Validation of the PHILIPS DL8760 upper arm blood pressure monitor, in oscillometry mode, for self-measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The aim of this study was to determine the accuracy of the PHILIPS DL8760, an oscillometric blood pressure (BP) measuring device designed for self-measurement in the general population according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. PARTICIPANTS AND METHODS: The PHILIPS DL8760 measures BP at the brachial level. The validation was performed in 33 subjects. The mean age of the participants was 55.8 ± 14 years. SBP 146.1 ± 26 mmHg (range: 103-193), DBP was 86.8 ± 17.0 mmHg (range: 47-123), and arm circumference was 28.3 ± 4.0 cm (range: 22-39). RESULTS: The PHILIPS DL8760 fulfilled the criteria of the ESH-IP by passing phases one and two for both SBP measurements and DBP measurements. The device overestimated SBP by 1.5 ± 5.0 mmHg and underestimated DBP by 0.7 ± 3.9 mmHg. CONCLUSION: The PHILIPS DL8760 BP device, with its specially designed cuff covering a broad range of arm circumferences, fulfilled the requirements of the International Protocol Revision 2010.

Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP).

BACKGROUND: Following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010, QardioArm® and Omron M6 Comfort IT® oscillometric devices were evaluated in the general population and in patients with type II diabetes, respectively, for self-blood pressure (BP) measurement. METHODS: Both devices, QardioArm® and Omron M6 Comfort®, measure BP at the brachial level. The ESH-IP Revision 2010 includes a total number of 33 subjects. For each measure, the difference between observer and device BP values was calculated. In all, 99 pairs of BP differences are classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely. RESULTS: QardioArm® and Omron M6 Comfort® fulfilled the requirements of the ESH-IP and passed the validation process successfully. For QardioArm®, a total of 69 out of 99 comparisons for systolic blood pressure (SBP) showed an absolute difference within 5 mmHg and 82 out of 99 for diastolic blood pressure (DBP). As for Omron M6 Comfort®, a total of 83 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 77 out of 99 for DBP. The mean differences between the device and mercury readings were 0.7±5.9 mmHg for SBP and 0.3±4.1 mmHg for DBP for QardioArm® and -1.4±4.7 mmHg for SBP and -2.1±4.3 mmHg for DBP for Omron M6 Comfort®. With regard to part 2 of ESH-IP 2010, 27 out of 33 subjects had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 subjects for DBP for the QardioArm®, and 29 out of 33 patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 26 out of 33 patients for DBP for Omron M6 Comfort®. CONCLUSION: QardioArm® and Omron M6 Comfort® readings differing from the mercury standard by <5, 10, and 15 mmHg fulfill the ESH-IP Revision 2010 requirements. Consequently, these two devices are suitable for use in the general population and non-insulin-dependent type II diabetic patients, respectively.

Questionable accuracy of home blood pressure measurements in the obese population - Validation of the Microlife WatchBP O3® and Omron RS6® devices according to the European Society of Hypertension-International Protocol.

OBJECTIVE: Two oscillometric devices, the Microlife WatchBP O3® and the Omron RS6®, designed for self-blood pressure measurement were evaluated according to the European Society of Hypertension (ESH)-International Protocol (IP) Revision 2010 in the obese population. METHODS: The Microlife WatchBP O3 measures blood pressure (BP) at the brachial level and the Omron RS6 measures BP at the wrist level. The ESH-IP revision 2010 includes a total of 33 subjects. The difference between observers' and device BP values was calculated for each measure. A total of 99 pairs of BP differences were classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely in each of the two studies. RESULTS: Microlife WatchBP O3 and Omron RS6 failed to fulfill the criteria of the ESH-IP. The mean differences between the device and the mercury readings were: 0.3±7.8 mmHg and -1.9±6.4 mmHg for systolic BP and diastolic BP, respectively, for Microlife WatchBP O3, and 2.7±9.9 mmHg for SBP and 3.5±11.1 mmHg for diastolic BP for Omron RS6. CONCLUSION: Microlife WatchBP O3 and Omron RS6 readings differing from the mercury standard by more than 5, 10, and 15 mmHg failed to fulfill the ESH-IP revision 2010 requirements in obese subjects. Therefore, the two devices cannot be recommended for use in obese subjects.