3 table of contents · introduction 1 powerport* implantable port description - powerport*...

3Table of Contents

Introduction 1

PowerPort* Implantable PortDescription-PowerPort*ImplantablePort 1

IndicationsForUse 2

Warnings 2

Precautions 2

PossibleComplications 3

PowerPort* DevicesUseandMaintenance 3

AccessingImplantablePorts 4

BolusInjectionProcedureOtherThanPowerInjection 5

ContinuousInfusionProcedure 6

BloodSamplingProcedure 8

LockProcedureforCatheters 8

RecommendedFlushingVolumes,Open-EndedCatheters 9

RecommendedFlushingVolumes,Groshong*Catheters 9

MRIScans 10

PowerLoc* Safety Infusion Set Family† DevicesDescription-PowerLocSafetyInfusionSetFamily†Devices 11

IndicationsforUse 11

Contraindications(whenusedwithanimplantablepower11injectableport)

Insertion 12

Removal 13

MRIScans 13

Troubleshooting Guide 14

Power Injection InformationImportantInformation 17

PowerInjectablePort&NeedleIdentification 18

PowerInjectionProcedure 20

References 21

Further Reading 21

11 2

IndicationsForUse

ThePowerPort*ImplantablePort is indicatedforpatienttherapiesrequiringrepeatedaccesstothevascularsystem.Theportsystemcan be used for infusion of medications, I.V. fluids, parenteralnutritionsolutions,bloodproducts,andforthewithdrawalofbloodsamples.

WhenusedwithaPowerLoc*SafetyInfusionSetFamily†device,thePowerPort*deviceisindicatedforpowerinjectionofcontrastmedia.Forpowerinjectionofcontrastmedia,themaximumrecommendedinfusionrateis5mL/second.

Warnings

• Donotpowerinjectthroughaportsystemthatexhibitssignsofclavicle-firstribcompressionorpinch-offasitmayresultinportsystemfailure.

• Intended for Single Patient Use. DO NOT REUSE. Bard AccessSystems,Inc.productsaresingleusedevicesandshouldneverbe reimplanted. Any device that has been contaminated bybloodshouldnotbereusedorresterilized.

• After use, this product may be a potential biohazard. Handleanddiscardinaccordancewithacceptedmedicalpracticeandapplicablelocal,stateandfederallawsandregulations.

• The use of an infusion set other than a PowerLoc* SafetyInfusionSetFamily†deviceduringpowerinjectionmayleadtosystemfailureandpossiblypatientinjury.

• Donotuseasyringesizesmallerthan10mL.Flushing occludedcatheters with small syringes can create excessive pressurewithintheportsystemandleadtoportsystemfailure.

Precautions

• Carefullyreadandfollowallinstructionspriortouse.• FollowUniversalPrecautionswhenaccessingtheport.• Follow all contraindications, warnings, precautions and

instructionsforallinfusatesasspecifiedbytheirmanufacturers.• Precautionsareintendedtohelpavoidproductdamageand/or

patientinjury.• Only accessories and components with luer lock connections

shouldbeusedwiththisdevice.• If signs of extravasation exist, discontinue injections. Begin

appropriatemedicalinterventionimmediately.• Useonlynon-coringneedleswiththeport.

Introduction

Bard Access Systems’ PowerPort* power-injectable port andPowerLoc* Safety Infusion Set Family† devices not only facilitateinfusions,buttheyarethefirstportandneedlesystemindicatedforthepowerinjectionofcontrastmediaforCECTscans.

Contrastenhancedcomputedtomography(CECT)scansaresimple,safeandnon-invasiveproceduresthatprovidequickandaccuratediagnostic information to help track tumor markers or diagnosepulmonaryembolisms,forexample.Thescansaremanytimesmoresensitive than conventional x-rays. Radiologists can distinguishsmall differences in soft tissues that may not be detected withx-rays.

Before performing a CECT scan, the CT team will inject a contrastagent,which isaspecial fluidthatacts likeadye, intothepatienttohelpproduceclearerpicturesduring theCECTscanprocedure.Forbestresults,thecontrastagentisinfusedatahighrateintothebloodstream.Thisprocessiscalledpowerinjection.

Bard’s PowerPort* power-injectable port used with a PowerLoc*Safety Infusion Set Family† device has the unique ability to allowclinicianstoperformpower-injectedCECTscanswithouthavingtouseperipheralI.V.needles.

PowerPort* Implantable Port

Description-PowerPort*ImplantablePort

The PowerPort* Implantable Port and PowerLoc* Safety InfusionSet Family† devices are access devices designed to providerepeated access to the vascular system. Port access is performedby percutaneous needle insertion using a non-coring needle.Power injection is performed using a PowerLoc* Safety InfusionSetFamily†device.ThePowerPort*deviceconsistsoftwoprimarycomponents: an injection port with a self-sealing silicone septumand a radiopaque catheter. Single lumen PowerPort* implantableports can be identified subcutaneously by feeling the top of theseptum which includes three palpation bumps arranged in atriangleandbypalpatingthesidesoftheport,alsoinatriangularshape.DuallumenPowerPort*implantableportscanbeidentifiedsubcutaneously by feeling the tops of each septum. Each septumhasthreepalpationbumpsarrangedinatriangle.Allmaterialsarebiocompatible, can be used with virtually all injectable solutionsandcanbesafelyusedwithCECT.

For Implantable ports with Groshong* catheters, the Groshong*catheter valve helps provide security against blood reflux and airembolismintotheport/cathetersystem.TheGroshong*cathetermay be flushed with sterile normal saline and does not requireheparintomaintainpatency.

†PowerLoc*,PowerLoc*Clear,andPowerLoc*MAXSafetyInfusionSets(SIS)

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PossibleComplications

The use of a subcutaneous port provides an important meansof venous access for critically ill patients. However, the potentialexists for serious complications, including, but not limited to thefollowing:

• AirEmbolism• Bleeding• BrachialPlexusInjury• CardiacArrhythmia• CardiacTamponade• CatheterorPort

ErosionThroughtheSkin

• CatheterEmbolism• CatheterOcclusion• CatheterOcclusion,

DamageorBreakageduetoCompressionbetweentheClavicleandFirstRib

• CatheterorPortrelatedSepsis

• DeviceRotationorExtrusion

• Endocarditis• Extravasation• FibrinSheath

Formation• Hematoma• Hemothorax• Hydrothorax• IntoleranceReactionto

ImplantedDevice• Inflammation,Necrosis,

orScarringofSkinOverImplantArea

• LacerationofVesselsorViscus

• PerforationofVesselsorViscus

• Pneumothorax• SpontaneousCatheter

TipMalpositionorRetraction

• ThoracicDuctInjury• Thromboembolism• VascularThrombosis• VesselErosion• RisksNormally

AssociatedwithLocalorGeneralAnesthesia,Surgery,andPost-OperativeRecovery

These and other complications are well documented in medicalliterature.

PowerPort* Devices

UseandMaintenance

Site PreparationAlways inspect and aseptically prepare the injection site prior toaccessingtheport.

Note: It is recommended that catheter tip placement is verifiedthroughinstitutionalprotocol.

Equipment:• Alcoholorchlorhexidinewipe• Antisepticswabs(3)• Sterilegloves

Procedure:1. Explain procedure to patient. Warn of needle prick sensation.

(Sensation of needle insertion decreases over time. Use of atopicalanestheticmaybeappropriate.)

2. Washhandsthoroughly.3. Putonsterilegloves.4. Cleanse or scrub the area according to the cleansing agent

manufacturer’s instructions.We suggest an area of at least 10–13cm(approximately4x5in.)diameterattheportinsertionsite.

Directions for the use of ChloraPrep* preoperative skin preparation: Prepare the site with ChloraPrep* One-Step Applicator Solutionoraccordingto institutionalpolicyusingsteriletechnique.“Pinch-Off” the wings on the ChloraPrep* One-Step Applicator Solutionto break the ampule and release the antiseptic. Do not touch thesponge. Wet the sponge against the treatment area until fluid isvisibleontheskin.Userepeatedback-forthstrokesofthespongefor approximately 30 seconds. Completely wet the treatmentarea with antiseptic. Allow the area to dry for approximately 30seconds. Do not blot or wipe away. Maximum treatment area foroneapplicator isapproximately130cm2 (approximately4x5 in.).Discardtheapplicatorafteruse.

Note:FollowestablishedhospitalorinstitutionalpolicyforchangingI.V. tubing and accessing cannula.The Center for Disease Control(CDC)orOncologyNursingSociety(ONS)mayhaverecommendedguidelines.

AccessingImplantablePorts

Equipment:• Syringe• If the port will be accessed for power injection, it must be

accessedwithaPowerLoc*Safety InfusionSetFamily†device.Ifnotpower injecting, itcanbeaccessedwithanynon-coringsafetyneedle.Chooseaneedlelengthbasedonreservoirdepth,tissuethickness,andthethicknessofanydressingbeneaththebendoftheneedle.

Procedure for single lumen PowerPort* devices:1. Performasepticsitepreparation.2. Locateportseptumbypalpation. a.Locatebaseofportwithnon-dominanthand. b.Triangulateportbetweenthumbandfirsttwofingersofnon-

dominanthand.Aimforcenterpointofthesethreefingers.

3. InsertPowerLoc*SafetyInfusionSetFamily†deviceorothernon-coring safety needle perpendicular to port septum. Advanceneedlethroughtheskinandseptumuntil reachingbottomofreservoir. Make certain that needle tip is inserted fully withintheport.

4. Confirm correct positioning of the needle within the portreservoir by aspiration of blood (“flashback”). If there is doubtregarding proper needle placement, have a radiographic dyeproceduredonetoconfirmplacement.

5. Alwaysflushtheportreservoirfollowinginjection.6. Performheparinlockprocedureforopen-endedcatheters.For

implantable ports with Groshong* catheters, a sterile normal

Feel the soft top of the port to locate the three palpation bumps arranged in a triangle.

Feel the sides of the port to identify its unique triangle shape.

5 6

saline lock may be used. Caution: Remember that somepatientsmaybehypersensitivetoheparinorsufferfromheparininduced thrombocytopenia (HIT) and these patients must nothavetheirportlockedwithheparinizedsaline.

7. When deaccessing the port, the needle should be removedusing the positive pressure technique. Positive pressure ismaintained while flushing the accessed port by clamping theinfusionsettubing,whilestillflushingtheline.Thishelpsreducethe potential for blood backflow into the catheter tip, whichcouldencouragecatheterclotting. IfusingaPowerLoc*SafetyInfusion Set Family† device, activate safety mechanism whilewithdrawingtheneedle.

Procedure for dual lumen PowerPort* devices:1. Performasepticsitepreparation.2. Locateportseptumbypalpation. a.Locatebaseofportwithnon-dominanthand. b.LocatecenterofduallumenportbypalpatingSeptum-Finder*

Ridgeontopofportandplaceindexfingerofdominanthandtomark.

c.Triangulate right or left side of dual lumen port betweenthumbandfirsttwofingersofnon-dominanthand. Aimforcenterpointofthesethreefingers.

3. Insertneedleperpendiculartoportseptum.AdvancePowerLoc*SafetyInfusionSetFamily†devicethroughtheskinandseptumuntilreachingbottomofreservoir.

4. Confirmcorrectneedleplacementbybloodaspiration.5. Flusheachlumenseparatelyfollowinginjection.6. Performheparinlockseparatelyoneachlumen.7. When deaccessing the port, the needle should be removed

using the positive pressure technique. Positive pressure ismaintained while flushing the accessed port by clamping theinfusionsettubing,whilestillflushingtheline.Thishelpsreducethe potential for blood backflow into the catheter tip, whichcouldencouragecatheterclotting. IfusingaPowerLoc*SafetyInfusion Set Family† device, activate safety mechanism whilewithdrawingtheneedle.

BolusInjectionProcedureOtherThanPowerInjection

Equipment:• PowerLoc*SafetyInfusionSetFamily†device.Chooseaneedle

length based on reservoir depth, tissue thickness, and thethicknessofanydressingbeneaththebendoftheneedle.

• Syringefilledwithsterilenormalsaline• Extensionsetwithclamp

Procedure:Review Site Preparation and Accessing Implantable Port sectionsbeforeproceedingwiththissection.

5

1. Explain procedure to patient and prepare injection site.Remember to check patient’s records and ask the patient todeterminewhethertheyhaveanyknownallergiestochemicalsormaterialsthatwillbeusedduringtheinjectionprocedure.

2. Attach PowerLoc* Safety Infusion Set Family† device or othernon-coringsafetyneedletoextensionsetandsyringefilledwithsterilenormalsaline.Expelallairandclampextension.

3. Aseptically locateandaccessport.Confirmcorrectpositioningof the needle within the port reservoir by aspiration of blood(“flashback”). If there is doubt regarding proper needleplacement,havearadiographicdyeproceduredonetoconfirmplacement.

4. Flushportwith10mLsterilenormalsaline.Clamptheextensionsetandremovethesyringe.

5. Connectsyringecontainingthedrugtoextensionset.Releaseclampandbegintoadministerinjection.

6. Examine the injection site for signs of extravasation; if noted,immediatelydiscontinuethe injectionand initiateappropriateintervention.

7. Whentheinjectioniscompleted,clamptheextensionset.8. Flushaftereachinjectionwith10mLofsterilenormalsalineto

helppreventinteractionbetweenincompatibledrugs.9. For open-ended catheters: Flushportwith5mLheparinized

salineaftereveryuseandatleastonceevery4weeks. For dual lumen catheters: Flush each lumen with 5 mL

heparinized saline to help prevent interaction betweenincompatible drugs after every use and at least once every 4weeks.

For Groshong* catheters:Asterilenormalsalinelockmaybeused.Flushportwith5mLofsterilenormalsalineatleastonceevery4weeks.

Caution:Rememberthatsomepatientsmaybehypersensitiveto heparin or suffer from heparin induced thrombocytopenia(HIT) and these patients must not have their port locked withheparinizedsaline.

Note: For Groshong* and open-ended catheters, the needlehubshouldnotbeleftopentoairwhileitisintheport.Donotmanipulatetheneedleonceitisintheseptum.

10. When deaccessing the port, the needle should be removedusing the positive pressure technique. Positive pressure ismaintained while flushing the accessed port by clamping theinfusionsettubing,whilestillflushingtheline.Thishelpsreducethe potential for blood backflow into the catheter tip, whichcouldencouragecatheterclotting.

ContinuousInfusionProcedure

Caution: Do not use a syringe size smaller than 10 mL. Flushingoccluded catheters with small syringes can create excessivepressureswithintheportsystem.

Equipment:• PrescribedI.V.solution• Extensionsetwithclamp• 10mLsyringefilledwithsterilenormalsaline• PowerLoc* Safety Infusion Set Family† device, or other non-

coringsafetyneedle.Chooseaneedlelengthbasedonreservoirdepth, tissue thickness, and the thickness of any dressing

Palpate port housing. Locate Septum-Finder* Ridge and palpation bumps.

7 8

BloodSamplingProcedure

Equipment:• Extensionsetwithclamp• PowerLoc* Safety Infusion Set Family† device or other non-

coringsafetyneedle.Chooseaneedlelengthbasedonreservoirdepth, tissue thickness, and the thickness of any dressingbeneaththebendoftheneedle.

• Syringefilledwithsterilenormalsaline• Syringe(2)orevacuatedbloodcollectionvials(2)• Sterilenormalsaline

Procedure:Review Site Preparation and Accessing Implantable Ports sectionsbeforeproceedingwiththissection.1. Explainproceduretopatientandprepareinjectionsite.2. Aseptically locate and access port with a PowerLoc* Safety

InfusionSetFamily†deviceorothernon-coringsafetyneedle.Confirm correct positioning of the needle within the portreservoir by aspiration of blood (“flashback”). If there is doubtregarding proper needle placement, have a radiographic dyeproceduredonetoconfirmplacement.

3. Flushportwithsterilenormalsaline.4. Withdrawatleast5mLofbloodanddiscardsyringe.5. Aspiratedesiredbloodvolumeintosecondsyringeorevacuated

bloodcollectionsystem.6. Once sample is obtained, perform saline lock procedure by

immediately flushing the system with 20 mL of sterile normalsaline.

7. Transfersampleintoappropriatebloodsampletubes.8. Perform heparin lock procedure for open-ended

catheters. For implantable ports with Groshong* catheters, a sterile normal saline lock may be used.Caution:Rememberthatsomepatientsmaybehypersensitiveto heparin or suffer from heparin induced thrombocytopenia(HIT) and these patients must not have their port locked withheparinizedsaline.


LockProcedureforCatheters

Tohelppreventclotformationandcatheterblockage,implantableportsshouldbeflushedperinstitutionalprotocolusingaturbulentpush-pause flushing method after each use. Clamp the tubingwhile infusing the last 0.5 mL of fluid to reduce potential forblood back-flow into the catheter tip, which could encouragecatheter clotting. If the port remains unused for long periodsof time, the 5 mL heparin solution or sterile normal salinesolution should be changed at least every four weeks, per lumen.Caution: Rememberthatsomepatientsmaybehypersensitivetoheparinorsufferfromheparininducedthrombocytopenia(HIT)andthese patients must not have their port locked with heparinizedsaline.

beneaththebendoftheneedle.• I.V.pole• I.V.pump(ifordered)• Transparentdressing• 2in.x2in.(5cmx5cm)gauzepads

Procedure:Review Site Preparation and Accessing Implantable Port sectionsbeforeproceedingwiththissection.1. Explain procedure to patient and prepare injection site.

Remember to check patient’s records, and ask the patient, todeterminewhethertheyhaveanyknownallergiestochemicalsormaterialsthatwillbeusedduringtheinjectionprocedure.

2. AttachaPowerLoc*SafetyInfusionSetFamily†deviceorothernon-coringsafetyneedletoextensionsetandsyringefilledwithsterilenormalsaline.Expelallairandclamptheextensionset.

3. Aseptically locateandaccessport.Confirmcorrectpositioningof the needle within the port reservoir by aspiration of blood(“flashback”). If there is doubt regarding proper needleplacement,havearadiographicdyeproceduredonetoconfirmplacement.

4. Secure needle with transparent dressing to help preventinadvertentdislodgement.Note:Forcontinuousaccess,changenon-coringneedleandtransparentdressingeveryweek.

5. Open clamp and flush port with sterile normal saline. Clampextensionsetandremovesyringe.

6. Connect fluid delivery system (I.V. set or infusion pump asindicated).Note:AlwaysuseLuerlockconnectionsonalltubingsandconnections.Neveruseasliptipconnection.Pumpsmustincorporate a functional automatic pressure limiting switchwhichwillshutpumpoffbeforepressureexceeds25psi.

7. Release clamp and initiate infusion. Examine the infusion sitefor signs of extravasation; if noted, or if patient experiencespain,immediatelydiscontinueinfusionandinitiateappropriateintervention.

8. When infusion is completed, clamp extension set and thenremovethefluiddeliverysystem.

9. Flushaftereachinfusionwith10mLsterilenormalsalinetohelppreventinteractionbetweenincompatibledrugs.

10. For open-ended catheters: Flushportwith5mLheparinizedsaline after every use and at least once every 4 weeks.For dual lumen catheters: Flush each lumen with 5 mLheparinizedsalineaftereveryuseandat leastonceeveryfourweeks.

For Groshong* catheters:Asterilenormalsalinelockmaybeused.Flushportwith5mLofsterilenormalsalineatleastonceevery4weeks.


Note: For Groshong* and open-ended catheters, the needlehubshouldnotbeleftopentoairwhileitisintheport.Donotmanipulatetheneedleonceitisintheseptum.


7

9 10

Determining Port VolumesFor PowerPort* implantable ports, you will need to check thepatient’s chart to determine the length of catheter used for eachindividual patient. For PowerPort* implantable port catheters, usetheformulaandtablesbelow:

Port System Volume = Catheter length: _______cm x cathetervolumecm

+reservoirvolume.

RecommendedFlushingVolumes,Open-EndedCatheters

Equipment:• PowerLoc* Safety Infusion Set Family† device, or other non-


• 10mLsyringefilledwithsterileheparinizedsaline(100U/mL).

RecommendedFlushingVolumes,Groshong*Catheters

Equipment:• PowerLoc* Safety Infusion Set Family† device, or other non-


• 10mLsyringefilledwithsterilenormalsaline

Procedure:Review Site Preparation and Accessing Implantable Port sectionsbeforeproceedingwiththefollowing:1. Explainproceduretopatientandprepareinjectionsite.2. Attachasyringefilledwithsterilenormalsalineorheparinized

saline(asapplicable)toneedle.3. Aseptically locate and access port with a PowerLoc* Safety

InfusionSetFamily†deviceorothernon-coringsafetyneedle.Confirm correct positioning of the needle within the portreservoirbyaspirationofblood(“flashback”). Ifthereisdoubtregarding proper needle placement, have a radiographic dyeproceduredonetoconfirmplacement.

4. After therapycompletion, flushportper institutionalprotocol.Closeclampwhileinjectinglast0.5mLofflushsolution.

5. To deaccess a PowerLoc* Safety Infusion Set Family† devicefrom the port, activate safety mechanism while withdrawingneedle.

Note: Alcoholshouldnotbeusedtosoakordeclotpolyurethanecathetersbecausealcoholisknowntodegradethepolyurethanecathetersovertimewithrepeatedandprolongedexposure.

MRIScans

Non-clinicaltestinghasdemonstratedthedeviceisMRconditional.Itcanbescannedsafelyunder:• Staticmagneticfieldof3teslaorless • Spacialgradientfieldof330Gauss/cmorless• Maximumspecificabsorptionrate(SAR)of4W/kgfor30minutes

ofscanning

In non-clinical testing, the PowerPort* device produced atemperatureriseoflessthan0.50Catamaximumspecificabsorptionrate(SAR)of4W/kgfor30minutesofMRscanningina3TSiemensTriowithsoftwareversionVA25.

ForMinimalImageArtifact• MR image quality may be compromised if the area of interest

is in the same area or relatively close to the position of thedevice.Therefore,itmaybenecessarytooptimizeMRimagingparametersforthepresenceofthismetallicimplant.

9

Catheter Volumes

Procedure6F Chronof lex* catheter 0 .014 mL

0.02 mL

0.02 mL

0.02 mL

0.02 mL

8F Chronof lex* catheter

9 .6F S i l icone

8F Groshong* catheter

9 .5F Chronof lex* (dual lumen)

(per lumen)Volumecm

Reservoir VolumesPort

PowerPort*,PowerPort* isp,PowerPort*Duoimplantableport

PowerPort*Slimimplantableport

0 .6 mL

0.5 mL

Reser voir Volume(per lumen)

Procedure

Flushing Volumes - Open-Ended Catheters (per lumen)

Whenportisnotinuse

Afterbloodwithdrawal

AftereachinfusionofmedicationorTPN

5mLheparinizedsalineevery4weeks

10mLsterilenormalsalinethen5mLheparinizedsaline



Afterpowerinjectionofcontrastmedia

Volume (100 U/mL)

Procedure

Flushing Volumes - Groshong* Catheters (per lumen)

Whenportisnotinuse

Afterbloodwithdrawal

AftereachinfusionofmedicationorTPN

5mLsterilenormalsalineevery4weeks

10mLsterilenormalsaline

20mLsterilenormalsaline

10mLsterilenormalsalineAfterpowerinjection

ofcontrastmedia

Volume (100 U/mL)

MRConditional

11 12PowerLoc* Safety Infusion Set Family† DevicesDescription - PowerLoc* Safety Infusion Set FamilyDevices

PowerLoc*SafetyInfusionSetFamily†Devicesarepowerinjectablesafetyinfusionsetsidealforaccessingpowerinjectableports.Thispower-combo enables contrast agents to be power-injected. As aresult,tissuesshowupmoreclearlyinCECTscans,makingiteasiertomonitorpatientcondition.IndicationsForUse

The PowerLoc* Safety Infusion Set Family† of devices is intendedfor use in the administration of fluids and drugs, as well as bloodsampling through surgically implanted vascular ports. ThePowerLoc*SafetyInfusionSetFamily†ofdevicesarealsoindicatedforpowerinjectionofcontrastmediaintothecentralvenoussystemonly with an implantable port that is also indicated for powerinjection.Themaximumrecommendedinfusionrateat11.8cPsis5mL/secondfor19Ga.needles,5mL/secondfor20Ga.needles,and2mL/secondfor22Ga.needles.

Contraindications

• DO NOT USE, if the presence of a device related infection,bacteriaorsepticemiaisknownorsuspected.

• DO NOT USE,if local tissue factors will prevent proper devicestabilizationand/oraccess.

Whenusedwithanimplantablepowerinjectableportfor contrast media infusion, the following warningsapply:

• When a PowerLoc* Safety Infusion Set Family† device is usedfor power injection of contrast media, it must be used inconjunctionwithanimplantablepower-injectableport,suchastheBardPowerPort*device.AllBardPowerLoc*SafetyInfusionSet Family† devices have been tested and verified for powerinjectionwithBardPowerPort*devices.

• Verify patient has an implanted power injectable port. Whenused specifically for power-injection, a PowerLoc* SafetyInfusionSetFamily†devicemaybeusedonlyintandemwithanappropriatepower-ratedport.

• Bard PowerPort* device: A Bard PowerPort* device can beidentifiedbyanytwoofthefollowingmethods:• Palpationbumps,triangularshape,radiopaqueCTidentifier,

PowerPort* device patient ID card, ID bracelet, keychain, orPowerPort*devicemedicalrecord.

• Other Power-Injectable Ports: Verify identification methodsperportmanufacturer’sinstructions.

• Do not power inject through a PowerLoc* Safety Infusion SetFamily†deviceunlessbloodreturnisconfirmed.

• Failure to warm contrast media to body temperature prior topowerinjectionmayresultindevicefailure.

• Exceedingtheindicatedmaximumflowrate,andthemaximumrecommendedpressurelimitsettingofthepowerinjectormayresult indevice failure.Refer to individualproduct labelingformaximumpressuresettingofthepowerinjector.

• WhenpowerinjectingthroughaPowerLoc*SafetyInfusionSetFamily†devicewithaY-site,replaceanyneedlelesscapontheunusedextensionlegwithadead-endcapandtighten.

• Vigorouslyflushthedeviceusinga10mLorlargersyringeandsterile normal saline prior to and immediately following thecompletionofpowerinjectionstudies.

• The PowerLoc* Safety Infusion Set Family† device indicationfor power injection of contrast media implies the ability ofthe system to withstand the procedure, but does not implyappropriateness of the procedure for a particular patient. Asuitablytrainedclinicianisresponsibleforevaluatingthehealthstatusofapatientasitpertainstoapowerinjectionprocedure.

I nser t ion

1. Preparetheportsiteforsterileaccessingfollowinginstitutionalprotocol.

2. Primeinfusionsetusingaseptictechniquefollowinginstitutionalprotocol.

3. Verifycorrectneedleplacementbyaspiratingforblood.4. Flushperinstitutionalprotocolandcloseclamponextension

tubing.5. Secure needle to site following institutional protocol. Do

notmanipulatethetubingonceitisintheseptum.

PowerLoc*Device

PowerLoc*ClearDevice

Access: Insert needle per-pendicular to the port sep-tum.Note:Itisnotnecessaryto push downward on frontof device while accessingtheport.

Safe: Visually observe theorangedot.Disposeofsetinasharpscontainer.

Deaccess: Firmly pull thewings up until you hear orfeela“click”.

Orient wings in single ordualportsasshown.

Access: Grasp grip areabetween thumb and middlefinger.Pressdownwithindexfinger.

Safe: Dispose of set in asharpscontainer.

Deaccess: Graspwingedgeswith thumb and insideknuckle of index finger, liftand squeeze until you hear,see,orfeela“click”.

Orient wings in single ordualportsasshown.

13 14PowerLoc*MAXDevice

Removal

1. After therapy completion, flush port per institutionalprotocol. Close clamp while injecting the last 0.5 mL ofsolution.

2. Withnon-dominanthand,stabilizetheport.3. Deaccessper instructionsof theappropriatedevice listed

above.

MRIScans

Non-clinicaltestinghasdemonstratedthedeviceisMRconditional.Itcanbescannedsafelyunder:• Staticmagneticfieldof3teslaorless • Maximumspecificabsorptionrate(SAR)of4W/kgfor15minutes

ofscanning• Spatialgradientfieldof360Gauss/cmorless

In non-clinical testing, the PowerLoc* device produced atemperature rise of less than 1.2 0C at a maximum whole bodyaveragedspecificabsorptionrate(SAR) of4W/kg,asassessedbycalorimetryfor15minutesofMRscanningina3 Tesla Siemens Trio using software version VA25.

In non-clinical testing, the PowerLoc* Clear device produced atemperature rise of less than 1.4 0C at a maximum whole bodyaveragedspecificabsorptionrate(SAR) of4W/kg,asassessedbycalorimetryfor15minutesofMRscanningina3 Tesla Siemens Trio using software version VB15.

In non-clinical testing, the PowerLoc* MAX device produced atemperature rise of less than 1.6 0C at a maximum whole bodyaveragedspecificabsorptionrate(SAR) of4W/kg,asassessedbycalorimetryfor15minutesofMRscanningina3 Tesla Siemens Trio using software version VB15.

ForMinimalImageArtifact• MRimagequalitymaybecompromisediftheareaofinterestis

withinthedistance,specifiedinthetablebelow,tothepositionof the device. Therefore, it may be necessary to optimize MRimagingparametersforthepresenceofthismetallicimplant.

Troubleshooting Guide

I. Aspiration Difficulties: Do not power inject if you cannot aspirate as patient injury may result.

A. Possible Causes1. Failuretoflushadequately,resultinginlumenobstruction.2. Cathetertipsuckinguptoveinwallwithaspiration.3. Blood clot, fibrin sheath, or particulate matter obstructing

lumenwhencatheterisaspirated. •Aclotorotherobstructioninthecatheterlumencanproducea

one-wayvalveeffect.Duringinfusion,thecatheterwallexpandsslightly and allows fluid to flow around the plug. Duringaspiration, the catheter wall contracts slightly, tighteningdownaroundtheobstructionandpreventingaspiration.

•Fibrinsheathsusuallybegintoformwithinafewdaysaftertheinsertionofacentralvenouscatheter.Ifithasgrownenoughtoextendbeyondthetipofthecatheter,itmaybepulledintoandobstruct the catheter opening when aspiration is attempted,butnotresistinfusion.

4. Compression or transection of the catheter between the clavicleandfirstrib(“pinch-offarea”).

5. Kinkedcatheter. •Cathetermaybepulledtootightthroughskintunnel,causing

kink at vessel insertion site, or where it curves into thesubcutaneoustunnel.

•Cathetermaybecurledorkinkedwithinthevessel,orunderthedressing.

6. Malpositionofcathetertip(i.e.jugularvein,outsideofvein).7. Impropercatheterlengthselectionforpatientsize.

B. Possible Solutions1. Ifno resistance to infusion is felt,attempt to flushwith10mL

normalsaline.Thenpullbackgentlyonsyringeplunger2-3mL,pauseandproceedwithaspiration.

2. If resistanceto infusionisfelt,checkforsignsofextravasation.If present, notify physician of possible catheter leakage ortransectionandembolization.Ifnotpresent,seestep4.

3. Attempttoaspiratewitha20mLsyringe.4. Move patient’s arm, shoulder and head to see if a change

in position will allow aspiration. If aspiration can only beaccomplishedwiththepatientinacertainposition,thepatientshouldbeexaminedtoseeifthecatheterhasbeenplacedinthe“pinch-off”area.

5. Obtain physician’s order for a chest x-ray to determine thepositionofthecatheter.

•Ifthecathetertipisnotinthesuperiorvenacava,thecathetershouldberepositioned.

•If the catheter tip is not in a vein, the catheter should bereplaced.

•If the catheter has been placed through the“pinch-off” area,betweentheclavicleandthefirstrib,andisbeingcompressedenoughtointerferewithinfusionoraspiration,it isatriskforcatheter transection and embolization. The physician shouldevaluatethepatientforcatheterreplacement.

13

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PowerLoc* Family Device Image Artifact Distance

PowerLoc* SIS 5.5cm

PowerLoc* Clear SIS 6.0cm

PowerLoc* MAX SIS 7.3cm

Access:Insertneedleperpen-dicular to the port septum.Note: The textured handleandbasearenotconnected.Youmaypositionthebaseontheskinasneeded.

Deaccess: Firmly pull thetextured handle up untilyou feel a firm stop and theneedleislockedinthesafetyposition.

Orient device in single ordualportsasshown.

Safe: Dispose of set in asharpscontainer.

“Click”

15 16


IV.CatheterOcclusion:Do not power inject an occluded device.

A. Possible Causes1. Bloodclotcompletelyobstructinglumen.2. May be kinked, coiled, damaged, or compressed between the

clavicleandthefirstrib.3. Cathetertipmaynotbewithinvein.4. Maybepartiallyorcompletelytransected.Transectioncanoccur

fromtherepeatedpressureoftheclavicleandthefirstribonthecatheter during normal movement if it is placed through the“pinch-off”area.

5. Impropercatheterlengthforpatientsize.6. Cathetercanbeblockedfromlipidand/orproteindeposition.

B. Possible Solutions1. Askresponsiblenurseorphysiciantoattempttoaspirateblood

clot.2. Movepatient’sarm,shoulderandheadtoseeifpositionchange

affectsabilitytoinfuse.3. Obtain physician’s order for a chest x-ray to determine the

position of the catheter to rule out “Pinch-off”. The patient’sarmsshouldbedownthepatient’s side to ruleout“Pinch-off”syndrome.

• Ifthecathetertipisnotinthesuperiorvenacava,thecathetershouldberepositioned.

• If the catheter tip is not in a vein, the catheter should bereplaced.

• Ifthecatheterhasbeenplacedthroughthe“pinch-off”area,betweentheclavicleandthefirstrib,andisbeingcompressedenoughtointerferewithinfusionoraspiration,itisatrisk forcathetertransectionandembolization.Thephysicianshouldevaluatethepatientforcatheterreplacement.

V.SignsofPinch-off

A. Clinical:• Difficultywithbloodwithdrawal• Resistancetoinfusionoffluids• Patientpositionchangesrequiredforinfusionoffluidsorblood

withdrawal

II.PatientwithFeverand/orInfection:

A. Symptoms:• Inflammationatincisionsite• Fever• Positivesitecultureand/orbloodculturesB. If signs of infection are present:• Notifyphysician

III.InsufficientFlow:Do not power inject if resistance to flushing seems excessive.

Excessive force must not be used to flush an obstructed lumen.Insufficient blood flow may be caused by the catheter contactingthewalloftheveinoranoccludingclot.Thephysicianmayattempttodissolvetheclotwithafibrinolyticagentbeforepowerinjecting.Physiciandiscretionadvised.

A. Equipment:• PowerLoc* Safety Infusion Set Family† device, or other non-


• Syringecontainingportprimingvolumeofafibrinolyticagent.• Syringefilledwithsterilenormalsaline.

B. Procedure:ReviewSitePreparationandAccessingImplantablePortsectionsbeforeproceedingwiththissection.

1. Explainproceduretopatientandprepareinjectionsite.2. Aseptically locate and access the desired septum with needle

attached to syringe, void of air and filled with port primingvolumeoffibrinolyticagent.Warning:IfaccessingaPowerPort*portwithPowerLoc*SafetyInfusionSetFamily†device,donotaffix the PowerLoc* Safety Infusion Set Family† device stickerthatindicatesthesystemcanbepowerinjected.Powerinjectingablockedcathetercouldleadtocatheterdamageandpatientinjury.

3. Gentlyinstillfibrinolyticsolution.Useagentlepull-pushactiononthesyringeplungertomaximizesolutionmixingwithinportandcatheter.

Warning:Occludedcathetersmaynotacceptallofthesolution.Ifstrongresistanceisfelt,donotattempttoforceintocatheter.

4. Leave solution in place according to drug manufacturer’srecommendationand/ordoctor’sorders.

5. Attempttoaspiratesolutionandtheclot(s).6. Iftheclot(s)cannotbeaspirated,repeatprocedure.7. Once the blockage has been aspirated and discarded, flush

catheterwithatleast20mLofsterilenormalsaline.8. Performheparin lockprocedureforopen-endedcatheters.For

implantable ports with Groshong* catheters, a sterile normalsalinelockmaybeused.


15

A PowerPort* device implanted in patient.

Example of PowerPort* Titanium Devices

Example of PowerPort* M.R.I.* Devices

17 18

B. Radiologic:• Grade1or2distortiononchestX-ray. Pinch-off should be evaluated for degree of severity prior

to explantation. Patients indicating any degree of catheterdistortion at the clavicle/first rib area should be followeddiligently. There are grades of pinch-off that should berecognizedwithappropriatechestx-rayasfollows:2,3

VI.UseofFibrinolyticAgentforCatheterBlockage

Useofafibrinolyticagenthassuccessfullyclearedclottedcatheterswhengentle irrigationandaspirationhavefailed.The instructionsprovidedbythedrugmanufacturershouldbefollowed.

Alcoholshouldnotbeusedtosoakordeclotpolyurethanecathetersbecausealcoholisknowntodegradepolyurethanecathetersovertimewithrepeatedandprolongedexposure.

Power Injection Information

I mpor tant I nformation

• A PowerLoc* Safety Infusion Set Family† device (SIS) mustalways be used to access the PowerPort* implantable port forpowerinjectingcontrastmedia.

• A PowerLoc* Safety Infusion Set Family† device may also beusedtoaccessapower-ratedportforpowerinjectingcontrastmediaifindicatedbytheportmanufacturer.

• Contrastmediashouldbewarmedtobodytemperaturepriortopowerinjection. Warning:Failuretowarmcontrastmediatobodytemperaturepriortopowerinjectionmayresultinportsystemfailure.

17

• Check for patency, via aspiration, then vigorously flush thePowerPort* device using at least 10 mL of sterile normalsaline prior to and immediately following the completion ofpower injection studies. It is important to ensure the patencyof the PowerPort* device to prevent damage to the catheter.Resistancetoflushingmayindicatepartialorcompletecatheterocclusion. Do not proceed with power injection study untilocclusionhasbeencleared.

Warning:Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.Warning:Donotpowerinjectthroughaportsystemthatexhibitssignsofclavicle-firstribcompressionorpinch-offasitmayresultinportsystemfailure.Warning:Powerinjectormachinepressurelimitingfeaturemaynotpreventoverpressurizationofanoccludedcatheter.Warning: Do not exceed a 300 psi pressure limit setting, or themaximum flow rate setting shown below, on the power injectionmachineifpowerinjectingthroughthePowerPort*device:

• Exceedingtheindicatedmaximumflowrateandthemaximumpressurelimitsettingofthepowerinjectormayresultindevicefailure.

Warning: The PowerPort* implantable port indication for powerinjectionofcontrastmediaimpliesthedevice’sabilitytowithstandthe procedure, but it does not imply appropriateness of theprocedure for a particular patient. A suitably trained clinicianis responsible for evaluating the health status of a patient as itpertains to a power injection procedure. The PowerPort* deviceis only power injectable when accessed with a PowerLoc* SafetyInfusionSetFamily†device.

PowerInjectablePort&NeedleIdentification

AlwaysverifythatthepatienthasaPowerPort*ImplantablePortbyat least twomeans.Ensure theport isaccessedwithaPowerLoc*SafetyInfusionSetFamily†device,andverificationtagisaffixedtothePowerLoc*SafetyInfusionSetFamily†deviceextensiontubing,priortopowerinjection.

Bard PowerPort* devices can be distinguished from non-powerinjectableportsthroughthefollowingmeans:

• Patientimplantrecord Checkpatient’schartforaPowerPort*devicepatientrecord sticker.

Grade

Grade 0

Grade 1

Grade 2

Grade 3

Severity

No distortion

Distortion presentwithout luminalnarrowing

Distortion presentwith luminal narrowing

Catheter transec-tion or fracture

Recommended Action

No action.

Chest x-ray should be taken every oneto three months to monitor progressionof pinch off to grade 2 distortion.Shoulder positioning during chest x-rays should be noted as it can contributeto changes in distortion grades.

Removal of the catheter should beconsidered.

Prompt removal of the catheter.PowerLoc*SafetyInfusionSetFamily†DeviceGaugeSize

PowerLoc*SafetyInfusionSetFamily†DeviceGaugeColor

MaximumRecommendedFlowRateSetting

19Ga.

Cream

5mL/sec 5mL/sec 2mL/sec

Yellow Black

20Ga. 22Ga.

PowerLoc*SISandBardPowerPort*Device

PowerLoc*ClearSIS PowerLoc*MAXSIS

Triangularshape

Threepalpationbumpsarrangedinatriangle

PowerPort*ImplantablePortcompatiblecallouttag

A. Patient Chart

19 20PowerInjectionProcedure1. Access the port with a PowerLoc* Safety Infusion Set Family†

device.Makecertainthattheneedletipisinsertedfullywithintheport.

Warning:APowerLoc*SafetyInfusionSetFamily†devicemustalways be used to access the PowerPort* implantable port forpower injecting contrast media. Note: Follow institutionalprotocol to verify correct catheter tip position prior to powerinjection.

2. Attachasyringefilledwithsterilenormalsaline.3. Instructthepatienttoassumethepositiontheywillbeinduring

the power injection procedure, before checking for patency.Aspirateforadequatebloodreturnandvigorouslyflushtheportwithatleast10mLofsterilenormalsaline.Warning:Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultinportsystemfailure.

4. Detachsyringe.5. After confirming the presence of a PowerPort* device and

confirming patency, affix the PowerLoc* Safety Infusion SetFamily†devicepurplestickertothePowerLoc*Safety InfusionSetFamily†devicetoinformCTthatapower-injectablesystemisinplace.

6. Warmcontrastmediatobodytemperature. Warning: Failuretowarmcontrasttobodytemperaturepriortopowerinjectionmayresultinportsystemfailure.

7. Ifpossible,thepatientshouldreceivepowerinjectionwitharmsverticallyabovetheshoulderwiththepalmsofthehandsonthefaceofthegantryduringinjection.Thisallowsforuninterruptedpassageofinjectedcontrastthroughtheaxillaryandsubclavianveinsatthethoracicoutlet.

8. Attach the power injection device to the PowerLoc* SafetyInfusion Set Family† device ensuring connection is secure. Allconnectionsshouldbeluerlockconnections.

Warning: Do not exceed a 300 psi pressure limit setting, or

the maximum flow rate setting shown below, on the powerinjection machine if power injecting through the PowerPort*device:

• Exceedingtheindicatedmaximumflowrateandthemaximumpressurelimitsettingofthepowerinjectormayresultindevicefailure.

9. Instruct the patient to communicate immediately any pain orchangeinfeelingduringtheinjection.Injectwarmedcontrast,takingcarenottoexceedtheflowratelimits.

Warning: If local pain, swelling or signs of extravasationare noted, the injection should stop immediately.Warning:Exceedingthemaximumflowratemayresultinportsystemfailureand/orcathetertipdisplacement.

10. Disconnectthepowerinjectiondevice.Alwaysflusheachlumenof the port following power injection with 10 mL of sterilenormal saline followed by 5 mL heparinized saline for open-endedcathetersor10mLsterilenormalsaline forGroshong*catheters.

11. Performheparinlockprocedureoneachlumenforopen-endedcatheters. For implantable ports with Groshong* catheters, asterilenormalsalinelockmaybeused.

• Patientdischargepacket Askpatienttoseethepatientidentificationcard,braceletor

keychainreceivedwhentheportwasimplanted.

• Palpationoftheport Palpate each septum on the port to identify a triangular

arrangement of three palpation bumps. Palpate sides of asinglelumenporttoidentifytriangularporthousing.

• Radiopaqueidentifier Symbolsonthebottomoftheplasticandtitaniumportsare

visibleunderX-ray,fluoroscopyorotherappropriateimagingtechnology.

If port is flipped, the letters “CT” on the symbol may bereversed.

• PowerLoc*SafetyInfusionSetFamily†deviceverificationsticker. The sticker is placed on extension tubing when a port is

initially identified and accessed. This tag instructs CT topowerinjectthroughthePowerPort*/PowerLoc*system.

PowerLoc*SafetyInfusionSetFamily†DeviceGaugeSize

PowerLoc*SafetyInfusionSetFamily†DeviceGaugeColor

MaximumRecommendedFlowRateSetting

19Ga.

Cream

5mL/sec 5mL/sec 2mL/sec

Yellow Black

20Ga. 22Ga.

Identification card ID BraceletKeychain

B. ID Items

E. Verification Tag for the PowerLoc*Safety Infusion Set Family† needle

C. Port PalpationSingle Port

Feel the soft top of the port to locate the three palpation bumps arranged in a triangle.

Feel the sides of the port to identify its unique triangle shape.

Dual Port

Palpate port housing. Locate Septum-Finder* Ridge and palpation bumps.

D. Radiopaque Identifier

PowerPort* M.R.I.* devices

Titanium PowerPort* device

PowerPort* duo device

* *

21 22 Caution:Rememberthatsomepatientsmaybehypersensitive

to heparin or suffer from heparin induced thrombocytopenia(HIT) and these patients must not have their port locked withheparinizedsaline.

12. After therapycompletion, flushportper institutionalprotocol,and close clamp while injecting last 0.5 mL of flush solution.When deaccessing the port, the needle should be removedusing the positive pressure technique. Positive pressure ismaintained while flushing the accessed port by clamping theinfusionsettubing,whilestillflushingtheline.Thishelpsreducethe potential for blood backflow into the catheter tip, whichcouldencouragecatheterclotting.

SeeaBardAccessSystemsSalesRepresentativeformoreinformationaboutanyoftheseproducts.

References1. BardAccessSystems;“YourPortAccessAdvantage:WhatPatients

andNursesSayAboutPorts”,2005,0710420.2. Hinke,D.H.;Zandt-Stastny,D.A.;Goodman,L.R.;etal.Pinch-off

Syndrome: A complication of implantable subclavian venousaccessdevices.Radiology177:353-356,1990.

3. Ingle,Rebecca;Nace,Corinne,VenousAccessDevices:CatheterPinch-offandFracture,1993,BardAccessSystems,Inc.

4. Venousaccess.com5. www.nursingcenter.com6. Camp-Sorrell, Dawn; “Access Device Guidelines:

RecommendationforNursingPracticeandEducation.”2004

Further Reading• See PowerPort* device IFU, PowerPort* device Nursing Guide,

PowerPort* Patient Guide, PowerLoc* Safety Infusion SetFamily†deviceIFU,andPowerLoc*SafetyInfusionSetFamily†devicewallchartformoredetails.

• BardAccessSystemsisproudtooffer“YourPortAccessAdvantage”*patienteducationmoduleforhelpingpatientsselecttheirbestaccessoption.

• Seewww.powerportadvantage.comAnissuedorrevisiondatefortheseinstructionsisincludedfortheuser’s information. In the event two years have elapsed betweenthis date and product use, the user should contact Bard AccessSystems,Inc.toseeifadditionalproductinformationisavailable.

Reviseddate:March2010

*Bard, Groshong, M.R.I., PowerLoc, PowerPort, Septum-Finder, theradiopaqueidentifier,“Feelandseethestandardofcare”,and“YourPortAccessAdvantage”,aretrademarksand/orregisteredtrademarksofC. R. Bard, Inc. All other trademarks are the property of theirrespectiveowners.

ContrastEnhancedComputedTomographyInformation

ThisdevicedoesnotcontainDEHP

Thisproductandpackagingdonotcontainnaturalrubberlatex.

MRConditional

25

Bard Access Systems, Inc.605North5600WestSaltLakeCity,UT84116USA(801)522-5000ClinicalInformationHotline:800-443-3385OrderingInformation:800-545-0890www.bardaccess.comwww.portadvantage.comwww.powerportadvantage.com

©2010C.R.Bard,Inc.Allrightsreserved.

MC-0475-011003

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