Information About Electromagnetic Compatibility (Emc); Standards/Regulations - Compex COREBELT 5.0 Bedienungsanleitung

EN

INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY (EMC)

The stimulator is designed to be used in typical domestic environments approved in accordance with the safety
standard EMC EN 60601-1-2.
This device emits very low levels in the radio frequency (RF) interval and is therefore not likely to cause
interference with nearby electronic equipment (radios, computers, telephones, etc.).
The stimulator is designed to withstand foreseeable disturbances originating from electrostatic discharge,
magnetic fields from the power supply or radio frequency emitters.
However, it is not possible to guarantee that the stimulator will not be affected by powerful RF (radio frequency)
fields originating, for example, from mobile phones.
For more detailed information about electromagnetic emissions and immunity, please contact Compex.
The stimulator complies with part 15 of the FCC Rules.

STANDARDS/REGULATIONS

To ensure your safety, the stimulator has been designed, manufactured and distributed in accordance with the
requirements of the amended EU Medical Device Regulation MDR 2017/745 covering medical devices and the
FDA 21 CFR 820 21 CFR Part 820 – Quality system regulation.
It complies also to 60601-1, 60601-2-10, 60601-1-11, 60601-1-6, 60601-1-2 standards.
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