Stimwave LLC LBRD2R4 Manuale Utente

English

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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.

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.