ResMed 248551/1 Introduction, Indications for use, Contraindications, Adverse effects, English

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 is intended to provide ventilation for non-dependent, spontaneously breathing adult and paediatric patients (13 kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnoea. The device is for noninvasive use, or invasive use with an uncuffed or deflated tracheostomy.

Users of the device include patients and their caregivers, physicians, nurses, respiratory therapists and other clinical staff. Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

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.

English

Introduction 1