User Manual
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EDAN INSTRUMENTS, INC.
SE-3 3Manual Ver: V1.7 Release Date: Aug. 2008 Part Number: MS1R-20055-V1.7
Copyright © Copyright EDAN INSTRUMENTS, INC. 2008. All rights reserved.
Statement Edan Instruments, Inc. (hereinafter called EDAN) makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. EDAN assumes no responsibility for any error that may appear in this document, or for incidental or consequential damage in connection with the furnishing, performance or use of this material. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of EDAN. All information contained in this publication is believed to be correct. EDAN shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this material. This publication may refer to information and protected by copyrights or patents and does not convey any license under the patent rights of this company, nor the rights of others. This company does not assume any liability arising out of any infringements of patents or other rights of third parties. The information contained in this document is subject to change without notice.
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. NOTE: This device is not intended for home use. WARNING
: This device is not intended for treatment.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable. -I-
Using This Label Guide 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 1 SAFETY GUIDANCE .............................................................................................................. 1 1.1 SAFETY INFORMATION .......................................................................................................... 1 1.2 WARNINGS AND CAUTIONS................................................................................................... 1 1.2.1 Safety Warnings.......................................................................................................... 2 1.2.2 Battery Care Warnings............................................................................................... 3 1.2.3 General Cautions........................................................................................................ 4 1.2.4 Cleaning & Disinfection Cautions............................................................................. 5 2 INTRODUCTION...................................................................................................................... 6 2.1 FUNCTION FEATURES ........................................................................................................... 6 2.2 LIST OF SYMBOLS ................................................................................................................. 7 3 GENERAL INFORMATION .................................................................................................. 10 3.1 TOP PANEL.......................................................................................................................... 10 3.1.1 LCD Screen ............................................................................................................... 10 3.1.1.1 LCD Screen (320×240 dot single color)................................................................ 11 3.1.1.2 LCD Screen (192×64 dot single color).................................................................. 12 3.1.2 Control Panel and Keys........................................................................................... 12 3.2 PATIENT CABLE SOCKET AND SIGNAL INTERFACE ............................................................. 15 3.3 MAINS CONNECTION AND SWITCH ..................................................................................... 18 3.4 BOTTOM PANEL .................................................................................................................. 18 4 OPERATION PREPARATIONS........................................................................................... 20 4.1 POWER AND EARTHING ...................................................................................................... 20 4.2 LOADING/REPLACING RECORD PAPER .............................................................................. 21 4.3 PATIENT CABLE CONNECTION ............................................................................................ 22 4.4 ELECTRODES CONNECTIONS ............................................................................................. 23 4.5 INSPECTION BEFORE POWER ON ....................................................................................... 25 5 OPERATION INSTRUCTIONS ............................................................................................ 27 5.1 SWITCHING ON ................................................................................................................... 27 5.2 AUTO MODE ...................................................................................................................... 27 5.3 MANUAL MODE ................................................................................................................ 28 5.4 RHYTHM MODE ................................................................................................................ 28 5.5 USBPRT MODE ................................................................................................................. 29 5.6 ECG RECALL OPERATION.................................................................................................. 29 5.6.1 ECG Recall ................................................................................................................ 29 5.6.2 ECG Copy.................................................................................................................. 32 5.7 USING THE MENU SYSTEM ................................................................................................. 33 -III-
5.7.1 Entering and Exiting the Menu ............................................................................... 33 5.7.2 Moving in the Sub-menus ....................................................................................... 33 5.7.3 Parameter Modification............................................................................................ 33 5.7.4 Switching between the Setup Windows (only for 320×240 dot single color LCD Screen)................................................................................................................................... 34 5.8 SETTINGS (320×240 DOT SINGLE COLOR LCD SCREEN) ................................................. 34 5.8.1 LOGIN Settings......................................................................................................... 34 5.8.2 RECORD Settings .................................................................................................... 35 5.8.2.1 Lead Settings ......................................................................................................... 35 5.8.2.2 Sample Mode Settings ......................................................................................... 36 5.8.2.3 Recording Settings................................................................................................ 36 5.8.2.4 Measurement and Interpretation......................................................................... 37 5.8.2.5 Parameter Options ................................................................................................ 38 5.8.3 GENERAL Settings .................................................................................................. 39 5.8.3.1 Filter Settings ......................................................................................................... 39 5.8.3.2 External Input/Output Settings ............................................................................ 40 5.8.3.3 Key Beep & QRS Beep Settings......................................................................... 40 5.8.3.4 IP Settings .............................................................................................................. 40 5.8.3.5 Save Option Settings ............................................................................................ 40 5.8.3.6 Transfer Settings ................................................................................................... 41 5.8.3.7 Parameter Options ................................................................................................ 42 5.8.4 SYSTEM Settings..................................................................................................... 42 5.8.4.1 Display Mode Settings.......................................................................................... 43 5.8.4.2 Parameter Options ................................................................................................ 45 5.8.5 Settings (192×64 dot single color) ......................................................................... 45 5.9 AUTO MODE RECORD ........................................................................................................ 47 5.10 RHYTHM MODE RECORD................................................................................................ 49 5.11 USBPRT MODE RECORD ................................................................................................. 51 5.12 SWITCH OFF ..................................................................................................................... 52 6 HINT INFORMATION ............................................................................................................ 53 7 TECHNICAL SPECIFICATIONS ......................................................................................... 54 8 CLEAN, CARE AND MAINTENANCE ............................................................................... 57 8.1 CLEAN ................................................................................................................................. 57 8.1.1 Clean the Main Unit and Patient Cable................................................................. 57 8.1.2 Clean the Electrodes................................................................................................ 57 8.1.3 Clean the Print Head................................................................................................ 57 8.2 DISINFECTION ..................................................................................................................... 58 8.3 CARE AND MAINTENANCE .................................................................................................. 58 8.3.1 Recharge and Replacement of Battery................................................................. 58 -IV-
8.3.2 Record Paper ............................................................................................................ 59 8.3.3 Maintenance of Main Unit, Patient Cable & Electrodes ..................................... 59 9 ACCESSORIES...................................................................................................................... 62 10 WARRANTY & SERVICE POLICY................................................................................... 63 11 EMC INFORMATION - GUIDANCE AND MANUFACTURE’S DECLARATION ...... 65 11.1 ELECTROMAGNETIC EMISSIONS - FOR ALL EQUIPMENT AND SYSTEMS................... 65 11.2 ELECTROMAGNETIC IMMUNITY - FOR ALL EQUIPMENT AND SYSTEMS ..................... 65 11.3 ELECTROMAGNETIC IMMUNITY - FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING .............................................................................................................. 66 11.4 RECOMMENDED SEPARATION DISTANCES ....................................................................... 67
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SE-3 3-Channel Electrocardiograph User Manual
1 Safety Guidance 1.1 Safety Information The design of SE-3 3-channel electrocardiograph complies with international standard IEC/EN 60601-1 Medical Electrical Equipment: General Requirements for Safety and IEC/EN 60601-2-25 Particular Requirements for the Safety of Electrocardiographs etc. The classification of this equipment is Class І, type CF, which means a higher degree of protection against electric shock and the patient connection is fully isolated and defibrillation protected. This equipment is not explosion-proof. Do not use it in the presence of flammable anesthetics. This equipment is designed for continuous operation and is ‘ordinary’ (i.e. not drip or splash-proof). Classification: 1) Anti-electric-shock type:
Class І with internal power supply
2) Anti-electric-shock degree:
CF
3) Degree of protection against harmful ingress of water:
Ordinary equipment (Sealed equipment without liquid proof)
4) Disinfection/sterilization method:
Refer to the user manual for details
5) Degree of safety of application in the presence of flammable gas:
Equipment not suitable for use in the presence of flammable gas
6) Working Mode:
Continuous operation
7) EMC:
Group І
1.2 Warnings and Cautions In order to use the electrocardiograph safely and effectively, avoiding possible dangers caused by improper operations, please read through the user manual and be sure to be familiar with all functions of the equipment and proper operation procedures before use. Please pay more attention to the following warning and caution information.
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SE-3 3-Channel Electrocardiograph User Manual
1.2.1 Safety Warnings WARNING
:
1. The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained. And 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 EDAN can open the shell. 3. Only qualified installation or service engineers can shift the mains shift switch (100V~115V/220V~240V) according to local mains supply. 4. The results given by the equipment should be examined with respect to the overall clinical condition of the patient. And it can not substitute for regular checking. WARNING
:
5. EXPLOSION HAZARD-Do not use the electrocardiograph in the presence of flammable anesthetic mixture 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 external protective conductor in installation or arrangement is in doubt, the equipment should be operated from the 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 direct cardiac application. WARNING
:
10. Only patient cable and other accessories supplied by EDAN can be used. Or else, the performance and electric shock protection can not be guaranteed. 11. Be sure that all electrodes have been connected to the patient correctly before operation. 12. Ensure that the conductive parts of electrodes and associated connectors, including neutral electrode, do not come in contact with earth or any other -2-
SE-3 3-Channel Electrocardiograph User Manual
conducting objects. 13. Electrodes with defibrillator protection should be used while defibrillating. 14. There is no danger for patients with pacemaker. However, if a pacemaker is used, the results given by the equipment may be invalid, or lose the clinical significance. 15. Do not touch the patient, bed, table and the equipment while using defibrillator or pacemaker simultaneously. 16. In order to avoid burning, please keep the electrode far away from the radio knife while using electrosurgical equipment simultaneously. 17. Always use electrode gel with reusable electrodes during defibrillation as ECG recovery will be greater than 10 seconds. EDAN recommends the use of disposable electrodes at all times. WARNING
:
18. 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 connector 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. 19. The summation of leakage current should never exceed leakage current limits while several other units are used at the same time. 20. The potential equalization conductor can be connected to that of other equipment when necessary, to make sure that all these equipment are connected with the potential equalization bus bar of the electrical installation.
1.2.2 Battery Care Warnings WARNING
:
21. Improper operation may cause the battery to be hot, ignited or exploded, and it may lead to the declination of battery’s capacity. It is necessary to read the user
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SE-3 3-Channel Electrocardiograph User Manual
manual carefully and pay more attention to warning messages. 22. Only qualified service engineer authorized by EDAN can open the battery compartment and replace the battery. And the battery of same model and specification provided by manufacturer should be used. 23. Danger of explosion -- Do not reverse the anode and cathode when connecting the battery. 24. Do not heat or splash the battery or throw it into fire or water. 25. When leakage or foul smell 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. 26. When the battery’s useful life is over, contact the manufacturer or local distributor for disposal or dispose the battery according to local regulations.
1.2.3 General Cautions CAUTION
:
1. Avoid liquid splash and excessive temperature. The temperature must be kept between 5℃ and 40℃ while working. And it should be kept between -20 ℃ and 55℃ during transportation & storage. 2.
Do not use the equipment in dusty environment with bad ventilation or in the presence of corrosive.
3.
Be sure that there is no intense electromagnetic interference source around the equipment, such as radio transmitter or mobile phone etc. Attention: large medical electrical equipment such as electrosurgical equipment, radiological equipment and magnetic resonance imaging equipment etc. are likely to bring electromagnetic interference.
CAUTION 4.
:
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 performance.
5.
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 -4-
SE-3 3-Channel Electrocardiograph User Manual
perform these tests. a) Inspect the equipment and accessories for mechanical and functional damage. b) Inspect the safety relevant labels for legibility. c) Inspect the fuse to verify compliance with rated current and breaking characteristics. d) Verify the device functions properly as described in the instructions for use. e) Test the protection earth resistance according to IEC/EN 60601-1: Limit 0.2 ohm. f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 uA, SFC 1000uA. g) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10 uA (CF). h) Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC/EN 60601-1: Limit: 50uA (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. 6. Ruptured fuse must only be replaced with the same type and rating as the original. 7. When the effective lifetime of the equipment and accessories is over, collect and classify them, and dispose them according to local regulations. 8. Federal (US) law restricts this device to sale by or on the order of a physician.
1.2.4 Cleaning & Disinfection Cautions CAUTION
:
9. Turn off the power before cleaning and disinfection. If mains supply used, the power cord should be drugged out of the outlet also. And prevent the detergent from seeping into the equipment. 10. Do not immerse the unit or patient cable into liquid under any circumstances. 11. Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes. 12. Any remainder of detergent should be removed from the unit and patient cable after cleaning. 13. Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
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SE-3 3-Channel Electrocardiograph User Manual
2 Introduction SE-3 is 3-channel electrocardiographs with 12 leads gathered simultaneously, visual display of operation menu, ECG parameters as well as electrocardiogram. 3-channel ECG can be viewed on the LCD (liquid crystal display) screen of SE-3 simultaneously. And it can be recorded by high-quality thermal recorder. Auto, manual, rhythm, USB print and off mode can be chosen conveniently. Either mains supply or built-in rechargeable Lithium battery can be used as power. With a high resolution thermal printer, 32-bit processor and huge capacity memorizer, SE-3 has advanced performance and high reliability. And the compact size makes it suitable for clinic, hospital and ambulance use. Configurations: Main unit and accessories (power cord, earth wire, patient cable, electrodes and thermal record paper) Intended use: The intended use of 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 ECG with measurements and interpretive statements is offered to clinician on an advisory basis only WARNING only.
: This equipment is intended for use in adult and pediatric patients
WARNING
: This equipment is not designed for direct cardiac application.
WARNING
: The results given by the equipment should be examined with respect to the overall clinical condition of the patient. And it can not substitute for regular checking.
2.1 Function Features ♦
Low weight and compact size
♦
Touch key for easy operation
♦
High resolution thermal recorder, recording frequency response ≤150Hz
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SE-3 3-Channel Electrocardiograph User Manual
♦
12-lead gathered and amplified simultaneously, 3-channel built-in recorder
♦
Auto mode, manual mode, rhythm mode, USB print mode and off mode optional
♦
Measurement function and interpretation function optional
♦
LOGIN/PRINT/GENERAL/SYSTEM menu for parameters setting (Only for the device with 320×240 dot single color LCD Screen)
♦
Built-in rechargeable Li battery with high capacity
♦
Hint information for lead off, lack of paper and low battery capacity etc.
♦
Automatic adjustment of baseline for optimal recording
♦
Standard input/output interface and RS232 communication interface for linking to special network and setting up ECG database
2.2 List of Symbols
External output
External input
Equipment or part of CF type with defibrillator proof
Attention – general warning (see accompanying document)
Potential equalization
Mains supply
On (mains supply)
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SE-3 3-Channel Electrocardiograph User Manual
Off (mains supply)
Battery indicator
Battery recharging indicator
Sensitivity switch key
Recall key
1mV calibration key& Copy key
Mode/RST switch key
Lead switch key
Print/Stop key
ON/OFF key
Menu key
Up Arrow/Down Arrow key
Left Arrow/ Right Arrow key
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SE-3 3-Channel Electrocardiograph User Manual
Recycle
Part Number
Serial Number
Date of Manufacture
Manufacturer
Authorized Representative in the European Community This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993, a directive of the European Economic Community. It indicates that the equipment should be sent to the special agencies according to local regulation for separate collection after its useful life. It indicates that the equipment is put on the market after 13 August 2005. Rx only
Federal (US) law restricts this device to sale by or on the order of a physician
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SE-3 3-Channel Electrocardiograph User Manual
3 General Information 3.1 Top Panel Smart ECG SE-3 LCD Screen Record Paper USB Interface
Recorder
External
Control Panel
Input/Output
Socket RS232 Socket Patient Cable Socket Figure 3-1 Main Unit (320×240 dot single color LCD Screen)
Product Information: 1) Trademark
2) Trade Name Smart ECG 3) Model SE-3 (3-channel electrocardiograph) 4) Classification Symbol Equipment of CF type with defibrillator proof
3.1.1 LCD Screen The LCD Screen has two specifications: 320×240 dot single color LCD Screen or 192×64 dot single color LCD Screen. -10-
SE-3 3-Channel Electrocardiograph User Manual
3.1.1.1 LCD Screen (320×240 dot single color) ID: 210605-1812
Female
Age 30
AUTO
11:01:43
60 R L F C1 C2C3 C4 C5 C6 10mm/mV 25mm/s AC ON EMG OFF
Main Interface (320×240 dot single color LCD screen)
Normally, the contents displayed on the LCD screen include: Top Row (describing from left to right): ♦
Patient ID(created automatically according to current date and time)
♦
Sex (Male/Female) and Age
♦
Record mode(AUTO, MANUAL, RHYTHM, USBPRT or OFF)
♦
Current time and battery capacity(only when the built-in battery is used)
Right Row (describing from top to bottom): ♦
Heart rate
♦
Electrodes and electrode status (Black background shows the status of Lead OFF)
♦
Sensitivity (×2.5mm/mV, ×5mm/mV, ×10mm/mV, ×20mm/mV, AGC while in
( Actual heart rate)
manual mode and auto sensitivity symbol while in auto mode) ♦
Record speed (5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s)
♦
AC FILTER (AC ON, AC OFF)
♦
EMG FILTER (EMG OFF, EMG25Hz, EMG35Hz, EMG45Hz)
♦
Hint information (Paper?, Printing, Sampling, Bat Weak etc.)
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SE-3 3-Channel Electrocardiograph User Manual
3.1.1.2 LCD Screen (192×64 dot single color) AUTO Paper? I II III 10mm/mV
M ♥60
35Y
Main Interface (192×64 dot single color LCD screen)
Normally, the contents displayed on the LCD screen include: (descript from left to right) First Row: ♦
Record mode(AUTO, MANUAL, RHYTHM, USBPRT or OFF)
♦
Hint information (Paper?, Printing, Sampling, Bat Weak etc.)
♦
Sex (Male/Female) and Age
Second Row: ♦
Current lead (І, П, Ш, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6)
♦
Sensitivity (×2.5mm/mV, ×5mm/mV, ×10mm/mV, ×20mm/mV, AGC while in manual mode and auto sensitivity symbol while in auto mode)
♦
Heart rate
♦
Battery capacity(Only when the built-in battery is used)
( Actual heart rate)
Third Row: ♦
ECG wave
3.1.2 Control Panel and Keys
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SE-3 3-Channel Electrocardiograph User Manual
1)
Indicator Lamp Mains supply indicator lamp: when mains supply is used, the lamp will be light. Battery indicator lamp: when the built-in rechargeable Lithium battery is used, the lamp will be light. Battery recharging indicator lamp: when the battery is recharged, this lamp will be light.
2) SENS (Sensitivity Switch Key)
The sensitivity switching order: ×10 mm/mV→×20 mm/mV → AGC→×2.5 mm/mV→ ×5 mm/mV. And AGC means auto gain control. 3) Recall Key
Press this key to review the patient files saved in the recall window. 4) 1mV/COPY Key
Under MANUAL mode, this key can be pressed to record a 1mV calibration pulse at any time while recording. Under AUTO mode, once the hint information “COPY” appears in the hint information field on the LCD screen, this key can be pressed to recall the electrocardiogram that recorded last time. 5) MODE/RST (Mode Switch Key)
This key can be pressed to select record mode between AUTO, MANUAL, RHYTHM, USBPRT and OFF. The switching order of lead groups is listed in Table 3-1. Recording under Manual mode, this key can be pressed to reset the waveform quickly. -13-
SE-3 3-Channel Electrocardiograph User Manual
WARNING
:
When using the device with defibrillator, after the defibrillator discharge, the MODE/RST key should be pressed to reset the waveform quickly. Table 3-1 Lead Group Switching order of Different Mode Mode
Switching Order (from left to right)
AUTO(Standard)
І/П/Ш
aVR/aVL/aVF
V1/V2/V3
V4/V5/V6
AUTO(Cabrera)
aVL/ I /-aVR
II /aVF/ III
V1/V2/V3
V4/V5/V6
In this mode, need to press Lead Switch Key to change the lead , the MANUAL
lead
switch
order
can
be
that
of
AUTO(Standard)
or
AUTO(Cabrera), which is determined by settings of lead sequence and record format in the MENU
6) LEAD (Lead Switch Key)
Under MANUAL mode, press the key to switch the lead group. For 192×64 dot single color LCD screen electrocardiograph, this key can be pressed to turn the pages in Recall window or Menu interface. 7) PRINT/STOP Key
Used to begin recording and stop recording. 8) ON/OFF Key
When the unit has been powered on, press this key to turn on it. Press again to turn off it. 9) MENU Key
Press this key to enter menu settings.
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SE-3 3-Channel Electrocardiograph User Manual
10) Up Arrow/Down Arrow
Press the Up Arrow to select the items of main interface on the LCD screen counterclockwise while press the Down Arrow to select the items of main interface on the LCD screen clockwise. (hereinafter called Up/Down) During MENU setting, the two keys can also be pressed to select the item of which the setting is to be changed. 11) Left Arrow/ Right Arrow
Press these keys to change the content of the selected item. During MENU setting, these keys can also be pressed to change the content of the selected item. (hereinafter called Left/Right)
3.2 Patient Cable Socket and Signal Interface There are sockets including the patient cable socket, RS232 socket, external input/output socket and USB interface at the right side of the main unit as Figure 3-1 shows. 1) Patient Cable Socket
: Applied part of type CF with defibrillator proof : Attention – see accompanying document
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SE-3 3-Channel Electrocardiograph User Manual
Definition of corresponding pins: Pin
Signal
Pin
Signal
Pin
Signal
1
C2 (input)
6
SH
11
F (input)
2
C3 (input)
7
NC
12
NC
3
C4 (input)
8
NC
13
C1(input)
4
C5 (input)
9
R (input)
14
NC
5
C6 (input)
10
L (input)
15
N or RF (input)
2) RS232 Socket WARNING
:
RS232 interface is 1500V AC isolated intensity and the maximum voltage applied should not exceed +15V DC.
Definition 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) External Input/Output Socket
Definition of corresponding pins: Pin
Signal
Pin
1
GND
4
GND
2
GND
5
ECG Signal (input)
3
GND
6
ECG Signal (output)
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Signal
SE-3 3-Channel Electrocardiograph User Manual
4) USB Interface
Definition of corresponding pins: Pin
Signal
Pin
1
VBUS
3
D+
2
D-
4
GND
WARNING
Signal
: Only the USB equipments recommended by EDAN can be connected to the USB interface.
WARNING ♦
:
Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN60950 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.
♦
The summation of leakage current should never exceed leakage current limits while several other units are used at the same time.
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SE-3 3-Channel Electrocardiograph User Manual
3.3 Mains Connection and Switch
Potential equalization terminal Mains Power Switch Mains Supply Socket
1) Potential Equalization Terminal Potential equalization conductor provides a connection between the unit and the potential equalization bus bar of the electrical installation. 2) Mains Supply Socket AC SOURCE: alternating current supply socket 3) Power Switch : Switch on
: Switch off
3.4 Bottom Panel Mains Supply Shift Switch
Battery Compartment
Fuse
Fuse Label
Label
1) Battery Compartment The battery label indicates the rated voltage and rated capacity of rechargeable Lithium battery pack. Rated voltage: 14.8V, Rated capacity: 2000mAh /2200mAh /2400mAh. Attention – general warning (see accompanying document)
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SE-3 3-Channel Electrocardiograph User Manual
WARNING
:
Improper operation may cause the battery to be hot, ignited or exploded, and it may lead to the decrease of battery’s capacity. Therefore, it is necessary to read the user manual carefully and pay more attention to warning messages. WARNING
:
When leakage or foul smell found, stop using the battery immediately. If the leakage liquid gets to your skin or cloth, cleanse it with clean water at once. If the leakage liquid gets into your eyes, do not wipe them. Irrigate them with clean water first and go to see a doctor immediately. WARNING
:
Only qualified service engineer authorized by EDAN can open the battery compartment and replace the battery. And the battery of same model and specification provided by manufacturer must be used. 2) Mains Supply Shift Switch
Mains supply with rated input voltage 230V (220V~240V) or 115V (100V~115V) can be chosen by the shift switch according to local mains supply specification. WARNING
: Only qualified installation or service engineers can shift the mains shift switch according to local mains supply.
3) Fuse There are two same fuses installed on the bottom of the main unit. The specification is showed on the fuse label: AC220V-240V: T200mA; AC100V-115V: T400mA; Φ5×20.
WARNING
: Ruptured fuse must only be replaced with the same type and rating as the original.
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SE-3 3-Channel Electrocardiograph User Manual
4 Operation Preparations CAUTION
:
Before use, the equipment, patient cable and electrodes should be checked. Replace it if there is any evident defectiveness or aging which may impair the safety or performance. And be sure that the equipment is in proper working condition.
4.1 Power and Earthing WARNING
:
If the integrity of external protective conductor in installation or arrangement is in doubt, the equipment should be operated from the built-in rechargeable battery. Power Supply The electrocardiograph can be powered either by mains supply or the built-in rechargeable lithium battery pack. ♦ Mains supply The mains connection socket is on the left of the unit. If mains supply used, connect the power cord to the socket first, and then connect the plug of the cord to the hospital grade outlet. Rated input voltage:
100V~115V or 220V~240V
Rated frequency:
50Hz/60Hz
Rated input power:
35VA
Make sure the mains supply meets the above requirements before power on. And then press the mains power switch to power on the unit. Then the mains supply indicator lamp ( ) will be lit. If the built-in rechargeable battery is weak when mains supply used, it will be recharged automatically at the same time. And both the mains supply indicator lamp ( ) and the battery recharging indicator lamp (
) will be lit.
♦ Built-in rechargeable battery While using the built-in rechargeable lithium battery pack, turn on the unit by pressing ON/OFF key on control panel directly and the battery indicator lamp ( The battery symbol
) will be lit.
will be displayed on the LCD screen. Because of the -20-
SE-3 3-Channel Electrocardiograph User Manual
consumption during storage and transport, the capacity of battery may not be full. If the and the hint information “BAT WEAK” are displayed, which means the
symbol
battery capacity is weak, please recharge the battery first. Please refer to the maintenance section for how to recharge the battery. During recharging the battery, SE-3 can be powered by mains supply at the same time. 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 Record Paper Two kinds of paper can be used as ECG record paper. One is Rolled thermal paper with 80mm width, and the other is folded thermal paper with 80mm width. Note: When using folded thermal paper, the Paper Roller is unnecessary, and it can be taken out. When there is no record paper loaded or it reaches the end of record paper, warning message “Paper?” will be given on the screen. Under this circumstance, record paper should be loaded or replaced immediately.
Casing
Paper Tray
Paper Roller
Thermal Print Head
Printer Platen
Groove
Loading/Replacing Process for Rolled thermal paper: 1)
Place fingers under the flange of the recorder casing, pull upwards directly to release the casing;
2)
Take out the paper roller, and remove remain paper from the left of roller if necessary; -21-
SE-3 3-Channel Electrocardiograph User Manual
3)
Take off the wrapper of thermal paper roll, and then put through the roller from the left with the paper’s grid side facing downward;
4)
Place the paper and roller gently in the recorder with the roller pin on the roller’s left side facing to the groove;
5)
Pull about 2cm of paper out, and put down the recorder casing;
6)
Secure the casing by pressing it firmly.
Loading/Replacing Process for Folded thermal paper: 1)
Place fingers under the flange of the recorder casing, pull upwards directly to release the casing;
2)
Remove residual paper in the Paper Tray if necessary;
3)
Take off the wrapper of folded thermal paper, and then put it in the Paper Tray with the paper’s grid side facing the thermal print head while put the free end of paper upright;
4)
Pull about 2cm of paper out, and put down the recorder casing;
5)
Secure the casing by pressing it firmly.
4.3 Patient Cable Connection WARNING
: The performance and electric shock protection can be guaranteed only if original EDAN patient cable and electrodes are used.
Patient cable includes two parts, main cable and lead wires with associated connectors, which can be distinguished from the color and identifier on the connectors.
Main Cable Lead Wires
Screw
Electrode Connectors
Connector
Connect Main Cable: Plug the connector of main cable into the patient cable socket on the right side of the unit according to the direction of arrow on the plug, and then secure it with two screws.
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SE-3 3-Channel Electrocardiograph User Manual
4.4 Electrodes Connections Chest Electrode:
Suction Bulb
Electrode
Metal Cup
Limb Electrode: Electrode
Reed Clamp
The identifier and color code of electrodes used complies with IEC/EN requirements. In order to avoid incorrect connections, the electrode identifier and color code is specified in Table 4-1. Moreover the equivalent code according to American requirements is given in Table 4-1 too. Table 4-1 Electrodes and their identifier and color code
European Electrodes
Identifier
American
Color code
Identifier
Color code
Right arm
R
Red
RA
White
Left arm
L
Yellow
LA
Black
Right leg
N or RF
Black
RL
Green
Green
LL
Red
Left leg
F
Chest 1
C1
Red
V1
Red
Chest 2
C2
Yellow
V2
Yellow
Chest 3
C3
Green
V3
Green
Chest 4
C4
Brown
V4
Blue
Chest 5
C5
Black
V5
Orange
Chest 6
C6
Violet
V6
Violet
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SE-3 3-Channel Electrocardiograph User Manual
As the following figure shows, the chest electrodes’ position on body surface is C1: Fourth intercostals space at right border of sternum C2: Fourth intercostals space at left border of sternum C3: Fifth rib between C2 and C4 C4: Fifth intercostals space on left midclavicular line C5: Left anterior axillary line at the horizontal level of C4 C6: Left midaxillary line at the horizontal level of C4
C1 C4
C2 C6 C3 C5
The contacting resistance between the patient and the electrode will affect the quality of ECG greatly. In order to get a high-quality ECG, the skin/electrode resistance must be minimized while connecting electrodes. WARNING
: Be sure that all electrodes have been connected to the patient correctly before operation.
WARNING
: Be sure that the conductive parts of electrodes and associated connectors, including neutral electrode, should not contact with earth or any other conducting objects.
Chest electrodes connection: 1)
Ensure the electrodes to be clean firstly;
2)
Align all lead wires of patient cable to avoid twisting, and connect the associated electrode connectors with corresponding electrodes according to the color and identifier;
3)
Clean electrode area on chest surface with alcohol;
4)
Daub the round area of 25mm diameter on each electrode site with gel evenly;
5)
Place a small mount of gel on the brim of chest electrode’s metal cup; -24-
SE-3 3-Channel Electrocardiograph User Manual
6)
Place the electrode on chest electrode site and squeeze the suction bulb. Unclench it and then the electrode is adsorbed on chest. Attach all chest electrodes in the same way.
Limb electrodes connection: 1)
Ensure the electrodes to be clean firstly;
2)
Align lead wires of patient cable to avoid twisting, and connect the electrode connectors to corresponding electrodes according to the color and identifier;
3)
Clean electrode area on a short distance above the ankle or wrist with alcohol;
4)
Daub the electrode area on limb with gel evenly;
5)
Place a small amount of gel on the metal part of limb electrode clamp;
6)
Connect the electrode to limb, and be sure that the metal part be placed on the electrode area above the ankle or wrist. Attach all limb electrodes in the same way.
4.5 Inspection before Power On In order to avoid safety hazards and get good ECG record, the following inspection procedure is recommended before power on and operation. 1) Environment: ♦
Check and make sure that there is no electromagnetic interference source around the equipment, especially large medical electrical equipment such as electrosurgical equipment, radiological equipment and magnetic resonance imaging equipment etc. Switch off these devices when necessary.
♦
Keep the examination room warm to avoid muscle action voltages in ECG signal caused by cold.
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SE-3 3-Channel Electrocardiograph User Manual
2) Power Supply: ♦
If mains power used, please check whether the power cord has been connected to the unit well. And the grounded three-phase outlet should be used.
♦ 3)
Recharge the battery first when the battery capacity is weak before use. Patient Cable:
♦
Check whether the patient cable has been connected to the unit firmly, and keep it far away from the power cord.
4) Electrodes: ♦
Check whether all electrodes have been connected to lead wires of patient cable correctly according to the identifier and color.
♦
Ensure that the chest electrodes haven’t contacted with each other.
5) Recorder Paper: ♦
Ensure that there is enough recorder paper loaded correctly.
6) Patient: ♦
The patient should not contact with conducting object such as earth, and metal part of bed etc.
♦
Ensure the patient is warm and relaxed, and breathe calmly.
WARNING
: The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained. And they should be familiar with the contents of this user manual before operation.
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5 Operation Instructions 5.1 Switching On ♦
While using mains supply, press the power switch on the left side of the unit first, and the mains supply indicator lamp (
) is lit. Then press ON/OFF key on the control panel to
turn on the unit. Equipment information such as device name and version No. will be displayed on LCD screen after self-test. Then SE-3 is ready for examination and recording. ♦
While using built-in rechargeable lithium battery, press ON/OFF key on the control panel directly to turn on the unit, and then the battery indicator (
) is lit. After self-test, SE-3 is
ready for examination and recording.
5.2 AUTO Mode Under AUTO mode, the lead groups are switched in order automatically while recording. When ECG signal of one lead group has been recorded, it will be switched to another lead group automatically and begin recording the ECG signal of that lead group. And there is a blank on the recording paper before recording the next ECG signal. Moreover, a 1mV calibration mark will be recorded at the beginning of recording. The lead group switching orders are listed in Table 3-1. Operation Method: 1) Press MODE/RST key to choose AUTO mode, which will be displayed in the top right corner on LCD screen; 2) Press MENU key to enter the Menu window to set the record settings. Press it again to return after setup; 3) Press PRINT/STOP key to begin recording. It will stop automatically after recording a full 12-lead ECG. Pressing PRINT/STOP again during the course of recording can stop recording. However, when begin recording later, ECG will be recorded from the first lead group again. And ID number will change automatically according to the current time. If the ID number needs to be unchanged, the user should adjust it before recording. Note: Whether under auto or manual mode, recording mode can not be changed during the course of recording. Stop recording before choose recording mode. -27-
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5.3 MANUAL Mode Under MANUAL mode, users should switch the lead group manually. Users can determine which lead group needs to be recorded and set the record settings or other parameters according to different lead group. Operation Method: 1) Press MODE/RST key to choose MANUAL mode, which can be discerned by the identifier in the top right corner of LCD screen; 2) Press MENU key to enter the Menu window to set the record settings. Press it again to return after setup; 3) Press LEAD left arrow or right arrow key to select leads to be recorded; 4) Press PRINT/STOP key to begin recording; 5) 1mV/COPY key can be pressed to print out 1mV mark while ECG recording; 6) Press PRINT/STOP key to stop recording after finishing ECG record. LEAD left and right arrow key can be pressed to switch the lead group during the course of recording. Pressing PRINT/STOP again during the course of recording can stop recording. However, when begin to record later, ID number will change automatically according to the current time. If the ID number needs to be unchanged, the user should adjust it before recording.
5.4 RHYTHM mode Under Rhythm mode, the user can record 60s rhythm-lead ECG waveform. 1) Press MENU key to enter the Menu window to set the RHYTHM LEAD or other settings. Press it again to return after setup; 2) Press MODE/RST key to choose RHYTHM mode; 3) Press PRINT/STOP key and the hint information “Sampling” will be displayed in the hint information field, at the same time, response time will be counted. When the response time reaches 60s, it begins to record; 4) It will stop automatically after recording a full rhythm-lead ECG waveform. Pressing PRINT/STOP again during the course of recording can stop recording.
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SE-3 3-Channel Electrocardiograph User Manual
5.5 USBPRT mode Under USBPRT mode, ECG report can be printed out through USB printer. 1) Connect SE-3 to the USB printer recommended by EDAN; 2) Press MENU key to enter Menu window to set corresponding options. Press it again to return after setup; 3) Press MODE/RST key to choose USBPRT mode; 4) Press PRINT/STOP key to begin recording. It will stop automatically after recording a full ECG report.
5.6 ECG Recall Operation 5.6.1 ECG Recall Press RECALL key to enter the recall window where patient files are saved. The recall window allows files to be stored, deleted, printed and transmitted. When there is no space for more files to be stored in the recall window, the message “MemFull” is displayed.
Recall Window (a)
0610051702 0610051718 0610051725 0710051230
TRANS ALL
Recall Window (b)
ALL to USB
USB to ECG
DEL ALL
0610051702 0610051718 0610051725 0710051230
DELETE
TRANSMIT
RECORD
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To USB
BACK
SE-3 3-Channel Electrocardiograph User Manual
Operation for ECG RECALL: 1) Press RECALL key to enter the Recall Window (a) where patient files are saved; 2) If the user wants to transmit all the files, press Up or Down to choose TRANS ALL, and then press PRINT/STOP or MENU key to transmit all the files; If the “Auto Transfer” option is not selected before transmitting, WARNING (a) will pop up to remind the user to do it first. WARNING (a)
ERROR Please Select Auto Transfer Option first! Press PRINT/STOP return YES
Note: Before transmitting patient files, please set the AUTO TRANSFER option in Menu window. Refer to 5.8.3.6 Transfer Settings for detail. 3) If the user wants to delete all the files, press Up or Down to choose DEL ALL, and then press PRINT/STOP or MENU key to pop up the WARNING(b). Then press RECALL to delete all the files or PRINT/STOP to cancel deleting;
WARNING (b)
WARNING WARNNING Do you really want to delete all the files? _________________________________ [RECALL]- >OK
[PRINT/STOP]- >CANCEL
4) If the user wants to copy all the files from the electrocardiograph to the U disk, press Up or Down to choose ALL to USB, and then press PRINT/STOP or MENU key to begin to copy; after a while, all the files will be copied into the ECGDATA folder of the U disk automatically. During the course of ALL to USB, if something wrong happens, the electrocardiograph will give the error information. And then the user should check whether the U disk is connected well, and correct it. If the user wants to import files (The extended-name should be “.dat”) from the ECGDATA folder of the U disk to the electrocardiograph, press Up or Down to choose USB to ECG, and then press PRINT/STOP or MENU key to begin to import; Note: To import files in U disk to electrocardiograph, there should be some files in the folder named ECGDATA in the U disk. The folder name “ECGDATA” must be capital letters. And the user should not change the name of files in the ECGDATA folder. -30-
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During the course of USB to ECG, if something wrong happens, the electrocardiograph will give the error information. And then the user should do the following operations: Firstly, check whether the U disk is connected well, and correct it. If the error information is still displayed, the user should check whether some files exist in the ECGDATA folder of the U disk. If nothing is found, the user should build a folder named ECGDATA in the U disk and put some files (The extended-name is “.dat”) into the ECGDATA folder. If the error information is still displayed, then the user should check whether the total number of files in the ECGDATA folder of the U disk and in the recall window of the electrocardiograph has exceeded the limit (The limit of SE-3(192 × 64 dot single color LCD screen) is 120; The limit of SE-3(320 × 240 dot single color LCD screen) is 144). If the total number has exceeded the limit, the user should remove some files from the ECGDATA folder of the U disk and then continue to import. If the error information is still displayed, then the user should check whether there are some files in the U disk having the same name with the files in the electrocardiograph. If it is true, the user should remove these files from the U disk, or delete these files in the electrocardiograph, and then continue to import. (Under this situation, this error information is “The same file found! Press PRINT/STOP return”.) After finishing importing files, the electrocardiograph will give a distinct indication. Note: The process of TRANS ALL, ALL to USB or USB to ECG needs long time to be finished, and the user should be patient to wait. During the course of copying, the U disk should not be pulled out. Note: Only FAT format should be selected when formatting the U disk. For one file, press Up, Down, Left or Right to choose one of the files in the recall window; Press PRINT/STOP or MENU key, and five operation buttons will come up on the bottom of recall window. They are DELETE, TRANSMIT, RECORD, TO USB and BACK (See Recall Window(b)); Press Up or Down to choose DELETE button, and then press PRINT/STOP or MENU key to pop up the WARNING(c). Then press RECALL to delete this file or PRINT/STOP to cancel deleting; WARNING WARNNING
WARNING (c)
Do you really want to delete this file? _________________________________ [RECALL]- >OK
[PRINT/STOP]- >CANCEL
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Press Up or Down to choose TRANSMIT button, and then press PRINT/STOP or MENU key to transmit the file; If the “Auto Transfer” option is not selected before transmitting, WARNING (a) will pop up to remind the user to do it first. Press Up or Down to choose RECORD button, and then press PRINT/STOP or MENU key to begin recording; Pressing PRINT/STOP again during the course of recording can stop recording. Note: If the user selects USBPRT mode to print, when PRINT/STOP key or MENU key is pressed, the electrocardiograph begins to analyze data, and after 8 seconds the USB printer begins to print. Note: MANUAL or RHYTHM mode can not support recall printing. If the user selects MANUAL or RHYTHM mode to record, WARNING (d) will pop up. ERROR
WARNING (d)
MANUAL or RHYTHM mode can not recall printing, Press PRINT/STOP return YES
Press Up or Down to choose To USB, and then press PRINT/STOP or MENU key to begin to copy; 5) After finish recording, press Up or Down to choose BACK button, and then press PRINT/STOP or MENU key to return to the recall window(a); 6) Press RECALL key to return to the main interface. Note: To save the ECG data to the recall window as patient files, please refer to 5.8.3.5 Save Option Settings.
5.6.2 ECG Copy Under auto mode, once the hint information “COPY” appears in the hint information field on the LCD screen, pressing 1mV/Copy key can recall the electrocardiogram that was recorded last time. Pressing PRINT/STOP during the course of recording can stop recording. Note: After recording is finished, if RECORD FORMAT or SAMPLE MODE is changed, ECG Copy is not permitted.
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5.7 Using the Menu System 5.7.1 Entering and Exiting the Menu u
Menu (320×240 dot single color)
There are four Setup windows in the menu, LOGIN, RECORD, GENERAL and SYSTEM. Press the MENU key to enter the menu. And press the MENU key again to exit the menu. LOGIN ID
RECORD
: 161105-1723
NAME :
GENERAL
HEIGHT<cm>: 170 WEIGHT<kg>: 60
AGE : 30 SEX
SYSTEM
BP<mmHg> : 80/120
: Male
HOSPITAL : DOCTOR :
ABCDEFGHIJKLM NOPQRSTUVWXYZ Prev
0123456789_DEL
Next
OK
320×240 dot single color LCD Screen u
Menu (192×64 dot single color)
Press the MENU key to enter the menu, and press the MENU key again to exit the menu. AC Filter :On EMG Filter : Off DFT Filter :0.15Hz Lowpass Filter : 100Hz 192×64 dot single color LCD Screen
5.7.2 Moving in the Sub-menus Press Up or Down to choose the setting items;
5.7.3 Parameter Modification Press Left or Right to modify a parameter; Note: When modifying Record Mode or Sensitivity on the main interface, to save the modifications, the user should enter the menu interface and exit. After that, the user will see the modifications in the main interface when he turns on the -33-
SE-3 3-Channel Electrocardiograph User Manual
electrocardiograph again.
5.7.4 Switching between the Setup Windows (only for 320×240 dot single color LCD Screen) Press Up or Down to choose Prev or Next, and then press Left or Right to switch to the previous or next setup window;
5.8 Settings (320×240 dot single color LCD screen) 5.8.1 LOGIN Settings In the LOGIN Settings window, the user can input or edit patient information. LOGIN ID
RECORD
: 161105-1723
NAME :
SYSTEM
HEIGHT (cm): 170 WEIGHT (kg): 60
AGE : 30 SEX
GENERAL
BP (mmHg) : 80/120
: Male
HOSPITAL : DOCTOR :
ABCDEFGHIJKLM NOPQRSTUVWXYZ Prev
0123456789_DEL
OK
Next
Note: The patient information can not be set or changed during the course of recording. ID
: Patient ID No.
HEIGHT (cm): Patient Height (Range: 0~255)
NAME : Patient Name (Within 11 character) WEIGHT (kg): Patient Weight (Range: 0~255) AGE
: Patient Age (Range: 0~99)
BP (mmHg): Patient Systaltic Pressure/Diastole Pressure SEX
: Patient Gender (Male/Female)
HOSPITAL: Hospital Name
DOCTOR: Doctor Name Method to enter Name: 1) Press Up or Down to choose the Name item, and a textbox will come up after the Name item; 2) Press Left or Right and the textbox will display reversed. That means the letters and -34-
SE-3 3-Channel Electrocardiograph User Manual
numbers in the pane can be selected to enter the textbox by pressing Up, Down, Left or Right. After selecting a letter or number, MENU key should be pressed to confirm. 3) If something wrong is entered, to delete wrong letter, firstly press Up, Down, Left or Right to choose the DEL item, and then press MENU key to delete the wrong letter. 4) After the name is finished, press Up, Down, Left or Right to choose OK item, and press MENU key to confirm. The user can enter HOSPITAL name and DOCTOR name with the same method above.
5.8.2 RECORD Settings LOGIN
RECORD
GENERAL
SYSTEM
LEAD SEQUENCE
:Standard
RHYTHM LEAD
:Ⅱ
SAMPLE MODE
:12CH Simultaneous
RECORD LENGTH
:Short
RECORD SPEED
:25mm/s
RECORD GRID
:Off
RECORD FORMAT
:3Ch/3Ch
RR ANALYSIS
:On
AVERAGE TEMPLT
:2×6+1R
MEASUREMENT
:On
INTERPRETATION
:On
Prev Next
5.8.2.1 Lead Settings LEAD SEQUENCE: Standard/Cabrera Lead Sequence
Lead group 1
Lead group 2
Lead group 3
Lead group 4
Standard
І, II, Ш
aVR, aVL, aVF
V1, V2, V3
V4, V5, V6
Cabrera
aVL, І, -aVR
II, aVF, Ш
V1, V2, V3
V4, V5, V6
RHYTHM LEAD: The rhythm lead can be one of 12 standard leads: І, П, Ш, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6.
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5.8.2.2 Sample Mode Settings 1CH Sequential: Lead is sampled one by one in a certain sequence. 3CH Sequential: Lead group is sampled one by one in a certain sequence. 12CH Simultaneous: All leads are sampled simultaneously.
5.8.2.3 Recording Settings RECORD LENGTH Short form means that each lead group will be recorded about 2.5 seconds. Medium form means that each lead group will be recorded about 5 seconds. Long form means that each lead group will be recorded about 7.5 seconds. Longest form means that each lead group will be recorded about 10 seconds.
RECORD SPEED Under MANUAL/RHYTHM mode, RECORD SPEED can be set as 5, 6.25, 10, 12.5, 25 or 50mm/s. Under AUTO/OFF/USBPRT mode, RECORD SPEED can be set as 25 or 50mm/s.
RECORD GRID When RECORD GRID is On, the dashed grids which are 5 mm by 5 mm will be recorded on the paper. When RECORD GRID is Off, dashed grids will not be recorded on the paper.
RECORD FORMAT When RECORD FORMAT is 3Ch/3Ch, all leads will be recorded in 4 groups of 3. When RECORD FORMAT is 3Ch/2Ch, lead I, II, III, aVR, aVL and aVF will be recorded in 2 groups of 3, and lead V1, V2, V3, V4, V5 and V6 will be recorded in 3 groups of 2.
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When RECORD FORMAT is 1Ch+1R, all leads will be recorded one by one in a sequence, with one rhythm lead at the bottom of recoding paper. When RECORD FORMAT is 1Ch, all leads will be recorded one by one in a sequence. When RECORD FORMAT is 3Ch+1R, all leads will be recorded in 4 groups of 3, with one rhythm lead at the bottom of recoding paper.
RR ANALYSIS When RR ANALYSIS is On, RR Analysis results, including RR Interval measurement information, RR Histogram and RR Trend Chart, will be recorded after rhythm wave is recorded in RHYTHM mode. When RR ANALYSIS is Off, there will be no RR Analysis results after rhythm wave is recorded in RHYTHM mode.
AVERAGE TEMPLT When AVERAGE TEMPLT is 2×6+1R/4×3, AVERAGE TEMPLT will be recorded with the format of 2×6+1R or 4×3. The format of 2×6+1R means that leads are averaged over the entire 10 second recording and recorded in 2 groups of 6, with the one rhythm lead at the bottom of page. The format of 4×3 means that leads are averaged over the entire 10 second recording and recorded in 4 groups of 3. When AVERAGE TEMPLT is Off, there will be no average template when recording.
5.8.2.4 Measurement and Interpretation In MEASUREMENT function, those common parameters, such as Heart Rate, P-R interval, QRS complex duration, Q-T interval, P/QRS/T axis, RV5/SV1 amplitude etc. can be automatically measured. The INTERPRETATION function provides automatic diagnosis for hundreds of abnormal cases, such as Arrhythmia, AV Block, Ventricular Conduction Block, Myocardial Infarction, Ventricular Hypertrophy and Atrial Enlargement, ST-T Abnormality and Electrical Axes Deviation.
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MEASUREMENT When MEASUREMENT is On, the measure information will be recorded when recording in AUTO mode. When MEASUREMENT is Off, there will be no measure information when recording.
INTERPRETATION (Optional) When INTERPRETATION is On, interpretation information will be recorded when recording. When INTERPRETATION is Off, there will be no interpretation information when recording. Note: To get the content of MEASUREMENT and INTERPRETATION, please refer to Chapter 5.9 ECG Record.
5.8.2.5 Parameter Options In the Options column, the value double underlined is default settings. No.
Items
Options
1
LEAD SEQUENCE
Standard, Cabrera
2
RHYTHM LEAD
І, II, Ш, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
3
SAMPLE MODE
1CH Sequential, 3CH Sequential, 12CH Simultaneous
4
RECORD LENGTH
Short, Medium, Long, Longest
5
RECORD SPEED
25mm/s, 50mm/s, 5mm/s, 6.25mm/s, 10 mm/s, 12.5mm/s
6
RECORD GRID
Off ,On
7
RECORD FORMAT
3Ch/3Ch, 3Ch/2Ch, 1Ch+1R, 1Ch, 3Ch+1R
8
RR ANALYSIS
Off ,On
9
AVERAGE TEMPLATE
2×6+1R, Off, 4×3
10
MEASUREMENT
Off ,On
11
INTERPRETATION(Optional) Off ,On
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5.8.3 GENERAL Settings LOGIN
RECORD
GENERAL
AC FILTER
:On
DFT FILTER
:0.15Hz
EMG FILTER
:Off
LOWPASS FILTER
:150Hz
EXTERN INP/OUTP
:Off
KEY BEEP
:On
QRS BEEP
:Off
REMOTE IP
: 192.168.1 .245
LOCAL IP
: 192.168.1 .21
AUTO TRANSFER
:Off
SAVE OPTION
:Off
SYSTEM
Prev Next
5.8.3.1 Filter Settings Four filters can be set in the GENERAL Settings window. They are: AC FILTER、DFT FILTER、EMG FILTER and LOWPASS FILTER. AC FILTER AC FILTER suppresses AC interference without attenuating or distorting the ECG. Select On to turn on the function and select Off to turn off. DFT FILTER DFT FILTER greatly reduces the baseline fluctuations without affecting the ECG signal. The purpose of this filter is to keep the ECG signals on the baseline of the printout. The setting value is the low limit of the frequency range, including 0.05Hz, 0.15Hz, 0.25Hz, 0.5Hz, and is normally set to 0.15Hz. EMG FILTER EMG FILTER suppresses disturbances caused by strong muscle tremor. The cutoff frequency is user-defined at 25Hz, 35Hz or 45Hz. Select Off to turn off the function. LOWPASS FILTER LOWPASS FILTER restricts the bandwidth of input signal. The cutoff frequency is user defined at 150Hz, 100Hz or 75Hz. All the input signals whose frequency is higher than the setting cutoff frequency will be attenuated.
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5.8.3.2 External Input/Output Settings External input/output signal interface is equipped in SE-3, through which SE-3 can receive ECG signal from external equipment, or output ECG signal to other external equipment. Set this item as On to turn on the function and Off to turn off.
5.8.3.3 Key Beep & QRS Beep Settings KEY BEEP Setting When KEY BEEP is On, a short beep sound will be made when press the control key. When KEY BEEP is Off, there is no sound while pressing the key.
QRS BEEP Setting During the course of ECG recording, if QRS BEEP is On, the unit will make a short beep sound when an R wave has been detected. So in normal recording, continuous and regular sound of beep will be heard.
5.8.3.4 IP Settings REMOTE IP IP address of the remote computer which receives ECG data from electrocardiograph through net LOCAL IP IP address of electrocardiograph
5.8.3.5 Save Option Settings When SAVE OPTION is On, the ECG data will be saved into the recall window automatically while it is being recorded in AUTO recording mode. When SAVE OPTION is Off, the ECG data will not be saved into the recall window while it is being recorded in AUTO recording mode. Note: When there is no space for more files to be stored in the recall window, the message ”MemFull” is displayed.
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SE-3 3-Channel Electrocardiograph User Manual
5.8.3.6 Transfer Settings Note: To transfer ECG data to PC machine, Smart ECG-Viewer software of EDAN must be installed in PC machine. Receive ECG Data window in the software should be opened up, transfer type should be selected, and other settings should be finished.
AUTO TRANSFER When AUTO TRANSFER is OFF, the patient files can not be transferred; When AUTO TRANSFER is UART AUTO, firstly connect the serial port of PC machine and the RS232 socket of 3-channel electrocardiograph with serial cable recommended by the manufacturer. Then open the Receive ECG Data window of Smart ECG-Viewer software in PC, select the transfer type “Serial Trans”, set the right PortNum and press Connect button. Under AUTO mode or OFF mode, ECG data can be transferred through UART port automatically after ECG recording is finished. When AUTO TRANSFER is Net AUTO, firstly connect the net interface of PC machine and the net interface of 3-channel electrocardiograph with Ethernet cable recommended by the manufacturer. Secondly open the Receive ECG Data window of Smart ECG-Viewer software in PC, select the transfer type “Net Trans” and press Connect button. Then set the REMOTE IP and LOCAL IP in Menu window in 3-channel electrocardiograph. Under AUTO mode or OFF mode, ECG data can be transferred through net automatically after ECG recording is finished.
Note: During the course of transferring or saving data, if the power supply is suddenly cut off, File System error may arise in the electrocardiograph. After the error is displayed, the user should format the File System.
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SE-3 3-Channel Electrocardiograph User Manual
5.8.3.7 Parameter Options In the Options column, the value double underlined is default settings. No.
Items
Options
1
AC FILTER
On, Off
2
DFT FILTER
0.05Hz, 0.15Hz, 0.25Hz, 0.5Hz
3
EMG FILTER
OFF, 45Hz, 35Hz, 25Hz
4
LOWPASS FILTER
150Hz, 100Hz, 75Hz
5
EXTERN INPUT/OUTPUT
On, Off
6
KEY BEEP
On, Off
7
QRS BEEP
On, Off
8
AUTO TRANSFER
Off, UART AUTO, Net AUTO
9
SAVE OPTION
On, Off
5.8.4 SYSTEM Settings
LOGIN
RECORD
DATE MODE
GENERAL
SYSTEM
: dd-mm-yyyy
DATE SETTING
: 21-07-2005
TIME SETTING
: 20:41
DEMO SETTING
: Off
LANGUAGE SETTING : English FLASH FORMAT
: Activate
RECORD TEST
: Off
DEFAULT SETTING
: Restore
PAPER STYLE
:Folded
DISPLAY MODE
:3CH
PASSWORD
:000000
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SE-3 3-Channel Electrocardiograph User Manual
5.8.4.1 Display Mode Settings Three display modes can be selected: 3CH, 6CH and 12CH. And the display interface shows as follows. 11:01:43
Female
ID: 210605-1730
Age 30
AUTO
60 R L F C1 C2 C3 C4 C5 C6 10mm/mv 25mm/s AC ON EMG OFF
3CH Display Mode
ID: 210605-1730
AUTO
Female
10mm/mV
60
Age 30
25mm/s
R L F C1 C2 C3 C4 C5 C6
6CH Display Mode -43-
11:01:43
SE-3 3-Channel Electrocardiograph User Manual
ID: 210605-1730
AUTO
Female
10mm/mV
Age 30
25mm/s
60
11:01:43
R L F C1 C2 C3 C4 C5 C6
12CH Display Mode
DATE MODE: Date mode can be set as dd-mm-yyyy, mm-dd-yyyy or yyyy-mm-dd. After set, the current date format will change according to the DATE MODE you selected. DATE&TIME SETTING: Set current Date and time. It will be recorded on the record paper. DEMO SETTING: Select On to enter the Demo mode. LANGUAGE SETTING: The user can set the system language. FLASH FORMAT: Select Activate to pop up the WARNING “Do you really want to format the file system?” And then press RECALL key to format the file system; press PRINT/STOP key to cancel operation. RECORD TEST: Press Left or Right to start record test when the record paper has been loaded. Then the triangle wave in effective paper width will be recorded. The status of print head can be estimated from this triangle wave. Press Left or Right again to stop record test. DEFAULT SETTING: Select Restore to resume default setting value. Note: In the Parameter Options Column, some parameters’ options have no underline, which means these parameters have no default settings. And when the user restores default settings, these parameters will not change. PAPER STYLE: Record paper style. Rolled thermal paper and folded thermal paper can be selected as record Paper. Note: If the user sets the PAPER STYLE as Folded paper, when recording in Auto mode or RHYTHM mode, recording will not stop until a black sign is met.
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