iTero Element 5D - Regulatory Compliance; Laser, CSA, and FCC Compliance; EMC, Safety, and CE Compliance

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iTero Element 5D operation manual English
Class 1 laser compliance
This device complies with: “21 CFR 1040.10” and “EN 60825-1”.
CSA compliance
This device complies with the following CSA standard for Canada
and the USA:
“UL Std No. 60601-1 – Medical Electrical Equipment Part 1: General
Requirements for Safety”
FCC compliance
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.
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.
Class 1 Laser Product
C US