Fresenius Medical Care 2008T Operator's Manual page 273

Guidance and manufacturer's declaration – electromagnetic immunity
The 2008T hemodialysis machine is intended for use in the electromagnetic environment specified below. The
customer or the user of the 2008T hemodialysis machine should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
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/cordless) 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 2008T hemodialysis
machine is used exceeds the applicable RF compliance level above, the 2008T hemodialysis machine should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the 2008T hemodialysis machine.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
2008T Machine Operator's Manual P/N 490122 Rev N
Compliance level Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the 2008T hemodialysis machine,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
If abnormal performance is observed such as
TMP alarms or blood leak alarms, additional
measures may be necessary, such as re-
orienting or relocating the equipment.
Recommended separation distance
1.2 P
3 Vrms
150 kHz to 80 MHz
3 V/m 1.2 P
80 MHz to 2.5 GHz
2.3 P
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey,
level in each frequency range.
Interference may occur in the
vicinity of High Frequency Surgical
Equipment (such as
electrocautery devices) or other
intentional radio frequency
emitting equipment typically
marked with the following symbol:
Appendix C
80 MHz to 800 MHz
800 MHz to 2.5 GHz
a
should be less than the compliance
b
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