EDAN INSTRUMENTS SE-2003 Series User Manual
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EDAN INSTRUMENTS SE-2003 Series User Manual

Holter system recorder
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Summary of Contents for EDAN INSTRUMENTS SE-2003 Series

  • Page 1 About this Manual...
  • Page 2 P/N: 01.54.456520 MPN: 01.54.456520019 Release Date: April 2020 © Copyright EDAN INSTRUMENTS, INC. 2014-2020. All rights reserved. Statement 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.
  • Page 3 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 4: Table Of Contents

    Table of Contents Chapter 1 Safety Guidance ......................1 1.1 Indications for Use/Intended Use ................... 1 1.2 Warnings and Cautions ......................1 1.2.1 Safety Warnings ......................2 1.2.2 Alkaline Battery Care Warnings ..................3 1.2.3 General Cautions ......................3 1.3 List of Symbols ........................4 Chapter 2 Introduction ........................
  • Page 5 7.2.1 Cleaning the Recorder ....................26 7.2.2 Cleaning the Patient Cable .................... 26 7.3 Disinfection .......................... 26 7.3.1 Disinfecting the Recorder ..................... 27 7.3.2 Disinfecting the Patient Cable ..................27 7.4 Care and Maintenance ......................27 7.4.1 Visual Inspection ......................27 7.4.2 Maintenance of the Recorder and the Patient Cable .............

  • Page 6: Chapter 1 Safety Guidance

    SE-2003&SE-2012 Series Holter System Recorder User Manual Chapter 1 Safety Guidance This chapter provides important safety information related to the use of SE-2003/SE-2012 series Holter System Recorder. 1.1 Indications for Use/Intended Use The SE-2003&SE-2012 Series Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG.

  • Page 7: Safety Warnings

    SE-2003&SE-2012 Series Holter System Recorder User Manual In order to use the recorder 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.

  • Page 8: Alkaline Battery Care Warnings

    SE-2003&SE-2012 Series Holter System Recorder User Manual WARNING 14. The belt, Lanyard, and protective case cannot contact the skin directly. 15. The recorder shall not be serviced or maintained while in use with a patient. 16. The medical electrical equipment needs to be installed and put into service according to Appendix 2 EMC information.

  • Page 9: List Of Symbols

    SE-2003&SE-2012 Series Holter System Recorder User Manual required to cool from the maximum storage temperature till it is ready for intended use is at least 2 hours. 4. Do not use the recorder in a dusty environment with bad ventilation or in the presence of corrosive.
  • Page 10 SE-2003&SE-2012 Series Holter System Recorder User Manual MANUFACTURER CE marking AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Disposal method Insert SD card in the direction the arrow indicates. 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;...
  • Page 11 SE-2003&SE-2012 Series Holter System Recorder User Manual Stacking limit by number Handle with care Do not step on Front NOTE: The user manual is printed in black and white. - 6 -...

  • Page 12: Chapter 2 Introduction

    SE-2003&SE-2012 Series Holter System Recorder User Manual Chapter 2 Introduction The manual mainly describes how to operate and maintain SE-2003/SE-2012 series Holter System Recorder (thereafter referred as SE-2003/SE-2012 series). The SE-2003/SE-2012 series Holter Analysis System consists of the recorder and analysis software. For the operation of analysis software, refer to software manual.

  • Page 13: Appearance

    SE-2003&SE-2012 Series Holter System Recorder User Manual 2.1 Appearance Please find appearance of SE-2003/SE-2012 Holter System Recorder below: Multifunctional Socket LCD Screen Direction Keys Confirmation Key   Move the cursor Long press to power on  Confirm operation  Record an event ...

  • Page 14: Data Storage

    SE-2003&SE-2012 Series Holter System Recorder User Manual 2.2 Data Storage SE-2003/SE-2012 series stores ECG data in Secure Digital card (SD card) which will be analyzed by Holter analysis software after finishing recording. Only the SD card specified by manufacturer can be used in SE-2003/SE-2012 series. If you need to add or replace SD card, please contact manufacturer or dealer.

  • Page 15: Battery Loading

    SE-2003&SE-2012 Series Holter System Recorder User Manual 2.4 Battery Loading SE-2003/SE-2012 series is powered by one AAA battery. Large capacity AAA alkaline battery is recommended. Press mark on battery compartment on the back of recorder by thumb and push outwards with force. The cover of battery compartment will open. Load one AAA battery according to polarity indication inside battery compartment.

  • Page 16: Features

    SE-2003&SE-2012 Series Holter System Recorder User Manual 2.5 Features  SE-2012 Holter System Recorder is able to create standard 12 leads or 3 channels full ECG data;  EDAN's unique multi-channel pacemaker detect circuit effectively prevents wrong detection of pacemaker signal caused by all kinds of artifacts (such as movement, polarized voltage and skin impedance) and missing detection caused by software detecting only.

  • Page 17: Chapter 3 Operation Preparations

    SE-2003&SE-2012 Series Holter System Recorder User Manual Chapter 3 Operation Preparations WARNING Before use, the recorder, 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, and make sure that the equipment is in proper working condition.

  • Page 18: Cleaning The Skin

    SE-2003&SE-2012 Series Holter System Recorder User Manual 3.2.2 Cleaning the Skin Thorough skin preparation is very important. The skin is a poor conductor of electricity and frequently creates artifacts that distort the ECG signals. By performing methodical skin preparation, you can greatly reduce the possibility of noise caused by muscle tremor and baseline drift, ensuring high-quality ECG waves.
  • Page 19 SE-2003&SE-2012 Series Holter System Recorder User Manual 3.4.1.1 10 Electrodes 12 Leads 10-electrode standard lead wires are utilized by the recorder (12-channel) to create a 12-lead ECG signal. Electrode Placement Red R White RA Below clavicle, close to right shoulder. Yellow L Black LA Below clavicle, close to left shoulder.
  • Page 20 SE-2003&SE-2012 Series Holter System Recorder User Manual 3.4.1.2 5 Electrodes 3 Channels Five-electrode-three-channel lead wires are utilized by the recorder to create a 3-channel ECG signal. Electrode Placement White Right Manubrial border of the Sternum. (COM-) (COM-) Green Fifth intercostal space on the left anterior axillary line, equivalent to (CH1+) (CH1+) V5 breast lead.

  • Page 21: Attaching The Electrodes

    SE-2003&SE-2012 Series Holter System Recorder User Manual Electrode Placement Green Fifth intercostal space on the left anterior axillary line, Red (CH1+) (CH1+) equivalent to V5 breast lead. Red (CH1-) White (CH1-) Right Manubrial border of the Sternum. White Brown Approximately 1 inch right of Xiphoid Process on the rib. (CH2+) (CH2+) Yellow...

  • Page 22: Chapter 4 Ecg Sampling

    SE-2003&SE-2012 Series Holter System Recorder User Manual Chapter 4 ECG Sampling 4.1 Overview The operation steps of SE-2003/SE-2012 series recorder are as follows: 1. Decide recording plan, such as lead mode, pacemaker pulse data needed or not; 2. Insert SD card into card-reader of analysis system or directly connect it with analysis system via USB cable to register E-label.

  • Page 23: Start Ecg Sampling

    SE-2003&SE-2012 Series Holter System Recorder User Manual 4.2 Start ECG Sampling - 18 -...

  • Page 24: Sampling

    SE-2003&SE-2012 Series Holter System Recorder User Manual NOTE: 1. If the patient has been registered in the analysis software beforehand, the recorder enters the recording screen directly. 2. The inner-placed clock in SE-2003/SE-2012 series exactly records starting and ending time which can be obtained from creating time of event files or data files afterwards.
  • Page 25 SE-2003&SE-2012 Series Holter System Recorder User Manual 4. Press together, a dialog box will be displayed. Press to move the cursor to Yes, and then press to stop recording. Directly taking out battery will also terminate recording, while it may cause damages to data. SD card may have to be scanned and repaired through disk scanning program of operating system, which shall be avoided.

  • Page 26: Data Transmission

    SE-2003&SE-2012 Series Holter System Recorder User Manual 4.5 Data Transmission After the end of recording, the collected data shall be transmitted to analysis software to make analysis and diagnosis. Data Transmission Transmit by SD Card Transmit through USB Cable Take out the SD card Remove the patient cable Insert the SD to the card-reader Connect the recorder and host of...

  • Page 27: Chapter 5 System Setting

    SE-2003&SE-2012 Series Holter System Recorder User Manual Chapter 5 System Setting After setting the parameters, press Exit to return to upper level menu. NOTE: The underlined options are the default value. 5.1 Basic Setting Item Description For SE-2003 or SE-2012 connected with 5- or 7-electrode patient cable, the Channels number of recording channels can be set to 3, 2 or 1.

  • Page 28: Advanced Setting

    SE-2003&SE-2012 Series Holter System Recorder User Manual Item Description NOTE: Please confirm that your analysis system supports this function. It's suggested to turn on this setting to effectively prevent the unanalyzed data from being deleted unexpectedly. Language Set the system language. Battery type used for the recorder can be set to alkaline or Ni-MH.

  • Page 29: Chapter 6 Hint Information

    SE-2003&SE-2012 Series Holter System Recorder User Manual Chapter 6 Hint Information Hints Description The warning message will show up if battery is detected to be under voltage and cannot support long-time recording. If you choose No to stop recording, the recorder will automatically shut off in 5 seconds; if you choose Yes , the recorder will keep working.

  • Page 30: Chapter 7 Cleaning, Care And Maintenance

    Warranty does not cover damage caused by using unapproved substances or methods. Edan Instruments has validated the cleaning and disinfection instructions provided in this User Manual. It is the responsibility of the healthcare professional to ensure that the instructions are followed so as to ensure adequate cleaning and disinfection.

  • Page 31: Cleaning The Recorder

    SE-2003&SE-2012 Series Holter System Recorder User Manual The validated cleaning agents for cleaning the device and reusable accessories are:  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.

  • Page 32: Disinfecting The Recorder

    SE-2003&SE-2012 Series Holter System Recorder User Manual disinfectants for disinfecting the device 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.
  • Page 33 SE-2003&SE-2012 Series Holter System Recorder User Manual  Check the case and display screen for cracks or other damage.  Regularly inspect all plugs, cords, cables, and connectors for fraying or other damage.  Verify that all cords and connectors are securely seated. ...

  • Page 34: Maintenance Of The Recorder And The Patient Cable

    SE-2003&SE-2012 Series Holter System Recorder User Manual 7.4.2 Maintenance of the Recorder and the Patient Cable CAUTION Besides the maintenance requirements recommended in this manual, comply with local regulations on maintenance and measurement. 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.
  • Page 35 SE-2003&SE-2012 Series Holter System Recorder User Manual regularly. Make sure that it is conductible. ♦ Align the patient cable to avoid twisting, knotting or crooking in a closed angle while using it. ♦ 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.

  • Page 36: Chapter 8 Accessories

    SE-2003&SE-2012 Series Holter System Recorder User Manual Chapter 8 Accessories 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 7-1 Accessory List Accessory Part Number 10 Electrodes Patient Cable(AHA)

  • Page 37: Chapter 9 Warranty And Service

    SE-2003&SE-2012 Series Holter System Recorder User Manual Chapter 9 Warranty and Service 9.1 Warranty EDAN warrants that EDAN's products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in the case of: a) Damage caused by handling during shipping.

  • Page 38: Appendix 1 Technical Specifications

    SE-2003&SE-2012 Series Holter System Recorder User Manual Appendix 1 Technical Specifications A1.1 Safety Specifications IEC 60601-1:2005/A1:2012 EN 60601-1:2006/A1:2013 IEC 60601-1-2:2014 Comply with: EN 60601-1-2:2015 IEC/EN 60601-2-47 IEC 60601-1-11 Anti-electric-shock type: Internal power supply Anti-electric-shock degree: Type CF Degree of protection against SE-2003 &...

  • Page 39: A1.2 Environment Specifications

    SE-2003&SE-2012 Series Holter System Recorder User Manual A1.2 Environment Specifications Transport & Storage Working -20 º C (-4 º F) to +55 º C +5 º C (+41 º F) to +45 º C Temperature: (+131 º F) (+113 º F) 10%RH - 95%RH 10%RH - 95%RH Relative Humidity:...
  • Page 40 SE-2003&SE-2012 Series Holter System Recorder User Manual Gain 5 mm/mV, 10 mm/mV, 20 mm/mV, ± 5% ≥ 100 dB CMRR A/D Sampling Frequency 25.6 kHz 24 bits 50 μVp-p Minimum Amplitude Resolution 19.53 uV/LSB Pacemaker Detection ± 1 mV ~ ± 200 mV, 0.1 ms ~ 2.0 ms ECG Signal Acquisition Through screen of the recorder Verification...

  • Page 41: Appendix 2 Emc Information

    SE-2003&SE-2012 Series Holter System Recorder User Manual Appendix 2 EMC Information Electromagnetic Emissions Guidance and manufacture's declaration – electromagnetic emission Holter System Recorder is intended for use in the electromagnetic environment specified below. The customer or the user of Holter System Recorder should assure that it is used in such an environment.
  • Page 42 SE-2003&SE-2012 Series Holter System Recorder User Manual Electromagnetic Immunity Guidance and manufacture's declaration – electromagnetic immunity Holter System Recorder is intended for use in the electromagnetic environment specified below. The customer or the user of Holter System Recorder should assure that it is used in such an environment.
  • Page 43 SE-2003&SE-2012 Series Holter System Recorder User Manual Voltage dips, short 0 % U ; 0.5 cycle Not applicable interruptions applicable At 0° , 45° , 90° , voltage variations 135° , 180° , 225° , on power supply 270° and 315° input lines IEC/EN 61000-4-11 0 % U...
  • Page 44 SE-2003&SE-2012 Series Holter System Recorder User Manual  800 MHz to 2.7 GHz at RF wireless communications equipment bands (Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Holter System Recorder, including cables specified by the manufacturer).
  • Page 45 SE-2003&SE-2012 Series Holter System Recorder User Manual MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz . The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
  • Page 46 SE-2003&SE-2012 Series Holter System Recorder User Manual Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment IMMUNITY Test Brand Modulation Maximum Distance TEST Frequency Service (MHz) Power(W) LEVEL (MHz) (V/m) Pulse 380-390 TETRA 400 modulation 18Hz GMRS 460, ±...
  • Page 47 SE-2003&SE-2012 Series Holter System Recorder User Manual 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. Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM Recommended separation distances between...

This manual is also suitable for:

Se-2012 seriesSe-2012Se-2012aE-2003Se-2003a

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