iTero Element User manual

OPERATION MANUAL

iTero®Element™Operation Manual ENGLISH
Publication 109797 Align Technology, Inc. 2017
i
COPYRIGHT
Copyright © by Align Technology Inc. 2017. 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 Inc.
This manual describes the iTero®Element™Optical Impression Device.
English language version. Updated December 2017.
TRADEMARKS
The following are trademarks and/or service marks of Align Technology, Inc. or one of its subsidiaries or
af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 manual are the property of their respective
owners.
CUSTOMER SUPPORT
Tel: [phone]
E-mail:
[email protected]
E-mail:
[email protected]
EUROPEAN AUTHORIZED REPRESENTATIVE
Obelis s.a.
Boulevard Général Wahis 53
B - 1030 Brussels, Belgium
www.obelis.net
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
USA OFFICE
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 OFFICE
International Headquarters
Align Technology B.V.
Arlandaweg 161
1043 HS Amsterdam
Tel: [phone]
Fax: [phone]

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CLASS 1 LASER COMPLIANCE
This device complies with: “21 CFR 1040.10” and “EN 60825-1”.
CSA COMPLIANCE
This device complies with the following CSA standard for Canada and the USA:
“UL Std No. 60601-1 Second Edition – Medical Electrical Equipment Part 1:
General Requirements for Safety”
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
Modications to the device that are not expressly approved by the manufacturer may void your
authority to operate the device under FCC Rules.
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”.
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.
CE COMPLIANCE
This device complies with Council Directive 93/42/EEC for Medical Devices.
Class 1 Laser Product
C US

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CONFORMITÉ DU LASER CLASSE 1
Cet appareil est conforme aux normes: “21 CFR 1040.10” et “EN 60825-1”.
CONFORMITÉ CSA
Ce dispositif est conforme à la norme CSA pour le Canada et les Ètats-Unis « UL Std
No. 60601-1 Second Edition – Medical Electrical Equipment Part 1: General Require-
ments for Safety »
CONFORMITÉ FCC
Ce dispositif est conforme à l’Article 15 des Réglementations FCC et son fonctionne-
ment est soumis aux conditions suivantes :
1) Ce dispositif ne doit pas causer d’interférences nuisibles.
2) Ce dispositif doit accepter toute interférence reçue, y compris des interférences
pouvant causer un dysfonctionnement.
Avertissement FCC
Toute modication apportée au dispositif n’ayant pas été expressément approuvée par le fabricant peut annuler
votre droit à utiliser ce dispositif d’après les Réglementations FCC.
CONFORMITÉ CEM
Cet appareil est conforme aux normes de sécurité CEM suivantes :
“IEC 60601-1-2 Dispositifs électromédicaux - Partie 1-2 : Exigences générales pour la sécurité de base et les
performances essentielles - Norme collatérale : Phénomènes électromagnétiques - Prescriptions et essais”
SÉCURITÉ DU DISPOSITIF
Cet appareil est conforme aux normes de sécurité suivantes :
“IEC 60601-1 Dispositifs électromédicaux – Article 1 : Exigences générales pour la sécurité de baseet les perfor-
mances essentielles”.
CONFORMITÉ CE
Ce dispositif est conforme à la directive 93/42/CEE relative aux dispositifs médicaux.
Produit Laser de Classe 1
C US

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SYMBOLS
The following symbols may appear on iTero Element hardware components, and may also appear within this
manual and other iTero Element literature.
Wherever this symbol appears on the device, it is recommended to refer to this manual
for information on proper usage of the device.
Applied part type B. Any component on which this symbol appears is electric isolation
type B.
Separate collection of electrical waste and electronic equipment is required.
Attention: This symbol is used to highlight the fact that there are specic warnings
or precautions associated with the device. Wherever this symbol appears on the device,
it is mandatory to refer to safety-related information within this manual.
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 medi-
cal device and should be operated by qualied health-care providers only.
Medical device manufacturer.
"Rx only"

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SYMBOLES
Les symboles suivants peuvent apparaître sur des composants matériels de l’iTero Element tout comme dans ce
manuel et d’autres publications relatives à l’iTero Element.
Lorsque ce symbole apparaît sur le dispositif, il est recommandé de vous reporter à ce
manuel pour des informations sur l’utilisation appropriée de ce dispositif.
Pièce appliquée de type B. Tout composant sur lequel ce symbole apparaît est une
isolation électrique de type B.
Il est nécessaire de collecter séparément les déchets d’équipements électriques et élec-
troniques.
Attention : Ce symbole est utilisé pour souligner le fait qu’il existe des avertissements
ou précautions spéciques associés à ce dispositif. Lorsque ce symbole apparaît sur
le dispositif, il est obligatoire de vous reporter aux informations concernant la sécurité
dans ce manuel.
Les pièces ou accessoires sur lesquels ce symbole apparaît ne doivent pas être réutil-
isés.
ATTENTION : La Loi fédérale des États-Unis restreint la vente de ce dispositif par ou
pour le compte d’un dentiste, d’un orthodontiste ou d’un professionnel dentaire agréé.
Le système sert de dispositif de prescription médicale et devrait être utilisé uniquement
par des prestataires de soins de santé qualiés.
Fabricant du dispositif médical
"Rx only"

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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.
Electric • Electric shock hazard!! Only authorized Align Technology technicians can remove
Warning external panels and covers. There are no user-serviceable parts inside.
• To avoid risk of electric shock, iTero Element must only be connected to a supply
mains with protective grounding.
• Only Align Technology approved Web Camera or DOK should be connected to
the USB socket on the back side of the System.
Wireless LAN • The system comes equipped with a Wireless LAN unit.
Safety • Type of protection against electrical shock: Class 1.
Classications • Degree of protection against electrical shock: Type B.
• Degree of protection against harmful ingress of water: Ordinary.
• Equipment not suitable for use in presence of ammable anesthetic mixtures.
• Mode of operation: Continuous.
Prescription • The system serves as a prescription medical device and should be operated by
Health Device qualied health-care providers only.
Scanner • The scanner emits red laser light (680nm Class 1) as well as white LED emissions. Normal
Warnings usage of the scanner does not present any danger to the human eye. However, doctors
should refrain from shining the scanner directly into the patient’s eyes.
• Avoid twisting cable, knotting cable, pulling on cable, stepping on cable.
• When the system is not in use, the scanning unit should be placed inside the holder with
the probe facing to the rear side of the touchscreen so there will be no eye contact with
the laser beam in any case.
Cleaning & • To avoid cross contamination, it is mandatory that after each patient session the
Disinfection disposable plastic sleeve be replaced and the scanning unit be disinfected.
• Dispose of scanner sleeves according to standard operating procedures or local
regulations for the disposal of contaminated medical waste.
Unpacking & • The system should be unpacked and installed following Align Technology’s instructions.
Installing
Work • The system should be moved between rooms with utmost care to avoid damage.
Environment • Do not block the air vents on the Scanning Unit and Base Unit.
• System is intended for indoor use only. It should not be exposed to direct sunlight,
excessive heat or humidity.
Electro • WARNING: This device has been tested and found to comply with the requirements for
Magnetic medical devices according to standard EN60601-1-2. This standard is designed to
Interference 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 noise in the healthcare environments
(e.g., cellular phones, mobile two-way radios, electrical appliances), 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.
General • WARNING: No modication of this equipment is allowed.
• WARNING: The touchscreen always needs to be in a stand while in operation!

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CONSIGNES DE SÉCURITÉ
Avant de commencer à travailler avec le système, tous les utilisateurs doivent lire les consignes de sécurité.
Alimentation • L’alimentation électrique est fournie au système via une alimentation interne pour le milieu
médical.
Avertissement • Danger d’électrocution !! Seuls les techniciens Align autorisés peuvent retirer les
électrique panneaux et couvercles externes. Il ne contient aucune pièce réparable par l’utilisateur.
• An d’éviter les risques d’électrocution, l’ iTero® Element™ doit uniquement être connecté
au secteur par une mise à la terre de protection.
• Uniquement la webcam (approuvée par Align Technology) ou des clés USB peuvent être
connectées au port USB à l’arrière du dispositif.
Réseau Local • L’appareil est livré équipé d’une unité locale sans l.
Sans Fil
Classications • Type de protection contre l’électrocution : Classe 1.
de Sécurité • Degré de protection contre l’électrocution : Type B.
• Degré de protection contre la pénétration d’eau nuisible : Normal.
• Dispositif ne convenant pas à une utilisation en présence de mélanges d’anesthésiques
inammables.
• Mode de fonctionnement : Continu.
Dispositif de • Le système sert de dispositif de prescription médicale et devrait être utilisé uniquement
Prescription par des prestataires de soins de santé qualiés.
Médicale
Avertissements • Le scanner émet une lumière laser rouge (680 nm Classe 1) ainsi que de la lumière blanche
concernant via des DEL. Une utilisation normale du scanner ne présente aucun danger pour l’œil
le scanner humain. Cependant, les praticiens devraient s’abstenir d’éclairer les yeux du patient
directement avec le scanner.
• Évitez de tordre le câble, de faire des nœuds, de tirer dessus ou bien de marcher dessus.
• Lorsque le système n’est pas utilisé, l’unité de balayage devrait être placée dans le support
prévu à cet effet avec la sonde tournée du côté de la face arrière du moniteur an d’éviter
tout contact entre le faisceau laser et les yeux.
Nettoyage et • Pour éviter toute contamination croisée, il est obligatoire de remplacer le manchon jetable
Désinfection en plastique après chaque session avec un patient et de désinfecter l’unité de balayage.
• Jetez les manchons en plastique du scanner selon les procédures normalisées ou les
réglementations locales concernant les déchets médicaux contaminés.
Déballage et • Le dispositif devrait être déballé et installé selon les instructions d’Align.
Installation
Environnement • Le dispositif doit être déplacé d’une pièce à l’autre avec la plus grande précaution an
de Travail d’éviter de l’endommageren faisant preuve du plus grand soin.
• Ne bloquez pas les ouvertures d’aération sur les unités de balayage et de base.
• Le système est destiné à être utilisé en intérieur uniquement. Il ne doit pas être exposé
directement à la lumière du soleil, ni à une chaleur excessive ou à l’humidité.
Interférence • AVERTISSEMENT : Ce dispositif a été testé et est conforme aux exigences concernant les
dispositifs médicaux d’après la norme EN60601-1-2. Cette norme est destinée à apporter
une protection raisonnable contre des interférences nuisibles dans une installation médicale
typique. Cependant, en raison de la prolifération d’équipements transmettant des rdio-
fréquences et d’autres sources de bruit électrique dans les environnements liés à la santé
(téléphones portables, radios mobiles bidirectionnelles, appareils électriques), il est possible
que des niveaux élevés d’interférences dues à la proximité ou à la puissance de la source
entraînent une perturbation de la performance de ce dispositif.
General • AVERTISSEMENT : Aucune modication de ce dispositif n’est autorisée.
• AVERTISSEMENT : NE PAS UTILISER le moniteur en position horizontale !

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TABLE OF CONTENTS
CHAPTER 1: Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
About this Operation Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Benets of the iTero Element System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
The iTero Element User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
CHAPTER 2: Basic Hardware Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Front View of the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Back View of the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Custom Counter Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Scanning Unit (Wand) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
CHAPTER 3: Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Initial Power-Up and Boot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
End-of-Day Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Moving System within the Ofce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
CHAPTER 4: AC Power Problems—Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . 9
Checking & Replacing Main Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
CHAPTER 5: Scanner Handling, Cleaning, and Disinfection Instructions . . . . . . . . . . . . 10
Handling of the Scanning Unit (Wand) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Handling of the Scanning Unit Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Recommended Best Practices for Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . 10
Cleaning and Disinfectant Materials for Scanning Unit and Base Unit . . . . . . . . . . . . . . . . . 11
CHAPTER 6: Changing Sleeves between Patients . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Cleaning and Disinfecting the Scanning Unit (Wand) . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Replacing Disposable Sleeves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Scanner Sleeves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
APPENDIX A: EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
APPENDIX B: Hardware Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

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CHAPTER 1:
Introduction
About this Operation Manual
The iTero Element system is delivered as a proprietary, PC-based workstation for performing
intra oral scans in the doctor’s ofce. This Operation Manual describes how to boot and shut
down the system, how to correctly handle the Scanning Unit/Wand and cable, and how to
clean the Scanning Unit and replace its sleeves between patients.
Intended Use
iTero Element is an optical impression system (CAD/CAM) used 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.
iTero Element software is used with the iTero Element scanner in capturing 3D digital
impressions of teeth, oral soft tissue and structures, and bite relationship. The 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 verication and
service of the system and to serve as an order management tool.
Benets of the iTero Element System
The iTero Element system provides important advantages over existing crown-production
methods, Including powder-free scanning, greater crown-production accuracy, and
immediate feedback during the scanning process.
Refer to our website http://www.itero.com to learn how the iTero Service can enhance your
business by Increasing patient satisfaction, improving clinical outcomes, and enhancing ofce
efciency.

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The iTero Element User Interface
The iTero Element system provides an intuitive user interface for performing digital scans
for Restorative or Orthodontic use. The doctor is guided through the scanning sequence by
means of visual and text assistance. The touchscreen and wand buttons are used to respond
to screen instructions during the scanning process.
One tap on the question mark will enable a transparent Help overlay that will provide
a brief overview. Please note that the Headset image appears instead of the question
mark while in this view. Tap anywhere to close the help screen and return to the
relevant screen.
Tap to enter the Learning Center or start training
Tap anywhere on screen
to close this help overlay
(Tap to start a new case) (Tap to see/search patient list)
Tap to lock the desktop
Tap to set your preferences Double tap to connect
to a support agent for
remote troubleshooting
(please call support rst)
Tap to view notications,
updates and other messages
from Align Technology
Tap to check the
status of your orders

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CHAPTER 2:
Basic Hardware Features
CUSTOM WHEEL STAND HARDWARE FEATURES: Front View of the System
Wheel Base
Scanning Unit (Wand)
Scanning Unit
(Cradle)
Power LED
Power Switch
Touch screen

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USB Socket
for Optional
Camera/DOK
Scanning Unit
Connector
CUSTOM WHEEL STAND HARDWARE FEATURES: Back View of the System
Air Vents
(Do not block
back of system)
Power Inlet
and Fuse Holder
Wi-Fi Antennas
Power Cord

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CUSTOM COUNTER STAND: Front and Back View of the System

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SCANNING UNIT (WAND)
Touchpad
Disposable Sleeve
Detachable Scanning
Unit Cable with USB
connector
Side Buttons:
Scan, On/Off,
Touchpad Activation...
Air Vents

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CHAPTER 3:
Operating Instructions
INITIAL POWER-UP AND BOOT
Plug main cable into the Base Unit socket and other end into wall outlet;
Plug free end of Wheel Stand main cable into wall socket.
Press and release the power switch on the bottom of the screen frame, on
the right side. The power LED will turn on.
It is recommended to keep the system in operation during ofce hours to allow background
le transfers between the doctor’s ofce, the doctor’s partnered labs, and the Align
Technology Center. It is recommended to shut down the system at the end of the day,
and to reboot in the morning.
END-OF-DAY SHUT DOWN
Close all les and applications.
Press and release the Power Switch on the bottom of the screen to shut down the system.
MOVING SYSTEM WITHIN THE OFFICE
To ensure maximum system protection, it is recommended to have two people move
the system. Follow these instructions for relocating the system:
1Verify the Scanning Unit (Wand) sits well inside the Scanning Unit Cradle (holder).
2Press and release the Power Switch on the bottom of the screen to shut down the system.
3Unplug system from the wall outlet.
4Move the system carefully using two people.
5Place the system at its new location and it plug into a wall outlet.
6Press and release the power switch to power ON the system.
1
11
2
3
2

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System Access
Move system away from any wall to allow easy access
to the power cord and fuse tray.
View Fuse Tray
The fuse tray is located below the power socket.
Remove & Check Fuses
Carefully remove each fuse from the tray.
Check fuses visually (and with tester if available).
Close Fuse Tray
Close the fuse tray and insert cord rmly.
CHAPTER 4:
AC Power Problems–Troubleshooting
CHECKING & REPLACING MAIN FUSES
Unplug Cord from Wall
Unplug the power cord from the wall socket.
Disconnect Cord from Base Unit
Unplug the power cord from the back of the system.
Open Fuse Tray
Push down on the small plastic part on the fuse
tray to release it, then pull the fuse tray out.
Replace Fuse
If either fuse is blown or suspect, replace both fuses
(See “Fuse Type” specs at the end of the manual.)
1
3
5
7
2
4
6
8

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CHAPTER 5:
Scanner Handling, Cleaning, and
Disinfection Instructions
HANDLING OF THE SCANNING UNIT (WAND)
•The Scanning Unit contains delicate components and should be handled with care.
HANDLING OF THE SCANNING UNIT CABLE
•The scanner cable should be treated with care to avoid possible damage.
•Avoid twisting, knotting, pulling or stepping on cable, etc.
•Between patient sessions, it is recommended to undo any twists and knots in order to
relieve all tension from the scanner cable
RECOMENDED BEST PRACTICES FOR CLEANING AND DISINFECTING
the Scanning Unit, Base Unit, Wheel Stand and/or Counter Stand in between patients.
• Do not spray disinfectant directly on scanner system surfaces.
• Spray the disinfectant on a towel, or use disinfectant wipes for the Scanning Unit,
and Base Unit.
• Warning: over saturation of disinfectant product on the scanner system surfaces may
cause damage, including internal components.
• Follow the disinfectant manufacturers’ instructions for appropriate contact time.
Remove residual liquid disinfectant with a lint-free, clean cloth.
• Note: follow standard precautions for personal protection, as appropriate.
• Warning: DO NOT touch the optical surface of the Scanning Unit (Wand).