Indications For Use - Sibelmed Somnibel Manual De Uso

1.2 INDICATIONS FOR USE

It is well known that more than 50% of SAHS patients experience a worsening in the frequency and severity of
respiratory events when sleeping in the supine position, compared to other body positions
dependency is more prevalent in mild to moderate, younger and less obese patients, which are the majority
of the total population of SAHS patients
(AHI) that is double in supine position compared to other positions
of snoring is also positional dependant in the majority of habitual snoring subjects
is avoided, the frequency of respiratory events is reduced in patients with positional Obstructive Sleep Apnea
(OSA) and positional therapy is considered an effective treatment for OSA in selected patients
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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 his/her position.
Somnibel
has been designed to be used by the patient at home and can be placed at the forehead or chest.
In both placements, the device vibration is able to induce a position change and, consequently, a reduction of
Somnibel
respiratory events.
and making it more comfortable and easy to use.
Somnibel
is indicated for patients older than 18 years, weighing over 40 kg and a height over of 145 cm. Although
not required, it is recommended to use the device under the supervision of a sleep physician for obtaining better
treatment results.
Somnibel
uses a rechargeable Lithium-polymer battery and includes USB connection for battery charge. It is
recommended to fully charge the battery before the first use of the device.
EN 5
. Positional SAHS is defined as an abnormal Apnea-Hyponea Index
5, 6, 7
includes several compliance enhancement features for favoring the patient's sleep
somnibel
1, 2, 3, 4
. Additionally, the severity and frequency
5, 7
. When the supine position
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User's Manual
. This positional
.
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534-800-MUM_Rev.1.06