EDAN SE-2003 User Manual
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EDAN SE-2003 User Manual

Holter system recorder
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  • Page 2 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 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 1 Safety Guidance ........................... 1 1.1 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 2 Introduction ..........................
  • Page 5 4.3.4 LCD Contrast ........................ 22 4.3.5 Data Protection ......................22 4.3.6 Languages ........................23 4.3.7 Font ..........................23 4.3.8 Check WP Switch ......................23 4.3.9 Pole-fall Sound ......................23 4.3.10 Battery Type ........................ 24 4.3.11 Date and Time ......................24 4.3.12 Exit ..........................
  • Page 6 7 Accessories ..........................39 8 Warranty and Service Policy ....................40 8.1 Warranty ..........................40 8.2 Contact Information ......................40 Appendix 1 Technical Specifications ..................41 A1.1 Safety Specifications ......................41 A1.2 Environment Specifications ....................41 A1.3 Physical Specifications ...................... 42 A1.4 Battery Specifications .......................

  • Page 7: Safety Guidance

    SE-2003&SE-2012 Holter System Recorder User Manual 1 Safety Guidance This chapter provides important safety information related to the use of SE-2003/SE-2012 Holter System Recorder. 1.1 Intended Use The SE-2003/SE-2012 Holter System (including analysis software and recorder) is intended to record, analyze, display, edit and generate report of ambulatory ECG. It is mainly used for (but not limited to) the following indications: 1.

  • Page 8: Safety Warnings

    SE-2003&SE-2012 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 9: Alkaline Battery Care Warnings

    SE-2003&SE-2012 Holter System Recorder User Manual 1.2.2 Alkaline Battery Care Warnings WARNING 1. Do not heat or splash the battery or throw it into fire or water. 2. Do not destroy the battery; Do not pierce battery with a sharp object such as a needle;...

  • Page 10: List Of Symbols

    SE-2003&SE-2012 Holter System Recorder User Manual 1.3 List of Symbols Symbol Description Type CF equipment Caution Consult Instructions for Use Waste Electrical and Electronic Equipment (WEEE) It is the responsibility of the end user to dispose of this equipment at a designated collection point for recycling.

  • Page 11: Introduction

    SE-2012 can continuously record non-compressed and full-disclosure 12-lead ECG data for 24～ 48 hours or 3-channel ECG data for 24~96 hours . With a normal AAA alkaline battery, SE-2003 can continuously record non-compressed and full-disclosure 3-channel ECG data for 24~96 hours.

  • Page 12: Appearance

    SE-2003&SE-2012 Holter System Recorder User Manual 2.1 Appearance Please find appearance of SE-2003/SE-2012 Holter System Recorder below: Multifunctional Socket LCD Screen Left-up Key Confirmation Key Right-down Key SD Card Port Battery Cathode Battery Cover - 6 -...

  • Page 13: Lead Input/Usb Socket

    Right-down key is used to move the cursor to right or move down in menu operation mode. For detailed functions of different buttons, please refer to parameter setting section. 2.4 Data Storage SE-2003/SE-2012 stores ECG data in Secure Digital card (SD card) which will be analyzed by Holter analysis software after finishing recording. - 7 -...

  • Page 14: Capacity Requirements

    SE-2003&SE-2012 Holter System Recorder User Manual Only the SD card specified by manufacturer can be used in SE-2003/SE-2012. If you need to add or replace SD card, please contact manufacturer or dealer. Do not insert incompatible or unknown SD card into SE-2003/SE-2012 recorder. That is to avoid unnecessary damages.

  • Page 15: Battery Loading

    SE-2003&SE-2012 Holter System Recorder User Manual 2.5 Battery Loading SE-2003/SE-2012 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 USB 2.0 high-speed communication mode is simple and easy. Events button precisely records event time. NOTE: Press Confirmation key to restart SE-2003/SE-2012 if it shuts off automatically. There is no need to load battery again. - 10 -...

  • Page 17: Operation Preparations

    The performance and electric shock protection can be guaranteed only if the original patient cable and electrodes of the manufacturer are used. SE-2003/SE-2012 adopts optimized and incorporated lead structure, which can reduce potential difference disturbance during monitoring process. 3.2.1 Connecting the Patient Cable to the Recorder Connect the patient cable to the patient cable socket on the top side of the recorder.
  • Page 18 SE-2003&SE-2012 Holter System Recorder User Manual 3.2.2.1 10 Electrodes 12 Leads (AHA) White RA ● Black LA ● Green RL ● Red LL ● Red V1 ● Yellow V2 ● Green V3 ● Blue V4 ● Orange V5 ● Purple V6 (IEC) Red R ●...
  • Page 19 SE-2003&SE-2012 Holter System Recorder User Manual 3.2.2.2 5 Electrodes 3 Channels (AHA) ● 2 Brown (CH2+) ● 3 Orange (CH3+) ● 4 White (COM-) 1 Red (CH1+) ● 5 Green (RL) (IEC) 1 Green (CH1+) ● 2 White (CH2+) ● 3 Orange (CH3+) ● 4 Red (COM-) ●...
  • Page 20 SE-2003&SE-2012 Holter System Recorder User Manual 3.2.2.3 7 Electrodes 3 Channels (AHA) ● 1 Red (CH1+) ● 2 White (CH1-) ● 3 Brown (CH2+) ● 4 Black (CH2-) ● 5 Orange (CH3+) 6 Blue (CH3-) ● 7 Green (RL) (IEC) 1 Green (CH1+) ●...

  • Page 21: Preparing The Patient

    SE-2003&SE-2012 Holter System Recorder User Manual 3.3 Preparing the Patient 3.3.1 Instructing the Patient Give necessary guidance to patients before they leave: 1. Show them how to use events button and explain when to press the button; 2. Explain to the patients or nursing staff the importance of registering patient log timely and completely.

  • Page 22: Attaching The Electrodes To The Patient

    SE-2003&SE-2012 Holter System Recorder User Manual 3.4 Attaching the Electrodes to the Patient Use qualified and valid silver-silver chloride disposable monitoring electrodes specially used for the recorder. It is recommended to choose disposable electrodes complying with YY/T 0196-94 or ANIS/AAMI EC12-1991 requirements.
  • Page 23 SE-2003&SE-2012 Holter System Recorder User Manual Green C3 Green V3 In the middle of V2 and V4. Brown C4 Blue V4 Brown V4: Left Mid-Clavicular line 5 Black C5 Orange V5 Left Anterior Axillary line, the same level of V4...
  • Page 24 SE-2003&SE-2012 Holter System Recorder User Manual 3.4.1.3 7 Electrodes 3 Channels Seven-electrode-three-channel lead wires are utilized by the recorder to create a 3-channel ECG signal. Different placement positions of 7 electrodes will form different lead modes, and it is recommended to place electrodes as below:...

  • Page 25: Attaching The Electrodes

    SE-2003&SE-2012 Holter System Recorder User Manual 3.4.2 Attaching the Electrodes CAUTION The disposable electrodes can only be used for one time. Disposable Electrode Connection 1) Clean the electrode areas on the body surface with 75% alcohol. 2) Attach the disposable electrodes to the electrode positions on the body surface.

  • Page 26: Recorder Preparation

    Edan Instruments, Inc 4.1 Menu Setting SE-2003/SE-2012 employs two-level menu structure. The first level has four menu items. Use left-up key and right-down key to move cursor to select menu items. Press confirmation key to enter the second level menu of the selected menu item. Still select menu items by left-up key and right-down key in the second-level menu and then enter change status by pressing the confirmation key.

  • Page 27: Channels

    SE-2003&SE-2012 Holter System Recorder User Manual 4.2.1 Channels The number of recording channels of SE-2003 can be set to 3, 2 or 1. 4.2.2 Gain Gain can be adjusted to 0.5, 1, or 2. The default startup setting is the value adjusted last time.

  • Page 28: Patient Id Writing

    SE-2003&SE-2012 Holter System Recorder User Manual 4.3.2 Patient ID Writing E-label registration detection can be set to on or off. Default value is the value set last time. When set to on, SD card will be checked whether E-label is registered during start-up process. If not, the recorder will enter Patient ID writing process and you need to input Patient ID through keyboard.

  • Page 29: Languages

    SE-2003&SE-2012 Holter System Recorder User Manual 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. 4.3.6 Languages Language of menu and prompting message can be set to Chinese or English or other languages.

  • Page 30: Battery Type

    Set second Exit SE-2003/SE-2012 has a clock backup battery inside. Even if the battery of recorder is taken out for a long time, the clock circuit still works normally. Only if the recorder is unused for a long time or time zone is changed, the clock has to be adjusted.

  • Page 31: Screen Description

    SE-2003&SE-2012 Holter System Recorder User Manual 4.4 Screen Description 4.4.1 Start-up Picture The start-up picture below will show up for a couple of seconds when SE-2003/SE-2012 is powered on. SE-2003 HOLTER RECORDER 4.4.2 Low Battery Message 1 The warning information below will show up if battery voltage is detected to be too low and cannot operate normally.

  • Page 32: Inserting Sd Card Message

    SE-2003&SE-2012 Holter System Recorder User Manual WARNING If you operate the recorder for less than 24 hours, you can choose Yes to continue. Otherwise you need to replace it with new battery. 4.4.4 Inserting SD Card Message The prompt message below will show up if no SD card is detected when the recorder starts up.

  • Page 33: Write-Protect Of Sd Card Message

    SE-2003&SE-2012 Holter System Recorder User Manual 4.4.6 Write-protect of SD Card Message The prompt message below will show up if write-protect switch is detected to be at Lock position and item of data protect under Advanced setting is set to on. The recorder will shut off in 60 seconds.

  • Page 34: Automatic Shutdown Message

    SE-2003&SE-2012 Holter System Recorder User Manual 4.4.9 Automatic Shutdown Message The recorder will automatically shut off in non-recording state and when no action on keyboard is performed for 15 minutes. The prompt message below will show up and last 5 seconds before recorder shuts off.

  • Page 35: Recording

    5 Recording 5.1 Overview The operation steps of SE-2003/SE-2012 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 36: Start Recording

    SD card surface manually; 2. Insert the SD card into SE-2003/SE-2012 Holter System Recorder (or unplug USB cable); 3. Attach electrodes on patient as per guidance mentioned in previous section and then insert patient cable into recorder;...

  • Page 37: Ecg Preview

    SE-2003&SE-2012 Holter System Recorder User Manual ID: 2345604560 Name: Mary Reset Press OK to enter next step. Press Reset to reset the patient information. 5.2.3 ECG Preview The process will be skipped if the setting of ECG preview is off under Advance Setting menu.

  • Page 38: Recording Status

    If recording time is not 24 hours, reverse signal of 2, 3, 4, 0 (continuous recording) will show up; If recording channel of SE-2003 is set to 3, reverse signal of 3 will show up; If recording channel of 3-channel recording is set to 2 or 1, reverse number of 2 or 1 will show If electrodes fall during recording process, reverse signal of the name of fallen electrode will show up;...

  • Page 39: Ecg Display

    SE-2003&SE-2012 Holter System Recorder User Manual 5.3.2 ECG Display If ECG display is set to on in advanced setting menu, only one second is needed to shift to real-time waveform display mode by pressing left-up key and confirmation key together. Users can observe the validity of recorded waveform.

  • Page 40: Data Transmission

    5.5 Data Transmission After the end of recording, the collected data shall be transmitted to analysis software to make analysis and diagnosis. SE-2003/SE-2012 supports transmission by SD card or connection by USB cable. And these two methods are equally effective: 5.5.1 Transmit by SD Card...
  • Page 41 SE-2003&SE-2012 Holter System Recorder User Manual Linking PC … It means correct connection of the recorder with computer. A new disk signal and files under this disk can be found under resource manager of operating system. The next step is to run analysis system program.

  • Page 42: Cleaning, Care And Maintenance

    SE-2003&SE-2012 Holter System Recorder User Manual 6 Cleaning, Care and Maintenance CAUTION 1. Remove the battery and the patient cable from the recorder before cleaning. 2. Prevent any liquid from seeping into the recorder; otherwise the safety and the performance of the recorder can not be guaranteed.

  • Page 43: Maintenance Of The Recorder And The Patient Cable

    SE-2003&SE-2012 Holter System Recorder User Manual 6.2.2 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 44 SE-2003&SE-2012 Holter System Recorder User Manual 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.

  • Page 45: Accessories

    SE-2003&SE-2012 Holter System Recorder User Manual 7 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...

  • Page 46: Warranty And Service Policy

    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 47: Appendix 1 Technical Specifications

    SE-2003&SE-2012 Holter System Recorder User Manual Appendix 1 Technical Specifications A1.1 Safety Specifications IEC 60601-1:1988+A1:1991+A2:1995 EN 60601-1:1990+A1:1993+A2:1995 Comply with: IEC60601-1-2:2001+A1:2004 EN 60601-1-2:2001+A1:2006 IEC/EN 60601-2-47 Anti-electric-shock type: Internal power supply Anti-electric-shock degree: Type CF Degree of protection against Ordinary equipment (Sealed equipment without liquid...

  • Page 48: A1.3 Physical Specifications

    SE-2003&SE-2012 Holter System Recorder User Manual Atmospheric Pressure: 700hPa ~1060hPa 860hPa ~1060hPa A1.3 Physical Specifications Dimensions 68mm × 53mm × 16 mm (2.68 in × 2.08 in × 0.63in) Weight Approx. 42 g (0.1 lbs) (excluding battery) Enclosure Molded plastic / water resistant...

  • Page 49: Appendix 2 Emc Information

    SE-2003&SE-2012 Holter System Recorder User Manual Appendix 2 EMC Information Guidance and manufacture’s declaration - electromagnetic emissions- for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic emission Holter System Recorder is intended for use in the electromagnetic environment specified below.
  • Page 50 SE-2003&SE-2012 Holter System Recorder User Manual Guidance and manufacture’s declaration - electromagnetic immunity - for all EQUIPMENT and SYSTEMS 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 51 SE-2003&SE-2012 Holter System Recorder User Manual Guidance and manufacture’s declaration - electromagnetic immunity - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity Holter System Recorder is intended for use in the electromagnetic environment specified below.
  • Page 52 SE-2003&SE-2012 Holter System Recorder User Manual Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitter, an electromagnetic site survey should be considered.

This manual is also suitable for:

Se-2012

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