Safety; Intended Use - Sibelmed SOMNIBEL Manuel De L'utilisateur

somnibel
User's Manual

1. SAFETY

Somnibel
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
has been designed for maximum safety. The complete instructions for use should be read before
proceeding with the device use. Failure to do so may result in injuries to the user and damage to the device
and/or accessories.

1.1 INTENDED USE

Somnibel
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.
The following conditions must be taken into account:
• Body-worn device
• Use into the patient's home or similar indoor use (not for outdoor use).
• Not intended for use in moving transport vehicles
EN 4
534-800-MUM_Rev.1.05