User Guide
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Artwork and Signature File for: MAN-04068 “MNL, AFFIRM, USER GUIDE V1.8”
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J. SHARP
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DATE
07/30/14 DATE
07/31/14
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.
TITLE
DOCUMENT NUMBER
REV
AW, MNL, AFFIRM, USER GUIDE V1.8
AW-11807
001
ARTWORK
SIZE A
SHEET 1 OF 1 ENG-0034-T33, Rev. 002
User Guide For Software Version 1.8
Part Number MAN-04068 Revision 001 July 2014
Affirm User Guide Table of Contents
Table of Contents List of Figures _________________________________________________________________ ix List of Tables __________________________________________________________________ xi Chapter 1 Introduction ___________________________________________________________1 1.1 1.2 1.3 1.4 1.5 1.6 1.7
Intended Use... 1 Intended Use for the User Guide ... 1 Product Complaints ... 1 Technical Support ... 1 Quality Control ... 1 Installation Instructions ... 1 User Profiles... 2 1.7.1 Mammography Technologist ... 2 1.7.2 Radiologists, Surgeons ... 2 1.7.3 Medical Physicist ... 2 1.8 Training Requirements... 2 1.9 Terms and Definitions ... 3 1.10 International Symbols ... 5 1.11 Warnings, Cautions, and Notes ... 6
Chapter 2 General Information ___________________________________________________7 2.1 2.2 2.3 2.4 2.5 2.6 2.7
System Description ... 7 How to Handle the Biopsy Guidance Module... 8 Biopsy Guidance Module Components ... 9 Biopsy Control Module Components ... 10 Safety ... 11 Warnings and Precautions... 11 Compliance Information ... 13 2.7.1 Requirements ... 13 2.7.2 Label Locations... 13
Chapter 3 How to Install or Remove the System ___________________________________15 3.1
Installation of Components ... 15 3.1.1 How to Attach the Biopsy Guidance Module ... 15 3.1.2 How to Attach the Biopsy Control Module ... 16 3.2 Installation and Removal of Accessories ... 17 3.2.1 Biopsy Compression Paddles ... 17 3.2.2 Biopsy Device Holder... 18 3.2.3 Needle Guides ... 19 3.2.4 Affirm Table-top Stand ... 20 3.3 Removal of Main Components ... 21 3.3.1 Biopsy Control Module ... 21 MAN-04068 Revision 001
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Affirm User Guide Table of Contents
3.3.2
Biopsy Guidance Module... 21
Chapter 4 How to Use the System ________________________________________________23 4.1
System Verifications ... 23 4.1.1 Confirm the Host Connection ... 23 4.1.2 The QAS Test ... 23 4.2 Biopsy Control Module Screens ... 26 4.2.1 Home Screen ... 26 4.2.2 Target Guidance Screen ... 27 4.2.3 Jog Mode Screen ... 31 4.2.4 Select Target Screen ... 33 4.3 Selenia Dimensions ... 34 4.3.1 Biopsy Views ... 34 4.3.2 C-Arm Stereo Modes ... 36 4.3.3 Biopsy Tab ... 39 4.3.4 Stereotactic Lesion Targeting ... 43 4.3.5 Lesion Targeting with Tomosynthesis ... 44 4.3.6 Lesion Targeting Using Multi-Pass ... 45 4.3.7 Post Biopsy ... 49 4.3.8 Printing Stereo Images ... 49
Chapter 5 Care and Cleaning ____________________________________________________51 5.1 5.2 5.3
General Information ... 51 Preventive Maintenance Schedule ... 51 For General Cleaning ... 51 5.3.1 How to Clean the Biopsy Control Module Screen... 52 5.3.2 To Prevent Possible Injury or Equipment Damage ... 52 5.4 Geometry Calibration ... 53 5.4.1 Geometry Calibration Procedure ... 53
Chapter 6 Troubleshooting ______________________________________________________55 6.1 6.2
Audible Alerts ... 55 Error Messages ... 55
Appendix A System Specifications _______________________________________________57 A.1 A.2 A.3
Affirm Measurements ... 57 Biopsy Guidance Module ... 57 Biopsy Control Module ... 57
Appendix B Forms _____________________________________________________________58 B.1
QAS Test Checklist ... 58
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Affirm User Guide Table of Contents
Appendix C CNR Correction for Biopsy __________________________________________59 C.1
CNR Correction for Stereotactic Biopsy ... 59 C.1.1 AEC Table 0 (Standard Stereotactic Biopsy Dose) ... 59 C.2 CNR Correction for Biopsy Under Tomosynthesis Option ... 59 C.2.1 AEC Table 0 (Tomosynthesis Option: Standard Tomo Dose) ... 59
Index _________________________________________________________________________61
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Affirm User Guide Table of Contents
List of Figures Figure 1: Affirm on the Selenia Dimensions ... 7 Figure 2: How to Lift the Biopsy Guidance Module ... 8 Figure 3: How to Store the Biopsy Guidance Module ... 8 Figure 4: Biopsy Guidance Module ... 9 Figure 5: Biopsy Control Module ... 10 Figure 6: Label Location... 13 Figure 7: Installation of the Biopsy Guidance Module ... 15 Figure 8: Attachment of the Biopsy Control Module... 16 Figure 9: How to Install the Needle Guides ... 19 Figure 10: Affirm Table-top Stand ... 20 Figure 11: Home Screen on the Biopsy Control Module ... 23 Figure 12: Admin Screen... 24 Figure 13: The Home Screen... 26 Figure 14: Target Guidance Screen ... 28 Figure 15: Green Differential Cells ... 29 Figure 16: Yellow and Red Cells ... 29 Figure 17: Alert Sounds are Audible ... 30 Figure 18: Alert Sounds are Muted ... 30 Figure 19: Jog Mode Screen ... 32 Figure 20: Select Target Screen... 33 Figure 21: Add a Biopsy View Screen ... 34 Figure 22: Edit Biopsy View Screen... 35 Figure 23: Stereo Mode ... 37 Figure 24: C-Arm Mode ... 37 Figure 25: System Status Icon... 38 Figure 26: System Status Menu ... 38 Figure 27: System Defaults Screen... 38 Figure 28: The Biopsy Tab ... 39 Figure 29: Slice Indicator... 40 Figure 30: Function Buttons and Data on the Biopsy Tab ... 41 Figure 31: Multi-Pass Options ... 45 Figure 32: Four Offset Target Points Established Around Center Target Point ... 46 Figure 33: 3 mm Spacing of Offset Points... 47 Figure 34: 5 mm Spacing of Offset Points... 47 Figure 35: Single Point Target Selected... 47 Figure 36: Single Point Target Deselected ... 47 Figure 37: Multi-Pass Target Selected ... 47 Figure 38: Multi-Pass Target Deselected ... 47 Figure 39: Biopsy Order Between Target Sets ... 48 Figure 40: Biopsy Order of a Three Offset Target ... 48 Figure 41: Biopsy Order of a Four Offset Target ... 48
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Affirm User Guide Table of Contents
Figure 42: Biopsy Order of a Five Offset Target ... 48 Figure 43: Stereo Pair Print Screen ... 49
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Affirm User Guide Table of Contents
List of Tables Table 1: Components of the Biopsy Guidance Module ... 9 Table 2: Components of the Biopsy Control Module... 10 Table 3: How to Use the Sound Button ... 30 Table 4: The C-Arm Stereo Mode Button ... 37 Table 5: How to Select the C-Arm Stereo Mode ... 38 Table 6: Radiologic Technologist Preventive Maintenance Schedule... 51 Table 7: Affirm Audible Alerts ... 55 Table 8: Affirm Error Messages ... 55
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Affirm User Guide Chapter 1-Introduction
Chapter 1 Introduction Chapter 1
1.1
Intended Use United States federal law restricts this device to use by, or on the order of, a physician. The Affirm™ breast biopsy guidance system is an optional accessory for the Selenia® Dimensions® digital mammography system. Its function is to localize lesions accurately in the breast in three dimensions. It is intended to provide targeting guidance for interventional procedures such as biopsy, presurgical localization, or treatment devices.
1.2
Intended Use for the User Guide Always refer to the User Guide for instructions on using the system.
1.3
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.)
1.4
Technical Support Refer to the title page of this manual for contact information for product support.
1.5
Quality Control Facilities that are ACR accredited must follow the 1999 Stereotactic Breast Biopsy Quality Control Manual. Facilities that are not ACR accredited can follow the above manual or perform the QAS Test described in this manual at the required interval.
1.6
Installation Instructions Installation instructions are available in the Service Manual.
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Affirm User Guide Chapter 1-Introduction
1.7
User Profiles
1.7.1
Mammography Technologist
1.7.2
•
Meets all requirements that apply to the location in which the Mammography Technologist operates.
• •
Completed training on the mammography system.
• • •
Knows about Stereotactic breast biopsy procedures.
•
Understands sterile procedures.
1.8
Knows how to operate a computer and its peripherals. Can lift 20 pounds to shoulder height with two hands (necessary for upright stereotactic systems).
Radiologists, Surgeons • • • • • •
1.7.3
Has training in mammography positions.
Meets all requirements that apply to the location in which the Physician operates. Knows about Stereotactic breast biopsy procedures. Knows how to operate a computer and its peripherals. Understands sterile procedures. Gives local anesthesia. Knows about basic surgical procedures for core biopsy.
Medical Physicist •
Meets all requirements that apply to the location in which the Medical Physicist operates.
• • •
Knows about mammography. Has experience with digital imaging. Knows how to operate a computer and its peripherals.
Training Requirements In the United States, users must be Registered Radiologic Technologists meeting criteria to perform mammography. The mammography users must meet all applicable MQSA personnel requirements under FDA guidelines for conventional and digital mammography. The user has options available for training, which include but are not limited to:
• •
Onsite applications training by a Hologic Clinical Services Specialist Onsite on the job training also known as peer training
Additionally, the user manual is a guide for directions on how to use the system. 2
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Affirm User Guide Chapter 1-Introduction
All users must make sure that they receive training on correct operation of the system before use on patients. Hologic does not accept the responsibility for injury or damage from wrong system operation.
1.9
Terms and Definitions
Affirm Biopsy Control Module Biopsy Guidance Module
C-Arm Mode CEDM CE2D Comm Diff Exposure Technique I-ViewTM Multi-Pass
Needle Approach Angle QAS Safety Margins
Stereo Mode Stereotactic Procedure Stereotactic View
Stroke Margin
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The breast biopsy guidance system for the Selenia Dimensions The user control device for the Affirm breast biopsy guidance system Holds and operates the biopsy device. Responds to commands from the Biopsy Control Module to move the device into position and do the biopsy. Lets the C-arm and Tube Arm to move together to the Needle Approach angle for the Localization procedure. Contrast Enhanced Digital Mammography Hologic term for CEDM Communication Differential Combination of x ray parameters (kVp, mAs, filter) for an acquired image A licensed feature for 2D Contrast Enhanced Digital Mammography Allows you to automatically generate up to five offset target points all equidistant (up to 5mm away) from the original target point The angle of incidence of the needle to the breast Quality Assurance Standard The minimum space allowed between the biopsy device needle that is installed and components of the Selenia Dimensions system. Lets the Tube Arm rotate for acquisition of stereotactic images while the C-arm stays in position. A type of examination that allows stereotactic views at the Acquisition Workstation. A specialized image view that causes the application to capture a stereotactic images. The safety margin (in mm) that remains between the fired needle position and the breast platform.
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Affirm User Guide Chapter 1-Introduction
Tomosynthesis
View
4
An imaging procedure which combines a number of projections taken at different angles. The tomosynthesis images can be reconstructed to show focal planes (slices) within the object (Tomosynthesis option). The combination of one x-ray image and a specified set of conditions for image acquisition.
X-axis
•
The (lateral) axis from left to right across the biopsy window
Y-axis
•
The (longitudinal) axis from front to back above the biopsy window
Z-axis
•
The (vertical) axis through the biopsy window
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Affirm User Guide Chapter 1-Introduction
1.10
International Symbols This section describes the International Symbols on this system. Potential Equalization terminal
Protective Earth terminal "On" and "Off" (power) for the computer and display. Discard electrical and electronic equipment separately from standard waste. Send decommissioned material to Hologic or contact your service representative. Manufacturer Date of Manufacture
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Affirm User Guide Chapter 1-Introduction
1.11
Warnings, Cautions, and Notes Descriptions of Warnings, Cautions, and Notes used in this manual:
6
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.
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Affirm User Guide Chapter 2-General Information
Chapter 2 General Information Chapter 2
2.1
System Description The Affirm attaches to the Selenia Dimensions. A biopsy device attaches to the Affirm. Xand Y-axes motors in the Affirm move the biopsy device left or right and forward or back. Z-axis movement is manual. The Affirm Biopsy system has two main components:
•
Biopsy Guidance Module
•
Biopsy Control Module
The Tube Arm on the Selenia Dimensions moves separately from the Compression Arm to allow the acquisition of stereotactic images for the procedure. Refer to the Selenia Dimensions User Guide for complete information about that system. Affirm licensing displays on the Acquisition Workstation screen as "Stereo Licensed". Refer to Licensing Setup in System Tools of the Operating System.
Figure 1: Affirm on the Selenia Dimensions Figure Legend
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1.
Biopsy Guidance Module
2.
Biopsy Control Module
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Affirm User Guide Chapter 2-General Information
2.2
How to Handle the Biopsy Guidance Module Caution:
To prevent damage or alignment problems with the Needle Guidance Stage, be careful when you move the Biopsy Guidance Module.
Caution:
The Affirm Biopsy Guidance Module weighs 15 pounds. When you move it, be sure to have a secure grip on the handles.
•
Only lift the Biopsy Guidance Module with the handles.
Figure 2: How to Lift the Biopsy Guidance Module
•
When the Biopsy Guidance Module is not in use, put the device on its back.
Figure 3: How to Store the Biopsy Guidance Module
8
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2.3
Biopsy Guidance Module Components The Biopsy Guidance Module installs on the front of the Selenia Dimensions. A lock lever (item 8) secures this module in position. A cable (item 7) connects to the Selenia Dimensions for operation of the biopsy guidance system.
Figure 4: Biopsy Guidance Module Table 1: Components of the Biopsy Guidance Module #
Name
1
Attachment Hooks
2
Handles
3 4
Z-axis Control Knobs Z-axis Slide Rail
5 6
Front Needle Guide Biopsy Device Holder
7
Cable
8
Lock Lever
9
Receptacle
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Description Two on each side hold the Biopsy Guidance Module on the Selenia Dimensions gantry. One on each side. Hold both handles to lift the Biopsy Guidance Module. Rotate either knob to move the biopsy device along the Z-axis. Holds the biopsy device holder and provides the track for Z-axis movements. Attaches to the Needle Guide Mount on the Biopsy Device Holder. Holds the biopsy device. Moves along the Z-axis Slide Rail when a Z-axis Control Knob is rotated. Connects to Selenia Dimension to bring power to the Affirm. One on each side. Engage both levers to lock the Biopsy Guidance Module in position and on the Selenia Dimensions gantry. Accepts the cable from the Biopsy Control Module.
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2.4
Biopsy Control Module Components The Biopsy Control Module attaches to either the left or right handle on the Biopsy Guidance Module with a bracket (item 5). The display screen (item 2) is a touch screen for the user to perform the desired tasks. Motor Enable buttons (item 3) on either side of this module (and at the rear) activate motorized movement of the biopsy device.
Figure 5: Biopsy Control Module Table 2: Components of the Biopsy Control Module #
10
Name
Description
1
Cable
Connects to Biopsy Guidance Module.
2
Display Screen
3
Motor Enable Buttons
4
Articulating Arm Lock and Release
5
Attachment Bracket
Shows targets, system status, name of the biopsy device, and safety margins. Touch buttons allow option selection. Front and back button pairs on either side of the display. Press the front and back buttons of either side at the same time to activate a motor movement. Rotate to release the lock and adjust the module. Rotate in the opposite direction to lock the arm and hold the module in the new position. Attaches to either handle of the Biopsy Guidance Module.
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Affirm User Guide Chapter 2-General Information
2.5
Safety Read and understand this manual before you use the system. Keep this manual available during the patient exams. 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 Technologist must understand how to safely use the system. The Technologist must remember the health hazards of x rays. Do not connect this equipment to any system or component not described in this manual. A combination of components must have the data to validate the safety of the patient, personnel, and the environment. Any additional certification becomes the responsibility of the user.
2.6
Warnings and Precautions WARNING!
After power failure, remove the patient from the system before you apply power.
Warning:
You make x rays when you use the procedures in this manual.
Warning:
C-arm movement is motorized.
Warning:
The Tube Arm movement is motorized.
Warning:
Only qualified users can use this system.
Warning:
Do not use this equipment if any faults or problems are detected
Warning:
The user must prepare for preventive maintenance by an approved servicing engineer.
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Affirm User Guide Chapter 2-General Information
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Warning:
The user or a servicing engineer must correct problems before the system is used.
Warning:
Do not leave the patient unattended during the exam.
Warning:
Keep the hands of the patient away from all buttons and switches at all times.
Caution:
To prevent damage or misalignment, be careful when you move the Affirm.
Caution:
The Affirm Biopsy Guidance Module weighs 15 pounds. When you move it, be sure to have a secure grip on the handles.
Note
The system does not have any parts that are serviced by the user.
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