Storage, Handling and Transport. Store implanted components like Stimulators, 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.
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.
Store external components like the Remote Control, External Trial Stimulator, ETS Adapter, OR
Cable and Extension between -20 ° to 60 °C (-4 ° to 140 °F). 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.
Handle the system components and accessories with care. Do not drop them or submerge them
in water. Accessories, including the Remote Control, must be kept dry and 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 away from pets, pests, and
children to avoid damage to the device.
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. Do not clean any of the
accessories while they are directly or indirectly connected to a power outlet.
Safety Information
Vercise™ PC Information for Prescribers
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