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Hologic Selenia Instructions For Use Manual
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Hologic Selenia Instructions For Use Manual

Hologic Selenia Instructions For Use Manual

Digital mammography system
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Summary of Contents for Hologic Selenia

  • Page 3 © Copyright Hologic 2011. All rights reserved. Printed in USA. This manual was originally written in English. Hologic and the Hologic Logo are trademarks or registered trademarks of Hologic, Inc. Other trademarks registered or used by Hologic and its divisions and subsidiaries in the United States and other countries include: Affirm, Dimensions, DSM, FAST Paddle, HTC, MIMS plus, M-IV, MultiCare, SecurView, Selenia, Smart Paddle, StereoLoc, and TechMate.
  • Page 5 4.0 Acquisition Workstation Controls and Display ..................14 4.1 Acquisition Workstation ......................... 14 4.2 Keypads ............................15 4.3 Keyboard and Trackball or Mouse ....................15 4.4 Keyboard and Screen Controls ....................... 16 4.5 Bar Code Scanner .......................... 16 4.6 The Selenia Display ........................17 Part Number MAN-01384...
  • Page 6 4.5 UPS Operation for TechMate ......................31 5.0 How to Log Out ........................... 32 6.0 How to Shut Down the System ......................32 Chapter 4 - The Selenia Accessories 1.0 Introduction ............................33 2.0 Patient Face Shield ..........................34 2.1 How to Install the Face Shield on the Tubehead ................34 2.2 How to Remove the Face Shield ....................
  • Page 7 Instructions for Use Table of Contents 3.0 How to Add a New Patient ........................49 4.0 How to Edit the Existing Patient Data ....................50 4.1 About Patient Information Edits with a Modality Worklist and PACS ..........50 4.2 How to Change the Patient Information After an Image Is Accepted ..........50 5.0 New, Edit, Add a Procedure .........................
  • Page 8 1.1 Tubestand (Gantry with C-arm) ...................... 99 1.2 Acquisition Workstation ........................ 99 1.3 Acquisition Workstation with Dual Swivel Arms ................100 1.4 Selenia Value Console ......................... 100 2.0 Operating Environment ........................101 2.1 General Operating Conditions ..................... 101 3.0 Storage Environment .......................... 101 3.1 Tubestand ............................
  • Page 9 Instructions for Use Table of Contents Appendix B—The Mobile Selenia 1.0 General Information ...........................115 1.1 The Vertical Position Override Switch (VPOS) ................115 2.0 Safety Conditions and Other Precautions ....................116 3.0 Mobile Specifications .........................117 3.1 Shock and Vibration Limits ......................117 3.2 Coach Environment ........................117 3.3 Electrical Input ..........................117...
  • Page 10 Instructions for Use Table of Contents Part Number MAN-01384...
  • Page 11 Figure 2-9: The Selenia Value Console Controls ..................14 Figure 2-10: Keypad Controls ........................15 Figure 2-11: Selenia Keyboard........................15 Figure 2-12: Selenia Function Keys on the Keyboard .................. 16 Figure 2-13: Totoku Display ........................17 Figure 2-14: Barco Display ......................... 17 Figure 2-15: TechMate Controls and Indicators ..................
  • Page 12 Instructions for Use List of Figures Figure 6-8: Exposure Techniques ....................... 54 Figure 6-9: Breast Density Options......................56 Figure 6-10: Accept TEC Exposure Techniques ..................56 Figure 6-11: The Override Mode........................ 57 Figure 6-12: AEC Exposure and Sensor Position Adjustment On-Screen Settings ........58 Figure 6-13: The Setup Screen ........................
  • Page 13 List of Tables Table P-1: International Symbols ........................ xix Table 1-1: Factors That Limit Exposure Duration ................... 5 Table 2-1: Selenia Function Keys......................... 16 Table 3-1: System Startup Procedures ......................23 Table 3-2: Monthly Control Function Tests ....................25 Table 3-3: The Log Out Methods ......................... 32 Table 4-1: Available Accessories .........................
  • Page 14 Instructions for Use List of Tables Part Number MAN-01384...
  • Page 15 United States Federal Law restricts this device to use by or on the order of a physician. The Selenia is intended to produce radiographic images of the breast. Its intended use is for the production, storage, and diagnostic review of digital screening, diagnostic, and needle localization mammography.
  • Page 16 Indications For Use The Selenia Full Field Digital Mammography System generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammographic systems.
  • Page 17 Instructions for Use Preface Terms and Definitions Terms and Definitions Accession Number A DICOM term that refers to a RIS-created number that uniquely identifies a visit to a site by a patient. American College of Radiology Silver Automatic Exposure Control. A method that limits the amount of radiation a patient receives.
  • Page 18 Tissue Exposure Control mode, an enhanced Manual Exposure Control (MEC) mode. TechMate™ The Hologic SecurView technologist review workstation accessory, as packaged with the Selenia to reduce space in the examination room. technique Combination of X-ray parameters (kV, mA, etc.) for a specified view in a procedure.
  • Page 19 Instructions for Use Preface Warnings, Cautions, and Notes Warnings, Cautions, and Notes Descriptions of Warnings, Cautions, and Notes used in this manual: Procedures that you must follow accurately to prevent WARNING! possible dangerous or fatal injury. Warning: Procedures that you must follow accurately to prevent injury. Caution: Procedures that you must follow accurately to prevent the damage to equipment, loss of data, or damage of files in software applications.
  • Page 20 Chapters 6, 7, and 8 describe the options on the user interface screens while logged on as a “tech”. • Chapter 9 describes system Maintenance and Cleaning procedures. • Appendix A states specifications for the system. • Appendix B provides information about Selenia in a mobile environment. Part Number MAN-01384...
  • Page 21 This system is for use by qualified Operators only. The Operators must have experience in the principles of mammography before following the instructions contained in this manual. The Selenia system is classified as CLASS I, TYPE B permanently connected equipment as per IEC 60601-1. There are no special provisions to protect the system from flammable anesthetics or ingress of liquids.
  • Page 22 Warning: You must keep your complete body behind the radiation shield for the time of the exposure for maximum protection from x-ray exposure. Warning: This device contains dangerous material. Return to Hologic all material removed from service. Part Number MAN-01384...
  • Page 23 Instructions for Use Chapter 1 - General Information Warnings and Precautions Warning: Motorized equipment. Use care when adjusting for patient use. Observe equipment and patient at all times during set up. If a chair is necessary use an adjustable chair set above its minimum height.
  • Page 24 Instructions for Use Chapter 1 - General Information Warnings and Precautions Caution: Never turn off the Acquisition Workstation Circuit Breaker except in emergency. The circuit breaker can turn off the Uninterruptible Power Supply (UPS) and risk data loss. Caution: To minimize possible damage from thermal shock to the Digital Image Receptor, follow the recommended procedure to turn off the equipment.
  • Page 25 Instructions for Use Chapter 1 - General Information Radiation Safety Radiation Safety Exposure Duration Table 1-1: Factors That Limit Exposure Duration Normal Factors Abnormal Factors Manual mAs Timer • Release of the x-ray button before the exposure ends. • Exposure longer than the preset “back-up time” •...
  • Page 26 • The installed network and communications equipment must comply with an IEC Standard, and the complete system (network/communications equipment and Selenia Mammography System) must be installed to comply with IEC 60601-1 and IEC 60601-1-1. Caution:...
  • Page 27 It may be necessary to take mitigation measures, such as re-orienting or relocating the equipment or shielding the location. Caution Changes or modifications not expressly approved by Hologic could void your authority to operate the equipment. Compliance Statements The manufacturer states that this device is manufactured/conforms to: •...
  • Page 28 Instructions for Use Chapter 1 - General Information Label Locations Label Locations Figure 1-1: Selenia Label Locations Part Number MAN-01384...
  • Page 29 Instructions for Use Chapter 1 - General Information Label Locations Figure 1-2: Selenia Value Console Label Locations Part Number MAN-01384...
  • Page 30 Instructions for Use Chapter 1 - General Information Label Locations Part Number MAN-01384...
  • Page 31 Chapter 2 - System Components and Controls System Description Chapter 2 - System Components and Controls System Description The Selenia is available with an Acquisition Workstation or a Value Console. The Acquisition Workstation can also include a technologist review workstation accessory (the Hologic SecurView TechMate ) packaged with the Selenia to reduce space requirements.
  • Page 32 Instructions for Use Chapter 2 - System Components and Controls System Power Controls System Power Controls Input Power Circuit Breakers Location of Circuit Breaker Description • At the lower right corner of the back panel • Removes the power for service or in an emergency •...
  • Page 33 Instructions for Use Chapter 2 - System Components and Controls System Power Controls Emergency Off Switches • Press any Emergency Off Switch to remove Gantry power. • Rotate the switch one-quarter turn to reset. • Restart the system after any Emergency Off Switch is pressed.
  • Page 34 Chapter 2 - System Components and Controls Acquisition Workstation Controls and Display Acquisition Workstation Controls and Display Acquisition Workstation Figure 2-8: The Acquisition Workstation Controls Figure 2-9: The Selenia Value Console Controls Legend for Figure 2-8 Legend for Figure 2-9 Circuit Breaker Computer...
  • Page 35 Close Mode Filter Spot In/out Dens Entry Exam Figure 2-11: Selenia Keyboard Legend for Figure 2-11 1. Selenia Function keys 2. Trackball (Acquisition Workstation) 3. Future Use 4. Standard keyboard keys 5. Standard arrow keys 6. Standard number keypad 7. Mouse (Value Console)
  • Page 36 Chapter 2 - System Components and Controls Acquisition Workstation Controls and Display Keyboard and Screen Controls Use the trackball or the function keys to change Exposure techniques. Figure 2-12: Selenia Function Keys on the Keyboard Table 2-1: Selenia Function Keys Name Function Exposure Mode Changes AEC, TEC, and Manual exposure modes.
  • Page 37 Instructions for Use Chapter 2 - System Components and Controls Acquisition Workstation Controls and Display The Selenia Display Features Display Totoku Display • Has a Power button (2)/On-screen Display Adjustment dial(1). • Green indicator lights when Display is turned on.
  • Page 38 Instructions for Use Chapter 2 - System Components and Controls TechMate Controls and Displays TechMate Controls and Displays Legend for Figure 2-15 TechMate Display TechMate Keyboard TechMate Trackball Power Button for TechMate TechMate UPS Reset Figure 2-15: TechMate Controls and Indicators Part Number MAN-01384...
  • Page 39 Instructions for Use Chapter 2 - System Components and Controls Tubestand Controls and Displays Tubestand Controls and Displays Tubestand Components 1. The Gantry 2. The C-arm Figure 2-16: Tubestand Gantry Controls and Displays Gantry Controls 1. The C-arm Rotation Angle Displays, on both sides of the Gantry, show the C-arm angle.
  • Page 40 Instructions for Use Chapter 2 - System Components and Controls Tubestand Controls and Displays C-arm Controls and Displays 1. Tubehead Controls 2. Compression Device 3. Rear of the C-arm Side Rails 4. Rear of the Image Receptor The Tubehead Controls, on either side of the X-ray tube side covers, provide the Collimator Override, C-arm Rotation, and Light Field functions.
  • Page 41 Instructions for Use Chapter 2 - System Components and Controls Tubestand Controls and Displays 6.2.1 Compression Device Controls and Displays Legend for Figure 2-18 Compression Handwheels AEC Sensor Position controls AEC Sensor Position Display Compression Force Display Compression Thickness Display Figure 2-18: Compression Device Dual Function Footswitches 1.
  • Page 42 Instructions for Use Chapter 2 - System Components and Controls Tubestand Controls and Displays Part Number MAN-01384...
  • Page 43 3. Inspect the paddles for small cracks. 4. Remove any obstructions to the Operator view and C-arm movement. 4. Turn On the Selenia. Turn on the TechMate. (If the Acquisition Workstation or TechMate does not start, reset the UPS for that unit. See Section 4.3, page 30.)
  • Page 44 Instructions for Use Chapter 3 - Startup, Functional Tests, and Shutdown Procedure for Startup Table 3-1: System Startup Procedures Step Description 5. Log on to the Operating System. When the Logon dialog box appears: 1. Enter your user name (case sensitive) for the Operating System. 2.
  • Page 45 Instructions for Use Chapter 3 - Startup, Functional Tests, and Shutdown Controls and Functional Tests Controls and Functional Tests Perform these functional tests monthly. Note… The C-arm movement is disabled when compression force of 58 N (13 lb.) or greater is applied. Table 3-2: Monthly Control Function Tests Function Control...
  • Page 46 Instructions for Use Chapter 3 - Startup, Functional Tests, and Shutdown Controls and Functional Tests Table 3-2: Monthly Control Function Tests Function Control Test Compression Down 1. Press the button. 2. Confirm the compression brake engages and the light field lamp illuminates.
  • Page 47 Instructions for Use Chapter 3 - Startup, Functional Tests, and Shutdown Controls and Functional Tests Table 3-2: Monthly Control Function Tests Function Control Test C-arm Up 1. Press the button. 2. Confirm the C-arm Up movement stops: a. When you release the button.
  • Page 48 Instructions for Use Chapter 3 - Startup, Functional Tests, and Shutdown Controls and Functional Tests Table 3-2: Monthly Control Function Tests Function Control Test Collimator Override 1. Press the light field button then the collimator button. 2. Confirm the Collimator moves to the next field size.
  • Page 49 Instructions for Use Chapter 3 - Startup, Functional Tests, and Shutdown Monthly System Tests Monthly System Tests • Test all Emergency Stop Switches. Follow the on-screen reset procedure. • Change the AEC Sensor Position switch, and make sure the compression device indicator and the Acquisition Workstation display change.
  • Page 50 Instructions for Use Chapter 3 - Startup, Functional Tests, and Shutdown How to Restart the System How to Turn On or Reset the Uninterruptible Power Supply (UPS) UP S LBL-0034 Figure 3-6: The Acquisition Workstation UPS Figure 3-7: Value Console UPS Switch Switch Lever 1.
  • Page 51 Instructions for Use Chapter 3 - Startup, Functional Tests, and Shutdown How to Restart the System UPS Operation for TechMate To reset the TechMate UPS: UP S LBL-00343 Figure 3-8: Reset the TechMate UPS 1. Find the UPS access hole in the middle of the left side of the front cover. This hole aligns with the Power button on the UPS.
  • Page 52 Note… If a message appears and indicates that there are spool jobs, select log off or wait until the jobs are finished. (The spool continues again later.) Hologic recommends that you allow the jobs to complete before shut down. Caution: Do not use a Circuit Breaker or Emergency Off switch as a routine method to turn off the Selenia.
  • Page 53 10 cm Rectangular Open 15 cm Rectangular Open Patient Face Shield Magnification Platform Localization Crosshair Device Magnification Crosshair Device Note… On the Selenia S system, only use the 7.5 cm Spot Contact Paddle for compression thickness calibration. Part Number MAN-01384...
  • Page 54 Instructions for Use Chapter 4 - The Selenia Accessories Patient Face Shield Patient Face Shield Remember to examine the Face Shield condition before use each day. How to Install the Face Shield on the Tubehead 1. Put the tab ends on the open end of the Face Shield into the slots on the tubehead mount.
  • Page 55 Instructions for Use Chapter 4 - The Selenia Accessories Compression Paddles Compression Paddles There are 19 compression paddles for Screening and Diagnostic Procedures. 12 of the 19 paddles are Smart Paddles and have mechanisms that allow manual lateral movement (both left and right).
  • Page 56 Instructions for Use Chapter 4 - The Selenia Accessories Compression Paddles Smart Paddle System A release knob on each side of the Smart Paddle allows it to move from one side of the image detector to the other. This enables the Technologist to optimize the breast position and imaging within the active area of the Image Receptor, especially when Lateral Views of a small breast are required.
  • Page 57 Instructions for Use Chapter 4 - The Selenia Accessories Compression Paddles How to Realign the Paddle Front Edge 1. Install the paddle and apply 30 lb (132 N) of compression force. 2. Make sure that the front edge is aligned to the front edge of the Image Receptor.
  • Page 58 Instructions for Use Chapter 4 - The Selenia Accessories Compression Paddles Identification of Compression Paddles 3.7.1 Routine Screening Paddles 18 x 24 cm FAST Paddle 18 x 24 cm Screening Paddle 24 x 30 cm FAST Paddle 24 x 30 cm Screening Paddle Small Breast Paddle 3.7.2...
  • Page 59 Instructions for Use Chapter 4 - The Selenia Accessories Compression Paddles 3.7.3 Magnification Paddles 7.5 cm Spot Magnification 10 cm Magnification 15 cm Magnification Paddle Paddle Paddle 10 cm Magnification 10 cm Magnification Localization Paddle Perforated Localization Paddle Use the Magnification paddles when the Magnification Platform is installed.
  • Page 60 Instructions for Use Chapter 4 - The Selenia Accessories Magnification Platform Magnification Platform When the Magnification Platform is installed, the HTC grid automatically retracts and the default values for Magnification x-ray exposure techniques are set. How to Install the Magnification Platform 1.
  • Page 61 Instructions for Use Chapter 4 - The Selenia Accessories The Localization Crosshair Device The Localization Crosshair Device The Localization Crosshair device, used with a localization paddle enables the location of a specified spot on the breast. How to Install the Crosshair Device Figure 4-7: Installation of the Crosshair Device 1.
  • Page 62 Instructions for Use Chapter 4 - The Selenia Accessories The Magnification Crosshair Device Localization Crosshair Device to the Localization Paddle Alignment Note… Before you perform the following adjustment, make sure the Localization paddle is aligned to the edge of the image receptor. Refer to “How to Realign the Paddle Front Edge,”...
  • Page 63 Instructions for Use Chapter 5 - The User Interface The Three Main User Interface Screens Chapter 5 - The User Interface The Three Main User Interface Screens The process of image acquisition, enhancement, and output is done through three screens: •...
  • Page 64 Instructions for Use Chapter 5 - The User Interface A Screening Exam Sequence Suggestion A Screening Exam Sequence Suggestion Table 5-1: Workflow Suggestions to Select a Patient and Acquire an Image Action What it looks like 1. Start up the system and log in to Operating System and Application.
  • Page 65 Instructions for Use Chapter 5 - The User Interface A Screening Exam Sequence Suggestion Table 5-1: Workflow Suggestions to Select a Patient and Acquire an Image Action What it looks like 3. Select the Procedure, when more than one is scheduled.
  • Page 66 Instructions for Use Chapter 5 - The User Interface A Screening Exam Sequence Suggestion Table 5-1: Workflow Suggestions to Select a Patient and Acquire an Image Action What it looks like 7. Select the Exposure Techniques. • Use default values for selected exposure mode.
  • Page 67 Instructions for Use Chapter 6 - The Select a Patient Screen Introduction Chapter 6 - The Select a Patient Screen Introduction The Select a Patient screen appears when the system application loads. This screen allows you to locate a patient, and access non-routine Acquisition Workstation options with no patient selected.
  • Page 68 Instructions for Use Chapter 6 - The Select a Patient Screen Select a Patient Select a Patient A patient can be added to the system or already exist and be selected from a list. There are two places to search for an existing patient, the worklist which is a list of scheduled patients from a Modality Worklist Provider and the Local Exams which are the patients on the computer in the workstation.
  • Page 69 Instructions for Use Chapter 6 - The Select a Patient Screen How to Add a New Patient How to Add a New Patient The Patient area of the screen allows you to Add a New Patient and Edit the existing patient information.
  • Page 70 Make the patient information changes on the PACS if the images were sent to the Selenia. • Any patient information changes on the Selenia must be a last option. Some RIS systems do not have the ability to change this information at the Selenia. •...
  • Page 71 Instructions for Use Chapter 6 - The Select a Patient Screen New, Edit, Add a Procedure Remove any wrong images from: • Printer • Diagnostic Review Workstation • PACS Correct the information at the AWS: 1. Select the Local Exams tab and search for the patient. •...
  • Page 72 Instructions for Use Chapter 6 - The Select a Patient Screen New, Edit, Add a Procedure Figure 6-5: New Procedure Dialog Box Note… The Cancel button closes the dialog box without any changes. The Clear button clears the Accession number. 5.
  • Page 73 Instructions for Use Chapter 6 - The Select a Patient Screen Image Output Image Output Figure 6-7: Select the Output Before acquiring an Image, verify that you selected the correct output. All real patient images must be printed or committed to a PACS. Select the Output group to use for this procedure from the drop down list.
  • Page 74 Instructions for Use Chapter 6 - The Select a Patient Screen Exposure Information Exposure Information The Exposure Pane Figure 6-8: Exposure Techniques The top, left side displays the status of these options: • Compression Force Mode • Compression Release • Compression Thickness •...
  • Page 75 Instructions for Use Chapter 6 - The Select a Patient Screen Exposure Information About Exposure Modes Table 6-2: Exposure Modes Exposure Operator Adjustments Where the function is in the Techniques Pane Modes (#1) Auto-Filter Select the AEC Exposure (#2); AEC Sensor (#3) (Positions 1-7 or Auto).
  • Page 76 Instructions for Use Chapter 6 - The Select a Patient Screen Exposure Information 7.2.2 About the TEC Exposure Mode The Tissue Exposure Control (TEC) Mode is an enhanced Manual Exposure Control mode. 1. Before you position and compress the breast, select the Breast Density type on the Acquisition Workstation screen or press the Breast Density key.
  • Page 77 Instructions for Use Chapter 6 - The Select a Patient Screen Exposure Information Figure 6-11: The Override Mode There are three methods to exit the Override Mode and return to TEC mode: • Change the Breast Density setting. • Release the compression then compress the breast. •...
  • Page 78 Instructions for Use Chapter 6 - The Select a Patient Screen Exposure Information Figure 6-12: AEC Exposure and Sensor Position Adjustment On-Screen Settings 7.2.5 AEC Sensor Position Indicator Settings Select one of the seven positions to indicate the area of interest for AEC calculations. Or, select Auto AEC where a larger area is tested.
  • Page 79 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar Menu Bar The Menu Bar provides easy access to non-routine Acquisition Workstation options. These options are available while the Acquisition Workstation application runs unless a dialog box or Procedure is opened.
  • Page 80 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar Edit Menu Function 8.1.1 Standard Setup Screens Figure 6-13: The Setup Screen 1. Select Edit>Standard Setup. 2. Use the trackball or the keyboard Tab key to move between fields. 3.
  • Page 81 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar 8.1.3 View Order Editor Figure 6-14: View Order Editor 1. Select Edit>View Order Editor. 2. Select the procedure from the drop-down menus. 3. Select the Views for each Procedure: 4.
  • Page 82 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar 8.1.4 Add or Edit a User A signed-in user can add or delete a user at the same or lower level. To access the Edit User options, select Edit>User Setup. Figure 6-15: The Edit Users Dialog Box Table 6-5: User Setup Options Option...
  • Page 83 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar 8.1.5 Outputs To Add New Output Groups: 1. Select Edit > Outputs. 2. Select New. 3. Enter the name for this Output. 4. Select OK. 5. Select the new name in the Edit Outputs dialog box. 6.
  • Page 84 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar To Edit Outputs: 1. Select Edit > Outputs. 2. Select an Output name. If the Output keeps its current name, go to step 7. 3. Select the Copy button. 4.
  • Page 85 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar Admin Menu 8.2.1 Image Management 1. Select Admin>Image Management. The Choose a New Patient dialog box appears. Figure 6-17: Choose a New Patient Dialog Box 2. Select the Patient Name tab or the Patient ID tab. 3.
  • Page 86 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar 8.2.2 The Resend Options Figure 6-18: Image Management Resend Options 1. Select the resend button. • To resend all images on the hard disk drive for this patient, select Resend All Images.
  • Page 87 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar 8.2.3 The Repreview Option 1. Select the thumbnail image to review. 2. Select the Repreview tab, then select the Repreview button. 3. When you finish reviewing, select the Cancel button. 4.
  • Page 88 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar 8.2.5 Manage Queues Use Manage Queues to find problem jobs or a specified job in the queues. Warning: If you select Delete Job, you cannot undo the deletion. If it still needs to be sent, resend the job to a storage device later.
  • Page 89 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar Table 6-6: How to Use Manage Queues Option Steps • To resend a stopped job: 1. Select the queue in the Devices list. 2. Select a job marked ‘Stopped’ from the Queued Jobs list, or Ctrl+click to select many jobs.
  • Page 90 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar 8.2.8 Retrieve Priors To find the Images in the Local Database, select the Local Exams tab and search for the Patient. To Retrieve Priors from the PACS system: 1.
  • Page 91 Instructions for Use Chapter 6 - The Select a Patient Screen Menu Bar 8.2.11 Test Patterns 1. Select Admin>Test Patterns. 2. Select the Preview size (Figure 6-20, No. 1). 3. Select the Test Pattern from the Pattern field (No. 2). 4.
  • Page 92 Instructions for Use Chapter 6 - The Select a Patient Screen Special Modes Buttons 8.2.13 Available Disk Space This option displays the remaining number of images the hard disk drive and CD can hold. The system automatically deletes some Images/Patients at specified levels to get back hard disk drive storage space for new Procedures.
  • Page 93 Instructions for Use Chapter 6 - The Select a Patient Screen Generator Status The Simulate Capture Button This function is for use by service personnel. 10.0 Generator Status This area displays the current status of the system. See Figure 6-1, page 47. 11.0 System Messages The System Messages area displays the system status.
  • Page 94 Instructions for Use Chapter 6 - The Select a Patient Screen Alarms Part Number MAN-01384...
  • Page 95 Instructions for Use Chapter 7 - The Patient Views Screen Chapter 7 - The Patient Views Screen When you select a Patient, the Views for the scheduled Procedure display on the Patient View screen in your preset order. The program automatically highlights the first View in the sequence.
  • Page 96 Instructions for Use Chapter 7 - The Patient Views Screen Work with Views Work with Views Figure 7-2: Buttons Used on the View Screen Table 7-2: View Options Option Actions Add View (1) 1. Select the Add View button. 2. Select an additional View from the list of Standard Mammography Views.
  • Page 97 Instructions for Use Chapter 7 - The Patient Views Screen Acquire Images Acquire Images The system is ready to acquire Images when the Generator Status indicates “Ready” (Figure 7-3, #1), and the X through the X-ray symbol (#2) in the Generator Status box is not displayed.
  • Page 98 Instructions for Use Chapter 7 - The Patient Views Screen Acquire Images Part Number MAN-01384...
  • Page 99 Instructions for Use Chapter 8 - The Preview Image Screen Introduction Chapter 8 - The Preview Image Screen Introduction The Preview Image screen appears when you acquire an image. The right side of the screen has image tools and buttons to accept or reject the image. Figure 8-1: The Preview Image Screen Legend for Figure 8-1 1.
  • Page 100 Instructions for Use Chapter 8 - The Preview Image Screen The Preview Image Film Label Area The film label area which is the small rectangle in the upper, left corner is blank in the Preview. A Digital Marker next to the label displays the Technologist initials and the marker for the selected View.
  • Page 101 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation Tools for Image Enhancement and Annotation Comments Markers Edit View Implant Present Zoom/Pan Thumbnail Crosshair Measurement Window/Level ROI size Drop-down Set Center/Width Display AEC Regions Exposure Index Exposure Techniques Reprocess View...
  • Page 102 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation Comments The comment text is inserted in the DICOM header of the Acquired Image. The diagnostic review workstation displays the comments. Figure 8-4: Image Comments 1.
  • Page 103 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation The Edit View Button and Markers Select the Edit View button to update the DICOM header and enable the image to hang correctly at the Diagnostic Review Workstation.
  • Page 104 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation Implant Present Select the checkbox on the Patient View screen when an implant exists. When the checkbox is selected, the system marks future images with an Implant Present label. The checkbox on this screen enables you to change the selection before you accept the image.
  • Page 105 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation Figure 8-7: ROI Size Drop-down Menu Method 1: Draw a custom box. Method 2: Use a pre-defined box size. 1. Select the ROI button. 1.
  • Page 106 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation Crosshairs Figure 8-8: Preview with Crosshairs 1. Install a localization paddle. 2. Acquire the image. 3. If necessary, select the Zoom/Pan button and move through the image. 4.
  • Page 107 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation Measurement Figure 8-9: A Measurement on the Preview Screen 1. Select the Measurement button. 2. Click the first point then drag to the second point. The distance displays when you release the button.
  • Page 108 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation Magnification Use the Magnification function to view part of the image at 2X the displayed resolution. 1. Select the Magnification button. 2. Move the box that appears at the area of interest. 3.
  • Page 109 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation 3.10 Window/Level 1. Select the Window/Level button. 2. Select in the image and hold while you move the trackball. • Roll Up or Down to change the brightness (Level). •...
  • Page 110 Instructions for Use Chapter 8 - The Preview Image Screen Tools for Image Enhancement and Annotation 3.11 Display AEC Regions To display the AEC area selected by the system, select the Display AEC Regions checkbox. • Manual sensors show on the image as a white rectangle with rounded corners. •...
  • Page 111 Instructions for Use Chapter 8 - The Preview Image Screen Accept or Reject 3.12 Exposure Index Use the Exposure Index as a general guide to compare the selected Exposure Techniques to the quality of the acquired image. • “Image Status: OK” indicates the image processing was applied. •...
  • Page 112 Instructions for Use Chapter 8 - The Preview Image Screen Accept or Reject Reject To reject the image: 1. Select the Reject button. Note… Reject Analysis uses this information (required for Quality Control). Figure 8-15: The Reject Reasons List 2. Select the reason for the reject. 3.
  • Page 113 Instructions for Use Chapter 8 - The Preview Image Screen Additional information about Accepted/Rejected Images Additional information about Accepted/Rejected Images After you reject an image, the Preview closes and you can: • Re-acquire the rejected View. • Select a different View. •...
  • Page 114 Instructions for Use Chapter 8 - The Preview Image Screen Additional information about Accepted/Rejected Images When you accept a rejected image, the Send Image to Output dialog box displays. Select Yes to send the images to the selected output group. Note…...
  • Page 115 Use a lint-free cloth or pad and apply a diluted dishwashing liquid. Caution: The fluid must not drip or run. If more than soap and water is required, Hologic recommends any one of the following: • 10% chlorine bleach and water with one part commercially available chlorine bleach (normally 5.25% chlorine and 94.75% water) and nine parts water...
  • Page 116 Instructions for Use Chapter 9 - Maintenance and Cleaning Care and Cleaning—Acquisition Workstation and Value Console • Never allow any liquids to enter the internal parts of the equipment. Do not apply cleaning sprays or liquids to the equipment. Always use a clean cloth and apply the spray or liquid.
  • Page 117 Instructions for Use Chapter 9 - Maintenance and Cleaning Preventive Maintenance Preventive Maintenance Table 9-1: User Preventive Maintenance Recommended Frequency Each Semi- Maintenance Task Description Daily Weekly Biweekly Monthly Quarterly annually Clean & disinfect paddle Clean & disinfect breast platform Visually inspect all paddles for damage Recommended/ required start of operation verifications...
  • Page 118 Instructions for Use Chapter 9 - Maintenance and Cleaning Preventive Maintenance Part Number MAN-01384...
  • Page 119 User Manual Appendix A—System Specifications Dimensional Information Appendix A—System Specifications Dimensional Information Tubestand (Gantry with C-arm) Figure A-1: Tubestand Dimensions Height 190.0 cm (74.8 in.)±1.0 cm (0.4 in.); 213.0 cm (84.0 in.) ±1.0 cm (0.4 in.) at highest C-arm travel Width 65.0 cm (25.6 in.) ±1.0 cm (0.4 in.) (C-arm at 0°...
  • Page 120 195.6 cm (77.0 in.) (H) x 107 cm (42.1 in.) (W) x 76 cm (30.0 in.) (D) (maximum) Weight 218 kg (480 lb) Selenia Value Console Figure A-4: Value Console Dimensions Overall Dimensions 189.4 cm (74.6 in.) (H) x 101.2 cm (39.8 in.) (W) x 60.5 cm (23.8 in.) (D) (maximum)
  • Page 121 User Manual Appendix A—System Specifications Operating Environment Operating Environment General Operating Conditions Temperature Range 20 °C (68° F) to 30 °C (86° F) Maximum rate of temperature change <10 ºC/hr Relative Humidity Range 10% to 80% non-condensing BTU output Typical Range 1700–2500 BTU/hr Storage Environment Tubestand Temperature Range...
  • Page 122 User Manual Appendix A—System Specifications Acquisition Workstation Technical Information Acquisition Workstation Technical Information Operating System Sun™ Solaris OS Computer Memory 2 GB RAM minimum Disk capacity > 60 GB Image Storage Storage Media CD-RW Disks Display Adapter Card 1600 x 1200 matrix minimum 8 bit gray scale display Display 1600 x 1200 matrix minimum 450 cd/m2 nominal brightness...
  • Page 123 User Manual Appendix A—System Specifications Tubestand Technical Information Tubestand Technical Information C-arm Motorized C-arm Rotation Speed Variable speed (18° per second maximum). Rotation speed is service selectable: 50% to 100% in 5% increments. Motor Control provides soft start and dynamic braking. C-arm Rotation Range +195°...
  • Page 124 User Manual Appendix A—System Specifications Tubestand Technical Information Compression Down Motion Service Selectable between approximately 10% Variable Speed through 100% of full speed. Compression Force Display Two LED Displays on the Compression Device show the compression force through the range of 10 lb to 67.4 lb (44.5 N to 300 N) in 1 lb (4.4 N) increments.
  • Page 125 User Manual Appendix A—System Specifications Tubestand Technical Information 6.3.2 X-ray Beam Filtration and Output Inherent Tube Filtration 0.0 mm Al equivalent Added Filtration Two-position filter changer mechanism to carry a 30-micron (0.03 mm) Molybdenum foil filter and a 30-micron (0.03 mm) Rhodium foil Filter. Type of filter is user selectable.
  • Page 126 User Manual Appendix A—System Specifications Tubestand Technical Information X-ray Tube: Tungsten Focal Spot (NEMA / IEC) Large (0.3 mm) Nominal Small (0.1 mm) Nominal Tube Voltage 22 kV to 39 kV Tube Current Large Focal Spot = 100 mA between 25 and 32 kV Small Focal Spot = 30 mA between 25 and 32 kV Anode Rotation 180 Hz (9500 RPM minimum)
  • Page 127 User Manual Appendix A—System Specifications Tubestand Technical Information X-ray Collimation Available Collimated X-ray Fields: Table A-1: Collimation Settings Predefined Collimation Settings 24 x 29 cm 18 x 24 cm 15 x 15 cm 10 x 10 cm 7.0 x 8.5 cm Light Field Indication Light Field Lamp Illuminates for 30 seconds, ±5 seconds, upon...
  • Page 128 User Manual Appendix A—System Specifications Tubestand Technical Information 6.7.1 kV /mA Range Table A-2: mA setting as a function of kV Large Focal Spot 75 mA 80 mA 85 mA 90 mA 95 mA 25-32 100 mA 85 mA 34-35 80 mA 36-37 75 mA...
  • Page 129 User Manual Appendix A—System Specifications Tubestand Technical Information Large Focal Spot Manual mAs Range: TABLE 1 (default): 3 mAs through 400 mAs, 22 steps: 3, 4, 5, 6.4, 8, 10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80, 100, 125, 160, 200, 250, 320, 400.
  • Page 130 User Manual Appendix A—System Specifications Imaging System Technical Information Imaging System Technical Information Image Receptor Fluid ingress No fluid from incidental spillage on the top surface of the Image Receptor seeps inside Deflection Does not exceed 1.0 mm at maximum compression Active Imaging Area 24 cm x 29 cm Nominal.
  • Page 131 User Manual Appendix A—System Specifications Tissue Exposure Control (TEC) Mode—Enhanced Manual Mode Tissue Exposure Control (TEC) Mode—Enhanced Manual Mode The Breast Density Default Setting Selectable via the Generator default screen on the Acquisition Workstation. Breast density defaults to the default setting at the beginning of each new study and when the exposure mode is first changed to TEC.
  • Page 132 30 msec when the grid is out of the x-ray field. The user releases the exposure button prematurely. There is an error within the Selenia FFDM system. AEC Reproducibility AEC exposure reproducibility meets MQSA...
  • Page 133 User Manual Appendix A—System Specifications Hardcopy Film Printing Devices 10.0 Hardcopy Film Printing Devices This section lists the relevant technical characteristics for the hardcopy film printing device. 10.1 Image Engine Film sizes 20 cm x 25 cm (8 in. x 10 in.) 25 cm x 30 cm (10 in.
  • Page 134 User Manual Appendix A—System Specifications TechMate Part Number MAN-01384...
  • Page 135 The Vertical Position Override Switch (VPOS) The Mobile Selenia has a Vertical Position Override Switch (VPOS) on the back of the Gantry (see Figure B-1.) This switch can start the Selenia if the C-arm is lower than its normal operating position after rough-road travel.
  • Page 136 When the unit is not in use, do not allow environmental parameters to be more than specified specifications. Caution: When in use, connect the Selenia to a PACS system or an acceptable hard copy printer for permanent archive. Part Number MAN-01384...
  • Page 137 Instructions for Use Appendix B—The Mobile Selenia Mobile Specifications Mobile Specifications Shock and Vibration Limits Vibration Limit Not greater than 0.35 G (2 Hz to 200 Hz), as measured at mounting point of system to coach. Shock Limit Not greater than 1.0 G (½ sine pulse), as measured at mounting point of system to coach.
  • Page 138 Instructions for Use Appendix B—The Mobile Selenia How to Prepare the System for Transport How to Prepare the System for Transport Perform these steps before you transport the Mobile System: 1. Rotate the C-arm to 0 degrees (CC position). 2. Lower the C-arm to its lowest position.
  • Page 139 Instructions for Use Index Index button compression release 15 accept Eject, on CD-RW drive 69 image 91 on and x-ray 15 rejected image 93 button (software) – Accept button 44 Accept 49 accessories 1 Add View 45 available 33 Brightness/Contrast (Window/Level) 89 –...
  • Page 140 Instructions for Use Index CD, CD-RW contrast, change for printer 67 – available space on 72 controls 12 ejecting disks 69 AEC sensor position 21 importing images from 69 automatic compression release 26 – CD-RW Drive C-arm 20 Eject button 69 C-arm rotation 20 location 14 collimator override 20...
  • Page 141 29 enhancement tools list 81 enter new patient data 49 hanging options 80 entrance surface exposure display 91 Hologic technical support 95 environment 101 equipment damage, prevention 95 exam room door indicators 5 exposure image display area 79...
  • Page 142 Instructions for Use Index Implant Present 76 manual collimation, effects 60 button 84 Manual exposure mode 55 import Markers 83 image files 69 digital 80 priors in background 70 indicator, exam door 5 focal spots manual range 109 infectious materials on equipment 95 select 16 Info menu 72 Measurement button 87...
  • Page 143 Instructions for Use Index Patient add new 49 radiation symbol, X-ray indicator 15 edit data 50 raw image status 91 Face Shield 5 Ready 77 protecting from reclamation 67 recommended cleaning solutions 95 unprotect 67 Region of Interest (ROI), button 85 Patient Name, tab for local database 48 region used to calculate exposure index 91 Patient View screen 43...
  • Page 144 16 exposure modes 111 outputs 53 printers 113 Select a Patient screen 43 TechMate 113 Selenia Display 14 technologist review workstation 11 send technologist, default view order 75 accepted rejected images to outputs 94 temperature (IR) 72 images to an output-post procedure 66...
  • Page 145 Instructions for Use Index view default order 75 prior images on AWS 70 rejected image 93 selecting 75 View Order Editor screen 61 – warnings, cautions and notes xix defined xix Window/Level 89 worklist 48 tab 48 x-ray collimated fields 28 indicators 15 x-ray symbol 77 x-ray tube...
  • Page 146 Instructions for Use Index Part Number MAN-01384...
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