Limits...
Electromagnetic compatibility testing of implantable neurostimulators exposed to metal detectors.

Seidman SJ, Kainz W, Casamento J, Witters D - Open Biomed Eng J (2010)

Bottom Line: This paper presents results of electromagnetic compatibility (EMC) testing of three implantable neurostimulators exposed to the magnetic fields emitted from several walk-through and hand-held metal detectors.Emission measurements were performed on all HHMDs and WTMDs and summary data is presented.The results suggest that worst case situations for EMC testing are hard to predict and testing all major medical device modes and setting parameters are necessary to understand and characterize the EMC of AIMDs.

View Article: PubMed Central - PubMed

Affiliation: Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), 10903 New Hampshire Ave, Silver Spring, MD20910, USA.

ABSTRACT
This paper presents results of electromagnetic compatibility (EMC) testing of three implantable neurostimulators exposed to the magnetic fields emitted from several walk-through and hand-held metal detectors. The motivation behind this testing comes from numerous adverse event reports involving active implantable medical devices (AIMDs) and security systems that have been received by the Food and Drug Administration (FDA). EMC testing was performed using three neurostimulators exposed to the emissions from 12 walk-through metal detectors (WTMDs) and 32 hand-held metal detectors (HHMDs). Emission measurements were performed on all HHMDs and WTMDs and summary data is presented. Results from the EMC testing indicate possible electromagnetic interference (EMI) between one of the neurostimulators and one WTMD and indicate that EMI between the three neurostimulators and HHMDs is unlikely. The results suggest that worst case situations for EMC testing are hard to predict and testing all major medical device modes and setting parameters are necessary to understand and characterize the EMC of AIMDs.

No MeSH data available.


Related in: MedlinePlus

Example of HHMD emissions from a vertical-handlenormal plane (front view). Axes coordinates in cm.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC2864430&req=5

Figure 11: Example of HHMD emissions from a vertical-handlenormal plane (front view). Axes coordinates in cm.

Mentions: Emission maps from a sample HHMD is shown in Figs. (9-11). All except one HHMD emitted CW waveforms with frequencies ranging from 10 kHz to 1856 kHz. The pulsed waveform that HHMD-M emitted was unique among the samples. The maximum field strengths emitted by the other HHMDs ranged from 2.1 to 67.3 A/m, with HHMD-M emitting significantly higher magnetic field strengths of over 600A/m. The high magnetic field emissions from HHMD-M exceeded the range of the 1709.1 ERM probe at 2.5 cm from the surface. The emissions were then measured using an 1850.002 ERM probe at 2 cm measuring 600 A/m. The emission data for all HHMDs is summarized in Table 2.


Electromagnetic compatibility testing of implantable neurostimulators exposed to metal detectors.

Seidman SJ, Kainz W, Casamento J, Witters D - Open Biomed Eng J (2010)

Example of HHMD emissions from a vertical-handlenormal plane (front view). Axes coordinates in cm.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2864430&req=5

Figure 11: Example of HHMD emissions from a vertical-handlenormal plane (front view). Axes coordinates in cm.
Mentions: Emission maps from a sample HHMD is shown in Figs. (9-11). All except one HHMD emitted CW waveforms with frequencies ranging from 10 kHz to 1856 kHz. The pulsed waveform that HHMD-M emitted was unique among the samples. The maximum field strengths emitted by the other HHMDs ranged from 2.1 to 67.3 A/m, with HHMD-M emitting significantly higher magnetic field strengths of over 600A/m. The high magnetic field emissions from HHMD-M exceeded the range of the 1709.1 ERM probe at 2.5 cm from the surface. The emissions were then measured using an 1850.002 ERM probe at 2 cm measuring 600 A/m. The emission data for all HHMDs is summarized in Table 2.

Bottom Line: This paper presents results of electromagnetic compatibility (EMC) testing of three implantable neurostimulators exposed to the magnetic fields emitted from several walk-through and hand-held metal detectors.Emission measurements were performed on all HHMDs and WTMDs and summary data is presented.The results suggest that worst case situations for EMC testing are hard to predict and testing all major medical device modes and setting parameters are necessary to understand and characterize the EMC of AIMDs.

View Article: PubMed Central - PubMed

Affiliation: Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), 10903 New Hampshire Ave, Silver Spring, MD20910, USA.

ABSTRACT
This paper presents results of electromagnetic compatibility (EMC) testing of three implantable neurostimulators exposed to the magnetic fields emitted from several walk-through and hand-held metal detectors. The motivation behind this testing comes from numerous adverse event reports involving active implantable medical devices (AIMDs) and security systems that have been received by the Food and Drug Administration (FDA). EMC testing was performed using three neurostimulators exposed to the emissions from 12 walk-through metal detectors (WTMDs) and 32 hand-held metal detectors (HHMDs). Emission measurements were performed on all HHMDs and WTMDs and summary data is presented. Results from the EMC testing indicate possible electromagnetic interference (EMI) between one of the neurostimulators and one WTMD and indicate that EMI between the three neurostimulators and HHMDs is unlikely. The results suggest that worst case situations for EMC testing are hard to predict and testing all major medical device modes and setting parameters are necessary to understand and characterize the EMC of AIMDs.

No MeSH data available.


Related in: MedlinePlus