TruNode
®
Gamma Probe System User Manual
22
11.
EMC DECLARATION
This product has been tested and verified to ensure that there are no
issues or concerns regarding reciprocal interference. This includes
EMI, EMC and RF. It has been certified and tested by 3rd party
testing facilities. List of standards is as follows:
•
Medical Electrical Equipment - Part 1: General Requirements For
Safety - Collateral Standard: Electromagnetic Compatibility -
Requirements and Tests
–
EN 60601-1-2:2014
•
CFR 47, Part 15, Section 15.247 (b): Effective Isotropic Radiated
Power (EIRP)
•
CFR 47, Part 15, Section 15.247 (d): Spurious Emissions
•
EMC Directive 2004/108/EC Group l, Class B
•
Radio Equipment Directive 1999/5/EC
The TruNode® Gamma Probe System needs special precautions
regarding EMC and needs to be installed and put into service according
to the EMC information provided in this User Manual. The customer or
user of the TruNode® Gamma Probe System should assure that it is
used in such an environment. The following tables provide a guidance
and declaration for the electromagnetic emissions and immunity of the
TruNode® Gamma Probe System which requires the use of the
supplied TruNode® Power Supply. The use of components other than
these may result in increased emissions or decreased immunity.
Similarly, the use of the supplied Power Supply and Cable with
equipment and systems other than the TruNode® Gamma Probe
System may significantly degrade emissions and immunity and result in
improper operation.
Portable and mobile RF communications equipment can degrade the
performance of the TruNode® Gamma Probe System, and should be
used no closer than 30cm (12 inches) to any part of the system.
