Objective: The study aimed to validate the Pangao PG-800B18 oscillometric upper-arm blood pressure monitor in the general population in accordance with the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd) 1:2020 protocol.
Methods: Participants were recruited, and the same left-arm sequential method was used for blood pressure measurement in accordance with the protocol. Data validation and analysis were performed according to the protocol, and the Bland-Altman scatter plot was used to show the difference between the test device and reference results.
Results: A total of 86 participants were included in the validation analysis. For the validation criterion 1 of the protocol, the mean ± SD of the differences between the test device and reference readings was -1.21 ± 6.71 mmHg and -0.73 ± 5.83 mmHg for systolic (SBP) and diastolic blood pressure (DBP), respectively. Furthermore, the SD of the differences between the test device and reference readings per participant was 5.81 and 5.02 mmHg for SBP and DBP, fulfilling the criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP.
Conclusion: The Pangao PG-800B18 upper-arm blood pressure monitor fulfilled the requirements of the ISO validation standard and can be recommended for clinical use and self-measurement in the general population.
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