Document Reference: ENG-UMAN-000731
Revision: 5.00
Page 9 of 61
All Evoke sterilized components are single use only and should not be re-sterilized
or reused, because of the risk of infection and device malfunction.
Please observe the storage conditions printed on the labels of each component –
particularly storage and transport temperature, which varies between components
– as inadequate storage could have a negative impact on shelf-life and sterility.
Please observe the expiration dates printed on the labels and return any expired
product to Saluda Medical because of the risk of infection.
If the packaging appears to be damaged, please return it to Saluda Medical for
replacement.
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
Patients should be advised to carry and hold their accessories carefully to protect
them from striking hard surfaces or being dropped.
Patients should be advised to keep their accessories dry and never immerse them in
water.
Patients should be advised to not plug the Charger into outlets that are in humid
environments – such as a bathroom – or near water.
If patients need to clean their accessories, refer them to the Evoke Instructions for
Use.
Avoid prolonged skin contact of the external system components (lead adapter,
lead adapter cable, lead adapter extension, eCLS, EPC and Charger and charging
coil). Place clothing or dressings between skin and external system components.
Disposal of the stimulator, EPC and Charger
The CLS, eCLS, EPC and Charger contain batteries that could explode if they are
thrown into a fire.
The CLS, eCLS, EPC and Charger should be returned to Saluda Medical.
Disposal of sharps and explanted implants
Please dispose of any sharps and medical waste according to your usual procedures.
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
The components of the Evoke System are not intended to be modified by users or
surgeons in any way.
4.2.1
Unsupported software applications
Do not load software applications onto the Evoke CI. The Evoke CI has all the necessary
software required to interact with and program the Evoke SCS System from Saluda
Medical. Other applications could interfere in unpredictable ways with the programming
