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6.6 Important information
If multiple KaWe examination lights are used at once, the total irradi-
ance may exceed 1,000 W/m² due to superposition of the luminous
fields. As a result, there is a risk that the illuminated field may become
very hot. The superposition of the luminous fields of multiple KaWe
examination lights may cause the limit values for UV radiation (<400
nm) of 10 W/m² to be exceeded.
The report on the factory test for electrical safety can be obtained
upon request. The only requirement is the serial number of the KaWe
examination light for which the protocol is desired. If other KaWe ex-
amination lights or other pieces of equipment are connected together
during installation, section 16 of EN 60601-1:2013 applies and if nec-
essary, the compliance with the requirements is to be verified. Before
initial operation, the installation must be inspected in accordance with
EN 62353.
When installing the KaWe examination light, the polarity is very
important. Should the KaWe examination light not work after instal-
lation, during troubleshooting, the polarity can be switched on the
secondary side of the power supply.
9. ELECTROMAGNETIC COMPATIBILITY TABLES AND INFORMATION
These KaWe examination lights are subject to special safety measures with regard to EMC requirements and must be installed in accordance with
the enclosed EMC instructions. The functionality of these KaWe examination lights can be influenced by portable and mobile HF communication
devices.
The use of other accessories will result in increased emissions or decreased immunity of the unit.
For the KaWe examination light to operate as intended, it is necessary that the light not be placed directly next to or
stacked together with other equipment. If the lamp must be used directly next to or while stacked with other equipment,
the KaWe examination light is to be closely monitored.
Table 9.1 Guidelines and Manufacturer Declaration – Electromagnetic Emissions
Guidelines and Manufacturer Declaration – Electromagnetic Emissions
The KaWe examination lamp is designed to be used in the types of environments listed below.
The customer or user of the KaWe examination lamp is responsible for ensuring that this device is used in such an environment.
Emissions Measurement
Conformity
Harmonic oscillations according to IEC
Class A
61000-3-2
Voltage fluctuations / flicker emissions
Complies
according to IEC 61000-3-3
Type-CISPR 15-1
Complies
high frequency emissions
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7. CE-LABEL
This KaWe examination light complies with guidelines
93/42/EWG (guidelines for medical products from the council of the
European communities). The applicable standard is EN 60601-2-41.
The company KaWe GmbH + Co. KG is certified according to DIN EN
ISO 13485:2012 + AC:2012.
8. DISPOSAL
At the end of the product's life, the components of the KaWe
examination light are to be disposed of properly. Ensure that the mate-
rials are sorted carefully according to type. The electrical circuit boards
are to be disposed of at an appropriate recycling centre. The lamp
housing and the rest of the components of the KaWe examination light
should be disposed of according to their type of material.
Electromagnetic environment – guidelines
The KaWe examination lamp is designed for use in all facilities includ-
ing living spaces that are directly connected to a public low-voltage
power supply network that also supplies power to buildings used for
domestic purposes.
The KaWe examination lamp is not designed to be connected to any
other type of device.
Table 9.2
Guidelines and Manufacturer Declaration – Electromagnetic Interference Immunity
Guidelines and Manufacturer Declaration – Electromagnetic Interference Immunity
The KaWe examination lamp is designed to be used in the types of environments listed below.
The customer or user of the KaWe examination lamp is responsible for ensuring that this device is used in such an environment.
Interference
IEC 60601-
immunity test
test level
Electrostatic
± 6kV contact discharge
discharge (ESD)
according to
± 8 kV air discharge
IEC 61000-4-2
± 2kV for power supply lines
Fast transient electrical
disturbances/ bursts according
± 1kV for input and output
to IEC 61000-4-4
lines
± 1 kV differential mode
voltage
Surges according to
IEC 61000-4-5
± 2 kV common mode
voltage
< 5 % U
T
(>95 % dip in the U
)
T
for a ½ period
40 % U
T
Voltage dips, short inter-
(60 % dip in the U
)
T
ruptions
for 5 periods
and voltage variations
on power supply input lines
70 % U
T
according to IEC 61000-4-11
(30 % dip in the U
)
T
for 25 periods
< 5 % U
T
(>95 % dip in the U
)
T
for 5 seconds
Magnetic field with a power
frequency of (50/60 Hz)
3 A/m
according to IEC 61000-4-8
Note: U
is the mains voltage prior to application of the test level.
T
Compliance
Electromagnetic environment –
level
guidelines
The flooring should be wood or
± 6kV contact discharge
concrete or be covered with ceramic tile.
If the floor material is a non-conductive,
± 8 kV air discharge
synthetic material, the relative humidity
of the air must be at least 30%.
± 2kV for power supply lines
The quality of the mains supply voltage
should be the same as that of a typical
Not applicable
commercial or hospital environment.
± 1 kV differential mode
voltage
The quality of the mains supply voltage
should be the same as that of a typical
± 2 kV common mode
commercial or hospital environment.
voltage
< 5 % U
T
(>95 % dip in the U
)
T
for a ½ period
The quality of the mains supply voltage
40 % U
should be the same as that of a typical
T
(60 % dip in the U
)
commercial or hospital environment.
T
for 5 periods
If the user of the KaWe examination lamp
requires continued operation during
70 % U
power interruptions, it is recommended
T
(30 % dip in the U
)
that the KaWe examination lamp be
T
for 25 periods
powered from an uninterruptable power
supply or a battery.
< 5 % U
T
(>95 % dip in the U
)
T
for 5 seconds
Magnetic fields with their line
frequencies should be the same as those
30 A/m
typical of commercial and hospital
environments.
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