Intended Use for the User Guide .......................... 2 Summary of Clinical Studies ..........................2 Product Complaints ..............................2 Technical Support ..............................2 Hologic Cybersecurity Statement ......................... 3 Quality Control Requirements ..........................3 Installation Instructions ............................3 User Profiles................................4 1.9.1 Mammography Technologist ........................
Page 6
How to Turn Off the UPS .......................... 39 How to Log Out ..............................40 How to Shut Down the System ........................... 41 Chapter 5 The Selenia Accessories _______________________________________________43 Patient Face Shield ..............................43 5.1.1 How to Install the Face Shield on the Tubehead ................... 43 5.1.2...
Page 7
Selenia User Guide Table of Contents The Localization Crosshair Device ........................51 5.4.1 How to Install the Crosshair Device ......................51 5.4.2 How to Remove the Crosshair Device ....................51 5.4.3 Localization Crosshair Device to the Localization Paddle Alignment ..........52 The Magnification Crosshair Device ........................
Page 8
Image Engine ............................124 A.10.2 Interface..............................125 A.10.3 Printed Film ............................125 Appendix B The Mobile Selenia ________________________________________________127 General Information ............................127 B.1.1 The Vertical Position Override Switch (VPOS) ..................127 Safety Conditions and Other Precautions ....................... 129 Mobile Specifications ............................130 B.3.1...
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.
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.
Chapter 1—Introduction 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.
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. MAN-03270 Revision 003...
Selenia User Guide Chapter 1—Introduction 1.11 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
Selenia User Guide Chapter 1—Introduction Outputs A list of devices to which the accepted image is sent. The devices can be a combination of archives, workstations and film printers. PACS Picture Archiving and Communications System. A computer and network system for the transfer and archive of digital...
"ON" (power) "OFF" for part of the equipment "ON" for part of the equipment Power Standby Discard electrical and electronic equipment separately from standard waste. Send decommissioned material to Hologic or contact your service representative. Dangerous Voltage Manufacturer Date of Manufacture Caution—Radiation...
Selenia User Guide Chapter 1—Introduction 1.13 Warnings, Cautions, and Notes Descriptions of Warnings, Cautions, and Notes used in this manual: The procedures that you must follow accurately WARNING! to prevent possible dangerous or fatal injury. The procedures that you must follow accurately to Warning: prevent injury.
WARNING! equipment to supply mains with Protective Earth. Only trained Service Engineers authorized WARNING! through Hologic can open any of the panels. This system contains lethal voltages. Electrical equipment used near flammable WARNING! anesthetics can cause an explosion. After power failure, remove the patient from the WARNING! system before you apply power.
Page 22
Selenia User Guide Chapter 2—General Information Keep a 1.5 meter safe distance between the WARNING! patient and any non-patient devices. Do not install non-patient system components (like the Workflow Manager, the diagnostic review workstation, or the hard copy printer) in the Patient Area.
Page 23
Selenia User Guide Chapter 2—General Information This device contains dangerous material. Send Warning: decommissioned material to Hologic or contact your service representative. The equipment has motors. You must be careful Warning: when you adjust the equipment for patient use. Observe equipment and patient at all times during setup.
Page 24
Selenia User Guide Chapter 2—General Information The Face Shield does not protect the patient from Warning: radiation. Do not use any hot source (like a heating pad) on the Caution: image receptor. Never turn off the Acquisition Workstation or Value Caution: Console Circuit Breaker except in emergency.
Selenia User Guide Chapter 2—General Information Radiation Safety 2.2.1 Exposure Duration Table 1: Factors That Limit Exposure Duration Normal Factors Abnormal Factors Manual mAs Release of the X-ray button before the exposure • Timer ends. Exposure longer than the preset "back-up time"...
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. Medical Electrical Equipment needs special precautions...
Changes or modifications not expressly approved by Caution: Hologic could void your authority to operate the equipment. 2.6.2 Compliance Statements The manufacturer states this device is made to meet the following requirements: CAN/CSA - ISO 13485-03 Medical Devices –...
Page 28
Selenia User Guide Chapter 2—General Information IEC 60601-1-1Ed. 2.0:2000 Medical Electrical Equipment - Part 1-1: General • Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems IEC 60601-1-2 Ed. 3.0:2007 Medical Electrical Equipment – Part 1-2: General •...
Selenia User Guide Chapter 2—General Information Table 2: Label Descriptions Label Identification Description Serialized Device Label X-ray Tube Serial Number Emergency Stop Switch Wheelchair Warning for Footswitch Vendor Footswitch Label Electrical Shock Warning Patent Label System Nameplate Label for IEC 60601-1 Third...
Page 31
Selenia User Guide Chapter 2—General Information Table 2: Label Descriptions Label Identification Description Acquisition Workstation Nameplate Label for IEC 60601-1 Third Edition Compliant Systems Acquisition Workstation Nameplate Label for IEC 60601-1 Second Edition Compliant Systems UL (Underwriters Laboratories) Certification Label for IEC 60601-1 Third Edition Compliant...
Page 32
Selenia User Guide Chapter 2—General Information Table 2: Label Descriptions Label Identification Description Temperature Limit Label Patient Dose Label MAN-03270 Revision 003...
Chapter 3—System Components and Controls Chapter 3 System Components and Controls Chapter 3 System Description The Selenia is available with an Acquisition Workstation or a Value Console. Figure 3: Selenia System Description Figure Legend Selenia Acquisition Workstation Contain the image processing electronics and show the user interface.
Selenia User Guide Chapter 3—System Components and Controls Film Printer Selenia accepts film printers. Printed films display the patient information, exposure techniques, projection, and facility information. System Power Controls 3.3.1 Input Power Circuit Breakers Location of Circuit Breaker Description At the lower right corner of •...
Selenia User Guide Chapter 3—System Components and Controls 3.3.2 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. (See the procedure in...
X-ray buttons, one on each side of the keyboard. Press both at the same time to begin an x-ray exposure and hold until the tone stops. Compression Release button 3.4.3 Keyboard and Trackball or Mouse Figure 13: Selenia Keyboard Figure Legend Selenia Function keys Trackball (Acquisition Workstation) (Future Use)
Selenia User Guide Chapter 3—System Components and Controls 3.4.4 Keyboard and Screen Controls Use the trackball or the function keys to change Exposure techniques. Figure 14: Selenia Function Keys on the Keyboard Table 3: Selenia Function Keys Name Function Exposure Changes AEC, TEC, and Manual exposure modes.
Selenia User Guide Chapter 3—System Components and Controls 3.4.6 The Selenia Display Features Display Meets the DICOM requirements. • Press the recessed dial (on the right • side) to show a menu. Press and hold the recessed dial to •...
Selenia User Guide Chapter 3—System Components and Controls 3.5.1 Gantry Controls and Displays Gantry Controls The C-arm Rotation Angle Displays on both sides of the Gantry show the C-arm angle. The Emergency Off Switches on each side of the Gantry remove power from the Tubestand.
Selenia User Guide Chapter 3—System Components and Controls The Compression Device contains the AEC Sensor control and position LEDs, and displays compressed breast thickness and force. Handwheels allow manual compression control. The rear edges of the C-arm Side Rail have recessed push-button controls for motorized compression and C-arm movement.
Selenia User Guide Chapter 3—System Components and Controls 3.5.3 Dual Function Footswitches Press the footswitch to activate. Release the footswitch to stop motorized movement. Figure Legend C-arm Down C-arm Up Compression Down Compression Up Figure 18: The Dual Function Footswitch...
Selenia User Guide Chapter 4—Startup, Functional Tests, and Shutdown Chapter 4 Startup, Functional Tests, and Shutdown Chapter 4 Procedure for Startup Table 4: System Startup Procedures Step Description Reset the Emergency Off Switches. Figure 19: Emergency Off Switch • Two on the Gantry •...
Inspect the paddles for small cracks and wear. d. Remove any obstructions to the Operator view and C-arm movement. Turn On the Selenia. (If the Acquisition Workstation does not start, reset the UPS for that unit. See How to Turn On or Reset the Uninterruptible Power Supply (UPS) on page 39.)
Selenia User Guide Chapter 4—Startup, Functional Tests, and Shutdown Note If the system was turned off for 30 minutes or longer, the detector temperature needs time to adjust. Allow a minimum of 1 hour before you acquire images on a patient.
Page 46
Selenia User Guide Chapter 4—Startup, Functional Tests, and Shutdown Table 5: Monthly Control Function Tests Function Control Test Clockwise C-arm Rotation C-arm and Gantry Rotation Press the button and confirm the Switches following actions: C-arm rotates • Angle display changes •...
Page 47
Selenia User Guide Chapter 4—Startup, Functional Tests, and Shutdown Table 5: Monthly Control Function Tests Function Control Test Compression Up Press the button. Confirm the compression brake does not release. Confirm the Compression Up movement stops: When the Compression •...
Page 48
Selenia User Guide Chapter 4—Startup, Functional Tests, and Shutdown Table 5: Monthly Control Function Tests Function Control Test C-arm Down Press the button. Confirm the C-arm Down movement stops: When you release the • button. When the C-arm reaches the •...
Page 49
Selenia User Guide Chapter 4—Startup, Functional Tests, and Shutdown Table 5: Monthly Control Function Tests Function Control Test Smart Paddle Install a Smart Paddle. Rotate the release knob on the side of the paddle from the lock to the shift position.
Selenia User Guide Chapter 4—Startup, Functional Tests, and Shutdown 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.
Selenia User Guide Chapter 4—Startup, Functional Tests, and Shutdown 4.4.3 How to Turn On or Reset the Uninterruptible Power Supply (UPS) Figure 23: The Acquisition Workstation UPS Switch Lever Figure 24: Value Console UPS Switch Find the Acquisition Workstation UPS...
Selenia User Guide Chapter 4—Startup, Functional Tests, and Shutdown How to Log Out There are two methods to log out of the application. The system will remain on and another user can log in to use it. Table 6: The Log Out Methods...
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. Do not use a circuit breaker or Emergency Off switch as a Caution: routine method to turn off the Selenia.
Selenia User Guide Chapter 5—The Selenia Accessories Chapter 5 The Selenia Accessories Chapter 5 Patient Face Shield Remember to examine the Face Shield condition before use each day. 5.1.1 How to Install the Face Shield on the Tubehead Put the tab ends on the open end of the Face Shield into the slots on the tubehead mount.
Selenia User Guide Chapter 5—The Selenia Accessories Compression Paddles There are 19 compression paddles for Screening and Diagnostic Procedures. Twelve of the nineteen paddles are Smart Paddles and have mechanisms that allow manual lateral movement (both left and right). The x-ray collimation moves with the Shifting Compression Paddle position.
Selenia User Guide Chapter 5—The Selenia Accessories 5.2.4 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.
Selenia User Guide Chapter 5—The Selenia Accessories The FAST paddle does not require excessive compression, but you must use enough compression to prevent the movement of the breast. You should use a consistent amount of compression, especially for related left and right views.
Selenia User Guide Chapter 5—The Selenia Accessories 5.2.7 Identification of Compression Paddles 5.2.7.1 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 5.2.7.2...
Page 60
Selenia User Guide Chapter 5—The Selenia Accessories 5.2.7.3 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.
Selenia User Guide Chapter 5—The Selenia Accessories 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. 5.3.1 How to Install the Magnification Platform Remove the Face Shield (see Patient Face Shield on page 43).
Selenia User Guide Chapter 5—The Selenia Accessories 5.3.2 How to Remove the Magnification Platform Remove the Magnification paddle. Press the locking clips on the Magnification Platform down to release the hooks. Lift the Magnification Platform up and out by the support bracket.
Selenia User Guide Chapter 5—The Selenia Accessories The Localization Crosshair Device The Localization Crosshair device, used with a localization paddle enables the location of a specified spot on the breast. 5.4.1 How to Install the Crosshair Device Figure 33: Installation of the Crosshair Device Remove the Face Shield from the tubehead.
Selenia User Guide Chapter 5—The Selenia Accessories 5.4.3 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. (See How to Realign the Paddle Front Edge on page 46.)
Page 65
Selenia User Guide Chapter 6—The User Interface Chapter 6 The User Interface Chapter 6 Introduction to the User Interface The process of image acquisition, enhancement, and output is done through three screens: Select a Patient screen • Patient Views screen •...
Selenia User Guide Chapter 6—The User Interface Select a Patient Screen 6.2.1 Introduction The Select a Patient screen appears when the system application loads. This screen allows you to locate a patient and to access non-routine Acquisition Workstation options with no patient selected.
Page 67
Selenia User Guide Chapter 6—The User Interface 6.2.2 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.
Selenia User Guide Chapter 6—The User Interface Note You can use the asterisk (*) as a wildcard character to increase your search. For example, when you enter R*ph, Patients with the names Randolph and Rudolph will display. If you use a wildcard character, make sure that you include a minimum of one other character.
Selenia User Guide Chapter 6—The User Interface Verify the Patient Demographic Application Warning: information before you acquire an image. 6.2.4 How to Edit the Existing Patient Data Figure 39: The Edit Patient Dialog Box Note This procedure only changes the patient information for images in the case study not yet taken.
Selenia User Guide Chapter 6—The User Interface 6.2.5 New, Edit, Add a Procedure 6.2.5.1 How to Add a New Procedure Open an existing patient. Select New in the Procedure pane. Figure 40: New Procedure, Edit a Procedure, and Add a Procedure Buttons Select Yes in the Creating a New Procedure will close the current Procedure dialog box.
Page 71
Selenia User Guide Chapter 6—The User Interface 6.2.5.2 How to Edit a Procedure Select the Edit button in the Procedure area of the screen. Change the Accession Number. You cannot change the Procedure selection. Select the Accept button. 6.2.5.3 How to Add a Procedure The Add a Procedure function allows you to have many procedures open at the same time.
Page 72
Selenia User Guide Chapter 6—The User Interface 6.2.6 Image Output Figure 43: Select the Output Before acquiring an image, verify that you selected the correct output. All 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 73
Selenia User Guide Chapter 6—The User Interface 6.2.7 Exposure Information 6.2.7.1 The Exposure Pane Figure 44: Exposure Techniques The top, left side displays the status of these options: Compression Force Mode • Compression Release • Compression Thickness • Collimation Mode •...
Selenia User Guide Chapter 6—The User Interface 6.2.7.2 About Exposure Modes Table 7: Exposure Modes Exposure Operator Where the function is in the Techniques Pane Modes Adjustments (Item 1) Auto-Filter Select AEC Exposure Adjustment (item 2); AEC Sensor (item 3) (Positions 1-7 or Auto).
Page 75
Selenia User Guide Chapter 6—The User Interface 6.2.7.2.1 About the Manual Exposure Mode In the Manual mode the Operator sets all Exposure Techniques. The default values appear when you select the View, then you make any necessary adjustment. To change an Exposure Technique with the trackball, scroll to the value with the •...
Page 76
Selenia User Guide Chapter 6—The User Interface If you change one or more of the parameters (kV, mAs, or filter), the system enters the Override Mode. When the Override message displays, the system is ready to acquire an image. Figure 47: The Override Mode There are three methods to exit the Override Mode and return to TEC mode: Change the Breast Density setting.
Page 77
Selenia User Guide Chapter 6—The User Interface An increased exposure adjustment leads to a higher Warning: dose to the patient. Keep the patient dose as low as practical to get good image quality. Figure 48: AEC Exposure and Sensor Position Adjustments 6.2.7.2.5 AEC Sensor Position Indicator Settings...
Selenia User Guide Chapter 6—The User Interface 6.2.7.2.6 AEC Alarm Messages When the system cannot use the selected AEC mode to acquire an Image, one of the following messages displays. Table 8: AEC Alarm Messages Message Reason and Corrective Action Calculated Exposure The AEC Sensor is over a thin or small area of breast tissue.
Page 79
Selenia User Guide Chapter 6—The User Interface Table 9: Menu Bar Options and Functions Menu Options Function Manage Queues Find a specified job in the queue (Manage Queues on page 74). Eject Remove a disk from CD/DVD drive (Eject on page 75).
Page 80
Selenia User Guide Chapter 6—The User Interface 6.2.8.1 Edit Menu Function 6.2.8.1.1 Standard Setup Screens Figure 49: The Setup Screen Select Edit>Standard Setup. Use the trackball or the keyboard Tab key to move between fields. Use the trackball or arrow keys to display and select options.
Page 81
Selenia User Guide Chapter 6—The User Interface 6.2.8.1.3 View Order Editor Figure 50: View Order Editor Select Edit>View Order Editor. Select the procedure from the drop-down menus. Select the Views for each Procedure: Left click and hold on the View icon to move and change the order.
Selenia User Guide Chapter 6—The User Interface 6.2.8.1.4 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 51: The Edit Users Dialog Box...
Page 83
Selenia User Guide Chapter 6—The User Interface 6.2.8.1.5 Outputs To Add New Output Groups: Select Edit > Outputs. Select New. Enter the name for this Output. Select OK. Select the new name in the Edit Outputs dialog box. Select Edit.
Page 84
Selenia User Guide Chapter 6—The User Interface To Edit Outputs: Select Edit > Outputs. Select an Output name. If the Output keeps its current name, go to step 7. Select the Copy button. Enter a new Output name. Select the OK button.
Page 85
Selenia User Guide Chapter 6—The User Interface 6.2.8.2 Admin Menu 6.2.8.2.1 Image/Spool Management Select Admin>Image Management. The Choose a New Patient dialog box appears. Figure 53: Choose a New Patient Dialog Box Select the Patient Name tab or the Patient ID tab.
Page 86
Selenia User Guide Chapter 6—The User Interface Note To create more space on the hard disk drive, unprotect patients who do not need protection. To unprotect a patient record: Select the patient. Select the Unprotect button. 6.2.8.2.3 Manage Queues Use Manage Queues to find problem jobs or a specified job in the queues.
Selenia User Guide Chapter 6—The User Interface Table 11: How to Use Manage Queues Option Steps To find the status of In the Devices list, select the queue to view. • a job: Select the OK button. To delete a job: Select the queue in the Devices list.
Page 88
Selenia User Guide Chapter 6—The User Interface 6.2.8.2.4 Eject Select Admin>Eject to open the CD-RW drive drawer when there is a CD in the CD-RW drive. Note When the CD-RW drive is empty, press the button on the CD-RW drive to open the drawer.
Page 89
Selenia User Guide Chapter 6—The User Interface 6.2.8.2.6 The Resend Options Figure 55: Image Management Resend Options Select the Resend button. To resend all images on the hard disk drive for this patient, select Resend All • Images. To resend selected images, select the thumbnails of the images to resend, then •...
Page 90
Selenia User Guide Chapter 6—The User Interface 6.2.8.2.7 The Repreview Option Select the thumbnail image to review. Select the Repreview tab, then select the Repreview button. When you finish reviewing, select the Cancel button. To create a new file to resend, make any required changes to the markers, comments, or use the Edit View function, then click Save.
Page 91
6.2.8.2.11 Test Patterns Note See DICOM Printer Quality Control in the Selenia Quality Control Manual for more information about the SMPTE test pattern. Select Admin>Test Patterns. From the Output area of the screen: Select the Output Device from the drop-down list.
Page 92
Selenia User Guide Chapter 6—The User Interface 6.2.8.2.12 DR Device Control This function is for use by service personnel. 6.2.8.2.13 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
Selenia User Guide Chapter 6—The User Interface 6.2.8.3 Info Menu The Info menu displays the information about the Acquisition Workstation. 6.2.8.3.1 Gantry Serial Number and Detector Temperature To find the Gantry serial number: Select the Info tab. Select About the Acquisition Station.
Page 94
Selenia User Guide Chapter 6—The User Interface 6.2.9 Special Modes Buttons 6.2.9.1 Non-imaging Mode Button The Non-imaging mode is available to all users and allows the x-ray exposure without the acquisition of images. This mode is not available when you have a patient selected. When you select the Non-imaging mode, the Image Receptor deactivates.
Page 95
Selenia User Guide Chapter 6—The User Interface 6.2.12 Alarms Figure 58: The Alarm Icon Alarms are generally output problems that occur due to jobs that fail at the output device. The Alarm Icon shows the number of alarms. Select the icon to view the details. Erase the alarm to clear it.
Selenia User Guide Chapter 6—The User Interface Table 12: Actions on the Patient Views screen Topic Information Work with Views (item 1) Work with Views on page 84 Add/Edit the Patient Information How to Add a New Patient on page 56...
Page 97
Selenia User Guide Chapter 6—The User Interface 6.3.3 Acquire Images The system is ready to acquire images when the Generator Status indicates "Ready" (item 1 in the figure below), and the X through the x-ray symbol (item 2 in the figure below) in the Generator Status box is not displayed.
Page 98
Selenia User Guide Chapter 6—The User Interface Preview Image Screen 6.4.1 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 62: The Preview Image Screen...
Page 99
Selenia User Guide Chapter 6—The User Interface 6.4.2.2 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 100
Selenia User Guide Chapter 6—The User Interface 6.4.3 Tools for Image Enhancement and Annotation Figure Legend Comments Markers Edit View Implant Present Zoom/Pan Thumbnail Crosshair Measurement Window/Level ROI size Drop-down 10. Set Center/Width 11. Display AEC Regions 12. Exposure Index 13.
Page 101
Selenia User Guide Chapter 6—The User Interface 6.4.3.1 Comments The comment text is inserted in the DICOM header of the Acquired Image. The Diagnostic Review Workstation displays the comments. Figure 65: Image Comments Select the Comments button. Select the Additional Comment checkbox.
Page 102
Selenia User Guide Chapter 6—The User Interface 6.4.3.2 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. The tabs and buttons allow you to change just the Marker.
Page 103
Selenia User Guide Chapter 6—The User Interface Select the required view from the displayed list. Select Save. A new thumbnail image appears. Resend this image. 6.4.3.3 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.
Page 104
Selenia User Guide Chapter 6—The User Interface 6.4.3.5 Full Zoom/Pan Figure 67: Full Zoom/Pan Image The Full Zoom/Pan function becomes available after image processing is complete. The box in the thumbnail image on right side of the screen shows where the magnification view is in the complete image.
Page 105
Selenia User Guide Chapter 6—The User Interface 6.4.3.6 Figure 68: ROI Size Drop-down Menu Method 1: Draw a custom box. Method 2: Use a pre-defined box Select the ROI button. Select the ROI button. From the drop-down menu, select From the drop-down menu, User Draw.
Page 106
Selenia User Guide Chapter 6—The User Interface 6.4.3.7 Crosshairs Figure 69: Preview with Crosshairs Install a localization paddle. Acquire the image. If necessary, select the Zoom/Pan button and move through the image. Select the Crosshair button Select the area of interest in the image.
Page 107
Selenia User Guide Chapter 6—The User Interface 6.4.3.8 Measurement Figure 70: A Measurement on the Preview Screen Select the Measurement button Click the first point then drag to the second point. The distance displays when you release the button. Select the "+" at either end of the line to clear. There lines are not saved with the image.
Page 108
Selenia User Guide Chapter 6—The User Interface 6.4.3.9 Magnification Use the Magnification function to view part of the image at 2X the displayed resolution. Select the Magnification button. Move the box that appears at the area of interest. To turn off the magnification function, select the Magnification button a second time.
Page 109
Selenia User Guide Chapter 6—The User Interface 6.4.3.10 Window/Level Select the Window/Level button Select in the image and hold while you move the trackball. Roll Up or Down to change the brightness (Level). • Roll Right or Left to change the contrast (Window).
Page 110
Selenia User Guide Chapter 6—The User Interface 6.4.3.11 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
Selenia User Guide Chapter 6—The User Interface 6.4.3.12 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" shows that the image processing was applied.
Page 112
Selenia User Guide Chapter 6—The User Interface 6.4.4 Accept or Reject Select Accept or Reject to close the Preview screen. The sequence continues by highlighting the next view. 6.4.4.1 Accept To accept the image, select the Accept button. The full resolution image with all related attributes is marked as accepted in the pool.
Page 113
Selenia User Guide Chapter 6—The User Interface Select the Reject button. The system moves the image to the Reject Bin. An asterisk displays next to the View label of a rejected image. Figure 77: A Rejected Image 6.4.5 Additional information about Accepted/Rejected Images After you reject an image, the Preview closes and you can: Re-acquire the rejected View.
Page 114
Selenia User Guide Chapter 6—The User Interface 6.4.5.2 How to Accept a Rejected Image To accept a rejected image: Reject the image that was taken as the replacement for the rejected image. In the Patient View screen, select the Review button (below the Output box).
Selenia User Guide Chapter 6—The User Interface 6.4.5.3 How to Reject an Accepted Image To reject an Accepted Image: In the Patient View screen, select the Review button. In the dialog box, select the tab for the View to reject.
Page 116
Selenia User Guide Chapter 6—The User Interface Table 14: Workflow Suggestions to Select a Patient and Acquire an Image Action What it looks like Select the patient or add a new patient. You can select a patient by querying the MWL or by searching the local database.
Page 117
Select the patient from the patient list. b. Select Edit from the Patient area. Make the changes in the Edit Patient screen. d. Select the Accept button. Install the accessories. See The Selenia Face Shield • Accessories on page 43 for installation, Compression Paddle •...
Page 118
Selenia User Guide Chapter 6—The User Interface Table 14: Workflow Suggestions to Select a Patient and Acquire an Image Action What it looks like Select the view: Click Add View in the Patient View screen. b. In the dialog box, select a view from the list of Standard Mammography Views.
Page 119
Selenia User Guide Chapter 6—The User Interface Table 14: Workflow Suggestions to Select a Patient and Acquire an Image Action What it looks like Acquire the image: Make sure that the message area of the screen displays "Ready" (see item 1 in the following figure) and there is no "X"...
Page 121
Use the least possible amount of cleaning fluids. The Caution: fluids must not flow 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 •...
Page 122
Selenia User Guide Chapter 7—Maintenance and Cleaning 7.1.2 To Prevent Possible Injury or Equipment Damage Do not use a corrosive solvent, abrasive detergent, or polish. Select a cleaning/disinfecting agent that does not damage the plastics, aluminum, or carbon fiber. Do not use strong detergents, abrasive cleaners, high alcohol concentration, or methanol at any concentration.
Selenia User Guide Chapter 7—Maintenance and Cleaning 7.2.2 How to Clean the Keyboard Wipe the surfaces with a CRT wipe. If necessary, clean the keyboard with a vacuum. If liquids enter the keyboard, contact Technical Support for a replacement. Preventive Maintenance...
Page 125
Selenia User Guide Appendix A—System Specifications Appendix A System Specifications App endix A Dimensional Information A.1.1 Tubestand (Gantry with C-arm) Figure 81: Tubestand Dimensions A. Height with C-arm Travel 213.0 cm (84.07 inches) ±1.0 cm (0.4 inches) at highest C-arm...
Page 126
Selenia User Guide Appendix A—System Specifications A.1.3 Selenia Value Console Figure 83: Value Console Dimensions Height 191.3 cm (75.3 inches) Width 101.2 cm (39.8 inches) Depth 60.5 cm (23.8 inches) Weight 163.3 kg (360 lb) (maximum) Operating Environment A.2.1 General Operating Conditions Temperature Range 20 °C (68°...
Page 127
Selenia User Guide Appendix A—System Specifications Electrical Input A.4.1 Tubestand Mains Voltage 200/208/220/230/240 VAC nominal, true sinusoidal, (tap selectable at installation) ±10%, Single Phase, 50/60 Hz ± 5%, permanently wired Mains Impedance Maximum line impedance not to exceed 0.20 ohms for 220/230/240 VAC, 0.16 ohms for 200/208 VAC...
Page 128
Selenia User Guide Appendix A—System Specifications Tubestand Technical Information A.6.1 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.
Page 129
Selenia User Guide Appendix A—System Specifications Compression Down Motion Variable Speed Service Selectable between approximately 10% 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 130
Selenia User Guide Appendix A—System Specifications A.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.
Selenia User Guide Appendix A—System Specifications A.6.4.2 X-ray Beam Filtration and Output Inherent Tube Filtration 0.0 mm Al equivalent Added Filtration Two-position filter changer mechanism to carry a 60-micron (0.06 mm) Rhodium foil filter and a 60-micron (0.06 mm) Silver foil Filter. Type of filter is user selectable.
Selenia User Guide Appendix A—System Specifications A.6.7.1 kV /mA Range Table 17: LFS 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...
Page 133
Selenia User Guide Appendix A—System Specifications 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 134
Selenia User Guide Appendix A—System Specifications Imaging System Technical Information A.7.1 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 135
Selenia User Guide Appendix A—System Specifications Tissue Exposure Control (TEC) 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 136
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 requirements as...
Page 137
Selenia User Guide Appendix A—System Specifications A.10.2 Interface Connectivity DICOM 3.0 compatible Data port Ethernet Transfer rate Minimum: 10 Mbits/sec Look up Tables (LUT) Field programmable; Linear A.10.3 Printed Film Print to fit If a 24 x 29 cm image is printed on a 20 x 25 cm (8 x 10 inches)
Page 139
The Vertical Position Override Switch (VPOS) The Mobile Selenia has a Vertical Position Override Switch (VPOS) on the back of the Gantry. This switch can start the Selenia if the C-arm is lower than its normal operating position after rough-road travel.
Page 140
Selenia User Guide Appendix B—The Mobile Selenia The Vertical Position Override Switch is used to allow the operator to start the system and raise the C-arm to within its normal working limits. B.1.1.2 When to Use the VPOS This condition shows on the first startup after transport. The Acquisition Workstation starts normally, but the Gantry does not startup.
Page 141
Do not allow environmental conditions to exceed stated specifications when the unit is not in use. For permanent archive, the Selenia must be attached to a Caution: PACS system or connected to a suitable hard-copy printer when in use.
Page 142
Selenia User Guide Appendix B—The Mobile Selenia Mobile Specifications B.3.1 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 143
Selenia User Guide Appendix B—The Mobile Selenia How to Prepare the System for Transport Perform these steps before you transport the Mobile System: Rotate the C-arm to 0 degrees (CC position). Lower the C-arm to its lowest position. Remove all power from the system.
Selenia User Guide Appendix B—The Mobile Selenia How to Test the System Integrity After Transport Instructions: Photocopy this checklist for use after the system is relocated. Name_____________________________________ Date_______________ System Serial Number____________________________________ Table 20: Integrity Checklist Evaluated Control Functions Reference Mechanical System Tests...
Page 145
Selenia User Guide Index selecting in TEC • 63 Index button compression release • 25 Eject, on CD-RW drive • 76 on and x-ray • 25 accept button (software) image • 100 Accept • 56, 58, 100 rejected image • 102 Add View •...
Page 146
Selenia User Guide Index available space on • 80 compression release buttons • 25 ejecting disks • 76 handwheels • 29 importing images from • 76 light field lamp • 28, 33 location and appearance • 33 CD-RW Drive manual compression • 28 Eject button •...
Page 147
Selenia User Guide Index exam room door indicators • 13 exposure image display area • 86 changing mode resets exposure techniques • image enhancement and annotation tools • 88 Image Management duration • 13 Repreview • 78 information • 99 Resend •...
Page 148
Selenia User Guide Index international symbols • 7 specifications • 130 temperature/humidity control requirements • tests, pre/post transport • 131 job status, determine • 74 Vertical Position Override Switch (VPOS) • jobs in queue • 60, 83 127, 128 modality worklist provider, query • 55 monthly system tests •...
Page 149
Selenia User Guide Index post start-up tests • 33 Reject button • 100, 103 power failure • 9, 39 rejected image, asterisk • 100 Power On Remove Unexposed Views • 84 button • 25, 31 Repreview, using • 78 reprint images • 77 indicator light •...
Page 150
Selenia User Guide Index send test patterns • 79 accepted rejected images to outputs • 102 tests images to an output-post procedure • 77 after transport • 132 sensor position, AEC • 65 monthly system • 38 thumbnails • 102 Set Rejected button •...
Need help?
Do you have a question about the Selenia and is the answer not in the manual?
Questions and answers