Validation of the Hanvon KSY8600 Blood Pressure Monitor in the General Population Based on AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020 Protocol

Validation of the Hanvon KSY8600 Blood Pressure Monitor in the General Population Based on AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020 Protocol | 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 the Hanvon KSY8600 Blood Pressure Monitor in the General Population Based on AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020 Protocol Jian Wang, Yingjian Liu, Chongjie Chen This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7071009/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 19 Jan, 2026 Read the published version in Journal of Human Hypertension → Version 1 posted 10 You are reading this latest preprint version Abstract This study evaluated the accuracy of the Hanvon KSY8600 blood pressure monitor in adult populations in accordance with the AAMI/ESH/ISO (ISO 81060-2:2018) and AMD 1:2020 standards. 90 people were recruited as research participants, among which 88 eligible participants were chosen and analyzed according to the research plan. The average age of these participants was 51.3 ± 17.35 years old, with an average arm circumference of 28.1 ± 3.41 cm, and with females accounting for 60.2%. The test results showed that the mean differences (standard deviations) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) displayed on the blood pressure monitor were − 0.4 mmHg (2.09 mmHg) and − 0.3 mmHg (1.86 mmHg) respectively, meeting the requirements of Criterion 1 ( ≤ ± 5mmHg (8mmHg)). Additionally, the average standard deviations of the participants' SBP and DBP were 0.91 mmHg and 0.90 mmHg respectively. According to Table 1 of Criterion 2, the mean values of SBP and DBP were − 0.4mmHg and − 0.3mmHg respectively, with maximum allowable standard deviations of SBP and DBP of ≤ 6.93 and ≤ 6.95 mmHg respectively, meeting the requirements of Criterion 2. It was thus proved that the blood pressure monitor complies with AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020, and is recommended for clinical and home blood pressure measurement for adults. Health sciences/Health care/Disease prevention/Lifestyle modification Health sciences/Risk factors Health sciences/Health care/Diagnosis Figures Figure 1 Figure 2 Introduction Most modern clinical and home blood pressure monitoring devices employ the oscillometric method to measure blood pressure [ 1 ]. However, this indirect measurement method is based on arterial pressure fluctuations and may be subject to significant deviations from the actual values in specific populations, such as those with arrhythmia or arteriosclerosis [ 2 , 3 ]. As the gold clinical standard for non-invasive blood pressure measurement, the Korotkoff Sound method [ 4 ] ensures precise measurements by detecting characteristic changes in acoustic signals of arterial wall vibrations. The Hanvon KSY8600 blood pressure monitor used in this study combines the traditional Korotkoff Sound method with innovative electronics, thus eliminating previous systematic errors caused by subjective judgments of observers in more traditional manual measurements. This is achieved using high-sensitivity acoustic sensors and intelligent algorithms while still adhering to the core principles of manual auscultation. The study evaluated the measurement accuracy of the Hanvon KSY8600 blood pressure monitor in adult populations through clinical trials in accordance with the AAMI/ESH/ISO (ISO 81060-2:2018) and AMD1:2020 standards, which have been recommended in the clinical guidelines of numerous countries for the diagnosis of hypertension [ 5 ]. This provides evidence-based medical support for the clinical applicability of the device, and its suitability for home-based healthcare. Methods Participants This clinical trial began on November 7, 2024, and was approved by the Ethics Committee of the Beijing Geriatric Hospital. All participants signed a written Letter of Informed Consent. According to the general population validation requirements of AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020, there should be at least 85 participants aged over 12 years. The criteria for participant selection are as follows: (1) Participants should sign the Letter of Informed Consent voluntarily; (2) They should be willing and able to complete all study procedures as per the trial plan; (3) They have not participated in other clinical trials within the past week. The following individuals should be excluded from the trial: (1) Individuals whose blood pressure measurement cannot be performed normally; (2) Individuals with severe circulatory disorders or in severe shock; using cardiopulmonary machines; with upper limb infections or catheters inserted in the arms; as well as newborns or children; (3) Individuals with arrhythmia; (4) Individuals who did not sign the Letter of informed Consent or were otherwise deemed ineligible for the trial by the researchers. Instruments The test device, the Hanvon KSY8600 BP monitor, utilizes the Korotkoff sound method to measure SBP, DBP, and pulse rate. This device measures blood pressure in the range of 0–299 mmHg and pulse rate in the range of 40–240 beats per minute(bpm). It is designed for blood pressure measurement in participants with an arm circumference ranging from 22.0 to 34.0 cm. Additionally, the device features NB or Bluetooth connectivity for automatic transmission of measurement data to an electronic application after measurement. It also fulfills such functions as intelligent pressurization, irregular pulse detection, motion detection, and Korotkoff sound playback. Observer training and assessment In order to evaluate the blood pressure measurement device, a number of trained observers were recruited as observers and trained according to the protocols of the British & Irish Hypertension Society. They received training on correct auscultation techniques, observation posture, cuff placement, and appropriate participant positioning. Observers were blinded to each other's readings and the device results during measurements. For blood pressure measurement using the Korotkoff sound method, two observers simultaneously observed the pressure values on a mercury sphygmomanometer (calibrated before the study) while performing auscultation using a double stethoscope (Y-tube). After identifying the Korotkoff sound for high and low blood pressure, they recorded their readings independently with no knowledge of each other’s results, while a third observer, acting as supervisor, checked the readings of the other two observers. Procedures Half an hour before having their blood pressure taken, the participants refrained from smoking, coffee drinking, and strenuous exercise; they emptied their bladders as much as possible, rested in a quiet environment for 10–15 minutes to keep calm, placed their feet flat on the ground, and kept their arms at the same horizontal level as their heart. During blood pressure measurement, the participants remained quiet, placed their arms flat on the table with palms facing up, and refrained from clenching their fists. The measurement adopted the “Same-Arm Sequential Method” as required by AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020, with the average of the two observers' readings used as the reference blood pressure for each measurement. Table 1 Characteristics of study participants (KSY8600 n = 88). Variable ISO 81060-2:2018 + AMD1:2020 (%) KSY8600 Age, y (range) 51.3 ± 17.35 years (21–83 years) Men: women, n (%) Men(≥ 30%);women(≥ 30%) 35(39.8%): 53 (60.2%) Arm circumference, cm (range) 28.1 ± 3.41cm (22.0–34.0 cm) ≥ 22.0and < 25.0cm ≥ 20% 26(29.5%) ≥ 25.0and ≤ 28.0cm ≥ 20% 20(22.7%) ≥ 28.0and ≤ 31.0cm ≥ 20% 22(25.0%) ≥ 31.0and ≤ 34cm ≥ 20% 20(22.7%) ≥ 22.0and ≤ 23.5cm ≥ 10% 9 (10.2%) ≥ 32.5and ≤ 34cm ≥ 10% 18 (20.5%) SBP, mmHg(range) ≤ 100 mmHg ≥ 5% 29(11.0%) ≥ 160 mmHg ≥ 5% 15(5.7%) ≥140 mmHg ≥ 20% 57(21.6%) DBP, mmHg(range) ≤ 60 mmHg ≥ 5% 23(8.7%) ≥ 100 mmHg ≥ 5% 19(7.2%) ≥85 mmHg ≥ 20% 69(26.1%) Percentages for SBP/DBP ranges are based on 264 measurements from 88 subjects. Results A total of 90 participants were recruited for the clinical study, with 2 participants subsequently excluded due to excessive blood pressure fluctuations (SBP deviations > 12 mmHg or DBP deviations > 8 mmHg across the entire measurement dataset) according to AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020. A total of 264 valid measurement pairs from 88 participants were analyzed. The participants consisted of 35 males (39.8%) and 53 females (60.2%) aged 21 to 83, with arm circumferences ranging from 22 to 34 cm, SBP ranging from 88.0 to 180.0 mmHg, and DBP ranging from 50.0 to 112.0 mmHg. Their age, gender, arm circumference, and blood pressure all met the standard requirements (as detailed in Table 1 ). According to Criterion1, 264 valid paired measurements showed mean differences of -0.42 mmHg and − 0.25 mmHg for SBP and DBP respectively, with standard deviations of 2.09 mmHg and 1.86 mmHg. The mean differences between SBP and DBP were less than 5 mmHg, while the standard deviations were less than 8 mmHg, meeting the requirements of Criterion 1. According to Criterion 2, the average values of 88 valid paired individuals showed that the SBP standard deviation (SD) between the test and reference devices was 0.91 mmHg (SD < 6.93 mmHg), while the DBP SD was 0.90 mmHg (SD < 6.95 mmHg), meeting Criterion 2. The distribution of measurement differences (for a total of 264 sets of data) by KSY8600 and the reference device for SBP (mmHg) and DBP (mmHg) are shown in Fig. 2 (a) and 2 (b) respectively, while the distribution of measurement differences and arm circumference by KSY8600 and the reference device for SBP(mmHg) and DBP(mmHg) are shown in Fig. 2 (c) and 2 (d) respectively. Discussion This study validates the measurement accuracy of the Hanvon KSY8600 blood pressure monitor in adult populations according to AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020. The results show that measurements obtained using the Hanvon test device and the reference device are very close and meet all the requirements of the standards. Conclusion The Hanvon KSY8600 blood pressure monitor complies with the validation standards of AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020. Therefore, it is recommended for clinical or home blood pressure measurement in adults with an arm circumference ranging from 22 to 34 cm. Declarations Acknowledge This study was funded by Beijing Hanvon Health Technology Co., Ltd. Conflicts of interest There are no conflicts of interest. References STRIDE BP. Validated blood pressure monitors. 2024. https://www.stridebp.org/bp-monitors/ . Sharman JE, Tan I, Stergiou GS, Lombardi C, Saladini F, Butlin M, et al. Automated ‘oscillometric’ blood pressure measuring devices: how they work and what they measure. J Hum Hypertens. 2023;37:93–100. Stergiou GS, Lourida P, Tzamouranis D, Baibas NM. Unreliable oscillometric blood pressure measurement: prevalence, repeatability and characteristics of the phenomenon. J Hum Hypertens. 2009;23:794–800. Babbs CF. The origin of Korotkoff sounds and the accuracy of auscultatory blood pressure measurements. J Am Soc Hypertens. 2015;9:935–50. ISO 81060-2:2018/AMD 2:2024 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 2. International Organization for Standardization. 2024. https://www.iso.org/standard/83598.html . Additional Declarations There is NO conflict of interest to disclose. Cite Share Download PDF Status: Published Journal Publication published 19 Jan, 2026 Read the published version in Journal of Human Hypertension → Version 1 posted Editorial decision: revise 13 Aug, 2025 Review # 1 received at journal 03 Aug, 2025 Review # 2 received at journal 22 Jul, 2025 Reviewer # 2 agreed at journal 22 Jul, 2025 Reviewer # 1 agreed at journal 22 Jul, 2025 Reviewers invited by journal 22 Jul, 2025 Editor assigned by journal 21 Jul, 2025 Submission checks completed at journal 10 Jul, 2025 First submitted to journal 08 Jul, 2025 Unknown event 08 Jul, 2025 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-7071009","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":488944295,"identity":"7437fcb8-c9f1-415c-a497-15c6a8c1d711","order_by":0,"name":"Jian Wang","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAklEQVRIie3PMUvDQBTA8YSDy/LSwy3H+SEOCilCSb7KhUBd4ioODk8C6eacfJHieOXALkFXoQ5CoXOydFLRwYAOXhwL3m+64f0f9zzPcY5QUH49GCGbLnudA2NoT/wh4ctq4fW4OOW1HkmGlbJtY79BM5eoRpIl2e/g+jnBJxXvwrtHkJ72u76wfYzOpnC/z29qdT4N2y3MCBLerKy3xKKgJieR0gLoFs5QUxJak+AgineT0yjDz+QBpFb25KSEWFxUJgEwlDeVHk8EgUvxdmtUFFREdm0OvF6X1lsmbLPi9cGkqWH9i7pKUsbKdddbkkGG3+7D36Z+SP805TiO8z99ANv7U3Rpkhz/AAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0001-5249-2252","institution":"Beijing Geriatric Hospital","correspondingAuthor":true,"prefix":"","firstName":"Jian","middleName":"","lastName":"Wang","suffix":""},{"id":488944296,"identity":"03bd184c-c29f-4129-8604-ae3024b976cc","order_by":1,"name":"Yingjian Liu","email":"","orcid":"","institution":"Chinese Academy of Sciences","correspondingAuthor":false,"prefix":"","firstName":"Yingjian","middleName":"","lastName":"Liu","suffix":""},{"id":488944297,"identity":"cdbc3a44-4acc-44c9-8be2-d9eaf15d2c6e","order_by":2,"name":"Chongjie Chen","email":"","orcid":"","institution":"Beijing Geriatric Hospital","correspondingAuthor":false,"prefix":"","firstName":"Chongjie","middleName":"","lastName":"Chen","suffix":""}],"badges":[],"createdAt":"2025-07-08 06:05:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7071009/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7071009/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41371-026-01111-2","type":"published","date":"2026-01-19T05:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":87701503,"identity":"1e098fb9-7599-42fc-bd55-4109f9c0c247","added_by":"auto","created_at":"2025-07-28 07:24:02","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":151016,"visible":true,"origin":"","legend":"\u003cp\u003eAppearance of the Hanvon KSY8600 blood pressure (BP) monitor.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7071009/v1/da005b1351c5493cb82e52fd.png"},{"id":87701520,"identity":"461cc1e5-9435-4d88-baaf-2063c8598b40","added_by":"auto","created_at":"2025-07-28 07:24:08","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":634569,"visible":true,"origin":"","legend":"\u003cp\u003eDistribution of Blood Pressure Differences and Arm Circumference Correlation for the KSY8600 Device.\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7071009/v1/8b623fc75467d7d9d70b9f27.jpeg"},{"id":100667484,"identity":"29219f2b-384c-4b3a-ab0a-a3713d0bb10b","added_by":"auto","created_at":"2026-01-20 09:47:17","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1134340,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7071009/v1/6a063f10-d391-45cb-8227-ea6732b9cf61.pdf"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e conflict of interest to disclose.","formattedTitle":"Validation of the Hanvon KSY8600 Blood Pressure Monitor in the General Population Based on AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020 Protocol","fulltext":[{"header":"Introduction","content":"\u003cp\u003eMost modern clinical and home blood pressure monitoring devices employ the oscillometric method to measure blood pressure [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. However, this indirect measurement method is based on arterial pressure fluctuations and may be subject to significant deviations from the actual values in specific populations, such as those with arrhythmia or arteriosclerosis [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. As the gold clinical standard for non-invasive blood pressure measurement, the Korotkoff Sound method [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] ensures precise measurements by detecting characteristic changes in acoustic signals of arterial wall vibrations. The Hanvon KSY8600 blood pressure monitor used in this study combines the traditional Korotkoff Sound method with innovative electronics, thus eliminating previous systematic errors caused by subjective judgments of observers in more traditional manual measurements. This is achieved using high-sensitivity acoustic sensors and intelligent algorithms while still adhering to the core principles of manual auscultation. The study evaluated the measurement accuracy of the Hanvon KSY8600 blood pressure monitor in adult populations through clinical trials in accordance with the AAMI/ESH/ISO (ISO 81060-2:2018) and AMD1:2020 standards, which have been recommended in the clinical guidelines of numerous countries for the diagnosis of hypertension [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. This provides evidence-based medical support for the clinical applicability of the device, and its suitability for home-based healthcare.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cb\u003eParticipants\u003c/b\u003e\u003c/p\u003e\u003cp\u003e This clinical trial began on November 7, 2024, and was approved by the Ethics Committee of the Beijing Geriatric Hospital. All participants signed a written Letter of Informed Consent. According to the general population validation requirements of AAMI/ESH/ISO (ISO 81060-2:2018)\u0026thinsp;+\u0026thinsp;AMD1:2020, there should be at least 85 participants aged over 12 years. The criteria for participant selection are as follows: (1) Participants should sign the Letter of Informed Consent voluntarily; (2) They should be willing and able to complete all study procedures as per the trial plan; (3) They have not participated in other clinical trials within the past week.\u003c/p\u003e\u003cp\u003eThe following individuals should be excluded from the trial: (1) Individuals whose blood pressure measurement cannot be performed normally; (2) Individuals with severe circulatory disorders or in severe shock; using cardiopulmonary machines; with upper limb infections or catheters inserted in the arms; as well as newborns or children; (3) Individuals with arrhythmia; (4) Individuals who did not sign the Letter of informed Consent or were otherwise deemed ineligible for the trial by the researchers.\u003c/p\u003e\u003cp\u003e\u003cb\u003eInstruments\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe test device, the Hanvon KSY8600 BP monitor, utilizes the Korotkoff sound method to measure SBP, DBP, and pulse rate. This device measures blood pressure in the range of 0\u0026ndash;299 mmHg and pulse rate in the range of 40\u0026ndash;240 beats per minute(bpm). It is designed for blood pressure measurement in participants with an arm circumference ranging from 22.0 to 34.0 cm. Additionally, the device features NB or Bluetooth connectivity for automatic transmission of measurement data to an electronic application after measurement. It also fulfills such functions as intelligent pressurization, irregular pulse detection, motion detection, and Korotkoff sound playback.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eObserver training and assessment\u003c/b\u003e\u003c/p\u003e\u003cp\u003eIn order to evaluate the blood pressure measurement device, a number of trained observers were recruited as observers and trained according to the protocols of the British \u0026amp; Irish Hypertension Society. They received training on correct auscultation techniques, observation posture, cuff placement, and appropriate participant positioning. Observers were blinded to each other's readings and the device results during measurements.\u003c/p\u003e\u003cp\u003eFor blood pressure measurement using the Korotkoff sound method, two observers simultaneously observed the pressure values on a mercury sphygmomanometer (calibrated before the study) while performing auscultation using a double stethoscope (Y-tube). After identifying the Korotkoff sound for high and low blood pressure, they recorded their readings independently with no knowledge of each other\u0026rsquo;s results, while a third observer, acting as supervisor, checked the readings of the other two observers.\u003c/p\u003e\u003cp\u003e\u003cb\u003eProcedures\u003c/b\u003e\u003c/p\u003e\u003cp\u003e Half an hour before having their blood pressure taken, the participants refrained from smoking, coffee drinking, and strenuous exercise; they emptied their bladders as much as possible, rested in a quiet environment for 10\u0026ndash;15 minutes to keep calm, placed their feet flat on the ground, and kept their arms at the same horizontal level as their heart. During blood pressure measurement, the participants remained quiet, placed their arms flat on the table with palms facing up, and refrained from clenching their fists. The measurement adopted the \u0026ldquo;Same-Arm Sequential Method\u0026rdquo; as required by AAMI/ESH/ISO (ISO 81060-2:2018)\u0026thinsp;+\u0026thinsp;AMD1:2020, with the average of the two observers' readings used as the reference blood pressure for each measurement.\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\u003eCharacteristics of study participants (KSY8600 n\u0026thinsp;=\u0026thinsp;88).\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\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\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eISO 81060-2:2018\u0026thinsp;+\u0026thinsp;AMD1:2020\u003c/p\u003e\u003cp\u003e(%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eKSY8600\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge, y (range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e51.3\u0026thinsp;\u0026plusmn;\u0026thinsp;17.35 years\u003c/p\u003e\u003cp\u003e(21\u0026ndash;83 years)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMen: women, n (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMen(\u0026ge;\u0026thinsp;30%);women(\u0026ge;\u0026thinsp;30%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e35(39.8%): 53\u003c/p\u003e\u003cp\u003e(60.2%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eArm circumference,\u003c/p\u003e\u003cp\u003ecm (range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e28.1\u0026thinsp;\u0026plusmn;\u0026thinsp;3.41cm\u003c/p\u003e\u003cp\u003e(22.0\u0026ndash;34.0 cm)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;22.0and\u0026thinsp;\u0026lt;\u0026thinsp;25.0cm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;20%\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e26(29.5%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;25.0and\u0026thinsp;\u0026le;\u0026thinsp;28.0cm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;20%\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e20(22.7%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;28.0and\u0026thinsp;\u0026le;\u0026thinsp;31.0cm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;20%\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e22(25.0%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;31.0and\u0026thinsp;\u0026le;\u0026thinsp;34cm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;20%\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e20(22.7%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;22.0and\u0026thinsp;\u0026le;\u0026thinsp;23.5cm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;10%\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9 (10.2%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;32.5and\u0026thinsp;\u0026le;\u0026thinsp;34cm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;10%\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e18 (20.5%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSBP, mmHg(range)\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\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026le;\u0026thinsp;100 mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;5%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e29(11.0%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;160 mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;5%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e15(5.7%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;140 mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;20%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e57(21.6%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDBP, mmHg(range)\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\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026le;\u0026thinsp;60 mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;5%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e23(8.7%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;100 mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;5%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e19(7.2%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;85 mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;20%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e69(26.1%)\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\u003ePercentages for SBP/DBP ranges are based on 264 measurements from 88 subjects.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 90 participants were recruited for the clinical study, with 2 participants subsequently excluded due to excessive blood pressure fluctuations (SBP deviations\u0026thinsp;\u0026gt;\u0026thinsp;12 mmHg or DBP deviations\u0026thinsp;\u0026gt;\u0026thinsp;8 mmHg across the entire measurement dataset) according to AAMI/ESH/ISO (ISO 81060-2:2018)\u0026thinsp;+\u0026thinsp;AMD1:2020. A total of 264 valid measurement pairs from 88 participants were analyzed. The participants consisted of 35 males (39.8%) and 53 females (60.2%) aged 21 to 83, with arm circumferences ranging from 22 to 34 cm, SBP ranging from 88.0 to 180.0 mmHg, and DBP ranging from 50.0 to 112.0 mmHg. Their age, gender, arm circumference, and blood pressure all met the standard requirements (as detailed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). According to Criterion1, 264 valid paired measurements showed mean differences of -0.42 mmHg and \u0026minus;\u0026thinsp;0.25 mmHg for SBP and DBP respectively, with standard deviations of 2.09 mmHg and 1.86 mmHg. The mean differences between SBP and DBP were less than 5 mmHg, while the standard deviations were less than 8 mmHg, meeting the requirements of Criterion 1. According to Criterion 2, the average values of 88 valid paired individuals showed that the SBP standard deviation (SD) between the test and reference devices was 0.91 mmHg (SD\u0026thinsp;\u0026lt;\u0026thinsp;6.93 mmHg), while the DBP SD was 0.90 mmHg (SD\u0026thinsp;\u0026lt;\u0026thinsp;6.95 mmHg), meeting Criterion 2.\u003c/p\u003e\u003cp\u003eThe distribution of measurement differences (for a total of 264 sets of data) by KSY8600 and the reference device for SBP (mmHg) and DBP (mmHg) are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e (a) and 2 (b) respectively, while the distribution of measurement differences and arm circumference by KSY8600 and the reference device for SBP(mmHg) and DBP(mmHg) are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e (c) and 2 (d) respectively.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study validates the measurement accuracy of the Hanvon KSY8600 blood pressure monitor in adult populations according to AAMI/ESH/ISO (ISO 81060-2:2018)\u0026thinsp;+\u0026thinsp;AMD1:2020. The results show that measurements obtained using the Hanvon test device and the reference device are very close and meet all the requirements of the standards.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe Hanvon KSY8600 blood pressure monitor complies with the validation standards of AAMI/ESH/ISO (ISO 81060-2:2018)\u0026thinsp;+\u0026thinsp;AMD1:2020. Therefore, it is recommended for clinical or home blood pressure measurement in adults with an arm circumference ranging from 22 to 34 cm.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cb\u003eAcknowledge\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study was funded by Beijing Hanvon Health Technology Co., Ltd.\u003c/p\u003e\u003cp\u003e\u003ch2\u003eConflicts of interest\u003c/h2\u003e\u003cp\u003eThere are no conflicts of interest.\u003c/p\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eSTRIDE BP. Validated blood pressure monitors. 2024. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.stridebp.org/bp-monitors/\u003c/span\u003e\u003cspan address=\"https://www.stridebp.org/bp-monitors/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSharman JE, Tan I, Stergiou GS, Lombardi C, Saladini F, Butlin M, et al. Automated \u0026lsquo;oscillometric\u0026rsquo; blood pressure measuring devices: how they work and what they measure. J Hum Hypertens. 2023;37:93\u0026ndash;100.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eStergiou GS, Lourida P, Tzamouranis D, Baibas NM. Unreliable oscillometric blood pressure measurement: prevalence, repeatability and characteristics of the phenomenon. J Hum Hypertens. 2009;23:794\u0026ndash;800.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBabbs CF. The origin of Korotkoff sounds and the accuracy of auscultatory blood pressure measurements. J Am Soc Hypertens. 2015;9:935\u0026ndash;50.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eISO 81060-2:2018/AMD 2:2024 Non-invasive sphygmomanometers \u0026mdash; Part 2: Clinical investigation of intermittent automated measurement type \u0026mdash; Amendment 2. International Organization for Standardization. 2024. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.iso.org/standard/83598.html\u003c/span\u003e\u003cspan address=\"https://www.iso.org/standard/83598.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-human-hypertension","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"jhh","sideBox":"Learn more about [Journal of Human Hypertension](http://www.nature.com/jhh/)","snPcode":"41371","submissionUrl":"https://mts-jhh.nature.com/cgi-bin/main.plex","title":"Journal of Human Hypertension","twitterHandle":"@jhhypertension","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-7071009/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7071009/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThis study evaluated the accuracy of the Hanvon KSY8600 blood pressure monitor in adult populations in accordance with the AAMI/ESH/ISO (ISO 81060-2:2018) and AMD 1:2020 standards. 90 people were recruited as research participants, among which 88 eligible participants were chosen and analyzed according to the research plan. The average age of these participants was 51.3\u0026thinsp;\u0026plusmn;\u0026thinsp;17.35 years old, with an average arm circumference of 28.1\u0026thinsp;\u0026plusmn;\u0026thinsp;3.41 cm, and with females accounting for 60.2%. The test results showed that the mean differences (standard deviations) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) displayed on the blood pressure monitor were \u0026minus;\u0026thinsp;0.4 mmHg (2.09 mmHg) and \u0026minus;\u0026thinsp;0.3 mmHg (1.86 mmHg) respectively, meeting the requirements of Criterion 1 (\u0026thinsp;\u0026le;\u0026thinsp;\u0026plusmn;\u0026thinsp;5mmHg (8mmHg)). Additionally, the average standard deviations of the participants' SBP and DBP were 0.91 mmHg and 0.90 mmHg respectively. According to Table\u0026nbsp;1 of Criterion 2, the mean values of SBP and DBP were \u0026minus;\u0026thinsp;0.4mmHg and \u0026minus;\u0026thinsp;0.3mmHg respectively, with maximum allowable standard deviations of SBP and DBP of \u0026le;\u0026thinsp;6.93 and \u0026le;\u0026thinsp;6.95 mmHg respectively, meeting the requirements of Criterion 2. It was thus proved that the blood pressure monitor complies with AAMI/ESH/ISO (ISO 81060-2:2018)\u0026thinsp;+\u0026thinsp;AMD1:2020, and is recommended for clinical and home blood pressure measurement for adults.\u003c/p\u003e","manuscriptTitle":"Validation of the Hanvon KSY8600 Blood Pressure Monitor in the General Population Based on AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020 Protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-28 07:23:26","doi":"10.21203/rs.3.rs-7071009/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"revise","date":"2025-08-13T17:43:39+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"This content is not available.","date":"2025-08-04T02:49:53+00:00","index":1,"fulltext":"This content is not available."},{"type":"editorInvitedReview","content":"This content is not available.","date":"2025-07-22T14:09:44+00:00","index":2,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2025-07-22T13:20:59+00:00","index":2,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2025-07-22T11:48:32+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewersInvited","content":"","date":"2025-07-22T05:57:53+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-22T03:53:25+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-07-10T16:56:25+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Human Hypertension","date":"2025-07-09T03:44:31+00:00","index":"","fulltext":""},{"type":"checksFailed","content":"","date":"2025-07-08T18:13:41+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-human-hypertension","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"jhh","sideBox":"Learn more about [Journal of Human Hypertension](http://www.nature.com/jhh/)","snPcode":"41371","submissionUrl":"https://mts-jhh.nature.com/cgi-bin/main.plex","title":"Journal of Human Hypertension","twitterHandle":"@jhhypertension","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"6c1b0bd7-03a7-43ad-a6e6-66c348e1925b","owner":[],"postedDate":"July 28th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":51904742,"name":"Health sciences/Health care/Disease prevention/Lifestyle modification"},{"id":51904743,"name":"Health sciences/Risk factors"},{"id":51904744,"name":"Health sciences/Health care/Diagnosis"}],"tags":[],"updatedAt":"2026-01-20T09:12:32+00:00","versionOfRecord":{"articleIdentity":"rs-7071009","link":"https://doi.org/10.1038/s41371-026-01111-2","journal":{"identity":"journal-of-human-hypertension","isVorOnly":false,"title":"Journal of Human Hypertension"},"publishedOn":"2026-01-19 05:00:00","publishedOnDateReadable":"January 19th, 2026"},"versionCreatedAt":"2025-07-28 07:23:26","video":"","vorDoi":"10.1038/s41371-026-01111-2","vorDoiUrl":"https://doi.org/10.1038/s41371-026-01111-2","workflowStages":[]},"version":"v1","identity":"rs-7071009","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7071009","identity":"rs-7071009","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}