Validation of the Omron HBP-1320 for professional use according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the 2010 revision of the European Society of Hypertension International Protocol

Abstract

Objective Performance of the Omron HBP-1320, designed for professional use by adding several features to the home blood pressure (BP) measuring device, was validated using two different protocols, specifically the ANSI/AAMI/ISO 81060-2:2013 (ANSI/AAMI/ISO) and the European Society of Hypertension International Protocol, 2010 Revision (ESH IP2), as a separate study. Methods Three trained medical technologists validated the performance of this device by comparing data obtained from the device with those obtained using a standard mercury sphygmomanometer throughout the study. Results Mean differences in mercury readings for systolic BP (SBP) and diastolic BP (DBP) between the devices were 1.6 ± 5.8 and −0.4 ± 5.3 mmHg, respectively, according to the ANSI/AAMI/ISO protocol, and mean device-observer measurement differences were −0.4 ± 4.9 and −0.2 ± 4.2 mmHg, respectively, satisfying Part 1 of ESH IP2. Differences in SBP and DBP both satisfied Part 2 of ESH IP2. The number of absolute differences in the values obtained using the device and those obtained by the observers fulfilled the requirements of the ANSI/AAMI/ISO protocol and ESH IP2. Conclusion Omron HBP-1320 met all requirements of the ANSI/AAMI/ISO protocol and ESH IP2.

Validations of Blood Pressure Measuring Devices Using Recognized Protocols

“…Of the above, many are recommended devices for HBPM but some are designed for ABPM [ 32 , 36 , 46 , 48 , 53 ], while there are few validated sphygmomanometers that are used only in a professional manner [ 58 , 59 , 65 , 66 ]. According to the ESH protocol, the validation of ABPM devices is performed only in static conditions and does not require testing in ambulatory conditions.…”

“…As for the parameters assessed in the populations, all studies include recruitment SBP and DBP, age (in years), and circumference of the upper arm [ 32 , 34 , 36 , 37 , 39 , 40 , 41 , 42 , 43 , 45 , 46 , 47 , 48 , 49 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 62 , 63 , 64 , 65 , 66 , 67 ], wrist [ 38 , 40 ], or both [ 25 , 33 , 44 , 61 ] (in mm), depending on the device to be tested. Only one study does not measure any circumference of its participants [ 68 ].…”

“…As for the validation team, it also follows the rules of the protocols [ 27 , 29 ], reflected in Table 1 , so it usually corresponds to two observers and a supervisor, except for others that have additional explanations, such as teams formed by three licensed physicians [ 32 , 48 , 58 ], three nurses [ 47 , 55 ], four physicians [ 49 ], or three medical technologists [ 50 , 59 ]. All teams were trained in BP measurement.…”

“…Although the universal standard is considered the protocol of the century [ 29 ], only seven articles have been seen to follow it [ 56 , 58 , 59 , 62 , 65 , 66 , 68 ] compared to the large number of studies that follow the ESH [ 27 ], almost all of them with positive results [ 72 , 73 ], because although they share conditions, it is less strict ( Table 1 ).…”

Association of Birthweight with Overweight, Obesity, and Blood Pressure among Adolescents

“…After a rest period of at least 10 min, the participants’ BP was measured using an electronic sphygmomanometer (HBP-1320; Omron Healthcare, China) that had previously passed validation protocols [ 25 ]. Trained physicians asked the participants to assume a sitting position and chose cuffs that were appropriately sized for the participants’ right arms.…”