Smartphone application-supported validation of three automatic devices for self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7120, Yuwell YE680A and Cofoe KF-65B

Abstract

Background Accurate measurement of blood pressure (BP) is crucial to hypertension control and prevention of future stroke and heart attack. All BP measuring devices must be validated independently in the clinical setting. Objective To validate the accuracy of three automatic upper arm devices (Omron HEM-7120, Yuwell YE680A and Cofoe KF-65B) for self-measurement of BP in Chinese adults with arm size of 22–32 cm. Methods The validation was conducted independently for each of the three devices according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010), with the facilitation of a designated smartphone application. Subjects were recruited from those attending Beijing Anzhen Hospital for routine physical examination and clinic visits. For each device, BP was measured sequentially in 33 adults using a mercury sphygmomanometer (two observers) and the test device (one supervisor) with seven measurements alternating between observers and the device, which generated a total of 99 before/after paired values for SBP and DBP separately. The judgments were made based on the distribution of the paired difference among the 99 measurements (Part 1) and among the 33 subjects (Part 2). To pass, a device must achieve all the minimum Pass requirements in Part 1 and Part 2 for both SBP and DBP (Part 3). Results Only HEM-7120 achieved the part 1 and part 2 targets for both SBP and DBP. KF-65B achieved the DBP targets of part 1 and part 2 but failed for SBP. YE680A only achieved the DBP targets of part 2 but failed for all others. The findings also indicated that the devices had higher SBP readings (1.3 mmHg, 1.0 mmHg and 4.1 mmHg higher for HEM-7120, YE680A and KF-65B, respectively) and lower DBP readings (2.0 mmHg, 1.1 mmHg and 3.3 mmHg lower, respectively) when compared to the mercury sphygmomanometer. Conclusions The Omron HEM-7120 passed the requirements of the ESH-IP 2010 revision, while the Yuwell YE680A and Cofoe KF-65B failed (part 3).

Validations of Blood Pressure Measuring Devices Using Recognized Protocols

“…We found positive results in most studies, exceeding the protocol in question and validating the test devices for their recommended use, as well as in the population analyzed, with the exception of two studies with four test devices, Omron RS6 (hem-6221-E), Microlife WatchBP O3 [ 33 ], Yuwell YE680a, and Cofoe KF-65B [ 67 ].…”

“…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 ].…”