Berchtold CHROMOPHARE E 778 - Information on Electromagnetic Compatibility (EMC)111; Guidelines and Manufacturers Declaration - Electromagnetic Emissions

LED surgical lights, single and combination lights CHROMOPHARE
®
E 778, E 668, E 558
Appendix
111
15.4 Information on electromagnetic compatibility (EMC)
Electrical medical devices such as this are subject to special EMC precautions and must be installed and
put into operation in accordance with the instructions in the operating manual.
CHROMOPHARE

surgical lights are designed for use in the electromagnetic environment specified below.
The operator must ensure that the lights are used only in this environment.
15.4.1 Guidelines and manufacturer's declaration – Electromagnetic emissions
Emissions test Compliance Electromagnetic environment – Guidelines
RF emissions
per CISPR11
Class B
Harmonic emissions
per IEC 61000-3-2
Class A
Voltage fluctuations Fulfilled
CHROMOPHARE

lights are suitable for use in all
facilities, including residential areas and those
directly connected to the public power grid that
supplies residential buildings.
15.4.2 Guidelines and manufacturer's declaration – Electromagnetic interference
immunity
Immunity tests
IEC 60601 test/
compliance level
Electromagnetic environment – Guidelines
± 6 kV
contact discharge
Electrostatic discharge (ESD)
per IEC 61000-4-2
± 8 kV
air discharge
Synthetic floors should be antistatic and the relative
humidity at least 30%.
± 2 kV
for power supply lines
Electrical fast transient bursts
per IEC 61000-4-4
± 1 kV
for input and
output lines
The mains power quality should correspond to that
of a typical commercial or hospital environment.
± 1 kV
normal mode
voltage
Surges
per IEC 61000-4-5
± 2 kV
common mode
voltage
The mains power quality should correspond to that
of a typical commercial or hospital environment.