Instructions for Use
Spirostik Complete
Serial no.: xx|8|102|yyy and 2103xxxxx
Version: 7
| Release date: 14. July 2021
Page 39
4.1.4
System Construction and Electrical Safety
The Spirostik Complete can be operated with the included
medical power supply unit and due to the integrated computer
on which the BLUE CHERRY® application software is installed,
it is an independent medical electrical system (ME System).This
system can also be expanded due the possibility of connecting
approved peripherals. The following instructions are intended to
form such a system safely, taking into account the electrical
safety concept of the Spirostik Complete (see chap. 12.3
"Electrical Safety Concept").
Preferably, the system should be constructed by a specialist
retail partner but may also be carried out by the responsible
organisation of Spirostik Complete 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".
