Emc Declaration - Zimmer Cryo 6 Instructions For Use Manual

Manufacturer´s EMC declaration
Medical electrical devices, such as Cryo 6, 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.
Cryo 6 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 Cryo 6 device is intended to be operated in an electromagnetic environment as indicated below. The customer
or user of the Cryo 6 should ensure that it is operated in such an environment.
Interference emission measurements
HF emissions according to CISPR 11
HF emissions according to CISPR 11
Harmonic emissions according to IEC
61000-3-2
Voltage fluctuations/flickers according to
IEC 61000-3-3
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.
Compliance Electromagnetic environment - Guideline
Group 1 The Cryo 6 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.
Class B The Cryo 6 device is suitable for use in all
facilities, including those in a residential area,
Class A
and in those which are connected directly to
the public grid which also supplies buildings
used for residential purposes.
not applicable
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