Intended Use; Intended Purpose - Kls Martin Group Sonicweld Rx Gebrauchsanweisung

Ultrasonic Unit SonicWeld Rx®
Instructions for Use

3 Intended Use

3.1

Intended Purpose

The SonicWeld Rx® system is used for fixing resorbable SonicPins in the bone and for smoothing resorbable
Resorb x® or Resorb xG foils and membranes.
For additional information on SonicPins as well as Resorb x® and Resorb xG implants, please refer to the
"Osteosynthesis Implants Resorb x® and SonicPin Rx" Instructions for Use.
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 77 and section 7 "Safety Checks (SC)", page 82.
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withdrawn from service.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.
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.
Revision 04 57