Page
3
of
5
6.
Careful
handling
is
essential.
Avoid
contact
with
sharp
or
pointed
objects
at
all
times
to
prevent
tearing
or
perforation
of
the
device.
Do
not
insert
the
device
unless
the
cuffs
are
fully
deflated
as
described
in
the
instructions
for
insertion.
7.
Gloves
should
be
worn
during
preparation
and
insertion
to
minimize
contamination
of
the
airway.
8.
Used
device
shall
follow
a
handling
and
elimination
process
for
bio
‐
hazard
products,
in
accordance
with
all
local
and
national
regulations.
9.
Store
the
device
in
a
dark
cool
environment,
avoiding
direct
sunlight
or
extremes
of
temperatures.
10.
Ensure
all
removable
denture
work
is
removed
before
inserting
the
device.
11.
An
unreliable
or
obstructed
airway
may
result
in
cases
where
the
device
has
been
incorrectly
inserted.
PREPARATION
FOR
USE:
Choose
the
correct
size
of
device.
Refer
to
Table
1
for
patient
weight
and
size
information.
Keep
a
clearly
marked
syringe
for
inflation
and
deflation
of
the
cuff.
PRE
‐
USE
CHECKS:
Warning:
It
is
most
important
that
pre
‐
use
checks
are
carried
out
on
the
device
prior
to
use,
in
order
to
establish
whether
they
are
safe
for
use.
Warning:
Failure
of
any
one
test
indicates
the
device
should
not
be
used.
These
tests
should
be
carried
out
as
follows:
1.
Examine
the
interior
of
the
airway
tube
to
ensure
it
is
free
from
blockage
or
loose
particles.
Examine
the
tube
throughout
its
length.
Should
any
cuts
or
indentations
be
found,
discard
the
device.
2.
Holding
at
each
end
flex
the
airway
tube
to
increase
its
curvature
up
to
but
not
beyond
180
o
.
Should
the
tube
kink
during
this
procedure,
discard
the
device.
3.
Deflate
the
cuff
fully.
For
LMA
Unique™
PreCurved™
Re
‐
inflate
the
device
with
a
volume
of
air
50%
greater
than
the
maximum
inflation
value
for
each
size.
Table
4:
Test
cuff
over
‐
inflation
volumes
Device
Size
1
1.5
2
2.5
3
4
5
Over
‐
inflation
cuff
volumes
(ml)
6
10
15
21
30
45
60
Examine
the
cuff
for
leaks,
herniations
and
uneven
bulging.
If
any
indications
of
these
problems
exist,
discard
the
device.
A
herniating
mask
may
cause
obstruction
during
use.
Then
deflate
the
mask
again.
While
the
device
remains
50%
over
‐
inflated,
examine
the
inflation
pilot
balloon.
The
balloon
shape
should
be
elliptical,
not
spherical.
For
LMA
Unique
PreCurved™
Cuff
Pilot™
Re
‐
inflate
the
device
to
Red
Zone
of
Cuff
Pilot™
(Fig
13)
with
a
volume
of
air
>
70cmH
2
0.
Examine
the
cuff
for
leaks,
herniations
and
uneven
bulging.
If
any
indications
of
these
problems
exist,
discard
the
device.
A
herniating
mask
may
cause
obstruction
during
use.
Then,
deflate
the
mask
again.
4.
Examine
the
airway
connector.
It
should
fit
securely
into
the
airway
tube
and
it
should
not
be
possible
using
reasonable
force,
to
remove.
Do
not
use
excessive
force
or
twist
the
connector
as
this
may
break
the
seal.
If
the
connector
is
loose,
discard
the
device
to
avoid
the
risk
of
accidental
disconnection
during
use.
5.
Discoloration.
Discoloration
affects
visibility
of
fluid
in
the
airway
tube.
6.
Gently
pull
the
inflation
line
to
ensure
it
is
securely
attached
to
both
the
cuff
and
balloon.
7.
Examine
the
aperture
in
the
mask.
Gently
probe
the
two
flexible
bars
traversing
the
mask
aperture
to
ensure
they
are
not
broken
or
otherwise
damaged.
If
the
aperture
bars
are
not
intact,
the
epiglottis
may
obstruct
the
airway.
Do
not
use
if
the
aperture
bar
is
damaged.
PRE
‐
INSERTION
PREPARATION:
Deflate
completely
using
the
LMA™
Cuff
Deflator
in
order
to
create
the
stiff
thin
leading
edge
necessary
to
wedge
the
tip
behind
the
cricoid
cartilage.
The
cuff
should
fold
back
away
from
the
aperture
bars.
Lubricate
the
back
of
the
cuff
thoroughly
just
before
insertion.
Do
not
lubricate
the
front
as
this
may
result
in
blockage
of
aperture
bar
or
aspiration
of
lubricant.
Warning:
A
water
‐
soluble
lubricant,
such
as
K
‐
Y
Jelly®,
should
be
used.
Do
not
use
silicone
‐
based
lubricants
as
they
degrade
the
device
components.
Lubricants
containing
Lidocaine
are
not
recommended
for
use
with
the
device.
Lidocaine
can
delay
the
return
of
the
patient’s
protective
reflexes
expected
prior
to
removal
of
the
device,
may
possibly
provoke
an
allergic
reaction,
or
may
affect
the
surrounding
structures,
including
the
vocal
cords.
Caution:
Ensure
all
removable
denture
work
is
removed
before
inserting
the
device.
INSERTION:
Caution:
Gloves
should
be
worn
during
preparation
and
insertion
to
minimize
contamination
of
the
airway.
Caution:
The
patency
of
this
device
should
be
reconfirmed
after
any
change
in
the
patient’s
head
or
neck
position.
1
.
Anaesthesia
must
be
deep
enough
to
permit
insertion.
Do
not
try
to
insert
immediately
following
barbiturate
induction,
unless
a
relaxant
drug
has
been
given.
2.
Hold
the
LMA
Unique
PreCurved™
in
position.
(Fig.
3)
Position
the
head
and
neck
as
for
normal
tracheal
intubation.
Place
the
head
in
the
neutral
or
slight
“sniffing”
position
(Sniffing
=
extension
of
head
+
flexion
of
neck)
by
pushing
the
head
from
behind
with
one
hand
while
inserting
the
mask
into
the
mouth
with
the
other
hand.
(Fig.
4)
3.
Press
the
distal
tip
against
the
inner
aspect
of
the
upper
teeth
or
gums.
(Fig.
5)
4.
Slide
inwards
using
a
slightly
diagonal
approach
(direct
the
tip
away
from
the
mid
‐
line).
(Fig.
6
)
5.
Continue
to
slide
inwards
rotating
the
hand
in
a
circular
motion
so
that
the
device
follows
the
curvature
behind
the
tongue.
(Fig.7)
6.
Resistance
should
be
felt
when
the
distal
end
of
the
device
meets
final
position
in
the
lower
pharynx.
The
device
is
now
fully
inserted.
(Fig.
8)
7.
Check
that
the
black
dotted
line
on
the
tube
faces
the
upper
lip.
Now
immediately
inflate
the
cuff
without
holding
the
tube.
(Fig.
9)
Do
this
BEFORE
connection
to
the
gas
supply.
This
will
permit
the
device
to
position
itself
correctly.
Inflate
the
cuff
with
sufficient
air
to
obtain
a
low
pressure
seal.
Refer
to
Table
5
for
inflation
information.
During
cuff
inflation,
do
not
hold
the
tube
as
this
prevents
the
device
from
settling
into
its
correct
location.
Warning:
NEVER
OVERINFLATE
THE
CUFF
.
Table
5:
Inflation
Information
Product
Recommended
Device
Size
1
1.5
2
2.5
3
4
5
LMA
Unique
PreCurved™
Maximum
Cuff
inflation
volume
(ml/60cmH
2
0)
4
7
10
14
20
30
40
LMA
Unique
PreCurved™
Cuff
Pilot™
Intracuff
pressure
(cmH
2
O)
60
60
60
60
60
60
60
8.
Connect
to
a
gas
supply,
holding
the
tube,
to
prevent
displacement.
Gently
inflate
the
lungs
to
confirm
correct
placement.
Insert
a
roll
of
gauze
as
bite
‐
block
(ensuring
adequate
thickness),
and
tape
the
device
into
place,
ensuring
that
the
proximal
end
of
the
airway
tube
is
pointing
caudally
(Fig.
10
).
When
correctly
placed,
the
tube
should
be
pressed
back
into
the
palate
and
posterior
pharyngeal
wall.
When
using
the
device,
it
is
important
to
remember
to
insert
a
bite
block
at
the
end
of
the
procedure.
Figure
5
:
Press
the
tip
of
the
mask
against
the
hard
palate
Figure
6
:
Press
the
cuff
further
into
the
mouth,
maintaining
pressure
against
the
palate.
Figure
3
:
Hold
the
LMA
Unique
PreCurved™
in
position
Figure
4
:
Position
the
head
and
neck
as
for
normal
tracheal
intubation.