Boston Scientific Vercise Gevia 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.
Operating Temperature. The operating temperature of the ETS, Remote Control, and
Programming Wand is 10–40 °C (50–104 °F). For proper operation, do not use the Charging
System if the ambient temperature is above 35 °C (95 °F).
Storage, Handling and Transport. Store implanted components like the Stimulator, leads, and
extensions, 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.
Store external components like the Remote Control, External Trial Stimulator, ETS Adapter, OR
Cable and Extension, and Charging System between -20 to 60 °C (-4 to 140 °F). Do not expose
them 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.
Handle the system components and accessories with care. Do not drop them or submerge them
in water. Accessories, including the Remote Control and Charger, must be kept dry. They should
not be exposed to moisture. 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. Keep the Remote Control and Charger away
from pets, pests and children to avoid damage to the devices.
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 or Charger 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.
Safety Information
Vercise Gevia™ Information for Prescribers
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