Zimmer Cryo 7, Instructions For Use Manual, Page: 43 / 45

Manufacturer’s EMC declaration
16
Page 33
Table 3
Guidelines and manufacturer’s declaration –
Electromagnetic immunity
The Cryo 7 device is intended to be used in the electromagnetic environment as indicated below. The customer or
user of the Cryo 7 device must ensure that it is used in such an environment.
Immunity test IEC 60601
–
test level
Compliance level Electromagnetic environment
–
Guidelines
Conducted disturbances by
HF fields according to IEC
61000-4-6 3 V
0.15 MHz
–
80
MHz
6 V in ISM
band between
0.15 MHz and
80 MHz
80% AM at 1
kHz
3 V
0.15 MHz
–
80 MHz
6 V in ISM band between 0.15 MHz
and 80 MHz
80% AM at 1 kHz
In the environment of devices
which bear the following
symbol, interferences are
possible:
Radiated electromagnetic HF
fields according to IEC 61000-
4-3 3 V/m
80 MHz
–
2.7
GHz
80% AM to
1 kHz
3 V/m
80 MHz
–
2.7 GHz
80% AM at 1 kHz