Teleflex LMA Supreme User manual

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EN–English
InstructionsForUse–
LMASupreme™
CAUTION:Federal(USA)lawrestrictsthis
devicetosalebyorontheorderofaphysician.
WARNING:LMASupreme™issuppliedsterilefor
singleuse
,
shouldbeusedstraightfromthepack
andshouldbediscardedafteruse.Itmustnotbere‐
used.Reusemaycausecrossinfectionandreduce
productreliabilityandfunctionality.
WARNING:Re‐processingofLMASupreme™
intendedforsingleuseonlymayresultindegraded
performanceorlossoffunctionality.Re‐useof
singleuseonlyproductsmayresultinexposureto
viral,bacterial,fungal,orprionicpathogens.
Validatedcleaningandsterilisationmethodsand
instructionsforreprocessingtooriginal
specificationsarenotavailableforthisproduct.
LMASupreme™isnotdesignedtobecleaned,
disinfected,orre‐sterilised.
1.DEVICEDESCRIPTION:
TheLMASupreme™isaninnovative,second
generation,singleusesupraglotticairway
managementdevice.
TheLMASupreme™providesaccesstoand
functionalseparationoftherespiratoryanddigestive
tracts.Theanatomicallyshapedairwaytubeis
ellipticalincrosssectionandendsdistallyatthe
laryngealmask.Theinflatablecuffisdesignedto
conformtothecontoursofthehypopharynx,with
thebowlandthemaskfacingthelaryngealopening‐
theFirstSeal™.
TheLMASupreme™alsocontainsadraintubewhich
emergesasaseparateportproximallyandcontinues
distallyalongtheanteriorsurfaceofthecuffbowl,
passingthroughthedistalendofthecuffto
communicatedistallywiththeupperoesophageal
sphincter‐theSecondSeal™.
Thedraintubemaybeusedforthepassageofawell
lubricatedgastrictubetothestomach,offeringeasy
accessforevacuationofgastriccontents.Thedrain
tubehasanadditionalandimportantfunction–it
maybeusedasamonitorofcorrectpositioningof
theLMASupreme™followinginsertionandthenfor
continuousmonitoringofmaskdisplacementduring
use.
TheLMASupreme™provideseasyinsertionwithout
theneedfordigitalorintroducertoolguidanceand
enoughflexibilitytopermitthedevicetoremainin
placeifthepatient’sheadismovedinanydirection.
Thetwolateralgroovesintheairwaytubeare
designedtopreventtheairwaytubekinkingwhen
flexed.Abuilt‐inbite‐blockreducesthepotentialfor
tubedamageandobstructionbypatientbiting.
TheLMASupreme™hasanewfixationsystemwhich
preventsproximaldisplacement.Ifcorrectlyused,
thisenhancethesealofthedistalendaroundthe
upperoesophagealsphincter‐SecondSeal™thereby
isolatingtherespiratorytractfromthedigestivetract,
soreducingthedangerofaccidentalaspiration.
Attachedtothemaskisacuffinflationline
terminatinginapilotballoonandone‐waycheck
valveformaskinflationanddeflation.
TheLMASupreme™ismadeprimarilyofmedical
gradepolyvinylchloride(PVC)andissuppliedsterile
forsingleuseonly.Itisterminallysterilizedby
EthyleneOxidegas.
Allcomponentsarenotmadewithnaturalrubber
latex.
Figure1:LMASupreme™components
LMASupreme™components(Figure1):
(a)Anatomically‐shapedairwaytube
(b)Aseparatedraintubehasbeenincorporated
(c)Inflatablecuffwithinterlockingproximaland
distalsegments
(d)Cuffinflationline
(e)Pilotballoon
(f)Arigidmouldedproximalcomponentwhichforms
separateairwayanddraintubeports
(g)Fixationtab
(h)Integralbite‐block
Thedeviceisonlyforusebymedicalprofessionals
trainedinairwaymanagement.
2.INDICATIONSFORUSE:
TheLMASupreme™isindicatedforuseinachieving
andmaintainingcontrolofairwayduringroutineand
emergencyanaestheticproceduresinfastedpatients
usingeitherspontaneousorpositivepressure
ventilation.
Itisalsoindicatedforuseastherescueairwaydevice
inCPRprocedures,inwhichtheLMAProSeal™,LMA
Classic™ortheLMAUnique™havetraditionallybeen
used.TheLMASupreme™isalsoindicatedasa
“rescueairwaydevice”inknownorunexpected
difficultairwaysituations.TheLMASupreme™may
beusedtoestablishanimmediateclearairway
duringresuscitationintheprofoundlyunconscious
patientwithabsentglossopharyngealandlaryngeal
reflexeswhomayneedartificialventilation.
Itmayalsobeusedtosecureanimmediateairway
whentrachealintubationisprecludedbylackof
availableexpertiseorequipment,orwhenattempts
attrachealintubationhavefailed.
3.RISK‐BENEFITINFORMATION:
ThebenefitsofestablishingventilationwiththeLMA
Supreme™mustbeweighedagainstthepotential
riskofaspirationinsomesituationsincluding:
symptomaticoruntreatedgastro‐esophagealreflux,
pregnancyover14weeks,multipleormassiveinjury,
conditionsassociatedwithdelayedgastricemptying,
suchastheuseofopiatemedicationinpatientswith
acuteinjuryorperitonealinfectionsorinflammatory
processes.
Whenusedintheprofoundlyunresponsivepatientin
needofresuscitationorinadifficultairwaypatient
onanemergencypathway(i.e.“cannotintubate,
cannotventilate”)theLMASupreme™isthe
preferentialairway“rescue”devicetoensure
oxygenation.Theriskofregurgitationandaspiration
isminimizedastheLMASupreme™offerseasy
accesstoliquidgastriccontents.However,the
ultimatechoiceofthedefiniteairway“rescue”
deviceremainswiththeairwaymanager.
Inpatientswithsevereoropharyngealtrauma,the
deviceshouldonlybeusedwhenotherattemptsto
establishanairwayhavefailed
.
4.CONTRAINDICATIONS:
‐ Patientswhohavehadradiotherapytotheneck
involvingthehypopharynx(riskoftrauma,failureto
sealeffectively).
‐Patientswithinadequatemouthopeningtopermit
insertion.
‐Patientspresentingforemergencysurgerywhoare
atriskofmassivereflux,suchasacuteintestinal
obstructionorileus,orpatientshavingbeeninjured
shortlyafteringestingasubstantialmeal(butsee
aboveunderIndicationforUse).
‐ Patientsrequiringheadornecksurgerywherethe
surgeoncannotgainadequateaccessduetothe
presenceofthedevice.
‐Responsivepatientswithanintactgagreflex.
‐Patientswhohaveingestedcausticsubstances.
5.WARNINGS:
5.1Inspiteofencouragingcasereports,itisnot
currentlyknownwhethertheLMASupreme™
alwaysaffordsprotectionfromaspirationeven
whencorrectlyfixedinplace.
5.2Thepresenceofagastrictubedoesnotruleout
thepossibilityofaspirationifthedeviceisnot
correctlylocatedandfixedinplace.
5.3TheLMASupreme™maybeineffectiveforusein
patientswithdecreasedpulmonarycompliancedue
tofixedobstructiveairwaysdiseasebecauseairway
positivepressurerequirementmayexceedseal
pressure.
5.4Donotattempttopassagastrictubeintothe
stomachviathedraintubeinthepresenceof
knownorsuspectedoesophagealpathology.
5.5Thereisatheoreticalriskofcausingoedemaor
haematomaifsuctionisapplieddirectlytotheend
ofthedraintube.
5.6Toavoidtrauma,excessiveforceshouldnotbe
usedatanytimewhenusingthedevices.Excessive
forcemustbeavoidedatalltimes.
5.7ThisdevicecontainsDi(2‐ethylhexyl)phthalate
(DEHP).Theresultsofcertainanimalexperiments
haveshownphthalatestobepotentiallytoxicto
reproduction.Proceedingfromthepresentstateof
scientificknowledge,risksformalepremature
infantscannotbeexcludedinthecaseoflong‐term
exposureorapplication.Medicalproducts
containingphthalatesshouldbeusedonly
temporarilywithpregnantwomen,nursingmothers,
babiesandinfants.
5.8DonotusetheLMASupreme™ifthedeviceis
damagedortheunitpackagingisdamagedor
opened.
5.9Neverover‐inflatethecuffofthedeviceover60
cmH
2
O.Excessiveintra‐cuffpressurecanresultin
malpositionandpharyngo‐laryngealmorbidity,
includingsorethroat,dysphagiaandnerveinjury.
5.10Donotimmerseorsoakthedeviceinliquid
priortouse.
5.11Itismostimportantthatpre‐usechecksare
carriedoutonthedevicepriortouse,inorderto
establishwhetheritissafeforuse.Failureofany
onetestindicatesthedeviceshouldnotbeused.
5.12.Whenapplyinglubricantavoidblockageofthe
airwayaperturewiththelubricant.
5.13Awater‐solublelubricant,suchasK‐YJelly®,
shouldbeused.Donotusesilicone‐based
lubricantsastheydegradeLMASupreme™
components.LubricantscontainingLidocaineare
notrecommendedforusewiththedevice.
Lidocainecandelaythereturnofthepatient’s
protectivereflexesexpectedpriortoremovalofthe

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device,maypossiblyprovokeanallergicreaction,or
mayaffectthesurroundingstructures,includingthe
vocalcords.
5.14Diffusionofnitrousoxide,oxygen,orairmay
increaseordecreasecuffvolumeandpressure.In
ordertoensurethatcuffpressuresdonotbecome
excessive,cuffpressureshouldbemeasured
regularlyduringacasewithacuffpressuremonitor.
5.15Whenusingthedeviceinspecialenvironmental
conditions,suchasenrichedoxygen,ensurethatall
necessarypreparationandprecautionshavebeen
taken,especiallywithregardtofirehazardsand
prevention.Thedevicemaybeflammableinthe
presenceoflasersandelectrocauteryequipment.
5.16Refertosection18forMRIinformationpriorto
usingthedevicesinMRIenvironment.
6.CAUTIONS:
6.1Onlyusewiththerecommendedmanoeuvres
describedintheinstructionsforuse.
6.2Ifairwayproblemspersistorventilationis
inadequate,theLMASupreme™shouldberemoved
andanairwayestablishedbysomeothermeans.
6.3Carefulhandlingisessential.TheLMASupreme™
ismadeofmedical‐gradePVCwhichcanbetornor
perforated.Avoidcontactwithsharporpointed
objectsatalltimes.Donotinsertthedeviceunless
thecuffisfullydeflatedasdescribedinthe
instructionsforinsertion.
6.4Glovesshouldbewornduringpreparationand
insertiontominimizecontaminationoftheairway.
6.5Storethedeviceinadarkcoolenvironment,
avoidingdirectsunlightorextremesof
temperature.
6.6Useddeviceshallfollowahandlingand
eliminationprocessforbio‐hazardproducts,in
accordancewithalllocalandnationalregulations.
6.7Onlyuseasyringewithstandardluertapertipfor
inflation/deflationofthecuff.
6.8.Laryngealspasmmayoccurifthepatient
becomestoolightlyanaesthetizedduringsurgical
stimulationorifbronchialsecretionsirritatethe
vocalcordsduringemergencefromanaesthesia.If
laryngealspasmoccurs,treatthecause.Only
removethedevicewhenairwayprotectivereflexes
arefullycompetent.
6.9.Donotpulloruseundueforcewhenhandling
theinflationlineortrytoremovethedevicefrom
patientbytheinflationtubeasitmaydetachfrom
thecuffspigot.
6.10Ensureallremovabledentureworkisremoved
beforeinsertingthedevice.
6.11Anunreliableorobstructedairwaymayresultin
caseswherethedevicehasbeenincorrectly
inserted.
7.ADVERSEEFFECTS:
Therearereportedadversereactionsassociatedwith
theuseoflaryngealmaskairways.Standard
textbooksandpublishedliteratureshouldbe
consultedforspecificinformation.
8.SIZESELECTION:
Fornormaladults,usethesize4deviceasafirst
choice.Afterinserting,fixingthedeviceinplace,and
theninflatingtotherecommendedpressure,there
shouldbeaminimumofonecmgapbetweenthe
fixationtabandthepatient’supperlip.Ifthetabis
pressingontheliporveryneartoit,thisindicates
thedeviceistoosmallforthepatientandthesize5
shouldbeusedinsteadtoavoidtheriskof(a)poor
sealagainsttheoesophagusand(b)possible
pressuretraumatothelip.Ifthefixationtabismore
than2.5cmfromtheupperlipafterfixation,itmay
beadvisabletousethesize3device.Thedecisionto
changetoasmallerdevicewilldependonthequality
ofairway,devicestabilityandsealpressureachieved.
.
Figure2:LMASupreme™sizing
Figure3:LMASupreme™sizing(method2)
Thesizingmethoddescribedaboverequiresthatall
threeadultsizesoftheLMASupreme™shouldbe
availabletohandbeforeinducinganaesthesia.
Foradultpatientswhoareeithersmallerorlarger
thannormal,itisoftenpossibletoobtainagood
resultusingthesize4device,providedthequantity
ofairusedtoinflatethecuffisalwaysbasedon
achieving60cmH₂Ointracuffpressure.Insmaller
patientsthispressureisachievedwitharelatively
smallvolumeofair,whilelargerpatientswillrequire
largervolumes.However,whenindoubt,an
approximateestimateofsuitablesizingcanbemade
byholdingeachdeviceagainstthesideofthe
patient’sfaceinthepositioncorrespondingtothat
showninFigure3.
9.PRE‐USEPERFORMANCETESTS:
Thefollowinginspectionsandtestsmustbe
conductedbeforeuseofthedevice.The
performancetestsshouldbeconductedinanarea
andinamannerconsistentwithacceptedmedical
practicethatminimisecontaminationoftheLMA
Supreme™beforeinsertion.
Warning:Donotusethedeviceshoulditfailsany
oneoftheinspectionsortests.
•ExaminethesurfaceoftheLMASupreme™and
draintubefordamage,includingcuts,tears,
scratchesorkinks.
•Examinetheinterioroftheairwaytubeanddrain
tubetoensuretheyarefreefromblockages
kinkingofthedraintubewithintheairwaytube
orlooseparticles.Anyparticlespresentinthe
tubesshouldberemoved.Donotusetheairway
iftheblockageorparticlecannotberemoved.
•Deflatethecuffcompletely.Oncedeflated,check
thecuffforspontaneousinflation.Donotuse
theairwayifthecuffspontaneouslyinflates.
10.DEFLATINGTHEDEVICEPRIORTO
INSERTION:
‐Afterfirmlyconnectingasyringeofatleast50mlto
theinflationport,holdthesyringeandtheLMA
Supreme™exactlyasshowninFigure4.Movethe
connectedsyringeawayfromthedeviceuntilthe
inflationlineisslightlystretchedasshown.
Compressthedistalendofthedeviceinbetween
theindexfingerandthumbwhilewithdrawingair
untilavacuumhasbeenobtained.
‐ Whiledeflating,holdthedevicesothatthedistal
endiscurledslightlyanteriorlyasshowninFigure4
‐ Deflatethedeviceuntilthetensioninthesyringe
indicatesavacuumhasbeencreatedinthemask.
Keepthesyringeundertensionwhilstrapidly
disconnectingitfromtheinflationport.Thiswill
ensurethemaskremainscorrectlydeflated,as
showninFig5.
Figure4:LMASupreme™ Figure5:Afterachieving
deflation
wedgeshapecuffduring
deflation,disconnectthe
syringefromtheinflation
line
11.INSERTION:
Caution:Thepatencyoftheairwayshouldbe
reconfirmedafteranychangeinthepatient’shead
andneckposition.
‐ Lubricatetheposteriorsurfaceofthemaskand
airwaytubejustpriortoinsertion.
‐Standbehindorbesidepatient’shead.
‐ Placetheheadintheneutralorslight“sniffing”
position(Sniffing=extensionofhead+flexionof
neck).
‐HoldthedeviceexactlyasshowninFigure6.
‐ Pressthedistaltipagainsttheinneraspectofthe
upperteethorgums.
‐ Slideinwardsusingaslightlydiagonalapproach
(directthetipawayfromthemid‐line).
‐ Continuetoslideinwardsrotatingthehandina
circularmotionsothatthedevicefollowsthe
curvaturebehindthetongue.
‐Resistanceshouldbefeltwhenthedistalendofthe
devicemeetstheupperoesophagealsphincter.The
deviceisnowfullyinserted.
Figure6:PressthetipoftheFigure7:Pressthecufffurther
maskagainstthehardpalate.intothemouth,maintaining
pressureagainstthepalate.
Figure8:SwingthedeviceinwardFigure9:Advancethedevice
withacircularmotion,pressingintothehypopharynxuntil
againstthecontoursofthehardresistanceisfelt.
andthesoftpalate.
12.FIXATION:
SecuretheLMASupreme™topatient’sfaceusing
adhesivetapeasfollows:
‐Useapieceofadhesivetape30‐40cmlong,holding
ithorizontallybybothends
‐ Presstheadhesivetapetransverselyacrossthe
fixationtab,continuingtopressdownwardssothat
theendsofthetapeadheretoeachofthepatient’s
cheeksandthedeviceitselfisgentlypressed
inwardsbythetape
‐Donotrotatethetapearoundtheproximalendof
thedevice
‐ DonotuseaGuedelairway;thedevicehasan
integralbiteblock

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Figure10a
Figure10b
Figure10:Fixthedeviceinplaceusingadhesivetape.
Stretchedtheadhesivetapeverticallydownwards(See
Figure10a)ensurethatthemiddleofthetapeispressed
verticallydownwardsoverthetabasshowninFigure10b.
13.INFLATION:
Inflatethecuffwithairuntilrelevantintra‐cuff
pressureisreached.Therecommendedintra‐cuff
pressureshouldneverexceed60cmH₂O.Ifno
manometerisbyhand,inflatewithjustenoughairto
achieveasealsufficienttopermitventilationwithout
leaks.
Air‐
way
Size
Patient
Weight
(kg)
Max
Size
OG
Tube
Recommended
Maximum
Inflation
Volume
Optimum
Intra‐Cuff
Pressure
1<56Fr5ml
60cm
H₂O
1.55‐106Fr8ml
210‐2010Fr12ml
2.520‐3010fr20ml
330‐5014Fr30ml
450‐7014Fr45ml
570‐10014Fr45ml
Table1:LMASupreme™selectionguide
14.CORRECTPOSITION:
Correctplacementshouldproducealeak‐freeseal
againsttheglottiswiththemasktipattheupper
oesophagealsphincter.Theintegralbiteblockshould
liebetweentheteeth.
Tofacilitatediagnosisofcorrectmaskplacement,
placeasmallbolus(1‐2ml)ofsuitablyviscouswater
solublelubricantintheproximalendofthedrain
tube.Inaproperlyplacedmask,thereshouldbea
slightup‐downmeniscusmovementofthelubricant
followingtheapplicationandreleaseofgentle
pressureinthesuprasternalnotch.Thisindicates
thatthedistalendofthedraintubeiscorrectly
placedsothatitsealsaroundtheupperoesophageal
sphincter(the‘suprasternalnotchtest’).Asimilar
movementmayalsobeseenwhengentlemanual
positivepressureisappliedtotheairwaythroughthe
device.
15.GASTRICDRAINAGE:
Thedraintubefacilitateschannelingoffluidsand
gasesemergingfromthestomach.Tofacilitate
gastricdrainage,agastrictubemaybepassed
throughthedraintubeintothestomachatanytime
duringtheanaestheticprocedure.RefertoTable1
formaximumgastrictubesizes.Thegastrictube
shouldbewelllubricatedandpassedslowlyand
carefully.Suctionshouldnotbeperformeduntilthe
gastrictubehasreachedthestomach.Suctionshould
notbeapplieddirectlytotheendofthedraintube,
asthismaycausethedraintubetocollapseand
mighttheoreticallycauseinjurytotheupper
oesophagealsphincter.
16.ANAESTHESIAMAINTENANCE:
TheLMASupreme™iswelltoleratedin
spontaneouslybreathingpatientswhenusedwith
volatileagentsorintravenousanaesthesia,provided
anaesthesiaisadequatetomatchthelevelofsurgical
stimulusandthecuffisnotover‐inflated.
DuringPositivePressureVentilation(PPV)usingthe
LMASupreme™tidalvolumesshouldnotexceed
8ml/kgandpeakinspiratorypressuresshouldbe
keptbelowthemaximumairwaysealpressure.
IfleaksoccurduringPPV,thismaybeduetolight
anaesthesiacausingadegreeofglottisclosure,
severereductioninlungcompliancerelatedtothe
procedureorpatientfactorsordisplacementor
migrationofthecuffbyheadturningortractioninan
inadequatelyfixedmask.
17.RECOVERY:
Removalshouldalwaysbecarriedoutbytrained
personnel.Althoughthedevicemaynotberemoved
intheoperatingtheatre,itslowinvasivitymakesita
gooddevicetomaintaintheairwayduringrecovery
inthePostAnaestheticCareUnit(PACU)provided
staffareappropriatelytrainedandequipped.
Becauserecoveryinvolvesincreaseinpharyngeal
tone,itmakessensetoreducethevolumeofairin
thecuffbeforesendingthepatienttothePACU;
however,thecuffmustneverbefullydeflatedatthis
point.
Fullydeflatethecuffandsimultaneouslyremovethe
deviceONLYwhenthepatientcanopenthemouth
oncommand.IfthecuffisFULLYdeflatedbeforethe
returnofeffectiveswallowingandcoughreflexes,
secretionsintheupperpharynxmayenterthe
larynx,provokingcoughingorlaryngealspasm.
Patientmonitoringshouldcontinuethroughoutthe
recoverystage.Whereappropriate,oxygenmaybe
continuouslyadministeredthroughtheanaesthetic
circuitorviaaT‐pieceattachedtotheproximalend
oftheairwaydevice.
18.USEWITHMAGNETICRESONANCE
IMAGING(MRI):
TheLMASupreme™isMRConditional.Non‐clinical
testingdemonstratedthattheLMASupreme™isMR
Conditional.Apatientwiththisdevicecanbe
scannedsafely,immediatelyafterplacementunder
thefollowingconditions:
BeforethepatiententerstheMRIsystemroom,
theairwaymustbefixedproperlyinplacewith
adhesivetape,clothtapeorotherappropriate
meanstopreventmovementordislodgement.
Staticmagneticfieldof3‐Teslaorless.
Maximumspatialgradientmagneticfieldof
720gauss/cm(7.2T/m)orless.
MaximumMRsystemreported,wholebody
averagedspecificabsorptionrate(SAR)of4‐
W/kg(FirstLevelControlledOperatingModeof
operationfortheMRIsystem)for15min.of
scanning(perpulsesequence).
MRI‐RelatedHeating
Underthescanconditionsdefinedabove,theLMA
Supreme™isexpectedtoproduceamaximum
temperatureriseof2.2Cafter15minutesof
continuousscanning.
ArtifactInformation
Themaximumartifactsizeasseenonagradientecho
pulsesequenceanda3‐TeslaMRIsystemextends
approximately20‐mmrelativetothesizeandshape
oftheLMASupreme™,Size5.
19.SYMBOLSDEFINITION:
Manufacturer
ConsultIFUonthiswebsite:
www.LMACO.com
Airinflationvolume
Patientweight
ReadInstructionsbeforeuse
Notmadewithnaturalrubber
latex
Fragile,handlewithcare
Keepawayfromsunlight
Keepdry
Thiswayup
ProductCode
LotNumber
CEMark
DonotRe‐use
DonotRe‐sterilise
ContainsorPresenceof
Phthalates:
Bis(2‐ethylhexyl)phthalate
(DEHP)
SterilisedbyEthyleneOxide
UseBy
Donotuseifpackageis
damaged
MRConditional

Page4of4
Copyright©2015TeleflexIncorporated
Allrightsreserved.Nopartofthispublicationmaybe
reproduced,storedinaretrievalsystemor
transmittedinanyformorbyanymeanselectrical,
mechanical,photocopying,recordingorotherwise,
withoutthepriorpermissionofthepublisher.
LMA,LMABetterbyDesignandLMASupremeare
trademarksorregisteredtrademarksofTeleflex
Incorporatedoritsaffiliates.TheLMASupreme™is
protectedbyaseriesofgrantedandpendingpatents.
Theinformationgiveninthisdocumentiscorrectat
thetimeofgoingtopress.Themanufacturer
reservestherighttoimproveormodifytheproducts
withoutpriornotification.
Consulttheinstructionsonindications,
contraindications,warningsandprecautions,or
informationonwhichLMA™airwaysarebestsuited
fordifferentclinicalapplications.
Manufacturer’sWarranty:
TheLMASupreme™isdesignedforasingleuseand
warrantedagainstmanufacturingdefectsatthetime
ofdelivery.
Warrantyisapplicableonlyifpurchasedfroman
authorizeddistributor.TELEFLEXINCORPORATED
DISCLAIMSALLOTHERWARRANTIES,WHETHER
EXPRESSORIMPLIED,INCLUDING,WITHOUT
LIMITATION,THEWARRANTIESOF
MERCHANTABILITYORFITNESSFORAPARTICULAR
PURPOSE.
TeleflexMedical
IDABusinessandTechnologyPark
DublinRoad,Athlone
Co.Westmeath,Ireland
ContactInformationinUSA:
TeleflexMedical
2917WeckDrive,ResearchTrianglePark
NC27709USA
International:(919)544‐8000
USA:(866)246‐6990
www.LMACO.com
Issue:PAJ‐2100‐002RevBUK
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