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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

Simulator configuration for EMC testing of a sample neurostimulator while exposed to HHMD emissions. The HHMD Support Grid was placed 1.5 cm above the neurostimulator.
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Figure 7: Simulator configuration for EMC testing of a sample neurostimulator while exposed to HHMD emissions. The HHMD Support Grid was placed 1.5 cm above the neurostimulator.

Mentions: The three sample neurostimulator devices were exposed to the magnetic field emissions from 32 sample HHMDs to assess the EMC among these devices and the HHMDs. The actual HHMDs were used rather than the WTMD simulator because the WTMD simulator was not able to produce the emissions of all HHMDs. The same setup from the WTMD EMC tests was used to support and create a level plane to test the neurostimulators. An additional plastic fixture was placed over the neurostimulator plane to create a testing plane for the exposures. This plane created a 1.5 cm separation distance between the HHMD and neurostimulator as seen in Fig (7).


Electromagnetic compatibility testing of implantable neurostimulators exposed to metal detectors.

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

Simulator configuration for EMC testing of a sample neurostimulator while exposed to HHMD emissions. The HHMD Support Grid was placed 1.5 cm above the neurostimulator.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 7: Simulator configuration for EMC testing of a sample neurostimulator while exposed to HHMD emissions. The HHMD Support Grid was placed 1.5 cm above the neurostimulator.
Mentions: The three sample neurostimulator devices were exposed to the magnetic field emissions from 32 sample HHMDs to assess the EMC among these devices and the HHMDs. The actual HHMDs were used rather than the WTMD simulator because the WTMD simulator was not able to produce the emissions of all HHMDs. The same setup from the WTMD EMC tests was used to support and create a level plane to test the neurostimulators. An additional plastic fixture was placed over the neurostimulator plane to create a testing plane for the exposures. This plane created a 1.5 cm separation distance between the HHMD and neurostimulator as seen in Fig (7).

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