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fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/TBME.2019.2913913, IEEE
Transactions on Biomedical Engineering
DESIGN AND EVALUATION OF A DIAPHRAGM FOR ELECTROCARDIOGRAPHY IN ELECTRONIC STETHOSCOPES 1

Design and Evaluation of a Diaphragm for


Electrocardiography in Electronic Stethoscopes
Mónica Martins, Pedro Gomes, Cristina Oliveira
Miguel Coimbra, IEEE Senior Member and Hugo Plácido da Silva, IEEE Senior Member

Abstract—Combining Phonocardiography (PCG) and Electro- a mechanical assessment, the later performs an electrical
cardiography (ECG) data has been recognized within the state- assessment, thus being complementary.
of-art as of added value for enhanced cardiovascular assessment. With auscultation being a routine exam, performed in most
However, multiple aspects of ECG data acquisition in a stetho-
scope form factor remain unstudied, and existing devices typically typical appointments with a health professional, there are
enforce a substantial change into routine clinical auscultation multiple reasons that make the combination of phonocardio-
procedures, with predictably low technology acceptance. As gram (PCG) and electrocardiogram (ECG) signals a natural
such, in this paper we present a novel approach to ECG data step. Although the combination of both modalities has been
acquisition throughout the five main cardiac auscultation points, explored in the state-of-the-art, in this paper we present a
and that intends to be incorporated in a commonly used electronic
stethoscope. Therefore, it enables analysis and acquisition of design and evaluation of a diaphragm for ECG data acquisition
both PCG and ECG signals in a single pass. We describe in an electronic stethoscope, addressing a number of practical
the development, experimental evaluation and comparison of aspects associated with this technique (as further detailed in
the ECG signals obtained using our proposed approach and a Section III).
gold standard medical device, through metrics that allow the The remainder of the paper is organized as follows: Section
evaluation of morphological similarities. Results point to a high
correlation between the two evaluated setups, thus supporting
II presents the motivation for this work, together with a
the idea of meaningfully collecting ECG data along medical brief overview of the PCG and ECG; Section III provides a
auscultation points with the proposed form factor. Moreover, review of the state-of-the-art in the field; Section IV details
this work has led us to conclude that for the studied population, the implementation of our device; Section V explains the
signals acquired on focuses F1, F2, and F3 are usually highly methodology used for experimental evaluation; Section VI
correlated with leads V1 and V2 of the standard ECG medical
recording procedure.
summarizes the results; finally, Section VII provides an outline
of the main findings.
Index Terms—Cardiovascular diseases, Electrocardiogram,
Phonocardiogram, Electronic stethoscope, Systems integration. II. BACKGROUND
A. Electrocardiogram (ECG)
I. I NTRODUCTION An electrocardiogram is a standardized medical examination
that allows the evaluation of the heart condition, through the
ccording to the World Health Organization (WHO),
A cardiovascular diseases (CVD) continue to be the leading
cause of death in the world [1]. Besides general prevention
study of its electrical activity. It is widely used due to the
high benefit/cost ratio, and also for being an easily deployable
noninvasive test. Its output consists of voltage variations as
measures that should be accounted for, regular heart monitor- a function of time, in result of the successive myocardium
ing is crucial both in chronic patients (to monitor the progress depolarization and repolarization events.
of their condition) and healthy subjects (for early detection of As the heart is formed by thousands of cells, the depo-
potential problems). larization process in each one will occur at different times.
Auscultation plays a major role in CVD’s monitoring. Given Therefore, an ECG is a relative and cumulative magnitude of
that auscultation relies on the human ear, which may not all cells in depolarization. Regardless, an ECG can be obtained
be sufficient for an accurate evaluation of the patient [2], with different configurations and electrode locations, being
phonocardiography appeared as a complement to this exam. that these will provide different perspectives of the electrical
Using electronic stethoscopes [3], a detailed recording of activity of the heart. The prototypical ECG heartbeat waveform
the heart sounds can be performed, allowing even automated is shown in Figure 1 (considering a healthy medical case), and
classification [4]. Regardless, one of the more established the typically studied leads are Lead I, Lead II, and Lead III,
techniques for CVD diagnostics is electrocardiography, by these being limb leads; aVR (augmented vector right), aVF
means of which a multi-lead assessment of the electrical (augmented vector foot), and aVL (augmented vector left),
activity of the heart is performed. While the former performs the augmented leads; and V1 to V6, the precordial leads, as
This work is funded by FCT/MEC through national funds shown in Figure 2 (right) [5].
and when applicable co-funded by FEDER PT2020 partnership An ECG analysis typically uses more than one lead, since
agreement under the project UID/EEA/50008/2013 SmartHeart. it provides different perspectives on the cardiac activity, also
All authors are with the IT - Instituto de Telecomunicações,
Portugal (e-mail: monica.cm.martins@gmail.com; pedro.tiago@lx.it.pt; increasing the probability of a good acquisition and a correct
anacristina.oliveira90@gmail.com; {miguel.coimbra, hugo.silva}@lx.it.pt) diagnosis.

0018-9294 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/TBME.2019.2913913, IEEE
Transactions on Biomedical Engineering
DESIGN AND EVALUATION OF A DIAPHRAGM FOR ELECTROCARDIOGRAPHY IN ELECTRONIC STETHOSCOPES 2

C. Motivation
The combination of both phonocardiogram (PCG) and elec-
trocardiogram (ECG) signals aims to, on one hand, enhance
PCG heart sounds segmentation capabilities based on ECG
fiducials, but also to provide richer electromechanical under-
standing of the heart in any type of scenario, further improving
the detection of cardiac diseases. The idea is to create a way
to more easily detect a cardiopathy, as an extension of the
auscultation exams already performed in a general practice by
a healthcare professional.
It is also studied if, and how, rotations of the stethocope
Fig. 1. Cardiac depolarization process and prototypical waveforms produced on the patient’s chest affect the resulting ECG signal. The
by the different components of the electrical system of the heart (extracted importance of such practice relies on the fact that an elec-
from [5]). trocardiogram is only taken under medical prescription, while
if performed as an extension of a widespread practice like
auscultation, it has the potential to be much more pervasive.
When combined, the PCG and ECG medical exams can also
improve the early detection and diagnostics of cardiopathies,
as already described in previous studies [7], [8], [9], [10].
III. S TATE - OF - THE - ART
Several devices that ally both exams have already emerged.
However, the majority of them have shown limitations, pre-
venting their standardization in medical practice. Examples
Fig. 2. Main PCG cardiac auscultation points (left), and representation of the
ECG precordial leads location (right). of such devices are the DUO from Eko or the CardioSleeve
from Rijuven, now commercially available [11], [12]. DUO
is a device that combines an electronic stethoscope and an
electrocardiograph (1-lead ECG) [13]. It can be used with the
B. Phonocardiogram (PCG)
Eko app, allowing the physician to see and review the patient’s
exam, as well as to share it with other professionals, for a
On the other hand, phonocardiography allows the represen-
second opinion. This device provides real-time waveforms,
tation of the heart sounds obtained when performing auscul-
saving and tracking possibility, as well as live streaming for
tation. Its outcome, the phonocardiogram (PCG), records the
use in telemedicine, and it can be used wirelessly (Bluetooth
cardiac sounds resulting from the mechanical response to the
is incorporated) to transmit data to smartphones, tablets or
electrical activity of the heart [6], and is usually performed
desktops [11], [13].
across the five main points depicted in Figure 2 (left).
CardioSleeve is another stethoscope that provides ECG,
It is used as a complementary exam to auscultation [2], digital auscultation and instant analysis [14]. It records four
since the latter is difficult to master [6]. The fact that it auscultation locations, using dry electrodes, and records ECG
does not allow the digital recording of any information, also leads 1-3, transmiting the data over Bluetooth to a tablet or
stands out as a major limitation in the auscultation process. smartphone. Some caveats of this device are its weight (too
Furthermore, specialized healthcare professionals are required, heavy), and the mobile application used to see the medical
in order to perform a standard medical evaluation, hence the acquisition (not fully optimized and functional).
importance of using electronic stethoscopes, which typically More work has been done in this area, giving rise to
combine auscultation and phonocardiography [3]. results such as those found in [15] and [16], which focus
In order to allow a more complete medical evaluation on developing healthcare devices that record ECG and PCG
and circumvent the lack of diagnosis equipment in some signals. Some earlier work on PCG and ECG analysis was
medical facilities, the PCG can be a compelling approach, developed, being able to create a digital phonocardiogram
especially considering that it is an extension to the standard that allows simultaneous ECG acquisition, combining both
auscultation procedures used in general medical practice. But sound and image, visualizing auscultation and enabling the
then again, this exam also has its drawbacks. The heart sound user to distinguish the location of heart sounds by ear [7]. In
has both high and low frequency signals, as well as low a more theoretical way, some studies have been more focused
amplitude, making it necessary for the stethoscope to have a on the understanding of the cardiac cycle, by performing
highly selective sensitivity. Also, the kind of data acquisition simultaneous capture of signals from multi-site auscultation
made with a stethoscope is highly affected by external noise, with the recording of an ECG, and graphic display [8],
which can mostly interfere with the final diagnosis. Finally, [9]. Also, a few projects have arised targeting the field of
the interpretation itself is higly subjective, depending on the telemedicine [10], [17].
healthcare professional and his/her experience, as well as In conclusion, several studies have found and proved that
hearing ability [3]. the underpinnings of this work, combining ECG and PCG

0018-9294 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
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Transactions on Biomedical Engineering
DESIGN AND EVALUATION OF A DIAPHRAGM FOR ELECTROCARDIOGRAPHY IN ELECTRONIC STETHOSCOPES 3

TABLE I
C USTOM DIAPHRAGMS EVALUATION CRITERIA .

Specification Classification of hearing ability


1 2 3 4 5
S1/S2
Nothing Sometimes Slightly Audible Pretty Well
Breathing
Noise Only Noise Mostly Noise A Bit of Both Mostly Sound Only Sound
Not Good Gives Some Allows Identification Allows Identification Allows Identification
General
Information After a While by a Professional by a Medical Student

Fig. 3. Line-up of all six tested diaphragm models.


TABLE II
C USTOM DIAPHRAGMS EVALUATION SUMMARY.

measurements, provides a more reliable and fast diagnosis [7], Specification Model
187 188 189 190 191 192
[8], [9], [10]. Regardless, existing devices are often cumber-
S1/S2 3.83(3) 4.167 4 3 3.667 2.667
some and disruptive to common practices in what concerns Breathing 1.83(3) 1.667 1.83(3) 1.167 1 1
their form factor when compared to standard auscultation Noise 3.33(3) 4 4 2.667 3 3
stethoscopes, and aspects such as ECG validity or influence External noise 1.83(3) 1 1.83(3) 1.667 1.167 3.83(3)
Noise vs. heart sounds 3.50 3.33(3) 3.167 3 3.50 2.33(3)
of the rotation of the stethoscope head are poorly studied.
General 3.83(3) 4 4 2.667 3.83(3) 2.167
Previous work by our team in the field of PCG has identified
the 3M Littmann 3200 electronic stethoscope [18], [19] as a
support tool with a good compromise between form factor us-
and a version with a solid filled center in the position where the
ability and technical specifications. However, this device does
acoustic sensor is mounted on the stethoscope, both produced
not have ECG data acquisition capabilities, the integration of
in thermoplastic polyurethane (TPU) (items 189-192 in Fig-
which has been done in the scope of this work.
ure 3), resembling the original silicone material of the original
Overall, in order to effectively capitalize on the routine
diaphragm (item 187 in Figure 3). In the version with a solid
practice that is auscultation using a conventional stethoscope
filled center, different thicknesses of the center were tested,
form factor (e.g. the 3M Littmann 3200) as a way of obtaining
considering the space needed to accommodate the sensor in
ECG data as a collateral to the procedure, several challenges
the diaphragm (item 191 in Figure 3) or just the electrodes
are posed. In this work we address such challenges in an end-
(item 190 in Figure 3). As a benchmark for the materials, we
to-end approach, namely by studying the diaphragm mem-
also tested versions with the exact geometry of the original
brane design to accomodate additional components (e.g. the
diaphragm printed in TPU (item 189 in Figure 3) and standard
electrodes), devising a sensor design suitable for ECG data
polylactic acid (PLA), a more rigid material commonly used
acquisition using the small footprint of the diaphragm, and
for desktop 3D printing (item 188 in Figure 3).
evaluating how the ECG signal acquired from the auscultation
points relates with the standard 12-lead ECG leads. We also The diaphragms were tested by three evaluators (two pro-
assess how the rotation of the stethoscope head with respect to fessionals and one amateur) who listened to several heart
the electrical axis of the heart affects the heartbeat waveform sounds recorded using a randomly chosen diaphragm, out of
morphology. the six already mentioned. This process was done without the
evaluators knowing what diaphragm they were using. A total
of 12 cases were studied, and multiple criteria were scored
IV. P ROPOSED A PPROACH
by the evaluators on a five-point scale. Table I describes the
A. Diaphragm criteria groups, as well as the underlying meaning of the
An important requirement for ECG data acquisition is the classification assigned to each one.
existence of an electrical interface between the sensor and the From the General evaluation values, it can be acknowledged
subject’s body, which requires direct contact with the skin and that the best classified diaphragms were the rigid PLA (trans-
can be affected by natural barriers (e.g. androgenic hair). This parent) model (188) and the flexible TPU most similar to
is not a problem on standard electronic stethoscopes, which the original model (189). Heart sounds are best heard, but
typically use silicone membranes for comfort, hygiene and the noise created by the device is amplified as well. When
providing adequate acoustic propagation capabilities. How- considering the Noise vs. Heart Sounds criteria, model 191
ever, given that PCG measures the acoustic propagation of performed better. For the rest of the diaphragms, they not only
the cardiac sounds, any barrier between the sensing element reduce the noise, but also muffle the sound. Likewise, one can
and the body surface will attenuate the signal of interest. As also verify that the 191 model showed a similar overall perfor-
such, significant attention has been given to the diaphragm mance comparing to the original version (187). Considering
design and evaluation. Several versions of the diaphragm were its classification and depth (which allowed the integration of
considered (Figure 3), all produced using standard desktop 3D some electronic components), the 191 model was chosen. To
printing, targeting the study different materials and geometries enable the interface between the ECG sensor and the subject’s
capable of accommodating some of the electronic components body, two protruding electrodes were integrated in the base of
directly in the diaphragm. the diaphragm (the two electrodes are at different potentials).
We tested three main groups of variants, namely a version Our final model, is not only true to the original diaphragm of
with a deep hollow cavity in the center (oddball hypothesis), the 3M Littmann 3200 electronic stethoscope, but also allowed

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Transactions on Biomedical Engineering
DESIGN AND EVALUATION OF A DIAPHRAGM FOR ELECTROCARDIOGRAPHY IN ELECTRONIC STETHOSCOPES 4

TABLE III A variant of the ECG sensor was therefore implemented,


E STIMATED GAINS FOR FOCUSES F1 TO F5 through which electrocardiogram signal amplitudes compati-
Focuses Max. Peak Ĝ ble with the adopted inter-electrode distance can be measured.
F1 0.052 mV 17307.69 This is further confirmed by the experimental component of
F2 0.0767 mV 11743.03 our work (see Section VI). It is important to highlight that the
F3 0.1287 mV 6993.00 sensor was used in a virtual ground configuration, to minimize
F4 0.1485 mV 6060.06 the number of contact points with the body.
F5 0.1393 mV 6460.9 While standard circuits require a grounding lead for im-
proved common mode rejection and improved signal quality, in
our design we use a virtual ground circuit, and instrumentation
for the integration of the ECG electrodes without degradation amplifiers with high input impedance and high common mode
of the signals of interest. rejection ratio (CMRR). This enables a suitable signal to be
obtained from the differential leads without the need for a
B. Analog Front End grounding lead [20], [21].
Our sensor design builds upon the BITalino (r)evolution
ECG sensor1 , which has been primarily dimensioned for the C. Data Acquisition Setup
standard ECG lead placement where the inter-electrode dis-
Given that the analog-to-digital conversion and communica-
tance is considerable. In the scope of the work, the electrodes
tion components are out of the scope of this work, for data ac-
are directly placed on the diaphragm footprint (inter-electrode
quisition from the analog front end described in Section VI.B
distance of approximately 2.5 cm), leading to a low signal
we used a variant of the BITalino (r)evolution platform and
magnitude. ECG values from an Einthoven setup (e.g.) would
supporting tools. In particular, the micro controller (MCU),
usually have an amplitude of approximately 0.11 mV, while
power management (PWR) and Bluetooth (BT) hardware
ECG values measured with the electrodes on the diaphragm
blocks were used, together with the OpenSignals (r)evolution
only reached around 0.04 mV.
software [26]. These enable sampling at up to 1 kHz with
As such, we studied the dynamics of the ECG collected at 10-bit resolution, and have been shown to have adequate
the cardiac auscultation focus, as a way to estimate the gain, performance when compared with gold standard devices [20].
targeting the modification of the analog front end of the sensor Overall, this configuration will be hereinafter referred to as
with a sensitivity more adapted to the stethoscope diaphragm SmartHeart.
setup.
The ECG being an electrical signal in nature, the positioning
VCC of the electrodes (in particular the rotation angle) of the
Rmax × G = (1) stethoscope head with respect to the electrical axis of the heart
2
will influence the morphology of the resulting measured signal.
VCC To study this effect, a second configuration for data acquisition
Ĝ = (2)
2 × Rmax system was taken into account, in order to evaluate whether
Based on experimental data, calculations were made in order (and how) the positioning angle during the auscultation exam
to estimate the most suitable gain of the analog front end influenced the resulting signal. For such purpose, the analog
for each auscultation focus. F1 to F3 remark to the farthest front end described in Section VI.B was used together with
points from the heart, and presented low amplitude signals a BITalino R-IoT device2 , due to the fact that it integrates
with the standard sensor configuration, while F4 & F5 were an onboard inertial measurement unit (IMU) and implements
usually of much higher amplitude than the latter, given the the attitude estimation algorithm by Sebastian Madgwick [22].
heart proximity. This device enables data acquisition at up to 200 Hz with 12-
The sensor gain was estimated taking into account that the bit resolution, and will be hereinafter designated as R-IoT.
ECG signal is centred in V2cc , and that its amplitude must It is important to highlight that both the SmartHeart and the
be multiplied by a certain gain G, in order to achieve the R-IoT configurations have uniquely advantageous properties
intended value (Equation 1). Table I summarises the result for our work, hence the need for the two. On one hand
of this analysis, showing the most appropriate gain for each the SmartHeart configuration provides high time resolution
focus. The main conclusion is that, ideally, the sensor should and suitable amplitude resolution, but it lacks information
have an adjustable gain in order to have the best performance, regarding the rotation angle of the device. On the other
given the disparity of amplification gains required in-between hand, the R-IoT configuration allows the measurement of the
focuses. diaphragms angle in space, with respect to the earth’s magnetic
In the scope of our work, however, we used a fixed gain pole, but it provides a much lower time resolution. Given that
compatible with the dynamic range of the signals obtain across the ECG data analysis is only dependent on the diaphragm, the
focuses. Considering previous calculations, and to prevent data acquisition setups were integrated in a stethoscope form
saturation of most restrictive signal (F4), 5600 was used as factor simulator, in which the diaphragm base integrated the
a conservative gain value for the proposed setup. electrodes and worked as the interface with the subjects body,
1 http://bitalino.com/datasheets/REVOLUTION ECG Sensor Datasheet.pdf 2 http://bitalino.com/en/r-iot-kit

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Transactions on Biomedical Engineering
DESIGN AND EVALUATION OF A DIAPHRAGM FOR ELECTROCARDIOGRAPHY IN ELECTRONIC STETHOSCOPES 5

time, with positioning done according to personal preference


of the experimenter. With the R-IoT, 90◦ angle variations
between each position, and for each focus, were considered;
in particular, 90◦ rotation clockwise: 0◦ ; vertical after another
90◦ rotation: -90; horizontal after a final 90◦ rotation: -180◦ .
A total of 15 volunteers (5 of which women) with an average
of 26 ± 4.46 year old were enrolled in the experiment, from
which 60 ECG signal traces were considered (10 for the GE
Fig. 4. R-IoT stethoscope form factor simulator. Left: Top view of the device
showing the battery, acquisition and communication electronics inside; Center: MAC 800, 10 for the SmartHeart simulator and 40 for the R-
Side view of the device showing the grip used to apply the simulator to the IoT simulator, i.e. one per rotation). The recordings for some
device; Right: Bottom view of the device showing the electrodes configuration. of the subjects were discarded, due to setup conditions and
specific physiological and anatomical features that prevented
the attainment of a good quality acquisition to allow a fair
with the interior of the diaphragm housing the electronics
comparison between systems. Human subjects approval was
(Figure 4).
granted in accordance with the standard procedures followed
Two simulators were created, one with the SmartHeart
by our institutional review board.
hardware base and another with the R-IoT. Both have a
lithium-polymer (LiPo) battery, and a pair of gold alloy elec-
trodes, which are assembled on a thermoplastic polyurethane B. Post-Processing
(TPU) diaphragm (which, as described in Section VI.A, Filtering, R-peak detection within each ECG segment, and
has shown suitable performance when compared with the heartbeat waveform segmentation were performed using the
default diaphragm). For our proposed approach, the typical BioSPPy toolbox3 [26]. Within this toolbox, the module
Ag/AgCl electrodes could not used, because their physical ecg.py contains a set of functions for feature extraction and
characteristics and geometry do not allow proper moulding segmentation, which were used to support the post-processing
and adaptation to the specific mechanical characteristics of the component of the work. In terms of filtering, we used a band-
3M Littmann 3200 stethoscope diaphragm form factor, without pass finite impulse response (FIR) with order corresponding
interfering with the usability of the device and performance of to 30% of the sampling rate, which has been identified as a
the PCG signal acquisition component [19]. Gold enabled us to suitable approach in previous work by our group. For R-peak
overcome these limitations, and has been shown to have good detection, the algorithm following the approach by [27] was
performance when used for measuring biopotentials, including used.
electrocardiography signals [23], [24], meeting the standards For the heartbeat waveforms extraction (herein also desig-
for our particular application, namely high conductivity, easy nated templates), which are a segment of the signal in time,
to mould into the shapes found suitable for our proposed corresponding to a heart beat cycle, a criteria that selects 0.2 s
approach, and possibility to obtain in a miniaturized size, before the R peak and 0.4 s after is used, taking into account
this being an important feature for the integration in the the known physiological time intervals for a heart rate at rest.
diaphragm form factor. Furthermore, gold is considered a
reference material for some biosignals measurements. VI. R ESULTS
In terms of data analysis, we based our study on mor-
V. E XPERIMENTAL M ETHODOLOGY phological waveform analysis. For that purpose, the average
A. Data Acquisition on Subjects heartbeat waveform was obtained for each of the twelve
Our proposed setup was tested against a medical-grade gold leads acquired with the gold standard, and for each of the
standard, with the goal of evaluating its performance. Whilst five auscultations points of both the SmartHeart and R-IoT
the standard 12 leads ECG and electrode placements used in simulators. The goal was to determine which (if any), and how,
regular practice are fully characterized in literature, the setup leads of the standard ECG have a morphological resemblance
devised in the scope of this work has several properties that with the data acquired with the non-standard procedures and
make it significantly different from both the standard 12 lead sensor placements followed in our approach. Two studies were
ECG and from other approaches found in the state of the art. performed, namely analysis of the correlation with the standard
In particular, the electrode material and geometry, inter- placement and the assessment of the effect of rotation in the
electrode spacing, and the lack of a ground/reference lead are waveform morphology. A standard ECG waveform collected
all non-standard approaches, motivating the study of the valid- in the main auscultation points is represented in Figure 5, to
ity of the collected data. For the experimental data acquisition, provide a visual reference to the obtained morphologies.
only healthy subjects were evaluated, under the guidance of
a cardiopneumologist, and the adopted gold standard device A. Correlation with Standard Placement
was the MAC 800 [25], from General Electric (GE). After processing all data from the SmartHeart device,
The overall setup consisted of a GE MAC 800, SmartHeart values of the coefficient of determination (R2 ), for each of
and R-IoT stethoscope simulators. With the gold standard all the 12 leads, and for each focus, were used to assess the
twelve leads were acquired, while with the simulators ECG
signals were collected in all five auscultation points, one at a 3 https://github.com/PIA-Group/BioSPPy

0018-9294 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
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Transactions on Biomedical Engineering
DESIGN AND EVALUATION OF A DIAPHRAGM FOR ELECTROCARDIOGRAPHY IN ELECTRONIC STETHOSCOPES 6

subjects. From the numerical results, F1 has lead V2 as the


most similar with R2 = 0.7607 ± 0.1401, as well as F2 and
F3 with R2 = 0.8646 ± 0.0504 and R2 = 0.8421 ± 0.0520,
respectively, F4 has lead V5 as the most similar with R2 =
0.7490 ± 0.0928, and F5 has lead aVF as most similar with
R2 = 0.7158 ± 0.2383. These results have been determined
based on the highest R2 values for each focus.
As shown by the numerical results, focuses F1 to F3 were
readily identified with leads V2. This could be explained by the
electrodes’ positioning factor involved. The first three focuses
are located above the heart, while focuses F4 and F5 are below
the heart, and closer to it. Similarly, leads V1, V2 and even
V3 are acquired at the middle of the chest, also above the
heart.

B. Evaluation of the Effects of Rotation


In addition to the SmartHeart prototype, R-IoT data was
also processed and analysed. The same set of metrics was
adopted: R2 calculation, this time for each of the 12 leads,
5 focuses and 4 rotations (vertical: 90◦ ; horizontal after 90◦
rotation clockwise: 0◦ ; vertical after another 90◦ rotation: -
Fig. 5. Filtered ECG signals acquired for focuses F1 to F5 in a randomly
90◦ ; horizontal after a final 90◦ rotation: -180◦ ). Figure 7
selected case study, normalized by the highest amplitude across focuses. illustrates the results for all case studies, for focus F5. A
morphological analysis was also carried, in order to predict
which lead resembles more to each position of this focus. This
morphological similarity between the heartbeat waveforms. type of reasoning was applied throughout all signals, and all
Multiple analysis were performed, in order to understand the focuses. In the end, this information can be cross linked with
behaviour and correlation between auscultation focuses and SmartHeart results for the same volunteer, in order to verify if
gold standard leads’ signals. R-peaks were detected, and the the same correlation between focus and lead occurs for both
heartbeat waveforms segmented as previously described, to devices.
get a representative description of the morphological pattern
in each focus.
We also present a plot with both MAC 800 and SmartHeart
ECG signals. This was done for each individual lead (I, II,
III, aVR, aVL, aVF, V1, V2, V3, V4, V5 & V6) and for each
focus (F1, F2, F3, F4 & F5). Mean waves were calculated, as
well as the SmartHeart’s data standard deviation (an example
of the signal waveforms for one focus analysis is depicted as
the dotted line in Figure 6).
The purpose of evaluating statistical metrics was the iden-
tification of the gold standard lead that presents the highest
morphological resemblance to each focus signal. In Figure 6,
for example, even visually, a resemblance between leads V1
& V2 (MAC 800) and the SmartHeart signal is apparent.
Numerical analysis was performed to study these relations
in depth. From the adopted metrics, it is possible to identify
a corresponding lead according to the computed values. To
proceed this study, both MAC 800 and SmartHeart heartbeat Fig. 7. Overlapped heartbeat waveforms for focus F5 with the simulator
waveforms were analyzed for morphological resemblances. placed at different rotations.
This analysis was crossed with the electrodes positioning, for
each lead and focus. Taking focus F5 as example, for this case study, numerical
Results point to similarities between focuses F1 to F5 and results mostly pointed to lead V6 as most similar, for the four
one or more leads, according to the numerical results obtained. rotations in general. One could come to a conclusion that in
With this, the intent was to look for similarities between focus F5, ECG signals are numerically more similar to lead V6
empirical data and numerical data. In order to eliminate for a 90◦ and -90◦ position with R2 = 0.9578 ± 0.0107 and
the potential effect of rotation as an additional variable, the R2 = 0.9160 ± 0.0132, respectively, to lead aVL for -180◦
stethoscope simulator was applied in the same position across with R2 = 0.9194 ± 0.0306, and lead V1 for a 0◦ rotation

0018-9294 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/TBME.2019.2913913, IEEE
Transactions on Biomedical Engineering
DESIGN AND EVALUATION OF A DIAPHRAGM FOR ELECTROCARDIOGRAPHY IN ELECTRONIC STETHOSCOPES 7

Fig. 6. Representation of MAC 800 mean waveforms and their templates (in red) overlapped with the SmartHeart heartbeat waveforms and their templates,
as well as standard deviation for focus F3 (in blue).

angle with R2 = 0.4373 ± 0.3921, these being the leads with and so on. In theory, the electrodes may be placed distally or
the highest coefficients of correlation. proximally to the source without affecting the recorded output,
Another important aspect of this analysis is the influence due to the dynamics of progression of the depolarization
that rotation angles have in the polarity of the ECG signal. This wavefronts (although the measured voltage potential difference
was the main purpose of using the R-IoT for different angle will depend on the distance between electrodes).
variations throughout the five medical auscultation points. As In our approach, the gain and filtering characteristics are
expected, inversion of the signal was readily observed when such that even with a 2.5 cm inter-electrode distance it is
the device changed positions. possible to measure the depolarization wavefront locally and
without the need for an external earth ground. By rotating the
stethoscope head, the differential leads are placed in different
C. Discussion alignments with respect to the electrical axis of the heart.
Our work uses an analog front end for bipolar differential Within the experimental component of the work we sought to
ECG sensing capable of being integrated in the footprint of a evaluate the relation between these different alignments and
stethoscope head, without degradation of the PCG signal. In those obtained with the standard lead placement. Our research
such setup, for a given focus, the rotation of the stethoscope question for this should be seen as “Can these stethoscope
head (and consequently the differential leads) with respect placements used for auscultation be used as opportunistic
to the electrical axis of the heart will measure the cardiac captures of valid ECG lead surrogates?”.
depolarization wavefronts at different angles.
As originally set forth by Einthoven, the positioning of VII. C ONCLUSION
the electrodes with respect to the electrical axis of the heart Our work resulted in a novel form factor for ECG acqui-
will capture different perspectives of its electrical conduction sition capable of being integrated in a 3M Littmann 3200
system. For example, Lead I provides a RA-LA lateral view at electronic stethoscope, which has been benchmarked against a
0◦ angle, Lead II provides a RA-LL inferior view at 60◦ angle, gold standard device. Synchronization between ECG and PCG

0018-9294 (c) 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/TBME.2019.2913913, IEEE
Transactions on Biomedical Engineering
DESIGN AND EVALUATION OF A DIAPHRAGM FOR ELECTROCARDIOGRAPHY IN ELECTRONIC STETHOSCOPES 8

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