Page
2
of
5
Table
1
:
Specification
for
the
device
Device
Size
1
1.5
2
2.5
3
4
5
Patient
Weight
(kg)
Up
to
5
5
‐
10
10
‐
20
20
‐
30
30
‐
50
50
‐
70
70
‐
100
Airway
Connector
15
mm
male
(ISO
5356
‐
1)
Inflation
Valve
Luer
cone
(ISO
594
‐
1)
Internal
Volume
of
ventilator
pathway
(ml)
4
5
8
10
19
19
27
Pressure
drop
(mm
H
2
O)
<
22
at
15
l/min
<
10
at
15
l/min
<
20
at
30
l/min
<
10
at
30
l/min
<
16
at
60
l/min
<
16
at
60
l/min
<
12
at
60
l/min
Min.
interdental
gap
(mm)
16
18
21
24
29
30
34
Normal
length
of
the
internal
ventilatory
pathway
(cm)
12.0
13.5
15.5
16.5
22.0
22.0
24.0
A
summary
of
the
methods,
materials,
data
and
results
of
clinical
studies
that
validate
the
requirements
of
this
international
standard
is
available
on
request,
if
applicable.
Correct
Position
of
the
device
in
relation
to
anatomical
landmarks
Table
2
:
Description
of
anatomical
landmarks
Anatomical
Landmarks
1
‐
Esophagus
7
‐
Hyoid
bone
2
‐
Trachea
8
‐
Tongue
3
‐
Cricoid
cartilage
9
‐
Buccal
cavity
4
‐
Thyroid
cartilage
10
‐
Nasopharynx
5
‐
Laryngeal
inlet
11
‐
Incisors
6
‐
Epiglottis
Table
3:
Description
of
the
device
parts
a
‐
Patient
end
d
‐
Ventilatory
pathway
b
‐
Ventilatory
opening
e
‐
External
end
connector
c
‐
Sealing
mechanism
INDICATION
FOR
USE:
The
LMA
Unique
PreCurved™
and
LMA
Unique
PreCurved™
Cuff
Pilot™
are
indicated
for
use
in
achieving
and
maintaining
control
of
the
airway
during
routine
anaesthetic
procedures
in
fasted
patients
using
either
spontaneous
or
Positive
Pressure
Ventilation
(PPV).
They
are
also
indicated
for
securing
the
immediate
airway
in
known
or
unexpected
difficult
airway
situations.
They
are
suited
for
use
in
elective
surgical
procedures
where
tracheal
intubation
is
not
necessary.
They
may
be
used
to
establish
an
immediate,
clear
airway
during
cardiopulmonary
resuscitation
(CPR)
in
the
profoundly
unconscious
patient
with
absent
glossopharyngeal
and
laryngeal
reflexes
requiring
artificial
ventilation.
In
these
cases,
the
devices
should
be
used
only
when
tracheal
intubation
is
not
possible.
RISK
‐
BENEFIT
INFORMATION:
When
used
in
the
profoundly
unresponsive
patient
in
need
of
resuscitation
or
in
a
difficult
airway
patient
on
an
emergency
pathway
(i.e.,
“cannot
intubate,
cannot
ventilate”),
the
risk
of
regurgitation
and
aspiration
must
be
weighed
against
the
potential
benefit
of
establishing
an
airway.
CONTRAINDICATIONS:
Due
to
the
potential
risk
of
regurgitation
and
aspiration,
do
not
use
the
device
as
a
substitute
for
an
endotracheal
tube
in
the
following
elective
or
difficult
airway
patients
on
a
non
‐
emergency
pathway:
1.
Patients
who
have
not
fasted,
including
patients
whose
fasting
cannot
be
confirmed.
2.
Patients
who
are
morbidly
obese,
more
than
14
weeks
pregnant
or
emergency
and
resuscitation
situations
or
any
condition
associated
with
delayed
gastric
emptying,
or
using
opiate
medication
prior
to
fasting.
3.
Patients
with
inadequate
mouth
opening
to
permit
insertion.
The
device
is
also
contraindicated
in:
1.
Patients
with
fixed
decreased
pulmonary
compliance,
or
peak
insufflation
pressure
anticipated
to
exceed
20
cm
H
2
O,
because
the
device
forms
a
low
‐
pressure
seal
(approximately
20
cm
H
2
O)
around
the
larynx.
2.
Adult
patients
who
are
unable
to
understand
instructions
or
cannot
adequately
answer
questions
regarding
their
medical
history,
since
such
patients
may
be
contraindicated
for
the
device.
3.
The
device
should
not
be
used
in
the
resuscitation
or
emergency
situation
in
patients
who
are
not
profoundly
unconscious
and
who
may
resist
device
insertion.
ADVERSE
EFFECTS:
There
are
reported
adverse
reactions
associated
with
the
use
of
laryngeal
mask
airways.
Standard
textbooks
and
published
literature
should
be
consulted
for
specific
information.
WARNINGS:
1.
To
avoid
trauma,
excessive
force
must
be
avoided
at
all
times.
2.
Do
not
use
if
the
device
is
damaged
or
its
unit
packaging
is
damaged
or
opened.
3.
When
using
the
device
in
special
environmental
conditions,
such
as
enriched
oxygen,
ensure
that
all
necessary
preparation
and
precautions
have
been
taken,
especially
with
regard
to
fire
hazards
and
prevention.
The
device
may
be
flammable
in
the
presence
of
lasers
and
electrocautery
equipment.
4.
It
is
most
important
that
pre
‐
use
checks
are
carried
out
on
the
device
prior
to
use,
in
order
to
establish
whether
it
is
safe
for
use.
Failure
of
any
one
test
indicates
the
device
should
not
be
used.
5.
Do
not
immerse
or
soak
the
device
in
liquid
prior
to
use.
6.
When
applying
lubricant
avoid
blockage
of
the
airway
aperture
with
the
lubricant.
7.
Never
overinflate
the
cuff
over
60cm
H
2
O.
Excessive
intra
‐
cuff
pressure
can
result
in
malposition
and
pharyngo
‐
laryngeal
morbidity,
including
sore
throat,
dysphagia
and
nerve
injury.
8.
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.
9.
The
device
does
not
prevent
regurgitation
or
aspiration.
Its
use
in
anaesthetised
patients
should
be
restricted
to
fasting
patients.
A
number
of
conditions
predispose
to
regurgitation
under
anaesthesia.
Do
not
use
the
devices
without
taking
appropriate
precautions
to
ensure
the
stomach
is
empty.
10.
Diffusion
of
nitrous
oxide,
oxygen,
or
air
may
increase
or
decrease
cuff
volume
and
pressure.
In
order
to
ensure
that
cuff
pressures
do
not
become
excessive,
cuff
pressure
should
be
measured
regularly
during
a
case
with
a
cuff
pressure
monitor.
11.
Refer
to
MRI
information
section
prior
to
using
the
devices
in
MRI
environment.
CAUTIONS:
1.
Laryngeal
spasm
may
occur
if
the
patient
becomes
too
lightly
anaesthetized
during
surgical
stimulation
or
if
bronchial
secretions
irritate
the
vocal
cords
during
emergence
from
anaesthesia.
If
laryngeal
spasm
occurs,
treat
the
cause.
Only
remove
the
device
when
airway
protective
reflexes
are
fully
competent.
2.
Do
not
pull
or
use
undue
force
when
handling
the
inflation
line
or
try
to
remove
the
device
from
patient
by
the
inflation
line
as
it
may
detach
from
the
cuff
spigot.
3.
Only
use
a
syringe
with
standard
luer
taper
tip
for
inflation
or
deflation.
4.
Only
use
with
the
recommended
manoeuvres
described
in
the
instructions
for
use.
5.
If
airway
problems
persist
or
ventilation
is
inadequate,
the
device
should
be
removed
and
an
airway
established
by
some
other
means.
