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Test Solution for
IEC 60601-2-47

WhaleTeq offers ECG/EKG test solutions compliant with international medical standard of IEC60601-2-47, including SECG 4.0 for performance tests, MECG 2.0 for database playback, CMRR 3.0+ for common mode rejection ratio tests and RDCA software for rhythm database compliance analysis.


IEC60601-2-47:2012 (AMBULATORY ECG)
Test Clause SECG 4.0 MECG 2.0 CMRR 3.0+ RDCA The accuracy of QRS detection   O   O The accuracy of heart rate measurements   O   O The accuracy of VEB detection   O   O Claime to detect ventricular flutter or fibrillation (VF)   O   O Claimed to detect supraventricular ectopic beats, or atrial flutter or fibrillation (AF), claimed to measure ST SEGMENT deviations or to detect ST SEGMENT changes   O   O Required statistics   O   O Requirements for all arrhythmia algorithms   O   O Requirements for algorithms with optional capabilities   O   O Simulated test patterns   O   O Use of standard databases   O   O Use of annotation files   O   O Beat-by-beat comparison   O   O General description   O   O Method for beat-by-beat comparison   O   O Heart rate, and heart rate or RR interval variability   O   O Heart rate measurement   O   O Heart rate variability or RR interval variability measurement test Patterns   O   O Run-by-run comparison   O   O General description   O   O Terms and symbols   O   O Run sensitivity summary matrix   O   O Run positive predictivity summary matrix   O   O VF and AF comparisons   O   O Physician report – minimum requirements   O   O Heart rate   O   O Supraventricular ectopy   O   O Ventricular ectopy   O   O Bradycardia data   O   O PAUSES   O   O ST SEGMENT shifts   O   O ECG hard copy   O   O Incorrect output O Linearity and dynamic range O Input impedance O Common mode rejection     O GAIN accuracy O GAIN stability O System noise     O Multichannel crosstalk O Frequency response O Function in the presence of pacemaker pulses O Timing accuracy O GAIN settings and switching O Temporal alignment O      

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