B EMC declarations
B.1 EMC declaration – iTero Element 5D
IEC 60601-1-2 Edition 4.0 (2014) 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 (2015)
ETSI EN 301 489-1, ETSI EN 301 489-17
(relevant for wheel-stand configurations only)
Electromagnetic Compatibility (EMC) standard for radio
equipment and services
Environment for intended use Professional Healthcare and Home Healthcare Facility
Environment
The iTero Element 5D imaging system essential performances are:
l
Display near-infrared imaging without interference on the iTero Element 5D 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 scanners:
Test Standard Class / Severity level Test results
Emission (IEC 60601-1-2 section 7)
Conducted emission
Freq. range: 150 kHz - 30
MHz
CISPR 11 Group 1 Class B on 230, 220, 120 & 100
VAC mains @ 50 Hz; 220 VAC mains @
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 @ 50 Hz & 60 Hz
Complies
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
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