Insightec Exablate 2100V1 Manuel utilisateur

Exablate 2100V1

Prostate System

Operator’s Manual

Software Version 8.1

Publication Date (MM YYYY)UAL

Manual Part Number

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

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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

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Users should be aware of the risk of the transmission of computer viruses by exchanging files and CDs.

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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.

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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

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

TABLE OF CONTENTS

Manual Part Number

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

TABLE OF CONTENTS

Manual Part Number

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

TABLE OF CONTENTS

Manual Part Number

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

TABLE OF CONTENTS

Manual Part Number

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

TABLE OF CONTENTS

Manual Part Number

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

TABLE OF CONTENTS

Manual Part Number

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

TABLE OF CONTENTS

Manual Part Number

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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