| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | ★★★★★ Certified Accuracy | Recent clinical validation; recent protocol with certified adherence; multiple clinical validations |
| BP | BIHS (UK and IRL) | ABPM | Published evidence |
| BP | Stride BP | ABPM for adults (Preferred) | Published evidence |
| BP | MDR Criteria | ABPM | Published evidence |
Atkins N, Fania C, Palatini P. Validation 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 2.7/1 Blood Press Monit. 2020 Dec;25(6):359-367. Epub: 2020 Oct 16. doi: 10.1097/MBP.0000000000000488. PMID: 33074927.
81060-2:2013 - Pass General population (Note: Primary 85-subject study)
81060-2:2013 - Pass General population (Note: Stress study, as required for ABPM devices (n=36))
ESH-IP:2010 - Pass General population
Direct validation of auscultatory measurements and validation by MEDDEV 2.7/1 rev 4 equivalence, to Novacor Diasys 3, of oscillometric measurements.
Medaval Certification Assessment
Medaval Ltd. Medical Device Assessment 1902AR:2019: Accreditation assessment of the auscultatory blood pressure measurement technology used in the Novacor Diasys 3 Plus (DIP-0001-00) upper arm ABPM monitor, as validated according to the AAMI/ANSI/ISO 81060-2:2013 standard both for a general study in adults and for an additional ABPM-device study and according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2019 Mar 05;2019(1902AR) 23 p. Available from: www.medaval.ie.
81060-2:2013 - Pass General population (Note: Primary 85-subject study)
81060-2:2013 - Pass General population (Note: Stress study, as required for ABPM devices (n=36))
ESH-IP:2010 - Pass General population
Auscultatory measurements only. Subjects in the 81060-2:2013 stress study are independent of those in the ESH-IP study. With proven validity of validation results according to accepted protocols, the clinical accuracy of the auscultatory blood pressure measurement technology, used in the Novacor Diasys 3 Plus (DIP-0001-00), is certified by Medaval Ltd.
Medaval Ltd. Medical Device Assessment 1904SR:2019: Accreditation assessment of the oscillometric blood pressure measurement technology used in the Novacor Diasys 3 Plus (DIP-0001-00) upper arm ABPM monitor, as validated, by comparative- equivalence, according to the AAMI/ANSI/ISO 81060-2:2013 standard both for a general study in adults and for an additional ABPM-device study and according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2019 Mar 05;2019(1904SR) 4 p. Available from: www.medaval.ie.
81060-2:2013 - Pass General population (Note: Primary 85-subject study)
81060-2:2013 - Pass General population (Note: Stress study, as required for ABPM devices (n=36))
ESH-IP:2010 - Pass General population
The results of the specified validations are applied to the Novacor Diasys 3 Plus, as a consequence of proven comparative-equivalence.
Oscillometric measurements only. Subjects in the 81060-2:2013 stress study are independent of those in the ESH-IP study. With proven validity of validation and equivalence results according to accepted protocols, the clinical accuracy of the oscillometric blood pressure measurement technology, used in the Novacor Diasys 3 Plus (DIP-0001-00), is certified by Medaval Ltd.
Medaval Ltd. Medical Device Assessment 1903AR:2019: Comparative-Equivalence assessment of the oscillometric blood pressure measurement technology used in the Novacor Diasys 3 Plus (DIS-0001-00) and the Novacor Diasys 3 (DIS-0001-00) upper arm ABPM monitors, according to the requirements of MEDDEV 2.7/1 rev 4. Medical Device Assessment. 2019 Mar 05;2019(1903AR) 8 p. Available from: www.medaval.ie.
The oscillometric blood pressure measurement technologies in the Novacor Diasys 3 Plus and in the Novacor Diasys 3 are proven to be equivalent, according to MEDDEV 2.7/1 rev 4. The Novacor Diasys 3 Plus is shown to be "superior" to the Novacor Diasys 3, as it contains more features.
Novacor Diasys 3
Atkins N, Fania C, Palatini P. Validation of the blood pressure measurement technology used in the Novacor Diasys 3 (DIS-0001-00) upper arm device for ambulatory blood pressure measurement, according to the requirements of the AAMI/ANSI/ISO 81060-2: 2013 standard (for both a general study and a cardiac-stress study in adults) and of the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2021 Feb;26(1):70-77. Epub: 2020 Nov 23. doi: 10.1097/MBP.0000000000000493. PMID: 33234813.
81060-2:2013 - Pass General population (Note: Primary 85-subject study)
81060-2:2013 - Pass General population (Note: Stress study, as required for ABPM devices (n=36))
ESH-IP:2010 - Pass General population