Directives And Manufacturer's Declaration; Electromagnetic Environment - Ottobock 757M20 Serie Instrucciones De Uso

Event
Unexpected display of the
recognised movement in
case of unfavourable resid­
ual limb conditions

13.4 Directives and manufacturer's declaration

13.4.1 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 1 – Electromagnetic emissions for all devices and systems
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 4 - casing
Phenomenon
Electrostatic dis­
charge
High frequency elec­
tromagnetic fields
28
Cause
No contact between
the electrodes and
skin
Myo gaiter slipping out
of place
Compliance
Group 1
Class B
N/A
N/A
EMC basic standard
or
test procedure
IEC 61000-4-2
IEC 61000-4-3
Required action
• The Myo gaiter has to fully contact the
residual limb
Electromagnetic environ­
ment directive
The product uses HF energy
exclusively for its internal func­
tioning. Its HF emissions are
therefore very low, and inter­
ference with neighbouring
electronic devices is unlikely.
The product is intended for
use in other than residential
facilities and in facilities con­
nected directly to a public low-
voltage network that also sup­
plies residential buildings.
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
Environments in
areas of home
healthcare
10 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz