Appendix B
Category
Certification and Compliance
UL:
FCC:
Industry Canada:
EN:
Monitoring Modes
Fetal Heart Rate:
Uterine Activity:
Maternal Heart Rate:
Ultrasound Mode
Technique:
Transducer Type:
Leakage Current:
I
at the transducer face
(sata)
Entrance beam dimensions (A
Center frequency (f
)
c
Pulse duration
Pulse repetition frequency
Global maximum value of total
acoustic power (W
)
0
Spatial-average pulse-average
intensity
Measurement uncertainties
-
I
(sata)
-
Ultrasonic power (W
-
Center frequency (f
*These parameters calculated as X + Ks where X is the mean value of the measurement, s = the standard deviation of the
measured values, and K = 4.258 (K chosen for 90% confidence for 90% of the population for a sample size of 3).
44
Technical Specifications
UL 60601-1
United States FCC 47 CFR Part 95
Canadian RSS-210
European EN 300-220-1
Ultrasound (US) and FECG
External Tocotransducer (TOCO) or Internal Intrauterine Pressure
Catheter (IUPC)
Maternal ECG (MECG)
Pulsed Doppler with autocorrelation processing
9-crystal
< 100 µA, isolated by transducer (TYPE BF)
2.7 mW/cm2*
)
10.18 cm2
aprt
1.151 MHz ± 40 Hz
92.5 µs
2 kHz ± 8 Hz
27.5 mW*
14.6 mW/cm2 < 20 mW/cm2 ( FDA limit)
± 7%
± 7%
)
0
± 5%
)
c
2049809-001
Rev B
Transmitter
© 2010 by General Electric Company. All rights reserved.
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