Hologic Affirm Prone Breast Biopsy Guidance System User guide

Brand: Hologic

Model: Affirm Prone Breast Biopsy Guidance System

Type: User guide

Affirm®

Prone Biopsy System

User Guide

For Software Version 1.0

Part Number MAN-04480

Revision 004

June 2018

Hologic, Affirm, ATEC, Eviva, and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its

subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the

property of their respective owners.

This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patents.

Technical Support

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Europe: +32 2 711 4690

Asia: +852 37487700

Australia: +1 800 264 073

All Other: +1 781 999 7750

Email: [email protected]

Affirm Prone Biopsy System User Guide

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MAN-04480 Revision 004 v

Table of Contents

ListofFigures_________________________________________________________________xi

ListofTables_________________________________________________________________xv

1:Introduction__________________________________________________________________1

1.1IntendedUse............................................................................................................................................................1

1.1.1IndicationsforUse....................................................................................................................................1

1.1.2Contraindications.....................................................................................................................................1

1.2EssentialPerformance............................................................................................................................................1

1.3SystemCapabilities.................................................................................................................................................2

1.4UserProfiles.............................................................................................................................................................2

1.4.1MammographyTechnologist..................................................................................................................2

1.4.2Radiologists,Surgeons.............................................................................................................................2

1.4.3MedicalPhysicist......................................................................................................................................2

1.5TrainingRequirements..........................................................................................................................................3

1.6QualityControlRequirements..............................................................................................................................3

1.7WheretoFindtheInstallationInstructions.........................................................................................................3

1.8WheretoFindTechnicalDescriptionInformation.............................................................................................3

1.9WarrantyStatement................................................................................................................................................4

1.10TechnicalSupport...................................................................................................................................................4

1.11ProductComplaints................................................................................................................................................4

1.12HologicCybersecurityStatement.........................................................................................................................4

1.13Symbols....................................................................................................................................................................5

1.14DescriptionsofWarnings,Cautions,andNotes................................................................................................7

2:GeneralInformation___________________________________________________________9

2.1SystemOverview....................................................................................................................................................9

2.1.1C‐ArmOverview....................................................................................................................................10

2.2SafetyInformation................................................................................................................................................11

2.3WarningsandPrecautions...................................................................................................................................11

2.4EmergencyOffSwitches......................................................................................................................................15

2.5Interlocks................................................................................................................................................................15

2.6Compliance............................................................................................................................................................15

2.6.1ComplianceRequirements....................................................................................................................15

2.6.2ComplianceStatements.........................................................................................................................17

2.7LabelLocations.....................................................................................................................................................18

3:SystemControlsandIndicators________________________________________________21

3.1SystemPowerControls........................................................................................................................................21

3.2C‐ArmControls.....................................................................................................................................................22

3.2.1BiopsyArmControls.............................................................................................................................23

3.2.2ControlHandleControls.......................................................................................................................24

3.2.3FootswitchControls...............................................................................................................................24

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3.3PatientPlatformControls....................................................................................................................................25

3.4AcquisitionWorkstationControls......................................................................................................................26

4:Startup,FunctionalTests,andShutdown_______________________________________27

4.1HowtoStarttheSystem.......................................................................................................................................27

4.1.1LogIn........................................................................................................................................................28

4.2FunctionalTests.....................................................................................................................................................29

4.2.1CompressionFunctionalTests..............................................................................................................29

4.2.2C‐armMovementFunctionalTests......................................................................................................30

4.2.3PatientPlatformFunctionalTests.........................................................................................................30

4.3EmergencyOffSwitchesFunctionality..............................................................................................................31

4.4HowtoTurnOfftheSystem...............................................................................................................................31

4.4.1HowtoRemoveAllPowerfromtheSystem......................................................................................31

5:UserInterface‐ControlMonitor_______________________________________________33

5.1SelectFunctiontoPerformScreen......................................................................................................................33

5.2AbouttheTaskbar.................................................................................................................................................34

5.3SelectPatientScreen.............................................................................................................................................36

5.3.1OpenaPatient.........................................................................................................................................37

5.3.2AddaNewPatient.................................................................................................................................38

5.3.3EditthePatientInformation..................................................................................................................38

5.3.4DeleteaPatient.......................................................................................................................................38

5.3.5FiltersforPatients...................................................................................................................................39

5.3.6RefreshtheWorklist...............................................................................................................................41

5.3.7QuerytheWorklist.................................................................................................................................41

5.3.8Admin......................................................................................................................................................41

5.3.9LogOut....................................................................................................................................................41

5.4ProcedureScreen...................................................................................................................................................42

5.4.1HowtoUsetheImplantPresentButton..............................................................................................43

5.4.2AddaProcedure.....................................................................................................................................43

5.4.3AddaView..............................................................................................................................................44

5.4.4EditaView..............................................................................................................................................45

5.4.5HowtoRemoveaView.........................................................................................................................45

5.4.6ProcedureInfo.........................................................................................................................................46

5.4.7CloseaPatient.........................................................................................................................................47

5.5HowtoAccesstheImageReviewFeatures.......................................................................................................47

5.6HowtoAccesstheBiopsyOptions.....................................................................................................................47

5.7OutputGroups......................................................................................................................................................48

5.7.1SelectanOutputGroup.........................................................................................................................48

5.7.2AddorEditanOutputGroup..............................................................................................................48

5.7.3CustomOutput.......................................................................................................................................49

5.8On‐DemandOutputs............................................................................................................................................50

5.8.1Archive.....................................................................................................................................................50

5.8.2Export.......................................................................................................................................................51

5.8.3Print..........................................................................................................................................................52

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6:UserInterface‐BiopsyControlModule________________________________________55

6.1BiopsyControlModuleScreens..........................................................................................................................55

6.1.1HomeScreen...........................................................................................................................................55

6.1.2AbouttheTaskbarfortheBiopsyControlModule...........................................................................56

6.1.3TargetGuidanceScreen.........................................................................................................................57

7:Images______________________________________________________________________63

7.1ImageDisplayScreen...........................................................................................................................................63

7.1.1ConventionalImagingSequenceofEvents.........................................................................................64

7.1.2TomosynthesisImagingSequenceofEvents......................................................................................64

7.2HowtoSettheExposureParameters.................................................................................................................64

7.2.1SelecttheExposureMode.....................................................................................................................64

7.2.2HowtoUsetheAECSensor.................................................................................................................64

7.3HowtoAcquireanImage....................................................................................................................................65

7.3.1HowtoAcceptaRejectedImage..........................................................................................................66

7.3.2HowtoCorrectandReprocessImplantImages.................................................................................66

7.4HowtoReviewtheImages..................................................................................................................................67

7.4.1TheImageReviewToolsTab................................................................................................................68

7.4.2OtherImageReviewTools....................................................................................................................69

7.4.3SliceIndicator..........................................................................................................................................70

8:Biopsy______________________________________________________________________71

8.1BiopsyApproach..................................................................................................................................................71

8.2BiopsyCoordinateSystem...................................................................................................................................72

8.3BiopsyViews.........................................................................................................................................................73

8.4BiopsyTab.............................................................................................................................................................73

8.4.1BiopsyOptions........................................................................................................................................74

8.5LesionTargetingina2DBiopsyProcedure......................................................................................................76

8.5.1LateralNeedleApproach......................................................................................................................77

8.5.2VerifythePositionoftheBiopsyDevice.............................................................................................77

8.6LesionTargetingina3DBiopsyProcedure......................................................................................................78

8.6.1LateralNeedleApproach......................................................................................................................79

8.6.2VerifythePositionoftheBiopsyDevice.............................................................................................79

8.6.3ProjectTargetsonPost‐FireScoutImage............................................................................................80

8.7LesionTargetingUsingMulti‐Pass....................................................................................................................80

8.8PostBiopsy.............................................................................................................................................................83

9:Accessories__________________________________________________________________85

9.1MaximumComfortPackage...............................................................................................................................85

9.2BiopsyPaddles......................................................................................................................................................88

9.2.1HowtoInstallorRemoveaPaddle.....................................................................................................89

9.3BiopsyDevicesandComponents.......................................................................................................................90

9.3.1NeedleGuides.........................................................................................................................................90

9.3.2BiopsyDeviceAdapter..........................................................................................................................91

9.3.3BiopsyDevice..........................................................................................................................................92

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9.4EquipmentDrapeSet...........................................................................................................................................93

9.4.1Symbols....................................................................................................................................................95

9.5AccessoryCart.......................................................................................................................................................96

9.5.1PadHangers............................................................................................................................................96

9.5.2PaddleHolders.......................................................................................................................................97

10:SampleClinicalSequences___________________________________________________99

10.1ExampleStereotacticBiopsyProcedure.............................................................................................................99

10.2ExampleTomographyBiopsyProcedure........................................................................................................100

10.3ExampleSequenceofOperation.......................................................................................................................101

11:QualityControl____________________________________________________________107

11.1RequiredQualityControlProcedures..............................................................................................................107

11.2HowtoAccessQualityControlTasks.............................................................................................................108

11.3QASTest...............................................................................................................................................................110

11.4GainCalibration..................................................................................................................................................113

11.5GeometryCalibration.........................................................................................................................................114

12:CareandCleaning__________________________________________________________115

12.1Cleaning...............................................................................................................................................................115

12.1.1GeneralInformationAboutCleaning................................................................................................115

12.1.2ForGeneralCleaning...........................................................................................................................115

12.1.3HowtoCleantheBiopsyControlModuleScreen...........................................................................116

12.1.4ToPreventPossibleInjuryorEquipmentDamage..........................................................................116

12.2GeneralInformationaboutEquipmentDrapes..............................................................................................117

12.3PreventiveMaintenanceSchedulefortheUser..............................................................................................118

12.4PreventiveMaintenanceScheduleforService................................................................................................119

13:SystemAdministrationInterface_____________________________________________121

13.1TheAdminScreen...............................................................................................................................................121

13.2TheAboutScreen................................................................................................................................................123

13.3ChangetheUserLanguagePreference............................................................................................................124

13.4HowtoAccesstheSystemTools......................................................................................................................124

13.4.1SystemToolsfortheRadiologicTechnologistManager.................................................................125

13.4.2RemoteAccesstoImageReports........................................................................................................126

13.5ArchiveTool........................................................................................................................................................128

AppendixA:Specifications____________________________________________________131

A.1ProductMeasurements......................................................................................................................................131

A.2OperationandStorageEnvironment...............................................................................................................132

A.2.1GeneralConditionsforOperation......................................................................................................132

A.2.2GeneralConditionsforTransportandStorage................................................................................133

A.3ElectricalInput....................................................................................................................................................133

A.3.1Generator/Gantry..................................................................................................................................133

A.3.2AcquisitionWorkstation......................................................................................................................133

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A.4GantryTechnicalInformation...........................................................................................................................133

A.4.1C‐arm......................................................................................................................................................133

A.4.2CompressionSystem............................................................................................................................134

A.4.3BiopsyGuidanceModule....................................................................................................................134

A.4.4X‐rayTube.............................................................................................................................................134

A.4.5X‐rayBeamFiltrationandOutput.....................................................................................................134

A.4.6X‐rayGenerator....................................................................................................................................135

A.4.7ImageReceptorTechnicalInformation.............................................................................................136

A.4.8Shielding................................................................................................................................................136

A.5AcquisitionWorkstationTechnicalInformation............................................................................................136

A.5.1NetworkEnvironment.........................................................................................................................136

A.5.2AcquisitionWorkstationCart.............................................................................................................136

AppendixB:SystemMessagesandAlerts________________________________________137

B.1ErrorRecoveryandTroubleshooting...............................................................................................................137

B.2TypesofMessages..............................................................................................................................................137

B.2.1FaultLevels...........................................................................................................................................137

B.2.2SystemMessages..................................................................................................................................138

B.3UPSMessages......................................................................................................................................................140

AppendixC:UseinaMobileEnvironment______________________________________141

C.1GeneralInformation...........................................................................................................................................141

C.2ConditionsforSafetyandOtherPrecautions.................................................................................................141

C.3SpecificationsforMobileUse............................................................................................................................142

C.3.1ShockandVibrationLimits.................................................................................................................142

C.4PreparetheSystemforTravel...........................................................................................................................142

C.5PreparetheSystemforUse................................................................................................................................148

C.6TesttheSystemafterTravel..............................................................................................................................148

C.6.1FunctionalTestsAfterTravel..............................................................................................................148

C.6.2QualityControlTestsAfterTravel.....................................................................................................148

AppendixD:DoseConversionTablesfortheMedicalPhysicist____________________149

AppendixE:CNRCorrectionforBiopsy_________________________________________153

E.1CNRCorrectionforStereotacticBiopsy..........................................................................................................153

E.1.1AECTable0(StandardStereotacticBiopsyDose)...........................................................................153

E.1.2AECTable1(EUREFStereotacticBiopsyDose)..............................................................................153

E.2CNRCorrectionforBiopsyUnderTomosynthesisOption..........................................................................153

E.2.1AECTable0(TomosynthesisOption:StandardTomoDose)........................................................153

E.2.2AECTable1(EUREFTomosynthesisBiopsyDose)........................................................................153

AppendixF:TechniqueTables_________________________________________________155

F.1RecommendedTechniqueTableforStereotacticProcedures.......................................................................155

F.2RecommendedTechniqueTableforTomosynthesisProcedures................................................................156

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AppendixG:AncillaryPartsforBiopsy__________________________________________157

G.1HologicFactory‐VerifiedBiopsyDevices........................................................................................................157

AppendixH:Forms____________________________________________________________159

H.1QASTestChecklist.............................................................................................................................................159

H.2GeometryCalibration.........................................................................................................................................161

H.3GainCalibration..................................................................................................................................................163

GlossaryofTerms_____________________________________________________________165

Index________________________________________________________________________167

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List of Figures

Figure1:AffirmProneBiopsySystem............................................................................................................................9

Figure2:C‐armOverview..............................................................................................................................................10

Figure3:EmergencyOffSwitchFunctionality............................................................................................................15

Figure4:LabelLocations................................................................................................................................................18

Figure5:SystemPowerControls..................................................................................................................................21

Figure6:C‐armControlsandDisplays........................................................................................................................22

Figure7:BiopsyArm–DetailedView.........................................................................................................................23

Figure8:ControlHandle‐‐DetailedView..................................................................................................................24

Figure9:Footswitch–DetailedView...........................................................................................................................24

Figure10:PatientPlatformControls.............................................................................................................................25

Figure11:AcquisitionWorkstationControls..............................................................................................................26

Figure12:StartupScreen................................................................................................................................................27

Figure13:SelectanOperator(LogIn)Screen..............................................................................................................28

Figure14:EmergencyOffSwitchFunctionality..........................................................................................................31

Figure15:SelectFunctiontoPerformScreen...............................................................................................................33

Figure16:SelectPatientScreen......................................................................................................................................36

Figure17:AddPatientScreen........................................................................................................................................38

Figure18:FilterTabinthePatientFilterScreen..........................................................................................................39

Figure19:ProcedureScreen...........................................................................................................................................42

Figure20:AddProcedureDialogBox..........................................................................................................................43

Figure21:AddViewScreen...........................................................................................................................................44

Figure22:EditViewScreen............................................................................................................................................45

Figure23:TheProcedureInfoWindow.......................................................................................................................46

Figure24:OutputGroupsField.....................................................................................................................................48

Figure25:AnExampleCustomOutputGroup...........................................................................................................49

Figure26:OnDemandArchiveScreen........................................................................................................................51

Figure27:PrintScreen....................................................................................................................................................53

Figure28:StereoPairPrintScreen................................................................................................................................54

Figure29:HomeScreen..................................................................................................................................................55

Figure30:TaskbarfortheBiopsyControlModule.....................................................................................................56

Figure31:TargetGuidanceScreen................................................................................................................................57

Figure32:SelectTargetScreen.......................................................................................................................................59

Figure33:JogModeScreen............................................................................................................................................60

Figure34:AECAdjustScreen........................................................................................................................................61

Figure35:ImageDisplayScreen....................................................................................................................................63

Figure36:ExposureinProgress....................................................................................................................................65

Figure37:ExposureComplete.......................................................................................................................................65

Figure38:ToolsTab........................................................................................................................................................67

Figure39:ImageReviewTools......................................................................................................................................68

Figure40:ExposureIndex..............................................................................................................................................69

Figure41:DisplayModes...............................................................................................................................................69

Figure42:SliceIndicator.................................................................................................................................................70

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Figure43:BiopsyArmAnglesofRotation...................................................................................................................71

Figure44:DirectionalMovementfortheX,Y,ZAxes...............................................................................................72

Figure45:BiopsyTab......................................................................................................................................................73

Figure46:FunctionButtonsandDataontheBiopsyTab..........................................................................................74

Figure47:Multi‐PassOptions........................................................................................................................................80

Figure48:FourOffsetTargetPointsEstablishedAroundCenterTargetPoint......................................................81

Figure49:3mmSpacingofOffsetPoints.....................................................................................................................82

Figure50:5mmSpacingofOffsetPoints.....................................................................................................................82

Figure51:SinglePointTargetSelected.........................................................................................................................82

Figure52:SinglePointTargetDeselected....................................................................................................................82

Figure53:Multi‐PassTargetSelected...........................................................................................................................82

Figure54:Multi‐PassTargetDeselected.......................................................................................................................82

Figure55:ExampleofBiopsyOrderofTargetSets....................................................................................................83

Figure56:BiopsyOrderofaThreeOffsetTarget........................................................................................................83

Figure57:BiopsyOrderofaFourOffsetTarget.........................................................................................................83

Figure58:BiopsyOrderofaFiveOffsetTarget..........................................................................................................83

Figure59:HowtoInstallaCompressionPaddle........................................................................................................89

Figure60:HowtoInstalltheNeedleGuides...............................................................................................................90

Figure61:AttachtheBiopsyDeviceAdapter..............................................................................................................91

Figure62:AttachtheBiopsyDevice.............................................................................................................................92

Figure63:PadHangerInstallation................................................................................................................................96

Figure64:PaddleHolderInstallation...........................................................................................................................97

Figure65:AdminScreenShowingQASTest.............................................................................................................110

Figure66:QASTestInfoDialogBox...........................................................................................................................111

Figure67:DeviceFieldintheBiopsyTab..................................................................................................................111

Figure68:AdminScreen...............................................................................................................................................113

Figure69:AdminScreen...............................................................................................................................................114

Figure70:AreastoProtectwithDrapes.....................................................................................................................117

Figure71:AdminScreen...............................................................................................................................................121

Figure72:AboutScreenwiththeSystemTabShowing...........................................................................................123

Figure73:SystemToolsScreen....................................................................................................................................125

Figure74:RemoteLogonScreenforServiceTools...................................................................................................126

Figure75:ServiceToolsWelcomeScreen...................................................................................................................126

Figure76:CreateImageReportParameters...............................................................................................................127

Figure77:CreateImageReport...................................................................................................................................127

Figure78:ArchiveButton.............................................................................................................................................128

Figure79:MultiPatientOnDemandArchiveScreen...............................................................................................128

Figure80:ExportScreen...............................................................................................................................................130

Figure81:GantryandGeneratorDimensions...........................................................................................................131

Figure82:AcquisitionWorkstationDimensions.......................................................................................................132

Figure83:UPSLCDDisplay........................................................................................................................................140

Figure84:SettheC‐armCradle...................................................................................................................................143

Figure85:SettheC‐armHeightwiththeHeightTool.............................................................................................143

Figure86:LocktheBiopsyArmwiththeHeightTool.............................................................................................144

Figure87:CorrectFootswitchStorage........................................................................................................................145

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Figure88:AlignmentofMarkingsontheC‐armwiththeC‐armCradle..............................................................146

Figure89:MouseHolder(2)andKeyboardTrayLockKnob(1)............................................................................147

Figure90:SettheLockKnobtoLockedPosition......................................................................................................147

Figure91:ReleasetheLockKnobsontheMonitors.................................................................................................147

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List of Tables

Table1:SystemLabels....................................................................................................................................................19

Table2:CompressionTests............................................................................................................................................29

Table3:C‐armTests........................................................................................................................................................30

Table4:PatientPlatformTests.......................................................................................................................................30

Table5:TaskbarMenus..................................................................................................................................................34

Table6:TheSelectPatientScreen..................................................................................................................................37

Table7:FilterTabOptions(RequireAccessPrivileges)............................................................................................40

Table8:TheProcedureScreen.......................................................................................................................................42

Table9:InstallationandUseoftheMaximumComfortPackage............................................................................85

Table10:InstallationoftheArmThroughMaximumComfortPackage................................................................87

Table11:UseoftheArmThroughMaximumComfortPackage..............................................................................88

Table12:RequiredProcedures....................................................................................................................................107

Table13:OperatorPreventiveMaintenanceSchedule.............................................................................................118

Table14:ServiceEngineerPreventiveMaintenance................................................................................................119

Table15:AdminScreenFunctions..............................................................................................................................121

Table16:RadiologicTechnologistManager—SystemToolsFunctions.................................................................125

Table17:MaximummAasaFunctionofkV.............................................................................................................135

Table18:SystemMessages...........................................................................................................................................138

Table19:HologicFactory‐VerifiedBiopsyDevices..................................................................................................157



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MAN-04480 Revision 004 Page 1

1: Introduction

Readallthisinformationcarefullybeforeoperatingthesystem.Followallwarningsand

precautionsasstatedinthismanual.Keepthismanualavailableduringprocedures.

Physiciansshouldtellpatientsaboutallpotentialrisksandadverseeventsdescribedin

thismanualwithrespecttotheoperationofthesystem.

Note

Hologicconfiguressomesystemstomeetspecificrequirements.Yoursystem

configurationmaynothavealltheoptionsandaccessoriesincludedinthismanual.



1.1 Intended Use



Caution:Federallawrestrictsthisdevicetosalebyorontheorderofaphysician.



TheAffirm®pronebiopsysystemisintendedforlesionlocationforbiopsywhilethe

patientisinthepronepositiontoprovideguidanceforinterventionalpurposes(suchas

biopsy,pre‐surgicallocalizationortreatmentdevices).

1.1.1 Indications for Use

TheAffirmpronebiopsysystemcombinesthefunctionofastandardx‐ray

mammographyunitwiththatofalesionlocalizationsystemtoproduceadevicethathas

specificapplicationinfirstaccuratelylocalizinglesionsinthebreastintwoand/orthree

dimensions,andthenprovidingguidanceforinterventionalpurposes(suchasbiopsy,

pre‐surgicallocalizationortreatmentdevices)forlesionsdeterminedtobesuspicious

throughpriormammographicexamination.

1.1.2 Contraindications

• Patientweighsmorethan181kg(400pounds).

• Inabilitytovisualizethelesionundermammographicimaging.

• Patientcannotremaininapronepositionduringtheentireprocedure.

1.2 Essential Performance

TheessentialperformancerequirementsoftheAffirmpronebiopsysystemisasdefined

inIEC‐60601‐2‐45:2005.Theseinclude:accuracyofloadingfactors,automaticcontrol

system,imagingperformance,missedtissueatchestwallside,breastcompression

device,linearityofairkermaoverlimitedintervalsofloadingfactors,andreproducibility

oftheX‐radiationoutput.

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1.3 System Capabilities

TheAffirmpronebiopsysystemisatomosynthesis‐capablemammographysystemfor

performingbreastbiopsiesonpatientslyingintheproneposition.Thesystemlocalizes

suspiciouslesions,asdeterminedthroughpriormammographicexaminations,using

eitherstereotacticortomosynthesistechniques.Thesystemthenaffordsaphysicianthe

capacityofperformingvacuum‐assistedneedlecorebiopsyorneedle(wire)localization

ofthelesion.

Localizationcanbeaccomplishedeitherviaconventionalstereotacticimaging,orby

examinationofatomosynthesisdataset.Withtomosynthesis,theimageplaneor“slice”

mostfullycontainingthesuspectedlesionischosenbythephysicianfromthedatasetto

identifythelesiondepthwithinthebreast.

1.4 User Profiles

1.4.1 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.

• Understandsstereotacticbreastbiopsyprocedures.

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

• Understandssterileprocedures.

1.4.2 Radiologists, Surgeons

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

• Understandsstereotacticbreastbiopsyprocedures.

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

• Understandssterileprocedures.

• Giveslocalanesthesia.

• Understandsbasicsurgicalproceduresforcorebiopsy.

1.4.3 Medical Physicist

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

operates.

• Understandsmammography.

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

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

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1.5 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

• Onsiteonthejobtrainingalsoknownaspeertraining

Additionally,theusermanualisaguidefordirectionsonhowtousethesystem.

Allusersmustmakesurethattheyreceivetrainingoncorrectoperationofthesystem

beforeuseonpatients.

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

operation.

1.6 Quality Control Requirements

PerformallQualityControltestswithinthecorrecttimeframe.

1.7 Where to Find the Installation Instructions

InstallationinstructionsareavailableintheServiceManual.

1.8 Where to Find Technical Description Information

TechnicaldescriptioninformationisavailableintheServiceManual.

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1.9 Warranty Statement

ExceptasotherwiseexpresslystatedintheAgreement:i)Equipmentmanufacturedby

HologiciswarrantedtotheoriginalCustomertoperformsubstantiallyinaccordance

withpublishedproductspecificationsforone(1)yearstartingfromthedateofshipment,

orifInstallationisrequired,fromthedateofInstallation(“WarrantyPeriod”);ii)digital

imagingmammographyx‐raytubesarewarrantedfortwenty‐four(24)months,during

whichthex‐raytubesarefullywarrantedforthefirsttwelve(12)monthsandare

warrantedonastraight‐lineproratedbasisduringmonths13‐24;iii)replacementparts

andremanufactureditemsarewarrantedfortheremainderoftheWarrantyPeriodor

ninety(90)daysfromshipment,whicheverislonger;iv)consumableSuppliesare

warrantedtoconformtopublishedspecificationsforaperiodendingontheexpiration

dateshownontheirrespectivepackages;v)licensedSoftwareiswarrantedtooperatein

accordancewithpublishedspecifications;vi)Servicesarewarrantedtobesuppliedina

workman‐likemanner;vii)non‐HologicManufacturedEquipmentiswarrantedthrough

itsmanufacturerandsuchmanufacturer’swarrantiesshallextendtoHologic’s

customers,totheextentpermittedbythemanufacturerofsuchnon‐Hologic

ManufacturedEquipment.HologicdoesnotwarrantthatuseofProductswillbe

uninterruptedorerror‐free,orthatProductswilloperatewithnon‐Hologicauthorized

third‐partyproducts.Thesewarrantiesdonotapplytoanyitemthatis:(a)repaired,

moved,oralteredotherthanbyHologicauthorizedservicepersonnel;(b)subjectedto

physical(includingthermalorelectrical)abuse,stress,ormisuse;(c)stored,maintained,

oroperatedinanymannerinconsistentwithapplicableHologicspecificationsor

instructions,includingCustomer’srefusaltoallowHologicrecommendedSoftware

upgrades;or(d)designatedassuppliedsubjecttoanon‐Hologicwarrantyoronapre‐

releaseor“as‐is”basis.

1.10 Technical Support

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

1.11 Product Complaints

Reportanycomplaintsorproblems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.

1.12 Hologic Cybersecurity Statement

Hologiccontinuouslyteststhecurrentstateofcomputerandnetworksecurityto

examinepossiblesecurityproblems.Whennecessary,Hologicprovidestheupdatesto

theproduct.

ForCybersecurityBestPracticesdocumentsforHologicproducts,refertotheHologic

Internetsiteatwww.Hologic.com.

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Hologic Affirm Prone Breast Biopsy Guidance System User guide

Brand: Hologic

Model: Affirm Prone Breast Biopsy Guidance System

Type: User guide

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Hologic Affirm Prone Breast Biopsy Guidance System User guide

Hologic Affirm Prone Breast Biopsy Guidance System User guide

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