Roche Accu-Check Insight, User Manual

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Table 203: Immunity electromagnetic fields (life-supporting devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The Accu-Chek Insight insulin pump is intended for use in the electromagnetic environment specified below. The customer or the
user of the Accu-Chek Insight insulin pump should assure that it is used in such an environment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of the Accu-Chek Insight insulin pump,
including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the
transmitter.
Immunity test standard IEC 60601 test level Compliance level Recommended separation distance c)
Conducted RF
IEC 61000-4-6 3 Vrms
150 kHz to 80 MHz V1 = 10 Vrms 150 kHz
to 80 MHz
d = 1.2√
−
P
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3 10 V/m
80 MHz to 800 MHz E1 = 10 V/m 80 MHz
to 800 MHz
d = 1.2√
−
P
80 MHz to 800 MHz
Radiated RF
IEC 61000-4-3 10 V/m
800 MHz to 2.5 GHz
d) E2a = 2 V/m for
2.3 GHz to
2.5 GHz
e) E2b = 10 V/m for
800 MHz to
2.3 GHz and
2.5 GHz to
2.7 GHz
da = 11.7√
−
P
2.3 GHz to 2.5 GHz
db = 2.3√
−
P
800 MHz to 2.3 GHz and
2.5 GHz to 2.7 GHz