Hologic Affirm breast biopsy guidance system 1.6 Operating instructions

Instructions for Use

For Software Version 1.6

Part Number MAN-02866

Revision 002

May 2012

Affirm Instructions for Use

Table of Contents

Part Number MAN-02866 v

Table of Contents

ListofFigures________________________________________________________________vii

ListofTables__________________________________________________________________ix

Preface________________________________________________________________________xi

1.0IntendedUse...........................................................................................................................................................xi

2.0QualityControl......................................................................................................................................................xi

3.0UserProfiles...........................................................................................................................................................xii

3.1MammographyTechnologist.......................................................................................................................xii

3.2Radiologists,Surgeons..................................................................................................................................xii

3.3MedicalPhysicist............................................................................................................................................xii

4.0TrainingRequirements........................................................................................................................................xii

5.0ProductComplaints............................................................................................................................................xiii

6.0TechnicalSupport...............................................................................................................................................xiii

7.0TermsandDefinitions........................................................................................................................................xiii

8.0InternationalSymbols..........................................................................................................................................xv

9.0Warnings,Cautions,andNotes..........................................................................................................................xv

GeneralInformation_____________________________________________________________1

1.0SystemDescription.................................................................................................................................................1

2.0HowtoHandletheBiopsyGuidanceModule....................................................................................................2

3.0BiopsyGuidanceModuleComponents...............................................................................................................3

4.0BiopsyControlModuleComponents..................................................................................................................4

5.0Safety........................................................................................................................................................................5

6.0ComplianceInformation........................................................................................................................................7

6.1Requirements....................................................................................................................................................7

6.2LabelLocations.................................................................................................................................................7

HowtoInstallorRemovetheSystem______________________________________________9

1.0InstallationofComponents...................................................................................................................................9

1.1HowtoAttachtheBiopsyGuidanceModule..............................................................................................9

1.2HowtoAttachtheBiopsyControlModule................................................................................................10

2.0InstallationandRemovalofAccessories...........................................................................................................11

2.1BiopsyCompressionPaddles.......................................................................................................................11

2.2BiopsyDeviceHolder....................................................................................................................................12

2.3NeedleGuides................................................................................................................................................13

3.0RemovalofMainComponents...........................................................................................................................14

3.1BiopsyControlModule.................................................................................................................................14

3.2BiopsyGuidanceModule..............................................................................................................................14

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Affirm Instructions for Use

Table of Contents

vi Part Number MAN-02866

HowtoUsetheSystem_________________________________________________________15

1.0SystemVerifications.............................................................................................................................................15

1.1ConfirmtheHostConnection.......................................................................................................................15

1.2PerformtheQASNeedleTest.......................................................................................................................15

2.0BiopsyControlModuleScreens..........................................................................................................................19

2.1HomeScreen...................................................................................................................................................19

2.2TargetGuidanceScreen.................................................................................................................................20

2.3JogModeScreen.............................................................................................................................................24

2.4SelectTargetScreen........................................................................................................................................26

3.0SeleniaDimensions...............................................................................................................................................27

3.1StereoViews....................................................................................................................................................27

3.2StereoBiopsyModes......................................................................................................................................28

3.3BiopsyTab.......................................................................................................................................................31

3.4BiopsyStaging................................................................................................................................................32

3.5LesionTargeting.............................................................................................................................................34

3.6VerifythePositionoftheBiopsyDevice.....................................................................................................34

3.7PostBiopsy......................................................................................................................................................35

3.8PrintingStereoImages...................................................................................................................................35

CareandCleaning______________________________________________________________37

1.0GeneralInformation.............................................................................................................................................37

2.0PreventiveMaintenanceSchedule......................................................................................................................37

3.0ForGeneralCleaning............................................................................................................................................38

3.1HowtoCleantheBiopsyControlModuleScreen.....................................................................................38

3.2ToPreventPossibleInjuryorEquipmentDamage...................................................................................39

4.0GeometryCalibration...........................................................................................................................................39

4.1GeometryCalibrationProcedure.................................................................................................................39

Troubleshooting_______________________________________________________________41

1.0AudibleAlerts.......................................................................................................................................................41

2.0ErrorMessages......................................................................................................................................................41

SystemSpecifications__________________________________________________________43

1.0AffirmMeasurements..........................................................................................................................................43

2.0BiopsyGuidanceModule....................................................................................................................................43

3.0BiopsyControlModule........................................................................................................................................43

Forms_________________________________________________________________________45

1.0QASNeedleTestChecklist..................................................................................................................................45

Index_________________________________________________________________________47

Affirm Instructions for Use

Table of Contents

Part Number MAN-02866 vii

List of Figures

Figure1:AffirmontheSeleniaDimensions..................................................................................................................1

Figure2:HowtoLifttheBiopsyGuidanceModule.....................................................................................................2

Figure3:HowtoStoretheBiopsyGuidanceModule..................................................................................................2

Figure4:BiopsyGuidanceModule.................................................................................................................................3

Figure5:BiopsyControlModule....................................................................................................................................4

Figure6:LabelLocation....................................................................................................................................................7

Figure7:InstallationoftheBiopsyGuidanceModule.................................................................................................9

Figure8:AttachmentoftheBiopsyControlModule..................................................................................................10

Figure9:HowtoInstalltheNeedleGuides.................................................................................................................13

Figure10:HomeScreenontheBiopsyControlModule............................................................................................15

Figure11:AdminScreen.................................................................................................................................................16

Figure12:DeviceFieldintheBiopsyTab....................................................................................................................16

Figure13:TheHomeScreen...........................................................................................................................................19

Figure14:TargetGuidanceScreen................................................................................................................................21

Figure15:GreenDifferentialCells................................................................................................................................22

Figure16:YellowandRedCells....................................................................................................................................22

Figure17:AlertSoundsareAudible.............................................................................................................................23

Figure18:AlertSoundsareMuted...............................................................................................................................23

Figure19:JogModeScreen............................................................................................................................................25

Figure20:SelectTargetScreen.......................................................................................................................................26

Figure21:AddaStereoView.........................................................................................................................................27

Figure22:StereoMode...................................................................................................................................................29

Figure23:C‐ArmMode..................................................................................................................................................29

Figure24:SystemStatusIcon.........................................................................................................................................30

Figure25:SystemStatusMenu......................................................................................................................................30

Figure26:SystemDefaultsScreen.................................................................................................................................30

Figure27:TheBiopsyTab..............................................................................................................................................31

Figure28:FunctionButtonsandDataontheBiopsyTab..........................................................................................32

Figure29:StereoPairPrintScreen................................................................................................................................35

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Affirm Instructions for Use

Table of Contents

Part Number MAN-02866 ix

List of Tables

Table1:ComponentsoftheBiopsyGuidanceModule................................................................................................3

Table2:ComponentsoftheBiopsyControlModule....................................................................................................4

Table3:HowtoUsetheSoundButton........................................................................................................................23

Table4:TheC‐ArmStereoModeButton.....................................................................................................................29

Table5:HowtoSelecttheBiopsyMode......................................................................................................................30

Table6:RadiologicTechnologistPreventiveMaintenanceSchedule.......................................................................37

Table7:AffirmAudibleAlerts......................................................................................................................................41

Table8:AffirmErrorMessages.....................................................................................................................................41

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Affirm Instructions for Use

Preface

Intended Use

Part Number MAN-02866 xi

Preface

1.0 Intended Use

UnitedStatesfederallawrestrictsthisdevicetouseby,orontheorderof,aphysician.

TheAffirm™breastbiopsyguidancesystemisanoptionalaccessoryfortheSelenia®

Dimensions®digitalmammographysystem.Itsfunctionistolocalizelesionsaccurately

inthebreastinthreedimensions,usinginformationextractedfromstereotacticpairsof

two‐dimensionalimages.Itisintendedtoprovidetargetingguidanceforinterventional

proceduressuchasbiopsy,presurgicallocalization,ortreatmentdevices.

2.0 Quality Control

FacilitiesthatareACRaccreditedmustfollowthe1999StereotacticBreastBiopsyQuality

ControlManual.FacilitiesthatarenotACRaccreditedcanfollowtheabovemanualor

performtheQASNeedleTestdescribedinthismanualattherequiredinterval.

Affirm Instructions for Use

Preface

User Profiles

xii Part Number MAN-02866

3.0 User Profiles

3.1 Mammography Technologist

• MeetsallrequirementsthatapplytothelocationinwhichtheMammography

Technologistoperates.

• Completedtrainingonthemammographysystem.

• Hastraininginmammographypositions.

• KnowsaboutStereotacticbreastbiopsyprocedures.

• Knowshowtooperateacomputeranditsperipherals.

• Canlift20poundstoshoulderheightwithtwohands(necessaryforupright

stereotacticsystems).

• Understandssterileprocedures.

3.2 Radiologists, Surgeons

• MeetsallrequirementsthatapplytothelocationinwhichthePhysicianoperates.

• KnowsaboutStereotacticbreastbiopsyprocedures.

• Knowshowtooperateacomputeranditsperipherals.

• Understandssterileprocedures.

• Giveslocalanesthesia.

• Knowsaboutbasicsurgicalproceduresforcorebiopsy.

3.3 Medical Physicist

• MeetsallrequirementsthatapplytothelocationinwhichtheMedicalPhysicist

operates.

• Knowsaboutmammography.

• Hasexperiencewithdigitalimaging.

• Knowshowtooperateacomputeranditsperipherals.

4.0 Training Requirements

IntheUnitedStates,usersmustbeRegisteredRadiologicTechnologistsmeetingcriteria

toperformmammography.ThemammographyusersmustmeetallapplicableMQSA

personnelrequirementsunderFDAguidelinesforconventionalanddigital

mammography.

Theuserhasoptionsavailablefortraining,whichincludebutarenotlimitedtoonsite

applications,trainingbyaHologicClinicalServicesSpecialist,andfacilityonthejob

trainingalsoknownaspeertraining.Additionally,theuserʹsinstructionmanualisa

referencefordirectionsonhowtousethesystem.

Affirm Instructions for Use

Preface

Product Complaints

Part Number MAN-02866 xiii

YourHologicrepresentativecanarrangefortrainingbyaclinicalservicesspecialist.

Allusersmustensurethattheyreceivetrainingonproperuseofthesystempriortouse

onpatients.

Hologicdoesnotaccepttheresponsibilityforinjuryordamagefromwrongsystem

operation.

5.0 Product Complaints

Reportanycomplaintorprobleminthequality,reliability,safety,orperformanceofthis

producttoHologic.Ifthedevicehascausedoraddedtopatientinjury,immediately

reporttheincidenttoHologic.(Seethetitlepageforcontactinformation.)

6.0 Technical Support

Refertothetitlepageofthismanualforcontactinformationforproductsupport.

7.0 Terms and Definitions

AffirmThebreastbiopsyguidancesystemfortheSelenia

Dimensions

BiopsyControlModuleTheusercontroldevicefortheAffirmbreastbiopsy

guidancesystem

BiopsyGuidanceModuleHoldsandoperatesthebiopsydevice.Respondsto

commandsfromtheBiopsyControlModuletomovethe

deviceintopositionanddothebiopsy.

CommCommunication

DiffDifferential

C‐ArmModeLetstheC‐armandTubeArmtomovetogethertothe

NeedleApproachanglefortheLocalizationprocedure.

ExposureTechniqueCombinationofxrayparameters(kVp,mAs,filter)foran

acquiredimage

NeedleApproachAngleTheangleofincidenceoftheneedletothebreast

QASQualityAssuranceStandard

SafetyMarginsTheminimumspaceallowedbetweenthebiopsydevice

needlethatisinstalledandcomponentsoftheSelenia

Dimensionssystem.

StereoModeLetstheTubeArmrotateforacquisitionofstereotactic

imageswhiletheC‐Armstaysinposition.

StereotacticProcedureAtypeofexaminationthatallowsstereotacticviewsatthe

AcquisitionWorkstation.

StereotacticViewAspecializedimageviewthatcausestheapplicationto

captureastereotacticimages.

Affirm Instructions for Use

Preface

Terms and Definitions

xiv Part Number MAN-02866

StrokeMarginThesafetymargin(inmm)thatremainsbetweenthefired

needlepositionandthebreastplatform.

ViewThecombinationofonex‐rayimageandaspecifiedsetof

conditionsforimageacquisition.

X‐axis• The(lateral)axisfromlefttorightacrossthebiopsywindow

Y‐axis• The(longitudinal)axisfromfronttobackabovethebiopsy

window

Z‐axis• The(vertical)axisthroughthebiopsywindow



Affirm Instructions for Use

Preface

International Symbols

Part Number MAN-02866 xv

8.0 International Symbols

ThissectiondescribestheInternationalSymbolsonthissystem.



PotentialEqualizationterminal



ProtectiveEarthterminal



ʺOnʺandʺOffʺ(power)forthecomputeranddisplay.



Discardelectricalandelectronicequipmentseparatelyfromstandardwaste.

SenddecommissionedmaterialtoHologicorcontactyourservice

representative.

Manufacturer

DateofManufacture



9.0 Warnings, Cautions, and Notes

DescriptionsofWarnings,Cautions,andNotesusedinthismanual:

WARNING!Theproceduresthatyoumustfollowaccurately

topreventpossibledangerousorfatalinjury.

Warning:Theproceduresthatyoumustfollowaccuratelyto

preventinjury.

Caution:Theproceduresthatyoumustfollowaccuratelytoprevent

thedamagetoequipment,lossofdata,ordamagetofiles

insoftwareapplications.

NoteNotesindicateadditionalinformation.



Affirm Instructions for Use

Chapter 1—General Information

System Description

Part Number MAN-02866 1

Chapter 1

General Information

1.0 System Description

TheAffirmattachestotheSeleniaDimensions.AbiopsydeviceattachestotheAffirm.X‐

andY‐axesmotorsintheAffirmmovethebiopsydeviceleftorrightandforwardorback.

Z‐axismovementismanual.TheAffirmBiopsysystemhastwomaincomponents:

• BiopsyGuidanceModule

• BiopsyControlModule

TheTubeArmontheSeleniaDimensionsmovesseparatelyfromtheCompressionArm

toallowtheacquisitionofstereotacticimagesfortheprocedure.RefertotheInstructions

forUsefortheSeleniaDimensionsforcompleteinformationaboutthatsystem.

AffirmlicensingdisplaysontheAWSscreenasʺStereoLicensedʺ.RefertoLicensing

SetupinSystemToolsoftheOperatingSystem.



Figure1: AffirmontheSeleniaDimensions

FigureLegend

1. BiopsyGuidanceModule

2. BiopsyControlModule



Affirm Instructions for Use

Chapter 1—General Information

How to Handle the Biopsy Guidance Module

2 Part Number MAN-02866

2.0 How to Handle the Biopsy Guidance Module

Caution:Topreventdamageoralignmentproblemswiththe

NeedleGuidanceStage,becarefulwhenyoumovethe

BiopsyGuidanceModule.



Caution:TheAffirmBiopsyGuidanceModuleweighs15pounds.

Whenyoumoveit,besuretohaveasecuregriponthe

handles.

• OnlylifttheBiopsyGuidanceModulewiththehandles.



Figure2: HowtoLifttheBiopsyGuidanceModule

• WhentheBiopsyGuidanceModuleisnotinuse,putthedeviceonitsback.



Figure3: HowtoStoretheBiopsyGuidanceModule

Affirm Instructions for Use

Chapter 1—General Information

Biopsy Guidance Module Components

Part Number MAN-02866 3

3.0 Biopsy Guidance Module Components

TheBiopsyGuidanceModuleinstallsonthefrontoftheSeleniaDimensions.Alocklever

(item8)securesthismoduleinposition.Acable(item7)connectstotheSelenia

Dimensionsforoperationofthebiopsyguidancesystem.



Figure4: BiopsyGuidanceModule

Table1: ComponentsoftheBiopsyGuidanceModule

#NameDescription

1AttachmentHooksTwooneachsideholdtheBiopsyGuidanceModuleontheSelenia

Dimensionsgantry.

2HandlesOneoneachside.HoldbothtolifttheBiopsyGuidanceModule.

3Z‐axisControlKnobsRotateeitherknobtomovethebiopsydevicealongtheZ‐axis.

4Z‐axisSlideRailHoldsthebiopsydeviceholderandprovidesthetrackforZ‐axis

movements.

5FrontNeedleGuideAttachestotheNeedleGuideMountontheBiopsyDeviceHolder.

6BiopsyDeviceHolderHoldsthebiopsydevice.MovesalongtheZ‐axisSlideRailwhena

Z‐axisControlKnobisrotated.

7CableConnectstoSeleniaDimensiontobringpowertotheAffirm.

8LockLeverOneoneachside.EngagebothtolocktheBiopsyGuidanceModule

inpositionandontheSeleniaDimensionsgantry.

9ReceptacleAcceptsthecablefromtheBiopsyControlModule.

Affirm Instructions for Use

Chapter 1—General Information

Biopsy Control Module Components

4 Part Number MAN-02866



4.0 Biopsy Control Module Components

TheBiopsyControlModuleattachestoeithertheleftorrighthandleontheBiopsy

GuidanceModulebymeansofabracket(item5).Thedisplayscreen(item2)isatouch

screenfortheusertoperformthedesiredtasks.MotorEnablebuttons(item3)oneither

sideofthismodule(andattherear)activatemotorizedmovementofthebiopsydevice.



Figure5: BiopsyControlModule

Table2: ComponentsoftheBiopsyControlModule

#NameDescription

1CableConnectstoBiopsyGuidanceModule.

2DisplayScreenShowstargets,systemstatus,nameofthebiopsydevice,andsafety

margins.Touchbuttonsallowoptionselection.

3MotorEnableButtonsFrontandbackbuttonpairsoneithersideofthedisplay.Pressthe

frontandbackbuttonsofeithersideatthesametimetoactivatea

motormovement.

4ArticulatingArm

LockandRelease

Rotatetoreleasethelockandadjustthemodule.Rotateinthe

oppositedirectiontolockthearmandholdthemoduleinthenew

position.

5AttachmentBracketAttachestoeitherhandleoftheBiopsyGuidanceModule.



Hologic Affirm breast biopsy guidance system 1.6 Operating instructions

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