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Table of contents

Chapter 1: Read this first ......................................................................................... 1
Copyright.......................................................................................................................1
Disclaimer ......................................................................................................................1
Intended use ..................................................................................................................2
Warnings.......................................................................................................................3
WEEE ............................................................................................................................3
Disposal .........................................................................................................................3
Typographics .................................................................................................................4
Warranty .......................................................................................................................4
Contact information .......................................................................................................4
Chapter 2: Safety information ................................................................................. 5
Precautions ...................................................................................................................5
Legend of labels and symbols .......................................................................................7
On the device.............................................................................................................7
On the carry box/package..........................................................................................7
Compliance ....................................................................................................................9
FCC compliance statement............................................................................................9
Electrical safety .............................................................................................................9
EMC notice ..............................................................................................................10
Electromagnetic emissions ..................................................................................10
Interference immunity ..........................................................................................11
Separation distances ...........................................................................................15
Chapter 3: Overview ............................................................................................... 17
Benefits of the product .................................................................................................17
Carry box list ................................................................................................................17
Scanner overview ........................................................................................................19
Tip and scanner body ..............................................................................................19
Scanner cradle.........................................................................................................20
USB cable storage ...................................................................................................21
Software overview........................................................................................................22
System requirements ...............................................................................................22
Installing the software programs ..............................................................................23
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  • Page 1: Table Of Contents

    Table of contents Chapter 1: Read this first ..................1 Copyright........................1 Disclaimer ........................1 Intended use ........................2 Warnings........................3 WEEE ..........................3 Disposal .........................3 Typographics .........................4 Warranty ........................4 Contact information .......................4 Chapter 2: Safety information ................. 5 Precautions ........................5 Legend of labels and symbols ..................7 On the device......................7 On the carry box/package..................7 Compliance ........................9...
  • Page 2 Chapter 4: Setting up the scanner ................ 25 Connecting the scanner ....................25 Disconnecting the scanner...................27 Calibrating the scanner ....................27 Chapter 5: Scanning preparation ................31 Scanning basics ......................31 Tooth preparation.....................31 Scanner preparation ....................31 Scanning position and path..................32 Heating the scanner tip ....................33 Chapter 6: Using DentalManager ................
  • Page 3 Scanner tip care.......................63 Cleaning and high-level disinfection ..............64 Cleaning and steam sterilization ................66 Attaching the scanner tip ..................67 Scanner storage......................68 Storage for transport ....................68 Daily and long-term storage..................68 Chapter 9: Hardware specification ............... 69 Specifications .......................69 Environmental requirements ..................70...
  • Page 5: Chapter 1: Read This First

    CHAPTER Read this first The Intraoral Scanner is an intraoral scanner that works with the supplied software programs. With Intraoral Scanner, you can perform oral scanning and digitally acquire and save the 2D/3D color images of a patient’s teeth for orthodontic, implant, and restoration use.
  • Page 6: Intended Use

    Intraoral Scanner User Manual Updates to hardware and/or software components are made regularly; therefore, some of the instructions, illustrations, and specifications mentioned in this User Manual may differ slightly from your particular situation. To obtain the most updated and accurate information, visit en.shining3d.com...
  • Page 7: Warnings

    Intraoral Scanner User Manual Warnings Before using the Intraoral Scanner, read these warnings and Safety information on page WARNINGS • Do not attempt to disassemble, repair, or modify the scanner and software. There are no user serviceable parts inside the scanner. Necessary modifications must be made only by the manufacturer or its designated agents.
  • Page 8: Typographics

    Warranty The warranty is void if unauthorized personnel perform service or maintenance on the set of Intraoral Scanner. To ensure correct product performance and to obtain warranty service, contact technical support. For more information, see Contact...
  • Page 9: Chapter 2: Safety Information

    CHAPTER Safety information Precautions WARNING Follow the procedures carefully and ensure that the power/electrical/environmental requirements are satisfied. Failure to observe the instructions or disregard the warnings may result in damages to the product, personal injury, or even death of the user or the patient.
  • Page 10 Intraoral Scanner User Manual • If the hardware or software is modified, appropriate inspection and testing must be conducted to ensure continued safe use. • Use only supplied accessories and approved software with the scanner in order to achieve the designed performance.
  • Page 11: Legend Of Labels And Symbols

    Intraoral Scanner User Manual Legend of labels and symbols The following symbols provide information on the product’s labels and regulatory compliance. On the device Table 2-1 Labels and symbols on the device Symbol Explanation General warning – caution. Indicates that the device complies with requirements for the BF type applied part according to IEC 60601-1, providing protection against electric shock.
  • Page 12 Intraoral Scanner User Manual Table 2-2 Labels and symbols on the carry box/package Indicates that the user should read the operating instructions for information on using this equipment. Indicates that the final disposal of the device complies with Waste Electrical & Electronic Equipment and waste regulations. It can no longer be used for its intended purposes.
  • Page 13: Compliance

    Intraoral Scanner User Manual Compliance Anyone creating or changing a medical electrical system through a combination with other devices in accordance with standard EN 60601-1-1:2001 based on 60601-1- 1:2000 (specification for the safety of medical electrical systems)/UL 60601-1 Part 1:...
  • Page 14: Emc Notice

    • Check the cable housing before use. Do not use if the housing is damaged or the cable is abraded. • All devices connected to the Intraoral Scanner shall comply with IEC 60601- 1 and IEC 60950.
  • Page 15: Interference Immunity

    Interference immunity The Intraoral Scanner is intended for use in the electromagnetic environment specified below. The customer or user of the Intraoral Scanner should assure that it is used in such an environment. Table 2-4 Guidance and manufacturer’s declaration – electromagnetic immunity...
  • Page 16 (100% dip in interruptions ) for 0.5/1 ) for 0.5/1 hospital environment. If the and voltage cycle cycle user of the Intraoral Scanner variations on requires continued operation power supply during power mains 40% U 40% U input lines interruptions, it is...
  • Page 17 Intraoral Scanner User Manual Table 2-4 Guidance and manufacturer’s declaration – electromagnetic immunity Immunity test IEC 60601 Compliance Electromagnetic test levels level environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the Aoralscan,...
  • Page 18 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Intraoral Scanner is used exceeds the applicable RF compliance level above, the Intraoral Scanner should be observed to verify normal operation.
  • Page 19: Separation Distances

    Intraoral Scanner User Manual Separation distances The Intraoral Scanner is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Intraoral Scanner can help prevent electromagnetic interference by maintaining a...
  • Page 20 • 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 Intraoral Scanner, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 21: Chapter 3: Overview

    2 meters) 2. 1 x scanner cradle (12 Vdc, 1.67 A) 3. 1 x protection cap 4. 2 x scanner tip (1 is already attached to the intraoral scanner when shipped) 5. 1 x Calibrator 6. 1 x USB 3.0 cable (for the connection between the cradle and your computer;...
  • Page 22 Intraoral Scanner User Manual 9. 1 x 2-in-1 USB dongle (the license key for authorized access; containing the software programs for patient data management (DentalManager) and scanning software (IntraOralScan) for Windows) 10. 1 x carry box WARNINGS • AC plug types vary by country/region.
  • Page 23: Scanner Overview

    Intraoral ScannerUser Manual Scanner overview Tip and scanner body Table 3-1 Introduction to the scanner tip and scanner body Component Function Use the tip to scan the upper jaw, lower jaw, or full jaw. Scanner tip The tip(s) can be autoclaved up to 20 times. The anti-condensation heater prevents fogging on the Heater mirror to ensure successful scanning.
  • Page 24: Scanner Cradle

    Intraoral Scanner User Manual Table 3-1 Introduction to the scanner tip and scanner body Component Function Hold the scanner body on the sides and rotate the scanner body to obtain the best scan angle. The scanner Scanner body body may get warm during scanning, yet the temperature won’t cause harm to the user and the patient.
  • Page 25: Usb Cable Storage

    Intraoral ScannerUser Manual NOTES • When the scanner is left idle for 10 minutes (including being placed on a desk), it will go into standby mode. After 1 minute of inactivity, it will automatically go into sleep mode, and the LED ring light on the end of the scanner body will also go off.
  • Page 26: Software Overview

    Intraoral Scanner User Manual Software overview The Intraoral Scanner is designed to operate with the following software programs (supplied in the 2-in-1 USB dongle): 1. Dental database software -- DentalManager Designed to manage and store patient data, including cases, prescriptions, and restoration information.
  • Page 27: Installing The Software Programs

    Intraoral ScannerUser Manual Installing the software programs The supplied 2-in-1 USB dongle contains these software programs: DentalManager and IntraOralScan. CAUTIONS • 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 29: Chapter 4: Setting Up The Scanner

    CHAPTER Setting up the scanner Connecting the scanner CAUTIONS • Ensure the supplied software programs are installed on your computer before the connection. • Install the scanner in accordance with the instructions stated in this User Manual. • Use the scanner only in dental laboratories, dental clinics, and equivalent environment.
  • Page 30 Intraoral Scanner User Manual Follow the steps below to complete the connection: 1. Make sure the scanner tip is firmly attached to the front end of the scanner; otherwise, gently and firmly slide the scanner tip onto the front-end of the scanner, as illustrated.
  • Page 31: Disconnecting The Scanner

    Intraoral Scanner User Manual Disconnecting the scanner CAUTION Do not attempt to directly disconnect the scanner by removing the power cable and USB cable. Follow the steps below to safely disconnect the scanner: 1. Quit the IntraOralScan scanning software. 2. Turn off the power switch on the cradle.
  • Page 32 Intraoral Scanner User Manual 6. Hold the scanner tip firmly with your thumb and forefinger on both sides, and then gently slide the tip off from the scanner, as illustrated. NOTES • Do not place your finger(s) on the mirror of the tip when detaching as this may result in damage to the mirror.
  • Page 33 Intraoral Scanner User Manual Click Calibration. 11. Click Start. The status bar shows the percentage of completion. NOTE It is normal that the calibration takes approximately 5 minutes. 12. The following message appears once the calibration is completed. Click OK to exit.
  • Page 34 Intraoral Scanner User Manual 14. Re-attach the scanner tip to the scanner for later use or put the protection cap onto the scanner to prevent damage and dust.
  • Page 35: Chapter 5: Scanning Preparation

    CHAPTER Scanning preparation Scanning basics Read and follow the guidelines and tips given in this chapter prior to acquiring quality images. WARNING Concerning hand hygiene and personnel safety when performing a scan, you must wear clean surgical gloves through the whole process. Tooth preparation •...
  • Page 36: Scanning Position And Path

    Intraoral Scanner User Manual • Ensure that the scanner connection is ready; it is correctly connected to a power source and powered on, and DentalManager and IntraOralScan are launched and ready to work. • To avoid condensation on the mirror of the tip when scanning, the scanner tip must have been warmed up.
  • Page 38: Heating The Scanner Tip

    Intraoral Scanner User Manual Heating the scanner tip In order to obtain optimal image quality, you should prevent condensation on the scanner mirror before each scan by heating the scanner tip. Follow the steps below to warm up the scanner before starting an acquisition: 1.
  • Page 39: Chapter 6: Using Dentalmanager

    CHAPTER Using DentalManager Introduction to DentalManager DentalManager is designed to work with the scanner to manage patient data and treatment reports, which are automatically saved by the supplied scanning software -- IntraOralScan. It also exchanges data between the dental laboratories/technicians and the dentists. Navigating DentalManager interface To run DentalManager, the following requirements must be met: •...
  • Page 40: Work Flow

    Intraoral Scanner User Manual Work flow Creating a project Click Project and select New to create a new order. Fill out the necessary order information, including the names of dentist(s), patient, and technician(s). Then click Next to proceed. Or select Load to open an existing project.
  • Page 41: Sharing Data

    Intraoral Scanner User Manual Sharing data Creating an account 1. Double-click SnFtpAccountMgr.exe. 2. In the window that appears, enter the FTP host, port, user name, and password. 3. Click Create to add a new FTP account with encryption (in .prcdat file format), by which you may login to DentalManager.
  • Page 42: Uploading The Data

    Intraoral Scanner User Manual To log in to the account: 1. Select the imported account file from the drop-down menu. 2. When the Login button is highlighted in blue, click the button. 3. When you have successfully logged in, click to close the window.
  • Page 43: Downloading The Data

    Intraoral Scanner User Manual Downloading the data 1. Click Download to display the information on the downloaded files. You may view the files by category: All, Downloaded, and Data Not Downloaded. 2. After finishing downloading, the download list is updated.
  • Page 45: Chapter 7: Using Intraoralscan

    CHAPTER Using IntraOralScan Introduction to IntraOralScan IntraOralScan is designed with a graphical user interface (GUI), so you will be guided step-by-step through the process of each task. Before performing a scan, understand and learn the features of the software. Navigating IntraOralScan interface Double-click the shortcut icon of IntraOralScan on your desktop , then one of the following main screens appears.
  • Page 46 Intraoral Scanner User Manual b. If the scanner is detected, the workspace appears as below. NOTE If IntraOralScan is already open, you cannot launch another instance of this program. The following table provides a general overview of IntraOralScan: Table 6-1 Functions of IntraOralScan...
  • Page 47 Intraoral Scanner User Manual Table 6-1 Functions of IntraOralScan Function Description Fit View Select to restore the image of the scanned model to its original size. Rotate Select and place the mouse pointer over the image of the scanned model, then you can left click and drag the mouse pointer to rotate the image to the desired orientation.
  • Page 48 Intraoral Scanner User Manual Table 6-1 Functions of IntraOralScan Function Description Start/Pause To activate or pause scanning, select this button to start/pause/resume. Reset Delete the whole scanned data to start over. Stop Scan menu To save the scanned data, select this button to complete the scan task.
  • Page 49: Guidance

    Intraoral Scanner User Manual Guidance When the installation of the Intraoral Scanner is ready, double-click the shortcut icon IntraOralScan on your desktop . The initial screen appears as below: Table 6-2 Overview of Guidance Displays Description The initial status of the Guidance icon.
  • Page 50 Intraoral Scanner User Manual Table 6-2 Overview of Guidance Displays Description 1. Select “>>” to proceed to the next step - Scan occlusal side. 2. Select “<<” to return to the previous step - Adopt S curve to scan jaw.
  • Page 51: Scanning Work Flow And Tools

    Intraoral Scanner User Manual Scanning work flow and tools After closing the window of Guidance, the following screen appears: By default, the entire scanning work flow starts with the upper jaw, then the lower jaw, and finally the full jaw.
  • Page 52 Intraoral Scanner User Manual Table 6-3 Scanning work flow and tools Work flow Tool icon Description icon The Pause button. When the button is selected, it changes to During the pause, you may examine the scanned data in the 3D view window and check if any areas need to be re-scanned.
  • Page 53 Intraoral Scanner User Manual Table 6-3 Scanning work flow and tools Work flow Tool icon Description icon When the scan of the upper jaw is done, IntraOralScan automatically guides you to the next task - scanning the lower jaw. If you wish to re-scan the upper jaw, select the icon of the upper jaw, and then select the Scan button.
  • Page 54 Intraoral Scanner User Manual Table 6-3 Scanning work flow and tools Work flow Tool icon Description icon The Scan button. The Pause button. During the pause, IntraOralScan automatically aligns the acquired data of upper jaw, lower jaw, and full jaw.
  • Page 55 Intraoral Scanner User Manual Table 6-3 Scanning work flow and tools Work flow Tool icon Description icon Others Scanning The Scanning Timer is at the upper right corner of the 3D view Timer window: The timer shows: 1. The total scanning time for the upper and lower jaws.
  • Page 56: 2D View Window

    Intraoral Scanner User Manual 2D view window Table 6-4 Tools for 2D view window Tool icon Description The 2D view window button. After activating IntraOralScan, the 2D view window appears by default. To close the window, select this button. The 2D view window displays the real-time image of the model during scanning.
  • Page 57 Intraoral Scanner User Manual Table 6-4 Tools for 2D view window Tool icon Description The Zoom button. Use the button to enlarge the 2D view window to see more details or resume it to the default size. The default 2D view window: The enlarged 2D view window: The Capture button.
  • Page 58: Edit Tools

    Intraoral Scanner User Manual Edit tools Table 6-5 Icon status Tool icon Status If the function is available, the button is highlighted in white. If the function is in use, the button is highlighted in blue. If the function is disabled, the button is gray.
  • Page 59 Intraoral Scanner User Manual Table 6-6 Tools for editing Tool icon Description • After selecting Fit View: Rotate Left click and drag the mouse pointer to rotate the image to the desired orientation. Move Left click and drag the mouse pointer to move the image to the desired position.
  • Page 60 Intraoral Scanner User Manual Table 6-6 Tools for editing Tool icon Description Delete Select to delete the specified area (the area in red). The button is only available when you have selected an area. Remove redundant 3D proliferation Select to automatically remove the redundant or unnecessary data from the scanned image.
  • Page 61 Intraoral Scanner User Manual Table 6-6 Tools for editing Tool icon Description The Undercut button. Select to automatically detect and measure the undercut area of the tooth. During the pause, you may select this button to view the effects of blocking the undercuts of the tooth, as shown below: The green arrow indicates the insertion axis.
  • Page 62: Menu Tools

    Intraoral Scanner User Manual Table 6-6 Tools for editing Tool icon Description Texture The default setting is on. When the function is on, the real-time scan is displayed in color. When the function is off, the real-time scan is displayed in monochrome.
  • Page 63: Chapter 8: Care And Maintenance

    Care and maintenance Pre-cleaning, disinfection, and sterilization The whole set of Intraoral Scanner , 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 64: Scanner Cradle Care

    • Ensure that the scanner body is not placed in the cradle prior to disinfecting the scanner cradle. Follow the steps below to complete the disinfection: 1. Disconnect the power of the Intraoral Scanner (see Disconnecting the scanner on page 27).
  • Page 65: Scanner Body Care

    • Ensure that the scanner tip is detached from the scanner, and the protection cap is put on the scanner when disinfecting the scanner body. Follow the steps below to complete the disinfection: 1. Disconnect the power of the Intraoral Scanner (see Disconnecting the scanner on page27).
  • Page 66 Intraoral ScannerUser Manual 5. Slide the protection cap onto the scanner to prevent damage and dust. CAUTIONS • 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 protection cap.
  • Page 67: Scanner Tip Care

    Intraoral Scanner User Manual Scanner tip care 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 68: Cleaning And High-Level Disinfection

    Intraoral ScannerUser Manual Cleaning and high-level disinfection Follow the steps below to perform cleaning and high-level disinfection: 1. Disconnect the power of the Intraoral Scanner (see Disconnecting the scanner on page27). 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, as illustrated.
  • Page 69 Intraoral Scanner User Manual 7. Repeat the previous step at least two more times. 8. Rinse the tip thoroughly with sterile water for at least 3 minutes. 9. If you notice stains, fingerprints, or smears on the mirror surface, repeat the previous step.
  • Page 70: Cleaning And Steam Sterilization

    Or if you attempt to store the scanner tip with other dental instruments, e.g. a dental instrument tray, ensure that it is thoroughly dry. Cleaning and steam sterilization Follow the steps below to perform cleaning and steam sterilization: 1. Disconnect the power of the Intraoral Scanner (see Disconnecting the scanner on page 27).
  • Page 71: Attaching The Scanner Tip

    Intraoral Scanner User Manual 6. Gently clean the inner and outer sides of the tip using mild pH-neutral soap water and a soft brush for 3 minutes. • When cleaning the inner surface of the tip, insert the soft brush into the tip from both the front and rear ends, and move the brush lightly in tiny circles.
  • Page 72: Scanner Storage

    Intraoral ScannerUser Manual 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. Scanner storage In case you need to transport the device, we strongly recommend that you keep the original packaging after unpacking your Aoralscan.
  • Page 73: Chapter 9: Hardware Specification

    CHAPTER Hardware specification Specifications Table 9-1 Type name Intraoral Scanner Model name Aoralscan 2 Scanner Scan field 11 mm x 11 mm Scan principle Non-contact scanner with the (DLP) structured light Dimension Length: < 280 mm Width: < 40 mm Height: <...
  • Page 74: Environmental Requirements

    Intraoral Scanner User Manual ---------------------------------------------------------------------------------------------------------------------------- Environmental requirements Operating and storage requirements • Operating temperature: 10~40°C • Storage/Transport temperature: -25°C~60°C • Operating altitude: < 3000 M • Storage/Transport/Relative humidity: 30%~75% • MTBF: 14,600 hrs (except DMD/LED) • Air pressure: 700 hPa~1060 hPa...

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