Boston Scientific Vercise Mode D'emploi page 14

Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Operating Temperature: The operating temperature of the External Trial Stimulator, Remote
Control, and Programming Wand is 5 °C to 40 °C (41 °F to 104 °F). For proper operation, do not
use the Charging System if the ambient temperature is above 35 °C (95 °F).
Other Models of External Devices: Only the Remote Control, Charging System
(as applicable), and Clinician Programmer that were provided with the Boston Scientific
DBS System should be used with the Boston Scientific DBS System. Other models of these
devices will not function with the Boston Scientific 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.
Setscrews: Before tightening Setscrews, always test impedance to confirm electrical
connectivity. Tightening a Setscrew onto a Lead Contact may damage the Contact and may result
in the need to replace the DBS Lead or DBS Lead Extension.
Single Use Only, Do Not Resterilize: 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.
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 Boston Scientific Technical Support
and return the damaged part to Boston Scientific.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
92328649-04 10 of 149