Boston Scientific Vercise PC Instrucciones De Uso página 10

Vercise™ PC Information for Prescribers
• 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 Vercise PC DBS System should not be subjected to
MRI to avoid damage to the device and patient harm.
• Diathermy – The energy generated by diathermy can be transferred to the Vercise PC
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.
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.
• If the Stimulator was dropped, do not implant it in a patient. The dropped Stimulator
may have lost sterility, experienced a loss of hermeticity, or been otherwise damaged.
Replace the dropped Stimulator with a new, sterile Stimulator prior to implantation.
Return the damaged Stimulator to Boston Scientific.
• Do not use any component that shows signs of damage.
• Do not use if "Use By" date has expired.
Operating Temperature. The operating temperature of the External Trial Stimulator, Remote
Control, and Programing Wand is 5–40 °C (41–104 °F).
Vercise™ PC Information for Prescribers
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For single patient use only. Do not reuse, reprocess or resterilize. Reuse,