Otto Bock 757L43, Instructions For Use Manual, Page: 123 / 127

Electromagnetic Environment
__________________________________________________________________________________________
EMC – Special requirements according medical standard
Intended use and
intended environment
Home healthcare and/or Professional environment
Basic safety and
essential performance of
the EUT
The DC/DC converter unit itself is not a medical end product, therefore no
essential performance is defined by the manufacturer.
Basic safety regarding
EMC
The DC/DC converter has to ensure proper output voltage according to its
characteristics, without service within expected service life.
WARNINGS
Medical electrical equipment needs special precautions regarding EMC and
needs to be installed according to EMC information.
User shall not modify DC/DC converter.
The DC/DC converter is designed to achieve the EMI behavior of the
specified environment, it includes specific EMI filter to reduce the emissions
which are specified in the IEC60601-1-2 standard.
Please read the complete technical documentation to avoid adverse events to
the patient and operator. Read also instructions for use.
EMC - Environment
The DC/DC converter is intended for use in the electromagnetic environment specified below. The
customer or the user of the DC/DC converter should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The DC/DC converter 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.
RF emissions
CISPR 11
Class B
The DC/DC converter is suitable for use in all establishments,
including domestic establishments. This DC/DC converter shall
be connected with an USB power supply. This USB power supply
can be connected directly to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
N/A
Immunity test
EN 60601-1-
2:2015
test level
Achieved levels
according EN 60601-1-
2:2015 and achieved
levels from additional
standards.
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV
contact
±2 kV,
± 4 kV,
± 8 kV,
± 15 kV
air
± 8 kV
contact
±2 kV,
± 4 kV,
± 8 kV,
± 15 kV
air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 610004-4
N/A
Surge
IEC 61000-4-5
N/A
Voltage dips, short
interruptions and
N/A