Electromagnetic compatibility
Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CE-
MDR
15
8 Electromagnetic compatibility
8.1 General notes on the operating environment
The product is suitable for use in professional healthcare settings. Professional healthcare
facilities include physician offices, dental offices, limited care facilities, freestanding surgical
centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms,
patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system
for MRT).
The emission characteristics of this product make it suitable for use in professional
healthcare facilities as well as in a residential environment (CISPR 11 Class B). This
product offers adequate protection to radio communication service. In the rare event of
interference to the radio transmission operation, the user might need to take mitigation
measures, such as relocating or re-orienting the product.
8.2 Table 1 – Compliance level for immunity tests
Guidelines and manufacturer’s declaration – Electromagnetic immunity
The product is intended for use in the electromagnetic environment specified below. The user
of the product should make sure that it is used in such an environment.
Interference im-
munity tests
EN/IEC 60601 test
level
Compliance level
Electromagnetic envi-
ronment – Guidelines
Electrostatic dis-
charge (ESD) acc.
to IEC 61000-4-2
± 8 kV contact dis-
charge
± 15 kV air discharge
± 8 kV contact dis-
charge
± 15 kV air discharge
Floors should be made
of wood or concrete, or
covered with ceramic
tiles. If floors are cov-
ered with synthetic ma-
terial, the relative hu-
midity should be at
least 30%.
Electrical fast
transients/bursts
acc. to IEC
61000-4-4
± 2 kV for power lines
± 1 kV for input and
output lines
100 kHz repetition
N/A
The power supply qual-
ity should be that of a
typical commercial or
hospital environment.
Surges acc. to
IEC 61000-4-5
± 1 kV voltage outer
conductor – outer con-
ductor
± 2 kV voltage outer
conductor – ground
N/A
The power supply qual-
ity should be that of a
typical commercial or
hospital environment.
Voltage dips,
short interrup-
tions, and voltage
variations acc. to
IEC 61000-4-11
Voltage dip:
Dip to 0% for 1 cycle
at 0° phase angle
Dip to 70% for
25/30 cycles at 0°
phase angle
Dip to 0% for 0.5 cy-
cles @ 0°, 45°, 90°,
135°, 180°, 225°, 270°,
and 315° phase angles
Voltage interruption:
N/A
The power supply qual-
ity should be that of a
typical commercial or
hospital environment. If
the user of the product
requires continued op-
eration in the event of
interruptions to the
power supply network,
it is recommended that
the product be oper-
