Validation and Verification of the Task Force® Monitor

Abstract

The Task Force® Monitor (TFM) is a newly developed, commercially available monitoring device for the continuous measurement of blood pressure (contBP) by use of the vascular unloading technique [1, 2, 3] and beat-to-beat stroke volume (SV) measurement with impedance cardiography [2, 3, 4, 5] (ICG). ContBP is automatically corrected to oscillometric BP (oscBP) values obtained at the contralateral arm. In addition, a 2-channel ECG is included for R-R interval determination. Furthermore these beat-to-beat values are used for a real-time calculation of heart rate (HR) and BP variability (HRV, BPV) by an autoregressive model [2, 6, 7], which are displayed as 3-dimensional sliding power spectra. Additionally, an automatic evaluation of baroreceptor reflex sensitivity (BRRS) by the sequence method [8] is performed and also displayed on-line. The TFM has passed the tests for the CEquality mark (CE 0408, TUeV Austria, Vienna) For FDA 510(k), several test procedures and clinical studies were necessary. In the present paper the methods and protocols of the clinical studies are described and the results are presented. The ICG-unit of the Task Force® Monitor is considered to be substantially equivalent to the BioZ-PC (Ca rdioDynamics, San Diego, CA, USA,) and the contBP of the TFM is considered to be substantially equivalent to the Finapres (Ohmeda, Luiseville CO, USA). Therefore the TFM was compared to the above mentioned devices (Bio Z model No.BZ-410-04 11/98 SNr.: 000581001) and Finapres BP Monitor (Stock no: 6050-0000-130, SNr: FAM 000032).