Validation of a novel professional automated auscultatory upper-arm cuff blood pressure monitor in a general population according to the AAMI/ESH/ISO Universal Standard: KOROT V2 Doctor (InBody BPBIO280KV).

OBJECTIVE: A novel automated auscultatory upper arm cuff blood pressure (BP) monitor KOROT V2 Doctor (InBody BPBIO280KV) was developed for professional use. An electronic stethoscope embedded in the device cuff records the Korotkoff sounds, which are graphically displayed during deflation allowing visual evaluation by the healthcare professional. The device provides automated measurements of BP and this study evaluated its accuracy. METHODS: The requirements of 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 1.2020-01 were applied. Participants were recruited to fulfill the age, sex, BP, arm circumference, and cuff distribution criteria of the Universal Standard and its Amendment in a general population using the same arm sequential measurement method. Three cuffs of the test device were tested for arm circumference 23-28, 28-35, and 33-42 cm. RESULTS: Data from 85 individuals were analyzed [mean age: 56.4 ±â€…16.0 (SD) years, 50 men, arm circumference 23-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was -1.3 ± 6.0/1.5 ± 5.0 mmHg (systolic/diastolic; threshold ≤5 ±â€…8 mmHg). For Criterion 2, the SD of the averaged BP differences per individual (N = 85) was 4.61/3.48 mmHg (systolic/diastolic; threshold ≤6.82/6.78 mmHg). CONCLUSION: The KOROT V2 Doctor (InBody BPBIO280KV) device for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably fulfills 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.

Validation of the RBP-9801 oscillometric blood pressure monitor in the general population according to the association for the Advancement of Medical Instrumentation/European Society of Hypertension/ International Organization for Standardization Universal Standard.

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.

Validation of the Mindray VS9 Vital Signs Monitor in a combined adult and pediatric population according to ISO Standard 81060-2:2018.

We aimed to validate the accuracy of the Mindray VS9 Vital Signs Monitor, which features the Mindray TrueBP inflation algorithm for oscillometric blood pressure (BP) measurement, to check if it complies with the International Organization for Standardization Standard (ISO 81060-2:2018) in a combined adult and pediatric population. A total of 86 participants, including both adult and pediatric subjects, were recruited. The distribution of their ages, gender, BPs and limb sizes all complied with the requirement of the ISO standard. The inflation and deflation algorithms were validated independently using the same-arm sequential BP measurement method. For each subject, the BP was first determined by two independent observers using a mercury sphygmomanometer (R1). The BP of the subject was then determined by the third observer using the test equipment (T1). Then, using a mercury sphygmomanometer, two independent observers were asked to determine the subject's BP (R2) again. R1-T1-R2 were considered a valid pair of data. This cycle continued until 3 pairs of valid data were achieved. We collected 258 pairs of valid BP data for the validation of the inflation and deflation algorithms respectively. For validation Criterion 1, the mean ± SD of the differences between the readings obtained from the test device and reference BP was 0.0 ±â€…6.6/-1.8 ±â€…7.1 mmHg (systolic/diastolic) when the deflation algorithm was used, and 2.4 ±â€…6.3/ 0.3 ±â€…6.9 mmHg (systolic/diastolic) when the inflation algorithm was used. For validation Criterion 2, the SD of the averaged BP differences between the test device and the reference BP per subject was 5.35/6.33 mmHg (systolic/diastolic) when the deflation algorithm was used, and 5.17/5.75 mmHg (systolic/diastolic) when the inflation algorithm was used. The VS9 Vital Signs Monitor fulfilled all the criteria in the ISO Standard. Moreover, the inflation algorithm had a shorter Measure Time (by 7-21 s) and lower maximum inflation pressure (by 9.7-22 mmHg). The VS9 Vital Signs Monitor fulfilled all the requirements of the ISO Standard (ISO 81060-2:2018) in a combined adult and pediatric population and is recommended for clinical use.

Validation of noninvasive blood pressure monitoring function of EDAN elite V5 patient monitor with reference invasive measurement according to the ISO 81060-2:2018 standard.

OBJECTIVE: To validate the noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor with reference invasive blood pressure monitoring equipment for clinical use in adults, adolescents or children according to the International Organization for Standardization (ISO) 81060-2:2018 standard. METHODS: Patients were recruited, and the ipsilateral sequential method was used for blood pressure measurement according to the standard. 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 invasive blood pressure results. RESULTS: A total of 71 patients were included in the study, with 35 and 36 patients for each iFAST and iCUFS mode, respectively. The validation results showed an average device-reference difference of -3.27 ±â€…5.60 mmHg for SBP and -0.09 ±â€…6.10 mmHg for DBP for the iFAST mode, and -2.04 ±â€…5.55 mmHg for SBP and -0.79 ±â€…5.86 mmHg for DBP for the iCUFS mode, respectively, which passed the criteria of the ISO 81060-2 : 2018 in adults, adolescents or children population for both SBP and DBP. CONCLUSION: The noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor passed all the requirements of ISO 81060-2:2018 and can be recommended for clinical use in adults, adolescents, or children.

Validation of the Raycome model M2 ambulatory blood pressure monitor in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018).

OBJECTIVE: The aim of this study was to evaluate the accuracy of the Raycome model M2 oscillometric upper-arm blood pressure (BP) monitor developed for ambulatory 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) at rest and during dynamic exercise. METHOD: 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. Three cuffs of the test device were used for arm circumference 18-22 cm (small), 22-32 cm (medium) and 32-42 cm (large). RESULTS: For the general validation study, 106 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ±â€…SD of the differences between the test device and reference BP readings was 0.5 ±â€…6.2/-0.2 ±â€…5.1 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.23/4.50 mmHg (systolic/diastolic). In the ambulatory validation study ( N  = 35), the mean difference was 0.4 ±â€…5.9/-1.1 ±â€…5.8 mmHg. The Raycome model M2 performed well against the standard in both the general and ambulatory validations and the Bland-Altman plots did not show any systematic variation in the error. CONCLUSION: These data show that the Raycome model M2 monitor meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and in the ambulatory setting, indicating its suitability for measuring BP in the general population.

Validation of the DBP-1333b upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020).

To evaluate the accuracy of the DBP-1333b upper-arm blood pressure (BP) measuring device in the adult population according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020). Subjects were recruited in the adult population. The test device was an arm-type electronic sphygmomanometer (DBP-1333b) and the reference device was a desktop sphygmomanometer (XJ11D). Using the BP data measured by the desktop sphygmomanometer as reference BP, the accuracy of the non-invasive BP module of the test device was evaluated to determine whether it met the requirements. Data from 90 individuals were analysed. According to Criterion 1, the mean difference of SBP between the test and reference device was 0.19 mmHg and the SD was 7.45 mmHg. The mean difference of DBP was -0.59 mmHg and the SD was 6.47 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, SD of SBP was 5.79 mmHg, which was less than 6.95 mmHg and met the requirements. The SD of DBP was 5.58 mmHg, which was less than 6.93 mmHg and met the requirements. It was concluded that the DBP-1333b complies with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020) and can be recommended for use by the adults.

Home Blood Pressure Monitoring.

Home blood pressure monitoring provides important diagnostic information beyond in-office blood pressure readings and offers similar results to ambulatory blood pressure monitoring. Home blood pressure monitoring involves patients independently measuring their blood pressure with an electronic device, whereas ambulatory blood pressure monitoring involves patients wearing a portable monitor for 24 to 48 hours. Although ambulatory blood pressure monitoring is the diagnostic standard for measurement, home blood pressure monitoring is more practical and accessible to patients, and its use is recommended by the U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association. Home blood pressure monitoring generally results in lower blood pressure readings than in-office measurements, can confirm the diagnosis of hypertension after an elevated office blood pressure reading, and can identify patients with white coat hypertension or masked hypertension. Best practices for home blood pressure monitoring include using an appropriately fitting upper-arm cuff on a bare arm, emptying the bladder, avoiding caffeinated beverages for 30 minutes before taking the measurement, resting for five minutes before taking the measurement, keeping the feet on the floor uncrossed and the arm supported with the cuff at heart level, and not talking during the reading. An average of multiple readings, ideally two readings in the morning and again in the evening separated by at least one minute each, is recommended for one week. Home blood pressure readings can be used in hypertension quality measures.

Hypertension in Low- and Middle-Income Countries.

In recent decades low- and middle-income countries (LMICs) have been witnessing a significant shift toward raised blood pressure; yet in LMICs, only 1 in 3 are aware of their hypertension status, and ≈8% have their blood pressure controlled. This rising burden widens the inequality gap, contributes to massive economic hardships of patients and carers, and increases costs to the health system, facing challenges such as low physician-to-patient ratios and lack of access to medicines. Established risk factors include unhealthy diet (high salt and low fruit and vegetable intake), physical inactivity, tobacco and alcohol use, and obesity. Emerging risk factors include pollution (air, water, noise, and light), urbanization, and a loss of green space. Risk factors that require further in-depth research are low birth weight and social and commercial determinants of health. Global actions include the HEARTS technical package and the push for universal health care. Promising research efforts highlight that successful interventions are feasible in LMICs. These include creation of health-promoting environments by introducing salt-reduction policies and sugar and alcohol tax; implementing cost-effective screening and simplified treatment protocols to mitigate treatment inertia; pooled procurement of low-cost single-pill combination therapy to improve adherence; increasing access to telehealth and mHealth (mobile health); and training health care staff, including community health workers, to strengthen team-based care. As the blood pressure trajectory continues creeping upward in LMICs, contextual research on effective, safe, and cost-effective interventions is urgent. New emergent risk factors require novel solutions. Lowering blood pressure in LMICs requires urgent global political and scientific priority and action.

Response to exercise-induced blood pressure elevation is blunted in wrist-cuff automated oscillometric measurement in healthy young college students.

BACKGROUND: A wrist-cuff automated oscillometric device is portable and useful for self-monitoring of blood pressure (BP) at home and outdoors when an upper arm device is not available. Although the height of the forearm in wrist BP measurement is acknowledged to be the major cause of measurement error, it remains unclear whether exercise affects subsequent wrist BP measurement. METHODS AND RESULTS: Ninety-seven healthy college students (median age of 20 years with an age range of 19 to 36 years, 70.1% males) participated in this study. Care was taken to keep the position of the wrist at a level near the upper arm level in BP measurement. At rest, BP measured by a wrist-cuff oscillometric device (Omron HEM-6183) was generally acceptable when it was compared with BP measured by an upper arm oscillometric device (Omron HEM-7130-HP) and with BP measured by the auscultatory method using a mercury sphygmomanometer. However, the ratio of systolic BP measured by oscillometric devices just after a two-step exercise test to that before exercise on the wrist (1.22 ± 0.14) was significantly lower than the ratio on the upper arm (1.27 ± 0.14), and the difference was significantly correlated with exercise-induced increase in pulse rate (Spearman's ρ = 0.23), suggesting a possible role of autonomic nerve activity in the blunted response to exercise-induced BP elevation in wrist BP measurement. CONCLUSIONS: The results indicate that the blunted response to exercise-induced BP elevation should be considered in wrist BP measurement when using a wrist-cuff oscillometric device.

Avoiding missteps in BP measurement.

Making sure a patient is seated properly is just one way to ensure an accurate measurement. But steering clear of certain methods of measurement in particular patient populations is also important.

Validation of the InBody BPBIO250 oscillometric blood pressure monitor for professional office use in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

OBJECTIVE: 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). METHODS: 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). RESULTS: 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). CONCLUSION: 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.

Validation of the Spacelabs 90227 OnTrak device according to the European and British Hypertension Societies as well as the American protocols.

OBJECTIVE: To assess the static device accuracy of the Spacelabs 90227 OnTrak according to the three most recognized validation protocols, in both adults and children. METHODS: Subjects were recruited and data gathered and analysed according to the European Society of Hypertension (ESH-IP2), the British Hypertension Society (BHS) and the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Standards Organization (ANSI/AAMI/ISO) protocols. RESULTS: The device achieved a mean difference ± SD between observers and device for SBP/DBP was 0.9 ± 7/-1.4 ± 6 mmHg (ESH-IP2) and 1.7 ± 8/-1.5/6 mmHg (BHS) Grade A/A. For the ANSI/AAMI/ISO protocol, the average device-observer difference for SBP/DBP was 0.4 ± 7/-1.5 ± 7 mmHg fulfilling the two criteria of the protocol. CONCLUSION: The Spacelabs 90227 OnTrak device achieved the criteria of all three recognised validation protocols and can therefore be recommended for clinical use as a static device.

Validation of the InBody BP170 oscillometric home blood pressure monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

OBJECTIVE: 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). METHODS: 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). RESULTS: 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). CONCLUSION: 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.

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.

OBJECTIVE: The aim of this study was to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor HL868ED for clinical use and self-measurement according to the International Protocol of the European Society of Hypertension revision 2010. METHOD: Systolic and diastolic blood pressure were measured sequentially in 43 adult Chinese (21 women, mean age 51.7 years) using a mercury sphygmomanometer (two observers) and the HL868ED device (one supervisor). A total of 99 pairs of comparisons were obtained from 43 participants for judgements in two parts with three grading phases. RESULTS: The HL868ED 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, 91/99 and 97/99, respectively, for systolic blood pressure and 85/99, 95/99 and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-four and 30 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). Three participants for systolic and one participant for diastolic blood pressure had all the three device-observer comparisons greater than 5 mmHg. CONCLUSION: The Health & Life blood pressure monitor HL868ED has passed the requirements of the International Protocol revision 2010 and hence can be recommended for blood pressure measurements in adults.

Measurement reliability of automated oscillometric blood pressure monitor in the elderly with atrial fibrillation: a systematic review and meta-analysis.

OBJECTIVES: This study aimed to identify whether automated oscillometric blood pressure monitor (AOBPM) is a reliable blood pressure (BP) measurement tool in geriatric patients with atrial fibrillation (AF) with high variability in BP and to evaluate whether it can be applied in practice. METHODS: Electronic searches were performed in databases including MEDLINE, EMBASE, the Cochrane Library, and CINAHL by using the following keywords: 'atrial fibrillation,' 'atrial flutter, 'blood pressure monitor', 'sphygmomanometer.' The QUADAS-2 was applied to assess the internal validity of selected studies. Meta-analysis was performed using RevMan 5.3 program. DESIGN: Systematic review. RESULTS: We identified 10 studies, including 938 geriatric patients with AF. We compared with the previously used BP measurement method (mainly office) and AOBPM, and the patients with AF were divided into the AF-AF (atrial fibrillation rhythm continued) and AF-SR groups (sinus rhythm recovered). The difference in the systolic BP was -3.0 mmHg [95% confidence interval (CI): -6.58 to 0.59] and -1.62 (95% CI: -6.08 to 2.84) mmHg in the AF-AF and AF-SR groups, respectively. The difference in the diastolic BP was 0.17 (95% CI: -2.90 to 3.25) mmHg and -0.23 (95% CI: -5.11 to 4.65) mmHg, respectively. CONCLUSION: This review showed that the BP difference from AOBPM compared with the auscultatory BP method was less than 5 mmHg in the elderly with AF. This difference is acceptable in clinical practice. However, AOBPM compared with invasive arterial BP in the diastolic BP was a difference of 5 mmHg or more, and so its accuracy cannot be assured.

Aortic pressure and forward and backward wave components in children, adolescents and young-adults: Agreement between brachial oscillometry, radial and carotid tonometry data and analysis of factors associated with their differences.

Non-invasive devices used to estimate central (aortic) systolic pressure (cSBP), pulse pressure (cPP) and forward (Pf) and backward (Pb) wave components from blood pressure (BP) or surrogate signals differ in arteries studied, techniques, data-analysis algorithms and/or calibration schemes (e.g. calibrating to calculated [MBPc] or measured [MBPosc] mean pressure). The aims were to analyze, in children, adolescents and young-adults (1) the agreement between cSBP, cPP, Pf and Pb obtained using carotid (CT) and radial tonometry (RT) and brachial-oscillometry (BOSC); and (2) explanatory factors for the differences between approaches-data and between MBPosc and MBPc.1685 subjects (mean/range age: 14/3-35 y.o.) assigned to three age-related groups (3-12; 12-18; 18-35 y.o.) were included. cSBP, cPP, Pf and Pb were assessed with BOSC (Mobil-O-Graph), CT and RT (SphygmoCor) records. Two calibration schemes were considered: MBPc and MBPosc for calibrations to similar BP levels. Correlation, Bland-Altman tests and multiple regression models were applied. Systematic and proportional errors were observed; errors´ statistical significance and values varied depending on the parameter analyzed, methods compared and group considered. The explanatory factors for the differences between data obtained from the different approaches varied depending on the methods compared. The highest cSBP and cPP were obtained from CT; the lowest from RT. Independently of the technique, parameter or age-group, higher values were obtained calibrating to MBPosc. Age, sex, heart rate, diastolic BP, body weight or height were explanatory factors for the differences in cSBP, cPP, Pf or Pb. Brachial BP levels were explanatory factors for the differences between MBPosc and MBPc.

QardioArm Upper Arm Blood Pressure Monitor Against Omron M3 Upper Arm Blood Pressure Monitor in Patients With Chronic Kidney Disease: A Validation Study According to the European Society of Hypertension International Protocol Revision 2010.

BACKGROUND: Hypertension is considered as a main risk factor for chronic kidney disease development and progression. Thus, the control and evaluation of this disease with new software and devices are especially important in patients who suffer from chronic kidney disease. OBJECTIVE: This study aimed to validate the QardioArm mobile device, which is used for blood pressure (BP) self-measurement in patients who suffer from chronic kidney disease, by following the European Society of Hypertension International Protocol 2 (ESH-IP2) guidelines. METHODS: A validation study was carried out by following the ESH-IP2 guidelines. A sample of 33 patients with chronic kidney disease self-measured their BP by using the QardioArm and Omron M3 Intellisense devices. Heart rate (HR), diastolic BP, and systolic BP were measured. RESULTS: The QardioArm fulfilled the ESH-IP2 validation criteria in patients who suffered from chronic kidney disease. CONCLUSIONS: Thus, this study is considered as the first validation using a wireless upper arm oscillometric device connected to an app to measure BP and HR meeting the ESH-IP2 requirements in patients who suffer from chronic kidney disease. New validation studies following the ESH-IP2 guidelines should be carried out using different BP devices in patients with specific diseases.

Assessment of a commercially available veterinary blood pressure device used on awake and anesthetized dogs.

OBJECTIVE: To compare results of a commercially available device for oscillometrically measured blood pressure (OBP) with invasively measured blood pressure (IBP) in awake and anesthetized dogs. ANIMALS: 19 adult dogs (mean ± SD body weight, 17.8 ± 7.5 kg). PROCEDURES: Blood pressures were measured in dogs while they were awake and anesthetized with isoflurane. The OBP was recorded on a thoracic limb, and IBP was simultaneously recorded from the median caudal artery. Agreement between OBP and IBP was evaluated with the Bland-Altman method. Guidelines of the American College of Veterinary Internal Medicine (ACVIM) were used for validation of the oscillometric device. RESULTS: In awake dogs, mean bias of the oscillometric device was -11.12 mm Hg (95% limits of agreement [LOA], -61.14 to 38.90 mm Hg) for systolic arterial blood pressure (SAP), 9.39 mm Hg (LOA, -28.26 to 47.04 mm Hg) for diastolic arterial blood pressure (DAP), and -0.85 mm Hg (LOA, -40.54 to 38.84 mm Hg) for mean arterial blood pressure (MAP). In anesthetized dogs, mean bias was -12.27 mm Hg (LOA, -47.36 to 22.82 mm Hg) for SAP, -3.92 mm Hg (LOA, -25.28 to 17.44 mm Hg) for DAP, and -7.89 mm Hg (LOA, -32.31 to 16.53 mm Hg) for MAP. The oscillometric device did not fulfill ACVIM guidelines for the validation of such devices. CONCLUSIONS AND CLINICAL RELEVANCE: Agreement between OBP and IBP results for awake and anesthetized dogs was poor. The oscillometric blood pressure device did not fulfill ACVIM guidelines for validation. Therefore, clinical use of this device cannot be recommended.

An Ambulatory Blood Pressure Monitor Mobile Health System for Early Warning for Stroke Risk: Longitudinal Observational Study.

BACKGROUND: Stroke, as a leading cause of death around the globe, has become a heavy burden on our society. Studies show that stroke can be predicted and prevented if a person's blood pressure (BP) status is appropriately monitored via an ambulatory blood pressure monitor (ABPM) system. However, currently there exists no efficient and user-friendly ABPM system to provide early warning for stroke risk in real-time. Moreover, most existing ABPM devices measure BP during the deflation of the cuff, which fails to reflect blood pressure accurately. OBJECTIVE: In this study, we sought to develop a new ABPM mobile health (mHealth) system that was capable of monitoring blood pressure during inflation and could detect early stroke-risk signals in real-time. METHODS: We designed an ABPM mHealth system that is based on mobile network infrastructure and mobile apps. The proposed system contains two major parts: a new ABPM device in which an inflation-type BP measurement algorithm is embedded, and an abnormal blood pressure data analysis algorithm for stroke-risk prediction services at our health data service center. For evaluation, the ABPM device was first tested using simulated signals and compared with the gold standard of a mercury sphygmomanometer. Then, the performance of our proposed mHealth system was evaluated in an observational study. RESULTS: The results are presented in two main parts: the device test and the longitudinal observational studies of the presented system. The average measurement error of the new ABPM device with the inflation-type algorithm was less than 0.55 mmHg compared to a reference device using simulated signals. Moreover, the results of correlation coefficients and agreement analyses show that there is a strong linear correlation between our device and the standard mercury sphygmomanometer. In the case of the system observational study, we collected a data set with 88 features, including real-time data, user information, and user records. Our abnormal blood pressure data analysis algorithm achieved the best performance, with an area under the curve of 0.904 for the low risk level, 0.756 for the caution risk level, and 0.912 for the high-risk level. Our system enables a patient to be aware of their risk in real-time, which improves medication adherence with risk self-management. CONCLUSIONS: To our knowledge, this device is the first ABPM device that measures blood pressure during the inflation process and has obtained a government medical license. Device tests and longitudinal observational studies were conducted in Peking University hospitals, and they showed the device's high accuracy for BP measurements, its efficiency in detecting early signs of stroke, and its efficiency at providing an early warning for stroke risk.

Validation of the YuWell YE680B upper-arm blood pressure monitor in adults according to the ANSI/AAMI/ISO 81060-2: 2013 standard.

OBJECTIVE: To evaluate the accuracy of the YuWell YE680B oscillometric upper-arm blood pressure monitor for clinic and home blood pressure measurements in adults according to the American National Standards Institute/the Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard. METHOD: Eighty-five subjects (male 46 and female 39) with a mean age of 44.6 years were recruited to fulfill the age, sex, blood pressure, and cuff distribution criteria of the ANSI/AAMI/ISO standard in the general population using the same arm sequential blood pressure measurement method. Two differently-sized cuffs were used for arm circumferences 22-32 cm (medium) and 22-45 cm (large), respectively, for the test device, and for arm circumferences ≤32 cm (standard) and >32 cm (large), respectively, for the mercury sphygmomanometer. RESULTS: A total of 255 comparison pairs were obtained for analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference systolic/diastolic blood pressure readings was -2.2 ± 7.2/-3.9 ± 5.2 mmHg. For validation criterion 2, the SD of the averaged systolic/diastolic blood pressure differences between the test device and reference blood pressure per subject was 5.70/4.67 mmHg. CONCLUSION: The automated upper-arm blood pressure monitor YuWell YE680B has passed the requirements of the ANSI/AAMI/ISO81060-2:2013 standard, and hence can be recommended for blood pressure measurement in the general population.