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Shining 3D Aoralscan 3 Wireless Manual

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Aoralscan 3 Wireless
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V2.0

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  • Page 1 Aoralscan 3 Wireless Manual V2.0...

  • Page 2: Safety Instructions

    Foreword General The manual (hereinafter referred to as "the Manual") introduces the functions, installation, usage and maintenance of the Aoralscan 3 Wireless (hereinafter referred to as "the Scanner"). Safety Instructions Signal Meaning Additional information for particular situation. Improper actions or conditions that may damage the product or cause injury, and consequently void your warranty or service contract or lose the patient data or system data.
  • Page 3 Shining3D Corporation to notify any person of such revision or changes. ⚫ Updates to hardware and/or software components are made regularly; therefore, some of the instructions, illustrations, and specifications mentioned in the Manual may differ slightly from your particular situation. _V2.0 Aoralscan 3 Wireless_Manual...

  • Page 4: Table Of Contents

    Catalog Foreword ........................1 Read This First ....................- 1 - 1.1. Basic Information ................. - 1 - 1.2. Intended Use ..................- 5 - 1.3. Contraindications ................- 6 - 1.4. Warnings..................... - 6 - 1.5. Waste Electrical and Electronic Equipment ..........- 7 - 1.6.
  • Page 5 4.1. Connect the Scanner ................- 32 - 4.2. Calibrate the Scanner ................. - 37 - 4.3. Disconnect the Scanner ..............- 39 - Scanning Preparations ..................- 41 - 5.1. Intraoral Environment ................ - 41 - 5.2. Scanner Preparation ................- 41 - 5.3.
  • Page 6 7.3.1. Cleaning and High-level Disinfection ..........- 59 - 7.3.2. Cleaning and Steam Sterilization ..........- 61 - 7.3.3. Attach the Scanner Tip ..............- 63 - 7.4. Scanner Storage................. - 64 - 7.4.1. Storage for Transport..............- 64 - 7.4.2.

  • Page 7: Read This First

    1. Read This First Aoralscan 3 Wireless is an intraoral scanner that works with the supplied software programs. By performing intraoral scanning directly and digitally acquiring and saving the 2D/3D color images of teeth and gingiva, the Scanner is available for patients with needs of orthodontic, implant, and restoration.
  • Page 8 Email: peter@lotusnl.com EU Importer Shining3D Technology GmbH Address: Breitwiesenstraße 28, 70565 Stuttgart Germany Telephone: +49-711-28444089 Product performance - Appearance and structure The appearance should be: Smooth, no cracks, no stains, no obvious deformation. Flexible and reliable for operation. - Function control and display Function control: After pressing the scanning button, determine whether the front end of the scanner flashes normally.
  • Page 9 The software displays the device temperature in real time. When the device is too hot, please stop using it and put it back to the cradle. The camera window automatically adopts the scanner types. -User Access Control Normal user access control. Users can log in via their login name and password. -Performance Dental scan imaging: The scanner scans the teeth, gingiva or a teeth model to form a 3D digital model and the users can check the 2D and 3D imaging of the scanned object (such as...
  • Page 10 operating conditions. 1) Do not connect the scanner to power if not used, keep it in dry environment. 2) Use dust cap when you leave the scanner unworking. 3) After using scanner tip, use alcohol to wipe and then use autoclave to sterilize it. (121°C, 102.9kPa for 30 minutes;...

  • Page 11: Intended Use

    Caution ⚫ The Aoralscan 3 Wireless intraoral scanner should not be used in close proximity or stacked with other equipment, and if it must be used in close proximity or stacked, observe to verify proper operation in the configuration in which it is used.

  • Page 12: Contraindications

    1.3. No known contraindications (or side effects). Warnings 1.4. Before using the Aoralscan 3 Wireless, read warnings and Safety information on chapter 2. ⚫ Do not attempt to disassemble, repair, or modify the scanner and software. Aoralscan 3 Wireless_ Manual...

  • Page 13: Waste Electrical And Electronic Equipment

    ⚫ There are no user serviceable parts inside the scanner. Necessary modifications must be made only by the manufacturer or its designated agents. ⚫ Do not allow foreign objects (including all types of liquids) to enter the scanner and its cradle.

  • Page 14: Disposal

    Warranty 1.7. The warranty is void if unauthorized personnel perform service or maintenance on the set of Aoralscan 3 Wireless. To ensure correct product performance and to obtain warranty service, contact technical support. Aoralscan 3 Wireless_ Manual _V2.0...

  • Page 15: Safety Information

    ⚫ To ensure the performance and safety of the scanner, use only the original accessories provided with the scanner (or accessories specified by Shining 3D, consult technical support for details) and software. ⚫ Use only supplied accessories and approved software with the scanner in order to achieve the designed performance.

  • Page 16: Labels And Symbols

    to fire or explosion. ⚫ Using cables or accessories other than those specified for use with the scanner might result in increased emissions or decreased immunity of the device. ⚫ The supplied medical grade power adapter should only be connected to a grounded power socket.
  • Page 17 Symbol Explanation To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. Indicate that the contents of the transport package are fragile and the package shall be handled with care.

  • Page 18: Compliance

    Type BF applied part. To identify a type BF applied part complying with IEC 60601-1. Class 1 laser product. Signify that the instruction manual/booklet must be read. Indicates the need for the user to consult the instructions for use. Indicate the unique device identifier information. Indicate the entity importing the medical device into the locale.

  • Page 19: Electrical Safety

    ⚫ The grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. Such modifications could void the user’s authority to operate the equipment. ⚫ This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.

  • Page 20: Classification

    disturbances– Requirements and tests ⚫ IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability ⚫ IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 Medical electrical equipment–Part 1-9: General requirements for basic safety and essential performance–Collateral Standard: Requirements for environmentally conscious design ⚫...

  • Page 21: Emc Notice

    The guidance and manufacturer's statement are shown in the attached table. Warning ⚫ Aoralscan 3 Wireless should not be used in proximity to or on top of other devices. If it must be, observe to verify that it works properly in the configuration in which it is used.
  • Page 22 The Aoralscan 3 Wireless is intended for use in the electromagnetic environment specified below. The customer or user of the Aoralscan 3 Wireless should assure that it is used in such an environment. Table 2-2 Guidance and Manufacturer's Statement - Electromagnetic emission Aoralscan 3 Wireless is intended to be used in the following electromagnetic environment.
  • Page 23 Interference immunity The Aoralscan 3 Wireless is intended for use in the electromagnetic environment specified below. The customer or user of the Aoralscan 3 Wireless should assure that it is used in such an environment. Guidance and Manufacturer's Statement - Electromagnetic emission Aoralscan 3 Wireless is intended to be used in the following electromagnetic environment.
  • Page 24 Guidance and Manufacturer's Statement - Electromagnetic emission Aoralscan 3 Wireless is intended to be used in the following electromagnetic environment. The purchaser or user of Aoralscan 3 Wireless should ensure that it is used in this electromagnetic environment: Immunity test...
  • Page 25 Guidance and Manufacturer's Statement - Electromagnetic emission Aoralscan 3 Wireless is intended to be used in the following electromagnetic environment. The purchaser or user of Aoralscan 3 Wireless should ensure that it is used in this electromagnetic environment: Electromagnetic environment –...
  • Page 26 If the measured field strength in the location in which the Aoralscan 3 Wireless is used exceeds the applicable RF compliance level above, the Aoralscan 3 Wireless should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Aoralscan 3 Wireless.
  • Page 27 50 kHz To limit exposure to electromagnetic interference from nearby equipment that can degrade image quality or launch warning messages, it is necessary to position the Aoralscan 3 Wireless further from sources of electromagnetic interference or install electromagnetic shielding to block unwanted interference.

  • Page 28: Biological Safety

    Aoralscan 3 Wireless, including cables specified by the manufacturer. Otherwise, it could lead to degradation of the performance of this equipment. ⚫ If immunity test level is higher than those specified in IEC60601-1-2, the minimum separation distance may be lowered. Lower minimum separation distances shall be calculated using the equation specified in IEC60601-1-2 Chapter 8.10.

  • Page 29: Scanner

    3. Scanner 3.1. Brief Introduction The Aoralscan 3 Wireless is designed to provide powder-free intraoral color scanning with higher speed of 20 FPS, bringing greater accuracy and less time-lag for image acquisition. It can be used to scan a single tooth, multiple teeth, and whole dental arches. Dental Order System Module helps manage the patient information and share data with others.
  • Page 30 2.A wireless AP. 3.Charge the scanner when connected with a wire. Charging case Charge the battery. Calibrator Calibrate the scanner. Battery Wireless power supply. Scanner tip 4 standard tips and 1 mini tip Dust cap Protect the scanner from dust. A detachable spare USB 2.0 cable for connecting Spare cable scanner and cradle.

  • Page 31: Hardware Overview

    emissions or decreased immunity to external EMI/EMC occurrences. Non-specified peripherals, and cables in some cases, can also increase leakage current or compromise the safety of the grounding scheme. ⚫ Using accessories or power supply units other than those specified may cause the warranty to void and result in increased emissions, decreased EMI immunity of the device, or even damages to the device and personal injuries.
  • Page 32 Use the scanner tip to scan the upper, lower or full jaw. The scanner tip can be recycled up to 100 times. Scanner tip The scanner can identify tips with different sizes and adjust the breadth of the camera according to the tip size automatically.
  • Page 33 Green: 1. The battery is inserted into the scanner. 2. The scanner is charged above 20% in the cradle. Flashing green: The battery power is less than 20%. Battery indicator Extinguished: 1. The scanner is in sleep mode. 2. The battery is not inserted into the scanner. Note:The battery indicator is extinguished in wired connection mode.

  • Page 34: Scanner Cradle

    3.3.2. Scanner Cradle Cradle indicator: Chassis indicator status description: Orange : device initialization or device abnormal, need your attention. Such as connection abnormalities, equipment failure. green is always on: scanner charging is complete or the cradle is in normal working condition.

  • Page 35: Usb Storage

    for 30 minutes, the scanner will automatically enter the dormant state. ⚫ When the cradle is not connected to power supplies and the scanner is put on the cradle for 10 minutes, the scanner will automatically enter the dormant state. ⚫...

  • Page 36: Software Overview

    3.4. Software Overview The Aoralscan 3 Wireless is designed to operate with the software programs (on the USB), which include four modules: ⚫ Calibration module Calibrate the scanner. ⚫ Dental order system module Designed to manage and store patient data, including cases, prescriptions, and restoration information, realizing functions such as order creation, editing, searching, scanning and deletion, as well as uploading, downloading, previewing and tracking of scanned order and data.

  • Page 37: Install The Software

    Windows Recommended configuration Name Description Intel Core i7-8700 or higher Memory 16 GB or higher 256 GB SSD or above Hard disk drive NVIDIA RTX 2060 6GB or higher Graphic card (GPU) Windows 10 Professional (64-bit) or later versions of Windows Operating system operating system Display Resolution...

  • Page 38: Set The Scanner

    or turn on the scanner yet. (1) Insert the supplied USB flash drive into the USB port of your PC. (2) Find the file and run it as administrator. (3) The Installation Wizard window appears to start the installation. (4) Specify a language from the drop-down list. (5) Click OK.
  • Page 39 in heated or wet surfaces as this can cause damage to the scanner. ⚫ It is normal that the scanner gets warm when in use. Do not block the ventilation holes on the bottom of the scanner. If the scanner overheats, the scanner will stop working. Warning Ensure that you use only the supplied power adapter, power cable, and USB cable.
  • Page 40 ① (4) Connect the USB cable line of the scanner to the USB 3.0 port on the cradle as shows. (5) Connect the calibrator and cradle via spare wire as ② shows. (6) Connect one end of the USB 3.0 cable line to the cradle and the other to the USB 3.0 port on the computer as ③...
  • Page 41 (8) Double-click the shortcut icon on the desktop to launch the software. Follow the steps to connect the scanner in the wireless mode: (1) Push the scanner tip hard to the scanner main body to ensure firm attachment. (2) Push the scanner hard and ensure the whole device is firmly attached. Aoralscan 3 Wireless_Manual _V2.0...
  • Page 42 (3) Insert the scanner into the cradle. (4) Click the shortcut icon on the desktop to launch the software. (5) Enter the interface of device connection and connect it via wireless AP binding. Note ⚫ Once connected, the software will search the bound device for re-connection next time.

  • Page 43: Calibrate The Scanner

    4.2. Calibrate the Scanner The Mac and iPad both support calibration by wireless Bluetooth. Note: Calibration by the wireless Bluetooth, please turn on the Bluetooth of the Mac and the iPad first. Under these circumstances, we recommend that you shall execute the calibration for the scanner to ensure the accuracy of scanned data: ⚫...
  • Page 44 Calibration in Wired Connection Mode (2) Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently slide the tip off from the scanner. Note ⚫ Do not place your finger(s) on the mirror of the tip when detaching as this may result in damage to the mirror.

  • Page 45: Disconnect The Scanner

    (5) Click the calibration icon on the main interface to display the calibration interface. (6) Ensure the scanner is plugged into the calibrator firmly. Click Start. Calibration begins. (7) The message prompting successful calibration appears once the calibration is completed. Click OK to exit. Note Normally the calibration takes approximately 7 minutes.
  • Page 46 (3) Right-click the “Safely Remove Hardware” icon on Windows taskbar and select “Eject Flash Drive”. (4) Unplug the USB flash drive and keep it in a safe place for future use. (5) Unplug the power adapter from the wall outlet and remove the power plug from the power port on the cradle.

  • Page 47: Scanning Preparations

    5. Scanning Preparations Warning Concerning hand hygiene and personnel safety when performing a scan, you must wear clean surgical gloves through the whole process. Intraoral Environment 5.1. ⚫ Make sure there is no foreign body or blood in the mouth after gargling. Stop the bleeding if necessary.

  • Page 48: Heat The Scanner Tip

    you are working on. ⚫ Hold the scanner steady by resting it on the tooth surface and keep the scan tip window in the range of -1 mm to 16 mm from the teeth. ⚫ When scanning, slowly move the scanner and simultaneously check the scan results on the screen to ensure that the scanning is of good quality.
  • Page 49 (3) Connect the power supply to the Aoralscan 3 Wireless. See Connecting the scanner in chapter 4. (4) Place the scanner in the cradle to secure it in place. (5) When the LED ring light on the scanner body lights up green, the heater automatically turns on and detects the temperature.

  • Page 50: Clinical Case Quick Guide

    If the customer has Shining 3D accounts, he can directly enter the account and password for login. If there are no Shining 3D accounts, please register an account. click New User? Click here to register to enter the registration interface.

  • Page 51: Scan Upper Jaw

    Click “Scan” and enter the scanning interface. 6.6. Scan Upper Jaw Please check whether the image on the camera window on the top right corner displays normally. Then click , or press space bar or press the button on the scanner to start scanning.
  • Page 52 The green box shows the current scanning data. If the box turns into red, it indicates that the user is scanning the wrong place and needs to move the scanner tip to the place the red box shows. When the scanner tip leaves the object or the scanning is paused, the green area means this area is not scanned.

  • Page 53: Scan Lower Jaw

    6.7. Scan Lower Jaw The steps of scanning lower jaw are the same as that of upper jaw. When finishing scanning upper jaw, the software will enter the process of scanning lower jaw automatically. 6.8. Scan Whole Jaw When finishing scanning upper jaw and lower jaw, the software will automatically enter the process of scanning whole jaw.
  • Page 54 After alignment Click when finishing scanning upper jaw and lower jaw, and aligning the model. Press space bar or press the button on the scanner can pause scanning and check the mode as well. Click , or long press space bar or press the button on the scanner for over 3 seconds to edit data.

  • Page 55: Check Scanning Results

    6.9. Check Scanning Results Check the model data. 6.9.1. Check Upper/lower Jaw 6.9.2. Check Occlusion Aoralscan 3 Wireless_Manual _V2.0...

  • Page 56: Pre-Design

    6.10. Pre-design For more details of pre-design, please check the User Manual. 6.10.1. Occlusion Test Click under the "Pre-design" process to enter the occlusion detection interface. ⚫ The green color indicates there is a distance between the two jaws. ⚫ The red color indicates the touching area between the two jaws. ⚫...
  • Page 57 ⚫ Switch upper and lower jaws: Switch by clicking the upper jaw icon and the lower jaw icon on the upper left corner. ⚫ Close/open jaw: Switch between the Close button and then Open button to see the occlusal result. ⚫...

  • Page 58: Check Undercut

    6.10.2. Check Undercut Click on the right side of the software to open the undercut interface. You can rotate the model to the appropriate view, double-click the view or click to recalculate undercut area. 6.10.3. AccuDesign On the pre-design interface, click to enter the AccuDesign interface.
  • Page 59 Note When creating a new order, select the Dentistry Type as Orthodontics to enable the orthodontic simulation function.. Pre-processing Edit the model data to make preparation for tooth segmentation. Tooth Segmentation Tooth segmentation will mark position of each tooth and distinguish them with different colors.
  • Page 60 Tooth Setup Tooth setup shows and visualize the effect of orthodontics. Features are following: ● You can create your own plans (Maximum is 3) and preview the effect. ● The process of orthodontics is displayed by animation. ● You can setup the teeth manually. Note You can click Setup to enter setup interface if the segmentation is completed.
  • Page 61 Animation Play the whole process of orthodontic treatment. Preview the effect of different treatment plans. Manual Setup You can set up the tooth manually. Aoralscan 3 Wireless_Manual _V2.0...

  • Page 62: Oral Report

    7. Care and Maintenance 7.1. Pre-cleaning, Disinfection, and Sterilization The whole set of Aoralscan 3 Wireless, including scanner tip, scanner body, and scanner cradle, requires proper care, cleaning, and handling. As individual part may be processed differently, read and follow the information and instructions given to help you effectively and thoroughly reprocess the set.

  • Page 63: Scanner Body And Cradle Care

    Follow the steps below to complete the disinfection: (1) Disconnect the power of the Aoralscan 3 Wireless (see Disconnecting the scanner on chapter 4). (2) Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently slide the tip off from the scanner.
  • Page 64 Note Do not place your finger(s) on the mirror of the tip when detaching as this may result in damage to the mirror. (3) Store the detached tip in a safe place, e.g. a dental instrument tray, prior to disinfecting the scanner body. Caution ⚫...

  • Page 65: Scanner Tip Care

    Cleaning and High-level Disinfection Follow the steps below to perform cleaning and high-level disinfection: (1) Disconnect the power of the Aoralscan 3 Wireless (see Disconnecting the scanner on chapter 4). (2) Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently slide the tip off from the scanner body.
  • Page 66 Caution Do not place your finger (s) on the mirror of the tip when detaching as this may result in damage to the mirror. (3) Pay particular attention to inspect the mirror of the tip to ensure that the mirror is not cracked or broken and there is no scratch on it.

  • Page 67: Cleaning And Steam Sterilization

    Cleaning and Steam Sterilization Follow the steps below to perform cleaning and steam sterilization: (1) Disconnect the power of the Aoralscan 3 Wireless (see Chapter 4). (2) Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently slide the scanner tip off from the scanner.
  • Page 68 Caution Do not place your finger(s) on the mirror of the tip when detaching as this may result in damage to the mirror. (3) Hold the supplied dust cap with the triangle mark facing upward. Then, align the dust cap blocks to the matching slots on the front end of the scanner body. Caution If the mirror of the tip has cracks or scratches, stop the cleaning process and contact your local distributor or service provider.

  • Page 69: Attach The Scanner Tip

    7.3.3. Attach the Scanner Tip There is a risk of damaging the mirror of tip if any improper actions are taken when attaching the tip to the scanner. Warning ⚫ Wear clean surgical gloves before you start. ⚫ Ensure that the scanner cradle, scanner body, and scanner tip are pre-cleaned and disinfected/sterilized (see Scanner body care on chapter 7 and Scanner storage on chapter 7).

  • Page 70: Scanner Storage

    7.4. Scanner Storage In case you need to transport the device, we strongly recommend that you keep the original packaging after unpacking the Scanner. Shipping the device without its original packaging material may cause possible product damage and result in additional service fees. If the original packaging is no longer available or damaged, carefully package each part of the scanner with bubble wrap to protect against any possible damage during transportation.

  • Page 71: Replace Battery

    ⚫ When the scanner tip is detached from the scanner body, always protect the subtle units and the inner optical components on the front end of the scanner by putting on the supplied dust cap. ⚫ Ensure the scanner is clean before long-term storage. ⚫...

  • Page 72: Charging Case Using Safety

    8. Hardware Specification Specifications 8.1. Parameter Description Type Name Intraoral Scanner Model Name Aoralscan 3 Wireless Scanner Standard tip: 16 mm × 12 mm Scan Field Mini tip: 12 mm × 9 mm Wireless Connection (powered by battery) Connection or Wired connection...

  • Page 73: Environmental Requirements

    Green laser: 520nm Blue laser: 448nm wave length White LED: 400nm-780nm Output STL、OBJ、PLY White LED: 400nm-780nm Power 12V DC/3.0 A Scanning tip dimensions 117mm × 34.5mm × 30mm Battery type Rechargeable battery 85mm× 37mm× 28mm Dimension（L×W×H） Weight 67± 5g Nominal voltage 3.635V Capacity 3500maH...

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