Instructions for Use
Spirostik Blue
Serial no.: 2111xxxxx
Version: 7 | Release date: 02. August 2021
Page 39
4.1.5
System Construction and Electrical Safety
Spirostik Blue is operated with its own power supply
(accumulators) and, along with the computer where the
application software is installed, forms a medical electrical
system (ME system). The following instructions serve to allow the
safe construction of such a system, while taking into account the
Spirostik Blue electrical safety concepts.
The following instructions are intended for safe handling of the
entire system, taking into account the electrical safety concept of
the Spirostik Blue.
Preferably, the system should be constructed by a specialist
retail partner but may also be carried out by the responsible
organisation of Spirostik Blue themselves.
It is essential to note: Anyone who combines additional
devices or medical devices or unauthorised or non-original
components / spare parts / consumables with existing
medical, electrical equipment or systems, and this
combination is used by third parties or this combination is
placed on the market, will legally become a producer of a
system or a procedure pack. In any case the assembler of a
system is therefore responsible for compliance with the
requirements placed on the system by the relevant,
harmonised standards and the additional national and
international standards and guidelines in the currently valid
versions!
You will find a detailed description of the correct system
formation in:
•
The technical manual "Formation of Systems".
