Acteon Cube LED User Manual
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Acteon Cube LED User Manual

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Summary of Contents for Acteon Cube LED

  • Page 1 User Manual Handpiece...
  • Page 2 This document is an English translation of the original French version. Reference J28820 version V1 and drawing number NO40FR030A...

  • Page 3: Table Of Contents

    Contents 1 Documentation 1.1 Associated documentation 1.2 Electronic documentation 2 Required information 2.1 Indication for use 2.2 Operating principle 2.3 Using accessories not supplied by the manufacturer 2.4 Connecting and disconnecting accessories during use 2.5 Repairing or modifying the medical device 2.6 Warranty 2.7 Latest document update 2.8 Date of first CE marking...
  • Page 5 Detailed manual and automated instructions Information concerning conditioning for sterilization Recommendations for the inspection of parts Please refer to the instructions for the entire range of SATELEC, a company of Acteon group dental ultrasonic generators for information about the following: Documentation format...

  • Page 7: Documentation

    Users are asked to keep documentation close at hand for reference when necessary. User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A - Page 5/30...
  • Page 8 Page 6/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 9: Required Information

    If the device is modified or repaired, specific checks and tests must be carried out to ensure that the medical device is still safe to use. In the event of doubt, contact an approved dealer or the SATELEC, a company of Acteon group Customer Service team: www.acteongroup.com satelec@acteongroup.com...
  • Page 10 Page 8/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 11: Unpacking The Medical Device

    If you have any questions or requirements, contact your supplier. The handpiece includes the following components: a handpiece and its cord; a Quick Start-Clean for the handpiece and cord set [J87580]. User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A - Page 9/30...
  • Page 12 Page 10/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 13: Installing The Medical Device

    4 Installing the medical device 4.1 Handpiece The Cube LED handpiece must be used in combination with an ultrasound dental generator and tips for intra-oral surgical procedures. 4.2 Connecting the handpiece Connect the cord and handpiece assembly to the connector on the front of the control unit. ...
  • Page 14 Page 12/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 15: Dispensing A Treatment

    12. Switch on the medical device. 13. After water drainage, check that the spray works correctly. Your medical device is now ready to use. User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A - Page 13/30...
  • Page 16 Page 14/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 17: Disinfection And Sterilizing

    6.2 Cleaning, disinfecting and sterilizing accessories Refer to the cleaning, disinfection and sterilization instructions for accessories listed in the chapter Associated documentation page 5. User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A - Page 15/30...
  • Page 18 Page 16/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 19: Monitoring And Routine Maintenance

    Operate the device at minimum power, at maximum irrigation flow rate for 2 minutes.  User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A - Page 17/30...
  • Page 20 Page 18/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 21: Identifying Incorrect Operation

    Faulty cord contact handpiece and its cord Contacts for the front panel connector are faulty Return to Acteon Customer Service to change the box User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A - Page 19/30...
  • Page 22 Page 20/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 23: Technical Specifications Of The Medical Device

    Immersion The medical device must not be immersed. 9.7 Main performance characteristics Vibration frequency ≥ 28 kHz. Tip amplitude ≤ 200 µm. User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A - Page 21/30...
  • Page 24 Page 22/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 25: Regulations And Standards

    Do not use the medical device if the patient is wearing a medical device for vagus nerve stimulation Biohazard Sterilization at 132°C in an autoclave User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A - Page 23/30...
  • Page 26 Clean in a dipping tank Clean with a soft brush Clean with a lint-free cloth Clean in an ultrasonic tank Clean with a swab Page 24/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 27: Manufacturer Identification

    A Company of ACTEON Group 17, avenue Gustave Eiffel BP 30216 33708 MERIGNAC cedex France Tel. +33 (0) 556.34.06.07 Fax. +33 (0) 556.34.92.92 E.mail: satelec@acteongroup.com. www.acteongroup.com User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A- Page 25/30...

  • Page 28: Branch Addresses

    Tel. +86 10 646 570 11/2/3 Fax. +86 10 646 580 15 info.cn@acteongroup.com THAILAND ACTEON (THAILAND) LTD 23/45 Sorachai Building 16th floor - Sukumvit 63 Page 26/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 29: Disposal And Recycling

    When your medical device has reached the end of its service life, contact your nearest dental equipment dealer, or the Acteon head office or one of the company branches to find out how to proceed. The relevant contact details are given in the chapter Branch addresses page 26.
  • Page 30 Page 28/30 - User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A...

  • Page 31: Index

    5 ultrasonic dental generators 3 wrenches 5 incorrect operation 19 Manufacturer 21 medical class 23 User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A- Page 29/30...
  • Page 32 User Manual | Cube LED | J12829 | V1 | (17) | 07/2017 | NO40US030A SATELEC S.A.S. A Company of ACTEON Group 17 av. Gustave Eiffel BP 30216 33708 MERIGNAC cedex FRANCE Tel. +33 (0) 556 34 06 07 Fax. +33 (0) 556 34 92 92 E-mail: satelec@acteongroup.com...

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