EDAN INSTRUMENTS
Electrocardiographs
Model SE-12, SE-12 Express User Manual Release 1.4 with sw rev 1.8
User Manual
170 Pages
Preview
Page 1
About this Manual P/N: 01.54.106764-14 Release Date: July 2010 © Copyright EDAN INSTRUMENTS, INC. 2007-2010. All rights reserved.
Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual.
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 persons authorized by EDAN, and I
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.
II
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 Battery Care Warnings ..................................................................................................... 3 1.2.3 General Cautions.............................................................................................................. 4 1.2.4 Cleaning & Disinfection Cautions ................................................................................... 6 1.3 List of Symbols....................................................................................................................... 6 Chapter 2 Introduction.................................................................................................................. 9 2.1 Top Panel .............................................................................................................................. 10 2.2 Keyboard and Keys .............................................................................................................. 11 2.3 Front Panel............................................................................................................................ 13 2.4 Rear Panel............................................................................................................................. 14 2.5 Right Panel ........................................................................................................................... 14 2.6 Bottom Panel ........................................................................................................................ 18 2.7 Function Features ................................................................................................................. 20 Chapter 3 About the Electrocardiograph Application.............................................................. 21 3.1 Selecting Menu Functions .................................................................................................... 21 3.2 Entering Data........................................................................................................................ 22 3.3 Selecting an Item .................................................................................................................. 23 3.4 About the Main Interface ...................................................................................................... 24 3.5 About the System Setup Interface ........................................................................................ 26 3.6 About the File Manager Interface ......................................................................................... 28 Chapter 4 Operation Preparations............................................................................................. 31 4.1 Power and Earthing .............................................................................................................. 31 4.2 Loading/Replacing Recorder Paper...................................................................................... 32 4.3 Preparing the Patient............................................................................................................. 36 4.3.1 Instructing the Patient .................................................................................................... 36 4.3.2 Preparing the Skin .......................................................................................................... 37 4.4 Connecting the Patient Cable to the Electrocardiograph and Electrodes ............................. 37 4.5 Attaching Electrodes to the Patient....................................................................................... 38 4.5.1 Lead Placement .............................................................................................................. 38 4.5.2 Electrode Placement....................................................................................................... 40 4.6 Inspection Before Power-On ................................................................................................ 43 III
Chapter 5 Turning On the Electrocardiograph......................................................................... 45 Chapter 6 Entering Patient Information ................................................................................... 46 6.1 Entering Patient ID ............................................................................................................... 46 6.2 Entering Other Information .................................................................................................. 47 6.3 Using a Bar Code Reader ..................................................................................................... 49 Chapter 7 Freezing ECG Waves ................................................................................................. 53 Chapter 8 Printing ECG Reports ............................................................................................... 55 8.1 Auto Mode ............................................................................................................................ 55 8.2 Manual Mode........................................................................................................................ 59 8.3 Rhythm Mode ....................................................................................................................... 61 8.4 R-R Analysis Mode .............................................................................................................. 63 8.5 Copy Printing........................................................................................................................ 65 8.6 ECG Reports......................................................................................................................... 66 8.6.1 ECG Reports in the Auto Mode ..................................................................................... 66 8.6.2 ECG Reports in the Rhythm Mode ................................................................................ 71 8.6.3 ECG Reports in the Manual Mode................................................................................. 72 8.6.4 ECG Reports in the R-R Analysis Mode........................................................................ 73 8.6.5 ECG Reports Printed by the USB Printer ...................................................................... 77 8.6.6 ECG Report of Patient with Pacemaker......................................................................... 78 8.6.7 ECG Report of Nehb Lead............................................................................................. 79 Chapter 9 Transmitting ECG Data Automatically.................................................................... 81 9.1 Transmitting ECG Data to the PC ........................................................................................ 81 9.1.1 Transmitting ECG Data in DAT Format Through Serial Cable ..................................... 81 9.1.2 Transmitting ECG Data in DAT Format Through Net Cable......................................... 83 9.1.3 Transmitting ECG Data in SCP/FDA-XML/PDF Format Through Net Cable ............. 85 9.2 Exporting ECG Data to the U Disk Automatically............................................................... 88 9.3 Real-time Transmission to PC ECG ..................................................................................... 89 Chapter 10 Managing Files ......................................................................................................... 91 10.1 Transmitting Files to the PC ............................................................................................... 93 10.1.1 Transmitting DAT Files Through Serial Cable ............................................................ 94 10.1.2 Transmitting DAT Files Through Net Cable ................................................................ 95 10.1.3 Transmitting SCP/FDA-XML/PDF Files Through Net Cable..................................... 96 10.2 Exporting Files to the U Disk ............................................................................................. 97 10.3 Deleting Files...................................................................................................................... 98 10.4 Searching Files ................................................................................................................... 99 IV
10.5 Importing Files ................................................................................................................. 100 10.6 Editing Patient Information .............................................................................................. 100 10.7 Printing Files..................................................................................................................... 101 10.8 Previewing a File .............................................................................................................. 101 Chapter 11 System Setup........................................................................................................... 105 11.1 Work Mode Setup ............................................................................................................. 105 11.1.1 Selecting Work Mode ................................................................................................. 106 11.1.2 Selecting Manual Style............................................................................................... 107 11.1.3 Selecting Rhythm Style .............................................................................................. 107 11.1.4 Selecting Auto Display Style...................................................................................... 107 11.1.5 Selecting Sampling Mode .......................................................................................... 108 11.1.6 Setting Interval and Duration ..................................................................................... 109 11.1.7 Selecting Preview Function........................................................................................ 109 11.1.8 Selecting Auto Extend Record ................................................................................... 109 11.2 Filter Setup........................................................................................................................ 109 11.2.1 Setting AC Filter......................................................................................................... 110 11.2.2 Setting DFT Filter ...................................................................................................... 110 11.2.3 Setting EMG Filter ..................................................................................................... 111 11.2.4 Setting Lowpass Filter................................................................................................ 111 11.3 Record Info Setup ............................................................................................................. 112 11.3.1 Setup 1........................................................................................................................ 112 11.3.2 Setup 2........................................................................................................................ 116 11.4 Patient Information Setup ................................................................................................. 117 11.4.1 Selecting First/Last Name / Gender / D.O.B / Height / Weight / BP / Race / Pacemaker / Medication / Room No. / Department / Physician / Technician / Ref-Physician................ 118 11.4.2 Selecting ID Mode ..................................................................................................... 119 11.4.3 Selecting ID Hint........................................................................................................ 119 11.4.4 Setting Prompt............................................................................................................ 119 11.4.5 Selecting H/W Unit .................................................................................................... 119 11.4.6 Selecting BP Unit ....................................................................................................... 120 11.4.7 Selecting Next Patient ................................................................................................ 120 11.4.8 Setting the Time to Clear Patient Information ........................................................... 121 11.4.9 Inputting Customized Information ............................................................................. 121 11.5 Transmission Setup........................................................................................................... 122 11.5.1 Setting Device No. ..................................................................................................... 123 11.5.2 Selecting Auto Transmission...................................................................................... 123 11.5.3 Selecting Transmission Mode .................................................................................... 123 11.5.4 Setting FTP Information............................................................................................. 124 V
11.5.5 Setting IP Addresses ................................................................................................... 124 11.6 Lead Setup ........................................................................................................................ 124 11.6.1 Setting Rhythm Lead1/2/3 ......................................................................................... 125 11.6.2 Setting Lead Sequence ............................................................................................... 126 11.6.3 Selecting Nehb ........................................................................................................... 126 11.7 Display&Sound Setup ...................................................................................................... 126 11.7.1 Setting Brightness (Optional)..................................................................................... 127 11.7.2 Selecting Display Colors (Only for SE-1200 Express).............................................. 127 11.7.3 Selecting Antialiasing................................................................................................. 127 11.7.4 Setting Key Volume.................................................................................................... 128 11.7.5 Setting Hint Volume ................................................................................................... 128 11.7.6 Setting QRS Volume .................................................................................................. 128 11.8 Date&Time Setup ............................................................................................................. 128 11.8.1 Setting Date and Time ................................................................................................ 129 11.8.2 Setting Date Mode...................................................................................................... 129 11.8.3 Setting Time Mode ..................................................................................................... 130 11.8.4 Setting Power-Off Time ............................................................................................. 130 11.8.5 Setting LCD Off Time................................................................................................ 130 11.9 File Setup .......................................................................................................................... 130 11.9.1 Selecting Auto Save ................................................................................................... 131 11.9.2 Setting Saving Path .................................................................................................... 131 11.9.3 Setting File Format..................................................................................................... 132 11.9.4 Selecting Deleting Files After Transmission or Export.............................................. 132 11.9.5 Selecting Replacing When Memory is Full ............................................................... 132 11.9.6 Selecting SCP File Compression................................................................................ 132 11.10 System Maintenance Setup............................................................................................. 133 11.10.1 Exporting System Settings to U Disk....................................................................... 133 11.10.2 Loading System Settings from U Disk..................................................................... 134 11.10.3 Backing Up Settings................................................................................................. 134 11.10.4 Loading Backup Settings ......................................................................................... 134 11.10.5 Printing System Settings .......................................................................................... 134 11.10.6 Loading Factory Settings ......................................................................................... 134 11.10.7 Setting System Password ......................................................................................... 137 11.11 Other Setup ..................................................................................................................... 138 11.11.1 Entering Institution................................................................................................... 138 11.11.2 Selecting a Language................................................................................................ 138 11.11.3 Selecting Caps Lock ................................................................................................. 139 11.11.4 Setting External Input............................................................................................... 139 VI
11.11.5 Setting External Output ............................................................................................ 139 11.11.6 Setting Pacemaker Detection Sensitivity ................................................................. 140 Chapter 12 Turning Off the Electrocardiograph .................................................................... 141 Chapter 13 Hint Information.................................................................................................... 142 Chapter 14 Cleaning, Care and Maintenance ......................................................................... 143 14.1 Cleaning............................................................................................................................ 143 14.1.1 Cleaning the Main Unit and the Patient Cable........................................................... 143 14.1.2 Cleaning the Reusable Electrodes.............................................................................. 143 14.1.3 Cleaning the Print Head ............................................................................................. 143 14.2 Disinfection ...................................................................................................................... 144 14.3 Care and Maintenance ...................................................................................................... 144 14.3.1 Recharge and Replacement of Battery ....................................................................... 144 14.3.2 Recorder Paper ........................................................................................................... 145 14.3.3 Maintenance of the Main Unit and the Patient Cable ................................................ 146 Chapter 15 Accessories .............................................................................................................. 148 Chapter 16 Warranty & Service Policy.................................................................................... 150 16.1 Warranty............................................................................................................................ 150 16.2 Service Policy ................................................................................................................... 150 Appendix 1 Technical Specifications ........................................................................................ 152 A1.1 Safety Specifications ....................................................................................................... 152 A1.2 Environment Specifications............................................................................................. 153 A1.3 Physical Specifications .................................................................................................... 153 A1.4 Power Supply Specifications ........................................................................................... 153 A1.5 Performance Specifications ............................................................................................. 154 Appendix 2 EMC Information.................................................................................................. 157 Appendix 3 Abbreviation........................................................................................................... 162
VII
12-Channel Electrocardiograph User Manual
Safety Guidance
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 the 12-channel 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.
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. Notes: 1 This device is not intended for home use. 2 The pictures and interfaces in this manual are for reference only.
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. -1-
12-Channel Electrocardiograph User Manual
Safety Guidance
WARNING 3
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.
4
This device is not intended for treatment.
5
EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of flammable anesthetic mixtures with oxygen or other flammable agents.
6
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.
7
If the integrity of the external protective conductor is in doubt, the equipment should be powered by a built-in rechargeable battery.
8
Do not use this equipment in the presence of high static electricity or high voltage equipment which may generate sparks.
9
This equipment is not designed for internal use or direct cardiac application.
10 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. 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. 13 Electrodes with defibrillator protection should be used while defibrillating. 14 If reusable electrodes with electrode gel are used during defibrillation, ECG recovery will take more than 10 seconds. The manufacturer recommends the use of disposable electrodes at all times. 15 Electrodes of dissimilar metals should not be used; otherwise it may cause a high polarization voltage. 16 To the patient with a pacemaker, the results given by the equipment may be invalid. 17 Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator.
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Safety Guidance
WARNING 18 In order to avoid being burnt, please keep the electrodes far away from the radio knife while using electrosurgical equipment. 19 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configuration shall comply with the valid version of the standard IEC/EN 60601-1-1. Therefore anybody, who connects additional equipment to the signal input or output connector to configure a medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or your local distributor. 20 The summation of leakage current should never exceed leakage current limits while several other units are used at the same time. 21 The potential equalization bar can be connected to that of other equipment when necessary. Make sure that all these devices are connected to the potential equalization terminal. 22 The equipment is protected against malfunctions caused by electrosurgery according to the clause 36.202.101 in the standard IEC 60601-2-25. 23 The disposable electrodes can only be used for one time. 24 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. Use the supplied antenna only. There should be no shield in or around the room where the wireless AP is used. 25 Fix attention on the examination to avoid missing important ECG waves.
1.2.2 Battery Care Warnings 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. It is necessary to read the user manual -3-
12-Channel Electrocardiograph User Manual
Safety Guidance
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.
4
Do not heat or splash the battery or throw it into fire or water.
5
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.
6
Only when the device is off can the battery be installed or removed.
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.
5
Before use, the equipment, patient cable and electrodes etc. should be checked. Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or the performance.
6
The following safety checks should be performed at least every 24 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests. -4-
12-Channel Electrocardiograph User Manual
Safety Guidance
CAUTION a)
Inspect the equipment and accessories for mechanical and functional damage.
b)
Inspect the safety related labels for legibility.
c)
Inspect the fuse to verify compliance with the rated current and circuit-breaking characteristics.
d)
Verify that the device functions properly as described in the instructions for use.
e)
Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm.
f)
Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 μA, SFC 1000μA.
g)
Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100μA, SFC 500μA.
h)
Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
i)
Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
j)
Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC/EN 60601-1: Limit: 50μA (CF).
The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired. 7
Ruptured fuse must only be replaced with that of the same type and rating as the original.
8
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.
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12-Channel Electrocardiograph User Manual
Safety Guidance
1.2.4 Cleaning & Disinfection Cautions CAUTION 1
Turn off the power before cleaning and disinfection. If the mains supply is used, the power cord should be dragged out of the outlet. Prevent the detergent from seeping into the equipment.
2
Do not immerse the unit or the patient cable into liquid under any circumstances.
3
Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes.
4
Any remainder of detergent should be removed from the unit and the patient cable after cleaning.
5
Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.
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
Mains supply
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Safety Guidance
USB port
Battery indicator
Battery recharging indicator Delete key Enter key
Esc key/Reset key
Shift key
Fn key
Power On/Off key
COPY key
MODE key
SLEEP/WAKE UP key
START/STOP key
Tab key/Feed paper key
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12-Channel Electrocardiograph User Manual
Safety Guidance
UP/DOWN/LEFT/RIGHT Arrow 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.
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12-Channel Electrocardiograph User Manual
Introduction
Chapter 2 Introduction The 12-channel 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 off mode can be chosen freely. The 12-channel electrocardiograph can be powered by the mains supply or a built-in rechargeable lithium battery. With a high resolution thermal recorder, a 32-bit processor and a large-capacity memorizer, the 12-channel electrocardiograph has advanced performance and high reliability. The compact size makes it suitable for clinic and hospital uses. The 12-channel 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, lithium battery. WARNING 1 This equipment is intended for use on adult and pediatric patients only. 2 This equipment is not designed for internal use or direct cardiac application. 3 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.
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12-Channel Electrocardiograph User Manual
Introduction
2.1 Top Panel Indicators
LCD Screen
Recorder
Keyboard
Figure 2-1 SE-1200 Express Indicators
LCD Screen Recorder
Keyboard
Figure 2-2 SE-1200
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12-Channel Electrocardiograph User Manual
Introduction
2.2 Keyboard and Keys A B
F
C
G H
D E
I
J
L
K
M
N
Figure 2-3 SE-1200 Express/SE-1200 Keyboard
Name
Explanation
A
Function Key
Selecting menu functions on the screen
B
Delete
Deleting characters
C
Enter
Confirming operation Moving the cursor Pressing Tab can move the cursor forward, and pressing Shift + Tab can move the cursor backward.
D
Tab/Feed paper
E
Fn
F
Spacebar
G
Shift
Feed paper: when the main interface is displayed, if Paper Marker is set to Yes, you can press the Tab key to advance the recorder paper to the next black marker; if Paper Marker is set to No, you can press the Tab key to advance the paper for 2.5cm. Press the Tab key again to stop advancing the paper. Inputting special characters. Press Fn + a to type è. Adding a space between typed selecting/deselecting a checkbox
characters
Pressing Shift + Tab can move the cursor backward. - 11 -
or
12-Channel Electrocardiograph User Manual
Introduction
Press Shift and a number key to input the special character in the top right 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. Canceling operation H
Esc/Reset
I
Power On/Off
Note: A large polarization voltage may cause baseline drift. On the main interface, pressing the ESC key can decrease the polarization voltage and draw the baseline to zero quickly. Power-on/Power-off Press this key to select a working mode among the auto, manual, rhythm, R-R analysis, and off modes.
J
MODE
K
SLEEP/WAKE UP
L
COPY
M
START/STOP
Note: Only if a working mode is ticked on the Work Mode Setup interface, can the working mode be selected by pressing the MODE key when the main interface is displayed. Resting/wakening the electrocardiograph In the auto mode, pressing the Copy key can print the ECG report which was printed out last time. Start/Stop printing reports Moving the cursor (Up, Down, Left, Right)
N
Arrow Keys
In the manual mode, press the Up or Down arrow to switch the lead groups.
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12-Channel Electrocardiograph User Manual
Introduction
2.3 Front Panel
Figure 2-4 SE-1200 Express Front Panel
Figure 2-5 SE-1200 Front Panel
Symbol A B C
Name
Explanation
Mains supply indicator
When the device is powered by the mains supply, this indicator is lit.
Battery indicator
When the device is powered by the built-in rechargeable lithium battery, this indicator is lit.
Battery recharging indicator
When the battery is being recharged, this indicator is lit.
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12-Channel Electrocardiograph User Manual
Introduction
2.4 Rear Panel
Figure 2-6 SE-1200/SE-1200 Express Rear Panel
Name A
Explanation AC SOURCE: alternating current supply socket
Mains Supply Socket
B Potential Equalization Conductor
Potential equalization conductor provides a connection between the unit and the potential equalization bus bar of the electrical installation.
C
Handle
Part for people to hold
D
Heat Emission Hole
Path for internal heat emission
2.5 Right Panel C
A
D
B
E
G
F
Figure 2-7 SE-1200 Express/SE-1200 Right Panel
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12-Channel Electrocardiograph User Manual
Introduction
Name
Explanation
A
Patient Cable Socket
Connecting to the patient cable
B
Serial Port 1
Connecting to a PC
C
USB Socket 1 (Optional)
Standard USB socket, connecting to a PC
USB Socket 2 (Optional)
Standard USB socket, connecting to a U disk, a bar code reader or a USB printer recommended by the manufacturer
E
External Input / Output Socket
Connecting to the external signal device
F
Serial Port 2
Reserved
G
Net port
Standard net port, connecting to a PC
D
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 / V2
6
SH
11
F / LL
2
C3 / V3
7
NC
12
C1 / V1
3
C4 / V4
8
NC
13
or NC C1 / V1
4
C5 / V5
9
R / RA
14
RF (N) /RL or NC
5
C6 / V6
10
L / LA
15
RF (N) / RL
Note: The left side of “/” is European standard, and the right side is American standard. 2) Serial Port 1 - 15 -
12-Channel Electrocardiograph User Manual
Introduction
WARNING The isolated intensity of serial port 1 is 1500V AC and the maximum voltage applied should not exceed +15V DC.
Definitions of corresponding pins: Pin
Signal
Pin
Signal
Pin
Signal
1
NC
4
NC
7
NC
2
RxD (input)
5
GND
8
NC
3
TxD (output)
6
NC
9
NC
3) Serial Port 2 6 8
2
7
1
5
3 4
Definitions of corresponding pins: Pin
Signal
Pin
Signal
1
TxD (output)
5
NC
2
RxD (input)
6
NC
3
NC
7
GND
4
NC
8
GND
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12-Channel Electrocardiograph User Manual
Introduction
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)
5) USB Socket 1/USB Socket 2 (Optional)
CAUTION Only the USB equipment recommended by the manufacturer can be connected to the USB interface. 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
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12-Channel Electrocardiograph User Manual
Introduction
configuration shall comply with the valid version of the standard IEC/EN 60601-1-1. Therefore anybody, who connects additional equipment to the signal input or output connector to configure a medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or your local distributor. 2
The summation of leakage current should never exceed leakage current limits while several other units are used at the same time.
2.6 Bottom Panel D C
D
E B
A
Figure 2-8 SE-1200 Express/SE-1200 Bottom Panel
Name
Explanation
A
Speaker Hole
Path for sound from speaker
B
Battery Compartment
Compartment for lithium battery
C
Fuse
The specification is: T1AL250VP Ø5×20
D
Heat Emission Hole
Path for internal heat emission
E
Label
Position for product information label
1) Battery Compartment The rated voltage and the rated capacity of the rechargeable lithium battery pack are as - 18 -
12-Channel Electrocardiograph User Manual
Introduction
follows: SE-1200 Express: Rated Voltage: 14.8V; Rated Capacity: 4400mAh SE-1200: 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: T1AL250VP Ø5×20. WARNING Ruptured fuses must only be replaced with those of the same type and rating as the original.
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12-Channel Electrocardiograph User Manual
Introduction
2.7 Function Features ♦
Supporting multi-language
♦
Full alphanumeric keyboard (For SE-1200 Express, touch screen is available)
♦
Built-in rechargeable lithium battery with large capacity
♦
ECG signals of 12 leads are gathered and amplified simultaneously, 12-channel waves are displayed and recorded simultaneously
♦
High resolution thermal recorder, recording frequency response ≤150Hz
♦
Supporting external USB printer
♦
Flexible printing formats
♦
The auto, manual, rhythm, R-R analysis and off modes can be chosen freely
♦
Automatic baseline adjustment for optimal printing
♦
Convenient operation of system setup and file management
♦
Multiple file formats: DAT/SCP/FDA-XML/PDF
♦
Measurement function and interpretation function
♦
Hint information of lead off, lack of paper, low battery capacity etc.
♦
Supporting bar code reader
♦
ECG data can be transmitted to the PC software through the serial cable, net cable, or wireless AP (optional).
♦
Real-time transmission to PC ECG
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12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
Chapter 3 About the Electrocardiograph Application The following sections provide an overview of the main operations and functions. You can operate the electrocardiograph by using the keyboard. For SE-1200 Express, you can also carry out the operations by using the touch screen. CAUTION Do not touch the LCD screen with sharp things such as pencils or pens; otherwise, it will be damaged.
3.1 Selecting Menu Functions
To select Patient, press the function key F1 below Patient. To select Setup, press the function key F6 below Setup.
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12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
3.2 Entering Data
1. When the main interface is displayed, press the function key F1 below Patient to open the Patient Information window. 2. Press Tab or Shift + Tab to move the cursor to the Name textbox. 3. Press
on the keyboard to erase the typed information.
4. Press the letter or number keys on the keyboard to input patient name. Press Fn and a letter key to input the special character in the top right corner of the key. Press Shift
and a number
key to input the special character in the top right corner of the key. For example, press Fn + a to input è, and press Shift + 3 to input #. If Caps Lock is set to Off, pressing Shift letter key can input a capital letter. If Caps Lock is set to On, pressing Shift
and a and a letter
key can input a lowercase letter. 5. Press and then press
to confirm, or press Tab or Shift + Tab to move the cursor to the OK button, to confirm.
6. Press ESC to cancel the operation, or press Tab or Shift + Tab to move the cursor to the Cancel button, and then press
to cancel the operation.
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12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
3.3 Selecting an Item When the main interface is displayed, press the function key F6 below Setup to open the System Setup window. The cursor is on Work Mode. Press
to open the Work Mode Setup
interface.
1. Press Tab or Shift + Tab to move the cursor to R-R, press Spacebar to select it, and then a check mark √ appears in the box before R-R. 2. Press Tab or Shift + Tab to move the cursor to the Rhythm Style list box. Press the Up or Down arrow to highlight Single Lead or Three Leads. 3. Press and then press
to confirm, or press Tab or Shift + Tab to move the cursor to the OK button, to confirm.
4. Press ESC to cancel the operation, or press Tab or Shift + Tab to move the cursor to the Cancel button, and then press
to cancel the operation. - 23 -
12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
3.4 About the Main Interface After you turn on the device, the main interface pops up.
Figure 3-1 SE-1200 Express Main Interface B
D
F
E
C
G
H
I J
A
R
K Q
P
O
N
M
L
Figure 3-2 SE-1200 Main Interface - 24 -
12-Channel Electrocardiograph User Manual
A
About the Electrocardiograph Application
Name
Explanation
Name
Patient Name: within 60 ASCII characters or the equivalent number of other characters that can be supported by equivalent memory used by 60 ASCII characters When ID Mode is set to Manual, the patient ID is within 30 ASCII characters.
B
ID
When ID Mode is set to Auto, the patient ID is 0~1999, 999, 999. When ID Mode is set to Time, the patient ID is within 10 characters. Patient Age
C
Age
D
Gender
The patient age value and the age unit can be set in the Patient Information window. Patient Gender (Male/Female/Empty)
Hint Information 1
Including DEMO, Module Error, Overload, Lead Name (When the leads are off, the lead names will be shown in black on a yellow background in SE-1200 Express, while in SE-1200, they will be shown in black on a white background.)
F
Hint Information 2
Including No Paper, Paper Error, Battery Weak, Sampling, Analyzing, Recording, Testing, Learning, Transmitting, Transmit Fail, Detecting, Memory Full, U Disk, USB Printer, Lead Off, USB Scanner
G
Work Mode
Manual, Auto, Rhythm, R-R Analysis or Off
H
Heart Rate
Actual Heart Rate
I
Current Time
J
Battery Symbol
K
File
Press the function key F7 below File to open the File Manager interface. For details, please refer to Chapter 10, “Managing Files”.
L
Setup
Press the function key F6 below Setup to display the System Setup interface. For details, please refer to Chapter 11, “System Setup”.
E
Current examination time. Refer to Section 11.8.1, “Setting Date and Time”. Identify the current capacity of the rechargeable battery
EMG Filter: 25Hz, 35Hz or 45Hz M
Filter
Lowpass Filter: 75Hz, 100Hz or 150Hz Note: This setup can’t be saved if it is modified on the main interface. - 25 -
12-Channel Electrocardiograph User Manual
N
O
Gain
Speed
About the Electrocardiograph Application
Gain: 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 10/5 mm/mV or AGC Note: This setup can’t be saved if it is modified on the main interface. In the manual mode, you can set Speed to 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s or 50mm/s. In the auto and rhythm modes, only 25mm/s and 50mm/s are available. In the R-R analysis mode, only 25mm/s is available. Note: This setup can’t be saved if it is modified on the main interface.
Freeze
Freezing ECG waves. For details, please refer to Chapter 7, “Freezing ECG Waves”.
Q
Patient
Press the function key F1 below Patient to open the Patient Information window. For details, please refer to Chapter 6, “Entering Patient Information”.
R
ECG waveform
P
Display ECG waveform
3.5 About the System Setup Interface When the main interface is displayed, press the function key F6 below Setup to display the System Setup interface. Note: If you set the system password on the System Maintenance interface, you need enter the password before opening the System Setup interface. For details, refer to Section 11.10.7, “Setting System Password”.
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12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
On the System Setup interface, press Tab or Shift + Tab, or the Up, Down, Left or Right arrow to move the cursor. When the cursor is on an item, press
to open the setup interface of
the item. Take the Work Mode Setup interface for example:
Check Box Textbox
Dropdown List Box
1. On the Work Mode Setup interface, press Tab or Shift + Tab to move the cursor among different check boxes. Press Spacebar to select a check box, and a check mark √ appears in the box. - 27 -
12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
2. On the Work Mode Setup interface, press Tab or Shift + Tab to move the cursor to a list box or dropdown. Press the Up or Down arrow to highlight an option. 3. On the Work Mode Setup interface, press Tab or Shift + Tab to move the cursor to a textbox. Fill in the selected textbox. 4. Press and then press
to confirm, or press Tab or Shift + Tab to move the cursor to the OK button, to confirm.
5. Press ESC to cancel the operation, or press Tab or Shift + Tab to move the cursor to the Cancel button, and then press
to cancel the operation.
3.6 About the File Manager Interface When the main interface is displayed, press the function key F7 below File to open the File Manager interface1. Press the Up or Down arrow to highlight a file on the File Manager interface1, and then press the function key F4 below Select to select the file and display the File Manager interface2. Then press the function key F7 below Return to return to the File Manager interface1. Press the function key F7 below Return on the File Manager interface1 to return to the main interface.
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12-Channel Electrocardiograph User Manual
A
B
C
About the Electrocardiograph Application
D
E
F
G
Figure 3-3 File Manager Interface1
H
I
J
K
L
M
Figure 3-4 File Manager Interface2
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N
12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
Name
Explanation
A
Trans All
Press the function key F1 below Trans All to transmit all the files to the PC.
B
Export All
Press the function key F2 below Export All to export all the files from the electrocardiograph to the U disk.
C
Del All
Press the function key F3 below Del All to delete all the files from the electrocardiograph.
D
Select
Press the Up or Down arrow to highlight a file on the File Manager interface1, and then press the function key F4 below Select to select the file and display the File Manager interface2.
E
Search
Press the function key F5 below Search to open the SearchInfo Setup window.
F
Import
Press the function key F6 below Import to import files from the U disk to the electrocardiograph.
G
Return
Press the function key F7 below Return to return to the main interface.
H
Edit
Press the function key F1 below Edit to open the Patient Information window. Then you can edit the patient information.
I
Record
J
Trans
Press the function key F3 below Trans to transmit the selected file to the PC.
K
Export
Press the function key F4 below Export to export the selected file from the electrocardiograph to the U disk.
L
Delete
Press the function key F5 below Delete to delete the selected file from the electrocardiograph.
M
Preview
Press the function key F6 below Preview to open the file preview interface.
N
Return
Press the function key F7 below Return to return to the File Manager interface1.
Press the function key F2 below Record to print the selected file.
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12-Channel Electrocardiograph User Manual
Operation Preparations
Chapter 4 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.
4.1 Power and Earthing WARNING If the integrity of the external protective conductor is in doubt, the equipment should be powered by the built-in rechargeable battery. Power Supply The electrocardiograph can be powered by either the mains supply or the built-in rechargeable lithium battery. ♦ Mains Supply The mains socket is on the rear panel of the unit. If the mains supply is used, connect the power cord to the socket first, and then connect the power cord to the hospital grade outlet. Operating voltage:
100V-240V~
Operating frequency:
50Hz/60Hz
Input power:
70VA
Make sure that the mains supply meets the above requirements before power-on, and then press
on the keyboard to power on the unit. The mains supply indicator ( ) is lit.
If the built-in rechargeable battery is weak when the mains supply is used, it will be recharged automatically at the same time. Both the mains supply indicator ( ) and the battery recharging indicator (
) will be lit.
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12-Channel Electrocardiograph User Manual
Operation Preparations
♦ Built-in Rechargeable Battery When the built-in rechargeable lithium battery is used, turn on the unit by pressing on the keyboard. Then the battery indicator (
) will be lit and the battery symbol will be
displayed on the LCD screen. Because of the consumption during the storage and transport course, the battery capacity may not be full. If the symbol
and the hint information
Battery Weak are displayed, which means the battery capacity is low, please recharge the battery first. CAUTION If the electrocardiograph is turned off automatically because of low battery capacity, the settings may not be saved. When the battery is fully charged, SE-1200 can work normally about 4 hours, and print about 300 ECG reports of 3×4+1R in the auto mode; SE-1200 Express can work normally about 5 hours, and print about 350 ECG reports of 3×4+1R in the auto mode. Please refer to the maintenance section for how to recharge the battery. When the battery is being recharged, the electrocardiograph can be powered by the mains supply. WARNING Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical installation when necessary.
4.2 Loading/Replacing Recorder Paper Two kinds of recorder paper can be used. One is the folded thermal paper, and the other is the rolled thermal paper. Notes: 1. When the folded thermal paper is used, the paper roller is unnecessary and must be taken out. 2. When using the paper of 216mm in width, the two movable parts should be removed. 3. The exit edge can help you tear the recorder paper.
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12-Channel Electrocardiograph User Manual
Operation Preparations
CAUTION Make sure that the recorder paper, especially the rolled paper, is installed in the center of the recorder, and the paper edge is parallel with the casing edge in the direction of advancing paper, in order to avoid paper deviation or damage to the paper edge. When the recorder paper runs out or is not loaded, the hint message No Paper will appear on the screen. Then you should load or replace the recorder paper immediately.
Movable
Groove
Part 1 Paper Tray
Exit Edge (Edge for tearing paper)
Casing Button
Exit
Paper Roller
Casing
Loading/Replacing Process of Folded Paper: 1) Press the casing button downwards and remove the casing to open the recorder.
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Movable Part 2
12-Channel Electrocardiograph User Manual
Operation Preparations
2) Remove the remainder paper from the paper tray if necessary. 3) Take off the wrapper of the new folded paper, and then put it in the paper tray.
4) Pull the paper out with the grid side facing the thermal print head, and replace the casing on the recorder.
5) Press down the recorder casing firmly. 6) To select Paper Marker. Press
on the keyboard to turn on the unit. After the main interface is displayed,
press the function key F6 below Setup to display the System Setup interface. Press Tab or Shift + Tab, or the Up, Down, Left or Right arrow to move the cursor. When the cursor is on Record Info on the System Setup interface, press
to open the
Record Info Setup interface. Press Tab or Shift + Tab to move the cursor to the Paper Marker list box, and then press the Up or Down arrow to highlight No or Yes. Press to confirm, and then the System Setup interface appears. Press ESC to return
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12-Channel Electrocardiograph User Manual
Operation Preparations
to the main interface. 7) Advance the recorder paper. When the main interface is displayed, if Paper Marker is set to Yes, you can press to advance the recorder paper to the next black marker; if Paper Marker is set to No, you can press again to stop advancing the paper.
to advance the paper for 2.5cm. Press
Loading/Replacing Process of Rolled Paper: 1) Press the casing button downwards and remove the casing to open the recorder.
2) Take out the paper roller, and remove remainder paper from the roller if necessary. 3) Take off the wrapper of the new thermal paper roll, and then put the paper roll through the roller. 4) Place the paper and the roller gently in the recorder with the roller pin clicking into the groove. Groove
5) Pull the paper out with the grid side facing the thermal print head, and replace the casing on the recorder. - 35 -
12-Channel Electrocardiograph User Manual
Operation Preparations
6) Press down the recorder casing firmly. 7) To select Paper Marker. Press
on the keyboard to turn on the unit. After the main interface is displayed,
press the function key F6 below Setup to display the System Setup interface. Press Tab or Shift + Tab, or the Up, Down, Left or Right arrow to move the cursor. When the cursor is on Record Info on the System Setup interface, press
to open the
Record Info Setup interface. Press Tab or Shift + Tab to move the cursor to the Paper Marker list box, and then press the Up or Down arrow to highlight No. Press to confirm, and then the System Setup interface appears. Press ESC to return to the main interface. 8) Advance the recorder paper. When the main interface is displayed, you can press for 2.5cm. Press
to advance the paper
again to stop advancing the paper.
4.3 Preparing the Patient 4.3.1 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 - 36 -
12-Channel Electrocardiograph User Manual
Operation Preparations
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.
4.3.2 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.
4.4 Connecting the Patient Electrocardiograph and Electrodes
Cable
to
the
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.
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12-Channel Electrocardiograph User Manual
Operation Preparations
Main Cable
Lead Wires
Screw Electrode Connector Connecting
to
the
Electrocardiograph
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. 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.
4.5 Attaching Electrodes to the Patient 4.5.1 Lead Placement 4.5.1.1 Standard 12-Lead Placement 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 4-1. Moreover the equivalent codes according to European requirements are given in Table 4-1 too. Table 4-1 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
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12-Channel Electrocardiograph User Manual
Right leg/Upper leg as
Operation Preparations
N or RF
Black
RL
Green
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
close to torso as possible
Left leg/Upper leg as close to torso as possible
As the following figure shows, the positions of chest electrodes on the body surface are C1: Fourth intercostal space at the right border of the sternum C2: Fourth intercostal space at the left border of the sternum C3: Fifth rib between C2 and C4 C4: Fifth intercostal space on the left midclavicular line C5: Left anterior axillary line at the horizontal level of C4 C6: Left midaxillary line at the horizontal level of C4
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12-Channel Electrocardiograph User Manual
Operation Preparations
4.5.1.2 NEHB Placement The electrodes’ positions on the body surface are shown in the following table and figure.
American European
Electrode Placement
Label
Label
A1
Nst
Attachment point of the second rib to the right sternal edge
A2
Nax
Fifth intercostal space on the left posterior axillary line
V4
Nap
Left mid-clavicular line in the fifth intercostal space
RA
R
Right arm
LA
L
Left arm
RL
N or RF
Right leg
LL
F
Left leg
4.5.2 Electrode Placement Two kinds of electrode can be used, one is the reusable electrode, and the other is the disposable electrode.
4.5.2.1 Reusable Electrodes Reusable electrodes include limb electrodes and chest electrodes, as the following figures show.
Suction Bulb
Connecting to a Lead Wire
Metal Cup Chest Electrode - 40 -
12-Channel Electrocardiograph User Manual
Operation Preparations
Connecting to a Lead Wire
Reed Clamp Limb Electrode
Chest Electrode Connection: 1)
Ensure that the electrodes are clean;
2)
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;
3)
Clean the electrode area on the chest surface with 75% alcohol;
4)
Daub the round area of 25mm in diameter on each electrode site with gel evenly;
5)
Place a small amount of gel on the brim of the chest electrode’s metal cup;
6)
Place the electrode on the chest electrode site and squeeze the suction bulb. Unclench it and the electrode is adsorbed on the chest;
7)
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 small children or patients with delicate skin, squeeze the suction ball lightly. Limb Electrode Connection: 1)
Ensure that the electrodes are clean;
2)
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;
3)
Clean the electrode area which is a short distance above the ankle or the wrist with 75% alcohol;
4)
Daub the electrode area on the limb with gel evenly;
5)
Place a small amount of gel on the metal part of the limb electrode clamp;
6)
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;
7)
Attach all limb electrodes in the same way.
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12-Channel Electrocardiograph User Manual
Operation Preparations
4.5.2.2 Disposable Electrodes Disposable Electrode:
Alligator Clip:
Disposable electrodes must be used together with alligator clips. Disposable Electrode Connection 1) Align all lead wires of the patient cable to avoid twisting, and connect the alligator clips to the lead wires. 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. 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. 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. CAUTION The disposable electrodes can only be used for one time. - 42 -
12-Channel Electrocardiograph User Manual
Operation Preparations
4.6 Inspection Before Power-On In order to avoid safety hazards and get good ECG records, the following inspection procedure is recommended before power-on and 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. Turn off these devices when necessary.
♦
Keep the examination room warm to avoid muscle tremor voltages in ECG signals caused by cold.
2) Power Supply: ♦
If the mains supply is used, please check whether the power cord is connected to the unit well. The grounded three-slot outlet should be used.
♦
When the battery capacity is low, recharge the battery before use.
3) Patient Cable: ♦
Make sure that the patient cable is connected to the unit firmly, and keep it far away from the power cord.
4) Electrodes: ♦
Make sure that all electrodes are connected to lead wires of the patient cable correctly.
♦
Ensure that the chest electrodes do not contact.
5) Recorder Paper: ♦
Ensure that there is enough recorder paper loaded correctly.
6) Patient: ♦
The patient should not come into contact with conducting objects such as earth, metal parts etc.
♦
Ensure that the patient is warm and relaxed, and breathes calmly. WARNING
The electrocardiograph is intended to be used by qualified physicians or personnel - 43 -