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Precautions
Physician training
Please see the appropriate indication-specific IFP addendum for more information on
indication-specific physician training.
Implanting physicians - Implanting physicians should be experienced in DBS
procedures and should review the procedures described in the implant manuals before
surgery.
Prescribing physicians - Prescribing physicians should be experienced in the diagnosis
and treatment of DBS-indicated diseases and should be familiar with the use of the
neurostimulation system.
Medical procedure coordination
Turning the neurostimulator off - The decision to turn off a patient's implanted
neurostimulator in order to perform medical diagnostic or therapeutic procedures may
result in unforeseen consequences and should therefore be carefully considered based
on the patient's underlying medical condition. Consultation with the appropriate medical
professionals (prescribing or implanting clinicians) is recommended.
Storage and sterilization
Component packaging - Do not implant a component if the following circumstances
have occurred:
▪
The storage package has been pierced or altered because component sterility cannot
be guaranteed and infection may occur.
▪
The component shows signs of damage because the component may not function
properly.
▪
The use-by date has expired because component sterility cannot be guaranteed and
infection may occur; also, neurostimulator battery longevity may be reduced and may
require early replacement.
Sterilization - Medtronic has sterilized the package contents according to the process
indicated on the package label before shipment. This device is for single use only and is
not intended to be resterilized.
Storage temperature: leads and extensions - Do not store or transport the lead or
extension above 57 °C (135 °F) or below –34 °C (–30 °F). Temperatures outside this
range can damage components.
Storage temperature: neurostimulators - Do not store or transport the neurostimulator
above 52 °C (125 °F) or below –18 °C (0 °F). Temperatures outside this range can
damage components.
8 English Information for prescribers 2017-05-01
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