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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 cust omer or user of the Spectrum should assure that it is used in such an environment.
Imm unity test
IEC 60601 test
le vel
Compli-
ance
level
Electroma gnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrm s
150 kHz to 80 M Hz
in ISM bands a
10 Vrm s
150 kHz to 80 M Hz
in ISM bands
a
10 V/m
80 M Hz to 2.5 GHz
3 Vrms
10 Vrms
10 V/m
Portable and mo bile RF com mu nications equipme nt
should be used no closer to any part of the
Spectrum , including cables, than the recomm ended
separation distance calcu lated from the e quation
applicable to the frequency of the transmitter.
Recommende d separation distance
__
80 M Hz to 800 MHz
800 M Hz to 2.5 GHz
Wh ere P is th e m aximum output power rating of the
transmitter in watts (W) according to the tran smitter
manufacturer and d is the recom mended separation
distance in meters (m ).
b
Field strengths from fixed RF transmitters, as
determ ined by an electromagn etic site survey,
c
should be less than the compliance level in each
frequen cy range.
d
Interference may occur in the vicinity of the
equipment m arked with th e following symbol: : “This
excludes the Wireless Battery Modules, SIGM A Part
Number 35083 and 3 5162”
d
1.2 P
=
d
1.2 P
=
d
1.2 P
=
d
2.3 P
=