Testing the Immunity of Active Implantable Medical Devices to CW Magnetic Fields up to 1 MHz by an Immersion Method

Buzduga, V.; Witters, Donald; Casamento, Jon P.; Kainz, Wolfgang

doi:10.1109/tbme.2007.893502

Cited by 18 publications

(4 citation statements)

References 2 publications

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“…The coils were connected in parallel. This device was originally designed for producing a spatially uniform field to test implanted medical devices in saline for susceptibility to electromagnetic interference [ 10 ]. The coil was driven by current from a transconductance amplifier (Clarke-Hess, Medford, NY 11763, USA).…”

Section: Methodsmentioning

confidence: 99%

In-vitro mapping of E-fields induced near pacemaker leads by simulated MR gradient fields

Bassen

Mendoza

2009

BioMedical Engineering OnLine

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BackgroundMagnetic 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).MethodsWe 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).ResultsWhen 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.ConclusionsPotentially 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.

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Section: Methodsmentioning

confidence: 99%

In-vitro mapping of E-fields induced near pacemaker leads by simulated MR gradient fields

Bassen

Mendoza

2009

BioMedical Engineering OnLine

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“…By measuring this delay and the pulse level, it is possible to monitor the functioning of the implant. If a variation of more or less 20 % on the delay or a decrease of 50 % of the pulse amplitude is observed [22], it is considered as a malfunction (see Fig. 7).…”

Section: A Test Protocolmentioning

confidence: 99%

Testing immunity of active implantable medical devices to industrial magnetic field environments

Hammen

Pichon

Bihan

et al. 2022

2022 International Symposium on Electromagnetic Compatibility – EMC Europe

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The aim of this work is to develop a new method for testing the immunity of active implantable medical devices to low frequency industrial magnetic fields (between 50 Hz and 50 kHz) up to the high occupational exposure limits. It is based on an experimental approach using a specific test bench with the capability of reproducing real exposure situations and testing multiple orientations between the magnetic field and the device. The solution adopted was to combined 3 concentric Helmholtz coils on 3 perpendicular axes. The test bench was designed using a numerical simulation software. A good agreement between the numerical model and the test bench characterisation was observed. The determination of the interference threshold of a pacemaker as a function of the frequency (50 Hz to 50 kHz) is given as an example. The experimental results show between 50 Hz and 400 Hz an interference threshold between the public and the occupational exposure limits. Between 400 Hz and 50 kHz, no malfunction below the occupational high exposure limits was observed. The encountered malfunctions are completely reversible. It also appears that the occurrence of interferences strongly depends on the magnetic field orientation. This new test method will be applied to several pacemakers and could be used or adapted to other active medical implants such as cardioverter defibrillators or neurostimulators.

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“…Technology has been playing an important role in the area of medical devices for patient diagnosis, monitoring and treatment consisting of x-ray apparatus, magnetic resonance imaging (MRI), surgical and other medical instruments. Given a recent paradigm shift, emerging medical devices are not only composed of passive devices controlled by human but are moving towards more complex cyber-physical systems consisting of active devices [50], [51], including computational embedded systems with sensors and actuators to analyze and control the physical processes. Ultimately, cyber-physical systems transform how we interact with the physical world, where each system requires different level of security based on the sensitivity of the information and control system.…”

Section: Health Care Securitymentioning

confidence: 99%

Cyber-physical systems: A security perspective

Konstantinou

Maniatakos

Saqib

et al. 2015

2015 20th IEEE European Test Symposium (ETS)

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A cyber-physical system (CPS) is a composition of independently interacting components, including computational elements, communications and control systems. Applications of CPS institute at different levels of integration, ranging from nation-wide power grids, to medium scale, such as the smart home, and small scale, e.g. ubiquitous health care systems including implantable medical devices. Cyber-physical systems primarily transmute how we interact with the physical world, with each system requiring different levels of security based on the sensitivity of the control system and the information it carries. Considering the remarkable progress in CPS technologies during recent years, advancement in security and trust measures is much needed to counter the security violations and privacy leakage of integration elements. This paper focuses on security and privacy concerns at different levels of the composition and presents system level solutions for ensuring the security and trust of modern cyber-physical systems.978-1-4799-7603-4/15/$31.00

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Testing the Immunity of Active Implantable Medical Devices to CW Magnetic Fields up to 1 MHz by an Immersion Method

Cited by 18 publications

References 2 publications

In-vitro mapping of E-fields induced near pacemaker leads by simulated MR gradient fields

In-vitro mapping of E-fields induced near pacemaker leads by simulated MR gradient fields

Testing immunity of active implantable medical devices to industrial magnetic field environments

Cyber-physical systems: A security perspective

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