Zimmer PhySys - Page 61

Manufacturer's EMC declaration
20
Page 54
Guidelines and manufacturer's declaration – Electromagnetic immunity
The PhySys device is intended to be operated in the electromagnetic environment as indicated below. The customer or user
of the PhySys device should ensure that it is used in such an environment.
Immunity tests
IEC 60601- test level
Compliance level
Electromagnetic environment -
Guidelines
Electrostatic discharge
(ESD) according to IEC
61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
± 6 kV contact discharge
± 8 kV air discharge
Floors should be made of wood or
concrete or should be covered
with ceramic tiles. If the floor is
covered with synthetic material,
the relative air humidity must be at
least 30%.
Rapid transient electrical
disturbances / bursts
according to IEC 61000-
4-4
± 2 kV for power cables
± 1 kV for input and output
cables
± 2 kV for power cables
Not applicable for input and
output cables
The quality of the supply voltage
should correspond to that of a
typical business or hospital
environment.
Surges
according to IEC 6100-4-
5
± 1 kV differential mode
± 2 kV common mode
± 1 kV differential mode
± 2 kV common mode
The quality of the supply voltage
should correspond to that of a
typical business or hospital
environment.
Voltage dips, brief
interruptions and
fluctuations in the supply
voltage according to IEC
61000-4-11.
<5% U
T
(>95% dip in the U
T
for ½
cycle)
40% U
T
(60% dip in the U
T
for 5
cycles)
70% U
T
(30% dip in the U
T
for 25
cycles)
<5% U
T
(>95% dip in the U
T
for 5
seconds)
<5% U
T
(>95% dip in the U
T
for ½
cycle)
40% U
T
(60% dip in the U
T
for 5
cycles)
70% U
T
(30% dip in the U
T
for 25
cycles)
<5% U
T
(>95% dip in the U
T
for 5
seconds)
The quality of the supply should
correspond to that of a typical
business or hospital environment.
If the user of the PhySys requires
continued function even if
interruptions in the power supply
occur, it is recommended to power
PhySys from an uninterruptible
power supply or a battery.
Magnetic field at power
supply frequency (50/60
Hz) according to IEC
61000-4-8
3 A/m
3 A/m
Magnetic fields at the mains
frequency should correspond to
the typical values found in a
business or hospital environment.
Note: U
T
is the a.c. supply voltage prior to application of the test level.
Table 202 according to EN 60601-1-2:2006-10