Implant Safety Evaluation at IT'IS – Episode I: Generation of the piX model

Efficient and accurate generation of the piece-wise excitation model for both heating and induced voltage demonstrated by using the newly developed universal validation device SAIMD-U

Today, we have published Episode I of our new video series, explaining how we determine the radiofrequency (RF) response of active implantable medical devices (AIMD) for both heating and voltage under magnetic resonance imaging (MRI) exposure in the same setup. This efficient yet rigorous assessment has become possible thanks to the latest instrumentation developed jointly with our longstanding partner ZMT. The video demonstrates usage of the new SAIMD-U reference device that has been specifically developed for the comprehensive verification of the evaluation instrumentation (birdcage simulator, phantom, liquid, field and temperature sensors) and the applied procedure to evaluate MR safety of AIMD.

The device resembles an actual active medical implant in that it consists of a long flexible lead and an integrated port for terminal voltage measurement. The deposited power and terminal voltage piecewise excitation (piX) models of the SAIMD-U are acquired with the latest piX and RF-over-Fiber probes, and compared to the known target values, which were obtained via verified and validated finite-difference time-domain (FDTD) simulations. As demonstrated, the determination of the piX model of any AIMD in a validated assessment system has never been easier!