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Related Manuals for Shining 3D MetiSmile
Summary of Contents for Shining 3D MetiSmile
- Page 1 MetiSmile/Datascan Instruction for Use V1.1...
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Page 2: Safety Instructions
⚫ 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 3: Important Safeguards And Warnings
Important Safeguards and Warnings ⚫ Use in a dry room or similar environment with good ventilation, ambient temperature not exceeding 30°C and no flammable or corrosive gases in the air. ⚫ Whether the weather is sunny or rainy, it is necessary to protect against the sun, rain, shock and other protective measure in advance. - Page 4 Note The pictures in this user manual are used for user's understanding, if they do not match with the actual product, the actual product shall prevail.
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Page 5: Table Of Contents
XL/MDR-RD-094 Table of contents Foreword ................................1 INTRODUCTION .............................. 1 BASIC INFORMATION ............................. 2 1) Contraindications ............................5 2) Warnings................................ 5 3) Waste Electrical and Electronic Equipment ....................5 4) Disposal ................................. 5 5) Warranty................................ 6 SAFETY INFORMATION ........................... 7 1) Precautions .............................. - Page 6 XL/MDR-RD-094 9.1. Workflow ..............................21 9.2. Calibration ..............................21 9.3. Create a Project ............................24 9.4. Face Scan ..............................25 9.5. Dentulous Motion Scan ..........................29 9.6. Pre-design ..............................33 9.7. Send Order ..............................35 Product storage/transportation conditions, operating conditions ............35...
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Page 7: Foreword
XL/MDR-RD-094 Introduction MetiSmile is a facial scanning device developed by Shining 3D Tech Co., Ltd. The facial scanner can be applied with the Aoralscan to align the scanned data in order to determine the follow-up treatment plan. Intended Use This is a face scanner that works with the supplied software programs. By performing facial scanning directly, the scanner could acquire and save the 3D images of the face and the mandibular movement trajectory digitally, which can be used for the facial or the oral Computer-aided design (CAD). -
Page 8: Basic Information
Product name: 3D Face scanner Model: MetiSmile Name, residence, contact information and after-sales service of the manufacturer 2） Manufacturer name: Shining 3D Tech Co., Ltd. Production Address: No. 1398, Xiangbin Road, Wenyan, Xiaoshan, Hangzhou, Zhejiang, China, 311258 Contact Information 3）... - Page 9 USB flash drive, and the software release version is 1. Introduction Calibration Plate Markers Certificate ＆ Warranty Quick Guide Carrying Case Protective shell USB 3.0 Repeater Power Adapter Scanner body Tripod Cable MetiSmile/Datascan_IFU_V1.1...
- Page 10 The users of this scanner and software are responsible for image quality and diagnosis. They should ensure that the inspection data is being used for the analysis and diagnosis only, and furthermore the data is sufficient both spatially and temporally for the measurement approach being used. MetiSmile/Datascan_IFU_V1.1...
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Page 11: Contraindications
All electrical and electronic devices must be disposed of separately from your other household waste in order to promote reuse, recycling and other forms of recovery, to prevent any potential adverse effects of hazardous substances on the environment and human health, and also to reduce the amount of waste in landfill. This includes MetiSmile/Datascan_IFU_V1.1... -
Page 12: Warranty
For specific information on disposal of your device and the packaging, contact your local distributor or service provider. 5) Warranty The warranty is void if unauthorized personnel perform service or maintenance on the set of the scanner. To ensure correct product performance and to obtain warranty service, contact technical support. MetiSmile/Datascan_IFU_V1.1... -
Page 13: 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 14: Labels And Symbols
Indicates the manufacturer's serial number so that a specific medical device can be identified. Device fulfills the requirements of the European Regulation 2017/745 given on the EU Declaration of Conformity. Indicate the item is a medical device. Class 1 laser product. MetiSmile/Datascan_IFU_V1.1... -
Page 15: Compliance
Standard: Electromagnetic 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 MetiSmile/Datascan_IFU_V1.1... -
Page 16: Classification
⚫ With the exception of cables sold by the manufacturer of scanner as spare parts for internal components, the use of accessories and cables other than those specified may result in an increase in transmission MetiSmile/Datascan_IFU_V1.1... - Page 17 Floors should be wood, concrete or ±8 kV contact ±8 kV contact Electrostatic ceramic tile. If floors are covered with discharge (ESD) ±2，±4，±8，±15 kV air ±2，±4，±8，±15 kV air IEC 61000-4-2 synthetic material, a relative humidity of at least 30% is recommended. MetiSmile/Datascan_IFU_V1.1...
- Page 18 The purchaser or user of scanner should ensure that it is used in this electromagnetic environment: Electromagnetic environment – Immunity test IEC 60601 test levels Compliance level guidance MetiSmile/Datascan_IFU_V1.1...
- Page 19 The purchaser or user of scanner should ensure that it is used in this electromagnetic environment: Electromagnetic environment – Immunity test IEC 60601 test levels Compliance level guidance MetiSmile/Datascan_IFU_V1.1...
- Page 20 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = transmitter (W) 2.3 √P d = 1.2 √P d = 1.2 √P 0.01 0.12 0.12 0.23 0.38 0.38 0.73 MetiSmile/Datascan_IFU_V1.1...
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Page 21: 9）Biological Safety
Meets biological criteria: ISO10993-5: 2009 (Biological evaluation of medical devices — Part 5:Tests for in vitro cytotoxicity); ISO10993-10: 2021 (Biological evaluation of medical devices — Part 10: Tests for skin sensitization); ISO10993-23: 2021 (Biological evaluation of medical devices — Part 10: Tests for irritation) MetiSmile/Datascan_IFU_V1.1... -
Page 22: 10） Laser Protection
Ensure that you have completely disconnected the power supply and all connections from the scanner. ⚫ Using detergent, disinfection solutions or wipes, sterilization procedures other than those specified in the Manual may damage the product and void your warranty. ⚫ To prevent cross-contamination, disinfection must be correctly performed after each use. MetiSmile/Datascan_IFU_V1.1... -
Page 23: Scanner Storage
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. Daily and Long-term Storage 2） Before storing the scanner, make sure the scanner is thoroughly dry. MetiSmile/Datascan_IFU_V1.1... -
Page 24: Specifications
Texture: 2448 × 2048 ≤ 50μm Accuracy Black and White: 41.3° Texture：49.3° PLY，OBJ，STL Output Format White LED color temperature 5500K 215mm × 50mm × 75mm Dimension Weight 800g Input：AC100 ㅡ 220V；FR 50Hz or 60Hz；1.5A Power Supply Output: DC 12V/7.0A Overview MetiSmile/Datascan_IFU_V1.1... -
Page 25: Recommended Pc Configuration
Intel® Core™ i7-8700 or above Minimum ： 16GB RAM Memory Recommend ： 32GB RAM Minimum ： 256GB Hard Disk Recommend ： 2TB Drive NVIDIA RTX 2060 or above Windows 10/11 Professional (64-bit) Ports More than 2 type-A USB 3.0 (or higher) ports MetiSmile/Datascan_IFU_V1.1... -
Page 26: Connect The Scanner
One interface of repeater USB3.0 is connected to the scanner, and the other interface connects to other scanner. The tripod can be raised to 80cm, and it is recommended to raise the tripod to about 45cm, which is more stable. MetiSmile/Datascan_IFU_V1.1... -
Page 27: Operation
Under these circumstances, we recommend that you shall execute the calibration for the scanner to ensure the accuracy of scanned data: ● The initial setup of the scanner is completed. ● The scanner has been used for a period of time (e.g. 2 weeks). MetiSmile/Datascan_IFU_V1.1... -
Page 28: Camera Calibration
The calibration file name is matched with the number on the calibration plate back. If there is no matching file, you can click “Download” or “Import the calibration file” to get the file that matches the calibration plate. Place and secure the scanner. Position the calibration plates as directed by the guide. MetiSmile/Datascan_IFU_V1.1... - Page 29 Note： After a successful calibration, it will automatically enter the plane calibration. Face the whiteboard with the camera. MetiSmile/Datascan_IFU_V1.1...
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Page 30: Create A Project
Hold the calibration panel and move it forward and backward at a constant speed until all the distance bars is fully filled with green. After data collection is completed, the interface prompts information of successful calibration. 9.3. Create a Project Before scanning objects, please create a new order. Note： Please calibrate before creating an order. Step MetiSmile/Datascan_IFU_V1.1... -
Page 31: Face Scan
Custom face scanned data could be used for doctor's diagnosis or other purposes. The scanned data needs to be aligned with the face scanned data. Scanning methods include handheld and fixed modes. Preparation before scanning: Before collecting data, take off your glasses, tie up your hair, and keep your mouth open and smile. MetiSmile/Datascan_IFU_V1.1... -
Page 32: Handheld Mode
Scan the facial data at a constant speed. Click the button of the scanner or "Start Scan" on the interface. Scan the facial data at a constant speed. In order to better collect facial information, you need to wear mouth prop for collect more scan data. MetiSmile/Datascan_IFU_V1.1... - Page 33 Click "Confirm" to save the edit and return to the scanning interface. Calculate and view the alignment effect by the colour bar. When picture of teeth is shown more in green, it indicates that the alignment effect is better. MetiSmile/Datascan_IFU_V1.1...
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Page 34: Fixed Mode
Turn the head at a constant speed and a voice prompt will remind that the collection has been completed. Note： If the oral data has been imported, the oral data and facial data will be aligned automatically; if there is no oral data, click "Import" and select the corresponding oral data. MetiSmile/Datascan_IFU_V1.1... -
Page 35: Dentulous Motion Scan
⚫ Paste the markers on the teeth (the number of markers ≥ 3), and ensure that the markers are arranged irregularly. ⚫ Do not arrange a straight line or approximate a straight line (such as obtuse angle>150°) ⚫ Do not arrange in an isosceles triangle. MetiSmile/Datascan_IFU_V1.1... - Page 36 10. After completing the collection of markers, the interface will pop up a message for the completion of collection. MetiSmile/Datascan_IFU_V1.1...
- Page 37 When this button is clicked, it enters the edit interface to select Edit the data to be deleted. Click to delete the smaller independent model data that are not Remove isolated data connected to the main model data. Help delete unrelated model data quickly. MetiSmile/Datascan_IFU_V1.1...
- Page 38 Alignment mode supports automatic and manual mode. If the alignment effect is not satisfactory, you can choose manual . When creating an order, upload intra-oral scanning data to align with facial scanning data. Double click on the two models to select three corresponding points to align. MetiSmile/Datascan_IFU_V1.1...
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Page 39: Pre-Design
9.6. Pre-design 9.6.1. View Edit Support preview the different angles of the model and optimized scan data. In the right operation bar, you can edit the scanned data. MetiSmile/Datascan_IFU_V1.1... - Page 40 9.6.3. Orthodontic Simulation Simulate orthodontic treatment solution, and view the expected effect according to different treatment solutions. Click on the pre-design interface to enter the orthodontic simulation interface. Orthodontic simulation can be divided into tooth segmentation, modeling and tooth setup. Note: MetiSmile/Datascan_IFU_V1.1...
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Page 41: Send Order
You can click Setup to enter setup interface if the segmentation is completed. 9.7. Send Order When data processing is completed, click "Send" directly, or select "Target" to upload to the cloud platform. Product storage/transportation conditions, operating conditions. 10． Operating and storage requirements Description MetiSmile/Datascan_IFU_V1.1... - Page 42 XL/MDR-RD-094 MetiSmile/Datascan_IFU_V1.1...
- Page 43 XL/MDR-RD-036 A/1 Shining 3D Tech Co., Ltd. 3D Face Scanner MetiSmile/Datascan Packaging Description Add: No.1398, Xiangbin Road, Wenyan, Xiaoshan | 311258 Hangzhou | China Tel: +86 571 82879352 Fax: +86 571 82999510 Web: www.shining3d.com...
- Page 44 XL/MDR-RD-036 A/1 Shining 3D Tech Co., Ltd. 1. 3D Face Scanner Packaging Description Item Name Material Size Photo 510mm×390mm Upper pad ×15mm 90mm×12mm Logo —— ×0.5mm Outer 510mm×390mm Inner pad packing ×145mm Carton Corrugated 522mm×402mm ×175mm Cardboard EVA + Package 445mm×325mm...
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Page 45: Exterior Appearance
XL/MDR-RD-036 A/1 Shining 3D Tech Co., Ltd. 2. Package A. Exterior appearance Front Side B. Internal planning Add: No.1398, Xiangbin Road, Wenyan, Xiaoshan | 311258 Hangzhou | China Tel: +86 571 82879352 Fax: +86 571 82999510 Web: www.shining3d.com... - Page 46 XL/MDR-RD-036 A/1 Shining 3D Tech Co., Ltd. 3. Labers position On scanner On carton box Bottom side of scanner Front side of carton box 4. Documents in the package（Envelope） A: Scanner Outer Kit Packing List (2 pieces ) B: Disinfection Guide for Scanner Tips (2 pieces )
- Page 47 Shining 3D Tech Co., Ltd. Metismile/Datascan 3D Face Scanner Physician Labels List *Note：The QR codes mentioned in the document are for illustrative purposes only. The manufacture date of product symbol will be on the QR code like the first figure shows.
- Page 48 Shining 3D Tech Co., Ltd. 2. Label on repeater Metismile/Datascan 3. Label on Package Metismile/Datascan Add: No.1398, Xiangbin Road, Wenyan, Xiaoshan | 311258 Hangzhou | China Tel: +86 571 82879352 Fax: +86 571 82999510 Web: www.shining3ddental.com...
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