ResMed Narval CAD/CAM
Overview
Introduction
Thank you for choosing the Narval CAD/CAM (computer aided design and computer aided manufacturing) oral appliance. This document provides instructions for patients using the Narval CC™ appliance. Please read the entire instructions for use before using your device and, if you have any questions, contact your dental practitioner.
Mechanism of action
Your Narval CC appliance maintains the lower jaw (mandible) in a forward position, which in turn draws the base of the tongue forward and widens the airways in the pharyngeal area behind the tongue.It is designed to help open up the space behind the tongue and increase the tension of relaxed soft tissues to help reduce snoring and decrease the number of apnoeas and hypopnoeas that may disturb the physiological sleep cycle.
Indications
The Narval CC appliance is a custom-made mandibular advancement device (MAD), available under medical prescription, and intended to treat adults with:
- Mild to moderate obstructive sleep apnoea (OSA)
- Severe obstructive sleep apnoea in the case of continuous positive airway pressure (CPAP) failure, non-compliance or refusal (second-line treatment)
- Snoring.
Contraindications
The Narval CC appliance is contraindicated for patients who:General contraindications
- Have central sleep apnoea
- Have severe respiratory disorders (other than OSA)
- Are under 18 years of age
Dental contraindications
- Have loose teeth or advanced periodontal disease
- Have a completely edentulous lower arch unless a complete denture mechanically retained is present (e.g. retained by implants)
- Have a completely edentulous upper arch unless a complete upper denture is present
- Have short teeth and/or insufficient undercuts to retain the device.
General warnings and precautions
Information related to warnings and precautions in the instructions for use explains special measures to be taken for the safe and effective use of the Narval CC appliance, including information on potential side effects.Any serious incident that occurs in relation to this device should be reported to ResMed and to the competent authority in your country.
PRECAUTION
- Prior to prescribing the Narval CC appliance, the dental practitioner shall:
- Check for relevant issues in your medical history, such as respiratory disorders, asthma and breathing problems, allergies. Patients with any such problems should be referred to a qualified health professional before treatment.
- Perform an examination to ensure that your dental condition is suitable for treatment with a MAD.
- • Your Narval CC appliance has been custom-made according to your morphology.It is intended for your personal use only.
- Check your Narval CC appliance on a regular basis. If there is any visible damage or cracking of a component, discontinue use and consult your dental practitioner.
- Product adjustments can only be performed by a dental practionner.
- The Narval CC appliance works with two connecting rods. If a connecting rod detaches or must be replaced, stop using your Narval CC appliance and contact your dental practitioner, who will provide a replacement connecting rod that is suitable for your treatment.
- Your dental practitioner may have ordered a Narval CC appliance with two slots intended to allow the addition of orthodontic elastic bands. Contact your dental practitioner if an elastic band needs to be replaced.
Daily use
- Do not eat while wearing your Narval CC appliance.
- Only wear your Narval CC appliance during sleep.
- Brush and rinse your teeth before wearing your Narval CC appliance.
Treatment follow-up
- Regular dental review is recommended.
- If your Narval CC appliance has been prescribed to treat OSA, follow-up with your sleep specialist is also recommended to monitor the treatment.
WARNING
- Using the Narval CC appliance may cause the following expected side effects:
- Temporomandibular joint disorders
- Discomfort (e.g. mouth dryness, hyper salivation, nausea)
- Occlusion change
- Mouth pain, irritation or injury (e.g. gingivitis, mouth ulcer)
- Dental pain
- Tooth migration or dental mobility
- Dental fracture or prosthesis loosening
- Allergy.
- In extremely rare cases, an obstruction of oral breathing may occur.
If you experience any serious or persistent side effect or aggravation of an existing dental condition, discontinue use of your Narval CC appliance and contact your dental practitioner or a qualified health professional.
- You may experience some tooth pain when using your Narval CC appliance. This is most likely to occur upon waking up. The pain usually disappears as you get used to the treatment. If pain persists, consult your dental practitioner.
- If you wear fixed prosthetics (crown, bridge, veneer, etc.) they may detach on very rare occasions or your upper removable denture may need to be adjusted. If this occurs, please ask your dental practitioner to adjust the prosthetics or denture and adapt your Narval CC appliance to reduce the risk of further detachment.
Contents of the packaging
The Narval CC appliance is shown on page 2 of this leaflet. It is made of polyamide and comprises the following components:
- Lower splint
- Upper splint
- Connecting rodsThe Narval CC appliance is delivered with the following items:
- A storage box
- Connecting rod kit(s) to allow the dental practitioner to adjust the mandibular advancement – not shown
- Instructions for use (one for patients and one for professionals) – not shown
To insert your Narval CC appliance
PRECAUTION: The first fitting in mouth must be supervised by your dental practitioner.
You may find it easier to look in a mirror the first few times you position your Narval CC appliance. 
- Rinse your Narval CC appliance with water.
- Position it in your mouth with the upper splint (the narrower one) against your upper teeth.
- Press firmly on the splint with your fingers until it fits into place. Do not pull or press on the connecting rods to adjust the position. You may hear a ‘snap’ as the Narval CC appliance fits into place.
- Bring the lower jaw forward and follow the same process to slide in the lower splint.
Do not bite down on the splint to insert it on to your teeth. If you find it difficult to insert your Narval CC appliance, try inserting the lower splint first.
To remove your Narval CC appliance
- Place your fingers on each side of the lower splint and apply gentle, even pressure to lift it.
- Proceed in a similar way with the upper splint.
- Remove the Narval CC appliance from your mouth.
- Clean it according to the instructions in the Cleaning section.
Cleaning
PRECAUTION
- Before choosing an antibacterial denture cleanser, you should verify that you are not allergic to any of its ingredients. Always follow the instructions provided with it.
- Do not put your Narval CC appliance in water that is warmer than 45 °C/113 °F.
- Do not use toothpaste, mouthwash or soap to clean your Narval CC appliance.
- Do not use chlorine-based products, bleach, acetic acid, household cleaning products or alcoholic solutions to clean your Narval CC appliance.
After every use of your Narval CC appliance:
- Remove it from your mouth and immerse it in lukewarm drinking-quality water in a clean glass or container.
- Brush it all over for at least 1 minute, paying particular attention to the inner surface. Use a denture brush or a toothbrush that you only use for cleaning your Narval CC appliance. Replace the brush when the bristles fray.
- Rinse well with clean, lukewarm drinking-quality water
- Carefully inspect your Narval CC appliance to confirm it is visibly clean (e.g. no visible particles remaining on the appliance).If necessary, clean the appliance again, repeating steps 2 through 4.
- Once clean, dry it with a clean towel and place it back in its storage box.
Twice a week, clean your Narval CC appliance more thoroughly, using an antibacterial denture cleanser intended for orthodontic appliances:
- Read the instructions on the antibacterial denture cleanser carefully before use.
- Clean your Narval CC appliance following the instructions provided by the cleanser manufacturer.
- Rinse it well with clean, drinking-quality water.
- Dry it with a clean towel and place it back in its storage box.
Over time, the splints of your Narval CC appliance might change colour. This may be due to the acidity of your saliva, coloured drinks or how well you take care of your Narval CC appliance. This will not affect its performance.
Storage and disposal
- Ensure that your Narval CC appliance is clean and dry before you store it.
- To protect your Narval CC appliance, store it in its storage box at room temperature in a dry place away from direct sunlight.
- The Narval CC appliance and items do not present specific hazards and can be disposed of with your normal household refuse.
Symbols
Warranty
ResMed acknowledges all consumer rights granted under the EU Directive 1999/77/EC and respective national laws within the EU for products sold within the European Union.
The warranty below is a voluntary manufacturer’s warranty offered by ResMed SAS (“ResMed”). It is in addition and without prejudice to your mandatory rights under applicable law.
- ResMed guarantees all Narval CC appliances supplied to be free from defects in materials and workmanship for a period of 2 years from the manufacturing date shown in the packaging.In specific circumstances, which may vary from region to region, your warranty period may be longer than 2 years. For details, please contact your dental practitioner. During the warranty period and at its complete discretion, ResMed will adjust or replace any Narval CC appliance that is covered by the warranty.
- Adjustments covered by the warranty may only be performed by a ResMed facility or a ResMed authorised partner.
- The warranty does not cover:
- damage that is not caused by manufacturing defects,
- devices that do not fit due to defective or distorted impressions and/or defective or distorted bite registrations,
- dental calculus deposits, stains, changes of colour or odours,
- damage caused by a pet.
- The warranty shall be void if:
- the patient had dental restorative work or dental modifications (e.g. tooth extractions, new crowns, new dental prosthetics) during the warranty period and the defect results from the work or modification,
- the Narval CC appliance was not used and cleaned in accordance with the instructions for use, or
- the Narval CC appliance was modified by a non-authorised party.
- For the warranty to be honoured, the following elements must be returned to ResMed by the dental practitioner: both splints with their connecting rods, storage box and the patient’s dental models.
Note for blind or visually impaired usersAn electronic version of these instructions for use is available online on the product information pages on ResMed.com
References
[xyz-ips snippet=”download-snippet”]