General Warnings And Precautions - ResMed Narval CC Instructions For Use Manual

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.
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.
4 ENGLISH
• 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.