Siemens MAGNETOM Skyra, Owner'S Manual, Page: 14 / 124

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Safety instructions
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MAGNETOM Family - Safety Information
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Legal regulations
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Country-specific regulations
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Local and national legal regulations must be observed. It is the
operator’s responsibility to follow local statutory requirements
regarding access to the controlled access area.
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The local regulations also define the acceptable exposure limits
regarding noise as well as magnetic stray fields for users and
patients. (
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System Owner Manual: Technical data)
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National guidelines
(for Germany)
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The following regulations are in effect in Germany:
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Medical Devices Act (MPG)
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Electromagnetic Device Compatibility Act (EMVG)
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Medical Device Operator Regulations (MPBetreibV)
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Accident Prevention Regulations (UVV)
If required, the RF source must be registered with local authori-
ties in accordance with national EMC guidelines.
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Pressure Equipment Direc-
tive
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The super-conductive magnet is classified as pressure equip-
ment. National guidelines for starting up and operating pres-
sure equipment must be observed.
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In Europe, the Pressure Equipment Directive (97/23/EG) regu-
lates the sale of pressure devices.
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In Germany, both the Pressure Equipment Directive as well as
the relevant Occupational Safety Regulations (BetrSichV) for
system start-up and operation apply.
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