GE CARESCAPE ONE User Manual page 298

CARESCAPE ONE User Manual DRAFT 26 October 2017
Parameter specifications
ECG heart rate averaging
ECG heart rate display update interval
ECG QRS detection range
ECG QRS detection width
PVC rate range
PVC rate resolution
ST numeric range
ST numeric resolution
ST numeric accuracy
QRS numeric accuracy
VEB numeric accuracy
VF numeric accuracy
ECG gain selections
ECG signal gain accuracy
Sampling rate
ECG display bandwidth (based on ECG
waveform filter setting)
Diagnostic and Monitoring (at 60 Hz
powerline frequency) bandwidths tested
from 0.67 to 40 Hz as per IEC 60601-2-27
Clause 201.12.1.101.8
Moderate and maximum bandwidths
not tested from 0.67 to 40 Hz as per IEC
60601-2-27 Clause 201.12.1.101.8
298
12-second median HR values
●
12-second HR median calculation extended to a maximum of
●
32 seconds based on signal noise when software package is
ICU, ED, OR, or PACU
< 2 seconds
±0.5 to ±5 mV
40 to 120 ms (Q to S)
0 to 300 PVCs per minute
1 PVC per minute
-20.0 to 20.0 mm
0.1 mm
Per EC57 (ESC database):
ST Mean Absolute Difference < 100 µV
●
ST Mean Difference (Mean error) < 50 µV
●
Correlation coefficient > 0.90
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ST tolerance ± 0.4 mm or 20%, whichever is greater
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Per EC57 (AHA and MIT-BIH databases):
QRS sensitivity >97.5%
●
QRS positive predictivity: >97.5%
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Per EC57 (AHA and MIT-BIH databases):
VEB sensitivity >90%
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VEB positive predictivity: >90%
●
Per EC57 (AHA and MIT-BIH databases):
VF episode sensitivity >95%
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VF episode positive predictivity: >95%
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0.5x = 5 mm/mV
1x = 10 mm/mV
2x = 20 mm/mV
4x = 40 mm/mV
±5%
500 samples/second
Diagnostic: 0.05 to 150 Hz
●
Monitoring:
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50 Hz powerline frequency: 0.05 to 32 Hz
￭
60 Hz powerline frequency: 0.05 to 40 Hz
￭
Moderate: 0.05 to 23 Hz
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Maximum: 4.5 to 27 Hz
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CARESCAPE ONE 2094480-001