Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in adults and obese adults

OBJECTIVE: Wrist blood pressure devices are becoming popular for the self-measurement of blood pressure. Despite widespread use of these devices, there is limited published evidence for their accuracy and reliability. In this study, we assessed the accuracy of the Omron 637IT wrist blood pressure device against the mercury sphygmomanometer in adults and obese adults according to the International Protocol criteria. METHODS: A hundred and thirty-one participants were studied and classified on the basis of the International Protocol range. Blood pressure measurements at the wrist using the Omron 637IT were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. Initially, 33 participants with random arm circumferences were selected for the first validation study. Then, the device was evaluated in adults with arm circumferences equal to or higher than 34 cm. During each validation study, 99 measurements were obtained for comparison from the 33 participants. The first phase was performed on 15 participants, and, if the device passed this phase, 18 more participants were selected. RESULTS: Mean discrepancies and standard deviations of the sphygmomanometer device were 0.5+/-6.2 mmHg for systolic blood pressure and 0.1+/-3.7 mmHg for diastolic blood pressure in the adult group. The device passed phases 1 and 2 in 33 participants. Mean discrepancies and standard deviations of the sphygmomanometer device were 1.8+/-6.6 mmHg for systolic blood pressure and 1.6+/-4.7 mmHg for diastolic blood pressure in the obese adult group. The device passed phases 1 and 2 in 33 participants in this group. CONCLUSION: The Omron 637IT passed according to the International Protocol criteria and can be recommended for use in adults and obese adults.     

Validation of the Omron M6 (HEM-7001-E) upper arm blood pressure measuring device according to the International Protocol in elderly patients

OBJECTIVE: Despite the widespread use of automated self-measurement monitors, there is limited published evidence on their accuracy and reliability on different patient groups. The objective of this study was to evaluate the accuracy and reliability of the Omron M6 (HEM-7001-E) upper-arm blood pressure (BP) device against mercury sphygmomanometer on elderly patients according to the criteria of the International Protocol. DESIGNS AND METHODS: Thirty-three patients above 65 years of age, who were classified based on the BP categories of the International Protocol, were recruited for the study. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. During the validation study, 99 measurements were obtained from 33 patients for comparison. The first phase was carried out on 15 patients and if the device passed this phase, 18 more patients were selected. RESULTS: Mean discrepancies and standard deviations of the device sphygmomanometer were 1.4+/-5.3 mmHg for systolic BP (SBP) and -1.4+/-4.5 mmHg for diastolic BP (DBP) in the study group. The device passed phase 1 in 15 patients. In phase 2.1, from the total 99 comparisons, 76, 92, and 97 for SBP and 77, 94, and 99 for DBP were less than 5, 10, and 15 mmHg, respectively. The Omron M6 passed phases 2.1 and 2.2 in the elderly group of patients. CONCLUSION: The Omron M6 (HEM-7001-E) upper-arm BP monitor passed according to the International Protocol criteria and can be recommended for use in elderly patients.     

Validation of the Omron M6 (HEM-7001-E) upper-arm blood pressure measuring device according to the International Protocol in adults and obese adults

BACKGROUND: Electronic blood pressure (BP) measurement devices are the preferred choice of patients owing to their user-friendly nature; however, there is a requirement to investigate the accuracy and reliability of these devices. The objective of this study is to evaluate the accuracy of the Omron M6 upper-arm BP device against the mercury sphygmomanometer in adults and obese adults according to the International Protocol criteria. METHODS: One hundred and twenty-one patients, older than 30 years of age, were studied and classified on the basis of the range of the International Protocol. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. A total of 33 participants were selected for each validation study. During the validation study, 99 measurements were performed on 33 participants for comparison. The first phase was performed on 15 participants, and if the device passed this phase, 18 more participants were selected. Having a two-fold purpose, this study was conducted on both adult and obese adult patients. RESULTS: Mean discrepancies and standard deviations of the monitor-mercury sphygmomanometer were 1.1+/-4.0 mmHg for systolic BP (SBP) and -0.5+/-3.5 mmHg for diastolic BP (DBP) in the adult group. The device passed phase 1 in 15 participants. In phase 2.1, out of a total of 99 comparisons, 88, 96, and 97 for SBP, and 88, 98, and 99 for DBP were <5, <10, and <15 mmHg, respectively. Mean discrepancies and standard deviations of the monitor-mercury sphygmomanometer were 1.7+/-4.8 mmHg for SBP and -0.8+/-4.3 mmHg for DBP in the obese adult group. The device passed phase 1 in 15 participants. In phase 2.1, out of a total of 99 comparisons, 82, 90, and 97 for SBP, and 80, 97, and 99 for DBP were <5, <10, and <15 mmHg, respectively. It was found that the Omron M6 automatic monitor, which measures BP at the upper arm, produced results in accordance with the criteria of phases 2.1 and 2.2 in both SBP and DBP, when applied to adults and to obese adults. CONCLUSION: It was concluded that the Omron M6 device, which measures BP at the upper arm, was deemed to be in accordance with the International Protocol criteria and can be recommended for use by adults and obese adults.     

Comparison of the Omron HEM-637 wrist monitor to the auscultation method with the wrist position sensor on or disabled

BACKGROUND: To determine whether the Omron HEM637 wrist model with the wrist positioning sensor turned on (Son) is more accurate relative to upper arm auscultation by trained professionals than when the sensor was manually turned off (Soff). METHODS: Forty-four subjects, at least 30 years old, had repeated, sequential dual-observer upper arm auscultatory measurements (5 to 6 each) and oscillometric Omron HEM637 wrist measurements (4 each). Nineteen subjects were assigned to the wrist sensor On group and 25 were assigned to the wrist sensor Off group. A total of 425 auscultatory and 164 wrist measurements were analyzed. RESULTS: The Omron HEM-637 measured the blood pressure (BP) with equal accuracy to the observers using the auscultatory technique (difference -1.37 +/- 8.51/3.47 +/- 8.07 mm Hg, P =.71/.14). The wrist sensor did improve the accuracy of the measurements compared to the subjects that had the sensor deactivated. The sensor On group (Son) measured the systolic BP (0.82 +/- 9.83 mm Hg) and diastolic BP (-0.72 +/- 9.07 mm Hg) statistically the same as by auscultation (P =.86 for systolic BP and P =.83 for diastolic BP). The sensor Off (Soff) group measured the SBP (-3.03 +/- 7.12 mm Hg) and diastolic BP (-5.56 +/- 6.68 mm Hg) statistically different than auscultation (P =.46 for systolic BP and P =.02 for diastolic BP). The higher (negative) measurement for both the systolic BP and diastolic BP suggests that the average position of the wrist was 1.75 inches (4.4 cm) below the heart level in this group with the sensor off. CONCLUSIONS: This study demonstrated that the Omron HEM-637 monitor with a wrist sensor more accurately measured BP compared to the same model with the sensor turned off.     

Evaluation of the performance of a wrist blood pressure measuring device with a position sensor compared to ambulatory 24-hour blood pressure measurements

This randomized, single-center, open, within-subject study evaluated the performance of the Braun PrecisionSensor 2000 blood pressure (BP) measurement wrist device (BP 2000, Braun GmbH, Germany) with and without the position sensor, and compared the results with data obtained from 24-h ambulatory BP measurement (ABPM, A&D TM 2430). In a crossover design, 43 subjects performed BP measurements with the BP 2000 during two 7-day periods, one with the position sensor and the other without the position sensor. The correlation coefficients between all wrist self-measurements and ABPM were 0.73 for systolic and 0.65 for diastolic BP (with position sensor) compared to 0.70 and 0.60 for readings without position sensor, respectively. The categorization of subjects as normotensive or hypertensive, using the wrist device in subjects without specific training, achieved a correct classification of 84% (with position sensor) and 81% (without position sensor) in comparison to ABPM. When the measurements were performed in the clinic by an experienced observer, the correct classification was 79% in comparison to ABPM. The crossover study design did not show any significant variation between the two devices with regard to reproducibility of readings at the wrist. In conclusion, self-BP measurements with BP 2000, by untrained subjects, produced results consistent with those found recently with self-BP measurements with upper arm devices, when both data sets are compared with ABPM. The rates of false classification of normotension/hypertension with the wrist device were small and at least as reliable as office measurements.     

Accuracy of the Omron RX-M, an automated blood pressure measuring device, measuring blood pressure at the wrist, according to a modified British Hypertension Society protocol

OBJECTIVE: To determine the accuracy of the Omron RX-M, a device measuring blood pressure oscillometrically at the wrist. METHODS: In 89 subjects (mean age 55+/-14 years) blood pressure measurements at the wrist with the Omron RX-M were compared to sequential blood pressure measurements with a mercury sphygmomanometer at the (same) upper-arm and to simultaneous measurements with the Omron HEM-705 CP at the opposite arm.Measurements with analyzed according to the British Hypertension Society (BHS) - protocol 1993, to the protocol of the Association for the Advancement of Medical Instrumentation (AAMI) and (retrospectively) to the new 'International Protocol'. RESULTS: Mean differences (+/-SD) between the measurements with the mercury sphygmomanometer and the Omron RX-M were -7.5+/-8.4 mmHg for diastolic blood pressure (DBP) and -2.5+/-12.2 mmHg for systolic blood pressure (SBP), thus not fulfilling the AAMI-criteria (< or =5+/-8). According to the BHS-criteria a grade D was achieved for both DBP and SBP. Compared to the Omron HEM 705 CP results were -6.3+/-7.1 for DBP (grade D) and -4.1+/-12.7 for SBP (grade D). The Omron RX-M also failed to pass the new 'International Protocol' in phase 1. CONCLUSION: Although easy to use, based on this study the Omron RX-M can not be recommended to determine blood pressure accurately.     

Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol

BACKGROUND: The Omron 705IT (HEM-759-E, Omron Corporation, Kyoto, Japan) is an automated oscillometric upper arm blood pressure monitor for the professional and home use markets. The aim of this study was to validate the accuracy of this device according to the British Hypertension Society and the Association for the Advancement of Medical Instrumentation SP10 validation criteria. METHODS: Study participants were recruited until a total of 85 were obtained that filled the blood pressure categories specified by the British Hypertension Society protocol. Recruitment to the study was from the general medical and specialist clinics and from the staff at Guy's & St Thomas' Hospital in London, UK. Nine sequential same-arm blood pressure readings were taken from each participant by two trained observers, alternating between mercury reference sphygmomanometers and the Omron 705IT (HEM-759-E). The differences between the reference and test device readings, for both systolic and diastolic pressures, were compared with British Hypertension Society and Association for the Advancement of Medical Instrumentation criteria to determine the outcome of the study. RESULTS: The Omron 705IT (HEM-759-E) is graded 'A' for systolic and 'A' for diastolic blood pressures according to the British Hypertension Society criteria. The mean (standard deviation) of the difference between the observer and the device measurements was 0.60 (6.0) mmHg for systolic and -3.15 (6.6) mmHg for diastolic pressures, respectively. The device, therefore, also satisfies the Association for the Advancement of Medical Instrumentation SP10 standard, that requires differences of less than +/-5 (8) mmHg. CONCLUSIONS: The Omron 705IT (HEM-759-E) achieved an 'A/A' performance classification under the British Hypertension Society criteria and passes the Association for the Advancement of Medical Instrumentation requirements for the study population. It can be recommended for professional and home-use in an adult population.     

A comparative study of an ambulatory blood pressure measuring device and a wrist blood pressure monitor with a position sensor versus a mercury sphygmomanometer

BackgroundSelf-measurements of blood pressure (BP) and 24-hour BP measurements are better predictors of cardiovascular mortality and morbidity than office BP measurements. The objective of this study was to compare the accuracy and precision of a wrist BP monitor with a position sensor (Omron 637IT) and of an ambulatory BP measuring monitor (ABPM; Nissei DS-250) with a mercury sphygmomanometer.MethodsA total of 139 patients (69 women and 70 men) were included in the study. The BP of each subject was first measured with a mercury device using the same (left) arm. After this, the wrist monitor was used for BP measurement. Upon completion of the BP readings, 24-hour BP monitoring was performed using Nissei DS-250 monitors. Mean and standard deviations were calculated for all devices. In order to assess the agreement between the measurement methods, the Bland–Altman method and graphics were utilized.ResultsThe mean systolic BP measured by the mercury device was 133.2 ± 18.4 mmHg and the diastolic BP was 85.4 ± 12.5 mmHg, whereas the digital device measured systolic BP as 135.7 ± 17.2 mmHg and diastolic BP as 87.0 ± 12.5 mmHg. The 24-hour BP measurement was 134.6 ± 16.6 mmHg for systolic BP and 85.6 ± 11.1 mmHg for diastolic BP. The difference with regard to systolic BP between the mercury and the Omron devices was − 2.5 ± 5.3 mmHg, which is within the AAMI standard. However, while the mean values of the differences between the mercury and ABPM devices remained under 5 mmHg, their standard deviation was above ±  8 mmHg. For diastolic BP, the difference between all of the devices was below 5 ± 8 mmHg.ConclusionsThe wrist BP monitor produced results consistent with those of the mercury sphygmomanometer when both were compared with the results of the ABPM. As BP measurement with these devices is a practical and repeatable method, they can be used instead of ABPM in the diagnosis and monitoring of hypertension. However, there is a need for further comparative studies.     

Validation of the Microlife WatchBP Home device for self home blood pressure measurement according to the International Protocol

OBJECTIVE: Current guidelines recommend that self monitoring of blood pressure at home should only be performed using validated devices. This study assessed the accuracy of the Microlife WatchBP Home device for self home blood pressure measurement according to the European Society of Hypertension International Protocol. METHODS: Thirty-three participants were included (15 in phase 1 and an additional 18 in phase 2). Simultaneous blood pressure measurements were taken by two observers (Y-tube-connected mercury sphygmomanometers) four times sequentially, with three measurements taken using the tested device. Absolute differences between observer and device measurements were classified into three zones (within 5, 10 and 15 mmHg). The number of measurements with a difference within 5 mmHg was calculated for each individual. RESULTS: In phase 1, the device produced 38, 43 and 43 measurements within 5, 10 and 15 mmHg, respectively, for systolic blood pressure and 35, 45 and 45 for diastolic blood pressure. In phase 2.1, the device produced 75, 91 and 97 measurements within 5, 10 and 15 mmHg for systolic, and 74, 93 and 99 for diastolic blood pressure. In phase 2.2, 30 participants had at least two of their differences within 5 mmHg and two participants had no differences within 5 mmHg for systolic blood pressure, whereas for diastolic blood pressure the number of participants were 27 and three, respectively. Mean difference for systolic blood pressure was -0.3+/-5.6 mmHg and for diastolic -2.4+/-4.8 mmHg. CONCLUSIONS: The Microlife WatchBP Home device for self home blood pressure measurement fulfills all the validation criteria of the International Protocol and can, therefore, be recommended for clinical use in the adult population.     

Validation of the Microlife BPA100 Plus device for self-home blood pressure measurement according to the International Protocol

OBJECTIVE: Current guidelines recommend that only validated devices for blood pressure measurement should be used. This study presents the validation results of the Microlife BPA100 Plus monitor for self-home blood pressure measurement, according to the European Society of Hypertension International Protocol. METHODS: Fifteen study participants were included in phase 1 and an additional 18 in phase 2 (total 33). Simultaneous blood pressure measurements were taken by two trained observers (Y tube connected mercury sphygmomanometers) four times, sequentially with three measurements taken using the tested device. Absolute differences between observer and device blood pressure were classified into three zones (within 5, 10 and 15 mmHg). The number of readings with a difference within 5 mmHg was calculated for each individual. RESULTS: In phase 1, the device produced 32, 42 and 43 measurements within 5, 10 and 15 mmHg, respectively, for systolic blood pressure and 31, 45 and 45 for diastolic blood pressure. In phase 2.1, the device produced 71, 87 and 96 measurements within 5, 10 and 15 mmHg, respectively, for systolic blood pressure, and 71, 98 and 99 measurements for diastolic blood pressure. In phase 2.2, 26 participants had at least two of their differences within 5 mmHg and three participants had no differences within 5 mmHg for systolic blood pressure, whereas for diastolic blood pressure 24 and three participants, respectively. Mean systolic blood pressure differences were -2.0+/-6.0 mmHg and diastolic blood pressure differences were -3.1+/-4.1 mmHg. CONCLUSIONS: The Microlife BPA100 Plus device for self-home blood pressure measurement comfortably passes the validation requirements of the International Protocol and therefore can be recommended for clinical use in the adult population.     

Validation of the A&D UM-101 professional hybrid device for office blood pressure measurement according to the International Protocol

OBJECTIVE: Assessment of the accuracy of the A&D UM-101 mercury-free professional device for auscultatory blood pressure (BP) measurement according to the European Society of Hypertension International Protocol. Further to auscultation, the device has a button to mark readings during deflation. METHODS: Fifteen adults were included in phase 1 and another 18 in phase 2. Simultaneous BP measurements were taken by two observers (connected mercury sphygmomanometers) four times, sequentially with three measurements using the tested device (two connected tested devices, one used with and the other without the mark button). RESULTS: In phase 1, the device produced 44/45/45 measurements within 5/10/15 mmHg, respectively, for systolic BP (SBP) and 39/43/45 for diastolic (DBP). In phase 2.1, 87/97/99 measurements within 5/10/15 mmHg, respectively, for SBP, and 91/97/99 for DBP (using the mark button 65/93/98 for SBP and 76/96/99 for DBP). In phase 2.2, 29 participants had at least two of their SBP differences within 5 mmHg and none had any differences within 5 mmHg, whereas 32 and none, respectively, for DBP (with mark 24/4 participants for SBP; 29/1 for DBP). Mean SBP differences were -1.5+/-3.5 mmHg and DBP -1.3+/-3.0 (with mark -3.6+/-4.2 and -2.8+/-3.7). The difference in SBP measured by the tested device with versus without using the mark button was 3.0+/-3.3 mmHg (P<0.001) and DBP 1.9+/-2.5 mmHg (P<0.001). CONCLUSION: The device comfortably passed the validation protocol requirements. Using the mark button, the device, however, failed to meet the validation criteria. Therefore, it is recommended for clinical use without using the mark button.     

Validation of the Samsung SBM-100A and Microlife BP 3BU1-5 wrist blood pressure measuring devices in adults according to the International Protocol

OBJECTIVE: A variety of automatic blood measurement devices with diverse features have been introduced to the medical markets recently. Among these devices, models that measure at the wrist have become increasingly popular in self measurements. The objective of this study was to evaluate the accuracy of the Samsung SBM-100A and Microlife BP 3BU1-5 wrist blood pressure devices against the mercury sphygmomanometer in adults according to the International Protocol criteria. METHODS: Fifty-four patients over 30 years of age were studied and classified based on the International Protocol range. Blood pressure measurements at the wrist with the Samsung SBM-100A and Microlife BP 3BU1-5 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. A total of 33 participants with randomly distributed arm circumferences were selected for both of the validation studies. During each validation study, 99 measurements were obtained for comparison from 33 participants. The first phase was performed on 15 participants and if the device passed this phase, 18 more participants were selected. RESULTS: Mean discrepancies and standard deviations of the device-sphygmomanometer were 0.9+/-9.2 and -2.7+/-9.3 mmHg for systolic blood pressure and -1.4+/-8.0 mmHg and 1.4+/-5.7 for diastolic blood pressure in the Samsung and Microlife study groups, respectively. The Samsung SBM-100A passed Phase 1 in 15 participants. Despite the fact that Microlife BP 3BU1-5 passed Phase 1 for diastolic pressure, it failed according to the systolic pressure criteria. Eighteen patients were added and Phase 2 was continued, in which Samsung SBM-100A failed to meet the criteria of Phases 2.1 and 2.2 for adults in systolic and diastolic blood pressure. It was found that the Microlife BP 3BU1-5 does not meet the criteria of either of Phases 2.1 and 2.2 for systolic blood pressure and Phase 2.2 for diastolic blood pressure. CONCLUSION: In this study, Samsung SBM-100A and Microlife blood pressure 3BU1-5 wrist blood pressure monitoring devices were found to be incompetent to meet the criteria of the International Protocol and it has not been possible to suggest any one of them for clinical use in adults.     

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.     

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 (相似文献   

Validation of the OSCAR 2 oscillometric 24-hour ambulatory blood pressure monitor according to the International Protocol for the validation of blood pressure measuring devices

OBJECTIVES: The accuracy of blood pressure measuring devices is of prime importance and should be validated before devices are used clinically. We carried out an independent evaluation of the OSCAR 2 oscillometric ambulatory blood pressure monitor (SunTech Medical model 222) according to the European Society of Hypertension International Protocol. METHODS: Adult subjects were recruited from patients and staff at The James Cook University Hospital, Middlesbrough, UK. Nine sequential same-arm blood pressure measurements were taken alternating between simultaneous readings by two independent, trained observers using mercury sphygmomanometers and the device operated by a third observer. In phase one, 15 subjects participated (five in each of the low, medium and high blood pressure ranges) with 18 subjects participating in phase two. Data from 33 subjects (11 in each of the three blood pressure ranges) were analysed for systolic (19 male, 14 female, mean age 56.0 years) and for diastolic (17 male, 16 female, mean age 51.1 years) blood pressure. RESULTS: The OSCAR 2 passed the first phase of the validation process. In phase 2.1, the OSCAR 2 monitor had 71 readings within 5 mmHg, 86 within 10 mmHg and 94 within 15 mmHg for systolic blood pressure (SBP) and 72 readings within 5 mmHg, 88 within 10 mmHg and 96 within 15 mmHg for diastolic blood pressure (DBP). Mean (+/-SD) differences between observers and device were 0.9+/-2.3 mmHg for SBP and -0.5+/-2.3 mmHg for DBP. In phase 2, 24 subjects had at least two of the differences within 5 mmHg and three subjects had no differences within 5 mmHg for SBP while for DBP 25 subjects had at least two of the differences within 5 mmHg and two subjects had no differences within 5 mmHg. CONCLUSIONS: The OSCAR 2 passes all requirements for validation by the International Protocol and can be recommended for clinical use in an adult population.     

Validation of the AGILIS ambulatory blood pressure monitor according to the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults

BACKGROUND: We evaluated the clinical validity of the AGILIS ambulatory blood pressure monitor according to the European Society of Hypertension International Protocol. METHODS: The blood pressure (BP) was measured at the same arm by two certified observers using two mercury columns and a double stethoscope, then by the volunteer with the automatic device, these measurements were done seven times sequentially using 33 volunteers. For the randomization of the patient, one ABPM measure was compared to the mean of three manual measures. Then, we had three ABPM measures and four manual measures. Each ABPM measure, being compared to two manual measures. Blood pressure readings and recordings were blinded. Position of the subjects was standardized. RESULTS: Phase 1: To pass phase 1, the device had to have at least 25 of the 45 measurements within 5 mmHg, 35 within 10 mmHg or 40 within 15 mmHg of the comparative observer measurements. The AGILIS monitor had 35 measurements lying within 5 mmHg, 42 within 10 mmHg and 45 within 15 mmHg for systolic BP (SBP), 35 within 5 mmHg, 44 within 10 mmHg and 45 within 15 mmHg for diastolic BP (DBP). It passed the criteria for SBP and DBP. Phase 2: To pass phase 2.1, a device must have at least 60 of 99 measurements within 5 mmHg, 75 within 10 mmHg and 90 within 15 mmHg of the comparative observer measurements, and in addition must also have either 65 within 5 mmHg and 80 within 10 mmHg, or 65 within 5 mmHg and 95 within 15 mmHg, or 80 within 10 mmHg and 95 within 15 mmHg. The AGILIS monitor had 78 measurements within 5 mmHg, 91 within 10 mmHg and 96 within 15 mmHg for SBP; and 70 measurements within 5 mmHg, 92 within 10 mmHg and 96 within 15 mmHg for DBP. It passed the criteria for SBP and DBP. For phase 2.2 using the AGILIS monitor, 27 subjects had at least two of the differences within 5 mmHg and none had any differences within 5 mmHg for SBP; 27 subjects had at least two of the differences within 5 mmHg and three subjects had no differences within 5 mmHg for DBP. The results are in concordance with the requested criteria for phase 2.2. CONCLUSION: Thus the AGILIS device fulfils the validation criteria of the international protocol.     

Validation of the Omron M5-I, R5-I and HEM-907 automated blood pressure monitors in elderly individuals according to the International Protocol of the European Society of Hypertension

OBJECTIVE: This study aimed at verifying the accuracy of three automated electronic oscillometric blood pressure measuring devices, namely Omron M5-I (home use upper arm monitor), R5-I (home use wrist monitor) and HEM-907 (professional use upper arm monitor) according to the European Society of Hypertension International Protocol in elderly individuals. METHODS: Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants (aged >or=75 years) using the mercury sphygmomanometer (two observers) and each of the tested devices (one supervisor). A standard adult cuff was always employed during the study because all participants had an arm circumference compatible with such a cuff. According to the European Society of Hypertension validation protocol 99 couples (three pairs per patient) of test device and reference blood pressure measurements were obtained during phase 1 (15 participants studied) and phase 2 (a further 18 participants) for each electronic monitor. RESULTS: All devices successfully passed the validation study with a mean (+/-SD) device-observer difference for systolic and diastolic blood pressure of 0.2+/-3.6/0.2+/-3.9 mmHg (Omron M5-I), -1.5+/-6.2/-0.7+/-3.7 mmHg (Omron R5-I), and 0.1+/-5.1/-1.9+/-4.2 mmHg (Omron HEM-907). SD of the mean difference was lower and thus the precision was better for diastolic than for systolic blood pressure, and for the Omron M5-I than for the other two devices. CONCLUSIONS: According to the results of the validation study based on the European Society of Hypertension International Protocol the Omron M5-I, R5-I, and HEM-907 may be recommended for clinical use in elderly individuals, without atrial fibrillation or frequent ectopic beats.