GE Healthcare X-ray Bone Densitometer with enCORE v17 Software User Manual

GEHealthcare

X-rayBoneDensitometerwithenCOREv17
software-UserManual

Thismanualsupportsthefollowingproducts:LunariDXA
Series,LunarProdigySeries,LunarDPXSeries

X-rayBoneDensitometerwithenCORE
v17software-UserManual

LU43616EN-2ENRevision19(September

2017)

©2017GEHealthcare

1Safety............................................................................................................25

PrecautionsforStandardOperatingProcedures........................................25

OperatorSafety.............................................................................................26

PersonnelMonitors.....................................................................................26

X-RayandShutterGraphics.......................................................................27

X-RayShutter...............................................................................................27

X-RayPowerSupply....................................................................................27

PatientSafety................................................................................................27

MechanicalSafety.........................................................................................29

Symbols.........................................................................................................29

SampleLabels...............................................................................................30

FailsafeCircuit...............................................................................................35

X-RayShieldingRequirements.....................................................................35

ElectricalSafety.............................................................................................36

PeripheralCongurations...........................................................................36

ScatterRadiation..........................................................................................37

2ProductInformation....................................................................................39

IntendedUse.................................................................................................39

IndicationsforUse........................................................................................39

CautionsforDXADeterminations................................................................41

DeviceDescriptions......................................................................................42

ScannerTableAssembly...............................................................................47

TrainingInformation.....................................................................................50

Classications................................................................................................50

InstallationandOperation............................................................................50

SoftwareInstallation.....................................................................................50

Features.........................................................................................................51

HardwareFeatures.....................................................................................51

SoftwareFeatures.......................................................................................51

QualityAssurance(QA)Features................................................................52

UserInformation.........................................................................................52

Options.........................................................................................................52

3DailyUse.......................................................................................................55

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X-rayBoneDensitometerwithenCOREv17software-UserManual

DailyUse........................................................................................................55

ArchiveExamFiles.......................................................................................55

SafeUseGuidelines......................................................................................56

EmergencyStopButton................................................................................57

TestEmergencyStopButton......................................................................57

CleanScannerTableEnvironment...............................................................57

AnnualMaintenance.....................................................................................57

X-RayTubeandLaserAssemblyMaintenance...........................................58

4QualityAssurance(QA)...............................................................................59

DailyQualityAssuranceProcedure..............................................................59

PrecisionandAccuracy................................................................................60

QAControls....................................................................................................61

QATrendReportingOptions.........................................................................61

MeasuretheSpinePhantom........................................................................63

5MeasurementandAnalysis........................................................................67

Measurement:OverviewandWarnings......................................................67

MeasurementModes..................................................................................68

MeasurementProcedures:Overview..........................................................72

SelectExistingPatientRecord....................................................................72

RecordNewPatientInformation................................................................73

SelectMeasurementSite............................................................................75

AbortMeasurement....................................................................................75

OneVision.....................................................................................................76

QuickView....................................................................................................77

AnalysisProcedures:Overview....................................................................77

SelectImage................................................................................................77

AdjustImage................................................................................................78

Advanced:AdjustROIs................................................................................79

Advanced:AdjustPointTyping...................................................................79

ExamineResults..........................................................................................80

OneScan........................................................................................................85

TurningOneScanOnandOff......................................................................85

OneScanMeasurement..............................................................................85

APSpineMeasurementandAnalysis..........................................................86

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X-rayBoneDensitometerwithenCOREv17software-UserManual

APSpineMeasurement...............................................................................86

APSpineAnalysis........................................................................................89

Femur/DualFemurMeasurementandAnalysis..........................................91

Femur/DualFemurMeasurement..............................................................91

AtypicalFemurFractureMeasurement.....................................................93

Femur/DualFemurAnalysis........................................................................96

ForearmMeasurementandAnalysis.........................................................110

ForearmMeasurement.............................................................................110

ForearmAnalysis.......................................................................................113

TotalBodyMeasurementandAnalysis.....................................................114

TotalBodyMeasurement..........................................................................114

TotalBodyAnalysis...................................................................................116

BodyCompositionMeasurementandAnalysis........................................121

BodyCompositionMeasurement.............................................................122

BodyCompositionAnalysis......................................................................124

Sarcopenia(MuscleLosswithAging).........................................................139

LateralSpineMeasurementandAnalysis.................................................143

LateralSpineMeasurement.....................................................................143

LateralSpineAnalysis...............................................................................146

LVAMorphometryMeasurementandAnalysis.........................................147

LVAMorphometryMeasurement..............................................................147

LVAMorphometryAnalysis.......................................................................149

LVASpineGeometryMeasurementandAnalysis.....................................155

LVASpineGeometryMeasurement..........................................................155

LVASpineGeometryAnalysis...................................................................157

APVAMorphometryMeasurementandAnalysis......................................158

APVAMorphometryMeasurement...........................................................158

APVAMorphometryAnalysis....................................................................160

APVASpineGeometryMeasurementandAnalysis..................................160

APVASpineGeometryMeasurement.......................................................160

APVASpineGeometryAnalysis................................................................162

DualVAMeasurementandAnalysis..........................................................163

PediatricMeasurementandAnalysis........................................................163

PediatricMeasurement.............................................................................164

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X-rayBoneDensitometerwithenCOREv17software-UserManual

PediatricAnalysis......................................................................................165

HandMeasurementandAnalysis..............................................................167

HandMeasurement..................................................................................167

HandAnalysis............................................................................................169

OrthopedicHipMeasurementandAnalysis..............................................170

OrthopedicHipMeasurement..................................................................170

OrthopedicHipAnalysis............................................................................172

OrthopedicKneeMeasurementandAnalysis...........................................174

OrthopedicKneeMeasurement...............................................................174

OrthopedicKneeAnalysis.........................................................................176

SmallAnimalMeasurementandAnalysis.................................................177

SmallAnimalMeasurement......................................................................177

SmallAnimalAnalysis...............................................................................178

CustomAnalysis..........................................................................................180

CustomAnalysisToolbar..........................................................................180

PrecisionCalculator....................................................................................181

PrecisionWizard........................................................................................182

CustomReferencePopulation....................................................................182

CreateaNewReferencePopulation........................................................183

EditaCustomReferencePopulation.......................................................183

DeleteaCustomReferencePopulation...................................................183

ScanCheck...................................................................................................183

ScanCheckChecklist.................................................................................184

AdjustingScanCheckThresholds.............................................................184

6DirectoryManagement.............................................................................187

MoveScans.................................................................................................187

CopyExamFiles..........................................................................................187

EmailImageFiles........................................................................................187

EditPatientsorExams................................................................................188

DeletePatients,Exams,orImages.............................................................188

ChangeImageType....................................................................................189

BatchExamFileOperations.......................................................................189

7Reporting....................................................................................................191

Reports........................................................................................................191

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X-rayBoneDensitometerwithenCOREv17software-UserManual

DXAReports...............................................................................................191

ComposerReports....................................................................................192

ReportCenter..............................................................................................193

CreateaReport.........................................................................................193

SelectAdditionalReports..........................................................................195

ChangeanAssessmentforaReport.......................................................196

CongureRulestoAutomaticallySelectReports....................................197

OptimizingtheReportCenter...................................................................198

StyleSheets.................................................................................................199

CreateaNewStyleSheet.........................................................................200

Subreports...................................................................................................201

CreateaNewSubreport...........................................................................201

AddaSubreporttoaStyleSheet.............................................................201

CongureaSubreporttoAppearOnlyUnderCertainConditions...........202

AssessmentEditor.......................................................................................202

ComposerDatabase...................................................................................205

CreateaNewDatabase............................................................................205

ChangetheActiveDatabase....................................................................206

PracticeManagementTools.......................................................................206

AvailableReports.......................................................................................206

AddaQuery...............................................................................................209

EditaQuery...............................................................................................211

DeleteaQuery...........................................................................................211

BMDSite/RegionFilters.............................................................................211

HistoryCatalog..........................................................................................212

8DatabaseMaintenance.............................................................................213

DatabaseMaintenance..............................................................................213

CompressDatabase...................................................................................213

DeleteDatabase.........................................................................................214

EditDatabase..............................................................................................214

ExportDatabase.........................................................................................216

NewDatabase.............................................................................................216

Archive.........................................................................................................217

RestoreBackup...........................................................................................218

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X-rayBoneDensitometerwithenCOREv17software-UserManual

RebuildDatabase........................................................................................218

ImportEntireDatabases.............................................................................219

ImportDatabaseManually.........................................................................220

SupportedImportOptions..........................................................................220

TaskScheduler............................................................................................221

SQLServerDatabaseInterface..................................................................221

ExternalUSBHardDrive.............................................................................222

9Troubleshooting.........................................................................................225

Troubleshooting..........................................................................................225

10ScreensandToolbars................................................................................227

ScreensandToolbars.................................................................................227

UsingScreens............................................................................................227

UsingToolbars...........................................................................................227

PatientBlock..............................................................................................227

HelpText....................................................................................................227

MainScreen.................................................................................................227

CommonToolbar.......................................................................................229

NewMeasurementScreen.........................................................................229

NewMeasurementToolbar......................................................................230

AnalyzeWhenDoneOption......................................................................230

HomeScannerArm...................................................................................230

ParkScanner.............................................................................................231

AnalyzeScreen............................................................................................231

AnalyzeToolbar........................................................................................231

ResultsTabs...............................................................................................232

DirectoryScreen..........................................................................................233

Search........................................................................................................233

DirectoryToolbar.......................................................................................234

PatientListandExamList.........................................................................234

DatabaseSidebar......................................................................................235

QualityAssuranceScreen...........................................................................235

QualityAssuranceToolbar........................................................................236

SystemStatus............................................................................................236

Options........................................................................................................236

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X-rayBoneDensitometerwithenCOREv17software-UserManual

UserOptions..............................................................................................236

ConnectivityOptions.................................................................................250

ErrorLog......................................................................................................252

11Security.......................................................................................................255

Introduction.................................................................................................255

SecurityFeatures........................................................................................255

AccessControls.........................................................................................255

WindowsUserAccountRequirements....................................................256

ApplicationSecuritySettings....................................................................256

CreateWindowsUserGroups................................................................256

AddUserstoWindowsGroups...............................................................257

CongureUserAccountsforElectronicSignatures................................257

CongureApplicationFunctionsAvailabletoGroups.............................257

Authentication...........................................................................................258

Authorization.............................................................................................259

AuditControls............................................................................................259

MaliciousSoftwareProtection..................................................................261

WorkstationSecurity.................................................................................263

DataProtection.........................................................................................263

SecurityOperations....................................................................................264

NetworkSecurity.......................................................................................264

BusinessContinuity...................................................................................264

MediaAccessControlPoints....................................................................264

RemoteService...........................................................................................265

NetworkInterfaceSpecicationsandRiskManagement........................266

UsingtheGEHCProductSecurityDatabase.............................................268

ASpecications.............................................................................................271

SystemsSpecications...............................................................................271

PhysicalSpecications................................................................................272

OperationalEnvironmentSpecications...................................................273

StorageandTransportEnvironmentSpecications.................................276

SpaceRequirements...................................................................................276

LeakageCurrent..........................................................................................279

InputPower.................................................................................................279

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X-rayBoneDensitometerwithenCOREv17software-UserManual

FuseCapability............................................................................................280

CollimatorSpecications............................................................................280

X-RayGeneratorTechnicalSpecications................................................281

X-RayTubeHeadAssembly.......................................................................289

X-RayTubeTechnicalInformation...........................................................290

AnodeHeating/CoolingCurves................................................................293

FilamentEmissionCharacteristics...........................................................295

X-RayTubeAssemblyHeating/CoolingCurves.......................................296

MaximumScanArea(LongXTransverse)...............................................297

ScatterRadiationDiagrams.......................................................................298

CurrentandTypicalDoseTables................................................................307

IECandUL/CSACertication......................................................................320

ElectromagneticInterference....................................................................320

ElectromagneticCompatibility(EMC)Performance..................................320

EMCEnvironmentandGuidance..............................................................321

DeclarationsofImmunityandEmissions................................................321

MinimumPCRequirements......................................................................323

BReferenceData..........................................................................................329

enCOREReferenceData.............................................................................329

UsingtheReferencePopulationComparison...........................................329

ChoosingReferencePopulationOptions.................................................330

ConguringtheComparisontoReferenceGraph...................................331

ReferenceDataPopulations.......................................................................332

CAdultReferenceData................................................................................339

BoneMineralDensity(BMD).......................................................................339

%YoungAdult..............................................................................................340

%Age-Matched...........................................................................................341

%Age-Matched:WeightAdjustment.......................................................342

%Age-MatchedEthnicityAdjustment......................................................343

%Age-MatchedNationalityReferenceDatabase...................................344

ReferenceGraph:FemaleandMale..........................................................344

ReferenceGraphs:OtherSites...................................................................345

BoneMineralDensityReferencePopulations...........................................346

ComparisontoYoungAdult......................................................................347

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X-rayBoneDensitometerwithenCOREv17software-UserManual

ComparisontoAge-Matched...................................................................347

EffectofPostmenopausalYears..............................................................350

ReferencePopulationDatabase...............................................................350

AgeAdjustment.........................................................................................350

WeightAdjustment...................................................................................358

LateralSpineMorphometryReferenceValues..........................................359

HipAxisLength............................................................................................362

References...................................................................................................363

DPediatricReferenceData..........................................................................371

BoneMineralDensity(BMD).......................................................................371

%Age-Matched...........................................................................................372

%Age-MatchedEthnicityAdjustment......................................................373

%Age-MatchedNationalityReferenceDatabase...................................374

ReferenceGraph:FemaleandMale..........................................................374

ReferenceGraphs:OtherSites...................................................................375

BoneMineralDensityReferencePopulations...........................................376

ComparisontoAge-Matched...................................................................377

ReferencePopulationDatabase...............................................................380

AgeAdjustment.........................................................................................380

GrowthIndices............................................................................................394

References...................................................................................................401

EBodyCompositionReferenceData..........................................................403

Introduction.................................................................................................403

AndroidandGynoidRegionsofInterest....................................................403

ReferencePopulationsthatSupportTotalBodyComposition

ReferenceData...........................................................................................404

BodyCompositionReferenceValuesforFemalePercentFat..................404

BodyCompositionReferenceDataforMalePercentFat.........................406

BodyCompositionPercentFatReferenceData.....................................406

References...................................................................................................409

FUSA(NHANES1999-2004)TotalBodyReferenceData..........................411

Introduction.................................................................................................411

NHANES1999-2004ReferencePopulation...............................................414

GAFFPhantomStudyResults......................................................................457

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Introduction.................................................................................................457

AccuracyofBeakSize.................................................................................457

ReproducibilityofBeakSize........................................................................458

BeakSizeDependenceonPositioning.......................................................458

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X-rayBoneDensitometerwithenCOREv17software-UserManual

ContactInformation

www.gehealthcare.com

Headquarters/Legal
Manufacturer

GEMedicalSystemsUltrasound&
PrimaryCareDiagnostics,LLC.

Streetaddress:

3030OhmedaDr .

Madison,WI53718

USA

Mailingaddress:

P.O.Box7550

Madison,WI53707-7550

USA

Phone:[phone]

China

No.19ChangjiangRoad

Wuxi,Jiangsu,214028

GEMedicalSystemsSCS

283ruedelaMinière

78530BUC,France

France

24Avenuedel'Europe-CS20529

78457VELIZY

Germany

BeethovenStr.239

D-42655Solingen

Germany

Phone:[phone]

Fax:[phone]

Asia/Pacic

4–7–127Asahigaoka

Hino-shi,Tokyo191–8503

P.R.C.

Phone:[phone]

Fax:[phone]

PhysicalManufacturerAddress

GEMEDICALSYSTEMSMONTERREY,
MEXICOS.A.DEC.V.

CalleEspañaNo300,Parque
IndustrialHuinalá,Apocada

Phone:[phone]

Fax:[phone]

Turkey

GEMedicalSystemsTürkiyeLtd.Şti

EsentepeMah.HarmanSok.No:8

34394ŞişliİstanbulTürkiye

Japan

Phone:[phone]

Fax:[phone]

NuevoLeonCP66645MEXICO

GEMedicalSystemsUltrasound&PrimaryCareDiagnostics,LLC,aGeneralElectriccompany,doingbusinessasGEHealthcare/GE
SantéauQuébec.

13

X-rayBoneDensitometerwithenCOREv17software-UserManual

Preface

Thismanualprovidesinstructionsforoperatingthesoftwareandscantable,safetyandmaintenanceinformation,andtechnical
specicationsforyourbonedensitometer.

Theinformationinthismanualissubjecttochangewithoutnotice.Youmayuseorcopythesoftwaredescribedinthismanualonlyin
accordancewiththetermsofyoursoftwarelicense,productwarranty,orservicecontractagreements.

Nopartofthispublicationmaybereproducedforanypurposewhatsoever,storedinaretrievalsystem,ortransmittedinanyformorbyany
means,mechanical,photocopying,recordingorotherwise,withouttheexpresswrittenpermissionofGEHealthcare.

Anyreproduction,photocopyingandrecordinginwholeorpartisprohibited.Anyinformationcontainedhereinshallnotbedisclosedtoany
companyviewedasacompetitortoGEHealthcare.

GEHealthcaremakesnowarrantyofanykindwithregardtothismaterial,andshallnotbeheldliableforerrorscontainedhereinorfor
incidentalorconsequentialdamagesinconnectionwiththefurnishingsoruseofthismanual.

TheinformationcontainedinthemanualiscondentialandproprietarytoGeneralElectric.Thisinformationisprovidedonlytoauthorized
representativesofGEHealthcarecustomerssolelyforthepurposeoffacilitatingtheuseofGEHealthcareproducts.Noinformation
containedhereinmaybedisclosedtoanyunauthorizedpersonforanypurposewhatsoeverwithoutpriorwrittenconsentofGEHealthcare.

Copyright©2007-2017
GEHealthcare,Madison,Wisconsin.Allrightsreserved.
FirstyearofCEMark:2007
Readthismanualthoroughlybeforeusingthesystemorattemptingtoserviceanycomponents.Unauthorizedservicemayvoidsystem

warrantiesorservicecontracts.ConsulttheGEHealthcareCustomerServiceDepartmentbeforeattemptinganyservice:800-437-1171
(U.S.A).

UnitedStatesFederallawrestrictsthisdevicetosalebyorontheorderofalicensedphysician.
Thisisrequiredper21CFR801.109(CodeofFederalRegulations).
LunariDXA,Prodigy,DPX,andCoreScanaretrademarksorregisteredtrademarksofGeneralElectricCompany.Allotherproductandbrand

namesareregisteredtrademarksortrademarksoftheirrespectivecompanies.
Thedevicesforwhichthismanualisusedmayalsobemarketedunderthefollowingnames:

LunariDXA

iDXA
iDXAAdvance
iDXAPro
iDXAForma
LunariDXA

LunarProdigy*Series

ProdigyAdvance
ProdigyAdvanceCompact
ProdigyPrimo
ProdigyPrimoCompact
ProdigyPro
ProdigyProCompact
ProdigyForma
Primo
PrimoCompact
Prodigy
ProdigyCompact

LunarDPX*Series

DPX-NT
DPX-MD+
DPXBravo
DPXDuo
DPXPro
MD+
Bravo
Duo

*

aretrademarksofGeneralElectricCompany.

*

Series

14

X-rayBoneDensitometerwithenCOREv17software-UserManual

Throughoutthismanualtheterm“image”isusedtoindicateaDual-energyX-rayAbsorptiometry(DXA)image,whichisconstructedfrom
low-energyandhigh-energysignals.Dependingontheintendeduse,whenaDXAimageisdisplayedforaquantitativeapplicationsuchas
SpineorFemurBMD,theimageislabeled“ImageNotforDiagnosis.”

ForapplicationssuchasLateralVertebralAssessment(LVA)runningonProdigyoriDXA,theimageislabeled“ImageforSpineMorphometry
AssessmentOnly.”ForapplicationssuchasAtypicalFemurFracture(AFF)runningonProdigyoriDXA,theimageislabeled“Imagefor
atypicalfemurfractureassessmentonly”.

Thesimpleterm“image”isusedthroughoutthemanualforreadability.

15

X-rayBoneDensitometerwithenCOREv17software-UserManual

LicenseandWarrantyInformation

PleasecarefullyreadthefollowingtermsandconditionsbeforeinstallingoroperatingtheGEHealthcareSoftware("Software").Byinstalling
orusingtheSoftwareinYourGEHealthcareproduct,Youindicateyouracceptanceofthesetermsandconditions.IfYoudonotagreewith
thetermsandconditions,donotinstalloroperatetheSoftwareandreturnittoGEHealthcare.

TheSoftwarehasbeenprovidedtoYouforuseonaspecicGEHealthcareproduct.TheSoftwareisprovidedunderthetermsofthis
agreementandislicensedtoYou,notsold.YourrightstousetheSoftwarearesubjecttothetermsandconditionscontainedwithinthis
LicenseAgreementandGEHealthcarereservesanyrightsnotexpresslygrantedtoYou.Thislicenseisnon-exclusiveandanon-transferable
licensetousetheGEHealthcareSoftware.Re-distributionofSoftwareoranydocumentationprovidedtoYoubyGEHealthcareisstrictly
prohibited.

ThisproductincludessomesoftwarecomponentsthatarelicensedundertheGNUGeneralPublicLicense(GPL).SourcecodeforGPL
componentsisavailableuponrequest.

ThetermsandconditionsofthisLicenseAgreementandLimitedSoftwareWarrantyareasfollows:

1.LICENSE.

ThisLicenseallowsYouto:
(a)usetheSoftwareonaproductinaccordancewiththeaccompanyingdocumentation.To"use"theSoftwaremeansthattheSoftware

iseitherloadedinthetemporarymemoryofacomputerorinstalledonanypermanentmemoryormediaofacomputer(e.g.,hard
disk,CD-ROM,opticaldisk,zipdisk,andthelike);

(b)makeone(1)copy,inmachine-readableform,oftheSoftwareasprovidedtoYousolelyforthepurposesofbackup;providedthatsuch
copyincludesthereproductionofanycopyrightnoticeorotherproprietarynoticeappearinginoronsuchSoftware.

2.LICENSERESTRICTIONS.

(a)YOUMAYNOT,EXCEPTASEXPRESSLYPROVIDEDFORINTHISLICENSE:(i)DECOMPILE,DISASSEMBLE,ORREVERSEENGINEERTHE
SOFTWARE(excepttotheextentapplicablelawsspecicallyprohibitsuchrestriction);(ii)COPY,MODIFY,ADAPT,TRANSFER,TRANSLATE,RENT,
LEASE,GRANTASECURITYINTERESTIN,ORLOANTHESOFTWAREORANYPORTIONTHEREOF;(iii)CREATEDERIVATIVEWORKSBASEDUPON
THESOFTWAREORANYPORTIONTHEREOF;OR(iv)REMOVEANYCOPYRIGHTORPROPRIETARYNOTICESORLABELSINORONTHESOFTWARE.

(b)YouunderstandthatGEHealthcaremayupdateorrevisetheSoftware,andinsodoingincurnoobligationtofurnishsuchupdatestoYou
underthisLicense.GEHealthcarehasnoobligationtoimprove,updateorsupporttheSoftwareinthefuture.

(c)IntheeventtheinstrumentorproductdesignatedfortheSoftwareissoldorotherwisetransferredtoathirdparty,thatpartyisnot
authorizedtousetheSoftwareunlesstheyrstpaytoGEHealthcaretheapplicablelicensefeeandagreetothetermsandconditionsofa
SoftwareLicenseAgreement.UpontransferoftheSoftwareoranycopythereof,theLicensegrantedhereundershallterminateimmediately.

3.TERMANDTERMINA TION.

ThisLicenseiseffectiveuntilterminated.ThisLicensewillterminateimmediatelywithoutnoticefromGEHealthcareorjudicialresolutionif
YoufailtocomplywithanyprovisionoftheLicense.UponanyterminationofthisLicense,YouagreetoreturnordestroytheSoftware,all
accompanyingwrittenmaterialsandallcopiesthereofinanyform.Section5willsurviveanytermination.

4.EXPORTLAW.

YouagreethatneithertheSoftwarenoranydirectproductthereofisbeingorwillbeshipped,transferredorre-exported,directlyorindirectly
intoanycountryprohibitedunderUnitedStateslaworregulationspromulgatedthereunder.

5.WARRANTY.

GEHealthcarewarrantsthat,tothebestofourknowledge,thesoftwareprovidedwiththisLicensewillperformasdescribedinthe
product'soperator'smanualandthetechnicalspecicationforthisSoftware.Thislimitedwarrantyiscontingentuponproperuseofthe
SoftwareanddoesnotcoveranySoftwarewhichhasbeenmodied,subjectedtomaliciouslogic,unusualphysicalorelectricalstress,or
usedoncomputerequipmentnotspeciedbyGEHealthcare.

GEHealthcaredoesnotwarrantthatthefunctionscontainedinthisSoftwarewillmeetyourrequirements,orthattheoperationofthe
Softwarewillbeuninterruptedorerror-free.StatementsmadeaboutthisSoftwaredonotconstitutewarrantiesandshallnotbereliedupon
byYouindecidingwhethertopurchasetheGEHealthcareproductorusetheSoftware.INNOEVENTSHALLGEHealthcareBELIABLETO
YOUFORANYDAMAGESARISINGOUTOFTHEUSEORINABILITYTOUSESUCHSOFTWARE.

THESOLEANDEXCLUSIVEREMEDYINTHEEVENTOFDEFECTISEXPRESSLYLIMITEDTOTHEREPLACEMENTOFTHESOFTWAREPROVIDED.IF
FAILUREOFTHESOFTWAREHASRESULTEDFROMACCIDENTORABUSE,GEHEALTHCARESHALLHAVENORESPONSIBILITYTOREPLACE
THESOFTWARE.

GEHealthcarewillconsiderthiswarrantytobevoidifYoufailtocomplywiththetermsintheSoftwareLicenseAgreement.

16

X-rayBoneDensitometerwithenCOREv17software-UserManual

6.TITLE.

Title,ownershiprights,andintellectualpropertyrightsintheSoftwareshallremainwithGEHealthcare.ThisSoftwareisprotectedbythe
copyrightlawsandtreaties.

7.MISCELLANEOUS.

ThisAgreementrepresentsthecompleteagreementconcerningthisLicenseandmaybeamendedonlybyawritingexecutedbyboth
parties.TheLicenseisgovernedbythelawsoftheStateofWisconsin,U.S.A.withoutregardtoitsconictoflawsprinciples.Ifanyprovision
ofthisAgreementisheldbyacourtofcompetentjurisdictiontobeunenforceable,thatprovisionshallbeenforcedtothemaximumextent
permissibleand/orreformedonlytotheextentnecessarytomakeitenforceable,andtheremainingprovisionsofthisAgreementwillnot
beaffectedorimpairedinanyway.IfanylegalactionorproceedingisbroughtfortheenforcementofthisAgreement,orbecauseof
anyallegeddispute,breach,defaultormisrepresentationinconnectionwithanyoftheprovisionsofthisAgreement,thesuccessfulor
prevailingpartyshallbeentitledtorecoverreasonableattorneys'feesandothercostsincurredinsuchactionorproceeding,inadditionto
anyotherrelieftowhichsuchpartymaybeentitled.

17

X-rayBoneDensitometerwithenCOREv17software-UserManual

Registration

Governmenthealthdepartmentscanrequiremedicalfacilitiestoregisterdiagnosticx-rayequipment.Manymunicipalandstatehealth
agenciesrequiremedicalhealthfacilitiestoemploycertiedradiologictechnologiststooperatediagnosticx-raydevices.Contactyourlocal
regulatoryauthoritiesorGErepresentativeforregistrationguidelinesandregulationcompliance.

18

X-rayBoneDensitometerwithenCOREv17software-UserManual

DisposalofMaterials

Thescannercontainslead(forx-rayshielding)andoneofthefollowing:sodiumiodide,cadmiumtelluride,LutetiumYttriumSilicon
Dioxide(L YSO),orcadmiumzinctelluride(usedforx-raydetection).

WEEELabel

Thissymbolindicatesthatthewasteofelectricalandelectronicequipmentmustnotbedisposedasunsortedmunicipalwasteandmustbe
collectedseparately.Pleasecontactanauthorizedrepresentativeofthemanufacturerforinformationconcerningthedecommissioningof
yourequipment.

IfyoucontractwithGEHealthcareforthedisposalofyourscanner,GEHealthcarewillproperlydisposeofthesematerials.Ifyouchoose
todisposeofyourscanneryourself,bothsubstancesmustbedisposedofinaccordancewithlocalregulations.ContactyourlocalGE
representativeforWEEEinformation.

19

X-rayBoneDensitometerwithenCOREv17software-UserManual

FDACertiedComponents

LunariDXASeries

ThefollowingtablegivescomponentscertiedtotheFDAforusewithLunariDXAseriesscanners.Thetablesareupdatedperiodically.
ContactGEHealthcareforacurrentlistingofcompatiblecomponents.

ComponentDescriptionGEModel

Tubehead
assembly

GEMedicalSystemsUltrasound&
PrimaryCareDiagnostics,LLCiDXA

40782

SeriesX-RayTubeHeadAssembly

X-raycontrollerGEMedicalSystemsUltrasound&

41718
PrimaryCareDiagnostics,LLCiDXA
SeriesX-rayController

CollimatorGEMedicalSystemsUltrasound&

42129
PrimaryCareDiagnostics,LLCiDXA
SeriesCollimatorAssembly

PRODIGYAdvance301000andhigher,PRODIGY301000andhigher

ThefollowingtablesgivecomponentscertiedtotheFDAforusewithProdigyseriesscanners.Thetablesareupdatedperiodically.Contact
GEHealthcareforacurrentlistingofcompatiblecomponents.

ComponentDescriptionGEModel

X-raycontrollerGEMedicalSystemsUltrasound&

41170

PrimaryCareDiagnostics,LLCsingle
boardcontroller

Highvoltagepower
supplies

GEMedicalSystemsUltrasound&
PrimaryCareDiagnostics,LLCModel:
2907

7681

7681

GEMedicalSystemsUltrasound
&PrimaryCareDiagnostics,LLC
Model:SBD40PN280X2890or
SBD40PN280X4445

Tubehead
assembly

GEMedicalSystemsUltrasound&
PrimaryCareDiagnostics,LLCX-Ray

8743or45645

TubeHeadAssembly

CollimatorGEMedicalSystemsUltrasound

8915

&PrimaryCareDiagnostics,LLC
PRODIGYCollimatorAssembly

20

X-rayBoneDensitometerwithenCOREv17software-UserManual

PRODIGYAdvance40000-141999,PRODIGY13000-13999

ComponentDescriptionGEModel

X-raycontrollerGEMedicalSystemsUltrasound&

PrimaryCareDiagnostics,LLCsingle
boardcontroller

Highvoltagepower
supplies

GEMedicalSystemsUltrasound&
PrimaryCareDiagnostics,LLCModel
2907

GEMedicalSystemsUltrasound
&PrimaryCareDiagnostics,LLC
ModelSBD40PN280X2890or
SBD40PN280X4445

Tubehead
assembly

GEMedicalSystemsUltrasound&
PrimaryCareDiagnostics,LLCX-Ray
TubeHeadAssembly

CollimatorGEMedicalSystemsUltrasound&

PrimaryCareDiagnostics,LLCProdigy
CollimatorAssembly

7635

7681

7681

8743or45645

8915

DPX-NT/PRO/MD+/72000andhigher/90000andhigher

ThefollowinggivecomponentscertiedtotheFDAforusewithDPX-NT/PRO/MD+scanners.Thetablesareupdatedperiodically.Contact
GEHealthcareforacurrentlistingofcompatiblecomponents.

ComponentDescriptionGEModel

X-raycontrollerGEMedicalSystemsUltrasound&

7634
PrimaryCareDiagnostics,LLCsingle
boardcontroller

Highvoltagepower
supplies

GEMedicalSystemsUltrasound&
PrimaryCareDiagnostics,LLCModel
2907

7681

7681

GEMedicalSystemsUltrasound
&PrimaryCareDiagnostics,LLC
ModelSBD40PN280X2890or
SBD40PN280X4445

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X-rayBoneDensitometerwithenCOREv17software-UserManual

ComponentDescriptionGEModel

DPXDuo,DPXBravo

TubeheadassemblyGEMedicalSystemsUltrasound&

8548or45649
PrimaryCareDiagnostics,LLCX-Ray
TubeHeadAssembly

CollimatorGEMedicalSystemsUltrasound&

7767
PrimaryCareDiagnostics,LLCDEXA
CollimatorAssembly

ComponentDescriptionGEModel

X-raycontrollerGEMedicalSystemsUltrasound&Primary

CareDiagnostics,LLCsingleboardcontroller

Highvoltagepower
supplies

GEMedicalSystemsUltrasound&
PrimaryCareDiagnostics,LLCModel
SBD40PN280X2890orSBD40PN280X4445

41500

7681

TubeheadassemblyGEMedicalSystemsUltrasound&Primary

CareDiagnostics,LLCX-RayTubeHead
Assembly

CollimatorGEMedicalSystemsUltrasound&Primary

CareDiagnostics,LLCDEXACollimator
Assembly

8548or45649

7767

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X-rayBoneDensitometerwithenCOREv17software-UserManual

OperatorProle

TheintendedusersoftheDXAscanneraremedicalprofessionalswithknowledgeandexperiencerequiredtoworkwithx-rayequipment.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Safety

PrecautionsforStandardOperatingProcedures

Useofcontrolsoradjustmentsorperformanceoftheproceduresotherthan
thosespeciedhereinmayresultinhazardous(laserorx-ray)radiation
exposure.

1.Donotattempttooperatethex-raybonedensitometerwithoutrstreading
thismanual.

2.Donotremovetheassemblypanelsorattemptanyrepairswithoutprior
instructionsfromauthorizedpersonnel.

3.PerformtheQualityAssuranceprocedureeachmorning.Ifanytestfails,check
thepositionofthecalibrationblockandreruntheQAprocedure.Ifatestfails
again,contactGESupport.Also,callGESupportifmorethantwofailuresoccurin
aone-weekperiod.Iftheroomtemperaturechangesmorethan5°Cduringthe
day,performanotherdailyQA.

4.Ifthepatientisormightbepregnant,alwayscontactthepatient'sphysician
beforeperformingascan.

5.Remaininvisualcontactwiththepatientwhileascanisinprogress.Ensurethat
thepatientdoesnotmoveduringthemeasurement.Minimizetheamountoftime
thepatientliesatonthescantable.

6.Restrictaccesstotheroomtoauthorizedpersonnel.

7.Donotattempttoserviceanyofthesystem'selectricalcomponentswhilethe
x-raybonedensitometeristurnedON.Highvoltageisusedtoproducex-rays.

8.Radiationsafetyinformationislocatedwithinthismanualyoureceivedwithyour
system.Reviewthisinformationbeforeoperation.

9.Tostopthex-raybonedensitometerinanemergency,presstheemergency
stopbuttononthescanarm.DONOTusetheemergencystopbuttontoroutinely
abortascan.

10.Immediatelyremoveanyuidsspilledonthepadoranysurfaceoftable.

11.Allsurfacesshouldbecleanedtomeetsite'sguidelinesforhandlingbloodand
bodyuids.Padmaterialmaybedamagedbycertainchemicals.Useappropriate
hospitalgradedisinfectant(forexample:Cidex®,HBQuat,Precise®,PDI)followed
bymilddetergent.

12.Donotgeneratex-raysthroughtheuseofremoteapplications.

13.Protectthecomputeragainstmaliciouslogicandunauthorizednetwork
access.Onlyallowauthorizeduseraccess.Preventvirusattacksbyusing

1

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Safety

OperatorSafety

rewalls,anti-virussoftwareandsoftwarepatchupdates.ContactyourlocalGE
representativeformoreinformation.

14.DPXDuo:Extendthestepthefulldistancetoprovidemaximumsurfaceareafor
thepatienttogetonandoffthetablewithoutriskofinjury.

15.DPXDuo:Donotplaceanexcessiveloadonfootreststirrup(maximumload
is60pounds),drawers(maximumloadis100pounds),orlegextensiontable
(maximumloadis300pounds).

16.DPXDuo:Donotsitonlegextensiontable.

BecausetheDXAhastwocontrolpoints(PCandfrontpanel),theoperatorshould
visuallyensurethatnopersonisnearmovingparts,pinchpoints,orthex-raybeam
beforestartingascan.Theoperatormustunderstandtheuseoftheemergencystop
buttononthefrontpanel.SeeEmergencyStopButton(57).

DPXNT/MD,DPXDuo/Bravo,andProdigyscanners:Toavoidscatterradiation,the
operatorshouldremainatleast3feet(1meter)awayfromthecenterofthescanner.

iDXAscanners:Toavoidscatterradiation,theoperatorshouldremainatleast6feet(2
meters)awayfromthecenterofthescanner.

Maximizingthedistancefromthepatientwilldecreasetheoperator’sexposure
toscatterradiation;however,theoperatorshouldmaintainvisualorvoicecontact
withthepatientatalltimes.Optionalprotectiveequipmentwillfurtherreducethe
operator’sexposuretoscatterradiation.

PersonnelMonitors

Personnelmonitorsarenotnecessarytooperatethescanner.
Itisnotlikelythatyoucanreceivemorethan25%ofthemaximumpermissiblex-ray

dosefromthescanner.However,somefacilitieschoosetousepersonnelmonitors.
Refertoyourcity,countyorstateHealthDepartmentorRadiationSafetyOfcer
foryourfacility'spolicy.

Filmbadgesandthermalluminescentdosimeter(TLD)badgesareobtainedfroma
supplieraccreditedbytheNationalVoluntaryLaboratoryAccreditationProgramfor
personneldosimetryprocessing.

ThefollowingisasamplesituationforaclinicmeasuringanAPspineandDualFemur
on5subjectsperdaywithanexposurerateof0.18mR/hratadistanceof2meters
estimatedfromtheiDXAisodosecurves.

SampleCalculationforEstimatedExposureperYearfromScatterwithiDXA
Densitometer

ScanType

APSpine
DualFemurStandard

2.5mAScanTimeperDay(sec)

2.5mAScanTimeperDay(hours)

Mode

Standard

Average
Scans/Day

5
5535535

Scan
Time/Day
(sec/day)

260260

Equivalent

2.5mAScan
Time/day
(sec/day)

795

0.221

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Safety

X-RayandShutterGraphics

ScanType

2.5mAScanTimeperWeek(hours)

2.5mAScanTimeperYear(hours)

2.5mAExposurefromIsodosePlots(mR/hr)

TotalExposurefor1Year(mR)
TotalAbsorbedDosefor1Year(mRad)0.92Rad/R

DuringameasurementorQualityAssuranceprocedure,x-rayandshuttergraphics
areshownonthecomputermonitor .Thegraphicsaregreentoindicatex-raysareoff
andtheshutterisclosed,andyellowtoindicatex-raysareonandtheshutterisopen.

X-raysoffandshutterclosed(green)

Mode

Average
Scans/Day

Scan
Time/Day
(sec/day)

Equivalent

2.5mAScan
Time/day
(sec/day)

1.11

57.5

0.18

10.3

9.5

X-RayShutter

X-RayPowerSupply

PatientSafety

PinchPoints

X-raysonandshutteropen(yellow)

WhenpowertothescannerisinterruptedduringameasurementorQualityAssurance
procedure,theshutterclosesandthex-raytubestopsgeneratingx-radiation.

Thex-raytubeassemblyuseshighvoltagetogeneratex-rays.DONOTtouch
internalcomponents.DONOTattempttoserviceinternalcomponents.

Thislabelidentiesthelocationofpossiblepinchpoints.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Safety

Whenthescannerarmisinmotion,makesurepossiblepinchpointareasareclearat
alltimes.Patientlimbsmustremaininsidetheboundariesofthetabletop.Apinch
pointispossiblebetweenthescannerarmandtable.

LaserSafety

DONOTSTAREINTOTHELASERBEAMduringpatientpositioningandQuality

Assuranceprocedures.Thislabelislocatedunderthescannerarmandshowsthe
locationofthelaseraperture:

RadiationSafety

Thelaserapertureislocatedontheundersideofthescannerarm,facingthepatient.
Keepthelaserapertureawayfromthepatient’seyesduringpatientpositioning.

X-rayexposure:Thesystemmakesradiationwhenelectricvoltageissuppliedto,and
currentowsthrough,thex-raytube.Duringameasurement,theshutteropenstolet
abeamofradiationpassthroughthescannertableandpatient.

ForiDXAsystems,thenominalradiationeldatthescannertabletopis18.4mmx

3.3mm.

ForProdigysystems,thenominalradiationeldatthescannertabletopis19.5mmx

3.4mm.

ForDPXsystems,thenominalradiationeldatthescannertabletopis2mm.

Leadoxideshieldingsurroundsthex-raytubeinsertinsidethetubehousingassembly
andreducesradiationlevelsaroundthescannertable.

Leakageradiation:<0.4mR/hrat1meter .

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X-rayBoneDensitometerwithenCOREv17software-UserManual

SkinEntranceDose

MechanicalSafety

Safety

RefertoCurrentandTypicalDoseTables(307)forirradiationtimesandskinentrance
doses.AVictoreenmodel530PrecisionElectrometer/DosemeterwithaModel660-5
IonChamberwasusedtomeasuretheX-rayentrancedose.

Thescannerarmmovesdowntheentirelengthofthescannertable.Makesurethe
patientdoesnotinterferewiththemovementofthescannerarmtopreventpossible
injury.Inaddition,makesurethattherearenoobjectsbehindthescannertablethat
mightobstructmovementofthescannerarm.

iDXAscanners:Weightappliedtothescantablebedmustnotexceed204kg(450lb).
DPXNT/MD+scanners:Weightappliedtothescantablebedmustnotexceed136

kg(300lb).
DPXDuo/BravoandProdigyscanners:Weightappliedtothescantablebedor

footstep(DPXDuoonly)mustnotexceed159kg(350lb).

Symbols

Symbol

or

Name

ElectronicInstructions
forUse

EmergencyStop

FocalPointSymbolfromEN60417-1,5327

FunctionalEarthShowslocationofFunctionalEarthterminal

Description

SymbolindicatingthattheInstructionsforUse
aresuppliedinelectronicform

Showsthelocationoftheemergencystop
button

LaserOn

PermanentFiltrationSymbolfromEN60417-1,5381

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X-rayBoneDensitometerwithenCOREv17software-UserManual

ShowsthelocationoftheLaserOnindicator.

Safety

Symbol

Name

PowerOffShowstheswitchpositionforPowerOff

PowerOn

ProtectiveEarthShowslocationofProtectiveEarthterminal

RefertoInstruction
Manual

ShutterOpenShowsthelocationoftheShutterOpen

TubeInsertSymbolfromEN60417-1,5337

TypeBEquipment

Description

ShowsthelocationofthePowerOnindicator
andtheswitchpositionforPowerOn

AlertstheuserthattheUserManualcontains
importantsafetyinformation

indicator

ShowsthatthescannerhasTypeBprotection
againstelectricalshock

SampleLabels

Warning

X-rayOn

X-raySource

Showsimportantsafetywarnings,suchasthe
locationofpinchpoints

ShowsthelocationoftheX-rayOnindicator

SymbolfromEN60417-1,5338

Actuallabelappearancemayvaryfromthesamplesdisplayed
inthissection.

Forlabelsshowingcerticationto21USCFRSubchapterJ,themonthinthe
Manufacturedeldistranslatedbelow.

EnglishTranslationEnglishTranslation

January

February

July

August

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X-rayBoneDensitometerwithenCOREv17software-UserManual