds the target heart
rate value.
The diastolic BP has exceeded the
normal range!
Diastolic blood pressure exceeds the normal BP
range.
The systolic BP has exceeded the normal
range!
Systolic blood pressure exceeds the normal BP
range.
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Chapter 10 Cleaning, Care and Maintenance
Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect
your equipment. Warranty does not cover damage caused by using unapproved substances or
methods.
Edan Instruments has validated the cleaning and disinfection instructions provided in this User
Manual. It is the responsibility of the healthcare professional to ensure that the instructions are
followed so as to ensure adequate cleaning and disinfection.
10.1 General Points
Keep your sampling box and accessories free of dust and dirt. To prevent the device from damage,
please follow the instructions:
Use only the recommended cleaning agents and disinfectants listed in this manual. Others
may cause damage (not covered by warranty), reduce product lifetime or cause safety
hazards.
Always dilute according to the manufacturer's instructions.
Unless otherwise specified, do not immerse any part of the equipment or any accessories in
liquid.
Do not pour liquid onto the equipment.
Do not allow liquid to enter the case.
Never use abrasive material (such as steel wool or silver polish).
Inspect the sampling box and reusable accessories after they are cleaned and disinfected.
CAUTION
If you spill liquid on the equipment or accessories, or they are accidentally immersed in
liquid, contact your service personnel or EDAN service engineer.
10.2 Cleaning
If the equipment or accessory has been in contact with the patient, then cleaning and disinfection
is required after each use.
The validated cleaning agents for cleaning the sampling box and patient cable are:
Mild near neutral detergent
Ethanol (75%)
Isopropanol (70%)
The validated cleaning agent for cleaning the reusable electrodes is:
Mild near neutral detergent
SE-1515 PC ECG User Manual Cleaning, Care and Maintenance
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Cleaning agents should be applied or removed using a clean, soft, non-abrasive cloth or paper
towel.
10.2.1 Cleaning the Sampling Box
WARNING
When the DX12 transmitter is used, turn off the power, disconnect the patient cable, and
take out the battery before cleaning.
1. Wipe the exterior surface of the equipment using a soft cloth dampened with the cleaning
solution until no visible contaminants remain.
2. Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after
cleaning until no visible cleaning agent remains.
3. Dry the equipment in a ventilated and cool place.
10.2.2 Cleaning the Patient Cable
1. Wipe the patient cable with a soft cloth dampened with the cleaning solution until no visible
contaminants remain.
2. Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after
cleaning until no visible cleaning agent remains.
3. Wipe off with a dry cloth to remove residual moisture.
4. Leave the patient cable to air dry.
CAUTION
Any remainder of cleaning solution should be removed from the sampling box and the
patient cable after cleaning.
10.2.3 Cleaning the Reusable Electrodes (for Resting ECG)
1. Wipe off with a soft cloth to remove residual gel.
2. Wipe the suction bulbs of chest electrodes and the clamps of limb electrodes with a soft cloth
dampened with the cleaning solution until no visible contaminants remain.
3. Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after
cleaning until no visible cleaning agent remains.
4. Wipe off with a dry cloth to remove residual moisture.
5. Leave the suction bulbs and clamps to air dry.
SE-1515 PC ECG User Manual Cleaning, Care and Maintenance
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10.3 Disinfection
To avoid permanent damage to the equipment, it is recommended that disinfection is performed
only when it is considered as necessary according to your hospital' regulations.
Clean the equipment and reusable accessories before they are disinfected. The validated
disinfectants for disinfecting the sampling box and patient cable are:
Ethanol (75%)
Isopropanol (70%)
The validated disinfectant for disinfecting the reusable electrodes is:
Isopropanol (70%)
If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required
to be used for the disinfection step.
CAUTION
1. Do not use high-temperature, high-pressure vapour or ionizing radiation as
disinfection methods.
2. Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.
3. Clean and disinfect reusable electrodes after each use.
10.3.1 Disinfecting the Sampling Box
WARNING
When the DX12 transmitter is used, turn off the power, disconnect the patient cable, and
take out the battery before disinfection.
1. Wipe the exterior surface of the equipment using a soft cloth dampened with the disinfectant
solution.
2. Wipe off the disinfectant solution with a dry cloth after disinfection if necessary.
3. Dry the equipment for at least 30 minutes in a ventilated and cool place.
10.3.2 Disinfecting the Patient Cable
1. Wipe the patient cable with a soft cloth dampened with the disinfectant solution.
2. Wipe off the disinfectant solution with a dry cloth after disinfection.
3. Leave the patient cable to air dry for at least 30 minutes.
10.3.3 Disinfecting the Reusable Electrodes (for Resting ECG)
1. Wipe the suction bulbs of chest electrodes and the clamps of limb electrodes with a soft cloth
dampened with the disinfectant solution.
SE-1515 PC ECG User Manual Cleaning, Care and Maintenance
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2. Wipe off the disinfectant solution with a dry cloth after disinfection.
3. Leave the suction bulbs and clamps to air dry for at least 30 minutes.
10.4 Maintenance of ECG Sampling Box
CAUTION
Besides the maintenance requirements recommended in this manual, comply with local
regulations on maintenance and measurement.
The following safety checks should be performed at least every 12 months by a qualified person
who has adequate training, knowledge, and practical experience to perform these tests.
a) Inspect the equipment and accessories for mechanical and functional damage.
b) Inspect the safety related labels for legibility.
c) Verify that the device functions properly as described in the instructions for use.
d) Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm.
e) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 μA, SFC
1000 μA
f) Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100 μA,
SFC 500 μA.
g) Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10 μA, d.c.
10 μA; SFC a.c. 50 μA, d.c. 50 μA.
h) Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10 μA,
d.c. 10 μA; SFC a.c. 50 μA, d.c. 50 μA.
i) Test the patient leakage current under single fault condition with mains voltage on the
applied part according to IEC/EN 60601-1: Limit: 50 μA (CF).
j) Test the essential performance according to IEC/EN 60601-2-25, or methods
recommended by the hospital or local distributor.
The data should be recorded in an equipment log. If the equipment is not functioning properly or
fails any of the above tests, the equipment has to be repaired.
WARNING
Failure on the part of the responsible individual hospital or institution employing this
equipment to implement a satisfactory maintenance schedule may cause undue
equipment failures and possible health hazards.
SE-1515 PC ECG User Manual Accessories
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Chapter 11 Accessories
Accessory
Part Number
DE15 ECG Sampling Box (IEC)
02.01.210720
DE15 ECG Sampling Box (AHA)
02.01.210727
DE18 ECG Sampling Box (IEC)
02.01.211212
DE18 ECG Sampling Box (AHA)
02.01.211213
18-Lead Patient Cable (AHA)
01.57.471393
18-Lead Patient Cable (IEC)
01.57.471394
16-Lead Patient Cable (IEC)
01.57.471306
16-Lead Patient Cable (AHA)
01.57.471305
Adult Chest Electrodes
01.57.040163
Adult Limb Electrodes
01.57.040162
Resting ECG USB Cable
01.13.036134
Portable Bag
01.56.465623
DP12 ECG Sampling Box
02.01.210039
PC ECG&Stress ECG (DX12) Transmitter
02.06.260163
PC ECG&Stress ECG (DX12) Receiver
02.06.260164
DX12 Patient Cable (IEC)
01.57.471278
DX12 Patient Cable (AHA)
01.57.471279
DX12 Patient Cable (IEC)
01.57.471030
DX12 Patient Cable (AHA)
01.57.471055
12-Lead Patient Cable (IEC)
01.57.471500
12-Lead Patient Cable (IEC)
01.57.471613
SE-1515 PC ECG User Manual Accessories
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12-Lead Patient Cable (AHA)
01.57.471499
12-Lead Patient Cable (AHA)
01.57.471614
12-Lead Patient Cable (IEC)
01.57.109850
12-Lead Patient Cable (AHA)
01.57.109851
Pediatric Chest Electrodes
01.57.040168
Pediatric Limb Electrodes
01.57.040169
Disposable Adult Snap Socket Electrode
01.57.471056
Disposable Pediatric Snap Socket Electrode
01.57.471057
Disposable Clip-on Electrode Adapter
01.57.471031
Disposable Snap Socket Electrode
01.57.471046
Snap Electrode Adaptation Cable
01.13.107449
Multi-Function Electrode Adapter
01.57.040172
Clip-on Electrode Adapter
01.57.040173
Patient Cable for Exercise ECG
01.13.036135
DP12 Belt
01.57.106750
DX12 Belt
01.57.471054
DE15 Belt
01.56.465354
Smart ECG Viewer Dongle
02.01.047227
Exercise ECG Dongle
01.18.047229
LS4208 Bar Code Reader (One-Dimension)
01.23.068023
1900GSR-2 Bar Code Reader (Two-Dimension)
21.18.052311
NOTE:
1. Smart ECG Viewer Dongle and Exercise ECG Dongle are used for supporting the
authorization of the data management and Exercise ECG function.
2. The part name may vary depending on context, but the part number is constant.
SE-1515 PC ECG User Manual Accessories
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Recommended Optional Accessories
Treadmill:
Model: TM-400
Manufacturer: EDAN INSTRUMENTS, INC. China
CE marking
Model: Valiant
Manufacturer: Lode B.V. The Netherlands
CE marking
Model: h/p/cosmos (all medical models) with coscom interface
Manufacturer: Full Vision Inc. USA
CE marking
Model: mercury med 4.0, mercury 4.0
Manufacturer: h/p/cosmos sports & medical gmbh Germany
CE marking
Model: RUNNER RUN-2011/T
Manufacturer: Runner srl
CE marking
Model: TMX428
Manufacturer: Full Vision, Inc.
CE marking
Ergometer:
Model: sana bike 120F, sana bike 150F, sana 250F
Manufacturer: ergosana gmbh Germany
CE marking
Model: ergoselect 100P/100K, ergoselect 200P/200K
Manufacturer: ergoline gmbh Germany
CE marking
Model: Corival
Manufacturer: Lode B.V. The Nettherlands
CE marking
STRESS BP:
Model: Tango M2
Manufacturer: SunTech Medical Inc. USA
CE marking
SE-1515 PC ECG User Manual Accessories
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WARNING
1. The electrical outlet and the isolating transformer shall only be used for supplying
power to the part of the system.
2. It will harm the wall outlet to connect the non-medical electrical equipment of the
SE-1515 system directly to the wall outlet, because the non-medical electrical
equipment of the system is intended to be powered by using the electrical outlet and
the isolating transformer.
3. An additional multiple portable socket-outlet or extension cord shall not be connected
to the system.
4. The electrical outlet and the isolating transformer shall not be placed on the floor.
SE-1515 PC ECG User Manual Warranty & Service
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Chapter 12 Warranty & Service
12.1 Warranty
EDAN warrants that EDAN's products meet the labeled specifications of the products and will be
free from defects in materials and workmanship that occur within warranty period.
The warranty is void in cases of:
1. damage caused by mishandling during shipping.
2. subsequent damage caused by improper use or maintenance.
3. damage caused by alteration or repair by anyone not authorized by EDAN.
4. damage caused by accidents.
5. replacement or removal of serial number label and manufacture label.
If a product covered by this warranty is determined to be defective because of defective materials,
components, or workmanship, and the warranty claim is made within the warranty period, EDAN
will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide
a substitute product for use when the defective product is being repaired.
12.2 Contact Information
If you have any question about maintenance, technical specifications or malfunctions of devices,
contact your local distributor.
Alternatively, you can send an email to EDAN service department at: support@edan.com.cn.
SE-1515 PC ECG User Manual Technical Specifications
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Appendix 1 Technical Specifications
A1.1 Safety Specifications
Comply with:
IEC 60601-1:2005/A1:2012
EN 60601-1:2006/A1:2013
IEC 60601-1-2:2007
EN 60601-1-2:2007/AC:2010
IEC 60601-2-25:2011
Anti-electric-shock type:
Class ІI
Anti-electric-shock
degree:
Type CF with defibrillation-proof
Degree of protection
against harmful ingress of
water:
Ordinary equipment (Sealed equipment without liquid proof)
Disinfection/sterilization
method:
Refer to the user manual for details (Please see Chapter 10,
"Cleaning, Care and Maintenance")
Degree of safety of
application in the presence
of flammable gas:
Equipment not suitable for use in the presence of flammable gas
Working mode:
Continuous operation
EMC:
CISPR 11, Group 1, Class A
Patient Leakage
Current:
NC
<10μA (AC) / <10μA (DC)
SFC
<50μA (AC) / <50μA (DC)
Patient Auxiliary
Current:
NC
<10μA (AC) / <10μA (DC)
SFC
<50μA (AC) / <50μA (DC)
A1.2 Environment Specifications
Transport & Storage
Working
Temperature:
DP12/DE15/DE18 ECG
sampling box:
-40ºC (-8ºF) ~ +55ºC (+131ºF)
+5ºC (+41ºF) ~ +40ºC (+104ºF)
SE-1515 PC ECG User Manual Technical Specifications
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DX12 ECG sampling box:
-20ºC (-4ºF)~+55ºC (+131ºF)
Relative Humidity:
25%RH~93%RH
Non-Condensing
25%RH~80%RH
Non-Condensing
Atmospheric Pressure:
70 kPa ~106 kPa
86 kPa ~ 106 kPa
A1.3 Physical Specifications
Dimensions
DE18/DE15 ECG sampling box: 139mm× 96mm × 25mm, ± 5mm
DP12 ECG sampling box: 148mm (L) ×100 mm (W) × 40mm (H) , ± 2mm
DX12 transmitter: 63mm(L)×107mm(W) ×23mm(H), ± 2mm
DX12 receiver: 155mm(L)×100mm(W)×30mm(H), ± 2mm
Weight
DE15/DE18 ECG sampling box: Approx. 215g
DP12 ECG sampling box: Approx. 210g
DX12 transmitter: Approx. 113g (not including battery)
DX12 receiver: Approx. 173g
A1.4 Power Supply Specifications
Power Supply:
PC
Operating Voltage: 110V-240V~
Operating Frequency: 50 Hz/60Hz
DE18/DE15 ECG
Sampling Box
DC 5V
Input Power: 1 VA(MAX), 0.5 VA(MIN)
DP12 ECG
Sampling Box
5V, 1VA (MAX), 0.5VA (MIN)
DX12 transmitter
Input Power: 2x1.5V Excell Alkaline AA IEC LR6;
Operation life of battery ≥12 hours
DX12 receiver
DC 5V
Input Power: 350mW
SE-1515 PC ECG User Manual Technical Specifications
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A1.5 Performance Specifications
HR Recognition
HR Range
30 bpm ~300 bpm
Accuracy
±1 bpm
ECG Sampling Box Performance
Leads
DE18
18 leads
DE15
16 leads
DP12/DX12
12 leads
Acquisition Mode
DE18
simultaneously 18 leads
DE15
simultaneously 16 leads
DP12/DX12
simultaneously 12 leads
Sample Frequency
DE18/DE15
1kHz (Analysis)
16kHz (Sampling)
DP12
1kHz (Analysis)
1kHz (Sampling)
DX12
0.5kHz (Analysis)
10kHz (Sampling)
A/D
DE18/DE15/DP12
24 bits
DX12
18bits
Resolution
DE18/DE15
0.1575uV/LSB
DP12/ DX12
2.52uV/LSB
Input Voltage Range
<±5mVp-p
Time Constant
≥3.2s
SE-1515 PC ECG User Manual Technical Specifications
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CMRR
DE18/DE15
≥123dB (AC OFF)
DP12
≥115dB (AC OFF)
DX12
≥100dB (AC OFF)
Frequency Response
DE18/DE15
0.01Hz~300Hz (-3dB)
DP12/DX12
0.05Hz~150Hz (-3dB)
Gain
2.5, 5, 10, 20, 10/5, AGC (mm/mV)
Input Impedance
DE18/DE15
≥100MΩ
DP12
≥50MΩ
DX12
≥20MΩ
Input Circuit Current
≤10 nA
Calibration Voltage
1mV ± 2%
DC Offset Voltage
DE18/DE15/DP12
±600mV
DX12
±500mV
Minimum Amplitude:
20 μVp-p
Noise
DE18/DE15/DP12
≤12.5μVp-p
DX12
≤15μVp-p
Recovery Time After
Defibrillation
<5 s
Multichannel crosstalk
≤0.5mm
Patient
Leakage
Current:
NC
<10μA (AC) / <10μA (DC)
SFC
<50μA (AC) / <50μA (DC)
Patient
Auxiliary
Current:
NC
<10μA (AC) / <10μA (DC)
SFC
<50μA (AC) / <50μA (DC)
SE-1515 PC ECG User Manual Technical Specifications
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Insulation
4000Vrms/min
Filter
AC
DE18/DE15/DX12
50Hz/60Hz/Off
EMG
DE18/DE15/ DX12
25Hz/35Hz/45Hz/Off
DFT
DX12
0.05Hz/0.32Hz/0.67Hz
DE18/DE15
0.01Hz/0.05Hz/0.32Hz/0.67Hz
LOWPASS
Filter
DX12
150Hz/100Hz/75Hz
DE18/DE15
300Hz/270Hz/150Hz/100Hz
/150Hz/100Hz/75Hz
Pacemaker Detection
DE18/DE15
±750uV ~ ±700mV, 50us ~ 2.0ms
DP12
±2mV ~ ±700mV, 0.1ms ~ 2.0ms
DX12
±2mV ~ ±500mV, 0.1ms ~ 2.0ms
DX12 Bluetooth
Transmitting Frequency
2402-2480Hz
Frequency Band
2402-2480Hz
Modulation Type
FHSS
Transmitting Power
4.65dBM
Effective Radiated
Power
2.65dBM
NOTE: Operation of the equipment below the minimum amplitude may cause inaccurate
results.
SE-1515 PC ECG User Manual EMC Information
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Appendix 2 EMC Information
Electromagnetic Emissions
Guidance and manufacture's declaration - electromagnetic emission
SE-1515 PC ECG is intended for use in the electromagnetic environment specified below. The
customer or the user of SE-1515 PC ECG should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
SE-1515 PC ECG uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emission
CISPR 11
Class A
SE-1515 PC ECG is suitable for use in all
establishments, other than domestic and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Electromagnetic Immunity
Guidance and manufacture's declaration - electromagnetic immunity
SE-1515 PC ECG is intended for use in the electromagnetic environment specified below. The
customer or the user of SE-1515 PC ECG should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood,
concrete or ceramic tile. If
floor are covered with
synthetic material, the
relative humidity should be
at least 30%.
SE-1515 PC ECG User Manual EMC Information
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Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
Not applicable
Not applicable
Surge
IEC 61000-4-5
1 kV line to line
2 kV line to ground
Not applicable
Not applicable
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Not applicable
Not applicable
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Electromagnetic Immunity
Guidance and manufacture's declaration - electromagnetic immunity
SE-1515 PC ECG is intended for use in the electromagnetic environment specified below. The
customer or the user of SE-1515 PC ECG should assure that it is used in such an environment.
SE-1515 PC ECG User Manual EMC Information
- 101 -
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted
RF
IEC61000-
4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
Portable and mobile RF communications
equipment should be used no closer to any part of
SE-1515 PC ECG, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Pd 2.1
Radiated
RF
IEC61000-
4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
Pd 2.1
80 MHz to 800 MHz
Pd 3.2
800 MHz to 2.5 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a,
should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
SE-1515 PC ECG User Manual EMC Information
- 102 -
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which SE-1515 PC ECG is
used exceeds the applicable RF compliance level above, SE-1515 PC ECG should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating SE-1515 PC ECG.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM
Recommended separation distances between
portable and mobile RF communications equipment and SE-1515 PC ECG
SE-1515 PC ECG is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of SE-1515 PC ECG can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and SE-1515 PC ECG as recommended below,
according to the maximum output power of the communications equipment.
Rated
maximum
output power
of transmitter
(W)
Separation distance according to frequency of transmitter
(m)
150 kHz to 80 MHz
Pd 2.1
80 MHz to 800 MHz
Pd 2.1
800 MHz to 2.5 GHz
Pd 3.2
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
SE-1515 PC ECG User Manual Abbreviations
- 103 -
Appendix 3 Abbreviations
Abbreviation
Full Description
LCD
Liquid Crystal Display
BP
Blood Pressure
ECG
Electrocardiogram/Electrocardiograph
HR
Heart Rate
AC
Alternating Current
USB
Universal Serial Bus
AGC
Auto Gain Control
NC
Normal Condition
SFC
Single Fault Condition
