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EDAN INSTRUMENTS, INC

Manual Ver: V1.3
Release Date: Aug. 2008
Part Number: MS1R-20094-V1.3

-3

Содержание SE-3

Страница 1: ...EDAN INSTRUMENTS INC Manual Ver V1 3 Release Date Aug 2008 Part Number MS1R 20094 V1 3 SE 3 3 ...

Страница 2: ...fer 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 c...

Страница 3: ...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 ...

Страница 4: ... 3 1 Abstract of theory of ECG operation 6 3 2 Composition of ECG 6 3 3 Lead 7 3 4 Hardware Design Principle Description 9 3 4 1 ECG Board description 10 3 4 2 Main control part description 11 3 4 3 Power control part description 12 Chapter 4 Tests 13 4 1 System Tests 13 4 2 Application System Tests 13 4 3 Safety Tests 15 Chapter 5 Electrocardiograph Servicing 16 5 1 Disassembly Steps 16 5 2 Inter...

Страница 5: ...ower 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 34 7 1 3 Clean the Print Head 34 7 2 Disinfection 35 Chapter 8 Maintenance 36 8 1 Recharge and Replacement of Battery 36 8 2 Record Paper 37 8 3 Maintenance of Main Unit Patient Cable Electrodes 37 Chapter 9 Technical Specifications 39 ...

Страница 6: ...size makes it suitable for clinic hospital and ambulance use Configurations Main unit and accessories power cord earth wire patient cable electrodes and thermal recording paper Note It is not designed for internal use and direct cardiac application 1 1 Function Features Low weight and compact size Touch key for easy operation High resolution thermal recorder recording frequency response 150Hz 12 l...

Страница 7: ...ort Storage Working Temperature 20 55 5 40 Relative Humidity 25 93 Non Condensing 25 80 Non Condensing Atmospheric Pressure 700hPa 1060hPa 860hPa 1060hPa 1 3 Power Supply Requirement Power Supply 1 Mains Supply Rated input voltage 100V 115V 220V 240V Rated frequency 50Hz 60Hz Rated input power 35VA 2 Built in Rechargeable Lithium Battery Pack Rated voltage 14 8V 3 Power Consumption 35VA 4 Fuse Spe...

Страница 8: ... 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 2 1 shows 1 Patient Cable Socket Applied part of type CF with defibrillator proof Attention see accompanying document LCD Screen Patient Cable Socket Smart ECG SE 3 Record Paper RS232 Socket Recorder Control Panel External Input Output Socket USB Inte...

Страница 9: ...t 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 Signal 1 GND 4 GND 2 GND 5 ECG Signal...

Страница 10: ...l Pin Signal 1 VBUS 3 D 2 D 4 GND WARNING Only the USB equipments recommended by EDAN can be connected to the USB interface 2 3 Mains Connection and Switch 2 4 Bottom Panel Mains Power Switch Potential equalization terminal Mains Supply Socket Fuse Mains Supply Shift Switch Fuse Label Battery Compartment Label ...

Страница 11: ...ted electrodes at certain specific locations on the body They only record the heart s electrical activity They do not produce any electricity of their own The test does not hurt and has no known side effects It does not require any preparation except for possibly shaving chest hair to get a better recording The recording itself takes only a few seconds There has been more than one hundred years si...

Страница 12: ...PR interval time interval from onset of atria depolarization P wave to onset of ventricular depolarization QRS complex QRS duration duration of ventricular muscle depolarization QT interval duration of ventricular depolarization and repolarization RR interval duration of ventricular cardiac cycle an indicator of ventricular rate PP interval duration of atria cycle an indicator or atria rate 3 3 Le...

Страница 13: ...d III LA to LL Superior Inferior Augmented unipolar limb leads frontal plane Lead aVR RA to LA LL Rightward Lead aVL LA to RA LL Leftward Lead aVF LL to RA LA Inferior Unipolar chest leads horizontal plane Leads V1 V2 V3 Posterior Anterior Leads V4 V5 V6 Right Left or lateral Figure 3 2 Standard limb leads RA right arm LA Left arm LL left Leg V1 right 4th intercostal space V2 left 4th intercostal ...

Страница 14: ... of the standard limb leads 3 4 Hardware Design Principle Description The SE 3 electrocardiograph consists of the following functional blocks 1 Keyboard panel for user input output 2 Front_end module including signal acquisition digital filter and the amplifier 3 ARM9 and peripheral module 4 Thermal Printer module 5 LCD display module 6 Power supply module ...

Страница 15: ...SE 3 3 Channel Electrocardiograph Service Manual 10 Figure 3 4 SE 3 machine block diagram 3 4 1 ECG Board description Figure3 5 ECG Board circuit block diagram ...

Страница 16: ...ond level amplification and are sent to the A D sampling port of MSP430F147 Because the ECG system must meet the safety requirement of the photo electricity isolation the serial signals will be sent to the photo electricity component 3 4 2 Main control part description The main control part includes ARM9 Board and Interface Circuit Board ARM9 Board consists of MCU S3C2410 SDRAM NAND FLASH NOR FLAS...

Страница 17: ...iode The keyboard uses filmy keys and the keyboard control component uses 3 4 matrixes 12 keys in total 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 interf...

Страница 18: ...e if some characters are missing or there are bright spots and dark shadows on the LCD screen Observe if the waveforms fonts and symbols displayed on the LCD screen are normal 3 Lead off tests Under AUTO mode when pull out and insert the lead cables according to the sequence of the lead cables inserted into the ECG emulator the electrocardiograph will accurately identify the disconnection and conn...

Страница 19: ...will give the hint information of Heart Rate exceeding the limit and make an alarm sound 7 Recording tests 1 Set the following values The heart rate output of ECG emulator is 80bpm the work mode of electrocardiograph is auto the speed is 25mm s the AC Filter is off the Lowpass Filter is 150Hz and all the options in the Record Setting menu are on Install the recording paper and press PRINT STOP key...

Страница 20: ...0601 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 4 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 ...

Страница 21: ...10 in the four corners of the bottom of electrocardiograph Open the upper unit and remove the cables between the upper and lower unit and then separate the upper unit from the lower In the following pictures is the lower unit and is the recorder casing 3 Disassembly steps of the upper unit Configuration A 192 64 dot single color LCD screen The upper unit of the electrocardiograph 192 64 dot single...

Страница 22: ...ead sunk screws M3 6 to dismantle the rotation base The label 11 and filmy switch panel are sticked to the upper unit and can be torn off Note The LCD screen should be protected from being damaged when disassembling it 4 Disassembly steps of the upper unit Configuration B 320 240 dot single color LCD screen The difference between disassembling Configuration A and B is that the LCD screen of Config...

Страница 23: ...ly Remove the transfer board of power supply which is embedded in the groove of the lower unit Remove screws to dismantle the interface board and ECG board Remove crosshead panhead screws M3 8 and dismantle the transformer Remove the two crosshead panhead screws M2 6 and dismantle the print head Remove the four crosshead sunk screws M3 6 and dismantle the print bracket ...

Страница 24: ...SE 3 3 Channel Electrocardiograph Service Manual 19 5 2 Internal Boards and Interfaces 1 ECG board receiving and processing ECG signals P2 socket connected to the interface board ...

Страница 25: ...Channel Electrocardiograph Service Manual 20 Pin Description Pin Description 1 Digital signal output 2 GND 3 RxD input 4 TxD output 5 5V 2 Interface board integrating power supplies and input output interfaces ...

Страница 26: ... Pin Description 1 Draw to GND 2 15 5V 3 Paper Detection 16 Temperature Detection 4 5 24 NC 6 7 25 26 8V 8 Data Output 9 Clock Output 10 11 19 20 21 22 GND 12 13 14 17 18 23 Control Signal Input valid in low electrical level 27 28 29 30 Drive Signal of Electric Motor CON8 Interface of LCD Configuration B Pin Description 1 2 3 4 Data Signal of LCD Screen 5 LCD Displays control signal ...

Страница 27: ... Battery Recharging Indicator Signals Analog Signal 38 Battery Indicator Signals Analog Signal CON7 Interface of LCD Configuration A Pin Description 1 2 23 24 NC 3 22 27 34 35 GND 4 5V 5 6 Analog Signal Input 7 8 11 12 21 Control Signal of LCD Screen 9 Restoration Signal 10 13 20 Data Signal of LCD Screen 25 26 28 33 Control Signal of Filmy Switch Panel 36 Mains Supply Indicator Signals Analog Sig...

Страница 28: ...the suitable actions for correcting the problems or replacing the accessory or calling the service person It can also help the user to have more exact descriptions of the fault symptoms when call for service which greatly makes the service fast and efficient 1 Troubles of the whole machine Fault symptoms Possible cause Correction action Can not turn on the electrocardiograph with mains supply Fuse...

Страница 29: ...uited Change this component 2 Display troubles Fault symptoms Possible cause Correction action Some characters displayed on the LCD screen are missing LCD screen failure Change LCD screen LCD screen is dark The brightness of interface board is not adjusted well LCD screen failure Adjust the adjustable transformer VR1 in the interface board Change LCD screen 3 Transmission troubles Fault symptoms P...

Страница 30: ...ce board Change or repair recorder connection cord Recording is illegible Install the paper roller on the print head directly If recording becomes clear you can confirm that the recorder is not installed well If still illegible print head is failure Adjust the installation of recorder Change print head Some characters or waveform recorded are missing Print head has stain Print head failure Clean p...

Страница 31: ...patient cable with the unit Change ECG board ECG waveform is abnormal or disturbed Electrode clamp is not installed well Patient cable failure ECG board failure Install electrode clamp again or clean electrode area on body surface with alcohol Change patient cable Change ECG board Heart rate is not accurate Waveform measuring failure Adjust connections ECG waveform has burr Electrode clamp is not ...

Страница 32: ...nnect 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 w...

Страница 33: ...r 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 Loading Replacing Process for Rolled thermal paper 1 Place fingers under the flange of...

Страница 34: ...he 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 6 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...

Страница 35: ...ments is given in Table 4 1 too Table 4 1 Electrodes and their identifier and color code European American Electrodes Identifier 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 Left leg F Green LL Red 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 C...

Страница 36: ...l 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 associa...

Страница 37: ...etal part be placed on the electrode area above the ankle or wrist Attach all limb electrodes in the same way 6 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 lar...

Страница 38: ...rectly 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 th...

Страница 39: ... limb electrodes apart Clean them in warm water and be sure there is no remainder gel Dry the electrodes with a clean dry cloth or air dry naturally 7 1 3 Clean the Print Head Dirty and soiled thermal print head will deteriorate the record definition So it should be cleaned at least once a month regularly Open the recorder casing and remove the paper Wipe the print head gently with a clean soft cl...

Страница 40: ...n 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 CAUTION Do not use chloric disinfectant such as chloride and sodium hypochlorite etc ...

Страница 41: ...charging the symbol will flash in the top right corner of LCD screen When the capacity of battery is full the symbol will stop flashing and the battery recharge indicator lamp 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 Because of the capacity consumpti...

Страница 42: ... record may trans print each other 8 3 Maintenance of Main Unit Patient Cable Electrodes 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 a Inspect the equipment and accessories for mechanical and functional damage b Inspect the safety relevant labels for legibility c I...

Страница 43: ...hould be checked regularly And be sure that it is conductible Do not drag or twist the patient cable with excessive stress while using Hold the connector plugs instead of the cable when connect or disconnect the patient cable Align the patient cable to avoid twisting knotting or crooking in closed angle while using Store the lead wires in bigger wheel to prevent any people from stumbling Once dama...

Страница 44: ...details Degree of safety of application in the presence of flammable gas Equipment not suitable for use in the presence of flammable gas Working mode Continuous operation Classification EMC Group І type A Dimensions 288mm 210mm 70mm Weight About 2 5kg Display 320 240 dot single color LCD Screen 192 64 dot single color LCD Screen Transport Storage Working Temperature 20 55 5 40 Relative Humidity 25...

Страница 45: ... 20 Recorder Thermal dot matrix printer Record Paper Folded thermal paper 80mm width Rolled thermal paper 80mm width Effective Width 72mm Paper Speed 5mm s 10mm s 12 5mm s 25mm s 50mm s 3 Recording Accuracy of data 5 x axis 5 y axis Technique Peak peak detection HR Range 30 BPM 300 BPM HR Recognition Accuracy 1BPM Leads 12 standard leads Acquisition Mode simultaneously 12 leads A D Resolution 12 b...

Страница 46: ...er 0 05 0 15 0 25 0 5 EMG Filter 25Hz 35Hz OFF Filter LOWPASS Filter 150Hz 100Hz 75Hz CMRR 110dB Sampling Frequency 1000Hz Patient Leakage Current 10 µ A 220V 240V Patient Auxiliary Current 0 1 µ A DC Dielectric Strength 4000V rms Input 100kΩ Sensitivity 10mm V 5 Single ended External Input Output Optional Output 100Ω Sensitivity 1V mV 5 Single ended ...

Страница 47: ...nhai 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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