EDAN H100B Manual de usuario
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About this Manual
P/N: 21.54.109000-15
Release Date: Dec 2010
© Copyright EDAN INSTRUMENTS, INC. 2007-2010.
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
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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.
Upon request, EDAN may provide, with compensation,
necessary circuit diagrams, and other information to help
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qualified technician to maintain and repair some parts,
which EDAN may define as user serviceable.
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.
IV
Table of Contents
1 Safety Information .................................................1
1.1 Warnings...........................................................1
1.2 Cautions............................................................7
1.3 Notes.................................................................9
1.4 Symbols in the Oximeter.................................11
2 Introduction..........................................................14
2.1 General Introduction........................................14
2.2 Panel Introduction...........................................15
2.2.1 Symbols on Screen..................................16
2.2.2 Front Panel Buttons..................................18
2.2.3 Rear Panel ...............................................22
2.3 Connecting Sensor or Cable...........................23
2.4 Powered by Battery.........................................24
2.5 Accessory List.................................................27
3 Oximeter Operation .............................................31
3.1 Turning on the Oximeter .................................31
3.2 Measurement State.........................................32
3.2.1 Measurement Modes................................32
3.2.2 Trend Graph and Trend Table .................33
3.2.3 Abnormal Measurement State .................34
3.2.4 Data Transfer State..................................35
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3.3 System Menu..................................................36
3.3.1 System Mode ...........................................38
3.3.2 Patient Type.............................................39
3.3.3 Alarm Volume...........................................39
3.3.4 Pulse Volume...........................................39
3.3.5 Audio Paused (s)......................................40
3.3.6 User Maintain...........................................40
3.3.7 Default Config...........................................41
3.3.8 Sensitivity.................................................42
3.3.9 Alarm System...........................................42
3.3.10 SpO2Alarm setup...................................44
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)...........................................50
3.4 Charging the Ni-MH Battery Package.............50
3.5 PatientCare Viewer Data Management Software
Introduction ...........................................................51
4 Alarm.....................................................................52
4.1 Alarm Categories and Levels..........................52
4.2 Alarm Conditions.............................................54
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4.2.1 Alarm off Before the First Measurement..54
4.2.2 Alarm for SpO2 Sensor Unconnected......55
4.2.3 Alarm for SpO2 Sensor off.......................55
4.2.4 Alarm for Low Battery...............................55
4.2.5 Higher than Hi Alarm Limit.......................56
4.2.6 Lower than Lo Alarm Limit .......................56
4.2.7 Alarm Silence...........................................57
4.2.8 Turning off Alarm System.........................57
4.2.9 Alarm Priority............................................57
5 Performance Considerations..............................58
5.1 Performance Verification.................................58
5.2 Oximeter Performance Considerations...........58
5.3 Sensor Performance Considerations..............59
6 Maintenance .........................................................63
7 Principles of Operation .......................................66
7.1 Pulse Oximetry Measurement.........................67
7.2 Functional Versus Fractional Saturation.........69
7.3 Measured Versus Calculated Saturation ........70
8 Warranty and Service Policy...............................71
8.1 Warranty..........................................................71
8.2 Service Policy..................................................72
AppendixⅠSpecification........................................74
VII
A1.1 Classification.................................................74
A1.2 Specification .................................................74
A1.2.1 Size and Weight.....................................74
A1.2.2 Environment...........................................74
A1.2.3 Display ...................................................75
A1.2.4 Batteries.................................................75
A1.2.5 Charger Stand........................................76
A1.3 Parameters...................................................76
Appendix II EMC Information.................................78
A2.1 Electromagnetic Emissions - for all
EQUIPMENT and SYSTEMS................................78
A2.2 Electromagnetic Immunity - for all
EQUIPMENT and SYSTEMS................................80
A2.3 Electromagnetic emissions-for EQUIPMENT
and SYSTEMS that are not LIFE-SUPPORTING.83
A2.4 Recommended Separation Distances..........87
Appendix ⅢRecord Table....................................89
Appendix ⅣAbbreviations ..................................90
H100B Pulse Oximeter User Manual
- 1 -
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 explosion hazard. Do not use the
oximeter in the presence of flammable
anesthetic mixtures with air, or with 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,
H100B Pulse Oximeter User Manual
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sensor application errors, and certain patient
conditions.
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 Failure to cover the sensor site with opaque
material in high ambient light conditions may
result in inaccurate measurements.
7 Do not silence the audio alarm function, or
decrease the audio alarm volume, if patient
safety could be compromised.
8 The oximeter is a prescription device to be
operated only by trained personnel. The
oximeter is for attended monitoring only.
9 Dispose of batteries in accordance with local
ordinances and regulations.
10 The oximeter is not defibrillator-proof. However,
it may remain attached to the patient throughout
defibrillation or while an electrosurgical unit is in
use. The measurements may be inaccurate
throughout the defibrillation, or use of an
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