Validation of an Automatic Sphygmomanometer with Cuff Range of “17-22” for Measurements in Adults with Upper Arm Circumference of 22 Centimeters or Less

To validate a blood pressure (BP) monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) in a special population of adults with an upper arm circumference of 22 cm or less 37 subjects were recruited. The previously validated in general population OMRON M2 Basic (HEM-7121) was used with a HEM CS24 cuff designed for an upper arm circumference of 17–22 cm. Sequential measurements of BP were obtained using the test device and the standard mercury sphygmomanometer. A total of 108 sets of comparison data were obtained and analyzed. According to the validation criterion 1, the mean ± SD of the differences was -7.81 ± 5.20 / -10.66 ± 5.48 mmHg. In this special group HEM-7121 and HEM CS24 do not meet the requirements of ISO 81060-2:2018.