Appendix A: Emc Declaration - iTero Element 5D Configuration Operation Manual

iTero Element 5D laptop configuration operation manual
Appendix A:
EMC declaration
Summary of EMC test results for iTero Element 5D laptop configuration
Test
Documentation (IEC 60601-1-2 sections 4 and 5)
General requirements for EMC
External labels
Conformity of users' manual
Accuracy of technical description
Emission (IEC 60601-1-2 section 7)
Conducted emission Freq. range:150 kHz - 30 MHz
Radiated emission Freq. range: 30 - 1000 MHz
Harmonic current emission test
Voltage changes, voltage fluctuations and flicker test
Immunity (IEC 60601-1-2 section 8)
Immunity from electrostatic discharge (ESD)
Immunity from radiated electromagnetic fields
Immunity from proximity field from wireless
communications equipment
Immunity from electrical fast transient (EFT)
Immunity from surge
Immunity from conducted disturbances induced by radio-
frequency fields
Immunity from voltage dips, short interruptions and
voltage variations
English
Standard Class / Severity level
section 4.1 --
section 5.1 --
section 5.2.1 --
section 5.2.2 --
Group 1 Class B
CISPR 11 230, 120 & 100 VAC mains @ 50 Hz;
220 VAC mains @ 60 Hz
CISPR 11 Group 1 Class B
230 VAC mains @ 50 Hz
IEC 61000-3-2
& 220 V @ 60 Hz
230 VAC mains @ 50 Hz
IEC 61000-3-3
& 220 V @ 60 Hz
IEC 61000-4-2 8 kV contact discharges & 15 kV air discharges
IEC 61000-4-3 10.0 V/m; 80 MHz ¸ 2.7 GHz, 80% AM, 1 kHz
List of frequencies, from 9 V/m up to 28 V/m,
IEC 61000-4-3
PM (18 Hz or 217 Hz), FM 1 kHz
IEC 61000-4-4 ± 2.0 kV - on AC mains; Tr/Th – 5/50 ns, 100 kHz
±2.0 CM / ±1.0 kV DM
on 230 VAC mains @ 50 Hz
IEC 61000-4-5
& 220 VAC mains @ 60 Hz;
Tr/Th – 1.2/50 (8/20) ms
3.0, 6.0 VRMS
IEC 61000-4-6 on 230 VAC mains & wand cable;
0.15÷ 80 MHz, 80% AM @ 1 kHz
On 230 VAC & 100 VAC mains @ 50 Hz:
0 % - 0.5 cycle & 1 cycle;
70% - 25 cycles; 0% - 250 cycles
IEC 61000-4-11
on 220 VAC mains @ 60 Hz:
0 % - 0.5 cycle & 1 cycle;
70% - 30 cycles; 0% - 300 cycles
Test result
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