Work
environment
l
The system should be moved between rooms with utmost care to avoid damage.
l
Do not block the air vents on the wand and the computing unit.
l
The system is intended for indoor use only. It should not be exposed to direct sunlight,
excessive heat, or humidity.
l
iTero Element 5D laptop configuration only: If the system has just been brought into the
office from a hot, cold, or humid environment, it should be set aside until it has adjusted to
the room temperature, to avoid internal condensation.
Electromagnetic
interference
precaution
This device has been tested and found to comply with the requirements for medical devices
according to standard IEC60601-1-2. This standard is designed to provide reasonable
protection against harmful interference in a typical medical installation.
Avoid placing this device near frequency transmitting equipment or other sources of electrical
and electromagnetic interference (e.g. cellular phones, mobile two-way radios, electrical
appliances, RFID). High levels of such interference, due to close proximity or strength of the
source, may result in disruption of performance of this device. In this case, the device can be
returned to operation mode after user intervention or by auto-recovery.
General
Notes:
l
Do not make any modifications to this equipment.
l
l
Cart and wheel-stand configurations only: Do not remove the computing unit from the stand
after assembly.
Incident
notification
Any serious incidents in relation to the iTero device should be reported to Align Technology
Ltd. and the competent authority of the Member State in which the user and patient are
established.
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
© 2022 Align Technology, Inc. All rights reserved.
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