WELLUE PO6 Digital Finger Pulse Monitor Oximeter Guide

WELLUE PO6 Digital Finger Pulse Monitor Oximeter Guide

Introduction

Intended use
This Pulse Oximeter is intended to be used for measuring, displaying, and storing pulse oxygen saturation (SpO2), the 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 an 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 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 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 based on 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.
• The biocompatibility testing has been performed on the materials in contact with the person by 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.

Guide to Symbol

Symbol	Description
	Type BF-Applied Part
	Manufacturer
	Date of manufacture
	Authorized Representative in the European Community
	Follow Instructions for Use.
	MRI is unsafe. Presents hazards in all MR environments as the device contains strongly ferromagnetic materials.
	Protected against spraying water and against access to hazardous parts with a tool, per IEC60529.
	Serial number
	No alarm system
	Temperature limitation

	Humidity limitation
	Atmospheric pressure limitation
	Indicate separate collection for electrical and electronic equipment (WEEE).

Unpacking

• Device
• User Manual
• Charging Cable

Overview

Name: Pulse Oximeter
Model: PO6，PO6A
Model and Configuration see the table below

Using the Device

Charging
Use the USB cable to charge the product. Connect the USB cable to a USB charger or 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 full charge will take 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 moment after you take off the sensor

Typical steps

1. START. Charge the battery. Wear the device to power on.
2. STOP. Take off the device, therecordingwillbe over after the countdown.
3. DATA Uploading. Run your phone to download data.

Start working

1. Wear the device on your index finger. Try to move the device along the forefinger to find the best fit. Avoid being loose. Loosewearing causes inaccurate measurements.
2. The device will turn on automatically. After a few seconds, the device will begin to work.

Notice:

• If the working time is less than 2 minutes, the data will not be saved.
• Please avoid excessive motion.
• Please avoid strong ambient light conditions.

SpO2 measurement principle:
The Pulse Oximeter is a lightweight, portable health oximeter for use in the home or healthcare facilities. SpO2measurementtechnology is based on the developed photoelectron method, the circuit design and calculation software was developed by Shenzhen ViatomTechnologyCo., Ltd. The SpO2 sensor receives the optical signal from the red light and infrared light through the finger.

Insert the finger into the theoximeter, there are 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 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 the PR waveform.

Stop working & Upload the data

Take off the device, the countdown will begin. (If the working time is less than 2 minutes, 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 1 record. The oldest will be overwritten by the 2nd. Please upload data to your phone in time.

How to Check Battery
Press the side button, you can switch the display between readings and battery.

Unavailable Symbol

When this symbol displays on the device screen, it indicates the readings are unavailable right now. It may caused by:

• Excessive movement;
• Poor signal, the 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’s Bluetooth is enabled.

Maintenance

Time & Date
After connection with the phone, device time will be uploaded from your phone time automatically.

Cleaning
The device can be repeatedly used. Please clean before reuse as follows:

• Clean the device with a soft, dry cloth with 70% alcohol, and then let it air dry.
• Do not use petrol, thinners, or similar solvents.
• Clean the SpO2 sensor carefully with a cloth soaked with 70% alcohol 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.

Troubleshooting

Specifications

Declared Accuracy
The table below shows Arm values measured using the PulseOximeter in a clinical study in non-motion conditions. Accuracy Summary by Decade

This graph shows plots of the error (SpO2 –SaO2) by SaO2 using the Pulse Oximeter with a linear regression fit and upper 95% and lower 95% limits of agreement. Each sample data point is identified by subject from a clinical study in non-motion conditions.

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: (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, under 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 by 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 the receiver.
• Connect the equipment to 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.

REFERENCE LINK

https://www.viatomtech.com/po6