Bard DUET Operating instructions

CARE AND MAINTENANCE

The care and maintenance of the catheter requires well trained, skilled personnel following a detailed protocol. The protocol should include a

directive that the catheter is not to be used for any purpose other than the prescribed therapy.

ACCESSING CATHETER, CAP CHANGES, DRESSING CHANGES

• Experiencedpersonnel

• Useaseptictechnique

 •Properhandhygiene

 •Cleanglovestoaccesscatheterandremovedressingandsterileglovesfordressingchanges

 •Surgicalmask(1forthepatientand1forthehealthcareprofessional)

• Catheterexitsiteshouldbeexaminedforsignsofinfectionanddressingsshouldbechangedateachdialysistreatment.

• CatheterLuer-lockConnectorswithendcapsattachedshouldbesoakedfor3to5minutesinpovidoneiodineandthenallowedtodry

before separation.

• Carefullyremovethedressingandinspecttheexitsiteforinammation,swellingandtenderness.Notifyphysicianimmediatelyifsignsof

infection are present.

EXIT SITE CLEANING

• Useaseptictechnique(asoutlinedabove)

• Cleantheexitsiteateachdialysistreatmentwithchlorhexidinegluconateunlesscontraindicated.Applyantisepticpermanufacturer’s

recommendations.Allowtoairdrycompletely.

• Covertheexitsitewithsterile,transparent,semipermeabledressingorperhospitalprotocol.

RECOMMENDED CLEANING SOLUTIONS

Catheter Luer-lock Connectors/End Caps:

•Povidoneiodine(allowconnectors/endcapstosoakfor3to5

minutes)

WARNING:Alcoholshouldnotbeusedtolock,soakordeclotpolyure-

thaneDialysisCathetersbecausealcoholisknowntodegradepoly-

urethanecathetersovertimewithrepeatedandprolongedexposure.

Hand cleaner solutions are not intended to be used for disinfecting

ourdialysiscatheterLuer-lockConnectors.

Exit Site:

•Chlorhexidinegluconate2%solution(preferred)

3,7,8,9,10

•Chlorhexidinegluconate4%solution

•Diluteaqueoussodiumhypochlorite

•0.55%sodiumhypochloritesolution

•Povidoneiodine

•Hydrogenperoxide

•Chlorhexidinepatches

•Bacitracinzincointmentsinpetrolatumbases

WARNING:AcetoneandPEG-containingointmentscancausefailure

of this device and should not be used with polyurethane catheters.

Chlorhexidinepatchesorbacitracinzincointments(e.g.Polysporin*

ointment)arethepreferredalternative.

POST DIALYSIS

Useaseptictechnique(asoutlinedabove).

1. Flusharterialandvenouslumenswithaminimumof10mLofsterilesaline.

WARNING: Toavoiddamagetovesselsandviscus,infusionpressuresmustnotexceed25psi(172kPa).Theuseofa10mLorlargersyringeis

recommended because smaller syringes generate more pressure than larger syringes.

2. Injectheparinsolutionintoboththearterialandvenouslumensofthecatheter.Theappropriateheparinsolutionconcentrationandushing

frequencyshouldbebasedonhospitalprotocol.Heparinsolutionof1,000to5,000units/mLhasbeenfoundtobeeectiveformaintaining

thepatencyofhemodialysisandapheresiscatheters.Wheninjectingheparinsolution,injectquicklyandclampextensionwhileunderposi-

tivepressure.Heparinsolutionvolumetolockeachlumenmustbeequaltotheprimingvolumeofeachlumen.Primingvolumesaremarked

on each lumen.

3. CleancatheterLuer-lockconnectorsperhospitalprotocol.Attachsterileendcapstoboththearterialandthevenousclampingextension

pieces.

WARNING: Topreventsystemicheparinizationofthepatient,theheparinsolutionmustbeaspiratedoutofbothlumensimmediatelyprior

tousingthecatheter.Inmostinstances,nofurtherheparinsolutioninjectionisnecessaryfor48-72hours,providedthecatheterhasnot

beenaspiratedorushed.

CATHETER REMOVAL

Evaluatethecatheterroutinelyandpromptlyremoveanynonessentialcatheter

perphysician’sorders.Afterremovingthecatheter,apply

manualpressuretothepuncturesitefor10-15minutesuntilnosignsofbleedingarepresent.Thenapplysterile,transparent,semipermeable

dressingordressingperhospitalprotocolforaminimumof8hours.Followhospitalprotocolregardingbedrestaftercatheterremoval.

DISPOSAL

Afteruse,thecathetersandaccessoriesmaybeapotentialbiohazard.Handleanddisposeofinaccordancewithacceptedmedical

practice and all applicable laws and regulations.

TROUBLESHOOTING

PATIENT WITH FEVER

Patientwithfeverandchillsfollowingtheproceduremaybeindicativeofcatheter-relatedsepsis.Ifthisresults,removalofthecathetermaybe

indicated.

INSUFFICIENT FLOW

Excessiveforcemustnotbeusedtoushanobstructedlumen.Insuﬃcientbloodowmaybecausedbyanoccludedtipresultingfromaclot

orbycontactingthewallofthevein.Ifmanipulationofthecatheterorreversingarterialandvenouslinesdoesnothelp,thenthephysicianmay

attempttodissolvetheclotwithathrombolyticagent(e.g.TPA,Catho*Activase*thrombolytic).Physiciandiscretionadvised.

CATHETER EXCHANGE

Donotroutinelyreplacedialysiscatheterstopreventcatheter-relatedinfections

.Itmaybecomenecessarytoexchangetheindwellingcatheter

duetoapersistentriseinpressuresordecreaseofowrateswhichcannotberectiedthroughtroubleshooting.Catheterexchangesshould

be performed under strict aseptic conditions in which the physician should wear a cap, mask, sterile gown, sterile gloves, and use a large sterile

drape to cover the patient.

REFERENCES

1. Aitken,D.R.andMinton,J.P.“ThePinch-OSign:AWarningofImpendingProblemswithPermanentSubclavianCatheters”,AmericanJournal

ofSurgery,Vol.148,Nov.1984,pp.633-638.

2. Mickley,V.,“Centralvenouscatheters:manyquestions:fewanswers”,NephrolDialTransplant,(2002)17:1368-1373.

3. NationalKidneyFoundationK/DOQIGUIDELINES2006.

4. Sulek,CA.,Blas,ML.,Lobato,EB,“Arandomizedstudyofleftversusrightinternaljugularveincannulationinadults.”JClinAnesth.2000

Mar;12(2):142-5

5. Tan,P.L.,Gibson,M.,“CentralVenousCatheters:theroleofradiology”,ClinRad.2006,61:13-22

6. Octavio,Bella,Colemenares,Garcia,andFlores;“RightVersesLeftInternalVeinCatheterizationforHemodialysis:ComplicationsandImpact

onIpsilateralAccessCreation”;ArticalOrgans;2004,28(8):728-733.

7. TheInstituteforHealthcareImprovement,“How-to-Guide:PreventCentralLineInfections,”2006.

8. TheJointCommissionHospitalAccreditationOrganization,NationalPatientSafetyGoals,2009.

9. CenterforDiseaseControlandPrevention,“GuidelinesforthePreventionofIntravascularCatheter-RelatedInfections,”MorbidityandMortal-

ityWeeklyReport,Aug.9,2002,51(RR-10),1-32.

10.TheSocietyforHealthcareEpidemiologyofAmerica,“StrategiestoPreventCentralLine-AssociatedBloodstreamInfectionsinAcuteCare

Hospitals,”InfectionControlandHospitalEpidemiology,Oct.2008,29(S1):S22-S30.

Otherreferencesavailableuponrequest

MRConditional

Non-clinicaltestinghasdemonstratedthedeviceisMRConditional.Itcanbescannedsafelyunder:

• staticmagneticeldof3Teslaorless

• spatialgradienteldof360Gauss/cmorless

• maximumspecicabsorptionrate(SAR)or4W/kgfor15minutesofscanning.

• Innon-clinicaltesting,thedeviceproducedatemperatureriseoflessthan1.4°Catamaximumspecicabsorptionrate

 (SAR)of4W/kgfor15minutesofMRscanningina3TeslaSiemensTriowithsoftwareversionB15.

ForMinimalImageArtifact

• MRimagequalitymaybecompromisediftheareaofinterestisinthesameareaorrelativelyclosetothepositionoftheextensionlegs.

Therefore,itmaybenecessarytooptimizeMRimagingparametersforpresenceofthemetallicportionoftheextensionlegsormoveexten-

sion legs away from area of interest.

Anissuedorrevisiondatefortheseinstructionsisincludedfortheusersinformation.Intheeventtwoyearshaveelapsedbetweenthisdateand

product use, the user should contact Bard Access Systems, Inc. to see if additional product information is available.

Revisiondate:March2010.

*Bard, Duet and StatLockaretrademarksand/orregisteredtrademarksofC.R.Bard,Inc.

Allothertrademarksarethepropertyoftheirrespectiveowners.

©2010C. R. Bard, Inc. Allrightsreserved.

Bard Access Systems, Inc.

605North5600West

SaltLakeCity,UT84116U.S.A.

1-801-522-5000

CustomerService:800-545-0890

ClinicalInformation:800-443-3385

www.bardaccess.com

InstructionsForUse

For

Duet*

Long-TermHemodialysisCatheterSystem

Access Systems

DESCRIPTION

The Duet* Long-Term Hemodialysis Catheter System is made of Carbothane* radiopaque polyurethane. The catheter system is comprised of

twosingle10Frenchlumensthatallowforowratesashighas400mL/min.Eachcathetercomeswithanextensionlegandaretentioncufor

tissueingrowthtoanchorthecatheter.Thearterial(red)andvenous(blue)lumensaredistinguishedbythecolorcodingoftheprintingonthe

catheterandthecolor-codedLuer-lockconnector.

STERILIZATIONBYETHYLENEOXIDE.

Sterile,

Non-Pyrogenic

Unless Package is

Damaged or Opened.

Do not use if package is damaged

MRConditional 

Non-pyrogenic

Sterilize

This product does

notcontainDEHP

This product and packaging do not

containnaturalrubberlatex.

INDICATIONS FOR USE

The Duet*Long-termHemodialysisCatheterSystemisindicatedforuseinattainingshort-termorlong-termvascularaccessforhemodialysis,

hemoperfusion,orapheresistherapy.Thecathetersmaybeinsertedpercutaneouslyintotheinternaljugularvein,subclavian,orexternaljugular

vein.

CONTRAINDICATION

Thisdeviceiscontraindicatedforpatientsexhibitingsevere,uncontrolledthrombocytopeniaorcoagulopathy.

WARNINGS

First Rib

Subclavian Vein

Clavicle

Vertebra

Internal Jugular Vei

Superior Vena Cava

Sternum

Pinch-off Area

Infraclavicular Fossa

Axillary Vein

WARNING:Ifthesubclavianveinisused,percutaneousinsertionofthecatheter

shouldbemadeintotheaxillary-subclavianveinatthejunctionoftheouterand

mid-thirdsoftheclaviclelateraltothethoracicoutlet.Thecathetershouldnotbe

insertedintothesubclavianveinmediallybecausesuchplacementcanleadtocom-

pressionofthecatheterbetweentherstribandclavicleandcanleadtodamageor

fractureandembolizationofthecatheter.

Fluoroscopicorradiographicconrmation

of catheter tip placement should be helpful in demonstrating that the catheter is not

beingpinchedbytherstribandclavicle.

•Useofthesubclavianveinforcatheterplacementmayresultin

subclavianveinstenosis.Subclavianveinstenosismaypreventfuture

useoftheipsilateralextremityforpermanentaccess.Useofthejugular

vein is preferred.

•Alcoholoralcohol-containingantiseptics(suchaschlorhexidine)maybeusedto

cleanthecatheter/skinsite;however,careshouldbetakentoavoidprolongedorexcessivecontactwiththesolutions(s).

• AcetoneandPEG-containingointmentscancausefailureofthisdeviceandshouldnotbeusedwithpolyurethanecatheters.Chlorhexidine

patchesorbacitracinzincointments(e.g.,Polysporin* ointment)arethepreferredalternative.

• FollowUniversalPrecautionswheninsertingandmaintainingthisdevice.

• Cardiacarrhythmiasmayresultiftheguidewireisallowedtopassintotherightatrium.

• Donottunnelthroughmuscle.

• Clampingthecatheterrepeatedlyinthesamespotcouldweakenthetubing.Changethepositionoftheextensionclampsregularlyto

prolongthelifeoftheextensiontubing.AvoidclampingnearorontheLuer-lockconnectors,asthismaycausetubingfatigueandpossible

disconnection.Extensiontubingmaydeveloptearsorcutsifsubjectedtoexcessivepullingorcontactwithroughedges.Examinetubingfor

damage both prior to and after each treatment.

• Cathetersshouldbeimplantedcarefullytoavoidanysharporacuteangleswhichcouldcompromisetheopeningofthecatheterlumens.

• Topreventairembolismand/orbloodloss,placethumbovertheexposedoriceofthesheathintroducer.

• Toavoiddamagetovesselsandviscus,infusionpressuresshouldnotexceed25psi(172kPa).Theuseofa10mLorlargersyringeisrecom-

mended because smaller syringes generate more pressure than larger syringes. Note:Athreepound(13.3Newton)forceontheplungerof

a3mLsyringegeneratespressureinexcessof30psi(206kPa)whereasthesamethreepound(13.3Newton)forceontheplungerofa10mL

syringegenerateslessthan15psi(103kPa)ofpressure.

• AccessoriesandcomponentsusedinconjunctionwiththiscathetershouldincorporateLuer-lockconnectors.

• Theheparinsolutionmustbeaspiratedoutofbothlumensimmediatelypriortousingthecathetertopreventsystemicheparinizationofthe

patient.

• Failuretoclampextensionswhennotinusemayleadtoairembolism,bleeding,andpossibleocclusions.

• Intherareeventofaleak,thecathetershouldbeclampedimmediately.Necessaryremedialactionmustbetakenpriortoresumingdialysis,

hemoperfusion, or apheresis procedure.

• Donotresterilizethecatheterorcomponentsbyanymethod.Themanufacturerwillnotbeliableforanydamagescausedbyreuseofthe

catheter or accessories.

• Cannulationoftheleftinternaljugularveinisreportedlyassociatedwithahigherincidenceofcomplicationscomparedtocatheterplace-

mentintherightinternaljugularvein.

• Donotadvanceguidewireorcatheterifunusualresistanceisencountered.

• TheblueCompressionSleeveisanecessarycomponentoftheExtensionLegAssembly.AlwaysvisuallyconrmthattheCompressionSleeve

remainsintheFemaleConnectorduringassembly.

• Alcoholshouldnotbeusedtolock,soakordeclotpolyurethaneDialysisCathetersbecausealcoholisknowntodegradepolyurethane

cathetersovertimewithrepeatedandprolongedexposure.

• Reusemaycreateariskofpatientinfectionofuserinfection,compromisethestructuralintegrityofthedevice,leadtodevicefailureand/or

leadtoinjury,illnessordeathofthepatient.

• TheSlideClamp,ThumbClamp,andPlugareprovidedforuseduringcatheterplacementonly.Donotreuse.

• Notintendedforpediatricorneonataluse.

• IntendedforSingleUse.DONOTREUSE.Reuseand/orrepackagingmaycreateariskofpatientoruserinfection,compromisethestructural

integrityand/oressentialmaterialanddesigncharacteristicsofthedevice,whichmayleadtodevicefailure,and/orleadtoinjury,illnessor

death of the patient.

CAUTIONS

• Repeatedovertighteningofbloodlines,syringesandcapswillreduceLuer-lockconnectorlifeandcouldleadtopotentialconnectorfailure.

Incaseofdamage,clampthecatheterbetweenthepatientandthedamagedareawithasmooth-edged,atraumaticclamp.

• Sterileandnon-pyrogeniconlyifpackagingisnotopened,damagedorbroken.

• Readtheinstructionsforusecarefullybeforeusingthisdevice.

• Federal(USA)lawrestrictsthisdevicetosalebyorontheorderofaphysician.

• CareshouldbetakenNOTtoforcethedilatorsheathintroducerintothevesselduringinsertionasvesseldamageincludingperforationcould

result.

• Leftsidedcatheterplacementmayprovideuniquechallengesduetotherightanglesformedbytheinnominateveinandattheleftbrachio-

cephalicjunctionwiththeSVC.

2,5

• Ensurethatthesheathintroducerisonlytornexternally.Cathetermayneedtobefurtherpushedintothevesselassheathintroduceristorn.

• Foroptimalproductperformance,donotinsertanyportionofthecuintothevein.

• Careshouldbetakennottoadvancethesplitsheathtoofarintovesselasapotentialkinkwouldcreateanimpassetothecatheter.

• PlacementandcareoftheDuet*Cathetersshouldbeperformedbypersonsknowledgeableoftherisksinvolvedandqualiedintheproce-

dures.

• Donotcreateasharpbendincathetertunnelasthismaycausekinkingandimpactow.

• Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandguidewireasaunittopreventtheneedlefrom

damaging or shearing the guidewire.

• Cuttingthecatheteranywherebutthepre-printedmarkswillresultintheinabilitytoreadthecatheterlengthandprimingvolumes.

• Cathetertipsmustbestaggeredby4cmtominimizerecirculation.

• BeforeattemptingtheinsertionofDuet*Catheters,ensurethatyouarefamiliarwiththefollowingcomplicationsandtheiremergencytreat-

ment should any of them occur.

POSSIBLE COMPLICATIONS

These and other complications are well documented in medical literature and should be carefully considered before placing the catheter.

Theuseofanindwellingcentralvenouscatheterprovidesanimportantmeansofvenousaccessforcriticallyillpatients;however,thepotential

existsforseriouscomplicationsincludingthefollowing:

• AirEmbolism

• Bleeding

• BrachialPlexusInjury

• CardiacArrhythmia

• CatheterorCuErosionthroughtheSkin

• CatheterEmbolism

• CatheterOcclusion

• CatheterOcclusion,DamageorBreakage

duetoCompressionbetweentheClavicle

andFirstRiborKinking

• Catheter-relatedSepsis

• CardiacTamponade

• Endocarditis

• ExitSiteInfection

• ExitSiteNecrosis

• Extravasation

• FibrinSheathFormation

• Hemothorax

• Hemotoma

• Hydrothorax

• Inammation,Necrosisorscarringofskin

over implant area

• IntoleranceReactiontoImplantedDevice

• LacerationofVesselsorViscus

• Mediastinalwidening

• PerforationofVesselsorViscus

• Pneumothorax

• RetroperitonealBleed

• RisksNormallyAssociatedwithLocaland

GeneralAnesthesia,Surgery,andPost-

OperativeRecovery

• ThoracicDuctInjury

• Thromboembolism

• VenousThrombosis

• VentricularThrombosis

• VesselErosion

0724304/1003R

F. Assembly of Catheter and Extensions

31.(Asapplicable)usingascalpelorscissors,cutcathetersquarelyatdesiredpre-printedmarktoproduceaclean,smoothsurface(Figure5).

Ensureatleast6cmofcatheterextendfromexitsitetoallowforconnection.

35 cm/2.0ml

35 cm/x.xml

40 cm/2.2ml

45 cm/2.4ml

Figure 5

CAUTION: Cuttingthecatheteranywherebutthepre-printedmarkswillresultintheinabilitytoreadthecatheterlengthandpriming

volumes.

Figure 6

Female Connector

Figure 7

Blue

Compression

Sleeve

Female Connector

WARNING: TheblueCompressionSleeveisanecessarycomponentoftheExtensionLegAssem-

bly.AlwaysvisuallyconrmthattheCompressionSleeveremainsintheFemaleConnectorduring

assembly(Figure7).

32.HoldunclampedExtensionLegAssemblyandattachsterile10mLsyringeandprimewithnormalsterilesaline,leavingsyringeattached

(Figure8).WARNING: Toavoiddamagetovesselsandviscus,infusionpressuresshouldnotexceed25psi(172kPa).Theuseofa10mLor

larger syringe is recommended because smaller syringes generate more pressure than larger syringes.

Figure 8

33.With catheters cut per Step 31, slip Female

Connector over catheter visually conrming

blue Compression Sleeve remains inside

Female Connector (Figure9).

Note:Attachtheappropriatecolor-coded

(blue-venous,red-arterial)ExtensionLegassembly.

Figure 9

34.SlideproximalendofcatheterovermetalcannulaontheExtensionLegBody,ensuringthatcatheterisattachedentirelengthofmetal

cannulaandnometalisvisible(Figure10).

Figure 10

35.SlideFemaleConnectortowardsExtensionLegBodyandassemblethetwotogetheruntilthetwoarefullyseated(Figure11).

WARNING: TheblueCompressionSleeveisanecessarycomponentoftheExtensionLegAssembly.AlwaysvisuallyconrmthattheCom-

pressionSleeveremainsintheFemaleConnectorduringassembly(Figure7andFigure11).

Figure 11

Blue Compression Sleeve must be present during assembly.

36.AfterExtensionLegAssemblyisoncatheter,ensurecatheterlengthandprimingvolumeprintingisvisible.

37.Graspingtheconnectorinonehand,andthecathetertubingintheother,gentlytugonthejointtotestthesecurityoftheconnector.Ifthe

connectorpullsoutofcatheter,repeattheattachmentprocedure.Aconnectionfailuremaybeduetoone,oracombinationofthefollowing:

 •TheExtensionLegConnectormetalcannulaisnotfullyinsertedintothecatheter.

 •Missingbluecompressionsleeveinfemaleconnector.

38.Withthe10mLsyringeattachedtotheExtensionLegAssembly,removeSlideClampfromcatheter.

WARNING:TheSlideClamp,ThumbClampandPlugareprovidedforuseduringcatheterplacementonly.Donotreuse.

39.Verifycatheterfunctionbyaspiratingtoensureadequatebloodow.Notethatextensionclampsmustbeunclampedtoaspirate.

40.Onceowissatisfactory,ushcatheterwithaminimumof10mLofsterilesaline.

WARNING:Toavoiddamagetovesselsandviscus,infusionpressuresmustnotexceed25psi(172kPa).Theuseofa10mLorlargersyringeis

recommended because smaller syringes generate more pressure than larger syringes.

41.Injectheparinsolutionof1,000to5,000units/mLinamountsequaltotheprimingvolumeasdenotedonthecatheter.Injectquicklyand

clampextensionwhileunderpositivepressure.Attachasterileendcap.WARNING:Failuretoclampextensionswhennotinusemayleadto

air embolism, bleeding, and possible occlusions.

42.Repeatsteps31-41forsecondcatheter(Figure12).

Figure 12

Cu

G. Placement Verication and Securement

43.Afterinsertion,conrmplacementofthecatheterusingx-rayoruoroscopy.

44.Foradditionalsecurity,suturetheinsertionsite,orifpreferred,useaStatLock*

CatheterStabilizationDeviceSecurementdevicetoanchorthecatheter.

45.Managetheexitsiteperhospitalprotocol.

46.Dressthecatheterperhospitalprotocol.

WARNING:AcetoneandPEG-containingointmentscancausefailureofthisdevice

andshouldnotbeusedwithpolyurethanecatheters.Chlorhexidinepatchesor

bacitracinzincointments(e.g.,Polysporin* ointment)arethepreferredalterna-

tive.

47.Recordindwellingcatheterlengthandinsertionsiteonpatient’schart.

PERFORMANCE GUIDELINES

Priming Volumes

Refertoindividualcathetersforprimingvolumeinformationprintedatpre-denedcentimetermarkings.

Assuggestedby In Vitro data

Flow Rate vs Lumen Pressure

Venous

Arterial

35 cm Length (400 ml/min)

50 cm Length (350 ml/min)

199 mmHg

229 mmHg

-208 mmHg

-235 mmHg

Note: Reverse ow will result in higher recirculation

INSERTION TECHNIQUE

Forpercutanenousplacement,thecatheterisinsertedthroughasheathintroducerintothesuperiorvenacavaviatheinternaljugularvein

3,6

(preferred),externaljugularvein,orsubclavianvein.ThepatientshouldbeplacedinTrendelenburgpositionwiththeheadturnedtotheop-

posite side of the entry site.

CATHETERS MUST BE INSERTED UNDER STRICT ASEPTIC CONDITIONS.

WARNING:Cannulationoftheleftinternaljugularveinwasreportedlyassociatedwithahigherincidenceofcomplicationscomparedtocath-

eterplacementintherightinternaljugularvein.

CAUTION:Leftsidedcatheterplacementmayprovideuniquechallengesduetotherightanglesformedbytheinnominateveinandattheleft

brachiocephalicjunctionwiththeSVC.

2,5

A. Sterile Field and Skin Preparation

1. Provideasterileeldthroughouttheprocedure.Usesterilegloves,masks,caps,sterilegowns,andusealargesteriledrapetocoverthe

patient.Ifhairremovalisneededuseclippersordepilatories.

2. Preparetheaccesssiteusingstandardsurgicaltechniqueanddrapethepreppedareawithsteriletowels.

3. (Ifapplicable)administerlocalanaesthesiatotheinsertionsite.

B. Pre-ush the Catheters

Slide Clamp

Thump Clamp

Plug

4. Irrigate,prime,andclampbothcatheterlumenswithheparinsolutionoraccordingtohospitalproto-

col.Withcathetersfullofuid,clampeachcatheterusingSlideClamporThumbClampbetweenthe

proximalendofthecatheterandthe50cmmarkingoruseplug.

C. Perform Venipuncture

5. Inserttheintroducerneedlewithanattachedsyringetothedesiredlocationusingultrasoundguidance(preferred).Aspirategentlyasthe

insertion is being made.

6. Whentheveinhasbeenentered,removethesyringeleavingtheneedleinplaceandoccludeendofneedlewiththumb.

7. InserttheexibleJendofthestandardguidewirethroughtheintroducerneedlehubthatwillpermitpassageofa0.038in.(0.97mm)guide-

wire.Advancethestandardguidewiretothedesiredlocationinvessel.

WARNING:Cardiacarrhythmiasmayresultiftheguidewireisallowedtopassintotherightatrium.

WARNING: Do not advance guidewire or catheter if unusual resistance is encountered.

8. Removetheneedlewhileholdingtheguidewireinplace.Wipetheexposedguidewirecleanandsecureitinplace.

CAUTION:Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandguidewireasaunittopreventthe

needle from damaging or shearing the guidewire.

9. Repeatsteps5-8abovetointroducesecondneedleandguidewireintosametargetveinapproximately1-2cmadjacenttotherstincision

site.

10.Aftersecondwirehasbeenplaced,makeasmallincisionateachvenousinsertionsitetoremoveanydermalbridgeandeaseinsertion.

D. Insert Sheath and Advance Catheter

11.Advancethedilatorsheathintroducerovertheexposedguidewireintothevessel.

CAUTION:CareshouldbetakenNOTtoforcethedilatorsheathintroducerintothevesselduringinsertionasvesseldamageincluding

perforation could result.

WARNING:Cardiacarrhythmiasmayresultiftheguidewireisallowedtopassintotherightatrium.

12.Withdrawthedilatorandguidewire,leavingthesheathintroducerinplace.

CAUTION:Careshouldbetakennottoadvancethesplitsheathtoofarintovesselasapotentialkinkwouldcreateanimpassetothecath-

eter.

WARNING:Topreventairembolismand/orbloodloss,placethumbovertheexposedoriceofthesheathintroducer.

13.Removethumbandfeeddistalsectionofcatheterintothesheathintroduceruntiltipiscorrectlypositioned.Thedepthmarkingsinonecm.

increments may be used to determine insertion length.

WARNING:Ensurethecatheterislledwithheparinizedsaline,isclampedandisfreeofairbubblesbeforeinsertingitintothevein.

WARNING: Do not advance guidewire or catheter if unusual resistance is encountered.

14.Withthecatheteradvanced,peelawaythesheathintroducerbygrippingthe“T”handleandbreakingitapartwithadownwardandoutward

motion to initiate separation and withdrawal of the sheath introducer.

CAUTION:Ensurethatthesheathintroducerisonlytornexternally.Cathetermayneedtobefurtherpushedintothevesselassheathintro-

ducer is torn.

CAUTION:Foroptimalproductperformance,donotinsertanyportionofthecuintothevein.

15.Repeatsteps11-14aboveforsecondcatheter.

16.Verifycatheterpositionunderuoroscopyandmakenecessaryadjustments.The venous (infusion) tip should be located at the level of

the caval atrial junction or into the right atrium and approximately 4 cm past the arterial (withdrawal) catheter tip.

CAUTION:Cathetertipsmustbestaggeredby4cmtominimizerecirculation.

E. Subcutaneous Tunneling of Catheters and Cu Placement

Tu nnel Tr act

Catheter

Exit Site

Catheter

Insertion

Site

Figure 1

17.Identifydesiredtunnellocationandexitsitetoinsureagentlearc.Ensure

thattheexposedproximalportionofcatheterislongenoughtocutthe

cathetertothedesiredlengthandtoreadlengths/primingvolumes.

18.Makenoteofthedesiredlocationatwhichthecuwillresideinthetunnel.

19.(Ifapplicable)administerlocalanaesthesiatotunneltract.

20.Makeanincisionatthecatheterexitsite(Figure1).

21.Usingthemetaltunnelerprovided,createasubcutaneoustunnelfromthe

insertionsitetoemergeatthecatheterexitsite(Figure2b).

WARNING: Do not tunnel through muscle.

22.Oncemetaltunneleremergesfromcatheterexitsite,placetaperedend

of tunnel slide dilator over tip of tunneler at insertion site. While holding

endofmetaltunneler,expandtunneltractfrominsertionsitetohalfway

throughthetunneltodesiredculocationorwithin2cmofthecatheter

exitsiteusingaback-and-forthmotion(Figure3aand3b).

Figure 2bFigure 2a

Tunneler

Tunnel Slide Dilator

Figure 2c