Medtronic DBS 3387 Gebrauchsanweisung Seite 17

Implant Considerations – Do not implant a component of the system
when:
The storage package has been pierced or altered; or if the
■
component shows signs of damage; or
The "Use By" date has expired, because this can adversely affect
■
storage package sterility.
Medical Environment
Most routine diagnostic procedures, such as fluoroscopy and x-rays, are
not expected to affect system operation. However, the following
precautions should be noted.
Effects on Other Medical Devices – The neurostimulation system may
affect the operation of other implanted devices, such as cardiac
pacemakers and implantable defibrillators. Possible effects include sensing
problems and inappropriate device responses. If the patient requires
concurrent implantable pacemaker and/or defibrillator therapy, careful
programming of each system may be necessary to optimize the patient's
benefit from each device.
Electrocautery – Electrocautery can cause temporary suppression of
neurostimulator output and/or reprogramming of the neurostimulator. If use
of electrocautery is necessary, the current path (ground plate) should be
kept as far away from the neurostimulator and lead as possible. The use of
bipolar cautery is recommended.
External Defibrillators – Safety for use of external defibrillatory
discharges on patients with neurostimulation systems has not been
established. External defibrillation may damage a neurostimulator.
If external defibrillation is necessary and the situation permits, follow these
precautions to minimize current flowing through the neurostimulator and
lead-extension system:
Position defibrillation paddles as far from the neurostimulator as
■
possible.
Position defibrillation paddles perpendicular to the implanted
■
neurostimulator-lead system.
■ Use the lowest clinically appropriate energy output (watt seconds).
■ Confirm neurostimulation system function following any external
defibrillation.
High Radiation Sources – High radiation sources, such as cobalt 60 or
gamma radiation, should not be directed at the neurostimulator. If a patient
requires radiation therapy in the vicinity of the neurostimulator, place lead
shielding over the device to prevent radiation damage.
Lithotripsy – Use of high output ultrasonic devices, such as an
electrohydraulic lithotriptor, is not recommended for patients with an
implanted neurostimulation system. While there is no danger to the patient,
exposure to high output ultrasonic frequencies may result in damage to the
neurostimulator circuitry. If lithotripsy must be used, do not focus the beam
near the neurostimulator.
Technical Manual English 15