Safety; Intended Use - Sibelmed Somnibel Pro Manuel D'utilisateur

somnibel Pro
User's Manual

1. SAFETY

Somnibel Pro
is a new system for the treatment of patients with Sleep-Related Breathing Disorders (SRBD),
mainly the Sleep Apnea-Hypopnea Syndrome (SAHS) or habitual snoring during sleep. It has been developed by
the RDI Department of SIBEL S.A.U. with the collaboration of reference Health Centers and doctors specialized
in Sleep Disorders.
Somnibel Pro
has been designed for maximum safety. The complete operating instructions should be read before
proceeding to operate with the system. Failure to do so may result in injuries to the user or the patient and
damage to the device and/or accessories.

1.1 INTENDED USE

Somnibel Pro
The device is intended for the treatment of positional Sleep Apnea Hypopnea Syndrome (SAHS) or
positional snoring by applying a gentle vibrating stimulus when the patient sleeps in the supine position to induce
a change in the body position, thus reducing the incidence of sleep respiratory events; and for the monitoring,
efficacy evaluation, follow-up and adjustment of treatment settings of positional therapy by acquiring, visualizing
and analyzing the position, actigraphy and stimulus power signals.
The following conditions must be taken into account:
• Body-worn device
• Use into the health center, the patient's home or similar indoor use (not for outdoor use).
• Not intended for use in moving transport vehicles
EN 4
534-80P-MUM_Rev.1.08