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Summary of Contents for Shining 3D Aoralscan Elite Wireless
- Page 1 Aoralscan Elite Wireless Instructions for Use Version: V1.0 © 2024 SHINING 3D, All rights reserved.
- Page 2 The Declaration of Intellectual Property and Disclaimer Thank you for using the products of SHINING 3D TECH CO., LTD.(hereinafter referred to as the "SHINING 3D”). Before you use the products, please carefully read and understand this declaration. Once you use this product, it means that you fully accept this statement and promise to comply with the relevant regulations.
- Page 3 3. SHINING 3D does not guarantee the applicability of the outcomes of your use of the products, and you are responsible for verifying the quality and functionality of the outcomes. You should check and verify thoroughly that any outcomes meet your requirements before using them, for which you bear full responsibility.
- Page 4 4.1 Notes of connection and disconnection 4.2 Attach the scanner tip 4.3 Detach the scanner tip 4.4 Connect the scanner 4.5 Disconnect the scanner 4.6 Calibration 4.7 Replace and Charge the Battery Aoralscan Elite Wireless Instructions for Use V1.0 4 / 54...
- Page 5 7.1 Electrical safety 7.2 EMC 7.3 Biological safety 7.4 Laser protection 7.5 Explosion prevention 8. Specifications 8.1 Specifications of the scanner 8.2 Specifications of the environment Appendix FCC Compliance Statement ISED Aoralscan Elite Wireless Instructions for Use V1.0 5 / 54...
- Page 6 SHINING 3D’s EU representative Lotus NL B.V. Address: Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. Telephone: +31644168999 Email: peter@lotusnl.com EU importer Shining3D Technology GmbH Address: Breitwiesenstraße 28, 70565 Stuttgart Germany Aoralscan Elite Wireless Instructions for Use V1.0 6 / 54...
- Page 7 General Requirements: It should be driven by software installed in the Scanner or by software specified by the manufacturer for digitizing and presenting the surface of the patient's teeth and adjacent soft tissues. Software functions Aoralscan Elite Wireless Instructions for Use V1.0 7 / 54...
- Page 8 Use NVIDIA graphics cards to get the best scan efficiency. Do not insert wireless USB network card in the computer. USB wireless network card will cause USB bandwidth occupation, limiting camera performance. V. Production date and life time Aoralscan Elite Wireless Instructions for Use V1.0 8 / 54...
- Page 9 Do not use the scanner on patients using the cardiac pacemaker or ICD in order to avoid possible interference. Do not attempt to disassemble, repair, or modify the scanner. If necessary, please contact the manufacturer or its designated distributor. Aoralscan Elite Wireless Instructions for Use V1.0 9 / 54...
- Page 10 To identify a type BF applied part complying with IEC 60601-1. To indicate that the contents of the transport package are fragile and the package shall be handled with care. Aoralscan Elite Wireless Instructions for Use V1.0 10 / 54...
- Page 11 To identify the manufacturer's serial number, for example on a medical device or its packaging. The serial number shall be placed adjacent to the symbol. To indicate conformity with local laws and regulations within the European Economic Area. Aoralscan Elite Wireless Instructions for Use V1.0 11 / 54...
- Page 12 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 - Part 1: General requirements". Aoralscan Elite Wireless Instructions for Use V1.0 12 / 54...
- Page 13 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. Aoralscan Elite Wireless Instructions for Use V1.0 13 / 54...
- Page 14 Scanner tips(big tip, standard tips, and mini tip) Dust cap USB flash drive Dust cover Charging case Quick guide and Disinfection guides certificate Package Note: The number of scanner tips is selectable. Aoralscan Elite Wireless Instructions for Use V1.0 14 / 54...
- Page 15 Please do not use accessories, peripherals, or cables not provided with the product or recommended by SHINING 3D Tech Co., Ltd. Otherwise, it may void the warranty, lead to electrical leakage, threaten the safety of the grounding scheme, and decrease the scanner's resistance to external EMI/EMC interference.
- Page 16 4. Fast flashing green: The battery power is 0%. 5. If the indicator goes out: The scanner is shut down. The battery is not inserted into the scanner. Scanner cradle Aoralscan Elite Wireless Instructions for Use V1.0 16 / 54...
- Page 17 When the scanner is placed and enters sleeping mode on the cradle which is powered up, the scanner tip will be heated up for 10 minutes. Aoralscan Elite Wireless Instructions for Use V1.0 17 / 54...
- Page 18 Do not strike, throw or subject the battery to sever physical shock. Do not pierce the battery casing with a nail or other sharp objects, break it open with a hammer, or step on it. Aoralscan Elite Wireless Instructions for Use V1.0 18 / 54...
- Page 19 I/O ports At least 1 USB Type-C port, 1 type-A USB 3.0 (or higher) port Note: Your PC shall meet the safety requirements of IEC 60950-1, IEC 62368-1/GB 4943.1. Software Installation Aoralscan Elite Wireless Instructions for Use V1.0 19 / 54...
- Page 20 Before making changes to the network, controlled local entities in dental clinics or dental laboratories should identify, analyze, evaluate, and control potential risks, and operate in accordance with relevant network security regulations. Aoralscan Elite Wireless Instructions for Use V1.0 20 / 54...
- Page 21 Follow the steps below to complete the disinfection: 1. Disconnect the power of the scanner (see more details in Connection and disconnection). Aoralscan Elite Wireless Instructions for Use V1.0 21 / 54...
- Page 22 High-level disinfection and steam sterilization must NOT be combined. Warning: Before cleaning and disinfection/sterilization, please wear clean surgical gloves and goggles. There are two effective and approved methods: Cleaning and high-level disinfection. Cleaning and high temperature autoclave sterilization. Aoralscan Elite Wireless Instructions for Use V1.0 22 / 54...
- Page 23 6. If using the scanner tip immediately is required, reconnect it; if not, store it with other dental instruments, and make sure it is totally dry. High temperature autoclave sterilization steps Aoralscan Elite Wireless Instructions for Use V1.0 23 / 54...
- Page 24 Avoid splashing water into the charging case to protect it. Despite a careful maintenance and a normal usage, the lithium-ion battery's capacity still decreases with its aging. It has nothing to do with the quality of the product. Aoralscan Elite Wireless Instructions for Use V1.0 24 / 54...
- Page 25 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. Aoralscan Elite Wireless Instructions for Use V1.0 25 / 54...
- Page 26 2. Cap the scanner with the scanner tip and ensure it's firmly attached. 3. Connect the cradle with the cable and plug it into a Type-C port on the computer. 4. Launch the software. Aoralscan Elite Wireless Instructions for Use V1.0 26 / 54...
- Page 27 Store the detached tip in a safe place, e.g. a dental tray, for future use. 3. Connect the calibrator and your computer with the supplied USB 3.0 cable. 4. Gently slide the calibrator onto the front end of the scanner. Aoralscan Elite Wireless Instructions for Use V1.0 27 / 54...
- Page 28 Under proper maintenance and normal use, the battery life is approximately 3 years, but as the lithium-ion battery ages, the capacity of the battery will decrease. When replacing the battery, make sure the scanner is turned off. Do not remove the battery or install/replace an unsuitable battery. Aoralscan Elite Wireless Instructions for Use V1.0 28 / 54...
- Page 29 Please place it in a safe place where children cannot touch it. Store in an environment free of dust, liquid, metal debris, etc. Please store in a clean and dry environment. Aoralscan Elite Wireless Instructions for Use V1.0 29 / 54...
- Page 30 Ensure the scanner is free of problems like broken parts, loose connection or abrasion. If so, contact the after- sales service. To avoid condensation on the lens of the tip when scanning, the scanner tip must have been heated up. Note: Aoralscan Elite Wireless Instructions for Use V1.0 30 / 54...
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