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Edan Instruments, Inc. VE-300 User Manual

Veterinary electrocardiograph
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EDAN INSTRUMENTS, INC
.
Manual Ver: V1.2
Release Date: March 2009
Part Number: MS1R-107182-V1.2

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Summary of Contents for Edan Instruments, Inc. VE-300

  • Page 1 EDAN INSTRUMENTS, INC Manual Ver: V1.2 Release Date: March 2009 Part Number: MS1R-107182-V1.2...
  • Page 2 P/N： MS1R-107182-V1.2 Copyright © Copyright EDAN INSTRUMENTS, INC. 2008-2009. 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 Using This Label Guide 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 Safety Warnings......................1 1.3 Battery Care Warnings....................3 1.4 General Cautions......................4 1.5 Cleaning & Disinfection Cautions................5 2 Introduction..................6 2.1 Function Features......................6 2.2 List of Symbols......................7 3 General Information................10 3.1 Top Panel ........................
  • Page 5 5.8.2 Record Settings ....................34 5.8.3 Record Output Settings .................. 35 5.8.4 Other Record Settings ..................36 5.8.5 Save and Transmitting Settings ..............37 5.8.6 General Settings....................38 5.8.7 System Settings....................39 5.8.8 Default Settings ....................40 5.9 AUTO mode record....................42 5.10 RHYTHM mode record ...................

  • Page 6: Safety Guidance

    Please pay more attention to the following warning and caution information. 1.1 Intended use The intended use of VE-300 Veterinary Electrocardiograph is to acquire ECG signals from animals through body surface with ECG electrodes. The VE-300 Veterinary Electrocardiograph is only intended to be used in animal hospitals or animal clinics by veterinarians. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease.
  • Page 7 VE-300 Veterinary Electrocardiograph User Manual 7. If the integrity of external protective conductor in installation or arrangement is in doubt, the equipment should be operated by using a built-in rechargeable battery. 8. Do not use this equipment in the presence of high static electricity or high voltage equipment which may generate sparks.

  • Page 8: Battery Care Warnings

    VE-300 Veterinary Electrocardiograph User Manual medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or your local distributor. 19. The summation of leakage current should never exceed leakage current limits while several other units are used at the same time.

  • Page 9: General Cautions

    VE-300 Veterinary Electrocardiograph User Manual 1.4 General Cautions CAUTION 1. Avoid liquid splash and excessive temperature. The temperature must be kept ℃ ℃ ℃ between 5 and 40 while working, and it should be kept between -20 ℃ during transportation & storage.

  • Page 10: Cleaning & Disinfection Cautions

    VE-300 Veterinary Electrocardiograph User Manual h) Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC/EN 60601-1: Limit: 50uA (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 11: Introduction

    Either mains supply or built-in rechargeable Lithium battery can be used as power. With a high resolution thermal printer, a 32-bit processor and a huge capacity memorizer, VE-300 has advanced performance and high reliability, and the compact size makes it suitable for clinic and hospital use.

  • Page 12: List Of Symbols

    VE-300 Veterinary Electrocardiograph User Manual ♦ Automatic adjustment of baseline for optimal recording ♦ Standard input/output interface, RS232 communication interface and net port for linking to special network and setting up ECG database 2.2 List of Symbols External output External input Equipment or part of CF type with defibrillator proof Attention –...
  • Page 13 VE-300 Veterinary Electrocardiograph User Manual Recall key 1mV calibration key& Copy key Mode/RST switch key Lead switch key Print/Stop key ON/OFF key Menu key Up Arrow/Down Arrow key Left Arrow/ Right Arrow key Recycle Part Number Serial Number...
  • Page 14 VE-300 Veterinary Electrocardiograph User Manual Date of Manufacture Manufacturer Authorized Representative in the European Community CE Mark The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life and that this unit was put on the market after 13 August 2005.

  • Page 15: General Information

    VE-300 Veterinary Electrocardiograph User Manual 3 General Information 3.1 Top Panel Label LCD Screen Recorder Control Panel Figure 3-1 Main Unit Product Information: (Trade mark) VET ECG (Trade name) (Classification Symbol, equipment of CF type with defibrillator proof) 3.1.1 LCD Screen The LCD Screen specification: 192×64 dot single color LCD Screen.

  • Page 16: Control Panel And Keys

    VE-300 Veterinary Electrocardiograph User Manual First Row: ♦ Record mode(AUTO, MANUAL, RHYTHM, USBPRT or OFF) ♦ Hint information (Paper?, Printing, Sampling, Bat Weak etc.) ♦ Sex (M/F) and Age Second Row: ♦ Current lead (І, П, Ш, aVR, aVL, aVF, V) ♦...
  • Page 17 VE-300 Veterinary Electrocardiograph User Manual Battery recharging indicator lamp: when the battery is recharged, this lamp will be lit. 2) SENS (Sensitivity Switch Key) The sensitivity switching order: ×10 mm/mV→×20 mm/mV → AGC→×2.5 mm/mV→ ×5 mm/mV. And AGC means auto gain control.
  • Page 18 VE-300 Veterinary Electrocardiograph User Manual Table 3-1 Lead Group Switching Order of Different Mode Mode Switching Order (from left to right) І/П/Ш Standard aVR/aVL/aVF AUTO Cabrera aVL/ I /-aVR II /aVF/ III In this mode, need to press Lead Switch Key to change the lead ,...

  • Page 19: Patient Cable Socket And Signal Interface

    VE-300 Veterinary Electrocardiograph User Manual (hereinafter called Up/Down) During MENU setting, the two keys can also be pressed to select the item of which the setting is to be changed. 11) Left Arrow/ Right Arrow Press these keys to change the content of the selected item. During MENU setting, these keys can also be pressed to change the content of the selected item.
  • Page 20 VE-300 Veterinary Electrocardiograph User Manual Definition of corresponding pins: Signal Signal Signal F/LL (input) C /V(input) R /RA(input) L /LA(input) N or RF /RL(input) Note: The left side of “/” is European standard; and the right side is American standard.
  • Page 21 VE-300 Veterinary Electrocardiograph User Manual Definition of corresponding pins: Signal Signal ECG Signal (input) ECG Signal (output) 4) USB Interface Definition of corresponding pins: Signal Signal VBUS WARNING : Only the USB equipments recommended by EDAN can be connected to the USB interface.

  • Page 22: Mains Connection And Switch

    VE-300 Veterinary Electrocardiograph User Manual 3.3 Mains Connection and Switch Potential equalization terminal Mains Power Switch Mains Supply Socket 1) Potential Equalization Terminal Potential equalization conductor provides a connection between the unit and the potential equalization bus bar of the electrical installation.

  • Page 23: Bottom Panel

    VE-300 Veterinary Electrocardiograph User Manual 3.5 Bottom Panel Mains Supply Shift Switch Battery Compartment Fuse Fuse Label Label -18-...
  • Page 24 VE-300 Veterinary Electrocardiograph User Manual 1) Battery Compartment The battery label indicates the rated voltage and rated capacity of rechargeable Lithium battery pack. Rated voltage: 14.8V, Rated capacity: 2000mAh /2200mAh /2400mAh. Attention – general warning (see accompanying document) WARNING Improper operation may cause the battery to be hot, ignited or exploded, and it may lead to the decrease of battery’s capacity.
  • Page 25 VE-300 Veterinary Electrocardiograph User Manual WARNING : Ruptured fuse must only be replaced with that of the same type and rating as the original. -20-...

  • Page 26: Operation Preparations

    VE-300 Veterinary Electrocardiograph User Manual 4 Operation Preparations CAUTION Before use, the equipment, patient cable and electrodes should be checked. Replace it if there is any evident defectiveness or aging which may impair the safety or performance, and be sure that the equipment is in proper working condition.

  • Page 27: Loading/Replacing Record Paper

    Please refer to the maintenance section for how to recharge the battery. During recharging the battery, VE-300 can be powered by mains supply. WARNING : Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical installation when necessary.

  • Page 28: Patient Cable Connection

    VE-300 Veterinary Electrocardiograph User Manual Take off the wrapper of thermal paper roll, and then put through the roller from the left with the paper’s grid side facing downward; Place the paper and roller gently in the recorder with the roller pin on the roller’s left side facing to the groove;...

  • Page 29: Electrode Connection

    VE-300 Veterinary Electrocardiograph User Manual 4.4 Electrode Connection Clamp The identifier and color code of electrode connectors used complies with IEC/EN requirements. In order to avoid incorrect connections, the electrode identifier and color code are specified in Table 4-1. Moreover the equivalent code according to American requirements is given too.

  • Page 30: Inspection Before Power-On

    VE-300 Veterinary Electrocardiograph User Manual Electrodes connection: Ensure that the electrodes are clean; Align lead wires of patient cable to avoid twisting; Clean electrode area on a short distance with alcohol; Daub the electrode area with gel evenly; Place a small amount of gel on the metal part of electrode clamp;...
  • Page 31 VE-300 Veterinary Electrocardiograph User Manual 4) Electrodes: ♦ Be sure that all electrodes have been connected to the animal correctly. ♦ Ensure that the electrodes do not contacted with each other. 5) Recorder Paper: ♦ Ensure that there is enough recorder paper loaded correctly.

  • Page 32: Operation Instructions

    ( ) is lit. Then press ON/OFF key on the control panel to turn on the unit. Equipment information such as device name and version No. will be displayed on LCD screen after self-test. Then VE-300 is ready for examination and recording.

  • Page 33: Manual Mode

    VE-300 Veterinary Electrocardiograph User Manual Note: In the OFF mode, the sampled ECG waves will not be recorded. The average template and/or measurement information can be recorded according to the settings made by the user. 5.3 MANUAL Mode In the MANUAL mode, users should switch the lead group manually. Users can determine which lead group needs to be recorded and set the record settings or other parameters according to different lead group.

  • Page 34: Usbprt Mode

    5.5 USBPRT mode In the USBPRT mode, ECG report can be printed out through USB printer. 1) Connect VE-300 to the USB printer recommended by EDAN; 2) Press MENU key to enter Menu window to set corresponding options. Press it again to return after setup;...
  • Page 35 VE-300 Veterinary Electrocardiograph User Manual Operation for ECG RECALL: 1) Press RECALL key to enter the Recall Window (a) where patient files are saved; 2) If the user wants to transmit all the files, press Left or Right to choose TRANS ALL, and then press PRINT/STOP or MENU key to transmit all the files;...
  • Page 36 ECGDATA folder of the U disk and in the recall window of the electrocardiograph has exceeded the limit (The limit of VE-300 is 120). If the total number has exceeded the limit, the user should remove some files from the ECGDATA folder of the U disk and then continue to import.

  • Page 37: Ecg Copy

    VE-300 Veterinary Electrocardiograph User Manual WARNING WARNNING WARNING (c) You will delete this file! Are you sure? _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ [RECALL]- >OK...

  • Page 38: Using The Menu System

    VE-300 Veterinary Electrocardiograph User Manual 5.7 Using the Menu System 5.7.1 Entering and Exiting the Menu Press the MENU key to enter the menu, and press the MENU key again to exit the menu. AC Filter : On EMG Filter...

  • Page 39: Record Settings

    VE-300 Veterinary Electrocardiograph User Manual to turn on the function and select Off to turn off. EMG FILTER EMG FILTER suppresses disturbances caused by strong muscle tremor. The cutoff frequency is user-defined at 25Hz, 35Hz or 45Hz. Select Off to turn off the function.

  • Page 40: Record Output Settings

    VE-300 Veterinary Electrocardiograph User Manual RECORD SPEED In the MANUAL/RHYTHM mode, RECORD SPEED can be set as 5, 6.25, 10, 12.5, 25 or 50mm/s. In the AUTO/OFF/USBPRT mode, RECORD SPEED can be set as 25 or 50mm/s. RECORD LENGTH Short form means that each lead group will be recorded about 2.5 seconds.

  • Page 41: Other Record Settings

    VE-300 Veterinary Electrocardiograph User Manual MEASUREMENT When MEASUREMENT is On, the measure information will be recorded when recording in AUTO mode. When MEASUREMENT is Off, there will be no measure information when recording. Note: To get the content of MEASUREMENT, please refer to Chapter 5.9 ECG Record.

  • Page 42: Save And Transmitting Settings

    VE-300 Veterinary Electrocardiograph User Manual PAPER STYLE Rolled thermal paper and folded thermal paper can be selected as record Paper. Note: If the user sets the PAPER STYLE as Folded paper, after ECG recording is completed in Auto mode or RHYTHM mode, recording will stop when a black sign is detected, or it will stop with hint information “Paper Err”...

  • Page 43: General Settings

    EXTERN INP/OUTP External input/output signal interface is equipped in VE-300, through which VE-300 can receive ECG signal from external equipment, or output ECG signal to other external equipment. Set this item as On to turn on the function and Off to turn off.

  • Page 44: System Settings

    VE-300 Veterinary Electrocardiograph User Manual Press Left or Right to start record test when the record paper has been loaded. Then the triangle wave in effective paper width will be recorded. The status of print head can be estimated from this triangle wave. Press Left or Right again to stop record test.

  • Page 45: Default Settings

    VE-300 Veterinary Electrocardiograph User Manual 5.8.8 Default Settings In the following table, the value double-underlined is default setting. Items Options On, Off AC Filter Off, 25Hz, 35Hz, 45Hz EMG Filter 0.05Hz, 0.15Hz, 0.25Hz, 0.5Hz DFT Filter 75Hz, 100Hz, 150Hz Lowpass Filter...
  • Page 46 VE-300 Veterinary Electrocardiograph User Manual Off, Testing Record Test Off, On Demo Setting Chinese, English Language Setting 7 leads, 6 leads Lead Setting Restore Default Setting dd-mm-yyyy, mm-dd-yyyy, yyyy-mm-dd Data Mode 24-12-2007 Date Setting 08 : 23 Time Setting 071224-0823...

  • Page 47: Auto Mode Record

    VE-300 Veterinary Electrocardiograph User Manual 5.9 AUTO mode record Figure (a) shows the following content: 10mm/mV----Sensitivity 0.15~100Hz----Filter information AC50----50Hz AC Filter 08-01-2008 09:49:15----Date and time ----1mV calibration mark I, II, III, aVR, aVL, aVF, V----Lead name ECG wave of 7 leads in the format of 3Ch...
  • Page 48 VE-300 Veterinary Electrocardiograph User Manual VE-300 V1.0----Model of the equipment and version number Figure (b) shows the AVERAGE TEMPLET (2Ch+1R) and the MEASUREMENT (ON). And the items of the MEASUREMENT include: ID, Owner, Name, Type, Age, Sex, BP, Weight, HR (Heart Rate) P Dur----P wave duration: mean of duration of P-wave from several of 12 selected dominant beats;...

  • Page 49: Rhythm Mode Record

    VE-300 Veterinary Electrocardiograph User Manual 5.10 RHYTHM mode record Figure (a) shows the following content: 10mm/mV (Sensitivity) 0.15~100Hz (Filter information) AC50 (50Hz AC Filter) 08-01-2008 09:51:19----Date and time (1mV calibration mark) -44-...
  • Page 50 VE-300 Veterinary Electrocardiograph User Manual II (Lead name） 60 seconds rhythm waveform of lead II 00:00, 00:20, 00:40 (Timer） 60 (Heart rate） 25mm/s (Paper speed） Figure (b) shows RR Analysis Results, including RR Interval measurement information, RR Histogram and RR Trend Chart.

  • Page 51: Usbprt Mode Record

    VE-300 Veterinary Electrocardiograph User Manual 5.11 USBPRT mode record -46-...

  • Page 52: Switch Off

    VE-300 Veterinary Electrocardiograph User Manual As figure above shows, the USBPRT mode record includes: ID, Record speed, Hint information, Sensitivity, Date and time; Owner, Name, Type, Age, Sex, BP, Weight; Heart Rate, P duration, PR interval, QRS duration, QT/QTC interval, P/QRS/T axis;...

  • Page 53: Hint Information

    VE-300 Veterinary Electrocardiograph User Manual 6 Hint Information Hint information will be displayed when there is something wrong. Hint information provided by VE-300 and corresponding cause is listed in Table 6-1. Table 6-1 Hint Information and Causes Hint Information Causes...

  • Page 54: Technical Specifications

    VE-300 Veterinary Electrocardiograph User Manual 7 Technical Specifications Safety IEC 60601-1:1988+A1+A2, EN 60601-1:1990+A1+A2, Standards IEC/EN 60601-1-2:2001+A1, IEC/EN 60601-2-25, ANSI/AAMI EC-11 Classification Class І with internal power supply Anti-electric-shock type: Anti-electric-shock degree: Type CF Degree of protection against harmful Ordinary equipment...
  • Page 55 VE-300 Veterinary Electrocardiograph User Manual Charge voltage (standard) = (17±0.1V) Cycle life ≥ 300 times Power Consumption: 35VA (max) T400mA250V Ø5×20/T200mA 250V Ø5×20 Fuse: Recording Recorder: Thermal dot-matrix printer Folded thermal paper, 80mm width Record Paper: Rolled thermal paper, 80mm width...
  • Page 56 VE-300 Veterinary Electrocardiograph User Manual DFT Filter: 0.05/0.15/0.25/0.5 EMG Filter: 25Hz/35Hz/45Hz/OFF LOWPASS Filter:150Hz/100Hz/75Hz ≥110dB CMRR: Sampling Frequency: 1000Hz <10 µ A (220V~240V) Patient Leakage Current: <0.1 µ A (DC) Patient Auxiliary Current: Dielectric Strength: 4000V rms ≥100k Ω ; Sensitivity 10mm/V±5%;...

  • Page 57: Cleaning, Care And Maintenance

    VE-300 Veterinary Electrocardiograph User Manual 8 Cleaning, Care and Maintenance 8.1 Cleaning CAUTION Turn off the power before cleaning and disinfection. Mains supply must be switch off if it has been in use. 8.1.1 Cleaning the Main Unit and Patient Cable The surfaces of the main unit and patient cable can be wiped with a clean soft cloth damped in soapy water or non-caustic neutral detergent.

  • Page 58: Disinfection

    The battery should be recharged immediately 2) Recharge VE-300 is equipped with recharge control circuit together with built-in rechargeable lithium battery. When connect with the mains supply, the battery will be recharged automatically. And then the battery recharge indicator lamp ( ) and the mains supply indicator lamp ( will be lit at the same time.

  • Page 59: Record Paper

    VE-300 Veterinary Electrocardiograph User Manual usage. Note: If the battery has not been used for two or three months above, recharge should be done before use the battery again. 3) Replacement When the useful life of battery is over, or foul smell and leakage has been found, please contact with manufacturer or local distributor for replacement of battery.
  • Page 60 VE-300 Veterinary Electrocardiograph User Manual a) Inspect the equipment and accessories for mechanical and functional damage. b) Inspect the safety related labels for legibility. c) Inspect the fuse to verify compliance with rated current and breaking characteristics. d) Verify the device functions properly as described in the instructions for use.
  • Page 61 VE-300 Veterinary Electrocardiograph User Manual immediately. 3) Electrodes ♦ Electrodes must be cleansed after use and be sure there is no remainder gel on them. ♦ After long-term use, the surface of electrodes will be oxidized because of erosion and other causes.

  • Page 62: Warranty And Service Policy

    VE-300 Veterinary Electrocardiograph User Manual 9 Warranty and Service Policy 9.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and are free from defects in materials and workmanship that occur within warranty period. The warranty period begins on the date the products are shipped to distributors.
  • Page 63 VE-300 Veterinary Electrocardiograph User Manual Under warranty: the service claimer is responsible for freight & insurance charges when a return is shipped to EDAN for service including custom charges. EDAN is responsible for freight, insurance & custom charges from EDAN to service claimer.

  • Page 64: Accessories

    Flat clip electrode LAUNCH / M15R-040145 Carrying Bag EDAN / MS1-107119-A0 VE-300 and accessories are available by contacting the manufacturer or your local distributor. Manufacturer: EDAN INSTRUMENTS, INC. Address: 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan Shenzhen, 518067 P.R.

  • Page 65: Emc Information - Guidance And Manufacture's Declaration

    Guidance and manufacture’s declaration – electromagnetic emission The VE-300 Veterinary Electrocardiograph is intended for use in the electromagnetic environment specified below. The user of the VE-300 Veterinary Electrocardiograph should assure that it is used in such an environment. Electromagnetic environment – guidance...

  • Page 66: Life-Supporting

    Guidance and manufacture’s declaration – electromagnetic immunity The VE-300 Veterinary Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of VE-300 Veterinary Electrocardiograph should assure that it is used in such an environment. Compliance...
  • Page 67 VE-300 Veterinary Electrocardiograph User Manual Veterinary Electrocardiograph, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance   Conducted RF   IEC 61000-4-6 150 kHz to 80 MHz ...

  • Page 68: Recommended Separation Distances

    RF communications equipment and electrocardiograph The VE-300 Veterinary Electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the VE-300 Veterinary Electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance...
  • Page 69 EDAN INSTRUMENTS, INC. 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan Shenzhen, 518067 P.R. China TEL:86-755-26882220 FAX: ＋86-755-26882223 EC REPRESENTATIVE Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, D-20537 Hamburg Germany TEL: +49-40-2513175 FAX: +49-40-255726 E-mail: antonjin@yahoo.com.cn...

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