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 2/38
Table of contents
1 Imprint .............................................................................................................................................. 4
1.1 Imprint ..................................................................................................................................... 4
1.2 Disclaimer ............................................................................................................................... 4
1.3 Information on the document ............................................................................................. 4
2 Notes and symbols ......................................................................................................................... 5
2.1 Read and abide by the manual ......................................................................................... 5
2.2 Symbols ................................................................................................................................... 5
2.3 Warning and safety notes .................................................................................................... 7
2.3.1 Starting-up the medical device ...................................................................................... 7
2.3.2 Treatment and operation ................................................................................................. 8
2.3.3 Cleaning, maintenance and servicing ........................................................................ 10
2.3.4 Medical device malfunction ......................................................................................... 11
2.3.5 Unexpected events ........................................................................................................ 12
2.3.6 Performance characteristics.......................................................................................... 12
3 Intended Use, Indications for Use, Side Effects, Complications, and Contraindications .... 13
3.1 Intended use ........................................................................................................................ 13
3.2 plasma care® is adjunctive therapy ................................................................................ 13
3.3 Indications for Use ............................................................................................................... 13
3.4 Side effects / Contraindications ........................................................................................ 13
4 Operator and Patient Profiles ..................................................................................................... 14
4.1 Operator ............................................................................................................................... 14
4.2 Patient Profile ....................................................................................................................... 14
5 Delivery contents ......................................................................................................................... 15
6 Description of the plasma care® ............................................................................................... 16
6.1 plasma care® components ............................................................................................... 16
6.2 plasma care® user interface ............................................................................................. 16
6.3 plasma care® spacer ......................................................................................................... 16
6.4 User interface ....................................................................................................................... 17
7 Starting the plasma care® .......................................................................................................... 19
8 Treatment ...................................................................................................................................... 21
8.1 Performing a treatment with the plasma care® ............................................................. 21
8.2 Attaching and removing the spacer ................................................................................ 23
8.2.1 Attaching the spacer ..................................................................................................... 23
8.2.2 Removing the spacer ..................................................................................................... 24
8.3 Treating wounds with the plasma care® ......................................................................... 24
Adjunctive use of the plasma care® for decontamination .............................................. 24
8.3.1 ................................................................................................................................................ 24
8.3.2 Techniques for larger wounds ........................................................................................ 25