B.2 EMC declaration – iTero Element 5D Plus
IEC 60601-1-2 Edition 4.0 (2014 )/EN
60601-1-2 (2015)
Medical electrical equipment; Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests.
CFR 47 FCC Rules and Regulations:
Part 15. Radio frequency devices.
Subpart B: Unintentional radiators (2020)
ETSI EN 301 489-1, ETSI EN 301 489-17 Electromagnetic Compatibility (EMC) standard for radio
equipment and services
Environment for intended use Professional Healthcare and Home Healthcare Facility
Environment
The iTero Element 5D Plus imaging system essential performances are:
l
Display near-infrared imaging without interference on the iTero Element 5D Plus touch screen as part of the
caries-detection solution.
l
Stored scan data is accessible and can be displayed.
Note: Due to electromagnetic disturbance, in some cases, the image may disappear and a non-communication
message will appear on the touch screen. The scanner will return to operation mode after user intervention or
auto-recovery.
The following is a summary of the EMC test results for iTero Element 5D Plus scanners:
Test Standard Class / Severity level Test results
Emission (IEC 60601-1-2 / EN 60601-1-2 section 7.1 & 7.2)
Conducted emission
Freq. range: 150 kHz - 30
MHz
CISPR 11 / EN 55022 Group 1 Class B: – AC mains (240 V,
230 V, 120 V, 100 V;
220 V @ 60 Hz)
Complies
Radiated emission
Freq. range: 30 - 1000 MHz
CISPR 11 /
EN 55022
Group 1 Class B Complies
Harmonic current emission
test
IEC 61000-3-2 /
EN 610003-2
AC mains
(230 V @ 50 Hz & 220 V @ 60 Hz)
Complies
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)
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
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