Guidelines And Manufacturer's Statement - Electromagnetic Emissions; Guidelines And Manufacturer's Statement - Electromagnetic Interference Immunity - Stryker FLUID SAFE Handbuch

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.
Emitted interference
measurements
HF emission according to
CISPR 11
HF emission according to
CISPR 11
Emission of harmonic oscillations
according to IEC 61000-3-2
Emission of voltage fluctuations /
flickers according to
IEC 61000-3-3
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.
Electromagnetic interference
immunity tests
Discharge of static electricity
(ESD) according to
IEC 61000-4-2
Fast electrical transients /
bursts according to
IEC 61000-4-4
Surges according to
IEC 61000-4-5
Blackouts, brownouts, and
fluctuations of the power
supply according to
IEC 61000-4-11
Supply frequency magnetic
field (50/60 Hz) acc. to
IEC 61000-4-8
*Note: UT is the mains alternating voltage before applying the test levels.
Compliance
Group 1
Class B
Class A
In compliance
IEC 60601 test level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for AC power lines
± 1 kV for input and output
lines
± 1 kV differential mode
± 2 kV common mode voltage
*
< 5% U (>95% dip in U ) for
T T
½ cycle
40% U (60% crash of the U )
T T
for 5 periods
70% U (30% crash of the U )
T T
for 25 periods
<5% U (>95% dip in U )
T T
for 5 s
3 A/m
Electromagnetic environment guidelines
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.
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.
Compliance Electromagnetic environment
guidelines
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%.
In compliance The quality of the supply voltage
should be the same as the voltage of
a typical business or hospital
environment.
In compliance The quality of the supply voltage
should be the same as the voltage of
a typical business or hospital
environment.
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.
In compliance Magnetic fields of the mains power
frequency should comply with the
typical values of business and
hospital environments.
Initial Use of the Device
11
EN