Fresenius Medical Care 2008K Operator's Manual page 225

Guidance and manufacturer's declaration – electromagnetic immunity
The 2008K hemodialysis machine is intended for use in the electromagnetic environment specified below. The customer or the user
of the 2008K 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 2008K hemodialysis machine is used exceeds the applicable RF
compliance level above, the 2008K 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 2008K hemodialysis
machine.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
portable and mobile RF communications equipment and the 2008K hemodialysis machine
The 2008K hemodialysis machine is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the 2008K hemodialysis machine can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 2008K
hemodialysis machine as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of
transmitter
W
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
2008K Hemodialysis Machine Operator's Manual Rev P
Compliance Electromagnetic environment – guidance
level
Portable and mobile RF communications equipment should be used
no closer to any part of the 2008K 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
3 Vrms 1.2 P
150 kHz to
80 MHz
1.2 P
3 V/m
2.3 P
80 MHz to
where P is the maximum output power rating of the transmitter in
2.5 GHz
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:
Recommended separation distances between
Separation distance according to frequency of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz
d = 1.2 P d = 1.2 P
0.12
0.38
1.2
3.8
12
80 MHz to 800 MHz
800 MHz to 2.5 GHz
a should be less than the compliance
b
m
0.12
0.38
1.2
3.8
12
Machine Specifications
800 MHz to 2.5 GHz
d = 2.3 P
0.23
0.73
2.3
7.3
23
225