Zimmer Cryo 6 Instructions For Use Manual page 45

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Manufacturer´s EMC declaration
Guidelines and manufacturer's declaration – Electromagnetic immunity
The Cryo 6 device is intended to be operated in the electromagnetic environment as indicated below. The customer or user
of the Cryo 6 device should ensure that it is used in such an environment.
Immunity tests
IEC 60601-
test level
Electrostatic
± 6 kV contact
discharge (ESD)
discharge
according to IEC
61000-4-2
± 8 kV air
discharge
Rapid transient
± 2 kV for
electrical
power cables
disturbances/bursts
according to IEC
± 1 kV for input
61000-4-4
and output
cables
Surges
± 1 kV
according to IEC
differential
6100-4-5
mode
± 2 kV
common mode
Voltage dips, brief
<5% U
T
interruptions and
(>95% dip in
fluctuations in the
the U
for ½
T
supply voltage
cycle)
according to IEC
61000-4-11.
40% U
T
(60% dip in the
U
for 5 cycles)
T
70% U
T
(30% dip in the
U
for 25
T
cycles)
<5% U
T
(>95% dip in
the U
for 5
T
seconds)
Magnetic field at
3 A/m
power supply
frequency (50/60
Hz) according to
IEC 61000-4-8
Note: U
is the a.c. supply voltage prior to application of the test level.
T
Compliance
Electromagnetic environment - Guidelines
level
± 6 kV contact
Floors should be made of wood or concrete or should be covered
discharge
with ceramic tiles. If the floor is covered with synthetic material,
the relative air humidity must be at least
± 8 kV air
30%.
discharge
± 2 kV for power
The quality of the supply voltage should correspond to that of a
cables
typical business or hospital environment.
± 1 kV for input
and output
cables
± 1 kV
The quality of the supply voltage should correspond to that of a
differential mode
typical business or hospital environment.
± 2 kV common
mode
<5% U
The quality of the supply should correspond to that of a typical
T
(>95% dip in the
business or hospital environment. If the user of the Cryo 6
U
for ½ cycle)
requires continued function even if interruptions in the power
T
supply occur, it is recommended to power Cryo 6 from an
40% U
uninterruptible power supply or a battery.
T
(60% dip in the
U
for 5 cycles)
T
70% U
T
(30% dip in the
U
for 25 cycles)
T
<5% U
T
(>95% dip in the
U
for 5
T
seconds)
3 A/m
Magnetic fields at the mains frequency should correspond to the
typical values found in a business or hospital environment.
19
Page 38

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