Safety and Compliance 16
EMC Safety Information
The laser system (console and accessories) needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in this section. Portable
and mobile RF communications equipment can affect this system.
This laser system has been tested and found to comply with the limits for medical devices in
IEC 60601-1-2 according to the tables in this section. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation.
CAUTION: Changes or modifications to this laser system not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment and may result in increased
emissions or decreased immunity of the laser system.
EMC Requirements for Console and Accessories
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
This laser system (console and accessories) is intended for use in the electromagnetic environment specified
below. The customer or the user of the laser system should assure that it is used in such an environment.
Emissions Test
Compliance
RF emissions
CISPR 11
Group 1
The laser system uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flicker emissions
Complies
The laser system is suitable for use in all establishments, other than domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
