Validation of the CONTEC08C oscillometric blood pressure monitor in adults according to the International Organization for Standardization 81060-2:2018 standard.

This study aimed to validate the accuracy of the test device (TMB-2296-BT) blood pressure (BP) monitor in adults according to International Standard Organization (ISO) 81060-2:2018 + Amd.1:2020 universal standard protocol, which is a digital monitor. Three trained observers used the same arm sequential method to compare the SBPs and DBPs measured by the test device with those measured by the reference device (mercury sphygmomanometer). For the test device with cuff ranging from 22 to 32 cm, there are 88 adults, with a male-to-female ratio of 35 : 53. The mean difference and SD between reference BPs and test device BPs readings were (0.21 ± 2.59)/(0.66 ± 2.12) mmHg for SBP/DBP for criterion 1, and (0.21 ± 2.07)/(0.66 ± 1.76) mmHg for SBP/DBP for criterion 2. For the test device with cuffs ranging from 22 to 42 cm, there are 87 adults, with a male-to-female ratio of 49 : 38. The mean difference and SD between reference BPs and test device BPs readings were (-1.62 ± 2.80)/(0.12 ± 3.01) mmHg for SBP/DBP for criterion 1, and (-1.62 ± 2.35)/(0.12 ± 2.60) mmHg for SBP/ DBP for criterion 2. And for the test device with cuff arm circumference sizes of 22-32 cm and 22-42 cm fulfilled both validation criterion 1 and 2 of the ISO 81060-2:2018 + Amd.1:2020 standard and can be recommended for both clinical and self/home BP measurement in adults.

To assess the accuracy of the iHealth oscillometric ambulatory blood pressure (BP) monitor in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard. Adults were recruited to fulfil the age, sex, BP and cuff distribution criteria of the ANSI/AAMI/ISO standard using the same-arm sequential BP measurement method. Two cuffs of the test device were used for arm circumferences 22-34 and 30-42 cm. A total of 100 individuals were recruited and 85 were included in the analysis. For validation criterion 1, the mean±SD of the differences between the test device and reference BP was -0.7±6.0/0.7±4.8 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference per participant was 4.72/3.97 mmHg (systolic/diastolic). The iHealth ambulatory BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard in adults and can be recommended for clinical use.

To evaluate the accuracy of the Rossmax AC1000f oscillometric upper-arm blood pressure monitor in adults according to the British Hypertension Society Protocol. Eighty-five subjects (male 42 and female 43) with a mean age of 48.1 years were recruited to fulfill the blood pressure distribution criteria of the British Hypertension Society Protocol in general population using the same arm sequential blood pressure measurement method. For each subject, we sequentially measured blood pressure using a mercury sphygmomanometer (two observers) and the AC1000f device (one supervisor). Data analysis was carried out according to the British Hypertension Society Protocol. A total of 255 comparison pairs were obtained for analysis. The device achieved grade A. The percentage of blood pressure differences within 5, 10 and 15 mmHg was 66.7, 92.2 and 98.0%, respectively, for SBP, and 64.7, 90.2 and 98.4%, respectively, for DBP. The average (±SD) of the device-observer differences was -0.5 ± 6.0 mmHg for SBP and -1.4 ± 5.9 mmHg for DBP, respectively. The automated upper-arm blood pressure monitor Rossmax AC1000f has passed the requirements of the British Hypertension Society Protocol, and hence can be recommended for blood pressure measurement in adults.

To evaluate the accuracy of the YuWell YE900 oscillometric upper-arm professional office blood pressure monitor in adults and children 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, sex, blood pressure and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in adults and children (aged 3-12 years) using the same arm sequential blood pressure measurement method. Three cuffs of the test device were used for arm circumference 18-22 cm (small), 22-32 cm (medium) and 32-42 cm (large). Ninety-two subjects were recruited, and 85 (50 adults and 35 children) were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was 1.7 ± 6.62/3.1 ± 5.76 mmHg (systolic/diastolic). For validation criterion 2, the SD of the averaged blood pressure differences between the test device and reference blood pressure per subject was 5.25/5.13 mmHg (systolic/diastolic). The YuWell YE900 professional electronic blood pressure monitor has passed the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in adults and children 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.

This study aimed to validate the accuracy of DBP-6279B, an automated inflationary oscillometric upper-arm blood pressure (BP) monitor, in the sitting position according to the AAMI/ESH/ISO (81060-2 : 2018 + Amd.1 : 2020) universal standard protocol. SBPs and DBPs were measured simultaneously on the same arm in 88 adults (female : male = 47 : 41) with a mean age of 56.85 years using a mercury sphygmomanometer (two observers) and a DBP-6279B device (one supervisor). The AAMI/ESH/ISO 81060-2 : 2018 and Amd.1 : 2020 universal standards for the validation of BP-measuring devices in adults and adolescents were followed. A total of 259 valid pairs of data were used in the analysis. According to Criterion 1, the mean difference of SBP between the test device (DBP-6279B) and the reference device (the mercury sphygmomanometer) was 0.75 mmHg, with a SD of 7.66 mmHg. The mean difference in DBP was 1.13 mmHg, with a SD of 6.14 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, the mean difference of SBP between the test device and the reference device was 0.85 mmHg, and the SD was 6.56 mmHg, which was less than 6.88 mmHg and met the requirements. The mean difference in DBP was 1.27 mmHg, and the SD was 5.42 mmHg, which was less than 6.82 mmHg and met the requirements. DBP-6279B fulfilled the requirements of the AAMI/ESH/ISO universal standard (ISO 81060-2 : 2018 + Amd.1 : 2020); hence, it can be recommended for both clinical and self/home BP measurement in adults and adolescents.

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.

Accurate measurement of blood pressure (BP) is crucial for the diagnosis and ongoing management of hypertension. Only devices that have been validated using an established protocol should be used to measure BP. The aim of this study was to validate the Microlife BP3T01-1B, an automated upper-arm BP measuring device, according to the DIN EN ISO 81060-2:2018-11 (ANSI/AAMI/ISO 81060-2:2018) standard protocol. BP measurements were performed in 85 adults and adolescents (age range: 13-86 years) using the same-arm sequential method of the DIN EN ISO 81060-2:2018-11 protocol, alternating between the test device and a reference mercury sphygmomanometer. A total of 255 valid comparisons were available for the analysis of criterion 1. The mean ± SD difference between the test device and the reference device values was -2.56 ± 7.53 mmHg for SBP and -3.10 ± 5.65 mmHg for DBP. The mean differences met the pass criterion of less than or equal to ±5 mmHg and the SD values met the pass criterion of ≤8 mmHg. All 85 participants were included in the analysis of criterion 2. The mean ± SD intraindividual difference between the test and reference devices was -2.56 ± 6.15 mmHg for SBP and -3.10 ± 4.85 mmHg for DBP. Both were within the required pass range of SD ≤6.43 mmHg for SBP and SD ≤6.20 mmHg for DBP. The Microlife BP3T01-1B BP monitoring device fulfilled the criteria of the DIN EN ISO 81060-2:2018-11 (ANSI/AAMI/ISO 81060-2:2018) protocol in a general population and can be recommended for the measurement of BP in adults and adolescents.

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.

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

Aim of this study was to validate the Microlife BP B3 AFIB/enterprise resource planning (ERP) No: BP3KT1-3 N blood pressure (BP) monitor according to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) 81060-2:2019 in adolescents and adults from a general population. BP measurements on the upper arm were performed in 85 subjects (age range 12-88 years), using the Microlife BP B3 AFIB and a standard mercury reference sphygmomanometer. A total of 255 valid BP comparisons were performed for the present validation analysis. The mean ± SD difference between the test and the reference device was 0.70 ± 7.05 mmHg for SBP (pass criterion ≤5 mmHg) and -0.85 ± 4.70 mmHg for DBP (pass criterion ≤5 mmHg) with the SD below the required value of ≤8 mmHg. The mean ± SD of the intraindividual differences between the test and the reference device was 0.70 ± 5.87 mmHg for SBP (pass criterion for the SD ≤6.90 mmHg) and -0.85 ± 4.19 mmHg for DBP (pass criterion for the SD ≤6.88 mmHg). The Microlife BP B3 AFIB/ERP No: BP3KT1-3 N has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 protocol and can be recommended for home BP measurements in adolescents and adults.

This study aims to evaluate the accuracy of the Omron HBP-1320 electronic blood pressure (BP) monitor for ambulatory BP measurement in both pediatric and adult populations according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) (ISO 81060-2:2018/Amd 1:2020) protocol. Subjects who met age, gender, BP, and cuff distribution criteria specified by the AAMI/ESH/ISO (ISO 81060-2:2018/Amd1:2020) protocol were recruited for this study. BP measurements were performed using the same-arm sequential measurement method. The test device was equipped with cuffs suitable for arm circumferences ranging from 12.0 to 42.0 cm. A total of 87 participants were initially recruited, with 85 (35 children and 50 adults) included in the final analysis after excluding two participants. The mean age of all participants was 38.1 ± 28.98 years, with children averaging 6.7 ± 2.23 years and adults 60.1 ± 15.39 years. For validation criterion 1, the mean ± SD of differences between the test device and reference BP measurements was 2.3 ± 5.47 mmHg for SBP and 1.3 ± 5.65 mmHg for DBP. Both mean differences were ≤5 mmHg, and SDs ≤ 8 mmHg, meeting the criterion. For validation criterion 2, the mean differences were 2.3 ± 3.93 mmHg for SBP and 1.3 ± 5.13 mmHg for DBP, satisfying the thresholds of ≤6.55 mmHg for SBP and ≤6.82 mmHg for DBP. The Omron HBP-1320 electronic BP monitor meets the requirements of the AAMI/ESH/ISO (ISO 81060-2:2018/Amd 1:2020) validation standard for adults and children.

To evaluate the accuracy of the InBody BP170 oscillometric upper-arm home 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 fulfill 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). One-hundred five 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 0.9 ± 6.9/0.5 ± 5.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.77/4.80 mmHg (systolic/diastolic). The InBody BP170 oscillometric home BP monitor 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 KANG KC-2850 ambulatory blood pressure monitor (ABPM) for clinical blood pressure (BP) measurement 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). BP was sequentially measured and compared with a standard mercury sphygmomanometer in 85 eligible participants. A standard adult cuff (22-3232 cm) was used for test device measurements. A total of 255 comparison pairs were obtained and analyzed according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO universal standard. The standard requirements were followed precisely. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -1.12 ± 5.01 and -0.33 ± 4.52 mmHg for SBP and DBP, respectively. For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 3.59 and 3.60 mmHg for SBP and DBP, respectively. The KANG KC-2850 ABPM met all the requirements for validation by the AAMI/ESH/ISO universal standard and can be recommended for clinical use in general population.

A noninvasive blood pressure monitor (model BP8800MS, Colin Medical Instruments Corp., San Antonio, TX) that uses the oscillometric principle was evaluated against the manual auscultatory method in 85 adults and 85 children following the requirements of the 1992 AAMI SP-10 standard. This was the first evaluation study of the electronic sphygmomanometers according to the new AAMI standards. In adult subjects, the mean difference and standard deviation of the differences between the oscillometric and auscultatory methods were 2.81 +/- 5.35 mm Hg (mean +/- SD) for systolic and 0.04 +/- 4.90 mm Hg for diastolic; in children, they were 3.18 +/- 5.96 mm Hg for systolic and -0.82 +/- 5.24 mm Hg for diastolic. Excellent correlation between the oscillometric and auscultatory methods, particularly the diastolic pressure, is due to usage of the Phase V Korotkoff's sounds for auscultatory detection of the diastolic pressure, increased accuracy of the two observers' measurements, and proper selection of cuff sizes depending on the mid-arm circumference. Five different-sized cuffs were used in this study. The cuff-width-to-midarm circumference ratio was adjusted to be 0.4 or larger to minimize the measurement error associated with mismatch of cuff-size/arm-size relationship. The distribution of errors associated with each cuff was nearly the same. The 1992 AAMI SP-10 standards offer a thorough evaluation of the oscillometric sphygmomanometer by enforcing more stringent criteria on (1) agreement between two observers, (2) wide spectrum of blood pressure from hypertensive (above 180 mm Hg) to hypotensive, and (3) data analysis. The oscillometric blood pressure monitor evaluated in this study meets the specifications of the new AAMI SP-10 standards and can offer an accurate, automatic, and noninvasive measure of both systolic and diastolic blood pressure in adults and children. It can safely replace the manual or automatic auscultatory system in various clinical settings.