Hologic Trident User manual

ENG-0034-T33, Rev. 002
TITLE DOCUMENT NUMBER REV
AW, MNL, TRIDENT
USER GUIDE AW-05673 008
ARTWORK SIZE A SHEET 1 OF 1
REV AUTHORED BY DATE
J. SHARP 12/31/14
REV DRAFTED BY DATE
J. SHARP 12/31/14
PROPRIETARY INFORMATION:
The content of this document is the
exclusive property of Hologic and may
not, without prior written permission of
Hologic, be reproduced, copied or used
for any purpose whatsoever.
Artwork and Signature File for:
MAN-02098 “MNL, TRIDENT, USER GUIDE”
Artwork consists of:
Seventy-Four (74) 8 ½ inch x11 inch sheets attached.

User Guide
For Software Version 1.1
Part Number MAN-02098
Revision 008
December 2014

Trident User Guide
Table of Contents
MAN-02098 Revision 008 v
Table of Contents
List of Figures _________________________________________________________________ ix
List of Tables __________________________________________________________________ xi
1: Introduction __________________________________________________________________1
1.1 Intended Use............................................................................................................................................................1
1.2 Intended Use for the User Guide..........................................................................................................................1
1.3 System Capabilities.................................................................................................................................................1
1.4 Product Complaints................................................................................................................................................1
1.5 Technical Support ................................................................................................................................................... 1
1.6 Hologic Cybersecurity Statement .........................................................................................................................2
1.7 Installation Instructions .........................................................................................................................................2
1.8 Users .........................................................................................................................................................................2
1.9 Terms and Definitions............................................................................................................................................2
1.10 International Symbols ............................................................................................................................................3
1.11 Warnings, Cautions, and Notes ............................................................................................................................3
2: General Information___________________________________________________________5
2.1 System Description ................................................................................................................................................. 5
2.2 Safety Information ..................................................................................................................................................6
2.3 Warnings and Cautions .........................................................................................................................................6
2.4 Interlocks..................................................................................................................................................................8
2.5 Compliance..............................................................................................................................................................9
2.5.1 Compliance Requirements.......................................................................................................................... 9
2.5.2 Compliance Statements...............................................................................................................................9
2.6Label Locations .....................................................................................................................................................10
3: Components, Controls, and Indicators __________________________________________11
3.1 Shielded Cabinet Components............................................................................................................................ 11
3.2 Workstation Components....................................................................................................................................12
3.3 Cart Components.................................................................................................................................................. 12
3.3.1 How to Lock a Caster ................................................................................................................................ 13
3.3.2 How to Move the Cart............................................................................................................................... 13
3.4 Controls and Indicators........................................................................................................................................ 13
3.4.1 Cabinet Controls and Indicators .............................................................................................................. 13
3.4.2 Display Controls and Indicators.............................................................................................................. 14
3.5 Cable Connections ................................................................................................................................................14
3.6 How to Start the System ...................................................................................................................................... 15
3.6.1 Log In........................................................................................................................................................... 16
3.7 How to Shutdown the System ............................................................................................................................ 17
3.7.1 How to Remove All Power from the System .........................................................................................17
3.8 Battery Power Operation ..................................................................................................................................... 18

Trident User Guide
Table of Contents
vi MAN-02098 Revision 008
3.8.1 Battery Alerts..............................................................................................................................................18
3.8.2 How to Stop the Beep from the UPS .......................................................................................................18
4: The User Interface____________________________________________________________19
4.1 The Select Patient Screen......................................................................................................................................19
4.1.1 How to Open a Procedure ........................................................................................................................20
4.1.2 How to Add a New Patient ......................................................................................................................20
4.1.3 How to Edit the Patient Information.......................................................................................................21
4.1.4 How to Delete a Patient.............................................................................................................................21
4.1.5 The Patient Filter Screen............................................................................................................................22
4.1.6 How to Refresh the Worklist ....................................................................................................................23
4.1.7 How to Query the Worklist ......................................................................................................................23
4.2 The Procedure Screen...........................................................................................................................................24
4.2.1 How to Select a Procedure........................................................................................................................24
4.2.2 How to Set the Exposure Techniques......................................................................................................25
4.2.3 How to Acquire an Image.........................................................................................................................25
4.2.4 How to Add a Procedure ..........................................................................................................................26
4.2.5 How to Close a Procedure ........................................................................................................................26
4.3 How to Access Image Review Features .............................................................................................................26
4.4 How to Use the Output Groups..........................................................................................................................26
4.4.1 How to Select an Output Group ..............................................................................................................26
4.4.2 How to Add or Edit an Output Group ...................................................................................................27
4.5 How to Use the On-Demand Outputs ...............................................................................................................27
4.5.1 How to Archive ..........................................................................................................................................27
4.5.2 How to Print ...............................................................................................................................................28
4.5.3 How to Export ............................................................................................................................................29
4.6 About the Taskbar.................................................................................................................................................30
4.7 How to Set Up the Specimen Cabinet ................................................................................................................31
4.8 How to Do the Gain Calibration .........................................................................................................................32
5: The Images __________________________________________________________________33
5.1 Introduction ...........................................................................................................................................................33
5.1.1 Information on the Left Side of the Image..............................................................................................33
5.1.2 Information on the Right Side of the Image ...........................................................................................34
5.2 How to Review the Images..................................................................................................................................34
5.2.1 Image Review Tools...................................................................................................................................36
5.3 Send the Images to the Output Devices.............................................................................................................40
6: Clinical Procedures___________________________________________________________41
6.1 System Startup.......................................................................................................................................................41
6.2 Image Acquisition.................................................................................................................................................41
6.3 System Shutdown .................................................................................................................................................42

Trident User Guide
Table of Contents
MAN-02098 Revision 008 vii
7: System Administration Interface_______________________________________________43
7.1 How to Use the Admin Screen............................................................................................................................ 43
7.2 How to Use the System Tools ............................................................................................................................. 45
7.2.1 The System Tools Screen........................................................................................................................... 46
8: Maintenance, Cleaning, and Disinfecting _______________________________________47
8.1 General Information .............................................................................................................................................47
8.1.1 For General Cleaning.................................................................................................................................47
8.1.2 For Disinfecting.......................................................................................................................................... 47
8.1.3 To Prevent Possible Injury or Equipment Damage............................................................................... 48
8.2 Workstation ........................................................................................................................................................... 48
8.2.1 How to Clean the Display......................................................................................................................... 48
8.2.2 How to Remove the Keyboard Cover (if Equipped).............................................................................49
8.2.3 How to Clean Keyboard Cover (if Equipped) .......................................................................................50
8.2.4 How to Clean the Keyboard ..................................................................................................................... 50
8.3 Preventive Maintenance Schedule...................................................................................................................... 51
Appendix A: System Specifications ______________________________________________53
A.1 Shielded Cabinet, Workstation, and Cart.......................................................................................................... 53
A.2 Operation and Storage Environment ................................................................................................................. 53
A.2.1 General Conditions for Operation........................................................................................................... 53
A.2.2 Storage Environment................................................................................................................................. 53
A.3 Workstation Technical Information ................................................................................................................... 54
A.3.1 General Information .................................................................................................................................. 54
A.3.2 Network Environment ..............................................................................................................................54
A.4Electrical Input ......................................................................................................................................................54
A.5 X-ray Tube Technical Information...................................................................................................................... 54
A.5.1 X-Ray Generator......................................................................................................................................... 54
A.6 Imaging System Technical Information............................................................................................................. 55
A.6.1 Image Receptor........................................................................................................................................... 55
Appendix B: System Messages and Alerts_________________________________________57
B.1 Error Recovery and Troubleshooting................................................................................................................. 57
B.2 Types of Messages and Alert Messages............................................................................................................. 57
B.2.1 Fault Levels................................................................................................................................................. 57
B.2.2 System Messages........................................................................................................................................ 58
B.3 Troubleshooting.................................................................................................................................................... 58
Index _________________________________________________________________________59

Trident User Guide
Table of Contents
MAN-02098 Revision 008 ix
List of Figures
Figure 1: Trident System Components ...........................................................................................................................5
Figure 2: Label Locations................................................................................................................................................10
Figure 3: Cabinet Components ......................................................................................................................................11
Figure 4: Workstation Components ..............................................................................................................................12
Figure 5: Cart Components ............................................................................................................................................12
Figure 6: Cabinet Controls and Indicators ...................................................................................................................13
Figure 7: Display Control and Indicator.......................................................................................................................14
Figure 8: Startup Screen..................................................................................................................................................15
Figure 9: Select an Operator ...........................................................................................................................................16
Figure 10: The Select Patient Screen..............................................................................................................................19
Figure 11: Add a New Patient........................................................................................................................................20
Figure 12: The Edit Patient Information Screen...........................................................................................................21
Figure 13: The Filter Tab in the Patient Filter Screen..................................................................................................22
Figure 14: An Example Procedure Screen ....................................................................................................................24
Figure 15: The Add Procedure Dialog Box...................................................................................................................26
Figure 16: The Print Screen.............................................................................................................................................28
Figure 17: The Taskbar....................................................................................................................................................30
Figure 18: An Acquired Image.......................................................................................................................................33
Figure 19: The Tools Tab in the Procedure Screen ......................................................................................................34
Figure 20: Image Review Tools......................................................................................................................................36
Figure 21: The Comments Tab .......................................................................................................................................38
Figure 22: Annotations Tab ............................................................................................................................................39
Figure 23: The Specimen Tab .........................................................................................................................................40
Figure 24: Procedure Example .......................................................................................................................................41
Figure 25: The Admin Screen.........................................................................................................................................44
Figure 26: The System Tools Button..............................................................................................................................45
Figure 27: The System Tools Screen ..............................................................................................................................46
Figure 28: Removing/Replacing Keyboard Cover.......................................................................................................49
Figure 29: System Dimensions .......................................................................................................................................53

Trident User Guide
Table of Contents
MAN-02098 Revision 008 xi
List of Tables
Table 1: Removal of All Power from the System.........................................................................................................17
Table 2: The Filter Tab Options......................................................................................................................................23
Table 3: The Taskbar Menus...........................................................................................................................................30
Table 4: Admin Screen Functions ..................................................................................................................................44
Table 5: The System Tools ..............................................................................................................................................46
Table 6: User Preventive Maintenance..........................................................................................................................51

Trident User Guide
Chapter 1: Introduction
MAN-02098 Revision 008 Page 1
1: Introduction
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 Intended Use for the User Guide
Always refer to the User Guide for instructions on using the system.
1.3 System Capabilities
The Hologic®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.
1.4 Product Complaints
Report any complaints or problem 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. (See the title page for contact information.)
1.5 Technical Support
Refer to the title page of this manual for contact information for product support.
Chapter 1:

Trident User Guide
Chapter 1: Introduction
Page 2 MAN-02098 Revision 008
1.6 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.
1.7 Installation Instructions
Installation instructions are available in the Service Manual.
1.8 Users
•Primary System User (for example, operating room nurse) to 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.
1.9 Terms and Definitions
AEC
Automatic Exposure Control
Annotations
Graphic or text marks on an image to indicate an area of interest.
DICOM
Digital Imaging and Communications in Medicine
Image Receptor
Captures and digitizes the x-ray images.
PACS
Picture Archiving and Communications System. A computer and
network system that transmits and archives digital medical images.
ROI
Region of Interest
SID
Source to Image Distance
UPS
Uninterruptible Power Supply

Trident User Guide
Chapter 1: Introduction
MAN-02098 Revision 008 Page 3
1.10 International Symbols
This section describes the International Symbols on this system.
"OFF" (power)
"ON" (power)
"OFF" for part of the equipment
"ON" for part of the equipment
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
1.11 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
the damage to equipment, loss of data, or damage to files
in software applications.
Note Notes show additional information.

Trident User Guide
Chapter 2: General Information
MAN-02098 Revision 008 Page 5
2: General Information
2.1 System Description
The system components for x-ray generation are contained in the Shielded Cabinet. The
user interface for data entry, patient selection, and image acquisition and review is
mounted next to the Cabinet.
Figure 1: Trident System Components
Figure Legend
1. Work Surface (Slide-out)
2. Cabinet
3. Display
4. Keyboard
5. Mouse
6. Cart
7. UPS (Optional)
8. Power Strip
9. Computer
Chapter 2:

Trident User Guide
Chapter 2: General Information
Page 6 MAN-02098 Revision 008
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 the
responsibility for injury or damage from incorrect system operation. Hologic can prepare
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 Cautions
WARNING! The users must understand that the system is not
connected to earth ground if the UPS (optional)
is disconnected from the power source.
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 a minimum of 1.5
meters (5 feet) from the patient.