Boston Scientific Vercise PC Instrucciones De Uso página 11

• 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.
Storage, Handling and Transport. Store components between 0 °C to 45 °C (32 °F to
113 °F) in an area where they are not exposed to liquids or excessive moisture. Temperatures
outside of the stated range can cause damage. If stored in conditions beyond the required storage
temperature, do not use the components and return to Boston Scientific.
The non-rechargeable Stimulator will enter storage mode if its temperature falls below 8 °C. When
the Stimulator is in storage mode, it will not connect to a Remote Control or Clinician Programmer.
To exit storage mode, increase the Stimulator temperature above 8 °C.
Do not expose the Remote Control or External Trial Stimulator 2 (ETS 2) to excessively hot or
cold conditions. Do not leave the devices in your car or outdoors for extended periods of time.
The sensitive electronics can be damaged by temperature extremes, particularly high heat. If
the Remote Control or ETS 2 is to be stored for a period of time, be careful that the storage
temperature does not exceed -20–60° C (-4–140° F).
Handle the system components and accessories with care. Do not drop them or submerge
them in water. Avoid all sources of water that can come into contact with the devices. Although
reliability testing has been performed to ensure quality manufacturing and performance, dropping
the devices on hard surfaces or in water, or other rough handling, can permanently damage the
components.
Care must be taken to avoid damaging the DBS Lead with sharp instruments or excessive force
during surgery. The following guidelines will help to ensure the longevity of components:
• Do not sharply bend or kink the DBS Lead or Extension.
• Do not tie suture(s) directly to the DBS Lead or Extension body.
• Avoid pulling an implanted DBS Lead taut; stress relief loops may help to minimize
tension on the DBS Lead.
• Avoid handling the DBS Lead with sharp instruments; use only rubber-tipped forceps.
• Take care when using sharp instruments, such as hemostats or scalpels, to prevent
damaging the DBS Lead.
Component Removal & Disposal. Any explanted components should be returned to
Boston Scientific. The Stimulator should be explanted in the case of cremation and returned to
Boston Scientific. Cremation may cause the Stimulator battery to explode.
The Remote Control should not be disposed of in fire, as this device contains batteries which may
explode causing injury when exposed to fire. Used batteries should be disposed of in accordance
with local laws and regulations.
Cleaning the Remote Control and ETS 2. The components can be cleaned using
alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy detergents should be
removed with a damp cloth. Do not use abrasive cleansers for cleaning.
Safety Information
Vercise™ PC Information for Prescribers
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