32
Operating Instructions TNI
®
20s oxy Version 2.7
Version 1.6.3 July 2010
6 Hygiene
6 Hygiene
6.1 Disassembly for preparation
- Before dismantling the unit, switch off the
master switch at the back of the humidi-
fier unit and disconnect the mains cable!
Otherwise there is a real danger of electric
shock.
- Check that there is no water in the water
reservoir.
WARNING!
6.2 Preparation work
Preparation here means cleaning, disinfection and sterilization.
The humidifier unit of the TNI
®
device is classified as non-critical,
since it has no direct contact to the patient’s skin, merely indirect
contact to the patient over the warmed and humidified respiratory
air
1
. It is prescribed that the unit undergo preparation by means
of a thorough cleaning and an intermediate level disinfection
procedure.
Since it has contact to the mucous membranes, the applicator is
considered a single patient use component and classified as semi-
critical. It is cleaned and disinfected at regular intervals and used for
a maximum of 30 days. The applicator is not permitted to undergo
preparation for a new patient!
The objective of these instructions is to describe the cleaning and
disinfection procedures which on the one hand should be carried out
at regular intervals when the product is used by one patient, and on
the other hand what must be done to properly prepare the device
for use by another patient.
6.2.1 Required disinfectants and devices
Due to material compatibilities of the existing combinations of plastic
and stainless steel in the device, only use disinfectants based
1
Labeling reusable medical devices for reprocessing in health care facilities:
FDA Reviewer Guidance (Appendix 1 „Reprocessing Triage“), Office of Device
Evaluation, April 1996
