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 8/38
ID010
Only use the plasma care® with the original components and accessories from
the manufacturer.
ID011
Do not perform any modifications on the plasma care® without permission of
the manufacturer.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
ID012
Do not open the plasma care® under any circumstances. There is danger of
high voltage!
ID013
Before starting-up the plasma care® after it has been transported, the medical
device needs to reach a temperature within the operating conditions (see
chapter 11.1 Operating conditions).
2.3.2 Treatment and operation
ID014
The treatment with the plasma care® may only be performed by instructed
healthcare professionals.
ID015
Only use the plasma care® for its intended medical purpose (see chapter 3)
taking into account its indications and contraindications (see chapter 3).
ID016
Always use the plasma care® in combination with a plasma care® spacer. Using
the plasma care® without a plasma care® spacer is not possible.
ID017
Use a plasma care® spacer for a single patient only. Otherwise cross-contami-
nation may occur.
ID018
Gently place the plasma care® spacer onto the patient’s skin to produce a
closed volume, if possible.
ID019
Prior to the treatment with the plasma care®, you need to remove all wound
dressings and bandages. Furthermore, the wound bed needs to be prepared for
example by debridement (see chapter 8).