Standards Conformity - Luvion Intrelief Pfe Bedienungsanleitung

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Table 4: Declaration of Electromagnetic Immunity
All models are intended for use in the electromagnetic environment speci ed below. The customer
or the user of all models should assure that they are used in such an environment.
Immunity Test IEC 60601 Test Level
3 Vrms
150 kHz to 80 MHz
Conducted RF
6 Vrms in ISM bands and
IEC 61000 4 6
amateur radio bands
(Only apply to patient
coupling port)
0 V/m
80 MHz to 2.7 GHz
385 MHz-5785 MHz
Test speci cations for
Radiated RF
ENCLOSURE PORT
IEC 61000 4 3
IMMUNITY to RF
wireless communication
equipment (Refer to
table 9 of IEC 60601-1-
2:2014+A1:2020)

STANDARDS CONFORMITY

The device is tested and complies with the international standards listed below:
Standard Number
EN/IEC 60601-1
EN/IEC 60601-1-2
EN/IEC 60601-1-11
Guidance & Declaration – electromagnetic immunity
Standard Title
Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests
Medical electrical equipment – Part 1-11: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for
medical electrical equipment and medical electrical systems used in the
home healthcare environment
Compliance Level
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM bands and
amateur radio bands
(Only apply to patient
coupling port)
10 V/m
80 MHz to 2.7 GHz
385 MHz-5785 MHz
Test speci cations for
ENCLOSURE PORT
IMMUNITY to RF
wireless communication
equipment (Refer to
table 9 of IEC 60601-1-
2:2014+A1:2020)
Electromagnetic
environment – guidance
Portable RF
communications
equipment (including
peripherals such as
antenna cables and
external antennas)
should be used no
closer than 30 cm (12
inches) to any part of
all models, including
cables speci ed by
the manufacturer.
Otherwise, degradation
of the performance of
this equipment could
result.