EDAN iSe Series User Manual
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EDAN iSe Series User Manual

Electrocardiograph
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  • Page 2 User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages.
  • Page 3 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. NOTE A NOTE provides useful information regarding a function or a procedure.

  • Page 4: Table Of Contents

    Table of Contents Chapter 1 Introduction....................1 1.1 Product Information....................1 1.1.1 Product Overview ..................1 1.1.2 Indications for Use/Intended Use..............1 1.1.3 Features & Benefits ..................2 1.1.4 Controls, Indicators, and Connectors............2 1.1.5 Software Overview..................6 1.1.6 ECG Cable and Lead Wires ..............12 1.1.7 Symbols....................13 1.2 Safety Information....................16 1.2.1 General Warnings..................16 1.2.2 Protecting Personal Information..............19...
  • Page 5 5.4 Pharmaceutical Study ..................38 5.5 VCG and SAECG....................38 5.6 HRV ........................38 Chapter 6 Editing ECGs....................39 6.1 ECG View ......................39 6.2 ECG Measurement/Diagnosis................40 6.3 Editing Measurements/Diagnosis...............41 6.4 Retrieving Diagnosis..................42 6.5 Reviewing Electronic Medical Record..............42 6.6 Comparing ECGs....................43 Chapter 7 Printing an ECG Report................44 Chapter 8 Transmitting and Exporting ECGs ............45 Chapter 9 Deleting ECGs.....................46 Chapter 10 System Setting..................47...
  • Page 6 A1.2 Environment Specifications ................68 A1.3 Physical Specifications ..................69 A1.4 Power Supply Specifications ................69 A1.5 Performance Specifications................69 Appendix 2 EMC Information ..................72 Appendix 3 Abbreviation.....................80...

  • Page 7: Chapter 1 Introduction

    NOTE: All illustrations in this manual are provided as examples only. 1.1.2 Indications for Use/Intended Use The iSE series electrocardiograph is intended 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.

  • Page 8: Features & Benefits

    Small (1.2 kg±0.3 kg minimum), at least 8 hours of continuous usage on Li-ion battery Use the electrocardiograph in a wide variety of care environments. Easy communication and synchronization with EDAN’s SE-1515 PC ECG Communicate with the server via WIFI or mobile network. Large storage capacity Minimum of 16 GB local memory, allows you to extend the device’s storage capacity by...
  • Page 9 Series Electrocardiograph User Manual Introduction Camera Reserved. Indicates power usage in different colors: Blue: the electrocardiograph is powered by battery. Green: the electrocardiograph is connected to AC power. Or when the electrocardiograph is connected Power light to both the battery and AC power, the battery is full.
  • Page 10 Series Electrocardiograph User Manual Introduction 3 4 5 6 Name Description Pull down the switch to open the paper tray. To close the tray, close the door directly. Paper tray switch NOTE: This is only applicable to electrocardiographs with thermal printer.
  • Page 11 Series Electrocardiograph User Manual Introduction Name Description Paper tray (option) Contains thermal chart paper roll. Handle (option) Figure 5 Right Name Description ECG cable socket Connects to the ECG cable. DE18 socket Connects to the DE18 connection cable. Identifies...

  • Page 12: Software Overview

    Series Electrocardiograph User Manual Introduction Press and hold the button. A menu pops up, providing the following options: restart, power off, and screenshot. To enable power-save, gently press the button. Figure 6 Bottom Name Description Contains a battery to supply power when the unit is Battery not connected to AC power.
  • Page 13 Series Electrocardiograph User Manual Introduction Submenu Description Displays patients that have ordered an ECG test Patient and contains a number of operations you can perform on patient information. Stores ECGs that have been recorded and ECG File contains a number of operations you can perform on ECGs.
  • Page 14 Series Electrocardiograph User Manual Introduction Room No. Name Outp./Inp./PE ID ECG Test Department Button/Icon Description Main Menu Return to the Display the on-screen number of patients to be tested. This number updates in real time. This icon provides the following options: sequence setting, filtering setting, download setting, and order server.
  • Page 15 Series Electrocardiograph User Manual Introduction Activate iSE’s infrared scanner to scan the barcode so as to retrieve the Outpatient / Inpatient / PE ID. Tap this icon again to stop scanning. Download the specific patient information from the PC. You need to enter the default key word for order querying so that the information with the order can be downloaded.
  • Page 16 Series Electrocardiograph User Manual Introduction Start or stop ECG recording. NOTE: iSE can record up to 1,800-second ECGs. Re-acquire ECGs. Auto Recording mode, including Auto and Manual. Tap on it to toggle between the two modes. In the Auto mode, the system will acquire ECGs at the set time and then print a report.
  • Page 17 Series Electrocardiograph User Manual Introduction Button/Icon Description Search for ECGs that have been recorded. Enter the key word for search and the system will display the ECGs that meet the criteria. Fuzzy search is supported. Filter ECGs. You can filter ECGs by using the criteria such as uploaded or not, diagnosed or not, printed or not, and the exam time.

  • Page 18: Ecg Cable And Lead Wires

    Series Electrocardiograph User Manual Introduction Modify the patient information of an ECG file. You can modify all patient information except ID and exam item. Press and hold an ECG file. This button will appear. Edit NOTE: If patient information such as names or gender are modified, the information elsewhere with the same ID number will be updated.

  • Page 19: Symbols

    Series Electrocardiograph User Manual Introduction Connect to electrocardiograph Connect to electrodes ECG cable Lead wires Figure 12 DE18 sampling box, DE18 cable, and lead wires Connect to electrocardiograph Connect to DE18 sampling DE18 cable DE18 sampling box, Electrode connector Cable connector 1.1.7 Symbols...
  • Page 20 Series Electrocardiograph User Manual Introduction Consult operating instructions Near-field communication USB interface SIM and SD cards slot (two-in-one) Computer network On/Off switch General symbol for recovery/recyclable Part Number SERIAL NUMBER Date of manufacture MANUFACTURER AUTHORISED REPRESENTATIVE EUROPEAN COMMUNITY CE marking...
  • Page 21 Series Electrocardiograph User Manual Introduction Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Refer to instruction manual/booklet (Background: Blue; Symbol: White) General warning sign (Background: Yellow; Symbol & Outline: Black)

  • Page 22: Safety Information

    Series Electrocardiograph User Manual Introduction 2. The right angle bracket “>” is a concise method to indicate a sequence of menu selections. 3. *: Apply to devices with wireless functions. 1.2 Safety Information This section provides important safety information related to the use of iSE.
  • Page 23 Series Electrocardiograph User Manual Introduction 9. The disposable electrodes can only be used for one time. 10. Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator. 11. Do not touch accessible parts of electrical equipment and the patient simultaneously.
  • Page 24 X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. 30. The electrocardiograph should be placed on a flat surface or EDAN’s trolley. Avoid it dropping down to cause strong shock.

  • Page 25: Protecting Personal Information

    EDAN recommends health care organizations or medical institutions to implement a comprehensive and multifaceted strategy to protect the information and systems from internal and external security threats.
  • Page 26 2. Ensure that all device components maintaining personal information (other than removable media) are physically secure (i.e. cannot remove without tools). 3. Ensure that the electrocardiograph is connected only to the device authorized/approved by EDAN. Users should operate all EDAN deployed and supported electrocardiographs...

  • Page 27: Battery Care Warnings

    18. The operating system of iSE can only be upgraded by the manufacturer or its authorized personnel. If the user reinstall iSE with other operating system not authorized by EDAN, the resulting security risks and losses shall be borne by the user. Possible security risks are user information stolen, sending SMS automatically, locating your location.

  • Page 28: General Cautions

    Series Electrocardiograph User Manual Introduction installing the battery. 4. Do not heat or splash the battery or throw it into fire or water. 5. Do not destroy the battery; do not pierce battery with a sharp object such as a needle;...
  • Page 29 Series Electrocardiograph User Manual Introduction recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product. 5. Federal (U.S.) law restricts this device to sale by or on the order of a physician.

  • Page 30: Chapter 2 Setting Up The Electrocardiograph

    Series Electrocardiograph User Manual Setting Up the Electrocardiograph Chapter 2 Setting Up the Electrocardiograph WARNING The equipment, patient cable and electrodes should be checked before use. Replace them if there is any evident defectiveness or aging that may impair the safety or the performance, and make sure that the equipment is in proper working condition.

  • Page 31: Connecting The Ecg Cable

    Series Electrocardiograph User Manual Setting Up the Electrocardiograph The patient should not come into contact with conducting objects such as earth, metal parts etc. Ensure that the patient is warm and relaxed, and breathes calmly. 2.2 Connecting the ECG Cable 1.

  • Page 32: Powering The Electrocardiograph

    When operating on battery power Press and hold the On/Off button on the right side of the electrocardiograph. The power light turns deep blue. After the EDAN logo is displayed on the LCD screen, the electrocardiograph is ready for use.

  • Page 33: Logging In To The Electrocardiograph

    Series Electrocardiograph User Manual Setting Up the Electrocardiograph been fully recharged but its continuous use is greatly reduced, replace the battery. CAUTION 1. If the electrocardiograph is turned off because of low battery capacity or unexpected power failure, the settings configured or the ECGs being recorded may not be saved.

  • Page 34: Configuring The Ethernet

    Series Electrocardiograph User Manual Setting Up the Electrocardiograph Using fingerprint (if enrolled before) Tap Fingerprint Identification. Press your finger on the fingerprint reader on the right side of iSE. Using user account and password Enter your user name and password. Tap Log in.

  • Page 35: Chapter 3 Preparing The Patient

    Series Electrocardiograph User Manual Preparing the Patient Chapter 3 Preparing the Patient 3.1 Instructing the Patient Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases the patient’s anxiety. Reassure the patient that the procedure is painless.
  • Page 36 Series Electrocardiograph User Manual Preparing the Patient Electrodes Locations Fourth intercostal space at the right border of the sternum White/Red Brown/Red Fourth intercostal space at the left border of the sternum White/Yellow Brown/Yellow Fifth rib between C2 and C4...
  • Page 37 - 30 -...
  • Page 38 Series Electrocardiograph User Manual Preparing the Patient Green Right leg Black Green Figure 14 C3R+C4R +C5R (Right) Electrodes Locations Right anterior chest opposite of C3 White/Pink Brown/Yellow Right anterior chest opposite of C4 White/Gray Brown/Red Right anterior chest opposite of C5...
  • Page 39 Series Electrocardiograph User Manual Preparing the Patient Electrodes Locations Left posterior axillary line on the same horizontal level as C4 and C6 White/Orange Brown/Black Left midscapular line on the same horizontal level as C4 and C7 White/Blue Brown/Blue Left paraspinal border on the same horizontal level...
  • Page 40 - 32 -...

  • Page 41: Chapter 4 Entering Patient Information

    Series Electrocardiograph User Manual Entering Patient Information Chapter 4 Entering Patient Information 4.1 Manually Entering Patient Information in the Patient tab. New Patient window will open. Enter patient information, select an ECG test and set the priority. Tap Save. The patient is available now in the Patient tab.

  • Page 42: Modifying And Deleting Patient Information

    Patient tab. You can also slide down the tab for update. NOTE: To retrieve orders from server, you need to purchase and install EDAN’s data management software in your PC. Use the recommended barcode scanner. For one-dimensional barcode, the recommend scanner is Zebra DS2208, and 1900GSR-2 for QR code.

  • Page 43: Searching Patient Information

    Series Electrocardiograph User Manual Entering Patient Information Tap and hold the patient information you want to modify. Select Edit from the pop-up menu. When finished, tap OK to save your modification. Or you can tap Cancel to cancel your modification.
  • Page 44 Series Electrocardiograph User Manual Entering Patient Information 3. Enter the sorting criteria, e.g. Outp./Inp./PE ID, name, request ID etc. Tap OK. 4. Patient information that meets the criteria is displayed. To cancel sorting, tap . Patient information before sorting is displayed.

  • Page 45: Chapter 5 Recording An Ecg

    Series Electrocardiograph User Manual Recording an ECG Chapter 5 Recording an ECG The method for recording an ECG varies depending on the type of ECG to be recorded. This chapter describes how to record the following ECG types: standard ECG (including rhythm ECG), pharmaceutical study, VCG and SAECG, and heart rate variability (HRV).

  • Page 46: Rhythm Ecg

    Series Electrocardiograph User Manual Recording an ECG To carry out pre-sample recording: 1. Select System Setting > Sampling Setting > Sampling Mode > Pre-sample. 2. Tap . ECG recording screen opens. The system automatically checks if 10s ECG has been acquired. If no, the system will continue to acquire ECG till reaching 10s. If yes, the system records and analyzes the ECG.

  • Page 47: Chapter 6 Editing Ecgs

    Series Electrocardiograph User Manual Editing ECGs Chapter 6 Editing ECGs The system can be configured to automatically analyze ECGs after recording. To manually activate ECG data analysis, tap an ECG in the ECG File tab. Then the ECG Analysis screen is displayed. In this screen, you can edit, measure, diagnose, and compare ECGs.

  • Page 48: Ecg Measurement/Diagnosis

    Series Electrocardiograph User Manual Editing ECGs 6.2 ECG Measurement/Diagnosis Manual Measurement To measure ECG waveform, open the waveform magnification page, and tap on the icon in the right lower corner. A measurement pane will be displayed. Tap once more to exit measurement.

  • Page 49: Editing Measurements/Diagnosis

    Series Electrocardiograph User Manual Editing ECGs ○ 1 Averages thumbnail The averaged complexes of standard leads and ALL are displayed. Slide the thumbnail to ○ switch from one lead to another. Tap on one lead to display its magnified averages in ○...

  • Page 50: Retrieving Diagnosis

    Series Electrocardiograph User Manual Editing ECGs QRS (ms) QRS complex duration Q-T interval / Normalized QT interval For calculation of QTc, select System Setting > Parameter QT/QTc (ms) Setting > QTc Formulas. The default formula is Bazett. You can change the formula, but this takes effect only for the ECG analysis done after this change.

  • Page 51: Comparing Ecgs

    Series Electrocardiograph User Manual Editing ECGs 1. Open the Analysis screen. 2. Tap . Select E-record from the menu. 3. You can review the patient’s electronic medical records from the server. 6.6 Comparing ECGs iSE allows you to compare ECGs with the same patient ID.

  • Page 52: Chapter 7 Printing An Ecg Report

    Series Electrocardiograph User Manual Printing an ECG Report Chapter 7 Printing an ECG Report To preview, print and share an ECG report, tap in the Analysis screen. Select Preview, Print, or Share from the menu. You can choose thermal printer (if configured) or external printer. In the case of thermal printer, the system will automatically print an ECG report.

  • Page 53: Chapter 8 Transmitting And Exporting Ecgs

    Series Electrocardiograph User Manual Transmitting and Exporting ECGs Chapter 8 Transmitting and Exporting ECGs To transmit ECGs to server: 1. Configure SFTP server in System Setting > Transmission Setting > Server Setting. 2. Open ECG File tab. 3. Tap .

  • Page 54: Chapter 9 Deleting Ecgs

    Series Electrocardiograph User Manual Deleting ECGs Chapter 9 Deleting ECGs To delete ECGs: 1. Open the ECG File tab. 2. Tap . Select the ECG report(s) you want to delete. Or tap Select All to select all the ECGs.

  • Page 55: Chapter 10 System Setting

    Series Electrocardiograph User Manual System Setting Chapter 10 System Setting To set up the iSE system, tap System Setting in the Main Menu. Options underlined are default settings. In each setting window, you need to tap Save if available to save your changes.

  • Page 56: Patient Information Setting

    Series Electrocardiograph User Manual System Setting Electrode Hint in the opposite position. The default setting is On. If selected, the system asks you if to display the pacing spike or not Intelligent Pace when it detects a pacemaker pulse.

  • Page 57: Print And Storage Setting

    Series Electrocardiograph User Manual System Setting Ward Not selected by default. Department Selected by default. Room No. Selected by default. Request ID Selected by default. Exam Room Selected by default. Exam Item Selected by default. Technician Not selected by default.
  • Page 58 Series Electrocardiograph User Manual System Setting In DICOM (Encapsulated PDF) files and DICOM (ECG Waveform) files, the value of QTc is always calculated by the Bazzet formula. Choose from: On, Off. External storage is forbidden Report Format Choose from: Pediatric mode: 3x3, 6+3, 9x1 12-lead: 3x4+1R, 6x2+1R, 12x1.
  • Page 59 Series Electrocardiograph User Manual System Setting Report addition to an automatic ECG printout. VCG (visible when activated. Settings are displayed according to the functions activated.) Record Time Choose from: 10s, 1 min, 3 min, 5 min. Report Type Choose from: VCG Report, TVCG Report, SAECG Report.

  • Page 60: Filter Setting

    Series Electrocardiograph User Manual System Setting 10.4 Filter Setting Item Description Baseline Filter ECG traces can contain some baseline wander caused by movement. You can reduce this wander of the baseline by applying a baseline filter. When you use this filter, the recorded signal is not changed.

  • Page 61: Parameter Setting

    Series Electrocardiograph User Manual System Setting the server. Time Choose from: On, Off. Synchronization When On, the system will send a synchronization request to the server each time the electrocardiograph is powered on or retrieves orders from server. And the time sent by the server is taken as the current system time.
  • Page 62 - 53 -...

  • Page 63: User Setting

    Series Electrocardiograph User Manual System Setting Item Description Axis calculation Choose from: Area Method or Amplitude Method. method Tachycardia Enter a heart rate. The default value is 100 bpm. (greater than) Bradycardia (less Enter a heart rate. The default value is 60 bpm.
  • Page 64 - 54 -...

  • Page 65: Others

    Series Electrocardiograph User Manual System Setting Item Description User Login If selected, you have to enter user name and password for login to iSE. You can also input the user’s fingerprint for login. User login is selected by default.

  • Page 66: System Update

    Series Electrocardiograph User Manual System Setting and upload ECG data to the server. Administrator Define the password required to access System Setting, the Password Patient tab (if selected), and ECG File tab (if selected). Blank by default. Enter up to 6 letters or numbers or combination of them to define the password.

  • Page 67: Chapter 11 System Message

    Series Electrocardiograph User Manual System Message Chapter 11 System Message System messages and the corresponding causes are listed below. Table 11-1 System messages and causes System Message Causes Electrodes fall off the patient or the lead Lead off: wires disconnected sampling box.

  • Page 68: Chapter 12 Cleaning, Care And Maintenance

    Series Electrocardiograph User Manual Cleaning, Care and Maintenance Chapter 12 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 69: Cleaning

    Series Electrocardiograph User Manual Cleaning, Care and Maintenance 12.2 Cleaning WARNING 1. Before cleaning, unplug the electrocardiograph from AC power if connected. Disconnect with the ECG cables. If the device or accessories has been in contact with the patient, clean and disinfect them after each use.

  • Page 70: Care And Maintenance

    3. Clean and disinfect reusable electrodes after each use. 12.4 Care and Maintenance EDAN will make available on request circuit diagrams, component part lists, descriptions, or other information that will assist service personnel to repair those parts of the equipment that are designated by EDAN as repairable by service personnel.

  • Page 71: Recharging And Replacing The Battery

    12.4.1 Recharging and Replacing the Battery Recharging the battery iSE series electrocardiograph is equipped with a recharge control circuit together with the battery. Because of consumption during storage and transportation, the battery capacity decreases. Recharge the battery prior to the first use.

  • Page 72: Thermal Chart Paper

    Series Electrocardiograph User Manual Cleaning, Care and Maintenance disposal and recycling. 4. Remove the battery from the electrocardiograph that is not in use for a long time. 5. If the battery is not used for a long time, we recommend that the battery be recharged at least once every 6 months to prevent over-discharge.
  • Page 73 Series Electrocardiograph User Manual Cleaning, Care and Maintenance The following safety checks should be performed at least every 12 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.
  • Page 74 Series Electrocardiograph User Manual Cleaning, Care and Maintenance shaking them violently when moving to another place. Prevent any liquid from seeping into the equipment; otherwise the safety and the performance of the electrocardiograph and sampling box cannot be guaranteed.

  • Page 75: Chapter 13 Accessories

    Series Electrocardiograph User Manual Accessories Chapter 13 Accessories WARNING Only the ECG cable and other accessories supplied by the manufacturer can be used. Or else, their performance and electric shock protection cannot be guaranteed. Table 13-1 Standard accessory list...
  • Page 76 Series Electrocardiograph User Manual Accessories ECG-EJ01 01.57.040169 Switching Power Adaptor UE48-190253SPA3 21.21.064244 Table 13-2 Optional accessory list Accessory Model Part Number H99SG 01.57.471858 H124SG 01.57.471859 ECG Electrodes L-00-S 01.57.471860 Medi-Trace 200 01.57.471862 Q-Trace Gold5500 01.57.471863 Electrode Adapters 98ME07GA454 01.57.040172...

  • Page 77: Chapter 14 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 78: Appendix 1 Technical Specifications

    Series 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 Comply with: IEC 60601-1-2:2014 EN 60601-1-2:2015 IEC/EN 60601-2-25 Anti-electric-shock type: Class I equipment, internally powered equipment Anti-electric-shock degree: Type CF with defibrillation-proof...

  • Page 79: A1.3 Physical Specifications

    Series Electrocardiograph User Manual Technical Specifications 15%RH~95%RH 15%RH~95%RH Relative Humidity: Non-Condensing Non-Condensing Atmospheric 70 kPa ~106 kPa 70 kPa ~106 kPa Pressure: A1.3 Physical Specifications No handle or thermal printer: 270mm(L)×170mm(W)×28mm(H), ±2mm Dimensions With handle: 270mm(L)×230mm(W)×52mm(H), ±2mm With thermal printer: 274mm(L)×274mm(W)×90mm(H), ±2mm 1.2 kg±0.3 kg (excluding thermal printer, handle, and printer paper)
  • Page 80 Series Electrocardiograph User Manual Technical Specifications HR Range 30 bpm – 300 bpm Accuracy 1 bpm AC Filter: 50Hz / 60Hz / Off DFT Filter: 0.01Hz / 0.05Hz / 0.32Hz / 0.67Hz Filter EMG Filter: 25Hz / 35Hz / 45Hz / Off...
  • Page 81 Series Electrocardiograph User Manual Technical Specifications DE18: ±750 uV to ±700 mV DE12: 30 us to 2.0 ms Width DE18: 50 us to 2.0 ms WIFI Transmitting Frequency 2.4 GHz and 5 GHz 2412 MHz – 2472 MHz (2.4GHz) Frequency Band 5150 MHz –...

  • Page 82: Appendix 2 Emc Information

    Series Electrocardiograph User Manual EMC Information Appendix 2 EMC Information Electromagnetic Emissions Guidance and manufacture’s declaration - electromagnetic emission The iSE is intended for use in the electromagnetic environment specified below. The customer or the user of the iSE should assure that it is used in such an environment.
  • Page 83 Series Electrocardiograph User Manual EMC Information The iSE is intended for use in the electromagnetic environment specified below. The customer or the user of the iSE should assure that it is used in such an environment. Electromagnetic IEC/EN 60601...
  • Page 84 - 73 -...
  • Page 85 Series Electrocardiograph User Manual EMC Information Voltage dips, Mains power quality 0 % U 0.5 cycle 0 % U 0.5 cycle short should be that of a At 0°, 45°, 90°, At 0°, 45°, 90°, interruptions and 135°, 180°, 225°, 135°, 180°, 225°, typical commercial 270°...
  • Page 86 Series Electrocardiograph User Manual EMC Information Electromagnetic Immunity Guidance and manufacture’s declaration - electromagnetic immunity The iSE is intended for use in the electromagnetic environment specified below. The customer or the user of the iSE should assure that it is used in such an environment.
  • Page 87 no closer than 30 cm (12 inches) to Where is the maximum output power rating of the transmitter in - 75 -...
  • Page 88 Series Electrocardiograph User Manual EMC Information watts according transmitter manufacturer and recommended separation distance in meters (m). Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
  • Page 89 Series Electrocardiograph User Manual EMC Information Table 1 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment IMMUNITY Test Brand Modulation Maximum Distance TEST Service Frequency (MHz) Power(W) LEVEL (MHz) (V/m) Pulse 380-390 TETRA 400 modulation 18Hz GMRS 460, ±5 kHz...
  • Page 90 Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM maybe reduce to 1m. The 1 m test distance is permitted by IEC/EN 61000-4-3. - 77 -...
  • Page 91 Series Electrocardiograph User Manual EMC Information a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
  • Page 92 Series Electrocardiograph User Manual EMC Information Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM Recommended separation distances between portable and mobile RF communications equipment and the iSE The iSE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 93: Appendix 3 Abbreviation

    Series Electrocardiograph User Manual Abbreviation Appendix 3 Abbreviation Abbreviation Statement Liquid Crystal Display Electrocardiograph/Electrocardiogram Blood Pressure Heart Rate Alternating Current Identification Alternating Current Universal Serial Bus Auto Gain Control Normal Condition Single Fault Condition Near field communication Portable Document Format...
  • Page 94 Appendix 4 Installation instructions 1. The specific use scenario and installation setting diagram of the product This device is fixed used and can not move by Non-professionals. 3.This device must operate with a minimum distance of 20 cm between the radiator and user body.

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