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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.
Pictogram on the Product
Types of marks used to indicate the correct positioning
of the artery for the upper arm
Identifies the type of cuff that is compatible with the
blood pressure monitor
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