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 rate after 20 seconds of stabilization is displayed
as follows:
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-Tac, V-Tac, Vent Brady, Extreme Tachy, Extreme Brady, Vent
Rhythm, PVCs/min, Pauses/min, Couplet, Bigeminy, Trigeminy, R on T, Run
PVCs, PVC, Tachy, Brady, Missed Beats, 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.
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
PVCs/min
Measurement range
Adult: 0 to 300
Pediatric, neonate: 0 to 350
Alarm limit
Range
Step