Teleflex Arrow EZ-IO User manual

DESCRIPTION:
•TheEZ-IO®PowerDriverisasealed,
hand-held,lithiumbatterypowered
medicaldevice.
PRODUCT INFORMATION:
•DriverRef.numbers:9040(Tactical);9058(Civilian).
•AppliedParts:EZ-IO®IntraosseousVascular
AccessNeedles–15mm;25mm;45mm.
SAFETY INFORMATION:
•Indications,contraindications,warnings,precautions,andothersafetyinformationare
containedintheInstructionsforUsefortheEZ-IO®IntraosseousVascularAccessSystem.
•PleaseconsulttheInstructionsforUsefortheEZ-IO®IntraosseousVascularAccess
Systembeforeapplying.Iftherearequestions,orifthisinformationsheetismissing,
immediatelycontactyourlocalTeleexsalesrepresentative.
•AdditionalproductinformationcanbefoundatArrowEZIO.com.
•Aswithanyemergencymedicaldevicecarryingabackupisastronglyadvisedprotocol.
IMPORTANT INFORMATION FOR USERS:
InorderforEZ-IO®IntraosseousVascularAccessSystemproductstoperformproperly,the
followingconditionsarerecommended.Failuretocomplywiththeseconditionswillvoidany
applicablewarranties.
•Usethisproductonlyinaccordancewiththismanualandapplicableproductlabeling.
•Adjustments,modications,technicalmaintenanceorrepairsarenotallowed.
•DonotconnectthisproductoritscomponentstoproductsnotrecommendedbyTeleex.
•UseonlyEZ-IO®IntraosseousVascularAccessneedlesetswiththisproduct.
•Visuallyinspectdriverforcracksandsharpcornersbeforeuse.
•Avoidspillinguidsonanypartofthisproduct.
•Donotuseexcessiveforceduringinsertion.LettheEZ-IO®PowerDriverdothework.
STORAGE:
•TheEZ-IO®PowerDriverandaccessoriesmaybestoredattemperaturesbetween
-20°Cto50°C(-4°Fto122°F).
•ExpectedshelflifefortheEZ-IO®PowerDriveris10yearsorapproximately
500insertions.
•Lifeexpectancyisdependentonactualusage(bonedensityandaverageinsertion
time),storage,andfrequencyoftesting.
•WhenstoringtheVascularAccessPak(VAP)removethetriggerguardtoprevent
accidentalactivationoftheEZ-IO®PowerDriver.
Battery
Indicator
Lanyard
Attachment
Point
Drive
Shaft
BODY
TRIGGER
SEALED
LITHIUM
BATTERIES
BATTERY INFORMATION:
•Driversaresealedandnotintendedtobeopened.
•Batteriesarenotreplaceable.
INDICATORS & ALERTS:
•EZ-IO®PowerDriverLEDwillbesolidgreenwhentriggerisactivatedandhassufcientpower.
•EZ-IO®PowerDriverLEDwillblinkredwhenthetriggerisactivatedandhasonly10%of
batteryliferemaining.
•PurchaseandreplacetheEZ-IO®PowerDriverwhentheredLEDbeginsblinking.
CARE AND CLEANING:
1. MaintainBSIorPPEprecautions.
2. WipeentireexteriorsurfaceofEZ-IO®PowerDriverwithsoft,cleanmoistenedcloth.Usesoft
bristledbrushtoremoveanyvisiblesoil.
3. Sprayexteriorsurfacewithanti-microbialsolutionfollowingthesolutionmanufacturer’s
specicrecommendations.
4. Gentlywipeexteriorsurfaceswithgauzepadsuntilvisibledebrisisremoved.
5. Cleanandmanipulatetriggerusingclothmoistenedwithanti-microbialsolution.
6. Usingsterileswabs,moistenwithanti-microbialsolution,gentlycleaninsideopeningaround
metaldriveshaft.
7. Aftercleaning,inspecttoensurenovisibledebrisremains,andnodamagehasoccurred.
8. Drydriverwithasoft,cleanclothandreturntoappropriatelocation.
Donotimmerseoruseexcessiveamountofliquidwhenperformingcleaninganddisinfecting.
Intheunlikelyeventofadriverfailure,removetheEZ-IO®PowerDriver,grasptheneedlesetby
hand,andadvancetheneedlesetintothemedullaryspacewhiletwistingtheneedleset.
Ifyourclinicalenvironmentrequiressterilization,theEZ-IO®PowerDrivercanbesterilized
usingtheSTERRAD®100SSystem.STERRAD®Systemsareproductsof©ADVANCEDSTERILIZATION
PRODUCTS,DivisionofEthiconInc.,aJohnson&Johnsoncompany.
WARNING:Nomodicationofthisequipmentisallowed.
Product InformatIon
Product InformatIon ArrowEZIO.com
EMERGENCY NUMBER:
1.800.680.4911
CustomerService:1.866.479.8500
©2014 all rights reserved. Arrow®, EZ-IO Intraosseous Vascular System®,
EZ-Stabilizer™, and EZ-Connect® are trademarks of Teleflex Inc.
Degreeofprotection
againstelectricshock
BFAppliedpart.
ConsultInstructions
ForUse
4001639 SerialNumber
SN
Atthecompletionofthe
PowerDriver’sservice
life,properdisposalis
theresponsibilityofthe
institutionorservice
(directive2012/19/EU).
TheSystemConforms
totheMedicalDevice
Directive(93/42/EEC)
Manufacturedfor:
TeleexMedical
IDABusiness&TechnologyPark,
DublinRd,Athlone,
Co.Westmeath,Ireland
Thisdeviceisrestricted
forsalebyoronorder
ofaphysician.
8047Rev05(06/2015)
INTRAOSSEOUS VASCULAR ACCESS
EZ-IO
INTRAOSSEOUS VASCULAR ACCESS
EZ-IO
Instructions for Use
EZ-IO®
POWER DRIVER

TELEFLEX LIMITED EXPRESS WARRANTY AND DISCLAIMERS
TeleexwarrantstotheoriginalenduseroftheProductsonly(“End User”)thatduringtheapplicableWarranty
Period:(a)thehardwareProductswillconformwithTeleex’swrittenproductspecicationsforsuchProducts
inallmaterialrespectsfortheshorterof(i)oneyearaftershipmenttoEndUseror(ii)thenumberofusesof
suchhardwareProductasarespeciedbyTeleexinitswrittenproductspecications,and(b)thedisposable
ProductswillconformwithTeleex’swrittenproductspecicationsforsuchProductsinallmaterialrespects
until the expiration date designated therefor on such disposable Products (collectively, the “Warranty
Period”),unlesstheProductshavebeensubjectedtophysicalabuse,misuse,abnormaluse,usenotconsistent
with Teleex’s published directions and instructions for use, fraud, tampering, unusual physical stress,
negligenceoraccidents(“Express Warranty”).Teleexdoesnotguaranteethattheoperationofahardware
Productwillbeuninterruptedorerror-free.Teleexwill,initsdiscretion,repair,replaceorrefundthepurchase
pricetoEndUserforProductdeterminedbyTeleextobenon-conforming(“Remedies”),providedthatEnd
User returns the nonconforming Product to Teleex during the applicable Warranty Period, at End User’s
expense and rst gives prompt written notice to Teleex so that Teleex can issue a Return Material
Authorization(“RMA”)number.ProductssenttoTeleexforwarrantyreplacementwithoutavalidRMAnumber
displayedontheoutsideoftheshippingcontainermay,inTeleex’sdiscretion,bereturnedtoEndUseratEnd
User’sexpense.AllreturnednonconformingProductbecomethepropertyofTeleex.Totheextentpermitted
by law,Teleex may repair or replacenonconforming hardwareProducts (a) with new or previously used
Productsor parts equivalent to new in performanceand reliability, or (b) with equivalent Productsto an
originalProductthathasbeendiscontinued.ReplacementProducts(orpartsthereof)arewarrantedforthe
remainderoftheWarrantyPeriodoftheProducttheyarereplacing.THEREMEDIESDESCRIBEDHEREINSHALL
BEENDUSER’S SOLE AND EXCLUSIVEREMEDYFOR A FAILURE OF APRODUCTTOCONFORM TOTHEEXPRESS
WARRANTY.TOTHEMAXIMUMEXTENTPERMITTEDBYAPPLICABLELAW,THEEXPRESSWARRANTYISTHESOLE
ANDEXCLUSIVEWARRANTYANDGIVENINLIEUOFALLOTHERWARRANTIES,WHETHEREXPRESS,IMPLIEDOR
STATUTORY, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-
INFRINGEMENT, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY OR SUITABILITY. IF THE
DISCLAIMEROFANYIMPLIEDWARRANTYISNOTPERMITTEDBYAPPLICABLELAW,SUCHEXPRESSWARRANTY
IS LIMITED TO NINETY (90) DAYS FROM THE DATE OF ORIGINAL PURCHASE. OTHER THAN THE EXPRESS
WARRANTY, THE PRODUCTS ARE PROVIDED “AS IS” AND ARE DESIGNED FOR USE SOLELY BY QUALIFIED
HEALTHCAREPERSONNELUSINGREASONABLEMEDICALDISCRETIONIN MEDICALLYNECESSARYSITUATIONS.
TELEFLEX DISCLAIMS ALL LIABILITY WITH RESPECT TO THE PRODUCTS ARISING FROM ANY USE OF THE
PRODUCTSTHATISINCONSISTENTWITHTELEFLEX’SPUBLISHEDDIRECTIONSANDINSTRUCTIONSFORUSE.IN
NOEVENTSHALLTELEFLEXBELIABLETOENDUSER,ANYCUSTOMERORANYOTHERTHIRDPARTY(“CLAIMANT”)
INANYMANNERFORANYSPECIAL,NON-COMPENSATORY,CONSEQUENTIAL,INDIRECT,INCIDENTAL,STATUTORY
OR PUNITIVE DAMAGES OF ANY KIND, WHETHER ARISING UNDER CONTRACT OR TORT LAW (INCLUDING
NEGLIGENCEANDSTRICTPRODUCTLIABILITY),REGARDLESSOFTHEFORMOFLEGALACTIONEVENIFTELEFLEX
ISAWAREOFTHEPOSSIBILITYOFANYSUCHDAMAGESINADVANCE.TELEFLEX’STOTALAGGREGATELIABILITY
INCONNECTIONWITHTHEPURCHASEORUSEOFTHEPRODUCTSSHALLNOTEXCEEDTHESUMOFTHEAMOUNTS
PAIDBYCLAIMANTTOTELEFLEXDURINGTHETWELVE(12)MONTHSIMMEDIATELYPRECEDINGTHEDATEOFTHE
EVENTGIVINGRISETOACLAIMAGAINSTTELEFLEX.
Declarations – Electromagnetic Immunity
TheEZ-IO®PowerDriverisintendedforuseintheelectromagneticenvironmentspecied
below.ThecustomerortheuseroftheEZ-IO®PowerDrivershouldassurethatitisissued
insuchanenvironment.
Immunitytest IEC60601testlevel ComplianceLevel ElectromagneticEnvironment-Guidance 
Electrostatic
discharge
(ESD)
IEC61000-4-2
+/-6kVContact
+/-8kVair
+/-6kVContact
+/-8kVair
Floorsshouldbewood,concreteor
ceramictile.Ifoorsarecovered
withsyntheticmaterialtherelative
humidityshouldbeatleast30%.
Electricalfast
Transient/burst
IEC61000-4-4
+/-2kVforpower
supplylines
+/-1kVforinput.
outputlines
Notapplicable
(battery
powered)
Notapplicable
(noI/Olines)
Mainspowerqualityshouldbethat
ofatypicalcommercialorhospital
environment.
Surge
IEC61000-4-5
+/-1kVdifferential
mode
+/-2kVcommonmode
Notapplicable
(battery
powered)
Mainspowerqualityshouldbethat
ofatypicalcommercialorhospital
environment.
Voltage
dips,short
interruptionsand
voltagevariations
onpowersupply
inputlines
IEC
61000-4-11
<5%Ur(>95%dipin
Ur)for0.5cycles
40%Ur(60%dipin
Ur)for5cycles
70%Ur(30%dipin
Ur)for25cycles
<5%Ur(95%dipin
Ur)for5sec
Notapplicable
(battery
powered)
Mainspowerqualityshouldbethat
ofatypicalcommercialorhospital
environment.IftheuseroftheEZ-IO®
PowerDriverrequirescontinued
operationduringpowermains
interruptions,itisrecommendedthat
thepowerdriverbepoweredfrom
anuninterruptiblepowersupplyor
abattery.
Powerfrequency
(50/60Hz)
magneticeld
IEC61000-4-8
3A/m 3A/m
Powerfrequencymagneticelds
shouldbeatlevelscharacteristic
oftypicallocationintypical
commercialorhospitalenviroment.
NOTE:Uristhea.c.mainsvoltagepriortoapplicationofthetestlevel.
Guidance and Manufacturer’s Declaration — Electromagnetic Immunity
TheEZ-IO®PowerDriverisintendedforuseintheelectromagneticenvironment
speciedbelow.ThecustomerortheuseroftheEZ-IO®PowerDrivershouldassure
thatitisusedinsuchanenvironment.
Immunity test IEC 60601
test level
Compliance
Level
Electromagnetic
environment — guidance
ConductedRF
IEC61000-4-6
RadiatedRF
IEC61000-4-3
3Vrms
150kHzto80MHz
3V/m
80MHzto2,5GHz
Notapplicable
(batterypowered)
3V/m
PortableandmobileRF
communicationsequipment
shouldbeusednocloserto
anypartofthedriverincluding
cables,thantherecommended
separationdistancecalculated
fromtheequationapplicable
tothefrequencyofthe
transmitter.Recommended
separationdistance
d = 3,5 P
V1
d = 3,5 P
E1
d = 7 P
E1
wherePisthemaximumoutput
powerratingofthetransmitter
inwatts(W)accordingtothe
transmittermanufacturerandd
istherecommendedseparation
distanceinmeters(m).
FieldstrengthsfromxedRF
transmittersasdetermined
byanelectromagneticsite
survey,ashouldbelessthan
thecompliancelevelineach
frequencyrange.b
Interferencemayoccurinthe
vicinityofequipmentmarked
withthefollowingsymbol:
NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.
NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffected
byabsorptionandreectionfromstructures,objects,andpeople.
aFieldstrengthsfromxedtransmitters,suchasbasestationsforradio(cellular/cordless)
telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcast
cannotbepredictedtheoreticallywithaccuracy.Toassesstheelectromagneticenvironmentdue
toxedRFtransmittersanelectromagneticsitesurveyshouldbeconsidered.Ifthemeasured
eldstrengthinthelocationinwhichtheEZ-IO®PowerDriverisusedexceedstheapplicableRF
compliancelevelabove,theEZ-IO®PowerDrivershouldbeobservedtoverifynormaloperation.If
abnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasre-orientingor
relocatingtheEZ-IO®PowerDriver.bOverthefrequencyrange150kHzto80MHz,eldstrengths
shouldbelessthan3V/m.
Recommended separation distances between portable and mobile
RF communications equipment and the EZ-IO®Power Driver
TheEZ-IO®PowerDriverisintendedforuseinanelectromagneticenvironmentin
whichradiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheEZ-IO®
PowerDrivercanhelppreventelectromagneticinterferencebymaintainingaminimum
distancebetweenportableandmobileRFcommunicationsequipment(transmitters)
andtheEZ-IO®PowerDriverrecommendedbelow,accordingtothemaximumoutput
powerofthecommunicationsequipment.
Ratedmaximum
outputpowerof
transmitter
W
Separationdistanceaccordingtofrequencyoftransmitterm
150kHzto80MHz
d = 3,5 P
V1
80MHzto800MHz
d = 3,5 P
E1
800MHzto2,5GHz
d = 7 P
E1
.01 0.12 0.12 0.23
.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommended
separationdistancedinmeters(m)canbeestimatedusingtheequationapplicabletothe
frequencyofthetransmitter;wherePisthemaximumoutputpowerratingofthetransmitter
inwatts(W)accordingtothetransmittermanufacturer.
NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.
NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationis
affectedbyabsorptionandreectionfromstructures,objects,andpeople.
•MedicalelectricalequipmentneedsspecialprecautionsregardingEMCandneedstobe
installedandputintoserviceaccordinglytotheEMCinformationprovidedinthismanual.
•PortableandmobileRFcommunicationscanaffectmedicalelectricalequipment.
•Theuseofaccessories,transducers,andcablesotherthanthosespeciedbythe
manufacturer,mayresultinincreasedemissionsordecreasedimmunityoftheEZ-IO®
PowerDriver.
•TheEZ-IO®PowerDrivershouldbeobservedtoverifynormaloperationinthe
congurationitwillbeused.
•TheEZ-IO®PowerDriverisdesignedandtestedtorunintermittentlywithadutycycleof
30secondson,1minuteofffor5consecutivecycles.Allow1hourcooldowntime.
Equipment Classification
Typeofprotectionagainstelectricshock NAinternalpoweredequipment
Degreeofprotectionagainstelectricshock TypeBFappliedpart
Degreeofprotectionagainstingressofwater IPXOOrdinaryprotection
Degreeofsafetyorapplicationinthepresenceof
aammableanestheticmixture
Equipmentnotsuitableforuseinthepresence
ofaammableanestheticmixturewithairor
withoxygenornitrousoxide
Declaration-Electromagnetic Emissions
TheEZ-IO®PowerDriverisintendedforuseintheelectromagneticenvironment
speciedbelow.ThecustomerortheuseroftheEZ-IO®PowerDrivershouldassure
thatitisissuedinsuchanenvironment.
Emission Test Compliance Compliance
RFEmissionsCISPR11 Group 1
TheEZ-IO®PowerDriverusesRFenergyonlyfor
itsinternalfunction.Therefore,itsRFemissions
areverylowandarenotlikelytocause
interferenceinnearbyelectronicequipment.
RFEmissionsCISPR11 Class B TheEZ-IO®PowerDriverissuitableforuse
inallestablishments,includingdomestic
establishmentsandthosedirectlyconnected
tothepubliclowvoltagepowersupply
networkthatsuppliesbuildingsusedfor
domesticpurposes.
HarmonicemissionsIEC
61000-3-2
Not
applicable
Voltageuctuations/icker
emissionsIEC61000-3-3
Not
applicable
Warranty InformatIon
INTRAOSSEOUS VASCULAR ACCESS
EZ-IO