iTero Element Operation Manual page 4

ENGLISH
CLASS 1 LASER COMPLIANCE
Class 1 Laser Product
CSA COMPLIANCE
C US
FCC COMPLIANCE
FCC Warning
Modifications to the device that are not expressly approved by the manufacturer may void your
authority to operate the device under FCC Rules.
EMC COMPLIANCE
This device complies with the following EMC standard:
"IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic phenomena - Requirements and tests".
SAFETY COMPLIANCE
This device complies with the following safety standard:
"IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential
performance.
CE COMPLIANCE
This device complies with Council Directive 93/42/EEC for Medical Devices.
ii
2017 Align Technology, Inc.
This device complies with: "21 CFR 1040.10" and "EN 60825-1".
This device complies with the following CSA standard for Canada and the USA:
"UL Std No. 60601-1 Second Edition – Medical Electrical Equipment Part 1:
General Requirements for Safety"
This device complies with Part 15 of FCC Rules and its operation is subject to the
following two conditions:
1) This device may not cause harmful interference.
2) This device must accept any interference received, Including interference that
may cause undesired operation.
Publication 109797
iTero ® Element Operation Manual
™