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24.1 ECG
ECG
Compliant standards
Lead type
Sampling rate
Skew between channels
Bandwidth
Amplitude quantisation
Waveform sweeping speed
Frequency response
Time constant
Display sensitivity
Common mode rejection ratio
Input impedance
Input signal range
Electrode polarization voltage
range
Input offset current
Baseline recovery time
Patient leakage current
System noise
Calibration voltage
Chapter 24 Technical Specifications
IEC 60601-2-27: 2011 and IEC 60601-2-25: 2011
3 leadwire: I, II or III
⚫
5 leadwire: I, II, III, aVR, aVL, aVF, V
⚫
10 leadwire: I, II, III, aVR, aVL, aVF, V1 to V6
⚫
2000Hz
≤100μs
0.05 Hz-150 Hz
4.9 µV/LSB
6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s
Error: ≤ ±5%
Diagnostic mode: 0.05 Hz-150 Hz
⚫
Monitor mode: 0.5 Hz-40 Hz
⚫
Surgery mode: 1 Hz-20 Hz
⚫
ST mode: 0.05 Hz-40 Hz
⚫
Use A and E methods based on IEC 60601-2-25 to determine frequency
response.
Monitoring mode: ≥0.3s
⚫
Diagnostic mode: ≥3.2s
⚫
1.25mm/mV (×1/8), 2.5mm/mV (×1/4), 5mm/mV (×1/2), 10mm/mV (×1),
20mm/mV (×2), 40 mm/mV (×4), Auto. Error: ±5%
Surgery mode, monitor mode, ST mode > 105dB
Diagnostic mode > 90dB
≥10 MΩ
-10.0mV - +10.0mV (peak-to-peak value)
±800 mV
≤0.1μA
<5 s after defibrillation
10μA
≤30 µV (p-v RTI)
1mV, error range ±5%
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