EDAN H100N User manual

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About this Manual
P/N: 01.54.110221-13
Release Date: August 2010
© Copyright EDAN INSTRUMENTS, INC. 2008-2010.
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

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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,

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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
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

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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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Table of Contents
1 Safety Information .................................................... 1
1.1 Warnings .............................................................. 1
1.2 Cautions...............................................................11
1.3 Notes................................................................... 14
1.4 Symbols in the oximeter..................................... 17
2 Introduction............................................................. 19
2.1 General Introduction........................................... 19
2.2 Panels Introduction............................................. 21
2.3 Connecting Sensor or Cable ............................... 30
2.4 Powered by Battery ............................................ 32
2.5 Accessory List .................................................... 36
3 Oximeter Operation ................................................ 41
3.1 Turning on the Oximeter .................................... 41
3.2 Measurement State ............................................. 43
3.3 System Menu...................................................... 47
3.4 Charging the Ni-MH Battery Package................ 66
3.5 PatientCare Viewer Data Management Software
Introduction .............................................................. 67

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4 Alarm........................................................................ 70
4.1 Alarm Categories and Levels ............................. 70
4.2 Alarm Conditions ............................................... 73
5 Performance Considerations.................................. 79
5.1 Performance Verification ................................... 79
5.2 Oximeter Performance Considerations............... 79
5.3 OxiMax Sensor Performance Considerations..... 81
6 Maintenance............................................................. 85
7 Principles of Operation...........................................90
7.1 Pulse Oximetry Measurement ............................ 91
7.2 Functional Versus Fractional Saturation ............ 94
7.3 Measured Versus Calculated Saturation............. 95
8 Warranty and Service Policy.................................. 96
8.1 Warranty............................................................. 96
8.2 Service Policy..................................................... 97
AppendixⅠSpecification ....................................... 100
A1.1 Classification ................................................. 100

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A1.2 Specification.................................................. 100
A1.3 Parameters ..................................................... 103
Appendix II EMC Information............................... 105
A2.1 Electromagnetic Emissions - for all
EQUIPMENT and SYSTEMS ............................... 105
A2.2 Electromagnetic Immunity - for all
EQUIPMENT and SYSTEMS ............................... 107
A2.3 Electromagnetic emissions-for EQUIPMENT
and SYSTEMS that are not LIFE-SUPPORTING ..111
A2.4 Recommended Separation Distances..............117
Appendix ⅢRecord Table..................................... 120
Appendix ⅣAbbreviations................................... 121

H100N Pulse Oximeter User Manual Safety Information
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1 Safety Information
1.1 Warnings
AWARNING 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.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
4 Oximetry measurements and pulse signals can
be affected by certain environmental conditions,
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.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
8 H100N Pulse 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 electrosurgical unit,
and shortly thereafter. To avoid shock, the
caregiver should not hold the oximeter while using a
defibrillator on a patient.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
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.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
14 Do not make any clinical judgment based solely
on the oximeter, and 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 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.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
18 Use only Nellcor-approved OxiMax Sensors
and extension cables with the H100N Pulse
Oximeter. Other sensors or extension cables may
cause improper monitor performance or minor
personal injury.
19 H100N 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.
21 Periodically check the battery for corrosion.
Remove the batteries from the oximeter if you do
not expect to use it within one month.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
22 The device enters POST (Power-On-Self-Test)
immediately after power-on. During the POST,
confirm all the display segments and icons are
shown and the speaker sounds a few seconds tone.
Do not use the H100N Pulse Oximeter if you do not
hear the POST pass tone. Do not use the oximeter
if the POST has not been finished successfully.
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.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
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 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 H100N Pulse
Oximeter and its accessories, connector, switch or
opening in enclosure, as this may damage the
oximeter.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
29 Before cleaning the oximeter or the sensor,
make sure that the equipment is switched off and
disconnected from the power line.
30 Setting the alarm limits to extreme values can
cause the alarm system useless.
31 Do not use the charger stand when the alkaline
battery is depleted or no battery is installed.
32 Do not monitor the patient while the battery is
being charged.
33 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.
34 Only use EDAN approved rechargeable
batteries and charger stand for H100N pulse
oximeter.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
35 The temperature sensor should be disinfected
after each measurement. The probe must not be
sterilized in steam. Only detergents containing no
alcohol can be used for disinfection.
36 The temperature sensor should not be heated
above 100 (212 ). It should only be subjected to℃℉
temperatures from 80 (176 )℃℉to 100 (212 )℃℉.
37 The calibration of the temperature module is
necessary for every two years (or as frequently as
dictated by your Hospital Procedures Policy). When
you need to calibrate the temperature measurement,
please contact the manufacturer.

H100N Pulse Oximeter User Manual Safety Information
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WARNING
38 Take the TEMP probe and cable carefully. If
you do not use them for a long time, you should coil
up the probe and cable into a loose circle. If the wire
inside the cable is tensely pulled, it may cause
mechanical damage to the probe and the cable.
1.2 Cautions
A Caution label alerts the user to exercise care
necessary for the safe and effective use of the H100N
Pulse Oximeter.
CAUTION
1 All combinations of equipment must be in
compliance with IEC/EN 60601-1-1 system
requirements.

H100N Pulse Oximeter User Manual Safety Information
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CAUTION
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 waste. Do NOT
dispose of 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 H100N Pulse Oximeter will not operate with
dead batteries. Install new batteries.