iTero Element 2 - Contraindications and Compliance; Class 1 Laser Compliance; EMC Compliance; CSA Compliance

iTero Element 2 and iTero Element Flex User Manual
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iTero Element 2 and iTero Element Flex User Manual
Contraindications
For persons who have been diagnosed with Epilepsy, there is a risk of epileptic shock from the flashing light
of the iTero scanner. These persons should refrain from any eye contact with the flashing light associated with
the system during operation.
Compliance
Class 1 laser compliance
This device complies with “21 CFR 1040. 10” and
“EN 60825-1”
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”.
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”.
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”.
FCC compliance
This device complies with Part 15 of FCC Rules and
its operation is subject to the following two
conditions:
This device may not cause harmful
interference.
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.
CE compliance
This device complies with Council Directive
93/42/EEC for Medical Devices.