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General warnings and cautions
WARNINGS
A warning alerts you to possible injury.
• Read the entire manual before using the device.
• T
his 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.
• T
he device and the accessories are to be used for the specified intended use only.
• T
he device must only be used with masks (and connectors
1
) recommended by
ResMed, or by a clinician or r
espiratory 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
1
)
which have 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.
• In the event of power failure
2
or machine malfunction, remove the mask or the
catheter mount from the trac
heostomy tube.
• Explosion hazard – do not use in the vicinit
y of flammable anesthetics.
• Do no
t use the device if there are obvious external defects, unexplained changes in
performance.
• Only use orignal and appro
ved ResMed accessories and parts.
•
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.
• 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.
•
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 (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively).
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.
• No modification of this equipment is allowed.
CAUTIONS
A caution explains special measures for the safe and effective use of the device.
• When
using accessories, read the manufacturer’s User Manual. For consumables
important information can be provided on the packaging, see also symbols on page 31.
• At
low pressures, the flow through the mask vent holes may be inadequate to clear all
exhaled gas, and some rebreathing may occur.
• T
he device may not be exposed to excessive force.
•
If the device should fall accidentally on the ground, please contact your authorised
service agent.
• Pay attention to leaks and other unusual sounds. If there is a problem, contact an
authorised service agent.
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 be proceeded with no change to settings.