Blood Pressure Clinical Trial
Official title:
Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO
The purpose of this trial is to determine the accuracy of the Blood Pressure (BP) measurement of multifunction KEITO devices under test requirements of the Standard American National Standards Institute(ANSI)/Association for the Advancement of Medical Instrumentation(AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO 81060-2:2009.
Nowadays is important controlling our basic health parameters. Due this, the multifunction
KEITO Devices was designed to offer to the general public a convenient way to do so easily
in the public sites.
One of the most important parameter is the Blood Pressure (BP)measurement. To warrant their
efficacity and accuracy, was essential to perform this trial to ensure that the measurements
obtained meet with the requirements of the specific U.S. standard about Non-invasive
sphygmomanometers.
By Validating with auscultatory reference sphygmomanometer, as defined on the ANSI/AAMI/ISO
81060-2:2009 , we have been intending to demonstrate that the multifunction KEITO devices,
particularly about the Blood Pressure (BP) Measurement, have the same efficacy and accuracy
as the conventional auscultatory sphygmomanometers.
To include most of the groups of Blood Pressure (BP) measurements types on this clinical
trial, a great variety of BP ranges have been selected, always in accordance with the
standard.
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Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
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