iTero Element 2 - Scanner Warnings; Electromagnetic Interference

© 2019 Align Technology, Inc. All rights reserved.
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iTero Element 2 and iTero Element Flex User Manual
Scanner
warnings
 The wand emits red laser light (680nm Class 1), as well as white LED emissions.
Normal usage of the wand does not present any danger to the human eye.
However, you should refrain from shining the wand directly into the patient’s
eyes.
 Avoid twisting, knotting, pulling, and stepping on the cable.
 When the system is not in use, the wand should be placed in the cradle with the
probe facing the touch screen, so there will be no eye contact with the laser
beam, or the flickering white LED emission.
 Activate the wand only while the tip of the wand is in the patient’s mouth.
 Avoid placing the wand in the cradle while the scanning operation is still active.
 If a scanner malfunction occurs or if physical damage is observed, stop scanning
and call Customer Support.
Cleaning &
disinfection
 To avoid cross-contamination, it is mandatory to:
o Clean and disinfect the wand, as described in section 10.2, and replace the
disposable wand sleeve as described in section 1.4.3.1.1, after each patient
session.
o Remove and replace gloves after each patient session.
o Discard torn, contaminated, or removed gloves.
 Dispose of scanner sleeves according to standard operating procedures or local
regulations for the disposal of contaminated medical waste.
Unpacking &
installing
The system should be unpacked and installed following Align Technology’s
instructions, described in section 2.1.
Work
environment
 The system should be moved between rooms with utmost care to avoid damage.
 Do not block the air vents on the wand and the screen.
 The system is intended for indoor use only. It should not be exposed to direct
sunlight, excessive heat, or humidity.
 iTero Element Flex only: If the iTero Element Flex 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
WARNING: 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. However, because of the proliferation of
radio-frequency transmitting equipment and other sources of electrical and
electromagnetic interference in the healthcare environments (e.g., cellular phones,
mobile two-way radios, electrical appliances, RFID), it is possible that high levels of
such interference due to close proximity or strength of 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
WARNINGS:
 No modification of this equipment is allowed.
 iTero Element 2 only: The touch screen must always be attached to the stand
after assembly.