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
Display Key
Display Screen
Figure 1 Front View
Battery Cover
Nameplate
Lanyard Hole
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 (SpO ) through a user's finger. It is
2
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
SpO display range: 35%~100%
2
SpO measuring accuracy:
2
≤ 2% for SpO range from 70% to 100%
2
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 SpO and PR measurement still meet the
2
precision described above when the modulation amplitude is as
low as 0.6%.
F. Ambient Light Interference:
The difference between the SpO value measured in the condition
2
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.