4 Intended Use of the iSleep 20
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
The iSleep 20 has a pressure sensor that continuously monitors output pressure
to the patient and reference ambient pressure, so that the device automatically
will compensate for altitude changes.
The internal memory of the iSleep 20 can be downloaded to a PC where you
can view the patient compliance data in the Breas iSleep PC Software.
1.2 Indications for Use
The iSleep 20 is intended for non-invasive use.
The iSleep 20 shall only be used by patients with spontaneous breathing.
The CPAP function is intended to deliver continuous positive airway pressure
therapy for the treatment of obstructive sleep apnea in adults (who weigh more
than 30 kg).
The iSleep 20 can be used in clinical settings (e.g., hospitals, sleep laboratories,
sub-acute care institutions) and home environments. It must always be pre-
scribed by a licensed physician.
The iSleep 20 is intended to be operated by trained users and qualified person-
nel.
1.3 Contraindications
Therapy with the iSleep 20 should not be prescribed when the following spe-
cific diseases or conditions are present:
• Bullous lung disease
• Pathologically low blood pressure
• Severe cardiac arrhythmias
• Unstable angina pectoris
• Decompensated cardiac failure or hypotension, particularly if associated
with intravascular volume depletion
• Recent thoracic surgery
For more information about the Breas iSleep PC Software, please contact your
Breas representative.
The iSleep 20 is not intended for life support or life-sustaining
applications or for transport of critical care patients.
