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1.4 Continuous Operating Conditions
The operating range of the CORE 500™ is:
• A temperature range of + 5°C to + 45 °C.
• A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapor partial pressure greater than 50hPa.
It’s recommended to avoid exposure to extreme heat, cold, solvents, and oils. Extreme heat and cold will negatively aect the lithium ion battery in
the device and may aect battery life.
NOTE: If the device is used for a prolonged time at maximum ambient temperature it can get hot.
(*CORE 500™ had an increase in temperature up to 47°C when tested at 45°C ambient temperature)
1.5 Environmental Conditions of Transport and Storage Between Uses
The device is expected to be stored in a room with the following parameters:
• A temperature range of – 20 °C to + 5 °C.
• A temperature range of + 5 °C to + 35 °C at a relative humidity up to 90%, non-condensing.
• A temperature range of > 35 °C to 60 °C at a water vapor pressure up to 50 hPa.
1.6 System Requirements
For full functionality, the system requires users to connect their CORE 500™ with an internet-enabled smart mobile device using the Eko App. The
app supports Apple® mobile devices. Make sure your system and mobile device meets or exceeds the minimum performance specifications (refer to
Section 2.7 Technical Specification). Additional information on the most up-to-date system requirements can be found at support.ekohealth.com.
NOTICE: Some of the features of the Eko App require a minimum internet connection speed. The minimum recommended upload speed for
the mobile app is 4000 Kbps. A minimum of 4G cellular data service or similar is recommended for the app. The app can be used to visualize
waveforms and tracings without an internet connection, however an internet connection is necessary to save the data.
CORE 500™ uses Bluetooth® LE. Mobile devices used must be compatible with Bluetooth® LE.
Apple® is a registered trademark of Apple, Inc. Bluetooth® is a registered trademark of Bluetooth SIG, Inc.
1.7 Help and Assistance
For general and product-related comments, questions, or concerns, please contact Eko Health, Inc., directly. If you have any questions or concerns
about results found with the device, please consult a physician.
Serious Incident Reporting
If a serious incident has occurred in relation to the device, it should be reported to the manufacturer and the local competent authority 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 other person, the temporary or permanent serious deterioration of a patient’s,
user’s, fetus’s, or other person’s state of health, or a serious public health threat.
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