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Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The Paradigm 523/723/523K/723K pump is intended for use in the electromagnetic environment

specified below. The customer or user of the Paradigm 523/723/523K/723K pump system should

make sure that it is used in such an environment.

Immunity

Test IEC 60601

Level

Compliance

Level Electromagnetic Environment Guidance

NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption, and reflection from structures, objects and people.

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 access 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 Paradigm 523/723/523K/723K pump is used exceeds the applicable RF compliance

level above, the Paradigm 523/723/523K/723K 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 Paradigm 523/723/523K/723K pump.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V

] V/m.

Pump specifications202

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Medtronic Revel Betriebsanweisung Seite 223