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Zimmer PhySys - Manufacturers EMC Declaration

Zimmer PhySys
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Manufacturer's EMC declaration
20
Page 53
Medical electrical devices, such as PhySys, are subject to special precautionary measures with regard to EMC
(electromagnetic compatibility) and must be installed and put into operation according to the EMC information in the
instructions for use or accompanying documentation.
Portable and mobile HF communication devices (such as mobile phones, cell phones) can affect medical electrical devices.
PhySys may only be operated with the original power cable indicated in the list of the scope of delivery and accessories.
Operation of the device with a different power cable can lead to increased emissions or reduced interference immunity of the
device!
Guidelines and manufacturer's declaration – Electromagnetic emissions
The PhySys device is intended to be operated in an electromagnetic environment as indicated below. The customer
or user of the PhySys should ensure that it is operated in such an environment.
Interference emission measurements
Compliance
Electromagnetic environment - Guideline
HF emissions according to CISPR 11
Group 2
The PhySys device uses HF energy only for
its internal functioning. This means that its HF
emissions are very low, and it is very unlikely
that adjacent electronic devices would suffer
interference.
HF emissions according to CISPR 11
Class B
The PhySys device is suitable for use in all
facilities, including those in a residential area,
and in those which are connected directly to
the public grid which also supplies buildings
used for residential purposes.
Harmonic emissions according to IEC
61000-3-2
Class A
Voltage fluctuations / flickers according to
IEC 61000-3-3
Complies
Table 201 according to EN 60601-1-2:2006-10
The device should not be used in the direct vicinity of or stacked with other devices. If operation near or stacked with other
devices is necessary, the device should be observed to check its proper operation in the arrangement used.

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