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DEXIS IS 3800 User Manual

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Summary of Contents for DEXIS IS 3800

  • Page 2 All trademarks and registered trademarks are the property of their respective holders. The IS 3800W and IS 3800 are intended for professional use only. U.S. Federal law restricts this device to sale by or on the order of a dentist.

  • Page 3: Table Of Contents

    Label Locations ..16 IS 3800W Labels ..16 IS 3800 Labels ..20 Chapter 2 General Regulatory Information . 23 WiFi .
  • Page 4 Specifications..34 IS 3800W ..34 IS 3800 ... 35 Length of Cables Supplied with the Unit .

  • Page 5: Safety Information

    Safety Information Indications for Use The IS 3800 Family system 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.  DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD...
  • Page 8 If the equipment is faulty, turn it OFF, display an “Out of Service”  notice, and contact a qualified DEXIS service technician. Using components, accessories, cables, and spare parts other  than those specified or provided by the manufacturer of this...
  • 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. Keep cells and batteries clean and dry.  DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD...
  • Page 10 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 ...

  • Page 11: Cleaning, Disinfecting, Sterilizing

    3800W handpiece, battery and charging station are dry and clean after cleaning and disinfecting, in order to avoid risk of short circuit. Figure 1 Contact points on IS 3800W handpiece DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD...
  • Page 12 Figure 2 Contact points on battery Figure 3 Contact points on IS 3800W handpiece charging station Figure 4 Contact points on IS 3800W battery charging station Caution: DO NOT allow liquid to enter through the gap, air inlet/outlet, or pin holes when cleaning and disinfecting the scanner.

  • Page 13: Cleaning The Scanner

    To clean the scanner, follow these steps: Dampen (do not soak) a lint-free cloth with lukewarm water. Remove the blood and/or body fluids with the dampened lint-free cloth. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD...

  • Page 14: 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.
  • Page 15 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. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD 11...

  • Page 16: 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 17: Sterilizing The Scanner Tips

    Gravity Autoclave (Class N) Exposure Time at 132°C Exposure Time at Minimum Drying 134°C Time Minimum 15 Minutes Minimum 10 Minutes 15-30 Minutes Important: Do NOT exceed 134°C. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD 13...

  • Page 18: 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. After each patient: Clean and disinfect the scanner.

  • Page 19: Marking And Labeling Symbols

    Contact your local sales representative for additional information on the collection and recovery programs available for this product. Manufacturer’s address Manufactured date CAUTION: Consult accompanying documentation. Refer to instruction manual/booklet. Direct current DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD 15...

  • Page 20: Label Locations

    Medical device Name of the European authorized representative and address of the registered place of business. Name of the Responsible Person in the United Kingdom and address of the registered place of business. Label Locations IS 3800W Labels The following figures illustrate the label locations of the IS 3800W. Figure 9 IS 3800W Box Label 16 Chapter 1 Safety Information...
  • Page 21 Figure 10 IS 3800W Scanner Label Figure 11 IS 3800W Charge Station Labels DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD 17...
  • Page 22 Figure 12 IS 3800W Battery Charge Station Label 18 Chapter 1 Safety Information...
  • Page 23 Figure 13 IS 3800W Battery Label DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD 19...

  • Page 24: Is 3800 Labels

    IS 3800 Labels The following figures illustrate the label locations of the IS 3800. Figure 14 IS 3800 Box Label Figure 15 IS 3800 Scanner Label 20 Chapter 1 Safety Information...
  • Page 25 Figure 16 IS 3800 Detachable Cable Label DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD 21...
  • Page 26 22 Chapter 1 Safety Information...

  • Page 27: 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 IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD...
  • Page 28 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:...
  • Page 29 Mode of operation Continuous operation Flammable Not suitable for use in the presence of anesthetics flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD...

  • Page 30: Wifi

    Conformity with EN/IEC 60601-1-2 IEC 60601-1-2: 2014 EMC requirements and t ests, Medical Electrical Equipment including CISPR 11:2009+A1:2010 Group 1, Class B. Electromagnetic Compatibility Precautions Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Medical equipment must be installed and put into service according to the EMC information provided in this documentation.

  • Page 31: Guidance And Manufacturer's Declarations

    Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) The IS 3800 Family is intended for use in the electromagnetic environment specified below. The customer or user of the IS 3800 Family should assure that it is used in such an environment. Emissions...
  • Page 32 Fully Compliant with IEC 60601-1-2: 2014 The IS 3800 Family is intended for use in the electromagnetic environment specified below. The customer or the user of the IS 3800 Family should assure that it is used in such an environment.
  • Page 33 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) The IS 3800 Family is intended for use in the electromagnetic environment specified below. The customer or the user of the IS 3800 Family should assure that it is used in such an environment. Immunity...
  • Page 34 For the immunity to proximity fields from RF wireless communications equipment, the IS 3800 Family is compliant with the test levels specified below, according to IEC60601-1-2 standard. The customer or user of the IS 3800 Family should assure that it is used in such an environment. Test...

  • Page 35: Compliance With International Regulations

    Radio Equipment Directive 2014/53/EU (IS 3800W only)  Medical Devices Regulations 2002 (SI618) as subsequently  amended by the EU Exit Regulations of 2019 (SI 791) and 2020 (SI 1478). DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD...
  • Page 36 32 Chapter 2 Regulatory Information...

  • Page 37: Technical Specifications

    China (Shanghai) Pilot Free Trade Zone 201206 Shanghai PEOPLE'S REPUBLIC OF CHINA Manufacturer Dental Imaging Technologies Corporation 450 Commerce Drive Quakertown, PA USA 18951 Model IS 3800W IS 3800 DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD 33...

  • Page 38: Is 3800 Family Technical Specifications

    IS 3800 Family Technical Specifications IS 3800W Components Technical Specifications Sensor CMOS technology 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 Anti-fogging By airflow...
  • Page 39 Handpiece 229 x 38 x 50 mm dimensions (with normal/side tip) without cable Components Technical Specifications Weight 190g (with normal/side tip, no cable) Handpiece Input: 5 V DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD...

  • Page 40: Length Of Cables Supplied With The Unit

    Illustration of Part Length of Part Name —IS 3800W Cable (m) Backup Power 2.0 m Cable AC Adapter 1.8 m Illustration of Part Length of Part Name —IS 3800 Cable (m) Detachable Cable 2.0 m 36 Chapter 3 Technical Specifications...

  • Page 41: Is 3800 Family Environmental Requirements

    Video card NVIDIA GeForce RTX 2060, 6 NVIDIA GeForce GTX 1050 Ti or GB memory Quadro P3000 or similar Video card Support OpenGL 4.3 and Support OpenGL 4.3 and driver OpenCL 1.1 OpenCL 1.1 DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD...
  • Page 42 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 IS 3800 Family. Important: It is MANDATORY to check that your...

  • Page 43: Contact Information

    4 Longwalk Road Stockley Park Uxbridge UB11 1FE United Kingdom List of Importers for European Union According to the MDR 2017/745 PaloDEx Group Oy Nahkelantie 160 04300 Tuusula, FINLAND DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977)_RevisionD 39...
  • Page 44 40 Chapter 4 Contact Information...
  • Page 45 RevisionD 2023-05 © 2023 Dental Imaging Technologies Corporation...

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