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Appendix 2 EMC Information .................................................................................................... 56

Appendix 3 Abbreviation ............................................................................................................. 60

Содержание SE-1

Страница 1: ...roject Code 2080C000 签批信息 Signature 作者 Originator 肖丽军 xiaolijun 2016 10 20 15 31 58 审核人 Reviewers 董宁 dongning 2016 10 20 15 53 43 审核人 Reviewers 肖玉华 xiaoyuhua 2016 10 20 16 30 19 批准人 Approvers 王力维 wangliwei 2016 10 24 10 36 04 批准人 Approvers 杨洁 yangjie 2016 10 24 11 04 30 批准人 Approvers 陈浩杰 chenhaojie 2016 10 24 09 21 25 版权深圳市理邦精密仪器股份有限公司 Copyright Edan Instrument Inc 理邦保密文件 E D A N C O N...

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Страница 3: ...ected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN ED...

Страница 4: ... 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 5: ...unction Features 18 Chapter 3 About SE 1 Application Interface 19 3 1 About the Main Interface 19 3 2 About the System Setup Interface 20 Chapter 4 Operation Preparations 21 4 1 Power and Earthling 21 4 2 Loading Replacing Recorder Paper 22 4 3 Preparing the Patient 23 4 3 1 Instructing the Patient 23 4 3 2 Preparing the Skin 23 4 4 Connecting the Patient Cable to the Electrocardiograph and Electr...

Страница 6: ... 2 3 Cleaning the Reusable Electrodes 42 11 3 Disinfection 43 11 3 1 Disinfecting the Main Unit 43 11 3 2 Disinfecting the Patient Cable 44 11 3 3 Disinfecting the Reusable Electrodes 44 11 4 Care and Maintenance 44 11 4 1 Recharge and Replacement of Battery 44 11 4 2 Recorder Paper 45 11 4 3 Maintenance of Main Unit Patient Cable and Electrodes 46 Chapter 12 Accessories and Ordering Information 4...

Страница 7: ...V Appendix 2 EMC Information 56 Appendix 3 Abbreviation 60 ...

Страница 8: ...raph safely and effectively and avoid possible dangers caused by improper operation please read through the user manual and be sure to be familiar with all functions of the equipment and proper operation procedures before use Please pay more attention to the following warning and caution information Note 1 This device is not intended for home use 2 The pictures and interfaces in this manual are fo...

Страница 9: ...tient cable and other accessories not supplied by the manufacturer may result in increased emissions or decreased immunity of the equipment 13 Make sure that all electrodes are connected to the patient correctly before operation 14 Ensure that the conductive parts of electrodes and associated connectors including neutral electrodes do not come in contact with earth or any other conducting objects ...

Страница 10: ...provide a Within the patient environment a level of safety comparable to that provided by medical electrical equipment complying with IEC EN 60601 1 and b Outside the patient environment the level of safety appropriate for non medical electrical equipment complying with other IEC or ISO safety standards 23 All the accessories connected to system must be installed outside the patient vicinity if th...

Страница 11: ...alfunctions caused by electrosurgery according to the clause 36 202 101 in the standard IEC 60601 2 25 31 The electrocardiograph shall not be serviced or maintained while in use with a patient 32 The appliance coupler or mains plug is used as isolation means from supply mains Position the electrocardiograph in a location where the operator can easily access the disconnection device 33 The medical ...

Страница 12: ...ater at once If the leakage liquid splashes into your eyes do not wipe them Irrigate them with clean water first and go to see a doctor immediately 6 The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal Batteries are hazardous waste Do NOT dispos...

Страница 13: ...efectiveness or aging symptom which may impair the safety or the 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 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...

Страница 14: ...inal 1 2 4 Cleaning Disinfection Cautions CAUTION 1 Turn off the power before cleaning and disinfection If the mains supply is used the power cord should be dragged out of the outlet Prevent the detergent from seeping into the equipment 2 Do not immerse the unit or the patient cable into liquid under any circumstances 3 Do not clean the unit and accessories with abrasive fabric and avoid scratchin...

Страница 15: ...ED PART 4 Attention consult ACCOMPANYING DOCUMENTS 5 Operating instructions 6 Equipotential grounding 7 Alternating Current 8 ON power 9 OFF power 10 Battery check 11 Battery recharging indicator 12 General symbol for recovery recyclable 13 Part Number 14 SERIAL NUMBER 15 Date of manufacture ...

Страница 16: ...N THE EUROPEAN COMMUNITY 18 CE marking 19 Disposal method 20 Refer to User Manual Background Blue Symbol White 21 Warning Background Yellow Symbol Outline Black 22 Caution Federal U S law restricts this device to sale by or on the order of a physician NOTE The user manual is printed in black and white ...

Страница 17: ...ium battery Configuration main unit and accessories including patient cable chest electrodes limb electrodes thermal recorder paper power cord etc WARNING 1 This equipment is intended for use on adult and pediatric patients only 2 This equipment is not designed for direct cardiac application 3 The results given by the equipment should be examined based on the overall clinical condition of the pati...

Страница 18: ...d to the outlet and press the mains switch both the battery recharging indicator and the mains supply indicator will be lit Note When the device is powered off the recharging indicator is still lit after t he battery is fully charged 2 SENS Sensitivity Switch Key The sensitivity switch order 1 2 AGC 25 5 The measurable and recordable ECG signal range varies with the sensitivity as the following li...

Страница 19: ... 1 second So in the case of baseline drift press this key to draw the baseline to zero quickly and the ECG wave resumes after 1 second 4 1mV Calibration Key In the manual mode press this key to print a 1mV calibration mark during the printing course 5 MODE Mode Switch Key Press this key to select a working mode among four auto modes and a manual mode The switch order of leads in each mode is liste...

Страница 20: ...ey After you connect the power cord to the outlet and press the mains switch press this key to turn on or off the device 9 MENU Key Press this key to open the system setup interface 10 ID Setting Key Press these two keys to set the patient ID Press the up arrow key to increase the ID number and press the down arrow key to decrease the ID number 11 M F Press the M F key to set the sex of the patien...

Страница 21: ...S232 socket reserved external input output socket and USB interface reserved 1 Patient Cable Socket DEFIBRILLATION PROOF TYPE CF APPLIED PART Attention consult ACCOMPANYING DOCUMENTS Definitions of corresponding pins Pin Signal Pin Signal Pin Signal 1 C2 V2 6 SH 11 F LL 2 C3 V3 7 NC 12 C1 V1 or NC 3 C4 V4 8 NC 13 C1 V1 4 C5 V5 9 R RA 14 RF N RL or NC 5 C6 V6 10 L LA 15 RF N RL Note The left side o...

Страница 22: ...ignal output 4 USB Interface Reserved WARNING 1 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configuration shall comply with the valid version of the standard IEC EN 60601 1 1 Therefore anybody who connects addi...

Страница 23: ... used at the same time 2 4 Mains Connection and Switch As the above figure shows on the left side of the main unit are the mains socket mains switch and potential equalization conductor 1 Potential Equalization Conductor The potential equalization conductor provides a connection between the unit and the potential equalization bus bar of the electrical installation 2 Mains Socket AC SOURCE alternat...

Страница 24: ...an open the battery compartment and replace the battery The battery of the same model and specification provided by the manufacturer must be used 2 Mains Supply Shift Switch The mains supply with the rated input voltage of 230V 220V 240V or 115V 100V 115V can be chosen by using the shift switch according to local mains supply specifications WARNING Only qualified installation or service engineers ...

Страница 25: ...nd compact size Well designed membrane key panel for easy operation LCD screen for single channel ECG view Four auto modes and a manual mode are optional General menu for setting parameters Built in rechargeable lithium battery with large capacity Hint information of lead off lack of paper low battery capacity etc Thermal dot matrix recorder for high resolution printout Automatic adjustment of bas...

Страница 26: ...About the Main Interface Figure 3 1 Main Interface The LCD screen can be revolved and settled freely at different angles Normally the contents displayed on the LCD screen include described from left to right in row order First Row Working mode AUTO1 AUTO2 AUTO3 AUTO4 and MANU II stop symbol which will turn to during the printing course Hint information LDOFF PAPER etc Current time Second Row Curre...

Страница 27: ...p Interface When the main interface is displayed press the MENU key to open the system setup interface Press the MENU key again to return to the main interface Figure 3 2 System Setup Interface 1 Press the ID key the up or down arrow to move the arrow on the right of the LCD screen to the item to be changed 2 Then press the M F or AGE key to select an option for the item 3 After setting the items ...

Страница 28: ...t If the mains supply is used connect the power cord to the socket first and then connect the power cord to the hospital grade outlet Operating voltage 100V 115V 220V 240V Operating frequency 50Hz 60Hz Input power 35VA Make sure that the mains supply meets the above requirements before power on and then press the mains switch Then the mains supply indicator will be lit as well as the battery recha...

Страница 29: ...r Paper The rolled thermal paper with the width of 50mm is used When the recorder paper runs out or is not loaded the hint PAPER will appear on the screen Then you should load or replace the recorder paper immediately Loading Replacing Process 1 Place fingers under the two flanges of the recorder casing pull them upwards directly to release the casing 2 Take out the paper roller and remove remaind...

Страница 30: ... patient in a quiet room or area where others can t see the patient Make sure that the patient is comfortable The more relaxed the patient is the less the ECG will be affected by noise 4 3 2 Preparing the Skin Thorough skin preparation is very important The skin is a poor conductor of electricity and frequently creates artifact that distorts the ECG signals By performing methodical skin preparatio...

Страница 31: ...Connecting the Patient Cable to the Electrocardiograph Connect the patient cable to the patient cable socket on the right side of the main unit and then secure them with two screws 2 Connecting the Patient Cable to Electrodes Align all lead wires of the patient cable to avoid twisting and connect the lead wires to the electrodes Firmly attach them WARNING This product is CF classified and defibril...

Страница 32: ...uirements are given in Table 4 1 too Table 4 1 Electrodes Identifiers and Color Codes European American Electrodes Identifiers Color Codes Identifiers Color Codes 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 White red V1 Brown red Chest 2 C2 White yellow V2 Brown yellow Chest 3 C3 White green V3 Brown green Chest 4 C4 White...

Страница 33: ... electrode In order to get a high quality ECG the skin electrode resistance must be minimized when you attach electrodes to patients Chest Electrode Connection 1 Ensure that the electrodes are clean 2 Align all lead wires of the patient cable to avoid twisting and connect the lead wires to the corresponding electrodes according to the colors and the identifiers 3 Clean the electrode area on the ch...

Страница 34: ...area above the ankle or the wrist 7 Attach all limb electrodes in the same way WARNING 1 Make sure that all electrodes are connected to the patient correctly before operation 2 Make sure that the conductive parts of electrodes and associated connectors including neutral electrodes do not come in contact with earth or any other conducting objects 3 Electrodes with defibrillator protection should be...

Страница 35: ... is used please check whether the power cord is connected to the unit well The grounded three slot outlet should be used When the battery capacity is low recharge the battery before use 3 Patient Cable Make sure that the patient cable is connected to the unit firmly and keep it far away from the power cord 4 Electrodes Make sure that all electrodes are connected to lead wires of the patient cable ...

Страница 36: ... Manual Operation Preparations 29 WARNING The electrocardiograph is intended to be used by qualified physicians or personnel professionally trained and they should be familiar with the contents of this user manual before operation ...

Страница 37: ...ey on the key panel to turn on the unit The equipment information such as the device name the version number will be displayed on the LCD screen after self test Then SE 1 is ready for use When a built in rechargeable lithium battery is used press the ON OFF key on the key panel directly to turn on the unit and then the battery indicator is lit The equipment information such as the device name the ...

Страница 38: ...INT STOP to print a new report the ID number will increase by one automatically 2 Entering the Patient s Sex Press the M F key to set the sex of the patient which will be displayed for one or two seconds in the last row on the LCD screen such as MALE in the above figure 3 Entering the Patient s Age Group Patients are divided into three age groups CHILD ADULT OLD Press the AGE key to set the age gr...

Страница 39: ...aper before printing the ECG wave of next lead in the AUTO4 mode In the manual mode you can determine the lead to be printed and print the ECG wave of the selected lead continually 7 1 Auto Mode Operation Procedures 1 Press the MODE key to select an auto mode which will be displayed in the top left corner of the LCD screen 2 If AUTO4 is selected you can select a rhythm lead on the system setup int...

Страница 40: ...course in the auto mode 7 2 Manual Mode Operation Procedures 1 Press the MODE key to select the MANU mode which will be displayed in the top left corner of the LCD screen 2 Press the Lead switch key to select the lead to be printed 3 Press the SENS key to select an appropriate sensitivity For details about the signal ranges of different sensitivities please refer to Section 2 2 Key Panel and Keys ...

Страница 41: ...name written by doctors later sex age sensitivity paper speed filter settings lead name 1mV calibration mark ECG wave and heart rate The lead name and a 1mV calibration mark are printed before the ECG wave of each lead On the top of the ECG wave of each lead the sensitivity is printed The sensitivity of each lead may be different because it can be changed during the printing course ...

Страница 42: ...re default settings Table 8 1 Menu Items No Menu Items Options 1 FILTER SETTING AC ALL OFF EMG 2 PWAVE START ON OFF 3 RECORD LENGTH 2 3 4 11 12 4 RECORD COUNT SECOND QRS 5 RECORD SPEED 25 50 unit mm s 6 HEARTRATE PRINT ON OFF 7 YEAR 0 99 8 MONTH 1 12 9 DAY 1 31 10 HOUR 0 23 11 MINUTE 0 59 12 PRINT HEAD TEST ON OFF 13 DEFAULT SETTING OFF RESTORE 14 EXTINPUT RECORD ON OFF 15 KEY BEEP ON OFF 16 QRS B...

Страница 43: ...gs except the date time and language The following sections provide an introduction to the menu items 8 1 Filter Settings You can set FILTER SETTING to EMG AC ALL both EMG and AC or OFF no filter When it is set to OFF the filters will not work Generally it is recommended to be set to ALL to get a better ECG record Note To pass the distortion test the electrocardiograph has to be configured with th...

Страница 44: ...ontinue until it reaches 2 seconds 8 3 Date and Time Settings YEAR 4 MONTH 8 DAY 6 HOUR 14 MINUTE 25 As the above settings show the date and the time is set to Aug 6th 2004 14 25 PM The time will be displayed on the LCD screen The date and the time will be printed in the ECG report Note Please set DATE TIME correctly when it s the first time you use the electrocardiograph 8 4 Print Head Test PRINT...

Страница 45: ...quipment There are two options ON and OFF 8 6 Key Beep and QRS Beep Settings KEY BEEP ON QRS BEEP OFF When KEY BEEP is set to ON there is a short beep when the keys on the key panel are pressed When QRS BEEP is set to ON there is a short beep when an R wave is detected 8 7 Rhythm Lead Settings RHYTHM LEAD П In the AUTO4 mode ECG waves of a lead and a rhythm lead can be printed The rhythm lead can ...

Страница 46: ...Chapter 9 Switching Off the Electrocardiograph When the built in battery is used press the ON OFF key directly to turn off the unit When the mains supply is used press the ON OFF key and then press the mains switch on the left side of the unit Pull out the plug from the outlet ...

Страница 47: ...onding causes are listed in Table 10 1 Table 10 1 Hint Information and Causes Hint Information Causes LDOFF Electrodes fall off the patient or the patient cable falls off the unit PAPER Recorder paper runs out or is not loaded BATTERY WEAK The battery capacity is low The heart rate is over 300BPM or below 30BPM or the heart rate has not been detected in 2 seconds OVR The ECG signal exceeds the mea...

Страница 48: ...leaning agents and disinfectants listed in this manual Others may cause damage not covered by warranty reduce product lifetime or cause safety hazards Always dilute according to the manufacturer s instructions Unless otherwise specified do not immerse any part of the equipment or any accessories in liquid Do not pour liquid onto the equipment Do not allow liquid to enter the case Never use abrasiv...

Страница 49: ...ened with tap water after cleaning until no visible cleaning agent remains 4 Dry the main unit in a ventilated and cool place 11 2 2 Cleaning the Patient Cable 1 Wipe the patient cable with a soft cloth dampened with the cleaning solution until no visible contaminants remain 2 Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible cleanin...

Страница 50: ...trocardiograph and reusable accessories are Ethanol 75 Isopropanol 70 If Ethanol or Isopropanol is used for both cleaning and disinfecting then a new cloth is required to be used for the disinfection step CAUTION 1 Do not use high temperature high pressure vapour or ionizing radiation as disinfection methods 2 Do not use chloric disinfectant such as chloride sodium hypochlorite etc 3 Clean and dis...

Страница 51: ...1 4 1 Recharge and Replacement of Battery 1 Capacity Identification The current capacity of the rechargeable battery can be identified according to the battery symbol in the last row on the LCD screen Capacity is full Capacity is not full but enough Capacity is limited and recharge should be taken into account Capacity is low and the hint BATTERY WEAK will be displayed on the LCD screen The batter...

Страница 52: ... open the battery compartment and replace the battery The battery of the same model and specification provided by the manufacturer must be used 2 Danger of explosion Do not reverse the anode and the cathode when installing the battery 3 Remove the battery from the electrocardiograph when the electrocardiograph is not used for a long time 4 If the battery is stored alone and not used for a long tim...

Страница 53: ... compliance with the rated current and circuit breaking characteristics d Verify that the device functions properly as described in the instructions for use e Test the protection earth resistance according to IEC EN 60601 1 Limit 0 1 ohm f Test the earth leakage current according to IEC EN 60601 1 Limit NC 500μA SFC 1000μA g Test the enclosure leakage current according to IEC EN 60601 1 Limit NC 1...

Страница 54: ...trocardiograph can not be guaranteed 2 Patient Cable Integrity of the patient cable including the main cable and lead wires should be checked regularly Make sure that it is conductible Do not drag or twist the patient cable with excessive stress while using it Hold the connector plug instead of the cable when connecting or disconnecting the patient cable Align the patient cable to avoid twisting k...

Страница 55: ...ing Care and Maintenance 48 CAUTION The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal ...

Страница 56: ...art Number Power Cord 01 13 036638 Patient Cable European 01 57 471016 01 57 471500 Patient Cable American 01 57 471017 01 57 471499 Adult Chest Electrodes 01 57 040163 Adult Limb Electrodes 01 57 040162 Paper roller 01 51 19992 Thermal Recorder paper Roll 50mm 30m 01 57 19917 Fuse 21 21 064183 Rechargeable Li ion Battery 21 21 064149 Table 12 2 Optional Accessory List Accessory Part Number Patien...

Страница 57: ...172 Alligator Clip Banana Socket Adapters 01 57 040173 Adult Disposable Adhesive Electrodes 01 57 471056 Pediatric Disposable Adhesive Electrodes 01 57 471057 Disposable Resting electrodes 01 57 471031 Grounding Wire 01 13 114114 ECG Bag 01 56 465628 MT 201 Trolley 83 61 111847 CA 100 Lead wire bracket 02 04 111902 SE 1 and accessories are available by contacting the manufacturer or your local dis...

Страница 58: ... damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty is determined to be defective because of defective materials components or workmanship and the warranty claim is made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute pr...

Страница 59: ...Type CF Degree of protection against harmful ingress of water Ordinary equipment Sealed equipment without liquid proof Disinfection sterilization method Refer to the user manual for 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 EMC CISPR 11 Group 1 Class A Patient Leakage Cu...

Страница 60: ...tery Display 192 64 dot single color LCD screen A1 4 Power Supply Specifications Mains Supply Operating Voltage 100V 115V 220V 240V Operating Frequency 50Hz 60Hz Input Power 35VA Built in Lithium Battery Pack Rated voltage 14 8V Rated capacity 2500mAh When the battery is fully charged the electrocardiograph can work normally for nearly 6 5 hours and it can continually print for about 4 hours in th...

Страница 61: ...ime axes 25 mm s Recorder Paper Rolled thermal paper 50mm 30m Effective Width 48 mm Paper Speed 25mm s 50mm s Accuracy of data 3 HR Recognition Technique Peak peak detection HR Range 30 BPM 300 BPM Accuracy 1 BPM ECG Unit Leads 12 standard leads Acquisition Mode One lead A D 12 bits Resolution 2 52uV LSB Time Constant 3 2s Frequency Response 0 05Hz 150Hz 3dB Sensitivity 2 5mm mV 5mm mV 10mm mV 20 ...

Страница 62: ...e 20 μVp p Noise 12 5µVp p Filter EMG Filter 35Hz 3dB AC DFT Filter 50Hz 60Hz 20dB CMRR 110dB Sampling Frequency 1000 Hz External Input Output Optional Input 100kΩ Sensitivity 10mm V 5 Single ended Output 100Ω Sensitivity 1V mV 5 Single ended Note Operation of the equipment below the minimum amplitude may cause inaccurate results ...

Страница 63: ...ected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacture s declaration electromagnetic immunity For all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The Electrocardiograph is intended ...

Страница 64: ...T 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in 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 60Hz magnetic field IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should...

Страница 65: ...e transmitter Recommended separation distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms P d 2 1 Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m P d 2 1 80 MHz to 800 MHz P d 3 2 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field ...

Страница 66: ...s intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the electrocardiograph as recommended below according to the maximum output power of the commu...

Страница 67: ...glish ECG Electrocardiogram Electrocardiograph HR Heart Rate aVF Left Foot Augmented Lead aVL Left Arm Augmented Lead aVR Right Arm Augmented Lead LA Left Arm LL Left Leg RA Right Arm RL Right Leg ID Identification AC Alternating Current USB Universal Serial Bus AGC Auto Gain Control ...

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