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• These specifications are subject to change without notice.
• This monitor is clinically investigated according to the requirements of ISO 81060-
2:2013 and complies with ISO 81060-2:2013 and ISO 81060-2:2018+A1:2020. In
the clinical validation study, K5 was used on 85 subjects for determination of
diastolic blood pressure.
• This monitor has not been validated for use on pregnant patients.
• IP classification is degrees of protection provided by enclosures in accordance
with IEC 60529. This monitor and optional AC adapter are protected against solid
foreign objects of 0.5 inch (12.5 mm) diameter and greater such as a finger. The
optional AC adapter is protected against vertically falling water drops which may
cause issues during a normal operation.
• Operation mode classification complies with IEC 60601-1.
• Please report to the manufacturer and the regulatory authority in which you are
established about any serious incident that has occurred in relation to this device.
About a wireless communication interference
The Bluetooth option in the product is used to connect to dedicated apps
on mobile devices to synchronize date/time data from mobile device to
the product, and to synchronize measurement data from the product to
mobile device. Further handling of the data on the mobile device is up to
the user's discretion. This product operates in an unlicensed ISM band at
2.4 GHz where any third party can intercept the radio waves, willfully or
accidentally, for any unknown purpose. In the event this product is used
near other wireless devices such as microwave and wireless LAN, which
operate on the same frequency band as this product, there is a possibility
that interference may occur. If interference occurs, stop the operation of
the other devices or relocate this product away from other wireless
devices before attempting to use it.
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