Key result
iHealth Track KN-550BT monitor meets AAMI/ESH/ISO validation criteria with ~1 mmHg systolic mean difference.
Why the study?
To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in the general population according to the AAMI/ESH/ISO Universal Standard.
Does the iHealth Track KN-550BT blood pressure monitor provide accurate measurements compared to reference standards in the general population?
Observational (n=89)
Does the iHealth Track KN-550BT blood pressure monitor provide accurate measurements compared to reference standards in the general population?
Mean Difference: -1.22
The iHealth Track KN-550BT upper-arm blood pressure monitor meets the AAMI/ESH/ISO Universal Standard and is accurate for clinical use and self-measurement.
Supports accuracy for clinical and home use; leaves open generalizability to broader or high-risk populations.
OBJECTIVE: To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020). METHODS: Participants were recruited and the same left-arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results. RESULTS: A total of 89 qualified participants were included in the final analysis. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference readings was -1.22 ± 5.76 mmHg and -0.08 ± 4.40 mmHg for systolic and diastolic blood pressure, respectively. For Criterion 2, the mean ± SD of the differences between the test device and reference readings per participant was -1.22 ± 5.06 mmHg and -0.08 ± 3.84 mmHg for systolic and diastolic blood pressure, respectively. CONCLUSION: The iHealth Track KN-550BT upper-arm blood pressure monitor passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020) and can be recommended for clinical use and self-measurement in general population.
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Shi et al. (2023) conducted an observational in General population (n=89). iHealth Track KN-550BT upper-arm blood pressure monitor vs. Reference blood pressure measurement was evaluated on Difference between test device and reference readings (Criterion 1) (MD -1.22 mmHg (SBP) and -0.08 mmHg (DBP)). The iHealth Track KN-550BT blood pressure monitor met AAMI/ESH/ISO validation criteria, with mean differences of -1.22 mmHg for systolic and -0.08 mmHg for diastolic blood pressure.
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