iTero Element 2 - EMC Declaration

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101
iTero Element 2 and iTero Element Flex User Manual
12 EMC declaration
IEC 60601-1-2 Edition 4.0 (2014)
Medical electrical equipment; Part 1-2: Collateral Standard:
Electromagnetic compatibility - Requirements and tests
CFR 47 FCC
Rules and Regulations:
Part 15. Radio frequency devices.
Subpart B: Unintentional radiators (2015)
ETSI EN 301489-1
(Relevant for iTero Element 2 only)
Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 1: Common technical
requirements
Environment for intended use
Professional Healthcare and Home Healthcare Facility
Environment
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 2 and iTero Element Flex scanners:
Test
Standard
Severity level/lines
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
Voltage changes, Voltage
fluctuations and Flicker test
IEC 61000-3-3
230 VAC mains @ 50 Hz
& 220 VAC mains @ 50 Hz
Complies