Boston Scientific Vercise Mode D'emploi page 15

Stimulator Orientation: Orient the Stimulator parallel to the skin surface. Suboptimal
placement of the Stimulator may result in a revision surgery. Patients should avoid touching
the Stimulator site or incisions. If patients notice a change in the appearance of the skin at the
Stimulator location, such as the skin becoming thin over time, they should contact their healthcare
provider.
In order to ensure effective device communications, including device programming, and proper
charging, perform the following:
• For rechargeable IPGs, orient the Stimulator parallel to the skin surface and at a depth
less than 2 cm and greater than 0.5 cm below the skin.
• For non-rechargeable Vercise Genus IPGs, orient the Stimulator parallel to the skin
surface and at a depth less than 2.5 cm below the skin to ensure effective device
communication.
• For the non‑rechargeable Vercise PC IPG (DB‑1140), orient the Stimulator parallel to the
skin surface. There is no depth restriction for the Vercise PC IPG.
• The etched writing "This Side Up" must be facing out of the pocket toward the patient's
skin.
Suboptimal placement of the Stimulator may result in the inability to communicate with the device
or inability to recharge and may require a revision surgery.
Patients should be instructed not to change the orientation of or turn over the Stimulator. If the
Stimulator flips over in the body, then it cannot communicate or be charged. If stimulation cannot
be turned on after charging, the Stimulator may have changed orientation or rotated; patients
should contact their healthcare provider to arrange an evaluation of the system.
Storage, Handling and Transport. Store implanted components, such as the Stimulator,
Leads, and Lead 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 5 °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 (DB‑4100‑A and SC‑4100‑A), and Charging System between
‑20 °C to 60 °C (‑4 °F to 140 °F). Store the Push‑Button OR 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.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Safety Information
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