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Therapy EC | User’s Manual
BIOCOMPATIBILITY
The part applied, that touches the patient, is in accordance with the requirements of the ISO 10993-1.
CALCULATION OF BEAM DIVERGENCE
Laser Emission
Applied Standard: 60825-1:2014 / Subclause 3.13
The beam divergence for 1000 µm fiber is 0,45 rad ± 0,03 rad.
EQUIPMENT ELECTROMAGNETIC SAFETY STANDARDS
Find below the tables which represent the adequacy to emission and electromagnetic immunity
standards.
Manufacturer standards and declaration - Electromagnetic Emissions - for every equip-
ment and system [IEC 60601-1-2 / 2007 - subcl. 6.8.3.201 a) 3)]
Therapy EC is designated to be used in electromagnetic environment specified below. Therapy EC’
customer or user shall ensure it will be used in such environment.
Immunity test Compliance Electromagnetic Environment -Standard
RF emissions
ABNT NBR IEC CISPR 11
Group 1
Compliance
Therapy EC uses RF energy only for internal
functions. So, its RF emissions are very low and
it is not likely to cause any interference to close
electronic equipment.
RF emissions
ABNT NBR CISPR 11
Class “A”
Therapy EC can be used at all establishments
which are not designated for domestic use or
which are not directly connected to a public
low-tension energy supply network which feeds
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Emissions due to voltage fluc-
tuation/flicker
IEC 61000-3-3
Not applicable
Table 1: Information regarding compliance to the requirements for electromagnetic emission based
on Table 201 - 60601-1-2, 2007.
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