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2.2 Precautions
• The device is intended to be used by or under the supervision of licensed medical professionals. The device may be used on patients during
a physical assessment in a clinical setting or by patients under the supervision of a clinician. The system provides one source of data that is
significant only when used in conjunction with clinician oversight and consideration of other relevant patient information. The ECG displayed on
the device screen is a tool to assist clinical decisions and is not a diagnosis.
• CORE 500™ should be used only by qualified clinicians or by patients with an adequate understanding of the device. CORE 500™ is intended for
use on patients that can be auscultated normally with an acoustic stethoscope.
• This manual provides instructions for the use of CORE 500™ and the Eko App. It’s assumed that the user is familiar with basic mobile application
use on iOS™ and Android devices.
• Standard procedures for auscultation should be followed, including background noise reduction and optimal patient positioning. Use the
provided earpiece with the CORE 500™ for best audio quality. The quality of organ sounds is dependent on proper use, including holding the
device still and increasing volume as needed.
• The quality of the ECG is dependent on proper preparation practices including, but not limited to, cleaning the contact area, electrodes and
using ECG gel. If used on a portion of the body with significant body fat, body hair, or very dry skin, a successful recording may not be possible.
• The device is not intended for diagnostic purposes. The device uses dry electrodes and is not recommended to determine the absolute
amplitude of the ECG signal. Eko recommends that the device display and the mobile app be primarily used for ensuring good ECG signal
quality and rhythm analysis.
• The device can be used with any wired headphones or wired headsets. No performance guarantees are claimed using other audio products. If
using other headphones, insertable earbuds provide the best sound quality. The device can also be used with wireless listening devices, such as
hearing aids, connected through the mobile app. For optimal audio quality while using the mobile app, it’s not recommended to listen through
the mobile device’s in-built speaker.
• Please read, understand, and follow all safety information contained in these instructions prior to using the CORE 500™. It’s recommended that
these instructions be retained for future reference.
• No modification of this equipment is allowed. There are no repairable parts inside the CORE 500™.
• This device does not detect or measure all heart rate, heart rhythm, and heart waveform changes. The heart rate algorithm has not been
validated for patients under the age of 1.
• Electromagnetic disturbance may aect the heart rate accuracy of the CORE 500™ Digital Stethoscope.
• DO NOT use the device while it is charging.
• To reduce the risks associated with infection, follow all cleaning instructions included in this manual. Establish and follow a cleaning schedule
after each use.
• DO NOT use the device over broken skin or wound areas.
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