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Shining 3D Aoralscan Elite Instructions For Use Manual

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Aoralscan Elite
Instructions for Use
V1.0

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Summary of Contents for Shining 3D Aoralscan Elite

  • Page 1 Aoralscan Elite Instructions for Use V1.0...
  • Page 2 Foreword General The instructions for use (hereinafter referred to as "the Instructions") introduces the functions, installation, usage and maintenance of the Aoralscan Elite (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 ⚫ 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. Further, Shining3D Corporation reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation of Shining3D Corporation to notify any person of such revision or changes.
  • Page 4 Table of Content Foreword ..........................- 1 - Read This First ...................... - 6 - 1.1. Basic Information ..................- 6 - 1.2. Intended Use ....................- 10 - 1.3. Contraindications ..................- 12 - 1.4. Warnings ....................- 12 - 1.5.
  • Page 5 5.2. Calibrate the Scanner ................. - 34 - 5.3. Disconnect the Scanner ................- 35 - Scanning Preparations..................- 36 - 6.1. Intraoral Environment ................- 36 - 6.2. Scanner Preparation ................... - 36 - 6.3. Scanning Position and Path ................ - 36 - 6.4.
  • Page 6 8.2. Scanner Body, Cradle and Calibrator Care ..........- 48 - 8.3. Scanner tip maintenance ................- 50 - 8.3.1. Cleaning steps ................- 50 - 8.3.2. High-level disinfection steps ............- 51 - 8.3.3. High temperature autoclave sterilization steps ......- 52 - 8.3.4.
  • Page 7 Catalogue number: G, DG, GR, B, DB, BR and S. 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 III. Contact Information Manufacturer Shining 3D Tech Co., Ltd.
  • Page 8 Product performance Indicator Appearance and structure: The appearance should be smooth, crackless, stainless with no obvious deformation. The device should be flexible and reliable for operation. Requirements for operating and controlling: The design and positioning for the operation and control of the Scanner should be able to prevent accidental starting.
  • Page 9 Morphological accuracy refers to the degree of consistency between the test result data and the 3D morphology of the whole surface of the tested object. The standard deviation of this morphological accuracy of the big scanner tip and the mini scanner tip shall meet the requirements: Scanner tip specification Measurement range...
  • Page 10 ⚫ 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. ⚫ Do not insert wireless USB network card in the computer. USB wireless network card will cause USB bandwidth occupation, limiting camera performance.
  • Page 11 Caution ⚫ The Aoralscan Elite 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 scanner can directly scan inside the patient's mouth to obtain three-dimensional morphology and color texture information of soft and hard tissue surfaces such as teeth, gums, and mucous membranes in the oral cavity, facilitating comfortable data capturing for patients, reducing stress for medical care, and improving efficiency for following processing.
  • Page 13 Photosensitive epilepsy patients. There is a risk of epileptic shock from the flashing light of the scanner. 1.4. Warnings Before using the Aoralscan Elite, read warnings and Safety information on chapter 2. ⚫ Do not attempt to disassemble, repair, or modify the scanner and software.
  • Page 14 For specific information on disposal of your device and the packaging, contact your local distributor or service provider. 1.7. Warranty The warranty is void if unauthorized personnel perform service or maintenance on the set of Aoralscan Elite. To ensure correct product performance and to obtain warranty service, contact technical support.
  • Page 15 ⚫ 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 ⚫ Do not put matched plugs and USB ports in a place where it is difficult to disconnect the device. ⚫ Reasonably arrange all types of cables to prevent users or patients from tripping over the wires. Do not forcibly pull or bend cables of any kind. ⚫...
  • Page 17 Indicate that the marked item or its material is part of a recovery or recycling process. Indicate the maximum and minimum temperature limits at which the item shall be stored, transported or used. Indicate the acceptable upper and lower limits of relative humidity for transport and storage.
  • Page 18 devices in accordance with standard IEC 60601-1:2005+AMD1:2012+AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance is responsible for ensuring that the requirements of these standards are met to the full extent to ensure the safety of patients, operators and the environment. 2.4.
  • Page 19 Warning ⚫ Aoralscan Elite 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 The Aoralscan Elite is intended for use in the electromagnetic environment specified below. The customer or user of the Aoralscan Elite should assure that it is used in such an environment. ’ Guidance and manufacturer s declaration–electromagnetic emissions...
  • Page 21 Interference immunity The Aoralscan Elite is intended for use in the electromagnetic environment specified below. The customer or user of the Aoralscan Elite should assure that it is used in such an environment. Guidance and Manufacturer's Statement - Electromagnetic emission Aoralscan Elite is intended to be used in the following electromagnetic environment.
  • Page 22 Guidance and Manufacturer's Statement - Electromagnetic emission Aoralscan Elite is intended to be used in the following electromagnetic environment. The purchaser or user of Aoralscan Elite should ensure that it is used in this electromagnetic environment: Immunity test...
  • 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 Elite further from sources of electromagnetic interference or install electromagnetic shielding to block unwanted interference.
  • Page 24 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 Elite, including cables specified by the manufacturer. Otherwise, it could lead to degradation of the performance of this equipment.
  • Page 25 This product is a class 1 laser product and is only for maintenance, replacement and removal by professional personnel of the manufacturer or its designated agent (if necessary). If the device is not used, removed or replaced as required, the normal use of the device may be affected and laser radiation may occur.
  • Page 26 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 2. The mini tip is intended to be used for patients who can not fully open their mouth, or for scanning narrow areas in the mouth (such as the back teeth area, etc.). Please do not use the mini tip for other purposes. Dust cap for the scanner body Dust cover for the calibrator USB flash disk...
  • Page 28 4. Scanner 4.1. Overview The Aoralscan Elite 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 Double press to enter the button interface. Scanner Rotate the scanner body during scanning to obtain the best scanning angle. body 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.
  • Page 30 go out. ⚫ If the scanner is not placed on the cradle and is idle for more than 3 minutes, it will automatically enter standby mode. After another 10 minutes, it will enter sleep mode. ⚫ The scanner tip is still heated when the scanner is in standby mode. 4.2.3.
  • Page 31 4.3. Software Overview The Aoralscan Elite is designed to operate with the software programs, 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 32 4.3.2. Install the Software The USB flash drive contains the IntraoralScan software program. Caution ⚫ Install the software programs in accordance with the instructions given here. ⚫ When the installation is completed, do not plug the power adapter to the wall outlet or turn on the scanner yet.
  • Page 33 transmitted will be invalidated without causing impact. ⚫ Network access: (1) After accessing the network, the software will automatically connect to the cloud platform and obtain information about the software-connected devices, while users can upload patients and order data information on the cloud platform by registering and logging into their accounts through the software.
  • Page 34 them on a slanted surface. ⚫ Always hold the scanner firmly when lifting from the stand or when using the scanner. Do not shake the scanner. ⚫ Always return the scanner to the cradle when it is not in use. Do not place the scanner in heated or wet surfaces as this can cause damage to the scanner.
  • Page 35 Step 3 Connect the supplied calibrator and your computer with the supplied USB 3.0 cable. Note Aoralscan Elite can be connected with an all-in-one machine or an external touch screen. Step 4 Gently slide the calibrator onto the front end of the scanner.
  • Page 36 Step 5 Click on the main interface to display the calibration interface. Step 6 Ensure the scanner is plugged into the calibrator firmly. Click Start. Calibration begins. Note Normally the calibration takes approximately 7 minutes. Step 7 The message prompting successful calibration appears once the calibration is completed.
  • Page 37 (2) Disconnect the scanner cable from the computer. 6. Scanning Preparations Warning Concerning hand hygiene and personnel safety when performing a scan, you must wear clean surgical gloves through the whole process. 6.1. Intraoral Environment ⚫ Make sure there is no foreign body or blood in the mouth after gargling. Stop the bleeding if necessary.
  • Page 38 (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 Elite. See Connecting the scanner in chapter (4) Place the scanner in the cradle to secure it in place.
  • Page 39 (5) When the LED ring light on the scanner body lights up green, the heater automatically turns on and detects the temperature. 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.
  • Page 40 See 5.1 Connect the Scanner. 7.2. 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 41 Click Scan. Scanning begins. 7.6. 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 42 The green frame in the middle of the software interface indicates the data range of the current scanning. If the green frame changes to a red frame, as shown in the figure below, the scan position is incorrect. You need to move the scanner tip to scan the data displayed in the red frame.
  • Page 43 7.8. Scan Total Jaws After the lower jaw scanning and the data processing are finished, the total jaw scanning interface is automatically displayed. Click or press the Space key or press the scanner body button to start scanning. After scanning some data, the software automatically performs dynamic bite alignment, as shown below.
  • Page 44 7.9. Coded Scanbody Scanning Coded scanbody scanning is supported. After scanning the jaws and coded scanbody, the software will align the mark scan body to the jaws. 7.10. View Result Data View result data in IntraoralScan. 7.10.1. View Upper/Lower Jaw 7.10.2.
  • Page 45 interface and make comparison. Click on the compared models to check the results. 7.11. Pre-Design 7.11.1. Texture and Smooth Texture: Click to view the texture of the model. Open Close Smooth: Click to clean the noise and improve the quality of the model. Open Close 7.11.2.
  • Page 46 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. Occlusion adjustment : Click this icon to open the occlusion adjustment parameters.
  • Page 47 area. 7.11.4. AccuDesign On the pre-design interface, click to enter the AccuDesign interface. AccuDesign is a model generation software. Use it to generate solid or hollow model out of the scanned data by 3D scanner. You can add attachments to the model, such as text, frame, and drain hole in a convenient way.
  • Page 48 detailed information of the symptoms and relevant solutions, which can be used for patient management and organisational diversion. Click on the pre-design interface to enter the oral report settings interface, which provides access to the oral report function. For more details, please check the User Manual.
  • Page 49 8. Care and Maintenance 8.1. Pre-cleaning, Disinfection, and Sterilization The whole set of Aoralscan Elite, including scanner tip, scanner body, scanner cradle and the calibrator, 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 50 Ensure that the scanner tip is detached from the scanner, and the dust cap is put on scanner when disinfecting the scanner body. Follow the steps below to complete the disinfection: Disconnect the power of the scanner (see more details in Connection and disconnection). Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently slide the tip off from the scanner.
  • Page 51 damage to the scanner. 8.3. Scanner tip maintenance The scanner tip is the most essential part of the scanner as it is inserted into your patient’s mouth during scanning. Therefore, the tip must be thoroughly cleaned and sterilized before and after each patient contact in order to prevent cross- contamination in your operation.
  • Page 52 ⚫ Do not place your finger (s) on the lens of the tip when detaching as this may result in damage to the lens. ⚫ 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 53 Discard the used distilled water. Do not reuse the water for rinsing or any other purpose. 3. Flush the tip with distilled water for at least 3 minutes. 4. Dry the tip with a soft, lint-free cloth and put it in a well-ventilated place to make sure it is totally dry, or put it in a dryer for 30 minutes.
  • Page 54 Caution Do not place your finger(s) on the mirror of the tip when attaching as this may result in damage to the mirror. (2) Try swiveling the scanner tip around to ensure it is locked into position and stable. (3) Place the scanner in the cradle, and the set is ready for use. 8.4.
  • Page 55 package carefully and prevent kinks of the cable. ⚫ Make sure that each cable is rolled up and tangle-free before placing it in the original carry box. ⚫ Before closing the lid, make sure no part of the product is protruding from the package. 8.4.2.
  • Page 56 9.1. Specifications Parameter Description Type name Intraoral Scanner Model name Aoralscan Elite Scanner Scanner tip types Big Scanner Tip, Standard Scanner Tip and Mini Scanner Tip Big Scanner Tip: 19 mm × 14 mm Scan field (L×W) Standard Scanner Tip: 16 mm × 12 mm Mini Scanner Tip: 12 mm ×...
  • Page 57 Cradle size (L×W×H) 103±3 mm × 80±2 mm × 67±2 mm Cradle weight 242±20 g Device lifecycle 8 years Calibrator Calibrator size (L×W×H) 236±3 mm × 50±2 mm × 50±2 mm Calibrator weight 431±30 g Calibrator cable length 1.5 m 9.2.