Contraindications; Adverse Effects; General Warnings And Cautions - ResMed Astral Serie Manual Del Usuario

Introduction

Contraindications

The Astral device is contraindicated in patients with the following pre-existing conditions:
• 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.
WARNING
AutoEPAP is contraindicated when using an invasive interface.

Adverse effects

Report unusual chest pain, severe headache or increased breathlessness to your physician. The following
side effects may arise during use of the device:
•
drying of the nose, mouth or throat • nosebleed
•
bloating
•
ear or sinus discomfort
• eye irritations
•
skin rashes.

General warnings and cautions

The following are general warnings and cautions. Further specific warnings, cautions and notes appear
next to the relevant instruction in the manual.
A warning alerts you to possible injury.
WARNING
•
If you notice any unexplained changes in the performance of the device, if it is making unusual
or harsh sounds, if the device or the power supply are dropped or mishandled discontinue use
and contact your healthcare provider.
• For ventilator-dependent patients, always have alternate ventilation equipment available, such
as a back-up ventilator, manual resuscitator or similar device. Failure to do so may result in
patient injury or death.
•
The Astral device is a restricted medical device intended for use by qualified, trained personnel
under the direction of a physician. Clinical supervision is required in critical care/intensive care
unit environments.
•
Ventilator-dependent patients should be continuously monitored by qualified personnel or
adequately trained carers. These personnel and carers must be capable of taking the necessary
corrective action in the event of a ventilator alarm or malfunction.
•
The Astral device is not intended to be operated by persons (including children) with reduced
physical, sensory or mental capabilities without adequate supervision by a person responsible
for the patient's safety.
• The Astral device is not intended to be operated by patients unless they have been given
adequate instruction concerning the operation of the device by a person responsible for the
patient's safety.
• The Astral device must not be used in the vicinity of an MRI device.
2