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Hologic Faxitron Core User Manual
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Hologic Faxitron Core User Manual

Hologic Faxitron Core User Manual

Digital specimen radiography system
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User's Manual
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Document #: 04-1043-00
Version: 044
August 2021
Faxitron Core was previously known as CoreVision
FAXITRON CORE USERS MANUAL | HOLOGIC | REVISION 044

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Summary of Contents for Hologic Faxitron Core

  • Page 1 User’s Manual from Hologic ® Document #: 04-1043-00 Version: 044 August 2021 Faxitron Core was previously known as CoreVision FAXITRON CORE USERS MANUAL | HOLOGIC | REVISION 044...
  • Page 2 Read all this information carefully before operating the system. Follow all warnings and precautions as stated in this manual. Keep this manual available during procedures. Always follow all the instructions in this manual. Hologic, Inc. does not accept responsibility for injury or damage from incorrect system operation. Hologic, Inc. can arrange training at your site.
  • Page 3 Faxitron Core Specimen System Setup ............4-5 4.2.0 Moving the Faxitron Core Specimen System ............ 4-6 SECTION 5: Quick Start – Basic Operation of the Faxitron Core DR System ....5-1 5.0.0 Quick Start Overview ..................5-2 5.1.0 Power Up Sequence ..................5-3 5.1.1...
  • Page 4 Database Additional Options ................. 6-29 6.7.0 DICOM Functionality ..................6-33 6.8.0 User Annotations ....................6-40 6.9.0 About Help ......................6-43 6.10.0 About Faxitron Vision Software ................. 6-43 SECTION 7: Revision History Table ................... 7-1 FAXITRON CORE USERS MANUAL | HOLOGIC | REVISION 044...
  • Page 5 4 of this manual before continuing. Indications for Use The Faxitron Core Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.
  • Page 6 SECTION 1 User’s Manual Faxitron Core ® FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044...
  • Page 7 SECTION Introduction and Symbols This manual was created by Hologic, Inc. It is intended to guide the user on how to setup, install 1.0.0 and use the Faxitron Core hardware and Vision Software, both developed by Hologic, Inc. Introduction The user must first setup the hardware, then initiate the Vision Software. At a minimum, please review the required setup and safety procedures in this manual before attempting to operate the system.
  • Page 8 1.1.1 Symbol  Description  Warning and Caution Symbols Discard electrical and electronic equipment  on the Label separately from standard waste. Send  decommissioned material to Hologic or contact  your service representative.  Manufacturer  Date of Manufacture  Caution—Radiation (X‐Rays Produced)  Caution ‐ Potentially infectious materials  Warning Electricity  Caution  Follow or consult instructions for use  This system transmits radio frequency (RF) energy  (non‐ionizing radiation)  European Authorized Representative  Medical Device  Catalog number  Serial number    1 - 3 FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044...
  • Page 9 SECTION 2 Radiation Safety and X-Rays FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044...
  • Page 10 0.46 Radionuclides in the body (except radon) 0.23 Radon and its decay products TOTAL (rounded) *The elevated values are representative of large regions. Even higher values occur locally. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 2 - 2...
  • Page 11 Health effects of exposure to x-ray radiation come in two general types, direct or indirect. X- rays are thought to create radicals in exposed cells of your body that may break or modify chemical bonds within critical biological molecules. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 2 - 3...
  • Page 12 The utilization of appropriate radiation protection mechanisms and occupational exposure dose limits reduce the likelihood of these effects occurring. The occupational dose limits are far below the thresholds for deterministic effects. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 2 - 4...
  • Page 13 Additionally, the risk of cancer death is 0.08% per rem (10 mSv) for doses received rapidly (acute) and might be 2 times (0.04%, or 4 in 10,000) less than that for doses received over a long period of time (chronic). FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 2 - 5...
  • Page 14 An additional limit is needed for localised exposures in order to prevent tissue reactions. 2. Averaged over 1 cm2 area of skin regardless of the area exposed. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 2 - 6...
  • Page 15 The material used and thickness of the shied depends on the source of the radiation.  Lead is a common shielding material. Consult your Radiation Safety Officer for the rules and guidelines of specific to your facility. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 2 - 7...
  • Page 16 Shultis 2005: Shultis J K and Faw R E 2005 Radiation shielding technology Health Phys 88 297-322 Simpkin 1995: Simpkin D J 1995 Transmission Data for Shielding Diagnostic X-Ray Facilities Health Phys 68 704-709 FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 2 - 8...
  • Page 17 SECTION 3 About Your Faxitron Core System FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044...
  • Page 18 The Faxitron Core's small footprint allows it to be setup in surgical suites or offices with limited space. The Faxitron Core Digital Specimen Radiography System employs the use of Vision, a full featured and powerful image acquisition and data manipulation software. Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal.
  • Page 19 +1 800 264 073 All Other: +1 781 999 7750 Email: BreastHealth.Support@hologic.com Troubleshooting Refer to the Faxitron Core Technical Manual, contact your Hologic representative, or contact 3.0.3 Hologic Customer Service. Schedule of Maintenance SCHEDULE OF MAINTENANCE Refer to the Faxitron Core Technical Manual, contact your Hologic representative, or contact Hologic Customer Service.
  • Page 20 40 lbs (18 kg) POWER REQUIREMENTS: 120VAC 60Hz 150W Max or 230VAC 50Hz 150W Max HEAT OUTPUT: 500 BTU/hr Max X-RAY DUTY CYCLE: EXPOSURE CONTROL: Automatic or Manual FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 3 - 4...
  • Page 21 Safety Measures Emission Limits X-Ray Radiation emitted from the Faxitron Core unit does not exceed an exposure of 0.3 milli- Roentgens (mR) per hour at any point 5 centimeters (cm) outside the external surface. For countries requiring emission values measured at 10 cm from the external surfaces, the radiation does not exceed 0.1 mR per hour at 10 cm.
  • Page 22 No additional shielding is required. Attenuation The primary beam from the Faxitron Core X-ray tube is directed towards the floor of the system. Any reflected or scattered beams will be absorbed by the X-ray chamber top, walls, and drawer front.
  • Page 23 SECTION 4 Faxitron Core Installation and Set-up FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044...
  • Page 24 The camera system must never be mishandled, hit, knocked or dropped.  The Faxitron Core System has a calibration mode. Calibration must be completed daily to ensure proper system function. Refer to Sections 5 and 6 of this manual for the Calibration Procedure.
  • Page 25 Interoperable Connections 4.0.0 Cont. The Faxitron Core system is capable of operating as a standalone device without any input or output to other devices. Images can be captured, stored and reviewed directly on the system. However, the system does come with several interfaces. The primary interface is the network connection which allows the system to be connected to a Picture Archiving and Communication System (PACS).
  • Page 26 PACS or other closed-loop network. It is not intended to be connected to the internet unless, (a) the Facility is specifically instructed to do so by Hologic, or (b) the Facility takes adequate precautions to ensure the cybersecurity of the unit from threats related to its internet connection.
  • Page 27 Use caution when moving to prevent injury and damage to the system. Unpacking and Setting up the System The Faxitron Core system is to be unpacked and set up on site by a Hologic Inc. authorized representative. Location Leave at least 6”...
  • Page 28 X-RAY DUTY CYCLE: RADIATION SAFETY: Refer to Section 2 of this manual. 4.2.0 The Faxitron Core was designed as a stationary system to be set up on a desktop, countertop, Moving the or table. Faxitron Core Moving the Faxitron Core System - Not Recommended.
  • Page 29 SECTION 5 Quick Start and Basic Operation of the Faxitron Core System FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044...
  • Page 30  Choose or enter a patient in the Vision software and start an image acquisition from the software.  Press the Start (green) button on the Faxitron Core control panel or in the software. This will begin the X-ray exposure.
  • Page 31  Turn the computer and monitor “ON” and allow to fully boot into Windows.  Figure 5.1.1 Set the power switch on the back of the Faxitron Core cabinet to the Main Power Switch “ON” position. See Figure 5.1.1. ...
  • Page 32  The user will be given options to Select from Worklist, Manual Entry, Select from Database or Continue with current patient. See Figure 5.2.1. Figure 5.2.1 Patient Data Entry buttons FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 5 - 4...
  • Page 33 The user may complete other fields as desired. Note: The Date must be entered as yyyy/mm/dd (e.g. 1962/08/13).  Select Accept to enable image acquisition.  The system is ready to acquire images. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 5 - 5...
  • Page 34 On Screen “Start X-Ray” NOTE: Default X-ray mode for the Faxitron Core is Full Auto. The system will take two x-rays; the first to work out optimal settings and the second to take the image. The settings used during the exposures will be displayed on the cabinets LCD.
  • Page 35 SECTION 6 Vision Software Operation FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044...
  • Page 36 This start-up sequence must be followed to ensure proper system functionality and image quality:  Turn the Faxitron Core Cabinet power on using the switch on the back of the cabinet. (The power switch is next to the power cord receptacle). Depress “l” for “Power ON” and “0” for “Power OFF”.
  • Page 37 For convenience, Vision software combines the numerous steps of calibration, into a single unified step. When a Hologic X-Ray System has been turned off for longer than twelve (12) hours, the system will automatically request to re-calibrate. It is highly recommended that the system be re- calibrated, after extended periods of inactivity, or after the system is moved from one room to another room, with potentially different ambient temperature/humidity settings.
  • Page 38  When the X-Ray exposure is complete, click on the Estimate/Calculate button.  Record the calculated exposure time “Time [s]” reading.  Enter the calculated exposure time reading in the “Test Exposure” time box once again. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 4...
  • Page 39 Continue with Current Patient, Manual Entry, and Select from Database options will be accessible. The options are explained in the next sections. Figure 6.3.1 Patient Data Entry screen FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 5...
  • Page 40 Information Editor without having to press Submit. The Imaging Information Editor (Patient Information Dialog) will open. See Figure 6.3.3. Complete remaining required fields and click on Accept to proceed to image acquisition. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 6...
  • Page 41 6.3.3 Manual Entry Click on this button to manually enter a new Procedure. The "Imaging Information Editor" will open. See Figure 6.3.3. Follow the above procedure and notes. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 7...
  • Page 42 Vision allows the user to narrow the patient list by entering specific information in the “Search Parameters” window on the left side of the page. Only those patients matching all search parameters will be displayed. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 8...
  • Page 43 Once the user clicks on the Accept button the system is ready for image acquisition/x-rays. X-rays are started by pressing the green Start button on the front of the Faxitron Core cabinet or clicking on the Start X-Ray button in the lower right corner of the screen. See Section 5.2.2, Starting Exposure.
  • Page 44 Properties Dialog box will be displayed in the top-right corner of the image. The box is semi- transparent to allow one to see what’s underneath the box. See Figure 6.3.9. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 10...
  • Page 45 PACS PACS Save network. PACS Print Exposure Control (Device Control Panel) Back to Main Menu Shut System Down FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 11...
  • Page 46 The system will be idle (in Standby) during the processing, and once completed, the button will stay depressed/active. The user can undo the process, by pressing the button again. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 12...
  • Page 47 See Figure 6.4.3 (Informally this is also known as "Window Leveling."). An example of inverting is shown below: Figures 6.4.4 Example of inverting with the Window Level and Contrast tool FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 13...
  • Page 48 Figure 6.4.8 The button shown in Figure 6.4.8 will open the annotation tools. These tools and Annotations icon their many features are discussed in further detail in Section 6.8.0. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 14...
  • Page 49 The user can adjust each of these settings. Note that the mA setting in the Faxitron Core system is not adjustable via software and will always be inactive. When finished click on the Request X-Rays button to acquire an image, or the Set button to save the settings and close the Device Control Panel.
  • Page 50 The “View” Menu is located in the top Main Menu and contains the sub-menu items shown in Figure 6.4.17 below. Each of these options will be described in more detail in the following pages. Figure 6.4.17 View Menu FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 16...
  • Page 51 Zoom Mode Normal Displays the acquired image in its native format. The native format for the Faxitron Core image fits within the monitors display area. The user may zoom in on the image if desired. Refer to Dynamic Zoom Adjustment in Section 6.4.1.
  • Page 52 Processes current Patient image and enhances visualization of the tissue located near the periphery of the sample. Sample Viewer Sample View toggles a webcam viewer to aid specimen alignment. A webcam cannot be added to the Faxitron Core system. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 18...
  • Page 53 NOTE: Changing configuration parameters without proper knowledge or authorization can cause loss of image quality, system damage, and system malfunction. Service Mode “Service Mode” is password protected and turned on by Hologic authorized technicians for troubleshooting purposes. Service Tools “Service Tools” is normally greyed out. It is only turned on when the system is in “Service Mode”.
  • Page 54 6.2.0 and Figure 6.2.4 for a more detailed description. Preshot AEC Exposure Setup The Faxitron Core system utilizes Automatic Exposure Control (AEC) to provide the best possible image quality with a single press of the Start X-Ray button. The software utilizes a Preshot exposure to calculate the optimal exposure kV and time settings.
  • Page 55 The Login Utility is under the “Advanced Tools” menu and allows the user to configure and activate the start-up password authentication for Vision software. Activation of this feature is optional on the Faxitron Core system. If the user activates password authentication they will be prompted for the password each time the program is opened.
  • Page 56 The following features are available to edit the acquired or retrieved image by clicking on the “Image Tools” menu. See Figure 6.4.22. The sub-menu options are activated or accessed with a single mouse click on the desired option. Figure 6.4.22 Image Tools Menu FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 22...
  • Page 57 ROI. The contrast will automatically adjust to the best levels for that ROI. ROI Window Level The “ROI Window Level” function is not available in the current version of Vision software. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 23...
  • Page 58 Mean intensity values, and Standard Deviation (STD). To close the Statistics information box simply click on the Close button. See Figure 6.4.25. Click “ROI Statistics” again to turn off the feature. Figure 6.4.25 ROI Statistics FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 24...
  • Page 59 See Figure 6.4.27. By default, the averaging direction of the selected ROI is the short axis. The axis may be toggled back and forth by selecting the SWITCH, HOR<->VERT button. Click “ROI Profile” again to turn off the feature. Figure 6.4.27 ROI Profile FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 25...
  • Page 60 Click and hold the left mouse button over the displayed image and move the cursor up and down for brightness/darkness levels. Or, move the cursor left and right for low/high contrast. Move the cursor until image is at desired levels. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 26...
  • Page 61 There is also an option available to Open the Database (see Figure 6.5.3), which enters Review mode. This same button is the equivalent of pressing Review Mode, from the Home Menu. See Figure 6.0.1 and 6.6.1. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 27...
  • Page 62 The Database is basically comprised of three sections, or sub-windows. The Patient List Table section, at the top, the Procedure List Table section, in the middle, and the Image Thumbnail List/Viewer section, located at the bottom. Figure 6.6.2 Image Database FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 28...
  • Page 63 Those functions are explained through database menu items. They are accessed from the top-level button labelled Additional Figure 6.6.3 Options within the database. Additonal Options Menu FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 29...
  • Page 64 Search Filter is explained in detail under the Database Search subject below. Refresh DB Entries Refreshes the Patient table, but maintains any existing Search Filter that has been applied. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 30...
  • Page 65 Stop Search “Stop Search” disables any active Search Filter, clears all list tables, and re-loads the list of all Patients to Patient List Table FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 31...
  • Page 66  The top-left button will adjust itself to take the user Back to Acquisition, Back to the Main Menu, or will become the Close Database button dependent on the workflow used to enter the Database screen, and what is most appropriate. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 32...
  • Page 67 Application Profile or a specific implementation; the Prefix consists of 4 bytes, making up the character string "DICM" encoded as uppercase characters of the ISO 8859 G0 Character Repertoire; and the Data Elements are arbitrarily large (or small) and contain the data. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 33...
  • Page 68 DICOM File Settings. These settings (Storage Type & Modality, Transfer Syntax, and Value Representation) will be effective for all DICOM Local Save or Print functionalities. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 34...
  • Page 69 DICOM Networking Dialog window can be displayed. This Dialog box allows the user to do Figure 6.7.5 DICOM Store, DICOM Networking Dialog box DICOM Print, or to Add, Modify Remove DICOM Network connections or Peripherals. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 35...
  • Page 70 A list also follows: Figure 6.7.6 Session Properties Dialog box A GENERAL DICOM / PACS Connection A DICOM STORE Connection A DICOM PRINTER Connection A DICOM Modality WORKLIST Connection FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 36...
  • Page 71 Add Session button. A confirmation of action will be requested, see below. Figure 6.7.7 Verifying Removal of an Existing DICOM Network Connection FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 37...
  • Page 72 To accept the modified configuration, select OK. To reject the options and exit the window without making any changes, select Cancel. Figure 6.7.9 Set DICOM PRINT FILM Attributes FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 38...
  • Page 73 DICOM command was executed. This command also closes the connection or association, between the Vision software and the remote DICOM device, if a connection was established. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 39...
  • Page 74 "permanent" or final position. Figure 6.8.2 User Annotation Design Tool Pallet Starting from the upper-left of the above figure a description follows of each tool option. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 40...
  • Page 75 14. Protractor Tool: Draws an angle on screen and provides the degree of the angle. Just like a protractor. 15. Orthogonal Ruler Tool: Provides two (2) ruled lines that are at right angles to each other. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 41...
  • Page 76 By default, the annotations will be toggled on. The User Annotations button is located in the right-side menu, near the upper right corner. FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044 6 - 42...
  • Page 77 Vision Software The “Help” menu, see Figure 6.9.1, is located on the top menu bar and provides quick access 6.9.0 to the Faxitron Core “User’s Manual” and “About Vision”. Refer to Figure 6.10.1. Help Figure 6.9.1 Help Menu The “About Vision” submenu opens a Dialog box, that shows the Vision software version, 6.10.0...
  • Page 78 Pg 65 Corrected errors in Sequence Protocol 07-07-2016 Alan Mihalko Mikhail Viznyuk Pg 90 Corrected Figure reference from 6.9 to 6.5.1 in Section 6.5.0 Pg 98 Deleted extra ‘period’ from Figure FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044...
  • Page 79 Added “Consult IFU” symbol and “package-inserts” web address/link Added AU Sponsor and Brazilian August Contact Information See CCB Alan Mihalko 2021 Added Table for “Warning and Caution Symbols on the Label” Updated Service Contact Information FAXITRON CORE USER MANUAL | HOLOGIC | REVISION 044...
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