OXY-11

Fingertip Oximeter

Operator’s Manual

Shenzhen Creative Industry Co., Ltd.

 Instruction for User
Dear users, thanks you very much for purchasing the
Oximeter.
This manual contains the instructions necessary to operate the
product safely and in accordance with its function and
intended use. Observance of this manual is a prerequisite for
proper product performance and correct operation and
ensures patient and operator safety.
This product is reusable medical device. The using life is 2
years.

1
1 Safety

1.1 Contraindications
Do not use oximeter in a magnetic resonance (MR or CT)
environment.
1.2 Warnings
Keep the oximeter away from young children. Small parts such
as the battery door, battery and lanyard may trigger choking
hazards.

2
1.3 Cautions
● Do not use oximeter in the present of flammable anesthetics.
● The oximeter needs to be used according to information
provided in the user manual.
● The equipment is NOT intended for neonate and infant.
● Do not use a damaged oximeter which may affect
measurement performance.
● Do not place the oximeter on the same hand/arm when
using a blood pressure cuff or monitor.
● Do not use the oximeter for more than 5 minutes without
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relocating the device to another finger.
● Do not place the oximeter on edema or fragile tissues.
● Do not use the oximeter as the only basis for making medical
decision,it is intended only to be used as
addtional information that you can give to your licensed
health care professional.
● Do not use the oximeter in high frequency environment such
as electrosurgical equipment.
● Do not place the oximeter in liquid.
● Follow local disposal and recycling laws for the oximeter and
4
its components,including the battery.
● Do not stare the light(the infrared is invisible) which emitted
from the oximeter is harmful to the eyes.
● For clinical limitations and contraindications, please carefully
review the medical literature
● The equipment is just a clinical diagnosis of auxiliary
equipment. The physiological data displayed on the
equipment are for reference only and can not be directly used
for diagnostic interpretation.
● Not suitable for the users with arrhythmia / heart failure /
5
Low perfusion (PI <0.3) / finger trembling.
● Not suitable for the users with large finger size or exceeding
oximeter's finger measurement cavity size.
● Please don't use the thumb and tail finger to measure .
● Discomfort or pain may appear if using the equipment
ceaselessly,especially for microcirculation barrier
patients, it recommended that the equipment should not be
used on the same finger more than 5 minutes.
● The oximeter is designed to measure the percentage of
arterial oxygen saturation of functional hemoglobin.
6
 Any of the following conditions may reduce the performance
of the oximeter.
◆ Flicking or very bright light
◆ Moisture in the oximeter
◆ The individual weight less than 20kgs
◆ Week pulse quality(low perfusion)
◆ Venous pulsations
◆ Low hemoglobin
◆ Cardiogreen and other intravascular dyes
◆ Carboxyhemoglobin
7
◆ Methemoglobin
◆ Dysfunctional hemoglobin
◆ Artificial nails or fingernail polish
◆ The Finger is too cold
◆ Patients with abnormal circulation of finger endings caused
by cop

8
2 The Basics
The oxygen saturation is the percentage of HbO2 in the total
Hb in the blood, so-called the O2 concentration in the blood .It
is an important bio-parameter for respiration. A number of
diseases relating to respiratory system may cause the decrease
of SpO2 in the blood, furthermore, some other causes such as
the malfunction of human body’s self-adjustment, damages
during surgery, and the injuries caused by some medical
checkup would also lead to the difficulty of oxygen supply in
human body. And the corresponding symptoms would appear
9
as a consequence, such as vertigo, impotence, vomit etc.
Serious symptoms might bring danger to human’s life .
therefore, prompt information of patients SpO2 is of greats
help for the doctor to discover the potential danger, and is of
great importance in the clinical of medical field.

2.1 Principle
Principle of the oximeter is as follows: An experience formula
of data process is established taking use of Lambert Beer Law

10
according to Spectrunm Absorprtion characteristic of Reductive
hemoglobin(Hb) and oxyhemoglobin(HbO2)in
glow&near-infrared zones. Opertation Principle of the device
is:Photoelectric Oxyhemoglobin Inspection Technology is
adopted in accordance with Capacity Pulse Scanning Recording
Technology,So that two beams of different wavelength of lights
can be focused onto human nail tip through perspective clamp
finger-type sensor.Then measured signal can be obtained by a
photosensitive element, information acquired through which
will be shown on screen through treatment in electronic
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circuits and microprocessor.

Figure 1 Oximeter‘s schematic illustration

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2.2 Introduction

2.2.1 Intended Use

This Fingertip Oximeter is intended for measuring the pulse
rate and functional oxygen saturation (SpO 2) through a
patient’s finger. It is applicable for spot-checking SpO2 and
pulse rate of adult and pediatric patients in homes and medical
clinics.
Warning:
·The oximeter is NOT designed for newborn and infant. For
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adults and children,it recommended that the finger thickness
should between 8-25.4mm.
NOTES:
·The probe is the hole in the middle of the equipment to
which the finger insert.
·The Probe is the Applied part of the equipment.

2.2.2 Features
· The oximeter is small in volumes, light in weight and easy
to carry,
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 · One button and easy to operate.
· There are three modes: power off , sleep and measure.
· Automatically turning into sleep mode within 8 seconds
after there is no signal.
Notes:
·Press the operating button to activate oximeter(measure
mode) from sleep mode.
·Power off after removing the batteries.

15
2.3 Front View

Figure 2 Front view

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2.4 Functions

Display OLED
Spo2 parameter measurement Y
Pulse rate parameter measurement Y
Bar graph display Y
Battery display Y
Automatically enters sleep mode Y
Pulse waveform display Y
Four direction display Y

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2.5 Symbols

Symbol Definition

%SpO2 Pulse Oxygen Saturation (%)

PR Pulse Rate (BPM)
+/- Battery positive/ cathode electrode
This item is compliant with Medical Device
Directive 93/42/EEC
Caution, Consult Accompanying Documents

18
 Serial Number
Federal law restricts this device to sale by or on
Rx Only
the order of a licensed healthcare practitioner
Power indication(some models have no battery
capacity indicator, but have low battery
indicator)

Date of Manufacturer

Manufacturer

19
 BF Type Applied Part

The device has no Alarm System

The product is protected against harmful effects
IPX2
of dripping water per IEC 60529.
Federal law restricts this device to sale by or on
Rx Only
the order of a licensed healthcare practitioner
Power indication(some models have no battery
capacity indicator, but have low battery
indicator)

20
3 Battery Installation
A.Put the two AAA
batteries into battery
compartment in correct
polarities.
B.Push the battery cover
horizontally along the
arrow shown as figure 3.
Figure 3 Battery installation

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WARNINGS
● Battery polarities should be correctly
installed,otherwise,damag may be caused to the equiment.
● Please remove the batteries if the oximeter will be stored for
mo than 30 days.
● Please remove the batteries if you want to turn off the
oximeter. Otherwise it is always in power state.
● Battery may leak or explode if used or disposed off improper

22
4 Operating Guide

4.1 Application Method

A.Remove the battery cover,and insert the two AAA batteries
following polarity markings indicated inside of the battery
compartment,then reposition the cover.
B.Hold the oximeter with the display facing toward you,slide
your finger into the opening probe of the device,as shown
below(Figure 4),until the fingertip touches the built-in stop
guide.For best results,make sure the finger is centered with in

23
the finger guide.
C.Press the button to activate the oximeter from sleep mode,
and then measurement interface will appear in 3 seconds.
D.The measurement result will be read directly from the
screen.
E.The oximeter will turn into sleep mode automatically within 8
seconds after the finger left the probe.

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4.2 Attention for Operation
A. Ring finger, middle finger and index finger are
recommended as suitable monitor position
B. Excessive or rapid movement may affect measurement

25
 accuracy
C. Improper sensor placement may affect the measurement
accuracy
D. The oximeter can be reused after cleaning and disinfection
E. The measurement comes to the best when the oximeter
and the heart are at the same level.
F. The plethysmogram can be used as pulse intensity indicator.
The displayed parameters
G. might be unreliable with the discorderly plethysmogram.
H. unreliable with un-periodic change.
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I. The displayed parameters will show invalid indicator as '---' if
signal quality is very low.
J. The displayed parameters will show invalid indicator as '---' if
oximeter fault occur.
K. The maximum continuous test time does not exceed 5
minutes.

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5 Specifications

5.1 Classification
Type of protection against electric shock: Internally powered
equipment.
Degree of protection against electric shock: Type BF-Applied
part (non-defibrillation proof)
Operating mode: Spot checking
The degree of protection against harmful solid foreign objects
and ingress of liquid: IPX2

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5.2 Measurement Specifications
SpO2 declared accuracy
Display range: 70% to 99% ±2 digits;
0% to 69% Unspecified
Resolution: 1%
Update Period: 1s
Averaging Time: 8s
PR declared accuracy
Display range: 25 to 250±3 digits
Resolution: 1 bpm
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Update Period: 1s
Averaging Time: 8s
5.3 Power Requirements
Specification……………………………Two 1.5V(AAA)
Operating Voltage…………………… DC 2.3-3V
5.4 Environmental Specifications
Temperature (ºC)
Operating…………………………………+41º to +104 ºF / 5º to 40 ºC
Storage/transportation…………….-4º to +140 ºF / -20º to 60 ºC

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Humidity
Operating…………………………………10 % to 95% non-condensing
Storage/transportation……………10 % to 95% non-condensing
Atmosphere Pressure
Operating…………………………………70 to 106 kpa
Storage/transportation……………50 to 107.4 kpa
5.5 Physical Specifications
Width*Height*Depth………About 33x36x58mm
Weight………………………………About 60 g (including the batteries)

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5.6 Display Specifications

Display type OLED, 0.96", 128×64 pixel

SpO2%, PR, battery indicator, Pulse
Display content
rate bar graph, pulse waveform.
5.7 LED Wavelength

Wavelength Radiant Power

RED 660±6nm 1.8mW

IR 905±10nm 2.0mW

32
6 Maintenance

6.1 Maintenance
The equipment’s design life expectancy is about 2 years, keep
your equipment and accessories free of dust and dirt, and
follow these rules:
A. Please clean the equipment before use according to chapter
6.2; Remove the batteries inside the battery cassette if the
equipment will not be operated for a long time;
B. Replace the batteries in time when the battery voltage

33
indicate lamps were empty;
C. It is recommended that the equipment should be kept in a
dry environment with no corrosive gases and good ventilation
anytime. The moisture and high-light environments will affect
its lifetime and even might damage the equipment.
D. It is best to preserve the product in a place where the
temperature is between -20 to 60℃ and the relative humidity
is less than 95%.
E. The packed equipment can be transported by ordinary
conveyance. The equipment can not be
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 transported mixed with toxic, harmful, corrosive materials.
WARNING
 No modification of this equipment is allowed.
6.2 Disposal

Dispose of the oximeter in accordance with local environment

and waste disposal laws and regulations.

35
7 Cleaning/Disinfection
Cautions
● Never immerse or soak the oximeter.
●We recommend that the oximeter be cleaned and disinfected
after use every time or determined by your hospital’s policy,to
avoid long term damage to the oximeter.
● Never use cleaning agents/disinfectants other than the
recommended.
● The sensor component is not cleaned and disinfected during
testing
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7.1 Cleaning
The recommended cleaning agents include: water
1. Shut down the oximeter and remove the battery.
2. Clean the oximeter with cotton or soft cloth moistened
with water.
3. After cleaning, wipe off the water with a soft cloth.
4. Allow the oximeter to air dry.
7.2 Disinfection
The recommended disinfectants include: ethanol

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70%,isopropanol 70%.
A. Shut down the oximeter and remove the battery.
B. Clean the oximeter as instructed above.
C. Disinfect the oximeter with cotton or soft cloth moistened
with one of the recommended disinfectants.
D. After disinfection, be sure to wipe off the disinfectant left on
the oximeter with a soft cloth moistened with
water.
E. Allow the oximeter to air dry.

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8 Accessories
1. One lanyard
2. Two AAA batteries
3. One user manual
4. One certificate card
Note:

For particular configuration of accessories please refer to the

product package list.

39
9 Troubleshooting

9.1 Troubleshooting
WARNINGS :
●Necessary maintenance must be performed by qualified
service personal ONLY.
●Users are NOT permitted to maintain the equipment by
themselves.
●There are NO replaceable components in the equipment

40
Appendix
The equipment meets the requirements of IEC
60601-1-2:2014.
Guidance and manufacturer’s declaration-electromagnetic
emission
The Fingertip Oximeter is intended for use in the
electromagnetic environment specified below. The customer
or the user of the Fingertip Oximeter should assure that it is
used in such an environment.
Electromagnetic
Emissions test Compliance environment-guidance

41
 The Fingertip Oximeter
uses RF energy only for its
internal function.
RF emissions Therefore, its RF
Group 1
CISPR 11 emissions are very low
and are not likely to cause
any interference in nearby
electronic equipment.
RF emissions The Fingertip Oximeter
Class B
CISPR 11 suitable for use in all
Harmonic emissions establishments, including
N/A domestic establishments
IEC61000-3-2

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 Voltage and those directly
fluctuations/flicker network that supplies
emissions N/A
buildings used for
IEC61000-3-3 domestic purposes.

Guidance and manufacturer’s declaration-electromagnetic

emission
The Fingertip Oximeter is intended for use in the
electromagnetic environment specified below. the customer or
the user of the Fingertip Oximeter should assure that it is used
in such an environment.

43
 Electromagnetic
IEC60601 test Complian
Immunity test environment
level ce level
-guidance
Floors should be
wood, concrete
or ceramic tile. if
Electrostatic floors are
±8 kV
discharge(ESD ±8 kV contact covered with
contact
) ±15kV air synthetic
±15kV air
IEC61000-4-2 material, the
relative humidity
should be at least
30%
44
Electrical fast
±2kV for power
transient/ Supply lines
N/A N/A
burst ±1 kV for
IEC61000-4-4 input/output lines
±1kV line (s) to
Surge line(s)
N/A N/A
IEC 61000-4-5 ±2kV line(s) to
earth

45
 <5% UT
Voltage dips, (>95% dip in UT)
short for 0.5 cycle
interruptions <40% UT
and voltage (60% dip in UT) for
5 cycles N/A
variations on <70% UT N/A
power supply (30% dip in UT) for
input lines 25 cycles
IEC61000-4-1 <5% UT
(>95% dip in UT)
1 for 5 s

46
 Power frequency
magnetic fields
Power should be at
levels
frequency(
characteristic of
50Hz/60Hz) 3A/m 3A/m
a typical location
magnetic field in a typical
IEC61000-4-8 commercial or
hospital
environment.
NOTE : UT is the a.c. mains voltage prior to application of the
test level.

47
 Guidance and manufacturer’s declaration – electromagnetic
immunity
The Fingertip Oximeter is intended for use in the
electromagnetic environment specified below. The customer or
the user of The Fingertip Oximeter should assure that it is used
in such an electromagnetic environment.
Electromagnetic
Immunity IEC60601 Compliance
environment
test test level level
-guidance

48
 Portable and mobile
RF communications
equipment should be
used no closer to any
part of The Fingertip
Oximeter, including
cables, than the
Conducted 3 Vrms recommended
RF 150 kHz to N/A separation distance
IEC61000-4- 80 MHz calculated from the
6 equation applicable
to the frequency of
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 the transmitter.
Recommended
separation distance
Radiated RF 3 V/m d=1.2 P
IEC61000-4- 80 MHz to 3 V/m d=1.2 P 80MHz to
3 2.5 GHz 800MHz
d=2.3 P 800MHz to
2.5GHz
Where P is the
maximum output
power rating of the

50
 transmitter in watts
(W) according to the
transmitter
manufacturer and d is
the recommended
separation distance in
metres (m). b
Field strengths from
fixed RF transmitters,
as determined by an
electromagnetic site
survey ,a should be
51
 less than the
compliance level in
each frequency
range .b
Interference may
occur in the vicinity of
equipment marked
with the following
symbol.

52
NOTE 1: At 80 MHz and 800 MHz, 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.
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, and electromagnetic site survey should be
considered. If the measured field strength in the location in
53
which The Fingertip Oximeter is used exceeds the applicable RF
compliance level above, The Fingertip Oximeter should be
observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as
re-orienting or relocating The Fingertip Oximeter.
b: Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than 3V/m.

Recommended separation distances between portable and

mobile RF communication the equipment

54
The Fingertip Oximeter is intended for use in an
electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of The Fingertip
Oximeter can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Fingertip
Oximeter as recommended below, according to the maximum
output power of the communications equipment.
Rated Separation distance according to frequency of
maximum transmitter M(Meters)

55
output power 150kHz to 80MHz to 80MHz to
of transmitter 80MHz 800MHz 2,5GHz
W(Watts)
d=1.2 P d=1.2 P d=2.3 P
0,01 N/A 0.12 0.23

0,1 N/A 0.38 0.73

1 N/A 1.2 2.3

10 N/A 3.8 7.3

100 N/A 12 23

56
For transmitters rated at a maximum output power not listed
above, the recommended separation distance d in metres (m)
can be determined 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.

57
Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park,
Songbai Road, Xili Street, Nanshan District, 518110
Shenzhen, P. R. China
Tel: +86-755-2643 3514 Fax: +86-755-2643 0930
E-mail: info@creative-sz.com
Website: www.creative-sz.com
Shanghai International Holding Corp. GmbH (Europe)
Add: Eiffestrasse 80, 20537 Hamburg, Germany
Tel: +49-40-2513175 Fax: +49-40-255726