Nature of emitted scanner radiation
l
Electromagnetic radiation (EMR)
- When used as directed, the iTero scanner’s level of electromagnetic
radiation is similar to that of a personal computer and complies with International Standard IEC 60601-1-2.
l
Laser and LED radiation
- When used as directed, the iTero scanner’s level of Laser and LED radiation is
incapable of producing damage to eyes or other human tissue and complies with International standards IEC
62471 and IEC 60825-1.
Symbols
The following symbols may appear on iTero Element 5D and iTero Element 5D Plus hardware components and
may appear within this document and other iTero Element literature.
Follow instructions for use.
Type BF applied part.
Separate collection of electrical waste and electronic
equipment is required. In compliance with the European
Directive on Waste Electrical and Electronic Equipment
(WEEE), do not dispose of this product in domestic or
municipal waste. This device contains WEEE materials.
Please contact the EARN service.
Link for the online request form:
Caution
- Wherever this symbol appears on the device,
it is mandatory to refer to safety-related information in
this document.
Do not re-use.
CAUTION:
US Federal Law restricts this device to sale
by or on the order of a licensed Dentist, Orthodontist, or
Dental Professional. The system serves as a
prescription medical device and should be operated by
qualified health-care providers only.
Medical device manufacturer.
Catalogue number.
Serial number.
Alternating current.
Keep dry.
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
© 2022 Align Technology, Inc. All rights reserved.
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Summary of Contents for iTero Element 5D
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