iTero Element 5D User 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:
[email protected]
Obelis s.a.
Boulevard Général Wahis 53
B - 1030 Brussels, Belgium
www.obelis.net
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
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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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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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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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1. Select the appropriate Network Connection
2. Network connection verification
3. Register the system
4. System is registered
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5. Accept the License Agreement 7. System is now ready
6. Updating SW to the latest version
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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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Home screen
The iTero Element 5D home screen provides access to all the main
features of the iTero software.
Below is an image of the iTero Element 5D application’s home screen.
Main desktop icons
There are four main home screen icons for the iTero Element
5D software.
New Scan: To begin a new scan for a patient, select the New Scan
icon. This home screen icon navigates to the iTero Rx form to fill out the
prescription form for a patient and begin scanning.
Patients: To look up any patient on your system, select the Patients
icon. This home screen icon navigates to the Patients page. Search for a
specific patient, scroll through recently scanned patients, review scans,
access iTero TimeLapse, view patient history, add new scans, or add a
treatment plan.
Orders: To view the status of your orders, select the Orders icon. This
home screen icon navigates to a list of orders in progress or past orders.
Messages: To read messages, select the Messages icon. This home
screen icon navigates to the message inbox, where you may read on the
latest notifications from the Align team regarding new updates, improved
features, enhanced tools, and latest developments.
Chapter 3:
iTero Element 5D main features
Main home screen icons
Utility icons
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Utility icons
Battery: To view the charge on the iTero external battery, press the
Battery icon. A battery indicator will appear and specify how long the
battery has until the iTero Element 5D may need to be charged again.
When the battery icon displays a lightning bolt symbol, the battery is
charging. Note: this feature only appears in supported iTero Element
5D scanners.
Learning Center: To access training materials and educational videos for
your iTero Element 5D, press the Learning Center icon.
Lock: To log out of an account whenever the iTero Element 5D is not in
use, press the Lock icon. This will help ensure that the dental practice is
HIPAA compliant and that all medical information is secure.
Settings: To adjust preferences for your iTero Element 5D like
wand configuration, localization, user settings, and more, press the
Settings icon.
Help: To navigate icons for home screen and helpful hints, press the
Help icon. A transparent Help overlay appears over the screen to aid
in navigation of features and tools. At any time, tap the Help icon for
assistance. Tap anywhere to close the Help screen and return to the
relevant screen. Customer support is available on every Help overlay.
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x1
Touch screen gestures
iTero Element 5D application supports touch screen (also known as
multi-touch) gestures. These gestures are predefined motions used to
interact with multi-touch devices.
Examples of common touch screen gestures:
Tap
Scroll
2 finger tap
Pan
Double tap
Rotate
Zoom in/pinch
Long press
Swipe
Zoom out
x2
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Wand controls
Side buttons: Press and release either of the side buttons on the wand to
start or stop the scanning process. Press the buttons simultaneously to
activate the touchpad.
Touchpad: Once activated, swipe left or right on the touchpad to
navigate between scan segments. Press and hold the touchpad will
enable the gyro function to rotate the model on the screen.
Demo Mode
To access demo mode, press the iTero Element logo on the upper left
side of the home screen. A menu will appear to press Demo Mode or to
cancel and return to the home screen. Demo Mode will appear with all
the same functionality as when taking a normal scan. No data will be
permanently saved.
Side buttons
Touchpad
1
12
2
Demo Mode
Exit to Windows
Cancel
1
2
3
1
2
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Demo Mode: Initiate Demo Mode for practice without saving any data.
Exit to Windows: To Exit the iTero interface and return to Windows. Note:
Only available on iTero laptop configuration devices.
Cancel: To exit from the screen and return to normal use.
Demo Mode tag: The red tag indicator when using Demo Mode.
Striped background: A striped background will appear while scanning. It
is designed to prevent scanning real patients in Demo Mode.
Practice any portion of the patient experience. Any scans taken during
Demo Mode cannot be submitted for treatment. To exit Demo Mode,
please go back to the home screen and press the iTero Element logo.
The menu for Demo Mode will appear in order to exit Demo Mode.
1Demo Mode tag
Striped background
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Press the Messages icon from the home screen to view notifications,
updates and other messages from Align Technology. On the left side of
the page, search for specific messages by subject title quickly or, press
on the right side of the screen and scroll down the page to search and
find a specific message. To mark any message as unread, press Mark
as Unread.
Chapter 4:
Messages
Inbox
Mark as Unread
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Tap on the Orders icon to view or review In Progress or Past Orders.
In Progress: Scans that have not been submitted.
Past Orders: Orders that have been submitted. Press on any order to
check the status of the scan.
Clicking on a past order shows the following options, depending on the
case type.
View Rx: View the prescription for this order.
Viewer: View the scans for this order.
Add Rx: Add a prescription for this order (only applicable for Orthodontic
orders and available up to 21 days after a scan).
Invisalign doctors may also select Invisalign features such as Invisalign
Outcome Simulator.
Chapter 5:
Orders
In Progress
Past Orders
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Start a new scan
To start a new scan, press the New Scan icon from the home screen or
press the new scan button from the Patient page.
Prescription icon: The first step in the New Scan workflow. Fill out the
prescription form with patient information, case type, and any notes
to include.
Scan icon: The second step in the New Scan workflow. Scan the patient
for a new scan to be captured.
View and Review icon: The third step in the New Scan workflow. Inspect
the scan and examine that all adequate data has been captured.
Send Case icon: The final step in the New Scan workflow. Sign the
confirmation form and send the case to its destination for storage or
additional work needed.
For Restorative cases, select the case type and restoration needs for
the appropriate indication. For Orthodontic cases, such as Invisalign or
iRecord, select the case type and enter in patient information.
Chapter 6:
Scan
Patient information
Case Type
Notes
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After selecting the case type for a patient, please begin scanning.
To start a scan, tap the scan icon.
Scan feedback: To view any missing tooth, soft tissue, or oral structure
during the scan.
Color: To switch from scan to color view.
View finder: View the wand’s current positioning.
Toggle View: Toggle between displaying a color image or a NIRI image in
the viewfinder
Enlarge View: Switch to a large viewfinder in the middle of the screen
1
Select a lab to send the case
Select the restoration type
from the dropdown
1
2
Real time modeling
View finder
Color
Scan feedback
Toggle view
Enlarge view
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After reviewing the scan, sign the Rx form and send the scan to complete
the case.
Signature box: Sign your signature here with a finger. Check “Save
Signature” to store a signature away for future ease and use. Check
“Don’t show again” to eliminate this step.
Clear: To clear a signature from the signature box.
Confirm & Send: Confirm scan has been reviewed and send the scan to
a lab or iTero storage.
Signature box
Clear
Confirm & Send
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