viatom PO5 BabyO2 Infant Pediatric Pulse Oximeter User Manual

BabyO2 TM
Pulse Oximeter User Manual
Contact us: service@getbabytone.com
Website: www.welluehealth.com

 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 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 a strong impact. The device and accessories are provided non-sterile.
• Do not place this device in pressure vessels or gas sterilization devices.
• 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 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 the 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:
• Connect the sensor and device. Soft wraps:
• Secure the sensor and the device. Data/Charging Cable:
• Can be charged and data transmission.

1. Using the device and App
   3.1 Download App App name:
   VicHealth 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 the USB of the 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 if not connected to the phone for 2 minutes.
• Even with the sensor cable connected, it will power off automatically if not 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

Secure the sensor(For newborns)
A. Place the foot wrap on the foot (either foot works), with the sensor part running on the outside edge of 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) 7
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.
If the screen displays a “poor signal”, please check if the sensor has been positioned and secured properly.
When the above symbol displays on the 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
• The 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 the App will be illustrated later)
Notice:

• If the working time is less than 2 minutes, the data will not be saved.
• The motion may cause readings unavailable. Readings recover very soon at rest.
• Please avoid strong ambient light conditions.

SpO2 measurement principle:
The Pulse Oximeter is a lightweight, portable health oximeter for use in the home or in healthcare facilities. SpOmeasurement technology is based on the 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 is two emitting tubes (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 the 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 the above peak intervals of the 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:

1. If the working time is less than 2 minutes, there will be no data saved
2. If the device is powered off during working, the data should have been saved.

Sync data:

1. After the countdown, run App to sync data; If App has already opened, go to the History page to sync data.
2. You can also sync data later. The built-in memory can store 4 sessions. The oldest will be overwritten by the 5th. Please sync data to your phone in time.
3. 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 of monitoring.

3.7 Screen wakes 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 the display.
3.8 Bluetooth Connection
The device’s 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’s 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 the device, run App, select ;
2. Follow the App instruction to add the new device.

3.10 App Dashboard
In-App Dashboard, you can view

• Real-time oxygen Levels, 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 the 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 the oxygen level recovers, 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 the same as your phone’s volume. The Reminder works only when your phone stayed in Dashboard and is not locked.
The Reminder in the Dashboard will be activated when the oxygen level falls below the pre-set value (Threshold).
The Reminder will stop when the oxygen level recovers. You can press the Mute icon on the 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 historical data, in App Settings->Select Device, you can select a device if you have multiple devices. In this Mode, the device is not connected so you cannot sync data or a set device.

**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 the device, connect the device to PC USB port with the supplied Cable. Don’t connect the device to App when you want to connect to PC Software.
2. Run the PC software, click the Download button to download data from the device With the PC software, you can view and print reports, which can also be exported as PDF or CSV files.

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 a cloth soaked with 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.

Troubleshooting

Check if the sensor has been positioned and secured properly
The baby is moving frequently| It will recover when at rest
Device does not| The battery may be low.| Charge the battery and try again.
turn on or no response| The device might be damaged.| Please contact your local distributor.
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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 a location
permission| Allow location access

Specifications

A functional tester or Sp02 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| 660ntn/940nm, 0.8mW/1.2mW
Sp02 data update period| is
Reminder| Triggered by low oxygen level
Recorded parameters| Oxygen level, Heart Rate
Data storage| 4 sessions, 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

Symbols

strongly ferromagnetic materials.

| 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.
| Temperature limitation
| Humidity limitation
| Atmospheric pressure limitation

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 requirements. The device can be used in portable exposure conditions without restriction.

Shenzhen Viatom Technology Co., Ltd
4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road,
Block 67, Xin’an Street, Baoan District, Shenzhen, 518101,
Guangdong, China
www.welluehealth.com

MedNet EC-REP GmbH
Borkstraße 10
48163 Münster Germany

0197
Product name: Pulse Oximeter
Model: PO5, PO5-1, PO5-2, PO5-3
Version: A
Date: Nov. 24, 2021

Documents / Resources

| viatom PO5 BabyO2 Infant Pediatric Pulse Oximeter [pdf] User Manual
4728, 2ADXK-4728, 2ADXK4728, PO5, PO5-1, PO5-2, PO5-3, PO5 BabyO2 Infant Pediatric Pulse Oximeter, PO5 BabyO2, Infant Pediatric Pulse Oximeter
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References

• Baby Sleep Monitor, Pediatric Pulse Oximeter | Babytone

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