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1. Introduction to Sonalleve MR-HIFU > 1.6. Compliance
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.
Instructions for Use
109745C2 / 02-2022
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