User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 12
2.3
Security
2.3.1
General Security information
This manual is intended for medical technical personnel, familiar with
the performance of CO-Diffusion testing procedures. Users have to be
familiar with the testing method and its clinical acceptation. The
instructions within this document are intended to describe the
operation of the software and the handling of the equipment and
should not be considered as training for the medical or technical
personnel.
Before using the equipment users should read and understand this
included user manual, paying attention to the operating instructions.
Geratherm Respiratory is responsible for the security and reliability of
function of the Diffustik, as such only authorized personnel should
perform changes or repairs to the system. Please consult your
Geratherm Respiratory specialist service centre for any repairs. This
equipment meets the requirements of VDE 0100
Geratherm Respiratory will not accept any warranty claims caused by
the use of alternative accessories or consumables. Always use official
Geratherm Respiratory products.
2.3.1.1
Norms and Guidelines
The Geratherm Respiratory products are manufactured in accordance
with DIN EN ISO 13485. According to the European directive 93/42/EEC,
Bodystik fulfils the requirements of annex II.
