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17.3 Directives and manufacturer’s declaration
17.3.1 Electromagnetic environment
This product is designed for operation in the following electromagnetic environments:
•
Operation in a professional healthcare facility (e.g. hospital, etc.)
•
Operation in areas of home healthcare (e.g. use at home, use outdoors)
The customer or user of the product must ensure that it is operated in such an environment.
Observe the safety notices in the section "Information on proximity to certain areas" (see
Page 68).
The following tables outline the test levels of the tests to be carried out. The higher value applies if
there is a difference between the operating environments listed in the tables below.
Table 1 – Electromagnetic emissions for all devices and systems
Directives and manufacturer's declaration – electromagnetic interference
The product 'X2 Bionic Prosthetic System 3B5-X2' is designed for operation in an electromag
netic environment as specified below. The customer or user of the product 'X2 Bionic Prosthetic
System 3B5-X2' must ensure that the device is operated in such an environment.
Interference measurements
Compliance
Electromagnetic environ
ment directive
HF emissions according to
CISPR 11
Group 1
The product 'X2 Bionic Pros
thetic System 3B5-X2' uses
HF energy exclusively for its
internal functioning. Therefore
its HF emissions are very low
and interference with neigh
bouring electronic devices is
unlikely.
HF emissions according to
CISPR 11
Class B
Harmonics according to
IEC 61000-3-2
N/A
Voltage fluctuations/flicker
according to IEC 61000-3-3
N/A
The product 'X2 Bionic Pros
thetic System 3B5-X2' is inten
ded for use in other than resid
ential facilities and in facilities
connected directly to a public
low-voltage network that also
supplies residential buildings.
Table 2 – Electromagnetic interference immunity for all devices and systems
Directives and manufacturer's declaration – electromagnetic interference immunity
The product 'X2 Bionic Prosthetic System 3B5-X2' is designed for operation in an electromag
netic environment as specified below. The customer or user of the product 'X2 Bionic Prosthetic
System 3B5-X2' must ensure that the device is operated in such an environment.
Interference
immunity test
IEC 60601 test level
Compliance level
Electromagnetic
environment direct
ive
Electrostatic dis
charge (ESD) accord
ing to IEC 61000-4-2
± 6 kV discharge on
contact
± 8 kV discharge
through air
± 6 kV discharge on
contact
± 8 kV discharge
through air
Floors should be
wood, concrete or
ceramic tile. If the
floor covering is made
of synthetic material,
the relative humidity
must be at least 30 %.
