Novacor Diasys 3 Plus
Device Name:
Diasys 3 Plus
Device Model:
DIP-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 Plus 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 Plus, 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 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.

Certification 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.

Validation Publications for Equivalent Devices:

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

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