EZ-IO® POWER DRIVER
2
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); 9059 (Training). • 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 Teleflex sales representative. • Additional product information can be found at EZ-IOaccess.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, modifications, technical maintenance or repairs are not allowed. • Do not connect this product or its components to products not recommended by Teleflex. • Use only EZ-IO® Intraosseous Vascular Access needle sets with this product. • Visually inspect driver for cracks and sharp corners before use. • Avoid spilling fluids 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 sufficient 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 specific 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, NX® System, and 100NX® System. STERRAD® Systems are products of ©ADVANCED STERILIZATION PRODUCTS, Division of Ethicon Inc., a Johnson & Johnson company. WARNING: No modification of this equipment is allowed. PRODUCT INFORMATION FOLD FOLD FOLD FOLD FOLD FOLD PRODUCT INFORMATION EZIOaccess.com EMERGENCY NUMBER: 1.800.680.4911 Customer Service: 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. EC REP European Authorized Representative Service Degree of protection against electric shock BF Applied part. Consult Instructions For Use C 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) EMERGO EUROPE Molenstrat 15 2513 BH, The Hague Netherlands AUSTRALIAN SPONSOR Emergo Australia Level 20, Tower II Darling Park 201 Sussex Street Sydney NSW 2000 Australia VIDACARE LLC 4350 Lockhill Selma Road, Suite 150 Shavano Park, TX 78249 United States This device is restricted for sale by or on order of a physician. 8047 Rev D (07/2014) INTRAOSSEOUS VASCULAR ACCESS EZ-IO INTRAOSSEOUS VASCULAR ACCESS EZ-IO Instructions for Use EZ-IO ® POWER DRIVER
Transcript of EZ-IO® POWER DRIVER
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
FOLD FOLD FOLD
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INTRAOSSEOUS VASCULAR ACCESS
EZ-IO
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