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.

H10 Finger Oximeter User Manual
- 4 -
WARNING
10 Significant concentration of
dysfunctional hemoglobins (such as
carbonxy-hemoglobin or
methemoglobin) may affect the
accuracy of the SpO2measurement.
11 Intravascular dyes such as
indocyanine green or methylene
blue may affect the accuracy of the
SpO2measurement.
12 Batteries may leak or explode if
used or disposed of improperly.
13 Patients with hypotension, severe
vasoconstriction, severe anemia, or
hypothermia may have inaccurate
SpO2readings.

H10 Finger Oximeter User Manual
- 5 -
WARNING
14 Don’t use different types of batteries
at the same time. Don’t mix fully
charged and partially charged
batteries at the same time. These
actions may cause batteries to leak.
15 Fingernail polish or false fingernails
may cause inaccurate SpO2
readings.
16 Patients in cardiac arrest or in shock
may have inaccurate SpO2readings.
17 The presence of high ambient light
may cause inaccurate SpO2
measurements.

H10 Finger Oximeter User Manual
- 6 -
WARNING
18 Follow local governing ordinances
and recycling instructions regarding
disposal or recycling of the device
and device components, including
batteries.
19 The simultaneous use of cardiac
pacemaker and other
patient-connected equipment may
cause safety hazard.
20 To protect eyes from damage, don't
look directly at the light emitting
parts (Infrared light is invisible).
21 Dispose of batteries in accordance
with local ordinances and
regulations.

H10 Finger Oximeter User Manual
- 7 -
WARNING
22 If several items of medical
equipment are interconnected, pay
attention to the sum of the leakage
currents, otherwise it may cause
shock hazard. Consult your service
personnel.
23 Before using the device, the
equipment and accessories should
be checked. Replacement shall be
taken if there is any evident defect
or signs of aging which may impair
the safety or performance.
24 The materials with which the patient
or any other person can come into
contact conform to the standard of
ISO10993-1: 2013.

H10 Finger Oximeter User Manual
- 8 -
WARNING
25 Ensure that the environment in
which the oximeter is used is not
subject to any sources of strong
electromagnetic interference, such
as radio transmitters, mobile
telephones, microwaves, etc.
26 As with all medical equipment,
carefully route patient cables to
reduce the possibility of patient
entanglement or strangulation. It is
especially important for children.
27 Please avoid inhalation or
swallowing of small parts.
28 The device should keep away from
pets, pests or children.

H10 Finger Oximeter User Manual
- 9 -
WARNING
29 Periodically check the battery for
corrosion. Remove the batteries
from the battery tray if the oximeter
will not be used for a long time.
30 The 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.
31 The oximeter is a prescription
device to be operated only by
trained personnel. The oximeter is
for attended monitoring only.

H10 Finger Oximeter User Manual
- 10 -
WARNING
32 The equipment 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.
33 Portable and mobile RF
communications equipment can
affect medical electrical equipment;
refer to the recommended
separation distances provided in
Appendix A2 EMC Information.
34 The oximeter can only be used on
one patient at a time.

H10 Finger Oximeter User Manual
- 11 -
WARNING
35 Correct and proper sensor
application: if the sensor is too loose,
it might compromise the optical
alignment, and even cause the
sensor to fall off. If the sensor is too
tight, (such as the application site is
too large or becomes too large due
to edema), excessive pressure and
local tissue ischemia, hypoxia and
lack of nutrition may occur on the
application site. Prolonged and
continuous monitoring may increase
the risk of skin irritations or
lacerations. To avoid these
damages, users should periodically
check surrounding skin of
application site according to the

H10 Finger Oximeter User Manual
- 12 -
patient's condition and pressure
sensor, inspect if there is sign of
stress-related damage in
surrounding tissue, and regularly
change the application site. For the
patients whose fluid is easy to
transfer and/or the patients with
systemic or localized edema, users
should inspect the skin and change
application site more frequently.
36 When serious arrhythmia is present,
the SpO2pulse rate may differ from
ECG heart rate but this does not
indicate an inaccurate PR (SpO2)
value.
37 Do not service or maintain the
oximeter or any accessory which is
in use with the patient.

H10 Finger Oximeter User Manual
- 13 -
WARNING
38 Inspect the application site every
two to three hours to ensure skin
quality and correct optical alignment.
If the skin quality changes, move
the equipment to another site.
Change the application site at least
every four hours.
39 Portable RF communications
equipment (including peripherals
such as antenna cables and
external antennas) should be used
no closer than 30 cm (12 inches) to
any part of the oximeter, including
cables specified by the
manufacturer. Otherwise,
degradation of the performance of
this equipment could result.