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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
aected 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.
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