USER MANUAL (Instruction for Use) SW 6.1
Safety
Version 6.1.6 dated 2020-01-31 EN Page 24 of 201
Electrical Safety, Mechanical Safety, Functional Safety
The SCHWIND AMARIS excimer laser has been tested for electric, mechanical and functional
safety according to the international safety standard IEC 60601-1 (general requirements for safety
and performance of medical electrical equipment), and the conformity with the above mentioned
standard has been verified.
Electromagnetic Compatibility (EMC)
The SCHWIND AMARIS excimer laser has been tested and found to be compliant with the
Standard IEC 60601-1-2 regarding electromagnetic compatibility.
Further information on electromagnetic compatibility (EMC)
Despite adherence to all applicable EMC requirements, malfunctioning cannot be ruled out
entirely. This equipment has been tested and found to comply with the limits of IEC 60601-1-2 for
medical devices. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates uses and radiates radio
frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:
Relocate the receiving device.
Separate the equipment by increasing the distance.
Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected. Consult the manufacturer or field service engineer for assistance.
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