Zimmer Gentle Pro, Instructions For Use Manual

Page: 39 / 44

Manufacturer’s EMC declaration 16
Page 28
Table 2
Guidance and Manufacturing Declaration- Electromagnetic Immunity
The device Gentle
Pro
is intended for use in the electromagnetic environment specified below. The customer or user
of the device Gentle
Pro
should ensure that it is used in such environment.
Immunity
Tests IEC 60601- Test Level Compliance Level Electromagentic Environment -
Guidlines
Elctrostatic
Discharge
(ESD) in
accordance
with IEC
61000-4-2
± 8 kV Contact Discharge
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV Air Discharge
± 8 kV Contact Discharge
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV Air Discharge
Floors should be made from wood,
concrete or ceramic tiles. If floor are
covered with synthetic material, the
relative humidity must be at least 30 %
Electrical
fast
transient/
burst in
accordance
with IEC
61000-4-4
± 2 kV
100 kHz repetition
frequency
± 2 kV
100 kHz repetition frequency
The supply voltage quality must
correspond to that of a typical
commercial or hospital
environment.
Surges in
accordance
with IEC
6100-4-5
-Line-to-
Line-
± 0,5 kV, ± 1 kV ± 0,5 kV, ± 1 kV
Surges in
accordance
with IEC
6100-4-5
-Line-to-
Earth-
± 0,5 kV, ± 1 kV, ± 2 kV ± 0,5 kV, ± 1 kV, ± 2 kV
Voltage dips
in
accordance
with IEC
61000-4-11
0 % U
T;
0,5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % U
T;
0,5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
The supply voltage quality must
correspond to that of a typical
commercial or hospital environment. If
the user of the device Gentle
Pro
requires
continued operation, even in the case of
interruptions in the power supply, it is
recommended that the device Gentle
Pro
be powered from an uninterrupted
power supply or a battery.
0 % U
T;
1 cycle and 70%
U
T;
25/30 cycles
Single phase: at 0°
0 % U
T;
1 cycle and 70% U
T;
25/30 cycles
Single phase: at 0°
Voltage
interruptions
accordance
with IEC
61000-4-11
0% U
T;
250/300 cycle 0% U
T;
250/300 cycle
Magnetic
filed of
supply
30 A/m
50 Hz oder 60 Hz
30 A/m
50 Hz
Magnetic fields at mains frequency
should have the typical values found in
a business or hospital environment.