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    Validation of the UEBE Visomat Double Comfort upper arm blood pressure monitor, in oscillometric mode, for clinic use and self-measurement in a general population according to the European Society of Hypertension International Protocol, revision 2010.

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    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

    Validation of the Hingmed WBP-02A device for ambulatory blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010

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    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

    Rectangular cuffs may overestimate blood pressure in individuals with large conical arms.

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    OBJECTIVES: : Although the upper arm has the shape of a truncated cone, cylindrical cuffs and bladders are currently used for blood pressure (BP) measurement. The aim of this study was to ascertain whether cylindrical and tronco-conical cuffs provide different readings according to arm size and shape. DESIGN: : We studied 220 individuals with arm circumference ranging from 22 to 42.5 cm. Four different cylindrical and four different tronco-conical bladders of appropriate size were used. Sequential same-arm measurements were performed in triplicate by two observers using the two cuffs in a random order. In 100 individuals, the actual pressure transmitted to the arm surface by the two cuffs at the central point was also measured. RESULTS: : Upper arm shape was tronco-conical in all of the individuals. In a multiple regression, conicity was related to arm circumference (P < 0.001) and length (P = 0.001). Arm conicity and size were independently related to the between-cuff SBP (P = 0.001 and 0.002, respectively) and DBP (P = 0.001 and <0.001, respectively) discrepancies. In the group with arm circumference of 37.5-42.5 cm, the cylindrical cuff overestimated BP measured with the tronco-conical cuff by 2.0 ± 0.4/1.8 ± 0.3 mmHg (P = 0.001 and <0.001). In this group, 15% of individuals found hypertensive with the cylindrical cuff were normotensive when assessed with the conical cuff. Differences as great as 9.7/7.8 mmHg were found in individuals with large arms and slant angle equal to or less than 83°. CONCLUSION: : In obese people, the upper arm may have a pronounced tronco-conical shape and cylindrical cuffs may overestimate BP. Tronco-conical cuffs should be used for BP measurement in individuals with large arms

    Only troncoconical cuffs can provide accurate blood pressure measurements in people with severe obesity

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    Rectangular (cylindrical) cuffs and bladders are currently used for blood pressure (BP) measurement at the upper arm. However, large arms have a troncoconical shape, which make cylindrical cuffs potentially unsuitable. Aim of this study was to investigate the effect of the shape of the cuff on BP measurement in very obese participants

    Accuracy of the WatchBP office ABI device for office blood pressure measurement over a wide range of arm sizes

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    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
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