EDAN SE-1200 Series User manual

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文件名称：SE-1200系列说明书_英文
文件编号：01.54.106764
版本：2.1
产品型号：SE-1200 Express;SE-1200
项目编码：2082C000
签批信息:
作者 : 肖, 丽军 (xiaolijun) 2016-01-07 17:18:55
审核人 : 陈, 勇强 (chenyongqiang) 2016-01-07 17:57:31
审核人 : 肖, 玉华 (xiaoyuhua) 2016-01-07 17:34:53
审核人 : 童, 晓密 (tongxiaomi) 2016-01-07 17:29:18
批准人 : 黄, 玉平 (huangyuping) 2016-01-08 14:30:45
版权©深圳市理邦精密仪器股份有限公司
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About this Manual
P/N: 01.54.106764
MPN: 01.54.106764021
Release Date: January, 2016
© Copyright EDAN INSTRUMENTS, INC. 2007-2016. 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.
Product Information
Product Name: Electrocardiograph
Model: SE-1200, SE-1200 Express
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
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persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.
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Table of Contents
Chapter 1 Safety Guidance ........................................................................................................... 1
1.1 Indications for Use/Intended Use ........................................................................................... 1
1.2 Warnings and Cautions ........................................................................................................... 1
1.2.1 Safety Warnings ............................................................................................................... 2
1.2.2 Li-ion Battery Care Warnings .......................................................................................... 5
1.2.3 General Cautions.............................................................................................................. 6
1.3 List of Symbols....................................................................................................................... 7
Chapter 2 Introduction................................................................................................................ 11
2.1 Top Panel .............................................................................................................................. 11
2.2 Keyboard and Keys .............................................................................................................. 12
2.3 Front Panel............................................................................................................................ 14
2.4 Rear Panel............................................................................................................................. 15
2.5 Right Panel ........................................................................................................................... 16
2.6 Bottom Panel ........................................................................................................................ 19
2.7 Features................................................................................................................................. 20
Chapter 3 Operation Preparations............................................................................................. 22
3.1 Connecting the Patient Cable to the Electrocardiograph and Electrodes ............................. 22
3.1.1 Connecting the Patient Cable to the Electrocardiograph ............................................... 22
3.1.2 Connecting the Patient Cable to Electrodes ................................................................... 22
3.2 Preparing the Patient............................................................................................................. 23
3.2.1 Instructing the Patient .................................................................................................... 23
3.2.2 Preparing the Skin.......................................................................................................... 23
3.3 Attaching Electrodes to the Patient....................................................................................... 24
3.3.1 Electrode Placement....................................................................................................... 24
3.3.2 Attaching the Reusable Electrodes................................................................................. 26
3.3.2.1 Attaching the Limb Electrodes ................................................................................ 26
3.3.2.2 Attaching the Chest Electrodes................................................................................ 27
3.3.3 Attaching the Disposable Electrodes.............................................................................. 27
3.4 Inspection Before Power-On ................................................................................................28
3.5 Turning On/Off the Electrocardiograph................................................................................ 29
3.6 Loading/Replacing Recorder Paper...................................................................................... 31
Chapter 4 Basic Operation Guidance ........................................................................................ 35
4.1 Navigation Tips..................................................................................................................... 35
4.1.1 Selecting Menu Functions.............................................................................................. 35
4.1.2 Entering Data ................................................................................................................. 36
4.1.3 Selecting an Item............................................................................................................ 37
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4.2 Configuring the Electrocardiograph ..................................................................................... 37
4.3 Screen Description................................................................................................................ 38
4.3.1 About the Main Screen................................................................................................... 38
4.3.2 About the System Setup Screen .....................................................................................42
4.3.3 About the Order Manager Screen................................................................................... 43
4.3.4 About the File Manager Screen...................................................................................... 44
4.4 Work Mode Description........................................................................................................ 47
Chapter 5 Entering Patient Information ................................................................................... 48
5.1 Entering Patient Information Manually................................................................................ 48
5.2 Entering Patient Information by Using a Reader (Optional)................................................ 49
5.3 Entering Patient Information by Acquiring Orders .............................................................. 49
Chapter 6 Printing ECG Reports ............................................................................................... 51
6.1 Printing an ECG Report........................................................................................................ 51
6.1.1 Auto Mode...................................................................................................................... 51
6.1.2 Manual Mode ................................................................................................................. 52
6.1.3 Rhythm Mode................................................................................................................. 53
6.1.4 R-R Analysis Mode........................................................................................................ 54
6.1.5 VCG Mode (Only Configurable for SE-1200 Express) ................................................. 55
6.2 Copy Printing........................................................................................................................ 57
6.3 Freezing ECG Waves............................................................................................................ 57
6.4 Printing a Stored ECG Report .............................................................................................. 59
6.4.1 Printing on the File Manager Screen1/2......................................................................... 59
6.4.2 Printing on the Preview Screen ...................................................................................... 59
6.5 ECG Reports......................................................................................................................... 60
6.5.1 Auto ECG Report ........................................................................................................... 60
6.5.2 Auto ECG Report Printed by the USB Printer............................................................... 64
Chapter 7 Transmitting ECG Data............................................................................................. 65
7.1 Transmitting ECG Data to the PC ........................................................................................ 65
7.1.1 Transmitting ECG Data in DAT V1.03 Format Through Serial Cable .......................... 65
7.1.2 Transmitting ECG Data in DAT and DAT V1.03 Format Through Ethernet Cable ...... 66
7.1.3 Transmitting ECG Data in SCP/FDA-XML/PDF/DICOM Format Through Ethernet
Cable ....................................................................................................................................... 67
7.2 Real-time Transmission to SE-1515 ..................................................................................... 67
Chapter 8 Managing Orders....................................................................................................... 69
8.1 Loading Orders ..................................................................................................................... 69
8.2 Examining Orders................................................................................................................. 70
8.3 Deleting Orders..................................................................................................................... 70
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8.4 Searching Orders .................................................................................................................. 70
8.5 Setting Orders ....................................................................................................................... 71
8.5.1 Factory Defaults of Orders............................................................................................. 71
8.5.2 Order Setup .................................................................................................................... 71
Chapter 9 Managing Files ........................................................................................................... 73
9.1 Transmitting Files ................................................................................................................. 73
9.2 Exporting Files ..................................................................................................................... 73
9.3 Deleting Files........................................................................................................................ 74
9.4 Searching Files ..................................................................................................................... 74
9.5 Importing Files ..................................................................................................................... 75
9.6 Editing Patient Information .................................................................................................. 75
9.7 Printing Files......................................................................................................................... 75
9.8 Previewing a File .................................................................................................................. 75
9.8.1 SE-12 Express ................................................................................................................ 76
9.8.2 SE-12.............................................................................................................................. 77
Chapter 10 System Setup............................................................................................................. 79
10.1 Factory Defaults ................................................................................................................. 79
10.2 Work Mode Setup ............................................................................................................... 84
10.3 Filter Setup ......................................................................................................................... 85
10.4 Record Info Setup............................................................................................................... 87
10.4.1 Setup 1.......................................................................................................................... 87
10.4.2 Setup 2.......................................................................................................................... 89
10.4.3 Setup 3.......................................................................................................................... 91
10.5 Patient Information Setup................................................................................................... 92
10.6 Transmission Setup............................................................................................................. 94
10.6.1 Basic Setup................................................................................................................... 94
10.6.2 WIFI Setup (Optional) ................................................................................................. 95
10.7 Lead Setup .......................................................................................................................... 97
10.8 Display&Sound Setup ........................................................................................................ 98
10.9 Date&Time Setup ............................................................................................................. 100
10.10 File Setup........................................................................................................................ 101
10.11 System Maintenance Setup............................................................................................. 102
10.12 Other Setup ..................................................................................................................... 103
Chapter 11 Hint Information .................................................................................................... 105
Chapter 12 FAQ ......................................................................................................................... 106
Chapter 13 Cleaning, Care and Maintenance ......................................................................... 110
13.1 General Points................................................................................................................... 110
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13.2 Cleaning............................................................................................................................ 110
13.2.1 Cleaning the Main Unit.............................................................................................. 111
13.2.2 Cleaning the Patient Cable ......................................................................................... 111
13.2.3 Cleaning the Reusable Electrodes.............................................................................. 111
13.3 Disinfection ...................................................................................................................... 112
13.3.1 Disinfecting the Main Unit......................................................................................... 112
13.3.2 Disinfecting the Patient Cable.................................................................................... 112
13.3.3 Disinfecting the Reusable Electrodes......................................................................... 113
13.4 Care and Maintenance ...................................................................................................... 113
13.4.1 Recharge and Replacement of Battery....................................................................... 113
13.4.2 Recorder Paper ........................................................................................................... 114
13.4.3 Visual Inspection........................................................................................................ 115
13.4.4 Maintenance of the Main Unit and the Patient Cable ................................................ 115
Chapter 14 Accessories .............................................................................................................. 117
14.1 Standard Accessories ........................................................................................................ 117
14.2 Optional Accessories ........................................................................................................ 117
Chapter 15 Warranty & Service ............................................................................................... 119
15.1 Warranty............................................................................................................................ 119
15.2 Contact information.......................................................................................................... 119
Appendix 1 Technical Specifications ........................................................................................ 120
A1.1 Safety Specifications ....................................................................................................... 120
A1.2 Environment Specifications............................................................................................. 121
A1.3 Physical Specifications .................................................................................................... 121
A1.4 Power Supply Specifications ........................................................................................... 121
A1.5 Performance Specifications ............................................................................................. 122
Appendix 2 EMC Information.................................................................................................. 125
Appendix 3 Abbreviation........................................................................................................... 130
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Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of SE-1200 series
electrocardiograph.
1.1 Indications for Use/Intended Use
The intended use of SE-1200 series electrocardiograph is to acquire ECG signals from adult and
pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended
to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The
cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart
disease. However, the interpreted ECG with measurements and interpretive statements is offered
to clinicians on an advisory basis only.
WARNING
1. This equipment is not designed for intracardiac use or direct cardiac application.
2. This equipment is not intended for home use.
3. This equipment is not intended for treatment or monitoring.
4. This equipment is intended for use on adult and pediatric patients only.
5. The results given by the equipment should be examined based on the overall clinical
condition of the patient, and they cannot substitute for regular checking.
1.2 Warnings and Cautions
In order to use the electrocardiograph safely and effectively, and avoid possible dangers caused
by improper operation, please read through the user manual and be sure to be familiar with all
functions of the equipment and proper operation procedures before use.
Please pay more attention to the following warning and caution information.
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1.2.1 Safety Warnings
WARNING
1. The electrocardiograph is intended to be used by qualified physicians or personnel
professionally trained. They should be familiar with the contents of this user manual
before operation.
2. Only qualified service engineers can install this equipment, and only service
engineers authorized by the manufacturer can open the shell. Otherwise, safety
hazards may happen.
3. EXPLOSION HAZARD - Do not use the electrocardiograph 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. This equipment must
only be connected to a supply mains with protective earth
5. Make sure that the power is turned off and the power cord is disconnected from the
AC socket before connecting or disconnecting equipment. Otherwise, electrical
shock or other injuries may happen to the patient or operator.
6. If the integrity of the external protective conductor is in doubt, the equipment should
be powered by an internal li-ion rechargeable battery.
7. Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.
8. 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.
9. The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
10. The electrocardiograph has been safety tested with the recommended accessories,
peripherals, and leads, and no hazard is found when the electrocardiograph is
operated with cardiac pacemakers or other stimulators.
11. Make sure that all electrodes are connected to the patient correctly before operation.
12. 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.
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WARNING
13. If reusable electrodes with electrode gel are used during defibrillation, the
electrocardiograph recovery will take more than 10 seconds. The manufacturer
recommends the use of disposable electrodes at all times.
14. Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.
15. The disposable electrodes can only be used for one time.
16. Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.
17. Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously.
18. Do not touch the signal input or output connector and the patient simultaneously.
19. The use of equipment that applies high frequency voltages to the patient (including
electrosurgical equipment and some respiration transducers) is not supported and
may produce undesired results. Disconnect the patient data cable from the
electrocardiograph, or detach the leads from the patient prior to performing any
procedure that uses high frequency surgical equipment.
20. If WIFI technology is used, in order to maintain compliance with the FCC RF
exposure guidelines, WIFI should be installed and operated with a minimum distance
of 20cm between the radiator and the human body. There should be no shield in or
around the room where WIFI is used.
21. Fix attention on the examination to avoid missing important ECG waves.
22. 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.
23. 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.
24. Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1-1 approved to the electrocardiograph.
The operation or use of non-approved equipment or accessories with the
electrocardiograph is not tested or supported, and electrocardiograph operation and
safety are not guaranteed.
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WARNING
25. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
26. Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
27. Multiple portable socket-outlets shall not be placed on the floor.
28. 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.
29. Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the standard IEC/EN 60601-1-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN 60601-1-1. If in
doubt, consult our technical service department or your local distributor.
30. Connecting any accessory (such as external printer) or other device (such as the
computer) to this electrocardiograph makes a medical system. In that case,
additional safety measures should be taken during installation of the system, and the
system shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
31. 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.
32. You should purchase computer, printer, treadmill, ergometer and BP monitor from the
manufacturer. Otherwise, the manufacturer will not be held responsible for the
maintenance of the PC hardware, operating system and other accessories.
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WARNING
33. 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.
34. The potential equalization bar can be connected to that of other equipment when
necessary. Make sure that all the equipment is connected to the potential
equalization terminal.
35. The electrocardiograph shall not be serviced or maintained while in use with a
patient.
36. The appliance coupler or mains plug is used as isolation means from supply mains.
Position the electrocardiograph in a location where the operator can easily access
the disconnection device.
37. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC Information.
38. 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.
39. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information.
40. Assembly of the electrocardiograph and modifications during actual service life shall
be evaluated based on the requirements of IEC60601-1.
1.2.2 Li-ion Battery Care Warnings
WARNING
1. Improper operation may cause the internal li-ion battery (hereinafter called battery) to
be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It
is necessary to read the user manual carefully and pay more attention to warning
messages.
2. Only qualified service engineers authorized by the manufacturer can open the battery
compartment and replace the battery, and batteries of the same model and
specification as manufacturer configuration should be used.
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WARNING
3. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
4. Do not heat or splash the battery or throw it into fire or water.
5. Do not destroy the battery; Do not pierce battery with a sharp object such as a needle;
Do not hit with a hammer, step on or throw or drop to cause strong shock; Do not
disassemble or modify the battery.
6. When leakage or foul smell is found, stop using the battery immediately. If your skin
or cloth comes into contact with the leakage liquid, cleanse it with clean water at
once. If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them
with clean water first and go to see a doctor immediately.
7. Properly dispose of or recycle the depleted battery according to local regulations.
8. Only when the device is off can the battery be installed or removed.
9. Remove the battery from the electrocardiograph when the electrocardiograph isn’t
used for a long time.
10. If the battery is stored alone and not used for a long time, we recommend that the
battery be charged at least once every 6 months to prevent overdischarge.
1.2.3 General Cautions
CAUTION
1. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
2. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.
3. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
4. 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.
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CAUTION
5. Ruptured fuse must only be replaced with that of the same type and rating as the
original.
6. 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.
1.3 List of Symbols
No. Symbol Description
1 Output
2 Input
3
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
4
Attention, consult ACCOMPANYING DOCUMENTS
5 Operating instructions
6
Equipotential grounding
7 Patient Cable Socket
8 USB socket
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9 Net port
10 Alternating Current
11
Battery check
12 Battery recharging indicator
13
Delete key
14 Enter key
15 Esc key/Reset key
16 Shift key
17 Fn key
18
Power On/Off key
19 1mV/COPY key
20 MODE key
21
SLEEP/WAKE UP key
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22
PRINT/STOP key
23
Tab key/Feed paper key
24 UP/DOWN Arrow key
25 LEFT/RIGHT Arrow key / Lead switch key
26 Gender key
27 Age Group key
28 General symbol for recovery/recyclable
29 Part Number
30 SERIAL NUMBER
31
Date of manufacture
32
MANUFACTURER
33
AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY
34 CE marking
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35*
With respect to electrical shock, fire and mechanical hazards
only in accordance with UL 60601-1 and CAN/CSA C22.2 No.
601.1
36
Caution: Federal (U.S.) law restricts this device to sale by or on
the order of a physician.
37 Disposal method
38
Refer to User Manual
(Background: Blue; Symbol: White)
39
Warning
(Background: Yellow; Symbol&Outline: Black)
40
Non- ionizing electromagnetic radiation
NOTE:
1. *The UL mark is optional.
2. The user manual is printed in black and white.
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SE-1200 Series Electrocardiograph User Manual Introduction
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Chapter 2 Introduction
SE-1200 series electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the
operation menu, ECG parameters as well as electrocardiograms.
The 12-channel ECG waves can be viewed on the LCD screen and printed out by using a
high-quality thermal recorder. The sampled ECG data can be saved, transmitted and exported.
The manual, auto, rhythm, R-R analysis or VCG (only configurable for SE-1200 Express) mode
can be chosen freely.
SE-1200 series electrocardiograph can be powered by the mains supply or battery.
With a high resolution thermal recorder, a 32-bit processor and a large-capacity memorizer,
SE-1200 series electrocardiograph has advanced performance and high reliability. The compact
size makes it suitable for clinic and hospital uses.
SE-1200 series electrocardiograph has two models: SE-1200 and SE-1200 Express.
SE-1200 adopts 320×240 dot single color LCD screen; SE-1200 Express adopts 800×600
multicolor LCD screen.
Configuration: main unit, power cord, patient cable, chest electrodes, limb electrodes, disposable
electrodes, alligator clips, thermal recorder paper, fuses, battery.
NOTE: The pictures and windows in this manual are for reference only.
2.1 Top Panel
Figure 2-1 SE-1200 Express
LCD Screen
Recorder
Keyboard
Indicators
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Figure 2-2 SE-1200
2.2 Keyboard and Keys
Figure 2-3 SE-1200 Express/SE-1200 Keyboard
LCD Screen
Recorder
Keyboard
Indicators
A
C
E
M L KGI H
F
G
N
O
P
B
D
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