WRIGHT Salvation 153910-1, Manual

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F. MRI SAFETY INFORMATION
The SALVATION
™
Midfoot Reconstruction System implants have not been evaluated
for safety and compatibility in the MR environment. These implants have not been
tested for heating, migration, or image artifact in the MR environment. The safety of
the SALVATION ™ Midfoot Reconstruction System in the MR environment is unknown.
Scanning a patient who has this device may result in patient injury.
MRI Warnings
There are inherent risks associated with the use of metallic implants in the MR
environment: including component migration, heating, and signal interference or
image distortion near the component(s). Heating of metallic implants is a risk related
to component geometry and material, as well as the MR power, duration, and pulse
sequence. Since MR equipment is not standardized, the severity and likelihood of
occurrence of these adverse effects are unknown for these implants.
Since these devices have not been tested, Wright cannot make a recommendation for the
use of MRIs with these implants, neither for safety considerations nor imaging accuracy.
These components are passive metallic devices. As with all passive devices, there is
potential for interference with certain imaging modalities including image distortion for
MR and X-ray scatter in CT.
G. HANDLING AND STERILIZATION
IMPLANTS
The implants in this system are either provided sterile or non-sterile; the individual
product’s labeling will determine whether or not it is packaged sterile. Implants that are