86 APPENDIX E - Electromagnetic Compatibility
SIGMA Manual Number 41018
Revision AR
Immunity – Conducted and Radiated
Guidance and manufacturer’s declaration – electromagnetic immunity
The SIGMA Model Spectrum Infusion pump is intended for use in the electromagnetic environment specified
below. The customer or user of the Spectrum should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compli-
ance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
in ISM bands a
10 Vrms
150 kHz to 80 MHz
in ISM bands
a
10 V/m
80 MHz to 2.5 GHz
3 Vrms
10 Vrms
10 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the
Spectrum, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
__
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
c
should be less than the compliance level in each
frequency range.
d
Interference may occur in the vicinity of the
equipment marked with the following symbol: : “This
excludes the Wireless Battery Modules, SIGMA Part
Number 35083 and 35162”
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