Align Technology iTero Element 5D User manual

it starts with
iTero Element 5D
and
iTero Element 5D Plus
imaging systems
User manual

Copyright
© 2022 Align Technology, Inc. All rights reserved.
The information contained in this manual is subject to
change without notice.
The hardware and software described in this manual
are supplied under a Sales and Services Agreement
and may be used only in accordance with the terms of
that agreement.
No part of this manual may be reproduced,
photocopied, stored in a retrieval system, or
transmitted in any manner (electronic or mechanical)
for any purpose other than the customer’s normal
usage, without the prior written permission of Align
Technology.
English language version
P/N: 215411 Rev. A
Updated May 2022
Patents
www.aligntech.com/patents
Trademarks
Align, Invisalign, ClinCheck and iTero among others, are
trademarks and/or service marks of Align Technology,
Inc. or one of its subsidiaries or affiliated companies and
may be registered in the U.S. and/or other countries.
Any other trademarks or registered trademarks
appearing in this manual are the property of their
respective owners.
Global headquarters
Align Technology, Inc.
410 North Scottsdale Road,
Suite 1300, Tempe,
Arizona 85281,
USA
www.aligntech.com
Tel: [phone]
Fax: [phone]
Customer Support
Tel: [phone]
E-mail: [email protected]
Align Technology Ltd.
1 Yitzhak Rabin Rd.,
Petach Tikva, 4925110,
Israel
Tel: [phone]
Fax: [phone]
Align Technology B.V.
Herikerbergweg 312
1101 CT, Amsterdam
The Netherlands
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
© 2022 Align Technology, Inc. All rights reserved. i

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 IEC
60825-1.
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.
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.
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.
ANATEL compliance
This device complies with ANATEL resolution nº
242/2000 under the number ANATEL 02563-15-06534.
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.
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
ii © 2022 Align Technology, Inc. All rights reserved.

Nature of emitted scanner radiation
lElectromagnetic 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.
lLaser 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: http://b2btool.earn-
service.com/aligntech/select
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. iii

Batch code.
Atmospheric pressure limitation.
Humidity limitation.
Fragile, handle with care.
This side should be up.
IEC 60417-5031: Direct current.
Wand (scanning unit).
Unique device identifier.
Country of manufacture (including date of
manufacture).
Temperature limit.
Medical device.
Consult the electronic instructions for use.
USB socket.
Electric battery.
IEC 60417-5009: STAND-BY.
Stepping prohibited.
Authorized representative in the European Community.
RoHS compliant for China.
CE mark.
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
iv © 2022 Align Technology, Inc. All rights reserved.

Safety instructions
Before beginning to work with the system, all users are required to read these safety instructions.
Power supply Power is supplied to the system via a medical-grade power supply. In iTero Element 5D Plus
cart configurations, the power supply is enclosed in the base of the wheel stand. In iTero
Element 5D Plus mobile configurations, the power supply is external.
Battery power lCharging – the scanner battery will be fully charged after being plugged into a power
source for 2 hours (iTero Element 5D) or 2.5 hours (iTero Element 5D Plus).
ll With a fully-charged battery, you can scan up to 30 minutes using the wheel-stand or cart-
configuration scanner, or 10 minutes using the mobile-configuration scanner.
Warning: The wheel-stand configuration and cart-configuration scanners are provided with
two Li-ion rechargeable battery packs and the mobile-configuration scanners are provided
with one battery pack. There is a danger of battery explosion if the screen is damaged. Do
not use the scanner if dropped or any damage is noticed. Contact Customer Support.
lUse only the original AC/DC adaptor connected to the system to charge the batteries.
lThe screen should be stored and operated following the environmental conditions that
appear in this manual. Do not expose the scanner to extreme heat sources, such as
radiators and fireplaces.
lNever operate the device without batteries! Do not use the batteries for any purpose other
than the intended use of the product. Discard used batteries according to the
manufacturer's instructions and local requirements.
lReplace the batteries only with the same battery type supplied by Align.
Electric
warnings
lDo not remove external panels, covers, and batteries in order to avoid electrical shock.
There are no user-serviceable parts inside. In iTero Element 5D Plus scanners, you can
open the cover of the diagnostics panel in case of system failure, only when required by
Customer Support.
lDo not connect the scanner to a mains supply without protective grounding, in order to
avoid the risk of electrical shock.
iTero Element 5D Laptop configuration only:
lThe iTero Element 5D laptop configuration is provided with a hub containing the power
supply for the wand. Do not place the system on a wet surface or step on it, in order to avoid
risk of system damage and electrical shock.
lNever connect the hub to a laptop that is not approved according to IEC60950 and to
UL60950-1. The laptop and all its accessories should be located at least 1.5m away from
the patient. Do not scan a patient and touch the laptop or any of its accessories at the same
time. Not following these instructions may lead to electrical shock.
Electric
precautions
lDo not connect a non-Align-approved web camera to the USB sockets on the rear of the
touch screen, in order to avoid the risk of electrical shock.
lDo not connect anything besides the iTero wand to the USB sockets on the hub.
lDo not connect a power cable that is not approved by Align Technology to the system, in
order to avoid electrical shock.
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
© 2022 Align Technology, Inc. All rights reserved. v

Wireless LAN lThe system comes equipped with a wireless LAN unit.
lWhen using the product, maintain a separation distance of at least 20cm between the
computing unit and all persons' bodies to ensure compliance with RF exposure
requirements.
Safety
classifications
lType of protection against electrical shock: Class 1.
lDegree of protection against electrical shock: Type BF.
lDegree of protection against harmful ingress of water: Ordinary.
lEquipment not suitable for use in the presence of flammable anesthetic mixtures.
lMode of operation: Continuous.
Prescription
health device
The system serves as a prescription medical device and should be operated by qualified
health-care providers only.
Scanner
precautions
lThe wand emits red laser light (680nm Class 1) as well as white LED emissions and 850nm
LED emissions. Normal usage of the wand does not present any danger to the human eye.
Avoid shining the wand directly into the patient’s eyes.
lAvoid twisting, knotting, pulling, and stepping on the wand cable and the power cable.
lWhen the system is not in use, the wand should be placed in the cradle with the optical
surface facing the touch screen, in order to avoid eye contact with the laser beam, flickering
white LED emission, and 850nm LED emission. Eye contact could cause damage to the
eyes.
lAvoid activating the wand while the tip of the wand is outside the patient’s mouth, in order to
prevent eye damage.
lAvoid placing the wand in the cradle while the scanning operation is still active, in order to
prevent eye damage.
lDo not use the equipment if a scanner malfunction occurs or if physical damage is
observed, in order to avoid electrical shock or physical injury. Call Customer Support.
Cleaning &
disinfection
lTo avoid cross-contamination, it is mandatory to:
oClean and disinfect the wand, as described in Cleaning and disinfecting the wand, and
replace the wand sleeve, as described in Applying a wand sleeve, before each patient
session.
oRemove and replace gloves after each patient session.
oDiscard torn, contaminated, or removed gloves.
oReplace the wand sleeve between each patient. Failing to replace the wand sleeve
between patients may cause the inadvertent transfer of microorganisms and other
contaminants from one patient to another.
oDispose of wand 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 Assembly instructions.
Note: Contact Customer Support if the scanner box is damaged or if the ShockDot indicator
on the box has been activated.
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
vi © 2022 Align Technology, Inc. All rights reserved.

Work
environment
lThe system should be moved between rooms with utmost care to avoid damage.
lDo not block the air vents on the wand and the computing unit.
lThe system is intended for indoor use only. It should not be exposed to direct sunlight,
excessive heat, or humidity.
liTero 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:
lDo not make any modifications to this equipment.
ll 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. vii

Contre-indications – French
Pour les personnes ayant un diagnostic d’épilepsie, la lumière clignotante du scanner iTero peut engendrer un
risque de choc épileptique. Ces personnes doivent éviter tout contact visuel avec la lumière clignotante inhérente
au système pendant le fonctionnement.
Conformité – French
Conformité du laser de classe 1
Cet appareil est conforme aux normes 21 CFR 1040.10
et IEC 60825-1.
Conformité aux normes de sécurité
Cet appareil est conforme à la norme de sécurité
suivante :
IEC 60601-1 Appareils électromédicaux - Section 1 :
Exigences générales pour la sécurité de base et les
performances essentielles.
Conformité CSA
Cet appareil est conforme à la norme CSA suivante
pour le Canada et les États-Unis : UL Std No. 60601-1 -
Appareils électromédicaux - Section 1 : Règles
générales de sécurité.
Conformité CEM
Cet appareil est conforme à la norme CEM suivante :
IEC 60601-1-2 Appareils électromédicaux - Section 1-2
: Exigences générales pour la sécurité de base et les
performances essentielles - Norme collatérale :
phénomènes électromagnétiques - Exigences et
essais.
Conformité ANATEL
Cet appareil est conforme à la résolution ANATEL n°
242/2000 sous le numéro ANATEL 02563-15-06534.
Conformité FCC
Cet équipement est conforme à la section 15 des règles
la FCC. Son fonctionnement est soumis aux deux
conditions suivantes :
1. Cet appareil ne doit causer aucune interférence
nuisible.
2. Cet appareil doit accepter toute interférence reçue,
y compris des interférences pouvant provoquer un
fonctionnement non désiré.
Avertissement de la FCC
Les modifications apportées à l'appareil qui ne sont pas
expressément approuvées par le fabricant peuvent
révoquer votre droit d'utiliser l'appareil en vertu des
règles de la FCC.
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
viii © 2022 Align Technology, Inc. All rights reserved.