Research Article International Journal of Cardiology Research & Reviews Accuracy of the WBP-02A Device for Ambulatory Blood Pressure Measurement According to the Universal Protocol Claudio Fania1*, Elena Meggiolaro1, Debora De Franceschi1 and Paolo Palatini2 Poliambulatorio Arcella, Padova, Italy. Studium Patavinum, University of Padova, Padova, Italy. Correspondence Dr. Claudio Fania Poliambulatorio Arcella, Via Tiziano Aspetti, 106 - 35133 Padova, Italy. Received Date: 04 June 2025 Revised Date: 20 June 2025 Accepted Date: 08 July 2025 Publication Date: 15 July 2025 Methods: The WBP-02A device was tested in 95 subjects from the general population using four cuffs of different size and in 36 subjects who underwent a bicycle ergometric test. Copyright © 2025 CME Online Library. This is an open- access article distributed under the terms of the Creative Commons Attribution 4.0 International license. Objective: To determine the accuracy of the Hingmed WBP-02A monitor, an ambulatory blood pressure monitoring device, according to the new ISO81060-2 2018/Amd 1/Amd 2 (Universal) protocol. Results: In the general population, the mean device–observer blood pressure difference was 3.98±3.77 mmHg for systolic blood pressure and 3.53±3.37 mmHg for diastolic blood pressure. The mean and standard deviation were below the maximum values required by the protocol (≤ 5 ± 8 mmHg) and thus criterion 1 was satisfied. Also criterion 2 of the protocol was satisfied being the standard deviations (3.71/3.31 mmHg) well below those required by the protocol (5.64/5.97 mmHg). During the ergometric test the mean device–observer difference was 3.84±2.97 mmHg for systolic blood pressure and 3.30±3.06 mmHg for diastolic blood pressure satisfying the protocol requirement. Conclusions: The WBP-02A monitor satisfied the ISO 81060-2:2018/Amd 1/Amd 2 standard requirements for a general population study and also the protocol criterion for ambulatory blood pressure monitoring devices. Keywords Ambulatory Blood Pressure Monitoring (ABPM), WBP-02A device, Hypertension. The accuracy of blood pressure (BP) measurement is of paramount importance for the correct diagnosis of hypertension and the choice of appropriate antihypertensive treatment. To this end a well standardized procedure should be followed using reliable BP measurement devices [1,2]. Thus, as recommended by all international guidelines, only automatic BP monitors validated according to the requirements of international protocols should be used. With the old validation protocols, arm size was not included among the patient selection criteria [3-5]. In addition, the requirements for devices intended for ambulatory BP monitoring were the same as those for office or home BP monitors and the validation test was performed only in a stationary condition. The recent ISO protocol 81060-2:2018/ Amd1/Amd 2 (ISO), which represents the joint action of the Association for the Advancement of Medical Instrumentation, European Society of Hypertension International Protocol and International Organization for Standardization [6,7], established more stringent criteria for the validation of BP measuring devices Int J Cardiol Res Rev. 2025; Vol 2, Issue 1 Open Access including arm size distribution among the criteria for subject recruitment to ensure an even representation of all cuffs [8]. In addition, for the validation of monitors intended for ambulatory BP measurement (ABPM) an additional clinical investigation was required. In fact, the accuracy of the monitor has to be tested also during exercise on a bicycle ergometer to obtain an increase in heart rate of at least 15% of baseline level [8]. The aim of this study was to verify the accuracy and reliability of the WBP-02A device, intended for ABPM. The WBP-02A was first validated in a general population study and then tested in a subgroup of participants who performed bicycle ergometry. SUBJECTS AND METHODS Participants Participants older than 12 years of age were recruited from among the outpatients or the staff of the Poliambulatorio Arcella, Padua, Italy. Gender and BP distributions for the WBP-02A general population and ambulatory BP studies Citation: Fania C, Meggiolaro E, De Franceschi D, et al. Accuracy of the WBP-02A Device for Ambulatory Blood Pressure Measurement According to the Universal Protocol. Int J Cardiol Res Rev. 2025;2(1):1-4. DOI: 10.52106/3066-3431.1010. Pa

Claudio Fania, et al. Int J Cardiol Res Rev. 2025; 2(1) are reported in table 1 and 2, respectively. The distribution of upper arm circumference was in accordance with the ISO requirements for a device provided with 4 cuffs (Table 3). The study was approved by the Institutional Review Board of the Poliambulatorio Arcella and performed according to the Declaration of Helsinki. A written informed consent was given by all the participants. Range of blood pressure in mmHg at least 5% at least 20% at least 5% at least 5% at least 20% at least 5% Table 1: Characteristics of the participants enrolled...

Claudio Fania, et al. Int J Cardiol Res Rev. 2025; 2(1) RESULTS General Population Study Ninety-five participants were enrolled to satisfy the minimum number of subjects per cuff and were categorized on the basis of the BP and arm size ranges (Table 1). The participants’ arm size distribution, BP range and cuff type are reported in table 3. All participants’ characteristics satisfied the requirements of the ISO protocol. In the general population, the mean device–observer difference in the 285 separate BP data pairs was 3.98±3.77 mmHg for systolic BP and 3.53±3.37 mmHg for diastolic BP in agreement...

Claudio Fania, et al. Int J Cardiol Res Rev. 2025; 2(1) Figure 3: Scatter plots of systolic and diastolic blood pressure differences between the WBP-02A device and the observers (y-axis) against the average of the test device and observer pressure values (x-axis) during the ergometric test in the Ambulatory BP Monitoring study (N=36). DISCUSSION Before 2018, for the validation of ABPM devices all international protocols used the same criteria as those used for devices measuring BP in resting conditions [3-5]. However, during ABPM BP is measured with the subject performing his/her routine activities...