Indications For Use; Contraindications - Breas iSleep 20+ User Manual

The iSleep 20+ has a memory that stores the usage, and can be downloaded by
your care provider to a PC.

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.
The iSleep 20+ is not intended for life support or life-sustaining applica-
tions or for transport of critical care patients.

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
• Coronary artery disease
• Unstable angina pectoris
• Decompensated cardiac failure or hypotension, particularly if associated
with intravascular volume depletion
• Recent thoracic surgery
• Pneumothorax
• Pneumomediastinum
• Massive epistaxis or previous history of massive epistaxis
(risk of recurrence)
4 Intended Use of the iSleep 20+
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b