Key result
iHealth Track BP monitor meets ISO validation criteria in pregnant patients with ~1 mmHg mean difference.
Why the study?
Validation of blood pressure devices is essential for reliable blood pressure detection in pregnant populations.
Does the iHealth Track KN-550BT automated BP monitor accurately measure blood pressure compared to a mercury sphygmomanometer in pregnant patients?
Cross-Sectional (n=45)
Does the iHealth Track KN-550BT automated BP monitor accurately measure blood pressure compared to a mercury sphygmomanometer in pregnant patients?
Mean Difference: -0.9
The iHealth Track KN-550BT upper-arm automated BP monitor meets ISO validation criteria for accuracy in pregnant patients, including those with gestational hypertension and preeclampsia.
Supports device use in pregnancy; leaves open need for larger trials before routine adoption.
OBJECTIVE: Validation of blood pressure (BP) devices is essential for reliable BP detection in pregnant populations. This study, therefore, set out to assess the measurement performance of the iHealth Track KN-550BT oscillometric upper-arm automated BP monitor for pregnant patients with the standard International Organization for Standardization (ISO) 81060-2:2018+AMD1:2020/AMD2:2024. METHODS: This validation study enrolled a total of 45 pregnant patients. All BP measurements were performed sequentially on the left arm using the ISO unified standardized protocol. Device-reference discrepancies between the tested automated sphygmomanometer and the mercury sphygmomanometer were calculated and evaluated in strict accordance with the ISO standard specifications. RESULTS: The study cohort consisted of 15 normotensive pregnant patients, 15 patients with gestational hypertension, and 15 patients diagnosed with preeclampsia. For the ISO Validation Criterion 1, the mean differences between the test device and mercury standard were -0.90 ± 4.82 mmHg for SBP and -0.91 ± 4.14 mmHg for DBP, respectively. For Criterion 2, the standard deviations of the averaged per-participant differences between device and reference measurements were 3.95 mmHg for SBP and 3.10 mmHg for DBP, respectively. CONCLUSION: The iHealth Track KN-550BT upper-arm oscillometric automated BP monitor fully complies with the requirements of ISO 81060-2:2018+AMD1:2020/AMD2:2024, and can be recommended for clinical application and home self-BP measurement among pregnant patients.
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A 2026 study conducted a cross-sectional in Pregnancy (normotensive, gestational hypertension, preeclampsia) (n=45). iHealth Track KN-550BT oscillometric upper-arm automated BP monitor vs. Mercury sphygmomanometer was evaluated on Device-reference discrepancies (mean differences) for SBP and DBP according to ISO Validation Criterion 1 (MD -0.90 mmHg for SBP and -0.91 mmHg for DBP). The iHealth Track KN-550BT automated BP monitor met ISO validation criteria in pregnant patients, with mean differences compared to a mercury standard of -0.90 ± 4.82 mmHg for SBP.
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