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Users Manual | Users Manual | 3.63 MiB | September 10 2015 | |||
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1 | Users Manual | Users Manual | 3.63 MiB | September 10 2015 |
UVLrxStationModelUVL1500UserManual ModelUVL1500: ManufacturedintheU.S.A.,forExportOnly. Caution:
Manufacturer:
Federallawrestrictsthisdevicetosalebyorontheorderofaphysicianorproperly licensedhealthcareprovider. UVLrxTherapeuticsInc. 640BrookerCreekBlvd.,Suite455,Oldsmar,FL34677 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page1of55 TABLEOFCONTENTS 4. 3. 1. 3.3. 3.2. INTRODUCTION..............................................................................................................................4 1.1. INDICATIONFORUSE.......................................................................................................................4 CONTRAINDICATIONS......................................................................................................................4 1.2. 1.3. ACKNOWLEDGEMENTSANDACCREDITATIONS......................................................................................5 2. WARNINGSANDCAUTIONS...........................................................................................................6 2.1. RESTRICTIONSONUSE.....................................................................................................................6 2.2. WARNINGS...................................................................................................................................6 2.3. CAUTIONS.....................................................................................................................................7 SYSTEMCOMPONENTS..................................................................................................................9 UVLRXSTATIONDESCRIPTION.....................................................................................................10 3.1. 3.1.1. UVLrxStationCleaningInstruction...................................................................12 PATIENTCABLEDESCRIPTION..........................................................................................................13 3.2.1. PatientCableCleaningInstruction.......................................................................15 DRYLIGHTADAPTER(DLA).........................................................................................................16 3.3.1. DryLightAdapterCleaningInstruction.............................................................17 LABELS&SYMBOLS......................................................................................................................18 SYMBOLS....................................................................................................................................18 4.1. 4.2. DEVICELABEL..............................................................................................................................20 FRONTBEZELLABEL......................................................................................................................20 4.3. UVLRXSECURITY.......................................................................................................................21 4.4. 4.5. SHIPPINGCASELABEL....................................................................................................................22 4.6. RFIDTARGETLABEL.....................................................................................................................22 UNPACKING&INSTALLATION......................................................................................................23 UNPACKTHEUVLRXSTATION......................................................................................................23 5.1. 5.1. SURFACEMOUNTORIVPOLEMOUNTING?......................................................................................24 5.1.1. IVPoleMountingConfiguration.............................................................................24 CONNECTPOWERTOTHEUVLRXSTATION.....................................................................................26 5.2. POWERONTHEUVLRXSTATION.................................................................................................27 5.3. CONNECTTHEPATIENTCABLE.........................................................................................................28 5.4. 5.5. HOLSTERTHEPATIENTCABLE.........................................................................................................29 CONNECTIONOFDRYLIGHTADAPTER.......................................................................................30 CONNECTIONOFDRYLIGHTADAPTERTOCATHETER........................................................................30 6.1. 6.2. CONNECTIONOFDRYLIGHTADAPTERTOPATIENTCABLE..................................................................31 OPERATINGINSTRUCTIONSANDUSERINTERFACE.......................................................................32 BEGINNINGATREATMENT:CALIBRATION..........................................................................................32 7.1. 7.1.1. HomeScreen...........................................................................................................32 7. 5. 6. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page2of55 9. 7.2. 7.1.2. MainScreen............................................................................................................33 PatientCableUVLrxSecurityScanningScreen..................................................34 7.1.3. DryLightAdapterUVLrxSecurityScanningScreen...........................................35 7.1.4. PreCalibrationScreen............................................................................................36 7.1.5. 7.1.6. CalibrationScreen...................................................................................................37 7.1.7. CalibrationSuccessfulScreen..................................................................................38 STARTINGTREATMENT..................................................................................................................39 PreTreatmentScreen.............................................................................................39 7.2.1. 7.2.2. InTreatmentScreen...............................................................................................40 TreatmentPausedScreen.......................................................................................41 7.2.3. 7.2.4. TreatmentCompleteScreen...................................................................................42 8. MAINTENANCE............................................................................................................................43 UVLRXSTATION........................................................................................................................43 8.1. PATIENTCABLE............................................................................................................................43 8.2. DRYLIGHTADAPTER..................................................................................................................43 8.3. FUSES.........................................................................................................................................43 8.4. 8.5. DISPOSAL/ENVIRONMENTALDIRECTIVES.........................................................................................43 TROUBLESHOOTING.....................................................................................................................44 CALIBRATIONINCOMPLETE.............................................................................................................44 9.1. UVLRXSECURITYSCANNINGNONRESPONSIVE...............................................................................45 9.2. 9.3. TOUCHSCREENNONRESPONSIVE....................................................................................................45 9.4. LOSSOFPOWER...........................................................................................................................45 9.5. MISCELLANEOUSERRORS...............................................................................................................45 PROTECTIVEEYEWEAR.................................................................................................................46 SERVICE.......................................................................................................................................47 LIMITEDWARRANTY....................................................................................................................48 POINTOFCONTACT......................................................................................................................49 TECHNICALSPECIFICATIONS.........................................................................................................50 14.1. MODELUVL1500SYSTEMSPECIFICATIONS......................................................................................50 14.2. MODELUVL1500PERFORMANCESPECIFICATIONS............................................................................50 14.3. POWERCORDREQUIREMENTS........................................................................................................51 ACCESSORYTECHNICALSPECIFICATIONS:MODELUVL1510PATIENTCABLE..........................................51 14.4. 14.5. ACCESSORYTECHNICALSPECIFICATIONS:MODELUVL1520DRYLIGHTADAPTER...................................51 14.6. LISTOFACCESSORIES.....................................................................................................................51 PRODUCTENVIRONMENTALREQUIREMENTS...............................................................................52 15.1. MODELUVL1500&ACCESSORIESENVIRONMENTALTECHNICALSPECIFICATIONS:STORAGE.....................52 15.2. MODELUVL1500&ACCESSORIESENVIRONMENTALTECHNICALSPECIFICATIONS:OPERATION..................52 15.3. MODELUVL1500ELECTROMAGNETICREQUIREMENTS.......................................................................52 10. 11. 12. 13. 14. 15. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page3of55 1. INTRODUCTION TheUVLrxStation,ModelUVL1500,isdesignedtoemitacombinationofUVA+REDlightfor30 minutes,followedbyanautomatictransitiontoacombinationofRED+GREENlightfor30minutes. Totaltreatmenttimelasts60minutes.Thethreekeywavelengthsare:
UVA:
RED:
365nmreductionofpathogens 630nmimmunesystemmodulation,inflammationreduction,andATP synthesisupregulation GREEN: 530nmimprovebloodoxygentransportandfavorablehemodynamics Each wavelength strategically targets key biochemical pathways within the body, which, when combined,generateanobservablereductioninpatientpain. TheUVLrxStationisdesignedtogiveauthorizedusersauniqueabilitytoharnessanddeliverthe therapeuticpoweroflight.Authorizeduserswillnotberequiredtomakeanyadjustmentstothe devicesoutputparameters.UVLrxStationisdesignedtoworkonlywithUVLrxTherapeuticsPatient CableandDryLightAdapter(DLA),throughsecureradiofrequencyidentificationtechnology(RFID). TheopticalemissionfromUVLrxStationisdeliveredthroughthePatientCable,throughtheDLA,and intoanexisting20gax1catheter,illuminatingthepassingbloodsupplyinthevein.Nopartofthe DLAextendsbeyondthecatheterlumenorintothebody. 1.1. INDICATIONFORUSE The UVL1500 and accessories are intended for Intravenous Light Therapy for immune system modulation, reduction of inflammation, reduction of pathogens in the blood stream, improved adenosine triphosphate (ATP) synthesis, reduction of pain, improved circulation and blood oxygen transport,andimprovedwoundhealing. 1.2. CONTRAINDICATIONS Patientslessthan18yearsold Pregnancyandbreastfeeding Diagnosedwithorhavebeentreatedforclottingdisorders(e.g.thrombophlebitis,factorV Leiden) Knownbloodclotlocatedproximaltotheproposedcathetersite Axillarylymphnodedissectionwithlymphedemaalongextremityofproposedcathetersite Activecellulitisalongproposedcathetersite ProposedcathetersitedistaltoAVfistula SubjectishypersensitiveorallergictotapeorTegadermoranycomponentsincontainedin suchadhesiveproducts 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page4of55 1.3. ACKNOWLEDGEMENTSANDACCREDITATIONS TheUVLrxStationisdesignedtobeinaccordancewith:
ManufacturedUnder:
o FDAGoodManufacturingPractices o ISO13485MedicalDeviceQuality IEC62471LightEmittingDiodeSafety IEC6060112EMC IEC6060111Safety 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page5of55 2. WARNINGSANDCAUTIONS ReviewthisUserManualcompletely,priortouse.WarningsandCautionsrefertoconditionswhich eithermaypossiblycauseinjurytothepatientoruser,ormaypossiblycauseequipmentdamageor malfunction,respectively. 2.1. RESTRICTIONSONUSE U.S.FederalLawrestrictsthisdevicetobesoldbyaphysicianorbytheorderofaphysician. Thislightbaseddeviceisintendedonlyforphysicianstrainedintheuseofthesethisdevice. 2.2. WARNINGS Donotuseequipmentif,uponreceipt,packageisopened,damaged,orshowsanysignsof tampering. Donotuseequipmentinthepresenceofflammableanesthetics,gases,disinfectingagents, cleaningsolutions,oranymaterialsusceptibletoignitionduetoelectricalsparking. Toavoidtheriskofelectricshock,thisequipmentmustbeconnectedtoasupplymainswith protectiveearth.Thevoltageandfrequencycharacteristicsmustbecompatiblewiththose listedontheunitorinthismanual.Donotuseplugadaptersorextensioncords;suchdevices maydefeatthesafetygroundandcouldresultininjury. Donotusesterileequipmentbeyondtheexpirationdatelistedonthelabel.Sterilityofthe UVL1520 cannot be assured beyond the expiration date. UVLrx Station and Patient Cable suppliednonsterile.DonotattempttosterilizeUVLrxStationorPatientCable. Donotexcessivelybend,kinkorcrushthePatientCable.AlwaysinspectthePatientCablefor signsofexcessivewearordamage.Ifwearordamageisfound,discontinueuseandreplace immediately.Failuretodosomaycompromiseoutputwavelengthcalibratedirradiance. PatientCablesareprovidednonsterile.Cleanonlyasprovidedinthisusermanual.Donot attempttosterilizethePatientCable. Donotexcessivelybendorkinkthepowercord.Alwaysinspectcordsforsignsofexcessive wearordamage.Ifwearordamageisfound,discontinueuseandreplaceimmediately.Using adamagedpowercordcouldpossiblycauseinjury. Donotstoreliquidsonorneartothedevice,orinsuchanorientationasmightpossiblylead toaspillontoorintothedevice. DonotimmerseanypartoftheUVLrxStationinfluidsforanyreason.Immersionmayrender thedeviceinoperable. Thissystemmaycauseradiointerferenceormaydisrupttheoperationofnearbyequipment. Avoidstackingequipment.Itmaybenecessarytotakemitigationmeasures,suchasorre orienting or relocating the UVL1500 or shielding the location. See section 14.1 and 15 for additionalinformationregardingradiointerferenceandEMCdata. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page6of55 ThePatientCable,andbyextensiontheDryLightAdaptor,istheappliedpart.Avoidcontact withothernon"BF"ratedpoweredinstrumentswhileincontactwiththepatient,asthismay createacurrentleakagepathtoearth. Donotconnectknowndamagedequipmentorequipmentthatiscorrodedorwet.Failureto complymaycauseinjuryorresultindamagetoequipment. AllDryLightAdaptorsaresingleuseonly.DoNotResterilize.Theabilitytoeffectivelyclean andresterilizethissingleusedevicehasnotbeenestablishedandsubsequentreusemay adverselyaffecttheperformance,safetyand/orsterilityofthedevice.Afteruse,disposeof properly. Donotlookdirectlyintotheemissionport,patientcable,orDLAaperture(s)whileoperating. Ifusinginconjunctionwithconcomitant(drug)therapy,consultwiththedrugmanufacturers safetyinformationregardingphotosensitizationeffects. DonotpositiontheUVLrxStationinanorientationthatmakesdisconnectingthemedical gradepowercordfromthedevicedifficult. The means to isolate all poles of UVLrx Station from supply mains is removal of the detachablepowercordfromtheapplianceinlet.Seesection14.3ofthismanualforpower cordrequirements. TheUVL1500shouldbeprotectedagainstunauthorizeduse. Changes or modifications not expressly approved by the party responsible for compliance couldvoidtheusersauthoritytooperatetheequipment. 2.3. CAUTIONS Handleallequipmentcarefully.Ifanyequipmentisdroppedordamagedinanyway,returnit immediatelyforservice. Donotusethisequipmentifyoususpectitoffunctioningimproperlyorotherthandescribed herein. UseonlyassociatedUVLrxTherapeuticsapprovedequipmentandaccessories.Theyhave beentestedandcertifiedtospecificmedicalstandards.Usingunapprovedaccessoriesmay resultinimproperoperation,maynegativelyaffectEMCperformanceandmayresultinnon compliancetomedicalstandards.Observesection15.3forEMCinformation. Thewarrantybecomesvoidandthemanufacturerisnotliablefordirectorresultingdamage if:
1. Thedeviceortheaccessoriesareimproperlyused,preparedormaintained;
2. Theinstructionsinthemanualarenotadheredto;
3. Nonauthorized persons perform repairs, adjustments or alterations to the device or accessories. There are no userserviceable parts inside, except for the fuses. No modification of this equipment is allowed. Removing the cover may introduce an electrical shock hazard by 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page7of55 exposingyoutodangerouslyhighvoltagesorotherrisksordisrupttheintegrityofthedelivery oflight. Donotattempttoservicethedeviceyourself(otherthanfuses).AlwayscontactyourUVLrx Therapeuticsauthorizeddistributorforservice. Ifthisequipmentismodified,appropriateinspectionandtestingmustbeconductedtoensure continuedsafeuseofequipment. Service intervals, as listed in section 11 Service, are required to keep the equipment operatingatoptimumperformance. ProvideadequateventilationforUVLrxStationbyplacingthedevicesuchthatthesidesand back are no closer than 2 from an opposing surface (e.g. wall) to optimize cooling performance. DonotscratchtheopticalfacesofthePatientCable.Damagemayresult. Do not use any instrumentation, especially sharp objects, to make selections on the touchscreendisplay.Damagemayresult. Replace the dust cap on the Calibration Port between uses to ensure consistent optical calibrations. DonotshipthedeviceexceptaspackagedinthecustomshippingcaseprovidedwiththeUVLrx Station.Usingunapprovedpackagingmayresultinimproperoperation,ordamagetothe equipment. EnsuretrainingisprovidedtoyouonlybyUVLrxTherapeuticsauthorizedrepresentative(s). TheUVLrxStationshouldonlybeusedbyhealthcareproviderswhohavereceivedtrainingin itsuse. TheUVLrxStationintegrateswithstandard20gax1catheters.UVLrxTherapeuticsdoes not endorse or train on techniques concerning PIV catheterization and normal saline drip. PleaseensurepropertechniqueisimplementedandPIVintegritywillbemaintainedbefore incorporatingtheUVLrxStation. Consultpatientmedicalhistoryforsensitivitytoultravioletlight. TheUVLrxStationshouldbeutilizedinaclearlymarkedtreatmentarea. TurntheUVLrxStationoffbeforeleavingunattended. Useofcontrolsoradjustmentsorperformanceofproceduresotherthanthosespecifiedherein maybehazardous. Cleanalltheequipmentandassociatedaccessoriesaccordingtotheinstructionsoruse. CleanbothendsofPatientCable,specificallytheopticalfaces,withanisopropylalcoholwipe
(minimum70%IPA),priortofirstuse. Clean Patient Cable with an isopropyl alcohol wipe (minimum 70% IPA), between uses, howeverleavePatientCableendconnectedtoUVLrxStationemissionportunlesschanging PatientCables. IVpolemountingrequiresuseofincludedPoleClamp,allowingupto1diameterIVpoles. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page8of55 3. SYSTEMCOMPONENTS
. TheModelUVL1500UVLrxStationissuppliedwith:
(1) ModelUVL1500UserManual
(2) Two(2)PatientCables
(3) PowerCord
(4) IVPoleClamp
(5) CustomHardSidedShippingCase 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page9of55 3.1. UVLRXSTATIONDESCRIPTION 1. Handle 2. PatientCableHolder 3. TouchScreenDisplay 4. CalibrationPort 5. BlueRingLitStandBy Switch 6. EmissionPort Allowusertomovethedevice Holdsfiberopticcablewhennotinuse ProvidesgraphicaluserinterfaceDisplayON indicatesdeviceisON. ThedistalendofthePatientCable(withtheDLA adapterandSlipLockRing)connectstothisportfor calibrationpriortoeachtreatment.EnsureIntegrated dustcapinplacebetweencalibrations. Providesuserwithmeanstoplacedeviceintoandout ofstandbymode.OnepressturnsthedeviceON. Pressandholdthebuttonfortwosecondstoreturnto standbymode.Markedwithstandbysymbol. Opticalenergyemittedfromthisport.PatientCable normallyconnectedtothisport.TypeBFAppliedPart. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page10of55 1. PatientCableHolder 2. InputFanVent HolsterthePatientCablewhennotinuse Ventdisplacescoolairinternallytomaintaininternal temperatures.Leaveatleast2betweenthissideand anopposingsurface(e.g.wall) 3. IVPoleMountingBracket BracketdesignedforconnectiontoUVLrxTherapeutics suppliedPoleClamp 1. ExhaustFanVent 2. PowerEntryModule 3. DeviceLabel Ventsairfromwithindevice.Leaveatleast2between thissideandanopposingsurface(e.g.wall) ConnecttoACmainswithIECcompatiblepowercord. Suppliesdevicespecificinformation. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page11of55 1. RFIDRingLitIndicator PoleClamp:
AringofLEDs,surroundinganantennasymbol,flash whentheuserispromptedtoscaneitherthePatient CableorDryLightAdapterRFIDsecuritytag. 1. 2. 3. IVPoleslot IVPoleTensioner IVPoleMountingBracket Slots AttachpoleclamptoIVPolehere TightentheIVPoleTensionertoensurePoleClampis fastenedsecurelytoIVPole Bracketdesignedtoslidedownintoslots 3.1.1. UVLrxStationCleaningInstruction TheUVLrxStationsurfacesmaybecleanedwithanisopropylalcoholwipe(minimum70%IPA),or lightlydampenedclothwithamilddetergent.Donotallowfluidsintothefanventholes,orintothe PowerEntryModule.EnsuretheUVLrxStationisunpluggedpriortocleaning. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page12of55 3.2. PATIENTCABLEDESCRIPTION TheUVLrxStationissuppliedwithtwo(2)PatientCables.EachPatientCableisfivefeetlong,andis designedfor6monthsofuse.DisposeofPatientCableafter6monthspersection8ofthismanual. PatientCablesaredesignedforextended,reusableuseandareprovidednonsterile.ThePatient CableisidentifiedbythePatientCableRFIDLabel,centeredonthepatientcable,whichalsocontains anRFIDidentificationdevice(seeSection7oftheUserManualfordescriptionofUVLrxSecurity usage). EachPatientCablearrivescoiledwithin aclear,sealedbag(seeimageatright). 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page13of55 EachPatientCableisdesignedforextended,reusableuse,andcanbecleanedwithanisopropylalcohol wipe(minimum70%IPA).ThePatientCablecontainstwoendswhicheachserveaspecificpurpose:
EmissionPortSide:Connecttoemissionporton UVLrxStation CalibrationPort/DLASide:Connecttoeither CalibrationPortonUVLrxStationortoDry LightAdapter(DLA) Note:DisposaloftheUVL1510PatientCableisrequiredaftersixmonthsofuse.SeeSection8.5 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page14of55 3.2.1. PatientCableCleaningInstruction Uponinitialuse,theEmissionPortSidewillcontainablacksiliconerubbersleeve.Wearingclean,non latexgloves,removethissleeveandgentlywipedownthemetalstemandopticalfacetherewithan isopropylalcoholwipe(minimum70%IPA).Thiswillensurenooilordebrisremainsontheoptical face.Oncecleaned,carefullyinsertthisendintotheEmissionPortontheUVLrxStation.Screwthe terminal down firmly. This end should not be removed during routine use, except to replace the PatientCable.TwoPatientCablesaresuppliedwiththeUVLrxStationforaprojected12monthsof use.ThePatientCableisanaccessorywhichcanbepurchasedfromUVLrxTherapeuticsInc.Only UVLrxTherapeuticssuppliedPatientCablesmaybeusedwiththeUVLrxStation.UVLrxStation calibratespriortoeachtreatment,andcalibrationaccuracyandconsistencyaredependentuponuse ofUVLrxTherapeuticssuppliedPatientCables. CleaningoftheCalibrationPort/DLAsideofthePatientCablemaybeaccomplishedasfollows:
(1) Remove the stainless steel tapered adapterfromtheendofthePatient Cable.
(2) Gently wipe down the metal stem and optical face of the fiber optic cablewithanisopropylalcoholwipe
(minimum70%IPA).
(3) Gently wipe down the faces of the taperedadapterandsliplockring. Note:Thetaperedadapterandthis end of the Patient Cable may be submerged isopropyl alcohol or hydrogen peroxide as necessary. in either
(4) Allowallsurfacestoairdry.
(5) Reassemble the tapered adapter onto the Patient Cable and screw downtightly. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page15of55 3.3. DRYLIGHTADAPTER(DLA) TheDryLightAdapter(DLA)isasinglepatient,singleusedisposablecomponent.TheDLAissupplied sterileinaTyvekpouch.UseofthePatientCableandDLA,assuppliedbyUVLrxTherapeutics,is essentialtoachievingthespecifiedopticalperformanceoftheUVLrxStation. 1. PatientCableOpticalInterface 2. LuerConnectiontoSalineDrip 3. SlideClamp 4. SalineEntryPort 5. TaperedNozzle 6. OpticalGuide Thisendslidesintothetaperedadapterofthe PatientCable,andissecuredtherewithaturn ofthePatientCablessliplockring. Connectionforstandardsalinedrip. TheSlideClamppreventsingressoffluidsafter theDLAisprimedwithsaline. Salinefromthesalinedripentersthebodyofthe DLAhere,flowsintoDLA,andoutalongsideof theopticalguideandintothepatient. Providessecure,leakfreepressfitconnectionto standard20gax1catheter. Thiscomponentdeliversopticalenergyreceived fromthePatientCabledownintotheexisting catheter.TheOpticalGuideiscontainedwithina hypodermicstainlesssteelguide,anddoesnot extendbeyondthecatheterlumen,norintothe patientsbody. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page16of55 3.3.1. DryLightAdapterCleaningInstruction TheDryLightAdapter(DLA)issuppliedsterileinaTyvekpouch.RemovetheDLAfromits packagingonlyafterapplicationofsterilegloves,toensurenooilsorfluidsaretransmittedto eitheroftheopticalfacesoftheDLA. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page17of55 4. LABELS&SYMBOLS 4.1. SYMBOLS Caution TypeBFAppliedPart RatedSupplyVoltage 100240V,50/60Hz Fuse ConsultInstructionsfor Use DisposalIndication/
WEEESymbol Locationof Manufacture SterileUsing Irradiation ModelNumber SerialNumber TemperatureLimitation ECRepresentative HumidityLimitation AtmosphericPressure Limitation KeepAwayfromRain NonSterile CEMarkSymbol ElectricalSafetyand IECTestingSymbols SoldOnlyto HealthcareProviders DoNotUseifPackage isDamaged 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page18of55
(symbolscontinued) UVEmissionSource StandBySwitch VisionWarning DoNotReuse Fragile,Handlewith Care NonIonizingRadiation
(RFID) LMarkSymbol Calibration DoNotResterilize UseBy ProtectiveEarth Ground 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page19of55 4.2. DEVICELABEL Thesystemrequirestwo(2)fuses,eachratedat2ALand250VwithtimelagT. 4.3. FRONTBEZELLABEL TheUVLrxStationemitsUVAlightfromtheEmissionPort.Theuseriscautionednottolookdirectlyintothe EmissionPortwhentheUVLrxStationisemittinglight(eitherduringacalibrationorduringtreatment).The PatientCableshouldalwaysbeconnectedtotheEmissionPortwhentheUVLrxStationisusedaccordingtothe UserManual.TheemissionportisaTypeBFAppliedPart. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page20of55 4.4. UVLRXSECURITY TheUVLrxStation,ModelUVL1500,utilizessecureradiofrequencyidentification(RFID)technologytoensure onlyUVLrxTherapeuticscertifiedPatientCablesandDryLightAdaptersareusedfortreatment.Theoptical emissionoutputirradianceisdependentonthespecificdesignofthePatientCablesandDryLightAdapters.The UVLrxSecuritylabelisappliedtotheDryLightAdapterTyvekpouch(seeaboveleft).ThePatientCablecontains aUVLrxSecuritytaglocatedmidcable(seeaboveright).Whenprompted,theuserisrequiredtoplacethistag withintheilluminatedringonthesideoftheUVLrxStationtobescanned. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page21of55 4.5. SHIPPINGCASELABEL TheUVLrxStation(andaccessoriesincludingModelUVL1500UserManual,Two(2)PatientCables,PowerCord, andIVPoleClamp)isshippedwithinacustomhardsidedshippingcase.Thehealthcareproviderisrequiredto storethehardsidedshippingcaseforfuturetransportationoftheUVLrxStation,toensurethedeviceisproperly securedandcushioned.Theshippingcaselabelisaffixedtothecenterofthelidoftheshippingcase. 4.6. RFIDTARGETLABEL AffixedovertheregiononthesideoftheUVLrxStationwheretheRFIDisusedforaccessoryrecognition. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page22of55 5. UNPACKING&INSTALLATION Thediagramshowstheconnectionbetweenthepowersupplycable,UVLrxStation,PatientCable,DryLight Adapter,andexisting20gax1catheter. Power UVLrxStation PatientCable DryLightAdapter 20gax1"Catheter 5.1. UNPACKTHEUVLRXSTATION The UVLrx Station is shipped from the manufacturer in a custom hardsided shipping case. Open the shippingcaseandinspecttoensurethefollowingarecontainedwithin:
(1) UVLrxStation
(2) ModelUVL1500UserManual
(3) Two(2)PatientCables
(4) PowerCord
(5) IVPoleClamp Removetheusermanual,patientcables,powercord,andpoleclamp.Settheshippingcaseasideandretain itforfuturetransportationorservice.Ifanycomponentismissing,pleasecontactcustomerservice. PlacetheUVLrxStationonastabilesurfaceorutilizetheIVPolemountingmethod. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page23of55 5.1. SURFACEMOUNTORIVPOLEMOUNTING?
TheUVLrxStationisdesignedtobeplacedonastabilesurfaceormountedtoanIVPole(upto1diameter). PriortosettinguptheUVLrxStation,decideonaninitialplacementconfiguration. IVPoleMountingConfiguration 5.1.1. TheUVLrxStationcanbemountedtoanexistingIVPoleinthreesteps:
(1) IdentifythePoleClampsuppliedwiththeUVLrxStation 1. 2. 3. IVPoleslot IVPoleTensioner IV Pole Mounting Bracket Slots AttachpoleclamptoIVPolehere TightentheIVPoleTensionertoensurePoleClampis fastenedsecurelytoIVPole Bracketdesignedtoslidedownintoslots
(2)ConnectthePoleClamptoan existingIVPole 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page24of55
(3) SlidetheUVLrxStationsIVPoleMountingBracketintotheslotsofthePoleClamp,seatingitfully. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page25of55 5.2. CONNECTPOWERTOTHEUVLRXSTATION Connectthe IECC13end ofthe powercord tothe applianceinletasindicatedintheimageabove. ConnecttheotherendofthepowercordtoACmainswithprotectiveearthgrounding. Afterseveralseconds,theblueringlitStandBySwitchwillbegintoilluminate,breathingbluelight. ThisindicatesthattheUVLrxStationisinstandbymode. Forinternationaluse,apowercordappropriatetotheregionmustbemedicalgrade,18awgwire,3 conductor,andhaveanIECC13stylereceptacle.ThepowercordsuppliedbyUVLrxTherapeutics containsaNEMA515Ptypeplug. TheUVLrxStationisdesignedtoaccept100240V,50/60Hz. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page26of55 5.3. POWERONTHEUVLRXSTATION PresstheSTANDBYSWITCHonce.EnsurethatthetouchscreendisplaypowersON,showingthehomescreen. Aslightfannoisewillbeheard.Uponexitingstandbymode,thedevicewillsoundasinglebeep. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page27of55 5.4. CONNECTTHEPATIENTCABLE BeforeconnectingthePatientCabletotheUVLrxStation,pleasefollowthecleaninginstructionsprovided insection3.2.1.TheendsofthePatientCablearehighlypolished,andthisprocedurewillensureoptimum opticalperformance. Connect the end of the Patient Cable shown at right to the Emission Port of the UVLrx Station shownbelow:
2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page28of55 5.5. HOLSTERTHEPATIENTCABLE SecuretheoppositeendofthePatientCableintheCableMount,indicatedbelow:
2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page29of55 6. CONNECTIONOFDRYLIGHTADAPTER TheDryLightAdapter(DLA)isasinglepatient,singleusedisposablecomponent,soldseparatelyfromtheUVLrx Station.Clinicaltreatmentrequirestheuseofanexistingappliedstandard20gax1catheter.Bydesign,the 20gax1catheteristheoptimalcatheterinnerdiameterandlengthtoensureoptimalopticalperformance.Use ofsmallergaugecatheterswillnotallowsalinetoflownormally.Useoflongercatheter(lumen)lengthwillnot ensure optimal optical performance. Only DLAs and Patient Cables supplied by UVLrx Therapeutics Inc. will guaranteetheUVLrxStationdeliversthespecifiedopticalirradiancevalues,andcorrespondinglythedesired opticaldosages. 6.1. CONNECTIONOFDRYLIGHTADAPTERTOCATHETER Seesection3.3forthefiguredescribingthevariouscomponentsoftheDLA.Thetaperednozzleisdesignfor apressfitintostandardcatheters.Thepressfitprovidesasecure,leakfreeconnectiontothecatheter. Theendoftheopticalguide,whenusedwitha20gax1catheter,willnotexceedthelengthofthecatheter lumen.Theendoftheopticalguideisflat,andisnotaneedle.Seebelowforpressfitconnection:
ProperlyseatedcatheteronDLAtaperednozzle:(itisgoodpracticetowipebothopticalendsoftheDLAprior toconnectiontocatheterandPatientCable) 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page30of55 6.2. CONNECTIONOFDRYLIGHTADAPTERTOPATIENTCABLE See section 3.3 for the figure describing the various components of the DLA. The Patient Cable Optical InterfaceendoftheDLAisdesignedtobeinsertedintothetaperedadapterendofthePatientCable.The taperedadapterendofthePatientCablealsocontainsasliplockringwhichthreadsoverthewingsofthe DLA,providingasecurefit.ThedesignoftheDLAdoesnotallowfluidstoflowbackthroughthePatientCable OpticalInterface. CarefullyinsertthePatientCableOpticalInterfaceendoftheDLAintothetaperedadapterendofthePatient Cable.Followinginsertion,twistthesliplockringatleastturntoensuretheDLAisfullyseated.Verifythe sliplockringwillnolongerspinontoDLAwhenfullyseated. IncorrectPlacement:SlipLockRingnotfullyengagedwithDLA:
CorrectPlacement:SlipLongRingfullyengaged:
2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page31of55 7. OPERATINGINSTRUCTIONSANDUSERINTERFACE OncetheUVLrxStationhasbeeninstalled,thePatientCableconnectedtotheEmissionPortand holstered in the Cable Mount, and the device turned ON, the device may be operated as follows. Powering 7.1. BEGINNINGATREATMENT:CALIBRATION TheUVLrxStationincorporatesasimpletouchscreenuserinterfacetoguidetreatmentsetup. 7.1.1. HomeScreen Thehomescreen,shownbelow,containsonetouchscreenbutton,ENTER.PressingENTERwillguide youtothenextstepofthedevicecalibration.Thedevicecalibratesallwavelengthsfortargetirradiance outputpriortoeverypatienttreatment. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page32of55 Atthebottomleftofallscreensisascreenrevision,inthiscase660001C.Atthebottomrightof all screens is the software revision. These are useful when the healthcare provider has a service problem.Theservicetechnician,duringaservicecall,willaskthehealthcareproviderwhichscreen revisiontheyarelookingat. Note:Allscreentransitionsareaccompaniedbyasingleaudiblebeep. MainScreen 7.1.2. TheMainScreenofferstwooptions,CALIBRATEandCANCEL.TheCANCELfunctionwill,fromanyscreen, returntheusertotheHomeScreen.Toproceedwithcalibration,pressCALIBRATE. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page33of55 PatientCableUVLrxSecurityScanningScreen 7.1.3. The Patient Cables UVLrx Security tag is located approximately 2.5 feet from the Emission Port end of the Patient Cable. Upon pressing CALIBRATE from the Main Screen, the UVLrx Station will display the Patient Cable Scanning Screen. Upon pressing START, a ring of twelve lights will illuminate one side of the UVLrx Station, flashing once per second. The START button will invert and change to WORKING. The user must place the UVLrx Security tag against the side of the UVLrx Station, within the flashing ring of LEDs. Once the UVLrx Station recognizes the UVLrx Security tag, an audible beep will be heard and the LEDs will flash rapidly for three seconds. The screen will automatically transition to the Dry Light Adapter - Scanning Screen. The user may press CANCEL at any time to return to the Home Screen. If the user fails to place the UVLrx Security tag against the side of the UVLrx Station, within the flashing ring of LEDs, inside of twenty seconds, the inverted indicator will change back to the START button, and the ring of LEDs will turn off. The user may press START to reattempt to scan the Patient Cable UVLrx Security tag, or press CANCEL to return to the Home Screen. WORKING 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page34of55 DryLightAdapterUVLrxSecurityScanningScreen 7.1.4. The Dry Light Adapters UVLrx Security tag is located on the front of the Tyvek pouch of the Dry Light Adapter. After successful scan of the Patient Cable UVLrx Security tag, the UVLrx Station will display the Dry Light Adapter Scanning Screen. Upon pressing START, a ring of twelve lights will illuminate one side of the UVLrx Station, flashing once per second. The START button will invert and change to WORKING. The user must place the UVLrx Security tag against the side of the UVLrx Station, within the flashing ring of LEDs. Once the UVLrx Station recognizes the UVLrx Security tag, an audible beep will be heard and the LEDs will flash rapidly for three seconds. The screen will automatically transition to the Pre-Calibration Screen. The user may press CANCEL at any time to return to the Home Screen. If the user fails to place the UVLrx Security tag against the side of the UVLrx Station, within the flashing ring of LEDs, inside of twenty seconds, the inverted indicator will change back to the START button, and the ring of LEDs will turn off. The user may press START to reattempt to scan the Dry Light Adapter UVLrx Security tag, or press CANCEL to return to the Home Screen. WORKING 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page35of55 PreCalibrationScreen 7.1.5. ThePreCalibrationScreenrequirestheusertoconnectthePatientCabletotheCalibrationPort.Remove thedustcapfromtheCalibrationPort.FirmlysecurethePatientCablewiththetaperedadaptertothe CalibrationPort,andtwisttheSlipLockRingofthePatientCableuntilfirmlyseated.PressSTARTtoinitiate calibration. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page36of55 CalibrationScreen 7.1.6. ProgressiontotheCalibration Screenindicates the UVLrxStationisin processwith calibrationofeach wavelengthoftheUVLrxStation.Forperformancespecifications,seeSection14,TechnicalSpecifications. Note:Calibrationmaylastseveralseconds.Successfulcalibrationwillautomaticallytransitionthescreentothe Calibration Successful screen, followed by the PreTreatment Screen. If for any reason one or more of the wavelengths was not calibrated successfully, the screen will automatically transition to the Calibration Retry Screen.TheCalibrationRetryScreenwillbedescribedinSection9,Troubleshooting. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page37of55 CalibrationSuccessfulScreen 7.1.7. ProgressiontotheCalibrationSuccessfulscreenindicatestheUVLrxStationsuccessfullycalibratedeach wavelengthoftheUVLrxStation. ThisscreenwillautomaticallytransitiontothePreTreatmentScreenafterseveralseconds. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page38of55 7.2. STARTINGTREATMENT PreTreatmentScreen 7.2.1. ThePreTreatmentScreenallowstheusertoinitiatetreatment.PressingSTARTinitiatestreatment.Priorto initiatingtreatment,ensurethePatientCableisproperlyseatedontotheEmissionPortoftheUVLrxStation, theDLAisfirmlyseatedintothe20gax1catheter,andtheDLAisfirmlyseatedintothePatientCable. ThePreTreatmentScreenisshownbelow.PressingQUITwillendtreatmentandreturntheusertotheHome Screen. A countdown Treatment Timer is shown, which fills in white, counter clockwise as treatment progresses,from60minutesaroundtozerominutes.Threestatusbarsareshownwhichfillinfromleftto rightastreatmentprogresses.ULTRAVIOLETfillsinoverthefirst30minutes.Visible#1indicatesthe REDwavelength,andfillsinover60minutes.Visible#2indicatestheGREENwavelength,andfillsinover thesecond30minutesoftreatment.TheTreatmentStatusblockindicatestreatmentispaused. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page39of55 InTreatmentScreen 7.2.2. TheInTreatmentScreenisdisplayedaftertheuserpressesSTART,initiatingtreatment.Thescreenbelow showsthetreatmentafterthefirst15minutesoftreatmenthasprogressed.Atanytime,theusermaypress PAUSE to pause the treatment, or QUIT to end treatment and return to the Home Screen. Note the TreatmentStatusblockindicatesInProgress. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page40of55 TreatmentPausedScreen 7.2.3. The Treatment Paused screen is displayed after the user presses PAUSE. The screen below shows the treatmentafterthefirst45minutesoftreatmenthasprogressed.Atanytime,theusermaypressQUITto endtreatmentandreturntotheHomeScreen. TheusermaypressCONTINUEatanytimetocontinuewiththetreatment.ThePAUSE/CONTINUEcycle mayberepeatedasnecessarytoaccommodatethehealthcareproviderandpatient.Whentreatmentis paused,theTreatmentStatusindicatesPaused. Note:at30minutes,thedevicewillemitandaudibledoublebeep. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page41of55 TreatmentCompleteScreen 7.2.4. TheTreatmentCompletescreenisdisplayedafterthetreatmentends.Whenthetreatmentcompletes,the devicewillemitatriplebeep.TheusermustpressFINISHtoreturntotheHomeScreen. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page42of55 8. MAINTENANCE 8.1. UVLRXSTATION Thefusesaretheonlyuserserviceablecomponent.Seesection11Serviceforregularservicerequirements. DonotattempttosterilizetheUVLrxStation. 8.2. PATIENTCABLE RegularmaintenanceisnotrequiredfortheModelUVL1510,asidefromthosedescribedinSection3.2.1.Do notattempttosterilizethePatientCable.TherearenouserserviceablecomponentsforthePatientCable. 8.3. DRYLIGHTADAPTER RegularmaintenanceisnotrequiredfortheModelUVL1520.Therearenouserserviceablecomponentsfor theDryLightAdapter. 8.4. FUSES TheModelUVL1500requirestwo(2)fuses,eachratedat2ALand250VwithtimelagT.Ifthefusesrequire changing,disconnectACmainspowerfromthedevice,anduseaflatheadscrewdrivertopopopenthefuse trayfromthePowerEntryModuleatthebackofthedevice.Replacethefuses,andreplacethefusetray. Ensurethetrayiscompletelyseated.ReconnectACmainsandpresstheStandBySwitch.Ifthedevicedoes not turn on, disconnect power and verify the fuse tray is properly seated. The fuses are the only user serviceablecomponents. PrintedCircuitBoards,Plastics,Aluminum/Copper/Steel 8.5. DISPOSAL/ENVIRONMENTALDIRECTIVES WhenconsideringdisposaloftheUVLrxStationandaccessories(e.g.UVL1510andUVL1520),theusermust disposeofinaccordancewithlocallawsandordinancesgoverningsuchdisposal.UVLrxStationcontainsthe followingmaterials/componentswhichmaybeconsideredimportantfordisposal,including:
Contact UVLrx Therapeutics Inc. before disposing of UVLrx Station devices. Disposal of UVL1520 should followhealthcareproviderssharpsdisposalprocedures. ForcustomersinEuropeancountries:TheWEEEsymbolontheproductoritspackagingindicatesthatthis productmustnotbedisposedofwithotherwaste.Instead,itisyourresponsibilitytodisposeofyourwaste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and ElectronicEquipment.Theseparatecollectionandrecyclingofyourwasteequipmentatthetimeofdisposal willhelpconservenaturalresourcesandensurethatitisrecycledinamannerthatprotectshumanhealthand theenvironment.Formoreinformationaboutwhereyoucandropoffyourmedicalequipmentattheendof itsusefullifeforrecycling,pleasecontactUVLrxTherapeutics. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page43of55 9. TROUBLESHOOTING 9.1. CALIBRATIONINCOMPLETE Ifcalibrationisunsuccessful,theuserwillberoutedtotheCalibrationRetryScreen.Therewillbethree numbersdisplayedatthebottomofthescreen.Basedonthethreenumbers,dothefollowing:
(a) ErrorCode:999 a. ThiscodeindicatesthePatientCablewaseithernotconnectedtotheEmissionPort,thePatient CablewasnotconnectedtotheCalibrationPort,orboth.VerifythePatientCableisproperly connected at both ends to the UVLrx Station and press RETRY. The device will attempt to calibrateagain.IfcalibrationisstillunsuccessfulandtheuserisreturnedtotheCalibrationRetry Screen,tryinspectingandcleaningbothendsofthePatientCableandpressRETRY.Ifthisis unsuccessful,replace the PatientCableandpressRETRY.If thisisunsuccessful,contactyour authorizedUVLrxTherapeuticsservicecenter.
(b) ErrorCode:containsthenumber3 a. Thiscodeindicatesthatoneormoreofthewavelengthsisnotcalibratingproperly.Ifcalibration isstillunsuccessfulandtheuserisreturnedtotheCalibrationRetryScreen,tryinspectingand cleaning both ends of the Patient Cable and press RETRY. If this is unsuccessful, replace the Patient Cable and press RETRY. If this is unsuccessful, contact your authorized UVLrx Therapeuticsservicecenter. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page44of55 9.2. UVLRXSECURITYSCANNINGNONRESPONSIVE IntheeventthattheusersuspectstheUVLrxSecurityscanningfunctionisdisrupted,thefollowingsteps shouldbeattemptedpriortocontactingUVLrxTherapeuticscustomerservice:
(a) AttemptscanningeitheradifferentPatientCableorDryLightAdapter.
(b) PresstheStandBySwitchtoturnthedeviceoff.Powerthedevicebackon,andattempttoscanthe UVLrxSecuritytag(s)again.
(c) Powerthesystemdown,unplugthepowercord,waitforthreetofiveseconds,andreconnectthe powercord.Startthesystemagain,andattempttoscanthetag(s)again. 9.3. TOUCHSCREENNONRESPONSIVE Insomeinstances,theUVLrxStationisperforminginternaloperationsandthetouchscreenmaybecome unresponsiveforashortperiodoftime.Ifthisoccurs,waitafewseconds,andattemptpressingthebutton again. 9.4. LOSSOFPOWER IntheeventthattheUVLrxStationlosespoweratanypointinitsoperation,itisdesignedtonotrestart. TheusermustturnthedeviceONasusual,andgothroughthestepsfortreatmentsetupagain.Thedevice containsnointernalmemoryorrecordoftreatments,nopatientdata,andnousersettings. 9.5. MISCELLANEOUSERRORS ForerrorsnotspecificallycalledoutinSection9,TroubleShooting,powerthedeviceOFF.DisconnectAC mains power. Wait at least 30 seconds. Plug AC mains back into the device, power the device on, and determineiftheproblempersists. Forallservicequestions,pleasecontactyourUVLrxTherapeuticsauthorizedserviceprovider. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page45of55 10. TheUVLrxStationdoesnotrequiretheuseofprotectiveeyewear. PROTECTIVEEYEWEAR 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page46of55 SERVICE 11. The calibration procedure performed before each treatment provides a means of detection for immediate servicingrequirements.Generalinspectionandservicingisperformedinthecasewhereadeviceisreturnedfor service. Regularandpropermaintenanceofyourequipmentisthebestwaytoprotectyourinvestment.Itisessentialthat youhaveyourequipmentservicedonceevery12months,therecertification,inordertoretainitsoptimum performanceandreliability,whichwillrewardyouwithsafer,lessproblematicproductperformanceovertime. ServiceatUVLrxTherapeuticsauthorizedservicecentersonceevery12monthsismandatorytokeepyourproduct warrantiesineffect.Anyservicesand/orrepairsdonebyanyunauthorizedrepairfacilitymayresultinreduced performanceoftheequipmentorequipmentfailure.(Refertosection12Warranty). 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page47of55 LIMITEDWARRANTY 12. UVLrxTherapeuticsprovideswarrantyinformationinyoursalesagreementdocumentation.A1year limitedwarrantyisprovidedstandardwithnewModelUVL1500purchases.UVLrxTherapeuticsprovides optionalextendedwarrantyperiods,asdescribedinQF72016LimitedExtendedWarranty.Thelimited extendedwarrantyrequiresarecertification,orannualservice,beperformedatthestartoftheextended warrantyperiod. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page48of55 13. POINTOFCONTACT Forwarrantyorserviceconcerns,pleasecontact:
UVLrxTherapeuticsInc. Attn.WarrantyService 640BrookerCreekBlvd. Suite455 Oldsmar,FL34677 U.S.A. Tel.8778697553 Forquestionsregardingproperoperationofthedeviceoraccessories,questionsregardingextendedwarrantyorsales,and forreorderingDryLightAdapters,PatientCables,orreplacementcomponents,pleasecontact:
UVLrxTherapeuticsInc. Attn.CustomerService 200EastCarrilloStreet Suite101 SantaBarbara,CA93101 U.S.A. Tel.8778697553 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page49of55 14. TECHNICALSPECIFICATIONS 14.1. MODELUVL1500SYSTEMSPECIFICATIONS ACInputSupply MaxInputPower(peak) NominalInputPower Dimensions(inches) Weight(lbs.) Fuses TypeBFAppliedPart RiskGroupClassificationper62471 ElectricalSafetyClass WaterIngressionRating RFIDRadioFrequencyandEffectiveRadiatedPower 100240V,50/60Hz,withprotectiveearthing 48 W 14.5W 9.5tall x12wide x8.5deep(settingonflatsurface) 10 lbs.max. two250V,2A,Tlag EmissionPort Exempt ClassI IPX0 RFIDRadioFrequency: 13.56MHz ActionTime:Momentary,20secondsmax,duringRFID Tagidentification EffectiveRadiatedPower:75uV/m@3meters
*AdditionalStatementsRegardingRadioFrequencyEmissionsforUVL1500UVLrxStation:
ThisdevicecomplieswithIndustryCanadalicenceexemptRSSstandard(s).Operationissubjecttothefollowing twoconditions:(1)thisdevicemaynotcauseinterference,and(2)thisdevicemustacceptanyinterference, includinginterferencethatmaycauseundesiredoperationofthedevice. CetappareilestconformeavecIndustrieCanadaRSSexemptesdelicencestandard(s).Sonfonctionnementest soumisauxdeuxconditionssuivantes:(1)cedispositifnedoitpascauserd'interfrences,et(2)cetappareildoit acceptertouteinterfrence,ycompriscellespouvantcauserunmauvaisfonctionnementdel'appareil. 14.2. MODELUVL1500PERFORMANCESPECIFICATIONS 365nm10nm 1000 uW/cm2 20%
1800 mJ/cm2 20%
630nm10nm 270 uW/cm2 20%
972 mJ/cm2 20%
UVAPeakWavelength() UVAOutputIrradiance*
UVADosage**(30minutes) REDPeakWavelength() REDOutputIrradiance*
REDDosage**(60minutes) 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page50of55 GREENPeakWavelength() GREENOutputIrradiance*
GREENDosage**(30minutes) PulseFrequency LightSource(s) PowerSupply TreatmentDuration 530 nm20nm 225 uW/cm2 20%
405 mJ/cm2 20%
Continuous MonochromaticLightEmittingDiode(LED) 100240V,50/60Hz,12VDC,65Wmax IEC60601inputtooutputisolation,ClassBEMC,BF applicationapproval,dualfusing,4.5kVACisolation inputtooutput1.9kVACinputtogroundandoutput toground 60minutes
* Measuredasfollows:ModelUVL1500calibrationprotocolfollowed,thenModelUVL1510PatientCableconnected toModelUVL1520DryLightAdapter(DLA)whichinturnisconnectedto20gax1catheter.DLAwithcatheter placedintofixturealigningtipofcatheterlumenatapertureofintegrationcubewhichisconnectedtocalibrated spectrometer.Irradianceismeasuredasoutputinfinalconfiguration.
** Calculatedas:[irradiance(uW/cm2)xduration(minutes)x60seconds]1000=mJ/cm2 14.3. POWERCORDREQUIREMENTS ForEUuse,apowercordappropriatetotheregionmustbean8footmedicalgrade,18awgwire,3 conductor,andhaveanIECC13stylereceptacle.ThepowercordsuppliedbyUVLrxTherapeuticscontains aNEMA515Ptypeplug. 14.4. ACCESSORYTECHNICALSPECIFICATIONS:MODELUVL1510PATIENTCABLE Dimensions(meters) Weight(grams) 1.525 long 12 max 14.5. ACCESSORYTECHNICALSPECIFICATIONS:MODELUVL1520DRYLIGHT ADAPTER Dimensions(centimeters) Weight(grams) 17.2long(max)x2.54wide 3 max 14.6. LISTOFACCESSORIES The list of applicable accessories for the UVL1500 include the power cord (see section 14.3), the Model UVL1510 Patient Cable (see section 14.4), the Model UVL1520 Dry Light Adapter (see section 14.5), and standard 20 gauge x 1 catheter. 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page51of55 15. PRODUCTENVIRONMENTALREQUIREMENTS 15.1. MODELUVL1500&ACCESSORIESENVIRONMENTALTECHNICALSPECIFICATIONS:STORAGE ThefollowingrangesapplyfortheModelUVL1500,UVL1510,andUVL1520whilepackedfortransportorstorageinthe customshippingcaseoriginallyprovidedwiththeUVLrxStation:
AmbientTemperature(Celsius) RelativeHumidity(%)(noncondensing) AtmosphericPressure(hPa) 20to+70 10%to90%
500to1060 TheabovevaluesalsoapplytotheModelUVL1510(packedindividuallyinshippingboxforreplacementpatientcables)and theModelUVL1520(soldseparatelyinshippingbox). 15.2. MODELUVL1500&ACCESSORIESENVIRONMENTALTECHNICALSPECIFICATIONS:
OPERATION ThefollowingrangesapplywhileoperatingtheUVLrxStationinnormaluse. AmbientTemperature(Celsius) RelativeHumidity(%)(noncondensing) AtmosphericPressure(hPa)
+10to+35 30%to75%
700to1060 15.3. MODELUVL1500ELECTROMAGNETICREQUIREMENTS 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page52of55 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page53of55 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page54of55 2015UVLrxTherapeuticsInc.AllRightsReserved.Reproductionormodificationisstrictlyprohibited. 640006REVBModelUVL1500USERMANUAL Page55of55
1 | Label | ID Label/Location Info | 387.46 KiB | September 10 2015 |
UVLrx Therapeutics Inc. 640 Brooker Creek Blvd. Suite 455,Oldsmar, FL 34677 100 - 240 V 50 / 60 Hz Max Power: 48 VA Replace fuse as marked 2X T 2AL 250V i 710305 SN REF UVL1500 2015-1500-001 EC REP MDSS GmbH Schiffgraben 41 0 0 8 6 D-30175 Hannover, Germany Made in USA for Export Only 65-0011 REV D 09/15 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. ANSI/AAMI ES60601-1 CAN/CSA C22.2 No. 60601-1 www.uvlrx.com FCC ID: 2AFFF-UVL1500 IC ID: 20424-UVL1500
1 | Confidentiality Request Letter | Cover Letter(s) | 121.67 KiB | September 10 2015 |
Attn: Director of Certification Confidentiality Request regarding application for certification of FCC ID: 2AFFF-UVL1500 / IC ID: 20424-UVL1500. Pursuant to Sections 0.457 and 0.459 of the Commissions Rules, we hereby request confidential treatment of information accompanying this application as outlined below:
Exhibit Type Block Diagram Theory of Operation Schematics The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Name: Jeremy Pickens Title: Senior Engineer / Agent for UVLrx Therapeutics Inc. Date: 03 August 2015 File Name
(UVL1500) Block Diagram
(UVL1500) Operational Description
(UVL1500) Schematics SGS North America Inc. Consumer Testing Services 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.us.sgs.com/cts Member of the SGS Group (SGS SA)
1 | Letter of Authority | Cover Letter(s) | 309.51 KiB | September 10 2015 |
UVLrx Therapeutics Inc. 640 Brooker Creek Blvd. X Suite 455 THERAPEUTICS rp eee Attn: Director of Certification Authority to Act as Agent
| appoint Jeremy Pickens to act as our agent in the preparation of this application for equipment certification. | certify that submitted documents properly describe the device or system for which equipment certification is sought. | also certify that each unit manufactured, imported or marketed, as defined in Industry Canadas regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, |
acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by TIMCO, still resides with UVLrx Therapeutics Inc. Dated this 6" day of May, 2015. Agency Agreement Expiration Date: December 31%, 2015 By: Scot Johnson igNature) (Print name) Title: Program Manager On behalf of: UVLrx Therapeutics Inc. Telephone: 844-885-7979 Email: pm@uvirx.com 112414-23a
frequency | equipment class | purpose | ||
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1 | 2015-10-09 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2015-10-09
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1 | Applicant's complete, legal business name |
UVLrx Therapeutics Inc.
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1 | FCC Registration Number (FRN) |
0024574584
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1 | Physical Address |
640 Brooker Creek Blvd Suite 455
|
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1 |
640 Brooker Creek Blvd
|
|||||
1 |
Oldsmar, FL
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
T******@TIMCOENGR.COM
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AFFF
|
||||
1 | Equipment Product Code |
UVL1500
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
S****** J********
|
||||
1 | Telephone Number |
81384********
|
||||
1 | Fax Number |
84488********
|
||||
1 |
p******@uvlrx.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Intravenous Light Therapy Device | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
SGS North America, Consumer Testing Services
|
||||
1 | Name |
D******** S******
|
||||
1 | Telephone Number |
973-4********
|
||||
1 | Fax Number |
973 5********
|
||||
1 |
d******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC