Welcome; Indications For Use; Contraindications; Adverse Effects - ResMed AirSense 11 Manual

Welcome

The AirSense 11 AutoSet™ (including AutoSet for Her) device is ResMed's premium auto-adjusting
pressure device. The AirSense 11 Elite and the AirSense 11 CPAP are ResMed's Continuous Positive
Airway Pressure (CPAP) devices.
WARNING
Read this entire guide before using the device.
CAUTION
In the US, Federal law restricts this device to sale by or on the order of a physician.

Indications for use

AirSense 11 AutoSet (including AutoSet for Her)
The AirSense 11 self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in
patients weighing more than 66 lb (30 kg), including female patients with mild to moderate OSA in AutoSet
for Her mode. The AirSense 11 self-adjusting system is intended for home and hospital use.
AirSense 11 CPAP (including Elite)
The AirSense 11 CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients
weighing more than 66 lb (30 kg). The AirSense 11 CPAP system is intended for home and hospital use.

Contraindications

Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing
conditions:
•
severe bullous lung disease
•
pneumothorax or pneumomediastinum
•
pathologically low blood pressure, particularly if associated with intravascular volume depletion
•
dehydration
•
cerebrospinal fluid leak, recent cranial surgery, or trauma.

Adverse effects

Patients should report unusual chest pain, severe headache, or increased breathlessness to their
prescribing physician. An acute upper respiratory tract infection may require temporary discontinuation of
treatment.
The following side effects may arise during the course of therapy with the device:
•
drying of the nose, mouth, or throat
•
nosebleed
•
bloating
• ear or sinus discomfort
•
eye irritation
•
skin rashes.
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