About this Manual P/N: 01.54.455144-13 Release Date: April 2014 © Copyright EDAN INSTRUMENTS, INC. 2010-2014. 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. (hereinafter called EDAN) can not be held liable.
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. NOTE A NOTE provides useful information regarding a function or a procedure.
Table of Contents 1 Safety Guidance........................................................................................................................... 1 1.1 Intended Use........................................................................................................................... 1 1.2 Warnings and Cautions .......................................................................................................... 1 1.2.1 Safety Warnings ....................................................
4.3.4 LCD Contrast ................................................................................................................ 22 4.3.5 Data Protection .............................................................................................................. 22 4.3.6 Languages ..................................................................................................................... 23 4.3.7 Font .............................................................................................
7 Accessories ................................................................................................................................. 39 8 Warranty and Service Policy ................................................................................................... 40 8.1 Warranty ............................................................................................................................... 40 8.2 Contact Information ................................................................
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. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2.
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. Please pay more attention to the following warning and caution information. 1.2.1 Safety Warnings WARNING 1. The recorder is intended to be used by qualified physicians or personnel professionally trained.
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; Do not hit with a hammer, step on or throw or drop to cause strong shock; Do not disassemble or modify the battery. 3. When leakage or foul smell is found, stop using the battery immediately.
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. Year of Manufacture Manufacturer SN Serial Number Insert SD card in the direction the arrow indicates.
SE-2003&SE-2012 Holter System Recorder User Manual 2 Introduction The manual mainly describes how to operate and maintain SE-2003/SE-2012 Holter System Recorder (thereafter referred as SE-2003/SE-2012). SE-2003/SE-2012 plus SE-2003/SE-2012 Holter Analysis System compose SE-2003/SE-2012 Holter System. For the operation of analysis software, refer to software manual.
SE-2003&SE-2012 Holter System Recorder User Manual 2.
SE-2003&SE-2012 Holter System Recorder User Manual 2.2 Lead Input/USB Socket SE-2003/SE-2012 is featured by a 26-pin lead input/USB multi-functional connector socket. It serves as lead input socket when collecting records. After recording finishes, insert USB cable into the socket and data could be read into analysis system through USB 2.0 high speed transfer.
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. CAUTION SD card is a light and precise device. Do not knock or bend it or insert articles into the jacks.
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. NOTE: There is battery type setting in the setting menu of SE-2003/SE-2012: alkaline battery and Ni-MH battery.
SE-2003&SE-2012 Holter System Recorder User Manual not be mixed up when reviewing data package. Numerous data are included in the package like hospital, signal channel, sampling rate, event information, recording date and time, so as to facilitate data management and exchange. z Leads-off warning: Poor electrode connection will be warned by voice or icon.
SE-2003&SE-2012 Holter System Recorder User Manual 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. 3.1 Requested Materials 1. 2. 3. 4. 5. 6.
SE-2003&SE-2012 Holter System Recorder User Manual 3.2.2.
SE-2003&SE-2012 Holter System Recorder User Manual 3.2.2.
SE-2003&SE-2012 Holter System Recorder User Manual 3.2.2.
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. Introduce writing format, contents, what to record, recording time, location, activities and self-feeling in detail; 3.
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. 3.4.1 Electrode Placement The application of electrodes should be performed by trained medical personnel.
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 5th rib Black C5 Orange V5 Left Anterior Axillary line, the same level of V4 Purple C6 Purple V6 Left Middle Axillary line, the same level of V4 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.
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: IEC AHA Electrode Placement Green (CH1+) Red (CH1+) Left Anterior Axillary line 6th rib. Red (CH1-) White (CH1-) Right Manubrial border of the Sternum.
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. 3) Clip the disposable electrodes with the lead wires. The quality of ECG waveform will be affected by the contact resistance between the patient and the electrode.
SE-2003&SE-2012 Holter System Recorder User Manual 4 Recorder Preparation The menu displays recorder model, serial number, firmware version and manufacturer information. All information is set before final sale and cannot be modified by users. SE-2003 Holter Recorder Recorder SN: 456789 Firmware Version: 3.1 Manufactured by Edan Instruments, Inc 4.1 Menu Setting SE-2003/SE-2012 employs two-level menu structure. The first level has four menu items.
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. 4.2.3 Recording time Record time can be set to 1 day, 2 days, 3 days, 4 days or Cont. Default value is 1 day. Cont means no recording time limit. The recording won’t stop until the battery runs out. NOTE: Long-time recording needs software support.
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. When set to off, the recorder will skip Patient ID writing process, which will not affect normal E-label registration process.
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. Default value is the value set last time. Language: English Font: Large Check WP Switch: On Pole-off sound: On Battery type: Alkaline 4.3.
SE-2003&SE-2012 Holter System Recorder User Manual 4.3.10 Battery Type Battery type used for the recorder can be set to alkaline or Ni-MH. Default value is the value set last time. There are great differences on initial discharge voltage and final discharge voltage between alkaline battery and NI-MH battery. Please set it to be real battery type in use so as to ensure more accurate warning for battery under voltage. 4.3.11 Date and Time Adjust year-month-date and hour-minute-second of real-time clock.
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. The recorder will automatically shut off in 30 seconds. WARNING!!! Low Battery. Power off in 30 seconds. 4.4.
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. Recorder will wait until user inserts SD card. SD card not found. Please insert. 4.4.
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. WARNING!!! SD card is locked. ECG can’t be recorded. 4.4.
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. WARNING!!! No key activity in 15 minutes. Power off in 5 seconds! 4.4.
SE-2003&SE-2012 Holter System Recorder User Manual 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. The registered SD cards prevent possible confusion caused by recording of different patients at the same time; 3. Place electrodes; 4.
SE-2003&SE-2012 Holter System Recorder User Manual 1. Make electronic labeling registration of SD card (recorder) in analysis system or other specialized software, or stick the labeling on the 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; 4. Load one AAA battery in correct polarity; 5.
SE-2003&SE-2012 Holter System Recorder User Manual ID: 2345604560 Name: Mary OK 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. The upper part displays one-channel ECG wave, while the bottom displays name of the lead (channel) ( I, II, III, aVR, aVF, aVL, V1, V2, V3, V4, V5, V6 or CH1, CH2, CH3 in 3-channel mode).
SE-2003&SE-2012 Holter System Recorder User Manual 5.3 Recording Status The SE-2003/SE-2012 will shift from recording process to information display mode to display current date, time, recording time, patient information and recording parameters. Only one second is needed to shift to real-time waveform display mode by pressing left-up key and confirmation key together. 5.3.
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. Display one lead (channel) ECG waveform, bottom center displays the name of lead (channel) (I, II, III, aVR, aVF, aVL, V1, V2, V3, V4, V5, V6 or CH1, CH2, CH3 under 3-channle mode).
SE-2003&SE-2012 Holter System Recorder User Manual WARNING 1. Electrodes are for one-off use only as they may cause cross infection between different patients. Repeated use is forbidden! 2. For disposal of abandoned electrodes, please follow hospital requirements or local laws and regulations. Do not discard them carelessly. After necessary cleaning and disinfection to recorder and leads, it is well prepared for the next patient. 5.
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. 4.
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. 6.1 Cleaning the Patient Cable CAUTION Any remainder of detergent should be removed from the patient cable after cleaning. To clean the patient cable: 1.
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. a) Inspect the recorder and accessories for mechanical and functional damage.
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. ♦ Store the lead wires in a big wheel to prevent any people from stumbling.
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 Quantity Patient Cable 1 SD Card 1 Belt Clip 1 Waistband 1 AAA alkaline battery 2 The Holter system recorder and accessories are available by contacting the manufacturer or your local distributor.
SE-2003&SE-2012 Holter System Recorder User Manual 8 Warranty and Service Policy 8.1 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. b) Subsequent damage caused by improper use or maintenance. c) Damage caused by alteration or repair by anyone not authorized by EDAN.
SE-2003&SE-2012 Holter System Recorder User Manual Appendix 1 Technical Specifications A1.
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 Operating position Belt Clip, Lanyard A1.4 Battery Specifications Battery type 1 AAA alkaline battery or Ni-MH battery Battery life Alkaline battery ≥ 48 hours A1.
SE-2003&SE-2012 Holter System Recorder User Manual Appendix 2 EMC Information Guidance and manufacture’s declaration - electromagnetic emissionsfor all EQUIPMENT and SYSTEMS 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.
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.
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. The customer or the user of Holter System Recorder should assure that it is used in such an environment.
SE-2003&SE-2012 Holter System Recorder User Manual a b 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.