Horizon User Guide Rev 02 July 2021

Horizon

®

Bone Densitometry System

User Guide For Windows 10

Part Number MAN-08072-002 Revision 002 July 2021

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

Product Support USA:

+1.800.321.4659

Email:

[email protected]

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

© 2021 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 United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners. This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patent-information.

Horizon Bone Densitometry System User Guide Table of Contents

Table of Contents List of Figures ________________________________________________________________xiii List of Tables _________________________________________________________________ xv 1: Overview_____________________________________________________________________1 1.1

1.2 1.3 1.4

1.5 1.6 1.7

1.8

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 ... 2 1.1.7 Single Energy (SE) Femur Exam Indications ... 3 Contraindications... 3 IEC Regulations ... 3 Warnings and Cautions ... 3 1.4.1 EMI ... 3 1.4.2 Accessories ... 4 1.4.3 Caution ... 4 Labels ... 4 Symbols ... 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 Main Window... 9

2: System Startup and Shutdown _________________________________________________11 2.1 2.2

System Startup ... 11 System Shutdown ... 11

3: Quality Control Procedure ____________________________________________________13 3.1 3.2 3.3

System Test ... 13 Auto QC ... 13 Automatic Body Composition Calibration ... 14

4: Patient Records ______________________________________________________________15 4.1 4.2 4.3 4.4

Retrieving a Patient Record ... 15 Creating a Patient Record ... 15 Editing a Patient Record ... 15 Using Worklist to Retrieve a Patient Record ... 16

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4.5

Confirming Patient Information ... 16 4.5.1 Biographical Information... 16 4.5.2 Exam Information ... 16

5: Performing an Exam __________________________________________________________17 5.1 5.2 5.3 5.4 5.5

Patient Interview ... 17 Patient Preparation ... 18 Patient Selection ... 18 Choosing the Scan Type ... 18 Performing a Scan ... 18

6: Manual Scan Analysis ________________________________________________________19 6.1 6.2

6.3

Analysis Step Buttons ... 19 Toolboxes ... 21 6.2.1 Bone Map Toolbox ... 21 6.2.2 Lines Toolbox (Spine) ... 21 6.2.3 Neck Toolbox (Hip) ... 22 6.2.4 Results Toolbox (Whole Body)... 22 6.2.5 Sub Region Toolbox... 22 6.2.6 Toolbox Controls ... 23 Brightness/Contrast Control ... 24

7: AP Lumbar Spine Examination ________________________________________________25 7.1 7.2 7.3 7.4 7.5 7.6

Positioning the Patient ... 25 Positioning the C-arm... 26 Starting the AP Lumbar Spine Scan ... 27 7.3.1 Repositioning the Scan (if necessary) ... 28 Analyzing the Scan ... 29 7.4.1 One-Time™ Auto Analysis ... 29 Exiting Analysis ... 30 Generating and Printing Reports ... 30

8: Hip Examination _____________________________________________________________31 8.1 8.2

8.3

vi

Positioning the Patient for Left, Right and Dual Hip Examinations ... 31 Positioning the C-arm... 32 8.2.1 Tips to Identify the Greater Trochanter ... 33 8.2.2 Left Hip or Right Hip without Autopositioning for Hip Scans ... 33 8.2.3 Left Hip or Right Hip with Autopositioning for Hip Scans ... 33 8.2.4 Dual-Hip ... 34 Starting the Hip Scan ... 35 8.3.1 Repositioning the scan ... 35 8.3.2 Repositioning the patient ... 36 8.3.3 Additional Steps for the Dual-Hip Scan ... 36

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8.4 8.5

8.6 8.7

Analyzing the Scan ... 36 8.4.1 One-Time Auto Analysis ... 37 SE (Single Energy) Femur Examination ... 38 8.5.1 Positioning for the SE Femur scan ... 38 8.5.2 Positioning for the SE Femur Scan after a Hip Scan ... 39 8.5.3 Starting the SE Femur Scan ... 39 8.5.4 Analysis of SE Femur Scan ... 40 8.5.5 Visual Assessment ... 40 8.5.6 Image Toolbox... 41 8.5.7 Analysis Tools Control Tab ... 41 8.5.8 Assessment ... 42 References ... 45 8.6.1 Dual-Hip Scans ... 45 Generating and Printing Reports ... 45

9: Forearm Examination _________________________________________________________47 9.1 9.2 9.3 9.4

9.5

9.6 9.7 9.8

Measuring the Patient's Forearm ... 47 Positioning the Patient ... 47 9.2.1 Positioning the Patient for Supine Forearm Examinations ... 50 Positioning the C-arm ... 51 Starting the Forearm Scan ... 52 9.4.1 Repositioning the Scan (if necessary)... 52 9.4.2 Repositioning the Patient (if necessary) ... 53 Analyzing the Scan ... 53 9.5.1 Entering the Forearm Length ... 53 9.5.2 Defining the Global ROI ... 54 9.5.3 Viewing the Bone Map... 55 9.5.4 Checking the MID/UD Region ... 56 Viewing Results ... 56 Exiting Analysis ... 56 Generating and Printing Reports ... 56

10: Whole Body Examination ____________________________________________________57 10.1 10.2 10.3 10.4 10.5

Body Composition Analysis ... 57 Positioning the Patient ... 57 Starting the Whole Body Scan ... 58 Whole Body Fan Beam Analysis ... 59 Analyzing the Scan ... 59 10.5.1 Body Composition Analysis... 59 10.5.2 Default Placement of Whole Body Regions ... 60 10.5.3 Adjusting A/G Regions (if necessary) ... 62 10.5.4 Visceral Adipose Tissue ... 64 10.5.5 Adjusting VAT Regions (if necessary) ... 65 10.5.6 VAT References... 66

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10.6 Viewing Results... 67 10.6.1 Rulers... 67 10.7 Exiting Analysis ... 68 10.8 User-Defined SubRegions ... 68 10.9 Resolving Asymmetric Results with Reflection ... 69 10.10 Enable NHANES BCA ... 70 10.11 Generating and Printing Reports ... 70

11: Supine AP/Lateral Spine BMD Examination (Horizon A) ________________________71 11.1 11.2 11.3 11.4 11.5 11.6

Table Safety Feature... 71 Positioning for the AP/Lateral Scan ... 71 Starting the AP Scan ... 72 Analyzing the AP Scan ... 72 Starting the Lateral Scan ... 73 Analyzing the Lateral Scan ... 73 11.6.1 Defining the Global ROI ... 74 11.6.2 Adjusting the Vertebral Boundaries... 75 11.6.3 Adjusting the Vertebral Bodies ... 76 11.6.4 Viewing the Bone Map ... 77 11.6.5 Adjusting the Mid Regions... 77 11.7 Viewing Results... 78 11.8 Exiting Analysis ... 78 11.9 Generating and Printing Reports ... 78

12: Decubitus Lateral Spine BMD Examination ____________________________________79 12.1 12.2 12.3 12.4 12.5

12.6 12.7 12.8

Performing and Analyzing the AP Scan ... 79 Positioning the Patient for the Decubitus Lateral Scan ... 79 Positioning the C-arm for the Decubitus Lateral Scan ... 81 Starting the Decubitus Lateral Scan... 81 12.4.1 Repositioning the Scan (if necessary) ... 82 Analyzing the Scan ... 82 12.5.1 Defining the Global ROI ... 83 12.5.2 Adjusting the Vertebral Boundaries... 84 12.5.3 Adjusting the Vertebral Bodies ... 85 12.5.4 Viewing the Bone Map ... 86 Viewing Results... 86 Exiting Analysis ... 86 Generating and Printing Reports ... 86

13: IVA, IVA HD Imaging on Horizon C, W; IVA Imaging on Horizon Ci, Wi _________87 13.1 13.2 13.3 13.4 13.5 13.6

Choosing the Scan Type ... 87 Positioning the Patient for the AP IVA Scan ... 87 Starting the AP IVA Scan ... 88 Positioning the Patient and C-arm for the Lateral IVA Scan ... 89 Starting the Lateral IVA Scan ... 90 IVA Analysis for Lateral IVA Scan ... 90

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14: IVA and IVA HD Imaging on a Horizon A System ______________________________91 14.1 14.2 14.3 14.4 14.5

Positioning the Patient ... 91 Choosing the Scan Type ... 92 Starting the AP IVA Scan ... 92 Starting the Lateral IVA Scan ... 94 IVA Analysis for Lateral IVA Scan ... 94

15: IVA with BMD Examination _________________________________________________95 15.1 15.2 15.3 15.4 15.5 15.6 15.7

Positioning the Patient ... 95 Choosing the Scan Type ... 95 Perform the AP IVA Scan ... 95 Perform and Analyze the AP BMD Scan ... 95 Perform the Lateral BMD Scan... 96 Perform the Lateral IVA Scan ... 96 IVA Analysis... 96

16: IVA Analysis _______________________________________________________________97 16.1 16.2 16.3 16.4 16.5 16.6 16.7

Viewer Window, Left Panel ... 97 Viewer Window, Middle Panel... 98 Viewer Window, Right Panel ... 98 Viewer Window, Left Panel, Visual Tools Tab ... 98 Viewer Window, Left Panel Analysis Tools Tab ... 99 Image Controls ... 100 DE Scan ... 101

17: Interpreting the IVA Image _________________________________________________103 18: Markers ___________________________________________________________________105 18.1 Using Markers ... 105 18.1.1 Flipping the Image ... 105 18.1.2 Adding Markers... 106 18.1.3 Selecting Markers ... 106 18.2 Result Block ... 107 18.2.1 Result Block for Lateral IVA Scans... 107 18.2.2 Result Block for AP IVA Scans ... 109 18.3 Printing ... 109 18.3.1 Print Report ... 109 18.3.2 Print Image ... 109

19: Compare and Follow-up ____________________________________________________111 19.1 19.2 19.3 19.4 19.5

Restore a Baseline or Prior Scan ... 111 Evaluate the Baseline or Prior Scan ... 111 Perform the Follow-Up Scan ... 111 Analyze the Follow-up Scan Using Compare Analysis... 111 Generate the Rate of Change Report ... 112

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20: Reports ___________________________________________________________________113 20.1 Report Information Blocks ... 113 20.2 Edit Comments ... 114 20.3 Rate of Change Report ... 114 20.3.1 Remove Asterisks (*) and Pound Signs (#) from Reports... 114 20.3.2 Create Hip Pairs for Dual Hip Rate of Change Reports ... 115 20.4 Body Composition Reports... 115 20.4.1 BCA Results ... 116 20.4.2 BCA Rate of Change Results ... 117 20.4.3 Body Composition Reports and Reference Database Comparisons ... 118 20.5 Pediatric Reports ... 120 20.6 DICOM Report ... 120 20.6.1 Select a DICOM BMD Report Type ... 120 20.6.2 View Scan Details and Enter Patient Biography Fields ... 121 20.6.3 Enter the Accession Number and User Defined Entries ... 121 20.6.4 Preview a DICOM Report ... 121 20.6.5 Print a DICOM Report ... 121 20.6.6 Save a DICOM Report ... 122 20.6.7 Send a DICOM Report ... 122 20.6.8 Sort the Scan List ... 122 20.6.9 View the Queue... 122 20.6.10 Close a DICOM Report ... 122 20.7 DxReport ... 122 20.7.1 Create a DxReport ... 122

21: Interpreting Results ________________________________________________________123 21.1 About FRAX... 124 21.2 FRAX Limiting Criteria ... 124 21.2.1 Previous hip or vertebral fracture ... 124 21.2.2 Treatment for osteoporosis ... 125 21.2.3 Premenopausal woman ... 125 21.2.4 Configuring FRAX ... 125 21.3 About 10-year Fracture Risk - All Countries ... 125 21.4 FRAX Risk Factors ... 126 21.5 References ... 127

22: Scans _____________________________________________________________________129 22.1 22.2 22.3 22.4 22.5

Archive Scans ... 129 Locate Scans ... 129 Restore Scans ... 129 Copy Scans ... 129 Query/Retrieve Scans ... 130

23: Perform System Backup_____________________________________________________131

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24: Clean the System ___________________________________________________________133 24.1 24.2 24.3 24.4

Clean the QDR and Computer Components ... 133 Clean the Table Pad ... 133 Disinfect the Table Pad ... 133 Clean Accidental Spills ... 134

25: Emergency Procedures ______________________________________________________135 25.1 Power Failure ... 135 25.1.1 Shutting Down ... 135 25.2 Failure During Operation ... 136 25.3 Loss of Power ... 136

26: Dose Area Product Meter ___________________________________________________137 26.1 Turning the DAP Meter On and Off ... 137

27: Utilities ___________________________________________________________________139 27.1 System Configuration... 139 27.2 Usage ... 139 27.3 Database Tools ... 139 27.3.1 Patient Management ... 139 27.3.2 Export ... 139 27.3.3 Import... 139 27.3.4 Reconcile ... 139 27.3.5 Patient Callback ... 139 27.3.6 Auto Baseline Utility ... 139 27.4 Scan File Look... 139 27.5 Scan File Plot... 140 27.6 Emergency Motion ... 140 27.7 AP Reposition ... 140 27.8 Factory Utilities ... 140 27.9 Service Utilities... 140 27.10 Reference Curve ... 140 27.10.1 Editor ... 140 27.10.2 Add Ethnicity ... 140 27.10.3 Restore ... 140 27.11 Rebuild Archive Index ... 140 27.12 Install Options ... 141

28: Reference Curve ___________________________________________________________143 28.1 28.2 28.3 28.4 28.5 28.6

Starting Reference Curve Editor ... 143 Viewing Reference Curve Data ... 144 Creating New Reference Curve Records ... 144 Copying a Reference Curve Record ... 146 Editing Reference Curve Records ... 147 Deleting Reference Curve Records ... 148

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28.7 Adding New Ethnic Groups ... 148 28.8 Restoring Reference Curve Database ... 148

29: DICOM Option ____________________________________________________________149 29.1 Configure DICOM Option ... 149 29.1.1 DICOM Configuration Tabs ... 149 29.1.2 Modality Worklist... 149 29.1.3 Query Parameters ... 150 29.1.4 Auto Query Interval ... 151 29.1.5 Query Retry Parameters ... 152 29.1.6 Purge Interval ... 153 29.1.7 Input From File ... 153 29.1.8 Worklist Provider ... 154 29.1.9 Map Worklist Fields ... 156 29.1.10 DICOM Send Destinations ... 157 29.1.11 DICOM Storage Commitment Destinations ... 162 29.1.12 DICOM Query/Retrieve Destinations ... 166 29.1.13 Host... 169

30: FRAX FAQs _______________________________________________________________171

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List of Figures Figure 1: Horizon Main Window ... 9 Figure 2: Spine Phantom Position ... 13 Figure 3: AP Lumbar Spine Positioning ... 25 Figure 4: Leg Positions ... 26 Figure 5: AP Lumbar Spine ... 27 Figure 6: Spine Repositioning ... 28 Figure 7: AP Lumbar Spine Analysis ... 29 Figure 8: Left Hip Positioning without Hip Autopositioning ... 31 Figure 9: Right Hip Positioning without Hip Autopositioning ... 32 Figure 10: Foot Positioning (Dual Hip) ... 32 Figure 11: Left Hip Positioning with Hip Autopositioning ... 34 Figure 12: Hip Repositioning ... 35 Figure 13: Properly Analyzed Hip Scan ... 37 Figure 14: Left SE Femur Positioning... 38 Figure 15: Measuring the Left Forearm ... 47 Figure 16: Left Forearm Positioning ... 48 Figure 17: Laser Position on Left Arm ... 48 Figure 18: Right Forearm Positioning ... 49 Figure 19: Laser Position on Right Arm ... 49 Figure 20: Patient On/Off Position for Left Supine Forearm ... 50 Figure 21: Patient Position for Left Supine Forearm ... 51 Figure 22: Patient Position for Right Supine Forearm ... 51 Figure 23: Forearm Repositioning ... 52 Figure 24: Forearm ROI... 54 Figure 25: Forearm Bone Map ... 55 Figure 26: Forearm MID/UD ... 56 Figure 27: Whole Body Positioning ... 58 Figure 28: Whole Body Analysis (Horizontal and Lower Pelvic Divider Lines) ... 60 Figure 29: Whole Body Analysis (Vertical Lines) ... 61 Figure 30: A/G Regions ... 63 Figure 31: VAT Regions Pictured as CT Slice ... 64 Figure 32: Abdominal Tissue Features ... 65 Figure 33: VAT Regions ... 66 Figure 34: Asymmetric Results Warning ... 69 Figure 35: AP/Lateral Spine Positioning ... 72 Figure 36: Lateral Spine ... 73 Figure 37: Lateral ROI ... 74 Figure 38: Vertebral Boundaries ... 75 Figure 39: Vertebral Bodies ... 76 Figure 40: Lateral Bone Map ... 77 Figure 41: Decubitus Lateral Positioning ... 80 Figure 42: Spine Position ... 80 MAN-08072-002 Revision 002

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Figure 43: Decubitus Spine ... 81 Figure 44: Decubitus Repositioning ... 82 Figure 45: Lateral ROI ... 83 Figure 46: Adjusting Vertebral Boundaries ... 84 Figure 47: Vertebral Bodies... 85 Figure 48: Lateral Bone Map... 86 Figure 49: AP IVA Positioning ... 88 Figure 50: Lateral IVA Positioning ... 89 Figure 51: Spine Position... 90 Figure 52: AP IVA Positioning ... 91 Figure 53: Lateral IVA Positioning ... 93 Figure 54: IVA Viewer Window ... 97 Figure 55: DE Scan 1 (Top of Region)... 101 Figure 56: DE Scan 2 (Top to Bottom of Region) ... 102 Figure 57: The Human Spine ... 103 Figure 58: Vertebrae Deformities ... 104 Figure 59: Marker Placement... 105 Figure 60: Adding a Marker ... 106 Figure 61: Selecting a Marker ... 106 Figure 62: Marker Data in the Result Block ... 106 Figure 63: Result Block ... 108 Figure 64: Report Blocks ... 113 Figure 65: Advanced Body Composition Report... 116 Figure 66: Advanced Body Composition Rate of Change Report ... 117 Figure 67: Pediatric Spine Report ... 120 Figure 68: Circuit Breaker and Indicator ... 135

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List of Tables Table 1: Symbols ... 7 Table 2: Analysis Step Buttons ... 19 Table 3: Global ROI Toolbox ... 21 Table 4: Bone Map Toolbox ... 21 Table 5: Neck Toolbox (Hip) ... 22 Table 6: Neck Toolbox (Hip) ... 22 Table 7: Sub Region Toolbox ... 22 Table 8: Toolbox Controls ... 23 Table 9: Image Toolbox ... 41 Table 10: Assessment ... 42 Table 11: Adding and Modifying Rulers ... 42 Table 12: Display Options... 43 Table 13: Change Annotations ... 44 Table 14: Atypical Femoral Fracture Assessment ... 44 Table 15: Ulnar Styloid Process... 54 Table 16: Viewer Window, Left Panel ... 97 Table 17: Viewer Window, Middle Panel ... 98 Table 18: Viewer Window, Right Panel ... 98 Table 19: Viewer Window, Left Panel, Visual Tools Tab ... 98 Table 20: Assessment Area ... 99 Table 21: Display Options Area ... 99 Table 22: Change Annotations Area... 100 Table 23: Image Controls ... 100 Table 24: Result Block Labels ... 108 Table 25: Result Block for the AP IVA Scan ... 109 Table 26: Follow-up Scan Procedures ... 111 Table 27: Advanced Body Composition Report Fields ... 116 Table 28: Advanced Body Composition Graph Fields ... 116 Table 29: Advanced Body Composition Rate of Change Report Fields ... 117 Table 30: Advanced Body Composition Rate of Change Graph Fields... 117 Table 31: FRAX Risk Factors ... 126 Table 32: Reference Curve Description Fields ... 145 Table 33: Query Parameters ... 150 Table 34: Auto Query Interval ... 151 Table 35: Query Retry Parameters ... 152 Table 36: Purge Interval ... 153 Table 37: Input From File ... 153 Table 38: Worklist Provider Features ... 154 Table 39: Worklist Provider ... 154 Table 40: Performed Procedure Step ... 155 Table 41: Provider ... 155 Table 42: DICOM Send Destinations... 157 MAN-08072-002 Revision 002

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Table 43: DICOM Send Destinations ... 159 Table 44: DICOM Send Configuration ... 161 Table 45: DICOM Storage Commitment Destinations ... 162 Table 46: Storage Commitment Destination Editing... 164 Table 47: Storage Commitment Configuration ... 165 Table 48: DICOM Query/Retrieve Destinations ... 166 Table 49: Add / Edit DICOM Query/Retrieve Destination... 168 Table 50: Query/Retrieve Configuration... 168 Table 51: Host Configuration ... 169

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Horizon Bone Densitometry System User Guide Chapter 1: Overview

Chapter 1 Overview 1:

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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These body composition values are useful to health care professionals in their management of diseases and conditions where the disease and conditions itself, or its treatment, can affect the relative amounts of fat and lean tissue. The Hologic Whole Body DXA Reference Database software does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases (and conditions) for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis. DXA body composition is a useful alternative to hydrostatic weighting and skin fold measurements.

1.1.4

Visceral Fat Software The Hologic Visceral Fat Software used on Hologic Horizon® bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends. The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/conditions itself, or its treatment, can affect the relative amounts of visceral fat content in the android region. Note The Hologic Visceral Fat Software does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases/conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.

1.1.5

10-year Fracture Risk Indications Femoral neck BMD and clinical risk factors are used to estimate 10-year risk of hip fracture and 10-year risk of major osteoporotic fracture using the World Health Organization (WHO) algorithm (FRAX®) in adults. The physician may use the 10-year fracture risk, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.

1.1.6

Hip Structure Analysis Indications The Hip Structure Analysis (HSA®) for QDR X-ray Bone Densitometers uses data from conventional Dual Energy X-ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

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1.1.7

Single Energy (SE) Femur Exam Indications Single Energy (SE) femur exams are used to visualize focal reaction or thickening along the lateral cortex of the femoral shaft, which may be accompanied by a transverse radiolucent line. Clinical correlation is advised as these features may be consistent with atypical femur fractures, a complication associated with long term use of antiresorptive therapy.

1.2

Contraindications Pregnancy and the use of contrast agents within the past 7 days are contraindicated. See Patient Interview on page 17 for more information.

1.3

IEC Regulations QDR Series X-ray Bone Densitometers comply with the requirements of IEC 60601-1. The classification of the QDR Series X-ray Bone Densitometers under this specification is Class 1, Type B. The QDR Series comply with IEC 60601-1-3 except for Section 29.205.2 which specifies "...focal spot to skin distances (FSSDs) of 45 cm or more in normal use." The QDR Series FSSD, which is approximately 42.5 cm, has been selected to provide optimum spatial resolution and precision with minimum patient exposure. The QDR Series comply with the following IEC standards: IEC 60601-1 2014

IEC 60601-2-28 2010

IEC 60601-1-2 2014

IEC 60825-1 2014

IEC 60601-1-3 2013

IEC 60601-1-6 2013

Software used in the QDR Series was developed using IEC 62304 as a guide.

1.4

Warnings and Cautions Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. No modification of this equipment is allowed.

1.4.1

EMI This instrument is designed to be compatible with the electromagnetic environments specified in IEC60601-1-2 and will operate satisfactorily when placed in an environment that includes other equipment complying with that standard.

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Horizon Bone Densitometry System User Guide Chapter 1: Overview

1.4.2

Accessories Do not use any accessories in conjunction with this instrument other than those supplied by Hologic for use with the instrument.

1.4.3

Caution Caution To protect the integrity of the system and the safety of the patient and operator, do not power the computer and accessories plugged into the outlet strip at the rear of the console from another source. Also, do not power any accessories or appliances other than those provided with the system from the outlet strip at the rear of the console.

1.5

Labels Horizon System Main Label The Main Label includes: •

QDR X-ray Bone Densitometer

•

Horizon Model

•

Manufacturer name and address

•

Complies with FDA Radiation Performance Standards 21 CFR Sub-chapter J applicable on date of manufacture.

•

Date of manufacture

•

Serial Number

•

IEC standards

Laser Exit Aperture Label The Laser Exit Aperture Label includes: •

Avoid Exposure

•

Laser Radiation emitted from this Aperture

INMETRO & ULBR Product Label The INMETRO & ULBR Product Label includes:

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•

includes the INMETRO & ULBR symbols

•

Segurança

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AC Power Label The AC Power Label lists system power specifications including: •

Line Voltage (V)

•

Frequency (Hz)

•

Maximum Current (A)

•

Maximum Apparent Resistance (ohm)

Tank Label The Tank Label includes: •

Manufacturer name and address

•

Model numbers

•

Serial Numbers

•

Nominal tube rating

•

Focal spot

•

Filtration Aluminum equivalence

HF X-ray Source Label The HF X-ray Source Label includes: •

21 CFR Compliance statement

•

Date of manufacture

•

Model number of the source assembly

•

Type: Assembly, source

•

Serial Number of the source assembly

•

IEC standards

Drum Filtration Label The Drum Filtration Label includes:

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•

21 CFR Compliance statement

•

Manufacturer name and address

•

Model assembly number

•

Serial number

•

EC and IEC numbers

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