Design, Setting, Participants
- The article details the exacting, multiphase certification procedure. The most demanding step requires the recruitment of eighty-five individuals with BP ranging from <90 to >180 mm Hg systolic and <60 to >110 mm Hg diastolic. A participant's BP is taken with the test device and then in the same arm with 2 mercury sphygmomanometers. The mercury units are connected in series allowing for the 2 measurements to be executed simultaneously.
- A minimum of 3 paired readings (test vs mercury unit 1 or 2) per participant are recorded generating 255 pairs of values.
- Measurements begin after 5 minutes' rest with 30-60 seconds between readings.
- The accuracy of the submitted model is graded as follows: An "A" rating is awarded if the difference in BP between the test and a mercury apparatus is
5 mm Hg at least sixty percent of the time,
10 mm Hg eighty-five percent of the time, and
15 mm Hg ninety-five percent of the time. Grades of "B" and lower are assigned to models with lesser degrees of accuracy. Devices designated "A" for systolic and diastolic values are preferred.
- Omron sponsored the study; the authors declare no conflicts of interest.