Directives And Manufacturer's Declaration; Electromagnetic Environment - Otto Bock X2 Series Instructions For Use Manual

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
HF emissions according to
CISPR 11
HF emissions according to
CISPR 11
Harmonics according to
IEC 61000-3-2
Voltage fluctuations/flicker
according to IEC 61000-3-3
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
Electrostatic dis­
charge (ESD) accord­
ing to IEC 61000-4-2
104
Compliance
Group 1
Class B
N/A
N/A
IEC 60601 test level
± 6 kV discharge on
contact
± 8 kV discharge
through air
Electromagnetic environ­
ment directive
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.
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.
Compliance level
± 6 kV discharge on
contact
± 8 kV discharge
through air
Electromagnetic
environment direct­
ive
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 %.