Validation of an Automatic Sphygmomanometer with “360°” Cuff 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. Sphygmomanometer “Armed” identical to previously validated in the general population group YuWell YE660E was used with a “360°” cuff designed for an upper arm circumference of 18 – 36 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 8.00 ± 6.30 / -16.11 ± 5.15 mmHg. In this special group “Armed” YE660E with “360°” cuff do not meet the requirements of ISO 81060-2:2018.