1II. During Port Access:• Do not use a syringe smaller than 10 mL. Flushing occluded catheters with small syringes can create excessive pressures within the port system.• PowerPort*implantableportsareonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.• Failuretowarmcontrastmediatobodytemperaturepriortopowerinjectionmayresultinportsystemfailure.• Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.• Powerinjectormachinepressurelimitingfeaturemaynotpreventoverpressurizationofanoccludedcatheter.• Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.• PowerPort*deviceindicationforpowerinjectionofcontrastmediaimpliestheport’sabilitytowithstandtheprocedure,butitdoes
not implyappropriatenessof theprocedureforaparticularpatientnor foraparticular infusionset.Asuitablytrainedclinician isresponsibleforevaluatingthehealthstatusofapatientasitpertainstoapowerinjectionprocedureandforevaluatingthesuitabilityofanyinfusionsetusedtoaccesstheport.
• Donotexceeda300psipressure limitsettingonthepower injectionmachine,orthemaximumrecommendedflowrateonthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
• Iflocalpain,swellingorsignsofextravasationarenotedduringpowerinjection,theinjectionshouldbestoppedimmediately.
Signs of Pinch-off
Clinical:• Difficultywithbloodwithdrawal• Resistancetoinfusionoffluids• Patientpositionchangesrequiredforinfusionoffluidsor bloodwithdrawal
Radiologic:• Grade 1 or 2 distortion on chest X-ray. Pinch-off should be
evaluated for degree of severity prior to explantation. Patientsindicatinganydegreeofcatheterdistortionattheclavicle/firstribareashouldbefolloweddiligently.Therearegradesofpinch-offthatshouldberecognizedwithappropriatechestx-rayasshowninthetableatright.3,4
Precautions
• Carefullyreadandfollowallinstructionsintheseinstructionsforuse.• Federal(U.S.A.)lawrestrictsthisdevicetosalebyorontheorderofaphysician.• Onlyqualifiedhealthcarepractitionersshouldinsert,manipulateandremovethesedevices.• Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.• Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandwireasaunittopreventtheneedle
fromdamagingorshearingtheguidewire.• Useonlynon-coringneedleswiththeport.• Priortoadvancingthecatheterlock,ensurethatthecatheterisproperlypositioned.Acatheternotadvancedtotheproperregion
maynotseatsecurelyandleadtodislodgmentandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
• Followuniversalprecautionswheninsertingandmaintainingthecatheter.• Followallcontraindications,warnings,precautionsandinstructionsforallinfusatesasspecifiedbytheirmanufacturers.• Precautionsareintendedtohelpavoidcatheterdamageand/orpatientinjury.
I. Prior to Placement:• Examinepackagecarefullybeforeopeningtoconfirmitsintegrityandthattheexpirationdatehasnotpassed.Thedeviceissupplied
inadoublesterilepackageand isnon-pyrogenic.Donotuse ifpackage isdamaged,openedor theexpirationdatehaspassed.Sterilizedbyethyleneoxide.Donotresterilize.
• Inspectkitforpresenceofallcomponents.• Checkpatient’srecords,andaskpatient,whethertheyhaveanyknownallergiestochemicalsormaterialsthatwillbeusedduring
the placement procedure.• Fill(prime)thedevicewithsterilenormalsalinesolutiontohelpavoidairembolism.• Whenusinganintroducerkit,verifythatthecatheterfitseasilythroughtheintroducersheath.• Whenutilizingportforarmplacement,theportshouldnotbeplacedintheaxillarycavity.• BardAccessSystems,Inc.recommendstheuseofcomponentsprovidedinthekit.Ifadditionalitemsaretobeused,checkforproper
fitpriortoutilization.Note:Portbody,catheterandcatheterlockcannotbereplacedwithcomponentsoutsidetheprovidedkit.
II. During Placement:• Donotallowaccidentaldevicecontactwithsharpinstruments.Mechanicaldamagemayoccur.Useonlysmoothedged,atraumatic
clampsorforceps.• Takecarenottoperforate,tear,orfracturethecatheterduringplacement.Afterassemblingcathetertoport,checkassemblyforleaks
or damage. • Donotusethecatheterifthereisanyevidenceofmechanicaldamageorleaking.• Donotbendcatheteratsharpanglesduringimplantation.Thiscancompromisecatheterpatency.• Carefullyfollowtheconnectiontechniquegivenintheseinstructionstoensurepropercatheterconnectionandtoavoidcatheter
damage.• Donotusesuturestosecurecathetertotheportstemasitcouldcollapseordamagethecatheter.• Whenusingpeel-apartintroducers:
-Carefullyinserttheintroducerandcathetertoavoidinadvertentpenetrationtovitalstructuresinthethorax.-Avoidbloodvesseldamagebymaintainingacatheterordilatorasinternalsupportwhenusingapeel-apartintroducer.-Avoidsheathdamagebysimultaneouslyadvancingthesheathanddilatorasasingleunitusingarotationalmotion.
• Neveruseacatheterlockthatappearscrackedorotherwisedamaged.
Grade Severity Recommended Action
Grade 0 Nodistortion Noaction
Grade 1Distortion present without luminal narrowing
Chestx-rayshouldbetakenevery one to three months to monitorprogressionofpinch-off to grade 2 distortion. Shoulderpositioningduringchestx-raysshouldbenotedasitcancontributetochanges in distortion grades.
Grade 2Distortion present without luminal narrowing
Removalofthecathetershouldbeconsidered.
Grade 3 Catheter transec-tionorfracture Promptremovalofthecatheter.
2 3III. AfterPlacement:• EncouragepatienttokeeppatientIDcardandpresentittocliniciansaccessingtheirport.• Careshouldbetakentoavoidexcessiveforcewhenaccessinganimplantedport.
Poss ible Compl icat ions
Theuseofasubcutaneousportprovidesanimportantmeansofvenousaccessforcriticallyillpatients.However,thepotentialexistsforseriouscomplications,includingthefollowing:
Theseandothercomplicationsarewelldocumentedinmedicalliteratureandshouldbecarefullyconsideredbeforeplacingtheport.
I mplantat ion I nstruc t ions
Pleasereadthroughcompleteimplantationinstructionsbeforeimplantingport,noting“Contraindications,Warnings,andPrecautions”and“PossibleComplications”sectionsofthismanualbeforebeginningprocedure.
Prevent ingPinch-Off
Theriskofpinch-offsyndromecanbeavoidedbyinsertingthecatheterviatheinternaljugularvein(IJ). Subclavianinsertionofthecathetermedialtotheborderofthefirstribmaycausecatheterpinch-off,whichinturnresultsinocclusioncausingportsystemfailureduringpowerinjection.
Ifyouchoosetoinsertthecatheterintothesubclavianvein,itshouldbeinsertedlateraltotheborderofthefirstriboratthejunctionwith the axillary vein because such insertionwill avoid compression of the catheter,which can cause damage and even sever thecatheter.Theuseofimageguidanceuponinsertionisstronglyrecommended.Aradiographicconfirmationofcatheterinsertionshouldbemadetoensurethatthecatheterisnotbeingpinched.
I mplantat ion Preparat ion
1. Selectimplantationproceduretobeused.2. Selectthesiteforportplacement. Note: Port pocket site selection should allow for port placement in an anatomic area that provides good port stability,
does not interfere with patient mobility or daily activities, does not create pressure points, has not previously beenirradiated, does not show signs of infection, and does not interfere with clothing. Ideally choose an implantation sitein the lateral infraclavicular region for cosmesis and functionality. For arm port placement, port site should be distalto the desired vein insertion site. Patient’s arm movement should be considered when determining the length of thecatheter and the final tip location. Consider the amount of cutaneous tissue over the port septum, as excessive tissuewill make access difficult. Conversely, too thin a tissue layer over the port may lead to tissue erosion. A tissue thickness of 0.5 cm to 2 cm is appropriate.
3. Completepatientimplantrecord,includinglengthofcatheterimplanted,productreordernumberandlotnumber.4. Performadequateanesthesia.5. Createsterilefieldandopentray. Note:Thecatheterandportmaybesoakedinsterilenormalsalinepriortoplacement.6. Surgicallyprepanddrapetheimplantationsite.7a. ForAttachableCatheters:Flusheachlumenofopen-endedcatheterswithsterilenormalsaline,throughtheflushingconnectorand
clampthecatheterclosedseveralcentimetersfromthedistal(port)end. Note:Clampedcathetersegmentswillbecutoffpriortoattachment.7b. ForPre-AttachedCatheters:Useanon-coringneedletoflushtheportandcathetersystemwithsterilenormalsaline.7c. ForGroshong*catheters:Flushcatheterwithsterilenormalsalinethroughthepre-loadedstyletconnector.8. PlacepatientintheTrendelenburgpositionwithheadturnedawayfromtheintendedvenipuncturesite.Forarmportplacement,
positionthearminanabducted,externallyrotatedposition. Note:Recommendedveinsforarmplacementarecephalic,basilic,ormedialcubitalbasilic. Note:Recommendedveinsforchestplacementare internal jugularor lateralsubclavian.Refer to the "Warnings"sectioncovering
catheterpinch-offifinsertingthecatheterviathesubclavianvein.
Percutaneous Procedure
1. Locate and access vessel with introducer needle attached to a syringe. 2. Aspirate gently as the insertion ismade. If the artery is entered, withdraw the needle and applymanual pressure for several
minutes.Ifthepleuralspaceisentered,withdrawtheneedleandevaluatepatientforpossiblepneumothorax.3. Whentheveinhasbeenentered,removethesyringeleavingtheneedleinplace. Warning:Placethumboverexposedopeningofsheathorneedleorattachsyringefilledwithsterilenormalsalinesolutiontominimize
bloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• AirEmbolism• AllergicReaction• Bleeding• BrachialPlexusInjury• CardiacArrhythmia• CardiacPuncture• CardiacTamponade• CatheterorPortErosionThrough
theSkin• CatheterEmbolism• CatheterOcclusion• Catheterorport-relatedSepsis• DamageorBreakageduetoCompression
betweentheClavicleandFirstRib• DeviceRotationorExtrusion
• Endocarditis• Extravasation• FibrinSheathFormation• GuidewireFragmentEmbolism• Hematoma• Hemothorax• Hydrothorax• Infection,includingbutnotlimitedtopocket,
cathetertunnel,and/orbloodstream• Inflammation,Necrosis,orScarringof SkinOverImplantArea• IntoleranceorReactionto
Implanted Device• LacerationofVesselsorViscus• Painatoraroundportpocketsite
• PerforationofVesselsorViscus• Pneumothorax• RisksNormallyAssociatedwithLocal orGeneralAnesthesia,Surgery,and Post-OperativeRecovery• SpontaneousCatheterTipMalposition orRetraction• ThoracicDuctInjury• Thromboembolism• VascularThrombosis• VesselErosion
4 If using a micropuncture set, insert the flexible end of themicropuncture guidewire into the introducer needle. Advance the
guidewireas farasappropriate.Verifycorrectpositioning,usingfluoroscopyorappropriatetechnology.Gentlywithdrawandremove the needle, while holding themicropuncture guidewire in position. Advance the small sheath and dilator togetherasaunitoverthemicropunctureguidewire,usingaslightrotationalmotion.Withdrawthedilatorandguidewire, leavingthemicrointroducer sheath in place.
Caution:Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removebothneedleandwireasaunittopreventtheneedlefromdamagingorshearingtheguidewire.
Warning:Place thumboveropeningof sheath tominimizeblood lossandpreventairembolism.The riskofairembolism isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
4. Straighten “J” tip of standard guidewire with tip straightener and insert tapered end of tip straightener into the needle (ormicrointroducersheathifusingamicropunctureset).Note: Donotadvanceguidewireifobstructionisencountered.
5. Removethetipstraightenerandadvancetheguidewireintothesuperiorvenacava.Advancetheguidewireasfarasappropriatefortheprocedure.Verifycorrectpositioningusingfluoroscopyorappropriatetechnology.
6. Gentlywithdrawandremoveneedle(ormicrointroducersheathifusingmicropunctureset). Caution: If theguidewiremustbewithdrawnwhile theneedle is inserted, removeboth theneedleandwireasaunit tohelp
preventtheneedlefromdamagingorshearingtheguidewire.
Peel -Apar t Sheath Introducer Instruct ions
1. Advance the vessel dilator and sheath introducer as a unit over the exposed wire using a rotational motion. Advance it into the vein asaunit,leavingatleast2cmofsheathexposed.
Note:Placementmaybefacilitatedbymakingasmallincisiontoeaseintroductionofvesseldilatorandsheathintroducer. Warning:Avoidvesselperforation.2. Releasethelockingmechanismandgentlywithdrawthevesseldilatorand“J”wire,leavingthesheathinplace. Warning:Placethumboverexposedopeningofsheathtominimizebloodlossandpreventairembolism.Theriskofairembolism
isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
3. Insertcatheter into thesheath.Advance thecatheter through thesheath into thevessel to thedesired infusionsite.Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacavaandtherightatrium.
4. Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.5. Graspthetwohandlesofthepeel-apartsheathandpulloutwardandupwardatthesametime.Peelthesheathawayfromthe
cathetercompletely.Makesurethecatheterisnotdislodgedfromvessel.
Cut-Down Procedure
1. Useacut-downincisiontoexposetheentryveinofchoice.2. Perform vessel incision after vessel is isolated and stabilized to prevent
bleedingandairembolism.3. Ifusingaveinpick,insertitstaperedendthroughtheincisionandadvance
itintothevessel.Thenslidethecathetertipintothegroovedundersideofthepick.
4. Advancethecathetertipintothevessel.5. Withdrawtheveinpick,ifused.6. Advancethecatheterintothevesseltothedesiredinfusionsite. Note:Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacava andtherightatruim.Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.
Catheter Tunnel ingProcedure
1. Createasubcutaneouspocketusingbluntdissection. Note:Doa trial placement to verify that thepocket is largeenough to accommodate theport and that theportdoesnot lie
beneaththeincision.
Attachable Catheters
Createasubcutaneoustunnelfromthevenoussitetotheportpocketsiteusingtunnelerorlongforcepsperthefollowing:a. Makeasmallincisionatthevenousentrysite.b. Inserttipoftunnelerintothesmallincision.c. Formtunnelbyadvancingtipoftunnelerfromthevenousentrysitetotheportpocketsite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.
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Catheter Vein pick
Vessel
5d. Removecatheterlockfromthecatheter.ForimplantedportswithGroshong*catheters,removethecatheterlockand stiffenerstyletfromthecatheterpriortocuttingcathetertoappropriatelength. Warning: Donotcutstiffeningstylet.Withdrawstiffeningstyletfromcatheterpriortocutting. Caution:Neveruseacatheterlockthatappearscrackedorotherwisedamaged.e. Attachendofcatheterontothetunnelerbarbwithatwistingmotion. Note:Barbthreadsmustbecompletelycoveredbythecathetertoadequatelysecurethecatheterasitispulledthroughthe
tunnel.Asuturemaybetiedaroundthecatheterbetweenthetunnelerbodyandthelargebarbtoholditmoresecurely.f. Pullthetunnelerthroughtotheportpocketsitewhilegentlyholdingthecatheter. Note:Thecathetermustnotbeforced.g. Cutoffendofthecatheterattachedtotunneler.
Pre-Attached Catheters
Createsubcutaneoustunnelfromtheportpocketsitetothevenousentrancesiteperthefollowing:a. Formtunnelbyadvancingthetipofthetunnelerfromtheportpocketsitetothevenousentrysite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.b. Connectthecathetertipintotheendofthetunneler.c. Pull the tunneler through to the venous entry site while gently holding the catheter. Note: Thecathetermustnotbeforced.d. Cutoffendofthecatheterattachedtotunneler.e. Estimate thecatheter length required for the tipplacementat the junctionof the superiorvenacavaand rightatriumby
placing the catheter on the chest along the venous path to the right atrium. Cut catheter to length at a 90˚ angle.
Connect Catheter ToPor t For Attachable Catheters
1. Flushallairfromeachlumenoftheportbodyusinga10mLsyringewithanon-coringneedlefilledwithsterilenormalsaline.Inserttheneedlethroughtheseptumandinjectthefluidwhilepointingthestemup.
2. Cleanse all system components with irrigation solution. Caution: Prior toadvancing thecatheter lock,ensure that thecatheter isproperlypositioned.Acatheternotadvanced to the
properregionmaynotseatsecurelyandleadtodislodgementandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
3. Connect catheter to port:a. Placecatheterlockbackontocatheter,ensuringtheblackradiopaqueringonthecatheterlockfacesawayfromtheportbody.b. Cutthecathetertotheproperlengthata90˚angle,allowingsufficientslackforbodymovementandportconnection.Check
catheterforanydamage.Ifanydamageisnoted,cutdamagedsectionoffbeforeconnectingcathetertoport.Note: Ensurethatnoguidewiresorstiffeningwiresremaininthecatheterlumenpriortocuttingandadjustingcathetertodesired length.
c. Forsinglelumenports,alignportstemwithcatheter.Whenplacingduallumenports,aligntheportstemwithbothlumens. Note:Ifthecatheterandcatheterlockareconnectedandthendisconnected,thecatheterendmustbere-trimmedtoensure
a secure re-connection. Note:Whenusingthecatheterlock,besuretheendcontainingacoloredradiopaqueringfacesawayfromtheport.Thecatheterlockshouldbesufficienttosecurecathetertoport.Note:Sterilegauzemaybeusedtofacilitatestem to catheter connection.
d. For single lumen ports: Advance catheter over port stem to midway point. Note: Advancingcatheter too far alongportstemcould leadto"mushrooming"of tubingwhenthecatheter lock isadvanced.Shouldthisoccur, it isadvisabletostopadvancingthecatheterlock,pullthecatheterbackalongthestemawayfromtheport,trimendofcatheterandre-assemblethe connection.
e. For dual lumen ports:Advancecathetercompletelyonstempriortoadvancingcatheterlock.Warning: Failure to completely advancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Warning:Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter.
Pos i t ionPor t AndClose Incis ionS i te
1. Place the port in the subcutaneous pocket away from the incision line. Secure the port to the underlying fascia using non-absorbable,monofilamentsutures.Leavesufficientslackinthecathetertopermitslightmovement,andverifythatthecatheterisnotkinked.Thiswillreducetheriskofportmigrationandthepossibilityofitflippingover.
Note:Whensuturingaportwithasiliconeportbody,placesuturethroughatleast2mmofsilicone.2. Aftersuturingtheportinthepocket,flushthewoundwithanappropriateantibioticsolution,perinstitutionalprotocol.
Stem
b. c.a. Catheter
Catheter LockStem Radiopaque Ring
ShoulderAdvance to midway point
Single Lumen PowerPor t* Device:
Stem
Shoulderb. c.a. Catheter
Catheter Lock
Warning: Advance catheter completelyon stem prior to advancing catheter lock
Advance all the way
Stem Radiopaque Ring
D ual Lumen PowerPor t* Device:
Descr ipt ion
ThePowerPort* implantableport is an implantableaccessdevicedesigned toprovide repeatedaccess to thevascular system.Portaccessisperformedbypercutaneousneedleinsertionusinganon-coringneedle.PowerinjectionisperformedusingaPowerLoc*BrandSafety InfusionSet**only.ThePowerPort*deviceconsistsof twoprimarycomponents:an injectionportwitha self-sealingsiliconeseptumandaradiopaquecatheter.SinglelumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopoftheseptumwhichincludesthreepalpationbumpsarrangedinatriangleandbypalpatingthesidesoftheport,whichisalsotriangular.DuallumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopofeachseptum;eachseptumfeaturesthreepalpationbumpsarrangedinatriangle.Allmaterialsarebiocompatible,canbeusedwithvirtuallyallinjectablesolutionsintendedformedicinaluse, includingthepower injectionofcontrastmedia. For implantableportswithGroshong*catheters, theGroshong*cathetervalvehelpsprovidesecurityagainstbloodrefluxandairembolismintotheport/cathetersystem.TheGroshong*cathetermaybeflushedwithnormalsaline,anditdoesnotrequireheparintomaintainpatency.
Indicat ions For Use
ThePowerPort*implantableportisindicatedforpatienttherapiesrequiringrepeatedaccesstothevascularsystem.Theportsystemcanbeusedforinfusionofmedications,I.V.fluids,parenteralnutritionsolutions,bloodproducts,andforthewithdrawalofbloodsamples.
WhenusedwithaPowerLoc*BrandSafetyInfusionSet**,thePowerPort*deviceisindicatedforpowerinjectionofcontrastmedia.Forpowerinjectionofcontrastmedia,themaximumrecommendedinfusionrateis5mL/s.
Contra indicat ions, Warnings, andPrecaut ions
Contraindications
Thisdeviceiscontraindicatedfor: • Catheterinsertioninthesubclavianveinmedialtotheborderofthefirstrib,anareawhichisassociatedwithhigherratesofpinch-
off.1,2Portmaybeplacedinlateralsubclavianveinbasedonevaluationbyaqualifiedpractitioner.• Whenthepresenceofdevice-relatedinfection,bacteremia,orsepticemiaisknownorsuspected.• Whenthepatient’sbodysizeisinsufficientforthesizeoftheimplanteddevice.• Whenthepatientisknownorissuspectedtobeallergictomaterialscontainedinthedevice.• Ifseverechronicobstructivelungdiseaseexists.• Iftheprospectiveinsertionsitehasbeenpreviouslyirradiated.• Iftheprospectiveplacementsitehaspreviouslysufferedepisodesofvenousthrombosisorvascularsurgicalprocedures.• Iflocaltissuefactorswillpreventproperdevicestabilizationand/oraccess.
Warnings
I. During Placement:• Intended for Single Use. Do not reuse. Reuse and/or repackagingmay create risk of patient or user infection, compromise the
structuralintegrityand/oressentialmaterialanddesigncharacteristicsofthedevice,whichmayleadtodevicefailureand/orleadtoinjury,illnessordeathofthepatient.
• Alcohol should not be used to soak or declot a polyurethane catheter because alcohol is known to degrade the polyurethanecatheter over time with repeated and prolonged exposure.
• After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice andapplicablelocal,stateandfederallawsandregulations.
• Place thumb over exposed opening of sheath or needle or attach syringe filledwith sterile normal saline solution tominimizebloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter,includingcatheterfragmentingand/orfracturing.
• Donotmanipulateapre-assembledorpre-connectedcatheter/portconnection,asthecathetercouldbecomedisconnectedfromtheport,orsystemdamagecouldoccur.
• Donotattempttomeasurethepatient’sbloodpressureonthearminwhichaperipheralsystemislocated,sincecatheterocclusionor other damage to the catheter could occur.
• Avoidvesselperforation.• Donotpowerinjectthroughaportsystemthatexhibitssignsofclavicle-firstribcompressionorpinch-offasitmayresultinport
systemfailure.• ForimplantableportswithGroshong*catheters,donotcutstylet.Withdrawstiffeningstyletfromcatheterpriortocutting.• Failuretocompletelyadvancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Examples of Radiopaque Identifiers
PowerPort* Implantable Port Features
PowerPort* Device Compatible Callout Tag
3 Palpation Bumps Arranged in a Triangle
PowerLoc* Brand Safety Infusion Set**
Triangular Shape
RadiopaqueidentifiersforPowerPort*devicesaidinidentificationasaBardpowerinjectableport.
*
*
*
*
63. Conductflowstudiesoneachlumenofthecatheterusinganon-coringneedleand10mLsyringetoconfirmthatthe flowisnotobstructed,thatnoleakexists,andthatthecatheteriscorrectlypositioned.4. Aspiratetoconfirmtheabilitytodrawblood.5. Flushandlockeachlumenoftheportsystemasdescribedunderheparinlockprocedureforopen-endedcathetersorsalinelock
proceduresforimplantableportswithGroshong*catheters. Closeclampwhileinjectinglast0.5mLofflushsolution. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.6. Closetheincisionsite,sothattheportdoesnotliebeneaththeincision.7. Apply dressing according to hospital practice.
Power In ject ionProcedure
1. Access the PowerPort* device with a PowerLoc* Brand Safety Infusion Set**. Make certain that the needle is longenough to be inserted fullywithin theport and that theneedle tiphasmade contactwith thebottomof theport reservoir. Warning: ThePowerPort*deviceisonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.
Note: Followinstitutionalprotocoltoverifycorrectcathetertippositionpriortopowerinjection.2. Attachasyringefilledwithsterilenormalsaline.3. Instructthepatienttoassumethepositiontheywillbeinduringthepowerinjectionprocedure,beforecheckingforpatency.If
possible,thepatientshouldreceivepowerinjectionwithhisorherarmverticallyabovetheshoulderwiththepalmofthehandon the faceof thegantryduring injection.This allows for uninterruptedpassageof injected contrast through the axillary andsubclavianveinsatthethoracicoutlet.
4. Aspirateforadequatebloodreturnandvigorouslyflushtheportwithat least10mLofsterilenormalsaline. Warning: Failure toensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.5. Detach syringe.6. Warmcontrastmediatobodytemperature.7. AttachthepowerinjectiondevicetothePowerLoc*BrandSafetyInfusionSet**ensuringconnectionissecure.Checkindicatedflow
rateofsafetyinfusionsetandconfirmpowerinjectorsettings. Warning: Donotexceeda300psipressurelimitsettingonthepowerinjectionmachine,orthemaximumrecommendedflowrate
onthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
8. Instructthepatienttocommunicateimmediatelyanypainorchangeinfeelingduringtheinjection.9. Injectcontrastmediawarmedtobodytemperature,takingcarenottoexceedtheflowratelimits. Warning:Iflocalpain,swellingorsignsofextravasationarenoted,theinjectionshouldbestoppedimmediately. Warning:Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.10. Disconnectthepowerinjectiondevice.11. Aftertherapycompletion,flusheachlumenoftheportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflush
solution.12. Perform heparin lock procedure or saline lock procedures for implanted ports with Groshong* catheters. For dual lumen
PowerPort*devices,flusheachlumenseparatelyandperformlockingproceduresoneachseptum. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.13. ToremovePowerLoc*BrandSafetyInfusionSet**fromtheport,activatesafetymechanismwhilewithdrawingneedleuntilyou
hear or feela "click"atwhichtimetheneedleshouldbecapturedwithinthesafetymechanismof thePowerLoc*BrandSafety
InfusionSet**.
DeterminingPor t SystemVolumes for Por t LockProcedures
Forportsystemvolumesandlockingprocedures,pleaserefertothepackaginginsert.
PowerLoc* Brand Safety Infusion Set** Gauge Size 19 Ga. 20 Ga. 22 Ga.
PowerLoc* Brand Safety Infusion Set** Gauge Color Cream Yellow Black
Maximum Recommended Flow Rate Setting 5mL/s 5mL/s 2mL/s
1II. During Port Access:• Do not use a syringe smaller than 10 mL. Flushing occluded catheters with small syringes can create excessive pressures within the port system.• PowerPort*implantableportsareonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.• Failuretowarmcontrastmediatobodytemperaturepriortopowerinjectionmayresultinportsystemfailure.• Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.• Powerinjectormachinepressurelimitingfeaturemaynotpreventoverpressurizationofanoccludedcatheter.• Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.• PowerPort*deviceindicationforpowerinjectionofcontrastmediaimpliestheport’sabilitytowithstandtheprocedure,butitdoes
not implyappropriatenessof theprocedureforaparticularpatientnor foraparticular infusionset.Asuitablytrainedclinician isresponsibleforevaluatingthehealthstatusofapatientasitpertainstoapowerinjectionprocedureandforevaluatingthesuitabilityofanyinfusionsetusedtoaccesstheport.
• Donotexceeda300psipressure limitsettingonthepower injectionmachine,orthemaximumrecommendedflowrateonthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
• Iflocalpain,swellingorsignsofextravasationarenotedduringpowerinjection,theinjectionshouldbestoppedimmediately.
Signs of Pinch-off
Clinical:• Difficultywithbloodwithdrawal• Resistancetoinfusionoffluids• Patientpositionchangesrequiredforinfusionoffluidsor bloodwithdrawal
Radiologic:• Grade 1 or 2 distortion on chest X-ray. Pinch-off should be
evaluated for degree of severity prior to explantation. Patientsindicatinganydegreeofcatheterdistortionattheclavicle/firstribareashouldbefolloweddiligently.Therearegradesofpinch-offthatshouldberecognizedwithappropriatechestx-rayasshowninthetableatright.3,4
Precautions
• Carefullyreadandfollowallinstructionsintheseinstructionsforuse.• Federal(U.S.A.)lawrestrictsthisdevicetosalebyorontheorderofaphysician.• Onlyqualifiedhealthcarepractitionersshouldinsert,manipulateandremovethesedevices.• Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.• Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandwireasaunittopreventtheneedle
fromdamagingorshearingtheguidewire.• Useonlynon-coringneedleswiththeport.• Priortoadvancingthecatheterlock,ensurethatthecatheterisproperlypositioned.Acatheternotadvancedtotheproperregion
maynotseatsecurelyandleadtodislodgmentandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
• Followuniversalprecautionswheninsertingandmaintainingthecatheter.• Followallcontraindications,warnings,precautionsandinstructionsforallinfusatesasspecifiedbytheirmanufacturers.• Precautionsareintendedtohelpavoidcatheterdamageand/orpatientinjury.
I. Prior to Placement:• Examinepackagecarefullybeforeopeningtoconfirmitsintegrityandthattheexpirationdatehasnotpassed.Thedeviceissupplied
inadoublesterilepackageand isnon-pyrogenic.Donotuse ifpackage isdamaged,openedor theexpirationdatehaspassed.Sterilizedbyethyleneoxide.Donotresterilize.
• Inspectkitforpresenceofallcomponents.• Checkpatient’srecords,andaskpatient,whethertheyhaveanyknownallergiestochemicalsormaterialsthatwillbeusedduring
the placement procedure.• Fill(prime)thedevicewithsterilenormalsalinesolutiontohelpavoidairembolism.• Whenusinganintroducerkit,verifythatthecatheterfitseasilythroughtheintroducersheath.• Whenutilizingportforarmplacement,theportshouldnotbeplacedintheaxillarycavity.• BardAccessSystems,Inc.recommendstheuseofcomponentsprovidedinthekit.Ifadditionalitemsaretobeused,checkforproper
fitpriortoutilization.Note:Portbody,catheterandcatheterlockcannotbereplacedwithcomponentsoutsidetheprovidedkit.
II. During Placement:• Donotallowaccidentaldevicecontactwithsharpinstruments.Mechanicaldamagemayoccur.Useonlysmoothedged,atraumatic
clampsorforceps.• Takecarenottoperforate,tear,orfracturethecatheterduringplacement.Afterassemblingcathetertoport,checkassemblyforleaks
or damage. • Donotusethecatheterifthereisanyevidenceofmechanicaldamageorleaking.• Donotbendcatheteratsharpanglesduringimplantation.Thiscancompromisecatheterpatency.• Carefullyfollowtheconnectiontechniquegivenintheseinstructionstoensurepropercatheterconnectionandtoavoidcatheter
damage.• Donotusesuturestosecurecathetertotheportstemasitcouldcollapseordamagethecatheter.• Whenusingpeel-apartintroducers:
-Carefullyinserttheintroducerandcathetertoavoidinadvertentpenetrationtovitalstructuresinthethorax.-Avoidbloodvesseldamagebymaintainingacatheterordilatorasinternalsupportwhenusingapeel-apartintroducer.-Avoidsheathdamagebysimultaneouslyadvancingthesheathanddilatorasasingleunitusingarotationalmotion.
• Neveruseacatheterlockthatappearscrackedorotherwisedamaged.
Grade Severity Recommended Action
Grade 0 Nodistortion Noaction
Grade 1Distortion present without luminal narrowing
Chestx-rayshouldbetakenevery one to three months to monitorprogressionofpinch-off to grade 2 distortion. Shoulderpositioningduringchestx-raysshouldbenotedasitcancontributetochanges in distortion grades.
Grade 2Distortion present without luminal narrowing
Removalofthecathetershouldbeconsidered.
Grade 3 Catheter transec-tionorfracture Promptremovalofthecatheter.
2 3III. AfterPlacement:• EncouragepatienttokeeppatientIDcardandpresentittocliniciansaccessingtheirport.• Careshouldbetakentoavoidexcessiveforcewhenaccessinganimplantedport.
Poss ible Compl icat ions
Theuseofasubcutaneousportprovidesanimportantmeansofvenousaccessforcriticallyillpatients.However,thepotentialexistsforseriouscomplications,includingthefollowing:
Theseandothercomplicationsarewelldocumentedinmedicalliteratureandshouldbecarefullyconsideredbeforeplacingtheport.
I mplantat ion I nstruc t ions
Pleasereadthroughcompleteimplantationinstructionsbeforeimplantingport,noting“Contraindications,Warnings,andPrecautions”and“PossibleComplications”sectionsofthismanualbeforebeginningprocedure.
Prevent ingPinch-Off
Theriskofpinch-offsyndromecanbeavoidedbyinsertingthecatheterviatheinternaljugularvein(IJ). Subclavianinsertionofthecathetermedialtotheborderofthefirstribmaycausecatheterpinch-off,whichinturnresultsinocclusioncausingportsystemfailureduringpowerinjection.
Ifyouchoosetoinsertthecatheterintothesubclavianvein,itshouldbeinsertedlateraltotheborderofthefirstriboratthejunctionwith the axillary vein because such insertionwill avoid compression of the catheter,which can cause damage and even sever thecatheter.Theuseofimageguidanceuponinsertionisstronglyrecommended.Aradiographicconfirmationofcatheterinsertionshouldbemadetoensurethatthecatheterisnotbeingpinched.
I mplantat ion Preparat ion
1. Selectimplantationproceduretobeused.2. Selectthesiteforportplacement. Note: Port pocket site selection should allow for port placement in an anatomic area that provides good port stability,
does not interfere with patient mobility or daily activities, does not create pressure points, has not previously beenirradiated, does not show signs of infection, and does not interfere with clothing. Ideally choose an implantation sitein the lateral infraclavicular region for cosmesis and functionality. For arm port placement, port site should be distalto the desired vein insertion site. Patient’s arm movement should be considered when determining the length of thecatheter and the final tip location. Consider the amount of cutaneous tissue over the port septum, as excessive tissuewill make access difficult. Conversely, too thin a tissue layer over the port may lead to tissue erosion. A tissue thickness of 0.5 cm to 2 cm is appropriate.
3. Completepatientimplantrecord,includinglengthofcatheterimplanted,productreordernumberandlotnumber.4. Performadequateanesthesia.5. Createsterilefieldandopentray. Note:Thecatheterandportmaybesoakedinsterilenormalsalinepriortoplacement.6. Surgicallyprepanddrapetheimplantationsite.7a. ForAttachableCatheters:Flusheachlumenofopen-endedcatheterswithsterilenormalsaline,throughtheflushingconnectorand
clampthecatheterclosedseveralcentimetersfromthedistal(port)end. Note:Clampedcathetersegmentswillbecutoffpriortoattachment.7b. ForPre-AttachedCatheters:Useanon-coringneedletoflushtheportandcathetersystemwithsterilenormalsaline.7c. ForGroshong*catheters:Flushcatheterwithsterilenormalsalinethroughthepre-loadedstyletconnector.8. PlacepatientintheTrendelenburgpositionwithheadturnedawayfromtheintendedvenipuncturesite.Forarmportplacement,
positionthearminanabducted,externallyrotatedposition. Note:Recommendedveinsforarmplacementarecephalic,basilic,ormedialcubitalbasilic. Note:Recommendedveinsforchestplacementare internal jugularor lateralsubclavian.Refer to the "Warnings"sectioncovering
catheterpinch-offifinsertingthecatheterviathesubclavianvein.
Percutaneous Procedure
1. Locate and access vessel with introducer needle attached to a syringe. 2. Aspirate gently as the insertion ismade. If the artery is entered, withdraw the needle and applymanual pressure for several
minutes.Ifthepleuralspaceisentered,withdrawtheneedleandevaluatepatientforpossiblepneumothorax.3. Whentheveinhasbeenentered,removethesyringeleavingtheneedleinplace. Warning:Placethumboverexposedopeningofsheathorneedleorattachsyringefilledwithsterilenormalsalinesolutiontominimize
bloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• AirEmbolism• AllergicReaction• Bleeding• BrachialPlexusInjury• CardiacArrhythmia• CardiacPuncture• CardiacTamponade• CatheterorPortErosionThrough
theSkin• CatheterEmbolism• CatheterOcclusion• Catheterorport-relatedSepsis• DamageorBreakageduetoCompression
betweentheClavicleandFirstRib• DeviceRotationorExtrusion
• Endocarditis• Extravasation• FibrinSheathFormation• GuidewireFragmentEmbolism• Hematoma• Hemothorax• Hydrothorax• Infection,includingbutnotlimitedtopocket,
cathetertunnel,and/orbloodstream• Inflammation,Necrosis,orScarringof SkinOverImplantArea• IntoleranceorReactionto
Implanted Device• LacerationofVesselsorViscus• Painatoraroundportpocketsite
• PerforationofVesselsorViscus• Pneumothorax• RisksNormallyAssociatedwithLocal orGeneralAnesthesia,Surgery,and Post-OperativeRecovery• SpontaneousCatheterTipMalposition orRetraction• ThoracicDuctInjury• Thromboembolism• VascularThrombosis• VesselErosion
4 If using a micropuncture set, insert the flexible end of themicropuncture guidewire into the introducer needle. Advance the
guidewireas farasappropriate.Verifycorrectpositioning,usingfluoroscopyorappropriatetechnology.Gentlywithdrawandremove the needle, while holding themicropuncture guidewire in position. Advance the small sheath and dilator togetherasaunitoverthemicropunctureguidewire,usingaslightrotationalmotion.Withdrawthedilatorandguidewire, leavingthemicrointroducer sheath in place.
Caution:Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removebothneedleandwireasaunittopreventtheneedlefromdamagingorshearingtheguidewire.
Warning:Place thumboveropeningof sheath tominimizeblood lossandpreventairembolism.The riskofairembolism isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
4. Straighten “J” tip of standard guidewire with tip straightener and insert tapered end of tip straightener into the needle (ormicrointroducersheathifusingamicropunctureset).Note: Donotadvanceguidewireifobstructionisencountered.
5. Removethetipstraightenerandadvancetheguidewireintothesuperiorvenacava.Advancetheguidewireasfarasappropriatefortheprocedure.Verifycorrectpositioningusingfluoroscopyorappropriatetechnology.
6. Gentlywithdrawandremoveneedle(ormicrointroducersheathifusingmicropunctureset). Caution: If theguidewiremustbewithdrawnwhile theneedle is inserted, removeboth theneedleandwireasaunit tohelp
preventtheneedlefromdamagingorshearingtheguidewire.
Peel -Apar t Sheath Introducer Instruct ions
1. Advance the vessel dilator and sheath introducer as a unit over the exposed wire using a rotational motion. Advance it into the vein asaunit,leavingatleast2cmofsheathexposed.
Note:Placementmaybefacilitatedbymakingasmallincisiontoeaseintroductionofvesseldilatorandsheathintroducer. Warning:Avoidvesselperforation.2. Releasethelockingmechanismandgentlywithdrawthevesseldilatorand“J”wire,leavingthesheathinplace. Warning:Placethumboverexposedopeningofsheathtominimizebloodlossandpreventairembolism.Theriskofairembolism
isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
3. Insertcatheter into thesheath.Advance thecatheter through thesheath into thevessel to thedesired infusionsite.Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacavaandtherightatrium.
4. Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.5. Graspthetwohandlesofthepeel-apartsheathandpulloutwardandupwardatthesametime.Peelthesheathawayfromthe
cathetercompletely.Makesurethecatheterisnotdislodgedfromvessel.
Cut-Down Procedure
1. Useacut-downincisiontoexposetheentryveinofchoice.2. Perform vessel incision after vessel is isolated and stabilized to prevent
bleedingandairembolism.3. Ifusingaveinpick,insertitstaperedendthroughtheincisionandadvance
itintothevessel.Thenslidethecathetertipintothegroovedundersideofthepick.
4. Advancethecathetertipintothevessel.5. Withdrawtheveinpick,ifused.6. Advancethecatheterintothevesseltothedesiredinfusionsite. Note:Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacava andtherightatruim.Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.
Catheter Tunnel ingProcedure
1. Createasubcutaneouspocketusingbluntdissection. Note:Doa trial placement to verify that thepocket is largeenough to accommodate theport and that theportdoesnot lie
beneaththeincision.
Attachable Catheters
Createasubcutaneoustunnelfromthevenoussitetotheportpocketsiteusingtunnelerorlongforcepsperthefollowing:a. Makeasmallincisionatthevenousentrysite.b. Inserttipoftunnelerintothesmallincision.c. Formtunnelbyadvancingtipoftunnelerfromthevenousentrysitetotheportpocketsite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.
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2b1 2a 3 5
Catheter Vein pick
Vessel
5d. Removecatheterlockfromthecatheter.ForimplantedportswithGroshong*catheters,removethecatheterlockand stiffenerstyletfromthecatheterpriortocuttingcathetertoappropriatelength. Warning: Donotcutstiffeningstylet.Withdrawstiffeningstyletfromcatheterpriortocutting. Caution:Neveruseacatheterlockthatappearscrackedorotherwisedamaged.e. Attachendofcatheterontothetunnelerbarbwithatwistingmotion. Note:Barbthreadsmustbecompletelycoveredbythecathetertoadequatelysecurethecatheterasitispulledthroughthe
tunnel.Asuturemaybetiedaroundthecatheterbetweenthetunnelerbodyandthelargebarbtoholditmoresecurely.f. Pullthetunnelerthroughtotheportpocketsitewhilegentlyholdingthecatheter. Note:Thecathetermustnotbeforced.g. Cutoffendofthecatheterattachedtotunneler.
Pre-Attached Catheters
Createsubcutaneoustunnelfromtheportpocketsitetothevenousentrancesiteperthefollowing:a. Formtunnelbyadvancingthetipofthetunnelerfromtheportpocketsitetothevenousentrysite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.b. Connectthecathetertipintotheendofthetunneler.c. Pull the tunneler through to the venous entry site while gently holding the catheter. Note: Thecathetermustnotbeforced.d. Cutoffendofthecatheterattachedtotunneler.e. Estimate thecatheter length required for the tipplacementat the junctionof the superiorvenacavaand rightatriumby
placing the catheter on the chest along the venous path to the right atrium. Cut catheter to length at a 90˚ angle.
Connect Catheter ToPor t For Attachable Catheters
1. Flushallairfromeachlumenoftheportbodyusinga10mLsyringewithanon-coringneedlefilledwithsterilenormalsaline.Inserttheneedlethroughtheseptumandinjectthefluidwhilepointingthestemup.
2. Cleanse all system components with irrigation solution. Caution: Prior toadvancing thecatheter lock,ensure that thecatheter isproperlypositioned.Acatheternotadvanced to the
properregionmaynotseatsecurelyandleadtodislodgementandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
3. Connect catheter to port:a. Placecatheterlockbackontocatheter,ensuringtheblackradiopaqueringonthecatheterlockfacesawayfromtheportbody.b. Cutthecathetertotheproperlengthata90˚angle,allowingsufficientslackforbodymovementandportconnection.Check
catheterforanydamage.Ifanydamageisnoted,cutdamagedsectionoffbeforeconnectingcathetertoport.Note: Ensurethatnoguidewiresorstiffeningwiresremaininthecatheterlumenpriortocuttingandadjustingcathetertodesired length.
c. Forsinglelumenports,alignportstemwithcatheter.Whenplacingduallumenports,aligntheportstemwithbothlumens. Note:Ifthecatheterandcatheterlockareconnectedandthendisconnected,thecatheterendmustbere-trimmedtoensure
a secure re-connection. Note:Whenusingthecatheterlock,besuretheendcontainingacoloredradiopaqueringfacesawayfromtheport.Thecatheterlockshouldbesufficienttosecurecathetertoport.Note:Sterilegauzemaybeusedtofacilitatestem to catheter connection.
d. For single lumen ports: Advance catheter over port stem to midway point. Note: Advancingcatheter too far alongportstemcould leadto"mushrooming"of tubingwhenthecatheter lock isadvanced.Shouldthisoccur, it isadvisabletostopadvancingthecatheterlock,pullthecatheterbackalongthestemawayfromtheport,trimendofcatheterandre-assemblethe connection.
e. For dual lumen ports:Advancecathetercompletelyonstempriortoadvancingcatheterlock.Warning: Failure to completely advancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Warning:Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter.
Pos i t ionPor t AndClose Incis ionS i te
1. Place the port in the subcutaneous pocket away from the incision line. Secure the port to the underlying fascia using non-absorbable,monofilamentsutures.Leavesufficientslackinthecathetertopermitslightmovement,andverifythatthecatheterisnotkinked.Thiswillreducetheriskofportmigrationandthepossibilityofitflippingover.
Note:Whensuturingaportwithasiliconeportbody,placesuturethroughatleast2mmofsilicone.2. Aftersuturingtheportinthepocket,flushthewoundwithanappropriateantibioticsolution,perinstitutionalprotocol.
Stem
b. c.a. Catheter
Catheter LockStem Radiopaque Ring
ShoulderAdvance to midway point
Single Lumen PowerPor t* Device:
Stem
Shoulderb. c.a. Catheter
Catheter Lock
Warning: Advance catheter completelyon stem prior to advancing catheter lock
Advance all the way
Stem Radiopaque Ring
D ual Lumen PowerPor t* Device:
Descr ipt ion
ThePowerPort* implantableport is an implantableaccessdevicedesigned toprovide repeatedaccess to thevascular system.Portaccessisperformedbypercutaneousneedleinsertionusinganon-coringneedle.PowerinjectionisperformedusingaPowerLoc*BrandSafety InfusionSet**only.ThePowerPort*deviceconsistsof twoprimarycomponents:an injectionportwitha self-sealingsiliconeseptumandaradiopaquecatheter.SinglelumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopoftheseptumwhichincludesthreepalpationbumpsarrangedinatriangleandbypalpatingthesidesoftheport,whichisalsotriangular.DuallumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopofeachseptum;eachseptumfeaturesthreepalpationbumpsarrangedinatriangle.Allmaterialsarebiocompatible,canbeusedwithvirtuallyallinjectablesolutionsintendedformedicinaluse, includingthepower injectionofcontrastmedia. For implantableportswithGroshong*catheters, theGroshong*cathetervalvehelpsprovidesecurityagainstbloodrefluxandairembolismintotheport/cathetersystem.TheGroshong*cathetermaybeflushedwithnormalsaline,anditdoesnotrequireheparintomaintainpatency.
Indicat ions For Use
ThePowerPort*implantableportisindicatedforpatienttherapiesrequiringrepeatedaccesstothevascularsystem.Theportsystemcanbeusedforinfusionofmedications,I.V.fluids,parenteralnutritionsolutions,bloodproducts,andforthewithdrawalofbloodsamples.
WhenusedwithaPowerLoc*BrandSafetyInfusionSet**,thePowerPort*deviceisindicatedforpowerinjectionofcontrastmedia.Forpowerinjectionofcontrastmedia,themaximumrecommendedinfusionrateis5mL/s.
Contra indicat ions, Warnings, andPrecaut ions
Contraindications
Thisdeviceiscontraindicatedfor: • Catheterinsertioninthesubclavianveinmedialtotheborderofthefirstrib,anareawhichisassociatedwithhigherratesofpinch-
off.1,2Portmaybeplacedinlateralsubclavianveinbasedonevaluationbyaqualifiedpractitioner.• Whenthepresenceofdevice-relatedinfection,bacteremia,orsepticemiaisknownorsuspected.• Whenthepatient’sbodysizeisinsufficientforthesizeoftheimplanteddevice.• Whenthepatientisknownorissuspectedtobeallergictomaterialscontainedinthedevice.• Ifseverechronicobstructivelungdiseaseexists.• Iftheprospectiveinsertionsitehasbeenpreviouslyirradiated.• Iftheprospectiveplacementsitehaspreviouslysufferedepisodesofvenousthrombosisorvascularsurgicalprocedures.• Iflocaltissuefactorswillpreventproperdevicestabilizationand/oraccess.
Warnings
I. During Placement:• Intended for Single Use. Do not reuse. Reuse and/or repackagingmay create risk of patient or user infection, compromise the
structuralintegrityand/oressentialmaterialanddesigncharacteristicsofthedevice,whichmayleadtodevicefailureand/orleadtoinjury,illnessordeathofthepatient.
• Alcohol should not be used to soak or declot a polyurethane catheter because alcohol is known to degrade the polyurethanecatheter over time with repeated and prolonged exposure.
• After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice andapplicablelocal,stateandfederallawsandregulations.
• Place thumb over exposed opening of sheath or needle or attach syringe filledwith sterile normal saline solution tominimizebloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter,includingcatheterfragmentingand/orfracturing.
• Donotmanipulateapre-assembledorpre-connectedcatheter/portconnection,asthecathetercouldbecomedisconnectedfromtheport,orsystemdamagecouldoccur.
• Donotattempttomeasurethepatient’sbloodpressureonthearminwhichaperipheralsystemislocated,sincecatheterocclusionor other damage to the catheter could occur.
• Avoidvesselperforation.• Donotpowerinjectthroughaportsystemthatexhibitssignsofclavicle-firstribcompressionorpinch-offasitmayresultinport
systemfailure.• ForimplantableportswithGroshong*catheters,donotcutstylet.Withdrawstiffeningstyletfromcatheterpriortocutting.• Failuretocompletelyadvancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Examples of Radiopaque Identifiers
PowerPort* Implantable Port Features
PowerPort* Device Compatible Callout Tag
3 Palpation Bumps Arranged in a Triangle
PowerLoc* Brand Safety Infusion Set**
Triangular Shape
RadiopaqueidentifiersforPowerPort*devicesaidinidentificationasaBardpowerinjectableport.
*
*
*
*
63. Conductflowstudiesoneachlumenofthecatheterusinganon-coringneedleand10mLsyringetoconfirmthatthe flowisnotobstructed,thatnoleakexists,andthatthecatheteriscorrectlypositioned.4. Aspiratetoconfirmtheabilitytodrawblood.5. Flushandlockeachlumenoftheportsystemasdescribedunderheparinlockprocedureforopen-endedcathetersorsalinelock
proceduresforimplantableportswithGroshong*catheters. Closeclampwhileinjectinglast0.5mLofflushsolution. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.6. Closetheincisionsite,sothattheportdoesnotliebeneaththeincision.7. Apply dressing according to hospital practice.
Power In ject ionProcedure
1. Access the PowerPort* device with a PowerLoc* Brand Safety Infusion Set**. Make certain that the needle is longenough to be inserted fullywithin theport and that theneedle tiphasmade contactwith thebottomof theport reservoir. Warning: ThePowerPort*deviceisonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.
Note: Followinstitutionalprotocoltoverifycorrectcathetertippositionpriortopowerinjection.2. Attachasyringefilledwithsterilenormalsaline.3. Instructthepatienttoassumethepositiontheywillbeinduringthepowerinjectionprocedure,beforecheckingforpatency.If
possible,thepatientshouldreceivepowerinjectionwithhisorherarmverticallyabovetheshoulderwiththepalmofthehandon the faceof thegantryduring injection.This allows for uninterruptedpassageof injected contrast through the axillary andsubclavianveinsatthethoracicoutlet.
4. Aspirateforadequatebloodreturnandvigorouslyflushtheportwithat least10mLofsterilenormalsaline. Warning: Failure toensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.5. Detach syringe.6. Warmcontrastmediatobodytemperature.7. AttachthepowerinjectiondevicetothePowerLoc*BrandSafetyInfusionSet**ensuringconnectionissecure.Checkindicatedflow
rateofsafetyinfusionsetandconfirmpowerinjectorsettings. Warning: Donotexceeda300psipressurelimitsettingonthepowerinjectionmachine,orthemaximumrecommendedflowrate
onthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
8. Instructthepatienttocommunicateimmediatelyanypainorchangeinfeelingduringtheinjection.9. Injectcontrastmediawarmedtobodytemperature,takingcarenottoexceedtheflowratelimits. Warning:Iflocalpain,swellingorsignsofextravasationarenoted,theinjectionshouldbestoppedimmediately. Warning:Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.10. Disconnectthepowerinjectiondevice.11. Aftertherapycompletion,flusheachlumenoftheportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflush
solution.12. Perform heparin lock procedure or saline lock procedures for implanted ports with Groshong* catheters. For dual lumen
PowerPort*devices,flusheachlumenseparatelyandperformlockingproceduresoneachseptum. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.13. ToremovePowerLoc*BrandSafetyInfusionSet**fromtheport,activatesafetymechanismwhilewithdrawingneedleuntilyou
hear or feela "click"atwhichtimetheneedleshouldbecapturedwithinthesafetymechanismof thePowerLoc*BrandSafety
InfusionSet**.
DeterminingPor t SystemVolumes for Por t LockProcedures
Forportsystemvolumesandlockingprocedures,pleaserefertothepackaginginsert.
PowerLoc* Brand Safety Infusion Set** Gauge Size 19 Ga. 20 Ga. 22 Ga.
PowerLoc* Brand Safety Infusion Set** Gauge Color Cream Yellow Black
Maximum Recommended Flow Rate Setting 5mL/s 5mL/s 2mL/s
1II. During Port Access:• Do not use a syringe smaller than 10 mL. Flushing occluded catheters with small syringes can create excessive pressures within the port system.• PowerPort*implantableportsareonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.• Failuretowarmcontrastmediatobodytemperaturepriortopowerinjectionmayresultinportsystemfailure.• Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.• Powerinjectormachinepressurelimitingfeaturemaynotpreventoverpressurizationofanoccludedcatheter.• Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.• PowerPort*deviceindicationforpowerinjectionofcontrastmediaimpliestheport’sabilitytowithstandtheprocedure,butitdoes
not implyappropriatenessof theprocedureforaparticularpatientnor foraparticular infusionset.Asuitablytrainedclinician isresponsibleforevaluatingthehealthstatusofapatientasitpertainstoapowerinjectionprocedureandforevaluatingthesuitabilityofanyinfusionsetusedtoaccesstheport.
• Donotexceeda300psipressure limitsettingonthepower injectionmachine,orthemaximumrecommendedflowrateonthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
• Iflocalpain,swellingorsignsofextravasationarenotedduringpowerinjection,theinjectionshouldbestoppedimmediately.
Signs of Pinch-off
Clinical:• Difficultywithbloodwithdrawal• Resistancetoinfusionoffluids• Patientpositionchangesrequiredforinfusionoffluidsor bloodwithdrawal
Radiologic:• Grade 1 or 2 distortion on chest X-ray. Pinch-off should be
evaluated for degree of severity prior to explantation. Patientsindicatinganydegreeofcatheterdistortionattheclavicle/firstribareashouldbefolloweddiligently.Therearegradesofpinch-offthatshouldberecognizedwithappropriatechestx-rayasshowninthetableatright.3,4
Precautions
• Carefullyreadandfollowallinstructionsintheseinstructionsforuse.• Federal(U.S.A.)lawrestrictsthisdevicetosalebyorontheorderofaphysician.• Onlyqualifiedhealthcarepractitionersshouldinsert,manipulateandremovethesedevices.• Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.• Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandwireasaunittopreventtheneedle
fromdamagingorshearingtheguidewire.• Useonlynon-coringneedleswiththeport.• Priortoadvancingthecatheterlock,ensurethatthecatheterisproperlypositioned.Acatheternotadvancedtotheproperregion
maynotseatsecurelyandleadtodislodgmentandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
• Followuniversalprecautionswheninsertingandmaintainingthecatheter.• Followallcontraindications,warnings,precautionsandinstructionsforallinfusatesasspecifiedbytheirmanufacturers.• Precautionsareintendedtohelpavoidcatheterdamageand/orpatientinjury.
I. Prior to Placement:• Examinepackagecarefullybeforeopeningtoconfirmitsintegrityandthattheexpirationdatehasnotpassed.Thedeviceissupplied
inadoublesterilepackageand isnon-pyrogenic.Donotuse ifpackage isdamaged,openedor theexpirationdatehaspassed.Sterilizedbyethyleneoxide.Donotresterilize.
• Inspectkitforpresenceofallcomponents.• Checkpatient’srecords,andaskpatient,whethertheyhaveanyknownallergiestochemicalsormaterialsthatwillbeusedduring
the placement procedure.• Fill(prime)thedevicewithsterilenormalsalinesolutiontohelpavoidairembolism.• Whenusinganintroducerkit,verifythatthecatheterfitseasilythroughtheintroducersheath.• Whenutilizingportforarmplacement,theportshouldnotbeplacedintheaxillarycavity.• BardAccessSystems,Inc.recommendstheuseofcomponentsprovidedinthekit.Ifadditionalitemsaretobeused,checkforproper
fitpriortoutilization.Note:Portbody,catheterandcatheterlockcannotbereplacedwithcomponentsoutsidetheprovidedkit.
II. During Placement:• Donotallowaccidentaldevicecontactwithsharpinstruments.Mechanicaldamagemayoccur.Useonlysmoothedged,atraumatic
clampsorforceps.• Takecarenottoperforate,tear,orfracturethecatheterduringplacement.Afterassemblingcathetertoport,checkassemblyforleaks
or damage. • Donotusethecatheterifthereisanyevidenceofmechanicaldamageorleaking.• Donotbendcatheteratsharpanglesduringimplantation.Thiscancompromisecatheterpatency.• Carefullyfollowtheconnectiontechniquegivenintheseinstructionstoensurepropercatheterconnectionandtoavoidcatheter
damage.• Donotusesuturestosecurecathetertotheportstemasitcouldcollapseordamagethecatheter.• Whenusingpeel-apartintroducers:
-Carefullyinserttheintroducerandcathetertoavoidinadvertentpenetrationtovitalstructuresinthethorax.-Avoidbloodvesseldamagebymaintainingacatheterordilatorasinternalsupportwhenusingapeel-apartintroducer.-Avoidsheathdamagebysimultaneouslyadvancingthesheathanddilatorasasingleunitusingarotationalmotion.
• Neveruseacatheterlockthatappearscrackedorotherwisedamaged.
Grade Severity Recommended Action
Grade 0 Nodistortion Noaction
Grade 1Distortion present without luminal narrowing
Chestx-rayshouldbetakenevery one to three months to monitorprogressionofpinch-off to grade 2 distortion. Shoulderpositioningduringchestx-raysshouldbenotedasitcancontributetochanges in distortion grades.
Grade 2Distortion present without luminal narrowing
Removalofthecathetershouldbeconsidered.
Grade 3 Catheter transec-tionorfracture Promptremovalofthecatheter.
2 3III. AfterPlacement:• EncouragepatienttokeeppatientIDcardandpresentittocliniciansaccessingtheirport.• Careshouldbetakentoavoidexcessiveforcewhenaccessinganimplantedport.
Poss ible Compl icat ions
Theuseofasubcutaneousportprovidesanimportantmeansofvenousaccessforcriticallyillpatients.However,thepotentialexistsforseriouscomplications,includingthefollowing:
Theseandothercomplicationsarewelldocumentedinmedicalliteratureandshouldbecarefullyconsideredbeforeplacingtheport.
I mplantat ion I nstruc t ions
Pleasereadthroughcompleteimplantationinstructionsbeforeimplantingport,noting“Contraindications,Warnings,andPrecautions”and“PossibleComplications”sectionsofthismanualbeforebeginningprocedure.
Prevent ingPinch-Off
Theriskofpinch-offsyndromecanbeavoidedbyinsertingthecatheterviatheinternaljugularvein(IJ). Subclavianinsertionofthecathetermedialtotheborderofthefirstribmaycausecatheterpinch-off,whichinturnresultsinocclusioncausingportsystemfailureduringpowerinjection.
Ifyouchoosetoinsertthecatheterintothesubclavianvein,itshouldbeinsertedlateraltotheborderofthefirstriboratthejunctionwith the axillary vein because such insertionwill avoid compression of the catheter,which can cause damage and even sever thecatheter.Theuseofimageguidanceuponinsertionisstronglyrecommended.Aradiographicconfirmationofcatheterinsertionshouldbemadetoensurethatthecatheterisnotbeingpinched.
I mplantat ion Preparat ion
1. Selectimplantationproceduretobeused.2. Selectthesiteforportplacement. Note: Port pocket site selection should allow for port placement in an anatomic area that provides good port stability,
does not interfere with patient mobility or daily activities, does not create pressure points, has not previously beenirradiated, does not show signs of infection, and does not interfere with clothing. Ideally choose an implantation sitein the lateral infraclavicular region for cosmesis and functionality. For arm port placement, port site should be distalto the desired vein insertion site. Patient’s arm movement should be considered when determining the length of thecatheter and the final tip location. Consider the amount of cutaneous tissue over the port septum, as excessive tissuewill make access difficult. Conversely, too thin a tissue layer over the port may lead to tissue erosion. A tissue thickness of 0.5 cm to 2 cm is appropriate.
3. Completepatientimplantrecord,includinglengthofcatheterimplanted,productreordernumberandlotnumber.4. Performadequateanesthesia.5. Createsterilefieldandopentray. Note:Thecatheterandportmaybesoakedinsterilenormalsalinepriortoplacement.6. Surgicallyprepanddrapetheimplantationsite.7a. ForAttachableCatheters:Flusheachlumenofopen-endedcatheterswithsterilenormalsaline,throughtheflushingconnectorand
clampthecatheterclosedseveralcentimetersfromthedistal(port)end. Note:Clampedcathetersegmentswillbecutoffpriortoattachment.7b. ForPre-AttachedCatheters:Useanon-coringneedletoflushtheportandcathetersystemwithsterilenormalsaline.7c. ForGroshong*catheters:Flushcatheterwithsterilenormalsalinethroughthepre-loadedstyletconnector.8. PlacepatientintheTrendelenburgpositionwithheadturnedawayfromtheintendedvenipuncturesite.Forarmportplacement,
positionthearminanabducted,externallyrotatedposition. Note:Recommendedveinsforarmplacementarecephalic,basilic,ormedialcubitalbasilic. Note:Recommendedveinsforchestplacementare internal jugularor lateralsubclavian.Refer to the "Warnings"sectioncovering
catheterpinch-offifinsertingthecatheterviathesubclavianvein.
Percutaneous Procedure
1. Locate and access vessel with introducer needle attached to a syringe. 2. Aspirate gently as the insertion ismade. If the artery is entered, withdraw the needle and applymanual pressure for several
minutes.Ifthepleuralspaceisentered,withdrawtheneedleandevaluatepatientforpossiblepneumothorax.3. Whentheveinhasbeenentered,removethesyringeleavingtheneedleinplace. Warning:Placethumboverexposedopeningofsheathorneedleorattachsyringefilledwithsterilenormalsalinesolutiontominimize
bloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• AirEmbolism• AllergicReaction• Bleeding• BrachialPlexusInjury• CardiacArrhythmia• CardiacPuncture• CardiacTamponade• CatheterorPortErosionThrough
theSkin• CatheterEmbolism• CatheterOcclusion• Catheterorport-relatedSepsis• DamageorBreakageduetoCompression
betweentheClavicleandFirstRib• DeviceRotationorExtrusion
• Endocarditis• Extravasation• FibrinSheathFormation• GuidewireFragmentEmbolism• Hematoma• Hemothorax• Hydrothorax• Infection,includingbutnotlimitedtopocket,
cathetertunnel,and/orbloodstream• Inflammation,Necrosis,orScarringof SkinOverImplantArea• IntoleranceorReactionto
Implanted Device• LacerationofVesselsorViscus• Painatoraroundportpocketsite
• PerforationofVesselsorViscus• Pneumothorax• RisksNormallyAssociatedwithLocal orGeneralAnesthesia,Surgery,and Post-OperativeRecovery• SpontaneousCatheterTipMalposition orRetraction• ThoracicDuctInjury• Thromboembolism• VascularThrombosis• VesselErosion
4 If using a micropuncture set, insert the flexible end of themicropuncture guidewire into the introducer needle. Advance the
guidewireas farasappropriate.Verifycorrectpositioning,usingfluoroscopyorappropriatetechnology.Gentlywithdrawandremove the needle, while holding themicropuncture guidewire in position. Advance the small sheath and dilator togetherasaunitoverthemicropunctureguidewire,usingaslightrotationalmotion.Withdrawthedilatorandguidewire, leavingthemicrointroducer sheath in place.
Caution:Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removebothneedleandwireasaunittopreventtheneedlefromdamagingorshearingtheguidewire.
Warning:Place thumboveropeningof sheath tominimizeblood lossandpreventairembolism.The riskofairembolism isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
4. Straighten “J” tip of standard guidewire with tip straightener and insert tapered end of tip straightener into the needle (ormicrointroducersheathifusingamicropunctureset).Note: Donotadvanceguidewireifobstructionisencountered.
5. Removethetipstraightenerandadvancetheguidewireintothesuperiorvenacava.Advancetheguidewireasfarasappropriatefortheprocedure.Verifycorrectpositioningusingfluoroscopyorappropriatetechnology.
6. Gentlywithdrawandremoveneedle(ormicrointroducersheathifusingmicropunctureset). Caution: If theguidewiremustbewithdrawnwhile theneedle is inserted, removeboth theneedleandwireasaunit tohelp
preventtheneedlefromdamagingorshearingtheguidewire.
Peel -Apar t Sheath Introducer Instruct ions
1. Advance the vessel dilator and sheath introducer as a unit over the exposed wire using a rotational motion. Advance it into the vein asaunit,leavingatleast2cmofsheathexposed.
Note:Placementmaybefacilitatedbymakingasmallincisiontoeaseintroductionofvesseldilatorandsheathintroducer. Warning:Avoidvesselperforation.2. Releasethelockingmechanismandgentlywithdrawthevesseldilatorand“J”wire,leavingthesheathinplace. Warning:Placethumboverexposedopeningofsheathtominimizebloodlossandpreventairembolism.Theriskofairembolism
isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
3. Insertcatheter into thesheath.Advance thecatheter through thesheath into thevessel to thedesired infusionsite.Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacavaandtherightatrium.
4. Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.5. Graspthetwohandlesofthepeel-apartsheathandpulloutwardandupwardatthesametime.Peelthesheathawayfromthe
cathetercompletely.Makesurethecatheterisnotdislodgedfromvessel.
Cut-Down Procedure
1. Useacut-downincisiontoexposetheentryveinofchoice.2. Perform vessel incision after vessel is isolated and stabilized to prevent
bleedingandairembolism.3. Ifusingaveinpick,insertitstaperedendthroughtheincisionandadvance
itintothevessel.Thenslidethecathetertipintothegroovedundersideofthepick.
4. Advancethecathetertipintothevessel.5. Withdrawtheveinpick,ifused.6. Advancethecatheterintothevesseltothedesiredinfusionsite. Note:Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacava andtherightatruim.Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.
Catheter Tunnel ingProcedure
1. Createasubcutaneouspocketusingbluntdissection. Note:Doa trial placement to verify that thepocket is largeenough to accommodate theport and that theportdoesnot lie
beneaththeincision.
Attachable Catheters
Createasubcutaneoustunnelfromthevenoussitetotheportpocketsiteusingtunnelerorlongforcepsperthefollowing:a. Makeasmallincisionatthevenousentrysite.b. Inserttipoftunnelerintothesmallincision.c. Formtunnelbyadvancingtipoftunnelerfromthevenousentrysitetotheportpocketsite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.
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2b1 2a 3 5
Catheter Vein pick
Vessel
5d. Removecatheterlockfromthecatheter.ForimplantedportswithGroshong*catheters,removethecatheterlockand stiffenerstyletfromthecatheterpriortocuttingcathetertoappropriatelength. Warning: Donotcutstiffeningstylet.Withdrawstiffeningstyletfromcatheterpriortocutting. Caution:Neveruseacatheterlockthatappearscrackedorotherwisedamaged.e. Attachendofcatheterontothetunnelerbarbwithatwistingmotion. Note:Barbthreadsmustbecompletelycoveredbythecathetertoadequatelysecurethecatheterasitispulledthroughthe
tunnel.Asuturemaybetiedaroundthecatheterbetweenthetunnelerbodyandthelargebarbtoholditmoresecurely.f. Pullthetunnelerthroughtotheportpocketsitewhilegentlyholdingthecatheter. Note:Thecathetermustnotbeforced.g. Cutoffendofthecatheterattachedtotunneler.
Pre-Attached Catheters
Createsubcutaneoustunnelfromtheportpocketsitetothevenousentrancesiteperthefollowing:a. Formtunnelbyadvancingthetipofthetunnelerfromtheportpocketsitetothevenousentrysite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.b. Connectthecathetertipintotheendofthetunneler.c. Pull the tunneler through to the venous entry site while gently holding the catheter. Note: Thecathetermustnotbeforced.d. Cutoffendofthecatheterattachedtotunneler.e. Estimate thecatheter length required for the tipplacementat the junctionof the superiorvenacavaand rightatriumby
placing the catheter on the chest along the venous path to the right atrium. Cut catheter to length at a 90˚ angle.
Connect Catheter ToPor t For Attachable Catheters
1. Flushallairfromeachlumenoftheportbodyusinga10mLsyringewithanon-coringneedlefilledwithsterilenormalsaline.Inserttheneedlethroughtheseptumandinjectthefluidwhilepointingthestemup.
2. Cleanse all system components with irrigation solution. Caution: Prior toadvancing thecatheter lock,ensure that thecatheter isproperlypositioned.Acatheternotadvanced to the
properregionmaynotseatsecurelyandleadtodislodgementandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
3. Connect catheter to port:a. Placecatheterlockbackontocatheter,ensuringtheblackradiopaqueringonthecatheterlockfacesawayfromtheportbody.b. Cutthecathetertotheproperlengthata90˚angle,allowingsufficientslackforbodymovementandportconnection.Check
catheterforanydamage.Ifanydamageisnoted,cutdamagedsectionoffbeforeconnectingcathetertoport.Note: Ensurethatnoguidewiresorstiffeningwiresremaininthecatheterlumenpriortocuttingandadjustingcathetertodesired length.
c. Forsinglelumenports,alignportstemwithcatheter.Whenplacingduallumenports,aligntheportstemwithbothlumens. Note:Ifthecatheterandcatheterlockareconnectedandthendisconnected,thecatheterendmustbere-trimmedtoensure
a secure re-connection. Note:Whenusingthecatheterlock,besuretheendcontainingacoloredradiopaqueringfacesawayfromtheport.Thecatheterlockshouldbesufficienttosecurecathetertoport.Note:Sterilegauzemaybeusedtofacilitatestem to catheter connection.
d. For single lumen ports: Advance catheter over port stem to midway point. Note: Advancingcatheter too far alongportstemcould leadto"mushrooming"of tubingwhenthecatheter lock isadvanced.Shouldthisoccur, it isadvisabletostopadvancingthecatheterlock,pullthecatheterbackalongthestemawayfromtheport,trimendofcatheterandre-assemblethe connection.
e. For dual lumen ports:Advancecathetercompletelyonstempriortoadvancingcatheterlock.Warning: Failure to completely advancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Warning:Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter.
Pos i t ionPor t AndClose Incis ionS i te
1. Place the port in the subcutaneous pocket away from the incision line. Secure the port to the underlying fascia using non-absorbable,monofilamentsutures.Leavesufficientslackinthecathetertopermitslightmovement,andverifythatthecatheterisnotkinked.Thiswillreducetheriskofportmigrationandthepossibilityofitflippingover.
Note:Whensuturingaportwithasiliconeportbody,placesuturethroughatleast2mmofsilicone.2. Aftersuturingtheportinthepocket,flushthewoundwithanappropriateantibioticsolution,perinstitutionalprotocol.
Stem
b. c.a. Catheter
Catheter LockStem Radiopaque Ring
ShoulderAdvance to midway point
Single Lumen PowerPor t* Device:
Stem
Shoulderb. c.a. Catheter
Catheter Lock
Warning: Advance catheter completelyon stem prior to advancing catheter lock
Advance all the way
Stem Radiopaque Ring
D ual Lumen PowerPor t* Device:
Descr ipt ion
ThePowerPort* implantableport is an implantableaccessdevicedesigned toprovide repeatedaccess to thevascular system.Portaccessisperformedbypercutaneousneedleinsertionusinganon-coringneedle.PowerinjectionisperformedusingaPowerLoc*BrandSafety InfusionSet**only.ThePowerPort*deviceconsistsof twoprimarycomponents:an injectionportwitha self-sealingsiliconeseptumandaradiopaquecatheter.SinglelumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopoftheseptumwhichincludesthreepalpationbumpsarrangedinatriangleandbypalpatingthesidesoftheport,whichisalsotriangular.DuallumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopofeachseptum;eachseptumfeaturesthreepalpationbumpsarrangedinatriangle.Allmaterialsarebiocompatible,canbeusedwithvirtuallyallinjectablesolutionsintendedformedicinaluse, includingthepower injectionofcontrastmedia. For implantableportswithGroshong*catheters, theGroshong*cathetervalvehelpsprovidesecurityagainstbloodrefluxandairembolismintotheport/cathetersystem.TheGroshong*cathetermaybeflushedwithnormalsaline,anditdoesnotrequireheparintomaintainpatency.
Indicat ions For Use
ThePowerPort*implantableportisindicatedforpatienttherapiesrequiringrepeatedaccesstothevascularsystem.Theportsystemcanbeusedforinfusionofmedications,I.V.fluids,parenteralnutritionsolutions,bloodproducts,andforthewithdrawalofbloodsamples.
WhenusedwithaPowerLoc*BrandSafetyInfusionSet**,thePowerPort*deviceisindicatedforpowerinjectionofcontrastmedia.Forpowerinjectionofcontrastmedia,themaximumrecommendedinfusionrateis5mL/s.
Contra indicat ions, Warnings, andPrecaut ions
Contraindications
Thisdeviceiscontraindicatedfor: • Catheterinsertioninthesubclavianveinmedialtotheborderofthefirstrib,anareawhichisassociatedwithhigherratesofpinch-
off.1,2Portmaybeplacedinlateralsubclavianveinbasedonevaluationbyaqualifiedpractitioner.• Whenthepresenceofdevice-relatedinfection,bacteremia,orsepticemiaisknownorsuspected.• Whenthepatient’sbodysizeisinsufficientforthesizeoftheimplanteddevice.• Whenthepatientisknownorissuspectedtobeallergictomaterialscontainedinthedevice.• Ifseverechronicobstructivelungdiseaseexists.• Iftheprospectiveinsertionsitehasbeenpreviouslyirradiated.• Iftheprospectiveplacementsitehaspreviouslysufferedepisodesofvenousthrombosisorvascularsurgicalprocedures.• Iflocaltissuefactorswillpreventproperdevicestabilizationand/oraccess.
Warnings
I. During Placement:• Intended for Single Use. Do not reuse. Reuse and/or repackagingmay create risk of patient or user infection, compromise the
structuralintegrityand/oressentialmaterialanddesigncharacteristicsofthedevice,whichmayleadtodevicefailureand/orleadtoinjury,illnessordeathofthepatient.
• Alcohol should not be used to soak or declot a polyurethane catheter because alcohol is known to degrade the polyurethanecatheter over time with repeated and prolonged exposure.
• After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice andapplicablelocal,stateandfederallawsandregulations.
• Place thumb over exposed opening of sheath or needle or attach syringe filledwith sterile normal saline solution tominimizebloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter,includingcatheterfragmentingand/orfracturing.
• Donotmanipulateapre-assembledorpre-connectedcatheter/portconnection,asthecathetercouldbecomedisconnectedfromtheport,orsystemdamagecouldoccur.
• Donotattempttomeasurethepatient’sbloodpressureonthearminwhichaperipheralsystemislocated,sincecatheterocclusionor other damage to the catheter could occur.
• Avoidvesselperforation.• Donotpowerinjectthroughaportsystemthatexhibitssignsofclavicle-firstribcompressionorpinch-offasitmayresultinport
systemfailure.• ForimplantableportswithGroshong*catheters,donotcutstylet.Withdrawstiffeningstyletfromcatheterpriortocutting.• Failuretocompletelyadvancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Examples of Radiopaque Identifiers
PowerPort* Implantable Port Features
PowerPort* Device Compatible Callout Tag
3 Palpation Bumps Arranged in a Triangle
PowerLoc* Brand Safety Infusion Set**
Triangular Shape
RadiopaqueidentifiersforPowerPort*devicesaidinidentificationasaBardpowerinjectableport.
*
*
*
*
63. Conductflowstudiesoneachlumenofthecatheterusinganon-coringneedleand10mLsyringetoconfirmthatthe flowisnotobstructed,thatnoleakexists,andthatthecatheteriscorrectlypositioned.4. Aspiratetoconfirmtheabilitytodrawblood.5. Flushandlockeachlumenoftheportsystemasdescribedunderheparinlockprocedureforopen-endedcathetersorsalinelock
proceduresforimplantableportswithGroshong*catheters. Closeclampwhileinjectinglast0.5mLofflushsolution. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.6. Closetheincisionsite,sothattheportdoesnotliebeneaththeincision.7. Apply dressing according to hospital practice.
Power In ject ionProcedure
1. Access the PowerPort* device with a PowerLoc* Brand Safety Infusion Set**. Make certain that the needle is longenough to be inserted fullywithin theport and that theneedle tiphasmade contactwith thebottomof theport reservoir. Warning: ThePowerPort*deviceisonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.
Note: Followinstitutionalprotocoltoverifycorrectcathetertippositionpriortopowerinjection.2. Attachasyringefilledwithsterilenormalsaline.3. Instructthepatienttoassumethepositiontheywillbeinduringthepowerinjectionprocedure,beforecheckingforpatency.If
possible,thepatientshouldreceivepowerinjectionwithhisorherarmverticallyabovetheshoulderwiththepalmofthehandon the faceof thegantryduring injection.This allows for uninterruptedpassageof injected contrast through the axillary andsubclavianveinsatthethoracicoutlet.
4. Aspirateforadequatebloodreturnandvigorouslyflushtheportwithat least10mLofsterilenormalsaline. Warning: Failure toensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.5. Detach syringe.6. Warmcontrastmediatobodytemperature.7. AttachthepowerinjectiondevicetothePowerLoc*BrandSafetyInfusionSet**ensuringconnectionissecure.Checkindicatedflow
rateofsafetyinfusionsetandconfirmpowerinjectorsettings. Warning: Donotexceeda300psipressurelimitsettingonthepowerinjectionmachine,orthemaximumrecommendedflowrate
onthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
8. Instructthepatienttocommunicateimmediatelyanypainorchangeinfeelingduringtheinjection.9. Injectcontrastmediawarmedtobodytemperature,takingcarenottoexceedtheflowratelimits. Warning:Iflocalpain,swellingorsignsofextravasationarenoted,theinjectionshouldbestoppedimmediately. Warning:Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.10. Disconnectthepowerinjectiondevice.11. Aftertherapycompletion,flusheachlumenoftheportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflush
solution.12. Perform heparin lock procedure or saline lock procedures for implanted ports with Groshong* catheters. For dual lumen
PowerPort*devices,flusheachlumenseparatelyandperformlockingproceduresoneachseptum. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.13. ToremovePowerLoc*BrandSafetyInfusionSet**fromtheport,activatesafetymechanismwhilewithdrawingneedleuntilyou
hear or feela "click"atwhichtimetheneedleshouldbecapturedwithinthesafetymechanismof thePowerLoc*BrandSafety
InfusionSet**.
DeterminingPor t SystemVolumes for Por t LockProcedures
Forportsystemvolumesandlockingprocedures,pleaserefertothepackaginginsert.
PowerLoc* Brand Safety Infusion Set** Gauge Size 19 Ga. 20 Ga. 22 Ga.
PowerLoc* Brand Safety Infusion Set** Gauge Color Cream Yellow Black
Maximum Recommended Flow Rate Setting 5mL/s 5mL/s 2mL/s
1II. During Port Access:• Do not use a syringe smaller than 10 mL. Flushing occluded catheters with small syringes can create excessive pressures within the port system.• PowerPort*implantableportsareonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.• Failuretowarmcontrastmediatobodytemperaturepriortopowerinjectionmayresultinportsystemfailure.• Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.• Powerinjectormachinepressurelimitingfeaturemaynotpreventoverpressurizationofanoccludedcatheter.• Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.• PowerPort*deviceindicationforpowerinjectionofcontrastmediaimpliestheport’sabilitytowithstandtheprocedure,butitdoes
not implyappropriatenessof theprocedureforaparticularpatientnor foraparticular infusionset.Asuitablytrainedclinician isresponsibleforevaluatingthehealthstatusofapatientasitpertainstoapowerinjectionprocedureandforevaluatingthesuitabilityofanyinfusionsetusedtoaccesstheport.
• Donotexceeda300psipressure limitsettingonthepower injectionmachine,orthemaximumrecommendedflowrateonthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
• Iflocalpain,swellingorsignsofextravasationarenotedduringpowerinjection,theinjectionshouldbestoppedimmediately.
Signs of Pinch-off
Clinical:• Difficultywithbloodwithdrawal• Resistancetoinfusionoffluids• Patientpositionchangesrequiredforinfusionoffluidsor bloodwithdrawal
Radiologic:• Grade 1 or 2 distortion on chest X-ray. Pinch-off should be
evaluated for degree of severity prior to explantation. Patientsindicatinganydegreeofcatheterdistortionattheclavicle/firstribareashouldbefolloweddiligently.Therearegradesofpinch-offthatshouldberecognizedwithappropriatechestx-rayasshowninthetableatright.3,4
Precautions
• Carefullyreadandfollowallinstructionsintheseinstructionsforuse.• Federal(U.S.A.)lawrestrictsthisdevicetosalebyorontheorderofaphysician.• Onlyqualifiedhealthcarepractitionersshouldinsert,manipulateandremovethesedevices.• Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.• Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandwireasaunittopreventtheneedle
fromdamagingorshearingtheguidewire.• Useonlynon-coringneedleswiththeport.• Priortoadvancingthecatheterlock,ensurethatthecatheterisproperlypositioned.Acatheternotadvancedtotheproperregion
maynotseatsecurelyandleadtodislodgmentandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
• Followuniversalprecautionswheninsertingandmaintainingthecatheter.• Followallcontraindications,warnings,precautionsandinstructionsforallinfusatesasspecifiedbytheirmanufacturers.• Precautionsareintendedtohelpavoidcatheterdamageand/orpatientinjury.
I. Prior to Placement:• Examinepackagecarefullybeforeopeningtoconfirmitsintegrityandthattheexpirationdatehasnotpassed.Thedeviceissupplied
inadoublesterilepackageand isnon-pyrogenic.Donotuse ifpackage isdamaged,openedor theexpirationdatehaspassed.Sterilizedbyethyleneoxide.Donotresterilize.
• Inspectkitforpresenceofallcomponents.• Checkpatient’srecords,andaskpatient,whethertheyhaveanyknownallergiestochemicalsormaterialsthatwillbeusedduring
the placement procedure.• Fill(prime)thedevicewithsterilenormalsalinesolutiontohelpavoidairembolism.• Whenusinganintroducerkit,verifythatthecatheterfitseasilythroughtheintroducersheath.• Whenutilizingportforarmplacement,theportshouldnotbeplacedintheaxillarycavity.• BardAccessSystems,Inc.recommendstheuseofcomponentsprovidedinthekit.Ifadditionalitemsaretobeused,checkforproper
fitpriortoutilization.Note:Portbody,catheterandcatheterlockcannotbereplacedwithcomponentsoutsidetheprovidedkit.
II. During Placement:• Donotallowaccidentaldevicecontactwithsharpinstruments.Mechanicaldamagemayoccur.Useonlysmoothedged,atraumatic
clampsorforceps.• Takecarenottoperforate,tear,orfracturethecatheterduringplacement.Afterassemblingcathetertoport,checkassemblyforleaks
or damage. • Donotusethecatheterifthereisanyevidenceofmechanicaldamageorleaking.• Donotbendcatheteratsharpanglesduringimplantation.Thiscancompromisecatheterpatency.• Carefullyfollowtheconnectiontechniquegivenintheseinstructionstoensurepropercatheterconnectionandtoavoidcatheter
damage.• Donotusesuturestosecurecathetertotheportstemasitcouldcollapseordamagethecatheter.• Whenusingpeel-apartintroducers:
-Carefullyinserttheintroducerandcathetertoavoidinadvertentpenetrationtovitalstructuresinthethorax.-Avoidbloodvesseldamagebymaintainingacatheterordilatorasinternalsupportwhenusingapeel-apartintroducer.-Avoidsheathdamagebysimultaneouslyadvancingthesheathanddilatorasasingleunitusingarotationalmotion.
• Neveruseacatheterlockthatappearscrackedorotherwisedamaged.
Grade Severity Recommended Action
Grade 0 Nodistortion Noaction
Grade 1Distortion present without luminal narrowing
Chestx-rayshouldbetakenevery one to three months to monitorprogressionofpinch-off to grade 2 distortion. Shoulderpositioningduringchestx-raysshouldbenotedasitcancontributetochanges in distortion grades.
Grade 2Distortion present without luminal narrowing
Removalofthecathetershouldbeconsidered.
Grade 3 Catheter transec-tionorfracture Promptremovalofthecatheter.
2 3III. AfterPlacement:• EncouragepatienttokeeppatientIDcardandpresentittocliniciansaccessingtheirport.• Careshouldbetakentoavoidexcessiveforcewhenaccessinganimplantedport.
Poss ible Compl icat ions
Theuseofasubcutaneousportprovidesanimportantmeansofvenousaccessforcriticallyillpatients.However,thepotentialexistsforseriouscomplications,includingthefollowing:
Theseandothercomplicationsarewelldocumentedinmedicalliteratureandshouldbecarefullyconsideredbeforeplacingtheport.
I mplantat ion I nstruc t ions
Pleasereadthroughcompleteimplantationinstructionsbeforeimplantingport,noting“Contraindications,Warnings,andPrecautions”and“PossibleComplications”sectionsofthismanualbeforebeginningprocedure.
Prevent ingPinch-Off
Theriskofpinch-offsyndromecanbeavoidedbyinsertingthecatheterviatheinternaljugularvein(IJ). Subclavianinsertionofthecathetermedialtotheborderofthefirstribmaycausecatheterpinch-off,whichinturnresultsinocclusioncausingportsystemfailureduringpowerinjection.
Ifyouchoosetoinsertthecatheterintothesubclavianvein,itshouldbeinsertedlateraltotheborderofthefirstriboratthejunctionwith the axillary vein because such insertionwill avoid compression of the catheter,which can cause damage and even sever thecatheter.Theuseofimageguidanceuponinsertionisstronglyrecommended.Aradiographicconfirmationofcatheterinsertionshouldbemadetoensurethatthecatheterisnotbeingpinched.
I mplantat ion Preparat ion
1. Selectimplantationproceduretobeused.2. Selectthesiteforportplacement. Note: Port pocket site selection should allow for port placement in an anatomic area that provides good port stability,
does not interfere with patient mobility or daily activities, does not create pressure points, has not previously beenirradiated, does not show signs of infection, and does not interfere with clothing. Ideally choose an implantation sitein the lateral infraclavicular region for cosmesis and functionality. For arm port placement, port site should be distalto the desired vein insertion site. Patient’s arm movement should be considered when determining the length of thecatheter and the final tip location. Consider the amount of cutaneous tissue over the port septum, as excessive tissuewill make access difficult. Conversely, too thin a tissue layer over the port may lead to tissue erosion. A tissue thickness of 0.5 cm to 2 cm is appropriate.
3. Completepatientimplantrecord,includinglengthofcatheterimplanted,productreordernumberandlotnumber.4. Performadequateanesthesia.5. Createsterilefieldandopentray. Note:Thecatheterandportmaybesoakedinsterilenormalsalinepriortoplacement.6. Surgicallyprepanddrapetheimplantationsite.7a. ForAttachableCatheters:Flusheachlumenofopen-endedcatheterswithsterilenormalsaline,throughtheflushingconnectorand
clampthecatheterclosedseveralcentimetersfromthedistal(port)end. Note:Clampedcathetersegmentswillbecutoffpriortoattachment.7b. ForPre-AttachedCatheters:Useanon-coringneedletoflushtheportandcathetersystemwithsterilenormalsaline.7c. ForGroshong*catheters:Flushcatheterwithsterilenormalsalinethroughthepre-loadedstyletconnector.8. PlacepatientintheTrendelenburgpositionwithheadturnedawayfromtheintendedvenipuncturesite.Forarmportplacement,
positionthearminanabducted,externallyrotatedposition. Note:Recommendedveinsforarmplacementarecephalic,basilic,ormedialcubitalbasilic. Note:Recommendedveinsforchestplacementare internal jugularor lateralsubclavian.Refer to the "Warnings"sectioncovering
catheterpinch-offifinsertingthecatheterviathesubclavianvein.
Percutaneous Procedure
1. Locate and access vessel with introducer needle attached to a syringe. 2. Aspirate gently as the insertion ismade. If the artery is entered, withdraw the needle and applymanual pressure for several
minutes.Ifthepleuralspaceisentered,withdrawtheneedleandevaluatepatientforpossiblepneumothorax.3. Whentheveinhasbeenentered,removethesyringeleavingtheneedleinplace. Warning:Placethumboverexposedopeningofsheathorneedleorattachsyringefilledwithsterilenormalsalinesolutiontominimize
bloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• AirEmbolism• AllergicReaction• Bleeding• BrachialPlexusInjury• CardiacArrhythmia• CardiacPuncture• CardiacTamponade• CatheterorPortErosionThrough
theSkin• CatheterEmbolism• CatheterOcclusion• Catheterorport-relatedSepsis• DamageorBreakageduetoCompression
betweentheClavicleandFirstRib• DeviceRotationorExtrusion
• Endocarditis• Extravasation• FibrinSheathFormation• GuidewireFragmentEmbolism• Hematoma• Hemothorax• Hydrothorax• Infection,includingbutnotlimitedtopocket,
cathetertunnel,and/orbloodstream• Inflammation,Necrosis,orScarringof SkinOverImplantArea• IntoleranceorReactionto
Implanted Device• LacerationofVesselsorViscus• Painatoraroundportpocketsite
• PerforationofVesselsorViscus• Pneumothorax• RisksNormallyAssociatedwithLocal orGeneralAnesthesia,Surgery,and Post-OperativeRecovery• SpontaneousCatheterTipMalposition orRetraction• ThoracicDuctInjury• Thromboembolism• VascularThrombosis• VesselErosion
4 If using a micropuncture set, insert the flexible end of themicropuncture guidewire into the introducer needle. Advance the
guidewireas farasappropriate.Verifycorrectpositioning,usingfluoroscopyorappropriatetechnology.Gentlywithdrawandremove the needle, while holding themicropuncture guidewire in position. Advance the small sheath and dilator togetherasaunitoverthemicropunctureguidewire,usingaslightrotationalmotion.Withdrawthedilatorandguidewire, leavingthemicrointroducer sheath in place.
Caution:Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removebothneedleandwireasaunittopreventtheneedlefromdamagingorshearingtheguidewire.
Warning:Place thumboveropeningof sheath tominimizeblood lossandpreventairembolism.The riskofairembolism isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
4. Straighten “J” tip of standard guidewire with tip straightener and insert tapered end of tip straightener into the needle (ormicrointroducersheathifusingamicropunctureset).Note: Donotadvanceguidewireifobstructionisencountered.
5. Removethetipstraightenerandadvancetheguidewireintothesuperiorvenacava.Advancetheguidewireasfarasappropriatefortheprocedure.Verifycorrectpositioningusingfluoroscopyorappropriatetechnology.
6. Gentlywithdrawandremoveneedle(ormicrointroducersheathifusingmicropunctureset). Caution: If theguidewiremustbewithdrawnwhile theneedle is inserted, removeboth theneedleandwireasaunit tohelp
preventtheneedlefromdamagingorshearingtheguidewire.
Peel -Apar t Sheath Introducer Instruct ions
1. Advance the vessel dilator and sheath introducer as a unit over the exposed wire using a rotational motion. Advance it into the vein asaunit,leavingatleast2cmofsheathexposed.
Note:Placementmaybefacilitatedbymakingasmallincisiontoeaseintroductionofvesseldilatorandsheathintroducer. Warning:Avoidvesselperforation.2. Releasethelockingmechanismandgentlywithdrawthevesseldilatorand“J”wire,leavingthesheathinplace. Warning:Placethumboverexposedopeningofsheathtominimizebloodlossandpreventairembolism.Theriskofairembolism
isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
3. Insertcatheter into thesheath.Advance thecatheter through thesheath into thevessel to thedesired infusionsite.Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacavaandtherightatrium.
4. Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.5. Graspthetwohandlesofthepeel-apartsheathandpulloutwardandupwardatthesametime.Peelthesheathawayfromthe
cathetercompletely.Makesurethecatheterisnotdislodgedfromvessel.
Cut-Down Procedure
1. Useacut-downincisiontoexposetheentryveinofchoice.2. Perform vessel incision after vessel is isolated and stabilized to prevent
bleedingandairembolism.3. Ifusingaveinpick,insertitstaperedendthroughtheincisionandadvance
itintothevessel.Thenslidethecathetertipintothegroovedundersideofthepick.
4. Advancethecathetertipintothevessel.5. Withdrawtheveinpick,ifused.6. Advancethecatheterintothevesseltothedesiredinfusionsite. Note:Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacava andtherightatruim.Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.
Catheter Tunnel ingProcedure
1. Createasubcutaneouspocketusingbluntdissection. Note:Doa trial placement to verify that thepocket is largeenough to accommodate theport and that theportdoesnot lie
beneaththeincision.
Attachable Catheters
Createasubcutaneoustunnelfromthevenoussitetotheportpocketsiteusingtunnelerorlongforcepsperthefollowing:a. Makeasmallincisionatthevenousentrysite.b. Inserttipoftunnelerintothesmallincision.c. Formtunnelbyadvancingtipoftunnelerfromthevenousentrysitetotheportpocketsite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.
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2b1 2a 3 5
Catheter Vein pick
Vessel
5d. Removecatheterlockfromthecatheter.ForimplantedportswithGroshong*catheters,removethecatheterlockand stiffenerstyletfromthecatheterpriortocuttingcathetertoappropriatelength. Warning: Donotcutstiffeningstylet.Withdrawstiffeningstyletfromcatheterpriortocutting. Caution:Neveruseacatheterlockthatappearscrackedorotherwisedamaged.e. Attachendofcatheterontothetunnelerbarbwithatwistingmotion. Note:Barbthreadsmustbecompletelycoveredbythecathetertoadequatelysecurethecatheterasitispulledthroughthe
tunnel.Asuturemaybetiedaroundthecatheterbetweenthetunnelerbodyandthelargebarbtoholditmoresecurely.f. Pullthetunnelerthroughtotheportpocketsitewhilegentlyholdingthecatheter. Note:Thecathetermustnotbeforced.g. Cutoffendofthecatheterattachedtotunneler.
Pre-Attached Catheters
Createsubcutaneoustunnelfromtheportpocketsitetothevenousentrancesiteperthefollowing:a. Formtunnelbyadvancingthetipofthetunnelerfromtheportpocketsitetothevenousentrysite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.b. Connectthecathetertipintotheendofthetunneler.c. Pull the tunneler through to the venous entry site while gently holding the catheter. Note: Thecathetermustnotbeforced.d. Cutoffendofthecatheterattachedtotunneler.e. Estimate thecatheter length required for the tipplacementat the junctionof the superiorvenacavaand rightatriumby
placing the catheter on the chest along the venous path to the right atrium. Cut catheter to length at a 90˚ angle.
Connect Catheter ToPor t For Attachable Catheters
1. Flushallairfromeachlumenoftheportbodyusinga10mLsyringewithanon-coringneedlefilledwithsterilenormalsaline.Inserttheneedlethroughtheseptumandinjectthefluidwhilepointingthestemup.
2. Cleanse all system components with irrigation solution. Caution: Prior toadvancing thecatheter lock,ensure that thecatheter isproperlypositioned.Acatheternotadvanced to the
properregionmaynotseatsecurelyandleadtodislodgementandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
3. Connect catheter to port:a. Placecatheterlockbackontocatheter,ensuringtheblackradiopaqueringonthecatheterlockfacesawayfromtheportbody.b. Cutthecathetertotheproperlengthata90˚angle,allowingsufficientslackforbodymovementandportconnection.Check
catheterforanydamage.Ifanydamageisnoted,cutdamagedsectionoffbeforeconnectingcathetertoport.Note: Ensurethatnoguidewiresorstiffeningwiresremaininthecatheterlumenpriortocuttingandadjustingcathetertodesired length.
c. Forsinglelumenports,alignportstemwithcatheter.Whenplacingduallumenports,aligntheportstemwithbothlumens. Note:Ifthecatheterandcatheterlockareconnectedandthendisconnected,thecatheterendmustbere-trimmedtoensure
a secure re-connection. Note:Whenusingthecatheterlock,besuretheendcontainingacoloredradiopaqueringfacesawayfromtheport.Thecatheterlockshouldbesufficienttosecurecathetertoport.Note:Sterilegauzemaybeusedtofacilitatestem to catheter connection.
d. For single lumen ports: Advance catheter over port stem to midway point. Note: Advancingcatheter too far alongportstemcould leadto"mushrooming"of tubingwhenthecatheter lock isadvanced.Shouldthisoccur, it isadvisabletostopadvancingthecatheterlock,pullthecatheterbackalongthestemawayfromtheport,trimendofcatheterandre-assemblethe connection.
e. For dual lumen ports:Advancecathetercompletelyonstempriortoadvancingcatheterlock.Warning: Failure to completely advancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Warning:Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter.
Pos i t ionPor t AndClose Incis ionS i te
1. Place the port in the subcutaneous pocket away from the incision line. Secure the port to the underlying fascia using non-absorbable,monofilamentsutures.Leavesufficientslackinthecathetertopermitslightmovement,andverifythatthecatheterisnotkinked.Thiswillreducetheriskofportmigrationandthepossibilityofitflippingover.
Note:Whensuturingaportwithasiliconeportbody,placesuturethroughatleast2mmofsilicone.2. Aftersuturingtheportinthepocket,flushthewoundwithanappropriateantibioticsolution,perinstitutionalprotocol.
Stem
b. c.a. Catheter
Catheter LockStem Radiopaque Ring
ShoulderAdvance to midway point
Single Lumen PowerPor t* Device:
Stem
Shoulderb. c.a. Catheter
Catheter Lock
Warning: Advance catheter completelyon stem prior to advancing catheter lock
Advance all the way
Stem Radiopaque Ring
D ual Lumen PowerPor t* Device:
Descr ipt ion
ThePowerPort* implantableport is an implantableaccessdevicedesigned toprovide repeatedaccess to thevascular system.Portaccessisperformedbypercutaneousneedleinsertionusinganon-coringneedle.PowerinjectionisperformedusingaPowerLoc*BrandSafety InfusionSet**only.ThePowerPort*deviceconsistsof twoprimarycomponents:an injectionportwitha self-sealingsiliconeseptumandaradiopaquecatheter.SinglelumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopoftheseptumwhichincludesthreepalpationbumpsarrangedinatriangleandbypalpatingthesidesoftheport,whichisalsotriangular.DuallumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopofeachseptum;eachseptumfeaturesthreepalpationbumpsarrangedinatriangle.Allmaterialsarebiocompatible,canbeusedwithvirtuallyallinjectablesolutionsintendedformedicinaluse, includingthepower injectionofcontrastmedia. For implantableportswithGroshong*catheters, theGroshong*cathetervalvehelpsprovidesecurityagainstbloodrefluxandairembolismintotheport/cathetersystem.TheGroshong*cathetermaybeflushedwithnormalsaline,anditdoesnotrequireheparintomaintainpatency.
Indicat ions For Use
ThePowerPort*implantableportisindicatedforpatienttherapiesrequiringrepeatedaccesstothevascularsystem.Theportsystemcanbeusedforinfusionofmedications,I.V.fluids,parenteralnutritionsolutions,bloodproducts,andforthewithdrawalofbloodsamples.
WhenusedwithaPowerLoc*BrandSafetyInfusionSet**,thePowerPort*deviceisindicatedforpowerinjectionofcontrastmedia.Forpowerinjectionofcontrastmedia,themaximumrecommendedinfusionrateis5mL/s.
Contra indicat ions, Warnings, andPrecaut ions
Contraindications
Thisdeviceiscontraindicatedfor: • Catheterinsertioninthesubclavianveinmedialtotheborderofthefirstrib,anareawhichisassociatedwithhigherratesofpinch-
off.1,2Portmaybeplacedinlateralsubclavianveinbasedonevaluationbyaqualifiedpractitioner.• Whenthepresenceofdevice-relatedinfection,bacteremia,orsepticemiaisknownorsuspected.• Whenthepatient’sbodysizeisinsufficientforthesizeoftheimplanteddevice.• Whenthepatientisknownorissuspectedtobeallergictomaterialscontainedinthedevice.• Ifseverechronicobstructivelungdiseaseexists.• Iftheprospectiveinsertionsitehasbeenpreviouslyirradiated.• Iftheprospectiveplacementsitehaspreviouslysufferedepisodesofvenousthrombosisorvascularsurgicalprocedures.• Iflocaltissuefactorswillpreventproperdevicestabilizationand/oraccess.
Warnings
I. During Placement:• Intended for Single Use. Do not reuse. Reuse and/or repackagingmay create risk of patient or user infection, compromise the
structuralintegrityand/oressentialmaterialanddesigncharacteristicsofthedevice,whichmayleadtodevicefailureand/orleadtoinjury,illnessordeathofthepatient.
• Alcohol should not be used to soak or declot a polyurethane catheter because alcohol is known to degrade the polyurethanecatheter over time with repeated and prolonged exposure.
• After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice andapplicablelocal,stateandfederallawsandregulations.
• Place thumb over exposed opening of sheath or needle or attach syringe filledwith sterile normal saline solution tominimizebloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter,includingcatheterfragmentingand/orfracturing.
• Donotmanipulateapre-assembledorpre-connectedcatheter/portconnection,asthecathetercouldbecomedisconnectedfromtheport,orsystemdamagecouldoccur.
• Donotattempttomeasurethepatient’sbloodpressureonthearminwhichaperipheralsystemislocated,sincecatheterocclusionor other damage to the catheter could occur.
• Avoidvesselperforation.• Donotpowerinjectthroughaportsystemthatexhibitssignsofclavicle-firstribcompressionorpinch-offasitmayresultinport
systemfailure.• ForimplantableportswithGroshong*catheters,donotcutstylet.Withdrawstiffeningstyletfromcatheterpriortocutting.• Failuretocompletelyadvancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Examples of Radiopaque Identifiers
PowerPort* Implantable Port Features
PowerPort* Device Compatible Callout Tag
3 Palpation Bumps Arranged in a Triangle
PowerLoc* Brand Safety Infusion Set**
Triangular Shape
RadiopaqueidentifiersforPowerPort*devicesaidinidentificationasaBardpowerinjectableport.
*
*
*
*
63. Conductflowstudiesoneachlumenofthecatheterusinganon-coringneedleand10mLsyringetoconfirmthatthe flowisnotobstructed,thatnoleakexists,andthatthecatheteriscorrectlypositioned.4. Aspiratetoconfirmtheabilitytodrawblood.5. Flushandlockeachlumenoftheportsystemasdescribedunderheparinlockprocedureforopen-endedcathetersorsalinelock
proceduresforimplantableportswithGroshong*catheters. Closeclampwhileinjectinglast0.5mLofflushsolution. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.6. Closetheincisionsite,sothattheportdoesnotliebeneaththeincision.7. Apply dressing according to hospital practice.
Power In ject ionProcedure
1. Access the PowerPort* device with a PowerLoc* Brand Safety Infusion Set**. Make certain that the needle is longenough to be inserted fullywithin theport and that theneedle tiphasmade contactwith thebottomof theport reservoir. Warning: ThePowerPort*deviceisonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.
Note: Followinstitutionalprotocoltoverifycorrectcathetertippositionpriortopowerinjection.2. Attachasyringefilledwithsterilenormalsaline.3. Instructthepatienttoassumethepositiontheywillbeinduringthepowerinjectionprocedure,beforecheckingforpatency.If
possible,thepatientshouldreceivepowerinjectionwithhisorherarmverticallyabovetheshoulderwiththepalmofthehandon the faceof thegantryduring injection.This allows for uninterruptedpassageof injected contrast through the axillary andsubclavianveinsatthethoracicoutlet.
4. Aspirateforadequatebloodreturnandvigorouslyflushtheportwithat least10mLofsterilenormalsaline. Warning: Failure toensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.5. Detach syringe.6. Warmcontrastmediatobodytemperature.7. AttachthepowerinjectiondevicetothePowerLoc*BrandSafetyInfusionSet**ensuringconnectionissecure.Checkindicatedflow
rateofsafetyinfusionsetandconfirmpowerinjectorsettings. Warning: Donotexceeda300psipressurelimitsettingonthepowerinjectionmachine,orthemaximumrecommendedflowrate
onthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
8. Instructthepatienttocommunicateimmediatelyanypainorchangeinfeelingduringtheinjection.9. Injectcontrastmediawarmedtobodytemperature,takingcarenottoexceedtheflowratelimits. Warning:Iflocalpain,swellingorsignsofextravasationarenoted,theinjectionshouldbestoppedimmediately. Warning:Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.10. Disconnectthepowerinjectiondevice.11. Aftertherapycompletion,flusheachlumenoftheportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflush
solution.12. Perform heparin lock procedure or saline lock procedures for implanted ports with Groshong* catheters. For dual lumen
PowerPort*devices,flusheachlumenseparatelyandperformlockingproceduresoneachseptum. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.13. ToremovePowerLoc*BrandSafetyInfusionSet**fromtheport,activatesafetymechanismwhilewithdrawingneedleuntilyou
hear or feela "click"atwhichtimetheneedleshouldbecapturedwithinthesafetymechanismof thePowerLoc*BrandSafety
InfusionSet**.
DeterminingPor t SystemVolumes for Por t LockProcedures
Forportsystemvolumesandlockingprocedures,pleaserefertothepackaginginsert.
PowerLoc* Brand Safety Infusion Set** Gauge Size 19 Ga. 20 Ga. 22 Ga.
PowerLoc* Brand Safety Infusion Set** Gauge Color Cream Yellow Black
Maximum Recommended Flow Rate Setting 5mL/s 5mL/s 2mL/s
1II. During Port Access:• Do not use a syringe smaller than 10 mL. Flushing occluded catheters with small syringes can create excessive pressures within the port system.• PowerPort*implantableportsareonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.• Failuretowarmcontrastmediatobodytemperaturepriortopowerinjectionmayresultinportsystemfailure.• Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.• Powerinjectormachinepressurelimitingfeaturemaynotpreventoverpressurizationofanoccludedcatheter.• Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.• PowerPort*deviceindicationforpowerinjectionofcontrastmediaimpliestheport’sabilitytowithstandtheprocedure,butitdoes
not implyappropriatenessof theprocedureforaparticularpatientnor foraparticular infusionset.Asuitablytrainedclinician isresponsibleforevaluatingthehealthstatusofapatientasitpertainstoapowerinjectionprocedureandforevaluatingthesuitabilityofanyinfusionsetusedtoaccesstheport.
• Donotexceeda300psipressure limitsettingonthepower injectionmachine,orthemaximumrecommendedflowrateonthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
• Iflocalpain,swellingorsignsofextravasationarenotedduringpowerinjection,theinjectionshouldbestoppedimmediately.
Signs of Pinch-off
Clinical:• Difficultywithbloodwithdrawal• Resistancetoinfusionoffluids• Patientpositionchangesrequiredforinfusionoffluidsor bloodwithdrawal
Radiologic:• Grade 1 or 2 distortion on chest X-ray. Pinch-off should be
evaluated for degree of severity prior to explantation. Patientsindicatinganydegreeofcatheterdistortionattheclavicle/firstribareashouldbefolloweddiligently.Therearegradesofpinch-offthatshouldberecognizedwithappropriatechestx-rayasshowninthetableatright.3,4
Precautions
• Carefullyreadandfollowallinstructionsintheseinstructionsforuse.• Federal(U.S.A.)lawrestrictsthisdevicetosalebyorontheorderofaphysician.• Onlyqualifiedhealthcarepractitionersshouldinsert,manipulateandremovethesedevices.• Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.• Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandwireasaunittopreventtheneedle
fromdamagingorshearingtheguidewire.• Useonlynon-coringneedleswiththeport.• Priortoadvancingthecatheterlock,ensurethatthecatheterisproperlypositioned.Acatheternotadvancedtotheproperregion
maynotseatsecurelyandleadtodislodgmentandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
• Followuniversalprecautionswheninsertingandmaintainingthecatheter.• Followallcontraindications,warnings,precautionsandinstructionsforallinfusatesasspecifiedbytheirmanufacturers.• Precautionsareintendedtohelpavoidcatheterdamageand/orpatientinjury.
I. Prior to Placement:• Examinepackagecarefullybeforeopeningtoconfirmitsintegrityandthattheexpirationdatehasnotpassed.Thedeviceissupplied
inadoublesterilepackageand isnon-pyrogenic.Donotuse ifpackage isdamaged,openedor theexpirationdatehaspassed.Sterilizedbyethyleneoxide.Donotresterilize.
• Inspectkitforpresenceofallcomponents.• Checkpatient’srecords,andaskpatient,whethertheyhaveanyknownallergiestochemicalsormaterialsthatwillbeusedduring
the placement procedure.• Fill(prime)thedevicewithsterilenormalsalinesolutiontohelpavoidairembolism.• Whenusinganintroducerkit,verifythatthecatheterfitseasilythroughtheintroducersheath.• Whenutilizingportforarmplacement,theportshouldnotbeplacedintheaxillarycavity.• BardAccessSystems,Inc.recommendstheuseofcomponentsprovidedinthekit.Ifadditionalitemsaretobeused,checkforproper
fitpriortoutilization.Note:Portbody,catheterandcatheterlockcannotbereplacedwithcomponentsoutsidetheprovidedkit.
II. During Placement:• Donotallowaccidentaldevicecontactwithsharpinstruments.Mechanicaldamagemayoccur.Useonlysmoothedged,atraumatic
clampsorforceps.• Takecarenottoperforate,tear,orfracturethecatheterduringplacement.Afterassemblingcathetertoport,checkassemblyforleaks
or damage. • Donotusethecatheterifthereisanyevidenceofmechanicaldamageorleaking.• Donotbendcatheteratsharpanglesduringimplantation.Thiscancompromisecatheterpatency.• Carefullyfollowtheconnectiontechniquegivenintheseinstructionstoensurepropercatheterconnectionandtoavoidcatheter
damage.• Donotusesuturestosecurecathetertotheportstemasitcouldcollapseordamagethecatheter.• Whenusingpeel-apartintroducers:
-Carefullyinserttheintroducerandcathetertoavoidinadvertentpenetrationtovitalstructuresinthethorax.-Avoidbloodvesseldamagebymaintainingacatheterordilatorasinternalsupportwhenusingapeel-apartintroducer.-Avoidsheathdamagebysimultaneouslyadvancingthesheathanddilatorasasingleunitusingarotationalmotion.
• Neveruseacatheterlockthatappearscrackedorotherwisedamaged.
Grade Severity Recommended Action
Grade 0 Nodistortion Noaction
Grade 1Distortion present without luminal narrowing
Chestx-rayshouldbetakenevery one to three months to monitorprogressionofpinch-off to grade 2 distortion. Shoulderpositioningduringchestx-raysshouldbenotedasitcancontributetochanges in distortion grades.
Grade 2Distortion present without luminal narrowing
Removalofthecathetershouldbeconsidered.
Grade 3 Catheter transec-tionorfracture Promptremovalofthecatheter.
2 3III. AfterPlacement:• EncouragepatienttokeeppatientIDcardandpresentittocliniciansaccessingtheirport.• Careshouldbetakentoavoidexcessiveforcewhenaccessinganimplantedport.
Poss ible Compl icat ions
Theuseofasubcutaneousportprovidesanimportantmeansofvenousaccessforcriticallyillpatients.However,thepotentialexistsforseriouscomplications,includingthefollowing:
Theseandothercomplicationsarewelldocumentedinmedicalliteratureandshouldbecarefullyconsideredbeforeplacingtheport.
I mplantat ion I nstruc t ions
Pleasereadthroughcompleteimplantationinstructionsbeforeimplantingport,noting“Contraindications,Warnings,andPrecautions”and“PossibleComplications”sectionsofthismanualbeforebeginningprocedure.
Prevent ingPinch-Off
Theriskofpinch-offsyndromecanbeavoidedbyinsertingthecatheterviatheinternaljugularvein(IJ). Subclavianinsertionofthecathetermedialtotheborderofthefirstribmaycausecatheterpinch-off,whichinturnresultsinocclusioncausingportsystemfailureduringpowerinjection.
Ifyouchoosetoinsertthecatheterintothesubclavianvein,itshouldbeinsertedlateraltotheborderofthefirstriboratthejunctionwith the axillary vein because such insertionwill avoid compression of the catheter,which can cause damage and even sever thecatheter.Theuseofimageguidanceuponinsertionisstronglyrecommended.Aradiographicconfirmationofcatheterinsertionshouldbemadetoensurethatthecatheterisnotbeingpinched.
I mplantat ion Preparat ion
1. Selectimplantationproceduretobeused.2. Selectthesiteforportplacement. Note: Port pocket site selection should allow for port placement in an anatomic area that provides good port stability,
does not interfere with patient mobility or daily activities, does not create pressure points, has not previously beenirradiated, does not show signs of infection, and does not interfere with clothing. Ideally choose an implantation sitein the lateral infraclavicular region for cosmesis and functionality. For arm port placement, port site should be distalto the desired vein insertion site. Patient’s arm movement should be considered when determining the length of thecatheter and the final tip location. Consider the amount of cutaneous tissue over the port septum, as excessive tissuewill make access difficult. Conversely, too thin a tissue layer over the port may lead to tissue erosion. A tissue thickness of 0.5 cm to 2 cm is appropriate.
3. Completepatientimplantrecord,includinglengthofcatheterimplanted,productreordernumberandlotnumber.4. Performadequateanesthesia.5. Createsterilefieldandopentray. Note:Thecatheterandportmaybesoakedinsterilenormalsalinepriortoplacement.6. Surgicallyprepanddrapetheimplantationsite.7a. ForAttachableCatheters:Flusheachlumenofopen-endedcatheterswithsterilenormalsaline,throughtheflushingconnectorand
clampthecatheterclosedseveralcentimetersfromthedistal(port)end. Note:Clampedcathetersegmentswillbecutoffpriortoattachment.7b. ForPre-AttachedCatheters:Useanon-coringneedletoflushtheportandcathetersystemwithsterilenormalsaline.7c. ForGroshong*catheters:Flushcatheterwithsterilenormalsalinethroughthepre-loadedstyletconnector.8. PlacepatientintheTrendelenburgpositionwithheadturnedawayfromtheintendedvenipuncturesite.Forarmportplacement,
positionthearminanabducted,externallyrotatedposition. Note:Recommendedveinsforarmplacementarecephalic,basilic,ormedialcubitalbasilic. Note:Recommendedveinsforchestplacementare internal jugularor lateralsubclavian.Refer to the "Warnings"sectioncovering
catheterpinch-offifinsertingthecatheterviathesubclavianvein.
Percutaneous Procedure
1. Locate and access vessel with introducer needle attached to a syringe. 2. Aspirate gently as the insertion ismade. If the artery is entered, withdraw the needle and applymanual pressure for several
minutes.Ifthepleuralspaceisentered,withdrawtheneedleandevaluatepatientforpossiblepneumothorax.3. Whentheveinhasbeenentered,removethesyringeleavingtheneedleinplace. Warning:Placethumboverexposedopeningofsheathorneedleorattachsyringefilledwithsterilenormalsalinesolutiontominimize
bloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• AirEmbolism• AllergicReaction• Bleeding• BrachialPlexusInjury• CardiacArrhythmia• CardiacPuncture• CardiacTamponade• CatheterorPortErosionThrough
theSkin• CatheterEmbolism• CatheterOcclusion• Catheterorport-relatedSepsis• DamageorBreakageduetoCompression
betweentheClavicleandFirstRib• DeviceRotationorExtrusion
• Endocarditis• Extravasation• FibrinSheathFormation• GuidewireFragmentEmbolism• Hematoma• Hemothorax• Hydrothorax• Infection,includingbutnotlimitedtopocket,
cathetertunnel,and/orbloodstream• Inflammation,Necrosis,orScarringof SkinOverImplantArea• IntoleranceorReactionto
Implanted Device• LacerationofVesselsorViscus• Painatoraroundportpocketsite
• PerforationofVesselsorViscus• Pneumothorax• RisksNormallyAssociatedwithLocal orGeneralAnesthesia,Surgery,and Post-OperativeRecovery• SpontaneousCatheterTipMalposition orRetraction• ThoracicDuctInjury• Thromboembolism• VascularThrombosis• VesselErosion
4 If using a micropuncture set, insert the flexible end of themicropuncture guidewire into the introducer needle. Advance the
guidewireas farasappropriate.Verifycorrectpositioning,usingfluoroscopyorappropriatetechnology.Gentlywithdrawandremove the needle, while holding themicropuncture guidewire in position. Advance the small sheath and dilator togetherasaunitoverthemicropunctureguidewire,usingaslightrotationalmotion.Withdrawthedilatorandguidewire, leavingthemicrointroducer sheath in place.
Caution:Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removebothneedleandwireasaunittopreventtheneedlefromdamagingorshearingtheguidewire.
Warning:Place thumboveropeningof sheath tominimizeblood lossandpreventairembolism.The riskofairembolism isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
4. Straighten “J” tip of standard guidewire with tip straightener and insert tapered end of tip straightener into the needle (ormicrointroducersheathifusingamicropunctureset).Note: Donotadvanceguidewireifobstructionisencountered.
5. Removethetipstraightenerandadvancetheguidewireintothesuperiorvenacava.Advancetheguidewireasfarasappropriatefortheprocedure.Verifycorrectpositioningusingfluoroscopyorappropriatetechnology.
6. Gentlywithdrawandremoveneedle(ormicrointroducersheathifusingmicropunctureset). Caution: If theguidewiremustbewithdrawnwhile theneedle is inserted, removeboth theneedleandwireasaunit tohelp
preventtheneedlefromdamagingorshearingtheguidewire.
Peel -Apar t Sheath Introducer Instruct ions
1. Advance the vessel dilator and sheath introducer as a unit over the exposed wire using a rotational motion. Advance it into the vein asaunit,leavingatleast2cmofsheathexposed.
Note:Placementmaybefacilitatedbymakingasmallincisiontoeaseintroductionofvesseldilatorandsheathintroducer. Warning:Avoidvesselperforation.2. Releasethelockingmechanismandgentlywithdrawthevesseldilatorand“J”wire,leavingthesheathinplace. Warning:Placethumboverexposedopeningofsheathtominimizebloodlossandpreventairembolism.Theriskofairembolism
isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
3. Insertcatheter into thesheath.Advance thecatheter through thesheath into thevessel to thedesired infusionsite.Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacavaandtherightatrium.
4. Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.5. Graspthetwohandlesofthepeel-apartsheathandpulloutwardandupwardatthesametime.Peelthesheathawayfromthe
cathetercompletely.Makesurethecatheterisnotdislodgedfromvessel.
Cut-Down Procedure
1. Useacut-downincisiontoexposetheentryveinofchoice.2. Perform vessel incision after vessel is isolated and stabilized to prevent
bleedingandairembolism.3. Ifusingaveinpick,insertitstaperedendthroughtheincisionandadvance
itintothevessel.Thenslidethecathetertipintothegroovedundersideofthepick.
4. Advancethecathetertipintothevessel.5. Withdrawtheveinpick,ifused.6. Advancethecatheterintothevesseltothedesiredinfusionsite. Note:Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacava andtherightatruim.Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.
Catheter Tunnel ingProcedure
1. Createasubcutaneouspocketusingbluntdissection. Note:Doa trial placement to verify that thepocket is largeenough to accommodate theport and that theportdoesnot lie
beneaththeincision.
Attachable Catheters
Createasubcutaneoustunnelfromthevenoussitetotheportpocketsiteusingtunnelerorlongforcepsperthefollowing:a. Makeasmallincisionatthevenousentrysite.b. Inserttipoftunnelerintothesmallincision.c. Formtunnelbyadvancingtipoftunnelerfromthevenousentrysitetotheportpocketsite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.
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2b1 2a 3 5
Catheter Vein pick
Vessel
5d. Removecatheterlockfromthecatheter.ForimplantedportswithGroshong*catheters,removethecatheterlockand stiffenerstyletfromthecatheterpriortocuttingcathetertoappropriatelength. Warning: Donotcutstiffeningstylet.Withdrawstiffeningstyletfromcatheterpriortocutting. Caution:Neveruseacatheterlockthatappearscrackedorotherwisedamaged.e. Attachendofcatheterontothetunnelerbarbwithatwistingmotion. Note:Barbthreadsmustbecompletelycoveredbythecathetertoadequatelysecurethecatheterasitispulledthroughthe
tunnel.Asuturemaybetiedaroundthecatheterbetweenthetunnelerbodyandthelargebarbtoholditmoresecurely.f. Pullthetunnelerthroughtotheportpocketsitewhilegentlyholdingthecatheter. Note:Thecathetermustnotbeforced.g. Cutoffendofthecatheterattachedtotunneler.
Pre-Attached Catheters
Createsubcutaneoustunnelfromtheportpocketsitetothevenousentrancesiteperthefollowing:a. Formtunnelbyadvancingthetipofthetunnelerfromtheportpocketsitetothevenousentrysite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.b. Connectthecathetertipintotheendofthetunneler.c. Pull the tunneler through to the venous entry site while gently holding the catheter. Note: Thecathetermustnotbeforced.d. Cutoffendofthecatheterattachedtotunneler.e. Estimate thecatheter length required for the tipplacementat the junctionof the superiorvenacavaand rightatriumby
placing the catheter on the chest along the venous path to the right atrium. Cut catheter to length at a 90˚ angle.
Connect Catheter ToPor t For Attachable Catheters
1. Flushallairfromeachlumenoftheportbodyusinga10mLsyringewithanon-coringneedlefilledwithsterilenormalsaline.Inserttheneedlethroughtheseptumandinjectthefluidwhilepointingthestemup.
2. Cleanse all system components with irrigation solution. Caution: Prior toadvancing thecatheter lock,ensure that thecatheter isproperlypositioned.Acatheternotadvanced to the
properregionmaynotseatsecurelyandleadtodislodgementandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
3. Connect catheter to port:a. Placecatheterlockbackontocatheter,ensuringtheblackradiopaqueringonthecatheterlockfacesawayfromtheportbody.b. Cutthecathetertotheproperlengthata90˚angle,allowingsufficientslackforbodymovementandportconnection.Check
catheterforanydamage.Ifanydamageisnoted,cutdamagedsectionoffbeforeconnectingcathetertoport.Note: Ensurethatnoguidewiresorstiffeningwiresremaininthecatheterlumenpriortocuttingandadjustingcathetertodesired length.
c. Forsinglelumenports,alignportstemwithcatheter.Whenplacingduallumenports,aligntheportstemwithbothlumens. Note:Ifthecatheterandcatheterlockareconnectedandthendisconnected,thecatheterendmustbere-trimmedtoensure
a secure re-connection. Note:Whenusingthecatheterlock,besuretheendcontainingacoloredradiopaqueringfacesawayfromtheport.Thecatheterlockshouldbesufficienttosecurecathetertoport.Note:Sterilegauzemaybeusedtofacilitatestem to catheter connection.
d. For single lumen ports: Advance catheter over port stem to midway point. Note: Advancingcatheter too far alongportstemcould leadto"mushrooming"of tubingwhenthecatheter lock isadvanced.Shouldthisoccur, it isadvisabletostopadvancingthecatheterlock,pullthecatheterbackalongthestemawayfromtheport,trimendofcatheterandre-assemblethe connection.
e. For dual lumen ports:Advancecathetercompletelyonstempriortoadvancingcatheterlock.Warning: Failure to completely advancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Warning:Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter.
Pos i t ionPor t AndClose Incis ionS i te
1. Place the port in the subcutaneous pocket away from the incision line. Secure the port to the underlying fascia using non-absorbable,monofilamentsutures.Leavesufficientslackinthecathetertopermitslightmovement,andverifythatthecatheterisnotkinked.Thiswillreducetheriskofportmigrationandthepossibilityofitflippingover.
Note:Whensuturingaportwithasiliconeportbody,placesuturethroughatleast2mmofsilicone.2. Aftersuturingtheportinthepocket,flushthewoundwithanappropriateantibioticsolution,perinstitutionalprotocol.
Stem
b. c.a. Catheter
Catheter LockStem Radiopaque Ring
ShoulderAdvance to midway point
Single Lumen PowerPor t* Device:
Stem
Shoulderb. c.a. Catheter
Catheter Lock
Warning: Advance catheter completelyon stem prior to advancing catheter lock
Advance all the way
Stem Radiopaque Ring
D ual Lumen PowerPor t* Device:
Descr ipt ion
ThePowerPort* implantableport is an implantableaccessdevicedesigned toprovide repeatedaccess to thevascular system.Portaccessisperformedbypercutaneousneedleinsertionusinganon-coringneedle.PowerinjectionisperformedusingaPowerLoc*BrandSafety InfusionSet**only.ThePowerPort*deviceconsistsof twoprimarycomponents:an injectionportwitha self-sealingsiliconeseptumandaradiopaquecatheter.SinglelumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopoftheseptumwhichincludesthreepalpationbumpsarrangedinatriangleandbypalpatingthesidesoftheport,whichisalsotriangular.DuallumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopofeachseptum;eachseptumfeaturesthreepalpationbumpsarrangedinatriangle.Allmaterialsarebiocompatible,canbeusedwithvirtuallyallinjectablesolutionsintendedformedicinaluse, includingthepower injectionofcontrastmedia. For implantableportswithGroshong*catheters, theGroshong*cathetervalvehelpsprovidesecurityagainstbloodrefluxandairembolismintotheport/cathetersystem.TheGroshong*cathetermaybeflushedwithnormalsaline,anditdoesnotrequireheparintomaintainpatency.
Indicat ions For Use
ThePowerPort*implantableportisindicatedforpatienttherapiesrequiringrepeatedaccesstothevascularsystem.Theportsystemcanbeusedforinfusionofmedications,I.V.fluids,parenteralnutritionsolutions,bloodproducts,andforthewithdrawalofbloodsamples.
WhenusedwithaPowerLoc*BrandSafetyInfusionSet**,thePowerPort*deviceisindicatedforpowerinjectionofcontrastmedia.Forpowerinjectionofcontrastmedia,themaximumrecommendedinfusionrateis5mL/s.
Contra indicat ions, Warnings, andPrecaut ions
Contraindications
Thisdeviceiscontraindicatedfor: • Catheterinsertioninthesubclavianveinmedialtotheborderofthefirstrib,anareawhichisassociatedwithhigherratesofpinch-
off.1,2Portmaybeplacedinlateralsubclavianveinbasedonevaluationbyaqualifiedpractitioner.• Whenthepresenceofdevice-relatedinfection,bacteremia,orsepticemiaisknownorsuspected.• Whenthepatient’sbodysizeisinsufficientforthesizeoftheimplanteddevice.• Whenthepatientisknownorissuspectedtobeallergictomaterialscontainedinthedevice.• Ifseverechronicobstructivelungdiseaseexists.• Iftheprospectiveinsertionsitehasbeenpreviouslyirradiated.• Iftheprospectiveplacementsitehaspreviouslysufferedepisodesofvenousthrombosisorvascularsurgicalprocedures.• Iflocaltissuefactorswillpreventproperdevicestabilizationand/oraccess.
Warnings
I. During Placement:• Intended for Single Use. Do not reuse. Reuse and/or repackagingmay create risk of patient or user infection, compromise the
structuralintegrityand/oressentialmaterialanddesigncharacteristicsofthedevice,whichmayleadtodevicefailureand/orleadtoinjury,illnessordeathofthepatient.
• Alcohol should not be used to soak or declot a polyurethane catheter because alcohol is known to degrade the polyurethanecatheter over time with repeated and prolonged exposure.
• After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice andapplicablelocal,stateandfederallawsandregulations.
• Place thumb over exposed opening of sheath or needle or attach syringe filledwith sterile normal saline solution tominimizebloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter,includingcatheterfragmentingand/orfracturing.
• Donotmanipulateapre-assembledorpre-connectedcatheter/portconnection,asthecathetercouldbecomedisconnectedfromtheport,orsystemdamagecouldoccur.
• Donotattempttomeasurethepatient’sbloodpressureonthearminwhichaperipheralsystemislocated,sincecatheterocclusionor other damage to the catheter could occur.
• Avoidvesselperforation.• Donotpowerinjectthroughaportsystemthatexhibitssignsofclavicle-firstribcompressionorpinch-offasitmayresultinport
systemfailure.• ForimplantableportswithGroshong*catheters,donotcutstylet.Withdrawstiffeningstyletfromcatheterpriortocutting.• Failuretocompletelyadvancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Examples of Radiopaque Identifiers
PowerPort* Implantable Port Features
PowerPort* Device Compatible Callout Tag
3 Palpation Bumps Arranged in a Triangle
PowerLoc* Brand Safety Infusion Set**
Triangular Shape
RadiopaqueidentifiersforPowerPort*devicesaidinidentificationasaBardpowerinjectableport.
*
*
*
*
63. Conductflowstudiesoneachlumenofthecatheterusinganon-coringneedleand10mLsyringetoconfirmthatthe flowisnotobstructed,thatnoleakexists,andthatthecatheteriscorrectlypositioned.4. Aspiratetoconfirmtheabilitytodrawblood.5. Flushandlockeachlumenoftheportsystemasdescribedunderheparinlockprocedureforopen-endedcathetersorsalinelock
proceduresforimplantableportswithGroshong*catheters. Closeclampwhileinjectinglast0.5mLofflushsolution. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.6. Closetheincisionsite,sothattheportdoesnotliebeneaththeincision.7. Apply dressing according to hospital practice.
Power In ject ionProcedure
1. Access the PowerPort* device with a PowerLoc* Brand Safety Infusion Set**. Make certain that the needle is longenough to be inserted fullywithin theport and that theneedle tiphasmade contactwith thebottomof theport reservoir. Warning: ThePowerPort*deviceisonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.
Note: Followinstitutionalprotocoltoverifycorrectcathetertippositionpriortopowerinjection.2. Attachasyringefilledwithsterilenormalsaline.3. Instructthepatienttoassumethepositiontheywillbeinduringthepowerinjectionprocedure,beforecheckingforpatency.If
possible,thepatientshouldreceivepowerinjectionwithhisorherarmverticallyabovetheshoulderwiththepalmofthehandon the faceof thegantryduring injection.This allows for uninterruptedpassageof injected contrast through the axillary andsubclavianveinsatthethoracicoutlet.
4. Aspirateforadequatebloodreturnandvigorouslyflushtheportwithat least10mLofsterilenormalsaline. Warning: Failure toensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.5. Detach syringe.6. Warmcontrastmediatobodytemperature.7. AttachthepowerinjectiondevicetothePowerLoc*BrandSafetyInfusionSet**ensuringconnectionissecure.Checkindicatedflow
rateofsafetyinfusionsetandconfirmpowerinjectorsettings. Warning: Donotexceeda300psipressurelimitsettingonthepowerinjectionmachine,orthemaximumrecommendedflowrate
onthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
8. Instructthepatienttocommunicateimmediatelyanypainorchangeinfeelingduringtheinjection.9. Injectcontrastmediawarmedtobodytemperature,takingcarenottoexceedtheflowratelimits. Warning:Iflocalpain,swellingorsignsofextravasationarenoted,theinjectionshouldbestoppedimmediately. Warning:Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.10. Disconnectthepowerinjectiondevice.11. Aftertherapycompletion,flusheachlumenoftheportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflush
solution.12. Perform heparin lock procedure or saline lock procedures for implanted ports with Groshong* catheters. For dual lumen
PowerPort*devices,flusheachlumenseparatelyandperformlockingproceduresoneachseptum. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.13. ToremovePowerLoc*BrandSafetyInfusionSet**fromtheport,activatesafetymechanismwhilewithdrawingneedleuntilyou
hear or feela "click"atwhichtimetheneedleshouldbecapturedwithinthesafetymechanismof thePowerLoc*BrandSafety
InfusionSet**.
DeterminingPor t SystemVolumes for Por t LockProcedures
Forportsystemvolumesandlockingprocedures,pleaserefertothepackaginginsert.
PowerLoc* Brand Safety Infusion Set** Gauge Size 19 Ga. 20 Ga. 22 Ga.
PowerLoc* Brand Safety Infusion Set** Gauge Color Cream Yellow Black
Maximum Recommended Flow Rate Setting 5mL/s 5mL/s 2mL/s
1II. During Port Access:• Do not use a syringe smaller than 10 mL. Flushing occluded catheters with small syringes can create excessive pressures within the port system.• PowerPort*implantableportsareonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.• Failuretowarmcontrastmediatobodytemperaturepriortopowerinjectionmayresultinportsystemfailure.• Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.• Powerinjectormachinepressurelimitingfeaturemaynotpreventoverpressurizationofanoccludedcatheter.• Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.• PowerPort*deviceindicationforpowerinjectionofcontrastmediaimpliestheport’sabilitytowithstandtheprocedure,butitdoes
not implyappropriatenessof theprocedureforaparticularpatientnor foraparticular infusionset.Asuitablytrainedclinician isresponsibleforevaluatingthehealthstatusofapatientasitpertainstoapowerinjectionprocedureandforevaluatingthesuitabilityofanyinfusionsetusedtoaccesstheport.
• Donotexceeda300psipressure limitsettingonthepower injectionmachine,orthemaximumrecommendedflowrateonthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
• Iflocalpain,swellingorsignsofextravasationarenotedduringpowerinjection,theinjectionshouldbestoppedimmediately.
Signs of Pinch-off
Clinical:• Difficultywithbloodwithdrawal• Resistancetoinfusionoffluids• Patientpositionchangesrequiredforinfusionoffluidsor bloodwithdrawal
Radiologic:• Grade 1 or 2 distortion on chest X-ray. Pinch-off should be
evaluated for degree of severity prior to explantation. Patientsindicatinganydegreeofcatheterdistortionattheclavicle/firstribareashouldbefolloweddiligently.Therearegradesofpinch-offthatshouldberecognizedwithappropriatechestx-rayasshowninthetableatright.3,4
Precautions
• Carefullyreadandfollowallinstructionsintheseinstructionsforuse.• Federal(U.S.A.)lawrestrictsthisdevicetosalebyorontheorderofaphysician.• Onlyqualifiedhealthcarepractitionersshouldinsert,manipulateandremovethesedevices.• Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.• Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandwireasaunittopreventtheneedle
fromdamagingorshearingtheguidewire.• Useonlynon-coringneedleswiththeport.• Priortoadvancingthecatheterlock,ensurethatthecatheterisproperlypositioned.Acatheternotadvancedtotheproperregion
maynotseatsecurelyandleadtodislodgmentandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
• Followuniversalprecautionswheninsertingandmaintainingthecatheter.• Followallcontraindications,warnings,precautionsandinstructionsforallinfusatesasspecifiedbytheirmanufacturers.• Precautionsareintendedtohelpavoidcatheterdamageand/orpatientinjury.
I. Prior to Placement:• Examinepackagecarefullybeforeopeningtoconfirmitsintegrityandthattheexpirationdatehasnotpassed.Thedeviceissupplied
inadoublesterilepackageand isnon-pyrogenic.Donotuse ifpackage isdamaged,openedor theexpirationdatehaspassed.Sterilizedbyethyleneoxide.Donotresterilize.
• Inspectkitforpresenceofallcomponents.• Checkpatient’srecords,andaskpatient,whethertheyhaveanyknownallergiestochemicalsormaterialsthatwillbeusedduring
the placement procedure.• Fill(prime)thedevicewithsterilenormalsalinesolutiontohelpavoidairembolism.• Whenusinganintroducerkit,verifythatthecatheterfitseasilythroughtheintroducersheath.• Whenutilizingportforarmplacement,theportshouldnotbeplacedintheaxillarycavity.• BardAccessSystems,Inc.recommendstheuseofcomponentsprovidedinthekit.Ifadditionalitemsaretobeused,checkforproper
fitpriortoutilization.Note:Portbody,catheterandcatheterlockcannotbereplacedwithcomponentsoutsidetheprovidedkit.
II. During Placement:• Donotallowaccidentaldevicecontactwithsharpinstruments.Mechanicaldamagemayoccur.Useonlysmoothedged,atraumatic
clampsorforceps.• Takecarenottoperforate,tear,orfracturethecatheterduringplacement.Afterassemblingcathetertoport,checkassemblyforleaks
or damage. • Donotusethecatheterifthereisanyevidenceofmechanicaldamageorleaking.• Donotbendcatheteratsharpanglesduringimplantation.Thiscancompromisecatheterpatency.• Carefullyfollowtheconnectiontechniquegivenintheseinstructionstoensurepropercatheterconnectionandtoavoidcatheter
damage.• Donotusesuturestosecurecathetertotheportstemasitcouldcollapseordamagethecatheter.• Whenusingpeel-apartintroducers:
-Carefullyinserttheintroducerandcathetertoavoidinadvertentpenetrationtovitalstructuresinthethorax.-Avoidbloodvesseldamagebymaintainingacatheterordilatorasinternalsupportwhenusingapeel-apartintroducer.-Avoidsheathdamagebysimultaneouslyadvancingthesheathanddilatorasasingleunitusingarotationalmotion.
• Neveruseacatheterlockthatappearscrackedorotherwisedamaged.
Grade Severity Recommended Action
Grade 0 Nodistortion Noaction
Grade 1Distortion present without luminal narrowing
Chestx-rayshouldbetakenevery one to three months to monitorprogressionofpinch-off to grade 2 distortion. Shoulderpositioningduringchestx-raysshouldbenotedasitcancontributetochanges in distortion grades.
Grade 2Distortion present without luminal narrowing
Removalofthecathetershouldbeconsidered.
Grade 3 Catheter transec-tionorfracture Promptremovalofthecatheter.
2 3III. AfterPlacement:• EncouragepatienttokeeppatientIDcardandpresentittocliniciansaccessingtheirport.• Careshouldbetakentoavoidexcessiveforcewhenaccessinganimplantedport.
Poss ible Compl icat ions
Theuseofasubcutaneousportprovidesanimportantmeansofvenousaccessforcriticallyillpatients.However,thepotentialexistsforseriouscomplications,includingthefollowing:
Theseandothercomplicationsarewelldocumentedinmedicalliteratureandshouldbecarefullyconsideredbeforeplacingtheport.
I mplantat ion I nstruc t ions
Pleasereadthroughcompleteimplantationinstructionsbeforeimplantingport,noting“Contraindications,Warnings,andPrecautions”and“PossibleComplications”sectionsofthismanualbeforebeginningprocedure.
Prevent ingPinch-Off
Theriskofpinch-offsyndromecanbeavoidedbyinsertingthecatheterviatheinternaljugularvein(IJ). Subclavianinsertionofthecathetermedialtotheborderofthefirstribmaycausecatheterpinch-off,whichinturnresultsinocclusioncausingportsystemfailureduringpowerinjection.
Ifyouchoosetoinsertthecatheterintothesubclavianvein,itshouldbeinsertedlateraltotheborderofthefirstriboratthejunctionwith the axillary vein because such insertionwill avoid compression of the catheter,which can cause damage and even sever thecatheter.Theuseofimageguidanceuponinsertionisstronglyrecommended.Aradiographicconfirmationofcatheterinsertionshouldbemadetoensurethatthecatheterisnotbeingpinched.
I mplantat ion Preparat ion
1. Selectimplantationproceduretobeused.2. Selectthesiteforportplacement. Note: Port pocket site selection should allow for port placement in an anatomic area that provides good port stability,
does not interfere with patient mobility or daily activities, does not create pressure points, has not previously beenirradiated, does not show signs of infection, and does not interfere with clothing. Ideally choose an implantation sitein the lateral infraclavicular region for cosmesis and functionality. For arm port placement, port site should be distalto the desired vein insertion site. Patient’s arm movement should be considered when determining the length of thecatheter and the final tip location. Consider the amount of cutaneous tissue over the port septum, as excessive tissuewill make access difficult. Conversely, too thin a tissue layer over the port may lead to tissue erosion. A tissue thickness of 0.5 cm to 2 cm is appropriate.
3. Completepatientimplantrecord,includinglengthofcatheterimplanted,productreordernumberandlotnumber.4. Performadequateanesthesia.5. Createsterilefieldandopentray. Note:Thecatheterandportmaybesoakedinsterilenormalsalinepriortoplacement.6. Surgicallyprepanddrapetheimplantationsite.7a. ForAttachableCatheters:Flusheachlumenofopen-endedcatheterswithsterilenormalsaline,throughtheflushingconnectorand
clampthecatheterclosedseveralcentimetersfromthedistal(port)end. Note:Clampedcathetersegmentswillbecutoffpriortoattachment.7b. ForPre-AttachedCatheters:Useanon-coringneedletoflushtheportandcathetersystemwithsterilenormalsaline.7c. ForGroshong*catheters:Flushcatheterwithsterilenormalsalinethroughthepre-loadedstyletconnector.8. PlacepatientintheTrendelenburgpositionwithheadturnedawayfromtheintendedvenipuncturesite.Forarmportplacement,
positionthearminanabducted,externallyrotatedposition. Note:Recommendedveinsforarmplacementarecephalic,basilic,ormedialcubitalbasilic. Note:Recommendedveinsforchestplacementare internal jugularor lateralsubclavian.Refer to the "Warnings"sectioncovering
catheterpinch-offifinsertingthecatheterviathesubclavianvein.
Percutaneous Procedure
1. Locate and access vessel with introducer needle attached to a syringe. 2. Aspirate gently as the insertion ismade. If the artery is entered, withdraw the needle and applymanual pressure for several
minutes.Ifthepleuralspaceisentered,withdrawtheneedleandevaluatepatientforpossiblepneumothorax.3. Whentheveinhasbeenentered,removethesyringeleavingtheneedleinplace. Warning:Placethumboverexposedopeningofsheathorneedleorattachsyringefilledwithsterilenormalsalinesolutiontominimize
bloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• AirEmbolism• AllergicReaction• Bleeding• BrachialPlexusInjury• CardiacArrhythmia• CardiacPuncture• CardiacTamponade• CatheterorPortErosionThrough
theSkin• CatheterEmbolism• CatheterOcclusion• Catheterorport-relatedSepsis• DamageorBreakageduetoCompression
betweentheClavicleandFirstRib• DeviceRotationorExtrusion
• Endocarditis• Extravasation• FibrinSheathFormation• GuidewireFragmentEmbolism• Hematoma• Hemothorax• Hydrothorax• Infection,includingbutnotlimitedtopocket,
cathetertunnel,and/orbloodstream• Inflammation,Necrosis,orScarringof SkinOverImplantArea• IntoleranceorReactionto
Implanted Device• LacerationofVesselsorViscus• Painatoraroundportpocketsite
• PerforationofVesselsorViscus• Pneumothorax• RisksNormallyAssociatedwithLocal orGeneralAnesthesia,Surgery,and Post-OperativeRecovery• SpontaneousCatheterTipMalposition orRetraction• ThoracicDuctInjury• Thromboembolism• VascularThrombosis• VesselErosion
4 If using a micropuncture set, insert the flexible end of themicropuncture guidewire into the introducer needle. Advance the
guidewireas farasappropriate.Verifycorrectpositioning,usingfluoroscopyorappropriatetechnology.Gentlywithdrawandremove the needle, while holding themicropuncture guidewire in position. Advance the small sheath and dilator togetherasaunitoverthemicropunctureguidewire,usingaslightrotationalmotion.Withdrawthedilatorandguidewire, leavingthemicrointroducer sheath in place.
Caution:Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removebothneedleandwireasaunittopreventtheneedlefromdamagingorshearingtheguidewire.
Warning:Place thumboveropeningof sheath tominimizeblood lossandpreventairembolism.The riskofairembolism isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
4. Straighten “J” tip of standard guidewire with tip straightener and insert tapered end of tip straightener into the needle (ormicrointroducersheathifusingamicropunctureset).Note: Donotadvanceguidewireifobstructionisencountered.
5. Removethetipstraightenerandadvancetheguidewireintothesuperiorvenacava.Advancetheguidewireasfarasappropriatefortheprocedure.Verifycorrectpositioningusingfluoroscopyorappropriatetechnology.
6. Gentlywithdrawandremoveneedle(ormicrointroducersheathifusingmicropunctureset). Caution: If theguidewiremustbewithdrawnwhile theneedle is inserted, removeboth theneedleandwireasaunit tohelp
preventtheneedlefromdamagingorshearingtheguidewire.
Peel -Apar t Sheath Introducer Instruct ions
1. Advance the vessel dilator and sheath introducer as a unit over the exposed wire using a rotational motion. Advance it into the vein asaunit,leavingatleast2cmofsheathexposed.
Note:Placementmaybefacilitatedbymakingasmallincisiontoeaseintroductionofvesseldilatorandsheathintroducer. Warning:Avoidvesselperforation.2. Releasethelockingmechanismandgentlywithdrawthevesseldilatorand“J”wire,leavingthesheathinplace. Warning:Placethumboverexposedopeningofsheathtominimizebloodlossandpreventairembolism.Theriskofairembolism
isreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
3. Insertcatheter into thesheath.Advance thecatheter through thesheath into thevessel to thedesired infusionsite.Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacavaandtherightatrium.
4. Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.5. Graspthetwohandlesofthepeel-apartsheathandpulloutwardandupwardatthesametime.Peelthesheathawayfromthe
cathetercompletely.Makesurethecatheterisnotdislodgedfromvessel.
Cut-Down Procedure
1. Useacut-downincisiontoexposetheentryveinofchoice.2. Perform vessel incision after vessel is isolated and stabilized to prevent
bleedingandairembolism.3. Ifusingaveinpick,insertitstaperedendthroughtheincisionandadvance
itintothevessel.Thenslidethecathetertipintothegroovedundersideofthepick.
4. Advancethecathetertipintothevessel.5. Withdrawtheveinpick,ifused.6. Advancethecatheterintothevesseltothedesiredinfusionsite. Note:Cathetersshouldbepositionedwiththecathetertipatthejunctionofthesuperiorvenacava andtherightatruim.Verifycorrectcathetertippositionusingfluoroscopyorappropriatetechnology.
Catheter Tunnel ingProcedure
1. Createasubcutaneouspocketusingbluntdissection. Note:Doa trial placement to verify that thepocket is largeenough to accommodate theport and that theportdoesnot lie
beneaththeincision.
Attachable Catheters
Createasubcutaneoustunnelfromthevenoussitetotheportpocketsiteusingtunnelerorlongforcepsperthefollowing:a. Makeasmallincisionatthevenousentrysite.b. Inserttipoftunnelerintothesmallincision.c. Formtunnelbyadvancingtipoftunnelerfromthevenousentrysitetotheportpocketsite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.
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Catheter Vein pick
Vessel
5d. Removecatheterlockfromthecatheter.ForimplantedportswithGroshong*catheters,removethecatheterlockand stiffenerstyletfromthecatheterpriortocuttingcathetertoappropriatelength. Warning: Donotcutstiffeningstylet.Withdrawstiffeningstyletfromcatheterpriortocutting. Caution:Neveruseacatheterlockthatappearscrackedorotherwisedamaged.e. Attachendofcatheterontothetunnelerbarbwithatwistingmotion. Note:Barbthreadsmustbecompletelycoveredbythecathetertoadequatelysecurethecatheterasitispulledthroughthe
tunnel.Asuturemaybetiedaroundthecatheterbetweenthetunnelerbodyandthelargebarbtoholditmoresecurely.f. Pullthetunnelerthroughtotheportpocketsitewhilegentlyholdingthecatheter. Note:Thecathetermustnotbeforced.g. Cutoffendofthecatheterattachedtotunneler.
Pre-Attached Catheters
Createsubcutaneoustunnelfromtheportpocketsitetothevenousentrancesiteperthefollowing:a. Formtunnelbyadvancingthetipofthetunnelerfromtheportpocketsitetothevenousentrysite. Caution:Avoidinadvertentpunctureoftheskinorfasciawiththetipofthetunneler.b. Connectthecathetertipintotheendofthetunneler.c. Pull the tunneler through to the venous entry site while gently holding the catheter. Note: Thecathetermustnotbeforced.d. Cutoffendofthecatheterattachedtotunneler.e. Estimate thecatheter length required for the tipplacementat the junctionof the superiorvenacavaand rightatriumby
placing the catheter on the chest along the venous path to the right atrium. Cut catheter to length at a 90˚ angle.
Connect Catheter ToPor t For Attachable Catheters
1. Flushallairfromeachlumenoftheportbodyusinga10mLsyringewithanon-coringneedlefilledwithsterilenormalsaline.Inserttheneedlethroughtheseptumandinjectthefluidwhilepointingthestemup.
2. Cleanse all system components with irrigation solution. Caution: Prior toadvancing thecatheter lock,ensure that thecatheter isproperlypositioned.Acatheternotadvanced to the
properregionmaynotseatsecurelyandleadtodislodgementandextravasation.Thecathetermustbestraightwithnosignofkinking.Aslightpullonthecatheterissufficienttostraightenit.Advancingthecatheterlockoverakinkedcathetermaydamagethecatheter.Donotholdthecatheterorcathlockwithanyinstrumentsthatcouldpotentiallydamageeitherpiece(e.g.hemostats).
3. Connect catheter to port:a. Placecatheterlockbackontocatheter,ensuringtheblackradiopaqueringonthecatheterlockfacesawayfromtheportbody.b. Cutthecathetertotheproperlengthata90˚angle,allowingsufficientslackforbodymovementandportconnection.Check
catheterforanydamage.Ifanydamageisnoted,cutdamagedsectionoffbeforeconnectingcathetertoport.Note: Ensurethatnoguidewiresorstiffeningwiresremaininthecatheterlumenpriortocuttingandadjustingcathetertodesired length.
c. Forsinglelumenports,alignportstemwithcatheter.Whenplacingduallumenports,aligntheportstemwithbothlumens. Note:Ifthecatheterandcatheterlockareconnectedandthendisconnected,thecatheterendmustbere-trimmedtoensure
a secure re-connection. Note:Whenusingthecatheterlock,besuretheendcontainingacoloredradiopaqueringfacesawayfromtheport.Thecatheterlockshouldbesufficienttosecurecathetertoport.Note:Sterilegauzemaybeusedtofacilitatestem to catheter connection.
d. For single lumen ports: Advance catheter over port stem to midway point. Note: Advancingcatheter too far alongportstemcould leadto"mushrooming"of tubingwhenthecatheter lock isadvanced.Shouldthisoccur, it isadvisabletostopadvancingthecatheterlock,pullthecatheterbackalongthestemawayfromtheport,trimendofcatheterandre-assemblethe connection.
e. For dual lumen ports:Advancecathetercompletelyonstempriortoadvancingcatheterlock.Warning: Failure to completely advancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Warning:Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter.
Pos i t ionPor t AndClose Incis ionS i te
1. Place the port in the subcutaneous pocket away from the incision line. Secure the port to the underlying fascia using non-absorbable,monofilamentsutures.Leavesufficientslackinthecathetertopermitslightmovement,andverifythatthecatheterisnotkinked.Thiswillreducetheriskofportmigrationandthepossibilityofitflippingover.
Note:Whensuturingaportwithasiliconeportbody,placesuturethroughatleast2mmofsilicone.2. Aftersuturingtheportinthepocket,flushthewoundwithanappropriateantibioticsolution,perinstitutionalprotocol.
Stem
b. c.a. Catheter
Catheter LockStem Radiopaque Ring
ShoulderAdvance to midway point
Single Lumen PowerPor t* Device:
Stem
Shoulderb. c.a. Catheter
Catheter Lock
Warning: Advance catheter completelyon stem prior to advancing catheter lock
Advance all the way
Stem Radiopaque Ring
D ual Lumen PowerPor t* Device:
Descr ipt ion
ThePowerPort* implantableport is an implantableaccessdevicedesigned toprovide repeatedaccess to thevascular system.Portaccessisperformedbypercutaneousneedleinsertionusinganon-coringneedle.PowerinjectionisperformedusingaPowerLoc*BrandSafety InfusionSet**only.ThePowerPort*deviceconsistsof twoprimarycomponents:an injectionportwitha self-sealingsiliconeseptumandaradiopaquecatheter.SinglelumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopoftheseptumwhichincludesthreepalpationbumpsarrangedinatriangleandbypalpatingthesidesoftheport,whichisalsotriangular.DuallumenPowerPort*implantableportscanbeidentifiedsubcutaneouslybyfeelingthetopofeachseptum;eachseptumfeaturesthreepalpationbumpsarrangedinatriangle.Allmaterialsarebiocompatible,canbeusedwithvirtuallyallinjectablesolutionsintendedformedicinaluse, includingthepower injectionofcontrastmedia. For implantableportswithGroshong*catheters, theGroshong*cathetervalvehelpsprovidesecurityagainstbloodrefluxandairembolismintotheport/cathetersystem.TheGroshong*cathetermaybeflushedwithnormalsaline,anditdoesnotrequireheparintomaintainpatency.
Indicat ions For Use
ThePowerPort*implantableportisindicatedforpatienttherapiesrequiringrepeatedaccesstothevascularsystem.Theportsystemcanbeusedforinfusionofmedications,I.V.fluids,parenteralnutritionsolutions,bloodproducts,andforthewithdrawalofbloodsamples.
WhenusedwithaPowerLoc*BrandSafetyInfusionSet**,thePowerPort*deviceisindicatedforpowerinjectionofcontrastmedia.Forpowerinjectionofcontrastmedia,themaximumrecommendedinfusionrateis5mL/s.
Contra indicat ions, Warnings, andPrecaut ions
Contraindications
Thisdeviceiscontraindicatedfor: • Catheterinsertioninthesubclavianveinmedialtotheborderofthefirstrib,anareawhichisassociatedwithhigherratesofpinch-
off.1,2Portmaybeplacedinlateralsubclavianveinbasedonevaluationbyaqualifiedpractitioner.• Whenthepresenceofdevice-relatedinfection,bacteremia,orsepticemiaisknownorsuspected.• Whenthepatient’sbodysizeisinsufficientforthesizeoftheimplanteddevice.• Whenthepatientisknownorissuspectedtobeallergictomaterialscontainedinthedevice.• Ifseverechronicobstructivelungdiseaseexists.• Iftheprospectiveinsertionsitehasbeenpreviouslyirradiated.• Iftheprospectiveplacementsitehaspreviouslysufferedepisodesofvenousthrombosisorvascularsurgicalprocedures.• Iflocaltissuefactorswillpreventproperdevicestabilizationand/oraccess.
Warnings
I. During Placement:• Intended for Single Use. Do not reuse. Reuse and/or repackagingmay create risk of patient or user infection, compromise the
structuralintegrityand/oressentialmaterialanddesigncharacteristicsofthedevice,whichmayleadtodevicefailureand/orleadtoinjury,illnessordeathofthepatient.
• Alcohol should not be used to soak or declot a polyurethane catheter because alcohol is known to degrade the polyurethanecatheter over time with repeated and prolonged exposure.
• After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice andapplicablelocal,stateandfederallawsandregulations.
• Place thumb over exposed opening of sheath or needle or attach syringe filledwith sterile normal saline solution tominimizebloodlossandpreventairembolism.TheriskofairembolismisreducedbyperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuverand/orinTrendelenburgposition.
• Donotsuturecathetertoport,portstem,orsurroundingtissue.Anydamageorconstrictionofcathetermaycompromisepowerinjectionperformanceandcatheterintegrity.BardAccessSystems,Inc.doesnotrecommendsuturingaroundthecatheterasdoingsocouldcompress,kink,ordamagecatheter,includingcatheterfragmentingand/orfracturing.
• Donotmanipulateapre-assembledorpre-connectedcatheter/portconnection,asthecathetercouldbecomedisconnectedfromtheport,orsystemdamagecouldoccur.
• Donotattempttomeasurethepatient’sbloodpressureonthearminwhichaperipheralsystemislocated,sincecatheterocclusionor other damage to the catheter could occur.
• Avoidvesselperforation.• Donotpowerinjectthroughaportsystemthatexhibitssignsofclavicle-firstribcompressionorpinch-offasitmayresultinport
systemfailure.• ForimplantableportswithGroshong*catheters,donotcutstylet.Withdrawstiffeningstyletfromcatheterpriortocutting.• Failuretocompletelyadvancethecatheterontheduallumenstemmayresultinsubcutaneousleakage.
Examples of Radiopaque Identifiers
PowerPort* Implantable Port Features
PowerPort* Device Compatible Callout Tag
3 Palpation Bumps Arranged in a Triangle
PowerLoc* Brand Safety Infusion Set**
Triangular Shape
RadiopaqueidentifiersforPowerPort*devicesaidinidentificationasaBardpowerinjectableport.
*
*
*
*
63. Conductflowstudiesoneachlumenofthecatheterusinganon-coringneedleand10mLsyringetoconfirmthatthe flowisnotobstructed,thatnoleakexists,andthatthecatheteriscorrectlypositioned.4. Aspiratetoconfirmtheabilitytodrawblood.5. Flushandlockeachlumenoftheportsystemasdescribedunderheparinlockprocedureforopen-endedcathetersorsalinelock
proceduresforimplantableportswithGroshong*catheters. Closeclampwhileinjectinglast0.5mLofflushsolution. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.6. Closetheincisionsite,sothattheportdoesnotliebeneaththeincision.7. Apply dressing according to hospital practice.
Power In ject ionProcedure
1. Access the PowerPort* device with a PowerLoc* Brand Safety Infusion Set**. Make certain that the needle is longenough to be inserted fullywithin theport and that theneedle tiphasmade contactwith thebottomof theport reservoir. Warning: ThePowerPort*deviceisonlypowerinjectablewhenaccessedwithaPowerLoc*BrandSafetyInfusionSet**.
Note: Followinstitutionalprotocoltoverifycorrectcathetertippositionpriortopowerinjection.2. Attachasyringefilledwithsterilenormalsaline.3. Instructthepatienttoassumethepositiontheywillbeinduringthepowerinjectionprocedure,beforecheckingforpatency.If
possible,thepatientshouldreceivepowerinjectionwithhisorherarmverticallyabovetheshoulderwiththepalmofthehandon the faceof thegantryduring injection.This allows for uninterruptedpassageof injected contrast through the axillary andsubclavianveinsatthethoracicoutlet.
4. Aspirateforadequatebloodreturnandvigorouslyflushtheportwithat least10mLofsterilenormalsaline. Warning: Failure toensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.5. Detach syringe.6. Warmcontrastmediatobodytemperature.7. AttachthepowerinjectiondevicetothePowerLoc*BrandSafetyInfusionSet**ensuringconnectionissecure.Checkindicatedflow
rateofsafetyinfusionsetandconfirmpowerinjectorsettings. Warning: Donotexceeda300psipressurelimitsettingonthepowerinjectionmachine,orthemaximumrecommendedflowrate
onthePowerLoc*needle,ifpowerinjectingthroughthePowerPort*device.
8. Instructthepatienttocommunicateimmediatelyanypainorchangeinfeelingduringtheinjection.9. Injectcontrastmediawarmedtobodytemperature,takingcarenottoexceedtheflowratelimits. Warning:Iflocalpain,swellingorsignsofextravasationarenoted,theinjectionshouldbestoppedimmediately. Warning:Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.10. Disconnectthepowerinjectiondevice.11. Aftertherapycompletion,flusheachlumenoftheportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflush
solution.12. Perform heparin lock procedure or saline lock procedures for implanted ports with Groshong* catheters. For dual lumen
PowerPort*devices,flusheachlumenseparatelyandperformlockingproceduresoneachseptum. Caution: Rememberthatsomepatientsmaybehyper-sensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT).
Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.13. ToremovePowerLoc*BrandSafetyInfusionSet**fromtheport,activatesafetymechanismwhilewithdrawingneedleuntilyou
hear or feela "click"atwhichtimetheneedleshouldbecapturedwithinthesafetymechanismof thePowerLoc*BrandSafety
InfusionSet**.
DeterminingPor t SystemVolumes for Por t LockProcedures
Forportsystemvolumesandlockingprocedures,pleaserefertothepackaginginsert.
PowerLoc* Brand Safety Infusion Set** Gauge Size 19 Ga. 20 Ga. 22 Ga.
PowerLoc* Brand Safety Infusion Set** Gauge Color Cream Yellow Black
Maximum Recommended Flow Rate Setting 5mL/s 5mL/s 2mL/s
ACCESS SYSTEMS
ACCESS SYSTEMSInstructions For Use
Manufacturer:Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 USA801-522-5000Clinical Information Hotline: 800-443-3385www.bardaccess.comwww.portadvantage.comwww.veins4life.com
* Bard, Groshong, PowerLoc, PowerPort, the radiopaque symbol and “Your Port Access Advantage” are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
© 2012 C. R. Bard, Inc. All rights reserved.
0731485 1202R
7 8Hepar in LockProcedureFor Open-EndedCatheters
Tohelppreventclotformationandcatheterblockage,eachlumenoftheimplantedportswithopen-endedcathetersshouldbefilledwithsterileheparinizedsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,theheparinlockshouldbechangedatleastonceeveryfourweeks.Caution: Remember thatsomepatientsmaybehyper-sensitive toheparinor suffer fromheparin inducedthrombocytopenia (HIT).Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.
If the port catheter length is not known, the following are recommended flushing volumes for open-ended catheters,otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilesalineperlumen• 10mLsyringefilledwith5mLheparinizedsaline(100U/mL)perlumen
Note: Other concentrations of heparinized saline (10 to 1000U/mL) have been found to be effective.Determination of properconcentrationandvolumeshouldbebasedonpatient’smedicalcondition,laboratorytests,andpriorexperience.
Procedure:1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. After therapy completion, flushport per institutional protocol, then lockwith 5mL100U/mLheparinized saline, orwithport
system volume calculated on page 6. Closeclampwhileinjectinglast0.5mLoflocksolution. Warning: Alcohol should not be used to soak or declot polyurethane catheters because alcohol is known to degrade the
polyurethane catheters over time with repeated and prolonged exposure.
Sal ineLockProcedureFor Groshong*Catheters
Tohelppreventclotformationandcatheterblockage,implantedportswithGroshong*cathetersshouldbefilledwithsterilenormalsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,thesalinelockshouldbechangedbyflushingatleastonceeveryfourweeks.
If the port catheter length is not known, the following chart outlines the recommended flushing volumes for Groshong*catheters–otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilenormalsaline
Procedure:ReviewSitePreparationandAccessingImplantedPortsectionsbeforeproceedingwiththissection.
1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. Aftertherapycompletion,flushportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflushsolution.
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5mLheparinizedsalineevery4weeks(100U/mL)
AftereachinfusionofmedicationorTPN
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterbloodwithdrawl20 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterpowerinjectionofcontrast media
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5 mL sterile normal saline every4weeks
AftereachinfusionofmedicationorTPN 10 mL sterile normal saline
Afterbloodwithdrawl 20 mL sterile normal saline
Afterpowerinjectionofcontrast media 10 mL sterile normal saline
References
1. Jacobs, D. M. et. al., “Anatomical and Morphological Evaluation of Pacemaker Lead Compression”. PACE. 1993 Mar; 16(1):434-444.
2. Magney,J.E.et.al.,“AnatomicalMechanismsExplainingDamagetoPacemakerLeads,DefibrillatorLeadsandFailureofCentralVenousCathetersAdjacenttotheStemoclavicularJoint”.PACE.1993Mar;16(1):445-457.
3. Hinke, D,H.; Zandt-Stastny, D.A.; Goodman, L.R.; et.al. Pinch-off syndrome: A complication of implantable subclavianvenousaccessdevices.Radiology177:353-356,1990.
4. Ingle,Rebecca;Nace,Corinne.“VenousAccessDevices:CatheterPinch-offandFracture”.1993,BardAccessSystems,Inc.5. Camp-Sorrell,Dawn.“AccessDeviceGuidelines.”2ndEd.OncologyNursingSociety,2004.
Note:ThePowerPort*devicetestingincludedatleast36powerinjectioncycleswithaPowerLoc*BrandSafetyInfusionSet** and 11.8 cP viscosity contrast solution.
Fur ther Reading
• SeePowerPort*ImplantablePortNursingGuideand/orPowerPort*ImplantablePortCTGuideformoredetails.• BardAccessSystems,Inc.isproudtooffer“YourPortAccessAdvantage”*patienteducationmoduleforhelpingpatientsselecttheir
bestaccessoption.• www.powerportadvantage.com• www.portadvantage.com• www.veins4life.com
See Bard Access Systems’ Sales Representative for more information about any of these products. An issued orrevision date for these instructions is included for the user’s information. In the event two years have elapsedbetween this date and product use, the user should contact Bard Access Systems, Inc. to see if additional productinformationisavailable.
**e.g.,PowerLoc*,PowerLoc*Clear,PowerLoc*EZ,andPowerLoc*MAXSafetyInfusionSets
Reviseddate:December2011.
ThisdevicedoesnotcontainDEHP.
Thisproductandpackagingdonotcontainnaturalrubberlatex.
ContrastEnhancedComputedTomographyInformation
CTinjectorpressurelimitshouldbesetatamaximumof300psi.
CT
NotesNotes9 10
ACCESS SYSTEMS
ACCESS SYSTEMSInstructions For Use
Manufacturer:Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 USA801-522-5000Clinical Information Hotline: 800-443-3385www.bardaccess.comwww.portadvantage.comwww.veins4life.com
* Bard, Groshong, PowerLoc, PowerPort, the radiopaque symbol and “Your Port Access Advantage” are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
© 2012 C. R. Bard, Inc. All rights reserved.
0731485 1202R
7 8Hepar in LockProcedureFor Open-EndedCatheters
Tohelppreventclotformationandcatheterblockage,eachlumenoftheimplantedportswithopen-endedcathetersshouldbefilledwithsterileheparinizedsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,theheparinlockshouldbechangedatleastonceeveryfourweeks.Caution: Remember thatsomepatientsmaybehyper-sensitive toheparinor suffer fromheparin inducedthrombocytopenia (HIT).Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.
If the port catheter length is not known, the following are recommended flushing volumes for open-ended catheters,otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilesalineperlumen• 10mLsyringefilledwith5mLheparinizedsaline(100U/mL)perlumen
Note: Other concentrations of heparinized saline (10 to 1000U/mL) have been found to be effective.Determination of properconcentrationandvolumeshouldbebasedonpatient’smedicalcondition,laboratorytests,andpriorexperience.
Procedure:1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. After therapy completion, flushport per institutional protocol, then lockwith 5mL100U/mLheparinized saline, orwithport
system volume calculated on page 6. Closeclampwhileinjectinglast0.5mLoflocksolution. Warning: Alcohol should not be used to soak or declot polyurethane catheters because alcohol is known to degrade the
polyurethane catheters over time with repeated and prolonged exposure.
Sal ineLockProcedureFor Groshong*Catheters
Tohelppreventclotformationandcatheterblockage,implantedportswithGroshong*cathetersshouldbefilledwithsterilenormalsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,thesalinelockshouldbechangedbyflushingatleastonceeveryfourweeks.
If the port catheter length is not known, the following chart outlines the recommended flushing volumes for Groshong*catheters–otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilenormalsaline
Procedure:ReviewSitePreparationandAccessingImplantedPortsectionsbeforeproceedingwiththissection.
1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. Aftertherapycompletion,flushportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflushsolution.
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5mLheparinizedsalineevery4weeks(100U/mL)
AftereachinfusionofmedicationorTPN
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterbloodwithdrawl20 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterpowerinjectionofcontrast media
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5 mL sterile normal saline every4weeks
AftereachinfusionofmedicationorTPN 10 mL sterile normal saline
Afterbloodwithdrawl 20 mL sterile normal saline
Afterpowerinjectionofcontrast media 10 mL sterile normal saline
References
1. Jacobs, D. M. et. al., “Anatomical and Morphological Evaluation of Pacemaker Lead Compression”. PACE. 1993 Mar; 16(1):434-444.
2. Magney,J.E.et.al.,“AnatomicalMechanismsExplainingDamagetoPacemakerLeads,DefibrillatorLeadsandFailureofCentralVenousCathetersAdjacenttotheStemoclavicularJoint”.PACE.1993Mar;16(1):445-457.
3. Hinke, D,H.; Zandt-Stastny, D.A.; Goodman, L.R.; et.al. Pinch-off syndrome: A complication of implantable subclavianvenousaccessdevices.Radiology177:353-356,1990.
4. Ingle,Rebecca;Nace,Corinne.“VenousAccessDevices:CatheterPinch-offandFracture”.1993,BardAccessSystems,Inc.5. Camp-Sorrell,Dawn.“AccessDeviceGuidelines.”2ndEd.OncologyNursingSociety,2004.
Note:ThePowerPort*devicetestingincludedatleast36powerinjectioncycleswithaPowerLoc*BrandSafetyInfusionSet** and 11.8 cP viscosity contrast solution.
Fur ther Reading
• SeePowerPort*ImplantablePortNursingGuideand/orPowerPort*ImplantablePortCTGuideformoredetails.• BardAccessSystems,Inc.isproudtooffer“YourPortAccessAdvantage”*patienteducationmoduleforhelpingpatientsselecttheir
bestaccessoption.• www.powerportadvantage.com• www.portadvantage.com• www.veins4life.com
See Bard Access Systems’ Sales Representative for more information about any of these products. An issued orrevision date for these instructions is included for the user’s information. In the event two years have elapsedbetween this date and product use, the user should contact Bard Access Systems, Inc. to see if additional productinformationisavailable.
**e.g.,PowerLoc*,PowerLoc*Clear,PowerLoc*EZ,andPowerLoc*MAXSafetyInfusionSets
Reviseddate:December2011.
ThisdevicedoesnotcontainDEHP.
Thisproductandpackagingdonotcontainnaturalrubberlatex.
ContrastEnhancedComputedTomographyInformation
CTinjectorpressurelimitshouldbesetatamaximumof300psi.
CT
NotesNotes9 10
ACCESS SYSTEMS
ACCESS SYSTEMSInstructions For Use
Manufacturer:Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 USA801-522-5000Clinical Information Hotline: 800-443-3385www.bardaccess.comwww.portadvantage.comwww.veins4life.com
* Bard, Groshong, PowerLoc, PowerPort, the radiopaque symbol and “Your Port Access Advantage” are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
© 2012 C. R. Bard, Inc. All rights reserved.
0731485 1202R
7 8Hepar in LockProcedureFor Open-EndedCatheters
Tohelppreventclotformationandcatheterblockage,eachlumenoftheimplantedportswithopen-endedcathetersshouldbefilledwithsterileheparinizedsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,theheparinlockshouldbechangedatleastonceeveryfourweeks.Caution: Remember thatsomepatientsmaybehyper-sensitive toheparinor suffer fromheparin inducedthrombocytopenia (HIT).Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.
If the port catheter length is not known, the following are recommended flushing volumes for open-ended catheters,otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilesalineperlumen• 10mLsyringefilledwith5mLheparinizedsaline(100U/mL)perlumen
Note: Other concentrations of heparinized saline (10 to 1000U/mL) have been found to be effective.Determination of properconcentrationandvolumeshouldbebasedonpatient’smedicalcondition,laboratorytests,andpriorexperience.
Procedure:1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. After therapy completion, flushport per institutional protocol, then lockwith 5mL100U/mLheparinized saline, orwithport
system volume calculated on page 6. Closeclampwhileinjectinglast0.5mLoflocksolution. Warning: Alcohol should not be used to soak or declot polyurethane catheters because alcohol is known to degrade the
polyurethane catheters over time with repeated and prolonged exposure.
Sal ineLockProcedureFor Groshong*Catheters
Tohelppreventclotformationandcatheterblockage,implantedportswithGroshong*cathetersshouldbefilledwithsterilenormalsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,thesalinelockshouldbechangedbyflushingatleastonceeveryfourweeks.
If the port catheter length is not known, the following chart outlines the recommended flushing volumes for Groshong*catheters–otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilenormalsaline
Procedure:ReviewSitePreparationandAccessingImplantedPortsectionsbeforeproceedingwiththissection.
1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. Aftertherapycompletion,flushportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflushsolution.
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5mLheparinizedsalineevery4weeks(100U/mL)
AftereachinfusionofmedicationorTPN
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterbloodwithdrawl20 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterpowerinjectionofcontrast media
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5 mL sterile normal saline every4weeks
AftereachinfusionofmedicationorTPN 10 mL sterile normal saline
Afterbloodwithdrawl 20 mL sterile normal saline
Afterpowerinjectionofcontrast media 10 mL sterile normal saline
References
1. Jacobs, D. M. et. al., “Anatomical and Morphological Evaluation of Pacemaker Lead Compression”. PACE. 1993 Mar; 16(1):434-444.
2. Magney,J.E.et.al.,“AnatomicalMechanismsExplainingDamagetoPacemakerLeads,DefibrillatorLeadsandFailureofCentralVenousCathetersAdjacenttotheStemoclavicularJoint”.PACE.1993Mar;16(1):445-457.
3. Hinke, D,H.; Zandt-Stastny, D.A.; Goodman, L.R.; et.al. Pinch-off syndrome: A complication of implantable subclavianvenousaccessdevices.Radiology177:353-356,1990.
4. Ingle,Rebecca;Nace,Corinne.“VenousAccessDevices:CatheterPinch-offandFracture”.1993,BardAccessSystems,Inc.5. Camp-Sorrell,Dawn.“AccessDeviceGuidelines.”2ndEd.OncologyNursingSociety,2004.
Note:ThePowerPort*devicetestingincludedatleast36powerinjectioncycleswithaPowerLoc*BrandSafetyInfusionSet** and 11.8 cP viscosity contrast solution.
Fur ther Reading
• SeePowerPort*ImplantablePortNursingGuideand/orPowerPort*ImplantablePortCTGuideformoredetails.• BardAccessSystems,Inc.isproudtooffer“YourPortAccessAdvantage”*patienteducationmoduleforhelpingpatientsselecttheir
bestaccessoption.• www.powerportadvantage.com• www.portadvantage.com• www.veins4life.com
See Bard Access Systems’ Sales Representative for more information about any of these products. An issued orrevision date for these instructions is included for the user’s information. In the event two years have elapsedbetween this date and product use, the user should contact Bard Access Systems, Inc. to see if additional productinformationisavailable.
**e.g.,PowerLoc*,PowerLoc*Clear,PowerLoc*EZ,andPowerLoc*MAXSafetyInfusionSets
Reviseddate:December2011.
ThisdevicedoesnotcontainDEHP.
Thisproductandpackagingdonotcontainnaturalrubberlatex.
ContrastEnhancedComputedTomographyInformation
CTinjectorpressurelimitshouldbesetatamaximumof300psi.
CT
NotesNotes9 10
ACCESS SYSTEMS
ACCESS SYSTEMSInstructions For Use
Manufacturer:Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 USA801-522-5000Clinical Information Hotline: 800-443-3385www.bardaccess.comwww.portadvantage.comwww.veins4life.com
* Bard, Groshong, PowerLoc, PowerPort, the radiopaque symbol and “Your Port Access Advantage” are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
© 2012 C. R. Bard, Inc. All rights reserved.
0731485 1202R
7 8Hepar in LockProcedureFor Open-EndedCatheters
Tohelppreventclotformationandcatheterblockage,eachlumenoftheimplantedportswithopen-endedcathetersshouldbefilledwithsterileheparinizedsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,theheparinlockshouldbechangedatleastonceeveryfourweeks.Caution: Remember thatsomepatientsmaybehyper-sensitive toheparinor suffer fromheparin inducedthrombocytopenia (HIT).Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.
If the port catheter length is not known, the following are recommended flushing volumes for open-ended catheters,otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilesalineperlumen• 10mLsyringefilledwith5mLheparinizedsaline(100U/mL)perlumen
Note: Other concentrations of heparinized saline (10 to 1000U/mL) have been found to be effective.Determination of properconcentrationandvolumeshouldbebasedonpatient’smedicalcondition,laboratorytests,andpriorexperience.
Procedure:1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. After therapy completion, flushport per institutional protocol, then lockwith 5mL100U/mLheparinized saline, orwithport
system volume calculated on page 6. Closeclampwhileinjectinglast0.5mLoflocksolution. Warning: Alcohol should not be used to soak or declot polyurethane catheters because alcohol is known to degrade the
polyurethane catheters over time with repeated and prolonged exposure.
Sal ineLockProcedureFor Groshong*Catheters
Tohelppreventclotformationandcatheterblockage,implantedportswithGroshong*cathetersshouldbefilledwithsterilenormalsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,thesalinelockshouldbechangedbyflushingatleastonceeveryfourweeks.
If the port catheter length is not known, the following chart outlines the recommended flushing volumes for Groshong*catheters–otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilenormalsaline
Procedure:ReviewSitePreparationandAccessingImplantedPortsectionsbeforeproceedingwiththissection.
1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. Aftertherapycompletion,flushportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflushsolution.
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5mLheparinizedsalineevery4weeks(100U/mL)
AftereachinfusionofmedicationorTPN
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterbloodwithdrawl20 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterpowerinjectionofcontrast media
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5 mL sterile normal saline every4weeks
AftereachinfusionofmedicationorTPN 10 mL sterile normal saline
Afterbloodwithdrawl 20 mL sterile normal saline
Afterpowerinjectionofcontrast media 10 mL sterile normal saline
References
1. Jacobs, D. M. et. al., “Anatomical and Morphological Evaluation of Pacemaker Lead Compression”. PACE. 1993 Mar; 16(1):434-444.
2. Magney,J.E.et.al.,“AnatomicalMechanismsExplainingDamagetoPacemakerLeads,DefibrillatorLeadsandFailureofCentralVenousCathetersAdjacenttotheStemoclavicularJoint”.PACE.1993Mar;16(1):445-457.
3. Hinke, D,H.; Zandt-Stastny, D.A.; Goodman, L.R.; et.al. Pinch-off syndrome: A complication of implantable subclavianvenousaccessdevices.Radiology177:353-356,1990.
4. Ingle,Rebecca;Nace,Corinne.“VenousAccessDevices:CatheterPinch-offandFracture”.1993,BardAccessSystems,Inc.5. Camp-Sorrell,Dawn.“AccessDeviceGuidelines.”2ndEd.OncologyNursingSociety,2004.
Note:ThePowerPort*devicetestingincludedatleast36powerinjectioncycleswithaPowerLoc*BrandSafetyInfusionSet** and 11.8 cP viscosity contrast solution.
Fur ther Reading
• SeePowerPort*ImplantablePortNursingGuideand/orPowerPort*ImplantablePortCTGuideformoredetails.• BardAccessSystems,Inc.isproudtooffer“YourPortAccessAdvantage”*patienteducationmoduleforhelpingpatientsselecttheir
bestaccessoption.• www.powerportadvantage.com• www.portadvantage.com• www.veins4life.com
See Bard Access Systems’ Sales Representative for more information about any of these products. An issued orrevision date for these instructions is included for the user’s information. In the event two years have elapsedbetween this date and product use, the user should contact Bard Access Systems, Inc. to see if additional productinformationisavailable.
**e.g.,PowerLoc*,PowerLoc*Clear,PowerLoc*EZ,andPowerLoc*MAXSafetyInfusionSets
Reviseddate:December2011.
ThisdevicedoesnotcontainDEHP.
Thisproductandpackagingdonotcontainnaturalrubberlatex.
ContrastEnhancedComputedTomographyInformation
CTinjectorpressurelimitshouldbesetatamaximumof300psi.
CT
NotesNotes9 10
ACCESS SYSTEMS
ACCESS SYSTEMSInstructions For Use
Manufacturer:Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 USA801-522-5000Clinical Information Hotline: 800-443-3385www.bardaccess.comwww.portadvantage.comwww.veins4life.com
* Bard, Groshong, PowerLoc, PowerPort, the radiopaque symbol and “Your Port Access Advantage” are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
© 2012 C. R. Bard, Inc. All rights reserved.
0731485 1202R
7 8Hepar in LockProcedureFor Open-EndedCatheters
Tohelppreventclotformationandcatheterblockage,eachlumenoftheimplantedportswithopen-endedcathetersshouldbefilledwithsterileheparinizedsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,theheparinlockshouldbechangedatleastonceeveryfourweeks.Caution: Remember thatsomepatientsmaybehyper-sensitive toheparinor suffer fromheparin inducedthrombocytopenia (HIT).Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.
If the port catheter length is not known, the following are recommended flushing volumes for open-ended catheters,otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilesalineperlumen• 10mLsyringefilledwith5mLheparinizedsaline(100U/mL)perlumen
Note: Other concentrations of heparinized saline (10 to 1000U/mL) have been found to be effective.Determination of properconcentrationandvolumeshouldbebasedonpatient’smedicalcondition,laboratorytests,andpriorexperience.
Procedure:1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. After therapy completion, flushport per institutional protocol, then lockwith 5mL100U/mLheparinized saline, orwithport
system volume calculated on page 6. Closeclampwhileinjectinglast0.5mLoflocksolution. Warning: Alcohol should not be used to soak or declot polyurethane catheters because alcohol is known to degrade the
polyurethane catheters over time with repeated and prolonged exposure.
Sal ineLockProcedureFor Groshong*Catheters
Tohelppreventclotformationandcatheterblockage,implantedportswithGroshong*cathetersshouldbefilledwithsterilenormalsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,thesalinelockshouldbechangedbyflushingatleastonceeveryfourweeks.
If the port catheter length is not known, the following chart outlines the recommended flushing volumes for Groshong*catheters–otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilenormalsaline
Procedure:ReviewSitePreparationandAccessingImplantedPortsectionsbeforeproceedingwiththissection.
1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. Aftertherapycompletion,flushportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflushsolution.
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5mLheparinizedsalineevery4weeks(100U/mL)
AftereachinfusionofmedicationorTPN
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterbloodwithdrawl20 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterpowerinjectionofcontrast media
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5 mL sterile normal saline every4weeks
AftereachinfusionofmedicationorTPN 10 mL sterile normal saline
Afterbloodwithdrawl 20 mL sterile normal saline
Afterpowerinjectionofcontrast media 10 mL sterile normal saline
References
1. Jacobs, D. M. et. al., “Anatomical and Morphological Evaluation of Pacemaker Lead Compression”. PACE. 1993 Mar; 16(1):434-444.
2. Magney,J.E.et.al.,“AnatomicalMechanismsExplainingDamagetoPacemakerLeads,DefibrillatorLeadsandFailureofCentralVenousCathetersAdjacenttotheStemoclavicularJoint”.PACE.1993Mar;16(1):445-457.
3. Hinke, D,H.; Zandt-Stastny, D.A.; Goodman, L.R.; et.al. Pinch-off syndrome: A complication of implantable subclavianvenousaccessdevices.Radiology177:353-356,1990.
4. Ingle,Rebecca;Nace,Corinne.“VenousAccessDevices:CatheterPinch-offandFracture”.1993,BardAccessSystems,Inc.5. Camp-Sorrell,Dawn.“AccessDeviceGuidelines.”2ndEd.OncologyNursingSociety,2004.
Note:ThePowerPort*devicetestingincludedatleast36powerinjectioncycleswithaPowerLoc*BrandSafetyInfusionSet** and 11.8 cP viscosity contrast solution.
Fur ther Reading
• SeePowerPort*ImplantablePortNursingGuideand/orPowerPort*ImplantablePortCTGuideformoredetails.• BardAccessSystems,Inc.isproudtooffer“YourPortAccessAdvantage”*patienteducationmoduleforhelpingpatientsselecttheir
bestaccessoption.• www.powerportadvantage.com• www.portadvantage.com• www.veins4life.com
See Bard Access Systems’ Sales Representative for more information about any of these products. An issued orrevision date for these instructions is included for the user’s information. In the event two years have elapsedbetween this date and product use, the user should contact Bard Access Systems, Inc. to see if additional productinformationisavailable.
**e.g.,PowerLoc*,PowerLoc*Clear,PowerLoc*EZ,andPowerLoc*MAXSafetyInfusionSets
Reviseddate:December2011.
ThisdevicedoesnotcontainDEHP.
Thisproductandpackagingdonotcontainnaturalrubberlatex.
ContrastEnhancedComputedTomographyInformation
CTinjectorpressurelimitshouldbesetatamaximumof300psi.
CT
NotesNotes9 10
ACCESS SYSTEMS
ACCESS SYSTEMSInstructions For Use
Manufacturer:Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 USA801-522-5000Clinical Information Hotline: 800-443-3385www.bardaccess.comwww.portadvantage.comwww.veins4life.com
* Bard, Groshong, PowerLoc, PowerPort, the radiopaque symbol and “Your Port Access Advantage” are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.
© 2012 C. R. Bard, Inc. All rights reserved.
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7 8Hepar in LockProcedureFor Open-EndedCatheters
Tohelppreventclotformationandcatheterblockage,eachlumenoftheimplantedportswithopen-endedcathetersshouldbefilledwithsterileheparinizedsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,theheparinlockshouldbechangedatleastonceeveryfourweeks.Caution: Remember thatsomepatientsmaybehyper-sensitive toheparinor suffer fromheparin inducedthrombocytopenia (HIT).Thesepatientsmustnothavetheirportlockedwithheparinizedsaline.
If the port catheter length is not known, the following are recommended flushing volumes for open-ended catheters,otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilesalineperlumen• 10mLsyringefilledwith5mLheparinizedsaline(100U/mL)perlumen
Note: Other concentrations of heparinized saline (10 to 1000U/mL) have been found to be effective.Determination of properconcentrationandvolumeshouldbebasedonpatient’smedicalcondition,laboratorytests,andpriorexperience.
Procedure:1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. After therapy completion, flushport per institutional protocol, then lockwith 5mL100U/mLheparinized saline, orwithport
system volume calculated on page 6. Closeclampwhileinjectinglast0.5mLoflocksolution. Warning: Alcohol should not be used to soak or declot polyurethane catheters because alcohol is known to degrade the
polyurethane catheters over time with repeated and prolonged exposure.
Sal ineLockProcedureFor Groshong*Catheters
Tohelppreventclotformationandcatheterblockage,implantedportswithGroshong*cathetersshouldbefilledwithsterilenormalsalineaftereachuse.Iftheportremainsunusedforlongperiodsoftime,thesalinelockshouldbechangedbyflushingatleastonceeveryfourweeks.
If the port catheter length is not known, the following chart outlines the recommended flushing volumes for Groshong*catheters–otherwisefollow institutional protocol.
Equipment:• Non-coringneedle• 10mLsyringefilledwithsterilenormalsaline
Procedure:ReviewSitePreparationandAccessingImplantedPortsectionsbeforeproceedingwiththissection.
1. Explainproceduretopatientandprepareinjectionsite.2. Attacha10mLsyringefilledwithsterilenormalsalinetoneedle.3. Aseptically locate and access port.4. Aftertherapycompletion,flushportperinstitutionalprotocol.Closeclampwhileinjectinglast0.5mLofflushsolution.
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5mLheparinizedsalineevery4weeks(100U/mL)
AftereachinfusionofmedicationorTPN
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterbloodwithdrawl20 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Afterpowerinjectionofcontrast media
10 mL sterile normal saline then5mLheparinizedsaline
(100U/mL)
Flushing and Locking Volumes (each lumen)Procedure Volume
Whenportnotinuse 5 mL sterile normal saline every4weeks
AftereachinfusionofmedicationorTPN 10 mL sterile normal saline
Afterbloodwithdrawl 20 mL sterile normal saline
Afterpowerinjectionofcontrast media 10 mL sterile normal saline
References
1. Jacobs, D. M. et. al., “Anatomical and Morphological Evaluation of Pacemaker Lead Compression”. PACE. 1993 Mar; 16(1):434-444.
2. Magney,J.E.et.al.,“AnatomicalMechanismsExplainingDamagetoPacemakerLeads,DefibrillatorLeadsandFailureofCentralVenousCathetersAdjacenttotheStemoclavicularJoint”.PACE.1993Mar;16(1):445-457.
3. Hinke, D,H.; Zandt-Stastny, D.A.; Goodman, L.R.; et.al. Pinch-off syndrome: A complication of implantable subclavianvenousaccessdevices.Radiology177:353-356,1990.
4. Ingle,Rebecca;Nace,Corinne.“VenousAccessDevices:CatheterPinch-offandFracture”.1993,BardAccessSystems,Inc.5. Camp-Sorrell,Dawn.“AccessDeviceGuidelines.”2ndEd.OncologyNursingSociety,2004.
Note:ThePowerPort*devicetestingincludedatleast36powerinjectioncycleswithaPowerLoc*BrandSafetyInfusionSet** and 11.8 cP viscosity contrast solution.
Fur ther Reading
• SeePowerPort*ImplantablePortNursingGuideand/orPowerPort*ImplantablePortCTGuideformoredetails.• BardAccessSystems,Inc.isproudtooffer“YourPortAccessAdvantage”*patienteducationmoduleforhelpingpatientsselecttheir
bestaccessoption.• www.powerportadvantage.com• www.portadvantage.com• www.veins4life.com
See Bard Access Systems’ Sales Representative for more information about any of these products. An issued orrevision date for these instructions is included for the user’s information. In the event two years have elapsedbetween this date and product use, the user should contact Bard Access Systems, Inc. to see if additional productinformationisavailable.
**e.g.,PowerLoc*,PowerLoc*Clear,PowerLoc*EZ,andPowerLoc*MAXSafetyInfusionSets
Reviseddate:December2011.
ThisdevicedoesnotcontainDEHP.
Thisproductandpackagingdonotcontainnaturalrubberlatex.
ContrastEnhancedComputedTomographyInformation
CTinjectorpressurelimitshouldbesetatamaximumof300psi.
CT
NotesNotes9 10