Faxitron CT User Guide Rev 004 July 2021

Technical Support USA:

+1.877.371.4372

Europe:

+32 2 711 4690

Asia:

+852 37487700

Australia:

+1 800 264 073

All Other:

+1 781 999 7750

Email:

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© 2021 Hologic, Inc. Printed in the USA. This manual was originally written in English. Hologic, Faxitron, and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners. This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patents

Faxitron CT Specimen Radiography System User Guide Table of Contents

Table of Contents List of Figures _________________________________________________________________ ix List of Tables _________________________________________________________________xiii 1: Introduction __________________________________________________________________1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12

Intended Use... 1 System Capabilities... 1 User Profiles... 2 Quality Control Requirements ... 2 Where to Find the Installation Instructions ... 2 Where to Find Technical Description Information ... 2 Warranty Statement ... 2 Technical Support ... 2 Product Complaints ... 3 Hologic Cybersecurity Statement ... 3 Symbols ... 4 Descriptions of Warnings, Cautions, and Notes ... 5

2: General Information___________________________________________________________7 2.1 2.2

2.3 2.4 2.5

2.6 2.7 2.8 2.9

System Overview ... 7 Safety Information ... 8 2.2.1 Radiation Safety and Emissions Limits ... 8 2.2.2 Interlocks ... 8 Warnings and Precautions ... 8 Interlock Operation... 13 Compliance ... 14 2.5.1 Compliance Requirements ... 14 2.5.2 Compliance Statements ... 15 DICOM Standard ... 16 Interoperable Connections... 17 Network / User Settings ... 18 Label Locations ... 19

3: Components, Controls, and Indicators __________________________________________25 3.1 3.2 3.3 3.4

System Components ... 25 3.1.1 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 4.1

System Start-Up ... 29

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4.2 4.3

4.4 4.5

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 5.1 5.2 5.3

Image Calibration... 39 Geometric Calibration ... 41 Uniformity Calibration ... 42

6: Faxitron CT Software Operation _______________________________________________45 6.1 6.2 6.3 6.4

Software Overview ... 45 Software Start-Up... 45 Calibration ... 45 Patient Data ... 46 6.4.1 Select from Work List (Modality Work List) ... 46 6.4.2 Continue with Current Patient ... 48 6.4.3 Manual Entry... 48 6.4.4 Select from Database ... 49 6.5 Image Acquisition ... 49 6.5.1 Image Screen - 2D Mode ... 50 6.5.2 Image Screen – 3D Mode ... 51 6.6 Left Tool Bar/Image Tools ... 52 6.6.1 Set/Edit Patient Data ... 53 6.6.2 Enhance Image ... 54 6.6.3 Window Level ... 54 6.6.4 Image Zoom... 56 6.6.5 Annotations ... 57 6.6.6 Save Image data to PACS (Save) ... 60 6.6.7 Back to Main Menu... 61 6.7 Right Tool Bar ... 61 6.7.1 Show/Hide Image Info (Image Properties) ... 61 6.7.2 Show/Hide Image Annotations ... 62 6.7.3 Save Snapshot... 62 6.8 3D Images... 63 6.8.1 Specimen Orientation ... 64 6.8.2 Slice Views ... 69 6.8.3 MIP View ... 70 6.8.4 Hounsfield Units ... 71 6.9 Current Patient Image History ... 73 6.10 Review ... 73 6.11 DICOM / PACS Functionality ... 75 6.12 Settings ... 76

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6.13 About ... 78 6.14 Help ... 79

7: Quality Control ______________________________________________________________81 7.1 7.2

7.3

Required Quality Control Procedures ... 81 Service and Troubleshooting ... 81 7.2.1 Service ... 81 7.2.2 Troubleshooting ... 81 Cybersecurity ... 82

8: Maintenance, Cleaning, and Disinfecting _______________________________________83 8.1

8.2

8.3

General Information ... 83 8.1.1 For General Cleaning ... 83 8.1.2 For Disinfecting... 83 8.1.3 To Prevent Possible Injury or Equipment Damage ... 84 Component Specific Care ... 84 8.2.1 How to Clean the Image Display Monitor ... 84 8.2.2 Power Cord... 85 Maintenance ... 85 8.3.1 Preventive Maintenance Schedules ... 85

Appendix A System Specifications _______________________________________________87 A.1 A.2

A.3

Product Measurements ... 87 Operation and Storage Environment ... 88 A.2.1 General Conditions for Operation... 88 A.2.2 General Conditions for Transport and Storage ... 88 Technical Specification ... 89 A.3.1 System Specifications ... 89 A.3.2 X-Ray CMOS Detector ... 89 A.3.3 Object to Imager and Source to Object Distance Chart ... 90 A.3.4 X-ray Tube Technical Information ... 91 A.3.5 Computer Specifications ... 91

Glossary of Terms ______________________________________________________________93

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List of Figures Figure 1: Faxitron CT System ... 7 Figure 2: “Motion Error” and “Radiography Scan Cancelled” Error Messages ... 13 Figure 3: “CT Scan Cancelled” Error Message ... 14 Figure 4: Label Locations - Front ... 19 Figure 5: Label Locations - Back ... 20 Figure 6: Labels A1, A2, D1, D2 & E from P/N 7120-6300 Label Set ... 21 Figure 7: Labels C, F, K & O from P/N 7120-6300 Label Set and ... 22 Labels C & E from P/N 05-0260-04 Label Set ... 22 Figure 8: Compliance and Identification Label, 120VAC, 2 required ... 23 Figure 9: System Components ... 25 Figure 10: X-Ray/Imaging Chamber... 26 Figure 11: Power and Network Connections ... 27 Figure 12: Faxitron CT ... 29 Figure 13: Password Authentication Dialog ... 29 Figure 14: Calibrate Button ... 30 Figure 15: Calibration Menu ... 30 Figure 16: Start Image Calibration ... 31 Figure 17: Calibration Progress Window ... 31 Figure 18: Faxitron CT Consumable Tray ... 32 Figure 19: Specimen Orientation ... 32 Figure 20: Home Menu ... 33 Figure 21: Start Procedure Menu ... 33 Figure 22: Patient Information Editor ... 34 Figure 23: 2D Mode Selected ... 34 Figure 24: 2D Image Screen ... 35 Figure 25: 3D Mode Selected ... 35 Figure 26: 3D Image Screen ... 36 Figure 27: “CT Scan Cancelled” Error Message ... 36 Figure 28: PACS Store Button ... 37 Figure 29: SENDING TO PACS Status Bar ... 37 Figure 30: Shut Down Button – Home Menu... 37 Figure 31: Confirm Shutdown Dialog ... 38 Figure 32: Calibrate Button ... 39 Figure 33: Calibration Menu ... 40 Figure 34: Start Image Calibration ... 40 Figure 35: Calibration Progress Window ... 40 Figure 36: Geometric Calibration Instruction Dialog... 41 Figure 37: Start Geometric Calibration ... 42 Figure 38: Uniformity Calibration Instruction Dialog ... 42 Figure 39: Image Display Screen... 43 Figure 40: Faxitron Software, Home Menu ... 45 Figure 41: Start Procedure Menu ... 46 5081-9544 Revision 004

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Figure 42: Modality Work List Dialog ... 46 Figure 43: Admin Screen ... 47 Figure 44: Patient Information Editor ... 48 Figure 45: Selecting Patient from Local Database Entries ... 49 Figure 46: Start X-Ray Button ... 49 Figure 47: 2D Image Screen ... 50 Figure 48: 3D Image Screen ... 51 Figure 49: “CT Scan Cancelled” Error Message... 51 Figure 50: Left Side Tool Bar ... 52 Figure 51: Patient Information Viewer – Image Acquisition and Review Modes... 53 Figure 52: Image Enhancement Button ... 54 Figure 53: Adjust Image Contrast Button ... 54 Figure 54: Adjust Image Contrast Tool ... 55 Figure 55: Adjust Image Zoom Button ... 56 Figure 56: Zoom Level Tool ... 56 Figure 57: Access Image Annotations Tools Button ... 57 Figure 58: Annotations Tools ... 57 Figure 59: Annotation Examples... 58 Figure 60: Text Tool with Text Editor Dialog ... 59 Figure 61: Text Tool Color Palette ... 59 Figure 62: All Annotation Tools/Objects Selected ... 60 Figure 63: PACS Store Button ... 60 Figure 64: Sending to PACS Status Bar ... 60 Figure 65: Back to Main Menu Button ... 61 Figure 66: Right Tool Bar ... 61 Figure 67: Show/Hide Image Info Button ... 61 Figure 68: Image Properties from Image Acquisition Screen ... 61 Figure 69: Image Properties from Review Screen... 61 Figure 70: Show/Hide Image Annotations Button ... 62 Figure 71: Save Snapshot Button ... 62 Figure 72: Save A Snapshot Dialog... 62 Figure 73: Save Snapshot File Types ... 63 Figure 74: Faxitron CT (3D) Display ... 63 Figure 75: Play Button ... 64 Figure 76: Faxitron CT 3D View ... 64 Figure 77: Specimen Orientation ... 65 Figure 78: Faxitron CT 3D Display ... 65 Figure 79: CC View ... 66 Figure 80: LM/ML View ... 66 Figure 81: AP View ... 67 Figure 82: 3D Rendered View ... 67 Figure 83: Orientation Marker Button ... 68 Figure 84: Faxitron CT Orientation Markers ... 68 Figure 85: Faxitron CT Slice View ... 69 Figure 86: Faxitron CT Slice View ... 69

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Figure 87: Faxitron CT Slice Views ... 70 Figure 88: Faxitron CT MIP and Slice Views ... 71 Figure 89: Hounsfield Units – Fatty Tissue ... 72 Figure 90: Hounsfield Units – Denser Fibrous Tissue ... 72 Figure 91: Hounsfield Units - Calcification ... 73 Figure 92: Image History Button ... 73 Figure 93: Image History Thumbnail Strip ... 73 Figure 94: Review Mode Button in the Home Menu ... 73 Figure 95: Review Page ... 74 Figure 96: Viewer (Review Screen)... 74 Figure 97: Browser Button ... 75 Figure 98: Browser File System Button ... 75 Figure 99: Home Menu ... 75 Figure 100: DICOM Settings... 76 Figure 101: Viewer Settings ... 77 Figure 102: Imager Parameters ... 77 Figure 103: Home Menu ... 78 Figure 104: About Faxitron CT – System Information ... 78 Figure 105: Help Menu... 79 Figure 106: Cabinet Measurements ... 87 Figure 107: Source to Imager and Object to Imager Dimensions ... 90

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List of Tables Table 1: Required Procedures ... 81 Table 2: User Preventive Maintenance... 85 Table 3: Service Preventive Maintenance ... 85

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Faxitron CT Specimen Radiography System User Guide Chapter 1: Introduction

Chapter 1 Introduction 1:

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. Physicians should tell patients about all potential risks and adverse events described in this manual with respect to the operation of the system. Note Hologic configures some systems to meet specific requirements. Your system configuration may not have all the options and accessories included in this manual.

1.1

Intended Use United States federal law restricts this device to use by, or on the order of, a physician. The Faxitron® CT is a Cabinet x-ray system that is used to provide two and threedimensional digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.

1.2

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; the system is not intended for diagnostic purposes. Specimen radiography systems are used in diagnostic imaging departments, pathology departments, or in surgical suites. Radiologic Technologists, surgical personnel, surgeons, radiologists, and pathologists can use specimen radiography equipment. Hologic recommends that users receive training in basic ionizing radiation safety before using the system.

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Faxitron CT Specimen Radiography System User Guide Chapter 1: Introduction

1.3

1.4

User Profiles •

The Faxitron CT system does not utilize multiple User Profiles. There is a single login to the system software.

•

Service personnel have full access to all system functions.

Quality Control Requirements Perform all Quality Control tests within the correct time frame.

1.5

Where to Find the Installation Instructions Installation instructions are available in the Service Manual.

1.6

Where to Find Technical Description Information Technical description information is available in the Service Manual.

1.7

Warranty Statement Except as otherwise expressly stated in the Agreement: i) Equipment manufactured by Hologic is warranted to the original Customer to perform substantially in accordance with published product specifications for one (1) year starting from the date of shipment, or if Installation is required, from the date of Installation (“Warranty Period”); ii) digital imaging mammography x-ray tubes are warranted for twenty-four (24) months, during which the x-ray tubes are fully warranted for the first twelve (12) months and are warranted on a straight-line prorated basis during months 13-24; iii) replacement parts and remanufactured items are warranted for the remainder of the Warranty Period or ninety (90) days from shipment, whichever is longer; iv) consumable Supplies are warranted to conform to published specifications for a period ending on the expiration date shown on their respective packages; v) licensed Software is warranted to operate in accordance with published specifications; vi) Services are warranted to be supplied in a workman-like manner; vii) non-Hologic Manufactured Equipment is warranted through its manufacturer and such manufacturer’s warranties shall extend to Hologic’s customers, to the extent permitted by the manufacturer of such non-Hologic Manufactured Equipment. Hologic does not warrant that use of Products will be uninterrupted or error-free, or that Products will operate with non-Hologic authorized third-party products. These warranties do not apply to any item that is: (a) repaired, moved, or altered other than by Hologic authorized service personnel; (b) subjected to physical (including thermal or electrical) abuse, stress, or misuse; (c) stored, maintained, or operated in any manner inconsistent with applicable Hologic specifications or instructions, including Customer’s refusal to allow Hologic recommended Software upgrades; or (d) designated as supplied subject to a non-Hologic warranty or on a pre-release or “as-is” basis.

1.8

Technical Support Refer to the copyright page of this manual for contact information for product support.

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1.9

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. When necessary, Hologic provides the updates to the product. For Cybersecurity Best Practices documents for Hologic products, refer to the Hologic Internet site at www.Hologic.com.

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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. Manufacturer

Date of Manufacture

or

Caution-Radiation (X-Rays Produced)

Caution - Potentially infectious materials

Warning Electricity

Caution

or

Follow or consult instructions for use This system transmits radio frequency (RF) energy (nonionizing radiation) European Authorized Representative Medical Device Catalog number Serial number

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1.12

Descriptions of Warnings, Cautions, and Notes Descriptions of Warnings, Cautions, and Notes used in this manual:

WARNING! The procedures that you must follow accurately to prevent possible dangerous or fatal injury. Warning: The procedures that you must follow accurately to prevent injury. 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. Warning: Warns the reader to use appropriate protection, such as gloves or an approved specimen container, to avoid exposure to potentially infectious materials such as patient tissue samples. Caution: The procedures that you must follow accurately to prevent damage to equipment, loss of data, or damage to files in software applications. Note Notes show additional information.

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Faxitron CT Specimen Radiography System User Guide Chapter 2: General Information

Chapter 2 General Information 2:

2.1

System Overview

Figure 1: Faxitron CT System Figure Legend 1. Control Panel/Touchscreen 2. X-ray Imaging Chamber 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.

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2.2

Safety Information Read and understand this manual before you use the system. Keep the manual available during the operation of the unit. 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.

2.2.1

2.2.2

Radiation Safety and Emissions Limits • •

Radiation shielded cabinet.

•

Radiation: Less then 0.1 mR/hr at any point 5 cm (2 in.) from exterior surface at maximum kV. For countries requiring emission values measured at 10 cm from external surfaces, the radiation does not exceed 1.0 μS/hr at 10 cm.

•

Certified to comply with standards set by the US Food and Drug Administration, Center for Devices and Radiological Health, (21 CFR 1020.40).

X-Ray chamber door equipped with dual safety interlocks. See Sections 2.2.2 and 2.4 of this Manual.

Interlocks The Faxitron CT system has two independent safety interlocks on the chamber door. Opening the door will immediately terminate x-ray generation.

2.3

Warnings and Precautions WARNING! Only trained Service Engineers authorized through Hologic can open any of the panels. This system contains lethal voltages. WARNING! Electrical equipment used near flammable anesthetics can cause an explosion. WARNING! The user must correct problems before the system is used. Contact an approved service representative for preventive maintenance.

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WARNING! 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. WARNING! Do not attempt to use any console that could present a shock hazard. Immediately contact Hologic or your distributor. WARNING! To prevent shock hazard, do not use the system unless the blades of the polarized plug can be fully inserted in the electrical outlet. WARNING! Before each use, check that the power cord is in good condition and is fully inserted in the electrical outlet. WARNING! Make sure that the power cord for the system console is in good condition. A damaged power cord can be an electrical shock hazard. When disconnecting the console from power, always grasp the plug at the insertion point and pull lightly. NEVER pull on the cord to unplug the unit. WARNING! Before moving the console, make sure that the power cord and any cables are unplugged and wrapped securely around the cord management plate.

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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. Warning: This device contains dangerous material. Send decommissioned material to Hologic or contact your service representative. Warning: Control the access to the equipment according to local regulations for radiation protection. Warning: Do not use the system if the glass is cracked or damaged. Warning: This system can be dangerous to the user. Always follow the safety precautions for x-ray exposures. Warning: Cables and cords can pose a tripping hazard. Position cords safely out of the way. When not in use, wind cords securely around the cord management plate. Warning: Before moving the console, make sure the caster locks are unlocked. Trying to move the system with the casters locked can cause the console to tip over. Warning: Before moving the system, rotate the Image Display monitor to a position that provides clear visibility while pushing the console. Warning: Do not move the console with excessive force or speed. Do not make quick stops.

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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. Warning: Keep the Imaging Cabinet door closed when not in use. Leaving the door open can pose a tripping hazard. Warning: Use the Imaging Cabinet door handle to open and close the door. Closing the Imaging Cabinet door incorrectly can cause a pinch hazard. Caution Risk of data loss. Do not put any magnetic media near or on devices that create any magnetic fields. Caution To prevent possible damage from thermal shock to the Digital Image Receptor, follow the recommended procedure to turn off the equipment. Caution Use the least possible amount of cleaning fluids. The fluids must not flow or run. Caution To prevent damage to the electronic components, do not use disinfectant sprays on the system. Caution To prevent damage to the console and its components, use only the recommended cleaning methods. Caution Do not spill or put fluids or liquids on the touch screen or the touch pad. Fluids or liquids on the touch screen and the touch pad can cause a malfunction. Make sure that the touch screen and touch pad are clean and dry before using the system.

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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. The computer virus protection or network security for this laboratory device is not provided (for example, a computer firewall). The network security and anti-virus provisions are the responsibility of the user. Caution To prevent possible damage to the system, follow the recommended procedure to turn off the equipment. Caution The system must be installed and put into service according to the guidance provided in these instructions to ensure its electromagnetic compatibility. Caution Portable and mobile RF communications can affect medical electrical equipment. Caution To prevent low image quality, perform system calibrations when prompted. Caution To prevent low image quality, make sure to remove all patient material from the Imaging Cabinet and specimen tray. Use the recommended cleaning methods to clean and disinfect the Imaging Cabinet and specimen tray. Caution To prevent damage, use care when handling and cleaning the specimen tray. Caution The weight and mobility of this system require the following precautions:

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•

Be careful when you move the system on uneven or sloped surfaces.

•

Make sure the wheels are locked when the system is stationary.

•

Before you move the console, make sure the cables are stored in a safe position on the console.

•

Before you move the console, rotate the Image Display screen to allow for an unobstructed view.

•

Do not make quick stops. Do not move with excessive force or speed.

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