Wearpulse Oxyfit Continuous Pulse Oximeter Fingertip User Guide

: June 13, 2024
: Wearpulse

Oxy fit
Fingertip Oxi meter
User Manual

Down load App
App name: Vi Health
iOS: App Store
Android: Google Play
Notice: If you have installed the App before, please update it to the latest version.

Introduction

Intended use

This product is intended to be used for measuring, displaying and storing of oxygen level (SpO2), heart rate of adults in home or healthcare facilities environment for sleep or daily use.

It’s not a medical device. This device is for Sports and Aviation use only and not intended for medical use.

Warnings and Cautions

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, 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 oxygen level probe on a finger with edema or fragile tissue.
Check the oxygen level sensor and cable before use. Do not use a damaged oxygen level sensor.
Check the oxygen level sensor application site every 6-8 hours to determine the positioning of the sensor and the circulation and skin sensitivity of the user. User sensitivity varies depending on medical status or skin condition. For users 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 oxygen level 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.
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 LEVEL.

Guide to Symbols

Symbol	Description

| Manufacturer

| Date of manufacture

| Serial number

| Indicates a medical device that is not to be disposed of as unsorted municipal waste.

| 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

| Resistant to liquid ingress

| This product complies with the rules and regulations of the Federal Communication Commission.

| Non-ionizing radiation.

| This product complies with verpackG.

| Temperature limitation

| Humidity limitation

| Atmospheric pressure limitation

Unpacking

Device
User Manual
Charging Cable

Overview

Using the Device

Charging

Charge the battery before using.
Connect the device to computer USB or USB charging adapter with USB cable.
After fully charged, the device will power off automatically.

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 it off.

Typical steps

START. Charge the battery. Wear the device to power on.
STOP. Take off the device, the recording will be over after the countdown.
DATA SYNC. After the countdown, run App to sync data. OR next time after you turn on the device, run App to sync.

Start working

) 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.
) Device will turn on automatically. After a few seconds, the device will begin to work.

Notice:

If the working time is less than 30 second, the data will not be saved.
Please avoid excessive motion.
Please avoid strong ambient light condition.

Stop working & sync data

Take off the device, the countdown will begin. (If the working time is less than 30 second, 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.
Sync data:

After the countdown, run App to sync data;
OR next time after you turn on the device, run App to sync.

Notice: The built-in memory can store up to 4 sessions of record. Each session can store up to 10 hours data, and the oldest session will be overwritten by the new one when the memory is full. Please upload data to your phone in time.

Screen Display

The screen is always on and displaying the measuring value during monitoring. You can press Power button to switch displaying time and battery level.

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 be 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,

Keep the device Bluetooth enabled.
Make sure the phone Bluetooth is enabled.
Run the App.

Notice: DO NOT PAIR in the settings of your smart device.

Reminder on Device

The device supports audible reminders which triggered by user-defined oxygen level or heart rate threshold.
You can setup the reminder threshold on App.

Screen Mode and Brightness

In App->Settings, you can set device screen mode during connection.
Screen Mode: Standard; Always-on.
You can also change screen brightness.

Maintenance

Time & Date

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

Cleaning

Use a soft cloth moistened with water or alcohol to clean the device surface

Troubleshooting

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 and hold the key for 8 seconds.
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
For Android, Bluetooth cannot work without location permission| Allow location access

For more information about Oxy fit, please visit: https://[iwearpulse.com/pages/faq-support](http://iwearpulse.com/pages/faq- support)

6. Specifications

Environmental	Operating	Storage
Temperature	5 to 40°C	-25 to 70°C

Relative humidity

(non-condensing)

70-80%:±3%

Heart rate range| 30 to 250 bpm
Heart rate accuracy| ±2 bpm or ±2%, whichever is greater
A functional tester or oxygen level simulator can be used to determine the heart rate accuracy.
Wavelength / Max emission power| 660nm/940nm,

0.8mW/1.2mW

Reminder source| low oxygen level;

high/low heart rate

FCC Statement

FCC Warning:
FCC ID: 2ADXK-4708

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.

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 Website: https://iwearpulse.com

Product name: Pulse Oxi meter Model: PO6

Version: A Date: March 28, 2023 PN: 255-06204-00