Boston Scientific Vercise DBS Mode D'emploi page 13

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.
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.
Do not expose the Remote Control or Charging System components 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. For proper operation, do not use the Charger if the ambient
temperature is above 35° C (95° F). If the Remote Control or the Charging System
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.
Safety Information
Physician Manual
91098825-07 Rev A 9 of 333