Instructions for Use
Spirostik Complete
Serial no.: xx|8|102|yyy and 2103xxxxx
Version: 7
| Release date: 14. July 2021
Page 79
12.4.2
Interference Resistance for all ME Systems Guideline and
Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity
The Spirostik Complete is determined for operation in an electromagnetic environment as
specified below. The user / operator of the Spirostik Complete should ensure that it is operated
in this environment.
Measurement of
interference immunity
IEC 60601 – test
level
Compliance level
Electromagnetic
environment – Guideline
Electrostatic
discharge (ESD)
according to
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be made of
wood, concrete or ceramic
tiles. If the floor is covered
with synthetic material, the
relative humidity must be at
least 30 %.
Fast transient
electrical
disturbances, bursts
according to
IEC 61000-4-4
±2 kV for power
cables
±1 kV for input and
output lines
±2 kV for power
cables
±1 kV for input and
output lines
The quality of the supply
voltage should be
appropriate for a typical
business- or hospital
environment
Surges
according to
IEC 61000-4-5
±1 kV Voltage outer
conductor - outer
conductor
±2 kV Voltage outer
conductor end
±1 kV Voltage outer
conductor - outer
conductor
±2 kV Voltage outer
conductor end
The quality of the supply
voltage should be
appropriate for a typical
business or hospital
environment
Voltage dips, short
interruptions and
supply voltage
fluctuations according
to IEC 61000-4-11
< 5 %
U
T
(> 95 % collapse of
the
U
T
)
for ½ Period
40 %
U
T
(60 % collapse of
the
U
T
)
for 5 Period
70%
U
T
(30 % collapse of
the
U
T
)
for 25 Period
5 %
U
T
(> 95 % collapse of
the
U
T
)
for 5 s
< 5 %
U
T
(> 95 % collapse of
the
U
T
)
for ½ Period
40 %
U
T
(60 % collapse of
the
U
T
)
for 5 Period
70%
U
T
(30 % collapse of
the
U
T
)
for 25 Period
5 %
U
T
(> 95 % collapse of
the
U
T
)
for 5 s
The quality of the supply
voltage should be
appropriate for a typical
business or hospital
environment.
If the user of the Spirostik
Complete system requires
continued operation even
during power interruptions,
it is recommended that the
Spirostik Complete be
powered from an
uninterruptible power
supply or a battery.
Magnetic field at the
supply frequency
(50 / 60 Hz)
to IEC 61000-4-8
3 A/m
3 A/m
Magnetic fields at the mains
frequency should
correspond to the typical
values as found in the
business and hospital
environment.
