European Society Of Hypertension Protocol Research Articles

Validity Of The Ihealth-bp7 And Withings-bp800 Self-measurement Blood Pressure Monitors

Blood pressure (BP) control among treated people with hypertension remains poor. Home BP monitoring devices have led to their widespread adoption, and are now consistently utilized for the evaluation and management of hypertension. Classifying individual’s risk associated with BP should be monitored using accurate BP measurement devices. However, little is known about the validity of the newly developed iHealth-BP7 and Withings-BP800 devices. PURPOSE: The purpose of this study is to validate the wireless iHealth-BP7 and Withings-BP800 monitors according to the European Society of Hypertension (ESH) International Protocol revision 2010. METHODS: Data from 11 participants (31.6 ± 2.2 years) were initially examined according to the ESH International Protocol revision 2010 for the validation of BP measuring devices in adults. Participants were asked to sit and relax for 10-15 mins with legs uncrossed, and back supported prior to the test. In all participants, sequential left arm measurements were performed by two trained observers using a mercury sphygmomanometer and one supervisor using the device. Collected data were screened according to the ESH protocol for both systolic BP (SBP) and diastolic BP (DBP). ESH International Protocol requires 33 subjects, but currently only 11 subjects participated in this study. Thus, the adjusted criteria of the protocol were applied to establish the standard for the 11 subjects. RESULTS: The mean differences between the monitor and sphygmomanometer readings were -0.55±3.75 (SBP) and 0.54±3.62 (DBP) for iHealth-BP7 and 3.18±4.37 (SBP) and -0.35±5.42 (DBP) for Withings-BP800. The iHealth-BP7 monitor passed all of the modified requirements, however the Withings-BP800 did not meet the last phase of the modified criteria of the ESH international protocol. CONCLUSION: The iHealth-BP7 monitor is recommended as a valid home BP monitoring device, however the Withings-BP800 fails to meet the ESH criteria in this study potentially due to the small sample size. Since the ESH protocol requires 33 subjects, further study with additional participants is warranted to determine validation of both devices.

Validation of the Parama-Tech PS-501 Device for Office Blood Pressure Measurement According to the International Protocol

The PS-501 device (Parama-Tech, Fukuoka, Japan), an automated device for office blood pressure measurement based on the Korotkoff method and designed for professional use in clinical settings, was validated. Consecutive outpatients with hypertension and ≥30 years old at an outpatient hypertension clinic were recruited. According to the European Society of Hypertension protocol, 33 participants were included in the validation study (phase 1, n = 15; phase 2, n = 18). The cuff deflation rate can be selected manually from 2, 3, and 4 mm Hg/beat. The validation was performed with the device deflating at a rate of 2 mm Hg/beat. All blood pressure readings were measured on the left arm. The tested device passed all criteria for both systolic and diastolic blood pressure measurements. The mean (± standard deviation) differences in systolic and diastolic blood pressure between the tested device and the mean of observer readings were −1.9 ± 4.6 and −2.5 ± 2.9 mm Hg, respectively. The PS-501 device for office blood pressure measurement passed all the validation criteria of the European Society of Hypertension and can therefore be recommended for clinical use in an adult population.

Accuracy of Microlife WatchBP Office ABI monitor assessed according to the 2002 European Society of Hypertension protocol and the British Hypertension Society protocol

To determine the accuracy of the WatchBP Office ABI monitor for blood pressure measurement developed by the Microlife Company. The device accuracy was tested in 85 subjects with a mean age of 54 ± 19 years. Their systolic and diastolic blood pressure (SBP/DBP) at entry was 141 ± 30/86 ± 19 mmHg, and upper arm circumference was 28 ± 5 cm. Initially, the data from 33 participants were examined according to the 2002 version of the European Society of Hypertension (ESH) protocol. An additional 52 subjects were then enrolled to fulfill the requirements of the British Hypertension Society (BHS) protocol. In all participants, sequential same arm measurements were performed by two trained observers. The device passed all three phases of the ESH protocol for SBP and DBP. For the BHS protocol the device was graded A for both SBP and DBP. The A/A grade was achieved in the low blood pressure category (< 130/80 mmHg), the B/A grade in the medium category (130-160/80-100 mmHg) and the A/A grade in the high category (> 160/100 mmHg). Mean blood pressure difference between device and observers in the first 33 subjects was -0.9 ± 5.5 mmHg for SBP and -2.2 ± 4.5 mmHg for DBP and in the 85 participants it was -1.2 ± 6.5 mmHg and -2.3 ± 5.1, respectively. These data show that the Microlife WatchBP Office ABI monitor satisfied the recommended ESH accuracy levels and achieved A/A grade of the BHS protocol across a wide range of BP.

Accuracy of the Microlife large–extra large-sized cuff (32–52 cm) coupled to an automatic oscillometric device

To determine the accuracy of the large-extra large-sized (L-XL) cuff (32-52 cm) coupled to a Microlife WatchBP Office ABI blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The L-XL cuff tested in this study is designed to provide accurate blood pressure measurements in patients with large arms (arm circumference≥32 cm) over a wide range of arm circumferences using a single 145±1×320±1 mm bladder. The evaluation was made in 33 patients with a mean±standard deviation age of 53±17 years (range: 30-96 years). Their systolic blood pressure (SBP) was 142±21 mmHg (range: 110-180 mmHg), diastolic blood pressure (DBP) was 87±14 mmHg (range: 62-106 mmHg) and arm circumference was 36±5 cm (range: 32-50 cm). Blood pressure measurements were made in the sitting position. The L-XL cuff coupled to the WatchBP Office ABI passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences between device and observer were -1.3±5.1 mmHg for SBP and -1.8±5.8 mmHg for DBP. Similar device-observer differences were observed in patients divided into two subgroups according to whether their arm circumference was above or below the median in the group. These results indicate that the L-XL cuff coupled to the WatchBP Office ABI monitor provides accurate blood pressure readings in patients with large arms over a wide range of arm circumferences.

Validation of the FM-800 Ambulatory Blood Pressure Monitor According to the Association for the Advancement of Medical Instrumentation Criteria and the International Protocol

To validate the FM-800 device (Fukuda Denshi Co., Ltd., Tokyo, Japan) for ambulatory blood pressure monitoring (ABPM), this validation study was performed based on the European Society of Hypertension (ESH) protocol and the Association for the Advancement of Medical Instrumentation (AAMI) criteria. Thirty-three participants were included (15 in phase 1 and an additional 18 in phase 2) in the ESH protocol. The device was tested on 85 participants according to the AAMI criteria, which require a mean device-observers discrepancy within 5 ± 8 mmHg. The tested device passed all the criteria for both systolic blood pressure (SBP) and diastolic blood pressure (DBP), and for the Korotkoff and oscillometric methods according to the ESH protocol. The test device also fulfilled the AAMI accuracy criteria for the 85 participants; the mean ± SD of the SBP//DBP differences between the tested device and the mean of the observer readings were –1.1 ± 4.2//–0.8 ± 4.2 mmHg for the Korotkoff method and 2.3 ± 3.9//–2.3 ± 3.9 mmHg for the oscillometric method. The FM-800 device for ABPM passed all the validation criteria of the ESH and AAMI and can, therefore, be recommended for clinical use in an adult population.

Accuracy of the visomat handy wrist blood pressure measuring device according to the International Protocol

The objective of this study is to determine the accuracy of the UEBE visomat handy device for blood pressure measurement in the wrist of patients tested according to the requirements of the International Protocol of the European Society of Hypertension (ESH). Device evaluation was done in 33 patients whose age and blood pressure were within the intervals required by the ESH protocol. Their mean±standard deviation age was 53.8±16.5 years (range 30-86 years), systolic blood pressure (SBP) was 143.5±20.2 mmHg (range 110-180 mmHg), diastolic blood pressure (DBP) was 87.4±12.9 mmHg (range 68-110 mmHg), arm circumference was 29.0±3.7 cm (range 21-38 cm), and wrist circumference was 17.3±1.5 cm (range 14.0-21.0 cm). During the measurements, which were taken in a sitting position, the patient's wrist was kept extended at the heart level putting a support under the forearm. In total, 45 measurements were available for analysis in the first phase of the validation process, and 99 measurements in the second phase. The visomat handy device passed all three phases of the ESH protocol for SBP and DBP. Mean blood pressure differences for the visomat handy monitor (device-observer) were -2.0±8.1 mmHg for SBP and -0.9±4.1 mmHg for DBP. These data show that the UEBE visomat handy wrist monitor met the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Validação do esfigmomanômetro aneroide Missouri para medir pressão arterial em pacientes com câncer

Auscultatory mercury sphygmomanometers to measure blood pressure (BP) have been banned from health services because of risk of pollution and environmental accidents with mercury. Aneroid appliances could be an alternative. To validate the Missouri aneroid device for blood pressure measurement in cancer patients according to the protocol of the European Society of Hypertension (ESH). 33 patients hospitalized or under outpatient care at the Cancer Institute of the State of São Paulo, FMUSP, were evaluated. Three trained and blinded observers performed nine sequential blood pressure measurements interspersed with the mercury sphygmomanometers. The differences between the values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) of the test device with the mercury sphygmomanometer were classified according to the ESH protocol. The Missouri equipment underwent all three phases required by the ESH Protocol for SBP and DBP, and it was approved in all of the phases. The average difference between the test device and the mercury sphygmomanometer was 0.62 (SD = 4.53) and 0.06 (SD = 6.57) mmHg for SBP and DBP, respectively. No association was found between the differences in BP measurements with sex, age, body mass index and arm circumference and length. The results revealed that the aneroid Missouri device meets ESH accuracy recommendations for the measurement of SBP and DBP, and it can be used to replace the mercury sphygmomanometer.

Validation of the Microlife WatchBP O3 device for clinic, home, and ambulatory blood pressure measurement, according to the International Protocol

To determine the accuracy of the Microlife WatchBP O3 blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The WatchBP O3 is designed to provide clinic, ambulatory, and self blood pressure (BP) measurements. Device evaluation was performed in 33 participants with a mean +/- standard deviation age of 56.1+/-20.7 years (range 30-95 years). Their systolic BP (SBP) was 144.7+/-24.1 mmHg (range 90-180 mmHg), diastolic BP (DBP) was 86.8+/-18.3 mmHg (range 50-120 mmHg), and arm circumference was 28.1+/-2.9 cm (range 22.0-34.0 cm). Blood pressure measurements were performed in the sitting position. The WatchBP O3 passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences for the WatchBP O3 (device observer) were -1.7+/-6.9 mmHg for SBP and -1.1+/-4.3 mmHg for DBP. In conclusion, these results indicate that the Microlife WatchBP O3 monitor can be recommended for clinical use in the adult population.

Validation of the Visomat Comfort form device for home blood pressure measurement according to the International Protocol

To evaluate the accuracy of the UEBE Visomat Comfort form device for home blood pressure measurement tested following the recommendations of the International Protocol of the European Society of Hypertension. Device evaluation was performed in 33 participants with a mean +/- standard deviation age of 56.5+/-18.3 years (range 30-91 years). Their systolic blood pressure (SBP) was 143.6+/-25.3 mmHg (range 94-180 mmHg), diastolic blood pressure (DBP) was 88.8+/-15.4 mmHg (range 64-116 mmHg), and upper arm circumference was 30.2+/-3.2 cm (range 24.5-39.0 cm). BP measurements were performed in the sitting position. The Visomat Comfort form passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean BP differences for the Visomat Comfort form (device-observer) were -2.5+/-5.9 mmHg for SBP and -2.4+/-5.4 mmHg for DBP. Similar device-observer differences were observed in the participants divided into two subgroups according to whether their arm circumference was above or below the median in the group. In conclusion, these results indicate that the UEBE Visomat Comfort form monitor can be recommended for clinical use in the adult population over a wide range of arm circumferences.

Development and validation of a blinded hybrid device according to the European Hypertension Society protocol: Nissei DM-3000

Both automated and auscultatory blood pressure (BP) devices have their strengths and accuracy limitations. Hybrid devices, such as the Nissei DM-3000, are mercury free and provide both automated and auscultatory measurement modes. The aim of this study was to validate all measurement modes of the Nissei DM-3000 device according to the European Society of Hypertension (ESH) protocol, as well as to develop and validate a 'blinded' auscultatory measurement mode. Different measurement modes were developed and evaluated in separate studies. Nine sequential same-arm BP measurements were taken alternating between simultaneous mercury sphygmomanometer readings and the device. The latter seven measurements were analysed according to the requirements of the ESH protocol. All measurement modes of the device passed the ESH protocol. The blinded mode achieved the best results with a mean difference+/-s.d. of -0.1+/-2.6 and 0.04+/-2.4 mm Hg for systolic BP (SBP) and diastolic BP (DBP), respectively. The most accurate auscultatory measurement results were obtained with a deflation rate of 2.5 mm Hg s(-1) achieving a mean difference+/-s.d. of -0.6+/-4.4 (for SBP) and -1.4+/-2.8 mm Hg (for DBP). The automated mode achieved a mean difference+/-s.d. of -0.8+/-6.0 (SBP) and 0.8+/-4.8 mm Hg (DBP). The Nissei DM-3000 device is a suitable replacement for the mercury sphygmomanometer.

Accuracy of the BP A100 blood pressure measuring device coupled with a single cuff with standard-size bladder over a wide range of arm circumferences

The objective of this study was to determine the accuracy of the Microlife BP A100 blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The BP A100 model is designed to provide accurate blood pressure measurements over a wide range of arm circumferences using a single cuff with standard-size bladder. Device evaluation was performed on 33 patients with a mean +/- SD age of 59 +/- 19 years (range 30-89 years). Their systolic blood pressure (SBP) was 143 +/- 23 mmHg (range 108-180 mmHg), diastolic blood pressure (DBP) was 87 +/- 16 mmHg (range 60-108 mmHg), and arm circumference was 31 +/- 4 cm (range 22-42 cm). In nine patients, the arm circumference was at least 33 cm. Blood pressure measurements were performed in the sitting position. The BP A100 passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences between device and observer were -2.9 +/- 4.9 mmHg for SBP and -2.6 +/- 4.6 mmHg for DBP. Similar device-observer differences were observed in the patients divided into two subgroups according to whether their arm circumference was above or below the median in the group. In conclusion, the present results indicate that the Microlife BP A100 monitor coupled with a single cuff with standard size bladder provides accurate blood pressure readings over a wide range of arm circumferences.

Validation of the visomat comfort eco blood pressure measuring device according to the International Protocol

The objective of this study was to determine the accuracy of the UEBE visomat comfort eco blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The device evaluation was performed in 33 participants with a mean+/-SD age of 54.3+/-18.7 years (range 30-91 years). Their systolic blood pressure (SBP) was 144.0+/-23.7 mmHg (range 100-180 mmHg), diastolic blood pressure (DBP) was 86.2+/-14.4 mmHg (range 60-110 mmHg), and upper arm circumference was 29.4+/-2.8 cm (range 24.0-34.0 cm). Blood pressure measurements were performed in the sitting position. The visomat comfort eco passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences for the visomat comfort eco (device-observer) were -0.5+/-5.7 mmHg for SBP and -1.4+/-5.3 mmHg for DBP. In conclusion, the present results show that the UEBE visomat comfort eco monitor can be recommended for clinical use in the adult population.

Validation of a non-mercury digital auscultatory device according to the European Hypertension Society protocol: Rossmax Mandaus II

To assess the accuracy of the Rossmax Mandaus II for clinical use, according to the protocol of the European Society of Hypertension (ESH). Thirty-nine participants were recruited to fulfill the 33 participant requirement of the protocol. Nine sequential same-arm blood pressure readings were taken by trained observers alternating between simultaneous mercury sphygmomanometer readings and the device readings. The latter seven readings were analysed according to the protocol guidelines and the criteria of the Association for the Advancement of Medical Instrumentation. The device passed both phases of the ESH protocol. Out of 99 differences, 78 systolic (SBP) and 84 diastolic (DBP) differences were within 5 mmHg; all differences were within 10 and 15 mmHg for both SBP and DBP. In phase 2.2 for SBP and DBP, respectively, 28 of 33 and 31 of 33 participants had at least two out of their three differences within 5 mmHg. Only one participant was found to have all three differences greater than 5 mmHg for SBP and DBP, respectively. The device also fulfilled the criteria of the Association for the Advancement of Medical Instrumentation standard with a mean difference+/-SD of -2.5+/-3.4 mmHg (SBP) and -2.3+/-3.6 mmHg (DBP). The Rossmax Mandaus II is the first auscultatory device with a numeric digital display to pass the ESH protocol. It can be recommended for clinical use in an adult population.

Validation of the visocor HM40 wrist blood pressure measuring device according to the International Protocol

The objective of this study was to determine the accuracy of the UEBE visocor HM40 device for blood pressure measurement at the wrist, tested according to the requirements of the International Protocol of the European Society of Hypertension (ESH). Device evaluation was performed in 33 patients whose age and blood pressure were within the intervals required by the ESH protocol. Their mean +/- SD age was 53.2 +/- 15.5 years (range 30-85 years), systolic blood pressure (SBP) was 142.8 +/- 21.8 mmHg (range 108-178 mmHg), diastolic blood pressure (DBP) was 87.0 +/- 15.4 mmHg (range 62-112 mmHg), and wrist circumference was 18.7 +/- 2.7 cm (range 15.5-21.5 cm). During the measurements, which were performed in the supine position, the patient's wrist was kept extended at the heart level with a support under the forearm. In total, 45 measurements were available for analysis in the first phase of the validation process, and 99 measurements in the second phase. The visocor HM40 passed all three phases of the ESH protocol for SBP and DBP. Mean blood pressure differences for the visocor HM40 monitor (device-observer) were -2.0 +/- 5.0 mmHg for SBP and -1.7 +/- 5.3 mmHg for DBP, respectively. These data show that the UEBE visocor HM40 wrist monitor met the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

The Omron Elite 7300W home blood pressure monitor passes the European Society of Hypertension International Validation Protocol for women and men

To test the accuracy of the Omron Elite 7300W home blood pressure monitor using the European Society of Hypertension (ESH) Protocol. The device was tested using the European Society of Hypertension International Protocol in 33 women and then in 10 men to satisfy the ESH for both men and women. The average error in all participants was 1.2+/-5.2 (SD) [(range -10 to 17)/3.29+/-5.5 (-6 to 17)] mmHg. This is the first device to have been tested using the ESH protocol for the special population of women only. The additional testing of men in the standard ESH protocol enables the validation of this device specifically in women but also in men. However, as with all automatic devices, it is important to validate its accuracy in each individual patient who uses it and to monitor its accuracy intermittently in each individual patient. The Omron Elite 7300W home blood pressure monitor passed the ESH validation protocol and can be recommended for patient use.

Validation of Microlife BP W100 wrist device assessed according to the European Society of Hypertension and the British Hypertension Society protocols

The objective of this study was to determine the accuracy of the Microlife BP W100 device for blood pressure measurement. The device evaluations were performed in 85 participants, by using both the protocol of the European Society of Hypertension (ESH) and the protocol of the British Hypertension Society (BHS). Initially, the data from 33 participants were examined according to the ESH protocol. Furthermore, 52 participants were then enrolled to fulfill the BHS protocol requirements. In all participants, sequential same arm measurements were made by two trained observers. The device passed all three phases of the ESH protocol for systolic blood pressure (SBP) and diastolic blood pressure (DBP) and was graded A according to the criteria of the BHS protocol for both SBP and DBP. The A/A grade was achieved in low (<130/80 mmHg), medium (130-160/80-100 mmHg) and high (>160/100 mmHg) blood pressure categories. Mean blood pressure difference between BP W100 and observers in the 85 participants was 0.1+/-5.3 mmHg for SBP and 1.1+/-3.4 mmHg for DBP, and thus, the device also met the requirements of the Association for the Advancement of Medical Instrumentation. In conclusion, these data show that the Microlife BP W100 wrist monitor satisfied the recommended ESH accuracy levels and achieved A/A grade of the BHS protocol across a wide range of blood pressure.

The impact of pulse pressure on the accuracy of wrist blood pressure measurement

There is an increasing number of wrist blood pressure measurement devices that successfully passed the validation procedures of the British Hypertension Society (BHS) and the European Society of Hypertension (ESH). It remains unknown, however, whether pulse pressure as a marker of arterial stiffness and vascular ageing affects the accuracy of these devices. An ESH protocol validated wrist device was compared with the upper arm mercury sphygmomanometry in a study population (33 patients, 99 measurements) including a relevant number of subjects with pulse pressure >50 mm Hg (84.8%) and isolated systolic hypertension (27.3%). Mean systolic bias was 10.2 mm Hg with 95% limits of agreement of -13.1 and 33.6 mm Hg, mean diastolic bias was 4.8 mm Hg with limits of agreement of -11.0 and 20.7 mm Hg. The impact of body mass index, age, systolic blood pressure and pulse pressure on the absolute value of blood pressure bias was tested by stepwise multiple regression analysis. The systolic bias significantly depended on pulse pressure, whereas there was no significant effect of the independent variables on the diastolic bias. Separate correlation analysis showed a significant correlation between pulse pressure and both absolute systolic bias (Pearson r=0.48, P<0.001) and relative systolic bias (systolic bias divided by systolic blood pressure, Pearson r=0.29, P=0.003). Even well-validated wrist blood pressure devices can show a clinically relevant bias in patients with elevated pulse pressure. Increased arterial stiffness may impair the accuracy of oscillometric blood pressure measurement at the wrist.

Assessment of the validation of blood pressure monitors: a statistical reappraisal

Protocols to determine the accuracy of noninvasive blood pressure monitors have been published by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, and the European Society of Hypertension (ESH). We compared the statistical basis for each of these protocols. Although the Association for the Advancement of Medical Instrumentation and British Hypertension Society protocols require a minimum of 85 participants, the ESH protocol requires only 33 participants. The reduced sample size results in a reduction in statistical power from 98 to 70%, which brings into question the applicability of the ESH (International) protocol.

Validation of the OMRON M7 (HEM-780-E) blood pressure measuring device in a population requiring large cuff use according to the International Protocol of the European Society of Hypertension

A high percentage of hypertensive patients present an arm circumference of over 32 cm; the use of a large cuff is therefore recommended. Validation studies are usually performed in the general population using a standard-size cuff. The aim of this study was to assess the accuracy of the Omron M7 device in a population with an arm circumference ranging from 32 to 42 cm. A validation study was performed according to the International Protocol of the European Society of Hypertension. This 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 analysis is performed. For each participant, four blood-pressure measurements were performed simultaneously by two trained observers, using mercury sphygmomanometers fitted with a Y tube; the measurements alternated with three by the test device. The difference between the blood-pressure value given by the device and that obtained by the two observers (mean of the two observations) was calculated for each measure. The 99 pairs of blood-pressure differences were classified into three categories (<or=5, <or=10 and <or=15 mmHg). The number of differences in each category was compared with the number required by the European Society of Hypertension protocol. The Omron M7 device passed the first and the second phases of the validation process. The average differences between the two observers were 1.5+/-3.2 and -0.5+/-2.2 mmHg for systolic blood pressure and diastolic blood pressure, and those between the device and the mercury sphygmomanometer were -1.6+/-6.7 for systolic blood pressure and -0.12+/-4.0 mmHg for diastolic blood pressure Readings that differ by less than 5, 10 and 15 mmHg for systolic blood-pressure and diastolic blood-pressure values fulfill the recommendation criteria of the European Society of Hypertension protocol. The Omron M7 (HEM-780-E) device fulfilled the validation criteria of the international protocol in a population with an arm circumference ranging from 32 to 42 cm.

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

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. 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. 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. 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. The BPW810 passed all the phases of the international protocol for both systolic and diastolic blood pressure.