EDAN INSTRUMENTS SE-3 Service Manual

EDAN INSTRUMENTS SE-3 Service Manual

3-channel electrocardiograph
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EDAN INSTRUMENTS, INC
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Manual Ver: V1.3
Release Date: Aug. 2008
Part Number: MS1R-20094-V1.3

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Summary of Contents for EDAN INSTRUMENTS SE-3

  • Page 1 EDAN INSTRUMENTS, INC Manual Ver: V1.3 Release Date: Aug. 2008 Part Number: MS1R-20094-V1.3...
  • Page 2 © 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.
  • Page 3 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.
  • Page 4: Table Of Contents

    Table of Contents Chapter 1 General ........................1 1.1 Function Features ......................1 1.2 Environment Requirement ....................2 1.3 Power Supply Requirement..................... 2 Chapter 2 Appearance Views ....................3 2.1 Top Panel......................... 3 2.2 Patient Cable Socket and Signal Interface ..............3 2.3 Mains Connection and Switch..................
  • Page 5 6.1 Power and Earthing ....................... 27 6.2 Loading/Replacing Record Paper.................. 28 6.3 Patient Cable Connection....................29 6.4 Electrodes Connections ....................30 6.5 Inspection before Power On..................32 Chapter 7 Cleaning ........................34 7.1 Clean..........................34 7.1.1 Clean the Main Unit and Patient Cable............... 34 7.1.2 Clean the Electrodes....................
  • Page 6: Chapter 1 General

    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.
  • Page 7: Environment Requirement

    SE-3 3-Channel Electrocardiograph Service Manual ♦ Standard input/output interface and RS232 communication interface for linking to special network and setting up ECG database 1.2 Environment Requirement The environment requirements are listed in the following table. Transport & Storage Working Temperature: -20℃~+55℃...
  • Page 8: Chapter 2 Appearance Views

    SE-3 3-Channel Electrocardiograph Service Manual Chapter 2 Appearance Views 2.1 Top Panel Smart ECG SE-3 LCD Screen Record Paper USB Interface Recorder External Input/Output Control Panel Socket RS232 Socket Patient Cable Socket Figure 2-1 Main Unit (320×240 dot single color LCD Screen) 2.2 Patient Cable Socket and Signal Interface...
  • Page 9 SE-3 3-Channel Electrocardiograph Service Manual Definition of corresponding pins: Signal Signal Signal C2 (input) F (input) C3 (input) C4 (input) C1(input) C5 (input) R (input) C6 (input) L (input) 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.
  • Page 10: Mains Connection And Switch

    SE-3 3-Channel Electrocardiograph Service Manual 4) USB Interface Definition of corresponding pins: Signal Signal VBUS WARNING : Only the USB equipments recommended by EDAN can be connected to the USB interface. 2.3 Mains Connection and Switch Potential equalization terminal Mains Power Switch Mains Supply Socket 2.4 Bottom Panel...
  • Page 11: Chapter 3 Principle

    SE-3 3-Channel Electrocardiograph Service Manual Chapter 3 Principle 3.1 Abstract of theory of ECG operation The heart is a power organ of the body blood circulation. Before the systole or diastole, a cardiac impulse happens in the heart muscle, and a faint bioelectric current signal is thus generated. The...
  • Page 12: Lead

    SE-3 3-Channel Electrocardiograph Service Manual Figure 3-1 Composition of ECG P wave: the sequential activation (depolarization) of the right and left atria QRS complex: right and left ventricular depolarization (normally the ventricles are activated simultaneously) ST-T wave: ventricular repolarization U wave: origin for this wave is not clear - but probably represents "after-depolarizations"...
  • Page 13 SE-3 3-Channel Electrocardiograph Service Manual Each of the 12 leads represents a particular orientation in space, as indicated below (RA = right arm; LA = left arm, LL = left leg): Bipolar limb leads (frontal plane): Lead I: RA (-) to LA (+) (Right Left, or lateral)
  • Page 14: Hardware Design Principle Description

    V6: horizontal to V5, mid-axillary line Figure3-3 Chest electrode of the standard limb leads 3.4 Hardware Design Principle Description The SE-3 electrocardiograph consists of the following functional blocks: Keyboard panel for user input/output; Front_end module including signal acquisition, digital filter and the amplifier;...
  • Page 15: Ecg Board Description

    SE-3 3-Channel Electrocardiograph Service Manual Figure 3-4 SE-3 machine block diagram 3.4.1 ECG Board description Figure3-5 ECG Board circuit block diagram -10-...
  • Page 16: Main Control Part Description

    SE-3 3-Channel Electrocardiograph Service Manual This module is a 12-channel ECG signal sampling and processing module. It can realize the amplification and pre-processing of patient ECG signal in every channel, and the detection of lead situations, as well as sending data to ARM9 MCU. This module is connected to ARM9MCU through UART port.
  • Page 17: Power Control Part Description

    SE-3 (Configuration A) uses 192*64 LCD screen that adopts 8 bit bus interface. The mainboard of SE-3 uses 8 GPIO to simulate 8 bit buses to control the reading and writing of LCD screen. SE-3 (Configuration B) uses 320*240 LCD screen that adopts standard FSTN interface. Because ARM9 has the FSTN interface of its own, it can be drived directly after connected.
  • Page 18: Chapter 4 Tests

    SE-3 3-Channel Electrocardiograph Service Manual Chapter 4 Tests 4.1 System Tests 1. Unit appearance and assembly examinations 1) Clean appearance, firm assembly, no remainder in the unit when shaking it. 2) Keys feel well when pressing. 3) Labels are full and correct.
  • Page 19 SE-3 3-Channel Electrocardiograph Service Manual system will be shifted to the main interface automatically. And then enter the corresponding interfaces of the System Setup window to set the current time and change some menu options and exit. Turn off the electrocardiograph, and turn on it five seconds later. When the electrocardiograph is ready for examination and recording, observe if the time displayed on the LCD screen is the current time.
  • Page 20: Safety Tests

    SE-3 3-Channel Electrocardiograph Service Manual 4.3 Safety Tests 1) Test the protection earth resistance according to IEC/EN 60601-1: Limit 0.1 ohm. 2) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 uA, SFC 1000uA. 3) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10 uA (CF).
  • Page 21: Chapter 5 Electrocardiograph Servicing

    SE-3 3-Channel Electrocardiograph Service Manual Chapter 5 Electrocardiograph Servicing 5.1 Disassembly Steps 1. View of whole machine 2. Disassembly steps of the whole machine and recorder casing Remove the crosshead screws ① (M3×10) in the four corners of the bottom of electrocardiograph.
  • Page 22 SE-3 3-Channel Electrocardiograph Service Manual lower casing of the displaying box, filmy switch panel, LCD screen, rotation base etc. The disassembly steps: Remove the cables between LCD screen ⑩, filmy switch panel ⑨ and transfer board ②.→Remove the five crosshead panhead screws ① (M3×6), and dismantle the transfer board ②→Remove the four crosshead panhead screws ⑤...
  • Page 23 SE-3 3-Channel Electrocardiograph Service Manual 5. The picture of lower unit 6. Disassembly steps of the lower unit Remove the cables between two parts before disassembly. Remove the transfer board of power supply ⑨ which is embedded in the groove of the lower unit→ Remove screws to dismantle the interface board ⑧...
  • Page 24: Internal Boards And Interfaces

    SE-3 3-Channel Electrocardiograph Service Manual 5.2 Internal Boards and Interfaces 1. ECG board—receiving and processing ECG signals ① ① P2--socket connected to the interface board -19-...
  • Page 25 SE-3 3-Channel Electrocardiograph Service Manual Description Description Digital signal (output) RxD (input) TxD (output) 2. Interface board—integrating power supplies and input/output interfaces ① ② ③ ④ -20-...
  • Page 26 SE-3 3-Channel Electrocardiograph Service Manual ① CON11-- Socket connected to ECG board. Please refer to P2 socket of ECG board for pin information. ② CON12-- Interface connected to recorder. Description Draw to GND 2, 15 Paper Detection Temperature Detection 4, 5, 24...
  • Page 27 SE-3 3-Channel Electrocardiograph Service Manual H: DISPLAY ON 6, 7, 8, 9, 21 Control Signal of LCD Screen 10, 40 11, 21, 22, 27, 34, 35 12, 15~19, 23, 24 Analog Signal Input Restoration Signal 25, 26, 28~33 Control Signal of Filmy Switch Panel...
  • Page 28: Troubleshooting

    SE-3 3-Channel Electrocardiograph Service Manual 3. ARM9 board—LCD display control, data process, ECG analysis 5.3 Troubleshooting The electrocardiograph is a complicated electrical device and it is difficult for even an experienced person to repair the internal hardware failure. The manufacture does not recommend the user to repair it.
  • Page 29 SE-3 3-Channel Electrocardiograph Service Manual ① strong interference of ① Inspect Power supply and electric networks ② ARM9 board failure earthing system Out of work ③ Power supply or ② Change ARM9 board ③ Change or repair plug-in unit plug-in unit on the master control board failure ①...
  • Page 30 SE-3 3-Channel Electrocardiograph Service Manual 4. Operation troubles Fault symptoms Possible cause Correction action ① Key board is damaged ① Change key board Key failure ② ARM9 board failure ② Change ARM9 board No Key Beep or Key Beep is ①...
  • Page 31 SE-3 3-Channel Electrocardiograph Service Manual 5. Parameter troubles Fault symptoms Possible cause Correction action ① Install electrode clamp ① Electrode clamp is not again or clean electrode area installed well. on body surface with alcohol ② Patient cable is loose Without ECG waveform ②...
  • Page 32: Chapter 6 Electrocardiograph Installation

    SE-3 3-Channel Electrocardiograph Service Manual Chapter 6 Electrocardiograph Installation 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.
  • Page 33: Loading/Replacing Record Paper

    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.
  • Page 34: Patient Cable Connection

    SE-3 3-Channel Electrocardiograph Service Manual Place the paper and roller gently in the recorder with the roller pin on the roller’s left side facing to the groove; Pull about 2cm of paper out, and put down the recorder casing; Secure the casing by pressing it firmly.
  • Page 35: Electrodes Connections

    SE-3 3-Channel Electrocardiograph Service Manual 6.4 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.
  • Page 36 SE-3 3-Channel Electrocardiograph Service Manual 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...
  • Page 37: Inspection Before Power On

    SE-3 3-Channel Electrocardiograph Service Manual then the electrode is adsorbed on chest. Attach all chest electrodes in the same way. Limb electrodes connection: Ensure the electrodes to be clean firstly; Align lead wires of patient cable to avoid twisting, and connect the electrode connectors to corresponding electrodes according to the color and identifier;...
  • Page 38 SE-3 3-Channel Electrocardiograph Service Manual ♦ 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.
  • Page 39: Chapter 7 Cleaning

    SE-3 3-Channel Electrocardiograph Service Manual Chapter 7 Cleaning 7.1 Clean CAUTION Turn off the power before cleaning and disinfection. Mains supply must be switch off if it has been in use. 7.1.1 Clean the Main Unit and Patient Cable The surface of the main unit and patient cable can be wiped with a clean soft cloth damped in soapy water or non-caustic neutral detergent.
  • Page 40: Disinfection

    SE-3 3-Channel Electrocardiograph Service Manual 7.2 Disinfection To avoid permanent damage to the equipment, disinfection can be performed only when it has been considered as necessary according to your hospital’s regulations. Before disinfection clean the equipment first. Then wipe the surface of the unit and patient cable with hospital standard disinfectant.
  • Page 41: Chapter 8 Maintenance

    ( ) will usually be black. But if SE-3 is power off, the lamp will still lit just because the equipment will not monitor the recharge status; so you need to power on the device to verify the status.
  • Page 42: Record Paper

    SE-3 3-Channel Electrocardiograph Service Manual connecting the battery. ♦ When the battery’s useful life is over, contact with the manufacturer or local distributor for disposal or dispose the battery according to local regulations. 8.2 Record Paper Note: Record paper provided by manufacturer should be used. Other paper may shorten thermal print head’s life.
  • Page 43 SE-3 3-Channel Electrocardiograph Service Manual equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired. WARNING Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.
  • Page 44: Chapter 9 Technical Specifications

    SE-3 3-Channel Electrocardiograph Service Manual Chapter 9 Technical Specifications Safety 1) EN 60601-1: 1990(A1 + A2), Standards 2) IEC/EN 60601-1-2: 2001, 3) IEC/EN 60601-2-25, 4) ANSI/AAMI EC-11. Classification Class І with internal power supply Anti-electric-shock type: Anti-electric-shock degree: Type CF...
  • Page 45 SE-3 3-Channel Electrocardiograph Service Manual Pack: Rated capacity = 2000mAh /2200mAh /2400mAh When the capacity of battery is full, SE-3 can work continuously at least 249 minutes. Charge mode: Constant current/voltage Charge current (standard) = 0.2C A (320mA) Charge voltage (standard) = (17±0.1V) Cycle life ≥...
  • Page 46 SE-3 3-Channel Electrocardiograph Service Manual Calibration Voltage: 1mV±3% <12.5 µ Vp-p Noise: ≤0.5mm Multichannel crosstalk AC Filter: On/Off DFT Filter: 0.05/0.15/0.25/0.5 Filter EMG Filter: 25Hz/35Hz/OFF LOWPASS Filter:150Hz/100Hz/75Hz ≥110dB CMRR Sampling Frequency 1000Hz <10 µ A (220V~240V) Patient Leakage Current: <0.1 µ A (DC)
  • Page 47 EDAN INSTRUMENTS, INC. 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan Shenzhen, 518067 P.R. China TEL:86-755-26882220 FAX: +86-755-26882223 EC REPRESENTATIVE Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, D-20537 Hamburg Germany TEL: +49-40-2513175 FAX: +49-40-255726 E-mail: antonjin@yahoo.com.cn...

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