Introduction
2
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.
• The effectiveness of ventilation and alarms should be verified including after any ventilation or
alarm setting change, any change in circuit configuration, or after a change to co-therapy (eg,
nebulisation, oxygen flow).
• The Astral device and AC Power Supply can get hot during operation. To prevent possible skin
damage do not leave the Astral device or AC Power Supply in direct contact with the patient for
extended periods of time.
• The device can provide therapies typically associated with both ventilator-dependent and
non-dependent patients. The mode of ventilation, circuit type, and alarm strategies should be
chosen after a clinical evaluation of each patient’s needs.
• The device must not be used at an altitude above 3000m or outside the temperature range of
32–104°F (0–40°C). Using the device outside these conditions can affect device performance
which can result in patient injury or death.
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