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Table of Contents
Related Manuals for Acteon Newtron P5
Summary of Contents for Acteon Newtron P5
- Page 1 User Manual Newtron P5 & Newtron P5 B.LED...
- Page 2 This document is an English translation of the original French version. Reference J61100 version V6 and drawing number NBACFR030F...
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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 4 10.3 The power is not as expected 10.4 Ultrasounds not working 10.5 Water leakage 11 Technical specifications of the medical device 11.1 Identification 11.2 Generator 11.3 Length of cords 11.4 Irrigation 11.5 Footswitch 11.6 Environmental characteristics 11.7 Environmental restrictions 11.8 Main performance characteristics 12 Regulations and standards 12.1 Applicable standards and regulations 12.2 Medical class of the device...
- 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...
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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 Keep the original documentation for your medical device and its accessories for future reference. When loaning out or selling the medical device, the documentation must be provided with it. ® Page 6/38 - User Manual | Newtron P5 | J61101 | V6 | (13) | 09/2017 | NBACEN030F...
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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: Warranty
2.6 Warranty The screws marked A, B, C, D and E must not be unscrewed by the user under any circumstances as this may void the warranty for the medical device. 2.7 Latest document update 09/2017 2.8 Date of first CE marking 2013 ®... -
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 10/38 - User Manual | Newtron P5 | J61101 | V6 | (13) | 09/2017 | NBACEN030F...
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Page 13: Connect The Medical Device
Procure the relevant kit and the installation and maintenance instructions for water and air filters and cartridges [J11330]. SATELEC, a company of Acteon group accepts no responsibility for damage caused by an installation provided by a service provider that has not been approved by us. ... -
Page 14: Connecting The Medical Device To The Electrical Network
4.5 Connecting the medical device to the electrical network 1. Set the medical device's mains switch to "O" OFF position. 2. Connect the mains cord to the control unit's mains connector. 3. Connect the power lead to the mains socket. ®... -
Page 15: Installing The Medical Device
5 Installing the medical device Place the medical device in the position that is suitable for your activity. The medical device must be placed on a secure and flat surface or a surface with a maximum slope of five degrees. Check that the cords do not hinder the movement or free circulation of anyone. - Page 16 The torque wrenches must be replaced every year. ® Page 14/38 - User Manual | Newtron P5 | J61101 | V6 | (13) | 09/2017 | NBACEN030F...
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Page 17: Dispensing A Treatment
6 Dispensing a treatment 6.1 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. 6.2 Preparation for use To prepare your medical device, follow the steps below: 1. - Page 18 ® Page 16/38 - User Manual | Newtron P5 | J61101 | V6 | (13) | 09/2017 | NBACEN030F...
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Page 19: Medical Device Description
The ultrasound power must be adjusted in accordance with the tip used and the required treatment. The operating power of the tips must be selected in compliance with the Acteon tips color coding system (CCS tips). Each tip must be used in accordance with the settings defined in the ultrasonic generator irrigation and power settings table [J58000]. -
Page 20: Air Inlets
To avoid losing any device components, do not loosen the configuration button fully so that it comes off. Each tip must be used in accordance with the settings defined in the ultrasonic generator irrigation and power settings table [J58000]. 7.6 Air inlets Air inlets ensure correct ventilation of the control unit. -
Page 21: 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 22: Cleaning, Disinfecting And Sterilising Accessories
® To prepare for cleaning, remove the various parts of the Newtron P5 B.LED as shown here. 8.2 Cleaning, disinfecting and sterilising accessories Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Associated documentation page 5. ®... -
Page 23: Monitoring And Routine Maintenance
[J12911]. 2. Clean and disinfect the medical device as indicated in the chapter Clean and disinfect the medical device page 19. 3. Follow the instructions for cleaning, disinfecting and sterilising SATELEC, a company of Acteon group accessories [J81001] and [J02001]. -
Page 24: Corrective Maintenance
6. Check that there is no leakage and that the spray works correctly. A damaged or blocked cartridge must be replaced. 9.3 Corrective Maintenance In the event of faulty operation, the following corrective maintenance actions may be performed by the user. 9.3.1 Replacing the fuses The medical device is protected by two fuses in the mains connector. - Page 25 3. Disconnect the mains cord from the mains connector. 4. Insert the tip of a flathead screwdriver into the notch on top of the fuse holder to release it. 5. Remove the used fuses. 6. Replace the used fuses with fuses of the same type and same rating. 7.
- Page 26 ® Page 24/38 - User Manual | Newtron P5 | J61101 | V6 | (13) | 09/2017 | NBACEN030F...
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Page 27: Identifying Incorrect Operation
If the incorrect operation is not described in the tables below, please contact your supplier or the customer service team at SATELEC, a company of Acteon group. Do not use the medical device if it appears to be damaged or faulty. Isolate the medical device and make sure that it cannot be used. -
Page 28: Ultrasounds Not Working
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 10.5 Water leakage Symptoms: water is leaking between the base of the handpiece and its cord. -
Page 29: Technical Specifications Of The Medical Device
11 Technical specifications of the medical device 11.1 Identification Manufacturer SATELEC, a company of Acteon group ® Name of the medical device Newtron P5 B.LED 11.2 Generator Supply voltage 100 - 240 VAC Power supply frequency 50 - 60 Hz Power consumption 60 - 60 VA... -
Page 30: Environmental Restrictions
Atmospheric operating pressure Between 800 hPa and 1060 hPa Maximum operating altitude Equal to or less than 2000 metres Storage temperature 0 to +50°C Storage RH 10% to 100 %, including condensation Atmospheric storage pressure Between 500 hPa and 1060 hPa Transportation temperature 0 to +50°C Transportation RH... -
Page 31: Regulations And Standards
12 Regulations and standards 12.1 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. 12.2 Medical class of the device Class of medical device: IIa according to 93/42/EEC directive 12.3 Symbols... - Page 32 Symbol Meaning Packaging unit Fragile, handle with care Store in a dry place Biohazard Sterilisation at 134°C in an autoclave Sterilisation at 132°C in an autoclave Washer-disinfector for thermal disinfection Type B part in contact Alternating current Water connection Intensity Irrigation CE marking CE marking...
- Page 33 Symbol Meaning Do not dispose of as household waste Recycle your lamps and professional electrical equipment with Récylum Under the United States Federal Law, this medical device must only be Rx Only sold by or under the orders of a qualified doctor. Serial Number Packaging Number Use a dipping tank for cleaning...
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Page 34: Manufacturer Identification
Use a syringe for cleaning Use a washer-disinfector for cleaning and disinfection Use a pre-vacuum air autoclave for sterilisation 12.4 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. -
Page 35: Branch Addresses
PITAMPURA, DELHI - 110034 - INDIA Tel. +91 11 47 018 291 / 47 058 291 / 45 618 291 SPAIN Fax. +91 79 2328 7480 ACTEON MEDICO-DENTAL IBERICA, S.A.U. info.in@acteongroup.com Avda Principal n°11 H Poligono Industrial Can Clapers LATIN AMERICA... -
Page 36: 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 33. - Page 37 ® Page 35/38 - User Manual | Newtron P5 | J61101 | V6 | (13) | 09/2017 | NBACEN030F...
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Page 38: Index
Index: – altitude Récylum 13 Index gas-filled atmosphere 28 general instructions relating to the complete range of ultrasonic dental generators 3 altitude 28 Amplitude 28 approved dealers 7 handpiece 5 Handpiece support 17 humidity 13 B.LED 17 incorrect operation 25 cartridge 21 indexing points 13 cleaned 15... - Page 39 Index: – repair wrenches repair 7 repairer 7 seal 26 silicone supports 17 slope of five degrees 13 spray 17, 25 sterilised 15 supply pipe 11 switch 18, 25 temperature 27 tip 5, 7, 25-26 ultrasonic vibrations 7 update 8 User Manual 3, 5 Vibration frequency 28 water filter 21...
- Page 40 ® User Manual | Newtron P5 | J61101 | V6 | (13) | 09/2017 | NBACEN030F 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...