Clinical Study About Blood Pressure Measurement Efficacy on Multifunction Keito
The purpose of this trial is to determine the accuracy of the BP measurement of multifunction Keito devices under test requirements of the Standard ANSI/AAMI/ISO 81060-2:2009.
The Focus of Study is to Determine Efficiency and Accuracy of the Multifunction Keito Under the ANSI/AAMI/ISO 81060-2:2009.
|Official Title:||Clinical Study About Blood Pressure Measurement Efficacy on Multifunction Keito|
- Operator measurements using the Same Arm sequential method as indicated on [22.214.171.124] of the Standard applied. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]Each patient has to be measured by the reference auscultatory sphygmomanometer three times by the two different observers using a double stethoscope. The observers have accorded to use the K5 korotkoff Sound. Between each measurement, the patient has been relaxed at least 60 sec.
- Multifunction Keito BP measurement.[126.96.36.199] of the standard applied [ Time Frame: Two Weeks. ] [ Designated as safety issue: No ]The patient has been measured three times by the device under test. Between each measurement, the patient has been relaxed at least 60 sec.
|Study Start Date:||March 2011|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Wrist Size <= 14,25 cm
Population with wrist circumference which lies within the lower quarter of the specified range of use of the cuff.
Wrist Size <=16,4 Cm
Population with wrist circumference which lies within the lower Half of the specified range of use of the cuff.
Wrist size >=16,5 Cm
Population with wrist circumference which lies within the Upper Half of the specified range of use of the cuff.
Wrist Size >=17,75
Population with wrist circumference which lies within the Upper Quarter of the specified range of use of the cuff.
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 soeasily in the public sites.
One of the most important parameter is the BP measurement. To warrant their efficacity and accuracity, 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, particulary about the BP Measurement, have the same efficacy and accuracy as the conventional auscultatory sphygmomanometers.
To include most of the groups of BP measurements types on this clinical trial, a great variety of BP ranges have been selected, always in accordance with the standard.