Electromagnetic Compatibility - KCI V.A.C. VIA Gebrauchsanweisung

Electromagnetic Compatibility:

Electromagnetic Interference - Although this equipment conforms with the intent of the directive
89/336/EEC in relation to Electromagnetic Compatibility (EMC), all electrical equipment may
produce interference. If interference is suspected, move equipment away from sensitive devices or
contact the manufacturer.
The Essential Performance requirements of the Model 60300 are to maintain 125mmHg +/- 15
mmHg (30 second average) vacuum pressure with no false alarms.
Portable and mobile RF communications equipment can effect medical electrical equipment.
Radios, cell phones and similar devices may affect this equipment and should be kept at least 6.5
feet (2 meters) away from the equipment.
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information in the following tables.
The following tables document compliance levels and guidance from the IEC 60601-1-2 2007
Standard, for the electromagnetic environment in which the V.A.C.Via
used in a clinical environment. The V.A.C.Via
guidance for Electromagnetic Compatibility related to use in the home care environment (IEC
60601-1-11 2007-11-30 draft).
The V.A.C.Via Therapy Unit was tested under model 60300 for EMC.
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Guidance and manufacturer's declaration - electromagnetic emissions
The V .A.C.Via ™ Therapy Unit is intended for use in the electromagnetic environment specified below. The customer or user of the V .A.C.Via
Therapy Unit should assure that it is used in such an environment.
Emission
test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
The VACVIA is suitable for use in all establishments, including domestic establishments and those directly connected
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to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer's declaration - electromagnetic immunity
The V.A.C.Via ™ Therapy Unit is intended for use in the electromagnetic environment specified below. The customer or user of the V .A.C.Via
Therapy Unit 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 < 5% X* for 5 seconds
IEC 61000-4-11
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
Therapy Unit also meets the intent of the draft
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Compliance
The V .A.C.Via
Group 1 Therefore, its RF emissions are very low and are not likely to cause any
Class B
Class B
complies
IEC 60601 Compliance Level
Test Level
±6 kV contact ±6 kV Contact
±8 kV air
±2 kV
for power supply lines for power supply lines
±1 kV
for input/output lines for input/output lines
±1 kV line to line ±1 kV line to line
±2 kV line to earth ±2 kV line to earth
< 5% X* for .5 cycle < 5% X* for .5 cycle
< 40% X* for 5 cycle < 40% X* for 5 cycle
< 70% X* for 25 cycle < 70% X* for 25 cycle
< 5% X* for 5 seconds
3 A/m
NOTE: X* is the a.c. mains voltage prior to application of the test level.
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Therapy Unit should be
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Electromagnetic environment
Therapy Unit uses RF energy only for its internal function.
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interference in nearby electronic equipment.
Electromagnetic Environment
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
±8 kV Air relative humidity should be at least 30%
±2kV
Mains power quality should be that of a typical
±1kV 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 V.A.C.Via Therapy Unit requires continued
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operation during power mains interruptions, it
is recommended that the V.A.C.Via
Unit be powered from an uninterruptible power
supply or battery.
Power frequency magnetic fields should be at
3 A/m levels characteristic of a typical location in a typical
commercial or hospital environment.
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Guidance
Therapy
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