Boston Scientific Vercise PC Instrucciones De Uso página 10

Vercise™ PC Information for Prescribers
• 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 PC 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 the 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 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.
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™ PC Information for Prescribers
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