iTero Element 5D Plus - Page 190

Test Standard Class / Severity level
Test
results
Voltage changes, Voltage
fluctuations and Flicker test
IEC 61000-3-3
/
EN 610003-3
AC mains
(230 V @ 50 Hz & 220 V @ 50
Hz)
Complies
Immunity (IEC 60601-1-2 / EN 60601-1-2 sections 8.9 and 8.10)
Immunity from Electrostatic
discharge (ESD)
IEC 61000-4-2
/
EN 61000-4-2
8 kV contact discharges & 15 kV
air discharges (AC mode (230 V
@ 50 Hz & 220 V @ 60 Hz) &
Battery mode)
Complies
Immunity from radiated
electromagnetic fields
IEC 61000-4-3
/
EN 61000-4-3
10.0 V/m; 80 MHz ÷ 2.7 GHz,
80% AM, 1 kHz
(AC mode ((230 V @ 50 Hz &
220 V @ 60 Hz) & Battery mode)
Complies
Immunity from Proximity field from
wireless communications
equipment
IEC 61000-4-3
/
EN 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
/
EN 61000-4-4
± 2.0 kV on AC mains
(230 V @ 50 Hz & 220 V @ 60
Hz);
Tr/Th – 5/50 ns, 100 kHz
Complies
Immunity from Surge IEC 61000-4-5
/
EN 61000-4-5
±2.0 CM / ±1.0 kV DM on AC
mains
(230 V @ 50 Hz & 220 V @ 60
Hz);
Tr/Th – 1.2/50 (8/20) µs
Complies
Immunity from conducted
disturbances induced by radio-
frequency fields
IEC 61000-4-6
/
EN 61000-4-6
6.0 VRMS on AC mains
(230 V @ 50 Hz & 220 V @ 60
Hz)
& Patient cable;
0.15÷ 80 MHz, 80% AM, 1 kHz
Complies
Immunity from power frequency
magnetic field
IEC 61000-4-8
/
EN 61000-4-8
30 A/m @ 50 Hz & 60 Hz
(AC mode and Battery mode)
Complies
iTero Element® 5D Plus User manual
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