Prior To Implantation - KLS Martin group Rotterdam Instrucciones De Uso

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Prior to Implantation

• Prior to use, distraction systems must be sent through the entire processing cycle of
suitable cleaning, disinfecting and sterilization procedures.
Prior to implantation, the distraction system must be visually inspected and an activation
•
test must be carried out, verifying that the activator of the distraction system can be
rotated and that the distractor moves correctly as a result.
We also recommend you to perform a 3-D CT scan and / or have a stereo lithographic
•
model created prior to implantation to determine the optimal position for the distraction
system or make adjustments in advance. Patient-specific anatomical models are available
from KLS Martin on request (www.klsmartin.com).
NOTICE
Potential misinterpretation of examination results!
Distraction systems can cause irritating artifacts in CT scans and MRIs.
WARNING
Danger of burns or accidental implant movement when using magnetic resonance
imaging (MRIs)!
Due to the further development and increasingly higher energy density of MRI systems, an
adverse effect on implants cannot be ruled out in the future. Therefore, MRIs are not
permitted unless potential patient injury can definitely be ruled out.
Due to the magnetic field, MRIs pose a danger of heating up or dislocating potentially
•
susceptible implants.
• For external fixators made of steel, MRI compatibility must be checked in each individual
case.
Steel implants acc. to ISO 5832-1 are classified as paramagnetic or non-magnetic.
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Titanium is completely non-magnetic.
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Rotterdam-Midline Distractor / Bologna-Midline Distractor
Instructions for Use
V. 3.0