Trio™ Operating Instructions 0070-10-0666-01 6 - 7
Appendix Patient Parameter Specifications
6.2.3 ANSI/AAMI EC13-2002 Compliance
The ECG meets the section 4.2 Performance Requirements of ANSI/AAMI EC13-2002
except for paragraph 4.2.9.13, Synchronizing Pulse for Cardioversion, which is not
applicable.
6.2.3.1 Disclosed Performance Specifications
Tall T-Wave Rejection: When tested in accordance with ANSI/
AAMI EC13-2002 section 4.1.2.1 c), the
heart rate meter will reject all T-waves with
amplitudes less than 120% of a 1 mV, 100
ms QRS, and a T wave duration of 180 ms
and a Q-T interval of 350 ms.
Heart Rate Averaging: ANSI/AAMI EC13-2002 section 4.1.2.1 d).
The Heart Rate Averaging computation is as
follows: The average of the last 4 R-to-R
intervals, when last 3 R-to-R intervals > 1200
ms. Otherwise, the average of the last 12 R-
to-R intervals, minus the maximum and
minimum values. The update rate of the
Heart Rate on the display is once per
second.
Heart Rate Meter Accuracy and Response to
Irregular Rhythm:
When tested in accordance with ANSI/
AAMI EC13-2002 section 4.1.2.1 e), the
indicated heart rate after a 20 second
stabilization period is:
Figure 3a (Ventricular Bigeminy) - 80 bpm
Figure 3b (Slow Alternating Ventricular
Bigeminy) - 60 bpm
Figure 3c (Rapid Alternating Ventricular
Bigeminy) - 120 bpm
Figure 3d (Bi-directional Systoles) - 90 bpm
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