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Guidelines and manufacture declaration – Electromagnetic emissions
The KaWe MASTERLIGHT HL / LED is designed to be used in the types of electromagnetic environments listed below.
The customer or user is responsible for ensuring that this device is used in such an environment.
Emissions Measurement
Conformity Electromagnetic environment – Guidelines
Type-CISPR 11 –
high-frequency emissions
Group 1
The KaWe MASTERLIGHT HL / LED uses high-frequency energy solely for its internal
OPERATION. Its high-frequency emissions are therefore very low and it is unlikely that
any nearby electronic equipment will be adversely effected.
Type-CISPR 11 –
high-frequency emissions
Class B
The KaWe MASTERLIGHT HL / LED is designed for use in all facilities including living
spaces that are directly connected to a public low-voltage power supply network that
also supplies power to buildings used for domestic purposes.
Harmonic oscillations according
to IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissi-
ons according to IEC 61000-3-3
Complies
10. TABLES
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.
Guidelines and Manufacturer Declaration – Electromagnetic Interference Immunity
The KaWe MASTERLIGHT HL / LED is designed to be used in the types of environments listed below.
The customer or user of the KaWe MASTERLIGHT HL / LED is responsible for ensuring that this device is used in such an environment.
Interference immunitytest IEC 60601-test level
Compliance level
Electromagnetic environment
– guidelines
Electrostatic
discharge (ESD)
according to
IEC 61000-4-2
± 6kV contact discharge
± 8 kV air discharge
± 6kV contact discharge
± 8 kV air discharge
The flooring should be wood
or concrete or be covered with
ceramic tile. If the floor material is a
non-conductive, synthetic material,
the relative humidity of the air must
be at least 30%.
Fast transient electrical
disturbances/ bursts according
to IEC 61000-4-4
± 2kV for power supply lines
± 1kV for input and
output lines
=> not applicable
± 2kV for power supply lines
± 1kV for input and
output lines
=> not applicable
The quality of the mains supply
voltage should be the same as that
of a typical commercial or hospital
environment.
Surges according to
IEC 61000-4-5
± 1 kV differential mode
voltage
± 2 kV common mode voltage
± 1 kV differential mode
voltage
± 2 kV common mode voltage
The quality of the mains supply
voltage should be the same as that
of a typical commercial or hospital
environment.
Voltage dips, short interrup-
tions and voltage variations
on power supply input lines
according to IEC 61000-4-11
< 5 % UT
(>95 % dip in the UT )
for a ½ period
40 % UT
(60 % dip in the UT )
for 5 periods
70 % UT
(30 % dip in the UT )
for 25 periods
< 5 % UT
(>95 % dip in the UT )
for 5 seconds
< 5 % UT
(>95 % dip in the UT )
for a ½ period
40 % UT
(60 % dip in the UT )
for 5 periods
70 % UT
(30 % dip in the UT )
for 25 periods
< 5 % UT
(>95 % dip in the UT )
for 5 seconds
The quality of the mains supply
voltage should be the same as that
of a typical commercial or hospital
environment.
If the user of the KaWe MASTER-
LIGHT HL / LED requires continued
operation during power interrup-
tions, it is recommended that the
KaWe MASTERLIGHT HL / LED be
powered from an uninterruptable
power supply or a battery.
Magnetic field with a power
frequency of (50/60 Hz) ac-
cording to IEC 61000-4-8
3 A/m
30 A/m
Magnetic fields with their line
frequencies should be the same as
those typical of commercial and
hospital environments.
Note:
Uτ is the mains voltage prior to application of the test level.
7. ELECTRICAL INSTALLATION INFORMATION
The KaWe MASTERLIGHT HL / LED lamp comes with a power adaptor.
Caution! The power adaptor is a protection class II unit.
7.1 Environmental conditions
Operation
MIn.
Max.
Temperature
+10° C
+40° C*
Relative humidity
30 %
75 %
Air pressure
700 hPa
1060 hPa
*for higher temperatures, please consult manufacturer
Transport/Storage
MIn.
Max.
Temperature
–10° C
+50° C
Relative humidity
30 %
75 %
Air pressure
700 hPa
1060 hPa
7.2 Instructions on the packaging
Temperature range
during transport and
storage
Humidity during
transport and
storage
RH
20% - 90%
Air pressure during
transport and
storage
P
700hPa - 1060hPa
–10° C
+50° C
7.3 Important information
If multiple lamps are used at once, the total irradiance 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 su-
perposition of the luminous fields of multiple lights may cause the
limit values for UV radiation (<400 nm) of 10 W/m² to be exceeded. If
other lights or appliances are connected together during installation,
section 16 of EN 60601-A1:2012 applies and if necessary, the compli-
ance with the requirements is to be verified. KaWe examination lamps
are subject to special safety measures with regard to electromagnetic
compatibility. The function of KaWe examination lamps can be influ-
enced by high-frequency communication devices. (Heed the following
tables.)
8. CE LABEL
KaWe MASTERLIGHT HL / LED products comply with the guide-
lines 93/42/EWG for medical products from the council of the Euro-
pean communities. The applicable standard is EN 60601-2-41. The
company KaWe is certified according to EN ISO 13485:2012 + AC:2012.
9. DISPOSAL
At the end of its product life, the lamp’s components are to be
disposed of properly. Ensure that the materials are sorted carefully ac-
cording to type. The electrical circuit boards are to be disposed of at an
appropriate recycling centre. The lamp’s housing and the rest of the
components should be disposed of according to their type of material.
Содержание MASTERLIGHT HL/LED
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