PROSOMNUS SLEEP TECHNOLOGIES ProSomnus RPMO2 Oximeter Device
Caution: Federal (U.S.) law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
Introduction
The ProSomnus® Remote Patient Monitoring (RPMO2) Oximeter Device contains a pulse oximeter sensor intended for measuring arterial blood oxygen saturation (SpO2) and pulse rate. ProSomnus RPMO2 Oximeter Devices are for single patient use, and are patient specific, simple to use, comfortable and easy to clean.
Indications
The ProSomnus RPMO2 Oximeter Device is an intraoral pulse oximeter indicated for use in measuring, displaying, storing, and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult patients. It is intended for continuous data collection. It can be used in sleep labs, long-term care, hospitals and home use. When used in combination with the ProSomnus Oxymetrx™ Patient App and ProSomnus Oxymetrx Provider Portal, the device allows for remote collection of patient’s physiological data.
Intended Use
The device is intended for:
- Patient-specific use
- Patients who are over 18 years of age
- Continuous data collection
- Use inside the oral cavity
- Use in non-motion conditions
- Use in well perfused area
- Use at home, sleep labs, long-term care, and hospitals
- Patient is an intended operator
Contraindications
The device is contraindicated for patients who:
- Have loose teeth or advance periodontal disease
- Are under 18 years of age
Warnings
Use of the device may cause:
- Tooth movement
- Gingival or dental soreness
- Obstruction of oral breathing
- Excessive salivation
- Does not provide physiological alarms during use
- Do not expose the sensor and accessories to temperatures over 131° Fahrenheit (55° Celsius) as this may damage the sensor
- Do not eat, swallow, drop, hit, abuse, open, incinerate, burn or short-circuit the sensor, its accessories, or its components
- Discontinue use and contact your prescriber if the device appears damaged
- Discontinue use if an allergic reaction occurs
- The maintenance of this product is limited to qualified maintenance personnel designated by the manufacturer. Users should not repair this device by themselves and are not allowed to modify this device
- Do not perform maintenance and upkeep during use
- The product cannot be used while charging
- Possible strangulation by the charging station cable
- This product is not suitable for use with products other than those specified in this manual
- This device is calibrated to measure blood oxygen saturation
- Functional testers cannot be used to evaluate the SpO2 accuracy of ProSomnus RPMO2 oximeters
- Data averaging and signal processing cause delays in the transmission of SpO2 data values, and the measurement data update cycle is less than 30 seconds.
- The recommended maximum usage time for the device is 10 hours daily
- Interference from electrosurgical equipment can affect measurement accuracy
- Device poses a significant risk of interference during certain investigations or treatments such as magnetic resonance imaging (MRI) and computed tomography (CT) scans
- When using this product, avoid proximity to equipment generating strong electric and magnetic fields. Inappropriate usage environments may cause interference with nearby radio devices or impact the product’s operation
- Do not place the device in direct sunlight, high temperature, humidity, cotton wool, and dusty areas to avoid affecting the performance of the device
- Excessive ambient light, frequent movement (active or passive) or vigorous activity of the user can affect measurement accuracy
- Expected time for transition from storage temperature extremes to room temperature is 4 hours
- Do not dispose the device with other domestic waste; instead, bring it to a recycling center for electric and electronic equipment
- Do not eat or drink while using the device
- Do not short-circuit the battery
- Do not dispose in fire
- The battery needs to be recharged every 3 months when not in use
- Connecting to the Bluetooth network, including other devices may bring unknown risks. If there are any related risks or questions, please contact ProSomnus Sleep Technologies for assistance to solve the related issues
Do’s
- Read the user manual before use
- Follow the instructions in the ProSomnus Oxymetrex Patient App before use
- Battery service life is one year. Return to the prescriber at least one month before the one-year mark, or when needed, for re-evaluation.
- Fully charge the oximeter before use
Troubleshooting
The device does not charge:
- Ensure the ProSomnus RMPO2 Oximeter Device is centered on the ProSomnus RMPO2 Charging Station. Slightly adjust the device’s position on the stand until the LED indicator on the charger turns on.
Device is not discoverable:
- Place the ProSomnus RMPO2 Oximeter Device on the charger.
- Ensure the device is within 10 feet of the mobile phone.
- Disable devices or applications that may have connected with the device in the past.
- Attempt to discover the device with the ProSomnus Oximetry Patient App.
Graphical Plot of All Sampled Data Points
In human experiments, the accuracy of SpO2 is verified by comparing measurements from arterial blood samples with those from a CO-Oximeter.
Pulse rate accuracy is verified in human experiments and using a simulator.
Each ProSomnus RPMO2 Oximeter Device Package Contains:
- 1 maxillary arch with sensor
- 1 ProSomnus RPMO2 Charging Station
- User Manual
- Storage case(s)
Material Content:
- Medical grade polymer
- Medical grade adhesive
- Fully embedded Printed Circuit Board Assembly (PCBA)
The ProSomnus RMPO2 Oximeter Device sensor captures and stores the patient’s physiological data. The ProSomnus Oxymetrx Patient App and ProSomnus Oxymetrx Provider Portal are required to view and analyze this data. The data collected and stored in the ProSomnus RPMO₂ Oximeter Device is transferred to the ProSomnus Oxymetrix Provider Portal via the ProSomnus Oxymetrix Patient App. The prescribing physician can view and create reports to analyze patient data and results from the ProSomnus Oxymetrx Provider Portal. Patients can view their sleep score, device usage, SpO2, pulse rate, and Oxygen Desaturation Index (ODI) using the ProSomnus Oxymetrx Patient App.
Directions for Daily Use of the ProSomnus RPMO2 Oximeter Device
- For physiological data collection, ensure the ProSomnus RMPO2 Oximeter Device sensor is fully charged and registered with the ProSomnus Oxymetrx Patient App.
- Insert prior to sleep.
- Inspect the device prior to use. Contact your prescriber if you observe any abnormalities.
- Rinse with water before use.
- Open your mouth wide, and secure the device onto your teeth.
- Gently relax your jaw and settle down for a restful night.
- To remove the device:
- a. Gently open your mouth and apply downward pressure on the front of the device with your index fingers.
- b. Open the ProSomnus Oxymetrx Patient App, connect with the oximeter device to upload physiological data to ProSomnus Oxymetrx Provider Portal.
- c. Charge the ProSomnus RMPO2 Oximeter Device by placing it on the ProSomnus RPMO2 Charging Station, ensuring both device and station LEDs indicate charging is in progress as shown in Figure 1.
Note: Do not remove one-handed, this will place unnecessary torque on the arch frame and can cause breakage
Light Indication
| Operation Mode | Sensor | Charger |
| Charging | Green light flashing | Green light flashing |
| Charging complete | Green light on for 15s | Green light solid on |
| Connect to ProSomnus Oxymetrx Patient App | Green light flashes twice | N/A |
| Device Firmware Upgrade | Green light always on | N/A |
| Fault | Red light flashing | Red light flashing |
Cleaning Instructions for the ProSomnus RPMO2 Oximeter Device
Note: Sterilization, calibration and maintenance are not required.
Daily:
- After use, thoroughly clean your ProSomnus RPMO2 Oximeter Device using a regular soft toothbrush, cool or warm water and mild detergent, such as orthodontic device cleansers or antibacterial liquid soaps.
- Avoid scuffing or damaging the surface location near the LED.
- Rinse thoroughly. Place on the ProSomnus RPMO2 Charging Station to ensure adequate charge. When traveling, store in the travel container.
- Daily soaking of your device is not recommended.
Note: Mouthwash, bleach solutions, denture cleaners or abrasive toothpaste may harm the device.
Storage
Keep the ProSomnus RPMO2 Oximeter Device and its accessories away from small children and pets. The ProSomnus RPMO₂ Oximeter Device should be stored in a cool, dry place. Ensure the device is not exposed to extreme temperatures in excess of 55°C/131°F.
Biological Hazards and Waste Disposal
Biological Hazards:
The ProSomnus RPMO₂ Oximeter Device may be exposed to harmful bacteria, viruses, fungi (molds, yeasts), and parasites, including COVID-19.
Waste Disposal Instructions:
For Patient-Users:
- Contact local authorities for guidance on disposing of potentially biohazardous parts and accessories.
- Follow healthcare provider or local health department instructions for biohazardous waste disposal.
For Organizations:
- Consult with local authorities to determine proper disposal methods for biohazardous materials.
- Ensure personnel handling biohazardous waste are trained and equipped with protective gear.
COVID-19 Considerations:
- Take additional precautions when handling parts exposed to COVID-19.
- Adhere to guidelines from health authorities regarding COVID-19 .. waste management.
Essential Performance
| PULSE RATE (PR) ACCURACY | |
| PR Measurement Range | 45 -220 bpm |
| ARMS | 1.86 bpm |
The pulse rate accuracy was tested by a pulse rate functional tester per the recommendation of ISO 80601-2-61.
| FUNCTIONAL OXYGEN SATURATION (SpO₂) ACCURACY | |
| SpO₂ Measurement Range | 70-100% (Resolution: 1%) Below 70% no definition |
| ARMS | 2.94% |
*ARMS accuracy is a statistical calculation of the difference between device measurement and reference measurements. The sensors’ accuracy was assessed against co-oximeter samples across the SpO2 range of 70% to 100%. This accuracy data was determined using the root-mean-square ARMS value for all subjects, in accordance with ISO 80601-2-61: Medical Electrical Equipment— Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
FCC Statement
FCC Warning
ProSomnus RPMO2 Oximeter Device
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.
Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the device.
Note: This device 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 device generates 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 device does cause harmful interference to radio or television reception, which can be determined by turning the device 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 device and receiver.
- Connect the device 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 radio frequency (RF) exposure requirements. The device can be used in portable exposure condition without restriction.
ProSomnus RPMO2 Charging Station
Note: This device complies with part 18 of the FCC Rules.
Information to the user.
- The device has potential interference, but the interference is very small and meets the requirements of the FCC rule.
- Device system maintenance is simple, please refer to the manual.
- The user can take simple measures to correct the interference.
Such as staying away from interference sources, turning off interference sources, etc.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20cm between the radiator & your body.
Technical Specifications
| FCC ID | 2BKS2-RPMO2OXIMETER
2BKS2-RPMO2CHARGER |
| SN | See the outer package for details |
| Date of Manufacture | See the outer package for details |
| Bluetooth Version | 4.1 and above |
| Bluetooth Effective Range | Within 10 meters |
| Battery Capacity | 24 mAh |
| Battery Life | Recording continuously for 8 hrs |
| Charging Input | USB-A 5V 1A |
| Waterproof Grade | IP68 for ProSomnus RPMO2 Oximeter Device
IP22 for ProSomnus RPMO2 Charging Station |
| Green light | Wavelength about 525nm, maximum optical output power 4.5 mW |
| Red light | Wavelength about 660nm, maximum optical output power 7.3 mW |
| Infrared light | Wavelength about 940nm, maximum optical output power 5.3 mW |
| Operating Condition | 5°- 40°C (41°- 104°F). Do not operate when the pressure is below 740 mbar. |
| Storage and Transportation Conditions | -25°- 55°C (-13°- 131°F).
Relative humidity ≤85%. No corrosive gas. Good ventilation. Air pressure not less than 740mbar for indoor storage and transportation. |
ProSomnus Oxymetrx Patient App
Consult instructions for use: prosomnus.com/instructions
ProSomnus® is a Registered Trademark. ProSomnus, the “O” logo design, artwork, and designs contained herein are trademarks and copyrights of ProSomnus Sleep Technologies, Inc. and may not be reproduced, distributed, displayed, published, altered or used without prior written consent.
- prosomnus.com/patents
- PRO3-431-Draft (October 2024)
- ProSomnus Sleep Technologies
- 5675 Gibraltar Drive
- Pleasanton, CA 94588, USA
- Main +1 844 537 5337
- ProSomnus.com
FAQ
- Q: How often should I charge the ProSomnus RPMO2 Oximeter Device?
- A: It is recommended to charge the device daily to ensure continuous functionality.
- Q: Can I use any toothpaste to clean the device?
- A: Avoid using abrasive toothpaste to clean the device as it may damage its components.
Documents / Resources
 |
PROSOMNUS SLEEP TECHNOLOGIES ProSomnus RPMO2 Oximeter Device [pdf] User Manual 2BKS2-RPMO2CHARGER, 2BKS2RPMO2CHARGER, ProSomnus RPMO2 Oximeter Device, ProSomnus RPMO2, Oximeter Device, Device |