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 13/38
3 Intended Use, Indications for Use, Side Effects, Compli-
cations, and Contraindications
The plasma care® is a medical device for the painless antimicrobial treatment of wounds with
cold atmospheric plasma. It is used with an add-on, the plasma care® spacer,i a sterile single-
use spacer. It requires minimal contact with the patient’s wound or intact skin and is operated
by healthcare professionals.
3.1 Intended use
The aim is to reduce the bacterial and fungal infiltration of a skin wound with the plasma care®.
For this purpose the operator (e.g. a nurse) places the plasma care® with the spacer attached
gently onto the wound, starts plasma generation and keeps the medical device in position until
the treatment is completed (a detailed description can be found in chapter 8).
The bacterial and fungal burden in the wound is reduced through the contact of the gener-
ated plasma species with the microorganisms. Eukaryotic (human) tissue is not damaged.
3.2 plasma care® is adjunctive therapy
The plasma care® can be used as an add-on to regular wound therapy, (i.e. in addition to the
usual community standard treatment methods). Standard procedures using cleaning solutions
/ debridement, topically applied medications or antiseptics, and wound dressings should be
continued.
In general, wound bed preparation using any form of debridement and wound irrigation or
similar water-based solutions should be performed prior to the plasma treatment.However, the
plasma treatment should be carried out prior to the application of any other medications that
remain in the wound.
The full effect of the plasma treatment can only be achieved, if the plasma species come into
direct contact with the bacteria and fungi in the wound.
3.3 Indications for Use
The plasma care® device decreases the microbial flora of skin wounds. The plasma care®
device is an adjunct to standard therapies including wound debridement and topical antimi-
crobial solutions.
The plasma care® device has been shown in vitro to reduce the following bacteria by
greater than 5 log: Staphylococcus aureus, Staphylococcus epidermidis, methicillin resistant
Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, Escherichia coli, Enterococcus
faecalis, Streptococcus agalactiae, Streptococcus constellatus, and Corynebacterium pro-
pinquum.
The plasma care® device has been shown in vitro to reduce Candida albicans by greater
than 4.6 log.
3.4 Side effects / Contraindications
There are no known side effects or complications associated with a treatment using the
plasma care® device.
A treatment with plasma care® is contraindicatd for: