Document Reference: ENG-UMAN-000731
Revision: 5.00
Page 10 of 61
software installed and affect the delivery of therapy for patients. Any required software
installations shall be supported directly by Saluda Medical representatives or via detailed
instructions concerning specific installations as required.
4.2.2
Unsupported hardware
Do not connect any device to the Evoke CI other than the supplied: keyboard, charger
and Evoke CST. Do not connect the Evoke CST to any device other than a Saluda Medical
supplied Evoke CI. Unsupported hardware could interfere in unpredictable ways with the
programming software installed and affect the delivery of therapy for patients.
For data file extraction it is permissible to use an external memory stick that has passed a
screening check by an up-to-date anti-virus software application, but no files should be
transferred onto the CI unless otherwise instructed by Saluda Medical to do so.
4.2.3
Shared IT networks
Network connection is only permitted to secure networks. Connecting to unsecure
networks could lead to the modification of CI System or software that interfere in
unpredictable ways with the programming software installed and affect the delivery of
therapy for patients.
4.2.4
Modification of the programming software
Do not attempt to modify the Clinical Programming Application (CPA) software which
comes preinstalled on the CI for the programming of Saluda Medical neurostimulators. Any
deletion or modification of files associated with the CPA could adversely affect the
system's ability to effectively adjust therapy for patients.
Required software upgrades will be supported directly by Saluda Medical representatives
or via detailed instructions concerning specific upgrades as required. Additionally, any
stimulator software upgrades will be fully supported by Saluda Medical representatives –
do not attempt to modify the stimulator software without Saluda Medical’s instruction.
4.2.5
Non-sterile components
DO NOT STERILIZE either the CI or CST; these items are not to be sterilized and doing so
could irrevocably damage the devices.
4.2.6
Clinical staff training
Clinical staff using the CI/CST to program the Evoke SCS System must be adequately
trained in the programming of SCS systems generally. Additionally, clinical staff
programming the Evoke SCS System should have read the instructions within this manual. A
poor understanding of the programming of SCS systems generally and the Evoke System
specifically could cause unpleasant or painful stimuli for patients.
