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Assessment of Electromagnetic Interference with Active Cardiovascular Implantable Electronic Devices (CIEDs) Caused by the Qi A13 Design Wireless Charging Board

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Electromagnetic interference is a concern for people wearing cardiovascular implantable electronic devices (CIEDs). The aim of this study was to assess the electromagnetic compatibility between CIEDs and the magnetic field of a common wireless charging technology. To do so the voltage induced in CIEDs by Qi A13 design magnetic fields were measured and compared with the performance limits set by ISO 14117. In order to carry this out a measuring circuit was developed which can be connected with unipolar or bipolar pacemaker leads. The measuring system was positioned at the four most common implantation sites in a torso phantom filled with physiological saline solution. The phantom was exposed by using Helmholtz coils from 5 μT to 27 μT with 111 kHz sine-bursts or by using a Qi A13 design wireless charging board (Qi-A13-Board) in two operating modes “power transfer” and “pinging”. With the Helmholtz coils the lowest magnetic flux density at which the performance limit was exceeded is 11 μT. With the Qi-A13-Board in power transfer mode 10.8% and in pinging mode 45.7% (2.2% at 10 cm distance) of the performance limit were reached at maximum. In neither of the scrutinized cases, did the voltage induced by the Qi-A13-Board exceed the performance limits.
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Int. J. Environ. Res. Public Health 2015, 12, 5886-5904; doi:10.3390/ijerph120605886
International Journal of
Environmental Research and
Public Health
ISSN 1660-4601
www.mdpi.com/journal/ijerph
Article
Assessment of Electromagnetic Interference with Active
Cardiovascular Implantable Electronic Devices (CIEDs) Caused
by the Qi A13 Design Wireless Charging Board
Tobias Seckler *, Kai Jagielski and Dominik Stunder
The Research Center for Bioelectromagnetic Interaction (FEMU), Institute and Out-patient Clinic of
Occupational Medicine, RWTH Aachen University, Pauwelsstr 30, 52074 Aachen, Germany;
E-Mails: jagielski@femu.rwth-aachen.de (K.J.); stunder@femu.rwth-aachen.de (D.S.)
* Author to whom correspondence should be addressed; E-Mail: seckler@femu.rwth-aachen.de;
Tel.: +49-241-80-35149; Fax: +49-241-80-82636.
Academic Editor: Martin Röösli
Received: 24 March 2015 / Accepted: 22 May 2015 / Published: 27 May 2015
Abstract: Electromagnetic interference is a concern for people wearing cardiovascular
implantable electronic devices (CIEDs). The aim of this study was to assess the
electromagnetic compatibility between CIEDs and the magnetic field of a common
wireless charging technology. To do so the voltage induced in CIEDs by Qi A13 design
magnetic fields were measured and compared with the performance limits set by
ISO 14117. In order to carry this out a measuring circuit was developed which can be
connected with unipolar or bipolar pacemaker leads. The measuring system was positioned
at the four most common implantation sites in a torso phantom filled with physiological
saline solution. The phantom was exposed by using Helmholtz coils from 5 µT to 27 µT
with 111 kHz sine-bursts or by using a Qi A13 design wireless charging board
(Qi-A13-Board) in two operating modes “power transfer” and “pinging”. With the
Helmholtz coils the lowest magnetic flux density at which the performance limit was
exceeded is 11 µT. With the Qi-A13-Board in power transfer mode 10.8% and in pinging
mode 45.7% (2.2% at 10 cm distance) of the performance limit were reached at maximum.
In neither of the scrutinized cases, did the voltage induced by the Qi-A13-Board exceed the
performance limits.
OPEN ACCESS
Int. J. Environ. Res. Public Health 2015, 12 5887
Keywords: intermediate frequency magnetic fields; pacemaker; defibrillator; electromagnetic
interference; wireless charging; wireless power transfer; Qi A13 design; performance limits;
EMF risk assessment
1. Introduction
Wireless power transfer (WPT) is an increasingly used strategy to improve user convenience and
mobility for electrical devices. WPT refers to a number of different technologies for transmitting
power subdivided into non-radiative techniques using capacitive or inductive coupling, or radiative
techniques such as microwaves or laser beam.
The WPT standard ‘Qi’ uses inductive coupling for power transfer from a base station to a mobile
device. The transmitter coil in the base station generates a magnetic field which induces a voltage in
the receiver coil of the mobile device. A new design within the Qi standard is the A13 application
which has been developed for operation in the automotive environment to wirelessly charge devices,
e.g., the battery of the drivers’ smartphone [1].
The investigated Qi A13 design wireless charging board (Qi-A13-Board) utilizes a linear array of
three rectangular shaped coils (53 × 45 mm) placed below a touch electrode. The Qi-A13-Board
operates at the intermediate frequency of 111 kHz in either an idle state or in the power transfer mode.
In the idle state the board issues sequential pings on each of its three coils in order to detect if a
receiver is present. This pinging mode can be activated by objects placed on the top of the
capacitance-based touch electrode and terminates if no answer is received. Once a receiver has been
recognized each of the coils is scanned to determine which coil is best coupled with the receiver.
The selected coil is then energized for power transfer with a maximum delivered power of 5 W (power
transfer mode). However, the actual level of the transferred power depends on the receiver (mobile
device) requirements [1,2].
With the magnetic field emission due to the inductive coupling, there arises the question of the
safety to humans with cardiovascular implantable electronic devices (CIED) as electromagnetic
interference (EMI) can result in life-threatening situations [3–5]. Devices with sensing capabilities
such as permanent pacemakers (PPMs) or implantable cardioverter-defibrillators (ICDs) are especially
susceptible to electromagnetic fields in the intermediate frequency range [6,7], because of potential
misinterpretation of induced voltages as cardiac signals. Safety considerations have become more and
more important as the number of new implantations of PPMs and ICDs increases every year as an
annual European survey shows [8–11]. In 61 countries worldwide, just in 2009, over 1.3 million PPMs
and ICDs were implanted, mostly utilizing bipolar leads (in Europe and the USA more than 99%) [12].
Guidelines for the protection of humans exposed to electric, magnetic or electromagnetic fields
(EMF) such as established by the International Commission on Non-Ionizing Radiation Protection
(ICNIRP) [13,14] or by the International Committee on Electromagnetic Safety (ICES) [15,16]
do not consider product performance of medical devices. Therefore compliance with these guidelines
may not necessarily preclude interference and EMI with CIED may occur below the recommended
reference levels [14]. Furthermore, a current review reasoned concerns about sufficiency of these
Int. J. Environ. Res. Public Health 2015, 12 5888
guidelines to protect CIEDs from hazardous interference by WPT and therefore recommended that
additional research is required [17].
Electromagnetic compatibility (EMC) of CIEDs is addressed by the international standard
ISO 14117 [18]. This standard sets performance limits up to 3 GHz with the objective to prevent harm
due to EMF, whether through malfunction, damage or heating of the device. Malfunctions from
sensing EMF as cardiac signals require the lowest performance limits given by this standard.
The limits rise linearly in the concerning frequency range (3 kHz to 167 kHz) and distinguish between
unipolar and bipolar leads. To evaluate EMC performance three general test methodologies are
specified: test signal one is a continuous sinusoidal wave with a frequency between 16.6 Hz and
1 kHz; test signal two is a modulated signal, carrier frequency, between 1 kHz and 150 kHz and
switched to create 100 ms burst; test signal three is a modulated signal, carrier frequency,
between 150 kHz and 10 MHz, with the carrier amplitude modulated with a 130 Hz sinusoidal wave
and switched to create 100 ms burst. For the respective frequency of the Qi-A13-Board (111 kHz) the
performance limits are 333 mV for CIEDs with unipolar leads and 33.3 mV for CIEDs with bipolar
leads. It is important to understand that the performance limits can only demonstrate that CIEDs
produce an appropriate level of EMC. However, for which exposure conditions the levels apply is not
stated due to the unknown correlation between performance limits and strength of external EMFs.
The objective of this study was to conduct a risk assessment of CIED patients by investigating
conditions in which the performance limits of CIEDs are fulfilled for magnetic fields at 111 kHz.
We therefore measured the induced voltage in a torso phantom in consideration of the most EMI
affecting parameters: type and position of the CIED lead as well as field distribution [19,20] in order to
test under real case (inhomogeneous) and worst-case (homogeneous) exposure conditions. For a risk
assessment we then compared the measured induced voltage with the performance limits.
2. Methods
The experimental setup consisted of either a set of Helmholtz coils or the Qi-A13-Board, a torso
phantom and a self-developed measuring system. With the self-developed measuring system induced
voltages were measured using standard endocardial pacing/sensing leads—one unipolar and one
bipolar lead. The measuring system was exposed to homogenous fields emitted by the Helmholtz coils
or inhomogeneous fields of the Qi-A13-Board in both operation modes (power transfer mode and
pinging mode) at four different positions within the torso phantom. All measurements were done in a
dedicated shielding chamber which attenuates external magnetic fields by 100 dB to 110 dB in the
frequency range from 100 kHz to 1000 kHz.
2.1. Torso Phantom and Measuring System
A schematic diagram of the torso phantom containing the measuring system is shown in Figure 1.
The human-shaped torso resembles a male upper body of size M and has a total volume of 30 L.
The torso was filled with deionized water and 0.14% sodium chloride to obtain a solution with an
electric conductivity of 0.25 S/m which simulates in average the electrical properties of a human body
(cf. 0.2 S/m [21] and 0.3 S/m [22]). In order to assure the measuring system’s position and thereby
define the implantation sites in the torso phantom, the implant-housing and the lead were attached to a
Int. J. Environ. Res. Public Health 2015, 12 5889
grid (27 × 30 cm). Two implant-housing positions (left- and right-pectoral) and two lead positions
(ventricle and atrium) were used to scrutinize the influence of the implantation site on the induced
voltage (Figure 1). All materials selected for the torso phantom and the grid are made of plastic and
can therefore be considered to have a relative permeability of 1 to ensure that they do not affect the
distribution of the magnetic field.
Figure 1. (a) Schematic diagram of the torso phantom. All implantation sites are indicated:
1. Housing: right-pectoral. Lead: atrium (RPA). 2. Housing: left-pectoral. Lead: atrium
(LPA). 3. Housing: right-pectoral. Lead: ventricle (RPV). 4. Housing: left-pectoral. Lead:
ventricle (LPV).The green area marks the unipolar induction area for the RPA implantation
site (ARPA). The orange area marks the unipolar induction area for the LPV implantation
site (ALPV). ARPV and ALPA are the unipolar induction areas of the implantation sites RPV
and LPA. (b) Sensing mechanism of a bipolar lead. A differential (the housing is the
reference electrode) voltage is measured between tip and ring electrode. (c) Sensing
mechanism of a unipolar lead. A voltage is measured between tip and the reference
(housing) electrode.
The induced voltage was measured by a self-developed circuit mounted in an implant-housing.
Therefore it is possible to connect the Setrox S53 bipolar lead (length: 53 cm, Biotronik, Berlin,
Germany) and the Capsure Sense 4073 unipolar lead (length: 58 cm, Medtronic, Minneapolis, MN,
USA). The circuit in the implant-housing consisted of a differential amplifier and an optical output to
transmit the induced voltage signal via an optical fiber (length 5 m) to a receiver circuit.
The differential amplifier worked linearly for input signals between ±150 mV at 111 kHz and
amplified the input signal by a factor of 10. The measured voltage signal is digitalized after the
receiver circuit with a 9223 analog input device (National Instruments™, Austin, TX, USA) with
differential input channels (±10V), 1 MHz sampling rate and 16 bit resolution. The described
Int. J. Environ. Res. Public Health 2015, 12 5890
measurement system was therefore capable of measuring the induced voltage in a bipolar as well as in
a unipolar lead.
2.2. Homogenous Field Exposure by Using Helmholtz Coils
The homogenous magnetic field was generated by a set of Helmholtz coils with a diameter of
0.71 m, which were driven by two 7224 amplifiers (1.1 kW max, DC-300 kHz, AE TECHRON®,
Elkhart, IN, USA). The produced magnetic field was homogeneous along the rotation axis
(±5% between the coils) and in the symmetry plane between the coils (±3% within ±18 cm from the
center). The coils were therefore capable of exposing the whole volume around the grid in the torso
phantom with a homogeneous magnetic field.
The magnetic flux density was controlled by measuring the current in a series shunt (12 ).
Each of the coils had two windings and an inductance of 6 µH. A magnetic flux density of 5.1 μT/A
was generated. The maximum magnetic flux density for sine bursts at 111 kHz was 30 µT.
The maximum exposure was set to 27 µT which is the ICNIRP reference level from 2010 for
general public exposure to time varying magnetic fields at 111 kHz [14]. The reference level of the
respective ICNIRP guideline from 1998 for general public exposure is 6.25 µT [13]. ICNIRP 2010
only replaces the ICNIRP 1998 exposure limits in the frequency range of 1 Hz to 100 kHz. However
values are provided up to 10 MHz for some guidance. In order to comply with both guidelines the
torso phantom was exposed homogenously to magnetic fields (111 kHz sine-bursts of 100 ms
duration) from 5 µT to 27 µT (in 1 µT steps).
For two measurements with the unipolar lead the magnetic flux density range was changed because
the induced voltage exceeded the linear input range (±150 mV) of the differential amplifier of the
measurement system. For the left-pectoral ventricle position (LPV) the magnetic flux density range
was set from 1 µT to 8 µT and for the left-pectoral atrium position (LPA) it was set from 1 µT to 9 µT.
2.3. Inhomogeneous Field Exposure by Using the Qi-A13-Board
The measurements of the voltage induced by the Qi-A13-Board were done in two operating modes
(power transfer and pinging mode). In the power transfer mode an AVID-Receiver Qi Receiver
Simulator from AVID Technologies (Burlington, MA, USA) was placed on the Qi-A13-Board.
The AVID-Receiver ensures continuous power transfer with the maximum deliverable power of 5 W by
connecting external load of 5 Ohm. The position of the AVID-Receiver on the Qi-A13-Board and the
position in relation to the torso phantom of both devices together, were then systematically changed to find
the position where the induced voltage has the highest amplitude (worst-case position). This was done for
all four implantation sites and each time the induced worst-case voltage was recorded.
The procedure of identifying the worst-case position was repeated with the Qi-A13-Board in the
pinging mode—that means neither the AVID-Receiver nor any other receiver was used. The pinging
mode was activated by touching the Qi-A13-Board briefly with one hand. Again for LPV-, LPA-,
RPV- and RPA-position, the induced worst-case voltages were measured. In this mode a second
measurement of the induced voltages was done at 10 cm distance to the previously identified
worst-case position. A 10 cm distance was considered to assess the attenuation of the induced voltage.
The distance was created along a line that was perpendicular to the surface of the torso phantom.
Int. J. Environ. Res. Public Health 2015, 12 5891
To determine the field distribution of the Qi-A13-Board in both operating modes, magnetic flux
density measurements were performed with a calibrated Exposure Level Tester 400 (ELT-400) from
Narda Safety Test Solutions® (Pfullingen, Germany). Unless specified differently,
the measurements were averaged over one second and taken in the Root-Mean-Squared (RMS) mode.
The field strength mode was set to 320 µT (range low) and the selected frequency range was set from
30 Hz to 400 kHz. The measurement uncertainty in the range from 50 Hz to 120 kHz is declared not to
be higher than ±6% according to the ELT-400 manual.
As a standard approach [23], we first conducted field measurements with a 100 cm2 isotropic
magnetic field probe. For the measurements, the position of the probe was slewed systematically over
the Qi-A13-Board to find the spot where the magnetic flux density reaches the highest amplitude in
both operation modes. In the power transfer mode the AVID-Receiver also was moved on the board in
order to find the worst-case magnetic flux density.
The 100 cm2 probe’s diameter of around 12 cm allowed only a rough determination of the field
distribution of the Qi-A13-Board. Therefore we conducted a second measurement using an isotropic
magnetic field probe with a small effective area of 3 cm² and an outer diameter of 3 cm. This allowed
measurements of highly inhomogeneous magnetic fields and even small recesses of the Qi-A13-Board
to be assessed.
The field measurements were conducted systematically on a grid with the dimension of
350 × 300 mm in two planes parallel to the coil array of the Qi-A13-Board at distances of 2 cm and 10
cm. The measuring points in those planes were located on the grid with a spacing of 3 cm to 4 cm.
Some points had to be slightly shifted or excluded due to protrusions of the Qi-A13-Board or the
AVID-Receiver (in case of power transfer mode). The measuring points refer to the tip of the probe
and a distance correction to the center of the probe is taken into account.
In power transfer mode the AVID-Receiver on the Qi-A13-Board was positioned so that the
magnetic flux density reached the highest amplitude but the power transfer was still stable during the
entire measurement. In pinging mode the ELT-400 was set to MAX HOLD to ensure measurement of
the maximum magnetic field. All field measurements were assessed in time and frequency domain.
2.4. Signal Analysis
The signal analysis was performed using MATLAB® Release 2014b from The MathWorks,
Inc. (Natick, MA, USA). For the estimation of the amplitude of the induced voltage (sine-burst signals)
the least squares method was applied for every = 10 consecutive samples using Equation (1) as
curve fitting function:
=
, sin()+, cos() (1)
The 10 samples of the measured data () include the information of one period of the 111 kHz
sine wave (sample rate 1 MHz). With this method =10,000 amplitude estimations were conducted
during one sine-burst with the duration of 100 ms. The amplitude () was calculated with the
estimated parameters using Equation (2):
=
,+, (2)
Int. J. Environ. Res. Public Health 2015, 12 5892
The arithmetic mean of the estimated amplitudes was then determined using Equation (3) to obtain
the induced voltage i:
i=1


(3)
Additionally, the coefficient of determination was calculated using Equations (4) and (5) to examine
the quality of each sine-fit:
=1(−
,)

(−
)
 (4)
=min(
) (5)
As a second quality criterion the relative standard deviation (STD) of the estimated amplitudes
were calculated. In order to estimate the induced voltage for the not tested magnetic flux densities the
results of i were fitted with the linear function in Equation (6):
i,extrapolation =
+ (6)
3. Results
3.1. Homogenous Field Exposure by Using Helmholtz Coils
The results of the induced voltage for the four implantation sites and the two lead types are shown
in Figure 2 together with the performance limits of ISO 14117. The results of the linear fit of the
measured voltage are given in Table 1 and shown in Figure 2. The induced voltage and the
performance limit are always expressed as peak values, however, the magnetic flux density as root
mean square.
As shown in Table 1 and Figure 2 the induced voltage was strongly dependent on the implantation
site and the lead type (bipolar/unipolar). On the left-pectoral implantation sites the voltages induced in
unipolar leads were 5.8 to 7.6 times higher in comparison to the bipolar leads (cf. a
1 Table 1).
However, the performance limit for bipolar leads is 10 times lower than for the unipolar leads [18].
Thus, the performance limit is exceeded at lower magnetic flux densities (cf. Figure 2). The lowest
magnetic flux density at which the bipolar performance limit (33.3 mV) was exceeded is 11.0 µT.
The lowest magnetic flux density at which the unipolar performance limit (333 mV) was exceeded is
19.4 µT considering linear correlation between the flux density and the induced voltage (cf. Figure 2
dashed lines). In both cases the first exceedance occurred at the left-pectoral ventricle position
(red curve in Figure 2).
Int. J. Environ. Res. Public Health 2015, 12 5893
Figure 2. Results of the induced voltage for the homogenous exposure for (a) the bipolar
lead, and (b) the unipolar lead. The linear fit to the measured values is indicated by the
solid lines. The dashed lines indicate the extrapolation of the linear fit to the ranges where
no induced voltages were measured due to the operation range of the used differential
amplifier of the measurement system.
Table 1. Results for the linear fit of the induced voltage.
Lead
Unipolar/Bipolar
Housing
Position
Lead
Position (V/mV)
Equation (6) (mV)
Equation (6) of the
Linear Fit
Bipolar
Left-pectoral Ventricle 2.93 0.96 0.9999
Atrium 2.04 0.95 0.9998
Right-pectoral Ventricle 1.27 0.60 0.9998
Atrium 0.36 0.15 0.9998
Unipolar
Left-pectoral Ventricle 17.09 1.68 0.9999
Atrium 15.55 1.68 0.9999
Right-pectoral Ventricle 2.26 1.09 0.9997
Atrium 0.48 0.20 0.9998
On the right-pectoral implantation sites, clearly less voltage was induced than on the left pectoral
implantation sites—2.3 to 5.7 times lower for the bipolar lead and 7.6 to 32.4 times lower for the
unipolar lead (cf. Table 1). The voltage induced in the unipolar lead was higher than in the bipolar
lead like it was on the left-pectoral implantation sites. Only the right-pectoral ventricle position
exceeded the performance limit at 25.6 µT (cf. green curve Figure 2a). The other three implantation
sites (RPA unipolar and bipolar, RPV unipolar) kept clearly below the limits of ISO 14117 even at
Int. J. Environ. Res. Public Health 2015, 12 5894
maximum exposure. The quality criterion states a very good compliance of the measured voltage
with the linear functions (cf. Figure 2 compliance of black dots with colored lines).
3.2. Inhomogeneous Field Distribution by Using Qi-A13-Board
Figure 3 shows a typical pinging sequence recorded during pinging mode of the Qi-A13-Board.
The pinging sequence had a length of 3200 ms and consisted of two or three consecutive sine-bursts
with a frequency of 111 kHz. The bursts had a width of 66 ms and a 32 ms pause in between.
The pause between the consecutive bursts varied from 430 ms to 840 ms during our recordings.
The burst amplitudes varied depending on which of the three coils on the Qi-A13-Board was driven.
For the evaluation of the induced voltage (cf. Section 3.3) always the burst with the highest amplitude
was chosen.
As described before, the pinging mode can be activated by objects placed on the top of the
capacitance-based touch electrode and terminates if no answer is received. During the measurements
we noticed, that the pinging mode stayed activated as long as the capacitance-based electrode was
touched. In this case the pinging sequence (cf. Figure 3) was repeated by the Qi-A13-Board.
Figure 3. Pinging sequence recorded during pinging mode of the Qi-A13-Board.
The amplitude is normalized to one.
In Figure 4 the inhomogeneous field distribution of the Qi-A13-Board is depicted for the power
transfer (a, b) and pinging mode (c, d). It was determined using the 3 cm2 magnetic field probe.
The highest magnetic flux density (127 µT) occurred during the pinging mode at a distance of 2 cm
over the center of the Qi-A13-Board (Figure 4c). At a 10 cm distance the magnetic flux density drops
about 98% to 2.4 µT at maximum (Figure 4d). The maximum value measured in the power transfer
mode is 53 µT at 2 cm distance and alongside the AVID-Receiver (Figure 4a). At a 10 cm distance the
magnetic flux density drops about 96% to 2.2 µT (Figure 4b).
The maximum magnetic flux density measured with the 100 cm² probe was 12.5 µT in the pinging
mode and 4.7 µT in the power transfer mode. The background noise level was quantified in the
Int. J. Environ. Res. Public Health 2015, 12 5895
measured spectrum (30 Hz to 400 kHz) to a maximum value of 0.65 µT for all measurements on the
Qi-A13-Board.
Figure 4. The measured magnetic flux density vs. the coordinates x and y on the plane is
shown for the power transfer mode at two distances (2 cm (a) and 10 cm (b)) and for the
pinging mode at two distances (2 cm (c) and 10 cm (d)). The missing values in the plot of
the power transfer mode at 2 cm (a) are caused by the housing of the AVID-Receiver.
3.3. Inhomogeneous Field Exposure by Using the Qi-A13-Board in Power Transfer Mode
In the power transfer mode 10.8% of the performance limit was reached at maximum (cf. Table 2
LPA unipolar lead). Using a bipolar lead 7.5% of the performance limit was reached at maximum
(RPA). The induced voltage in both implant-housing positions and with both lead types was higher at
the atrium position than at the ventricle positions—20% to 67% for the bipolar lead and 60% to 88%
for the unipolar lead. In Table 2 the induced worst-case voltages that occurred during the exposure
with the Qi-A13-Board in power transfer mode are given. The highest voltages were induced when the
AVID-Receiver and the Qi-A13-Board together were in the worst-case position. The AVID-Receiver
was then close to the edge of the Qi-A13-Board (cf. Figure 5b). The worst-case position of the
AVID-Receiver and the Qi-A13-Board on the torso phantom changed whenever the implantation site
or the lead type was changed. In general it can be stated, that the worst-case position was on the lateral
wall of the phantom at a height slightly above the tip of the lead (cf. Figure 5a).
Int. J. Environ. Res. Public Health 2015, 12 5896
Table 2. The worst-case voltage induced by the exposure with the Qi-A13-Board in power
transfer mode.
Lead
Type
Housing
Position
Lead
Position
i
(mV)
Percentage of
the Performance
Limit (%)
Relative
STD (%) Equation (5)
Bipolar
Left-pectoral Ventricle 2.0 6.0 2.3 0.9994
Atrium 2.4 7.2 1.3 0.9997
Right-pectoral Ventricle 1.5 4.5 1.3 0.9992
Atrium 2.5 7.5 1.4 0.9997
Unipolar
Left-pectoral Ventricle 19.1 5.7 0.1 >0.9999
Atrium 35.9 10.8 0.1 >0.9999
Right-pectoral Ventricle 11.1 3.3 0.1 0.9999
Atrium 17.8 5.3 0.3 0.9998
Figure 5. (a) Torso phantom and Qi-A13-Board (pinging mode) on the lateral wall;
(b) AVID-Receiver close to the edge of the Qi-A13-Board. If the AVID-Receiver was
moved further over the edge the connection was interrupted.
3.4. Inhomogeneous Field Exposure by Using the Qi-A13-Board in Pinging Mode
In the pinging mode 45.7% of the performance limit was reached at maximum (cf. Table 3 LPA
unipolar lead). Using a bipolar lead 37.6% of the performance limit was reached at maximum (RPA).
By increasing the distance between the Qi-A13-Board and the worst-case position on the torso
phantom from 0 cm to 10 cm the induced voltage was reduced by 93% on average. This complies with
the results of magnetic field measurements where the magnetic flux density drops about 98% at a
distance of 10 cm (cf. Section 3.2.). Furthermore, at the left-pectoral implantation sites a higher voltage
was induced than at the right-pectoral implantation sites for unipolar leads. Likewise for bipolar leads
at the left-pectoral ventricle position a higher voltage was induced than at the right-pectoral ventricle
position. Though, the induced voltage at the left-pectoral atrium position was lower than at the
right-pectoral atrium position. In Table 3 the results of the induced voltage when exposed with the
Qi-A13-Board in pinging mode at a distance to the phantom of 0 cm (worst-case) and 10 cm are given.
Int. J. Environ. Res. Public Health 2015, 12 5897
Table 3. Induced voltage at 0 cm distance (worst-case) and at 10 cm distance by the
Qi-A13-Board in pinging mode.
Lead
Type/Setup
Housing
Position
Lead
Position i (mV)
Percentage of the
Performance Limit
(%)
Relative
STD (%) Equation (5)
Bipolar/0
cm distance
Left-pectoral Ventricle 6.72 20.4 0.2 0.9999
Atrium 6.84 20.7 2.8 0.9999
Right-pectoral Ventricle 6.37 19.3 0.2 0.9999
Atrium 12.40 37.6 0.1 0.9999
Bipolar/10
cm distance
Left-pectoral Ventricle 0.72 2.2 2.0 0.9970
Atrium 0.64 1.9 2.2 0.9952
Right-pectoral Ventricle 0.41 1.2 3.5 0.9873
Atrium 0.52 1.6 2.7 0.9925
Unipolar/0
cm distance
Left-pectoral Ventricle 54.12 16.4 0.1 >0.9999
Atrium 150.72 45.7 0.1 >0.9999
Right-pectoral Ventricle 42.94 13.0 0.2 >0.9999
Atrium 85.38 25.9 0.1 >0.9999
Unipolar/10
cm distance
Left-pectoral Ventricle 5.31 1.6 0.3 0.9999
Atrium 6.56 2.0 0.3 0.9999
Right-pectoral Ventricle 2.49 0.8 0.6 0.9996
Atrium 3.37 1.0 0.5 0.9998
The worst-case positions for this operating mode were similar to the worst-case positions found for
the power transfer mode. Hence, the worst-case positions still belongs to the lateral wall of the
phantom model (cf. Figure 5).
The quality of the amplitude estimations for all shown measurements is very high (cf. Table 2
and Table 3). The lowest (0.9873) occurred at very low input voltage (cf. Table 3). Still this
estimation explains 98.7% of the variation of the measured signal. For the results with higher induced
voltages the value increases even more (>0.9999) due to the improving signal to noise ratio.
The second quality criterion, the relative standard deviation, confirms the values of the amplitudes as
well. The variation of the estimation was not higher than 3.5% and occurred in the same measurement
as the lowest . With increasing signal to noise ratio the relative STD reaches even values of 0.1%
(cf. Table 2 and Table 3). The amplitude estimation function (Equation (1)) is therefore a precise
measure for the induced voltage amplitude.
4. Discussion and Conclusions
4.1. Risk Assessment of CIEDs When Exposed to Magnetic Fields at 111 kHz
At homogenous exposure to 111 kHz magnetic fields the induced voltage exceeded the performance
limits defined in ISO 14117 and therefore EMI with CIED is conceivable. The lowest magnetic
flux density at which the performance limit was exceeded was 11 µT (cf. Section 3.1). This is about
77% above 6.25 µT which is the respective ICNIRP reference level for general public exposure at
111 kHz [13]. The situation needs to be reassessed as ICNIRP will soon announce the new guideline
Int. J. Environ. Res. Public Health 2015, 12 5898
on limiting exposure to EMF in the range of 100 kHz to 300 GHz [24]. The exceedance of ISO 14117,
however, cannot be equated with a hazard for patients with CIEDs. The hazard limit depends not only
on the induced voltage and the frequency but also on the shape of the induced signal as well as
construction features (e.g. filter design) of the CIED [25]. Therefore the hazard limit is individually
different and might be higher than the performance limit.
According to Figure 2 the exceedance of the performance limits occurred at LPV-, LPA- and
RPA-position for the bipolar lead and LPV- and LPA-position for the unipolar lead. However,
this result should be understood in the context of the test conditions of ISO 14117. Devices
programmed to unipolar sensing mode ought to be tested in 2.0 mV sensitivity setting and devices in
bipolar sensing mode ought to be tested in 0.3 mV sensitivity setting. This means, if for the unipolar
lead the same sensitivity setting and thus the same performance limit than for the bipolar lead had been
considered, the induced voltage would be exceeded already at 1.83 µT (LPV-position in Figure 2b).
These findings that EMI with CIEDs occurs at lower field levels when using unipolar instead of
bipolar leads complies with in vivo investigations by Tiikkaja et al. [26]. They exposed 24 CIED
patients with magnetic fields of different patterns (sine, pulse, ramp, and square waveform) with flux
densities up to 0.3 mT. Only CIEDs tested in unipolar sensing mode were affected by the magnetic
fields. Bipolar settings caused no interference.
The first exceedance of the performance limit under homogeneous field exposure at 11 µT is lower
than the highest magnetic flux density measured at the Qi-A13-Board (127 µT with the 3 cm2 probe
and 12.5 µT with the 100 cm2 probe, cf. Section 3.2). However, with the Qi-A13-Board not more than
45.7% of the performance limit could be reached. Thus, an EMI risk assessment of CIEDs exposed by
the Qi-A13-Board cannot be performed on the basis of the results of the homogeneous exposure,
because the risk would be overestimated.
For the inhomogeneous fields emitted by wireless power transfer base stations, e.g., Qi-A13-Boards
so far no recommendations considering CIED patients have been published—in fact research needs
have been addressed by Christ et al. [17]. In Figure 6 the induced voltages from the exposure with the
Qi-A13-Board are summed up for all four implantations sites (LPV, LPA, RPV and RPA),
for the unipolar and bipolar lead type as well as for power transfer and pinging mode. The results are
shown in relation to the performance limit of ISO 14117 as the percentage portion of these limits.
In neither of the scrutinized cases, the induced voltage exceeded the performance limits of ISO 14117.
However, 45.7% of the performance limit was reached using the unipolar lead and 37.6% were
reached using the bipolar lead at maximum (cf. Figure 6). The maxima of the induced voltage occurred
when the Qi-A13-Board operated in the pinging mode which is in accordance with the field
measurements where the highest magnetic flux density (127 µT) was also found in the pinging mode
(cf. Section 3.2). At a distance of 10 cm between the Qi-A13-board and the torso phantom only a
maximum of 2.2% of the performance limit was reached.
Int. J. Environ. Res. Public Health 2015, 12 5899
Figure 6. The percentage portion of the performance limits of ISO 14117 contextualized
with the most EMI affecting parameters: the four implantations sites, the two lead types
and the two operating modes of the Qi-A13-Board. Additionally the attenuation of the
induced voltage at 10 cm distance is presented (compare red and blue markers).
Regarding the influence of the implantation site at inhomogeneous field exposure: the left-pectoral
position as well as at the atrium position generally a higher voltage was induced than at the
right-pectoral position and the ventricle position (cf. Section 3.3 and 3.4). At the atrium position the
induced voltage is about a factor of approx. 2 closer to the performance limit than it is at the ventricle
position (cf. Figure 6). Thus, for inhomogeneous field exposure EMI with CIEDs is more likely to
occur in the atrial lead.
Our results revealed that inhomogeneous exposure with Qi-A13-Boards does not exceed 46% of the
performance limit even under worst-case conditions in a torso phantom. However, in consideration of
general limitations of phantom models—torso shape, lead position and time variant tissue conductivity
might be different in humans—a safety margin is recommended for transferring the results to humans
with CIEDs. In our torso phantom a 10 cm distance of the Qi-A13-Board assured a safety margin
where the induced voltage is nearly 50 times smaller than the performance limit.
Our method of measuring the induced voltage and comparison with the performance limits of
ISO 14117 is a way of risk assessment which enables a general statement about potential EMI with
CIEDs because all manufacturers are well-advised to test their devices according to the product
standard to benefit from the presumption of conformity given by harmonized standards. In most other
studies only a limited number of CIEDs were investigated which often limits their outcomes to the
tested devices [7,27–29].
Int. J. Environ. Res. Public Health 2015, 12 5900
4.2. Correlation between Induced Voltage and Strength of EMF
Correlation of CIED’s interference input voltage with external EMF is a very complex matter.
The induced voltages depend on so-called coupling factors that vary between extremely low and radio
frequency fields. It also depends on the field distribution as our results of homogeneous and
inhomogeneous field exposure confirm. The inhomogeneous field distribution is defined by the design,
the geometry and the materials used of the field source which is in case of the Qi-A13-Board one of
the three coils. To determine the induced voltage in previous studies phantom models [6,7,22,27,29–33],
theoretical considerations [20,31,32,34] or numerical simulations [35,36] are used with different
approaches for specific exposure conditions.
For unipolar leads exposed to homogeneous fields correlations between the external magnetic fields
and induced voltage in the intermediate frequency range can be found in [20,30–34]. The correlations
introduced are all based on Faraday’s law of induction (Equation (7)):
 ~(7)
The stands for the effective unipolar induction area (cf. Figure 1) and  is the induced
voltage in a unipolar lead. The applicability of the induction law was stated to frequencies up to
50 kHz [30–34]. Only Irnich [20] indicated the applicability up to 1 MHz. However, this statement is
only based on analytical results and no measurements are provided. In our study the dependency of the
unipolar induction area is clearly shown (cf. Figure 2b).
For bipolar leads correlations were developed by Hille et al. [31,32], Irnich [20] and Mattei et al. [33].
Hille et al. [31,32] measured the voltage induced in a bipolar lead with a phantom model and
Helmholtz coils for homogenous exposure. They found an interception point of the induced unipolar
and bipolar voltage at around 9 kHz (investigated frequency range: 50 Hz to approx. 20 kHz).
For frequencies higher than 9 kHz the voltage induced in the scrutinized bipolar lead was higher than
in the unipolar lead. However, the presented measurement system had no optical fiber in order to
prevent noise coupling into the connection cable. In addition the phantom used was not human shaped
and the scrutinized bipolar lead had a distance of 15 mm between tip and ring electrode. In our study
we used a bipolar lead with 10 mm distance between tip and ring electrode. According to Irnich [20]
the tip-ring-distance has major influence on the induced voltage.
Irnich [20] derived a correlation analytically by comparing the coupling mechanism of unipolar and
bipolar leads in magnetic fields. For a given magnetic flux density, he stated, that the voltage induced
in a bipolar lead () is reduced by a factor of 
( is the length of the lead and is the tip-to-ring
distance, cf. Equation (8)) compared to the voltage induced in a unipolar lead ():
=uni
bi for
≤1(8)
Equation (8) relates to the left-pectoral ventricle implantation site, however, it does not take into
account the effects of different implantation sites. Applied to our study this equation would mean a
factor of approximately 50 between the voltage induced in unipolar and bipolar lead. In fact,
for the different implantation sites investigated we derived factors between 1.3 and 7.6 as depicted in
Table 4 (homogeneous exposure).
Int. J. Environ. Res. Public Health 2015, 12 5901
Table 4. Comparison of the factor ( 
) of the voltage induced in unipolar and
bipolar leads at the four implantation sites.
Setup LPV LPA RPV RPA
Homogeneous exposure 5.8 7.6 1.8 1.3
Qi-A13-Board power transfer 9.6 15.0 7.4 7.1
Qi-A13-Board pinging (0 cm) 8.1 22.0 6.7 6.9
Mattei et al. [33] measured the voltage induced in unipolar and bipolar leads with a phantom model
and coils of two different diameters (30 cm and 10 cm) for the exposure. They scrutinized magnetic
fields with a frequency of 125 kHz and different implantation sites. The study design closely resembles
the experimental setup of our study. Mattei et al. concluded that the voltage induced in a bipolar lead is
reduced by a factor of 3–6, which lies within our findings (cf. Table 4). Additionally, Mattei et al. [33]
presented that the voltage in a bipolar lead induced by using a 10 cm-coil reaches a maximum if it is
positioned in a more curved path which complies with our findings that the induced voltage is higher at
the atrium position for inhomogeneous fields.
Acknowledgments
This research project was third-party funded with an unrestricted grant and supported by the
Research Association of Automotive Technology (FAT) and its Working Group 1 “Car and
Environment” which is part of the German Association of the Automotive Industry (VDA). We thank
Freescale Halbleiter Deutschland GmbH for providing the Qi-A13-Board and the following colleagues
for their support and input: Sarah Driessen, Frank Gollnick, Ralph Kühn and Günter Wermeester.
Author Contributions
Tobias Seckler and Dominik Stunder conceived and designed the experiments. Tobias Seckler,
Kai Jagielski and Dominik Stunder performed the experiments. Tobias Seckler and Dominik Stunder
analyzed the data. Tobias Seckler wrote the manuscript. Dominik Stunder and Kai Jagielski made
worthwhile revisions.
Conflicts of Interest
The authors declare no conflict of interest. The founding sponsors had no role in the design of the
study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the
decision to publish the results.
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© 2015 by the authors; licensee MDPI, Basel, Switzerland. This article is an open access article
distributed under the terms and conditions of the Creative Commons Attribution license
(http://creativecommons.org/licenses/by/4.0/).
... Gustrau et al. 61 identified induced voltages at the PM terminals of 0.126 mV-131 mV (1 kHz-1 MHz, at 1 A/m, i.e. 1.26 mT). Gustrau et al., 61 Seckler et al., 58 and Mattei et al. 59 found a dependence of the induced voltage on lead configuration. ...
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Patients with cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy devices (CRT) are exposed to different types of electromagnetic interference (EMI) at home and at work. Due to the constantly increasing role of electrically active appliances in daily use and the introduction of new therapy concepts such as the leadless cardiac pacemaker and the subcutaneous defibrillator, this topic is of great relevance. The further development of the implanted devices and the almost complete use of bipolar leads has reduced the overall risk of EMI. This review article provides information about the current status of possible interference in the private environment and how to avoid it. In addition, information is provided on how to deal with occupational sources of interference.
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In der vorliegenden Stellungnahme der Deutschen Gesellschaft für Kardiologie (DGK) in Zusammenarbeit mit der Deutschen Gesellschaft für Arbeits- und Umweltmedizin (DGAUM) werden elektromagnetische Interferenzen bei elektrisch aktiven kardialen Implantaten diskutiert, die vorhandene Literatur zusammengefasst und, soweit möglich, bewertet. Aufgrund der zunehmenden Technisierung des Alltags und des beruflichen Umfelds mit immer mehr elektrischen oder elektronischen Geräten erlangt das Thema zunehmende Relevanz. Dies wird begleitet von Weiterentwicklungen der bestehenden transvenösen Implantate sowie neuen Aggregattechnologien wie kabellosen Schrittmachern und total subkutanen implantierbaren Kardioverter-Defibrillatoren. Die Konfiguration von elektromagnetischen Feldern (EMF) kann bezogen auf Frequenz und Feldstärke stark variieren und ruft im Körper und somit am Aggregat ganz unterschiedliche Reaktionen hervor. Der physikalische Hintergrund der Wirkung von EMF auf Körper und Implantat wird allgemein verständlich dargestellt. Verschiedene Störszenarien werden auch in Bezug auf die Grunderkrankung erläutert. Aus interdisziplinärer Perspektive werden Aspekte einer Exposition mit EMF sowohl im Alltag als auch im beruflichen Umfeld beleuchtet. Der primären Implantatversorgung EMF-exponierter Patienten, der Risikobewertung im arbeitsmedizinischen Kontext und der Geräteprogrammierung mit Troubleshooting kommt hierbei besondere Bedeutung zu. Zudem werden konkrete Vorgehensweisen für Arbeitsmediziner in Betrieben an die Hand gegeben, um den Wiedereingliederungsprozess zu unterstützen. Im Rahmen dessen erfolgt auch eine kurze Darstellung der aktuellen Gesetzeslage. Überdies soll das Dokument motivieren, Studien aufzulegen, die das Thema der elektromagnetischen Interferenz in vivo für aktuelle Aggregatgenerationen sowie Neuentwicklungen systematisch untersuchen, sodass eine suffiziente Risikobewertung für verschiedene Frequenzbereiche und damit technische Geräte erfolgen kann.
Article
This paper deals with the assessment of the induced voltage in an unipolar pacing lead produced by the coil currents of a wireless power transfer (WPT) system for battery recharging of an electric vehicle (EV). In the first part of the work, the magnetic field distributions inside and outside an EV equipped with the WPT technology is carried out by finite element (FE) simulations using the artificial material single layer (AMSL) method. The FE-AMSL method efficiently predicts field reflection and the transmission of the EV conductive bodyshell, while avoiding the fine mesh discretization of the conductive regions and taking into account the skin effect. In the second part, the calculated magnetic field is used as an electromagnetic source of a unipolar pacing lead implanted in the human body. Some original calculation methods are proposed to assess the induced voltage in the loop area formed by a lead. By the proposed procedure, it is possible to quickly calculate the electromagnetic interference in the pacemaker during wireless battery recharging of an EV. The induced voltage is one of the most important parameters to perform the risk analysis and assessment.
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As the number of patients having implantable cardioverter defibrillator (ICD) devices is increasing, it is important for the physicians and patients to be aware of situations and conditions that can result in interference with normal functioning of these devices. There are multiple cases of malfunction of ICDs reported in literature and it may be of great significance to have an overview of these incidents for appropriate recognition and future prevention. Here we are reviewing the available literature as well as reporting an interesting case of electromagnetic interference (EMI) resulting from leak of current in pool water causing firing of ICD.
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Introduction: The electromagnetic interference (EMI) of active implantable medical devices (AIMDs) due to 125–135 kHz and HF (13.56MHz) radio-frequency identification (RFID) reader/writers are discussed based on in vitro experiments. The purpose of this paper is to clarify the detailed EMI occurrence conditions of both implantable cardiac pacemakers and implantable cardioverter defibrillators (ICDs) when used in proximity to commercial lowband RFID reader/writers. Methods and results: A total of 20 types of pacemakers and 7 types of ICDs from 9 manufacturers are used in the experiments. The tested RFID reader/writers are 4 types of 125–135 kHz antennas and 26 types of HF antennas. The test system is newly constructed based on the one previously proposed for the estimation of EMI due to mobile phones. The measured reactions are missing of pacing pulses and generation of asynchronous pulses for pacemaker functions and inappropriate tachyarrhythmia detection and delivery of therapy for ICDs. In addition, measured EMI characteristics strongly depend on intermittent period of RFID signals. However, all AIMDs tested return to normal operation once removed from RFID exposure. Conclusion: The detailed EMI characteristics of AIMDs and low-band RFID reader/ writers are obtained to prevent adverse interactions.
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AimsElectromagnetic interference (EMI) can pose a danger to workers with pacemakers and implantable cardioverter-defibrillators (ICDs). At some workplaces electromagnetic fields are high enough to potentially inflict EMI. The purpose of this in vivo study was to evaluate the susceptibility of pacemakers and ICDs to external electromagnetic fields.Methods and resultsEleven volunteers with a pacemaker and 13 with an ICD were exposed to sine, pulse, ramp, and square waveform magnetic fields with frequencies of 2-200 Hz using Helmholtz coil. The magnetic field flux densities varied to 300 μT. We also tested the occurrence of EMI from an electronic article surveillance (EAS) gate, an induction cooktop, and a metal inert gas (MIG) welding machine. All pacemakers were tested with bipolar settings and three of them also with unipolar sensing configurations. None of the bipolar pacemakers or ICDs tested experienced interference in any of the exposure situations. The three pacemakers with unipolar settings were affected by the highest fields of the Helmholtz coil, and one of them also by the EAS gate and the welding cable. The induction cooktop did not interfere with any of the unipolarly programmed pacemakers.Conclusion Magnetic fields with intensities as high as those used in this study are rare even in industrial working environments. In most cases, employees can return to work after implantation of a bipolar pacemaker or an ICD, after an appropriate risk assessment. Pacemakers programmed to unipolar configurations can cause danger to their users in environments with high electromagnetic fields, and should be avoided, if possible.
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The European Heart Rhythm Association (EHRA), a branch of the European Society of Cardiology (ESC), in observance to its mission - To improve the quality of life of the European population by reducing the impact of cardiac arrhythmias and reduce sudden cardiac death – is proudly announcing the launch of a Supplement to EP Europace Journal dedicated to the EHRA White Book entitled: Statistics on the Use of Cardiac Electronic Devices and Electrophysiological Procedures in the ESC 54 countries: 2012 Report from the European Heart Rhythm Association . The report represents a structured analysis of data collected in the EHRA White Book, an important monograph published by EHRA since 2008. The current report brings together the most up-to-date statistics on electrophysiological procedures including the implantation of cardiovascular electronic devices in the 54 ESC countries and includes all data of the first five Editions of the EHRA White Book. The report has been arranged to present the full information about the historical perspective of the EHRA White Book, the methodological aspects of the data collection and analysis of major treatments of heart rhythm disorders: Implantable Pulse Generators (IPGs), Implantable Cardioverter Defibrilators (ICDs), Cardiac Resynchronization Therapy (CRTs) and Catheter Ablation Procedures. Moreover, the increasing relevance of societal and economic implications of life-saving therapies led EHRA to give particular emphasis to them in a section of the current report. The figures and tables of this report speak by themselves and clearly highlight significant inequalities in healthcare In Europe, with an additional very large treatment gradient from West to East. These inequalities in healthcare are not specific of one treatment but equally apply to all therapies considered in the EHRA White Book. Barrier to access to different therapies are not only represented by the heterogeneous reimbursement system in ESC countries or by other country-specific …
Conference Paper
The static magnetic field generated by MRI systems is highly non-homogenous and rapidly decreases when moving away from the bore of the scanner. Consequently, the movement around the MRI scanner is equivalent to an exposure to a time-varying magnetic field at very low frequency (few Hz). If people with an implanted pacemaker (PM) enter the MRI room, fast movements may thus induce voltages on the loop formed by the PM lead, with the potential to modify the correct behavior of the stimulator. In this study, we performed in-vitro measurements on a human-shaped phantom, equipped with an implantable PM and with a current sensor, able to monitor the activity of the PM while moving the phantom in the MRI room. Fast rotational movements in close proximity of the bore of the scanner caused the inappropriate inhibition of the PM, programmed in VVI modality, maximum sensitivity, unipolar sensing and pacing. The inhibition occurred for a variation of the magnetic field of about 3 T/s. These findings demonstrate that great care must be paid when extending PM MRI compatibility from patients to healthcare personnel, since the safety procedures and the MRI-conditional PM programming (e.g. asynchronous stimulation or bipolar sensing) used for patients cannot be applied.
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The strong reactive near-field wireless power transmission (WPT) systems induce electric fields in the body tissue of persons in their close vicinity. This may pose potential direct health hazards or indirect risks via interference with medical implants. In this paper, the safety guidelines and the fundamental coupling mechanisms of the human body with the electromagnetic near fields of WPT are reviewed as well as the methodology and the instrumentation for the demonstration of the safety of such systems operating between 100 kHz and 50 MHz. Based on this review, the advantages and shortcomings of state-of-the-art numerical and experimental techniques are discussed and applied to a generic WPT operating at 8 MHz. Finally, current research needs are identified which include: 1) the extension of safety guidelines for coverage of persons with implants; 2) more computationally efficient full-wave solvers; 3) higher quality human models which cover different population groups and include improved models of nerve tissue; 4) experimental dosimetric methods for the WPT frequency range; and 5) product standards to demonstrate safety of specific WPT.
Article
The aim of this study is to propose setups for in vitro assessment of RFID (radiofrequency identification) interference on pacemakers (PM). The voltage induced at the input stage of the PM by low-frequency (LF) and high-frequency (HF) RFID transmitters has been used to quantify the amount of the interference. A commercial PM was modified in order to measure the voltage at its input stage when exposed to a sinusoidal signal at 125 kHz and 13.56 MHz. At both frequencies, two antennas with different dimensions (diameter = 10 cm and 30 cm, respectively) were used to generate the interfering field, and the induced voltage was measured between the lead tip and the PM case (unipolar voltage), and between the tip and ring electrodes (bipolar voltage). The typical lead configurations adopted in similar studies or proposed by international standards, as well as lead paths closer to actual physiological implants were tested. At 125 kHz, the worst-case condition differs for the two antennas: the 10 cm antenna induced the highest voltage in the two-loop spiral configuration, whereas the 30 cm antenna in the 225 cm(2) loop configuration. At 13.56 MHz, the highest voltage was observed for both the antennas in the 225 cm(2) loop configuration. Bipolar voltages were found to be lower than the unipolar voltages induced in the same configurations, this difference being not as high as one could expect from theoretical considerations. The worst-case scenario, in terms of the induced voltage at the PM input stage, has been identified both for LF and HF readers, and for two sizes of transmitting antennas. These findings may provide the basis for the definition of a standard implant configuration and a lead path to test the EMI effects of LF and HF RFID transmitters on active implantable devices.
Article
Objectives: The aim of this study was to find the electromagnetic interference (EMI) thresholds for several commonly used implantable cardioverter-defibrillators (ICD). Design: Seventeen ICDs were exposed to magnetic fields with different intensities produced by the Helmholtz coil system. Sinusoidal, pulse, ramp, and square-waveforms with a frequency range of 2 Hz to 1 kHz were used. Results: ICD malfunctions occurred in 11 of the 17 ICDs tested. The ICD malfunctions that occurred were false detections of ventricular tachycardia (6/17 ICDs) and ventricular fibrillation (3/17 ICDs), false detection of atrial tachycardia (4/6 dual chamber ICDs) and tachycardia sensing occurring during atrial or ventricular refractory periods (1/17 ICD). In most cases, no interference occurred at magnetic field levels below the occupational safety limits of the International Commission on Non-Ionizing Radiation Protection (ICNIRP). Nevertheless, some frequencies using sine, ramp or square waveforms did interfere with certain ICDs at levels below these limits. No EMI occurred with any of the ICDs below the ICNIRP limits for public exposure. Conclusion: Evaluation of EMI should be part of the risk assessment of an employee returning to work after an ICD implantation. The risk assessment should consider magnetic field intensities, frequencies and waveforms.
Article
The magnetic fields emitted by electronic article surveillance (EAS) systems (shoplifting gates) are a source of interference for implanted medical devices. In the Study of Pacemaker and Implantable Cardioverter Defibrillator Triggering by Electronic Article Surveillance Devices (SPICED TEAS), 25 adult volunteers with ICDs and 50 with pacemakers were exposed to the fields of six different EAS systems. These EAS systems used three modes of operation: magnetic audio frequency, swept radio frequency, and acoustomagnetic technology. No ICD exhibited interference mimicking sensing of tachyarrhythmias with any EAS system. Pacemakers interacted variably, depending on the type of EAS system. Swept radiofrequency systems produced no interaction with any implanted medical device. One magnetic audio frequency system interacted with 2 of 50 pacemakers. The acoustomagnetic system interacted with 48 of 50 pacemakers. Interactions included asynchronous pacing, atrial oversensing (producing “EAS induced tachycardia” in the ventricle), ventricular oversensing (with pacemaker inhibition), and paced beats resulting from the direct induction of current in the pacemaker (“EAS induced pacing”). These interactions produced symptoms in some patients (palpitations, presyncopel only while patients were in the EAS field. No pacemaker was reprogrammed. We conclude that high energy, pulsed low frequency EAS systems such as acoustomagnetic systems interfere with most pacemakers. Pacemaker patients should be advised to minimize exposure to the fields of such systems to prevent the possibility of serious clinical events.