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1. 1 Trending graphs Select Trend from the Results tabs to graph patient trending information according to Percent Change or Reference Each measurement is shown as a separate square on the graph A dot is shown in the square that represents the current image To change the graph display go to Tools User Options Trending tab Refer to the topic Options for configuring User Options Page 117 of 138 2 Trending results table The trending results table is shown below the Trending graph The table gives the date of the measurement the patient s age the BMD for the measurement and the change in BMD Trending information is shown for the region highlighted in the Densitometry table To change the region select the Densitometry tab highlight a new region and select the Trend tab 4 22 Precision Calculator 4 22 1 Precision Calculator Recommendations The following are recommendations to assist in optimizing enCORE s Precision Calculator interface to find your facility s DXA precision error If you need to acquire scans for your precision study be aware that local regulatory policies often apply to such studies Please consult the appropriate regulatory body for more information The International Society for Clinical Densitometry www iscd org is a good resource for information on precision and bone densitometry 1 Create a new database to be used for your study scans only Select the New Database tool in the left panel b
2. AT ALL TIMES let the program perform the analysis unless the scan image obviously must be corrected 4 1 Basic analysis procedures Note The results tabs for AP Spine Femur Forearm and Total Body images include a ScanCheck computer assisted densitometry The list of Yes No questions should be used to assist in analysis There is a space for comments You can print the checklist by selecting to print ScanCheck in the Report Center Refer to ScanCheck Section for more information 4 1 1 Select Image 1 From the Main screen select Analyze From the Directory screen select the patient from the Patient list Use the Search option to locate a patient in a large database 2 Select the image to analyze from the Image list 3 Select OK or the Analyze button from the directory screen 4 enCORE typically performs the analysis automatically Do not change ROls or Point Typing unless the analysis shows an obvious need for corrections 4 1 2 Adjust Image R Select Imaging from the Analyze toolbar to adjust the image the Image Tools window is shown Use this window to change the gray levels of the image and zoom the image Image Tools Window The Image Tools window shows a bone profile and gives the options that follow e Brightness To adjust the brightness for the image click and drag the brightness scroll bar right or left Select OK e Contrast To adjust the contrast for the image click and drag the contrast scroll bar right or le
3. Note These recommendations apply only to the US Review these guidelines at NOF or ISCD web sites Page 122 of 138 4 24 2 FRAX 10 Year Fracture Risk Calculation The FRAX tab is available during Left Femur Right ScanCheck Densitometry FRAX Composition AHA Information Femur and e a DualFemur LA Risk Factors 1 5 10 year Probability of Fracture analysis Me Using the image Alcohol 3 or more units per day follow steps 1 4 to calculate FRAX 10 M Famil Hist Parent hip fracture Year Probability of Fracture Glucocorticoids Chronic A FRAX Population i History of Fracture Adult USA Caucasian Secondary Osteoporosis 3 Based on femal neck EMD Rheumatoid Arthritis C Left 0 891 g cm Tobacco User Curent Smoker Right lowest 0 788 g cm i NOF ISCD Filters D f Mean 0 840 g cm On Treatment Previous Fracture Hip or Spine 1 Click the boxes next to the listed risk factors to place a check mark in the appropriate risk factors Use the table below to determine if risk factor should be selected for a patient Risk Factors Select risk factor if the patient Alcohol 3 or more units per day Family Hist Parent hip fracture Glucocorticoids Chronic History of Fracture Adult Secondary Osteoporosis Rheumatoid Arthritis Tobacco User Current Smoker Takes 3 or more units of alcohol daily This is equivalent to a standard
4. 4 Select OK Follow the screen prompts to complete the QA procedure 5 If the QA test did not pass reposition the calibration block and repeat the procedure If the procedure fails a second time call Lunar Support for assistance 6 To print the QA results select Report if the auto print option is not set Save the QA printout Page 34 of 138 2 0 2 Quality Assurance Options Go to Tools User Options QA tab Click here or go to the Options chapter 2 0 3 Graphical Interface Startup Database Validation Test Scanner Self test QA Block Search Peaking Mechanical Beam Stop Test Transverse Distance Longitudinal Distance X ray Spectrum Spillover Detector Reference Counts Detector Status Calibration BMD values of High Medium and Low block chambers Tissue values of Lean Normal and Fat block values Trend analysis Phantom BMD BMC Area Edge detection Click on the Trend tool to exit out of the QA process screen 2 0 4 QA Trend Reporting Options Click on Settings The settings screen provides many options for QA trend reporting components In the upper right panel are options for the QA Report Type e QA Phantom Report e Ancillary page e Legacy QA Report GE E ue D GG Helter eid ei T apl THL i mr ml a It prp T i i E Hott it tij Page 35 of 138 QA Phantom Report ia ae Ei Li CESE A i am is ell egeeg Di B AN Bann K gt E biei es WH S
5. Optional Advanced Hip Assessment Software provides a measurement of hip axis length HAL and a mean value of HAL for Caucasian and Asian females on femur images It also calculates hip geometry values used to evaluate the structural properties of the hip The DPX Duo model has special mechanical features including stirrups storage drawers and patient step to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table Device Descriptions Structure The X Ray Bone Densitometer is made up of a scan arm X ray source assembly and exam table Each model is described in more detail below The scan arm control panels for each model are described in scan arm control panel section Product Model DPX Bravo and Duo Page 7 of 138 The DPX Bravo and Duo models use pencil beam technology with a single crystal detector and have a compact table design to provide space efficiency See images below The DPX Duo and the DPX Bravo come equipped with a scan arm that swings to the side of the table when not in use when not in use as a densitometer and to facilitate patient loading X ray scanning is not possible until the scan arm is locked into the scan position A handle releases the scan arm interlock and allows operator to move the scan arm for patient loading Once the patient is loaded on the table the operator moves the scan arm back to scanning position and the arm locks into scan posit
6. Ensure the cuts separate the hands and arms from the body 3 Left and right forearm Both forearm cuts are as close to the body as possible and separate the elbows and forearms from the body 4 Left and right spine Both spine cuts are as close to the spine as possible without including the rib cage 5 Left and right pelvis Both pelvis cuts pass through the femoral necks and do not touch the pelvis 6 Pelvis top The Pelvis Top cut is immediately above the top of the pelvis 7 Left and right leg Both leg cuts separate the hands and forearms from the legs 8 Center leg The Center Leg cut separates the right and left leg If necessary select ROIs and the Move Vertex tool Adjust the cut itself or select a vertex to adjust the cut position Select Results to view the analysis results Icon Tool Description Move This tool is shown when you select ROIs Select the Move Vertex a Vertex tool if it is necessary to position ROI vertices e Vertex Use the left mouse button to click on a vertex then drag the cursor the cursor is shown as a circle to indicate the vertex is selected e Cut Use the left mouse button to click on a cut not a vertex then drag the cursor 4 If necessary select Points to examine point typing DO NOT adjust the point typing unless the program made obvious errors If you adjust point typing select Results to view the analysis results based on your changes A Use the Adjust Image Thresh
7. Image Image tool to activate mouse control to zoom in or out on the image Pan If you zoom the image larger than the viewable area Image on the screen use the Pan Image tool to view hidden areas of the image Select the Pan Image tool then drag the cursor to move the image Zoom Move the cursor over the image and use the Zoom Image Image bar to zoom in or out on the image L 4 1 3 Advanced Adjust ROIs ROls do not need to be adjusted in most circumstances The procedures for adjusting ROI position are specific to each measurement site Caution Some ROI adjustments will render the results unreliable See the specific scan type recommendations for analysis 4 1 4 Advanced Adjust Point Typing enCORE analysis automatically assigns point typing to a scan and usually requires no adjustment Significant changes to Point Typing will affect both the results and reproducibility of a scan The procedures that follow give instructions to examine and adjust point typing for an image only Artifact point typing can be adjusted for Total Body analysis DO NOT adjust the point typing unless the program has made obvious errors Change the point typing only if the area that needs to be changed is larger than the default cursor size It is recommended that changes be limited to Bone and Neutral point typing A tool that lets you 1 view how the program classified the sample points and 2 change the classification if necessary The poin
8. Index Advanced Hip Analysis AHA 73 Analysis Overview 64 Analysis Procedures 65 AP Spine Analysis 68 APVA Morphometry Analysis 70 APVA Spine Geometry Analysis 70 Archive 134 Batch Exam File Operations 143 Composer Reports 114 Composition Analysis 79 Compress Database 132 Copy Exam File 138 Custom Analysis 124 Custom Reference Population 107 Database 131 Delete Database 132 Delete Patient 139 Directory Screen 21 DXA Results 120 External USB Hard Drive 140 Femur Analysis 72 Forearm Analysis 98 FRAX 10 Year Fracture Risk 126 Hand Analysis 100 Image change type 139 Importing 135 Lateral Spine Analysis 89 LVA Morphometry Analysis 90 LVA Spine Geometry Analysis 97 Maintenance 131 Maintenance Procedures 131 Measurement 39 Measurement Procedures 42 Move 137 New Database 133 OnesScan 57 OneVision 59 Options 26 Orthopedic Hip Analysis 101 Orthopedic Hip Measurement 60 Pediatric 57 Pediatric Analysis 102 Practice Management Tools 111 Precision Calculator 122 Quality Assurance 36 Quick View 62 Rebuild Database 134 ScanCheck 108 Screens Toolbars 16 Small Animal Analysis 105 Spine Phantom Procedure 62 SQL Database Interface 140 Task Scheduler 143 Total Body Analysis 77 Page 138 of 138
9. Measure A pause may be enabled to occur between femurs DualFemur or between AP Spine and Femur scans See OneScan Measurement below The Position screen also includes a OneScan checkbox If the patient has had a previous scan the software will auto select the matching OneScan option for trending Determine if the OneScan feature was on or off through examination of the analysis screen under the Information tab 3 4 2 Positioning the Patient The positioning graphics are tied directly to the configurable OneScan checkbox The graphics will change slightly depending upon the configuration selected Graphics OneScan ON Graphics OneScan OFF Dap spre L on Femur be Fema cee BaP spine ELo Femur EFi Fem Lege Rotated inward ed ee a ee JI WE Center and Squaie Shosi Shiapped Dech Cenim and Square D Atert Lass Light Positioning the patient remains the same if you choose to not use the OneScan option However if you are using OneScan the following positioning should be utilized 1 Help the patient onto the scanner table and position the patient in the center of the scan table Use the centerline on the table as a reference to align the patient 2 The patient s arms should be crossed over the chest away from the side of each hip 3 Align the centerline on the scanner table with the guide on the base of the foot brace 4 Internally rotate the patient s legs and secure the patient s feet to the foot brace GE
10. Review Import Supported Scan Types for more information Note Corrupted files databases or unanalyzed scan data will not be imported Morphometry Small animal and Hand is not available for import Required Files for Database Import Hologic DOS Hologic Lunar DPX IQ Lunar NT MD Lunar Expert Lunar Prodigy amp Norland Windows DPX MD iDXA Series Patient dbf Patscan mdb Region dbf Lunar mdb Region dbf Lunar mdb XR26 all fil Genscan dbf Scan dbf Scan dbf files additional Pbio dbf Pbio dbf service conversion Page 130 of 138 Create a folder on the enCORE computer directory to hold the import files In enCORE select Directory Database Utilities Import Select the Source Database Click the Browse button and navigate to the folder that holds the import data Import Database source Directory Source Files D datal Browse Copy available source exam files to destination Source Database Language DPX IQ Files dbf English United States Source field for PATIENT_ID ec zer SEH The import files are listed under Source Files Click OK to complete the process Note Large databases may take more than an hour to import Stopping the import process by closing the application or rebooting the system will likely corrupt data 5 9 Move tH Move lets you move image files exams from one patient record to another 1 Select the image file you want to move Select more than one file by holding down the
11. select Abort and reposition the patient 7 amp _ If you have completed measurements for the patient select Home to move the scanner arm to the Home position 8 LN Select Close to exit the New Measurement screen Refer to the topic New Measurement screen for additional screen functions Page 50 of 138 3 2 10 Hand Measurement Option 1 Set the patient in a chair next to the scan table Have the patient place the hand flat on the table 2 cm from the line on the table pad with the thumb and fingers together Note Use a chair without arms or wheels Use the same chair for all hand measurements to get optimal precision Note Lunar iDXA scanners also have an option to scan the patient in a non seated position with the scan positioner under the hand Tools User Options Measure tab Continue to use the same method of positioning If previous scans were done in a seated position continue to use the same scanning method to trend data Non Seated iDXA onl Laser Light In center of wrist adjacent to ulna styloid e Em Ze EE D eS e E E e Position hand 2 cm from the line on the table pad fingers and thumb flat and together Fingers and thumb flat and together 2 5 Select Position from the New Measurement toolbar The scanner arm moves to the approximate start_position For hand measurements be careful that the scanner arm does not bump the patient s head Page 51 of 138 3 Use the graphic sh
12. you can also enter the patient s insurance information This information is not required to complete a measurement Page 38 of 138 3 Select OK when you have finished recording the patient information The New Measurement screen is shown if you started from the Main screen if you started from the Directory screen highlight the patient s name and select Measure from the toolbar to go to the New Measurement screen Select existing patient record Select a patient for a new measurement from either the Main screen or the Directory screen Use the Search option to find the patient if necessary Main screen a Select Measure The Patient Information dialog box is shown b Select Find The Patient and Image lists are shown c Double click on the patient in the Patient list The Patient Information dialog box is shown d Make sure the patient information is correct then select OK The New Measurement screen is shown Directory screen Double click on the patient in the Patient list or highlight the patient and select Measure from the Common toolbar The New Measurement screen is shown 3 2 2 Step 2 Select measurement site The New Measurement screen shows a skeletal image which gives the sites you can select to measure Use the mouse to click on the site you want to measure The site you select is highlighted in the Exam list Information about the measurement modes is located in the Safety Information and Technical Specifications manual
13. 0 200 0 Bone area is substantially different from previous scan Bone area threshold 0 100 AP Spine Anatomy Unusual high density areas detected Detection Sensitivity 1 0 10 0 T Score for an individual vertebra shows an unusual variation from the L1 L4 T Score Average T Score variation threshold 0 0 5 0 T Score for at least one vertebra shows an unusual variation from the T Score of an adjacent vertebra Adjacent T Score variation threshold 0 0 5 0 T Score for at least one vertebra shows an unusual variation from the T Score of another vertebra T Score variation threshold 0 0 5 0 Unusual spine curvature was detected Angle Cobb threshold degree 0 90 Page 105 of 138 Heading Femur shaft does not appear to be aligned properly Angle threshold degree 0 90 NN Poor femur rotation Lesser trochanter visibility threshold mm 0 10 Femur Analysis Bone area is substantially different from previous scan Bone area threshold 0 100 Forearm ScanCheck Heading Forearm Measure Forearm does not appear to be aligned properly Angle threshold degrees 0 90 4 19 Practice Management Tools 4 19 1 Practice Management Tools Option Practice Management Tool is a general purpose business reporting tool for your practice Create a report by selecting Composer Practice Management Tools from the Composer Menu Practice Management Tools includes a list of templates to make the creation of reports with C
14. 1 Basic analysis procedures ssosennneosennneesrenrrnosnnrerennrrenrnnrrersnnreressnnenee 61 4 2 AP Spine AMON y SIS ceeded edeesingeneacnindatecpiostentaiasioneaacecseaeaeseondwedessieacanseaenaneateeads 64 4 3 APVA Morphometry Analyse 66 4 4 APVA Spine Geometry Analysis nnnnn0000nnnnnnnonnannnnnnnonnnnnnnnosennnrereeenene 66 4 5 Femur DualFemur Analysis cccccccccseeeeeeceeeeeeceeseeeesegeeeseeeeeesseeeesaaaeees 68 4 6 Advanced Hip Analysis cccccceccccecceesseeeeeceeeseeeeeeaeeeeeesseaeseeeessaaeeeesenaaees 69 4 7 Total Body ANAly EE 73 4 8 COMPOSITION Analveis 75 4 9 Lateral Spine Analysis cccccccccccccseeeeeeeeeaeeeeeeeeeaeeeeeesseeeecesessaaeeeeeesaaees 85 4 10 LVA Morphometry Analves 86 4 11 LVA Spine Geometry Analyse 93 4 12 Forearm Analysis ccccccccccsseseecceeseeeeeeeeeeeeeeeeeessueeessageeeeseeeeesseneeesaeeeees 94 4 13 Hand Analysis cccccccscscceccseseeeceseeeeseeeeeeseuceeseeneeessaeeeeseaseeesseneeesaegeees 96 4 14 Orthopedic Analysis cccccssessecccceessececcceeeeeeceeeeeeeeseeaeeeeesseasseesesseaees 97 419 COL AUG Eegenen 98 4 16 Small Animal Body Analysis ccccccsssseeeeeeeeeeceeeeeeeeeeeessaeeeeeeeeeeeeseaas 101 4 17 Custom Reference Population cccccccccsseeeeeeeeaeeeeeeeeeaeseeeseaeeeeeseeeas 103 BAG eege 104 4 19 Practice Management Tools ccccseesccccseeeeeeeeeeeeeeeeeeeseneeessenseeeneees 106 4 20 Compose
15. Breaks Text site specific type specific or gender specific category if necessary Select Edit to change a E aP Spine Male Standard Deviation category or Delete to remove one all Age Matched All 4ge Matched Pediatrics Standard Deviation iit H CI Female 3 Select the Text tab Numbered assessment boxes are shown on the assessment graph 4 Select the box for which you want to edit an assessment recommendation or follow up The current assessment recommendation and follow up for that box is shown on the left side of the window 5 Edit the assessment Note GE Healthcare LUNAR provides sample assessments to help write your own assessments The sample assessments begin with the word Sample and will appear on the summary report as a Sample Note Select the Insert Field button to use field codes in the assessment Field codes automatically insert information such as a patient s birth date the BMD of the measured region or today s date into the assessment 6 Recall Date The Composer Report can automatically add the Recall Date indicating the recommended return appointment based an the measurement date and what has been set up in the Assessment Editor screen Select the Recall option in either Year s or Month s Page 111 of 138 Section TAT insert Bell Ja Assessment The BPD measured at lt SteNare gt lt DencRegon gt amp spens gt with a T score of lt Tocore gt a This
16. Ctrl key as you select files 2 Select Move from the Directory toolbar 3 Select the patient record to which you want to move the file Select Change Database if the patient record is located in a different database Page 131 of 138 LE Move Exam Step 1 of 2 Move exam for RedeR 1 to which patient L st Hame e Sach Search retuned 34 out of 34 patients i aC EILS LR OC pamen Al Psients A Janeway Kalhaiina 280748 Lesie Jarice 821730 Lesie Jarice 837210 1552 Feder 1 m2 1 Henx rurak e h Change Database _ Next gt Finish Cancel 4 Select Next 5 Select Yes or No to replace the patient s information with the information from the image file IN Move Exam Step 2 of Copy Patent Information Replace This With This Top Desk Rand Janica Bom 05 06 1355 Bom 05 23 1373 65 01 150 bs Erim 125 0 be White Female While Female 196552 Dr MeCoy Yes please copy patient info C No leave patient info alone 6 Select Finish 5 10 Copy exam file Use the Send Exam File feature to copy an image file from the database to another location 1 Select the image you want to copy 2 From the Directory menu select Send Exam File To and select Disk 3 A Compress Files prompt will appear The default is to compress files before copying to disk This allows more files to be included on a single disk The user may also configure the software to span multiple dis
17. DPX NT DPX MD DPX Bravo DPX Duo Prodigy Prodigy Advance Prodigy Primo and Lunar iDXA x ray bone densitometers systems using enCORE with Windows xP Professional computers GE Healthcare recommends viewing the instructions for navigating the Lunar enCORE based X ray Bone Densitometer User Manual before proceeding through the online guide for the first time Before operating scanner read the Safety and Technical Specifications manual which is part of operator s instructions Table of Contents PTOI NC LU DE 7 Jee e AE 7 DVC el len E 7 Installation and Operation BEE 11 1 0 Ch OMS and Reie soeeeacg secascindcueeosceiwerteds sec cancame s EEEE D 14 USR ee 14 Wee Main SEEN EE 15 Te ANY ZC E 16 E Malle CIE 18 1 5 New Measurement Screen cccccccccsaseseeeeceeeeceeeeeeeeeeeeeeseaeeeeeeeeeessaaaseess 20 1 6 Quality Assurance screen 23 Tel OOD ei E 24 2 0 Quality ASS UN ln CS E 34 3 0 Measurement EE 37 3 1 Measurement Overview amp Warnings c ccccccccceeeeeseeseeeeeeeeeeeseeeeeeeeeesaaas 37 3 2 Measurement Procedures cccccccccsssseceecceeeceeeceeeseceeseeeeeeeseaageeeesssaaees 38 3o Pediatrics QTM EE 53 JA NS CAIN EE 53 3 9 ONES VISION FCALUIS sraao ERTA Eaa i 55 3 6 Orthopedic Hip Ren Le 56 COM TEE 58 3 8 Spine Phantom Procedure ssaisivssnonnssennneanin anaa na a 58 4 0 Analysis PROCS CS rs cceacscrse se nets crtedctduinsannincecasieentvndeaundedacassindebade skndedeteeanaadestdeacnaned 60 4
18. Imaging from the Analyze toolbar to adjust the image 3 If necessary select Points from the Analyze toolbar to adjust point typing DO NOT adjust the point typing unless the program made obvious errors If you adjust point typing select Results to view the analysis results based on your changes Bone Points Neutral Points Tissue Points of 4 Typically no adjustments are necessary to ROI placement DO NOT adjust move rotate or size the Neck ROI unless it is obviously incorrect The Neck ROI should be positioned as follows The Neck ROI includes no part of the greater trochanter The Neck ROI includes soft tissue on either side of the neck The Neck ROI is perpendicular to the femoral neck The Neck ROI contains little or no ischium If the ischium is included in the Neck ROI the program automatically assigns the bone within the ischium as Neutral Page 68 of 138 5 GE Healthcare LUNAR does not recommend adjusting the Neck ROI AA Select the Search tool to position the neck ROI correctly Search locates the region of the lowest BMD and most narrow area of the neck If it is necessary to perform further adjustments select the ROI tool from the Analysis toolbar to complete the procedures that follow e Move Select the Move ROI tool Use the cursor to select and move the Neck ROI and the Neck Axis e Rotate Select the Rotate ROI tool Use the cursor to select and rotate the Neck ROI and the Neck Axis e
19. ROIs or Points Select Cancel i Esc to delete changes you made to the image file EH Results This option is shown after you select ROIs or Points Select Enter Results to view analysis results for the image file Report Select to create analysis reports for the image file Ctrl Shif t P en Ctrl S Close Select to close the image file isl Esc 1 4 Directory Screen The Directory screen is shown when you select Directory from the Main screen or from the Common toolbar This screen lists the patient files and images that are stored in the active database The Directory Screen is divided into four areas 1 Search Option 2 Patient List 3 Image List 4 Database Sidebar Page 18 of 138 Tap Paces aS r H Eie Mosam rahm Grocory QA Took Window Hee zW P H w e kK Hk ces ager ee liad Le ee Live IR ET Pacios Weirgfsh Frps foes Pa Ack 4 GE Patient La oa eke be ar chet tr t it eats At Hds be Liber Fanan 1 4 1 Search Use the Search option to quickly locate a patient record and image file in a large database The Search option is located near the top of the Directory screen 1 Select the database field to use in the search 1 2 Enter the patient information to use in the search 2 3 Select Search The patient record and associated image files are shown in the Patient and Image lists The All Patients button clears the search criteria and lists all the patients in the database 1 4 2
20. X X NA Total Body NA X X X NA Lateral LVA NA X X X NA Spine BMD Orthopedic Hip NA X X X NA Hand NA X X X NA Page 129 of 138 1 The Manual Import Wizard will prompt for the selection of an existing patient or select New Patient if the patient is not in the current database 2 Select the Manufacturer and scan type from the drop down lists e Enter the date of the imported scan Enter Patient Height and Weight Enter the manufacturer Select the scan type Select the calibration used 3 Conversion factors are not displayed when entering the import values for the analysis regions Enter the scan BMD values into the blank field The converted value is displayed as you enter a value Image Source Hologic Image Site AF Spine Calibration Hologic BMD Hologic BMD BHD Ge g cn ien L1 L4 L L4 4 Select Finish The import will be labeled in the directory as a Manual Import 5 8 3 Image Support The corresponding image files may be added to the database for viewing e DPX IQ AP Spine DualFemur Femur Forearm Total Body and Ortho e EXPERT AP Spine DualFemur Femur Forearm Total Body Ortho and Hand When an image has been added the directory will provide the original File Name Measurement Date Measured Date Analyzed 5 8 4 Importing Entire Databases lt is recommended that a new database be created prior to importing an entire database and that the reference data has been enabled under Tools User Options
21. a hard drive location for the working path Page 19 of 138 and a removable media drive for the archive drive This information is always available on the Directory screen All Databases are presented on the database sidebar Creating more than one database is especially useful for customers performing research studies The database currently active is highlighted in the available databases list To change databases highlight the desired database from the list The lower portion of the Database sidebar shows all available databases and database maintenance options If you do not see this information select More gt gt Database Maintenance tools provide the ability to edit create rebuild or compress the database Refer to Edit Database Compress Database or Rebuild Database New Database for additional information 1 4 4 Directory toolbar The Directory toolbar displays options that let you work with your patient files Icon Tool Description _ _ Edit Select to edit Primary Secondary and Additional data for the Patient highlighted patient record in the Patient list The edits are not Ctrl E saved to image files that have already been acquired for the patient Use the Edit Image tool to edit information for individual image files New Enter a new patient that is not in the patient database Ctrl N Delete Select to delete the highlighted patient exam or image file You Del ican delete the patient exam or im
22. appropriate scan mode based on the thickness of the femur area Note that the scan mode for the femur may be different than the scan mode used for the AP Sine based on the patient s weight distribution Use the graphic shown to adjust the position of the laser light Position the laser light approximately 7 8 cm below the greater trochanter where the transverse Pubic Symphysis and midline of the femur intersect If you are performing a DualFemur measurement position the laser light for the left femur first Monitor the image to make sure it is correct The Femur image shows the greater trochanter 1 femoral neck 2 and ischium 3 A minimum of three centimeters of tissue should be shown above the greater trochanter and below the ischium Select Abort and reposition the laser light if the image is not correct DualFemur DualFemur lets you measure the patient s left and right femur in an automatic sequence After the program has measured the left femur the scan arm moves to the approximate start position for the right femur Check the start position and if necessary adjust the measurement start position for the right femur Note DPX Duo and DPX Bravo have a narrow scan region Therefore repositioning the patient for the contra lateral femur may be necessary Page 42 of 138 5 Select Close to exit the New Measurement screen Refer to the topic New Measurement screen for additional screen functions 3 2 5 Forea
23. excluded from the scan analysis in some cases The scanner can be used to monitor changes in bone mineral over time in patients with these disorders but caution must be taken in interpretation Use DXA estimates as an aid to other methods in the evaluation of patient bone mineral status in the clinical setting In addition spine estimates will be difficult to interpret for patients with orthopedic metal devices and previous surgical interventions such as bone grafts Radiographic contrast material and radiopharmaceuticals used for myelograms barium enemas and other diagnostic tests prevent accurate estimates Barium clears the body within a few days but the oil based dyes used in myelograms several years ago may remain within the body for years A three day waiting period is sufficient time for barium and most radiopharmaceuticals to be completely discharged from the body Femur estimates will be difficult to interpret for patients with orthopedic metal devices and previous surgical interventions The most common complicating factors for femur estimates are prosthetic devices and surgical implants in the region of the bone scan Results may be adversely affected if the patient has difficulty with the desired 25 inward rotation of the leg or with maintaining this position without movement Total Body estimates require consistent patient positioning for accurate results and will be difficult to interpret for patients with orthopedic metal devices and previ
24. glass of beer 285 ml a single measure of spirits 30 ml a medium sized glass of wine 120 ml or 1 measure of an aperitif 60 ml Has a history of hip fracture in the patient s mother or father Is exposed to oral glucocorticoids or has been exposed to oral glucocorticoids for more than 3 months at a dose of prednisolone of 5 mg daily or more or equivalent doses of other glucocorticoids Has a previous fracture in adult life occurring spontaneously or a fracture arising from trauma which in a healthy individual would not have resulted in a fracture Has a disorder strongly associated with osteoporosis These include type I insulin dependent diabetes osteogenesis imperfecta in adults untreated long standing hyperthyroidism hypogonadism or premature menopause lt 45 years chronic malnutrition or malabsorption and chronic liver disease Has a confirmed diagnosis of rheumatoid arthritis Currently smokes tobacco 2 Click the boxes next to the NOF ISCD Filters to place a check mark in the appropriate filters See the following guidelines to determine if the filter should be selected for a patient On Treatment Examples of On Treatment patients include Page 123 of 138 e Estrogen Hormone Therapy or SERM within the past one year e Calcitonin within the past one year e Parathyroid Hormone PTH within the past one year e Denosumab within the past one year e Bisphosphonate within the past two years unless it is
25. head ROI on DXA reports select Tools User Options Reports tab Click on the Report Regions button Click on the Total Body tab Page 98 of 138 Highlight the desired region or TBLH Total Body Less Head option in the left Available window TBLH indicates the head is omitted from the analysis Click on the Add button The new selected region ROI will be added to the Selected list on the right Repeat the same steps to add the ROI region to the Composition Report Densitometry Ref TBLH BMD BMD g cm4 AM Z score RW O Skeletal Age 8 0 5 6 7 amp 9 10 11 12 13 14 15 16 17 18 19 20 Age years Densitometry Note the variable SD reference values for pediatrics are shown with tapered edges since children mature at different rates Page 99 of 138 4 15 2 Pediatric AP Spine and Femur Analysis Pediatric AP Spine and Femur will provide reference data for U S and European reference populations 4 15 3 Pediatric Monitoring Tools Pediatric Growth tools can be found under the Peds tab in the analysis screen The software will provide information on Bone Size and Lean Body Mass Assessment Fetare Information meaag Age 6 0 Tacinque wed Tanner Whilehouse Pubertal Stage incl pected Techriqu uted Tanner Sages Bone Size Assessment Value 50 0 i 2D Al 40 Dt Bd H a0 WI 1 Height fer Age Cente Valys 5 t jA ee ee Kl ig 20 a 40 Cl Bal ZU 30 w T DC dee Bane Area Werte 10
26. made The software will return to the main Practice Management Tools dialog with the report recently edited highlighted Select Next to advance to Available Report Types Page 107 of 138 BMD Site Region Filters Click the BMD Site Region Filters button to choose the Sites and Regions for the T and Z score reports Click the box next to the sites and regions to select Click the plus symbol to expand the sites to display the available regions Site Region Select Pa E Lak As Lan Click the Copy from Physician Reports button to use the Sites and Regions from Composer Ab i 1 i L ese T c e Deleting Queries Select Delete from the Practice Management dialog to permanently remove a business report Once the user highlights the report to be deleted and selects Delete the software will display a dialog to confirm deletion of the report Select OK to permanently delete the Business Report History Catalog Click the History Catalog button to view the History Chart Note In order to view a History Chart multiple Pie Charts must be saved under one Condition or query heading 4 19 3 Available Reports Use or modify one of the sample report queries or create a new report query Select the Output format Patient List HCFA Form Mail Merge or Chart 1 Patient List generates a list of all patients meeting your query criteria Click the Customize button to tailor the patient list output Selec
27. minimum number of patients a warning will appear If the selection meets the minimal requirements a progress bar will appear Pee breeds tt Sri pink hih kawei rs Tee i ced EI r nl M pami nied tints Page 119 of 138 Step 3 The Results tab will be displayed Each numbered tab represents a data set Units If 2 scans of 30 patients were done only two gg Sei SE numbered tabs will appear giem pp ett e o L C giem 0 034 LSC o 29 Step 4 At the bottom of the window are the output options buttons Export allows saving results as a ixt file Report will open your default printer window Select Apply to apply the adjustment to the current database Results BMD Average BMD SD Standard Deviation This is the Precision Error in g cm CV Coefficient of Variation SD Mean in percent LSC Least Significant Change at 95 Confidence Interval Least Significant Change LSC at 95 Confidence Interval Precision Error x 2 77 lf Apply is selected the footnote indicating your precision will be found in the printed DXA report The first example indicates 68 of the repeat scans for this lab fall within 1Standard Deviation plus or minus 0 010 g cm2 for this site and region 1 Statistically 68 of repeat scans fall within 15D 0 010 g cm for AP Spine L1 L4 4 23 Custom Analysis Create custom ROls for image files Custom Analysis results are given in BMD BMC Area only reference
28. patient i considered osbeoperic according to World Health Organization WHO criteria Bone density i between LO and 25 below young mormal Fracture rsk is moderate Treatment is sel Oo Recommendation HOF Guidelines recommend treatment for patients with a T score of 1 5 and below with risk Factors or 2 0 and below without risk Factors Effective therapies are available in the form of bisphosphonates Fosamax and Actonel and Evista Hormone therapy may be an option based on T People with diagnosed cases of osteoporosis or at high risk For Fracture should have regular bone 2 mineral ER testi id pag ty aca og E routine ER is alowed once every 2 gt rapidly SC E Year s from measured date ep To select an assessment for editing select fr from list above left click with mouse on chart assessment area 7 Change Breaks The Breaks tab in the Assessment Editor window lets you change the assessment cutoffs by adding or removing the lines that define the boxes 1 Select Assessment Editor from the Composer menu 2 Select the Breaks tab 3 Add or remove break lines To add a break line select the location of the new break from the drop down lists on the left side of the window and then select Set Remove To remove a break line use the drop down lists to select the location of the line you want to remove and then select Set Remove NOTE You can also add and remove break lines directly
29. shaft and implant are perpendicular to the scan path 3 scan continues 2 3 cm above the greater trochanter i K 3 7 Quick View QuickView offers a fast 10 second Spine or Femur scan that may be useful for quick review of a region This option provides a BMD and T Score value for females and males who are gt 20 years of age Measurement and Analysis procedures are the same as other scan mode procedures Standard scan modes provide optimal precision and are recommended for follow up scans to monitor changes in BMD Determine precision with the scan mode used to monitor patients The larger pixel width of QuickView results in reduced resolution For more details on the scan mode specifications review the Safety and Specification help file 3 8 Spine Phantom Procedure While many instruments require a separate Quality Control to be run in addition to the Quality Assurance the enCORE based scanner does not require this separate measurement The daily QA procedure run on the scanner both calibrates the machine and also has bone chambers that are used for Quality Control measurements This removes the necessity of requiring a phantom to be measured by the user for separate control measures The phantom is considered a service tool Every system includes an aluminum spine phantom and water container An encapsulated phantom is available for purchase Page 58 of 138 Water Container Encapsulated A Spine Phantom baseline was p
30. stop button to routinely abort a scan Software Installation If loading software you will be asked for your system number and feature code during the installation procedure These numbers are printed on the CD sleeve Put the CD in the CD ROM drive When the Installation window appears select the product software option Follow the screen prompts to install the program The software will attempt to install validated Microsoft Security updates on all U S computers before installing the product software This may take up to 45 minutes The Help disk Second disk contains Help Topic documents in PDF format for printing You will need Adobe Acrobat Reader to open PDF documents Note If the CD does not automatically start select the My Computer icon on the desktop select the CD ROM drive and select the software installation icon Page 6 of 138 Introduction Intended Use The X ray Bone Densitometer DPX Bravo DPX Duo DPX NT Prodigy iDXA supports the following intended use Provides an estimate of bone mineral density at various anatomical sites Spine Femur Total Body and Forearm These values can then be compared to an Adult reference population at the sole discretion of the physician Provides an assessment of relative fracture risk based on the patient s T score value using the categories of fracture risk defined by the World Health Organization WHO Provides an assessment of 10 year fracture risk using WHO FRAX model Pro
31. the graph with the different WHO or JSBMR classifications Normal Osteopenia and Osteoporosis 4 21 5 Reference results Use of the reference population comparisons is fully at the discretion of the clinician The program does NOT show the comparative values when shipped from GE Healthcare LUNAR 1 Reference graph Select Densitometry from the Results tabs to examine the reference graph The Reference graph show the patient s T Score and Z Score results 2 Reference results table The results table shown below the Reference BMD BMC Area Region f i giem car graph gives the results for each region analyzed wu aad va ue e e To view the results for a region on the Reference G HE a Cen graph highlight the region Bi 1297 200 wem WI 1235 3061 2478 W Lia 12523 OS LO mi 273 en WG 1 287 5352 4207 Mie i oss 231i BMD values should be considered together with other risk factors low body weight fracture history corticosteroid use use of long acting tranquilizers history of falling in the patient evaluation In particular patients with a prior history of osteoporotic fracture should be considered to have double the risk of future fracture at any density level 4 21 6 Patient Trending enCORE provides a monitoring tool to view changes in a patient s BMD over time To view trending results 1 all of the trended measurements must be from the same site and 2 each trended measurement must be analyzed
32. this box means backup is allowed on this workstation Every workstation should have its own backup Backup Drive Change the drive location that is used to backup the software configuration and database files Days Between Backup Prompt Change the number of days between display prompts to backup the patient database The database maintenance tools are not displayed by default Select the More gt gt button if you are unable to view the database maintenance tools Page 126 of 138 5 5 New Database Select New Database from Database sidebar to create a new database of patient records and database files Select the More gt gt button if you are unable to view the database maintenance tools The New Database dialog box gives the options that follow Name Record a name for the new database to be used to store patient records Microsoft Access 2000 2003 or 2007 OR Microsoft SQL Server 2000 or 2005 interface Location Designate a drive destination and a name for the new directory for the new database the default is the hard drive Archive Drive Designate the drive to be used to archive files for the database Description Record a description of the new database if necessary Allow Archive from this workstation only available with the multiple user option Change the archive and restore permission for this workstation A check mark in this box means archive and restore are allowed on this workstation This setting is i
33. your changes Page 90 of 138 4 10 5 Trending Morphometry 1 Options to trend Morphometry on screen are found under Tools User Options Trending Change Trend On option under Tools User Options Trending or on the Morphometry Trend tab in the analysis screen Select A P Ratio Anterior Height Average Height M P Ratio Middle Height P A Ratio or Posterior Height 2 Systems ji ZE Trend Graph Options Morphometry Heights Morphometry Trend Compare Information Trend T11 Avg Ht Change vs Baseline 2 Analyze 2 EA Trend Table Options E Results Display 1 AF Trending Precision Calculator TS vi e iT j Reference Data Ee Trend On 3 Image Densitometry Pediatric 7 Score g An Densitometry Adult wa Reports Compose lo Weasure Trend Graph Options Line Pattern Densitometry Graph C Percent Change vs Ce Reference when available TI Axis Automatic Scaling W X Axis Automatic Scaling Morphometry Graph e Percent Change vs Absolute Value Composition Graph Percent Change vs Composition Trend Display 32 096 32 098 32 100 32 102 32 104 Age years Region T11 l rend On Average Height Middle Height Posterior Height Cancel 3 Trend Table Options are found under Tools User Options Trending Trend Table Options Page 91 of 138 Trend Table Options Avail
34. 20 EI ao cp EI 70 a0 CA 100 Bone area for Haight ariile Lean Mass Assessmert 0 10 20 AU el EI ZU ap cd UO LBhifor Height Cente Value 30 0 mm 2 4 4 45 7 8 100 BHC far LEM UC ecite Reporting the Growth Information The Pediatric information must be entered in the Patient Information screen Bone Size Assessment e Height for Age Centile e BMC for Bone Area Centile e Bone Area for Height Centile Lean Mass Assessment e LBM lean body mass for Height Centile e BMC for LBM Centile In the Reports options select the Ancillary check box to report the Growth Analysis data Page 100 of 138 4 16 Small Animal Body Analysis 4 16 1 Small Animal Body Analysis Procedure Both the bone and soft tissue images are shown when you open a small animal body image for analysis Changes you make to the cut positions on one image are also made on the other image You can turn off the dual image option in the User Options image tab Refer to the topic Options for further information on configuring User Options Complete the steps below in the order given to complete a Small Animal Body analysis 1 Select an image file for analysis 2 Select Imaging and adjust the image if necessary 3 Make sure the small animal cuts are positioned as follows 1 Head The Head cut is located immediately below the chin 2 Left and right arm Both arm cuts pass through the arm sockets and are as close to the body as possible
35. 5 Park Scanner Select Park Scanner Ctrl K from the Measure menu to move the scan arm on a mobile system to the foot of the table for lockdown Page 22 of 138 1 6 Quality Assurance screen pJ l D The Quality Assurance screen is used to complete a Quality Assurance QA procedure This screen is shown when you select Quality Assurance from the Main screen or from the Common toolbar 1 6 1 Quality Assurance Toolbar Jon Toot Deserietion _ Trend QA trending history is automatically shown after a QA procedure LIT F2 unless you have changed this behavior in the User Options If the trending history is not shown you can select Trend to view the QA trending history after you complete the QA procedure a setting Select to change information for trending F3 S Report Select to create a report of the QA results tae Ctri P Abort Select to stop the QA test e a gt Start Select to start the QA procedure Q Enter Close Select to exit the QA screen K Esc 1 6 1 System Status The Quality Assurance screen indicates the current operating status of the system The System Status should indicate System is ready to measure patients before performing patient measurements to ensure accurate results Refer to the topic Quality Assurance for instructions on performing a quality assurance procedure Page 23 of 138 1 7 Options Select Options from the Main screen or select the Tools menu
36. AHA tab under the Hip Axis Length Comparison chart This DualFemur measurement example indicates a comparison mean of 108 7 mm The patient s right hip axis length is 100 2 mm and the left hip axis length measured 100 2 mm iia AXIS SE SE mm A 20 10 T ean 10 Al EN Hip Axis Length Comparison Mean 108 7 mm Right 100 2 mm Lett 100 2 mm Page 70 of 138 4 6 4 Upper Neck and Lower Neck Regions Upper Neck ROI indicated in red on this Lower Neck ROI indicated in red on this image includes the bone above the neck axis image includes the bone below the neck line This region is automatically determined axis line This region is automatically by the software based upon the Neck ROI determined by the software based upon position and the calculated neck axis position the Neck ROI position and the calculated neck axis position Upper Neck Reference Data Reference Upper Heck Comparison to Reference Data is BMD g er YA T Seore available for the upper neck region ll bk Femur upper neck reference data ia Da available for both males and females for the following reference populations USA Germany Australia UK Brazil and 070 Finland Both Young Adult and Age Matched Results are displayed for Upper Neck Age matched adjustments are 046 3 provided for weight and ethnicity for all supported populations The Upper Neck region can be found immediately below 0 22 i age the Neck in the region table SE Age pear
37. Default QA Copies Automatic Daily QA Print Automatic return to trend screen Graphical Interface Enable QA stability analysis Compress Patient Database after QA Allow QA Block scans outside of Daily QA Select the trend regions desired for each scan type User Information will be used as a header for all DXA reports Morphometry Trend Regions Deformities Only or All Regions Morphometry Trend Results Average Height Posterior Height Middle Height Anterior Height P A Ratio M P Ratio and A P Ratio Choices JPG PNG or WMF JPG PNG or WMF JPG PNG or WMF Automatic or manual configuration of Quality Automatic or manual configuration of Resolution General options Spelling Suggestions Dictionary or Customized Dictionary Advanced Settings and Performance amp Accuracy settings Add password protection to PDF documents exported Set permissions for printing and editing ICD9 Codes On or Off Choices Enter number of copies On or Off On or Off On or Off On or Off On or Off On or Off Page 31 of 138 QA Means Reset Means Activation QA AutoMentor Enable AutoMentor to automatically export QA report to email or Fax if QA fails 13 Measure Tab Function Choices Save Prompt at the end of a scan On or Off Allow a continue option after SmartScan abort On or Off Show Previous Scan On or Off Allow Scanner Start Button to initiate a On or Off Measurement Use Old Positioner for Lat
38. Does not use the foam leg block positioner Help the patient onto the scanner table and position the patient as follows in the center of the scan table Use the centerline on the table as a reference to align the patient The patient s arms should be crossed over the chest away from the side of each hip E Select Position from the New Measurementtoolbar The scanner arm moves to the approximate start_position A graphic is shown that gives the correct patient position and measurement start position OneScan Does not use the foam leg block positioner Use the centerline on the scanner table as a reference to make sure the foot brace is centered Align the centerline with the guide on the base of the foot brace Internally rotate the patient s legs and secure the patient s feet to the foot brace GE Lunar suggests not removing the shoes Page 40 of 138 3 Laser Position Use the graphic shown to adjust the position of the laser light Position the laser light approximately 5 cm below the patient s navel and in the same longitudinal plane as the patient s midline 4 Ne Select Start from the New Measurement toolbar to start the measurement Monitor the image to make sure it is correct 5 Make sure the spine is in the center of the image all of L4 1 is shown the top of L5 2 is shown in the first 1 2 sweeps for Prodigy 5 15 scan lines for DPX 3 Approximately 1 2 of T12 is shown If the image is not correct select A
39. GE Healthcare Lunar enCORE based X ray Bone Densitometer User Manual Revision 5 Part number LU43616EN Jan 2010 GE Medical Systems LUNAR Contact Numbers Headquarters GE Medical Systems Lunar 3030 Ohmeda Dr GE Medical Systems IT GmbH Madison WI 53718 Munzinger Strasse 3 5 USA D 79111 Freiburg Germany 1 800 437 1171 49 212 2802 652 49 0761 45 43 233 fax China France No 19 Changjiang Road 11 Avenue Morane Saulnier Wuxi Jiangsu 214028 78 457 VELIZY P R C 33 1 34 49 5365 86 510 85225888 33 1 34 49 5406 fax 86 510 85226688 fax www gehealthcare com CE cir DPX Series YZB USA 2099 DPX Bravo SFDA Register Number SFDA I 20023301115 Product Standard Number Prodigy Series YZB USA 0509 Production License Number SFDAII 20043301375 Production amp Registration Address iIDXA YZB USA 1104 2007 SFDA I 20073302084 Service Address Postal Code Contact Phone Germany Beethoven Str 239 D 42655 Solingen Germany 49 212 2802 0 49 212 2802 390 fax Asia Pacific 4 7 127 Asahigaoka Hino shi Tokyo 191 8503 Japan 81 42 585 5111 81 42 585 3077 fax JSFDA I 2009 No 2300674 YZB 7 0637 2009 IRA Un CE PVF 2001 00415 No 19 Changjiang Road Wuxi National Hi Tech Development Zone Jiangsu P R China GE Medical Systems Trade Development Corporation Shanghai Co Ltd 3 floor CTP1 building No1 Huatuo Road ZhangjiangGaoke Shanghai 201203 8008108188 Operator s Manual for
40. Lengthen ROI Select the Size tool Use the cursor to include tissue on either side of the neck if none is present Never edit the Neck ROI width 2 Select Results to view the analysis results 7 Select Save to save your changes Refer to Basic Analysis Procedure for additional Femur Analysis information 4 6 Advanced Hip Analysis The values computed by this software option are used to estimate the structural properties of the hip The values are not for clinical diagnosis of a disease 4 6 1 Advanced Hip Analysis Options Advanced Hip Assessment Results are available for Femur and DualFemur reports Advanced Hip Assessment Results AHA includes upper neck region lower neck region hip axis length HAL and hip strength results AHA is a purchased software feature Page 69 of 138 Go to Tools User Options Analyze tab to enable these options 4 6 2 Advanced Hip Assessment Advanced Hip Assessment AHA includes all the standard femoral regions of interest previously available In addition AHA provides a measurement of two new regions of interest upper and lower femoral neck automated determination of hip axis length and hip strength values Lower Femoral Neck Trochanter Ward s Shaft Total Hip defined as the density of the combined region of the femoral neck trochanter and shaft regions 6 Upper Femoral Neck 7 Hip axis length HAL CO PS oh 4 6 3 Hip Axis Length HAL can be found on the
41. Lunar suggests not removing shoes Page 54 of 138 3 4 3 OneScan Measurement During a combined AP Spine and DualFemur or single femur measurement the software immediately proceeds to the femur setup With the OneScan feature enabled the software proceeds directly to the positioning screen indicated below for adjustment of the laser light position The OneScan feature eliminates this pause as the patient is already positioned with their feet in the DualFemur brace for femur measuremenis Deg Hotaled neead Shent Slapped Securely A Gente Brace on Pad G Lager Light mid Pegh o mat below puter apmphyais A Pause may be enabled between scans This option is found in Tools User Options Measure tab Check the desired options 3 5 OneVision Feature The OneVision feature allows the user to set up multiple measurements within one exam This eliminates keystrokes and improves throughput for customers that routinely perform multiple measurements on each patient OneVision feature is required for DICOM or HL7 reporting interfaces By default the enCORE software includes the exam combinations of AP Spine DualFemur or AP Spine DualFemur LVA Exam combinations can be found at the top of the Exam list The images included in the Exam are displayed in tab view above the skeletal image When scanning with a series of OneVision scan types select Next to proceed to the next image site in the exam or Repeat t
42. Microsoft Access For File name enter the path and filename of the Access Database you can find this by selecting the Access database in enCORE and looking at the Database line under Active Database Alternatively copy the Access lunar mdb file to the server first then select the copied file The transfer will be faster if the file is already on the server d Select Next 2 Select Destination of Microsoft OLE DB Provider for SQL Server Enter the Authentication method of your choice for example select Use SQL Server Authentication and enter Username and Password for a user with Admin rights to SQL Server 3 Select your new database as Database a Select Next b Select Copy tables and views from the source database c Select Next d Check every table in the list except Version which should stay unchecked e Select Next twice then Finish Page 136 of 138 5 16 Task Scheduler 5 16 1 Task Scheduler Tools Select Tools Task Scheduler The Task Scheduler window appears Use the tools to Add Edit or Delete a task and then click OK Icon Tool Description d Add Click the Add button to add a new task P Edit Click to highlight the task to edit and then click the Edit button It This button is only available when a task is available in the list Click to highlight the task to delete and then click the Delete x Delete button This button is only available when a task is available in t
43. OVIDED FOR IN THIS LICENSE i DECOMPILE DISASSEMBLE OR REVERSE ENGINEER THE SOFTWARE except to the extent applicable laws specifically prohibit such restriction ii COPY MODIFY ADAPT TRANSFER TRANSLATE RENT LEASE GRANT A SECURITY INTEREST IN OR LOAN THE SOFTWARE OR ANY PORTION THEREOF iii CREATE DERIVATIVE WORKS BASED UPON THE SOFTWARE OR ANY PORTION THEREOF OR iv REMOVE ANY COPYRIGHT OR PROPRIETARY NOTICES OR LABELS IN OR ON THE SOFTWARE b You understand that GE Medical Systems Lunar may update or revise the Software and in so doing incur no obligation to furnish such updates to You under this License GE Medical Systems Lunar has no obligation to improve update or support the Software in the future c In the event the instrument or product designated for the Software is sold or otherwise transferred to a third party that party is not authorized to use the Software unless they first pay to GE Medical Systems Lunar the applicable license fee and agree to the terms and conditions of a Software License Agreement Upon transfer of the Software or any copy thereof the License granted hereunder shall terminate immediately 3 TERM AND TERMINATION This License is effective until terminated This License will terminate immediately without notice from GE Medical Systems Lunar or judicial resolution if You fail to comply with any provision of the License Upon any termination of this License You agree to return or destroy the Software
44. Patient and Image lists Use the Patient and Image lists to select a patient to measure or an image file to analyze Double click on a highlighted patient record to start a new measurement or double click on a highlighted image file to analyze the image file e Patient list The Patient list shows patient records in the database according to the patient s last name first name and ID The patient information for the selected patient is also shown in the Patient block at the bottom of the Directory New Measurement and Analyze screens e Image list The Image list shows the measurement images recorded for a patient according to measurement type date measured date analyzed file name and label The image list may include exams made up of multiple measurement images Assign a status or notes to an exam by right clicking on the exam in the directory and selecting Change Status or Notes Choose from a list of 5 status types Icon Status No Icon Not Reviewed Pending Review GA Rejected wi Approved 8 Closed Enable Exam Status notes features and set defaults actions when sending a report and status colors under Tools User Options Directory Directory Status 1 4 3 Database Sidebar The Database sidebar shows the database that is currently being used active database and the working path of that directory The Active Database panel indicates the location of the database and the drive used for archiving patient studies Most systems will use
45. ROI RB Add ROI Click on Add ROI tool and then select desired ROI from menu Select ROI to relabel then click Label ROI tool Choose desired label from menu ee non e a activate Click Angle tool to change angle configurations Onscreen control to show or hide ROIs 4 4 2 APVA Spine Geometry Analysis Procedure The software will automatically place the ROIs in most cases The vertebrae used for analysis are defined as the last vertebral bodies at extreme ends of the spinal curvature where the end plates tilt to the side of curvature concavity Use the APVA Spine Geometry Analysis tools to adjust ROIs In patients with multiple spinal curves each component can be measured To add additional ROIs 1 Click the Add ROI button or press the Insert key on keyboard The Add ROI menu should appear 2 Select the superior end vertebra from the menu and move the ROI line through and parallel to the superior end plate on the superior end vertebra using the Spine Geometry analysis tools if necessary 3 Click the Add ROI toolbar button or the Insert key on the keyboard again The Add ROI menu should appear again 4 Select the inferior end vertebra and move the ROI line through and parallel to the inferior end plate on the inferior end vertebra using the Spine Geometry analysis tools if necessary The Cobb Angle degrees will show to the right of the scan image under the Geometry tab in the Geometry table Geometry Information Geom
46. VIDED IF FAILURE OF THE SOFTWARE HAS RESULTED FROM ACCIDENT OR ABUSE GE MEDICAL Page 4 of 138 SYSTEMS LUNAR SHALL HAVE NO RESPONSIBILITY TO REPLACE THE SOFTWARE GE Medical Systems Lunar will consider this warranty to be void if You fail to comply with the terms in the Software License Agreement 6 TITLE Title ownership rights and intellectual property rights in the Software shall remain with GE Medical Systems Lunar This Software is protected by the copyright laws and treaties 7 MISCELLANEOUS This Agreement represents the complete agreement concerning this License and may be amended only by a writing executed by both parties The License is governed by the laws of the State of Wisconsin U S A without regard to its conflict of laws principles If any provision of this Agreement is held by a court of competent jurisdiction to be unenforceable that provision shall be enforced to the maximum extent permissible and or reformed only to the extent necessary to make it enforceable and the remaining provisions of this Agreement will not be affected or impaired in any way If any legal action or proceeding is brought for the enforcement of this Agreement or because of any alleged dispute breach default or misrepresentation in connection with any of the provisions of this Agreement the successful or prevailing party shall be entitled to recover reasonable attorneys fees and other costs incurred in such action or proceeding in addition to any o
47. Working Path that you wrote down above Name Data 2 Working Path D data SG C Microsoft Access e Microsoft SOL Server settings Click on Settings Select SQL Server In the SQL Server Settings dialog e Enter Server Name of the server on which SQL Server resides e Enter anew Database Name of your choice e Enter User ID and Password of an ID with creation rights such as an Administrative account Change permissions to a more restrictive account later if desired Page 135 of 138 SOL Server Settings Database is Local to this computer server Name NYu UBS Database Name BMD 0 C Use Windows authentication e Use SOL Server authentication Login Name GE Lunar Password w Remember Login Info iM Perform Exclusive Lock and Backup when upgrading recommended Backup Folder w Use Database Folder recommended When creating a new database the account specified by User ID needs to have creation rights such as an Administrative account After the database is created you can change this to a more restrictive account if desired The account must always have atleast read write rights to this database Reset Working Folder Cancel Select OK on all the dialogs 6 At the SQL Server 2000 1 Import the Data into your SQLServer a Using SQL Server Enterprise Manager right click on the new database select All Tasks Import Data b Select Next c Select Data Source Type of
48. able Data Columns Selected Data Columns Change vs Baseline Geht Change vs Baseline Change vs Baseline difference fyr Change vs Baseline difference Change vs Previous Bis gg Remove Change vs Previous yr Change vs Previous difference Change vs Previous difference yr Eed Gen WM Flag significant change 4 Options to trend Morphometry on DXA reports are found under Tools User Options Reports Morphometry Report Options Multiple trending selections can be made for a single report Morphometry Report Options Morphometry Trend Regions fe Deformities Only recommended All Regions Morphometry Trend Results Iw Average Height M Posterior Height I Middle Height JW Anterior Height Pla Ratio IT M P Ratio AJP Ratio 5 Composer Trending options are configured within the Composer program Refer to Basic Analysis Procedures for additional Analysis information Page 92 of 138 4 11 LVA Spine Geometry Analysis LVA Spine Geometry features only appear in the enCORE software if you purchased the LVA Spine Geometry option for your bone densitometer 4 11 1 LVA Spine Geometry Analysis Tools Spine Geometry Description Analysis Tool Rotate ROI Click on the Rotate ROI tool Click and drag near the end of the ROI Ld Move Size ROI Click on the Move Size ROI tool Click and drag ROI or edges as needed DN Delete ROI Click on the Delete tool and then click the target ROI A
49. age record s or the record s and related exam or image file s Move Select to move exam to another patient record F4 Archive Select to copy or move exam files from the computer hard F5 drive to an archive location You can archive single exams single patients or all patients You can also archive all exams for all patients found during a search Close Select to exit the Directory screen Esc 1 4 5 Help Text Help Text is located in the lower left corner of every screen in enCORE software The Help Text provides keystroke functionality current operation of the system and instructions for the software user 1 5 New Measurement Screen The New Measurement screen is used to complete a new measurement for an existing patient recorded in the database or for a new patient This screen is shown or when you select Measure from the Common toolbar Page 20 of 138 A list of applicable measurement sites is presented on the New Measurement screen The user may select the measurement site from the Exam List or highlight the measurement region on the corresponding Skeletal Image 1 5 1 Analyze When Done option Select the Analyze When Done option if you want to analyze the image file after the measurement the Analyze screen is shown immediately after the measurement is complete 1 5 2 Patient and laser position graphic a When you select Position from the New Measurement toolbar a graphic is shown ay which illus
50. all accompanying written materials and all copies thereof in any form Section 5 will survive any termination 4 EXPORT LAW You agree that neither the Software nor any direct product thereof is being or will be shipped transferred or re exported directly or indirectly into any country prohibited under United States law or regulations promulgated thereunder 5 WARRANTY GE Medical Systems Lunar warrants that to the best of our knowledge the software provided with this License will perform as described in the product s operator s manual and the technical specification for this Software This limited warranty is contingent upon proper use of the Software and does not cover any Software which has been modified subjected to malicious logic unusual physical or electrical stress or used on computer equipment not specified by GE Medical Systems Lunar GE Medical Systems Lunar does not warrant that the functions contained in this Software will meet your requirements or that the operation of the Software will be uninterrupted or error free Statements made about this Software do not constitute warranties and shall not be relied upon by You in deciding whether to purchase the GE Medical Systems Lunar product or use the Software IN NO EVENT SHALL GE HEALTHCARE BE LIABLE TO YOU FOR ANY DAMAGES ARISING OUT OF THE USE OR INABILITY TO USE SUCH SOFTWARE THE SOLE AND EXCLUSIVE REMEDY IN THE EVENT OF DEFECT IS EXPRESSLY LIMITED TO THE REPLACEMENT OF THE SOFTWARE PRO
51. ally create Reference ROIs when needed Jee Automatically create ROIs for T8 L4 when opening exam Finish Button Finish Button On Off A Options Operation to perform Send Report s to destinations Save Exam and Close Exam e Estimated Total Estimate Body Fat from Spine Femur scan On or Off Body 5 Results Display Tab Icon Function Choices Reference Graph Young Adult YA Bars Standard SD WHO or JSBMR Options Show Y2 axis values Age Matched AM Bars appearance and SD applied Densitometry Table Young Adult YA in or T Score Age Matched AM in or Options T Score Show BMC Show Area Show Diagnostic Category Icons and Show All DualFemur Regions Composition Options Z Score or Centile Results Metric or English measurement system Morphometry Reference in Z Score or Percent Height Reduction Reference Options Configuration for assigning deformity Mild Moderate and Severe BMI Options BMI cut off points assigned per WHO or Custom BMI On or Off Page 27 of 138 6 Trending Tab Icon Function Choices Trend Graph Options Select Line Pattern Densitometry Trend Graph Morphometry Trend Graph or Composition Trend Graph settings to be displayed Precision Calculator A complete Precision Tool to determine Least Significant Change LSC for scan types AP Spine Femur DualFemur Total Body Forearm Hand and Lateral Spine Choice of Measures For Densitometry Pediatric Densitometry Adult to Trend On Morphometry Compos
52. an oral taken for lt 2 months Note Calcium and vitamin D do NOT constitute On Treatment in this context Previous Fracture Hip or Spine Prior hip or vertebral fracture clinical or morphometric 3 DualFemur measuremenis will automatically select the region Left or Right with the lowest femoral Neck BMD lowest Change this selection by clicking on the region of choice Left Right or Mean 4 Select the appropriate FRAX Population from the dropdown menu If the patient s country is not represented select the country for which the epidemiology of osteoporosis most closely approximates the patient s country Based on the FRAX model Sweden and US are considered very high risk UK and ltaly are considered high risk China Spain France and Japan are considered moderate risk Turkey is considered low risk 5 Click the Calculate button The 10 year probability of hip fracture and 10 year probability of a major osteoporotic fracture will be displayed 4 24 3 FRAX 10 Year Fracture Risk Reports The following FRAX 10 Year Fracture Risk reports are available Composer FRAX DXA reports DualFemur FRAX Left Femur FRAX and Right Femur FRAX availability based on open exam Refer to DXA Results Report and Composer Report sections for more information on generating reports FRAX is a trademark of the University of Sheffield Medical School Centre for Metabolic Bone Diseases A World Health Organization WHO Collaborating Cen
53. ance reasons these files are left temporarily in the database Compress Database also performs a repair function on the database The software will display a message once database compression repair is completed Compression of the Patient database successful When it is necessary to compress the database a message is shown when you exit the program Compress the database to improve performance Select Yes to compress the database Note Large databases may take a long time to compress Always initiate the Compress utility from the closest proximity to where the database resides in networked environments Note The database maintenance tools are not displayed by default Select the More gt gt button if you are unable to view the database maintenance tools Page 125 of 138 5 3 Delete Database The Delete Database option is located in the Directory menu 1 Select the database you want to delete in the Database sidebar 2 Select Database Utilities from the Directory menu 3 Select Delete Entire Database A warning message appears verifying that you do want to delete the database Click OK to continue or Cancel to abort the deletion process When you select OK the Delete Database dialog box gives the options that follow Just remove database connection removes the database name from the database list but does not delete the database file from the database folder Select this option if you want to remove the database from the pr
54. and or Apply US NOF ISCD FRAX recommendations Review the NOF ISCD FRAX Implementation Guide from the link in the enCORE software for details Choices Sort by First name Last name or Patient ID Ascending or Descending Sort by Measurement Date Measured Date Analyzed File Name Archive Import or Status Ascending or Descending Choose Patient Third column contents Patient ID Facility ID Department ID or Exam ID When duplicate patients occur follow Duplicate Patient Match Rule Select Default Gender Default Ethnicity Duplicate Patient Match Rule Use Patient Last Name amp Birthdate or Use Patient ID Checkbox Option to Expand Exams view in the directory by Default Enable Exam Status notes features Also set defaults actions when sending a report and status colors Page 26 of 138 4 Analyze Tab Icon Function Choices to Appear in the Results Wl Femur Analysis AHA Hip Axis Length Upper Neck region Lower Neck region Options Calculate Hip Strength results and Hip Geometry results Total Body Calculate Left and Right results LI Analysis Calculate Total Body Less Head TBLH result used for Pediatric EE Options P Forearm Forearm Calibration Lunar SPA or Comac Analysis Options Orthopedic Standard Gruen zones or Extended Gruen zones si Analysis Options Small Calibration Chemical Ash or Lunar LI Animal Research Options Morphometry Create ROIs on Request Recommended e Options Automatic
55. art is based on Last Name Reading Physician Lowest BMD T Score City Attendant Site of Lowest BMD T Score State Insurance Company Region of Lowest BMD T Score Postal Code Indications Lowest BMD Z Score Country Treatments Site of Lowest BMD Z Score Gender Fractures Region of Lowest BMD Z Score Referring Physician Clicking once on a particular cut will pull the cut from the Pie graph and display the details of that cut To examine all the details of the chart double click anywhere on the pie chart A complete list of the components and statistics appear Select Save This To History The History Chart is used to track saved Pie chart trends over time In order to create a History Chart multiple Pie Charts must be saved under one Condition or query heading Click on the Browse button to save the chart to a location of your choice Page 109 of 138 SE Lunar Corporation 726 Heartland Trail Madison WWI 53717 1915 Patents over 69 years scanned more than 22 months aga Lowest T Score History Chart i Greater than A E _Belween ond l o _Batween 3 and 3 Belween 4 ad 3 cb Less than E L E SS wh wh wh Select either the Printer or File option to output te information 4 20 Composer Reports Composer is a purchased feature to create patient summary reports for referring physicians The assessments that are appropriate for the patient s results are included in the summary report Note For detailed infor
56. ative for assistance The USB drive must be formatted as NTFS The USB drive must never be unplugged while the computer is running or without disabling the remote drive first within the operating system Windows XP will automatically detect and assign a drive letter when the external drive is plugged in You may control the drive assignment by going to the Control Panel switch to XP Classic View Click on Administrative Tools Computer Management Click on Storage Disk Management Right Click on the Removable Drive and select Change drive letter and paths Click on the Change button Enter the drive letter that must always be used for archiving and click OK In enCORE go to the Directory screen Select Edit Database Enter the applied drive letter in the Archive Drive and Backup fields Refer to the chapter on Archive for additional information 5 15 SQL Database Interface 5 15 1 SQL Interface Prepare for SQL Interface 1 Update to enCORE software version 10 0 or later 2 SQL Customer Requirements e Customer must have SQLServer 2000 or 2005 installed on an available server No special installation is necessary on the client s Page 134 of 138 e The version of SQLServer must be 2000 or 2005 this is not optional because we are using features of SQLServer that are not available in SQL s earlier releases e The site should be familiar with how to install and configure SQLServer Lunar does not support this e They als
57. bel and positioning and make appropriate changes if necessary Make sure each vertex of the ROI is centered in the vertebral endplate Re do the auto endplate finding by double clicking in the exact center of the vertebra c Click on Next d Click on L4 in the Morphometry Wizard window and click on Next e Verify the heights of L2 L3 and L4 and make changes as needed These vertebrae will be used as a reference If any of the reference vertebrae are deformed it will not be used in the stature adjustment Click on Finish f To analyze additional vertebrae repeat steps a b and click on Finish ll Automatically create Reference ROIs when needed a Click on a vertebra that appears deformed as close to the center of the vertebra as possible b The Morphometry Wizard window will open Verify the ROI label and positioning and make appropriate changes if necessary Make sure each vertex of the ROI is centered in the vertebral endplate Re do the auto endplate finding by double clicking in the exact center of the vertebra c Click on Finish L2 L3 and L4 ROls will automatically be created d Verify the heights of L2 L3 and L4 If changes are necessary click on the vertebra to open the Morphometry Wizard and make appropriate changes e To analyze additional vertebrae repeat steps a b and click on Finish lll Automatically create ROIs for T8 L4 when opening exam Page 89 of 138 a T8 L4 ROls will automatically be created upon opening scan
58. bort reposition the laser light and restart the measurement SE 6 If you want to complete another measurement for the patient select Set Up from the New Measurement toolbar Refer to the topic New Measurement screen for additional screen functions 7 If you have completed measurements for the patient select Home to move the scanner arm to the Home position 8 al Select Close to exit the New Measurement screen Refer to the topic New Measurement screen for additional screen functions 3 2 4 Femur DualFemur measurement 1 Help the patient onto the scanner table and position the patient as follows The patient s body is in the center of the scanner table use the centerline on the table as a reference to align the patient The patient s arms are crossed over the chest away from the side of each hip Page 41 of 138 2 el Na Select Start from the New Measurement toolbar Ht Select Position from the New Measurement toolbar The scanner arm moves to the approximate start_position A graphic is shown that gives the correct patient position and measurement start position for the site you are measuring Use the centerline on the scanner table as a reference to make sure the foot brace is centered Align the centerline with the guide on the base of the foot brace Internally rotate the patient s legs and secure the patient s feet to the foot brace GE Lunar suggests not removing the shoes Select the
59. ck on the Adjust Vertices tool Click and drag vertices as needed Be Position This tool is only available on LVA scans after reference f Reference ROIs vertebrae are identified This will reposition the reference ROIs abel Label ROI Click on drop down menu and select correct vertebra to label ROI ROI Suggestions e Select the Move Size ROI tool or the Rotate ROI tool to move or rotate an ROI e Select the Delete ROI tool to delete an ROI e Right click an ROI and choose Relabel or click an ROI to enter the Morphometry Wizard and use the Label ROI tool to re label an individual ROI e Select Save to save changes or select Close then No if you do not want to save changes 4 10 2 LVA Morphometry Configuration The Morphometry analysis feature is available if you purchased the LVA option for your bone densitometer The enCORE software will provide the Morphometry results for the vertebrae of interest according to the parameters setup in Tools User Options Results Display Morphometry Reference Options A Z Score Morphometry Mode uses Average Height A P and M P ratios in the results and includes stature adjustment B Percent Reduction Morphometry Mode uses the ratio of posterior height to anterior height to check for Compression Therefore when Percent Reduction mode is used P A ratios are provided Checking stature adjustment while in Percentage Adjustment mode provides the additional output of Average height val
60. correct patient and laser position for the scan type 6 Position the laser cross hair in the on the letter R in the word LUNAR on the L5 vertebral body of the phantom Start the scan Page 59 of 138 T12 L1 L2 L3 L4 L5 Once approximately half of T12 is imaged select Abort from the toolbar Choose Save measurement from the Save Dialog Box and select OK if the measurement was performed correctly For spine phantom analysis it is necessary with to verify and adjust accordingly for the following vertebral heights L2 3 00 cm 02 cm L3 3 50 cm 02 cm L4 4 00 cm 02 cm L2 L4 region height should be 10 5 cm In the Analysis screen select ROI s tool to view this information 4 0 Analysis Procedures 4 1 Basic Analysis Procedures 4 2 AP Spine Analysis 4 3 APVA Morphometry Analysis 4 4 APVA Spine Geometry Analysis Page 60 of 138 4 5 Femur Analysis 4 6 Advanced Hip Assessment 4 7 Total Body Analysis 4 8 Composition Analysis 4 9 Lateral Spine Analysis 4 10 LVA Morphometry Analysis 4 11 LVA Spine Geometry Analysis 4 12 Forearm Analysis 4 13 Hand Analysis 4 14 Orthopedic Analysis 4 15 Pediatric Analysis 4 16 Small Animal Analysis 4 17 Custom Reference Population 4 18 ScanCheck 4 19 Practice Management Tools 4 20 Composer Reports 4 21 DXA Results Report 4 22 Precision Calculator 4 23 Custom Analysis 4 24 FRAX 10 year fracture risk
61. ct to move the ROI edges Do not move the lines unless BS they are obviously incorrect Select to move the vertices of the ROI of 4 If necessary select Points from the Analyze toolbar to adjust point typing Do not adjust the point typing unless the program made obvious errors If you adjust point typing select Results to view the new analysis results based on your changes Bone Points Neutral Points Tissue Points 5 Select Save to save your changes or select Close then No if you do not want to save your changes Refer to Custom Analysis Procedures for additional Analysis information Page 96 of 138 4 14 Orthopedic Analysis 4 14 1 Basic Analysis Tools for Orthopedic Orthopedic Analysis is done automatically Select either Standard Gruen or Extended Gruen Zones Set the default Gruen method in Tools User Options Analyze and select the Ortho Analysis Option Toggle between Standard and Extended Gruen zones from the ROIs screen E Verify that the ROIs and implant length are correctly identified The following tools are available on the ROIs screen LH Click on the ROIs Tool to view the following options Icon og Desoription lt lt Y te Gruen Gruen zone ae Length Edit the Length of the Implant The Ruler icon allows the user to measure the implant length The Ruler provides a measurement value real time by clicking on the edge and moving to the user s choice of destination Either edge
62. d Settings Select the Archive Style The options are e Incremental option will only archive files that have changed since the last Archive operation e Complete option will re archive all files whether or not they were previously archived e Check the Delete local file s after Archiving to delete all images from the original database location after Moving the images to the archive location e Click on the Set as Default Advanced Settings bar to keep the archiving preferences you have chosen 5 7 Rebuild Database 5 7 1 Rebuild Database Note Import first then rebuild Select Rebuild Database from Database sidebar to recreate rebuild a database that has been lost due to a computer hardware malfunction In addition you can use this option to include additional files in your database You can rebuild the database from files that you have copied into your working directory system default or from files stored on an archive disk Select the More gt gt button if you are unable to view the database maintenance tools 1 Select Rebuild Database The Rebuild Database dialog box displays 2 To rebuild the database from an archive disk select Archive Directory as your Source Option Otherwise leave the Source Option set to the Working Directory default 3 Select how you want the image files filtered in the Filter By dialog box 4 Select the files you want to use to rebuild the database or select Select All to use all of the f
63. dd ROI Click on Add ROI tool and then select desired ROI from menu Label ROI Select ROI to relabel then click Label ROI tool Choose desired label from menu After at least two ROIs have been added the Angle tool will activate Click Angle tool to change angle configurations Show Hide ROIs Onscreen control to show or hide ROIs 4 11 2 LVA Spine Geometry Analysis Steps The software will automatically place the ROIs in most cases The vertebrae used for analysis are defined as the last vertebral bodies at extreme ends of the spinal curvature where the end plates tilt to the side of curvature concavity Use the LVA Spine Geometry Analysis tools to adjust ROIs To add additional ROIs 1 Click the Add ROI button or press the Insert key on keyboard The Add ROI menu should appear 2 Select a vertebra and move the ROI line through the superior end plate of the chosen vertebra using the Spine Geometry analysis tools if necessary 3 Click the ROI toolbar button or the Insert key on the keyboard again The Add ROI menu appears again 4 Select another vertebra Another ROI line is placed on the LVA scan Move the ROI through the inferior end plate of the chosen vertebra using the Spine Geometry analysis tools if necessary The Cobb Angle degrees will show to the right of the scan image under the Geometry tab in the Geometry table Geometry Information Endplates Geometry Cobb Angle degrees 5 Three reports are ava
64. de If the user clicks on the blue hyperlink Patient thickness the following dialog is displayed with both a description of the problem detected and a recommended solution ScanCheck Assessor Example Description U The wrong scan mode may have been selected for this patient s thickness Recommendation Consider rescanning the patient using the proper scan mode based on patient thickness Hyperlinks are available for all ScanCheck indications with the yellow exclamation point 4 18 3 ScanCheck Check Rerun The software will automatically rerun ScanCheck checks once the user goes into ROIs The user can make modifications based upon ScanCheck recommendations in the ROI screen and select Results Note ALWAYS manually review and consider any ScanCheck findings Page 104 of 138 4 18 4 Adjusting ScanCheck Thresholds scanCheck features can be disabled or adjusted in Tools User Options ScanCheck tab Some aspects of the detection can be adjusted to be relatively more or less sensitive Decreasing the detection threshold will make the ScanCheck detection more sensitive Increasing the threshold will make the detection less sensitive The Default button returns the threshold to its original value 4 18 5 Adjustable Thresholds ScanCheck Heading threshold degrees 0 90 Scan was started too low Scan Start Threshold mm 5 0 200 0 Scan was stopped too late Scan End Threshold mm 5
65. device to the sale distribution and use by or on the order of a physician Operator Profile The intended users of the DXA scanner are medical professionals with knowledge and experience required to work with x ray equipment Training Information GE Medical Systems Lunar or authorized GE Medical Systems Lunar distributors provide individual hands on training as part of the installation procedure for your system GE Medical Systems Lunar distributors provide training for systems installed outside the United States An Applications Specialist provides information on software and hardware operations and reviews the warnings and cautions in the manuals IMPORTANT Only trained technologists should operate the system New technologists should receive training prior to unsupervised operation of the system Additional training sessions are available on request for a nominal fee For more information contact GE Medical Systems Lunar Support at 800 334 5831 or your local GE Medical Systems representative Cautions for DXA Determinations You should be aware of the following factors which may affect the clinical accuracy of DXA spine estimates marked distortions of skeletal architecture e g osteophytes degenerative disc disease spinal arthritis soondylolisthesis kyphoscoliosis and vertebral fractures and significant calcium deposits in the aorta can falsely elevate spine bone mineral values Regions that contain these dystrophic calcifications can be
66. dition to the above fixed ranges the spine and femur thickness values should fall within limits which vary with BMI which are given in the equations below BMI is calculated from the height amp weight entered Asian Female spine thickness cm 7 861 0 06798 BMI 5 54 Asian Female femur thickness cm 0 07868 2 669 V BMI 3 39 Asian Male spine thickness cm 8 958 5 313V BMI 6 63 Asian Male femur thickness cm 2 633 3 277 V BMI 4 10 Page 82 of 138 4 8 7 Half Body Scan to Estimate Composition For very wide patients that do not fit within the scan boundaries it is recommended that the analysis of half of the body be done In this example only the entire right half of the body fit into the scan area Click on the 5 tool then click on the tool to estimate one side of the body from the other If the Total Body is derived from an estimate from half of the body an e will appear next to the Region column in Densitometry and Composition results tables and next to the Measured Date column in Trend tables Densitometry Composition Trend Total ican BHD BMC Area YA AM Total Mass l g cm ig cm T Score S core 1172672007 fe Legs 1 693 1 611 952 i mag le Trunk 1 245 1 412 1134 i e Ribs 1 214 559 461 fe Pelvis 1 236 54 439 a Spine 1 375 311 235 S im Page 83 of 138 4 8 8 iDXA Composition Color Mapping iDXA enCORE software provides the option to color map th
67. e height of the Android ROI Lateral boundaries are the outer Leg cuts The A G ratio is between the Fat of the Android central and Fat of the Gynoid hip and thigh regions The Enhanced Composition report page will display the Android Gynoid ratio 4 8 2 Composition BMI Body Mass Index BMI reference graph is from the World Health Organization s classification BMI has been added to the Composition display tab if the composition results option is selected The graph is intended for adult men and nonpregnant women that are 20 years of age or older The BMI is a simple but objective anthropometric indicator of the nutritional status of the adult population The 4 configurable reference graph divisions are Underweight lt 18 5 BMI Normal 18 5 24 9 BMI Overweight 25 0 29 9 BMI Obese 30 0 and above BMI Weight in kilograms Height in meters Body Composition BMI Graph is available in Composer Reports as an option Note BMI does not distinguish between fat and lean Therefore BMI is not a good indicator of ideal body weight for athletes and body builders with above average lean muscle mass In other words an athlete with a large muscle mass may have a BMI in the overweight range but not be overweight for his her body size 4 8 3 Composition Trending Options The options to change trending graphs is found on the Composition Trend tab in the Analysis Screen Page 76 of 138 Densitometry Trend Composition Co
68. e measurement region 7 5 amp Select Position from the New Measurement toolbar The scanner arm moves to the approximate E CC ei SAM measurements be careful that the scanner arm does not bump the patient s head 6 Use the graphic shown on the New Measurement screen to adjust the position of the laser light The Laser Light is positioned in the center of the wrist adjacent to the ulna styloid If necessary move the positioner and the patient s arm so that the laser light shines in the center of the patient s arm and is aligned with the blue line on the forearm positioner Make sure the patient s eloow makes a 90 degree angle and make sure the forearm positioner is straight on the table top All of the ulna styloid should be visible The forearm bones should be centered and straight Page 44 of 138 7 Ne Select Start from the New Measurement toolbar to start the measurement Monitor the image to make sure it is correct Make sure the forearm is in the center of the image and the distal end of the ulna 1 is shown near the top of the image If the image is not correct select Abort reposition the laser light and restart the measurement i A 8 EI Select Close to exit the New Measurement screen Refer to the topic New Measurement screen for additional screen functions 3 2 6 Lateral Spine LVA measurement Option 1 Put the lateral positioner on the table Positioner A should unfold and set over the back rail of the table P
69. e total body scan 1 Click on the Color 4 2 Click on the Color Mapping Thresholds button AA to make threshold Mapping button to adjustments the left of images in the Analysis screen to display Color Mapping Thresholds Low Threshald High Threshold Cancel 3 Default Tissue mapping colors are red orange and yellow where red represents an area of low level Fat orange represents an area of medium level Fat and yellow represents an area of high level Fat These colors are customized under Tools User Options Image Image Colors Tissue Color Mapping CT High Level Change Default Ee Medium Level Change Default Low Level Change Default 4 8 9 Resting Metabolic Rate RMR and Relative Skeletal Muscle Index RSM Resting Metabolic Rate RMR and Relative Skeletal Muscle Index RSMI are Composer field codes RMR which is synonymous with Resting Energy Expenditure REE is an estimate of how many calories are burned at a resting state and represents the minimum amount of energy needed to maintain body temperature heartbeat and respiratory rate RMR is calculated using Harris Benedict equations 1 RMR male 66 473 6 775 age yrs 13 7516 weight kg 5 0033 height cm Page 84 of 138 RMR female 655 0955 4 6756 age yrs 9 5634 weight kg 1 8496 height cm RSMI represents the relative amount of muscle in the arms and legs and is calcu
70. eature lets you invert the gray scale for images on your faxes An analog phone line is required The Fax option is only available if you purchased the TeleDensitometry kit Email Use this option to change the default settings for the email feature In Outlook Express or Outlook setup a Personal Address Book to interface with enCORE The Add case information to Subject feature automatically includes the patient s name the scan type and the name of the file you are emailing in the Subject line of the email message Make sure a check appears in the check box if you want to use this feature The Invert Image feature allows you to invert the gray scale for images in your emails The Image quality drop down list allows you to choose the quality level for images included in your emails Quality affects the size of the image The Email option is only available if you purchased the TeleDensitometry kit DICOM Use this option to change the default settings for the DICOM feature If you change the store folder location you will also have to change the Report Folder Location setting in the LUNAR DICOM program The DICOM Worklist feature displays a list of patients who are scheduled for DXA measurements The list is supplied by the hospital information system Make sure a check appears in the Directory in Worklist Mode check box if you want to use this feature The DICOM option is only available if you purchased the DICOM kit HL7 Use this
71. ecific GE Medical Systems Lunar product The Software is provided under the terms of this Agreement and is licensed to You not sold Your rights to use the Software are subject to the terms and conditions contained within this License Agreement and GE Medical Systems Lunar reserves any rights not expressly granted to You This License is non exclusive and a non transferable license to use the GE Medical Systems Lunar Software Re distribution of Software or any documentation provided to you by GE Medical Systems Lunar is strictly prohibited This product includes some software components that are licensed under the GNU General Public License GPL Source code for GPL components is available upon request The terms and conditions of this License Agreement and Limited Software Warranty are as follows 1 LICENSE This License allows You to a use the Software on a product in accordance with the accompanying documentation To use the Software means that the Software is either loaded in the temporary memory of a computer or installed on any permanent memory or media of a computer eg hard disk CD ROM optical disk zip disk and the like b make one 1 copy in machine readable form of the Software as provided to You solely for the purposes of backup provided that such copy includes the reproduction of any copyright notice or other proprietary notice appearing in or on such Software 2 LICENSE RESTRICTIONS a YOU MAY NOT EXCEPT AS EXPRESSLY PR
72. elow the More bar Assign the database a new name Review the Database Chapter for more information 2 No imported scans should be included in your precision study database 3 All scans must be analyzed using identical regions If any patient in the study does not match the whole criteria it is excluded from the precision calculation 4 You must have completed the study criteria to utilize this tool e Use two scans per patient 30 patient minimum e Use three scans per patient 15 patients minimum 5 If there are additional scans included for the patient the calculator will only use the most recent Page 118 of 138 4 22 2 Precision Wizard Precision lap Spine ll Regon o o o L lz Jas 0 030 0 030 0 030 0 030 0 030 x Default Confidence Interval Ce 95 f a0 Step 1 Check one option e Use two scans per patient 30 patient minimum e Use three scans per patient 15 patients minimum Select the scan Sites and select the Regions to be evaluated A Precision Wizard tool is available to assist the technologist step through the process of generating the results from the completed Precision Calculation study without additional spreadsheet tools Select Tools User Options Trending Precision Calculator Click on the Wizard button 95 Confidence Interval is recommended Hold the Ctrl key down while highlighting all the study subjects Select Next If the selection does not meet the
73. en aged 20 29 years The physician should review local clinical guidelines then determine the optimal FRAX configuration 4 24 1 Enable FRAX Select Tools User Options System tab and press the FRAX button enCORE software provides options to configure FRAX to always calculate a patient s fracture risk Check Enable FRAX or calculate FRAX according to NOF ISCD recommendations Both checked as shown below or never calculate FRAX Both unchecked The default is both unchecked Click OK The FRAX tool has been developed by WHO to evaluate fracture risk of patients Please configure ERAN and press OK Iw Enable FRAX M Apply U S NOFASCD FRAX Recommendations This software has been optimized to comply with the NOF TSCD FRAX Recommendations For more information review the NOF TSCD ERAN Implementation Guide NOF ISCD ERAN Implementation Guide NOTE These recommendations apply only to the U S FRA is a trademark of the University of Sheffield Medical School s Centre for Metabolic Bone Disease a World Health Organization WHO Collaborating Centre The NOF and ISCD recommend DXA software calculate FRAX output only when the patient meets NOF criteria for using FRAX to assist with treatment decision i e a An untreated postmenopausal woman or a man age 50 or older b With low bone mass T score between 1 0 and 2 5 c With no prior hip or vertebral fracture clinical or morphometric d And an evaluable hip for DXA study
74. eral Measurements On or Off Densitometry and Morphometry only LVA Reverse scan arm direction Patient head On or Off at foot of the table Default to seated patient for forearm and hand On or Off scans Pause between Femur scans On or Off OneScan Foam Leg Block positioner not used On or Off for AP Spine scans Pause between AP Spine and Femur scans On or Off Adjust the speed of movement of the scan arm Transverse Joystick Speed amp Faster or Slower Longitudinal Joystick Speed Download scanner firmware service tool Initiate download 1 7 2 Connectivity Options Connectivity options let you change report delivery fax email DICOM and HL7 default settings 1 View Connectivity Options Select Bi F6 from the Main screen and select Connectivity Options OR Select the Tools menu and select Connectivity Options 2 Select one of the Connectivity Options tabs that follow Connectivity Description Options Report Delivery Use this option to select the recipient of your e mailed and faxed results reports 3 Referring physician The program sends reports to the physician listed in the patient s Primary information Page 32 of 138 pe Reading physician The program sends all reports to the physician listed in this field Use this option to change the default settings for the fax feature The Receive Incoming Faxes feature lets you receive faxes if you have a fax modem attached to your system The Invert Image f
75. erformed with the installation of your scanner This will be found within the patient database For general use use the same patient information that was established with that Spine Phantom scan NOTE The procedure below assumes you are familiar with AP Spine scan and Analysis procedures 3 8 1 Measure the Spine Phantom Put 15 cm of water in the plastic container and position the aluminum phantom in the middle of the plastic container Position the phantom so that L5 is toward the foot of the scanner 1 From the Main Menu screen select F2 Measure 2 Have you measured the phantom before e lf yes select the phantom from the patient list and continue to step 5 e fno continue to step 3 to record the information for the spine phantom 3 Record the primary information in the dialog box e First name Spine Middle initial None Last Name Phantom Birth Date Record the current date minus 40 years For example if today s date is September 28 2006 type 09 28 1964 DO NOT change this date for future Spine Phantom measurements e Height 67 inches e Weight 154 pounds or 70 kilograms e Sex Male e Ethnic Group White 4 Select the secondary tab and record the following information Facility ID Record the phantom number given on the L5 region of the spine phantom Department ID Record your System ID number This number is located in the User Options System tab 5 Select Position from tool bar A graphic is shown which illustrates
76. ession line Weight Adjustment and Ethnic Adjustment 2 Body Weight Body weight is moderately associated with BMD r 0 3 As weight increases or decreases bone density generally increases or decreases proportionally For every kilogram of weight above or below the average weight for men 78 kg and women 65 kg the expected BMD is adjusted by 0 004 for AP Spine BMD and 0 003 for femur BMD This weight adjustment is applied for weights between 25 and 100 kg Weight adjustments are applied to Age matched values Z Score only Young Adult T Score values are not affected If the same patient weighs 90 kg instead of 45 kg the blue regression bar shifts upward while the patient s BMD is unchanged In other words the Age matched weight adjustment increased the patient s expected BMD 3 Ethnic Adjustment The Ethnic Adjustment like the Weight Adjustment only affects the Age matched regression bar Young Adult values are not affected The ethnic adjustment takes ethnic origin into consideration for the final Age matched comparison The program automatically shifts the Age matched regression bar up or Page 116 of 138 down according to ethnic origin if this option is turned on or off in Tools User Options Reference Data 4 enCORE may be configured to display the World Health Organization WHO or Japanese Society for Bone and Mineral Research JSBMR Bars in Tools User Options Results Display Tab Reference Graph Options This option labels
77. etry Endplates Cobb Angle degrees ECH 5 Three reports are available for APVA Spine Geometry Reporting APVA Spine displays the APVA scan image and any Cobb Angle analysis Geometry Dual VA Spine displays the LVA and APVA scan images only This report is only Geometry available if the exam contains both LVA and APVA scans Standard Dual VA Spine displays the Cobb Angle analysis without images This report is only Geometry available if the exam contains both LVA and APVA scans Ancillary Refer to Basic Analysis Procedures for additional Analysis information Page 67 of 138 4 5 Femur DualFemur Analysis Note The results tabs for Femur images include a ScanCheck tab with a list of Yes No questions These questions should be used to assist in the analysis of the image and to help you make corrections where necessary The answers to the questions can be recorded on the tab The tab also includes space for comments To print the checklist select Print ScanCheck 4 5 1 Femur Analysis Procedure 1 Select an image file for analysis Note When you open a DualFemur image for analysis the left and right femur images are both shown The active femur has a blue box around its image window Click inside an image window to make that femur image the active image The results include BMD values for each region of each femur and averages and differences between femurs Reference data and trending are available 2 If necessary select
78. ew Measurement toolbar to start the measurement Monitor the image to make sure it is correct Make sure the image is correct e The image starts in the Sacrum so that all of L5 is visible e Atleast 2 5 cm of soft tissue is shown on the anterior side of the vertebrae e The image ends in L1 for a Lateral Spine measurement near T4 for an LVA Morphometry measurement or near C1 for a LVA Spine Geometry Measurement Page 47 of 138 e All ofthe posterior elements appear in the image e The edge of the positioner may appear in the image This is not a problem If the image is not correct select Abort reposition the laser light and restart the measurement 9 If you have completed measurements for the patient select Home to move the scanner arm to the Home position 10 LN Select Close to exit the New Measurement screen Refer to the topic New Measurement screen for additional screen functions 3 2 7 APVA Measurement Option 1 Follow the same scan procedure that is typically for AP Spine measurements Ht 2 E Select Position from the New Measurement toolbar The scanner arm moves to the approximate start position APVA Morphometry scan length can be increased to 55 4 cm APVA Spine Geometry scan length should be increased to 69 5 cm 3 Use the graphic shown on the New Measurement screen to adjust the position of the laser light Position the laser light approximately 5 cm below the patient s navel End the scan in T4
79. exit the program from the Main screen Page 15 of 138 Measure F2 select to start a patient measurement Directory F4 select to work with your patient files and complete database maintenance procedures Options F6 select to change the User Options and Connectivity Options default settings or to view the Error log 1 2 1 Common Toolbar ij The Common Toolbar is shown on all screens Icon Program Description S O Measure Select to enter patient information or select a patient from F2 or Ctrl M the database to start a new measurement aS Analyze Select to choose an image file for analysis F3 or Ctrl A F4 or Ctrl D maintenance procedures Select to start a Quality Assurance QA test F5 or Ctrl Q 1 3 Analyze Screen The Analyze screen is used to analyze image files This screen is shown when you select Analyze from the Common toolbar or the main screen or when you select an image file for analysis from the Directory screen In addition this screen is shown immediately after a patient measurement if the Analyze When Done option is selected at the New Measurement screen 1 3 1 Results Tabs The data that follows is included in the Results tabs for image files ScanCheck tab provides a checklist of items to confirm and or correct during analysis Densitometry tab provides BMD BMC and Area for each region of the scan Trend tab provides results trending over time Informatio
80. for APVA Morphometry Measurement or near mandible for APVA Spine Geometry Measurement APVA Morphometry Measurement Center and Square Patient End at T4 c m D DN _ Laser Light iz cm below navel D ee d A Start in L5 Page 48 of 138 APVA Spine Geometry Measurement Center and Square Patient End at Mandible yy Wy m Laser Light 5 cm below navel E NQ Laser Light 5 cm below navel f TU ee Startin L5 4 Ne Select Start from the New Measurement toolbar to start the measurement Monitor the image to make sure it is correct 5 Make sure the image is correct If the image is not correct select Abort reposition the laser light and restart the measurement 6 If you have completed measurements for the patient select Home to move the scanner arm to the Home position or select next 7 E Select Close to exit the New Measurement screen Refer to the topic New Measurementscreen for additional screen functions 3 2 8 Dual VA Measurement Option Dual VA measurement includes both APVA and LVA measurements in one exam 3 2 9 Total Body Measurement Option 1 Make sure all attenuating materials belts metal buttons etc are removed from the measurement region For Total Body scans all materials that may cause significant attenuation must be removed Help the patient onto the scanner table and position the patient as follows A the pat
81. for analysis b Verify ROI label and positioning If changes are necessary click on the vertebra to open the Morphometry Wizard and make appropriate changes c To analyze additional vertebrae click on a vertebra as close to the center as possible The Morphometry Wizard window will open Verify the ROI label and positioning and make appropriate changes if necessary Make sure each vertex of the ROI is centered in the vertebral endplate Re do the auto endplate finding by double clicking in the exact center of the vertebra Click on Finish 2 The software automatically assigns the Morphometry label for all analysis types Ave Ht Avg Ht PZA Ratio M P Ratio A P Ratio nepon ee GI GI E GI EE gll Li 2 05 D 101 103 55 L 2 04 J6 100 5g 100 L3 KH Je a 91 103 ee L4 245 12 BS CE 118 Label Mild Wedge Moderate Wedge Severe Wedge Mild Biconcavity Moderate Biconcavity 3 To change a Morphometry deformity label click on the Change Deformity icon D and then click on the vertebra of interest A warning will appear click OK A list of deformities will be displayed Select the desired deformity indication label When you assign a deformation to a vertebra the symbol for the deformation appears next to the ROI label in the results table in the Analysis window Note Only use this tool to override automated morphometry analysis 4 Select Save to save your changes or select Close then No if you do not want to save
82. from the Tools menu 2 Select New in the Create Reference Data dialog box 3 Enter a name for the new custom reference population Then select Edit 4 Enter detailed information on the new custom reference population When you have finished select OK Bit Custom Densitometry Keference Data bi Population Custom Test Populaton verson 8 Titi AF Spine 7 Regon L i414 F Gender hae sl Aduatment age Menage O We r sD sel Au Set Loweer Limit a eet a Change EC Sat 3 Loweer Leet T Upper Lirit 100 4 17 2 Edit a Custom Reference Population 1 Select Custom Reference Data from the Tools menu 2 Inthe Custom Reference Data dialog box select the population that needs editing from the drop down list Then select Edit If you want to delete the population select Delete instead 3 Edit the existing custom reference data When you have finished select OK Page 103 of 138 4 18 ScanCheck ScanCheck formerly known as CAD or Computer Assisted Densitometry assists the user in detecting Spine Femur Forearm and Total Body abnormalities ScanCheck provides guidelines to minimize operator error through identification of potential measurement and or analysis errors ScanCheck assesses consistency of the current AP Spine or Femur scan to the previous scan When potential anomalies are identified helpful instructions are displayed as well as multimedia help A checklist of measurement and analysis task
83. ft Select OK e ClearView For LVA and iDXA AP Spine Femur and Forearm images you can adjust the sharpness To increase or decrease the sharpness of the image move the arrow up or down the ClearView scale Page 61 of 138 e Zoom To zoom the image use the bar to scroll through the percentage values Select OK Use the W Pan tool if the image is larger than the window area on the Analyze screen Check Show Advanced Features to adjust Threshold Range Black White Controls or Image Type and to reset contrast e Threshold To adjust the threshold select the Threshold option and either move the vertical lines that are shown on the bone profile enter values in the black white fields or adjust the Brightness Contrast controls Select OK e Range To adjust the range select the Range option and either move the vertical lines that are shown on the bone profile or enter values in the black white fields Select OK e Black White Enter a value in the Black and White fields Select OK e Type Click the drop down menu and choose between the following image types Enhanced Bone Tissue and Unfiltered Bone Select OK e Reset Contrast Select Reset Contrast to reset settings Select OK Use the tools given in the following table to magnify an image during analysis These tools are shown on the Analyze screen Tool Description Reset Select to deactivate the Zoom and Pan Image tools K Mode el Zoom Move the cursor over the image and use the Zoom
84. he list 5 16 2 Adding and Editing Tasks A Task window appears after clicking the Add or Edit button Complete the fields as described below and then click OK Field Description Type the task name in the Task field or use the Choose from List button to select from a list of Task common task names Time Use the Time field to set the time for the task to be performed Every Use the Every field to set the task frequency Choose between Day s Week s or Month s Click the When it s time for this task drop down menu to choose the task action Choose When it s time for between Prompt me Perform Archive All or Perform Backup Check the Ask me before this task proceeding box to receive a message containing the Reminder Text before the task begins Edit the Reminder Text as desired 5 17 Batch Exam File Operations 5 17 1 Exam File Export Report Select File Batch Exam File Operations The Export window appears 1 Select between Working or Archive as the Source Directory Change to another database to change the Working Directory 2 Use the Filter By drop down menu to filter the Source Directory 3 Click on the exam s to export report or click Select All to export report all exams in the Source Directory 4 Choose Printer or DICOM from the Destination drop down menu 5 Click OK If Printer is selected for the destination a report will be sent to the default printer based on the default configuration Page 137 of 138
85. he current measurement Refer to Measurement procedure for details on how to obtain an appropriate image measurement Page 55 of 138 3 5 1 Create Exam Protocols The user may create their own exam protocols with the OneVision feature Select Create Exams from the Measure menu on the Windows Tool bar Select the New button to create an exam protocol The user may also delete rename or edit existing exam protocols from the Create Exam dialog Enter a protocol name in the box provided It is recommended to enter a name that describes either the images included in the exam or a specific description of the exam Then select OK Ciena Lanne Once the protocol name is entered you may define the measurement sites included in the exam and the sequence of the measurements in the exam Select the image site from the available sites on the left and select Add to add the image site to the Exam Use the Up or Down buttons to modify the sequence of image measurements in the exam When you have finished click OK 3 6 Orthopedic Hip Option The Orthopedic option lets you get BMD BMC and Area values for patients with femur implants This option is available for research purposes and is only available if you purchased the orthopedic option To perform a patient measurement first select or record the patient as described in Section 3 1 Then select Left Ortho or Right Ortho in the Exam list on the New Measurement screen Informat
86. he patient does not roll forward during the measurement e Adjust the foam wedge between the back of the patient s thighs and the positioner to hold the knees in place during the measurement r 5 Select Position from the New Measurement toolbar The scanner arm moves to the approximate start_position 6 Adjust scan length or width as needed LVA Morphometry scan length can be increased to 55 4 cm LVA Spine Geometry scan length should be increased to 69 5 cm For patients that a unable to rest on their left side for LVA scanning select the Reverse box to allow the patient to rest on their right side and reverse the scan arm direction Use the graphic shown on the New Measurement screen to adjust the position of the laser light Position the laser light at the top of the patient s iliac crest Page 46 of 138 Lateral Spine measurement End in L1 All posterior elements visible 2 5 cm tissue Start in Sacrum so that all of L5 is visible Laser Light LVA Morphometry measurement End near T4 All posterior elements visible 2 5 cm tissue Start at Sacrum so all of L5 is visible Laser Light Note An LVA measurement only produces BMD results when SmartScan is turned off When SmartScan is on the scan time is reduced LVA Spine Geometry measurement End near C1 All posterior elements visible _ 2 5 cm tissue Start in Sacrum so all of L5 is visible Laser Light Ve Select Start from the N
87. he scanner with a waterproof non attenuating material Some plastics and vinyls may have unique x ray attenuation properties that could affect results sch Make sure all attenuating materials metal etc are removed from the measurement region 2 Position the subject on the scanner table Center specimen on center line placing the head toward head end of the table start a few centimeters above the head 25 3 Select Position from the New Measurement toolbar The scanner arm moves to the approximate start position Page 52 of 138 4 Ne Select Start from the New Measurement toolbar to start the measurement of few centimeters above the head 5 Monitor the image to make sure it is correct If the image is not correct select Abort and reposition the subject A 77 If you want to complete another measurement for the subject select Set Up from the New Measurement toolbar 4 7 If you have completed measurements for the subject select Home to move the scanner arm to the Home position 8 LN Select Close to exit the New Measurement screen Refer to the topic New Measurement screen for additional screen functions 3 2 11 Abort measurement V Select Abort F5 from the New Measurement toolbar if the image is not correct or if you determine that a sufficient area of the measurement is obtained When you select Abort the measurement stops automatically when the detector reaches the edge of the scan window A message s
88. hows the options that follow e Resume Measurement Select this option to continue the measurement that you chose to abort e Save Measurement Select this option to save the current measurement e Do not save measurement Reposition this measurement Select this option to start the measurement again using the same settings The box that is shown around the image shows the measurement area Use the arrow keys to move the box and reposition the measurement Select Start from the New Measurement toolbar to restart the measurement e Do not save measurement Set up a new measurement Select this option to change the settings for the measurement 3 3 Pediatrics Option The Pediatric option provides BMC BMD and Z Score values for females and males who are 5 19 years old Measurement procedures are the same as the procedures for adult patients Reference values are available for AP spine Femur and Total body measurements When a patients age Is less than 20 years additional pediatric patient information fields appear automatically Pediatric Skeletal Age and Pubertal Stage This information is obtained by the physician through other means 3 4 OneScan OneScan performs a AP Spine and DualFemur exam without repositioning between scans OneScan does not use the foam leg block positioner for spine positioning 3 4 1 Configuring OneScan On Off Page 53 of 138 The OneScan option can be defaulted on or off through User Options
89. i DEE IS on oe el ellen Talk dep T b ni Eis ELE Fat reg RB Si N b mi Ln bere Fe Keep L Ei i Moimi iml ba PiL rt B e CEG Be Pe Fi PE i im ba sie ike besch L ra A ifa a imp ir HEN rare Dem Par CH Pema Lai Bi sn LN D DT ERT TE ili Legacy QA Report F iii aie QA Ancillary page Page 36 of 138 3 0 Measurement 3 1 Measurement Overview and Warnings 3 2 Measurement Procedures 3 3 Pediatric Measurement 3 4 OneScan Feature 3 5 OneVision Feature 3 6 Orthopedic Hip Measurement 3 7 Quick View 3 8 Phantom Procedure 3 1 Measurement Overview amp Warnings Patient considerations Obey the patient considerations that follow before you start a patient measurement e Clothing restrictions Make sure the patient removes items that can attenuate the x ray beam such as clothing with zippers snaps buckles and buttons Ask patients to wear a jogging suit to the exam or give them an examination gown when they arrive e Radionuclide and radiopaque agents Make sure the patient has not ingested or been injected with radionuclides or radiopaque agents in the past 3 5 days If the patient has taken tests that use such agents postpone the measurement until all traces of the element have left the patient s body A 72 hour waiting period is usually long enough for most agents to leave the patient s body However consult your radiation safety officer RSO e Pregna
90. ient s body is in the center of the scanner table use the centerline on the table as a reference to align the patient Note If a patient is wider than the scan area the patient can be positioned for a half body scan In addition to all of the left or right side of the body the entire head and spine should be included in the scan window Page 49 of 138 B the patient s hands are turned on sides with thumbs up palms facing legs and arms are alongside the patient s body If possible hands should not touch legs Verify that the patients arms are within the scan area lines on the table pad C velcro strap 3 Select Position from the New Measurement tool bar The scanner arm moves to the approximate start position 4 Agraphic is shown that gives the correct patient position and measurement start position for the site you are measuring Remove the patient s shoes Make sure the patients head is approximately 3 cm below the horizontal line on the table pad Use the velcro straps to secure the patient s knees and feet to prevent movement during the measurement Note You are not required to adjust the scan arm position for Total Body measurements e Na Select Start from the New Measurement toolbar to start the measurement Monitor the image to make sure it is correct A correct Total Body image shows the patient s entire body Make sure the head 1 feet 2 and patient s arms 3 are shown in the image If the image is not correct
91. ilable for LVA Spine Geometry Reporting LVA Spine displays the LVA scan image and any Cobb Angle analysis Geometry Page 93 of 138 Dual VA displays the LVA and APVA scan images only This report is only Spine available if the exam contains both LVA and APVA scans Geometry Standard Dual VA displays the Cobb Angle analysis without images This report is only Spine available if the exam contains both LVA and APVA scans Geometry Ancillary Refer to Basic Analysis Procedures for additional Analysis information 4 12 Forearm Analysis 4 12 1 Forearm analysis procedure 1 Select an image file for analysis 2 If necessary select Imaging from the Analyze toolbar to adjust the image 3 If necessary select ROIs from the Analyze toolbar to adjust ROIs Make sure the forearm ROIs are positioned correctly as follows e 1 the Reference line is located at the distal tip of the ulna styloid process e 2the UD ROI does not contain the radial endplate e 3 the vertical lines in the center of the UD and 33 ROls are located between the radius and ulna Do not make any changes to the locations of the ROIs unless the program made obvious errors a Select Length and make sure the length of the patient s forearm is correct Icon Tool Description alif Length This option is shown after you select ROIs during a Forearm analysis Select Length to change the forearm length value b Select the Move Size ROI tool or the Rotate ROI to
92. iles Use the Ctrl key to select multiple images Page 128 of 138 5 Select OK to rebuild the database 5 7 2 Restore Backup Restoring from Backup will also restore your enCORE software settings and Composer style sheets 1 Select the Directory option from the window s tool bar in the directory screen 2 Select Database Utilities Restore Backup 3 Browse to the backup zip file location 4 Click OK Note Files are restored to the local database automatically when an archived image is opened If the file is kept on remote media the software will prompt the user for the appropriate archive disk If you desire to rearchive the file you must select Save while the image is open This will make the Archive operation available 5 8 Database Importing 5 8 1 Manual Import To manually import an individual scan select Directory at the top of the directory screen 1 Select Database Utilities 2 Select Manual Import from the list The current manual import options for manufacturers and scan type are as follows Hologic Lunar DPX Series IQ MD Lunar enCORE Systems Lunar Expert Norland note that Norland files need to be converted into Lunar format before importing This cannot be accomplished in the enCORE software 5 8 2 Import Supported Scan Types X Supported NA Not available Lunar Hologic DPX IQ Lunar Expert A Norland DPX MD y AP Spine X X X X X Left Right X X X X X Femur Dual Femur NA X X X NA Forearm NA X
93. ion If a scan is attempted without the scan arm locked into position the following error will be displayed x Error Description Swing arm not locked in scanning position Please lock before continuing Corrective Action Please try again If the problem persists contact GE Lunar Support for assistance To retract the scan arm once the scan is completed home the scan arm Pull the lever on the front of the scan arm towards you and push the scan arm to the left until it rests along the back of the scanning table The patient can then sit up and the table is free of obstruction The power switch is located at the head of the table There is also a roll at the head of the table to store up to 21 x 3 53 34 cm x 7 62 cm exam paper The table weight limit is 159 kg 350 pounds Swing Scan Arm Scan Arm Control Panel Bs Exam Paper Roll as and Power Switch head of scanner not shown Table Pad DPX Bravo The DPX Duo model also has mechanical features including stirrups procedure drawer storage drawers and patient step to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table Page 8 of 138 Swing Scan Arm in scanning position Table Pad Scan Arm Control Panel E Exam Paper Roll and Power Switch Storage Drawers Patient Step l head of table not shown Procedure Drawer DPX Duo Product Model DPX Pr
94. ion about the measurement modes is located in the Safety Information and Technical Specifications manual located in the Help topics 3 6 1 Position Patient I Select Position from the New Measurement toolbar The scanner arm moves to the approximate start position The patient should be centered and square on the table Page 56 of 138 Use the centerline on the scanner table as a reference The patient s arms must be crossed over the chest away from the side of each hip Place the foam knee positioner under the knee of the leg to be scanned with the tapered end toward the patient s thigh The foot of the leg to be scanned should be strapped to the vertical side of the foot brace The leg should be in a neutral position NOT rotated as in the femur scan You should also position the leg so the femoral shaft and implant are parallel with the centerline on the scan table Refer to the topic Measurement procedures for additional information 3 6 2 Adjust Measurement Start Position Use the graphic shown on the New Measurement screen Shown when you select Position from the New Measurement toolbar to adjust the position of the laser light Position the laser light mid thigh approximately 3 4 cm below implant tip Page 57 of 138 3 6 3 Start measurement Ve Select Start from the New Measurement toolbar to start the measurement Monitor the image to make sure the 1 scan Is initiated 3 4 cm below the implant tip 2 femoral
95. ition Y1 axis Composition Y2 axis Estimated Composition Trend and Pediatric Growth Trend HE Trend Table Options Flag Significant Change On or Off Configure how trending is C fe 7 Reference Data Tab Function Choices Choice of Reference Asia Australia Combined Geelong Lunar Australia Geelong Population Australia Lunar Brazil China Egypt Finland France Germany Indonesia Italy Japan Korea Mexico Middle East Philippine Spain Tunisia Turkey UK USA Combined BMDCS Lunar USA Combined NHANES BMDCS Lunar USA Combined NHANES Lunar USA Lunar Scan Site AP Spine Femur LVA Total Body Forearm or Lateral Spine Choice of Default Region Choose the region that will be the default region for analysis for each for Each Scan Type scan type 8 Image Tab Function Choices On or Off for Interpolation Invert Image Show bone edges Show Image Options Artifacts Size Image to Fit screen on Open Display On or Off Two Total Body images Dual Femur Images top bottom Composition Image for Total Body Image Colors Change image colors for ROIs Zoom Region Masks Bone Edges Point Typing Markers and Artifacts Image Export JPG Quality set Options Morphometry LVA Wizard Zoom Margin set in millimeters Wizard Options 9 ScanCheck Tab Select the ScanCheck items that you would like to show in the analysis screen 8 ScanCheck On or Off Page 28 of 138 a e le le le le i i AP Spine Aler
96. ks and will prompt the user to insert additional disks at the appropriate time if multiple image Page 132 of 138 files are being copied to disk The HIPAA Secure Copy feature removes all patient information from the file Select OK to proceed 4 Select the drive and folder to which you want to copy the file 5 Select OK once the location has been specified Note If you purchased the TeleDensitometry kit you can also use Send Image File to email image files Select Email in step 2 above The program opens a new email message and attaches the image file to the message 5 11 Change Image Type Another tool available to help you correct mistakes is Change image type This feature lets you change an image file from a left femur to a right femur a femur to an AP spine or an AP spine to a femur The image file must be closed before you can change the scan type 1 Select the image you need to change 2 Select Change Image Type from the Directory menu 3 Select the scan type to which the selected image should be changed 4 Select OK LUNAR does not guarantee valid results for images that were measured as the wrong site You should measure the patient again using the correct measurement site to ensure accurate results 5 12 Delete patient and Delete image ED 1 Complete one of the following e In the Patient list highlight the patient record and select Delete e In the Image list highlight the image file you want to delete a
97. lated using the Baumgartner equation 2 RSMI lean mass of arms kg Lean mass of legs kg height m 1 Harris JA Benedict FG A biometric study of basal metabolism in man Washington DC Carnegie Institute of Washington 1919 Carnegie Institute of Washington Publication 279 2 Baumgartner RN Koehler KM Gallagher D Romero L Heymsfield SB Ross RR Garry PJ Lindeman RD 1998 Epidemiology of sarcopenia among the elderly in New Mexico Am J Epidermiol 147 8 755 763 4 9 Lateral Spine Analysis Lateral Scans provide BMD values only 4 9 1 Lateral Analysis 1 Do not make any changes to the locations of the ROIs unless the program made obvious errors 2 Adjust the Body ROls using either the arrow keys or the mouse The Body ROI should be positioned with the top of the ROI just below the upper vertebral endplate and the bottom of the ROI just above the lower vertebral endplate e Each ROI should contain ONLY BONE e Do not analyze B4 if the pelvis covers part of the vertebral body e Do not analyze B2 if ribs cover part of the vertebral body e Do not adjust the point typing unless the program made obvious errors Select Points from the Analyze toolbar to adjust point typing Page 85 of 138 Lateral Bone Points Lateral Neutral Points Lateral Tissue Points 3 Select Results to view the new analysis results based on your changes 4 Select Save to save your changes or select Close then No if you do not want to
98. ly after completing an AP Spine scan WARNING Verify the patient s head arms knees or any body part are not in direct path of a moving scan arm 3 2 1 Step 1 Record or select patient To complete a patient measurement you must record information for a new patient or select a patient record from the database Select or Entor a paheni to Measure Fees Seeorcay Adare ra L Fabri 3 Efrem l Ser Dee LC T fa e As Heft ie E 7 Ha LC Be e S Hane waita f ie ee Record new patient information l i H 1 Select from the Main screen or Li from the Directory toolbar 2 Record the necessary information in the three tabs that are shown on the Patient Information dialog box e Primary tab You must record the patient s name birth date height and weight to complete a patient measurement Change the default gender or ethnicity in the Tools User Options Directory Directory Rules and Defaults e Secondary tab The Secondary tab lets you record comments and administrative information that is not required to complete a patient measurement If the ISCD guidelines are turned on under Tools User Options Systems it is important to enter a menopause age for postmenopausal women as the WHO criteria will only be applied to postmenopausal women and men age 50 and older e Additional tab The Additional tab lets you record fracture indication and treatment information for the patient In addition
99. mation on features and functions available with Physician Reports select the multimedia option within the enCORE software 4 20 1 Generate a Composer Report 1 With an analyzed exam open click on the right side of the Reports button 2 Select New Composer Report 3 Choose your report style sheet 4 Click Next 5 Preview Report 6 Save Report 7 Print or output Report 4 20 1 Physician Report Database New databases You can create more than one Physician Reports database For example if two doctors use the same scanner and each doctor uses different assessments then the doctors should have separate databases 1 Select Database from the Composer menu 2 Select New 3 Enter the filename for the new database 4 Select Save Change the active database 1 Select Database from the Composer menu 2 Select Open Page 110 of 138 3 Select the database you want to use 4 Select Open 4 20 2 Assessment Editor 1 Select Assessment Editor from the Composer menu The Assessment Editor window is shown The assessment categories are shown on the left side of the window and the assessment graph is shown on the right The assessment graph is divided into sections called assessment boxes The program uses these boxes to assign an assessment to the patient s results 2 Select the Category for which Assessment Editor d data reportgenerator mdb you want to record assessments Select the New button to create a Category
100. mber of copies for each page of the report User Information Includes the site name address phone numbers web site and email information Page 24 of 138 Morphometry Report Options are configured here Composer Configure the file type to output from Composer Use the Spelling Options to customize spell checker functions Use this option to change the default setting for printing QA reports Select Automatic Printing Daily QA to have the program print a QA report each time you complete a quality assurance procedure Select Automatic Return to Trend Screen to automatically return to the trend screen once a QA has completed Use this option to set the default settings used during a measurement Save prompt at end of scan select this option to show a message after every measurement that asks you if you want to save the measurement Allow continue after SmartScan abort Use Old Positioner for Lateral Measurements Densitometry and Morphometry Only Show Previous Scan Allow Scanner Start Button to initiate a Measurement LVA reverse For LVA scan patient facing foot of table Default to seated patient for forearm and hand scans Pause between Femur scans OneScan no Foam Leg Block positioner for AP Spine scans or Pause between AP Spine and Femur Scans 2 Systems Tab The scanner s System ID is unique The System ID is needed for support The feature code is only compatible with your system ID It enables the purchased o
101. mportant if your files are stored in a database that is used by several workstations Only one workstation should be used to archive all of the files in the database DO NOT allow files to be archived from more than one workstation Backup Drive Designate the drive to be used to backup database and configuration Allow Backup from this workstation Change the backup permission for this workstation A check mark in this box means backup is allowed on this workstation Each workstation may be used to backup configuration files in the database Page 127 of 138 5 6 Archive a Select Archive to copy image files from your computer hard drive to an archive location Select the method of Archive e archive all exams for all patients e archive all exams for all patients in the current search results e archive all exams for selected patient e archive selected exam Refer to Edit Database to change the destination for the archive drive Use the task scheduler found under Tools Task Scheduler to set up automatic archiving The default Archive function is to Copy the image file to the Archive location The original image file remains in the database directory You may choose the option to Move the image files to the Archive location When Move Archive is used the image file is moved to its archive location then deleted off the local drive Select the More gt gt button to change the Archive behavior and view Advanced Settings 5 6 1 Archive Advance
102. mposition Trend Information Composition Trend Total Fat ibs Lean bs Magenta A8 BD 63 80 34 60 83 60 34 40 43 40 34 20 83 20 34 00 43 00 29 30 31 32 1 Age years 3 e a Region Total Trend Qn Fat lbs Display Absolute Value MM Trend On Lean ibs Z Ze Page 77 of 138 1 Choose Region to trend from drop 2 Choose a Display option down menu Display Veit E 7 Region Total 7 beclts V 3 If Change vs is selected for Display A If Absolute Value is selected for the Display option choose a Trend On option option two Trend On options will appear for for Y1 only This will plot Change Y1 and Y2 Y1 is represented in black and vs Previous or Baseline for Y1 will appear on the left axis and Y2 is represented in magenta and will appear on the right axis Trend On Total Mass bs d bs Tend On eis yi Fat Free lbs Lean lbs Trend On Le be ei V2 Region Thai Jee za Tissue bs Additional Trend On options A G Ratio and Total Total Mass fbs Body Fat are available Trend On Fat he 7 ING Rat Trend On er Line Pattern and Change vs Previous or Baseline options are set under Tools User Options Trending Trend Graph Options Page 78 of 138 User Options Eg vd Systems T TER Trend Graph Options e Analyze 2 Trend Graph Options A Trending Line Pattern F Reference Data Kee EE Densitometry Graph Fa i Dame G Percent Change v
103. n tab gives information related to the scan parameters Composition tab Total Body composition or Spine Femur estimated composition AHA tab Femur Advanced Hip Assessment gives information about hip axis length and hip strength results e Morphometry tab Refer to LVA analysis or APVA analysis for more information 1 3 2 Analyze toolbar Select tools from the Analyze toolbar to complete analysis procedures Refer to specific scan types for detailed analysis recommendations for each measurement site Page 16 of 138 General Analysis Tools a Imaging Select to adjust contrast and zoom the image file 3 Ctrl I 2 ROIs Select to position ROIs during analysis Move and size ROI as well wm Ctrl R KI Delete Use this option to delete an ROI ROI E Move ROI This tool allows an ROI to be moved a Rotate Select this tool to turn an ROI in a circular motion SS ROI Fi Move Select this tool to move a vertex of an ROI Vertex SL Label May be used to label an ROI e ROls f Points Select to verify that bone and tissue samples are correctly classified F4 DO NOT adjust point typing unless the program made obvious errors CH Reset This option is shown after you select Points Select Reset to delete La F3 changes you made to point typing Copy Use this option to copy ROls from an existing image file to the F5 current image file ancel This option is shown after you select ROIs or Points Select Cancel Esc to delete changes you made t
104. ncy restrictions If it is necessary to measure a pregnant patient the fetus could be exposed to small amounts of radiation Postpone the measurement until the end of pregnancy if clinical management is not affected The decision to subject a fetus to radiation exposure must be made by the referring physician noting that 1 bone quality for most patients does not significantly change during pregnancy and 2 in the advanced stages of pregnancy the fetus mineralized bone can interfere with measurements of the mother s spine and femur Measurement Warnings WARNING Each GE LUNAR scanner is equipped with a Class Il Laser that is less than 1 milliwatt in strength DO NOT STARE INTO THE BEAM WARNING Remove Foam Leg block prior to positioning scan arm over the patient and immediately after completing an AP Spine scan WARNING Insure the patient s head arms knees or any body part are not in direct path of a moving scan arm Page 37 of 138 3 2 Measurement Procedures This section describes the basic steps necessary to complete a patient measurement These steps must be completed in the order given Review the steps before you start a patient measurement Note the following whenever you see the following symbol WARNING Each GE LUNAR scanner is equipped with a Class Il Laser that is N less than 1 milliwatt in strength DO NOT STARE INTO THE BEAM WARNING Remove Foam Leg block prior to positioning scan arm over the patient and immediate
105. nd select Delete 2 A message box is shown which gives you the option to Select Delete patient or exam to delete patient records and image files e Delete Selected Patient and Associated Exams This option deletes the selected patient in the Patient lists and all images associated with the selected patient or e Delete Selected Exam This option only deletes the exam selected in the list or e Delete Selected Image This open only deletes the image selected in the list e Delete Database Record Only This recommended option removes the connection of the image file from the database or e Delete Database Record and Exam File s This option permanently removes the patient and or exam file and database connection 3 Select the necessary option and select OK Page 133 of 138 5 13 Edit Patient and Edit Image i Select Edit to update patient exam records and image files 1 Complete one of the following e In the Patient list highlight the patient record you want to edit and select Edit e In the Image list highlight the image file you want to edit and select Edit 2 Inthe Edit Information dialog box that is shown change the necessary patient information and select OK Note For editing individual image files patient information must be modified for each image 5 14 External USB Hard Drive USB external hard drive may be used with the enCORE system as an archive and or backup device Contact your local GE represent
106. ne ROI Use the left mouse button to click on the image then drag the cursor Select to create a Point ROI Use the left mouse button to click on the image and create a point Select to add a vertex to an ROI Use the left mouse button to click on an ROI and add a vertex Select to remove a vertex from an ROI Use the left mouse button to click on a vertex and remove it Select to move an ROI vertex Use the left mouse button to click on a vertex then drag the cursor Use the tools given below to create and open templates of custom ROIs The tools are shown in the Analyze toolbar at the top of the Analyze window after you select ROIs Icon Tool Description Select to open a template from a previous Open Custom ROI Template custom analysis Save Custom ROI Select to save the custom ROIs as a Template template Page 121 of 138 4 24 FRAX 10 Year Fracture Risk FRAX 10 Year Fracture Risk Provides an estimate of 10 year fracture probability of hip fracture and 10 year probability of a major osteoporotic fracture clinical spine forearm hip or shoulder fracture for men and post menopausal women ages 40 90 years This estimate is based on the patient age gender population ethnicity height weight femur neck BMD T score and the presence or absence of several risk factors and computed using the FRAX model endorsed by the World Health Organization WHO T scores are based on the NHANES reference values for wom
107. ner Button IDXA Front Panel The enCORE software is used to operate the X ray Bone Densitometer the following chapters describe how to use the enCORE software Note Daily Quality Assurance procedure Complete quality assurance procedures daily Make sure each QA procedure passes Refer to Chapter 2 for detailed instructions Make sure you save your printed results for future reference Archive image files Archive your image files before you leave for the day Refer to Chapter 5 for detailed instructions Shut down computer At the end of the day select Exit from the Main screen and select Exit enCORE from the close window to close the program Then shut down the computer Note Do not turn off the scanner at the end of the day for stationary systems Some of the functions of the enCORE are not available for all X ray Bone Densitometer models Classifications Protection against electric shock Class Type B Protection against water IPX0O Operation mode continuous operation with intermittent loading The device can neither be used in flammable anesthetic mixture with air or non flammable anesthetic mixture with oxygen or nitrous oxide Page 13 of 138 1 0 Screens and Toolbars Overview Main Screen Analyze Screen Directory Screen New Measurement Screen Quality Assurance Screen Options meek ech sch sch ech zl OO Om P GND 1 1 Overview This section describes the screens and toolbars that are shown throughout
108. o NT MD DPX Pro NT MD models come in full and compact sizes and use pencil beam technology with a single crystal channel Nal detector The power switch is located on the lower front panel The table weight limit is 136 kg 300 Ibs Scan Arm Control Panel Table Pad Power Switch Page 9 of 138 DPX NT Product Model Prodigy Pro Primo Advance Prodigy models come in full and compact sizes and use fan beam technology with a 16 channel solid state detector The power switch is located at the foot of the scanner The table weight limit is 159 kg 350 Ibs Scan Arm Control Panel Table Pad ww Power Switch Prodigy Series Product Model iDXA The Lunar iDXA uses fan beam technology with a 64 channel solid state detector and is a scanner designed for optimal image quality and supports patient s weights to 204 kg 450 Ibs The power switch and exam paper roll is located at the head of the scanner Scan Arm Control Panel Exam Paper Roll and Power Switch Table Pad head of scanner not shown IDXA Page 10 of 138 The Warning label identifies the location of possible pinch points When the scanner arm is in motion make sure possible pinch point areas are clear at all times The technologist must keep their feet away from the moving carriage Patient limbs must remain inside the boundaries of the table top to avoid a pinch between the scanner arm and table Installation and Operation Onl
109. o need an account set up on SQLServer that has the authority to create and modify databases typically an administrator account because enCORE does do such operations for things like New Database Backup Restore etc Typical day to day operations of course can be done with an account that has much more limited authority 3 Network speed requirement Expected network speeds for a database of 10 000 patients is approximately Directory Search for 1 patient 1 sec Directory search for all patients 44 sec Open single image S00Kb Prodigy or 3Mb iDXA 9 sec Save single image 23 sec e Cat5 enhanced rated cables to handle Base100 e No external programs write update the shared database e No external programs reading encore database while the enCORE program is running on any system e All systems sharing the database must be upgraded simultaneously 5 15 2 Integrate Existing enCORE Database with SQL Service 1 Make note of the working path With the database still selected look at the Working Path line under Active Database Write down the working path for future reference 2 Remove the connection to the Access database With the database still selected select Directory Database Utilities Delete Entire Database Select OK Leave the selection on Just remove database connection and press OK 3 Create a new SQL Server database Select New Database in Directory Select the Microsoft SQL Server option Enter the
110. o the image file Results This option is shown after you select ROIs or Points Select Results Enter to view analysis results for the image file Report Select to create analysis reports for the image file Ctrl Shif t P KL Save Select to save the image file and data to the patient database i Ctrl S Close Select to close the image file isl Esc ROI Tools Icon ROI Tool F ROIs Select to position ROIs during analysis Move and size ROI as well ge Ctrl R Delete ROI Use this option to delete an ROI E Move ROI _ This tool allows an ROI to be moved FE Rotate ROI Select this tool to turn an ROI in a circular motion Di Add ROI AP Spine dn Move Select this tool to move a vertex of an ROI ew Vertex 7 Label ROIs May be used to label an ROI Cancel This option is shown after you select ROIs or Points Select Cancel ke Esc to delete changes you made to the image file Page 17 of 138 Imaging Tools Image Description Tool Imaging Select to adjust contrast and magnify the image file Ctrl I Points Select to verify that bone and tissue samples are correctly F4 classified DO NOT adjust point typing unless the program made obvious errors S Reset This option is shown after you select Points Select Reset to delete F3 changes you made to point typing Copy Use this option to copy ROls from an existing image file to the F5 current image file l Cancel This option is shown after you select
111. of the ruler may be relocated for a measurement The Length icon provides the opportunity to modify the length of the implant The software automatically calculates a length based on the automated ruler measurement The Length feature also includes a Find button which prompts the software to search for the implant edges based upon the ruler position Page 97 of 138 lt is recommended that the top of Gruen zones 1 and 7 align with the shoulder of the implant Upon entering the ROI screen the Gruen icon is selected and all ROIs are active This allows the user to move all regions at the same time However the user has the option to move each zone individually if desired 4 15 Pediatric Analysis Pediatric analysis is a purchased option Reference data is available for U S and European populations Reference data is limited to AP Spine Femur and Total Body analysis Z scores and percentages are used to compare the pediatric patient to their peers Pediatric patients have not yet reached their peak bone densities 4 15 1 Pediatric Total Body Analysis Pediatric Total Body will provide reference data for U S and European reference populations The BMD of the head appears to dominate the Total Body BMD in children To enable the feature to omit the head ROI select Tools User Options Analyze Total Body Analysis Options Check the option box Click OK Select Regions or Omit Region on DXA Report To select regions or omit the
112. ogram but do not want to permanenily disable the database Also permanently delete database removes the database name from the program and deletes the database file from the database folder 4 Select one of the options and select OK NOTE Patient image files are not deleted from the database folder when you use the Delete Entire Database option 5 4 Edit Database IS Select Edit Database from Database sidebar in the Patient Directory screen If the utility is not visible click on the More gt gt button The Edit Database dialog box gives the options that follow Note Name Change the name of the active patient database used to store patient records Archive Drive Change the drive location that is used to archive files Archive Number Change the number that is given to the current archive disk This number is used to identify the archive disk that contains your patient image files during the archive procedure Allow Archive from this workstation Change the archive and Backup permission for this workstation A check mark in this box means archive is allowed on this workstation This setting is important if your files are stored in a database that is used by several workstations Only one workstation should be used to archive all of the files in the database DO NOT allow files to be archived from more than one workstation Allow Backup from this workstation Change the Backup permission for this workstation A check mark in
113. ol and move the Reference Line to the correct location All the ROIs move when you move the Reference Line Page 94 of 138 c If the radial endplate is included within the UD ROI move the UD ROI to just proximal the endplate DO NOT move the 33 ROI after you correctly position the Reference Line The program positions the 33 ROI based on the location of the Reference Line 4 If necessary select Points from the Analyze toolbar to adjust point typing DO NOT adjust the point typing unless the program made obvious errors If you adjust point typing select Results to view the new analysis results based on your changes Bone Points Neutral Points Tissue Points Fa e F 5 Select Save to save your changes or select Close then No if you do not want to save your changes Refer to Basic Analysis Procedure for additional Forearm Analysis information Page 95 of 138 4 13 Hand Analysis 4 13 1 Hand analysis procedure 1 Select Imaging from the Analyze toolbar to verify point typing 2 Select ROI is from the Analyze toolbar to adjust ROIs Make sure the hand ROIs are positioned correctly as follows The enclosed area includes the entire hand to the tips of the fingertips and ends at the ulna styloid process The ROI should include the carpal bones but not the ulna or radius 3 Select the Move ROI tool or the Move Vertex tool to adjust the edges of the region of interest Icon Togo Description gt o S o Pe Move ROI Sele
114. old tool if necessary to adjust the threshold of the tissue and bone gt point typing This is for research only 5 Select Save to save your changes or select Close then No if you do not want to save your changes Page 101 of 138 4 16 2 Small Animal Body Tissue Quantitation Tissue quantitation is part of the Small Animal Body analysis The program reports lean and fat tissue quantities Composition results are shown on the screen when you select the Composition tab in the Analyze window The program prints a Composition report if you select the Composition report option in the Reports dialog box Use the cut positions to define the tissue regions Adjust cuts as necessary to include all of the tissue in the appropriate regions Be very careful to separate the arm regions from the tissue in the hips and thighs Refer to Custom Analysis Procedures for additional Analysis information Page 102 of 138 4 17 Custom Reference Population You can create a custom reference population and use that population for comparison to your patients results After you create or edit your custom reference population you can select it for analysis by selecting the Tools menu selecting User Options selecting the Reference Data tab and selecting the population from the drop down list Caution Invalid reference data may result in an incorrect comparison by the physician 4 17 1 Create a New Reference Population 1 Select Custom Reference Data
115. on the assessment graph Move the mouse cursor over the assessment graph and click once to add or remove a break line 4 Select the Text tab to record assessments recommendations or follow up for the new boxes Page 112 of 138 4 20 3 Style Sheets enCORE software includes a style sheet designer that enables a user to create a personalized physician report Create a physician template or use one of the templates provided Save Report Ctrl S Report Center Ctrl Shift P Print Preview Ctrl Shift V Print Preview ee e Spell Check F7 Insert Auto Text Create New Auto Text Edit Auto Text Edit Insert Field Switch Between Headers and Footers Show Previous Header Footer Show Next Header Footer Set Header Footer Properties Edit Create Style Sheet 1 Select Style Sheet from the Composer menu 2 Select New to create a new style sheet or Open to open an existing style sheet 3 Record the information you want to use in the reports e The style sheet works in a similar manner to any word processor with options such as cut copy paste and header footer options e The program will use field codes in the report if you select the Field Insert toolbar button and then select field code options Page 113 of 138 NOTE The user may modify the sequence of indications comments etc and insert images and tables in the report for easy editing viewing The user may open the default style sheet included with the software Make
116. on tissue e Total mass in kilograms or pounds e Grams or pounds of soft tissue fat tissue and lean tissue e BMC in grams or pounds e Centile or Z score e BMI Options for Centile or Z score and Metric or English US results are found under Tools User Options Results Display Composition Options The program prints a Composition report if you select the Composition report option in the Reports dialog box Use the cut positions to define the tissue regions Adjust the cuts as necessary to include all of the tissue in the appropriate regions Be very careful to separate the arm regions from the tissue in the hips and thighs Note Estimated Total Body Fat is only available with OneVision Exams comprised of AP Spine plus Femur Left Total Right Total Regions The option to generate total left and total right regions is located in Tools User Options Analyze Total Body Analysis Options Check the option box to enable Calculate Left Right Total Body results Page 75 of 138 4 8 1 Composition Measurement of Android and Gynoid Fat Android and Gynoid Composition ROIs are available in analysis Basic ROI descriptions Android ROI Lower boundary at Pelvis cut Upper boundary above Pelvis cut by 20 of the distance between Pelvis and Neck cuts Lateral boundaries are the Arm cuts Gynoid ROI Upper boundary below the Pelvis cut line by 1 5 times the height of the Android ROI Gynoid ROI height equal to 2 times th
117. onditions Tscore A c Cancel The user must also insert the criteria for the condition A list of conditions will default to an And command to combine the conditions listed However the user has the opportunity to select an Or command or define multiple conditions within parenthesis for multiple And Or combinations The user may also Edit or Delete conditions by selecting the condition and choosing one of these tools Select OK once you have completed all conditions for the query The recently created query is available for selection in the list of report types Select Next to advance to Available Report Types Editing Queries Select Edit from the Practice Management dialog to make modifications to the name description or any conditions associated with the report Once the user selects Edit the software will guide the user in editing the report query The first dialog that is displayed provides the user the opportunity to modify the Name of the report or the Description associated with the report Once again it is highly recommended to use a naming method for the reports that makes the report easily identifiable Next the software allows the user to modify any conditions associated with the report including the criteria for each condition and how each of the conditions are handled The user may add conditions edit the existing conditions and delete conditions Select OK once all modifications have been
118. onditions simpler Practice Management dialog is divided into three areas 1 Tools for Adding Editing and Deleting queries Add Edit Delete Site Region Filters History Catalog 2 Available reports and their description Select a Report 3 Options for proceeding forward and or backward through Business Report wizard Next Back Cancel Page 106 of 138 4 19 2 Adding Editing and Deleting Queries Upon entering the Practice Management Tools Select Report window appears where you may Add Edit and Delete Reports as well as set BMD Site Region Filters and view the History Catalog Adding Queries Select Add from the Practice Management dialog This prompt will allow the user to choose a name for the query and enter a description of the criteria for the report It is highly recommended to use a naming method for the reports that makes the report easily identifiable For example if you are creating a report that will include all patients over 50 that have a T Score of less than 2 0 the report would be easily identified as Over 50 and T Score less than 2 0 However the user has the option to enter any name The conditions defined here will be used to produce the patient list when generating a report Select Add and the Add Condition dialog box appears The user may select from the drop down menus for the condition Only the conditions displayed are available i e the user is unable to enter their facility specific c
119. option to change the default settings for the HL7 feature The Worklist Mode feature displays a list of patients who are scheduled for DXA measurements The list is supplied by the hospital information system The Reporting option can send Text and Images in HL7 format DO NOT change any of the HL7 default settings without authorization from your network administrator The HL7 option is only available if you purchased the HL7 kit Support This option lists the fax and email information for your service provider The program uses this information to email or fax QA reports to your service provider if the QA procedure fails 1 7 3 Error Log In the event you encounter difficulties which prevent normal operation of the program view the Error Log for a list of errors that may be causing the problem Service will need the digital file of errors 1 To view the Error log Select Options B F6 from the Main screen and select Error log OR Select the Tools menu and select Error Log 2 To export the error logs go to Tools Send Configuration and check the options to export The Error log consists of two sections e Sessions This section lists the dates and times that the program was being used and the number of errors that occurred during each session e Errors This section gives a description of each error that occurred during the selected session Page 33 of 138 Troubleshoot button takes you to a help topic about the selec
120. ositioner B 1 should be placed on top of the spine strap 2 and against the back rail of the table 2 The lateral positioner and the instructions below are intended to position the lumbar spine straight and parallel to the scanner table Refer to the figure below to complete the steps that follow e Seta pillow on the table for the patient s head e Position the patient s knees toward the chest until the lower back and both shoulders are flat against the lateral positioner e Make sure the patient s spine is parallel to the scanner table Page 45 of 138 3 Positioner A Refer to the figure below to complete the steps that follow for Positioner A Place a pillow under the patient s head Set a foam wedge below the bottom knee and between the knees for comfort Make sure the patient s back and hips are flat against the positioner Patient s arms should be 90 degrees from the chest 4 Positioner B Refer to the figure below to complete the steps that follow old Positioner B e Pull the compressor strap over the patient s torso and secure it to the back of the positioner Make sure the strap does not hang over the back edge of the scanner e Seta foam wedge between the patient s thighs and the bottom of the positioner Set a second wedge between the patient s knees and set a third wedge below the bottom knee Make sure the patient s back is flat against the positioner and adjust the strap so t
121. ou can select the information shown in the results tables select the composition results to show and set the Morphometry SD cutoffs Trending Use this option to select the type of information shown on trending graphs and in ES trending tables and configure the software to flag significant change The integrated Precision Calculator Tool is also located within this option Reference Use this option to select a reference population and show the reference sources on Data the screen and the results reports Use of the reference population comparisons is fully at the discretion of the clinician The program does NOT show the am comparative values when shipped from GE Medical Systems LUNAR Image Use this option to set the colors of ROIs bone edges and point typed areas of an Q image file during analysis and enable optimal image magnification scanCheck Use this option to select the ScanCheck checks that will be included on the A ScanCheck tab for AP Spine Femur Forearm and Total Body analysis Reports Select Patient ID types and Report background color Under Dexa Report ie Configurations select to report on Selected Region Only Trend Multiple Results Invert Image GE Healthcare Logo Report Dialog sBMD Footnote Comments Show Vertebral Height T Scores and Show Ethnicity Change the Report Center Defaults where the report will be sent the types of reports that will be created regions to be reported on and the nu
122. ous surgical interventions The operator should pay particular attention to the location of the patient s arms keeping the positioning the same for each scan Results may be affected if the patient moves during the scan Precautions for Standard Operating Procedures e Do not attempt to operate the scanner without first reading this manual e Do not remove the assembly panels or attempt any repairs without prior instructions from authorized GE Medical Systems Lunar personnel e Do not sit or lie on the scan table for purposes other than scanning e Perform the Quality Assurance procedure each morning If any test fails check the position of the calibration block and rerun the QA procedure If a test fails again contact GE Medical Systems Lunar Support Also call GE Medical Systems Lunar if more than two failures occur in a one week period Page 5 of 138 If the patient is or might be pregnant always contact the patient s physician before performing a scan Remain in the room with the patient while a scan is in progress Restrict access to the room to authorized personnel Do not attempt to service any of the system s electrical components while the scan table is turned ON High voltage is used to produce x rays Radiation safety information is located in the safety and technical specifications manual you received with your system e To stop the scanner in an emergency press the emergency stop button on the scan arm DO NOT use the emergency
123. own on the New Measurement screen to adjust the position of the laser light If necessary move the positioner and the patient s arm so that the laser light shines in the center of the wrist adjacent to the ulna styloid All of the Ulna Styloid is visible Let scan Laser Light In center of wrist adjacent proceed past all to ulna styloid fingertips 4 Ne Select Start from the New Measurement toolbar to start the measurement 5 Monitor the image to make sure it is correct Make sure the scan proceeds past all fingertips and make sure that all of the ulna styloid is visible If the image is not correct select Abort and reposition the patient ESCH 6 if you have completed measurements for the subject select Home to move the scanner arm to the Home position f LN Select Close to exit the New Measurement screen Refer to the topic New Measurement screen for additional screen functions 3 2 10 Small Animal Body Measurement Option CAUTION This software is for investigational use on laboratory animals or for other tests that do not involve human subjects WARNING Proper cleaning and handling procedures must be followed to prevent the N possibility of cross infections between subjects scanned on the same system Clean and disinfect the system according to your local and country specific hygienic regulations Protect table pad and table top from wetness and prevent the ingress of liquid into the scanner by protectively covering t
124. population data is not available Custom Analysis results are to be used for investigation purposes only Select an image file for analysis Select Imaging from the Analyze toolbar and adjust the image if necessary Select Custom from the Analyze pull down menu LH Select ROIs from the Analyze toolbar Use the Custom Analysis tools to create and adjust ROIs Select Results to view analysis results for each ROI created Select Save to save your changes or select Close then No if you do not want to save your changes NOOR Wh Custom Analysis toolbar Use the tools given below to create custom ROls for image files during Custom Analysis The tools are shown after you select ROIs Page 120 of 138 P F ISBN HSN Tool Delete ROI Rotate ROI Move Size ROI Create ROI Shape Create Point Insert Vertex Delete Vertex Move Vertex Description Select to remove an ROI Use the left mouse button to click on the ROI then select the Delete ROI icon Select to Rotate an ROI Use the left mouse button to click on an ROI then drag the cursor Select to move or size ROIs To move an ROI click on the ROI and then drag the cursor To change the size of an ROI click on an ROI handle and then drag the cursor You can create four different ROI shapes Rectangle shown at left Circle Ellipse or Polygon Select a shape use the left mouse button to click on the image then drag the cursor Select to create a Li
125. pproximately 3 of the measured value for males and females The estimated Total Body Fat estimates are only valid for Caucasian and Asian patients The estimated Android and Gynoid Fat estimates are only valid for Caucasian patients Patient s age weight height BMI and spine and femur measurement values fall must fall within limited ranges see below for details Caucasian Range Limits for Valid Total Body Fat Estimation Variables Predicted Femur Total Thickness Body Page 81 of 138 Caucasian Range Limits for Valid Android amp Gynoid Fat Estimation Variables Limits Height Weight Spine Spine Femur Femur Predicted Gynoid A G Android cm kg Fat Thickness Fat Thickness Total Body Fat Ratio Fat a In addition to the above fixed ranges for Total Body Android and Gynoid Fat the spine thickness values should fall within limits which vary with BMI which are given in the equations below BMI is calculated from the entered height amp weight Caucasian Female spine tissue thickness cm 9 014 5 214V BMI 3 8 cm Caucasian Male spine tissue thickness cm 6 726 5 199V BMI 3 0 cm Android and Gynoid Fat has an additional limitation Spine Thickness Femur Thickness 1 46 Asian Range Limits for Valid Total Body Fat Estimation Variables Spine Femur Predicted Limits Height Weight Spine Fat Thickness Femur Thickness Total Body Et SC ees e wm cm Fat a a ie ees In ad
126. ptions in your software If you wish to try out a feature before buying it contact your sales person for a trial feature code Icon Function Choices Additional Enter Trial and IRB feature codes Expiration dates will display below Feature each feature code Codes User Automatic return to Directory will return your display back to the Interface Directory scan after an acquisition is complete Options HIPAA Secure View hides patients in the directory view Play Multimedia Sounds option Auxiliary Workstation for use with MUDBA setups The Auxiliary Workstation option is shown if you purchased the Multi User Database kit Select this option to prevent the workstation from performing QA procedures or patient measurements The Number of Open Exams option lets you choose how many exams can be opened for analysis at the same time rl Exam HIPAA Secure Filename On pat_z8gutml1 w dff File HIPAA Secure Filename Off SmithJfOm485s dff 7 Options Compress Exam Files to conserve space for high resolution images such as IDXA scans Encrypt Exam Files Page 25 of 138 a Wi ISCD Official Position Acceptance FRAX 3 Directory Tab Function Patient Sort Options Exam Sort Options Patient List Columns Directory Rules amp Defaults Directory Status Select Yes to accept the settings recommended by ISCD Review current ISCD Positions from the link in the enCORE software Check box s for Enable FRAX
127. r Reports nno0000aennenoo0aaaeneeoooonnnnnennoronnnnnerrrnnnnnnrerrrnnnnneneneenne 110 4 21 DXA Results Heport EE 114 4 22 Precision Calculator cccccccsssseecccceeeeeseesseeeeeeeeseeeeeeeeeeeessaeeeeeeeeeeeeaaas 118 423 EIERE 120 4 24 FRAX 10 Year Fracture Hiek 122 5 0 Database Maintenance ccccccseecccecceeeseeeeeceeeeeeeeesaeeseeeseeaeeceeessaaseeeeessaeeeees 124 5 1 Maintenance Hrocecdures eserita a a 125 52 EE Eege 125 5 9 Dellt Oger 126 54A Edit DataDA E 126 59 New EEN 127 We E 128 Page 2 of 138 5S7 Rebuld ler 128 0 6 Dalabase eet ue xcs epee eee ee Oe ee 129 Bi MOVE EE 131 510 GOD VOX ANID UE 132 SAT Change Imago TYDE E 133 5 12 Delete patient and Delete mae 133 5 13 Edit Patent and Eet Mage eg cies ivanceitatinavelwehiweniau Eet 134 9214 extemal USB Hard Div EE 134 5 19 SOL Database Met TEE 134 Ol ask Scheduler ee 137 pl Baich Exam lee 137 LLE EE 138 Page 3 of 138 Caution United States Federal law restricts this device to sale by or on the order of a licensed physician This is required per 21CFR801 109 code of federal regulations The information in this manual is subject to change without notice You may use or copy the software described in this manual only in accordance with the terms of your software license product warranty or service contract agreements No part of this publication may be reproduced for any purpose whatsoever stored in a retrieval system or transmi
128. rm measurement 1 Put the forearm positioner on top of the pad The LUNAR logo should be located near the patient s fingers The forearm positioner keeps the patient s forearm from moving during a measurement 2 Seat the patient in a chair next to the scan table Note Use a chair without arms or wheels Use the same chair for all forearm measurements to get optimal precision Note Lunar iDXA and Prodigy scanners have an option to scan the patient in a non seated position with the scan positioner under the forearm Tools User Options Measure tab Continue to use the same method of positioning If previous scans were done in a seated position continue to use the same scanning method to trend data Page 43 of 138 3 The arm is placed on the positioning board with the palm down with the hand near the Lunar label 1 Tell the patient to make a loose fist The red line 2 shows the center of the measurement area Center the patient s forearm along this line The black lines 3 show the boundary of the measurement area Position the patient s forearm so that both the radius and the ulna are between these lines The blue line 4 shows the starting point of the measurement Position the patient s forearm so the distal end of the ulna is at this line Position the laser light at this line 4 when you start a measurement 4 Attach the velcro straps over the fist and over the arm immediately below the elbow The straps must be outside th
129. s A CAD e Reference when available Gg Axis Automatic Scaling ai Reports l e 2 IW X Axis Automatic Scaling QA Morphometry Graph Een Ge Percent Change vs Previous sl Measure a Absolute Value Composition Graph Percent Change VC Previous ke c OK Cancel Display Y1 and Y2 options can also be changed under Tools User Options Trending Page 79 of 138 EY User Options i Systems ji ZS Trend Graph Options Es Analyze Trend Table Options Results Display A Trending Precision Calculator F Reference Data Trend On e Try Sw image Densitometry Pediatric m ei A Cap Densitometry Adult gmp Ze Reports Morphometry Average Height E Composer 7 Composition Trend Display absolute Value ll r OA Composition Y 1 Fat lbs e Measure s Composition 2 Lean lbs Estimated Composition Trend Tissue Fat i Pediatric Growth Trend Absolute Value Y1 Height for Age aq Composition trending tables will display the Composition Trend of the region selected and the Fat Distribution 4 8 4 Composition Report Options Composition Ancillary Report In addition to the main Composition report enCORE also features a composition ancillary report The Ancillary report page includes fat mass ratios of Trunk Total Legs Total and Arms Legs Trunk Enhanced Composition Report enCORE also features an Enhanced Composition option Thi
130. s Relerence BMD TA All Region g cm T S5corwe Z 5Score Meck Debt ZU L i Upper Heck TTT TTT AE Lower Heck 0 540 Page 71 of 138 4 6 6 Hip Strength Provides an index of hip strength by combining BMD Femur Geometry Age Height and Weight The Hip Strength Index is derived from published information from the Journal of Bone Mineral Research 1994 article entitled Geometric Structure of the Femoral Neck Measured Using Dual Energy X ray Absorbtiometry Hip Strength Index strength stress where strength 185 0 34 age 45 Age gt 45 years stress moment y CSMI force CSA moment d1 8 25 weight 9 8 height 170 cos 180 0 force 8 25 weight 9 8 height 170 sin 180 8 d1 Distance along the neck axis from the center of the femoral head to the section of minimum CSMI y Distance from center of mass to the upper neck margin along the section of minimum CSMI theta 0 Angle of the intersection of the neck and shaft axes The value is not for clinical diagnosis of disease Hip Strength Results Fa ere lt eee ne ES Pe Index mma mm2 mm mm mm mm degrees degrees EE mm md EE Page 72 of 138 4 6 7 Hip Geometry Definitions CSA CSMI Alpha a Theta 9 y d1 d2 d3 Cross sectional area Cross sectional moment of inertia Angle of shaft axis with respect to vertical Shaft neck angle Distance from the center of ma
131. s is available to ensure correct analysis facilitate interpretation by doctor and make an integrated assessment The user must apply their own knowledge and judgement to determine if there are any potential problems with the image measurement analysis or repeatability 4 18 1 ScanCheck Tab When the ScanCheck tab is active the identification of artifacts incorrect analysis etc is displayed to the right of the analyzed image The ScanCheck tab gives the technologist a checklist of items to confirm and or correct during the analysis The tab includes a series of Yes No questions with space for comments If the software has ScanCheck those indicators will be displayed within the checklist Any ScanCheck component may be disabled under Tools User Options ScanCheck tab 4 18 2 ScanCheck Checklist The software verifies areas regarding measurement analysis and anatomy and breaks the ScanCheck checklist into these three categories for the measurement site This should be used to analyze the image and make corrections where necessary Click on a ScanCheck warning to display a dialog with further instruction for correcting the specific ScanCheck warning For the AP Spine Measure the following areas are verified and or identified e Verify mode is correct for patient thickness e Verify spine is aligned Example ScanCheck is indicating a potential problem A Patient thickness is outside the range for this mo
132. s report provides the Composition Reference Graph a Composition Trend Graph a Fat Distribution Table and the WHO BMI reference chart 4 8 5 Estimated Total Body Fat and Android Gynoid Fat Using the scan tissue data from standard spine and femur scans it is possible to make an estimate of the total body Fat and Android Gynoid Fat The required scan types are as follows e Anexam with AP Spine and a Femur e An exam with AP Spine and Dual Femur averaged value A Composition tab in the analysis screen for Spine Femur exams displays a reference graph BMI graph and table that includes Tissue Fat Tissue Y Lean and Centile Page 80 of 138 CAD Densitometry Trend Composition Composition Trend AHA Inform 4 A Composition Reference Estimated Total Body Tissue CF Sie LK nA ie 35 i KI 25 15 KE 10 2 20 30 40 50 60 70 DI 50 100 Age years World Health Organization BMI Classification BMI 24 7 kg m3 13 18 5 25 30 35 DN 101 137 164 191 Weight bs for height 62 0 in Composition Estimated Total Body Estimated Android Estimated Gynoid The Estimated Total Body exam report found in the Report Center for Spine Femur exams includes a reference graph trend graph when applicable BMI graph and table that includes Tissue Fat Tissue Lean and Centile are displayed 4 8 6 Estimated Total Body Composition Limitations 68 of estimated total body Fat values will be within a
133. save your changes Refer to Basic Analysis Procedures for additional Lateral Spine Analysis information 4 10 LVA Morphometry Analysis LVA Morphometry features only appear in the enCORE software if you purchased the LVA Morphometry option for your bone densitometer 4 10 1 LVA Morphometry Analysis Tools Morphometry Description Analysis Tool Morphometry Select Morphometry to complete a Morphometry analysis of a LVA measurement Density Select Density if a bone density analysis of a LVA is desired This option is not available if you used SmartScan during measurement aye Morphometry Wizard Select this tool to start the Morphometry Wizard The KZ Morphometry Wizard labels measures and assigns deformities to the vertebrae Change Deformity Select Change Deformity Indication and then click the target Indication ROI to set or change the deformity assessment for a vertebra Only use this tool to override automated morphometry analysis Sg Show Hide ROls Onscreen control to show or hide ROIs Morphometry la reports do not show ROls Delete ROI Click on the Delete tool and then click the target ROI Page 86 of 138 Ge With the Morphometry Wizard enabled Gei the following tools become available after clicking a target ROI Morphometry Description w DT E Move Size ROI Click on the Move Size ROI tool Click and drag ROI or edges as needed 8 EE corner but inside the ROI to rotate the ROI Adjust Vertices Cli
134. select ROIs Select the Rotate ROI tool to rotate an ROI Label ROIs This tool is shown when you select ROIs Select the Label ROIs tool to relabel gt ROls after you have added or deleted an ROI from an image Exclude ROIs The Exclude ROI tool lets you remove ROls from AP spine results Select the Exclude ROI tool and then select the ROIs you want to exclude from analysis Parentheses appear around the ROI labels of excluded ROls Results for individual ROIs are shown even if the ROIs are excluded from analysis Excluded ROls are not included in the results for combinations of vertebrae Show Hide This tool allows you to show hide ScanCheck markers that indicate a possible ScanCheck high density area such as an artifact or osteophyte Markers If necessary select Points from the Analyze toolbar to adjust point typing DO NOT adjust the point typing unless the program made obvious errors If you adjust point typing 2 Select Results to view the new analysis results based on your changes Bone Points Neutral Points Tissue Points 3 Select Save to save your changes or select Close then No if you do not want to save your changes Refer to Basic Analysis Procedure for additional AP Spine Analysis information Page 65 of 138 4 3 APVA Morphometry Analysis 4 3 1 APVA Morphometry analysis procedure Complete the steps below to complete an APVA analysis Select an image file for analysis If necessary select Imaging from
135. ss to the superior neck margin Distance from head center to section of minimum CSMI along neck axis Distance along the neck axis from the center of the femoral head to the neck shaft axis intersection Average diameter of the femoral neck 4 7 Total Body Analysis 4 7 1 Total Body Analysis Procedure Both the bone and soft tissue images are shown when you open a total body image for analysis Changes you make to the cut positions on one image are also made on the other image You can turn off the dual image option in the User Options Image tab Refer to the topic Options for further information on configuring User Options Complete the steps below in the order given to complete a Total Body analysis Select an image file for analysis Select Imaging and adjust the image if necessary Page 73 of 138 4 7 2 Total Body Cuts 1 Head The Head cut is located immediately below the chin 2 Left and right arm Both arm cuts pass through the arm sockets and are as close to the body as possible Ensure the cuts separate the hands and arms from the body 3 Left and right forearm Both forearm cuts are as close to the body as possible and separate the elbows and forearms from the body 4 Left and right spine Both spine cuts are as close to the spine as possible without including the rib cage 5 Left and right pelvis Both pelvis cuts pass through the femoral necks and do not touch the pelvis 6 Pelvis
136. t Measure Technique Analysis Technique Anatomy Issues Femur Alert Measure Technique Analysis Technique z Set ScanCheck view to appear first when analyzing Include ScanCheck indications on report bottom of screen Detect the following problems Correct scan mode used AP Spine alignment reasonably straight Optimal contrast and brightness set ROIs properly defined L1 L4 labeled correctly Tissue region properly defined Bone edges properly defined Results consistent with previous scan Analysis region free of unusual high density bone Free of unusual T Score variation Free of unusual curvature AP Spine Comments Detect the following problems Correct scan mode used Sufficient pelvis and shaft separation Femur shaft reasonably straight Proper femur rotation Optimal contrast and brightness set ROls properly defined Tissue region properly defined Bone edges properly defined Results consistent with previous scan Anatomy Issues Analysis region free of unusual high density bone Page 29 of 138 z Femur Comments Total Body Alert Detect the following problems Measure Correct scan mode used Technique Patient within scan field Analysis Technique Optimal contrast and brightness set ROIs properly defined Patient Height Entered Correctly Patient Weight Entered Correctly Anatomy Issues Analysis region free of unusual high density bone Total Bod
137. t on site and the LUNAR program features purchased with enCORE to utilize the optional output features Note Select the Reports tab from the User Options dialog box to change the default settings for the Report dialog box Refer to the Options topic for further information on configuring reports 5 Select OK to create the results report Page 114 of 138 4 21 2 Configure Report Regions Go to Options Chapter or Tools User Options Reports for information on report regions configuration 4 21 3 DXA Results Report There are four standard sections to a results report 1 Heading and patient information contains the report heading and patient ID types you selected in the User Options the patient s biographical information and the measurement and analysis dates 2 Image and Analysis information contains the image reference graph and results table If you selected the Trending default in the Reports tab in User Options or the Trending option in the Patient Report dialog box a trending graph and trending table also appear in this section 3 Comments Section contains information you entered in the Comments filed of the patient information dialog box 4 Footnotes contains scan information the reference population used for analysis and Age matched criteria Page 115 of 138 4 21 4 Examine Results The Results tabs on the Analyze screen let you review BMD reference trend and composition results To change defaul
138. t one of the three output types Output Type Description Provides patient information e g biographical physician insurance Patient data only Fast but does not include exam data e g T score BMD Patient data and most recent Exam Provides patient information and most recent exam data Generation data Medium of this report may take extra time Patient data and full Exam history Provides patient information and full exam history Generation of this Slow report may take a long time Icon Tool Description i l Sort B Click the Sort By drop down menu to sort by a column included in the report y Select Ascending or Descending Click Add Patient Column button to add patient biographical physician Pi Add Patient Column and or insurance information columns to the report output Click available columns to add to the report and then click OK Click Add BMD Column button to add most recent lowest T score Z score Zz Add BMD Column and site region of lowest T score Z score Click available columns to add to the report and then click OK This button is only available when creating reports with the most recent exam data Page 108 of 138 e Click Add Morph Column button to add the lowest morphometry Z score Wl Add Morph Column Click available columns to add to the report and then click OK This button is only available when creating reports with the most recent exam data Click Add Composition Column button to add mass and Fat col
139. t settings for graphs reference data and results tables refer to the topic Options 1 Reference Graph The reference graph provides a visual representation of the exam results A patient s BMD expressed in grams per centimeter squared is plotted against his or her age The square with a black dot represents the patient Each colored bar below the dark green section represents one Standard Deviation below the Young Adult value The thin line separating the dark green from the light green indicates a T Score of 1 Following across the patients T Score can be determined BMD igm i YA T Score 1 46 IK 1 22 1 10 0 58 0 86 0 74 0 62 20 2 The T Score indicates how many Standard Deviations a patient s BMD is from the Young Adult BMD A negative T Score indicates the patient s BMD is below the mean BMD value of the healthy Young Adult reference population A positive score J indicates the patient s BMD is above the Young Adult average reference value 1 i BMD eem TA T Seore 0 58 The blue bar displays the Age Matched Reference and demonstrates the change in bone density associated with aging The centerline of the blue bar is called a regression line The regression line shows the expected BMD at different ages for a particular measurement site The blue bar represents the expected Age matched BMD 1 standard deviation for a given patient enCore factors in two variables which affect the regr
140. t typing determines the placement of bone edges Page 62 of 138 Select Points from the Analyze toolbar the Point Type window is shown The program automatically determines if a sample is bone tissue neutral air or artifact Bone Verify that the bone is typed as Bone Artifact Foreign material to be excluded in analysis Tissue Tissue point typing is specific to each measurement site Neutral Select the Neutral brush type and verify that a thin border of neutral samples is shown around the bone DO NOT adjust the point typing unless the program has made obvious errors Change the point typing only if the area that needs to be changed is larger than the default cursor size Only change the Bone and Neutral point typing To adjust point typing select a brush type Bone or Neutral and a brush size Click on the image to make your changes If necessary select the Artifact brush to point type an artifact in the image 3 S Select Reset to return the image to its original state Select Undo to correct errors you make while adjusting the point typing Examples of correct bone point typing AP Spine correct bone point typing Femur correct bone point typing Refer to the specific scan type Analysis for further information Page 63 of 138 4 2 AP Spine Analysis Note The results include ScanCheck tab Use ScanCheck to assist in the analysis of the image and to help you make corrections where necessary See the sec
141. ted error Find Errors takes you to similar errors in the list If you cannot correct the error condition go to Tools Send Configuration and check the Error log and Configuration files options Email the files into support Or you can print the Error log by selecting Print Errors Call your GE representative and provide them with the error description as shown in the Errors section 2 0 Quality Assurance 2 0 1 Daily Quality Assurance Procedure Complete a Quality Assurance QA test each morning before you measure a patient If the room temperature changes more the 5 C during the day then perform another Daily QA This procedure calibrates and verifies functionality as well as the accuracy and precision of the densitometer The QA procedure should be performed a minimum of once a week if the scanner is not being used Save all QA printouts Use the black calibration block to complete a QA test the calibration block consists of tissue equivalent material with three bone simulating chambers of known bone mineral content Leave the pad on the scanner table during the QA procedure Select Quality Assurance F5 from the Main screen or select L QA from the Common toolbar 2 D gt boc Start A message instructs the technician to position the calibration block 3 Put the calibration block on the pad so that the laser light 1 rests in the center of the cross hair label on the calibration block Laser Brass on bottom
142. the Analysis tool bar to adjust the image p icon Took Description _ _ ____ _ _ ___ Morphometry Select this tool to start the Morphometry Wizard The w l Wizard Morphometry Wizard helps you label measure and assign deformities to the vertebrae Change Deformity Select Change Deformity Indication to change the Indication deformity assessment for a vertebra e Delete ROI Click on the Delete tool and then click the target ROI 1 Click on the vertebra you want to analyze and select a label for the vertebra The Morphometry Wizard opens 2 Select a deformation for the vertebra When you assign a deformation to a vertebra the symbol for the deformation appears next to the ROI label in the results table in the Analysis window 3 Select Save to save your changes or select Close then No if you do not want to save your changes Refer to Basic Analysis Procedures for additional APVA Analysis information Note If you chose Dual VA the exam includes APVA and LVA measurements Refer to LVA Analysis for more information Image contrast may be inverted Go to Tools User Options Images tab Check the option to Invert Images 4 4 APVA Spine Geometry Analysis APVA Spine Geometry features only appear in the enCORE software if you purchased the APVA Spine Geometry option for your bone densitometer Page 66 of 138 4 4 1 APVA Spine Geometry Analysis Tools a a oaa Analysis Tool edges as needed E of the
143. the necessary modifications specific to their facility and save the style sheet under a different name Refer to the enCORE Composer Training Guide Help Composer for basic information on features and functionality Refer to Composer MultiMedia for detailed instructions 4 Select Save to save the style sheet and enter a name for the style sheet 4 21 DXA Results Report 4 21 1 Creating Results Report 1 Open an Analyzed Exam i K o oi Select Report from the Analysis toolbar The Report Center dialog box is shown E Report Center Des na Gor Printer uars H0 1 4ShPRT 1 i ISS AP Spine Dersibometry ve Trendig DI DusiFemur Densitometry el Trending _ Number of copies EE M Trending Single Region T sow adc ene ee ee 3 Check the box for each report that you want to generate Change the report settings if necessary and check the box to select each device to which you want to send this report such as the printer HL7 etc The Number of Copies field shows how many copies of each report the program will create Check the Individual Page Copies box to set the number of copies for each page of the report Check the Trending option to enable single region trending Click on Set as Default to default to these settings for all reports 4 Check Show Advanced Features to view all output options E mail Fax DICOM and HL report Output options are available The customer must have the appropriate equipmen
144. the program Screens and toolbars give the options necessary to complete the procedures given in this online Operator s Manual 1 1 1 Using screens The screens provide information that lets you set up and complete measurements analysis and quality assurance procedures At the bottom of each screen short descriptions of procedures and alternative keystrokes are given to help you complete a procedure 1 1 2 Using toolbars The toolbars show icons that represent a tool which lets you complete a specific procedure To view a short description of a tool hold the cursor stationary over the tool s icon 1 1 3 Patient block The Patient block is shown at the bottom of the Analyze Directory and New Measurement screens The Patient block gives information about the patient that is being analyzed measured or is currently selected at the Directory screen This is the same information you record in the Patient Information dialog box or select from the Patient list before starting a new measurement Page 14 of 138 1 2 Main Screen The Main screen is the first screen shown during the program Select the options that follow to access different areas of the program Help F1 select to view additional reference information concerning the operation of the scanner Analyze F3 select to open a patient measurement for analysis Quality Assurance F5 select to access the Quality Assurance QA screen Exit F8 select to
145. ther relief to which such party may be entitled This product includes some software components that are licensed under the GNU General Public License GPL Source code for GPL components is available upon request General Product Information The bone densitometer is designed to estimate the bone mineral density of patients when medically indicated by their physicians The manuals provide instructions for operating the software and scan table system information and maintenance information Variables Affecting Scan Results Scan results can be affected by operator technique and patient variability e Operator technique refers to patient positioning and scan analysis To minimize technique variables 1 establish consistent positioning and scan analysis routines by using anatomical landmarks when positioning patients and 2 during analysis manipulate raw scan data only when absolutely necessary e Patient variability refers to changes in the patient s medical history metabolism and diet It also refers to diagnostic procedures that involve radionuclide uptake and medical treatment and the presence of external radiation particularly the use of other radiation generating devices in the vicinity of the system To minimize patient variability 1 thoroughly familiarize yourself with the patient s history and 2 install the scanner in an environment effectively shielded from other sources of external radiation United States Federal Law restricts this
146. tion on ScanCheck for more information 4 2 1 AP Spine analysis procedure enCORE software will place the ROIs correctly most of the time Do not make adjustments to the analysis unless there is an obvious adjustment needed Complete the steps below to complete an AP Spine analysis 1 Select an image file for analysis If necessary select Imaging from the Analysis tool bar to adjust the image If necessary select ROIs from the Analyze toolbar to adjust the ROIs Make sure vertebrae are correctly identified and intervertebral IV markers are between the vertebral bodies 1 and located at the lowest point of bone density as indicated on the bone profile 2 Select Results to view the analysis results Page 64 of 138 Use the tools given if it is necessary to adjust ROIs for an AP Spine image This tool is shown when you select ROIs Select the Add ROI tool to add an ROI during AP Spine analysis When you add a new ROI it is inserted below the ROI L Add ROI that is selected on the image Select the Label ROIs tool to label the ROIs accordingly This tool is shown when you select ROIs Select the Delete ROI tool to remove an ROI during AP Spine analysis use the left mouse button to click on the ROI Delete ROI then select the Delete ROI tool Select the Label ROls tool to relabel the ROls if necessary oan ROI This tool is shown when you select ROIs Select the Move ROI tool to move ROIs Rotate ROI This tool is shown when you
147. to access User Options Connectivity Options and the Error Log 1 7 1 User Options User Options let you set and change the program default settings Select the Tools menu and select User OR Options Select Options F6 from the Main screen and select User Options Change the necessary default setting s Select OK to save changes If you do not want to save changes select Cancel User Options Description Systems This tab lists scanner System ID number and Feature code User Interface Options S Exam File Options and ISCD settings If the Automatic return to Directory option is selected you will return to the Directory screen instead of the main screen when you close windows The Auxiliary Workstation option is shown if you purchased the Multi User Database kit Select this option to prevent the workstation from performing QA procedures or patient measurements The Number of Open Exams option lets you choose how many exams can be opened for analysis at the same time VW Use this option to determine how information is sorted in the Patient and Exam Image lists and to configure default ethnicity You can also choose to expand exams by default Enable Disable analysis features for all scan types You can also choose the type of Small Animal calibration to use and the type of forearm calibration to use for BMD results Ce Display The Results Display tab lets you change the appearance of graphs Standard WHO Ey or JSBMR Y
148. to stop the scanner arm and immediately shut down x rays in an emergency Do not use the emergency stop button to routinely stop the scanner during normal operation Positioning switches The positioning switches move the scanner arm and detector to the measurement start position the laser light indicates the position of the detector The Back Front switch moves the detector across the width of the scanner table The Left Right switch moves the scanner arm down the length of the scanner table Swing arm position sensing switches DPX Duo and Bravo models only The swing arm position sensing switches detect the locking status of the swing arm and the swing arm latch The swing arm latch must be locked and the swing arm must be in the locked position over the scan table before a measurement can be performed Release of the swing arm latch during a measurement will abort the scan and the measurement data will be lost Scanner Start button iIDXA model only Once the patient has been positioned the scan may be initiated from the green Start Scan button instead of starting the scan from the enCORE software See scan arm control panel for each model below Indicator Lights Lever to lock unlock Swing Arm Positioning Switches Emergency Stop Button Indicator Lights Emergency Stop Button Positioning Switches DPX Pro NT MD Page 12 of 138 Indicator Lights Emergency Stop Button Positioning Switches LUNAR Start Scan
149. top The Pelvis Top cut is immediately above the top of the pelvis 7 Left and right leg Both leg cuts separate the hands and forearms from the legs 8 Center leg The Center Leg cut separates the right and left leg Adjust Cuts Select the ES ROI tool from the Analysis toolbar D Select the of Move Vertex tool Adjust the cut itself or select a vertex to adjust the cut position Icon Tool Description Move Vertex This tool is shown when you select ROIs Select E the Move Vertex tool if it is necessary to position ROI vertices or cuts Select Results to view the analysis results Select Save to save your changes or select Close then No if you do not want to save your changes 4 7 3 Total Left Total Right Regions The option to generate total left and total right regions is located in Tools User Options Analysis tab Check the option box to enable Left Right Total Body results 4 7 4 Half Body Scan to Estimate Total Body For very wide patients that do not fit within the scan boundaries it is recommended that the analysis of half of the body be done Page 74 of 138 In this example only the entire right half of the body fit into the scan area S Click on the tool to estimate one side of the body from the other 4 8 Composition Analysis Composition results are shown on the screen when you select the Composition tab in the Analyze window e Fatas a percentage total tissue and as a percentage of regi
150. trates the correct patient and laser position for the measurement type The laser is not used for total body measurements Review Measurement Procedure for further information on the appropriate laser starting position Page 21 of 138 1 5 3 New Measurement Toolbar Description Select to move the scanner arm to the Home position This option is shown after you select Position Select Set Up to return to the set up screen and change the settings for the measurement In addition use this option to select a different measurement type and start a new measurement Repeat This option is shown after you complete an exam Select Repeat to reposition the F4 image and repeat the measurement Abort Select to stop the measurement and save continue resume or start a new F5 measurement Start This option is shown after you select Position Select Start to start the F7 measurement Position Select to move the scanner arm to the start position then use the controls on the F7 scanner arm to position the laser light for the measurement Select to exit the New Measurement screen F8 1 5 4 Home scanner arm Select Home Scanner Cirl H from the Measure menu to move the scanner arm to the home position from any screen in the program A Note If the scan arm has been set to Home at the foot end of the table and the foam leg block is used for AP Spine measurement a warning will appear Please remove patient positioner 1 5
151. tre 5 0 Database Maintenance 5 9 Database Maintenance Compress Database Delete Database Edit Database New Database Archive Rebuild Restore Database Importing Databases MoveScan 5 10 Copy Exam File 5 11 Change Image Type 5 12 Delete Patient and Delete Image 5 13 Edit Patient and Edit Image 5 14 External USB Hard Drive Page 124 of 138 5 15 SQL Database Interface 5 16 Task Scheduler 5 17 Batch Exam File Operations 5 1 Maintenance Procedures Complete database maintenance procedures at the Directory screen select Directory from the Main screen or from the Common toolbar Options to complete database maintenance procedures are given in the Database sidebar refer to Screens and Toolbars for a description of screens and toolbars The Database sidebar includes the following database maintenance tools Edit Database New Database Rebuild Database and Compress Database Follow the links for each of the tools to learn their functionality lt lt More AII Databases Patients MR Composition Study Patients a Rebuild Database ERIE C D atab Bee LOMmpless alabase Note The database maintenance tools are not displayed by default Select the More gt gt button if you are unable to view the database maintenance tools 5 2 Compress Database Select Compress Database from Database side bar to remove excess records that are left in the database when you delete patient records For perform
152. tted in any form or by any means mechanical photocopying recording or otherwise without the express written permission of GE Medical Systems Lunar GE Medical Systems Lunar makes no warranty of any kind with regard to this material and shall not be held liable for errors contained herein or for incidental or consequential damages in connection with the furnishings or use of this manual Read this manual thoroughly before using the system or attempting to service any components Unauthorized service may void system warranties or service contracts Consult GE Medical Systems Lunar Support before attempting any service 800 437 1171 LUNAR is a registered trademark of GE Medical Systems Lunar All other product and brand names are registered trademarks or trademarks of their respective companies Copyright 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 GE Medical Systems Lunar Madison Wisconsin All rights reserved Software License Agreement and Limited Software Warranty Please carefully read the following terms and conditions before installing or operating the GE Medical Systems Lunar Software Software By installing or using the Software in your GE Medical Systems Lunar product You indicate your acceptance of these terms and conditions If You do not agree with the terms and conditions do not install or operate the Software and return it to GE Medical Systems Lunar The Software has been provided to You for use on a sp
153. ues Note This requires the additional step of confirming the heights are set properly for L2 L4 Page 87 of 138 Morphometry Reference Options Morphometry Analysis Technique Z Scores Percent Reduction Cutoffs mild h Moderate Iw Severe Morphometry Reference Options Morphometry Analysis Technique C 2 Scores Percent Reduction 4 W Stature Adjustment Cutoffs Mild sai I Moderate 25 di IW Severe Lan D C Cutoffs determine what deformity will be labeled as Mild Moderate or Severe Adjust if necessary 4 10 3 LVA Imaging A Select the imaging tool to adjust the image The ClearView bar enhances the bone edges of the vertebrae To invert the contrast of your images go to Tools User Options Images tab Check the option to Invert Images Page 88 of 138 4 10 4 LVA Morphometry Analysis Steps Select desired analysis type under Tools User Options Analyze tab and select the Morphometry options Morphometry Options e Create ROIs on Request Recommended C Automatically create Reference ROIs when needed l l C Automatically create ROIs for T8 L4 when opening exam l l l a 1 Enable Morphometry Wizard 4 then follow the steps for the analysis type selected Create ROIs on Request Recommended a Click on a vertebra that appears deformed as close to the center of the vertebra as possible b The Morphometry Wizard window will open Verify the ROI la
154. umns E Add Composition Click available columns to add to the report and then click OK This button is Column only available when creating reports with the most recent exam data Click Configure Exam History button to add Densitometry BMD BMC Area T score and Z score Composition Bone Fat and Lean Mass and 2 Configure Exam Morphometry Anterior Middle Posterior and Average Heights sites regions e History Click the box next to the sites and regions to select Click the plus symbol to expand the sites to display the available regions This button is only available when creating reports with the full exam history K Delete Column Click to highlight the column to delete and then click the Delete button The list can be printed or exported to a text file 2 E HCFA Forms option generates a list of all patients meeting your query criteria The list can be printed directly to your HCFA insurance forms or exported to a text file 3 Mail Merge option can be used to generate form letters or envelopes for mailing lists Save the file with a unique name in mmf format Once mailing lists are created and saved they can be recalled from the Select Form button A Chart option has the ability to show summary displayed as a Pie Chart The chart can be based on a wide selection of options such as treatment lowest value technician attendant or referring physician Output the information to a file or printer Ch
155. vides a standardized bone density report using data from the densitometer and physician generated assessments based on the patient s demographics which can assist the physician in communicating scan results to the patient and the patient s referring physician Optional Hand BMD software estimates the BMD at the hand Optional Dual Energy Vertebral Assessment software provides an x ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights morphometry Optional Orthopedic Hip Software estimates Periprosthetic BMD of an orthopedic hip implant Optional Pediatric software option expands the range of bone densitometry reference data to include ages 5 through 19 years of age The software provides a comparison of measure variables obtained by dual energy x ray absorptiometry to a database of reference values These data can be used for comparative purposes at the sole discretion of the physician Optional Body Composition software measures the regional and whole body bone mineral density BMD lean and fat tissue mass and calculates other derivative values which can be displayed in user defined statistical formats and trends and compared to reference populations at the sole discretion of the health care professional Some of the diseases conditions for which body composition values are useful include chronic renal failure anorexia nervosa obesity AIDS HIV and cystic fibrosis
156. y Comments Forearm Alert Detect the following problems Measure Technique Analysis Technique Forearm alignment reasonably straight Optimal contrast and brightness set ROls properly defined Tissue region properly defined Bone edges properly defined Anatomy Issues Analysis region free of unusual high density bone Forearm Comments 10 Report Tab Function Choices Report Patient ID Types Report Colors DXA Report Configuration Report Center Defaults Report Regions Patient Name Patient ID Facility ID Dept ID Exam ID Attendant Referring Physician Reading Physician or blank Change the background color of DXA Reports Selected Region Only Trend Multiple Results Only Invert Image Show GE Healthcare Logo Show Report Dialog sBMD Footnote on Show Comments Show Vertebral Height T Score Show Ethnicity Opens the Report Center Window for configuration See Report Center Chapter for more information Select the regions desired for each scan type Selected Region will report the region currently highlighted on screen Page 30 of 138 Report Regions for Trending User Information Morphometry Report Options Function Image Storage Format Chart Storage Format Object Storage Format Quality and Resolution for JPG amp PNG Spelling Options PDF Export Security Settings Display ICD9 codes with Fractures Indications and Treatments 12 QA Tab Function
157. y individuals trained by GE Lunar should service or install the X ray Bone Densitometer Do not attempt to service the X ray Bone Densitometer Please call GE service or your GE distributor for support Before operating X ray Bone Densitometer please review the Safety and Technical Specification manual X ray Bone Densitometer Table Assembly Below Scanner is equal to X ray Bone Densitometer Scanner Table The Scanner table is to support the patient during a measurement or general examination In addition the X ray source assembly and other electronics are contained inside the scanner table Scan Arm The laser light emitted from an aperture on the scanner arm helps you locate the measurement start position Positioning switches let you move the scanner arm until the laser light is located at the correct start position The start position is different for each measurement type The scanner arm on the DPX Duo and Bravo models has a release and locking mechanism allowing the upper arm to swivel when the scanner is idle The scanner arm must be in the locked position over the scanner table to perform a measurement Scan arm control panel Indicator Lights Symbol Indicator ss Status on db Power is supplied to the scanner table Yellow x ray X ray tube assembly is supplying x rays Yellow shutter Shutter is open Amber laser Laser is on Page 11 of 138 Emergency stop button Push the red emergency stop button
158. you received with your system Now follow the measurement procedure for the site you selected 3 2 3 AP Spine measurement The positioning requirements for an AP Spine measurement depend on whether you have chosen to use the foam leg block positioner in the User Options Measure tab The foam block must not be used if OneScan is checked for a specific measurement but it must be used if OneScan is not checked for the measurement For OneScan measurements the T Score calculation assumes the foam block is not used 1 Foam Leg Block If you are using the foam leg block positioner Help the patient onto the scanner table and position the patient as follows in the center of the scan table Use the centerline on the table as a reference to align the patient The patient s arms should be on the scanner table alongside the patient s body A Warning Remove the foam leg block prior to positioning the scan arm and immediately after the AP Spine scan E Page 39 of 138 Select Position from the New Measurement toolbar The scanner arm moves to the approximate start_position A graphic is shown that gives the correct patient position and measurement start position If you are using the foam leg block Use the support block to elevate the patient s legs Make sure the patient s thighs form a 60 to 90 angle with the table top This step helps separate vertebrae and flatten the lower back 2 OneScan OneScan

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