OSRMB-01 Ninenovo Sleep System User Manual

OSRMB-01 Ninenovo Sleep System

Introduction

Intended Use
The Ninenovo Sleep System is a wearable device intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating moderate to severe sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in clinical and home settings under the direction of a Healthcare Professional (HCP).

Warnings and Cautionary Advice

• Before using this product, it should be ensured that it is in normal working condition and operating environment. For more accurate measurement, this product should be used in a quiet and comfortable environment.
• Do not use this product immediately when transitioning from a cold environment to a warm and humid location. If this product is splashed or has water condensation, stop the operation.
• Do not use sharp objects to operate this product.
• Do not use this device during an MRI examination.
• 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.
• This product is suitable for adults aged 18 and above.
• Do not place this device in pressure vessels or gas sterilization devices.
• Do not place the device in contact with children or pets, to avoid children or pets using the device as a toy and accidentally swallowing dry batteries, resulting in suffocation and other dangerous situations.
• This product may not be suitable for everyone. If satisfactory measurements cannot be achieved, please give up using it.
• Data averaging and signal processing on SpO2. Delay in displaying and transmitting data values. The measurement data update cycle is less than 30 seconds, and when signal attenuation, weak perfusion, or other interference occurs, it will lead to an increase in the time for taking the dynamic mean, which depends on the pulse rate value.
• The service life of this product is 5 years, and the production date can be found on the label.
• This product does not provide alarm functions for blood oxygen saturation and pulse rate exceeding limits and is not suitable for places that require alarm functions for measuring values exceeding limits.
• Do not drop this device or subject it to strong impact, such as falling on the floor, to avoid damaging the sensor and affecting the performance of the device.
• Do not dismantle the device, as this could cause damage or malfunctions or impede the operation of the device.
• This device is not intended for use by people (including children) with restricted physical, sensory, or mental skills or a lack of experience and/or a lack of knowledge unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device.
• The volume recording waveform has not been normalized and serves as an indicator of signal incompleteness. When the waveform does not tend to be smooth and stable, the accuracy of the measured value may decrease. When the waveform tends to be smooth and stable, the measured value read is the optimal value, and the waveform at this time is also the most standard. Our company can provide circuit diagrams, component lists, annotation, and other information as required so that qualified technical personnel of users can repair product components designated by our company that can be repaired.
• The test part should not have external colorants, such as nail polish, colorants, or colored skin care products, otherwise, the measurement will be affected.
• Fingers should be placed correctly (refer to 2.4 of this manual). Improper placement or contact with sensors can affect the measurement.
• The light between the photoelectric receiving tube and the light emitting tube of this product must pass through the small arterial bed of the tested person; There should be no light barriers such as adhesive tape in the area where the light path passes through, otherwise, it may cause inaccurate measurement values.
• Excessive ambient light can affect measurements, such as surgical lamps (especially aviation light sources), bilirubin lamps, fluorescent lamps, infrared heating lamps, and direct sunlight. To prevent interference from ambient light, it is essential to place the sensor properly and cover the sensor area with opaque materials.
• Excessive movement (active or passive) or intense activity of the subject can affect measurement accuracy.
• Do not place the sensor on limbs with blood pressure cuffs, arterial catheters, or intraluminal pipelines. This product does not have anti defibrillation function, and measurement values may be inaccurate during and shortly after defibrillation.
• This product undergoes pre-factory calibration.
• This product has been calibrated to display functional blood oxygen saturation.
• Do not place the device in direct sunlight.
• 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.
• Vital signs measurements, such as those taken with this device, cannot identify all diseases. Regardless of the measurement taken using this device, you should 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.

Model

Unpacking

• Ninenovo Sleep System(Main Unit) × 1
• Smart Charging Case × 1
• Charging cable × 1
• User Manual × 1

Using the Device

Charge your ring to activate it before your first use
We recommend that charge your ring for 60 minutes or until the power level is greater than 80% for the first use. Remove the ring from the box and place it in the charging case. The blue light will begin flashing within 5 seconds and will automatically activate the ring and enter the waiting binding state.

The ring must be activated before it can be used properly. The ring must be positioned properly on the charging case for the contacts to line up. It will only fit in one position. See Figure 1 Do NOT force it into the case in a different position. When charging, do not place the product in a place where it is difficult to disconnect the adapter Requirements for charging adapter: comply with the requirements of IEC 60601-1 standard, with output parameters of 5.0V dc, 0.5A.

Connect the ring with the app
Open the Ninenovo Health APP, click the “Me” page, and select “Bind the device”.

Note
Bluetooth must be enabled on your device. Please keep the ring within one meter/yard of your mobile device for them to bind.

Wear the ring correctly
Position the ring so that the sensors fit snugly on the base of your finger. It must remain in this position to optimize data collection although you can switch it between different fingers if needed.

Note

• We recommend that you wear the ring on your index finger.
• If that is not the best fit for you, wear it on the finger you selected the size for.
• If the ring shifts during wear, please adjust it back into position.

OSAHS monitoring

• Click the “Research” page on the bottom of the app， at the next page Click ―Strat Monitoring‖,
• Please ensure that the ring is well connected and your phone has a sufficient battery, Click ―Next;
• Please start monitoring before you go to sleep and make sure the app remains open, Click ―Next;
• Slide to stop Monitoring when you wake up, and wait for the report to be generated; Click ―Start Monitoring‖;
• When monitoring time is up, swipe right to the end。

Check health data &battery information
You can sync your data from your ring to the Ninenovo Health App at any time to check your health data and your battery status. Your ring will retain data for 5 to 7 days if it is not synced. It will automatically sync when you hold your mobile device while the app is open as long as your Bluetooth is enabled.

Note

• You can check the charging status of the ring on your phone. Click the “Me” page on the bottom right of the app,
• you can see the remaining percentage of power and a battery icon next to it on the top left of the page.

Clearing and Maintenance

Clearing and disinfecting

• For clearing and disinfecting the Smart Ring, the following procedures are recommended.
• Keep this device away from dust, lint, vibration, corrosive substances, explosive materials, high temperatures, and moisture.
• Clean and disinfect the device whenever you see any type of contamination.
• Clean and disinfect the device before giving it to a new user.
• Before cleaning and disinfecting, take away the Ring from the charging case.
• Clean the Ring and charging case once per week or more frequently if needed.
• The performance will be affected if there is any obstacle such as dust, lint, or stain on the sensor area, when necessary, clean the sensor area by following the directions in this manual.
• The surface of the Smart Ring can be gently wiped with an industrial nonabrasive cleaner or a soft cloth or sponge soaked in a solution with an alcohol content of 70%.
• The most commonly used hospital cleaning liquids and non-corrosive detergents can be used to clean the Smart Ring, but note that many of these cleaning agents must be diluted before use. Please follow the instructions of the cleaning agent manufacturer for use.
• Avoid using ethanol-based, amino-based, or acetone-based cleaning agents.
• The outer shell of the Smart Ring should be kept free from dust contamination and can be wiped with a lint-free soft cloth or a sponge soaked in a cleaning agent. Be careful not to pour liquid onto the instrument during cleaning, and ensure that no liquid enters the interior of the instrument. Be particularly careful when wiping to ensure that no water enters.
• It is prohibited to use abrasive materials such as wire brushes or metal polishing agents, as these materials may cause damage to the surface of the Ring.

Maintenance

• This device is a precision electronic device and necessary maintenance must be performed by Shenzhen Ninenove
• Technology Limited service ONLY, except charging the battery.
• No modification to this device is allowed, as it may affect the device’s performance.
• Do not break the surface of the smart ring, as it may damage the sensor, which may lead to malfunction and /or inaccurate measurement.
• Check the device and other parts at least once a week to ensure there is no visible damage that may affect the safety and performance of this device, when obvious damage is observed, stop using the device.
• Do not service or maintain any part of this device while it is being used with a patient.
• A functional tester cannot be used to assess the accuracy of this device.
• The ring can be charged by being placed onto the charging case.
• The device should be recharged every 3 months when it is not regularly used. If the battery is depleted, it may take longer charging time- 110 minutes before it returns to normal function.

Battery
To keep the battery in good condition, charge the battery every 6 months when the device is not in use. Please keep in remind to recycle the battery while the device reaches to life of use.

Troubleshooting

Specifications

FCC Caution

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,
2. this device must accept any interference received, including interference that may cause undesired operation.

FCC RF Radiation Exposure Statement

1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment.
3. The device has been evaluated to meet general RF exposure requirements. The device can be used in portable exposure conditions without restriction.

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.

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