Acteon Satelec Newtron P5XS B.LED User Manual
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Acteon Satelec Newtron P5XS B.LED User Manual

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Newtron P5XS B.LED

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Summary of Contents for Acteon Satelec Newtron P5XS B.LED

  • Page 1 User Manual Newtron P5XS B.LED...

  • 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 Warranty 2.7 Accessory usage conditions 3 Removal from packaging, installation, connections 3.1 Unpacking your medical device 3.2 Positioning the medical device...
  • Page 4 4.21 Filling the tank 4.22 Pump 4.23 Cleaning the irrigation system 5 Cleaning, disinfecting and sterilizing 5.1 Cleaning and disinfection of the medical device 5.2 Cleaning and disinfecting accessories 5.3 Diamond coated tips 6 Monitoring and maintenance of the medical device 7 Maintenance 7.1 Identifying incorrect operation 7.1.1 No operation...
  • Page 5 Foreword The medical device SATELEC ® that you are about to install and use in your practice is a medical device designed for professional use. It comprises the chosen tool with which you will provide 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; use of the medical device; preparation for cleaning and disinfection of the medical device; monitoring and general maintenance of the medical device; maintenance to be performed by the user.
  • Page 8 - User Manual • Newtron ® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C Page...

  • Page 9: Required Information

    2 Required information 2.1 Indication for use This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis. 2.2 Operating principle An electrical signal emitted by the medical device is supplied to the dental ultrasonic handpiece. This is connected to the medical device via a cord.

  • Page 10: Warranty

    2.6 Warranty The screws marked A, B and C must not under any circumstances be unscrewed by the user as this may void the warranty for the medical device. 2.7 Accessory usage conditions Accessories and must be cleaned, disinfected and sterilized prior to use. - User Manual •...

  • Page 11: Removal From Packaging, Installation, Connections

    3 Removal from packaging, installation, connections 3.1 Unpacking your 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.

  • Page 12: Plugging The Medical Device To The Electrical Network

    Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or cable tray. 3.5 Plugging the medical device to the electrical network 1. Set the medical device's mains switch to stop position O; 2.

  • Page 13: Description Of The Medical Device

    4 Description of the medical device 4.1 Control unit The control unit incorporates technology Newtron ® patented by SATELEC ® . The patented technology Newtron ® controls the tips by Cruise Control ® , an automatic system for setting the frequency and power in real time.

  • Page 14: Connecting And Disconnecting Accessories During Use

    4.6 Connecting and disconnecting accessories during use Do not connect/disconnect the cord(s) or the handpiece when the medical device is switched on and your foot is on the pedal. Do not tighten or loosen the tips when the handpiece is activated. 4.7 Connecting the handpiece Check for the absence of signs of humidity at the connections, and eliminate them if necessary (wipe and blow using a multipurpose syringe).

  • Page 15: Initiating Irrigation

    4.13 Initiating irrigation The medical device must be set to minimum power depending on the required irrigation flow rate. Press the pedal until a spray appears. 4.14 Air inlets Air inlets ensure correct ventilation of the control unit. Leave them uncovered to allow air to circulate. 4.15 Control pedal The ON/OFF type pedal is used by the practitioner to operate the medical device.
  • Page 16 When the irrigation system has been cleaned, perform the following operations: 1. disconnect the handpiece and refer to handpiece predisinfection, cleaning and sterilisation protocols SATELEC ® [J12919]; 2. clean and disinfect the medical device as indicated in the chapter Cleaning and disinfection of the medical device page 15 3.
  • Page 17 5 Cleaning, disinfecting and sterilizing 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 chapter Associated 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 protocols take precedence over the information provided by SATELEC ®...
  • Page 18 To prepare for cleaning, remove the various parts of Newtron ® P5XS B.LED as shown here. 5.2 Cleaning and disinfecting accessories Refer to the accessory cleaning, disinfection and sterilization protocols listed in the chapter Associated documentation page 5. 5.3 Diamond coated tips Diamond coated tips are for single use only.
  • Page 19 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 necessary to detect any isolation fault or damage. If necessary, replace damaged parts. Monitor the cleanliness of the air inlets on the control unit to prevent any heating.
  • Page 20 - User Manual • Newtron ® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C Page...
  • Page 21 7 Maintenance The only preventive maintenance the medical device requires is: checking of accessories; everyday cleaning, disinfection and sterilisation procedures; cleaning. 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.
  • Page 22 7.1.4 Ultrasounds not working Symptoms: the tip does not vibrate, vibration cannot be heard. Possible causes Solutions Tip loose Tighten the tip using the wrench Faulty connector contact Clean the cord contacts ® Handpiece cord wire(s) cut Return to After-Sales Department SATELEC to replace the cord 7.1.5 Water leakage Symptoms: Water is leaking from one of the following places:...
  • Page 23 connect the mains cord to the connector; connect the mains cord to the electrical network; The medical device also has an internal fuse (Ref. FU1 on the printed circuit board) that cannot be accessed by the user. 7.2.2 Replacing the irrigation cassette User Manual •...
  • Page 24 - User Manual • Newtron ® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C Page...
  • Page 25 User Manual • Newtron ® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page...
  • Page 26 - User Manual • Newtron ® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C Page...
  • Page 27 8 Technical specifications for the medical device 8.1 Identification ® Manufacturer SATELEC ® P5XS B.LED Name of the medical device EWTRON 8.2 Control unit Width (in mm) 110, 145 with 300 ml tank, 182 with 500 ml tank Height (in mm) Depth (in mm) Weight (in g) 1 674 with pedal, SLIM cord and 300 ml tank;...
  • Page 28 8.6 Control pedal Width (in mm) Height (in mm) Depth (in mm) Weight (in g) Ingress protection rating: IPX1 8.7 Environmental characteristics Operating temperature +10°C to +30°C Storage temperature -0°C to +60°C Operating humidity 30 % to 75 % Storage humidity 10 % to 70 %, including condensation Atmospheric pressure Between 800 hPa and 1060 hPa Altitude...
  • Page 29 9 Regulations and standards 9.1 Official Texts This medical device complies with the essential requirements of European Directive 93/42/EEC. This equipment is designed and developed in compliance with Electrical Safety standard IEC60601-1 in force. It was designed 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 30 9.3 Standardised Symbols Symbols Meaning Refer to the accompanying documentation Consult the User Manual Accompanying documentation in electronic format BF type Class 1 Alternating voltage Sterilisation at 132°C in an autoclave Washer disinfector for thermal disinfection EC marking Do not dispose of as household waste Year of manufacture YYYY Control pedal...
  • Page 31 9.4 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 User Manual • Newtron ® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page...
  • Page 32 INDIA e-mail: info@de.acteongroup.com ACTEON INDIA SPAIN B-94, GIDC Electronic Estate - Sector 25 – ACTEON MEDICO-DENTAL IBERICA, S.A.U. GANDHINAGAR 382028 Gujarat - INDIA Avda Principal n°11 H Tel. +91 79 2328 7473 Poligono Industrial Can Clapers Fax. +91 79 2328 7480 08181 SENTMENAT (BARCELONA) - SPAIN e-mail: info@in.acteongroup.com...
  • Page 33 : sandy.junior@au.acteongroup.com TAIWAN ACTEON TAIWAN 14F-1, N°433, Jinping Rd. Jhonghe Dist., New Taipei City 23563 TAIWAN (R.O.C) Tel. + 886 926 704 505 e-mail : tina.chu@tw.acteongroup.com...
  • Page 34 When your medical device has reached the end of its service life, contact your nearest dental equipment dealer, 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 chapter Branch addresses page 30.
  • Page 35 Index: – 300 ml humidity 10 Index damage 17 demineralised water 13 dental file 7 dental ultrasonic generators 5 disinfected 8 disposal 32 300 ml 13 drinking water 13 500 ml 13 earthing pin 13 Electrical Safety 27 electronic user instructions 5 end of the day 13 endodontics 7 After installation 13...
  • Page 36 Index: – incorrect operation Vibration frequency incorrect operation 19 Quick Clean 5 indicator light 19 Quick Start 5 irrigation flow 11-12 Regulatory 5, 32 kit F12304 20 removal of the button 11 kit F62202 13, 20 repair 7 LED 11 scaling 7 light function 13 seal 20...
  • Page 37 Index: – water leak Wrenches water leak 20 wipes 15 Wrenches 5 User Manual • Newtron ® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page...
  • Page 38 - User Manual • Newtron ® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C Page...
  • Page 39 Ref : J62159 • V3 • (13) • 11/2013 • NBADUS030C 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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