Technical Specifications; Accuracies - ZOLL CMCT Monitoring System Instructions For Use Manual

10 TECHNICAL SPECIFICATIONS

10.1 ACCURACIES

Parameter Measurement Accuracy
Error of less than 50cc fluid at a confidence level of 90%
TFC*
Accuracy higher than ±2 bpm or ±2%, the higher of the two
HR
RR Maximum error of ±2 bpm or 10% , the higher of the two
Activity Active vs resting accuracy > 99%
Walking time in hours per day. Error less than ±10% or ±5
minutes, the larger of the two.
Posture classification accuracy > 90%
Posture
• QRS Sensitivity >99% PPV> 99%**
Arrhythmias
• VEB : Sensitivity > 94.9% PPV>93% **
• AF: Sensitivity > 93% PPV>86%***
* As measured in experiments conducted in the laboratory
** Based on algorithm testing preformed using the AHA Database for Evaluation of Ventricular
Arrhythmia Detectors
*** Based on algorithm testing preformed using the MIT-BIH Arrhythmia Database
NOTE: Probability of acquiring p-waves signal is higher at the front location
Heart Rate Calculation
The CMCT system algorithm detects the peak of each R-wave and calculates the time interval
between successive R peaks known as the RR interval. Heart Rate is calculated based on a 60
second moving average time window. For each window where valid ECG was detected, Heart
Rate is computed in bpm as 60 divided by the average RR interval.
Pause Detection
The CMCT system algorithm is based on QRS detection. An RR interval longer than a
configurable threshold is a potential pause. Verified intervals are declared as pause.
CMCT Monitoring System
Instructions for Use
Page 24 of 31