REAL WORLD EMI/RFI/ESD TESTING OF AN LVAD SYSTEM

Abstract

PURPOSE: While designing new products, engineers look to standards to develop the envelope of the project. While these specifications help in determining design goals, the real world often has more strenuous requirements than any specification can foresee. METHODS: Evaluations were made of systems that a typical patient might encounter that emit EMI, RFI as well as ESD. The VAD system was exposed to these systems and the levels of EMI, RFI, and ESD were measured and the effects on the device analyzed. The system was exposed to the EMI/RFI of a fully responding fire station and the inside of an ambulance. The VAD system passed through different types of anti-theft systems, was exposed to household appliances and cellular telephone systems. Finally, the VAD systems received electrostatic shocks applied to various parts of the VAD system and were passed through current and next generation security systems as used in airports. RESULTS: Development of the MicroMed DeBakey VAD system began with close adherence to international specifications as well as systems that the patient might encounter in his/her everyday world. The MicroMed VAD system functioned properly throughout the testing performed. CONCLUSION: With the rise of complex electronic control systems for VAD products, close attention must be paid not only to medical device standards, but to devices and systems that a patient might encounter that were designed to different standards or to no standards at all. The design of a successful device requires that the control electronics be designed for these environments, rather than attempting to shield susceptible electronics from these EMI/RFI/ESD sources.