Infection.
Follow proper infection control procedures and inform patients to avoid showering and touching
the bandages.
Theft detectors and metal screening devices.
Certain types of antitheft devices, such as those used at
entrances or exits of department stores, libraries, and other public establishments, and airport security
screening devices may affect stimulation. Patients who are implanted with nonadjacent multiple leads and
patients who are sensitive to low stimulation thresholds may experience a momentary increase in their
perceived stimulation, which has been described by some patients as uncomfortable or jolting. Patients
should use caution when approaching such a device and should request assistance to bypass the device. If
they must proceed through the device, patients should turn off the EPG and proceed with caution, being
sure to move through the detector quickly.
Implantation of multiple leads.
If multiple leads are implanted, leads and extensions should be routed in
close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could
cause the patient unwanted stimulation.
Handling and Implementation
Single use only.
The EPG header is intended for single use only.
Exposure to liquids.
Device components should be stored where they will not be exposed to liquids or
excessive moisture, which can damage the package materials and components.
Care and handling of components.
Use extreme care when handling system components prior to use.
Excessive heat, traction, bending, and twisting, or the use of sharp instruments may damage components
and cause them to fail.
Package or component damage.
Do not use the device if the package or components show signs of
damage. Return any suspect components to Abbott Medical for evaluation.
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