Validation of the HEM-780REL with easy wrap cuff for self-measurement of blood pressure according to the European Society of Hypertension International Protocol.

OBJECTIVE

We tested the accuracy of the HEM-780REL automatic blood pressure monitor with Easy Wrap Cuff.

METHODS

We used the International Protocol for validation of blood pressure measuring devices developed by the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. Thirty-three adults over the age of 30 years participated to have 11 total participants in each of the three required blood pressure ranges for systolic and diastolic blood pressure. Sequential blood pressure readings were taken independently by trained observers using a mercury standard with appropriate size cuff. A third observer performed measurements with the test device. Analyses were performed according to International Protocol specifications for the 99 pairs of measurements. The device was given a pass/fail recommendation based on bands of accuracy compared with the mercury standard (within 5, 10, or 15 mmHg), as well as number of readings per participant within 5 mmHg.

RESULTS

The mean blood pressure difference was 0.52+/-7.7 mmHg for systolic blood pressure and 0.39+/-4.7 mmHg for diastolic blood pressure. Twenty-four out of 33 participants had two out of three readings within 5 mmHg of the mercury standard for systolic blood pressure. Twenty-seven out of 33 participants had two out of three readings within 5 mmHg of the mercury standard for diastolic blood pressure. The device received a passing grade both for accuracy of individual measurements and for accuracy for individuals.

CONCLUSION

The HEM-780REL with Easy Wrap Cuff performs accurately according to the standards of the International Protocol.