Hologic InSight 2 Mini C-arm User guide

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TITLE DOCUMENT NUMBER REV

INSIGHT 2 MINI C-ARM

USER GUIDE AW-15139 005

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written permission from Hologic.

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Artwork consists of:

 Eighty-eight (88) 8.5 x 11 inch pages.

InSight™ 2 Mini C-arm User Guide

MAN-04857 Revision 005

InSight™ 2

Mini C-arm Imaging System

User Guide

Part Number: MAN-04857

Revision 005

September 2017



Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a

physician (or properly licensed practitioner).



Customer Support

Toll Free in USA: +1.800.321.4659

Email: [email protected]

In Europe, South America, or Asia, contact your local dealer or distributor.

Hologic, Fluoroscan, InSight, MegaView, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or

its subsidiaries in the U.S. and/or other countries. Any other product and company names mentioned herein are the trademarks 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.

InSight 2 Mini C-arm User Guide

MAN-04857 Revision 005 i

TableofContents

1IndicationsforUse....................................................................................................................1

2RadiationSafety........................................................................................................................1

2.1General ................................................................................................................................................ 2

2.2RadiationDoseandDoseRate ........................................................................................................ 2

2.3X‐rayShielding .................................................................................................................................. 3

3RegulationsforX‐rayEquipment ..........................................................................................3

3.1UnitedStatesFederalandStateRegulations................................................................................. 3

3.2IECRegulations ................................................................................................................................. 3

3.3CanadianRegulations....................................................................................................................... 4

4EMI...............................................................................................................................................4

5Accessories .................................................................................................................................4

6InSight2SystemLabels ..........................................................................................................5

6.1SystemMainLabel ............................................................................................................................ 5

6.2X‐raySystemWarningLabel ........................................................................................................... 6

6.3ElectricShockWarningLabel.......................................................................................................... 6

6.4NoPushingWarningLabel.............................................................................................................. 6

6.5ISO7010‐M002Label......................................................................................................................... 7

7Symbols ......................................................................................................................................7

8SafetyHazards...........................................................................................................................9

9SystemComponents...............................................................................................................14

10ControlsandIndicators .......................................................................................................15

10.1X‐rayHeadControlPanel ............................................................................................................ 15

10.2KeyboardControls ........................................................................................................................15

10.3InSight2SystemFootswitchFunctions...................................................................................... 17

10.3.1AcquireanX‐rayImage ...................................................................................................... 18

10.3.2DisplayaMegaViewImage ............................................................................................... 18

10.3.3TaganImage ........................................................................................................................ 18

10.3.4SaveanImage....................................................................................................................... 18

10.3.5PrintanImage ...................................................................................................................... 18

11UsingtheSystem ..................................................................................................................19

11.1MovingtheSystem........................................................................................................................ 19

11.2AdjustingtheC‐arm...................................................................................................................... 20

11.3SterileC‐armDrape....................................................................................................................... 21

11.4PoweringUptheSystem .............................................................................................................. 22

InSight 2 Mini C-arm User Guide

ii MAN-04857 Revision 005

11.5PoweringDowntheSystem......................................................................................................... 22

12ConfiguringtheApplication ..............................................................................................23

12.1SystemConfigurationUserInterface ......................................................................................... 23

12.2System ............................................................................................................................................. 23

12.3DICOMSendOptions................................................................................................................... 26

12.3.1DICOMPrintOptions ......................................................................................................... 28

12.4WorklistConfiguration................................................................................................................. 30

12.4.1Users ...................................................................................................................................... 32

12.5PhysicianPreferences.................................................................................................................... 33

12.6PhysicianPreferences—ImageAcquisition............................................................................. 34

12.7PhysicianPreferences—ImageProcessing............................................................................... 37

12.8PhysicianPreferences—ImageManagement .......................................................................... 39

12.9AdministrativeSettingsPage ...................................................................................................... 40

13UsingtheInSight2Application ........................................................................................41

13.1MainScreen .................................................................................................................................... 41

13.2ImageAcquisitionSession ........................................................................................................... 47

13.2.1SelectorEnterPatientWindow ......................................................................................... 47

13.2.2ImageAcquisitionScreen ................................................................................................... 48

13.2.3SelectReferenceImagesWindow...................................................................................... 54

13.3ReviewImagesSession................................................................................................................. 56

13.3.1SelectStudyforReviewWindow...................................................................................... 56

13.3.2ReviewScreen....................................................................................................................... 58

13.3.3EnhancedDisplayedImageScreen ................................................................................... 61

13.4MaintainingPatientStudyRecords ............................................................................................ 62

13.4.1UpdatePatientStudyInformationWindow.................................................................... 62

13.5ExportImages ................................................................................................................................ 63

13.5.1ExportfromReviewImagesScreen .................................................................................. 63

13.5.2ExportfromReviewImagesScreen .................................................................................. 65

13.6ImportImagesWindow ............................................................................................................... 68

13.7DeleteImagesWindow................................................................................................................. 70

13.8ViewDICOMQueueWindow .................................................................................................... 72

14SystemMaintenance ............................................................................................................74

14.1SystemBackup............................................................................................................................... 74

14.2SystemRecover.............................................................................................................................. 74

14.3Cleaning .......................................................................................................................................... 74

14.3.1RecommendedCleaningAgents ....................................................................................... 74

14.4PreventativeMaintenance............................................................................................................ 75

InSight 2 Mini C-arm User Guide

MAN-04857 Revision 005 iii

ListofFigures

Figure1:InSight2MiniC‐arm .................................................................................................. 1

Figure2:SystemMainLabel ...................................................................................................... 5

Figure3:X‐raySystemWarning................................................................................................ 6

Figure4:ElectricShockWarning............................................................................................... 6

Figure5:NoPushingWarning*................................................................................................. 6

Figure6:ISO7010‐M002Label.................................................................................................. 7

Figure7:WirelessFootswitch .................................................................................................. 17

Figure8:TransportPositionKnob .......................................................................................... 19

Figure9:RearCasters................................................................................................................ 20

Figure10:AdjustingtheC‐arm................................................................................................ 21

Figure11:SterileC‐armDrape................................................................................................. 21

Figure12:SystemConfigurationMenu.................................................................................. 23

Figure13:System ....................................................................................................................... 24

Figure14:DICOMSendOptions............................................................................................. 26

Figure15:DICOMPrintOptions............................................................................................. 28

Figure16:WorklistConfiguration........................................................................................... 30

Figure17:Users.......................................................................................................................... 32

Figure18:PhysicianPreferences ............................................................................................. 33

Figure19:PhysicianPreferences—ImageAcquisition....................................................... 35

Figure20:PhysicianPreferences—ImageProcessing ........................................................ 37

Figure21:PhysicianPreferences—ImageManagement .................................................... 39

Figure22:MainScreen .............................................................................................................. 41

Figure23:SystemConfigurationPull‐downMenu............................................................. 42

Figure24:SystemConfigurationMenu................................................................................. 43

Figure25:ToolsPull‐downMenu ........................................................................................... 45

Figure26:SelectorEnterPatientWindow............................................................................. 47

Figure27:ImageAcquisitionScreen....................................................................................... 48

Figure28:ImageEffectsMenu................................................................................................. 49

Figure29:ConfigureImageAreaMenu................................................................................. 50

Figure30:ImageAcquisitionScreenButtons ....................................................................... 51

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iv MAN-04857 Revision 005

Figure31:ReferenceImagesWindow .................................................................................... 54

Figure32:StudyforReview ..................................................................................................... 56

Figure33:ReviewImagesScreen ............................................................................................ 58

Figure34:PatientDetails .......................................................................................................... 60

Figure35:VISTADetails........................................................................................................... 60

Figure36:EnhancedDisplayedImageScreen....................................................................... 61

Figure37:ToolsMenu.............................................................................................................. 62

Figure38:ImageExportfromReviewScreen ....................................................................... 64

Figure39:ExportImages......................................................................................................... 64

Figure40:ToolMenuExport.................................................................................................... 65

Figure41:ExportImagesfromToolMenu ............................................................................ 65

Figure42:ToolsMenu............................................................................................................... 68

Figure43:ImportImagesWindow ......................................................................................... 68

Figure44:DeleteImages........................................................................................................... 70

Figure45:PatientSelected........................................................................................................ 71

Figure46:ImageselectedforDeletion.................................................................................... 71

Figure47:ViewDICOMQueue............................................................................................... 73

InSight 2 Mini C-arm User Guide

MAN-04857 Revision 005 v

ListofTables

Table1SafetyHazards................................................................................................................9

Table2:SystemComponents...................................................................................................14

Table3X‐rayHeadControlPanel...........................................................................................15

Table4KeyboardControls.......................................................................................................15

Table5FootswitchPedalFunctions........................................................................................17

Table6ConditioningSchedule................................................................................................22

Table7SystemConfigurationUserInterface........................................................................23

Table8SystemPage..................................................................................................................25

Table9DICOMSendOptionsPage........................................................................................26

Table10DICOMSendOptionsPage,ButtonFunctions......................................................27

Table11DICOMPrintOptionsPage,Section/FieldDescriptions......................................28

Table12DICOMPrintOptionsPage,ButtonFunctions......................................................29

Table13WorklistConfiguration,SectionDescriptions.......................................................30

Table14WorklistConfiguration,ButtonFunctions.............................................................31

Table15UsersPage,Section/FieldDescriptions...................................................................32

Table16UsersPage,ButtonFunctions...................................................................................32

Table17PhysicianPreferences,Section/FieldDescriptions................................................33

Table18PhysicianPreferences,ButtonFunctions................................................................34

Table19PhysicianPreferences,ImageAcquisitionTab,Section/FieldDescriptions......36

Table20PhysicianPreferences,ImageProcessingTab,Section/FieldDescriptions.......38

Table21PhysicianPreferences,ImageManagementTab,Section/FieldDescriptions...39

Table22AdministrativeSettings,SectionDescriptions.......................................................40

Table23AdministrativeSettings,ButtonFunctions............................................................40

Table24MainScreenOptions..................................................................................................41

Table25SystemConfigurationMenu....................................................................................43

Table26ToolsMenu..................................................................................................................45

Table27SelectorEnterPatientWindow,Section/FieldDescriptions...............................47

Table28SelectorEnterPatientWindow,ButtonFunctions...............................................48

Table29ImageAcquisitionScreen..........................................................................................48

Table30ImageEffectsMenu...................................................................................................49

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vi MAN-04857 Revision 005

Table31ConfigureImageAreaMenu....................................................................................50

Table32ImageAcquisitionScreen,ButtonFunctions.........................................................51

Table33ToolSet........................................................................................................................52

Table34SelectReferenceImagesWindow,SectionDescriptions......................................55

Table35SelectReferenceImagesWindow,ButtonFunctions............................................55

Table36SelectStudyforReviewWindow,Section/FieldDescriptions............................57

Table37SelectStudyforReviewWindow,ButtonFunctions............................................57

Table38ReviewScreen,ButtonFunctions............................................................................58

Table39DetailedImageViewingScreen,ButtonFunctions...............................................61

Table40UpdatePatient/StudyInformationWindow,SectionDescriptions....................62

Table41UpdatePatient/StudyInformationWindow,ButtonFunctions.........................63

Table42ExportWindow,SectionDescriptions....................................................................66

Table43ExportWindow,ButtonFunctions..........................................................................67

Table44ImportWindow,SectionDescriptions....................................................................69

Table45ImportWindow,ButtonFunctions..........................................................................69

Table46DeleteImagesWindow,SectionDescriptions.......................................................72

Table47DeleteImagesWindow,ButtonFunctions.............................................................72

Table48QueueWindow,SectionDescriptionandButtonFunctions...............................73

InSight 2 Mini C-arm User Guide

Indications for Use

MAN-04857 Revision 005 1

1 Indications for Use

TheInSight™2MiniC‐armisaMiniC‐armFluoroscopicImagingSystem

designedtoprovidephysicianswithgeneralfluoroscopicvisualizationof

apatient,including,butnotlimitedtosurgicalorthopedicandpodiatry

use,criticalandemergencycareprocedures,andlightanatomyimaging

situations.

Figure1 InSight2MiniC‐arm

2 Radiation Safety

Improperimagingproceduresorthefailuretoobserveradiationsafety

andtechniquefactorrecommendationscouldresultinincreased

exposure.Itistheoperatorʹsresponsibilitytoobserveallsafety

proceduresandtokeepradiationexposuresAsLowAsReasonably

Achievable(ALARA)andtocomplywithallnational,stateandlocal

regulatoryrequirements.

InSight 2 Mini C-arm User Guide

Radiation Safety

2MAN-04857 Revision 005

Hologicrecommendsthatallmembersoftheoperatingstaffweara

radiationmonitoringdevice.ThisisusuallyafilmbadgeorTLD

(thermoluminescentdosimetry)dosimeterwhichwillrecordany

radiationdoseoveraspecificperiodoftime.Thephysicianshouldweara

ringbadgetorecordanyexposuretohis/herhands.

2.1 General

AfluoroscopicdeviceemitsacontinuousbeamofX‐raysinordertoview

anobjectinreal‐time.

PrimaryradiationispresentinthespacebetweentheX‐raysourceandthe

detectorscreen.Theoperatorshouldneverplacehis/herownhandsinthe

beam.

SecondaryradiationorX‐rayscatteriscausedbyX‐raysthatdonotfully

penetratetheobjectplacedintheprimarybeam.X‐rayscatterhas

considerablylessenergythantheprimarybeamandisabsorbedbyother

objectsintheimmediatearea.Theamountofscatterdependsuponthe

powersettingused,thedensityandproximityofthebodyparttothe

beam,andthelengthofexposuretime.

2.2 Radiation Dose and Dose Rate

Radiationreceivedbyeachkilogramofapatient’sbodyiscalleddose.

Dose ratereferstothedosereceivedperunittime.

DistancefromtheX‐raysourcereducesdosetoboththepatientandthe

operator.Forexample,atmaximumoutputthedoseis2.6mGy/minuteat

theimagereceptorand45mGy/minuteattheTubeHousingexitport,or

17timesgreater.ThishighervalueisknownasthemaximumEntrance

ExposureRate(EER).

Scatteredradiationdecreaseswiththesquareofthedistanceinexactlythe

samewayasnotedpreviouslyforX‐raysintheprimarybeam.However,

asthedoserateismuchless,scatterisusuallyexpressedinmR/hour

(1 mR=0.01mGy).

DoseandscatterdatafortheInSight2MiniC‐armisavailablefrom

Hologicuponrequest.

InSight 2 Mini C-arm User Guide

Regulations for X-ray Equipment

MAN-04857 Revision 005 3

2.3 X-ray Shielding

ThescatteredradiationfromtheInSight2MiniC‐armislowcomparedto

manyotherradiologicaldevices,andtherequirementtowearprotective

leadapronsand/orattenuatingglovesisgovernedbyapplicablefacility

policy.Alsomanystates,provinces,countries,andindividualinstitutions

mayrequirepersonsinthesameroomwithanyoperatingfluoroscopic

devicetowearleadaprons.Thestrictobservationofsafeoperating

practicesandtheuseofminimalfluoroscopictimesisthekeytoreducing

userexposure.

3 Regulations for X-ray Equipment

3.1 United States Federal and State Regulations

InSight2MiniC‐armSystemsconformtotheUnitedStatesCodeof

FederalRegulations,21CFR1020.32“PerformanceStandardsforIonizing

RadiationEmittingProducts:FluoroscopicEquipment.”However,

additionalstateregulationsmayapplytoX‐rayproducts.Thismay

requirenotifyingyourstateregulatoryagencyaboutyourinstallation

and/oroperatortrainingandcertification.

Itistheresponsibilityoftheusertocontacttheapplicablestateradiation

controlagencytoverifythatyourinstallationisincompliancewith

regulationsinyourstategoverninginstallationanduseofX‐ray

equipment.

TheInSight2MiniC‐armcomplieswith21CFRSubchapterJ.

TheInSight2MiniC‐armisintendedforspecialsurgicalapplicationsthat

wouldbeprohibitedattheSourcetoSkinDistances(SSD)specifiedin

21CFR1020.32(g)butarepermittedunder21CFR1020.32(g)(2).TheSSD

is10cmminimum.

3.2 IEC Regulations

TheInSight2MiniC‐armcomplieswiththerequirementsofIEC60601‐1.

TheclassificationoftheInSight2MiniC‐armunderthisspecificationis

Class1,TypeB.

TheInSight2MiniC‐armSystemscomplywiththefollowingIEC

standards:

IEC/EN60601‐1IEC/EN60601‐1‐3IEC/EN60601‐2‐28

IEC/EN60601‐1‐2IEC/EN60825‐1IEC/EN60601‐2‐54

InSight 2 Mini C-arm User Guide

EMI

4MAN-04857 Revision 005

3.3 Canadian Regulations

InSight2MiniC‐armSystemscomplywithCSAC22.2No. 601.1

4 EMI

Thisinstrumentisdesignedtobecompatiblewiththeelectromagnetic

environmentsspecifiedinIEC60601‐1‐2andwilloperatesatisfactorily

whenplacedinanenvironmentthatincludesotherequipmentcomplying

withthatstandard.Ifequipmentthatisnotelectromagnetically

compatibleisplacedintotheenvironmentwheretheInSight2MiniC‐arm

isused,theInSight2MiniC‐armImagingSystemorthenon‐compliant

equipmentmaymalfunctionorexhibitotheranomalousbehavior.Consult

theappropriatefieldserviceengineer.

5 Accessories

Thisinstrumentissuppliedwithhardwareandsoftwareaccessoriesthat

areneededforsafeandreliableoperation.Additionalaccessoriesmaybe

usedtoperformoptionalprocedures.Donotuseanyaccessorieswiththis

instrumentotherthanthoseapprovedbyHologic.

InSight 2 Mini C-arm User Guide

InSight 2 System Labels

MAN-04857 Revision 005 5

6 InSight 2 System Labels

6.1 System Main Label

TheSystemMainLabelisonthebackofthebasecabinet.

Figure2SystemMainLabel

InSight 2 Mini C-arm User Guide

InSight 2 System Labels

6MAN-04857 Revision 005

6.2 X-ray System Warning Label

TheX‐raySystemWarningLabelisonthefrontofthebasecabinetbelow

theComputerOn/Standbyswitch.

Figure3X‐raySystemWarning

6.3 Electric Shock Warning Label

TheElectricShockWarningLabelislocatednearthefastenersforpanels

coveringhighvoltagecomponents.

Figure4ElectricShockWarning

6.4 No Pushing Warning Label

TheNoPushingWarningLabelislocatedonthebackofthebasecabinet.

Figure5NoPushingWarning*

*DonotpushthesystemwiththecasterslockedorobstructedandtheC‐armextended.

InSight 2 Mini C-arm User Guide

Symbols

MAN-04857 Revision 005 7

6.5 ISO 7010-M002 Label

Figure6ISO7010‐M002Label

TheISO7010‐M002Label,refertoinstructionmanual/booklet,islocatedon

thebackofthebasecabinet.

7 Symbols

Note OnMEEquipment“Followinstructionsforuse.”

CSAlisteddevice CEmark

Dangerousvoltage Caution

TypeBappliedpart X‐rayfiltration

Warning:Electricity ACVoltage

Timedelayfuse Protectiveearth(ground)

Earth(ground) Equipotentiality

USBconnector Electrostaticsensitivedevice

InSight 2 Mini C-arm User Guide

Symbols

8MAN-04857 Revision 005

Discardelectricalandelectronic

equipmentseparatelyfrom

standardwaste.Send

decommissionedmaterialto

Hologicorcontactyourservice

representative.

ComputerOn/Standbyswitch

Rearwheelsfreetomoveinall

directions

Rearwheelsmoveforwardand

backonly

Locking,general Manufacturer

DateofManufacture Authorizedrepresentativesin

theEuropeanCommunity

Radiationoflaserapparatus X‐raysourceemitting

Store Print

IncreaseordecreasekV/mA Rotateimage

Cyclethroughthenoise

suppressionsettings

Serialnumber

Cataloguenumber Nopushing

ISO7010‐M002,

Refertoinstructionmanual/

booklet.

InSight 2 Mini C-arm User Guide

Safety Hazards

MAN-04857 Revision 005 9

8 Safety Hazards

Thefollowingtableitemizesvarioussafetyhazards.Eachhazardiscross

referencedwiththerespectivecauseandpropercourseofaction.

Table1 SafetyHazards

SafetyHazard Cause CourseofAction

RadiationSafety Thissystemproduces

ionizingradiationand

maybedangerousto

patientsandoperators

unlessthesafetyand

operatinginstructionsin

thismanualarefollowed.

Althoughoperatingthis

systemcanresultinlowscatter

radiationlevels,itis

recommendedthatprotective

X‐rayclothingbewornand

radiationsafetyprecautionsbe

observedwhenoperatingthe

system.

Operatorsshouldavoid

placingtheirhandsoranypart

oftheirbodiesinthepathof

theX‐raybeam.

WhenmakingX‐ray

exposures,placetheanatomy

closetotheImageIntensifier

forthebestimagequalityand

toreduceexposureto

radiation.

Analarmsoundsafterevery

fiveminutesofaccumulated

exposuretime.

ElectricalSafety Electricalcircuits

insidethesystemcan

causeseriousinjuryor

death.

Thissystemoperateson

highvoltages.High

voltagesareatthe

followinglocations:

X‐raytube:75,000Volts.

Safetycovershavebeen

designedforthissystemto

mitigatethehazardscausedby

electricalcircuitsandhigh

voltages.Neverremovethe

coversoroperatethesystem

whilethecoversareoff.Ifany

coverisoff,requestservice

beforeusingthesystem.

Unpluggingthepower

cordfromthewallisthe

onlywaytodisconnect

mainpowerfromthis

system.

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Hologic InSight 2 Mini C-arm User guide

Hologic InSight 2 Mini C-arm User guide

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