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 (SpO
2
),
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 SpO
2
probe on a finger with edema or
fragile tissue.
 Check the SpO
2
sensor and cable before use. Do not
use a damaged SpO
2
sensor.
 Check the SpO
2
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 SpO
2
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 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.
SpO
2
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
No.
Model
Appearance
color
1
PO6
Blue
2
PO6A
Gray

Summary

Instruction for Use

Intended Use

Device is for measuring, displaying, and storing SpO2, pulse rate of adults in home or healthcare.

Contraindications

No contraindications are listed for the use of this device.

Warnings and Cautions

Important safety information, warnings, and precautions for using the pulse oximeter.

Guide to Symbols

Explanation of symbols used on the device and in the manual.

Unpacking

Contents of the package: device, user manual, and charging cable.

Overview and Usage

Device Overview

Details about the Pulse Oximeter, its models, and configuration.

Using the Device

Instructions on how to use the pulse oximeter, including charging and operation.

Charging the Device

Instructions for charging the pulse oximeter using a USB cable.

Powering On and Off

How to turn the pulse oximeter on and off manually and automatically.

Typical Operation Steps

Step-by-step guide for charging, wearing, and uploading data from the device.

Starting Work

Instructions on how to wear the device correctly for accurate measurements.

SpO2 Measurement Principle

Explanation of the photoelectric method used for SpO2 measurement.

Stopping Work and Data Upload

How to stop the device, save data, and upload it to a phone.

Checking Battery Status

Instructions on how to check the device's battery status.

Unavailable Symbol Explanation

Explanation of the symbol indicating unavailable readings and its causes.

Bluetooth Connection

Instructions for pairing the device with a phone via Bluetooth.

Smart Vibration Alerts

Details on SpO2 and pulse rate threshold alerts via vibration.

Maintenance and Troubleshooting

Time and Date Synchronization

How the device time synchronizes with a connected phone.

Cleaning Instructions

Proper methods for cleaning the pulse oximeter for reuse.

Troubleshooting Common Issues

Solutions for problems like device not turning on or inaccurate measurements.

Specifications and Accuracy

Device Specifications

Technical details including environmental, electrical, and physical characteristics.

Declared Accuracy

Summary of SpO2 accuracy values from clinical studies.

Overview

1. Pulse Oximeter Description
   1. Function Description
   2. Usage Features
   3. Maintenance Features

Pulse Oximeter Description

This document describes the Pulse Oximeter, a lightweight, portable health device designed for measuring, displaying, and storing pulse oxygen saturation (SpO2) and pulse rate in adults within home or healthcare facility environments.

Function Description

The Pulse Oximeter utilizes a developed photoelectron method for SpO2 measurement. It incorporates a circuit design and calculation software developed by Shenzhen Viatom Technology Co., Ltd. The device features an SpO2 sensor that receives optical signals from red and infrared light transmitted through the finger. Two emitting tubes (red light diodes and infrared diodes) are located on the inner upside of the sensor, while a receiving end is on the inner downside. The Microcontroller Unit (MCU) processes the pulse signal, obtains frequency signals by counting, and ultimately determines the measured SpO2 value. The pulse rate (PR) is calculated by averaging the peak intervals of the PR waveform.

The device is calibrated to display functional oxygen saturation. It includes a smart vibration feature that activates a buzzer if SpO2 drops below a preset threshold or if the pulse frequency exceeds or falls below its set limits. The buzzer will stop once the SpO2 or pulse rate returns to normal ranges.

Usage Features

Power On/Off: The device powers on automatically when worn and turns off automatically a moment after it is removed from the sensor.

Charging: The Pulse Oximeter is charged via a USB cable connected to a USB charger or PC. A battery logo flashes on the device during charging. A low power prompt will appear on the display screen when the battery is low. A full charge typically takes 2-3 hours, after which the device automatically powers off. It's important to note that the device cannot be used during charging. If a third-party charging adapter (Class II) is used, it must comply with IEC60950 or IEC60601-1 standards.

Wearing and Operation: To begin, charge the battery and then wear the device on the index finger. Users should try to move the device along the forefinger to find the best fit, avoiding loose wearing, which can lead to inaccurate measurements. The device will automatically turn on and begin working after a few seconds.

Data Storage and Upload: The device has a built-in memory that can store one record. The oldest record will be overwritten by the next one, so it's crucial to upload data to a phone promptly. Data uploading is initiated by running the phone application after the device has completed its recording countdown. If the working time is less than 2 minutes, data will not be saved.

Bluetooth Connection: The device's Bluetooth is automatically enabled when powered on. To establish a connection, ensure both the device and the phone's Bluetooth are enabled. For initial use, a new device needs to be added by turning on the device, running the phone application, selecting "Oxyfit," and pressing the button on the side of the device. Users are advised not to pair the device directly in the phone's Bluetooth settings.

Checking Battery: The side button allows users to switch the display between readings and battery status.

Unavailable Symbol: If an unavailable symbol appears on the screen, it indicates that readings are currently unavailable. This can be caused by excessive movement, poor signal, or a cold finger. Readings usually recover within a few seconds once the user is at rest.

Warnings and Cautions:

• Avoid squeezing the sensor or applying excessive force.
• Do not use the device during MRI examinations or with a defibrillator.
• Store the device away from direct sunlight, lint, dust, high temperatures, moisture, heavy contamination, water/fire sources, or strong electromagnetic influences.
• Do not use in combustible or oxygen-enriched environments.
• Never submerge the device in water or other liquids.
• Do not clean with acetone or other volatile solutions.
• Avoid dropping the device or subjecting it to strong impact.
• The device and accessories are non-sterile.
• Do not place the device in pressure vessels or gas sterilization devices.
• Do not dismantle the device, as this can cause damage, malfunctions, or impede operation.
• Consult a doctor immediately if acute disease symptoms are experienced.
• Do not self-diagnose or self-medicate based on this device without consulting a doctor, especially regarding new medication or changes to existing medication.
• Use only specified cables, sensors, and accessories.
• Prolonged continuous monitoring may increase the risk of skin irritation, reddening, blistering, or burns. Check the wearing position every 6-8 hours, and more frequently for patients with poor peripheral blood circulation or sensitive skin.
• Do not open the device cover without authorization.
• 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 sensor.
• The functional tester cannot assess the accuracy of the SpO2 sensor or device.
• The device has no alarm system.
• Follow local laws and regulations for disposal.
• Do not maintain the device while charging.
• Keep the cable away from children to prevent strangulation.
• Keep the device out of reach of pets, pests, and children.
• Avoid excessive motion and strong ambient light conditions during use.

Maintenance Features

Time & Date: After connecting with a phone, the device's time will automatically synchronize with the phone's time.

Cleaning: The device is reusable and should be cleaned before each reuse.

• Clean the device with a soft, dry cloth soaked in 70% alcohol and allow it to air dry.
• Do not use petrol, thinners, or similar solvents.
• Clean the SpO2 sensor carefully with a cloth soaked in 70% alcohol and allow it to air dry.
• The device is a non-sterile medical device and does not contain sterile or degradable components, thus it is not subject to shelf life requirements.

Troubleshooting:

• If the device does not turn on or respond, check if the battery is low (charge it) or if the device is damaged (contact distributor).
• For inaccurate measurements, ensure the device has been acclimated to the measuring environment for at least 30 minutes if moved from a colder or warmer environment. If software exception is suspected, press the side button for 8 seconds.

The biocompatibility testing has been performed on the materials in contact with the person in accordance with ISO10993.

Wellue PO6 Specifications

General

Measurement Range (SpO2)	70% - 100%
Measurement Range (PR)	30 - 250 bpm
Accuracy (SpO2)	±2% (70% - 100%)
Display Type	OLED
Dimensions	62 x 33 x 13 mm
Resolution (SpO2)	1%
Resolution (PR)	1 bpm
Bluetooth	Yes
Compatibility	iOS and Android
Type	Pulse Oximeter
PR Accuracy	±2 bpm or ±2%, whichever is greater
Weight (without strap)	30g
Battery Type	Rechargeable lithium battery