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Abstract Background We studied the worst-case radiated radiofrequency (RF) susceptibility of automated external defibrillators (AEDs) based on the electromagnetic compatibility (EMC) requirements of a current standard for cardiac defibrillators, IEC 60601-2-4. Square wave modulation was used to mimic cardiac physiological frequencies of 1 - 3 Hz. Deviations from the IEC standard were a lower frequency limit of 30 MHz to explore frequencies where the patient-connected leads could resonate. Also testing up to 20 V/m was performed. We tested AEDs with ventricular fibrillation (V-Fib) and normal sinus rhythm signals on the patient leads to enable testing for false negatives (inappropriate "no shock advised" by the AED). Methods We performed radiated exposures in a 10 meter anechoic chamber using two broadband antennas to generate E fields in the 30 - 2500 MHz frequency range at 1% frequency steps. An AED patient simulator was housed in a shielded box and delivered normal and fibrillation waveforms to the AED's patient leads. We developed a technique to screen ECG waveforms stored in each AED for electromagnetic interference at all frequencies without waiting for the long cycle times between analyses (normally 20 to over 200 s). Results Five of the seven AEDs tested were susceptible to RF interference, primarily at frequencies below 80 MHz. Some induced errors could cause AEDs to malfunction and effectively inhibit operator prompts to deliver a shock to a patient experiencing lethal fibrillation. Failures occurred in some AEDs exposed to E fields between 3 V/m and 20 V/m, in the 38 - 50 MHz range. These occurred when the patient simulator was delivering a V-Fib waveform to the AED. Also, we found it is not possible to test modern battery-only-operated AEDs for EMI using a patient simulator if the IEC 60601-2-4 defibrillator standard's simulated patient load is used. Conclusions AEDs experienced potentially life-threatening false-negative failures from radiated RF, primarily below the lower frequency limit of present AED standards. Field strengths causing failures were at levels as low as 3 V/m at frequencies below 80 MHz where resonance of the patient leads and the AED input circuitry occurred. This plus problems with the standard's' prescribed patient load make changes to the standard necessary.

Abstract Background Magnetic resonance imaging (MRI) of patients with implanted cardiac pacemakers is generally contraindicated but some clinicians condone scanning certain patients. We assessed the risk of inducing unintended cardiac stimulation by measuring electric fields (E) induced near lead tips by a simulated MRI gradient system. The objectives of this study are to map magnetically induced E near distal tips of leads in a saline tank to determine the spatial distribution and magnitude of E and compare them with E induced by a pacemaker pulse generator (PG). Methods We mapped magnetically induced E with 0.1 mm resolution as close as 1 mm from lead tips. We used probes with two straight electrodes (e.g. wire diameter of 0.2 mm separated by 0.9 mm). We generated magnetic flux density (B) with a Helmholtz coil throughout 0.6% saline in a 24 cm diameter tank with (dB/dt) of 1 T/sec (1 kHz sinusoidal waveform). Separately, we measured E near the tip of leads when connected to a PG set to a unipolar mode. Measurements were non-invasive (not altering the leads or PG under study). Results When scaled to 30 T/s (a clinically relevant value), magnetically-induced E exceeded the E produced by a PG. The magnetically-induced E only occurred when B was coincident with or within 15 msec of implantable pacemaker's pulse. Conclusions Potentially hazardous situations are possible during an MR scan due to gradient fields. Unintended stimulation can be induced via abandoned leads and leads connected to a pulse generator with loss of hermetic seal at the connector. Also, pacemaker-dependent patients can receive drastically altered pacing pulses.

Abstract Background MRI induced heating on PM leads is a very complex issue. The widely varying results described in literature suggest that there are many factors that influence the degree of heating and that not always are adequately addressed by existing testing methods. Methods We present a wide database of experimental measurements of the heating of metallic wires and PM leads in a 1.5 T RF coil. The aim of these measurements is to systematically quantify the contribution of some potential factors involved in the MRI induced heating: the length and the geometric structure of the lead; the implant location within the body and the lead path; the shape of the phantom used to simulate the human trunk and its relative position inside the RF coil. Results We found that the several factors are the primary influence on heating at the tip. Closer locations of the leads to the edge of the phantom and to the edge of the coil produce maximum heating. The lead length is the other crucial factor, whereas the implant area does not seem to have a major role in the induced temperature increase. Also the lead structure and the geometry of the phantom revealed to be elements that can significantly modify the amount of heating. Conclusion Our findings highlight the factors that have significant effects on MRI induced heating of implanted wires and leads. These factors must be taken into account by those who plan to study or model MRI heating of implants. Also our data should help those who wish to develop guidelines for defining safe medical implants for MRI patients. In addition, our database of the entire set of measurements can help those who wish to validate their numerical models of implants that may be exposed to MRI systems.

The increasing use of shared, unlicensed spectrum bands by medical devices and nonmedical products highlights the need to address wireless coexistence to ensure medical device safety and effectiveness. This paper provides the first step to approximate the probability of a device coexisting in its intended environment by providing a generalized framework for modeling the environment. The application of this framework is shown through an 84-day spectrum survey of the 2.4–2.48 GHz industrial, scientific, and medical band in a hospital environment in the United States. A custom platform was used to monitor power flux spectral density and record received power. Channel utilization of three nonoverlapping channels of 20 MHz bandwidth—relative to IEEE 802.11 channels 1, 6, and 11—were calculated and fitted to a generalized extreme value distribution. Low channel utilization was observed ( $ <$10%) in the surveyed environment with sporadic occurrences of higher channel utilization ($ >$ 50%). Reported findings can be complementary to wireless coexistence testing. This paper can provide input to the development of a consensus standard for wireless device coexistence test methods and a consensus document focused on wireless medical device coexistence risk management. [ABSTRACT FROM PUBLISHER]

Background: We studied the worst-case radiated radiofrequency (RF) susceptibility of automated external defibrillators (AEDs) based on the electromagnetic compatibility (EMC) requirements of a current standard for cardiac defibrillators, IEC 60601-2-4. Square wave modulation was used to mimic cardiac physiological frequencies of 1-3 Hz. Deviations from the IEC standard were a lower frequency limit of 30 MHz to explore frequencies where the patient-connected leads could resonate. Also testing up to 20 V/m was performed. We tested AEDs with ventricular fibrillation (V-Fib) and normal sinus rhythm signals on the patient leads to enable testing for false negatives (inappropriate "no shock advised" by the AED).Methods: We performed radiated exposures in a 10 meter anechoic chamber using two broadband antennas to generate E fields in the 30-2500 MHz frequency range at 1% frequency steps. An AED patient simulator was housed in a shielded box and delivered normal and fibrillation waveforms to the AED's patient leads. We developed a technique to screen ECG waveforms stored in each AED for electromagnetic interference at all frequencies without waiting for the long cycle times between analyses (normally 20 to over 200 s).Results: Five of the seven AEDs tested were susceptible to RF interference, primarily at frequencies below 80 MHz. Some induced errors could cause AEDs to malfunction and effectively inhibit operator prompts to deliver a shock to a patient experiencing lethal fibrillation. Failures occurred in some AEDs exposed to E fields between 3 V/m and 20 V/m, in the 38 - 50 MHz range. These occurred when the patient simulator was delivering a V-Fib waveform to the AED. Also, we found it is not possible to test modern battery-only-operated AEDs for EMI using a patient simulator if the IEC 60601-2-4 defibrillator standard's simulated patient load is used.Conclusions: AEDs experienced potentially life-threatening false-negative failures from radiated RF, primarily below the lower frequency limit of present AED standards. Field strengths causing failures were at levels as low as 3 V/m at frequencies below 80 MHz where resonance of the patient leads and the AED input circuitry occurred. This plus problems with the standard's' prescribed patient load make changes to the standard necessary. [ABSTRACT FROM AUTHOR]

An in vitro study was undertaken to investigate the potential for cellular telephones to interfere with representative models of presently used ICDs. Digital cellular phones (DCPs) generate strong, amplitude modulated fields with pulse repetition rates near the physiological range sensed by the ICD as an arrhythmia. DCPs with Time Division Multiple Access (TDMA) pulsed amplitude modulation caused the most pronounced effect—high voltage firing or inhibition of pacing output of the ICDs. This electromagnetic interference (EMI) occurred only when the phones were within 2.3–5.8 cm of the ICD pulse generator that was submerged 0.5 cm in 0.18% saline. ICD performance always reverted to baseline when the cellular phones were removed from the immediate proximity of the ICD. Three models of ICDs were subjected to EMI susceptibility testing using two types of digital phones and one analog cellular phone, each operating at their respective maximum output power. EMI was observed in varying degrees from all DCPs. Inhibition of pacer output occurred in one ICD, and high voltage firing occurred in the two other ICDs, when a TDMA-11 Hz DCP was placed within 2.3 cm of the ICD. For the ICD that was most sensitive to delivering unintended therapy, inhibition followed by firing occurred at distances up to 5.8 cm. When a TDMA-50 Hz phone was placed at the minimum test distance of 2.3 cm, inhibition followed by firing was observed in one of the ICDs. EMI occurred most frequently when the lower portion of the monopole antenna of the cellular phone was placed over the ICD header. [ABSTRACT FROM AUTHOR]

Background: MRI induced heating on PM leads is a very complex issue. The widely varying results described in literature suggest that there are many factors that influence the degree of heating and that not always are adequately addressed by existing testing methods.Methods: We present a wide database of experimental measurements of the heating of metallic wires and PM leads in a 1.5 T RF coil. The aim of these measurements is to systematically quantify the contribution of some potential factors involved in the MRI induced heating: the length and the geometric structure of the lead; the implant location within the body and the lead path; the shape of the phantom used to simulate the human trunk and its relative position inside the RF coil.Results: We found that the several factors are the primary influence on heating at the tip. Closer locations of the leads to the edge of the phantom and to the edge of the coil produce maximum heating. The lead length is the other crucial factor, whereas the implant area does not seem to have a major role in the induced temperature increase. Also the lead structure and the geometry of the phantom revealed to be elements that can significantly modify the amount of heating.Conclusion: Our findings highlight the factors that have significant effects on MRI induced heating of implanted wires and leads. These factors must be taken into account by those who plan to study or model MRI heating of implants. Also our data should help those who wish to develop guidelines for defining safe medical implants for MRI patients. In addition, our database of the entire set of measurements can help those who wish to validate their numerical models of implants that may be exposed to MRI systems. [ABSTRACT FROM AUTHOR]

Exposure of patients with active implants (e.g. cardiac pacemakers and neurostimulators) to magnetic gradient fields (kHz range) during magnetic resonance imaging presents safety issues, such as unintended stimulation. Magnetically induced electric fields generate currents along the implant's lead, especially high at the distal tip. Experimental evaluation of the induced electric field was previously conducted. This study aimed to perform the same evaluation by means of computational methods, using two commercially available software packages (SemcadX and COMSOL Multiphysics). Electric field values were analyzed 1-3 mm from the distal tip. The effect of the two-electrode experimental probe was evaluated. The results were compared with previously published experimental data with reasonable agreement at locations more than 2-3 mm from the distal tip of the lead. The results were affected by the computational mesh size, with up to one order of magnitude difference for SEMCAD (resolution of 0.1 mm) compared to COMSOL (resolution of 0.5 mm). The results were also affected by the dimensions of the two-electrode probe, suggesting careful selection of the probe dimensions during experimental studies.

Background: Magnetic resonance imaging (MRI) of patients with implanted cardiac pacemakers is generally contraindicated but some clinicians condone scanning certain patients. We assessed the risk of inducing unintended cardiac stimulation by measuring electric fields (E) induced near lead tips by a simulated MRI gradient system. The objectives of this study are to map magnetically induced E near distal tips of leads in a saline tank to determine the spatial distribution and magnitude of E and compare them with E induced by a pacemaker pulse generator (PG)., Methods: We mapped magnetically induced E with 0.1 mm resolution as close as 1 mm from lead tips. We used probes with two straight electrodes (e.g. wire diameter of 0.2 mm separated by 0.9 mm). We generated magnetic flux density (B) with a Helmholtz coil throughout 0.6% saline in a 24 cm diameter tank with (dB/dt) of 1 T/sec (1 kHz sinusoidal waveform). Separately, we measured E near the tip of leads when connected to a PG set to a unipolar mode. Measurements were non-invasive (not altering the leads or PG under study)., Results: When scaled to 30 T/s (a clinically relevant value), magnetically-induced E exceeded the E produced by a PG. The magnetically-induced E only occurred when B was coincident with or within 15 msec of implantable pacemaker's pulse., Conclusions: Potentially hazardous situations are possible during an MR scan due to gradient fields. Unintended stimulation can be induced via abandoned leads and leads connected to a pulse generator with loss of hermetic seal at the connector. Also, pacemaker-dependent patients can receive drastically altered pacing pulses.

Nondestructive methods were used to evaluate marketed fiber-optic endoscopes (intended for simple viewing) for fluorescence recording. Our application is for optical recording from the heart. For one angioscope, we measured a focal length of 0.33 mm, a field of view of 45 degrees, an aperture of 0.26 mm, and an efficiency of 43%. We calculated that the angioscope would give a signal-to-noise ratio of 1.0 for a cardiac action potential, if its field of view were divided into a nine-pixel array (for safe continuous illumination). Our methods are useful in designing and evaluating fluorescence fiber-optic systems with superior signal quality and spatial resolution.