OPERATION MANUAL - Amazon Web Services

1 OPERATION MANUALiTero Element OPERATION ManualENGLISHP ublication 109797 Align Technology, Inc. 2019 Rev. FiCOPYRIGHT Copyright by Align Technology Inc. 2019 All rights 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 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 MANUAL describes the iTero Element Optical Impression Device.

2 English language version. Updated October 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 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: +1 (800) AUTHORIZED REPRESENTATIVEA lign Technology, 411014BV AmsterdamThe NetherlandsUSA OFFICEC orporate HeadquartersAlign Technology, Orchard ParkwaySan Jose, California : +1 (408) 470-1000 Fax: +1 (408) 470-1010 Align Technology Ariel Sharon BoulevardOr Yehuda 6037606 IsraelTel: +972 (3) 634-1441 Fax: +972 (3) 634-1440iTero Element OPERATION ManualENGLISH2019 Align Technology, Inc.

3 Publication 109797 Rev. FiiCLASS 1 LASER COMPLIANCE This device complies with: 21 CFR and EN 60825-1 .CSA COMPLIANCEThis 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 COMPLIANCEThis 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 ) This device must accept any interference received, Including interference that may cause undesired WarningModifications to the device that are not expressly approved by the manufacturer may void your authority to operate the device under FCC COMPLIANCEThis device complies with the following EMC standard.

4 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 COMPLIANCEThis device complies with the following safety standard: IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential COMPLIANCEThis device complies with Council Directive 93/42/EEC for Medical 1 Laser ProductC USManuel d utilisation iTero Element FRAN AISP ublication 109797 Align Technology, Inc. 2019 Rev. FiiiCONFORMIT DU LASER CLASSE 1 Cet appareil est conforme aux normes: 21 CFR et EN 60825-1.

5 CONFORMIT CSACe dispositif est conforme la norme CSA pour le Canada et les tats-Unis UL Std No. 60601-1 Second Edition Medical Electrical Equipment Part 1: General Require-ments for Safety CONFORMIT FCCCe dispositif est conforme l Article 15 des R glementations FCC et son fonctionne-ment est soumis aux conditions suivantes : 1) Ce dispositif ne doit pas causer d interf rences ) Ce dispositif doit accepter toute interf rence re ue, y compris des interf rences pouvant causer un FCCT oute modification apport e au dispositif n ayant pas t express ment approuv e par le fabricant peut annuler votre droit utiliser ce dispositif d apr s les R glementations CEMCet appareil est conforme aux normes de s curit CEM suivantes : IEC 60601-1-2 Dispositifs lectrom dicaux - Partie 1-2 : Exigences g n rales pour la s curit de base et les performances essentielles - Norme collat rale.

6 Ph nom nes lectromagn tiques - Prescriptions et essais S CURIT DU DISPOSITIFCet appareil est conforme aux normes de s curit suivantes : IEC 60601-1 Dispositifs lectrom dicaux Article 1 : Exigences g n rales pour la s curit de baseet les perfor-mances essentielles .CONFORMIT CECe dispositif est conforme la directive 93/42/CEE relative aux dispositifs m Laser de Classe 1C USiTero Element OPERATION ManualENGLISH2019 Align Technology, Inc. Publication 109797 Rev. FivSYMBOLS The following symbols may appear on iTero Element hardware components, and may also appear within this MANUAL and other iTero Element literature.

7 Wherever this symbol appears on the device, it is recommended to refer to this MANUAL for information on proper usage of the part type B. Any component on which this symbol appears is electric isolation type collection of electrical waste and electronic equipment is : 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 within this or accessories on which this symbol occurs should not be : US Federal Law restricts this device to sale by or on the order of a licensed Dentist, Orthodontist or Dental Professional.

8 The system serves as a prescription medi-cal device and should be operated by qualified health-care providers device manufacturer."Rx only"Manuel d utilisation iTero Element FRAN AISP ublication 109797 Align Technology, Inc. 2019 Rev. FvSYMBOLES Les symboles suivants peuvent appara tre sur des composants mat riels de l iTero Element tout comme dans ce manuel et d autres publications relatives l iTero Element. Lorsque ce symbole appara t sur le dispositif, il est recommand de vous reporter ce manuel pour des informations sur l utilisation appropri e de ce dispositif.

9 Pi ce appliqu e de type B. Tout composant sur lequel ce symbole appara t est une isolation lectrique de type est n cessaire de collecter s par ment les d chets d quipements lectriques et : Ce symbole est utilis pour souligner le fait qu il existe des avertissements ou pr cautions sp cifiques associ s ce dispositif. Lorsque ce symbole appara t sur le dispositif, il est obligatoire de vous reporter aux informations concernant la s curit dans ce pi ces ou accessoires sur lesquels ce symbole appara t ne doivent pas tre r util-is : La Loi f d rale des tats-Unis restreint la vente de ce dispositif par ou pour le compte d un dentiste, d un orthodontiste ou d un professionnel dentaire agr.

10 Le syst me sert de dispositif de prescription m dicale et devrait tre utilis uniquement par des prestataires de soins de sant qualifi du dispositif m dical"Rx only"iTero Element OPERATION ManualENGLISH2019 Align Technology, Inc. Publication 109797 Rev. FviSAFETY 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.