
A-6
Input signal range ±8mV (peak-to-peak value)
Accuracy of input signal
reproduction
Methods A and D were used to establish overall system error and
frequency response according to EC11.
Auxiliary current (Leads
off detection)
Active electrode: < 0.1 μA
Reference electrode: < 1 μA
Patient leakage current < 10uA
Recovery time after
defibrillation
< 5s
Calibration signal
1 mV (peak-to-peak value), precision: ±5%
ESU protection Incision mode: 300W
Congelation mode: 100W
Restore time: ≤10s
The monitor complies with the requirements of ANSI/AAMI
EC13 Section 4.2.9.14.
ESU noise control The monitor uses the ECG leads meeting the requirements of
AAMI; based on the ECG baseline, the peak noise ≤ 2mV
The monitor complies with the test method in EC13 Section
5.2.9.14.
HR
Measurement range
Neonate:
Pediatric:
Adult:
15 to 350 bpm
15 to 350 bpm
15 to 300 bpm
Resolution 1 bpm
Precision ±1 bpm or ±1%, whichever is greater.
Trigger threshold level 200 μV (lead II)
Trigger indication There will be an audible beep on every beat captured.
Heart Rate Averaging The average Heart Rate is computed in line with the ANSI/AAMI
EC13 Section 4.1.2.1 d) as follows:
When the last 3 R-to-R intervals > 1200 ms, compute the average
of the last 4 R-to-R intervals; otherwise, compute the average of
the last 12 R-to-R intervals minus the longest and shortest
intervals.
The displayed Heart Rate is updated once per second.
Heart Rate Meter
Accuracy and Response to
Irregular Rhythm
When tested in accordance with the ANSI/AAMI EC13 Section
4.1.2.1 e), the indicated heart rate after a 20 second stabilization
period is:
Figure 3a (Ventricular Bigeminy) -80±1 bpm
Figure 3b (Slow Alternating Ventricular Bigeminy) -60±1 bpm
Figure 3c (Rapid Alternating Ventricular Bigeminy) -120±1bpm
Figure 3d (Bi-directional Systoles) -90±2 bpm
Response time to heart rate
changes
Meets the requirement of ANSI/AAMI EC13: Section 4.1.2.1 f).
Less than 11 sec for a step increase from 80 to 120 BPM
Less than 11 sec for a step decrease from 80 to 40 BPM
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