This study validated the accuracy and safety of the MED-58 upper-arm automated oscillometric blood pressure monitor - intended for home and clinical use - with fan-shaped and rigid cuffs, per International Organization for Standardization (ISO) 81060-2:2018 (Amd.1:2020; Amd.2:2024). In this prospective, single-center validation study, participants aged ≥12 years were allocated to a fan-shaped cuff group (n = 85) or a rigid cuff group (n = 85). Per group, oscillometric readings with the MED-58 were compared with reference auscultatory measurements using the same-arm sequential method in ISO 81060-2. Blood pressure accuracy was assessed against ISO criterion 1 and 2. Secondary endpoints included pulse rate accuracy (±5% margin vs. manual palpation), device usability/performance, and safety. Both cuff configurations met ISO accuracy requirements. In the fan-shaped group, mean (±SD) device-reference differences were 1.1 ± 5.4 mmHg (SBP) and 0.3 ± 4.0 mmHg (DBP); SDs of per-participant mean differences were 4.4 mmHg (SBP) and 3.3 mmHg (DBP). In the rigid group, mean differences were 0.8 ± 5.2 mmHg (SBP) and 0.6 ± 4.5 mmHg (DBP); SDs of per-participant mean differences were 4.2 mmHg (SBP) and 3.8 mmHg (DBP). Mean pulse-rate differences were 1.65 bpm (fan-shaped) and 1.76 bpm (rigid), both within the prespecified ±5% equivalence margin. No adverse events were reported. The MED-58 demonstrated accuracy consistent with ISO 81060-2:2018 (Amd.1:2020; Amd.2:2024) with either cuff, with good usability and short-term safety.

To assess the accuracy of the Microlife WatchBP O3 upper-arm, oscillometric blood pressure (BP) device, suitable for clinic, home, and ambulatory use, in a pregnant population. This device was assessed according to the ISO 81060-2:2018 protocol in 45 pregnant women, including women with gestational hypertension and pre-eclampsia. Two cuff sizes were available for arm circumferences of 22-32 and 32-42 cm. Nine sequential same-arm measurements were obtained from each participant, alternating between the test device and auscultation. Forty-nine women were included, and four were excluded. Data from 45 women, including 14 women with gestational hypertension and 15 women with pre-eclampsia, were analyzed according to the protocol. The mean difference with SDs were 0.6 ± 7.9 mmHg for SBP and 3.4 ± 6.0 mmHg for DBP. The Microlife WatchBP O3 upper-arm, oscillometric BP device passed the criteria of the ISO 81060-2:2018 standard in normotensive pregnant women, women with gestational hypertension, and women with pre-eclampsia.

The aim of the study was to determine the accuracy of the Hingmed V03D oscillometric monitor for upper arm blood pressure (BP) measurement according to the new International Organization for Standardization (ISO) 81060-2:2018/Amd1:2020/Amd2:2024 protocol. The Hingmed V03D is provided with a wide-range cuff for arm circumferences ranging from 22 to 41 cm. The device was tested in 85 subjects from the general population. The mean age of the participants was 51.7 years (range: 17-71 years). The mean device-observer difference was -1.2 ± 4.0 mmHg for SBP and -2.0 ± 3.7 mmHg for DBP, in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Criterion 2 of the ISO 81060-2:2018/Amd1:2020/Amd2:2024 protocol was also satisfied. The SD of SBP and DBP were 2.6 and 2.9 mmHg, respectively, well below the maximum values required by the protocol (6.84 and 6.65 mmHg for SBP and DBP, respectively). The measurement errors were unrelated to arm size. These results indicate that the Hingmed V03D is a reliable BP monitor because it satisfied the requirements of the ISO 81060-2:2018/Amd1:2020/Amd2:2024 protocol for the general population. This device showed that a single wide-range cuff can provide accurate measurements in standard as well as large arms with circumferences ranging from 22 to 41 cm.

Guidelines recommend initial blood pressure assessment on both arms, with the higher-reading arm used for future measurements. As simultaneous measurement devices are often unavailable, we evaluated if sequential measurements are appropriate for assessing interarm differences. Blood pressure was measured in Shanghai using an automated system. Consecutive readings were taken with 1-min intervals, beginning with the right followed by the left arm, with a third reading if the difference between the first two exceeded 5 mmHg. In 7838 participants, right arm readings were consistently higher, with mean interarm systolic/diastolic differences of 4.59/1.01 mmHg if two readings on each arm, 6.24/1.45 mmHg if two readings on one and three readings on another arm, and 7.22/1.90 mmHg if three readings on each arm. This sequential measurement approach led to more frequent right arm selection for blood pressure measurement and potential overestimation of the interarm differences. Simultaneous measurements may be needed, but future studies are required to confirm this.