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Mobile X-ray Unit
Operation
28
It is customer/owner responsibility to assure that this
equipment and vicinity equipment complies the value of
radio frequency interferences shown in General Regulation
for
safety
according
IEC 60601-1-2:2014 Tables as described in this section.
The manufacturer is not responsible for any interference
caused by using other than recommended interconnect
cables or by unauthorized changes or modifications to this
equipment.
ESSENTIAL PERFORMANCE
The system is designed to use X-rays for diagnostic purposes. The system (e.g.
Tube, Detector, Generator and Patient Support) is designed according to
international standards, to prevent patient, user, and others from electrical and
mechanical hazards by using adequate EMC measures like using filters,
screened cables or housings.
EMC-COMPLIANCE CRITERIA DUE TO THE ESSENTIAL PERFORMANCE
No unintended movement
No unintended X-radiation
No unintended change of generator parameters (kV, mAs)
to
IEC 60601-1-2:
2007
and
OM-0481R1
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