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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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