Validation of the Omron HEM-907 device for blood pressure measurement

• Published in: American journal of hypertension 2002-04, Vol.15 (4), p.87A-87A
• Main Authors: El Assaad, Mohamed A., Topouchian, Jirar A., Darne, Bernadette M., Asmar, Roland G.
• Format: Article
• Language: English
• Subjects: Blood Pressure Measuring Device; International Protocol; Validation
• ISSN: 0895-7061; 1879-1905; 1941-7225
• DOI: 10.1016/S0895-7061(02)02510-4

Objective: The aim of this study was to perform a clinical validation of the Omron HEM-907 blood pressure (BP) measuring device according to the recent International validation Protocol. Methods: 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 the Omron HEM-907 device. 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 mm Hg). The number of Δ (n) in each category was compared to the number required by the International Protocol. Results: The mean age of the 33 included subjects (19 men, 14 women) was 51 ± 14 years. The Omron 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 ± 2 mm Hg for the SBP and for the DBP. The results of the comparison of the device and the observers are shown in the table below: ≤5 mm Hg ≤10 mm Hg ≤15 mm Hg Observers (m ± sd) Δ (m ± sd) SBP n = 61 n = 85 n = 94 140 ± 27 −1 ± 7 DBP n = 52 n = 85 n = 96 89 ± 15 −5 ± 6 Conclusions: The Omron HEM-907 device passed the 2 phases of the International Protocol, and thus can be used for clinical BP measurement.