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SpecificationsandConsiderationsfortheCo‐ImplantDevice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packagingis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withfull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6
th 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Electrodeimplant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theTransmitter 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5thcostalcartilage:Startatthefirstcostalcartilagewiththelongaxisofthe
vascular probe oriented in the superior‐inferior patient plane directly below the clavicleand 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5thcostalcartilage(e.g.straightvs.curvedinferiorvs.curvedsuperior).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locationwith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tomimic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distancetopotentialimplant
sitesfortheelectrode.
15A. PlacethecardiacprobeoverthepotentialsiteforTransmitterimplantation.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theabove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ofRV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 I
MPLANTINGTHE
T
RANSMITTER
3.1 O
PENING
S
TERILE
C
ONTAINERS
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nameand model number match the required
device.
4. Inspectthedevicepackagefordamage.Donotusethedeviceifthepackaging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 C
LEANINGAND
D
ISPOSALOF
D
EVICES
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
A
ttachment wing
16 WiSECRTSystemTransmitterModel4100InstructionsforUse
3.3 A
SSESSING
P
ATIENTAND
P
ROCEDURAL
S
TATUS
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)shouldbebelow180
secondsbeforebeginningtheimplantoftheTransmitterandBattery.
2. ThelocationfortheimplantoftheBatteryshouldbeselectedon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 I
MPLANT
P
ROCEDURE
Inordertoachieveconsistentperformance,theTransmittermustbestablerelativetotheacousticwindowduring
patientmovementandrespiration.ThisrequirestheTransmitterto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
IMPLANTPROCEDURE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differentfrom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theacoustic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
retracto
r
Spreade
r
20 WiSECRTSystemTransmitterModel4100InstructionsforUse
8. Insertthetunnelingtoolandadvancelaterallyintotheplanedefined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 ensurethat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directedthrough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thecable
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inplace,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

Dilato
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onthe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notto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onlya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mainmenu,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Batteryin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frequency921.25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interferencethatmaycauseundesiredoperation.

30 WiSECRTSystemTransmitterModel4100InstructionsforUse
5 WISECRTSYSTEM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)
5
th
ICS(notedA‐5length) 
_________cm
6
th
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
A
coustic Window Length
Right Side
A
coustic Window Length
Sitting/Standing
A
coustic Window Length
Shortest Acoustic Window
Length Recorded
Is acoustic window adequate?
Shortest length ≥ 2.5 cm?
5
th
ICS(notedB‐5length) 
YesNo
6
th
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
A
ngle Distance
5
th
ICS YesNo
6
th
ICS YesNo
______
th
ICS YesNo
Comments:
A
-
5
A
-
6
B
-
5
C
B
-
6


©2017EBRSystems,Inc.
AllRightsReserved.
WiSEisatrademarkofEBRSystems,Inc.

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