Getinge PulsioFlex NICCI
Device Name:
PulsioFlex NICCI
Manufacturer:

Distributer: Getinge AB, Lindholmspiren 7A, P.O. Box 8861, SE-417 56 Göteborg, SWEDEN.

Other: Pulsion Medical Systems SE, Hans-Riedl-Str. 21, 85622 Feldkirchen, GERMANY.

Measuring functions:
Blood pressure
Primary Client Use:
Module intended as a component of a patient monitor
Measurement Site:
Finger
Measurement Occurrence:
Continuous measurement
Availability:
Available Currently
Description:
The Getinge PulsioFlex NICCI is an automatic blood pressure monitor. Although its blood pressure measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood pressure measurements are taken from the finger. It is intended for use in a bedside patient monitor.
Assessment:
The technology used in the Getinge PulsioFlex NICCI, to measure blood pressure, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been assessed, in a specific population, according to a non-standard protocol.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
Validation Publications:

Bekiroglu I, Owusu-Bediako K, Rice-Weimer J, Tobias JD. An Evaluation of the NICCI Monitor in Providing Continuous, Noninvasive Blood Pressure Readings in Children During Intraoperative Anesthetic Care. J Clin Med Res. 2022 Apr;14(4):158-164. Epub: 2022 Apr 30. doi: 10.14740/jocmr4723. PMID: 35573930. Available from: PMC9076136.

IA protocol Children (n=24). IA validation (Note: During general anaesthesia)

Owusu-Bediako K, Bekiroglu I, Rice-Weimer J, Murillo-Deluquez M, Tobias JD. Noninvasive Blood Pressure Measurement Using the NICCI Monitor in Adolescents During Intraoperative Anesthetic Care. Cardiol Res. 2022 Jun;13(3):154-161. Epub: 2022 Jun 2. doi: 10.14740/cr1378. PMID: 35836736. Available from: PMC9239505.

SP10:2002 - Fail Children and adolescents (n=44). IA validation (Note: During general anaesthesia)

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