Boston Scientific Vercise DB-1110-C Manual página 13

• 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.
Setscrews. Before tightening Setscrews, always test impedance to confirm electrical
connectivity. Tightening a Setscrew onto a contact may damage the contact and may
result in the need to replace the DBS Lead or DBS Extension.
Sterilization. Contents of the surgical kits are supplied sterile using an ethylene oxide
process. Do not use if sterile barrier is damaged. If damage is found, call your Boston
Scientific representative and return the damaged part to Boston Scientific.
Stimulator Orientation. To ensure proper charging, orient the Stimulator parallel
to the skin surface and at a depth less than 2 cm below the skin. The etched writing
"This Side Up" must be facing out of the pocket towards the patients skin. Suboptimal
placement of the Stimulator may result in the inability to recharge and/or a revision
surgery.
Never attempt to change the orientation of or turn over the Stimulator. Patients should
avoid touching the Stimulator site or incisions. If the Stimulator flips over in the
body, then it cannot be charged. If stimulation cannot be turned on after charging,
the Stimulator may have changed orientation or rotated; patients should contact their
physician to arrange an evaluation of the system.
If a patient notices a change in appearance of the skin at the Stimulator location, such as
the skin becoming thin over time, they should contact their physician.
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.
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. 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 °C to 60 °C (‑4 °F to 140 °F).
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 and not 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.
Safety Information
Vercise™ DBS Physician Manual
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