Work completed as an employee of BCA.
Our client wanted to design a cardiac ablation system that displays the temperature of the tissue being treated, not just the tip of the catheter. In order to obtain the CE mark necessary for first-in-man testing the product was compliant with IEC 60601 and passed all impact, ingress, and vibration tests.
I designed the modification for an off-the-shelf enclosure that was selected because of impact and ingress protection specs. A custom cable was designed to house a transition circuit board. The over molded portion of the cable needed to have soft edges so not to catch on other equipment or in the operating room. All design documentation for modifications and assembly was tracked in a design history file.