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iTero Element 5D operation manual English
Test Standard Class / Severity level Test result
Documentation (IEC 60601-1-2 sections 4 and 5)
General requirements for EMC section 4.1 -- Complies
External labels section 5.1 -- Complies
Conformity of users’ manual section 5.2.1 -- Complies
Accuracy of technical description section 5.2.2 -- Complies
Emission (IEC 60601-1-2 / EN 60601-1-2 section 7)
Conducted emission
Freq. range:150 kHz - 30 MHz
CISPR 11
Group 1 Class B 230, 120 & 100 VAC mains (50 Hz);
220 VAC mains (50 & 60 Hz)
Complies
Radiated emission
Freq. range: 30 - 1000 MHz
CISPR 11 Group 1 Class B Complies
Harmonic current emission test IEC 61000-3-2 230 VAC mains (50 Hz & 220 V (60 Hz) Complies
Voltage changes, voltage fluctuations and flicker test IEC 61000-3-3 230 VAC mains & 220 VAC mains 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 AC mains; Tr/Th – 5/50 ns, 100 kHz Complies
Immunity from surge IEC 61000-4-5
±2.0 CM / ±1.0 kV DM on AC mains;
Tr/Th – 1.2/50 (8/20) μs
Complies
Immunity from conducted disturbances induced by radio-
frequency fields
IEC 61000-4-6
3.0, 6.0 VRMS on 230 VAC mains & wand cable;
0.15÷ 80 MHz, 80% AM 1 kHz
Complies
Immunity from voltage dips, short interruptions and voltage
variations
IEC 61000-4-11
0 % - 0.5 cycle & 1 cycle; 70% - 25 cycles;
0% - 250 cycles on AC mains
Complies
Appendix A:
EMC declaration
Summary of EMC test results for iTero Element 5D
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