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AlliedStar AS 200E Instructions Manual

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AS 200E
Instructions

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Summary of Contents for AlliedStar AS 200E

  • Page 1 AS 200E Instructions...

  • Page 2: Table Of Contents

    Contents Labels and Symbols–4 EN/English–7 Notice ....................7 Description ..................8 Setting Up the Scanner ..............14 Getting Started .................. 19 Safety Guide ..................23 Troubleshooting ................30 Regulatory Information..............32 Technical Specifications ..............39...
  • Page 3 Contact Information–180...

  • Page 4: Labels And Symbols

    Labels and Symbols EN Type BF applied part DE Anwendungsteil vom Typ BF ES Componente aplicado de tipo BF FR Partie appliquée de type BF IT Parte applicata di tipo BF EN Separate collection for waste electric and electronic equipment (WEEE) is required.
  • Page 5 EN Direct current DE Gleichstrom ES Corriente continua FR Courant continu IT Corrente continua EN Sterilizable in a steam sterilizer (autoclave) at 134°C DE Sterilisierbar in einem Dampfsterilisator (Autoklav) bei 134°C ES Esterilizable en esterilizador de vapor (autoclave) a 134 °C FR Stérilisable dans un stérilisateur à...
  • Page 6 EN This device complies with Part 15 of the FCC Rules DE Dieses Gerät entspricht Teil 15 der FCC-Vorschriften ES Este dispositivo cumple con la parte 15 de las normas de la FCC FR Cet appareil est conforme à la partie 15 des règles de la FCC. IT Questo dispositivo è...

  • Page 7: English-7

    U.S. Federal law restricts this device to sale by or on the order of a dentist. If any serious incident occurs in relation to the device, the user must report it to Alliedstar and to the competent authority of its Member State in the European Union.

  • Page 8: Description

    » Description Intended use The AS 200E Intraoral Scanner (herein after referred as ‘scanner’) is a digital optical scanning device used to obtain digital impressions of hard and soft tissues such as teeth, gums, and mucous membrane by means of oral scanning, for oral restoration and orthodontic treatment of malocclusion.
  • Page 9 Description [1] Handpiece [2] Scanner Tip [3] Scan Button • Press once to start scanning, press again to stop scanning [4] Mode Indicator Upper jaw scan mode Lower jaw scan mode Buccal bite registration mode [5] Mode Switch Button • Press this button to switch between different modes [6] Status Indicator •...

  • Page 10: Computer System Requirements

    Description [10] USB Cable (1m length) Computer System Requirements For the computer system requirements, refer to the ‘Technical Specifications’ section WARNING: It is MANDATORY to check that your computer system configuration is compatible with the computer system requirements for the accompanying software. Charging the Battery A fully charged battery can support up to 2 hours of scan time.
  • Page 11 Turn the battery cover with a coin to unlock. • Take out the low battery and insert a charged one. WARNING: Please use the battery specified by Alliedstar (Li-18650-3.6V 3500mAh- PCM-Cap). • Close the battery cover by turning it to lock.

  • Page 12: Wireless Connection

    Description NOTE: Please fully charge the battery before use. Wireless Connection The scanner connects to the software through a wireless connection. Before using the scanner, a compatible wireless adapter needs to be connected to the computer that runs the software. NOTE: Expand the wireless adapter to maximize the network signal strength.
  • Page 13 Description Indicates a wireless scanner Indicates a wired scanner Charging Holder Overview Place the scanner in the Charging Holder when you are not using it. NOTE: The scanner will automatically shut down if it is idle for more than 3 minutes. If you need to use it again, press any button on the scanner, or take it out of the Charging Holder.

  • Page 14: Setting Up The Scanner

    Setting Up the Scanner » Setting Up the Scanner Setting Up the Scanner To set up the scanner, follow these steps: • Visit https://support.allied-star.com/download and download the installation file and instructions according to the product model. • Double-click the software installation file. •...
  • Page 15 Setting Up the Scanner • Insert the charger with the connected charging cable into the base. • Insert the charging cable into the holder bracket. • Pass the other end of the cable through the hole reserved on the base.
  • Page 16 Setting Up the Scanner • Insert the scanner into the Charging Holder. Installing the Wall Mount Charging Holder To mount the Charging Holder on the wall, follow these steps: • Select an area that you can access easily. • Insert the screws through the holes in the holder bracket to affix it to a solid surface.
  • Page 17 Setting Up the Scanner • Insert one end of the charging cable into the bottom of the charger. • Insert the Charging Holder into the holder bracket.
  • Page 18 Setting Up the Scanner • Insert the scanner into the Charging Holder. CAUTION: If the Charging Holder is not properly installed, there is a risk that the Charging Holder can fall off the wall, resulting in damage to the scanner.

  • Page 19: Getting Started

    Getting Started » Getting Started Accessing the software user interface To access the software user interface, follow these steps: • Launch the software, the software will automatically pop up the login window. • If you don’t have an account, click the Sign up button to register the organization, and complete the email verification.

  • Page 20: Preparing The Scanner

    Getting Started If the scanner is not activated, the scanner activation dialog will be displayed. Follow the instructions on the screen to complete the scanner activation. • Click the Option menu button and select Preferences. • Customize the configuration options. •...

  • Page 21: Starting Scanning

    Getting Started CAUTION: Scanner Tips are shipped non-sterile. You must sterilize them before the first use. CAUTION: Avoid any liquid from leaking into the air outlet near the Scanner Tip mount or the air inlet at the rear of the Handpiece, otherwise the Handpiece may be damaged. To prepare the scanner, follow these steps: •...
  • Page 22 Getting Started Scanning Approach The recommended scanning method is to start with a molar, since it has greater details for easier identification. Change the scanning angle to less than 60 degrees during scanning to allow the surfaces to overlap, if the overlap is too small, the alignment may be lost. Scanning Protocol The recommended scanning protocol consisting of 3 sweeps: occlusal, lingual and buccal to ensure good data coverage of all surfaces.

  • Page 23: Safety Guide

    CAUTION: All known residual risks, contraindications, or undesirable side effects are listed in this document. If any serious incident occurs in relation to the device, you must report it to Alliedstar and to the competent authority of your Member State in the European Union. WARNING Scanner •...
  • Page 24 • DO NOT remove the cover of any scanner components. The scanner contains no user- serviceable parts. For any repairs, contact a qualified Alliedstar service technician. • DO NOT replace the cables provided with the scanner with other cables. Doing so may damage the scanner and adversely affect the safety protection and EMC performance of the scanner.
  • Page 25 Safety Guide be hazardous. • See the installation guide for your computer for information about the data processing system, computer, and screen. Leave a sufficient amount of clear space around the computer to ensure that it is properly ventilated. • Position the screen to avoid light reflections from internal or external lighting for maximum image quality and visual comfort.
  • Page 26 Safety Guide Disposal This equipment contains certain materials and chemical compounds incidental to the manufacture of electrical and electronic equipment, and improper “end-of-life” disposal of such equipment can result in environmental contamination. Therefore, this equipment should not be disposed of as ordinary household waste but should instead be delivered to a designated electrical and electronic waste disposal or recycling center.
  • Page 27 Safety Guide • You must wear gloves while cleaning and disinfecting the scanner. • The scanner must be disinfected with a recommended intermediate-level disinfectant solution with tuberculocidal activity between patients. • DO NOT use a disinfectant containing phenolics or iodophors; doing so will damage the surface coating of the scanner.
  • Page 28 Safety Guide WARNING: Do not rinse. • Allow to air dry. • After the scanner has dried, use a clean, lint-free cloth dampened with water to remove residual disinfectant from the surface of the scanner. Clean and Sterilize the Scanner Tip WARNING •...

  • Page 29: Precautions Before Use

    Safety Guide » For TP202 and TP203, exposure time should exceed 3 minutes. » For TP202 and TP203, exposure time should not exceed 6 minutes. Precautions before use Perform the following activities on your product and accessories before use. Visually Inspecting the Scanner for Damage Visually inspect the scanner for damage or signs of deterioration by doing the following: »...

  • Page 30: Troubleshooting

    Troubleshooting » Troubleshooting Problem Description Action There is mismatching Remove mismatched data and excessive tissue using the Cut and overlap on the 3D tool and rescan. model. After bite registration, there is a gap or • Set “Bite adjustment” to “Avoid intersections” in Preferences. intersection between •...
  • Page 31 Troubleshooting The scanner does not cast light, and a static preview image is Close the software, and then launch the software again. displayed in the video preview screen. Scanner is not shown Reset the network in the scanner. To do so, while the Status in the ‘Scanner List’...

  • Page 32: Regulatory Information

    Regulatory Information » Regulatory Information Regulatory Information The device complies with the following regulations: MDR: (EU) 2017/745 Medical Device Regulation, Cass I following the Rule 5. FDA Center for Devices & Radiological Health CDRH - Title 21 CFR 872.3661 (USA). Medical Devices Regulations (Canada).
  • Page 33 Regulatory Information EN / IEC 62304: Medical device software - Software life cycle Processes EN ISO 10993: Biological evaluation of medical devices ISO 14971: Medical devices - Application of risk management to medical devices EN / ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements EN ISO 20417: Medical devices —...
  • Page 34 Regulatory Information the EMC information provided in this documentation. Other equipment can interfere with communications with the device, even if the equipment complies with CISPR emissions requirements. WARNING: Portable and mobile 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 DEVICE, including cables specified by the manufacturer.

  • Page 35: Guidance And Manufacturer's Declaration

    Regulatory Information —Increase the separation between the equipment and receiver. —Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. —Consult the dealer or an experienced radio/ TV technician for help. Guidance and Manufacturer’s Declaration Guidance and Manufacturer’s Declaration - Electromagnetic Emission The device is intended for use in the electromagnetic environment specified below.
  • Page 36 Regulatory Information Electromagnetic IEC 60601 Test Immunity Test Compliance Level Environment - Level Guidance Floors should be wood, concrete, or ceramic tile. If floors Electrostatic ±8 kV contact ±8 kV contact are covered with discharge (ESD) ±15 kV air ±15 kV air synthetic material, IEC 61000-4-2 the relative humidity...

  • Page 37: Other Equipment

    Regulatory Information Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for Equipment and Systems (from RF wireless communication equipment) For the immunity to proximity fields from RF wireless communications equipment, the DEVICE is compliant with the test levels specified below, according to IEC60601-1-2 Table 9. The customer or user of the DEVICE should assure that it is used in such an environment.
  • Page 38 Regulatory Information should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify normal operation.

  • Page 39: Technical Specifications

    Technical Specifications » Technical Specifications Model AS 200E Technical Specifications Components Technical Specifications Scanner (including battery, without Scanner Tip): 245 g Weight Tip Large - Sterilization (TP202): 13g Tip Small - Sterilization (TP203): 12g Color 3D full color USB wireless Card Port USB 3.0...

  • Page 40: Environmental Requirements

    Technical Specifications Environmental Requirements Components Environmental Requirements Operating Temperature 15°C ~ 30°C Transport and Storage Temperature -10°C ~ 50°C Operating Relative Humidity 10% ~ 65% RH Transportation and Storage Relative Humidity 10% ~ 95% RH Operating Atmospheric Pressure 70 ~ 106 KPa Transportation and Storage Atmospheric 60 ~ 106 KPa Pressure...

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