Post on 02-Jan-2017
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