Boston Scientific Vercise Gevia Instrucciones De Uso página 10

Vercise Gevia™ Information for Prescribers
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.
• Diathermy – The energy generated by diathermy can be transferred to the Vercise Gevia
DBS System and may result of damage to the device or patient harm.
• X-ray and CT scans may damage the Stimulator if stimulation is on. X-Ray and CT
Scans are unlikely to damage the Stimulator if stimulation is turned off.
• Diagnostic ultrasonic scanning is unlikely to damage the Stimulator if stimulation is
turned off.
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 System may require
explantation as a result of damage to the System 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.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse,
Resterilization.
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.
After use, return the Stimulator, DBS Leads, and DBS Extensions to Boston Scientific and dispose
of other components and packaging in accordance with hospital, administrative and/or local
government policy.
Check the expiration date on the package before opening the sterile package and using the
contents. Do not use the contents if the current date is past the expiration date, if the package is
opened or damaged, or if contamination is suspected because of a defective sterile package seal.
• Inspect the seal integrity of the outer tray before use.
• Inspect the seal integrity and sterile indicator on the inner tray. The sterile indicator will
be green with red stripes if sterile. Yellow stripes indicate the tray is not sterile. If the tray
is not sterile, do not use the components and return to Boston Scientific.
• Open the inner tray in the sterile field.
Vercise Gevia™ Information for Prescribers
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