viatom PO2 Wearable Oximeter O2 Ring Instructions

viatom PO2 Wearable Oximeter O2 Ring

Introduction

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.

Contraindications
No contraindications.

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., an oxygen-enriched environment).
• Never submerge the device in water or other liquids.
•  Do not clean the device with acetone or other volatile
• 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 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.
•  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.

**Guide to Symbols

**

Unpacking

•  Device
•  User Manual
•  Data/ Charging Cable

Overview

Name: Pulse Oximeter Model: PO2

Touch Switch:
Wake up the screen and switch the interface. Backlit Screen:
Show SpO2 value and pulse rate value .

USB Charging Port:
Can be charged and data transmission.

Sensor:
The device turns on/off automatically in a moment after you take on/off the sensor.

Using the Device

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.

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.

Typical steps

1.  STOP. Take off the device, the recording will be over after the countdown.
2.  DATA Uploading. Run your phone to download data.

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. SpO2 measurement 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 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.

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.

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.

How to Check Battery
Touch the key on top, you can switch display between readings and battery.

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.

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.

Add a New Device
For the initial use, you need to add a new device. 1) Turn on device, run phone, select ; Touch the key on top of device.

Smart Vibration by SpO2
The vibrator in the sensor will be activated when the SpO2 fall below the pre- set value (Threshold). The vibration will stop when the SpO2 recover.

Smart Vibration by Pulse Rate
When your pulse rate is above the Upper Threshold or below the Lower Threshold, vibration will be activated.

Maintenance

Time & Date

After connection with phone, device time will upload from your phone time automatically.

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.

Specifications

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
---|---
SpO 2 data **averaging time| 8s
SpO 2 data update **period| 1s
Vibration source| low oxygen level;

high/low pulse rate

Recorded parameters| Oxygen level, Pulse Rate
Record interval| 4s
Data storage| 4 records, up to 10 hours for each
Frequency range| 2.402 – 2.480 GHz
Max RF power| -10 dBm
Expected service

life

| 3 years

FCC Warning:

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:

• This device may not cause harmful interference, and

• 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.

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