Carestream DENTAL CS 3800 Safety, Regulatory & Technical Specification User Manual
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Carestream DENTAL CS 3800 Safety, Regulatory & Technical Specification User Manual

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CS 3800
Safety, Regulatory, and Technical
Specifications User Guide

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Summary of Contents for Carestream DENTAL CS 3800

  • Page 1 CS 3800 Safety, Regulatory, and Technical Specifications User Guide...
  • Page 2 © Carestream Dental LLC, 2021. The information in this document is subject to change. Neither Carestream Dental LLC nor any of its subsidiaries shall be liable for errors contained herein or for incidental damages in conjunction with the furnishing, performance, or use of this material.

  • Page 3: Table Of Contents

    Scanner Tips ..12 Marking and Labeling Symbols . .13 Label Locations ..14 CS 3800 Labels ..14 Chapter 2 General Regulatory Information . .17 WiFi .
  • Page 4 Technical Model ....25 Specifications CS 3800 Technical Specifications ...25 Length of Cables Supplied with the Unit ... .27 CS 3800 Environmental Requirements .

  • Page 5: Indications For Use

    Safety Information Indications for Use The CS 3800 is a digital optical scanning device used to record the topographic characteristics of teeth or dental impressions in three dimensions. The resulting topographic impressions are intended for use in the computer-aided design and manufacturing of dental restorative prosthetic devices, dental implant prosthetic devices, and orthodontic models.

  • Page 6: Conventions In This Guide

    Conventions in This Guide The following special messages emphasize information or indicate potential risks to personnel or equipment. WARNING: Warns you to avoid injury to yourself or others by following the safety instructions precisely. Caution: Alerts you to a condition that might cause serious damage.

  • Page 7: Warnings And Safety Instructions

    This unit is not intended for use with flammable anesthetics or flammable agents.  DO NOT pull or twist the cable.  DO NOT drop the scanner or the accessories. CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01...
  • Page 8 1.83 meters away from the patient.  If the equipment is faulty, turn it OFF, display an “Out of Service” notice, and contact a qualified Carestream Dental service technician.  Using components, accessories, cables, and spare parts other than...
  • Page 9  Do not use any cell or battery which is not designed for use with the equipment.  Always purchase the battery recommended by the device manufacturer for the equipment. CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01...
  • Page 10  Keep cells and batteries clean and dry.  Wipe the cell or battery terminals with a clean, dry cloth if they become dirty.  Do not leave a battery on prolonged charge when not in use.  After extended periods of storage, it may be necessary to charge and discharge the cells or batteries several times to obtain maximum performance.

  • Page 11: Cleaning, Disinfecting, Sterilizing

    Remove the blood and/or body fluids with the dampened lint-free cloth. Caution: DO NOT touch the contact points on the battery or the scanner. Do not allow liquid to infiltrate the cover. CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01...

  • Page 12: Disinfecting The Scanner

    Disinfecting the Scanner After each patient, the scanner must be thoroughly disinfected. To adequately disinfect the scanner, follow the disinfectant manufacturer’s instructions for the appropriate contact time. Important: If the scanner is visibly soiled, it must be thoroughly cleaned prior to disinfecting. “Cleaning the Scanner.”...

  • Page 13: Cleaning And Sterilizing The Scanner Tips

    Do not soak the scanner tips in disinfectant overnight.  Dry the scanner tips thoroughly before mounting onto the scanner.  Do not use an ultrasonic cleaning machine to clean the scanner tips. CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01...

  • Page 14: Manually Cleaning The Scanner Tips

    Manually Cleaning the Scanner Tips To manually clean the scanner tips, follow these steps: Rinse excess soil from the tip. Using a soft brush, apply an enzymatic detergent solution (e.g., Metrex EmPower) to all surfaces. Rinse under clean, running water. Inspect the tip.

  • Page 15: Sterilizing The Scanner Tips

    Minimum 3 Minutes 20-30 Minutes Gravity Autoclave Exposure Time at 132°C Exposure Time at 134°C Minimum Drying Time Minimum 15 Minutes Minimum 10 Minutes 15-30 Minutes Important: Do NOT exceed 134°C. CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01 11...

  • Page 16: Precautions Before Use

    Precautions Before Use Perform the following activities on your product and accessories before use. Cleaning, Disinfecting, and Sterilizing 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 17: Marking And Labeling Symbols

    Manufacturer’s address Manufactured date CAUTION: Consult accompanying documentation. Refer to instruction manual/booklet. Direct current Medical device Name of the European authorized representative and address of the registered place of business. CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01 13...

  • Page 18: Label Locations

    Label Locations CS 3800 Labels The following figures illustrate the label locations of the CS 3800. Figure 1 CS 3800 Box Label Figure 2 CS 3800 Scanner Label 14 Chapter 1 Safety Information...
  • Page 19 Figure 3 CS 3800 Charge Station Labels Figure 4 CS 3800 Battery Charge Station Label CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01 15...
  • Page 20 Figure 5 CS 3800 Battery Label 16 Chapter 1 Safety Information...

  • Page 21: General Regulatory Information

    Standard: Usability EN/IEC 62366-1 Medical Devices – Part 1: Application of usability engineering to medical devices EN 62304 / IEC 62304 Medical device software - Software life cycle Processes CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01 17...
  • Page 22 Compliance with European and International Standards EN ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process EN 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...
  • Page 23 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. CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01...

  • Page 24: Wifi

    WiFi The wireless version of the CS 3800 intraoral scanner operates with the 802.11ac protocol. Only channel 42 is used for the handpiece. The central frequency is 5210MHz. The channel bandwidth is 80MHz. The radio output power is 18.5 dBm (nominal).

  • Page 25: Guidance And Manufacturer's Declarations

    Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) The CS 3800 is intended for use in the electromagnetic environment specified below. The customer or user of the CS 3800 should assure that it is used in such an environment. Emissions...
  • Page 26 Fully Compliant with IEC 60601-1-2: 2014 The CS 3800 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 3800 should assure that it is used in such an environment. Immunity Test IEC 60601 Test...
  • Page 27 Electromagnetic Immunity (IEC 60601-1-2) The CS 3800 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 3800 should assure that it is used in such an environment. Immunity IEC 60601 Test Level...

  • Page 28: Compliance With International Regulations

    For the immunity to proximity fields from RF wireless communications equipment, the CS 3800 is compliant with the test levels specified below, according to IEC60601-1-2 standard. The customer or user of the CS 3800 should assure that it is used in such an environment. Test Frequency...

  • Page 29: Factory

    Sensor technology 1/2.9 inch CMOS Illumination LED: Red, Blue, Green Field of view 16 x 14 mm 13 x 7 mm (posterior tip) Depth of field -2 to +16 mm CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01 25...
  • Page 30 Anti-fogging By airflow technology Digital connection WiFi 5GHz, 802.11ac Handpiece 226 x 38 x 60 mm dimensions with normal tip or side tip Components Technical Specifications Weight 240 g (with battery) Handpiece Input: 5 V 5A (with backup power cable) 4.2 V 3A (with battery) Handpiece...

  • Page 31: Length Of Cables Supplied With The Unit

    10 – 85% RH Humidity Transportation and 10 – 95% RH Storage Relative Humidity Operating Atmospheric 700 – 1060 hPa Pressure Transportation and 600 – 1060 hPa Storage Atmospheric Pressure CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01...

  • Page 32: Computer System Requirements

    The All-In-One computer system requirement is an exception. The computer and its screen should be situated in or close to the operating area, in the visual field of the practitioner when using the CS 3800. Important: It is MANDATORY to check that your system configuration is compatible with the computer system requirements for the CS 3800 software.

  • Page 33: Manufacturer's Address

    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 CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01 29...
  • Page 34 30 Chapter 4 Contact Information...

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