O2Ring S9 Wearable Oxygen Monitor User Manual

: June 26, 2024
: O2Ring

Table of Contents

O2Ring S9 Wearable Oxygen Monitor
Product Usage Instructions
5. Stop Working & Sync Data

O2Ring S9 Wearable Oxygen Monitor

Specifications

Product Name: O2RingTM
Type: Wearable Oxygen Monitor
Intended Use: Measure, display, and store pulse oxygen saturation and pulse rate of adults
Environment: Home or healthcare facilities for sleep or daily use
Compliance: FCC regulations, overpack
IP Rating: IP22 (Resistant to liquid ingress)
Warnings: Do not squeeze the sensor part or apply excessive force

Product Usage Instructions

1. Charging

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

2. Power On/Off

POWER ON
Wear the device, it will turn on automatically.
POWER OFF
The device turns off automatically shortly after you take it off.

3. Typical Steps

START: Charge the battery and wear the device to power on.
STOP: Take off the device; the recording will end after the countdown.
DATA SYNC: After the countdown, run the App to sync data; alternatively, the next time you turn on the device, run the App to sync.

4. Start Working

Wear the device on the thumb finger or index finger (as an option in case it’s too tight for the thumb).
Avoid loose wearing as it may cause inaccurate measurements.
Avoid using the middle finger; if too tight for the thumb or forefinger, try the little finger.
Avoid excessive motion and strong ambient light conditions.

5. Stop Working & Sync Data

Take off the device; a 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 recording will resume. After the countdown, the data will be saved in the device and ready to sync.

Sync Data
After the countdown, run the App to sync data; alternatively, the next time you turn on the device, run the App to sync.

Notice
The built-in memory can store 4 sessions. The oldest will be overwritten by the 5th. Please sync data to your phone promptly.

1. Introduction
1.1.Intended use
This product is intended to be used for measuring, displaying, and storing pulse oxygen saturation (SpO2), and pulse rate of adults in home or healthcare facilities environments for sleep or daily use. Notice: This product is intended for sports or aviation use only. It should not be used to directly diagnose or treat any medical condition.
1.2.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, 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.
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.
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.

Guide to Symbols

| | Symbol| Description
---|---
| Manufacturer
| Date of manufacture
SN| 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 is unsafe. Presents hazards in all MR environments as the device contains strongly ferromagnetic materials.

IP22	Resistant to liquid ingress
This product complies with the rules and regulations of the Federal

1.4.Unpacking

Device
User Manual
Data/Charging Cable

2. Overview

3. Using the Device

3.1.Charging

Charge the battery before using.
Connect the device to the computer USB or USB charging adapter with a 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 after you take it off.

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

3.4.Start working

Wear the device on the thumb finger, and index finger as an option in case of too tight for the thumb. Try to move the device along the forefinger to find the best fit. Avoid being loose. Loose wearing causes inaccurate measurements.
The device will turn on automatically. After a few seconds, the device will begin to monitor.

Notice:

Keep snug enough, loose wearing may cause inaccurate readings.
DO NOT use the middle finger; if too tight for the thumb or forefinger, try the little finger.
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.

3.5.Stop working & sync 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 have been saved in the device and ready to sync.
Sync data:

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

Notice:
The built-in memory can store 4 sessions. The oldest will be overwritten by the 5th. Please sync data to your phone in time.
3.6.Screen Wake up
The screen will go off automatically for saving power in Standard Mode; you can touch the key on top to wake up the screen.
3.7.How to Check Battery
Touch the key on top, you can switch the display between readings and battery.
3.8.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, finger is too cold; Usually, the readings will recover in a few seconds when at rest.

3.9.Download App
App name

ViHealth iOS
App Store Android
Google Play

Compatibility
The device is compatible with iOS versions 9.0+ and Android versions 5.0+. Please Refer to the ViHealth app manual for more details.
3.10.Bluetooth Connection
The device is compatible with iOS versions 9.0+ and Android versions 5.0+. Please Refer to the ViHealth app manual for more details.
3.10.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’s Bluetooth is enabled.
Run the App.

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

4. PC software
PC Software: O2 Insight Pro
Download from:
https://getwellue.com/pages/pc-software Install the software on Windows(win 7/8/10) or MacOS(10.15 or above).
Install the software on the PC:

Turn on the device, and connect the device to the PC USB port with the supplied Data Cable (it’s different from the universal USB cable).
Run the PC software, and click the Download button to download data from the device.
With the PC software, you can view and print sleep reports, which can also be exported as PDF or CSV files.

Note:
while the device is being connected to the app, it can’t connect to PC software.

5. Maintenance

5.1.Time & Date
After connection with the App, device time will sync from your phone time automatically.
5.2.Cleaning
Use a soft cloth moistened with water or alcohol to clean the device’s surface.

1. Troubleshooting

Problem	Possible Cause	Possible Solution
The device does not turn on or no response	The battery may be low.	Charge

the battery and try again.
The device might be damaged.| Please contact your local distributor.
Software exception| Keep the device in charging, touch 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 a location

permission

| Allow location access
Only one Light Emitter on the ring

turns red.

| This is normal, the O2Ring only has one light emitter.| No need to worry about it.

For more information about O2RIng, please visit: https://getwellue.com/pages/faqs

1. Specifications ****

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

70°C

Relative humidity (non-condensing)| 10% to 95%| 10% to

95%

Barometric| 700 to 1060hPa| 700 to 1060hPa
Protection against electric shock| Internally powered equipment
Degree protection against electrical

shock

| ****

Type BF

Electro- magnetic

compatibility

| Group I, Class B
Degree of dust &

water resistance

range

| 70% to 99%
SpO2 Accuracy

(Arms)

| 80- 99 %: ±2%, 70-79%: ±3%
Pulse Rate Range| 30 to 250 bpm
Pulse Rate Accuracy| ±2 bpm or ±2%, whichever is greater
Vibration source| low oxygen level;

high/low pulse rate

Recorded

parameters

| Oxygen level, Pulse Rate,

motion

Data storage| 4 sessions, up to 10 hours for each
Mobile App for iOS| iOS 9.0 or above,

iPhone 4s/ iPad 3 or above

Mobile App for Android| Android 5.0 or above, with Bluetooth 4.0 BLE

8. Appendix EMC
The equipment meets the requirements of IEC 60601-1-2:2014.

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 is suitable for use in all establishments, including domestic establishments and those directly network that supply buildings used for domestic purposes.
Harmonic emissions

IEC 61000-3-2

|

N/A

Voltage fluctuations/flicker emissions

IEC 61000-3-3

|

N/A

Table 2

Guidance and manufacturer’s declaration-electromagnetic emission

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximeter should assure

that it is used in such an environment.

Immunity test

| IEC 60601 test level| Complia nice level| Electromagnetic environment

-guidance

Electrostatic discharge(ESD

)

IEC 61000-4-2

|

±8 kV contact

±15k V air

|

±8 kV

contact

±15k V

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 IEC 61000-4-4| ±2k V for power Supply lines

±1 kV for

input/output lines

|

N/A

|

N/A

Surge

IEC 61000-4-5

| ±1k V line (s) to line(s)

±2k V line(s) to

earth

|

N/A

|

N/A

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

| <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 5 s

|

N/A

|

N/A

Power frequency (50Hz/60Hz)

magnetic field IEC 61000-4-8

|

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 before the application of

the test level.

| | 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 ensure

that it is used in such an electromagnetic environment.

Immune ty test| IEC 60601

test level

80 MHz to

| 3 V/m| d= 1.2 P
Radiate| 2.5 GHz| | d= 1.2 P 80MHz to 800MHz
d RF

IEC 6100

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 broadcasts, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an 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 of 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 the transmitter

W(Watts)

| Separation distance according to frequency

of transmitter M(Meters)

150k Hz 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 meters (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.

1. FCC Statement

FCC Warning:

FCC ID: 2ADXK-S9

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, 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.

Manufacturer: Shenzhen Viatom Technology Co., Ltd. Address: 4E, Building 3, Tingwei Industrial Park No. 6 Liufang Road, Block 67 Xin’an Street, Baoan District Shenzhen 518101 Guangdong China

Contact us: [email protected] Website: www.getwellue.com

Product name:

Pulse Oximeter
Date: Mar.22, 2024
PN: 255-07509- 00

Frequently Asked Questions (FAQ)

Q: Can this device be used for medical diagnosis or treatment?
A: No, this product is intended for sports or aviation use only and should not be used to diagnose or treat any medical condition.

Q: How many sessions can the built-in memory store?
A: The built-in memory can store up to 4 sessions. The oldest session will be overwritten by the 5th session.