Use Instructions

Immunity test IEC 60601-1-2 test level Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Floors should be conductive. If floors are
covered with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
AC mains line ±2 kV, 100 kHz
repetition frequency
Signal port ±1 kV, 100 kHz repetition
frequency
Mains power quality should be that of
a typical hospital environment.
Surge
IEC 61000-4-5
±0,5 kV, ±1 kV line-to-line
Mains power quality should be that of
a typical hospital environment.
Voltage dips
IEC 61000-4-11
Single-phase mains: 0 % U
T
; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0 % U
T
; 1 cycle and
70 % U
T
; 25/30 cycles
Single phase: at 0°
Mains power quality should be that of a typical
hospital environment. If the user of this laser
system requires continued operation during power
mains interruptions longer than 45 minutes, it is
recommended that the laser system be powered
from an uninterruptible power source.
Voltage interruptions
IEC 61000-4-11
0 % UT ; 250/300 cycle
Mains power quality should be that of
a typical hospital environment.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical hospital environment.
Table 10. Electromagnetic safety – ML6710i device.
Guidance and manufacturers declaration — electromagnetic safety
The ML6710i is intended for use in the electromagnetic environment specified below. The owner/
user of this device is responsible for assuring that it is used in such an environment.
ML6710i Instructions For Use
56 Guidance and manufacturers declaration – electromagnetic emissions