ECG Performance Product Specifications
29 - 16 V Series Operating Instructions
29.2 ECG Performance
Regulations
Complies with the following regulations:
• ANSI/AAMI
ES60601-1:2005/(R)2012 + A1:2012,C1:2009/(R)2012 + A2:2010/(R)2012
• AAMI/ANSI EC57:2012
• IEC 60601-2-27:2011
• IEC 60601-2-25:2011
* Accuracy of input signal reproduction: Methods A & D were used, as prescribed in section 3.2.7.2 and 4.2.7.2
of this standard, to establish overall system error and frequency response. Because of the sampling charac-
teristics and the asynchronism between sample rate and signal rate, the V 12/V 21 may produce a notice-
able modulating effect from one cycle to the next, particularly in pediatric recordings.
* Heart Rate Meter Accuracy and Response to Irregular Rhythm: Ventricular bigeminy: 80 bpm; Slow alternat-
ing ventricular bigeminy: 60 bpm; Rapid alternating ventricular bigeminy: 120 bpm; Bidirectional systoles: 90
bpm.
* Response time to HR change: From 80 to 120 bpm: less than 11 s; From 80 to 40 bpm: less than 11 s
V 12/V 21 in conjunction with:
A. VPS
1. Lead Definition
2. 3/5 Lead ECG Cable Detection
The ECG System has a manual selection for 3 or 5 leads cables when Mindray cables are used.
3. Defibrillator Overload protection
The ECG function is in accordance with the applicable requirements of IEC 60601-2-27 and IEC 60601-
2-25.
4. ECG Signal Range
• ± 5mV (peak-to-peak value); the output accuracy of signals complies with 50.102.1 of IEC60601-2-
27:2011.
5. Calibration Signal
• 1mV (peak-to-peak value)
• Accuracy: 5% or 40V, whichever is greater
6. Detected RTI Range of Measured ECG Signals
• 4.88 V, ±8 mV when gain is ×0.125, ×0.25, ×0.5, ×1, ×2, ×4.
TABLE 29-15
ECG TYPE ACQUIRED LEADS DISPLAYABLE LEADS
3-Lead ECG I, II, III I, II, III (one vector at a time)
5-Lead ECG I, II, and V (n) I, II, III, aVR, aVL, aVF, V (n)
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