Comen N10 - Page 252

Product Specifications
II-6
Extreme Tachy: 60 bpm～300 bpm
Extreme Brady: 15bpm～120 bpm
Step
1 bpm for the range of 15bpm~40bpm,
5 bpm for 41bpm～300bpm
Tall T-wave rejection
1.2mV
Average HR calculation
As required in Section 201.7.9.2.9.101 b) 3) of IEC 60601-2-27, the average HR is
calculated as follows. If all of the last 3 RR intervals are longer than 1200ms, the
average of the last 4 RR intervals is the HR. In other cases, the average of the last
12 RR intervals (with the longest interval and shortest interval excluded) is the HR.
Alarm delay for cardiac
standstill (asystole) and
high/low HR
<10s
Heart rate accuracy and
response to arrhythmia
As required in Section 201.7.9.2.9.101 b) 4) of IEC 60601-2-27, the HR is displayed
as follows after the 20s stable segment:
Figure 3 a) (bigeminy): 80±1bpm
Figure 3 b) (slowly varying bigeminy): 60±1bpm
Figure 3 c) (quickly varying bigeminy): 120±1bpm
Figure 3 d) (two-way contraction): 90±2bpm
Response time for HR
changes
As required in Section 201.7.9.2.9.101 b) 5) of IEC 60601-2-27: the response time
for a HR change, whether from 80bpm to 120bpm or from 80bpm to 40bpm, is
less than 10s.
Time to alarm for
Tachycardia
As required in Section 201.7.9.2.9.101 b) 6) of IEC 60601-2-27, the waveform:
Figure 4 a) 1 - range: 10s
Figure 4 a) 0.5 - range: 10s
Figure 4 a) 2 - range: 10s
Figure 4 b) 1 - range: 10s
Figure 4 b) 0.5 - range: 10s
Figure 4 b) 2 - range: 10s
Resting 12-lead ECG interpretation
Method
Multiple lead- ECG analysis
ECG sampling and amplitude
quantisation
ECG sampling rate
1000 Hz
Skew vetween channels
Less than 100µs
Amplitude quantisation
≤5µV/LSB
ECG report output
Heart rate(bpm), PR interval (ms), QRS duration (ms), QT/QTC interval (ms),
P/QRS/T axes(°), RV5/SV1, RV5+SV1, RV6/SV2.
Pacer pulse
Pacemaker pulse rejection
without overshoot
Amplitude: ±2mV~±700mV; width: 0.1ms~2.0ms; overshoot is less than 0.05a
q
,
stabilization period is less than 5µs; the rise time and fall time of pulse not exceed
100µs; the pulse is applied preceding 40ms or less the QRS wave onset; the atrial
pacemaker pulse precedes a ventricular pacemaker pulse by 150ms to 250 ms.
Pacemaker pulse rejection of
fast ECG signals
Min. input slew rate: 2.2V/s±15%RTI (pacer mode)
Pacing pulse indication
No less than 0.2mV referred to input