Safety information for the system owner
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A.1-3
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syngo MR D13
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Electromagnetic fields
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The 0.5 mT line in the examination room defines the controlled
access area of the RF field. For controlling access to this area
adequate rules must be established. Therefore, regard the
potential risks from the attraction of magnetizable objects or
from torque on such materials. Also consider persons inadvert-
ently entering the area who may be affected by the possible dys-
function of their medical implants such as pacemakers.
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Outside the controlled access area of the RF field, electromag-
netic interferences meet the requirements according to
IEC 60601-1-2.
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Regarding the static magnetic field, your MR system is continu-
ously operated in the normal mode (means not more than
3.0 T). For China only: If the static magnetic field is higher than
2.0 T, the system is operated in the first level mode.
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The limits of exposure of MR workers to static and time-varying
magnetic fields may be regulated by local laws. Special precau-
tions are necessary for pregnant MR workers, although no epi-
demiological evidence of any negative health effects currently
exists (local laws may apply). It might be that the limits do not
apply for pregnant MR workers. Furthermore, it may be required
in some countries that the “member of the public” limit is
applied to the fetus.
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Noise development
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The exposure of MR workers to noise may be regulated by local
laws. The operator must ensure that the sound level at the oper-
ating console is limited in compliance with local rules for the
safety of the physician and the MR worker.
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For MR equipment that produces noise louder than 99 dB(A),
the sound pressure level is measured according to NEMA MS 4.
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