Document Reference: ENG-UMAN-000730
Revision: 6.00
Page 10 of 40
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If the packaging appears to be damaged, please return it to Saluda Medical for
replacement.
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Patients should be advised to avoid storing the Evoke™ external accessories outside
the labeled temperature ranges or in steamy environments such as bathrooms and
to keep them dry.
Handling of the eCLS, EPC and Charger
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Patients should be advised to carry and hold their accessories carefully to protect
them from striking hard surfaces or being dropped.
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Patients should be advised to keep their accessories dry and never immerse them in
water.
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Patients should be advised to not plug the Charger into outlets that are in humid
environments – such as a bathroom – or near water.
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If patients need to clean their accessories, refer them to the Evoke™ Instructions for
Use.
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Avoid prolonged skin contact of the external system components (lead adapter, lead
adapter cable, lead adapter extension, eCLS, EPC, Charger and charging coil). Place
clothing or dressings between skin and external system components.
Disposal of the stimulator, EPC and Charger
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The CLS, eCLS, EPC and Charger contain batteries that could explode if they are
thrown into a fire.
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Dispose of your EPC batteries in accordance with your local laws regarding waste
electrical equipment.
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The CLS, eCLS, EPC and Charger should be returned to Saluda Medical.
Disposal of sharps and explanted implants
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Please dispose of any sharps and medical waste according to your usual procedures.
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If you have explanted any component of an Evoke™ System for any reason please
contact Saluda Medical to arrange for its return.
Modifications to components
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The components of the Evoke™ System are not intended to be modified by users or
surgeons in any way.
Potential Risks
Every surgery involves potential risks including death. In addition to these surgical risks, the
risks associated with the implantation and use of a spinal cord stimulation system include:
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Undesirable changes in stimulation sensation and/or location.
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Uncomfortable changes in stimulation (over and/or under stimulation).
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Persistent post-surgical pain at hardware implantation sites.
