Guidelines And Manufacturer's Statement - Electromagnetic Interference Immunity - Stryker Flosteady Manual Del Usuario

14.5 Guidelines and Manufacturer's Statement - Electromagnetic In-
terference Immunity
The device FLOSTEADY Arthroscopy Pump is intended for use in an electromag-
netic environment as described below. The user/operator of the FLOSTEADY Ar-
throscopy Pump should make sure the device is operated within such an
environment.
Electromagnetic Test level
interference
immunity tests
Discharge of static ± 6 kV contact
electricity (ESD) discharge
according to ± 8 kV air dis-
IEC 61000-4-2 charge
Electrical fast ± 2 kV for AC
transients / bursts power lines
according to ± 1 kV for input
IEC 61000-4-4 and output lines
Surges according ± 1 kV normal
to IEC 61000-4-5 mode voltage,
± 2 kV common
mode voltage
Blackouts, brown- < 5% U * (> 95%
T
outs, and fluctua- dip in the U
tions of the power ½ cycle
supply according
40% U (60% dip
to IEC 61000-4-11
T
in the U ) for 5
T
cycles.
70% U (30% dip
T
in the U ) for 25
T
cycles.
< 5% U (> 95%
T
dip in the U
5 s
Supply frequency 3 A/m
magnetic field
(50/60 Hz) accord-
ing to IEC 61000-
4-8
*Note: U is the mains alternating voltage before applying the test levels.
T
Guidelines and manufacturer's statement - electromagnetic compatibility
Compliance Electromagnetic envi-
ronment guidelines
In compli- Floors should be made
ance 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 compli- The quality of the sup-
ance ply voltage should be
the same as the voltage
of a typical business or
hospital environment.
In compli- The quality of the sup-
ance ply voltage should be
the same as the voltage
of a typical business or
hospital environment.
In compli- The quality of the sup-
) for ance ply voltage should be
T
the same as the voltage
of a typical business or
hospital environment.
If the user/operator of
device requires the con-
tinuation of functional-
ity after power
interruptions/disrup-
tions, it is recom-
mended to supply the
)for device with power from
T
an uninterruptible
power supply.
In compli- Magnetic fields of the
ance mains power fre-
quency should comply
with the typical values
of business and hospi-
tal environments.
EN
41