Table of Contents
Advertisement
Advertisement
Table of Contents
Related Manuals for AlliedStar AS 200E
Summary of Contents for AlliedStar AS 200E
- Page 3 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 4: Table Of Contents
Guidance and Manufacturer’s Declaration .................... 15 Accessories ............................. 17 Other Equipment ............................ 17 Technical Specification ....................18 Model ..............................18 AS 200E Technical Specifications ......................18 AS 200E Environmental Requirements ....................19 Contact Information ..................... 20 Manufacturer ............................20 Authorized Representatives ........................20... -
Page 5: Safety Information
Safety Information Intended use The AS 200E 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 6: Conventions In This Manual
IMPORTANT: All known residual risks, contraindications, or undesirable side effects are listed in this manual. 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. Safety Information... - Page 7 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 8 Additional multiple outlet strips or extension cords should not be connected to the system. The maximum temperature of the applied part may reach to 43 °C; to avoid overheating, do not use it for extended periods. To power off the scanner, push the power button for 3 seconds. To isolate the holder from power supply, unplug the USB connector from the USB port.
- Page 9 Dispose of the scanner tips according to standard operating procedures or local regulations for the disposal of contaminated medical waste. For additional scanner tips, contact your dealer. AS 200E User Manual: Safety, Regulatory and Technical Specification...
-
Page 10: Cleaning, Disinfecting, Sterilizing
Cleaning, Disinfecting, Sterilizing Perform the following maintenance activities on your scanner and accessories regularly. To ensure maximum hygienic safety for the patient, carefully follow the instructions to prepare the scanner for use. To ensure maximum hygienic safety for the patient and to minimize the risk of cross-contamination, carefully perform the following maintenance activities on your scanner and accessories. - Page 11 Thoroughly wipe all surfaces of the scanner, DO NOT allow liquid to enter through the gap, air outlet, or pin holes. WARNING: Do not rinse. Allow to air dry. AS 200E User Manual: Safety, Regulatory and Technical Specification...
- Page 12 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 Tip WARNINGS Wear gloves when handling a contaminated scanner tip. Read and follow the warnings and personal protection instructions provided in the manufacturer’s SDS for the detergent used to clean the scanner tip.
- Page 13 Important: For TP202 and TP203, exposure temperature should be set as 134°C. Important: For TP202 and TP203, exposure time should exceed 3 minutes. Important: For TP202 and TP203, exposure time should not exceed 6 minutes. AS 200E User Manual: Safety, Regulatory and Technical Specification...
-
Page 14: Precautions Before Use
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: Inspect the scanner's lens window. ... -
Page 15: Regulatory Information
General Safety and Performance Requirements (GSPR) of all EU related medical instruments, and the CE mark is also a legal requirement for medical devices to list in the EU market. AS 200E User Manual: Safety, Regulatory and Technical Specification... -
Page 16: Regulatory Information
Regulatory Information The AS 200E 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). -
Page 17: Classification In Accordance With En/Iec 60601-1
Degree of protection against electric shock: Type BF Applied Part Mode of operation: Continuous operation Flammable anesthetics: Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide. AS 200E User Manual: Safety, Regulatory and Technical Specification... -
Page 18: Conformity With En/Iec 60601-1-2
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 AS 200E, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. -
Page 19: Guidance And Manufacturer's Declaration
Systems (from Non-RF wireless communication equipment） The AS 200E is intended for use in the electromagnetic environment specified below (IEC 60601-1-2 Table 4). The customer or the user of the AS 200E should assure that it is used in such an environment. Immunity Test... - Page 20 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AS 200E is used exceeds the applicable RF compliance level above, the AS 200E should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the AS 200E.
-
Page 21: Accessories
WARNING: Use of this equipment adjacent to or stacked with other equipment 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. AS 200E User Manual: Safety, Regulatory and Technical Specification... -
Page 22: Technical Specification
Technical Specification Model AS 200E AS 200E Technical Specifications Components Technical Specifications Weight Scanner (including battery, without tip): 245 g Tip Large - Sterilization (TP202): 13g Tip Small - Sterilization (TP203): 12g Color 3D full color USB wireless Card Port USB 3.0... -
Page 23: As 200E Environmental Requirements
Operating Relative Humidity 10% ~ 65% RH Transportation and Storage Relative Humidity 10% ~ 95% RH Operating Atmospheric Pressure 70 ~ 106 KPa Transportation and Storage Atmospheric Pressure 60 ~ 106 KPa AS 200E User Manual: Safety, Regulatory and Technical Specification... -
Page 24: Contact Information
Contact Information Manufacturer Alliedstar Medical Equipment Co., Ltd. No.1-4, Floor 3, Unit 2, Building 3, No.222, West third section, Waihuan Road, Yanjiang District, Ziyang, 641300, Sichuan, P.R. China E-mail: support@allied-star.com Authorized Representatives Authorized Representative in the European Community SUNGO Europe B.V. - Page 26 Contact Information...
Need help?
Do you have a question about the AS 200E and is the answer not in the manual?
Questions and answers