Test Standard Class / Severity level Test results
Voltage changes, Voltage
fluctuations and Flicker test
IEC 61000-3-3 230 VAC mains @ 50 Hz
& 220 VAC mains @ 50 Hz
Complies
Immunity (IEC 60601-1-2 section 8)
Immunity from Electrostatic
discharge (ESD)
IEC 61000-4-2 8 kV contact discharges &
15 kV air discharges
Complies
Immunity from radiated
electromagnetic fields
IEC 61000-4-3 10.0 V/m; 80 MHz ÷ 2.7 GHz,
80% AM, 1 kHz
Complies
Immunity from Proximity
field from wireless
communications equipment
IEC 61000-4-3 List of frequencies,
from 9 V/m up to 28 V/m,
PM (18 Hz or 217 Hz), FM 1 kHz
Complies
Immunity from Electrical
Fast transient (EFT)
IEC 61000-4-4 ± 2.0 kV on 230 VAC @ 50 Hz;
& 220 VAC mains @ 60 Hz;
Tr/Th – 5/50 ns, 100 kHz
Complies
Immunity from Surge IEC 61000-4-5 ±2.0 CM / ±1.0 kV DM on 230 VAC
mains
@ 50 Hz; & 220 VAC mains @ 60 Hz;
Tr/Th – 1.2/50 (8/20) ms
Complies
Immunity from conducted
disturbances induced by
radio-frequency fields
IEC 61000-4-6 3.0, 6.0 VRMS on 230 VAC mains @ 50
Hz
& 220 VAC mains @ 60 Hz & Wand
cable;
0.15÷ 80 MHz, 80% AM @ 1 kHz
Complies
Immunity from voltage dips,
short interruptions and
voltage variations
IEC 61000-4-11 On 230 VAC & 100 VAC mains @ 50 Hz:
0 % - 0.5 cycle & 1 cycle;
70% - 25 cycles; 0% - 250 cycles;
on 220 VAC mains @ 60 Hz: 0 % - 0.5
cycle & 1 cycle; 70% - 30 cycles; 0% -
300 cycles
Complies
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
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