Zimmer OptonPro - Manufacturers EMC Declaration; Electromagnetic Emissions Guidance

Manufacturer's EMC declaration
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Medical electrical devices such as OptonPro are subject to special precautions with regard to electromagnetic compatibility
(EMC) and must be installed and commissioned in accordance with the EMC instructions given in the operating instructions
and accompanying documents.
Portable and mobile RF communications devices (such as mobile phones) may interfere with medical electrical devices.
OptonPro should only be operated with the original parts specified in the delivery and accessories list. Operation of the
device with accessories other than those specified may result in increased emissions or decreased immunity of the device.
Guidance and manufacturer's declaration – electromagnetic emissions
OptonPro is intended for operation in one of the electromagnetic environments specified below. The customer or
user of the OptonPro should ensure that it is operated in such an environment.
Interference emissions tests
Compliance
Electromagnetic environment – guideline
RF emissions CISPR 11
Group 2
The OptonPro must emit electromagnetic
energy to perform its intended function.
Nearby electronic equipment may be affected.
RF emissions CISPR 11
Class B
The OptonPro is suitable for use in facilities
other than those used for residential
purposes, and in those directly connected to
the public low-voltage power supply network
that supplies buildings used for residential
purposes, subject to the following warning
being observed:
Warning: This device is exclusively for use by
qualified medical personnel. It is a class A
device or system as per CISPR 11. In areas
used for residential purposes, the device or
system may cause radio interference, which
may require suitable measures, such a
different alignment, different setup or shielding
of the OptonPro or filtering the connection to
the site.
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuation emissions and flicker
IEC 61000-3-3
Complies
Table 201 as per EN 60601-1-2:2006-10
The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the
device should be monitored to verify normal operation in the configuration in which it will be used.