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The Hillrom Connex Vital Signs 6000 Series is a vital signs monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for bedside patient monitoring.
Assessment:
The technology used in the Hillrom Connex Vital Signs 6000 Series, to measure blood pressure, has been validated in its own right, but equivalence still needs to be confirmed to ensure compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy Assessment Recommendation Basis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
Device Family:
Welch Allyn Connex ProBP 3400 with SureBPA, Hillrom Connex Vital Signs 6000 SeriesA, Welch Allyn SureBP Algorithm (Unspecified Device)A, Hillrom Connex SpotA, Hillrom Spot Vital Signs 4400A
Legend: A Same validated algorithm
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Welch Allyn Connex ProBP 3400 with SureBP
Alpert BS. Validation of the Welch Allyn ProBP 3400: a device for modern medical practice. Blood Press Monit. 2011 Jun;16(3):156-8. doi: 10.1097/MBP.0b013e328346d61b. PMID: 21527848.
SP10:2002 - Pass General population (Note: Cirterion 1 only (n=92))
Welch Allyn SureBP Algorithm (Unspecified Device)
Alpert BS. Validation of the Welch Allyn SureBP (inflation) and StepBP (deflation) algorithms by AAMI standard testing and BHS data analysis. Blood Press Monit. 2011 Apr;16(2):96-8. doi: 10.1097/MBP.0b013e328345232f. PMID: 21412074.
SP10:2006 - Pass General population
