Viatom BabyO2 User manual

1
BabyO2
Pulse Oximeter
User Manual
Contact us: [email protected]
Website: www.welluehealth.com
TM

2
Contents
1 Introduction................................................................ 3
2 Overview.................................................................... 4
3 Using the device and App ..........................................5
4 PC software ............................................................. 13
5 Maintenance ............................................................ 13
6 Troubleshooting .......................................................14
7 Specifications .......................................................... 14
8 Symbols.................................................................... 16

3
1 Introduction
1.1 Intended use
This Pulse Oximeter is intended to be used for measuring the
pulse oxygen saturation (SpO2), pulse rate of adults, children
and newborns in home or healthcare facilities environment.
1.2 Contraindications
No contraindications.
1.3 Warnings and Cautions

DO NOT twist the sensor and the wrap or apply excessive force on
them.
Do not use this device during MRI examination.

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.
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

4
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 SpO2 probe on a finger with edema or fragile
tissue.

Check the SpO2 sensor and cable before use. Do not use a
damaged SpO2 sensor.
Check the SpO2 sensor 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
SpO2 sensor or a device.
The device has no alarm system.

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 Unpacking
Device ( main unit )
Sensor cable

Soft wraps

User Manual
Data/Charging Cable
2 Overview
Name: Pulse Oximeter
Model: PO5, PO5-1, PO5-2, PO5-3
Device（main unit）:
Display device status and testing results.

Sensor cable:

5
Connect the sensor and device.

Soft wraps:
Secure the sensor and the device.
Data/Charging Cable:
Can be charged and data transmission.
3 Using the device and App
3.1 Download App
App name: ViHealth
iOS: App Store
Android: Google Play
Notice: if you have installed the App before, please update it
to the latest version.
3.2 Charging
Charge the battery before using.
Connect the device to USB of computer or USB charging
adapter with the supplied cable.
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.
3.3 POWER ON/OFF
POWER ON:
Press the side button for 2 seconds.
POWER OFF:
3 ways:

Press the side button for 2 seconds.

Unplug the sensor cable, it will power off automatically

6
if not connected to phone for 2 minutes.

Even with sensor cable connected, it will power off
automatically if no working for 10 minutes.
3.4 Placement Guide before working
To ensure that the measurement is performed normally, please
follow the steps below to wear the device.
1) Plug the sensor cable into the device
2）Secure the sensor(For newborn)
A. Place the foot wrap on the foot (either foot works),
with the sensor part running on the outside edge of
Sensor cable
Foot/finger wrap
Ankle/wrist wrap
Light detector
Light emitter
(Turns red
when working)
Sensor

7
the foot. The device should be oriented to the
baby’s leg.
B. Put the foot wrap around the foot and attach the
velcro securely with no gap between the foot wrap
and the baby’s skin. The light emitter and the
light detector should be opposite to each other
on the two sides of the foot.
Note:
For the right foot, the Light Emitter should be on
the top; for the left foot, the Light Emitter should
be on the bottom.
C. Put the ankle wrap around the ankle, attach the velcro
to secure the device.
3) Secure the sensor (For adult/child)
Light emitter
Light detector

8
A. Tie the finger wrap with the sensor to the finger of the
appropriate size.
B. The sensor cable should run along the direction of the
palm.
C. The light emitter and the light detector should be
opposite to each other on the two sides of the finger.
D. Put the finger wrap around the finger and attach the
velcro securely with no gap between the finger wrap and
the skin.
E. Plug the sensor cable into the device.
F. Put the wrist wrap around the wrist, attach the velcro
to secure the device.
3.5 Start working
After the placement, press the side button for 2 seconds to
power on. There should be red light inside the soft wrap.
After displaying time and battery, you can change the
reminder settings with side button (usually you can do
nothing). You can also change the settings in App (illustrated
later). It’s easier to set in App.
After a few seconds, readings will be displayed on the screen.
Pulse rate
Oxygen level
Pulse bar

9
If the screen display “poor signal”, please check if the sensor
has been positioned and secured properly.
When the above symbol displays on device screen, it
indicates the readings is unavailable right now.
When at rest, there will be readings in a few seconds. If you
can’t get readings for a long time, it may be caused by:

Improper sensor placement

Frequent movement
Foot or finger is too cold
Run App to connect the device, you can check the real-time
readings in App Dashboard. (The detail of using App will be
illustrated later)
Notice:

If the working time is less than 2 minute, the data will
not be saved.
Motion may cause readings unavailable. Readings
recover very soon at rest.

Please avoid strong ambient light condition.
SpO2measurement principle:
The Pulse Oximeter is a lightweight, portable health oximeter
for use in the home or in healthcare facilities. SpO2

10
measurement technology is based on developed photoelectron
method, the circuit design and calculation software was
developed by Shenzhen Viatom Technology Co., Ltd. The
SpO2sensor 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 SpO2value. The PR is averagely
calculated by above peak intervals of PR waveform.
3.6 Stop working & sync data
Unplug the sensor cable, the countdown
on the screen will begin.
During the countdown, if you plug the sensor cable again, the
record will be resumed.
After the countdown, the data will be ready for sync.
Notice:

If the working time is less than 2 minute, there will be
no data saved

If the device power off during working, the data should
have been saved.
Sync data:

After the countdown, run App to sync data; If App has
already opened, go to History page to sync data.
You can also sync data later. The built-in memory can

11
store 4 sessions. The oldest will be overwritten by the
5th. Please sync data to your phone in time.
Notice: The built-in memory can store 4 sessions, up to 10
hours for each. It will start the next session automatically
after 10 hours monitoring.
3.7 Screen wake up / change display
During measurement, the screen will go off automatically for
saving power; you can press the side button to wake up the
screen or change display.
3.8 Bluetooth Connection
The device Bluetooth will be enabled automatically after it’s
turned on.
To establish a Bluetooth connection,
1) Power on the device.
2) Make sure the phone Bluetooth is enabled.
3) Run the App.
4) Allow the App to use Bluetooth.
Notice:
DO NOT PAIR in the settings of your smartphone.
3.9 Add a new device
For the initial use, you need to add a new device.
1) Turn on device, run App, select <BabyO2>;
2)
Follow the App instruction to add the new device.

12
3.10 App Dashboard
In App Dashboard, you can view:
Real-time oxygen Level, heart rate;
Near term trends of oxygen level, heart rate and motion.
PI (Perfusion Index). If too weak (being red), please
check if the sensor has been positioned and secured
properly.
Bluetooth signal. If too weak, place phone closer to the
device.
Device battery level
Reminder info
Help info
3.11 Audio reminder in Device
You can configure it in App-Settings when your device is
connected to App.
You can switch on or off the reminder.
You can adjust the volume of the reminder.
You can adjust the Threshold.
The reminder will stop when oxygen level recover, or you can
press the side button to stop it.
3.12 Audio reminder in App
You can configure it in App-Settings.
You can switch on or off the reminder.
You can adjust the Threshold.
The volume is same as your phone’s volume.
The Reminder works only when your phone stayed in
Dashboard and not locked.

13
The Reminder in Dashboard will be activated when the
oxygen level fall below the pre-set value (Threshold).
The Reminder will stop when the oxygen level recover. You
can press the Mute icon on Dashboard to mute.
3.13 View Report
In App->History,
Tap an item in the list, you can check the detailed report,
which includes analysis results and diagrams.
Slide an item to left, you can delete it.
3.14 App Offline Mode | Multiple Devices
If you enter App Offline Mode, you can view history data, in App
Settings->Select Device, you can select device if you have multiple
devices. In this Mode, device is not connected so you cannot sync
data or set device.
4 PC software
PC Software: O2 Insight Pro
Download from: www.getbabytone.com
Enter top menu: Support->PC Software
Install the software on windows (win 7/8/10) or Mac
OS(10.13 or above).
To use the software,
1) Turn on device, connect the device to PC USB port with
the supplied Cable. Don’t connect device to App when
you want to connect to PC Software.
2) Run the PC software, click the
Download
button to

14
download data from the device
With the PC software, you can view and print report, which
can also be exported as PDF or CSV files.
5 Maintenance
5.1 Time & Date
After connection with App, device time will sync from your
phone time automatically.
5.2 Cleaning
Clean the device with a soft, dry cloth with 75% alcohol.
Clear the wrap with water. Water temperature should be lower
than 104℉(40℃)
Clean the sensor carefully with cloth soaked 75% alcohol, if
it is dirty or dusty.
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.
6 Troubleshooting
Problem Possible Cause Possible Solution
No readings
on screen
The sensor is not
positioned and
secured properly
Check if the sensor has been
positioned and secured
properly
Baby is moving
frequently
It will recover when at rest
Device
does not
Battery may be low. Charge battery and try
again.

15
turn on or
no response Device might be
damaged.
Please contact your local
distributor.
The app
cannot find
the device
The Bluetooth of
your phone is off.
Turn on the Bluetooth in the
phone.
The device Bluetooth
is off.
Turn on device
The App is not
allowed to use
Bluetooth
Allow the App to use
Bluetooth
For Android,
Bluetooth cannot
work without location
permission
Allow location access
7 Specifications
Environmental Operating Storage
Temperature 5 to 40°C -25 to 55°C
Relative humidity
(noncondensing) 10% to 80% 10% to 93%
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 31g

16
(main unit with band and sensor)
Display OLED
Size 49×27×14 mm (main unit)
Battery 5Vdc, Rechargeable Lithium-polymer
Charge time 2 hours
Battery life
16 hours for typical use
Wireless Bluetooth 4.2 BLE
Oxygen level range 0% to 100%
Oxygen level
Accuracy (Arms) 70-100%:±2%, 0%-69%:Undefined
A functional tester or SpO2 simulator can be used to determine the
pulse rate accuracy.
Heart Rate range 20 to 250 bpm
Heart Rate accuracy ±2 bpm or ±2%, whichever is greater
Wavelength / Max
emission power
660nm/940nm, 0.8mW/1.2mW
SpO2 data update
period
1s
Reminder Triggered by low oxygen level
Recorded
parameters
Oxygen level, Heart Rate
Data storage
4sessions, up to 10 hours for each
Frequency range 2.402 – 2.480 GHz
Max RF power -5.15 dBm
Expected service life 5 years
Mobile App for iOS
iOS 9.0 or above,
iPhone 4s/ iPad 3 or above
Mobile App for
android
Android 5.0 or above,
with Bluetooth 4.2 BLE

17
8 Symbols
Symbol Description
Manufacturer
Date of manufacture
SN Serial number
Indicate separate collection for electrical
and electronic equipment (WEEE).
Follow Instructions for Use.
Type BF Applied Part
No alarm system
MRI unsafe. Presents hazards in all MR
environments as device contains strongly
ferromagnetic materials.
IP22 Resistant to liquid ingress
CE marking
Authorized representative in the European
community
This product complies with the rules and
regulations of the Federal Communication
Commission.

18
Symbol Description
Temperature limitation
Humidity limitation
Atmospheric pressure limitation

19
FCC Statement
FCC Warning:
FCC ID: 2ADXK-4728
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

20
condition without restriction.