Stryker Flosteady Arthroscopy Pump 200, Manual

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Guidelines and manufacturer's statement - electromagnetic compatibility
41
EN
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.
*Note: U
T
is the mains alternating voltage before applying the test levels.
Electromagnetic
interference
immunity tests
Test level Compliance Electromagnetic envi-
ronment guidelines
Discharge of static
electricity (ESD)
according to
IEC 61000-4-2
± 6 kV contact
discharge
± 8 kV air dis-
charge
In compli-
ance
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%.
Electrical fast
transients / bursts
according to
IEC 61000-4-4
± 2 kV for AC
power lines
± 1 kV for input
and output lines
In compli-
ance
The quality of the sup-
ply voltage should be
the same as the voltage
of a typical business or
hospital environment.
Surges according
to IEC 61000-4-5
± 1 kV normal
mode voltage,
± 2 kV common
mode voltage
In compli-
ance
The quality of the sup-
ply voltage should be
the same as the voltage
of a typical business or
hospital environment.
Blackouts, brown-
outs, and fluctua-
tions of the power
supply according
to IEC 61000-4-11
< 5% U
T
* (> 95%
dip in the U
T
) for
½ cycle
In compli-
ance
The quality of the sup-
ply voltage should be
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
device with power from
an uninterruptible
power supply.
40% U
T
(60% dip
in the U
T
) for 5
cycles.
70% U
T
(30% dip
in the U
T
) for 25
cycles.
< 5% U
T
(> 95%
dip in the U
T
)for
5 s
Supply frequency
magnetic field
(50/60 Hz) accord-
ing to IEC 61000-
4-8
3 A/m In compli-
ance
Magnetic fields of the
mains power fre-
quency should comply
with the typical values
of business and hospi-
tal environments.