Edan elite V5

Device Name:

elite

Device Model:

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 Assessment	Recommendation	Basis
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. 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))