1. Introduction
The ONIRIS Mandibular Advancement Orthosis is a self-adjustable dental device designed to address snoring and mild to moderate sleep apnea. It works by gently holding the lower jaw in a forward position during sleep, which helps to keep the airway open and reduce the vibrations of throat tissues that cause snoring.
This device has clinically proven efficacy, demonstrated through studies within the Assistance Publique, Hôpitaux de Paris hospital network. It is similar in concept to a night guard or sports mouthguard, but specifically engineered for airway management during sleep.
Image 1.1: ONIRIS product packaging, showing the orthosis, adjustment rods, and user manual.
Image 1.2: The "Fabriqué en France" logo, highlighting the product's origin.
2. Important Safety Information
Before using the ONIRIS orthosis, it is highly recommended to consult with a healthcare professional, such as a dentist or sleep specialist, to ensure this device is appropriate for your specific condition. While the ONIRIS orthosis is designed for safety and efficacy, improper use or pre-existing dental conditions could lead to discomfort or other issues.
- Do not use if you have severe gum disease, loose teeth, or significant dental pain.
- Consult your dentist if you experience persistent jaw pain, tooth sensitivity, or changes in your bite.
- The device is made from certified medical-grade materials (ISO13485, 0% BPA) and is registered with health authorities in France (Haute Autorité de Santé) and the USA (FDA).
- Keep out of reach of children.
3. Setup and Customization
The ONIRIS orthosis is designed for personalized fitting to ensure comfort and effectiveness. Follow these steps carefully for initial customization. The fitting process can be repeated if necessary.
3.1 Initial Fitting Steps
- Attach the Rods: Securely attach the provided adjustment rods to the upper rail of the orthosis.
- Heat the Orthosis: Place the ONIRIS orthosis in a bowl and cover it completely with boiling water. Ensure the water covers the rails for two minutes.
- Cooling Period: Carefully remove the orthosis from the hot water using a suitable utensil (e.g., tongs) and wait approximately 15 seconds for it to cool slightly. It should still be pliable but not too hot to handle.
- Position in Mouth: Stand in front of a mirror. Place the orthosis in your mouth, ensuring it is correctly oriented (upper part on top, lower part on bottom).
- Form Impression: Press your teeth firmly onto the rails of the orthosis. Important: Do not advance your jaw forward during this step. Simply bite down to create a clear impression of your teeth.
- Hold Position: Maintain this compressed position for 2 minutes, keeping your upper and lower jaws firmly pressed into the orthosis.
- Final Check: Remove the orthosis. You should see clear impressions of your teeth. If the fit is not satisfactory, you can repeat the heating and molding process.
Image 3.1: Visual guide for the ONIRIS orthosis fitting process.
Image 3.2: The ONIRIS orthosis, showing its design and components.
3.2 Adjustment for Mandibular Advancement
The ONIRIS orthosis allows for millimeter-precise adjustment of the lower jaw's forward position. This adjustment is achieved using different length rods (if provided, or by adjusting the existing mechanism) to find the optimal position that opens your airway without causing discomfort. Experiment with slight adjustments over several nights to find the most effective and comfortable setting.
The device is available in two sizes (Normal and Large) to accommodate different mouth anatomies.
4. Operating Instructions (Wearing the Orthosis)
Once customized, the ONIRIS orthosis can be easily inserted and removed. It is designed to be worn throughout the night to maintain an open airway.
4.1 How it Works
The orthosis gently advances your lower jaw, preventing the tongue and soft tissues at the back of your throat from collapsing and obstructing the airway. This allows air to flow more freely, eliminating the vibrations that cause snoring and improving breathing during sleep.
Image 4.1: Illustration of an open airway with the ONIRIS orthosis in use.
Image 4.2: Illustration of a constricted airway without the ONIRIS orthosis, demonstrating the cause of snoring.
4.2 Adaptation Period
It may take a few nights to become accustomed to wearing the orthosis. Initial discomfort, increased salivation, or a sensation of jaw stiffness upon waking are common. These symptoms typically subside as your mouth and jaw adapt to the device. If discomfort persists or worsens, re-evaluate the fit or consult a healthcare professional.
5. Care and Maintenance
Proper cleaning and maintenance are essential to ensure the longevity and hygiene of your ONIRIS orthosis.
- Daily Cleaning: After each use, clean the orthosis thoroughly with a toothbrush and toothpaste.
- Rinsing: Rinse the device with cold water after brushing.
- Deep Cleaning: Regular use of cleaning tablets (specifically designed for dental appliances) is recommended to prevent the buildup of odor and biofilm, which can extend the lifespan of your orthosis.
- Storage: Store the clean and dry orthosis in its protective case when not in use.
The ONIRIS orthosis typically has a lifespan of approximately 18 months. Its durability can be influenced by factors such as the acidity of your saliva, the quality of care, and the frequency of use.
6. Troubleshooting
| Issue | Possible Cause | Solution |
|---|---|---|
| Discomfort or pain in jaw/teeth | Incorrect fit, excessive jaw advancement, or initial adaptation period. |
|
| Orthosis feels loose or falls out | Improper impression during fitting. |
|
| Nausea or gagging sensation | Initial sensitivity to foreign object in mouth. |
|
| Snoring or sleep apnea not improving | Insufficient jaw advancement, or the condition may require a different treatment. |
|
Warning: If you experience severe or persistent dental issues, jaw pain, or believe the device is causing harm (e.g., tooth extrusion), discontinue use immediately and consult a qualified dental or medical professional. The ONIRIS orthosis is intended for specific conditions, and professional guidance is crucial for safe and effective use.
7. Product Specifications
- Brand: ONIRIS
- Model Name: ONIRIS
- Model Number: ONIRIS
- Product Dimensions: 15 x 8 x 5 cm
- Product Weight: 150 g
- Color: Transparent/Clear
- Age Range (Description): Adult
- Quantity: 1 unit
- GTIN (Global Trade Item Number): 03665389000019
- Certifications: ISO13485, BPA-free, FDA registered, registered with Haute Autorité de Santé (France).
- Manufacturer: ONIRIS
- First Available Date: February 7, 2023
8. Support and Contact Information
For any questions, advice, or support regarding your ONIRIS Mandibular Advancement Orthosis, please refer to the contact details provided in the physical user manual included with your product. You may also visit the official ONIRIS website for further information and assistance.
