Artwork and Signature File for:

9-500-0290, “MNL, MULTICARE PLATINUM OPS”

Artwork consists of:

 One hundred and eighty -eight (188) 8 ½ inch x 11 inch pages.

REV AUTHORED BY DATE

M PELLET 9/15/2004
REV DRAFTED BY DATE
B. MOSES 9/16/2004 DANBURY, CT 06810
PROPRIETARY INFORMATION: TITLE DOCUMENT NUMBER REV
The content of this document is the
exclusive property of Lorad and may MNL, MULTICARE AW-00231 003
not, without prior written permission of
Lorad, be reproduced, copied or used for
PLATINUM OPS
any purpose whatsoever. ARTWORK SIZE A SHEET 1 OF 1
ENG-0034-T33, Rev. 001
 Operator’s Manual

Part Number 9-500-

0290

Revision 003
 Operator’s Manual

Table of Contents

List of Figures ix

List of Tables xiii

Preface xi
1.0 Intended Use....................................................................................................... xi
2.0 Quality Control.................................................................................................... xi
3.0 User Training....................................................................................................... xi
4.0 Using the Operator’s Manual....................................................................................xi
5.0 Terms.............................................................................................................. xii
6.0 Warnings, Cautions, and Notes.................................................................................xii
6.1 Definitions.................................................................................................... xii
Chapter 1—General Information 1
1.0 Introduction........................................................................................................ 1
2.0 Unit Description.................................................................................................... 2
2.1 The MultiCare Platinum Table..............................................................................3
2.2 The Generator Package......................................................................................3
2.3 The DSM Console........................................................................................ 3
2.4 The Handheld Console........................................................................................ 3
3.0 Safety................................................................................................................ 4
3.1 Radiation Safety............................................................................................... 4
3.2 Technologist and Patient....................................................................................4
3.3 Emergency Stop Switches....................................................................................5
4.0 Compliance................................................................................................... 6
4.1 Compliance Requirements...................................................................................6
4.2 Compliance Statements......................................................................................6
4.3 Certifiable Components......................................................................................9
Chapter 2—Using the MultiCare Platinum System 11
1.0 Introduction....................................................................................................... 11
2.0 The Table Platform..............................................................................................11
3.0 MultiCare Platinum Table Control Panel......................................................................12
3.1 Using the MultiCare Platinum Table Controls...........................................................13
3.2 Table Levelers...............................................................................................14
4.0 The Needle Guidance Stage Operation........................................................................15
4.1 The Needle Guidance Stage Assembly....................................................................15
5.0 The Stage Display Panels........................................................................................16
6.0 The Motor Control Keypad......................................................................................17
7.0 The Stage Keypad................................................................................................ 18
8.0 The Manual Axis Controls (X, Y, and Z axis)..................................................................20
9.0 The DSM System Controls and Display.........................................................................20
9.1 DSM Cart Assembly..........................................................................................21
9.2 DSM Workstation....................................................................................... 22
10.0 The Digital Image Receptor...................................................................................23
11.0 The Handheld Console.......................................................................................... 23
12.0 The DSM Monitor.......................................................................................... 23

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13.0 The DSM Computer.............................................................................................. 24

14.0 The DSM Trackball..............................................................................................25
15.0 The DSM Keyboard........................................................................................ 26
Chapter 3—Using the Handheld Console 27
1.0 Introduction....................................................................................................... 27
2.0 Handheld Console Screens......................................................................................29
2.1 The Run Mode Screen.......................................................................................30
2.1.1 Exposure System Displays...........................................................................31
2.1.2 The Message Area....................................................................................31
2.1.3 The Status Area.......................................................................................31
2.2 The User Defaults Screen...................................................................................32
2.3 The Exposure Defaults Screen.............................................................................33
2.4 Setting Defaults for Each Exposure Mode................................................................34
2.4.1 Auto-Time Mode......................................................................................34
2.4.2 Manual Mode.....................................................................................34
2.4.3 Default Exposure Mode..............................................................................35
Chapter 4—Power Sequences and Checks 37
1.0 Power Up Sequence for the MultiCare Platinum System....................................................37
1.1 Power Up Procedures.......................................................................................37
1.2 Start Up Procedures......................................................................................... 38
2.0 Setting Up the Main Menu.......................................................................................39
3.0 Host Verification Procedures...................................................................................40
3.1 Host Verification - MultiCare Platinum...................................................................40
4.0 The DSM Screen Overview.......................................................................................41
4.1 The Main Menu......................................................................................... 41
4.2 The Annotation Display.....................................................................................42
4.3 The Active Image Display Area............................................................................42
4.4 The Case Study Display Area...............................................................................42
5.0 The DSM Main Menu........................................................................................ 43
6.0 The Annotation Area............................................................................................. 44
6.1 DICOM Standard Support....................................................................................44
6.2 The Annotation Area Display...............................................................................44
7.0 The Image Display Area.......................................................................................... 46
7.1 The Active Image Area......................................................................................46
7.2 The Case Study Display Area...............................................................................47
8.0 DSM Shut Down Procedure................................................................................ 48
9.0 Emergency Stop Switches.......................................................................................48
Chapter 5—Preparing the System for Use 49
1.0 Table Accessories................................................................................................. 49
1.1 Installing Compression Paddles............................................................................51
1.2 Installing the Aperture......................................................................................52
1.3 Breast Platform Placement................................................................................53
1.4 Mounting the DSM Image Receptor........................................................................54
1.5 Mounting the DSM Film Scout Holder.....................................................................55
2.0 Installing Compatible Biopsy Devices..........................................................................56
2.1 Installing the Biopsy Device Holder.......................................................................56
2.2 Installing the Rear Needle Guide Mount..................................................................58
2.3 Installing the Front and Rear Needle Guides............................................................59
2.4 Positioning The Table and C-arm..........................................................................60

Chapter 6—DSM Operations 63

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1.0 Using The Image Processing Menu.............................................................................63

1.1 The Window/Level Option .................................................................................64
1.2 The Invert Option............................................................................................65
1.3 The Zoom-In Option.........................................................................................66
1.4 The Mag On Option.................................................................................... 67
1.5 The Filter Option............................................................................................68
1.6 The Tools Option............................................................................................69
1.6.1 Select Ruler Tool.....................................................................................70
1.6.2 Select the Target Tool...............................................................................70
1.6.3 Select the Calipers Tool.............................................................................71
1.7 The Custom Option..........................................................................................72
2.0 Saving The Image.................................................................................................73
2.1 Make image enhancements:................................................................................73
2.2 Save the image:..............................................................................................73
3.0 The Directory List Window......................................................................................74
4.0 The Case Study List.............................................................................................. 75
4.1 Quick Sort..................................................................................................... 75
5.0 The Image List.................................................................................................... 76
6.0 The Parameter (Search) Menu—Directory List Window.....................................................77
6.1 The Search Button...........................................................................................77
6.2 The List All Button........................................................................................... 77
7.0 Recalling A Case Study........................................................................................... 78
7.1 Initiate Search Options.....................................................................................78
7.2 Recall a Case Study—Default...............................................................................79
7.3 Recall a Case Study—Choose Image.......................................................................79
8.0 The File Manager Window.......................................................................................80
9.0 The Image List.................................................................................................... 81
10.0 Parameter (Search) Menu—File Manager Window..........................................................81
11.0 The Function Menu.............................................................................................82
12.0 DICOM Query Options.....................................................................................84
12.1 Image Display Options.....................................................................................85
12.2 DICOM Query Retrieval.............................................................................. 86
13.0 DICOM Image Retrieval Status Messages.....................................................................88
14.0 Dicom Query Alert Messages..................................................................................88
15.0 The Operation Menu............................................................................................89
15.1 Erase Images................................................................................................ 90
16.0 Copy Images..................................................................................................... 93
17.0 Move Images..................................................................................................... 95
18.0 Recall Button.................................................................................................... 96
19.0 Printing Methods................................................................................................ 96
19.1 Print Screen................................................................................................. 97
19.2 Print Film.................................................................................................. 100
20.0 The Re-Annotate Utility......................................................................................103
20.1 Re-Annotating the Image File...........................................................................103
21.0 The Auto Archive Utility......................................................................................106
21.1 DICOM Server........................................................................................ 106
21.2 Storage Commitment.....................................................................................106
21.3 Auto Archive Utility Example Sequence...............................................................107
22.0 DSM CD/DVD Archive Media............................................................................ 109
22.1 DSM CD/DVD Formatting........................................................................... 109

Chapter 7—Clinical Procedures 111

1.0 User Calibration and Verification.............................................................................111
1.1 Preset Needle Calibration.................................................................................111
2.0 Preparing The Stage............................................................................................ 113
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2.1 Mode Selection............................................................................................. 113

2.2 Entering Biopsy Instrument Parameters................................................................113
3.0 Acquiring a Single Image.......................................................................................114
3.1 System Preparation........................................................................................114
3.2 Choose the Single Image Acquisition Mode.............................................................115
3.3 Annotate the Image—Existing Patient...................................................................116
3.4 Annotate the Image—New Patient.......................................................................118
3.5 Setting X-ray Technique—Host...........................................................................119
3.6 X-ray Technique Dialog Box—DSM..................................................................120
3.7 Cover the MultiCare Platinum Control Panel...........................................................121
4.0 Prepare the Patient............................................................................................. 122
5.0 Make the X-ray Exposure.......................................................................................122
6.0 Make Window/Level Adjustments............................................................................123
7.0 Use the Enhancement Menu Options.........................................................................124
8.0 Re-position Patient............................................................................................. 124
9.0 Acquiring Stereo Images.......................................................................................125
9.1 Choose the Stereo Image Acquisition Mode............................................................125
9.2 Annotate the Image........................................................................................126
9.3 The Image Acquisition/X-ray Technique Dialog Box..................................................126
9.4 Set the Exposure Techniques.............................................................................127
9.5 Acquire the 1st Stereo Image Exposure.................................................................127
10.0 Make Window/Level Adjustments ...........................................................................128
11.0 Acquire the 2nd Stereo Image Exposure...................................................................128
12.0 Make Window/Level Adjustments ...........................................................................129
13.0 Stereo Targeting............................................................................................... 129
14.0 Lesion Targeting Sequence...................................................................................130
14.1 Select the Single Image for ScoutMarc Targeting....................................................131
14.2 Begin the Targeting Sequence..........................................................................132
14.3 Mark Reference Cursors..................................................................................133
14.4 Mark the Lesion in the 1st Image.......................................................................134
14.5 Mark the Lesion in the 2nd Image......................................................................135
14.6 Transmit the Coordinates to the Smart Window Display............................................136
15.0 Multiple Targets............................................................................................... 136
16.0 Multiple Passes................................................................................................. 137

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Chapter 8—Quality Assurance 139

1.0 System Preparation............................................................................................. 139
1.1 System Preparation........................................................................................139
1.2 Image Setup................................................................................................. 139
1.3 Compression Accuracy Test...............................................................................140
2.0 QAS Needle Test................................................................................................ 140
3.0 Mammography Phantom Test..................................................................................141
3.1 Mammography Test Setup.................................................................................141
3.2 Fiber Test................................................................................................... 142
3.3 Calcification (Speck Group) Test........................................................................142
3.4 Masses Test.................................................................................................142
3.5 Quality Control Test for DSM.............................................................................144
4.0 Quality Control Using the SMPTE Test Pattern..............................................................145
4.1 SMPTE Test Pattern Usage................................................................................145
4.2 Display Brightness and Contrast Settings...............................................................146
4.3 Procedure—Optimizing Display Brightness and Contrast.............................................147
4.3.1 Adjusting Monitor Brightness and Contrast......................................................148
4.4 Procedure—Optimizing Hardcopy Image Density and Contrast......................................148
4.5 Hardcopy Output Quality Test (Digital Only)...........................................................149
4.5.1 Objective............................................................................................. 149
4.5.2 Frequency............................................................................................ 149
4.5.3 Required Test Equipment..........................................................................149
4.5.4 Procedure............................................................................................ 149
4.5.5 Data Analysis and Interpretation.................................................................149
4.5.6 Recommended Performance Criteria and Corrective Action.................................150
4.6 Other Image Quality Checks..............................................................................150
4.6.1 High Contrast Resolution...........................................................................150
4.6.2 Low Contrast Resolution...........................................................................150
4.6.3 Spatial Linearity.....................................................................................150
4.6.4 Uniformity and Artifacts...........................................................................150
4.6.5 Display of All Information..........................................................................150
Chapter 9—Care and Maintenance 151
1.0 Introduction...................................................................................................... 151
2.0 Care and Cleaning............................................................................................... 151
2.1 Cleaning and Disinfection.................................................................................151
2.2 Cleaning Solution Recommendations....................................................................151
2.3 Care of Plastic Components..............................................................................151
2.4 MultiCare Platinum Patient Table.......................................................................152
2.5 MultiCare Platinum and DSM Console..............................................................152
3.0 System Performance Checks..................................................................................152

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Appendix A—Specifications 153

1.0 MultiCare Platinum Table and Generator Specifications..................................................153
1.1 System Performance.......................................................................................153
1.2 Mechanical Specifications.................................................................................153
1.3 MultiCare Table and Generator Dimensions............................................................154
1.4 Compression................................................................................................ 154
1.5 Generator................................................................................................... 155
1.6 Shielding Specifications...................................................................................155
1.7 X-ray Tube Specifications.................................................................................156
1.8 Environmental.............................................................................................. 156
1.9 Technique Accuracy.......................................................................................157
2.0 DSM Specifications........................................................................................ 157
2.1 System Features............................................................................................ 157
2.2 Digital Image Receptor....................................................................................157
2.3 DSM Cart Dimensions................................................................................. 158
2.4 DSM Workstation Dimensions.......................................................................158
2.5 DSM Computer Dimensions.......................................................................... 159
2.6 DSM Monitor Specifications......................................................................... 159
3.0 Handheld Console Specifications.............................................................................160
4.0 Regulatory and Safety.......................................................................................... 160
Appendix B—Alerts, Alert Codes and Messages 161
1.0 DSM Console Alert Messages...................................................................................161
2.0 Handheld Console Alert Codes and Messages...............................................................163
Appendix C—Data Sheets 165
1.0 SMPTE Pattern Chart........................................................................................... 165
Index 167

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List of Figures

Figure 1-1: The MultiCare Platinum System.........................................................................2

Figure 1-2: DSM Operator Workstation...............................................................................3
Figure 1-3: Location of Labels - DSM Cart (Refer to prior page for additional compliance statements)..........7
Figure 1-4: Location of Labels - Operator Workstation............................................................8
Figure 2-1: The Table Control Panel................................................................................12
Figure 2-2: The Needle Guidance Stage Assembly................................................................15
Figure 2-3: Stage Display Modes.....................................................................................17
Figure 2-4: DSM Cart..................................................................................................21
Figure 2-5: DSM Side View (Shelf release).........................................................................21
Figure 2-6: Major Components - Workstation......................................................................22
Figure 2-7: Monitor Functions........................................................................................23
Figure 2-8: DSM Computer (Front View)............................................................................24
Figure 2-9: The DSM Trackball.......................................................................................25
Figure 3-1: The Handheld Console Front Panel...................................................................27
Figure 3-2: Control Panel in Run Mode.............................................................................30
Figure 3-3: The User Defaults Screen...............................................................................32
Figure 3-4: Overview of the Exposure Defaults Screen..........................................................33
Figure 3-5: Auto-Time Mode Options...............................................................................34
Figure 3-6: Manual Mode Options....................................................................................34
Figure 3-7: Default Exposure Mode Options.......................................................................35
Figure 4-1: Generator Package Circuit Breaker...................................................................37
Figure 4-2: Multiple White Field Dialog Box.......................................................................38
Figure 4-3: The Main Menus..........................................................................................39
Figure 4-4: The DSM Screen.......................................................................................... 41
Figure 4-5: Image Recall Drop-down Menu Options...............................................................47
Figure 4-6: Emergency Stop Switches...............................................................................48
Figure 5-1: Installing Compression Paddles........................................................................51
Figure 5-2: Installing the Aperture..................................................................................52
Figure 5-3: Breast Platform Adjustment...........................................................................53
Figure 5-4: Mounting the DSM Image Receptor....................................................................54
Figure 5-5: DSM Film Scout Holder Installation....................................................................55
Figure 5-6: Installing the Biopsy Holder............................................................................57
Figure 5-7: Installing the Rear Needle Guide Mount..............................................................58
Figure 5-8: The Front and Rear Needle Guides....................................................................59
Figure 5-9: C-arm Position Adjustment.............................................................................61
Figure 6-1: Image Processing Menu.................................................................................63
Figure 6-2: Window/Level Option...................................................................................64
Figure 6-3: Invert Option............................................................................................. 65
Figure 6-4: Zoom-In Option.......................................................................................... 66
Figure 6-5: Mag On Option........................................................................................... 67
Figure 6-6: Filter Option.............................................................................................. 68
Figure 6-7: Tools Option.............................................................................................. 69
Figure 6-8: The Ruler Tool........................................................................................... 70
Figure 6-9: The Target Tool..........................................................................................70
Figure 6-10: The Calipers Tool.......................................................................................71
Figure 6-11: The Custom Option.....................................................................................72
Figure 6-12: Archived Image Warning...............................................................................73

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Figure 6-13: The Directory List Window............................................................................74

Figure 6-14: The Case Study List....................................................................................75
Figure 6-15: The Image List..........................................................................................76
Figure 6-16: The Parameter (Search) Menu........................................................................77
Figure 6-17: Thumbnails in the Case Study Display Area........................................................78
Figure 6-18: No Match Found Dialog Box...........................................................................78
Figure 6-19: The File Manager Window............................................................................80
Figure 6-20: The Function Menu....................................................................................82
Figure 6-21: DICOM Queries Preferences dialog box.............................................................85
Figure 6-22: DICOM Query Dialog Box...............................................................................86
Figure 6-23: DICOM Query Results and Retrieve dialog box.....................................................87
Figure 6-24: DICOM Query Status Message.........................................................................88
Figure 6-25: The Operation Menu...................................................................................89
Figure 6-26: The Device Is Not Ready Dialog Box.................................................................90
Figure 6-27: No Match Found Dialog Box...........................................................................90
Figure 6-28: Erase Confirmation Dialog Box.......................................................................91
Figure 6-29: Image Erasure Confirmation..........................................................................92
Figure 6-30: File Copy Confirmation................................................................................94
Figure 6-31: Copy Image Conformation Dialog Box...............................................................94
Figure 6-32: The Move Selected Images Confirmation Dialog Box..............................................95
Figure 6-33: The Move Displayed Images Confirmation Dialog Box.............................................95
Figure 6-34: Print Screen Dialog Box................................................................................97
Figure 6-35: Print Screen Dropdown Menu Options...............................................................98
Figure 6-36: Print Sequence Dialog Box (Floppy Disk option shown)...........................................99
Figure 6-37: Print Film Dialog Box.................................................................................100
Figure 6-38: Available Film Formats..............................................................................101
Figure 6-39: Print Sequence Completed Dialog Box.............................................................102
Figure 6-40: Re-Annotate Dialog Box..............................................................................104
Figure 6-41: Re-Annotate Image File Screen.....................................................................104
Figure 6-42: No New Cases to Archive Dialog Box...............................................................107
Figure 6-43: Number of Cases to Archive Dialog Box............................................................107
Figure 6-44: Archive Progress Dialog Box.........................................................................108
Figure 6-45: Archive Complete Dialog Box.......................................................................108
Figure 7-1: Z Zero Presets Mode Display..........................................................................111
Figure 7-2: Main Menu Acquire Image Selections...............................................................114
Figure 7-3: The Patient Annotation Dialog Box..................................................................116
Figure 7-4: The Patient Worklist...................................................................................117
Figure 7-5: Image Acquisition/X-ray Technique Dialog Box....................................................119
Figure 7-6: Clear Plastic Banded Bag Installation...............................................................121
Figure 7-7: Window / Level Histogram Example.................................................................123
Figure 7-8: Main Menu Acquire Stereo Selections...............................................................125
Figure 7-9: Image Acquisition/X-ray Technique—512 Stereo Image Screen.................................126
Figure 7-10: Image Acquisition 512 Stereo Image...............................................................128
Figure 7-11: Image Acquisition—Stereo Acquisition Complete.................................................129
Figure 7-12: Stereo Targeting Dialog Box.........................................................................129
Figure 7-13: Selecting ScoutMarc Targeting.....................................................................131
Figure 7-14: Reference Cursors Positioned Correctly? Dialog Box.............................................132
Figure 7-15: Reference Point Cursor Placement Example......................................................132
Figure 7-16: Marking the Reference Cursors.....................................................................133
Figure 7-17: Lesion Targeting......................................................................................135
Figure 8-1: The RMI 156 Phantom.................................................................................143

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Figure 8-2: SMPTE Test Pattern....................................................................................145

Figure 8-3: 5% and 95% Inset Test Patches.................................................................146
Figure 8-4: Filter Settings —SMPTE Test Pattern................................................................147
Figure A-1: MultiCare Platinum Table and Generator Dimensions............................................154
Figure A-2: DSM Cart Dimensions..................................................................................158
Figure A-3: DSM Workstation Dimensions.........................................................................158

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List of Tables

List of Tables

Table 1-1: Certifiable Components..........................................................................................9

Table 2-1: Stage Display Selection Matrix................................................................................18
Table 2-2: The DSM Cart Assembly..................................................................................21
Table 2-3: DSM Monitor Control Descriptions......................................................................23
Table 2-4: DSM Keyboard............................................................................................. 26
Table 3-1: The Handheld Console Front Panel..........................................................................28
Table 3-2: Handheld Console Panel Display Screens.............................................................29
Table 3-3: Exposure System Choices in the Run Mode...........................................................31
Table 3-4: Choices in the User Defaults Screen.........................................................................32
Table 4-1: DSM Main Menu Descriptions...........................................................................43
Table 4-2: Annotation Area Field Lengths................................................................................44
Table 4-3: Annotation Area Data Field Descriptions...................................................................45
Table 4-4: Image Processing Menu Choice Descriptions.........................................................46
Table 5-1: MultiCare Platinum Compression Paddles..................................................................50
Table 5-2: Breast Platform Position/Compression Thickness..........................................................53
Table 6-1: Case Study List Column Headings......................................................................75
Table 6-2: The Image List’s Annotation Parameters....................................................................76
Table 6-3: Methods of Recall........................................................................................78
Table 6-4: File Management Functions...................................................................................80
Table 6-5: Images List Annotation Parameters..........................................................................81
Table 6-6: Function Menu Options..................................................................................83
Table 6-7: Operation Menu Functions..............................................................................89
Table 6-8: Erase Image Confirmation Actions............................................................................92
Table 6-9: File Management Confirmation Actions.....................................................................94
Table 6-10: Disk Format Options—Pros and cons................................................................109
Table 6-11: Disk Format Options—by Media Type...............................................................110
Table B-1: Power Up Messages.....................................................................................161
Table B-2: Exposure Messages............................................................................................ 161
Table B-3: System Operation Faults.....................................................................................162
Table B-4: Monitoring/Error Messages .............................................................................163

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Preface
Intended Use

Preface

1.0 Intended Use

The MultiCare Platinum device combines the function of a standard x-ray mammography
unit with that of a stereotactic lesion localization system to produce a device that has
specific application in first localizing, and then giving a physician the capacity of
performing Fine Needle Aspiration or core biopsy of lesions determined to be suspicious
through prior mammographic examination.

2.0 Quality Control

All Quality control tests must be performed within the appropriate time frame.

3.0 User Training

Hologic does not accept responsibility for injury or damage associated with improper or
unsafe system operation. Your Hologic Representative can arrange for training by a clinical
application specialist.
You should refer to this Operator’s Manual for directions on how to use the MultiCare
Platinum.

4.0 Using the Operator’s Manual

The MultiCare Platinum Operator’s Manual provides the following information:
Chapter 1—General Information. This chapter provides an overview of the mammography
system, including component descriptions, patient and user safety, interlocks, and
compliance information.
Chapter 2—Using the MultiCare Platinum System. This chapter contains the use and
functions of table component controls and indicators.
Chapter 3—Using the Handheld Console. This chapter contains the use and functions of the
Handheld Console.
Chapter 4—Power Sequences and Checks. This chapter details the power up and down
sequences and checks.
Chapter 5—Preparing the System for Use. This chapter contains instructions for preparing
the MultiCare Platinum for use.
Chapter 6—DSM Operations. This chapter describes DSM operations.
Chapter 7—Clinical Procedures. This chapter suggests a sequence for stereotactic
procedures.
Chapter 8—Quality Assurance. This chapter describes QAS test procedures.
Appendix A—Specifications. This appendix contains product specifications.
Appendix B—Alerts, Alert Codes and Messages. This appendix describes the system’s
Alarms, Alarm Codes, and messages.
Appendix C—Data Sheets. This appendix contains data sheets used with the MultiCare
Platinum System.

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Terms

5.0 Terms
AEC Automatic Exposure Control.
B.E.M. Breast equivalent material
MQSA Mammographic Quality Standards Act

6.0 Warnings, Cautions, and Notes

6.1 Definitions
Definitions of Warnings, Cautions and Notes used throughout this manual are as follows:

WARNING! This alerts you to procedures that you must follow precisely to
avoid causing potentially serious or fatal injury to yourself or
others.

Warning: Warnings indicate procedures that you must follow precisely to

avoid injury to yourself or others.

Caution: Cautions indicate procedures that you must follow precisely to avoid
damage to equipment, loss of data, or corruption of files in software
applications.

Note… Notes indicate important information that must be followed to ensure the
proper operation of the system.

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Chapter 1—General Information
Introduction

Chapter 1—General Information

1.0 Introduction
The MultiCare Platinum is a breast biopsy system specifically designed for prone
stereotaxis. It is used to accurately target a lesion and guide the physician in the precise
insertion of a needle into the lesion. This is accomplished by acquiring two views (stereo
images) of the lesion area from which three-dimensional coordinates of the lesion are
determined. The images are acquired digitally, using the Digital Spot Mammography
(DSM) system.
Use of the MultiCare Platinum for biopsy procedures offers the following significant benefits:
• Reduced patient anxiety and minimal vasovagal reactions result from patient being
supported in prone position and performing procedures out of patient’s direct
sight.
• Full 360° breast access possible with the C-arm’s 180° rotation capability, plus ability
to position patient’s head to the right or to the left.
• The use of a more comfortable approach (from below), reducing the skin to lesion
tissue distance.
• Maximum image quality results from the system’s ability to enhance digitally-acquired
images with the DSM.
• Minimal image acquisition time with the use of the DSM.

Caution: United States Federal Law restricts this device to use by or on the order
of a physician.

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Chapter 1—General Information
Unit Description

2.0 Unit Description

The MultiCare Platinum System consists of four assemblies:
• The MultiCare Platinum Table, (with C-arm)
• The Generator Package
• The Digital Spot Mammography (DSM) System, and
• The Handheld Console.
Use the following legend and illustration for component identification.

Figure 1-1: The MultiCare Platinum System

Legend for Figure 1-1

1. Patient Table
2. X-ray Tube
3. Tube Arm
4. Compression Arm
5. Needle Guidance Stage
6. DSM Image Receptor
7. Generator Package
8. Handheld Console
9. DSM Cart

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Chapter 1—General Information
Unit Description

2.1 The MultiCare Platinum Table

The MultiCare Table is used to position and support the patient and contains the
components and accessories necessary to obtain high quality stereo images of a lesion in
the breast. The Table also contains the Needle Guidance Stage. The Needle Guidance Stage
positions a Biopsy Instrument/Needle and guides the physician in its insertion.

2.2 The Generator Package

The Generator Package provides power to the table and is used for tube and exposure
control and provides for the transmission of information between the Handheld Console and
the DSM. It consists of a high-voltage generator, tube control assembly, interface, and
microprocesser.

2.3 The DSM Console

The DSM Console is the operator interface that contains the DSM components that collect,
process, and display scout and stereotactic images and calculates lesion target coordinates
based on user input. It consists of a computer, high-resolution monitor, power supply,
keyboard, trackball, and CCD camera assembly.
The DSM Console may have two configurations:
• The DSM Cart Assembly (see #9 Figure 1-1, p. 2)
• The DSM Operator Workstation (Figure 1-2)

Figure 1-2: DSM Operator Workstation

2.4 The Handheld Console

The Handheld Console is a portable keyboard/LCD display that interfaces with the
generator and allows the user and service engineers to scroll through on-screen data fields,
change exposure settings, clear alerts, and initiate X-ray exposure.

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Operator’s
Chapter 1—General Information
Safety

3.0 Safety
This Operator’s manual should be read and understood in its entirety before turning the unit
On. Always follow all the instructions in this manual.

The system is classified as CLASS I, TYPE B permanently connected equipment as per IEC
601-1. There are no special provisions to protect the system from flammable anesthetics
or ingress of liquids.

3.1 Radiation Safety

When operating the MultiCare Platinum System, keep in mind the health hazards of
unwanted X-rays. The technologist must be familiar with the published data on radiation
safety.

Warning: Observe all operating and safety instructions before making an X-

ray.

Warning: This X-ray unit may be dangerous to patient and operator unless
safe exposure factors and operating instructions are observed.
This unit is for use by qualified personnel only.

3.2 Technologist and Patient

Only qualified operators should use this machine. Operators should be well-versed in the
basic principles of mammography before attempting to carry out the instructions contained
in this manual. Do not use any heating source for patient comfort, i.e. heating pad, on the
system. Minimizing exposure to the patient by limiting the number of exposures is
recommended.

WARNING! Lethal voltages are present within the interior of this unit. Do
not open any of the panels. Never operate this device in
zones where there is a risk of explosion. Electrical equipment
used in the presence of flammable anesthetics or oxygen may
cause an explosion.

WARNING! It is the responsibility of the user to correct anomalies or

abnormal operation before the unit is used, and to arrange
for preventive maintenance by an authorized service
engineer.

Warning: In the event of loss of power always remove the patient from the
unit before re-applying power.

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Chapter 1—General Information
Safety

Warning: To avoid patient injury, after positioning the patient and applying
compression, place the Keyswitch in the LOCKOUT position to
prevent inadvertent C-arm movement during procedures.

Warning: Never leave the patient unattended during the exam, especially
when in contact with the stereotactic unit.

Warning: Keep the patient’s hands away from any operator controls (i.e.,
all buttons and switches) at all times.

Warning: Motorized equipment. Use care when adjusting for patient use.
Observe equipment and patient at all times during set up.

Warning: Do not attempt to move heavy equipment components alone. Be

sure to have the necessary machinery and personnel available to
move the system safely. Use proper lifting techniques to avoid
personnel injury.

Caution: Do not remove the control panel cover. To prevent fluids from penetrating
the cover, a Clear Plastic Banded Bag (PN 2-700-0072) must be installed
over the control panel.

Caution: This is a medical device and should not be considered to be a general-

purpose computer. Users or service/administrative personnel may not
amend, configure, or modify any hardware or software on this medical
device with anything other than Hologic-approved components or
software, including anti-virus software. This device should be installed
behind the institution firewall for network security and anti-virus
protection. No ongoing computer virus protection or network security for
this medical device is provided (e.g., a computer firewall). Network
security and anti-virus provisions are the ongoing responsibility of the user

Caution: Do not block equipment air vents or damage may occur.

3.3 Emergency Stop Switches

Two Emergency Stop switches are located at the end of the tube arm (one on each side)
within easy reach of the user. These switches disable all C-arm and table Up/Down
movement. See “Emergency Stop Switches” on page 48 for locations.

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Operator’s
Chapter 1—General Information
Compliance

4.0 Compliance

4.1 Compliance Requirements

The manufacturer is responsible for the effects of safety, reliability and performance of this
equipment with the following provisions:
• The electrical installation of the room complies with the appropriate requirements.
• The equipment is used in accordance with instructions for use.
• Assembly operations, extensions, re-adjustments, modifications, or repairs
are performed by authorized persons only.
• The installed network and communications equipment must comply with an IEC
Standard and the complete system (network/communications equipment and MultiCare
Platinum System) must be installed to comply with IEC 601-1 AND IEC 601-1-1.

4.2 Compliance Statements

The manufacturer states that this device is manufactured/conforms to:
• CAN/CSA: ISO 13485:1998 / ISO 13485:1996
• FDA, 21 CFR [Parts 820, 900 and 1020]
• IEC 601-1:1988 +A1+A2:1995 +A13:1996 Medical Electrical Equipment - General
requirements for safety
• IEC 601-1-1:2000-12Medical electrical equipment - Collateral standard: Safety
requirements for medical electrical systems
• IEC 601-1-2:2001 Medical electrical equipment - Collateral standard: Electromagnetic
compatibility for medical electric systems
• IEC 601-1-3:1994 Medical electrical equipment - Collateral standard: Requirements for
radiation protection in diagnostic X-ray equipment
• IEC 601-1-4:1996 +A1:1999 Medical electrical equipment - Collateral standard:
programmable electrical medical systems
• IEC 601-2-7:1987 Medical electrical equipment – Particular requirements for the safety
of high-voltage generators of diagnostic x-ray generators.
• IEC 601-2-28: 1993-03Medical electrical equipment – Particular requirements for the
safety of x-ray source assemblies and x-ray tube assemblies for medical diagnosis
• IEC 601-2-32:1994 Medical electrical equipment - Particular requirements for the safety
of associated equipment of x-ray equipment
• IEC 601-2-45:2001 Medical electrical equipment – Particular requirements for the safety
of mammographic x-ray equipment and mammographic stereotactic devices
• UL 2601: Medical Electrical Equipment, Part 1 – General Requirements for Safety
• CSA: Medical Electrical Equipment Part 1: C22.2601 No. 601.1 –M9—
General Requirements for Safety
The MultiCare Platinum conforms to all applicable FDA regulations. Compliance Labels are
affixed to the unit at several points (Figure 1-3, p. 7).

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Chapter 1—General Information
Compliance

Figure 1-3: Location of Labels - DSM Cart (Refer to prior page for additional compliance
statements)

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Operator’s Manual
Chapter 1—General
Information Compliance

Figure 1-4: Location of Labels - Operator Workstation

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Chapter 1—General Information
Compliance

4.3 Certifiable Components

The following certifiable components are identified using individual serial numbers in
addition to the serial number of the overall MultiCare Platinum System.

Table 1-1: Certifiable Components

Item Manufacturer
X-ray Tube* Varian Eimac
Beam Limiting Device Hologic
High Voltage Generator Hologic
Handheld Console Hologic
Image Receptor Support Device Hologic
MultiCare Platinum Table Hologic

* Documents prepared by component suppliers, which are furnished with this equipment,
include:
• Varian Eimac M-149 X-ray Tube Data
• Instructions for Assemblers and Users

Notes… When replacing a certified component that is concealed by a surface

(i.e., cover, panel, etc.), the component’s duplicate label on the exterior
of the unit must be replaced at the time of service.
When replacing a surface (i.e., cover, panel, etc.) that has a certified
component duplicate label(s), a label(s) that represents the certified
component label(s) must be placed on the new surface at the time of
service.

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Operator’s Manual
Chapter 1—General
Information Compliance

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 Operator’s
Chapter 2—Using the MultiCare Platinum System
Introduction

Chapter 2—Using the MultiCare Platinum System

1.0 Introduction
The MultiCare Platinum System functions are accomplished by control of the Table
platform, the Needle Guidance Stage, the DSM Console, and the Handheld Console. The
system components and controls are described below, with the exception of the Handheld
Console, which is covered in “Chapter 3—Using the Handheld Console” on page 27.

2.0 The Table Platform

The patient is positioned on the padded Table for the clinical procedure. Pullout footrests,
at either end of the Table, support the patient’s legs. This allows left or right head
positioning and grants 360° access around either breast. A 10" circular aperture through the
center of the Table allows the patient’s breast to be pendulant within the work area. Two
portable padded cushions are normally placed at the edges where the height of the table
transitions around the aperture. A motorized drive mechanism allows the Table surface to
be placed between 34 and 57 inches from the floor.
The work station beneath the table platform contains the C-arm which is composed of an X-
ray Tube Arm and a Compression Arm. The X-ray Tube Arm supports the X-ray tube, the
collimator, and the DSM Image Receptor, while the Compression Arm supports the Needle
Guidance Stage, the Compression Device, and the Breast Platform. The Tube Arm and
Compression Arm rotate in unison between 0° and 180° about the central axis of the
patient table. The Compression Device is activated by use of directional control buttons or
footswitches that move the compression paddle closer to, or farther from, the Breast
Platform. The DSM Image Receptor acquires single and stereo images, and converts them
for digital display.

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Operator’s
Chapter 2—Using the MultiCare Platinum System
MultiCare Platinum Table Control Panel

3.0 MultiCare Platinum Table Control Panel

The Control Panel on the MultiCare Platinum Table provides control switches for:

• Table Height
• C-arm Rotation • Compression Movement
• C-arm Position • Work Area Lamps

The Control Panel rotates to keep the C-arm from blocking the controls as it is rotated. A
Panel release handle permits the entire panel to rotate into one of five positions.

Figure 2-1: The Table Control Panel

Legend for Figure 2-1 - The Table Control Panel

1. Control Panel Handles
2. C-arm Position Switch
3. C-arm UP/DOWN
4. C-arm Rotation Release
5. Safety Keyswitch
6. Lamp Switch
7. Compression UP/DOWN
8. Table UP/DOWN

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Chapter 2—Using the MultiCare Platinum System
MultiCare Platinum Table Control Panel

3.1 Using the MultiCare Platinum Table Controls

The push-button controls and switches on the MultiCare Platinum Control Panel are
described in the following section.

C-arm Position Switches

These identical push button switches on either side of the Control Panel allow movement of
the C-arm in the left/right and front/back directions. Use this control to position the C-arm
accurately under the breast aperture.

C-arm Up/Down Switches

These identical push button switches on either side of the Control Panel allow up and down
movement of the C-arm. Use this control to move the C-arm to the necessary height for the
exam.

Note… Table controls, such as Compression and C-arm Up/Down are available on
the table’s foot controls.

C-arm Rotation Switches

These identical push button switches on either side of the Control Panel allow rotation of
the C-arm. Use this control to move the X-ray tube and Needle Guidance Stage to the
appropriate approach angle.

Safety Keyswitch
A key operated, two-position switch, with a lighted indicator, prevents inadvertent control
actuation during a clinical procedure. When the Keyswitch is ON, all Control Panel
Operations are functional. When the Keyswitch is moved to the LOCKOUT position, only
the Light Up/Down control is functional.

Warning: To avoid patient injury, after positioning the patient and applying
compression, place the Keyswitch in the LOCKOUT position to
prevent inadvertent C-arm and table movement during procedures.

Note… The Safety Keyswitch does not lock-out the Lamp Controls.

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Operator’s
Chapter 2—Using the MultiCare Platinum System
MultiCare Platinum Table Control Panel

Lamp Switch
This lamps switch adjusts the intensity of the two work area Lamps that are mounted on
the Tube Arm.

Compression Up/Down Switch

These two push button switches on the Control Panel adjust the position of the compression
accessory. Use the DOWN switch to apply compression (movement toward the breast
platform), or the UP switch to release compression (movement toward the X-ray tube).

Note… The Compression Up/Down functions are also available using the
Footswitch accessory.

Table Up/Down Switch

These two push button switches allow up and down movement of the Table. Lower the Table
during patient positioning, then raise it to a suitable working height during the procedure.

3.2 Table Levelers

The Table has four levelers - one on each corner - which are used to level the Table during
initial set up. If “self-shifting” of the C-arm occurs when the Rotation Release Button or
C-arm Centering Button is depressed, the Table requires leveling.

Note… If the MultiCare Platinum system is moved, be sure to consult a

service engineer to recheck the Table and level it as necessary.

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 Operator’s
Chapter 2—Using the MultiCare Platinum
System The Needle Guidance Stage
Operation

4.0 The Needle Guidance Stage Operation

The DSM program calculates the X, Y, and Z coordinates for each lesion targeted by the
user. The coordinates are then transmitted to both Smart Window Display panels, located
on either side of the Stage assembly. Using the Stage controls, the operator then moves the
needle mount to the target coordinates. During Stage movement, the operator receives
continuous feedback, via the Smart Window Displays, indicating current Biopsy Instrument/
Needle position relative to the target position. The Stage is moved first to the X and Y
coordinates, which places the Biopsy Instrument/Needle directly in front of the target
lesion. Then, the Biopsy Instrument/Needle is inserted manually to the target Z depth.

4.1 The Needle Guidance Stage Assembly

The Needle Guidance Stage Assembly (shown in Figure 2-2) is used to position the needle to
the target X, Y and Z coordinates obtained through the stereotactic localization procedure.
Stage movement is accomplished by motorized travel in the X and Y directions, or by
manually rotating X and Y knobs located on either side of the Stage assembly. Stage
movement in the Z direction is accomplished only by manual movement.

Figure 2-2: The Needle Guidance Stage Assembly

Legend for Figure 2-2 - The Needle Guidance Stage Assembly

1. Manual Z-Axis Control 2. Motor Control Keypad

3. Stage Keypad 4. Manual Y-Axis Control
5. Manual X-Axis Control 6. Smart Window Display
7. Needle Mount 8. Z-Axis Lock
9. Manual Compression Knob

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Chapter 2—Using the MultiCare Platinum System
The Stage Display Panels

5.0 The Stage Display Panels

Two Stage Display panels, one mounted on each side of the Stage assembly, convey target
and current Stage position information to the operator during the stereotactic procedure. The
Stage Display will show one of four user selected operating modes:
• Needle Core Biopsy (NCB) Mode
• Fine Needle Aspiration (FNA) Mode
• Wire Localization (WL) Mode
• Z Zero Presets Mode
The Z ZERO Preset Mode is a set-up mode which permits the user to store preset Biopsy
Instrument/Needle parameters for each of the three clinical modes. The three clinical modes
correspond to the procedures applicable to the MultiCare Platinum System. The Stage
Display screens for each mode are shown in Figure 2-3, p. 17.
The three clinical modes all show the following data:
• Current Stage X, Y and Z position
• Numeric display of the Target (or Pass) X, Y and Z coordinates
• Differentials between the target X, Y and Z and the Stage X, Y and Z
• Compression Thickness (in mm)
The DSM will send zeros to Smart Window, stage line, whenever a new patient is detected.
When Needle Core Biopsy (NCB) is the selected mode, the screen will show a field for the
needle Stroke, as well as a field for the “Stroke Margin”. The user enters the biopsy device’s
needle stroke before the procedure.

Note… Stroke Margin is the distance between the end of the Biopsy Instrument/
Needle tip, after firing, and the MultiCare Platinum breast platform surface.
When Fine Needle Aspiration (FNA) or Wire Localization (WL) are the selected modes, the
screen will show a field for the required “Minimum Needle Length”. This length is
determined by the stereotactic calculation.
For each of the clinical operating modes, there is a corresponding Graphic display which
can be selected by the operator. The Graphic display uses symbols to illustrate needle tip
position relative to target coordinates. The Graphic Display shows X and Y position of the
Biopsy Instrument/Needle tip relative to the target X and Y coordinates, Z-position of the
Biopsy Instrument/Needle tip in relation to the target Z coordinate, relative measurement
aids, and in Needle Core Biopsy mode only, the Stroke Margin.

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Chapter 2—Using the MultiCare Platinum System
The Motor Control Keypad

Figure 2-3: Stage Display Modes

6.0 The Motor Control Keypad

The Stage has two identical 3-button keypads, on one side of the Stage assembly. These
motor control keypads permit the operator to initiate motor-assisted stage movement. There
are three motor-assisted destination options:

Z-Position Key

Moves the needle mount to the correct position for zeroing the needle length on
the manually-controlled Z axis. X axis moves to 0.0 mm; Y axis moves to +4.0
mm.

Target Key

Moves the Stage mount to the selected X and Y coordinate. The DSM can calculate up to 6
sets of coordinates, all of which can be transmitted to the Smart Window.

Home Position Key

Moves the needle mount, in the X and Y axis, out of the X-ray beam path to obtain
unobstructed images.

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Chapter 2—Using the MultiCare Platinum System
The Stage Keypad

7.0 The Stage Keypad

The Stage has two identical 6-button keypads on the side of each Display. These buttons
permit the operator to choose the operational mode, preset Biopsy Instrument/Needle
stroke parameters, perform the Z zero sequence, and make target selections.

Z Zero Key
This key is used to calibrate the length of an installed Biopsy Instrument/Needle prior to
performing the clinical procedure. Bring the Biopsy Instrument/Needle tip up to the
reference point (the inside surface edge of the biopsy paddle) and press the Z ZERO button
to register the 0.0 mm on the Z stage line.

Graphic/Numeric Key
Use this key to switch the screens between Graphic display and Numeric (tabular listing)
display. The Graphic display uses symbols and numbers to represent target position and
actual Biopsy Instrument/Needle tip position. The Numeric display uses numbers only to
convey the same information.

Cursor Key
This key is used in conjunction with the Enter Key to make selections on the display. Press
the Cursor key to move a highlight between selectable fields. The choice is selected when
it is displayed in reverse video.

Enter Key
Use this key to make selection after a field has been highlighted using the Cursor key. The
following matrix provides additional information for selecting and changing each available
Stage Display item.

Table 2-1: Stage Display Selection Matrix

Item Selectable From: Available Choices:

Mode Numeric display only Needle Core Biopsy (NCB)
Fine Needle Aspiration (FNA)
Wire Localization (Wire Loc) Z
Zero Preset
Stroke Needle Core Biopsy Mode only 10.0 to 25.0 mm (in 1.0 mm increments)
Target Radius Graphic Mode only 3.0, 5.0, 7.5, 10.0 or 15.0 mm

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Chapter 2—Using the MultiCare Platinum System
The Stage Keypad

Next Target Key

Press this key to sequence the X, Y and Z coordinate readouts to the next set of
target coordinates (up to 6 sets). Each set of target coordinates (Multi-Target or
Multi-Pass) is labeled sequentially on the Target Line as: A, B, C, D, E or F.

Motor Enable Key

Press and hold this key with one of the three Stage Motor Control keys (Z Position, Target,
Home) to initiate motor assisted Stage movement. The Motor Enable key must be held until
Stage movement stops, otherwise an error message will display on the Stage Display Panel.

Note… Motor controls are available for the X- and Y-axis coordinates only. The
Z axis position, or depth, is achieved by turning the manual Z axis
Control knob.

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Operator’s
Chapter 2—Using the MultiCare Platinum System
The Manual Axis Controls (X, Y, and Z axis)

8.0 The Manual Axis Controls (X, Y, and Z axis)

The following paragraphs detail the manual controls on the Stage for X, Y, and Z axis
movement.

X Axis Control
The X axis control moves the stage horizontally across the Compression Paddle’s biopsy
window (as viewed from the X-ray tube). When the X axis is positioned in line with the
biopsy paddle’s reference, the X axis Stage position indicates 0.0 mm.
Use this manual movement method any time in place of the motor-assist method.

Y Axis Control
The Y-axis control moves the stage vertically within the Compression Paddle’s biopsy
window. When the Y axis is positioned directly in line with the biopsy paddle’s reference
point, the Y axis Stage position indicates 0.0 mm. Moving the Y axis down (positive
movement) increases the displayed Y value, while moving the Y axis up (negative
movement) decreases the displayed Y value.
Use this manual movement method any time in place of the motor-assist method.

Z Axis Control
The Z axis control moves the needle mount into, or out from, the compression paddle’s
biopsy window. When the needle tip is at the level of the reference point on the biopsy
paddle, the Z axis Stage position reads 0.0 mm. Moving the Z axis toward the compression
paddle (positive movement) increases the displayed Z value, while moving the Z axis away
from the compression paddle (negative movement) decreases the displayed Z value.
The Z axis must be reset or zeroed before the display can accurately show the needle depth
(Stage Z value). First insert the needle guides, then move the Stage to align the Biopsy
Instrument/Needle tip the reference point on the Biopsy Compression Paddle. Press the Z
ZERO button to initialize the Z axis (the Z stage position indicates 0.0 mm).

9.0 The DSM System Controls and Display

The following paragraphs are designed to introduce the major components of the DSM
System and familiarize the user with the necessary controls and indicators which may be
used while operating the system.
The user should be familiar with operating a personal computer system, using internal and
external storage media (DVDs, CDs, floppy disks, etc.), and using external computer
peripherals (keyboard, trackball, printers). For detailed instructions, always refer to the
device manufacturer’s documentation that is shipped with each system.

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Chapter 2—Using the MultiCare Platinum System
The DSM System Controls and Display

9.1 DSM Cart Assembly

Table 2-2: The DSM Cart Assembly

Figure 2-5: DSM Side View (Shelf release)

Figure 2-4: DSM Cart

Legend for Figure 2-4 and Figure 2-5:

1. Cart
2. Monitor
3. Trackball
4. Keyboard
5. Computer
6. Power Supply (Not shown)
7. Shelf Release Mechanism

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Operator’s
Chapter 2—Using the MultiCare Platinum System
The DSM System Controls and Display

9.2 DSM Workstation

Figure 2-6: Major Components - Workstation

Legend for Figure 2-6

1. Handheld Console
2. Monitor
3. Trackball
4. Keyboard
5. Computer
6. Power Supply

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Chapter 2—Using the MultiCare Platinum System
The Digital Image Receptor

10.0 The Digital Image Receptor

The Digital Image Receptor mounts to the host system in place of a conventional film image
receptor. The Digital Image Receptor contains solid state electronic circuitry which
converts an X-ray image to digital data, which is then displayed at the DSM Console.

11.0 The Handheld Console

The Handheld Console consists of a keypad and LCD screen. Refer to “Chapter 3—Using the
Handheld Console” on page 27 for detailed operation.

12.0 The DSM Monitor

The DSM uses an 18-inch high resolution monochrome Flat Screen Monitor which is
capable of displaying 256 levels of gray. The controls are described below, and illustrated
in Figure 2-7.

Table 2-3: DSM Monitor Control Descriptions

Control Description
Control Dial: The Control Dial is a multi-functional device located behind the LED Indicator on
the right side of the front bezel. It has three movements - rotate upward, rotate
downward and press inward as a button.
Power On/Off: Press the Control Dial to power the unit on from the off stage (the LED is Off). To
turn the power Off, press the Control Dial and hold for at least 1 second until the
LED turns Off.
On Screen Display While the monitor is on (green LED and image on the screen), pressing on the
(OSD) Control: Control Dial activates the OSD. While the OSD menu is active, use the three way
movements of the Control Dial to adjust the monitor.
LED Indicator: The LED Indicator turns green when the Monitor is turned ON and the power cord is
properly attached. It turns amber when the monitor goes into a power saving mode
(Standby/Suspend, Active Off)

Legend for Figure 2-7

1. LED Indicator—Green=Power ON
Amber=Standby/Suspend, Active
Off
2. Control Dial —rotates upward,
downward, and presses inward as a
button

Figure 2-7: Monitor Functions

Note… The recommended initial monitor settings for contrast and brightness are
80% and 65% respectively.

Note… Monitor must be in Normal Mode to adjust contrast and brightness settings.
See Chapter 8, page 146.

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Chapter 2—Using the MultiCare Platinum System
The DSM Computer

13.0 The DSM Computer

The DSM computer has several controls and devices which are used during DSM operation.
The computer consists of a high capacity internal resident disk drive, a 3.5" Floppy Disk
drive, and a DVD/CD drive with archival capability.

Note...… The computer operating system will only recognize diskettes and
DVD/CD disks that are formatted with DOS, Windows 9X/NT/2000.
The DSM Computer Controls
Figure 2-8 shows the controls and indicators on the DSM Computer.

Figure 2-8: DSM Computer (Front View)

Legend for Figure 2-8

1. Power Switch: This push button switch on the front of the computer case turns the MultiCare
Platinum System ON or Off.

2. Reset Switch: This push button switch on the front of the computer case restarts the computer and the
DSM software without removing power from the DSM system. Under normal
conditions, the Reset button is not used, as it may cause loss of unsaved
information.

3. Power Indicator: This LED on the front of the computer case illuminates when the power switch is
ON, indicating that the MultiCare Platinum System is activated (power is
applied to the system).

4. HDD Indicator: This LED on the front of the computer case illuminates when the computer
resident disk is active, such as during storage or retrieval of data.

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The DSM Trackball

14.0 The DSM Trackball

The DSM Trackball (see Figure 2-9, p. 25) is used in place of a mouse to direct movement
when performing computer operations. The Trackball consists of a roller (for movement
control), and left and right side push button controls.
Throughout this manual, use of the Trackball will be stated in point and click terminology.
Using the Trackball Pointer (cursor) to choose an item will be referred to as point. Engaging
the function offered by the right or left push button controls will referred as right click or left
click.

Note… Use of the word “select”, or “click” in this manual implies using
the Trackball to choose an item and left clicking to engage it.

Figure 2-9: The DSM Trackball

Legend for Figure 2-9

1. Trackball This ball moves the cursor around the

screen; functions the same as a mouse.
2. Upper and Lower Left Buttons These buttons perform the same function
as the left button on a mouse.
3. Upper and Lower Right Buttons These buttons perform the same function
as the right button on a mouse.

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Chapter 2—Using the MultiCare Platinum System
The DSM Keyboard

15.0 The DSM Keyboard

The DSM keyboard provides standard alphanumeric keys for entering data. Use of this
keyboard is the same as for any computer system. The DSM program requires that certain
keystrokes be used to perform special functions during operation.

Table 2-4: DSM Keyboard

Key Function
The F1 Key: The F1 Key, at the top left of the keyboard, is used to display
numerical readings of the Contrast (W-value) and Brightness
(L-value) levels when using the Window/Level histogram. When the
histogram is on-screen, press F1 to display these values in the
histogram dialog box. Press F1 again to close the display.
The Numeric Keypad: This Keypad, on the right side of the keyboard, consists of numbered
keys that can be used to enter numbers
(i.e., Patient ID).
The Alternate (Alt) Key: Press Alt + M together to toggle the DSM Main Menu between display
types (icons or labeled buttons). Press Alt + C together to change the
appearance of the information in the Annotation Area (five shades of
background coloring).
The Page Up/Page Down Keys: Press PgUp to scroll upward through a list. Press PgDn to scroll down
through a list.
The Home Key: Press Home to return to the start of a list, or the beginning of a line of
text.
The End Key: Press End to advance to the end of a list, or the end of a line of text.

The Tab Key: Press Tab to advance the cursor to the next available field or menu
selection.

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Chapter 3—Using the Handheld Console
Introduction

Chapter 3—Using the Handheld Console

1.0 Introduction
The Handheld Console function keypad permits the user to scroll through on-screen data
fields, change exposure settings, clear alerts, and initiate an X-ray exposure. This chapter
discusses the features and options available on the console. Figure 3-1 and Table 3-1 on
page 28 describe the front panel.

Figure 3-1: The Handheld Console Front Panel

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Chapter 3—Using the Handheld Console
Introduction

Table 3-1: The Handheld Console Front Panel

Item No. Key or Indicator Information

1 Display Screen Shows system status, alerts, and system settings.
2 Function Keypad Permits user to scroll through on-screen data fields, change exposure
settings, clear alerts, and initiate an X-ray exposure.
The functions are described below.
3 Scroll Keys The Scroll Keys are the up and down arrow buttons. Use the
Scroll Keys to:
Move the focus (highlight) through the data fields.
Adjust the display contrast, when used with the Reset Key.

4 Change Keys The Change Keys are the left and right arrow buttons. Use the
Change Keys to:
Increase or decrease the values presented. Toggle
options on or off.
Cycle through the available choices.
5 Reset Key The Reset Key:
Alone, it acknowledges and clears an alert message.
When used with the Scroll Keys (up and down arrows) it adjusts the
display contrast.
When used with the Change Keys, it gives access to the User Default
and Exposure Default modes.
6 Function Key Service Mode Only.

7 Exposure Indicator The exposure indicator illuminates when the system is generating X-
rays.

8 The X-Ray The X-ray exposure key is used to initiate the X-ray exposure.
Exposure Key

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Chapter 3—Using the Handheld Console
Handheld Console Screens

2.0 Handheld Console Screens

The Handheld Console has three screens: the Run Mode screen, the User Defaults screen,
and the Exposure Defaults screen.

Table 3-2: Handheld Console Panel Display Screens

Run Mode User Defaults Exposure Defaults

Run Mode, the main user screen, is The User Defaults screen allows the user The Exposure Defaults screen allows
displayed after power up. to set DSM Receptor default and date and access to exposure system defaults.
time.

Reminders… To access the User Defaults or Exposure Defaults screens, press and hold
the Reset key on the keypad, then press and release one of the Change
keys (Left/Right Arrows). Use this method to scroll forward and backward
through the three screens.
To select or change values, use the Scroll keys (Up/Down Arrows) to highlight the item,
then use the Change keys to make a selection.

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Operator’s Manual
Chapter 3—Using the Handheld
Console Handheld Console Screens

2.1 The Run Mode Screen

The Run Mode Screen is displayed after power up, and indicates the system is ready for
use. This interface controls the exposure system during clinical procedures and displays
messages about system status.

Figure 3-2: Control Panel in Run Mode

Legend for Figure 3-2

1. Exposure System Displays
2. Message Area
3. Status Area

Note… Some fields are not available for every exposure. The selectable fields
depend on the exposure mode and the installed accessories.

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Chapter 3—Using the Handheld

2.1.1 Exposure System Displays

Table 3-3: Exposure System Choices in the Run Mode

Field Options Comments

kV 22-34 Shows selected kV or displays post-exposure kV.
mAs 3.0 - 400 Shows selected mAs or displays post-exposure mAs in Auto
Modes.
Maximum selectable mAs is dependent upon kV.
MODE Manual Manual: User selects kV and mAs.
Auto-Time Auto-Time: User selects the kV.
DSM Selected Displays the DSM Image Receptor. See Note in Section 2.2.
RECEPTOR
Not Selected
AEC LOCKED Locked When the locked indication is displayed, the MultiCare
Unlocked Platinum uses the exposure technique from the previous scout
image for the new exposure. This option requires stereo
acquisition and Auto-Time Mode.

2.1.2 The Message Area

If the system encounters an alert condition, this area will display the appropriate
message and a numbered code. For a complete list of MultiCare Platinum alert
messages and codes, see.

Note… All alert conditions must be corrected before the message can be
cleared using the Reset key.

2.1.3 The Status Area

The Status Field shows one of the three operating states of the MultiCare Platinum:
• DSM STANDBY: The system is not prepared to make an exposure. The unit
enters this state under normal conditions allowing a brief cool-down period
after an exposure), or when an alert condition exists.
• DSM READY: The MultiCare Platinum is prepared to make an X-ray.
• DSM X-RAY: This status displays whenever the unit is emitting x-rays. Remote
X- ray exposure indication is available if the Remote Control Panel mounting kit
is in use.

Note… All Status Fields are preceded by DSM if the DSM Receptor is selected.

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Chapter 3—Using the Handheld
Console Handheld Console Screens

2.2 The User Defaults Screen

The User Default screen (Figure 3-3) allows the user to set the DSM Receptor default and
the date and time.

Note… The DSM Receptor must be selected to enable communication and control
by the DSM. If the DSM Receptor is not selected, the Generator will reach
Ready Status independent of the DSM and X-rays may be made (used for
calibration and test purposes).

Figure 3-3: The User Defaults Screen

Table 3-4: Choices in the User Defaults Screen

Item Options Comments
DSM RECEPTOR Selected/Not Selected
Date mm/dd/yyyy Sets the system date.
dd.mm.yyyy Highlight the placeholder between fields
(forward slash or a dot) and press a Change
Key to toggle between US and
International date formats.
Time hh:mm AM/PM (12H) Sets the system time.
hh:mm (24H) Highlight the 12H or 24H field and press a
Change Key to toggle between 12-hour and
24-hour formats.

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Chapter 3—Using the Handheld

2.3 The Exposure Defaults Screen

The Exposure Defaults screen has two sections: the upper portion sets the parameter for
the exposure mode, while the lower portion sets the default exposure mode at power up.
To use this screen:
1. Set the parameters for the exposure mode.
2. Choose a default exposure mode for normal procedures.

Figure 3-4: Overview of the Exposure Defaults Screen

Set the parameters for each exposure mode.

Choose which exposure mode for default.

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Operator’s Manual
Chapter 3—Using the Handheld
Console Handheld Console Screens

2.4 Setting Defaults for Each Exposure Mode

2.4.1 Auto-Time Mode

Item Options
kV 22-34

Figure 3-5: Auto-Time Mode Options

2.4.2 Manual Mode

Item Options
kV 22-28 29-34
mAs 3-400 3-350

Figure 3-6: Manual Mode Options

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Chapter 3—Using the Handheld

2.4.3 Default Exposure Mode

Item Options
Default Exposure Mode Manual
Auto-Time

Figure 3-7: Default Exposure Mode

Options

Note… The generator package power supply circuit breaker must be switched
OFF, the back ON to accept defaults. For location see Figure 4-1, p. 37.

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Operator’s Manual
Chapter 3—Using the Handheld
Console Handheld Console Screens

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 Operator’s
Chapter 4—Power Sequences and Checks
Power Up Sequence for the MultiCare Platinum
System

Chapter 4—Power Sequences and Checks

1.0 Power Up Sequence for the MultiCare Platinum System

1.1 Power Up Procedures
Ensure that the Generator Package Power Supply circuit breaker is in the On position. See
Figure 4-1.

Figure 4-1: Generator Package Circuit Breaker

1. Ensure that the DSM Power Supply circuit breaker is in the On position.
2. Ensure the DSM Monitor power switch is On.
3. Switch the DSM computer power button On.

Note… Turning on the DSM computer turns the Multicare Platinum System on.
The system performs its normal start up routine, then automatically launches
the operating system and the DSM program.

Note… It is recommended that the operator complete the Performance Tests

outlined in Chapter 8—Quality Assurance, upon completion of the Power
Up and Start Up procedures.

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Chapter 4—Power Sequences and Checks
Power Up Sequence for the MultiCare Platinum System

1.2 Start Up Procedures

1. When prompted, press Ctrl + Alt + Delete to begin the user Logon sequence.
2. When the Logon dialog box appears, type DSM in the User’s Name field.
3. Then click OK to launch the DSM Program.
If a DICOM Modality Work List is configured, a Modality Work list request is sent
automatically, requesting patient information for all of the current day’s scheduled breast
biopsy procedures. When the request is successful, no message will appear. The resulting
work list is accessible for the Annotation dialog box during Image Acquisition. If a problem
occurs during this request, a warning dialog box will appear on screen, for example:

Note… A user password is not required at logon.

An Authorization Key is required to access DICOM (Digital Imaging and
Communications in Medicine - Standard) services.
DICOM Modality Work List status
Unable to establish Association with Modality Work List Server
OK

When the DSM program is launched, the software checks white field data. In clinical sites
where a DSM system is shared between two or more Host systems, the DSM uses multiple
white field data (provided at installation), which is needed to ensure uniform image quality
for each Host system. If the system detects multiple white field data, the user will be required
to make a Host selection from the dialog box shown in Figure 4-2.

Figure 4-2: Multiple White Field Dialog Box

Select the host configuration for this system:

1. Click the appropriate Host system from the list shown in the dialog box.
2. Use the scroll arrows if necessary to move the Host selection into the window.
3. Click OK to complete the selection.
The DSM Screen appears with the DSM Main Menu displayed on the right side of the screen
(see Figure 4-4, p. 41).

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Chapter 4—Power Sequences and

2.0 Setting Up the Main Menu

The Main Menu (Figure 4-3) is always positioned on the right side of the DSM Screen
and cannot be moved. However, the user may choose to have the menu displayed as
graphics (icons) or as labeled (text) buttons.
To switch the Main Menu between icons or labeled buttons, press the Alt + M key
combination.

MAIN MENU
MAIN MENU
ICONS
BUTTON LABELS

Figure 4-3: The Main

Menus

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Operator’s
Chapter 4—Power Sequences and
Checks Host Verification Procedures

3.0 Host Verification Procedures

The following section describes procedures for verifying proper connections between the
DSM and host system.

Note… When the DSM is turned On, there is a 10 minute wait before X-ray
exposure is possible.

3.1 Host Verification - MultiCare Platinum

Verify the MultiCare Platinum Host Connection with the DSM by performing these steps:
1. Turn power On at the DSM Console, if applicable.
2. Insert the Digital Stereo Aperture into the tubehead slot.
3. Ensure that the Receptor data line reads: DSM.
4. Enter Setup to correct if necessary.

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Chapter 4—Power Sequences and

4.0 The DSM Screen Overview

Use the following legend and illustration (Figure 4-4) to identify the major parts of the DSM
Screen.

Figure 4-4: The DSM Screen

Legend for Figure 4-4

1. Annotation Display Area
2. Main Menu
3. Active Image Display Area
4. Case Study Display Area

4.1 The Main Menu

The Main Menu, which can be displayed as icons or labeled buttons, is used to initiate the
various features of the DSM program, including image acquisition, file management, and
printing.
The Main Menu cannot be moved from its location at the right side of the screen; however,
the user can shrink the menu size by clicking on the minimize button (-) at the top right of
the menu. To bring the menu back to full size, point and left click the maximize button.

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Chapter 4—Power Sequences and
Checks The DSM Screen Overview

4.2 The Annotation Display

This area along the top of the screen displays image information such as the patient’s name
and identification number, the exposure factors used to take the image, the time and date the
image was taken, and any comments or notes the operator may have entered regarding the
exam or patient.
When viewing two single images simultaneously, or when viewing a stereo pair, the
Annotation Area displays separate exposure factors, date/time information, and operator
comments above each of the images. The patient and operator information is always above
the image on the left side of the screen.

4.3 The Active Image Display Area

The Active Image Area consists of two windows for side-by-side examination of single image
views, or a Stereo Pair of images. The Active Image Area is the site where image processing
and coordinate calculations are performed.

4.4 The Case Study Display Area

The Case Study Display Area permits on-screen viewing of an entire case history, and
provides quick recall to the Active Image Area. The Case Study Display Area displays the
case history in the order that the images were taken - starting from the left (first image) and
ending on the right (most recent image).
A case study consists of all the Single images and Stereo Pair images taken of the same
patient on the same day. When the user recalls or acquires an image, the DSM system
routinely checks the disk for additional images associated with that particular case. These
additional images will appear in the Case Study Display Area.

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Chapter 4—Power Sequences and

5.0 The DSM Main Menu

The DSM Main Menu, positioned at the right of the screen, is used to launch the many facets
of the DSM program. The following paragraphs detail the function of each option on the
Main Menu. Refer to listed Chapters for detailed information.

Table 4-1: DSM Main Menu Descriptions

Function Description
Acquire 512: Select this menu option to initiate the single image acquisition sequence in 512
pixel resolution mode. Chapter 7, page 114.
Acquire 1024: Select this menu option to initiate the single image acquisition sequence in 1024
pixel resolution mode. Chapter 7, page 114.
Acquire Stereo 512: Select this menu option to initiate the stereotactic image acquisition sequence in
512 resolution mode. Chapter 7, page 125.
Acquire Stereo 1024: Select this menu option to initiate the stereotactic image acquisition sequence in
1024 resolution mode. Chapter 7, page 125.
Directory List: Select this menu option to launch the Directory List utility. Use this option to
view a list of all the case studies stored on the computer’s resident disk, and
select one for quick recall to the DSM screen. Chapter 6, page 74.

File Manager: Select this menu option to launch the File Manager utility. The File Manager
shows a complete index of all of the images stored on a selected storage device,
and is used to erase, copy, move, recall or print images. Chapter 6, page 80.

Re-Annotate: Select this menu option to begin a sequence that permits the user to modify
previously entered image annotation information. This feature requires that the
user first recall a patient case to the screen using Directory List. Chapter 6, page
103.
Print Screen: Selecting this option permits the user to print the contents of the DSM Screen
exactly as it is seen on the Monitor. Chapter 6, page 97.
Auto-Archive: Select this option to launch the Auto-Archive feature which is a program used to
copy acquired images (cases) onto archival media. Chapter 6, page 106.

Exit Program: Select this option to exit the DSM Program and shut down the computer system.
This will copy any remaining images onto the archival media.

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Operator’s
Chapter 4—Power Sequences and
Checks The Annotation Area

6.0 The Annotation Area

6.1 DICOM Standard Support
The following data fields in the Annotation Display Area match the DICOM standard
requirements:
• Patient DOB
• Patient Sex
• Study Date
• Study Time
• Referring Physician
• Study UID
• Laterality

6.2 The Annotation Area Display

The Annotation Area displays patient case and exposure information in the area above the
Active Images on the DSM screen.
The Table below shows the amount of characters that can be entered in data fields within the
Annotation Area Display.
Table 4-2: Annotation Area
Field Lengths

Field Length
Patient ID 21
Patient Name 21
Operator 21
Comment 32

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Table 4-3 is an overview of each data field in the Annotation Area.

Table 4-3: Annotation Area Data Field Descriptions

Field Description
Patient ID: This field shows the patient identification number, up to 21 characters, that
the user entered during image annotation.
Patient Name: This field shows the patient’s name, up to 21 characters, that the user entered
during image annotation.
Operator: This field identifies the operator taking the exam and can hold up to 21
characters. The user enters this data before taking the exposure.
Comment: This field is supplied for the operator to make notes regarding the patient or the
exam. The comment field, which is filled in before the exposure is taken, holds
up to 32 characters.
kV: This technique field shows the kV used to make the image shown in the Active
Image Area. The data from this field is sent to the DSM from the Host X-ray
system.
Exp(osure): This technique field shows the exposure time (in seconds) used to make the
image shown in the Active Image Area. The data from this field is sent to the
DSM from the Host X-ray system.
mAs: This technique field shows the exposure mAs used to make the image shown in
the Active Image Area. The data from this field is sent to the DSM from the
Host X-ray system.
Date: This field shows the date that the exposure was taken. This data is
provided by the DSM computer system.
Time: This field shows the time that the exposure was taken. This data is
provided by the DSM computer system.
Mode: The Mode field shows the DSM image acquisition mode (512 or 1024
resolution) used to take the exposure. The F label is also displayed here for
images saved with filter enhancements.
View: This field shows the clinical view of the image shown in the Active Image Area.
This information is entered before the image is acquired.
Compression: This field shows the compression thickness of the patient’s breast at the time of
the exam. This data, which is required for stereo exposures only, is entered
during annotation before the exposure is made.

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Operator’s
Chapter 4—Power Sequences and
Checks The Image Display Area

7.0 The Image Display Area

The Image Display Area is the main section of the DSM screen. This area displays newly
acquired images and past cases that have been recalled. The Image Display Area is divided
into two sections:
• The Active Image Display Area
• The Case Study Display Area
The following paragraphs explain each section.

7.1 The Active Image Area

The two windows that make up the Active Image Area are used to examine acquired
images. When an image appears in either the left or right window, or when a Stereo Pair
occupies both windows, the images are considered active. When an image is active—in
either Active Image Window—the user can:
• Perform Image enhancement
• Coordinate calculation of Multiple Targets
• Coordinate calculation of Multiple Passes of the same target
• Re-annotate the image
• Print Screen
Image enhancements, are made via the Image Processing Menu (Chapter 6, page 63). Right-
click in an Active Image to bring the Image Processing drop-down menu to the screen. This
menu offers the following choices:

Table 4-4: Image Processing Menu Choice Descriptions

Field Description
Window / Level: Adjusts image contrast and luminance
Invert: Inverts the video (light turns dark, dark turns light)
Zoom: Enlarges the Image
Mag: Provides small area magnification for finer image scrutiny
Filter: Offers 4 levels of enhancement to sharpen the image, smoothing, levels of
equalization, plus Multi-Contrast Enhancement
Tools: Provides 3 measuring tools
Custom: Provides a Dialog Box containing all the image enhancement tools

The Stereo Target and Multi Pass features are available when a Stereo Pair of images are in
the Active Image Area. When a Stereo Pair is active, the Stereo Targeting window appears.
This window permits the user to calculate the coordinates of up to six targets, or to
calculate the coordinates of up to five additional passes of the same target.

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Chapter 4—Power Sequences and Checks
The Image Display Area

7.2 The Case Study Display Area

The Case Study Display Area, which spans the entire bottom portion of the DSM screen,
displays all of the associated images taken for that case. The Case Study Display Area shows
these related images as thumbnails (up to three rows, 48 images maximum).
Images in the Case Study area can be recalled to the Active Image Area quickly by double-
clicking on the desired thumbnail. Single images are immediately brought to the left Active
Image Window, while stereo images are brought up as a pair and occupy both windows.
Note that stereo images are displayed side-by-side in the Case Study Area (border surrounds
both images).
Any image can be recalled from the case study independently by right-clicking the
Trackball on the desired thumbnail to display the following drop-down menu:

Figure 4-5: Image Recall Drop-down Menu Options

Click either choice to immediately bring the image into the chosen Active Image Window.
This method of image recall works for both single images and Stereo Pair images.

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Operator’s
Chapter 4—Power Sequences and
Checks DSM Shut Down Procedure

8.0 DSM Shut Down Procedure

The following presents an example sequence for exiting the DSM computer and shutting the
system down.
Prepare for System Shut Down:
1. Verify that a DVD/CD disk is in the DVD/CD Disk Drive (Archival Media)
2. Perform any File Manager or Auto-Archive functions as necessary.
3. Click Exit Program from the DSM Main Menu.
4. Click OK at the Exit Program confirmation box.
If the system detects new case studies on the resident disk, the DSM will automatically
perform the Auto-Archive sequence before exiting the program and shutting the computer
off.

9.0 Emergency Stop Switches

Two Emergency Stop switches (see Figure 4-6) are located at the end of the tube arm (one on
each side) within easy reach of the user. These switches lockout Up/Down movement of the
C-arm and table. Up/Down Patient compression is still under the control of the Operator.
Once the Emergency Stop switches are reset, the MultiCare Platinum system returns
to normal operation.

Figure 4-6: Emergency Stop Switches

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 Operator’s
Chapter 5—Preparing the System for Use
Table Accessories

Chapter 5—Preparing the System for Use

1.0 Table Accessories

Compatible table accessories for the MultiCare Platinum include:
• Compression Paddles
• Interchangeable Apertures
• DSM Image Receptor
• DSM Film Scout Holder
• Compatible Biopsy Devices
Installation of each of these devices is discussed next.

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Operator’s
Chapter 5—Preparing the System for
Use Table Accessories

There are five paddles used with the MultiCare Platinum System.

Table 5-1: MultiCare Platinum Compression Paddles

Paddle Description
Compression Used for Stereotactic imaging during the Needle Core Biopsy, Fine
Needle Aspiration, or Wire Localization procedures.

4” Compression Used for Stereotactic imaging during the Needle Core Biopsy, Fine
Needle Aspiration, or Wire Localization procedures.

Scout Used for single film images taken using the DSM Film Scout
Holder.

Perforated Scout Used for single film images taken using the DSM Film Scout
Holder.

T-Shaped Used for Ultrasound procedures.

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Chapter 5—Preparing the System for Use
Table Accessories

1.1 Installing Compression Paddles

To install a Compression Paddle:
1. Lift the locking lever located at the front of the Stage Assembly and move it 180º to
its other side to unlock the Paddle mount.
2. Line up the Compression Paddle dovetailed mount with the jaws near the front edge
of the Stage Assembly and slide the paddle into the jaws from the side.
3. Continue sliding the Paddle in until it clicks firmly into place. Pull back gently to
ensure that it is seated firmly.
4. Re-lock the Paddle mount by moving the locking lever back until the paddle is secure.

Figure 5-1: Installing Compression Paddles

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Operator’s
Chapter 5—Preparing the System for
Use Table Accessories

1.2 Installing the Aperture

Interchangeable Apertures are provided to limit the X-ray field. Aperture selection is
based on the procedure being performed. Use the Digital Stereo Aperture for all
Stereotactic procedures using the DSM. Use the Film Scout Aperture for Scout images
using the DSM Film Scout Holder.
Remove and install either Aperture as described below:
1. To remove, grasp the Aperture faceplate, which contains the Aperture label, and pull out
sideways from the Beam Limiting Device.
2. To install, align the edges of the Aperture with the slots in the Beam Limiting Device
rails and push inward until the Aperture clicks into place.

Figure 5-2: Installing the Aperture

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Chapter 5—Preparing the System for Use
Table Accessories

1.3 Breast Platform Placement

The Breast Platform has 4 selectable positions: 0, 3, 4.5, and 6, which correspond to
distance in centimeters from the C-arm pivot.
Breast platform placement is based on compression thickness. A thinner compressed breast
results in less image shift. A thicker compressed breast results in more image shift. Greater
compression thickness results in wider white bands on outer edges of images.
Proper placement of the breast platform is essential. Table 5-2 for proper placement.

Table 5-2: Breast Platform Position/Compression

Thickness

Tray Position Compression Thickness

3.0 0 - 4.0 cm
4.5 4.0 - 5.5 cm
6.0 >5.5 cm

Note… The 0 cm position is not used clinically. It is only for service use.
To adjust the Breast Platform position, perform the following steps:
1. Press down on one of the two silver levers, one is located on each of the plates
that attach the Breast Platform to the Compression Arm.
2. With the lever depressed, move the Breast Platform to the required position, as indicated
by the pointers on each side of the Compression Arm.

Figure 5-3: Breast Platform Adjustment

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Operator’s
Chapter 5—Preparing the System for
Use Table Accessories

1.4 Mounting the DSM Image Receptor

Mount the DSM Image Receptor onto the Tube Arm to acquire digital Scout or Stereotactic
images. To install the DSM Image Receptor:
1. Turned power Off at the DSM Console.
2. Pull out the spring-loaded locking pin located on the image receptor mount on the
Tube Arm, opposite the X-ray tube end.
3. Rotate the locking pin 90° and release it into its retainer so it parks in the
extended position.

Caution: Clear cables from all equipment so no damage will occur.

4. Line up the DSM mounting bracket with the receptor mount on the Tube Arm and slide
the DSM Image Receptor onto the Tube Arm until it is approximately centered in the
Tube Arm mount.
5. Pull out the locking pin again, rotate it 90° and release it from the parked position.
6. Slowly move the DSM Image Receptor back and forth in the mount until the locking pin
seats completely in the lateral position of the Image Receptor.
7. Attach the 50-pin connector of the Image Receptor Data cable to the DSM DATA
receptacle under the Tube Arm, and the 25-pin cable connector of the Image
Receptor Power cable to the DSM POWER receptacle.
8. Attach the 9-pin AEC cable to connector adjacent to DSM Data and Power Connectors.
9. Verify that the Run Mode screen of the Handheld Console shows DSM RECEPTOR. If
not, enter the User Defaults screen (see “Handheld Console Screens” on page 29), and
switch to DSM RECEPTOR: SELECTED.

Figure 5-4: Mounting the DSM Image Receptor

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Chapter 5—Preparing the System for Use
Table Accessories

1.5 Mounting the DSM Film Scout Holder

The DSM Film Scout Holder clips to the front (tube) side of the DSM Image Receptor to
provide a support for a film cassette used to obtain a full field scout film with the DSM
Image Receptor installed. The DSM Film Scout Holder may be left in place, as it does not
obstruct the image path to the DSM until a film cassette is loaded.
To install the DSM Film Scout Holder:
1. With the DSM mounted on the MultiCare Platinum Tube Arm, move the Breast Platform
to either the 3 cm, 4.5 cm, or 6 cm position. Note that the 0 cm position is not used
clinically with the DSM.
2. Place the DSM Film Scout Holder over the front of the DSM Image Receptor. Mounting
tabs on the inside surface of the DSM Film Scout Holder snap into depressions around
the edges of the DSM Image Receptor. Make sure that all four nubs seat into their
respective holes for proper placement.
3. Install the Film Scout Aperture and the Scout Paddle.
4. Slide a cassette into the holder from the side, keeping the tube side of the
cassette toward the X-ray tube, and making sure that the cassette is firmly seated
against the lower stop in the holder.

Figure 5-5: DSM Film Scout Holder Installation

Note… DSM exposures are not enabled until the DSM Acquire Image process is
activated and WAITING FOR X-RAY TO BEGIN appears on the DSM
screen. To enable an exposure for the film, complete the Acquire Image
selection process on the DSM. Annotate the resulting digital image to
indicate it is a film scout shot. Later, erase this image without archiving, as it
was obtained through the film cassette and will not be needed.

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Operator’s
Chapter 5—Preparing the System for
Use Installing Compatible Biopsy
Devices

2.0 Installing Compatible Biopsy Devices

Biopsy accessories compatible with the MultiCare Platinum include the following:
• Biopsy Device Holders
• Rear Needle Guide Mount
• Vacuum Assisted Biopsy Devices
These accessories attach to and interact with the MultiCare Platinum Stage, and each
follow the same zeroing procedure. Refer to the documentation provided with the
compatible accessory for operating instructions.

Note… There are a variety of available biopsy devices. Please call Hologic to
verify their compatibly with the MultiCare Platinum system.

Note… Please refer to the biopsy device manufacturer’s operator’s manual for
specific directions for mounting the devices.

2.1 Installing the Biopsy Device Holder

Holders are specific to the type of biopsy device being used. Each holder is labeled with the
following information to help the user determine which biopsy device it holds:
• Manufacturer’s name
• Biopsy device model number
The holder is installed first onto the MultiCare Platinum Stage, then the biopsy device is
installed onto the holder for Needle Core Biopsy procedures.
To mount the holder to the Stage perform the following steps:
1. Position the holder over the Stage platform, with its open end facing the X-ray tube.
Align the guide holes on the bottom of the holder with the pins on the Stage
platform.
2. Lower the holder onto the mounting screw so that it rests in the threaded center hole.
3. Secure the holder to the Stage by turning the large thumbwheel below the
Stage platform.

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Chapter 5—Preparing the System for Use
Installing Compatible Biopsy Devices

Figure 5-6: Installing the Biopsy Holder

Note… Always cock the biopsy device before installing the device into the
holder on the stage.
To mount the biopsy device into the holder:
1. Turn the Z-control knob to move the holder completely back (toward the X-ray tube).
2. Loosen the thumbscrew on the side of the holder.
3. Install a needle guide into the front Needle Guide Mount.
4. Move the Needle Guide Mount completely forward (toward the Compression Paddle).

Caution: Always practice sterile techniques when handling needle guides.

5. Place the biopsy device SAFETY to ON.

6. Slide the device completely into the holder from the rear (open end), until it
stops. Ensure that the needle goes through the hole in the sterile needle guide.

Note… If necessary, slide the Needle Guide Mount toward the X-ray tube so
that the tip of the needle goes through the needle guide hole.
7. Secure the device in place by tightening the thumbscrew on the side of the holder.

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2.2 Installing the Rear Needle Guide Mount

Install the Rear Needle Guide Mount to the Stage platform when performing Fine Needle
Aspiration or Wire Localization procedures. Also use the Rear Needle Guide Mount during
the Quality Assurance verification procedure to confirm the accuracy of the system.
1. Orient the Needle Guide Mount over the Stage platform so that the Needle Guide
Mount is toward the Compression Paddle.
2. Align the guide holes on the bottom of the Needle Guide Mount with the pins on the
Stage platform.
3. Lower the Needle Guide Mount onto the mounting screw so that it rests in the threaded
center hole. Secure by turning the large thumbwheel below the Stage platform.

Figure 5-7: Installing the Rear Needle Guide Mount

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2.3 Installing the Front and Rear Needle Guides

Install a sterile open or closed slot Needle Guide to the Front Needle Guide mount, and an
additional sterile open or closed slot Needle Guide to the Rear Needle Guide mount for Fine
Needle Aspiration and Wire Localization. A sterile slot Guide is used for Needle Core
Biopsy. Non-sterile closed slot Needle Guides are used during the Quality Assurance
verification procedure.
To install Needle Guides perform the following steps:
1. Orient the Needle Guide so that its raised edge faces the Breast Platform.
2. Place the keyhole shaped opening in the Guide over the post in the Needle Guide
Mount and press down until the Guide snaps into place.

Note… Please support the Guide post while adjusting the guides.

Caution: Always practice sterile techniques when handling needle guides during
patient procedures.

Figure 5-8: The Front and Rear Needle Guides

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2.4 Positioning The Table and C-arm

Table positioning and breast compression controls are located on a movable Table Control
Panel at the base of the C-arm pivot. The Control Panel can be rotated after pulling a latch
underneath it to keep the control accessible when angling the C-arm, and to move the
controls out of the way during clinical use.

Safety Keyswitch
A key operated, two-position switch, with a lighted indicator, prevents inadvertent control
actuation during a clinical procedure. With the Keyswitch in the ON position, the indicator
illuminates, and all Control Panel Operations: Table Up/Down, C-arm Up/Down, Rotation
Release, C-arm Centering Release, Compression Up/Down, and Light Up/Down, are
functional. When the Keyswitch is moved to the LOCKOUT position, only the Light Up/
Down control is functional.

Warning: To avoid patient injury, after positioning the patient and applying
compression, place the Keyswitch in the LOCKOUT position to
prevent inadvertent C-arm movement during procedures.

Adjusting Table Height

Adjust table height with use of a TABLE UP push button or a TABLE DOWN push button
on the Table Control Panel. The Table surface is generally positioned so that during the
procedure, the work area is at a convenient height.
Lower the Table to its minimum height using the TABLE DOWN button. This allows the
patient to easily climb onto the Table.
To achieve minimum height, raise the C-arm to within 1 inch of the underside of the Table.
When the Table height controls are used, the C-arm moves in unison with the Table
surface. The Table stops automatically at upper and lower limits.

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Controlling C-arm Height

Control C-arm height with use of C-ARM UP and C-ARM DOWN push buttons on the table
Control Panel. When these controls are used, the C-arm moves independently of the Table
surface. The C-arm stops automatically at its upper and lower limits. C-arm height is
generally adjusted to place the region of interest vertically within the Compression Paddle
biopsy window.

Note… This is also available on foot controls.

Setting the C-arm Angle

Set the C-arm angle by manually rotating the C-arm while pressing one of the ROTATION
RELEASE push buttons. With the ROTATION RELEASE push button pressed, the Tube Arm
portion of the C-arm moves in unison with the Compression Arm portion. With the
ROTATION RELEASE push button released, the Tube Arm moves independently of the
Compression Arm, and only to the +15° and -15° positions for stereotactic imaging.
Generally, the C-arm is angled for appropriate access to the area of interest.

Adjusting the C-arm Position

Adjust the C-arm lateral position (across the centerline axis of the table) and longitudinal
position (parallel to the centerline of the table) by manually moving the C-arm while
pressing and holding down one of the C-ARM CENTERING push buttons on the Table
Control Panel.
The two identical push buttons are located on the panel so that they can be pressed easily
while simultaneously grasping the handles at the sides of the control panel to position the C-
arm. The C-arm can be pushed in or pulled out, and shifted to the right or left, as shown in
Figure 5-9, to position the breast platform and compression Paddle relative to the patient.

Figure 5-9: C-arm Position Adjustment

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Adjusting the Lights

Two work lights located below the Table surface illuminate the work area. The lights are
turned on, and their intensity controlled, by LIGHT UP and LIGHT DOWN push buttons
on the Table Control Panel.
Pressing the LIGHT UP push button slowly increases light intensity on both lamps. Pressing
the LIGHT DOWN push button slowly decreases light intensity until both lamps are off. Each
lamp can be freely positioned to direct its output toward the work area.

Compression Control
Breast Compression is accomplished using a force-limited system that provides motorized
pre-compression force and manually applied full compression.
Apply motorized pre-compression force by pressing the COMPRESSION DOWN push
button on the Table Control Panel (or operating the appropriate pedal on the
accessory footswitch). Pressing the COMPRESSION DOWN push button causes the
Compression Paddle to move toward the Breast Platform.
Pressing COMPRESSION DOWN also actuates an electrical one-way clutch that keeps
compression force constant after the COMPRESSION DOWN push button is released. There
is a COMPRESSION UP push button that moves the Compression Paddle away from the
Breast Platform. It also releases the one-way clutch. Once compression force reaches its
maximum motorized pre-compression limit, the Compression Paddle stops. Apply additional
force by using the handwheels. Manually applied compression force is also maintained by
the one-way clutch. Press the COMPRESSION DOWN push button before applying
manual compression to set the clutch. Force is not released until COMPRESSION UP is
pressed.

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Chapter 6—DSM Operations

1.0 Using The Image Processing Menu

The DSM program offers an Image Processing menu that permits the user to:
• Enhance Images: features to help define structures in the image
• Visualize Areas: tools to Zoom-In or magnify suspicious areas
• Make Measurements: aids used to measure size and distance
The Image Processing menu can be accessed whenever an image is in either Active Image
Window (right or left side). Use the trackball to move the pointer onto the left or right image,
then right-click to bring the Tools sub-menu onto the image:

Figure 6-1: Image Processing Menu

Select an option from the sub-menu by pointing to the desired item (choice becomes
highlighted), then left-click to select. The option used will only affect the selected image (the
image that the pointer was in when the Image Processing menu was accessed).

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Using The Image Processing
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1.1 The Window/Level Option

The Window/Level Option - also called the Window/Level histogram - allows adjustments
to be made to the contrast and brightness of the selected image.
To use the Window/Level:
1. Select the image to be enhanced.
2. Move the pointer over the image to be enhanced (left or right Active Image Area).
3. Right-click to bring the Image Processing menu onto the Image.
4. Select the Window/Level Option.
5. Point on the Window/Level item in the sub-menu.
6. Click to bring the Window/Level window to the screen.

Figure 6-2: Window/Level Option

To make Enhancements:
• Roll the trackball up and down to change the image contrast.
• Roll the trackball left and right change the image brightness.
• Press Spacebar to invert and revert the image.

Note… Arrow keys allow for fine adjustments.

To end Window/Level Enhancements:

• Right-click to bring the image back to its original state.
• Click to close the Window/Level window and retain the enhancements.
The image can be saved with the contrast and brightness changes by clicking Save Image
from the Image Processing menu. Doing this will update the saved display parameters for
the image so that it is displayed with the changes the next time it is recalled.

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1.2 The Invert Option

The Invert option reverses the light and dark structures in the image. This feature may
help with tissue and structure discernment.
To select the image to be enhanced:
1. Move the pointer over the image to be enhanced (left or right Active Image Area).
2. Right-click to bring the Image Processing menu onto the Image.
Select the Invert Option:
1. Point on the Invert item in the sub-menu.
2. Click to invert the image on the
screen. Revert the image:
1. Right click the image processing menu.
2. Click invert.

Figure 6-3: Invert Option

The image can be saved with the inverted enhancements by clicking Save Image from the
Image Processing menu. Doing this updates the saved display parameters for the image so
that it is displayed with the changes the next time it is recalled.

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1.3 The Zoom-In Option

The Zoom-In option enlarges the image in the Active Image Window to full screen size. To
use the Zoom-In option:
Select the image to be viewed:
1. Move the pointer over the image to be enlarged (left or right Active Image Area).
2. Right-click to bring the Image Processing menu onto the Image.
Select the Zoom-In Option:
1. Point on the Zoom-In item in the sub-menu.
2. Click to enlarge the image to full-screen.

Figure 6-4: Zoom-In Option

When the image is enlarged using Zoom, the user can right-click in the full-screen image to
access the Image Processing sub-menu. In full-screen viewing mode, all of the Image
Processing options, except Mag, can be used.
Revert the Image:
1. Right-click in the image to access the Image Processing menu.
2. Point on the Zoom-Out item in the sub-menu.
3. Left click to reduce the image to normal viewing size.

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1.4 The Mag On Option

The Mag On Option displays a magnification window or box on the selected image. The
Mag window size is adjustable and allows the user to scrutinize an area of interest (2x
magnification ratio) without enlarging the entire image. To use the Mag on option:

Note… The Mag On option can be used on both images for viewing and targeting.
Select the image to view:
1. Move the pointer over the image to magnify (left or right Active Image Area).
2. Right-click to bring the Image Processing menu onto the Image.
Select the MAG On Option:
1. Point on the Mag On item in the sub-menu.
2. Left click to bring the magnification window into the image.

Figure 6-5: Mag On Option

3. Once the magnification window is over the selected image, use the trackball to move it
throughout the entire window. The DSM permits the window to overlap the edges of
the image, but does not allow the user to move the magnification window between the
left and right images.
4. Right click the trackball to scroll through the five window sizes (increase or
decrease window size).
5. Left click the trackball to “paste” the magnification window onto the image.

Note… To change image brightness while the Mag box is active, use the “+” and
“- ” keys on the keyboard number pad.

Note… Left-click the trackball to target or remove the Mag Option.

Remove the Magnification Window:
1. Move the pointer over the image with the magnification window.
2. Right-click to bring the Image Processing menu onto the Image.
3. Click the Mag Off item to remove the window.

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1.5 The Filter Option

The Filter option from the Image Processing menu offers 4 levels of image sharpening,
optional smoothing, and 2 levels of equalization.
The Sharpen options enhance the image by increasing the contrast variances in the image,
making object edge definition more pronounced. Each incremental level provides an
increased degree of image sharpening. With the Add Smoothing option, these enhanced
edges are then smoothed (softened) to generate uniform transitions from black to white,
or white to black.
The Equalize options even-out the grayscale in the image, such that image details are still
visible at high contrast levels. The user may select emphasis of low or high frequency
enhancement.
The Multi-Contrast option increases image contrast and adds a slight amount of sharpening
to the image.
1. Select the image to be filtered.
2. Move the pointer over the image to be enhanced (left or right Active Image Area).
3. Right-click to bring the Image Processing menu onto the Image.
4. Select the Filter Option.
5. Click the Filter item to access the filter options.
6. Click to the desired Sharpen level (Sharpen 1 = least, Sharpen 4 = most).
7. Add Smoothing, or Equalize Level (Lows, Highs).
8. Left click to apply the selected filtration method.
9. Repeat this step to remove or change filter options.
10. Save Filtered Image.
11. Right click in the filtered image.
12. Click the Save Image item from the Image Processing menu.

Note...… When checked, Add Smoothing is only applied when a Sharpen filter is in
effect. A Sharpen filter and an Equalize filter may be applied to the same
image.

Figure 6-6: Filter Option

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When an image has been enhanced using Filter, the letter F appears in the Mode line of the
Annotation Area to indicate that the image has been filtered. To determine which filter
options were applied to the image, open the Image Processing menu, then click the Filter
item. A check mark appears next to the filter options used to enhance the image.
The user may elect to view the filtered image in its original state (non-filtered). To do this,
open the Image Processing sub-menu, click the Filter item, then click Original Image.

1.6 The Tools Option

The Tools option in the Image Processing sub-menu provides measurement tools which
permit the user to determine object size, or distance between objects. The measurement
tools available are:
• Ruler
• Target
• Calipers

Note...… The measurement for the Ruler and Target Tools are in the plane
perpendicular to the X-ray beam path. Due to beam spread and the
resulting geometric magnification factor, the actual distance will vary from
the distance indicated by each graduation (ruler) or ring (target), depending
on the depth of the object being estimated. The tools are calibrated for a
distance of 1 mm at the plane of the rotation point of the C-arm.

Figure 6-7: Tools Option

The Ruler and Target tools are used for estimating the approximate size of an area of
interest in the image. Choose the Ruler to bring a ruler image, with graduation marks, into
the selected image. The ruler is calibrated for approximately 1 mm per graduation at the
plane of the C-arm rotation. Choose the Target to bring a bulls-eye of concentric circles
into the selected image. The target is calibrated for approximately 1 mm between rings at
the plane of the C-arm rotation.
The Calipers tool is used to estimate distance between two user-selected points in the Image.
The user draws a line on the image, then the DSM calculates the approximate distance
between the points. The estimated length of the line is displayed on the image.

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1.6.1 Select Ruler Tool

1. Right click in the image requiring measurement to access the Image Processing
menu.
2. Click Tools, then click Ruler (see Figure 6-8).
3. Move the trackball to move Ruler within the image.
4. Right click to rotate the Ruler Tool (change orientation).
5. Click to clear the Ruler Tool from the image.

Figure 6-8: The Ruler Tool

1.6.2 Select the Target Tool

1. Right click in the image requiring measurement to access the Image Processing
menu.
2. Click Tools, then click Target (Figure 6-9, p. 70).
3. Move the trackball to move Target within the image.
4. Right click to switch the ring color between black and white.
5. Left click to clear the Target Tool from the image.

Figure 6-9: The Target Tool

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1.6.3 Select the Calipers Tool

1. Right click in the image requiring measurement to access the Image Processing
menu.
2. Click Tools, then click Calipers (see Figure 6-10).
3. Move the trackball to position the 1st endpoint, then left click to anchor it.
4. Right click to switch to the line color between black, white, or variable with
the underlying image data.
5. Move the trackball to position the 2nd endpoint, then left click to anchor it.
6. Right click to clear the Calipers Tool from the image.

Figure 6-10: The Calipers Tool

Note… The DSM pastes a tag with the approximate measurement next to the 2nd
endpoint. The user can make many Caliper measurements within the
same image. The DSM will label each line with the approximate
measurement.

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Using The Image Processing

1.7 The Custom Option

The Custom option in the Image Processing menu provides access to all of the Image
Processing Options from a dialog box (Figure 6-11).

Figure 6-11: The Custom Option

Filter Both Images—If Filter Both Images is checked, the currently selected filter is applied
to both the Left and Right image. If Filter Both Images is not checked, the filter is applied to the
selected image only (either the Left or Right image).
Apply to Subsequent checkbox—Allows the user to apply the current filter to subsequent
images or newly acquired images.
If this box is checked, the last filter is applied to subsequent images. When a new image is
acquired, the filter is not applied until after the image has been saved (after the user is
done setting Window/Level). Once the image has been saved, if the filter has been applied,
the image is redisplayed with the new filter. The filter values are saved with the image.

Note… This option has no effect on ScoutMarc images. ScoutMarc images retain
the originally set filter.
Save—Saves the enhanced images.

Done—Reverts back to the original image.

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2.0 Saving The Image

The image can be saved with any of the enhancements made previously using the Save
Image choice from the Image Processing menu. To save the image with the enhancements,
perform these steps:

2.1 Make image enhancements:

• Make Contrast / Luminance changes.
• Invert the image, if needed.
• Select filtration enhancements, if needed.

Note… The only enhancements that can be saved with an image are
Window/ Level, Invert, and Filter.

2.2 Save the image:

1. Right click in the image to be saved to access the Image Processing menu.
2. Click the Save Image item. The image is saved with all the enhancement changes. If
the image was previously archived, the following warning appears:

Figure 6-12: Archived Image Warning

3. To cancel the save function, click No. The image is not saved with the enhancements.
4. To continue the save function, click Yes. The DSM will replace the previous version
with the enhanced version. The original enhancement information of the previously
archived image will also be lost.

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The Directory List Window

3.0 The Directory List Window

The Directory List permits the user to recall a Case Study to the Active Image Area from a
list of all the case studies stored on the DSM Computer’s internal resident disk drive.
Several search options are provided in the Directory List to aid in locating specific case
studies.
To open the Directory List Window, click the Directory List button on the DSM Main Menu.
The Directory List Window (see Figure 6-13) which appears on-screen is divided into three
sections:
• The Case Study List
• The Image List
• The Parameter (Search) Menu

Figure 6-13: The Directory List Window

The following paragraphs describe the three elements of the Directory List Window and
present methods for locating specific case studies and images.

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4.0 The Case Study List

The Case Study List appears on the left side of the Directory List Window. The list consists
of all the Case Studies stored on the DSM Computer’s resident disk. Each Case Study lists
four annotation parameters. These parameters correspond to the four column headings at
the top of the Case Study List:
• Column 1: Patient ID
• Column 2: Patient Name
• Column 3: Operator
• Column 4: Date

Figure 6-14: The Case Study List

4.1 Quick Sort

The Patient ID, Patient Name, Operator and Date column headings also can be clicked on to
serve as Quick Sort buttons to arrange the list by annotation parameter. The following
table describes each of the Case Study List’s annotation parameter attachments, and the
results of sorting by each parameter. Repeating the sort will rearrange the list in the
reverse order.

Table 6-1: Case Study List Column Headings

Headings/
Description
Buttons
Patient ID Lists the Patient ID for each Case Study on the resident disk. Quick Sort rearranges the
Case Study List in alphanumeric order by the patient’s identification number.

Patient Name Lists the Patient Name for each Case Study on the resident disk. Quick Sort rearranges the
Case Study List in alphabetical order by the patient’s name.
Operator Lists the Operator that acquired the image for each Case Study on the resident disk. Quick
Sort rearranges the Case Study List in alphanumeric order by the operator’s identification
code.
Date Lists the acquisition date for each Case Study on the resident disk. Quick Sort rearranges
the Case Study List in chronological or reverse chronological order by the date.

Note… When the Directory List is first opened, the case studies are listed in
chronological order by date. The first Case study is always
highlighted.

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The Image List

5.0 The Image List

The Image List (see Figure 6-15) is displayed on the right side of the Directory List Window.
This list shows all of the single images and stereo image pairs that are saved as part a Case
Study (the highlighted case in the Case Study List to the left). Each image or image pair
lists three annotation parameters. The parameters correspond to the column headings at
the top of the Image File List:
• Column 1: View
• Column 2: Mode
• Column 3: Comment
Table 6-2 explains each of the Image List’s annotation parameter attachments.

Table 6-2: The Image List’s Annotation Parameters

Annotation
Description
Parameters
View The View was selected by the operator during the annotation procedure when the image
was acquired. This column shows the type of image taken (Scout, Stereo, Pre-Fire, etc.).

Mode The Mode is chosen by the operator at the beginning of the Acquire sequence. This column
indicates the resolution mode for the image (512 or 1024).
Comment This column shows any comments that the operator may have entered concerning the
procedure during annotation.

Figure 6-15: The Image List

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6.0 The Parameter (Search) Menu—Directory List Window

The Parameter Menu or Search Menu (see Figure 6-16) is displayed below the Image List on
the right side of the Directory List Window. This menu provides four search options which
are used to help narrow a search for a specific Case Study. The four search options
correspond to the four Quick Sort column headings in the Case Study List:
• By Patient ID
• By Patient Name
• By Date
• By Operator
When these search methods are used, only those image files that match the search criteria
entered appear on the Case Study List.
To search for an exact match, select the option, type in a name or ID and click Search.
There is an option to search on the first few characters. Type in the first few characters
and click Search. Software will locate everything that matches the beginning characters.
The Search option is not case sensitive.

Figure 6-16: The Parameter (Search) Menu

6.1 The Search Button

Click Search after selecting a search option and entering the search criteria. The DSM
program will search the entire resident disk for Case Studies that contain only the entered
criteria. Case studies that match the criteria are displayed in the Case Study List.

6.2 The List All Button

Click List All to refresh the Case Study List after using a search function. The Directory List
redisplays all of the Case Studies on the resident disk.

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Operations Recalling A

7.0 Recalling A Case Study

When a specific Case Study has been located, the user can recall it to the main DSM screen.
When an image is recalled, the user can perform all of the DSM functions typically available
(i.e., image enhancement, targeting, etc.). There are two methods of recall (see Table 6-3).

Table 6-3: Methods of Recall

Method Result
Recall from the Case Study List By default the first (oldest) image will display in the Active Image
Area.
Recall from the Image List The selected image (or stereo pair) displays in the Active Image
Window.

All the associated images in the Case always appear as thumbnails in the Case Study Display
Area (see Figure 6-17).
The recall method determines which image or image pair displays in the Active Image
Window.

Figure 6-17: Thumbnails in the Case Study Display Area

7.1 Initiate Search Options

1. From the Main Menu, click Directory List.
2. Click any search option (Patient ID, Patient Name, Operator, Date).
3. Type the appropriate search criteria in the adjacent field.
4. Click Search to initiate the search.
The DSM searches the entire resident disk for Case studies containing the entered search
criteria. When the search is complete, the Case Study List shows only the Case Studies that
contain the search criteria.
If the search does not find any Case studies that match the criteria, the following appears:

Figure 6-18: No Match Found Dialog Box

If this message appears, click OK, re-enter the search criteria, then initiate another search. If
the search finds more Case Studies than can be displayed in the Case study Window, a
scroll bar appears on the right side of the list.
To view all the Case Studies, click the scroll arrows at the top and bottom of the scroll bar. To
Quick Sort the list, click the heading to use for the sort (see “Quick Sort” on page 75).

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7.2 Recall a Case Study—Default

1. Scroll the list to locate desired Case study.
2. Double-click a Case Study to recall that case to the DSM screen.
The selected patient case displays on the screen. The first (oldest) image is in the Left Active
Image Window (default), and all the associated images appear as thumbnails in the case
study area

7.3 Recall a Case Study—Choose Image

1. Scroll the list to locate desired Case study.
2. Highlight the desired Case Study.
3. Double-click the desired Image in the Image List to recall the case to the DSM screen.
The selected patient case displays on the screen. The image chosen is in the Left Active
Image Window (or both windows if it is a stereo pair), and all the associated images appear
as thumbnails in the case study area.
When an image is recalled, the Directory List Window is automatically closed.
4. To close the Directory List Window without recalling a Case Study, click Close at the
bottom of the Directory List Window.

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The File Manager Window

8.0 The File Manager Window

This feature permits the operator to locate image files from any available storage device and
perform these standard file management functions:

Table 6-4: File Management Functions

Function Result
Erase Deletes selected image files from a local source device
Copy Duplicates image files from a source device to a destination device
Move Copies files to a destination device, then erases them from the local source

These functions allow the user to:

• Free disk space
• Transfer image files between storage devices
• Print selected images to a film laser printer
• Recall an image from the local Archive Disk to the Main DSM Screen
To open File Manager, click the File Manager button on the DSM Main Menu.
The File Manager Window (see Figure 6-19) is made up of these four elements:
• The Image List
• The Parameter (Search) Menu
• The Function Menu
• The Operation Menu
The following Sections describe the elements of the File Manager Window and present
example sequences for performing file management functions.

Figure 6-19: The File Manager Window

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9.0 The Image List

The Image List is the top portion of the File Manager Window, and contains a listing of all
the images on the selected storage device. Each image in the window lists seven annotation
parameters that are described in the table below. Columns one through four may be used
for a Quick Sort by clicking their headings.

Table 6-5: Images List Annotation Parameters

Column
Parameter Description
Number
1 Patient ID This column shows the Patient ID for each image stored on the selected storage
(source) device. The Patient ID is entered by the operator during annotation
before the image is acquired.
2 Patient The data in this column shows the name of the patient for each image stored on
Name the selected storage (source) device. The Patient Name is entered by the operator
during annotation before the image is acquired.
3 Operator This column shows the operator’s identification code that was entered during
annotation before the image was acquired. Typically the Operator ID is the
user’s initials.
4 Date All acquired images are stored with the date of the procedure. The date is
assigned to the image automatically by the DSM Computer when the image is
saved. When the File Manager is first opened, the images are listed in
chronological order by date.
5 View The View was selected by the operator during annotation before the image was
acquired. This column shows the type of image taken (Scout, Stereo, Pre-Fire,
etc.).
6 Mode The resolution Mode (512 or 1024) used to acquire the image is shown in this
column.
7 Comment The Comment data is keyed in during annotation, before the image is acquired.
This column shows the exam comments entered by the user.

Note… The View, Mode and Comment columns do not offer the Quick Sort
function.

10.0 Parameter (Search) Menu—File Manager Window

The Parameter Menu - or Search Menu (see Figure 6-16, p. 77), is displayed below the
Image List on the left side of the File Manager Window. See “The Parameter (Search) Menu
— Directory List Window” on page 77 for details on search operations.

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11.0 The Function Menu

The Function Menu (see Figure 6-20) is centered in the File Manager Window below the
Image List. The operator uses this menu to setup how File Manager operations (erase, copy,
etc.) functions. The Function Menu is comprised of:
• Number of Images Selected display
• View Images selection box
• Source Device select menu
• Destination Device select menu
• Select All button
• Unselect All button
• DICOM Query button
The user must set these functions before initiating a File Manager operation.

Figure 6-20: The Function Menu

Note… It is highly recommended to select View Images, especially when erasing

clinical Images. The File Manager does not have a recovery - undo -
feature once the operation is performed.

Note… The Source Device and the Destination Device cannot be the same.

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Table 6-6: Function Menu Options

Menu Item Description
Number of Images Selected This display field shows the total number of images highlighted in the
Image List Window. The count displayed changes as images are selected
or deselected.
View Images Select this option to confirm the File Manager operation for each
highlighted image.
Un-select this option to perform the File Manager operation without
confirmation.
When View Images is checked, the program will recall highlighted
images to the DSM screen, then prompt the user to confirm the File
Manager operation
This process is repeated for each selected or highlighted image.
When View Images is not checked, the program will immediately prompt
the user to confirm the File Manager operation.
An affirmative response initiates the File Manager operation without
recalling images, and without further confirmation.
Source Device Select The Source Device is the local file storage device from which File
Manager operations are performed. Use this drop-down menu to choose
between the following Source Devices:
- Internal resident disk drive
- Archive Disk (DVD/CD drive)
- Floppy Disk
The File Manager displays all of the Images stored on the selected source disk.
Destination Device Select The Destination Device is the storage device that receives the images
when the Copy or Move functions are performed. This selection is not
required when erasing, printing, or recalling image files. Use this drop-
down menu to choose between the following Destination Devices:
- Internal resident disk drive
- Archive Disk (DVD/CD drive)
- Floppy Disk
- DICOM Storage Server Name (0-3 entries)

Select All Button Click this button to select all the image files on the source device. This
function highlights every image file shown in the Image File List.

Unselect All Button Click this button to unselect all the image files on the source device.
This function removes the highlight from the selected image files shown
in the Image File List.
DICOM Query Button Click this button to find and retrieve Case Studies that were stored using
File Manager Copy to a DICOM Storage Server.

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12.0 DICOM Query Options

Two check-boxes are available in the Set Preferences dialog box (Figure 6-20, p. 81).
• When selected, the first check-box allows partial entries for Patient IDs when
making DICOM queries.
• When selected, the second check-box allows partial entries for Patient Names when
making DICOM queries.
For example, if 123 is entered for Patient ID the Query returns all IDs that start with
123. If the boxes are not checked, the query only returns an exact match.

Note… Support for wildcard queries is optional in the DICOM standard, therefore
some sites may not support partial entries for DICOM query. In this case, the
check-boxes must be unchecked (exact match only), or the queries will
not work at all.
Query search may behave differently from one implementation to the other
depending on the local system. (i.e. no wild card matching or capitalizing
of names etc.)
Recommended Settings
For DSM software versions 3.0.1 and earlier:
• Allow partial IDs in DICOM Queries:NOT Checked.
• Allow partial names in DICOM Queries:NOT Checked.
DO NOT CHECK EITHER BOX. Wildcard Queries are NOT supported in DSM software
versions 3.0.1 and earlier. Leave both boxes un-checked, or problems will occur.
For DSM software versions 3.1.0 and later:
• Allow partial IDs in DICOM Queries:NOT Checked.
• Allow partial names in DICOM Queries:Site Preference. (Can be checked if the Query
Server supports wildcard queries).

Note… Hologic recommends using an exact match for Patient IDs. In most
installations, a wildcard search by Patient ID will produce too
many matches to be useful.

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12.1 Image Display Options

Two check-boxes are available in the Set Preferences dialog box (Figure 6-21).
• The first check-box allows the operator to choose their preferred method for displaying a
1024 X 1024 image in a 512 X 512 window. When checked, 2 by 2 averaging is used
(software binning). When not checked, sub-sampling is used (displays every other line
and pixel).
This setting also affects how 1024 images are printed. If 2 by 2 averaging has been selected
and the DSM File Manager is used to print a 1024 image and Low (512) is selected in the
Print Resolution drop down menu of the Print Film dialog box, the 1024 image will be
binned before sending it to the printer.
• The second check-box allows the operator to choose whether or not use bilinear
interpolation when magnifying 512 Mode images (affects Mag and Zoom functions).
When checked, the software uses bilinear interpolation processing. When not checked,
the software uses pixel replication.
Recommended Settings
• Use 2 X 2 Averaging: Checked.
• Use Bilinear Interpolation: Checked.
Hologic recommends enabling both of these options to improve the quality of the displayed
images.

Figure 6-21: DICOM Queries Preferences dialog box

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12.2 DICOM Query Retrieval

The DICOM Storage Server must be configured to accept DICOM Query/Retrieve requests.
When the DICOM Query dialog box is first displayed, the Patient First Name and the Study
Date fields are grayed-out, preventing entry.
• The operator is required to enter either the Patient ID or the Patient Last Name (or both)
in the query.
• When either the Patient ID or the Patient Last Name has been entered, the Study
Date field is enabled.
• An entry in the Study Date field is optional, and can be used to limit the number of
matches to the query.
• When an entry is made in the Patient Last Name field, the Patient First Name field
is enabled.
• An entry in the Patient First Name field is optional, and can be used to limit the
number of matches to the query.
In the DICOM Query dialog box, the user may enter a Patient ID, partial Patient Last Name
or partial Patient First Name, and if desired a Study Date (yyyymmdd format), for the query.
The user then may select a Query Server from a drop-down list.

Figure 6-22: DICOM Query Dialog Box

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The DSM directory list and file manager list are updated to include the retrieved images.
1. Click OK to send the query. The query results are displayed in the DICOM Query Results
and Retrieve dialog box, in a list containing Patient Id, Patient Name, Study Date, and
Study Time.

Figure 6-23: DICOM Query Results and Retrieve dialog box

2. Scroll, if necessary, and click (highlight) the desired Case Studies to retrieve (one or
more), then click OK. All of the images for the selected Case Studies are copied from
the Query Server to the DSM's resident disk. The DICOM Query Results and Retrieve
dialog box are removed when the retrieve is completed. The File Manager Image List
and Directory List are updated to include the retrieved Case Studies.
3. Click Cancel to stop without retrieving any Case Studies.

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DICOM Image Retrieval Status

13.0 DICOM Image Retrieval Status Messages

While images are being retrieved, the heading of the dialog box is replaced with: Retrieving
Patient ID: xxx. After each case has been retrieved, the number of images retrieved is also
displayed. When all of the selected cases have been retrieved, an overall success/failure
status message is displayed.
• If no errors were detected:
All images were retrieved
successfully. Retrieved xxx images in
xxx Case(s).
• If any errors were detected, the following status message is displayed:
Errors while retrieving images:
xxx Case(s) had errors.
xxx Case(s) retrieved successfully.
The DICOM standard does not allow different Patient Names for the same Patient ID. The
software does not allow the Patient Name to be changed, and displays the following
error message:
A patient with this ID already exists.
The Patient Name can not be changed.

Use the Re-Annotate function if the Name or ID are incorrect.

14.0 Dicom Query Alert Messages

When performing DICOM queries, if the query results in more than 20 matches, the
following Alert message is displayed:

Figure 6-24: DICOM Query Status Message

The Alert message informs the operator that more specific query parameters are needed.

Note… If you get this message, the first 20 matches may be displayed after
clicking the “OK” button. No more matches will be displayed after the
first 20.

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15.0 The Operation Menu

Use the Operation Menu on the right side of the File Manager Window, below the Image List
to initiate File Manager operations.

Figure 6-25: The Operation Menu

Table 6-7: Operation Menu Functions

Menu Item Description
Erase Erases an image or group of images from any of the available local storage devices.

Copy Copies an image or group of images from one storage device to another.
Move Copies the selected Images to the destination device, then erases the just copied Images
from the source device.
Print Film Prints selected files from any storage device to an attached film printer. The entire Print
sequence is detailed in “Printing Methods” on page 96.
Recall Displays any selected Image from a local archive disk to the DSM screen for viewing. The
recalled image appears in the Active Image window, and the remaining associated images
appear in the Case Study area. The entire Recalling a Case Study sequence is detailed in
“Recalling A Case Study” on page 78.
Close Exits File Manager and returns to the DSM Main Menu.

The following sections provide example sequences for each of the File Manager operations.

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15.1 Erase Images

Images can be erased from the resident disk or any local archive disk.
1. Select the Source Device field to open the drop-down menu.
2. Select the desired device.

Note… To select or unselect, point and click.

The File Manager searches the selected source device, then displays all of the Images
stored on the source in the Image List.
Set desired confirmation option:
• To perform operations with view confirmation, check the View Images box.
• To perform operations without view confirmation, un-check the View Images box.
It is good practice to check View Images, especially when erasing image files since the File
Manager does not have a recovery undo feature once the operation is performed.
If a disk is not inserted in the drive, the following dialog box appears:

Figure 6-26: The Device Is Not Ready Dialog Box

To clear the message:

1. Click OK.
2. Insert a disk in the proper drive.
3. Start the sequence again.
Select the desired Search Function (see “Initiate Search Options” on page 78):
The File Manager lists only those Images containing the entered search criteria. If the
source device does not contain any Images with the specified search criteria, the DSM
displays the following message:

Figure 6-27: No Match Found Dialog Box

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1. To clear the message, click OK.

2. Key in different criteria for the selected Search Function, or selected another Sort option.
3. Click Search to initiate a new search.
4. If it is necessary to display all the Images on the source device after a search, click
List All.
5. If the search finds more Images than the Image List can display, use the scroll bar
to navigate up or down through the list.
The user can now arrange the displayed Images using any of the Quick Sort options
(See“Quick Sort” on page 75).
If the View Image option is not selected, the File Manager only prompts the user to confirm
the Erase operation one time. The following Confirmation dialog box appears:

Figure 6-28: Erase Confirmation Dialog Box

To cancel the erase sequence, click No to immediately return to the File Manager Window.
All the previously selected images will remain highlighted.
To continue the Erase procedure:
1. Select or unselect images as necessary.
2. Check the View Images option, if needed.
3. Restart the sequence by clicking Erase.
4. Click Yes to erase all the selected images without further confirmation.

Note… To select or unselect, point and click.

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If the View Image option is selected, the File Manager recalls the first highlighted image to
the screen, and the following confirmation dialog box appears:

Figure 6-29: Image Erasure Confirmation

If image is to be erased click Yes, if image is not to be erased, click No.

Table 6-8: Erase Image Confirmation Actions

Action Result
Yes The File Manager erases the image, recalls the second highlighted image to
the screen, and re-displays the Confirmation dialog box.
No The File Manager skips the erase function for that image, recalls the second
highlighted image to the screen, and re-displays the Confirmation dialog
box.

The confirmation/erase process is repeated for every highlighted image. When all the
images are confirmed, the File Manager Window appears. The Image File List refreshes,
showing only the remaining Image Files. Another erase sequence can be started by
repeating this entire process. If all File Manager operations are complete, click Close to
return to the DSM Main Menu.

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16.0 Copy Images

Note… To select or unselect, point and click.
1. Select the Source Device (for example, resident or local archive disk).
2. Select the Destination Device:
a. Insert the storage media into the appropriate drive (if required).
b. Click the Destination Device field to open the drop-down menu.
c. Click the desired choice to select.
3. Set desired confirmation option (for details see “Erase Images” on page 90).
4. Select the desired Search Function (for details see “Initiate Search Options” on page 78).
The File Manager lists only those Images containing the entered search criteria. If the
source device does not contain any Images with the specified search criteria, the DSM
displays a message (see Figure 6-27).
5. If the search finds more images than the Image List can display, use the scroll bar to
navigate up or down through the list. The user can now arrange the displayed images
using any of the Quick Sort options described in “Quick Sort” on page 75.
6. Select (highlight) images (to copy, erase or move):
• Click any Image to select only that image.
• Double-click any one image to select all images in a Case Study.
• Hold the Shift key, click one image, then on a second to select all the images
in between.
• Click Select All to highlight all the images in the Image List.
You can select as many single images as desired by clicking once on each Image. Double-
clicking an Image is a quick way to select an entire Case Study. The group method (holding
the Shift key) is typically used to select blocks of Images.
Images can be unselected by reversing the selection process. Click a highlighted image to
unselect only that image, or double-click an image to unselect a Case Study. To unselect all
the highlighted Images, click Unselect All.
Initiate the Copy sequence:
1. Ensure that the View Image option is set as desired.
2. Ensure that all of the desired Images are highlighted.
3. Unselect any Images highlighted by mistake.
4. Click Copy to initiate the sequence.

Note… An Alert message appears if a destination device is not selected, or if

a problem occurs during a copy to a DICOM Storage Server.
If the View Image option is not selected, the File Manager only prompts the user to confirm
the Copy operation one time. The following Confirmation dialog box appears:

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Figure 6-30: File Copy Confirmation

To cancel the copy sequence:

1. Click No to immediately return to the File Manager Window.
All of the previously selected Images remain highlighted.
To continue the copy sequence:
1. Select or unselect Images as necessary.
2. Check the View Images option if needed.
3. Restart the sequence by clicking Copy.
4. Click Yes to copy all the selected images without further confirmation.
If the View Image option is selected, the File Manager recalls the first highlighted image to
the screen, and the following confirmation dialog box appears:

Figure 6-31: Copy Image Conformation Dialog Box

If image is to be copied click Yes, if image is not to be copied, click No. The confirmation/
copy process is repeated for every highlighted Image.

Table 6-9: File Management Confirmation Actions

Action Result
Yes The File Manager copies (or moves) that image only to the Destination
Device, recalls the second highlighted image to the screen, and re-displays
the Confirmation dialog box.
No The File Manager skips the copy function for that image only, recalls the
second highlighted image to the screen, and re-displays the Confirmation
dialog box.

When all the Images have been confirmed, the File Manager Window appears. Another copy
sequence can be started by repeating this entire process. If all File Manager operations are
complete, click Close to return to the DSM Main Menu.

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17.0 Move Images

1. Select the Source Device.
2. Select the Destination Device.
3. Set desired confirmation option.
4. Select the desired Search Function.
5. Quick Sort the Image File List.
6. Select (highlight) images to move.
7. Initiate the Move sequence:
a. Ensure that the View Image option is set as desired.
b. Ensure that only the desired Images are highlighted.
c. Unselect any Images highlighted by mistake.
d. Click Move to initiate the sequence.
If the View Image option is not selected, the File Manager only prompts the user to confirm
the move operation one time. The following Confirmation dialog box appears:

Figure 6-32: The Move Selected Images Confirmation Dialog Box

To cancel the move sequence

1. Click No to immediately return to the File Manager Window. All of the previously
selected Images remain highlighted.
2. Select or unselect Images as necessary.
3. Check the View Images option, if needed.
4. Restart the sequence by clicking Move.
5. Click Yes to move all of the selected images without further confirmation.
If the View Image option is selected, the File Manager recalls the first highlighted image to
the screen, and the following confirmation dialog box appears:

Figure 6-33: The Move Displayed Images Confirmation Dialog Box

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Recall Button

Examine the image on-screen to confirm that it is an Image to move. If it is not, or you
are unsure, click No. The File Manager will skip the move function for that Image, recall
the second highlighted image to the screen, and re-display the Confirmation dialog box. If
the image is to be moved, click Yes.
The confirmation/move process is repeated for every highlighted Image. Continue with the
confirmation actions until the File Manager operations are complete.

18.0 Recall Button

To recall an image to the screen:
1. Select the Source Device.
2. Insert the storage media (DVD/CD) into the appropriate source drive.
3. Click the Source Device field to open the drop-down menu.
4. Click to select the local Archive Disk. Only the Archive Disk is valid when using
the Recall operation. If the source device is any other storage media, an error
message appears.
5. Select the Image to recall.
6. Use a Search function to narrow the search for an Image.
7. Use the Quick Sort feature to arrange the list as desired.
8. Use the scroll bar to move up and down through the list.
9. Highlight the desired Image to Recall.
10. Click the Recall button on the Operation menu.
The DSM automatically closes File Manager, and the selected Image is immediately
displayed.

Note… Although a recalled image can be enhanced using the enhancement tools,
it cannot be saved with these enhancements. Changing an Image File on
an archive disk is not permitted.

19.0 Printing Methods

The DSM permits the operator to print film images on a DICOM compatible printer using
either the Print Screen or Print Film method. In addition, the Print Screen method allows
the user the option to save the image file as a Windows Bitmap (.bmp) file onto a floppy
disk or to the hard disk.
Use the Print Screen method to obtain a film or bmp file of any displayed DSM screen. This
method is initiated by clicking on the Print Screen button from the DSM Main Menu.

Note… This option is used for 512 images only.

Images stored on the DSM resident disk can be printed to a laser film printer directly from
the File Manager Window. This option opens the print utility which offers a variety of
print format options.

Note… This option is the recommended print method.

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19.1 Print Screen

Use the Print Screen option (from the DSM Main Menu) to obtain a screen-capture of the
currently displayed screen, of one or both of the images displayed in the Active Image
Window.
If the Print Screen function is being used to save a file to floppy disk, insert a blank, formatted
3.5" floppy disk in the floppy disk drive, then proceed to step #2. If Print Screen is being
used to save images to the hard disk, proceed to step #3.
Prepare system for printing:
1. Ensure that the DICOM compatible printer is powered on and on-line.
2. Ensure that the printer has laser film loaded.
Initiate the Print Screen option:
1. Acquire or recall any image, or image pair, to the DSM screen.
2. Click Print Screen button on the DSM Main Menu.
The Print Screen dialog box appears on the DSM screen:

Figure 6-34: Print Screen Dialog Box

The Print Screen dialog box offers fields for selecting the print Contents, choosing the
Destination, and entering the number of copies to print. To immediately terminate the Print
Screen function, click Cancel at the bottom of the dialog box.
Select Contents:
1. Click field to open drop-down menu.
2. Click desired choice.
• Select Left Image or Right Image to print only the image shown in the left or
right Active Image Window.
• Click Image Pair to print both images in the Active Image Window.
• To print the entire screen, including the Annotation Area and the Case Study,
click Entire Screen.

Note… Left Image and Right Image are printed in portrait orientation. Image Pair
and Entire Screen are printed in landscape orientation.

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Select Destination:
1. Click field to open drop-down menu (see Figure 6-35).
2. Click the required option.

Figure 6-35: Print Screen Dropdown Menu Options

The drop-down menu options are the DICOM compatible printers set up for use with the
DSM. When more than one DICOM compatible printer is connected, the drop-down
menu will list them all, in addition to the print File to Floppy Disk and print File to Hard
Disk option (see Figure 6-35). Select the laser film printer to use, or click File to Floppy to save
the image as a bmp to the installed diskette or Bmp File to Hard Disk to save the image as a
bmp to the hard drive.

Note… Selecting “Bmp File to Hard Disk” destination results in a bmp file being
written to the C:/temp directory. Filenames are in the format
DSM_PSXX.bmp where XX is a number between 01 and 50. Each time
the DSM program is restarted, the sequence will start over with
DSM_PS01.bmp. Any existing bmp files will be overwritten.Also, after the
50th image, the file naming will start over with DSM_PS01.bmp, which
will overwrite the first BMP file saved to the hard disk.
Enter the number of copies to print:
1. Click in the Copies data field.
2. Key in the number of films to print.
3. When all the fields have been filled, initiate the print sequence by clicking OK.
The DSM computer sends the image to the selected DICOM compatible printer for output to
film, or export the image in the Windows Bitmap (.bmp) format, then save it to the floppy
diskette.

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When the print sequence is complete, the following dialog box appears:

Figure 6-36: Print Sequence Dialog Box (Floppy Disk option shown)

The DSM prompts the user whenever a print error occurs. Below are examples of some of the
situations that can cause print errors:
• Floppy disk full (insert blank floppy)
• Floppy not found (insert a formatted floppy disk)
• Unable to establish association with printer (Printer is powered off or is off-line)

Note… To access the desktop to view bmp file images, click Exit Program.
While the Confirmation dialog box is on the screen, click Yes while
pressing the Shift and Control keys simultaneously.
To return to the DSM Main Menu, double-click on the LORAD-
DSM desktop icon.

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19.2 Print Film

The Print Film utility is accessed from the File Manager Window and is used to print images
to a DICOM compatible film laser printer. The user must select the images to print using
File Manager, then after initiating the print sequence, select the film format.

Note… The system will not separate stereo pairs when printing.
To print a film using the Print Film method, verify that the DICOM compatible printer is
powered on and on-line, and that it has laser film loaded, then follow these steps:
Initiate the Print Film sequence:
1. Open File Manager by clicking on the DSM Main Menu choice.
2. Select the source device containing the images to print.
3. In the Image List Window, select the image or images to print.
4. Click Print Film from the Operation Menu.
The user can use any of the available search options or quick-sort methods in the File
Manager to narrow the search for the images to print. The following dialog box appears:

Figure 6-37: Print Film Dialog Box

Select the Destination Printer:

1. Click the Destination option to open the drop down menu.
2. Click the DICOM compatible printer attached to the DSM.
When more than one DICOM compatible printer is connected to the DSM, the drop-
down menu lists them all. Choose the required printer from the list of available film
formats (see Figure 6-38).
Enter the number of copies to print:
1. Click in the Copies data field.
2. Key in the number of films to print.

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Select the Film Format:

Click the Film Format choice to open the drop down menu.
• To print one image per film, click the 1 x 1 choice.
• To print 4 images per film, click the 2 x 2 choice.
• To print 6 images per film, click the 3 x 2 choice.
• To print 12 images per film, click the 4 x 3 choice.

Figure 6-38: Available Film Formats

Select print resolution:

Click the Print Resolution choice to open the drop down menu.
• Click Low 512 to print the images at 512 x 512 film resolution.
• Click High 1024 to print the images at 1024 x 1024 film resolution.
The film format and print resolution will determine the size of each image on the printed
film. Choosing a multiple image film format may require the printer to resize each image in
order to fit them all onto one film. Also, the print resolution selected will affect the film size.
Images printed using the high resolution mode may appear larger on film than images
printed using the low resolution mode.
The resolution of the printer determines print resolution. Print resolution is independent of
whether the image is 512 or 1024. 1024 is preferred (provided the printer is capable of
printing the higher resolution mode).

Note… The system will not separate stereo pairs when printing.

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When all the fields have been filled, initiate the print sequence by clicking OK. The DSM
computer will send the images to the selected DICOM compatible printer for output to film.
When the print sequence is complete, the following dialog box appears:

Figure 6-39: Print Sequence Completed Dialog Box

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20.0 The Re-Annotate Utility

The Re-Annotate utility allows the user to modify previously entered Annotation data. The
new Annotation data is saved with the Image, replacing the previous Annotation data. This
utility is typically used to correct errors made during Annotation when the image was
originally acquired.
The DSM will not permit the user to change all of the Annotation information. Data such as
the time and date, the Mode, and the exposure techniques are not available for change
with the Re-Annotate utility. The Annotation information that the user can change is:
• Patient ID
• Patient Name
• Operator
• View
• Comment
• Compression (stereo images only)
• Patient Date of Birth
• Patient Sex
• Referring Physician
• Accession Number
• Procedure Code

20.1 Re-Annotating the Image File

The following presents an example sequence for Re-Annotating an Image. Note that all of
the fields that can be selected for change need not be modified every time the Re-
Annotate utility is used.
Recall the image to the screen:
1. Click Directory List from the DSM Main Menu.
2. Locate the Case Study to recall in the Case Study Window.
3. Double-click the Case Study to bring it to the DSM screen.
Note that by default the DSM will show the Scout View (if part of the Case study) in the left
side Active Image Window. From the Directory List Window, you can choose a particular
Image to display in the Active Image Window by double-clicking on the exact image from
the Image List.
Select Image File to Re-Annotate:
1. Locate the image to Re-Annotate from the Case Study Area.
2. Double-click the thumbnail image to bring it to the left side Active Image Window.
The Re-Annotate utility only permits Annotation data changes to scout images when the
Image is in the left side Active Image Window. To Re-Annotate stereo images, both images
of the pair must be shown on-screen (i.e., a single image cannot be shown on the right side
window).

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Chapter 6—DSM Operations
The Re-Annotate Utility

Start the Re-Annotate Sequence:

1. Ensure that the desired Image is shown in the left side Active Image Window.
2. Make any image enhancements as needed.
3. Save the image.
4. Click Re-Annotate from the DSM Main Menu.
If the Image to re-annotate has been previously archived, the following warning dialog box
appears on-screen:

Figure 6-40: Re-Annotate Dialog Box

To immediately terminate the Re-Annotate sequence, click Cancel, otherwise click OK. The
Image can now be re-annotated by selecting and modifying the choices in the Re-Annotate
dialog box shown on-screen:

Figure 6-41: Re-Annotate Image File Screen

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The following fields may be changed as necessary.

Re-Annotate the Image File:
• Modify the data in the Patient ID field.
• Modify the data in the Patient Name field.
• Select a new Operator code.
• Change the clinical View and Left/Right.
• Modify/Select a new Comment line.
• Correct the breast Compression thickness (stereo images only).
• Modify the data in the Patient DOB field.
• Patient Sex (select)
• Referring Physician
• Accession Number
• Procedure Code
The user can elect to terminate the Re-Annotation sequence at any time by clicking Cancel.
Any changes made to the annotation fields are nullified, and the Image remains in its
original state. To save the new Annotation data, click OK.

Note… Changes made to the Patient ID, Patient Name, Operator, Left/Right, Patient
DOB, Patient Sex, Referring Physician, Accession Number, or Procedure
Code fields will change the same annotation data for every Image in the
Case Study.

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Chapter 6—DSM Operations
The Auto Archive Utility

21.0 The Auto Archive Utility

Note… DSM images from previous versions cannot be archived to a DICOM server.
The Auto Archive feature is a DSM utility that automatically saves new Case Studies
(previously un-archived) to archive media. In addition to archiving new Case Studies, the
Auto Archive utility also maintains the minimum level of free space on the resident disk by
removing the oldest files that have been previously archived.
The DSM requires a minimum level of free space on the resident disk to ensure that there is
adequate room to acquire new images. When the free space on the resident disk falls below
the minimum level, the Auto Archive utility automatically removes previously archived
cases, starting with the oldest. The Auto Archive utility continues to delete cases from the
resident disk until the available space on the resident disk exceeds the minimum level
required for operation.

21.1 DICOM Server

There is the added ability to send images to a DICOM server. The storage server must
support digital mammography images (modality = MG), in order for this to work. A
DICOM Server Setup button on the Setup menu allows the operator to configure up to three
DICOM storage servers. Any of the servers configured for storage can be selected as the
destination for a File Manager Copy operation, by selecting it from the File Manager
Destination Device
pull-down menu.
There is also the added ability to send all images to a DICOM server for long term archiving.
Any properly configured DICOM server that supports digital mammography storage can be
selected as the Auto Archive destination by selecting it from the Archive Destination pull-
down menu in the Auto Archive Setup dialog box.

21.2 Storage Commitment

As an Option, the software can request Storage Commitment (confirmation that the image
has been stored on the server) if it is supported by the server.
To verify DICOM connectivity to a server, three DICOM Echo buttons are provided. The
DICOM Server Setup dialog box has two Echo buttons (Storage, and Modality Work list
servers). The third Echo button is in the DICOM Print Setup dialog box (Print server). When
the DICOM Echo button is pressed, a message is displayed indicating either a successful
connection, or a failure.

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21.3 Auto Archive Utility Example Sequence

The following steps provide an example sequence for the Auto Archive utility.
Prepare DSM System for Auto Archive:
1. Close any open utility window (i.e., File Manager, Directory List, etc.).
2. Insert the archive media into the DVD/CD drive (if necessary).
Begin the Auto Archive Sequence:
1. Locate the Auto Archive button on the Main Menu.
2. Click Auto Archive to initiate the archiving sequence.

Note… The Auto Archive function is also automatically started when the DSM
program is exited.
One previously un-archived (new or re-annotated) Case Study must be present on the
resident disk when the Auto Archive sequence is started. If there are no new cases on the
resident disk, the Auto Archive utility will terminate after momentarily showing this dialog
box:

Figure 6-42: No New Cases to Archive Dialog Box

If there are new cases to archive, the DSM will show the following Confirmation dialog box:

Figure 6-43: Number of Cases to Archive Dialog Box

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Chapter 6—DSM Operations
The Auto Archive Utility

Click No to terminate the Auto Archive sequence immediately. The utility is canceled, and
no cases are archived or deleted. To begin the sequence, click Yes. The Auto Archive begins
saving the new cases to the archive, and if necessary, it removes the old previously
archived cases from the resident disk. During the archive process, the following dialog box
appears:

Figure 6-44: Archive Progress Dialog Box

When the Auto Archive process is complete, the utility automatically terminates after
momentarily showing the following dialog box:

Figure 6-45: Archive Complete Dialog Box

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Chapter 6—DSM Operations
DSM CD/DVD Archive
Media

22.0 DSM CD/DVD Archive Media

The following chart illustrates the various pros and cons for each of the supported disk
formats. Each user will have to decide which format best suits their individual needs.

Table 6-10: Disk Format Options—Pros and cons

Disk Type Re-writable Capacity Speed
(approximate formatted) (Make Database)
CD-R No 664 MB (80 min. disk) 1.5 min.
CD-RW Yes 530 MB (74 min. disk) 1.0 min.
DVD+R No 4.45 GB 14.0 min.
DVD+RW Yes 4.48 GB 6.5 min.
Note: Speed is the time that it will take to read a full disk and display the image list (using
DSM File Manager).

22.1 DSM CD/DVD Formatting

Regardless of which type of media is used, it will have to be formatted before it is used in
the DSM system. To format a CD or DVD disk:
1. Insert a blank disk into the DVD drive. (CD-R, CD-RW, DVD+R, or DVD+RW disks can
be used). Please note that DVD-R, DVD-RW, and DVD-RAM media are not
supported. (The DVD drive only supports the “+” versions of DVD media).
2. To access the desktop to view bmp file images, click Exit Program.
3. While the Confirmation dialog box is on the screen, click Yes while pressing the Shift
and Control keys simultaneously.
4. Select My Computer from the Windows desktop or Start button.
5. Right-click the drive letter of the DVD drive. This is drive letter D in the
current Multicare Platinum implementation. A pop-up menu will be displayed.
6. Select Format on the pop-up menu. The DirectCD Format dialog box should appear.

Caution: Ensure that drive C has not been selected for formatting, as this will erase
all data on the resident disk. (The drive letter is displayed in the title bar of
the Format dialog box - Do not continue unless the words Drive D are
displayed).

7. Set the options in the Format dialog box:

In the Label text box, type a name to identify your disk. (This is optional and can be left
blank). The CD label can be up to 11 characters. You cannot use the following characters in
a label: \ / : ; * ? " < > | + = . , [ ].
Do not select Enable Compression. (No check-mark). Checking this feature (selecting) is not
recommended because of compatibility and speed issues.
Select the Format Type that you wish to use.

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DSM CD/DVD Archive
Media

Usually, the correct Format Type will already be selected, and no other Format Type
options are available. However when formatting a CD-RW or a DVD+RW you may have
these options:
Quick Format—Quick format takes much less time than full format. It writes the DirectCD
file system to the disc, but does not verify the physical condition of the disc. If the disk has
been previously used, any files that were on the disc will not be accessible, but they are
still on the disc.
Full Format—Takes much longer than quick format. It writes the DirectCD file system to the
disc, and verifies the integrity of the entire disc surface. If the disk has been previously
used, any data that was on the disk will be completely erased.

Table 6-11: Disk Format Options—by Media Type

Disk Type Quick Format Full Format
CD-R 10 sec. N/A
CD-RW N/A 11 min. 36 sec.
DVD+R 30 sec. N/A
DVD+RW 1 min. 44 sec. 45 min.
Quick Format is not supported by all brands of DVD+RW media

1. Select the Start Format button.

Note… After formatting, the first time that the disk is ejected from the drive, there
is a delay while the formatting software writes additional information to the
disk. This delay is only a couple of seconds for a CD, however it can take
two to three minutes to eject a DVD. This delay only occurs the first time
that the disk is ejected.
2. To return to the DSM Main Menu, double-click the LORAD-DSM desktop icon.

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Chapter 7—Clinical Procedures
User Calibration and Verification

Chapter 7—Clinical Procedures

1.0 User Calibration and Verification

Z ZERO PRESETS Mode permits the storage of a Z coordinate Biopsy Instrument or needle
length calibration value for each operational mode: FNA, Wire Loc, and NCB. The preset
function allows the user to enter the length value into memory in advance of a clinical
procedure.

1.1 Preset Needle Calibration

During a clinical procedure, the stored calibration value determines the Z axis zero point,
from which needle or Biopsy Instrument depth is referenced. The stored calibration value is
in effect unless the operator overrides it by performing a Z ZERO operation (calibrates
another needle) during the procedure. When the stored value is in effect, the message
PRESET appears on the Stage Display operational mode screens.
To enter preset needle length calibration values, do the following (all controls named in the
following are those located on the Stage Assembly):
1. If necessary, use the CURSOR key to select MODE, and the Enter key to switch the
mode of the display to Z ZERO PRESETS. Each operational mode is listed on the Z
ZERO PRESETS screen.
2. Use the CURSOR key to select the mode to be calibrated.

Figure 7-1: Z Zero Presets Mode Display

3. Install the Biopsy Compression Paddle.

4. Compress QA phantom - maximum compression.
5. Fit the stage with the Biopsy Instrument (or needle) and its accessories (holder, needle
guide mount, needle guides, etc.) as appropriate for the operational mode procedure.
In the case of needle core biopsy, before mounting the biopsy device on the MultiCare
Platinum, install a needle into the biopsy device and cock the device to place the
needle at the correct pre-fire position.

Warning: Make sure to apply the biopsy device safety before handling. Never
cock the device while it is mounted on the MultiCare Platinum
stage.

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User Calibration and Verification

6. Using either the manual X-Y controls, or the motor-assist (MOTOR ENABLE +
Z- POSITION), move the stage to the X=0, Y=4 position.
7. Rotate the Z knob to align the tip of the installed Biopsy Instrument/Needle so that
the bevel of the needle tip is just below the reference hole.
8. With the Biopsy Instrument/Needle so positioned, press Enter. The selected
operational mode line on the Z ZERO PRESETS screen will display the message
“PRESET”.
9. If other needles are available to calibrate lengths to the Stage Assembly, use the
CURSOR key to repeat the Z Zero Preset process for the other operational modes.
10. Upon returning to the operational mode in which Z ZERO was just preset, the Stage Z
Coordinate will show 0.0 (if the Z-knob was not moved). The message “PRESET” will
appear in the upper right of the Numerical Display and Graphic Display screens.

Note… During clinical procedures, when using a Biopsy Instrument/Needle length

that is different from the length used during the Preset process, establish and
zero the new length value. Using sterile techniques, align the Biopsy
Instrument/Needle with the reference point and press the Z ZERO key on
the stage. The Stage Z Coordinate will show 0.0 and the PRESET message
will disappear, indicating that the preset Z Zero value is not in use. To return
to the preset value, press the Z ZERO and Enter keys simultaneously.

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Chapter 7—Clinical Procedures
Preparing The Stage

2.0 Preparing The Stage

The function of the Stage is to provide a means of positioning a Biopsy Instrument/Needle
to the point(s) identified and targeted in the stereo images. The Stage receives target
coordinates from the DSM and displays them. It also displays the current position of the
Biopsy Instrument/Needle. When the current position of the instrument equals the target
coordinates, the instrument is in position to obtain a biopsy of the area of interest. The
operations required in the use of the Stage are explained in the following.

2.1 Mode Selection

The Stage Display has four operating modes, three of which correspond to the clinical
procedures for which the MultiCare Platinum is intended:
• Needle Core Biopsy (NCB)
• Fine Needle Aspiration (FNA)
• Wire Localization (Wire Loc)
In addition, the fourth mode: Z ZERO Presets, allows an operator to preset a needle length
calibration value for each of the three operational modes.

Note… The Needle Core Biopsy (NCB) Mode is also used for Large Core
and Vacuum-Assisted Biopsy procedures.
To change the Stage Display to the appropriate mode, perform the following steps:
1. Place the display cursor, which appears on the display screen as a reverse video box,
on the MODE line of the display by pressing the Stage CURSOR key to move it through
the selectable items to the MODE line.
2. To change the Mode, press the Enter key. Each press of the Enter key switches the current
MODE shown on the Stage Display among the available selections: NCB, FNA, Wire
Loc, and Z ZERO Presets.

2.2 Entering Biopsy Instrument Parameters

In the NCB Mode, enter the Stroke value. Stroke is the distance that the needle moves
when the biopsy device instrument is fired.
To enter the Stroke value:
1. Use the Enter key to access the NCB mode screen.
2. Press the CURSOR key to move the Cursor to the STROKE line of the display.
3. With the Stroke line highlighted, press the Enter key to scroll the Stroke value through its
range of 10.0 to 25.0 mm.
4. When the proper Stroke value for the Biopsy Device to be used displays, press the
CURSOR key to return the Cursor to the Mode line. The Stroke value selected remains
displayed on the Stroke line.
In the FNA and Wire Loc Modes the Minimum Needle Length is calculated by the DSM
program, therefore, no parameter need be entered.

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Chapter 7—Clinical Procedures
Acquiring a Single Image

3.0 Acquiring a Single Image

The Single Image Acquisition Mode is typically used to obtain a pre-stereotactic single
image, or to acquire a post-exam specimen image. Single Image Acquisition is conducted
using one of two modes:
• Acquire 512 (512 x 512 pixel resolution)—better contrast
• Acquire 1024 (1024 x 1024 pixel resolution)—better spatial resolution, but uses 4x the
storage space and 2x the dose.
The Acquire Single image sequence is launched by selecting one of the two choices from
the Main Menu. The following paragraphs describe how to prepare the DSM and the
MultiCare Platinum for the exam, and present an example sequence of operation to acquire
a single image.

Note… At startup, the CCD chip in the digital receptor requires ten minutes to
reach its operating temperature. During this cool-down period, X-ray
exposures are not permitted.

Figure 7-2: Main Menu Acquire Image Selections

3.1 System Preparation

Typically this procedure is performed before the patient enters the room. The following steps
are needed to prepare the X-ray unit for use with the DSM: see Chapter 5—Preparing the
System for Use for full details.
1. Install Digital Accessories:
a. Install the Digital single aperture into the unit’s aperture slot in the tubehead.
b. Attach the appropriate Compression Paddle to the Stage.
2. Turn on the Host System:
a. Ensure that the input power cord is connected.
b. Perform all pre-power on inspections.
c. Apply power to the MultiCare Platinum (See “Power Up Procedures” on page 37).
d. If the camera is shared, verify the system READY status.
e. Cover the Table Control Panel with the plastic bags sent form Hologic (See Console
Preparation.

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Acquiring a Single Image

Typically this procedure is performed before the patient enters the room. The following steps
are needed to prepare the DSM to acquire a single image:
1. Power up the DSM Console:
a. Perform ALL pre-power on checks before switching the unit ON.
b. Remove the floppy diskette from the disk drive (if installed).
c. Perform the Start Up Sequence: “Start Up Procedures” on page 38.
d. Select MultiCare Platinum (from on-screen dialog box) to set proper white fields.
See Figure 4-2.
e. Ensure the system accesses the DSM Program Screen (Main Menu) without error.
2. Choose Main Menu Display:
• Press Alt + M keys at the same time to toggle between labeled buttons and icons
for the menu display.
3. Install Archive Media.
• Ensure that an archival media disk is installed in the DVD/CD drive.

3.2 Choose the Single Image Acquisition Mode

• Point and click Acquire 512 to begin the sequence to acquire a single 512 resolution
image.
• Point and click Acquire 1024 to begin the sequence to acquire a single 1024 resolution
image.
Depending on the displayed Main Menu, the options appear as icons (default) or labeled
buttons.

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Chapter 7—Clinical Procedures
Acquiring a Single Image

3.3 Annotate the Image—Existing Patient

After selecting the acquisition mode, the following Annotation Dialog Box appears:

Figure 7-3: The Patient Annotation Dialog Box

The Annotation dialog box prompts the user to enter unique information regarding the
patient and the ensuing exam. This unique data must be entered before the system
will permit an exposure.

Note… An entry must be made for Patient ID, Patient Name, and Operator ID,
and Left or Right must be selected before the system will permit an
exposure.
To add the new image to an existing case study (all images taken of the same patient on the
same day), do not change the patient name or Patient ID fields in the dialog box.

Note… If a DICOM Modality Worklist Server is configured (See Chapter 4), the
View Worklist button (below the New Patient button) is enabled.

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1. Click View Worklist to display the Patient Worklist dialog box (Figure 7-4, p. 117),
listing the Patient ID, Patient Name, Study Date, and Study Time for each of the day's
scheduled procedures. The list may be sorted by Patient ID, Patient Name, or Study
Time. The column headings act as sort buttons.
2. Scroll, if necessary, and click (highlight) the desired patient, then click OK. The Patient
Worklist dialog box closes, and the Annotation dialog box is filled in automatically with
the information received from the DICOM Modality Worklist Server.
3. Click Cancel to close the Patient Worklist dialog box without making a selection.
When the OK button is selected in the Patient Annotation dialog box, the software checks
the lengths of the entries in the Patient ID, Patient Name, and Operator fields. If more than 31
characters have been entered, the operator is given the choice to truncate the entry or to
manually alter the entry. When importing from the Worklist, the entire character string
(which may be more than 31 characters) is transferred into the Patient Annotation dialog box.
When the OK button is selected, the lengths of the entries are checked in the same manner
as if they had been manually entered.
A maximum of 31 characters of the Patient ID, Patient Name, and Operator fields are saved
and recalled with each image. However, only the first 21 characters are displayed in the
annotation fields above the image. The Directory List, File Manager, Worklist, and Query
Results dialog boxes will display from 16 to 31 characters (proportional character set –
depends on upper/lower case, and the actual letters typed). The Patient Annotation dialog
box will always display all of the characters.

Note… The fields for Patient ID, name, and Operator sort in ascending order.
Study Time and Date (study) sorts both in ascending and descending
order.

Figure 7-4: The Patient Worklist

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If a Patient Worklist is unavailable, an alternative to View Worklist is to enter a Patient ID,

then press TAB on the keyboard to advance to the Patient Name field. The Annotation
dialog box is filled in automatically with the information received from the DICOM
Modality Worklist Server, if any, for the entered Patient ID.
If the Worklist is empty, the DSM automatically tries to retrieve a new Worklist before
reporting that there are no items in the Worklist.
A Retrieve Worklist button located at the bottom right of the Worklist dialog box performs
the same function as the Retrieve Worklist button in the File Menu.

Note… When using the Patient Worklist, the Operator, View, Left/Right, Comment,
and Compression (for Acquire Stereo Image) fields must still be selected
or entered manually.

3.4 Annotate the Image—New Patient

Note… Pressing TAB on the keyboard will also advance the cursor into the
next field in the Annotation dialog box.

Note… Note that the Compression field is not available for single
image acquisition.
If the information to be entered is not part of an existing patient study, point and click New
Patient to clear all the fields in the dialog box, then annotate the image as follows:
1. In the Patient ID field, enter the ID number.
2. In the Patient Name field, enter the name.
3. Select an Operator ID from the drop-down menu, or type a new number.
4. Click Left or Right, indicating on which breast the procedure is being performed.
5. Click a view from the drop-down menu in the Exam View field.
6. In the Comment field, enter any exam comments for the image (up to 32 characters),
or select a comment from the drop-down menu.
7. In the Patient DOB field, enter the patient's date of birth, in the format yyyymmdd
(e.g., 19490609, for June 9, 1949).
8. Select a gender (F, M, O) from the drop-down menu in the Patient Sex field.
9. In the Referring Physician field, enter the name of the referring physician (up to
64 characters).
10. In the Accession Number field, enter the accession number (up to 16 characters).
11. In the Procedure Code field, enter the CPT code for the procedure (up to 16 characters).
Whenever a new operator code or comment is keyed into their respective fields, that code or
comment is automatically added to the field’s drop-down menu for future selection.
The annotation process can be canceled at any time by clicking Cancel at the bottom of the
dialog box. This terminates the single image acquisition process and return to the Main DSM
screen.

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To continue with the exposure after completing the Annotation screen, click OK. The
following dialog box appears:

Figure 7-5: Image Acquisition/X-ray Technique Dialog Box

If the receptor’s 10-minute cooling period has not elapsed, the DSM displays a message
showing the cool-down time remaining. During the receptor cool-down period, X-ray
exposures are not permitted.
The Acquisition dialog box displays a prompt informing the user that the DSM receptor is
waiting for the X-ray to begin. This indicates that the DSM is ready to capture an exposure.
Review the annotation information shown in the top portion of the dialog box for accuracy.
If the information is not correct, click Abort X-ray or press the escape key to terminate the
image acquisition sequence; otherwise proceed with the image acquisition.

3.5 Setting X-ray Technique—Host

To set the X-ray technique on the Host, use the Handheld Console.
1. Select desired exposure mode: Auto-Time or Manual.
2. Select the appropriate kV level.
3. Select the appropriate mAs value if using Manual exposure.

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3.6 X-ray Technique Dialog Box—DSM

The X-ray Technique dialog box allows changing the X-ray technique from within the DSM
user interface.

Note… The DSM does not control the actual X-ray esposure.The MultiCare
Platinum Handheld Console has complete control over X-ray.
The X-Ray Technique dialog box is displayed on the same screen with the existing Waiting
for X-RAY To Begin dialog box (see Figure 7-5, p. 119), and is visible whenever the Waiting
for X-ray To Begin dialog box is visible. The dialog box contains Up/Down spinner controls
(arrows) to allow the increment or decrement of kV and mAs values. Radio buttons select
the Exposure Mode. There are two exposure modes: Manual and Auto-Time.
When the X-ray Technique dialog box is displayed, the handheld console is inactive (the
operator cannot change the X-ray technique at the handheld console).
The X-ray Technique dialog box displays the current kV, mAs, and Exposure Mode values.
Any X-ray technique changes made at the DSM interface are also displayed on the handheld
console. The technique values displayed on the handheld console will track the values
displayed in the X-ray Technique dialog box (see Chapter 3, Section 2.1.1,Exposure System
Displays, p. 31).
AEC Locked
The X-ray Technique dialog box also indicates whether or not the Auto-Time exposure is
locked. When the (Locked) indication is displayed, the MultiCare Platinum uses the
exposure time from the previous image to calculate the new exposure time (AEC is not
used).
When the exposure mode is set to Auto-Time, and a stereo image is about to be acquired,
the text: (Locked) will be displayed. If the exposure mode is set to Manual, or if a scout
image is about to be acquired, there will be no (Locked) indication (AEC will be used).

Note… If Auto-Time mode has been selected, and the operator attempts to acquire
a Stereo Pair without first having acquired a Scout image, the DSM
displays the following warning:
Warning - AEC cannot be used for this exposure!
No Scout images have been acquired for this patient.
When AEC is used for stereo acquisition, the exposure time is taken
from the most recent Scout image.
Exposure Mode will be set to Manual.

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3.7 Cover the MultiCare Platinum Control Panel

Caution: To prevent fluids from contaminating the control panel, a Clear Plastic
Banded Bag (PN 2-700-0072) must be installed.

1. Prior to performing a new patient procedure, cover the MultiCare Platinum Control
Panel with a new Clear Plastic Banded Bag —PN 2-700-0072 (See Figure 7-6). Ensure
the top and sides are completely covered.
2. At completion of the patient procedure, remove the Clear Plastic Banded Bag and
discard in accordance with local, state, or Federal sanitary codes or OSHA Regulations
(as applicable).
3. A sufficient stock of replacement bags should always be kept on hand. Order
replacement bags from Hologic using the following information:
• Clear Plastic Banded Bag—PN 2-700-0072, 25 ea/case.

Figure 7-6: Clear Plastic Banded Bag Installation

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Operator’s
Chapter 7—Clinical Procedures
Prepare the Patient

4.0 Prepare the Patient

1. Position the patient.
2. Place the breast to be examined through the table opening.
3. Center the area of interest in the biopsy window then apply appropriate compression.
Instruct the patient on the importance of remaining stationary during the entire exam.
When the patient is positioned properly, conduct the exposure.

Note… It is very important for the technologist to properly position the patient’s
entire body. Cushion the neck, arms, ankles, etc. so the patient will be
comfortable.

5.0 Make the X-ray Exposure

1. Make final checks of the exposure factors and patient information.
2. Provide final instructions for the patient.

Note… Press and hold the X-ray button(s) until the exposure ends (tone stops).
If the X-ray button is released before X-ray exposure has started, the DSM
will continue to display the Waiting for X-ray dialog box. Press the Reset
button on the handheld console to clear the error, then click Ready X-ray
in the DSM Image Acquisition dialog box to reset the X-ray system to
Ready Mode. Re-take the exposure.
If the X-ray button is released after the X-ray exposure has started, the DSM
will acquire and display the image and return to Stand-by Mode just as it
does for a normal acquisition. Press the Reset button on the handheld
console to clear the error, then select one of the Acquire buttons in the DSM
main menu to re-take the exposure.

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Make Window/Level Adjustments.

6.0 Make Window/Level Adjustments.

The Window/Level display shows the current window/level setting. It displays a
histogram and the digital number value of the image data. It can also be used as an
“exposure level” indicator.

Figure 7-7: Window / Level Histogram Example

Note… A histogram is a special kind of bar graph that shows how many data
values fall into a certain interval. The intervals cover all possible values of
data, therefore there are no spaces between the bars of the graph. The
width of the bar represents the interval, while the height indicates the
number of data items, in that interval.
1. Adjust image contrast by rotating the Trackball up and down.
2. Adjust image luminance (brightness) by rotating the Trackball right and left.
3. Invert and revert the image by pressing Spacebar on the DSM keyboard.
4. Right-click to return the image to its as acquired state.
5. To close the Window/Level window, click the left trackball button.
Adjusting the image contrast and brightness helps to define structures, and can enhance
discernment of differing breast tissues. Inverting the image will make light structures turn
dark and dark structures turn light.
Closing the Window/Level window saves the enhanced image to the Resident Disk. A
thumbnail (small scale) of the just acquired/enhanced image will appear in the Case Study
Display Area (bottom of the screen).
The user can elect to use the options from the Enhancement Menu as required to process
images.

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Use the Enhancement Menu Options

7.0 Use the Enhancement Menu Options

To enter Enhancement Menu, right-click the desired image.
• Select Window/Level to change contrast and brightness.
• Select Invert to reverse each pixel (light-to-dark, dark-to-light).
• Select Zoom to enlarge the image to full screen.
• Select Mag to bring the 2x magnification window to the image.
• Select Tools to choose a measurement tool.
• Select Filter to apply sharpening, smoothing, equalization or multi-
contrast enhancement.
• Select Custom to access enhancement tools from a dialog box.

8.0 Re-position Patient

At this time, determine if the patient can be positioned for the stereotactic imaging process. If
the single image shows that the area of interest in the breast is positioned within the
accessible part of the biopsy window, it is not necessary to re-position the patient. If the area
of interest is not appropriately centered in the window, perform the following:
1. Release the compression device.
2. Reposition the patient.
3. Center the area of interest in the biopsy window.
4. Apply appropriate compression.
5. Lockout table controls.
Repeat the Single Image Acquisition sequence to ensure that the area of interest is
appropriately centered in the biopsy window.

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Acquiring Stereo Images

9.0 Acquiring Stereo Images

The Acquire Stereo image acquisition mode is used to obtain stereotactic images (±15°
projections) of a previously diagnosed suspicious area in the breast, and to determine its
exact position to aid in needle placement for stereotactic procedures. Acquire Stereo can
be conducted using one of two modes:
• Acquire Stereo 512 (512 x 512 pixel resolution)
• Acquire Stereo 1024 (1024 x 1024 pixel resolution)
The Acquire Stereo image sequence is launched by selecting one of the two choices from
the Main Menu (see Figure 7-8). The following paragraphs describe how to prepare the DSM
and the MultiCare Platinum for the exam, and presents an example sequence of operation
to acquire stereotactic images.
Before the Acquire Stereo image acquisition process begins, a single Image (Single) is
acquired (“Acquiring a Single Image” on page 114) to locate and position the region of
interest in the biopsy paddle window. Once the breast is positioned, do not remove the
patient’s breast from the device. Always conduct another single image exam whenever the
patient is re-positioned. Once the area of interest is confirmed, the stereotactic views can be
acquired. Never re-position the patient once the stereo acquisition sequence has begun.

Figure 7-8: Main Menu Acquire Stereo Selections

9.1 Choose the Stereo Image Acquisition Mode

Click Acquire Stereo 512 or 1024 to begin the sequence to acquire stereo pair images.

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Acquiring Stereo Images

9.2 Annotate the Image

After selecting the acquisition mode, the Annotation Dialog Box appears.
The Annotation dialog box prompts the user to enter unique information regarding the
patient and the ensuing exam. Patient information from the previous image remains. Enter
the compression information and any desired additional comments. For details on using the
Annotation dialog box, see Section 3.3.

Note… An entry must exist for Patient ID, Patient Name, Operator ID, Compression,
and Left or Right must be selected before the system will make an exposure.
The annotation process can be canceled at any time by clicking Cancel at the bottom of the
dialog box. This terminates the stereo image acquisition process and return to the Main
DSM screen.

9.3 The Image Acquisition/X-ray Technique Dialog Box

To continue with the exposure after completing the Annotation prompt, click OK. The
following dialog box appears:

Figure 7-9: Image Acquisition/X-ray Technique—512 Stereo Image Screen

The Acquisition dialog box displays a prompt informing the user that the DSM receptor is
waiting for the X-ray to begin. This indicates that the DSM is ready to capture an exposure.
Review the annotation information shown in the top portion of the dialog box for accuracy.
If the information is not correct, click Abort X-ray, or press the escape key to terminate the
image acquisition sequence, otherwise proceed with the image acquisition.

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Acquiring Stereo Images

9.4 Set the Exposure Techniques

To set the exposure techniques, use the X-ray Technique dialog box on the DSM screen
(Figure 7-5, p. 119). If Auto-Time was selected for the Scout Image, the Locked indicator
appears. If different exposure factors are desired, select manual mode.

9.5 Acquire the 1st Stereo Image Exposure

1. Move the C-arm to the +15° angle as instructed by the on-screen prompt.
2. Make final checks of the exposure factors and patient information.
3. Provide final instructions for the patient.

Note… Press and hold the X-ray button(s) until the exposure ends (tone stops).
If the X-ray button is released before X-ray exposure has started, the DSM
will continue to display the Waiting for X-ray dialog box. Press the Reset
button on the handheld console to clear the error, then click Ready X-ray
in the DSM Image Acquisition dialog box to reset the X-ray system to
Ready Mode. Re-take the exposure.
If the X-ray button is released after the X-ray exposure has started, the DSM
will acquire and display the image and return to Stand-by Mode just as it
does for a normal acquisition. Press the Reset button on the handheld
console to clear the error, then click to complete the image acquisition.
Select Retake in the Annotation Dialog Box to retake the exposure.
4. The DSM receptor captures the image, process the data, and then send it to the DSM
computer for display. The acquired image appears on the left side of the Active Image
Area, with the annotation information directly above it. The single Image (if taken) will
move from the left side to the right side of the Active Image Area. The Window/Level
window, which is a histogram that permits the user to adjust the contrast and
brightness of the image, appears below the first stereo image.

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Make Window/Level Adjustments

10.0 Make Window/Level Adjustments

Adjust the image contrast and brightness as necessary. Press the spacebar to invert the image.
Closing the Window/Level window by left-clicking displays the following dialog box:

Figure 7-10: Image Acquisition 512 Stereo Image

If the first Stereo Image is not acceptable for any reason, click Retake to restart the first stereo
image acquisition sequence. Click Abort X-ray to immediately cancel the stereo image
acquisition sequence.

11.0 Acquire the 2nd Stereo Image Exposure

1. Move the C-arm to the -15° angle indicated in the Image Acquisition dialog box.
2. If necessary, adjust the set exposure factors.
3. Provide final instructions for the patient.

Note… Press and hold the X-ray button(s) until the exposure ends (tone stops).
If the X-ray button is released before X-ray exposure has started, the DSM
will continue to display the Waiting for X-ray dialog box. Press the Reset
button on the handheld console to clear the error, then click Ready X-ray
in the DSM Image Acquisition dialog box to reset the X-ray system to
Ready Mode. Re-take the exposure.
If the X-ray button is released after the X-ray exposure has started, the DSM
acquires and displays the image and return to Stand-by Mode just as it
does for a normal acquisition. Press the Reset button on the handheld
console to clear the error, then click to complete the image acquisition.
Select Retake in the Annotation Dialog Box to retake the exposure.
• The acquired image appears on the left side of the Active Image Area, with the
annotation information directly above it. The first stereo image moves from the left
side to the right side of the Active Image Area. The Window/Level window appears
below the second stereo image.

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Make Window/Level Adjustments

12.0 Make Window/Level Adjustments

Adjust the image contrast and brightness as necessary. Press the spacebar to invert the image.
Closing the Window/Level window by left-clicking displays the following dialog box:

Figure 7-11: Image Acquisition—Stereo Acquisition Complete

If the second Stereo Image is not acceptable for any reason, click Retake to restart the second
stereo image acquisition sequence.

13.0 Stereo Targeting

Click Done to complete the stereo imaging acquisition process, and display the following
dialog box:

Figure 7-12: Stereo Targeting Dialog Box

The Stereo Targeting dialog box appears whenever the Active Image Window displays the
following stereo image pair types:
• ±15° projections (typical stereo pair)
• Right-side single image and left-side 15° projection (ScoutMarc right)
• Left-side single image and right-side 15° projection (ScoutMarc
left) The Stereo Targeting dialog box permits the user to:
• Initiate one or more stereotactic targeting sequences - Stereo Target.
• Start the Multi Pass sequence after a lesion is initially targeted.
• Send all the calculated coordinates to the Smart Window.
This dialog box also shows each of the coordinate sets (X, Y and Z coordinates) calculated
for the case shown on-screen. The DSM can calculate up to 6 coordinate sets and displays
them in columns (labeled A - F).

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Lesion Targeting Sequence

14.0 Lesion Targeting Sequence

The Lesion Targeting Sequence is used to determine the X, Y, and Z coordinates of the
lesion in the breast. This is done by marking the location of the lesion in the two views so
that the DSM’s coordinate calculation program can compute the exact horizontal (X),
vertical (Y), and depth (Z) positions. The DSM offers two methods to target the lesions.
• Stereo Targeting
• ScoutMarc Targeting
With Stereo Targeting, the user marks the lesion location in both views of the acquired
stereo pair (+15° and -15° views). The ScoutMarc Targeting method uses the previously
acquired single image (0° view) to replace either the left or right stereo image.

Warning: If the breast was re-positioned after the single image, the
ScoutMarc Targeting Sequence cannot be used without first
acquiring another 0° view.

Note… There is an increased error in the true Z axis when using ScoutMarc
(one image acquired at 0° and the other at 15°) as opposed to two
images at
+15° and -15°. The error margin may exceed 1 mm.
The following steps present an example sequence for targeting a lesion. If the user wishes
to use the Stereo Targeting sequence, leave the just acquired stereo pair in the Active
Image Window, then skip to “Begin the Targeting Sequence” on page 132. The ScoutMarc
Targeting sequence requires the user to set up the Active Image Window appropriately.

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Procedures Lesion Targeting

14.1 Select the Single Image for ScoutMarc Targeting

ScoutMarc is for targeting only.
1. Locate the single Image in the Case Study Area, (see “The Case Study List” on page 75)
— this must be the single Image immediately before the Stereo Pair.
2. Right-click the single Image thumbnail to open the drop-down menu.
3. Click ScoutMarc Left to display the image on the Left Active Image Window.
4. Click ScoutMarc Right to display the image on the Right Active Image Window.

Figure 7-13: Selecting ScoutMarc Targeting

The single Image appears in the selected Active Image Window, depending on the
ScoutMarc method selected (left or right). A new Stereo Pair appears in the Case Study
Area. At this time, the user can begin the targeting sequence described next.

Note… View On Left and View On Right is for display only.

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Lesion Targeting Sequence

14.2 Begin the Targeting Sequence

1. Ensure that the desired regions of interest is in the Active Image Window.
2. Click Stereo Target from the Stereo Targeting Dialog Box,Figure 7-12.
The DSM requires that the images of the reference points (above the biopsy window) be
accurately marked to precisely calculate the lesion coordinates.
When the targeting sequence is initiated, the following dialog box appears:

Figure 7-14: Reference Cursors Positioned Correctly? Dialog Box

Locate the images of the reference point above each image and determine if the targeting
mark is accurately positioned on it (see Figure 7-15). If both marks are directly on the
reference point images, click Yes and continue to “Mark the Lesion in the 1st Image” on
page 134.
• If either mark is not positioned correctly, click No.

Figure 7-15: Reference Point Cursor Placement Example

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14.3 Mark Reference Cursors

If reference cursors are not seen:
1. Enlarge Mag window to largest size by clicking right button.
2. Move the Mag Window over left reference image, then click to place.
3. Move the Mag Window over right reference image, then click to place.

Note… The operator may change the brightness of the Mag Window data while
the Mag Window is being positioned. The number pad “+” or “-” keys may
be used to increase or decrease the image intensity while the Mag
Window is being positioned.
4. Move the target symbol onto the left reference image, then click to display the
guideline on the right image.
5. Right click to display the drop down menu.
6. Select Window-Level, Change Window Level, to view reference point.
7. Precisely position the targeting symbol on the reference point image, then click to mark.
8. Precisely position targeting symbol on the opposite side of the reference point
image, then click to mark (see Figure 7-16).

Figure 7-16: Marking the Reference Cursors

When the sequence for marking the reference cursors is done, or when Yes is selected from
the Are Reference Cursors Positioned Correctly? dialog box, the lesion targeting sequence
begins. The user can right-click in either image to show the Image Enhancement drop-down
menu, and modify the images as needed.

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Lesion Targeting Sequence

14.4 Mark the Lesion in the 1st Image

1. Roll the trackball to position the Targeting Symbol over the lesion in either image
(see Figure 7-17).
2. Left-click to display the Locus Line (reference line) on the opposite image.
3. Move the Targeting Symbol precisely onto the lesion or region of interest by using the
trackball or arrow keys.
4. Left-click again to mark the lesion.
The user can change the type of Targeting Symbol used to mark the lesion. By default, the
symbol appears as a box. Right-click in either image during the targeting sequence, click
Stereo, then click Change Cursors to view the Targeting Symbol as a crosshair. Repeat this
to change it back to a box. An alternate method: press the spacebar on the keyboard.
To hide the Locus Line (reference line) when it appears during the targeting sequence, right-
click in either image, click Stereo, then click Hide Locus Line. To view the line again,
repeat the procedure. An alternate method: press Insert or Delete keys to Hide/Show Locus
Line.
To abort the targeting sequence anytime, right-click in either image, click Stereo, then click
Abort Targeting. An alternate method: press the Esc key on the keyboard.

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14.5 Mark the Lesion in the 2nd Image

1. Move the Targeting Symbol along Locus Line to lesion area in second image.
2. Precisely move the symbol over the lesion or region of interest that closely matches
the first target by using the trackball or arrow keys.
3. Click to mark the lesion.

Note… The DSM limits the distance the user is allowed to move the Targeting
Symbol away from the Locus Line (reference line) to ensure target
marking is accurate.

Figure 7-17: Lesion Targeting

The lesion coordinates (X, Y, and Z values) will appear in the Stereo Targeting dialog box
under column “A”.

Note… If the ScoutMarc method was used to target the lesion, the DSM
creates another stereo pair and displays it in the Case Study Area.
The user can calculate up to 5 additional target coordinates by clicking Stereo Target, then
following the targeting sequence (see “Multiple Targets” on page 136), or up to 5 additional
passes of the initial target (same Z depth) by clicking Multi Pass, then following the
targeting sequence (see “Multiple Passes” on page 137 later in this chapter).

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Multiple Targets

14.6 Transmit the Coordinates to the Smart Window Display

1. Click Transmit on the Stereo Targeting dialog box.
2. Ensure that all of the coordinate sets are sent to the window display.
3. Perform the biopsy procedure by following the clinical sequence for the device at your
site.
4. To erase a coordinate set from the Stereo Targeting dialog box, right-click the coordinate
set to erase, then click Erase Target. To erase all the targets shown, right-click in the
dialog box, then click Erase All Targets. Targets are erased from the Smart Window
whenever a new patient is selected.
The user can hide all the marking symbols in the image pair after the targeting sequence
by right-clicking in the Stereo Targeting dialog box, then clicking Hide Stereo Cursors. To
view them again, right-click in the dialog box, then click Show Stereo Cursors.
The user can also recall the last set of coordinates that were transmitted to the Stage by right-
clicking in the Stereo Targeting dialog box, then click View Stage Cursors. The DSM recalls
the last set of coordinates transmitted and display them in the Stereo Targeting dialog box. To
return the display to the current set of coordinates, right-click in the dialog box, then click
Hide Stage Cursors.

Note… If targeting was performed on a ScoutMarc Stereo, View Stage cursors

are not displayed.

15.0 Multiple Targets

The Multiple Target option allows the user to target up to five additional areas of interest
in the same stereo pair (or ScoutMarc pair). This feature allows for multiple area sampling
using new coordinate sets (X, Y, and Z) for each sample.
To obtain multiple target coordinates in addition to the initial set (column A), click Stereo
Target in the Stereo Targeting dialog box. The procedure for marking additional targets is
the same as when marking the initial target. When the sequence is complete, the second
coordinate set appears in the Stereo Targeting dialog box (column B). This process is
repeated for subsequent targets (up to five additional coordinate sets).

Note… The appropriate set of cursors in the image pair spin for about 1
second whenever the user moves the pointer over the corresponding
set of coordinates in the Stereo Target dialog box.
If it is necessary to re-mark the reference point images before starting the Multiple
Targeting sequence, right-click in the Stereo Targeting dialog box, then click Reference
Cursors. The sequence for marking the reference cursors is the same as during the initial
targeting sequence.

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Multiple Passes

16.0 Multiple Passes

The Multiple Pass option allows the user to target up to five additional areas surrounding
the previously targeted lesion. This feature allows for multiple samples of a lesion using the
same depth (Z-coordinate).
To obtain multiple pass coordinates in addition to the initial coordinate set (column A),
click Multi Pass in the Stereo Targeting dialog box. Targeting Cursors are placed on LT and
RT images simultaneously. When the sequence is complete, the second coordinate set
appears in the Stereo Targeting dialog box (column B). This process is repeated for
subsequent targets (up to five additional coordinate sets). Note that the Z-value for each set
remains the same.

Note… The appropriate set of cursors in the image pair spin for about 1
second whenever the user moves the pointer over the corresponding
set of coordinates in the Stereo Target dialog box.
If it is necessary to re-mark the reference point images before starting the Multiple
Targeting sequence, right click in the Stereo Targeting dialog box, then click Reference
Cursors. The sequence for marking the reference cursors is the same as during the initial
targeting sequence.

Note… In MultiPass mode, the right cursor appears as a caution icon if you
attempt to target a point beyond the image boundaries.

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Chapter 8—Quality Assurance
System Preparation

Chapter 8—Quality Assurance

Quality Assurance is accomplished by means of QAS test procedures to ensure accurate

alignment and performance when the DSM is used with the MultiCare Platinum Biopsy
System. By means of the Quality Assurance Needle provided with the MultiCare Platinum, a
mock lesion on the needle tip is localized through the verification test sequence. The test
includes:
• Biopsy device and stage setup
• Acquiring a stereo pair
• Determining and verifying lesion coordinates
Results from this test are compared with the X, Y, and Z coordinates on the biopsy device
stage display to confirm system performance.

1.0 System Preparation

1.1 System Preparation
Required tools:
• QAS Needle
• QAS Needle Holder
• Air Phantom
• 14 gauge non sterile needle guides (2)
• Tape

1.2 Image Setup

1. Turn on the DSM computer and Generator.
2. Log in to access Main Menu.
3. Set Manual technique of 8.0 mAs @ 28 kVp.
4. Acquire STEREO 512 mode.
5. Enter proper annotation.
6. Select "OK" or press "Enter". "Set C-arm to + 15 and Take X-Ray" on DSM and "Ready" on
generator should be indicated.

Note… At startup, the CCD chip in the digital receptor requires 10 minutes to reach
its operating temperature. During this cool-down period, X-Ray exposures
are not permitted.

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QAS Needle Test

1.3 Compression Accuracy Test

1. Set Breast platform tray at 4.5 cm
2. Using the hand wheel knob for compression, advance the biopsy compression paddle
until the paddle touches the breast platform.

Note… Do Not Force the Paddle onto the Platform!

3. Compression amount will show on the window display under compression in mm.
Compression amount should register 0.0mm ±1.0mm.

Note… When performing the compression test, ensure that the compression
amount decreases as the compression paddle is moved toward the image
receptor, and increases as the compression paddle is moved away from
the image receptor.

2.0 QAS Needle Test

1. Install and lock Biopsy Compression Paddle.
2. Move the Breast Platform to 4.5 cm.
3. Install the Needle Guide Mount onto the Z axis of the stage and position the Needle
Guides and QAS Needle. Tape the hub of the QAS Needle so that it rests securely
against the rear needle guide.
4. Compress the air phantom to 45- 50 mm using motorized compression.
5. Press MOTOR ENABLE and Z POSITION keys simultaneously until an audible beep is
heard.
6. Rotate the manual Y axis control knob until the QAS Needle is at the level of the
reference hole. Verify that Stage line in Smart Window reads 0.0 on X and Y.
7. Slowly move the QAS Needle toward the Compression Paddle until the needle tip just
touches the reference hole. Press the Z ZERO key until an audible beep is heard.
8. Move the needle back away from the Compression Paddle using Z dial, then down on
the Y-axis until the needle tip is within the biopsy window.
9. Advance the Z dial to read 0.5 on the Z Stage line. Press the Z ZERO key until an
audible beep is heard.
10. Rotate the manual X, Y and Z control knobs to set Stage line to read x= +10, Y= +20 and
Z= +30. Ensure that the front needle guide is advanced completely toward Compression
Paddle.
11. Move the C-arm to the + 15 degree position.
12. Take the exposure.
13. Adjust Window/Level as needed.
14. Left click to save.
15. Move the C-arm to the -15 degree position.
16. Take the exposure.
17. Adjust the Window/Level as needed.
18. Click to save and click "DONE".
19. Click on "STEREO TARGET" to begin the coordinate calculation sequence.

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20. Ensure that the Reference Cursors are positioned over the reference hole in both views. If
they are positioned properly, select “YES”. If not, select “NO” and correct position of
reference cursors.
21. Move the targeting symbol over the center of the needle tip in the Left image. The
mag feature may be selected to aid in visualizing the needle tip. Click left to bring the
Locus line into the Right image. Click left to place target in Left image.
22. Move the targeting symbol over the center of the needle tip in the Right image. Click left
to place.
23. Confirm that coordinates in Target Column A are ± 1.0 mm of x= + 10, y= +20 and Z=
+30.
24. Select "TRANSMIT" and verify coordinate transmission by checking "PASS A" line
in Smart Window.
25. If coordinates are not within ± 1.0 mm, check the following:
• X error-check the position of the Compression Paddle
• Y error---check that the front needle guide is all the way forward to the Compression
Paddle
• Z error---check that the hub of the QAS Needle rests securely against the rear
needle guide
• Repeat QAS Test. If coordinates are still not within ± 1.0 mm, call Field Service.

3.0 Mammography Phantom Test

ACR (American College of Radiology) requirements specify visualization of the fibers,
calcification (speck) groups, and masses in an accredited stereotactic phantom (Ref. ACR
Stereotactic Breast Biopsy Quality Control Manual).

3.1 Mammography Test Setup

1. Move the breast platform to the 4.5 cm position.
2. Place the evaluation phantom on the breast platform and place it under the
Biopsy Compression Paddle to hold it in place.
3. Set the unit to make an exposure at 28 kV, Auto-Time mode (to obtain a histogram
value of 4k).

Note… These recommended exposure factors are a nominal starting point.

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3.2 Fiber Test

The DSM image must clearly show the 5th fiber (mammographic phantom) or the 3rd fiber
(mini-phantom)
1. Position the phantom so that the evaluation objects (fibers) are positioned within
the biopsy window.
2. Click Acquire 512 from the DSM Main Menu.
3. Annotate the image as an Evaluation Fiber Test - 512, then make the exposure.
4. Process the image as necessary to evaluate the image.
5. Repeat this test for the 1024 mode.
6. Annotate the image as an Evaluation Fiber Test - 1024.

Note… If the evaluation fails for either mode, check for correct exposure factors,
and for proper phantom positioning in the biopsy window.

3.3 Calcification (Speck Group) Test

1. Move the phantom so that the evaluation objects (speck groups) are beneath the
biopsy window (not required for mini phantom).
2. Click Acquire 512.
3. Annotate it as an Evaluation Speck Test - 512.
4. Make the exposure.
5. Process the image as necessary to evaluate the image.
6. Repeat this test for 1024 mode.
7. Annotate the image as an Evaluation Speck Test - 1024.
The DSM image must clearly show the 4th speck group (mammographic phantom), or the
3rd speck group (mini phantom).

Note… If the evaluation fails for either mode, check for correct exposure factors,
and for proper phantom positioning in the biopsy window.

3.4 Masses Test

The DSM image must clearly show 3.5 masses (mammographic phantom) or 2.5 masses
(mini phantom).
1. Move the phantom so that the evaluation objects (masses) are beneath the
biopsy window.
2. Click Acquire 512.
3. Annotate it as an Evaluation Mass Test - 512.
4. Make the exposure.
5. Process the image as necessary to evaluate the image.
6. Repeat this test for 1024 mode.
7. Annotate the image as an Evaluation Mass Test - 1024.

Note.… If the evaluation fails for either mode, check for correct exposure factors,
and for proper phantom positioning in the biopsy window.

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MAMMOGRAPHIC PHANTOM MINI PHANTOM

(not-to-scale)
(not-to-scale)

Minimum Score: Fiber : 3 fibers

Speck : 3 groups
Mass : 2.5 masses

Minimum Score: Fiber : 5 fibers

Speck : 4 groups
Mass : 3.5 masses

Figure 8-1: The RMI 156 Phantom

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3.5 Quality Control Test for DSM

(Modified from the ACR Stereotactic Breast Biopsy QC Manual)
Frequency
This test should be performed annually by the medical physicist responsible for MQSA
evaluations of mammography equipment. In addition, this test should be performed
whenever major changes are made in the imaging chain such as replacement of the X-ray
tube, changes of the X-ray tube filter, etc., or whenever the image field uniformity appears
inadequate.
Test Procedure
1. Remove the compression paddle from the equipment.
2. Ensure that the breast platform on the MultiCare Platinum table is located in the 6
cm position closest to the digital image receptor.
3. Place the acrylic or BR-12 as close to the image receptor as possible and ensure that
the image receptor is completely covered.
4. Obtain a digital image with the uniform 4 cm thick sheet of acrylic or BR-12 material
covering the entire image field, with the 1024 x 1024 acquisition mode at 28 kV,
manual mode, large focal spot. (about 1.0 second.)
5. Adjust the mAs or time to obtain a mean signal level of approximately 4,000. (The peak
of the histogram should be at approximately 4,000.)
6. Use the trackball to select File (upper left of screen).
7. From the File menu, select Image Statistics to obtain the Region of Interest (ROI)
and Image Statistics box.
8. Press the right trackball button to change the size of the ROI to 32 x 32. (The size
is shown at the upper right corner of the Statistics box.)
9. Position the ROI, using the trackball and the left and right arrow keys, to the center of the
screen. The center of the ROI should be at (512, 512).
10. Record the signal (or Average Pixel Value, shown as “Ave” in the Image
Statistics window).
11. Position the center of the ROI subsequently at the following coordinate locations: (200,
200), (800, 200), (200, 800), and (800, 800). Record the signal at each of the locations.
Recommended Performance Criterion and Corrective Action
The signal measured in each corner of the image should be within ± 15% of the signal
measured at the center of the field of view on a properly calibrated digital system. If the
signal does not meet this performance criterion, contact a service engineer authorized to
service Hologic equipment for assistance.
Precautions and Caveats
Artifacts in the acrylic block or BR-12 may significantly affect the signal value if they are
included in the ROI. Artifacts can be detected by viewing the image at a very narrow
window width. If artifacts are in the ROI, then the ROI should be moved slightly to avoid
the artifacts or the measurements should be made on another image with the block in a
different orientation, e.g., rotated 90º.

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Chapter 8—Quality Assurance

4.0 Quality Control Using the SMPTE Test Pattern

The SMPTE test pattern (Figure 8-2) was developed by the Society of Motion Picture and
Television Engineers as a standard test pattern for the set-up and quality control of displays
and hard-copy (film) imaging devices. It can be used to evaluate the following
characteristics:
• Appropriate display brightness and contrast settings
• Appropriate film density and contrast
• Brightness or density linearity
• High contrast resolution
• Low contrast resolution
• Spatial linearity
• Uniformity and artifacts
• Display of all information in the test pattern
• Sharpness of image elements
• White and black window distortion

4.1 SMPTE Test Pattern Usage

The MultiCare Platinum has two SMPTE test patterns, 512 and 1024.
• The 512 test pattern is recommended for setting up the display.
• The 1024 test pattern is recommended for setting the printer. View the 1024 test pattern
using the Zoom-In option.

Figure 8-2: SMPTE Test Pattern

Note… The test patches are not distinct in this figure due to the limitations of the
printing process.

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Operator’s
Chapter 8—Quality Assurance
Quality Control Using the SMPTE Test Pattern

4.2 Display Brightness and Contrast Settings

The brightness and contrast settings can be optimized using the two smaller square patches
which are inset into the 0% and 100% patches in the gray scale (see Figure 8-3.) The inset
patches are at 5% and 95% of the gray scale so they are 5% above pure black and 5%
below pure white. If these two inset patches are visible then one can be sure that all
information in the digital image is displayed appropriately.

Figure 8-3: 5% and 95% Inset Test Patches.

Note… The inset test patches should appear similar to those shown here on
both the display and hardcopy images.

Note… The display brightness and contrast should be checked monthly.

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4.3 Procedure—Optimizing Display Brightness and Contrast

1. Open the Directory List and display the SMPTE test pattern by double clicking on the
image entitled SMPTE in the patient image file.
2. Right-click over the SMPTE image and select Filter from the sub-menu; ensure that the
image is unfiltered. The only check mark should appear next to “Original Image”
(Figure 8-4, p. 147).

Figure 8-4: Filter Settings —SMPTE Test Pattern

3. Right-click over the SMPTE image and select Zoom-In.

4. Ensure that the window width and level are set at 16384 and 8191, respectively. This
can be accomplished by displaying the histogram and the window and level. Right click,
select window and level and left click. The F1 function key toggles the window and
level numeric display on and off. If the window and level are not 16384 and 8191,
respectively, use the arrow keys to obtain these values.
5. Adjust only the brightness control on the monitor until the area outside of the image
(black area on the display) and the 0% patch is just slightly gray, as opposed to
absolute black.
6. Adjust only the contrast control so that the 95% patch can be clearly seen.
7. Adjust only the brightness control so that the 5% patch can be clearly seen.
8. Check to see that the text and numbers on the test pattern are clear and sharp. If they are
not clear or they are smeared to the right, readjust the contrast control until they are
sharp.
The display is now optimized. The brightness and contrast controls should not be adjusted
in the future without the use of the SMPTE test pattern and the Procedure described above.
If the brightness or contrast of the clinical images appears incorrect, then it is necessary to
adjust the window and level to provide optimum clinical images on the display.

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Chapter 8—Quality Assurance
Quality Control Using the SMPTE Test Pattern

4.3.1 Adjusting Monitor Brightness and Contrast

Note… Monitor must be in Normal Mode to adjust brightness and contrast settings.
To change Display Mode:
1. Press the control knob on the right side of the monitor.
2. Display Mode (bottom line of dialog box) should read Normal Mode. If not:
a. Turn the control knob to highlight Display Mode, and press the button.
b. Select Normal Mode, press button
c. Exit twice. The menu should say Normal Mode. You may now adjust
brightness and contrast settings.
To adjust Monitor Brightness and Contrast:
1. Press the control knob on the right side of the monitor. The Menu is displayed.
2. Turn the wheel to select brightness, and press the button.
3. Use the wheel to adjust Brightness.
4. Press the button to accept the settings.
Contrast can adjusted by using the same
steps.
A good nominal starting point is brightness 65, contrast 80.

4.4 Procedure—Optimizing Hardcopy Image Density and Contrast

Note… Prior to performing this test, verify film printer and film processor are
calibrated.
1. Open the Directory List and display the SMPTE test pattern by double-clicking on the
image titled “SMTPE” in the patient image file.
2. Right-click the image, select Window/Level, and left-click. Press the F1 function key to
toggle the Window and Level numeric display to ON. Ensure that the window width and
level are at 16384 and 8191 respectively. If they are different, adjust them to the
above values and save the image by right-clicking on the image and left-click Save
Image.
3. Open the File Manager and select “SMPTE” from the list. Click “Print File” and select
“High (1024)” resolution. Click “OK” to expose the SMPTE test pattern on either film or
a paper printer.
4. Visually inspect the 5% and 95% patches and ensure that they can be seen clearly. If
they are not seen clearly, it will be necessary to adjust the controls of the printer so that
they are visible.
5. Ensure that the alpha numerics are sharp. If not, readjust the printer so that the alpha
numerics are sharp and the 5% and 95% patches are clearly seen.

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Chapter 8—Quality Assurance

4.5 Hardcopy Output Quality Test (Digital Only)

4.5.1 Objective
To ensure that the quality of hardcopy output is consistent over time and matches
the grayscales presented on the CRT monitor.

4.5.2 Frequency
This test, or a similar test specifically recommended by the hardcopy equipment
manufacturer, should be carried out at least monthly.

4.5.3 Required Test Equipment

• Densitometer
• SMPTE (Society of Motion Picture and Television Engineers) Test pattern, or
another, similar test pattern or phantom image having a wide range of grayscales
(The same test image should be used each time.)

4.5.4 Procedure
1. Display the SMPTE test pattern or phantom image on the monitor with
grayscales ranging from white to black and a reasonable range of grayscales in
between.
2. Record the window width and window level settings used to display the image;
the same window width and level settings should be used for each subsequent
display and printed image.
3. Print the image on film.
4. Process the film.
5. View the recorded film image on an appropriately masked view box next to the
monitor.
6. Measure the optical density at four consistent locations on the film and record.
7. Compare all optical density measurements to those from the previous month's
image.

4.5.5 Data Analysis and Interpretation

1. Visually compare grayscales on the film and monitors using the same window
width and window level settings as used to produce the film.
2. The first time this procedure is performed and there is consistency between
the monitor and film, record these window width and window level values and
measured optical density film values on the chart as your control level.

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Chapter 8—Quality Assurance
Quality Control Using the SMPTE Test Pattern

4.5.6 Recommended Performance Criteria and Corrective Action

The image on the film should not be lighter or darker than the image displayed on
the monitor when viewed with the same window width and level, settings used for
printing. If there are significant differences, the contrast and brightness of the
monitor should first be checked by the medical physicist or service engineer. If the
monitor was correctly set-up according to manufacturer's instructions, then contact
the appropriate service engineer for adjustment of the hardcopy output device.
If optical densities measured at the four locations differ by more than 0.20 from
the control level values, check that the same window width and level settings have
been used as were used to establish control levels. If differences persist, repeat the
test. If the optical density differences in the repeated test differ from control levels
by more than 0.20, then contact the service engineer for adjustment of the
hardcopy output device. A drop in film optical densities may be due to film
emulsion differences from batch to batch or processing chemistry changes. If the
processing chemistry is used infrequently and the fIlm emulsion batch has not
changed, a decrease in optical density is likely to be due to developer oxidation. In
such cases, the developer chemistry should be changed to fresh chemistry with
starter.

4.6 Other Image Quality Checks

The following describes other image quality checks for displays and hardcopy images

4.6.1 High Contrast Resolution

The high contrast resolution is evaluated by observing the high contrast (black and
white) test patterns located in the center and the four corners of the SMPTE test
pattern. The vertical and horizontal lines in the test pattern should appear the same,
i.e., black and white. Likewise, compare the test patterns in the center of the image
to those in the corners. If there is a significant difference in the appearance between
the vertical and horizontal lines, or between the center and corners, a service
engineer should evaluate the system.

4.6.2 Low Contrast Resolution

The low contrast resolution is evaluated by observing the low contrast (gray) test
patterns located in the center and the four corners of the SMPTE test pattern.
These test patterns are at 1%, 3%, and 5% contrast. All test patterns should be
visible, when a window width and level of 16384 and 8191, respectively, are used.
If any of the low contrast test patterns can not be seen after adjusting monitor
brightness and contrast, a service engineer should evaluate the system.

4.6.3 Spatial Linearity

Spatial linearity is evaluated with the fine line grid pattern over the entire image. The
lines, in both directions, should appear straight and well defined.

4.6.4 Uniformity and Artifacts

Uniformity and artifacts can be evaluated by visually measuring monitor luminance
or film density, and visually inspecting the uniform background of the test pattern.

4.6.5 Display of All Information

It is important to ensure that all of the information in the image is being shown on
the display and hardcopy image. This can be accomplished by viewing the dual
border around the outside of the SMPTE test pattern.

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Chapter 9—Care and Maintenance
Introduction

Chapter 9—Care and Maintenance

1.0 Introduction
This Chapter describes the prescribed cleaning and disinfection methods for the MultiCare
Platinum System. Handle accessories carefully, and inspect them frequently.

2.0 Care and Cleaning

2.1 Cleaning and Disinfection
All parts of the unit which come in contact with the patient must be cleaned and
disinfected prior to each procedure. The standard hospital regimen for disinfection should
be followed, with the following qualifications:
• Do not clean with solvent-based cleaners containing benzene or stain removers.
• Do not use extra strength or abrasive cleaners, polishes, or waxes.
Proprietary disinfection solutions meeting the above limitations are suitable, provided that
the manufacturer’s instructions are stringently followed.
As a general rule, disinfectant sprays may not be used directly, since the mist generated by
spraying may penetrate into units, which may damage electronic components. To use a
disinfectant agent in spray form, first apply the agent to a cloth or pad, then use the pad to
apply the agent to the surface requiring disinfectant.

2.2 Cleaning Solution Recommendations

For general cleaning, use a lint-free cloth dampened with water or a lukewarm, diluted,
aqueous solution of household dishwashing liquid.
The following cleaning solutions have been found to be compatible with polycarbonate
accessories:
• 10% chlorine bleach and water solution
• 70% (by volume) isopropyl solution
• 90% maximum concentration of Hydrogen Peroxide solution

Note… After cleaning or disinfecting with any of the above solutions,

the components must be washed with soap and warm water.

2.3 Care of Plastic Components

Handle the plastic components (Compression Paddles) carefully, and inspect them
frequently. If they begin to crack, replace them promptly, before they become unusable or
dangerous.
Clean acrylic surfaces on parts such as cassette holders with one of the recommended
solutions. To disinfect acrylic surfaces, use normal hospital disinfection procedures.

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Chapter 9—Care and Maintenance
System Performance Checks

2.4 MultiCare Platinum Patient Table

Two layers of Naugahyde surrounding a foam pad make up the Padded Table Cover. This
cover is attached to the painted steel Table surface by strips of Velcro around its outer
edges making removal easy. ALWAYS disinfect the top surface of the cover after each
procedure. If necessary, lift the cover off the Table to clean and disinfect the bottom side
of the cover and the steel surface of the Table.

2.5 MultiCare Platinum and DSM Console

Under normal use conditions, wipe the MultiCare Platinum Table and DSM Console once
a day with a slightly damp cloth. If stains persist, use a cloth lightly moistened with a
solution of warm water and a mild detergent solution.
Clean the surfaces of the following items according to the cleaning solution
recommendations outlined previously:
• Table Control Panel Push buttons—keep covered at all times. See Figure 7-6, p. 121.
• DSM Console
• CRT Screen
• Radiation shield
Avoid spilling water or dripping wet cloths, tissues, or sponges when cleaning the MultiCare
Platinum System as this may damage electronic components.

3.0 System Performance Checks

Each day, prior to using the MultiCare Platinum, perform the Quality Assurance Tests
(described in Chapter 8—Quality Assurance) to ensure proper alignment of the biopsy
paddle and X-ray tube.
Once a week, with the exception of the X-ray button, check the DSM functions by modifying
all user-selectable options. Operate all of the controls on the MultiCare Platinum Control
Panels and verify proper responses (see Chapter 2, Section 9.0,The DSM System Controls
and Display, p. 20 and Chapter 3—Using the Handheld Console). Maintain permanent
records with dated signatures to document the control function checks.
If the system does not perform as expected, review the set up, connection, and installation
information in Chapters One through Seven of this manual to ensure the system setup is
correct, and that the proper controls are being used in the correct sequence. If, after referring
to the appropriate section of this manual, a problem persists, contact your authorized service
dealer.

Warning: It is the responsibility of the user to correct anomalies or abnormal

operation of the MultiCare Platinum unit before use, and to arrange
for preventive maintenance twice a year by authorized personnel.

The X-ray tube should be inspected once a year by qualified service engineer for leakage,
abnormal noise, or vibration. The ground connections and high-voltage connections should
also be checked.

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Appendix A—

Appendix A—Specifications

1.0 MultiCare Platinum Table and Generator Specifications

The following section details the MultiCare Platinum Table, and Generator specifications,
including performance and environmental specifications.

1.1 System Performance

Tube Potential: 22 kVp - 34 kVp in 1 kV increments,
constant potential
Tube Current: 80 mA at 22kVp - 28kVp
70 mA at 29kVp - 34kVp
Focal Spot: 0.25 mm square - nominal
Regulation Statement: Constant potential output maintains specified
kV and mAs accuracy through the nominal
input range.
SID: 88 centimeters - DSM Receptor
Exposure Mode: User selects Manual or Auto-Time Mode
Exposure Technique Control: User selects kV and mAs (Manual Mode
only)
values
C-Arm Rotation Angle: 0° to 180° continuously variable
Stereo Angle: ±15°
Coordinate Measurement Device: Digital Spot Mammography System
(DSM) Beam Limiting: Interchangeable Apertures

Beam Indication: Permanent marking

1.2 Mechanical Specifications

Table Type: Bi-directional; access required to only
one side
Table Surface Measurement:
Height: 86.4 cm (34") to 145 cm (57")
Size: 183 cm (72") L, 71 cm (28") W
43 cm (17") leg support extensions on either
side
Work Area Light: 2 adjustable Halogen lamps mounted on C-
arm, aperture lighting
C-Arm Motion: Longitudinal: ±12.7 cm (±5”
Transverse: ±12.7 cm (±5”)
Independent Vertical C-arm Movement 5” ± 1”
Table Aperture Diameter: 25.4 cm (10”)
Localization Accuracy: ±1 millimeter
Maximum Patient Weight: 136.1 kg (300 lb)

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Appendix A—Specifications
MultiCare Platinum Table and Generator

1.3 MultiCare Table and Generator Dimensions

Figure A-1: MultiCare Platinum Table and Generator Dimensions

1.4 Compression
Biopsy Window Opening: 5.6 cm x 5.6 cm
Pre-Compression: Motorized Up/Down
Full Compression: Manual, Handwheel driven
Compression Release: Manual Only
Compression Controls: Controlled by keypads on MultiCare Platinum
Control Panel, or by dual pedal footswitch
Motorized Compression Force: 30 lb. ±3 lb.

Motorized Compression Speed: 1 inch per

second

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Appendix A—

1.5 Generator
Output Rating: 2.38 kW (70 mA at 34 kV) max
Ripple: Not greater than 4% peak-to-peak
mAs Range: 3-400 mAs
Electrical Interface Mains Voltage: 200/208/220/230/240 VAC ±10%, 50/60 Hz
Hard-wired
Impedance: Not greater than 0.2 Ohms at 200 VAC input.
Not to exceed 0.25 Ohms at all other input
voltages.
Power Consumption: 7.0 kVA for 5 seconds (max.)
Standby Current: 4 Amps maximum
Maximum Line Current: 35 Amps, 5 seconds
Circuit Breaker Rating: 25 Amps—time delay curve to allow for
inrush currents, 200% overload for 7
seconds. (Requires 35 A in-house fuse for
ROW installation.)
Duty Cycle: 50% max; intermittent use
Dimensions: 38 cm (15”) W x 64 cm (25”) L
x 51 cm (20”) H

1.6 Shielding Specifications

Operator: Radiation Shield (customer supplied) must
be positioned between Patient Table and
Handheld Console
Patient: The Patient Table provides the necessary
shielding for radiation protection

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Appendix A—Specifications
MultiCare Platinum Table and Generator

1.7 X-ray Tube Specifications

Manufacturer/Model: Varian Eimac (M-149 Insert, B-110 Housing)
Target Material: Molybdenum
Diameter: 3.1 inches
Window Material: Beryllium
Maximum Ratings:
Tube Potential: 39kV
Tube Current: 80mA
Leakage Technique Factor: 4.0 mA @ 39kV
Anode Ratings:
Rotation: 60Hz, 3600 rpm
Angle: 10°
Heat Capacity: 300,000 heat units
Over-Temp. Protection: Internal sensor opens at 175°F. (80°C.)
Internal sensor closes at 140°F. (60°C.)
Heat Dissipation: 60,000 HU/min. (max)
Permanent Filtration: 30 microns Mo (minimum)
Tube Cooling: The MultiCare Platinum System automatically
computes and adjusts anode current
according to the manually selected kV. A 30
second standby interval is imposed between
successive exposures. These control
provisions limit heat accumulation in the X-
ray tube and housing. Heat storage and
temperatures remain well below the
maximum values
derived from tube rating and cooling curves.

1.8 Environmental
Maximum Altitude: 8,000 feet (2.4 kilometers) above sea level
Operating:
Temperature Range: 10 to 35° C
Relative Humidity Range: 20 to 80%, non-condensing
Storage:
Temperature Range: -9.4 to +70° C
Relative Humidity Range: 0 to 95%, non-condensing. (not for outdoor
storage)

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Appendix A—

1.9 Technique Accuracy

kV: The actual value will not differ by more than
±1 kV from the indicated value.
mAs: ±5% or ±2 mAs, whichever is greater, from
indicated, measured on the ground side of
the tube circuit.
mA: Actual value will not differ by more than ±5%
from the indicated value.

2.0 DSM Specifications

2.1 System Features
Tissue Imaging Area: 5.5 cm x 5.5 cm @ Breast Platform (@ 4.5cm
Platform Offset on MultiCare Platinum)
Near real-time image display: 512 mode - approximately 5 seconds
1024 mode - approximately 8 seconds
Acquisition Modes: Choice of 512 or 1024 pixel resolution:
512 x 512 pixels (High Sensitivity)
1024 x 1024 pixels (High Resolution)
Image Manipulation Functions: Window/Level (Contrast, Luminance), Invert
Gray Scale, Zoom, Mag Box, Various
Image Filtering functions, Measuring Tools

2.2 Digital Image Receptor

Dimensions: 32.1 cm (12.625") W x 27.9 cm (11") H x 12.7
cm (5") D
Weight: 11.3 kg (25 lb)
Actual Image Area: 6.8 cm x 6.8 cm at Phosphor screen
Image Device: Charge-Coupled Device (CCD)
Pixel Count: 1024 (H) x 1024 (V)
Pixel Size: 24 µm (H) x 24 µm (V)
Digitizing Resolution: 14 bit data
Dark Field Read Noise: <25 electrons RMS
CCD Operating Temp: -23° C (CCD cooled to reduce noise)
Exposure Time: 0.1 - 5.0 seconds

Synchronization: Interlocked with X-ray control signal

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Appendix A—Specifications
DSM Specifications

2.3 DSM Cart Dimensions

Dimensions: 91.4 cm (36") W x 96.5 cm (38") H x 71.1 cm
(28") D
Weight 114.8 kg (253 lb)—complete system

Figure A-2: DSM Cart Dimensions

2.4 DSM Workstation Dimensions

Dimensions: 86.4 cm (34") W x 133 cm (52") H x 71.1 cm
(28") D
Weight: 77.1 kg (170 lb)—complete system

Figure A-3: DSM Workstation Dimensions

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Appendix A—

2.5 DSM Computer Dimensions

Dimensions: 19.1 cm (7.5") W x 42.5 cm (16.75") H x 43.2
cm (17") D
Weight: 11.3 kg (25 lb approximate (CPU, keyboard,
trackball)
Microprocessor: Intel CPU

Archive Media: DVD/ CD RW

2.6 DSM Monitor Specifications

Type: Flat Panel: 46 cm (18.1”) monochrome LCD
Dimensions:
Height: 48.3 cm (19”) with Tilt Swivel Base
Width: 43.2 cm (17”)
Depth: 25.1 cm (10”)
Net Weight: 9.4 kg (21 lb)
Power Supply:
Power Consumption: 100 Watts (nominal)
Input Voltage: 90 to 130 VAC, 220 to 250 VAC
Input Frequency: 47 – 63 Hz
User Controls: Brightness, Contrast
Video Bandwidth: 200 MHz @ -3db
Input Signals:
Analog: 3 BNC (Auto Selection of
Syncs) EIA RS-343-A Standard
Resolution: 1280x1024 (minimum)
Brightness: 700 cd/m2 (minimum)
Contrast: Ratio;600:1 (minimum)

Approvals: UL 1950, FCC-A, DHHS, CSA-950, IEC 950

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Operator’s
Appendix A—Specifications
Handheld Console Specifications

3.0 Handheld Console Specifications

Communications Interface: RS-422, differential input/output

4.0 Regulatory and Safety

Electrical:
Compliance: IEC 601-1 and UL2601
Leakage Currents: Less than 5000uA
Protective Earth Impedance: Less than 0.1 ohms maximum
Emergency Stop: E-stop located at end of tube arm, within
user reach under all expected operating
conditions. E-stop will disable all c-arm
movement functions and motorized
compression.
Mechanical:
Compliance: IEC 601-1 and UL2601
C-Arm Locks: Electric C-Arm locks provided. C-Arm
movement allowed only when C-Arm release
button depressed.
Safety Interlocks:
X-Ray Button: System will not enter READY state
following an exposure until the X-ray
button has been released.
READY State: System will not allow X-ray exposure unless in
a READY state. READY state is qualified by
DSM READY signal from the DSM sub-
system.
Backup Relay: System incorporates a relay circuit to
automatically remove current from the rotor
after 16 ±2 seconds following initiation of
an exposure.
Radiation Safety: Complies with 21CFR Part 1020

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Appendix B—Alerts, Alert Codes and Messages
DSM Console Alert Messages

Appendix B—Alerts, Alert Codes and Messages

1.0 DSM Console Alert Messages

Alert messages will appear on the bottom of the DSM screen as they occur. The following is
a list of the alert messages, their causes, and their solutions.

Table B-1: Power Up Messages

Power Up Messages
Message Description
RAM Error Turn the machine off, wait 30 seconds, then turn it back on. If the error
persists, call your authorized service engineer.
ROM Error Turn the machine off, wait 30 seconds, then turn it back on. If the error
persists, call your authorized service engineer.
Front Panel Switch Error A switch is jammed. Turn the machine off and try to free the switch. Wait 30
seconds, then turn it back on.
Clock Error The Date and Time information has been lost. Turn the machine off, wait 30
seconds, then turn it back on. After a successful power on condition, input the
current date and time.

Table B-2: Exposure Messages

Exposure Messages
Message Description
Analog Interface Error This error could occur during power up or X-ray exposure. Turn machine off
and re-power the system. If error occurs again, contact your authorized
service engineer.

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Operator’s
Appendix B—Alerts, Alert Codes and Messages
DSM Console Alert Messages

Table B-3: System Operation Faults

System Operation Faults
Message Description
Control Error High Voltage sense problem. Turn system off, then re-power. If error occurs
again, call your authorized service engineer.
Filament Control Error Improper powering of X-ray filament. The exposure control line stays in the
STANDBY mode. Re-power the system. If problem persists, contact your
authorized service engineer.
Tube Current Error Tube current is incorrect. Attempt exposure once more. If error persists, call
your authorized service engineer.
Fault Detected Attempt exposure again. If error persists, contact your authorized service
engineer.
Low Line Voltage Input power level is below MultiCare Platinum limits; temporarily stop
system operation and re-power.
Tube Rotor Fault X-ray Tube anode motor not coming up to speed properly. Immediately shut
the unit off and contact your authorized service engineer.
X-ray Button Fault X-ray button was released early (before exposure time duration). Press the
ENTER Key to resume normal operation. Film will be underexposed and
the exposure may need to be repeated.
System Fault System not operating correctly. Press ENTER Key and check data on
screen. DO NOT press the X-ray Button until this error is cleared.
Back-Up Timer Exposure length has reached the Back-Up Time of 5 seconds.
Filament Supply Error X-ray tube filament current is not at required level. If error persists, contact
your authorized service engineer.

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Appendix B—Alerts, Alert Codes and Messages
Handheld Console Alert Codes and Messages

2.0 Handheld Console Alert Codes and Messages

This section lists the alert codes that appear in the Run Mode Screen when a malfunction
occurs, and other pertinent information.

Table B-4: Monitoring/Error Messages

Monitoring/Error Messages
No. Message Description
N/A ERROR-CHECK This error is produced if any of the console switches are closed during
KEYPAD initial power up. The error is detected by the console circuit and has no
associated error number. Initialization is stopped until the switch is
open.
1 CONTROL Exposure time required exceeded Backup timer maximum.
1 EXP> AEC algorithm predicts exposure will exceed the programmed
BACKUP maximum exposure mAs.
05 EXP TIME AEC circuit returned invalid signal (saturated)
9 EXP < MIN AEC circuit returned invalid signal (no signal)
TIME
10 XRAY X-ray switch early release.
SWITCH
12 NV RAM Non-volatile RAM test error. Calibration values may have been
ERROR corrupted.
17 PARAMETER The stored calibration value is out of range, indicating possible
corruption of the calibration ram.
20 CONTROL ROTOR OK low.
25 CONTROL HV fault.
27 CONTROL Filament check in boost routine not within 12.5% of adaptive table of
DAC values.
29 DSM NAK A DSM message failed due to checksum, protocol, or preamble.
30 DSM LEN A DSM message failed due to excessive parameter length.
31 DSM PARAM A DSM message failed due to parameter range check.
44 CONTROL mA sense not within 12.5% expected value during exposure.
45 CONTROL kV sense (TP2) not within 12.5% expected value during exposure.

N/A COMM Error 68 Comm error between host and console implemented in
ERROR console code.

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Operator’s
Appendix B—Alerts, Alert Codes and Messages
Handheld Console Alert Codes and Messages

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Appendix C—Data Sheets
SMPTE Pattern Chart

Appendix C—Data Sheets

1.0 SMPTE Pattern Chart

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Operator’s
Appendix C—Data Sheets
SMPTE Pattern Chart

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 Operator’s
Index
Numerics

Index
Numerics Image Processing Menu Choice 46
Main Menu 43
1024 SMPTE 145
DICOM 84
512 SMPTE 145
Alert Messages 88
A Image Retrieval Status Messages 88
Queries Preferences Dialog Box
Acquiring a Single Image 114 85 Retrieval 86
Acquiring Stereo Images 125 DICOM Server 106
Alert Codes 161 Directory List Window 74
Aperture Display Brightness and Contrast Settings 146
Installing 52 DSM 20
Auto Archive Utility 106 Archive Media 109
Computer 24
B Formatting 109
Breast Platform Handheld Console 23
Adjustment 53 Keyboard 26
Placement 53 Monitor 23
Brightness and Contrast 147 Quality Control Test 144
Button Shut Down Procedure 48
Change keys 29 Trackball 25
Reset 29 DSM Operations
Reset Key 28 Custom Option 72
Scroll 29 Filter Option 68
X-Ray Exposure Key 28 Invert Option 65
Mag On Option 67
C Tools Option 69
Using The Image Processing Menu 63
Calcification Test 142 Window/Level Option 64
Calibration & Verification 111 Zoom-In Option 66
Cart 21 DSM System Controls and Display 20
Case Study Display Area 47
Case Study List 75 E
CD/DVD
Archive Media 109 Emergency Stop Switches
Certifiable Components 9 Locations 48
Cleaning and Disinfection 151 Emergency Stop switches 5
Compliance Requirements 6 Example
Compression Accuracy Test 140 Auto Archive Utility Sequence 107
Compression Paddles Exposure Defaults Screen
Installing 51 Handheld Console 33
Types 50 Exposure Mode
Control Panel in Run Mode 30 Manual 34
Exposure System Displays 31
D
F
Defaults screen
Handheld Console 29 Fiber Test 142
Descriptions File Manager Window 80
Annotation Area Data Field 45 Formatting

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DSM CD/DVD 109

Function Menu 82 M
Options 83 Main Menu
H Annotation Display 42
DSM Screen Overview 41
Handheld Console Setting Up 39
Display Screen 28 Mammography Phantom Test 141
Exposure Indicator 28 Mammography Test Setup 141
Function Keypad 28 Manual Axis Controls 20
Message Area 31 Masses Test 142
Status Area 31 Motor Control Keypad 17
Handheld Console Keys Motor Control Keypad Options
Change Keys 28 Home Position Key 17
Function Key 28 Target Key 17
Reset Key 28 Mounting
Scroll Keys 28 DSM Film Scout Holder 55
X-Ray Exposure Key 28 DSM Image Receptor 54
Handheld Console Screens 29 MultiCare Platinum
Exposure Defaults 29 Alert Codes and Messages
Run Mode 29 161 Host Verification 40
User Defaults 29 Specifications 153
Hardcopy Image Density and Contrast 148 User Training xi
Histogram Example 123 Multiple Passes 137
Multiple Targets 136
I
N
Image
Enhancements 73 Needle Calibration 111
List 76, 81 Needle Guidance Stage
Save 73 Operation 15
Saving 73 Needle Test Procedure 140
Image Quality Checks 150
Image Setup 139 O
Images Operation Menu 89
Copy 93 Operations Menu 89
Erase 90
Move 95 P
Recall 96
Installation Positioning The Table & C-arm 60
Compatible Biopsy Devices 56 Power Up Procedures 37
Installing Printing 96
Biopsy Device Holder 56 Available Film Formats 101
Front and Rear Needle Guides Print Film 100
59 Rear Needle Guide Mount 58 Print Screen 97
Intended Use xi
Q
L Quality Assurance 139
Lesion Targeting 130 Quick Sort 75
List All Button 77
R
Re-Annotate Utility 103

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S

Re-Annotating the Image File 103 Terms xii

Recall Case Study
Choose Image 79 U
Default 79
Initiate Search Options 78 Unit Description 2
Recalling A Case Study 78 User Defaults Screen
Recommended Performance Criterion and Handheld Console 32
Corrective Action 144 Using SMPTE Test Pattern 145
Reset button 29 Using the Operator’s Manual xi
RMI 156 Phantom 143
Run Mode Screen
V
Handheld Console 30 Verification Test 139

S
Safety
Emergency Stop Switches 5
Radiation 4
Technologist and Patient 4
Scroll keys 29
Search Button 77
Search File Manager Window 81
Search Menu 77
Setting Exposure Mode
Default Exposure 35
SMPTE 5% and 95% Inset Test Patches 146
SMPTE Test Pattern 145
Specifications 153
Speck Group Test 142
Stage
Entering Biopsy Instrument Parameters 113
Mode Selection 113
Stage Display Panels 16
Stage Keypad 18
Stereo Targeting 129
Storage Commitment 106
System Performance Checks 152
System Preparation 114

T
Table
Accessories 49
Control Panel 12
Levelers 14
Table Controls
C-arm Position Switches 13
C-arm Rotation Switches 13
C-arm Up/Down Switches
13 Lamp Switch 14
Safety Keyswitch 13
Table positioning and breast compression controls 60

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