EDAN SE-1201 User Manual
I
About this Manual
P/N: 01.54.455318-10
Release Date: November 2011
© Copyright EDAN INSTRUMENTS, INC. 2011. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User’s operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.
II
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE: A NOTE provides useful information regarding a function or a procedure.
III
Table of Contents
Chapter 1 Safety Guidance ...........................................................................................................1
1.1 Intended Use ........................................................................................................................... 1
1.2 Warnings and Cautions ...........................................................................................................1
1.2.1 Safety Warnings ...............................................................................................................1
1.2.2 Li-ion Battery Care Warnings ..........................................................................................4
1.2.3 General Cautions.............................................................................................................. 5
1.3 List of Symbols....................................................................................................................... 6
Chapter 2 Introduction..................................................................................................................9
2.1 Top Panel ................................................................................................................................ 9
2.2 Keyboard and Keys ..............................................................................................................10
2.3 Rear Panel............................................................................................................................. 12
2.4 Right Panel ...........................................................................................................................13
2.5 Bottom Panel ........................................................................................................................16
2.6 Function Features .................................................................................................................17
Chapter 3 Operation Preparations.............................................................................................19
3.1 Connecting the Patient Cable to the Electrocardiograph and Electrodes ............................. 19
3.1.1 Connecting the Patient Cable to the Electrocardiograph ............................................... 19
3.1.2 Connecting the Patient Cable to Electrodes................................................................... 20
3.2 Preparing the Patient............................................................................................................. 20
3.2.1 Instructing the Patient ....................................................................................................20
3.2.2 Preparing the Skin.......................................................................................................... 21
3.3 Attaching Electrodes to the Patient.......................................................................................21
3.3.1 Electrode Placement....................................................................................................... 21
3.3.2 Attaching the Reusable Electrodes................................................................................. 23
3.3.2.1 Attaching the Limb Electrodes ................................................................................ 23
3.3.2.2 Attaching the Chest Electrodes................................................................................ 24
3.3.3 Attaching the Disposable Electrodes..............................................................................25
3.4 Inspection Before Power-On ................................................................................................ 25
3.5 Turning On/Off the Electrocardiograph................................................................................ 26
3.6 Loading/Replacing Recorder Paper...................................................................................... 28
Chapter 4 Basic Operation Guidance ........................................................................................31
4.1 Navigation Tips.....................................................................................................................31
4.1.1 Selecting Menu Functions.............................................................................................. 31
4.1.2 Entering Data .................................................................................................................32
4.1.3 Selecting an Item............................................................................................................ 33
IV
4.2 Configuring the Electrocardiograph ..................................................................................... 33
4.3 Screen Description................................................................................................................ 34
4.3.1 About the Main Screen................................................................................................... 34
4.3.2 About the System Setup Screen .....................................................................................37
4.3.3 About the Order Manager Screen...................................................................................38
4.3.4 About the File Manager Screen...................................................................................... 39
4.4 Work Mode Description........................................................................................................42
Chapter 5 Entering Patient Information...................................................................................43
5.1 Entering Patient Information Manually................................................................................ 43
5.2 Entering Patient Information by Using a Bar Code Reader (Optional)................................ 44
5.3 Entering Patient Information by Acquiring Orders ..............................................................45
Chapter 6 Printing ECG Reports ...............................................................................................47
6.1 Printing an ECG Report........................................................................................................ 47
6.1.1 Auto Mode...................................................................................................................... 47
6.1.2 Manual Mode ................................................................................................................. 48
6.1.3 Rhythm Mode................................................................................................................. 49
6.1.4 R-R Analysis Mode........................................................................................................ 50
6.1.5 Review Printing.............................................................................................................. 51
6.2 Copy Printing........................................................................................................................ 51
6.3 Freezing ECG Waves............................................................................................................ 52
6.4 Printing a Stored ECG Report .............................................................................................. 53
6.4.1 Printing on the File Manager Screen1/2......................................................................... 53
6.4.2 Printing on the Preview Screen...................................................................................... 53
6.5 Sample ECG Reports............................................................................................................ 54
6.5.1 ECG Reports in the Auto Mode..................................................................................... 54
6.5.2 ECG Reports in the Rhythm Mode ................................................................................ 58
6.5.3 ECG Reports in the Manual Mode................................................................................. 59
6.5.4 ECG Reports in the R-R Analysis Mode........................................................................60
6.5.5 ECG Reports Printed by the USB Printer ...................................................................... 63
6.5.6 ECG Report of Patient with Pacemaker......................................................................... 64
6.5.7 ECG Report of Nehb Lead............................................................................................. 65
Chapter 7 Transmitting ECG Data.............................................................................................66
7.1 Transmitting ECG Data to the PC ........................................................................................66
7.1.1 Transmitting ECG Data in DAT Format through Ethernet Cable.................................. 66
7.1.2 Transmitting ECG Data in SCP/FDA-XML/PDF Format through Ethernet Cable....... 68
7.2 Real-time Transmission to PC ECG ..................................................................................... 69
Chapter 8 Managing Orders.......................................................................................................71
V
8.1 Loading Orders ..................................................................................................................... 71
8.2 Examining Orders.................................................................................................................72
8.3 Deleting Orders..................................................................................................................... 72
8.4 Searching Orders ..................................................................................................................73
8.5 Setting Orders ....................................................................................................................... 73
8.5.1 Factory Defaults of Orders............................................................................................. 73
8.5.2 Order Setup .................................................................................................................... 74
Chapter 9 Managing Files...........................................................................................................76
9.1 Transmitting Files................................................................................................................. 77
9.2 Exporting Files .....................................................................................................................77
9.3 Deleting Files........................................................................................................................ 78
9.4 Searching Files .....................................................................................................................78
9.5 Importing Files .....................................................................................................................79
9.6 Editing Patient Information .................................................................................................. 79
9.7 Printing Files......................................................................................................................... 79
9.8 Previewing a File .................................................................................................................. 80
Chapter 10 System Setup.............................................................................................................82
10.1 Factory Defaults .................................................................................................................82
10.2 Work Mode Setup ............................................................................................................... 86
10.3 Filter Setup .........................................................................................................................88
10.4 Record Info Setup............................................................................................................... 89
10.4.1 Setup 1.......................................................................................................................... 89
10.4.2 Setup 2.......................................................................................................................... 94
10.5 Patient Information Setup................................................................................................... 95
10.6 Transmission Setup............................................................................................................. 97
10.7 Lead Setup .......................................................................................................................... 98
10.8 Display&Sound Setup ........................................................................................................99
10.9 Date&Time Setup ............................................................................................................. 101
10.10 File Setup........................................................................................................................ 102
10.11 System Maintenance Setup............................................................................................. 104
10.12 Other Setup ..................................................................................................................... 105
Chapter 11 Hint Information....................................................................................................107
Chapter 12 Troubleshooting......................................................................................................108
Chapter 13 Cleaning, Care and Maintenance.........................................................................112
13.1 Cleaning............................................................................................................................ 112
13.1.1 Cleaning the Main Unit and the Patient Cable........................................................... 112
13.1.2 Cleaning the Reusable Electrodes.............................................................................. 112
VI
13.1.3 Cleaning the Print Head ............................................................................................. 113
13.2 Disinfection ...................................................................................................................... 113
13.3 Care and Maintenance ...................................................................................................... 113
13.3.1 Recharge and Replacement of Battery....................................................................... 114
13.3.2 Recorder Paper........................................................................................................... 115
13.3.3 Visual inspection ........................................................................................................ 115
13.3.4 Maintenance of the Main Unit and the Patient Cable ................................................ 116
Chapter 14 Accessories ..............................................................................................................118
14.1 Standard Accessories ........................................................................................................ 118
14.2 Optional Accessories ........................................................................................................ 118
Chapter 15 Warranty & Service...............................................................................................120
15.1 Warranty............................................................................................................................ 120
15.2 Contact information.......................................................................................................... 120
Appendix 1 Technical Specifications........................................................................................121
A1.1 Safety Specifications .......................................................................................................121
A1.2 Environment Specifications............................................................................................. 121
A1.3 Physical Specifications .................................................................................................... 122
A1.4 Power Supply Specifications ........................................................................................... 122
A1.5 Performance Specifications ............................................................................................. 123
Appendix 2 EMC Information..................................................................................................125
Appendix 3 Abbreviation...........................................................................................................130
SE-1201 Electrocardiograph User Manual Safety Guidance
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Chapter 1 Safety Guidance
This chapter provides important safety information related to the use of the 12-channel
electrocardiograph.
1.1 Intended Use
The intended use of SE-1201 12-channel electrocardiograph (hereinafter called SE-1201) 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 internal 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 can not 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.
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.
SE-1201 Electrocardiograph User Manual Safety Guidance
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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.
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.
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 can not be guaranteed.
9. Make sure that all electrodes are connected to the patient correctly before operation.
10. 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.
11. 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.
12. Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.
13. The disposable electrodes can only be used for one time.
14. 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.
15. Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.
16. Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously.
SE-1201 Electrocardiograph User Manual Safety Guidance
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WARNING
17. 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.
18. If the wireless AP technology is used, in order to maintain compliance with the FCC
RF exposure guidelines, the wireless AP 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 the wireless AP is used.
19. Fix attention on the examination to avoid missing important ECG waves.
20. 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.
21. 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.
22. 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.
23. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
24. Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
25. Multiple portable socket-outlets shall not be placed on the floor.
26. 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.
27. 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.
SE-1201 Electrocardiograph User Manual Safety Guidance
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WARNING
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.
28. Parts and accessories used must meet the requirements of the applicable IEC/EN
601 series safety standards, and/or the system configuration must meet the
requirement of the IEC/EN 60601-1-1 medical electrical systems standard.
29. 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.
30. 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.
31. 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.
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 should be used.
3. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
SE-1201 Electrocardiograph User Manual Safety Guidance
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WARNING
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. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.
2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
3. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.
4. Ruptured fuse must only be replaced with that of the same type and rating as the
original.
SE-1201 Electrocardiograph User Manual Safety Guidance
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CAUTION
5. The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of
them together with house-hold garbage. At the end of their lives hand the batteries
over to the applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or battery, please contact your
local Civic Office, or the shop where you purchased the product.
6. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
1.3 List of Symbols
External output
External input
Equipment or part of CF type with defibrillator proof
Caution
Consult Instructions for Use
Potential equalization
Patient Cable Socket
SD Card port
USB port
Net port
SE-1201 Electrocardiograph User Manual Safety Guidance
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Mains supply
Battery indicator
Battery recharging indicator
Enter key
Delete key
Esc key
RESET key
Shift key
Fn key
Power On/Off key
1mV/COPY key
MODE key
PRINT/STOP key
Tab key
FEED Paper key
Lead switch key/LEFT/RIGHT Arrow key
SE-1201 Electrocardiograph User Manual Safety Guidance
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UP/DOWN Arrow key
REVIEW key
Gender key
Age Group key
Recycle
Part Number
Serial Number
Date of Manufacture
Manufacturer
Authorized Representative in the European Community
The symbol indicates that the device complies with the
European Council Directive 93/42/EEC concerning
medical devices.
Rx only (U.S.)
Federal (US) law restricts this device to sale by or on the
order of a physician.
It indicates that the device should be sent to the special
agencies according to local regulations for separate
collection after its useful life.
SE-1201 Electrocardiograph User Manual Introduction
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Chapter 2 Introduction
SE-1201 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 off mode can be chosen freely.
SE-1201 can be powered by the mains supply or the battery.
With a high resolution thermal recorder, a 32-bit processor and a large-capacity memorizer,
SE-1201 has advanced performance and high reliability. The compact size makes it suitable for
clinic and hospital uses.
SE-1201 adopts 800×480 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-1201
Keyboard
LCD Screen
Recorder
Indicators
From left to
right on the top
panel: A, B, C.
SE-1201 Electrocardiograph User Manual Introduction
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Symbol Name Explanation
A
Mains supply
indicator
When the device is powered by the mains supply,
this indicator is lit.
B
Battery indicator
When the device is powered by the battery, this
indicator is lit.
C
Battery recharging
indicator
When the device is powered on, the indicator
flashes for a few seconds.
When the battery is being recharged, this indicator
is lit.
2.2 Keyboard and Keys
Figure 2-2 SE-1201 Keyboard
E
A
B
C
L K
J
I
H
F
D
Q
O
P
N
M
G
R
SE-1201 Electrocardiograph User Manual Introduction
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Name Explanation
A Function Key Press to select menu functions on the screen.
B Gender Key
Press to select the gender for the patient when Gender is
selected in the Patient Information Setup window.
C Age Group Key
Press to select the age group on the main screen when you set
Age to Age Group in the Patient Information Setup window.
D Delete Press to erase characters.
E Enter Press to confirm operation.
F Arrow Keys
Moving the cursor (Up, Down, Left, Right).
In the manual mode, press the Left or Right arrow to switch
among the lead groups.
Pressing Shift + Up/Down can turn pages on the Order
Manager screen and the File Manager screen.
G REVIEW
10s ECG data sampled before pressing the REVIEW key will
be printed out in the AUTO mode.
NOTE: The system will not respond to the REVIEW key
unless 10s data has been collected on the main screen.
H PRINT/STOP Press to start or stop printing reports
I 1mV/COPY
In the manual mode, pressing the 1mV/COPY key can insert a
1mV calibration mark in the printing course.
In the auto or rhythm mode, pressing the 1mV/COPY key can
print the ECG report which was printed out last time.
J RESET
Press to reset the baseline.
NOTE: A large polarization voltage may cause baseline
drift. On the main screen, pressing the RESET key can
decrease the polarization voltage and draw the baseline to
zero quickly.
K FEED Paper
When the main screen, the freezing screen, the File Manager
screen1/2 or the preview screen is displayed, if Paper Marker
is set to Yes, you can press the FEED key to advance the
recorder paper to the next black marker; if Paper Marker is set
to No, you can press the FEED key to advance the paper for
2.5cm. Press the FEED key again to stop advancing the paper.
SE-1201 Electrocardiograph User Manual Introduction
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L MODE
Press to select a working mode among the auto, manual,
rhythm, R-R analysis and off modes.
NOTE: Only if a working mode is selected in the Work
Mode Setup window, can the working mode be selected
by pressing the MODE key when the main screen is
displayed.
M Space
Press to add a space between typed characters or select/deselect
a checkbox
N Shift
Press Shift and a numeric key to input the special character in
the top left corner of the key.
If Caps Lock is set to Off, pressing Shift + P can type a capital
P.
If Caps Lock is set to On, pressing Shift + P can type a
lowercase p.
O Tab
Press to move the cursor.
Pressing Tab can move the cursor forward, and pressing Shift +
Tab can move the cursor backward.
P Fn
Press Fn and a letter key to type special characters.
Pressing Fn + a can type è.
Q Esc Press to cancel operation or return to the previous screen.
R Power On/Off Power-on/Power-off
2.3 Rear Panel
Figure 2-3 SE-1201 Rear Panel
A
B
D
C
E
SE-1201 Electrocardiograph User Manual Introduction
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Name Explanation
A
Potential Equalization
Conductor
Potential equalization conductor provides a
connection between the unit and the potential equalization
bus bar of the electrical installation.
B Mains Supply Socket AC SOURCE: alternating current supply socket
C Handle Part for people to hold
D Heat Emission Hole Path for internal heat emission
E Fuse The specification is: T3.15AH 250V Ø5×20
2.4 Right Panel
Figure 2-4 SE-1201 Right Panel
Name Explanation
A Patient Cable Socket Connecting to the patient cable
B SD Card Socket Connecting to SD card
C USB Socket 1/2
Standard USB Host socket, connecting to a U disk,
a bar code reader or a USB printer recommended by
the manufacturer
D USB Socket 3 Standard USB Device socket, connecting to a PC.
E External Input / Output Socket Connecting to the external signal device
F Net port Standard net port, connecting to a PC
C
A
E
F
C
B
D
SE-1201 Electrocardiograph User Manual Introduction
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1) Patient Cable Socket
: Applied part of type CF with defibrillator proof
: Caution
Definitions of corresponding pins:
Pin Signal Pin Signal Pin Signal
1
C2 (input)/
V2 (input)
6
SH
11
F (input)/
LL (input)
2
C3 (input)/
V3 (input)
7
NC
12
C1 (input) / V1 (input)
or NC
3
C4 (input)/
V4 (input)
8
NC
13
C1(input) /
V1 (input)
4
C5 (input)/
V5 (input)
9
R(input) /
RA (input)
14
RF (N) (input)/
RL (input) or NC
5
C6 (input)/
V6 (input)
10
L (input)/
LA (input)
15
RF (N) (input)/
RL (input)
NOTE: The left side of “/” is European standard, and the right side is American standard.
2) SD Socket
SE-1201 Electrocardiograph User Manual Introduction
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Definitions of corresponding pins:
Pin Signal Pin Signal Pin Signal
1
CD DAT3
5
CLK
9
DAT2
2
CMD
6
Vss
10
CD
3
Vss
7
DAT0
11
WP
4
Vcc
8
DAT1
3) USB Socket 1/USB Socket 2/USB Socket 3
CAUTION
Only the USB equipment recommended by the manufacturer can be connected to the
USB socket 1/2.
Definitions of corresponding pins:
Pin Signal Pin Signal
1
+5V
3
D+
2
D-
4
GND
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 60601-1-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN 60601-1-1. If in
doubt, consult our technical service department or your local distributor.
2. If multiple instruments are connected to a patient, the sum of the leakage currents
may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
Consult your service personnel.
SE-1201 Electrocardiograph User Manual Introduction
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4) External Input/Output Socket
Definitions of corresponding pins:
Pin Signal Pin Signal
1
GND
4
GND
2
GND
5
ECG Signal (input)
3
GND
6
ECG Signal (output)
2.5 Bottom Panel
Figure 2-5 SE-1201 Bottom Panel
Name Explanation
A Speaker Hole Path for sound from speaker
B Battery Compartment Compartment for the battery
C Heat Emission Hole Path for internal heat emission
D Label Position for product information label
B
D
A
C
SE-1201 Electrocardiograph User Manual Introduction
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1) Battery Compartment
Rated Voltage: 14.8V
Rated Capacity: 2200mAh
WARNING
1. Improper operation may cause the battery to be hot, ignited or exploded, and it may
lead to the decrease of the battery capacity. Therefore, it is necessary to read the
user manual carefully and pay more attention to warning messages.
2. 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.
3. 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 must be used.
4. Only when the device is off can the battery be installed or removed.
NOTE: If the battery has not been used for two months or more, you should recharge it
before using it again.
2) Fuse
There are two fuses of the same specification installed on the bottom of the main unit. The
specification is: T3.15AH 250V Ø5×20.
WARNING
Ruptured fuses must only be replaced with those of the same type and rating as the
original.
2.6 Function Features
♦ Supporting AC and DC power supply modes, internal rechargeable li-ion battery with
professional battery powered circuit, battery management and protection systems
♦ Supporting multi-language
♦ Full alphanumeric keyboard (touch screen is optional)
♦ ECG signals of 12 leads are gathered and amplified simultaneously, 12-channel waves
are displayed and recorded simultaneously
♦ Correct detection for failure electrodes
♦ Convenient operation of recording by pressing the PRINT/STOP key with high
efficiency
SE-1201 Electrocardiograph User Manual Introduction
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♦ High resolution thermal recorder, recording frequency response ≤150Hz
♦ Supporting external USB printer
♦ Supporting accurate digital filter to decrease the polarization voltage and other
interferences
♦ Supporting folded paper recorded with high resolution waveforms, calibration mark,
gain, speed and filter
♦ The auto, manual, rhythm, R-R analysis and off modes can be chosen freely
♦ Flexible printing formats
♦ Supporting ECG waves displaying with grid.
♦ Automatic baseline adjustment for optimal printing
♦ Convenient operation of system setup and file management
♦ Multiple file formats: DAT/SCP (optional) /FDA-XML (optional) /PDF
♦ Measurement function and interpretation function
♦ Supporting bar code reader
♦ ECG data can be transmitted to the PC software through the net cable, or wireless AP
(optional).
♦ Real-time transmission to PC ECG
♦ Supporting order function
SE-1201 Electrocardiograph User Manual Operation Preparations
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Chapter 3 Operation Preparations
WARNING
Before use, the equipment, patient cable and electrodes should be checked. Replace
them if there is any evident defectiveness or aging which may impair the safety or the
performance, and make sure that the equipment is in proper working condition.
3.1 Connecting the Patient Cable to the Electrocardiograph
and Electrodes
WARNING
The performance and electric shock protection can be guaranteed only if the original
patient cable and electrodes of the manufacturer are used.
The patient cable includes the main cable and lead wires which can be connected to electrodes.
3.1.1 Connecting the Patient Cable to the Electrocardiograph
Connect the patient cable to the patient cable socket on the right side of the main unit, and then
secure them with two screws.
Main Cable
Lead Wires
Connecting to the
Electrocardiograph
Screw
Electrode Connector
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3.1.2 Connecting the Patient Cable to Electrodes
Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the
reusable electrodes or the alligator clips. Firmly attach them.
The identifiers and color codes of electrode connectors used comply with IEC/EN requirements.
In order to avoid incorrect connection, the identifiers and color codes are specified in Table 3-1.
Moreover the equivalent codes according to American requirements are given in Table 3-1 too.
Table 3-1 Electrode Connectors and Their Identifiers and Color Codes
European American
Electrode Connectors Identifier Color Code Identifier Color Code
Right arm/Right deltoid R Red RA White
Left arm/Left deltoid L Yellow LA Black
Right leg/Upper leg as
close to torso as possible
N or RF Black RL Green
Left leg/Upper leg as
close to torso as possible
F Green LL Red
Chest 1 C1 White/Red V1 Brown/Red
Chest 2 C2 White/Yellow V2 Brown/Yellow
Chest 3 C3 White/Green V3 Brown/Green
Chest 4 C4 White/Brown V4 Brown/Blue
Chest 5 C5 White/Black V5 Brown/Orange
Chest 6 C6 White/Violet V6 Brown/Violet
3.2 Preparing the Patient
3.2.1 Instructing the Patient
Before attaching the electrodes, greet the patient and explain the procedure. Explaining the
procedure decreases the patient’s anxiety. Reassure the patient that the procedure is painless.
Privacy is important for relaxation. When possible, prepare the patient in a quiet room or area
where others can’t see the patient. Make sure that the patient is comfortable. The more relaxed
the patient is, the less the ECG will be affected by noise.
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3.2.2 Preparing the Skin
Thorough skin preparation is very important. The skin is a poor conductor of electricity and
frequently creates artifacts that distort the ECG signals. By performing methodical skin
preparation, you can greatly reduce the possibility of noise caused by muscle tremor and baseline
drift, ensuring high-quality ECG waves. There is natural resistance on the skin surface due to dry,
dead epidermal cells, oils and dirt.
To Prepare 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 with a gauze pad to increase capillary blood flow to the tissues and to remove the
dead, dry skin cells and oils.
3.3 Attaching Electrodes to the Patient
Two kinds of electrode can be used, one is the reusable electrode (including chest electrodes and
limb electrodes), and the other is the disposable electrode.
WARNING
1. Make sure that all electrodes are connected to the patient correctly before operation.
2. 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.
3.3.1 Electrode Placement
The electrodes’ positions on the body surface are shown in the following table and figure.
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Standard 12-Lead Placement
Only for the Reusable Electrodes
European
Label
American
Label
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
Right arm/Right deltoid
R RA
Left arm/Left deltoid
F LL
Right leg/Upper leg as close to torso as possible
N RL
Left leg/Upper leg as close to torso as possible
Only for the Disposable Electrodes
SE-1201 Electrocardiograph User Manual Operation Preparations
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NEHB Placement
European
Label
American
Label
Electrode Placement
Nst A1 Attachment point of the second rib to the right sternal edge
Nax A2 Fifth intercostal space on the left posterior axillary line
Nap V4 Left mid-clavicular line in the fifth intercostal space
R RA Right arm
L LA Left arm
N or RF RL Right leg
F LL Left leg
3.3.2 Attaching the Reusable Electrodes
3.3.2.1 Attaching the Limb Electrodes
Limb Electrode
Reed
Connecting to a Lead Wire
Clamp
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