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A.5.3 Resp Specifications
A.5.4 SpO
2
Specifications
Mindray SpO
2
Module
Response time to heart rate change Meets the requirements of IEC 60601-2-27: Clause 201.7.9.2.9.101 b) 5).
From 80 to 120 bpm:
From 80 to 40 bpm:
less than 11 s
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.
Waveform
4ah - range:
4a - range:
4ad - range:
4bh - range:
4b - range:
4bd - range:
<11 s
<11 s
<11 s
<11 s
<11 s
<11 s
Arrhythmia Analysis Classifications Asystole, V-Fib/V-Tach, PNP, PNC
Tall T-wave rejection capability When the test is performed based on Clause 201.12.1.101.17 of IEC 60601-2-
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.
Lead-off detection current ≤0.1 A
Baseline recovery time <2.5 s (after defibrillation, in therapy mode)
Response to irregular rhythm In compliance with the requirements in Clause 201.7.9.2.9.101 b) 4) of IEC
60601-2-27, 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
Technique Trans-thoracic impedance
Measurement range 0 to 200 rpm
Resolution 1 rpm
Accuracy 121 to 200 rpm:
0 to 120 rpm:
±2 rpm
±1 rpm
Respiration excitation waveform <300 µA, sinusoid, 62.8 kHz (±10%)
Minimum respiration impedance
threshold
0.3 with× 5 gain
Bandwidth 0.2 to 2.5 Hz (-3 dB)
Reference impedance range 2200 to 4500, using an ECG cable with 1 k resistor
Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s
Standard Meet standards of ISO 80601-2-61
Measurement range 0 to 100%
Resolution 1%
Response time <20 s (SpO
2
value sudden changes from 70% to 100%)
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