iTero Element 5D Instructions For Use Manual

Imaging system

instructions

for use

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iTero Element 5D instructions for use English

Copyright

Copyright © by Align Technology, Inc. 2018. 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 document 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 Inc.

This document describes the iTero® Element 5D Optical Impression
Device. English language version. Updated in November 2018.

Trademarks

The following are trademarks and/or service marks of Align Technology,
Inc. or one of its subsidiaries or aliated companies and may be
registered in the U.S. and/or other countries:
Align Technology Inc., iTero®

Any other trademarks or registered trademarks appearing in this
document are the property of their respective owners.

USA oce

Corporate Headquarters
Align Technology, Inc.
2820 Orchard Parkway
San Jose, California 95134

www.aligntech.com

Tel: [phone]
Fax: [phone]

Align Technology Ltd.

3 Ariel Sharon Boulevard
Or-Yehuda 6037606
Israel

Tel: [phone]
Fax: [phone]

Netherlands oce

International Headquarters

Align Technology B.V.
Arlandaweg 161
1043 HS Amsterdam

Tel: [phone]
Fax: [phone]

Customer support

Tel: [phone]

E-mail:
[e-mail]

E-mail:
[e-mail]

Obelis s.a.
Boulevard Général Wahis 53
B - 1030 Brussels, Belgium

www.obelis.net

Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

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iTero Element 5D instructions for use English

Table of contents

Introduction 2

Intended use 2

Chapter 1: System registration 3

Demo Mode 3

Make it Mine 3

Chapter 2: Logging in to the scanner application 6

Login 6

Create account 6

Forgot password 6

Chapter 3: iTero Element 5D main features 7

Home screen 7

Main desktop icons 7

Utility icons 8

Touch screen gestures 9

Wand controls 10

Demo Mode 10

Chapter 4: Messages 12

Chapter 5: Orders 13

Chapter 6: Scan 14

Start a new scan 14

Chapter 7: Element 5D screens 17

Review tool for iTero Element 5D imaging system 17

Using NIRI 18

Chapter 8: Patients 21

Chapter 9: iTero TimeLapse 22

Chapter 10: iTero Element 5D operational manual 24

Chapter 11: iTero Element 5D laptop configuration operational manual 24

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iTero Element 5D instructions for use English

Introduction

The iTero Element 5D intra-oral scanner is Align Technology’s latest
generation integrated scanner and software system. It enables doctors
to take 3D digital scans of patients’ teeth and bite, make adjustments of
the scan in real time and transmit the results wirelessly.

This user guide provides general information and an overview of
the application.

Intended use

The iTero Element 5D is an intra-oral scanner with the following features
and intended/indicated for use:

1. The optical impression (CAD/CAM) feature of iTero Element 5D is
intended/indicated for use to record the topographical images of
teeth and oral tissue. Data generated from iTero may be used in
conjunction with the production of dental devices (e.g., aligners,
braces, appliances, etc.) and accessories.

2. iTero Element 5D software is used with the iTero Element 5D
scanner in capturing 3D digital impressions of teeth, oral soft
tissue and structures, and bite relationship. iTero software controls
the processing of the data, facilitating the integration of data, and
exporting of the data for CAD/CAM fabrication of dental restorations,
orthodontic devices, abutments, and accessories. In addition to scan
data, various patient and case information can be imported/exported
or used for simulation purposes. Other functions are available for
verification and service of the system and to serve as an order
management tool.

3. The iTero Element 5D NIRI functionality, is a diagnostic aid for the
detection of interproximal caries lesions above the gingiva and for
monitoring the progress of such lesions.

This all-in-one system is available on a monitor with a fully interactive,
touch screen display and an easy-to-use scanner. The topography of a
patient’s teeth can be viewed on the screen as they are being scanned,
and determining the degree of occlusion of the bite can be analyzed as

the scan is completed.

In conjunction with the scanner, the application facilitates the following
tasks by:

• Capturing 3D digital impressions of teeth, oral soft tissue and
structures as they are being scanned.

• Enabling real-time viewing of the visual bite relationship once the
scan is completed.

• Managing the processing of the data.

• Sending the data wirelessly to designated providers for the
fabrication of dental restorations, orthodontic devices, abutments,
and accessories, etc.

• Using the data for simulation purposes.

The application also includes administrative capabilities which enable
the user to:

• Start a new scan.

• Place a new order for an existing patient or new patient.

• View orders in progress.

Review and/or track past orders.

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iTero Element 5D instructions for use English

Chapter 1:

System registration

Demo Mode

Press Demo Mode to familiarize yourself with the scanner’s features
and perform practice scans without submitting the scans. Demo Mode
is designed for training new sta members and practice. Demo Mode
is available anytime for dental practices to train on an iTero Element
5D device, for scanning techniques, how-to guidelines for prescription
forms, case types, and to familiarize with the iTero interface. Demo
Mode will feature all the aspects of the scanning process and include a
wide variety of cases. Sample cases oered will include clinical cases,
Invisalign cases, and restorative cases for your convenience.

When Demo Mode is in use for practice scanning, a lightly striped
background and red tag in the upper left-hand corner will indicate Demo
Mode. Any scans captured in Demo Mode cannot be saved or submitted
for patient treatment. Demo Mode is available to access on the Welcome
screen or at any point by pressing the iTero Element logo button on the
home screen.

Make it Mine

Press Make It Mine to register your scanner. Please have your
User Name, User Password, and Company ID ready to complete
the registration process. You will receive an email from an iTero
representative with login credentials and detailed information on the how
to Make it Mine procedure.

Demo Mode

Make it Mine

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2

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iTero Element 5D instructions for use English

1. Select the appropriate Network Connection

2. Network connection verification

3. Register the system

4. System is registered

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iTero Element 5D instructions for use English

5. Accept the License Agreement 7. System is now ready

6. Updating SW to the latest version

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iTero Element 5D instructions for use English

Login

When the scanner is powered on, the login screen for the iTero Element
5D will appear.

Please have your MyiTero account information ready when logging
in to the iTero Scanner. You will need your name, account email, and
password. Fill out all the necessary fields and click the Login button.

Create account

To create an account, please press the bottom button labeled Create
Account. Enter an email and create an account to use on the iTero
Scanner and MyiTero.com.

Forgot password

If you forgot your password, press the lower button labeled Forgot
Password. Enter your registered account email and a temporary
password will be sent to your email. Alternatively, answer your
predetermined security question and gain access to the account from
the scanner.

Chapter 2:

Logging in to the scanner application

User information

Create Account

Forgot Password

Login

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