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PCB00116
Users Manual
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Hologic PCB00116 Users Manual

DRAFT
DRAFT
DRAFT
DRAFT
User Manual
DRAFT
Table of Contents
Table of Contents
List of Figures xi
List of Tables xiii
1.0 Intended Use Statements ...................................................................................................................... xv
1.1 Intended Use .................................................................................................................................. xv
1.2 Intended Use (Tomosynthesis Option) ............................................................................................ xv
2.0 System Capabilities ............................................................................................................................... xv
3.0 Users .................................................................................................................................................... xv
4.0 Skills Needed for System Use .............................................................................................................. xvi
5.0 Training Requirements ......................................................................................................................... xvi
6.0 Quality Control Requirements ............................................................................................................. xvi
7.0 Product Complaints ............................................................................................................................. xvi
8.0 Hologic Cybersecurity Statement ......................................................................................................... xvi
9.0 Warnings, Cautions, and Notes .......................................................................................................... xvii
10.0 Terms and Definitions ..................................................................................................................... xviii
11.0 International Symbols ........................................................................................................................ xix
12.0 Document Standards ......................................................................................................................... xix
Chapter 1—General Information 1
1.0 System Description .................................................................................................................................1
1.1 Tubestand ........................................................................................................................................ 1
1.2 Acquisition Workstation ................................................................................................................... 2
2.0 Safety Information .................................................................................................................................. 3
2.1 General Safety ..................................................................................................................................3
2.2 Patient Safety ...................................................................................................................................4
2.3 Radiation Safety ...............................................................................................................................5
2.4 Data Loss .........................................................................................................................................6
2.5 Equipment Damage .......................................................................................................................... 6
2.6 Emergency Off Switches ................................................................................................................... 7
2.7 Interlocks ......................................................................................................................................... 7
3.0 Compliance ............................................................................................................................................ 8
3.1 Compliance Requirements ............................................................................................................... 8
3.2 Compliance Statements .................................................................................................................... 9
4.0 Label Locations ....................................................................................................................................10
Chapter 2—System Controls and Indicators 11
1.0 System Power Controls ......................................................................................................................... 11
2.0 Acquisition Workstation Controls and Indicators .................................................................................. 12
2.1 Premium Acquisition Workstation Controls and Displays ............................................................... 12
2.2 Standard Acquisition Workstation Controls and Displays ...............................................................13
2.3 Keyboard .......................................................................................................................................13
2.4 Bar Code Scanner ..........................................................................................................................13
2.5 Premium Acquisition Workstation Touchscreen Display ................................................................13
2.6 Standard Acquisition Workstation Control Display .........................................................................13
2.7 Preview Display ............................................................................................................................. 13
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3.0 Tubestand Controls and Indicators ....................................................................................................... 14
3.1 C-Arm Controls ............................................................................................................................. 15
3.2 Compression Device Controls and Displays .................................................................................. 15
3.3 Tubehead Display ......................................................................................................................... 16
3.4 Dual Function Footswitches .......................................................................................................... 16
4.0 How to Turn On the Selenia Dimensions ............................................................................................. 17
4.1 Preparation .................................................................................................................................... 17
4.2 Startup ........................................................................................................................................... 17
4.3 Log In ............................................................................................................................................ 18
5.0 How to Change the Language .............................................................................................................. 18
6.0 Perform the Functional Tests ................................................................................................................ 19
7.0 How to Turn Off the System ................................................................................................................. 25
8.0 How to Remove All Power from the Acquisition Workstation .............................................................. 25
Chapter 3—The User Interface 27
1.0 Select the Function to Perform ............................................................................................................. 27
2.0 How to Perform the Quality Control Tasks ........................................................................................... 28
3.0 The Select Patient Screen ..................................................................................................................... 29
3.1 How to Open a Procedure ............................................................................................................. 29
3.2 How to Add a New Patient ............................................................................................................ 30
3.3 How to Edit the Patient Information ............................................................................................... 30
3.4 How to Delete a Patient ................................................................................................................ 30
3.5 The Patient Filter Screen ................................................................................................................ 31
3.6 How to Refresh the Worklist .......................................................................................................... 32
3.7 How to Query the Worklist ........................................................................................................... 33
3.8 About the Admin Button ................................................................................................................ 33
3.9 How to Log Out ............................................................................................................................ 33
4.0 The Procedure Screen .......................................................................................................................... 34
4.1 How to Set the Exposure Parameters .............................................................................................. 34
4.2 How to Use the Implant Present Button ......................................................................................... 35
4.3 How to Acquire an Image .............................................................................................................. 35
4.4 How to Add or Remove a View ..................................................................................................... 36
4.5 How to Add a Procedure ............................................................................................................... 37
4.6 How to Edit a View ....................................................................................................................... 37
4.7 How to Close a Procedure ............................................................................................................. 38
5.0 How to Access Image Review Features ................................................................................................ 38
6.0 How to Use the Output Sets ................................................................................................................. 39
6.1 How to Select an Output Set ......................................................................................................... 39
6.2 How to Add or Edit an Output Set ................................................................................................. 39
7.0 How to Use the On-Demand Outputs .................................................................................................. 39
7.1 How to Archive ............................................................................................................................. 39
7.2 How to Print .................................................................................................................................. 40
7.3 How to Export ............................................................................................................................... 41
8.0 How to Use the Paddle Shift Feature .................................................................................................... 41
9.0 About the Taskbar ................................................................................................................................ 42
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Chapter 4—The Images 43
1.0 Introduction .......................................................................................................................................... 43
1.1 Conventional Sequence of Events ................................................................................................... 43
1.2 Tomosynthesis Sequence of Events (Tomosynthesis option) ............................................................43
2.0 How to Review the Images ................................................................................................................... 44
2.1 The Image Review Tools Tab .........................................................................................................45
2.2 Other Image Review Tools .............................................................................................................46
2.3 How to Correct and Reprocess Implant Images ..............................................................................47
3.0 Send the Images to the Output Devices ................................................................................................ 47
Chapter 5—How to Use the Accessories 49
1.0 Introduction .......................................................................................................................................... 49
2.0 How to Install Accessories on the C-Arm ..............................................................................................49
3.0 The Patient Face Shields .......................................................................................................................50
3.1 How to Install or Remove the Retractable Face Shield ....................................................................50
3.2 How to Use the Retractable Face Shield ......................................................................................... 51
3.3 How to Install or Remove the Conventional Face Shield ................................................................52
4.0 Compression Paddles ........................................................................................................................... 53
4.1 Routine Screening Paddles .............................................................................................................53
4.2 Contact and Spot Compression Paddles ......................................................................................... 53
4.3 Localization Paddles ......................................................................................................................54
4.4 Magnification Paddles .................................................................................................................... 54
4.5 How to Install or Remove a Compression Paddle ........................................................................... 55
4.6 Maintenance and Cleaning ............................................................................................................55
4.7 Paddle Shift .................................................................................................................................... 55
4.8 FAST Compression Mode ...............................................................................................................56
5.0 Magnification Stand .............................................................................................................................. 57
5.1 How to Install and Remove the Magnification Stand ......................................................................57
6.0 Crosshair Devices ................................................................................................................................. 58
6.1 How to Install and Remove the Localization Crosshair Device .......................................................58
6.2 How to Use the Localization Crosshair Device ..............................................................................58
6.3 How to Install and Remove the Magnification Crosshair Device .................................................... 59
6.4 How to Align the Crosshair Device ................................................................................................ 59
Chapter 6—Clinical Procedures 61
1.0 Standard Workflow ............................................................................................................................... 61
1.1 Preparation ....................................................................................................................................61
1.2 At the Gantry ................................................................................................................................. 61
1.3 At the Acquisition Workstation ....................................................................................................... 61
2.0 Screening Procedure Example .............................................................................................................. 62
2.1 How to Position the Patient ............................................................................................................ 62
2.2 Set the Exposure Techniques .......................................................................................................... 62
2.3 How to Acquire the Exposure ......................................................................................................... 63
2.4 How to Automatically Store the Image ........................................................................................... 63
2.5 How to Accept a Rejected Image ...................................................................................................63
2.6 How to Accept or Reject a Pended Image ...................................................................................... 63
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Chapter 7—Maintenance and Cleaning 65
1.0 General Information ............................................................................................................................. 65
1.1 For General Cleaning .................................................................................................................... 65
1.2 To prevent Possible Injury or Equipment Damage .......................................................................... 66
2.0 Acquisition Workstation ....................................................................................................................... 67
2.1 How to Clean the Preview Display ................................................................................................ 67
2.2 How to Clean the Touchscreen Display ......................................................................................... 67
2.3 How to Clean the Keyboard .......................................................................................................... 67
2.4 How to Clean the Fingerprint Scanner ........................................................................................... 67
3.0 Preventive Maintenance Schedule ....................................................................................................... 68
Chapter 8—System Administration Interface 69
1.0 How to Use the Admin Screen ............................................................................................................. 69
2.0 How to Use the System Tools .............................................................................................................. 72
2.1 The Radiologic Technologist Manager ........................................................................................... 72
Appendix A—Specifications 75
1.0 Product Measurements ......................................................................................................................... 75
1.1 Tubestand (Gantry with C-Arm) ..................................................................................................... 75
1.2 Premium Acquisition Workstation ................................................................................................. 76
1.3 Standard Acquisition Workstation .................................................................................................. 77
2.0 Operation and Storage Environment .................................................................................................... 78
2.1 General Conditions for Operation ................................................................................................. 78
2.2 Storage Environment ...................................................................................................................... 78
3.0 Acquisition Workstation Technical Information ................................................................................... 78
4.0 Electrical Input ..................................................................................................................................... 79
4.1 Tubestand ...................................................................................................................................... 79
4.2 Acquisition Workstation ................................................................................................................ 79
5.0 Tubestand Technical Information ......................................................................................................... 79
5.1 C-Arm ........................................................................................................................................... 79
5.2 Compression ................................................................................................................................. 80
5.3 X-Ray Tube .................................................................................................................................... 80
5.4 X-Ray Beam Filtration and Output ................................................................................................. 81
5.5 X-Ray Collimation ......................................................................................................................... 82
5.6 Light Field Indication ..................................................................................................................... 82
5.7 X-Ray Generator ............................................................................................................................ 82
6.0 Imaging System Technical Information ................................................................................................. 82
6.1 Image Receptor ............................................................................................................................. 82
Appendix B—The System Messages and Alert Messages 83
1.0 Error Recovery and Troubleshooting .................................................................................................... 83
2.0 Types of Messages and Alert messages ................................................................................................. 83
2.1 Fault Levels ................................................................................................................................... 83
2.2 System Messages ........................................................................................................................... 84
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Appendix C—Dimensions Mobile 85
1.0 General Information ............................................................................................................................. 85
2.0 Conditions for Safety and Other Precautions ......................................................................................... 85
3.0 Mobile Specifications ........................................................................................................................... 86
3.1 Shock and Vibration Limits ............................................................................................................86
3.2 Coach Environment ........................................................................................................................ 86
4.0 Electrical Input ..................................................................................................................................... 86
4.1 Gantry ............................................................................................................................................86
4.2 Acquisition Workstation ................................................................................................................. 86
5.0 Prepare the System for Travel ...............................................................................................................87
6.0 Prepare the System for Use ................................................................................................................... 87
7.0 Test the System after Travel ..................................................................................................................88
7.1 Selenia Dimensions Controls and Functional Tests ......................................................................... 88
8.0 Quality Control Tests ............................................................................................................................88
List of Addenda 89
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List of Figures
List of Figures
Figure 1-1: Selenia Dimensions .................................................................................................................... 1
Figure 1-2: Acquisition Workstations ............................................................................................................ 2
Figure 1-3: Label Locations......................................................................................................................... 10
Figure 2-1: System Power Controls ............................................................................................................. 11
Figure 2-2: Premium Acquisition Workstation Controls and Displays ......................................................... 12
Figure 2-3: Standard Acquisition Workstation Controls and Displays.......................................................... 13
Figure 2-4: Tubestand Controls and Indicators............................................................................................ 14
Figure 2-5: C-Arm Controls......................................................................................................................... 15
Figure 2-6: Compression Device................................................................................................................. 15
Figure 2-7: Compression Display................................................................................................................ 15
Figure 2-8: Tubehead Display..................................................................................................................... 16
Figure 2-9: Dual Function Footswitches...................................................................................................... 16
Figure 2-10: Premium Acquisition Workstation Power Buttons ................................................................... 17
Figure 2-11: Standard Acquisition Workstation Power Buttons ................................................................... 17
Figure 2-12: The Startup Screen.................................................................................................................. 17
Figure 2-13: How to Log In......................................................................................................................... 18
Figure 2-14: C-Arm Controls (left side shown) ............................................................................................ 19
Figure 3-1: An Example Select Function to Perform Screen ......................................................................... 27
Figure 3-2: An Example Quality Control Screen.......................................................................................... 28
Figure 3-3: The Select Patient Screen .......................................................................................................... 29
Figure 3-4: How to Add a New Patient ....................................................................................................... 30
Figure 3-5: The Filter Tab in the Patient Filter Screen .................................................................................. 31
Figure 3-6: /The Generator Tab in an Example Procedure Screen ............................................................... 34
Figure 3-7: The Add View Screen ............................................................................................................... 36
Figure 3-8: The Add Procedure Dialog Box ................................................................................................ 37
Figure 3-9: The Edit View Screen................................................................................................................ 37
Figure 3-10: The Print Screen ..................................................................................................................... 40
Figure 3-11: Paddle Shift Buttons................................................................................................................ 41
Figure 4-1: The Preview Screen .................................................................................................................. 43
Figure 4-2: The Tools Tab (Tomosynthesis option shown)........................................................................... 44
Figure 4-3: Marked Images in a Procedure (Tomosynthesis option shown).................................................. 44
Figure 4-4: Image Review Tools.................................................................................................................. 45
Figure 4-5: Icons Available on the Notices Tab........................................................................................... 46
Figure 4-6: Exposure Index ......................................................................................................................... 46
Figure 4-7: Exposure Index ......................................................................................................................... 47
Figure 5-1: C-Arm Accessories.................................................................................................................... 49
Figure 5-2: How to Align the Retractable Face Shield on the C-Arm ........................................................... 50
Figure 5-3: Installation ................................................................................................................................ 51
Figure 5-4: Operation ................................................................................................................................. 51
Figure 5-5: How to Install the Conventional Face Shield............................................................................. 52
Figure 5-6: How to Install a Compression Paddle ....................................................................................... 55
Figure 5-7: How to Remove the Compression Paddle ................................................................................. 55
Figure 5-8: The FAST Compression Mode Slide .......................................................................................... 56
Figure 5-9: Installation of the Magnification Stand ...................................................................................... 57
Figure 5-10: How to Attach the Localization Crosshair Device ................................................................... 58
Figure 5-11: How to Install and Remove the Magnification Crosshair Device ............................................. 59
Figure 6-1: Screening Example, Conventional Procedure ............................................................................ 62
Figure 8-1: The Admin Screen .................................................................................................................... 70
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List of Figures
Figure A-1: Tubestand Dimensions ............................................................................................................ 75
Figure A-2: Premium Acquisition Workstation Dimensions ........................................................................ 76
Figure A-3: Standard Acquisition Workstation Dimensions......................................................................... 77
Figure C-1: Keyboard Tray Lock Knob........................................................................................................ 87
Figure C-2: How to Unlock the Keyboard .................................................................................................. 87
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