Directives And Manufacturer's Declaration; Electromagnetic Environment - Ottobock Myo Plus Instrucciones De Uso

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12.3 Directives and manufacturer's declaration

12.3.1 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" (Information
on Proximity to Certain Areas).
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 4 - casing
Phenomenon
Electrostatic dis­
charge
High frequency elec­
tromagnetic fields
High frequency elec­
tromagnetic fields in
the immediate vicinity
of wireless communic­
ation devices
Magnetic fields with
rated power frequen­
cies
Table 5 - alternate current gate for the supply input
Phenomenon
Electrical fast transi­
ents/bursts
Surges
Line against line
Surges
Line against ground
Conducted interfer­
ence induced by high
frequency fields
36
EMC basic standard
or
test procedure
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
EMC basic standard
or
test procedure
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-5
IEC 61000-4-6
Interference immunity test level
Professional health­
care 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 health­
care facility
± 2 kV
100 kHz repetition rate
± 0.5 kV, ± 1 kV
± 0.5 kV, ± 1 kV, ± 2 kV
3 V/
0.15 MHz to 80 MHz
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
3 V/
0.15 MHz to 80 MHz