Mechanism Of Action; Intended Use - ResMed Narval CC Manual De Instrucciones

ENGLISH
Introduction
Thank you for choosing the Narval CAD/CAM (computer-aided design
and manufacturing) appliance. This document provides user instructions
for Narval CC, Narval O.R.M and Narval Equinox
*
as your Narval appliance. Please read the entire manual before using
your device.

Mechanism of action

Your Narval 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
aid in opening 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.
Healthy patient Untreated
(airway open) snorer
(partially closed airway)
*Available only for France
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, referred collectively
*
Untreated Patient treated
OSA patient with Narval
appliance
(airway closed - apnoea)

Intended use

Narval CC
Narval CC is a custom-made medical device, available under medical
prescription and intended to treat snoring and/or obstructive sleep apnoea
(OSA) in adults. In the case of severe apnoea, Narval CC is recommended
as second-line intervention after continuous positive airway pressure
(CPAP) failure, non-compliance or refusal.
Narval O.R.M
*
Narval O.R.M is a custom-made medical device, available under medical
prescription and intended to treat OSA in adults. In the case of severe
apnoea, Narval O.R.M is recommended as a second-line intervention
after CPAP failure, non-compliance or refusal.
Narval Equinox
*
Narval Equinox is a custom-made medical device, available under medical
prescription and intended to treat snoring and / or OSA in adults. In the
case of severe apnoea, Narval Equinox is recommended as second-line
intervention after CPAP failure, non-compliance or refusal.
Contraindications
The Narval appliance is contraindicated for patients who:
• have central sleep apnoea;
• have severe respiratory disorders (other than OSA);
• have loose teeth or advanced periodontal disease;
• are under 18 years of age;
• have a completely edentulous arch;
• have a complete lower denture (not an overdenture);
• have short teeth and/or insufficient undercuts to retain the device.