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Supplement for medical Use
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided below.
Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING : The use of accessories, transducers and cables other than those specified,with the exception of transducers
and cables sold by the manufacturer of the equipment or system as replacement parts for internal
components ,may result in increase emissions or decreased immunity of the equipment or system.
Information of Cables and Accessories
Make sure to use specified Accessories as described in the user manual P/N 1000-400-802, in order to maintain
compliance with IEC60601-1-2.
WARNING : The equipment or system should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary,the equipment or system should be observed to verify normal
operation in the configuration in which it will be used. Prior to using it in a surgical procedure, consult the
tables below for guidance in placing the equipment.
WARNING : The use accessories, transducer or cable with equipment or system other than those specified may result
in increased emissions or decreased immunity of the equipment or system.
Guidance and Manufacturer's declaration-electromagnetic emissions
The customer or the user of the Model 240-020-505 should assure that it is used in such an environment.
The Model 240-020-505 is intended for use in the electromagnetic environment specified below.
Emission Test
Compliance
RF emissions
Group 1
CISPR11/EN55011
RF emissions
Class B
CISPR11/EN55011
Harmonic emissions
Class A
IEC/EN 61000-3-2
Voltage Fluctuations/
Complies
Flicker emissions
IEC/EN 61000-3-3
Electromagnetic environment-guidance
The Model 240-020-505 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 Model 240-020-505 is suitable for use in all establishments,
including domestic establishments and those directly connected
to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Guidance and Manufacturer's declaration-electromagnetic immunity
The Model 240-020-505 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Model 240-020-505 should assure that it is used in such an environment.
Immunity Test
IEC/EN 60601
Test Level
Electrostatic
+/- 6 kV : Contact
discharges(ESD)
+/- 8 kV : Air
IEC/EN 61000-4-2
Electrical fast
+/- 2 kV : AC mains
Transients/burst
+/- 1 kV : Signal lines
IEC/EN 61000-4-4
Surge
+/- 2 kV : Common mode
IEC/EN 61000-4-5
+/- 1 kV : Differential mode
<5 % Ut
Voltage dips, short
(>95 % dip in 100 V and
interruptions and
voltage variations
240 V) : for 0.5 cycle
on power supply
input lines
40 % Ut
(60 % dip in 100 V and
240 V) : for 5 cycles
IEC/EN 61000-4-11
70 % Ut
(30 % dip in 100 V and
240 V) : for 25 cycles
<5 % Ut
(>95 % dip in 100 V and
240 V) : for 5 s
3 A/m
Power frequency
(50 Hz/60 Hz)
Magnetic Field
IEC/EN 61000-4-8
Compliance Level
Electromagnetic
environment-guidance
+/- 6 kV : Contact
Floor should be wood, concrete or
+/- 8 kV : Air
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30 %.
+/- 2 kV : AC mains
Mains power quality should be that
+/- 1 kV : Signal lines
of a typical commercial or hospital
environment.
+/- 2 kV : Common mode
Mains power quality should be that
+/- 1 kV : Differential mode
of a typical commercial or hospital
environment.
<5 % Ut
Mains power quality should be that
(>95 % dip in 100 V and
of a typical commercial or hospital
240 V) : for 0.5 cycle
enviroment. If the user of the Model
240-020-505 requires continued
40 % Ut
operation during power mains
(60 % dip in 100 V and
interruptions, it is recommended that
240 V) : for 5 cycles
the Model 240-020-505 be powered
from an uninterruptible power supply
70 % Ut
or a battery.
(30 % dip in 100 V and
240 V) : for 25 cycles
<5 % Ut
(>95 % dip in 100 V and
240 V) : for 5 s
3 A/m
If image distortion occurs, it may be
necessary to position the Model 240-
020-505 further from sources of
power frequency magnetic fields or
to install magnetic shielding.
The power frequency magnetic field
should be measured in the intended
installation location to assure that it
is sufficiently low.
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