Table 202: Guidance and Manufacturer’s Declaration—Immunity All Equipment and Systems
Electromagnetic Compatibility (EMC) User Information
The MLX light source is intended for use in the electromagnetic environment specified below. The customer or user of the MLX
light source should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level Compliance Level
Electromagnetic Environment - Guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete or ceramic
tile. If floors are synthetic, the relative humid-
ity should be at least 30%.
Electrical Fast Transient/
burst
IEC 61000-4-4
±2kV on AC Mains ±2kV on AC Mains Mains power quality should be that of a typi-
cal commercial or hospital environment.
Note - Tests Performed at both 240VAC,
50Hz and 120VAC, 60Hz
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common
±1kV Differential
±2kV Common
Mains power quality should be that of a typi-
cal commercial or hospital environment.
Note - Tests Performed at both 240VAC,
50Hz and 120VAC, 60Hz
Voltage dips, short interrup-
tions and voltage variations
on power supply input lines
IEC 61000-4-11
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
Mains power quality should be that of a typi-
cal commercial or hospital environment. If
the user of the MLX unit requires continued
operation during power mains interruptions,
it is recommended that the MLX unit be pow-
ered from an uninterruptible power supply or
baery.
Note - Tests Performed at both 240VAC,
50Hz and 120VAC, 60Hz
Power Frequency 50/60Hz
Magnetic Field
IEC 61000-4-8
3A/m 3A/m Power frequency magnetic fields should be
that of a typical location in a typical commer-
cial or hospital environment.
Note - Tests Performed at both 50Hz and
60Hz
Integra
®
Luxtec
®
MLX 300 Wa Xenon Light Source
15