A - 9
A.13
Measurement Specifications
The adjustable range of alarm limits is the same with the measurement range of signals unless otherwise
specified.
A.13.1
ECG Specifications
ECG
Standards
Meet standards of IEC 60601-2-27 and IEC 60601-2-25
Lead set
3-lead:
5-lead:
6-lead:
12-lead:
I, II, III
I, II, III, aVR, aVL, aVF, V
I, II, III, aVR, aVL, aVF, Va, Vb
I, II, III, aVR, aVL, aVF, V1 to V6
ECG standard
AHA, IEC
Display sensitivity
1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1),
20 mm/mV (×2), 40 mm/mV (×4), Auto, less than 5% error
Sweep speed
6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s, less than 5% error
Bandwidth (-3dB)
Diagnostic mode:
Monitor mode:
Surgical mode:
ST mode:
High Freq Cut-off (for
12-lead ECG analysis)
0.05 to 150 Hz
0.5 to 40 Hz
1 to 20 Hz
0.05 to 40 Hz
350 Hz, 150 Hz, 35 Hz, or 20 Hz, selectable
Common mode rejection ratio
Diagnostic mode:
Monitor mode:
Surgical mode:
ST mode:
>90 dB
>105 dB (with notch filter on)
>105 dB (with notch filter on)
>105 dB (with notch filter on)
Notch filter
50/60 Hz
Monitor, surgical, and ST mode: notch filter turns on automatically
Diagnostic mode and High Freq Cut-off: notch filter is turned on/off
manually
Differential input impedance
≥5 MΩ
Input signal range
±10 mV (peak-to-peak value)
Accuracy of signal reproduction
Use A and D methods based on IEC 60601-2-25 to determine frequency
response.
Electrode offset potential tolerance
±800 mV
Lead-off detection current
Measuring electrode: <0.1 μA
Drive electrode: <1 μA
Input offset current
≤0.1 μA, (drive lead≤1μA)
Defibrillation protection
Enduring 5000V (360 J) charge without data loss or corruption
Baseline recovery time: <5 s (after defibrillation)
Polarization recovery time: <10 s
Defibrillation energy absorption: ≤10% (100Ω load)
Patient leakage current
<10 uA
Calibration signal
1mV (peak-to-peak value) ±5%
ESU protection
Cut mode: 300 W
Coagulate mode: 100 W
Recovery time: ≤10 s
In compliance with the requirements in clause 202.6.2.101 of IEC 60601-2-27
Pace Pulse
Summary of Contents for ePM 10M
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