Guidance And Manufacturer's Declaration - Electromagnetic Immunity; Part I - Medtronic Xomed Hydrodebrider Bedienungsanleitung

Guidance and manufacturer's declaration – electromagnetic
immunity

Part I

The Xomed® Hydrodebrider® System is intended for use in the electromagnetic environment specified below. The customer or the user of the Xomed®
Hydrodebrider® System should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions and
voltage variations on power supply input
lines
IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
The Xomed® Hydrodebrider® System is intended for use in the electromagnetic environment specified below. The customer or the user of the Xomed® Hydrodebrider®
System should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations
IEC 61000-3-3
Recommended separation distances between portable and mobile RF communications equipment and the Xomed® Hydrodebrider®
The Xomed® Hydrodebrider® System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of
the Xomed® Hydrodebrider® System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Xomed® Hydrodebrider® System as recommended below, according to the maximum output power of the communications equipment.
Rated maximum power of
transmitter
W
0.01
0.10
1.00
10.00
100.00
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Xomed® Hydrodebrider® System
Guidance and manufacturer's declaration – electromagnetic immunity – Part I
IEC/EN60601-1-2
Compliance level
test level
±6 kV contact ±6 kV contact
±8 kV air ±8 kV air
±2 kV for power supply lines ±2 kV for power supply lines
±1 kV for input/output lines ±1 kV for input/output lines
±1 kV differential mode ±1 kV differential mode
±2 kV common mode ±2 kV common mode
<5 % UT (>95 % dip in UT) for <5 % UT (>95 % dip in UT) for
0.5 cycle 0.5 cycle
40 % UT (60 % dip in UT) for 40 % UT (60 % dip in UT) for
5 cycles 5 cycles
70 %UT (30 % dip in UT) for 70 % UT (30 % dip in UT) for
25 cycles 25 cycles
<5 % UT (>95 % dip in UT) <5 % UT (>95 % dip in UT) for
for 5 sec 5 sec
3 A/m 3 A/m
Guidance and manufacturer's declaration – electromagnetic emissions
Compliance
Group 1
Class A
Class A
Complies
Separation distance according to frequency of transmitter meters
150 kHz to 80 MHz 80 MHz to 800 MHz
d = 1.2√P
0.12
0.38
1.20
3.80
12.00
Electromagnetic environment - guidance
Floors should be wood, concrete, or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30 %.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
Xomed® Hydrodebrider® System requires continuous
operation during power mains interruptions, it is
recommended that the Xomed® Hydrodebrider®
System be powered from an uninterruptible power
supply or a battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
Electromagnetic environment - guidance
The Xomed® Hydrodebrider® System uses RF energy only for its
internal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment
The Xomed® Hydrodebrider® System is suitable for use in all
establishments, other than domestic and those directly connected to
the public low-voltage power supply network that supplies buildings for
domestic purpose.
800 MHz to 2.5 GHz
d = 1.2√P
0.12
0.38
1.20
3.80
12.00
d = 2.3√P
0.23
0.73
2.30
7.30
23.0
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