Upper-arm Blood Pressure Monitor Research Articles

Clinical Accuracy of the G.LAB MD41A0 Upper Arm Blood Pressure Monitor in Pregnancy and Pre-Eclampsia Using the AAMI/ESH/ISO as Reference Standard.

Validation of blood pressure (BP) monitors in pregnant women are needed to ensure the accurate measurement of BP in pregnancy. Therefore the study aimed to evaluate the measurement accuracy of the G.LAB MD41A0 oscillometric automatic upper-arm blood pressure monitor in pregnancy and pre-eclampsia women according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018). A total of 45 pregnant women were included in the cross-sectional validation study. The same left-arm sequential method was used for blood pressure measurement, and the blood pressure differences between the test device and the mercury standard reference were assessed according to the AAMI/ESH/ISO Universal Standard. The participants included 15 normotensives, 15 gestational hypertension and 15 pre-eclampsia. The average (mean ± SD) differences between the device and mercury standard was -0.84±3.88mmHg and -0.58±3.35mmHg for systolic and diastolic blood pressure, respectively, for the validation Criterion 1. The SD of the averaged differences between the device and reference readings per participant was 2.92mmHg and 2.28mmHg for systolic and diastolic blood pressure, respectively, for the Criterion 2 of the universal standard. The G.LAB MD41A0 automatic upper-arm blood pressure monitor fulfills the criteria of the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement in pregnancy and pre-eclampsia.

Determinants of adherence among patients with hypertension

Abstract Background Poor adherence to pharmacological treatment among patients with hypertension (HTN) is common. Approximately half of HTN patients do not use their medications as prescribed. Multiple barriers can influence adherence to antihypertensive medications. HTN patients may be characterized by the presence of frailty syndrome (FS) and cognitive impairment (CI). FS and CI may adversely affect the course of the disease and adherence to therapeutic recommendations. Purpose To assess the adherence and its determinants among patients with hypertension. Methods The study included 129 patients diagnosed with hypertension (81 men, 48 women; mean age M±SD=69.98±11.67) hospitalized in the Department of Occupational Diseases and Hypertension. Medical record analysis, the author's sociodemographic questionnaire, the Tilburg Frailty Idicator (TFI) to determine the presence of frailty syndrome, the Montreal Cognitive Assesment (MoCa) questionnaire to assess cognitive function, and the Adherence to Medication Scale (ARMS) to assess adherence were used. Results The majority of respondents were male (62.79%), living in large cities (31.78%), in a relationship (61.24%), with a high school education (68.22%), and retired (67.44%). Analysis of medical records among comorbidities showed diabetes (59.69%) and other cardiovascular diseases (58.91%) to be the most common. Hospitalizations due to hypertension within the past year in the range of 1-2 were reported in 72.09% of the subjects, 3-5 hospitalizations in 17.05%, and more than 5 hospitalizations in 10.85% subjects. The surveyed patients mostly kept self-monitoring diaries (61.24%), measured their blood pressure values 2-3 times a day (58.15%) with an upper arm blood pressure monitor (64.34%). In terms of self-care behaviors, respondents most often indicated following a diet with a restriction of unhealthy fats (52.71%), following a low-sodium diet (44.19%) and being physically active (33.33%). The mean blood pressure values in the study group were M±SD=139.73±16.73 mmHg for SBP and M±SD=81.48±13.25 mmHg for DBP, respectively. On the basis of the TFI, 99.22% of patients showed the presence of FS (M±SD =10.66±2.82), the MoCa questionnaire indicated abnormal values in cognitive function in 79.07% (M±SD =18.16±8.3). The average adherence ARMS score was M±SD 17,6±6,72 pcts. (higher the ARMS score the worse adherence). Univariate analysis as determinants of adherence showed unemployment (b=9.391;p=0.001), smoking (b=6.701;p=0.001), duration of illness (b=-0.153;p=0.003), 3-5 hospitalizations in the past year (b=3.891;p=0.014). Multivariate analysis among determinants of adherence showed unemployment (b=7.556;p=0.022), duration of illness (b=-0.167;p=0.002) and 3-5 hospitalizations (b=5.011;p=0.001). Conclusion Hypertensive patients are characterized by optimal adherence. Despite expectations, cognitive impairment and frailty syndrome did not determine adherence to medications.

Validation of the AViTA upper-arm blood pressure monitor BP636 with multiple cuff sizes in the general population according to the ANSI/AAMI/ISO 81060-2:2018/Amd1:2020.

To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020). The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15-22 cm, normal: 22-33 cm, large: 33-42 cm, and extra large: 42-52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method. For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was -0.35 mmHg with a SD of 3.50 mmHg, wh{ich was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg). AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm.

Validation of the JAMR upper-arm pressure monitor B23 according to the AAMI/ESH/ISO Universal Standard (ISO 81060- 2:2018/AMD 1:2020).

The aim of this study was to evaluate the accuracy of the JAMR upper-arm blood pressure monitor B23 in the general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). The study recruited participants who met the criteria of the AAMI/ESH/ISO Universal Standard in terms of their number, sex, age, limb size, and blood pressure (BP) distribution. The study involved measuring BP, including both SBP and DBP, using both the test device and a standard mercury sphygmomanometer in sequential measurements. Of 90 participants, 85 qualified participants were analyzed. A total of 255 sets of comparison data (three sets for each subject) were obtained and analyzed. For the validation criterion 1, the mean ± SD of the differences between the JAMR B23 and mercury sphygmomanometer BP readings was -0.24 ± 6.52/-2.67 ± 5.6 mmHg (SBP/DBP). For criterion 2, the SD of the averaged BP (SBP/DBP) differences between the JAMR B23 and reference BP (SBP/DBP) per participant was 5.61/5.13 mmHg (the requirement was ≤6.95/6.43 mmHg by calculation). The JAMR B23 passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020) and can be recommended for clinical and self/home use in the general population.

IMPACT OF OCCUPATIONAL NOISE ON THE CIRCULATORY SYSTEM OF WORKERS IN A TYPICAL FLOATING PRODUCTION VESSEL

This study investigates the possible impacts of occupational noise exposure on the circulatory system of workers in a typical floating, production, storage and offloading (FPSO) unit in the Niger Delta Offshore work environment in Nigeria. The VLIKE iiVL6708 digital sound level meter was used to measure noise levels at 2-hour interval overianii8-houriiworkday. OMRON-10iiSeries iiBP7450 Upper Arm Blood Pressure monitor was used to measure arterial blood pressure i(systolic and diastolic) and pulse rate of work before and after exposure for 8-hour workday.

Validation of the ANDON KD-595 automated upper-arm blood pressure monitor according to the universal standard.

To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard. For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ± 5.35 and 0.82 ± 5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively. The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.

Validation of the iHealth Track upper-arm blood pressure monitor KN-550BT in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).

To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020). Participants were recruited and the same left-arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results. A total of 89 qualified participants were included in the final analysis. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference readings was -1.22 ± 5.76 mmHg and -0.08 ± 4.40 mmHg for systolic and diastolic blood pressure, respectively. For Criterion 2, the mean ± SD of the differences between the test device and reference readings per participant was -1.22 ± 5.06 mmHg and -0.08 ± 3.84 mmHg for systolic and diastolic blood pressure, respectively. The iHealth Track KN-550BT upper-arm blood pressure monitor passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020) and can be recommended for clinical use and self-measurement in general population.

Validation of the JOYTECH DBP-6279B blood pressure monitor in adults and adolescents according to the AAMI/ESH/ISO universal standard(ISO 81060-2:2018 + Amd.1:2020).

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.

Validation of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) and the International Organization for Standardization Amendment 1. 2020.

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.

Validation of the AViTA BPM636 upper arm blood pressure monitor in adults and pregnant women according to the ANSI/AAMI/ISO 81060-2:2013.

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.

Effect of the inferior alveolar nerve block injection versus maxillary infiltration with two local anesthetic agents on cardiovascular parameters: A randomized comparative double-blind clinical trial

Abstract This study aimed to assess the effect of inferior alveolar nerve (IAN) block of the mandible and infiltration anesthesia of the maxilla using lidocaine plus epinephrine or prilocaine with felypressin anesthetic agents on systolic and diastolic blood pressures, heart rate (HR) and peripheral oxygen saturation rate of patients. This randomized double-blind clinical trial evaluated 112 patients in four groups (n=28) based on the jaw (maxilla or mandible) and type of anesthetic agent (lidocaine with epinephrine or prilocaine with felypressin). Groups 1 and 2 received IAN block of the mandible or infiltration anesthesia of the maxilla, respectively, with 2% lidocaine plus 1:80.000 epinephrine. Groups 3 and 4 received IAN block of the mandible or infiltration anesthesia of the maxilla, respectively, using prilocaine with felypressin. Systolic and diastolic blood pressures and HR were measured by an automatic upper arm blood pressure monitor and the percentage of peripheral oxygen saturation rate was measured by a finger pulse oximeter 10 minutes before the injection, immediately after injection, 10 minutes after injection and 20 minutes after injection. The mean diastolic blood pressure showed a greater reduction following the administration of lidocaine with epinephrine, as compared with prilocaine with felypressin (p<0.001). The mean HR showed a significantly greater increase following the administration of lidocaine with epinephrine, as compared with prilocaine with felypressin (p<0.001). The effect of type of anesthetic agent on diastolic blood pressure depended on the type of injection (p=0.033). Administration of 2% lidocaine with 1:80.000 epinephrine, in comparison to prilocaine with felypressin, can cause changes in cardiovascular parameters such as heart rate and diastolic blood pressure in patients undergoing restoration of a maxillary or mandibular molar tooth. Type of injection has no significant effect on cardiovascular parameters.

Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials.

Controlled clinical intervention studies have demonstrated that cocoa flavanols (CF) can decrease blood pressure and arterial stiffness in healthy humans, although a large variability in the effect size across trials has been reported. In this study, we evaluated the intra- and inter-individual variability of responses to CF in everyday life using a series of n-of-1 trials in healthy free-living individuals with normal blood pressure carrying personal devices. In total, eleven healthy young humans participated in a repeated crossover randomized controlled double-blind n-of-1 trial. On 8 consecutive days, each volunteer consumed on alternating days 6 CF capsules (862 mg CF) on 4 days and 6 matched placebo capsules (P, 0 mg CF/day) on another 4 days in one of the two randomized sequences (CF-P-CF-P-CF-P-CF-P or P-CF-P-CF-P-CF-P-CF). On each day, the capsules were taken at the same time in the morning with breakfast after baseline measurements. Each subject was provided with an upper arm blood pressure monitor and a finger clip that measures pulse wave velocity (PWV). Measurements of blood pressure, heart rate, and PWV were taken at least hourly over 12 h during the day by the participants. On the first 2 days, measurements were performed under supervision to provide training. The overall mixed model analysis showed that CF significantly decreased 12-h systolic blood pressure and PWV by −1.4 ± 0.3 mmHg and −0.11 ± 0.03 m/s, respectively. Peak effects were observed within the first 3 h (1.5 h SBP: −4.9 ± 2.2 mmHg, PWV: −0.32 ± 0.17 m/s) and again after 8 h post-ingestion. Large inter-individual variation in responses was found [intra-cluster correlation coefficients (ICC): 0.41, 0.41]. When analyzing single individuals’ datasets, there was also considerable between-day variation in individual responses that varied greatly between subjects (ICC: 0–0.30, 0–0.22, 0–0.45). Effect sizes inversely correlated with baseline blood pressure values both between- and within-subjects. The data confirm that cocoa can decrease blood pressure and arterial stiffness in everyday life when elevated within the normal range. The large inter- and intra-individual variation in responses calls for more personalized nutritional intervention strategies.

Validation of the G.LAB MD41A0 upper arm blood pressure monitor in patients with diabetes mellitus according to the AAMI/ESH/ISO 81060-2:2018 Universal Standard.

The objective of this study is to determine the accuracy of the G.LAB MD41A0 upper-arm oscillometric blood pressure (BP) monitor for self/home BP measurement in patients with diabetes 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). Patients with diabetes were recruited according to AAMI/ESH/ISO Universal Standard using the same arm sequential BP measurement method. The standard cuff of the test device was used for arm circumference 22-44 cm. A total of 92 patients with diabetes were recruited and 85 were analyzed with an average age of 55.1 ± 17.7 years, 48 men, and arm circumference of 32.0 ± 6.0 cm. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.89 ± 6.04/-0.84 ± 5.11 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 4.23/4.19 mmHg (systolic/diastolic). The G.LAB MD41A0 upper arm BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in patients with diabetes and can be recommended for self/home use.

Prevalence and control of hypertension among people living with HIV receiving care at a Nigerian hospital

Introductionwith the introduction of newer and safer antiretroviral drugs, HIV positive persons are now living longer. Consequently, cardiovascular diseases associated with ageing and chronic low grade inflammation due to the presence of the virus are increasingly found in this population. This study aimed to assess the prevalence and control of hypertension among people living with HIV (PLHIV) receiving care at a Nigerian hospital.Methodsthis cross-sectional study was conducted as part of the Patient´s HIV Knowledge Questionnaire (PHKQ) validation study among HIV positive outpatients at the University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria. Hypertension was self-reported and confirmed by a documented physician diagnosis in the patient´s case notes and/or self-reported use of antihypertensive medication. For each participant, the average of two close blood pressure (BP) measurements obtained using an automatic upper arm BP monitor was taken as the BP. Hypertension control was defined as SBP <140 mmHg and DBP <90 mmHg. Data were analysed using the Statistical Product and Service Solutions (SPSS) v.21.0. Results were considered significant at p < 0.05.Resultsprevalence of hypertension among PLHIV was 24.9%. Age (OR = 1.112, CI = 1.074 – 1.151, p < 0.001), body mass index (OR = 1.087, CI = 1.024 – 1.154, p = 0.004) and duration on antiretroviral therapy (OR = 1.169, CI = 1.090 – 1.254, p < 0.001) significantly predicted hypertension. Only 19 (24.4%) participants had controlled hypertension.Conclusionhypertension is common among PLHIV seeking care at a Nigerian hospital. However, its control remains suboptimal. Regular screening for hypertension, its appropriate treatment and optimal control are essential in PLHIV.

Validation of the Microlife BP B3 AFIB upper arm blood pressure monitor in adults and adolescents according to the ANSI/AAMI/ISO 81060-2:2019 protocol.

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.

Validation of the PHILIPS DL8760 upper arm blood pressure monitor, in oscillometry mode, for self-measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010.

The aim of this study was to determine the accuracy of the PHILIPS DL8760, an oscillometric blood pressure (BP) measuring device designed for self-measurement in the general population according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The PHILIPS DL8760 measures BP at the brachial level. The validation was performed in 33 subjects. The mean age of the participants was 55.8 ± 14 years. SBP 146.1 ± 26 mmHg (range: 103-193), DBP was 86.8 ± 17.0 mmHg (range: 47-123), and arm circumference was 28.3 ± 4.0 cm (range: 22-39). The PHILIPS DL8760 fulfilled the criteria of the ESH-IP by passing phases one and two for both SBP measurements and DBP measurements. The device overestimated SBP by 1.5 ± 5.0 mmHg and underestimated DBP by 0.7 ± 3.9 mmHg. The PHILIPS DL8760 BP device, with its specially designed cuff covering a broad range of arm circumferences, fulfilled the requirements of the International Protocol Revision 2010.

Validation of Omron HEM-7600T, a wearable device for monitoring blood pressure, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol in the general population without arrhythmias.

The present study aimed to evaluate the accuracy of the Omron HEM-7600T automated oscillometric upper-arm blood pressure (BP) monitor according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 protocol. We recruited individuals until we obtained 86 eligible participants whose BP levels and ranges of arm circumference met the BP distribution requirements specified by the ANSI/AAMI/ISO. In each individual, we sequentially measured systolic and diastolic blood pressures (DBPs) using a mercury sphygmomanometer (two observers) and the HEM-7600T device (one supervisor) in the left upper arm. Data analysis was performed according to the ANSI/AAMI/ISO guidelines. A total of 101 individuals were recruited, and 86 were finally included in the analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP was -0.6 ± 6.6/1.0 ± 6.5 mmHg (systolic/diastolic). The data were in accordance with criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤ 5 ± ≤ 8 mmHg). In addition, the mean device-observer difference in the 86 participants was -0.6 ± 5.65 mmHg for systolic blood pressure and 1.0 ± 5.96 mmHg for DBP, fulfilling criterion 2 with an SD of ≤6.91 mmHg for systolic blood pressure and ≤6.87 mmHg for DBP. The Omron HEM-7600T BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation protocol in adults and can be recommended for home BP measurements.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010: Erratum.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010: Erratum.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the British Hypertension Society Protocol: Erratum

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the British Hypertension Society Protocol: Erratum

Validation of the Globalcare GCE603 automated blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

To evaluate the accuracy of the automated oscillometric upper-arm blood pressure (BP) monitor Globalcare GCE603 for home BP monitoring according to the International Protocol of the European Society of Hypertension (ESH) revision 2010. BP was sequentially measured in 33 adult participants and compared with a standard mercury sphygmomanometer. A total of 99 comparison pairs were obtained and analyzed according to the ESH international protocol. For the 33 eligible participants, the device achieved 80/99, 98/99 and 99/99 measurements of absolute differences between device and observers within 5, 10 and 15 mmHg for systolic BP (SBP) and 87/99, 98/99 and 99/99 for diastolic BP (DBP), respectively. The average device-observer difference was 1.01 ± 4.11 mmHg for SBP and -0.69 ± 3.56 mmHg for DBP, respectively. The number of participants with two or three of the device-observer difference within 5 mmHg was 28 for SBP and 30 for DBP, and there was no subject with none of the device-observer difference within 5 mmHg. According to the validation results on the basis of the ESH international protocol revision 2010, the Globalcare GCE603 automated upper-arm BP monitor can be recommended for home measurement in general population.