Hologic Trident HD User manual

Trident
®
HD
Specimen Radiography System
User Guide
For Software Version 1.0
Part Number MAN-05478-002
Revision 003
August 2018

© 2018 Hologic, Inc. Printed in the USA. This manual was originally written in English.
Hologic, Trident, 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
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All Other: [phone]
Email: [e-mail]

Trident HD Specimen Radiography System User Guide
Table of Contents
MAN-05478-002 Revision 003 v
Table of Contents
List of Figures _________________________________________________________________ ix
List of Tables __________________________________________________________________ xi
1: Introduction __________________________________________________________________1
1.1 Intended Use............................................................................................................................................................1
1.2 System Capabilities.................................................................................................................................................1
1.3 User Profiles.............................................................................................................................................................1
1.4 Quality Control Requirements..............................................................................................................................2
1.5 Where to Find the Installation Instructions......................................................................................................... 2
1.6 Where to Find Technical Description Information.............................................................................................2
1.7 Warranty Statement................................................................................................................................................2
1.8 Technical Support ...................................................................................................................................................2
1.9 Product Complaints................................................................................................................................................ 2
1.10 Hologic Cybersecurity Statement .........................................................................................................................3
1.11 Symbols .................................................................................................................................................................... 3
1.12 Descriptions of Warnings, Cautions, and Notes ................................................................................................4
2: General Information___________________________________________________________5
2.1 System Overview....................................................................................................................................................5
2.2 Safety Information .................................................................................................................................................. 6
2.3 Warnings and Precautions..................................................................................................................................... 6
2.4 Interlocks................................................................................................................................................................ 10
2.5 Compliance............................................................................................................................................................ 11
2.5.1 Compliance Requirements .................................................................................................................... 11
2.5.2 Compliance Statements .........................................................................................................................12
2.6 Label Locations .....................................................................................................................................................13
3: Components, Controls, and Indicators __________________________________________15
3.1 System Components ............................................................................................................................................. 15
3.1.1 Imaging Cabinet Components.............................................................................................................. 16
3.2 System Connections..............................................................................................................................................18
3.3 How to Lock and Unlock a Caster...................................................................................................................... 18
3.4 How to Move the Console ................................................................................................................................... 19
3.5 How to Turn On the System and Log In ...........................................................................................................19
3.5.1 Windows 10 Information....................................................................................................................... 21
3.6 How to Log Out .................................................................................................................................................... 22
3.7 How to Turn Off the System ...............................................................................................................................22
3.7.1 How to Remove All Power from the System......................................................................................22

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4: User Interface________________________________________________________________23
4.1 About the Taskbar.................................................................................................................................................23
4.2 Select Patient Screen .............................................................................................................................................25
4.2.1 Open a Patient .........................................................................................................................................26
4.2.2 Add a New Patient .................................................................................................................................26
4.2.3 Edit the Patient Information..................................................................................................................27
4.2.4 Split the Patient Records........................................................................................................................28
4.2.5 Delete a Patient .......................................................................................................................................31
4.2.6 Filters for Patients...................................................................................................................................31
4.2.7 How to Refresh the Worklist.................................................................................................................33
4.2.8 How to Query the Worklist...................................................................................................................33
4.2.9 Admin ......................................................................................................................................................33
4.2.10 Close the Patient List..............................................................................................................................33
4.3 Procedure Screen...................................................................................................................................................34
4.3.1 Add a Procedure.....................................................................................................................................35
4.3.2 Simple and Advanced Button ...............................................................................................................36
4.3.3 Retrieve ....................................................................................................................................................36
4.3.4 Close a Patient.........................................................................................................................................37
4.3.5 How to Select an Output Group...........................................................................................................37
4.4 How to Access Image Review Features .............................................................................................................37
4.5 How to Use the Output Groups..........................................................................................................................37
4.5.1 Add or Edit an Output Group ..............................................................................................................37
4.6 How to Use the On-Demand Outputs ...............................................................................................................38
4.6.1 How to Archive.......................................................................................................................................38
4.6.2 How to Export.........................................................................................................................................38
4.6.3 Print ..........................................................................................................................................................39
5: The Images __________________________________________________________________41
5.1 Image Display Screen ...........................................................................................................................................41
5.2 How to Set the Exposure Techniques.................................................................................................................42
5.3 How to Acquire an Image....................................................................................................................................42
5.4 How to Review the Images..................................................................................................................................45
5.4.1 Image Review Tools ...............................................................................................................................46
5.5 Send the Images to the Output Devices.............................................................................................................49
6: Sample Clinical Sequences____________________________________________________51
6.1 Example Imaging Workflow ...............................................................................................................................51
6.2 Example Sequence of Operation .........................................................................................................................52
7: Quality Control ______________________________________________________________59
7.1 Required Quality Control Procedures ...............................................................................................................59
7.2 How to Access the Quality Control Tasks.........................................................................................................59
7.2.1 Gain Calibration......................................................................................................................................60

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8: Maintenance, Cleaning, and Disinfecting _______________________________________61
8.1 General Information ............................................................................................................................................. 61
8.1.1For General Cleaning .............................................................................................................................61
8.1.2 For Disinfecting.......................................................................................................................................61
8.1.3 To Prevent Possible Injury or Equipment Damage............................................................................62
8.2 Component Specific Care .................................................................................................................................... 62
8.2.1 How to Clean the Image Display Monitor.......................................................................................... 62
8.2.2 Power Cord..............................................................................................................................................63
8.3 Maintenance .......................................................................................................................................................... 63
8.3.1 Preventive Maintenance Schedules......................................................................................................63
8.3.2 About Reclamation................................................................................................................................. 64
9: System Administration Interface_______________________________________________65
9.1 Admin Screen ........................................................................................................................................................65
9.2 About Screen ......................................................................................................................................................... 67
9.3 Change the User Language Preference..............................................................................................................68
9.4 Set Multi Line Procedure Tabs............................................................................................................................68
9.5 System Tools.......................................................................................................................................................... 69
9.5.1 System Tools for the Radiologic Technologist Manager................................................................... 69
9.6 Archive Tool .......................................................................................................................................................... 70
9.7 How to Change the Default Lock Out Time .....................................................................................................72
Appendix A: System Specifications ______________________________________________73
A.1 Product Measurements ........................................................................................................................................ 73
A.2 Operation and Storage Environment ................................................................................................................. 74
A.2.1 General Conditions for Operation........................................................................................................ 74
A.2.2 General Conditions for Transport and Storage .................................................................................. 74
A.3 Console Technical Information ...........................................................................................................................75
A.3.1 General Information............................................................................................................................... 75
A.3.2 Network Environment........................................................................................................................... 75
A.4Electrical Input ......................................................................................................................................................75
A.5 X-ray Tube Technical Information......................................................................................................................76
A.5.1 X-Ray Generator ..................................................................................................................................... 76
A.6 Imaging System Technical Information.............................................................................................................76
A.6.1 Image Receptor ....................................................................................................................................... 76
Appendix B: System Messages and Alerts_________________________________________77
B.1 Error Recovery and Troubleshooting................................................................................................................. 77
B.2 Types of Messages and Alert messages .............................................................................................................77
B.2.1 Fault Levels ............................................................................................................................................. 77
B.2.2 System Messages .................................................................................................................................... 78
B.3 Troubleshooting....................................................................................................................................................78

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Glossary of Terms______________________________________________________________79
Index _________________________________________________________________________81

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List of Figures
Figure 1: Trident HD System ...........................................................................................................................................5
Figure 2: Label Locations................................................................................................................................................13
Figure 3: System Components .......................................................................................................................................15
Figure 4: Specimen Tray Positions ................................................................................................................................16
Figure 5: Specimen Tray Markings for the Full-Field Detector.................................................................................17
Figure 6: Power and Network Connections.................................................................................................................18
Figure 7: System Power Switch......................................................................................................................................19
Figure 8: Computer Power Switch ................................................................................................................................20
Figure 9: Login Screen.....................................................................................................................................................20
Figure 10: Startup Screen................................................................................................................................................21
Figure 11: The Taskbar....................................................................................................................................................23
Figure 12: Select Patient Screen......................................................................................................................................25
Figure 13: Add Patient Screens ......................................................................................................................................26
Figure 14: Edit Patient Information Screens.................................................................................................................27
Figure 15: Split Patient Records Screen ........................................................................................................................28
Figure 16: Select the Correct Procedure to Split Patient Records..............................................................................29
Figure 17: Select the Correct Patient to Split Patient Records....................................................................................30
Figure 18: Filter Tab in the Patient Filter Screen..........................................................................................................31
Figure 19: Procedure Screen...........................................................................................................................................34
Figure 20: Add Procedure Dialog Box ..........................................................................................................................35
Figure 21: Tools Tab, Simple ..........................................................................................................................................36
Figure 22: Tools Tab, Advanced ....................................................................................................................................36
Figure 23: Print Screen ....................................................................................................................................................40
Figure 24: Image Display Screen....................................................................................................................................41
Figure 25: Imaging Enabled ...........................................................................................................................................42
Figure 26: X-RAY Button ................................................................................................................................................43
Figure 27: X-RAY Button while the Exposure Is in Progress.....................................................................................43
Figure 28: Tools Tab in the Procedure Screen..............................................................................................................45
Figure 29: The Image Review Tools ..............................................................................................................................46
Figure 30: The Comments Tab .......................................................................................................................................47
Figure 31: Priors Tab .......................................................................................................................................................48
Figure 32: Display Modes...............................................................................................................................................48
Figure 33: Admin Screen.................................................................................................................................................65
Figure 34: System Tab of the About Screen..................................................................................................................67
Figure 35: System Tools Button .....................................................................................................................................69
Figure 36: System Tools Screen......................................................................................................................................69
Figure 37: Archive Button...............................................................................................................................................70
Figure 38: Multi Patient On Demand Archive Screen ................................................................................................71
Figure 39: Export Screen .................................................................................................................................................72
Figure 40: Console Measurements.................................................................................................................................73

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List of Tables
Table 1: System Labels ....................................................................................................................................................14
Table 2: The Taskbar Sections ........................................................................................................................................23
Table 3: Filter Tab Options (Require Access Privileges)..........................................................................................32
Table 4: The Procedure Screen .......................................................................................................................................34
Table 5: Required Procedures ........................................................................................................................................59
Table 6: User Preventive Maintenance..........................................................................................................................63
Table 7: Service Preventive Maintenance .....................................................................................................................64
Table 8: Admin Screen Functions ..................................................................................................................................65
Table 9: Radiologic Technologist Manager—System Tools Functions.....................................................................70

Trident HD Specimen Radiography System User Guide
Chapter 1: Introduction
MAN-05478-002 Revision 003 Page 1
1: Introduction
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 Trident®specimen radiography system is a cabinet x-ray system used to provide
digital x-ray images of surgical and core biopsy specimens from various anatomical
regions in order to allow rapid verification that the correct tissue has been excised during
the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow,
thus reducing the time the patient needs to be under examination.
1.2 System Capabilities
The Trident system acquires and displays the radiographic images of surgical and core
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.
1.3 User Profiles
•A Primary System User (for example, an operating room nurse) can perform basic
system functions, except ones that require Manager privileges. The Primary System
User is referred to in this document as the User.
•System Managers can perform all system functions, add and delete user accounts, and
delete patients. The System Manager is referred to in this document as the Manager.
•Service personnel have full access to all system functions.
Chapter 1

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Chapter 1: Introduction
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1.4 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.
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.

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Chapter 1: Introduction
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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.
1.11 Symbols
This section describes the Symbols on this system.
Symbol
Description
"ON" for part of the equipment
Potential Equalization terminal
Discard electrical and electronic equipment separately from standard
waste. Send decommissioned material to Hologic or contact your service
representative.
Manufacturer
Date of Manufacture
Caution—Radiation
Warning Electricity
Caution
Follow instructions for use
This system transmits radio frequency (RF) energy (non-ionizing
radiation)
Catalog number
Serial number

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Chapter 1: Introduction
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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.
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.

Trident HD Specimen Radiography System User Guide
Chapter 2: General Information
MAN-05478-002 Revision 003 Page 5
2: General Information
2.1 System Overview
Figure 1: Trident HD System
Figure Legend
1. Image Display Monitor
2. Control Display
3. Imaging Cabinet
Chapter 2

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Chapter 2: General Information
Page 6 MAN-05478-002 Revision 003
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.
2.3 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.
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 Trident 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.

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Chapter 2: General Information
MAN-05478-002 Revision 003 Page 7
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.
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.

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Chapter 2: General Information
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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.
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.