Table of Contents
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Table of Contents
Related Manuals for Acteon SATELEC
Summary of Contents for Acteon SATELEC
- Page 1 User Manual Newtron LED handpiece...
- Page 2 This document is an English translation of the original French version. Reference J12610 version V4 and drawing number NB62FR020D...
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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 10.7 Disposal and recycling 11 Index...
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Page 5: Documentation
This document must be used in association with the following documents: Document title References Consulting electronic user instructions J00007 General instructions relating to all ultrasonic SATELEC handpieces J12861 Cleaning, disinfection and sterilisation protocols for handpieces J12911 Cleaning, disinfection and sterilisation instructions for keys... - Page 6 Page 4/28 - User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D...
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Page 7: 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 8: Accessory Usage Conditions
2.9 Accessory usage conditions The accessories and the handpiece must be cleaned, disinfected and sterilised before use. Page 6/28 - User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D... -
Page 9: 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 10 Page 8/28 - User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D...
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Page 11: Installing The Medical Device
4 Installing the medical device 4.1 Handpiece The handpieces are designed to operate exclusively with SATELEC dental ultrasonic generators. 4.2 Handpiece cord The cord enables irrigation flow and provides an electrical connection between the medical device and the handpiece. Never rotate the handpiece connector on its cord as this can damage your medical device. -
Page 12: Install An Led Ring
The torque wrenches must be replaced every year. 4.5 Install an LED ring Connect the light ring to the Newtron LED handpiece, making sure that the polarity of the light ring is correct: 1. Align the "+" marks on the light ring and on the body of the handpiece close to the electrical contacts of the light ring 2. -
Page 13: Dispensing A Treatment
5 Dispensing a treatment 5.1 Accessory usage conditions The accessories and the handpiece must be cleaned, disinfected and sterilised before use. Refer to the cleaning, disinfection and sterilisation protocols for accessories listed in the chapter Associated documentation page 3. 5.2 Preparation for use To prepare your medical device, follow the steps below: 1. - Page 14 Page 12/28 - User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D...
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Page 15: Disinfection And Sterilising
The instructions relating to cleaning, disinfection and sterilisation protocols for accessories supplied 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 3. - Page 16 Page 14/28 - User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D...
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Page 17: 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 18 Page 16/28 - User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D...
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Page 19: Identifying Incorrect Operation
The tip is incorrectly tightened Replace your torque wrench once a year Faulty connector contact Clean the cord contacts Return to the Acteon Customer Service team to replace the Handpiece cord wire(s) cut cord 8.3 Water leakage Symptoms: water is leaking between the base of the handpiece and its cord. - Page 20 Page 18/28 - User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D...
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Page 21: 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 LED handpiece 9.2 Handpiece Length 112 mm Diameter maximum 21 mm Weight 73 g 9.3 Light Light source... - Page 22 Page 20/28 - User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D...
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Page 23: 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 24 Symbol Meaning 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 Ultrasonic bath CE marking CE marking Year of manufacture YYYY Manufacturer 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 sold Rx Only...
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Page 25: Quick Start And Quick Clean Symbols
Symbol Meaning Serial Number Packaging Number 10.4 Quick Start and Quick Clean symbols 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 an alcohol disinfectant wipe for pre-disinfection and cleaning. Clean under running water Use a washer-disinfector for cleaning and disinfection Use a pre-vacuum air autoclave for sterilisation... -
Page 26: Manufacturer Identification
10.5 Manufacturer identification SATELEC A Company of the ACTEON Group 17, avenue Gustave Eiffel ZI du Phare 33700 MERIGNAC France Tel. +33 (0) 556.34.06.07 Fax. +33 (0) 556.34.92.92 E-mail: satelec@acteongroup.com www.acteongroup.com 10.6 Branch addresses AUSTRALIA/NEW ZEALAND RUSSIA ACTEON AUSTRALIA/NEW ZEALAND ACTEON RUSSIA... - Page 27 Tel. +39 0331 376 760 Fax. +44 1480 477 381 Fax. +39 0331 376 763 info.uk@acteongroup.com info.it@acteongroup.com U.S.A. & Canada ACTEON North America LATIN AMERICA ACTEON LATINA AMERICA 124 Gaither Drive, Suite 140 Bogotà - COLOMBIA Mount Laurel, NJ 08054 - USA Mobile: +57 312 377 8209 Tel.
- Page 28 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 24.
- Page 29 Index: – After installation Vibration frequency medical class 21 11 Index non-use 15 After installation 15 altitude 19 Amplitude 19 piezoelectric ultrasonic generator 5 approved dealers 5 pressure 19 cleaned 6, 11 recycling 26 cleaning the irrigation system 15 Récylum 26 repair 5 repairer 5 damage 15...
- Page 30 User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D SATELEC A Company of the ACTEON Group 17 av. Gustave Eiffel ZI du Phare 33700 MERIGNAC FRANCE Tel. +33 (0) 556 34 06 07 Fax. +33 (0) 556 34 92 92 satelec@acteongroup.com...
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Questions and answers
Can the LED Motor cord be placed in a Sterilizer or does it need to be at a low temp -VPRO.
hello, we are currently processing the newtron handpiece in a washer disinfector but want to verify if the dry time must be 40 minutes or can we lower the Dry time to 10-15 minutes?