EDAN SE-1 User Manual

Electrocardiograph

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EDAN Agile PLM Electronic Signature Information

--Signatures related to this document and performed in EDAN Agile PLM.

文件名称(Document Name)：SE-1说明书_英文

文件编号(Number)：01.54.019929

版本(Version)：1.6

产品型号(Product Model)：SE-1

项目编码(Project Code)：2080C000

签批信息(Signature):

作者(Originator) : 肖丽军 (xiaolijun)

审核人(Reviewers) : 董宁 (dongning)

审核人(Reviewers) : 肖玉华 (xiaoyuhua)

批准人(Approvers) : 王力维 (wangliwei)

批准人(Approvers) : 杨洁 (yangjie)

批准人(Approvers) : 陈浩杰 (chenhaojie)

2016-10-20 15:31:58

2016-10-20 15:53:43

2016-10-20 16:30:19

2016-10-24 10:36:04

2016-10-24 11:04:30

2016-10-24 09:21:25

Table of Contents

Summary of Contents for EDAN SE-1

Page 1 EDAN Agile PLM Electronic Signature Information --Signatures related to this document and performed in EDAN Agile PLM. 文件名称(Document Name)：SE-1说明书_英文文件编号(Number)：01.54.019929 版本(Version)：1.6 产品型号(Product Model)：SE-1 项目编码(Project 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...
Page 3 This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
Page 4 Terms Used in this Manual 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 5: Table Of Contents
2.4 Mains Connection and Switch ..................16 2.5 Bottom Panel ........................17 2.6 Function 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 .....................
Page 6 7.3 ECG Report ........................34 Chapter 8 Settings ........................35 8.1 Filter Settings ........................36 8.2 Recording Settings ......................36 8.3 Date and Time Settings ..................... 37 8.4 Print Head Test ........................37 8.5 External Input/Output Settings ..................38 8.6 Key Beep and QRS Beep Settings ..................38 8.7 Rhythm Lead Settings .......................
Page 7 Appendix 2 EMC Information ....................56 Appendix 3 Abbreviation ......................60...
Page 8: Chapter 1 Safety Guidance
SE-1 Electrocardiograph User Manual Safety Guidance Chapter 1 Safety Guidance This chapter provides important safety information related to the use of the single channel lectrocardiograph. 1.1 Indications for Use/Intended Use The intended use of the single channel lectrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes.
Page 9 SE-1 Electrocardiograph User Manual Safety Guidance WARNING 4. The results given by the equipment should be examined based on the overall clinical condition of the patient, and they can not substitute for regular checking. 5. This device is not intended for treatment.
Page 10 SE-1 Electrocardiograph User Manual Safety Guidance WARNING 20. Disposable electrodes must be used during defibrillation 21. 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).
Page 11 SE-1 Electrocardiograph User Manual Safety Guidance WARNING 27. Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it's specified as part of the system by manufacturer. And the multiple portable socket-outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system.
Page 12: Lithium Battery Care Warnings
SE-1 Electrocardiograph User Manual Safety Guidance 1.2.2 Lithium Battery Care Warnings WARNING 1. Improper operation may cause the lithium battery (hereinafter called battery) to be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It is necessary to read the user manual carefully and pay more attention to warning messages.
Page 13: General Cautions
SE-1 Electrocardiograph User Manual Safety Guidance 1.2.3 General Cautions CAUTION 1. Avoid liquid splash and excessive temperature. The temperature must be kept between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and 55 ºC during transportation and storage.
Page 14: Cleaning & Disinfection Cautions
SE-1 Electrocardiograph User Manual Safety Guidance CAUTION Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC/EN 60601-1: Limit: 50μA (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.
Page 15 SE-1 Electrocardiograph User Manual Safety Guidance DEFIBRILLATION-PROOF TYPE CF APPLIED PART Attention, consult ACCOMPANYING DOCUMENTS Operating instructions Equipotential grounding Alternating Current "ON" (power) "OFF" (power) Battery check Battery recharging indicator General symbol for recovery/recyclable Part Number SERIAL NUMBER Date of manufacture...
Page 16 SE-1 Electrocardiograph User Manual Safety Guidance MANUFACTURER AUTHORISED REPRESENTATIVE EUROPEAN COMMUNITY CE marking Disposal method Refer to User Manual (Background: Blue; Symbol: White) Warning (Background: Yellow; Symbol&Outline: Black) Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
Page 17: Chapter 2 Introduction
The auto and manual modes can be chosen freely. SE-1 can be powered by the mains supply or a built-in rechargeable lithium battery. Configuration: main unit and accessories, including patient cable, chest electrodes, limb electrodes, thermal recorder paper, power cord etc.
Page 18: Key Panel And Keys
SE-1 Electrocardiograph User Manual Introduction 2.2 Key Panel and Keys Indicator Mains supply indicator: when the device is powered by the mains supply, the indicator will be lit. Battery indicator: when the device is powered by a built-in rechargeable lithium battery, the indicator will be lit.
Page 19 SE-1 Electrocardiograph User Manual Introduction · 25 2.5mm/mV -10mV ~ +10mV · 5 5mm/mV -5mV ~ +5mV If the fluctuating range of the ECG signal is great, it’s better to choose AGC because the sensitivity can be adjusted automatically in this mode.
Page 20 SE-1 Electrocardiograph User Manual Introduction LEAD (Lead Switch Key) In the manual mode, press this key to switch the leads in order. PRINT/STOP Key Press this key to begin or stop printing ECG reports. ON/OFF Key After you connect the power cord to the outlet and press the mains switch, press this key to turn on or off the device.
Page 21: Patient Cable Socket And Signal Interface
SE-1 Electrocardiograph User Manual Introduction 12) AGE Press the AGE key to set the patient’s age group to CHILD, ADULT or OLD. 2.3 Patient Cable Socket and Signal Interface As Figure 2-1 shows, on the right side of the main unit are the patient cable socket, RS232 socket (reserved), external input/output socket and USB interface (reserved).
Page 22 SE-1 Electrocardiograph User Manual Introduction 2) RS232 Socket (Reserved) Definitions of corresponding pins: Signal Signal Signal RxD (input) TxD (output) 3) External Input/Output Socket Definitions of corresponding pins: Signal Signal ECG Signal (input) ECG Signal (output) 4) USB Interface (Reserved) WARNING 1.
Page 23: Mains Connection And Switch
SE-1 Electrocardiograph User Manual Introduction WARNING the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or your local distributor. 2. The summation of leakage current should never exceed leakage current limits while several other units are used at the same time.
Page 24: Bottom Panel
SE-1 Electrocardiograph User Manual Introduction 2.5 Bottom Panel Mains Supply Shift Switch Battery Compartment Fuse Fuse Label Label 1) Battery Compartment The battery label indicates the rated voltage and the rated capacity of the rechargeable lithium battery. Rated voltage: 14.8V, Rated capacity: 2500mAh.
Page 25: Function Features
SE-1 Electrocardiograph User Manual Introduction 3) Fuse There are two fuses of the same specifications installed on the bottom of the main unit. The specifications are shown on the fuse label: T400mAH250V, Ø5×20mm. WARNING Ruptured fuses must only be replaced with those of the same type and rating as the original.
Page 26: Chapter 3 About Se-1 Application Interface
Chapter 3 About SE-1 Application Interface The following sections provide an overview of the main functions in the SE-1 application. After you turn on the device, the main interface pops up. Then you can press the MENU key to open the system setup interface.
Page 27: About The System Setup Interface
SE-1 Electrocardiograph User Manual About SE-1 Application Interface Fourth Row: ♦ Sensitivity (×1, ×2, AGC, · 25, · 5) ♦ Paper speed (25, 50) ♦ Battery capacity symbol ( ，，， ♦ When you are setting the ID, sex or age group, the item will be shown here. The hint BATTERY WEAK will be shown here when the battery capacity is low.
Page 28: Chapter 4 Operation Preparations
SE-1 Electrocardiograph User Manual Operation Preparations Chapter 4 Operation Preparations CAUTION Before use, the equipment, patient cable and electrodes should be checked. Replace them if there is any evident defectiveness or aging which may impair the safety or the performance. Make sure that the equipment is in proper working condition.
Page 29: Loading/Replacing Recorder Paper
Operation Preparations Please refer to the maintenance section for how to recharge the battery. When the battery is being recharged, SE-1 can be powered by the mains supply at the same time. WARNING The potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical installation when necessary.
Page 30: Preparing The Patient
SE-1 Electrocardiograph User Manual Operation Preparations Place the paper and the roller gently in the recorder with the roller pin clicking into the groove; Pull about 2cm of paper out with the grid side of the paper facing the thermal print head, and shut the recorder casing with the paper edges in parallel with the scales on the surface of the casing;...
Page 31: Connecting The Patient Cable To The Electrocardiograph And Electrodes
SE-1 Electrocardiograph User Manual Operation Preparations Connecting Patient Cable Electrocardiograph and Electrodes WARNING The performance and electric shock protection can be guaranteed only if the original patient cable and electrodes of the manufacturer are used. The patient cable includes the main cable and the lead wires which can be connected to electrodes according to the colors and the identifiers.
Page 32: Attaching Electrodes To The Patient
SE-1 Electrocardiograph User Manual Operation Preparations 4.5 Attaching Electrodes to the Patient Chest Electrode: Suction Bulb Connecting to Lead Wire Metal Cup Limb Electrode: Connecting to Lead Wire Reed Clamp The identifiers and color codes of electrodes used comply with IEC/EN requirements. In order to avoid incorrect connections, the electrode identifiers and color codes are specified in Table 4-1.
Page 33 SE-1 Electrocardiograph User Manual Operation Preparations As the following figure shows, the positions of chest electrodes on the body surface are C1: Fourth intercostal space at the right border of the sternum C2: Fourth intercostal space at the left border of the sternum...
Page 34 SE-1 Electrocardiograph User Manual Operation Preparations Limb Electrode Connection: Ensure that the electrodes are clean; 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;...
Page 35: Inspection Before Power-On
SE-1 Electrocardiograph User Manual Operation Preparations 4.6 Inspection Before Power-On In order to avoid safety hazards and get good ECG records, the following inspection procedure is recommended before power-on and operation. 1) Environment: ♦ Make sure that there is no electromagnetic interference source around the equipment, especially large medical electrical equipment such as electrosurgical equipment, radiological equipment, magnetic resonance imaging equipment etc.
Page 36 SE-1 Electrocardiograph User Manual Operation Preparations 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. - 29 -...
Page 37: Chapter 5 Switching On The Electrocardiograph
( ) is lit. Then press the ON/OFF key 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.
Page 38: Chapter 6 Entering Patient Information
SE-1 Electrocardiograph User Manual Entering Patient Information Chapter 6 Entering Patient Information AUTO 1 10 : 50 І FLT = ALL × 1 25 E C G 2 5 6 MALE ADULT 1. Entering ID Number Press the ID key (the up or down arrow) to set the patient’s ID.
Page 39: Chapter 7 Printing Ecg Reports
SE-1 Electrocardiograph User Manual Printing ECG Reports Chapter 7 Printing ECG Reports There are four auto modes: AUTO 1, AUTO 2, AUTO 3 and AUTO 4. Two channels, including a rhythm lead, can be printed together in the AUTO 4 mode. The lead switch orders in different modes are listed in Table 2-1.
Page 40: Manual Mode
SE-1 Electrocardiograph User Manual Printing ECG Reports Pressing PRINT/STOP during the printing course can stop printing the ECG report. When you begin printing an ECG report later, the system will print the ECG report from the first lead, and the ID number will increase by one automatically. If the ID number needs to be unchanged, you should press the ID key to adjust it before printing the report.
Page 41: Ecg Report
SE-1 Electrocardiograph User Manual Printing ECG Reports 7.3 ECG Report Figure (a) AUTO1 Figure (b) AUTO4 As the above figures show, an ECG report includes the date and time, ID number, name (written by doctors later), sex, age, sensitivity, paper speed, filter settings, lead name, 1mV calibration mark, ECG wave and heart rate.
Page 42: Chapter 8 Settings
SE-1 Electrocardiograph User Manual Settings Chapter 8 Settings 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. The 19 menu items on the system setup interface are listed in Table 8-1. The double-underlined options are default settings.
Page 43: Filter Settings
SE-1 Electrocardiograph User Manual Settings Setting Method: FILTER SETTING : ALL PWAVE START : ON RECORD LENGTH RECORD COUNT : SECOND 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.
Page 44: Date And Time Settings
SE-1 Electrocardiograph User Manual Settings RECORD SPEED : 25 HEARTRATE PRINT : ON Take the above settings for example, the ECG will be printed from a P wave, the printing speed is 25mm/s, the printing length of each lead is 3 seconds, and the heart rate will be printed out on the bottom of the recorder paper.
Page 45: External Input/Output Settings
8.5 External Input/Output Settings The external input/output signal interface is equipped in the electrocardiograph, through which SE-1 can receive ECG signals from external equipment, and transmit ECG signals to external equipment. There are two options: ON and OFF. 8.6 Key Beep and QRS Beep Settings...
Page 46: Chapter 9 Switching Off The Electrocardiograph
SE-1 Electrocardiograph User Manual Switching Off the Electrocardiograph Chapter Switching 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.
Page 47: Chapter 10 Hint Information
SE-1 Electrocardiograph User Manual Hint Information Chapter 10 Hint Information Hint information will be displayed on the LCD screen when there is something wrong. Hint information provided by the electrocardiograph and the corresponding causes are listed in Table 10-1. Table 10-1 Hint Information and Causes...
Page 48: Chapter 11 Cleaning, Care And Maintenance
SE-1 Electrocardiograph User Manual Cleaning, Care and Maintenance Chapter 11 Cleaning, Care and Maintenance Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods.
Page 49: Cleaning The Main Unit
SE-1 Electrocardiograph User Manual Cleaning, Care and Maintenance Mild near neutral detergent Ethanol (75%) Isopropanol (70%) Cleaning agents should be applied or removed using a clean, soft, non-abrasive cloth or paper towel. 11.2.1 Cleaning the Main Unit WARNING Turn off the power before cleaning. The mains supply must be switched off if it is used.
Page 50: Disinfection
SE-1 Electrocardiograph User Manual Cleaning, Care and Maintenance dampened with the cleaning solution until no visible contaminants remain. 3. Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible cleaning agent remains.
Page 51: Disinfecting The Patient Cable
SE-1 Electrocardiograph User Manual Cleaning, Care and Maintenance 11.3.2 Disinfecting the Patient Cable 1. Wipe the patient cable with a soft cloth dampened with the disinfectant solution. 2. Wipe off the disinfectant solution with a dry cloth after disinfection. 3. Leave the patient cable to air dry for at least 30 minutes.
Page 52: Recorder Paper
( ) is black. When SE-1 is turned off, the battery recharging indicator lamp ( ) is still lit because the equipment can not monitor the recharge status, so you need to turn on the device to verify the recharge status.
Page 53: Maintenance Of Main Unit, Patient Cable And Electrodes
SE-1 Electrocardiograph User Manual Cleaning, Care and Maintenance trans-print each other. Note: Recorder paper provided by the manufacturer should be used. Other paper may shorten the life of the thermal print head. The deteriorated print head may lead to illegible ECG reports and block the advance of the paper.
Page 54 SE-1 Electrocardiograph User Manual Cleaning, Care and Maintenance The leakage current should never exceed the limit. 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.
Page 55 SE-1 Electrocardiograph User Manual Cleaning, Care and Maintenance 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.
Page 56: Chapter 12 Accessories And Ordering Information
SE-1 Electrocardiograph User Manual Accessories and Ordering Information Chapter Accessories Ordering Information WARNING Only the patient cable and other accessories supplied by the manufacturer can be used. Or else, the performance and electric shock protection can not be guaranteed. Table 12-1 Standard Accessory List...
Page 57 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 distributor. NOTE: The part name may vary depending on context, but the part number is constant. - 50 -...
Page 58: Chapter 13 Warranty And Service
EDAN will, at its discretion, repair 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.
Page 59: Appendix 1 Technical Specifications
SE-1 Electrocardiograph User Manual Technical Specifications Appendix 1 Technical Specifications A1.1 Safety Specifications IEC 60601-1:2005/A1:2012 EN 60601-1:2006/A1:2013 Standards: IEC 60601-1-2:2007 EN 60601-1-2:2007/AC:2010 IEC 60601-2-25:2011 Anti-electric-shock type: Class І with internal power supply Anti-electric-shock degree: Type CF Degree of protection against...
Page 60: A1.2 Environment Specifications
SE-1 Electrocardiograph User Manual Technical Specifications A1.2 Environment Specifications Transport & Storage Working Temperature: -20ºC (-4ºF) ~ +55ºC (+131ºF) +5ºC (+41ºF) ~ +40ºC (+104ºF) 25%RH~93%RH 25%RH~80%RH Relative Humidity: Non-Condensing Non-Condensing Atmospheric Pressure: 70 kPa ~106 kPa 86 kPa ~106 kPa A1.3 Physical Specifications...
Page 61: A1.5 Performance Specifications
SE-1 Electrocardiograph User Manual Technical Specifications Power Consumption: 35VA T400mAH250V, Ø5×20mm. Fuse: A1.5 Performance Specifications Recording Recorder: Thermal dot-matrix recorder 8 dots per mm / 200 dots per inch (amplitude axes) Printing Density 40 dots per mm / 1000 dots per inch (time axes, @ 25 mm/s) Rolled thermal paper: 50mm×30m...
Page 62 SE-1 Electrocardiograph User Manual Technical Specifications Calibration Voltage: 1mV±3% ±300mV DC Offset Voltage: 20 μVp-p Minimum Amplitude: ≤12.5µVp-p Noise: EMG Filter: 35Hz (-3dB) Filter AC/DFT Filter: 50Hz/60Hz (-20dB) CMRR ≥110dB Sampling Frequency 1000 Hz External Input/Output (Optional) ≥100kΩ; Sensitivity 10mm/V±5%;...
Page 63 Guidance and manufacture’s declaration – electromagnetic emission The SE-1 Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the SE-1 Electrocardiograph should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment –...
Page 64 SE-1 Electrocardiograph User Manual EMC Information ±1 kV line to ±1 kV line to line Surge Mains power quality should be ±2 kV line to IEC 61000-4-5 line that of a typical commercial or ±2 kV line to ground hospital environment.
Page 65 SE-1 Electrocardiograph User Manual EMC Information Guidance and manufacture’s declaration – electromagnetic immunity – For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity The Electrocardiograph is intended for use in the electromagnetic environment specified below.
Page 66 SE-1 Electrocardiograph User Manual EMC Information 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.
Page 67 SE-1 Electrocardiograph User Manual Abbreviation Appendix 3 Abbreviation Abbr English Electrocardiogram/Electrocardiograph Heart Rate Left Foot Augmented Lead Left Arm Augmented Lead Right Arm Augmented Lead Left Arm Left Leg Right Arm Right Leg Identification Alternating Current Universal Serial Bus Auto Gain Control...

EDAN SE-1 User Manual

Chapter 1 Safety Guidance

Chapter 2 Introduction

Chapter 3 About SE-1 Application Interface

Chapter 4 Operation Preparations

Chapter 5 Switching on the Electrocardiograph

Chapter 6 Entering Patient Information

Chapter 7 Printing ECG Reports

Chapter 8 Settings

Chapter 9 Switching off the Electrocardiograph

Chapter 10 Hint Information

Chapter 11 Cleaning, Care and Maintenance

Chapter 12 Accessories and Ordering Information

Chapter 13 Warranty and Service

Appendix 1 Technical Specifications

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