Devices and TechnologyValidation of the YuWell YE900 oscillometric blood pressure monitor for professional office use in adults and children according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)Zhang, Hui-Jiea; Zhang, Juana; Wang, Su-Lanb; Zhang, Jinb; Teng, Li-Nib; Zhang, Shu-Juanb; Zhou, De-Junb; Long, Ming-Zhib Author Information aClinical Trial Center bDepartment of Cardiovascular Medicine, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China Received 8 November 2020 Accepted 16 March 2021 Correspondence to Ming-Zhi Long, MD, PhD, Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanjing Medical University, Jiangjiayuan Road 121, Gulou District, Nanjing 210000, China, Tel: +86 25 58509670; fax: +86 25 58509670; e-mail: [email protected] Blood Pressure Monitoring 26(5):p 396-399, October 2021. | DOI: 10.1097/MBP.0000000000000541 Buy Metrics Abstract Objective To evaluate the accuracy of the YuWell YE900 oscillometric upper-arm professional office blood pressure monitor in adults and children according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Methods Subjects were recruited to fulfill the age, sex, blood pressure and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in adults and children (aged 3–12 years) using the same arm sequential blood pressure measurement method. Three cuffs of the test device were used for arm circumference 18–22 cm (small), 22–32 cm (medium) and 32–42 cm (large). Results Ninety-two subjects were recruited, and 85 (50 adults and 35 children) were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was 1.7 ± 6.62/3.1 ± 5.76 mmHg (systolic/diastolic). For validation criterion 2, the SD of the averaged blood pressure differences between the test device and reference blood pressure per subject was 5.25/5.13 mmHg (systolic/diastolic). Conclusion The YuWell YE900 professional electronic blood pressure monitor has passed the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in adults and children and can be recommended for clinical use. Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.