EDAN INSTRUMENTS VE-100 User manual

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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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I
About this Manual
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. (hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
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II
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.
NOTE: A NOTE provides useful information regarding a function or a procedure.
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III
Table ofContents
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................................................................................................................6
2.2 List of Symbols ...................................................................................................................7
3 General Information...................................................................................................................9
3.1 Top Panel.............................................................................................................................9
3.1.1 LCD Screen...............................................................................................................9
3.1.2 Controlling Panel and Keys ....................................................................................10
3.2 Patient Cable Socket and Signal Interface ........................................................................14
3.3 Mains Connection and Switch...........................................................................................16
3.4 Bottom Panel.....................................................................................................................17
4 Operation Preparations............................................................................................................18
4.1 Power Supply ....................................................................................................................18
4.2 Loading/Replacing Record Paper......................................................................................19
4.3 Patient Cable Connection..................................................................................................20
4.4 Electrode Connection........................................................................................................21
4.5 Inspection before Switching on.........................................................................................22
5 Operation Instructions..............................................................................................................24
5.1 Switching On.....................................................................................................................24
5.2 Animal Information Input..................................................................................................24
5.3 Menu Settings....................................................................................................................25
5.3.1 Filter Settings ..........................................................................................................26
5.3.2 Recording Settings ..................................................................................................27
5.3.3 Date and Time Settings ...........................................................................................27
5.3.4 Printing Head Test...................................................................................................27
5.3.5 External Input/Output Settings................................................................................28
5.3.6 Key and QRS Beep Settings....................................................................................28
5.3.7 Rhythm Lead Settings.............................................................................................28
5.4 Sensitivity Switching.........................................................................................................28
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IV
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..............................................................36
8.1.2 Cleaning the Electrodes...........................................................................................36
8.1.3 Cleaning the Print Head ..........................................................................................36
8.2 Disinfection.......................................................................................................................37
8.3 Care and Maintenance.......................................................................................................37
8.3.1 Recharge and Replacement of Battery....................................................................37
8.3.2 Record Paper...........................................................................................................38
8.3.3 Maintenance of Main Unit, Patient Cable & Electrodes.........................................39
9 Warranty and Service...............................................................................................................41
9.1 Warranty............................................................................................................................41
9.2 Contact Information ..........................................................................................................41
10Accessories................................................................................................................................42
11 EMC Information....................................................................................................................43
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1 Safety Guidance
In order to use the electrocardiograph safely and effectively, avoiding possible dangers caused
by improper operations, 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.
1.1 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. The
cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart
disease.
1.2 Safety Warnings
WARNING :
♦The electrocardiograph is provided for the use of qualified physicians or
personnel professionally trained. They should be familiar with the contents of
this user manual before operation.
♦Only qualified service engineers can install this equipment, and only service
engineers authorized by EDAN can open the shell.
♦Only qualified installation or service engineers can shift the mains shift switch
(100V~115V/220V~240V) according to local mains supply.
♦The results given by the equipment should be examined with respect to the
overall clinical condition of the animal, and it can not substitute for regular
checking.
WARNING :
♦EXPLOSION HAZARD-Do not use the electrocardiograph in the presence of
flammable anesthetic mixture with oxygen or other flammable agents.
♦SHOCK HAZARD-The power receptacle must be a hospital grade grounded
outlet. Never try to adapt the three-prong plug to fit a two-slot outlet.
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♦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.
♦This equipment is not designed for direct cardiac application.
WARNING :
♦Only patient cable and other accessories supplied by EDAN can be used. Or
else, the performance and electric shock protection can not be guaranteed.
♦Be sure that all electrodes have been connected to the animal correctly before
operation.
♦Ensure that the conductive parts of electrodes and associated connectors,
including neutral electrode, do not come in contact with earth or any other
conducting objects.
♦Electrodes with defibrillation protection should be used while defibrillating.
♦There is no danger for animals with pacemaker.
♦Do not touch the animal, bed, table and the equipment while using defibrillator
or pacemaker simultaneously.
♦In order to avoid burning, please keep the electrode far away from the radio
knife while using electrosurgical equipment simultaneously.
♦If you use electrode gel with reusable electrodes during defibrillation , the ECG
recovery will be greater than 10 seconds. EDAN recommends the use of
disposable electrodes at all times.
WARNING :
♦Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for
data processing equipment and IEC/EN 60601-1 for medical equipment).
Furthermore all configurations shall comply with the valid version of the
standard IEC/EN 60601-1-1. Therefore anybody, who connects additional
equipment to the signal input connector or output connector to configure a
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
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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.
1.3 Battery Care Warnings
WARNING :
♦Improper operation may cause the battery to be hot, ignited or exploded, and it
may lead to the declination of battery’s capacity. It is necessary to read the user
manual carefully and pay more attention to warning messages.
♦Only qualified service engineer authorized by EDAN can open the battery
compartment and replace the battery, and the battery of same model and
specification provided by manufacturer should be used.
♦Danger of explosion -- Do not reverse the anode and cathode when connecting
the battery.
♦Do not heat or splash the battery or throw it into fire or water.
♦When leakage or foul smell is found, stop using the battery immediately. If your
skin or cloth comes into contact with the leakage liquid, cleanse it with clean
water at once. If the leakage liquid splashes into your eyes, do not wipe them.
Irrigate them with clean water first and go to see a doctor immediately.
♦When the battery’s useful life is over, contact the manufacturer or local
distributor for disposal or dispose the battery according to local regulations.
1.4 General Cautions
CAUTION :
♦Avoid liquid splash and excessive temperature. The temperature must be kept
between 5℃and 40℃while working, and it should be kept between -20℃and
55℃during transportation & storage.
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♦.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. are likely to bring
electromagnetic interference.
CAUTION :
♦Before use, the equipment, patient cable and electrodes etc. should be checked.
Replacement should be taken if there is any evident defectiveness or aging
symptom which may impair the safety or performance.
♦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.
a) Inspect the equipment and accessories for mechanical and functional
damage.
b) Inspect the safety relevant 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.
e) Test the protection earth resistance according to IEC/EN 60601-1: Limit
0.2 ohm.
f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC
500 uA, SFC 1000uA.
g) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10
uA (CF).
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.
♦Ruptured fuse must only be replaced with that of the same type and rating as
the original.
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♦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.
♦Federal (US) law restricts this device to sale by or on the order of a
veterinarian.
1.5 Cleaning & Disinfection Cautions
CAUTION :
♦Turn off the power before cleaning and disinfection. If mains supply used, the
power cord should be drugged out of the outlet also. Prevent the detergent from
seeping into the equipment.
♦Do not immerse the unit or patient cable into liquid under any circumstances.
♦Do not clean the unit and accessories with abrasive fabric and avoid scratching
the electrodes.
♦Any remainder of detergent should be removed from the unit and patient cable
after cleaning.
♦Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
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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. Manual recording mode
and three automatic recording modes can be chosen freely. Either mains supply or built-in
rechargeable Lithium battery can be used as power supply.
Configuration: Main unit and accessories, including patient cable, electrodes, thermal
recording paper and power cord etc.
Note: It is not designed for direct cardiac application.
2.1 Function Features
♦Low weight and compact size
♦Touch key for easy operation
♦LCD for single channel ECG preview before recording
♦Three automatic recording modes and manual mode optional
♦General menu for recording parameters setting
♦Built-in rechargeable Lithium battery with high capacity
♦Alarm information for lead off, lack of paper and weak battery etc.
♦Thermal dot-matrix printer for high-resolution printout
♦Automatic adjustment of baseline for optimal recording
♦Selectable printing formats, standard single channel or single channel & rhythm lead
♦Standard external input/output interface and RS232 communication interface
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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
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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; Symbol: White)
Warning
(Background: Yellow; Symbol&Outline: Black)
NOTE: The user manual is printed in black and white.
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3 General Information
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:
♦Operation mode (AUTO1, AUTO2, AUTO3 and MANU)
♦II stop symbol, which will turn to while recording
♦Warning message (LD OFF, or PAPER? etc.)
LCD Screen
Label
Recorder
Control Panel
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♦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)
♦ECG
Fourth Row:
♦Sensitivity (×1, ×2, AGC, ·25, ·5)
♦Paper speed (25, 50)
♦Battery capacity symbol ( ， ， ， )
♦Display the ID, sex (Male/Female) and age group (YOUNG/MATURE/OLD) while
setting; and “BATTERY WEAK” will be showed here when the battery capacity is
weak.
3.1.2 Controlling Panel and Keys
1) Indicator
Mains supply indicator: when mains supply is used, the indicator will be lit.
Battery indicator: when the built-in rechargeable lithium battery is used, the
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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 ON/OFF key being pressed, the battery recharging indicator will be black if
the battery capacity is full. However, if the battery capacity is not full, the battery
recharging indicator will be lit until the battery is full recharged, and after that the
battery recharging indicator will be black.
2) SENS (Sensitivity Switch Key)
The sensitivity switching order: ×1 → ×2 → AGC → · 25 → · 5
The ECG signal range which can be measured and recorded is different according to
different sensitivity, as the following list shows.
Options
Sensitivity
Signal range measured
×1
10mm/mV
-2.5mV ~ +2.5mV
×2
20mm/mV
-1.25mV ~ +1.25mV
AGC
Auto Gain Control
Adjust sensitivity automatically
·25
2.5mm/mV
-10mV ~ +10mV
·5
5mm/mV
-5mV ~ +5mV
If the fluctuating range of the ECG signal is great, „AGC‟would be better to be chosen for
the sensitivity can be adjusted automatically in this mode.
3) RESET (Lead Locking Key)
Press this key to lock the lead while ECG recording. After that, the corresponding ECG
will be a line. It is always used to draw the baseline to zero quickly in the case of baseline
excursion in actual ECG recording. The lead will be unlocked automatically after 0.4
seconds.
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4) 1mV Calibration Key
In the manual mode, this key can be pressed to record a 1mV calibration pulse at any time
while recording.
5) MODE (Mode Switch Key)
There are three automatic modes and a manual mode. This key can be pressed to select
recording mode. The switching order of leads in each mode is listed in Table 3-1.
Table 3-1 Lead Switching Order of Different Mode
Mode
Switching Order (from left to right)
MANU
І
П
Ш
AVR
AVL
AVF
V
AUTO1
І
П
Ш
AVR
AVL
AVF
V
AUTO2
AVL
І
AVR
П
AVF
Ш
V
AUTO3
2 channel automatic mode (AUTO1 + Rhythm Lead)
6) LEAD (Lead Switch Key)
In the manual mode, press the key to switch the lead in order.
7) PRINT/STOP Key
Used to begin recording and stop recording.
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8) ON/OFF Key
When the unit has been powered on, press this key to turn on or turn off the
electrocardiograph.
9) MENU Key
Press MENU key to enter menu settings interface.
10) ID Setting Key
These two ID keys can be pressed to set the animal‟s ID number. Press the upward arrow
key to increase ID number while press the downward arrow key to decrease ID number on
the basis of current ID number.
11) M/F
Press M/F key to choose sex, male (M) or female (F).
12) AGE
Press AGE key to choose age: YOUNG, MATURE or OLD.
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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.
1) Patient Cable Socket
Definition of corresponding pins:
Pin
Signal
Pin
Signal
Pin
Signal
1
NC
6
SH
11
F/LL (input)
2
NC
7
NC
12
NC
3
NC
8
NC
13
C /V(input)
4
NC
9
R /RA(input)
14
NC
5
NC
10
L /LA(input)
15
N or RF /RL(input)
Note: The left side of “/” is European standard; and the right side is American standard.
2) RS232 Socket
WARNING :
RS232 interface is 1500V AC isolated intensity and the maximum voltage applied
should not exceed +15V DC.
Patient cable socket
RS232 socket
External Input/Output socket
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