Boston Scientific RHYTHMIA HDx User manual

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Mapping System
SoftwareInstructionsforUse.......................2
Instruccionesdeusodel software...........106
Moded’emploi dulogiciel....................... 221
GebrauchsanweisungderSoftware........338
Istruzioniper l’uso delsoftware..............453
Gebruiksaanwijzingsoftware..................566
InstruçõesdeUtilizaçãodo Software.....680
RHYTHMIA HDx™

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TABLEOFCONTENTS
1. DEVICEDESCRIPTION................................................................... 4
1.1 Contents.......................................................................... 4
1.1.1 SignalStation(SiS) ............................................................4
1.1.2 SystemSoftware ..............................................................4
1.1.3 Workstation ..................................................................4
1.1.4 Accessories...................................................................4
1.1.5 IntendedApplied Parts.........................................................5
1.2 OperatingPrinciple ................................................................ 5
1.2.1 ContinuousMapping...........................................................5
1.2.2 ContinuousCatheterLocalization andTracking.....................................5
1.3 UserInformation................................................................... 5
2. INTENDEDUSE......................................................................... 5
3. INDICATIONSFORUSE.................................................................. 6
4. CLINICALBENEFITSSTATEMENT ......................................................... 6
5. CONTRAINDICATIONS .................................................................. 6
6. WARNINGS............................................................................ 6
7. CAUTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.1 General........................................................................... 7
7.2 DuringtheProcedure............................................................... 7
8. POTENTIALADVERSEEVENTS ........................................................... 8
8.1 Arrhythmias....................................................................... 8
8.2 Misinterpretationof Data ........................................................... 8
8.3 ElectricalHazards .................................................................. 8
9. HOWSUPPLIED ........................................................................ 9
10. MAJOROPERATINGMODES............................................................. 9
10.1 StudyLogIn....................................................................... 9
10.2 Overview ......................................................................... 9
10.3 LiveMode ....................................................................... 10
10.3.1 Setup Screen ................................................................11
10.3.2 Multiple MonitorConfiguration.................................................14
10.3.3 PreparingIntellaMapOrionFamilyofCathetersforUse.............................16
10.3.4 MapTab ....................................................................17
10.3.5 AblationTab.................................................................31
10.3.6 3DMappingOverview ........................................................31

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10.3.7 Mapping with Cathetersotherthan IntellaMapOrionFamilyofCatheters .............41
10.3.8 MapTaggingandEditing......................................................42
10.3.9 CatheterLocation Tracking.....................................................60
10.3.10 DirectSense .................................................................66
10.3.11 Ablation Generator DataDisplay................................................70
10.3.12 ForceSensing................................................................71
10.3.13 LUMIPOINTModule...........................................................77
10.3.14 Image Import................................................................83
10.4 ReviewMode..................................................................... 84
10.4.1 DynamicReview .............................................................85
10.4.2 Display ofLiveor RecordedCatheterLocationsin3DView ..........................85
10.4.3 Roving Probe ................................................................85
10.4.4 ShowingEarliestPoint(s) ofActivation...........................................86
10.4.5 MapEditing .................................................................86
10.5 Study Archivingand Export......................................................... 87
10.5.1 MATLAB Export ..............................................................88
10.6 ConfigureMode .................................................................. 89
10.6.1 FileShares ..................................................................89
10.7 SystemSettings .................................................................. 92
11. SOFTWARE TROUBLESHOOTINGGUIDE ................................................. 93
12. WARRANTY.......................................................................... 103
13. CONTACTS ........................................................................... 103
14. SYMBOLS FOUNDONRHYTHMIA HDxDEVICES ANDLABELING.......................... 104

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ONLY
Caution:FederalLaw(USA) restrictsthis devicetosaleby or ontheorderofa physician.
127(ɰ Allfeatures withintheseInstructions forUsemay notbe availableinyour applicabledevice.
1. DEVICEDESCRIPTION
1.1 Contents
1.1.1 SignalStation(SiS)
Thesignal station(SiS)acceptssignalsfromtheintracardiaccathetersandECG
electrodesusedduringEP procedures.It amplifiesanddigitizesthesesignals and
transfers themtotheWorkstationforreal-timeprocessing anddisplay.The SiSalso
supportscatheterlocalization(tracking)anddiagnosticstimulation.
Referto
RHYTHMIAHDxMappingSystem Hardware Instructions forUse for further
information.
1.1.2 SystemSoftware
Rhythmiasoftwareruns ontheWorkstation.It processes datareceivedfromtheSiS
andprovidesauser interfaceforsystem operation.Italsoperformsthe following
majorfunctions:
• ECGandintracardiac signaldisplay
• Catheterlocalizationandtracking
• 3Dmapping and visualization
• Diagnosticstimulation routing
1.1.3 Workstation
TheWorkstation comprisesbothcomputerhardware(e.g.,computer,monitor,
keyboard,mouse,andpowercords)andsystem software.In additiontooperatingthe
systemsoftware,theWorkstationcanalsostore,retrieve,andexportstudy data.
1.1.4 Accessories
• SiSpower supply
• ECGinputand output cables,AAMIand IECvariants
• Breakoutboxesandconnectingcables
• Intracardiacoutput cables
• Stimulatorinputjumper cables
• Patchcable
• Localizationgeneratorandconnectingcable
• Equipotentialcable
• Foot switch
• Fiberoptic datacable
• Workstationcomputer,monitor,andpowercords
• Workstationablation dataperipherals

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1.1.5 IntendedApplied Parts
Thefollowing single-useappliedpartsareintendedforusewith the systembut are
notincluded withthesystem:
• EPcatheters,including theIntellaMapOrion™ familyof catheters
• Locationreferencepatchkit
Note: CarefullyreadrespectivedeviceInstructions forUse beforeusingthesepartsin
anEP study.
1.2 OperatingPrinciple
TheRHYTHMIA HDx™ MappingSystem(thesystem)isa3D mapping andnavigation
systemused inelectrophysiological (EP)procedures.Thesystememploystwo
mechanismsto perform3Dmapping andnavigation:(
a. )continuousmapping
basedon patientcardiac signalsacquired fromintracardiaccathetersandsurface
ECGelectrodes,and(
b. )continuouslocalizationofmagneticand impedancetracked
catheters.These mechanismsaredescribedingreaterdetailbelow.
1.2.1 ContinuousMapping
Thecontinuousmappingfeatureemploys user-determinedbeat acceptancecriteriato
determinewhichbeatsareincluded intothemap.As theusertraversesthemapping
catheteraroundthechamber,thesoftware willcontinuouslyaddorreject beatstothe
mapbased on conformancetothe beatacceptancecriteria.Themapsaredisplayedas
colorcodedmaps.
1.2.2 ContinuousCatheterLocalization and Tracking
Thesystem enablesthetrackingofcathetersthroughtheuseofmagnetic–and
impedance-basedlocalizationtechnologies.
Magnetic-based localization uses a magneticlocationsensorembedded in
magneticallytrackedcatheters tomeasuremagneticfieldsgeneratedbyalocalization
generatorlocated beneaththepatient table.These magneticfieldsensor readingsare
passedtothesystemsoftware whichinturnuses thedatatodetermineanddisplay
theposition of thecatheter.
Impedance-based localization operatesbydrivingsmallcurrentsbetweenmultiple
surfaceelectrodesand measuringthevoltage oneachelectrodeofa tracked
impedancecatheter.Thesevoltagevalues arepassedtothesystemsoftwarewhichin
turnuses the datato determineand displaytheposition ofthecatheter.
1.3 UserInformation
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mappingspecialists.Onlyuserswho meetthesecriteriashouldusethe system.
2. INTENDEDUSE
TheRHYTHMIA HDx MappingSystem(thesystem)isa3D mapping andnavigationsystemusedin EP
procedures.TheSiSand related accessories providedataconnectionpathwaysforexternal input/output
devices(e.g.catheters andrecordingsystems)andserveasthedataconduittothesystemworkstation
andsoftware.

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3. INDICATIONS FORUSE
TheRHYTHMIA HDx MappingSystemandaccessoriesareindicated forcatheter-basedatrial and
ventricularmapping.Themappingsystemallowsreal-timevisualizationof intracardiaccathetersaswell
asdisplay of cardiacmapsina numberofdifferentformats.The acquired patientsignals,includingbody
surfaceECG andintracardiacelectrograms,mayalsoberecordedanddisplayed on thesystem’sdisplay
screen.
4. CLINICALBENEFITSSTATEMENT
TheRHYTHMIA HDx MappingSystemisaneffectivediagnostictoolforcardiacelectrophysiology
(EP)procedures.Whenused with theIntellaMapOrion mappingcathetersorthe IntellaNavablation
catheters,the RHYTHMIAHDxMapping Systemprovidesreal-timevisualizationof intracardiaccatheters
anda display ofcardiac mapsinselected formatsin minimallyinvasiveprocedurestoassistthe
physicianin identifying theoriginof the arrhythmiawithinthe heart chamber.Acquisitionofthe 3-D
electroanatomicalmapsand otherpatientinformationsuch assurfaceECGandintracardiacelectrograms
ona display screenprovidesdiagnostic informationtothephysicianforanoverallclinical benefitto
identifyand treatcardiacarrhythmias.Conversely,failure totreat acardiac arrhythmiacouldresultin
symptomssuchasshortnessof breath,palpitations,dizziness,syncope,chestpain,stroke orsudden
cardiac death.
5. CONTRAINDICATIONS
Thereareno knowncontraindications.
6. WARNINGS
TheRHYTHMIA HDx MappingSystem(thesystem)isintendedforusewith othermedicaldevicesin an
EPlaboratory.Carefullyreadthe InstructionsforUse(IFU)documentsforevery medicaldevicethatwillbe
usedduring a study,priortoeach study.Observe allcontraindications,warnings,and cautions.Failureto
doso may resultin userharm,patientillness,injury,ordeath.
• Carefullyreadthis entiredocumentand allotherproductIFUs before beginningthe mappingstudy.
Besuretofully understandand consistentlyfollowall warnings,cautions,andinstructions.Failure to
properlyfollow theinstructionsmaycauseequipment damage,systemmalfunction,or harmtothe
patientoruser.
• To ensurecorrectclinicaldecisions,usefluoroscopy,ultrasound,pacemappingor othervisualization
techniquestoverifymapping resultsandcatheterposition.Always comparetheanatomicalmap
tothepatient’sexpectedanatomy.Incorrectcatheter localizationmay leadtoincorrectclinical
conclusionorpatientinjury.
• Inthe eventthatroutingof thestimulationsignalthroughthemapping systemsoftwarefails,direct
stimulationmaybe required.Connectthestimulatorjumper cablestoany singlepair ofthedirect
stimulationports located aboveinput portsM, A,Bor ABL.The directstimulation portsabove input
portsM, A,andBconnectan externalstimulatorto channels61and62ofthe connectedbreakout
box.The directstimulation portsabove theABLSRUWFRQQHFWWRFKDQQHOVbDQGbRIWKHDEODWLRQ
catheter.
• Donotuse thesystemtoroute life-sustainingpacingsignals.Only diagnosticstimulation signals
(e.g.,induction) mayberouted throughthe system.Using thesystemto route life-sustainingpacing
mayresultin prolongedbradycardia.

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• Diagnosisand treatment ofcardiacarrhythmiasusing thesystemin conjunctionwithradiofrequency
(RF)ablationand othermedicaldevicesmay posea riskofadverseevents.Adverseevents (e.g.,
cardiac perforation,new arrhythmias,exacerbationofexistingarrhythmias) mayrequireadditional
intervention.
• Whena catheterlocalizationerroris encountered,usefluoroscopyorother visualizationtechniques
toverifycatheterlocation.Incorrectcatheterlocalizationmaylead toincorrect clinicalconclusionor
patientinjury.
• Donotconditionan IntellaMapOrionmappingcatheter whenit isin contactwith thepatient,either
externalor indwelling.Conditioningwhenin contactwith apatient mayleadtopatientinjury,
includingnew arrhythmiasorexacerbationof existingarrhythmias.
• Avoidincreasingpower ordurationofRF applicationbeyondyour standardofcaretotargetaspecific
changein localimpedance.Doingso mayresultindamagetoadjacentstructures,perforation caused
bysteampop,arrhythmias,and/orembolism.
7. CAUTIONS
7.1 General
• Usea frequentback-uproutinetoarchivecasesthatarenolongerneeded forimmediate
access.Thiswillreducethe riskofdataloss.
7.2 Duringthe Procedure
• To reducecatheterconfigurationmistakes,whenconnectingcatheterstothesystem,always
verifythe signalsbyreviewingthe signaldisplay andrecordingsystem toensurecorrect
configurationof catheter electrodesto displayedchannels.
• Importedgeometricalshellsshould onlybe usedas areference,forexampleto identify
anatomical features inadvanceofmapping.Use othervisualizationtools,suchas fluoroscopy or
echocardiographytoverify catheter location.
• Duringthe mappingprocedure,do notdisconnectthe localizationgeneratorfromthesignal
station.
• Manuallydisabling thelocalizationgeneratordisables allcathetervisualization andlocalization
capabilities,including impedancetracking.
• Thelocalizationgeneratormay interferewith implantedcardiacimplantable electronicdevices
(CIEDs).When mappinga patientwithsuchadevice,considerinterrogatingthedevicepre–
andpost-procedure.Thiswill identifyany changesinprogrammedparameterswhich could
thenbe correctedbeforetransferring thepatientfromthe procedureroom.Consultthe CIED
manufacturer instructionsforadditional information.
• Ifit becomesnecessary tointerrogateor program animplantedCIED whileusing thesystem,
temporarily turnoff thelocalizationgeneratorby usingthe on-screenbutton located onthe
annotatingandediting mapstoolbar.
• Thesoftwaremonitorslocationreferencebackpatch(back patch)andECG electrodeconnections
duringa study.If thecolor-codedpatchqualityindicators onthepatientalignment(user
interface) turnfromGREEN toRED(indicatinga poorquality connection),adjustor replace the
problempatch(es).
• TheECGcables(1 trunkcable,chest leadsset,andlimbleadsset) areprovidednon-sterile.They
canbereusedwith multiplepatients.Alwaysclean anddisinfectthe ECGcablesconsistentwith
facilityprotocolprior toreuse.

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• Donotenter patientidentifiabledata intoanyopen fieldsthatarenot dedicated topatient
information,oras part offilenamesbeingimportedintothe RhythmiaMappingSystem.
• PleaserefertotheInstructions forUseforthe compatiblecatheterpriortoenabling thedisplay
ofDirectSense™during RFenergyapplication.
• Confirmcatheter proximitytosheathusingtoolssuchasfluoroscopyorintracardiac echo.
• Sheathdetectionis tobeused withcompatibleAgilis,Zurpaz,and Direxsheaths.The
performanceofsheathdetectionwith othersheathshasnotbeen tested.Refertothe
InstructionsforUseforthecatheterforinformationon compatiblesheathsforthatcatheter
family.
8. POTENTIALADVERSEEVENTS
Anypotentialclinicalcomplicationsareinlargepartexpected tobe related totheaccessory diagnosticor
ablationcathetersthat areusedwiththe system,ratherthanthesystemitself.Inorderto identifypotential
adverseevents,the userisinstructedtoreadpertinent InstructionsforUsedocuments associated withthe
cathetersandablationgeneratorsthatwillbeemployed duringa mappingsession.
Aswith othermappingsystems,the RHYTHMIAHDxMappingSystemcanbeincidentallyassociated
withminor or majorclinicalcomplicationsintrinsictointracardiacprocedures.Potentialadverseevents
associated withtheuse of thesysteminclude,butarenotlimitedto,the following:
8.1 Arrhythmias
Dueto theprogrammedelectricalstimulationperformedduring EPdiagnosticprocedures
andcathetermanipulations,patientsundergoingEPproceduresareat potentialrisk of
arrhythmias.Thepatientmay experiencediscomfortfromthe rapidpacingand/ortheinitiation
ofan arrhythmia.While the systemhas noactiveroleinRFablation,a riskdoesexistthatthe
effectivenessofanRF ablationprocedurecouldbe suboptimalandcausethetargetedarrhythmia
toreoccur.
8.2 Misinterpretationof Data
Localization
Poor catheterlocalizationmayleadto clinicaldatamisinterpretationandthe potentialof resultant
patientinjury. To ensurecorrectclinicaldecisions,the physician mustusefluoroscopy,ultrasound,
pacemappingorother visualizationtechniquestoverify 3-Dmappingresultsandcatheter
position.
IncorrectForceMeasurements
Incorrect forcemeasurementdisplayedormisinterpretation oftheforcedisplayed mayleadthe
userto applymoreforcethandesiredduringmapping or ablating. Usermust heed toany user
errordisplayed.If UserOperatorappliesmoreforcethan desiredduring mappingorablating,
myocardial perforation,myocardialcontusion,or myocardialinjurycouldresult.
8.3 ElectricalHazards
Withany electricalsystemthereis apotentialriskofelectricalshocktotheuser,patient,and
servicerepresentative.

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9. HOWSUPPLIED
Thesoftwareis pre-loadedon Workstationsandcanonlybeupdatedthereafterby authorized
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Donot useifpackage isopenedor damaged.
Donot useiflabeling is incomplete orillegible.
10. MAJOROPERATINGMODES
10.1 StudyLogIn
Afterturning ontheWorkstation,theStartup screenappears (Figure 1).Use the3tabs onthe
Startupscreentoaccessthedesiredmode(“Live,”“Review,”or“Configure”).
ABC
D
Figure1. Startupscreen(sample)
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A. Live- Click toaccesstheLiveoperatingmode,screen,andfeatures.
B. Review- Click toaccesstheReviewoperatingmode,screen,andfeatures.
C. Configure-Click toaccesstheConfigureoperatingmode,screen,andfeatures.
D. SystemSettings- Clickthegear iconto accessthesystemsettingsscreen(accesstothis
modeis restrictedtoauthorizedusers).
10.2 Overview
Thereare3modesofsystemoperation,eachwithdistinct screens,features,and functions:
• LiveMode – Usetosetupthe study,andtocreate,display,review,and edit real-timemaps
anddata indifferent formats.This mode isaccessibleonlyduring anactivemappingstudy.

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• ReviewMode – Usetoreview,analyze,manipulate,and editmapsand studydata.This
modeis used afteran active mappingstudyand shouldnotbe usedduringastudy.
• ConfigureMode– Use toconfigure,add,or selectdifferent catheters,physicians,orstudy
templates.Thismodeis accessible beforeorafteramappingprocedure.
Inaddition,theSystem Settingsscreenisavailabletoenterorchangemajor systemsettings such
asthe dateand time,passwords,passwordandauthenticationpolicies,keyboardandmouse
settings,and display settings.Figure2outlinesthemajor systemmodes,screens,and functions.
Note: Accesstosystemsettingsis password-restrictedtoauthorizedusers.
REVIEW SYSTEM
SETTINGS
LIVE
Study Setup
Live Mapping
CONFIGURE
Configure
Ablation
Generator
File
Shares
Study
Templates
List
Physician
List
Catheter
Catalog
Figure2. Mapofmain screensand majorfunctions
10.3 LiveMode
From theStartupscreen(Figure1),clickonLive toaccessthe Live Modescreenandfunctions.
TheStartup screenenables theuserto enterinformationaboutthe patientandthe physician
performingthe case,and toselecta study template.A suspended studycanberesumed
byselecting it fromthe listofavailablestudiesusingthe LookupStudybutton.Thepatient
informationisableto belateraccessedandeditedusingtheEditPatient Infodialog boxlocated
inthe Studydropdownmenu.
&$87,21ɰ Donotenterpatientidentifiabledataintoany openfieldsthatarenotdedicated
topatientinformation,or aspartoffile namesbeingimportedintotheRhythmia Mapping
System.

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10.3.1 SetupScreen
TheLive Mode setupscreen(Figure3)isused topreparethesystemfora mapping
study.Forexample,it is usedtodefine,add,or configure catheters,electrodes,
stimulatorsignals,SiS connections,and graphs.
From anyLiveMode screen,clickonSetuptoaccess setupchoices.
Aiii iii & iv
B
C
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Figure3. SetupscreeninLiveMode(sample)
LiveMode setupscreenitemsinclude:
A. AnnotatingandEditingMapsTools
i. ImageImport button
ii. CatheterMotion Response settings
iii. DriftAdjustment check box
iv. CatheterStabilization check box
B. SignalStationStatus andConnections
C. CatheterListand ControlSettings
D. SweepGraph
E. PatientAlignment and ReferenceInterface
F. Signal(s)of SelectedCatheter(s)
A. AnnotatingandEditingMapsToolbar
ToolsforAnnotatingandEditing Mapsonthe Setupscreenaredescribedinthe
relevant sectionsidentifiedbelow:
i. ImageImportbutton – seeSection10.3.14,Image Import
ii.
CatheterMotionResponsesettings –seeSection10.3.9.4,TrackingRelated
Indicators
iii.
DriftAdjustment checkbox – seeSection10.3.9.4,TrackingRelatedIndicators
iv.
CatheterStabilizationcheckbox –see Section10.3.9.4TrackingRelatedIndicators

12
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B. SignalStationStatus andConnections
Thesystem employsahardwareauto-detect feature todisplay the statusof the
majorSiS connectionportstoidentify connectedperipheralsandtoidentify warning
conditionsshouldtheyexist.
TheSiS frontpanel is representedina diagramon theLiveModesetuptab.The
centercircleofidleportsisdark.Successfullyconnected ports areindicatedby asolid
colorcirclein thecenter ofeachsuchportalongwith text(eitheraboveorbelow the
port)listingthe peripheraldevicename(if detected).
Portswithan errorconditionhavea redwarningtriangle insteadofa solid colorcircle.
Anerrormessageisalsodisplayedin thetextareaassociatedwiththeproblemport.
Checkthe connectorstatusicons(Figure4) toverify which majorSiSinput cablesare
successfullyconnected (i.e.,M,A,B,ECG,ABL,and PATCH).
Figure4. SignalStation connectorstatusicons
C. CatheterListand ControlSettings
Cathetercontrolsettingsenable userstomanage catheters.Thelist of catheters is
displayedon the leftandthe unipolar andbipolarchannel setting(s)fortheselected
catheter(s)isdisplayedon theright(Figure 5).
Figure5. &DWKHWHUFRQWUROĬHOGVRQDVDPSOH/LYH0RGHVHWXSVFUHHQ
• DefiningCatheterCharacteristics
Catheterscanbe markedasamappingcatheter,ablationcatheterora
referencecatheter byclickingonthe appropriateicon.Users canalso select
thecolorsfordisplaying catheters in3D.
Selectthe gear icontoaccessadvanced catheter settingsrelatedtothe
catheterappearancein3D.

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13
• Filters
Userscan selectlow-passandhigh-passfiltersforunipolarandbipolar
channels,aswelltoggle onoroff linenoiserejection(60Hzor 50Hz).
• DefiningCatheterChannels
Byclicking on acathetername,that catheter’sunipolar andbipolarchannels
aredisplayed.
Theinterfacelets usersdeterminethephysicalconnectionof thecatheterto
thebreakoutbox.
Thefollowing settingsarealsoavailable:
• Changelabels fordisplayingchannels;and
• Addcustom bipolarpairsfordisplay,asneeded.
Ifdesired,users canalso de-activateaspecificelectrodefrombeingusedfor
mappingby unchecking itsactivebox.
Note: When thedirect-connectcableisused toconnectaCardioLab™
recordingsystemtothe system,dataacquiredon PortAChannels33-40is used
formapping purposeswithinthe softwarebutissupplanted byablationdata
inputfor theCardioLabrecordingsystem.
• Addingand Removing Catheters
Userscan addorremovecathetersasneeded.ClickAddCathetertoaccessthe
addcatheterscreenor clickonRemovetoremoveaselectedcatheter.
Note: Removing acatheterwillalsodeletealldatarecordedwith thatcatheter.
Afteradding acatheter,visually verifytheshapeand electrodespacing ofthe
catheterinthe3D catheter previewarea.
D. SweepGraph
SeeSweep Graphfordetails(Figure19).
E. PatientAlignment and ReferenceInterface
ThePatientAlignmentandReference UserInterface(Figure6)facilitates thefollowing
setupfunctions:
• Patientalignment tothemagnetic field-Priortobeginning thecase,auser
interface isprovidedtohelpwith patientalignmenttothemagnetic fieldand
selectionof additional settings.
• UnipolarReferencesignalselection- Theusercanselectandconfigurethe
unipolarreferencesignal.Theelectricalreferencesignal forunipolarsignals
canbe setby theusertobetakenfromeitherWilson’s Central terminal(WCT)
orany intracardiacelectrode.(Itisadvisable toselectan electrodethat isboth
stationaryanddistantfromthe mapped chamber.)
• Patchquality -TheRhythmia softwarebeginsmonitoringsurface electrode
signalsimmediatelyafterthe electrodesareapplied tothepatient and
continuestoactively monitorthemduring the study.Looseorimproperly-
connectedelectrodescandiminish signalquality.

14
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• Thepatchqualityindicators(Figure6)display thequalityfortheelectrodes
usedfor impedancetracking(Back Patch,RA, LA, LL,V1,V3,andV6).
Figure6. PatientAlignmentandReferenceUserInterface
• Thepatchqualityindicatorshave 4 separate severitylevels– GREEN,YELLOW,
ORANGE,andRED.The actualnumericvalueforeach patchindicatoris always
displayedwhen the valueis outsidetheGREENrange.Hover overthepatch
indicator toviewthe valuewhen the levelisin theGREENrange.
Note: The patchquality indicatorrangesarespecific tothe Signal Station
hardwareunit.Thenumericvaluefora patchshould onlybeused asan
indicationofrelative quality(i.e.,when the valueincreasesthequality worsens;
whenthe valuedecreases,thequalityimproves).
• Setupand referencesignal verification–Afterpatient alignmentiscomplete
andall surfaceelectrodesorECGpatchesareplacedandconnected,the
systemverifies thatthe connectionsignal and qualityareappropriate.
F. Signal(s)ofSelectedCatheter(s)
Thecathetersignal(s) sectionfacilitates thereviewofbipolaror unipolarsignalsfor
userselected catheters ofinterest.
10.3.2MultipleMonitorConfiguration
TheMonitor Configurationtoolallows theuserto setupprimaryandsecondary
windowsfor useduringa study.Theprimary windowshowsthemain software
interface,and asecondarywindow may optionallybe addedtoallow foradditional
informationtobe displayed inLiveand ReviewMode.A totalof fourmonitorsare
supportedby thesoftware withatleast onebeingconfiguredtodisplay theprimary
window.
Configurationoptionscanbe customizedbynavigatingtoSystemSettings,selecting
DisplaySettings,or alternatively,by using shortcutcommand“Ctrl+Alt+Delete”
(Figure7).Oncethe MultipleMonitorConfiguration Tool is open,selectEnterSetup

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whichallows the usertoconfiguretheprimaryandsecondarywindows basedon
preference.Figure8providesanexampleoftheprimaryandsecondarywindow
layouts.Eachconnected screenwill haveanassociatednumberat thetopof the
ConfigurationTool.ThenumbercorrespondswithScreen1,Screen2,etc.toinformthe
userwhich window theyareconfiguringtobeprimaryandsecondary.
Figure7. 0XOWLSOH0RQLWRU&RQĬJXUDWLRQ7RRO
Figure8. Primaryand Secondarylayoutoptions
Thesecondary window supports thefollowinguserinterfaceelements:
• LiveBeatGraph
• BeatReviewGraph
• Slow/FastGraph
• SweepGraph
• 3DView
• StudyLog
• BeatMetrics
• AutoTagParametersLivePane
• AutoTagParametersReviewPane
Usersareableto configure customsecondarywindow layoutscomprisedofthe
individualUI elements listedabove.Customlayoutsare savedaspartofthe study
templates.
TheMultiple MonitorfeaturesupportsHDMI,DVIand DisplayPortcables.Eachcable
andmonitor maybeconnectedprior toorduring astudy.Referto
RHYTHMIAHDx
MappingSystemHardwareInstructionsforUse
for further informationregardingthe
Workstation.

16
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10.3.3Preparing IntellaMapOrionFamily ofCathetersforUse
AnIntellaMap Orionmappingcathetermustbeconditionedbefore itisusedwith the
RHYTHMIAHDx Mapping System.
1. ConnectanIntellaMapOrion mappingcathetertoeither endofthe umbilical
cable.
2. Connecttheotherend oftheumbilicalcabletotheMinput connectionon the
frontpanelofthe SiS.
3. VerifythattheSiSisturned on.
4. Confirmthatthe localizationgeneratorandbackpatchareconnectedtothe
SiS.
5. Confirmthatthe backpatchisproperlypositionedonthepatient’sbackandis
withinthe localizationgenerator’smagneticfield.
6. Makecertainthatthecatheterisoutsidethepatient’sbodyandthelocalization
generator’smagneticfield.
7. CompletelysubmergeanIntellaMapOrion electrodearrayin sterilesaline.It is
essentialthatallelectrodesremainimmersedinthe salinesolutionthroughout
theconditioningprocess.
8. Waitforthebluecircleonthe SiSfrontpanelConditionbuttontobegin
flashingand thenpress thebuttontobegin theconditioningprocess.Thecircle
willremainilluminatedforapproximately10secondsandastatusmessagewill
beshown on theWorkstationscreen.
9. Conditioningprocesscompletionisindicated whentheblue circleis nolonger
illuminatedandaconfirmationmessageisshownon theWorkstationscreen.
Tore-condition anIntellaMapOrion mappingcatheter,performthefollowingsteps:
1. Makecertainthatthecatheterisoutside thepatient’s bodyandthe localization
generator’smagneticfield.
2. CompletelysubmergeanIntellaMapOrion electrodearrayin sterilesaline.It is
essentialthatallelectrodesremainimmersedinthe salinesolutionthroughout
theconditioningprocess.
3. Fromwithinthe software,selectConditioningWindowfromthestudy
dropdownmenuonthe Live Modesetupscreen.
4. Selectthe 29(55,'(35(ɭ&21',7,216 buttonontheconditioningwindow.
5. Verifythatpre-conditions aretobeoverridden byselectingtheConfirm
button.
6. Waitfortheblue circleon theSiSfrontpanelCondition buttontobegin
flashingthen pressthebuttontobeginthe conditioningprocess.Thecirclewill
remainilluminatedforapproximately10secondsandastatusmessagewill be
shownon the Workstationscreen.

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17
7. Conditioningprocess completionisindicatedwhentheblue circleis nolonger
illuminatedandaconfirmationmessageisshownon theWorkstation.
:$51,1*ɰ Do notconditionanIntellaMap Orionmappingcatheterwhen
itis in contactwith thepatient,either externalor indwelling.Conditioning
whenin contactwith a patientmayleadtopatientinjury,includingnew
arrhythmiasor exacerbation ofexistingarrhythmias.
10.3.4Map Tab
TheMapping Tab(Figure9) is themainscreenusedduring aprocedure.This screenis
usedto control mappingproceduresand view real-timedisplaysofactivestudies.
A
B
C
I
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J
E
G
D
E
G
D
E
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Figure9. Live ModeMapTab(sample)
/,9(02'(/,9(,7(06 ,1&/8'(ɰ
A. AnnotatingandEditing
MapsToolbar
B. BeatGraph
C. BeatMetricsPanel
D. 3DView
E. SweepGraph
F. BeatReview Graph
G. StudyLog
H. Slow/FastGraph
(Notshown inFigure9)
I. AutoTagParametersLivePane
J. AutoTagParametersReviewPane
TheMap tablayoutcanbeconfiguredbyselectingthe geariconnexttothetab.Allof
theuser interfaceelements inthelist above canbe added,removed,andreordered
topreference,with theexceptionofthe primary 3D View,and theAnnotatingand
EditingMaps Toolbar,which arealwayspresent.

18
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AnnotatingandEditingMapsToolbar
Theannotationandeditingtoolbaronthe Map tabmaybe usedtoconfigure
mappingsettings andtostart mapping(Figure10).
A B C D E
Figure10. &ORVHXSYLHZRIWDEVSHFLĬFWRROVLQ/LYH0RGH
Livescreentoolsinclude:
A. MappingCatheterSelection
B. NewMap Button
C. ActiveMap Selection andProjection Distance
D. Record MapButton(orstart mapping)
E. GeometryDataAcquisitionSettings (includingbeatand respirationgating)
BeatMetricsPanel
Usethe BeatMetricsPaneltoreviewand edit thebeatacceptancecriteriausedin
continuousmappingandmanual mapping modes.Click onShowBeat Metricsto
displayall metrics.Beatacceptancecriteriainclude:
• CycleLength(CL) -Acceptsbeatifthecyclelength iswithinthespecified
acceptancerange.
•3URSDJDWLRQ5HIHUHQFHƒ5$FFHSWVEHDWLIWKHWLPHGLIIHUHQFHEHWZHHQ
timingand propagationreferenceeventsarewithin the specifiedacceptance
range.
• Respiration (RSP)-Acceptsbeat ifrespirationwaveform iswithinthe specified
acceptancerange.
MappingCatheterMovement (M) -Acceptsbeatif mappingcathetermotionwithin
mappingwindow is lessthan aspecifiedamount.
• ElectrogramStabilitycomparingtolastbeat(S)-Acceptsbeat ifallmapping
catheterEGMsmatchpreviousbeattoaspecific levelaccordingtoa
correlation-basedmetric.
• Tracking Quality(TR)-Acceptsbeatif mappingcatheterpositionaccuracyis
withinthe specified acceptancerange.
• ECGMorphology(ECG)-Acceptsbeatif QRSmatchestarget ECG morphology
offavoritebeattoaspecific levelaccordingtoacorrelation-basedmetric.

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19
Thevalues ofCycleLength(CL)andRespiration(Resp) metricsarealsoplottedover
timeon a graph(Figure11).The greenareaindicates theacceptancethresholdand can
bemanually adjustedincaseofdriftover time.
Figure11. CycleLength(CL) andRespiration (Resp)display
Proper beatmetricssettingisnecessaryforthecreationofhighquality
electroanatomicalmaps.Inappropriate beatmetrics maycausetheacceptanceof
undesiredbeatsor the rejectionof desiredbeats.
10.3.4.1 SystemReferenceElectrode
Thesystem referenceelectrodeis required forproper operationofthe
impedancelocationtechnology.Thereferenceisastationary intracardiac
electrode(e.g.,a coronarysinuselectrode)selectedby theuserandconnected
toPin 1(GREEN)on the breakout boxthat isconnected toinputportA.
Note: Do notuse the systemreferenceelectrodeforstimulation.Stimulation
throughthesystemreferenceelectrodecouldcauseinaccurate localizationof
catheters.
10.3.4.2SystemStatusMessages
Thesystem messagesand LocalizationGeneratorstatusiconappearson all
LiveMode screensin the Annotationand EditingMapsToolbar.
Whenthe localizationgeneratorisenabled,theGREENON iconappears
(Figure12).The ORANGEOfficonanda messagethattrackinghas been
disabledaredisplayedwhen the localizationgeneratorisdisabled (Figure12).
Figure12. Statusindicatorsshowinglocalizationgeneratorenabled(left)and
disabled(right)
LocalizationGeneratorDisableor Enable Feature
Insome instances,itmaybe desirabletomanuallydisable thelocalization
generator(e.g.,a patientwitha cardiacimplantableelectronicdevice(CIED)).
Thelocalizationgeneratoriscontrolled(enabled ordisabled)by a single
buttonpresentin toolbarson theSetup,Map,andAlignmentlivemapping
screens.
&$87,21ɰ Manuallydisabling thelocalizationgenerator disablesallcatheter
visualizationand localizationcapabilities,includingimpedancetracking.

20
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Anerrormessagewillappearwhenthe localizationgeneratorisdisabled.
Tore-enablecatheter visualization,enablethelocalizationgeneratorby
selectingthe LocalizationGeneratorSoftwarebutton.
Thedefault settingforthelocalizationgeneratorison.To disablethe
localizationgenerator fromany livemappingscreen,clickontheGREEN ON
button(Figure12).Thisdisablesthe localizationgenerator.The buttonturns
ORANGEand changes toOff when clicked.In addition,a messageappears
indicatingthattrackinghasbeen disabled.
Ifcathetervisualizationdisappearsunexpectedly,checkthesoftware
message(s)toseeif thelocalizationgenerator wasunintentionally disabled.
Tore-enablethelocalizationgenerator,clickthe Off button(Figure12).
Initializationtakesapproximately5seconds,afterwhichthe ONbuttonturns
GREENand the warningmessagedisappears.
Donot beginastudy if anyofthe systemmessagesorstatusindicators
indicates aproblem.Therearethreelevels ofsystemmessages(Table1).Refer
tothe softwaretroubleshootingguide(Section 11,Softwaretroubleshooting
guide)or contactBoston ScientificSupportforfurther assistance.
Table1. SystemMessages
1
Block Requireimmediate useraction.Until theconditionis resolved,Systemoperation
orthe acquisitionofspecific signals,suchas force,DirectSense,or mappingdata,
willbe blocked.
2
Warn Recommendeduser action(s)foroptimal systemperformance.Systemoperation
continues,but themessage persistsuntil theconditionis resolved.Some warning
messagesmayblock acquisitionofspecific data,suchas force,DirectSense,or
mappingdata.
3
Inform Displayimportant factsaboutthe currentstateofsystemoperation.Useraction is
recommended,but notrequired.
Note: Move thecursorover an activemessageicontoviewtroubleshooting
tipsfor theconditioncausingthatmessage.Forfurther informationrefertothe
software troubleshootingguide(Section11,Software troubleshootingguide).
10.3.4.3Stimulation
Cardiactissuestimulation maybeneeded duringamappingprocedure.Two
stimulationchannels canbe connectedtothesystemusingportsonthe SiS
frontpanel.
TheRhythmia softwareprovidesan interfaceforroutinginputstimulation
signalsto specificintracardiacelectrodes.Stimulatorcontrolfieldsallow users
toselect theintracardiacbipolar channelstobe mappedtostimulatorinputs
P1and/or P2.Forconvenience,the usercanright-clickonabipolar tracein
theSweep orBeatGraphand setthatchanneltobe routedtoone of thetwo
inputsfor stimulation.
Onceconfigured,upto2 pairsofchannels canberoutedforsimultaneous
stimulationby clickingonthe desiredchannels.