Boston Scientific Precision Montage MRI Informacion Para Medicos página 9

Safety Information
Stimulator Location. Patients should never attempt to change the orientation or "flip" (rotate
or spin) the Stimulator. Patients should not "finger" or play with the Stimulator. If the Stimulator
flips over in the Patient's body, it cannot be charged. If the Patient knows that the device has
turned, or if stimulation cannot be turned on after charging, the Patient should contact his or her
physician to arrange an evaluation of the system. In some cases, the skin over the Stimulator
may become very thin over time. If this occurs, Patients should contact their physicians.
Lead Location. In some instances a lead can move from its original location, and stimulation
at the intended pain site can be lost. If this occurs, Patients should consult their physician who
may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning
the lead during another operation.
Device Failure. Stimulators can fail at any time due to random component failure, loss of
battery functionality, or lead breakage. If the device stops working even after complete charging
(up to four hours), Patients should turn off the Stimulator and contact their physician so that the
system can be evaluated.
Operating Temperature. The operating temperature of the Trial Stimulator, Remote Control,
and Programming Wand is 5–40 °C (41–104 °F). For proper operation, do not use the Charger
if the ambient temperature is above 35 °C (95 °F).
Storage, Handling and Transport. 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 without
batteries, the storage temperature should not exceed -20 to 60 °C (-4 to 140 °F).
Handle the system external components and accessories with care. Do not drop them or
submerge them in water. 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 these components. (See "Limited Warranty - IPG".)
Upon completion of the Patient Trial, remove the batteries from the Trial Stimulator.
Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery
in these devices can explode in fire. Dispose of used batteries in accordance with local
regulations. The IPG should be explanted in the case of cremation, and returned to Boston
Scientific. External devices to be disposed of per local regulatory requirements. Please contact
your healthcare professional.
Precision Montage™ MRI System Information for Prescribers
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