DESCRIPTION:•TheEZ-IO®PowerDriverisasealed,hand-held,lithiumbatterypoweredmedicaldevice.

PRODUCT INFORMATION:•DriverRef.numbers:9040(Tactical);9058(Civilian);9059(Training).

•AppliedParts:EZ-IO®IntraosseousVascularAccessNeedles–15mm;25mm;45mm.

SAFETY INFORMATION:•Indications,contraindications,warnings,precautions,andothersafetyinformationarecontainedintheInstructionsforUsefortheEZ-IO®IntraosseousVascularAccessSystem.

•PleaseconsulttheInstructionsforUsefortheEZ-IO®IntraosseousVascularAccessSystembeforeapplying.Iftherearequestions,orifthisinformationsheetismissing,immediatelycontactyourlocalTeleflexsalesrepresentative.

•AdditionalproductinformationcanbefoundatEZ-IOaccess.com.•Aswithanyemergencymedicaldevicecarryingabackupisastronglyadvisedprotocol.

IMPORTANT INFORMATION FOR USERS: InorderforEZ-IO®IntraosseousVascularAccessSystemproductstoperformproperly,thefollowingconditionsarerecommended.Failuretocomplywiththeseconditionswillvoidanyapplicablewarranties.•Usethisproductonlyinaccordancewiththismanualandapplicableproductlabeling.•Adjustments,modifications,technicalmaintenanceorrepairsarenotallowed.•DonotconnectthisproductoritscomponentstoproductsnotrecommendedbyTeleflex.•UseonlyEZ-IO®IntraosseousVascularAccessneedlesetswiththisproduct.•Visuallyinspectdriverforcracksandsharpcornersbeforeuse.•Avoidspillingfluidsonanypartofthisproduct.•Donotuseexcessiveforceduringinsertion.LettheEZ-IO®PowerDriverdothework.

STORAGE: •TheEZ-IO®PowerDriverandaccessoriesmaybestoredattemperaturesbetween-20°Cto50°C(-4°Fto122°F).

•ExpectedshelflifefortheEZ-IO®PowerDriveris10yearsorapproximately500insertions.

•Lifeexpectancyisdependentonactualusage(bonedensityandaverageinsertiontime),storage,andfrequencyoftesting.

•WhenstoringtheVascularAccessPak(VAP)removethetriggerguardtopreventaccidentalactivationoftheEZ-IO®PowerDriver.

BatteryIndicator

LanyardAttachmentPoint

DriveShaft

BODY

TRIGGER

SEALEDLITHIUMBATTERIES

BATTERY INFORMATION:•Driversaresealedandnotintendedtobeopened.•Batteriesarenotreplaceable.

INDICATORS & ALERTS:•EZ-IO®PowerDriverLEDwillbesolidgreenwhentriggerisactivatedandhassufficientpower.•EZ-IO®PowerDriverLEDwillblinkredwhenthetriggerisactivatedandhasonly10%ofbatteryliferemaining.

•PurchaseandreplacetheEZ-IO®PowerDriverwhentheredLEDbeginsblinking.

CARE AND CLEANING:1. MaintainBSIorPPEprecautions.

2. WipeentireexteriorsurfaceofEZ-IO®PowerDriverwithsoft,cleanmoistenedcloth.Usesoftbristledbrushtoremoveanyvisiblesoil.

3. Sprayexteriorsurfacewithanti-microbialsolutionfollowingthesolutionmanufacturer’sspecificrecommendations.

4. Gentlywipeexteriorsurfaceswithgauzepadsuntilvisibledebrisisremoved.

5. Cleanandmanipulatetriggerusingclothmoistenedwithanti-microbialsolution.

6. Usingsterileswabs,moistenwithanti-microbialsolution,gentlycleaninsideopeningaroundmetaldriveshaft.

7. Aftercleaning,inspecttoensurenovisibledebrisremains,andnodamagehasoccurred.

8. Drydriverwithasoft,cleanclothandreturntoappropriatelocation.

Donotimmerseoruseexcessiveamountofliquidwhenperformingcleaninganddisinfecting.Intheunlikelyeventofadriverfailure,removetheEZ-IO®PowerDriver,grasptheneedlesetbyhand,andadvancetheneedlesetintothemedullaryspacewhiletwistingtheneedleset.

Ifyourclinicalenvironmentrequiressterilization,theEZ-IO®PowerDrivercanbesterilizedusingtheSTERRAD®100SSystem,NX®System,and100NX®System.STERRAD®Systemsareproductsof©ADVANCEDSTERILIZATIONPRODUCTS,DivisionofEthiconInc.,aJohnson&Johnsoncompany.

WARNING:Nomodificationofthisequipmentisallowed.

Product InformatIon

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Product InformatIon EZIOaccess.com

EMERGENCY NUMBER:

1.800.680.4911

CustomerService:1.866.479.8500

© 2014 Vidacare LLC , all rights reserved. Arrow®, EZ-IO Intraosseous Vascular System®, EZ-Stabilizer™, and EZ-Connect® are trademarks of Teleflex Inc.

ECREP

EuropeanAuthorizedRepresentativeService

DegreeofprotectionagainstelectricshockBFAppliedpart.

ConsultInstructionsForUse

C

4001639 SerialNumberSN

AtthecompletionofthePowerDriver’sservicelife,properdisposalistheresponsibilityoftheinstitutionorservice(directive2012/19/EU).

TheSystemConformstotheMedicalDeviceDirective(93/42/EEC)

EMERGOEUROPE

Molenstrat152513BH,TheHague

Netherlands

AUSTRALIANSPONSOR

EmergoAustraliaLevel20,TowerIIDarlingPark

201SussexStreetSydneyNSW2000

Australia

VIDACARELLC

4350LockhillSelmaRoad,Suite150ShavanoPark,TX78249

UnitedStates

Thisdeviceisrestrictedforsalebyoronorderofaphysician.

8047RevD(07/2014)

INTRAOSSEOUS VASCULAR ACCESS

EZ-IOINTRAOSSEOUS VASCULAR ACCESS

EZ-IO

Instructions for Use

EZ-IO®

POWER DRIVER

VIDACARE LIMITED EXPRESS WARRANTY AND DISCLAIMERS

Vidacarewarrants to theoriginalenduserof theProductsonly (“End User”) thatduring theapplicableWarrantyPeriod:(a)thehardwareProductswillconformwithVidacare’swrittenproductspecificationsforsuchProductsinallmaterialrespectsfortheshorterof(i)oneyearaftershipmenttoEndUseror(ii)thenumberofusesofsuchhardwareProductasarespecifiedbyVidacareinitswrittenproductspecifications,and(b)thedisposableProductswillconformwithVidacare’swrittenproductspecificationsforsuchProductsinallmaterialrespectsuntiltheexpirationdatedesignatedthereforonsuchdisposableProducts(collectively,the“Warranty Period”),unlesstheProductshavebeensubjectedtophysicalabuse,misuse,abnormaluse,usenotconsistentwith Vidacare’s published directions and instructions for use, fraud, tampering, unusual physical stress,negligenceoraccidents(“Express Warranty”).VidacaredoesnotguaranteethattheoperationofahardwareProductwillbeuninterruptedorerror-free.Vidacarewill,initsdiscretion,repair,replaceorrefundthepurchasepricetoEndUserforProductdeterminedbyVidacaretobenon-conforming(“Remedies”),providedthatEndUser returnsthenonconformingProducttoVidacareduringtheapplicableWarrantyPeriod,atEndUser’sexpense and first gives promptwritten notice to Vidacare so that Vidacare can issue a ReturnMaterialAuthorization (“RMA”)number. Products sent toVidacare forwarranty replacementwithout a validRMAnumberdisplayedontheoutsideoftheshippingcontainermay,inVidacare’sdiscretion,bereturnedtoEndUseratEndUser’sexpense.AllreturnednonconformingProductbecomethepropertyofVidacare.Totheextentpermittedbylaw,VidacaremayrepairorreplacenonconforminghardwareProducts(a)withneworpreviouslyusedProductsorpartsequivalenttonewinperformanceandreliability,or(b)withequivalentProductstoanoriginalProductthathasbeendiscontinued.ReplacementProducts(orpartsthereof)arewarrantedfortheremainderoftheWarrantyPeriodoftheProducttheyarereplacing.THEREMEDIESDESCRIBEDHEREINSHALLBEENDUSER’SSOLEANDEXCLUSIVEREMEDYFORAFAILUREOFAPRODUCTTOCONFORMTOTHEEXPRESSWARRANTY.TOTHEMAXIMUMEXTENTPERMITTEDBYAPPLICABLELAW,THEEXPRESSWARRANTYISTHESOLEANDEXCLUSIVEWARRANTYANDGIVENINLIEUOFALLOTHERWARRANTIES,WHETHEREXPRESS,IMPLIEDORSTATUTORY, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY OR SUITABILITY. IF THEDISCLAIMEROFANYIMPLIEDWARRANTYISNOTPERMITTEDBYAPPLICABLELAW,SUCHEXPRESSWARRANTYIS LIMITED TO NINETY (90) DAYS FROM THE DATE OF ORIGINAL PURCHASE. OTHER THAN THE EXPRESSWARRANTY, THE PRODUCTS ARE PROVIDED “AS IS” AND ARE DESIGNED FOR USE SOLELY BY QUALIFIEDHEALTHCAREPERSONNELUSINGREASONABLEMEDICALDISCRETIONINMEDICALLYNECESSARYSITUATIONS.VIDACARE DISCLAIMS ALL LIABILITYWITH RESPECT TO THE PRODUCTS ARISING FROM ANY USE OF THEPRODUCTSTHATISINCONSISTENTWITHVIDACARE’SPUBLISHEDDIRECTIONSANDINSTRUCTIONSFORUSE.INNOEVENTSHALLVIDACAREBELIABLETOENDUSER,ANYCUSTOMERORANYOTHERTHIRDPARTY(“CLAIMANT”)INANYMANNERFORANYSPECIAL,NON-COMPENSATORY,CONSEQUENTIAL,INDIRECT,INCIDENTAL,STATUTORYOR PUNITIVE DAMAGES OF ANY KIND, WHETHER ARISING UNDER CONTRACT OR TORT LAW (INCLUDINGNEGLIGENCEANDSTRICTPRODUCTLIABILITY),REGARDLESSOFTHEFORMOFLEGALACTIONEVENIFVIDACAREISAWAREOFTHEPOSSIBILITYOFANYSUCHDAMAGESINADVANCE.VIDACARE’STOTALAGGREGATELIABILITYINCONNECTIONWITHTHEPURCHASEORUSEOFTHEPRODUCTSSHALLNOTEXCEEDTHESUMOFTHEAMOUNTSPAIDBYCLAIMANTTOVIDACAREDURINGTHETWELVE(12)MONTHSIMMEDIATELYPRECEDINGTHEDATEOFTHEEVENTGIVINGRISETOACLAIMAGAINSTVIDACARE.

Declarations – Electromagnetic Immunity

TheEZ-IO®PowerDriverisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheEZ-IO®PowerDrivershouldassurethatitisissuedinsuchanenvironment.

Immunitytest IEC60601testlevel ComplianceLevel ElectromagneticEnvironment-Guidance

Electrostaticdischarge(ESD)IEC61000-4-2

+/-6kVContact+/-8kVair

+/-6kVContact+/-8kVair

Floorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterialtherelativehumidityshouldbeatleast30%.

ElectricalfastTransient/burstIEC61000-4-4

+/-2kVforpowersupplylines+/-1kVforinput.outputlines

Notapplicable(batterypowered)Notapplicable(noI/Olines)

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

SurgeIEC61000-4-5

+/-1kVdifferentialmode+/-2kVcommonmode

Notapplicable(batterypowered)

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Voltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlinesIEC61000-4-11

<5%Ur(>95%dipinUr)for0.5cycles40%Ur(60%dipinUr)for5cycles70%Ur(30%dipinUr)for25cycles<5%Ur(95%dipinUr)for5sec

Notapplicable(batterypowered)

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.IftheuseroftheEZ-IO®PowerDriverrequirescontinuedoperationduringpowermainsinterruptions,itisrecommendedthatthepowerdriverbepoweredfromanuninterruptiblepowersupplyorabattery.

Powerfrequency(50/60Hz)magneticfieldIEC61000-4-8

3A/m 3A/m

Powerfrequencymagneticfieldsshouldbeatlevelscharacteristicoftypicallocationintypicalcommercialorhospitalenviroment.

NOTE:Uristhea.c.mainsvoltagepriortoapplicationofthetestlevel.

Guidance and Manufacturer’s Declaration — Electromagnetic Immunity

TheEZ-IO®PowerDriverisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheEZ-IO®PowerDrivershouldassurethatitisusedinsuchanenvironment.

Immunity test IEC 60601 test level

Compliance Level

Electromagnetic environment — guidance

ConductedRFIEC61000-4-6RadiatedRFIEC61000-4-3

3Vrms150kHzto80MHz3V/m80MHzto2,5GHz

Notapplicable(batterypowered)3V/m

PortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartofthedriverincludingcables,thantherecommendedseparationdistancecalculatedfromtheequationapplicabletothefrequencyofthetransmitter.Recommendedseparationdistanced = 3,5 P V1

d = 3,5 P E1

d = 7 P E1

wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherecommendedseparationdistanceinmeters(m).FieldstrengthsfromfixedRFtransmittersasdeterminedbyanelectromagneticsitesurvey,ashouldbelessthanthecompliancelevelineachfrequencyrange.bInterferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objects,andpeople.

aFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmittersanelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheEZ-IO®PowerDriverisusedexceedstheapplicableRFcompliancelevelabove,theEZ-IO®PowerDrivershouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasre-orientingorrelocatingtheEZ-IO®PowerDriver.bOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

Recommended separation distances between portable and mobile RF communications equipment and the EZ-IO® Power Driver

TheEZ-IO®PowerDriverisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheEZ-IO®PowerDrivercanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andtheEZ-IO®PowerDriverrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

Ratedmaximumoutputpowerof

transmitterW

Separationdistanceaccordingtofrequencyoftransmitterm

150kHzto80MHzd = 3,5 P V1

80MHzto800MHzd = 3,5 P E1

800MHzto2,5GHzd = 7 P E1

.01 0.12 0.12 0.23.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmeters(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter;wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.

NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objects,andpeople.

•MedicalelectricalequipmentneedsspecialprecautionsregardingEMCandneedstobeinstalledandputintoserviceaccordinglytotheEMCinformationprovidedinthismanual.

•PortableandmobileRFcommunicationscanaffectmedicalelectricalequipment.•Theuseofaccessories,transducers,andcablesotherthanthosespecifiedbythemanufacturer,mayresultinincreasedemissionsordecreasedimmunityoftheEZ-IO®PowerDriver.

•TheEZ-IO®PowerDrivershouldbeobservedtoverifynormaloperationintheconfigurationitwillbeused.

•TheEZ-IO®PowerDriverisdesignedandtestedtorunintermittentlywithadutycycleof30secondson,1minuteofffor5consecutivecycles.Allow1hourcooldowntime.

Equipment ClassificationTypeofprotectionagainstelectricshock NAinternalpoweredequipment

Degreeofprotectionagainstelectricshock TypeBFappliedpart

Degreeofprotectionagainstingressofwater IPXOOrdinaryprotection

Degreeofsafetyorapplicationinthepresenceofaflammableanestheticmixture

Equipmentnotsuitableforuseinthepresenceofaflammableanestheticmixturewithairorwithoxygenornitrousoxide

Declaration-Electromagnetic Emissions

TheEZ-IO®PowerDriverisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheEZ-IO®PowerDrivershouldassurethatitisissuedinsuchanenvironment.

Emission Test Compliance Compliance

RFEmissionsCISPR11 Group 1

TheEZ-IO®PowerDriverusesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsareverylowandarenotlikelytocauseinterferenceinnearbyelectronicequipment.

RFEmissionsCISPR11 Class B TheEZ-IO®PowerDriverissuitableforuseinallestablishments,includingdomesticestablishmentsandthosedirectlyconnectedtothepubliclowvoltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.

HarmonicemissionsIEC61000-3-2

Not applicable

Voltagefluctuations/flickeremissionsIEC61000-3-3

Not applicable

Warranty InformatIon

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INTRAOSSEOUS VASCULAR ACCESS

EZ-IO