Validation of B.Well PRO-33 oscillometric blood pressure monitor for professional office use in the general population in accordance with Amendment 2 of the Standard 81060-2:2018 by the International Organization for Standardization (ISO 81060-2:2018/AMD 2:2024).

To evaluate the accuracy of the EDAN SA-10 oscillometric upper-arm professional office ambulatory blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension (ESH)/International Organization for Standardization (ISO) Universal Standard (ISO 81060-2:2018). Subjects were recruited according to the AAMI/ESH/ISO Universal Standard using the same arm sequential BP measurement method. Four cuffs of the test device were used for arm circumference 16-21.5 cm (extra small), 20.5-28 cm (small), 27-35 cm (medium), and 34-43 cm (large). A total of 105 subjects were recruited, and 97 subjects were included in the final analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -0.59 ± 4.04/-1.79 ± 4.39 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 3.10/3.80 mmHg (systolic/diastolic). The EDAN SA-10 upper-arm ambulatory BP monitor has passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

The aim of this study was to evaluate the accuracy of the InBody BPBIO250 oscillometric upper-arm professional office blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Subjects were recruited to fulfil the age, gender, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large). Ninety-seven subjects were recruited and 88 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.9 ± 5.9/0.9 ± 4.9 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 4.78/4.31 mmHg (systolic/diastolic). The InBody BPBIO250 professional oscillometric device for office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol. The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer's instructions. In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was -2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤5±≤8 mmHg. The mean differences between the two observers and Omron HEM-1026 were -2.1 ± 5.71 mmHg for systolic BP and -0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled. The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.

To evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure (BP) monitor in general population (for clinic and home BP measurements in adults) according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2 : 2018) and its Amendment 1. 2020. Subjects were recruited to fulfill the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumferences 22-32 cm (standard) and 22-45 cm (wide range). Ninety-two subjects were recruited and 85 subjects were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.3 ± 7.2/2.2 ± 5.5 mmHg (systolic/diastolic). For validation criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 6.1/4.8 mmHg (systolic/diastolic). The YuWell YE660D oscillometric upper-arm electronic BP monitor has passed the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its Amendment 1. 2020 in adults and hence can be recommended for home and clinical use.

The performance of the Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018 (E) and amendment (Amd)1:2020 protocol. The device was used to assess 98 participants who fulfilled the inclusion criteria, including the range of arm circumference and systolic and diastolic BP, in accordance with the protocol. Data validation and analysis were performed according to the manufacturer's instructions. In the ISO validation procedure (criterion 1), the mean ± SD of the differences between test device readings and reference BP was 0.3 ± 6.17/3.6 ± 5.26 mmHg (systolic/diastolic). These data fulfilled the ISO requirements of ≤5±≤8 mmHg. The mean differences between the observer measurements and Omron HEM-7372T1-AZAZ (BP5460) readings were 0.3 ± 4.82 mmHg for systolic BP and 3.6 ± 4.78 mmHg for diastolic BP, fulfilling criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP. Therefore, two ISO criteria were fulfilled. The Omron HEM-7372T1-AZAZ BP monitor fulfilled the requirements of the ISO validation standard. This device can be recommended for home BP measurements in the general population.

ABSTRACTThe aim of this study was to evaluate the accuracy of the single upper‐arm cuff oscillometric blood pressure (BP) monitor RBP‐9000 c developed for office and home blood pressure measurement in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060–2:2018). Subjects were recruited to fulfill the age, gender, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in the general population using the same‐arm sequential BP measurement method. The test device incorporates a single built‐in cuff suitable for 17–42 cm arm circumference. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 2.4 ± 6.7/3.3 ± 6.3 mmHg (systolic/ diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.28/5.32 mmHg (systolic/diastolic). The RBP‐9000c oscillometric device for office and home BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018) in the general population and can be recommended for clinical and self‐use at home.Trial Registration: ChiCTR2300075747

The aim of this study was to evaluate the accuracy of the single upper‐arm cuff oscillometric blood pressure (BP) monitor RBP‐9801 developed for office and home BP measurement in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060–2:2018). Subjects were recruited to fulfil the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. A total of 105 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 2.3 ± 6.4/3.1 ± 5.8 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.24/5.03 mmHg (systolic/diastolic). The conclusion is that the RBP‐9801 oscillometric device for office and home BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018) in the general population and can be recommended for clinic and self‐use at home.

Out-of-office blood pressure measurement in children and adolescents

The objective of this study is to evaluate the accuracy of the iHealth BP7 wrist blood pressure (BP) monitor for clinical use and self-measurement in general population according to the International Organization for Standardization (ISO) 81060-2:2018/Amendment (Amd) 1:2020 protocol. Same arm BP was sequentially measured in 95 qualified participants and compared with a standard mercury sphygmomanometer. A total of 285 comparison pairs were obtained and analyzed according to the ISO 81060-2:2018/Amd 1:2020. For the validation Criterion 1 of the protocol, the mean ± SD of the differences between the test device and reference BP readings was 0.62 ± 6.18 and -0.20 ± 5.59 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged BP differences between the test device and reference BP per subject were 5.79 and 5.28 mmHg (with maximum allowed SDs of 6.90 and 6.95 mmHg) for SBP and DBP, respectively. The iHealth BP7 wrist BP monitor satisfied all the validation requirements according to the ISO 81060-2:2018/Amd 1:2020 protocol and can be recommended for clinical use and self-measurement in the general population.

To evaluate the accuracy of the InBody BPBIO210 manual auscultatory mercury-free hybrid blood pressure (BP) measuring device for professional office use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Subjects were recruited to fulfil the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large). A total of 94 subjects were recruited and 86 were analysed (mean age 53.7 ± 18.4 [SD] years, 50 men, arm circumference 32.5 ± 4.8 cm, range 22-42 cm). For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -1.0 ± 4.1/-0.7 ± 2.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 2.65/1.59 mmHg (systolic/diastolic). The InBody BPBIO210 manual auscultatory hybrid device for professional office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use.

Automated cuff blood pressure (BP) devices are widely used for ambulatory, home, and office BP measurement. However, an automated device, which is accurate in the general adult population may be inaccurate in some special populations. A 2018 Collaborative Statement by the US Association for the Advancement of Medical Instrumentation, the European Society of Hypertension, and the International Organization for Standardization (ISO) considered three special populations requiring separate validation (age <3 years, pregnancy, and atrial fibrillation). An ISO Task Group was appointed to identify evidence for additional special populations. Evidence on potential special populations was identified from the STRIDE BP database, which performs systematic PubMed searches for published validation studies of automated cuff BP monitors. Devices that passed in a general population, but failed in potential special populations were identified. Of 338 publications (549 validations, 348 devices) in the STRIDE BP database, 29 publications (38 validations, 25 devices) involved 4 potential special populations: (i) age 12-18 years: 3 of 7 devices failed but passed in a general population; (ii) age more than 65 years: 1 of 11 devices failed but passed in a general population; (iii) diabetes type-2: 4 devices (all passed); (iv) chronic kidney disease: 2 of 7 devices failed but passed in a general population. Some evidence suggest that the automated cuff BP devices may have different accuracy in adolescents and in patients with chronic kidney disease than in the general population. More research is needed to confirm these findings and investigate other potential special populations.

we assessed the accuracy of the QMon-20 oscillometric upper-arm cuff device professional for office blood pressure (BP) in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Subjects were recruited according to AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-31 (medium) and 32-42 cm (large). One-hundred and fourteen subjects were recruited and 106 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.8 ± 5.4/-0.5 ± 4.2 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 4.34/3.48 mmHg (systolic/diastolic). The QMon-20 oscillometric device for office BPs measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

To evaluate the accuracy of the AViTA oscillometric upper arm home blood pressure (BP) monitor in adult and pregnant populations according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/ International Organization for Standardization (ANSI/AAMI/ISO) Universal Standard (ISO 81060-2:2013). BP measurements on the upper arm were performed on 85 adult subjects and 46 pregnant subjects. The AViTA BPM636 and a standard mercury reference sphygmomanometer were applied and followed the same arm sequential BP measurement method. The universal cuff of the test device was used for arm circumference of 22-42 cm. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.1 ± 5.49/2.9 ± 5.17 mmHg (systolic/diastolic) for adults; and -2.2 ± 5.93/1.5 ± 4.92 mmHg (systolic/diastolic) for pregnant women. For criterion 2, the SD of the averaged BP differences between the test device and reference BP per adult subject was 4.45/4.20 mmHg (systolic/diastolic) and per pregnant women was 4.66/3.96. The AViTA BPM636 had passed the criteria of the ANSI/AAMI/ISO 81060-2:2013 protocol and can be recommended for home BP measurements in adults and pregnant populations.

The aim of this study was to evaluate the accuracy of the CONTEC08A oscillometric upper-arm blood pressure (BP) monitor for BP measurement in adults according to the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd)1:2020 standard. Eighty-five subjects (male 40 and female 45) were recruited to fulfill the age, sex, BP, and cuff distribution criteria of the ISO standard in the general population, and had a mean age of 40.2 years. The same arm sequential BP measurement method was used with three differently sized cuffs for the arm circumference ranging from 18 to 26 cm (small), 22-32 cm (medium), and 22-43 cm (large), respectively, for the test device, and two differently sized cuffs for the arm circumference ≤32 cm (standard) and >32 cm (large), respectively, for the mercury sphygmomanometer. Two hundred and fifty-five comparison pairs were obtained for analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference SBP/DBP readings was 1.1 ± 6.7/3.0 ± 5.3 mmHg. For validation criterion 2, the SD of the averaged SBP/DBP differences between the test device and reference BP per subject was 5.63/4.68 mmHg. The automated upper-arm BP monitor CONTEC08A has passed the requirements of the ISO Universal Standard in the general population, and can be recommended for BP measurement in adults.

To the Editor: We read with interest the paper by Sega et al regarding the prognostic value of ambulatory, home, and office blood pressure in the PAMELA population.1 However, we find that the main conclusions of the report may be driven by the lack of adjustment for confounders. The relationships between level of blood pressure and risk were not adjusted for age, which may have a major influence on risk over a long time span. There is indeed a relation between age and blood pressure,2 and therefore, these results may be biased. The comparisons of the various blood pressures were also not adjusted for potential confounders, with the argument that “no adjustment for age, sex, and other cardiovascular risk factors was made because comparisons between the predictive value of various blood pressure values involved the same sample.” However, it has been shown in a general Belgian population that the within-subject differences between office and ambulatory blood pressure measurements increased with older age and greater body mass index.3 In addition, in the Danish MONICA population, the within-subject differences between office and ambulatory blood pressure measurements increased with older age, diagnosis of hypertension, male gender, and presence of diabetes.4 So, to assess the true prognostic value of office blood pressure versus that of ambulatory blood pressure, it is mandatory to explore whether adjustments for other relevant cardiovascular risk factors would change the results. Recently, it was shown in the Danish MONICA population that ambulatory blood pressure was a much better predictor of all-cause mortality and cardiovascular mortality than office blood pressure, taking other relevant risk factors into account.5 Accordingly, to make the results from previous studies comparable to the PAMELA study, we would like to know the results of adjusted analyses. Until that time, the conclusion that …