Viatom PO2 User manual

Pulse Oximeter
Instruction for Use
1. Introduction
1.1 Intended use
This Pulse Oximeter is intended to be used for
measuring, displaying and storing of pulse oxygen
saturation (SpO2), pulse rate of adults in home or
healthcare facilities environment.
1.2 Contraindications
No contraindications.
1.3 Warnings and Cautions
DO NOT squeeze the sensor part or apply excessive
force on it.
Do not use this device during MRI examination.
Do not use this device with a defibrillator.
Do not store the device in the following locations:
locations in which the device is exposed to direct
sunlight, high temperatures or levels of moisture, or
heavy contamination; locations near to sources of
water or fire; or locations that are subject to strong
electromagnetic influences.
Do not use the device in a combustible environment
(i.e., oxygen-enriched environment).
Never submerge the device in water or other liquids.
Do not clean the device with acetone or other volatile
solutions.
Do not drop this device or subject it to strong impact.
The device and accessories are provided non-sterile.
Do not place this device in pressure vessels or gas
sterilization device.
Do not dismantle the device, as this could cause
damage or malfunctions or impede the operation of the
device.
Consult your doctor immediately if you experience
symptoms that could indicate acute disease.
Do not self-diagnose or self-medicate on the basis of
this device without consulting your doctor. In particular,
do not start taking any new medication or change the
type and/or dosage of any existing medication without
prior approval.
Use only cables, sensors and other accessories
specified in this manual.
Prolonged continuous monitoring may increase the risk
of undesirable changes in skin characteristics, such as
irritation, reddening, blistering or burns.
Do not open the device cover without authorization.
The cover should only be opened by a qualified service
personnel.
The biocompatibility testing has been performed on the
materials in contact with the person in accordance with
ISO10993.
Do not place the SpO2probe on a finger with edema or
fragile tissue.
Check the SpO2sensor and cable before use. Do not
use a damaged SpO2sensor.
Check the SpO2sensor application site every 6-8 hours
to determine the positioning of the sensor and the
circulation and skin sensitivity of the patient. Patient
sensitivity varies depending on medical status or skin
condition. For patients with poor peripheral blood
circulation or sensitive skin, inspect the sensor site
more frequently.
The functional tester cannot be used to assess the
accuracy of the SpO2sensor or a device.
The device has no alarm system.
Continuous use for a long time may cause allergies,
redness, blistering or burns. Check the wearing
position every 6-8 hours.
The local laws and regulations should be followed
when disposing of the device and accessories.
The battery inside this product cannot be replaced.
1.4 Guide to Symbols
Symbol
Description
Type BF-Applied Part
Manufacturer
Date of manufacture
Authorized Representative in the
European Community
Follow Instructions for Use.
MRI unsafe. Presents hazards in
all MR environments as device
contains strongly ferromagnetic
materials.
IP22
Protected against spraying water
and against access to hazardous
parts with a tool, per IEC60529.
SN
Serial number
No alarm system
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Indicate separate collection for
electrical and electronic equipment
(WEEE).
1.5 Unpacking
Device
User Manual
Data/ Charging Cable
2 Overview
Name: Pulse Oximeter
Model: PO2
1. Touch Switch:
Wake up the screen and switch the interface.
2. Backlit Screen:
Show SpO2value and pulse rate value .
3. USB Charging Port:
Can be charged and data transmission.
4. Sensor:
The device turns on/off automatically in a moment after
you take on/off the sensor.
The blood SpO2and pulse rate can be measured.
3 Using the Device
3.1 Charging
Use the USB cable to charge the product. Connect
the USB cable to a USB charger or to the PC.
There will be a battery logo flash on the device
when charging.
A fully charge will need 2-3 hours. After fully
charged, the device will power off automatically.
Note: The device cannot be used during charging,
and if choosing a third party charging adaptor
(Class II), select one that complies with IEC60950
or IEC60601-1.
3.2 POWER ON/OFF
POWER ON:
Wear the device, it will turn on automatically.
POWER OFF:
The device turns off automatically in a moment
after you take off the sensor.
3.3 Typical steps
1) START. After charge the battery ,wear the
device to power on.
2) STOP. Take off the device, the recording will
be over after the countdown.
3) DATA Uploading. Run your phone to
download data.
3.4 Start working
1) Wear the device on index finger. Try to
move the device along the forefinger to find
out a best fit. Avoid being loose. Loose
wearing causes inaccurate measure.
2) Device will turn on automatically. After a few
seconds, the device will begin to work.
Notice:
If the working time is less than 2 minute, the
data will not be saved.
Please avoid excessive motion.
Please avoid strong ambient light condition.
SpO2measurement principle:
The Pulse Oxiemter is a lightweight, portable
health oximeter for use in the home or in
Sensor

healthcare facilities. SpO2 measurement
technology is based on developed photoelectron
method, the circuit design and calculation software
was developed by Shenzhen Viatom Technology
Co., Ltd. The SpO2 sensor receives the optical
signal from the red light and infra-red light through
the finger. Insert the finger into the oximeter, there
are two emitting tube (red light diodes and infrared
diodes) located on the inner upside of the sensor
and they can emit red light and infrared; There is
the receiving end located on the inner downside of
the sensor, and it can transmit the red light and
infrared into the pulse signal through finger. The
MCU receives the pulse signal, gets the frequency
signal by counting, processes its digital signal, and
finally gets the measured SpO2 value. The PR is
averagely calculated by above peak intervals of PR
waveform.
3.5 Stop working & Upload data
Take off the device, the countdown
will begin.
(If the working time is less than 2 minute, there will
be no countdown)
During the countdown, if you wear the device again,
the record will be resumed.
After the countdown, the data will be ready for
uploading.
Notice: The built-in memory can store 4 records.
The oldest will be overwritten by the 5th. Please
upload data to your phone in time.
3.6 Screen Wake up
The screen will go off automatically for saving
power in Standard Mode; you can touch the key on
top to wake up the screen.
3.7 How to Check Battery
Touch the key on top, you can switch display
between readings and battery.
3.8 Unavailable Symbol
When this symbol displays on device screen, it
indicates the readings is unavailable right now.
It may caused by:
Excessive movement;
Poor signal, finger is too cold;
Usually, the readings will recover in a few seconds
when at rest.
3.9 Bluetooth Connection
The device Bluetooth will be enabled automatically
after it’s turned on.
To establish a Bluetooth connection,
1) keep the device Bluetooth enabled.
2) Make sure the phone Bluetooth is enabled.
Notice:
DO NOT PAIR in the settings of your phone.
3.10 Add a New Device
For the initial use, you need to add a new device.
1) Turn on device, run phone, select <O2Ring>;
2) Touch the key on top of device.
3.11 Smart Vibration by SpO2
The vibrator in the sensor will be activated when
the SpO2fall below the pre-set value (Threshold).
The vibration will stop when the SpO2recover.
3.12 Smart Vibration by Pulse Rate
When your pulse rate is above the Upper
Threshold or below the Lower Threshold, vibration
will be activated.
4 Maintenance
4.1 Time & Date
After connection with phone, device time will
upload from your phone time automatically.
4.2 Cleaning
The device can be repeatedly used. Please clean
before reuse as follow:
• Clean the device with a soft, dry cloth with 70%
alcohol.
• Do not use petrol, thinners or similar solvent.
• Clean the cuff carefully with cloth soaked 70%
alcohol.
• The cuff must not be washed!
• Clean on the monitor and the arm cuff, and
then let it air dry.
Note: The device is a non-sterile medical device
and does not contain any sterile or degradable
component thus the device is not subject to the
shelf life requirements.
5 Troubleshooting
6 Specifications
Environmental
Operating
Storage
Temperature
5 to 40°C
-25 to 70°C
Relative humidity
(noncondensing)
10% to 95%
10% to 95%
Barometric
700 to 1060hPa
700 to 1060hPa
Protection
against electric
shock
Internally powered equipment
Degree
protection
against electrical
shock
Type BF
Electro-magnetic
compatibility
Group I, Class B
Degree of dust &
water resistance
IP22
Weight
15 g
Size
38×30×38 mm
Battery
3.7Vdc, Rechargeable Lithium-
polymer
Charge
requirement
5VDC, Max. 40mA
Charge time
2-3 hours
Battery life
12-16 hours for typical use
Wireless
Bluetooth 4.2 BLE
Oxygen level
range
70% to 100%
SpO2 Accuracy
(Arms)
80-100%:±2%, 70-79%:±3%
A functional tester or SpO2 simulator can be used to
determine the pulse rate accuracy.
Pulse Rate range
30 to 250 bpm
Pulse Rate
accuracy
±2 bpm or ±2%, whichever is
greater
Wavelength / Max
emission power
660nm/940nm, 0.8mW/1.2mW
SpO2data
averaging time
8s
SpO2data update
period
1s
Vibration source
low oxygen level;
high/low pulse rate
Recorded
parameters
Oxygen level, Pulse Rate
Record interval
4s
Data storage
4records, up to 10 hours for each
Frequency range
2.402 –2.480 GHz
Max RF power
-10 dBm
Expected service
life
3 years
7 FCC Warnning:
Any Changes or modifications not expressly
approved by the party responsible for compliance
could void the user's authority to operate the
equipment.
Problem
Possible Cause
Possible Solution
Device
does not
turn on
or no
response
Battery may be low.
Charge battery and try
again.
Device might be
damaged.
Please contact your
local distributor.
Software exception
Keep device in
charging, touch the
key for 8 seconds.

This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference,
and
(2) this device must accept any interference
received, including interference that may cause
undesired operation.
Note: This equipment has been tested and found to
comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits
are designed to provide reasonable protection
against harmful interference in a residential
installation. This equipment generates uses and
can radiate radio frequency energy and, if not
installed and used in accordance with the
instructions, may cause harmful interference to
radio communications. However, there is no
guarantee that interference will not occur in a
particular installation. If this equipment does cause
harmful interference to radio or television reception,
which can be determined by turning the equipment
off and on, the user is encouraged to try to correct
the interference by one or more of the following
measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment
and receiver.
-Connect the equipment into an outlet on a circuit
different from that to which the receiver is
connected.
-Consult the dealer or an experienced radio/TV
technician for help.
The device has been evaluated to meet general RF
exposure requirement. The device can be used in
portable exposure condition without restriction.
Manufacturer: Shenzhen Viatom Technology Co., Ltd
ddress: 4E, 3#, Tingwei Industrial Park, Honglang
North 2nd Road, Baoan
District, Shenzhen, China
Weibsite: www.welluehealth.com
MedNet EC-REP GmbH
Borkstraße 10
48163 Münster Germany
Telefon: [phone]
Telefax: [phone]
Model: PO2
Version: A
©Copyright 2019 Shenzhen Viatom Technology Co., Ltd.
All rights reserved.
0197