Guidelines And Manufacturer's Statement - Electromagnetic Interference Immunity - Arthrex Synergy Insufflation FM134 Instructions D'utilisation

12.4 Guidelines and Manufacturer's Statement - Electromagnetic In-
terference Immunity
The insufflator is intended for use in an electromagnetic environment as de-
scribed below. The user/operator of the insufflator should make sure the device
is operated within such an environment.
Electromagnetic Test level
interference immu-
nity tests
Discharge of static ± 6 kV contact
electricity (ESD) discharge
according to ± 8 kV air dis-
IEC 61000-4-2 charge
Electrical fast tran- ± 2 kV for
sients / bursts power lines,
according to ± 1 kV for
IEC 61000-4-4 input and out-
put lines
Surges according to ± 1 kV normal
IEC 61000-4-5 mode voltage,
± 2 kV com-
mon mode
voltage
Blackouts, brown- < 5% U
T
outs, and fluctua- 95% dip in the
tions of the power U ) for ½ cycle
T
supply according to
40% U
IEC 61000-4-11
T
dip in the U
for 5 cycles.
70% U
T
dip in the U
for 25 cycles.
< 5% U
T
95% dip in the
U ) for 5 s
T
Supply frequency 3 A/m
magnetic field (50/
60 Hz) according to
IEC 61000-4-8
*Note: U is the mains alternating voltage before applying the test levels.
T
Compliance Electromagnetic envi-
ronment guidelines
In compliance Floors should be made
from wood or concrete
or covered with ceramic
tiles. If the floor cover-
ing consists of synthetic
material, the relative
humidity should be at
least 30%.
In compliance The quality of the sup-
ply voltage should be
the same as the voltage
of a typical business or
hospital environment.
In compliance The quality of the sup-
ply voltage should be
the same as the voltage
of a typical business or
hospital environment.
* (> In compliance The quality of the sup-
ply voltage should be
the same as the voltage
of a typical business or
(60%
hospital environment.
)
If the user/operator of
T
device requires the con-
tinuation of functional-
(30%
ity after power
)
T
interruptions/disrup-
tions, it is recom-
(> mended to provide the
device with power from
an uninterruptible
power supply.
In compliance Magnetic fields of the
mains power fre-
quency should comply
with the typical values
of business and hospi-
tal environments.
Electromagnetic Compatibility
55
EN