EDAN INSTRUMENTS, INC.

Finger Oximeter
H10

User Manual
Manual Ver.: 1.0
Release Date: July. 2009
Part Number: MS1R-109755-V1. 0
 P/N: MS1R-109755-V1.0

Copyright
© Copyright EDAN INSTRUMENTS, INC.
2009. 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.
I
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.

II
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.

III
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.

Using This Label Guide

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.

IV
 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.

Revision History

Date ECO# Version Description

Complete
2009.07.03 V1.0
edition

V
 Table of Contents
1 INDICATIONS FOR USE ............................................ 1
2 PRECAUTIONS FOR USE ......................................... 1
3 SYMBOLS................................................................... 5
4 INSTALLING BATTERIES .......................................... 9
5 OPERATION INSTRUCTIONS ................................. 12
6 INSTALLING STRING............................................... 17
7 ACCESSORIES ........................................................ 18
8 MAINTENANCE AND CLEANING ........................... 18
9 TROUBLESHOOTING .............................................. 20
10 AFTER-SALES SERVICE....................................... 23
APPENDIX Ⅰ............................................................... 28
A1.1 CLASSIFICATION ............................................... 28
A1.2 SPECIFICATION ................................................. 29
A1.2.1 SIZE AND WEIGHT .......................................... 29
A1.2.2 ENVIRONMENT ............................................... 29
A1.2.3 DISPLAY ........................................................ 30
A1.2.4 BATTERIES .................................................... 30
A1.2.5 MEASUREMENT WAVELENGTHS ....................... 30
VI
 A1.3 DISPLAYED PARAMETERS SPECIFICATION ........... 31
APPENDIX Ⅱ EMC INFORMATION-GUIDANCE AND
MANUFACTURE’S DECLARATION ........................... 32
A2.1 ELECTROMAGNETIC EMISSIONS - FOR ALL
EQUIPMENT AND SYSTEMS.................................. 32
A2.2 ELECTROMAGNETIC IMMUNITY - FOR ALL
EQUIPMENT AND SYSTEMS.................................. 34
A2.3 ELECTROMAGNETIC EMISSIONS-FOR EQUIPMENT
AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING. 36
A2.4 RECOMMENDED SEPARATION DISTANCES ........... 40

VII
1 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 product is suitable for home
use, oxygen bar use and physical care in
exercise (It can be used before or after
exercise). It is intended for spot-checking of
adult and pediatric patient.

2 Precautions for Use

1. Do not use the device in an MRI or CT
environment.
-1-
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 pulse oximeter is intended only as
an adjunct in patient assessment. It
must be used with other methods of
assessing clinical signs and symptoms.
5. Do not stretch the adhesive tape while
applying the finger 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.
-2-
 Minimize patient motion as much as
possible.
8. The presence of a defibrillator may
affect the performance of the device.
9. Significant concentration of
dysfunctional hemoglobins (such as
carbonxy-hemoglobin or
methemoglobin) may affect the
accuracy of the SpO2 measurement.
10. Intravascular dyes such as indocyanine
green or methylene blue may affect the
accuracy of the SpO2 measurement.
11. Batteries may leak or explode if used
or disposed of improperly.
12. Don’t use different types of batteries at
the same time. Don’t mix fully charged
and partially charged batteries at the
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 same time. These actions may cause
batteries to leak.
13. Fingernail polish or false fingernails
may cause inaccurate SpO2 readings.
14. Patients with hypotension, severe
vasoconstriction, severe anemia, or
hypothermia may have inaccurate SpO2
readings.
15. Patients in cardiac arrest or in shock
may have inaccurate SpO2 readings.
16. The presence of high ambient light may
cause inaccurate SPO2 measurements.
17. Follow local governing ordinances and
recycling instructions regarding
disposal or recycling of the device and
device components, including batteries.

-4-
3 Symbols

No. Symbol Definition of Symbol

1 SERIAL NUMBER

2 Symbol for “WARNING”

The symbol indicates that

the device should be sent
to the special agencies
according to local
3 regulations for separate
collection after its useful
life and that this unit was
put on the market after 13
August 2005

-5-
 Not for continuous
monitoring (no alarm for
4 SpO2)

5 Low battery indication

6 Hemoglobin saturation

7 Heart rate(BPM)

-6-
8 Battery orientation

9 Type BF Applied Part

Symbol for “DATE OF

10
MANUFACTURE”

11 MANUFACTURER

The symbol indicates that

12 the device complies with
the European Council
Directive 93/42/EEC
-7-
 concerning medical
devices.

Authorized Representative
13 in the European
Community

-8-
4 Installing Batteries
When the batteries are low, the low battery
indication flashes once per second. Replace
low batteries as soon as possible, following
the instructions below.
1. Hold the device as shown below, press
upward and then pull outward slightly
with your thumb to release the device’s
battery tray.
2. Remove the battery tray and the old
batteries, dispose of the batteries
properly.
3. Insert two 1.5 volt AAA-size alkaline
batteries. Follow the polarity marks (+
and -) as illustrated.

-9-
4. Carefully guide the battery tray back
onto the device, press downward and
push inward slightly to re-secure the
battery tray.

Figure 1 Batteries Installation

- 10 -
 WARNING :
Battery polarities must be correctly
installed. Otherwise, the device might
be damaged.

- 11 -
5 Operation Instructions

Display Screen

Low Batteries Indication

Switch Button

Figure 2 Front Panel Instruction

- 12 -
The OLED display screen of the device
displays blood oxygen saturation (SpO2) and
pulse rate (BPM) and provides a visual
indication of the pulse signal. The displayed
results of SpO2 and PR are refreshed every
second. Stable measurement is obtained in
approximately 30 seconds. The values of
SPO2 and pulse rate can be displayed
properly when pulse saturation is at 0.6%.
1. Insert two 1.5V AAA-size alkaline
batteries into battery tray. Follow the
polarity marks (+ and -) as illustrated.
Carefully guide the battery tray back
into the device.
2. Nip the clamp.
3. Insert one of your fingers, nail side up,
into clamp of the Oximeter until the
- 13 -
 fingertip touches the built-in stop
guide.
4. Press the switch button on front panel
to turn on the device (The device will
automatically shut off if the screen
displays “ERR1” or “ERR2” signal for
more than three seconds).
5. Movement is not recommended during
measurement.
6. When the signals are stable, read
corresponding data from OLED
display screen.
7. The device has six display modes
shown in figure 3. If you press the
switch button twice after turning on
the oximeter, the device will change to
another display mode.
- 14 -
 Figure 3 Six Display Modes
8. You can press the switch button to turn
on/off the PR tone in every display
mode.
9. When you press and hold the switch
button for more than one second, the
brightness of the device will change
gradually. There are 10 levels of
brightness; the default level is level
five.

- 15 -
10. When the device is removed from
your finger, the screen will display
“No Finger”. The device will
automatically shut off when the signal
of “No Finger” lasts for more than
eight seconds.
Caution:
The loss of pulse signal may occur
when the patient has poor peripheral
perfusion, and the screen will display
“---”.
NOTE:
The pictures and interfaces in this
manual are for reference only

- 16 -
6 Installing String
A string and a carrying case are provided for
convenience. The device will function with
or without these accessories.
If the string use is desired, thread the string
as shown below.

Figure 4 String Installation

- 17 -
7 Accessories
1. One hang string
2. Two 1.5V AAA-size alkaline batteries
3. One user manual

8 Maintenance and Cleaning

1. Remove the batteries from the battery
tray if the Oximeter will not be used
for a long time.
2. Wipe the surface with a soft cloth
dampened with mild detergent or
isopropyl alcohol solution. If
low-level disinfection is required, a
cloth dampened with 10% bleach 90%
water solution may also be used. Do
- 18 -
 not use undiluted bleach or any other
cleaning solutions except those
recommended here, otherwise the
device may be damaged permanently.
3. Dry it with a soft cloth.
4. Ensure that all surfaces are completely
dry.
5. Don’t attempt to disassemble the
device or repair it unless you are
trained personnel.

- 19 -
9 Troubleshooting

Problems Possible Reason Solutions

Device can’t be Critical low Please replace

powered on battery batteries

Batteries might be Please

installed reinstall
incorrectly batteries

Device might be Please contact

damaged local
customer
service centre

“ERR 1” Drive circuit Please contact

displayed on might be damaged local
OLED screen customer
service centre

- 20 -
“ERR 2” Drive circuit Please contact
displayed on might be damaged local
OLED screen customer
service centre
Photoelectric Please check
sensor might be the
damaged or photoelectric
shielded sensor and
remove the
shielding
object or
contact local
customer
service centre

SpO2 or PR The sensor is Re-apply the

value can’t be applied sensor
shown incorrectly.
normally
There is very
Don’t use the

- 21 -
 bright light device in the
environment
with high
ambient light

Patient is in low
perfusion or Go to a
Patient’s hospital for
oxyhemoglobin is diagnosis
too low to be
measured

SpO2 or PR Finger might not Re-apply the

value is be inserted deep sensor
unstable enough
Please keep
Finger is quiet
trembling or
patient is moving

- 22 -
10 Warranty and Service Policy
10.1 Warranty
EDAN warrants that EDAN’s products meet
the labeled specifications of the products
and will be free from defects in materials
and workmanship that occur within
warranty period. The warranty period begins
on the date the products are shipped to
distributors.
The warranty is void in cases of:
a) damage caused by handling during
shipping.
b) subsequent damage caused by
improper use or maintenance.
c) damage caused by alteration or
- 23 -
 repair by anyone not authorized
by EDAN.
d) damage caused by accidents.
e) replacement or removal of serial
number label and manufacture
label.
If a product covered by this warranty is
determined to be defective because of
defective materials, components, or
workmanship, and the warranty claim is
made within the warranty period, EDAN
will, at its discretion, repair or replace the
defective part(s) free of charge. EDAN will
not provide a substitute product for use
when the defective product is being
repaired.
- 24 -
10.2 Service Policy
All repairs on products must be performed
or approved by EDAN. Unauthorized
repairs will void the warranty. In addition,
whether or not covered under warranty, any
product repair shall be exclusively be
performed by EDAN certified service
personnel.
If the product fails to function properly or if
you need assistance, service, or spare parts,
contact EDAN’s service center. A
representative will assist you
troubleshooting the problem and will make
every effort to solve it over the phone or
Email, avoiding potential unnecessary
returns.
- 25 -
In case a return can not be avoided, the
representative will record all necessary
information and will provide a Return
Material Authorization (RMA) form that
includes the appropriate return address and
instructions. An RMA form must be
obtained prior to any return.
Freight policy:
Under warranty: the service claimer is
responsible for freight & insurance charges
when a return is shipped to EDAN for
service including custom charges. EDAN is
responsible for freight, insurance & custom
charges from EDAN to service claimer.
Out of warranty: the service claimer is
responsible for any freight, insurance &
- 26 -
custom charges for product.
Contact information:
If you have any question about maintenance,
technical specifications or malfunctions of
devices, contact your local distributor.
Alternatively, you can send an email to
EDAN service department at:
support@edan.com.cn.

- 27 -
Appendix Ⅰ
Product Specification
A1.1 Classification
Type of Protection: Internally powered equipment
(two 1.5V AAA alkaline
batteries)
EMC Compliance: Class B
Degree of Protection: Type BF-Applied part
Mode of operation: Spot-checking
Enclosure Degree of ingress Protection: IPX2
Compliant with Safety Standards:
IEC 60601-1:1988+A1+A2
EN 60601-1:1990+A1+A2
IEC/EN 60601-1-2:2001+A1
ISO 9919:2005
- 28 -
A1.2 Specification
A1.2.1 Size and Weight
Size: 57 (L)×32 (W)×31 (H) (mm)
Weight: 57 (g) (Including battery)

A1.2.2 Environment
Temperature
Working: 5 °C ~ 40 °C
Storage: -20 °C ~ 55 °C
Humidity
Working: 25% ~ 80% (No coagulate)
Storage: 25% ~ 93% (No coagulate)
Atmospheric pressure
Working: 860hPa ~ 1060hPa
Transport and Storage: 700hPa ~ 1060hPa

- 29 -
A1.2.3 Display
SpO2: OLED display
PR: OLED display
Bar graph: 10-segment, OLED display
Data update period: one second

A1.2.4 Batteries
Power supply: two 1.5V AAA-size alkaline
Batteries
Life-span of battery: approximately 25 hours of
operation with two 1.5V
AAA-size alkaline
batteries

A1.2.5 Measurement Wavelengths

Red light: 660 nanometers
Infrared light: 905 nanometers
- 30 -
A1.3 Displayed Parameters
Specification
Displayed range
SpO2: 35 ~ 99 %
BPM: 30 ~ 240 BPM
Accuracy
SpO2: 80%~99%, ±2%
70%~80%, ±3%
Less than 70%, unspecified
PR: ±2BPM or ±3% (larger)
Resolution
SpO2: 1%
BPM: 1BPM

- 31 -
Appendix Ⅱ
EMC Information-Guidance and
Manufacture’s Declaration
Refer to the following tables for specific
information regarding this device’s
compliance to IEC/EN 60601-1-2.
A2.1 Electromagnetic Emissions - for
all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic

emissions

The oximeter is intended for use in the electromagnetic

environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.

Emissions Compliance Electromagnetic

- 32 -
test environment
-guidance

RF emissions The oximeter uses RF

CISPR11 energy only for its
internal function.
Therefore, its RF
Group 1 emissions are very low
and are not likely to
cause any interference
in nearby electronic
equipment.

RF emissions
Class B
CISPR11
The oximeter is
Harmonic suitable for use in all
emissions establishments other
N/A
IEC/EN61000 than domestic and
-3-2 those directly
connected to the public
Voltage low-voltage power
fluctuations supply net work that
/flicker supplies buildings used
N/A
emissions for domestic purpose.
IEC/EN61000
-3-3

- 33 -
A2.2 Electromagnetic Immunity - for
all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic

immunity

The oximeter is intended for use in the electromagnetic

environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.

Emissions Compliance Complian Electromagneti

test ce level c environment-
guidance

Electrostatic Floors should be

discharge(E wood, concrete
SD) or ceramic tile.
IEC/EN6100 ±6kV If floors are
0-4-2 ±6kV contact covered with
contact
±8kV air synthetic
±8kV air material, the
relative
humidity should
be at least 30%.

- 34 -
Electrical ±2kV for Mains power
Fast power supply quality should
Transient/ lines be that of a
Burst N/A typical
±1kV for
IEC/EN61 commercial or
input/output
000-4-4 hospital
lines (>3m)
environment.
Surge ±1kV for
IEC/EN61 power
000-4-5 differential
mode N/A
±2kV
common
mode

Voltage <5%UT(>95 Mains power

dips, short % dip in quality should
interruptio UT)for 0.5 be that of a
ns, and cycle typical
voltage commercial or
variations 40%UT(60% N/A hospital
on power dip in UT)for environment. If
supply 5 cycles the user of the
input lines product requires
IEC/EN61 70%UT(30% continued
000-4-11 dip in UT)for operation during

- 35 -
 25 cycles power mains
interruptions, it
<5%UT(>95 is recommended
% dip in UT) that the product
for 5s be powered
from an
uninterruptible
power supply or
a battery.

Power Power frequency

Frequency magnetic fields
( 50/60 should be at
Hz)Magne levels
tic Field characteristic of
IEC/EN 3A/m 3A/m a typical
61000-4-8 location in a
typical
commercial or
hospital
environment

A2.3 Electromagnetic emissions-for

EQUIPMENT and SYSTEMS that are
not LIFE-SUPPORTING
- 36 -
 Guidance and manufacturer’s declaration –
electromagnetic immunity

The oximeter is intended for use in the electromagnetic

environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.

Emissions IEC/EN 60601 Compliance Electromagnetic

level environment-
test test level
guidance

Conducted 3Vrms Portable and

RF IEC/EN 3V mobile RF
61000-4-6 150KHz to communications
80MHz equipment should
be used no closer
to any part of the
oximeter,
3V/m including cables,
Radiated RF
IEC/EN 80MHz to 3V/m than the
61000-4-3 2.5GHz recommend
separation
distance
calculated from
the equation
applicable to the
frequency of the

- 37 -
 transmitter.
Recommended
separation
distance

3.5
d= P
3
3.5
d= P
3
80 MHz to 800
MHz

7
d= P
3
800 MHz to 2.5
GHz
where p is the
maximum
output power
rating of the
transmitter in
watts(W)
according to the
transmitter

- 38 -
 manufacturer
and d is the
recommended
separation
distance in
meters (m).
Field strengths
from fixed RF
transmitters, as
determined by
an
electromagnetic
site survey, a
should be less
than the
compliance
level in each
frequency
range.
Interference may
occur in the
vicinity of
equipment marked
with the following
symbol:

- 39 -
 NOTE1 At 80MHz and 800MHz, the frequency range applies.

NOTE2 These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

a
Field strengths from fixed transmitters, such as base stations for
radio(cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the
location in which the oximeter is used exceeds the applicable RF
compliance level above, the oximeter should be observed to verify
normal operation. If abnormal performance

A2.4 Recommended Separation

Distances

- 40 -
 Recommended separation distances between
portable and mobile RF communications equipment and
the oximeter

The oximeter is intended for use in an electromagnetic environment

in which radiated RF disturbances are controlled. The customer or
the user of the oximeter can help prevent electromagnetic
interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the
oximeter as recommended below, according to the maximum
output power of the communications equipment.

Rated Separation distance according to frequency

maximum of transmitter(m)
output power of
transmitter(W)

150kHz to 80MHz to 800MHz to

2.5GHz
80MHz 800MHz
⎡ 3.5 ⎤ ⎡ 3.5 ⎤ ⎡7⎤
d =⎢ ⎥ P d=⎢ ⎥ P d=⎢ ⎥ P
⎣ V1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦

- 41 -
 0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 .3

10 3.7 3.7 7.4

100 12 12 3

For transmitters rated at a maximum output power not listed above,

the recommended separation distance d in metres (m) can be
estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for
the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people

- 42 -
 EDAN INSTRUMENTS, INC.
3/F-B, Nanshan Medical Equipments Park,
Nanhai Rd 1019#, Shekou,
Nanshan Shenzhen, 518067 P.R. CHINA
TEL: +86-755-26882220 FAX:
+86-755-26882223
EC REPRESENTATIVE
Shanghai International Holding Corp.
GmbH (Europe)
Eiffestrasse 80, D-20537 Hamburg Germany
TEL: +49-40-2513175 FAX:
+49-40-255726
E-mail: antonjin@yahoo.com.cn