Intended Use - Kls Martin Group Sonicweld Rx Gebrauchsanweisung/Technische Beschreibung

Instructions for Use / Technical Description
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SonicWeld Rx Ultrasonic Unit
1.3

Intended Use

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The SonicWeld Rx
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on SonicPins Rx is available in the manual for the osteosynthesis material Resorb x
Possible areas of application include:
Non-load bearing parts of the cranium, including bone augmentation.
A load bearing part of the cranium is, for example, the mandible.
The ultrasonic unit is a medical device class IIa in compliance with EC Directive 93/42/EEC and
the applicable, national legal requirements.
• According to these requirements the device may only be used for the described application
and only by qualified operators. Furthermore, the following must be observed:
— The applicable industrial safety regulations
— The applicable accident prevention measures
— These instructions for use
According to these requirements operators of the device must
•
— only use materials and equipment free of defects
— observe the intended use
— protect themselves, the patient and others from any dangers
Sonotrodes
• The standard sonotrodes are used to apply the SonicPins Rx
straight and angled versions (item 19 and 20, foldout of the front page). Angled
sonotrodes facilitate work in areas that are difficult to access, for example in the posterior
molar regions.
The smoothing sonotrodes are used for smoothing Resorb x
•
in straight and angled versions (item 21 and 22, foldout of the front page).
V. 2.2
is a system to fix resorbable SonicPins Rx
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in bones. Further information
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. They are available in
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implants. They are available
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.
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