Manufacturer's Emc Declaration - Zimmer CITrac Instructions For Use Manual

Manufacturer´s EMC declaration
With regards to the EMC (electromagnetic compatibility), medical electrical devices such
are subject to special safety measures and must be installed and commissioned in accordance with the
EMC instructions in the operating instructions or accompanying documents.
The product fulfils the requirements of IEC 60601-1-2:2014
Portable and mobile RF communications equipment (e.g mobile telephones, cell phones) can impact
medical electrical devices.
The clTrac may only be operated using the original power cable indicated in the scope of delivery list.
Operating the device with another power cable can lead to increased emissions or reduced interference
resistance of the device!
Guidelines and manufacturer declaration - electromagnetic emitted interference
The clTrac device is intended for operation in an electromagnetic environment as indicated below. The clTrac
customer or user should ensure that it is operated in such an environment.
Emitted interference
Terminal Disturbance Voltage
Radiated Emissions
Harmonic emissions
Voltage fluctuations / flicker emissions
The device must not be used directly next to or stacked on/under other
devices. If operation near or stacked on/under other devices is necessary, the
device should be observed to check for proper operation in this setup.
Basic standard
CISPR 11:2009 +A1:2010
CISPR 11:2009 +A1:2010
IEC 61000-3-2:2005 +A1:2008 +A2:2009
IEC 61000-3-3:2013
18
-
as the clTrac
Compliance level
Class B, Group 1
Class B, Group 1
Class A
IEC 61000-4-15 for 10
minutes max 4%
Page 32