Eko Analysis Software User Manual

Eko Analysis Software

Product Information

• The Eko Analysis Software is a software application designed to interpret heart sounds and ECG readings. It is intended to be used by trained operators and is not the sole means of diagnosis. The software is for use on adults (> 18 years) and should be used in\ conjunction with physician over-read.
• The quality of the ECG readings is dependent on proper preparation practices, including body hair, skin dryness, and clean contact area. The software requires a minimum internet connection speed of 4000 Kbps for the mobile app and 4G cellular data service or similar is recommended. It is highly recommended to use device and networking security features to protect patient data created and stored using this software.
• Eko Devices, Inc. assumes no responsibility for any injury or improper use of the product that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statements of intended use published in the manual. The use of this document does not give anyone a license to the patents, trademarks, copyrights, or other intellectual property rights covering the subject matter in this document.

Product Usage

Before operating the Eko Analysis Software, it is important to read and understand all instructions in the manual and pay careful attention to the warnings and cautions throughout the manual.

The software should be used by trained operators and should not be used as a sole means of diagnosis. Standard procedures for auscultation should be followed, including background noise reduction and optimal patient positioning when capturing data for the Eko Analysis Software.
It is recommended to use device and networking security features to protect patient data created and stored using this software. If you experience any issues or have any questions regarding the product, contact Eko directly using the provided contact methods.

Introduction

• This manual is intended to provide information to guide trained operators in the safe and effective operation of the Eko Analysis Software. It is important that you 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 : Federal (USA) law restricts this device to sale to or on the order of a clinician.

• Eko Devices, Inc.. assumes no responsibility for any injury to anyone, or improper use of the product,
  that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statements of intended use published in this manual.

• Eko Devices, Inc. may have patents, patent applications, trademarks, copyrights, or other intellectual property (IP) rights covering the 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.

• Manufacturer’s Address:
  Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 USA

• General Assistance and FAQs
  ekohealth.com/getstarted

• Direct Contact
  support@ekohealth.com

• Phone Support
  +1.844.356.3384

• 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

• Instructions for use
• Model number
• Manufacturer
• EC Representative

Cautions

• This is NOT a diagnosis. Findings from the Eko Analysis Software are only meaningful in conjunction with clinician over-read and interpretation. This software is not intended to be the sole means of diagnosis.
• The Eko Analysis Software can provide automatic computer interpretations. 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, diagnosis and implementation of the test 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 ECG and heart sounds.
• Clinicians should look at all outputs: rhythm classification, heart rate, and QRS interval before making an interpretation based on the ECG.
• The medical history and physical examination results must be taken into consideration during the decision-making process.
• The software is intended for use in a quiet environment on patients with an audible heart sound and a clear, noise free ECG tracing.
• The software should not be used on patients where the physician has difficulty to auscultate with an electronic stethoscope, obese patients and patients with pulmonary noise.
• The ECG classifier has only been evaluated for the detection of AFib or normal sinus rhythm and is not intended to detect any other type of arrhythmia. It cannot detect heart attacks.
• The murmur classifier only informs the clinician about the presence or absence of murmurs in the phonocardiogram. It does not attempt to classify murmurs as innocent or pathologic. The physician should conduct a more complete analysis of the detected murmur to determine whether it is innocent or pathologic.
• The Bradycardia detection indicates that atrial fibrillation is not detected and the heart rate is less than 50 beats per minute, which is slower than normal for most people. Please note, less than 50 beats per minute can be normal for healthy adults, athletes, and during sleep.
• The Eko Analysis Software derives QRS duration from a single-channel ECG tracing and may underestimate the actual QRS duration.
• Notifications made by this feature are potential findings, not a complete diagnosis of cardiac conditions. All notifications should be reviewed by a medical professional for clinical decision- making.
• The Eko Analysis Software may be unable to return a result if the CORE / DUO device is unable to connect to the mobile device over Bluetooth or if the mobile device is unable to connect to the internet.
• Final judgment on the diagnosis still lies with the qualified medical personnel.

The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients’ heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate and QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias.
It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years).

Notices

This manual provides instructions for the use of the Eko Analysis Software. It is assumed that the user is familiar with basic application use 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 Analysis Software. The quality of the ECG is dependent on proper preparation practices including, but not limited to, body hair, skin dryness, and clean contact area.
It is highly recommended that users of the mobile App and web Dashboard use device and networking security features to protect patient data created and stored using this software, in addition to security features embedded in the system.
The Eko Analysis Software requires a minimum internet connection speed. The recommended upload speed for the mobile app is 4000 Kbps. 4G cellular data service or similar is recommended.

MURMUR DETECTION

• The murmur detection analysis identifies possible murmurs in a heart sound recording. It is not a diagnosis, it is only a potential finding. You should conduct further evaluation if a murmur is detected. It will not detect cardiac conditions that do not cause heart murmurs. A murmur finding is often a recommendation for echocardiography or specialist referral.
• Proper handling of the stethoscope to minimize external background noise and hand rub/clicks should be practiced. All heart sound positions should be analyzed before making a referral decision.
• This software cannot analyze lung sounds.
• This device has not been tested on a pediatric population and is not recommended for use on children. The murmur classifier only informs the clinician about the presence or absence of murmurs in the phonocardiogram of adults. It does not attempt to classify murmurs as innocent or pathologic.
• Children commonly have innocent murmurs, e.g. Still’s Murmur. Innocent murmurs are common during infancy and childhood and often disappear by adulthood. These are sometimes known as
  “functional” or “physiologic” murmurs. Please refer to recommended clinical guidelines to determine appropriate actions for innocent and pathologic murmurs.

The possible results are:

• No Murmur Detected
• Murmur Detected in Heart Sounds
• Poor quality heart sounds.

ATRIAL FIBRILLATION AND SINUS RHYTHM

The Atrial Fibrillation (AF) analysis detects atrial fibrillation in an ECG tracing. After you have recorded an ECG, if atrial fibrillation is detected you will be notified within the app. This finding is not a diagnosis, it is only a potential finding. You should conduct further diagnosis if AF is found. The AF analysis detects atrial fibrillation (AF) only. It will not detect other potentially life threatening arrhythmias, and it is possible that other cardiac arrhythmias may be present. The AF detector only detects AF during a recording. If an ECG is neither AF nor sinus rhythm, the analysis will return “unclassified.”

The possible results are:

• Normal Sinus ECG Rhythm
• Possible Atrial Fibrillation
• Unclassified ECG
• Poor quality ECG

If poor quality ECG is detected, try to improve the ECG quality (e.g. by adding gel to the electrodes and by ensuring good and stable skin contact).
If poor quality ECG or unclassified ECG is continued to be found, consider an alternative diagnosis method for rhythm diagnosis.

BRADYCARDIA AND TACHYCARDIA
The Bradycardia and Tachycardia analysis provides alerts for low and high heart rates in the ECG or heart sounds.

• Bradycardia is defined as a heart rate below 50 BPM.
• Tachycardia is defined as a heart rate above 100 BPM.

ANALYSIS USAGE
Note that the analysis software has been trained and tested on a limited number of ECG vectors. Not every ECG vector will produce high accuracy. A high quality ECG and heart sound signal must be present for an analysis to be run successfully.

SIGNAL QUALITY ANALYSIS
If a recording has poor ECG or heart sound signal, the interpretation will return with a result of poor quality ECG or heart sounds and will not analyze the recording.

Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 USA www.ekohealth.com
0537
Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands
© 2020 Eko Devices, 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. LBL046 Rev D –
Issue Date: March 2022

References

• Eko Digital Stethoscopes, AI Disease Detection, & Telehealth
• Patents – Eko Help Center
• Eko Digital Stethoscopes, AI Disease Detection, & Telehealth

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