Notations - Profound Sonalleve MR-HIFU Instructions For Use Manual

1. Introduction to Sonalleve MR-HIFU > 1.2. About this manual
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:
Instructions for Use
109745C2 / 02-2022
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