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Objective: To determine the accuracy of the KOROT P3 Accurate (previously InBody BPBIO480KV) monitor, an automated auscultatory blood pressure (BP) measuring device developed for professional use, in people with extra-large arms according to the ISO81060-2 2018 protocol., Methods: The KOROT P3 Accurate was tested in 37 subjects with upper-arm circumference ranging from >42 to 53 cm using a mercury sphygmomanometer coupled to a 20 × 40 cm tronco-conical cuff as the reference standard., Results: The mean BP difference between the device and the observers' reference measurements was 1.2 ± 2.0 mmHg for systolic BP and 1.0 ± 2.0 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Also criterion 2 was satisfied being the standard deviations ± 1.7 mmHg for systolic BP and ± 1.6 for diastolic BP, well below the maximum values required by the protocol (±6.84/6.87 mmHg). Scatterplots of device-reference systolic and diastolic BP differences showed similar accuracy across the range of participants' BP, arm circumference and upper-arm slant angle., Conclusions: These data show that the KOROT P3 Accurate monitor satisfied the ISO 81060-2:2018 standard requirements in a special population of people with extra-large arms ranging from >42 to 53 cm., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

To determine the accuracy of the Hingmed DBP-01P monitor for clinical automatic blood pressure (BP) measurement according to the International Organization for Standardization (ISO) 81060-2 2018 protocol. The DBP-01P was tested in 85 subjects from the general population (mean age, 69.9 years; 43 men) using a wide-range cuff for arm circumferences from 17 to 42 cm. The mean device-observer difference was 1.32 ± 3.18 mmHg for SBP and 0.78 ± 3.15 mmHg for DBP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Also, criterion 2 was satisfied with the SDs of the 85 participants being well below the maximum values required by the protocol (6.80 and 6.89 mmHg for SBP and DBP pressure, respectively). These data show that the Hingmed BP monitor DBP-01P satisfied the ISO 81060-2:2018 standard requirements for a general population across a wide range of arm sizes using a single wide-range cuff., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Recommendations about the dimensions of the reference cuff for device validations in people with arm size >42 cm are still unavailable. The aim of this study was to identify the criteria for an appropriate reference cuff for validation studies in people with upper arm circumference between 43 and 50 cm., Methods: In 20 adults with upper arm circumference between 43 and 50 cm (X-large group), 34 subjects with arm circumference between 37 and 42 cm and 78 subjects with arm circumference <37 cm cylindrical and tronco-conical cuffs were compared. In all participants, the pressure transmitted to the arm under the two cuffs was measured using a paper-thin pressure sensor., Results: In the X-large group, all participants had an arm slant angle <86.0°. In this group, the difference between the pressure detected on the arm surface with the sensor using the cylindrical versus the tronco-conical cuff (13.5 mmHg) was larger than in the group with an arm circumference of 37-to 42 cm and the group with a circumference <37 cm (3.7 and 0.6 mmHg, respectively, P  < 0.001 versus both). In the whole sample, the between-cuff pressure difference was proportional to the conical shape of the arm ( P  < 0.001)., Conclusions: These data suggest that in people with arm size between 43 and 50 cm the reference cuff for validation studies should have a conical shape with an 84-85° slant angle. To comply with current guidelines, an 18.5 × 37.0 cm bladder should be used which would allow proper cuffing in the large majority of subjects., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The objective of this study was to determine the accuracy of the oscillometric blood pressure measurement technology of the Novacor Diasys 3 (model number DIS-0001-00) blood pressure monitor, intended for ambulatory blood pressure measurement, when used with the recommended Standard (ACC-0213-00), Large (ACC-0214-00) and Paediatric (ACC-0215-00) cuffs., Methods: The Novacor Diasys 3 (model number DIS-0001-00) was evaluated according to the requirements of the AAMI/ANSI/ISO 81060-2:2013 standard, including an additional cardiac-stress study, a requirement for ambulatory blood pressure measurement devices. It was also validated according to the requirements of the European Society of Hypertension International Protocol revision 2010. The protocol requirements for all thee studies were followed precisely., Results: The Novacor Diasys 3 (model number DIS-0001-00) fulfilled all of the requirements for a pass in each of the three studies. In the primary AAMI/ANSI/ISO 81060-2:2013 study, the Criterion 1 errors were +3.9 mmHg ± 2.9 mmHg for SBP and +3.4 ± 2.5 mmHg for DBP., Conclusion: The Novacor Diasys 3 (model number DIS-0001-00), when used with the recommended cuffs, can be recommended for ambulatory blood pressure measurement in the adult population., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The objective of this study was to determine the accuracy of the auscultatory and oscillometric blood pressure (BP) measurement technologies of the Novacor Diasys 3 Plus (model number DIP-0001-00) BP monitor, intended for ambulatory BP measurement when used with the recommended Standard Plus (ACC-0210-00), Large Plus (ACC-0211-00) and Paediatric Plus (ACC-0212-00) cuffs., Methods: The auscultatory measurement technology Novacor Diasys 3 Plus (model number DIP-0001-00) was evaluated according to the requirements of the AAMI/ANSI/ISO 81060-2:2013 standard, including an additional cardiac-stress study, a requirement for ambulatory BP measurement devices. It was also validated according to the requirements of the European Society of Hypertension International Protocol revision 2010. The oscillometric measurement technology was compared to that of the Novacor Diasys 3 (model number DIS-0001-00) according to the equivalence requirements of MEDDEV 2.7/1 rev 4. The protocol requirements for all three studies and the equivalence were followed precisely., Results: The Novacor Diasys 3 Plus (model number DIP-0001-00) fulfilled all of the requirements for a pass in each of the three studies of the auscultatory measurement technology. In the primary AAMI/ANSI/ISO 81060-2:2013 study, the criterion 1 errors were + 3.6 ± 2.7 mmHg for SBP and + 3.0 ± 2.7 mmHg for DBP. It was also proven to be equivalent to the Novacor Diasys 3 (model number DIS-0001-00) with respect to the oscillometric measurement technology CONCLUSION: The Novacor Diasys 3 Plus (model number DIP-0001-00), when used with the recommended cuffs, can be recommended for ambulatory BP measurement in the adult population.

Objective: The aim of the study was to determine the accuracy of the Microlife WatchBP O3 monitor for ambulatory blood pressure (BP) measurement according to the new ISO81060-2 2018 protocol., Methods: The WatchBP O3 was first tested in 97 subjects from the general population (mean age, 71.3 years; 48 men) using four cuffs of different sizes. In a second study, 36 subjects (mean age, 72.9 years; 18 men) underwent stress testing on a cycle ergometer in order to increase their heart rate by 15% or more., Results: In the general population, the mean device-observer difference was 1.3 ± 3.2 mmHg for systolic BP and was 0.7 ± 3.2 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Also, criterion 2 was satisfied being the SDs of the 97 participants well below the maximum values required by the protocol (6.82 and 6.90 mmHg, respectively). During the ambulatory monitoring study, the average heart rate increase was 20.3% (range 15.4-28.9%). The mean device-observer difference was 1.5 ± 2.8 mmHg for systolic BP and was 1.7 ± 2.6 mmHg for diastolic BP. Also, these data were in agreement with criterion 1 of the protocol., Conclusions: These data show that the Microlife WatchBP O3 monitor satisfied the ISO 81060-2:2018 standard requirements for a general population across a wide range of arm sizes and that also the protocol criteria for validation of devices intended for ambulatory BP monitoring were fulfilled.

The objective of this study was to determine the accuracy of the Hingmed WBP-02A device for ambulatory blood pressure (BP) monitoring according to the International Protocol of the European Society of Hypertension (ESH-IP). Device evaluation was carried out in 33 patients. The mean age was 69.8±13.8 years, the mean systolic BP was 137.6±27.0 mmHg (range: 96-172), the mean diastolic BP was 86.7±20.1 mmHg (range: 48-124) and the mean arm circumference was 30.1±6.2 cm (range: 20-43). The protocol requirements were followed precisely. Four different cuffs, small, standard, large, and extra-large were used. The device comfortably passed all ESH-IP requirements, as 84 out of 99 device-observer systolic BP differences and 97 of 99 diastolic BP differences were within ±5 mmHg thereby fulfilling the standards of the protocol. Device-observer BP differences were unrelated to arm circumference. These data show that the Hingmed WBP-02A device for ambulatory BP monitoring met the requirements for validation by the ESH-IP and can be recommended for clinical use in the adult population.

The aim of this study was to determine the accuracy of the WatchBP Office ABI monitor for office blood pressure measurement over a wide range of arm circumferences using the ANSI/AAMI/ISO 81060-2:2013 protocol. The device accuracy was tested in 88 participants whose mean±SD age was 54.5±17.6 years, whose arm circumference was 30.6±8.3 cm (range: 15-46 cm), and whose entry blood pressure (BP) was 138.3±23.4 mmHg for systolic and 83.7±14.6 mmHg for diastolic BP. Four cuffs (small, standard, large, and extra-large) suitable for arm circumferences ranging from 14.0 to 52.0 cm were used. The mean device-observer difference in the 264 separate BP data pairs was 0.7±3.8 mmHg for systolic BP and was 0.0±3.7 mmHg for diastolic BP. These data were in agreement with criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤5±8 mmHg). Moreover, criterion 2 was satisfied, the mean±SD device-observer difference of the 88 participants being 0.7±3.1 and 0.0±3.2 mmHg, respectively, for systolic and diastolic BP. Good agreement between observer and device was present across the whole range of arm circumferences. These data show that the Microlife WatchBP Office ABI monitor satisfied the ANSI/AAMI/ISO 81060-2:2013 standard requirements across a wide range of arm sizes.

The aim of this study was to define the accuracy of UM-211, an automated oscillometric device for office use coupled to several cuffs for different arm sizes, according to the International Protocol of the European Society of Hypertension. The validation was performed in 33 individuals. Their mean age was 59.6±12.9 years, systolic blood pressure (BP) was 144.3±21.5 mmHg (range: 96-184 mmHg), diastolic BP was 86.8±18.5 mmHg (range: 48-124 mmHg), and arm circumference was 30.2±4.3 cm (range: 23-39 cm). Four sequential readings were taken by observers 1 and 2 using a double-headed stethoscope and a mercury sphygmomanometer, whereas three BP readings were taken by the supervisor using the test instrument. The differences between the readings provided by the device and the mean observer measurements were calculated. Therefore, each device measurement was compared with the previous and the next mean observer measurement. The validation results fulfilled all the 2010 European Society of Hypertension revision Protocol criteria for the general population and passed all validation grades. On average, the device overestimated systolic BP by 1.7±2.4 mmHg and diastolic BP by 1.7±2.5 mmHg. These data show that the UM-211 device coupled to several cuffs for different ranges of arm circumference met the requirements for validation according to the International Protocol and can be recommended for clinical use in the adult population. However, these results mainly apply to the use of the 22-32 and the 31-45 cm cuffs.

The aim of this study was to determine the accuracy of the A&D UM-201 device coupled to several cuffs for different arm sizes for office blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. Evaluation was carried out in 33 individuals. The mean age of the individuals was 59.3±13.2 years, systolic BP was 145.4±20.6 mmHg (range: 109-186 mmHg), diastolic BP was 87.3±18.0 mmHg (range: 50-124 mmHg), and arm circumference was 30.4±4.2 cm (range: 23-39 cm). The protocol requirements were followed precisely. The UM-201 monitor passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated systolic BP by 3.0±2.1 mmHg and diastolic BP by 2.6±2.0 mmHg. These data show that the A&D UM-201 device coupled to several cuffs for different ranges of arm circumference fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

The aim of this study was to determine the accuracy of the A&D BP UB-543 wrist device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. The A&D BP UB-543 monitor is provided with a correct position guidance (CPG) indicator that ensures the correct placement of the wrist at the heart level. Device evaluation was carried out in 33 patients with the CPG indicator on. The mean age of the patients was 53.1±16.4 years, the mean systolic BP was 141.8±25.1 mmHg (range 84 : 196), the mean diastolic BP was 88.2±14.5 mmHg (range 34 : 132), the mean arm circumference was 29.0±3.6 cm (range 21 : 38), and the mean wrist circumference was 17.5±1.4 cm (range 15 : 20). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 1.1±2.9 mmHg and underestimated diastolic BP by 0.1±3.0 mmHg. These data show that the A&D BP UB-543 wrist device used correctly with the CPG indicator on met the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population., (Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.)

The aim of this study was to determine the accuracy of the A&D BP UA-651 device coupled to a wide-range cuff for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. The device was evaluated in 33 patients. The mean age of the patients was 56.5±15.1 years. The mean systolic BP was 144.3±23.8 mmHg (range 88 : 196), the mean diastolic BP was 87.5±15.8 mmHg (range 38 : 132), and the mean arm circumference was 29.0±3.4 cm (range 22 : 36). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 0.7±3.4 mmHg and underestimated the diastolic BP by 0.8±3.6 mmHg. The measurement error was unrelated to the patient's arm circumference. These data show that the A&D BP UA-651 device coupled to a wide-range cuff fulfilled the requirements for validation by the International Protocol over a wide range of arm circumferences and can be recommended for clinical use in the adult population.

The objective of this study was to determine the accuracy of the Thermor BIOS BD215 device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension (ESH). Device evaluation was carried out in 33 patients. The mean age of the patients was 57.0 ± 15.0 years, the mean systolic BP was 142.0 ± 20.3 mmHg (range 100-177 mmHg), the mean diastolic BP was 88.0 ± 14.6 mmHg (range 48-123 mmHg), and the mean arm circumference was 28.0 ± 3.0 cm (range 24-33 cm). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 0.6 ± 4.2 mmHg and underestimated diastolic BP by -0.5 ± 3.2 mmHg. The device-observer discrepancies were unrelated to patients' clinical characteristics. These data show that the Thermor BIOS BD215 device fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

The objective of this study was to determine the accuracy of the A&D BP UA-651 device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. Device evaluation was carried out in 33 patients. The mean age of the patients was 48.3±15.5 years, the mean systolic BP was 138.3±24.9 mmHg (range 90-180), the mean diastolic BP was 88.3±13.8 mmHg (range 60-108), and the mean arm circumference was 28.6±3.4 cm (range 23-36). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device underestimated the systolic BP by 0.4±4.4 mmHg and diastolic BP by 1.3±3.5 mmHg. The device-observer discrepancies were unrelated to patients' clinical characteristics. These data show that the A&D BP UA-651 device fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Objective: The objective of this study was to determine the accuracy of the A&D BP UB-542 wrist device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension (ESH)., Methods: Device evaluation was carried out in 33 patients. The mean age was 50.9±10.1 years, the mean systolic BP was 141.6±22.8 mmHg (range 92 : 189), the mean diastolic BP was 89.2±11.4 mmHg (range 62 : 120), the mean arm circumference was 28.8±3.2 cm (range 23-35), and the mean wrist circumference was 17.1±1.4 cm (range 14-19.5). The protocol requirements were followed precisely., Results: The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 1.8±7.2 mmHg and diastolic BP by 1.6±5.7 mmHg., Conclusion: These data show that the A&D BP UB-542 wrist device met the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Objective: To validate the UEBE Visomat Double Comfort, an upper arm blood pressure monitor designed for self-measurement of blood pressure and for clinical use in a general population according to the European Society of Hypertension International Protocol revision 2010., Methods: The device is provided with two operational modalities, a microphonic mode and an oscillometric mode. In this study, the oscillometric modality was tested. Device evaluation was performed in 33 participants with a mean ± standard deviation age of 56.3 ± 20.0 years (range, 25-85 years). Their systolic blood pressure was 140.4 ± 27.7 mmHg, diastolic blood pressure was 86.8 ± 17.2 mmHg, and arm circumference was 29.3 ± 3.9 cm., Results: The protocol requirements were followed precisely. The device passed all of the requirements fulfilling the standards of the protocol. Mean blood pressure differences between device and observer were -0.9 ± 4.1 mmHg for systolic blood pressure and -0.1 ± 3.3 mmHg for diastolic blood pressure., Conclusion: As the Visomat Double Comfort in the oscillometric modality has achieved the required standards, it is recommended for clinical use in an adult population.