Instructions for Use
Spirostik Complete
Serial no.: xx|8|102|yyy and 2103xxxxx
Page 80
Version: 7 | Release date: 14. July 2021
12.4.3
Interference Resistance for Non-Life-Supporting 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 -level
Compliance level
Electromagnetic enviroment -
Guidline
Portable and mobile RF
communication devices should not
be used at a shorter distance from
the Spirostik Complete as the
recommended safety distance
calculated according to the
equation applicable to the
transmission frequency.
Recommended safety
distance:
Conducted HF-
distrubance
variable
IEC 61000-4-6
3 V
Effective value
150 kHz to
80 MHz
𝑈𝑈
1
= 3 V
𝑑𝑑
=
�
3
.
5
𝑈𝑈
1
� √𝑃𝑃
Radiated HF-
distrubance
according to
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
𝐸𝐸
1
= 3 V/m
𝑑𝑑
=
�
3
.
5
𝐸𝐸
1
� √𝑃𝑃
from 80 MHz up to 800 MHz
𝑑𝑑
=
�
7
𝐸𝐸
1
� √𝑃𝑃
from 800 MHz up to 2.5 GHz
