8
Polyurethane PICC with MicroEZ* Universal Microintroducer ACCESS SYSTEMS An issued or revision date for these instructions is included for the user’s 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. Revised date: November 2010 * Bard, PowerPICC, MicroEZ and StatLock are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. © Copyright 2010 C. R. Bard, Inc. All rights reserved. Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 USA 1-801-522-5000 Clinical Information Hotline: 1-800-443-3385 Ordering Information: 1-800-545-0890 www.bardaccess.com 0727953 1011R

with MicroEZ* Universal Microintroducer€¦ · PowerPICC* SV catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable

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Page 1: with MicroEZ* Universal Microintroducer€¦ · PowerPICC* SV catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable

Polyurethane PICCwith MicroEZ* Universal Microintroducer

ACCESS SYSTEMS

An issued or revision date for these instructions is included for the user’s 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.

Revised date: November 2010

* Bard, PowerPICC, MicroEZ and StatLock are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.

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

Bard Access Systems, Inc.605North5600WestSalt Lake City, UT 84116 USA 1-801-522-5000ClinicalInformationHotline: 1-800-443-3385OrderingInformation: 1-800-545-0890www.bardaccess.com

0727953 1011R

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Power Injection Procedure1. Remove the injection/needleless cap from the PowerPICC* SV catheter.2. Attach a 10 mL or larger syringe filled with sterile normal saline.3. Aspirate for adequate blood return and vigorously flush the catheter with the full 10 mL of sterile normal saline. WARNING: Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.4. Detach syringe.5. Attach the power injection device to the PowerPICC* SV catheter per manufacturer’s recommendations.6. Contrast media should be warmed to body temperature prior to power injection. WARNING: Failure to warm contrast media to body temperature prior to power injection may result in catheter failure.7. Use only lumens marked “Power Injectable” for power injection of contrast media. WARNING: Use of lumens not marked “Power Injectable” for power injection of contrast media may cause failure of the catheter.8. Complete power injection study taking care not to exceed the flow rate limits. Do not exceed the maximum power injection flow rate. WARNING: Power injector machine pressure limiting feature may not prevent over-pressurization of an occluded catheter, which may

lead to catheter failure. WARNING: Exceeding the maximum power injection flow rate or setting the power injector pressure limit above 300 psi may result in

catheter failure and/or catheter tip displacement.9. Disconnect the power injection device.10. Replace the injection/needleless cap on the PowerPICC* SV catheter.11. Flush the PowerPICC* SV catheter with 10 mL of sterile normal saline, using a 10 mL or larger syringe. If using a multi-lumen catheter,

flush all lumens. In addition, lock each lumen of the catheter with heparinized saline. Usually one mL per lumen is adequate.

Product DescriptionA family of peripherally inserted central catheters made from specially formulated and processed medical grade materials. Each PowerPICC* SV catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access. The MicroEZ* microintroducer kit is an introducer system designed for access of peripheral veins using a minimal insertion technique for the placement of Bard Access Systems, Inc. Peripherally Inserted Central Catheters (PICC) and Midline Catheters.

Contents are supplied sterile. Sterilized by ethylene oxide. DO NOT RESTERILIZE.

New Important Information:• Contrastmediashouldbewarmedtobodytemperaturepriortopowerinjection. WARNING: Failure to warm contrast media to body temperature prior to power injection may result in catheter

failure.• VigorouslyflushthePowerPICC* SV catheter using a 10 mL or larger syringe and sterile normal saline prior to

and immediately following the completion of power injection studies. If using a multi-lumen catheter, flush all lumens. In addition, lock each lumen of the catheter with heparinized saline. Usually one mL per lumen is adequate. This will ensure the patency of the PowerPICC* SV catheter and prevent damage to the catheter. Resistance to flushing may indicate partial or complete catheter occlusion. Do not proceed with power injection study until occlusion has been cleared.

WARNING: Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.

• Useonlylumensmarked“PowerInjectable”forpowerinjectionofcontrastmedia. WARNING: Use of lumens not marked “Power Injectable” for power injection of contrast media may cause

failure of the catheter.• Donotexceedthemaximumpowerinjectionflowrate. WARNING: Power injection machine pressure limiting feature may not prevent over-pressurization of an

occluded catheter, which may lead to catheter failure. WARNING: Exceeding the maximum power injection flow rate or setting the power injector pressure limit

above 300 psi may result in catheter failure and/or catheter tip displacement.• WARNING: PowerPICC* SV catheter indication for power injection of contrast media implies the catheter’s

ability to withstand the procedure for a particular patient. A suitably trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure.

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IndicationsThe PowerPICC* SV catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Catheter Size Maximum Flow Rate

3 F Single Lumen 1 mL/sec

4 F Dual Lumen 2.5 mL/sec

Contraindications, Warnings and Precautions

ContraindicationsThe device is contraindicated whenever:• Thepresenceofdevicerelatedinfection,bacteremia,orsepticemiaisknownorsuspected.• Thepatient’sbodysizeisinsufficienttoaccommodatethesizeoftheimplanteddevice.• Thepatientisknownorissuspectedtobeallergictomaterialscontainedinthedevice.• Pastirradiationofprospectiveinsertionsite.• Previousepisodesofvenousthrombosisorvascularsurgicalproceduresattheprospectiveplacementsite.• Localtissuefactorswillpreventproperdevicestabilizationand/oraccess.

ChloraPrep* One-Step Applicator Contraindications:• Donotuseinchildrenlessthan2monthsofagebecauseofthepotentialforexcessiveskinirritationandincreased

drug absorption.• Donotuseonpatientswithknownallergiestochlorhexidinegluconateorisopropylalcohol.• Donotuseforlumbarpunctureorallowcontactwithmeninges.• Donotuseonopenskinwoundsorasgeneralskincleanser.

Warnings• WhenusingalcoholoralcoholcontainingantisepticswithpolyurethanePICCs,careshouldbetakentoavoidprolongedorexcessive

contact. Solutions should be allowed to completely dry before applying an occlusive dressing. Chlorhexidine gluconate and/or povidone iodine are the suggested antiseptics to use.

• Alcoholshouldnotbeusedtolock,soakordeclotpolyurethanePICCsbecausealcoholisknowntodegradepolyurethanecathetersovertime with repeated and prolonged exposure.

• Acetoneandpolyethyleneglycolcontainingointmentsshouldnotbeusedwithpolyurethanecatheters,asthesemaycausefailureofthedevice.

• Thisisnotarightatriumcatheter.Avoidpositioningthecathetertipintherightatrium.Placementormigrationofthecathetertipintothe right atrium may cause cardiac arrhythmia, myocardial erosion or cardiac tamponade. The risk of these complications may be more likely in neonatal patients.

• IntendedforSingleUse.DONOTREUSE.Reuseand/orrepackagingmaycreateariskofpatientoruserinfection,compromisethestructural 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.

• Afteruse,thisproductmaybeapotentialbiohazard.Handleanddiscardinaccordancewithacceptedmedicalpracticeandapplicablelocal, state and federal laws and regulations.

• Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultincatheterfailure.• Useoflumensnotmarked“PowerInjectable”forpowerinjectionofcontrastmediamaycausefailureofthecatheter.• Powerinjectormachinepressurelimitingfeaturemaynotpreventover-pressurizationofanoccludedcatheter,whichmaycausecatheter

failure.• Exceedingthemaximumpowerinjectionflowrateorsettingthepowerinjectorpressurelimitabove300psimayresultincatheterfailure

and/or catheter tip displacement.• PowerPICC* SV catheter indication for power injection of contrast media implies the catheter’s ability to withstand the procedure, but

does not imply appropriateness of the procedure for a particular patient. A suitably trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure.

• Ifthearteryisentered,withdrawtheneedleandapplymanualpressureforseveralminutes.• Placeafingerovertheorificeofthesheathtominimizethebloodlossandriskofairaspiration.Theriskofairembolismisreducedby

performingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuveruntilthecatheterisinsertedintothesheath.• Do not use the catheter if there is any evidence of mechanical damage or leaking. Damage to the catheter may lead to rupture,

fragmentation, possible embolism, and surgical removal.• Ifsignsofextravasationexist,discontinueinjections.Beginappropriatemedicalinterventionimmediately.• Thefluidlevelinthecatheterwilldropifthecatheterconnectorisheldabovethelevelofthepatient’sheartandopenedtoair.Tohelp

prevent a drop in the fluid level (allowing air entry) while changing injection caps, hold the connector below the level of the patient’s heart before removing the injection cap.

• Centralvenouspressuremonitoringshouldalwaysbeusedinconjunctionwithotherpatientassessmentmetricswhen evaluating cardiac function.• Failuretowarmcontrasttobodytemperaturepriortopowerinjectionmayresultincatheterfailure.• Donotwipethecatheterwithacetonebasedsolutionsorpolyethyleneglycolcontainingointments.Thesecandamagethe polyurethane material if used over time.

USA Only

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• Ensurethatthestylettipdoesnotextendbeyondthetrimmedendofthecatheter.Extensionofthestylettipbeyondthecatheterend, combined with kinking and excessive forces may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.

ChloraPrep* One-Step Applicator• Flammable,keepawayfromfireorflame.• Donotusewithelectrocauteryprocedures.• Forexternaluseonly.• Whenusingthisproduct,keepoutofeyes,ears,andmouth.Maycauseseriousorpermanentinjuryifpermittedto

enter and remain. If contact occurs, rinse with cold water right away and contact a physician.• Stopuseandaskadoctorifirritation,sensitization,orallergicreactionoccurs.Thesemaybesignsofaserious

condition.• Keepoutofreachofchildren.Ifswallowed,getmedicalhelporcontactapoisoncontrolcenterrightaway.

Precautions• Carefullyreadandfollowallinstructionspriortouse.• FollowUniversalPrecautionswheninsertingandmaintainingthecatheter.• Followallcontraindications,warnings,cautions,precautionsandinstructionsforallinfusates,includingcontrastmedia,asspecifiedby

their manufacturer.• Federal(USA)lawrestrictsthisdevicetosalebyorontheorderofaphysician.• Onlymedicalpractitionerslicensedbylaw,trainedandexperiencedinproperpositioningofcathetersinthecentralvenoussystemusing

percutaneous entry (Seldinger technique) should place this catheter.• Onlyqualifiedhealthcarepractitionersshouldinsert,manipulateandremovethesedevices.• The PowerPICC* SV catheter features a reverse-taper catheter design. Placement of larger catheters at or below antecubital fossa may result

in an increased incidence of phlebitis. Placement of the PowerPICC* SV catheter above antecubital fossa is recommended.• Neveruseforcetoremovethestylet.Resistancecandamagethecatheter.Ifresistanceorbunchingofthecatheterisobserved,stop

styletwithdrawalandallowthecathetertoreturntonormalshape.Withdrawboththecatheterandstylettogetherapproximately2cmandreattemptstyletremoval.Repeatthisprocedureuntilthestyletiseasilyremoved.Oncethestyletisout,advancethecatheterintothe desired position (zero mark).

• Thestyletorstiffeningwireneedstobewellbehindthepointthecatheteristobecut.NEVERcutthestyletorstiffeningwire.• Avoidplacementorsecurementofthecatheterwherekinkingmayoccur,tominimizestressonthecatheter,patencyproblemsor

patient discomfort.• Placement of larger catheters at or below antecubital fossa may result in an increased incidence of phlebitis. Placement of PICC above antecubital fossa is recommended.• If the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.• Useaseptictechniqueswheneverthecatheterlumenisopenedorconnectedtootherdevices.• Donotadvancetheguidewirepasttheaxillawithoutfluoroscopicguidance.• Tominimizetheriskofcatheterbreakageandembolization,thecathetermustbesecuredinplace.• Forbloodsamplingorbloodinfusion/administration,a20gaugeorlargercatheterlumenisrecommended.

- Blood can be safely withdrawn through the 21 gauge lumen of the 4 Fr dual-lumen PowerPICC* SV catheter, however, flow rate will be reduced compared to the 19 gauge lumen.

• Toreducepotentialforbloodbackflowintothecathetertip,alwaysremoveneedlelesscapsslowlywhileinjectingthelast0.5mLofsaline.

I. Prior to beginning placement procedure, do the following:• Examinethepackagecarefullybeforeopeningtoconfirmitsintegrityandthattheexpirationdatehasnotpassed.Thedeviceissupplied

in a sterile package and is non-pyrogenic. Do not use if package is damaged, opened or the expiration date has passed. Sterilized by ethylene oxide. Do not resterilize.

• Inspectkitforinclusionofallcomponents.• Flushthecatheterwithsterilenormalsalinepriortouse.Catheterstyletmustbewettedpriortostyletrepositioningorwithdrawal.II. To avert device damage and/or patient injury during placement:• Donotallowaccidentaldevicecontactwithsharpinstruments.Mechanicaldamagemayoccur.Useonlysmoothedged,atraumatic

clamps or forceps. • Donotperforate,tear,orfracturethecatheterwhenusingaguidewire.• Donotusethecatheterifthereisanyevidenceofmechanicaldamageorleaking.• Donotbendcatheteratsharpanglesduringimplantation.Thiscancompromisecatheterpatency.• Donotoccludeorcutcatheterwhenusingsuturestosecurecatheter.• Whenusingpeel-apartintroducers:

- Avoid blood vessel damage by maintaining a catheter or dilator as internal support when using a peel-apart introducer.- Avoid sheath damage by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.

• Donotsuturearoundthecatheterassuturesmaydamagethecatheterorcompromisecatheterpatency.• Donotcutstylet.III. After placement, observe the following precautions to avoid device damage and/or patient injury:• Warning:Do not use the device if there is any evidence of mechanical damage or leaking. Damage to the catheter may lead to rupture,

fragmentation and possible embolism and surgical removal. • Accessoriesandcomponentsusedinconjunctionwiththisdeviceshouldincorporateluerlockconnections.• Warning: If signs of extravasation exist, discontinue injections. Begin appropriate medical intervention immediately.• DONOTUSEASYRINGESMALLERTHAN10mL.Prolongedinfusionpressuregreaterthan25psimaydamagebloodvesselsorviscus.• Warning:Exceeding the maximum power injection flow rate may result in catheter failure and/or catheter tip displacement.• Forfurtherinformationorquestions,pleasecall800-443-3385or801-522-5000.

USA Only

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Possible ComplicationsThe potential exists for serious complications including the following:

• AirEmbolism• Bleeding• BrachialPlexusInjury• CardiacArrhythmia• CardiacTamponade• CatheterErosionThroughtheSkin• CatheterEmbolism• CatheterOcclusion• CatheterRelatedSepsis• Endocarditis

• ExitSiteInfection• ExitSiteNecrosis• Extravasation• FibrinSheathFormation• Hematoma• IntoleranceReactiontoImplanted

Device• LacerationofVesselsorViscus• MyocardialErosion• PerforationofVesselsorViscus

• Phlebitis• SpontaneousCatheterTipMalposition

or Retraction• Thromboembolism• VenousThrombosis• VesselErosion• RisksNormallyAssociatedwithLocal

orGeneralAnesthesia,Surgery,andPost-OperativeRecovery

Insertion Instructions1. Identify the Vein and Insertion Site• Applyatourniquetabovetheanticipatedinsertionsite.• Selectaveinbasedonpatientassessment.Recommendedveinsarebasilic,cephalicandmedian

cubital veins. Caution: Placement of larger catheters at or below antecubital fossa may result in an increased incidence of phlebitis. Placement of PICC above antecubital fossa is recommended.

Caution: Avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort. • Releasetourniquet.

2. Patient Position / Catheter Measurement • Positionthearmata90˚angle.• Forcentralplacement,therecommendedtargettiplocationisinthelower1/3oftheSuperiorVenaCava(SVC). Measure from the planned insertion site to the right clavicular head, then down to the third intercostal space. Note: External measurement can never exactly duplicate the internal venous anatomy.

3. Skin Preparation• Donprepgloves.• Applyunderdrape.• PreparethesitewiththeChloraPrep*AntimicrobialSolutionOne-StepApplicatororaccordingtoinstitutionalpolicyusing sterile technique. - Pinch the wings of the ChloraPrep*AntimicrobialSolutionOne-StepApplicatortobreaktheampuleandreleasetheantiseptic. Do not touch the sponge. -Wetthespongebyrepeatedlypressingandreleasingthespongeagainstthetreatmentareauntilfluidisvisibleontheskin. - Use repeated back-and-forth strokes of the sponge for approximately 30 seconds. Completely wet the treatment area with antiseptic.

Allow the area to dry for approximately 30 seconds. Do not blot or wipe away. - Maximum treatment area for one applicator is approximately 130 cm2 (approximately 4 x 5 in.). Discard the applicator after a single use.• Whenalcoholisusedasaskinprep,itmustbeallowedtocompletelyairdrybeforeproceedingwithinsertion.• Removeanddiscardgloves.

4. Sterile Field Preparation• Applythetourniquetabovetheintendedinsertionsitetodistendthevessel.• Donsterilegloves.• Applyfenestratedbodydrape&completesterilefieldpreparation.

5. Preflush the Catheter 1

23

45

• AttachprefilledsyringetotheluerattachmentontheT-Lockextensionset.• Preflushalllumensofcatheterwithsterilenormalsalinetowethydrophilicstylet.• Removethesyringeafterpreflushing.

6. Modification of Catheter Length Note: Catheters can be cut to length if a different length is desired due to patient size and desired

point of insertion according to hospital protocol. Catheter depth markings are in centimeters.• Measurethedistancefromthezeromarktothedesiredtiplocation.• DisconnecttheT-Lockfromthecatheterluerconnector.• WithdrawtheentireT-lockconnector/styletassemblyasoneunit.• Retract the stylet to well behind the point the catheter is to be cut.• Usingasterilescalpelorscissors,carefullycutthecatheteraccordingtoinstitutionalpolicy if necessary.• Caution: The stylet or stiffening wire needs to be well behind the point the catheter is to becut.NEVERcutthestyletorstiffeningwire.• Inspectcutsurfacetoassurethereisnoloosematerial.• Re-advancetheT-lockconnector/styletassembly.• LocktheT-Lockconnectortothecatheterhub.

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• GentlyretractthestyletthroughthelockedT-lockconnectoruntilthestylettipiscontained inside the catheter. Warning: Ensure that the stylet tip does not extend beyond the trimmed end of the catheter. Extension of the stylet tip beyond the catheter end, combined with kinking and excessive forces may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury. [See Figure 1]

7. Perform Venipuncture

• Anesthetizewithlocalanesthesiaasrequired.• Insertthesafetyintroducerneedleintothedesiredvein. Alternate Technique:ThesafetyIVcathetermaybeusedasanalternatetothesafetyintroducer needle. Remove the needle from the catheter after the vein is accessed. Warning: If the artery is entered, withdraw the needle and apply manual pressure for several minutes.• Releasetourniquet.• Removetheguidewiretipprotectorfromtheguidewirehoopandinserttheflexibleendoftheguidewire

into the introducer needle or catheter and into the vein. Advance the guidewire to the desired depth. Caution: Do not advance the guidewire past the axilla without fluoroscopic guidance.• GentlywithdrawandremovethesafetyintroducerneedleorsafetyIVcatheter,whileholdingthe guidewire in position. Caution: If the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.• Advancethesmallsheathanddilatortogetherasaunitovertheguidewire,usingaslightrotational

motion. If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator. Verifyinstitutionalguidelinesconcerningtheuseofasafetyscalpelpriortomakingincision.• Withdrawthedilatorandguidewire,leavingthesmallsheathinplace. Warning: Place a finger over the orifice of the sheath to minimize blood loss and risk of air aspiration. The risk of air embolism is reduced

byperformingthispartoftheprocedurewiththepatientperformingtheValsalvamaneuveruntilthecatheterisinsertedintothesheath.

8. Insert and Advance the Catheter • Insertthecatheterintotheintroducersheath.• Advancethecatheterslowly.Note: Resistance may be felt approximately 7 cm distal of catheter hub when introducing the catheter into the sheath due to an increase in outerdiameter(O.D.)Theintroducermaybepartiallysplit,butnotremovedtofacilitateinsertionofthecatheterpastthispointifnecessary.9. Complete Catheter Insertion• Continuetoadvancethecatheter.Forcentralplacement,whenthetiphasadvancedtotheshoulder, have the patient turn head (chin on shoulder) toward the insertion side to prevent possible insertion into the jugular vein. The PowerPICC* SV catheter features a reverse-taper catheter design.• Positionthearmata90˚angle,maintainingsterility.Completecatheteradvancementintothedesiredposition.• Note:PICCsshouldbepositionedwiththecathetertipinthelower1/3oftheSVC.Verifycorrectcathetertipposition using radiography or appropriate technology.• Warning: This is not a right atrium catheter. Avoid positioning the catheter tip in the right atrium. Placement or migration of the catheter tip into the right atrium may cause cardiac arrhythmia, myocardial erosion or cardiac tamponade. The risk of these complications may be more likely in neonatal patients.

10. Retract and Remove the Introducer Sheath• Stabilizethecatheterpositionbyapplyingpressuretotheveindistaltotheintroducersheath.• Withdrawtheintroducersheathfromtheveinandawayfromthesite.• Splittheintroducersheathandpeelitawayfromthecatheter.

11. Remove the Stylet / T-Lock Assembly • DisconnecttheT-Lockfromthecatheterluerconnector.• Stabilizethecatheterpositionbyapplyinglightpressuretotheveindistaltotheinsertionsite.• SlowlyremovetheT-Lockandstylet.• Caution:Neveruseforcetoremovethestylet.Resistancecandamagethecatheter.Ifresistanceorbunchingofthecatheterisobserved,

stopstyletwithdrawalandallowthecathetertoreturntonormalshape.Withdrawboththecatheterandstylettogetherapproximately2cmandreattemptstyletremoval.Repeatthisprocedureuntilthestyletiseasilyremoved.Oncethe stylet is out, advance the catheter into the desired position (zero mark).

12. Aspirate and Flush • Attachprimedextensionsetand/orsaline-filledsyringe.• Aspirateforadequatebloodreturnandflusheachlumenofthecathetertoensurepatency.Inaddition, lock each lumen of the catheter with heparinized saline. Usually one ml per lumen is adequate.• Caution: To reduce potential for blood backflow into the catheter tip, always remove needles or needleless caps slowly while injecting the last 0.5 mL of saline.• Capcatheter.• Warning: The fluid level in the catheter will drop if the catheter connector is held above the level of the patient’s heart and opened to air. To help prevent a drop in the fluid level (allowing air entry) while changing injection caps, hold the connector below the level of the patient’s heart before removing the injection cap.

1 cm

1 cmFigure 1 Incorrect

Correct

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13. Securing the PowerPICC* SV Catheter The StatLock* catheter stabilization device is included in PowerPICC* SV catheter kits. Please refer to Instructions For Use on the proper use and removal. The StatLock* catheter stabilization device should be monitored daily and replaced at least every seven days.• Caution: To minimize the risk of catheter breakage and embolization, the catheter must be secured in place.• Warning: WhenusingalcoholoralcoholcontainingantisepticswithpolyurethanePICCs,careshouldbetakentoavoidprolongedor

excessive contact. Solutions should be allowed to completely dry before applying an occlusive dressing. Chlorhexidine gluconate and/or povidone iodine are the suggested antiseptics to use.

• Warning: Alcohol should not be used to lock, soak or declot polyurethane PICCs because alcohol is known to degrade polyurethane catheters over time with repeated and prolonged exposure.

• Warning: Acetone and polyethylene glycol containing ointments should not be used with polyurethane catheters, as these may cause failure of the device.

The StatLock* Catheter Stabilization Device Procedure Single Lumen

1. Secure catheter with StatLock* catheter stabilization device.

2. Cover site and StatLock* catheter stabilization device with transparent dressing.

3. Place anchor tape sticky side up, under hub.Wedgetapebetween hub and wings.

4. Chevron anchor tape on top of transparent dressing.

Dual Lumen

1. Secure catheter with StatLock* catheter stabilization device.

2. Cover site and StatLock* catheter stabilization device with transparent dressing.

3. Place 1st anchor tape sticky side up, under one extension leg. Wedgetapebetweenhub and wings. Chevron anchor tape on top of transparent dressing.

4. Place 2nd anchor tape sticky side up underhub.Wedgetape between hub and wings. Chevron anchor tape on top of transparent dressing.

Tape Strip Securement Procedure

Single Lumen

1. Place 1st anchor tape over wings or bifurcation.

2. Cover site and 1st anchor tape with transparent dressing up to hub, but not over hub.

3. Place 2nd anchor tape sticky side up under hub and close to transparent dressing. Wedgetapebetweenhub and wings. Anchor only one hub of dual lumen catheter.

4. Chevron 2nd anchor tape on top of transparent dressing and place 3rd anchor tape over hub.

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Dual Lumen

1. Place 1st anchor tape over wings or bifurcation.

2. Cover site and 1st anchor tape with transparent dressing up to hub, but not over hub.

3. Place 2nd anchor tape sticky side up under hub and close to transparent dressing. Wedgetapebetweenhub and wings. Anchor only one hub of dual lumen catheter.

4. Chevron 2nd anchor tape on top of transparent dressing and place 3rd anchor tape over hub.

14.VerifyPlacement• Verifycathetertiplocationradiographicallyorwithappropriatetechnology.

Suggested Catheter MaintenanceThe catheter should be maintained in accordance with standard hospital protocols. Suggested catheter maintenance is as follows:• DressingChanges Assess the dressing in the first 24 hours for accumulation of blood, fluid or moisture beneath the dressing. During all dressing changes,

assess the external length of the catheter to determine if migration of the catheter has occurred. Periodically confirm catheter placement, tip location, patency and security of dressing.

• Flushing Flush each lumen of the catheter with 10 mL of saline every 12 hours or after each use. In addition, lock each lumen of the catheter with

heparinized saline. Usually one ml per lumen is adequate.• OccludedorPartiallyOccludedCatheter Catheters that present resistance to flushing and aspiration may be partially or completely occluded. Do not flush against resistance. If

the lumen will neither flush nor aspirate and it has been determined that the catheter is occluded with blood, a declotting procedure per institution protocol may be appropriate.

• WhenCleaningtheexitsite Warning: Do not wipe the catheter with acetone based solutions or polyethylene glycol containing ointments. These can damage the

polyurethane material if used over time. - Maintain according to hospital protocol. Avoid using acetone based solutions, or ointment. These substances are known to degrade

polyurethane.- Use chlorhexidine gluconate or povidone iodine to clean the exit site around the catheter.- Allow all cleaning agents / antiseptics to dry completely before applying dressing.

• PowerInjections The PowerPICC* SV catheter testing included 10 power injection cycles.

Central Venous Pressure Monitoring• Priortoconductingcentralvenouspressuremonitoring: - Ensure proper positioning of the catheter tip. - Flush catheter vigorously with sterile normal saline. - Ensure the pressure transducer is at the level of the right atrium.• Itisrecommendedthatacontinuousinfusionofsaline(3ml/hr)ismaintainedthroughthecatheterwhilemeasuringCVPtoimprove accuracyofCVPresults.• Useyourinstitution’sprotocolsforcentralvenouspressuremonitoringprocedures.• Warning: Central venous pressure monitoring should always be used in conjunction with other patient assessment metrics when evaluating cardiac function.

Catheter Removal• Removedressing,andStatLock* catheter stabilization device or tape securement strips.• Graspcatheternearinsertionsite.• Removeslowly.Donotuseexcessiveforce.• Ifresistanceisfelt,stopremoval.Applywarmcompressandwait20-30minutes.• Resumeremovalprocedure.