Document Reference: ENG-UMAN-000731
Revision: 5.00
Page 58 of 61
Saluda Medical.
5.
Replaced Components must be returned to Saluda Medical (or Saluda Medical’s
authorized agent) within thirty (30) days after discovery of its failure and shall be
the property of Saluda Medical.
6.
For the rechargeable CLS and as described in the relevant surgical and patient
manuals, the battery in the CLS must not be over-discharged.
7.
This limited warranty does not include failures caused by:
a.
Attaching components or equipment to the Saluda Medical Evoke System,
which are not supplied or permitted by Saluda Medical.
b.
Accident, misuse, abuse, negligence or the patient’s failure to operate the
Evoke System according to the labelling and instructions for use provided.
c.
Unapproved attempts to repair, maintain or modify the Evoke System by the
patient or any unauthorized third party.
16.5
Limitations
This warranty is limited to its stated terms. Specifically:
1.
This limited warranty applies only to a patient in whom the CLS was implanted and
no other person or entity.
2.
Saluda Medical accepts no liability regarding components reused, reprocessed or
re-sterilized and makes no warranties, express or implied, including but not limited
to merchantability or fitness for a particular purpose.
Except as specified in this limited warranty, Saluda Medical is not responsible for any
damages (whether direct, indirect, incidental or consequential) based on any defect, failure
or malfunction of the Components, whether the claim is based on warranty, contract, tort
or otherwise.