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EDAN Agile PLM Electronic Signature Information
--Signatures related to this document and performed in EDAN Agile PLM.
文件名称：VE-100说明书_英文
文件编号：01.54.107118
版本：1.4
产品型号：VE-100
项目编码：2089C000
签批信息:
作者 : 肖 丽军 (xiaolijun)
2016-10-17 17:00:04
审核人 : 董 宁 (dongning)
2016-10-19 08:54:05
审核人 : 肖 文聪 (xiaowencong)
2016-10-17 17:07:24
批准人 : 王 力维 (wangliwei)
2016-10-20 19:50:24
批准人 : 杨 洁 (yangjie)
2016-10-20 14:48:18
版权©深圳市理邦精密仪器股份有限公司
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Table of Contents
Related Manuals for EDAN INSTRUMENTS VE-100
Summary of Contents for EDAN INSTRUMENTS VE-100
- Page 1 EDAN Agile PLM Electronic Signature Information --Signatures related to this document and performed in EDAN Agile PLM. 文件名称：VE-100说明书_英文 文件编号：01.54.107118 版本：1.4 产品型号：VE-100 项目编码：2089C000 签批信息: 作者 : 肖 丽军 (xiaolijun) 2016-10-17 17:00:04 审核人 : 董 宁 (dongning) 2016-10-19 08:54:05 审核人 : 肖 文聪 (xiaowencong) 2016-10-17 17:07:24 批准人...
- Page 3 P/N: 01.54.107118 MPN: 01.54.107118014 Release Date: Oct. 2016 © Copyright EDAN INSTRUMENTS, INC. 2008-2016. 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 4 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.
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Page 5: Table Of Contents
Table of Contents 1 Safety Guidance ........................... 1 1.1 Indications for use/Intended use ..................1 1.2 Safety Warnings ........................1 1.3 Battery Care Warnings ......................3 1.4 General Cautions ......................... 3 1.5 Cleaning & Disinfection Cautions ..................5 2 Introduction ..........................6 2.1 Function Features ........................ - Page 6 5.5 Automatic Mode Operation ....................29 5.6 Manual Mode ........................30 5.7 ECG Record ........................30 5.8 Switch Off ......................... 31 6 Hint Information ........................32 7 Technical Specifications ......................33 8 Cleaning, Care and Maintenance .................... 36 8.1 Cleaning ..........................36 8.1.1 Cleaning the Main Unit and Patient Cable ..............
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Page 7: Safety Guidance
Please pay more attention to the following warning and caution information. 1.1 Indications for use/Intended use The intended use of VE-100 Veterinary Electrocardiograph is to acquire ECG signals from animals through body surface with ECG electrodes. The VE-100 Veterinary Electrocardiograph is only intended to be used in animal hospitals or animal clinics by veterinarians. - Page 8 VE-100 Veterinary Electrocardiograph User Manual ♦ 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. ♦ Do not use this equipment in the presence of high static electricity or high voltage equipment which may generate sparks.
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Page 9: Battery Care Warnings
VE-100 Veterinary Electrocardiograph User Manual technical service department or your local distributor. ♦ The summation of leakage current should never exceed leakage current limits while several other units are used at the same time. ♦ The potential equalization conductor can be connected to that of other equipment when necessary, to make sure that all these equipment are connected with the potential equalization bus bar of the electrical installation. - Page 10 VE-100 Veterinary Electrocardiograph User Manual ♦ .Do not use the equipment in dusty environment with bad ventilation or in the presence of corrosive. ♦ Be sure that there is no intense electromagnetic interference source around the equipment, such as radio transmitter or mobile phone etc. Attention: large medical electrical equipment such as electrosurgical equipment, radiological equipment and magnetic resonance imaging equipment etc.
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Page 11: Cleaning & Disinfection Cautions
VE-100 Veterinary Electrocardiograph User Manual ♦ The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. ♦... -
Page 12: Introduction
VE-100 Veterinary Electrocardiograph User Manual 2 Introduction VE-100 veterinary electrocardiograph is a single channel digital ECG (electrocardiograph) recorder with high performance. One channel cardiogram can be previewed on the LCD (liquid crystal display) screen, and it can be recorded by a high-quality thermal recorder. Moreover, real-time heart rate can be displayed on the screen which can also be printed out on the record. -
Page 13: List Of Symbols
VE-100 Veterinary Electrocardiograph User Manual 2.2 List of Symbols Symbol Description External output External input Defibrillation-Proof Type CF Applied Part Caution Operating instructions Equipotential grounding Mains supply (or indicator) On (mains supply) Off (mains supply) Battery indicator Battery recharging indicator... - Page 14 VE-100 Veterinary Electrocardiograph User Manual General symbol for recovery/recyclable Part Number Serial Number Date of Manufacture Manufacturer Authorized Representative in the European Community CE Marking Disposal method Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician Refer to User Manual (Background: Blue;...
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Page 15: General Information
VE-100 Veterinary Electrocardiograph User Manual 3 General Information Label LCD Screen Recorder Control Panel Figure 3-1 Main Unit 3.1 Top Panel 3.1.1 LCD Screen Normally, the contents displayed on the LCD screen include: (described from left to right in row order) First Row: ♦... -
Page 16: Controlling Panel And Keys
VE-100 Veterinary Electrocardiograph User Manual ♦ Current time Second Row: ♦ Current lead (І, П, Ш, AVR, AVL, AVF, V) ♦ Heart rate (--, actual heart rate, or OVR message) Third Row: ♦ Filter setting (FLT = AC, ALL, OFF, EMG) ♦... - Page 17 VE-100 Veterinary Electrocardiograph User Manual indicator will be lit. Battery recharging indicator: both the battery recharging indicator and mains supply indicator will be lit after the mains power switch has been turned on. After key being pressed, the battery recharging indicator will be black if ON/OFF the battery capacity is full.
- Page 18 VE-100 Veterinary Electrocardiograph User Manual Calibration Key In the manual mode, this key can be pressed to record a 1mV calibration pulse at any time while recording. (Mode Switch Key) MODE There are three automatic modes and a manual mode. This key can be pressed to select recording mode.
- Page 19 VE-100 Veterinary Electrocardiograph User Manual ON/OFF When the unit has been powered on, press this key to turn on or turn off the electrocardiograph. MENU Press MENU key to enter menu settings interface. Setting Key keys can be pressed to set the animal‟s ID number. Press the upward arrow...
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Page 20: Patient Cable Socket And Signal Interface
VE-100 Veterinary Electrocardiograph User Manual 3.2 Patient Cable Socket and Signal Interface There are sockets including the patient cable socket, RS232 socket and external input/output socket at the right side of the main unit as the following Figure shows. Patient cable socket... - Page 21 VE-100 Veterinary Electrocardiograph User Manual Definition of corresponding pins: Signal Signal Signal RxD (input) TxD (output) 3) External Input/Output Socket Definition of corresponding pins: Signal Signal ECG Signal (input) ECG Signal (output) WARNING ♦ Accessory equipment connected to the interfaces must be certified according to the respective IEC/EN standards (e.g.
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Page 22: Mains Connection And Switch
VE-100 Veterinary Electrocardiograph User Manual 3.3 Mains Connection and Switch Potential Mains Power Switch Equalization Conductor Mains Supply Socket At the left side of the main unit, there is the mains supply socket, power switch and potential equalization conductor as the above figure shows. -
Page 23: Bottom Panel
VE-100 Veterinary Electrocardiograph User Manual 3.4 Bottom Panel Mains Supply Shift Switch Fuse Fuse Battery Compartment Fuse Label Label 1) Battery Compartment The battery label indicates the rated voltage and rated capacity of rechargeable Lithium battery pack. Rated voltage: 14.8V, Rated capacity: 2500mAh... -
Page 24: Operation Preparations
VE-100 Veterinary Electrocardiograph User Manual 4 Operation Preparations CAUTION : Before use, the equipment, patient cable，electrodes and other accessories 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 25: Loading/Replacing Record Paper
VE-100 Veterinary Electrocardiograph User Manual the alarm information “BATTERY WEAK” are displayed, which means the battery capacity is weak, please recharge the battery first. Note: Please refer to the maintenance section for how to recharge the battery. During recharging the battery, the electrocardiograph can be powered by mains supply. -
Page 26: Patient Cable Connection
VE-100 Veterinary Electrocardiograph User Manual Pull about 2cm of the paper out, and put down the recorder casing with the paper‟s side edges in parallel with the scale on the surface of casing; Secure the casing by pressing it firmly. -
Page 27: Electrode Connection
VE-100 Veterinary Electrocardiograph User Manual 4.4 Electrode Connection Connecting to a Lead Wire 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. -
Page 28: Inspection Before Switching On
VE-100 Veterinary Electrocardiograph User Manual Electrode 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 29 VE-100 Veterinary Electrocardiograph User Manual 2) Power Supply: ♦ If mains power is used, please check whether the power cord has been connected to the unit well, and the grounded three-phase outlet should be used. ♦ Recharge the battery first before use when the battery capacity is weak.
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Page 30: Operation Instructions
VE-100 Veterinary Electrocardiograph User Manual 5 Operation Instructions 5.1 Switching On ♦ While mains supply used, press the power switch on the left side of the unit first, and the mains supply indicator ( ) is lit. Then press key on the control panel to turn on ON/OFF the unit. -
Page 31: Menu Settings
VE-100 Veterinary Electrocardiograph User Manual Press key to set the sex: female or male, which will be displayed for one or two seconds in the last row on LCD screen. Animals are divided into three groups based on age: YOUNG, MATURE, OLD. Press key to set the age group, which will be displayed for one or two seconds in the right down corner of LCD screen. -
Page 32: Filter Settings
VE-100 Veterinary Electrocardiograph User Manual QRS BEEP ON, OFF І, П, Ш, AVR, AVL, AVF, V RHYTHM LEAD LOWPASS FILTER OFF, 75HZ, 100HZ, 150HZ LANGUAGE ENG, CHN Setting Method: 1) Press key to enter menu settings displayed as the following figure;... -
Page 33: Recording Settings
VE-100 Veterinary Electrocardiograph User Manual 5.3.2 Recording Settings Recording settings includes start, length, count unit, speed and contents. Such as: PWAVE START : ON RECORD LENGTH RECORD COUNT : SECOND RECORD SPEED : 25 HEARTRATE PRINT : ON Take the above settings as example, the ECG will be recorded from P wave, and the printing speed is 25mm/s. -
Page 34: External Input/Output Settings
VE-100 Veterinary Electrocardiograph User Manual 5.3.5 External Input/Output Settings External input/output signal interface is equipped in the electrocardiograph, through which ECG signal from external equipment can be received, and ECG signal detected by the electrocardiograph can be transmitted to other external equipment. Set the EXTINPUT RECORD as ON to turn on the function and OFF to turn off. -
Page 35: Automatic Mode Operation
VE-100 Veterinary Electrocardiograph User Manual 5.5 Automatic Mode Operation Three automatic recording modes are provided by this electrocardiograph, AUTO 1, AUTO 2 and AUTO 3. Two channels, including a rhythm lead, can be recorded together in the AUTO 3 mode. The lead switching orders in the different modes are listed in Table 3-1 in Section 3.1.2. -
Page 36: Manual Mode
VE-100 Veterinary Electrocardiograph User Manual 5.6 Manual Mode In the manual mode, users can determine the lead to be recorded and set the record settings or other parameters according to different leads. Operation Procedures: 1) Press key to choose MANU mode, which can be discerned by the identifier on MODE the left corner of LCD screen as MANU;... -
Page 37: Switch Off
VE-100 Veterinary Electrocardiograph User Manual 5.8 Switch Off When built-in battery pack used, press key directly to turn off the unit after finishing ON/OFF ECG record. When mains supply used, press key first after finishing ECG record and then switch ON/OFF off the mains supply by pressing the switch on the left side of the unit. -
Page 38: Hint Information
VE-100 Veterinary Electrocardiograph User Manual 6 Hint Information Hint information will be displayed on the LCD screen when there is something wrong. Alarm information provided by the electrocardiograph and corresponding cause is listed in Table 6-1. Table 6-1 Hint Information and Causes... -
Page 39: Technical Specifications
VE-100 Veterinary Electrocardiograph User Manual 7 Technical Specifications IEC 60601-1:2005/A1:2012 EN 60601-1:2006/A1:2013 Safety Standards IEC 60601-1-2:2007 EN 60601-1-2:2007/AC:2010 IEC 60601-2-25:2011 Class І with internal power supply Anti-electric-shock type: Anti-electric-shock degree: Type CF with defibrillation proof Degree protection against Ordinary equipment (Sealed... - Page 40 VE-100 Veterinary Electrocardiograph User Manual Pack Rated capacity = 2500mAh Charge mode: Constant current/voltage Charge current (standard) = 0.2C A (320mA) Charge voltage (standard) = (16.8± 0.1V) Cycle life ≥ 300 times Power Consumption 35VA AC220V-240V: T200mA, Φ5×20 Fuse AC100V-115V: T400mA, Φ5×20...
- Page 41 VE-100 Veterinary Electrocardiograph User Manual ≥10M Input Impedance: ≤50nA Input Circuit Current: Input Voltage Range <± 5 mVpp Calibration Voltage: 1mV± 3% <15 Vp-p Noise: EMG Filter: 35Hz (-3dB) Filter AC/DFT Filter: 50Hz/60Hz (-20dB) CMRR >90dB; >100dB (with AC filter) ...
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Page 42: Cleaning, Care And Maintenance
VE-100 Veterinary Electrocardiograph User Manual 8 Cleaning, Care and Maintenance 8.1 Cleaning CAUTION : Turn off the power before cleaning and disinfection. If mains supply used, the unit should be switched off first and the power cord should be plugged out of the outlet. -
Page 43: Disinfection
VE-100 Veterinary Electrocardiograph User Manual 8.2 Disinfection To avoid permanent damage to the equipment, disinfection can be performed only when it has been considered as necessary according to your hospital‟s regulations. Before disinfection clean the equipment first. Then wipe the surface of the unit and patient cable with 70% isopropyl alcohol. -
Page 44: Record Paper
VE-100 Veterinary Electrocardiograph User Manual 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. WARNING ♦ Only qualified service engineer authorized by EDAN can open the battery compartment and replace the battery. -
Page 45: Maintenance Of Main Unit, Patient Cable & Electrodes
VE-100 Veterinary Electrocardiograph User Manual 8.3.3 Maintenance of Main Unit, Patient Cable & Electrodes The following safety checks should be performed at least every 24 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests. - Page 46 VE-100 Veterinary Electrocardiograph User Manual cable. ♦ Align the patient cable to avoid twisting, knotting or crooking in closed angle while using. ♦ Store the lead wires in a bigger wheel. ♦ Once damage or aging of the patient cable has been found, replace it with a new one immediately.
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Page 47: Warranty And Service
VE-100 Veterinary Electrocardiograph User Manual 9 Warranty and Service 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 48: Accessories
VE-100 Veterinary Electrocardiograph User Manual 10 Accessories The accompanying accessories of the electrocardiograph are listed in Table 10-1. Table 10-1 Accessories List Accessory Part Number Power cord 01.13.036638 01.13.109826 (IEC) Patient cable 01.13.109827 (AHA) Alligator clip electrode 01.57.471041 Paper roller 01.51.19992... -
Page 49: Emc Information
VE-100 Veterinary Electrocardiograph User Manual 11 EMC Information Electromagnetic Emissions Guidance and manufacture’s declaration – electromagnetic emission The Electrocardiograph is intended for use in the electromagnetic environment specified below. The user of the Electrocardiograph should assure that it is used in such an environment. - Page 50 VE-100 Veterinary Electrocardiograph User Manual 1 kV line to line 1 kV line to line Surge Mains power quality 2 kV line to ground 2 kV line to ground IEC 61000-4-5 should be that of a typical commercial or hospital environment.
- Page 51 VE-100 Veterinary Electrocardiograph User Manual Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity The Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of Electrocardiograph should assure that it is used in such an environment.
- Page 52 VE-100 Veterinary Electrocardiograph User Manual environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Electrocardiograph is used exceeds the applicable RF compliance level above, the Electrocardiograph should be observed to verify normal operation.
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