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

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Intended Use

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The SonicWeld Rx
smoothing resorbable Resorb x
For additional information on SonicPins as well as Resorb x
refer to the "Osteosynthesis Implants Resorb x
According to the EC Directive 93/42/EEC and applicable national legal provisions, the following
applies:
The system may only be used by competent medical staff for the application described,
•
paying due regard to
— current safety-at-work regulations
— current accident prevention regulations
— these Instructions for Use
• According to the above provisions, it is the user's responsibility to
— ensure that all working equipment used is in perfect condition
— protect himself/herself, patients and third-parties from hazards
Gebrüder Martin shall not be responsible for complications caused by wrong indications,
•
wrong implant selection, incorrect combination of system components and surgical
technique, limitations of the treatment used, or lack of hygiene.
The product must be used according to indication.
•
The operational safety of the device must be verified at regular intervals, see section 6
•
"Maintenance", page 64 and section 11 "Safety Checks (SC)", page 75.
If the device is not functionally reliable and/or safe to operate, it must be marked as such
and withdrawn from service. A technical check is mandatory in any such case.
In order to avoid damage due to improper installation or use and not to compromise the
•
warranty or guarantee, this Gebrüder Martin system must not be used in conjunction with
third-party systems.
WARNING
Risk of injury due to unauthorized modification of the product!
Altering the product in any way can pose a life hazard due to electric shock! Therefore,
unauthorized modifications are strictly forbidden under any circumstances.
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system is used for fixing resorbable SonicPins in the bone and for
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or Resorb xG foils and membranes.
Instructions for Use / Technical Description
Ultrasonic Unit SonicWeld Rx
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and Resorb xG implants, please
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and SonicPin Rx" Instructions for Use.
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