Validation of Telli BP01 Oscillometric Blood Pressure Monitor According to AAMI/ESH/ISO Standard

Validation of Telli BP01 Oscillometric Blood Pressure Monitor According to AAMI/ESH/ISO Standard | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Validation of Telli BP01 Oscillometric Blood Pressure Monitor According to AAMI/ESH/ISO Standard Kazumasa Manabe, Lin Sheng Chen, Tianyu Wang, Gautam Vennapu, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6456897/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract The aim of the study was to evaluate the accuracy of a home-based oscillometric upper-arm blood pressure (BP) monitor (Telli BP01) in accordance with the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Participants were recruited to fulfill the age, sex, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard. Both the test device and the aneroid sphygmomanometer (observer BP) were connected to the BP cuff to measure BP simultaneously at rest and during maximal static hand grip (SHG). Ninety-two participants were recruited, and 85 were analyzed. Eleven participants were asked to perform SHG during the test. For validation Criterion 1, the mean ± SD of the differences (the test device minus observer BP) for all BP readings was − 1.8 ± 6.6/-3.7 ± 5.7 mmHg (systolic/diastolic). For validation Criterion 2, the SD of all participants' averaged BP differences (the test device minus observer BP per participant) was 5.5/4.9 mmHg (systolic/diastolic). Both criteria were fulfilled in the present validation study. In conclusion, the Telli BP01 BP monitor fulfilled the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and can be recommended for use at home. Health sciences/Health care/Diagnosis Biological sciences/Physiology/Ageing Health sciences/Diseases/Cardiovascular diseases/Hypertension Health sciences/Health care/Disease prevention/Preventive medicine Health sciences/Risk factors accuracy upper-arm blood pressure measurement validation automated oscillometric Figures Figure 1 Figure 2 INTRODUCTION The measurement of blood pressure (BP) is essential for evaluating cardiovascular health ( 1 ). Early and accurate diagnosis of hypertension is needed to properly control hypertension and the subsequent chronic degenerative diseases, including stroke, ischemic heart disease, renal dysfunction, and dementia ( 1 , 2 ). Inaccurate BP measurement to over or underestimate true BP would result in misdiagnosis of cardiovascular risks, or an increased risk of overmedication ( 3 , 4 ). Thus, the development of an accurate and reliable BP measurement device would be essential to curb this obstacle. In this context, home BP monitoring is particularly ideal as it provides more accurate BP readings while avoiding white-coat hypertension and identifying masked hypertension ( 5 ). A new automated BP monitor, Telli BP01 (Telli Health, Miami, USA) has been developed for home-based use. This device is user-friendly to measure and collect BP at home in cloud storage via the mobile communication network, making it easier to manage BP changes in daily life. The accuracy of the BP monitoring device is one of the most important features. The Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH), and the International Organization for Standardization (ISO) committees have established a standardized protocol for validating noninvasive blood pressure devices, outlined in the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018 + Amd.1:2020) ( 6 ). Further, ESH recommends various situation tests for evaluating different aspects of BP changes, such as during exercise, to validate the accuracy of increasing BP ( 7 ). This study aims to validate the accuracy of the Telli BP01. The validation was conducted according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) with modifications tailored for general population use. METHODS Participants According to the AAMI/ESH/ISO Universal Standard ( 6 ) for a general population validation study of a BP monitor, valid recordings from at least 85 participants were required. Inclusion criteria for participants were: ( 1 ) age > 12 years and ( 2 ) voluntarily agreed to participate in the study and provided informed consent. Exclusion criteria for participants were: ( 1 ) arm circumference 42 cm, ( 2 ) arrhythmias that affect BP measurements like atrial fibrillation, and ( 3 ) pregnancy. The study was approved by the institutional review board at the University of Texas at Austin (STUDY00005948) and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all study participants. The BP measurement devices The test device, Telli BP01, is an automated oscillometric upper-arm BP monitor developed for home use. The device has a medium-size cuff (cuff size: 60 x 15 cm, bladder size: 24 x 13 cm) for an arm circumference of 22–42 cm, which was used according to the manufacturer’s instructions. Two identical devices were provided by the manufacturer for the validation study, together with a written declaration that they were standard production models. One of them was randomly selected for the validation procedure. The aneroid sphygmomanometers (V223, Labtron, Atlanta, USA), which had been calibrated before the study initiation were used for simultaneous reference auscultatory BP measurements by two observers using a dual-head teaching stethoscope (Littmann Classic II SE, 3M™, Minnesota, USA). Both observers identified the first and fifth Korotkoff sounds as systolic and diastolic BP, respectively. Procedure The measurements were conducted by a supervisor and two trained observers who were experienced in BP assessments. BP was simultaneously measured from the same arm, which was demonstrated as the best method for assessing device accuracy ( 8 , 9 ). A Y-connector was used to split the connection from the test cuff to both the test device and the aneroid sphygmomanometer (observer BP). Air to inflate the cuff was delivered by the test device and was simultaneously monitored by the sphygmomanometer. The initial testing phase involved a single baseline measurement, consisting of two observers’ readings and a test device reading. Observers’ readings are recorded concurrently with corresponding test device readings. The observers were blinded to each other’s readings and the test device results. The supervisor monitored the test device measurements and verified the accuracy of the observers' recordings to ensure agreement within ≤ 3 mmHg for simultaneous systolic and diastolic BP readings. At least three pairs of simultaneous measurements were taken and used for analysis. In instances where the observers' readings disagreed, additional pairs of measurements were taken. Further, systolic BP difference ≥ 12 mmHg and diastolic BP difference ≥ 8 mmHg between any two observer BP readings of the four were also retested. Two observers' readings were averaged. To examine the device's response in the situation which BP rises during daily activities such as isometric exercise (e.g., carrying a grocery bag) ( 7 , 10 ), a subset of participants (n = 11) were asked to perform the voluntary maximal static handgrip exercises through BP measurement to induce relatively higher BP (≥ 140 mmHg) on the contralateral hand during BP measurement. Analyses According to the requirements of the AAMI/ESH/ISO universal standard (ISO 81060-2:2018 + Amd.1:2020) ( 6 ), the test device must meet two criteria to pass the standard. For Criterion 1, the mean of BP difference (test device minus observer BP) for all pairs of measurements must be within ± 5 mmHg, and its SD must be ≤ 8 mmHg for both systolic and diastolic BP. For Criterion 2, the SD of all participants' mean of BP differences (the average of test device minus observer BP per participant) must be within a threshold specified in the table in the AAMI/ESH/ISO universal standard (ISO 81060-2:2018 + Amd.1:2020) ( 6 ). Values are expressed as means ± standard deviation (SD). The Bland-Altman analyses of agreement were conducted to observe the relative differences between the test devices and the observer measurements. Pearson’s correlation analyses were conducted to determine the relationships between the two different methods. P < 0.05 was considered significant for all analyses. RESULTS Of the 92 individuals initially recruited, seven were excluded from the study because the device could not measure their BP. All of these errors the device showed were about inflation and were in participants with arm circumferences over 37 cm. This resulted in a final sample size of 85 participants, yielding a total of 255 data points. The handgrip exercise was applied to 11 participants for 33 data points. Participant characteristics are detailed in Table 1 . All participants met the predefined criteria for age, sex, arm circumference, and BP distribution (Tables 1 and 2 ). The mean ± SD of BP differences for all 255 individual data points was − 1.8 ± 6.6/-3.7 ± 5.7 mmHg (systolic/diastolic BP), which fulfilled Criterion 1. The SD of individual 85 participants averaged BP difference showed that systolic BP was 5.5 mmHg (must be ≤ 6.7 mmHg) and diastolic BP was 4.9 mmHg (must be ≤ 5.8 mmHg), which met Criterion 2. Bland–Altman scatterplots of systolic BP and diastolic BP differences between the test and reference devices are shown in Fig. 1 . Table 1 Selected participant characteristics Characteristics Mean ± SD Range Male/Female, n 43/42 Age, years 32 ± 15 18–75 Arm circumference, cm 30 ± 5 22–39 Systolic BP, mmHg 123 ± 17 96–164 Diastolic BP, mmHg 74 ± 15 52–123 BP = blood pressure Table 2 Distribution of arm circumference and blood pressure (BP) of the participants Variable n (%) Arm circumferences (cm) 22.0-31.9 50 (59) 32.0–42.0 35 (41) 22.0-26.9 31 (36) 37.0–42.0 18 (21) Systolic BP (mmHg) ≤100 25 ( 10 ) ≥160 13 ( 5 ) ≥140 51 (20) Diastolic BP (mmHg) ≤60 14 ( 5 ) ≥100 33 (13) ≥85 72 (28) Figure 2 shows that both systolic and diastolic BP obtained with the observer BP were strongly associated with the test device BP (both r = 0.93, p < 0.001), supporting the Bland-Altman analysis results. DISCUSSION This study validated the accuracy of the home-based Telli BP01 BP monitoring device in the general adult population on AAMI/ESH/ISO universal standard (ISO 81060-2:2018 + Amd.1:2020) ( 6 ). Instead of the sequential method, we adopted the simultaneous method to measure BP by connecting the cuff with both the device and the reference sphygmomanometer in the current study. This method is ideal because any differences ascribable to factors other than the two measurement methods are eliminated ( 8 , 9 ). Simultaneous comparison is often hindered by insufficient cuff inflation, rapid deflation, and excessive deflation rates in automated devices ( 8 ). However, this device overcame these limitations, allowing for more accurate comparisons. About 90% of all data points during handgrip exercise were within the ± 1.96 SD range in the study. ESH recommends various situation tests for evaluating different aspects of BP variability, such as during exercise to validate the accuracy of increasing BP [7]. Isometric muscle contraction with increasing BP is often seen in daily activity (e.g., holding a shopping bag, etc.) ( 11 ). Thus, the device might be able to be used with the same accuracy even when or after blood pressure is elevated in daily life activity. Seven participants who could not be measured were in the upper quarter of the cuff range. One possible reason that the test device could not measure may be due to the connection of the sphygmomanometer between the device and the cuff. The pump in the device has a maximum speed and the algorithm in the device expects a pressure after an amount of time. It was possible that the combination of a large arm and the blood pressure monitor required more air than the upper limit, causing the algorithm to stall. CONCLUSION The Telli BP01 met the validation criteria of AAMI/ESH/ ISO universal standard (ISO 81060-2:2018 + Amd.1:2020) and can therefore be recommended for home BP measurement in general adults. Declarations DISCLOSURES The Telli BP01 device was provided by Telli Health, Miami, USA. FUNDING The preparation of this manuscript was partially supported by funding from Japan Society for the Promotion of Science (23KJ1618, held by K.M.). AUTHOR CONTRIBUTION The study design, participant recruitment, and data collection were completed independently by the investigators of the University of Texas at Austin. K.M. and H.T. conceived and designed the study; all authors performed experiments; K.M. analyzed the data; K.M. prepared figures; K.M. drafted the manuscript; all authors reviewed and edited the manuscript; and all authors approved the final version of the manuscript. ACKNOWLEDGEMENTS We would like to thank Douglas Blakely and Paul Nederveen, who gave us some suggestions and helped with the content related to the Telli BP01 device. DATA AVAILABILITY The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. References Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, et al. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020;75(6):1334–57. Gulec S. Early diagnosis saves lives: focus on patients with hypertension. Kidney Int Suppl (2011). 2013;3(4):332-4. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360(9349):1903–13. Jones DW, Appel LJ, Sheps SG, Roccella EJ, Lenfant C. Measuring Blood Pressure Accurately: New and Persistent Challenges. JAMA. 2003;289(8):1027–30. Ghuman N, Campbell P, White WB. Role of ambulatory and home blood pressure recording in clinical practice. Curr Cardiol Rep. 2009;11(6):414–21. Stergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, et al. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). Journal of Hypertension. 2019;37(3):459–66. Stergiou GS, Avolio AP, Palatini P, Kyriakoulis KG, Schutte AE, Mieke S, et al. European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens. 2023;41(12):2074–87. Atkins N, Mee F, O'Malley K, O'Brien E. The relative accuracy of simultaneous same arm, simultaneous opposite arm and sequential same arm measurements in the validation of automated blood pressure measuring devices. J Hum Hypertens. 1990;4(6):647–9. O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O'Malley K, et al. The British Hypertension Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Hypertens. 1990;8(7):607–19. Kollias A, Stathopoulou P, Kyriakoulis K, Avolio A, Mukkamala R, Stergiou G. European Society of Hypertension Protocol for Validating Novel Cuffless Blood Pressure Monitors during Handgrip Isometric Exercise. Journal of Hypertension. 2024;42(Suppl 1). Hanson P, Nagle F. Isometric exercise: cardiovascular responses in normal and cardiac populations. Cardiol Clin. 1987;5(2):157–70. Additional Declarations There is NO conflict of interest to disclose. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6456897","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":450426757,"identity":"0cb41ab7-e675-4e25-b417-04730b4389fe","order_by":0,"name":"Kazumasa Manabe","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA3ElEQVRIiWNgGAWjYBACCQh1gIEfIZZApBbJBmZStRgcIFaLZAN34ueCmjtyxjfyDz7mqalj4GfPMcCrRZqBd7P0jGPPjM1uJDMbzjh2mEGy5w1+LXIMvBukedgOJ267kcwm8YEN6MIbBGwBatn8m+ff4frNM5LZfyT8q2OwJ6QF6LBt0rxthxMMJJLZGD62MTMYSBDQItnAu82at++Z4Ywzj40lZ/Yd5pE486wArxaJA7ybb/N8uyPP35748DPPtzo5/vbkDXi1MMg/QOXz4Fc+CkbBKBgFo4AoAAA6dUQ875lquQAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0002-0691-2559","institution":"The University of Texas at Austin","correspondingAuthor":true,"prefix":"","firstName":"Kazumasa","middleName":"","lastName":"Manabe","suffix":""},{"id":450426758,"identity":"caf37958-9b11-4f96-8f5c-6229b02e2fec","order_by":1,"name":"Lin Sheng Chen","email":"","orcid":"","institution":"University of Texas at Austin","correspondingAuthor":false,"prefix":"","firstName":"Lin","middleName":"Sheng","lastName":"Chen","suffix":""},{"id":450426759,"identity":"974a1df1-7229-4b15-998f-086d5ba2f437","order_by":2,"name":"Tianyu Wang","email":"","orcid":"https://orcid.org/0000-0001-8602-8749","institution":"University of Texas at Austin","correspondingAuthor":false,"prefix":"","firstName":"Tianyu","middleName":"","lastName":"Wang","suffix":""},{"id":450426760,"identity":"2a19db95-d124-4927-bcde-483ee319a5a1","order_by":3,"name":"Gautam Vennapu","email":"","orcid":"","institution":"The University of Texas at Austin","correspondingAuthor":false,"prefix":"","firstName":"Gautam","middleName":"","lastName":"Vennapu","suffix":""},{"id":450426761,"identity":"8f0c3128-fc3b-4e1c-a00c-9f4ed5d0619a","order_by":4,"name":"Hirofumi Tanaka","email":"","orcid":"https://orcid.org/0000-0002-1780-7471","institution":"The University of Texas at Austin","correspondingAuthor":false,"prefix":"","firstName":"Hirofumi","middleName":"","lastName":"Tanaka","suffix":""}],"badges":[],"createdAt":"2025-04-15 16:55:37","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6456897/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6456897/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":82301422,"identity":"6b2fb487-757f-4110-92b5-9356f4a16828","added_by":"auto","created_at":"2025-05-08 20:58:35","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":89570,"visible":true,"origin":"","legend":"\u003cp\u003eBland-Altman plots depicting distributions of differences in systolic blood pressure (BP) and diastolic BP measured by the test device and the observers (255 sets of data). Circles show measurements made at rest and triangles show during the static hand grip exercise.\u003c/p\u003e","description":"","filename":"Slide1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6456897/v1/97047e2130680d882b28ea6e.jpg"},{"id":82300756,"identity":"8cc7a3d7-03a9-457b-9e3b-010466744761","added_by":"auto","created_at":"2025-05-08 20:50:35","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":65254,"visible":true,"origin":"","legend":"\u003cp\u003eThe correlations and regressions between the test device and observers in systolic blood pressure (BP) and diastolic BP. Circles show measurements made at rest and triangles show during the static hand grip exercise.\u003c/p\u003e","description":"","filename":"Slide2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6456897/v1/757d790ef6b6325f5c874d12.jpg"},{"id":84002617,"identity":"84e33a5a-fb97-4b83-b665-fca20335ece6","added_by":"auto","created_at":"2025-06-05 14:59:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":530198,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6456897/v1/97e0cdf9-7624-4d44-a50c-3b71c4f663ef.pdf"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e conflict of interest to disclose.","formattedTitle":"Validation of Telli BP01 Oscillometric Blood Pressure Monitor According to AAMI/ESH/ISO Standard","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eThe measurement of blood pressure (BP) is essential for evaluating cardiovascular health (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Early and accurate diagnosis of hypertension is needed to properly control hypertension and the subsequent chronic degenerative diseases, including stroke, ischemic heart disease, renal dysfunction, and dementia (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Inaccurate BP measurement to over or underestimate true BP would result in misdiagnosis of cardiovascular risks, or an increased risk of overmedication (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Thus, the development of an accurate and reliable BP measurement device would be essential to curb this obstacle. In this context, home BP monitoring is particularly ideal as it provides more accurate BP readings while avoiding white-coat hypertension and identifying masked hypertension (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eA new automated BP monitor, Telli BP01 (Telli Health, Miami, USA) has been developed for home-based use. This device is user-friendly to measure and collect BP at home in cloud storage via the mobile communication network, making it easier to manage BP changes in daily life. The accuracy of the BP monitoring device is one of the most important features. The Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH), and the International Organization for Standardization (ISO) committees have established a standardized protocol for validating noninvasive blood pressure devices, outlined in the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018\u0026thinsp;+\u0026thinsp;Amd.1:2020) (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Further, ESH recommends various situation tests for evaluating different aspects of BP changes, such as during exercise, to validate the accuracy of increasing BP (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). This study aims to validate the accuracy of the Telli BP01. The validation was conducted according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) with modifications tailored for general population use.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eParticipants\u003c/h2\u003e \u003cp\u003eAccording to the AAMI/ESH/ISO Universal Standard (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) for a general population validation study of a BP monitor, valid recordings from at least 85 participants were required. Inclusion criteria for participants were: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) age\u0026thinsp;\u0026gt;\u0026thinsp;12 years and (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) voluntarily agreed to participate in the study and provided informed consent. Exclusion criteria for participants were: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) arm circumference\u0026thinsp;\u0026lt;\u0026thinsp;22cm or \u0026gt;\u0026thinsp;42 cm, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) arrhythmias that affect BP measurements like atrial fibrillation, and (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) pregnancy.\u003c/p\u003e \u003cp\u003e The study was approved by the institutional review board at the University of Texas at Austin (STUDY00005948) and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all study participants.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eThe BP measurement devices\u003c/h3\u003e\n\u003cp\u003eThe test device, Telli BP01, is an automated oscillometric upper-arm BP monitor developed for home use. The device has a medium-size cuff (cuff size: 60 x 15 cm, bladder size: 24 x 13 cm) for an arm circumference of 22\u0026ndash;42 cm, which was used according to the manufacturer\u0026rsquo;s instructions. Two identical devices were provided by the manufacturer for the validation study, together with a written declaration that they were standard production models. One of them was randomly selected for the validation procedure.\u003c/p\u003e \u003cp\u003eThe aneroid sphygmomanometers (V223, Labtron, Atlanta, USA), which had been calibrated before the study initiation were used for simultaneous reference auscultatory BP measurements by two observers using a dual-head teaching stethoscope (Littmann Classic II SE, 3M\u0026trade;, Minnesota, USA). Both observers identified the first and fifth Korotkoff sounds as systolic and diastolic BP, respectively.\u003c/p\u003e\n\u003ch3\u003eProcedure\u003c/h3\u003e\n\u003cp\u003eThe measurements were conducted by a supervisor and two trained observers who were experienced in BP assessments. BP was simultaneously measured from the same arm, which was demonstrated as the best method for assessing device accuracy (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). A Y-connector was used to split the connection from the test cuff to both the test device and the aneroid sphygmomanometer (observer BP). Air to inflate the cuff was delivered by the test device and was simultaneously monitored by the sphygmomanometer. The initial testing phase involved a single baseline measurement, consisting of two observers\u0026rsquo; readings and a test device reading. Observers\u0026rsquo; readings are recorded concurrently with corresponding test device readings. The observers were blinded to each other\u0026rsquo;s readings and the test device results. The supervisor monitored the test device measurements and verified the accuracy of the observers' recordings to ensure agreement within \u0026le;\u0026thinsp;3 mmHg for simultaneous systolic and diastolic BP readings. At least three pairs of simultaneous measurements were taken and used for analysis. In instances where the observers' readings disagreed, additional pairs of measurements were taken. Further, systolic BP difference\u0026thinsp;\u0026ge;\u0026thinsp;12 mmHg and diastolic BP difference\u0026thinsp;\u0026ge;\u0026thinsp;8 mmHg between any two observer BP readings of the four were also retested. Two observers' readings were averaged.\u003c/p\u003e \u003cp\u003eTo examine the device's response in the situation which BP rises during daily activities such as isometric exercise (e.g., carrying a grocery bag) (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e), a subset of participants (n\u0026thinsp;=\u0026thinsp;11) were asked to perform the voluntary maximal static handgrip exercises through BP measurement to induce relatively higher BP (\u0026ge;\u0026thinsp;140 mmHg) on the contralateral hand during BP measurement.\u003c/p\u003e\n\u003ch3\u003eAnalyses\u003c/h3\u003e\n\u003cp\u003eAccording to the requirements of the AAMI/ESH/ISO universal standard (ISO 81060-2:2018\u0026thinsp;+\u0026thinsp;Amd.1:2020) (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e), the test device must meet two criteria to pass the standard. For Criterion 1, the mean of BP difference (test device minus observer BP) for all pairs of measurements must be within \u0026plusmn;\u0026thinsp;5 mmHg, and its SD must be \u0026le;\u0026thinsp;8 mmHg for both systolic and diastolic BP. For Criterion 2, the SD of all participants' mean of BP differences (the average of test device minus observer BP per participant) must be within a threshold specified in the table in the AAMI/ESH/ISO universal standard (ISO 81060-2:2018\u0026thinsp;+\u0026thinsp;Amd.1:2020) (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eValues are expressed as means\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (SD). The Bland-Altman analyses of agreement were conducted to observe the relative differences between the test devices and the observer measurements. Pearson\u0026rsquo;s correlation analyses were conducted to determine the relationships between the two different methods. \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered significant for all analyses.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eOf the 92 individuals initially recruited, seven were excluded from the study because the device could not measure their BP. All of these errors the device showed were about inflation and were in participants with arm circumferences over 37 cm. This resulted in a final sample size of 85 participants, yielding a total of 255 data points. The handgrip exercise was applied to 11 participants for 33 data points. Participant characteristics are detailed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. All participants met the predefined criteria for age, sex, arm circumference, and BP distribution (Tables\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e and \u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD of BP differences for all 255 individual data points was \u0026minus;\u0026thinsp;1.8\u0026thinsp;\u0026plusmn;\u0026thinsp;6.6/-3.7\u0026thinsp;\u0026plusmn;\u0026thinsp;5.7 mmHg (systolic/diastolic BP), which fulfilled Criterion 1. The SD of individual 85 participants averaged BP difference showed that systolic BP was 5.5 mmHg (must be \u0026le;\u0026thinsp;6.7 mmHg) and diastolic BP was 4.9 mmHg (must be \u0026le;\u0026thinsp;5.8 mmHg), which met Criterion 2. Bland\u0026ndash;Altman scatterplots of systolic BP and diastolic BP differences between the test and reference devices are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSelected participant characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eRange\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale/Female, n\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e43/42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026plusmn;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e18\u0026ndash;75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eArm circumference, cm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026plusmn;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e22\u0026ndash;39\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSystolic BP, mmHg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e123\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026plusmn;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e96\u0026ndash;164\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiastolic BP, mmHg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026plusmn;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e52\u0026ndash;123\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eBP\u0026thinsp;=\u0026thinsp;blood pressure\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDistribution of arm circumference and blood pressure (BP) of the participants\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eArm circumferences (cm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e22.0-31.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e50 (59)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e32.0\u0026ndash;42.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e35 (41)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e22.0-26.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e31 (36)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e37.0\u0026ndash;42.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e18 (21)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSystolic BP (mmHg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026le;100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e25 (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;160\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e13 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;140\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e51 (20)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiastolic BP (mmHg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026le;60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e14 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e33 (13)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e72 (28)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e shows that both systolic and diastolic BP obtained with the observer BP were strongly associated with the test device BP (both r\u0026thinsp;=\u0026thinsp;0.93, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), supporting the Bland-Altman analysis results.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study validated the accuracy of the home-based Telli BP01 BP monitoring device in the general adult population on AAMI/ESH/ISO universal standard (ISO 81060-2:2018\u0026thinsp;+\u0026thinsp;Amd.1:2020) (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Instead of the sequential method, we adopted the simultaneous method to measure BP by connecting the cuff with both the device and the reference sphygmomanometer in the current study. This method is ideal because any differences ascribable to factors other than the two measurement methods are eliminated (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Simultaneous comparison is often hindered by insufficient cuff inflation, rapid deflation, and excessive deflation rates in automated devices (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). However, this device overcame these limitations, allowing for more accurate comparisons.\u003c/p\u003e \u003cp\u003eAbout 90% of all data points during handgrip exercise were within the \u0026plusmn;\u0026thinsp;1.96 SD range in the study. ESH recommends various situation tests for evaluating different aspects of BP variability, such as during exercise to validate the accuracy of increasing BP [7]. Isometric muscle contraction with increasing BP is often seen in daily activity (e.g., holding a shopping bag, etc.) (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Thus, the device might be able to be used with the same accuracy even when or after blood pressure is elevated in daily life activity.\u003c/p\u003e \u003cp\u003eSeven participants who could not be measured were in the upper quarter of the cuff range. One possible reason that the test device could not measure may be due to the connection of the sphygmomanometer between the device and the cuff. The pump in the device has a maximum speed and the algorithm in the device expects a pressure after an amount of time. It was possible that the combination of a large arm and the blood pressure monitor required more air than the upper limit, causing the algorithm to stall.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThe Telli BP01 met the validation criteria of AAMI/ESH/ ISO universal standard (ISO 81060-2:2018\u0026thinsp;+\u0026thinsp;Amd.1:2020) and can therefore be recommended for home BP measurement in general adults.\u003c/p\u003e"},{"header":"Declarations","content":" \u003ch2\u003eDISCLOSURES\u003c/h2\u003e \u003cp\u003eThe Telli BP01 device was provided by Telli Health, Miami, USA.\u003c/p\u003e \u003ch2\u003eFUNDING\u003c/h2\u003e \u003cp\u003eThe preparation of this manuscript was partially supported by funding from Japan Society for the Promotion of Science (23KJ1618, held by K.M.).\u003c/p\u003e\u003ch2\u003eAUTHOR CONTRIBUTION\u003c/h2\u003e \u003cp\u003eThe study design, participant recruitment, and data collection were completed independently by the investigators of the University of Texas at Austin. K.M. and H.T. conceived and designed the study; all authors performed experiments; K.M. analyzed the data; K.M. prepared figures; K.M. drafted the manuscript; all authors reviewed and edited the manuscript; and all authors approved the final version of the manuscript.\u003c/p\u003e\u003ch2\u003eACKNOWLEDGEMENTS\u003c/h2\u003e \u003cp\u003eWe would like to thank Douglas Blakely and Paul Nederveen, who gave us some suggestions and helped with the content related to the Telli BP01 device.\u003c/p\u003e\n\u003ch3\u003eDATA AVAILABILITY\u003c/h3\u003e\n\u003cp\u003eThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eUnger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, et al. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020;75(6):1334\u0026ndash;57.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGulec S. Early diagnosis saves lives: focus on patients with hypertension. Kidney Int Suppl (2011). 2013;3(4):332-4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLewington S, Clarke R, Qizilbash N, Peto R, Collins R. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360(9349):1903\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJones DW, Appel LJ, Sheps SG, Roccella EJ, Lenfant C. Measuring Blood Pressure Accurately: New and Persistent Challenges. JAMA. 2003;289(8):1027\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGhuman N, Campbell P, White WB. Role of ambulatory and home blood pressure recording in clinical practice. Curr Cardiol Rep. 2009;11(6):414\u0026ndash;21.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, et al. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). Journal of Hypertension. 2019;37(3):459\u0026ndash;66.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStergiou GS, Avolio AP, Palatini P, Kyriakoulis KG, Schutte AE, Mieke S, et al. European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens. 2023;41(12):2074\u0026ndash;87.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAtkins N, Mee F, O'Malley K, O'Brien E. The relative accuracy of simultaneous same arm, simultaneous opposite arm and sequential same arm measurements in the validation of automated blood pressure measuring devices. J Hum Hypertens. 1990;4(6):647\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eO'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O'Malley K, et al. The British Hypertension Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Hypertens. 1990;8(7):607\u0026ndash;19.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKollias A, Stathopoulou P, Kyriakoulis K, Avolio A, Mukkamala R, Stergiou G. European Society of Hypertension Protocol for Validating Novel Cuffless Blood Pressure Monitors during Handgrip Isometric Exercise. Journal of Hypertension. 2024;42(Suppl 1).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHanson P, Nagle F. Isometric exercise: cardiovascular responses in normal and cardiac populations. Cardiol Clin. 1987;5(2):157\u0026ndash;70.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"accuracy, upper-arm blood pressure measurement, validation, automated, oscillometric","lastPublishedDoi":"10.21203/rs.3.rs-6456897/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6456897/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThe aim of the study was to evaluate the accuracy of a home-based oscillometric upper-arm blood pressure (BP) monitor (Telli BP01) in accordance with the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Participants were recruited to fulfill the age, sex, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard. Both the test device and the aneroid sphygmomanometer (observer BP) were connected to the BP cuff to measure BP simultaneously at rest and during maximal static hand grip (SHG). Ninety-two participants were recruited, and 85 were analyzed. Eleven participants were asked to perform SHG during the test. For validation Criterion 1, the mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD of the differences (the test device minus observer BP) for all BP readings was \u0026minus;\u0026thinsp;1.8\u0026thinsp;\u0026plusmn;\u0026thinsp;6.6/-3.7\u0026thinsp;\u0026plusmn;\u0026thinsp;5.7 mmHg (systolic/diastolic). For validation Criterion 2, the SD of all participants' averaged BP differences (the test device minus observer BP per participant) was 5.5/4.9 mmHg (systolic/diastolic). Both criteria were fulfilled in the present validation study. In conclusion, the Telli BP01 BP monitor fulfilled the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and can be recommended for use at home.\u003c/p\u003e","manuscriptTitle":"Validation of Telli BP01 Oscillometric Blood Pressure Monitor According to AAMI/ESH/ISO Standard","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-08 20:50:30","doi":"10.21203/rs.3.rs-6456897/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"6d901e28-f152-4de7-ade5-47f21f1c8ed0","owner":[],"postedDate":"May 8th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":47931721,"name":"Health sciences/Health care/Diagnosis"},{"id":47931722,"name":"Biological sciences/Physiology/Ageing"},{"id":47931723,"name":"Health sciences/Diseases/Cardiovascular diseases/Hypertension"},{"id":47931724,"name":"Health sciences/Health care/Disease prevention/Preventive medicine"},{"id":47931725,"name":"Health sciences/Risk factors"}],"tags":[],"updatedAt":"2025-06-05T14:51:32+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-08 20:50:30","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6456897","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6456897","identity":"rs-6456897","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}