12.5 Information on electromagnetic compatibility
12.5.1 Minimum distances between radiated interference source and the device
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
Medical electrical devices are subject to special precautionary
measures with regard to electromagnetic compatibility (EMC).
Portable and mobile high-frequency RF communication equipment is a
source of radiated electromagnetic interference that can affect medical
electrical devices. This can lead to device malfunctions.
For this reason, a certain minimum distance must be kept between
radiated interference sources in the vicinity of running medical electrical
devices.
Warning
Patient hazard due to device malfunction
Using accessories or lines other than those specified in the Instructions
for Use can lead to increased emitted interference or reduced
interference immunity of the device.
Check the suitability of accessories and lines which are not specified
in the Instructions for Use.
Warning
Patient hazard due to possible device malfunction
A device malfunction can be caused by high-frequency electromagnetic
waves (radiated interference source).
Observe the minimum required distances for radiated interference
sources.
For further information on "Guidance and manufacturer's declaration on
EMC", refer to the Service Manual.
Chapter 12: Specifications
12-5