CORE 500™ FAQ

Product overview

What is it?

What is the value of ECG in a stethoscope?

Is the CORE 500™ analog or digital?

Why does it have a unique shape?

What does each icon on the screen mean?

How durable is the CORE 500™?

 

Use cases

How is it useful in primary care settings?

Who is the CORE 500™ for?

Can I use it for pediatrics?

Does it work with a pacemaker?

Can students use it?

Can I use it on animals?

 

Audio

Does it come with the earpiece?

Can it be used without the earpiece?

Can it be used with headphones or hearing aids?

How does it work for Bluetooth or wireless listening?

What is TrueSound™?

What are the audio filters and how do they work?

 

Battery and charging

How long will the battery last before needing a charge?

Can I use the CORE 500™ if the battery is dead?

Is the battery rechargeable?

Does it have a sleep mode to conserve battery?

 

Cleaning and care

Is it waterproof? How do I clean or sanitize it?

The bottom of the diaphragm is collecting dust. How do I clean it?

 

Device comparisons

What’s the difference between the CORE 500™ and the 3M™ Littmann® CORE Digital Stethoscope?

What’s the difference between the CORE 500™ and the DUO™?

Is the CORE 500™ better than the DUO™?

Does the CORE 500™ have better sound quality than the 3M™ Littmann® CORE Digital Stethoscope or CORE™ attachment?

 

Software and Eko App

Can I get rid of this screen that tells me to connect to the Eko App?

Do I have to use the Eko App with the CORE 500™?

How does the CORE 500™ work with the Eko App?

Is the CORE 500™ compatible with Eko software?

How do I take recordings with the CORE 500™?

Where can I see recordings I have taken?

What is Eko AI-powered analysis or automated detection?

How does Eko Automated Heart Disease Detection or AI-analysis work with the CORE 500™?

 

Returns and warranty

What is the warranty and return policy?

 

Regulatory

Is the CORE 500™ FDA cleared?

Can I buy the CORE 500™ in my country?

 

Product overview

What is the CORE 500™ Digital Stethoscope?

The CORE 500™ is the first digital stethoscope on the market with high-definition audio, a full-color display with disease indication, and 3-lead ECG. Supported by Eko's FDA-cleared AI, the stethoscope flags abnormalities such as AFib in seconds, right at the point of care.

With advanced audio features such as amplification, noise cancellation, and fine-tuned filters, the CORE 500™ offers the ultimate audio experience for improved detection and confident clinical decision making.

What is the value of ECG in a stethoscope?

A digital stethoscope with ECG provides insight into a patient’s heart rhythm quickly and easily. This data builds toward a more complete assessment, giving a clinician more insight into their patient’s cardiac health.

Using a stethoscope to capture ECG data provides access to heart rhythm data when a more advanced ECG is unavailable‌. It’s also a time- and cost-effective alternative to a more advanced ECG and can provide more information before ordering a full ECG exam.

Is the CORE 500™ analog or digital?

The CORE 500™ is only a digital stethoscope and does not have an analog mode.

Why does the CORE 500™ have a unique shape?

The CORE 500™ chestpiece incorporates a stethoscope diaphragm and 3 ECG electrodes to support heart and lung assessments. Our engineering team evaluated an array of 3D designs and ultimately selected a form factor that resembles a standard stethoscope while supporting ECG exams. The CORE 500™’s shape is lightweight, ergonomic, and easy to use day after day.

What does each icon on the CORE 500™ screen mean?

See CORE 500™ screen descriptions.

How durable is the CORE 500™?

During the development process, we conducted extensive testing to validate the durability of the CORE 500™. The device is IP44 rated, meaning it can withstand exposure to dust and splashing water. The device display is shatter resistant, withstanding 1.25lbs dropped from 30 inches above the device. It also withstood drop testing from a height of 1.5 meters. The device is able to sustain shocks of up to 30g of acceleration and random vibration.

Use cases

How is the CORE 500™ useful in primary care settings?

The CORE 500™ Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).

The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

The CORE 500™ is useful in primary care settings as it allows clinicians to hear body sounds more clearly, measure heart rate, see heart rhythm via ECG, and flag the presence of an AFib in seconds. It can help clinicians gain more confidence with their assessments. A report with the recording can be easily shared with specialists or other clinicians. 

Using the CORE 500™ to capture ECG data provides access to heart rhythm data when a more advanced ECG is unavailable. It’s also a time-and cost-effective alternative to a more advanced ECG and can provide more information before ordering a full ECG exam.

The CORE 500™ can also serve as a teaching tool for patients. The digital display allows them to see their heart rhythm and better understand their treatment plan.

Who is the CORE 500™ for?

The CORE 500™ is a high-performance stethoscope with 3-lead ECG, designed for any clinician who needs to listen to heart and lung sounds with precision, works in settings with background noise, or regularly assesses patients for arrhythmias such as AFib. The device can be used in screening, monitoring, or triaging patients in both outpatient and inpatient settings.

Recommended for:

  • Physicians

  • PAs and NPs

  • Nurses

  • EMTs and first-responders

  • Respiratory therapists

  • Home health providers

Can I use the CORE 500™ and software for pediatrics?

The CORE 500™ Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).

The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

The CORE 500™ and the Eko App are cleared for use on pediatric and adult patients. Arrhythmia detection, supported by Eko AI, are cleared for use on adults 18 years and older.

Does the CORE 500™ work with a pacemaker?

The CORE 500™ can be used safely on patients with pacemakers. However, it is not capable of recording the ECG activity of an implanted pacemaker. Refer to the CORE 500™ Instructions for Use (IFU) for cautions and warnings.

Can students use the CORE 500™?

Yes, we encourage students to use Eko stethoscope technology to learn auscultation skills and how to identify heart, lung, and body sounds.

Can I use the CORE 500™ on animals?

While the CORE 500™’s clinical performance and safety is cleared for human patients, it can also be safely used on animals under the use of veterinarian professionals for animal auscultation and ECG readings. The ECG has limited functionality on animals as it can be difficult to get a signal through fur. The stethoscope and amplification should work as expected.

Note

Automated AFib detection (supported by Eko AI) is not intended to be used on animals.

Tips for ECG readings for animals:

  • Wet the fur with water.

  • Use ECG gel if wetting the fur doesn't help.

  • Always use the CORE 500™ on the least hairy spots. Under the armpits usually works.

  • Shave the hair in the area where you'll be placing the CORE 500™.

Audio

Does the CORE 500™ come with the earpiece?

The CORE 500™ includes an earpiece that can be securely attached to the chestpiece with a locking mechanism. The earpiece has been designed with in-ear speakers to provide clear, low frequency reproduction of body sounds. Silicone ear tips and optimized acoustic design provide increased noise reduction and enhanced sound quality.

See CORE 500™ earpiece.

Can the CORE 500™ be used without the earpiece?

You can use the CORE 500™ with or without the included earpiece. However, we recommend using the provided earpiece for the best audio quality, as we can’t guarantee performance with other audio products.

The CORE 500™ has a 3.5mm audio jack that can be used with either the included earpiece or any wired audio device with a standard 3.5mm plug. If using other headphones, insertable earbuds provide the best sound quality.

The CORE 500™ can also be used with wireless listening devices, such as hearing aids or Bluetooth headphones, connected through the Eko App. For best audio quality while using the Eko App, it’s not recommended to listen through the mobile device’s in-built speaker.

Can the CORE 500™ be used with headphones or hearing aids?

The CORE 500™ can be used with wireless listening devices, such as hearing aids or Bluetooth headphones, connected through the Eko App. For best audio quality while using the Eko App, it’s not recommended to listen through the mobile device’s in-built speaker.

See Set up wireless listening.

How does the CORE 500™ work for Bluetooth or wireless listening?

The CORE 500™ provides wireless functionality using Bluetooth technology when using the Eko App for iOS and Android. The app pairs with Bluetooth-enabled headphones, hearing aids, and speakers. Note that the CORE 500™ itself doesn’t pair directly with wireless listening devices. The pairing is through the Eko App.

See Set up wireless listening.

What is TrueSound™?

TrueSound™ is Eko’s newest audio innovation. By integrating in-ear speakers into the earbuds of the CORE 500™, the digital stethoscope can transmit the clearest, most precise sound during every physical exam.

TrueSound™ provides optimal sound filtering, background noise reduction, and minimized artifact, helping clinicians hear even the softest heart and lung sounds when auscultating.

What are the audio filters and how do they work?

The CORE 500™ has 3 audio filters that have been optimized for the unique frequency of body sounds:

  • Cardiac for heart sounds.

  • Pulmonary for lung sounds.

  • Wideband for all body sounds.

The audio filters pass specific frequency ranges of the signal and reduce frequencies that could be distracting. This provides a clearer listening experience.

See CORE 500™ audio filters.

Battery and charging

How long will the CORE 500™’s battery last before needing a charge?

The CORE 500™ is expected to last up to 60 hours of regular clinical use on a single charge.

The CORE 500™’s observed battery life length from one full charge was 60 hours of use on average (median: 64 hours). Clinicians reported being able to see an average of 92 patients with the CORE 500™ on one full charge.

See CORE 500™ battery and charging.

Can I use the CORE 500™ if the battery is dead?

No, the CORE 500™ is only a digital stethoscope and requires battery power. The battery is easy to recharge with the provided USB-C cable. The battery will charge from 0% to 100% in 3 hours.

See CORE 500™ battery and charging.

Is the battery rechargeable?

Yes, the CORE 500™ has a rechargeable lithium-ion battery. Insert the included USB-C cable into the USB port on the CORE 500™ and plug the other end into a UL-certified USB wall charger (max 5 volts) (not included in product box). The battery will charge from 0% to 100% in 3 hours.

See CORE 500™ battery and charging.

Does the CORE 500™ have a sleep mode to conserve battery?

The CORE 500™ automatically turns off after a short period of not being used. This preserves battery life when you are not actively using the device. The CORE 500™ has a touch sensor, so it will turn back on when you pick it up around the neck of the chestpiece.

You can turn off this setting in the Eko App.

You can also turn off the device to conserve battery by holding the top button while pressing the volume up button once. Once you see the confirmation screen, press the volume-up button again to confirm.

See Turn on and turn off the CORE 500™.

Cleaning and care

Is the CORE 500™ waterproof? How do I clean or sanitize it?

The CORE 500™ is IP44 rated, meaning it can withstand exposure to dust and splashing water. The CORE 500™ can be regularly sanitized with 70% Isopropyl Alcohol (IPA) following standard cleaning protocols. However, do not immerse the device in any liquid or subject it to any high-pressure/autoclave sterilization processes.

See CORE 500™ care and cleaning.

The bottom of the diaphragm is collecting dust. How do I clean it?

We recommend using 70% Isopropyl Alcohol (IPA) to sanitize the diaphragm of the CORE 500™.

See CORE 500™ care and cleaning.

Device comparisons

What’s the difference between the CORE 500™ and the 3M™ Littmann® CORE Digital Stethoscope?

The CORE 500™ is a digital stethoscope with 3-lead ECG. The CORE 500™ is built with TrueSound™ technology, Eko’s premium audio experience. The CORE 500™ has a digital display on the device allowing a clinician to visualize heart rate and an ECG rhythm strip.

The Littmann® CORE is the highest performance stethoscope in the Littmann portfolio. The Littmann® CORE is a 3M™ Littmann® Cardiology IV™ Stethoscope that is pre-assembled with the Eko CORE™ Digital Attachment.

What’s the difference between the CORE 500™ and the DUO™?

The CORE 500™ resembles a traditional stethoscope in shape and has a 3-lead ECG. The CORE 500™ has a digital display on the device allowing a clinician to visualize the ECG waveform without taking out their mobile device.

CORE_500.jpg

The Eko DUO™ has a block form factor and a 1-lead ECG.

DUO.png

Is the CORE 500™ better than the DUO™?

The CORE 500™ offers 3-lead ECG whereas the DUO™ offers 1-lead ECG. The CORE 500™ also has a digital display on the device allowing a clinician to visualize heart rate and an ECG rhythm strip.

The CORE 500™ offers Eko’s best audio experience with up to 40x sound amplification and in-ear speakers for optimized listening.

Does the CORE 500™ have better sound quality than the 3M™ Littmann® CORE Digital Stethoscope or CORE™ attachment?

The CORE 500™ is built with TrueSound™ technology, which provides the highest sound quality of any Eko digital stethoscope.

The CORE 500™ has up to 40x sound amplification and active noise cancellation. The CORE 500™ earpiece is uniquely built with in-ear speakers to reduce background and handling noise when listening to body sounds. The CORE 500™ also offers cardiac and pulmonary filter modes that are tuned for these specific sounds.

Software and Eko App

Can I get rid of this screen that tells me to connect to the Eko App?

The Connect device to app screen disappears after you connect the device to the Eko App on a compatible mobile device. Here's how.

CORE_500_Connect_Device_to_App.png

Do I have to use the Eko App with the CORE 500™?

The CORE 500™ provides the most clinical value when connected with the Eko App. Downloading and connecting your CORE 500™ to the Eko App is required to complete setup of the device. There are specific features, including wireless listening, recording, and sharing reports, that require the Eko App. The app is also required to send heart sound data from the CORE 500™ to the app.

When the CORE 500™ is connected to the Eko App with Bluetooth, you can auscultate, take multiple recordings, and see results on the CORE 500™ screen without taking out your mobile device.

See Overview of the Eko App.

How does the CORE 500™ work with the Eko App?

The CORE 500™ connects to the Eko App via Bluetooth to provide access to the platform’s full feature set. Once the CORE 500™ is connected to the app, you can listen wirelessly, see Eko AI-powered automated detection results in detail, record sounds, and review and share recordings.

See Overview of the Eko App.

Is the CORE 500™ compatible with Eko software?

Yes, the CORE 500™ pairs with the Eko App. Download the Eko App for free in the iOS App Store or Android Google Play Store.

If you’re interested in using CORE 500™ with other Eko software, please reach out to our sales team.

How do I take recordings with the CORE 500™?

You can start a recording from the Eko App or the CORE 500™, as long as the device is connected via Bluetooth to the Eko App.

Learn how to start a recording from the Eko App or from the CORE 500™ device.

Where can I see recordings I have taken?

In the Eko App, tap the Patients button on the bottom menu to see all previous recordings. Recordings that have not been assigned to a specific patient appear under the Unassigned tab.

If you took a recording directly from the CORE 500™, it also shows under the Unassigned tab.

See Manage patients and recordings in the Eko App.

What is Eko AI-powered analysis or automated detection?

Eko Analysis Software, or Eko AI, is FDA-cleared software intended to provide support to the physician in the evaluation of patients’ heart sounds and ECGs. The software analyzes simultaneous ECG and heart sounds. The software 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 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).

When the Eko App is connected and used with a compatible digital stethoscope, Eko AI is used to check for signs of heart disease.

The Eko App summarizes any findings, including potential AFib or other abnormalities. These findings aren’t a diagnosis, but are intended to aid the clinician in reaching a diagnosis accurately, quickly, and confidently.

How does Eko Automated Heart Disease Detection or AI-analysis work with the CORE 500™?

When the Eko App is connected and used with the CORE 500™, Eko’s FDA-cleared software automatically checks for signs of heart disease.

Analysis results show on the CORE 500™ screen if:

  • You have the Recording Analysis setting in the Eko App turned on. Learn how here.

  • The recording is at least 15 seconds in length.

  • The CORE 500™ made skin contact for ECG-related results such as AFib.

You can also use the Eko App to review a summary of findings, such as AFib or other abnormalities. These findings aren’t a diagnosis, but are intended to aid the clinician in reaching a diagnosis accurately, quickly, and confidently. See View analysis results.

Returns and warranty

What is the warranty and return policy?

The CORE 500™ includes a 2-year warranty which is warranted against any defects in material and workmanship.

All stethoscopes purchased on the Eko website are backed by a 100% refundable, 75-day trial. We offer free returns within 75 days of receiving your stethoscope.

See the return policy and the warranty policy.

Regulatory

Is the CORE 500™ FDA cleared?

Yes, the Eko CORE 500™ Digital Stethoscope and Eko Analysis Software are cleared by the FDA for sale in the United States.

See Regulatory.

Can I buy the CORE 500™ in my country?

The CORE 500™ is FDA cleared in the United States and is for sale in the US only at this time. The CORE 500™ can only connect to the U.S. version of the Eko App, in the U.S. Apple App Store or Google Play Store.

 

 

LBL:

0002143 Rev.5.0

Date of Issue:

August 29, 2023

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