A-8
Response to irregular rhythm
In compliance with the requirements in Clause 201.7.9.2.9.101
b) 4) of IEC60601-2-27, the heart rate after 20 seconds of
stabilization is displayed as follows:
Ventricular bigeminy (3a): 80±1 bpm
Slow alternating ventricular bigeminy (3b): 60±1 bpm
Rapid alternating ventricular bigeminy (3c): 120±1 bpm
Bidirectional systoles (3d): 90±2 bpm
Response time to heart rate
change
Meets the requirements of IEC60601-2-27: 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 of IEC60601-2-27: Clause
201.7.9.2.9.101 b) 6).
Waveform
4ah - range:
4a - range:
4ad - range:
Waveform 4bh - range:
4b - range:
4bd - 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 201.7.9.2.9.101 b)
2)of IEC60601-2-27, the heart rate meter will reject all 100 ms
QRS complexes with less than 1.2 mV of amplitude, and T
waves with T-wave interval of 180 ms and those with Q-T
interval of 350 ms.
Arrhythmia Analysis
Classifications
Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy,
Extreme Brady, PVCs/min, PNP, PNC, PVC, Couplet, Run
PVCs, Bigeminy, Trigeminy, R on T, Missed Beats, Brady,
Tachy, Vent. Rhythm, Multif. PVC, Nonsus. Vtac, Pause, Irr.
Rhythm., Afib, Pauses/min
ST Segment Analysis
Measurement range
-2.0 to 2.0 mV RTI
Accuracy
-0.8 to 0.8 mV:
Beyond this range:
±0.02 mV or ±10%, whichever is greater.
Not specified.
Refreshing rate
10 s
Resolution 0.01
mV
Alarn limit
Range (rpm)
Step (rpm)
ST High
(low limit + 0.2 mV) to 2.0 mV
-2.0 to 2.0 mV
0.1 mV
Summary of Contents for uMEC10
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