Instructions For Use; Legal Notices; Profound Reach Statements - Profound Sonalleve MR-HIFU Instructions For Use Manual

Table of Contents

10. Appendices > 10.11. Legal notices

Sonalleve MR-HIFU - Instructions for Use

Published by Profound Medical

Profound Medical reserves the right to make changes to both this Instructions for Use and to the

product it describes. Product specifications are subject to change without notice. Nothing contained

within this Instructions for Use is intended as any offer, warranty, promise or contractual condition,

and must not be taken as such.

All rights are reserved. Reproduction in whole or in part in any form or by any means, electrical,

mechanical or otherwise is prohibited without the written consent of the copyright holder.

Unauthorized copying of this publication may not only infringe copyright and reduce the ability of

Profound Medical to provide accurate and up-to-date information to users.

Non Profound Medical product names may be trademarks of their respective owners.

Published in Canada

REACH requires Profound Medical to provide chemical content information for Substances of Very

High Concern (SVHC) if they are present above 0.1% of the article weight. The QA Phantom 4510

000 82232 for Sonalleve MR-HIFU systems may contain acrylamide (CAS nr.: 79‑06‑1) more than

0.1% but less than 0.25% of the phantom weight.

REACH requires Profound Medical to provide chemical content information for Substances of Very

High Concern (SVHC) if they are present above 0.1% of the product weight. Components within

electric and electronic equipment may contain phthalates above the threshold (e.g. bis(2-

ethyl(hexyl)phthalate), CAS nr.: 117-81-7).

Instructions for Use

109745C2 / 02-2022

192 (192)

Table of Contents