Abstract
Background
The accuracy of blood pressure (BP) measurements performed by electronic devices is crucial in clinical practice. International professional societies emphasize the need for rigorous, standardized validation of electronic BP measuring devices to ensure their accuracy and reliability.
Objective
This study evaluated the accuracy of the Withings BPM Pro2 (WPM07) upper‑arm oscillometric BP monitor in the adult general population using the ISO 81060‑2:2018/AMD 2:2024 Universal Standard.
Methods
Following the ISO same‑arm sequential measurement protocol, 89 eligible pre-selected participants underwent paired test‑device and mercury reference auscultatory measurements. Nine BP measurements were performed on each participant, four with the tested device and five with the auscultatory method. The accuracy of BP measurements was assessed based on the difference between simultaneous measurements taken by two observers and those displayed by the tested device using ISO Criterion 1 (mean and standard deviation of test–reference differences) and Criterion 2 (within‑subject variability of averaged difference values).
Results
Eighty-nine participants underwent the BP measurements protocol, data from 87 were analyzed after excluding 2 participants due to excessive BP variability. Inter‑observer agreement for reference measurements was 0.64 ± 2.14 mmHg for systolic BP (SBP) and 0.39 ± 1.98 mmHg for diastolic BP (DBP). ISO criterion 1 was met with mean test–reference differences of 1.0 ± 4.9 mmHg (SBP) and 0.6 ± 4.1 mmHg (DBP) below ISO requirements (≤ 5±8 mmHg). ISO criterion 2 was also satisfied, with within‑subject standard deviations of 3.50 mmHg (SBP) and 3.01 mmHg (DBP), well below the ISO thresholds (≤6.87/6.91 mmHg).
Conclusion
The BPM Pro2 (WPM07) fulfills the ISO 81060‑2:2018/AMD 2:2024 accuracy requirements and is suitable for reliable home BP self‑measurement in adults.
Keywords: blood pressure measurements, accuracy, validation, home blood pressure, oscillometric, brachial, Withings
Introduction
Over recent decades, several non‑mercury blood pressure (BP) measurement technologies have been developed, including aneroid devices, hybrid sphygmomanometers, and automated oscillometric monitors.1 As the use of such devices expands across clinical and home settings, ensuring their accuracy through independent, standardized validation has become essential.2,3 Such validation study to assess the accuracy of BP measurements by automatic devices is crucial both for their use by medical professionals in clinics and by patients for home blood pressure monitoring (HBPM). These studies must be conducted before the devices are released on the market and, most importantly, before their use is widespread among users. Multiple validation protocols have been proposed over the years; the European Society of Hypertension (ESH) International Protocol,4 the British Hypertension Society (BHS) protocol,5 and the standards from the Association for the Advancement of Medical Instrumentation (AAMI).6 Despite methodological differences, they share the collective goal of establishing harmonized procedures to determine whether devices meet predefined criteria for accuracy.
In 2018, representatives of AAMI, the ESH, and the International Organization for Standardization (ISO) collaborated to produce a unified international validation protocol.7,8 This collaboration yielded the AAMI/ESH/ISO 81060‑2:2018 Universal Standard7–9 along with its Amendment 1 (2020)10 and Amendment 2 (2024).11 This consolidated protocol is now considered the global reference for evaluating the clinical accuracy of automated, noninvasive BP monitors.8–11
The Withings BPM Pro2 (WPM07) is a CE‑marked upper‑arm oscillometric BP monitor designed for home use. Because this specific model had not previously undergone clinical validation, it was necessary to evaluate its accuracy following the most recent ISO 81060 ‑2:2018/AMD 2:2024 requirements in the general adult population.8–11 Such study is particularly important given that this device is intended for use for HBPM, which is now advised for all patients with hypertension. In fact, several studies and meta-analyses have shown that HBPM increases hypertension awareness, adherence to treatment, and BP control.12,13 Thus, HBPM is now recommended by all national and international guidelines, and all patients with hypertension should benefit from it.
The objective of this study was therefore to assess the measurement accuracy of the BPM Pro2 (WPM07) in accordance with the ISO 81060 ‑2:2018/AMD 1:2020/AMD 2:2024 Universal Standard, using all methodological elements specified for validation in the general population.8–11
Methods
Study Design
This prospective, non-interventional, non-randomized validation study evaluated the accuracy of the BPM Pro2 (WPM07), a Class IIa medical device intended for upper-arm blood pressure measurement. Ethical approval was granted by the Ethics Committee of Yerevan State Medical University after Mkhitar Heratsi (Armenia) on March 20, 2025 (decision N 8-2/25). All study procedures conformed to the ISO Universal Standard (ISO 81060-2:2018/AMD 1:2020/AMD 2:2024), the Declaration of Helsinki, International Council for Harmonization (ICH) guidelines, and Good Clinical Practice (GCP). Measurement and reporting steps adhered strictly to ISO recommendations.8–11
The ISO protocol requires predefined distributions of sex, BP levels, arm circumference categories, to ensure representative evaluation across the full operational range of the device.9–11 To achieve a passing outcome, devices must meet two independent criteria:
Criterion 1: The mean difference and standard deviation (SD) between the test device and reference measurements across all paired readings must be ≤5 ± 8 mmHg for both systolic and diastolic BP.
Criterion 2: The SD of the averaged BP differences for all subjects must remain below ISO-defined thresholds derived from the observed mean test–reference difference.8–11
Details of the ISO 81060-2:2018/AMD 1:2020/AMD 2:2024 standard have been described elsewhere.7–11
Study Population
The study population was pre-selected to ensure compliance with the ISO 81060-2:2018/AMD 2:2024 protocol’s requirements regarding age, gender, BP ranges, and arm circumference distributions.8–11
Participants were included if they had brachial circumferences between 22 cm and 42 cm, as specified in the instructions for use of the BPM Pro 2 (WPM07) device, and were either untreated or treated for hypertension. Exclusion criteria included arrhythmia, poor-quality Korotkoff sounds, implantable electric medical device, and the presence of damaged skin on the arms. Written informed consent was obtained from all participants before study enrollment.
Test Device
BPM Pro 2 (WPM07) is a CE marked digital automatic BP monitor for home BP measurement at the brachial level (Figure 1). The device measures BP during the cuff inflation using the oscillometric method with a pressure range of 0–285 mmHg (systolic: 60–230 mmHg, diastolic: 40–130 mmHg) and pulse rate range of 40–199 beats/min. The device is powered by a 3.7V/2500mAh built-in rechargeable li-polymer battery or an AC adapter powered mode: 5V-1A. The weight of the device is 548 g. It can be connected using LTE Cat M1 (Cellular), BLE, Wi-Fi wireless connections to the Withings app on a smartphone. For this study, 3 BPM Pro2 (WPM07) devices were provided, one of which was randomly selected to conduct this study and used according to the manufacturer’s instructions. The hardware version of the device used in this study is 3a (electronic) and 7 (mechanical). The firmware version of the BP algorithm is 1.0.1. The BPM Pro 2 (WPM07) uses only one cuff for arm circumferences of 22–42 cm. The entire cuff is rectangular, made of polyester and nylon for the fabric part, and its dimensions are 620 mm by 150 mm. The bladder inside the cuff is also rectangular, made of PVC, and its dimensions are 336 mm by 125 mm.
Figure 1.
The Withings BPM Pro2 (WPM07) brachial device.
Blood Pressure Measurements
The validation study was conducted by a supervisor and two observers, all of whom were trained in accurate BP measurement techniques. The observers measured BP using two parallel-connected mercury sphygmomanometers (KDM®, Germany) controlled prior to the study, and a Y-connected teaching stethoscope (3M™ Littman®, United States). Observers were blinded to each other’s measurements, and their results were cross verified by the supervisor to ensure inter-observer agreement within ±4 mmHg for both SBP and DBP; otherwise, the measurement was repeated. The BP measurement procedure was performed according to the guidelines of the European Society of Hypertension.2,14
Arm circumferences were measured to ensure appropriate cuff sizing. For the reference BP measurement (mercury), the cuff-size being used was adequate for the subject (the cuff length reached 75–100% and its width 37–50% of the arm circumference). Five sizes of cuffs were available: XS, S, M, L and XL; 3 of them have been used in the study: Small, Medium and Large, with respectively bladder dimensions of 9 x18 cm, 12 x24 cm, and 16 × 32 cm, from V-Lock® (Shenzhen China). The cuff of the test device was not used for reference BP determination. BP measurements were performed after participants rested for at least 5 min, with the left arm supported at heart level. Measurements followed the “same-arm, sequential measurements” protocol described in ISO 81060-2:2018/AMD 1:2020/AMD 2:2024.9–11
A total of nine sequential BP measurements were taken per participant: five with the reference mercury sphygmomanometers (R0, R1, R2, R3, R4) and four with the test device (T0, T1, T2, T3). Measurements were conducted at one-minute intervals, starting with the mercury sphygmomanometer. The initial readings (R0 and T0) were excluded from the analysis as recommended by the ISO protocol.7–9 The detailed procedure for measuring BP was as follows: the participant is seated comfortably with their arm resting on a table, he/she was asked not to move or speak during the BP measurement. The observers start by measuring BP with the mercury sphygmomanometer and its specific cuff, then replaced it with the tested sphygmomanometer with its own cuff; this maneuver was repeated five times with the mercury manometer and four times with the tested device. This implies that the devices and cuffs were switched eight times during the testing sequence. The cuffs were positioned according to the ESH recommendations for the reference BP measurement and according to the instructions for use for the tested device.
Statistical Analysis
Statistical analysis was performed using software developed by the International Society of Vascular Health (ISVH®).15 Each reference BP measurement was calculated as the average of the two simultaneous readings from the observers. Test device measurements were compared to the average of the preceding and subsequent reference measurements (eg, T1 was compared to the average of R1 and R2).
Differences were calculated by subtracting the reference measurements from the test device measurements. The mean and standard deviation (SD) of these differences were computed and compared to Criterion 1 of ISO 81060-2:2018/AMD 1:2020/AMD 2:2024, which specifies a mean difference of ≤5.0 mmHg and an SD of ≤8.0 mmHg. Criterion 2, addressing within-subject variation, was also evaluated.8–11
Bland-Altman scatterplots were used to illustrate the differences between the test device and reference BP measurements against their mean values. Additional Scatterplots of test-reference BP differences by subject’s limb circumference (SBP and DBP) were calculated. Population distributions by age, gender, BP values, and arm circumference were analyzed to confirm compliance with the protocol requirements.9–11
Results
Study Population
A total of 89 individuals were pre-selected at the Center of Preventive Cardiology, Hospital N2 CJSC, Yerevan. Eighty-seven participants met all protocol-specified criteria and were included in the final analysis, while two were excluded due to excessive BP variability. Table 1 details the demographic and clinical profile of the cohort, confirming full compliance with ISO 81060–2:2018/AMD 2:2024 requirements regarding age and sex distribution.9–11
Table 1.
Characteristics of the Study Participants
| N=87 | Mean ± SD | Range |
|---|---|---|
| Age (years) | 51.4 ± 14.0 | 18–84 |
| Gender (male/female) | 43/44 | – |
| Arm circumference (cm) | 32.0 ± 5.1 | 22–42 |
| Entry SBP R0 (mmHg) | 124.1 ± 19.7 | 91–170 |
| Entry DBP R0 (mmHg) | 81.6 ± 12.9 | 60–110 |
Abbreviations: DBP, diastolic blood pressure; SBP, systolic blood pressure; SD, standard deviation.
BP Measurements and Distribution
The distribution of reference blood pressure values met all ISO protocol requirements.9–11 Specifically, the following proportions were achieved:
≥5% of SBP readings ≤100 mmHg (observed: 10%) and ≥5% of DBP readings ≤60 mmHg (observed: 5.2%).
≥5% of SBP readings ≥160 mmHg (observed: 5.8%) and ≥5% of DBP readings ≥100 mmHg (observed: 12.4%).
≥20% of SBP readings ≥140 mmHg (observed: 20.7%) and ≥20% of DBP readings ≥85 mmHg (observed: 37.9%).
Inter-observer agreement for simultaneous reference measurements was excellent, with mean differences of 0.6 ± 2.1 mmHg for SBP and 0.4 ± 2.0 mmHg for DBP, within the ISO-defined acceptable range (–4 to +4 mmHg).
Arm Circumference Distribution
Table 2 shows the distribution of the arm circumferences according to the ISO 81060–2:2018/Amd.1:2020/Amd.2:2024 protocol. The results show that distributions of arm circumferences are in accordance with the protocol requirements.8–11
Table 2.
Distribution of Arm Circumference and BP Differences Results
| Arm Circumference (cm) | Minimum Participants Required n (%) | Participants n (%) | Mean SBP Difference ± SD (mmHg) | Mean DBP Difference ± SD (mmHg) |
|---|---|---|---|---|
| [22; 24. -] | 9 (10) | 9 (10) | 0.1 ± 5.7 | −1.4 ± 3.4 |
| [22 - 27] | 18 (20) | 19 (22) | 0.2 ± 5.1 | −0.4 ± 3.6 |
| [27 - 32] | 18 (20) | 27 (31) | 0.8 ± 3.9 | 0.4 ± 3.6 |
| [32 - 37] | 18 (20) | 23 (26) | 2.9 ± 5.1 | 1.1 ± 3.6 |
| [37 - 42] | 18 (20) | 18 (21) | −0.5 ± 5.0 | 1.2 ± 5.4 |
| [39.5 - 42] | 9 (10) | 11 (13) | −1.1 ± 5.9 | 1.2 ± 6.4 |
Abbreviations: DBP, diastolic blood pressure; SBP, systolic blood pressure; SD, standard deviation.
Accuracy Analysis
The accuracy analysis is shown in Table 3. Both the validation Criteria 1 and 2 showed “pass” for SBP and DBP according to the ISO 81060-2:2018/Amd.1:2020/Amd.2: 2024 requirements.9–11
Table 3.
Accuracy Results in the General Population
| Pass Requirement | SBP | DBP | |
|---|---|---|---|
| Criterion 1 (261 BP pairs) | |||
| Mean BP difference (mmHg) | ≤5.0 | 1.0 | 0.6 |
| SD (mmHg) | ≤8.0 | 4.9 | 4.1 |
| PASS | PASS | ||
| Criterion 2 (87 subjects) | |||
| SD (mmHg, SBP/DBP) | ≤ 6.87/6.91 | 3.50 | 3.01 |
| PASS | PASS | ||
| Result | PASS | ||
Abbreviations: BP, blood pressure; DBP, diastolic blood pressure; SBP, systolic blood pressure; SD, standard deviation.
For criterion 1, the mean differences between the tested device and the reference BP values (tested device minus reference BP values) were 1.0 ± 4.9 mmHg for SBP and 0.6 ± 4.1 mmHg for DBP. These values fulfilled the requirements of the ISO 81060-2:2018/Amd.1:2020/Amd.2:2024 protocol where difference must be ≤5 mmHg, and its SD ≤8mmHg for SBP and DBP.
For criterion 2, (for individual subjects): The SD of 87 averaged BP differences (test minus reference BP per subject) must be within a threshold defined by the mean test-reference BP difference and calculated to be ≤6.87/6.91 for SBP/DBP. The results showed SD = 3.50 mmHg for SBP and 3.01 mmHg for DBP (Table 3).
Influence of Brachial Circumference
As shown in Table 2, accuracy was consistent across all arm circumference subgroups. Although not part of ISO pass/fail criteria, this analysis supports the device’s suitability across its entire cuff range.8–11
Bland-Altman Scatter Plots
Standardized Bland-Altman scatter plots were used to evaluate the agreement between test and reference BP measurements. Figure 2 depicts the differences against mean values for SBP (Panel A) and DBP (Panel B), demonstrating uniform scatter and no significant proportional bias.
Figure 2.
Standardized Bland-Altman scatter plots of test-reference BP differences against their average in the general population (n=87). (A) SBP = systolic blood pressure; (B) DBP = diastolic blood pressure.
Figure 3 illustrates the relationship between BP differences and brachial circumference for SBP (Panel A) and DBP (Panel B). The plots confirm consistent performance of the test device across the full range of brachial circumferences.
Figure 3.
Scatterplots showing the difference between Test - Reference BP according to the arm circumference in the general population (n=87). (A) SBP = Systolic blood pressure; (B) DBP = Diastolic blood pressure.
Discussion
This study provides the first clinical validation of the BPM Pro2 (WPM07) oscillometric upper-arm blood pressure monitor in a general adult population. The device satisfied all accuracy requirements of the ISO 81060-2:2018/AMD 2:2024 protocol, meeting both population-level (Criterion 1) and within-subject (Criterion 2) standards.8–11 Establishing device accuracy is essential before recommending BP monitors for self-measurement, as inaccurate readings may contribute to diagnostic errors, inappropriate treatment adjustments, and poor hypertension control.2,15 Therefore, both healthcare professionals and consumers are urged to verify the validation status of BP devices before use in clinical and home settings. Regardless of whether automatic devices are used to measure BP in a clinical or outpatient setting, the accuracy of their measurements is crucial to avoid mislabeling, which could have dramatic consequences for patient care. Furthermore, this accuracy is also important to distinguish between the different techniques for measuring blood pressure, which are now well established.16
Several considerations concerning the BPM Pro2 (WPM07) device and the ISO validation protocol call further discussion:
Advantages of Oscillometric BP Monitors
Oscillometric BP monitors such as the BPM Pro2 offer several advantages over auscultatory mercury-based methods. These include ease of use, reduced operator dependency, and suitability for a wide range of environments, including clinical, ambulatory, and home settings. Such characteristics have driven their widespread adoption for self-monitoring. However, oscillometric techniques may show inter-individual variability, with some subjects demonstrating greater dispersion of repeated measurements compared with auscultatory reference values.3,8 This reinforces the importance of clinical validation at the population level, as conducted in this study, and highlights the potential need for individual-level assessment when BP self-monitoring is used for long-term hypertension management.3,17
Special Populations
Although this study validated the BPM Pro2 (WPM07) exclusively in the general adult population, ISO guidance emphasizes the need for separate validation studies in special populations, including children, pregnant women, and individuals with arrhythmias.8–11 Our group has previously validated other devices from the same manufacturer (BPM Core, BPM Connect) in various populations.17–19 Nonetheless, the accuracy demonstrated here cannot be extrapolated to any special population without performing specific targeted validation study. Therefore, future studies are needed to assess the accuracy of the BPM Pro2 (WPM07) device in these special populations.
Number of Validation Studies
The ISO 81060-2:2018/AMD 1:2020/AMD 2:2024 Universal Standard is widely regarded as the most rigorous and comprehensive protocol currently available. However, it does not specify how many successful validation studies are necessary for universal endorsement of a BP device.9–11 Some experts advocate for validation in at least two independent centers to increase confidence in device performance. In practice, many regulatory and scientific bodies accept a single successful study for device listing and recommendation.
Implications for Practice
The successful validation of the BPM Pro2 (WPM07) device supports its use for BP measurement in the general adult population. Its compliance with international standards ensures it can be considered a reliable tool for home-based self-monitoring. This is particularly relevant given the increasing emphasis on out-of-office BP monitoring in hypertension management. Moreover, these findings highlight the importance of rigorous clinical validation in ensuring the accuracy of BP monitors for both clinical and home use.
Conclusion
This study demonstrates that the BPM Pro2 (WPM07) brachial BP device satisfies the accuracy requirements of the ISO 81060-2:2018/AMD 2:2024 protocol in the general adult population; therefore, it can be recommended for home BP measurement in this population with arm circumferences from 22 cm to 42 cm.
Acknowledgments
Our heartfelt thanks to all the participants who took part in the study. Our grateful thanks to the Foundation-Medical Research Institutes (F-MRI®) and the International Society of Vascular Health (ISVH®) for their support.
Funding Statement
The study was financially supported by Withings France. It was also supported by The International Society of Vascular Health (ISVH) France, and The Foundation-Medical Research Institutes (F-MRI) Switzerland.
Disclosure
All authors conducted validation studies for various manufacturers; they received honorarium for this validation study, outside the submitted work. The study, including its design, conduct, analysis, and reporting, was performed completely independently from the manufacturers. Dr Jirar Topouchian reports grants from CMCV, during the conduct of the study. Professor Roland Asmar reports personal fees from Withings, during the conduct of the study. The authors report no other conflicts of interest in this work.
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