5352
Immunity Test Summary
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The NOMAD Pro 2 Intraoral X-ray System is intended for use in the electromagnetic environment specified
below. The customer or user of the NOMAD Pro 2 Intraoral X-ray System should ensure 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
+/-8 kV contact
+/-15kV air
+/-2, 4, 6 & 8kV
contact
+/-2, 4, 8, & 15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are synthetic, the
r/h should be at least 30%
Electrical fast
Transient/burst
IEC 61000-4-4
+/-2 kV for
power supply lines
+/-1 kV for input/
output lines
+/-0.5, 1 & 2 kV for
power
supply lines
+/-0.5 & 1 kV for
input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+/-1 kV
differential mode
+/-2 kV common
mode
+/-0.5 & 1 kV
differential mode
+/-0.5, 1 & 2 kV
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
100 % Dip; for 0,5
cycles
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
60% Dip for
1 Cycle
30% Dip for
25 Cycles
100% Dip for
5 Seconds
100 % Dip for 0,5
cycles
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
60% Dip for
1 Cycle
30% Dip for
25 Cycles
100% Dip for
5 Seconds
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
NOMAD Pro 2 Intraoral X-ray System
requires continued operation during
power mains interruptions, it is
recommended that the NOMAD Pro
2 Intraoral X-ray System be powered
from an uninterruptible power supply
or battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30A/m 3 & 30A/m
Power frequency magnetic fields should
be that of a typical commercial or
hospital environment.