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 9/38
ID020
If non-vital tissue, necrotic tissue, fibrin layers or foreign particles are present in
the wound, careful wound bed preparation (using wound rinsing solutions with-
out active components) needs to be performed prior to plasma care® treat-
ment. Otherwise the plasma treatment may not be effective.
ID021
Wound rinsing solutions with active components may not be used immediately
prior to the treatment with plasma care®. When plasma care® treatment is to
be performed, wound bed preparation with a wound rinsing solution free of ac-
tive components needs to be carried out right beforehand.
ID022
The treatment of the wound of a patient with the plasma care® may only be
performed once within a 12-hour window. The same section of a wound may
only be treated for a maximum duration of 3 minutes.
ID022b
The treatment can be interrupted at any time by exerting extended pressure on
the on / off button. Removal of the plasma care® spacer also leads to immedi-
ate interruption of the treatment.
If the treatment cannot be stopped by either of these two methods, the energy
supply of the plasma source can be interrupted by removing the plasma source
unit.
ID023
The plasma care® can cause electronic disturbances during its normal opera-
tion for its intended purpose, which may interfere with the function of other elec-
tronic devices.
ID024
Other electronic devices, especially high frequency devices such as mobile
phones can impact electronic medical devices. The use of plasma care® in di-
rect vicinity of such devices can therefore lead to an increased emission of or a
strongly reduced immunity of the plasma care® against disturbances.
ID024a
The plasma care ® should not be used in direct proximity to other devices or
combined with other devices as this can result in malfunction. In case the use of
the device in a setting as just described cannot be avoided special attention
has to be paid to the plasma care® as well as to all other devices to ensure
proper functioning.
ID025
Do not remove the plasma care® spacer or the plasma source unit under any
circumstances during treatment.
ID026
The plasma care® spacer protects the user and the patient from an unintended
contact with the plasma source through the integrated protection mesh.