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EN – English
INSTRUCTIONS FOR USE –
LMA
Unique™ (S) & LMA
Unique™ (S)
Cuff Pilot™
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician.
WARNING: LMA
Unique™ (S) and LMA
Unique™ (S)
Cuff Pilot
™
are
supplied
sterile for single use only, should be used straight from the pack and should be
discarded after use. They must not be re-used. Reuse may cause cross infection
and reduce product reliability and functionality.
WARNING: Re-processing of LMA
Unique™ (S) and LMA
Unique™ (S)
Cuff
Pilot
™ intended for single use only may result in degraded performance or loss
of functionality. Re-use of single use only products may result in exposure to
viral, bacterial, fungal, or prionic pathogens. Validated cleaning and sterilisation
methods and instructions for reprocessing to original specifications are not
available for these products. LMA
Unique™ (S) and LMA
Unique™ (S)
Cuff
Pilot
™ are not designed to be cleaned, disinfected, or re-sterilised.
GENERAL INFORMATION:
Unless otherwise stated, the reference to “device” stated on this IFU applies to
both versions of LMA
Unique™ (S) & LMA
Unique™ (S)
Cuff Pilot™
.
The devices are only for use by medical professionals trained in airway
management.
DEVICE DESCRIPTION:
Both LMA
Unique™ (S) and LMA
Unique™ (S)
Cuff Pilot
™ are made primarily of
silicone and are supplied sterile (sterilised by Ethylene Oxide) for single use only.
The devices are not made with natural rubber latex and phthalates.
LMA
Unique™ (S) and LMA
Unique™ (S)
Cuff Pilot™
have three main
components: airway tube, cuff and inflation system.
The inflation system of LMA
Unique™ (S) consists of an Inflation Line with Pilot
Balloon and Check Valve for cuff inflation and deflation. The Pilot Balloon provides
an indication of the pressure within the cuff and the Check Valve prevents leakage
of air and maintains the pressure in cuff.
The inflation system of LMA
Unique™ (S)
Cuff Pilot™
consists of an Inflation Line
with Cuff Pilot™ technology. Cuff Pilot™ technology enables constant visualisation
of inside mask cuff pressure. It replaces the standard pilot balloon and to be used
in the same way for cuff inflation and deflation.
LMA
Unique™ (S) is MR conditional. Refer to MRI information section prior using
the device in MRI environment.
LMA
Unique™ (S)
Cuff Pilot™
is MR Safe. The term ‘MR Safe’ means that it poses
no known hazards in all MR environments.
Figure 1:
LMA
Unique™ (S) components
LMA
Unique™ (S) components
(Figure 1):
a)
Connector
b)
Airway Tube
c)
Backplate
d)
Cuff
e)
Inflation Line
f)
Pilot Balloon
g)
Check Valve
Figure 2:
LMA
Unique™ (S)
Cuff Pilot
™ components
LMA
Unique™ (S)
Cuff Pilot™
components (
Figure 2
):
a)
Connector
b)
Airway Tube
c)
Backplate
d)
Cuff
e)
Inflation Line
f)
Cuff Pilot™
