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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

Typical neurostimulator EMC testing with HHMDs occurred with the HHMD horizontal to the testing surface (not shown). Another orientation included the tip touching the testing plane and the HHMD axis perpendicular to the testing surface is shown above.
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Figure 8: Typical neurostimulator EMC testing with HHMDs occurred with the HHMD horizontal to the testing surface (not shown). Another orientation included the tip touching the testing plane and the HHMD axis perpendicular to the testing surface is shown above.

Mentions: The active HHMD was then placed in one corner of the grid and moved in 3 cm intervals over the entire surface. The HHMD was held for a duration of 10 seconds in each location. Interference behavior was observed and recorded at each point. A quick sweep (1 second stop at each location instead of 10 seconds) was also performed with the HHMD rotated 90, 180, and 270 degrees, as well as with the tip touching the testing plane and the HHMD axis perpendicular to the testing surface (see Fig. (8)) to see if different orientations of the HHMD might result in interference of the neurostimulator.


Electromagnetic compatibility testing of implantable neurostimulators exposed to metal detectors.

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

Typical neurostimulator EMC testing with HHMDs occurred with the HHMD horizontal to the testing surface (not shown). Another orientation included the tip touching the testing plane and the HHMD axis perpendicular to the testing surface is shown above.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 8: Typical neurostimulator EMC testing with HHMDs occurred with the HHMD horizontal to the testing surface (not shown). Another orientation included the tip touching the testing plane and the HHMD axis perpendicular to the testing surface is shown above.
Mentions: The active HHMD was then placed in one corner of the grid and moved in 3 cm intervals over the entire surface. The HHMD was held for a duration of 10 seconds in each location. Interference behavior was observed and recorded at each point. A quick sweep (1 second stop at each location instead of 10 seconds) was also performed with the HHMD rotated 90, 180, and 270 degrees, as well as with the tip touching the testing plane and the HHMD axis perpendicular to the testing surface (see Fig. (8)) to see if different orientations of the HHMD might result in interference of the neurostimulator.

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