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2. Safety > 2.6. Emergency procedures
2.5.3. Software Abort Sonication button
The Sonalleve MR-HIFU user interface provides a software Abort Sonication button for
terminating the sonication. Use the software Abort Sonication button in non-hazardous situations,
for example if the target temperature is reached in the tissue before the planned treatment time is
over.
2.6. Emergency procedures
The emergency procedures described in the chapter "Safety" in the MR scanner's Instructions for
Use apply also to Sonalleve MR-HIFU.
In a hazardous situation, terminate the HIFU treatment using the red Stop button on the Safety
Device and remove the patient from the table and the examination room.
2.7. Magnetic safety
All the equipment used in the examination room must be MR compatible. Never bring any metal
objects in the examination room.
Carefully read the warnings and follow the instructions in the MR scanner's Instructions for Use.
Static magnetic field of 1.5 T and 3.0 T
Maximum spatial field gradient of up to 4.500 gauss/cm (45 T/m)
Maximum allowable patient weight of up to 140 kg (308 pounds)
MRI scans should be conducted using the Receive-only HIFU Coils provided with the Sonalleve
System. For more on the conditions of safe use of the HIFU coils, please refer to labeling on the
coils.
2.8. Mechanical and electrical safety
Before using the Sonalleve MR-HIFU hardware components, visually check them to ensure that
they are undamaged. Especially, inspect all the wires, hoses, connectors and sockets. Patient or
operator injury could occur if these instructions are not properly followed.
Use this product in rooms or areas that comply with all applicable laws (or regulations having the
force of law) concerning electrical safety for this type of product.
For additional safety instructions, refer to the MR scanner's Instructions for Use.
WARNING
Do not remove covers or cables from this product unless expressly instructed to do so in
this Instructions for Use. Dangerous electrical voltages are present within this product.
Removing covers or cables could lead to serious or fatal personal injury.
Instructions for Use
109745C2 / 02-2022
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