Gynesonics SONATA2-110 User manual

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SonataTranscervical
FibroidAblationSystem
2.22797
REF‐009LS03818‐009Rev01October2020
Operator’sManual
withTechnicalAppendix

SONATA2‐110/‐220with 
RadiofrequencyHandpieceRFA‐002,RFAHandpiece
CableACCY‐008,andSoftwareSW‐002

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LS03818‐009Rev01,October2020 
Notice
Sonata®SystemOperator’sManual
©2020Gynesonics,Inc.AllRightsReserved
TheSonataSystemandaccessories,includingtheassociatedhardwareandsoftware,isownedby
Gynesonics®,Inc.andisprotectedbytheUnitedStatescopyrightlawsandinternationaltreatyprovisions.
Thismanualmaynotbecopiedinwholeorinpartorreproducedwithoutthewrittenpermissionof
Gynesonics,Inc.Copyingincludestranslationintoanotherlanguageandtransferringintoothermedia.
Permittedcopiesmustcarrythesameproprietaryandcopyrightnoticesaswereaffixedtotheoriginalunder
thelaw.Pleasenotethatwhileeveryefforthasbeenmadetoensurethattheinformationinthisdocumentis
accurate,theinstructions,photos,figures,illustrations,tables,specifications,andschematicscontained
hereinaresubjecttochangewithoutnotice.Ifyouhaveanyquestionsregardingtheappropriateuseofthis
deviceorconcerninganysafetyoroperatinginstructionsdescribedinthismanual,pleasecontactyourlocal
GynesonicsRepresentativeortheservicedepartmentofGynesonicsat:
Gynesonics,Inc.
600ChesapeakeDrive
RedwoodCity,CA94063USA
Telephone:+1‐650‐216‐3860
Fax:+1‐650‐299‐1566
www.gynesonics.com
[email protected]
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TrademarkandPatentInformation
Gynesonics,Sonata,andthelogoaretrademarksandregisteredtrademarksofGynesonics,Inc.Allother
trademarksarepropertiesoftheirrespectiveowners.GynesonicsproductsarecoveredbyUSandforeign
patents.
Seewww.Gynesonics.com/patentsforlistofapplicablepatents.

AboutthisOperator’sManual
ThisOperator’sManualcoverstheSonataSystemandallaccessoriesandmaterialsneededfortheprocedure.
ThisOperator’sManualisprovidedbyGynesonicsasacomponentintheSonataSystemandshouldbekept
ontheSystemCartforreferenceatalltimes.ContactGynesonicsforadditionalcopiesofthismanual,any
additionalquestionsorsupportrequiredfortrainingandservice,includinginstallation,andmaintenance.For
detailedtechnicalinformation,maintenanceandserviceinformation,refertotheTechnicalManualin
AppendixB.
ManualoriginallyissuedinEnglish.
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LS03818‐009Rev01,October2020 
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Thispageleftblankintentionally.
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TableofContents
REF‐009LS03818‐009RevTBDOctober2020 i
TableofContents
SymbolsGlossary......................................................................................................v 
GlossaryofTerms,Acronyms,andDefinitions........................................................xiv 
Chapter1  GeneralInformation................................................................................1 
DeviceDescription.................................................................................................................................1
IntendedUse..........................................................................................................................................1
Contraindications...................................................................................................................................1
PatientSelection....................................................................................................................................2
PatientCounseling,PotentialPostoperativeEvents,andRisks............................................................3
InitialInstallationandSetup..................................................................................................................3
RoomRequirements..............................................................................................................................4
ManufacturerandService.....................................................................................................................5
IntendedOperatorsandSupportPersonnel.........................................................................................5
GeneralWarnings..................................................................................................................................6
Cautions...............................................................................................................................................12
Chapter2  SonataSystemOverview.......................................................................15 
SonataSystemComponents................................................................................................................15
SMARTTablet......................................................................................................................................17
GraphicalGuidanceSoftware(GGS)....................................................................................................21
Radiofrequency(RF)Generator...........................................................................................................23
SystemCart..........................................................................................................................................25
DispersiveElectrodes...........................................................................................................................25
IntrauterineUltrasound(IUUS)Probe.................................................................................................26