SOLUTIONS
-ECG / EKG STANDARD
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.
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 |
SECG 5.0 AIO
The ECG simulator designed for ECG performance testing. Capable of adding noise,...
MECG 2.0
The ECG database player designed for system validation and software algorithm evaluat...
CMRR 3.0+
The CMRR tester combining accuracy,convenience and test automation all together. C...
SECG Assistant Software
Enhanced software pack for SECG 4.0 to increase the test efficiency with less effort...
RDCA Database Comparison Software
A quick tool to compare database test result and perfect algorithm. Standard Coverage ...
TRF Generator
The ultimate test solution for compliance testing - Simplify all your efforts conducti...
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