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.