X-Ray/Imaging Chamber Components ....................26 System Connections .............................. 27 How to Lock and Unlock a Caster ........................28 How to Move the Console ........................... 28 4: Quick Start – Basic Operation of the Faxitron CT ________________________________29 System Start-Up ..............................29 5081-9544 Revision 004...
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Faxitron CT Specimen Radiography System User Guide Table of Contents Calibration ................................30 Basic Imaging Procedure ............................. 31 4.3.1 Enter Patient Data ........................... 33 4.3.2 Acquire Images ............................34 Saving Images to PACS ............................37 Shutdown Procedure ............................37 5: Calibration __________________________________________________________________39 Image Calibration..............................
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Faxitron CT Specimen Radiography System User Guide Table of Contents 6.13 About ..................................78 6.14 Help ..................................79 7: Quality Control ______________________________________________________________81 Required Quality Control Procedures ....................... 81 Service and Troubleshooting ..........................81 7.2.1 Service ..............................81 7.2.2 Troubleshooting ............................81 Cybersecurity ................................
Faxitron CT Specimen Radiography System User Guide Table of Contents List of Tables Table 1: Required Procedures ............................81 Table 2: User Preventive Maintenance.......................... 85 Table 3: Service Preventive Maintenance ........................85 5081-9544 Revision 004 xiii...
System Capabilities The Faxitron CT system acquires and displays 2D and 3D radiographic images of surgical specimens taken from various anatomical regions. The system has the capability to transfer the images to external devices. The images acquired with this system are intended to confirm removal of a suspected lesion or pathology;...
Faxitron CT Specimen Radiography System User Guide Chapter 1: Introduction User Profiles • The Faxitron CT system does not utilize multiple User Profiles. There is a single log- in to the system software. • Service personnel have full access to all system functions.
Chapter 1: Introduction Product Complaints Report any complaints or problems in the quality, reliability, safety, or performance of this product to Hologic. If the device has caused or added to patient injury, immediately report the incident to Hologic. 1.10 Hologic Cybersecurity Statement Hologic continuously tests the current state of computer and network security to examine possible security problems.
Faxitron CT Specimen Radiography System User Guide Chapter 1: Introduction 1.11 Symbols This section describes the Symbols on this system. Symbol Description Discard electrical and electronic equipment separately from standard waste. Send decommissioned material to Hologic or contact your service representative.
Warning: Warns the reader that ionized radiation is emitted into the labeled area when the x-ray beam is energized. The Faxitron CT system has safety interlocks to prevent the labeled area from being accessed while the x-ray beam is energized.
3. Image Display Monitor 4. Keyboard & Trackball The Faxitron CT system reconstructs excised specimens in real-time. CT is designed to help achieve better surgical outcomes and improve intraoperative specimen margin assessment by providing a full 3D reconstruction of the specimen with 0.1mm slices in the X, Y, and Z-Axes.
Always follow all the instructions in this manual. Hologic does not accept responsibility for injury or damage from incorrect system operation. Hologic can arrange for training at your site. The system has safety interlocks, but the user must understand how to safely operate the system and be aware of the health hazards of x-ray radiation.
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The protection provided by the equipment is reduced if the equipment is used in a method not specified by Hologic. WARNING! Always place the Faxitron CT system a minimum of 1.5 meters (5 feet) from the patient. WARNING! No modification of this equipment is allowed.
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Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information WARNING! Before adjusting the position of the console, make sure the power cord and any cables are safely positioned out of the way. WARNING! To prevent fire or shock hazard, do not expose the system to rain or moisture.
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Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Warning: When moving the console, be aware of bumps, ramps, inclines, or declines. Use extra caution when moving the console on an uneven or sloped surface. Warning: Make sure there is adequate space to completely open the Imaging Cabinet door and to safely insert or remove the specimen tray.
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Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Caution: The system is a laboratory device and not a normal computer. Do not make changes to the hardware or software that are not authorized. Install this device behind a firewall for network security.
Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Interlock Operation X-ray generation stops automatically whenever the Interlock system is interrupted. The Interlock system may be interrupted due to user action, i.e., opening the chamber door, or a fault in the system, such as a failed switch or a fault in the Interlock system wiring.
Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Figure 3: “CT Scan Cancelled” Error Message The system will revert to “Standby” whenever the door is opened during x-ray generation. Click the Okay button in each error message, Close and/or verify the chamber door is fully closed, The system should now be “Ready”...
If adjacent or stacked use is necessary, make sure that the ME Equipment or ME System operates correctly in this configuration. Caution: Changes or modifications not expressly approved by Hologic could void your authority to operate the equipment. 2.5.2...
• NEMA PS3 / ISO 12052, Digital Imaging and Communications in Medicine (DICOM) Standard, National Electrical Manufacturers Association, Rosslyn, VA, USA (available free at http://www.dicomstandard.org/) • See Faxitron CT DICOM Conformance Statement for more information. Page 16 5081-9544 Revision 004...
Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Interoperable Connections The Faxitron CT 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.
Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Network / User Settings The detector on the Faxitron CT uses an ethernet (network) connection to communicate. Adding users or setting additional network security can prevent the detector from communicating to the software.
Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Label Locations Figure 4: Label Locations - Front 5081-9544 Revision 004 Page 19...
Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information NOTE: Labels C and E are from P/N 05-0260-04, Label Set, BioVision Figure 5: Label Locations - Back Page 20 5081-9544 Revision 004...
Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Figure 6: Labels A1, A2, D1, D2 & E from P/N 7120-6300 Label Set 5081-9544 Revision 004 Page 21...
Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Figure 7: Labels C, F, K & O from P/N 7120-6300 Label Set and Labels C & E from P/N 05-0260-04 Label Set Page 22 5081-9544 Revision 004...
Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information Figure 8: Compliance and Identification Label, 120VAC, 2 required 5081-9544 Revision 004 Page 23...
Faxitron CT Specimen Radiography System User Guide Chapter 3: Components, Controls, and Indicators 3.1.1 X-Ray/Imaging Chamber Components The console houses a shielded imaging cabinet. The placement of the specimen tray determines the magnification level of the image. Figure 10: X-Ray/Imaging Chamber Figure Legend 1.
Faxitron CT Specimen Radiography System User Guide Chapter 3: Components, Controls, and Indicators System Connections Power and Network Connections Figure Legend 1. System Power Switch 2. Power Cord Connection 3. Computer Reset Button 4. Ethernet Port Figure 11: Power and Network Connections Put the system in a location where you can easily access power connections and network connections.
Faxitron CT Specimen Radiography System User Guide Chapter 3: Components, Controls, and Indicators How to Lock and Unlock a Caster • To lock a caster, step on the locking lever on the wheel until the lever locks. • To unlock a caster, press forward on the top of the locking lever until the lever snaps to the UP position.
Quick Start – Basic Operation of the Faxitron System Start-Up Caution: The Faxitron CT has a battery back-up which allows the system to be moved without powering down. However, the system must be on mains power when capturing images, including during calibration.
Note During operation the touch screen on the Faxitron CT control panel will show the status at the top of the screen. For example – Calibrating, Stand-by, and Ready. Calibration Note This section provides a summary of Image Calibration only.
Faxitron CT Specimen Radiography System User Guide Chapter 4: Quick Start – Basic Operation of the Faxitron CT Ensure the chamber is empty, including the foam tray, check the box to confirm the chamber is empty, then click the Start button.
Faxitron CT Specimen Radiography System User Guide Chapter 4: Quick Start – Basic Operation of the Faxitron CT Place the specimen in a Faxitron CT Specimen Tray. The specimen must fit completely within the inner ring shown below. (10 trays were provided with your system.)
Faxitron CT Specimen Radiography System User Guide Chapter 4: Quick Start – Basic Operation of the Faxitron CT 4.3.1 Enter Patient Data Click the Start Procedure button in the Home Menu. Figure 20: Home Menu This will open the Start Procedure Menu, which provides options to Select from Work List, if configured, Continue with Current Patient, if there is a previous patient used, Manual Entry, or Select from Database.
4.3.2 Acquire Images Caution: To ensure optimum image quality do not touch the Faxitron CT system during either 2D or 3D image acquisition. The CT system has 2 modes – 2D imaging and 3D imaging. The system defaults to 2D mode as shown below.
Faxitron CT Specimen Radiography System User Guide Chapter 4: Quick Start – Basic Operation of the Faxitron CT When the exposure is complete the computer will process the data and after a few seconds display two orthogonal images. Figure 24: 2D Image Screen...
Faxitron CT Specimen Radiography System User Guide Chapter 4: Quick Start – Basic Operation of the Faxitron CT When the exposure and processing are complete a four-pane view is displayed. Figure 26: 3D Image Screen When a CT scan is canceled for any reason, i.e., door is opened, the Stop...
Faxitron CT Specimen Radiography System User Guide Chapter 4: Quick Start – Basic Operation of the Faxitron CT Saving Images to PACS 2D and 3D (CT) image series can be sent to the PACS network for storage, assuming a PACS connection has been configured, by clicking the PACS Store button in the left tool bar.
If the system has been knocked or moved over an uneven floor, all 3 calibrations should be performed to maintain the image quality. Caution: The Faxitron CT has a battery back-up which allows the system to be moved without powering down. However, the system must be on mains power when capturing images, including during calibration.
Faxitron CT Specimen Radiography System User Guide Chapter 5: Calibration Figure 33: Calibration Menu Ensure the chamber is empty, including the foam tray, check the box to confirm the chamber is empty, then click the Start button. Figure 34: Start Image Calibration A Calibration Progress Window will open, and the system will begin Image Calibration.
Faxitron CT Specimen Radiography System User Guide Chapter 5: Calibration window, press the physical Stop button on the system control panel, or press the Stop button in the control panel touch screen. Geometric Calibration Geometric Calibration ensures the system is set up correctly to perform the highly precise reconstruction of the CT images (3D).
Faxitron CT Specimen Radiography System User Guide Chapter 5: Calibration Place the Geometric Calibration Phantom on the pedestal then click the Okay button in the dialog. The Start Geometric Calibration Dialog will open. Figure 37: Start Geometric Calibration Check the box to confirm the Phantom is placed then click the Start button.
Faxitron CT Specimen Radiography System User Guide Chapter 5: Calibration Uniformity Calibration utilizes a clear Uniformity Calibration Phantom. The bottom of the phantom has a flat cut into it which matches the recess in the CT pedestal. This recess ensures the phantom is properly positioned and prevents it from shifting during calibration.
Figure 40: Faxitron Software, Home Menu Software Start-Up See Chapter 4, Quick Start – Basic Operation of the Faxitron CT, for software start-up procedure. Note A password is required to enter the software and initiate X-Rays.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation Patient Data The Start Procedure button takes the user to the Patient Data Entry Menu which provides methods to enter patient data. If a Work List has been configured correctly, the button will be green.
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation On the left are various filters that may be used to search for scheduled procedures. Enter a search parameter into the field(s) and select the Query button located in the bottom left corner.
6.4.3 Manual Entry See Chapter 4, Quick Start – Basic Operation of the Faxitron CT System for details. Click on the Manual Entry button to enter a Patient’s details manually. The Patient Information Editor will open. Complete all required fields and click the Accept button.
To ensure optimum image quality do not touch the Faxitron CT system during either 2D or 3D image acquisition. See Chapter 4, Quick Start – Basic Operation of the Faxitron CT, for information on how to place the specimen into the system and acquire an image.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation 6.5.1 Image Screen - 2D Mode After an image is acquired in 2D mode two orthogonal images will appear on the screen as shown below. Orthogonal images are two images taken at right angle to each other. For example, if the sample is placed correctly the left image will be Latero-Medial (LM) for the left breast and Medio-Lateral (ML) for the right breast.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation 6.5.2 Image Screen – 3D Mode After an image is acquired in 3D mode four images will appear on the screen as shown below. The bottom right image is a 3D rendering of the reconstruction volume. All other views are reconstructed slice views of the specimen.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation The following sections outline the manipulation of the images. Left Tool Bar/Image Tools The software provides various tools to control various image attributes or parameters, x- ray acquisition, image views, image tools, and DICOM settings/access. The most commonly used tools are in a Tool Bar.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation the tool allows it to be dragged anywhere in the image window. When undocked the pin Icon turns into an “X” which can be clicked to close the tool. Clicking the “X” also locks the tool into the location it was left in.
6.6.3 Window Level The Faxitron CT Software provides 2 methods for adjusting the brightness and contrast of the image: The Window Level tool, accessed through the Left Side Tool Bar, and a “Built-in Windowing Tool” feature. Both are described below.
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation Window Level (brightness) is adjusted by moving the center bar up to increase brightness or down to decrease brightness. Window Width (contrast) is adjusted by dragging the end bars up or down. The end bars move together to either decrease or increase the Window Width.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation 6.6.4 Image Zoom Clicking on the Adjust Image Zoom button in the Left Side Tool Bar opens the Zoom Level Tool. Figure 55: Adjust Image Zoom Button...
6.6.5 Annotations User Annotations in the Faxitron CT Software allows the user to apply a graphic “overlay” commonly called “annotations” to an image. These annotations take the form of text, lines, “free form” lines, arrows, ellipse, and boxes. This allows additional information and “markers”...
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation All the Annotation Tools, except as noted, are drawn with “Click-Move-Click” mouse movements. i.e., Click at the starting point, move the mouse, click at the end point.
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation Note In 2D Mode all annotations will be blue. In 3D Mode All annotations will be the color of the square in the lower left corner of the image pane, i.e., red, blue, or yellow.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation The following figure shows all annotation tools selected. Note the end points (or handles), center points, and the nodes in the Polygon Open Line Tool (the Ampersand).
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation 6.6.7 Back to Main Menu The Back button exists the Image Acquisition or Review Mode and returns to the Home Menu. Figure 65: Back to Main Menu Button...
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation 6.7.2 Show/Hide Image Annotations The Show/Hide Image Annotations button allows the user to easily toggle annotations on or off. This button does not delete the annotations from the image.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation The screen shot can be saved in any of the file types shown below: Figure 73: Save Snapshot File Types 3D Images The 3D View is divided into 4 images, which are described later in this section.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation Each of the 4 views can be maximized to full screen by clicking the square button in the top right corner of the window. The circular arrow button in the bottom right is the view reset button, which will reposition the specimen back to its original view.
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation Figure 77: Specimen Orientation This will produce the image shown below. Figure 78: Faxitron CT 3D Display Note The orientation only applies to specimens that are placed on the foam correctly.
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation Note The anatomical positions for the following views are referenced with the scroll bar in each view moving from left to right as when the Play button in that view has been pressed.
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation View 3, lower left quadrant, is Posterior Anterior (PA). Figure 81: AP View View 4, lower right, is the 3D Rendered View. Figure 82: 3D Rendered View The colored faces of the Cube in the 3D view correspond to the squares in the corner of the other 3 views.
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation This coloring of the Cube is similar to how specimens are linked to show their orientation. Orientation Markers can be displayed in each view to aid the user in associating each slice view to the precise anatomical direction.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation 6.8.2 Slice Views The bottom right image is a reconstructed 3D view of the specimen. The other 3 views show the reconstructed specimen slices in each of the main axis.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation For example, as the scroll bar goes left the Red line on the other view moves down indicating the position of the slice. Figure 87: Faxitron CT Slice Views 6.8.3...
Figure 88: Faxitron CT MIP and Slice Views To switch between MIP and SLICE view simply click on the word in the bottom left corner.
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation The Hounsfield unit is a quantitative scale for describing radiosensitivity relative to water, defined as 0, and air, defined as -1000. It is frequently used in CT scans. Simply place the cursor over the area you want to measure.
Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation Figure 91: Hounsfield Units - Calcification Current Patient Image History Previous images captured during a procedure may be reviewed by clicking the History button at the bottom of the screen.
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Faxitron CT Specimen Radiography System User Guide Chapter 6: Faxitron CT Software Operation Figure 95: Review Page Note that the system is in standby while in Review mode. When the Review page is first opened only the Patient List will be populated. The lower part of the screen will be empty.
DICOM / PACS Functionality DICOM Services Configuration All images on the Faxitron CT are saved and transmitted to PACS in DICOM format. To connect the system to a PACS server click on the settings page from the home screen. Figure 99: Home Menu Then select the DICOM tab.
• Institution Name, Institution Address, Station Name: Information included in DICOM images. • Station AE Title: Identification of Faxitron CT in DICOM Store and DICOM Modality Worklist communications. DICOM Store Settings • Breast Specimen SOP Class, 2D: Images of breast tissue specimens can be transferred in Digital Mammography X-Ray Image Storage –...
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These settings affect the image panes or views. Figure 101: Viewer Settings Directories The settings to define the Default Directories are only available to authorized Hologic Service Personnel. Imager Parameters The 2 settings available to the user are the comm port settings for the x-ray subsystem and pedestal movement.
About Figure 103: Home Menu Clicking About from the Home Menu will open an information window shown below. The About window provides software version and imager information. Figure 104: About Faxitron CT – System Information Page 78 5081-9544 Revision 004...
• View a short animation demonstrating the proper Specimen Placement, • • Get the contact information for help in using your system, The Support button provides information on contacting Hologic’s technical support • team and • Exit to Windows. 5081-9544 Revision 004...
Section 5.3 Service and Troubleshooting 7.2.1 Service There are no serviceable parts in the Faxitron CT. Refer to the copyright page at the front of this manual. 7.2.2 Troubleshooting The following are a few issues that you may be able to solve with some basic troubleshooting steps.
Faxitron CT Specimen Radiography System User Guide Chapter 7: Quality Control Cybersecurity If a cybersecurity event occurs disconnect the system from the network and contact Faxitron immediately. We will work with your IT department to resolve the issue. A cybersecurity event can be detected in a number of ways: •...
Use the least possible amount of cleaning fluids. The fluids must not flow or run. 8.1.2 For Disinfecting To disinfect the system's components and surfaces, Hologic recommends the following disinfecting solutions: • 10% chlorine bleach solution and water with one part commercially available chlorine bleach solution (normally 5.25% chlorine and 94.75% water) and nine...
Faxitron CT Specimen Radiography System User Guide Chapter 8: Maintenance, Cleaning, and Disinfecting 8.1.3 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.
Power Cord How to Inspect the Power Cord Once every quarter, visually inspect the power cord for cuts, damage to the cover, or strain relief. If the power cord appears damaged, contact Hologic for replacement of the power cord. Maintenance 8.3.1...
Faxitron CT Specimen Radiography System User Guide Appendix A: System Specifications System Specifications Appendix A Appendix A Product Measurements Figure 106: Cabinet Measurements Height 180 cm (70 inches) Width 70 cm (27 inches) Depth 65 cm (25 inches) Weight 140 kg (315 pounds) 290 kg (640 pounds) –...
Faxitron CT Specimen Radiography System User Guide Appendix A: System Specifications Operation and Storage Environment A.2.1 General Conditions for Operation This equipment is designed for safe and effective operation under the following conditions for Indoor Use: Altitude To 2,000 m (5,562 feet)
Faxitron CT Specimen Radiography System User Guide Appendix A: System Specifications Technical Specification A.3.1 System Specifications Spatial Resolution 100μm or better Source to Imager Distance (SID) 14.4” (36.6cm) Exposure Control Fully Automatic (or fixed) Geometric Magnification 1.2X to 4.0X (Automatically optimized depending on specimen size)
Faxitron CT Specimen Radiography System User Guide Appendix A: System Specifications A.3.3 Object to Imager and Source to Object Distance Chart Mag Position. Factor cm (inches) cm (inches) 25.1 (9.9”) 1.8 (4.5”) 14.0 (5.5”) 3.5 (8.9”) 10.2 (4.0") 4.1 (10.4") See Figure on next page.
Faxitron CT Specimen Radiography System User Guide Appendix A: System Specifications A.3.4 X-ray Tube Technical Information Hologic P/N: 130-552025 Manufacturer P/N: MF90150 (Oxford Instruments) Max Anode Voltage 50 kV Max Anode Current* 1.0 mA Maximum Power 12W continuous (Isowatt limited to 11.5W max) Focal Spot Size <15 um...
Faxitron CT Specimen Radiography System User Guide Glossary of Terms Glossary of Terms Object to Imager Distance Automatic Exposure Control Region of Interest Annotations Markings on an image to indicate an area of Source to Image Distance interest. Superior Anterior Above, over, toward the head/upper part of a In front of, at or near the front of the body.
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