4
Intended Use
Intended use
NightBalance is intended as a therapy for mild to moderate Positional Obstructive Sleep
Apnea (POSA) in adults with a non-supine AHI<10. NightBalance is intended to be used
by patients during sleep in their home environment. The device is to be used only on the
instruction of a licensed physician.
Indications for use
The following are the Indications for Use for NightBalance.
•
You are at least 18 years of age.
•
You have a supine AHI which is at least twice as high as the non-supine AHI.
•
You have been diagnosed with mild or moderate OSAS (5
≤
AHI
≤
30).
•
You have an AHI in non-supine position below 10.
•
You sleep at between 10-90% in supine position.
•
You should be able to switch sleeping positions independently.
Contraindications for use
•
NightBalance should not be used by a patient using another medical aid that can be
affected by mild vibrational stimuli - on the chest.
•
NightBalance is not recommended for the treatment of patients who are supposed to
sleep in a supine position because of a medical condition (e.g. because of shoulder of
back surgery or osteoarthritis).
•
NightBalance cannot be used by patients who sleep in an upright position or require
more than 2 pillows during sleep.
Intended Use
