Clinical evaluation of the oscillometric blood pressure monitor in adults and children based on the 1992 AAMI SP-10 standards.
OBJECTIVE
A noninvasive blood pressure monitor (model BP8800MS, Colin Medical Instruments Corp., San Antonio, TX) that uses the oscillometric principle was evaluated against the manual auscultatory method in 85 adults and 85 children following the requirements of the 1992 AAMI SP-10 standard. This was the first evaluation study of the electronic sphygmomanometers according to the new AAMI standards.


RESULTS
In adult subjects, the mean difference and standard deviation of the differences between the oscillometric and auscultatory methods were 2.81 +/- 5.35 mm Hg (mean +/- SD) for systolic and 0.04 +/- 4.90 mm Hg for diastolic; in children, they were 3.18 +/- 5.96 mm Hg for systolic and -0.82 +/- 5.24 mm Hg for diastolic. Excellent correlation between the oscillometric and auscultatory methods, particularly the diastolic pressure, is due to usage of the Phase V Korotkoff's sounds for auscultatory detection of the diastolic pressure, increased accuracy of the two observers' measurements, and proper selection of cuff sizes depending on the mid-arm circumference. Five different-sized cuffs were used in this study. The cuff-width-to-midarm circumference ratio was adjusted to be 0.4 or larger to minimize the measurement error associated with mismatch of cuff-size/arm-size relationship. The distribution of errors associated with each cuff was nearly the same.


CONCLUSIONS
The 1992 AAMI SP-10 standards offer a thorough evaluation of the oscillometric sphygmomanometer by enforcing more stringent criteria on (1) agreement between two observers, (2) wide spectrum of blood pressure from hypertensive (above 180 mm Hg) to hypotensive, and (3) data analysis. The oscillometric blood pressure monitor evaluated in this study meets the specifications of the new AAMI SP-10 standards and can offer an accurate, automatic, and noninvasive measure of both systolic and diastolic blood pressure in adults and children. It can safely replace the manual or automatic auscultatory system in various clinical settings.
Ling
J
J
Department of Surgery, Baylor College of Medicine, Houston, TX 77030, USA.
Ohara
Y
Y
Orime
Y
Y
Noon
G P
GP
Takatani
S
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D001795:Blood Pressure Determination / Q000295:instrumentation*; D015924:Blood Pressure Monitors / Q000592:standards; D002648:Child; D002675:Child, Preschool; D004560:Electricity; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D006801:Humans; D007223:Infant; D008875:Middle Aged; D015588:Observer Variation; D009991:Oscillometry