eko EMAS Murmur Analysis Software User Manual
- June 14, 2024
- EKO
Table of Contents
eko EMAS Murmur Analysis Software
Introduction
This manual is intended to provide information to guide trained operators in the safe and effective operation of the Eko Murmur Analysis Software. You must read and understand all instructions in this manual before operating the device and pay careful attention to the warnings and cautions throughout the manual.
Caution
United States Federal law restricts the sale and use of this device either by
or on the order of a clinician. Eko Health, Inc., assumes no responsibility
for any injury to anyone, or for the improper use of the product that may
result from failure to use this product by the instructions, cautions,
warnings, or statement of intended use published in this manual. Eko Health,
Inc., may have patents, patent applications, trademarks, copyrights, or other
intellectual property rights covering subject matter in this document. The use
of this document does not give anyone a license to these patents, trademarks,
copyrights, or other intellectual property.
For Help and Assistance
For general and product-related comments, questions, or concerns, please
contact Eko directly. Please report any injury or adverse event to Eko using
any of the contact methods below.
Serious Incident Reporting
If a serious incident has occurred about the device, it should be reported to
the manufacturer and the competent authority of the Member State in which the
user and/or patient is established. A serious incident means any incident that
directly or indirectly led, might have led or, in case of recurrence, could
lead to any of the following: the death of a patient, user or another person,
the temporary or permanent serious deterioration of a patient’s, user’s, fetus
or other person’s state of health, or a serious public health threat.
Eko Murmur Analysis Software (EMAS)
Manufacturer’s Address:| Eko Health, Inc.
2100 Powell St., Suite 300 Emeryville, CA 94608, USA
---|---
General Assistance and FAQs:| ekohealth.com/ifu
Direct Contact:| support@ekohealth.com
Phone Support:| +1.844.356.3384 (US)
Product Reference and Information:| ekohealth.com
Patents:| Listing of applicable U.S. Patents in compliance with 35
U.S.C.
§287:
ekohealth.com/patents
Disclaimer:| The information contained in this document is subject to change without notice.
Safety-Related Labels & Symbols
Cautions
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This is not a diagnosis, only a possible finding. Recording and analyzing all auscultation positions is recommended before making a diagnosis. The interpretations of heart sounds offered by the Eko Murmur Analysis Software are meant only to provide clinical decision support to the clinician, who may use the result in conjunction with their evaluation and clinical judgment. The interpretations are not diagnoses.
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The Eko Murmur Analysis Software can provide automatic computer interpretations.
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A computer-generated interpretation cannot replace sound medical reasoning by a trained professional. Therefore, a physician should always review the interpretation and final analysis should always be obtained
by a physician. Proper administration and implementation of this device is the physician’s responsibility. -
The quality of the computer interpretations depends heavily upon the quality of the inputted data. Only analyze high-quality recordings of heart sounds.
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The software only informs the clinician about the presence or absence of murmurs in the phonocardiogram, and if present, whether those murmurs are systolic or diastolic, and structural or innocent. The physician should conduct a more complete analysis of the detected murmur to determine from which valve(s) it emanates and the degree of disease severity it indicates. This may require additional testing, as indicated.
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The Eko Murmur Analysis Software is not intended as a sole means of diagnosis. The detection of abnormalities in heart sounds offered by the software are only significant when used in conjunction with physician interpretation.
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The software has been trained using sound recordings taken from the four standard cardiac auscultation positions (i.e., right upper sternal border, left upper sternal border, left lower sternal border, and cardiac apex). Device performance is unknown when analyzing sounds captured from elsewhere on the patient’s body.
Indications/Intended Purpose
The Eko Murmur Analysis Software is intended to provide decision support to
clinicians in their evaluation of patients’ heart sounds. The software
analyzes heart sounds and phonocardiograms (and ECG signals, when available).
The software will automatically detect murmurs that may be present, and the
murmur timing and character, including S1, S2, innocent heart murmurs,
structural heart murmurs, and the absence of a heart murmur.
The Eko Murmur Analysis Software is not intended as a sole means of diagnosis and is for use in environments where healthcare is provided by clinicians. The interpretations of heart sounds offered by the software are meant only to provide decision support to the clinician, who may use the result in conjunction with their evaluation and clinical judgment. The interpretations are not diagnoses. The Eko Murmur Analysis Software is intended for use on pediatric and adult patients.
Intended Users
The Eko Murmur Analysis Software is intended for clinician use on pediatric
and adult patients.
Compatibility
For compatible Eko hardware and mobile devices, please refer to System
Requirements at ekohealth.com.
Other Considerations
This manual provides instructions for the use of the Eko Murmur Analysis
Software. It is assumed that the user is familiar with basic Eko software
applications used on mobile and desktop devices. Standard procedures for
auscultation should be followed including background noise reduction and
optimal patient positioning when capturing data for the Eko Murmur Analysis
Software. Notifications made by this feature are potential findings and are
not a complete diagnosis of cardiac abnormalities. The patient’s medical
history and physical examination results must be taken into consideration
during the decision-making process.
The Eko Murmur Analysis Software is unable to return a result if the Eko CORE,
CORE 500™, or DUO stethoscope is unable to connect to the mobile device over
Bluetooth or if the mobile device is unable to connect to the internet. The
Eko Murmur Analysis Software requires a minimum internet connection speed. The
recommended upload speed for the mobile app is 4 Mbps. 4G cellular data
service or similar is recommended.
The software should not be used on patients where the physician has difficulty
auscultating with the Eko CORE, CORE 500™, or DUO stethoscopes. Software
accuracy may suffer when the patient is obese or has loud pulmonary sounds.
Final judgment on the diagnosis still lies with the qualified medical
personnel.
Technical Description
Murmur Characterization
The Eko Murmur Analysis Software (EMAS) identifies possible murmurs in a heart
sound recording, and if present, whether those murmurs are systolic or
diastolic, and innocent or structural. These are not diagnoses, only potential
finding(s). If indicated, you should conduct a further evaluation if a murmur
is detected. A murmur finding is often a recommendation for echocardiography
or specialist referral. The EMAS will only function if the user has subscribed
to the appropriate Eko software package, and the package has been activated on
the user’s account. Once activated, the EMAS will function automatically,
immediately after the user takes a sound recording. (The recording must be at
least 5 seconds long.)
Once the recording has been completed, the Eko companion mobile application will invoke the EMAS and the results of the analysis will be displayed on the Eko mobile application in less than 10 seconds. No user intervention is needed to initiate, complete, or display the analysis. The Eko Murmur Analysis Software will display to the user these possible results, examples of which are shown in Figure 1:
- Poor quality heart sounds
- No murmur detected
- Systolic murmur detected
- Diastolic murmur detected
- Innocent murmur detected
- Structural murmur detected
The causes of systolic murmurs vary; where the murmur is heard the loudest can help in diagnosis. Aortic stenosis, atrial septal defect, and pulmonic stenosis are heard best at the left and right upper sternal borders, whereas mitral regurgitation is heard best at the cardiac apex. These structural (pathologic) murmurs warrant referral to a cardiologist for further evaluation.1–3 Diastolic murmurs, such as those caused by mitral stenosis or aortic regurgitation, are heard best at the cardiac apex and are also structural (pathologic) and warrant further evaluation, including referral to a cardiologist. Innocent systolic murmurs, like Still’s murmur,are common in children and often disappear by adulthood. Depending upon the clinical situation, some clinicians may follow these patients with repeat auscultation Clinicians should refer to recommended clinical management guidelines to determine appropriate actions for innocent and structural murmurs.
Note
Proper handling of the Eko digital stethoscope (the CORE, CORE 500™, or DUO)
to minimize external background noise and hand rub/clicks should be practiced.
Note
The software will not detect cardiac conditions that do not cause heart
murmurs.
Note
All heart sound listening positions should be analyzed before making a
referral decision.
Note
This software does not analyze lung sounds.
Note
In some circumstances, EMAS may incorrectly identify a continuous heart murmur
as either systolic or diastolic. However, clinical decision-making should not
be affected, as the device will correctly identify continuous heart murmurs as
‘structural’ 85.6% of the time based on our clinical validation.
References
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Alpert MA. Systolic Murmurs. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd ed., Boston: Butterworths; 1990.
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Chorba JS, Shapiro AM, Le L, Maidens J, Prince J, Pham S, et al. Deep Learning Algorithm for Automated Cardiac Murmur Detection via a Digital Stethoscope Platform. J Am Heart Assoc 2021;10:e019905. doi:10.1161/ JAHA.120.019905.
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Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, Gentile F, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2021;143:e35–e71. doi:10.1161/ CIR.0000000000000932.
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Choi HJ. Evaluation and diagnostic approach for heart murmurs in children. J Korean Med Assoc 2020;63:398–403. doi:10.5124
jkma.2020.63.7.398. -
Frank JE, Jacobe KM. Evaluation and management of heart murmurs in children. Am Fam Physician 2011;84:793–800.
Clinical Performance Summary
The Eko Murmur Analysis Software has been validated using retrospective
analysis on a proprietary database. The database contains 2,380 unique heart
sound recordings from 615 unique subjects. In the proprietary database, all
heart sound recordings were collected using the Eko CORE (67.6%) or Eko DUO
(32.4%) digital stethoscopes. The subject population was 42.6% female and had
an age range of 0 to 95 years old. Race was recorded in 45% of the subjects
and out of that subset, 98% were white, 1.5% were African American and 0.7%
were Asian. No complications or adverse events were experienced during the use
of the EMAS device.
All recordings were annotated by multiple cardiologists with respect to their
quality and the presence of any murmur.
Of the recordings identified as being good signals by the expert cardiologists, 45.8% had a confirmed structural murmur and 54.2% had a confirmed no murmur or innocent murmur. Ground truth for murmur classification was obtained via pairing cardiologist annotations with gold standard echocardiogram. Additionally, 299 heart sound recordings were annotated by expert cardiologists to obtain the timing of the S1 and S2 sounds. Cardiologists were blinded to all subject demographic data and echocardiogram findings during annotation. No study subjects included in the training datasets were included in the test database. All algorithm testing was performed once the final EMAS version was locked. The following tables demonstrate the results of the primary performance analyses (Murmur Classification and Heart Sound Timing).
Table 1. EMAS Murmur Classification Performance
Table 2. EMAS Heart Sound Timing Performance
Sensitivity (%) PPV (%)
| S1 Detection| 96.2| 97.1
| | (95% CI: 94.9 – 97.4)| (95% CI: 96.3 – 98.0)
Heart Sound Timing| | |
| S2 Detection| 92.3| 94.3
| | (95% CI: 90.3 – 94.3)| (95% CI: 93.4 – 95.1)
Table 3. Expected EMAS Performance Across Age-ranges²
| Expected Prevalence6 (%)| Sensitivity (%)| Specificity
(%)| PPV (%)| NPV (%)
---|---|---|---|---|---
age ≤ 18| 5| 82.0| 82.9| 22.3| 98.9
age > 18| 20| 90.2| 90.6| 70.6| 97.4
Assuming a structural murmurs prevalence of 5% in pediatrics, we expect to see a PPV of 22% and an NPV of 99%. Namely, 22% of the recordings where the algorithm returns a positive finding are expected to have a true structural murmur and 99% of the recordings where the algorithm returns a negative finding are expected to not have a structural murmur. Similarly, assuming a structural murmurs prevalence of 20% in adults, we expect to see a PPV of 60% and an NPV of 97%. Namely, 60% of the recordings where the algorithm returns a positive finding are expected to have a true structural murmur and 97% of the recordings where the algorithm returns a negative finding are expected to not have a structural murmur.
The algorithm performs better at detecting murmurs with a high grade. In addition, the algorithm shows higher sensitivity on recordings where a panel of cardiologists agrees that a murmur is present (Sensitivity = 88%, Specificity = 83%). Sensitivity is lower on recordings where a panel of cardiologists cannot reach an agreement and an additional cardiologist was used for final confirmation (Sensitivity = 25%, Specificity = 87%).
Table 4. Diastolic Murmur Detection Performance
References
Menashe, V. (2007). Heart murmurs. Pediatrics in Review, 28(4), e19-e22.
Eko App
Download the Eko App, available on the App Store® or Google Play Store® and
follow the on-screen setup instructions to access the Eko Mumur Analysis
Software.
Regulatory Information
Eko Health, Inc
2100 Powell St., Suite 300 Emeryville, CA 94608 USA
www.ekohealth.com
Authorized UK Responsible Person: Emergo Consulting (UK) Limited
c/o Cr360 – UL International Compass House, Vision Park Histon Cambridge CB24
9BZ
United Kingdom
2023 Eko Health, Inc. All rights reserved
Eko, the Eko logo, CORE, and DUO are trademarks of Eko. Other company and
product names may be trademarks of their respective owners. LBL295 Rev 3.0 –
Issue Date: October 2023
References
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