Specifications
52 Affinity® 4 Birthing Bed Instructions for Use (USR025 REV 13)
Guidance and Manufacturer's Declaration - Electromagnetic Immunity - Continued
The P3700 Affinity® 4 Birthing Bed is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user should make sure it is used in such an environment.
Immunity
Test
EN and IEC
60601-1-2
Test Level
EMC
Compliance
Level
Electromagnetic Environment—Guidance
Conducted-RF
IEC 61000-4-6
Radiated-RF
IEC 61000-4-3
3 Vrms (80%
AM)
150 KHz to
80 MHz
(see Note 1)
3 Vrms (80%
AM) 150 KHz
to 80 MHz(6
Vrms in ISM
Bands per
CISPR-11) see
Note 2)
3 V/m
80 MHz to
2500 MHz
(see Note 1)
3 V/m
80 MHz to
2700 MHz
(see Note 2)
3 Vrms (80%
AM)
150 KHz to
80 MHz
(see Note 1)
3 Vrms (80%
AM) 150 KHz
to 80 MHz(6
Vrms in ISM
Bands per
CISPR-11) see
Note 2)
3 V/m
80 MHz to
2500 MHz
(see Note 1)
3 V/m
80 MHz to
2700 MHz
(see Note 2)
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey (see Note 5), should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with this symbol.
Note 1: Corresponding information shown is with respect to the 3
rd
Edition of EN/IEC 60601-1-2 and is relevant for all
P3700 Affinity® 4 units having serial numbers beginning with and up to T242AA.
Note 2: Corresponding information shown is with respect to the 4
th
Edition of EN/IEC 60601-1-2 and is relevant for all
P3700E Affinity® 4 units having serial numbers beginning with and after T242AA.
Note 3: U
T
is the AC mains voltage prior to application of the test level.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, object, and people.
Note 5: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast can not 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 P3700 Affinity® 4 bed is used exceeds
the applicable RF compliance level above, the P3700 Affinity® 4 bed should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
P3700 Affinity® 4 bed.
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