Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The MiniMed 640G insulin pump is intended for use in the electromagnetic
environment specified below. The customer or user of the MiniMed insulin pump
should assure that it is used in such an electromagnetic environment.
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
broadcasts 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 MiniMed insulin pump is used exceeds the applicable RF compliance level above,
the insulin pump should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or
relocating the MiniMed insulin pump.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10
V/m.
266 Chapter 15
MP6025957-024 / A
RELEASED
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