Devices and TechnologyValidation of the blood pressure measurement technology used in the Novacor Diasys 3 Plus (DIP-0001-00) upper-arm device for ambulatory blood pressure measurement, according to AAMI/ANSI/ISO 81060-2:2013, ESH-IP 2010 and MEDDEV 2.7/1Atkins, Neila; Fania, Claudiob; Palatini, PaolocAuthor Information aMedaval Ltd., Dublin, Ireland bReparto di Medicina, Casa di Cura Villa Maria SRL, Padova cDepartment of Medicine, University of Padova, Studium Patavinum, Italy Received 22 June 2020 Accepted 2 September 2020 Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website, www.bpmonitoring.com. Correspondence to Neil Atkins, MA, HDipEd, Medaval Ltd., Unit 107, SBC, Serpentine Ave., Ballsbridge, Dublin D04 H522, Ireland, Tel: +353 1 664 3768; e-mail: [email protected] Blood Pressure Monitoring: December 2020 - Volume 25 - Issue 6 - p 359-367 doi: 10.1097/MBP.0000000000000488 Buy SDC Metrics Abstract Objective The objective of this study was to determine the accuracy of the auscultatory and oscillometric blood pressure (BP) measurement technologies of the Novacor Diasys 3 Plus (model number DIP-0001-00) BP monitor, intended for ambulatory BP measurement when used with the recommended Standard Plus (ACC-0210-00), Large Plus (ACC-0211-00) and Paediatric Plus (ACC-0212-00) cuffs. Methods The auscultatory measurement technology Novacor Diasys 3 Plus (model number DIP-0001-00) was evaluated according to the requirements of the AAMI/ANSI/ISO 81060-2:2013 standard, including an additional cardiac-stress study, a requirement for ambulatory BP measurement devices. It was also validated according to the requirements of the European Society of Hypertension International Protocol revision 2010. The oscillometric measurement technology was compared to that of the Novacor Diasys 3 (model number DIS-0001-00) according to the equivalence requirements of MEDDEV 2.7/1 rev 4. The protocol requirements for all three studies and the equivalence were followed precisely. Results The Novacor Diasys 3 Plus (model number DIP-0001-00) fulfilled all of the requirements for a pass in each of the three studies of the auscultatory measurement technology. In the primary AAMI/ANSI/ISO 81060-2:2013 study, the criterion 1 errors were + 3.6 ± 2.7 mmHg for SBP and + 3.0 ± 2.7 mmHg for DBP. It was also proven to be equivalent to the Novacor Diasys 3 (model number DIS-0001-00) with respect to the oscillometric measurement technology Conclusion The Novacor Diasys 3 Plus (model number DIP-0001-00), when used with the recommended cuffs, can be recommended for ambulatory BP measurement in the adult population. Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.