Clothing And Environmental Conditions; Contrast Agents And Medication - Profound Sonalleve MR-HIFU Instructions For Use Manual

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2. Safety > 2.4. Contrast agents and medication

2.3.5. Clothing and environmental conditions

Refer to the MR scanner's Instructions for Use.
WARNING
The whole body SAR limits are only valid for room temperatures not greater than 24 °C
(75.2 °F) and relative humidity not greater than 60%.

2.4. Contrast agents and medication

If preliminary images with contrast agents are needed, make sure these are obtained well before
the actual treatment as contrast agents cannot be used in the HIFU treatment.
WARNING
The HIFU treatment may affect the chemical and physiological properties of certain
chemicals used in drugs. Make sure that the patient has been screened for such chemicals
and drugs.
WARNING
Never administer Gadolinium-based contrast agents to the patient before treatment.
Certain Gadolinium-based compounds (such as contrast agents) may decompose when
sonicated, producing dangerous or poisonous compounds. The exact time period that must
be left between a contrast agent scan and the HIFU treatment cannot be defined as it
depends on the specific drug and the metabolism of the patient.
The following MRI contrast agents are Gadolinium-based and may decompose when sonicated.
This list may not be exhaustive.
Gadobenate (MultiHance®)
Gadobutrol (Gadovist®, Gadavist®)
Gadocoletate
Gadodenterate
Gadodiamide (Omniscan®)
Gadofosveset (Ablavar®, Vasovist®)
Gadomelitol (Vistarem®)
Gadopenamide
Gadopentetate (Magnevist®)
Gadoterate (Dotarem®)
Gadoteridol (ProHance®)
Gadoversetamide (Optimark™)
Gadoxetate (Eovist®, Primovist®)
Instructions for Use
109745C2 / 02-2022
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