OxySmart PC-60F User manual

OxySmart
Fingertip Oximeter
User Manual
Model: PC-60F
It's not a medical device. This device is for Sports and Aviation use
only and not intended for medical use.
Notes
Please read the manual very carefully before using this device.
Failure to follow these instructions can cause measuring
abnormality or damage to the Oximeter.
The contents contained in this manual are subject to change
without notice.
Information furnished by our company is believed to be accurate
and reliable. However, no responsibility is assumed by us for its
use, or any infringements of users or other rights of third parties
that may result from its use.
Instructions for Safe Operation
Check the device to make sure that there is no visible damage
that may affect user’s safety or measurement performance with
regard to sensors and clips. It is recommended that the device
should be inspected minimally before each use. If there is
obvious damage, stop using the device.
Special attention should be paid while the Oximeter is used
constantly under the ambient temperature over 37°C, burning
hurt may occur because of over-heating of the sensor at this
situation.
Necessary maintenance must be performed only by qualified
service technicians. Users are not permitted to service this
device.
The Oximeter must not be used with devices and accessories not
specified in User Manual.
Cautions
Explosive hazard—DO NOT use the Oximeter in environment
with inflammable gas such as some ignitable anesthetic agents.
DO NOT use the Oximeter while the user is under MRI or CT
scanning. This device is NOT MRI Compatible.
Warnings
Discomfort or pain may appear if using the Oximeter
continuously on the same location for a long time, especially for
user with poor microcirculation. It is recommended that the
Oximeter should not be applied to the same location for longer
than 2 hours. If any abnormal condition is found, please change
the position of Oximeter.
DO NOT clip this device on edema or tender tissue.
The light (the infrared light is invisible) emitted from the device is
harmful to the eyes. Do not stare at the light.
The Oximeter is not a treatment device.
Local laws and Regulations must be followed when disposing of
the device.
Attentions
Keep the Oximeter away from dust, vibration, corrosive
substances, explosive materials, high temperature and moisture.
The device should be kept out of the reach of children.
If the Oximeter gets wet, please stop using it and do not resume
operation until it is dry and checked for correct operation. When
it is carried from a cold environment to a warm and humid
environment, please do not use it immediately. Allow at least 15
minutes for Oximeter to reach ambient temperature.
DO NOT operate the button on the front panel with sharp
materials or sharp point.
DO NOT use high temperature or high pressure steam disinfection
on the Oximeter. Refer to the instructions regarding cleaning and
disinfection.
The equipment is IP22 with protection against harmful solid
foreign objects and ingress of liquid.
Please pay attention to the effects of lint, dust, light (including
sunlight), etc.
Declaration of Conformity
The manufacturer hereby declares that this device complies with the
following standards:
IEC 60601-1: 2012 Medical electrical equipment-Part 1: General
requirements for basic safety and essential performance;
ISO 80601-2-61: 2017 Medical electrical equipment-Part 2-61:
Particular requirements for basic safety and essential performance of
pulse oximeter equipment.
And it also follows the provisions of the council directive MDD
93/42/EEC.
1 Overview
1.1 Appearance
Figure 1 Front View
Figure 2 Rear View
Note: the appearance is for demonstration only, please refer to the
oximeter you purchased.
1.2 Intended Use
This Fingertip Oximeter is intended for measuring the pulse rate and
functional oxygen saturation (SpO2) through a user’s finger. It is
intended for sports or aviation use only. It should not be used to
diagnose or treat any medical condition.
1.3 Configuration
SpO2, PR
Plethysmogram
Auto on/off
Pulse bar
Pulse beep
Measuring Mode: Spot Check
Record list
2 Battery Installation
Figure 3 Battery Installation
1. Refer to Figure 3, insert two AAA size batteries into the battery
compartment properly, and note the polarity markings.
2. Replace the cover.
Please make sure that the batteries are correctly installed.
Incorrect installation may cause the device not to work.
Please remove batteries if the device is not being used for more
than 7 days to prevent and avoid potential damage from the
battery leaking. Any such damage is not covered under the
product warranty.
3 Operation
3.1 Start.
Open the clip and put finger inside the rubber cushions of the clip
(make sure the finger is in the correct position), and then clip the
finger, as shown in figure 4.
Figure 4 Put finger into the Oximeter
Wait 2 seconds, the Oximeter will power on automatically and start to
measure;
3.2. END
When finger is out, the Oximeter shuts down automatically.
3.3. Readings display screen
The screen displays as below ：
Figure 5 Figure 6
Icon “ ” on display screen means the counting-down time if the
Oximeter works at Spot check mode. The total measuring time for
Spot check mode is 30 seconds.
3.4 Recording & recall
Recording & recall functions are available. At power off status,
pressing Display key can bring up record list display screen, as shown
in figure 7. In record list screen, press Display key to shift the records
page.
Figure 7
If the time from displaying valid readings to the end of measurement
is less than 5 seconds, then no recording will be done.
Up to 12 groups of records can be stored in the record list, the newest
record is marked as M1, and the oldest record is marked as M12. The
new record will override the previous record.
If the batteries are removed from the device, then the records will be
not kept or volatile
3.5 Menu
When finger is in oximeter, long time pressing display key can enter
the setup menu screen.
Figure 8
Menu setup: Short time press Display Key to choose the setting item;
Longtime press Display Key to active the setting item, then short time
press it to modify the setting parameter; Next, longtime press Display
Key to confirm the modification and exit from this setting item. At last,
move the setting item to “Save, exit menu”, and long time pressing
Display Key to store the modification and exit from the setup menu.
“Beep”： Pulse beep option. If it is set to on, every pulse beat makes a
beep.
Attention to the operation
The finger should be put into the sensor correctly.
Do not shake the finger and relax during measurement.
Do not put wet finger directly into sensor.
Avoid placing the device on the same limb which is wrapped
with a cuff for blood pressure measurement or during venous
infusion.
Do not let anything block the emitting light from device, i.e. do
not use finger nail polish/paints.
Vigorous exercise and electrosurgical device interference may
affect the measuring accuracy.
Nail polish may affect the measuring accuracy, and too long
fingernail may cause failure of measurement or inaccurate
result.
Existence of high intensive light sources, such as fluorescence
light, ruby lamb, infrared heater or strong sunshine, etc. may
cause inaccuracy of measurement result. Please put an opaque
cover on the sensor or change the measuring site if necessary.
If the first reading appears with poor waveform (irregular or not
smooth), then the reading is unlikely true, the more stable value
is expected by waiting for a while, or a restart is needed when
necessary.
4 Technical Specifications
A. SpO2 Measurement
Transducer: dual-wavelength LED sensor with wavelength:
Red light: 663 nm, Infrared light: 890 nm.
Maximal average optical output power: ≤2mW
SpO2display range: 35%~100%
SpO2measuring accuracy:
≤ 2% for SpO2range from 70% to 100%
B. Pulse Rate measurement
PR display range: 30bpm~240bpm
PR measuring accuracy: ±2bpm or ±2% (whichever is greater)
C. Power supply requirement:
2 x LR03 (AAA) alkaline batteries
Supply voltage: 3.0VDC
Operating current: ≤40mA
D. Environmental Conditions:
Operating Temperature: 5°C ~40°C
Operating Humidity: 30%~80%
Atmospheric pressure: 70kPa~106kPa
E. Low Perfusion Performance:
The accuracy of SpO2and PR measurement still meet the
precision described above when the modulation amplitude is as
low as 0.6%.
F. Ambient Light Interference:
The difference between the SpO2value measured in the condition
of indoor natural light and that of darkroom is less than ±1%.
G. Dimensions:
56 mm (L) × 34 mm (W) × 30 mm (H)
Net Weight: approx. 60g
H. Display:
OLED
I. Classification
The type of protection against electric shock: Internally powered
equipment.
The degree of protection against electric shock: Type BF applied
parts.
The degree of protection against harmful solid foreign objects
and ingress of liquid:
The equipment is IP22 with protection against harmful solid
foreign objects and ingress of liquid.
Electro-Magnetic Compatibility: Group I, Class B
5 Packing List
1) Fingertip Oximeter
2) User Manual
3) Batteries
4) Pouch
5) Lanyard
Note: the items and its quantity are subject to change, please refer to
your subject in hand.
6 Repair and Maintenance
6.1 Maintenance
The expected service life (not a warranty) of this device is 5 years. In
order to ensure its long service life, please pay attention to the
maintenance.
Please change the batteries when the low-voltage indicator
lightens.
Please clean the surface of the device before using, with 75%
alcohol wipes, then let it air dry or wipe it dry. Do not allow
liquid to enter the device.
Please take out the batteries if the Oximeter will not be used any
more than 7 days.
The recommended storage environment of the device:
ambient temperature: -20ºC ~60ºC, relative humidity 10%~95%,
atmospheric pressure: 50kPa~107.4kPa.
The Oximeter is calibrated in the factory before sale, so there is
no need to calibrate it during its life cycle. Any SpO2 simulators
should not be used to validate the accuracy of the Oximeter,
they can only be used as functional testers to verify its precision.
The SpO2 accuracy claimed in this manual is supported by the
clinical study conducted by inducing hypoxia on healthy,
non-smoking, light-to-dark skinned subjects in an independent
research laboratory.
If it is necessary to verify the precision of the Oximeter routinely,
the user can do the verification by means of SpO2 simulator, or
it can be done by the local third party test house. Please note
that the specific calibration curve (so called R-curve) should be
selected when use of SpO2 simulator, e.g. for Index 2 series
SpO2 simulator from Fluke Biomedical Corporation, please set
"Make" to "DownLoadMake: KRK", then the user can use this
particular R-curve to test the Oximeter. If the SpO2 simulator
does not contain "KRK" R-curve, please ask the manufacturer for
helping to download the given R-curve into the SpO2 simulator.
High-pressure sterilization cannot be used on the device.
Do not immerse the device in liquid.
Display Screen
Display Key
Nameplate
Lanyard Hole
Battery Cover

It is recommended that the device should be kept in a dry
environment. Humidity may reduce the life of the device, or
even damage it.
6.2 Cleaning and Disinfecting Instruction
Surface-clean sensor with a soft cloth damped with a solution
such as 75% isopropyl alcohol, if low-level disinfection is
required, use a mild bleach solution.
Then surface-clean with a cloth damped ONLY with clean water
and dry with a clean, soft cloth.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.
Do not use the Oximeter if it is damaged.
7 Troubleshooting
Problem:
The SpO2 and Pulse Rate display instable
Can not turn on the device
No display
Solution
Place the finger correctly inside and try again.
Changing batteries.
Let the user keep calm.
If the above problem still exists please contact the local service
center.
8 Key of Symbols
Symbol
Description
%SpO2
Pulse oxygen saturation
BPM/PR
Pulse rate (beats per minute)
PI%
Perfusion Index (%)
/
Pulse Strength Bar Graph
/
Low battery voltage
CE mark
SN
Serial number
Date of manufacture
Authorised representative in the European
community
Manufacturer (including address)
BF type applied part
Attention ─ refer to User Manual
Follow WEEE regulations for disposal
9 Frequently Asked Questions
1. Q: What's SpO2?
A: SpO2means the saturation percentage of oxygen in the blood.
2. Q: What's the normal range of SpO2value for healthy people?
A: The normal range varies by individual, but usually over 95%,
otherwise, please consult your physician.
3. Q: What's the normal range of PR value for healthy people?
A: Usually, the normal range is 60bpm~100bpm.
4. Q: Why do the display value of SpO2and PR vary with time?
A: The measured SpO2and PR value changes in correspondence
with the change of user's physiological conditions.
5. Q: What to do if there is no SpO2and PR reading?
A: Do not shake the finger, and keep calm during the measurement.
Please also avoid the Oximeter and the cuff on the same limb for
blood pressure and oxygen saturation measurement
simultaneously.
6. Q: How to confirm that the SpO2reading is true or accurate?
A: Hold breath for a while (50 seconds or more), if the SpO2value
significantly decreases, it means that the SpO2reading truly reflects
the physiological condition change.
7. Q: When to replace the batteries?
A: The icon of low battery will appear on the screen when the
battery voltages are low. By then, batteries need to be replaced.
8. Q: What to do if the Oximeter is moistened or sprayed by water?
A: Remove the batteries immediately and dry the Oximeter
completely with a hair dryer.
9. Q: What factors will affect the SpO2accuracy?
A: a) Intravascular dyes such as indocyanine green or methylene
blue;
b) Exposure to excessive illumination, such as surgical lamps,
bilirubin lamps, fluorescent lights, infrared heating lamps, or direct
sunlight;
c) Vascular dyes or external used color-up product such as nail
enamel or color skin care;
d) Excessive user movement;
e) Placement of a sensor on an extremity with a blood pressure
cuff, arterial catheter, or intravascular line;
f) Exposure to the chamber with High pressure oxygen;
g) There is an arterial occlusion proximal to the sensor;
h) Blood vessel contraction caused by peripheral vessel
hyperkinesias or body temperature decreasing;
i) Low perfusion condition (Perfusion Index is small).
Please contact the local distributor or manufacturer if necessary.
Appendix EMC
The equipment meets the requirements of IEC 60601-1-2:2014.
Table 1
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.
Emissions test
Compliance
Electromagnetic
environment-guidance
RF emissions
CISPR 11
Group 1
The Fingertip Oximeter uses
RF energy only for its internal
function. Therefore, its RF
emissions are very low and
are not likely to cause any
interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The Fingertip Oximeter
suitable for use in all
establishments, including
domestic establishments and
those directly network that
supplies buildings used for
domestic purposes.
Harmonic emissions
IEC61000-3-2
N/A
Voltage
fluctuations/flicker
emissions
IEC61000-3-3
N/A
Table 2
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.
Immunity test
IEC60601 test level
Compliance
level
Electromagnetic
environment
-guidance
Electrostatic
discharge(ESD)
IEC61000-4-2
±8 kV contact
±15kV air
±8 kV
contact
±15kV air
Floors should be
wood, concrete or
ceramic tile. if
floors are covered
with synthetic
material, the
relative humidity
should be at least
30%
Electrical fast
transient/
burst
IEC61000-4-4
±2kV for power
Supply lines
±1 kV for
input/output lines
N/A
N/A
Surge
IEC 61000-4-5
±1kV line (s) to
line(s)
±2kV line(s) to
earth
N/A
N/A
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC61000-4-11
<5% UT
(>95% dip in UT) for
0.5 cycle
<40% UT
(60% dip in UT) for 5
cycles
<70% UT
(30% dip in UT) for
25 cycles
<5% UT
(>95% dip in UT) for
5 s
N/A
N/A
Power
frequency(
50Hz/60Hz)
magnetic field
IEC61000-4-8
3A/m
3A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE : UTis the a.c. mains voltage prior to application of the test
level.
Table 3
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.
Immunity
test
IEC60601
test level
Compliance
level
Electromagnetic
environment -guidance
Conducted
RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
N/A
3 V/m
Portable and mobile RF
communications
equipment should be
used no closer to any
part of The Fingertip
Oximeter, including
cables, than the
recommended
separation distance
calculated from the
equation applicable to
the frequency of the
transmitter.
Recommended
separation distance
d=1.2
P
d=1.2
P
80MHz to
800MHz
d=2.3
P
800MHz to
2.5GHz
Where Pis the
maximum output power
rating of the transmitter
in watts (W) according
to the transmitter
manufacturer and dis
the recommended
separation distance in
metres (m). b
Field strengths from
fixed RF transmitters, as
determined by an
electromagnetic site
survey ,ashould be less
than the compliance
level in each frequency
range .b
Interference may occur
in the vicinity of
equipment marked with
the following symbol.
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 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.
Table 4
Recommended separation distances between portable and mobile
RF communication the equipment
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
maximum
output power
of transmitter
W(Watts)
Separation distance according to frequency of
transmitter M(Meters)
150kHz to
80MHz
d=1.2
P
80MHz to
800MHz
d=1.2
P
80MHz to 2,5GHz
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
For transmitters rated at a maximum output power not listed above,
the recommended separation distance d in meters (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.
Version: A
Shenzhen Viatom Technology Co., Ltd.
Website: www.getwellue.com
Email: [e-mail]
Manufacturer：Shenzhen Creative Industry Co., Ltd.
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg Germany