Align Technology iTero Element 5D - Page 228

Test Standard Class / Severity level Test results
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
Immunity from voltage dips,
short interruptions and
voltage variations
IEC 61000-4-11 /
EN 61000-4-11
On AC mode (240 V @ 50 Hz, 100 V @
50 Hz): 0 % - 0.5 cycle & 1 cycle;
70% - 25 cycles; 0% - 250 cycles;
On AC mode (220 V @ 60 Hz):
0 % - 0.5 cycle & 1 cycle;
70% - 30 cycles; 0% - 300 cycles
Complies
Emission (per ETSI EN 301 489-1, ETSI EN 301 489-17)
Conducted emissions on
mains terminals in freq.
range 150 kHz - 30 MHz
ETSI EN 301 489-1;
ETSI EN 301 489-17 /
EN 55032
Group 1 Class B
230 VAC mains
Complies
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
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