Sigma Spectrum Infusion Pump User Manual

Immunity – Separation DistancesRecommended separation distance betweenportable and mobile RF communications equipment and the SpectrumThe SIGMA Model Spectrum is intended for use in an electromagnetic environment in which the RDdisturbances are controlled. The customer or user of the Spectrum can help prevent electromagneticinterference by maintaining a minimum distance between the portable and mobile RF communicationsequipment (transmitters) and the Spectrum as recommended below, according to the maximum output power ofthe communications equipment.Rated maximumoutput power oftransmitterWSeparation distance according to frequency of transmitterm150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHzoutside ISMin ISM bandsbands__d = 1.2√P__d = 1.2√P__d = 1.2√P__d = 2.3√P0.01 0.12 0.12 0.12 .230.1 0.38 0.38 0.38 .731 1.2 1.2 1.2 2.310 3.8 3.8 3.8 7.3100 12 12 12 23For transmitters rated at maximum output power not listed above, the recommended separation distance d in meters (m) canbe determined using the equation applicable to the frequency of the transmitter, where power P is the maximum output powerrating 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 theISM frequency band between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihoodthat 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 reflectionfrom structures, objects and people.WARNING:The Spectrum pump is not designed to be exposed to linear accelerator radiation nor isit intended to be used in this manner. Exposure to radiation of this type may cause thedevice to operate improperly.Do not expose the SIGMA Spectrum to linear accelerator radiation. Doing so may causeinjury to the patient and/or damage to the equipment.- 54 -