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, SpO2, PR, ECG, Temperature, Respiration and Optional Extra
Primary Client Use:
Intended for patient monitoring
Measurement Site:
BP: Upper Arm; SpO2: Finger
Measurement Occurrence:
BP: Single and intermittent measurements; SpO2: Single, intermittent and continuous 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 and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Blood pressure measurements are taken from the upper arm and oxygen saturation measurements are taken from the finger. 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. There appears to be no peer-reviewed clinical validation information available on the technology used in the Edan elite V5 to measure peripheral oxygen saturation.
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. 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))