Accu-Chek Spirit Combo - Immunity Electromagnetic Fields

183
A
Table 203: Immunity electromagnetic elds (life-supporting devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specied below. The customer or
the user of the Accu-Chek Spirit Combo 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 Spirit Combo 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 to 2.7
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