Fully automated Tier 3 analysis of radio frequency (RF)-induced local power deposition at the electrodes of implantable devices for millions of excitations. IMAnalytics and MRIxViP are qualified by the FDA for MRI safety evaluations.
Contents IMAnalytics is a novel software platform solution for the comprehensive safety evaluation of implantable devices. The module is designed to characterize the RF-induced heating at the distal electrodes of implantable devices, as well as the voltage at the lead terminals of the pulse generator, using the Tier 3 approach as defined in ISO 10974, and to extract the RF-induced E-field in a region of interest for use in the Tier 2 approach of ISO 10974, or for scaling of ASTM F2182 phantom measurements.
Applications MR-safety with respect to RF-induced heating of structures such as leads for cardiac pacing/sensing, implantable cardioverter defibrillator (ICD), spinal cord stimulation (SCS), and deep-brain stimulation (DBS) systems.
Characteristics
  • Fully compatible with the exposure field libraries MRIxViP of the IT’IS Foundation.
  • Preprocessing of terabytes of electromagnetic (EM) field data from many combinations of birdcage types, anatomies, landmark positions and implant routing paths.
  • Direct input of the transfer function of the implanted device from piX system.
  • Different polarizations and exposure conditions by sweeping through many independent excitation settings of the I and Q channels.
  • Efficient evaluation of millions of exposure scenarios and extraction of relevant statistical data on deposited power.
  • Evaluation of deposited power or induced voltage at different operating modes (normal, first level controlled).
  • Different limits defined in terms of whole-body specific absorption rate (SAR), partial-body SAR, head SAR or B1 field values.

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