Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Page 48
Version: 8 | Release date: 16. August 2021
4.1.4
System Construction and Electrical Safety
The following instructions are intended for safe handling of the
entire system, taking into account the electrical safety concept of
the Diffustik resp. the variant PFTstik.
The system may be set up only by an authorised specialist retail
partner.
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".
For the Diffustik variant resp. when the "CO Diffusion" option is
added to the PFTstik variant, the connection of the relevant
components is described in the separate IFU
Add-on CO Diffusion.
