St. Jude Medical SJM Confirm DM2100A, User Manual

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SJM Confirm™ Patient Activator User’s Manual 21
Test IEC 60601 Test Level
1
1. At 80 MHz and 800 MHz, the higher frequency range applies.
Immunity Compliance Level
Electromagnetic Environment – Guidance
Radiated RF IEC
61000-4-3 3 V/m
80 MHz to 2.5 GHz 3 V/m
Portable and mobile RF communications equipment should be used no closer to the PA, including
cables, than the recommended separation distance.
Recommended separation distance:
(80 MHz to 800 MHz)
(800 MHz to 2.5 GHz)
where P is the maximum output power rating of the PA in watts (W) according to the PA manufacturer
and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey
2
, should be
less than the compliance level in each frequency range. Interference may occur in the vicinity of
equipment marked with the following symbol:
Table 3. Guidance and manufacturer’s declaration – electromagnetic immunity (radiated RF)
d 1.2 P =
d 1.2 P =
d 2.3 P =