IEC60601-2-47:2012 (AMBULATORY ECG)

SECG MECG CMRR Box The accuracy of QRS detection x The accuracy of heart rate measurements x The accuracy of VEB detection x Claime to detect ventricular flutter or fibrillation (VF) x Claimed to detect supraventricular ectopic beats, or atrial flutter or fibrillation (AF), claimed to measure ST SEGMENT deviations or to detect ST SEGMENT changes x Required statistics x Requirements for all arrhythmia algorithms x Requirements for algorithms with optional capabilities x Simulated test patterns x Use of standard databases x Use of annotation files x Beat-by-beat comparison x General description x Method for beat-by-beat comparison x Heart rate, and heart rate or RR interval variability x Heart rate measurement x Heart rate variability or RR interval variability measurement test Patterns x Run-by-run comparison x General description x Terms and symbols x Run sensitivity summary matrix x Run positive predictivity summary matrix x VF and AF comparisons x Physician report – minimum requirements x Heart rate x Supraventricular ectopy x Ventricular ectopy x Bradycardia data x PAUSES x ST SEGMENT shifts x ECG hard copy x Incorrect output x Linearity and dynamic range x Input impedance x Common mode rejection x GAIN accuracy x GAIN stability x System noise x Multichannel crosstalk x Frequency response x Function in the presence of pacemaker pulses x Timing accuracy x GAIN settings and switching x Temporal alignment x