Upper-arm Blood Pressure Monitor Research Articles

Validation of the Pangao PG-800B5 for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010.

This study aimed to validate the Pangao PG-800B5 upper arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. A total of 33 participants, 16 men and 17 women, were included in the device evaluation. The protocol requirements were followed precisely. The mean age of the participants was 56.4±21.0 years (range 22-84 years). The mean systolic blood pressure was 143.6±25.5 mmHg (range 98-188 mmHg), the mean diastolic blood pressure was 85.7±17.2 mmHg (range 49-125 mmHg), and the mean arm circumference was 26.1±2.2 cm (range 23-32 cm). On average, the device overestimated the systolic blood pressure by 0.9±4.2 mmHg and diastolic blood pressure by 0.7±4.5 mmHg. The device passed all requirements, fulfilling the standards of the protocol. Therefore, the Pangao PG-800B5 upper arm blood pressure monitor can be recommended for clinical use and self-measurement in an adult population.

Validation of the Andon KD-5917 automatic upper arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

To validate the Andon KD-5917 automatic upper arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Sequential same-left-arm measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were obtained in 33 participants using the mercury sphygmomanometer and the test device. According to the validation protocol, 99 pairs of test device and reference blood pressure measurements (three pairs for each of the 33 participants) were obtained in the study. The device produced 73, 98, and 99 measurements within 5, 10, and 15 mmHg for SBP and 86, 98, and 99 for DBP, respectively. The mean ± SD device-observer difference was 3.07 ± 3.68 mmHg for SBP and -0.89 ± 3.72 mmHg for DBP. The number of patients with two or three of the device-observer difference within 5 mmHg was 26 for SBP and 29 for DBP, and no patient had a device-observer difference within 5 mmHg. The Andon KD-5917 automatic upper arm blood pressure monitor can be recommended for clinical use and self-measurement in an adult population on the basis of the European Society of Hypertension International Protocol revision 2010.

Validation of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010

The present study aimed to evaluate the accuracy of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (14 women, mean age of 47 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM63S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the blood pressure requirements were fulfilled. The AVITA BPM63S device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 68/99, 89/99, and 96/99, respectively, for systolic blood pressure, and 75/99, 95/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-four and 25 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required ≥24). One and two participants for systolic and diastolic blood pressure, respectively, had all three device-observers differences greater than 5 mmHg. The AVITA BPM63S automated oscillometric upper arm blood pressure monitor has passed the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement at home in adults.

Validation of the iHealth BP5 wireless upper arm blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010

The aim of this study was to validate the iHealth BP5 wireless upper arm blood pressure (BP) monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for validation of BP measuring devices in adults was followed precisely. A total of 99 pairs of test device and reference BP measurements (three pairs for each of the 33 participants) were obtained in the study. The device produced 71, 89, and 97 measurements within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 73, 90, and 99 mmHg for diastolic blood pressure (DBP), respectively. The mean ± SD device-observer difference was -1.21 ± 5.87 mmHg for SBP and -1.04 ± 5.28 mmHg for DBP. The number of participants with two or three device-observer differences within 5 mmHg was 25 for SBP and 28 for DBP. In addition, three participants had no device-observer difference within 5 mmHg for SBP and none of the participants had the same for DBP. According to the validation results on the basis of the ESH-IP revision 2010, the iHealth BP5 wireless upper arm BP monitor can be recommended for self/home measurement in an adult population.

Validation of the A&D UA-1020 upper-arm blood pressure monitor with six different-shaped or different-sized cuffs according to the British Hypertension Society protocol

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure monitor A&D UA-1020 with six different-shaped or different-sized cuffs according to the British Hypertension Society protocol. We recruited 136 individuals for four D-ring cuffs (adult, large, small, and medium) and 114 individuals for two cylindrical cuffs (adult and medium). For each participant, we sequentially measured systolic and diastolic blood pressure using a mercury sphygmomanometer (two observers) and UA-1020 (one supervisor) to obtain three pairs of comparisons. For the four D-ring cuffs, the device achieved grade A. The percentage of blood pressure differences within 5, 10, and 15 mmHg was 64, 88, and 96%, respectively, for systolic blood pressure, and 69, 92, and 99%, respectively, for diastolic blood pressure. The average (± SD) of the device-observers differences was -1.2 ± 7.2 mmHg (P = 0.0006) and 1.0 ± 6.0 mmHg (P < 0.0001) for systolic and diastolic blood pressure, respectively. For the two cylindrical cuffs, the device also achieved grade A. The percentage of blood pressure differences within 5, 10, and 15 mmHg was 65, 87, and 96%, respectively, for systolic blood pressure, and 64, 91, and 98%, respectively, for diastolic blood pressure. The average of the device-observers differences was -0.4 ± 7.3 mmHg (P = 0.29) and 2.0 ± 6.1 mmHg (P < 0.0001) for systolic and diastolic blood pressure, respectively. The UA-1020 device has passed the requirements of the British Hypertension Society protocol with various sizes of D-ring and cylindrical cuffs, and can be recommended in adults.

Lack of validation of the Dixtal (DX 2020) upper arm blood pressure monitor, in oscillometric mode, for clinical use in an intensive care unit, according to the European Society of Hypertension-International Protocol revision 2010

The aim of the study was to evaluate the accuracy of the oscillometric blood pressure section in the DX 2020 Dixtal multiparametric monitor in adults according to the European Society of Hypertension-International Protocol as revised in 2010 (ESH-IP 2010). The blood pressure was sequentially verified in 33 individuals admitted to an adult ICU (18 men, mean age 44 years) with a mercury column sphygmomanometer (two observers) and the DX 2020 test device (one supervisor). Ninety-nine pairs of differences were obtained. Data analysis followed the ESH-IP 2010 requirements. In the first requirement, the DX 2020 device failed in the validation study in the 5, 10, and 15 mmHg ranges. From the 99 pairs of differences, only 43/73, 69/87, and 81/96 were obtained for systolic blood pressure and 29/65, 56/81, and 71/93 were obtained for diastolic blood pressure. In the second requirement, at least 24 individuals should have, from their comparisons, two under 0-5 mmHg ranges, which was observed only with 16 individuals in the systolic and nine in the diastolic range. Moreover, at maximum, only three readings could have differences of more than 5 mmHg, and this was observed in 10 individuals in the systolic range and 17 individuals in the diastolic range. The DX 2020 automatic multiparametric monitor for blood pressure measurement has not been recommended for clinical use according to the ESH-IP 2010. It is important to highlight that this work refers only to a blood pressure measurement module and that the same conclusion cannot be drawn for its other functions.

Validation of the fully automated A&amp;D TM-2656 blood pressure monitor according to the British Hypertension Society Protocol

The present study aimed to evaluate the accuracy of the fully automated oscillometric upper-arm blood pressure monitor TM-2656 according to the British Hypertension Society (BHS) Protocol 1993. We recruited individuals until there were 85 eligible participants and their blood pressure could meet the blood pressure distribution requirements specified by the BHS Protocol. For each individual, we sequentially measured the systolic and diastolic blood pressures using a mercury sphygmomanometer (two observers) and the TM-2656 device (one supervisor). Data analysis was carried out according to the BHS Protocol. The device achieved grade A. The percentage of blood pressure differences within 5, 10, and 15 mmHg was 62, 85, and 96%, respectively, for systolic blood pressure, and 71, 93, and 99%, respectively, for diastolic blood pressure. The average (±SD) of the device-observer differences was -2.1±7.8 mmHg (P<0.0001) and -1.1±5.8 mmHg (P<0.0001) for systolic and diastolic blood pressures, respectively. The A&D upper-arm blood pressure monitor TM-2656 has passed the requirements of the BHS Protocol, and can thus be recommended for blood pressure measurement.

Validation of the A&amp;D UA-1020 upper-arm blood pressure monitor for home blood pressure monitoring according to the British Hypertension Society Protocol

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure (BP) monitor A&D UA-1020 with two different-shaped cuffs for home BP monitoring according to the British Hypertension Society (BHS) Protocol. We recruited individuals for each of the two cuffs (D-ring and cylindrical) until there were 85 eligible participants (255 pairs of comparisons) and their BP could meet the BP distribution requirements specified by the BHS Protocol. For each participant, we sequentially measured the systolic and diastolic BP using a mercury sphygmomanometer (two observers) and the UA-1020 device (one supervisor). For the D-ring cuff, the device achieved grade A. The percentage of BP differences within 5, 10, and 15 mmHg was 67, 87, and 96%, respectively, for systolic BP, and 70, 90, and 99%, respectively, for diastolic BP. The average (±SD) of the device-observer differences was -0.2±7.3 mmHg (P=0.64) and 1.7±5.8 mmHg (P<0.0001) for systolic and diastolic BP, respectively. For the cylindrical cuff, the device also achieved grade A. The percentage of BP differences within 5, 10, and 15 mmHg was 67, 88, and 97%, respectively, for systolic BP and 64, 89, and 98%, respectively, for diastolic BP. The average of the device-observer differences was -0.1±7.0 mmHg (P=0.89) and 2.0±6.3 mmHg (P<0.0001) for systolic and diastolic BP, respectively. The UA-1020 device has passed the requirements of the BHS Protocol with both the D-ring and the cylindrical cuffs, and hence can be recommended for home use in adults.

Validation of the Omron HEM-7201 upper arm blood pressure monitor, for self-measurement in a high-altitude environment, according to the European Society of Hypertension International Protocol revision 2010.

Few studies have been conducted on blood pressure monitors and their use at high altitude. This study is the first to evaluate an automated blood pressure device at high altitude following a standard validation protocol. The Omron HEM-7201 upper arm automatic blood pressure monitor was tested for accuracy in Lhasa, Tibet, China (3650 m above sea level) according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2). Thirty-three participants received 9–10 sequential blood pressure measurements alternating from a mercury sphygmomanometer and the device. The mean device-observer measurement difference was 1.0 ± 5.9 mmHg for systolic blood pressure (SBP) and −3.1 ± 4.6 mmHg for diastolic blood pressure (DBP). Of the 99 measurement pairs analyzed, 72, 90, and 97 device readings were within 5, 10, and 15 mmHg, respectively, of the observer measurements for SBP, and 68, 92, and 99 readings for DBP. The number of participants with at least two out of three measurements within 5mmHg was 27 for SBP and 25 for DBP. Three participants had no measurements within 5 mmHg for SBP or DBP. The Omron HEM-7201 passes the ESH-IP2 validation criteria and can therefore be recommended for use in adults in this setting.

Validation of the Beurer BM 44 upper arm blood pressure monitor for home measurement, according to the European Society of Hypertension International Protocol 2002

The present study aimed to validate the automated upper arm blood pressure (BP) measuring device BM 44 for home BP monitoring according to the 2002 Protocol of the European Society of Hypertension. The most important new feature of the new device was an integrated 'WHO indicator', which categorizes the patient's individual result within the WHO recommendations for target BP by a coloured scale. Systolic and diastolic BPs were measured sequentially in 35 adult participants (16 men, 19 women) using a standard mercury y-tubed reference sphygmomanometer (two observers) and the BM 44 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. The BM 44 device passed phase 1 of the validation study successfully with a number of absolute differences between device and observers of 5, 10 and 15 mmHg for at least 28 out of 25, 35 out of 35 and 40 out of 40 measurements, respectively. The device also achieved the targets for phases 2.1 and 2.2, with 23 and 26 participants having had at least two of three device-observers differences within 5 mmHg for systolic and diastolic BP, respectively. The Beurer BM 44 upper arm BP monitor has passed the International Protocol requirements, and hence can be recommended for home use in adults.

Validation of the iHealth BP3 upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010

This study aimed to evaluate the performance of the iHealth BP3 upper-arm blood pressure monitor, which is designed for clinic use and self-measurement of blood pressure using Apple touch devices as an interface. The European Society of Hypertension International Protocol (ESH-IP) revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. Ninty-nine couples of test device and reference blood pressure measurements were obtained during the study (three pairs for each of the 33 participants). The 33 participants, age 47.1±12.3 years (age range 27-69 years) and arm circumference 30.0±4.4 cm, had a mean systolic blood pressure (SBP) of 143.9±27.4 mmHg and a mean diastolic blood pressure (DBP) of 90.1±18.3 mmHg. The device passed all of the requirements fulfilling the standards of the protocol, and the mean±SD device-observer difference was 2.8±4.2 mmHg for SBP and -0.4±3.5 mmHg for DBP. According to the results of the validation study on the basis of the ESH-IP revision 2010, the iHealth BP3 can be recommended for clinic use and self-measurement in an adult population.

Validation of A&amp;D TM-2430 upper-arm blood pressure monitor for ambulatory blood pressure monitoring in children and adolescents, according to the British Hypertension Society protocol

The A&D TM-2430 ambulatory blood pressure (BP) monitor has been validated in adults but not in a young population. We sought to validate the device monitoring in children and adolescents, according to the British Hypertension Society (BHS) protocol. The A&D TM-2430 is an automated oscillometric upper-arm device for ambulatory BP monitoring. Nine consecutive measurements were taken in 61 children (mean age, 9.8 years; range, 5-15 years) according to the BHS criteria. Overseen by an independent supervisor, measurements were recorded by two observers blinded from each other's readings and from the device readings. The mean difference ± SD between the observers and device measurements was 0.73 ± 1.64 mmHg for systolic blood pressure (SBP) and -1.23 ± 1.65 mmHg for diastolic blood pressure (DBP), respectively, with an interobserver difference of 4 mmHg. The cumulative percentages of differences within 5, 10, and 15 mmHg were 89, 95, and 98% for SBP and 67, 88, and 98% for DBP. The device achieved a grade A rating for SBP and a B grade for DBP. The A&D TM-2430 upper-arm BP monitor has fulfilled the required BHS standards and can be recommended for measuring ambulatory BP in children and adolescent populations.

Validation of the Kingyield BP210 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension-International Protocol

The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor BP210 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese participants (21 women, 51 years of mean age) using a mercury sphygmomanometer (two observers) and the BP210 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. Data analysis was conducted using the ESHIP analyzer. The BP210 device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 33/45, 44/45, and 44/45 measurements, respectively. The device also achieved the targets for phase 2.1, with 77/99, 95/99, and 97/99 differences within 5, 10, and 15 mmHg, respectively for systolic blood pressure, and with 78/99, 97/99, and 99/99 within 5, 10, and 15 mmHg, respectively for diastolic blood pressure. In phase 2.2, 29 and 25 participants had at least two of the three device-observers differences within 5 mmHg (required≥22) for systolic blood pressure and diastolic blood pressure, respectively. The Kingyield wrist blood pressure monitor BP210 has passed the International Protocol requirements, and hence can be recommended for home use in adults.

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

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. 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. 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. 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 Omron M3 Intellisense (HEM-7051-E) Upper Arm Blood Pressure Monitor, for Self-Measurement, according to the European Society of Hypertension International Protocol Revision 2010 in a Stage 3–5 Chronic Kidney Disease Population

Background: Encouragement of home blood pressure (BP) monitoring has a great potential to improve hypertension control rates. The purpose of this study was to test validation of the Omron M3 Intellisense (HEM-7051-E) upper arm BP measuring monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in stage 3–5 chronic kidney disease (CKD) patients. Methods: 66 patients having CKD stage 3–5 were included in the study. Nine consecutive measurements were made according to the ESH-IP2 protocol. Results: The Omron M3 Intellisense device fulfills the validation criteria of the ESH-IP2 for stage 3–5 CKD patients. Conclusion: Although arterial stiffness can affect accurate BP measurement, there are limited data regarding the use of automated oscillometric devices in CKD. To our knowledge, this is the first study investigating validation of an oscillometric device in stage 3–5 predialysis CKD patients. This study validates the Omron M3 Intellisense upper arm device for stage 3–5 CKD patients. New validation studies investigating other oscillometric sphygmomanometers for CKD patients and involvement of nephrologists in these studies have great potential to increase patient care in CKD.

Validation of the Medipro MediCare 100f upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010

The validation of sphygmomanometer is important in accurate blood pressure measurement. This study presents the validation results by the Medipro MediCare 100f upper arm blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. A total of 99 couples of test device and reference blood pressure measurements were obtained during the study (three pairs for each of the 33 participants). The device produced 73, 93, and 98 measurements within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 79, 93, and 96 for diastolic blood pressure (DBP), respectively. The mean standard deviation device-observer difference was 1.4 ± 5.2 mmHg for SBP and 0.02±5.8 mmHg for DBP. The number of participants with two or three of the device-observer differences within 5 mmHg was 24 for SBP and 30 for DBP, whereas there was no participant with none of the device-observer differences within 5 mmHg. According to the results of the validation study based on the ESH-IP revision 2010, the Medipro MediCare 100f can be recommended for self-measurement in an adult population.

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

To validate the UEBE Visomat Double Comfort, an upper arm blood pressure monitor, in a general population according to the European Society of Hypertension International Protocol revision 2010. The Visomat Double Comfort is a device designed for self-measurement of blood pressure and for clinical use. The monitor is provided with two operational modalities, a microphonic mode and an oscillometric mode. In this study, the auscultatory modality was tested. Device evaluation was performed in 33 participants with a mean±standard deviation age of 55±20 years (age range 25–88 years). Their systolic blood pressure was 140±28 mmHg, diastolic blood pressure was 87±17 mmHg, and arm circumference was 29±4 cm. 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 −1.1±4.0 mmHg for systolic blood pressure and −0.4±4.1 mmHg for diastolic blood pressure. As the Visomat Double Comfort has achieved the required standards, it is recommended for clinical use in an adult population.

Validation of the Medisana MTP Plus upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010

Standard validation protocols are objective guides for healthcare providers, physicians, and patients. The purpose of this study was to test validation of the Medisana MTP Plus upper arm blood pressure (BP) measuring monitor for self-measurement according to the European Society of Hypertension International Protocol (ESH-IP2) in adults. The Medisana MTP Plus monitor is an automated and oscillometric upper arm device for home BP monitoring. Nine consecutive measurements were made according to the ESH-IP2. Overseen by an independent supervisor, measurements were recorded by two observers blinded from both each other's readings and from the device readings. The Medisana MTP Plus device fulfills the validation criteria of the ESH-IP2 for the general population. The mean (standard deviation) of the difference between the observers and the device measurements was 0.6 mmHg (5.1 mmHg) for systolic and 2.7 mmHg (3.4 mmHg) for diastolic pressures, respectively. As the Medisana MTP Plus device has achieved the required standards, it is recommended for home BP monitoring in an adult population.

Validation study of the Dinamap ProCare 200 upper arm blood pressure monitor in children and adolescents

PurposeTo validate the Dinamap ProCare 200 blood pressure (BP) monitor against a mercury sphygmomanometer in children 7 to 18 years old in accordance with the 2010 International Protocol of European Society of Hypertension (ESH-IP2) and the British Hypertension Society (BHS) protocol.MethodsForty-five children were recruited for the study. A validation procedure was performed following the protocol based on the ESH-IP2 and BHS protocols for children and adolescents. Each subject underwent 7 sequential BP measurements alternatively with a mercury sphygmomanometer and the test device by trained nurses. The results were analyzed according to the validation criteria of ESH-IP2.ResultsThe mean (±SD) difference in the absolute BP values between test device and mercury sphygmomanometer readings was 1.85±1.65 mmHg for systolic BP (SBP) and 4.41±3.53 mmHg for diastolic BP (DBP). These results fulfilled the Association for the Advancement of Medical Instrumentation criterion of a mean±SD below 5±8 mmHg for both SBP and DBP. The percentages of test device-observer mercury sphygmomanometer BP differences within 5, 10, and 15 mmHg were 96%, 100%, and 100% for SBP, and 69%, 92%, and 100% for DBP, respectively, in the part 1 analysis; both SBP and DBP passed the part 1 criteria. In the part 2 analysis, SBP passed the criteria but DBP failed.ConclusionAlthough the Dinamap ProCare 200 BP monitor failed an adapted ESH-IP2, SBP passed. When comparing BP readings measured by oscillometers and mercury sphygmomanometers, one has to consider the differences between them, particularly in DBP, because DBP can be underestimated.

Validation of the Kingyield BP101H blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor BP101H (Kingyield Technology, Shenzhen, China) for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese participants (13 women, 52.6 years of mean age) using a mercury sphygmomanometer (two observers) and the BP101H device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and further 18 participants in phase 2 of the validation study. Data analysis was done using the ESHIP Analyzer. The BP101H device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 34/45, 42/45, and 43/45 measurements, respectively. The device also achieved the targets for phase 2.1, with 79/99, 94/99, and 96/99 differences within 5, 10, and 15 mmHg, respectively, for systolic blood pressure, and with 81/99, 94/99, and 98/99 within 5, 10, and 15 mmHg, respectively, for diastolic blood pressure. In phase 2.2, 27 and 28 participants had at least two of the three device-observers differences within 5 mmHg (required ≥22) for systolic blood pressure and diastolic blood pressure, respectively. The Kingyield upper arm blood pressure monitor BP101H has passed the International Protocol requirements, and hence can be recommended for home use in adults.