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Safety, Regulatory and Technical Specifications User Guide

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Summary of Contents for Carestream DENTAL RVG 142

  • Page 1 Safety, Regulatory and Technical Specifications User Guide...
  • Page 2 N ot ic e The Regulatory Information & Technical Specification User Guide for RVG 142, RVG 5200 and RVG 6200 includes information on the safety instructions, regulatory information and the technical specifications of the device. We recommend that you thoroughly familiarize yourself with this Guide to make the most effective use of your system.
  • Page 3: Table Of Contents

    Factory ......................... - 15 - Manufacturer ....................... - 15 - Model ........................... - 15 - RVG 142, RVG 5200 and RVG 6200 Technical Specifications ....... - 16 - RVG Connect Technical Specification ..............- 17 - Minimum Computer System Requirements ............. - 18 - Imaging Performance Information ................
  • Page 4: Safety Information

    X-ray imaging of the dento-maxillofacial area. RVG 142, RVG 5200 and RVG 6200 transmit an acquired image to a computer using a USB cable. To do so, they require additional components such as conventional extra-oral X-ray source and imaging software.
  • Page 5: Warning And Safety Instructions

    Computer • RVG 5200 or RVG 6200 or RVG 142 shall be supplied by Low Voltage-Low Power (<15W) source separated from the mains by DI/RI Isolation (Double isolation / Reinforced isolation). The USB port of a computer or the hub is separated from the mains by DI/RI Isolation.
  • Page 6: Hygiene And Disinfection

    5. Dry with compressed air or hygienic disposable cloth. 6. Visually inspect the RVG sensor holder for residual debris. Repeat steps 1 to 5 if you see residual debris. RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 7: Cleaning The Rvg Connect Unit

    Cleaning the RVG Connect Unit The RVG Connect unit must be cleaned with disposable disinfecting wipes with intermediate-level hospital disinfectant with label claims of tuberculocidal activity. RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 8: Marking And Labeling Symbols

    Contact your local sales representative for additional information on the collection and recovery programs available for this product. Warning Refer to instruction manual/booklet Date of Manufacture. Manufacturer’s address. RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 9: Label Locations

    Date: 2019/02/16 N° EBJL0003 EBJL0003 Figure 3: RVG 142 product label Figure 4 RVG Connect unit label RVG Connect Carestream Dental, LLC DDJI0020 Input: 48-56V 0.25A DDJI0020 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 10: Regulatory Information

    Medical Electrical Equipment – Part 1: General CAN/CSA C22.2 N°60601-1 Requirements for basic safety and essential performance Medical Electrical Equipment – Part 1: General ANSI/AAMI ES60601-1 Requirements for basic safety and essential performance RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 11 • Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). • RVG 142, RVG 5200 and RVG 6200 are intended to be used in a professional healthcare facility environment. • RVG 142, RVG 5200 and RVG 6200 must be installed and put into service according to the EMC information provided in this document.
  • Page 12 RVG 142, RVG 5200 and RVG 6200 are intended for use in the electromagnetic environment specified below. The customer or the user of RVG 142, RVG 5200 and RVG 6200 should assure that it is used in such an environment.
  • Page 13 RVG 142, RVG 5200 and RVG 6200 are intended for use in the electromagnetic environment specified below. The customer or the user of RVG 142, RVG 5200 and RVG 6200 should assure that they are used in such an environment.
  • Page 14: Compliance With International Regulations

    RVG 142, RVG 5200 and RVG 6200 are intended for use in the electromagnetic environment specified below. The customer or the user of RVG 142, RVG 5200 and RVG 6200 should assure that it is used in such an environment.
  • Page 15: Technical Specification

    Technical Specification Factory TROPHY 4, rue F. Pelloutier, Croissy-Beaubourg 77435 Marne la Vallée Cedex 2, France Manufacturer Model RVG 5200 RVG 6200 RVG 142 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 16: Rvg 142, Rvg 5200 And Rvg 6200 Technical Specifications

    Input voltage 5V DC (USB interface) USB Interface USB 2.0 high Speed USB Connector Plug Type A *Optical fiber: Only use with RVG 5200 and RVG 6200 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 17: Rvg Connect Technical Specification

    Power Over Ethernet (POE) 802.3af interface Dimension 60 mm (W) x 115 mm (H) x 30 mm (D) 120 g Weight 48 - 56 V DC Input voltage RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 18: Minimum Computer System Requirements

    Backup media Removable/portable, external hard disk drive. Imaging Performance Information Imaging performance of RVG 142, RVG 5200 and RVG 6200 complies with the IEC 61223-3-4: 2000 standard. Controlling the Image Quality For optimum results, perform a control test of the image quality. To do this, see the User &...
  • Page 19: Environmental Requirements

    10 – 90% Atmospheric pressure 700 – 1060 hpa Transport Conditions Temperatures -10 – 60 °C Relative humidity 10 – 90% Atmospheric pressure 700 – 1060 hpa RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 20: Contact Information

    Authorized Representative in Brazil CARESTREAM DENTAL BRASIL EIRELI Rua Romualdo Davoli, 65 1º Andar, Sala 01 - São José dos Campos São Paulo - Brazil Cep (Zip Code): 12238-577 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06...
  • Page 21 For more information, visit: www.carestreamdental.com SM847 Ed06 2020-10...

This manual is also suitable for:

Rvg 5200Rvg 6200

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