EDAN H10 User manual

I
About this Manual
P/N: 01.54.109755
MPN: 01.54.109755015
Release Date: January 2019
Copyright
© Copyright EDAN INSTRUMENTS, INC.
2009-2019. 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.

II
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.

III
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.
EDAN will make available on request
circuit diagrams, component part lists,
descriptions, calibration instructions, or
other information that will assist service
personnel to repair those parts of the
equipment that are designated by EDAN as

IV
repairable by service personnel.
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.

V
Table of Contents
1 Intended use/Indicationsfor Use.............. 1
2 Precautions for Use ............................... 2
3 Symbols................................................ 15
4 Installing Batteries.............................. 19
5 Operation Instructions .......................... 22
6 SpO2Functional Test........................... 34
7 Assessing the Validity of a SpO2
Reading ................................................... 35
8 Installing String................................... 39
9 Maintenance ........................................ 40
10 Accessories ......................................... 49
11 Troubleshooting................................. 50
12 Warranty and Service Policy............ 53
12.1 Warranty...................................... 53
12.2 Service Policy.............................. 55
Appendix I Product Specification......... 58
A1.1 Classification .............................. 58

VI
A1.2 Specification............................... 59
A1.2.1 Size and Weight .................. 59
A1.2.2 Environment........................ 59
A1.2.3 Display................................ 60
A1.2.4 Batteries .............................. 60
A1.2.5 Measurement Wavelengths . 61
A1.3 Displayed Parameters Specification
............................................................. 62
Appendix II EMC Information............. 64
A2.1 Electromagnetic Emissions......... 64
A2.2 Electromagnetic Immunity ......... 66
A2.3 Electromagnetic Immunity ......... 68
A2.4 Recommended Separation
Distances ............................................. 76

H10 Finger Oximeter User Manual
- 1 -
1 Intended use/Indications for Use
The device is a small, lightweight, portable
device intended for use in measuring and
displaying functional oxygen saturation of
arterial haemoglobin (%SpO2) and pulse
rate (PR). The oximeters are intended for
use by trained healthcare professionals in
hospital environments. It is intended for
spot-checking of adult and pediatric patient.

H10 Finger Oximeter User Manual
- 2 -
2 Precautions for Use
WARNING
1 Do not use the device in an MRI or
CT environment.
2 Do not use the device in situations
where alarms are required. The
device has no alarms.
3 Explosion hazard: Do not use the
device in an explosive atmosphere.
4 The oximeter is intended only as an
adjunct in patient assessment. It
must be used with other methods of
assessing clinical signs and
symptoms.

H10 Finger Oximeter User Manual
- 3 -
WARNING
5 Do not stretch the adhesive tape
while applying the oximeter sensor.
This may cause inaccurate readings
or skin blisters.
6 Carefully read the manual and
check the device before using it.
7 In some circumstances, the device
may interpret motion as good pulse
quality. Minimize patient motion as
much as possible.
8 The presence of a defibrillator may
affect the performance of the
device.
9 Only recommended batteries can
be used for oximeter.