Novacor Diasys 3 Plus

Device Name:Diasys 3 Plus
Device Model:DIP-0001-00
Manufacturer:Sole: Novacor SAS, 4 passage Saint-Antoine, 92508 Rueil-Malmaison, Cedex, FRANCE.
Measuring functions:Blood pressure
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

The accuracy of the technology used in the Novacor Diasys 3 Plus, to measure blood pressure, is certified by Medaval Ltd. It has passed in four validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★★★ Certified AccuracyRecent clinical validation; recent protocol with certified adherence; multiple clinical validations

Device Family:Novacor Diasys 3M (M MEDDEV 2.7/1 rev 4 Equivalence)
Validation Publications

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.

Cert ImageMedaval 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.

Relevant Publications

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.