Wellue PO6 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, lint,dust,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.
Do not maintain the device while it is charging.
Please keep the cable away from children. It can cause
strangulation.
Keep the device out of reach of pets, pests and
children.
The PULSE OXIMETER EQUIPMENT is calibrated to
display FUNCTIONAL OXYGEN SATURATION.
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
Charging Cable
2 Overview
Name:Pulse Oximeter
Model: PO6，PO6A
Model and Configuration see the table below.
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.When the battery is low,the display
screen will display a low power prompt.
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. 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
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
No.
Model
Appearance
color
1
PO6
Blue
2
PO6A
Gray

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 1 records.
The oldest will be overwritten by the 2th. Please
upload data to your phone in time.
3.6 How to Check Battery
Press the side button, you can switch display
between readings and battery.
3.7 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.
3.8 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.
3.9 Add a New Device
For the initial use, you need to add a new device.
1) Turn on device, run phone, select <Oxyfit>;
2) Press the button on the side of the device
3.10 Smart Vibration by SpO2
When SpO2 drops below the preset value
(threshold), the buzzer in the sensor will be
activated. When SpO2 is restored, the sound will
stop.
3.11 Smart Vibration by Pulse Rate
When your pulse frequency is higher than the
upper limit or lower than the lower limit, the buzzer
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 and then let it air dry.
• Do not use petrol, thinners or similar solvent.
• Clean the SpO2 sensor carefully with cloth
soaked 70% alcohol 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
28 g
Size
38×30×38 mm
Battery
3.7Vdc, Rechargeable Lithium-
polymer
Charge requirement
5VDC, Max. 80mA
Charge time
2-3 hours
Battery life
12-14hours for typical use
Wireless
Bluetooth 4.2 BLE
Oxygen level range
70% to 100%
SpO2 Accuracy
(Arms)
80-100%:±2%, 70-80%:±3%
Pulse Rate range
30 to 250 bpm
Pulse Rate accuracy
±2 bpm or ±2%, whichever is greater
A functional tester or SpO2simulator can be used to determine the
pulse rate accuracy.
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
1records, up to 4hours for each
Frequency range
2.402 –2.480 GHz
Max RF power
-10 dBm
Expected service life
3 years
7 Declared Accuracy
The table below shows Arms values measured using the Pulse
Oximeter in a clinical study in non-motion conditions.
Accuracy Summary by Decade
Decade
Oxygen Saturation (Arms)
70-80%
±3%
80-90%
±2%
90-100%
±2%
This graph shows plots of the error (SpO2 –SaO2) by SaO2 using
the Pulse Oximeter with a linear regression fit and upper 95% and
lower 95% limits of agreement. Each sample data point is identified by
subject from a clinical study in non-motion conditions.
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
Press the side button
for 8 seconds
Inaccurat
e
measure
d value
The device has not
been placed for
more than 30
minutes from the
colder environment
to the measuring
environment.
Measurements should
be taken before they
are left in the
measuring
environment for more
than 30 minutes
The device has not
been placed for
more than 30
minutes from the
warmer
environment to the
measuring
environment.
Measurements should
be taken before they
are left in the
measuring
environment for more
than 30 minutes

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 GmbH
Borkstrasse 10 · 48163 Muenster · Germany
TEL: [phone] FAX: [phone]
Model: PO6、PO6A
Version: A
©Copyright 2019 Shenzhen Viatom Technology Co., Ltd. All rights
reserved.
0197
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.
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.