Gima PC-900 - Chapter 6 Technical Specifications; 6.1 ECG Monitoring

45
Chapter 6 Technical Specifications
6.1 ECG Monitoring
1. Input signals range in amplitude: ± (0.5 mVp ~ 5 mVp)
2. Heart rate display range: 15 bpm ~ 350 bpm
3. Heart rate display accuracy: ± 1% or ± 2 bpm, whichever is greater.
4. Heart rate averaging: Averages the recent eight beats having RR intervals falling within the acceptable limits.
5. Heart rate alarm delay time: ≤ 10s
6. Response time to change in heart rate:
Change from 80 bpm to 120 bpm: < 8 sec
Change from 80 bpm to 40 bpm: < 8 sec
7. Tall T-wave rejection: Rejects all T-wave less than or equal to 120% of 1mV QRS.
8. Sensitivity selection:
×1/4, 2.5mm/mV tolerance: ± 5%
×1/2, 5mm/mV tolerance: ± 5%
×1, 10mm/mV tolerance: ± 5%
×2, 20mm/mV tolerance: ± 5%
9
. Sweeping speed: 25mm/s tolerance: ±10%
10
. ECG noise level: ≤ 30µV
P-P
.
11. ECG input loop current: ≤ 0.1µA
12
. Differential input impedance: ≥ 10MΩ
13. Common-mode rejection ratio (CMRR): ≥105dB
14
. Time constant: ≥ 3.2s for enhance mode ≥ 0.3s for normal mode
15
. Frequency response: 0.05Hz~40 Hz for enhance mode 0.5Hz~40Hz for normal mode
Additional declarations to conform the particular standard of IEC 60601-2-27 “Medical electrical
equipment – Part 2-27: Particular requirements for the safety, including essential performance, of
electrocardiographic monitoring equipment”
Direct current for respiration,
leads-off sensing, and active
noise suppression
Applied current less than 0.1 microamperes.
Response to irregular rhythm
A1 Ventricular bigeminy-80BPM
A2 Slow alternating ventricular bigeminy-60BPM
A3 Rapid alternating ventricular bigeminy-120BPM
A4 Bidirectional systoles-90BPM
Time to ALARM
for tachycardia
Waveform B1, Amplitude
0.5 mV
1 mV
2mV
Average Time to Alarm
<8 sec
<8 sec
<8 sec
Waveform B2, Amplitude
1mV
2mV
4mV
Average Time to Alarm
<8 sec
<8 sec
<8 sec