154 Appendix E: Electromagnetic Compatibility
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
Immunity – Conducted and Radiated
Guidance and manufacturer’s declaration – electromagnetic immunity –
for all life-supporting equipment and systems
The SIGMA Spectrum Infusion System is intended for use in the electromagnetic environment specified below. The customer or
user of the Pump should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
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
b
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 Pump, 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 Module, Baxter P/N
35162.
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