This is an electronic control system designed to drive small power instrumentation in a wide variety of surgical applications. It supports several surgical hand instruments, offers control of an irrigation pump, and can be controlled via foot pedal. The Console has an LCD configuration, settings, and status.
Pivot provided full turnkey design services for this product and supports ongoing manufacturing. We started from the customer’s concept and high-level requirements for the device, generating industrial design concepts; then performed detailed electrical, mechanical, and software design with multiple stages of prototypes. Pivot worked with the client on detailing technical and performance requirements, including usability requirements. Pivot executed design and documentation activities in compliance with 60601-1 and associated FDA software life cycle requirements, then performed technical verification against requirements, supported customer validation, and formal certification activities.