Stryker FLUID SAFE - Guidelines and Manufacturers Statement - Electromagnetic Emissions; Guidelines and Manufacturers Statement - Electromagnetic Interference Immunity

Initial Use of the Device
11
EN
4.3 Guidelines and Manufacturer's Statement - Electromagnetic Emissions
The FLUID SAFE Fluid Management System is intended for use in an environment as described below. The user/operator of the
FLUID SAFE Fluid Management System should make sure the device is operated within such an environment.
4.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity
The FLUID SAFE Fluid Management System is intended for use in the electromagnetic environment specified below. The
user/operator of the FLUID SAFE Fluid Management System should make sure the device is operated within such an environment.
*Note: UT is the mains alternating voltage before applying the test levels.
Emitted interference
measurements
Compliance Electromagnetic environment guidelines
HF emission according to
CISPR 11
Group 1 The device FLUID SAFE Fluid Management System uses high
frequency energy only for its internal functions. Therefore,
its HF emission is very low and it is unlikely that devices in
close proximity will experience any interference.
HF emission according to
CISPR 11
Class B The FLUID SAFE Fluid Management System is suitable for
use in all facilities including those in residential areas and
those directly connected to a public utility network also
supplying buildings used for residential purposes.
Emission of harmonic oscillations
according to IEC 61000-3-2
Class A
Emission of voltage fluctuations /
flickers according to
IEC 61000-3-3
In compliance
Electromagnetic interference
immunity tests
IEC 60601 test level Compliance Electromagnetic environment
guidelines
Discharge of static electricity
(ESD) according to
IEC 61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
In compliance Floors should be made of wood or
concrete or feature ceramic tiles. If
the floor covering consists of
synthetic material, the rel. humidity
should be at least 30%.
Fast electrical transients /
bursts according to
IEC 61000-4-4
± 2 kV for AC power lines
± 1 kV for input and output
lines
In compliance The quality of the supply voltage
should be the same as the voltage of
a typical business or hospital
environment.
Surges according to
IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode voltage
In compliance The quality of the supply voltage
should be the same as the voltage of
a typical business or hospital
environment.
Blackouts, brownouts, and
fluctuations of the power
supply according to
IEC 61000-4-11
< 5% U
T
*
(>95% dip in U
T
) for
½ cycle
40% U
T
(60% crash of the U
T
)
for 5 periods
70% U
T
(30% crash of the U
T
)
for 25 periods
<5% U
T
(>95% dip in U
T
)
for 5 s
In compliance The quality of the supply voltage
should be the same as the voltage of
a typical business or hospital
environment. If the user/operator of
the FLUID SAFE Fluid Management
System requires the continuation of
functionality after power
interruptions/disruptions, it is
recommended to provide the FLUID
SAFE Fluid Management System with
power from an uninterruptible
power supply.
Supply frequency magnetic
field (50/60 Hz) acc. to
IEC 61000-4-8
3 A/m In compliance Magnetic fields of the mains power
frequency should comply with the
typical values of business and
hospital environments.