Instructions for Use
Ambistik PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 35
4.1.3
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 Ambistik PFT / Ambistik CPET.
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".
Independent of this, the following should also be observed:
Possible danger to life.
Reason: Electric shock. Misdiagnosis. Therefore:
•
Do not modify or use the Ambistik PFT /
Ambistik CPET or total system contrary to the
respective manufacturer's specification!
