3
This manual describes the operating methods, technical parameters and maintenance instructions
of the device. For future reference, keep this manual in a convenient, easily accessible place.
Warning:
Read this entire manual before using this device.
Caution:
In the US, federal law restricts this device to sale by or on the order of a physician.
Caution:
The components of the Somnera
™
System are not compatible with any other, non-
Somnera positive airway pressure devices.
INDICATIONS FOR USE
The Somnera
™
System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic
breathing pressure to a patient. It provides positive airway pressure during expiration and also
during an incipient apnea. The system includes a dedicated flow generator and a patient interface,
and is intended for use in the home environment. This system is to be used by adult patients
weighing more than 66 lbs (30 kg).
Contraindications
•
Severe bullous lung disease
•
A pneumothorax
•
Pathologically low blood pressure
•
Dehydration
•
Cerebrospinal fluid leak, recent cranial surgery or trauma
Warnings
•
This device should only be used with the Somnera
™
Airbox. The Somnera
™
System Mask,
Hose, Valve and Accessories are not compatible with any other respiratory systems or
accessories and use with other systems could reduce the effectiveness of the treatment,
result in improper operation or cause potential safety hazards.
•
Do not use this device in an MR environment.
•
Make sure you arrange the Hose so that it will not twist around your head or neck.
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