7 Technical data
FOCUS
35
7.2 EMC declaration
NOTICE!
Medical electrical equipment needs special
precautions regarding EMC and needs to be installed
according to EMC information.
IEC60601-1-2 ed4 testing has verified that electromagnetic
interference stimulus has no effect to safety critical
functionality of the device.
This includes the patient
positioning and other imaging pre-conditions, imaging
program value selection and imaging process
If abnormal performance is observed, such as degradation
of essential performance in form of reduction of line pair
resolution, additional measures may be necessary, such
as re-orienting or relocating the device.
The device is suitable for use in both at professional
healthcare (hospitals/large clinics) facility environment and
home healthcare (clinics in domestic establishments and
those directly connected to the public low-voltage power
supply) environment.
Exceptions for professional healthcare facility environment:
Not to be used or installed near active HF SURGICAL
EQUIPMENT and the RF shielded room of an ME
SYSTEM for magnetic resonance imaging, where the
intensity of EM DISTURBANCES is high.
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