EDAN VE-H100B User manual

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EDAN CONFIDENTIAL

I
About this Manual
P/N: 01.54.110263
MPN: 01.54.110263018
Release Date: September 2016
© Copyright EDAN INSTRUMENTS, INC. 2009-2016. 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) cannot 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.
MS1R-109000-V1.21
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II
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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III
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.
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IV
Table of Contents
1 Safety Information................................................................... 1
1.1 Warnings............................................................................ 1
1.2 Cautions............................................................................ 11
1.3 Notes ................................................................................ 12
1.4 Symbols in the Oximeter.................................................. 15
2 Introduction............................................................................ 18
2.1 General Introduction......................................................... 18
2.2 Panel Introduction ............................................................ 19
2.2.1 Symbols on Screen.................................................... 20
2.2.2 Front Panel Buttons .................................................. 22
2.2.3 Rear Panel................................................................. 26
2.3 Connecting Sensor or Cable............................................. 26
2.4 Powered by Battery .......................................................... 28
2.5 Accessory List.................................................................. 31
3 Oximeter Operation............................................................... 33
3.1 Turning on the Oximeter .................................................. 33
3.2 Measurement State........................................................... 34
3.2.1 Measurement Modes................................................. 34
3.2.2 Trend Graph and Trend Table................................... 35
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3.2.3 Abnormal Measurement State................................... 36
3.2.4 Data Transfer State ................................................... 37
3.3 System Menu.................................................................... 37
3.3.1 System Mode ............................................................ 40
3.3.2 Model........................................................................ 40
3.3.3 Alarm Volume .......................................................... 40
3.3.4 Pulse Volume............................................................ 40
3.3.5 Audio Paused (s)....................................................... 41
3.3.6 User Maintain ........................................................... 41
3.3.7 Default Config .......................................................... 42
3.3.8 Sensitivity................................................................. 43
3.3.9 Alarm System ........................................................... 44
3.3.10 SpO2Alarm Setup................................................... 45
3.3.11 PR Alarm Setup ...................................................... 46
3.3.12 Patient ID No. Setup ............................................... 47
3.3.13 Data Storage............................................................ 48
3.3.14 Delete All Data ....................................................... 49
3.3.15 Exit (Return)........................................................... 49
3.4 Charging the Ni-MH Battery Package.............................. 50
3.5 Oximeter Viewer Data Management Software Introduction
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VI
............................................................................................... 51
4 Sensor Operation ................................................................... 54
5 Alarm ...................................................................................... 57
5.1 Alarm Categories and Levels ........................................... 57
5.2 Alarm Conditions............................................................. 59
5.2.1 Alarm off Before the First Measurement.................. 59
5.2.2 Alarm for SpO2Sensor Unconnected ....................... 59
5.2.3 Alarm for SpO2Sensor off........................................ 60
5.2.4 Alarm for Low Battery.............................................. 60
5.2.5 Higher than Hi Alarm Limit...................................... 60
5.2.6 Lower than Lo Alarm Limit...................................... 61
5.2.7 Alarm Silence ........................................................... 61
5.2.8 Turning off Alarm System........................................ 61
5.2.9 Alarm Priority........................................................... 62
5.2.10 Alarm Delay............................................................ 62
5.2.11 Testing Alarms........................................................ 63
6 Performance Considerations................................................. 64
6.1 Performance Verification ................................................. 64
6.2 Oximeter Performance Considerations............................. 64
6.3 Sensor Performance Considerations................................. 65
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VII
6.4 SpO2Functional Test........................................................ 67
6.5 Assessing the Validity of a SpO2Reading........................ 68
7 Maintenance........................................................................... 69
8 Principles of Operation.......................................................... 75
8.1 Pulse Oximetry Measurement .......................................... 75
8.2 Functional Versus Fractional Saturation........................... 77
8.3 Measured Versus Calculated Saturation........................... 78
9 Warranty and Service............................................................ 79
9.1 Warranty........................................................................... 79
9.2 Contact information.......................................................... 80
Appendix I Specification .......................................................... 81
A1.1 Classification................................................................. 81
A1.2 Specification.................................................................. 81
A1.2.1 Size and Weight..................................................... 81
A1.2.2 Environment........................................................... 81
A1.2.3 Display................................................................... 82
A1.2.4 Batteries................................................................. 82
A1.2.5 Charger Stand ........................................................ 84
A1.3 Parameters..................................................................... 84
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VIII
Appendix II EMC Information................................................ 86
A2.1 Electromagnetic Emissions............................................ 86
A2.2 Electromagnetic Immunity ............................................ 87
A2.3 Electromagnetic emissions ............................................ 93
A2.4 Recommended Separation Distances............................. 97
Appendix III Record Table....................................................... 99
Appendix IVAbbreviations.................................................... 100
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VE-H100B Veterinary Pulse Oximeter User Manual
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1 Safety Information
1.1 Warnings
Warnings are identified by the WARNING symbol shown
above.
A WARNING label advises against certain actions or
situations that could result in personal injury or death.
WARNING
1 Avoid the explosion hazard. Do not use the VE-H100B
Veterinary Pulse Oximeter (hereinafter called oximeter)
in the presence of flammable Anesthetics mixture with
air, oxygen, or nitrous oxide.
2 Chemicals from a broken LCD display panel are toxic
when ingested. Use cautions when the oximeter has a
broken display panel.
3 Routinely monitor the patient to make sure the oximeter
is functioning and the sensor is correctly placed.
4 Oximetry measurements and pulse signals can be
affected by certain environmental conditions, sensor
application errors, and certain patient conditions.
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WARNING
5 The use of accessories, sensors, and cables other than
those specified may result in increased emission of
electromagnetic radiation and/or invalid readings of the
oximeter.
6 Do not silence the audio alarm function, or decrease
the audio alarm volume, if patient safety could be
compromised.
7 The oximeter is a prescription device to be operated
only by trained personnel. The oximeter is for attended
monitoring only.
8 The oximeter is not defibrillator-proof. The
measurements may be inaccurate throughout the
defibrillation, or use of an electrosurgical unit, and shortly
thereafter. To avoid shock, the caregiver should not hold
the oximeter while using a defibrillator on a patient.
9 The use of patient cable and other accessories not
supplied by the manufacturer may result in increased
emissions or decreased immunity of the equipment.
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WARNING
10 Disconnect the oximeter and sensor from the patient
throughout magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause
burns.
11 To ensure accurate performance and prevent device
failure, do not subject the oximeter to extreme moisture,
such as direct exposure to rain. Such exposure may
cause inaccurate performance or device failure.
12 Do not lift the oximeter by the sensor or extension cable
because the cable could disconnect from the oximeter
and the oximeter may drop on the patient.
13 Do not make any clinical judgment based solely on the
oximeter. It is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical
signs and symptoms.
14 To ensure patient safety, do not place the oximeter in
any position that might cause it to fall on the patient.
15 As with all medical equipment, carefully route patient
cables to reduce the possibility of patient entanglement
or strangulation.
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WARNING
16 Ensure that the speaker is clear of any obstruction and
that the speaker holes are not covered. Failure of doing
so could result in an inaudible alarm tone.
17 Use only EDAN permitted sensors and extension cables
with the oximeter. Other sensors or extension cables
may be failed or cause improper monitor performance.
18 Oximeter readings and pulse signals can be affected by
certain ambient environmental conditions, sensor
application error, and certain patient conditions. See
the appropriate sections of the manual for specific
safety information.
19 Don’t mix new and old batteries together. Don’t mix
rechargeable batteries with alkaline batteries.
20 Periodically check the battery for corrosion. Take out
the batteries from the oximeter if you do not expect to
use it within one month.
21 The medical electrical equipment needs special
precautions regarding EMC and needs to be installed
and put into service according to the EMC Information
provided in this user manual.
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WARNING
22 The device enters POST (Power-On-Self-Test)
immediately after power-on to confirm all the display
segments and icons are shown and the speaker
sounds a few seconds tone. If you do not hear the
POST pass tone, it indicates the alarm system does not
work well. Please do not use the oximeter and contact
qualified service personnel or your local EDAN
representative.
23 Before using it, the user should carefully read the
applicable user manual of sensor, including warnings,
cautions and instructions.
24 Do not use damaged sensor or extension cables, do
not use sensor with exposed optical components.
25 Tissue damage may be caused by incorrect application
or prolonged measurement duration using the sensor
(more than 2 hours). Inspect the sensor periodically
according to sensor user manual.
26 Do not immerse or wet the sensor, as this may damage
the sensor.
27 This equipment is not intended for home usage.
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WARNING
28 There are no user-serviceable parts inside the oximeter,
the cover should only be removed by qualified service
personnel.
29 Do not spray, pour, spill liquid to the oximeter and its
accessories, connector, switch or opening in enclosure,
as this may damage the oximeter.
30 Before cleaning the oximeter or the sensor, make sure
that the equipment is switched off and disconnected
from the power line.
31 Reusable sensors must be moved to a new site at least
every 4 hours. Because individual skin condition affects
the ability of the skin to tolerate sensor placement. It
may be necessary to change the sensor site more
frequently with some patients. If skin integrity changes,
move the sensor to another site.
32 Do not use supplemental tape to adhere the clip and
sensor directly to the site, this can restrict blood flow
and cause inaccurate measurements.
33 Intravascular dyes may lead to inaccurate
measurements.
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WARNING
34 Performance of the sensor may be compromised by
motion, particularly of a repetitive nature. If readings
cannot be obtained, try another application site.
35 Do not alter or modify the sensor. Alterations or
modifications may affect performance or accuracy.
36 Failure of applying the sensor properly may cause
incorrect measurements.
37 Using the sensor in the presence of bright lights may
result in inaccurate measurements. In such case, cover
the sensor with an opaque material.
38 Do not service or maintain the oximeter or any
accessory which is in use with the patient.
39 Incorrect replacement of batteries would result in
unacceptable risk. The batteries shall be replaced by
adequately trained personnel.
40 The oximeter should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is
necessary, you must check that normal operation is
possible in the necessary configuration before you start
monitoring patients.
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WARNING
41 Portable and mobile RF communications equipment
can affect medical electrical equipment; refer to the
recommended separation distances provided in
Appendix A2 EMC Information.
42 Operation of the equipment exceeding specified
physiological signal or the operational specification
may cause inaccurate results.
43 Only use EDAN approved rechargeable batteries and
charger stand for the oximeter.
44 Do not place battery in the oximeter with the (+) and (-)
in the wrong way.
45 Setting alarm limits to extreme values may cause the
alarm system to become ineffective. It is recommended
to use the default settings.
46 Do not touch accessible parts of electrical equipment in
the patient environment and the patient simultaneously.
47 Without use of data store function, the data previously
measured will be cleared when the oximeter is powered
off. With use of data store function, 300-hour SpO2&PR
data can be stored and transmitted to the computer.
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WARNING
48 Please avoid inhalation or swallowing of small parts.
49 A potential hazard can exist if different alarm presets
are used for the same or similar equipment in any
single area, e.g. an intensive care unit or cardiac
operating room.
50 Do not touch accessible parts of non-medical electrical
equipment and the patient simultaneously. Do not touch
the signal input or output connector and the patient
simultaneously.
51 The simultaneous use of cardiac pacemaker may
cause safety hazard.
52 During monitoring, if the power supply is off, the
oximeter will be off, and only the patient information
and alarm settings can be saved. After reconnecting
the power supply, the user should turn on the oximeter
for monitoring.
53 If several medical equipments are connected to a patient,
the sum of the leakage currents shouldn’t exceed the
limits, otherwise it may cause shock hazard.
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WARNING
54 Before using the device, the equipment, patient cable
and sensors etc. should be checked. Replacement
shall be taken if there is any evident defect or signs of
aging which may impair the safety or performance.
55 The device should keep away from pets, pests or
children.
56 No modification of this equipment is allowed without
authorization of the manufacturer. If this equipment is
modified, appropriate inspection and testing must be
conducted to ensure continued safe operation.
57 Prolonged and continuous monitoring may increase the
risk of unexpected change of dermal condition such as
abnormal sensitivity, rubescence, vesicle, repressive
putrescence, and so on. It is especially important to
check the sensor placement of neonate and patient of
poor perfusion or immature dermogram by light
collimation and proper attaching strictly according to
changes of the skin. More frequent examinations may
be required for different patients.
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VE-H100B Veterinary Pulse Oximeter User Manual
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1.2 Cautions
Cautions are identified by the CAUTION symbol shown
above.
Cautions alert the user to exercise care necessary for the
safe and effective use of the oximeter.
CAUTION
1 All combinations of equipment must be in compliance
with IEC/EN Standard 60601-1 systems requirements.
2 Batteries are hazardous waste. Do NOT dispose them
together with house-hold garbage. At the end of their
life hand the batteries over to the applicable collection
points for the recycling of waste batteries. For more
detailed information about recycling of this product or
battery, please contact your local Civic Office, or the
shop where you purchased the product.
3 The sensor unconnected icon and associated alarm
indicate the sensor has disconnected or wire fault. So
check the sensor connection and, if necessary, replace
the sensor, extension cables or both.
4 When adjusting any menu parameters, the oximeter
does not display SpO2or PR, but it is still recording.
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