Creative OXY-11 User manual

OXY-11
Fingertip Oximeter
Operator’s Manual
Shenzhen Creative Industry Co., Ltd.

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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.

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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.

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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

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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 /

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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.

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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

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◆Methemoglobin
◆Dysfunctional hemoglobin
◆Artificial nails or fingernail polish
◆The Finger is too cold
◆Patients with abnormal circulation of finger endings caused
by cop

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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

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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

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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 (SpO2) through a
patient’s finger. It is applicable for spot-checking SpO2and
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.

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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

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Serial Number
Rx Only
Federal law restricts this device to sale by or on
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