General Information; Indications Of Use; Intended Use - NOMICS BRIZZY NS21 Manuel D'utilisation

Eng

GENERAL INFORMATION

INDICATIONS OF USE

BRIZZY is indicated for use in the screening and diagnostic evaluation of sleep breathing
disorders in pediatric and adult patients.
BRIZZY produces a report for the HCP that may aid in the diagnosis of sleep breathing disorders
or for further clinical investigation.

INTENDED USE

BRIZZY is a portable sleep recorder made for detecting sleep apnea syndrome and for monitor-
ing its treatment.
It is intended for use by health professionals having basic knowledge of sleep disorders, in
particular of sleep breathing disorders.
BRIZZY can be used at home and sleep clinics, and is for patients over three years of age.
BRIZZY (NS121 model) records the following parameters:
1. Mandibular movement: mandibular activity presents characteristics which permit the detec-
tion of respiratory events during sleep.
2. Body position: indication of the patient's sleeping position.
CERES – the software – allows the patient data to be sent to a secure and anonymized site,
and to receive the analyzed data in the form of an analysis report. This report then helps the
operator determine:
• if the patient suffers from sleep breathing disorders,
• whether the treatment given to a patient with such disorders should be adjusted.
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