Align Technology iTero Element 5D User Manual
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Align Technology iTero Element 5D User Manual

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  • Page 1 Element 5D iTero Element 5D Plus imaging systems User manual it starts with...
  • Page 3 Element 5D and iTero Element 5D Plus imaging systems User manual Copyright Patents © 2022 Align Technology, Inc. All rights reserved. www.aligntech.com/patents The information contained in this manual is subject to Trademarks change without notice. Align, Invisalign, ClinCheck and iTero among others, are...
  • Page 4 Element 5D and iTero Element 5D Plus imaging systems User manual Contraindications For persons who have been diagnosed with Epilepsy, there is a risk of epileptic shock from the flashing light of the iTero scanner. These persons should refrain from any eye contact with the flashing light associated with the system during operation.
  • Page 5 62471 and IEC 60825-1. Symbols The following symbols may appear on iTero Element 5D and iTero Element 5D Plus hardware components and may appear within this document and other iTero Element literature. CAUTION: US Federal Law restricts this device to sale Follow instructions for use.
  • Page 6 Element 5D and iTero Element 5D Plus imaging systems User manual Temperature limit. Batch code. Medical device. Atmospheric pressure limitation. Consult the electronic instructions for use. Humidity limitation. USB socket. Fragile, handle with care. Electric battery. This side should be up.
  • Page 7 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 a medical-grade power supply. In iTero Element 5D Plus cart configurations, the power supply is enclosed in the base of the wheel stand. In iTero Element 5D Plus mobile configurations, the power supply is external.
  • Page 8 Element 5D and iTero Element 5D Plus imaging systems User manual The system comes equipped with a wireless LAN unit. Wireless LAN When using the product, maintain a separation distance of at least 20cm between the computing unit and all persons' bodies to ensure compliance with RF exposure requirements.
  • Page 9 The system is intended for indoor use only. It should not be exposed to direct sunlight, excessive heat, or humidity. iTero Element 5D laptop configuration only: If the system has just been brought into the office from a hot, cold, or humid environment, it should be set aside until it has adjusted to the room temperature, to avoid internal condensation.
  • Page 10 Element 5D and iTero Element 5D Plus imaging systems User manual Contre-indications – French Pour les personnes ayant un diagnostic d’épilepsie, la lumière clignotante du scanner iTero peut engendrer un risque de choc épileptique. Ces personnes doivent éviter tout contact visuel avec la lumière clignotante inhérente au système pendant le fonctionnement.
  • Page 11 IEC 62471 et IEC 60825-1. Symboles – French Les symboles suivants peuvent apparaître sur les composants électroniques iTero Element 5D et iTero Element 5D Plus et peuvent apparaître dans ce document et dans d'autres documents iTero Element.
  • Page 12 Element 5D and iTero Element 5D Plus imaging systems User manual Ne pas réutiliser. Limite de température. Code du lot Dispositif médical. Limite de pression atmosphérique Consultez les instructions d'utilisation électroniques. Limite d'humidité Prise USB. Fragile, à manipuler avec soin.
  • Page 13 électrique configurations de iTero Element 5D Plus chariot, l'alimentation électrique est enfermée dans la base du support de roue. Dans les configurations iTero Element 5D Plus mobiles, l'alimentation est externe. Charge - la batterie du scanner sera complètement chargée après avoir été branchée à...
  • Page 14 Element 5D and iTero Element 5D Plus imaging systems User manual Ne connectez jamais le hub à un ordinateur portable qui ne respecte pas les normes IEC60950 et UL60950-1. L'ordinateur portable et tous ses accessoires doivent être situés à au moins 1,5 m du patient. Ne numérisez pas un patient en même temps que vous touchez l'ordinateur portable ou l'un de ses accessoires.
  • Page 15 Configurations chariot et support à roue uniquement: Ne retirez pas l'unité de traitement du support après l'assemblage. Notification Tout incident grave lié à l'appareil iTero doit être signalé à Align Technology Ltd. et à d'incident l'autorité compétente du pays dans lequel l'utilisateur et le patient sont établis.
  • Page 16 Element 5D and iTero Element 5D Plus imaging systems User manual © 2022 Align Technology, Inc. All rights reserved.

  • Page 17: Table Of Contents

    Assembling the iTero Element 5D laptop configuration scanner 2.2.1 Installing the iTero Element 5D software – laptop configuration Assembling the iTero Element 5D Plus and 5D Plus Lite scanner – cart configuration Assembling the iTero Element 5D Plus and 5D Plus Lite scanner – mobile configuration 2.4.1 Initial assembly 2.4.2...
  • Page 18 Element 5D and iTero Element 5D Plus imaging systems User manual Working in Demo Mode 3.3.1 Exiting Demo Mode Working with the scanner Logging in to the scanner 4.1.1 Resetting your password 4.1.2 Installing Windows security updates Logging out of the scanner...
  • Page 19 Element 5D and iTero Element 5D Plus imaging systems User manual 5.5.2 Scanning best practices 5.5.3 Scan options 5.5.4 Toggling the 3D and viewfinder display 5.5.5 Toggling between color and NIRI images in the viewfinder 5.5.6 Editing a scan Viewing the scan 5.6.1...
  • Page 20 Element 5D and iTero Element 5D Plus imaging systems User manual 10.10 Working with the Margin Line tool 10.10.1 Automatically defining the margin line 10.10.2 Manually defining the margin line 10.11 Working with the Review tool (iTero Element 5D and 5D Plus) 10.11.1...
  • Page 21 Element 5D and iTero Element 5D Plus imaging systems User manual EMC declarations EMC declaration – iTero Element 5D EMC declaration – iTero Element 5D Plus iTero Element product security whitepaper System specifications iTero Element 5D wheel-stand configuration system specifications...
  • Page 22 Figure 2: Rear view of the iTero Element 5Dimaging system Figure 3: iTero Element 5D laptop configuration imaging system Figure 4: Front view of the iTero Element 5D Plus cart-configuration imaging system Figure 5: Rear view of the iTero Element 5D Plus cart-configuration imaging system...
  • Page 23 Figure 44: Login window with notification about Windows security updates Figure 45: Home screen with notification about Windows security updates Figure 46: iTero Element 5D laptop configuration imaging system in the supplied carrying case Figure 47: Moving the scanner Figure 48: Carrying the scanner between rooms within the clinic...
  • Page 24 Element 5D and iTero Element 5D Plus imaging systems User manual Figure 68: Rx Settings window – NIRI Captures option disabled Figure 69: Signature Settings window Figure 70: Language Settings window Figure 71: Login Settings window Figure 72: Diagnostics window Figure 73: Licensing Information window Figure 74: System Information window –...
  • Page 25 Element 5D and iTero Element 5D Plus imaging systems User manual Figure 103: Check box confirming a new sleeve Figure 104: Popup confirmation message before scanning Figure 105: Recommended scanning sequence – lower jaw Figure 106: Wand guidance Figure 107: Areas with missing anatomy shown with and without additional scan feedback – monochrome Figure 108: Areas with missing anatomy shown with and without additional scan feedback –...
  • Page 26 Element 5D and iTero Element 5D Plus imaging systems User manual Figure 138: Past Orders pane – options Figure 139: Orders button notifying a returned order Figure 140: Returned order in the In Progress pane Figure 141: Messages page Figure 142: iTero TimeLapse –...
  • Page 27 Figure 205: Wipe the optical surface of the wand with IPA Figure 206: iTero Element 5D – Remove gross contaminants on the cradle using CaviWipes1 Figure 207: iTero Element 5D Plus cart – Remove gross contaminants on the cradle using CaviWipes1 © 2022 Align Technology, Inc. All rights reserved.
  • Page 28 Figure 208: iTero Element 5D Plus mobile – Remove gross contaminants on the cradle using CaviWipes1 Figure 209: iTero Element 5D – Remove remaining marks and stains on the cradle using the soft bristle brush 189 Figure 210: iTero Element 5D Plus cart – Remove remaining marks and stains on the cradle using the soft bristle brush Figure 211: iTero Element 5D Plus mobile –...

  • Page 29: Introduction To Itero Element 5D And Itero Element 5D Plus Imaging Systems

    Element 5D can also be used as a wand-only configuration with any laptop that meets our minimum system requirements (see...

  • Page 30: Intended Purpose/Intended Use

    Element 5D and iTero Element 5D Plus imaging systems User manual Intended purpose/Intended use The iTero Element 5D and iTero Element 5D Plus imaging systems are intraoral scanners with the following features and intended use: The optical impression (CAD/CAM) feature of the scanner is intended/indicated for use to record the topographical images of teeth and oral tissue.

  • Page 31: Clinical Benefits

    Digital impressions improve patient comfort, accuracy, and speed of process as compared to conventional impressions. The iTero Element 5D and iTero Element 5D Plus imaging systems aid in the detection and monitoring of interproximal carious lesions above the gingiva without using harmful radiation.

  • Page 32: Itero Element 5D Wheel-Stand Configuration

    Element 5D and iTero Element 5D Plus imaging systems User manual 1.8.1 iTero Element 5D wheel-stand configuration Front view of the system Full HD Touch screen Power switch Power LED Wand Cradle Wheel base Figure 1: Front view of the iTero Element 5D imaging system...

  • Page 33: Itero Element 5D Laptop Configuration

    Element 5D and iTero Element 5D Plus imaging systems User manual Rear view of the system Wand connector Wand cable Screen power cable Figure 2: Rear view of the iTero Element 5Dimaging system 1.8.2 iTero Element 5D laptop configuration...

  • Page 34: Itero Element 5D Plus Cart Configuration

    Element 5D Plus cart configuration Front view Full HD touchscreen Power switch Main handle Wand Cradle Wheel stand Figure 4: Front view of the iTero Element 5D Plus cart-configuration imaging system © 2022 Align Technology, Inc. All rights reserved.

  • Page 35: Itero Element 5D Plus Mobile Configuration

    Rear view Wand connector Diagnostics panel (for Support purposes only) Upper handle New-sleeve basket Figure 5: Rear view of the iTero Element 5D Plus cart-configuration imaging system 1.8.4 iTero Element 5D Plus mobile configuration Front view Full HD touch-screen computing unit...

  • Page 36: Itero Element 5D Wand

    Power switch Cradle release button Locking latch Carrying handle/stand Wand cable Power cable Figure 7: Rear view of the iTero Element 5D Plus mobile-configuration imaging system 1.8.5 iTero Element 5D wand Disposable sleeve Touchpad Side buttons: Scan, on/off, touchpad activation...

  • Page 37: Itero Element 5D, Itero Element 5D Plus, And 5D Plus Lite Software

    Figure 10: Disposable sleeve iTero Element 5D, iTero Element 5D Plus, and 5D Plus Lite software The iTero Element 5D, iTero Element 5D Plus, and 5D Plus Lite imaging systems contain the following exclusive software features: Confirming a new wand sleeve between patients...

  • Page 38: 1.10 Working With Itero Near Infra-Red Imaging (Niri) Technology

    Element 5D and iTero Element 5D Plus imaging systems User manual 1.10 Working with iTero near infra-red imaging (NIRI) technology Note: This section is not relevant for iTero Element 5D Plus Lite systems. NIRI is a method of spectroscopy that uses the near-infrared region of the electromagnetic spectrum (850nm).

  • Page 39: Figure 13: Interproximal Carious Lesion

    NIR images are captured automatically and seamlessly during the scan, from every angle used for the 3D scanning, and all collected information can then be reviewed using the iTero Element 5D Review tool. Note: NIR images should be used in conjunction with the current standard of care for caries detection, and do not replace it.

  • Page 40: 1.10.1 Itero Niri Technology Limitations

    For more information on using iTero NIRI technology, please refer to the iTero Element 5D Clinical Guide. 1.11 About this manual This manual provides general information and an overview of the iTero Element 5D and iTero Element 5D Plus imaging systems and software. iTero Element 5D Plus imaging systems with the iTero Element 5D Plus Lite software package provide the same features and benefits as the iTero Element 5D Plus systems, including the 3D intraoral camera, but without the iTero NIRI functionality.

  • Page 41: Assembly Instructions

    Assembling the iTero Element 5D wheel-stand configuration scanner Assembling the iTero Element 5D laptop configuration scanner Assembling the iTero Element 5D Plus and 5D Plus Lite scanner – cart configuration Assembling the iTero Element 5D Plus and 5D Plus Lite scanner – mobile configuration...

  • Page 42: Assembling The Itero Element 5D Wheel-Stand Configuration Scanner

    Element 5D and iTero Element 5D Plus imaging systems User manual Assembling the iTero Element 5D wheel-stand configuration scanner Follow the instructions below to assemble the iTero Element 5D wheel-stand configuration scanner. 2 people are AC power Battery Click...
  • Page 43 Element 5D and iTero Element 5D Plus imaging systems User manual 3. Tighten the two Allen screws using 4. Remove the cover from the back of 5. Attach the wand cradle to the front the larger Allen key. the handle.
  • Page 44 Element 5D and iTero Element 5D Plus imaging systems User manual 12. Lift the touch screen to mount it. 13. Turn the scanner around and 14. Connect the power cable to the port tighten the thumbscrew to secure labeled DC, as shown in the next the screen.
  • Page 45 Element 5D and iTero Element 5D Plus imaging systems User manual 20. Position the webcam on the touch 21. Connect the webcam to the USB 22. Plug the power cable into the AC screen for remote training or port at the bottom of the touch power outlet and then press the support sessions.

  • Page 46: Assembling The Itero Element 5D Laptop Configuration Scanner

    The laptop should be connected to an AC wall outlet during intraoral scanning. 2.2.1 Installing the iTero Element 5D software – laptop configuration New iTero Element 5D wheel-stand configuration systems come with the software installed, but the user must install the software on iTero Element 5D laptop configuration systems. Notes: Before installing the iTero software, please install all available Windows updates.
  • Page 47 Element 5D and iTero Element 5D Plus imaging systems User manual For proper software installation and configuration of the iTero Element 5D laptop configuration system, please ensure the following: The wand is secure in the cradle and connected to the hub...

  • Page 48: Assembling The Itero Element 5D Plus And 5D Plus Lite Scanner - Cart Configuration

    Element 5D and iTero Element 5D Plus imaging systems User manual Assembling the iTero Element 5D Plus and 5D Plus Lite scanner – cart configuration The scanner packaging is designed in a way that provides a simple and easy assembly process.
  • Page 49 Element 5D and iTero Element 5D Plus imaging systems User manual 1. Remove the foam covering the 3. Attach the wheel base (C) to the 4. Move the wheel stand to an post (B). end of the post (B) and tighten...
  • Page 50 Element 5D and iTero Element 5D Plus imaging systems User manual 8. Attach the cradle (G) to the post 9. Carefully remove the computing 10. Standing behind the wheel stand, (B), and tighten using the small unit (H) from its protective mount the computing unit on the Allen key.

  • Page 51: Figure 14: Removing The Wand From The Cradle

    Element 5D and iTero Element 5D Plus imaging systems User manual 15. Secure the power cable (J) in 16. For remote training or support 17. Plug the power cable (J) into a the two cable clips, making sure sessions, position the webcam power outlet and then press the it is fully inserted.

  • Page 52: Figure 15: Moving The Scanner

    Element 5D and iTero Element 5D Plus imaging systems User manual When moving the scanner, carefully wrap the power If the scanner needs to be lifted, use the upper handle cable around the upper handle and then use the upper and the post.

  • Page 53: Assembling The Itero Element 5D Plus And 5D Plus Lite Scanner - Mobile Configuration

    Element 5D and iTero Element 5D Plus imaging systems User manual Assembling the iTero Element 5D Plus and 5D Plus Lite scanner – mobile configuration The scanner packaging is designed in a way that provides a simple and easy assembly process.

  • Page 54: Initial Assembly

    Element 5D and iTero Element 5D Plus imaging systems User manual 2.4.1 Initial assembly 1. Lay the iTero trolley down, with the 3. Rest the computing unit on a 4. Move the handle down to standing iTero logo facing up.
  • Page 55 Element 5D and iTero Element 5D Plus imaging systems User manual 8. Connect the power cable to the 9. For remote training or support 10. Press the power button to turn on power supply. Connect the one side sessions, position the webcam on the scanner.

  • Page 56: Moving The Scanner Within The Clinic

    Element 5D and iTero Element 5D Plus imaging systems User manual 2.4.2 Moving the scanner within the clinic 1. Disconnect the power cable. 2. While holding the computing unit 3. Loosely wrap the wand cable with one hand, slide the locking...
  • Page 57 Element 5D and iTero Element 5D Plus imaging systems User manual 4. While holding the computing unit 5. Place the cradle in the trolley. 6. Optional: Place new sleeves in the with one hand, remove the cradle compartment below the cradle.

  • Page 58: Optional Protective Cover

    Element 5D and iTero Element 5D Plus imaging systems User manual Notes: The trolley must be handled with care. Avoid leaving the trolley in the sun in order to prevent the scanner from reaching extreme temperatures. Make sure the trolley is kept dry to protect the system components from humidity.
  • Page 59 Element 5D and iTero Element 5D Plus imaging systems User manual 1. Lay the computing unit face down 2. Remove the iTero back cover plate 3. Connect the computing unit to the on a smooth, flat surface. to expose the VESA screw holes. (It...

  • Page 60: Figure 17: Do Not Allow The Power Pack To Dangle In The Air

    Element 5D and iTero Element 5D Plus imaging systems User manual Notes: Ensure that the power pack rests on the floor or on a table and does not dangle in the air. Figure 17: Do not allow the power pack to dangle in the air Never tilt the screen more than 45 degrees to make sure that the wand does not slip out of the cradle.

  • Page 61: Getting Started

    Element 5D and iTero Element 5D Plus imaging systems User manual Getting started Logging in to the scanner for the first time When you turn on the scanner for the first time, the Welcome screen is displayed: Figure 19: Welcome screen Select the required language and one of the following modes: Make It Mine: Enables you to register the scanner.

  • Page 62: Figure 20: Connect Page Listing The Available Networks

    Element 5D and iTero Element 5D Plus imaging systems User manual You will receive an email from an iTero representative with login credentials and detailed information on how to proceed with the Make It Mine process. Note: If you accessed the Demo Mode from the Welcome page before registering the scanner, you will have to restart the scanner to access the Make It Mine option.

  • Page 63: Figure 21: Entering The Security Key

    Element 5D and iTero Element 5D Plus imaging systems User manual 3. Select the clinic network from the list and then tap Connect. You are prompted to enter the network security key. Figure 21: Entering the security key 4. Enter the security key and then tap Connect.

  • Page 64: Figure 23: Verifying The Communication With Align

    Element 5D and iTero Element 5D Plus imaging systems User manual 5. Tap Next. The communication with Align is verified. Figure 23: Verifying the communication with Align 6. When the verification is complete, tap Next. The Time Zone page is displayed.

  • Page 65: Figure 25: Registering The System To Customize The Setup

    Element 5D and iTero Element 5D Plus imaging systems User manual 7. Tap Next if the default time zone is correct or select the time zone from the drop-down list and then tap Apply. The Register System page is displayed.

  • Page 66: Figure 27: License Agreement

    Element 5D and iTero Element 5D Plus imaging systems User manual 9. Tap Next. The License Agreement page is displayed. Figure 27: License agreement 10. After reviewing the license agreement, select the check box to accept the terms of the agreement and then tap Next.

  • Page 67: Working In Demo Mode

    In addition, demo cases that can be used for demonstration and training purposes of the iTero Element 5D Review tool and clinical indications shown by NIRI, are displayed. Note: NIRI technology is not supported by iTero Element 5D Plus Lite systems.

  • Page 68: Figure 30: Itero Element Logo

    Element 5D and iTero Element 5D Plus imaging systems User manual To enter Demo Mode after logging in: 1. Tap the iTero Element logo at the top of the scanner screen. Figure 30: iTero Element logo 2. Tap Demo Mode.

  • Page 69: Figure 32: Login Window With A List Of Demo Users

    Element 5D and iTero Element 5D Plus imaging systems User manual The Login window is displayed, enabling you to select the demo user. Figure 32: Login window with a list of demo users 3. To view iTero restorative cases, select the Dr. Demo, iTero user from the Doctor Name drop-down list.

  • Page 70: Figure 34: Demo Mode Home Screen

    Element 5D and iTero Element 5D Plus imaging systems User manual 4. Tap Demo Login. The Demo Mode home screen is displayed, with Demo Mode shown on the top left of the window. Figure 34: Demo Mode home screen 5.

  • Page 71: Figure 35: Past Orders Pane - Options

    The selected case is expanded to show the following options: Figure 35: Past Orders pane – options Note: The NIRI column is not displayed for iTero Element 5D Plus Lite systems. For more information on working with orders, see Working with orders...

  • Page 72: Exiting Demo Mode

    Element 5D and iTero Element 5D Plus imaging systems User manual 3.3.1 Exiting Demo Mode To exit Demo mode: Tap the iTero Element logo and then tap Exit Demo to exit the demo mode. Figure 36: Exiting Demo mode...

  • Page 73: Working With The Scanner

    Element 5D and iTero Element 5D Plus imaging systems User manual Working with the scanner Logging in to the scanner When the scanner is powered on, the Login window is displayed. Figure 37: Login window Make sure you have your MyAligntech account information ready when logging in to the iTero scanner. You need your name, account email, and password.

  • Page 74: Figure 38: Unexpected Shutdown Notification

    Element 5D and iTero Element 5D Plus imaging systems User manual If you did not shut down the scanner correctly previously, a message will be displayed notifying you of this and will remain until you acknowledge the message by tapping I UNDERSTAND. For more information on shutting...

  • Page 75: Figure 39: Password Is Masked

    Element 5D and iTero Element 5D Plus imaging systems User manual The text is masked as asterisks. Figure 39: Password is masked If you have forgotten your password, you can reset it, as described in Resetting your password. 4. Select the Remember Me check box for the system to remember your email address in future sessions. You will still need to enter your password in order to access the scanner.

  • Page 76: Figure 40: Itero Home Screen

    Element 5D and iTero Element 5D Plus imaging systems User manual The iTero home screen is displayed. Figure 40: iTero home screen Note: In order to ensure that all Windows security patches are up-to-date, a notification is displayed at the bottom of the Login window and home screen as soon as security updates are available.

  • Page 77: Resetting Your Password

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.1.1 Resetting your password You can reset your password, if required. To reset your password: 1. In the Login window, tap Forgot Password. Figure 41: Forgot Password button A window is displayed, describing what you should do next.

  • Page 78: Figure 43: Security Answer Field

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. In the Email field, enter the email address you used to register to myaligntech.com. 3. Tap Submit. Your predetermined security question is displayed. Figure 43: Security answer field 4.

  • Page 79: Installing Windows Security Updates

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.1.2 Installing Windows security updates Whenever the iTero software is upgraded, any relevant Windows security updates will be downloaded on the scanner and will be available for installation, in order to support the continuous cyber security of the scanner.

  • Page 80: Logging Out Of The Scanner

    Element 5D and iTero Element 5D Plus imaging systems User manual Figure 45: Home screen with notification about Windows security updates A Windows progress bar is displayed during the installation. Once the updates have been installed, the scanner restarts and the Login page is displayed.

  • Page 81: Shutting Down The Scanner

    Press and release the Power button to shut down the system. The Power button is located on the bottom right of the screen in iTero Element 5D systems and on the top right of the screen in iTero Element 5D Plus systems.

  • Page 82: Moving The Itero Element 5D Plus Cart-Configuration Scanner

    2. Place all items in the supplied carrying case to move the system between offices. Figure 46: iTero Element 5D laptop configuration imaging system in the supplied carrying case 3. Make sure the case is kept dry to protect the system components from humidity.

  • Page 83: Carrying The Itero Element 5D Plus Mobile-Configuration Scanner Within The Clinic

    Element 5D and iTero Element 5D Plus imaging systems User manual Note: If the scanner needs to be lifted, lift it using the upper handle and the post. Figure 47: Moving the scanner To move the cart-configuration scanner while in a seated position: Use the main handle to move the scanner.

  • Page 84: Transporting The Itero Element 5D Plus Mobile-Configuration Scanner Between Clinics

    Element 5D and iTero Element 5D Plus imaging systems User manual 3. Loosely wrap the cable around the cradle for easy and safe portability. Figure 48: Carrying the scanner between rooms within the clinic 4.4.5 Transporting the iTero Element 5D Plus mobile-configuration scanner between clinics When transporting the mobile-configuration scanner between clinics, always pack the scanner in its supplied trolley.

  • Page 85: User Interface

    Element 5D and iTero Element 5D Plus imaging systems User manual User interface The iTero system provides an intuitive user interface for performing digital scans for Restorative or Orthodontic use. The touch screen and wand buttons are used to respond to screen instructions during the scanning process.

  • Page 86: Figure 51: Percentage Of Remaining Battery Charge

    Element 5D and iTero Element 5D Plus imaging systems User manual Tap to view the percentage of remaining charge: Figure 51: Percentage of remaining battery charge Learning Center: Tap to access training materials and educational videos for the iTero scanner.
  • Page 87 Element 5D and iTero Element 5D Plus imaging systems User manual In this view, the button changes to two additional buttons: Tap for remote assistance from Customer Support. Customer Support is available from every Help overlay. Note: Please call Customer Support before trying to connect remotely.

  • Page 88: Scanner Toolbar

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.5.1 Scanner toolbar The following toolbar is displayed on the top of each of the scanner windows: Figure 53: Scanner toolbar The 4 center buttons indicate the current status of the scan process. Tap the buttons to navigate through the scan flow.

  • Page 89: Figure 54: Percentage Of Remaining Battery Charge

    Element 5D and iTero Element 5D Plus imaging systems User manual Tap to view the percentage of the remaining charge: Figure 54: Percentage of remaining battery charge Tap to adjust the scanner preferences, for example, for wand configuration, localization, user settings, and more.

  • Page 90: Touch-Screen Gestures

    Element 5D and iTero Element 5D Plus imaging systems User manual In this view, the button changes to two additional buttons: Tap for remote assistance from Customer Support. Customer Support is available from every Help overlay. Note: Please call Customer Support before trying to connect remotely.

  • Page 91: Defining The Scanner Settings

    Element 5D and iTero Element 5D Plus imaging systems User manual Defining the scanner settings The scanner settings enable you to define your preferences and the settings that are displayed by default when you use the scanner. To define the scanner settings: 1.

  • Page 92: Defining The Computer Settings

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.1 Defining the Computer settings The Computer settings enable you to define the brightness, volume, Wi-Fi, and time- zone settings for the scanner. 4.6.1.1 Defining the default brightness setting...

  • Page 93: Figure 59: List Of Nearby Wi-Fi Networks

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.1.3 Defining the Wi-Fi settings The first time you connect the scanner to the clinic’s Wi-Fi network, you will need to add the password. After that, by default, the scanner will connect automatically. If you want to connect to a different Wi-Fi network, select the new network and enter the relevant password.

  • Page 94: Figure 60: Connecting To The Clinic Wi-Fi Network

    Element 5D and iTero Element 5D Plus imaging systems User manual 3. Enter the network security key (password) in the window that opens and then tap Connect. Figure 60: Connecting to the clinic Wi-Fi network The scanner connects to the Wi-Fi network, and the status changes to Connected.

  • Page 95: Figure 62: Time Zone Settings

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.1.4 Defining the time zone To define the time zone, tap the Time Zone button, select the time zone from the drop-down list, and then to save the changes and return to the Settings window.

  • Page 96: Defining The User Settings

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.2 Defining the User settings The User settings enable each user to define the settings that are displayed by default when the specific user logs in to the scanner.
  • Page 97 Element 5D and iTero Element 5D Plus imaging systems User manual 2. Select the default scanning preferences from the Scan Settings window. Scan setting Scan options Scanning Position Select your position while scanning the patient: Behind the patient In front of the patient...

  • Page 98: Figure 64: Only Scanning Range Is Highlighted

    Element 5D and iTero Element 5D Plus imaging systems User manual Scan setting Scan options Highlight recommended Select this check box to highlight only the scanning range on the scanning range check box navigation controls. Figure 64: Only scanning range is highlighted...

  • Page 99: Figure 65: Rx Settings Window

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.2.2 Defining the Rx settings You can define the settings that are displayed by default when you open the Scan Details window to fill in a new To define the Rx settings: 1.
  • Page 100 Select whether NIRI data should be disabled by default, as described in Disabling NIRI data capture for all scans, below. Note: This section is not relevant for iTero Element 5D Plus Lite systems. 3. Tap to save the changes and return to the Settings window.

  • Page 101: Figure 66: Rx Settings Window - Niri Captures Option Enabled

    4.6.2.3 Disabling NIRI data capture for all scans Note: This section is not relevant for iTero Element 5D Plus Lite systems. When patients are scanned, the NIRI data is captured by default. However, you can disable capturing the NIRI data. In this case, none of the NIRI features will be displayed in the GUI, and NIRI data will not be captured, saved, or sent.

  • Page 102: Figure 68: Rx Settings Window - Niri Captures Option Disabled

    Element 5D and iTero Element 5D Plus imaging systems User manual 3. Tap OK to confirm. Figure 68: Rx Settings window – NIRI Captures option disabled © 2022 Align Technology, Inc. All rights reserved.

  • Page 103: Figure 69: Signature Settings Window

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.2.4 Defining the signature settings You can define the default settings that are displayed when sending an order to the lab. To define the signatures settings: 1. Tap the Signature Settings button.

  • Page 104: Defining The System Settings

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.2.5 Defining the language settings Tap the Language button, select the required language from the drop-down list, and then tap to save the changes and return to the Settings window.

  • Page 105: Figure 71: Login Settings Window

    Element 5D and iTero Element 5D Plus imaging systems User manual To define the period of inactivity: 1. Tap the Login Settings button. The Login Settings window is displayed. Figure 71: Login Settings window 2. Select the period of inactivity after which the user will be logged out of the scanner. (Min time: 10 minutes, Max time: 8 hours) 3.

  • Page 106: Figure 72: Diagnostics Window

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.3.2 Running diagnostics Tap the Diagnostics button to check the network connection and speed. To run system diagnostics: 1. Tap the Diagnostics button. The network connection and speed are checked.

  • Page 107: Figure 73: Licensing Information Window

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.3.3 Licenses Tap the Licenses button to view a list of third-party software components installed on the scanner and then tap to return to the Settings window. Figure 73: Licensing Information window...

  • Page 108: Figure 74: System Information Window - Itero Element 5D Plus

    Element 5D and iTero Element 5D Plus imaging systems User manual 4.6.3.4 System information Tap the System Information button to view details about the software versions currently installed and the hardware serial numbers and ID, and then tap to return to the Settings window.

  • Page 109: Figure 75: Export Settings Window - Deleting Exported Files

    Element 5D and iTero Element 5D Plus imaging systems User manual To edit the export settings: 1. Tap the Export Settings button. 2. Select the number of days after which exported files should be deleted. By default, this is set at 30 days.

  • Page 110: Starting A New Scan

    Element 5D and iTero Element 5D Plus imaging systems User manual Starting a new scan Before starting a new scan, you must: Add a new patient, as described in Adding new patients or search for an existing patient, described in...

  • Page 111: Figure 77: New Scan Window Showing An Empty Rx And The Progress Toolbar At The Top Of The Window

    Figure 77: New Scan window showing an empty Rx and the progress toolbar at the top of the window If you have an iTero Element 5D Plus Lite system, the New Scan window is displayed as follows: Figure 78: New Scan window – iTero Element 5D Plus Lite...

  • Page 112: Patient Management

    Confirming a new wand sleeve between patients. Note: This section is not displayed for iTero Element 5D Plus Lite systems. Notes: Enables you to make specific notes regarding the patient’s treatment. The scanning process requires the following steps, which are displayed on the toolbar:...

  • Page 113: Adding New Patients

    Element 5D and iTero Element 5D Plus imaging systems User manual Clear the patient data from the New Scan window, as described in Clearing the patient details from the New Scan window 5.3.1 Adding new patients You can add a new patient while filling in the Rx or at any time before.

  • Page 114: Figure 80: New Patient Window

    Element 5D and iTero Element 5D Plus imaging systems User manual The New Patient window is displayed. Figure 80: New Patient window 2. Enter the patient’s first name and last name. 3. If required, enter a chart number. 4. Tap Add to add the new patient.

  • Page 115: Figure 81: Adding The New Patient

    Element 5D and iTero Element 5D Plus imaging systems User manual The new patient’s name and chart number, if relevant, are displayed in the New Scan window. Figure 81: Adding the new patient Note: If you try adding a patient who already exists, a message is displayed notifying you that a patient with the same details exists.

  • Page 116: Searching For Existing Patients

    Element 5D and iTero Element 5D Plus imaging systems User manual a. If this is the same person, tap Add. You are prompted to confirm whether the new patient is the same patient as the existing patient. Figure 83: Confirmation message regarding an existing patient b.

  • Page 117: Figure 84: New Scan Window - Searching For An Existing Patient

    Element 5D and iTero Element 5D Plus imaging systems User manual To search for an existing patient: 1. In the Patient area, tap Figure 84: New Scan window – searching for an existing patient © 2022 Align Technology, Inc. All rights reserved.

  • Page 118: Figure 85: Search Patient Window With Search Field

    Element 5D and iTero Element 5D Plus imaging systems User manual The Search Patient window is displayed. Figure 85: Search Patient window with search field 2. In the Search Patient window, enter at least three letters in the search field to display a list of patients matching the search criteria.

  • Page 119: Figure 86: Search Criteria In The Search Field And List Of Matching Patients

    Element 5D and iTero Element 5D Plus imaging systems User manual Figure 86: Search criteria in the search field and list of matching patients 3. Select the required patient, and then tap Select Patient. Figure 87: Selecting the required patient...

  • Page 120: Editing The Patient Details

    Element 5D and iTero Element 5D Plus imaging systems User manual The selected patient is displayed in the New Scan window. Figure 88: Selected patient displayed in the New Scan window 5.3.3 Editing the patient details After you have searched for and selected a patient, or after you have added a new patient, you can edit the patient’s details.

  • Page 121: Figure 89: New Scan Window - Editing A Patient

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. In the Patient area, tap Figure 89: New Scan window – editing a patient The Edit Patient window is displayed. 3. Edit the patient’s details as required and then tap Update.

  • Page 122: Clearing The Patient Details From The New Scan Window

    Element 5D and iTero Element 5D Plus imaging systems User manual If, while editing the patient’s name, you enter the same details as an existing patient, a message is displayed notifying you of such. Figure 91: Message that a patient with the same details already exists To differentiate between patients with the same details, use a chart number.

  • Page 123: Filling In The Rx

    NIRI data in the scan, as well as add notes about the case. Fields marked with a red asterisk are mandatory. Note: NIRI technology is not supported by iTero Element 5D Plus Lite systems. After you have filled in the Rx, tap...

  • Page 124: Figure 93: Selecting The Required Case Type

    Element 5D and iTero Element 5D Plus imaging systems User manual To fill in the Rx: 1. In the Patient area, tap to create a new patient, as described in Adding new patients. to search for an existing patient, as described in Searching for existing patients.

  • Page 125: Figure 94: New Scan Window - Irecord Case Type

    Element 5D and iTero Element 5D Plus imaging systems User manual Vivera: A simple scan with no additional modification, for the creation of a clear retainer that is similar to a single Invisalign aligner, which maintains the position of the teeth after treatment.

  • Page 126: Working With Restorative Scan Types

    Element 5D and iTero Element 5D Plus imaging systems User manual 5. In the Scan Options area, select whether to capture NIRI data in the scan. By default, all images are captured with NIRI data enabled. If required, you can select to disable NIRI data capture. For more information, see Disabling NIRI data capture for all scans.

  • Page 127: Figure 96: New Scan Window - Restorative Case Type With A Tooth Chart

    Element 5D and iTero Element 5D Plus imaging systems User manual To scan a restorative or chairside milling case: 1. From the Case Type drop-down list, select Restorative. A tooth chart is displayed in the window. Figure 96: New Scan window – Restorative case type with a tooth chart 2.

  • Page 128: Figure 97: List Of Restorative Treatment Options

    Element 5D and iTero Element 5D Plus imaging systems User manual 3. In the tooth chart, tap on the tooth to be restored. A list of available treatment options for the selected tooth is displayed. Figure 97: List of restorative treatment options...

  • Page 129: Figure 98: Defining The Restoration Properties

    Element 5D and iTero Element 5D Plus imaging systems User manual 4. Select the required treatment option, for example, Crown. You are prompted to select the settings for the selected treatment option. Figure 98: Defining the restoration properties 5. Select the following settings from the relevant drop-down lists. Settings marked with an asterisk are mandatory.

  • Page 130: Figure 99: Treatment Information Area

    Element 5D and iTero Element 5D Plus imaging systems User manual 6. Tap to save the selection and return to the New Scan window. The selected treatment options are displayed in the Treatment Information area. Figure 99: Treatment Information area You can change the selected treatment options at any time before sending the scan by tapping ©...

  • Page 131: Disabling Niri Capture

    5.4.2 Disabling NIRI capture Note: This section is not relevant for iTero Element 5D Plus Lite systems. When patients are scanned, the NIRI data is captured by default. However, you can disable capturing the NIRI data, before starting a new scan. In this case, none of the NIRI features are displayed in the GUI, and NIRI data is not captured, saved, or sent.

  • Page 132: Figure 101: Scan Tool Without The Option To Display Niri Data In The Viewfinder Or To Enlarge The Viewfinder

    Element 5D and iTero Element 5D Plus imaging systems User manual Figure 101: Scan tool without the option to display NIRI data in the viewfinder or to enlarge the viewfinder Figure 102: Review tool is not displayed in View mode After scanning, you can view the NIRI status of each scan in the Orders page on the scanner and in MyiTero.

  • Page 133: Confirming A New Wand Sleeve Between Patients

    The wand sleeves are intended for single-patient use and must be disposed of and replaced after each patient in order to avoid cross-contamination. Note: The following software steps are not applicable for iTero Element 5D Plus Lite systems. You can confirm the new wand sleeve using one of the following options:...

  • Page 134: Scanning The Patient

    Scan mode. The Scan window is displayed, enabling you to start scanning the patient. The iTero Element 5D scanner provides simultaneous capture and display of NIRI, 2D color images, and 3D intraoral optical impression data.

  • Page 135: Scanning Guidance

    Element 5D and iTero Element 5D Plus imaging systems User manual Toggle between the 3D and the viewfinder display, described in Toggling the 3D and viewfinder display Toggle between displaying a color image or a NIRI image in the viewfinder, as described in...

  • Page 136: Scanning Best Practices

    Element 5D and iTero Element 5D Plus imaging systems User manual In addition, if you press both wand buttons simultaneously, the following guidance is displayed: Figure 106: Wand guidance To allow optimal capturing of the NIR images, the wand should be held 0-3mm above the patient’s teeth.

  • Page 137: Figure 107: Areas With Missing Anatomy Shown With And Without Additional Scan Feedback - Monochrome

    Element 5D and iTero Element 5D Plus imaging systems User manual Edit the scan: Delete a segment, described in Deleting a segment Delete a selection, described in Deleting a selection Fill in missing anatomy, described in Filling in missing anatomy Disable A.I cleanup, described in...

  • Page 138: Figure 109: Model Displayed In Color And Monochrome Mode

    Element 5D and iTero Element 5D Plus imaging systems User manual By default, this mode is enabled, but it can be disabled per case by tapping or by default in the Scan settings, as described in Defining the scan settings.

  • Page 139: Toggling The 3D And Viewfinder Display

    Element 5D and iTero Element 5D Plus imaging systems User manual You can move to the next segment by: Tapping on the relevant arch, prepped tooth, or bite segment Tapping the arrows Figure 110: Tap the opposite arch or tap the arrows to select it Swiping to the left or the right on the wand touchpad.

  • Page 140: Figure 111: Default View - 3D Scan In The Center Of The Window And Viewfinder On The Left

    Element 5D and iTero Element 5D Plus imaging systems User manual Figure 111: Default view – 3D scan in the center of the window and viewfinder on the left To switch to a large viewfinder in the center of the screen, tap the button.

  • Page 141: Toggling Between Color And Niri Images In The Viewfinder

    Toggling between color and NIRI images in the viewfinder Note: This section is not relevant for iTero Element 5D Plus Lite systems. In addition to moving the viewfinder, you can toggle the display to show the viewfinder image either in color or as a NIRI image.

  • Page 142: Viewing The Scan

    Element 5D and iTero Element 5D Plus imaging systems User manual The editing tools are accessed by pressing on the screen. Figure 114: Editing tools Viewing the scan After scanning the patient, tap to move to View mode to inspect the model in high resolution to ensure that sufficient occlusal and buccal anatomy have been captured, and that the model is accurate and complete.

  • Page 143: Missing Scan Segment Notifications

    Element 5D and iTero Element 5D Plus imaging systems User manual After you have reviewed the scan, tap on the toolbar to send the scan to the lab or to storage, as described Sending the scan. 5.6.1 Missing scan segment notifications...

  • Page 144: Using The Scan Timer

    Element 5D and iTero Element 5D Plus imaging systems User manual You can tap Return to Scanning to go back to Scan mode and rescan the missing segments, which are highlighted in red in the navigation controls. 5.6.2 Using the scan timer The scan timer enables you to see how long it took to scan the model.

  • Page 145: Working With The Viewer

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. Add your signature to authorize the order and then tap Confirm and Send. Figure 117: Sending the scan 3. If required, select the Save Signature check box to save your signature for authorizing future cases.

  • Page 146: Figure 119: Viewer Option In Patient's Profile Page

    Element 5D and iTero Element 5D Plus imaging systems User manual Figure 119: Viewer option in patient’s profile page Note: The NIRI column in the Orders page and the patient's profile page is not displayed for iTero Element 5D Plus Lite systems.

  • Page 147: Figure 120: Model In A 1-Window View

    Element 5D and iTero Element 5D Plus imaging systems User manual Display the model in a 1-window view, with the upper and lower jaws in the same window (Frontal view). Figure 120: Model in a 1-window view Relevant for Orthodontic case types only.

  • Page 148: Figure 121: Model In A 2-Window View

    Element 5D and iTero Element 5D Plus imaging systems User manual Display the model in a 2-window view, with the upper and lower jaws in separate windows (Occlusal view). Each model can be controlled separately, for better evaluation. Figure 121: Model in a 2-window view Relevant for Orthodontic case types only.

  • Page 149: Removing The Wand Sleeve

    Element 5D and iTero Element 5D Plus imaging systems User manual Display/hide the margin line of the prepped tooth. Relevant for Restorative case types only. Show/hide the ditch created by the Modeling team. This will be enabled in the Viewer only after the modeling phase.

  • Page 150: Figure 124: Optical Surface Of The Wand

    Element 5D and iTero Element 5D Plus imaging systems User manual CAUTION: Dispose of used sleeves according to standard operating procedures or local regulations for the disposal of contaminated medical waste. CAUTION: OPTICAL SURFACE! DO NOT touch the optical surface of the wand. Contact may cause damage. If additional cleaning, besides that...

  • Page 151: Working With Patients

    Element 5D and iTero Element 5D Plus imaging systems User manual Working with patients On the home screen, tap the Patients button to display the Patients page. The Patients page displays a list of all your patients, their chart number, and the date of their last scan, if relevant.

  • Page 152: Figure 127: Searching For A Patient

    Element 5D and iTero Element 5D Plus imaging systems User manual To search for a patient: In the Patients page, enter the patient’s name or chart number (or part thereof) in the search field and then tap the search button Figure 127: Searching for a patient The patients that match the search criteria are displayed.

  • Page 153: Viewing The Patient Details

    The selected patient’s profile page is displayed: Figure 129: Patient’s profile page Note: The NIRI column is not displayed for iTero Element 5D Plus Lite systems. From the patient’s profile page, you can: Create a new scan for the specific patient, described in...

  • Page 154: Creating A New Scan For A Specific Patient

    1. In the patient’s profile page, tap New Scan. Figure 130: Patient’s profile page – New Scan option Note: The NIRI column is not displayed for iTero Element 5D Plus Lite systems. © 2022 Align Technology, Inc. All rights reserved.

  • Page 155: Figure 131: New Scan Window With Patient's Details Already Filled In

    Element 5D and iTero Element 5D Plus imaging systems User manual The New Scan window is displayed, with the patients details already filled in. Figure 131: New Scan window with patient’s details already filled in 2. Fill in the rest of the Rx details according to the new requirements.

  • Page 156: Viewing The Rx

    1. In the patient’s profile page, select the order for which to view the Rx and then tap View Rx. Figure 132: Patient’s profile page – View Rx option Note: The NIRI column is not displayed for iTero Element 5D Plus Lite systems. © 2022 Align Technology, Inc. All rights reserved.

  • Page 157: Viewing Previous Scans In The Viewer

    Element 5D and iTero Element 5D Plus imaging systems User manual The Rx Details window is displayed. Figure 133: Rx Details window 2. Tap to return to the patient’s profile page. Viewing previous scans in the Viewer If required, you can display previous scans in the Viewer.

  • Page 158: Figure 134: Patient's Profile Page - Viewer Option

    Element 5D and iTero Element 5D Plus imaging systems User manual To view a previous scan in the Viewer: 1. In the patient’s profile page, tap the scan you want to display in the Viewer and then tap Viewer.

  • Page 159: Working With Orders

    You can view the following details for each order: the patient’s name, chart number, the scan date, case type, whether NIRI data was captured, and the status of the order. Note: The NIRI column is not displayed for iTero Element 5D Plus Lite systems. The order could have one of the following statuses, depending on the case type: Rx Created: The Rx has been filled in, but the patient has not been scanned yet.

  • Page 160: Figure 136: Orders Page

    Element 5D and iTero Element 5D Plus imaging systems User manual Figure 136: Orders page To view or review orders: 1. Tap the Orders button on the home screen. The Orders page is displayed, showing two panes – In Progress orders and Past Orders.

  • Page 161: Figure 137: In Progress Pane - Options

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. Tap on an order in the In Progress pane to view the following options: Figure 137: In Progress pane – options View Rx: Opens the Rx Details window, enabling you to view the prescription for this order.

  • Page 162: Working With Returned Orders

    Element 5D and iTero Element 5D Plus imaging systems User manual View Rx: Opens the Rx Details window, enabling you to view the prescription for this order. Viewer: Opens the Viewer window, enabling you to view and manipulate the model. For more information...

  • Page 163: Figure 140: Returned Order In The In Progress Pane

    Element 5D and iTero Element 5D Plus imaging systems User manual The returned order is displayed at the top of the In Progress pane, with the status Returned, in red. Figure 140: Returned order in the In Progress pane To fix a returned case: 1.

  • Page 164: Viewing Messages

    Element 5D and iTero Element 5D Plus imaging systems User manual Viewing messages The Messages page displays notifications, updates, and other system messages from Align Technology, for example, product updates, upcoming educational sessions, or internet connectivity issues. If relevant, you can view the number of new or unread messages on the badge on the Messages button.

  • Page 165: Working With Myitero

    Element 5D and iTero Element 5D Plus imaging systems User manual Working with MyiTero MyiTero is a web-based portal, with the same look-and-feel as the iTero software. It enables users to carry out administrative tasks such as filling in a new Rx on any supported device, for example, a PC or a tablet, without using valuable scanner time.

  • Page 166: 10 Itero Scanner Features And Tools

    Element 5D and iTero Element 5D Plus imaging systems User manual 10 iTero scanner features and tools This section describes the following iTero scanner features and tools: Comparing previous scans using iTero TimeLapse technology Invisalign Go system Invisalign Outcome Simulator...

  • Page 167: Figure 142: Itero Timelapse - Selecting The Scans To Compare

    Figure 142: iTero TimeLapse – selecting the scans to compare Note: The NIRI column is not displayed for iTero Element 5D Plus Lite systems. 3. Tap the Compare Selected button to compare and analyze the scans. The iTero TimeLapse window is displayed, highlighting the areas with changes between the scans. The darker the color, the bigger the change between the scans, as displayed in the legend.

  • Page 168: Figure 144: Area Of Interest From The First Scan Displayed In The Animation Window

    Element 5D and iTero Element 5D Plus imaging systems User manual Note: Changes are highlighted only when the scans are displayed in monochrome mode. If required, tap to move the scan to the default occlusal view – lower arch with anterior teeth at the bottom and upper arch with anterior teeth at the top and both arches in a frontal view like the iRecord default view.

  • Page 169: Figure 145: Area Of Interest From The Second Scan Displayed In The Animation Window

    Element 5D and iTero Element 5D Plus imaging systems User manual Figure 145: Area of interest from the second scan displayed in the animation window You can zoom in to the image in the animation window or tap the pause button to pause the animation.

  • Page 170: 10.2 Invisalign Go System

    Element 5D and iTero Element 5D Plus imaging systems User manual a. On the legend, tap Scale. The legend is expanded to display a list of ranges: Figure 146: iTero TimeLapse scale options b. Select the required scale. The changes are displayed according to the new scale.

  • Page 171: 10.4 Invisalign Progress Assessment

    Element 5D and iTero Element 5D Plus imaging systems User manual You can make real-time adjustments to the simulated outcome while showing the patient. This tool provides additional information for the patient in their decision to accept treatment. To open the Invisalign Outcome Simulator tool, after sending the scan, tap Invisalign Outcome Simulator in the...

  • Page 172: 10.5 Editing Tools

    Element 5D and iTero Element 5D Plus imaging systems User manual 10.5 Editing tools After you have scanned the model, you can edit it using the following tools: Delete Segment tool, described in Deleting a segment Delete Selection tool, described in...

  • Page 173: Figure 149: Delete Segment Tool

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. Tap the Delete Segment tool Figure 149: Delete Segment tool A confirmation message is displayed. 3. Tap OK to confirm the deletion. The entire scanned segment is deleted.

  • Page 174: 10.5.2 Deleting A Selection

    Element 5D and iTero Element 5D Plus imaging systems User manual 10.5.2 Deleting a selection The Delete Selection tool enables you to delete a section of the scan so that it can be rescanned. To delete a selection: 1. Press the screen to display the editing tools.

  • Page 175: Figure 151: Expanded Delete Selection Tool

    Element 5D and iTero Element 5D Plus imaging systems User manual The Delete Selection tool expands, and the model is displayed in monochrome. Figure 151: Expanded Delete Selection tool 3. Touch the area of the anatomy you want to delete.

  • Page 176: 10.5.3 Filling In Missing Anatomy

    Element 5D and iTero Element 5D Plus imaging systems User manual 4. If required, tap to undo the changes. 5. Tap to rescan the deleted anatomy. 10.5.3 Filling in missing anatomy Occasionally there are areas with missing anatomy that are not filled even after trying to scan the area numerous times.

  • Page 177: 10.5.4 Disabling A.i. Cleanup

    Element 5D and iTero Element 5D Plus imaging systems User manual Areas that require scanning are highlighted in red. Figure 154: Areas that require scanning are highlighted in red – Fill tool 3. Rescan the patient. In order to prevent over scanning, only the highlighted areas are scanned, and the voids are filled.

  • Page 178: Figure 155: Disable A.i. Cleanup Tool

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. Tap the Disable A.I. Cleanup tool. Figure 155: Disable A.I. Cleanup tool The scan is displayed with the excess material showing. Figure 156: Scan displayed with excess material showing 3.

  • Page 179: 10.6 Working With The Eraser Tool

    Element 5D and iTero Element 5D Plus imaging systems User manual 10.6 Working with the Eraser tool The Eraser tool enables you to erase a selected area of the scanned model and then rescan only the erased area. For example: You can remove moisture and artifacts, such as blood or saliva, that are covering the margin.

  • Page 180: Figure 159: Mark The Area To Be Modified

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. With your finger, mark the area to be modified. Figure 159: Mark the area to be modified As soon as you lift your finger, the selected area is removed and the scan tool is enabled.

  • Page 181: 10.7 Working With The Occlusal Clearance Tool

    Element 5D and iTero Element 5D Plus imaging systems User manual 3. If required, tap to undo the deletion. 4. After adjusting the clearance on the patient’s tooth, tap to return to Scan mode and rescan the deleted area, which is marked in red.

  • Page 182: Figure 162: Occlusal Clearance Between The Opposing Teeth

    Element 5D and iTero Element 5D Plus imaging systems User manual To display the occlusal clearance while in View mode: 1. In the View window, tap the Occlusal Clearance tool The occlusal clearance between the opposing teeth is displayed.

  • Page 183: Figure 163: Occlusal Clearance Range Options

    Element 5D and iTero Element 5D Plus imaging systems User manual a. On the legend, tap Scale. The legend is expanded to display a list of range options. Figure 163: Occlusal Clearance range options b. Select the required scale.

  • Page 184: Figure 164: Occlusal Clearance Tool And Legend Displayed In The Viewer

    Element 5D and iTero Element 5D Plus imaging systems User manual The clearance between the opposing teeth is displayed, as well as a legend displaying the scale. Figure 164: Occlusal Clearance tool and legend displayed in the Viewer 3. If required, tap to take a screenshot of the occlusal clearance.

  • Page 185: 10.8 Working With The Edge Trimming Tool

    Element 5D and iTero Element 5D Plus imaging systems User manual 10.8 Working with the Edge Trimming tool The Edge Trimming tool enables you to trim away excess soft tissue such as cheek or lip artifacts from the scan. This tool is available for all case types, except Restorative case types.

  • Page 186: Figure 167: Mark The Area To Be Trimmed Away

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. With your finger, mark the area you would like to trim away. Figure 167: Mark the area to be trimmed away The area to be trimmed away is highlighted and the confirmation icon is enabled.

  • Page 187: 10.9 Working With The Die Separation Tool

    Element 5D and iTero Element 5D Plus imaging systems User manual 3. If required, you can tap to undo the trimming. 4. Tap to confirm the trimming. The selected area is removed. Figure 169: Selected area has been removed 10.9 Working with the Die Separation tool...

  • Page 188: Figure 170: Green Hint Point Centered On The Prepped Tooth

    Element 5D and iTero Element 5D Plus imaging systems User manual Figure 170: Green hint point centered on the prepped tooth 2. Tap on the toolbar to move to View mode. 3. In the View window, tap the Die Separation tool The die separation is displayed in high resolution.

  • Page 189: Figure 172: Die Separation Tool Options

    Element 5D and iTero Element 5D Plus imaging systems User manual To create the die separation manually: 1. In the View window, tap the Die Separation tool The tool expands to show the following options: Figure 172: Die Separation tool options 2.

  • Page 190: Figure 174: Before Selecting The Die Separation

    Element 5D and iTero Element 5D Plus imaging systems User manual 3. Tap to mark the prepped tooth in high resolution. The model is displayed as follows: Figure 174: Before selecting the die separation © 2022 Align Technology, Inc. All rights reserved.

  • Page 191: 10.10 Working With The Margin Line Tool

    Element 5D and iTero Element 5D Plus imaging systems User manual 4. Draw the area for the die separation. The selected area is displayed in high resolution. Figure 175: Prepped tooth is displayed in high resolution 10.10 Working with the Margin Line tool...

  • Page 192: Figure 176: Model Display Moves To The Occlusal View, And Zooms In On The Prepped Tooth

    Element 5D and iTero Element 5D Plus imaging systems User manual To define the margin line automatically: 1. In the View window, tap the prepped tooth in the navigation controls. The 3D model display moves to the occlusal view and zooms in on the prepped tooth.

  • Page 193: Manually Defining The Margin Line

    Element 5D and iTero Element 5D Plus imaging systems User manual A message is displayed prompting you to wait while the automatic AI-based margin line is being detected. After a few seconds, the margin line is automatically marked on the prepped tooth. The teeth adjacent to the prepped tooth appear transparent, enabling you to see the edges of the margin line.

  • Page 194: Working With The Review Tool (Itero Element 5D And 5D Plus)

    10.11 Working with the Review tool (iTero Element 5D and 5D Plus) Note: This section is for iTero Element 5D and 5D Plus systems only. If you have an iTero Element 5D Plus Lite system, please see Working with the Review tool (iTero Element 5D Plus Lite).

  • Page 195: Figure 180: Review Tool With The Snapshot Tool On The Toolbar And The Loupe In The Right Pane

    Element 5D and iTero Element 5D Plus imaging systems User manual To activate the Review tool: In the View window, tap and then drag the loupe from the right pane over an area of interest. Figure 180: Review tool with the Snapshot tool on the toolbar and the loupe in the right pane The area within the loupe is displayed in the image pane on the right.

  • Page 196: Zooming In To And Out Of The Images In The Image Pane

    Element 5D and iTero Element 5D Plus imaging systems User manual A NIRI and colored intraoral image are displayed one below the other in the image pane on the right. The NIRI and colored intraoral images in the image pane match the direction of the loupe and are updated simultaneously while moving the loupe over the 3D display.

  • Page 197: Figure 182: Zoom-In Buttons On The Images In The Image Pane

    Element 5D and iTero Element 5D Plus imaging systems User manual To zoom in or out using the zoom button: 1. Tap on either the NIRI or the colored intraoral image to zoom in to that view. Figure 182: Zoom-in buttons on the images in the image pane The image in the image pane is enlarged and only the specific image is displayed.

  • Page 198: Adjusting The Brightness And Contrast Of Images In The Image Pane

    Element 5D and iTero Element 5D Plus imaging systems User manual 10.11.2Adjusting the brightness and contrast of images in the image pane You can set the brightness and contrast of each of the images displayed in the image pane by adjusting the relevant sliders in the brightness and contrast toolbar.

  • Page 199: Capturing The Review Tool Images

    Element 5D and iTero Element 5D Plus imaging systems User manual A brightness and contrast adjustment toolbar is displayed on each of the windows in the image pane. By default, the brightness level is set to the lowest position and the contrast is set to the middle position.

  • Page 200: Figure 186: Review Tool With The Snapshot Tool On The Toolbar And The Loupe In The Right Pane

    Element 5D and iTero Element 5D Plus imaging systems User manual contrast of images in the image pane Capture screenshots of the image, as described in Working with the Snapshot tool To activate the Review tool: In the View window, tap and then drag the loupe from the right pane over an area of interest.

  • Page 201: Zooming In To And Out Of The Images In The Image Pane

    Element 5D and iTero Element 5D Plus imaging systems User manual The area within the loupe is displayed in the image pane on the right. The display in the image pane changes according to the position of the loupe.

  • Page 202: Figure 188: Zoom-In Button On The Image In The Image Pane

    Element 5D and iTero Element 5D Plus imaging systems User manual To zoom in or out using the zoom button: 1. Tap on the colored intraoral image to zoom in to the area of interest. Figure 188: Zoom-in button on the image in the image pane The image pane is enlarged to display the zoomed-in image.

  • Page 203: Adjusting The Brightness And Contrast Of Images In The Image Pane

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. Tap on the enlarged 2D image to return the image to the default size. 10.12.2Adjusting the brightness and contrast of images in the image pane You can set the brightness and contrast of the images displayed in the image pane by adjusting the relevant sliders in the brightness and contrast toolbar.

  • Page 204: Capturing The Review Tool Images

    Element 5D and iTero Element 5D Plus imaging systems User manual A brightness and contrast adjustment toolbar is displayed on window in the image pane. By default, the brightness level is set to the lowest position and the contrast is set to the middle position.

  • Page 205: 10.13 Working With The Snapshot Tool

    If you are taking screenshots while using the Review tool, the following screenshots are included: Entire Review tool window, including 3D image, and 2D NIRI and color viewfinder images Note: The 2D NIRI image is not displayed for iTero Element 5D Plus Lite systems. 3D image...

  • Page 206: Figure 192: View Mode - With Snapshot Tool

    Element 5D and iTero Element 5D Plus imaging systems User manual To capture a screenshot of a scanned image: 1. In View mode, tap the Snapshot tool  on the toolbar. Figure 192: View mode – with Snapshot tool The screen flashes, indicating that the screenshot was captured. A thumbnail of the screenshot is displayed on the bottom left of the window and remains for 7 seconds.

  • Page 207: Figure 194: Screenshot With An Annotations Toolbar

    Element 5D and iTero Element 5D Plus imaging systems User manual 2. Tap the thumbnail if you would like to add annotations to the screenshot. The Draw window is displayed, showing a screenshot of the entire window, with an annotations toolbar on the top.

  • Page 208: Figure 196: Adding Text To The Screenshot

    Element 5D and iTero Element 5D Plus imaging systems User manual Note: If you do not tap after entering text, the color of the text will be changed if you select a different color for the next annotation. Figure 196: Adding text to the screenshot 4.

  • Page 209: Figure 198: Notification That The Screenshots And Annotations Will Be Uploaded To Myitero

    Element 5D and iTero Element 5D Plus imaging systems User manual A pop-up message is displayed at the bottom of the screen, notifying that the screenshots and annotations will be uploaded to MyiTero, where you can access them. Figure 198: Notification that the screenshots and annotations will be uploaded to MyiTero 5.

  • Page 210: Figure 200: Notification That The Screenshots Will Be Uploaded To Myitero

    The screenshots can now be downloaded from MyiTero, from the Orders page or the Viewer. Figure 201: Option to download screenshots from the Orders page in MyiTero Note: The NIRI column is not displayed for iTero Element 5D Plus Lite systems. © 2022 Align Technology, Inc. All rights reserved.

  • Page 211: 11 Care And Maintenance

    Element 5D and iTero Element 5D Plus imaging systems User manual 11 Care and maintenance If you are performing any sanitation procedures in the office that involve fogging or spraying, make sure that the iTero scanner is not in the room.

  • Page 212: 11.2.1 Preparation Before Cleaning And Disinfection

    Element 5D and iTero Element 5D Plus imaging systems User manual 11.2.1 Preparation before cleaning and disinfection 1. To avoid false activation of the wand during the cleaning and disinfection procedures, make sure to exit a scan completely by sending the case or by going back to the home screen.

  • Page 213: 11.2.2 Wand Cleaning And Disinfection

    Element 5D and iTero Element 5D Plus imaging systems User manual 11.2.2 Wand cleaning and disinfection Before cleaning and disinfecting the wand, ensure that the sleeve has been removed. Cleaning 1. Using CaviWipes1, remove any gross contaminants on the wand body and wand tip for a minimum of one (1) minute.

  • Page 214: 11.2.3 Drying - Wand Body

    Element 5D and iTero Element 5D Plus imaging systems User manual Disinfection 1. Using CaviWipes1, thoroughly dampen all external surfaces of the wand body and wand tip, including the optical surface and ensure they remain wet for a minimum of one (1) minute.

  • Page 215: 11.3 Cleaning And Disinfecting The Cradle

    Element 5D and iTero Element 5D Plus imaging systems User manual 11.3 Cleaning and disinfecting the cradle The wand cradle requires the procedures in the following sections for cleaning and disinfection. These procedures must be carried out: After the scanner assembly, before first-time use...

  • Page 216: 11.3.2 Cradle Cleaning And Disinfection

    Figure 206: iTero Element 5D – Remove gross contaminants on the cradle using CaviWipes1 Figure 207: iTero Element 5D Plus cart – Remove gross contaminants on the cradle using CaviWipes1 © 2022 Align Technology, Inc. All rights reserved.
  • Page 217 2. Using the soft bristle brush, remove any remaining marks and stains on the cradle, paying special attention to the grooves, indents, joints, etc. Figure 209: iTero Element 5D – Remove remaining marks and stains on the cradle using the soft bristle brush © 2022 Align Technology, Inc. All rights reserved.

  • Page 218: 11.3.3 Drying - Cradle

    Element 5D and iTero Element 5D Plus imaging systems User manual Figure 210: iTero Element 5D Plus cart – Remove remaining marks and stains on the cradle using the soft bristle brush Figure 211: iTero Element 5D Plus mobile – Remove remaining marks and stains on the cradle using the soft bristle brush 3.

  • Page 219: 11.3.4 Storage And Maintenance

    Element 5D and iTero Element 5D Plus imaging systems User manual 11.3.4 Storage and maintenance Visually inspect the cradle for any noticeable damage, for example, deterioration such as discoloration, pitting, or cracks. Warning: Do not use the cradle if any damage is detected. Please contact iTero Customer Support for further instructions.

  • Page 220: 11.6 Approved Cleaning And Disinfecting Materials

    Element 5D and iTero Element 5D Plus imaging systems User manual 11.6 Approved cleaning and disinfecting materials The following table lists the Align-recommended cleaning and disinfecting materials, as well as the minimum contact time required. If you are using liquid disinfectant, soak a clean, sterile, lint-free wipe in the liquid and squeeze until moist, and then follow the cleaning and disinfection instructions described in this document.

  • Page 221: A Clinic Lan Network Guidelines

    Element 5D and iTero Element 5D Plus imaging systems User manual A Clinic LAN network guidelines Introduction The scanner is capable of connecting to the wireless LAN in order to support the file transfer to and from the iTero cloud.

  • Page 222: Router Guidelines

    Element 5D and iTero Element 5D Plus imaging systems User manual Router guidelines Minimum standards: 802.11N / 802.11AC Internet connection guidelines In order to achieve the best performance of your iTero scanner, ensure that the internet connection upload speed is at least 1Mbps per scanner.

  • Page 223: Align Hostname Recommendations

    Element 5D and iTero Element 5D Plus imaging systems User manual Align hostname recommendations Align constantly improves its products and services, and can therefore commit to a Hostname, rather than a specific IP address. The following list of hostnames was created to provide Align’s scanners the proper operation functions, in order to be able to utilize all the advanced capabilities of the scanner performance.

  • Page 224: Bemc Declarations

    Professional Healthcare and Home Healthcare Facility Environment The iTero Element 5D imaging system essential performances are: Display near-infrared imaging without interference on the iTero Element 5D touch screen as part of the caries- detection solution. Stored scan data is accessible and can be displayed.
  • Page 225 Element 5D and iTero Element 5D Plus imaging systems User manual Test Standard Class / Severity level Test results Voltage changes, Voltage IEC 61000-3-3 230 VAC mains @ 50 Hz Complies fluctuations and Flicker test & 220 VAC mains @ 50 Hz...
  • Page 226 Element 5D and iTero Element 5D Plus imaging systems User manual Test Standard Class / Severity level Test results Emission (per ETSI EN 301 489-1, ETSI EN 301 489-17) (relevant for wheel-stand configurations only) Conducted emissions on ETSI EN 301 489-1;...

  • Page 227: Emc Declaration - Itero Element 5D Plus

    Professional Healthcare and Home Healthcare Facility Environment The iTero Element 5D Plus imaging system essential performances are: Display near-infrared imaging without interference on the iTero Element 5D Plus touch screen as part of the caries-detection solution. Stored scan data is accessible and can be displayed.
  • Page 228 Element 5D and iTero Element 5D Plus imaging systems User manual Test Standard Class / Severity level Test results Immunity from Electrostatic IEC 61000-4-2 / 8 kV contact discharges & 15 kV air Complies discharge (ESD) EN 61000-4-2 discharges (AC mode (230 V @ 50 Hz &...
  • Page 229 Element 5D and iTero Element 5D Plus imaging systems User manual Test Standard Class / Severity level Test results Radiated emissions ETSI EN 301 489-1; Class B Complies in freq. range 30 - 6000 MHz ETSI EN 301 489-17 /...

  • Page 230: C Itero Element Product Security Whitepaper

    We identify security risks using robust risk management processes. Align Technology is committed to addressing and minimizing security and privacy risks in the products that we design, develop, and maintain. We conduct in-depth assessments of our products so that we can implement appropriate risk mitigation measures at the outset of product development.
  • Page 231 Applicable to iTero Element, iTero Element 2, iTero Element 5D, iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus Lite Remote maintenance is not possible without permission: The devices use TeamViewer for establishing a remote session.
  • Page 232 Applicable to iTero Element, iTero Element 2, iTero Element Flex, iTero Element 5D, and iTero Element 5D Laptop Configuration, iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus Lite Securely operate and protect your network: It is the customer’s responsibility to secure your network...

  • Page 233: D System Specifications

    Element 5D and iTero Element 5D Plus imaging systems User manual D System specifications This section includes the specifications for the following systems: iTero Element 5D wheel-stand configuration system specifications iTero Element 5D laptop configuration system specifications iTero Element 5D Plus system specifications...

  • Page 234: Itero Element 5D Wheel-Stand Configuration System Specifications

    Element 5D and iTero Element 5D Plus imaging systems User manual iTero Element 5D wheel-stand configuration system specifications Monitor 21.5” Full HD (1920x1080) touch screen The wand emits red laser light (680nm Class 1), as well as white LED Wand emissions and 850nm LED emissions.

  • Page 235: Itero Element 5D Laptop Configuration System Specifications

    Element 5D and iTero Element 5D Plus imaging systems User manual iTero Element 5D laptop configuration system specifications Monitor Laptop screen The wand emits red laser light (680nm Class 1), as well as white LED emissions Wand and 850nm LED emissions.

  • Page 236: Itero Element 5D Plus System Specifications

    Element 5D and iTero Element 5D Plus imaging systems User manual iTero Element 5D Plus system specifications Monitor Cart configuration: 21.5” Full HD (1920x1080) touch screen Mobile configuration: 15.6" Full HD (1920x1080) touch screen The wand emits red laser light (680nm Class 1), as well as white LED Wand emissions and 850nm LED emissions.
  • Page 237 Element 5D and iTero Element 5D Plus imaging systems User manual Physical properties Dimensions Wand: Length: 346 mm (13.3 in) Width: 50 mm (~2.0 in) Depth: 68 mm (~2.7 in) Cart configuration: Wheel stand: Height: 1279 mm (~50.3 in) Width: 544 mm (~21.4 in)
  • Page 238 Element 5D and iTero Element 5D Plus imaging systems User manual Battery Integrated battery for uninterrupted scanning and ease in office portability without plugging in or rebooting, providing: At least 30 minutes of active continuous scanning (cart configuration) and 10 minutes (mobile configuration) <2.5 hours for full recharge...
  • Page 239 Element 5D and iTero Element 5D Plus imaging systems User manual Index Color toggle 110 Comparing scans 138 Compliance ii, viii Computer settings 64 Adding patients 85 Confirming new sleeve 105-106 Additional scan feedback 109 Contraindications ii, viii Assembling the scanner 25...
  • Page 240 Element 5D and iTero Element 5D Plus imaging systems User manual Licenses 79 Logging in 45 Guidance 107 First time 33 Logging out 52 Login settings 76 Hardware 3 Cart configuration 6 Laptop configuration 5 Maintenance 183 Mobile configuration 7...
  • Page 241 Element 5D and iTero Element 5D Plus imaging systems User manual Rx settings 71 Password Resetting 49 Safety instructions v, xi Password policy 50 Scan Patient management 84 Sending 116 Patients 123 Starting 82 Adding 85 Timing 116 Clearing details 94...
  • Page 242 Element 5D and iTero Element 5D Plus imaging systems User manual Licenses 79 TimeLapse technology 138 Login 76 Toolbar 60 Rx 71 Tools Scan 68 Delete Segment 144 Signature 75 Delete Selection 146 Sync configuration 80 Die Separation 159 System 76 Disable A.I Cleanup 149...
  • Page 243 Element 5D and iTero Element 5D Plus imaging systems User manual Wand 8 Handling 183 Wheel stand configuration 4 Whitepaper 202 Wi-Fi settings 65 Wi-Fi tips 194 Zooming in and out of images 168 Zooming in and out of images 173...
  • Page 244 Element 5D and iTero Element 5D Plus imaging systems User manual © 2022Align Technology, Inc. All rights reserved.
  • Page 246 ©2022 Align Technology, Inc. All rights reserved. Align, Invisalign, iTero Element, among others, 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. 215411 Rev. A...

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