Foreword; Intended Use; Safety Information - plasmamedicalsystems Plasma ONE Benutzerhandbuch

Foreword

1

Intended use

Dear colleagues, dear
surgery team,
to give you an overview
of the future-oriented
key technology which
you have purchased,
I would like to explain
the intended use of
plasma ONE.
Dr. Susanne Pavisic
The main idea behind
our commercial philosophy
and actions is the heath of
each individual member of
the population as a whole.
The intended use of the medical product which you
have purchased, plasma ONE, is disinfection!
Fields of application: dermatology, gynaecology, urol-
ogy, surgery and dentistry.
User group: Physicians and specialist medical person-
nal.
The fact that plasma has antimicrobial properties is
well known and has been scientifically researched
and published throughout the world. The publica-
tions talk about cold plasma as well as cold atmos-
pheric air plasma.
The causes of the antibacterial effect of plasma are
due to heat, dehydration, shear forces, UV radiation,
free radicals and charges. With cold plasmas, heat
plays a subordinate role, as they will be practised at
room temperature.
Particularly reactive radicals are generated in atmos-
pheric plasmas. These include atomic oxygen, super-
oxide radicals, hydroxyl radicals, carbon monoxide
and nitrogen dioxide.
These have a destructive effect on various cell com-
ponents. If the cell walls of bacteria are directly ex-
posed to the plasma, they become negatively
charged due to bombardment by the electrons which
are present in the plasma. The resulting electrostatic
repulsion causes mechanical stresses, which can ex-
ceed the tensile strength of the cell wall and hence
destroy it.
Bombardment with such particles can change or de-
stroy the structural integrity of the cells.
Cold plasma is the name which is given to plasma
with a low temperature.
From a physical point of view, hot plasmas are in a
state of thermal equilibrium with themselves and
their environment, while cold plasma is not in such a
state of equilibrium.
The plasma MEDICAL SYSTEMS® technology uses am-
bient air for ionisation.
A further special feature of the medical product
plasma ONE is that it is only operated with battery
power.
It does not work with or by means of mains voltage.
The safe, low voltage used in battery operation pro-
vides a high level of safety, with a reduction in path-
ogens of up to 99.9 %!
The energy charged species in cold plasma are le-
thal to microbes, but are completely safe for the
skin. (We will be glad to provide you with our litera-
ture research for the clinical assessment of plasma
ONE.
Yours sincerely
Dr./Univ. Zagreb Susanne Pavisic
Managing Director
Before starting use
2 Before starting use
It is essential that you read the instruction manual
carefully before starting to use your new plasma ONE.
As the operator of plasma ONE, strictly observe the in-
formation in the instruction manual!
We explicitly refer to the products listed by the RKI for
cleaning and sterilisation and to the Medical Devices
Operator Ordinance (MPBetreibV) for the use of medi-
cal products.
The plasma ONE REF 1001001/002 is suitable for use
in all facilities, including domestic environments and
those which are directly connected to the PUBLIC
SUPPLY GRID which also supplies buildings which are
used for dwelling purposes.
The ambient and operating conditions are:
Ambient temperature 15 – 45° C
Relative humidity 40 – 85 %
Air pressure 800 – 1014 hPa
Operating mode: NOT FOR CONTINUOUS OPERATION
Max. activation time: 2.5 minutes
Min. deactivation time: 10 seconds
2.1

Safety information

Note that glass is sensitive to breakage. The in-
n
strument probes must be handled with care.
(Page 7-8)
The warning information and the hygiene regu-
n
lations must be communicated to the practice
team by keeping records and must be complied
with.
(Page 9-11)
The list of contraindications must be read care-
n
fully and must be complied with by the practice
team.
(Page 10)
Use our list of recommended indications, so
n
that you can achieve safe and successful treat-
ment from the very start. The list of recom-
mended indications is an accessory and can be
requested at any time, free of charge.
In case of faults or problems you can find initial
n
information in the Solutions table.
n The service centre can be contacted under the
hotline 0049(0)260393128-0 or
Mail: support@plasmamedicalsystems.com.
Before using the medical product for
the first time it must be disinfected or
sterilised . The regulations of
(Page 11)
the MPBetreibV must be observed.
2.2 Completeness
Please check that the contents of the
package are complete.
5, 5a
7 1 4 3
6, 6a
2 8 9
Dental Pack Medical Pack
1 Energy control unit 1 Energy control unit
2 Mains unit 2 Mains unit
3 4
Dental converter Medical converter
5 6
Instrument probes Instrument probes
5 Dental + 5a suitable 6 Medical + 6a suitable
6 sterilization basket 6 sterilization basket
7 7
Patient probe Patient probe
8 8
Recommended Recommended
8 indications 8 indications
9 Instruction Manual 9 Instruction manual
10 10
Declaration of Declaration of
10 10
Conformity Conformity
plasma ONE · Instruction Manual
10
4-5