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Vercise™ Deep Brain Stimulation Systems
Storage, Handling, and Transport. Implanted components, such as the Stimulator, Leads,
Lead Extensions, and Adapters, have no special storage or handling requirements.
The non‑rechargeable Stimulator will enter storage mode if its temperature falls below 5 °C (41 °F).
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 (46 °F).
Store external components like the Remote Control, External Trial Stimulator, ETS Adapter,
O.R. Cable and Extension (DB‑4100A), Programming Wand, and Charging System between
‑20 °C to 60 °C (‑4 °F to 140 °F). Store the Push‑Button O.R. Cable (DB‑4120‑08) between
0 °C to 45 °C (32 °F to 113 °F). Do not expose the external 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.
Handle the system components and accessories with care. Do not drop them or submerge
them in water. Avoid all sources of water that could 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. 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 Lead Extension.
•
Do not tie Suture(s) directly to the DBS Lead or Lead 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.
Surgical Tape: If tape is used to temporarily secure the DBS Lead during surgery, caution
should be used to ensure the Lead is not cut or damaged when removing the tape.
Sutures: Do not apply Sutures tightly around the DBS Leads, as this may damage the insulation
of the DBS Lead and may result in DBS Lead failure.
Tissue Reaction: Temporarily, there may be some pain in the area of the Stimulator as the
incisions heal. If there is excessive redness around the wound area, it should be checked for
infection. In rare cases, adverse tissue reaction to implanted materials can occur.
Information for Prescribers
92691903-02
12 of 755
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