Zimmer Cryo Mini - Page 35

Manufacturer´s EMC declaration
18
Page 28
Guidelines and manufacturer’s declaration – electromagnetic immunity
The CryoMini device is intended for use in the electromagnetic environment specified below. The customer or the user of the
CryoMini device should assure that it is used in such an environment.
Electromagnetic immunity
tests
IEC 60601-Test level
Compliance level
Electromagnetic environment -
guidelines
Electrostatic discharge
(ESD) acc. to IEC 61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
± 6 kV contact discharge
± 8 kV air discharge
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative air humidity must be
at least 30%.
Electrical fast transient
disturbance variables /
bursts acc. to IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input / output
lines
± 2 kV for power supply
lines
Not applicable for input
and output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surges
according to IEC 6100-4-5
± 1 kV differential mode
voltage
± 2 kV common-mode
voltage
± 1 kV differential mode
voltage
± 2 kV common-mode
voltage
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and voltage
variations of power supply
acc. to IEC 61000-4-11
<5% U
T
(>95% dip in UT for ½
cycle)
40% U
T
(60% dip in U
T
for 5 cycles)
70% U
T
(30% dip in U
T
for 25
cycles)
<5% U
T
(>95% dip in UT for 5
seconds)
<5% U
T
(>95% dip in UT for ½
cycle)
40% U
T
(60% dip in U
T
for 5
cycles)
70% U
T
(30% dip in U
T
for 25
cycles)
<5% U
T
(>95% dip in UT for 5
seconds)
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of CryoMini requires continued
operation also during power
mains interruptions, it is
recommended that CryoMini be
powered from an uninterruptable
power supply or a battery.
Magnetic field at the power
frequency (50/60 Hz)
according to IEC 61000-4-8
3 A/m
3 A/m
Magnetic fields at this power
frequency should be at levels
characteristic of a location in a
typical commercial or hospital
environment.
Note: U
T
is the AC mains voltage prior to application of the test level.