Boston Scientific DB-1110-C, Physician'S Manual

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Physician Manual
Physician Manual
92215483-02 8 of 1717
en
Medical Devices/Therapies.
The following medical therapies or procedures may
turn stimulation off, cause permanent damage to the Stimulator, or may cause injury
to the patient:
• Electrocautery – Electrocautery can transfer destructive current into the
DBS Leads and/or Stimulator.
• External Defibrillation – Safe usage of external defibrillation has not been
established and damage should be ascertained following defibrillation.
• Lithotripsy – High frequency signals directed near the Stimulator may damage
circuitry.
• Radiation Therapy – Lead shielding should be used over the Stimulator to
prevent damage from high radiation. Any damage to the device by radiation
may not be immediately detectable.
• Transcranial Stimulation – Safe use of electromagnetic therapies, such as
transcranial magnetic stimulation, have not been established.
• MRI – Patients implanted with the full Vercise DBS System (leads, extensions
and stimulator) should not be subjected to MRI to avoid damage to the device
and patient harm.
Note: Vercise DBS Lead-only system (before Stimulator is implanted) is MR
conditional. An MRI examination can be conducted safely when all
instructions in the supplemental manual MRI Guidelines for Boston Scientific
DBS Systems are followed.
For the latest version of the manual go to www.bostonscientific.com/manuals.
• Diathermy – The energy generated by diathermy can be transferred to the
Vercise™ DBS System and may result of damage to the device or patient
harm.
If any of the above is required by medical necessity, the procedure(s) should be
performed as far from the implanted components as possible. Ultimately, however,
the Stimulator may require explantation as a result of damage to the device or patient
harm.
Sterilization. Contents of the surgical kits are supplied sterile using an ethylene
oxide process. Do not use if sterile barrier is damaged. If damage is found, call your
Boston Scientific representative and return the damaged part to Boston Scientific.
Resterilization. For single patient use only. Do not reuse, reprocess or
resterilize. Reuse, reprocessing or resterilization may compromise the structural
integrity of the device and/or lead to device failure which, in turn, may result in
patient injury, illness or death. Reuse, reprocessing or resterilization may also create
a risk of contamination of the device and/or cause patient infection or cross-infection,
including, but not limited to, the transmission of infectious disease(s) from one
patient to another. Contamination of the device may lead to injury, illness or death of
the patient. If resterilization is desired, obtain a new sterile device for implantation.