Introduction
English 3
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 internal battery is not intended to serve as a primary power source. It should only be used
when other sources are not available or briefly when necessary; for example, when changing
power sources.
• 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 or diathermy 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
0–40°C. Using the device outside these conditions can affect device performance which can
result in patient injury or death.
• The device should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
• The use of accessories other than those specified for the device is not recommended. They
may result in increased emissions or decreased immunity of the device.
• Additional equipment connected to medical electrical equipment must comply with the
respective IEC or ISO standards. Furthermore, all configurations shall comply with the
requirements for medical electrical systems (see IEC 60601-1). Anybody connecting additional
equipment to medical electrical equipment configures a medical system and is therefore
responsible that the system complies with the requirements for medical electrical systems.
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