iTero Element 5D Plus User manual

iTero
Element® 5D Plus
User manual
it starts with

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.
Copyright
© 2020 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: 210886 Rev. B
Updated November 2020
USA office
Corporate Headquarters
Align Technology, Inc.
2820 Orchard Parkway
San Jose, California 95134
www.aligntech.com
Tel: [phone]
Fax: [phone]
Customer Support
Tel: [phone]
E-mail: [e-mail]
Align Technology Ltd.
3 Ariel Sharon Boulevard
Or-Yehuda 6037606
Israel
Tel: [phone]
Fax: [phone]
iTero Element® 5D Plus User manual
© 2020 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.
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 Plus User manual
ii © 2020 Align Technology, Inc. All rights reserved.

Symbols
The following symbols may appear on iTero Element 5D Plus hardware components and may appear within this
document and other iTero Element 5D Plus literature.
Wherever this symbol appears on the device, it is
recommended to refer to this document for information on
the proper usage of the device.
Applied part type BF. Any component on which this
symbol appears is electric isolation type BF.
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
Attention! This symbol is used to highlight the fact that
there are specific warnings or precautions associated
with the device. Wherever this symbol appears on the
device, it is mandatory to refer to safety-related
information in this document.
Parts or accessories on which this symbol occurs should
not be reused.
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.
Order number.
Serial number.
Alternating current.
Indicates a medical device that needs to be protected
from moisture.
Indicates the temperature limits to which the medical
device can be safely exposed.
iTero Element® 5D Plus User manual
© 2020 Align Technology, Inc. All rights reserved. iii

Manufacturer’s batch code.
Indicates the range of atmospheric pressure to which the
medical device can be safely exposed.
Indicates the range of humidity to which the medical
device can be safely exposed.
Fragile, handle with care.
This side should be up.
IEC 60417-5031: Direct current.
Wand (scanning unit).
This device complies with Council Regulations (EU)
2017/754 for Medical Devices.
Indicates the need for the user to consult the instructions
for use.
USB socket.
Electric battery.
IEC 60417-5009: STAND-BY.
Use-by date. This symbol is accompanied by a date to
indicate that the iTero Element 5D wand barrier sleeves
should not be used after the end of the year, month, or
day shown.
iTero Element® 5D Plus User manual
iv © 2020 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 an internal medical-grade power supply.
Battery power lCharging – the scanner battery will be fully charged after being plugged into a power source for
2.5 hours.
lWith a fully-charged battery, you can scan up to 30 minutes.
lThe scanner is provided with two Li-ion rechargeable battery packs. 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. Use only the original AC/DC adaptor 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.
Electric
warnings
lDo not remove external panels, covers, and batteries in order to avoid electrical shock. There
are no user-serviceable parts inside. 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.
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 a power cable that is not approved by Align Technology to the system, in order
to avoid electrical shock.
Wireless LAN The system comes equipped with a wireless LAN unit.
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.
iTero Element® 5D Plus User manual
© 2020 Align Technology, Inc. All rights reserved. v

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 probe 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 section 1.1, and replace the wand barrier
sleeve, as described in section 4.1, before each patient session.
oRemove and replace gloves after each patient session.
oDiscard torn, contaminated, or removed gloves.
oDispose of wand barrier 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
lThe system should be moved between rooms with utmost care to avoid damage.
lDo not block the air vents on the wand and the screen.
lThe system is intended for indoor use only. It should not be exposed to direct sunlight,
excessive heat, or humidity.
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.
lDo not remove the touch screen from the stand after assembly.
iTero Element® 5D Plus User manual
vi © 2020 Align Technology, Inc. All rights reserved.

Table of contents
1 Introduction 1
1.1 Intended use 1
1.2 Benefits 1
1.3 iTero Element 5D Plus hardware 2
1.3.1 iTero Element 5D Plus wand 3
1.4 iTero Element 5D Plus software 4
1.5 Working with near infra-red imaging (NIRI) 5
1.5.1 Limitations 7
1.6 About this manual 7
2 Getting started 9
2.1 Assembling the iTero Element 5D Plus scanner 9
2.2 Logging in to the scanner for the first time 14
2.3 Registering the scanner – Make It Mine process 14
2.4 Working in Demo Mode 20
2.4.1 Exiting Demo Mode 25
3 Working with the iTero Element 5D Plus scanner 27
3.1 Logging in to the scanner 27
3.1.1 Resetting your password 30
3.1.2 Installing Windows security updates 32
3.2 Logging out of the scanner 33
3.3 Shutting down the scanner 33
3.4 Moving the scanner 34
3.5 User interface 35
3.5.1 Scanner toolbar 38
3.5.2 Touch-screen gestures 41
3.6 Defining the scanner settings 41
3.6.1 Defining the Computer settings 43
3.6.2 Defining the User settings 47
3.6.3 Defining the System settings 55
4 Starting a new scan 61
4.1 Applying a wand barrier sleeve 61
4.2 Starting the scan 63
iTero Element® 5D Plus User manual
© 2020 Align Technology, Inc. All rights reserved. vii

4.3 Patient management 65
4.3.1 Adding new patients 66
4.3.2 Searching for existing patients 69
4.3.3 Editing the patient details 73
4.3.4 Clearing the patient details from the New Scan window 75
4.4 Filling in the Rx 76
4.4.1 Working with restorative scan types 79
4.4.2 Disabling NIRI capture 84
4.4.3 Confirming a new wand barrier sleeve between patients 86
4.5 Scanning the patient 87
4.5.1 Scanning guidance 88
4.5.2 Scanning best practices 89
4.5.3 Scan options 90
4.5.4 Toggling the 3D and viewfinder display 92
4.5.5 Toggling between color and NIRI images in the viewfinder 94
4.5.6 Editing a scan 94
4.6 Viewing the scan 95
4.6.1 Missing scan segment notifications 96
4.6.2 Using the scan timer 97
4.7 Sending the scan 97
4.8 Working with the Viewer 98
4.9 Removing the wand barrier sleeve 102
5 Working with patients 105
5.1 Searching for patients 106
5.2 Viewing the patient details 107
5.3 Creating a new scan for a specific patient 107
5.4 Viewing the Rx 109
5.5 Viewing previous scans in the Viewer 110
6 Working with orders 113
7 Viewing messages 117
8 Working with MyiTero 119
9 iTero scanner features and tools 121
9.1 Comparing previous scans using iTero TimeLapse technology 121
9.2 Invisalign Go system 124
9.3 Invisalign Outcome Simulator 125
iTero Element® 5D Plus User manual
viii © 2020 Align Technology, Inc. All rights reserved.