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Validation of the BPUMP BF1112 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010

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Abstract

Objective

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure (BP) monitor BPUMP BF1112 for home BP monitoring according to the International Protocol of the European Society of Hypertension revision 2010 (ESH-IP2010).

Participants and methods

Systolic and diastolic BPs were sequentially measured in 33 adult Chinese (13 women, mean age 46.7 years) using a mercury sphygmomanometer (two observers) and the BF1112 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases.

Results

The BPUMP BF1112 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 85/99, 96/99, and 97/99, respectively, for systolic BP, and 83/99, 97/99, and 99/99, respectively, for diastolic BP. The device also fulfilled the criteria in part 2 of the validation study. A total of 31 and 30 participants for systolic and diastolic BP, respectively, had at least two of the three device−observer differences within 5 mmHg (required≥24mmHg). No participant for systolic or diastolic BP had all the three device−observer comparisons greater than 5 mmHg.

Conclusion

The BPUMP BP monitor BF1112 has passed the requirements of the ESH-IP2010, and hence can be recommended for home use in adults.

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