We have located links that may give you full text access.
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 Pressure Monitoring 2024 Februrary 19
OBJECTIVE: To validate the noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor with reference invasive blood pressure monitoring equipment for clinical use in adults, adolescents or children according to the International Organization for Standardization (ISO) 81060-2:2018 standard.
METHODS: Patients were recruited, and the ipsilateral sequential method was used for blood pressure measurement according to the standard. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference invasive blood pressure results.
RESULTS: A total of 71 patients were included in the study, with 35 and 36 patients for each iFAST and iCUFS mode, respectively. The validation results showed an average device-reference difference of -3.27 ± 5.60 mmHg for SBP and -0.09 ± 6.10 mmHg for DBP for the iFAST mode, and -2.04 ± 5.55 mmHg for SBP and -0.79 ± 5.86 mmHg for DBP for the iCUFS mode, respectively, which passed the criteria of the ISO 81060-2 : 2018 in adults, adolescents or children population for both SBP and DBP.
CONCLUSION: The noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor passed all the requirements of ISO 81060-2:2018 and can be recommended for clinical use in adults, adolescents, or children.
METHODS: Patients were recruited, and the ipsilateral sequential method was used for blood pressure measurement according to the standard. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference invasive blood pressure results.
RESULTS: A total of 71 patients were included in the study, with 35 and 36 patients for each iFAST and iCUFS mode, respectively. The validation results showed an average device-reference difference of -3.27 ± 5.60 mmHg for SBP and -0.09 ± 6.10 mmHg for DBP for the iFAST mode, and -2.04 ± 5.55 mmHg for SBP and -0.79 ± 5.86 mmHg for DBP for the iCUFS mode, respectively, which passed the criteria of the ISO 81060-2 : 2018 in adults, adolescents or children population for both SBP and DBP.
CONCLUSION: The noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor passed all the requirements of ISO 81060-2:2018 and can be recommended for clinical use in adults, adolescents, or children.
Full text links
Related Resources
Trending Papers
Ten tips to manage oral anticoagulation in hemodialysis patients with atrial fibrillation.Clinical Kidney Journal 2024 October
New strategies for the treatment of hyperkalemia.European Journal of Internal Medicine 2024 November 2
Mixed Cardiogenic Shock: A Proposal for Standardized Classification, a Hemodynamic Definition, and Framework for Management.Circulation 2024 October 29
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app