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INSTRUCTIONS FOR USE –
LMA Unique PreCurved™ & LMA Unique
PreCurved™ Cuff Pilot™
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician.
WARNING: LMA Unique PreCurved™ and LMA Unique PreCurved™ 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 PreCurved™ and LMA Unique
PreCurved™ 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 PreCurved™ and
LMA Unique PreCurved™ 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 PreCurved™ and LMA Unique PreCurved™ Cuff
Pilot™.
The devices are only for use by medical professionals trained in airway
management.
DEVICE DESCRIPTION:
Both the LMA Unique PreCurved™ and LMA Unique PreCurved™ Cuff Pilot™ are
not made with natural rubber latex and phthalates. They are supplied sterile
(sterilised by Ethylene Oxide) for single use only.
LMA Unique PreCurved™ and LMA Unique PreCurved™ Cuff Pilot™ provide easy
insertion without the need for digital or introducer tool guidance.
LMA Unique PreCurved™ and LMA Unique PreCurved™ Cuff Pilot™ have three
main components: airway tube, cuff and inflation system.
The inflation system of LMA Unique PreCurved™ consists of an Inflation Line with
Pilot Balloon and Check Valve for cuff inflation and deflation. The Pilot Balloon
provides a rough 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 PreCurved™ Cuff Pilot™ consists of an
Inflation Line with a Cuff Pilot™. The Cuff Pilot™ enables constant visualisation of
pressure inside the mask cuff. It replaces the standard pilot balloon and is to be
used in the same way for cuff inflation and deflation.
LMA Unique PreCurved™ is MR conditional. Refer to MRI information section prior
to using the device in MRI environment.
LMA Unique PreCurved™ Cuff Pilot™ is MR Safe. The term 'MR Safe' means that it
poses no known hazards in all MR environments.
Figure 1: The LMA Unique PreCurved™ components
LMA Unique PreCurved™ 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 PreCurved™ Cuff Pilot™ components
LMA Unique PreCurved™ Cuff Pilot™ components (Figure 2):
a)
Connector
b)
Airway Tube
c)
Backplate
d)
Cuff
e)
Inflation Line
f)
Cuff Pilot™
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