Acteon SATELEC Newtron SLIM User Manual
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Acteon SATELEC Newtron SLIM User Manual

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Summary of Contents for Acteon SATELEC Newtron SLIM

  • Page 1 User Manual Handpiece...

  • 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 Date of inclusion of EC marking 2.4 Latest document update 2.5 Repairing or modifying the device 2.6 Accessory usage conditions 3 Removal from packaging, installation, connections 3.1 Unpacking the device 4 Description of the medical device...
  • Page 4 9.6 Disposal and recycling 9.7 Disposing of accessories 10 Index...
  • Page 5 Foreword The medical device SATELEC ® that you are about to install and use in your practice is a medi- cal device designed for professional use. It comprises the chosen tool with which you will pro- vide treatment within the context of your work. To ensure optimum safety for yourself and your patients, comfort in your daily practice and to benefit fully from the technology of your medical device, please read the documentation provided carefully.

  • Page 7: Documentation

    1 Documentation This document contains the following information: indications for use; description of the medical device; installation of the medical device; 1.1 Associated documentation This document must be used in association with the following documents: Document title References ® Cleaning, disinfection and sterilization protocols for Wrenches SATELEC J81001 ®...
  • Page 8 Page - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...

  • Page 9: Required Information

    2 Required information 2.1 Indication for use The dental ultrasound handpiece is used in association with a conventional dental piezoelectric ultrasonic gene- rator and a tip or a dental file. The treatments performed with this medical device are those described in the User Manual for your ultrasonic generator, in the chapitre Associated documentation page 5.
  • Page 10 Page - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...

  • Page 11: Removal From Packaging, Installation, Connections

    3 Removal from packaging, ins- tallation, connections 3.1 Unpacking the device When you receive your device, check for any damage that may have occurred during transportation. If you have received this 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 - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...

  • Page 13: Description Of The Medical Device

    4 Description of the medical device 4.1 SLIM handpiece Only handpieces with SLIM connector SATELEC ® can be connected to the medical device. There is a handpiece with SLIM connector without LED, and a handpiece with SLIM connector B.LED with white or blue LED. 4.2 Attach a tip or a file A tip or a file vibrates correctly when it is perfectly tightened without being forced beyond its stop point.
  • Page 14 Page - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...

  • Page 15: Cleaning, Disinfecting And Sterilizing

    5 Cleaning, disinfecting and ste- rilizing The instructions relating to accessory cleaning, disinfection and sterilization protocols provided by SATELEC ® have been approved for each medical device and accessory. The applicable guides are listed in chapitre Asso- ciated documentation page 5 They can be downloaded at the following address: www.satelec.com/documents In all cases, the local regulations in force relating to the accessory cleaning, disinfection and sterilization pro-...
  • Page 16 Page - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...

  • Page 17: Monitoring And Maintenance Of The Medical Device

    6 Monitoring and maintenance of the medical device Before and after each use, check that the device and its accessories are not faulty in any way. This is neces- sary to detect any isolation fault or damage. If necessary, replace damaged parts. User Manual •...
  • Page 18 Page - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...

  • Page 19: Maintenance

    7 Maintenance 7.1 Identifying incorrect operation In the event of incorrect operation, refer to the tables below to quickly identify and repair the non-complex parts of the medical device. If the incorrect operation is not described in the tables below, please contact your supplier or the After-Sales team at SATELEC ®...
  • Page 20 Page - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...

  • Page 21: Technical Specifications For The Medical Device

    8 Technical specifications for the medical device 8.1 Identification SATELEC ® Manufacturer Newtron ® SLIM et Newtron ® SLIM B.LED Nom du medical device 8.2 SLIM handpiece Length (in mm) Maximum diameter (in mm) 18 Weight (in g) 44 for SLIM handpiece and 48 for SLIM handpiece B. LED 8.3 Irrigation Water pressure at inlet 1 to 5 bars...
  • Page 22 Page - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...

  • Page 23: Regulations And Standards

    9 Regulations and standards 9.1 Official Texts This medical device complies with the essential requirements of European Directive 93/42/EEC. This equip- ment is designed and developed in compliance with Electrical Safety standard IEC60601-1 in force. It was desi- gned and manufactured in accordance with an EN ISO 13485-certified quality assurance system. 9.2 Medical class of the device This medical device is a class IIa device according to European Directive 93/42/EEC.
  • Page 24 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 - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...

  • Page 25: Branch Addresses

    Tel. +49 21 04 95 65 10 Fax. +49 21 04 95 65 11 e-mail: info@de.acteongroup.com SPAIN ACTEON MEDICO-DENTAL IBERICA, S.A.U. Avda Principal n°11 H Poligono Industrial Can Clapers 08181 SENTMENAT (BARCELONA) - SPAIN Tel. +34 93 715 45 20 Fax.
  • Page 26 Tel. +86 10 646 570 11/2/3 Fax. +86 10 646 580 15 e-mail: beijing@cn.acteongroup.com THAILAND ACTEON (THAILAND) LTD 23/45 Sorachai Building 16th floor - Sukumvit 63 Road, Klongton Nua - Wattana, BANGKOK 10110 - THAILAND Tel. +66 2 714 3295 Fax.
  • Page 27 When your medical device has reached the end of its service life, contact your nearest dental equipment dea- ler, or ACTEON GROUP head office or one of the company branches to find out how to proceed. The relevant contact details are given in the chapitre Branch addresses page 23.
  • Page 28 Page - User Manual • SLIM handpiece • J12921 • V1 • (13) • 04/2013 • NBAFEN030B...
  • Page 29 Index: – Altitude Pressure 10 Index fault 15 first inclusion of EC marking 7 Altitude 19 gas-filled atmosphere 19 Amplitude 19 approved dealers 7 Handpieces 5 Hextril® Hexedrin 11 B.LED 11 humidity 11 Bleach 11 Hydrogen peroxide 11 Chlorexidine 11 incorrect operation 17 cleaned 7 indexing points 11...
  • Page 30 Index: – printed copy Wrenches printed copy 5 Quick Clean 5 Quick Start 5 recycling 25 repair 7 repairer 7 Saline solution 11 seal 17 SLIM cord 11, 17 Sodium Hypochlorite 11 spray 17 Sterile water 11 sterilized 7 Temperature 19 tip 7, 17 Tip 17 Tips 5...
  • Page 31 Ref: J12921 • V1 • (13) • 04/2013 • NBAFEN030B A Company ofACTEON Group• 17 av.GustaveEiffel • BP30216 • 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...

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