Validation of the STEP deflation algorithm of the Midmark IQvitals Zone Vital Signs Monitor: part of a novel clinical ecosystem

Abstract

Objectives: Assess the accuracy of the Midmark IQvitals Zone Vital Signs Monitor STEP deflation algorithm according to the ANSI/AAMI/ISO 81060-2 Standard.

Methods: A total of 85 subjects completed the testing protocol. All standard requirements for gender, blood pressure (BP) values, and arm circumferences were met. Manual auscultation was performed by testers blinded to the device; the manual BP values were compared to the device readings.

Results: The Standard Criterion 1 data analyses showed mean ± SD device minus manual BP values of 1.22 ± 6.3 mmHg for SBP and -1.67 ± 6.09 mmHg for DBP. The SD values for criterion 2 were 5.06 mmHg (SBP) and 4.98 mmHg (DBP).

Conclusions: The device passed all Standard requirements. The Midmark IQvitals Zone device has features to improve accuracy and reduce or eliminate transcription errors and inaccuracy from improper patient positioning.