A - 14
A.8.2 ECG Specifications (from Therapy Accessories)
Measurements Heart rate, PR interval, QRS duration, QT/QTc interval, P/QRS/T axis and
diagnosis statement
Patient connection Paddles or multifunction electrode pads
ECG inputs Paddles or Pads
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), 40mm/mV (×4), Auto, less than ± 5% error
Sweep speed 6.25mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s, less than ± 5% error
Bandwidth (-3dB) Therapy mode: 1 to 20 Hz
Common mode rejection Therapy mode: >105 dB (with notch filter on)
Notch filter Therapy mode: 50/60Hz, notch filter turns on automatically.
Differential input impedance ≥5 M
ECG signal range ±8mV (peak-to-peak value)
Calibration signal 1mV (peak-to-peak value) ±5%
Electrode offset potential tolerance ±1V
Lead-off detection current ≤0.1 A
Baseline recovery time <2.5 s (after defibrillation)
Defibrillation protection Enduring 5000V (360 J) charge without data loss or corruption
Baseline recovery time: <2.5 s (after defibrillation)
Polarization recovery time: <10 s
Defibrillation energy absorption: ≤10% (100 load)
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
Pace pulse markers Pace pulses meeting the following conditions are labelled with a PACE
marker:
Amplitude:
Width:
Rise time:
No overshoot
±2 to ± 700 mV
0.1 to 2 ms
10 to 100 µs (no greater than 10% of pulse
width)
Pace pulse rejection When tested in accordance with the IEC 60601-2-27: 201.12.1.101.13, the
heart rate meter rejects all pulses meeting the following conditions.
Amplitude:
Width:
Rise time:
No overshoot
±2 to ± 700 mV
0.1 to 2 ms
10 to 100 µs
HR
Measurement range Adult:
Pediatric
15 to 300 bpm
15 to 350 bpm
Accuracy ±1% or ±1bpm, which ever is greater
Resolution 1 bpm
Sensitivity 200 V