Ninenovo OSRMB-01 Sleep System: A Comprehensive Guide

The Ninenovo OSRMB-01 Sleep System is a wearable medical device designed to monitor and analyze sleep-related parameters, aiding in the evaluation of sleep disorders such as sleep apnea. This system is intended for use in both clinical and home settings under the guidance of healthcare professionals. Ninenovo OSRMB01 manual

Overview

The OSRMB-01 Sleep System comprises a smart ring and a charging case, along with a companion mobile application. The primary function of the system is to record, analyze, display, export, and store biophysical parameters to assist in evaluating moderate to severe sleep-related breathing disorders in adult patients suspected of sleep apnea.

Key Features

• Biophysical Monitoring: The system monitors parameters such as blood oxygen saturation (SpO₂) and pulse rate (PR) during sleep.

• Wireless Connectivity: Utilizes Bluetooth 5.2 BLE to sync data with the Ninenovo Health mobile application.

• Mobile Application: Available on iOS and Android platforms, the app facilitates data visualization, monitoring, and report generation.

• Rechargeable Battery: Both the smart ring and charging case are equipped with rechargeable lithium batteries.

• Water Resistance: The smart ring has an IP68 rating, indicating resistance to dust and water immersion.

Intended Use

The Ninenovo Sleep System is intended to:

• Record and analyze sleep-related parameters.

• Aid in the evaluation of sleep disorders like sleep apnea.

• Be used in clinical and home settings under the direction of a healthcare professional.

Note: The data provided by this device is for pre-check screening purposes only and cannot be directly used for diagnosis or treatment.

Components

The OSRMB-01 Sleep System includes:

• Smart Ring: Worn on the finger to monitor sleep parameters.

• Charging Case: Used to charge the smart ring.

• Charging Cable: For connecting the charging case to a power source.

• User Manual: Provides instructions for setup and usage.

Setup and Usage

1. Charging the Smart Ring

Before the first use, charge the smart ring for approximately 60 minutes or until the battery level exceeds 80%. Place the ring in the charging case, ensuring proper alignment with the charging contacts.

2. Installing the Mobile Application

Download the "Ninenovo Health" app from the App Store (iOS) or Google Play Store (Android). Install the app and register an account to begin using the system.

3. Pairing the Smart Ring with the App

Open the Ninenovo Health app, navigate to the "Me" page, and select "Bind the device." Ensure Bluetooth is enabled on your mobile device and keep the smart ring within one meter of the phone during the pairing process.

4. Wearing the Smart Ring

Wear the smart ring on the base of your finger, ensuring the sensors are positioned correctly. The ring should fit snugly but comfortably to obtain accurate readings.

5. Monitoring Sleep Parameters

Before sleep, open the app, navigate to the "Research" page, and select "Start Monitoring." Ensure the app remains open during sleep to continuously monitor and record data. Upon waking, swipe to stop monitoring and generate a report.

Maintenance and Care

Cleaning

• Smart Ring: Clean the ring weekly or more frequently if necessary. Use a soft cloth or sponge soaked in a solution with 70% alcohol. Avoid using ethanol-based, amino-based, or acetone-based cleaning agents.

• Charging Case: Wipe the charging case with a soft, lint-free cloth. Do not pour liquid directly onto the device.

Battery Maintenance

To maintain battery health, charge the smart ring every 3 months when not in regular use. If the battery is completely depleted, it may require a longer initial charging period.

Storage

Store the device in a cool, dry place away from direct sunlight, high temperatures, and moisture. Avoid exposure to corrosive substances and electromagnetic interference.

Troubleshooting

Specifications

• SpO₂ Range: 70% to 100%

  • Accuracy:

    • 90%-100%: ±2%

    • 80%-89%: ±2%

    • 70%-79%: ±3%

• Pulse Rate Range: 30 bpm to 240 bpm

  • Accuracy: ±2 bpm or ±2%, whichever is greater

• Wavelength:

  • Red Light: 640nm ±20nm

  • Infrared Light: 940nm ±20nm

• Weight: 3g - 5g

• Operating Environment: 5°C to 40°C

• Storage Conditions:

  • Temperature: -20°C to 60°C

  • Humidity: 10% to 95% RH

• Mobile App Compatibility:

  • iOS: Version 14.0 or above

  • Android: Version 8.0 or above

• Wireless Connectivity: Bluetooth 5.2 BLE

• Water Resistance:

  • Smart Ring: IP68

  • Charging Case: IP22

Safety and Compliance

The Ninenovo Sleep System complies with international standards:

• IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

• IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests.

• IEC 60601-1-11: Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

• ISO 80601-2-61: Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

• ANSI C63.27: American National Standard for Testing and Measurement Techniques – Testing and Measurement Techniques – Medical Devices – Electromagnetic Compatibility.

Conclusion

The Ninenovo OSRMB-01 Sleep System offers a comprehensive solution for monitoring sleep-related parameters, aiding in the evaluation of sleep disorders like sleep apnea. Its user-friendly design, combined with advanced features and compliance with international standards, makes it a valuable tool for both healthcare professionals and patients.