P-22: Validation of the microlife BP 3AC1-1® device for blood pressure measurement according to the international validation protocol

1. The aim of this study was to perform a clinical validation of the Microlife BP 3AC1-1 blood pressure (BP) measuring device according to the International validation Protocol. 2. The International validation Protocol is divided into 2 phases: the first phase is performed on 15 subjects fulfilling the inclusion criteria requested by the protocol; the second phase is performed on additional 18 subjects, only if the device passes the first phase. The inclusion criteria require to select subjects according to BP ranges. For each subject, 4 BP measurements were performed simultaneously by 2 observers (trained according to the French Hypertension Society criteria) using standard mercury sphygmomanometers alternately with 3 Microlife measurements. The difference (Δ) between the BP value given by the device and that obtained by the 2 observers (mean of the 2 observers) was calculated for each measure. The 99 differences (Δ) were classified into categories (≤ 5, ≤ 10, ≤ 15 mmHg). The number of Δ (n) in each category was compared to the number required by the International Protocol. An individual analysis was then done to determine for each subject the number of comparisons ≤ 5 mmHg. At least 22 of the 33 subjects should have 2 of their 3 comparisons ≤ 5 mmHg. 3. The mean age of the 33 included subjects (19 men, 14 women) was 53 ± 14 years. The Microlife device fulfilled the required criteria of the primary phase (15 subjects) of the International Protocol. Regarding the 33 subjects, the difference between the 2 observers was 1.69 ± 1.52 mmHg and −0.03 ± 1.37 mmHg for systolic and diastolic BP respectively. The results of the comparison of the device and the observers are shown in the table below: ≤5 mmHg ≤10 mmHg ≤15 mmHg Observers (m ± sd) Δ (m ± sd) SBP n = 74 n = 87 n = 98 142 ± 25 −1.3 ± 5.6 DBP n = 81 n = 93 n = 97 90 ± 16 −0.4 ± 4.8 Number of patients having 2 of their 3 comparisons ≤ 5 mmHg was 29 and 28 for systolic and diastolic BP respectively. 4. The Microlife BP 3AC1-1 device fulfils the recommendations of the international validation protocol.