Directives And Manufacturer's Declaration; Electromagnetic Environment - Otto Bock 17KO1 Series Instructions For Use Manual

Appendices

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 15).
The following tables outline the test levels of the tests to be carried out. The higher value applies if there is a differ­
ence between the operating environments listed in the tables below.
Table 1 – Electromagnetic emissions for all devices and systems
Interference measurements
HF emissions according to CIS­
PR 11
HF emissions according to CIS­
PR 11
Harmonics according
IEC 61000-3-2
Voltage fluctuations/flicker accord­
ing to IEC 61000-3-3
Table 4 - casing
Phenomenon
Electrostatic discharge
High frequency electro­
magnetic fields
High frequency electro­
magnetic fields in
immediate vicinity of wire­
less communication
devices
Magnetic fields with rated
power frequencies
Table 5 - alternate current gate for the supply input
Phenomenon
Electrical fast transi­
ents/bursts
Surges
Line against line
56
Compliance
Group 1
Class B
to N/A
N/A
EMC basic standard or
test procedure
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
the
IEC 61000-4-8
EMC basic standard or
test procedure
IEC 61000-4-4
IEC 61000-4-5
Electromagnetic environment dir­
ective
The product uses HF energy exclus­
ively for its internal functioning. Its
HF emissions are therefore very low,
and interference with neighbouring
electronic devices is unlikely.
The product is intended for use in
other than residential facilities and in
facilities connected directly to a pub­
lic low-voltage network that also sup­
plies residential buildings.
Interference immunity test level
Professional healthcare
facility
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air,
3 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
See Table 9
30 A/m
50 Hz or 60 Hz
Interference immunity test level
Professional healthcare
facility
± 2 kV
100 kHz repetition rate
± 0.5 kV, ± 1 kV
Environments in areas of
home healthcare
10 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
Environments in areas of
home healthcare
C-Brace joint unit 17KO1=*