EDAN H100B User manual

I
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

II
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

III
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

V
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

VI
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
- 2 -
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

H100B Pulse Oximeter User Manual
- 3 -
electrosurgical unit, and shortly thereafter. To
avoid shock, the caregiver should not hold the
oximeter while using a defibrillator on a patient.
11 Disconnect the oximeter and sensor from the
patient throughout magnetic resonance imaging
(MRI) scanning. Induced current could
potentially cause burns.
12 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.
13 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.
14 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.
15 To ensure patient safety, do not place the
oximeter in any position that might cause it to

H100B Pulse Oximeter User Manual
- 4 -
fall on the patient.
16 As with all medical equipment, carefully route
patient cables to reduce the possibility of
patient entanglement or strangulation.
17 Ensure that the speaker is clear of any
obstruction and that the speaker holes are not
covered. Failure to do so could result in an
inaudible alarm tone.
18 Use only EDAN permitted sensors and
extension cables with the oximeter. Other
sensors or extension cables may fail and/or
cause improper monitor performance and/or
minor personal injury.
19 H100B Pulse 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.
20 Don’t mix new and old batteries together. Don’t
mix rechargeable batteries with alkaline
batteries.

H100B Pulse Oximeter User Manual
- 5 -
21 Periodically check the battery for corrosion.
Remove the batteries from the oximeter if you
do not expect to use it within one month.
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 H100B Pulse 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

H100B Pulse Oximeter User Manual
- 6 -
manual.
26 Do not immerse or wet the sensor, as this may
damage the sensor.
27 There are no user-serviceable parts inside the
oximeter, the cover should only be removed by
qualified service personnel.
28 Do not spray, pour, spill liquid to the oximeter
and its accessories, connector, switch or
opening in enclosure, as this may damage the
oximeter.
29 Before cleaning the oximeter or the sensor,
make sure that the equipment is switched off
and disconnected from the power line.
30 Do not use the charger stand when the alkaline
battery is depleted or no battery is installed.
31 Do not monitor the patient while the battery is
being charged.
32 Do not disassemble batteries, or dispose of
them in fire, or cause them to short circuit. They
may ignite, explode, leak, or cause personal
injury.
33 Only use EDAN approved rechargeable

H100B Pulse Oximeter User Manual
- 7 -
batteries and charger stand for H100B pulse
oximeter.
34 A potential hazard can exist if different alarm
presets are used.
35 This equipment is not intended for family usage.
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 60601-1-1
systems requirements.
2 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. Batteries are hazardous

H100B Pulse Oximeter User Manual
- 8 -
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 H100B Pulse Oximeter will not operate with
dead batteries. Install new batteries.
4 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.
5 When adjusting any menu parameters, the
oximeter does not display SpO2or PR, but it is
still recording.
6 Do not run the pulse oximeter when alkaline
batteries of different types are used at the same
time.
7 Federal (U.S.) Law restricts this device to sale

H100B Pulse Oximeter User Manual
- 9 -
by or on the order of a physician.
1.3 Notes
NOTE:
Notes are identified by the symbol shown above.
Notes contain important information that may be
overlooked or missed.
NOTE:
1 This device has been tested and found to
comply with the limits for medical device in
IEC/EN60601-1-2 (International standard for
EMC testing of Medical Electrical Equipment,
second edition). These limits are designed to
provide reasonable protection against harmful
interference in a typical medical installation.
2 Sensor LED light emissions fall within Class 1
level, according to IEC/EN 60825-1:2001. No
special safety precautions are required.
3 Normal operation means:
The oximeter is turned on;
A sensor is connected to the oximeter;

H100B Pulse Oximeter User Manual
- 10 -
The sensor is applied to the patient;
The patient’s SpO2, Pulse rate are being
reported;
No error conditions exist.
4 Wash the probe with clean water after
disinfecting it to remove any remaining solution.
The probe can only be reused after dried
thoroughly.
5 Do not disinfect the probe with the water boiled.
6 Any residue should be removed from the probe
before being disinfected, and avoid contacting
corrosive solvent. Dipping the cable into alcohol
or alkalescent solvent for a long time may
reduce the flexibility of the scarfskin of the cable.
Also, the connector should not be dipped.
7 After monitoring, disinfect the probe according
to the instruction described in the user manual.
8 The materials with which the patient or any
other person can come into contact conform
with the standard of ISO10993.
9 The pictures and interfaces in this manual are
for reference only.

H100B Pulse Oximeter User Manual
- 11 -
10 A functional tester cannot be used to assess
the accuracy of the pulse oximeter probe or the
pulse oximeter monitor.
11 If there is independent demonstration that the
particular calibration curve is accurate for the
combination of a pulse oximeter monitor and a
pulse oximeter probe, then a functional tester
can measure the contribution of a monitor to the
total error of a monitor/probe system. The
functional tester can then measure how
accurately a particular pulse oximeter monitor is
reproducing that calibration curve.
12 The operating time of the Ni-MH rechargeable
battery package depends on the configuration
and operation of the pulse oximeter.
1.4 Symbols in the Oximeter
This symbol indicates that the
instrument is IEC/EN 60601-1
Type BF equipment.

H100B Pulse Oximeter User Manual
- 12 -
Symbol for CAUTION
Serial number
The symbol indicates that the
device complies with the European
Council Directive 93/42/EEC
concerning medical devices.
Authorized representative in the
European community
Date of manufacture
Manufacturer
P/N Part Number