PROTEOR SYNSYS Notice D'utilisation page 43

D.
Generalities
RF portable communication devices (including peripherals such as antenna cables and
external antennas) should not be used closer than 30 cm (12 inches) from any part of SYNSYS,
including the charger cable. Otherwise, SYNSYS' performance could be affected. Risk of
interference causing altered prosthesis behavior (e.g.: knee resistance), which could lead to a
fall. The prosthesis may also disrupt the operation of other nearby electronic devices.
This device should not be used next to other devices or stacked on them, because this
might cause a malfunction. If this use is required, check that this device and others are working
properly.
Using accessories, transducers, or cables others than those specified or supplied by the
manufacturer of this device may increase the electromagnetic emissions from this device, or
reduce its immunity, and lead to improper operation.
List of cables and accessories: charger 1P700234-S (manufacturer: PROTEOR) 155 cm.
Emissions
The medical device is designed for use in an electromagnetic environment as described in the
table below. So the user and certified prosthetist must make sure that the medical device is
used in the environment described below.
Emissions test
Electromagnetic radiation disturbance (radiated
emissions) (CISPR 11)
Disturbance voltage on the supply terminals
(Conducted emissions) (CISPR 11)
Harmonic current emissions (IEC61000-3-2)
Voltage changes, voltage fluctuations and flicker
(IEC61000-3-3)
Immunity
This medical device is designed for use in a home health care environment, and the
environment of a professional healthcare establishment. The user and certified prosthetist
must ensure the electromagnetic compliance of the environment.
Electro-magnetic compatibility
Environment for use: SYNSYS is designed for use at home and places
open to the general public. Do not stand near powerful magnetic or
electrical sources (high-voltage lines, transmitters, transformers,
MRIs, scanners, metal detectors, welding stations), ATEX zones
(=explosive atmospheres, oxygen-rich) or inflammable anesthetic
mixtures. The device is incompatible with defibrillation shocks.
Compliance
Group 1
Compliant
Electromagnetic environment – notes
This medical device uses RF energy for its internal /
external operation.
Class B
Home health care environment, and environment
Class A
of a professional healthcare establishment.
EN - 18