Product Info
Safety Information
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
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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 Scientic
DBS System should be used with the Boston Scientic DBS System. Other models of these
devices will not function with the Boston Scientic DBS System.
Patient Activities: 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 exion of the neck and rotation of the head, until healing
is complete.
Setscrews: Before tightening Setscrews, always test impedance to conrm 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 Scientic Technical Support
and return the damaged part to Boston Scientic.