Chemical Safety; Explosion Safety; Fire Safety - Profound Sonalleve MR-HIFU Instructions For Use Manual

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2. Safety > 2.10. Chemical safety

2.10. Chemical safety

The ultrasound transducer inside the Sonalleve Table Top is immersed in liquid. The liquid inside
the Table Top is in a sealed container and does not come in contact with operators or patients in
normal operation of the system. For information on how to safely handle the liquid in the event of a
leak, refer to the Material Safety Data Sheet supplied with the system.
WARNING
Usage of a damaged QA Phantom is not allowed.
The Sonalleve QA Phantom, model 4510 000 82232, contains residues of acrylamide (CAS
nr.: 79-06-1) in a hermetically sealed container. If the container is damaged or the contents
come out of the container, dispose of the phantom and the liquids that have been in contact
with the exposed contents. Use nitrile rubber gloves when disposing of the material and the
liquids. Follow the disposal instructions.
Failure to follow this instruction may expose the operator, other personnel and patients to
poisonous chemicals and result in damage to the environment.
The Sonalleve QA Phantom, model 4510 000 82232, is classified as hazardous waste based on
the classification and the concentration of acrylamide used in its filling mixture.
The QA Phantom must be disposed of according to the instructions laid out for hazardous waste
handling. See 9.5. Disposal of the Sonalleve QA Phantom.

2.11. Explosion safety

WARNING
• Do not use this product in the presence of explosive gases or vapors, such as certain
anesthetic gases.
• Do not use flammable or potentially explosive disinfecting sprays.
• Use of this product in an environment for which it was not designed can lead to fire or
explosion.

2.12. Fire safety

The use of an electrical product in an environment for which it was not designed can lead to fire or
explosion.
Fire regulations for the type of medical area being used should be fully applied, observed and
enforced. Fire extinguishers should be available for both electrical and non-electrical fires.
If it is safe to do so, attempt to isolate the product from electrical and other supplies before
attempting to fight a fire. This will reduce the risk of electric shocks.
For further information on fire safety and MR compatible fire extinguishers, refer to the MR
scanner's Instructions for Use.
WARNING
On electrical or chemical fires, only use extinguishers that are specifically labeled for those
purposes.
Using water or other liquids on an electrical fire can lead to fatal or other serious personal
injury.
Instructions for Use
109745C2 / 02-2022
22 (192)

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