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


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]

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

TableofContents
REF‐009LS03818‐009RevTBDOctober2020 ii
RadiofrequencyAblation(RFA)Handpiece.........................................................................................27
PneumaticFootswitch.....................................................................................................................3031
SystemPowerCord.............................................................................................................................31
SafetyInformation..............................................................................................................................31
Chapter3  PreparationforTreatment.....................................................................33 
PositiontheSystemCartandLockWheels.........................................................................................33
SetUptheSonataSystem...................................................................................................................34
RequiredProcedureSupplies.............................................................Error!Bookmarknotdefined.38
UnpackagetheSonataProcedureKit..............................................................................................3738
PositionPatient...............................................................................................................................3941
ApplyDispersiveElectrodesandConnectbothDispersiveElectrodeCablestoRFGenerator......4042
PreparetheSonataSystem.............................................................................................................4446
Chapter4  SonataTranscervicalFibroidAblation(TFA)Procedure......................5052 
InspecttheSonataTreatmentDevice.............................................................................................5052
InsertSonataTreatmentDevice......................................................................................................5254
IdentifyPertinentAnatomy.............................................................................................................5355
TargetaFibroid...............................................................................................................................5456

TableofContents
REF‐009LS03818‐009RevTBDOctober2020 iii
PositionIntroducerTiptotheIntroducerPlanLine........................................................................6163
AlignSMARTGuidetoIntroducerTipandConfirm.........................................................................6466
PerformFirstSafetyRotation..........................................................................................................6567
PositionNeedleElectrodestoNeedleElectrodePlanLines............................................................6769
PerformFinalSafetyRotation.........................................................................................................7072
ActivateRFAblation,HoldDeviceSteady,andMonitorRFGeneratorStatus................................7274
PerformMultipleAblations,PerformMultipleTreatments,orRetractSonataTreatment
Device.............................................................................................................................................
7678
Chapter5  Post‐ProcedureInstructions...............................................................8183 
DisconnectandRemoveDispersiveElectrodes...............................................................................8183
DisconnectSonataTreatmentDeviceComponents........................................................................8284
ShutDownSystem...........................................................................................................................8385
DisassembleSonataTreatmentDevice–SeparateRFAHandpiecefromtheIUUSProbe.............8486
IUUSProbePoint‐of‐UsePre‐Cleaning............................................................................................8587
CleantheSystemEquipmentwithLowAlcoholDisinfectant.........................................................8789
StoreSystem....................................................................................................................................8890
Chapter6  SoftwareFeatures..............................................................................8991 
GraphicalGuidanceSoftware(GGS)Overview................................................................................8991
PatientData........................................................................................Error!Bookmarknotdefined.93

TableofContents
REF‐009LS03818‐009RevTBDOctober2020 iv
Measurements................................................................................................................................9195
Annotation......................................................................................................................................9296
Preferences.....................................................................................................................................9296
HideSMARTGuide..........................................................................................................................9599
ShowScale.....................................................................................................................................96100
PatientDataandImageManagement..........................................................................................97101
Chapter7  Troubleshooting.............................................................................105109 
Symptoms,Problems,andPotentialSolutions...........................................................................106110
SystemSoftwareMessages.........................................................................................................109113
AppendixA  ClinicalTrialResults.....................................................................115119 
AppendixB  TechnicalManual.........................................................................133137 
IndexofTerms................................................................................................164168 


SymbolsGlossary
REF‐009LS03818‐009RevTBDOctober2020 v
SymbolsGlossary
ThefollowingtablesshowthesafetysymbolsthatareusedontheSonataSystemandthroughoutthis
manual.

SYMBOLSYMBOLTITLEEXPLANATORYTEXTSTANDARD
REFERENCESTANDARDTITLE

ManufacturerIndicatesthemedical
devicemanufacturer.
ISO15223‐1
#5.1.1
Medicaldevices—Symbolsto
beusedwithmedicaldevice
labels,labeling,and
informationtobesupplied.
EN980#5.12Symbolsforuseinthelabeling
ofmedicaldevices.
ISO7000‐
3082
Graphicalsymbolsforuseon
equipment.

Dateof
Manufacture
Indicatesthedate
whenthemedical
devicewas
manufactured.
ISO15223‐1
#5.1.3
Medicaldevices–Symbolsto
beusedwithmedicaldevice
labels,labeling,and
informationtobesupplied.
EN980#5.6Symbolsforuseinthelabeling
ofmedicaldevices.
ISO7000‐2497Graphicalsymbolsforuseon
equipment.
Catalognumber
Indicatesthe
manufacturer’s
catalognumberso
thatthemedical
devicecanbe
identified.
ISO15223‐1
#5.1.6
Medicaldevices–Symbolsto
beusedwithmedicaldevice
labels,labeling,and
informationtobesupplied.
EN980#5.10Symbolsforuseinthelabeling
ofmedicaldevices.
ISO7000‐2493Graphicalsymbolsforuseon
equipment.

Serialnumber
Indicatesthe
manufacturer’sserial
numbersothata
specificmedical
devicecanbe
identified.
ISO15223‐1
#5.1.7
Medicaldevices–Symbolsto
beusedwithmedicaldevice
labels,labeling,and
informationtobesupplied.
EN980#5.5Symbolsforuseinthelabeling
ofmedicaldevices.
ISO7000‐2498Graphicalsymbolsforuseon
equipment.
BatchCode
Indicatesthe
manufacturer’sbatch
codesothatthebatch
orlotcanbe
identified.
ISO15223‐1
#5.1.5
Medicaldevices–Symbolsto
beusedwithmedicaldevice
labels,labeling,and
informationtobesupplied.
EN980#5.4Symbolsforuseinthelabeling
ofmedicaldevices.
ISO7000‐2492Graphicalsymbolsforuseon
equipment.


SymbolsGlossary
REF‐009LS03818‐009RevTBDOctober2020 vi
SYMBOLSYMBOLTITLEEXPLANATORY
TEXT
STANDARD
REFERENCESTANDARDTITLE


Usebydate
Indicatesthedate
afterwhichthe
medicaldeviceisnot
tobeused.
ISO15223‐1
#5.1.4
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
EN980#5.3
Symbolsforuseinthe
labelingofmedical
devices.
ISO7000‐2607Graphicalsymbolsforuse
onequipment.

Authorized
representative
inthe
European
Community
Indicatesthe
authorized
representativeinthe
European
Community.
ISO15223‐1
#5.1.2
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
EN980#5.13
Symbolsforuseinthe
labelingofmedical
devices.

Follow
instructionsfor
use
Refertoinstruction
manual/booklet.
IEC60601‐1
TableD.2,
Symbol10
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
ISO7010‐
M002
Graphicalsymbols–Safety
colorsandsafetysigns–
Registeredsafetysigns.

Sterilizedusing
irradiation
Indicatesamedical
devicethathasbeen
sterilizedusing
irradiation.
ISO15223‐1
#5.2.4
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
EN980#5.8.3
Symbolsforuseinthe
labelingofmedical
devices.
ISO7000‐2502Graphicalsymbolsforuse
onequipment.

Sterilizedusing
ethyleneoxide
Indicatesamedical
devicethathasbeen
sterilizedusing
ethyleneoxide.
ISO15223‐1
#5.2.3
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
EN980#5.8.2
Symbolsforuseinthe
labelingofmedical
devices.
ISO7000‐2501Graphicalsymbolsforuse
onequipment.

SymbolsGlossary
REF‐009LS03818‐009RevTBDOctober2020 vii
SYMBOLSYMBOLTITLEEXPLANATORY
TEXT
STANDARD
REFERENCESTANDARDTITLE

Non‐sterile
Indicatesamedical
devicethathasnot
beensubjectedtoa
sterilizationprocess.
ISO15223‐1
5.2.7
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
EN980#5.23
Symbolsforuseinthe
labelingofmedical
devices.
ISO7000‐2609Graphicalsymbolsforuse
onequipment.

DONOTre‐use
Indicatesamedical
devicethatis
intendedforoneuse
orforuseonasingle
patientduringa
singleprocedure.
ISO15223‐1
#5.4.2
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
EN980#5.2
Symbolsforuseinthe
labelingofmedical
devices.
ISO7000‐1051Graphicalsymbolsforuse
onequipment.

DONOT
resterilize
Indicatesamedical
devicethatisnotto
beresterilized.
ISO15223‐1
#5.2.6
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
EN980#5.22
Symbolsforuseinthe
labelingofmedical
devices.
ISO7000‐2608Graphicalsymbolsforuse
onequipment.

DONOTuseif
packageis
damaged
Indicatesamedical
devicethatshould
notbeusedifthe
packagehasbeen
damagedoropened.
ISO15223‐1
#5.2.8
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
EN980#6.3
Symbolsforuseinthe
labelingofmedical
devices.
ISO7000‐2606Graphicalsymbolsforuse
onequipment.

Fuse
Toidentifyfuseboxes
ortheirlocation.
Accompaniedbythe
typeandfullratingof
thefuse.
IECTR
60878#5016
Graphicalsymbolsfor
electricalequipmentin
medicalpractice.
IEC60417
#5016
Graphicalsymbolsforuse
onequipment.

SymbolsGlossary
REF‐009LS03818‐009RevTBDOctober2020 viii
SYMBOLSYMBOLTITLEEXPLANATORY
TEXT
STANDARD
REFERENCESTANDARDTITLE

TypeBF
appliedpart
ToidentifyaTypeBF
appliedpart
complyingwithIEC
60601‐1.TypeBF
referstoclassification
ofthenatureof
patientcontactand
degreeofpatient
protectionfromrisk
ofelectricalshock.
IEC60601‐1
TableD.1.
Symbol20
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
IEC60417
#5333
GraphicalSymbolsforUse
onEquipment.

HighFrequency
(HF)isolated
patientcircuit
Indicatesconnection
toahighfrequency
(HF)isolatedpatient
circuit.
IEC60601‐2‐2
#201.7.2.10
Medicalelectrical
equipment–Part2‐2:
Particularrequirements
forthebasicsafetyand
essentialperformanceof
highfrequencysurgical
equipmentandhigh
frequencysurgical
accessories.

Linearor
curvedarray
probe
Toidentifythe
controlorthe
indicatortoactivatea
lineararrayorcurved
arrayprobeforthe
electronicgeneration
ofasoundfieldand
toidentifythe
corresponding
connector.
TR60878
#5710
GraphicalSymbolsfor
electricalequipmentin
medicalpractice.

Non‐ionizing
electro‐
magnetic
radiation
Toindicategenerally
elevated,potentially
hazardous,levelsof
nonionizingradiation,
ortoindicate
equipmentor
systems,e.g.,inthe
medicalelectrical
areathatincludeRF
transmittersorthat
intentionallyapplyRF
electromagnetic
energyfordiagnosis
orablation.
IEC60878
#5140
GraphicalSymbolsfor
electricalequipmentin
medicalpractice.
IEC60417
#5140
GraphicalSymbolsforUse
onEquipment.

Dangerous
voltage
Toindicatehazards
arisingfrom
dangerousvoltages.
IEC60601‐1
TableD.1
symbol24
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
IEC60417
#5036
GraphicalSymbolsforUse
onEquipment.

SymbolsGlossary
REF‐009LS03818‐009RevTBDOctober2020 ix
SYMBOLSYMBOLTITLEEXPLANATORY
TEXT
STANDARD
REFERENCESTANDARDTITLE

Equipo‐
tentiality
Toidentifythe
terminalswhich,
whenconnected
together,bringthe
variouspartsof
equipmentorofa
systemtothesame
potential,not
necessarilybeingthe
earth(ground)
potential,e.g.,for
localbonding.
IEC60601‐1
TableD.1
symbol8
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
IEC60417
#5021
GraphicalSymbolsforUse
onEquipment.
IPX7 
Degreeof
Ingress
Protection
Providedby
Enclosure
Protectedagainstthe
effectsoftemporary
immersioninwater.
IEC60601‐1
TableD.3,
Symbol2
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
IEC60529
section6
DegreesofProtection
ProvidedbyEnclosures.
IPX6 
Degreeof
Ingress
Protection
Providedby
Enclosure
Protectedagainst
powerfulwaterjets
IEC60601‐1
TableD.3,
Symbol2
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
IEC60529
section6
DegreesofProtection
ProvidedbyEnclosures.
“ON”(power)
Toindicate
connectiontothe
mains,atleastfor
mainsswitchesor
theirpositions,and
allthosecaseswhere
safetyisinvolved.
IEC60601‐1
TableD.1
symbol12
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
IEC60878
#5007
GraphicalSymbolsfor
electricalequipmentin
medicalpractice.
“OFF”(power)
Toindicate
disconnectionfrom
themains,atleastfor
mainsswitchesor
theirpositions,and
allthosecaseswhere
safetyisinvolved.
IEC60601‐1
TableD.1
symbol13
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
IEC60878
#5008
GraphicalSymbolsfor
electricalequipmentin
medicalpractice.
Stand‐by
Toidentifytheswitch
orswitchpositionby
meansofwhichpart
oftheequipmentis
switchedoninorder
tobringitintothe
stand‐bycondition.
IEC60601‐1
TableD.1
symbol29
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
IECTR60878
#5009
GraphicalSymbolsfor
electricalequipmentin
medicalpractice.

SymbolsGlossary
REF‐009LS03818‐009RevTBDOctober2020 x
SYMBOLSYMBOLTITLEEXPLANATORY
TEXT
STANDARD
REFERENCESTANDARDTITLE

Caution
Toindicatethat
cautionisnecessary
whenoperatingthe
deviceorcontrol
closetowherethe
symbolisplaced,or
toindicatethatthe
currentsituation
needsoperator
awarenessor
operatoractionin
ordertoavoid
undesirable
consequences.
IEC60601‐1
TableD.1
symbol10
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
ISO7000‐
0434A
Graphicalsymbolsforuse
onequipment

General
warningsign
Tosignifyageneral
warning.
IEC60601‐1
TableD.2
symbol2
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
ISO7010
W001
Graphicalsymbols–Safety
coloursandsafetysigns–
Registeredsafetysigns.

Alarmwarning
sign
Displayedonthe
ultrasounddisplay
screentosignifya
potentialoractual
hazardoussituation
existsforphysician
awarenessor
responseisrequired.
IEC60601‐1‐
8:2007+A11:201
7AnnexCNo.1
Reference
60417‐5307
Generalrequirementsfor
basicsafetyandessential
performance—Collateral
Standard:General
requirements,testsand
guidanceforalarmsystems
inmedicalelectrical
equipmentandmedical
electricalsystems(IEC
60601‐1‐8:2006)

Fragile,handle
withcare
Indicatesamedical
devicethatcanbe
brokenordamagedif
nothandledcarefully.
ISO15223‐1
#5.3.1
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
ISO7000‐0621Graphicalsymbolsforuse
onequipment.

DONOTstack
Toindicatethatthe
itemshallnotbe
verticallystacked,
eitherbecauseofthe
natureofthe
transportpackaging
orbecauseofthe
natureoftheitems
themselves.
ISO7000‐2402Graphicalsymbolsforuse
onequipment.

SymbolsGlossary
REF‐009LS03818‐009RevTBDOctober2020 xi
SYMBOLSYMBOLTITLEEXPLANATORY
TEXT
STANDARD
REFERENCESTANDARDTITLE

Keepdry
Indicatesamedical
devicethatneedsto
beprotectedfrom
moisture.
ISO15223‐1
#5.3.4
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
ISO7000‐2626Graphicalsymbolsforuse
onequipment.
EN980#5.21
Symbolsforuseinthe
labelingofmedical
devices.

Thissideup
Toindicatecorrect
uprightpositionof
thetransport
package.
ISO7000‐0623Graphicalsymbolsforuse
onequipment.

Temperature
limit
Indicatesthe
temperaturelimitsto
whichthemedical
devicecanbesafely
exposed.
ISO15223‐1
#5.3.7
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
ISO7000‐0632Graphicalsymbolsforuse
onequipment.
EN980
#5.17.3
Symbolsforuseinthe
labelingofmedical
devices.

Humidity
limitation
Indicatestherangeof
humiditytowhich
themedicaldevice
canbesafely
exposed.
ISO15223‐1
#5.3.8
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
ISO7000‐2620Graphicalsymbolsforuse
onequipment.
Atmospheric
pressure
limitation
Indicatestherangeof
atmosphericpressure
towhichthemedical
devicecanbesafely
exposed.
ISO15223‐1
#5.3.9
Medicaldevices–Symbols
tobeusedwithmedical
devicelabels,labeling,and
informationtobe
supplied.
ISO7000‐2621Graphicalsymbolsforuse
onequipment.

Prescription
Only
Requiresa
prescriptioninthe
UnitedStates.
21CFR
801.15(c)(1)(i)
F
Labeling‐Medicaldevices;
prominenceofrequired
labelstatements.
21CFR
801.109
Labeling‐Prescription
devices.

SymbolsGlossary
REF‐009LS03818‐009RevTBDOctober2020 xii
SYMBOLSYMBOLTITLEEXPLANATORY
TEXT
STANDARD
REFERENCESTANDARDTITLE

Alternating
current
Toindicateonthe
ratingplatethatthe
equipmentissuitable
foralternating
currentonly;to
identifyrelevant
terminals.
IEC60601‐1
TableD.1.
Symbol1
Medicalelectrical
equipment—Part1:
Generalrequirementsfor
basicsafetyandessential
performance.
ISO7000‐5032Graphicalsymbolsforuse
onequipment.

Mass;weight
FortheSonata
System,thisindicates
thetotalweightof
thefullyloaded
SystemCartincluding
safeworkingload.
ISO7000‐
1321B
Graphicalsymbolsforuse
onequipment.

Autoclave
symbol
Sterilizableinasteam
sterilizer(autoclave)
attemperature
specified
ISO7000‐2868Graphicalsymbolsforuse
onequipment.


SymbolsGlossary
REF‐009LS03818‐009RevTBDOctober2020 xiii
2797

SymbolsNotfromStandards

SYMBOLSYMBOLTITLEEXPLANATORYTEXTREFERENCETITLE

CEmarkingSignifiesEuropeantechnical
conformity.
Directive
93/42/EEC
AnnexXII
MedicalDevice
Directive

TUVMark
Indicatesthattheproduct
wastestedandmetthe
certificationrequirements
forelectrical,and/or
mechanicalproducts.
N/AN/A

Recycle:
electronic
equipment
DONOTdisposeofelectronic
equipmentinnormaltrash.
Directive
2012/19/EU
AnnexIX
MarkingofElectrical
andElectronic
Equipmentin
accordancewith
Article15(2)of
Directive
2012/19/EU

Sterilizedusing
Hydrogen
Peroxide(e.g.,
STERRAD)
Indicatesamedicaldevice
thathasbeensterilizedusing
HydrogenPeroxide(e.g.,
STERRAD)
N/AN/A

Sterilizedusing
plasma(e.g.,
STERRAD)
Indicatesamedicaldevice
thathasbeensterilizedusing
plasma(e.g.,STERRAD)
N/AN/A

MedicalDevice Indicatesthatthedeviceisa
MedicalDevice
MedTech
Europe
Guidance
May2019
UseofSymbolsto
IndicateCompliance
withtheMDR

Sterilizedusing
vaporized
hydrogen
peroxide
Indicatesamedicaldevice
thathasbeensterilizedusing
vaporizedhydrogenperoxide
MedTech
Europe
Guidance
May2019
UseofSymbolsto
IndicateCompliance
withtheMDR

GlossaryofTerms,Acronyms,andDefinitions
REF‐009LS03818‐009RevTBDOctober2020 xiv
GlossaryofTerms,Acronyms,andDefinitions

TERMDEFINITION
Ablation(RFAblation)Theapplicationofradiofrequency(RF)energytotissue.
AblationZone
AgraphicalelementoftheSMARTGuide(redinnerellipse)thatisatwo‐
dimensionalrepresentationoftheaverageregionoftissueablationfortheselected
ablationsize.
AdministratorThepersonresponsibleformanaginguserprofilesandimagefileswithintheSonata
System(GGS)software.
AIUMAmericanInstituteofUltrasoundinMedicine
ArticulationLeverTheself‐lockingcontrolarmusedtopivottheArticulatingTipontheIUUSProbe.
ArticulatingTipThethree‐positionarticulatingImagingSurfaceoftheIUUSProbe,controlledbythe
ArticulationLever.
Button
Asoftwarecommandwithwordsinsidearectangularshapethatprovidesoptions
fortheuser.AlsousedtodescribethehardwarebuttonsforRFON/OFF,SMART
TabletPowerON,andConfirmButton.
CleaningPhysicalremovalofsoilandcontaminantstotheextentnecessaryforfurther
processing.
ConfirmButton
Duringthetargetingsteps,theConfirmButton(locatedonthetopsideoftheRFA
Handpiece)isusedbytheOperatortoverifywhenastepinthesequencehasbeen
completed.
DEAbbreviationforDispersiveElectrode.
DisinfectionThedestructionofpathogensandothermicroorganismsbyphysicalorchemical
means.
DispersiveElectrodes
Two(2)adhesivepads,eachappliedtoananteriorthighofthepatient,toreturn
energyfromthepatientbacktotheRFGenerator,completinganelectrical
connection.
EMCElectromagneticCompatibility
EMIElectromagneticInterference
EnzymaticDetergentAsolutionformedicaldevicecleaningdesignedforremovalofbiologicalsoilsuchas
blood,tissue,andbiofilms.
FIGO
TheInternationalFederationofGynecologyandObstetrics(Fédération
InternationaledeGynécologieetd’Obstétrique)thathasestablishedafibroid
subclassificationsystem.
GraphicalGuidance
Software(GGS)
UserinterfacesoftwareinstalledontheSMARTTablettoallowtheoperationofthe
TreatmentDevice.
GynesonicsSonataSystemmanufacturer
IconAsoftwaregraphicontheUltrasoundDisplayScreenthatprovidesaccessto
additionalfunctionality,suchasthePreferencesicon.
ImagingSurfaceThetransducersurfaceatthetipoftheIntrauterineUltrasoundProbe.
IntrauterineUltrasound
(IUUS)Probe
Areusableimagingdevicethatconnectstothesingle‐useRFAHandpiecetocreate
theSonataTreatmentDevice.TheIUUSProbeimagestheuterusfromwithinthe
endometrialcavity.
Introducer
AsharpenedcannuladeployedfromtheshaftoftheRFAHandpiece.TheIntroducer
enablespenetrationintodensefibroidtissueasaninitialstageofdeployingthe
NeedleElectrodes.

GlossaryofTerms,Acronyms,andDefinitions
REF‐009LS03818‐009RevTBDOctober2020 xv
TERMDEFINITION
IntroducerGuideAgraphicalelementoftheSMARTGuide,representedbyabluedashedline,that
identifiestheprojectedpathoftheIntroducerwhenadvanced.
IntroducerPlanLineAgraphicalelementoftheSMARTGuide,representedbyayelloworredline,used
toguidetheOperatorwhenadvancingtheIntroducerTip.
IntroducerSlider(s)AslidingcontrolontheRFAHandpiecethatallowstheOperatortoadvanceor
retracttheIntroducer.
IntroducerTipThesharppointoftheIntroducer.
IntroducerTipAlignment
Guide
AgraphicalelementoftheSMARTGuide,representedbyayellowdiamondwith
arrows,thatisalignedtotheIntroducerTip.
IntroducerTipMarker
AgraphicalelementoftheSMARTGuiderepresentedbyRedDiamondafterthe
IntroducerTipAlignmentGuideisalignedtotheIntroducerTipandtheConfirm
Buttonispressed.
IntroducerTrackerAgraphicalelementoftheSMARTGuide,representedbyanarrowhead,thatmoves
withtheIntroducertipduringadvancement.
NeedleElectrode(s)Seven(7)nickel‐titanium(nitinol)needlesthatdeployradiallyfromtheIntroducer
TiptodistributeRFenergywithinavolumeoftissue.
NeedleElectrodePlan
Lines
GraphicalelementsoftheSMARTGuide,representedbythreeyelloworredlines
usedtoguidetheOperatorwhendeployingtheNeedleElectrodes.
NeedleElectrodeSlider(s)AslidingcontrolontheRFAHandpiecethatallowstheOperatortodeployorretract
theNeedleElectrodes.
NeedleElectrodeTip
Trackers
GraphicalelementsoftheSMARTGuide,representedbythreearrowheads,that
movewiththeNeedleElectrodes.
OperatorTheclinicianorsupportingstaffoperatingtheSonataSystem.
PeripheralZoneMarker
AgraphicalelementoftheSMARTGuide,graphicallyrepresentedbypinstripes,
thatshowsregionsoftheThermalSafetyBorderthatextendbeyondtheultrasound
view.
Point‐of‐UseThelocationandtimewherethedeviceisused.
RadiofrequencyEnergy
(RF)
Ageneraldesignationforenergydeliveredinthefrequencyrangeof3kHzto300
GHz.TheSonataSystemoperatesat460kHz.
RadiofrequencyAblation
(RFA)
Theprocessofdestroyingavolumeoftissueusingradiofrequencyenergyto
sufficientlyelevatetemperaturesforaperiodoftime,whichresultsinthermal
fixationandcoagulativenecrosis.
RFRadiofrequency
RFAHandpiece
Asingle‐usecomponentoftheTreatmentDevicewithdeployableelectrodesused
todeliverthermalenergytofibroids.TheRFAHandpieceattachestotheIUUS
Probe.
RFAHandpieceCableAreusablecablethatconnectstheRFAHandpiecetotheRFGenerator.
Radiofrequency(RF)
GeneratorControlsthedeliveryofenergytotheRFAHandpiece.
Reprocessing
Theentireprocedureofcleaning,disinfecting(ifrequired),andsterilizingtheIUUS
Probewhenbeingusedforthefirsttimeorafteraprocedureinpreparationforthe
nextuse.
SMARTSettingMarginsofAblationinRealTime
SMARTControlA4‐directionalcontrolonthehandleoftheRFAHandpiecethatallowstheOperator
toplanablationdepthandsize.

GlossaryofTerms,Acronyms,andDefinitions
REF‐009LS03818‐009RevTBDOctober2020 xvi
TERMDEFINITION
SMARTGuide
Graphicaloverlayontheultrasoundimagethatdisplaysrequiredinformationfor
targetinganddeploymentoftheTreatmentDevicecomponentsusedtodeliver
radiofrequencyablation.
SMARTTabletUnitontopoftheSystemCartthatprovidesultrasoundimaging,ablationplanning,
andcommunicationswiththeRFGenerator.
StrainReliefTheflexibletaperedelastomerportionsattheendsofthecable
SterilizationAprocessthatrendersproductfreefromviablemicroorganisms.
ThermalSafetyBorder
AgraphicalelementoftheSMARTGuide(greenouterellipse)thatindicatesthe
distancefromtheNeedleElectrodesatwhichtissueissafefromthepotentialof
thermaldamage.
ThermocoupleAnelectricalinstrumentusedtomeasuretemperature.
TreatmentThesonography‐guidedtranscervicalfibroidablationprocedure
(Sonata)TreatmentDeviceTheassemblyoftheRFAHandpieceandtheIUUSProbecreatestheTreatment
Device.
UltrasoundScanPlaneTheplaneinwhichtheultrasoundimageiscollected.Itisdefinedbytheultrasound
ImagingSurfaceorientation.
UltrasoundDisplayScreenThescreenoftheSMARTTabletthatdisplaystheSMARTGuide,GGSsoftwareand
ultrasoundimages.
UserPersonwithpermissiontologintotheSonataSystemuserinterfaceandmanage
theirownimagefilesthroughtheGGSsoftware
WEEEWasteElectronicandElectricalEquipment(WEEE)Regulationsforproperdisposal
withinEuropeanUnion.
