Key result
The ANDON KD-595 automated blood pressure monitor met universal standard criteria, with mean differences of 0.96 ± 5.35 mmHg for SBP and 0.82 ± 5.08 mmHg for DBP compared to a mercury sphygmomanometer.
Why the study?
The study was conducted to validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement according to the AAMI/ESH/ISO Universal Standard.
Does the ANDON KD-595 automated upper-arm blood pressure monitor accurately measure blood pressure compared to a standard mercury sphygmomanometer in adult participants?
Cross-Sectional (n=90)
Does the ANDON KD-595 automated upper-arm blood pressure monitor accurately measure blood pressure compared to a standard mercury sphygmomanometer in adult participants?
The ANDON KD-595 automated upper-arm blood pressure monitor meets the AAMI/ESH/ISO Universal Standard requirements and is recommended for clinical and self-measurement use.
May support clinical use of ANDON KD-595; extends validation data but leaves generalizability open.
OBJECTIVE: To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. METHODS: Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard. RESULTS: For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ± 5.35 and 0.82 ± 5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively. CONCLUSION: The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.
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Liu et al. (2023) conducted a cross-sectional in General population (n=90). ANDON KD-595 automated upper-arm blood pressure monitor vs. Standard mercury sphygmomanometer was evaluated on Mean ± SD of the differences between the test device and reference blood pressure readings (Criterion 1) (MD 0.96). The ANDON KD-595 automated blood pressure monitor met universal standard criteria, with mean differences of 0.96 ± 5.35 mmHg for SBP and 0.82 ± 5.08 mmHg for DBP compared to a mercury sphygmomanometer.
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