Appendix E: Electromagnetic Compatibility
155
SIGMA Spectrum Infusion System
Pump Operating Software Version 8.00
Operator’s Manual
For Use With MDL Version 8.0
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
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.
b
The ISM compliance level in the ISM frequency band between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5
GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas. For this reason, an additional factor of 3K is used in calculating the recommended
separation distance for transmitters in these frequency ranges.
c
Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio,
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 Pump is used exceeds the applicable RF compliance level above, the Pump
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the Pump.
d
Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.