2023 IEEE International Symposium on Antennas and Propagation and USNC-URSI Radio Science Meeting (USNC-URSI) | 978-1-6654-4228-2/23/$31.

00 ©2023 IEEE | DOI: 10.1109/USNC-URSI52151.2023.10237415

Full Wave Analysis of the Exposure of Implantable

Medical Devices to Electromagnetic Fields
J. L. Duque(1) , R. Urbina(2) , M. R. Perez(2) , and J. L. Araque(1)
(1)
Dept. of Electrical Engineering Universidad Nacional de Colombia, Bogotá 111321, Colombia
(2)
Dept. of Electronics Engineering, Pontificia Universidad Javeriana, Bogotá 110231, Colombia

Abstract—We present numerical results on the exposure of where ηc is the impedance of the human body, PT is the
Implantable Medical Devices to electromagnetic fields produced transmission power, GT is the antenna gain, R is the distance
by radio communication systems in common usage scenarios. between the antenna and the human body, τ is the transmission
Initially, a theoretical model based on simple formulas provides
an order-of-magnitude assessment to identify critical cases that coefficient, ϵr is the relative permittivity, α is the attenuation
require further analysis. Subsequently, full wave analysis is factor and z is the distance between the edge of the body and
carried out considering the detailed composition of the body the IMD.
of the patient bearing the Implantable Medical Device (IMD), The human body was modeled as a homogeneous block
the source of electromagnetic field, and the characteristics of the whose dielectric constant results from the weighted average
IMD.
assuming this composition: 30% blood, 40% muscle, 20%
I. I NTRODUCTION bone, and 10% fat. To determine the dielectric properties of
the tissues of the human body, the IFAC-CNR database was
The widespread use of wireless systems nowadays causes used [6].
people to be in prolonged exposure to the electromagnetic
fields generated by these systems. Therefore, the Electromag-
netic Compatibility (EMC) between these devices and wireless
systems is of great interest to manufacturers and users of
Implantable Medical Devices (IMDs), and regulators alike in
order to prevent failures in IMDs that may cause a risk to the
patient [1]–[4].
In this paper, we analyze practical situations where a
patient bearing an IMD is exposed to an electromagnetic
field produced by a wireless system. Initially, we carry out
computations based on a simplified theoretical model to assess
Fig. 1. Simplified theoretical model of interaction between wireless systems
the order of magnitude of the exposure field. Subsequently, and IMDs.
we perform a detailed computational analysis that correctly
accounts for the source of the electromagnetic field, the Twelve different types of wireless communication technol-
patient’s body and the geometry and materials of the IMD. ogy were analyzed, among these are mobile phone, walkie-
talkie, RFID and others. The operating parameters were de-
II. T HEORETICAL MODEL fined according to the pertinent regulations in Colombia. The
IMDs analyzed were cardiac pacemakers and defibrillators due
According to the IEC 60601-1-2 standard, medical devices
to their importance as life supporting devices.
operating in home environments must be immune to electric
Table I shows the results of the theoretical computation
fields of magnitude 10V/m in the 80MHz - 2700MHz band,
for the most relevant wireless communication technologies
and for wireless systems, the immunity to electric fields
causing exposure on IMDs.
varies from 9V/m to 28V/m for frequencies in the band
Three of the scenarios presented in Table I exceed the
from 380MHz to 5800MHz [5] depending on the specific
generic limit of 10V/m, however, it does not exceed the
technology considered.
specific limit of wireless technology, which for all three cases
Considering the limits of the IEC 60601-1-2 standard, an ap-
is 28V/m.
proximate theoretical model was used to calculate the electric
field in the IMD to determine if the wireless communication III. S IMULATION SETUP AND RESULTS
system can exceed these limits.
The full-wave analysis was carried out Sim4Life, which
The electric field at IMD, assuming normal incidence in all
is a software package based on the Finite Difference Time
cases, is calculated as follows:
Domain (FDTD) method for electromagnetic analysis. This
!1/2 package enables the use of detailed computational models
1/2
τ e−αz ηc PT GT ϵr of the human body that include the relevant features of the
EIM D = (1)
R 2π various human tissues, and can also model the thermal effects

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 TABLE I
T HEORETICAL ASSESSMENT OF THE EXPOSURE OF IMD S TO
ELECTROMAGNETIC FIELD OF SOME WIRELESS SYSTEMS .

Wireless f PT WC WIM D EIM D

communication [MHz] [dBm] [dBm/m2 ] [dBm/m2 ] [V/m]
Mobile phone, UE,
850 33.0 38.496 34.203 17.483
Low Frequency
Mobile phone, UE,
2600 23.0 28.486 19.792 3.371
High Frequency
BTS, Low frequency 850 44.0 37.204 29.563 10.247
BTS, High frequency 2600 44.0 37.284 25.325 6.374
Walkie Talkie 467 33.0 40.486 33.948 16.90
Radio, Low frequency 0.54 84.0 37.507 27.074 3.075
Radio, High frequency 108 80.0 24.907 18.756 2.821

of the electromagnetic interaction [7]. Finally, the pose of the

human body can be set in agreement to each use (e.g. standing,
sitting, holding a User Equipment (UE)).
For brevity, we present here the results of the scenario with
the highest electric field intensity from Table I, that is, mobile
phone, UE, low frequency. The mobile device consists of a
metal box with dimensions 71.5mm x 7.4mm x 146.7mm
which corresponds to a commercial model, on which is located
an inverted F-type antenna which resonates at 850MHz. The
power of the device is 2W, according to the standards for 2G
and 3G cellular systems.
The anatomical model used is the ”Duke” model, which
resembles a 34-year-old man, with a height of 1.77 meters
and a weight of 70.3 kg [8].
A CAD model of the pacemaker was made emulating
the Insignia I Ultra Model 1291, which has the following
dimensions: 43mm x 49mm x 8mm [9]. The upper part is made
of polyurethane, while the lower part is made of titanium. The
IMD was placed below the left clavicle, and its wires, with
a diameter of 2.4 mm and a length of approximately 30 cm,
were placed inside the veins until they reached the heart.
Fig. 2 displays a planar axial cut (XY plane) of the electric
field across the body (Z = 1494.50 mm), evaluated according to
the IEC 60601-1-2 standard. The electric field does not exceed
the specific limit of the technology (28V/m), moreover it is
not concentrated in the vicinity of the IMD, but is present on
the arm and on the back of the anatomical model.
IV. C ONCLUSION
Our assessment of the wireless exposition of IMDs to elec-
tromagnetic fields produced by radio communication systems
shows that in all cases the levels conform to the relevant
standards. Given that IMD manufacturers will usually employ
some safety margin with respect to these standards, it would
appear that common exposure scenarios pose no risk to the
patients, i.e. when usage is in agreeement with the manufac-
turer’s indications.
Fig. 2. Coronal axial of the electric field across the IMD with field due to a
cellular UE. (Z = 1494.50 mm).
for the Sim4Life for Science license granted to Universidad
Nacional de Colombia.
R EFERENCES
[1] W. Kainz, G. Neubauer, F. Alesch, G. Schmid, and O. Jahn, “Electro-
magnetic compatibility of electronic implants–review of the literature,”
Wien Klin Wochenschr., vol. 113, no. 23-24, pp. 903–914, 2001.
[2] D. Witters, “Facing the challenges of electromagnetic interference with
medical devices in the wireless world,” XXVIth URSI General Assembly,
Maastricht, the Netherlands, Aug 2002.
[3] W. Kainz, J. P. Casamento, P. S. Ruggera, D. D. Chan, and D. M. Witters,
“Implantable cardiac pacemaker electromagnetic compatibility testing in
a novel security system simulator,” IEEE Transactions on Biomedical
Engineering, vol. 52, no. 3, pp. 520–530, 2005.
[4] I. L. Spano, S. Sulis, A. Serpi, I. Marongiu, and G. Gatto, “Emc character-
ization of implantable cardiac medical devices in an anechoic chamber,” in
2014 International Symposium on Electromagnetic Compatibility, 2014,
pp. 872–877.
[5] “IEC International Standard - Medical electrical equipment - part 1-
2: General requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances - Requirements and
tests,” IEC 60601-1-2:2014, 2014.
[6] D. Andreuccetti, R. Fossi, and C. Petrucci, “An internet resource for the
calculation of the dielectric properties of body tissues in the frequency
range 10 Hz - 100 GHz,” IFAC-CNR, Florence (Italy), 1997, based
on data published by C. Gabriel et al. in 1996. [Online]. Available:
http://niremf.ifac.cnr.it/tissprop/
[7] “Sim4life,” ZMT Zurich MedTech AG. [Online]. Available: https:
//zmt.swiss/sim4life/
[8] “ITIS Human Models Overview,” ITIS Foundation. [Online]. Available:
https://itis.swiss/virtual-population/virtual-population/overview
[9] “INSIGNIA® I Ultra MODELS 1190/1290/1291 system guide,”
Guidant. [Online]. Available: https://www.bostonscientific.com/content/
dam/Manuals/us/current-rev-en/355668-006 S.pdf

ACKNOWLEDGEMENT
This work was funded by the Agencia Nacional del Espec-
tro, Colombia, in the framework of Convocatoria de Investiga-
ciones 2022. Authors are grateful to ZMT Zurich MedTech AG

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