EBR Systems 4100 4100 User Manual

EBR Systems Inc 4100

Contents

user manual

WiSE™CRTSystemINSTRUCTIONSFORUSETransmitterModel4100CAUTION‐InvestigationalDevice.LimitedbyUnitedStateslawtoinvestigationaluse.EBRSystems,Inc.480OakmeadParkwaySunnyvale,CA94085USAwww.ebrsystemsinc.com+14087201906support@ebrsystemsinc.comLBL‐03396‐IDE‐ENRev.C
 WiSECRTSystemTransmitterModel4100InstructionsforUse 1TableofContents1 Precautions...........................................................................................................................................21.1 SterileSingleUseDevices.............................................................................................................21.2 StorageandHandling....................................................................................................................21.3 Co‐ImplantedPacemaker,Defibrillator,orBiventricularDeviceCompatibility...........................21.4 Pre‐implantDeviceChecking........................................................................................................21.5 ImplantProcedure........................................................................................................................31.6 Programming.................................................................................................................................31.7 ExplantandDisposal.....................................................................................................................32 PriortoImplantingtheTransmitter......................................................................................................42.1 AssessingtheAcousticWindow....................................................................................................42.2 ReviewSpecificationsandConsiderationsfortheCo‐ImplantDevice.......................................133 ImplantingtheTransmitter.................................................................................................................153.1 OpeningSterileContainers.........................................................................................................153.2 CleaningandDisposalofDevices................................................................................................153.3 AssessingPatientandProceduralStatus....................................................................................163.4 ImplantProcedure......................................................................................................................174 TechnicalSpecifications......................................................................................................................284.1 TransmitterUltrasoundSpecifications.......................................................................................284.2 TransmitterPhysicalandMaterialSpecifications.......................................................................284.3 TransmitterShippedandResetValues.......................................................................................284.4 TransmitterParameterTolerances.............................................................................................294.5 TransmitterRadioSpecification..................................................................................................294.6 FederalCommunicationsCommission(FCC)..............................................................................295 WiSECRTSystemAcousticWindowScreeningForm.........................................................................30
2 WiSECRTSystemTransmitterModel4100InstructionsforUse1 PRECAUTIONSPRECAUTION–ForuseonlybyQualifiedMedicalPersonnelinprofessionalhealthcareenvironments:TheWiSECRT System is intended to be used by qualified cardiologist physicians and only in professional healthcarefacilities.EBRSystems,Inc.providesbothhands‐onpre‐clinicaltraininganddidactictraining.Beforeusingthesystem, contact EBR Systems to schedule a one‐daytraining session for implant operators. Obtaining propersurgicaltrainingandtechniqueistheresponsibilityoftheimplantingphysician.Atleastannually,reviewdidactictrainingmaterialssuppliedandpresentedbysupportpersonnelfromEBRSystems.Obtainingthistrainingpriorto implant procedures is a responsibility of the implanting physician. The information provided in theseinstructionsforuseandintheWiSECRTSystemInstructionsforUse(LBL‐02744‐IDE‐EN)shouldbeconsideredasarequiredsupplementforqualifiedandexperiencedmedicalprofessionals.1.1 STERILESINGLEUSEDEVICES TheWiSECRTTransmitterissterilizedviaethyleneoxidegasprocessesafterbeingpackaged.ReturnanypackagethatdoesnotappeartopresentasterilebarriertoEBRSystems. TheWiSECRTTransmitterisforSINGLEUSEonly.Donotattempttosterilizeandre‐useanyWiSECRTdevice.1.2 STORAGEANDHANDLING Devicesshouldbestoredintheiroriginalpackagesinadry,cleantemperature‐monitoredenvironment. Allowdevicestoacclimatetoroomtemperaturepriortoimplanting.1.3 CO‐IMPLANTEDPACEMAKER,DEFIBRILLATOR,ORBIVENTRICULARDEVICECOMPATIBILITY The WiSE CRT system is intended to be used to provide bi‐ventricular pacing in conjunction with a co‐implantedpacemaker,defibrillator,orbiventricularpacing device. Program theco‐implanteddevicetodeliverrightventricularpacingintheappropriatemodeandtimingintervalsettingsaswouldberequiredfor CRT; e.g. a dual chamber pacing modality that utilizes right atrial pacing unless the patient is inpermanentatrialfibrillation. Specificcapabilitiesandfeaturesoftheco‐implanteddevicemustbereviewedagainstcriteriadescribedintheReviewSpecificationsandConsiderationsfortheCo‐ImplantDevicesectionoftheseinstructionsforuse.ThismustbereviewedpriortoimplantingtheWiSECRTTransmitter.1.4 PRE‐IMPLANTDEVICECHECKING CheckthedevicepackagefortheUse‐byDate.DonotusedeviceswhicharepasttheUse‐byDatemarkedonthepackage. Inspectthedevicepackagefordamage.Donotusethedeviceifthepackaginghasbeendamaged,thesealshavebeenopened,orthepackagingiswet.ReturnanypackagetoEBRSystemsthatdoesnotappeartopresentasterilebarrier. Check the package contents against the content list of the label.  Do not use the device if all listedcomponentsarenotpresentinthepackage. Check that a pre‐implant transthoracic echocardiogram procedurewascompleted,thattheacousticwindowwasdocumented,andthattheinformationisavailableforselectingtheimplantlocationfortheTransmitter.
 WiSECRTSystemTransmitterModel4100InstructionsforUse 31.5 IMPLANTPROCEDURE Donotdamage/cuttheTransmitterCable.Usefingerstogripthe cable connector and insert into theBatteryconnector/headerblock;donotuseanyinstrumentstoholdorinsertthecableintotheheader.Donotkinkthecableduringhandlingorduringimplant.Donotleaveasharpbendradiusinthecableimplant.Donotallowthecableconnectortobecomewet. Carefuldissectionandbluntforcetunnelingisrequiredtoavoidriskofperforationoftheintercostal(ICS)muscleandintothethoraciccavity.1.6 PROGRAMMING UseonlytheEBRSystems,Inc.ProgrammertoattempttocommunicatewithandprogramtheWiSECRTSystem.1.7 EXPLANTANDDISPOSAL ProgramtheWiSECRToperationalmodetoOFFpriortoexplant. ReturnallexplanteddevicestoEBRSystemstoassistwithfulllife‐cycledevicetraceabilityandtoensuresafeandenvironmentallysensitivedisposal. CleananddisinfectWiSECRTdevicespriortosendingtoEBRSystems,Inc.
4 WiSECRTSystemTransmitterModel4100InstructionsforUse2 PRIORTOIMPLANTINGTHETRANSMITTER2.1 ASSESSINGTHEACOUSTICWINDOWAn acoustic window is commonly known in echocardiography as the location where a transthoracicechocardiography(TTE) probe is placed to view the heart.  The term “window”refers a lung‐free,cartilage‐freepathwayforultrasoundtotravelbetweentheprobeandtheheart.TheWiSECRTTransmittersendsultrasonicpulsesthroughthechestwalltotheElectrodeintheheartandthusmustbeimplantedinanadequateacousticwindow(atleast1cmspacingbetweencostalcartilages1by2.5cmwide)fortransmission of ultrasound. This window is typically in the 5thor6th intercostal spaces (ICS), lateral to the leftparasternalborder.Howeverduetoanatomicalvariabilityoccasionallythe4thor7thICSmaybeused.Figure1:TypicalacousticwindowoptionsforTransmitterimplantAscreeningproceduretoconfirmtheexistenceofanadequatelysizedacousticwindowmustbeperformedpriortotheTransmitterimplantprocedure.Thisscreeningisperformedusingacommercially‐availableechocardiographicimagingsystemequippedwithatransthoracicechocardiography(TTE)probeandvascularprobe.Thevascularprobeis required to accurately identify the location and spacing of the costal cartilages. The cardiac probe is used tovisualizethelocation(distanceandangle)oftargetElectrodeimplantsitesrelativetocandidateTransmitterimplantsites.ItisalsousedtoidentifythepointalongtheICSwherelungencroachmentoccurs.Thisscreeningprocedurecanbeperformedasanadjuncttostandardechocardiography,routinelyperformedpriortoCRTimplantation.Thelocationofthelungschangeswithpatientmovementandrespiration.Consequently,thescreeningisperformedinmultiplebodypositionstoensureadequateacousticwindowinallpostures.1ThetermcostalcartilageisusedratherthanribbecausetheTransmitter is typically implanted medial to thetransitionfromtrueribbonetocostalcartilage.Thistransitionoccursroughlyatthelocationofthenipple.ICS 4 ICS 5 ICS 6 ICS 7
 WiSECRTSystemTransmitterModel4100InstructionsforUse 5FORTHISSCREENINGPROCEDURE,YOUNEED: UltrasoundImagingDevicewithavascularprobeandcardiacprobe Ribbontapemeasure Surgicalmarkingpen AcousticWindowScreeningForm(seesection5)SCREENINGPROCEDURESTEPS:1. Startwiththepatientinsupineposture.Thisshouldincludealevelofbacktilttoappropriatelymimictheirnormalsleepingposture.2. Markthecenterlineofthesternum.3. Identifythelocationofthe5thcostalcartilage:Startatthefirstcostalcartilagewiththelongaxisofthevascular probe oriented in the superior‐inferior patient plane directly below the clavicleand continueinferiorlyuntilthe5thcostalcartilageisencountered.SeeFigure2.Figure2:Identifythelocationofthe5thcostalcartilage4. Maintainingthesuperior‐inferiororientationoftheprobeslowlysweepthevascularprobefrommedialtolateralwhilemaintainingthe5thcostalcartilagecenteredintheimage.Usethistechniquetodeterminethemediallateralcourseof5thcostalcartilage(e.g.straightvs.curvedinferiorvs.curvedsuperior).Markthecenterlineofthe5thcostalcartilage.SeeFigure3.Figure3:Determineandmarkthemediallateralcourseof5thcostalcartilageVascular probe
6 WiSECRTSystemTransmitterModel4100InstructionsforUse5. Movethevascularprobedowntothe6thcostalcartilageandrepeatthemedial‐lateralsweepoftheprobetodetermineandmarkthecenterlineofthe6thcostalcartilage.Asananatomicalreferencepoint,measureandrecordonthescreeningformthelengthfromthesuprasternalnotchtomid‐5thICS.SeeFigure4.IMPORTANT!Notethatthereiscommonlyanarrowingand/orconjoiningofthe6thand7thcostalcartilageapproximately 4‐8 cm from the mid sternal line. Appreciation of this anatomical landmark can avoidconfusionduringthescreeningprocedureandcanbeusefulasananatomicalreferencepoint.Figure4:Determineandmarkthemedial‐lateralcourseof6thcostalcartilage6. Whilemaintainingthevascularprobeoverthe6thcostalcartilage,movetheprobefarlateralofthemidsternal line prior to moving the probe down to the 7thcostal cartilage. This is important to avoid anypotentialconfusionfromthepotentialco‐joiningofthe6thand7thcostalcartilages.Repeatthemedial‐lateralsweepoftheprobetodetermineandmarkthelocationofthe7thcostalcartilage.SeeFigure5.Figure5:Determiningandmarkingthemedial‐lateralcourseof7thcostalcartilage
 WiSECRTSystemTransmitterModel4100InstructionsforUse 77. Basedonthemarksforthe5thand6thcostalcartilagesvisualizethecenterlineofthe5thICS.Thisishalfwaybetweenthetwolines.Startingatthesternumslowlysweepthevascularprobealongthecenterlineofthe5thICS.Makesurethattheprobeisorientedperpendiculartothecenterline.Determinewherethespacingbetweenthecostalcartilagesopensto1cm.Markthislocationwithalinespanningbetweenthe5thand6thcostalcartilagelines.SeeFigure6.Figure6: Withultrasoundassistance,markwherethe5thICSopensto1cmTheultrasoundimagedisplaysthecostalcartilages(annotatedCC)andthe5thICSwhichcanbeusedtodeterminethelocationwherethespacingbetweenthecostalcartilagesopensto1cm.8. Continuesweepinglaterallyalongthecenterlineofthe5thICSforapproximately6cmtoensurethata1cmspacingismaintained.Ifthereisanynarrowingtolessthan1cmoverthisdistancemarkthislocationwithalinespanningbetweenthe5thand6thcostalcartilagelines.SeeFigure7.Figure7:Ensure1cmspacingismaintainedalongthe5thICSforatleast6cm.CC CC
8 WiSECRTSystemTransmitterModel4100InstructionsforUse9. Repeatsteps7and8forthe6thICShoweverinsteadofstartingtheprocessatthesternum,starttheprocesslateraltoanyco‐joiningorspacinglessthan1cmofthe6thand7thcostalcartilages.SeeFigure8.Figure8:Markwherethe6thICSopensto1cmandensurethis1cmspacingalongICS.10. Switchovertothecardiacprobe.11. DeterminetheareaofICSthatisfreeoflungencroachmentandmarkaccordingly.11A. Placetheprobeinthe5thICSmedialtothe1cmopeningpoint.OrienttheprobesothefanbeamisparallelwiththedirectionoftheICS.SeeFigure9.Figure9:OrientprobesothefanbeamisparallelwiththedirectionoftheICS.
 WiSECRTSystemTransmitterModel4100InstructionsforUse 911B. Whilerequestingthepatienttomimicmoderatebutnotdeepinhalation,observetheultrasoundimageforthepresenceoflungencroachment.Thisistypicallyevidencedbyawhitereflectivelineencroachinglaterallyinthenear‐fieldwithafar‐fieldshadowing.11C. Ifthereisencroachmentseenoninitialplacement,theICSlengthistooshort(<2.5cm).NofurthermeasurementsoftheICSarerequired.11D. Ifencroachment isfromasuperiorratherthanlateraldirection,itmaypresentasgenerallypoorimagequality.Inthiscase,axialrotationoftheprobeisrequiredtovisualizethedistinctsignatureoflungencroachment.SeeFigure10.Figure10:OrientprobesothefanbeamisparallelwiththedirectionoftheICSTheultrasoundimageshowsthereflectionartifactduetolungencroachment(annotatedL)andassociatedshadow(annotatedS).Theshadowcansweepacrosstheultrasoundimageduringinhalation.11E. Ifnoencroachmentisseenoninitialplacement,slowlymovetheprobealongthecenterlineoftheICSuntilthefirstsignoflungencroachmentisseen.SeeFigure11.Figure11:MoveprobealongICScenterlineuntillungencroachmentisseenL S
10 WiSECRTSystemTransmitterModel4100InstructionsforUse11F. Oncelungencroachmentisseen,markthelocationofthelateralborderoftheprobewithalineextendingbetweentheupperandlowercostalcartilagelines.SeeFigure12.Figure12:Markthelungborderofthe5thICSacousticwindow12. Repeatstep11forthe6thICS.13. Repeatsteps11and12withthepatientinthefollowingpostures: Supinelayingonrightside Sitting StandingNOTE:Additionalmarkingisrequiredifthemeasuredlengthissmallerthanpreviouslymarked.14. Ifneitherthe5thor6thICSprovidealength>=2.5cm.Repeatthescreeningprocessforthe4thand7thICS.15. FortheICSspaceswithsufficientlength>=2.5cm,estimatetheangulationanddistancetopotentialimplantsitesfortheelectrode.15A. PlacethecardiacprobeoverthepotentialsiteforTransmitterimplantation.Theprobeshouldbeoriented with the fan beam parallel with the direction of the ICS with the probe normal to thecurvatureofthechestwall.SeeFigure13.Figure13:PlacethecardiacprobeoverthepotentialsiteforTransmitterimplantationDashed shapes represent potential sites for Transmitter and Battery implantation
 WiSECRTSystemTransmitterModel4100InstructionsforUse 1115B. UsingthecardiacprobeasaproxyfortheTransmitterangulationonceimplanted,holdtheprobeatthe estimated medial‐lateral angle that the Transmitter would naturally lay once implanted.SeeFigure14.Figure14:Positionprobeatestimatedmedial‐lateralangleTransmitterwouldnaturallylayonceimplanted15C. Whilemaintainingthemedial‐lateralangleoftheprobeintheabovestep15B,adjustthecranial‐caudalangleoftheprobetovisualizethetargetedelectrodeimplantsiteontheLVwallbecomesvisibleintheultrasoundimage.Fromaline,perpendiculartothechest,estimatethecranial‐caudalanglewherethetargetedelectrodeimplantsiteontheLVwallisvisible.SeeFigure15.Figure15:Adjustthecranial‐caudalangleoftheprobetovisualizethetargetedElectrodeimplantsite
12 WiSECRTSystemTransmitterModel4100InstructionsforUse15D. Holdingtheprobeatthemedial‐lateralandcranial‐caudalanglesnotedinabovesteps15Band15C,estimatethemedial‐lateralanglefromthecenterlineoftheechoimageandmeasurethedistanceintheechoimagefromtheapproximatelocationoftheanteriorsurfaceoftheintercostalmuscletothecandidateElectrodeimplantsiteofinterest.SeeFigure16.Figure16:Measuredistancetotheelectrodeimplantsiteofinterest15E. RecordthefollowingdataforeachcandidateICSonthescreeningform: Distancefrommidsternallineto1cmspacingofcostalcartilages ICSlength:Shortestdistance(acrossdifferentpostures)form1cmspacingofcostalcartilagestopointoflungencroachment LocationofassumedcandidateElectrodeimplantsite. LVwallthickness Estimatedmedial‐lateralangletocandidateElectrodeimplantsite Estimatedcranial‐caudalangletocandidateElectrodeimplantsite DistancetocandidateElectrodeimplantsiteIMPORTANT!WhenmultipleacousticwindowsareavailableforWiSECRTTransmitterimplantation,thedistanceandanglebetweentheTransmitterandElectrode,TransmitterimplantpositioningandtheICSdimensionsmustbeconsidered.Foroptimaltransmission,thedistanceshouldbe10cmorlesswithatransmissionangle(bothmedial‐lateral angle and cranial‐caudal angle) less than 30 degrees.  Positioning the Transmitter as medial as possibleminimizes the possibility of reduced performance due to lung encroachment and should always be a primaryobjective,regardlessoftheacousticwindowselected.TheICSwithlargerdimensionsshouldbefavored.IMPORTANT!ToconfirmtheTransmitterimplantationsite,ashortenedversionofthescreeningprocessmustberepeatedatthestartoftheimplantprocedurebeforesterilepreparationofthepatient(seesection3,ImplantingtheTransmitter).Candidate Electrode implant site Distance Medial-lateral angle Dashed shape represents the potential implant site for the Transmitter
 WiSECRTSystemTransmitterModel4100InstructionsforUse 132.2 REVIEWSPECIFICATIONSANDCONSIDERATIONSFORTHECO‐IMPLANTDEVICEWARNING–Co‐implantedPacemaker,Defibrillator,orBiventricularPacingUse:Warningsandcautionsrelatedtotheco‐implanteddevicewillapplytotheWiSECRTsystemafterimplant.Reviewco‐implantdevicetechnicalmanualsandinstructionsforuseforacompletedescriptionofwarningsandcautions.WiSECRTreplacesthepacingfunctionofacoronarysinus(CS)lead when used in conjunction with a typical,commercially‐available implanted pacemaker, defibrillator, or biventricular pacing device to achieve CardiacResynchronizationTherapy(CRT).TheWiSECRTSystemwilltriggeraleftventricular(LV)pacingpulseimmediatelyaftersensingtherightventricular(RV)pacingoutputfromthepacingleadoftheco‐implanteddevice.ReviewtheInstructionsforusethatisassociatedwiththeco‐implanteddevice.Programtheco‐implanteddevicetodeliverrightventricularpacingintheappropriatemodeandtimingintervalsettingsasrequiredforCRT.TheWiSECRTSystemfunctionalityreliesondetectionoftheRVpacingspikefromtheco‐implantdevice.TheWiSECRTmeasuresthepulsewidthofRVpacingsignalstosynchronizetotheRVpacingoutput.Insinglechamberpacingmodes this is straight forward, however, to do this reliably in dual chamber pacing modes, the system mustdistinguishrightventricularpacingfromrightatrial(RA)pacing.TheWiSECRTTransmittermustbeinitializedwiththepacingpulsewidthsbeingusedbytheco‐implanteddevice.Therightventricularpacingpulsewidthoftheco‐implantpacemakermustbeprogrammedatorabove0.35ms.Indualchambermodes,whereatrialpacingmaybeexpected,therightatrialpacingpulsewidthoftheco‐implantpacemakermustbeprogrammedatleast0.2msaboveorbelowtherightventricularpulsewidth.Insinglechamber,rightventricularpacingmodes,wherethereisnoatrialpacing,therightventricularpacingpulsewidthoftheco‐implantpacemakermustbeprogrammedatorabove0.35ms.CO‐IMPLANTSETTINGEXAMPLEMode RVPulseWidth RAPulseWidthDualChamber(e.g.DDD) 0.4ms ≤0.2msor≥0.6msSingleChamber(e.g.VVI) 0.4ms NotapplicableWiSECRTmaybeimplantedwithanyco‐implantedpacemaker,defibrillatororbiventricularpacingdevicewiththefollowingcapabilitiesandrequiredsettings: Rightventricularpacingleadimplantedandfunctional Programmedpacingmodalitythatutilizesrightventricularpacing Pacingpulsewidthsettingsfortherightventricularleadprogrammableabove0.35ms Separately programmable atrial pacing pulse width settings in dual chamber modes that allow fordifferencesof0.2msorgreaterthanthoseusedforrightventricularpacing AutoCaptureorleadimpedancemeasurementalgorithmsthatautomaticallyadjustthepulsewidthoftheco‐implantdevicemustbeprogrammedtoOFF Any other feature or operation, for example thoracic impedance sensing, that initiates an electricaloutputmustbeprogrammedtoOFFTheWiSECRTsystemwillsynchronizetotheco‐implantedRVpacingsignal(thepacingspike)andtrackratesupto140ppm(minimum430mspacinginterval).Pacingbytheco‐implanteddeviceabove140ppmwillinhibittheWiSECRTsystemfromprovidingbi‐ventricularpacinguntilthepacingratedropsbelow140ppm.Highratepacingbytheco‐implanteddevice,forexampleforpaceterminationofventriculartachycardia,mayresultinWiSECRTbi‐VpacingtheLV,butonlytoamaximumrateof140ppm.WARNING‐Co‐implantedCRT‐DorCRT‐Puse:Enablingcoronarysinuspacingfromaco‐implantedCRT‐PorCRT‐DwiththeWiSECRTmayinhibitWiSECRTpacing.Disablecoronarysinuspacingmodesinaco‐implantedCRT‐PorCRT‐Ddevice.
14 WiSECRTSystemTransmitterModel4100InstructionsforUseIMPORTANT! DuringtheElectrodeimplantprocedure,patientsshouldhavean external defibrillator attached.Ensurethatanyco‐implantanti‐tachytherapiesaredisabledorreprogrammedtoavoidhavingtheco‐implantdeliveranti‐tachytherapy.Thisalsoensuresthatperi‐proceduralpacingwiththeWiSECRTisnotsensedbytheco‐implant’sdetectionalgorithms.Aftertheprocedure,ensurethatanti‐tachytherapiesareenabledintheco‐implant.
 WiSECRTSystemTransmitterModel4100InstructionsforUse 153 IMPLANTINGTHETRANSMITTER3.1 OPENINGSTERILECONTAINERSTheTransmittermoduleisseparatelypackagedinadoubletray(atrayinsideatray)eachwithasterilebarriersealedlid.TheTransmittertraycontains: One Transmitter with a permanently integrated cable. Figure 17 illustrates the Transmitter’s top andbottomviews. Figure17:TransmitterModel4100,topandbottomviewsThefollowingshouldbeperformedcarefullytoensuresafehandlingontothesterilefield:1. CheckthedevicepackagefortheUse‐byDate.DonotusedeviceswhicharepasttheUse‐byDatemarkedonthepackage.2. Removethedevicetrayandthecontentsfromtheouterboxes.Retaintheregistrationmaterials.3. Checkthelabelonthetraylidtoensurethatthedevicenameand model number match the requireddevice.4. Inspectthedevicepackagefordamage.Donotusethedeviceifthepackaginghasbeendamaged,thesealshavebeenopened,orthepackagingiswet.5. Locatetheaccessiblecorneroftheoutertraylid,gripthepeelableedge,andpeelbackthecover.6. Theinnertrayanditscontentsaresterileandshouldberemovedbyasterileglovedhandandplacedonasterilesurface,orwithouttouching,byemptyingthecontentsofthepackageontoasterilesurface.7. Discardthetraysandcovers.3.2 CLEANINGANDDISPOSALOFDEVICESExplantedTransmitterdevicesshouldbewipedcleanusingtypicalhospitalcleaninganddisinfectingsolutionsandthensterilizedbyethyleneoxideprocessesusedbythehospital.AllexplantedTransmitterdevicesmustbereturnedtoEBRSystems.BOTTOM TOP Active transducer array area Sensors Sensor Attachment wing
16 WiSECRTSystemTransmitterModel4100InstructionsforUse3.3 ASSESSINGPATIENTANDPROCEDURALSTATUSThesubcutaneousimplantoftheTransmitterandBatteryareusuallyperformedbeforeimplantingtheElectrode.ThisorderofproceduresallowstheWiSECRTSystemtobestaligntheElectrodeimplantwiththelocationoftheTransmitter.SeetheWiSECRTSystemElectrodeInstructionsforUseforElectrodeimplantprocedures.PriortoTransmitterandBatteryimplantation,assessthepatient’sproceduralstatusforthefollowing:1. Toreducetheriskofexcessivebleeding,thepatient’sActivatedClottingTime(ACT)shouldbebelow180secondsbeforebeginningtheimplantoftheTransmitterandBattery.2. ThelocationfortheimplantoftheBatteryshouldbeselectedonthemid‐axillarylineofthepatient’slateralchestwall.3. WhenselectingtheimplantsitefortheBattery,accountforthe30cmlengthofthecablebetweentheTransmitterandtheBattery.ThedistancebetweentheimplantsitesoftheTransmitterandBatterymustbelessthan30cmsothatthecableconnectioncanbeeasilymadewithoutstrainingthecable.PatientmovementandcomfortshouldalsobeconsideredforBatteryimplantsiteselection.4. Preparetheleftchestandleftaxillaryforsterilesurgery.5. EnsuretheavailabilityoftheTransmitter,Battery,andProgrammer.
 WiSECRTSystemTransmitterModel4100InstructionsforUse 173.4 IMPLANTPROCEDUREInordertoachieveconsistentperformance,theTransmittermustbestablerelativetotheacousticwindowduringpatientmovementandrespiration.ThisrequirestheTransmittertobepositionedontheanteriorsurfaceoftheintercostalmuscle,beneathoverlyingmusclelayers.DependingontheICSused,thesemayincludepectoralis,rectusabdominus,serratus,and/orexternalobliquemusclelayers.TheTransmitterisstabilizedwithintheICSbysuturingthedevice’sattachmentwingtothecostalcartilage.TheTransmitterModel4100isimplantedtogetherwithandconnectedtoaWiSECRTBattery.SeetheWiSECRTSystemBatteryInstructionsforUseforadditionaldirectionsspecifictotheBattery.Figure18reflectsgeneralpositioningfortheTransmitterandBattery.TheTransmitterpositionwillbedependentontheselectedICS(typicallyinthe5thor6thICS,occasionallythe4thor7thICSmaybeused).ThecablemustexittheTransmitterpositionlaterally.TheBatterypositionistypicallyalongasuperior/inferiordirectiononthemid‐axillaryline. Figure18:TypicalpositioningfortheTransmitterandBatterySurgicaldissectiondowntotheanteriorsurfaceoftheintercostalmuscleisrequiredforthesubmuscularimplantandstabilizationoftheTransmitter.AchannelalongtheanteriorplaneoftheintercostalmuscleisformedasaconduitfromtheTransmitterincisiontotheBatterypocket.TheTransmitteristheninsertedintothemedialaspectofthischannel.CarefuldissectionandbluntforcetunnelingarerequiredtoavoidriskofperforationoftheICSmuscleandpleuralcavity.FORTHISIMPLANTPROCEDURE,YOUNEED: TransmitterModel4100 BatterycompatibleforusewiththeTransmitterModel4100 Programmerwithcompatiblesoftware Surgicaltoolsincluding:o Smallretractor(AESCULAPBT012Rorequivalent)o Tunnelingtool(AESCULAP‘RandalKidneyStoneForcep’EF051Rorequivalent)o Dilator(AESCULAP‘HegarUterineDilator’EM237Rorequivalent)o Spreader(AESCULAPBV104Rorequivalent) RoutingTube(Medline0.375”(9.5mm)SterileLatexPenroseDrain) Transmittersuturesandneedleholder(non‐absorbing2‐0sutureswithaTapercutneedle,EthiconV‐5orV‐7.Fordeepincisions,aneedleholderisrecommended,AESCULAP‘AdsonNeedleHolder’BM224R). Batterysutures(non‐absorbable2‐0/C‐15/26mmcuttingSynetureSS‐685Gsuture) UltrasoundImagingDevicewithavascularprobeandacardiacprobe CompletedAcousticWindowScreeningForm(seesection5)A B OR ICS 5 ICS 6
18 WiSECRTSystemTransmitterModel4100InstructionsforUseIMPLANTPROCEDURESTEPS:ConfirmingAcousticWindowandTransmitterImplantationSite1. Performashortenedversion of the screeningprocessatthestartofthe implant procedurebeforesterilepreparationofthepatient.ThisisrequiredtoconfirmtheTransmitterimplantlocationbecauseoftentimesthemarksfromthescreeningarenolongerpresentandeveniftheyarepresentthepatientisgenerallyinafullysupinepostureattheimplantdifferentfromthatusedduringscreening,makingthemarksinaccurate.Additionally,thisadditionalscreeningmustbeperformedwiththepatientsleftarmretractedbacktoexposethebatteryimplantsite,asisrequiredfortheimplant.Thisisimportantbecausemovementofthearmscanshiftthelocationofskinmarkings.SeeFigure19.Ataminimum,theshortenedscreeningshouldinclude: CountingofthecostalcartilageswiththevascularprobetoidentifythetargetICS Identificationofanyco‐joiningofthe6thand7thcostalcartilagesasananatomicalreference Identificationofthelocationwherethecostalcartilageopeningexceeds1cm ConfirmationofangulationanddistancefromtheICStocandidateelectrodeimplantlocationsIMPORTANT! The previously completed Acoustic Window Screening Form and associatedmeasurementsshouldbeusedasaguide.Figure19:Pre‐implantacousticwindowscreeningwithleftarmretractedPreparingtheTransmitterandBatteryImplantLocationsandCableChannel2. Makea4cmverticalskinincisionalongthemedialedgeoftheacousticwindowintheICSselectedfortheTransmitterimplant.3. Incisethroughthesubcutaneousfatuntilthefirstmusclelayerisexposed.4. Palpatetheoverlyingmusclelayertolocatethesuperiorcostalcartilage.Asasafetyconsideration,incisethroughthemusclelayersoverthesuperiorcostalcartilage.
 WiSECRTSystemTransmitterModel4100InstructionsforUse 195. Using the small retractor, retractthemusclelayerstovisually identify the anterior surface of thesuperiorcostalcartilage.SeeFigure20.Figure20:4cmverticalskinincisionalongmedialedgeofacousticwindowwithmusclelayersretractedtoexposeanteriorsurfaceofthesuperiorcostalcartilage6. Workingfromtheinferioredgeoftheexposedcartilage,usethesmallretractortoretractbacktheoverlying muscle to expose the anterior plane of the intercostal muscle. The intercostal muscle isidentifiableasafibroussheetofmusclerunningdiagonallybetweenthecostalcartilages.SeeFigure21.Figure21:Overlyingmuscleretractedtoexposetheanteriorplaneoftheintercostalmuscle7. Dissectthroughtheoverlyingmuscleinferiorlyexposingthefullspanoftheintercostalmusclebetweenthetwocostalcartilages.Oncetheinferiorcartilageisreachedexciseanymuscleinsertionsfromtheanteriorsurfaceoftheinferiorcostalcartilage.5th costal cartilage Pectoralis Rectus abdominis Intercostal muscle Intercostal muscle Small retractor Spreader
20 WiSECRTSystemTransmitterModel4100InstructionsforUse8. Insertthetunnelingtoolandadvancelaterallyintotheplanedefinedbytheanteriorsurfaceoftheintercostalmuscle.SeeFigure22.Figure22:AdvancingTunnelingTool9. Removespreaderasitcaninterferewithtunneling10. Orient the tunneling tool horizontaltothechest/sternumandadvance laterally along the anteriorsurfaceoftheICStotunneltowardthepreferredBatterypocketlocation.Avascularultrasoundprobecanbeusedtotrackthetipofthetunnelingtoolwithinthemusclelayers.Tunnelingresistanceshouldbeminimalalongthelayer.Ifresistanceisfeltretractthetunnelingtoolcompletelyandre‐assesstheinsertionsiteprior to repeating this tunnelingstep to ensurethatitislocatedover of the anteriorsurfaceoftheICSmuscle.SeeFigure23.Figure23:AdvanceTunnelingToolusingultrasoundassistance11. FormadevicepocketfortheBatteryimplantalongasuperior/inferiordirectiononthemid‐axillaryline.Thepocket’sincisionlengthshouldbeequaltotheBatterydimensionthatistobeinsertedintothepocket.ThepocketfortheBatteryisthenformedinferiortotheincision.Thepocketistypicallyformedbeneathsubcutaneousfatandsuperficialtotheabdominalmuscles,inamannerandsizingsimilartoconventionalpulsegeneratorpockets.IMPORTANT!Donotremoveprotectiveplugfromthebatteryheaderifperformingatestfitwiththebatteryinthepocket.Tunneling tool Tunneling tool Vascular probe
 WiSECRTSystemTransmitterModel4100InstructionsforUse 2112. Forproperstabilization,thetunnelmusttraversetheanteriorsurfaceoftheintercostalmuscleforatleast9cm.AfterthispointthetunnelingtoolcanbedirectedthroughanteriortissuelayersuntilthedistaltipofthetunnelingtoolenterstheBatterypocket.SeeFigure24.IMPORTANT!WhenselectingtheimplantsitefortheBattery,accountforthe30cmlengthofthecablebetweentheTransmitterandtheBattery.ThedistancebetweentheimplantsitesoftheTransmitterandBatterymustbelessthan30cmsothatthecableconnectioncanbeeasilymadewithoutstrainingthecable.PatientmovementandcomfortshouldbeconsideredforBatteryimplantsiteselection.Figure24:DirectTunnelingToolthroughintercostalmuscleandanteriortissuelayersfromTransmitterincisiontoBatterypocket13. TheRoutingTubeisusedasaconduitforroutingofthecable.Loopthetubethroughthedistaltipofthetunnelingtool.Pullthetunnelingtoolbackthroughthetunnel,leavingthetubeinplacetraversingbetweentheBatterypocketandTransmitterincision.SeeFigure25.IMPORTANT!UsethisRoutingTubemethodologytoavoiddamagingthecableconnector.DONOTroutethecablebypullingthecablethroughthechannelwithsurgicalinstruments.NEVERgraspthecableorcableconnectorwithsurgicalinstruments Figure25:PlaceRoutingTubeforuseinTransmitterimplantRouting tube Routing tube
22 WiSECRTSystemTransmitterModel4100InstructionsforUsePositioningandSecuringtheTransmitter14. Inordertopreventshiftingofthetransmitterwithpatientmovement,theattachmentwingsoftheTransmittermustbeplacedontheanteriorsurfaceofthecostalcartilagewithnomusclebetweenthewingsandthecostalcartilage.Usingthesmallretractor,exposeasufficientareaofthecostalcartilagetoaccommodatetheattachmentwings.15. The Transmitter must be permanently secured within a tight space to minimize movement of thedevice.FollowingthecourseofthetunnelandwiththeRoutingTubeinplace,advancethedilatorapproximately7cmtoformasmallspaceforthebodyoftheTransmitter.SeeFigure26.IMPORTANT!DonotformapocketfortheTransmitter,usingtools,fingersorothermeans,asthiswillleadtoanoversizedareaforthe Transmitter, reducing its stability, and potentially impactingperformanceandbatterylifeoftheimplantedsystem.Figure26:Advancedilator7cmtoformasmallspacefortheTransmitter’sbodyDilator
 WiSECRTSystemTransmitterModel4100InstructionsforUse 2316. InserttheTransmitter’scableintotheRoutingTube.SlidetheTransmitterintothetunnelwhilealsopullingtheRoutingTubefromtheBatterypocket.SeeFigure27.IMPORTANT!HandletheTransmittercablecarefully. Donotdamage/cuttheTransmittercable. UsefingerstogripthecableconnectorandinsertintotheBatteryconnector/headerblock;donotuseanyinstrumentstoholdorinsertthecableintotheheader. Donotkinkthecableduringhandlingorduringimplant. Donotleaveasharpbendradiusinthecableimplant. Donotallowthecableconnectortobecomewet. Donotsuturearoundorthroughthecable Figure27:UsetheRoutingTubetodirecttheTransmittercableintoplace17. RemovetheRoutingTubefromtheTransmittertunnel,leavingtheTransmitterandcableinplace.
24 WiSECRTSystemTransmitterModel4100InstructionsforUse18. PositiontheTransmitterasmedialinthechannelaspossiblewhilemaintainingastablepositionoftheattachmentwingsontopofthecostalcartilages.TheTransmitterwiththelabelshouldbefacingupandtheattachmentwingsonthetopoftheTransmittershouldspanthetwoadjacentcartilages.SeeFigure28. Figure28:PositioningtheTransmitterintothetunnel19. Retractanymuscletissueundertheattachmentwingsthatpreventsthewingsfromsittingdirectlyontopofthecostalcartilages.SeeFigure29.Figure29:EnsuretheTransmitter’sattachmentwingssitdirectlyontopofthecostalcartilages
 WiSECRTSystemTransmitterModel4100InstructionsforUse 2520. TheTransmitterissecuredwithintheICSwithsuturesplacedthroughtheouterlayer(perichondrium)ofthecostalcartilageandtiedovertheattachmentwings.Fordeepincisions,usetheneedleholder.Engagethesutureneedlethroughtheperichondriumofthecostalcartilage.Installaminimumof1sutureintothesuperiorcostalcartilageandaminimumof1sutureintotheinferiorcostalcartilage.Toaccommodate variations in the curvature and profile of the costal cartilages, the sutures can beinstalledanywherearoundtheperimeteroftheattachmentwings.topreventTransmittermovement,tightenallsuturessuchthattheyengagethecatchfeaturesontheinternalsurfaceoftheattachmentwings.SeeFigure30.Figure30:SecuretheTransmitterwithsuturestiedovertheattachmentwingsConnectingtheTransmitterCabletotheBattery21. TheBatterytraycontainstheBatterywithaprotectiveplugintheheaderblockandcontainsatorquewrench(seeFigure31).Toremovetheprotectiveplugfromthe Batteryheader,insertthetorquewrenchintothescrewportandloosen(counterclockwise)thesetscrewbycarefullyunscrewingonlytwo(2)completerotations.Pulltheprotectiveplugfromtheheaderanddiscard.IMPORTANT!Anytimeitisnecessarytoloosenthesetscrew,takecarenottodisengagethescrewfromtheport.Figure31:RemoveprotectiveplugfromBatteryExample placement of sutures Torque wrench (included in Battery sterile tray) Protective plug Screw port Suture holes Battery header block
26 WiSECRTSystemTransmitterModel4100InstructionsforUse22. Inspecttheendofthecableconnector.Ifanyfluidsarepresentontheconnectorcontacts,carefullywipedry.23. InspecttheBatteryheader.Ensurethatthereisnofluidorothermaterialinsidetheconnectorblock.24. InsertthecableconnectorstraightintotheheaderblockoftheBatteryuntilitisfullyseated.25. Visuallyinspecttheheaderblockandverifythatthereisonlyasmallgap (approximately1mm,asshowninFigure32)betweenthecablestrainreliefandthebatteryheaderblock.Ifthegapappearslarger,loosenthesetscrewin½turnincrementswhileattemptingtoinserttheconnectorfullyintothebatteryheader.Figure32:InspectcableconnectiontoBattery26. Insertthetorquewrenchintothescrewportandtightenthescrew.IMPORTANT!Thescrewmustbetightenedwiththetorquewrenchuntilthewrenchemitsanaudibleclick.Thisaudibleclickindicatesthatthescrewisfullyseated.ConfirmingfunctionalWiSECRTSystemwiththeProgrammer27. OntheWiSEProgrammer,selecttheCONNECTscreenfromthemainmenu,thenpressSEARCH.TheProgrammershouldfindtheTransmitteranddisplayitbyserialnumber.SelectthedevicethenpressCONNECT,andconfirmthattheProgrammerconnectstotheTransmitterthendisplaysadevicereportscreen.SeetheWiSECRTSystemProgrammerInstructionsforUseforsetup and operatinginstructions.An approximate 1 mm gap is visible when connection is properly made
 WiSECRTSystemTransmitterModel4100InstructionsforUse 27PositioningtheBatteryinthePocket28. Checkthatthecableissecuredinplacebythesetscrewbygentlytryingtodisconnectthecable.29. LooselycoilanyexcesscableundertheBatteryensuringthatthecableisnottwistedorkinked.30. InserttheBatteryandcableintothepocketsuchthattheconnectorblockisnearthetopofthepocket,thelogo sideisfacinganterior(up)andanyextracableiscoiledunderneaththebattery.ConsiderpatientcomfortwhendeterminingtheorientationoftheBatteryinthepocket.Visualizethelocationofthesutureholesinthebatteryheaderandidentifyproximaltissueforinstallationofsutures.31. Removethebatteryandcablefromthepocketwhilemaintainingthesamerotationofthebatteryandcablecoilingifpossible.SecuringtheBatteryintheBatteryPocket32. TheBatterymustbepermanentlysecuredwithinthepockettominimizemovementofthedevice.TheBatteryheaderblockcontainstwosutureholesforthispurpose(seeFigure31).SuturesareusedtosecuretheBattery.Thesutureholeshavebeensizedfora2‐0/C‐15/26mmcuttingSynetureSS‐685Gsuture.Usinganon‐absorbablesuture,installandtieofftwosuturesatthetissuelocationsidentifiedinstep30.33. Threadoneendofeachtiedoffsuturethroughthesutureholesinthebatteryheader.34. Insertthecoiledcableandbatterybackintothepocket,slidingthebatterydownoverthetied offsutures.35. Tightenandtieoffbothsuturescheckingtomakesurethattheyarenotpinchinganyportionofthecable.CompletingImplantationoftheTransmitterandBattery36. FlushtheTransmitterincisionandBatterypocketwithsterilesaline.37. SutureclosedtheBatterypocketandthentheTransmitterincision.38. For the Transmitter incision, suture the overlying muscle layersovertheTransmittersuchthattheTransmitterissecuredbeneaththeoverlyingmuscles.ItisimportanttoremoveanyairfromboththeTransmitter and Battery implantation sites. While suturing closedtheBatterypocket,pressonthepockettoforceairupandouttheTransmitterpocket.RemoveanyairfromtheTransmitterincisionwhilesuturingitclosed.39. SutureclosedtheskinlayersoftheTransmitterIncisionandBatterypocket.40. CompleteandreviewtheregistrationmaterialsprovidedinthepackagingandreturnthecompletedregistrationformstoEBRSystems
28 WiSECRTSystemTransmitterModel4100InstructionsforUse4 TECHNICALSPECIFICATIONS4.1 TRANSMITTERULTRASOUNDSPECIFICATIONSTRANSMISSIONVALUESUltrasoundfrequency 921.25kHzTargetingzone 90deg(+/‐45deg);range3‐16cmTargetingtransmissionspercardiaccycle Rate:1‐2kHz(typical)Burstspercardiaccycle:5(typical)‐128(max)Pulsewidthrange:16µsPacingtransmission Rate:2.33Hz(max)Burstspercardiaccycle:1Pulsewidthrange:0.01ms–4.4msEXPOSURELEVEL   MechanicalIndex Ispta(mW/cm2) Isppa(W/cm2)GlobalMaximum 0.43 49.6 4.44Nominal 0.17 0.34 0.654.2 TRANSMITTERPHYSICALANDMATERIALSPECIFICATIONSTRANSMITTERMODEL4100ANDCABLEVolume(Enclosure) 6ccWidthxHeightxThickness(Enclosure) 17.4x83.0x6.8mmLengthxDiameter–Volume(Cabling) 300mmx4mm(12F)–4ccMass 22.8gSensingelectrodearea‐Material 2.1mm2–Platinum/IridiumNumberofsenseelectrodes 4Adjacentsenseelectrodespacing Verticalpairspacing:16mmHorizontalpairspacing:51mmFront‐Backpairspacing:7mmPatientcontactmaterials Titanium,Alumina,Platinum/Iridium,Epoxy,Silicone,Polyethylene,Parylene4.3 TRANSMITTERSHIPPEDANDRESETVALUESPERMINENTPARAMETERS Shipped ResetMode OFF SavedMemoryTransmitLevel 1 SavedMemoryPulseWidth(ms) 0.4 SavedMemoryRVPacingSpikeDetection Notinitialized SavedMemoryDATA Shipped ResetPatientInformation Cleared SavedMemorySystemCounters Cleared ClearedTEMPORARYVOOPARAMETERS Shipped ResetPacingRate(bpm) 70 SavedMemoryTransmitLevel 1 SavedMemoryPulseWidth(ms) 0.4 SavedMemory
 WiSECRTSystemTransmitterModel4100InstructionsforUse 294.4 TRANSMITTERPARAMETERTOLERANCESOPERATIONALTIMING Range ToleranceSensedPulseWidthMeasurements(ms) 0.35–2.0 ±30.5µsTransmitPulseWidth(ms) 0.07–4.4 ±1.1µsVOOPacingIntervals(ms) 400–2000 ±TargetdelayNominalSynch/TargetingDelay(ms) 3 MaxSynch/TargetingDelay(ms) 12.55 CO‐IMPLANTPULSECHARACTERISTICS Range TolerancePulseWidthAccuracy  ±40µsor±5%PulseWidthLeadingEdgeRise <10µs ChargeBalanceEdgeDelay <200µs NoPulseOutputafterRVPace(ms) >100 4.5 TRANSMITTERRADIOSPECIFICATIONRADIOOUTPUTPOWERLowFrequency HighFrequency RatedRFPowerOutputMedicalImplantComm.Service(MICS) 402Mhz 405Mhz 447uW4.6 FEDERALCOMMUNICATIONSCOMMISSION(FCC)TheFCCIDforthisdeviceis2AMRX‐4100.Thisdevicemaynotinterferewithstationsoperatinginthe400.150‐406.000MHzbandinthemeteorologicalaids,meteorological‐satellite, and earth exploration‐satellite services, and must accept any interference received,includinginterferencethatmaycauseundesiredoperation.
30 WiSECRTSystemTransmitterModel4100InstructionsforUse5 WISECRTSYSTEMACOUSTICWINDOWSCREENINGFORMPatientIDScreeningPerformedByDateAcousticWindowLocation ICSReferenceMeasurementICSHorizontal distance from midsternal line to 1 cm ICS width spacing of costal cartilages Suprasternal notch to mid-5th ICS (noted C length) 5thICS(notedA‐5length) _________cm6thICS(notedA‐6length)  ______thICS  AcousticWindowLength:From1cmICSwidthlocationtolossofimageduetolungencroachmentorICSwidth<1cmICS Supine Acoustic Window Length Right Side Acoustic Window Length Sitting/Standing Acoustic Window Length Shortest Acoustic Window Length Recorded Is acoustic window adequate? Shortest length ≥ 2.5 cm? 5thICS(notedB‐5length) YesNo6thICS(notedB‐6length) YesNo______thICS YesNoCandidateImplantSiteInformationICS Location LV Wall Thickness ≥ 5 mm? Medial-lateral Angle Cranial-caudal Angle Distance 5thICS YesNo6thICS YesNo______thICS YesNoComments:A-5A-6B-5CB-6
©2017EBRSystems,Inc.AllRightsReserved.WiSEisatrademarkofEBRSystems,Inc.

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