Oxyfit M35058EN ViHealth App User Manual

M35058EN ViHealth App
User Manual

Download App
Download the ViHealth App from iOS App Store or Google Play Store, or scan the QR code.
Notice: if you have installed the App before, please update it to the latest version.

http://qr.hotlnk.cn/79838280684

Introduction

1.1. Intended use
This product 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.

1.2.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, 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 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.
• 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.

1.3. Guide to Symbols

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.
IP22| Resistant to liquid ingress
| CE marking
| Authorized representative in the European community
| UKCA marking
| Authorized Representative in the United Kingdom
| Non-ionizing radiation
| Our products and packaging can be recycled, don’t throw them away!
Find where to drop them off on the www.quefairedemesdechets.fr site (Only applicable for French market).

1.4. Unpacking

• Device
• User Manual
• Charging Cable

Overview

Using the Device

3.1.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.

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 afteryou take it off.

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

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 30 seconds, the data will not be saved.
• Please avoid excessive motion.
• Please avoid strong ambient light condition.

3.5.Stop working & sync data
Take off the device, the countdown will begin. (If the working time is less than 30 seconds, 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 1 hour 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.

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

3.7. 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.

3.8.Bluetooth Connection
The device Bluetooth will be enabled automatically after it’s turned on.
To establish a Bluetooth connection,

1. Keep the device on.
2. Make sure the phone Bluetooth is enabled.
3. Run the App and follow the on-screen instructions.
   Notice: DO NOT PAIR in the settings of your smart device.

3.9.Reminder on Device
The device supports audible reminders triggered by user-defined SpO2 or Heart rate threshold.
You can setup the reminder threshold on App.

Maintenance

4.1. Time & Date
After connection with App, device time will sync from your phone time automatically.

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

Troubleshooting

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 Oxyfit, please visit: https://getwellue.com/pages/faqs

Specifications

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

Appendix EMC

The equipment meets the requirements of IEC 60601-1-2:2014.
Table 1

Guidance and manufacturer’s declaration-electromagnetic emission

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximeter should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment-guidance
RF emissions CISPR 11| Group 1| The Pulse Oximeter uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The Pulse Oximeter suitable for use in all establishments, including domestic establishments and those directly network that supplies buildings used for domestic purposes.
Harmonic emissions IEC61000-3-2| N/A
Voltage fluctuations/flicker emissions IEC61000-3-3| N/A

Table 2
Guidance and manufacturer’s declaration-electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the Pulse Oximeter should assure that it is used in such an environment.

Immunity test| IEC60601 test level| Compliance level| Electromagnetic environment-guidance
---|---|---|---
Electrostatic discharge(ESD) IEC61000-4-2| ±8 kV contact ±15kV air| ±8 kV contact ±15kV air| Floors should be wood, concrete or ceramic tile. if floors are covered with synthetic material, the relative humidity should be at least 30%
Electrical fast transient/ burst IEC61000-4-4| ±2kV for power Supply lines
±1 kV for input/output lines| N/A| N/A
Surge IEC 61000-4-5| ±1kV line (s) to line(s)
±2kV line(s) to earth| N/A| N/A
Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11| <5% UT
(>95% dip in UT) for 0.5 cycle
<40% UT
(60% dip in UT) for 5 cycles
<70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5s| N/A| N/A
Power frequency (50Hz/60Hz) magnetic field IEC61000-4-8| 3A/m| 3A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application othe test level.

Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of The Pulse Oximeter should assure that it is used in such an electromagnetic environment.

Immunity test| IEC60601 test level| Complianc e level| Electromagnetic environmentguidance
---|---|---|---
Conducted RF IEC61000-4-6
Radiated RF IEC61000-4-3| 3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz| N/A
3 V/m| Portable and mobile RF communications equipment should be used no closer to any part of The Pulse Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d=1.2 √P
d=1.2 √P 80MHz to 800MHz
d=2.3 √P 800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a: Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which The Pulse Oximeter is used exceeds the applicable RF compliance level above, The Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating The Pulse Oximeter.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Table 4

Recommended separation distances between portable and mobile RF communication the equipment
The Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of The Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W(Watts)| Separation distance according to   frequency of transmitter M(Meters)
---|---
150kHz to 80MHz d=1.2 √ P| 80MHz to 800MHz d=1.2 √ P| 80MHz to 2,5GHz d=2.3 √ P
0,01| N/A| 0.12| 0.23
0,1| N/A| 0.38| 0.73
1| N/A| 1.2| 2.3
10| N/A| 3.8| 7.3
100| N/A| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Copyright
This manual is written by our company and all rights reserved. Without our company’s prior written consent, no part of this manual may be reproduced or copied in any form or method.

Illustration
All illustrations provided in this manual are for reference only, and the settings or data in the illustrations may not be exactly the same as the actual display you see on the product.

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 www.viatomtech.com

MedNet EC-REP GmbH
Borkstrasse 10, 48163 Muenster,
Germany
Tel: +49 251 32266-0 Fax: +49 251 32266-22
Email: contact@mednet-ecrep.com

MediMap Ltd
2 The Drift, Thurston, Suffolk IP31 3RT, United Kingdom
Tel: +49 251 32266-0 Fax: +49 251 32266-22
Email: contact@mednet-ecrep.com

Australia Sponsor: SHARE INFO PTY LTD
Add: 4 Allnutt ct, Cheltenham, melbourne, VIC 3192, Austrilia

Product name: Pulse Oximeter
Model: PO6
Version: D Date: Jun. 28, 2023
PN: 255-04060-CE

References

• ecrep.com
• Que Faire de mes Déchets ? Découvrez les solutions pour tous vos déchets et nos conseils pour en produire moins.
• Que Faire de mes Déchets ? Découvrez les solutions pour tous vos déchets et nos conseils pour en produire moins.
• Home Wearable Medical Devices: Pulse Oximeter Manufacturer | Viatom
• Products FAQs | Wellue Support

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