viatom 4708 Pulse Oximeter Instruction Manual

4708 Pulse Oximeter
Instruction Manual

Introduction

Intended use

This Pulse Oximeter is intended to be used for measuring, displaying, and storing pulse oxygen saturation (SpO2), and 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, 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., an 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 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.

• 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.

Guide to Symbols

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).

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 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 low power promptly.

A full 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 a 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, the recording will be over after the countdown.
3. DATA Uploading. Run your phone to download data.

Start working

1. Wear the device on the index finger. Try to move the device along the forefinger to find out the best fit. Avoid being loose. Loose wearing causes inaccurate measures.
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 the 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. SpO2 measurement 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.

Stop working & Upload 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 be 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’s 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.

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 the device, run phone, select ;
2. Press the button on the side of the device

Smart Vibration by SpO2
When SpO2 drops below the preset value (threshold), the buzzer in the sensor will be activated. When SpO2 is restored, the sound will stop.

Smart Vibration by SpO2
When SpO2 drops below the preset value (threshold), the buzzer in the sensor will be activated. When SpO2 is restored, the sound will stop.

Smart Vibration by Pulse Rate
When your pulse frequency is higher than the upper limit or lower than the lower limit, the buzzer will be activated.

Maintenance

Time & Date
After connection with the 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 and then let it air dry.
• Do not use petrol, thinners, or similar solvent.
• Clean the SpO2 sensor carefully with a cloth soaked in 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

the battery and try again.
Device might be
damaged.| Please contact your local distributor.
Software exception| Press the side button for 8 seconds
Inaccurate
measured value| The device has not been placed for more than 30 minutes from the colder environment to the measuring environment.| Measurements should be taken before they are left in the measuring
environment for more than 30 minutes
The device has not been placed for more than  30 minutes from the warmer environment to the measuring environment.| Measurements should be taken before they are left in the measuring environment for more than 30 minutes

Specifications

A functional tester or Sp02 simulator can be used to determine the pulse rate accuracy.
Wavelength I Max emission power| 660nm/940nm, 0.8mW/1.2mW
SpO2 data averaging time| 8s
SpO2 data update period| 1s
Vibration source| low oxygen level;
high/low pulse rate
Recorded parameters| Oxygen level, Pulse Rate
Record interval| 4s
Data storage| 1 record, up to 4hours for each
Frequency range| 2.402 – 2.480 GHz
Max RF power| -10 dBm
Expected service life| 3 years

Declared Accuracy

The table below shows Arms values measured using the Pulse Oximeter 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 a subject from a clinical study in non-motion conditions.

Manufacturer: Shenzhen Viatom Technology Co., Ltd
ddress: 4E, 3#, Tingwei Industrial Park, Honglang
North 2nd Road, Baoan
District, Shenzhen, China
Website: www.welluehealth.com

MedNet GmbH
Borkstrasse 10 · 48163 Muenster · Germany
TEL: +49 251 32266-0 FAX: +49 251 32266-22

Model: PO6、PO6A
Version: A
©Copyright 2019 Shenzhen Viatom Technology Co., Ltd. All rights reserved.

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, 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.

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