Edan elite V5
Device Name:
elite
Device Model:
V5
Manufacturer:
Edan Instruments Inc., No. 15 Jinhui Rd., Jinsha Community, Kengzi Subdistrict, Pingshan District, 518122 Shenzhen, CHINA.
Measuring functions:
Blood pressure, Vital Signs
Primary Client Use:
Intended for patient monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Single and intermittent measurements
Availability:
Available Currently
Description:
The Edan elite V5 is a patient monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for bedside patient monitoring.
Assessment:
The technology used in the Edan elite V5, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; recent protocol
Validation Publications:

Wan Y, Li D, Chen JF, Zhang Y. Validation of noninvasive blood pressure monitoring function of EDAN elite V5 patient monitor with reference invasive measurement according to the ISO 81060-2:2018 standard. Blood Press Monit. 2024 Jun 1;29(3):156-160. Epub: 2024 Feb 19. doi: 10.1097/MBP.0000000000000694. PMID: 38411950.

81060-2:2019 - Pass General population (Note: iFAST algorithm, intra-arterial measurements (n=35))

81060-2:2019 - Pass General population (Note: iCUFS algorithm, intra-arterial measurements (n=36))