Device Dossier
Patient positioning sensor
Device Dossier for Patient positioning sensor (Patient positioning sensor, Class IIa, sponsor Bird Healthcare). ARTG record, intended purpose, GMDN…
- GMDN category: Patient positioning sensor
Intended purpose
Somnibel is a body-worn, active device able to detect the position of the patient during sleep and to generate a gentle vibration, depending on the detected position, that induces the patient to change body position. The Somnibel Pro is a body-worn, active device intended to be used by medical staff for the treatment of positional Sleep Apnea Hypopnea Syndrome (SAHS) or positional snoring by applying gentle vibration to induce a change in the body position, to reduce the incidence of sleep respiratory events and to record the body position, actigraphy and stimulus power signals for subsequent analysis.