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H
OW TO USE THIS MANUAL
This manual will help you understand how to use and care for your
neurostimulator system. It also provides you with warnings and precautions
you should know about. You should discuss with your clinician any questions or
concerns you have after reading this manual. Please refer to the Freedom
Spinal Cord Stimulator (SCS) System Product Safety Guide for EMC related
safety information.
This device complies with Part 18 of the FCC Rules. Per FCC 18.213, See
Warnings section in this document for the interference potential of the device
and methods for correcting interference. See Maintenance section in this
document for the instructions on system maintenance.
Per FCC 15.21, changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate the
equipment.
Per FCC 15.19(a)(3) and (a)(4) This device complies with part 15 of the FCC
Rules. Operation is subject to the following two conditions: (1) This device may
not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired
operation. FCC ID 2AHXALBRD2R4.
I
NDICATIONS FOR
U
SE
The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole
mitigating agent, or as an adjunct to other modes of therapy used in a
multidisciplinary approach for chronic, intractable pain of the trunk and/or
lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit
is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and
the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A
Stimulator or the Receiver Kit Freedom-8A Stimulator. The trial devices are
solely used for trial stimulation (no longer than 30 days) to determine efficacy
before recommendation for a permanent (long term) device.
