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3Dimensions System User Guide

Table of Contents

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MAN-05085-002 Revision 002

DRAFT

Preview Copy-Generated May 30, 2018

C.6

Test the System after Travel .............................................................................................................................. 148

C.6.1

Mobile System Controls and Functional Tests ................................................................................. 148

C.7

Quality Control Tests ......................................................................................................................................... 148

Appendix D Dose Information _________________________________________________149

D.1

EUREF Dose Tables ............................................................................................................................................ 149

Glossary of Terms _____________________________________________________________151

Index ________________________________________________________________________153

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Summary of Contents for 3Dimensions

Page 1: ......

Page 2: ......

Page 3: ...3Dimensions Digital Mammography System Digital Tomosynthesis System User Guide For Software Version 2 0 Part Number MAN 05085 002 Revision 002 May 2018...

Page 4: ...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...

Page 5: ...and Intelligent 2D Warnings 5 1 6 3 C View and Intelligent 2D Theory of Operation 6 1 7 User Profiles 6 1 7 1 Mammography Technologist 6 1 7 2 Radiologist 6 1 7 3 Medical Physicist 7 1 8 Training Requ...

Page 6: ...al Tests 34 4 3 3 Collimation 42 4 3 4 Shifting Paddles 43 4 4 Emergency Off Switches Functionality 44 4 5 How to Turn Off the System 44 4 6 How to Remove All Power from the System 44 5 User Interface...

Page 7: ...ing Sequence of Events 72 6 3 3 How to Accept a Rejected Image 73 6 3 4 How to Accept or Reject a Pended Image 73 6 4 How to Correct and Reprocess Implant Images 73 6 4 1 If the Image Is Not Accepted...

Page 8: ...the Gantry 99 8 1 3 At the Acquisition Workstation 100 8 2 Screening Procedure Example 100 8 2 1 Position the Patient 101 8 2 2 Set the Exposure Techniques 101 8 2 3 Acquire the Exposure 101 8 3 Proc...

Page 9: ...ion 133 A 5 Tubestand Technical Information 133 A 5 1 C Arm 133 A 5 2 Compression 134 A 5 3 X ray Tube 135 A 5 4 X ray Beam Filtration and Output 135 A 5 5 X ray Collimation 137 A 5 6 Light Field Indi...

Page 10: ...C 6 1 Mobile System Controls and Functional Tests 148 C 7 Quality Control Tests 148 Appendix D Dose Information _________________________________________________149 D 1 EUREF Dose Tables 149 Glossary...

Page 11: ...tor Log In Screen 31 Figure 18 C arm Control Panel left side shown 32 Figure 19 Emergency Off Switch Functionality 44 Figure 20 Universal Acquisition Workstation Power Buttons 44 Figure 21 An Example...

Page 12: ...Localization Crosshair Device 95 Figure 64 How to Install and Remove the Magnification Crosshair Device 96 Figure 65 Example of a Screening Procedure Screen 100 Figure 66 Exposure In Progress 102 Figu...

Page 13: ...9 Figure 94 Universal Acquisition Workstation Measurements 130 Figure 95 Mobile Universal Acquisition Workstation Measurements 131 Figure 96 UPS LCD Display 142 Figure 97 Keyboard Tray Lock Knob 146 F...

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Page 15: ...MLO Rotation 41 Table 10 C arm Collimation 42 Table 11 Shifting Paddle 43 Table 12 Taskbar Menus 46 Table 13 The Select Patient Screen 48 Table 14 Filter Tab Options Require Access Privileges 54 Tabl...

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Page 17: ...se in the same clinical applications as a 2D mammography system for screening mammograms Specifically the 3Dimensions system can be used to generate 2D digital mammograms and 3D mammograms Each screen...

Page 18: ...ening and diagnostic mammograms Conventional mammography with a digital image receptor equivalent in size to large mammography film Tomosynthesis scan with a digital image receptor equivalent in size...

Page 19: ...te has several white papers and summary cards about breast imaging publications See the documents at http www hologic com en learning center white papers breastimaging Independent publications have ex...

Page 20: ...kenaasen 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 Tom...

Page 21: ...hesis images to make a clinical decision or diagnosis 1 6 2 C View and Intelligent 2D Warnings Warning Do not make a clinical decision or diagnosis from the C View or Intelligent 2D images without rev...

Page 22: ...gital 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...

Page 23: ...o 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 u...

Page 24: ...hall 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 f...

Page 25: ...Equalization terminal Protective Earth terminal OFF power ON power Discard electrical and electronic equipment separately from standard waste Send decommissioned material to Hologic or contact your se...

Page 26: ...procedures that you must follow accurately to prevent possible dangerous or fatal injury Warning The procedures that you must follow accurately to prevent injury Caution The procedures that you must f...

Page 27: ...002 Revision 002 Page 11 DRAFT Preview Copy Generated May 30 2018 2 General Information 2 1 System Overview Figure 1 3Dimensions System Figure Legend 1 Tubestand Gantry and C arm 2 Gantry 3 C arm Tube...

Page 28: ...age 12 MAN 05085 002 Revision 002 DRAFT Preview Copy Generated May 30 2018 2 1 1 C Arm Overview Figure 2 C arm Overview Figure Legend 1 Tube Arm 2 Patient Face Shield 3 Compression Device 4 Image Rece...

Page 29: ...st must remember the health hazards of x rays 2 3 Warnings and Precautions This system is classified as CLASS I TYPE B APPLIED PART IPX0 permanently connected equipment continuous operation with short...

Page 30: ...oltages WARNING The user must correct problems before the system is used Contact an approved service representative for preventive maintenance WARNING After power failure remove the patient from the s...

Page 31: ...nd the radiation shield during the exposure Warning Do not move the C arm while the system retrieves the image Warning If a paddle touches possible infectious materials contact your Infection Control...

Page 32: ...nd not a normal computer Only make approved changes to the hardware or software Install this device behind a firewall for network security The computer virus protection or network security for this me...

Page 33: ...le must meet the following requirements and all local codes that apply 3 conductor 8 AWG 10 mm2 copper not more than 25 feet 7 62 meters in length 2 4 Emergency Off Switches The Emergency Off switches...

Page 34: ...of the manufacturer 2 6 1 Compliance Requirements The manufacturer has the responsibility for the safety reliability and performance of this equipment with the following provisions The electrical inst...

Page 35: ...15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses an...

Page 36: ...tromagnetic compatibility and Radio spectrum Matters ERM ElectroMagnetic Compatibility EMC standard for radio equipment and services FCC 47 CFR Part 15 Subpart C Section 15 225 2009 FDA 21 CFR Parts 8...

Page 37: ...3Dimensions System User Guide Chapter 2 General Information MAN 05085 002 Revision 002 Page 21 DRAFT Preview Copy Generated May 30 2018 2 7 Label Locations Figure 4 Label Locations...

Page 38: ...e 2 Electrical Shock Warning 3 System Model 4 Gantry Nameplate 5 Potential Equalization Terminal 8 Tomographic Mammography Detector 6 Wheelchair Warning for Footswitch 7 Emergency Stop Switch 9 Vendor...

Page 39: ...18 3 System Controls and Indicators 3 1 System Power Controls Figure 5 System Power Controls Figure Legend 1 Gantry Power Circuit Breaker 2 Emergency Off Switch two on the Gantry one on the Acquisitio...

Page 40: ...rated May 30 2018 3 2 Tubestand Controls and Indicators Figure 6 Tubestand Controls and Indicators Figure Legend 1 Rotation Angle Displays each side 2 C arm Control Panels each side 3 Compression Devi...

Page 41: ...play 3 2 2 Compression Device Controls and Display Figure Legend 1 Manual Compression Handwheels 2 Paddle Shift Buttons 3 AEC Sensor Buttons 4 Compression Device Display 5 FAST Compression Mode Slide...

Page 42: ...Legend 1 MLO Rotation 2 C arm Zero 3 Light Field Lamp 4 Motor Enable 5 Collimator Override 6 Clockwise C arm Rotation 7 C arm Up and Down 8 Counterclockwise C arm Rotation 9 Compression Up 10 Compres...

Page 43: ...ch footswitch in a position where when used they remain in reach of the Emergency Off Switches Warning Position the footswitches to prevent accidental operation by a patient or wheelchair To use the f...

Page 44: ...and Displays Figure Legend 1 Height Adjustment Switch 2 Keyboard in drawer 3 Bar Code Scanner 4 Control Monitor 5 Fingerprint Scanner 6 Emergency Off Switch 7 Image Display Monitor 8 X ray Activation...

Page 45: ...o the view of the Operator 2 Make sure that all three Emergency Off switches are in the reset position unpushed Figure 14 Turn to Reset the Emergency Off Switches 3 Make sure that the Gantry circuit b...

Page 46: ...antry then automatically powers on Figure 16 Startup Screen Note The Startup screen includes a Shutdown button that turns off the system and a Reboot button that restarts the system Note The system ca...

Page 47: ...Log In 1 Select the Log In button on the Startup screen 2 The Select an Operator Log In screen opens and shows a list of Manager and Technologist user names If necessary select the Show All button to...

Page 48: ...ion Correct operation Incorrect operation Note If Quality Control tasks are due the Select Function to Perform screen opens You can perform the quality tasks or you can select Skip 4 3 Perform the Fun...

Page 49: ...on Down button x The compression brake engages x The light field lamp illuminates x The compression device lowers Note When you press the Compression Down button the compression brake remains engaged...

Page 50: ...Movement Table 3 C arm Up and Down Movement Function Functional Test C arm Up Press the C arm Up button x C arm movement stops when the button is released x C arm movement stops when the C arm reaches...

Page 51: ...Movement Function Functional Test C arm Down Press the C arm Down button x C arm movement stops when the button is released x C arm movement stops when the C arm reaches the lower travel limit x C ar...

Page 52: ...Counterclockwise Rotation Function Functional Test Counterclockwise C arm Rotation Press the Counterclockwise C arm Rotation button item 1 to start counterclockwise C arm rotation C arm movement stop...

Page 53: ...5 C arm Clockwise Rotation Function Functional Test Clockwise C arm Rotation Press the Clockwise C arm Rotation button item 1 to start clockwise C arm rotation C arm movement stops when the switch is...

Page 54: ...RAFT Preview Copy Generated May 30 2018 Table 6 C arm Rotation Switch Function Functional Test C arm Rotation Switch Push the C arm Rotation switch away from you to move the C arm toward you Pull the...

Page 55: ...Stop switch Motor Enable Press the Motor Enable button and a Rotation button at the same time to enable auto rotation movement clockwise or counterclockwise C arm Zero Press the Motor Enable button an...

Page 56: ...Generated May 30 2018 Table 8 Automatic C arm Clockwise Rotation Function Functional Test Automatic Clockwise C arm Rotation Press the Motor Enable button item 1 and the Clockwise C arm Rotation butt...

Page 57: ...atic MLO Rotation Function Functional Test Automatic Tubehead Rotation to Zero Position Position the C arm at an angle greater than 15 degrees Press the MLO Rotation button item 1 The Tubehead moves a...

Page 58: ...on to show the x ray field then press the Collimator Override button to select an x ray field Light Field Lamp For compression paddles Press the Light Field Lamp button to see the x ray field for two...

Page 59: ...le function Table 11 Shifting Paddle Function Functional Test Paddle Shift The 18 x 24 cm Screening Paddle moves approximately 2 5 cm into the left center or right position While compression is applie...

Page 60: ...ures Refer to Close a Patient on page 62 2 From the Select Patient screen select the Log Out button 3 From the Startup screen select the Shutdown button 4 Select Yes in the confirmation dialog box 4 6...

Page 61: ...tient screen opens when no quality control tasks are scheduled to be done Figure 21 An Example Select Function to Perform Screen To Complete a Scheduled Quality Control Task 1 Select a Quality Control...

Page 62: ...e screen displays additional icons Select the icon to access information or perform system tasks Figure 22 Taskbar Table 12 Taskbar Menus Description Menu 1 Information Icon Select the Information ico...

Page 63: ...ad icon If the Tubehead icon is red with a number next to it the system needs to wait the number of minutes shown before the next image can safely be taken Clear All Faults deletes all fault messages...

Page 64: ...MAN 05085 002 Revision 002 DRAFT Preview Copy Generated May 30 2018 5 3 Select Patient Screen Figure 23 Select Patient Screen Table 13 The Select Patient Screen Item Description 1 Quick Search Search...

Page 65: ...is displayed if you have the Advanced Workflow Manager on page 56 This tab shows the procedures acquired on all compatible networked systems Figure 24 Enterprise Tab 3 Buttons Many functions are acce...

Page 66: ...ith Viewed Notices or patients with Unviewed Notices Select Open to access the Procedure screen for the selected patient 5 3 2 Open a Patient 1 Select a tab to show the desired list of patients 2 Sele...

Page 67: ...it the Patient Records The Split function lets you move images when you acquired the images in the wrong procedure or the wrong patient Note You cannot split images for protected patients Note Archive...

Page 68: ...lect Patient screen select the patient that has the images that need to be moved 2 Select the Split button The Split Patient Records screen opens 3 Select the images to move If all images are being mo...

Page 69: ...to About Reclamation on page 110 1 In the Select Patient screen select one or more patients 2 Select the Delete button 3 When the confirmation prompt is shown select Yes Note The Technologists do not...

Page 70: ...tab allows users with access privileges to add change or delete tabs in the Select Patient screen Refer to the following table Table 14 Filter Tab Options Require Access Privileges Change the current...

Page 71: ...klist Select the Query Worklist button to search the Modality Worklist Provider for a patient or a list of patients There are two methods to enter the query information Keyboard Type the query informa...

Page 72: ...Advanced Workflow Manager keeps track of all patients procedures and images acquired on all systems within an Advanced Workflow Manager cluster In addition the Advanced Workflow Manager synchronizes n...

Page 73: ...t Add View Add a new view Edit View Assign a different view to an image Archive Export Send images to an output Print Print images Retrieve Query the configured devices with the current patient inform...

Page 74: ...ted view The paddle moves to the new position Figure 30 Paddle Shift Buttons 5 4 3 Procedure Information Dialog Box To show procedure information select the Procedure Information button located below...

Page 75: ...nail views for the procedure that was selected Available Procedures The table that follows shows the major groups of procedures that are available on the system Note Some procedures in the list show o...

Page 76: ...placed RL Rolled Lateral RM Rolled Medial RI Rolled Inferior RS Rolled Superior NP Nipple in Profile AC Anterior Compression IMF Infra Mammary Fold AX Axillary Tissue 2 Select the tab then select the...

Page 77: ...he view from the screen You can select a maximum of three View Modifiers See the figure The Add View Screen on page 60 for a description of the View Modifiers 4 Select Save then select OK to the Updat...

Page 78: ...the procedure was discontinued from a list or add a new reason Return To Procedure Returns to the procedure If there are images marked as Pend a dialog box opens with the following options Accept All...

Page 79: ...S Diagnostic Workstations CAD devices and printers from the Output Groups drop down list in the Procedure screen Note Images are not sent if an Output Group is not selected 5 6 2 Add or Edit an Output...

Page 80: ...select OK Figure 36 An Example Custom Output Group 5 7 On Demand Outputs The On Demand Outputs are Archive Export or Print You can manually Archive Export or Print the currently opened patient until t...

Page 81: ...orage Device drop down menu OR Select an output group from the Output Group drop down list 4 Select the Archive button to send the selected images to the selected archive Note Use the Manage Queue uti...

Page 82: ...e 67 to prepare your print data 2 Select the film format from the film format area of the screen 3 Select a thumbnail image 4 Select the image mode Conventional Projection or Reconstruction The C View...

Page 83: ...onstruction views Tomosynthesis option The C View button shows if the system is licensed for C View imaging 9 Select the printer options 10 View Thumbnail images 11 Select the film format number of ti...

Page 84: ......

Page 85: ...r Patient and procedure information can be displayed on the screen To turn the information on or off go to the Tools tab in the Procedure screen and select the Patient Information button Figure 40 Ima...

Page 86: ...lable from 20 49 kV x Manual The user selects the kV mAs Focal Spot and Filter x AEC Auto Time The user selects the kV Focal Spot and Filter The system selects the mAs x AEC Auto kV The user selects t...

Page 87: ...bol and a yellow background see the following figure Figure 41 Exposure In Progress An audible tone continues to sound during the exposure The audible tone is a continuous sequence of tones The tone s...

Page 88: ...ou select Pend a question mark appears on the thumbnail image Figure 43 Marked Images in a Procedure 5 Repeat steps 1 through 4 for each view Note A manager user can configure the system to Auto Accep...

Page 89: ...Auto Pend new images 6 4 How to Correct and Reprocess Implant Images You must correct the image if you acquire an implant or an implant displaced view without the Implant Present button activated 6 4...

Page 90: ...ges involves use of the thumbnails image review tools and display modes Figure 44 Tools Tab Tomosynthesis option shown Figure Legend 1 Image Review Tools refer to Image Review Tools Tab on page 75 2 I...

Page 91: ...ensor areas used for the exposure calculation The sensor areas display on the Image Display screen 9 The Patient Information button activates the patient information display 10 The Auto Hanging button...

Page 92: ...egend 1 The Oval tool draws an oval marking on the image 2 The Ruler tool measures the distance between two points 3 The Freehand tool draws a freehand marking on the image 4 The Text tool adds a text...

Page 93: ...red or yellow area review the selected image for noise and decide whether to reacquire the image Figure 47 Exposure Index Display Modes Use the buttons in the Display Modes area of the screen to selec...

Page 94: ...tagged for printing 2 Up and Down arrows let you change between slices that contain notices 3 H anatomical reference to head direction 4 Slices that contain targets or are tagged for printing 5 Slices...

Page 95: ...ic requirements Your system configuration may not have all the options and accessories included in this manual 1 Select the Contrast tab to access the I ViewTM 2D Contrast CE2D function Figure 50 I Vi...

Page 96: ...nd Note You can adjust the default length of time for the Waiting Period and Optimal Imaging Period phases of the timer Refer to How to Set the Contrast Defaults on page 119 Figure 51 I View 2D Contra...

Page 97: ...ted subtracted image Low Sub Shows both the low and sub screen images side by side in a split screen Caution Using I View 2D Contrast increases the recovery time the machine needs before more images a...

Page 98: ...the Configure Contrast button to edit the contrast settings The Contrast Information dialog box opens Figure 53 I View 2D Contrast Information 2 Use the drop down menus to select the appropriate setti...

Page 99: ...etractable Face Shield Magnification Stand and Localization Crosshairs are installed in slots on the C arm The slots have labels with icons to indicate the accessory that attaches in the slot Each acc...

Page 100: ...all the Retractable Face Shield 1 Completely extend the Face Shield to the outer position 2 Align the hooks of the Face Shield with the mounting slots on the C arm indicated by a face shield icon 3 Pu...

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