Appendix I ECG Automated Measurement&Interpretation Guide
1. Preface
The appendix describes the functions of ECG automated measurement and automated
interpretation. It explains the specific implementation method, algorithm and formulas related to
these two functions, as well as the content output by the automated measurement and automated
interpretation.
According to the requirement of IEC60601-2-51:2003 Medical electrical equipment - Part
2-51: Particular requirements for safety, including essential performance, of recording and
analysing single channel and multichannel electrocardiographs, Clause 50 Accuracy of
operating data, the appendix gives a description of verification process and results of the
performance for automated measurement and automated interpretation.
2. Automated measurement parameters and Automated interpretation items
The output measurement parameter, interpretation item and others that require explanation
are as follows:
2.1 Measurement parameters
No.
1
2
3
4
5
6
7
8
9
2.2 Interpretation items
No.
1
2
3
4
5
6
7
8
Parameter
HR
PR-interval
P-duration
QRS-duration
T-duration
QT/QTc
P/QRS/T electric axis
R(V5)/S(V1)
R(V5)+S(V1)
Item
No abnormal
Sinus mode Bradycardia
Sinus mode Tachycardia
Left atrium Hypertrophy
Right atrium Hypertrophy
Dual atrium Hypertrophy
QRS low voltage
Cardiac electric axis normal
39
Unit
bpm
ms
ms
ms
ms
ms
deg
mV
mV