General Warnings And Cautions - ResMed Stellar Series User Manual

General warnings and cautions

WARNING
A warning alerts you to possible injury.
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Read this entire guide before using the device.
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This device should only be used with air tubing and accessories recommended by ResMed or the
prescribing clinician. Use of incorrect air tubing and accessories may affect the functioning of this
device.
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The device and the accessories are to be used for the specified intended use only.
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The device must only be used with masks (and connectors
clinician or respiratory therapist. A mask should not be used unless the device is turned on and
operating properly. The vent hole or holes associated with the mask should never be blocked.
Explanation: The Stellar is intended to be used with special masks (or connectors
vent holes to allow continuous flow of air out of the mask. When the device is turned on and
functioning properly, new air from the device flushes the exhaled air out through the mask vent
holes. However, when the device is not operating, insufficient fresh air will be provided through
the mask, and the exhaled air may be rebreathed. Rebreathing of exhaled air for longer than
several minutes can, in some circumstances, lead to suffocation. This applies to most Positive
Airway Pressure devices.
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In the event of power failure
from the tracheostomy tube.
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Explosion hazard—do not use in the vicinity of flammable anesthetics.
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Do not use the device if there are obvious external defects, unexplained changes in performance.
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Only use original and approved ResMed accessories and parts.
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Use only accessories from the original package. If the packaging is damaged, the respective
product must not be used, and should be disposed along with the packaging.
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Before using the device and the accessories for the first time, ensure that all components are in a
proper condition and that their operational safety is guaranteed. If there are any defects, the
system should not be used.
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Additional equipment connected to medical electrical equipment must comply with the
respective IEC or ISO standards (eg, IEC 60950 for data processing equipment). Furthermore all
configurations shall comply with the requirements for medical electrical systems (IEC 60601-1-1).
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. Attention is drawn to the fact that local laws take priority over the above
mentioned requirements. If in doubt, consult your local representative or the technical service
department.
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No modification of this equipment is allowed.
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Single-use products are not to be re-used due to degradation and contamination risks.
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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.
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The use of accessories (eg, humidifiers) other than those specified for the device is not
recommended. They may result in increased emissions or decreased immunity of the device.
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Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm to any part of the device, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
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The device performance may be affected when used above recommended altitude or outside of
recommended outside temperature range.
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User must not connect the Stellar device to the battery of a battery-powered wheelchair as this
can affect the device performance and may result in patient harm.
2
or machine malfunction, remove the mask or the catheter mount
1 ) recommended by ResMed, or by a
1 ) which have
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