A - 10 BeneVision N1 Patient Monitor Operator’s Manual
Accuracy of signal reproduction Use A and D methods based on IEC 60601-2-25: 2011 to determine frequency
response.
Electrode offset potential tolerance ±500 mV
Lead-off detection current Measuring electrode: <0.1 A
Drive electrode: <1 A
Input offset current ≤0.1 A, (drive lead≤1A)
Defibrillation protection Withstands 5000V (360 J) charge without data loss or corruption
Baseline recovery time: <5 s
Polarization recovery time: <10 s
Defibrillation energy absorption: ≤10% (100
Ω 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:
2011
Pace Pulse
Pace pulse markers Pace pulses meeting the following conditions are labeled with a PACE marker:
Amplitude:
Width:
Rise time:
No overshoot
±2 mV to ±700 mV
0.1 ms to 2 ms
10 s to 100 s (< 10% of pulse width)
Pace pulse rejection When tested in accordance with the IEC 60601-2-27: 2011: 201.12.1.101.13,
the heart rate meter rejects all pulses meeting the following conditions.
Amplitude:
Width:
Rise time:
No overshoot
±2mV to ±700 mV
0.1ms to 2 ms
10s to 100 s (< 10% of pulse width)
HR
Measurement range Neonate: 15 to 350 bpm
Pediatric: 15 to 350 bpm
Adult: 15 to 300 bpm
Resolution 1 bpm
Accuracy ±1 bpm or ±1%, whichever is greater.
Sensitivity 200 V (lead II)
Minimum QRS detection threshold Adult and pediatric: 0.16 – 0.48 mV
Neonate: 0.12 – 0.40 mV
HR averaging method In compliance with the requirements in Clause 201.7.9.2.9.101 b) 3) of IEC
60601-2-27: 2011, the following method is used:
If the last 3 consecutive RR intervals are greater than 1200 ms, the 4 most
recent RR intervals are averaged to compute the HR. Otherwise, heart rate is
computed by subtracting the maximum and minimum ones from the most
recent 12 RR intervals and then averaging the remaining 10 RR intervals.
The HR value displayed on the monitor screen is updated no more than one
second.
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