B EMC declaration
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 intraoral scanner 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 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
iTero Element® 5D Plus User manual
© 2020 Align Technology, Inc. All rights reserved. 171
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