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31General warnings and cautions
English
• The device must only be used with masks (and connectors
1
) recommended by
ResMed, or by a clinician or respiratory ther
apist. 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 tracheo
stomy tube.
• Explosion hazard – do not use in the vicinity
of flammable anesthetics.
• Do not use the device if there are obvious e
xternal defects, unexplained changes in
performance.
• Only use orignal and approv
ed 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.
CAUTIONS
A caution explains special measures for the safe and effective use of the device.
• When using accessories, read the manufact
urer’s User Manual. For consumables
important information can be provided on the packaging, see also symbols on page 30.
• At low pressures, the flow through the mask v
ent holes may be inadequate to clear all
exhaled gas, and some rebreathing may occur.
• The 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.
Notes:
A note advises to special product features.
• The above are general warnings and cautions. Furth
er specific warnings, cautions and
notes appear next to the relevant instructions in the user guide.
• Only trained and authorised personnel are allowed
to make clinical setting changes.
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
delive
red. When power is restored, operation can be proceeded with no change to settings.