Acteon Newtron Slim B. LED User Manual
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Acteon Newtron Slim B. LED User Manual

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SLIM & Slim B.LED handpiece

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Summary of Contents for Acteon Newtron Slim B. LED

  • Page 1 User Manual SLIM & Slim B.LED handpiece...
  • Page 2 This document is an English translation of the original French version. Reference J12920 version V6 and drawing number NBAFFR030F...

  • 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 sterilisation 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

    1 Documentation This document contains the following information: Indications for use Medical device description Installation of the medical device Medical device use Preparation for cleaning and disinfection of the medical device Monitoring and general maintenance of the medical device Maintenance to be performed by the user 1.1 Associated documentation This document must be used in association with the following documents: Document title...
  • Page 8 Page 6/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 9: Required Information

    2.3 Using accessories not supplied by the manufacturer The handpiece is designed to operate with SATELEC, a company of Acteon group dental tips and files. The use of tips or files made by other manufacturers will damage the handpiece, break tips and files and void the warranty. ...

  • Page 10: Latest Document Update

    2.7 Latest document update 09/2017 2.8 Date of first CE marking 2013 2.9 Accessory usage conditions The accessories and the handpiece must be cleaned, disinfected and sterilised prior to each use. Page 8/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 11: Unpacking The Medical Device

    3 Unpacking the medical device When you receive your medical device, check for any damage that may have occurred during transportation. If you have received this medical device by mistake, please contact the supplier to arrange for it to be collected. If you have any questions or requirements, contact your supplier.
  • Page 12 Page 10/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 13: Installing The Medical Device

    There is a handpiece with SLIM B.LED to white LED connector and a handpiece with SLIM B.LED to blue LED connector. 4.2 Handpiece cord The SLIM cord is only compatible with Acteon handpieces with SLIM connector. The cord ensures irrigation circulation and electrical connection between the medical device and the handpiece.
  • Page 14 The torque wrenches must be replaced every year. Page 12/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 15: Dispensing A Treatment

    5 Dispensing a treatment 5.1 Accessory usage conditions The accessories and the handpiece must be cleaned, disinfected and sterilised prior to each use. Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Associated documentation page 5. 5.2 Preparation for use To prepare your medical device, follow the steps below: 1.
  • Page 16 Page 14/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 17: Disinfection And Sterilising

    The instructions relating to cleaning, disinfection and sterilisation protocols for accessories provided by SATELEC, a company of Acteon group have been approved for each medical device and accessory. The applicable guides are listed in the chapter Associated documentation page 5.
  • Page 18 Page 16/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 19: Monitoring And Routine Maintenance

    7 Monitoring and routine maintenance Check the cleanliness of the handpiece nosepiece. It must be clean, smooth and corrosion-free. The handpiece must screw easily and firmly inside it. Check the condition of the handpiece rear seals, which must not be distended, torn or broken. Before and after use, check the medical device and its accessories entirely for any problems.
  • Page 20 Page 18/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 21: Identifying Incorrect Operation

    Tip loose Replace your torque wrench (once a year) Faulty connector contact Clean the cord contacts Return to the Acteon Customer Service team to replace Handpiece cord wire(s) cut the cord 8.3 Water leakage Symptoms: water is leaking between the base of the handpiece and its cord.
  • Page 22 Page 20/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 23: Technical Specifications Of The Medical Device

    9 Technical specifications of the medical device 9.1 Identification Manufacturer SATELEC, a company of Acteon group Name of the medical device Newtron SLIM and Newtron SLIM B.LED handpiece 9.2 Handpiece Length 110 mm Diameter maximum 18 mm Weight 44 g for SLIM handpiece and 48 g for SLIM B. LED handpiece 9.3 Light...
  • Page 24 Vibration frequency ≥ 28 kHz. Tip amplitude ≤ 200 µm. Page 22/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 25: Regulations And Standards

    10 Regulations and standards 10.1 Applicable standards and regulations This medical device complies with the essential requirements of European Directive 93/42/EEC. It was designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system. This equipment is designed and developed in compliance with the Electrical Safety standard IEC60601-1 in force. 10.2 Medical class of the device Class of medical device: IIa according to 93/42/EEC directive 10.3 Symbols...
  • Page 26 Symbol Meaning Fragile, handle with care Store in a dry place Sterilise prior to each use Biohazard Sterilisation at 134°C in an autoclave Sterilisation at 132°C in an autoclave Washer-disinfector for thermal disinfection CE marking CE marking Year of manufacture YYYY Manufacturer Do not dispose of as household waste...
  • Page 27 Use a dipping tank for cleaning Use a soft brush for cleaning Use a lint-free cloth for cleaning Use an ultrasonic tank for cleaning. Use a swab for cleaning Use deionised or osmosis-purified water for cleaning Use an alcohol disinfectant wipe for pre-disinfection and cleaning. Do not use the ultrasonic tank for cleaning.

  • Page 28: Manufacturer Identification

    10.4 Manufacturer identification SATELEC 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 Page 26/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 29: Branch Addresses

    PITAMPURA, DELHI - 110034 - INDIA SPAIN Tel. +91 11 47 018 291 / 47 058 291 / 45 618 291 ACTEON MEDICO-DENTAL IBERICA, S.A.U. Fax. +91 79 2328 7480 Avda Principal n°11 H info.in@acteongroup.com Poligono Industrial Can Clapers...

  • Page 30: 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 27.
  • Page 31 Page 29/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...

  • Page 32: Index

    Index: – After installation 11 Index handpiece 5 humidity 11 After installation 17 altitude 21 incorrect operation 19 Amplitude 22 approved dealers 7 Manufacturer 21 medical class 23 B.LED 11 non-use 17 cleaned 8, 13 cleaning the irrigation system 17 piezoelectric ultrasonic generator 7 pressure 21 damage 17...
  • Page 33 Index: – ultrasonic vibrations wrenches ultrasonic vibrations 7 update 8 User Manual 3, 5 Vibration frequency 22 wrench 5 wrenches 5 Page 31/32 - User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F...
  • Page 34 User Manual | SLIM handpiece | J12921 | V6 | (13) | 09/2017 | NBAFEN030F 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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