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1
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EN
‐
English
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™
