Evoke Clinical Interface (CI) - Implantable electrical stimulation device management software

Intended purpose

The Evoke System is a spinal cord stimulation (SCS) system which stimulates the nerves in the spinal cord, measures their responses and automatically adjusts the stimulation level accordingly. It is intended to aid in the management of chronic intractable pain of the lower back and/or legs. The Evoke Clinical Interface (CI) is an off-the-shelf tablet computer with preinstalled Evoke Clarity Programming Application (CPA) software, used by the clinician to adjust the therapy settings of the spinal cord stimulator, preinstalled Evoke Firmware Upgrade Application (FUA) software, which is intended to allow the upgrade of the spinal cord stimulator with new firmware, and preinstalled Evoke RECAP Viewer software which allows analysis of the data generated by the system

Functional description

The Evoke Clinical Interface (CI) is an off-the-shelf tablet computer that connects to the Evoke Clinical System Transceiver (CST) via a USB port to provide wireless communication with the spinal cord stimulator and includes the following software applications: the Evoke Clarity Programming Application (CPA), the Evoke RECAP Viewer and the Evoke Firmware Upgrade Application (FUA).