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Instructions for Use

T.A.L.O.N.TM 7-SITE INTRAOSSEOUS

SYSTEM

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DESCRIPTION:T.A.L.O.N.TM(TacticallyAdvancedLifesavingIntraosseousNeedle)7-SiteIntraosseousSystemcontainsanEZ-IO®ManualNeedleSetandasternallocator.WhenthestyletisremovedthecatheterLuerLockisexposed.Thecatheteris15gauge,38.5mm,madeof304stainlesssteelandprovidedsterile,non-pyrogenicinasealedkit.DeviceandComponent(s)is/arenotmadewithnaturalrubberlatex.

EACH T.A.L.O.N.TM KIT CONTAINS: • 1EZ-IO®ManualNeedleSet • 1EZ-Connect® • 1SternalLocator • 1InstructionsforUse • 1NeedleVise® • 1EZ-IO®WristbandINDICATIONS FOR USE: FOR INTRAOSSEOUS (IO) ACCESS IN ADULT PATIENTS WHEN RAPID FLUID OR PHARMACOLOGICAL RESUSCITATION IS REQUIRED IN EMERGENCIES: • Sternum • ProximalHumerus • ProximalTibia • DistalTibia

CONTRAINDICATIONS FOR USE: • Fracture • Infectionattheareaofinsertion • Excessivetissue(severeobesity)and/or • Previous,significantorthopedicprocedureat absenceofadequateanatomicallandmarks thesite,prostheticlimborjoint • Osteoporosis(sternalapplicationonly) • IOatsiteinthepast48hours WARNINGS AND PRECAUTIONS:WARNING:Sternallocatorshouldnotbeusedinthefollowingsites: • ProximalHumerus,ProximalTibiaorDistalTibia

CAUTION: DONOTUSEtheManualNeedleSetinthesternumWITHOUTthesternallocator.CAUTION: Beforeadministeringvesicant,toxic,orhighly-concentrateddrugs,checktheManualNeedleSetagain forplacementandpatency.CAUTION: Useaseptictechnique.CAUTION: (SternalSite)Usewithextremecautioninpatientswithsuspectedthoracictraumasuchasairbag deploymenttothechestorchestimpactswithsteeringwheel.CAUTION: 24houruseonly.CAUTION: Singleuseonly.CAUTION: DONOTrecapNeedleSetsorseparatedcomponents. Usebiohazardandsharpsdisposalprecautions. Re-useofcontentsmaycausecrosscontamination,leadingtopatientriskandcomplication(s).CAUTION: CheckskinthicknessbeforeManualNeedleSetinsertiononallpatients(SeeFigure20).Special cautionmustbeexercisedinusewithpatientswithBMIgreaterthan30.SternalLocatorprobes shouldrestfirmlyonthemanubrialsurfacepriortoManualNeedleSetinsertion.ManualNeedleSet cannotbeusedinthesternumiftheprobesdonotseatonthebone.CAUTION: StyletandcatheterarenotMRIcompatible.

STORAGE: -18Cto48C(0°Fto120°F).

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T.A.L.O.N.TM SYSTEM COMPONENTS

A SternalLocator2 Tab13 AdhesiveTape4 LocatorHub5 Tab26 NeedleCap

Sternal Locator:

Pull1

Pull2

1

5

4

3

2

A ManualHandle2 Stylet3 Catheter4 NeedleCap

Manual Needle Set:

Pull1

Pull2

1

2

3

4

6

Pull1

Pull2

4

STERNAL INSERTION STEPS:

WARNING:ThesternallocatorMUSTbeusedwhenplacingtheManualNeedleSetintothesternum.

1. Take appropriate Body Substance Isolation (BSI) Precautions.

2. Useaseptic technique.

3. Locate insertion site.(SeeFigures1and2)

4. Prepare insertion site. (SeeFigure2forproperlocatororientation)

5. Prepare infusion system.Priortoattaching EZ-Connect®performthefollowingsteps:

a.Openclamp.

b.Attachfemaleadaptertosyringeor IVtubing.

c.PrimeEZ-Connect®withsalineor2% preservativefreelidocaineandpurgeair.

6. Remove sternal locator needle cap and pull tab 1.(SeeFigure3)

FIGURE 1

Pull1

Pull2

FIGURE 2

Pull1

Pull2

FIGURE 3

5

7. Align curve in top of sternal locator with the suprasternal notch. (SeeFigure4)

8. Seat the depth probes of the sternal locator on the surface of the sternum by pressing down firmly with both hands. (SeeFigure5)

9.Firmly press down adhesive tape.

10.Holding the sternal locator in place, pull tab 2 to expose the adhesive on the bottom half of the sternal locator.(SeeFigure6)

11.Firmly press down remaining adhesive tape.

FIGURE 4

Pull2

Pull2

FIGURE 6FIGURE 7

Pull2

FIGURE 5

6

12.Remove and discard Needle Set safety cap.(SeeFigure8)

IMPORTANT:DonottouchtheNeedleSetwithyourhandorfingers.

IMPORTANT:Controlthepatient’smovement.

IMPORTANT:Ensurestyletistightlyscrewedtogetherwithcatheterpriortoinsertion.

13.Insert. a.InsertNeedleSettipintoconeatthe centeroftheSternalLocatorwith needleata90-degreeangletothe bone.(SeeFigures9and10)

b.GentlyinsertNeedleSetuntil itseatsonbone.

c.Penetratebonecortexby rotatingclockwisewhileapplying gentle, steady downward pressure. (10-15lbs,5-7kgs)

FIGURE 10

FIGURE 8

FIGURE 9

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d.Stopinsertionprocessupon entryintothemedullaryspace andaclickisfeltorheardasthe NeedleSethublocksintotheSternal Locatorhub.(SeeFigures10and11)

e.DonotrockorbendduringManual NeedleSetinsertion.MAINTAIN 90-DEGREE ANGLE.

14.Remove styletandplaceinto NeedleVise®forsharpscontainment. (SeeFigure12)

FIGURE 11

FIGURE 12

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15.Attach primed EZ-Connect® and tighten. a.Attachmaleadaptertoaccessdevice withafirmpushandtwistmotion.

b.EngageLuerLockcollarinorderto preventaccidentaldisconnection. (SeeFigure13)16.Flush the EZ-IO® catheter with 5-10 ml of Normal Saline.(SeeFigure14)

IMPORTANT: a.Priortoflushconsidertheaspiration ofasmallamountofbloodto confirmplacement.

b.For patients responsive to pain consider 2% lidocaine without preservatives or epinephrine (cardiac lidocaine) administered slowly IO prior to flush. Follow institutional policy/procedure.

c.Medicationsintendedtoremaininthe medullaryspace,suchasalocalanesthetic, mustbeadministeredover2minutes untilthedesiredeffectisachieved.

NO FLUSH = NO FLOWFailuretoappropriatelyflushtheEZ-IO®cathetermayresultinlimitedornoflow.

FIGURE 14

FIGURE 13

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REPEAT FLUSH AS NEEDEDOnceEZ-IO®catheterhasbeenflushed,administerfluidsormedicationsusingpressureasindicated.(SeeFigure15)

NOTE:Frequentlymonitortheinsertionsiteforextravasation.

NOTE: HoldT.A.L.O.N.TMSystemcomponentsfirmlyinplaceonpatientduringtransfertopatienttransportsystems.

17.CATHETER REMOVAL: a.Peelbacksternallocatoradhesivetape fromthechest.

b.AttachLuerLocksyringe.

c.Continuouslyrotateclockwisethe syringeandcatheter(notthesternal locator)whileslowlyandgently applyingtractiontothecatheter. (Seefigure16)

DO NOT ROCK OR BEND THE CATHETER DURING REMOVAL.

Onceremoved,immediatelyplacecatheterandsternallocatorinappropriatesharpscontainer.

FIGURE 15

FIGURE 16

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MANUAL USE:DEVICE DESCRIPTION:EZ-IO®ManualNeedleSetscontainastyletandacatheter.WhenthestyletisremovedthecatheterLuerLockisexposed.Thecatheteris15gauge,38.5mm,madeof304stainlesssteelandprovidedsterile,non-pyrogenicinasealedkit.DeviceandComponent(s)is/arenotmadewithnaturalrubberlatex.

A ManualHandle2 Stylet3 Catheter4 NeedleCap

Manual Needle Set:Pull

1

Pull2

1

2

3

4

11

INSERTION STEPS:

1. Take appropriate Body Substance Isolation (BSI) Precautions.

2. Use aseptic technique.

3. Locate insertion site.(SeeFigure17)

4. Prepare insertion site. (SeeFigure18–Tibialsiteshown forclarity)

5. Prepare infusion system. 6. Remove and discard the Needle Set safety cap.

FIGURE 17

FIGURE 18

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7. Insert. (SeeFigure19)

IMPORTANT: Donottouchthecatheterwithyourhandorfingers.

IMPORTANT: Controlthepatient’smovementpriortoandduringNeedleSetinsertion.

IMPORTANT: Ensurestyletistightlyscrewedtogetherwithcatheterpriortoinsertion. a.Positionmanualdriveratinsertion sitewithNeedleSetata90-degree angletotheskin.(SeeFigure19) GentlyinsertNeedleSetuntil NeedleSettiptouchesbone. b.Ensureatleast5mmofcatheteris visible.(SeeFigure20) c.Penetratebonecortexbyrotating clockwisewhileapplyinggentle, steady downward pressure.

d.Stopinsertionprocesswhenadesired depthisobtainedorcatheterhubis flushedwiththeskin. e.DonotrockorbendduringNeedleSet insertion.MAINTAIN 90° ANGLE.

FIGURE 19

5 mm

FIGURE 20

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IMPORTANT: Use gentle-steady pressure – not excessive force. Allow catheter tip rotation and gentle downward pressure to provide penetrating action.

8. Remove styletandplacein NeedleVise®forsharpscontainment. (SeeFigure21)

9. Confirm catheter stability. Cathetershouldbestabilizedto preventdislodgement.

10. Attach primed EZ-Connect® extension set to Catheter Hub’s Luer Lock.

DO NOT ATTACH A SYRINGE DIRECTLY TO THE EZ-IO® CATHETER HUB’S LUER LOCK.

11. Flush the EZ-IO® catheter with 5-10 ml of Normal Saline. (SeeFigure22)

FIGURE 22

FIGURE 21

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FIGURE 23

IMPORTANT:Priortoflush,aspirateasmallamountofbloodtoconfirmplacement.

a. Consider IO lidocaine (preservation free) for conscious patients prior to flush.

b.NO FLUSH = NO FLOW Failuretoappropriatelyflush theIOcathetermayresultin limitedornoflow.Repeatflush asneeded.

c. OnceIOcatheterhasbeen flushed,administerfluidsor medicationsasindicated.

NOTE: Frequentlymonitortheinsertionsiteforextravasation.

NOTE: HoldT.A.L.O.N.TMSystemcomponentsfirmlyinplaceonpatientduringtransfertopatienttransportsystems.

12. Apply dressing.

13. Remove catheter from patient. Gentlytwistclockwisewhileslowly applyingtractiontocatheter. DO NOT ROCK OR BEND THE CATHETER DURING THIS PROCEDURE. (SeeFigure23)

Onceremoved,immediatelyplacecatheterinappropriatesharpscontainer.

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NOTES:

EducationandtrainingmaterialsavailableatVidacare.com.

CAUTION: Do not leave the catheter inserted for longer than 24 hours.

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