POWER INJECTABLE IMPLANTABLE INFUSION

PORT

DESCRIPTION:

• ThePowerInjectableImplantableInfusionPort isanimplantableaccessdevicedesignedto providerepeatedaccesstothevascularsystem. Portaccessisperformedbypercutaneous needleinsertionusinganon-coringneedle. Power injection is performed using a power injectable needle only. ThePowerInjectable ImplantableInfusionPortdeviceconsistsoftwo primarycomponents:aninjectionportwitha self-sealingsiliconeseptumandaradiopaque catheter.ImplantableInfusionPortscanbe identifiedsubcutaneouslybyfeelingthetopof theseptumandthetoprimoftheporthousing. PowerInjectableImplantableInfusionPorts canbeidentifiedbytheletters“CT”under radiographicimaging.

• All materials are biocompatible, can be used with virtually all injectable solutions, are latex-free, and safe with CECT and MRI imaging.

INDICATIONS FOR USE:

• ThePowerInjectableImplantableInfusionPort isindicatedforpatienttherapiesrequiring repeatedaccesstothevascularsystem.The portsystemcanbeusedforinfusionof medications,I.V.fluids,parenteralnutrition solutions,bloodproducts,andforthe withdrawalofbloodsamples.

• Whenusedwithapowerinjectableneedle,the PowerInjectableImplantableInfusionPort deviceisindicatedforpowerinjectionof contrastmedia.Forpowerinjectionofcontrast media,themaximumrecommendedinfusion rateis5ml/switha19or20gaugenon-coring powerinjectableneedle.

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

CONTRAINDICATIONS:

• Thisdeviceiscontraindicatedforcatheter insertioninthesubclavianveinmedialtothe borderofthefirstrib,anareawhichis associatedwithhigherratesofpinch-off.1,2

• Thedeviceisalsocontraindicated: • Whenthepresenceofdevicerelated infection,bacteremia,orsepticemiais knownorsuspected. • Whenthepatient’sbodysizeisinsufficient forthesizeoftheimplanteddevice. • Whenthepatientisknownorissuspected tobeallergictomaterialscontainedinthe device. • Ifseverechronicobstructivelungdisease exists. • Iftheprospectiveinsertionsitehasbeen previouslyirradiated. • Iftheprospectiveplacementsitehas previouslysufferedepisodesofvenous thrombosisorvascularsurgical procedures. • Iflocaltissuefactorswillpreventproper devicestabilizationand/oraccess.

WARNINGS:I. During Placement: • IntendedforSingle Patient Use. DO NOT REUSE. Medcomp®productsaresingleuse devicesandshouldneverbereimplanted.Any devicethathasbeencontaminatedbybloodshould notbereusedorresterilized.

INSTRUCTIONS FOR USE

• Afteruse,thisproductmaybeapotential biohazard.Handleanddiscardinaccordance withacceptedmedicalpracticeandapplicable local,stateandfederallawsandregulations.• Duringplacementthroughasheath,hold thumboverexposedopeningofsheathto preventairaspiration.Theriskofair aspirationisreducedbyperformingthispartof theprocedurewiththepatientperformingthe Valsalvamaneuver.• Donotsuturecathetertoport.Anydamageor constrictionofcathetermaycompromisepower injectionperformance.• Avoidvesselperforation.• Donotpowerinjectthroughaportsystem that exhibitssignsofclavicle-firstrib compressionorpinch-offasitmayresultin portsystemfailure.

II. During Port Access: • DONOTUSEASYRINGESMALLERTHAN 10ml.Prolongedinfusionpressuregreaterthan 25psimaycausedamagetoapatient’svessels orviscus.• Power Injectable Implantable Infusion Ports are only power injectable when accessed with a power injectable needle. • Failuretowarmcontrastmediatobody temperaturepriortopowerinjectionmayresult inportsystemfailure.• Failuretoensurepatencyofthecatheterprior topowerinjectionstudiesmayresultinport systemfailure.• Powerinjectormachinepressurelimiting featuremaynotpreventoverpressurizationof anoccludedcatheter.• Exceedingthemaximumflowratemayresult inportsystemfailureand/orcathetertip displacement.• PowerInjectableImplantableInfusionPort deviceindicationforpowerinjectionofcontrast mediaimpliesthePort’sabilitytowithstandthe procedure,butdoesnotimplyappropriateness oftheprocedureforaparticularpatientnorfor aparticularinfusionset.Asuitablytrained clinicianisresponsibleforevaluatingthe healthstatusofapatientasitpertainstoa powerinjectionprocedureandforevaluating thesuitabilityofanyinfusionsetusedto accesstheport. • Donotexceeda300psipressurelimitsetting, orthemaximumflowratesettingonthepower injectionmachine,ifpowerinjectingthrough thePowerInjectableImplantableInfusionPort device.• Medicalproceduresonapatient’sarminwhich thesystemisimplantedshouldberestrictedas follows: • Do notwithdrawbloodfromorinfuse medicationintoanyareaofthearmwhere thesystemislocatedunlessyouareusing theport • Do notmeasurethepatient’sbloodpressure onthisarm

SIGNSOFPINCH-OFF:

Clinical: • Difficultywithbloodwithdrawal • Resistancetoinfusionoffluids • Patientpositionchangesrequiredfor infusionoffluidsorbloodwithdrawal

Radiologic: • Grade 1 or 2 distortion on chest x-ray. Pinch-off should be evaluated for degree of severity prior to explantation. Patients indicating any degree of catheter distortion at theclavicle/firstribareashouldbefollowed diligently. There are grades of pinch-off that shouldberecognizedwithappropriatechest x-rayasfollows:3,4

Grade Severity Recommended Action

Grade0 Nodistortion Noaction

Grade1

Distortionpresentwithoutluminalnarrowing

Chestx-rayshouldbetakeneveryonetothreemonthstomonitorprogressionofpinch-offtograde2distortion.Shoulderpositioningduringchestx-raysshouldbenotedasitcancontributetochangesindistortiongrades.

Grade2

Distortionpresentwith luminalnarrowing

Removalofthecathetershouldbeconsidered.

Grade3Cathetertransectionorfracture

Promptremovalofthecatheter.

PRECAUTIONS:

• Carefullyreadandfollowallinstructionsprior touse.• Federal(U.S.A.)lawrestrictsthisdevicetosale byorontheorderofaphysician.• Onlyqualifiedhealthcarepractitionersshould insert,manipulateandremovethesedevices.• Avoidinadvertentpunctureoftheskinorfascia withthetipofthetunneler.• Iftheguidewiremustbewithdrawnwhilethe needleisinserted,removeboththeneedleand wireasaunittohelppreventtheneedlefrom damagingorshearingtheguidewire.• Useonlynon-coringneedleswiththeport.• Priortoadvancingthecatheterlock,ensure thatthecatheterisproperlypositioned.A catheternotadvancedtotheproperregionmay notseatsecurelyandleadtodislodgmentand extravasation.Thecathetermustbestraight withnosignofkinking.Aslightpullonthe catheterissufficienttostraightenit.Advancing thecatheterlockoverakinkedcathetermay damagethecatheter.• FollowUniversalPrecautionswheninserting andmaintainingthecatheter.• Followallcontraindications,warnings, precautionsandinstructionsforallinfusates asspecifiedbytheirmanufacturers.• Precautionsareintendedtohelpavoidcatheter damageand/orpatientinjury.• Whenutilizingtheportforarmplacement,theport shouldnotbeplacedintheaxillarycavity.

I. Prior to Placement:• Examinepackagecarefullybeforeopeningto confirmitsintegrityandthattheexpiration datehasnotpassed.Thedeviceissuppliedina sterilepackageandisnon-pyrogenic.Donot useifpackageisdamaged,openedorthe expirationdatehaspassed.STERILIZED BY ETHYLENE OXIDE.

• Donotresterilizeorreuse.Re-usemayleadto infection or illness/injury.

• Inspectkitforpresenceofallcomponents.• Checkpatient’srecords,andaskpatient, whethertheyhaveanyknownallergiesto chemicalsormaterialsthatwillbeusedduring theplacementprocedure.• Fill(prime)thedevicewithsterileheparinized salineornormalsalinesolutiontohelpavoid airembolism.Rememberthatsomepatients maybehypersensitivetoheparinorsufferfrom heparininducedthrombocytopenia(HIT)and thesepatientsmustnothavetheirportprimed withheparinizedsaline.• Whenusinganintroducerkit,verifythatthe catheterfitseasilythroughtheintroducer sheath.

II. During Placement:• Donotallowaccidentaldevicecontactwith sharpinstruments.Mechanicaldamagemay occur.Useonlysmoothedged,atraumatic clampsorforceps.• Takecarenottoperforate,tear,orfracturethe catheterduringplacement.Afterassembling cathetertoport,checkassemblyforleaksor damage.• Donotusethecatheterifthereisanyevidence ofmechanicaldamageorleaking.• Donotbendcatheteratsharpanglesduring implantation.Thiscancompromisecatheter patency.• Carefullyfollowtheconnectiontechniquegiven intheseinstructionstoensurepropercatheter connectionandtoavoidcatheterdamage.• Donotusesuturestosecurecathetertothe portstemasitcouldcollapseordamagethe catheter.• Whenusingpeel-apartintroducers: –Carefullyinserttheintroducerand cathetertoavoidinadvertentpenetrationto vitalstructuresinthethorax. – Avoidbloodvesseldamagebymaintaininga catheterordilatorasinternalsupportwhen usingapeel-apartintroducer. – Avoidsheathdamagebysimultaneously advancingthesheathanddilatorasasingle unitusingarotationalmotion.

STERILE EO

2

POSSIBLE COMPLICATIONS:

• Theuseofasubcutaneousportprovidesan importantmeansofvenousaccessforcritically illpatients.However,thepotentialexistsfor seriouscomplications,includingthefollowing: • AirEmbolism • Bleeding • BrachialPlexusInjury • CardiacArrhythmia • CardiacTamponade • CatheterorPortErosionThroughtheSkin • CatheterEmbolism • CatheterOcclusion • CatheterOcclusion,DamageorBreakage DuetoCompressionBetweentheClavicle andFirstRib • CatheterorPortRelatedSepsis • DeviceRotationorExtrusion • Endocarditis • Extravasation • FibrinSheathFormation • Hematoma • Hemothorax • Hydrothorax • IntoleranceReactiontoImplantedDevice • Inflammation,Necrosis,orScarringofSkin OverImplantArea • LacerationofVesselsorViscus • PerforationofVesselsorViscus • Pneumothorax • SpontaneousCatheterTipMalpositionor Retraction • ThoracicDuctInjury • Thromboembolism • VascularThrombosis • VesselErosion • RisksNormallyAssociatedwithLocalor GeneralAnesthesia,Surgery,and Post-OperativeRecovery

• Theseandothercomplicationsarewell documentedinmedicalliteratureandshould becarefullyconsideredbeforeplacingtheport.

IMPLANTATION INSTRUCTIONS:

• Pleasereadthroughcompleteimplantation instructionsbeforeimplantingport,noting “Contraindications,Warnings,andPrecautions” and“PossibleComplications”sectionsofthis manualbeforebeginningprocedure.

PREVENTING PINCH-OFF

• Theriskofpinch-offsyndromecanbeavoided byinsertingthecatheterviatheinternal jugularvein(IJ).Subclavianinsertionofthe cathetermedialtotheborderofthefirstrib maycausecatheterpinch-off,whichinturn resultsinocclusioncausingportsystemfailure duringpowerinjection.

• Ifyouchoosetoinsertthecatheterintothe subclavianvein,itshouldbeinsertedlateralto theborderofthefirstriboratthejunctionwith theaxillaryveinbecausesuchinsertionwill avoidcompressionofthecatheter,whichcan causedamageandevenseveranceofthe catheter.Theuseofimageguidanceupon insertionisstronglyrecommended.A radiographicconfirmationofcatheterinsertion shouldbemadetoensurethatthecatheteris notbeingpinched.

IMPLANTATION PREPARATION

1. Selectimplantationproceduretobeused. Note:Recommendedveinsforarmplacementare cephalic,basilic,ormedialcubitalbasilic. Note:Recommendedveinsforchestplacement areinternaljugularorlateralsubclavian.Refer to“Warning”sectioncoveringcatheterpinch-offif insertingthecatheterviasubclavianvein.

2. Selectthesiteforportplacement. Note: Portpocketsiteselectionshouldallowfor portplacementinananatomicareathat providesgoodportstability,doesnotinterfere withpatientmobility,doesnotcreatepressure points,hasnotpreviouslybeenirradiated,doesnot showsignsofinfection,anddoesnotinterferewith clothing.Forarmportplacement,siteshouldbe distaltothedesiredveininsertionsite.

Considertheamountofcutaneoustissueoverthe portseptum,asexcessivetissuewillmakeaccess difficult.Conversely,toothinatissuelayerover theportmayleadtotissueerosion.Atissue thicknessof0.5cmto2cmisappropriate.

3. Completepatientimplantrecord,including productreordernumberandlotnumber.

4. Performadequateanesthesia.

5. Createsterilefieldandopentray.

6. Surgicallyprepanddrapetheimplantation site.

7. ForAttachableCatheters:Flushopen-ended catheterswithheparinizedsalineandclamp thecatheterclosedseveralcentimetersfromthe proximal(port)end.Rememberthatsome patientsmaybehypersensitivetoheparinor sufferfromheparininducedthrombocytopenia (HIT)andthesepatientsmustnothavetheir portprimedwithheparinizedsaline. Note: Clampcathetersegmentsthatwill becutoffpriortoattachment.

CUT-DOWN PROCEDURE

1. PlacepatientintheTrendelenburgposition withheadturnedawayfromtheintended venipuncturesite.Forarmportplacement, positionthearminanabducted,externallyrotated position.Useacut-downincisiontoexposethe entryveinofchoice.

2. Performvesselincisionaftervesselisisolated andstabilizedtopreventbleedingandair aspiration.

3. Ifusingaveinpick,insertitstaperedend throughtheincisionandadvanceitintothe vessel.Thenslidethecathetertipintothe groovedundersideofthepick.

4. Advancethecathetertipintothevessel.

5. Withdrawtheveinpick,ifused.

6. Advancethecatheterintothevesseltothe desiredinfusionsite. Note: Cathetersshouldbepositionedwiththe cathetertipatthejunctionofthesuperiorvena cavaandtherightatrium.Verifycorrect cathetertipposition,usingfluoroscopy,or appropriatetechnology.Donotoccludeorcut catheterwhenusingsuturestosecurecatheter.

PERCUTANEOUS PROCEDURE

1. PlacepatientintheTrendelenburgposition withheadturnedawayfromtheintended venipuncturesite.

2. Locatedesiredvesselusingasmallgauge needleattachedtoasyringe.Refertothe “Warnings”sectioncoveringcatheterPinch-off, ifinsertingthecatheterviathesubclavianvein.

3. Attachintroducerneedletothesyringeand insertintovesselalongsidethesmallgauge needle.Removesmallgaugeneedle.

VEINPICK

VESSEL

CATHETER

4. Aspirategentlyastheinsertionismade.Ifthe arteryisentered,withdrawtheneedleand applymanualpressureforseveralminutes. Ifthepleuralspaceisentered,withdrawthe needleandevaluatepatientforpossible pneumothorax.

5. Whentheveinhasbeenentered,removethe syringeleavingtheneedleinplace.Placea fingeroverthehuboftheneedletominimize bloodlossandtheriskofairaspiration.The riskofairaspirationisreducedbyperforming thispartoftheprocedurewiththepatient performingtheValsalvamaneuver.

6. Ifusingamicropunctureset,inserttheflexible endoftheguidewireintotheneedle.Advance theguidewireasfarasappropriate.Verify correctpositioning,usingfluoroscopyor ultrasound.Gentlywithdrawandremovethe needle,whileholdingtheguidewireinposition. Caution:Iftheguidewiremustbewithdrawn whiletheneedleisinserted,removeboth needleandwireasaunittopreventtheneedle fromdamagingorshearingtheguidewire. Advancethesmallsheathanddilatortogether asappropriate.Withdrawthedilatorand guidewire,leavingthesmallsheathinplace. Warning:Placeathumbovertheorificeofthe sheathtominimizebloodlossandriskofair embolism.

7. Straighten“J”tipofguidewirewithtip straightenerandinserttaperedendoftip straightenerintotheneedle.

8. Removethetipstraightenerandadvancethe guidewireintothesuperiorvenacava.Advance theguidewireasfarasappropriateforthe procedure.Verifycorrectpositioning,using fluoroscopy,orappropriatetechnology.

9. Gentlywithdrawandremoveneedle. Caution:Iftheguidewiremustbewithdrawn whiletheneedleisinserted,removeboththe needleandwireasaunittohelppreventthe needlefromdamagingorshearingthe guidewire.

10. Ifusingamicropunctureset,gentlywithdraw andremovethesmallsheath,whileholdingthe standardguidewireinposition.

PEEL-APART SHEATH INTRODUCER INSTRUCTIONS

1. Advancethevesseldilatorandsheath introducerasaunitovertheexposedwire usingarotationalmotion.Advanceitintothe veinasaunit,leavingatleast2cmofsheath exposed.Note: Placementmaybefacilitatedby makingasmallincisiontoeaseintroductionof vesseldilatorandsheathintroducer. Warning: Avoidvesselperforation.

2. Releasethelockingmechanismandgently withdrawthevesseldilatorand“J”wire, leavingthesheathinplace.

3. Warning: Holdthumboverexposedopeningof sheathtopreventairaspiration.Theriskofair aspirationisreducedbyperformingthispart oftheprocedurewiththepatientperforming theValsalvamaneuver.

4. Insertcatheterintothesheath.Advancethe catheterthroughthesheathintothevesselto thedesiredinfusionsite.Cathetersshouldbe positionedwiththecathetertipatthejunction ofthesuperiorvenacavaandtherightatrium.

5. Verifycorrectcathetertippositionusing fluoroscopy,orappropriatetechnology. Note: For arm-placed port,movethepatient’s armtoseveralpositionsrelativetothebody. Usingfluoroscopy,evaluatetheeffectofthis movementonthecathetertiplocationduringeach movement.Ifappropriate,repositionthecatheter sothetipisinthedesiredlocation. Note:Exercisecareintheplacementofthe cathetertip.Movementofthepatient’sarmin whichthesystemisimplantedcancause displacementofthecathetertipawayfromthe desiredlocation.

6. Graspthetwohandlesofthepeel-apartsheath andpulloutwardandupwardatthesame time.

7. Peelthesheathawayfromthecatheter completely.Makesurethecatheterisnot dislodgedfromvessel.

CATHETER TUNNELING PROCEDURE

1. Createasubcutaneouspocketusingblunt dissection.Note: Doatrialplacementtoverify thatthepocketislargeenoughtoaccommodate theportandthattheportdoesnotliebeneaththe incision.

Attachable Catheters

• Createasubcutaneoustunnelfromthevenous sitetotheportpocketsiteusingtunneleror longforcepsperthefollowing:

a. Makeasmallincisionatthevenousentrysite.

b. Inserttipoftunnelerintothesmallincision.

c. Formtunnelbyadvancingtipoftunnelerfrom thevenousentrysitetotheportpocketsite. Caution: Avoidinadvertentpunctureofthe skinoffasciawiththetipofthetunneler.

d. Removecatheterlockfromthecatheter. Caution:Neveruseacatheterlockthat appearscrackedorotherwisedamaged.

e. Attachendofcatheterontothetunnelerbarb withatwistingmotion.Note:Barbthreads mustbecompletelycoveredbythecatheterto adequatelysecurethecatheterasitispulled throughthetunnel.Asuturemaybetied aroundthecatheterbetweenthetunnelerbody andthelargebarbtoholditmoresecurely.

f. Pullthetunnelerthroughtotheportpocketsite whilegentlyholdingthecatheter. Note: Thecathetermustnotbeforced.

9.6F Plastic Stem Silicone Version

g. Placecatheterlockbackontocatheter, ensuringtheradiopaqueringfacesproximally (towardtheendofthecatheterthatwillbe attachedtotheport).h. Cutthecathetertotheproperlengthata90˚ angle,allowingsufficientslackforbody movementandportconnection.Checkcatheter foranydamage.Ifanydamageisnoted,cut damagedsectionoffbeforeconnectingcatheter toport.

CONNECT CATHETER TO PORT

1. Flushallairfromtheportbodyusinga10ml syringewithanon-coringneedlefilledwith heparinizedsaline(100USPU/ml).Insertthe needlethroughtheseptumandinjectthefluid whilepointingthestemup.Rememberthat somepatientsmaybehypersensitivetoheparin andthesepatientsmustnothavetheirport flushedwithheparinizedsaline.

2. Cleanseallsystemcomponentswithirrigation solution.

3. Connectcathetertoport: Caution: Priortoadvancingthecatheterlock, ensurethatthecatheterisproperlypositioned. Acatheternotadvancedtotheproperregion maynotseatsecurelyandleadtodislodgment andextravasation.Thecathetermustbe straightwithnosignofkinking.Aslightpullon thecatheterissufficienttostraightenit. Advancingthecatheterlockoverakinked cathetermaydamagethecatheter.Donothold thecatheterorcatheterlockwithany instrumentsthatcouldpotentiallydamage eitherpiece(e.g.,hemostats).

a. Alignportstemwithcatheter. Note:Ifthecatheterandlockare connectedandthendisconnected,the catheterendmustbere-trimmedto ensureasecurere-connection.

b. Advancecatheteroverportstemto midwaybetweentheribsforthe9.6F Siliconeversions;;advanceall8Fplastic stemand6.6F/5FtitaniumstemTriniflex® cathetersjustoverthesecondribandall8F titaniumstemTriniflex®cathetersjustupto thesecondrib.Note: Advancingcathetertoo faralongportstemcouldleadto “mushrooming”oftubingwhenthe catheterlockisadvanced.Shouldthis occur,itisadvisabletostopadvancing thecatheterlock,pullthecatheterback alongthestemawayfromtheport,and re-assembletheconnection.

c. Advancecatheterlockstraightuntilflush withport.Note: Besuretheendcontaining theradiopaqueringisproximaltotheport. Catheterlockshouldbesufficienttosecure cathetertoport.Medcomp®doesnot recommendsuturingaroundthecatheteras doingsocouldcompress,kink,ordamage catheter.

RibsStem

Catheter

CatheterLock

Rib

RadiopaqueRing

8F Plastic Stem BiocompatiblePolycarbonate Urethane Version

RadiopaqueRingRibs

Stem

Catheter

CatheterLock

9.6F Plastic Stem Silicone Version

POSITION PORT AND CLOSE INCISION SITE

1. Placetheportinthesubcutaneouspocket awayfromtheincisionline.Thiswillreducethe riskofportmigrationandthepossibilityofit flippingover.Securetheporttotheunderlying fasciausingnon-absorbable,monofilament sutures.Leavesufficientslackinthecatheter topermitslightmovement,andverifythatthe catheterisnotkinked.

2. Aftersuturingtheportinthepocket,flushthe woundwithanappropriateantibioticsolution.

3. Conductflowstudiesonthecatheterusinga non-coringneedleand10mlsyringetoconfirm thattheflowisnotobstructed,thatnoleak exists,andthatthecatheteriscorrectly positioned.

4. Aspiratetoconfirmtheabilitytodrawblood.

5. Flushandheparinlocktheportsystemas describedunder“HeparinLockProcedure”. Rememberthatsomepatientsmaybe hypersensitivetoheparinorsufferfrom heparininducedthromboctopenia(HIT)and cautionshouldbeusedwhenusingheparinized salinetolocktheport.

6. Aftertherapycompletion,flushportper institutionalprotocol.

7. Closetheincisionsite,sothattheportdoesnot liebeneaththeincision.

8. Applydressingaccordingtohospitalpractice.

HEPARIN LOCK PROCEDURE

• Tohelppreventclotformationandcatheter blockage,implantedportswithopen-ended cathetersshouldbefilledwithsterile heparinizedsalineaftereachuse.Iftheport remainsunusedforlongperiodsoftime,the heparinlockshouldbechangedatleastonce everyfourweeks.Rememberthatsomepatients maybehypersensitivetoheparinandthese patientsmustnothavetheirportlockedwith heparinizedsaline.

Determining Port Volumes

• ForPowerInjectableImplantableInfusionPort devices,youwillneedtodeterminethelength ofcatheterusedforeachindividualpatient.

• Forsystemprimingvolume,multiplythecatheter lengthincmby0.02ml/cmthenaddthepriming volumefortheparticularportconfigurationas follows: MiniProfileCTPort:0.40ml LowProfileCTPorts:0.39ml Mid-SizeCTPort:0.56ml StandardCTPort:0.64ml

6.6F/5F Titanium Stem BiocompatiblePolycarbonate Urethane Version

RadiopaqueRing

StemRibs

Catheter

CatheterLock

RibRadiopaqueRing

StemRibs

Catheter

CatheterLock

8F Titanium Stem BiocompatiblePolycarbonate Urethane Version

Equipment

• Non-coringneedle• 10mlsyringefilledwithsterilesaline• 10mlsyringefilledwith5mlheparinized saline(100U/ml).

Note: Otherconcentrationsofheparinizedsaline(10to1000U/ml)havebeenfoundtobeeffective.Determinationofproperconcentrationandvolumeshouldbebasedonpatient’smedicalcondition,laboratorytests,andpriorexperience.

Procedure:

1. Explainproceduretopatientandprepare injectionsite.

2. Attacha10mlsyringefilledwithsterilenormal salinetoneedle.

3. Asepticallylocateandaccessport.

4. Flushthesystem,thenrepeatwith5mlof100 U/mlheparinizedsaline.

5. Aftertherapycompletion,flushportper institutionalprotocol.Alcoholshouldnotbe usedtosoakordeclotpolyurethanecatheters becausealcoholisknowntodegrade thepolyurethanecathetersovertimewith repeatedandprolongedexposure.

POWER INJECTION PROCEDURE:

Before proceeding follow institutional protocol to verify correct catheter tip position via radiographic image prior to power injection.

1. Accesstheportwithanappropriatenon-coring needle.Makecertainthatneedletipisinserted fullywithintheport. Warning: The Power Injectable Implantable Infusion Port is only power injectable when accessed with a power injectable needle. 2. Attachasyringefilledwithsterilenormal saline.

3. Instructthepatienttoassumethepositionthey willbeinduringthepowerinjectionprocedure, beforecheckingforpatency.Ifpossible,the patientshouldreceivepowerinjectionwithhis orherarmverticallyabovetheshoulderwith thepalmofthehandonthefaceofthe gantryduringinjection.Thisallowsfor uninterruptedpassageofinjectedcontrast throughtheaxillaryandsubclavianveinsat thethoracicoutlet.

Recommended Flushing Volumes:

FLUSHING VOLUMES

PROCEDURES VOLUME (100 U/ml)

Whenportnotinuse 5mlheparinizedsalineevery4weeks

AftereachinfusionofmedicationorTPN

10mlsterilenormalsalinethen5mlheparinizedsaline

Afterbloodwithdrawal 20mlsterilenormalsalinethen5mlheparinizedsaline

Afterpowerinjectionofcontrastmedia

10mlsterilenormalsalinethen5mlheparinizedsaline

• Forfuturereferenceitwillbehelpfultorecord thisinformationonthepatient’schartand/or patientIDcard.

4. Aspirateforadequatebloodreturnand vigorouslyflushtheportwithatleast10mlof sterilenormalsaline. Warning: Failuretoensurepatencyofthe catheterpriortopowerinjectionstudiesmay resultinportsystemfailure.

5. Detachsyringe.

6. Warmcontrastmediatobodytemperature.

7. Attachthepowerinjectiondevicetotheneedle ensuringconnectionissecure.Checkindicated flowrateandconfirmCTsettings.

Non-CoringNeedleGaugeSize 19Ga. 20Ga. 22Ga.

MaximumRecommendedFlowRateSetting

5ml/s 5ml/s 2ml/s

8. Instructthepatienttocommunicate immediatelyanypainorchangeinfeeling duringtheinjection.

9. Injectwarmedcontrast,takingcarenotto exceedtheflowratelimits. Warning:Iflocalpain,swellingorsignsof extravasationarenoted,theinjectionshould bestoppedimmediately. Warning:Exceedingthemaximumflowrate mayresultinportsystemfailureand/or cathetertipdisplacement.

10. Disconnectthepowerinjectiondevice.

11. Flushtheportwith10mlofsterilenormal saline.

12. Performheparinlockprocedure.Remember thatsomepatientsmaybehypersensitiveto heparinorsufferheparininduced thrombocytopenia(HIT).Thesepatientsmust nothavetheirportprimedwithheparinized saline.

13. Aftertherapycompletion,flushportper institutionalprotocol.Closeclampwhile injectinglast0.5mlofflushsolution.

Warning: Donotexceeda300psipressurelimitsetting,orthemaximumflowratesettingshownbelow,onthepowerinjectionmachineifpowerinjectingthroughthePowerInjectableImplantableInfusionPort.

TheMedcomp®CTImplantablePortsystemtestingincludedatleast40powerinjectioncycleswithaCTratedHuberneedlesetand11.8Centipose(cp)viscositycontrastsolution.

Port/Catheter Configuration

Average Port

Reservoir Pressureb

Average Static Burst

Pressurec

Static Burst Pressure Rangec

LowProfileMini Dignity

Port

5F 94psi 165psi 148-183psi

6.6F 66psi 173psi 160-185psi

8F 41psi 165psi 154-174psi

LowProfileDignity Port

5F 90psi 185psi 166-215psi

6.6F 65psi 178psi 164-193psi

8F 40psi 186psi 175-208psi

Mid-SizedDignity

Port

5F 92psi 185psi 163-198psi

6.6F 67psi 166psi 156-177psi

8F 37psi 188psi 159-228psi

9.6F 46psi 136psi 128-139psi

Standard Size

Pro-Fuse Port

8F 40psi 160psi 112-185psi

9.6F 44psi 137psi 121-147psi

LowProfilePro-Fuse

Port

5F 116psi 231psi 190-283psi

6.6F 68psi 154psi 148-159psi

8F 66psi 169psi 157-182psi

Indicated CT Flow Rates

Non-Coring Needle GaugeSize 19 Ga. 20 Ga. 22 Ga.

Maximum Flow Ratea 5ml/s 5ml/s 2ml/s

Note:CTinjectionpressureshouldbesetatamaximumof300psi.Flowrateslessthan5ml/sand/orlowerviscositycontrastwillgeneratelowerpressuresintheportandcatheter.aRepresentsflowcapabilityofportandcatheterassemblyforpowerinjectionofcontrastmedia.bInternalportpressureduringmaximumindicatedCTflowrateusingcontrastmediawith11.8Centipoise(cp)viscosity.cAveragestaticburstpressureandrangeistheburstpressureoftheportcatheterassembly.

REFERENCES

1. Jacobs,D.M.et.al.,“Anatomicaland MorphologicalEvaluationofPacemakerLead Compression.PACE.1993Mar;16(1):434-444.

2. Magney,J.E.et.al.,“AnatomicalMechanisms ExplainingDamagetoPacemakerLeads, DefibrillatorLeads,andFailureofCentral VenousCathetersAdjacenttothe SternoclavicularJoint”.PACE.1993Mar; 16(1):445-457.

3. Hinke,D.H.;Zandt-Stastny,D.A.;Goodman, L.R.;et.al.“Pinch-offsyndrome:Acomplication ofimplantablesubclavianvenousaccess devices”.Radiology177:353-356,1990.

4. Ingle,Rebecca;Nace,Corinne.“VenousAccess Devices:CatheterPinch-offandFracture.” 1993,BardAccessSystems,Inc.

5. Camp-Sorrell,Dawn.“AccessDevice Guidelines.:2ndEd.OncologyNursingSociety, 2004.

FURTHER READING

• SeeMedcomp®ImplantableInfusionPort PatientGuideand/orCTGuideformore details. • ContactaMedcomp®SalesRepresentativefor moreinformationaboutanyoftheseproducts.

WARRANTY

Medcomp® WARRANTS THAT THIS PRODUCT WAS MANUFACTURED ACCORDING TO APPLICABLE STANDARDS AND SPECIFICATIONS. PATIENT CONDITION, CLINICAL TREATMENT, AND PRODUCTMAINTENANCE MAY EFFECT THE PERFORMANCE OFTHIS PRODUCT. USE OF THIS PRODUCT SHOULD BE INACCORDANCE WITH THE INSTRUCTIONS PROVIDED ANDAS DIRECTED BY THE PRESCRIBING PHYSICIAN.

Becauseofcontinuingproductimprovement,prices,specifications,andmodelavailabilityaresubjecttochangewithoutnotice.Medcomp®Interventionalreservestherighttomodifyitsproductsorcontentswithoutnotice.

Triniflex® isaregisteredtrademarkofMedicalComponents,Inc.

Doesnotcontainnaturalrubberlatexcomponents

AllpackagingandcomponentsareDEHPFree

EUREPRESENTATIVEMPSMedicalProductServiceGmbHBorngasse2035619BraunfelsGermany

MRConditional-3Tesla(artifactsmaypresentimaging problemsifMRareaofinterestisonornearareawhere

deviceislocated)

Report Conclusion: MRI InformationMRConditionalTheImplantableVascularAccessPortwasdeterminedtobeMR-conditional.

Non-clinicaltestingdemonstratedthattheImplantableVascularAccessPortisMRConditional.Apatientwiththisdevicecanbescannedsafelyimmediatelyafterplacementunderthefollowingconditions:

StaticMagneticField-Staticmagneticfieldof3-Teslaorless-Maximumspatialgradientmagneticfieldof720-Gauss/cmorless

MRI-RelatedHeatingInnon-clinicaltesting,theImplantableVascularAccessPortproducedthefollowingtemperatureriseduringMRIperformedfor15-minofscanning(i.e.,perpulsesequence)inthe3-Tesla(3-Tesla/128-MHz,Excite,HDx,Software14X.M5,GeneralElectricHealthcare,Milwaukee,WI)MRsystem:

Highesttemperaturechange+1.6˚C

Therefore,theMRI-relatedheatingexperimentsfortheImplantableVascularAccessPortat3-Teslausingatransmit/receiveRFbodycoilatanMRsystemreportedwholebodyaveragedSARof2.9-W/kg(i.e.,associatedwithacalorimetrymeasuredwholebodyaveragedvalueof2.7-W/kg)indicatedthatthegreatestamountofheatingthatoccurredinassociationwiththesespecificconditionswasequaltoorlessthan+1.6˚C.

Artifact InformationMRimagequalitymaybecompromisediftheareaofinterestisintheexactsameareaorrelativelyclosetothepositionoftheImplantableVas-cularAccessPort.Themaximumartifactsize(i.e.,asseenonthegradientechopulsesequence)extendsapproximately25-mmrelativetothesizeandshapeofthisdeviceduringMRimaging(3-Tesla/128-MHz,Excite,HDx,Software14X.M5,transmit/receiveRFbodycoil,GeneralElectricHealthcare,Milwaukee,WI).Therefore,optimizationofMRimagingpa-rameterstocompensateforthepresenceofthisdevicemaybenecessary.

MR

PN40435 Rev.3/12F