Safety; General Safety - Profound Sonalleve MR-HIFU Instructions For Use Manual

2. Safety > 2.1. General 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.
Instructions for Use
109745C2 / 02-2022

2. Safety

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