Novacor Diasys 3
Device Name:
Diasys 3
Device Model:
DIS-0001-00
Manufacturer:
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
Description:
The Novacor Diasys 3 is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 5-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
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 six clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
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
Device Family:
Novacor Diasys 3M, Novacor Diasys 3 PlusM
Legend: M MEDDEV 2.7/1 rev 4 Equivalence
Validation Publications:

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

Medaval Certification Assessment

Certification 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.

Validation Publications for Equivalent Devices:

Novacor Diasys 3 Plus

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.

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