3
Users
•
The distraction 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.
It is the user's responsibility to avoid or minimize the general risks posed by surgical
•
interventions.
The user
•
— bears the responsibility for the proper performance of the surgical procedure;
— must be thoroughly familiar with the surgical technique as well as with the set of
implants and the instruments and accessories used;
— is responsible for selecting the right implant components and implanting them
properly.
4
Implant Materials
For implant material details, please refer to our website: www.klsmartin.com
5
Indications
The two distractors Rotterdam Midline and Bologna Midline are to be used for distraction
osteogenesis of the mandibular symphysis in cases of severe crowding of the mandibular
region and transversal mandibular deficits.
The Rotterdam Midline Distractor is supported only by the bone.
The Bologna Midline Distractor is supported by both bone and teeth.
Fig. 5-1:
Rotterdam Midline Distractor
For details on the selection of the distractor and the combination of the individual components,
see section 10 "Selecting the Distraction System", page 33.
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Rotterdam-Midline Distractor / Bologna-Midline Distractor
Fig. 5-2:
Instructions for Use
Bologna Midline Distractor
V. 3.0