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Acteon Newtron P5 - Required Information and Safety; Intended Use; Operating Principle; Repair and Modification Policy

Acteon Newtron P5
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2 Required information
2.1 Indication for use
This medical device is used with a dental ultrasonic handpiece to which an ultrasonic instrument is attached. It is
designed for the treatment of prophylaxis,periodontics, endodontics and preservation and restoration dentistry.
2.2 Operating principle
An electrical signal emitted by the medical device is supplied to the ultrasonic handpiece. This is connected to the
medical device via a cord. The handpiece comprises a piezoelectric ceramic transducer, which transforms the
electrical signal into ultrasonic vibrations.
Mechanical vibrations are transmitted to a tip or a dental file attached to the end of the ultrasonic handpiece.
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.
2.4 Connecting and disconnecting accessories during use
Do not tighten or loosen the tips when the handpiece is activated.
2.5 Repairing or modifying the medical device
Contact the supplier of your device. Using the services of an unapproved repairer could render your device dangerous
for you and your patients.
Do not repair or modify the device without seeking the prior permission of SATELEC, a company of Acteon group.
If the device is modified or repaired, specific checks and tests must be carried out to ensure that the medical device is
still safe to use.
In the event of doubt, contact an approved dealer or the SATELEC, a company of Acteon group Customer Service team:
www.acteongroup.com
satelec@acteongroup.com
SATELEC, a company of Acteon group, at the request of technical personnel working for the network of
approved dealers, will provide any information required to repair defective parts on which they may perform
repairs.
User Manual | Newtron
®
P5 | J61101 | V6 | (13)|09/2017 | NBACEN030F - Page 7/38

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