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585 views70 pages

Mammography Unit Selenia Dimensions 3d User Manual PDF Free Compressed Parte1

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Selenia Dimensions User Manual

Part Number MAN-01964


Revision 001
July 2010

Technical Support:
USA: +1.877.371.4372
Europe: +32.2.711.4690
Asia: +852 37-48-77-00
All Other: +1.781.999.7750

Corporate Headquarters Europe


(EU Representative)
35 Crosby Drive,
Bedford, MA 01730-1401 USA Hologic NV
Tel: +1.781.999.7300 Leuvensesteenweg 250A
Sales: +1.781.999.7453 1800 Vilvoorde, Belgium
Fax: +1.781.280.0668 Tel: +32.2.711.4680
www.hologic.com Fax: +32.2.725.2087
Refer to the corporate website for more facilities worldwide.

© 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
company names mentioned herein are the trademarks or registered trademarks of their respective owners.
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

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4.0 How to Turn On the Selenia Dimensions ............................................................................................. 15


4.1 Preparation .................................................................................................................................... 15
4.2 Startup ........................................................................................................................................... 15
4.3 Log In ............................................................................................................................................ 16
5.0 Perform the Functional Tests ................................................................................................................ 17
6.0 How to Turn Off the System ................................................................................................................. 23
7.0 How to Remove All Power from the Acquisition Workstation .............................................................. 23
Chapter 3—The User Interface 25
1.0 Select the Function to Perform ............................................................................................................. 25
2.0 How to Perform the Quality Control Tasks ........................................................................................... 26
3.0 How to Select a Patient ........................................................................................................................ 27
3.1 How to Open a Procedure ............................................................................................................. 27
3.2 How to Add a New Patient ............................................................................................................ 28
3.3 How to Edit the Patient Information ............................................................................................... 28
3.4 How to Delete a Patient ................................................................................................................ 28
3.5 How to Use a Patient Filter ............................................................................................................ 29
3.6 How to Refresh the Worklist .......................................................................................................... 29
3.7 How to Query the Worklist ........................................................................................................... 30
3.8 About the Admin Button ................................................................................................................ 30
3.9 How to Log Out ............................................................................................................................ 30
4.0 The Procedure Screen .......................................................................................................................... 31
4.1 How to Set the Exposure Parameters .............................................................................................. 31
4.2 How to Use the Implant Present Button ......................................................................................... 32
4.3 How to Acquire an Image .............................................................................................................. 32
4.4 How to Add or Remove a View ..................................................................................................... 33
4.5 How to Add a Procedure ............................................................................................................... 34
4.6 How to Edit a View ....................................................................................................................... 34
4.7 How to Close a Procedure ............................................................................................................. 35
5.0 How to Access Image Review Features ................................................................................................ 35
6.0 How to Use the Output Sets ................................................................................................................. 35
6.1 How to Select an Output Set ......................................................................................................... 35
6.2 How to Add or Edit an Output Set ................................................................................................. 35
7.0 How to Use the On-Demand Outputs .................................................................................................. 36
7.1 How to Archive ............................................................................................................................. 36
7.2 How to Print .................................................................................................................................. 37
7.3 How to Export ............................................................................................................................... 38
8.0 How to Use the Paddle Shift Feature .................................................................................................... 38
9.0 About the Taskbar ................................................................................................................................ 39
Chapter 4—The Images 41
1.0 Introduction ......................................................................................................................................... 41
1.1 Conventional Sequence of Events .................................................................................................. 41
1.2 Tomosynthesis Sequence of Events (Tomosynthesis option) ........................................................... 41
2.0 How to Review the Images .................................................................................................................. 42
2.1 The Image Review Tools Tab ......................................................................................................... 43
2.2 Other Image Review Tools ............................................................................................................ 44
2.3 How to Correct and Reprocess Implant Images .............................................................................. 45
3.0 Send the Images to the Output Devices ................................................................................................ 45

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Chapter 5—How to Use the Accessories 47


1.0 Introduction .......................................................................................................................................... 47
2.0 How to Install Accessories on the C-arm ..............................................................................................47
3.0 The Patient Face Shields ....................................................................................................................... 48
3.1 How to Install or Remove the Conventional Face Shield ................................................................ 48
3.2 How to Install or Remove the Retractable Face Shield .................................................................... 49
3.3 How to Use the Retractable Face Shield ......................................................................................... 50
4.0 Compression Paddles ........................................................................................................................... 51
4.1 Routine Screening Paddles ............................................................................................................. 51
4.2 Contact and Spot Compression Paddles ......................................................................................... 51
4.3 Localization Paddles ...................................................................................................................... 52
4.4 Magnification Paddles .................................................................................................................... 52
4.5 How to Install or Remove a Compression Paddle ........................................................................... 53
4.6 Maintenance and Cleaning ............................................................................................................ 53
4.7 Paddle Shift .................................................................................................................................... 53
4.8 FAST Compression Mode ............................................................................................................... 54
5.0 Magnification Stand .............................................................................................................................. 55
5.1 How to Install and Remove the Magnification Stand ...................................................................... 55
6.0 Crosshair Devices ................................................................................................................................. 56
6.1 How to Install and Remove the Localization Crosshair Device ....................................................... 56
6.2 How to Use the Localization Crosshair Device .............................................................................. 56
6.3 How to Install and Remove the Magnification Crosshair Device ....................................................57
6.4 How to Align the Crosshair Device ................................................................................................ 57
Chapter 6—Clinical Procedures 59
1.0 Standard Workflow ............................................................................................................................... 59
2.0 Example Screening Procedure .............................................................................................................. 60
2.1 How to Position the Patient ............................................................................................................ 60
2.2 Set the Exposure Techniques .......................................................................................................... 60
2.3 How to Acquire the Exposure ......................................................................................................... 61
2.4 How to Automatically Store the Image ........................................................................................... 61
2.5 How to Accept a Rejected Image ................................................................................................... 61
2.6 How to Accept or Reject a Pended Image ...................................................................................... 61
Chapter 7—Maintenance and Cleaning 63
1.0 General Information ............................................................................................................................. 63
1.1 For General Cleaning ..................................................................................................................... 63
1.2 To prevent Possible Injury or Equipment Damage .......................................................................... 64
2.0 Acquisition Workstation ....................................................................................................................... 65
2.1 How to Clean the Preview Display ................................................................................................. 65
2.2 How to Clean the Touchscreen Display ......................................................................................... 65
2.3 How to Clean the Keyboard ...........................................................................................................65
2.4 How to Clean the Fingerprint Reader ............................................................................................. 65
Chapter 8—System Administration Interface 67
1.0 How to Use the Admin Screen ............................................................................................................. 67
2.0 How to Use the System Tools ............................................................................................................... 70
2.1 The Radiologic Technologist Manager ........................................................................................... 70

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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

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List of Figures

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

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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

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Preface
Intended Use

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.

2.0 System Capabilities


The system provides the user interfaces for the performance of screening and diagnostic
mammograms:
• Conventional mammography with a digital image receptor equivalent in size to large
mammography film.
• Tomosynthesis scan with a digital image receptor equivalent in size to large
mammography film (Tomosynthesis option).
• Conventional digital mammogram and tomosynthesis scan during one compression
(Tomosynthesis option).

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

4.0 Skills Needed for System Use


You must know how to do the following:
• Perform the trackball operations, like click, drag, and/or select
• Perform the touchscreen operations
• Select from menus
• Type information in text fields
• Select the options in the screens
• Select the entries from drop-down lists
• Use scroll bars

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Training Requirements

5.0 Training Requirements


Hologic™ does not accept the responsibility for injury or damage from wrong system
operation.
Make sure that you receive training on the Selenia Dimensions before use on patients.
Hologic training programs address MQSA training regulations for any Technologist or
Physician.
Refer to this manual for directions on how to use Selenia Dimensions.

6.0 Quality Control Requirements


The facilities in the United States must use the Quality Control Manual to create a Quality
Assurance and Quality Control program. The facility must create the program to meet the
requirements of the Mammography Quality Standards Act or to be accredited by ACR or
another accreditation body.
The facilities outside the United States can use the Quality Control Manual as a guide to
create a program to meet the local standards and regulations.

7.0 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.

8.0 Warnings, Cautions, and Notes


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

WARNING! Procedures that you must follow accurately to prevent


possible serious injury or death.

Warning: Procedures that you must follow accurately to prevent injury.

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.

Note… Notes indicate additional information.

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Terms and Definitions

9.0 Terms and Definitions


ACR American College of Radiology
AEC Automatic Exposure Control
Annotations Graphic or text marks on an image to indicate an area of interest.
Collimator Device at the x-ray tube to control the area of the receptor
that is exposed.
Combo Procedure An image acquisition procedure for which the system takes
a conventional mammography image and a tomosynthesis
scan during a single patient compression (Tomosynthesis
option).
Conventional Mammography Single projection x-ray images of views for screening and
diagnostic purposes.
Diagnostic Workstation Softcopy workstation for diagnoses from digital images.
DICOM Digital Imaging and Communications in Medicine
Gantry A part of the Selenia Dimensions that has the Detector,
Generator and x-ray Source, Positioning/Compression,
Power Distribution, and Accessories Subsystems.
Grid Element within the Digital Image Receptor that reduces
scatter radiation during the exposure.
HIS Hospital Information System
HTC™ High Transmission Cellular Grid
Image Receptor Assembly of x-ray detector, x-ray scatter reduction grid,
and carbon fiber cover.
MQSA Mammography Quality Standards Act
Notice Annotations and comments per image communicated
between Diagnostic Review Workstations, Technologist
Workstations, and Acquisition Workstations.
PACS Picture Archiving and Communications System. A
computer and network system for the transfer and archive
of digital medical images.
Pend A mark on the image to indicate the Technologist is not
positive about the image quality. Pended images must be
Accepted or Rejected before the procedure is closed.
Projection Images The group of x-ray images for tomosynthesis taken at
different projection angles through the breast
(Tomosynthesis option).
RIS Radiology Information System
ROI Region of Interest
SID Source to Image Distance
Tomosynthesis An imaging procedure which combines a number of
projections taken at different angles. The tomosynthesis
images can be reconstructed to show planes or slices
within the object (Tomosynthesis option).
UPS Uninterruptible Power Supply

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International Symbols

10.0 International Symbols


This section describes the International Symbols on the Selenia Dimensions.
Connection for a conductor different from the Protective
Potential Equalization
Earth for a direct connection between two or more pieces
terminal
of electrical equipment.
Protective Earth For the connection of the line cord ground or ground
terminal cable of the equipment and there is no other purpose.

Off Power disconnected from the main power source.

On Power connection to the main power source.

Only a part of the equipment is disconnected from the


Off
main power source.

Only a part of the equipment is connected to the main


On
power source.

Symbol that indicates separate removal for electrical and


WEEE
electronic equipment.

Dangerous Voltage Identifies an area of possible lethal voltage.

Manufacturer

Date of Manufacture

11.0 Document Standards


When prompted to add text, enter the text written in monospaced font exactly as
shown.

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Chapter 1—General Information
System Description

Chapter 1—General Information


1.0 System Description
Legend for Figure 1-1
1. Gantry
2. C-arm
3. Acquisition Workstation

Figure 1-1: Selenia Dimensions

2.0 Safety Information


Read and understand this manual before you use the system. Keep the manual available
during the patient 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 Selenia Dimensions has protective devices, but the Technologist must understand how
to safely use the system. The Technologist must remember the health hazards of x-rays.

2.1 General Safety


The Selenia Dimensions system is classified as CLASS I, TYPE B APPLIED PART, IPX0,
permanently connected equipment, continuous operation with short term loading per IEC
60601-1. There are no special provisions to protect the system from flammable anesthetics
or ingress of liquids.

WARNING! Lethal voltages exist inside of this system. Do not open any
of the panels.

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WARNING! Per North American electrical safety requirements, you


must use a Hospital Grade receptacle to provide a correct
Ground.

WARNING! Do not use the electrical equipment near flammable


anesthetics.

Warning: This device contains dangerous material. Return to Hologic all


material removed from service.

Warning: The user or the service personnel must correct problems before
the system is used.

Warning: The user must arrange for preventive maintenance by an


authorized service representative.

Warning: If a paddle touches possible infectious materials, call your


Infection Control Representative for decontamination
instructions.

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.

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2.2 Patient Safety

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: The C-arm movement has drive motors.

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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: Control the access to the equipment according to local


regulations for radiation protection.

2.3 Radiation Safety

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 Face Shield does not protect from radiation.

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.

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2.4 Data Loss

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.

2.5 Equipment Damage

Caution: Do not put any heat source on the image receptor.

Caution: To minimize possible damage from thermal shock to the Digital Image
Receptor, follow the recommended procedure to turn off the
equipment.

Caution: Do not make any brightness or contrast adjustments to the display


unless the SMPTE test pattern is on the screen.

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.

2.6 Emergency Off Switches


The Emergency Off switches remove the power from the Gantry. Do not normally use the
Emergency Off switches to turn off the system. See Chapter 2, page 23 for complete
information.

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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.

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Chapter 1—General Information
Compliance

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

3.1 Compliance Requirements


The manufacturer has the responsibility for the safety, reliability, and performance of this
equipment with the following provisions:
• The electrical installation of the room meets all requirements.
• 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.
The complete system (network and communications equipment and Selenia Dimensions
Mammography System) must be in compliance with IEC 60601-1 and IEC 60601-1-1.

3.2 Compliance Statements


The manufacturer states this device is made to meet the following requirements:
• CAN/CSA ISO 13485:2003
• EN 60601-1:1990 +A1+A11+A12+A2+A13 Medical Electrical Equipment—General
Requirements for Basic Safety and Essential Performance
• FDA, 21 CFR [Parts 820, 900 and 1020]
• IEC 60601-1:1988 +A1+A2:1995 +A13:1996 Medical Electrical Equipment—General
Requirements for Safety
• IEC 60601-1-1:2000-12 Medical Electrical Equipment—Collateral Standard: Safety
Requirements for Medical Electrical Systems
• IEC 60601-1-2:2001 Medical Electrical Equipment—Collateral Standard:
Electromagnetic Compatibility for Medical Electric Systems
• IEC 60601-1-3:1994 Medical Electrical Equipment—Collateral Standard: Requirements
for Radiation Protection in Diagnostic X-ray Equipment
• IEC 60601-1-4:1996 +A1:1999 Medical Electrical Equipment—Collateral Standard:
Programmable Electrical Medical Systems
• IEC 60601-2-7:1998 Medical Electrical Equipment—Particular Requirements for the
Safety of High-Voltage Generators of Diagnostic X-ray Equipment
• IEC 60601-2-28:1993-03 Medical Electrical Equipment—Particular Requirements for the
Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis
• IEC 60601-2-32:1994 Medical Electrical Equipment—Particular Requirements for the
Safety of Associated Equipment of X-ray Equipment
• IEC 60601-2-45:2001 Medical Electrical Equipment—Particular Requirements for the
Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices
• UL 60601-1: Medical Electrical Equipment, Part 1—General Requirements for Safety
• CAN/CSA: Medical Electrical Equipment Part 1: C22.2 No. 601.1–M90—General
Requirements for Safety

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Chapter 1—General Information
Label Locations

4.0 Label Locations

Figure 1-2: Label Locations

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Chapter 2—System Controls and Indicators
System Power Controls

Chapter 2—System Controls and Indicators


1.0 System Power Controls

Figure 2-1: System Power Controls

Legend for Figure 2-1


1. Gantry Power Circuit Breaker
2. Emergency Off Switch (two on the Gantry, one on the Acquisition Workstation)
3. Acquisition Workstation Power Circuit Breaker
4. Computer Power Button
5. UPS Power Button

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Acquisition Workstation Controls and Display

2.0 Acquisition Workstation Controls and Display

Figure 2-2: Acquisition Workstation Controls and Displays

Legend for Figure 2-2


1. Trackball
2. Scroll Wheel
3. Compression Release
4. Emergency Off Switch
5. Fingerprint Reader
6. X-ray Button (one on each side)
7. Touchscreen Display
8. Keyboard (in drawer)
9. CD/DVD Drive
10. Bar Code Reader
11. LED for Preview Display Power
12. Preview Display

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2.1 Keyboard
Use the keyboard in the front drawer of the Acquisition Workstation for data entry.

2.2 Bar Code Reader


Use this device for data entry from bar codes for patient or procedure records.

2.3 Acquisition Workstation Touchscreen Display


Use the Touchscreen or trackball to select items.

2.4 Preview Display


See the images on the Preview Display.

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Tubestand Controls and Indicators

3.0 Tubestand Controls and Indicators

Legend for Figure 2-3


1. The Rotation Angle Displays (each side)
2. The C-arm Controls (each side)
3. The Compression Device
4. The Patient Handles (each side)
5. The Emergency Off Switches (each side)
6. The Compression Handwheels
7. The Patient Face Shield
8. The Tubehead Display
9. The Footswitches

Figure 2-3: Tubestand Controls and Indicators

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3.1 C-arm Controls

The C-arm Controls provide the


Collimator and C-arm functions.
See Section 5.0, page 17.

Figure 2-4: C-arm Controls

3.2 Compression Device Controls and Displays

Legend for Figure 2-5


1. Manual Compression Handwheels
POSITAEC
ION

2. Paddle Shift Buttons


3. AEC Buttons
4. Compression Device Display
5. The FAST Compression Mode Slide
6. Paddle Clamp

Figure 2-5: Compression Device

The Display on the compression


device shows:
• AEC Sensor Position
• Compression Force (displays 0.0
when force is less than 4 pounds)
• Compression Thickness
• Angle of C-arm after rotation (for
10 seconds)

Figure 2-6: Compression Display

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3.3 Tubehead Display

The Tubehead Display shows:


• SID
• Filter Type
• Collimator Setting
• Paddle Position

cm Rh
SID: 70 9 C
x2
Coll: 24

Figure 2-7: Tubehead Display

3.4 Dual Function Footswitches

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.

To use the footswitches:


1. Press the footswitch to actuate.
2. Release the switch to stop the COMPR
M ESSION
movement. C-AR

Legend for Figure 2-8


1. C-arm Down
2. C-arm Up
3. Compression Down
4. Compression Up

Figure 2-8: Dual Function Footswitches

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How to Turn On the Selenia Dimensions

4.0 How to Turn On the Selenia Dimensions


4.1 Preparation
1. Reset all three Emergency Off switches.
2. Make sure that both system circuit breakers are in the On position.
3. Remove any obstructions to the C-arm movement and to the view of the Operator.

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).

Figure 2-9: The Startup Screen

3. Select the Log In button.

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.

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4.3 Log In

Figure 2-10: How to 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.

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Chapter 2—System Controls and Indicators
Perform the Functional Tests

5.0 Perform the Functional Tests

Legend for Figure 2-11


1. Compression Release
2. (Future use)
3. Light Field Lamp
4. (Future use)
5. Collimator Override
6. Clockwise C-arm Rotation
7. C-arm Up and Down
8. Counterclockwise C-arm
Rotation
9. Compression Up
10. Compression Down

A C-arm control panel is on


both the left and right sides Figure 2-11: C-arm Controls (left side shown)
of the Gantry.

The following Functional Tests make sure that the control operates correctly.

Table 2-1: C-arm Functional Tests

Function Functional Test

Compression Down Press a Compression Down button:


• The compression brake engages.
• The light field lamp illuminates.
• The compression device lowers.
Note… When you press the Compression Down button, the
compression brake remains engaged until the Compression
Release button is pressed.
Compression down movement stops:
• When you release the button.
• When you reach the Down Force limit.
• When you reach the Lower Travel limit.

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Table 2-1: C-arm Functional Tests

Function Functional Test

Compression Up Press a Compression Up button:


• The Compression Device moves toward the top.
• The Compression Up button does not release the
Compression Brake.
Compression Up movement automatically stops:
• When you release the button.
• When you reach the upper travel limit.

Compression Release Press the Compression Release button:


• The Compression Motor Brake releases.
• The Compression Device lifts.

C-arm Up Press the C-arm Up button:


• The C-arm movement automatically stops when the
button is released.
• The C-arm movement automatically stops when the
C-arm reaches the upper travel limit.
• The C-arm movement is disabled when a compression
force of 45 N (10 pounds) or greater is applied.

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Table 2-1: C-arm Functional Tests

Function Functional Test

C-arm Down Press the C-arm Down button:


• The C-arm movement automatically stops when the
button is released.
• The C-arm movement automatically stops when the
C-arm reaches the lower travel limit.
• The C-arm movement is disabled when a compression
force of 45 N (10 pounds) or greater is applied.

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Table 2-1: C-arm Functional Tests

Function Functional Test

Counterclockwise C-arm Press the Counterclockwise C-arm Rotation to start


Rotation counterclockwise C-arm rotation.

Left Panel Right Panel

Clockwise C-arm Rotation Press the Clockwise C-arm Rotation button to start
clockwise C-arm rotation.

Left Panel Right Panel

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Table 2-1: C-arm Functional Tests

Function Functional Test

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.

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Table 2-1: C-arm Functional Tests

Function Functional Test

Collimator Override The Collimator Override button changes the collimation


through the different x-ray fields.
Press the light field lamp button to show the x-ray field, then
press the Collimator Override button to select an x-ray field.

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.

Motor Enable Reserved for future use.

C-arm Zero Reserved for future use.

Shifting Paddle The 18 x 24-cm Screening Paddle moves approximately 2.5


System cm into the left, center, or right position. While the
AEC
POSITION

compression is applied, you can not move the paddle. The


collimator is programmed to follow the position of the
paddle.
To test this function:
1. Install the 18 x 24-cm paddle in the Compression
Device.
2. Select a view. Use the Paddle Shift buttons on the
procedure screen to override the position.
Verify that the paddle automatically moves to the new
position.
3. Turn on the light field lamp. Confirm that the collimator
position matches the paddle position.
4. Repeat this procedure for the other paddle positions.
A FAST Compression Mode Slide on the Compression
Device lets you set the system for FAST Mode or for Normal
Mode.
To select the mode, move the Slide to the “F” position from
either side of the Compression Device. The default shift
positions are configurable through Service Tools.

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How to Turn Off the System

Table 2-1: C-arm Functional Tests

Function Functional Test

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.

6.0 How to Turn Off the System


1. Close any open patient procedures.
2. From the Select Patient screen, select the Log Out button.
3. From the Select an Operator screen, select the Exit button.
4. From the Startup screen, select the Shutdown button.
5. Select the Yes button in the confirmation screen.

7.0 How to Remove All Power from the Acquisition Workstation


Perform the procedures in this section after shutdown of the Acquisition Workstation.

Figure 2-12: Power Buttons

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.

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Chapter 3—The User Interface
Select the Function to Perform

Chapter 3—The User Interface


1.0 Select the Function to Perform
After you log in, the Select Function to Perform screen displays.

Note… The Select Patient screen appears if you are not scheduled to perform
any Quality Control tasks.

Figure 3-1: An Example Select Function to Perform Screen

1. Select an item in the list.


2. Select the Start button or the Mark Completed button. The Start button is not available
for all types of tests.
3. Follow the messages to complete the procedure.
If all Quality Control tasks will not be performed at this time, you can select the Skip button.

Note… If you select the Skip button, the Select Patient screen appears.

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2.0 How to Perform the Quality Control Tasks


1. Select a Quality Control task from the Select Function to Perform screen.
2. Select the Start button.
3. Follow the on-screen prompts to complete the procedure.

Figure 3-2: An Example Gain Calibration Screen

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.

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3.0 How to Select a Patient

Figure 3-3: How to Select a Patient

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).

3.1 How to Open a Procedure


1. When you select a patient from the list in any of the tabs, the Open button activates.
2. When you select the Open button, the Procedure screen for that patient appears.

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3.2 How to Add a New Patient


1. In the Select Patient screen, select the New button.
2. Enter new patient information and select a procedure.
3. Select the Open button. A screen for the new patient information appears.

Figure 3-4: How to Add a New Patient

3.3 How to Edit the Patient Information


1. In the Select Patient screen, select the patient name then select the Edit button.
2. In the Edit Patient screen, make changes then select the Save button.
3. When the Update Successful screen displays, select the OK button.

3.4 How to Delete a Patient


1. In the Select Patient screen, select one or more patients.
2. Select the Delete button.
3. To the Confirmation Required prompt, select Yes.

Note… The Technologists do not have the user permission to delete patients.

Note… Reclamation normally removes the requirement to delete patients.

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3.5 How to Use a Patient Filter


When you select the Filter button in the Select Patient screen, the Patient Filter screen for the
selected tab appears. See Figure 3-5.

Figure 3-5: The Filter Tab in the Patient Filter Screen

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.

3.6 How to Refresh the Worklist


Select the Refresh Worklist button to update the screen.

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3.7 How to Query the Worklist


Use the Query Worklist feature to search for a patient or a list of patients.
There are two methods to enter the query information:
• Bar Code Reader—The field in which the bar code reader scans is configurable. Scan
the configured field bar code. The scheduled procedure displays and the patient is
added to the local database. By default, the user can scan on the Patient ID, Accession
Number, or Requested Procedure ID.
• Keyboard—Use one or more fields to query the Modality Worklist Provider. All fields to
query are configurable. The default fields are as follows: the Patient name, the Patient ID,
Accession Number, Requested Procedure ID, Scheduled Procedure Date. The scheduled
procedure displays and the patient is added to the local database.

3.8 About the Admin Button


See “Chapter 8—System Administration Interface,” page 67.

3.9 How to Log Out


Select the Log Out button to return to the Startup screen.

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4.0 The Procedure Screen


Select the Generator tab (at the top of the screen on the left side) to adjust the exposure
techniques for the procedure. Select the options in the Tools tab (at the top of the screen on
the left side) for image review (see Chapter 4, Section 2.0, page 42).

Figure 3-6: An Example Generator Tab in the Procedure Screen

4.1 How to Set the Exposure Parameters


4.1.1 Select the Image Acquisition Mode (Tomosynthesis option)
• Standard For routine Tomosynthesis screening procedures
• Enhanced For diagnostic views. This mode increases the patient dose.

4.1.2 Select the Exposure Mode


• Manual The user selects the kV, mAs, Focal Spot, and Filter.
• AEC: Auto-Time The user selects the kV, Focal Spot, and Filter. The system
selects the mAs.
• AEC: Auto-kV The user selects the Focal Spot. The system selects the kV,
mAs, and Filter (Rhodium).
• AEC: Auto-Filter The user selects the Focal Spot. The system selects the kV,
mAs, and Filter.
Use the Automatic Exposure Control modes (AEC) to let the system control the
exposure techniques.

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4.1.3 How to Use the AEC Sensor


The AEC Sensor has seven manual positions and an automatic position. The manual
positions start at the chest wall edge (position 1) and reach to the nipple edge
(position 7). The automatic position is Position 8.
Use the plus (+) and minus (-) keys on the Compression Device or in the AEC Sensor
area of the screen to change the sensor position. You can select Auto AEC to allow
the system to calculate the best exposure for the breast.

4.2 How to Use the Implant Present Button


The Implant Present button is above the Accept button on the
Procedure screen. This button applies special implant processing
to the implant and the implant displaced views, and changes the
“Implant Present” DICOM tag in the image header. When this
button is selected, a checkmark appears on the button.
Select the Implant Present button for both implant and implant displaced views before you
acquire the image.

Note… The Implant Present button is automatically selected if there is an ID


view in the open procedure.

4.3 How to Acquire an Image


See Chapter 6, page 59 for information about clinical procedures.
1. Select a view from the thumbnail images at the bottom of the screen.
2. Press and hold the x-ray button for the complete exposure. During the exposure, a
System Message appears, a tone sounds, and the x-ray indicator on the control panel
lights to indicate x-ray emission.
3. The image displays when the x-ray is complete. You must select how to complete the
acquisition.
• You can Accept the image. The locked image transmits to output devices with all
attributes and marks.
• You can Reject the image. The Preview closes. You can repeat the rejected view, or
select another view.
• You can Pend the image. The image saves for future review.
4. Repeat the steps 1 to 3 for each view.

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4.4 How to Add or Remove a View


1. To add a view, select the Add View button to display the Add View screen.

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

Figure 3-7: The Add View Screen

Note… ID indicates Implant Displaced.


2. Select the tab, then select the view. You can select a maximum of 3 View Modifiers from
the right panel of the screen.
3. Select the Add button. A thumbnail image for each view that you select appears in the
bottom of the window.
4. To remove a selected view, select the view then select the TRASH icon.
5. To remove all selected views, select the Clear button.

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4.5 How to Add a Procedure


1. To add another procedure, select the Add Procedure button on the Procedure screen to
display the Add Procedure dialog box.

Figure 3-8: The Add Procedure Dialog Box

2. Use the drop-down menus to select the type of procedure to add.


3. Enter an Accession Number or select the “Inherit Accession Number” checkbox to use
the current number.
4. Select the OK button. A new tab displays with the thumbnail images for the procedure
which was added.

4.6 How to Edit a View


Use the Edit View screen to assign a different view to an image.

Figure 3-9: The Edit View Screen


To edit a view:
1. Select an exposed thumbnail image view in the Procedure screen.
2. Select the Edit View button.
3. Select the view from the screen. You can select a maximum of 3 View Modifiers. See
Figure 3-7 for a description of the View Modifiers.
4. Select the Save button.
5. When the Update Successful screen displays, select the OK button.

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4.7 How to Close a Procedure


Select the Close Patient button. If you acquired images, a Close Procedure dialog box
displays. Select one of the following options:
• Close Procedure Complete Closes the procedure and puts the procedure in the
Complete tab.
• Close Procedure In Progress Closes the procedure and puts the procedure in the In
Progress tab.
• Close Procedure Closes the procedure and puts the procedure in the
Discontinued Discontinued tab. A dialog box appears and you must
select the reason the procedure was discontinued from a
list or add a new reason.
• Return To procedure Returns to procedure.
If there are images marked as Pend, you must respond to the confirmation prompt to close
the procedure In-Progress.
If MPPS is activated, messages are sent to the output devices when you select Complete and
Discontinue. You can also click and hold the tab above the thumbnail images to resend a
message about the procedure status during the procedure. A Procedure Action dialog box
appears with buttons to resend a status or to return to the procedure.

5.0 How to Access Image Review Features


Select the Tools tab on the Procedure screen to access the image review features. See
Chapter 4, Section 2.1, page 43 for information.

6.0 How to Use the Output Sets


The Accepted images are sent automatically to the output devices in the selected Output Set.
The default values for the site control if the images are sent after a patient is closed or after
the image is Accepted.

6.1 How to Select an Output Set


Select an output device set like PACS, Diagnostic Workstations, CAD devices and printers
from the Output Set drop-down menu in the Procedure screen.

Note… Images are not sent if an Output Set is not selected.

6.2 How to Add or Edit an Output Set

Note… The configuration of Output Groups (Sets) is done during installation,


but you can add other groups (Sets).
To add a new Output Set:
1. Access the Admin screen.
2. Select the Manage Output Groups button.
3. Select the New button, enter the information, then select the output device.
4. Select the Add button. When the Update Successful message displays, select OK.

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To edit an Output Set:


1. Access the Admin screen.
2. Select the Manage Output Groups button.
3. Select the Edit button, then make the changes.
4. Select the Save button. When the Update Successful message displays, select OK.

7.0 How to Use the On-Demand Outputs


You can manually Archive, Print, or Export an image until the procedure is closed.
When you press an On-Demand output button, you have the option to send the image to any
of the configured Output Sets.

7.1 How to Archive


1. Select the Archive button.
2. Select a storage device from a drop-down menu.
3. Select the Start button to copy all selected images from the opened case study to the
selected device.

Note… Use the Manage Queue utility in the task bar to review the image
status.

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7.2 How to Print


7.2.1 The Print Screen

Figure 3-10: The Print Screen

Legend for Figure 3-10


1. Mirrors the image.
2. Selects the film format (number of tiles).
3. Prints Conventional images with the default setup.
4. Prints tomo images (slices or projections) that have been Tagged for Print
(Tomosynthesis option).
5. Returns the screen to previous settings.
6. Opens the Properties screen.
7. Shows the printer IP address, AE Title, Port and capability for True Size print.
8. Starts the print process.
9. Returns you to the Procedure screen.
10. Selects the printer options.
11. Allows you to step through the film pages.
12. Selects Conventional, Projection, or Reconstruction views (Tomosynthesis option).
13. Shows the Thumbnail image view.

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7.2.2 How to Use the Print Screen


1. From the Procedure screen, select the Print button. The Print Screen displays.
Refer to Figure 3-10 to prepare your print information.
2. Select the film format from the Options area of the page.
3. Select a thumbnail image.
4. Select the image display box on the right side of the screen to put the selected
thumbnail image on the film.
5. To put other thumbnail images on the film, repeat steps 2 and 3.
6. To print a different film format of the same images, select the New Film button
and repeat steps 1 to 4.
7. Select the Print button to print your films.

7.3 How to Export


1. Select the Export button.
2. Select a device from a drop-down menu.
3. Select the Start button to copy all accepted images from the open procedure to the
selected device.

8.0 How to Use the Paddle Shift Feature


1. In the Procedure screen, select an unexposed thumbnail image view. The paddle moves
to the default position.

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.

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Chapter 3—The User Interface
About the Taskbar

9.0 About the Taskbar


The taskbar at the bottom of the screen displays additional icons, which you can select to
access information or perform system tasks.

Table 3-1: Taskbar Menus

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.

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Chapter 4—The Images
Introduction

Chapter 4—The Images


1.0 Introduction
After you make an exposure, the acquired image displays on the Preview screen. Review the
image and add the annotations, then Accept, Reject, or Pend the image. A thumbnail image
appears in the Case Study area of the screen.
• If you select the Reject button, an “X” appears on the thumbnail image.
• If you select the Pend button, a question mark “?” appears on the thumbnail image.

Figure 4-1: The Preview Screen

1.1 Conventional Sequence of Events


• Review the image after the exposure.
• Accept, Reject, or Pend the image.

1.2 Tomosynthesis Sequence of Events (Tomosynthesis option)


• Wait for the image reconstruction to complete.
• Review a few slices from the reconstruction.
• Accept, Reject, or Pend the images.

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2.0 How to Review the Images

Figure 4-2: The Tools Tab in the Procedure Screen

Select any thumbnail image to display that image in the Preview screen. The thumbnail
image is marked if the image is not accepted.

Figure 4-3: Marked Images in a Procedure

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2.1 The Image Review Tools Tab


The Tools tab in the Procedure screen provides the image review tools. A checkmark appears
on the button of an active tool.

Figure 4-4: Image Review Tools

Legend for Figure 4-4


1. The Zoom tool magnifies a section of the image.
2. The Window Level tool with the Trackball changes the brightness and contrast.
3. The Window Level Fine Adjustment tool enters the specified contrast and brightness values.
4. The Crosshair tool displays a crosshair on the Preview Screen.
5. The SNR/CNR button calculates the signal-to-noise ratio and contrast-to-noise ratio in the ACR
Phantom image.
6. The AEC button displays the AEC Sensor areas used for the exposure calculation. The sensor areas
display on the Preview Screen.
7. The Patient Information button activates the patient information display.
8. The Ruler displays a measurement of the distance between two points.
9. The Fit-to-Viewport button fits the image within the image tile.
10. The True Size button displays the image in the actual size of the breast.
11. The View actual pixels button displays the image in full resolution.
12. The Multi-Up Display button selects the number of tiles to display.
13. The Image Tile Advance button sets the active Multi-Up tile.
14. The Mirror button reverses (mirrors) the image.
15. The Tag for Print button tags the projection or reconstruction images of a tomosynthesis image to
print later (Tomosynthesis option).

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2.2 Other Image Review Tools


2.2.1 The Image Review Tabs
Each tab provides additional image review functions.

Figure 4-5: Image Review Tabs

• Cine: Show a series of images as a movie (Tomosynthesis option).


• Notices: Make annotations about the image. Use the Draw or Elliptical button
(Numbers 1 and 2) in Figure 4-6 to mark the area of interest. Use the Arrow
button (Number 3) to send the annotation as a Notice.

Figure 4-6: Icons Available on the Notices Tab

• Comments: Add comments.


• Service: Mark an image for service use.
• ROI: Draw a Region of Interest on the image display.

2.2.2 The Exposure Index

Figure 4-7: The Exposure Index

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.

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2.2.3 Display Modes (Tomosynthesis option)


Use the CONV, PRJ, and REC buttons to select the type of view to display in the
Preview Screen. You can change between CONV (conventional), PRJ (projections),
and REC (reconstruction) to display the combination images.
• Use CONV (conventional) to display conventional images.
• Use PRJ (projections) to display the 15 projections.
• Use the REC (reconstruction) to display the reconstructed slices.

2.3 How to Correct and Reprocess Implant Images


You must correct the image if you acquire an implant or an implant displaced view without
the Implant Present button activated.
2.3.1 If You Did Not Accept the Image:
Select the Implant Present button on the
Procedure screen to indicate an implant exists.
A checkmark appears on the button and the
image reprocesses.

2.3.2 If You Accepted the Image:


1. Re-preview the image.
2. Select the Implant Present button on the Procedure screen to correct the image.
A checkmark appears on the button and the image reprocesses.
3. Select Accept to accept the changes.

Note… The corrected image is automatically sent to the selected output


devices.

3.0 Send the Images to the Output Devices


You can send the images to output devices or use the Export function to copy images to a
temporary storage device. See Chapter 3, Section 6.0, page 35 and Section 7.0, page 36 for
instructions.

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Chapter 5—How to Use the Accessories
Introduction

Chapter 5—How to Use the Accessories


1.0 Introduction
The Selenia Dimensions can perform screening or diagnostic applications with specified
accessories. This chapter describes how to use all possible system accessories. Your
accessories depend on your system configuration.

2.0 How to Install Accessories on the C-arm


The Retractable Face Shield, Magnification Stand, and Localization Crosshairs are installed
in slots on the C-arm. The slots have labels with icons to indicate the accessory that attaches
in the slot. Each accessory has two lines. Align the accessory with the related line on the C-
arm. When the hook on the accessory is at the correct depth, the second, thinner line aligns
with the line on the C-arm.
The next sections contain installation instructions for each accessory.

Figure 5-1: C-arm Accessories

Legend for Figure 5-1


1. Slot for Retractable Face Shield (Tomosynthesis option)
2. Slot for 1.8x Mag Stand
3. Slot for 1.5x Mag Stand

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The Patient Face Shields

3.0 The Patient Face Shields


The Face Shield keeps the head and face of the patient away from the x-ray field during the
examination. Inspect the shield each day before use.

Warning: The Face Shield must be attached for all exposures except
magnification case studies.

Warning: The Face Shield does not protect from radiation.

3.1 How to Install or Remove the Conventional Face Shield

Figure 5-2: How to Install the Conventional Face Shield

See Figure 5-2 to install the Conventional Face Shield:


1. Carefully put the tab ends of the Face Shield (Number 1 in the Figure) into the slots at the
front of the tubehead mount.
2. Slide the Face Shield on the tubehead mount until the Face Shield locks.
To remove the Conventional Face Shield:
1. Pull the sides of the Face Shield in a horizontal direction (away from the tubehead).
2. Remove the Face Shield.

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3.2 How to Install or Remove the Retractable Face Shield


To install the Retractable Face Shield, see Figure 5-4, page 50:
1. Completely extend the Face Shield to the outer position.
2. Align the hooks of the Face Shield with the mounting slots on the C-arm, indicated by a
face shield icon.
3. Put the hooks on both sides of the Face Shield into the mounting slots on the C-arm. The
Unlock Lever (number 1, Figure 5-4) will be in the Up position.
4. Push the Face Shield to the down and locked position. The Unlock Lever is in the down
position when the Face Shield locks.

Figure 5-3: How to Align the Retractable Face Shield on the C-arm

To remove the Retractable Face Shield:


1. Press and hold the Unlock Lever (number 1, Figure 5-4) in the Up position.
2. Lift the Face Shield from the slots and remove from the C-arm.

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The Patient Face Shields

3.3 How to Use the Retractable Face Shield


1. Always completely extend the Face Shield before an exposure.
2. To extend the Face Shield, pull the shield away from the C-arm until the device latches
in the outer position.
To retract the Face Shield
1. Press one of the Latch Release buttons (number 2, Figure 5-5—one on each side).
2. Push the Face Shield toward the C-arm until the device stops.

Figure 5-4: Installation Figure 5-5: Operation

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Compression Paddles

4.0 Compression Paddles


The system can identify each paddle and automatically adjust the collimator.

4.1 Routine Screening Paddles

18 x 24 cm Frameless 24 x 29 cm Frameless Small Breast Frameless


Screening Paddle Screening Paddle Paddle

4.2 Contact and Spot Compression Paddles

7.5 cm Spot Contact Spot Contact


Frameless Paddle Frameless Paddle

10 cm Contact 15 cm Contact
Frameless Paddle Frameless Paddle

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4.3 Localization Paddles

10 cm Rectangular Opening 15 cm Rectangular Opening


Localization Paddle Localization Paddle

10 cm Perforated 15 cm Perforated
Localization Paddle Localization Paddle

4.4 Magnification Paddles

7.5 cm Spot Magnification 10 cm Magnification


Paddle Paddle

10 cm Magnification 15 cm Magnification
Localization Perforated Paddle
Paddle

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4.5 How to Install or Remove a Compression Paddle


See Figure 5-6 to install a Compression Paddle:
1. Hold the front of the paddle with one hand in front of the Compression Device.
2. Tilt the paddle (between 30 and 45 degrees), then put the rear of the paddle on the
groove in the rear of the Compression Device (Number 1).
3. Slide the paddle along the groove until the slots on the top of the paddle are under the
locks on the Paddle Clamp (Number 2).
4. Compress the Paddle Clamp (Number 3) with your free hand.
5. Rotate the paddle up (Number 4), then release the Paddle Clamp to lock the paddle.

Figure 5-6: How to Install a Compression Paddle

See Figure 5-7 to remove the Compression Paddle:


1. Hold the paddle with one hand while you use the free hand to compress the Paddle
Clamp to release the lock (Number 1).
2. Lower the paddle (Number 2) and remove the paddle from the Compression Device
(Number 3), then release the Paddle Clamp.

Figure 5-7: How to Remove the Compression Paddle

4.6 Maintenance and Cleaning


Clean the paddles after each use. See Chapter 7, page 63 for cleaning instructions.

4.7 Paddle Shift


The system allows most paddles to move to the left or right of the center position. The feature
helps small-breast examinations with lateral views. When a lateral view is selected, the
system automatically moves the collimator for the selected paddle position.

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4.8 FAST Compression Mode


4.8.1 How the FAST Compression Mode Works
The Fully Automatic Self-adjusting Tilt (FAST) Compression Mode is for use when
the composition of the breast tissue does not allow uniform compression across the
complete breast with a flat compression paddle. For these patients, not enough
compression can cause an image to appear to be out of focus at the anterior region
from both involuntary motion and not enough compression.
The FAST Compression mode used with this type of breast provides these features:
• Reduced motion artifacts, because the compression is more effective.
• The compression is more uniform from the chest wall to the nipple.
• Maximum patient comfort, because over compression at the chest wall is
prevented.
When the FAST Compression mode is selected, the paddle automatically tilts when
the compression is applied. The paddle starts at the flat position until some
compression force is applied. The paddle then tilts until its maximum angle is
reached.
The FAST Compression mode does not require excessive compression, but you must
use enough compression to prevent the movement of the breast. You should use a
consistent amount of compression, especially for related left and right views.
The FAST Compression mode may not be best for breasts that are equal or
symmetrical in thickness from the chest wall to the anterior area of the breast.

4.8.2 How to Use the FAST Compression Mode Slide


To engage the FAST Compression Mode, push the slide (from either side) until the
“F” is visible and the slide clicks into position.

Figure 5-8: The FAST Compression Mode Slide

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