Teleflex LMA Supreme Instructions For Use

EN – English
Instructions For Use –
LMA Supreme™
CAUTION: Federal (USA) law restricts this
device to sale by or on the order of a physician.
WARNING: LMA Supreme™ is supplied sterile for
single use should be used straight from the pack
,
and should be discarded after use. It must not be re‐
used. Reuse may cause cross infection and reduce
product reliability and functionality.
WARNING: Re‐processing of LMA Supreme™
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
specifications are not available for this product.
LMA Supreme™ is not designed to be cleaned,
disinfected, or re‐sterilised.
1. DEVICE DESCRIPTION:
The LMA Supreme™ is an innovative, second
generation, single use supraglottic
management device.
The LMA Supreme™ provides access to and
functional separation of the respiratory and digestive
tracts. The anatomically shaped airway tube is
elliptical in cross section and ends distally at the
laryngeal mask. The inflatable cuff is designed to
conform to the contours of the hypopharynx, with
the bowl and the mask facing the laryngeal opening ‐
the First Seal™.
The LMA Supreme™ also contains a drain tube which
emerges as a separate port proximally and continues
distally along the anterior surface of the cuff bowl,
passing through the distal end of the cuff to
communicate distally with the upper oesophageal
sphincter ‐ the Second Seal™.
The drain tube may be used for the passage of a well
lubricated gastric tube to the stomach, offering easy
access for evacuation of gastric contents. The drain
tube has an additional and important function – it
may be used as a monitor of correct positioning of
the LMA Supreme™ following insertion and then for
continuous monitoring of mask displacement during
use.
The LMA Supreme™ provides easy insertion without
the need for digital or introducer tool guidance and
enough flexibility to permit the device to remain in
place if the patient's head is moved in any direction.
The two lateral grooves in the airway tube are
designed to prevent the airway tube kinking when
flexed. A built‐in bite‐block reduces the potential for
tube damage and obstruction by patient biting.
The LMA Supreme™ has a new fixation system which
prevents proximal displacement. If correctly used,
this enhance the seal of the distal end around the
upper oesophageal sphincter ‐ Second Seal™ thereby
isolating the respiratory tract from the digestive tract,
so reducing the danger of accidental aspiration.
Attached to the mask is a cuff inflation line
terminating in a pilot balloon and one‐way check
valve for mask inflation and deflation.
The LMA Supreme™ is made primarily of medical
grade polyvinylchloride (PVC) and is supplied sterile
for single use only. It is terminally sterilized by
Ethylene Oxide gas.
All components are not made with natural rubber
latex.
Figure 1: LMA Supreme™ components
LMA Supreme™ components (Figure 1):
(a) Anatomically‐shaped airway tube
(b) A separate drain tube has been incorporated
(c) I nflatable cuff with interlocking proximal and
distal segments
(d) Cuff inflation line
to original
(e) Pilot balloon
(f) A rigid moulded proximal component which forms
separate airway and drain tube ports
(g) Fixation tab
(h) Integral bite‐block
The device is only for use by medical professionals
trained in airway management.
airway
2. INDICATIONS FOR USE:
The LMA Supreme™ is indicated for use in achieving
and maintaining control of airway during routine and
emergency anaesthetic procedures in fasted patients
using either spontaneous or positive pressure
ventilation.
It is also indicated for use as the rescue airway device
in CPR procedures, in which the LMA ProSeal™, LMA
Classic™ or the LMA Unique™ have traditionally been
used. The LMA Supreme™ is also indicated as a
"rescue airway device" in known or unexpected
difficult airway situations. The LMA Supreme™ may
be used to establish an immediate clear airway
during resuscitation in the profoundly unconscious
patient with absent glossopharyngeal and laryngeal
reflexes who may need artificial ventilation.
It may also be used to secure an immediate airway
when tracheal intubation is precluded by lack of
available expertise or equipment, or when attempts
at tracheal intubation have failed.
3. RISK‐BENEFIT INFORMATION:
The benefits of establishing ventilation with the LMA
Supreme™ must be weighed against the potential
risk of aspiration in some situations including:
symptomatic or untreated gastro‐esophageal reflux,
pregnancy over 14 weeks, multiple or massive injury,
conditions associated with delayed gastric emptying,
such as the use of opiate medication in patients with
acute injury or peritoneal infections or inflammatory
processes.
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 LMA Supreme™ is the
preferential airway "rescue" device to ensure
oxygenation. The risk of regurgitation and aspiration
is minimized as the LMA Supreme™ offers easy
access to liquid gastric contents. However, the
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ultimate choice of the definite airway
device remains with the airway manager.
In patients with severe oropharyngeal trauma, the
device should only be used when other attempts to
establish an airway have failed
.
4. CONTRAINDICATIONS:
‐ Patients who have had radiotherapy to the neck
involving the hypopharynx (risk of trauma, failure to
seal effectively).
‐ Patients with inadequate mouth opening to permit
insertion.
‐ Patients presenting for emergency surgery who are
at risk of massive reflux, such as acute intestinal
obstruction or ileus, or patients having been injured
shortly after ingesting a substantial meal (but see
above under Indication for Use).
‐ Patients requiring head or neck surgery where the
surgeon cannot gain adequate access due to the
presence of the device.
‐ Responsive patients with an intact gag reflex.
‐ Patients who have ingested caustic substances.
5. WARNINGS:
5.1 In spite of encouraging case reports, it is not
currently known whether the LMA Supreme™
always affords protection from aspiration even
when correctly fixed in place.
5.2 The presence of a gastric tube does not rule out
the possibility of aspiration if the device is not
correctly located and fixed in place.
5.3 The LMA Supreme™ may be ineffective for use in
patients with decreased pulmonary compliance due
to fixed obstructive airways disease because airway
positive pressure requirement may exceed seal
pressure.
5.4 Do not attempt to pass a gastric tube into the
stomach via the drain tube in the presence of
known or suspected oesophageal pathology.
5.5 There is a theoretical risk of causing oedema or
haematoma if suction is applied directly to the end
of the drain tube.
5.6 To avoid trauma, excessive force should not be
used at any time when using the devices. Excessive
force must be avoided at all times.
5.7 This device contains Di (2‐ethylhexyl) phthalate
(DEHP). The results of certain animal experiments
have shown phthalates to be potentially toxic to
reproduction. Proceeding from the present state of
scientific knowledge, risks for male premature
infants cannot be excluded in the case of long‐term
exposure or application. Medical products
containing phthalates should be used only
temporarily with pregnant women, nursing mothers,
babies and infants.
5.8 Do not use the LMA Supreme™ if the device is
damaged or the unit packaging is damaged or
opened.
5.9 Never over‐inflate the cuff of the device over 60
cm H O. Excessive intra‐cuff pressure can result in
2
malposition and pharyngo‐laryngeal morbidity,
including sore throat, dysphagia and nerve injury.
5.10 Do not immerse or soak the device in liquid
prior to use.
5.11 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.
5.12. When applying lubricant avoid blockage of the
airway aperture with the lubricant.
5.13 A water‐soluble lubricant, such as K‐Y Jelly®,
should be used. Do not use silicone‐based
lubricants as they degrade LMA Supreme™
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
"rescue"