Mammography Unit Selenia Dimensions 3d User Manual PDF Free Compressed Parte1
Mammography Unit Selenia Dimensions 3d User Manual PDF Free Compressed Parte1
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© Copyright Hologic 2010. All rights reserved. Printed in USA. This manual was originally written in English.
Hologic and the Hologic Logo are trademarks or registered trademarks of Hologic, Inc. Other trademarks registered or used by Hologic and its divisions and subsidiaries in the
United States and other countries include: Dimensions, DSM, FAST Paddle, HTC, MIMS plus, M-IV, MultiCare, SecurView, Selenia, Smart Paddle, SmartWindow, StereoLoc,
and TechMate. Microsoft and Windows are trademarks or registered trademarks of Microsoft Corporation in the United States and other countries. Any other product and
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User Manual
Table of Contents
Table of Contents
List of Figures ix
List of Tables xi
Preface xiii
1.0 Intended Use ....................................................................................................................................... xiii
2.0 System Capabilities .............................................................................................................................. xiii
3.0 Users ................................................................................................................................................... xiii
4.0 Skills Needed for System Use .............................................................................................................. xiii
5.0 Training Requirements ......................................................................................................................... xiv
6.0 Quality Control Requirements ............................................................................................................. xiv
7.0 Hologic Cybersecurity Statement ......................................................................................................... xiv
8.0 Warnings, Cautions, and Notes ........................................................................................................... xiv
9.0 Terms and Definitions .......................................................................................................................... xv
10.0 International Symbols ........................................................................................................................ xvi
11.0 Document Standards ......................................................................................................................... xvi
Chapter 1—General Information 1
1.0 System Description ................................................................................................................................. 1
2.0 Safety Information .................................................................................................................................. 1
2.1 General Safety .................................................................................................................................. 1
2.2 Patient Safety ................................................................................................................................... 3
2.3 Radiation Safety ............................................................................................................................... 4
2.4 Data Loss ......................................................................................................................................... 5
2.5 Equipment Damage .......................................................................................................................... 5
2.6 Emergency Off Switches ................................................................................................................... 5
2.7 Interlocks ......................................................................................................................................... 6
3.0 Compliance ............................................................................................................................................ 7
3.1 Compliance Requirements ............................................................................................................... 7
3.2 Compliance Statements .................................................................................................................... 7
4.0 Label Locations ...................................................................................................................................... 8
Chapter 2—System Controls and Indicators 9
1.0 System Power Controls ........................................................................................................................... 9
2.0 Acquisition Workstation Controls and Display ...................................................................................... 10
2.1 Keyboard ....................................................................................................................................... 11
2.2 Bar Code Reader ............................................................................................................................ 11
2.3 Acquisition Workstation Touchscreen Display ...............................................................................11
2.4 Preview Display ............................................................................................................................. 11
3.0 Tubestand Controls and Indicators ........................................................................................................ 12
3.1 C-arm Controls ............................................................................................................................... 13
3.2 Compression Device Controls and Displays ................................................................................... 13
3.3 Tubehead Display .......................................................................................................................... 14
3.4 Dual Function Footswitches ...........................................................................................................14
Appendix A—Specifications 73
1.0 Product Measurements ......................................................................................................................... 73
1.1 Tubestand (Gantry with C-arm) ...................................................................................................... 73
1.2 Acquisition Workstation ................................................................................................................ 74
2.0 Operation and Storage Environment .................................................................................................... 75
2.1 General Conditions for Operation ................................................................................................. 75
2.2 Storage Environment ...................................................................................................................... 75
3.0 Acquisition Workstation Technical Information ................................................................................... 75
4.0 Electrical Input ..................................................................................................................................... 76
4.1 Tubestand ...................................................................................................................................... 76
4.2 Acquisition Workstation ................................................................................................................ 76
5.0 Tubestand Technical Information ......................................................................................................... 76
5.1 C-arm ............................................................................................................................................ 76
5.2 Compression ................................................................................................................................. 77
5.3 X-ray Tube ..................................................................................................................................... 77
5.4 X-ray Beam Filtration and Output .................................................................................................. 78
5.5 X-ray Collimation .......................................................................................................................... 79
5.6 Light Field Indication ..................................................................................................................... 79
5.7 X-ray Generator ............................................................................................................................. 79
6.0 Imaging System Technical Information ................................................................................................. 79
6.1 Image Receptor ............................................................................................................................. 79
Appendix B—The System Messages and Alert Messages 81
1.0 Error Recovery and Troubleshooting .................................................................................................... 81
2.0 Types of Messages and Alert messages ................................................................................................. 81
2.1 Fault Levels ................................................................................................................................... 81
2.2 System Messages ........................................................................................................................... 82
List of Addenda 83
Index 85
List of Figures
Figure 1-1: Selenia Dimensions .................................................................................................................... 1
Figure 1-2: Label Locations........................................................................................................................... 8
Figure 2-1: System Power Controls ............................................................................................................... 9
Figure 2-2: Acquisition Workstation Controls and Displays ........................................................................ 10
Figure 2-3: Tubestand Controls and Indicators............................................................................................ 12
Figure 2-4: C-arm Controls ......................................................................................................................... 13
Figure 2-5: Compression Device................................................................................................................. 13
Figure 2-6: Compression Display................................................................................................................ 13
Figure 2-7: Tubehead Display..................................................................................................................... 14
Figure 2-8: Dual Function Footswitches...................................................................................................... 14
Figure 2-9: The Startup Screen.................................................................................................................... 15
Figure 2-10: How to Log In......................................................................................................................... 16
Figure 2-11: C-arm Controls (left side shown) ............................................................................................. 17
Figure 2-12: Power Buttons ........................................................................................................................ 23
Figure 3-1: An Example Select Function to Perform Screen......................................................................... 25
Figure 3-2: An Example Gain Calibration Screen ........................................................................................ 26
Figure 3-3: How to Select a Patient............................................................................................................. 27
Figure 3-4: How to Add a New Patient ....................................................................................................... 28
Figure 3-5: The Filter Tab in the Patient Filter Screen.................................................................................. 29
Figure 3-6: An Example Generator Tab in the Procedure Screen................................................................. 31
Figure 3-7: The Add View Screen ............................................................................................................... 33
Figure 3-8: The Add Procedure Dialog Box ................................................................................................ 34
Figure 3-9: The Edit View Screen................................................................................................................ 34
Figure 3-10: The Print Screen ..................................................................................................................... 37
Figure 4-1: The Preview Screen .................................................................................................................. 41
Figure 4-2: The Tools Tab in the Procedure Screen..................................................................................... 42
Figure 4-3: Marked Images in a Procedure.................................................................................................. 42
Figure 4-4: Image Review Tools.................................................................................................................. 43
Figure 4-5: Image Review Tabs................................................................................................................... 44
Figure 4-6: Icons Available on the Notices Tab........................................................................................... 44
Figure 4-7: The Exposure Index .................................................................................................................. 44
Figure 5-1: C-arm Accessories .................................................................................................................... 47
Figure 5-2: How to Install the Conventional Face Shield............................................................................. 48
Figure 5-3: How to Align the Retractable Face Shield on the C-arm............................................................ 49
Figure 5-4: Installation................................................................................................................................ 50
Figure 5-5: Operation ................................................................................................................................. 50
Figure 5-6: How to Install a Compression Paddle ....................................................................................... 53
Figure 5-7: How to Remove the Compression Paddle ................................................................................. 53
Figure 5-8: The FAST Compression Mode Slide .......................................................................................... 54
Figure 5-9: Installation of the Magnification Stand ...................................................................................... 55
Figure 5-10: How to Attach the Localization Crosshair Device ................................................................... 56
Figure 5-11: How to Install and Remove the Magnification Crosshair Device ............................................. 57
Figure 6-1: Screening Example, Conventional Procedure............................................................................ 60
Figure 8-1: The Admin Screen .................................................................................................................... 68
Figure A-1: Tubestand Dimensions ............................................................................................................. 73
Figure A-2: Acquisition Workstation Dimensions........................................................................................ 74
List of Tables
Table 2-1: C-arm Functional Tests ............................................................................................................... 17
Table 3-1: Taskbar Menus ........................................................................................................................... 39
Table 8-1: Admin Screen Functions ............................................................................................................. 69
Table 8-2: Radiologic Technologist Manager—Service Tools Functions....................................................... 71
Table A-1: mA Setting as a Function of kV................................................................................................... 78
Table B-1: System Messages ........................................................................................................................ 82
Preface
1.0 Intended Use
The Hologic Selenia® Dimensions® Digital Breast Tomosynthesis System generates digital
mammographic images that can be used for screening and diagnosis of breast cancer. The
Selenia Dimensions system is intended for use in the same clinical applications as Full Field
Digital Mammography systems for screening mammograms. Specifically, the Selenia
Dimensions system can be used to acquire two-dimensional full field digital mammograms
and three-dimensional tomosynthesis mammograms. The screening examination will consist
of a two-dimensional image set or a two-dimensional and tomosynthesis image set. The
Selenia Dimensions system may also be used for additional diagnostic workup of the breast.
3.0 Users
• A Technologist to acquire and review images
• A Technologist with the manager permissions to perform the Quality Assurance
• A system administrator to enable permissions
• A Medical Physicist to perform the Quality Control tests
• A Radiologist can use the system with a Technologist
• The service personnel to install the system, set the site system configurations and
calibrations, and find faults
Caution: Cautions point out procedures that you must follow accurately to
prevent the damage to equipment, loss of data, or damage to files in
software applications.
Manufacturer
Date of Manufacture
WARNING! Lethal voltages exist inside of this system. Do not open any
of the panels.
Warning: The user or the service personnel must correct problems before
the system is used.
Caution: The system is a medical 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 medical device
is not provided (for example, a computer firewall). The network
security and anti-virus provisions are the responsibility of the user.
Caution: Only use the approved accessories with this equipment. The failure to
follow this caution can cause errors and possible data loss.
Note… Hologic does not provide the Gantry power cable for some countries. If
the power cable is not provided, the installed cable must meet the
following requirements and all local codes that apply: 3 conductor, 8
AWG (10 mm2) copper not more than 25 feet (7.62 meters) in length.
WARNING! After power failure, remove the patient from the system
before you apply power.
WARNING! To keep the isolation quality for the system, attach only
approved accessories or options to the system. Only the
authorized personnel can make changes to the
connections.
WARNING! Keep a 1.5 meter safe distance between the patient and
any non-patient devices.
Non-patient system components (like the Workflow
Manager, the diagnostic review workstation, or the hard
copy printer) must not be installed in the Patient Area.
1.5m
Warning: Never leave the patient during the procedure if in contact with
the mammography system.
Warning: Keep the hands of the patient away from all buttons and
switches at all times.
Warning: You increase the patient dose to high levels if you increase the
AEC exposure adjustment setting. You increase the image noise
or decrease image quality if you decrease the AEC exposure
adjustment setting.
Warning: Put both footswitches away from the patient and C-arm area to
prevent any accidental footswitch use. When the patient has a
wheelchair, put the footswitches away from the area.
WARNING! This x-ray system can be dangerous to the patient and the
user. Always follow the safety precautions for x-ray
exposures.
Warning: For exposures except magnification case studies, always use the
Face Shield.
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: The bar code reader installed in this system is a Class II Laser
Product. Prevent direct exposure to the beam. Hidden laser
radiation exists if the cover is opened.
Warning: You must keep your complete body behind the radiation shield
for the time of the exposure for maximum protection from x-ray
exposure.
Warning: Do not move the C-arm while the system retrieves the image.
Caution: Never turn off the Acquisition Workstation Circuit Breaker except in
emergency. The circuit breaker can turn off the Uninterruptible Power
Supply (UPS) and risk data loss.
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: Do not spray disinfectant on the system, because the moisture can
enter the system and damage the electronic components.
2.7 Interlocks
The Selenia Dimensions has safety interlocks:
• The C-arm vertical drive and rotation is disabled when 45 Newtons (10 pounds) or
greater of compression force is displayed.
• If the x-ray button is released before the end of the exposure, the exposure stops and an
alarm message appears.
• When in Tomo mode, the system does not allow the Grid in the x-ray field
(Tomosynthesis option).
• Mirror and Filter interlocks prevent the x-ray exposure when the Light Field Mirror or the
Filter is not aligned.
3.0 Compliance
This section describes the mammography system compliance requirements and the
responsibilities of the manufacturer.
2.1 Keyboard
Use the keyboard in the front drawer of the Acquisition Workstation for data entry.
cm Rh
SID: 70 9 C
x2
Coll: 24
Warning: Put both footswitches away from the patient and C-arm area to
prevent any accidental footswitch use. When the patient has a
wheelchair, put the footswitches away from the area.
4.2 Startup
1. Press the UPS button at the rear of the Acquisition Workstation if the UPS was shut
down.
2. Press the computer power button at the rear of the Acquisition Workstation (see
Figure 2-1, page 9, number 4).
Note… The system requires between 5 minutes and 45 minutes to prepare for
image acquisition. The wait time depends on the detector power
configuration. A timer in the Taskbar displays the wait time before the
system is ready. Do not acquire clinical or QC images unless the System
Status Icon indicates the system is Ready.
Note… The Startup screen includes a Shutdown button that turns off the whole
system, and a Reboot button that restarts the system.
4.3 Log In
When the user Log In screen displays, all Managers and Technologists show in the list of
Operators.
1. To display the Service, Applications, and Physicists user names, select the Show All
button.
2. Select your user name, enter your password, and select the Log In button.
Or
Validate your fingerprint.
The following Functional Tests make sure that the control operates correctly.
Clockwise C-arm Rotation Press the Clockwise C-arm Rotation button to start
clockwise C-arm rotation.
C-arm Rotation Switch Push the C-arm Rotation switch away from you to move the
C-arm toward you.
Pull the C-arm Rotation switch toward you to move the
C-arm away.
The C-arm movement stops when the switch is released.
Light Field Lamp Press the light field lamp button to see the x-ray field for
approximately 30 seconds.
The light field lamp automatically illuminates with the start
of the Compression Down movement.
Emergency Off Switches There are three Emergency Off switches, one on each side of
the Gantry and one on the Acquisition Workstation.
Press any of the Emergency Off switches to turn Off the
Gantry.
Turn the Emergency Off switch by one-quarter turn to reset
the switch.
1. After the system completes the shutdown, press the UPS button (Number 3) next to the
Acquisition Workstation circuit breaker.
2. Turn off the Acquisition Workstation circuit breaker (Number 1).
3. Disconnect the Acquisition Workstation power cable.
Note… The Select Patient screen appears if you are not scheduled to perform
any Quality Control tasks.
Note… If you select the Skip button, the Select Patient screen appears.
Note… When the Start button is not enabled for a Quality Control task, select
the Mark Completed button.
Note… You can perform required Quality Control tasks at another time. Select
the Admin button (on the Select Patient screen). Select the Quality
Control button on the Admin screen to display the list.
Note… If a calibration is scheduled on the current date, you can not perform a
procedure until the calibration is completed.
Eight tabs display at the top of the screen. These tabs are configurable. A user with the right
permissions can delete tabs and create new tabs.
• The Scheduled tab displays the scheduled procedures.
• The In Progress tab displays the procedures not complete.
• The Completed tab displays the completed procedures.
• The Discontinued tab displays the procedures started, but discontinued.
• The Current User tab displays the procedures for the current Operator.
• The Reject tab displays the procedures with rejected views.
• The All tab displays all procedures for all users.
• The QC tab displays the Quality Control procedures.
You can perform many functions from this screen:
• Add a new Patient (New)—see Section 3.2, page 28.
• Edit the patient information (Edit)—see Section 3.3, page 28.
• Delete a patient from the worklist (Delete)—see Section 3.4, page 28.
• Use a Patient Filter (Filter)—See Section 3.5, page 29.
• Search for a patient in the Modality Worklist (Query)—see Section 3.7, page 30.
• Use the Admin Screen (Admin)—see Chapter 8, page 67.
• Exit (Log Out)—see Section 3.9, page 30.
• Find your patients in the database (tabs at the top of screen).
Note… The Technologists do not have the user permission to delete patients.
From the Filter and Column tabs, select the information that appears on the selected tab page
of the Select a Patient screen.
• The Filter tab accesses the parameters that select the patients who appear on the selected
tab page.
• The Columns tab adds or removes columns on the selected tab page.
• Select a line in the Results list to activate the Open button. When you select the Open
button, the Procedure screen for that patient appears.
Note… Your logon permissions can allow you to add, change or delete the tabs
on the Select a Patient screen from the Patient Filter screen.
The Save button changes the name of the selected tab.
The Save As button creates a new tab.
The Delete button deletes the selected tab.
View Modifiers
ID = Implant Displaced
RL = Rolled Lateral
RM = Rolled Medial
RI = Rolled Inferior
RS = Rolled Superior
NP = Nipple in Profile
AC = Anterior Compression
IMF = Infra-Mammary Fold
AX = Axillary Tissue
Note… Use the Manage Queue utility in the task bar to review the image
status.
Note… A default paddle position for each view is set in Service Tools.
2. From the paddle shift section of the screen, select the button for the new paddle
position. The paddle moves to the new position.
Description Menu
1 Information Icon
Select the Information icon to display a menu.
This section of the taskbar flashes a yellow color if an alarm exists.
Select Acknowledge All to remove the flashing indication. Select the
Manage Alarms option to display and close any open alarms.
2 Current User Name
Select the user name to display a menu.
Log Out returns you to the Sign-in screen.
My Settings displays the Edit Operator screen to review or edit
Operator information, change your password, or use the
Fingerprint Capture feature.
Print prints the displayed patient list to a connected printer.
3 Output Device Icons
Select an output icon (query retrieve, workstation/archive, printer,
or CD-ROM) to display a menu. Each menu selection takes you to
the screen for that selection.
Manage Queues displays the status of jobs in the queue and job
details for the selected output, and allows you to filter the queue
display.
4 Notice Icon
Select the Notice icon to display a menu.
Select Acknowledge All to remove the flashing indication.
The Manage Notices icon allows you to select the display options
for the message like date or title.
5 System Status Icons
Select the Tubehead icon to display a menu. When a green
checkmark appears next to the tubehead icon, the detector and
generator are ready for use.
Clear All Faults deletes all error messages.
Zero Tubehead puts the tubehead at zero degrees of rotation for the
next exposure.
System Diagnostics accesses Subsystem settings.
System Defaults opens the Gantry Defaults screen to set the
Compression and Generator default values.
About displays information about the Acquisition Workstation.
Select any thumbnail image to display that image in the Preview screen. The thumbnail
image is marked if the image is not accepted.
The Exposure Index is an image quality guide. When the Exposure Index indicates
the red or yellow area, review the selected image for noise and make a decision
about a retake.
Warning: The Face Shield must be attached for all exposures except
magnification case studies.
Figure 5-3: How to Align the Retractable Face Shield on the C-arm
10 cm Contact 15 cm Contact
Frameless Paddle Frameless Paddle
10 cm Perforated 15 cm Perforated
Localization Paddle Localization Paddle
10 cm Magnification 15 cm Magnification
Localization Perforated Paddle
Paddle