Insightec Exablate 2100V1 User manual

1
Exablate 2100V1
Prostate System
Operator’s Manual
Software Version 8.1
Publication Date (MM YYYY)UAL

Manual Part Number
2
Copyright ©2021 InSightec Ltd. (“INSIGHTEC”), all rights reserved.
The Exablate MR guided focused ultrasound system, processing software, and its related documentation
are the confidential proprietary information of INSIGHTEC. Only licensees of INSIGHTEC (“INSIGHTEC”) have
the right to use the information contained herein. Only licensees specifically granted copy and/or transfer
rights have the right to copy and/or transfer this information. Any unauthorized use, disclosure, assignment,
transfer, or reproduction of this confidential information will be prosecuted to the full extent of the law.
INSIGHTEC shall not be liable nor obliged in any manner in respect to any bodily injury and/or property
damage arising from the use of this software if such use is not in strict compliance with the instructions and
safety precautions contained in the relevant operating manuals including all supplements thereto, in all
product labels, and according to the terms of warranty and sale of this software, nor if any changes
unauthorized by INSIGHTEC are made to the software contained herein.
User provided programs or protocols are not validated nor are they warranted by INSIGHTEC. The use of
data obtained with such user provided software or protocols are the sole responsibility of the user.
Users should be aware of the risk of the transmission of computer viruses by exchanging files and CDs.
Trademarks of third-party proprietors are the sole property of those proprietors.
Specifications are subject to change without notice and following applicable regulation and laws.
One or more parts of the Product may incorporate or be distributed with open source software. Please refer
to the Copyright Notice button in the Utilities Screen.
This document is the property of INSIGHTEC Ltd., and contains proprietary and confidential information of
INSIGHTEC Ltd. A nondisclosure agreement between the recipient and INSIGHTEC Ltd. has been executed
prior to receipt of this document. This document is loaned on the express conditions that neither it nor the
information contained therein shall be disclosed to others without the express consent of INSIGHTEC Ltd.
In addition, the document shall be returned to INSIGHTEC Ltd. upon request with no copies made.
Contact information for equipment manufacturer and technical services:

REVISION HISTORY
Manual Part Number
3
REVISION INFORMATION
Manual Catalog Number: PUB71004685, Rev. 1.0
Revision Release Date: April 2021
This is the Revision 1 release of the Exablate Prostate Operator's Manual for Software Version 8.1,
applicable for 1.5- and 3-Tesla MR system(s). Contact INSIGHTEC Marketing Support to determine if this is
the most current release of this operator's manual.
Each page of this manual has a chapter revision level and date at the bottom. This indicates the release
level and date for the individual chapters. Note that when the manual is updated, not all of the chapters
are necessarily updated, so some chapters may have a revision level earlier than the release revision level
for the manual (the revision level designation for the manual is that which appears on the top of the second
page of this manual). The following table provides a complete list of the revision information, by chapter,
for this release of the operator's manual.
CHAPTER #
CHAPTER NAME
CHAPTER REVISION & DATE
Chapter 1
System Overview
1.0, 04/2021
Chapter 2
Safety
1.0, 04/2021
Chapter 3
Getting Started
1.0, 04/2021
Chapter 4
System Start-Up
1.0, 04/2021
Chapter 5
Treatment Tools
1.0, 04/2021
Chapter 6
Planning Stage
1.0, 04/2021
Chapter 7
Treatment Stage
1.0, 04/2021
Chapter 8
Evaluation Stage
1.0, 04/2021
Chapter 9
Replay Stage
1.0, 04/2021
Chapter 10
Utilities
1.0, 04/2021
Chapter 11
Data Management
1.0, 04/2021
Appendix A
Advanced Option Mode
1.0, 04/2021
Appendix B
Water System Maintenance
1.0, 04/2021
Appendix C
High-Level Disinfection
1.0, 04/2021

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1. SYSTEM OVERVIEW 13
1.1. Introduction..................................................................................................................................13
1.2. Document Conventions ................................................................................................................13
1.3. Scope of This Manual ...................................................................................................................13
1.4. System Components.....................................................................................................................16
1.4.1. Operating Console .....................................................................................................................16
1.4.2. Patient Table .............................................................................................................................16
1.4.2.1. Positioner....................................................................................................................... 18
1.4.2.2. Probe Shell.....................................................................................................................18
1.4.2.3. Transducer.....................................................................................................................18
1.4.2.4. MR Tracking Coils...........................................................................................................18
1.4.2.5. Robotic Motion Unit ......................................................................................................19
1.4.2.6. Probe Preparation Station .............................................................................................19
1.4.2.7. Patient Legs Support......................................................................................................20
1.4.3. Equipment Cabinet....................................................................................................................21
1.4.4. Water System ............................................................................................................................22
1.4.5. Power Distribution Unit (PDU)...................................................................................................24
1.4.6. Cleaning and High-Level Disinfection (HLD) Cart .......................................................................25
1.5. Exablate Prostate Accessory List................................................................................................... 25
2. SAFETY 27
2.1. Exablate Safety Considerations ....................................................................................................27
2.1.1. Use of Exablate System within the MRI Environment................................................................28
2.1.2. Use of MR Equipment................................................................................................................ 28
2.1.3. System Service...........................................................................................................................28
2.2. Symbols Used in the System.........................................................................................................28
2.3. Safety Instructions........................................................................................................................32
2.3.1. MR Coils..................................................................................................................................... 33
2.3.2. Patient Positioning.....................................................................................................................33
2.3.3. Patient Protection .....................................................................................................................33
2.3.4. Patient Emergencies..................................................................................................................35
2.3.4.1. Patient Emergency Release............................................................................................35
2.3.5. System Stability .........................................................................................................................36
2.4. Water System Precautions ...........................................................................................................37
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2.4.1. Temperature Rise Precautions ..................................................................................................37
2.4.2. Balloon Volume Precautions......................................................................................................37
2.5. Operator Precautions ...................................................................................................................38
2.6. System Security and Malware Protection.....................................................................................39
2.7. Electromagnetic Compatibility (EMC) Precautions .......................................................................40
2.7.1. Summary of EMC Test Results ...................................................................................................41
2.8. Cyber-Security ..............................................................................................................................42
2.8.1. Cyber-Security Related Precautions .......................................................................................... 42
2.8.2. Cyber-Security Related Notes and Instructions .........................................................................43
2.9. Environmental Requirements.......................................................................................................44
3. GETTING STRTED 45
3.1. System Power On .........................................................................................................................45
3.2. Probe Preparation for Treatment .................................................................................................49
3.3. Patient Preparatory Procedures ...................................................................................................51
3.4. Patient Positioning and Probe Insertion .......................................................................................51
3.5. Patient Release............................................................................................................................. 54
3.6. Shutdown .....................................................................................................................................54
3.7. Daily Quality Assurance (DQA) Test Procedure.............................................................................55
3.7.1. DQA Set Up Procedure ..............................................................................................................55
3.8. Storage and Maintenance of the DQA Phantom Gel .................................................................... 57
4. SYSTEM START-UP 58
4.1. Start-Up Screen ............................................................................................................................ 58
4.2. Treatment Options .......................................................................................................................58
4.2.1. Start Treatment .........................................................................................................................59
4.2.2. Command Buttons.....................................................................................................................59
4.2.3. Status Bar ..................................................................................................................................59
4.3. Begin Treatment Procedure .........................................................................................................60
5. TREATMENT TOOLS 61
5.1. Treatment Tools - Overview .........................................................................................................61
5.2. Treatment Screen.........................................................................................................................61
5.2.1. Exablate Main Toolbar...............................................................................................................62
5.2.2. Treatment Stages ......................................................................................................................62
5.2.2.1. Planning Stage ...............................................................................................................62

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5.2.2.2. Treatment Stage ............................................................................................................63
5.2.2.3. Evaluation Stage ............................................................................................................63
5.2.3. Information Area .......................................................................................................................63
5.2.4. Utilities ......................................................................................................................................63
5.2.5. Image Strips...............................................................................................................................63
5.2.6. Selected Image Window ............................................................................................................64
5.2.7. Imaging Tools ............................................................................................................................64
5.2.8. Overlays.....................................................................................................................................66
5.2.9. Navigation Tools ........................................................................................................................67
5.2.10. Image Overlays ........................................................................................................................68
5.2.10.1. Image Annotations.........................................................................................................68
5.2.10.2. Cursor Coordinates ........................................................................................................68
5.2.10.3. Shadow Cursor...............................................................................................................69
5.2.10.4. Three-Dimensional Display ............................................................................................69
6. PLANNING STAGE 71
6.1. Planning Stage - Overview ............................................................................................................71
6.2. Planning Stage General Action Elements......................................................................................72
6.3. Baseline Thermometry .................................................................................................................73
6.4. Positioning Verification.................................................................................................................73
6.4.1. Validate Treatment Envelope Coverage ....................................................................................74
6.4.2. Acquire Calibration Scans ..........................................................................................................75
6.4.3. Verify Acoustic Coupling............................................................................................................75
6.4.4. Approve Positioning ..................................................................................................................77
6.5. Acquisition of MR Planning images...............................................................................................77
6.5.1. User Interface Elements ............................................................................................................ 78
6.5.2. Define the Scanning Range........................................................................................................78
6.5.3. Automatic Acquisition of Planning Images ................................................................................79
6.5.4. Manual Acquisition of MR Planning Images ..............................................................................80
6.5.5. Reformat of Axial Planning Images ............................................................................................ 81
6.5.6. Loading Additional Planning Images (Optional).........................................................................82
6.5.6.1. User Interface Elements.................................................................................................82
6.5.7. Loading Prior Exams (Optional) .................................................................................................83
6.6. Acquisition of Baseline Anatomy Scans ........................................................................................ 83

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6.6.1. User Interface Elements ............................................................................................................ 84
6.7. Defining a Treatment Plan............................................................................................................84
6.7.1. Action Tools...............................................................................................................................85
6.7.2. Draw the Rectal Wall .................................................................................................................85
6.7.3. Draw the Prostate Capsule ........................................................................................................ 86
6.7.4. Define the Region of Treatment (ROT) ......................................................................................87
6.7.5. Automatic Balloon Boundaries Detection..................................................................................88
6.7.6. Draw Limited Energy Density Regions (LEDR’s) - Optional.........................................................90
6.8. Selecting a Treatment Protocol (Optional) ...................................................................................92
6.8.1. Changing Treatment Protocol Parameters ................................................................................93
6.8.2. System Preset Treatment Protocols ..........................................................................................96
6.9. Re-Draw / Dose Transfer (Optional) .............................................................................................97
6.9.1. Acquiring New Planning Images ................................................................................................97
6.9.2. Dose Transfer Procedure ...........................................................................................................97
6.10. Advancing to Treatment Stage ...................................................................................................99
7. TREATMENT STAGE 100
7.1. Overview ....................................................................................................................................100
7.2. Treatment Stage Main Screen ....................................................................................................101
7.2.1. Action Tools.............................................................................................................................101
7.2.2. Treatment Modes.................................................................................................................... 102
7.2.3. Spot Parameters Frame ...........................................................................................................102
7.2.4. Scan Parameters Frame...........................................................................................................103
7.2.5. General Parameters Frame......................................................................................................104
7.2.6. Treatment Parameters Frame .................................................................................................104
7.2.7. Spot Colors .............................................................................................................................. 105
7.2.8. Current and Previous Anatomy Scans...................................................................................... 105
7.2.9. Automatic Movement Detection.............................................................................................106
7.2.10. Deformation Mode................................................................................................................ 108
7.2.11. Handling Probe Movements ..................................................................................................110
7.3. Thermal Evaluation Screen .........................................................................................................111
7.3.1. Image Strips.............................................................................................................................111
7.3.2. Thermal Evaluation Action Tools .............................................................................................112
7.3.3. Continue Treatment Tools.......................................................................................................113

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7.3.4. Temperature Scaling Tools ......................................................................................................113
7.3.5. Measured Sonication Parameters Indicators........................................................................... 114
7.3.6. Temperature Graph................................................................................................................. 114
7.3.7. Acoustic Spectrum...................................................................................................................115
7.4. Treatment Procedure ................................................................................................................. 115
7.4.1. General Sonication Flow..........................................................................................................115
7.4.2. Adding a new Sonication Spot ................................................................................................. 118
7.4.3. Geometric Verification (Align Mode).......................................................................................119
7.4.3.1. Perform a Geometric Verification Sonication ..............................................................119
7.4.3.2. Geometric Adjustment ................................................................................................120
7.4.4. Thermal Dose Verification (Treat Mode) .................................................................................123
7.4.5. Performing Macro-Spot Sonications........................................................................................126
7.4.6. Repeat Under-Heated Regions (Optional) ...............................................................................129
7.5. Conclusion of the Treatment Session .........................................................................................132
8. EVALUATION STAGE 133
8.1. Overview ....................................................................................................................................133
8.2. Action Tools................................................................................................................................134
8.3. Automatic Evaluation Scan Acquisition ......................................................................................134
8.4. Manual Evaluation Scan Acquisition........................................................................................... 135
8.5. Volume Measurement................................................................................................................135
8.6. Exit Evaluation Stage ..................................................................................................................135
9. REPLAY STAGE 136
9.1. Overview ....................................................................................................................................136
9.2. Replay Action Tools ....................................................................................................................137
9.3. Exit Replay ..................................................................................................................................137
10. UTILITIES 138
10.1. Overview ..................................................................................................................................138
10.1.1. Utilities Action Tools.............................................................................................................. 138
10.2. Utilities Procedures .................................................................................................................. 139
10.2.1. Select Exam ........................................................................................................................... 139
10.2.2. Setup MR Protocols ...............................................................................................................140
10.2.3. Optimize Coil Signal ...............................................................................................................140
10.2.4. Turn System Hardware On/Off ..............................................................................................140

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10.2.5. Connect/Disconnect to the Site Network ..............................................................................141
10.2.6. Change Macro-Spot Planner Configuration ...........................................................................141
10.2.7. Copyright Notice....................................................................................................................142
10.3. Exit Utilities............................................................................................................................... 142
11. DATA MANAGEMENT 143
11.1. Overview ..................................................................................................................................143
11.2. Selecting a Patient .................................................................................................................... 144
11.2.1. Action Tools...........................................................................................................................144
11.2.2. Export to CD or USB Storage Device ......................................................................................145
11.2.3. Import Treatment Records from CD or USB Storage Device..................................................146
11.2.4. Screen Dump to CD or USB Storage Device ........................................................................... 146
11.2.5. Erase Selected Treatment Record..........................................................................................146
11.2.6. Technical Export to CD or USB Storage Device ......................................................................147
11.2.7. Download MR Images............................................................................................................147
11.3. External Database (Optional)....................................................................................................149
11.3.1. Action Tools...........................................................................................................................149
11.3.2. Select Database .....................................................................................................................150
11.3.3. Delete Complete Treatment Record......................................................................................150
11.3.4. Records Management ...........................................................................................................150
11.4. Exit Data Management .............................................................................................................150
APPENDIX A. ADVANCED OPTION MODE 151
A.1. Overview .................................................................................................................................151
A.2. Sonication Parameters.............................................................................................................152
A.3. MR Scan Parameters ...............................................................................................................153
A.3.1. Changing MR Parameters ....................................................................................................153
A.3.2. Profile Parameters Elements ...............................................................................................154
A.3.3. Parameter Settings ..............................................................................................................155
APPENDIX B. WATER SYSTEM CLEANING AND HIGH-LEVEL DISINFECTION 156
B.1. Overview.......................................................................................................................... 156
B.2. Water System Troubleshooting ....................................................................................... 156
B.2.1. Handling Water System Errors.........................................................................................156
B.2.2. Water System Troubleshooting Table.............................................................................. 156
APPENDIX C. HIGH-LEVEL DISINFECTION PROCEDURE 159

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C.1. Introduction............................................................................................................................. 159
C.2. List of Materials Required for Cleaning....................................................................................159
C.3. HLD Procedure.........................................................................................................................160
C.3.1 Cleaning and Disinfection Cart Preparation .....................................................................160
C.3.2 Post-Treatment Procedure .............................................................................................. 161
C.3.3 Probe Cleaning.................................................................................................................161
C.3.4 Probe Disinfection ...........................................................................................................162
C.3.5 Probe Rinsing...................................................................................................................163
C.3.6 Post-HLD ..........................................................................................................................163

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LIST OF FIGURES
Figure 1-1: Operating Console of 2100V1..................................................................................................16
Figure 1-2: The Patient Table of Exablate 2100V1.....................................................................................17
Figure 1-3: A closer look on the Patient Table...........................................................................................17
Figure 1-4: Exablate Prostate Probe ..........................................................................................................17
Figure 1-5: Probe in Preparation Station ...................................................................................................19
Figure 1-6: Patient Leg Support.................................................................................................................20
Figure 1-7: Exablate Prostate Equipment Cabinet..................................................................................... 21
Figure 1-8: Exablate Prostate Cooling Unit (2100V1 Forward Production)................................................23
Figure 1-9: Exablate Prostate Secondary Water Circuit............................................................................. 23
Figure 1-10: Exablate Prostate water system display ................................................................................ 24
Figure 1-11: Exablate Prostate console .....................................................................................................24
Figure 1-12: Cleaning and High-Level Disinfection Cart............................................................................. 25
Figure 4-1: Start-Up Screen .......................................................................................................................58
Figure 4-2: Device and MR Status Bar .......................................................................................................59
Figure 4-3: Treatment Data Dialog Box .....................................................................................................60
Figure 5-1: Treatment Screen....................................................................................................................61
Figure 5-2: The Exablate Main Toolbar......................................................................................................62
Figure 5-3: Cursor Coordinates.................................................................................................................. 68
Figure 5-4: Three-Dimensional Display Screen ..........................................................................................69
Figure 6-1: Planning Screen.......................................................................................................................72
Figure 6-2: Treatment Envelope (blue) displayed on Sagittal Positioning image (left) and on Axial Positioning
image (right)..............................................................................................................................................74
Figure 6-3: Air bubbles as seen in a Bubble Detection scan ......................................................................77
Figure 6-4: Scan Range lines......................................................................................................................79
Figure 6-5: Planning stage –Loading Form................................................................................................81
Figure 6-6: Balloon Boundaries (yellow arc)..............................................................................................90
Figure 6-7: Planning images with drawing overlays (left –Axial, right –Coronal) .....................................92
Figure 6-8: Treatment Protocol control.....................................................................................................92
Figure 6-9: Treatment Protocol Dialog ......................................................................................................93
Figure 6-10: Dose Transfer procedure.......................................................................................................98
Figure 7-1: Treatment Stage Main Screen ...............................................................................................101
Figure 7-2: Movement Detection Fiducials..............................................................................................108

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Figure 7-3: Deformation Mode................................................................................................................ 110
Figure 7-4: Thermal Evaluation Screen Elements .................................................................................... 111
Figure 7-5: Measured Sonication Parameters Indicators.........................................................................114
Figure 7-6: Temperature Graphs (left –nominal, right –thermal noise).................................................114
Figure 7-7: Acoustic Spectrum Graphs (left - typical, right –Cavitation effect)....................................... 115
Figure 7-8: Geometrical Adjustment Procedure......................................................................................122
Figure 7-9: Thermal Dose Adjustment Procedure ...................................................................................126
Figure 7-10: Under-Heated Regions Polygon...........................................................................................131
Figure 8-1: Evaluation Screen Elements .................................................................................................. 133
Figure 9-1: Replay Screen........................................................................................................................136
Figure 10-1: Utilities Screen ....................................................................................................................138
Figure 10-2: Planner Configuration ......................................................................................................... 142
Figure 11-1: Data Management Screen................................................................................................... 143
Figure 11-2: CD Disk Label Dialog Box .....................................................................................................145
Figure 11-3: CD Disk Label Dialog Box .....................................................................................................147
Figure 11-4: Download MR Images Screen..............................................................................................148
Figure 11-5: Data Management Screen –System with External Database..............................................149
Figure A-1: Sonication Parameters Dialog Box ........................................................................................152
Figure A-2: MR Scan Parameters Dialog Box ...........................................................................................153

SYSTEM OVERVIEW
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1. SYSTEM OVERVIEW
1.1. Introduction
INSIGHTEC Exablate Prostate delivers MR-guided focused ultrasound energy into the prostate in a minimally
invasive manner by utilizing an endorectal transducer. In a matter of seconds, the tissue at the focal spot
of the ultrasound beam is heated to the point of irreversible thermal coagulation, while nearby tissue
remains unaffected. Over time, the body gradually absorbs the ablated tissue. This procedure is typically
performed in an outpatient setting using either Epidural anesthesia (combined with conscious sedation) or
general anesthesia. The patient is usually able to return to normal activity the following day.
The Exablate Prostate's focused ultrasound system operates inside a Magnetic Resonance Imaging (MRI)
scanner, used to provide images of the patient’s anatomy, and prepare an appropriate treatment plan. The
MRI also measures temperature changes inside the body during Focused Ultrasound (FUS) treatment. The
system acquires MR images and runs dedicated sequences to display temperature maps. The temperature
maps are used to calculate the extent of thermal ablation and to help ensure safety and efficacy.
1.2. Document Conventions
Notes, Cautions and Warnings are used throughout this manual to highlight important points of information
that could affect the health and safety of the patient and operator, as well as information intended to
preserve system integrity. The following conventions are used to highlight these messages:
NOTE:
Notes provide information to aid in obtaining optimum equipment performance.
CAUTION:
Cautions indicate instructions or cautionary notes that, if not followed, may result in
damage to the equipment or to the quality of treatment.
WARNING:
Warnings indicate precautions and instructions which, if not followed, may result in
personal injury or even death .
1.3. Scope of This Manual
This operator's manual covers the following systems:
◼MR scanner: 1.5 and 3-Tesla
◼System Model: 2100V1

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◼Cradle Type: 3.0 (Prostate)
◼Software version: 8.1
System Specifications:
◼Transducer: 990 transmit elements flat phase array
◼Transducer aperture (diameter): 34x22mm
◼Focal distance: 15-60mm (achieved by electronic steering)
◼Frequencies: 2.3±0.25Mhz
◼Maximal Energy per
macro-spot: 30KJ
◼Maximal energy per sub-spot: 2.2KJ
◼Energy specifications:
●Energy density in target: 400~800J/cm2
●Ultrasound output: ~45W
●Max output pulse width: 512sec
◼Effective radiating area (ERA): 748mm2
◼Focal region size: Variable
◼Focal control: Electronic
◼Tissue destruction mechanism: Thermal coagulative necrosis
◼Imaging during treatment: PRF MR Images at 3-6seconds interval
◼Temperature measurement: Proton Resonance Frequency (PRF) MR thermometry
◼Reflection monitoring: None
◼Cavitation monitoring: Real time display
◼Treatment outcome monitoring method: Using real-time thermometry the operator gets real time
feedback on treatment outcome, as temperature is correlated to tissue viability.
◼Independent assessment using standard MR imaging sequences is done during and after treatment,
to assess lesion size and location.
◼System Electrical Specifications:
●Rated power voltages/currents: 208V (30A) / 380-400V (15A) / 480V (13A)

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●Number of phases: Input 3-phase (5 wire)
●Rated power frequency: 50/60Hz
●Rated power input: ~10Kva
●Protection against electric shock: Applied Part Type BF
◼Exablate Table Specifications:
●Dimensions (L x W x H): 231±1 x 65±1 x 110.5±1 cm
●Height in lowest position: 90cm
●Weight: 230Kg
◼Cleaning and High-Level Disinfection Cart Specifications:
●Dimensions (L x W x H): 80±1 x 58±1 x 118±1 cm
●Net weight: 25Kg
●Full weight (with liquids): 39Kg

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1.4. System Components
The Exablate Prostate system consists of the following integrated components:
◼Operating console (located in the control room)
◼Patient table (located in the MR treatment room)
◼Equipment cabinet with Control PC (located in the equipment room)
◼Water system (primary circuit located in the equipment room; secondary circuit located on the
patient table)
◼Power Distribution Unit (PDU)
◼Cleaning and High-Level Disinfection (HLD) cart
1.4.1. Operating Console
The Exablate Prostate console (see Figure 1-1) allows the operator to control and monitor both the system
and the treatment. It is positioned alongside the GE (General Electric) MRI workstation in the control room.
The WorkStation (WS) comprises the Exablate software installed on a Windows-based PC (Windows 7/10
operating system), a monitor, a keyboard, and a mouse. The Exablate console also consists of an emergency
stop button (colored red) that halts the power to the system in case of emergency.
Figure 1-1: Operating Console of 2100V1
1.4.2. Patient Table
The Patient Table (see Figure 1-2), on which the patient lies during treatment, incorporates a probe (see
Figure 1-3, A) containing a phased array focused ultrasound transducer (Figure 1 4) mounted on a
mechanical positioner (see Figure 1-3, B). In addition, it houses a motion unit (see Figure 1-3, C) and the
electronics needed to activate the transducer.

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Prior to treatment, the patient table is docked to the MR Scanner. A quick-coupler cable connects the
patient table to the equipment cabinet.
Figure 1-2: The Patient Table of Exablate 2100V1
Figure 1-3: A closer look on the Patient Table
Figure 1-4: Exablate Prostate Probe
The following legend explains the
components shown in Figure 1-3:
A –Probe
B –Positioner
C –Motion unit

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1.4.2.1. Positioner
A positioner (see Figure 1-3, B) mechanically attached to the cradle fixes the probe in place during the
treatment. However, it still allows automatic mechanical movement of the transducer inside the shell in
two dimensions. The positioner is designed so it would reduce pressure on the anus and eliminate any
motion in the anus during the treatment.
The positioner has six degrees of freedom to easily adjust it to the probe location after insertion.
1.4.2.2. Probe Shell
The probe shell (see Figure 1-4) function is to keep the rectum and the anus safe while allowing energy
delivery with minimum acoustic attenuation and dispersion and free mechanic transducer motion. The
shell’s dimensions and shape were designed to facilitate its insertion/extraction through the anus. The shell
has no sharp edges nor steps that could have harm the rectal wall, and its oblique tip is intended to facilitate
safe insertion. The transducer is locked in its position inside the shell while inserting or extracting it.
1.4.2.3. Transducer
The 990-elements phased array transducer was designed to be small yet powerful. It delivers ultrasound
energy in a frequency of 2.3 MHz for high energy absorption in the prostate tissue. It can deliver up to 60W
(acoustic); yet power is currently limited to 45W to avoid cavitation. The focus of the US beam transmitted
by the transducer at the working distance of 15mm to 60mm is ~1mm to ~2.5mm in diameter (according
to approximated measures of -6db contour), thus it creates well defined spot margins. This feature is
important for full tumor ablation, even when adjacent to vulnerable structures such as the nerve bundles
and the urethra.
The 990 elements of the phased array transducer enable electrical steering of the US beam 15mm-60mm
away from the transducer (A/P), +/-5 degrees transversally (R/L) and +/-10 degrees longitudinally (S/I); this
ability have a few implications, in addition to simple spot relocation. First, it increases the transducer
possible treatment range (mechanical 50mm in S/I and ±40 degrees roll) to allow total prostate coverage,
without passing the beam through the anus muscle. Second, it enables creating spots of various sizes and
shapes without moving the transducer, using a 'bean' shape building block. This allows good control of the
planned spots to maximize efficacy and safety.
1.4.2.4. MR Tracking Coils
The prostate motion system location control is based on relative encoders with index only. As an additional
safety measure, an MR tracking subsystem is used to verify the transducer spatial location before every
sonication and to re-aim it accordingly if necessary. The MR tracking subsystem includes four miniature

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tracking coils, named ‘trackers’, that are embedded in the four corners of the transducer’s housing. The
signal acquired by the four trackers is analyzed to define the position of the transducer in the MR
coordinates.
1.4.2.5. Robotic Motion Unit
The transducer has two mechanical degrees of automatic motion: linear motion of 50mm along the
horizontal (S/I) axis and angular motion of ±40 degrees around the roll (Axial) axis, enabling access to whole
desired treatment volume in the prostate gland. The automatic motion is achieved by a motion unit (Figure
1-3, C), attached to the prostate positioner on one end and to the probe on the other end. The motion
system consists of piezoelectric motors activating the two degrees of freedom of the mechanical motion
described above.
1.4.2.6. Probe Preparation Station
During the system preparation stage, the probe must be secured to avoid the hazard of its being damaged
or broken. In addition, the degassing process is more efficient when the probe is vertical, facing down, as
the tube opening is adjacent to the probe’s neck and this way the air bubbles go up to it. For those
purposes, the system includes a probe holder, as seen in Figure 1-5.
Figure 1-5: Probe in Preparation Station

SYSTEM OVERVIEW
Manual Part Number
20
1.4.2.7. Patient Legs Support
During the treatment, the patient’s body must stay immobilized to avoid miss-targeting and thermal
artifacts. Epidural/general anesthesia keeps the patient lower body temporary immobile throughout the
treatment duration, yet legs support is required for holding them slightly spaced and elevated and with
some knee flexion. This position allows room for the positioner while still enabling entrance to the MR bore.
The specially designed patient leg holders provide patient immobilization while uncompromising patient
comfort. The supporting Leg Holders are attached to the cradle and are adjustable in S/I and can also be
rotated as necessary.
Figure 1-6: Patient Leg Support