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 Health & Life HL868BA blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol

OBJECTIVE: This study aimed to evaluate the accuracy of the automated Health & Life oscillometric upper arm blood pressure monitor HL868BA for home blood pressure monitoring according to the European Society of Hypertension International Protocol for blood pressure measuring devices in adults. METHOD: Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese using a mercury sphygmomanometer (two observers) and the HL868BA device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and further 18 participants in phase 2 of the validation study. Data analysis was performed using the ESHIP Analyzer. RESULTS: The HL868BA device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 31/45, 42/45, and 44/45 measurements (required 25, 35, and 40, respectively), respectively. The device also achieved the targets for phase 2.1, with 68/99, 91/99, and 95/99 differences within 5, 10, and 15 mmHg, respectively, for systolic blood pressure, and with 71/99, 88/99, and 94/99 within 5, 10, and 15 mmHg, respectively, for diastolic blood pressure. In phase 2.2, 22 and 28 participants had at least two of the three device-observers differences within 5 mmHg (required >/=22) for systolic and diastolic blood pressure, respectively. CONCLUSION: The Health & Life upper arm blood pressure monitor HL868BA can be recommended for home use in adults.     

Performance of the UA-787 oscillometric blood pressure monitor according to the European Society of Hypertension protocol

OBJECTIVE: To determine the accuracy of the UA-787 oscillometric blood pressure monitor developed by the A&D Company. DESIGN: Evaluation of the UA-787 was performed using the new protocol of the European Society of Hypertension. The performance of the monitor was assessed in relation to the subjects' gender, age, skinfold thickness, arm circumference, body mass index and elasticity index of large (C1) and small (C2) arteries. METHODS: The UA-787 monitor was assessed according to European Society of Hypertension requirements, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg, or more. In all subjects (n=33), indices of large-artery elasticity (C1) and small-artery elasticity (C2) were measured with the HDI/Pulsewave CR-2000 Research Cardiovascular Profiling System. RESULTS: The UA-787 passed all three phases of the protocol for both systolic and diastolic blood pressure. The mean blood pressure difference between device and the observers was 1.0+/-5.3 mmHg for systolic pressure, and 0.7+/-5.3 mmHg for diastolic pressure. In univariate analysis, the discrepancy between device and the observers was related to forearm circumference (P=0.02) for systolic pressure. For diastolic blood pressure, a significant relationship was found only for heart rate (P<0.01). However, in a multivariable regression analysis no clinical variable was an independent predictor of device-observer discrepancy. In particular, the performance of the UA-787 appeared to be uniform across the whole range of C1 and C2. CONCLUSIONS: These data show that the A&D UA-787 device satisfies the new recommended European Society of Hypertension accuracy levels for both systolic and diastolic pressure. Its performance is uniform across sub-groups of subjects with different clinical characteristics.     

Validation of the Microlife BP 3BTO-A oscillometric blood pressure monitoring device according to a modified British Hypertension Society protocol

BACKGROUND: The market for devices for the self-measurement of blood pressure is growing, and as accuracy is of prime importance, there is increasing pressure for manufacturers to provide evidence of independent testing. Recent reviews have shown that only five automated upper arm devices for self-measurement of blood pressure have been recommended for use. We tested the Microlife BP 3BTO-A, a lightweight, upper arm, automated oscillometric device, according to a modified version of the British Hypertension Society protocol and also analysed the computer-generated oscillograms for possible causes of inaccuracy. METHODS: One hundred and twenty-six subjects were recruited from general medical and specialist clinics and from amongst the staff at Guy's and St Thomas' Hospital, London, UK. Only 85 of these were included in the final analysis. Nine sequential readings were taken by two trained observers alternating between the mercury sphygmomanometer and the device. The last seven readings were analysed according to the British Hypertension Society protocol. Modifications to the protocol were: (1) the exclusion of patients whose blood pressure varied by more than 15 mmHg between sequential observer readings and (2) limited testing in the low systolic pressure range. RESULTS: The Microlife achieved a grade A for both systolic and diastolic pressure according to the British Hypertension Society protocol. The mean differences (standard deviation) between the observers and the device were -1.6 (7.7) mmHg and -2.1 (6.3) mmHg for systolic and diastolic blood pressure, respectively, therefore also fulfilling the criteria set by the Association for the Advancement of Medical Instrumentation. Sub-analysis for different pressure ranges showed that the device was less accurate in the high-pressure range (>160/100 mmHg). CONCLUSION: The Microlife can be recommended for clinical use in an adult population.     

Validation of the Oregon scientific BPW810 blood pressure monitor according to the European Society of Hypertension Protocol

OBJECTIVE: To determine the accuracy of the BPW810 blood pressure monitor developed by IDT Technology Limited, according to the international protocol of the European Society of Hypertension. DESIGN: The international protocol is divided into two phases: the first phase is performed on 15 selected participants and, if the device passes this phase, 18 more participants are included making a total of 33 participants on whom the final validation is performed. METHOD: According to the European Society of Hypertension requirements, for each of the 33 participants, four blood pressure measurements were taken simultaneously by two trained observers, using mercury sphygmomanometers alternately with three measurements by the test device. The difference between the blood pressure value given by the device and mean of the two observers' readings was calculated for each measurement. The 99 differences were classified into zones (< or =5, < or =10, and < or =15 mmHg). The number of differences in each zone was compared with the number required by the international protocol. Furthermore, an individual analysis was then done to determine for each participant the number of comparisons < or =5 mmHg, which requires that at least 22 of the 33 participants should have two of three comparisons < or =5 mmHg. RESULTS: The BPW810 passed the first phase of the validation process for systolic and diastolic blood pressure. For the second phase, the difference between the device and mean of two observers was -2.2+/-4.8 mmHg for systolic blood pressure and -0.5+/-3.7 mmHg for diastolic blood pressure. In the last phase, 26 participants fell in the zone of two of the three comparisons lying within 5 mmHg and none of the participants fell in the zone of all three of the comparisons over 5 mmHg apart. CONCLUSION: The BPW810 passed all the phases of the international protocol for both systolic and diastolic blood pressure.     

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.     

Self-measurement of blood pressure: validation of the Braun BP VitalScan Plus 1650 monitor according to the European Society of Hypertension International Protocol

BACKGROUND: Self-measurement of blood pressure (BP) has been increasingly encouraged as a supplement to measurements in the clinic. OBJECTIVE: The main objective of this study is to clinically evaluate a new device for self-measurement of BP according to the International Protocol of the European Society of Hypertension (2002). METHODS: Measurements of systolic and diastolic BP in 33 volunteers (15 for phase 1 and a further 18 for phase 2 providing 99 measurements) were obtained using the mercury sphygmomanometer (HgS; Baumanometer) and the Braun BP VitalScan Plus 1650 device. Nine sequential same-arm measurements between the test device and the standard HgS were carried out according to the International Protocol of the European Society of Hypertension in two phases (phase 1, phase 2.1 and phase 2.2). RESULTS: The device passed phase 1 as 30 systolic and 33 diastolic readings fell within 5 mmHg exceeding the 25 required. In addition, the equipment also passed phase 2.1 as 74 systolic and 77 diastolic readings fell within 5 mmHg exceeding the 65 required for being approved. Finally, it also passed the phase 2.2 as 25 volunteers for systolic and 28 for diastolic had at least 2/3 of their comparisons falling within 5 mmHg (exceeding the 22 required) and only two of the 33 volunteers had their three comparisons over 5 mmHg apart (at the most three are required). The difference-against-mean plots showed that the disagreement between the HgS and the device was -2.57+/-4.36 mmHg for systolic BP and +0.83+/-4.97 mmHg for diastolic BP, respectively. CONCLUSION: The equipment passed the different phases satisfactorily and the study suggests that it can be used for self-BP monitoring. The device, however, needs to be used with care by the patients following the instructions, because even when it may be accurate in a laboratory setting, there is potential for them to be used inaccurately in the home setting.     

Self-monitoring of ambulatory blood pressure by the Microlife WatchBP O3--an application test

Ambulatory blood pressure monitoring (ABPM) is not widely used in clinical practice, because the measuring procedure is complex and the devices are expensive and need to be fitted by skilled medical technologists. The Microlife WatchBP O3 (Microlife AG, Widnau, Switzerland), which was developed for self blood pressure monitoring at home and adapted for ABPM, is highly affordable for an ABPM device and easy to manipulate. We performed an application test of the WatchBP O3 to confirm reliability of the device. Thirty-seven volunteer participants (age 30.4 ± 13.5 y) underwent blood pressure (BP) measurements every 30 min for 24 h, and were asked to complete a questionnaire about the user-friendliness and acceptability of the device. The participants were asked to attach the device and to detach it the next morning by themselves. The quality of recordings was assessed in terms of percentage of valid readings. The mean number of 24-h BP readings per participant was 46.6 ± 5.3. The percentage of valid readings was 90%, which was similar to that reported for traditional ambulatory devices. Eighty-six percent of participants found it is "easy" or "very easy" to attach the device by themselves. The WatchBP O3, which is easy to manipulate, may be convenient and acceptable for users. The percentage of valid readings is similar to that reported previously. A new era of self-monitoring of ambulatory BP is anticipated in the near future.     

Validation of the Artsana CSI 610 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension

BACKGROUND: There is evidence that blood pressure measurement outside the doctor's office can provide valuable information for the diagnostic evaluation of hypertensive patients and for monitoring their response to treatment. Home blood pressure monitoring devices have a major role in this setting, provided that their accuracy in measuring blood pressure is demonstrated by validation studies. OBJECTIVE: This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device Artsana CSI 610 complied with the standard of accuracy indicated by the ESH International Protocol. METHODS: Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always employed during the study. According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants). RESULTS: The Artsana CSI 610 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg and never <40 within 10 and 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -1.4+/-4.8 mmHg for systolic and -0.9+/-3.5 mmHg for diastolic blood pressure. CONCLUSIONS: According to the results of the validation study on the basis of the ESH International Protocol, the Artsana CSI 610 can be recommended for clinical use in adults.     

Validation of the Artsana CS 410 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension

BACKGROUND: Electronic blood pressure monitoring devices are widely used by patients for monitoring their blood pressure at home. Few of them, however, have been validated against recognized protocols and proved to be accurate. OBJECTIVE: This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device, Artsana CS 410 (Artsana S.p.A., Grandate, Como, Italy), complied with the standard of accuracy indicated by the European Society of Hypertension (ESH) International Protocol. METHODS: Sequential measurements of systolic and diastolic blood pressure were obtained in 33 patients (13 males, 20 females, mean age+/-SD 49+/-12 years) using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always used during the study. According to the ESH validation protocol, 99 pairs of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs of measurements for each of the 33 patients). RESULTS: The Artsana CS 410 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg, never <40 within 10 mmHg and never <42 within 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -0.9+/-5.9 mmHg for systolic and -1.0+/-3.1 mmHg for diastolic blood pressure. CONCLUSION: According to the results of the validation study, based on the ESH International Protocol, the Artsana CS 410 may be recommended for clinical use in adults.