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

24

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

EnglishTranslationEnglishTranslation

MarchSeptember

AprilOctober

Safety

May

June

LaserCautionandIonizingRadiationLabel

November

December

ThislabelshowsthatthescannerusesaClassIIlaserandproducesionizingradiation
(x-rays).

LaserRadiation.Donotstareintobeam.Class2LaserProduct.Laserwavelengthis
655nm.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Safety

TubeHousingAssemblyLabel

Thislabelgivestubeassemblyandx-raysourcecharacteristicsinformation.Itis
locatedonthetubeheadassembly(insidethescanner)andonthefootpanelofthe
scanner.

SystemLabel

Thislabelgivessysteminputpowerrequirementsandcomplianceinformation.Itis
locatedonthefootpanelofscanners.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

TheRefertoInstructionManualsymbolindicatesaneedtoreadaccompanying
documents.

ThePersonsymbolreferstoTypeBappliedparts(anyexposedsurfaceofthescanner
tableassembly)fordegreeofelectricshockprotectionperEN60601-1.

TheFansymboldenotesthationizingradiationisgenerated.
TheGOSTsymbolshowscompliancewithRussianregulations.
TheCEmarkshowscompliancewiththeMedicalDeviceDirective93/42/EEC.
TheETLmarkshowscompliancetoANSI/AAMIES60601-1andCAN/CSAC22.2No.

60601-1.
TheEACsymbolshowsthatthisproductpassedallconformityassessment(approval)

proceduresthatcorrespondtotherequirementsofapplicabletechnicalregulations
oftheEurasianCustomsUnion.

TheWasteReceptaclemarkindicatesthatthewasteofelectricalandelectronic
equipmentmustnotbedisposedasunsortedmunicipalwasteandmustbecollected
separately.Pleasecontactanauthorizedrepresentativeofthemanufacturerfor
informationconcerningthedecommissioningofyourequipment.

Safety

HighVoltagePowerSupplyLabel

Thislabelgiveshighvoltagepowersupply(x-raygenerator)information.Itislocated
onthehighvoltagepowersupply(insidethescanner)andonthefootpanelofthe
scanner.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Safety

X-rayControllerLabel

Thislabelshowsx-raycontrollercompliance.Itislocatednearthex-raycontroller
(insidethescanner)andonthefootpanelofthescanner.

CollimatorAssembly

Thislabelgivescollimatorassemblyinformation.Itislocatedonthecollimator(inside
thescanner)andonthefootpanelofthescanner.

WarningandRadiationSymbolLabel

Thislabelshowsthatthesystemusesionizingradiation.Itisfoundonlyonsystems
deliveredintheUnitedStates.Alwaysobeyinstructionsforsafeoperation.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

GroundingReliabilityLabel

Thislabelstatesthatgroundingreliabilitycanbemaintainedonlywhenusinga
"HospitalGrade"or"HospitalOnly"receptacle.Itisfoundonallpowercordsof
systemsdeliveredintheUnitedStates.

Safety

UniqueDeviceIdenticationLabel

Everymedicaldevicehasauniquemarkingforidentication.TheUDImarking
appearsonthedevicelabeling.

FailsafeCircuit

Duringoperation,thescannerisconstantlymonitoredfordiagnosticfailures.Ifa
diagnosticfailureoccurs,thefailsafecircuitstopspowertothescannermotorsand
disablesthex-raysystem.Amessageisshownonthecomputerthatdescribesthe
failure.CallGESupportoryourGEdistributorandprovidethefailuredescription.

X-RayShieldingRequirements

InstallaCaution:X-Radiationsignintheareaorroomwherethesystemisoperated.
Becauseoflowleakagelevelsofradiationfromthex-raytubeassembly,additional
shieldinginthewalls,oor,orceilingisnotnecessary.However,callyourstateorlocal
healthandradiationsafetydepartmentsforshieldingrequirements.

ThisisonlyanexampleofaUDImarking.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Safety

ElectricalSafety

PeripheralCongurations

InsulatepatientfromanymetalassociatedwiththeDPXDuobyusinga
non-conductivematerialduringcauterizationorsimilartreatmentstoavoid
shockorburns.

Donotplugadditionaloutletstripsorextensioncordsintopowersource
connectedtoscanner.

Toavoidriskofelectricshock,thisequipmentmustbeconnectedonlytoa
supplymainswithprotectiveearth.Scannerpowercordmustbeconnected
directlytothewalloutletortoaredundantlygroundedUPS.Neverpowerthe
scannerviaanoutletstrip.

Thecorrectconnectionofthecomputerandallperipheralsisnecessaryto
maintainelectricalsafety.Thesignalcableofthescannerisintendedonlyfor
connectiontoanapprovedcomputer .CallGESupportoryourGEdistributor
beforeaddingperipherals.

StandardRoomConguration

SmallRoomConguration

Operatorshallnottouchpatientandcomputerorperipheralssimultaneously.

Failuretouseoutletstripsproperlycancausemedicalelectricalsystem
leakagecurrentsinexcessof100microamperes.Formoreinformationon
medicalelectricalsystems,refertoIEC60601-1.

Thecomputer,peripherals,andallotherequipmentmustbelocatedmorethan1.5m
fromthescanner.Ifanoutletstripisusedtopowerthecomputer,itmustbemounted
offtheoorsothatitdoesnottouchotherequipment.

Amodemand/ornetworkconnectioncanbemadeatanytimeifyouareusingthe
standardroomconguration.

Youmustpowerthecomputer,peripherals,andallotherequipmentwithanisolating
transformeriftheroomistoosmalltomaintainatleast1.5mofseparationbetween
thescannerandallotherequipment.

TheisolationtransformersuppliedbyGEHealthcarehasamaximumoutput
of400/500VA.Becausethetransformerincludesamultiplesocketoutlet,only
system-relatedequipmentshallbepoweredbytheisolationtransformer.

Amodemand/ornetworkconnectioncanonlybemadeinthesmallroom
congurationifallexposedmetalsurfacesofthecomputerandperipheralsareoutof
thepatientenvironment.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Safety

ScatterRadiation

RefertoScatterRadiationDiagrams(298)toseeisodosediagramsofscannerscatter
radiation.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

Safety

38

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

IntendedUse

Thebonedensitometerisdesignedtoestimatethebonemineraldensityandbody
composition(leanandfattissuemass)ofpatientswhenmedicallyindicatedbytheir
physicians.

Thismanualprovidesinstructionsforoperatingthesoftwareandscantable,system
information,andmaintenanceinformation.

UnitedStatesFederalLawrestrictsthisdevicetothesale,distribution,andusebyor
ontheorderofaphysician(USAonly).

VariablesAffectingScanResults

Scanresultscanbeaffectedbyoperatortechniqueandpatientvariability.
Operatortechniquereferstopatientpositioningandscananalysis.Tominimize

techniquevariables:

2

●Establishconsistentpositioningandscananalysisroutinesbyusinganatomical

landmarkswhenpositioningpatients.

●Duringanalysis,manipulaterawscandataonlywhenabsolutelynecessary.

Patientvariabilityreferstochangesinthepatient'smedicalhistory,metabolism,and
diet.Italsoreferstodiagnosticproceduresthatinvolveradionuclideuptakeand
medicaltreatment,andthepresenceofexternalradiation(particularlytheuseof
otherradiation-generatingdevicesinthevicinityofthesystem).Tominimizepatient
variability:

●Thoroughlyfamiliarizeyourselfwiththepatient'shistory.

●Installthescannerinanenvironmenteffectivelyshieldedfromothersourcesof

externalradiation.

IndicationsforUse

Thex-raybonedensitometersupportsthefollowingindicationsforuse:
Providesanestimateofbonemineraldensityatvariousanatomicalsites(Spine,

Femur,TotalBody,andForearm).Thesevaluescanthenbecomparedtoanadult
referencepopulationatthesolediscretionofthephysician.

Providesanassessmentofrelativefractureriskbasedonthepatient'sT-scorevalue
usingthecategoriesoffractureriskdenedbytheWorldHealthOrganization(WHO).

Providesanassessmentof10-yearfractureriskusingWHOFRAXmodel.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

Providesastandardizedbonedensityreportusingdatafromthedensitometerand
physician-generatedassessmentsbasedonthepatient'sdemographics,whichcan
assistthephysicianincommunicatingscanresultstothepatientandthepatient's
referringphysician.

OptionalHandBMDsoftwareestimatestheBMDatthehand.
OptionalDual-EnergyVertebralAssessmentsoftwareprovidesanx-rayimageofthe

spineforqualitativevisualassessmentinordertoidentifyvertebraldeformationsand
estimatevertebralheights(morphometry).

OptionalOrthopedicsoftwareestimatesperiprostheticBMDofanorthopedichip
orkneeimplant(pre-andpost-surgery).

DPXonly:OptionalPediatricsoftwareoptionexpandstherangeofbonedensitometry
referencedatatoincludeages5through19years.Thesoftwareprovidesa
comparisonofmeasurevariablesobtainedbydualenergyx-rayabsorptiometryto
adatabaseofreferencevalues.Thesedatacanbeusedforcomparativepurposes
atthesolediscretionofthephysician.

OptionalCompletePediatricsoftwareoptionmeasuresbonemineralcontent(BMC),
bonemineraldensity(BMD)andbodycomposition(leanbodymassandfatmass)
inpatientsfrombirthto20yearsofage.Thesoftwareprovidesacomparisonof
measuredvariablesobtainedbydualenergyx-rayabsorptiometrytoadatabase
ofreferencevaluesforpatients5-19yearsofage.Thesedatacanbeusedfor
comparativepurposesatthesolediscretionofthephysician.Thesoftwaredoes
notprovideareferencepopulationforcomparativepurposesforpatientsyounger
than5yearsofage.

OptionalBodyCompositionsoftwaremeasurestheregionalandwholebodybone
mineraldensity(BMD),leanandfattissuemass,andcalculatesotherderivativevalues
whichcanbedisplayedinuser-denedstatisticalformatsandtrends,andcompared
toreferencepopulationsatthesolediscretionofthehealthcareprofessional.Someof
thediseases/conditionsforwhichbodycompositionvaluesareusefulincludechronic
renalfailure,anorexianervosa,obesity,AIDS/HIV,andcysticbrosis.

TheMirrorImagefunctionusedontheGELunarDXAbonedensitometerscanbe
usedtoestimatethetotalbodycompositionandbonemineraldensity(BMD)when
regionsofthebodyareoutsideofthescanwindowbyusingscanneddatafromthe
correspondingregion(s)ontheoppositehalfofthebody.

OptionalCoreScan

*

softwareestimatestheVisceralAdiposeTissue(VAT)content
withintheandroidregioninamaleorfemalepopulationbetweentheagesof18
and90withaBMIbetween18.5and40,excludingpregnantwomen.Thecontent
thatisestimatedistheVATMassandVATVolume.Thevaluescanbedisplayedin
user-denedstatisticalformatsandtrends.Someofthediseases/conditionsforwhich
VATestimationcanbeusefulincludehypertension,impairedfastingglucose,impaired
glucosetolerance,diabetesmellitus,dyslipidemiaandmetabolicsyndrome.

OptionaltotalbodycompositionsoftwareestimatestheRestingMetabolicRate(RMR)
inthemaleorfemalepopulationage18andolder.Thedatacanbedisplayedin
user-denedstatisticalformatsandtrends.

OptionaltotalbodycompositionsoftwareestimatestheRelativeSkeletalMuscleIndex
(RSMI)inthemaleorfemalepopulationage18andolder .Thedatacanbedisplayedin
user-denedstatisticalformatsandtrends.

OptionalAdvancedHipAssessment(AHA)softwareprovidesameasurementofhip
axislength(HAL)andameanvalueofHALforCaucasianandAsianfemaleson

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X-rayBoneDensitometerwithenCOREv17software-UserManual

femurimages.Italsocalculateshipgeometryvaluesusedtoevaluatethestructural
propertiesofthehip.

TheDPX-Duohasspecialmechanicalfeaturesincludingstirrups,storagedrawers,and
patientsteptoallowuseasanexamtablewhenbonedensitometryisdisabledand
thescanarmisrotatedandlockedparalleltothetable.

OptionalAtypicalFemurFracture(AFF)softwareusesfemurimagestovisualizefocal
reactionorthickeningalongthelateralcortexofthefemoralshaftwhichmaybe
accompaniedbyatransverseradiolucentline.Thissoftwareprovidesmeasurements
ofthelateralandmedialcortexwidthandquantiesfocalthickeningofthelateral
cortexalongthefemoralshaft.Thebeakingindexcanbedisplayedandtrended
acrossserialscans.

Optionalsarcopeniasoftwarecalculatesvaluesbasedonpublisheddenitionsand
thresholdsusingmeasuredappendicularleanmassincombinationwithpatient
demographicsandenteredvaluesofmusclestrengthandphysicalperformance.
Thesevaluesmaybeusefultohealthcareprofessionalsintheirmanagementof
sarcopenia.

CautionsforDXADeterminations

ProductInformation

Youshouldbeawareofthefollowingfactorswhichmayaffecttheclinicalaccuracyof
DXAspineestimates:markeddistortionsofskeletalarchitecture(e.g.,osteophytes,
degenerativediscdisease,spinalarthritis,spondylolisthesis,kyphoscoliosis,and
vertebralfractures)andsignicantcalciumdepositsintheaortacanfalselyelevate
spinebonemineralvalues.Regionsthatcontainthesedystrophiccalcicationscanbe
excludedfromthescananalysisinsomecases.Thescannercanbeusedtomonitor
changesinbonemineralovertimeinpatientswiththesedisorders,butcautionmust
betakenininterpretation.UseDXAestimatesasanaidtoothermethodsinthe
evaluationofpatientbonemineralstatusintheclinicalsetting.

Inaddition,spineestimateswillbedifculttointerpretforpatientswithorthopedic
metaldevicesandprevioussurgicalinterventions,suchasbonegrafts.Radiographic
contrastmaterialandradiopharmaceuticalsusedformyelograms,bariumenemas,
andotherdiagnostictestspreventaccurateestimates.Bariumclearsthebodywithin
afewdays,buttheoil-baseddyesusedinmyelogramsseveralyearsagomayremain
withinthebodyforyears.Athree-daywaitingperiodissufcienttimeforbarium
andmostradiopharmaceuticalstobecompletelydischargedfromthebody.DXA
measurementswillbedifculttointerpretforpatientstakingStrontiumorStrontium
ranelatebecauseDXAoverestimatestheactualbonemassduetothehigheratomic
numberofStrontiumcomparedtoCalcium.

Femurestimateswillbedifculttointerpretforpatientswithorthopedicmetaldevices
andprevioussurgicalinterventions.Themostcommoncomplicatingfactorsforfemur
estimatesareprostheticdevicesandsurgicalimplantsintheregionofthebonescan.
Resultsmaybeadverselyaffectedifthepatienthasdifcultywiththedesired25°
inwardrotationofthelegorwithmaintainingthispositionwithoutmovement.

TotalBodyestimatesrequireconsistentpatientpositioningforaccurateresultsand
willbedifculttointerpretforpatientswithorthopedicmetaldevicesandprevious
surgicalinterventions.Theoperatorshouldpayparticularattentiontothelocationof
thepatient'sarms,keepingthepositioningthesameforeachscan.Resultsmaybe
affectedifthepatientmovesduringthescan.

41

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

DeviceDescriptions

Structure

Thedeviceincludesthefollowingbasiccomponents:

1.Anx-raysourcewithappropriateltrationtoformawell-deneddual-energy

beam,

2.Anx-raydetectorcapableofmeasuringtheattenuatedbeamattwoenergylevels,

3.Asupportforholdingthesubjectbetweenthesourceanddetector,

4.Amechanicalmeanstomovethesourceanddetectorinarectilinearscanofa

selectedareaofthesubject’sbody,and

5.Softwareandelectroniccontrolsforthepreviouslymentionedcomponents.

6.Whereapplicable,phantomsandpositioningblocksareusedwiththesystem.

Dependingupontheenabledfeatures,thesecomponentsmayvaryormaynot
berequired.

7.Optionalsystemcomponentsincludethesmallroomkit,whichisusedwhen

thePCisclosetothetable;encapsulatedphantom,whichisanencapsulated
aluminumspineinanacrylicblock;andanuninterruptiblepowersource(UPS).

Thebonedensitometerisdividedintoascannerandacomputer.Thescanner
comprisesthex-raysourceanddetector,thepatienttable,themechanicaldrive
system,andthelowestlevelportionsofthecontrolsystem.Thescannerisin
communicationwiththecomputer,whichisastandardPC.Thecomputerrunsthe
enCOREsoftware,andthuscontrolsthescanner,acquiresscandatafromthescanner,
storesandanalyzesthedata,andinteractswiththehumanoperator.

DPX-BravoandDPX-Duo

TheDPX-BravoandDPX-Duomodelsusepencilbeamtechnologywithasingle-crystal
channelNaIdetectorandhaveacompacttabledesigntoprovidespaceefciency.

TheDPX-DuoandtheDPX-Bravocomeequippedwithascanarmthatswingstothe
sideofthetablewhennotinuseasadensitometerandtofacilitatepatientloading.
X-rayscanningisnotpossibleuntilthescanarmislockedintothescanposition.A
handlereleasesthescanarminterlockandallowsoperatortomovethescanarm
forpatientloading.Oncethepatientisloadedonthetable,theoperatormovesthe
scanarmbacktoscanningpositionandthearmlocksintoscanposition.Ifascan
isattemptedwithoutthescanarmlockedintoposition,thefollowingerrorwillbe
displayed:

ErrorDescription:
Swingarmnotlockedinscanningposition.Pleaselockbeforecontinuing.
CorrectiveAction:
Pleasetryagain.Iftheproblempersists,contactGELunarSupportforassistance.
Toretractthescanarmoncethescaniscompleted,homethescanarm.

42

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

Pulltheleveronthefrontofthescanarmtowardsyouandpushthescanarmtothe
leftuntilitrestsalongthebackofthescanningtable.Thepatientcanthensitupand
thetableisfreeofobstruction.

Thepowerswitchislocatedattheheadofthetable.Thereisalsoarollattheheadof
thetabletostoreupto21”x3”(53.34cmx7.62cm)exampaper.Thetableweight
limitis159kg(350pounds).

DPX-Bravo

Item

1
2
3
4

Description

Tablepad
Swingscanarm
Scanarmcontrolpanel
Exampaperrollandpowerswitch(headofscanner–notshown)

TheDPX-Duomodelalsohasmechanicalfeaturesincludingstirrups,procedure
drawer,storagedrawers,andpatientsteptoallowuseasanexamtablewhenbone
densitometryisdisabledandthescanarmisrotatedandlockedparalleltothetable.

43

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

DPX-Duo

DPX-NT/Pro/MD+

Item

1
2
3
4
5
6
7
8

Description

Patientstep
Storagedrawers
Stirrups
Tablepad
Swingscanarm(inscanningposition)
Scanarmcontrolpanel
Exampaperrollandpowerswitch(headoftable–notshown)
Proceduredrawer

TheDPX-NT,DPX-Pro,andDPX-MD+modelscomeinfullandcompactsizesanduse
pencilbeamtechnologywithasingle-crystalchannelNaIdetector.Thepowerswitch
islocatedonthelowerfrontpanel.Thetableweightlimitis136kg(300lbs).

44

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

DPX-NT

Item

1
2
3
4

Description

Powerswitch
Tablepad
Scanarm
Scanarmcontrolpanel

Prodigy/ProdigyPrimo/ProdigyAdvance/Prodigy
Pro/ProdigyForma

Prodigymodelscomeinfullandcompactsizesandusefanbeamtechnologywitha
16-channeldetector.Thepowerswitchislocatedatthefootofthescanner.Thetable
weightlimitis159kg(350lbs).

ProdigySeries

Item

1
2

45

X-rayBoneDensitometerwithenCOREv17software-UserManual

Description

Powerswitch
Tablepad

ProductInformation

iDXA/iDXAForma

Item

3
4

Description

Scanarm
Scanarmcontrolpanel

TheLunariDXAusesfanbeamtechnologywitha64-channeldetector,isascanner
designedforoptimalimagequality,andsupportspatient'sweightsto204kg(450lbs).

Thepowerswitchandexampaperrollislocatedattheheadofthescanner.

LunariDXASeries

Item

1
2
3
4
5

Description

Exampaperroll
Tablepad
Scanarm
Scanarmcontrolpanel
Powerswitch(headofscanner–notshown)

TheWarninglabelidentiesthelocationofpossiblepinchpoints.Whenthescanner
armisinmotion,makesurepossiblepinchpointareasareclearatalltimes.The
technologistmustkeepbothfeetawayfromthemovingcarriage.Patientlimbsmust
remaininsidetheboundariesofthetabletoptoavoidapinchbetweenthescanner
armandtable.

46

X-rayBoneDensitometerwithenCOREv17software-UserManual

ScannerTableAssembly

ScannerTable

ProductInformation

Theterm“scanner”isequalto“x-raybonedensitometer.”

NomodicationoftheScannerTableassemblyisallowed.Forservice,please
callGESupportoryourGEdistributor.

Thescannertableisusedtosupportthepatientduringameasurementorgeneral
examination(DPXDuoonly).Inaddition,thex-raysourceassemblyandother
electronicsarecontainedinsidethescannertable.

ScannerArm

Thelaserlight,emittedfromanapertureonthescannerarm,helpsyoulocatethe
measurementstartposition.Positioningswitchesletyoumovethescannerarmuntil
thelaserlightislocatedatthecorrectstartposition.Thestartpositionisdifferentfor
eachmeasurementtype.

OnDPXDuo/Bravoscanners,thescanarmhasareleaseandlockingmechanism
allowingtheupperarmtoswivelwhenthescannerisidle.Thescanarmmustbein
thelockedpositionoverthescannertabletoperformameasurement.

ScanArmControlPanel

Scanarmcontrolpanel:DPXBravo/Duo

47

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

1Alarmindicatorlights

2Levertolock/unlockswingarm

3Positioningswitches

4Emergencystopbutton

Scanarmcontrolpanel:DPXNT/MD+/Prodigy/ProdigyPrimo/ProdigyAdvance

1
2
3

Alarmindicatorlights
Emergencystopbutton
Positioningswitches

Scanarmcontrolpanel:iDXA

1
2

Alarmindicatorlights
Emergencystopbutton

48

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

3
4

Thefollowingtabledescribestheindicatorslocatedonthescanarmcontrolpanel.
Thex-ray,shutter,andlaserindicatorsareconsideredlowpriorityalarmconditionsas
denedinIEC60601-1-8.Thepowerindicatorisnotconsideredanalarmcondition.

SymbolIndicator

Positioningswitches
Startscanbutton

Status(on)

Green(power)

Yellow(x-ray)X-raytubeassemblyissupplyingx-rays

Yellow(shutter)Shutterisopen

Amber(laser)

Powerissuppliedtothescannertable

Laserison

EmergencyStopButton

Pushtheredemergencystopbuttontostopthescannerarmandimmediatelyshut
downx-raysinanemergency.Donotusetheemergencystopbuttontoroutinely
stopthescannerduringnormaloperation.

PositioningSwitches

Thepositioningswitchesmovethescannerarmanddetectortothemeasurement
startposition(thelaserlightindicatesthepositionofthedetector).TheBack/Front
switchmovesthedetectoracrossthewidthofthescannertable.TheLeft/Rightswitch
movesthescannerarmdownthelengthofthescannertable.

SwingArmPositionSensingSwitches

OnDPXDuo/Bravoscanners,theswingarmpositionsensingswitchesdetectthe
lockingstatusoftheswingarmandtheswingarmlatch.Theswingarmlatchmust
belockedandtheswingarmmustbeinthelockedpositionoverthescantable
beforeameasurementcanbeperformed.Releaseoftheswingarmlatchduringa
measurementwillabortthescanandthemeasurementdatawillbelost.

StartScanButton

OniDXAscanners,thestartscanbuttoninitiatesthepatientmeasurement.Thestart
scanbuttonislocatedonthedisplaypanelnearthepositioningswitches.

49

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

TrainingInformation

GEHealthcareoritsauthorizeddistributorsprovideindividual,hands-ontrainingas
partoftheinstallationprocedureforyoursystem.(GEdistributorsprovidetraining
forsystemsinstalledoutsidetheUnitedStates.)AnApplicationsSpecialistprovides
informationonsoftwareandhardwareoperations,andreviewsthewarningsand
cautionsinthemanuals.

Onlytrainedtechnologistsshouldoperatethesystem.New
technologistsshouldreceivetrainingpriortounsupervised
operationofthesystem.Additionaltrainingsessions
areavailableonrequestforanominalfee.Formore
information,contacttheGECustomerServiceDepartmentat
888-281-4947,oryourlocalGErepresentative.

Classications

Protectionagainstelectricshock:ClassI,TypeB
Protectionagainstwater:IPX0

InstallationandOperation

SoftwareInstallation

Operationmode:Continuousoperation
Thedevicecanneitherbeusedinammableanestheticmixturewithairnor

non-ammableanestheticmixturewithoxygenornitrousoxide.

OnlyindividualstrainedbyGEHealthcareshouldserviceorinstallthex-raybone
densitometer.DonotattempttoservicetheX-rayBoneDensitometer.CallGEService
oryourGEdistributorforsupport.

Beforeoperatingthex-raybonedensitometer,reviewSafety(26).

Ifloadingsoftware,youwillbeaskedforyoursystemnumberandfeaturecodeduring
theinstallationprocedure.Thesenumbersareprintedonasheetincludedwiththe
software.

1.PuttheDVDintheDVDdrive.

2.WhentheInstallationwindowappears,selecttheproductsoftwareoption.

Iftheinstallationdoesnotautomaticallystart,select
MyComputer ,selecttheDVDdrive,anddouble-clickthe
softwareinstallationicon.

3.Followthescreenpromptstoinstalltheprogram.

TheenCOREinstallationprogramautomaticallyappliesWindows732-bitService
Pack1andvalidatedMicrosoftSecurityupdatesonEnglishoperatingsystems,
ifnotalreadyinstalled.Onceallupdatesareapplied,thesystemautomatically
restartsandcontinueswiththeinstallationoftheenCOREproductsoftware.This
processmaytakeupto90minutes.

50

X-rayBoneDensitometerwithenCOREv17software-UserManual

Features

Dependingonthecountry,scannermodel,andnumberofoptionsyoupurchased,not
allofthefeatureslistedbelowmaybeincludedwithyourscanner:

HardwareFeatures

●DPXsystems:Pencilbeamtechnology.

●ProdigyandiDXAsystems:Narrow-anglefanbeamtechnologywithMulti-View

imagereconstruction.

●DPXsystems:Single-elementNaIdetector.

●ProdigyandiDXAsystems:Multi-elementdetector .Imagingperformancemeetsor

exceeds1.5mmholepairsandislimitedbytheProdigydetectorpitchof3.2mm.

●iDXAandDPX-Duo/Bravosystems:Paperrolldispenser.

●DPX-Duo/Bravosystems:Swingarm.

●DPX-Duosystems:Footrests,patientstep,twostoragedrawers,proceduretray.

SoftwareFeatures

ProductInformation

Notallfeaturesareavailableonallmodels.

●QuickViewmeasurementapplication

●Totalbodymeasurementandanalysis

●Pediatricspinemeasurementandanalysis

●Pediatrictotalbodymeasurementandanalysis

●Pediatricfemurmeasurementandanalysis

●Pediatricassessmentsofgrowthanddevelopmentincludingheightforage,BMC

forbonearea,boneareaforheight,leanbodymassforheight,andBMCforlean
bodymass

●Lateralspinemeasurementandanalysis

●Dual-energyvertebralassessment(lateralandAP)

●Spinegeometry

●Handmeasurementandanalysis

●Smallanimaltotalbodymeasurementandanalysis

●ClearViewlterforenhancingimagesbyreducingsofttissuenoiseandimproving

boneedges(useradjustable)

●Totalbody%fatandandroid/gynoid%fatestimation

●RestingMetabolicRate(RMR)estimation

●RelativeSkeletalMuscleIndex(RSMI)estimation

●Sarcopeniacalculator

●CoreScan–VisceralAdiposeTissue(VAT)estimation

●Bodycompositioncolorcodingandmapping

●APspinemeasurementandanalysis

●OneScanmeasurementapplication

●Femurmeasurementandanalysis

●Atypicalfemurfracturemeasurementandanalysis

51

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

●DualFemurmeasurementandanalysis

●Totalbodyandregionaltissuequantitation

●AndroidandgynoidROIanalysisonbodycomposition

●Forearmmeasurementandanalysis

●Orthopedichipmeasurementandanalysis(withextendedGruenanalysis)

●Orthopedickneemeasurementandanalysis

●ScanCheck(formerlyknownasComputerAidedDensitometry,orCAD)

●Composerreportingtools

●PracticeManagementtools

●DICOMandHL7interfacecapability

●SQLServerapplication

●TeleDensitometry

●Multi-userdatabasecapability

●OneVisioncapability

●AdvancedHipAssessment(AHA)hipstrengthanalysis

●Customregionofinterest(ROI)analysis

●Previousscanimagecomparison

●Automaticmetaldetection

●HIPAASecureView

●Patient/examdirectorywithmultipledatabases

●GlobalUIwithmultiplelanguages,regionalsettings

●SmartScanforscanwindowoptimizationanddosereduction

●Automaticscanmodeselection

●Autoanalysis

●ROIcomparison(copy)

●BMDorSBMD,BMCandareameasurements

●Referencedata:Lunar,NHANES,manyregionalpopulations,andcustomoptions

●ReferencedatacomparisonsT/ZscoresandpercentYA/AM

●FRAX10-YearFractureRisk

●Trending

QualityAssurance(QA)Features

●QAautomatedtestprogram

●QAtrending

●Six-pointcalibration

●APspinephantom

UserInformation

●UserManual

Options

●Uninterruptiblepowersupply(UPS)

52

X-rayBoneDensitometerwithenCOREv17software-UserManual

●SmallRoomkit

●Encapsulatedphantom

●PCcart

●Positioners

●Washabletablepad

ProductInformation

53

X-rayBoneDensitometerwithenCOREv17software-UserManual

ProductInformation

54

X-rayBoneDensitometerwithenCOREv17software-UserManual

DailyUse

DailyUse

3

1.Qualityassurance:Everymorning,beforeyoustartpatientmeasurements,

completethedailyQualityAssuranceprocedure.RefertoQualityAssurance(59).
Makesureyousaveyourprintedresultsforfuturereference.

2.Measurepatients:Iftimeallows,enterthePrimary,Secondary,andAdditional

dataforthepatientsyouexpecttomeasureduringtheday.RefertoMeasurement

(72).

3.Analyzeresults:Analyzeandprintresultsimmediatelyaftereachpatient

measurementiftimeallows.Otherwise,analyzeallofthepatientlesafterthe
lastpatienthasbeenmeasured.RefertoAnalysis(77).

4.Archiveexamles:Archiveyourexamlesbeforeyouleavefortheday.Inthe

unlikelyeventofacomputermalfunction,itisveryimportantthatyouhave
archivedlesofallofyourpatientmeasurementstorebuildyourdatabase.Refer
toArchiveExamFiles(55)forarchiveprocedures.

ArchiveExamFiles

5.Shutdowncomputer:Attheendoftheday,selectExitfromtheMainscreen,

selectShutDownfromtheClosewindow,andclickOKtoclosetheprogram.

Donotturnoffthescannerattheendofthedayfor
stationarysystems.

Eachday,archivenewexamlesfromyourcomputerharddrivetoanarchivedisk
orexternalharddrive.

Theprogramidentiesarchivedlesbylabelingthemwiththedrivelocationandthe
numberofthearchivedisk.Forexample:thethirdarchivedisklocatedindriveAis
labeledA:A3.LabelsforarchivedisksareshownintheLabelcolumnoftheImage
lelistontheDirectoryscreen.

Itisimportantthatyouwritethearchivenumberoneacharchivedisk.Ifitisnecessary
torestorearchivedlestotheharddriveorrebuildyourdatabase,theprogram
requiresthatyouusetheappropriatearchivediskaccordingtoitslabel.

1.SelectDirectoryfromtheMainscreenortheCommontoolbar.

55

X-rayBoneDensitometerwithenCOREv17software-UserManual

DailyUse

2.Completeoneoftheseprocedures:

Archiveallexamsforall
patients

Archiveallexamsforall
patientsinthecurrent
searchresults

Archiveallexamsfor
selectedpatient

Archiveselectedexam1.SelectapatientfromthePatientlist.

1.SelectArchivefromtheDirectorytoolbar .

2.Inthedialogbox,selectArchiveallexamsforall
patients.

1.Selectasearcheldfromthedropdownmenu.

2.Entersearchcriteriaintheeldprovided.

3.ClicktheSearchbutton.

4.SelectArchivefromtheDirectorytoolbar .

5.Inthedialogbox,selectArchiveallexamsforall
patientsinthecurrentsearchresults.

1.SelectapatientfromthePatientlist.

2.SelectArchivefromtheDirectorytoolbar .

3.Inthedialogbox,selectArchiveallexamsforselected
patient.

2.Selectthepatientexamleyouwanttoarchive.

3.SelectArchivefromtheDirectorytoolbar .

4.Inthedialogbox,selectArchiveselectedexam.

3.SelectOK.
Theprogramarchivestheexamlesfromthecomputerharddrivetothearchive

diskorexternalharddrive.ThearchivenumberfortheleisshownintheLabel
columnoftheImagelist.

4.Ifanarchivestoragesourceneedstobeinitiated,theprogrampromptsyouto
insertalabeledarchivediskintheappropriatediskdrive.Insertadiskasdirected.

SafeUseGuidelines

Obeythesesafetyguidelinesatalltimes.

●Readthemanualbeforeyouoperatethescanner.

●Thetechnologistoperatingthescannermustremaininvisualcontactwiththe

patientduringthemeasurement.

●Donotattempttoservicethescanner.CallGESupportoryourGEDistributor.

●Whenthescannerisnotinuse,makesuretheShutterOpen,X-ray,andLaser

lightsareoff.

●Donotputexcessivepressureonthescannerarm.

●Usethescannertableforpatientmeasurementsandexaminations(DPXDuo)only:

donotsit,standorlieonthetableforotherpurposes.

●Donotletliquidstouchthecomputerorscannertablemechanicsandelectronics.

56

X-rayBoneDensitometerwithenCOREv17software-UserManual

EmergencyStopButton

Bepreparedtoabortthescanintheunlikelyeventarmmotionstopswith
thex-rayson.

Theemergencystopbuttonistheround,redbuttonlocatedonthescannercontrol
panel.

Donotusetheemergencystopbuttontoroutinelystopthescannerduringnormal
operation.

1.PushtheEmergencyStopbuttontostopameasurementinanemergency.
Powertothescannertablemotors,x-raytubehead,shutter ,andlaseristurnedoff.

2.SelectOKinthemessagewindowonthecomputerscreen.

TestEmergencyStopButton

DailyUse

Ifthereisahardwareproblem,DONOTtrytomeasurea
patient.CallGESupportoryourGEdistributor.

Testtheemergencystopbuttononceamonth,asfollows:

1.StartastandardAPSpinemeasurement.Donothaveapatientonthetable.

2.Pushtheemergencystopbutton.
MakesuretheX-rayandShutterlightsareoffandthatamessageonthe

computermonitorindicatestheemergencystopbuttonisactivated.

3.OnDPXNT/MD,DPXDuo/Bravo,andProdigysystem:Pushtheemergencystop
buttonagaintoresetthesystem.

4.Donotsavethepatientmeasurement.

Iftheemergencystopproceduredoesnotwork,callGESupportoryourGEdistributor.

CleanScannerTableEnvironment

Vacuumanddustthesystemsiteweekly.Dustthesurfaceofthesystemregularly
andusenonabrasivecleanerstoremovedirt.Donotletliquidspenetrateinsidethe
scannertable.

Donotconnectavacuumcleanertothesameelectricaloutletasthescanner.

Propercleaningandhandlingproceduresmustbefollowedtopreventthe
possibilityofcross-infectionsbetweensubjectsscannedonthesamesystem.
Cleananddisinfectthesystemaccordingtoyourlocalandcountryspecic
hygienicregulations.

AnnualMaintenance

57

GEHealthcarerecommendsthatyouscheduleannualpreventivemaintenanceby
aGE-authorizedserviceengineerafteryourwarrantyperiodexpires.ContactGE
SupportoryourGEdistributor.

X-rayBoneDensitometerwithenCOREv17software-UserManual

DailyUse

X-RayTubeandLaserAssemblyMaintenance

ThereareNOUSER-SERVICEABLECOMPONENTSinsidethex-raytubeheadand
laserassemblies.

DONOTattempton-siteservicing.CallGESupportoryourGEdistributorimmediately
ifthesystemmalfunctions.

DONOTattempttomaintainorrepairthecomponentsandscannertable.Doingso
voidsallcurrentwarrantyandservicecontracts.

58

X-rayBoneDensitometerwithenCOREv17software-UserManual

QualityAssurance(QA)

DailyQualityAssuranceProcedure

CompleteQualityAssuranceproceduresdaily.MakesureeachQAprocedurepasses.
Ifyoursystemdoesnotpassatest,checkthepositionofthecalibrationblockand

completetheQualityAssuranceprocedureagain.Iftheprocedurefailsasecondtime,
callGESupportoryourGEdistributor.

CompleteaQualityAssurance(QA)testeachmorningbeforeyoumeasureapatient.If
theroomtemperaturechangesmorethan5°Cduringtheday,thenperformanother
DailyQA.Thisprocedurecalibratesandveriesfunctionalityaswellastheaccuracy
andprecisionofthedensitometer.TheQAprocedureshouldbeperformedaminimum
ofonceaweekifthescannerisnotbeingused.SaveallQAprintoutsforoneyear.

UsetheblackcalibrationblocktocompleteaQAtest(thecalibrationblockconsists
oftissue-equivalentmaterialwiththreebone-simulatingchambersofknownbone
mineralcontent).LeavethepadonthescannertableduringtheQAprocedure.

1.SelectQualityAssurance(F5)fromtheMainscreenorselectQAfromthe
Commontoolbar.

4

2.SelectStart.
Amessageinstructsyoutopositionthecalibrationblock.

3.Putthecalibrationblockonthepadsothatthelaserlightrestsinthecenterofthe
cross-hairlabelonthecalibrationblock,andthebrassisonthebottom.

QAcalibrationblock

1
2

Laser
Brassonbottom

59

X-rayBoneDensitometerwithenCOREv17software-UserManual

QualityAssurance(QA)

PrecisionandAccuracy

Precision

4.SelectOK,andfollowthescreenpromptstocompletetheQAprocedure.
IftheQAtestdidnotpass,repositionthecalibrationblockandrepeatthe

procedure.
Iftheprocedurefailsasecondtime,callGESupportforassistance.

5.ToprinttheQAresults(iftheautoprintoptionisnotset)selectReport.Keep
theQAprintoutforoneyear.

6.TotrendtheQAresults,selectSettings,chooseTableorGraph,andselectthe
resultthatyouwouldliketotrend.SelectOK.

Failuresarerepresentedbyreddotsonthegraph.

PrecisionistheabilitytorepeatedlyobtainthesameBMDvalue.Precisionerrormay
bereportedasastandarddeviation(SD)ing/cm

2

orasacoefcientofvariation(%CV)

whichisdenedastheSD/MeanBMDinpercent.
ThefollowingtabledenestheexpectedprecisionerrorformostcommonDXA

measurements.

Site

APspineBMD
FemurBMD

TotalbodyBMD

Precision(g/cm

0.010g/cm

0.010g/cm

0.010g/cm

2

)

2

2

2

Precision(%CV)

1.0%L1-L4orL2-L4

1.0%

1.0%

RegionofInterest

DualFemurTotal
Total

Precisionforothersiteswillrange1-3%.Precisionmaybeaffectedbyoperator
techniqueandothervariablesassociatedwithpatientanatomy.SeeCautionsforDXA

Determinations(41

)andPrecisionCalculator(181)foradditionaldetails.

APSpineThicknessDependence

TheprecisionofBMDmeasurementsoverasofttissuethicknessrangefrom15cmto
25cmislessthanorequalto2%(%CV).

APSpineDependenceonHeightaboveTabletop

TheprecisionofBMDmeasurementsovera5cmchangeinobjectplaneislessthan
orequalto2%(%CV).

TheprintedDXAreportsdisplayafootnoteindicatingtheprecisionerrorassociated
withameasurement:

1–Statistically68%ofrepeatscansfallwithin1SD(±0.010g/cm

2

forAPSpineL1-L4)

Accuracy

Accuracyindicateshowcloseameasuredvalueistotheactualvalue.
TheDailyQAfeaturemeasuresastandardblackblockwhichissuppliedwith

eachscanner.TheblockconsistsofthreechamberssimulatingBMDvaluesof

60

X-rayBoneDensitometerwithenCOREv17software-UserManual

QualityAssurance(QA)

QAControls

approximately0.500g/cm

2

,1.000g/cm

2

,and1.500g/cm

2

.DuringDailyQA,the
BMDforeachchamberismeasuredandcheckedthatitiswithin0.030g/cm
itsexpectedvaluewhichensuresthelinearcorrelationforBMD(R≥0.99).Atthe
endofQA,theentireblockisscannedtosimulateanAPspinemeasurementand
theaccuracyischeckedagain.

NavigatetoQA>QATrendGraphstomonitorQAtrendsforkeyvalues.

FormoreinformationabouttheQAGUI,refertoQualityAssuranceScreen(235)and

QualityAssuranceToolbar(236).

ForinformationaboutcustomizingtheQAoptions,refertoQATab(249)intheOptions
section.

IconItem

StartupTest

MechanicalTest

Description

●DatabaseValidation

●ScannerSelf-test

●QABlockSearch

●Peaking

●BeamStop

●TransverseDistance

●LongitudinalDistance

2

of

ClicktheTrendtooltoexittheQAprocessscreen.

QATrendReportingOptions

OntheQAscreen,clickSettings.ThesettingsscreenprovidesmanyoptionsforQA
trendreportingcomponents.

IntheupperrightpanelareoptionsfortheQAReportType:

X-ray/Detector

Calibration●BMDvaluesofHigh,Mediumand

PhantomBMD,BMC,Area,Edgedetection

●SpectrumSpillover

●ReferenceCounts

●DetectorStatus

Lowblockchambers

●TissuevaluesofLean,Normaland

Fatblockvalues

●Trendanalysis

●QAPhantomReport

●Ancillarypage

61

X-rayBoneDensitometerwithenCOREv17software-UserManual

QualityAssurance(QA)

●LegacyQAReport

QAPhantomReport

QAAncillarypage

62

X-rayBoneDensitometerwithenCOREv17software-UserManual

LegacyQAReport

QualityAssurance(QA)

MeasuretheSpinePhantom

TheenCORE-basedscannerdoesnotrequireaseparateQualityControltoberun
inadditiontoQualityAssurance.ThedailyQAprocedurerunonthescannerboth
calibratesthemachineandhas“bone”chambersthatareusedforQualityControl
measurements.Thisremovesthenecessityofrequiringaphantomtobemeasured
bytheuserforseparatecontrolmeasures.Thephantomisconsideredaservice
tool.Everysystemincludesanaluminumspinephantomandwatercontainer.An
encapsulatedphantomisavailableforpurchase.

Watercontainer(left)andencapsulatedphantom(right)

Aspinephantombaselinewasperformedwiththeinstallationofyourscanner.Thisis
foundinthepatientdatabase.Forgeneraluse,usethesamepatientinformationthat
wasestablishedwiththespinephantombaselinescan.

63

X-rayBoneDensitometerwithenCOREv17software-UserManual

QualityAssurance(QA)

Fordetailsonperformingthescan,refertoAPSpineMeasurementandAnalysis(86).

1.Put15cmofwaterintheplasticcontainerandpositionthealuminumphantom

inthemiddleoftheplasticcontainer.

2.PositionthephantomsothatL5istowardthefootofthescanner.

3.FromtheMainscreen,selectMeasure(F2).

4.Haveyoumeasuredthephantombefore?

a.Ifyes,selectthephantomfromthepatientlistandcontinuetostep7.
b.Ifno,continuetostep5and6torecordtheinformationforthespinephantom.

5.Recordtheprimaryinformationinthedialogbox:

Field

FirstnameSpine
Middleinitial
LastName
BirthDateRecordthecurrentdateminus40years.

Height67inchesor170centimeters
Weight154poundsor70kilograms
Sex
EthnicGroupWhite

Entry

None
Phantom

Forexample,iftoday'sdateisSeptember
28,2011,type09/28/1971.Donot
changethisdateforfuturespinephantom
measurements.

Male

6.Selectthesecondarytabandrecordthefollowinginformation:

Field

Comments

Entry

Recordthephantomnumbergivenon
theL5regionofthespinephantom.Also
recordyourSystemIDnumber.This
numberislocatedinTools>UserOptions
>Systemtab.

7.SelectPositionfromthetoolbar.

Agraphicisshownillustratingthecorrectpatientandlaserpositionforthescan
type.

8.Positionthelasercross-hairontheletter“R”intheword“LUNAR”ontheL5

vertebralbodyofthephantom.

64

X-rayBoneDensitometerwithenCOREv17software-UserManual

9.Startthescan.

QualityAssurance(QA)

10.WhenapproximatelyhalfofT12isimaged,selectAbortfromthetoolbar.

11.ChooseSavemeasurementfromtheSavedialogboxandselectOKifthe

measurementwasperformedcorrectly.

12.Forspinephantomanalysis,itisnecessarytoverifyandadjustaccordinglyfor

thefollowingvertebralheights:
L2:3.00cm+/-.02cm
L3:3.50cm+/-.02cm
L4:4.00cm+/-.02cm
L2-L4regionheightshouldbe10.5cm

13.OntheAnalysisscreen,selecttheROItooltoviewthisinformation.

65

X-rayBoneDensitometerwithenCOREv17software-UserManual

QualityAssurance(QA)

66

X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

Measurement:OverviewandWarnings

PatientConsiderations

Obeythesepatientconsiderationsbeforeyoustartapatientmeasurement:

●Clothingrestrictions:Makesurethepatientremovesitemsthatcanattenuate

thex-raybeam,suchasclothingwithzippers,snaps,buckles,andbuttons.Ask
patientstowearajoggingsuittotheexamorgivethemanexaminationgown
whentheyarrive.

●Radionuclideandradiopaqueagents:Makesurethepatienthasnotingestedor

beeninjectedwithradionuclidesorradiopaqueagentsinthepast3to5days.If
thepatienthastakenteststhatusesuchagents,postponethemeasurementuntil
alltracesoftheelementhaveleftthepatient’sbody.A72-hourwaitingperiodis
usuallylongenoughformostagentstoleavethepatient’sbody.However ,consult
yourradiationsafetyofcer(RSO).

●Pregnancyrestrictions:Ifitisnecessarytomeasureapregnantpatient,thefetus

couldbeexposedtosmallamountsofradiation.Postponethemeasurementuntil
theendofpregnancyifclinicalmanagementisnotaffected.Thedecisionto
subjectafetustoradiationexposuremustbemadebythereferringphysician,
notingthat1)bonequalityformostpatientsdoesnotsignicantlychangeduring
pregnancyand2)intheadvancedstagesofpregnancy,thefetus’mineralizedbone
caninterferewithmeasurementsofthemother’sspineandfemur .

●Metaldevices:BMDestimatesaredifculttointerpretforpatientswithorthopedic

metaldeviceswithinthescaneld.

5

MeasurementWarnings

67

EachscannerisequippedwithaClassIILaserthatislessthan1milliwattin
strength.DONOTST AREINTOTHEBEAM.

Removefoamlegblockpriortopositioningscanarmoverthepatientand
immediatelyaftercompletinganAPSpinescan.

Verifythatthepatient'shead,arms,knees,andanyotherbodypartsarenot
indirectpathofamovingscanarm.

X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

MeasurementModes

Patientthicknessdeterminestheappropriatemeasurementmode.Theprogram
defaultstotheappropriatemodebasedonthepatient'sheightandweight.Default
scanparametersarerecommendationstobeapplieddirectlytoallowoptimized
operation.Theoperatormakesthenaldecisionbasedonpatientthicknessbefore
startingtheexam.Theselectionofmeasurementmodesinuencesthepatient
radiationexposure.Formoreinformationaboutradiationexposureandmeasurement
modes,refertothesectionCurrentandTypicalDoseTables(307).

iDXA:PatientThicknessLimitsforenCOREMeasurementModes

iDXAiDXAForma

Site

APSpine

Femur

TotalBody

Mode

Thick
Standard
Thin
QuickView
Thick
Standard
Thin
QuickView
Thick-AFF
Standard-AFF
Thin-AFF
Thick
Standard
Thin

Patient
thicknessor
weight

>25cm>25cm
13-25cm13-25cm
<13cm<13cm
>13cm
>25cm>25cm
13-25cm13-25cm
<13cm<13cm
>13cm
>25cm>25cm
13-25cm13-25cm
<13cm<13cm
>25cm>25cm
16-25cm16-25cm
<16cm<16cm

Patientthickness

orweight

NA

NA

Small<9kg(20lb)<9kg(20lb)

APVA

OrthopedicHip

LVA

LateralStandardAllthicknessesAllthicknesses

68

X-rayBoneDensitometerwithenCOREv17software-UserManual

Thick
Standard
Thin
Thick
Standard
Thin
Standard
Thin

>25cm>25cm
13-25cm13-25cm
<13cm<13cm
>25cm>25cm
13-25cm13-25cm
<13cm<13cm
>13cm>13cm
<13cm<13cm

iDXAiDXAForma

MeasurementandAnalysis

Site

Mode

Patient
thicknessor
weight

Forearm

StandardAllthicknessesAllthicknesses
HandStandardAllthicknessesAllthicknesses
OrthopedicKneeStandardAllthicknessesAllthicknesses

iDXA:SmallAnimalWeightLimitsforenCOREMeasurementModes

iDXAiDXAForma

ModePatientWeightPatientWeight

SmallAnimal

Large

>20kg>20kg
Medium2.0-20.0kg2.0-20.0kg
Small<2.0kg<2.0kg

Prodigy:PatientThicknessLimitsforenCOREMeasurementModes

Prodigy,
Prodigy
Pro,Prodigy
Advance

Patientthickness
orweight

ProdigyPrimo,
ProdigyForma

Site

Mode

Patient
thicknessor

Patientthickness
orweight

weight

APSpine

Thick
Standard
Thin
QuickView

Femur

Thick
Detail
Standard
Thin
QuickView
Thick-AFF
Standard-AFF
Thin-AFF

>25cm>25cm
13-25cm13-25cm
<13cm<13cm
>13cm

NA
>25cm>25cm
>13cm

NA
13-25cm13-25cm
<13cm<13cm
>13cm
>25cm
13-25cm
<13cm

NA

NA

NA

NA

69

X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

Site

TotalBody

APVA

OrthopedicHip

LVA

Prodigy,
Prodigy
Pro,Prodigy
Advance

Mode

Patient
thicknessor
weight

Thick
Standard
Thin

>25cm>25cm
16-25cm16-25cm
<16cm<16cm

Small<27kg(60lb)

Thick
Standard
Thin
Thick
Standard
Thin
Standard

>25cm>25cm
13-25cm13-25cm
<13cm<13cm
>25cm>25cm
13-25cm13-25cm
<13cm<13cm
>13cm>13cm

ProdigyPrimo,

ProdigyForma

Patientthickness

orweight

<27kg(60lb)(N/A

onPrimo)

LateralStandardAllthicknessesAllthicknesses
Forearm

StandardAllthicknessesAllthicknesses
HandStandardAllthicknessesAllthicknesses
OrthopedicKneeStandardAllthicknessesAllthicknesses

Prodigy:SmallAnimalWeightLimitsforenCOREMeasurementModes

Prodigy,
Prodigy
Pro,Prodigy
Advance

ModePatientWeightPatientWeight

SmallAnimal

Large

Medium2.0-20.0kg2.0-20.0kg

Small<2.0kg<2.0kg

>20kg>20kg

(N/AonPrimo)

ProdigyPrimo,
ProdigyForma

70

X-rayBoneDensitometerwithenCOREv17software-UserManual

DPX-Bravo/Duo:PatientThicknessLimitsforenCOREMeasurementModes

MeasurementandAnalysis

Site

APSpine

Femur

OrthopedicHip

ModePatientthickness

Thick>25cm

Standard15-25cm

Thin<15cm

Thick>25cm

Detail>15cm

Standard15-25cm

Thin<15cm

Thick>25cm

Standard15-25cm

Thin<15cm

LateralStandardNA

ForearmStandardAllthicknesses

DPX-NT/MD+:PatientThicknessLimitsforenCOREMeasurementModes

Site

APSpine

Femur

ModePatientthickness

Thick
Standard
Thin
Thick
Detail
Standard
Thin

>25cm
15-25cm
<15cm
>25cm
>15cm
15-25cm
<15cm

71

X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

Site

TotalBody

OrthopedicHip

LateralStandardAllthicknesses
Forearm

ModePatientthickness

Thick
Standard
Thin
Thick
Standard
Thin

StandardAllthicknesses

MeasurementProcedures:Overview

Thissectiondescribesthebasicstepsnecessarytocompleteapatientmeasurement.
Thesestepsmustbecompletedintheordergiven.Reviewthestepsbeforeyoustarta
patientmeasurement.

1.Recordorselectpatientinformation:

●Recordinformationforanewpatient(73),or

●Selectapatientrecordfromthedatabase(72)

2.Selectthemeasurementsite:

>25cm
15-25cm
<15cm
>25cm
15-25cm
<15cm

●APSpine(86

●Femur/DualFemur(91)

●Forearm(110)

●TotalBody(114

●LateralSpine(143)

●LVAMorphometry(147)

●LVASpineGeometry(155

●APVAMorphometry(158)

●APVASpineGeometry(160)

●DualVA(APVAandLVAinonescan)(163)

●Pediatric(163

●Hand(167)

●OrthopedicHip(170

●OrthopedicKnee(174)

●SmallAnimal(177

)

)

)

)

)

Aftermeasurement,continuewithanalysis(77).

SelectExistingPatientRecord

)

SelectapatientforanewmeasurementfromeithertheMainscreenortheDirectory
screen.UsetheSearchoption(233)tondthepatient,ifnecessary.

FromtheDirectoryscreen

72

X-rayBoneDensitometerwithenCOREv17software-UserManual

RecordNewPatientInformation

MeasurementandAnalysis

1.InthePatientlist,highlightthepatientandselectMeasurefromtheCommon
toolbar.
TheNewMeasurementscreenisshown.

FromtheMainscreen

1.SelectMeasure.

2.InthePatientInformationdialogbox,selectFind.

3.Double-clickthepatientinthePatientlist.

4.InthePatientInformationdialogbox,verifythatthepatientinformationiscorrect,
andthenselectOK.

TheNewMeasurementscreenisshown.

1.SelectMeasurefromtheMainscreenorNewfromtheDirectorytoolbar.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

2.RecordthenecessaryinformationinthethreetabsinthePatientInformation
dialogbox.

PatientInformationdialogbox

●Primarytab:Youmustrecordthepatient’sname,birthdate,height,and

weighttocompleteapatientmeasurement.Changethedefaultgenderor
ethnicityintheTools>UserOptions>Directorytab>DirectoryRulesand
Defaultsbutton.

●Secondarytab:TheSecondarytabletsyourecordcommentsand

administrativeinformationthatisnotrequiredtocompleteapatient
measurement.IftheISCDguidelinesareturnedonunderTools>UserOptions
>Systems,itisimportanttoenteramenopauseageforpostmenopausal
womenbecausetheWHOcriteriaareonlyappliedtopostmenopausalwomen
andmenage50andolder.

●Additionaltab:TheAdditionaltabletsyourecordfracture,indication,and

treatmentinformationforthepatient.ThetabalsoallowsyoutoassignICD-9
orICD-10codestoeachfracture,indication,andtreatmentappliedtoall
patients.Inaddition,youcanenterthepatient’sinsuranceinformation.This
informationisnotrequiredtocompleteameasurement.

74

X-rayBoneDensitometerwithenCOREv17software-UserManual

3.SelectOKwhenyouhavenishedrecordingthepatientinformation.
WhenyouattempttoaddanewpatienttotheDirectory,thesystemchecks

whetherthepatientalreadyexists.Ifthesystemndspotentialduplicates,you
arepromptedtoeitherselectanexistingpatientortocreateanewpatient.
Preventingduplicatepatientrecordsisimportantbecauseasinglepatientrecord
isneededtotrendapatient’sexamdataovertime.

Youcancongureyoursystemtoevaluateeitherthepatientname,birthdateand
patientIDoronlythepatientIDwhencheckingforduplicatesusingTools>User
Options>Directorytab>DirectoryRulesandDefaultsbutton.Pleaseseethe

DirectoryTab(241

IfyoustartedfromtheMainscreen,theNewMeasurementscreenisshown.
Proceedwiththemeasurement.

IfyoustartedfromtheDirectoryscreen,highlightthepatient'snameandselect
MeasurefromthetoolbartoopentheNewMeasurementscreen,andthen
proceedwiththemeasurement.

SelectMeasurementSite

MeasurementandAnalysis

)sectionformoreinformation.

AbortMeasurement

TheNewMeasurementscreenshowsaskeletalimageofthesitesyoucanselectto
measure.

NewMeasurementscreen

1.OntheNewMeasurementscreen,clickthesiteyouwanttomeasure.
ThesiteyouselectishighlightedintheExamlist.

2.Followthemeasurementprocedureforthesiteyouselected.

RefertoMeasurementModes(68)formoreinformation.

Iftheimageisnotcorrect,orifyoudeterminethatasufcientareaofthe
measurementhasbeenobtained,selectAbort(F5)fromtheNewMeasurement
toolbar.

WhenyouselectAbort,themeasurementstopsautomaticallywhenthedetector
reachestheedgeofthescanwindow.Amessageshowstheseoptions:

●ResumeMeasurementSelectthisoptiontocontinuethemeasurement.

●SaveMeasurementSelectthisoptiontosavethecurrentmeasurement.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

OneVision

●RepositionthismeasurementanddonotsavetheabortedmeasurementSelect

thisoptiontostartthemeasurementagainusingthesamesettings.Theboxthat
isshownaroundtheimageshowsthemeasurementarea.Usethearrowkeys
tomovetheboxandrepositionthemeasurement.SelectStartfromtheNew
Measurementtoolbartorestartthemeasurement.

●"SetupanewmeasurementanddonotsavetheabortedmeasurementSelect

thisoptiontochangethesettingsforthemeasurement.

TheOneVisionfeatureallowsyoutosetupmultiplemeasurementsinoneexam.This
eliminateskeystrokesandimprovesthroughputforcustomersthatroutinelyperform
multiplemeasurementsoneachpatient.OneVisionisrequiredforDICOMorHL7
reportinginterfaces.Bydefault,theenCOREsoftwareincludestheexamcombinations
ofAPSpine+DualFemur,APSpine+DualFemur+LVA,andDualVA(LVA+APVA).Exam
combinationsarefoundatthetopoftheExamlistontheNewMeasurementscreen.
Theimagesincludedintheexamaredisplayedinatabview.

WhenscanningwithaseriesofOneVisionscantypes,selectNexttoproceedtothe
nextimagesiteintheexam,orRepeatthecurrentmeasurement.RefertoBasic

MeasurementProcedures(72)forinformationaboutobtainingappropriateimage

measurements.

CreateExamProtocols

YoucancreateyourownexamprotocolswiththeOneVisionfeature.

1.SelectMeasure>CreateExams.

2.Tocreateanexamprotocol,selectNew.
Youcanalsodelete,rename,oreditexistingexamprotocolsfromtheCreate

Examdialog.

76

X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

3.Enteraprotocolnameintheboxprovided,thenselectOK.
Itisrecommendedthatyouenteranamethatdescribeseithertheimages

includedintheexamoraspecicdescriptionoftheexam.
Aftertheprotocolnameisentered,denethemeasurementsitesincludedinthe

examandthesequenceofthemeasurementsintheexam.

4.Selecttheimagesitefromtheavailablesitesontheleft,andselectAddtoaddthe
imagesitetotheexam.

5.UsetheUpandDownbuttonstomodifythesequenceofimagemeasurements
intheexam.

6.Whennished,clickOK.

QuickView

QuickViewoffersafast,10secondspineorfemurscan.Measurementandanalysis

proceduresarethesameasotherscanmodes.
ThelargerpixelwidthofQuickViewresultsinreducedimageresolution.
Standardscanmodesprovideoptimalprecisionandarerecommendedforfollow-up

scanstomonitorchangesinBMD.
Formoredetailsonthescanmodespecications,refertoMeasurementModes(68

AnalysisProcedures:Overview

Thissectiondescribesthebasicstepsnecessarytoperformanalysisofacompleted

patientmeasurement(72).Thesestepsmustbecompletedintheordergiven.Review

thestepsbeforeyoustartanalysis.

TheresultstabsforAPSpine,Femur,Forearm,andTotalBody
imagesincludeaScanCheck(183).UsethelistofYes/No
questionstoassistinanalysis.Thereisaspaceforcomments.
YoucanprintthechecklistbyselectingtoprintScanCheckin
theReportCenter.

1.Selectanimage(77)

2.Adjusttheimage(78)

●Advanced:AdjustROIs(79)

●Advanced:Adjustpointtyping(79)

3.Completeanalysisfortheselectedsite.

SelectImage

Thesebasicstepsapplytoallimages.Forspecicinstructionsaboutsiteanalysis,
refertothetopicforthespecicsite(forexample,APSpineAnalysis(89)orFemur/Dual

FemurAnalysis(96)).

).

1.FromtheMainscreen,clickAnalyze,selecttheimagetoanalyze,andclickOK.
Or,fromtheDirectoryscreen,selectthepatientfromthePatientlist,selectthe

imagetoanalyze,andclickAnalyze.
YoucanusetheSearchoptiontolocateapatientinalargedatabase.

77

X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

AdjustImage

2.Adjusttheimageasneeded.
enCOREtypicallyperformstheanalysisautomatically.DonotchangeROIsor

pointtypingunlesstheanalysisshowsanobviousneedforcorrections.

Afterselectinganimage(77),youcanadjustitasneeded.

1.SelectImagingfromtheAnalyzetoolbartoadjusttheimage:
TheImageToolswindowisshown.

2.Usethiswindowtochangethegraylevelsoftheimageandzoomtheimage.
TheImageToolswindowshowsaboneproleandgivestheseoptions:

●Brightness:Toadjustthebrightnessfortheimage,clickanddragthe

brightnessscrollbarrightorleft.

●Contrast:Toadjustthecontrastfortheimage,clickanddragthecontrast

scrollbarrightorleft.

●ClearView:ForLVAandiDXAAPSpine,Femur,andForearmimages,youcan

adjustthesharpness.Toincreaseordecreasethesharpnessoftheimage,
movethearrowupordowntheClearViewscale.

●Zoom:Tozoomtheimage,usethebartoscrollthroughthepercentagevalues.

UsethePantooliftheimageislargerthanthewindowareaontheAnalyze
screen.

3.ClicktheDialogSizeiconinthelowerleftandselectAdvancedtoadjust
Threshold,Range,Low/HighControls,orImageTypeandtoresetcontrast.

4.Usethesetools(shownontheAnalyzescreen(231))tomagnifyanimageduring
analysis:

Icon

Tool

ResetModeSelecttodeactivatetheZoomandPan

ZoomImage

PanImage

ZoomSliderUsetheZoomSlidertozoomtheimage

Description

Imagetools.
SelecttheZoomImagetooltozoomin

oroutontheimage.Clicktheimageto
zoomin,orclicktozoomout.

Ifyouzoomtheimagelargerthanthe
viewableareaonthescreen,usethe
PanImagetooltoviewhiddenareas
oftheimage.Clicktheimageanddrag
thecursortopantheimage.

inorout

78

X-rayBoneDensitometerwithenCOREv17software-UserManual

Advanced:AdjustROIs

ROIsdonotneedtobeadjustedinmostcircumstances.Theproceduresforadjusting
ROIpositionarespecictoeachmeasurementsite.

SomeROIadjustmentswillrendertheresultsunreliable.

Seethespecicimagetyperecommendationsforanalysis.

Advanced:AdjustPointTyping

Pointtypingisatoolthatletsyouviewhowtheprogramclassiedthesamplepoints,
andchangetheclassicationifnecessary.Thepointtypingdeterminestheplacement
ofboneedges.

enCOREanalysisautomaticallyassignspointtypingtoanimageandusuallyrequires
noadjustment.Signicantchangestopointtypingwillaffectboththeresultsand
reproducibilityofanimage.

MeasurementandAnalysis

Theproceduresthatfollowgiveinstructionstoexamineandadjustpointtypingfor
animage.

Donotadjustthepointtypingunlesstheprogramhasmadeobviouserrors.Change
thepointtypingonlyiftheareathatneedstobechangedislargerthanthedefault
cursorsize.ItisrecommendedthatchangesbelimitedtoBoneandNeutralpoint
typing.

1.SelectPointsfromtheAnalyzetoolbar.
ThePointTypewindowisshown.Theprogramautomaticallydeterminesifa

sampleisbone,tissue,neutral,air,orartifact:

●Bone:VerifythattheboneistypedasBone.

●Artifact:Foreignmaterialtobeexcludedinanalysis.

●Tissue:Tissuepointtypingisspecictoeachmeasurementsite.

●Neutral:SelecttheNeutralbrushtypeandverifythatathinborderofneutral

samplesisshownaroundthebone.
NeutralpointtypingisnotavailableonTotalBodyscans.

2.Toadjustpointtyping,selectabrushtype(BoneorNeutral)andabrushsize.

3.Clickontheimagetomakeyourchanges.

4.Ifnecessary,selecttheArtifactbrushtopointtypeanartifactintheimage.

●Toreturntheimagetoitsoriginalstate,selectReset.

●Tocorrecterrorsyoumakewhileadjustingthepointtyping,selectUndo.

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X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

ExamplesofCorrectBonePointTyping

APSpinecorrectbonepointtypingFemurcorrectbonepointtyping

ForearmcorrectbonepointtypingLateralspinecorrectbonepointtyping

ExamineResults

ReferenceGraph

80

TheResultstabsontheAnalyzescreenletyoureviewBMD,reference,trend,and
compositionresults.

Tochangedefaultsettingsforgraphs,referencedata,andresultstables,referto

Options(243).

Thereferencegraphprovidesavisualrepresentationoftheexamresultscompared
toareferencepopulation.Apatient'sBMD,expressedingramspercentimeter
squared,isplottedagainsthisorherage.Thesquarewithablackdotrepresentsthe
patient.Eachcoloredbarbelowthedarkgreensectionrepresentsonestandard
deviationbelowtheYoungAdultvalue.Thethinlineseparatingthedarkgreenfrom
thelightgreenindicatesaT-Scoreof–1.Followingacross,thepatient’sT-Scorecan
bedetermined.

TheT-Scoreindicateshowmanystandarddeviationsapatient'sBMDisfromthe
meanBMDvalueofthehealthyYoungAdultreferencepopulation.AnegativeT-Score

X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

indicatesthepatient'sBMDisbelowtheYoungAdultvalue.ApositiveT-Score
indicatesthepatient'sBMDisabovetheYoungAdultvalue.

T-Score

ThebluebardisplaystheAgeMatchedReferenceanddemonstratesthechange
inbonedensityassociatedwithaging.Thecenterlineofthebluebariscalleda
regressionline.TheregressionlineshowstheexpectedBMDatdifferentagesfora
particularmeasurementsite.ThebluebarrepresentstheexpectedAge-MatchedBMD
±1standarddeviationforagivenpatient.

Age-MatchedReference

enCOREfactorsintwovariableswhichaffecttheregressionline:

●WeightAdjustment:BodyweightismoderatelyassociatedwithBMD(r=~0.3).

Asweightincreasesordecreases,bonedensitygenerallyincreasesordecreases
proportionally.Foreverykilogramofweightaboveorbelowtheaverageweight
formen(78kg)andwomen(65kg),theexpectedBMDisadjustedby0.004forAP
spineBMDand0.003forfemurBMD.Thisweightadjustmentisappliedforweights
between25and100kg.Weightadjustmentsareappliedtoage-matchedvalues
(Z-Score)only.Youngadult(T-Score)valuesarenotaffected.Ifthesamepatient
weighs90kginsteadof45kg,theblueregressionbarshiftsupwardwhilethe
patient'sBMDisunchanged.Inotherwords,theage-matchedweightadjustment
increasedthepatient'sexpectedBMD.TheWeightAdjustmentoptionisturnedon
oroffinTools>UserOptions>ReferenceData.

●EthnicAdjustment:TheEthnicAdjustment,liketheWeightAdjustment,only

affectstheage-matchedregressionbar .Youngadultvaluesarenotaffected.The
ethnicadjustmenttakesethnicoriginintoconsiderationforthenalage-matched
comparison.Theprogramautomaticallyshiftstheage-matchedregressionbar
upordownaccordingtoethnicoriginifthisoptionisturnedonoroffinTools>
UserOptions>ReferenceData.

81

X-rayBoneDensitometerwithenCOREv17software-UserManual

MeasurementandAnalysis

ReferenceResults

enCOREmaybeconguredtodisplaytheWorldHealthOrganization(WHO)or
JapaneseSocietyforBoneandMineralResearch(JSBMR)barsinTools>UserOptions
>ResultsDisplaytab>ReferenceGraphOptions.Thisoptionlabelsthegraphwith
thedifferentWHOorJSBMRclassications;Normal,Osteopenia,andOsteoporosis.

Useofthereferencepopulationcomparisonsisfullyatthediscretionoftheclinician.
TheprogramdoesNOTshowthecomparativereferencevalueswhenshippedfrom
GEHealthcare.

Referenceresultsincludethereferencegraphandreferenceresultstable:

●Referencegraph:SelecttheDensitometryResultstabtoviewthereferencegraph.

TheReferencegraphshowsthepatient'sT-ScoreandZ-Scoreresults.

●Referenceresultstable:TheresultstableshownbelowtheReferencegraph

givestheresultsforeachregionanalyzed.Toviewtheresultsforaregiononthe
Referencegraph,highlighttheregion.

BMDvaluesshouldbeconsideredtogetherwithotherriskfactors(lowbody
weight,fracturehistory,corticosteroiduse,useoflong-actingtranquilizers,history
offalling)inthepatientevaluation.Inparticular,patientswithapriorhistoryof
osteoporoticfractureshouldbeconsideredtohavedoubletheriskoffuture
fractureatanydensitylevel.

82

X-rayBoneDensitometerwithenCOREv17software-UserManual

PatientTrending

TrendingGraphs

MeasurementandAnalysis

enCOREprovidesamonitoringtooltoviewchangesinapatient'sBMDovertime.To
viewtrendingresults,1)allofthetrendedmeasurementsmustbefromthesamesite,
and2)eachtrendedmeasurementmustbeanalyzed.

Scanswithmixedpositioningand/oranalysismaynotbetrendedtogetheronall
graphs.

SelecttheTrendResultstabtoviewpatienttrendinginformation.
Eachmeasurementisshownasaseparatesquareonthegraph.Adotisshown

inthesquarethatrepresentsthecurrentimage.Trendgraphscanbecongured
aspercentchangeorreference.

Tochangethegraphdisplay,gotoTools>UserOptions>Trendingtab.Referto

Options(236)forinformationaboutconguringUserOptions.

Scanswithmixedpositioningand/oranalysismaynotbetrendedtogetheronall
graphs.ReferenceOnlyTrendGraphs(enabledinTools>UserOptions>Results
Displaytab>ReferenceGraphOptionsbutton>Graphsection)allowmixedanalysis
orpositionerexamsonthesametrendgraph(noBMDdependency).

PercentChangeTrendGraph

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ReferenceTrendGraph(BMDandreference)

ReferenceOnlyTrendGraph(noBMDdependency)

TrendingResultsTable

Thetrendingresultstableisshownbelowthetrendinggraph.Thetablegivesthe
dateofthemeasurement,thepatient'sage,theBMDforthemeasurement,and
thechangeinBMD.

TrendinginformationisshownfortheregionhighlightedintheDensitometrytable.To
changetheregion,highlightanewregionandselecttheTrendtab.

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OneScan

OneScanperformsanAPSpineandDualFemurexamwithoutrepositioningbetween
scans.OneScandoesnotusethefoamlegblockpositionerforspinepositioning.

TurningOneScanOnandOff

TheOneScanoptioncanbedefaultedonoroffthroughTools>UserOptions>
Measuretab.

Apausemaybeenabledtooccurbetweenfemurs(DualFemur)orbetweenAPSpine
andFemurscans.SeeOneScanMeasurement(85).

ThePositionscreenalsoincludesaOneScancheckbox.Ifthisisselected,andthe
patienthashadapreviousscan,thesoftwarewillauto-selectthematchingOneScan
optionfortrending.

DetermineiftheOneScanfeaturewasonoroffthroughexaminationoftheanalysis
screenundertheInformationtab.

OneScanMeasurement

MeasurementandAnalysis

ThepositioninggraphicsaretieddirectlytothecongurationoftheOneScancheck
box.

OneScanisintendedtobeusedwithoutthelegblock.

Thescreenchangesslightly,dependinguponwhethertheOneScanboxischecked.

OneScanon

IfyouareusingOneScan,positionthepatientasfollows:

1.Helpthepatientontothescannertableandpositionthepatientinthecenter
ofthescantable.

OneScanoff

2.Usethecenterlineonthetableasareferencetoalignthepatient.Thepatient's
armsshouldbecrossedoverthechest,awayfromthesideofeachhip.

3.Alignthecenterlineonthescannertablewiththeguideonthebaseofthefoot
brace.

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4.Internallyrotatethepatient'slegs,andsecurethepatient'sfeettothefootbrace.
Itissuggestedthatyoudonotremovethepatient’sshoes.

DuringacombinedAPSpineandDualFemur(orsinglefemur)measurement,the
softwareimmediatelyproceedstothefemursetup.WiththeOneScanfeature
enabled,thesoftwareproceedsdirectlytothepositioningscreenforadjustment
ofthelaserlightposition.TheOneScanfeatureeliminatesthispause,asthe
patientisalreadypositionedwiththeirfeetintheDualFemurbraceforfemur
measurements.

Apausemaybeenabledbetweenscans.ThisoptionisfoundinTools>User
Options>Measuretab.Checkthedesiredoptions.

APSpineMeasurementandAnalysis

APSpinemeasurementandanalysisprovidesanestimateofbonemineraldensity
forthelumbarspine.Thesevaluescanthenbecomparedtoanadultreference
populationatthediscretionofthephysician.

APSpineMeasurement

ThepositioningrequirementsforanAPSpinemeasurementdependonwhetheryou
havechosenOneScaninTools>UserOptions>Measuretab.

●IfOneScanischeckedforaspecicmeasurement,donotusethefoamblock

●IfOneScanisnotcheckedforaspecicmeasurement,besuretousethefoam

ForOneScanmeasurements,theT-Scorecalculationassumesthefoamblockisnot
used.

1.Positionthepatient.

positioner.

blockpositioner.

Ifyouareusingthefoamlegblockpositioner:
a.Helpthepatientontothescannertableandpositionthepatientinthecenter

ofthescantable.

b.Usethecenterlineonthetableasareferencetoalignthepatient.

Thepatient'sarmsshouldbeonthescannertable,alongsidethepatient's
body.

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Removethefoamlegblockpriortopositioningthescanarmand
immediatelyaftertheAPSpinescan.

c.SelectPositionfromtheNewMeasurementtoolbar.

Thescannerarmmovestotheapproximatestartposition,andagraphicis
shownthatgivesthecorrectpatientpositionandmeasurementstartposition.

d.Usethefoamlegblocktoelevatethepatient'slegs.Makesurethepatient's

thighsforma60°to90°anglewiththetabletop.Thisstephelpsseparate

vertebraeandattenthelowerback.
Ifyouarenotusingthefoamlegblockpositioner(OneScan):
a.Helpthepatientontothescannertableandpositionthepatientinthecenter

ofthescantable.
b.Usethecenterlineonthetableasareferencetoalignthepatient.

Thepatient'sarmsshouldbecrossedoverthechest,awayfromthesideof

eachhip.

c.SelectPositionfromtheNewMeasurementtoolbar.

Thescannerarmmovestotheapproximatestartposition,andagraphicis

shownthatgivesthecorrectpatientpositionandmeasurementstartposition.
d.Usethecenterlineonthescannertableasareferencetomakesurethefoot

braceiscentered.
e.Alignthecenterlinewiththeguideonthebaseofthefootbrace.Internally

rotatethepatient'slegs,andsecurethepatient'sfeettothefootbrace(itis

recommendedthatyoudonotremovethepatient'sshoes).

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2.SelecttheappropriatescanmodebasedonthethicknessoftheAPSpinearea.
ThescanmodefortheAPSpinemaybedifferentthanthescanmodeusedfor

thefemur,basedonthepatient'sweightdistribution.

3.Adjustthepositionofthelaserlight.Positionthelaserlightapproximately5cm
belowthepatient'snavelandinthesamelongitudinalplaneasthepatient's
midline.

4.Tostartthemeasurement,selectStartfromtheNewMeasurementtoolbar

5.Monitortheimagetomakesureitiscorrect.Makesurethat:

●Thespineisinthecenteroftheimage

●(1)AllofL4(1)isshown

●(2)ThetopofL5(2)isshownintherst1-2sweepsforiDXAandProdigy

scanners

●(2)ThetopofL5(2)isshownintherst5-15scanlinesforDPXscanners

●(3)Approximately1/2ofT12isshown

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6.Iftheimageisnotcorrect,selectAbort,repositionthelaserlight,andrestart
themeasurement.

7.Tocompleteanothermeasurementforthepatient,selectSetUpfromtheNew
Measurementtoolbar.

8.Ifyouhavecompletedmeasurementsforthepatient,selectHometomovethe
scannerarmtotheHomeposition

9.SelectAnalyzetoproceedtoAnalysis,orClosetoexittheMeasurementscreen.

APSpineAnalysis

1.Ifanimageisnotalreadyopen,selectanimageleforanalysis.

TheresultsmayincludeaScanChecktab.UseScanCheck

(183)toassistintheanalysisoftheimageandtohelpyou

makecorrectionswherenecessary.

2.Ifnecessary,selectImagingfromtheAnalysistoolbartoadjusttheimage.

3.Ifnecessary,selectROIsfromtheAnalyzetoolbartoadjusttheROIs.
enCOREsoftwarewillplacetheROIscorrectlymostofthetime.Donotmake

adjustmentstotheanalysisunlessthereisanobviousadjustmentneeded.
Makesurevertebraearecorrectlyidentiedandintervertebral(IV)markersare

betweenthevertebralbodies(1)andlocatedatthelowestpointofbonedensity
asindicatedontheboneprole(2).

Analysisresults

4.IfyouneedtoadjustROIsforanAPSpineimage,usethesetools:

Icon

Tool

AddROISelectAddROItoaddanROIduringAPSpine

Description

analysis.WhenyouaddanewROI,itisinserted
belowtheROIthatisselectedontheimage.
SelectLabelROItolabeltheROIsaccordingly.

DeleteROISelectDeleteROItoremoveanROIduring

APSpineanalysis.ClicktheROI,thenselect
DeleteROI.SelectLabelROItolabeltheROIsif
necessary.

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Icon

Tool

MoveROI

RotateROI

LabelROIsSelectLabelROIstorelabelROIsafteryouhave

ExcludeROIsThistoolletsyouremoveROIsfromAPspine

Show/HideScanCheck
Markers

Description

SelectMoveROItomoveROIs.

SelectRotateROItorotateanROI.

addedordeletedanROIfromanimage.

results.
SelectExcludeROI,andthenselecttheROIs

youwanttoexcludefromanalysis.Parentheses
appeararoundtheROIlabelsofexcludedROIs.

ResultsforindividualROIsareshownevenifthe
ROIsareexcludedfromanalysis.ExcludedROIs
arenotincludedintheresultsforcombinations
ofvertebrae.

Thistoolletsyoushow/hideScanCheckmarkers
thatindicateapossiblehighdensityarea,such
asanartifactorosteophyte.

ScanCheckMarkersisavailableonlyifScanCheck
isenabled.

5.IfyouadjustROIs,selectResultstoviewtheanalysisresults.

6.Ifyouneedtoadjustpointtyping,selectPointsfromtheAnalyzetoolbar.
Donotadjustthepointtypingunlesstheprogrammadeobviouserrors.

7.Ifyouadjustpointtyping,selectResultstoviewthenewanalysisresultsbased
onyourchanges.

Bonepoints

Neutralpoints

Tissuepoints

8.SelectSavetosaveyourchanges,orselectClosethenNoifyoudonotwant
tosaveyourchanges.

RefertoCustomAnalysisProcedures(180)andEstimatedTotalBodyFatand

Android/GynoidFat(129)foradditionalanalysisinformation.

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Femur/DualFemurMeasurementandAnalysis

Femur/DualFemurmeasurementandanalysisprovidesanestimateofbonemineral
densityfortheproximalfemur.Thesevaluescanthenbecomparedtoanadult
referencepopulationatsolediscretionofthephysician.

Femur/DualFemurMeasurement

1.Helpthepatientontothescannertableandpositionthepatientinthecenterof
thescantable.Usethecenterlineonthetableasareference.

Thepatient'sarmsshouldbecrossedoverthechest,awayfromthesideof
eachhip.

MeasurementandAnalysis

2.SelectPositionfromtheNewMeasurementtoolbar.
Thescannerarmmovestotheapproximatestartposition,andagraphicisshown

thatgivesthecorrectpatientpositionandmeasurementstartposition.

3.Usethecenterlineonthescannertableasareferencetomakesurethefootbrace
iscentered.Alignthecenterlinewiththeguideonthebaseofthefootbrace.
Internallyrotatethepatient'slegs,andsecurethepatient'sfeettothefootbrace
(itisrecommendedthatyoudonotremovethepatient'sshoes).

4.Selecttheappropriatescanmodebasedonthethicknessofthefemurarea.
Thescanmodeforthefemurmaybedifferentthanthescanmodeusedforthe

APSpine,basedonthepatient'sweightdistribution.

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5.Adjustthepositionofthelaserlight.Positionthelaserlightapproximately7-8cm
belowthegreatertrochanterwherethetransverse(PubicSymphysis)andmidline
ofthefemurintersect.

IfyouareperformingaDualFemurmeasurement,positionthelaserlightfor
theleftfemurrst.

6.Tostartthemeasurement,selectStartfromtheNewMeasurementtoolbar

7.Monitortheimagetomakesureitiscorrect.Makesurethat:

●TheFemurimageshowsthegreatertrochanter(1),femoralneck(2),and

ischium(3).

●Aminimumofthreecentimetersoftissueshouldbeshownabovethegreater

trochanterandbelowtheischium.

8.Iftheimageisnotcorrect,selectAbort,repositionthelaserlight,andrestart
themeasurement.

9.IfyouareperformingaDualFemurmeasurement:
DualFemurletsyoumeasurethepatient'sleftandrightfemurinanautomatic

sequence.Aftertheprogramhasmeasuredtheleftfemur,thescanarmmoves
totheapproximatestartpositionfortherightfemur.

Checkthestartpositionand,ifnecessary,adjustthemeasurementstartposition
fortherightfemur.

10.DPX-DuoandDPX-Bravohaveanarrowscanregion.Therefore,repositioningthe
patientforthecontra-lateralfemurmaybenecessary.

11.Tocompleteanothermeasurementforthepatient,selectSetUpfromtheNew
Measurementtoolbar.

12.Ifyouhavecompletedmeasurementsforthepatient,selectHometomovethe
scannerarmtotheHomeposition

13.SelectAnalyzetoproceedtoAnalysis,orClosetoexittheMeasurementscreen.

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AtypicalFemurFractureMeasurement

IfyoupurchasedtheAtypicalFemurFracture(AFF)optionforyourbonedensitometer,
AFFfeaturesappearintheenCOREsoftware.

AFFmeasurementandanalysisprovidesanx-rayimageoftheentirefemurforboth
qualitativevisualassessmentandquantitativemeasuresinordertoidentifyareasof
focalthickeningalongthelateralcortexofthefemoralshaft.Youcanalsogetbone
mineraldensityvaluesfortheproximalfemuroftheAFFmeasurement.

1.Helpthepatientontothescannertableandpositionthepatientinthecenterof
thescantable.Usethecenterlineonthetableasareference.

Thepatient'sarmsshouldbecrossedoverthechest,awayfromthesideof
eachhip.

MeasurementandAnalysis

2.SelectPositionfromtheNewMeasurementtoolbar.
Thescannerarmmovestotheapproximatestartposition,andagraphicisshown

thatgivesthecorrectpatientpositionandmeasurementstartposition.

3.Usethecenterlineonthescannertableasareferencetomakesurethefootbrace
iscentered.Alignthecenterlinewiththeguideonthebaseofthefootbrace.
Internallyrotatethepatient'slegs,andsecurethepatient'sfeettothefootbrace
(itisrecommendedthatyoudonotremovethepatient'sshoes).

4.Selecttheappropriatescanmodebasedonthethicknessofthefemurarea.
Thescanmodeforthefemurmaybedifferentthanthescanmodeusedforthe

APSpine,basedonthepatient'sweightdistribution.

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5.Adjustthepositionofthelaserlight.Thelaserlightpositionforafemur
measurementdependsonwhetheryouhavechosentoperformdistaland
proximalscansforAFF.

ForAFFmeasurementsofboththedistalandproximalfemur,positionthelaser
lightsoitiscenteredonthepatella.

IfyouareperformingaDualFemurmeasurement,positionthelaserlightforthe
leftfemurrst.

6.Tostartthemeasurement,selectStartfromtheNewMeasurementtoolbar

7.Monitortheimagetomakesureitiscorrect.Makesurethat:

●TheFemurimageshowsthegreatertrochanter(1),femoralneck(2),and

ischium(3).

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●Aminimumofthreecentimetersoftissueshouldbeshownabovethegreater

trochanter.

8.Iftheimageisnotcorrect,selectAbort,repositionthelaserlight,andrestart
themeasurement.

9.AFFmeasurementsareperformedasasequenceoftwoexposures.Afterthe
programhasmeasuredthedistalfemur,apromptisdisplayedtostartthe
measurementoftheproximalfemur.

10.IfyouareperformingaDualFemurmeasurement:
DualFemurletsyoumeasurethepatient'sleftandrightfemurinanautomatic

sequence.Aftertheprogramhasmeasuredtheleftfemur,thescanarmmoves
totheapproximatestartpositionfortherightfemur.

Checkthestartpositionand,ifnecessary,adjustthemeasurementstartposition
fortherightfemur.

11.Tocompleteanothermeasurementforthepatient,selectSetUpfromtheNew
Measurementtoolbar.

12.Ifyouhavecompletedmeasurementsforthepatient,selectHometomovethe
scannerarmtotheHomeposition

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13.SelectAnalyzetoproceedtoAnalysis,orClosetoexittheMeasurementscreen.

Femur/DualFemurAnalysis

1.Ifanimageisnotalreadyopen,selectanimageleforanalysis.

2.Ifnecessary,selectImagingfromtheAnalyzetoolbartoadjusttheimage.

3.Ifnecessary,selectPointsfromtheAnalyzetoolbartoadjustpointtyping.

WhenyouopenaDualFemurimageforanalysis,theleftandrightfemurimages
arebothshown.Theactivefemurhasablueboxarounditsimagewindow.Click
insideanimagewindowtomakethatfemurimagetheactiveimage.Theresults
includeBMDvaluesforeachregionofeachfemurandaveragesanddifferences
betweenfemurs.Referencedataandtrendingareavailable.

TheresultsmayincludeaScanChecktab.UseScanCheck

(183)toassistintheanalysisoftheimageandtohelpyou

makecorrectionswherenecessary.

Bonepoints

Neutralpoints

Tissuepoints

Donotadjustthepointtypingunlesstheprogrammadeobviouserrors.

4.Ifyouadjustpointtyping,selectResultstoviewtheanalysisresultsbasedon
yourchanges.

5.Generally,noadjustmentsarenecessarytoROIplacement.
Donotadjust(move,rotate,orsize)theNeckROIunlessitisobviouslyincorrect.
TheNeckROIshouldbepositionedasfollows:

●TheNeckROIincludesnopartofthegreatertrochanter

●TheNeckROIincludessofttissueoneithersideoftheneck

●TheNeckROIisperpendiculartothefemoralneck

●TheNeckROIcontainslittleornoischium(iftheischiumisincludedintheNeck

ROI,theprogramautomaticallyassignsthebonewithintheischiumasNeutral)

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ItisnotrecommendedthatyouadjusttheNeckROI.

MeasurementandAnalysis

a.Ifitisnecessarytoperformfurtheradjustments,selecttheROItoolfromthe

Analysistoolbartocompletetheseprocedures:

●SelecttheSearchtooltopositiontheneckROIcorrectly.Searchlocatesthe

regionofthelowestBMDandmostnarrowareaoftheneck.

●Move:UsethecursortoselectandmovetheNeckROIandtheNeckAxis.

●Rotate:UsethecursortoselectandrotatetheNeckROIandtheNeckAxis.

●Size:SelecttheSizetool.Usethecursortoincludetissueoneithersideof

theneckifnoneispresent.NeveredittheNeckROIwidth.

6.SelectResultstoviewtheanalysisresults.

7.SelectSavetosavechanges.
RefertoEstimatedTotalBody%FatandAndroid/Gynoid%Fat(129),Advanced

HipAnalysis(106),orFRAX10-YearFractureRisk(97)foradditionalanalysis

information.

FRAX10-YearFractureRisk

FRAX10-YearFractureRiskprovidesanestimateof10-yearprobabilityofhipfracture
and10-yearprobabilityofamajorosteoporoticfracture(clinicalspine,forearm,hip,or
shoulderfracture)formenandpost-menopausalwomenages40-90years.

Thisestimateisbasedonthepatient’sage,gender,population,ethnicity,height,
weight,femurneckBMDT-score,andthepresenceorabsenceofseveralriskfactors.It

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iscomputedusingtheFRAXmodelendorsedbytheWorldHealthOrganization(WHO).
T-scoresarebasedontheNHANESreferencevaluesforwomenaged20-29years.

Thephysicianshouldreviewlocalclinicalguidelines,andthendeterminetheoptimal
FRAXconguration.

FRAXisatrademarkoftheUniversityofShefeldMedicalSchool,CentreforMetabolic
BoneDiseases,AWorldHealthOrganization(WHO)CollaboratingCentre.

EnablingandConguringFRAX

ToenableFRAX,selectTools>UserOptions>SystemtabandclickFRAX.

FRAXdialog

CongureFRAXaccordingtositeneeds.Youcanchooseto:

●Alwayscalculateapatient’sfracturerisk(checkEnableFRAX)

●CalculateFRAXaccordingtoNOF/ISCDrecommendations(checkEnableFRAXand

ApplyU.S.NOF/ISCDFRAXRecommendations)

●NevercalculateFRAX(clearbothcheckboxes)

Thedefaultisbothboxesunchecked.

FRAX10-YearFractureRiskCalculation

TheFRAXtabisavailableduringLeftFemur,RightFemur,andDualFemuranalysis.
RefertothisgurewhenfollowingthestepsbelowtocalculateFRAX10-Year

ProbabilityofFracture.

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FRAXriskcalculation

1.Checktheappropriateriskfactors,accordingtotheseguidelines:

MeasurementandAnalysis

RiskFactorsSelectriskfactorifthepatient:

Alcohol(3ormoreunits
perday)

Takes3ormoreunitsofalcoholdaily.Thisis
equivalenttoastandardglassofbeer(285ml),a
singlemeasureofspirits(30ml),amedium-sized
glassofwine(120ml),or1measureofanaperitif
(60ml)

FamilyHist.(Parenthip
fracture)

Glucocorticoids
(Chronic)

Hasahistoryofhipfractureinthepatient's
motherorfather

Isexposedtooralglucocorticoidsorhasbeen
exposedtooralglucocorticoidsformorethan3
monthsatadoseofprednisoloneof5mgdailyor
more(orequivalentdosesofotherglucocorticoids)

HistoryofFracture
(Adult)

Hasapreviousfractureinadultlifeoccurring
spontaneously,orafracturearisingfromtrauma
which,inahealthyindividual,wouldnothave
resultedinafracture

SecondaryOsteoporosisHasadisorderstronglyassociatedwith

osteoporosis.TheseincludetypeI(insulin
dependent)diabetes,osteogenesisimperfectain
adults,untreatedlong-standinghyperthyroidism,
hypogonadismorprematuremenopause(<45
years),chronicmalnutrition,ormalabsorptionand

chronicliverdisease
RheumatoidArthritisHasaconrmeddiagnosisofrheumatoidarthritis
TobaccoUser(Current

Currentlysmokestobacco
Smoker)

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2.ChecktheappropriateNOF/ISCDFilters,accordingtotheseguidelines:

NOF/ISCDFilters

OnTreatment

PreviousFracture(Hip
orSpine)

Description

Examplesof“OnTreatment”patientsinclude:

●Estrogen/HormoneTherapyorSERMwithinthe

pastoneyear

●Calcitoninwithinthepastoneyear

●ParathyroidHormone(PTH)withinthepastone

year

●Denosumabwithinthepastoneyear

●Bisphosphonatewithinthepasttwoyears

(unlessitisanoraltakenfor<2months)

Calciumandvitamin
DdoNOTconstitute
“OnTreatment”inthis
context.

Priorhiporvertebralfracture(clinicalor

morphometric).

3.DualFemurmeasurementsautomaticallyselecttheregion(LeftorRight)withthe
lowestfemoralNeckBMD(lowest).Youcanchangethisselectionbyclickingon
theregionofchoice(Left,Right,orMean).

4.SelecttheappropriateFRAXPopulationfromthedropdownmenu.Ifthepatient's
countryisnotrepresented,selectthecountryforwhichtheepidemiologyof
osteoporosismostcloselyapproximatesthepatient'scountry.

BasedontheFRAXmodel,examplesofhighriskcountriesareDenmarkand
Sweden.LowriskcountriesincludeLebanonandChina.

5.ClicktheCalculatebutton.
The10-yearprobabilityofhipfractureand10-yearprobabilityofamajor

osteoporoticfracturearedisplayed.

FRAX10-YearFractureRiskReports

ThefollowingFRAX10-YearFractureRiskreportsareavailable:

Composer
DXAreports

FRAX
DualFemurFRAX,LeftFemurFRAX,andRightFemurFRAX

(availabilitybasedonopenexam).

RefertoCreatingaReport(193)andDXAResultsReports(191)formoreinformation
ongeneratingreports.

AtypicalFemurFractureAnalysis

AtypicalFemurFractures(AFFs)arestressfracturesthatoccurinthefemurshaftand
maybeaccompaniedbyafocalordiffuseperiostealreactionofthelateralcortex
surroundingtheregionwherethefractureinitiated.Anareaofcorticalthickeningis
calleda“beak”,andtheprocessofthethickeningiscalled“beaking”.

AtypicalFemurFracture(AFF)Analysisdisplaysanimageoftheentirefemurtoallow
theusertovisualizefocalreactionorthickeningofthelateralcortex.Inaddition,the

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