SELENIA Dimensions User Guide Rev 003 April 2016

a

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User Guide For Software Version 1.8 with C-View

Part Number MAN-04197 Revision 003 April 2016

Selenia Dimensions System User Guide Table of Contents

Table of Contents List of Figures _________________________________________________________________ xi List of Tables _________________________________________________________________ xv 1: Introduction __________________________________________________________________1 1.1 1.2 1.3 1.4 1.5 1.6 1.7

1.8 1.9 1.10 1.11 1.12 1.13 1.14

1.15 1.16 1.17 1.18 1.19

Intended Use... 1 Potential Adverse Effects of Mammography Systems on Health ... 1 Contraindications... 2 Intended Use for the User Guide ... 2 System Capabilities... 2 More Information About Tomosynthesis ... 2 About C-View... 4 1.7.1 C-View Software ... 4 1.7.2 Warnings ... 4 1.7.3 C-View Theory of Operation ... 4 Product Complaints ... 5 Technical Support ... 5 Warranty Statement ... 5 Hologic Cybersecurity Statement ... 6 Quality Control Requirements ... 6 Where to Find the Installation Instructions ... 6 User Profiles... 6 1.14.1 Mammography Technologist ... 6 1.14.2 Radiologist ... 6 1.14.3 Medical Physicist ... 6 Training Requirements... 7 Terms and Definitions ... 7 Symbols ... 8 Descriptions of Warnings, Cautions, and Notes ... 10 Document Conventions ... 10

2: General Information__________________________________________________________11 2.1

2.2 2.3 2.4 2.5 2.6

2.7

System Description ... 11 2.1.1 Tubestand ... 11 2.1.2 Acquisition Workstation ... 12 Safety Information ... 13 Warnings and Precautions... 13 Emergency Off Switches ... 17 Interlocks ... 17 Compliance ... 18 2.6.1 Compliance Requirements ... 18 2.6.2 Compliance Statements ... 19 Label Locations ... 21

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3: System Controls and Indicators ________________________________________________25 3.1 3.2

3.3

3.4

3.5 3.6

3.7 3.8 3.9

System Power Controls ... 25 Acquisition Workstation Controls and Indicators... 26 3.2.1 Universal Acquisition Workstation Controls and Displays ... 26 3.2.2 Premium Acquisition Workstation Controls and Displays ... 27 3.2.3 Standard Acquisition Workstation Controls and Displays ... 28 3.2.4 Keyboard ... 29 3.2.5 Bar Code Scanner ... 29 3.2.6 Universal Acquisition Workstation Display ... 29 3.2.7 Premium Acquisition Workstation Touchscreen Display ... 29 3.2.8 Standard Acquisition Workstation Display ... 29 3.2.9 Preview Display ... 29 Tubestand Controls and Indicators ... 30 3.3.1 C-Arm Controls ... 31 3.3.2 Compression Device Controls and Displays ... 31 3.3.3 Tubehead Display ... 32 3.3.4 Dual Function Footswitches ... 32 How to Turn On the Selenia Dimensions System ... 33 3.4.1 Preparation... 33 3.4.2 Startup ... 33 3.4.3 Log In ... 35 How to Change the Language... 36 Perform the Functional Tests... 36 3.6.1 Compression Functional Tests ... 37 3.6.2 C-Arm Movement Functional Tests ... 38 Emergency Off Switches Functionality ... 44 How to Turn Off the System ... 45 How to Remove All Power from the Acquisition Workstation ... 45

4: The User Interface ____________________________________________________________47 4.1 4.2 4.3 4.4

Select the Function to Perform ... 47 About the Taskbar... 48 How to Perform the Quality Control Tasks ... 51 The Select Patient Screen ... 52 4.4.1 About the Notices Tab ... 53 4.4.2 How to Open a Patient ... 53 4.4.2.1 How to Add a New Patient ... 54 4.4.3 How to Edit the Patient Information ... 54 4.4.4 How to Delete a Patient Manually... 54 4.4.5 The Patient Filter Screen ... 55 4.4.6 How to Refresh the Worklist ... 56 4.4.7 How to Query the Worklist ... 56 4.4.8 About the Admin Button ... 57 4.4.9 How to Log Out ... 57 4.4.10 Advanced Workflow Manager... 57

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4.5

4.6 4.7 4.8

4.9

The Procedure Screen ... 57 4.5.1 How to Set the Exposure Parameters ... 58 4.5.2 How to Use the Implant Present Button ... 59 4.5.3 How to Use the Paddle Shift Feature ... 59 4.5.4 How to Acquire an Image... 60 4.5.5 How to Add or Remove a View ... 62 4.5.6 Procedure Information Dialog Box... 63 4.5.7 How to Add a Procedure ... 64 4.5.8 How to Edit a View ... 65 4.5.9 How to Close a Procedure ... 66 How to Access Image Review Features ... 66 How to Use I-View 2D Contrast ... 67 4.7.1 How to Define Contrast Settings ... 70 How to Use the Output Groups... 72 4.8.1 How to Select an Output Group ... 72 4.8.2 How to Add or Edit an Output Group ... 72 4.8.3 How to Use the Custom Output ... 73 How to Use the On-Demand Outputs ... 73 4.9.1 How to Archive ... 73 4.9.2 How to Export ... 74 4.9.3 How to Print ... 75

5: The Images __________________________________________________________________77 5.1

5.2

5.3

Introduction ... 77 5.1.1 Conventional Imaging Sequence of Events ... 78 5.1.2 Tomosynthesis Imaging Sequence of Events (Tomosynthesis Option)... 78 5.1.3 About Auto-Hanging and Auto-Pairing ... 79 How to Review the Images ... 80 5.2.1 The Image Review Tools Tab ... 81 5.2.2 The Notices Tab... 82 5.2.3 Other Image Review Tools ... 83 5.2.4 Slice Indicator ... 84 5.2.5 How to Correct and Reprocess Implant Images ... 84 Send the Images to the Output Devices ... 85

6: How to Use the Accessories ___________________________________________________87 6.1 6.2 6.3

6.4

Introduction ... 87 How to Install Accessories on the C-Arm ... 87 The Patient Face Shields... 88 6.3.1 How to Install or Remove the Retractable Face Shield ... 88 6.3.2 How to Use the Retractable Face Shield ... 89 6.3.3 How to Install or Remove the Conventional Face Shield ... 90 Compression Paddles ... 91 6.4.1 Routine Screening Paddles ... 92 6.4.2 Contact and Spot Compression Paddles... 92

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6.5 6.6

6.4.3 Magnification Paddles ... 92 6.4.4 Localization Paddles ... 93 6.4.5 Large Ultrasound Paddle ... 93 6.4.6 How to Install or Remove a Compression Paddle ... 94 6.4.7 Maintenance and Cleaning ... 94 6.4.8 Paddle Shift ... 95 6.4.9 FAST Compression Mode ... 95 Magnification Stand... 96 6.5.1 How to Install and Remove the Magnification Stand ... 96 Crosshair Devices... 97 6.6.1 How to Install and Remove the Localization Crosshair Device ... 97 6.6.2 How to Use the Localization Crosshair Device ... 98 6.6.3 How to Install and Remove the Magnification Crosshair Device ... 99 6.6.4 How to Align the Crosshair Device ... 100

7: Clinical Procedures __________________________________________________________101 7.1

7.2

7.3

Standard Workflow ... 101 7.1.1 Preparation... 101 7.1.2 At the Gantry ... 101 7.1.3 At the Acquisition Workstation ... 102 Screening Procedure Example... 102 7.2.1 How to Position the Patient ... 103 7.2.2 Set the Exposure Techniques ... 103 7.2.3 How to Acquire the Exposure ... 103 7.2.4 How to Automatically Store the Image ... 105 7.2.5 How to Accept a Rejected Image ... 105 7.2.6 How to Accept or Reject a Pended Image ... 105 Procedure for Needle Localization with Tomosynthesis ... 106

8: Maintenance and Cleaning ___________________________________________________109 8.1

8.2

Cleaning ... 109 8.1.1 General Information About Cleaning ... 109 8.1.2 For General Cleaning ... 109 8.1.3 To Prevent Possible Injury or Equipment Damage ... 110 8.1.4 Acquisition Workstation ... 111 Maintenance... 112 8.2.1 Preventive Maintenance Schedule ... 112 8.2.2 About Reclamation ... 112

9: System Administration Interface ______________________________________________113 9.1 9.2 9.3

9.4

How to Use the Admin Screen ... 113 The About Screen ... 115 How to Use the System Tools... 116 9.3.1 The System Tools for the Radiologic Technologist Manager ... 117 9.3.2 Remote Access to Image Reports ... 118 How to Use the Archive Tool ... 120

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Appendix A Specifications _____________________________________________________123 A.1

A.2

A.3 A.4

A.5

A.6

Product Measurements ... 123 A.1.1 Tubestand (Gantry with C-Arm) ... 123 A.1.2 Acquisition Workstations ... 124 Operation and Storage Environment ... 128 A.2.1 General Conditions for Operation ... 128 A.2.2 Storage Environment ... 128 Radiation Shield ... 129 Electrical Input ... 129 A.4.1 Tubestand ... 129 A.4.2 Acquisition Workstation ... 129 Tubestand Technical Information... 129 A.5.1 C-Arm ... 129 A.5.2 Compression ... 130 A.5.3 X-ray Tube ... 131 A.5.4 X-ray Beam Filtration and Output ... 131 A.5.5 X-ray Collimation... 132 A.5.6 Light Field Indication ... 132 A.5.7 X-ray Generator ... 132 Imaging System Technical Information ... 133 A.6.1 Image Receptor... 133

Appendix B The System Messages and Alert Messages ____________________________135 B.1 B.2

B.3

Error Recovery and Troubleshooting... 135 Types of Messages ... 135 B.2.1 Fault Levels ... 135 B.2.2 System Messages ... 135 UPS Operation ... 138

Appendix C Dimensions Mobile ________________________________________________139 C.1 C.2 C.3

C.4

C.5 C.6 C.7 C.8

General Information ... 139 Conditions for Safety and Other Precautions ... 139 Mobile Specifications ... 140 C.3.1 Shock and Vibration Limits ... 140 C.3.2 Coach Environment ... 140 Electrical Input ... 140 C.4.1 Gantry ... 140 C.4.2 Acquisition Workstation ... 141 Prepare the System for Travel ... 141 Prepare the System for Use... 143 Test the System after Travel ... 144 C.7.1 Selenia Dimensions Controls and Functional Tests ... 144 Quality Control Tests ... 144

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Appendix D Dose Information _________________________________________________145 D.1

EUREF Dose Tables ... 145

Index ________________________________________________________________________147

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List of Figures Figure 1: Selenia® Dimensions® System Tubestand ... 11 Figure 2: Acquisition Workstation ... 12 Figure 3: Label Locations ... 21 Figure 4: System Power Controls ... 25 Figure 5: Universal Acquisition Workstation Controls and Displays ... 26 Figure 6: Premium Acquisition Workstation Controls and Displays ... 27 Figure 7: Standard Acquisition Workstation Controls and Displays ... 28 Figure 8: Tubestand Controls and Indicators ... 30 Figure 9: C-arm Controls ... 31 Figure 10: Compression Device ... 31 Figure 11: Compression Display... 31 Figure 12: Tubehead Display ... 32 Figure 13: Dual Function Footswitches ... 32 Figure 14: Reset the Emergency Off Switches ... 33 Figure 15: Universal Acquisition Workstation Power Buttons ... 33 Figure 16: Premium Acquisition Workstation Power Buttons ... 33 Figure 17: Standard Acquisition Workstation Power Buttons ... 33 Figure 18: Startup Screen ... 34 Figure 19: Log In Screen... 35 Figure 20: C-arm Controls (left side shown) ... 36 Figure 21: Emergency Off Switch Functionality ... 44 Figure 22: Universal Acquisition Workstation Power Buttons ... 45 Figure 23: Premium Acquisition Workstation Power Buttons ... 45 Figure 24: Standard Acquisition Workstation Power Buttons ... 45 Figure 25: An Example Select Function to Perform Screen ... 47 Figure 26: The Taskbar ... 48 Figure 27: An Example Quality Control Screen ... 51 Figure 28: The Select Patient Screen ... 52 Figure 29: The Enterprise Tab ... 52 Figure 30: How to Add a New Patient ... 54 Figure 31: The Filter Tab in the Patient Filter Screen ... 55 Figure 32: The Generator Tab in an Example Procedure Screen ... 57 Figure 33: Paddle Shift Buttons... 59 Figure 34: Exposure In Progress ... 60 Figure 35: Exposure Complete ... 61 Figure 36: The Add View Screen ... 62 Figure 37: The Procedure Info Window ... 63 Figure 38: Add Procedure Dialog Box ... 64 Figure 39: The Edit View Screen ... 65 Figure 40: I-View 2D Contrast Screen ... 67 Figure 41: I-View 2D Contrast Screen, Waiting Period ... 68 Figure 42: I-View 2D Contrast Screen, Optimal Imaging Period ... 69

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Figure 43: I-View 2D Contrast Settings ... 70 Figure 44: I-View 2D Contrast Settings, Admin screen ... 71 Figure 45: Output Groups Field ... 72 Figure 46: An Example Custom Output Group ... 73 Figure 47: Select the Images for Export... 74 Figure 48: Export Screen ... 74 Figure 49: The Print Screen ... 76 Figure 50: The Preview Screen ... 77 Figure 51: Enable Auto-Hanging and Auto-Pairing ... 79 Figure 52: The Tools Tab (Tomosynthesis option shown)... 80 Figure 53: Marked Images in a Procedure (Tomosynthesis option shown) ... 80 Figure 54: Image Review Tools ... 81 Figure 55: The Notices Tools Tab... 82 Figure 56: Exposure Index ... 83 Figure 57: Display Modes ... 83 Figure 58: Slice Indicator... 84 Figure 59: C-arm Accessories ... 87 Figure 60: How to Align the Retractable Face Shield on the C-arm ... 88 Figure 61: Face Shield Installation ... 89 Figure 62: Face Shield Operation ... 89 Figure 63: How to Install the Conventional Face Shield ... 90 Figure 64: How to Install a Compression Paddle ... 94 Figure 65: How to Remove the Compression Paddle ... 94 Figure 66: The FAST Compression Mode Slide ... 95 Figure 67: Installation of the Magnification Stand ... 96 Figure 68: How to Attach the Localization Crosshair Device ... 97 Figure 69: How to Install and Remove the Magnification Crosshair Device... 99 Figure 70: Screening Example ... 102 Figure 71: Exposure In Progress ... 104 Figure 72: Exposure Complete ... 104 Figure 73: Calculating needle depth... 107 Figure 74: The Admin Screen ... 113 Figure 75: About (the Acquisition Workstation) Screen with the System Tab Showing ... 115 Figure 76: The System Tools Screen ... 117 Figure 77: Remote Logon Screen for Service Tools ... 118 Figure 78: Service Tools Welcome Screen... 119 Figure 79: Create Image Report Parameters ... 119 Figure 80: Create Image Report ... 120 Figure 81: Archive Button ... 120 Figure 82: Multi Patient On Demand Archive Screen... 121 Figure 83: Export Screen ... 122 Figure 84: Tubestand (Gantry with C-arm) Dimensions ... 123 Figure 85: Universal Acquisition Workstation Dimensions system ... 124 Figure 86: Premium Acquisition Workstation Dimensions system ... 125 Figure 87: Standard Acquisition Workstation Dimensions system ... 126

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Figure 88: Mobile Universal Acquisition Workstation Dimensions system ... 127 Figure 89: Mobile (non-Universal) Acquisition Workstation Dimensions system ... 128 Figure 90: UPS LCD Display ... 138 Figure 91: Keyboard Tray Lock Knob ... 141 Figure 92: Keyboard Tray Lock Knob ... 141 Figure 93: Tray Lock Release from Locked (A) to Unlocked (D) ... 141 Figure 94: Swivel Lock Knobs for Preview Display on Mobile Universal Acquisition Workstation ... 142 Figure 95: Tray Lock Release from Locked (A) to Unlocked (D) ... 143 Figure 96: Swivel Lock Knobs for Preview Display on Mobile Universal Acquisition Workstation ... 143

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List of Tables Table 1: List of Labels ... 22 Table 2: Compression Tests ... 37 Table 3: C-arm Up and Down Movement ... 38 Table 4: C-arm Counterclockwise Rotation... 40 Table 5: C-arm Clockwise Rotation ... 40 Table 6: C-arm Rotation Switch ... 41 Table 7: Automatic C-arm Counterclockwise Rotation ... 42 Table 8: Automatic C-arm Clockwise Rotation ... 43 Table 9: Automatic C-arm Movement to Zero Position ... 43 Table 10: C-arm Collimation ... 43 Table 11: Shifting Paddle ... 44 Table 12: Taskbar Menus ... 48 Table 13: The Select Patient Screen ... 52 Table 14: The Filter Tab Options (Require Access Privileges) ... 56 Table 15: Procedure Groups ... 64 Table 16: Available Accessories ... 91 Table 17: User Preventive Maintenance... 112 Table 18: Admin Screen Functions ... 114 Table 19: Radiologic Technologist Manager-System Tools Functions ... 117 Table 20: Maximum mA Setting as a Function of kV ... 131 Table 21: System Messages ... 136 Table 22: 2D Dose (EUREF) ... 145 Table 23: BT Dose (EUREF) ... 145 Table 24: CEDM Dose (EUREF) ... 145

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Selenia Dimensions System User Guide Chapter 1: Introduction

Chapter 1 Introduction 1:

Caution: Federal law restricts this device to sale by or on the order of a physician.

1.1

Intended Use The Hologic® Selenia® Dimensions® system generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions (2D or 3D) system is intended for use in the same clinical applications as a 2D mammography system for screening mammograms. Specifically, the Selenia Dimensions system can be used to generate 2D digital mammograms and 3D mammograms. Each screening examination may consist of:

•

a 2D FFDM image set - OR -

•

a 2D and 3D image set, where the 2D image can be either an FFDM or a 2D image generated from the 3D image set

The Selenia Dimensions system may also be used for additional diagnostic workup of the breast. Note In Canada and Singapore, Tomosynthesis is not approved for screening, and must be used in conjunction with a 2D image (either a FFDM image or 2D image generated from the 3D image set). Contrast Enhanced Digital Mammography Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion.

1.2

Potential Adverse Effects of Mammography Systems on Health Below is a list of the potential adverse effects (such as complications) associated with the use of the device (these risks are the same as for other screen-film or digital mammography systems):

• •

Excessive breast compression

• • •

Electric shock

Excessive x-ray exposure Infection Skin irritation, abrasions, or puncture wounds

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1.3

Contraindications There are no known contraindications.

1.4

Intended Use for the User Guide Always refer to the User Guide for instructions on using the system.

1.5

System Capabilities The system provides the user interfaces for the performance of screening and diagnostic mammograms:

1.6

•

Conventional mammography with a digital image receptor equivalent in size to large mammography film.

•

Tomosynthesis scan with a digital image receptor equivalent in size to large mammography film (Tomosynthesis option).

•

Conventional digital mammogram and tomosynthesis scan during one compression (Tomosynthesis option).

More Information About Tomosynthesis The Hologic Selenia Dimensions system received FDA approval for the Hologic Tomosynthesis option on 11 Feb 2011 (refer to PMA number P080003). This FDA approval applies to screening and diagnostic imaging. More information is available from the FDA website at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearan ces/Recently-ApprovedDevices/ucm246400.htm. The Generated 2D option (C-View™) in conjunction with Tomosynthesis received FDA approval on 16 May 2013 (refer to PMA number P080003 S001). More information is available from the FDA website at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/ recently-approveddevices/ucm353734.htm. A list of scientific publications about Breast Tomosynthesis is available from the Hologic website. The majority of the studies were done with the commercially released Hologic Selenia Dimensions Tomosynthesis system. See the publication at http://www.hologic.com/sites/default/files/Tomo-Bibliography-Rev-13.pdf. The Hologic website has several white papers and summary cards about breast imaging publications. See the documents at http://www.hologic.com/en/learning-center/whitepapers/breastimaging/. Independent publications have examined Hologic Selenia Dimensions Tomosynthesis systems in population-based screening sequences in Europe. Results consistently show a significant increase in invasive cancer detection rate at the same time as a reduction in false positives. The following publications are recommended.

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Integration of 3D digital mammography with tomosynthesis for population breastcancer screening (STORM): a prospective comparison study. Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fantò C, Valentini M, Montemezzi S, Macaskill P. Lancet Oncol. 2013 Jun;14(7):583-9. doi: 10.1016/S1470-2045(13)70134-7. Epub 2013 Apr 25.

http://www.ncbi.nlm.nih.gov/pubmed/23623721 Prospective trial comparing full-field digital mammography (FFDM) versus combined FFDM and tomosynthesis in a population-based screening programme using independent double reading with arbitration. Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Hofvind S. Eur Radiol. 2013 Aug;23(8):2061-71. doi: 10.1007/s00330-013-2820-3. Epub 2013 Apr 4.

http://www.ncbi.nlm.nih.gov/pubmed/23553585 Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.

http://www.ncbi.nlm.nih.gov/pubmed/23297332 Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Skaane P, Bandos AI, Eben EB, Jebsen IN, Krager M, Haakenaasen U, Ekseth U, Izadi M, Hofvind S, Gullien R. Radiology. 2014 Jun;271(3):655-63. doi: 10.1148/radiol.13131391. Epub 2014 Jan 24

http://www.ncbi.nlm.nih.gov/pubmed/24484063 Breast Cancer Screening Using Tomosynthesis in Combination With Digital Mammography Sarah M. Friedewald, MD1; Elizabeth A. Rafferty, MD2; Stephen L. Rose, MD3,4; Melissa A. Durand, MD5; Donna M. Plecha, MD6; Julianne S. Greenberg, MD7; Mary K. Hayes, MD8; Debra S. Copit, MD9; Kara L. Carlson, MD10; Thomas M. Cink, MD11; Lora D. Barke, DO12; Linda N. Greer, MD13; Dave P. Miller, MS14; Emily F. Conant, MD15 JAMA. 2014;311(24):2499-2507. doi:10.1001/jama.2014.6095

http://jama.jamanetwork.com/article.aspx?articleid=1883018 IMPORTANT: Hologic strongly recommends that users make themselves familiar with local or regional regulations. These regulations could impose restrictions on the different types of clinical use. Because the regulations could evolve and change over time, periodic review is recommended.

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1.7

About C-View

1.7.1

C-View Software The C-View™ software uses image data available from a breast tomosynthesis acquisition to generate one digital mammogram (2D) per breast tomosynthesis acquisition. The C-View 2D image is created without the need for an additional digital mammography exposure. The C-View 2D image is designed to appear similar to, and serve the same purpose as, a digital mammogram (2D) when used as part of a screening study employing tomosynthesis. The C-View 2D image is interpreted in combination with a breast tomosynthesis image set and is not intended to be used without the accompanying breast tomosynthesis images to make a clinical decision or diagnosis.

1.7.2

Warnings Warning: Do not make a clinical decision or diagnosis from the C-View 2D images without reviewing the accompanying tomosynthesis image set. Use the C-View 2D images in the same way you would use conventional digital mammography (2D) when performing a screening study employing tomosynthesis.

•

While reviewing the C-View 2D images for items or areas of interest, compare to a prior digital mammogram (2D) if priors exist and then review the related tomosynthesis images carefully.

•

Carefully examine the entire tomosynthesis image set before making a clinical decision.

Warning: The appearance of a C-View 2D image may differ from that of a conventional digital mammography (2D) image, just as 2D film and digital mammography (2D) images from different vendors may look different. Users should ensure they are adequately trained and are familiar with the appearance of C-View 2D images before using them in conjunction with tomosynthesis image sets.

1.7.3

C-View Theory of Operation Overview The C-View software is an image processing application for post-processing the pixel data from tomosynthesis data, captured on a Selenia Dimensions tomosynthesis imaging system, into a digital mammography (2D) image. The C-View 2D image can be used in place of a digital mammogram (2D) as part of a screening study employing tomosynthesis. The C-View software processes tomosynthesis data to generate 2D images which are designed to appear similar to and serve the same purpose as a digital mammogram (2D) when used as part of a screening study employing tomosynthesis.

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Configuration The C-View software has no user-configurable settings that influence the appearance of the resulting C-View 2D images. C-View 2D images are produced in either DICOM Breast Tomosynthesis Image object format, as a single thick slice, or DICOM Digital Mammography Image object format. The site PACS administrator, in consultation with Hologic connectivity engineers, can select the output format most appropriate for the site’s IT infrastructure and workstations. Each C-View 2D image DICOM header contains the information needed to differentiate it from any accompanying conventional 2D image(s) or tomosynthesis image sets in the same view. An annotation (“C-View”) will also be burned to the C-View 2D image pixel data. Workflow As with any imaging study, the technologist selects the patient and identifies the type of imaging procedure that will be done. For an exam with C-View 2D images, the process of imaging the subject and completing the study is all that is necessary. The C-View software itself operates with no direct human intervention.

1.8

Product Complaints Report any complaints or problems in the quality, reliability, safety, or performance of this product to Hologic. If the device has caused or added to patient injury, immediately report the incident to Hologic. (See the title page for contact information.)

1.9

Technical Support Refer to the title page of this manual for contact information for product support.

1.10

Warranty Statement Except as otherwise expressly stated in the Agreement: i) Equipment manufactured by Hologic is warranted to the original Customer to perform substantially in accordance with published product specifications for one (1) year starting from the date of shipment, or if Installation is required, from the date of Installation (“Warranty Period”); ii) digital imaging mammography x-ray tubes are warranted for twenty-four (24) months, during which the x-ray tubes are fully warranted for the first twelve (12) months and are warranted on a straight-line prorated basis during months 13-24; iii) replacement parts and remanufactured items are warranted for the remainder of the Warranty Period or ninety (90) days from shipment, whichever is longer; iv) consumable Supplies are warranted to conform to published specifications for a period ending on the expiration date shown on their respective packages; v) licensed Software is warranted to operate in accordance with published specifications; vi) Services are warranted to be supplied in a workman-like manner; vii) non-Hologic Manufactured Equipment is warranted through its manufacturer and such manufacturer’s warranties shall extend to Hologic’s customers, to the extent permitted by the manufacturer of such non-Hologic Manufactured Equipment. Hologic does not warrant that use of Products will be uninterrupted or error-free, or that Products will operate with non-Hologic authorized third-party products.

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1.11

Hologic Cybersecurity Statement Hologic continuously tests the current state of computer and network security to examine possible security problems. When necessary, Hologic provides the updates to the product. For Cybersecurity Best Practices documents for Hologic products, refer to the Hologic Internet site.

1.12

Quality Control Requirements The facilities in the United States must use the Quality Control Manual to create a Quality Assurance and Quality Control program. The facility must create the program to meet the requirements of the Mammography Quality Standards Act or to be accredited by ACR or another accreditation body. The facilities outside the United States can use the Quality Control Manual as a guide to create a program to meet the local standards and regulations.

1.13

Where to Find the Installation Instructions Installation instructions are available in the Service Manual.

1.14

User Profiles

1.14.1 Mammography Technologist •

Meets all requirements that apply to the location in which the Mammography Technologist operates.

• • •

Completed training on the mammography system. Has training in mammography positions. Knows how to operate a computer and its peripherals.

1.14.2 Radiologist •

Meets all requirements that apply to the location in which the Radiologist operates.

•

Knows how to operate a computer and its peripherals.

1.14.3 Medical Physicist

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•

Meets all requirements that apply to the location in which the Medical Physicist operates.

• • •

Knows about mammography. Has experience with digital imaging. Knows how to operate a computer and its peripherals.

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1.15

Training Requirements In the United States, users must be Registered Radiologic Technologists meeting criteria to perform mammography. The mammography users must meet all applicable MQSA personnel requirements under FDA guidelines for conventional and digital mammography. The user has options available for training, which include but are not limited to:

•

Onsite applications training by a Hologic Clinical Services Specialist

•

Onsite on the job training also known as peer training

Additionally, the user manual is a guide for directions on how to use the system. All users must make sure that they receive training on correct operation of the system before use on patients. Hologic does not accept the responsibility for injury or damage from wrong system operation.

1.16

Terms and Definitions

ACR AEC Annotations BT C-View™

CEDM CE2D Collimator Combo Mode

Conventional Mammography Diagnostic Workstation DICOM DM EMC FAST Paddle™ Gantry

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American College of Radiology Automatic Exposure Control Graphic or text marks on an image to indicate an area of interest (Breast Tomosynthesis) An imaging procedure that provides information about the breast in three dimensions A licensed Hologic feature where a digital mammogram (DM) image is generated from data acquired during a breast tomosynthesis scan Contrast Enhanced Digital Mammography Hologic term for CEDM Device at the x-ray tube to control the area of the receptor that is exposed Hologic acquisition mode consisting of a traditional digital mammogram (DM) with a breast tomosynthesis (BT) scan under the same compression Single projection x-ray images of views for screening and diagnostic purposes Softcopy workstation for diagnoses from digital images Digital Imaging and Communications in Medicine Digital Mammography (2D) Electromagnetic Compatibility (Fully Automatic Self-Adjusting Tilt) Paddle A part of the Selenia Dimensions system that has the Detector, Generator and X-ray Source, Positioning/Compression, Power Distribution, and Accessories Subsystems

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