Use Instructions

Instruction for Use
plasma care and plasma care spacer
IFU plasma care© and plasma care© spacer
Version: 0.1
Date: 26.05.2020
Copyright: terraplasma medical GmbH
Page 10/38
ID027
Throughout treatment with the plasma care® ozone is generated at a low con-
centration. During the intended use of the plasma care® the legal limits for
ozone are not exceeded; however, the ozone can be detected by its scent.
The ozone is sufficiently diluted by the surrounding air. If the device is used in small
rooms and/or if several plasma care® devices are used in the same room and/or
upon extended treatment periods, a sufficient level of ventilation must be
achieved (for example by opening windows or doors).
The individual sensitivity towards ozone varies widely.
If the plasma care® is used in the presence of people with a chronic respiratory
disease/disorder or in the presence of infants and young children, special care
needs to be taken regarding sufficient ventilation, as these groups of people are
particularly sensitive.
ID028
Upon treatment with the plasma care® ozone is generated at low concentra-
tions. Treatments in the area of the head and particularly of the mouth should
be avoided.
ID028b
Upon treatment with the plasma care® UV radiation is generated at very low
intensity. Avoid treatments around the eyes.
ID029
The application of antiseptics, topical antibiotics, etc. should occur after the
treatment with the plasma care®. Otherwise no statement regarding the effec-
tiveness of the plasma treatment and/or the antimicrobial treatment can be
made.
2.3.3 Cleaning, maintenance and servicing
Clean the plasma care® after each treatment of a patient as described in
chapter 9 to prevent cross-contamination.
You may only use deteregents for cleaning of the plasma car that are de-
scribed in chapter 9.
Perform the cleaning procedure for the plasma care® using wipe disinfection as
described in chapter 9. Avoid excessive cleaning fluids, for example frequent
use of spray disinfectant, because the electronic components can be dam-
aged. Cleaning by submersion in a solution is prohibited.
Do not use pointed objects to clean the plasma source. It can be damaged as
a result, which may lead to faulty plasma generation and danger due to high
voltage. Perform the cleaning procedure as described in chapter 9.