title: Implantable cardiac pacemaker electromagnetic compatibility testing in a novel security system simulator.
abstract: This paper describes a novel simulator to perform electromagnetic compatibility (EMC) tests for active implantable medical devices (AIMDs) with electromagnetic fields emitted by security systems. The security system simulator was developed in response to over 100 incident reports over 17 years related to the interference of AIMD's with security systems and the lack of a standardized test method. The simulator was evaluated regarding field homogeneity, signal distortion, and maximum magnetic field strength levels. Small three-axis probes and a three-axis scanning system were designed to determine the spatial and temporal characteristics of the fields emitted by 12 different types of walk through metal detectors (WTMDs). Tests were performed on four implanted pacemakers with a saline phantom and correlated to a newly developed test method performed "in air" (without the phantom). Comparison of the simulator thresholds with tests performed in real WTMDs showed that the simulator is able to mimic the pacemaker interference. The interference thresholds found in the simulator indicate that pulsed magnetic fields are more likely to cause interference in pacemakers than sinusoidal fields. The security system simulator will help biomedical engineers, manufacturers of medical devices, and manufacturers of security systems to identify incompatible combinations of WTMDs and AIMDs early in the development stage.
authors.affiliation: Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20851, USA. wxk@cdrh.fda.gov
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kainz
authors.forename: Jon P
authors.initials: JP
authors.lastname: Casamento
authors.forename: Paul S
authors.initials: PS
authors.lastname: Ruggera
authors.forename: Dulciana D
authors.initials: DD
authors.lastname: Chan
authors.forename: Donald M
authors.initials: DM
authors.lastname: Witters
mesh_terms: D004574:Electromagnetic Fields; D019544:Equipment Failure Analysis / Q000295:instrumentation* / Q000379:methods*; D010138:Pacemaker, Artificial; D019736:Prostheses and Implants; D012637:Security Measures