ResMed Stellar Serie Guia Del Usuario página 36

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).
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.
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Under normal or single fault conditions the entire pneumatic flow path can become
contaminated with body fluids or expired gases, if bacterial/viral filters are not installed on the
ventilator outlet.
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The device has not been tested or certified for use in the vicinity of X-ray, CT or MRI equipment.
The device must not be used in the vicinity of an MRI device. Never bring the device into an MR
environment.
1
Ports may be incorporated into the mask or in connectors that are near the mask.
2
During partial (below rated minimum voltage) or total power failure, therapy pressures will not be
delivered. When power is restored, operation can proceed with no change to settings.
CAUTION
A caution explains special measures for the safe and effective use of the device.
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When using accessories, read the manufacturer's User Manual. For consumables, important
information can be provided on the packaging, refer also to Symbols (see page 32).
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At low pressures, the flow through the mask vent holes may be inadequate to clear all exhaled
gas, and some rebreathing may occur.
2 or machine malfunction, remove the mask or the catheter mount
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