Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT).

BACKGROUND: Two electronic devices for self-measurement of blood pressure - a brachial monitor, the Omron M6, and a wrist monitor, the Omron R7 - were evaluated in two separate studies according to the International Protocol of the European Society of Hypertension. DESIGN: The International Validation Protocol is divided into two phases: the first phase is performed on 15 selected participants (45 pairs of blood pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 pairs of blood pressure measurements) making a total number of 33 participants (99 pairs of blood pressure measurements) on whom the final validation is performed. METHODS: The same methodology recommended by the European Society of Hypertension protocol was applied for both studies. In each study and for each participant, four blood pressure measurements were taken simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements taken by the tested device. The difference between the blood pressure value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The 99 pairs of blood pressure differences were classified into three categories (

Validation of two devices for self-measurement of brachial blood pressure according to the International Protocol of the European Society of Hypertension: the SEINEX SE-9400 and the Microlife BP 3AC1-1.

BACKGROUND: Two electronic devices for self-measurement of blood pressure at the brachial artery -- the Seinex SE-9400 and the Microlife BP 3AC1-1 -- were evaluated in two separate studies according to the International Protocol of the European Society of Hypertension. DESIGN: The international validation protocol is divided into two phases: the first phase is performed on 15 selected participants (45 blood pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 blood pressure measurements) making a total number of 33 participants (99 blood pressure measurements) on whom the final validation is performed. METHODS: The same methodology recommended by the European Society of Hypertension protocol was applied for both studies. In each study and for each participant, four blood pressure measurements were taken simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements by the tested device. The difference between the blood pressure value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The 99 differences were classified into three categories (< or =5, < or =10, < or =15 mmHg). The number of differences in each category was compared with the number required by the ESH protocol. An individual analysis was then done to determine, for each participant, the number of comparisons < or =5 mmHg. At least 22 of the 33 participants should have two of their three comparisons < or =5 mmHg. RESULTS: In both studies, the two tested devices passed the first phase of the validation process. For the complete analysis (phase 1 and phase 2), the average differences between the device and mercury sphygmomanometer readings were in the first study for the Seinex SE-9400 device 0.9+/-5.2 and -1.7+/-4.7 mmHg for systolic and diastolic blood pressure, respectively, and -0.2+/-4.5 and -2.0+/-4.8 mmHg for the Microlife BP 3AC1-1 device in the second study. For both devices, readings differing by less than 5, 10 and 15 mmHg for systolic and diastolic blood pressure values fulfill the recommendation criteria of the International Protocol as well as the individual analysis. CONCLUSIONS: The Seinex SE-9400 and the Microlife BP 3AC1-1 devices fulfilled the validation recommendations of the International Protocol.

Evaluation of two devices for self-measurement of blood pressure according to the international protocol: the Omron M5-I and the Omron 705IT.

BACKGROUND: Two devices for self-measurement of blood pressure at the brachial artery-the Omron M5-I and the Omron 705IT-were evaluated according to the international protocol of the European Society of Hypertension. DESIGN: The international validation protocol is divided into two phases: the first phase is performed on 15 selected subjects and if the device passes this phase, 18 supplementary subjects are included making a total number of 33 subjects on which the final validation is performed. METHODS: For each subject, four blood pressure (BP) measurements were performed simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements by the tested device. The difference between the BP value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The 99 differences were classified into categories (

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

BACKGROUND: The aim of this study was to validate the Omron HEM-907 blood pressure (BP) measuring device according to the international validation protocol. DESIGN: The international validation protocol is divided into two phases: the first phase is performed on 15 selected subjects and if the device passes this phase, 18 more subjects are selected making a total number of 33 subjects on which the final validation is performed. METHODS: For each subject, BP measurements were performed simultaneously by two trained observers using mercury sphygmomanometers alternately with the Omron HEM-907 device. In all, 99 measurements were obtained for comparison. The difference between the BP value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. RESULTS: The difference between the two observers was -1 +/- 2 mmHg for the systolic BP (SBP) and for the diastolic BP (DBP). The Omron HEM-907 passed the first phase of the validation process. For the second phase, the average differences between the device and mercury sphygmomanometer readings were -1 +/- 7 and -5 +/- 6 mmHg for SBP and DBP respectively. Readings for the HEM-907 device differed by less than 5 mmHg for 61 of the systolic readings and 52 of the diastolic readings; by less than 10 mmHg for 85 of the systolic readings and 85 of the diastolic readings; and by less than 15 mmHg for 94 of the systolic readings and 96 of the diastolic readings. CONCLUSIONS: The Omron HEM-907 device passes the two phases of the international validation protocol.