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TRADEMARKS The following 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: Align Technology Inc., iTero ® Any other trademarks or registered trademarks appearing in this manual are the property of their respective owners.
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ENGLISH iTero ® Element Operation Manual ™ CLASS 1 LASER COMPLIANCE Class 1 Laser Product 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.
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FRANÇAIS Manuel d’utilisation iTero ® Element ™ CONFORMITÉ DU LASER CLASSE 1 Produit Laser de 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.
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Operation Manual ™ 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.
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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.
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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.
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électrique panneaux et couvercles externes. Il ne contient aucune pièce réparable par l’utilisateur. • Afin 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...
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.
™ 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.
ENGLISH iTero ® Element Operation Manual ™ CHAPTER 2: Basic Hardware Features CUSTOM WHEEL STAND HARDWARE FEATURES: Front View of the System Scanning Unit (Wand) Touch screen Scanning Unit (Cradle) Power LED Power Switch Wheel Base 2017 Align Technology, Inc.
ENGLISH iTero ® Element Operation Manual ™ CUSTOM WHEEL STAND HARDWARE FEATURES: Back View of the System Air Vents (Do not block back of system) Wi-Fi Antennas Power Inlet and Fuse Holder USB Socket for Optional Camera/DOK Scanning Unit Connector...
ENGLISH iTero ® Element Operation Manual ™ SCANNING UNIT (WAND) Air Vents Touchpad Side Buttons: Scan, On/Off, Touchpad Activation... Detachable Scanning Unit Cable with USB connector Disposable Sleeve Publication 109797 Align Technology, Inc. 2017...
ENGLISH iTero ® Element Operation Manual ™ 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.
ENGLISH iTero ® Element Operation Manual ™ CHAPTER 4: AC Power Problems–Troubleshooting CHECKING & REPLACING MAIN FUSES System Access Unplug Cord from Wall Move system away from any wall to allow easy access Unplug the power cord from the wall socket.
ENGLISH iTero ® Element Operation Manual ™ 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.
ENGLISH iTero ® Element Operation Manual ™ CLEANING AND DISINFECTANT MATERIALS for Scanning Unit and Base Unit The following cleaning and disinfectant materials are recommended for use for the Scanning Unit and the Base Unit. Description Manufacturer P/N Manufacturer ®...
ENGLISH iTero ® Element Operation Manual ™ CHAPTER 6: Changing Sleeves between Patients CLEANING AND DISINFECTING THE SCANNING UNIT (WAND) To avoid cross contamination, it is essential that after each patient you fully clean and disinfect the Scanning Unit and the disposable sleeve. First spray disinfectant material on towel or use disinfectant wipes to clean the Scanning Unit and Scanning Unit Cradle (holder).
Unit is not in use. Please keep the blue sleeve in a safe place so that it does not get lost or damaged. Scanner Sleeves may be ordered online in boxes of 25 from the iTero store. www.store.itero.com Publication 109797 Align Technology, Inc. 2017...
Guidance and Align Technology‘s Declaration – Electromagnetic Emissions – for iTero Element iTero Element is intended for use in the electromagnetic environment specified below. The customer or the user of iTero Element should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –...
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Life-Supporting The iTero Element is intended for use in the electromagnetic environment specified below. The customer or the user of the iTero Element should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic Environment –...
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Equipment and the iTero Element System that is not Life-Supporting iTero Element is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the iTero Element can help prevent electromagnetic interference by...
ENGLISH iTero ® Element Operation Manual ™ APPENDIX B: Hardware Specifications ITEM DESCRIPTION Monitor 19” monitor Scanner emits red laser light (680nm Class 1) as well as Scanner white LED emissions. LAN card provides local network communications with Wireless LAN wireless connectivity.
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