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SE-3 3-Channel Electrocardiograph User Manual

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5.10 RHYTHM mode record

(a)

(b)

Figure (a) shows the following content:

10mm/mV (Sensitivity)

0.15~100Hz (Filter information)

AC50 (50Hz AC Filter)

(1mV calibration mark)

II (Lead name

）

60 seconds rhythm waveform of lead II

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Summary of Contents for SE-3

Page 1: ...EDAN INSTRUMENTS INC Manual Ver V1 7 Release Date Aug 2008 Part Number MS1R 20055 V1 7 SE 3 3 ...

Page 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...

Page 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 ...

Page 4: ... 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...

Page 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 ...

Page 6: ...LICY 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 ...

Page 7: ...nd 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 flammabl...

Page 8: ...ence 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 thi...

Page 9: ... 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 ve...

Page 10: ... 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 ...

Page 11: ...og 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 orde...

Page 12: ... 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 an...

Page 13: ...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 par...

Page 14: ... 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 ...

Page 15: ...cal 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 physicia...

Page 16: ...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 LCD Screen Patient Cable Socket Smart ECG SE 3 Record Paper RS232 Socket Recorder Control Panel External Input Output Socket USB Interface ...

Page 17: ...ate 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 Actual 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 manual mode and auto sensitivity symbol w...

Page 18: ...TO 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 Actual heart rate Battery capacity Only when the built in battery is used Third Row ECG wave 3 1 2 Contr...

Page 19: ... 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...

Page 20: ...d to press Lead Switch Key to change the lead the 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 int...

Page 21: ...ch 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...

Page 22: ... 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 ...

Page 23: ...ssing 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 ...

Page 24: ...cket AC SOURCE alternating current supply socket 3 Power Switch Switch on Switch off 3 4 Bottom Panel 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 Fuse Mains Supply Shift Switch Fuse Label Battery Compartment L...

Page 25: ...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...

Page 26: ...f 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 lam...

Page 27: ...oading 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 Und...

Page 28: ... 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 an...

Page 29: ...ent code according to American requirements 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 Brow...

Page 30: ...de 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 firstl...

Page 31: ...lace 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...

Page 32: ... 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 an...

Page 33: ... 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 ...

Page 34: ...d 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 ...

Page 35: ...in 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 Recall Window...

Page 36: ...ress 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 want...

Page 37: ...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 electroca...

Page 38: ...lects MANUAL or RHYTHM mode to record WARNING d will pop up WARNING d 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 patie...

Page 39: ...4 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 tu...

Page 40: ...g 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 a...

Page 41: ... to confirm The user can enter HOSPITAL name and DOCTOR name with the same method above 5 8 2 RECORD Settings 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...

Page 42: ...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 da...

Page 43: ...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 wil...

Page 44: ... 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 ...

Page 45: ...etting 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...

Page 46: ...se 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...

Page 47: ... 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 ...

Page 48: ... 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 GENERAL LOGIN RECORD SYSTEM DATE MODE 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 Folde...

Page 49: ...des can be selected 3CH 6CH and 12CH And the display interface shows as follows ID 210605 1730 Female Age 30 AUTO 11 01 43 60 R L F C1 C2 C3 C4 C5 C6 10mm mv 25mm s AC ON EMG OFF 3CH Display Mode ID 210605 1730 Female Age 30 60 11 01 43 AUTO 10mm mV 25mm s R L F C1 C2 C3 C4 C5 C6 6CH Display Mode ...

Page 50: ...m 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 Opti...

Page 51: ...ngle color Note The common menu items of the two kinds of device have common functions Please refer to the function explanation of 320 240 dot single color LCD screen 192 64 dot single color LCD Screen Press Up or Down to switch to the next setting interface and view the setting items The setting items in the menu of 192 64 dot single color LCD screen are as follows No Items Explanation 1 AC Filte...

Page 52: ... Paper Style Refer to Chapter 5 8 4 17 Save Option Refer to Chapter 5 8 3 5 18 Auto Transfer Refer to Chapter 5 8 3 6 19 Local IP 20 Remote IP Refer to Chapter 5 8 3 4 21 Key Beep 22 QRS Beep Refer to Chapter 5 8 3 3 23 Extern Inp Outp Refer to Chapter 5 8 3 2 24 Record Test 25 Demo Setting 26 Language Setting 27 Flash Format 28 Default Setting 29 Data Mode 30 Date Setting 31 Time Setting Refer to...

Page 53: ...SE 3 3 Channel Electrocardiograph User Manual 47 5 9 AUTO mode record a b c ...

Page 54: ... R interval from several of 12 selected dominant beats QRS Dur QRS complex duration mean of duration of QRS complexes from several of 12 selected dominant beats QT QTC int Q T interval mean of Q T interval from several of 12 selected dominant beats Normalized QT interval P QRS T axis dominant direction of the average integrated ECG vectors RV5 SV1 amP The maximum of amplitude of R or R wave of one...

Page 55: ...ograph User Manual 49 5 10 RHYTHM mode record a b Figure a shows the following content 10mm mV Sensitivity 0 15 100Hz Filter information AC50 50Hz AC Filter 1mV calibration mark II Lead name 60 seconds rhythm waveform of lead II ...

Page 56: ...ormation includes the following content Current Date Current Time Patient Information ID Name Age Sex BP Height Weight Measure Time Total R Num Total R wave number HR Heart Rate RR Avg Interval Average RR interval RR Max Interval Maximum RR interval RR Min Interval Minimum RR interval Max Min Ratio of Maximum RR interval to Minimum RR interval SDNN Standard Deviation of Normal to Normal Intervals ...

Page 57: ...SE 3 3 Channel Electrocardiograph User Manual 51 5 11 USBPRT mode record ...

Page 58: ...nformation Unconfirmed Report Review By ECG waveform of 12 leads 5 12 Switch Off When built in battery pack used press ON OFF key directly to turn off the unit after finishing ECG record When mains supply used press ON OFF key first after finishing ECG record and then switch off the mains supply by pressing the switch on the left side of the unit Pull off the plug from the outlet last Note When sw...

Page 59: ...d paper has not been loaded or it has been run out PaperErr Feed paper error Sampling Printing ECG signal is being sampled Printed Modu Err There is something wrong with the signal sample module Demo The system is in demonstration mode Copy The ECG data recorded last time is ready to be reviewed Process The ECG data is being processed Transfer The patient file in recall window is being transferred...

Page 60: ... 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 93 Non Condensing 25 80 No...

Page 61: ...ecord Paper Folded thermal paper 80mm width Rolled thermal paper 80mm width Effective Width 72mm Paper Speed 5mm s 6 25mm 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 bits Time Constant 3 2s Frequency...

Page 62: ...05 0 15 0 25 0 5 EMG Filter 25Hz 35Hz 45Hz 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 ...

Page 63: ...the 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 8 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...

Page 64: ...arning message BAT WEAK will be displayed on LCD screen The battery should be recharged immediately 2 Recharge SE 3 is equipped with recharge control circuit together with built in rechargeable lithium battery When connect with the mains supply the battery will be recharged automatically And then the battery recharge indicator lamp and the mains supply indicator lamp will be lit at the same time D...

Page 65: ...isposal or dispose the battery according to local regulations 8 3 2 Record Paper Note Record paper provided by manufacturer should be used Other paper may shorten thermal print head s life And the deteriorated print head may lead to illegible ECG record and block the advance of paper etc Storage requirements Record paper should be stored in dry dark and cool area avoiding excessive temperature hum...

Page 66: ...e 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 1 Main Unit Avoid excessive temperature sunshine humidity and dirt Put on the dustproof coat after use and prevent from shaking violently when ...

Page 67: ...b of chest electrode from sunshine and excessive temperature After long term use the surface of electrodes will be oxidized because of erosion and other causes By this time electrodes should be replaced to achieve high quality ECG CAUTION The equipment should be sent to the special agencies according to local regulation for separate collection after its useful life ...

Page 68: ...DEN MS1 18504 4 Limb electrodes Tsingtao KOHDEN MS1 18505 5 Paper roller EDAN MS1 19927 6 Thermal paper EDAN MS1 19917 7 Earth wire EDAN MS2 01952 8 Input output signal cable EDAN MS1 19907 9 Cable for electrodes with defibrillator protection EDAN MS1 20035 10 Electrode MSB1010 11 Carrying case EDAN SE 3 and accessories are available by contacting the manufacturer or your local distributor Manufac...

Page 69: ...pair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product is being repaired Service Policy All repairs on products must be performed or approved by EDAN Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall be exclusively be performed by EDAN certified service pe...

Page 70: ... to service claimer Out of warranty the service claimer is responsible for any freight insurance custom charges for product Contact information If you have any questions about maintenance technical specifications or malfunctions of devices please do not hesitate to contact us immediately Telephone 86 755 2689 9221 2689 9914 Fax 86 755 2689 8330 Email support edan com cn ...

Page 71: ... Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies The Electrocardiograph is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies building used for domestic purposes 11 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture ...

Page 72: ...UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment Power frequency 50Hz magnetic field IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 11 ...

Page 73: ...llular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Electrocardiograph is used exceeds the applicable RF complianc...

Page 74: ...ed at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These g...

Page 75: ...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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