.
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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.
Parameter
Unit
1
HR
bpm
2
PR-interval
ms
3
P-duration
ms
4
QRS-duration
ms
5
T-duration
ms
6
QT/QTc
ms
7
P/QRS/T electric axis
deg
8
R(V5)/S(V1)
mV
9
R(V5)+S(V1)
mV
2.2 Interpretation items
No.
Item
1
No abnormal
2
Sinus mode Bradycardia
3
Sinus mode Tachycardia
4
Left atrium Hypertrophy
5
Right atrium Hypertrophy
6
Dual atrium Hypertrophy
7
QRS low voltage
8
Cardiac electric axis normal
9
Left axis deviation
