mammography unit selenia dimensions (3d) - user manual

8/18/2019 Mammography Unit Selenia Dimensions (3D) - User Manual

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Technical Support:

USA: +1.877.371.4372

Europe: +32.2.711.4690

Asia: +852 37-48-77-00

All Other: +1.781.999.7750

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

Selenia Dimensions User Manual

Part Number MAN-01964Revision 001

July 2010

Corporate Headquarters

35 Crosby Drive,Bedford, MA 01730-1401 USATel: +1.781.999.7300Sales: +1.781.999.7453Fax: +1.781.280.0668www.hologic.com

Europe(EU Representative)

Hologic NVLeuvensesteenweg 250A1800 Vilvoorde, BelgiumTel: +32.2.711.4680Fax: +32.2.725.2087

Refer to the corporate website for more facilities worldwide.


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DRAFT Preview copy—Generated 7/9/2010

User ManualTable of Contents

Table of Contents

List of Figures ixList of Tables xi

Preface xiii

1.0 Intended Use .......................................................................................................................................xiii2.0 System Capabilities ..............................................................................................................................xiii3.0 Users ...................................................................................................................................................xiii4.0 Skills Needed for System Use .............................................................................................................. xiii5.0 Training Requirements ......................................................................................................................... xiv6.0 Quality Control Requirements ............................................................................................................. xiv7.0 Hologic Cybersecurity Statement ......................................................................................................... xiv

8.0 Warnings, Cautions, and Notes ........................................................................................................... xiv9.0 Terms and Definitions .......................................................................................................................... xv10.0 International Symbols ........................................................................................................................ xvi11.0 Document Standards ......................................................................................................................... xvi

Chapter 1—General Information 1

1.0 System Description .................................................................................................................................12.0 Safety Information ..................................................................................................................................1

2.1 General Safety ..................................................................................................................................12.2 Patient Safety ...................................................................................................................................32.3 Radiation Safety ...............................................................................................................................42.4 Data Loss .........................................................................................................................................52.5 Equipment Damage ..........................................................................................................................5

2.6 Emergency Off Switches ...................................................................................................................52.7 Interlocks .........................................................................................................................................6

3.0 Compliance ............................................................................................................................................73.1 Compliance Requirements ...............................................................................................................73.2 Compliance Statements ....................................................................................................................7

4.0 Label Locations ......................................................................................................................................8

Chapter 2—System Controls and Indicators 9

1.0 System Power Controls ...........................................................................................................................92.0 Acquisition Workstation Controls and Display ......................................................................................10

2.1 Keyboard .......................................................................................................................................112.2 Bar Code Reader ............................................................................................................................112.3 Acquisition Workstation Touchscreen Display ...............................................................................112.4 Preview Display .............................................................................................................................11

3.0 Tubestand Controls and Indicators ........................................................................................................123.1 C-arm Controls ...............................................................................................................................133.2 Compression Device Controls and Displays ...................................................................................133.3 Tubehead Display ..........................................................................................................................143.4 Dual Function Footswitches ...........................................................................................................14

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4.0 How to Turn On the Selenia Dimensions ............................................................................................. 154.1 Preparation .................................................................................................................................... 154.2 Startup ........................................................................................................................................... 154.3 Log In ............................................................................................................................................ 16

5.0 Perform the Functional Tests ................................................................................................................ 176.0 How to Turn Off the System ................................................................................................................. 237.0 How to Remove All Power from the Acquisition Workstation .............................................................. 23

Chapter 3—The User Interface 25

1.0 Select the Function to Perform ............................................................................................................. 252.0 How to Perform the Quality Control Tasks ........................................................................................... 263.0 How to Select a Patient ........................................................................................................................ 27

3.1 How to Open a Procedure ............................................................................................................. 273.2 How to Add a New Patient ............................................................................................................ 283.3 How to Edit the Patient Information ............................................................................................... 283.4 How to Delete a Patient ................................................................................................................ 283.5 How to Use a Patient Filter ............................................................................................................ 29

3.6 How to Refresh the Worklist .......................................................................................................... 293.7 How to Query the Worklist ........................................................................................................... 303.8 About the Admin Button ................................................................................................................ 303.9 How to Log Out ............................................................................................................................ 30

4.0 The Procedure Screen .......................................................................................................................... 314.1 How to Set the Exposure Parameters .............................................................................................. 314.2 How to Use the Implant Present Button ......................................................................................... 324.3 How to Acquire an Image .............................................................................................................. 324.4 How to Add or Remove a View ..................................................................................................... 334.5 How to Add a Procedure ............................................................................................................... 344.6 How to Edit a View ....................................................................................................................... 344.7 How to Close a Procedure ............................................................................................................. 35

5.0 How to Access Image Review Features ................................................................................................ 356.0 How to Use the Output Sets ................................................................................................................. 35

6.1 How to Select an Output Set ......................................................................................................... 356.2 How to Add or Edit an Output Set ................................................................................................. 35

7.0 How to Use the On-Demand Outputs .................................................................................................. 367.1 How to Archive ............................................................................................................................. 367.2 How to Print .................................................................................................................................. 377.3 How to Export ............................................................................................................................... 38

8.0 How to Use the Paddle Shift Feature .................................................................................................... 389.0 About the Taskbar ................................................................................................................................ 39

Chapter 4—The Images 41

1.0 Introduction ......................................................................................................................................... 41

1.1 Conventional Sequence of Events .................................................................................................. 411.2 Tomosynthesis Sequence of Events (Tomosynthesis option) ........................................................... 412.0 How to Review the Images .................................................................................................................. 42

2.1 The Image Review Tools Tab ......................................................................................................... 432.2 Other Image Review Tools ............................................................................................................ 442.3 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 ..........................................................................................................................................472.0 How to Install Accessories on the C-arm ..............................................................................................47

3.0 The Patient Face Shields .......................................................................................................................483.1 How to Install or Remove the Conventional Face Shield ................................................................483.2 How to Install or Remove the Retractable Face Shield ....................................................................493.3 How to Use the Retractable Face Shield .........................................................................................50

4.0 Compression Paddles ...........................................................................................................................514.1 Routine Screening Paddles .............................................................................................................514.2 Contact and Spot Compression Paddles .........................................................................................514.3 Localization Paddles ......................................................................................................................524.4 Magnification Paddles ....................................................................................................................524.5 How to Install or Remove a Compression Paddle ...........................................................................534.6 Maintenance and Cleaning ............................................................................................................534.7 Paddle Shift ....................................................................................................................................534.8 FAST Compression Mode ...............................................................................................................54

5.0 Magnification Stand ..............................................................................................................................555.1 How to Install and Remove the Magnification Stand ......................................................................55

6.0 Crosshair Devices .................................................................................................................................566.1 How to Install and Remove the Localization Crosshair Device .......................................................566.2 How to Use the Localization Crosshair Device ..............................................................................566.3 How to Install and Remove the Magnification Crosshair Device ....................................................576.4 How to Align the Crosshair Device ................................................................................................57

Chapter 6—Clinical Procedures 59

1.0 Standard Workflow ...............................................................................................................................592.0 Example Screening Procedure ..............................................................................................................60

2.1 How to Position the Patient ............................................................................................................602.2 Set the Exposure Techniques ..........................................................................................................602.3 How to Acquire the Exposure .........................................................................................................612.4 How to Automatically Store the Image ...........................................................................................612.5 How to Accept a Rejected Image ...................................................................................................612.6 How to Accept or Reject a Pended Image ......................................................................................61

Chapter 7—Maintenance and Cleaning 63

1.0 General Information .............................................................................................................................631.1 For General Cleaning .....................................................................................................................631.2 To prevent Possible Injury or Equipment Damage ..........................................................................64

2.0 Acquisition Workstation .......................................................................................................................652.1 How to Clean the Preview Display .................................................................................................652.2 How to Clean the Touchscreen Display .........................................................................................65

2.3 How to Clean the Keyboard ...........................................................................................................652.4 How to Clean the Fingerprint Reader .............................................................................................65

Chapter 8—System Administration Interface 67

1.0 How to Use the Admin Screen .............................................................................................................672.0 How to Use the System Tools ...............................................................................................................70

2.1 The Radiologic Technologist Manager ...........................................................................................70


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User ManualList of Figures

List of Figures

Figure 1-1: Selenia Dimensions .................................................................................................................... 1

Figure 1-2: Label Locations........................................................................................................................... 8Figure 2-1: System Power Controls ............................................................................................................... 9Figure 2-2: Acquisition Workstation Controls and Displays ........................................................................ 10Figure 2-3: Tubestand Controls and Indicators............................................................................................ 12Figure 2-4: C-arm Controls ......................................................................................................................... 13Figure 2-5: Compression Device................................................................................................................. 13Figure 2-6: Compression Display................................................................................................................ 13Figure 2-7: Tubehead Display..................................................................................................................... 14Figure 2-8: Dual Function Footswitches...................................................................................................... 14Figure 2-9: The Startup Screen.................................................................................................................... 15Figure 2-10: How to Log In......................................................................................................................... 16Figure 2-11: C-arm Controls (left side shown) ............................................................................................. 17Figure 2-12: Power Buttons ........................................................................................................................ 23

Figure 3-1: An Example Select Function to Perform Screen......................................................................... 25Figure 3-2: An Example Gain Calibration Screen ........................................................................................ 26Figure 3-3: How to Select a Patient............................................................................................................. 27Figure 3-4: How to Add a New Patient ....................................................................................................... 28Figure 3-5: The Filter Tab in the Patient Filter Screen.................................................................................. 29Figure 3-6: An Example Generator Tab in the Procedure Screen ................................................................. 31Figure 3-7: The Add View Screen ............................................................................................................... 33Figure 3-8: The Add Procedure Dialog Box ................................................................................................ 34Figure 3-9: The Edit View Screen................................................................................................................ 34Figure 3-10: The Print Screen ..................................................................................................................... 37Figure 4-1: The Preview Screen .................................................................................................................. 41Figure 4-2: The Tools Tab in the Procedure Screen..................................................................................... 42Figure 4-3: Marked Images in a Procedure.................................................................................................. 42Figure 4-4: Image Review Tools.................................................................................................................. 43Figure 4-5: Image Review Tabs................................................................................................................... 44Figure 4-6: Icons Available on the Notices Tab........................................................................................... 44Figure 4-7: The Exposure Index .................................................................................................................. 44Figure 5-1: C-arm Accessories .................................................................................................................... 47Figure 5-2: How to Install the Conventional Face Shield............................................................................. 48Figure 5-3: How to Align the Retractable Face Shield on the C-arm............................................................ 49Figure 5-4: Installation................................................................................................................................ 50Figure 5-5: Operation................................................................................................................................. 50Figure 5-6: How to Install a Compression Paddle ....................................................................................... 53Figure 5-7: How to Remove the Compression Paddle ................................................................................. 53Figure 5-8: The FAST Compression Mode Slide .......................................................................................... 54

Figure 5-9: Installation of the Magnification Stand ...................................................................................... 55Figure 5-10: How to Attach the Localization Crosshair Device ................................................................... 56Figure 5-11: How to Install and Remove the Magnification Crosshair Device ............................................. 57Figure 6-1: Screening Example, Conventional Procedure ............................................................................ 60Figure 8-1: The Admin Screen .................................................................................................................... 68Figure A-1: Tubestand Dimensions............................................................................................................. 73Figure A-2: Acquisition Workstation Dimensions........................................................................................ 74


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User ManualList of Tables

List of Tables

Table 2-1: C-arm Functional Tests ...............................................................................................................17

Table 3-1: Taskbar Menus ...........................................................................................................................39Table 8-1: Admin Screen Functions .............................................................................................................69Table 8-2: Radiologic Technologist Manager—Service Tools Functions.......................................................71Table A-1: mA Setting as a Function of kV...................................................................................................78Table B-1: System Messages ........................................................................................................................82


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P/N MAN-01964 Revision 001 xiii


User ManualPreface

Intended Use

Preface

1.0 Intended Use

The Hologic Selenia® Dimensions® Digital Breast Tomosynthesis System generates digitalmammographic images that can be used for screening and diagnosis of breast cancer. TheSelenia Dimensions system is intended for use in the same clinical applications as Full FieldDigital Mammography systems for screening mammograms. Specifically, the SeleniaDimensions system can be used to acquire two-dimensional full field digital mammogramsand three-dimensional tomosynthesis mammograms. The screening examination will consistof a two-dimensional image set or a two-dimensional and tomosynthesis image set. TheSelenia 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 largemammography film.

• Tomosynthesis scan with a digital image receptor equivalent in size to largemammography 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 andcalibrations, 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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User ManualPrefaceTraining Requirements

5.0 Training Requirements

Hologic™ does not accept the responsibility for injury or damage from wrong systemoperation.

Make sure that you receive training on the Selenia Dimensions before use on patients.Hologic training programs address MQSA training regulations for any Technologist orPhysician.

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 QualityAssurance and Quality Control program. The facility must create the program to meet therequirements of the Mammography Quality Standards Act or to be accredited by ACR oranother accreditation body.

The facilities outside the United States can use the Quality Control Manual as a guide tocreate 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 examinepossible security problems. When necessary, Hologic provides the updates to the product.

For Cybersecurity Best Practices documents for Hologic products, refer to the HologicInternet 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 preventpossible serious injury or death.

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

Caution: Cautions point out procedures that you must follow accurately toprevent the damage to equipment, loss of data, or damage to files in

software applications.

Note… Notes indicate additional information.


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User ManualPreface

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 receptorthat is exposed.

Combo Procedure An image acquisition procedure for which the system takesa conventional mammography image and a tomosynthesisscan during a single patient compression (Tomosynthesisoption).

Conventional Mammography Single projection x-ray images of views for screening anddiagnostic 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 reducesscatter 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, TechnologistWorkstations, and Acquisition Workstations.

PACS Picture Archiving and Communications System. Acomputer and network system for the transfer and archiveof digital medical images.

Pend A mark on the image to indicate the Technologist is notpositive about the image quality. Pended images must beAccepted or Rejected before the procedure is closed.

Projection Images The group of x-ray images for tomosynthesis taken atdifferent 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 ofprojections taken at different angles. The tomosynthesisimages can be reconstructed to show planes or sliceswithin the object (Tomosynthesis option).

UPS Uninterruptible Power Supply


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User ManualPrefaceInternational Symbols

10.0 International Symbols

This section describes the International Symbols on the Selenia Dimensions.

11.0 Document Standards

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

Potential Equalizationterminal

Connection for a conductor different from the ProtectiveEarth for a direct connection between two or more piecesof electrical equipment.

Protective Earthterminal

For the connection of the line cord ground or groundcable 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.

Off Only a part of the equipment is disconnected from the

main power source.

OnOnly a part of the equipment is connected to the mainpower source.

WEEESymbol that indicates separate removal for electrical andelectronic equipment.

Dangerous Voltage Identifies an area of possible lethal voltage.

Manufacturer

Date of Manufacture


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User ManualChapter 1—General InformationSafety Information

WARNING! Per North American electrical safety requirements, youmust use a Hospital Grade receptacle to provide a correctGround.

WARNING! Do not use the electrical equipment near flammableanesthetics.

Warning: This device contains dangerous material. Return to Hologic allmaterial removed from service.

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

Warning: The user must arrange for preventive maintenance by anauthorized service representative.

Warning: If a paddle touches possible infectious materials, call yourInfection Control Representative for decontaminationinstructions.

Caution : The system is a medical device and not a normal computer. Do notmake changes to the hardware or software that are not authorized.Install this device behind a firewall for network security. Thecomputer virus protection or network security for this medical deviceis not provided (for example, a computer firewall). The networksecurity and anti-virus provisions are the responsibility of the user.

Caution : Only use the approved accessories with this equipment. The failure tofollow this caution can cause errors and possible data loss.

Note… Hologic does not provide the Gantry power cable for some countries. Ifthe power cable is not provided, the installed cable must meet thefollowing requirements and all local codes that apply: 3 conductor, 8

AWG (10 mm 2) copper not more than 25 feet (7.62 meters) in length.


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User ManualChapter 1—General Information

Safety Information

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 onlyapproved accessories or options to the system. Only theauthorized personnel can make changes to theconnections.

WARNING! Keep a 1.5 meter safe distance between the patient and

any non-patient devices.Non-patient system components (like the WorkflowManager, the diagnostic review workstation, or the hardcopy printer) must not be installed in the Patient Area.

Warning: Never leave the patient during the procedure if in contact withthe mammography system.

Warning: Keep the hands of the patient away from all buttons andswitches 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 theAEC exposure adjustment setting. You increase the image noiseor decrease image quality if you decrease the AEC exposure

adjustment setting.

Warning: Put both footswitches away from the patient and C-arm area toprevent any accidental footswitch use. When the patient has awheelchair, put the footswitches away from the area.

Warning: Control the access to the equipment according to localregulations for radiation protection.

2.3 Radiation Safety

WARNING! This x-ray system can be dangerous to the patient and theuser. Always follow the safety precautions for x-rayexposures.

Warning: For exposures except magnification case studies, always use theFace Shield.

Warning: The Face Shield does not protect from radiation.

WARNING! The disk drives installed in this system are a Class I LaserProduct. Prevent direct exposure to the beam. Hiddenlaser radiation exists if the case to a disk drive is open.

Warning: The bar code reader installed in this system is a Class II LaserProduct. Prevent direct exposure to the beam. Hidden laserradiation exists if the cover is opened.

Warning: You must keep your complete body behind the radiation shieldfor the time of the exposure for maximum protection from x-rayexposure.


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Safety Information

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 inemergency. The circuit breaker can turn off the Uninterruptible PowerSupply (UPS) and risk data loss.

Caution : Do not put any magnetic media near or on devices that create anymagnetic 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 ImageReceptor, follow the recommended procedure to turn off theequipment.

Caution : Do not make any brightness or contrast adjustments to the displayunless the SMPTE test pattern is on the screen.

Caution : Use the least possible amount of cleaning fluids. The fluids must notflow or run.

Caution : Do not spray disinfectant on the system, because the moisture canenter 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 theEmergency 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 theFilter is not aligned.


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Compliance

3.0 Compliance

This section describes the mammography system compliance requirements and theresponsibilities of the manufacturer.

3.1 Compliance Requirements

The manufacturer has the responsibility for the safety, reliability, and performance of thisequipment 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 performedonly by authorized persons.

• The network and communication equipment must be installed to meet IEC Standards.The complete system (network and communications equipment and Selenia DimensionsMammography 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—GeneralRequirements 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—GeneralRequirements for Safety

• IEC 60601-1-1:2000-12 Medical Electrical Equipment—Collateral Standard: SafetyRequirements 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: Requirementsfor 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 theSafety of High-Voltage Generators of Diagnostic X-ray Equipment

• IEC 60601-2-28:1993-03 Medical Electrical Equipment—Particular Requirements for theSafety 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—GeneralRequirements for Safety


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User ManualChapter 1—General InformationLabel Locations

4.0 Label Locations

Figure 1-2: Label Locations


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User ManualChapter 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 2-11. 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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User ManualChapter 2—System Controls and IndicatorsAcquisition Workstation Controls and Display

2.0 Acquisition Workstation Controls and Display

Figure 2-2: Acquisition Workstation Controls and Displays

Legend for Figure 2-21. Trackball

2. Scroll Wheel3. 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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Acquisition Workstation Controls and Display

2.1 Keyboard

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

2.2 Bar Code ReaderUse 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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User ManualChapter 2—System Controls and IndicatorsTubestand 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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Tubestand Controls and Indicators

3.1 C-arm Controls

3.2 Compression Device Controls and Displays

The C-arm Controls provide theCollimator and C-arm functions.See Section 5.0, page 17.

Figure 2-4: C-arm Controls

Legend for Figure 2-51. Manual Compression Handwheels

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 compressiondevice shows:

• AEC Sensor Position

• Compression Force (displays 0.0when force is less than 4 pounds)

• Compression Thickness

• Angle of C-arm after rotation (for10 seconds)

Figure 2-6: Compression Display

A E C P O S I T I O N


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User ManualChapter 2—System Controls and IndicatorsTubestand Controls and Indicators

3.3 Tubehead Display

3.4 Dual Function Footswitches

Warning: Put both footswitches away from the patient and C-arm area toprevent any accidental footswitch use. When the patient has awheelchair, put the footswitches away from the area.

The Tubehead Display shows:

• SID

• Filter Type

• Collimator Setting

• Paddle Position

Figure 2-7: Tubehead Display

SID: 70 cm

Rh

Coll: 24x29

C

To use the footswitches:

1. Press the footswitch to actuate.

2. Release the switch to stop themovement.

Legend for Figure 2-81. C-arm Down

2. C-arm Up

3. Compression Down

4. Compression Up

Figure 2-8: Dual Function Footswitches

C O M P R E S S I O N C -A R M


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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 shutdown.

2. Press the computer power button at the rear of the Acquisition Workstation (seeFigure 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 forimage acquisition. The wait time depends on the detector powerconfiguration. A timer in the Taskbar displays the wait time before thesystem is ready. Do not acquire clinical or QC images unless the SystemStatus Icon indicates the system is Ready.

Note… The Startup screen includes a Shutdown button that turns off the wholesystem, and a Reboot button that restarts the system.


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Perform the Functional Tests

5.0 Perform the Functional Tests

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

Legend for Figure 2-111. 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-armRotation

9. Compression Up

10. Compression Down

A C-arm control panel is onboth the left and right sidesof the Gantry.

Figure 2-11: C-arm Controls (left side shown)

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, thecompression brake remains engaged until the CompressionRelease 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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User ManualChapter 2—System Controls and IndicatorsPerform the Functional Tests

Compression Up Press a Compression Up button:• The Compression Device moves toward the top.

• The Compression Up button does not release theCompression 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 thebutton is released.

• The C-arm movement automatically stops when theC-arm reaches the upper travel limit.

• The C-arm movement is disabled when a compressionforce of 45 N (10 pounds) or greater is applied.




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Perform the Functional Tests

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 theC-arm reaches the lower travel limit.

• The C-arm movement is disabled when a compressionforce of 45 N (10 pounds) or greater is applied.




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User ManualChapter 2—System Controls and IndicatorsPerform the Functional Tests

Collimator Override The Collimator Override button changes the collimationthrough the different x-ray fields.Press the light field lamp button to show the x-ray field, thenpress 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 forapproximately 30 seconds.The light field lamp automatically illuminates with the startof the Compression Down movement.

Motor Enable Reserved for future use.

C-arm Zero Reserved for future use.

Shifting PaddleSystem

The 18 x 24-cm Screening Paddle moves approximately 2.5cm into the left, center, or right position. While thecompression is applied, you can not move the paddle. Thecollimator is programmed to follow the position of thepaddle.To test this function:

1. Install the 18 x 24-cm paddle in the CompressionDevice.

2. Select a view. Use the Paddle Shift buttons on theprocedure screen to override the position.

Verify that the paddle automatically moves to the newposition.

3. Turn on the light field lamp. Confirm that the collimatorposition matches the paddle position.

4. Repeat this procedure for the other paddle positions.A FAST Compression Mode Slide on the CompressionDevice lets you set the system for FAST Mode or for NormalMode.To select the mode, move the Slide to the “F” position fromeither side of the Compression Device. The default shiftpositions are configurable through Service Tools.



A E C

P O S IT I O N


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How to Turn Off the System

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 theAcquisition Workstation circuit breaker.

2. Turn off the Acquisition Workstation circuit breaker (Number 1).

3. Disconnect the Acquisition Workstation power cable.

Emergency Off Switches There are three Emergency Off switches, one on each side ofthe Gantry and one on the Acquisition Workstation.Press any of the Emergency Off switches to turn Off theGantry.Turn the Emergency Off switch by one-quarter turn to resetthe switch.




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User ManualChapter 2—System Controls and IndicatorsHow to Remove All Power from the Acquisition Workstation


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User ManualChapter 3—The User InterfaceSelect 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 performany 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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User ManualChapter 3—The User InterfaceHow to Perform the Quality Control Tasks

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. Selectthe Admin button (on the Select Patient screen). Select the QualityControl button on the Admin screen to display the list.

Note… If a calibration is scheduled on the current date, you can not perform aprocedure until the calibration is completed.


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User ManualChapter 3—The User Interface

How to Select a Patient

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 rightpermissions 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 Dis

cont

inued 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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User ManualChapter 3—The User InterfaceHow to Select a Patient

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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How to Select a Patient

3.5 How to Use a Patient Filter

When you select the Filter button in the Select Patient screen, the Patient Filter screen for theselected 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 pageof the Select a Patient screen.

• The Filter tab accesses the parameters that select the patients who appear on the selectedtab 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 tabson 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 Ref resh Worklist button to update the screen.


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User ManualChapter 3—The User InterfaceHow to Select a Patient

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. Scanthe configured field bar code. The scheduled procedure displays and the patient isadded to the local database. By default, the user can scan on the Patient ID, AccessionNumber, or Requested Procedure ID.

• Keyboard—Use one or more fields to query the Modality Worklist Provider. All fields toquery are configurable. The default fields are as follows: the Patient name, the Patient ID,Accession Number, Requested Procedure ID, Scheduled Procedure Date. The scheduledprocedure 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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The Procedure Screen

4.0 The Procedure Screen

Select the Generator tab (at the top of the screen on the left side) to adjust the exposuretechniques 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)

4.1.2 Select the Exposure Mode

Use the Automatic Exposure Control modes (AEC) to let the system control theexposure techniques.

• Standard For routine Tomosynthesis screening procedures

• Enhanced For diagnostic views. This mode increases the patient dose.

• Manual The user selects the kV, mAs, Focal Spot, and Filter.

• AEC: Auto-Time The user selects the kV, Focal Spot, and Filter. The systemselects 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.


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User ManualChapter 3—The User InterfaceThe Procedure Screen

4.1.3 How to Use the AEC Sensor

The AEC Sensor has seven manual positions and an automatic position. The manualpositions 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 Sensorarea of the screen to change the sensor position. You can select Auto AEC to allowthe 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 theProcedure screen. This button applies special implant processingto the implant and the implant displaced views, and changes the“Implant Present” DICOM tag in the image header. When thisbutton is selected, a checkmark appears on the button.

Select the Implant Present button for both implant and implant displaced views before youacquire the image.

Note… The Implant Present button is automatically selected if there is an IDview 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, aSystem Message appears, a tone sounds, and the x-ray indicator on the control panellights to indicate x-ray emission.

3. The image displays when the x-ray is complete. You must select how to complete theacquisition.

• You can Accept the image. The locked image transmits to output devices with allattributes and marks.

• You can Reject the image. The Preview closes. You can repeat the rejected view, orselect 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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The Procedure Screen

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.

Note… ID indicates Implant Displaced.

2. Select the tab, then select the view. You can select a maximum of 3 View Modifiers fromthe 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.

Figure 3-7: The Add View Screen

View Modifiers

ID = Implant DisplacedRL = Rolled LateralRM = Rolled MedialRI = Rolled InferiorRS = Rolled SuperiorNP = Nipple in ProfileAC = Anterior CompressionIMF = Infra-Mammary Fold

AX = Axillary Tissue


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User ManualChapter 3—The User InterfaceThe Procedure Screen

4.5 How to Add a Procedure

1. To add another procedure, select the Add Procedure button on the Procedure screen todisplay 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 procedurewhich 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. SeeFigure 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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How to Access Image Review Features

4.7 How to Close a Procedure

Select the Close Patient button. If you acquired images, a Close Procedure dialog boxdisplays. Select one of the following options:

If there are images marked as Pend, you must respond to the confirmation prompt to closethe procedure In-Progress.

If MPPS is activated, messages are sent to the output devices when you select Complete andDiscontinue. You can also click and hold the tab above the thumbnail images to resend amessage about the procedure status during the procedure. A Procedure Action dialog boxappears with buttons to resend a status or to return to the procedure.

5.0 How to Access Image Review FeaturesSelect the Tools tab on the Procedure screen to access the image review features. SeeChapter 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 afterthe image is Accepted.

6.1 How to Select an Output Set

Select an output device set like PACS, Diagnostic Workstations, CAD devices and printersfrom 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.

• Close Procedure Complete Closes the procedure and puts the procedure in theComplete tab.

• Close Procedure In Progress Closes the procedure and puts the procedure in the InProgress tab.

• Close ProcedureDiscontinued

Closes the procedure and puts the procedure in theDiscontinued tab. A dialog box appears and you mustselect the reason the procedure was discontinued from alist or add a new reason.

• Return To procedure Returns to procedure.

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User ManualChapter 3—The User InterfaceHow to Use the On-Demand Outputs

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 OutputsYou 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 anyof 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 St

art

button to copy all selected images from the opened case study to theselected device.

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

status.


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How to Use the On-Demand Outputs

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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About the Taskbar

9.0 About the TaskbarThe taskbar at the bottom of the screen displays additional icons, which you can select toaccess information or perform system tasks.

Table 3-1: Taskbar Menus

Description Menu

1 Information IconSelect 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 theManage Alarms option to display and close any open alarms.

2 Current User NameSelect 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 editOperator information, change your password, or use theFingerprint Capture feature.Print prints the displayed patient list to a connected printer.

3 Output Device IconsSelect an output icon (query retrieve, workstation/archive, printer,or CD-ROM) to display a menu. Each menu selection takes you tothe screen for that selection.Manage Queues displays the status of jobs in the queue and jobdetails for the selected output, and allows you to filter the queuedisplay.

4 Notice IconSelect 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 optionsfor the message like date or title.

5 System Status IconsSelect the Tubehead icon to display a menu. When a greencheckmark appears next to the tubehead icon, the detector andgenerator are ready for use.

Clear

All Faults

deletes all error messages.Zero Tubehead puts the tubehead at zero degrees of rotation for thenext exposure.System Diagnostics accesses Subsystem settings.System Defaults opens the Gantry Defaults screen to set theCompression and Generator default values.About displays information about the Acquisition Workstation.


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User ManualChapter 3—The User InterfaceAbout the Taskbar


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User ManualChapter 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 theimage and add the annotations, then Accept, Reject, or Pend the image. A thumbnail imageappears 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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User ManualChapter 4—The ImagesHow to Review the Images

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 thumbnailimage is marked if the image is not accepted.

Figure 4-3: Marked Images in a Procedure


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How to Review the Images

2.1 The Image Review Tools Tab

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

Figure 4-4: Image Review Tools

Legend for Figure 4-41. 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 ACRPhantom image.

6. The AEC button displays the AEC Sensor areas used for the exposure calculation. The sensor areasdisplay 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 toprint later (Tomosynthesis option).


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User ManualChapter 4—The ImagesHow to Review the Images

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 Arrowbutton (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 indicatesthe red or yellow area, review the selected image for noise and make a decisionabout a retake.


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Send the Images to the Output Devices

2.2.3 Display Modes (Tomosynthesis option)

Use the CONV, PRJ, and REC buttons to select the type of view to display in thePreview 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 withoutthe Implant Present button activated.

2.3.1 If You Did Not Accept the Image:

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

instructions.

Select the Implant Present button on theProcedure screen to indicate an implant exists.

A checkmark appears on the button and theimage reprocesses.


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User ManualChapter 4—The ImagesSend the Images to the Output Devices


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User ManualChapter 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 specifiedaccessories. This chapter describes how to use all possible system accessories. Youraccessories 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 installedin slots on the C-arm. The slots have labels with icons to indicate the accessory that attachesin 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 alignswith the line on the C-arm.

The next sections contain installation instructions for each accessory.

Figure 5-1: C-arm Accessories

Legend for Figure

mammography unit selenia dimensions (3d) - user manual

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