iTero Element 5D Configuration Operation Manual
Also see for Element 5D: Instructions for useConfiguration operation manual
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Contents
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22iTeroElement 5D o p e r a t ion m a n u a l E n g l ishTest Standard Class / Severity level Test resultDocumentation (IEC 60601-1-2 sections 4 and 5)General requirements for EMC section 4.1 -- CompliesExternal labels section 5.1 -- CompliesConformity of users’ manual section 5.2.1 -- CompliesAccuracy of technical description section 5.2.2 -- CompliesEmission (IEC 60601-1-2 / EN 60601-1-2 section 7)Conducted emissionFreq. range:150 kHz - 30 MHz CISPR 11 Group 1 Class B 230, 120 & 100 VAC mains (50 Hz);220 VAC mains (50 & 60 Hz) CompliesRadiated emissionFreq. range: 30 - 1000 MHz CISPR 11 Group 1 Class B CompliesHarmonic current emission test IEC 61000-3-2 230 VAC mains (50 Hz & 220 V (60 Hz) CompliesVoltage changes, voltage fluctuations and flicker test IEC 61000-3-3 230 VAC mains & 220 VAC mains CompliesImmunity (IEC 60601-1-2 section 8)Immunity from electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact discharges & 15 kV air discharges CompliesImmunity from radiated electromagnetic fields IEC 61000-4-3 10.0 V/m; 80 MHz ÷ 2.7 GHz, 80% AM, 1 kHz CompliesImmunity from proximity field from wireless communicationsequipment 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 CompliesImmunity from electrical fast transient (EFT) IEC 61000-4-4 ± 2.0 kV - on AC mains; Tr/Th – 5/50 ns, 100 kHz CompliesImmunity from surge IEC 61000-4-5 ±2.0 CM / ±1.0 kV DM on AC mains;Tr/Th – 1.2/50 (8/20) μs CompliesImmunity 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 CompliesImmunity from voltage dips, short interruptions and voltagevariations IEC 61000-4-11 0 % - 0.5 cycle & 1 cycle; 70% - 25 cycles;0% - 250 cycles on AC mains CompliesAppendix A:EMC declarationSummary of EMC test results for iTero Element 5D |
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