Boston Scientific Vercise DB-1110-C Manual página 12

Vercise™ DBS Physician Manual
If any of the above is required by medical necessity, the procedure(s) should be
performed as far from the implanted components as possible. Ultimately, however, the
Stimulator may require explantation as a result of damage to the device or patient harm.
Operating Temperature. The operating temperature of the External Trial Stimulator
and Remote Control is 5 °C to 40 °C (41 °F to 104 °F). For proper operation, do not use
the Charger if the ambient temperature is above 35 °C (95 °F).
Other Models of External Devices. Only the Remote Control, Clinician
Programmer, and Charger that were provided with the Boston Scientific Vercise™ DBS
System should be used with the Vercise DBS System. Other models of these devices will
not function with the Vercise DBS System.
Patient Activities Requiring Coordination. Loss of coordination is a potential side
effect of DBS therapy. Patients should exercise reasonable caution when participating in
activities requiring coordination, including those that they were able to perform prior to
receiving DBS therapy (e.g., swimming).
Patient Activity Following Surgery. During the two weeks following surgery, it is
important for the patient to exercise extreme care so that appropriate healing will secure
the implanted components. During this period, the patient should not attempt to move
heavy objects. Instruct the patient to restrict head movements, including extension or
flexion of the neck and rotation of the head, until healing is complete.
Resterilization. For single patient use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the structural integrity of the
device and/or lead to device failure which, in turn, may result in patient injury, illness or
death. Reuse, reprocessing or resterilization may also create a risk of contamination of
the device and/or cause patient infection or cross‑infection, including, but not limited to,
the transmission of infectious disease(s) from one patient to another. Contamination of
the device may lead to injury, illness or death of the patient. If resterilization is desired,
obtain a new sterile device for implantation.
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.
Vercise™ DBS Physician Manual
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