Novacor Diasys 3

Device Name:Diasys 3
Device Model:DIS-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, to measure blood pressure, is certified by Medaval Ltd. It has passed in two 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
MDR CriteriaABPMPublished evidence

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

Medaval Certification Assessment

Cert ImageMedaval Ltd. Medical Device Assessment 1901AR:2019: Accreditation assessment of the blood pressure measurement technology used in the Novacor Diasys 3 (DIS-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(1901AR) 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

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 results according to accepted protocols, the clinical accuracy of the oscillometric blood pressure measurement technology, used in the Novacor Diasys 3 (DIS-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.