Introduction; Indications For Use; Contraindications; Adverse Effects - ResMed Stellar 100 User Manual

Introduction

Read the entire manual before using the device. This User Guide is for a non-clinician user,
and does not contain all the information provided in the Clinical Guide.

Indications for use

The Stellar 100/150 is intended to provide ventilation for non-dependent, spontaneously
breathing adult and pediatric patients (30 lb/13 kg and above) with respiratory insufficiency,
or respiratory failure, with or without obstructive sleep apnea. The device is for noninvasive
use, or invasive use with an uncuffed or deflated tracheostomy.
Operation of the device includes both stationary, such as in hospital or home, or mobile,
such as wheelchair usage.
CAUTION
US Federal law restricts this device to sale by or on the order of a physician.

Contraindications

The Stellar is contraindicated in patients who are unable to endure more than brief
interruptions in ventilation. The Stellar is not a life support ventilator.
If you have any of the following conditions, tell your doctor before using this device:
• pneumothorax or pneumomediastinum
• pathologically low blood pressure, particularly if associated with intravascular volume
depletion
cerebrospinal fluid leak, recent cranial surgery or trauma
•
severe bullous lung disease
•
dehydration.
•
The use of the Stellar or pulse oximetry (including XPOD) is contraindicated in an MRI
environment.

Adverse effects

You should report unusual chest pain, severe headache or increased breathlessness to
your prescribing physician.
The following side effects may arise during the course of noninvasive ventilation with the
device:
• drying of the nose, mouth or throat
• nosebleed
bloating
•
ear or sinus discomfort
•
• eye irritation
• skin rashes.
Introduction 1