General Warnings And Precautions - ResMed Narval CC Professionell-Gebrauchsanweisung

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 appliance to the patient, the dental practionner shall check for
relevant issues in the patient's 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.
• It is necessary to perform a dental, periodontal, prosthetic and temporomandibular joint (TMJ)
examination. The following dental issues must be treated by a dental practitioner before MAD
treatment:
- Periodontal disease
- Cysts and mouth ulcers
- Teeth that need to be extracted
- Prosthodontics – such as crown or bridge
- Orthodontics
- Temporomandibular joint pain needs to be further assessed by patient's treating physician as well
as any other TMJ disorder.
• The dental practitioner shall check if the teeth (natural or dental implant) anchoring value and
retentive morphology are sufficient to ensure the efficacy of the MAD without significant side effect
of treatment.
• Regular dental review is recommended as well as a follow-up by a sleep specialist for OSA patient
to monitor treatment.
• The Narval CC appliance has been custom-made for a particular individual and is intended for use
only by that individual.
• For any product modification other than the ones described in these instructions for use,
please contact ResMed or one of its authorized dental lab partner.
• Patients treated with a Narval CC appliance must comply with the following instructions:
- Do not eat while wearing the Narval CC appliance.
- Only wear the Narval CC appliance when sleeping.
- Brush and rinse teeth before wearing the Narval CC appliance
- Patients must check their Narval CC appliance regularly. They must stop using it and contact
a dental practionner if they observe:
- any visible damage or cracking of a component,
- a connecting rod that detaches or must be replaced. In this case, the dental practionner will
provide a replacement connecting rod that is suitable for their treatment.
- Patients must contact you in case an elastic band needs to be replaced (if you ordered an appliance
with slots for elastic bands).
- They must not perform any product modification.
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