Engagement in mHealth-Prompted Self-Measured Blood Pressure Monitoring Among Participants Recruited From a Safety-Net Emergency Department: Secondary Analysis of the Reach Out Trial.

Background: Hypertension, a key modifiable risk factor for cardiovascular disease, is more prevalent among Black and low-income individuals. To address this health disparity, leveraging safety-net emergency departments for scalable mobile health (mHealth) interventions, specifically using text messaging for self-measured blood pressure (SMBP) monitoring, presents a promising strategy. This study investigates patterns of engagement, associated factors, and the impact of engagement on lowering blood pressure (BP) in an underserved population. Objective: We aimed to identify patterns of engagement with prompted SMBP monitoring with feedback, factors associated with engagement, and the association of engagement with lowered BP. Methods: This is a secondary analysis of data from Reach Out, an mHealth, factorial trial among 488 hypertensive patients recruited from a safety-net emergency department in Flint, Michigan. Reach Out participants were randomized to weekly or daily text message prompts to measure their BP and text in their responses. Engagement was defined as a BP response to the prompt. The k-means clustering algorithm and visualization were used to determine the pattern of SMBP engagement by SMBP prompt frequency-weekly or daily. BP was remotely measured at 12 months. For each prompt frequency group, logistic regression models were used to assess the univariate association of demographics, access to care, and comorbidities with high engagement. We then used linear mixed-effects models to explore the association between engagement and systolic BP at 12 months, estimated using average marginal effects. Results: For both SMBP prompt groups, the optimal number of engagement clusters was 2, which we defined as high and low engagement. Of the 241 weekly participants, 189 (78.4%) were low (response rate: mean 20%, SD 23.4) engagers, and 52 (21.6%) were high (response rate: mean 86%, SD 14.7) engagers. Of the 247 daily participants, 221 (89.5%) were low engagers (response rate: mean 9%, SD 12.2), and 26 (10.5%) were high (response rate: mean 67%, SD 8.7) engagers. Among weekly participants, those who were older (>65 years of age), attended some college (vs no college), married or lived with someone, had Medicare (vs Medicaid), were under the care of a primary care doctor, and took antihypertensive medication in the last 6 months had higher odds of high engagement. Participants who lacked transportation to appointments had lower odds of high engagement. In both prompt frequency groups, participants who were high engagers had a greater decline in BP compared to low engagers. Conclusions: Participants randomized to weekly SMBP monitoring prompts responded more frequently overall and were more likely to be classed as high engagers compared to participants who received daily prompts. High engagement was associated with a larger decrease in BP. New strategies to encourage engagement are needed for participants with lower access to care.

Design and validation of dual-point time-differentiated photoplethysmogram (2PPG) wearable for cuffless blood pressure estimation.

BACKGROUND & OBJECTIVES: Measurement of blood pressure (BP) in ambulatory patients is crucial for at high-risk cardiovascular patients. A non-obtrusive, non-occluding device that continuously measures BP via photoplethysmography will enable long-term ambulatory assessment of BP. The aim of this study is to validate the metasense 2PPG cuffless wearable design for continuous BP estimation without ECG. METHODS: A customized high-speed electronic optical sensor architecture with laterally spaced reflectance pulse oximetry was designed into a simple unobtrusive low-power wearable in the form of a watch. 78 volunteers with a mean age of 32.72 ± 7.4 years (21 to 64), 51% male, 49% female were recruited with ECG-2PPG signals acquired. The fiducial features of the 2PPG morphologies were then attributed to the estimator. A 9-1 K-fold cross-validation was applied in the ML. RESULTS: The correlation for PTT-SBP was 0.971 and for PTT-DBP was 0.954. The mean absolute error was 3.167±1.636 mmHg for SBP and 6.4 ± 3.9 mm Hg for DBP. The ambulatory estimate for SBP and DBP for an individual over 3 days with 8-hour recordings was 0.70-0.81 for SBP and 0.42-0.51 for DBP with a ± 2.65 mmHg for SBP and ±2.02 mmHg for DBP. For SBP, 98% of metasense measurements were within 15 mm Hg and for DBP, 91% of metasense measurements were within 10 mmHg CONCLUSIONS: The metasense device provides continuous, non-invasive BP estimations that are comparable to ambulatory BP meters. The portability and unobtrusiveness of this device, as well as the ability to continuously measure BP could one day enable long-term ambulatory BP measurement for precision cardiovascular therapeutic regimens.

Measurement of arterial occlusion pressure using straight and curved blood flow restriction cuffs.

Arterial occlusion pressure (AOP) is influenced by the characteristics of the cuff used to measure AOP. Doppler ultrasound was used to measure AOP of the brachial and superficial femoral arteries using straight and curved blood flow restriction cuffs in 21 males and 21 females. Vessel diameter and blood flow were evaluated as independent predictors of AOP. Overall, there were no significant differences in AOP when using the straight and curved cuffs in the brachial (129 mmHg vs. 128 mmHg) or superficial femoral artery (202 mmHg vs. 200 mmHg), respectively. Overall, AOP was greater (p < 0.05) in males than in females in the arm (135 mmHg, 123 mmHg) and leg (211 mmHg, 191 mmHg). Brachial (0.376 mm, 0.323 mm) and superficial femoral (0.547 mm, 0.486 mm) arteries were larger (p = 0.016) in males than in females, respectively. Systolic blood pressure (SBP) and arm circumference were predictive of brachial artery AOP, whereas SBP, diastolic blood pressure, thigh circumference, and vessel diameter were predictive of superficial femoral artery AOP. Straight and curved cuffs are efficacious in the measurement of AOP in the arm and leg. Differences in vessel size may contribute to sex differences in AOP but this requires further investigation.

Effect of limb and cuff positioning on measurement of arterial blood pressure with an oscillometry device (PetMAP) in anaesthetized cats.

Arterial blood pressure (ABP) is often measured with oscillometry during anaesthesia. Changing the height of the measuring cuff with respect to the level of the heart is known to affect oscillometry accuracy in some species; however, this effect has not been investigated in cats. The objective of this study was to determine the effects of raising and lowering the measuring cuff from standard position (level of the heart) on ABP, measured with PetMAP, in anaesthetised cats. ABP readings were obtained from 29 cats with the cuff at standard position (baseline), and 5 cm above and below the heart. The end-tidal isoflurane concentrations were maintained constant during data acquisition. There were no differences between baseline values and those measured below the heart, while ABP measured above the heart was consistently lower than baseline for both the thoracic and pelvic limbs (P < 0.001), with absolute differences of 8.2 (2.5 - 14) mmHg and 6.5 (3.0 - 15.0) mmHg, respectively. Systolic ABP readings at the pelvic limb were consistently higher than those at the thoracic limb at standard position (112 ± 26 versus 103 ± 21 mmHg, p = 0.010), above (106 ± 22 versus 95 ± 20 mmHg, p = 0.003), and below the heart (116 ± 26 versus 107 ± 22 mmHg, p = 0.011). This study shows that raising the cuff by 5 cm above the heart, which may become necessary during procedural positioning, results in clinically significant underestimation of ABP measured with PetMAP.

Flexible Strain Sensors Based on an Interlayer Synergistic Effect of Nanomaterials for Continuous and Noninvasive Blood Pressure Monitoring.

The continuous, noninvasive monitoring of human blood pressure (BP) through the accurate detection of pulse waves has extremely stringent requirements on the sensitivity and stability of flexible strain sensors. In this study, a new ultrasensitive flexible strain sensor based on the interlayer synergistic effect was fabricated through drop-casting and drying silver nanowires and graphene films on polydimethylsiloxane substrates and was further successfully applied for continuous monitoring of BP. This strain sensor exhibited ultrahigh sensitivity with a maximum gauge factor of 34357.2 (∼700% sensitivity enhancement over other major sensors), satisfactory response time (∼85 ms), wide strange range (12%), and excellent stability. An interlayer fracture mechanism was proposed to elucidate the working principle of the strain sensor. The real-time BP values can be obtained by analyzing the relationship between the BP and the pulse transit time. To verify our strain sensor for real-time BP monitoring, our strain sensor was compared with a conventional electrocardiogram-photoplethysmograph method and a commercial cuff-based device and showed similar measurement results to BP values from both methods, with only minor differences of 0.693, 0.073, and 0.566 mmHg in the systolic BP, diastolic BP, and mean arterial pressure, respectively. Furthermore, the reliability of the strain sensors was validated by testing 20 human subjects for more than 50 min. This ultrasensitive strain sensor provides a new pathway for continuous and noninvasive BP monitoring.

Evaluation of the oscillometric method for noninvasive blood pressure measurement during cuff deflation and cuff inflation with reference to intra-arterial blood pressure.

There is little quantitative clinical data available to support blood pressure measurement accuracy during cuff inflation. In this study of 35 male and 5 female lightly anaesthetized subjects aged 64.1 ±â€Š9.6 years, we evaluate and compare the performance of both the oscillometric ratio and gradient methods during cuff deflation and cuff inflation with reference to intra-arterial measurements. We show that the oscillometric waveform envelopes (OWE), which are key to both methods, exhibit significant variability in both shape and smoothness leading to at least 15% error in the determination of mean pressure (MP). We confirm the observation from our previous studies that K1 Korotkoff sounds underestimate systolic blood pressure (SBP) and note that this underestimation is increased during cuff inflation. The estimation of diastolic blood pressure (DBP) is generally accurate for both the ratio and the gradient method, with the latter showing a significant increase during inflation. Since the gradient method estimates SBP and DBP from points of maximum gradient on each OWE recorded, it may offer significant benefits over the ratio method. However, we have shown that the ratio method can be optimized for any data set to achieve either a minimum mean error (ME) of close to 0 mmHg or minimum root mean square error (RMSE) with standard deviation (SD) of <5.0 mmHg. We conclude that whilst cuff inflation may offer some advantages, these are neither significant nor substantial, leaving as the only benefit, the potential for more rapid measurement and less patient discomfort.

Hemodynamic Bedside Monitoring Instrument with Pressure and Optical Sensors: Validation and Modality Comparison.

Results from two independent clinical validation studies for measuring hemodynamics at the patient's bedside using a compact finger probe are reported. Technology comprises a barometric pressure sensor, and in one implementation, additionally, an optical sensor for photoplethysmography (PPG) is developed, which can be used to measure blood pressure and analyze rhythm, including the continuous detection of atrial fibrillation. The capabilities of the technology are shown in several form factors, including a miniaturized version resembling a common pulse oximeter to which the technology could be integrated in. Several main results are presented: i) the miniature finger probe meets the accuracy requirements of non-invasive blood pressure instrument validation standard, ii) atrial fibrillation can be detected during the blood pressure measurement and in a continuous recording, iii) a unique comparison between optical and pressure sensing mechanisms is provided, which shows that the origin of both modalities can be explained using a pressure-volume model and that recordings are close to identical between the sensors. The benefits and limitations of both modalities in hemodynamic monitoring are further discussed.

Non-Invasive Hemodynamic Monitoring System Integrating Spectrometry, Photoplethysmography, and Arterial Pressure Measurement Capabilities.

Minimally invasive and non-invasive hemodynamic monitoring technologies have recently gained more attention, driven by technological advances and the inherent risk of complications in invasive techniques. In this article, an experimental non-invasive system is presented that effectively combines the capabilities of spectrometry, photoplethysmography (PPG), and arterial pressure measurement. Both time- and wavelength-resolved optical signals from the fingertip are measured under external pressure, which gradually increased above the level of systolic blood pressure. The optical channels measured at 434-731 nm divided into three groups separated by a group of channels with wavelengths approximately between 590 and 630 nm. This group of channels, labeled transition band, is characterized by abrupt changes resulting from a decrease in the absorption coefficient of whole blood. External pressure levels of maximum pulsation showed that shorter wavelengths (<590 nm) probe superficial low-pressure blood vessels, whereas longer wavelengths (>630 nm) probe high-pressure arteries. The results on perfusion indices and DC component level changes showed clear differences between the optical channels, further highlighting the importance of wavelength selection in optical hemodynamic monitoring systems. Altogether, the results demonstrated that the integrated system presented has the potential to extract new hemodynamic information simultaneously from macrocirculation to microcirculation.

Measuring blood pressure from Korotkoff sounds as the brachial cuff inflates on average provides higher values than when the cuff deflates.

Objectives. In this study, we test the hypothesis that if, as demonstrated in a previous study, brachial arteries exhibit hysteresis as the occluding cuff is deflated and fail to open until cuff pressure (CP) is well below true intra-arterial blood pressure (IAPB), estimating systolic (SBP) and diastolic blood pressure (DBP) from the presence of Korotkoff sounds (KS) as CP increases may eliminate these errors and give more accurate estimates of SBP and DBP relative to IABP readings.Approach. In 62 subjects of varying ages (45.1 ± 19.8, range 20.6-75.8 years), including 44 men (45.3 ± 19.4, range 20.6-75.8 years) and 18 women (44.4 ± 21.4, range 20.9-75.3 years), we sequentially recorded SBP and DBP both during cuff inflation and cuff deflation using KS.Results. There was a significant (p< 0.0001) increase in SBP from 122.8 ± 13.2 to 127.6 ± 13.0 mmHg and a significant (p= 0.0001) increase in DBP from 70.0 ± 9.0 to 77.5 ± 9.7 mmHg. Of the 62 subjects, 51 showed a positive increase in SBP (0-14 mmHg) and 11 subjects showed a reduction (-0.3 to -7 mmHg). The average differences for SBP and DBP estimates derived as the cuff inflates and those derived as the cuff deflates were 4.8 ± 4.6 mmHg and 2.5 ± 4.6 mmHg, not dissimilar to the differences reported between IABP and non-invasive blood pressure measurements. Although we could not develop multiparameter linear or non-linear models to explain this phenomenon we have clearly demonstrated through ANOVA tests that both body mass index (BMI) and pulse wave velocity are implicated, supporting the hypothesis that the phenomenon is associated with age, higher BMI and stiffer arteries.Significance. The implications of this study are that brachial sphygmomanometry carried out during cuff inflation could be more accurate than measurements carried out as the cuff deflates. Further research is required to validate these results with IAPB measurements.

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.

Comparisons of an automated oscillometric device with a hybrid manual auscultatory device for the Korea National Health and Nutrition Examination Survey.

This study evaluated an oscillometric device (OD), Microlife WatchBP Office AFIB, and a hybrid manual auscultatory device (AD), Greenlight 300TM, to determine a suitable blood pressure (BP) measurement device for the Korea National Health and Nutrition Examination Survey in a mercury-free context. Adhering to the 2018 Universal Standard's suggested consensus, the study involved 800 subjects (mean age 51.2 ± 17.5 years; 44.3% male), who underwent triplicate BP measurements following 5 min of rest in a randomized order (OD-first: 398 participants; AD-first: 402 participants). BP difference was calculated as OD value minus AD value, with results stratified by measurement sequence. The overall BP difference and tolerable error probability were -1.1 ± 6.5/-2.6 ± 4.9 mmHg and 89.2%/92.5% for systolic/diastolic BP (SBP/DBP), respectively. Lin's concordance correlation coefficient was 0.907/0.844 for SBP/DBP (OD-first/AD-first: 0.925/0.892 for SBP, 0.842/0.845 for DBP). The overall agreement for hypertension (BP ≥ 140 and/or 90 mmHg) was 0.71 (p < 0.0001), and the OD underestimated the overall hypertension prevalence by 5.1%. Analysis of the AD-first data revealed a lower level of agreement compared to the OD-first data; however, the observed blood pressure difference adhered to Criterion 1 of the 2018 Universal Standard. Microlife met the Criterion 1 of 2018 Universal Standard but underestimated the prevalence of hypertension. The BP discrepancy increased with higher BP levels, male sex, and smaller AC. With increasing age, the discrepancy decreased for SBP and increased for DBP.

Development of beat-by-beat blood pressure monitoring device and nocturnal sec-surge detection algorithm.

The nocturnal blood pressure (BP) surge in seconds (sec-surge) is defined as a brief, acute transient BP elevation over several tens of seconds, triggered by obstructive sleep apnea (OSA) and sympathetic hyperactivity. Sec-surge imposes a significant strain on the cardiovascular system, potentially triggering cardiovascular events. Quantitative evaluation of sec-surge level could be valuable in assessing cardiovascular risks. To accurately measure the detailed sec-surge, including its shape as BP rises and falls, we developed a beat-by-beat (BbB) BP monitoring device using tonometry. In addition, we developed an automatic sec-surge detection algorithm to help identify sec-surge cases in the overnight BbB BP data. The device and algorithm successfully detected sec-surges in patients with OSA. Our results demonstrated that sec-surge was associated with left ventricular hypertrophy and arterial stiffness independently of nocturnal BP level or variability. Sec-surge would be worth monitoring for assessing cardiovascular risks, in addition to nocturnal BP level. Nocturnal blood pressure (BP) surge in seconds (sec-surge) places heavy load on the cardiovascular system and can trigger cardiovascular events. To identify sec-surges, we developed a beat-by-beat BP monitoring device and a sec-surge detection algorithm. Furthermore, sec-surge was more related to cardiovascular risks than conventional nocturnal BP parameters.

A flexible multimodal pulse sensor for wearable continuous blood pressure monitoring.

Monitoring of arterial blood pressure via cuffless pulse waveform measurement at the wrist has an important clinical value for the early diagnosis and prevention of cardiovascular disease. However, accurate measurement of the radial pulse waveform is challenging owing to its subtle, wideband, and preload-dependent variation characteristics. Evidence shows that uncertainties or variations of wearing pressure and skin temperature can cause artifact signals in wrist pulse measurements, thus degrading blood pressure estimate accuracy and hindering precise clinical diagnosis. Herein, we report a flexible multisensory pulse sensor utilizing natural piezo-thermic transduction of human skin in conjunction with thin-film thermistors for the accurately measuring radial artery pulse waves with high fidelity and good anti-artifact performance. The flexible pulse sensor achieved a wide pressure measuring range (228.2 kPa), low detection limit (4 Pa), good linearity (R2 = 0.999), low hysteresis (2.45%), fast response (88 ms), and good durability and stability, thereby enabling accurate pulse measurement with high fidelity. The pulse sensor also monolithically integrated the simultaneous detections of skin temperature and wearing pressure for resisting artifact effects in pulse measurements. Through the fusion of multiple features extracted from the pulse waveform, wearing pressure, skin temperature and user's personal physical characteristics using an efficient multilayer perceptron, blood pressure is accurately estimated and good generalizability is achieved.

Postpartum Remote Blood Pressure Monitoring Using a Mobile App in Women with a Hypertensive Disorder of Pregnancy.

BACKGROUND: Hypertensive disorders of pregnancy affect approximately 15% of pregnancies in the United States and are a leading cause of postpartum readmissions. Morbidity due to hypertension may be higher in the first several weeks postpartum. The ability to monitor blood pressure and intervene in the postpartum period is critical to reducing morbidity and mortality. LOCAL PROBLEM: At WellSpan Health, hypertensive disorders were increasing and a leading cause of severe maternal morbidity and readmission. INTERVENTIONS: A remote blood pressure monitoring app called BabyScripts™ myBloodPressure was implemented in September 2020. Prior to discharge postpartum, all patients with a diagnosis of a hypertensive disorder of pregnancy were given an automatic blood pressure cuff and instructions on how to monitor and track their blood pressure daily in the app. RESULTS: A total of 1,260 patients were enrolled in the BabyScripts™ myBloodPressure module between September 2020 and July 2022 across five maternity hospitals. Of those enrolled 74% ( n = 938) entered seven or more blood pressures, and of those who entered at least one blood pressure 9% ( n = 107) entered at least one critical range blood pressure ( ≥ 150 mmHg systolic and or ≥ 100 mmHg diastolic). CONCLUSION: Most women enrolled in the app were highly engaged and entered seven or more readings. Patients with critical blood pressures were identified; thus, the program has the potential to identify those at risk of severe complications. Barriers should be removed, and remote patient monitoring considered as a solution to improve postpartum assessment in patients with hypertensive disorders of pregnancy.

The 10 Hz dynamic response of a fluid-filled pressure monitoring system is a novel alternative to the fast flush test and indicative of unacceptable systolic pressure overshoot.

The standard method for qualitatively evaluating the dynamic response is to see if the gain of the amplitude spectrum curve approaches 1 (input signal = output signal) over the frequency band of the blood pressure waveform. In a previous report, Watanabe reported that Gardner's natural frequency and damping coefficient, which are widely used as evaluation methods, do not reflect the dynamic response of the circuit. Therefore, new parameters for evaluating the dynamic response of pressure monitoring circuits were desired. In this study, arterial pressure catheters with length of 30, 60, 150, and 210 cm were prepared, and a blood pressure wave calibrator, two pressure monitors with analog output and a personal computer were used to analyze blood pressure monitoring circuits. All data collection and analytical processes were performed using step response analysis program. The gain at 10 Hz was close to 1 and the systolic blood pressure difference was small in the short circuits (30 cm, 60 cm), and the gain at 10 Hz was 1.3-1.5 in the 150 cm circuit and over 1.7 in the 210 cm circuit. The difference in systolic blood pressure increased in proportion to the length of the circuit. It could also be inferred that the gain at 10 Hz should be less than 1.2 to meet a clinically acceptable blood pressure difference. In conclusion, the gain at 10 Hz is sufficiently useful as an indicator to determine the correct systolic blood pressure.

Accuracy of the KOROT P3 Accurate automated auscultatory blood pressure measuring device for professional use in people with extra-large arms.

OBJECTIVE: To determine the accuracy of the KOROT P3 Accurate (previously InBody BPBIO480KV) monitor, an automated auscultatory blood pressure (BP) measuring device developed for professional use, in people with extra-large arms according to the ISO81060-2 2018 protocol. METHODS: The KOROT P3 Accurate was tested in 37 subjects with upper-arm circumference ranging from >42 to 53 cm using a mercury sphygmomanometer coupled to a 20 × 40 cm tronco-conical cuff as the reference standard. RESULTS: The mean BP difference between the device and the observers' reference measurements was 1.2 ±â€…2.0 mmHg for systolic BP and 1.0 ±â€…2.0 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ±â€…8 mmHg). Also criterion 2 was satisfied being the standard deviations ± 1.7 mmHg for systolic BP and ± 1.6 for diastolic BP, well below the maximum values required by the protocol (±6.84/6.87 mmHg). Scatterplots of device-reference systolic and diastolic BP differences showed similar accuracy across the range of participants' BP, arm circumference and upper-arm slant angle. CONCLUSIONS: These data show that the KOROT P3 Accurate monitor satisfied the ISO 81060-2:2018 standard requirements in a special population of people with extra-large arms ranging from >42 to 53 cm.

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 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.