BeneVision N1 Patient Monitor Operator’s Manual A - 11
Response to irregular rhythm In compliance with the requirements in Clause 201.7.9.2.9.101 b) 4) of IEC
60601-2-27: 2011, the heart rates for the specified test signals after 20 seconds
of stabilization are:
Ventricular bigeminy (waveform A1): 80±1 bpm
Slow alternating ventricular bigeminy (waveform A2): 60±1 bpm
Rapid alternating ventricular bigeminy (waveform A3): 120±1 bpm
Bidirectional systoles (waveform A4): 90±2 bpm
Response time to heart rate change Meets the requirements of IEC 60601-2-27: 2011: Clause 201.7.9.2.9.101 b) 5).
From 80 to 120 bpm: less than 11 s
From 80 to 40 bpm: less than 11 s
Time to alarm for tachycardia Meets the requirements in Clause 201.7.9.2.9.101 b) 6) of IEC 60601-2-27:
2011.
Waveform
B1h-range:
B1-range:
B1d-range:
B2h-range:
B2-range:
B2d-range:
< 11 s
< 11 s
< 11 s
< 11 s
< 11 s
< 11 s
Tall T-wave rejection capability When the test is performed based on Clause 201.12.1.101.17 of IEC 60601-2-
27: 2011, the heart rate calculation is not affected for QRS of 1 mV amplitude
and 100 ms duration, T-wave duration of 180 ms and amplitude lower than 1.2
mV, and QT interval of 350 ms.
Arrhythmia Analysis Classifications Asystole, V-Fib/V-Tach, V-Tach, Vent Brady, Extreme Tachy, Extreme Brady, Vent
Rhythm, PVCs/min, Pauses/min, Couplet, Bigeminy, Trigeminy, R on T, Run
PVCs, PVC, Tachy, Brady, Missed Beat, Pacer Not Pacing, Pacer Not Capture,
Multiform PVC, Nonsus V-Tach, Pause, Irr Rhythm, A-Fib
ST Segment Analysis
Measurement range -2.0 mV to 2.0 mV RTI
Accuracy -0.8 mV to 0.8 mV:
Beyond this range:
±0.02 mV or ±10%, whichever is greater.
Not specified.
Refreshing rate 10 s
Resolution 0.01mV
QT/QTc Analysis
Measurement range QT: 200 to 800 ms
QTc: 200 to800 ms
QT-HR: 15 bpm to 150 bpm for adult, 15 bpm to 180 bpm for pediatric and
neonate
Accuracy QT: ±30 ms
Resolution QT: 4 ms
QTc: 1 ms
12-lead ECG Interpretation
Sampling rate 1000 samples/s (waveform)
500 samples/s (algorithm)
Amplitude quantisation 24 bits
Alarm limit Range Step