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.
Moreover, WhaleTeq TRF Generator software is the ultimate test solution for compliance testing - simplify all your efforts conducting testing and generating TRF report. Work with SECG 5.0 AIO, SECG 4.0, CMRR 3.0+ and CMRR 3.0.
Test Clause | SECG 5.0 AIO | MECG 2.0 | CMRR 3.0+ | RDCA |
---|---|---|---|---|
201.12.1.101.1.2.1 The accuracy of QRS detection | O | O | ||
201.12.1.101.1.2.2 The accuracy of heart rate measurements | O | O | ||
201.12.1.101.1.2.3 The accuracy of VEB detection | O | O | ||
201.12.1.101.1.2.4 Claime to detect ventricular flutter or fibrillation (VF) | O | O | ||
201.12.1.101.1.2.5 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 | ||
201.12.1.101.1.5.1 Required statistics | O | O | ||
201.12.1.101.1.5.2 Requirements for all arrhythmia algorithms | O | O | ||
201.12.1.101.1.5.3 Requirements for algorithms with optional capabilities | O | O | ||
201.12.1.101.1.6 Simulated test patterns | O | O | ||
201.12.1.101.2.1 Use of standard databases | O | O | ||
201.12.1.101.2.2 Use of annotation files | O | O | ||
201.12.1.101.2.3 Beat-by-beat comparison | O | O | ||
201.12.1.101.2.3.1 General description | O | O | ||
201.12.1.101.2.3.2 Method for beat-by-beat comparison | O | O | ||
201.12.1.101.2.3.3.1 Heart rate measurement | O | O | ||
201.12.1.101.2.4 Run-by-run comparison | O | O | ||
201.12.1.101.2.4.1 General description | O | O | ||
201.12.1.101.2.4.2 Terms and symbols | O | O | ||
201.12.1.101.2.4.3 Run sensitivity summary matrix | O | O | ||
201.12.1.101.2.4.4 Run positive predictivity summary matrix | O | O | ||
201.12.1.101.2.5 VF and AF comparisons | O | O | ||
201.12.1.101.3 Physician report – minimum requirements | O | O | ||
201.12.1.101.3.1 Heart rate | O | O | ||
201.12.1.101.3.2 Supraventricular ectopy | O | O | ||
201.12.1.101.3.3 Ventricular ectopy | O | O | ||
201.12.1.101.3.4 Bradycardia data | O | O | ||
201.12.1.101.3.5 PAUSES | O | O | ||
201.12.1.101.3.6 ST SEGMENT shifts |
O | |||
201.12.1.101.3.7 ECG hard copy | O | O | ||
201.12.1.101.2.3.3.2 Heart rate variability or RR interval variability test Patterns |
O | |||
201.12.4.4 Incorrect output | O | |||
201.12.4.4.101 Linearity and dynamic range | O | |||
201.12.4.4.102 Input impedance | O | |||
201.12.4.4.103 Common mode rejection | O | |||
201.12.4.4.104 GAIN accuracy | O | |||
201.12.4.4.105 GAIN stability | O | |||
201.12.4.4.106 System noise | O | |||
201.12.4.4.107 Multichannel crosstalk | O | |||
201.12.4.4.108 Frequency response | O | |||
201.12.4.4.109 Function in the presence of pacemaker pulses | O | |||
201.12.4.4.110 Timing accuracy | O | |||
201.12.4.4.111 GAIN settings and switching | O | |||
201.12.4.4.112 Temporal alignment | O |