Overview

Problem Statement

This subsystem was used within a dialysis machine. The assembly was primarily flexible PVC components assembled together and held in place on a thermo-formed tray. This assembly was gamma sterilized and used within the dialysis cycler.

Challenges

Many components were blood contacting, which led to biocompatibility testing. Tubes must not kink or dent during shipping tests. Tubes must not tangle upon use, so coiling was critical. Leaks are absolutely zero tolerance and any issues must be caught on the production line. Lots of components require lots of project management.

Results

This design proved viable and is currently in use.