Horizon User Guide Rev 012 Jan 2020

Horizon

®

Bone Densitometry System

User Guide Part Number: MAN-04871 Revision 012 January 2020

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Customer Support Toll Free in USA: +1.800.321.4659 Email: [email protected] In Europe, South America, or Asia, contact your local dealer or distributor.

© 2020 Hologic, Inc. Printed in the USA. This manual was originally written in English. Hologic, Advanced Body Composition, APEX, Horizon, QDR, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the U.S. and/or other countries. Any other product and company names mentioned herein are the trademarks of their respective owners. This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patents.

Horizon Bone Densitometry System User Guide Table of Contents

Table of Contents 1 Overview ...1 1.1 Indications for Use ... 1 1.1.1 APEX Indications ... 1 1.1.2 IVA Indications ... 1 1.1.3 Body Composition Indications ... 1 1.1.4 Visceral Fat Software ... 2 1.1.5 10-year Fracture Risk Indications ... 2 1.1.6 Hip Structure Analysis Indications ... 3 1.1.7 Single Energy (SE) Femur Exam Indications ... 3 1.2 Contraindications ... 3 1.3 IEC Regulations ... 3 1.4 Warnings and Cautions ... 3 1.4.1 EMI... 4 1.4.2 Accessories ... 4 1.4.3 Caution ... 4 1.5 Labels ... 4 1.6 Symbols... 7 1.7 Support Materials ... 8 1.7.1 QDR Reference Manual... 8 1.7.2 Online Help... 8 1.7.3 QDR Series Technical Specifications Manual ... 8 1.7.4 QDR Cyber-Security Information... 8 1.8 Main Window ... 8 1.8.1 Main Window Features... 8

2 System Startup and Shutdown...9 2.1 System Startup ... 9 2.2 System Shutdown... 9

3 Quality Control Procedure ...10 3.1 System Test... 10 3.2 Auto QC ... 10 3.3 Automatic Body Composition Calibration ... 11

4 Patient Records ...11 4.1 Retrieving a Patient Record ... 11 4.2 Creating a Patient Record... 11 4.3 Editing a Patient Record... 12 4.4 Using Worklist to Retrieve a Patient Record ... 12

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4.5 Confirming Patient Information... 12 4.5.1 Biographical Information... 12 4.5.2 Exam Information ... 12

5 Performing an Exam ...13 5.1 Patient Interview ... 13 5.2 Patient Preparation... 13 5.3 Patient Selection... 14 5.4 Choosing the Scan Type ... 14 5.5 Performing a Scan... 14

6 Manual Scan Analysis...14 6.1 Analysis Step Buttons ... 14 6.2 Toolboxes ... 16 6.2.1 Bone Map Toolbox ... 16 6.2.2 Lines Toolbox (Spine)... 17 6.2.3 Neck Toolbox (Hip) ... 17 6.2.4 Results Toolbox (Whole Body)... 17 6.2.5 Sub Region Toolbox... 17 6.2.6 Toolbox Controls... 18 6.3 Brightness/Contrast Control ... 19

7 AP Lumbar Spine Examination...19 7.1 Positioning the Patient... 19 7.2 Positioning the C-arm ... 20 7.3 Starting the AP Lumbar Spine Scan... 21 7.3.1 Repositioning the Scan (if necessary)... 21 7.4 Analyzing the Scan... 22 7.4.1 One-Time™ Auto Analysis ... 23 7.5 Exiting Analysis ... 23 7.6 Generating and Printing Reports ... 23

8 Hip Examination ...24 8.1 Positioning the Patient for Left, Right and Dual Hip Examinations... 24 8.2 Positioning the C-arm ... 25 8.2.1 Tips to Identify the Greater Trochanter... 25 8.2.2 Left Hip or Right Hip without Autopositioning for Hip Scans ... 26 8.2.3 Left Hip or Right Hip with Autopositioning for Hip Scans ... 26 8.2.4 Dual-Hip... 27 8.3 Starting the Hip Scan ... 28 8.3.1 Repositioning the scan ... 28 8.3.2 Repositioning the patient... 29

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8.3.3 Additional Steps for the Dual-Hip Scan ... 29 8.4 Analyzing the Scan... 29 8.4.1 One-Time Auto Analysis ... 29 8.5 SE (Single Energy) Femur Examination ... 30 8.5.1 Positioning for the SE Femur scan... 31 8.5.2 Positioning for the SE Femur Scan after a Hip Scan ... 32 8.5.3 Starting the SE Femur Scan ... 32 8.5.4 Analysis of SE Femur Scan ... 32 8.5.5 Visual Assessment ... 33 8.5.6 Image Toolbox ... 33 8.5.7 Analysis Tools Control Tab ... 33 8.5.8 Assessment... 34 8.6 References ... 36 8.6.1 Dual-Hip Scans... 37 8.7 Generating and Printing Reports ... 37

9 Forearm Examination ...37 9.1 Measuring the Patientʹs Forearm ... 37 9.2 Positioning the Patient... 37 9.2.1 Positioning the Patient for Supine Forearm Examinations... 39 9.3 Positioning the C-arm ... 41 9.4 Starting the Forearm Scan ... 41 9.4.1 Repositioning the Scan (if necessary)... 42 9.4.2 Repositioning the Patient (if necessary) ... 42 9.5 Analyzing the Scan... 43 9.5.1 Entering the Forearm Length ... 43 9.5.2 Defining the Global ROI ... 43 9.5.3 Viewing the Bone Map... 44 9.5.4 Checking the MID/UD Region ... 44 9.6 Viewing Results ... 45 9.7 Exiting Analysis ... 45 9.8 Generating and Printing Reports ... 45

10 Whole Body Examination...46 10.1 Body Composition Analysis ... 46 10.2 Positioning the Patient... 46 10.3 Starting the Whole Body Scan ... 47 10.4 Whole Body Fan Beam Analysis ... 47 10.5 Analyzing the Scan... 48 10.5.1 Body Composition Analysis... 48

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10.5.2 Default Placement of Whole Body Regions ... 48 10.5.3 Adjusting A/G Regions (if necessary) ... 51 10.5.4 Visceral Adipose Tissue ... 52 10.5.5 Adjusting VAT Regions (if necessary) ... 53 10.5.6 VAT References ... 55 10.6 Viewing Results ... 56 10.6.1 Rulers ... 56 10.7 Exiting Analysis ... 57 10.8 User-Defined SubRegions ... 57 10.9 Resolving Asymmetric Results with Reflection... 57 10.10 Enable NHANES BCA ... 59 10.11 Generating and Printing Reports ... 59

11 Supine AP/Lateral Spine BMD Examination (Horizon A) ...60 11.1 Table Safety Feature ... 60 11.2 Positioning for the AP/Lateral Scan... 60 11.3 Starting the AP Scan... 61 11.4 Analyzing the AP Scan ... 61 11.5 Starting the Lateral Scan... 61 11.6 Analyzing the Lateral Scan ... 62 11.6.1 Defining the Global ROI ... 62 11.6.2 Adjusting the Vertebral Boundaries... 63 11.6.3 Adjusting the Vertebral Bodies... 64 11.6.4 Viewing the Bone Map... 64 11.6.5 Adjusting the Mid Regions... 65 11.7 Viewing Results ... 65 11.8 Exiting Analysis ... 65 11.9 Generating and Printing Reports ... 65

12 Decubitus Lateral Spine BMD Examination ...66 12.1 Performing and Analyzing the AP Scan ... 66 12.2 Positioning the Patient for the Decubitus Lateral Scan... 66 12.3 Positioning the C-arm for the Decubitus Lateral Scan... 67 12.4 Starting the Decubitus Lateral Scan... 67 12.4.1 Repositioning the Scan (if necessary)... 68 12.5 Analyzing the Scan... 69 12.5.1 Defining the Global ROI ... 69 12.5.2 Adjusting the Vertebral Boundaries... 69 12.5.3 Adjusting the Vertebral Bodies... 70 12.5.4 Viewing the Bone Map... 71

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12.6 Viewing Results ... 71 12.7 Exiting Analysis ... 71 12.8 Generating and Printing Reports ... 71

13 IVA, IVA HD Imaging on Horizon C, W; IVA Imaging on Horizon Ci, Wi ...72 13.1 Choosing the Scan Type ... 72 13.2 Positioning the Patient for the AP IVA Scan ... 72 13.3 Starting the AP IVA Scan ... 73 13.4 Positioning the Patient and C-arm for the Lateral IVA Scan ... 73 13.5 Starting the Lateral IVA Scan ... 74 13.6 IVA Analysis for Lateral IVA Scan ... 75

14 IVA and IVA HD Imaging on a Horizon A System...75 14.1 Positioning the Patient... 75 14.2 Choosing the Scan Type ... 75 14.3 Starting the AP IVA Scan ... 76 14.4 Starting the Lateral IVA Scan ... 77 14.5 IVA Analysis for Lateral IVA Scan ... 77

15 IVA with BMD Examination ...78 15.1 Positioning the Patient... 78 15.2 Choosing the Scan Type ... 78 15.3 Perform the AP IVA Scan... 78 15.4 Perform and Analyze the AP BMD Scan ... 79 15.5 Perform the Lateral BMD Scan ... 79 15.6 Perform the Lateral IVA Scan ... 79 15.7 IVA Analysis ... 79

16 IVA Analysis...79 16.1 Viewer Window, Left Panel ... 80 16.2 Viewer Window, Middle Panel ... 80 16.3 Viewer Window, Right Panel ... 80 16.4 Viewer Window, Left Panel, Visual Tools Tab ... 81 16.5 Viewer Window, Left Panel Analysis Tools Tab ... 81 16.6 Image Controls... 83 16.7 DE Scan ... 84

17 Interpreting the IVA Image ...84 18 Markers ...86 18.1 Using Markers... 87 18.1.1 Flipping the Image... 87

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18.1.2 Adding Markers ... 87 18.1.3 Selecting Markers... 87 18.2 Result Block ... 88 18.2.1 Result Block for Lateral IVA Scans... 88 18.2.2 Result Block for AP IVA Scans... 89 18.3 Printing... 90 18.3.1 Print Report... 90 18.3.2 Print Image... 90

19 Compare and Follow-up ...91 19.1 Restore a Baseline or Prior Scan ... 91 19.2 Evaluate the Baseline or Prior Scan ... 91 19.3 Perform the Follow-Up Scan... 91 19.4 Analyze the Follow-up Scan Using Compare Analysis... 91 19.5 Use the Legacy Image Style Option ... 92 19.6 Generate the Rate of Change Report ... 92

20 Reports ...92 20.1 Report Information Blocks ... 93 20.2 Edit Comments ... 94 20.3 Rate of Change Report ... 94 20.3.1 Remove Asterisks (*) and Pound Signs (#) from Reports ... 94 20.3.2 Create Hip Pairs for Dual Hip Rate of Change Reports... 95 20.4 Body Composition Reports ... 95 20.4.1 BCA Results ... 95 20.4.2 BCA Rate of Change Results ... 97 20.4.3 Body Composition Reports and Reference Database Comparisons ... 98 20.5 Pediatric Reports ... 99 20.6 DICOM Report... 100 20.6.1 Enter the Accession Number and User Defined Entries ... 101 20.6.2 Preview a DICOM Report... 101 20.6.3 Print a DICOM Report ... 101 20.6.4 Save a DICOM Report ... 101 20.6.5 Send a DICOM Report ... 101 20.6.6 Sort the Scan List ... 101 20.6.7 View the Queue... 101 20.6.8 Close a DICOM Report ... 102 20.7 DxReport... 102 20.7.1 Create a DxReport... 102

21 Interpreting Results...102

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21.0.1 About FRAX... 104 21.0.2 FRAX Limiting Criteria ... 104 21.0.3 About 10-year Fracture Risk - All Countries ... 105 21.0.4 FRAX Risk Factors ... 106 21.0.5 References ... 107

22 Archive Scans...107 23 Locate Scans ...107 24 Restore Scans ...107 25 Copy Scans ...108 26 Query/Retrieve Scans ...108 27 Perform System Backup...108 28 Clean the System...109 28.1 Clean the QDR and Computer Components... 109 28.2 Clean the Table Pad... 109 28.3 Disinfect the Table Pad ... 109 28.4 Clean Accidental Spills ... 109

29 Emergency Procedures ...110 29.1 Power Failure ... 110 29.1.1 Shutting Down ... 110 29.2 Failure During Operation... 111 29.3 Loss of Power ... 111

30 Dose Area Product Meter ...111 30.1 Turning the DAP Meter On and Off... 111

31 Utilities...112 31.1 System Configuration ... 112 31.2 Usage ... 112 31.3 Database Tools ... 112 31.3.1 Patient Management... 112 31.3.2 Export ... 112 31.3.3 Import ... 112 31.3.4 Reconcile... 112 31.3.5 Patient Callback... 112 31.3.6 Auto Baseline Utility ... 112 31.4 Scan File Look ... 113 31.5 Scan File Plot ... 113 31.6 Emergency Motion ... 113

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31.7 AP Reposition ... 113 31.8 Factory Utilities... 113 31.9 Service Utilities ... 113 31.10 Reference Curve... 113 31.10.1 Editor ... 113 31.10.2 Add Ethnicity ... 113 31.10.3 Restore ... 113 31.11 Rebuild Archive Index... 113 31.12 Install Options... 114

32 Reference Curve ...115 32.1 Starting Reference Curve Editor... 115 32.2 Viewing Reference Curve Data ... 115 32.3 Creating New Reference Curve Records ... 116 32.4 Copying a Reference Curve Record... 118 32.5 Editing Reference Curve Records ... 119 32.6 Deleting Reference Curve Records ... 119 32.7 Adding New Ethnic Groups ... 120 32.8 Restoring Reference Curve Database ... 120

33 DICOM Option ...121 34 Configure DICOM Option...121 34.1 DICOM Configuration Tabs ... 121 34.2 Modality Worklist ... 121 34.2.1 Configuring Modality Worklist ... 122 34.3 Query Parameters... 122 34.4 Auto Query Interval... 123 34.5 Query Retry Parameters ... 124 34.6 Purge Interval... 125 34.7 Input From File ... 125 34.8 Worklist Provider ... 126 34.8.1 Worklist Provider Interface ... 126 34.8.2 Worklist Provider Controls ... 126 34.9 Map Worklist Fields... 128 34.10 DICOM Send Destinations... 129 34.10.1 Add / Edit DICOM Send Destination Dialog... 131 34.10.2 Configure DICOM Send ... 133 34.11 DICOM Storage Commitment Destinations... 133 34.11.1 Configure DICOM Send Destinations ... 134

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34.11.2 Add / Edit Storage Commitment Destination Dialog... 136 34.11.3 Configure Storage Commitment... 136 34.12 DICOM Query/Retrieve Destinations ... 137 34.12.1 Add / Edit DICOM Query/Retrieve Destination Dialog ... 139 34.12.2 Configure Query/Retrieve ... 139 34.13 Host ... 140

35 FRAX FAQs ...141

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Horizon Bone Densitometry System User Guide List of Figures

List of Figures Figure 1: Horizon Main Window ... 7 Figure 2: Spine Phantom Position... 9 Figure 3: AP Lumbar Spine Positioning ... 19 Figure 4: Leg Position ... 19 Figure 5: AP Lumbar Spine ... 20 Figure 6: Spine Repositioning ... 21 Figure 7: AP Lumbar Spine Analysis ... 22 Figure 8: Left Hip Positioning without Hip Autopositioning... 23 Figure 9: Right Hip Positioning without Hip Autopositioning ... 24 Figure 10: Foot Positioning (Dual Hip)... 24 Figure 11: Left Hip Positioning with Hip Autopositioning... 26 Figure 12: Hip Repositioning ... 27 Figure 13: Properly Analyzed Hip Scan ... 29 Figure 14: Left SE Femur Positioning... 30 Figure 15: Measuring the Left Forearm ... 36 Figure 16: Left Forearm Positioning... 37 Figure 17: Laser Position on Left Arm ... 37 Figure 18: Right Forearm Positioning ... 38 Figure 19: Laser Position on Right Arm ... 38 Figure 20: Patient On/Off Position for Left Supine Forearm ... 39 Figure 21: Patient Position for Left Supine Forearm... 39 Figure 22: Patient Position for Right Supine Forearm ... 40 Figure 23: Forearm Repositioning ... 41 Figure 24: Forearm ROI... 42 Figure 25: Forearm Bone Map... 43 Figure 26: Forearm MID/UD ... 44 Figure 27: Whole Body Positioning ... 46 Figure 28: Whole Body Analysis (Horizontal and Lower Pelvic Divider Lines)... 48 Figure 29: Whole Body Analysis (Vertical Lines)... 49 Figure 30: A/G Regions ... 51

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Horizon Bone Densitometry System User Guide List of Figures

Figure 31: VAT Regions Pictured as CT Slice ... 52 Figure 32: Abdominal Tissue Features ... 53 Figure 33: VAT Regions ... 54 Figure 34: Asymmetric Results Warning... 57 Figure 35: AP/Lateral Spine Positioning... 60 Figure 36: Lateral Spine... 61 Figure 37: Lateral ROI ... 62 Figure 38: Vertebral Boundaries ... 62 Figure 39: Vertebral Bodies... 63 Figure 40: Lateral Bone Map ... 64 Figure 41: Decubitus Lateral Positioning ... 65 Figure 42: Spine Position ... 66 Figure 43: Decubitus Spine ... 67 Figure 44: Decubitus Repositioning ... 67 Figure 45: Lateral ROI ... 68 Figure 46: Vertebral Boundaries ... 69 Figure 47: Vertebral Bodies... 69 Figure 48: Lateral Bone Map ... 70 Figure 49: AP IVA Positioning ... 72 Figure 50: Lateral IVA Positioning ... 73 Figure 51: Spine Position ... 73 Figure 52: AP IVA Positioning ... 74 Figure 53: Lateral IVA Positioning ... 76 Figure 54: IVA Viewer Window ... 78 Figure 55: The Human Spine... 84 Figure 56: Vertebrae Deformities... 85 Figure 57: Marker Placement... 85 Figure 58: Adding a Marker ... 86 Figure 59: Selecting a Marker ... 87 Figure 60: Marker Data in the Result Block ... 87 Figure 61: Result Block ... 88 Figure 62: Report Blocks ... 92

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Horizon Bone Densitometry System User Guide List of Figures

Figure 63: Advanced Body Composition Report ... 94 Figure 64: Advanced Body Composition Rate of Change Report ... 95 Figure 65: Pediatric Spine Report ... 98 Figure 66: Create and Send a DICOM Report... 98 Figure 67: Circuit Breaker and Indicator ... 108

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Horizon Bone Densitometry System User Guide List of Tables

List of Tables Table 1: Symbols ...7 Table 2: Analysis Step Buttons ...14 Table 3: Global ROI Toolbox ...16 Table 4: Bone Map Toolbox ...16 Table 5: Neck Toolbox (Hip) ...17 Table 6: Neck Toolbox (Hip) ...17 Table 7: Sub Region Toolbox ...17 Table 8: Toolbox Controls ...18 Table 9: Image Toolbox ...33 Table 10: Assessment ...34 Table 11: Adding and Modifying Rulers ...34 Table 12: Display Options ...35 Table 13: Change Annotations ...35 Table 14: Atypical Femoral Fracture Assessment ...36 Table 15: Ulnar Styloid Process ...43 Table 16: Viewer Window, Left Panel ...80 Table 17: Viewer Window, Middle Panel ...80 Table 18: Viewer Window, Right Panel ...80 Table 19: Viewer Window, Left Panel, Visual Tools Tab ...81 Table 20: Assessment Area ...81 Table 21: Display Options Area ...82 Table 22: Change Annotations Area ...82 Table 23: Image Controls ...83 Table 24: Result Block Labels ...89 Table 25: Result Block for the AP IVA Scan ...90 Table 26: Follow-up Scan Procedures ...91 Table 27: Advanced Body Composition Report Fields ...96 Table 28: Advanced Body Composition Graph Fields ...96 Table 29: Advanced Body Composition Rate of Change Report Fields ...97 Table 30: Advanced Body Composition Rate of Change Graph Fields ...98

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Horizon Bone Densitometry System User Guide List of Tables

Table 31: FRAX Risk Factors ...106 Table 32: Reference Curve Description Fields ...117 Table 33: Query Parameters ...123 Table 34: Auto Query Interval ...124 Table 35: Query Retry Parameters ...124 Table 36: Purge Interval ...125 Table 37: Input From File ...126 Table 38: Worklist Provider Features ...126 Table 39: Worklist Provider ...127 Table 40: Performed Procedure Step ...127 Table 41: Provider ...127 Table 42: DICOM Send Destinations ...129 Table 43: DICOM Send Destinations ...131 Table 44: DICOM Send Configuration ...133 Table 45: DICOM Storage Commitment Destinations ...134 Table 46: Storage Commitment Destination Editing ...136 Table 47: Storage Commitment Configuration ...136 Table 48: DICOM Query/Retrieve Destinations ...137 Table 49: Add / Edit DICOM Query/Retrieve Destination ...139 Table 50: Query/Retrieve Configuration ...139 Table 51: Host Configuration ...140

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Horizon Bone Densitometry System User Guide 1. Overview

1 Overview 1.1

Indications for Use

1.1.1

APEX Indications The APEX™ for QDR™ X-ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR X-ray Bone Densitometers.

1.1.2

IVA Indications IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.

1.1.3

Body Composition Indications The Hologic Whole Body DXA Reference Database software used on Hologic QDR bone densitometers measures the: • regional and whole body bone mineral density, • lean and fat tissue mass, and • calculates derivative values of: •bone mineral content •% fat, regional •area

•% fat, total body

•soft tissue mass

•% fat, android

•regional soft tissue mass

•% fat, gynoid

•total soft tissue mass

•% fat, android/gynoid ratio

•fat free mass

•body mass index

•regional and total soft tissue mass ratios The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.

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