Users - Kls Martin Group Sonicweld Rx Gebrauchsanweisung

Sonotrodes
• The standard sonotrodes are used for the application of SonicPins. They are available in 2 different
designs, straight and angled (11, 13, front fold-out page). The angled sonotrodes facilitate working in
regions that are hard to access, e.g. the posterior teeth region.
• The smoothing sonotrodes are used for smoothing out Resorb x® and Resorb xG implants. They too are
available in a straight version and an angled one (14, 15, front fold-out page).
• The angled standard sonotrode (13, front fold-out page) has an axial working end for inserting the
SonicPins, and an angled working end for smoothing out Resorb x® and Resorb xG implants.
Sonotrode materials coming into body contact with the patient or user during application all have good
biological compatibility in accordance with ISO 10993-1.
3.1.1

Users

The SonicWeld Rx® system may only be used by competent medical staff who, due to their specialized
training, experience and knowledge of the relevant regulations, have the necessary qualification for using
the system correctly.
Users must have adequate knowledge of the rules of medical practice, as well as the state of the art and
the contents of pertinent scientific articles published by medical authors.
The user must be thoroughly familiar with the surgical technique as well as with the set of implants and the
instruments and accessories used.
The user bears the responsibility for
• the proper performance of the surgical procedure
• selecting the right implant components and implanting them properly
• avoiding or minimizing the general risks posed by surgical interventions
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Ultrasonic Unit SonicWeld Rx®
Instructions for Use
Revision 04