Trident Instructions for Use for Sw Ver 1.1 Rev 006 Jan 2013

Instructions for Use For Software Version 1.1

Part Number MAN-02098 Revision 006 January 2013

Trident Instructions for Use Table of Contents

Table of Contents List of Figures _________________________________________________________________ ix List of Tables __________________________________________________________________ xi Preface _______________________________________________________________________xiii 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0

Intended Use... xiii System Capabilities... xiii Product Complaints... xiii Technical Support ... xiii Hologic Cybersecurity Statement ... xiii Installation Instructions ... xiv Users ... xiv Terms and Definitions ... xiv International Symbols ... xv Warnings, Cautions, and Notes ... xvi

General Information_____________________________________________________________1 1.0 2.0 3.0 4.0 5.0

System Description ... 1 Safety Information ... 2 Warnings and Cautions ... 2 Interlocks ... 4 Compliance ... 5 5.1 Compliance Requirements ... 5 5.2 Compliance Statements ... 5 6.0 Label Locations ... 6

Components, Controls, and Indicators _____________________________________________7 1.0 2.0 3.0

Shielded Cabinet Components... 7 Workstation Components ... 8 Cart Components ... 8 3.1 How to Lock a Caster... 9 3.2 How to Move the Cart ... 9 4.0 Controls and Indicators... 9 4.1 Cabinet Controls and Indicators ... 9 4.2 Display Controls and Indicators ... 10 5.0 Cable Connections ... 10 6.0 How to Start the System ... 11 6.1 Log In ... 12

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Trident Instructions for Use Table of Contents

7.0

How to Shutdown the System... 13 7.1 How to Remove All Power from the System... 13 8.0 Battery Power Operation ... 14 8.1 Battery Alerts ... 14 8.2 How to Stop the Beep From the UPS ... 14

The User Interface ______________________________________________________________15 1.0

The Select Patient Screen... 15 1.1 How to Open a Procedure... 16 1.2 How to Add a New Patient ... 16 1.3 How to Edit the Patient Information ... 17 1.4 How to Delete a Patient ... 17 1.5 The Patient Filter Screen ... 18 1.6 How to Refresh the Worklist ... 19 1.7 How to Query the Worklist... 19 2.0 The Procedure Screen ... 20 2.1 How to Select a Procedure ... 20 2.2 How to Set the Exposure Techniques ... 21 2.3 How to Acquire an Image ... 21 2.4 How to Add a Procedure ... 22 2.5 How to Close a Procedure... 22 3.0 How to Access Image Review Features ... 22 4.0 How to Use the Output Groups ... 22 4.1 How to Select an Output Group... 22 4.2 How to Add or Edit an Output Group ... 23 5.0 How to Use the On-Demand Outputs ... 23 5.1 How to Archive ... 23 5.2 How to Print ... 24 5.3 How to Export... 25 6.0 About the Taskbar... 26 7.0 How to Set Up the Specimen Cabinet ... 27 8.0 How to Do the Gain Calibration ... 28

The Images ____________________________________________________________________29 1.0

Introduction ... 29 1.1 Information on the Left Side of the Image ... 29 1.2 Information on the Right Side of the Image ... 30 2.0 How to Review the Images ... 30 2.1 The Image Review Tools ... 32 2.2 Other Image Review Tools ... 34 3.0 Send the Images to the Output Devices ... 36

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Part Number MAN-02098

Trident Instructions for Use Table of Contents

Clinical Procedures _____________________________________________________________37 1.0 2.0 3.0

System Startup ... 37 Image Acquisition ... 37 System Shutdown ... 38

System Administration Interface _________________________________________________39 1.0 2.0

How to Use the Admin Screen ... 39 How to Use the System Tools ... 41 2.1 The System Tools Screen ... 42

Maintenance, Cleaning, and Disinfecting _________________________________________43 1.0

General Information ... 43 1.1 For General Cleaning ... 43 1.2 For Disinfecting ... 43 1.3 To Prevent Possible Injury or Equipment Damage ... 44 2.0 Workstation ... 44 2.1 How to Clean the Display ... 44 2.2 How to Clean the Keyboard ... 45 3.0 Preventive Maintenance Schedule... 46

System Specifications __________________________________________________________47 1.0 2.0

Shielded Cabinet, Workstation and Cart ... 47 Operation and Storage Environment ... 47 2.1 General Conditions for Operation ... 47 2.2 Storage Environment ... 47 3.0 Workstation Technical Information ... 48 3.1 General Information... 48 3.2 Network Environment... 48 4.0 Electrical Input ... 48 5.0 X-ray Tube Technical Information... 48 5.1 X-Ray Generator ... 48 6.0 Imaging System Technical Information ... 49 6.1 Image Receptor ... 49

The System Messages and Alerts_________________________________________________51 1.0 2.0

Error Recovery and Troubleshooting... 51 Types of Messages and Alert messages ... 51 2.1 Fault Levels ... 51 2.2 System Messages ... 52 3.0 Troubleshooting ... 52

Index _________________________________________________________________________53

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Trident Instructions for Use Table of Contents

List of Figures Figure 1: Trident System Components ... 1 Figure 2: Label Locations ... 6 Figure 3: Cabinet Components ... 7 Figure 4: Workstation Components ... 8 Figure 5: Cart Components ... 8 Figure 6: Cabinet Controls and Indicators ... 9 Figure 7: Display Control and Indicator ... 10 Figure 8: Startup Screen ... 11 Figure 9: Select an Operator ... 12 Figure 10: The Select Patient Screen ... 15 Figure 11: Add a New Patient ... 16 Figure 12: The Edit Patient Information Screen ... 17 Figure 13: The Filter Tab in the Patient Filter Screen ... 18 Figure 14: An Example Procedure Screen ... 20 Figure 15: The Add Procedure Dialog Box... 22 Figure 16: The Print Screen ... 24 Figure 17: The Taskbar ... 26 Figure 18: An Acquired Image ... 29 Figure 19: The Tools Tab in the Procedure Screen ... 30 Figure 20: Image Review Tools ... 32 Figure 21: The Comments Tab ... 34 Figure 22: Annotations Tab ... 35 Figure 23: The Specimen Tab ... 36 Figure 24: Procedure Example ... 37 Figure 25: The Admin Screen ... 39 Figure 26: The System Tools Button ... 41 Figure 27: The System Tools Screen ... 42 Figure 28: System Dimensions ... 47

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Trident Instructions for Use Table of Contents

List of Tables Table 1: Removal of All Power from the System ... 13 Table 2: The Filter Tab Options ... 19 Table 3: The Taskbar Menus... 26 Table 4: Admin Screen Functions ... 40 Table 5: The System Tools ... 42 Table 6: User Preventive Maintenance... 46

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Trident Instructions for Use Preface Intended Use

Preface 1.0

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.

2.0

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.

3.0

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.)

4.0

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

5.0

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.

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Trident Instructions for Use Preface Installation Instructions

6.0

Installation Instructions Installation instructions are available in the Service Manual.

7.0

8.0

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.

Terms and Definitions AEC Annotations DICOM Image Receptor PACS ROI SID UPS

xiv

Automatic Exposure Control Graphic or text marks on an image to indicate an area of interest. Digital Imaging and Communications in Medicine Captures and digitizes the x-ray images. Picture Archiving and Communications System. A computer and network system that transmits and archives digital medical images. Region of Interest Source to Image Distance Uninterruptible Power Supply

Part Number MAN-02098

Trident Instructions for Use Preface International Symbols

9.0

International Symbols This section describes the International Symbols on this system. ʺOFFʺ (power) ʺONʺ (power) ʺOFFʺ for part of the equipment ʺONʺ 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

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Trident Instructions for Use Preface Warnings, Cautions, and Notes

10.0

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

xvi

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 indicate additional information.

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Trident Instructions for Use Chapter 1-General Information System Description

Chapter 1 General Information 1.0

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 Legend 1.

Work Surface (Slide-out)

2.

Cabinet

3.

Display

4.

Keyboard

5.

Mouse

6.

Cart

7.

UPS (Optional)

8.

Power Strip

9.

Computer

Figure 1: Trident System Components

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Trident Instructions for Use Chapter 1-General Information Safety Information

2.0

Safety Information Read and understand this manual before you use the system. Keep the manual available during the procedures. Always follow all the instructions in this manual. Hologic does not accept the responsibility for injury or damage from wrong system operation. Hologic can arrange for training at your facility. The system has protective devices, but the user must understand how to safely operate the system and remember the health hazards of x rays.

3.0

2

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 by 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. The user must arrange for preventive maintenance by an authorized Service Engineer.

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. Part Number MAN-02098

Trident Instructions for Use Chapter 1-General Information Warnings and Cautions

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:

The disk drives installed in this system are a Class I Laser Product. Prevent direct exposure to the beam. Hidden laser radiation exists if the case to a disk drive is open.

Warning:

This system can be dangerous to the patient and the user. Always follow the safety precautions for x-ray exposures.

Caution:

Do not put any magnetic media near or on devices that create any magnetic fields, because stored data can be lost.

Caution:

To minimize 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 spray disinfectant on the system.

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Trident Instructions for Use Chapter 1-General Information Interlocks

Caution:

Caution:

4.0

The weight and mobility of this system require the following precautions:

•

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 cart, make sure the cables are stored in a safe position on the cart.

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.

Interlocks The x-ray generation stops automatically and an error message appears when there is an interruption of an x-ray exposure. For example, the mAs timer or maximum exposure timer times out, the cabinet door is opened, or the key switch is turned to the locked position. To make another exposure:

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1.

Select the OK button in the error message dialog box.

2.

Select the status icon in the taskbar at the bottom of the screen.

3.

Select the Clear All Faults option.

4.

Complete any action (such as ʺclose the doorʺ) that shows in the system message area of the screen.

5.

When READY shows in the system message area, press the X-RAY button

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Trident Instructions for Use Chapter 1-General Information Compliance

5.0

Compliance This section describes the system compliance requirements and the responsibilities of the manufacturer.

5.1

Compliance Requirements The manufacturer has the responsibility for the safety, reliability, and performance of this equipment with the following provisions:

5.2

•

The equipment is used according to Instructions for Use.

•

The assembly operations, extensions, adjustments, changes, or repairs are performed only by authorized persons.

•

The network and communication equipment must be installed to meet IEC Standards.

Caution:

This system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the equipment or shielding the location.

Caution:

Changes or modifications not expressly approved by Hologic could void your authority to operate the equipment.

Compliance Statements The manufacturer states this device is made to meet the following requirements:

•

UL 61010-1, 2nd Edition, 2005-07-22 (Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements)

•

CAN/CSA-C22.2 No. 61010-1, 2nd Edition, 2004-07, (Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements)

•

IEC 61010-1:2001, 2nd Edition, and IEC 61010-1:2010, 3rd Edition.

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Trident Instructions for Use Chapter 1-General Information Label Locations

6.0

Label Locations

Figure 2: Label Locations

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Part Number MAN-02098

Trident Instructions for Use Chapter 2-Components, Controls, and Indicators Shielded Cabinet Components

Chapter 2 Components, Controls, and Indicators

1.0

Shielded Cabinet Components Figure Legend 1.

Specimen location for 2.0x magnification image.

2.

Specimen location for 1.5x magnification image

3.

Specimen location for contact image

Figure 3: Cabinet Components

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Trident Instructions for Use Chapter 2-Components, Controls, and Indicators Workstation Components

2.0

Workstation Components Figure Legend 1.

Display

2.

Keyboard

3.

Mouse

Figure 4: Workstation Components

3.0

Cart Components Figure Legend 1.

Computer

2.

Work Surface (Slide-out)

3.

UPS (optional)

4.

Locking Casters (4)

Figure 5: Cart Components Note

8

The hooks (not shown) on the back of the Cart provide safe storage of the power cord during cart movement.

Part Number MAN-02098

Trident Instructions for Use Chapter 2-Components, Controls, and Indicators Controls and Indicators

3.1

3.2

How to Lock a Caster 1.

To lock a caster, step on the locking lever until the lever locks.

2.

To unlock a caster, lift the locking lever to the up position.

How to Move the Cart 1.

Make sure all components and cables are in a safe position on the cart.

2.

Unlock the caster locks.

3.

Push the cart with one of the side handles.

4.

Make sure to lock the casters when the cart is at the correct location.

4.0

Controls and Indicators

4.1

Cabinet Controls and Indicators

Figure 6: Cabinet Controls and Indicators

Figure Legend 1. Key Switch

2. System Status Indicators

• •

Locked: X ray is disabled.

• •

Power: ON = LED is green.

• 3. Exposure Control 4. X-ray On Indicator

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Unlocked: X ray is enabled. Door: Closed = LED is green. Open = LED is Off. Ready: X ray is ready = LED is green.

X-RAY: Press to begin an exposure. Press to end an exposure before automatic termination. X-RAY ON = LED is amber.

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