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Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/wireless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the F15 Series Fetal & Maternal Monitors are used exceeds the applicable RF
compliance level above, the F15 Series Fetal & Maternal Monitors should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the F15 Series Fetal & Maternal Monitors.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz
to6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70
MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to
4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz,
18.07 MHz to 18.17 MHz,21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz
and 50.0 MHz to 54.0 MHz.
Table-Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications
Test
Brand
Frequency
(MHz)
(MHz)
385
380-390
450
430-470
710
745
704-787
780
810
870
800-960
930
1720
1845
1700-1990
1970
2450
2400-2570
5240
5500
5100-5800
5785
Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting
014_14.1_F15_Series_User_Manual
a)
a)
Service
TETRA 400
GMRS 460,
FRS 460
LTE Brand 13,
17
GSM
800/900,TETRA
800, iDEN 820,
CDMA 850, LTE
Band 5
GSM 1800;
CDMA 1900;
GSM 1900;
DECT; LTE
Band 1, 3, 4,25;
UMTS
Bluetooth,
WLAN,802.11
b/g/n, RFID
2450, LTE
Brand 7
WLAN 802.11
a/n
equipment
Modulation
Maximum
b)
Power(W)
Pulse
b)
modulation
1.8
18Hz
C)
FM
± 5 kHz
2
deviation
1kHz sine
Pulse
b)
modulation
0.2
217 Hz
Pulse
b)
modulation
2
18 Hz
Pulse
b)
modulation
2
217 Hz
Pulse
b)
modulation
2
217 Hz
Pulse
b)
modulation
0.2
217 Hz
- 166 -
EMC Information
IMMUNITY
Distance
TEST LEVEL
(m)
(V/m)
0.3
27
0.3
28
0.3
9
0.3
28
0.3
28
0.3
28
0.3
9
182／202
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