Profound Sonalleve MR-HIFU User manual

Sonalleve MR-HIFU
Instructions for Use - Desmoid Application
English / Release 3.7

SONALLEVE MR-HIFU
109745C2
Profound Medical Inc.
2400 Skymark Avenue, Unit 6
Mississauga, ON, Canada, L4W 5K5
www.profoundmedical.com
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Tel.: [phone]
Fax: [phone]
www.mdss.com
© Profound Medical Inc., 2020.
All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means,
electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from Profound
Medical Inc.

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1. Introduction to Sonalleve MR-HIFU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1. About Sonalleve MR-HIFU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2. About this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.1. Notations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3. Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.1. Sonalleve Desmoid Application . . . . . . . . . . . . . . . . . . . . . . . . .
1.4. Operator profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5. Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6. Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7. Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8. Installation instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.9. System classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2. Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1. General safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2. Contraindications and restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3. Heat and Specific Absorption Rate (SAR) . . . . . . . . . . . . . . . . . . . . . . .
2.3.1. Specific Absorption Rate (SAR) . . . . . . . . . . . . . . . . . . . . . .
2.3.2. Specific Energy Dose (SED) . . . . . . . . . . . . . . . . . . . . . . . . .
2.3.3. Heat load induced by ultrasound . . . . . . . . . . . . . . . . . . . . . .
2.3.4. Cooling the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3.5. Clothing and environmental conditions . . . . . . . . . . . . . . . . .
2.4. Contrast agents and medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5. Emergency Stop and Safety Devices . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5.1. Patient Emergency Stop Button (PESB) . . . . . . . . . . . . . . . .
2.5.2. Safety Device (SD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5.3. Software Abort Sonication button . . . . . . . . . . . . . . . . . . . . .
2.6. Emergency procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.7. Magnetic safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.8. Mechanical and electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.9. Protecting the equipment against liquids . . . . . . . . . . . . . . . . . . . . . . . .
2.10. Chemical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.11. Explosion safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.12. Fire safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.13. Battery safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.14. Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . .
2.15. Network safety, data security and privacy . . . . . . . . . . . . . . . . . . . . . .
2.15.1. Malware detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.15.2. Remote Desktop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.16. Reporting of incidents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.17. Safety improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.18. Symbols and labels on the equipment . . . . . . . . . . . . . . . . . . . . . . . . .
3. System overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1. Main system components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1.1. Table Top assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1.2. Sonalleve Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1.3. Sonalleve Generator Cabinet . . . . . . . . . . . . . . . . . . . . . . . .
3.2. Patient accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3.2.1. Acoustic contact liquid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3. Other accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.1. The DISCfill tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4. Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4.1. Ultrasound field distributions . . . . . . . . . . . . . . . . . . . . . . . . .
4. Treatment methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1. Basic concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2. Patient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3. Sonication method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4. Electronic deflection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5. Temperature monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.1. Thermal dose limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.2. Thermal dose and temperature monitoring . . . . . . . . . . . . . .
4.5.3. Monitoring near-field heating . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.4. Cooling time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.5. Temperature limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.6. Motion detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.6.1. Misplaced heating or motion artefact? . . . . . . . . . . . . . . . . .
5. User interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2. Starting the Sonalleve MR-HIFU application . . . . . . . . . . . . . . . . . . . . .
5.2.1. Selecting the configuration . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.2. Selecting between the Therapy and Standalone mode . . . .
5.3. Exiting Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.4. Exiting the Sonalleve MR-HIFU application . . . . . . . . . . . . . . . . . . . . . .
5.5. Therapy application screen layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.6. Therapy Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.7. Viewing images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.7.1. Basic viewing tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.7.2. Advanced viewing tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.7.3. Overlay tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.8. Adding, selecting and removing objects . . . . . . . . . . . . . . . . . . . . . . . . .
5.9. Controlling and monitoring the sonication . . . . . . . . . . . . . . . . . . . . . . .
5.9.1. System Status Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.9.2. Sonication buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.9.3. Temperature and thermal dose . . . . . . . . . . . . . . . . . . . . . . .
5.9.4. Temperature curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.9.5. Message area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.10. Reporting and logging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.10.1. Generating reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.10.2. Taking snapshots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.10.3. Viewing and exporting logs . . . . . . . . . . . . . . . . . . . . . . . . .
5.11. Saving and recovering your work . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.12. Language settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.13. Keyboard shortcuts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6. Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2. Preparing the equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2.1. Connecting the Sonalleve Table Top . . . . . . . . . . . . . . . . . . .
6.2.2. Preparing the Table Top for the patient . . . . . . . . . . . . . . . . .
6.3. Preparing the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6.3.1. Positioning the patient on the table . . . . . . . . . . . . . . . . . . . .
6.3.2. Verifying the patient positioning . . . . . . . . . . . . . . . . . . . . . .
6.4. Scanning the planning images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.5. Preparing the monitor scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6. Therapy planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.1. Starting Therapy in the Sonalleve MR-HIFU application . . .
6.6.2. Entering patient information . . . . . . . . . . . . . . . . . . . . . . . .
6.6.3. Retrieving the image sets . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.4. Defining the Planning Target Volume . . . . . . . . . . . . . . . . .
6.6.5. Defining the Tissue Boundary . . . . . . . . . . . . . . . . . . . . . . .
6.6.6. Positioning the treatment volume . . . . . . . . . . . . . . . . . . . .
6.6.7. Beam shaping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7. Preparing the system for sonication . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7.1. Hardware Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7.2. Scanning Temperature Mapping . . . . . . . . . . . . . . . . . . . . .
6.7.3. Test sonication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8. Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.1. Replanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.2. Planning the sonication order . . . . . . . . . . . . . . . . . . . . . . .
6.8.3. Determining the correct frequency level for a treatment
cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.4. Determining the correct power level for a treatment cell . . .
6.8.5. Adjusting the sonication duration for a regular treatment
cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.6. Sonicating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.7. Reviewing the sonication results during the cooling time . .
6.8.8. Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.9. Scanning other protocols from the Sonalleve console . . . .
6.8.10. Saving the treatment data . . . . . . . . . . . . . . . . . . . . . . . . .
6.9. Post treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.10. Error recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.11. Removing the Sonalleve Table Top . . . . . . . . . . . . . . . . . . . . . . . . . .
6.12. Sonalleve Table Top storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1. Routine maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.1. Planned Maintenance Program . . . . . . . . . . . . . . . . . . . . . .
7.1.2. User Routine Checks Program . . . . . . . . . . . . . . . . . . . . . .
7.2. Sonalleve MR-HIFU Quality Assurance (QA) procedure . . . . . . . . . . .
7.2.1. Preparing the QA phantom for use . . . . . . . . . . . . . . . . . . .
7.2.2. Performing the QA Test . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2.3. QA Test troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2.4. Storing the QA phantom . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.3. Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.3.1. Cleaning the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.3.2. Cleaning the vacuum cushion . . . . . . . . . . . . . . . . . . . . . . .
7.3.3. Cleaning the DISCfill tool . . . . . . . . . . . . . . . . . . . . . . . . . .
7.4. Making degassed acoustic contact liquid . . . . . . . . . . . . . . . . . . . . . . .
7.5. Ultrasound protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8. System Error and Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1. Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.2. Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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8.3. Informational messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9. Product disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9.2. Passing the product on to another user . . . . . . . . . . . . . . . . . . . . . . . .
9.3. Final disposal of the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9.4. Disposal of patient accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9.5. Disposal of the Sonalleve QA Phantom . . . . . . . . . . . . . . . . . . . . . . . .
10. Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1. Using the air pump with air bags and vacuum cushions . . . . . . . . . .
10.2. Temperature conversion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.3. Comparing thermal dose volumes and non-perfused volumes . . . . .
10.3.1. Estimating thermal dose volumes . . . . . . . . . . . . . . . . . . .
10.3.2. Calculating non-perfused volumes (NPV) . . . . . . . . . . . . .
10.3.3. Estimating NPV on Sonalleve console . . . . . . . . . . . . . . .
10.4. QA Test result table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.5. Copying Sonalleve MR-HIFU treatment data to DVD . . . . . . . . . . . . .
10.5.1. Copying DICOM images . . . . . . . . . . . . . . . . . . . . . . . . . .
10.5.2. Copying saved state data . . . . . . . . . . . . . . . . . . . . . . . . .
10.6. Security and privacy features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.6.1. Access control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.6.2. Audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.6.3. Network time synchronization . . . . . . . . . . . . . . . . . . . . . .
10.6.4. Other Security and Privacy features addressed . . . . . . . .
10.7. Hospital administrator and user accounts . . . . . . . . . . . . . . . . . . . . .
10.7.1. About accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.7.2. Creating a new user/administrator account . . . . . . . . . . . .
10.7.3. Deleting an account . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.8. Features for advanced users and administrators . . . . . . . . . . . . . . . .
10.8.1. Partial standalone modes . . . . . . . . . . . . . . . . . . . . . . . . .
10.8.2. Changing the Site Default Configuration . . . . . . . . . . . . . .
10.8.3. Automatic backup of configuration changes in Research
mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.9. Advanced maintenance procedures . . . . . . . . . . . . . . . . . . . . . . . . . .
10.9.1. Adding water to DISCfill . . . . . . . . . . . . . . . . . . . . . . . . . .
10.9.2. Removing air from the filling hose . . . . . . . . . . . . . . . . . . .
10.10. Error and Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.11. Legal notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.11.1. Profound REACH statements . . . . . . . . . . . . . . . . . . . . .
Table of contents > Table of contents
Instructions for Use
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1. Introduction to Sonalleve MR-
HIFU
1.1. About Sonalleve MR-HIFU
The Sonalleve MR guided High Intensity Focused Ultrasound (MR-HIFU) System has the following
therapeutic application:
MR guided treatment of desmoids
Sonalleve MR-HIFU is designed to be used with Philips MR scanners.
The use of MR-HIFU requires the following equipment:
Achieva 1.5 T/3.0 T or Ingenia 1.5 T/3.0 T MR scanner.
Sonalleve MR-HIFU system.
This manual will guide you in the use of the Sonalleve MR-HIFU system. In addition, all the
instructions and safety precautions for the MR scanner apply when working with the Sonalleve MR-
HIFU system. For more information, refer to the MR scanner's Instructions for Use.
1.2. About this manual
This manual applies to the following MR-HIFU system configurations:
SONALLEVE MR-HIFU V2 ACHIEVA 1.5T
SONALLEVE MR-HIFU V2 ACHIEVA 3T
SONALLEVE MR-HIFU V2 INGENIA 1.5T
SONALLEVE MR-HIFU V2 INGENIA 3T
This manual provides information on the correct and safe use of the Sonalleve MR-HIFU system.
These Instructions for Use are intended to assist users in the safe and effective operation of the
product described.
Before attempting to operate the system, you must read these Instructions for Use, noting and
strictly observing all WARNINGS and CAUTION notices.
Pay special attention to all the information given and procedures described in 2. Safety.
The intended use and standards compliance of the Sonalleve MR-HIFU product are described
in 1. Introduction to Sonalleve MR-HIFU. This chapter also explains the textual conventions
used in this manual.
The safety aspects of using the Sonalleve MR-HIFU system are described and important
instructions for the safe use of the product are given in 2. Safety.
An overview of the system components is given in 3. System overview.
The key terms and concepts related to working with Sonalleve MR-HIFU and an outline of the
different treatment methods are provided in 4. Treatment methods.
The basic organization and functions of the User Interface are explained in 5. User interface.
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You are guided through the entire treatment workflow from system and patient preparation to
post-treatment check-ups in 6. Workflow.
Regular daily, weekly and monthly maintenance instructions for ensuring reliable and fault-free
operation of the system are provided in 7. Maintenance.
The error and warning messages are described in 8. System Error and Warning messages.
For information on the safe and environmentally sound disposal of the product, refer to 9.
Product disposal.
Additional information on certain topics is provided in 10. Appendices.
These Instructions for Use describe the most extensive configuration of the product, with the
maximum number of options and accessories. Not every function described may be available on
your product.
Important
Apart from this manual, Profound Medical also produces a Technical Description (in English
only). It provides additional data essential for safe operation and the measures or
conditions necessary for installing the Sonalleve MR-HIFU system for use with the MR
scanner.
1.2.1. Notations
WARNING
A WARNING alerts you to a potential serious outcome, adverse event or safety hazard.
Failure to observe a warning may result in death or serious injury to the user or patient.
CAUTION
A CAUTION alerts you to where special care is necessary for the safe and effective use of
the product.
Failure to observe a caution may result in minor or moderate personal injury or damage to
the product or other property, and possibly in a remote risk of more serious injury, and/or
may cause environmental pollution.
NOTICE
NOTICES highlight unusual points as an aid to the user.
WARNINGS and CAUTIONS in this Instructions for Use are each marked with one of the following
symbols, according to the cause of the safety hazard or the potential outcome:
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General symbol for WARNINGS and CAUTIONS
Crushing of hands
Electricity
Laser beam
Magnetic field
1.3. Intended use
This Profound Medical product is intended to be installed, used and operated only in accordance
with the safety procedures and operating instructions given in this Instructions for Use for the
purpose for which it was designed. The purpose for which the product is intended is given below.
However, nothing stated in this Instructions for Use reduces users’ responsibilities for sound clinical
judgment and best clinical procedure.
The Sonalleve MR-HIFU Desmoid Application is indicated for management of benign desmoid
tumors.
The system is designed to be used on patients with no MR contraindications and that fulfill the
criteria for treatment as indicated in 2.2. Contraindications and restrictions and in 2. Safety.
Installation, use and operation of this product is subject to the law in the jurisdiction in which the
product is being used. Users must only use and operate the product in such ways that do not
conflict with applicable laws, or regulations, which have the force of law.
Uses of the product for purposes other than those intended and expressly stated by the
manufacturer, as well as incorrect use or operation, may relieve the manufacturer (or its agent)
from all or some responsibility for resultant non-compliance, damage or injury.
The intended use is subject to regulatory approval and can have country-specific limitations.
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CAUTION
In the United States of America:
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
NOTICE
This Sonalleve MR-HIFU System is NOT intended for diagnostic imaging. Several image quality
and other performance compromises have been made, which make this system inadequate for
general diagnostics.
1.3.1. Sonalleve Desmoid Application
The Sonalleve MR-HIFU Desmoid Application is intended for management of benign desmoid
tumors. The desmoid tumors to be treated must be visible on MR imaging and accessible to HIFU
therapy.
Adverse Effects
Although the MR-HIFU treatment of desmoids is generally safe and often causes the patient little or
no pain, potential adverse effects have been reported in literature. Most of these effects are
transitory and can be avoided with careful treatment planning.
This list of adverse effects and the estimates on their frequency of occurrence are based on reports
in literature. References to the relevant literature will be supplied on request by your local Profound
Medical application support representative.
Tab. 1: Potential adverse effects of MR-HIFU treatment, Desmoid application.
Frequency Occurrence in
patients
Source Adverse effects
Potential transitory
effects
~ 30% of
patients
HIFU Nausea or vomiting
Pain
First degree skin burns
Fever
Tenderness near the treatment area
Less frequent
transitory effects
< 10% of
patients
HIFU Second degree skin burns
Swelling
Thermal injury to internal tissue
Catheter Urinary difficulty
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Very rare effects < 3% of
patients
HIFU
Third degree skin burns
Nerve injury or damage
Injury to organs near the
treatment area
Pain not reacting to drugs
Skin infections
Gadolinium Adverse drug reaction to Gadolinium
Catheter Urinary symptoms, such as infection
or hematuria
Other infections
Fever caused by infection
Bleeding
Exceptional effects < 1% of
patients
HIFU Metabolic imbalance (Tumor Lysis
Syndrome)
1.4. Operator profile
The Sonalleve MR-HIFU operator can be a person with professional qualifications for and
experience in MR imaging. All operators treating patients with Sonalleve MR-HIFU must have
received training by Profound Medical in the safe use of the system.
In addition, hospital technicians, clinical scientists, application specialists and service personnel
who have attended Sonalleve MR-HIFU training may use the system for testing, upgrades,
maintenance and routine Quality Assurance (QA). For more information, see 7. Maintenance.
1.5. Compatibility
The Sonalleve MR-HIFU System is available for Philips Achieva and Ingenia MR scanners.
The product described in this manual should not be used in combination with other products or
components unless such other products or components are expressly recognized as compatible by
Profound Medical. A list of such products and components is available from Profound Medical.
The other products and components that may be used with the system may each have their own
Instructions for Use.
Changes and/or additions to the product should only be carried out by Profound Medical or by third
parties expressly authorized by Profound Medical to do so. Such changes and/or additions must
comply with all applicable laws and regulations that have the force of law within the jurisdiction(s)
concerned, and with best engineering practice.
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WARNING
Changes and/or additions to the product that are carried out by persons without the
appropriate training and/or using unapproved spare parts may lead to the Profound Medical
warranty being voided.
As with all complex technical products, maintenance by persons not appropriately qualified
and/or using unapproved spare parts carries serious risks of damage to the product and of
personal injury.
1.6. Compliance
The Profound Medical Sonalleve MR-HIFU system complies with relevant international and
national standards and laws. Information on compliance will be supplied on request by your local
Profound Medical representative.
1.7. Training
Users of this product must have received adequate training on its safe and effective use before
attempting to operate the product described in this Instructions for Use. Training requirements for
this type of device will vary from country to country. Users must make sure they receive adequate
training in accordance with local laws or regulations.
If you require further information about training in the use of this product, please contact your local
Profound Medical representative.
1.8. Installation instructions
The installation instructions for the Sonalleve MR-HIFU system are supplied by Profound Medical
in separate documentation.
The installation must only be performed by appropriately trained personnel. Profound Medical can
only accept responsibility for basic safety, reliability and performance, if:
Qualified personnel carry out assembly operations, extensions, readjustments or repairs,
The electrical installation of the technical room complies with the appropriate requirements, and:
The Sonalleve MR-HIFU system is used in accordance with the Instructions for Use.
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1.9. System classification
According to the classification in the international/European standard IEC/EN 60601-1:
Tab. 2: Equipment classification.
EQUIPMENT CLASSIFICATION
Classification according to IEC 60601-1, Medical electrical equipment
Protection against electrical shock System: Class 1 Medical Electrical Equipment.
Applied parts: type BF.
Protection against harmful ingress of
water or particulate matter
Ordinary equipment (enclosed equipment without
protection against ingress of water, IPX0).
Methods of sterilization or
disinfection
Not intended to be sterilized. Use of liquid surface
disinfectants only.
Mode of operation Continuous operation.
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2. Safety
2.1. General safety
Carefully read the safety instructions and always observe them when working with the Sonalleve
MR-HIFU equipment. Failure to follow appropriate safety measures may lead to injuries to the
patient or personnel, or damage to the equipment.
Make sure that all of the electrical and mechanical assemblies and parts of the Sonalleve MR-HIFU
system are used with care and routinely inspected according to the instructions in this manual.
WARNING
Do not use the product for any application until you are sure that the user routine-checks
have been satisfactorily completed, and that the periodic maintenance of the product is up
to date. If any part of the product is known (or suspected) to be defective or wrongly
adjusted, DO NOT USE the product until a repair has been made.
Operation of the product with defective or wrongly adjusted components could expose the
user or the patient to safety hazards. This could lead to fatal or other serious personal
injury, or to clinical mistreatment.
Make sure that all personnel who use the equipment:
Are instructed in the proper usage of the equipment hardware and software.
Are aware of the limitations in the performance of the hardware and software.
Are aware of and observe all warnings and cautions that appear in this manual.
Are aware of the safety issues, instructions and limitations listed in this manual.
Are familiar with the MR scanner’s Instructions for Use as well as other manuals provided with
the MR imaging systems.
Before using the Sonalleve MR-HIFU system with a MR scanner, you should have a basic
knowledge of the MR system and its performance.
WARNING
Do not use the product for any application until you have read, understood and know all the
safety information, safety procedures and emergency procedures contained in this SAFETY
section.
Operation of the product without a proper awareness of how to use it safely could lead to
fatal or other serious personal injury. It could also lead to clinical mistreatment.
WARNING
Do not use the product for any application until you have received adequate and proper
training in its safe and effective operation. If you are unsure of your ability to operate this
product safely and effectively DO NOT USE IT.
Operation of this product without proper and adequate training could lead to fatal or other
serious personal injury. It could also lead to clinical mistreatment.
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WARNING
Do not operate the product with patients unless you have an adequate understanding of its
capabilities and functions.
Using this product without such an understanding may compromise its effectiveness and/or
reduce the safety of the patient, you and others.
WARNING
Never attempt to remove, modify, or over-ride or frustrate any safety features on the
product.
Interfering with safety features could lead to fatal or other serious personal injury.
WARNING
Do not use the product for any purpose other than those for which it is intended. Do not use
the product with any product other than that which Profound Medical recognizes as
compatible.
Operation of the product for unintended purposes, or with an incompatible product, could
lead to fatal or other serious injury. It could also lead to clinical mistreatment.
WARNING
No part of the system may be serviced or maintained while in use with a patient.
An attempt to service or maintain the system during treatment could lead to fatal or other
serious injury. It could also lead to clinical mistreatment.
WARNING
There is a Configuration Editor included in the HIFU Service tools that is intended for
qualified service personnel only, changing configurations may compromise patient safety
and cause problems in the operation and performance of the Sonalleve MR-HIFU system.
Never change the configurations without first consulting the Profound Medical Service
organization.
WARNING
Never expose volunteers to acoustic energy. Even low power ultrasound exposures may
cause tissue heating or other damage. To avoid unintended ultrasound exposures in
training sessions with volunteers, either make sure that the Sonalleve MR-HIFU system is
switched OFF, or that the ultrasound beam path is blocked with an absorption pad, or a
large positioning pad and a towel (see 7.5. Ultrasound protection for details). Do not
sonicate the absorption pad or the large positioning pad on purpose.
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When using the system for volunteer scanning, place another thin positioning pad, a thick towel or
cloth on top of the protectively used large positioning pad or absorption pad to prevent skin contact.
Do not place the absorption pad or the large positioning pad in the ultrasound beam, the pads can
become burning hot if exposed to ultrasound.
CAUTION
In training and QA sessions, only sonicate a QA phantom or other absorbing material that is
in good contact with the ultrasound window.
Acoustic energy may be reflected from unsuitable targets and interfaces such as the liquid-
air interface. The reflected energy may damage the transducer in seconds. See also 7.5.
Ultrasound protection. Do not sonicate a positioning pad on purpose.
2.2. Contraindications and restrictions
This Profound Medical product should not be used if any of the following contraindications exist or
are thought to exist:
MR contraindications specified in the MR scanner's Instructions for Use.
MRI contrast agent contraindications.
The treatment of desmoid tumors may require anesthesia or sedation. Additional
assessment is required for eligibility to anesthesia or sedation.
Scars that cannot be protected or surgical clips, implants, or prosthesis in the planned path
of the ultrasound beam
Target <1 cm from growth plate, nerve plexus, spinal canal, bladder, bowel, or other
sensitive structures or organs
Inability to tolerate stationary position for the duration of the procedure
Patient's weight > 140 kg (308 pounds)
NOTICE
If the evaluation of the patient’s clinical situation by a physician knowledgeable of HIFU suggests
that the foreseeable treatment benefits outweigh the possible risks, the patient should be informed
about the risks and benefits and his or her consent recorded according to the local practices.
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WARNING
Because the patient may have to lie immobile for several hours during the treatment,
identify the patients with a high risk or a history of deep vein thrombosis or a similar
condition potentially affected by the long immobilization and evaluate the risks and benefits
before the treatment.
NOTICE
If the physician's evaluation indicates that the patient is in the risk group, the risk and benefits
should be explained to the patient.
2.3. Heat and Specific Absorption Rate (SAR)
WARNING
Make sure that sufficient cooling is provided during the treatment and monitor patients with
insufficient cardiac functions.
Failure to do so may result in excessive heating and hyperthermia.
NOTICE
If the physician's evaluation indicates that the patient is in the elevated risk group, the rationale for
cooling should be explained to the patient.
WARNING
When the ultrasound transducer is sonicating (emitting acoustic energy), there is a blue
sonication indicator light in the liquid container. Never put body parts into the ultrasound
field as internal tissue heating and damage may occur in seconds.
2.3.1. Specific Absorption Rate (SAR)
Both the MR system and the Sonalleve MR-HIFU system produce thermal energy, which is
absorbed by the patient during treatment. The International/European standard IEC/EN 60601-2-33
Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis
defines limits for the acceptable tissue and body temperature rise caused by the Specific
Absorption Rate (Definition of SAR see: IEEE C.95.1-1999) of radio frequency power per unit mass
of an object. The standard sets limits for the maximum allowed rise of the patient's core
temperature. The MR scanner achieves compliance with these requirements by controlling the
SAR of the MR protocols.
The SAR limits of the MR scanner are defined for conditions with a specific room temperature
24 °C (75.2 °F) and humidity 60% and minimal air flow. In addition, the patient is assumed to be
lightly clothed. The standard uses 6 minutes as the averaging period for determining the SAR for
all tissues. For a detailed description of the SAR operating modes and temperature and humidity
levels, see the MR scanner's Instructions for Use and the standard IEC/EN 60601-2-33.
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2.3.2. Specific Energy Dose (SED)
The amount of radio frequency (RF) energy absorbed by the body, per unit mass, is called the
Specific Energy Dose (SED). The SED is determined by the SAR and scan duration. The SED is
expressed in kJ/kg.
NOTICE
In some MR imaging protocols the total SED can become so high that it limits the use of the
protocol.
2.3.3. Heat load induced by ultrasound
Also the ultrasound energy delivered to the patient is ultimately absorbed and transformed to
thermal energy inside the patient.
The total thermal energy over the course of the treatment can be reduced by:
Using feedback cells instead of regular cells.
Using larger treatment cells.
Short term heat load over the course of a few minutes can be reduced by:
Increasing the cooling interval between sonications.
Using smaller treatment cells.
Note that increasing the cooling interval between sonications increases the total treatment time.
2.3.4. Cooling the patient
WARNING
Always leave sufficient cooling intervals between sonications.
Failure to do so may cause heat buildup in the near field or far field, leading to skin burn or
other unwanted tissue damage.
The system visualizes temperature changes relative to the start of each sonication, not absolute
temperature. Estimates of heat buildup and predictions of cumulative heating in the near field are
calculated internally and affect cooling times.
NOTICE
Refer to 4.5. Temperature monitoring for more information on the temperature measurement
method and to 4.5.4. Cooling time for more information on cooling time.
The Sonalleve MR-HIFU systems include an active Direct Skin Cooling (DISC) device. The
purpose of the device is to facilitate faster tissue cooling by keeping the patient interface at a
constant temperature throughout the treatment. This effect is taken into account when the system
calculates cooling time recommendations. In most cases, active cooling will shorten the system-
recommended cooling times. Thus using the DISC device may shorten the total treatment time.
The operational status of DISC is displayed in the System Status Display (see 5.9.1. System Status
Display).
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2.3.5. Clothing and environmental conditions
Refer to the MR scanner’s Instructions for Use.
WARNING
The whole body SAR limits are only valid for room temperatures not greater than 24 °C
(75.2 °F) and relative humidity not greater than 60%.
2.4. Contrast agents and medication
If preliminary images with contrast agents are needed, make sure these are obtained well before
the actual treatment as contrast agents cannot be used in the HIFU treatment.
WARNING
The HIFU treatment may affect the chemical and physiological properties of certain
chemicals used in drugs. Make sure that the patient has been screened for such chemicals
and drugs.
WARNING
Never administer Gadolinium-based contrast agents to the patient before treatment.
Certain Gadolinium-based compounds (such as contrast agents) may decompose when
sonicated, producing dangerous or poisonous compounds. The exact time period that must
be left between a contrast agent scan and the HIFU treatment cannot be defined as it
depends on the specific drug and the metabolism of the patient.
The following MRI contrast agents are Gadolinium-based and may decompose when sonicated.
This list may not be exhaustive.
Gadobenate (MultiHance®)
Gadobutrol (Gadovist®, Gadavist®)
Gadocoletate
Gadodenterate
Gadodiamide (Omniscan®)
Gadofosveset (Ablavar®, Vasovist®)
Gadomelitol (Vistarem®)
Gadopenamide
Gadopentetate (Magnevist®)
Gadoterate (Dotarem®)
Gadoteridol (ProHance®)
Gadoversetamide (Optimark™)
Gadoxetate (Eovist®, Primovist®)
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2.5. Emergency Stop and Safety Devices
There are three abort mechanisms in the Sonalleve MR-HIFU system:
Patient Emergency Stop Button (PESB) for the patient.
A Stop button in the Safety Device for the user.
An abort button in the user interface.
WARNING
Use the Safety Device Stop button or PESB immediately in a hazardous situation. Use the
software abort button to stop the sonication in situations that do not present any hazard (if,
for example, the treatment is deemed sufficient before the planned treatment time is
reached).
2.5.1. Patient Emergency Stop Button (PESB)
The patient can stop the treatment at any point by pressing the Patient Emergency Stop Button
(PESB). Pressing the PESB terminates the sonication immediately, although scanning of the
temperature maps continues. As the patient presses the button, an indicator light is switched on in
the device, there is a beep sound in the MR room and in the operator's Safety Device, and the
Sonalleve Console displays an error. Always instruct the patient about the correct usage of the
PESB prior to the start of the treatment. If the patient has stopped the treatment because of pain,
analyze the cause of pain before continuing the treatment.
When the patient presses the PESB, the red indicator light in the Safety Device is switched on. No
further sonications are possible, before the user presses the green Enable button in the Safety
Device.
During pre-treatment scanning, and when sonication is not on, the PESB functions like the MR
nurse call button: it gives an audio signal but does not stop scanning.
WARNING
Do not use the standard MR Nurse Call button with the Sonalleve MR-HIFU system. Use the
Patient Emergency Stop Button (PESB) instead.
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