156 Appendix E: Electromagnetic Compatibility
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
Immunity – Separation Distances
WARNING Linear Accelerator Radiation.
The SIGMA Spectrum Infusion System is not designed to be exposed
to linear accelerator radiation nor is it intended to be used in this
manner. Exposure to radiation of this type may cause the device to
operate improperly.
Do not expose the SIGMA Spectrum Infusion System to linear
accelerator radiation. Doing so may cause injury to the patient and/or
damage to the equipment.
Recommended separation distance between portable and mobile RF communications equipment and
the equipment or system – for all life-supporting equipment and systems
The SIGMA Spectrum Infusion System is intended for use in an electromagnetic environment in which the RF disturbances
are controlled. The customer or user of the Pump can help prevent electromagnetic interference by maintaining a minimum
distance between the portable and mobile RF communications equipment (transmitters) and the Pump as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
outside ISM bands
150 kHz to 80 MHz in
ISM bands
80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.12 .23
0.1 0.38 0.38 0.38 .73
1 1.2 1.2 1.2 2.3
10 3.8 3.8 3.8 7.3
100 12 12 12 23
For transmitters rated at maximum output power not listed above, the recommended separation distance d in meters (m)
can be determined using the equation applicable to the frequency of the transmitter, where power 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 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.756 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
NOTE 3 An additional factor of 10/3 is used in calculating the recommended separation distance for the transmitters in the
ISM frequency band between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the
likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient
areas.
NOTE 4 The guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
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