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Shining 3D Aoralscan 3 Manual

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Aoralscan 3
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V1.1

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Summary of Contents for Shining 3D Aoralscan 3

  • Page 1 Aoralscan 3 Manual V1.1...
  • Page 2 XL/MDR-RD-094 Foreword General The manual (hereinafter referred to as "the Manual") introduces the functions, installation, usage and maintenance of the Aoralscan 3 (hereinafter referred to as "the Scanner"). indicates the item is a medical device. Safety Instructions Signal Meaning Note：This symbol is used to inform you of the additional information of the product.
  • Page 3 XL/MDR-RD-094 companies, and are used for informational purposes only.  Shining 3D Tech Co., Ltd. makes no representations or warranties, either expressed or implied, with respect to the contents hereof and specifically disclaims any warranties, merchantability or fitness for any particular purpose.

  • Page 4: Table Of Contents

    XL/MDR-RD-094 Table of Contents Foreword ....................- 1 - 1. Read This First ..................- 6 - Basic Information ..............- 6 - Intended Use ................- 9 - Contraindications ..............- 10 - Warnings ................- 10 - Waste Electrical and Electronic Equipment ........ - 11 - Disposal .................
  • Page 5 XL/MDR-RD-094 Main Cables ..............- 30 - Software Overview ..............- 30 - System Requirements ............ - 31 - Install the Software ............- 31 - 5. Set the Scanner ................- 33 - Connect the Scanner ............... - 33 - Calibrate the Scanner ..............
  • Page 6 XL/MDR-RD-094 8. Care and Maintenance ..............- 46 - Pre-cleaning, Disinfection, and Sterilization ....... - 46 - Scanner Body and Cradle Care ..........- 47 - Scanner Tip ................- 48 - Cleaning and High-level Disinfection ....... - 49 - Cleaning and Steam Sterilization ........

  • Page 7: Read This First

    Product name: Intraoral scanner Model: Aoralscan 3 II. Name, residence, contact information and after-sales service of the manufacturer Manufacturer name: Shining 3D Tech Co., Ltd. Production Address: No. 1398, Xiangbin Road, Wenyan, Xiaoshan, Hangzhou, Zhejiang, China, 311258 III. Contact Information Manufacturer Shining 3D Tech Co., Ltd.
  • Page 8 XL/MDR-RD-094 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. Display: Under normal working conditions, when the scanner is opened for scanning, the two- dimensional and three-dimensional imaging of the scanned object (such as teeth) can be seen on the display respectively.
  • Page 9 XL/MDR-RD-094 flash drive, and the software release version is 1. Caution  It is recommended that users copy the software from the USB flash drive to the computer hard disk before installing the driver.  Use NVIDIA graphics cards to get the best scanning efficiency. ...

  • Page 10: Intended Use

    Caution  The Aoralscan 3 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 11: Contraindications

    Contraindications No known contraindications (or side effects). Warnings Before using the Aoralscan 3, read warnings and Safety information on chapter 2.  Do not attempt to disassemble, repair, or modify the scanner and software. Aoralscan 3_Manual_V1.1...

  • Page 12: Waste Electrical And Electronic Equipment

    XL/MDR-RD-094  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 13: Disposal

    Warranty The warranty is void if unauthorized personnel perform service or maintenance on the set of Aoralscan 3. To ensure correct product performance and to obtain warranty service, contact technical support. Aoralscan 3_Manual_V1.1 - 12 -...

  • Page 14: 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 15: Labels And Symbols

    XL/MDR-RD-094 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 16 XL/MDR-RD-094 Type BF applied part. To identify a type BF applied part complying with IEC 60601-1. Indicate that the contents of the transport package are fragile and the package shall be handled with care. Indicate that the transport package shall be kept away from rain and in dry conditions.

  • Page 17: Compliance

    XL/MDR-RD-094 Indicate the unique device identifier information. Note： The symbols meet the requirements of ISO 15223-1 2021"Medical devices - Symbols to be used with information to be supplied by the manufacturer Part1 General requirements". Compliance Anyone creating or changing a medical electrical system through a combination with other devices in accordance with standard IEC 60601-1:2005+AMD1:2012 Medical electrical equipment –...

  • Page 18: Classification

    41°C but will be maintained below 48°  All devices connected to the Aoralscan 3 shall comply with IEC 60601-1 and IEC 60950.  The radiation characteristics of the scanner is suitable for use in all locations ,including Aoralscan 3_Manual_V1.1...

  • Page 19: Emc Notice

    The guidance and manufacturer's statement are shown in the attached table. Warning  Aoralscan 3 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 20 Interference immunity The Aoralscan 3 is intended for use in the electromagnetic environment specified below. The customer or user of the Aoralscan 3 should assure that it is used in such an environment. Guidance and Manufacturer's Statement - Electromagnetic emission Aoralscan 3 is intended to be used in the following electromagnetic environment.
  • Page 21 Guidance and Manufacturer's Statement - Electromagnetic emission Aoralscan 3 is intended to be used in the following electromagnetic environment. The purchaser or user of Aoralscan 3 should ensure that it is used in this electromagnetic environment: Immunity test IEC 60601 test levels...
  • Page 22 If the measured field strength in the location in which the Aoralscan 3 is used exceeds the applicable RF compliance level above, the Aoralscan 3 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.
  • Page 23 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 further from sources of electromagnetic interference or install electromagnetic shielding to block unwanted interference.
  • Page 24 Aoralscan 3 Guidance and Manufacturer's Statement - Electromagnetic emission Aoralscan 3 is intended to be used in the following electromagnetic environment. The purchaser or user of Aoralscan 3 should ensure that it is used in this electromagnetic environment:...

  • Page 25: Biological Safety

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Aoralscan 3, including cables specified by the manufacturer. Otherwise, it could lead to degradation of the performance of this equipment.

  • Page 26: Unpack The Package

    XL/MDR-RD-094 3. Unpack the Package Check the carry box for the following items. If any item is missing or damaged, contact the distributor or service provider immediately. Note： The following figures in the parts list are for reference only, the actual product shall prevail if there is any inconsistency.
  • Page 27 XL/MDR-RD-094 USB 3.0 cable. Use it together with the calibrator USB 3.0 repeater package box Warranty &Quality certification Disinfection guidelines Quick start guide Warning  AC plug types vary by country/region.  Using accessories, peripherals, or cables not supplied with the product or recommended by Shining3D Corporation can affect the device in the form of increased emissions or decreased immunity to external EMI/EMC occurrences.

  • Page 28: Scanner

    4. Scanner Overview The Aoralscan 3 is designed to provide powder-free intraoral color scanning with higher speed, 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. The captured 3D digital images of teeth and soft-tissue areas are designed to be used in conjunction with the supplied software programs.

  • Page 29: Scanner Cradle

    XL/MDR-RD-094 scanning angle. During the scanning process, the scanner body may heat up, but the temperature will not cause harm to users and patients. Indicator Indicates the status of the scanner.  Green: The scanner is in scanning, heating or standby status.

  • Page 30: Usb 3.0 Repeater

    XL/MDR-RD-094 USB 3.0 Repeater Item Description Power port. USB 3.0 Data cable. Connect it to your PC USB3.0 port. 3.0 repeater Connect the port to the scanner. USB cable storage To prevent the USB cable from getting damaged by excessive bending or twisting, you should loosely coil the cable and avoid making kinks or sharp bends.

  • Page 31: Main Cables

    Length (m) Power adapter cable USB 3.0 repeater data cable Scanner connection cable Calibrator connection cable Software Overview The Aoralscan 3 is designed to operate with the software programs, which include four modules:  Calibration module Calibrate the scanner. ...

  • Page 32: System Requirements

    XL/MDR-RD-094 System Requirements Before installing and running the supplied software programs, your computer shall meet the following requirements: Intel Core i7-8700 or higher Memory 16 GB or higher 256 GB SSD or above Hard disk drive Graphic card (GPU) NVIDIA RTX 2060 6GB or higher Windows 10 Professional (64-bit) or later versions of Windows Operating system operating system...
  • Page 33 XL/MDR-RD-094 access. Aoralscan 3_Manual_V1.1 - 32 -...

  • Page 34: Set The Scanner

    XL/MDR-RD-094 5. Set the Scanner Connect the Scanner Caution  Ensure the supplied software programs are installed on your computer before the connection.  If the accuracy of the equipment decreases or if the equipment does not work properly, please consult technical support promptly. ...

  • Page 35: Calibrate The Scanner

    XL/MDR-RD-094 (3) Connect the USB 3.0 repeater to the USB 3.0 port on your PC. (4) Insert the power plug of the supplied power adapter into the power connector on the cradle, and plug the power adapter into a wall outlet. (5) Click the shortcut icon of IntraoralScan on the desktop to launch the software.
  • Page 36 XL/MDR-RD-094 Note  Do not place your finger(s) on the mirror of the tip when detaching as this may result in damage to the mirror.  Store the detached tip in a safe place, e.g. a dental instrument tray, for future use. Step 3 Connect the supplied calibrator and your computer with the supplied USB 3.0 cable.

  • Page 37: Disconnect The Scanner

    XL/MDR-RD-094 completed. Click OK to exit. Step 8 Gently slide the Calibrator off the scanner. Caution Make sure that the Calibrator is removed from the scanner after the calibration is done. Otherwise, the Calibrator temperature may get very high. Step 9 Reattach the scanner tip to the scanner for later use or put the dust cap onto the scanner to prevent damage and dust.

  • Page 38: Scanning Preparations

    XL/MDR-RD-094 6. 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  Make sure there is no foreign body or blood in the mouth after gargling. Stop the bleeding if necessary.

  • Page 39: Heat The Scanner Tip

    (2) Gently and carefully attach the scanner tip to the scanner body, with the mirror facing downward. (3) Connect the power supply to the Aoralscan 3. See Connecting the scanner in chapter 4. (4) Place the scanner in the cradle to secure it in place.
  • Page 40 XL/MDR-RD-094 It the temperature of the scanner tip is lower than the set point for anti-fogging, a notification message of pre-heating and current temperature appears. When the message disappears, the warm-up is done. The scanner is now ready for an acquisition.

  • Page 41: Clinical Case Quick Guide

    (every 15 days recommended). Register Account For users without other Shining 3D account, register account first. Click New User? Click here to register. The register interface is displayed. Select Forget Password or enter user info. Mind that you need to select Read and agree with it.

  • Page 42: Scan Upper Jaw

    XL/MDR-RD-094 Click Scan. Scanning begins. Scan Upper Jaw Confirm that the image of the camera window in the upper right corner of the software is displayed normally. Click or press the Space key or press the scanner body button to start scanning.

  • Page 43: Scan Lower Jaw

    XL/MDR-RD-094 frame. When the scanner tip leaves the object or the scanning is paused, the green area means this area is not scanned. User can rescan the corresponding area according to the demand. Confirm that the model scan is complete. Click or long press the Space key or press the scanner body button to process and save the data.
  • Page 44 XL/MDR-RD-094 Before alignment After alignment After the upper and lower jaws’ data are aligned successfully as well as the whole jaw, click or press the Space key to pause the scanning, check the occlusion. Aoralscan 3_Manual_V1.1 - 43 -...

  • Page 45: View Result Data

    XL/MDR-RD-094 View Result Data View result data in IntraoralScan. View Upper/Lower Jaw Aoralscan 3_Manual_V1.1 - 44 -...

  • Page 46: View Occlusal Effect

    XL/MDR-RD-094 View Occlusal Effect Pre-Design View Data Storage Path Click under New Order to return to the order interface and click to open the folder path of the current order storage. Upload Order Click to upload the scanned order. Aoralscan 3_Manual_V1.1 - 45 -...

  • Page 47: Care And Maintenance

    8. Care and Maintenance Pre-cleaning, Disinfection, and Sterilization The whole set of Aoralscan 3, 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 48: Scanner Body And Cradle Care

    Follow the steps below to complete the disinfection: (1) Disconnect the power of the Aoralscan 3 (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 49: Scanner Tip

    XL/MDR-RD-094  When the scanner tip is detached, always protect the subtle units and the inner optical components on the front end of the scanner by putting on the supplied dust cap.  Do not attempt to clean the outer units and inner optical components on the front end of the scanner with any sharp objects or other such tools, which may result in scratches and damage to the scanner.

  • Page 50: Cleaning And High-Level Disinfection

    Follow the steps below to perform cleaning and high-level disinfection: (1) Disconnect the power of the Aoralscan 3 (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 51: Cleaning And Steam Sterilization

    Follow the steps below to perform cleaning and steam sterilization: (1) Disconnect the power of the Aoralscan 3 (see 5.3 Disconnect the Scanner). (1) 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 52: Attach The Scanner Tip

    XL/MDR-RD-094 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.

  • Page 53: Scanner Storage

    XL/MDR-RD-094 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 10 and Scanner storage on chapter 10). Follow the steps below to complete the attachment: (1) Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently attach the tip facing downward to the scanner.

  • Page 54: Storage For Transport

    XL/MDR-RD-094 scanner with bubble wrap to protect against any possible damage during transportation. Storage for Transport  Make sure that the scanner is clean before placing it in the original carry box/package to avoid any possible contamination.  Place each part of the product, e.g. the tip, scanner body, cradle, power adapter, in the original package carefully and prevent kinks of the cable.

  • Page 55: Hardware Specification

    XL/MDR-RD-094 9. Hardware Specification Specifications Parameter Description Type Name Intraoral Scanner Model Name Aoralscan 3 Scanner Connection Wired connection Standard tip: 16 mm × 12 mm Scan Field Mini tip: 12 mm × 9 mm Scanning tip dimensions 120 mm ×...

  • Page 56: Environmental Requirements

    XL/MDR-RD-094 Environmental Requirements Operating and storage requirements  Operating temperature: 10°C–40°C  Operating Relative humidity: 30%RH~80%RH  Storage/Transport temperature: -30°C–60°C  Storage/Transport/Relative humidity: 30%RH–90%RH  Air pressure: 70kPa–106 kPa Aoralscan 3_Manual_V1.1 - 55 -...

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