Safety Information
Storage, Handling, and Transport. Do not expose the Remote Control 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.
The Precision Novi IPG will enter storage mode if its temperature falls below 8 °C. When the
IPG is in storage mode, it will not connect to a Remote Control or Clinician Programmer. To exit
storage mode, increase the IPG temperature above 8 °C.
If the Remote Control 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".)
Component Disposal. Do not dispose of the Remote Control in a fire. The batteries in this
device can explode in a 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.
Remote Control and Wand Cleaning. The Remote Control and Programming Wand can be
cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from
soapy detergents should be removed with a cloth lightly dampened with water. Do not use
abrasive cleansers for cleaning. Do not clean any of the accessories while they are directly or
indirectly connected to a power outlet.
Cell Phones and Other Portable RF Communication Devices. While interference caused by
cell phones is not anticipated, the full effects of interaction with cell phones are unknown at this
time. Patients should be instructed that portable RF communications equipment (for example,
mobile phones) should be kept a minimum distance of 6 inches (15 cm) from the area of the
implanted device. If interference does occur, move the cell phone away from the Stimulator or
turn off the phone. If there is a concern or a problem is encountered, patients should contact
their physician.
Precision Novi™ System Information for Prescribers
90962628-03
5 of 445