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