OxySmart PC-60FW User Manual

OxySmart
Fingertip Oximeter
User Manual
Model: PC-60FW
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 continuousl
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
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: Continuous
 Record list
 Wireless function
2 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;
If you connect device to App, you can also check readings in App.
3.2. END.
When finger is out, the Oximeter shuts down automatically.
y
3.3. Readings display screen
The screen displays as below ：
Figure 5
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 6
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 7
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.
Data transmission
The user could effectively transmit the data to App via Bluetooth.
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 Wireless
) through a user's finger. It is
2
The wireless icon Definition
The icon of
No display
icon
4.1 Download the App
App name: ViHealth Mobile
iOS: App Store
Android: Google Play
4.2 Install the App
Install the app on an Apple product or Android-powered device,
including smart phones and tablets.
4.3 Compatibility
The ViHealth app is compatible with iOS versions 9.0+ and Android
Figure 3 Battery Installation
versions 5.0+.
The compatible smart device models are listed below:
Brand
4.4 Connecting to the device
1. Keep the device on measuring.
2. Run ViHealth App on your smart device.
3. Click the device icon when ViHealth finds your
4. Follow the screen guide to start pairing.
5. Once paired, you can log on to ViHealth.
Caution: Do NOT pair the device in your smart device settings.
For more details about ViHealth App, please refer to the ViHealth App
user manual.
4.5 Real-time Monitoring
The ViHealth app supports monitoring SpO2
and HR in real-time on the Dashboard screen
(see figure 9).
4.6 Syncing Data to Apple Health
To enable/disable syncing measurement data
to Apple Health App, tap [Setting]-> [Apple
Health]->[On/Off].
The measurement data will be transferred to
Apple Health App when ViHealth App is
running.
Note: Refer the ViHealth user manual for more details.
5 Technical Specifications
A. SpO2 Measurement
B. Pulse Rate measurement
C. Power supply requirement:
D. Environmental Conditions:
E. Low Perfusion Performance:
F. Ambient Light Interference:
G. Dimensions:
H. Display: OLED
I. Classification
Definition
flashes The device is being to establish a wireless
connection with the surrounding host.
Successful wireless connection between the
device and a host is established.
1. "Wireless" function is disabled;
2. The device fails to setup a wireless connection
with the surrounding host within 3 minutes;
3.Hardware failure of wireless transmission
function while the "Wireless" function is enabled.
Model
Apple iPhone5/S, iPhone SE, iPhone6/S/Plus, iPhone7/Plus,
iPhone8/Plus, iPhone X, iPhone XS, iPhone XS Max, iPhone
XR, iPhone11, iPhone11 Pro, iPhone11 Pro Max
iPad 5/6/7, iPad Mini 1/2/3/4/5, iPad Air 1/2/3, iPad Pro
1/2/3/4
Samsung Galaxy S5/6/7/8/9/10, Note 3/5,J7
Huawei P9/10/20/30/40, Mate 10/Pro, Mate 20/Pro, Mate 30/Pro
OnePlus OnePlus 5/6/7
LG G7
Google Pixel 1/2/3/4
Pulse Oximeter (see figure 8).
Figure 8 Figure 9
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
PR display range: 30bpm~240bpm
PR measuring accuracy: ±2bpm or ±2% (whichever is greater)
2 x LR03 (AAA) alkaline batteries
Supply voltage: 3.0VDC
Operating current: ≤40mA
Operating Temperature: 5°C ~40°C
Operating Humidity: 30%~80%
Atmospheric pressure: 70kPa~106kPa
The accuracy of SpO and PR measurement still meet the
2
precision described above when the modulation amplitude is as
low as 0.6%.
The difference between the SpO value measured in the condition
2
of indoor natural light and that of darkroom is less than ±1%.
56 mm (L) × 34 mm (W) × 30 mm (H)
Net Weight: approx. 60g
The type of protection against electric shock: Internally powered
Figure 10