Document Reference: ENG-UMAN-000731
Revision: 5.00
Page 57 of 61
16
Saluda Medical Evoke System Limited Warranty
Saluda Medical provides the following assurance to a patient who receives a Saluda
Medical Evoke System. The Evoke System includes a Closed-Loop Stimulator (referred to as
the CLS), temporary and permanent leads, external accessories and single-use accessories,
hereafter referred to as Components.
16.1
Closed-Loop Stimulator
Saluda Medical warrants that the CLS will function within normal tolerances and be free
from defects in materials or workmanship for a period of five (5) years from the date of
implantation of the CLS. This limited warranty does not apply to the leads, or surgical
accessories used with the CLS.
Should the CLS fail to function within normal tolerances within five (5) years from the date
of implantation, Saluda Medical will replace the CLS with a functionally comparable
replacement. The limited warranty for the replacement CLS will last for five (5) years from
the date of implantation of the original CLS.
CLS battery depletion will occur over time and is not considered to be a defect in materials
or workmanship. Depletion of the battery will depend on the settings used to meet the
patient’s requirements for neurostimulation. Hence, no claim is made that the CLS battery
will last the entire duration of this limited warranty.
16.2
Leads
Saluda Medical warrants that the Evoke leads are free from defects in materials or
workmanship within a period of one (1) year, starting from their date of implantation. This
limited warranty does not apply to the surgical accessories used with the lead.
Should a lead fail to function within normal tolerances within one (1) year after the date of
its implantation, Saluda Medical will replace the lead with a functionally comparable
replacement lead made by Saluda Medical. The limited warranty for the replacement lead
will last only for one (1) year from the date of implantation of the original lead.
16.3
Externals
Saluda Medical warrants that the Evoke Pocket Console (referred to as the EPC) and the
Evoke Charger will function within normal tolerances and be free from defects in materials
or workmanship within a period of one (1) year from the date of purchase.
Should an EPC or charger fail to function within normal tolerance within one (1) year after
the date of purchase, Saluda Medical will replace the device with a functionally comparable
replacement. The limited warranty for the replacement EPC or charger will last only for one
(1) year from the date of purchase of the original device.
16.4
Claims
The following conditions and limitations are applicable to claims under this limited
warranty:
1.
All registration forms must be completed and returned to Saluda Medical within
thirty (30) days of implantation of the CLS.
2.
The CLS must be implanted prior to its “use by” date.
3.
Failure of components must be confirmed by Saluda Medical.
4.
The replaced CLS must be returned to Saluda Medical (or Saluda Medical’s
authorized agent) within thirty (30) days after explant and shall be the property of
