Inhaltsverzeichnis
Werbung
Verfügbare Sprachen
Verfügbare Sprachen
Warning information
The warranty only applies for original parts. Do not
use the treatment unit if electrical components are
damaged and report the condition to plasma MEDI-
CAL SYSTEMS® GmbH or the vendor or authorised
dealer.
Avoid direct contact of the probe with latex materials
when the device is in operation.
Some materials do not react well with low tempera-
ture plasmas. (Please note the list of plasma compat-
ibility on
)
page 12
Although the treatment
time is relatively short,
use aspiration during
dental treatment, so
that the unused cold
plasma is eliminated
from the oral cavity. This
is mainly important if
the duration of treatment is longer than 2 minutes.
Keep the original packaging in case you have to re-
turn the treatment unit!
4.1
Counter-indications
For the sake of procedure, possible contraindications
are listed under 2, 3,
4
and 5, although no treatment
information is available, which could result in dam-
age to health or a negative effect on the patient due
to treatment with cold plasma.
Treatment must not be carried out of the patient has
a pacemaker (1) or any other active implant.
Therefore, we recommend that pa-
tients with active implants are not
given treatment!
1
With patients who have active implants
2
With patients who have severe neurological
functional disorders
3
With patients who have severe mental func-
tional disorders
4
With patients who have hypersensitivity reac-
tions to electric pulses
5
With patients with severe asthma
6
With pregnant patients
7
With patients with a diagnosis of hyperthyroid-
ism.
Please not that smaller doses should be used for the
treatment of children. This primarily applies to the
treatment of children's mucous membranes.
The intensity should not exceed level 2.
For all of the listed con-
traindications, the doc-
tor and the patient
must
jointly
agree
whether or not plasma
treatment is to be car-
ried out.
Warning information
4.2
Cleaning, disinfection
& sterilisation
Cleaning and disinfection of all original parts of the
plasma ONE must be carried out with disinfectants
and methods approved by the RKI. During all clean-
ing processes, careful handling of the glass probe is
essential in order to prevent breakage or damage.
The metal part of the instrument probe may not be
dumped down into liquid! The same applies for the
electronic parts of the device and the opening in the
handpiece. The whit silicon ring on the probe is used
to protect the opening in the converter.
1
Before the intended use, all components of the
plasma ONE medical device must be carefully
and thoroughly cleaned with an approved and
entirely manual method.
2
After this, the components of the device are dis-
infected with an RKI-approved agent for wiping
disinfection (e. g. isopropanol or ethanol) or an
approved thermal method at 121° C.
3
Sterilisation of the glass probes should only
be carried out for use of the plasma ONE in a
critical area of use (e.g. surgery or dentistry),
using the sterilisation method approved and
required by the RKI. Sterilisation of all glass
instrument probes, except for the PSKP, should
be performed in an autoclave at 134° C (up to
100x sterilisation cycles).
After each sterilisation and disinfection, the instru-
ment probes must be dried and properly stored. Their
function must be visually inspected before the next
use.
All parts of the device completely fulfil the safety re-
quirements. Because of this, the device must not
be used with instrument probes or other accessories
which are not included in the scope of delivery or
which have not been tested by the manufacturer.
Warning:
According to DIN IEC 60601-1 the
plasma ONE treatment unit must not
be opened or structurally modified
without the consent of the manufac-
turer!
4.3
Service & maintenance
The device is maintenance free. However, the Euro-
pean Ordinance and the Medical Products Act MPG
for medical devices require a safety inspection
every two years.
The plasma MEDICAL SYSTEMS® products must be in-
spected in an authorised service center or by the
manufacturer according to the MPBetreibV. In order
to prevent possible damage, please do not use any
components or device parts which are not plasma
MEDICAL SYSTEMS® original parts.
Please use the original packaging or the case for
stage or transport of the plasma MEDICAL SYSTEMS®
products.
The performance of glass instrument probes will
decrease in the course of time, especially if the in-
strument probes are frequently sterilised. Because of
this, we recommend that the instrument probes are
replaced every 12 months, depending on how often
they are used and sterilised.
plasma ONE · Instruction Manual
10-11
Werbung
Kapitel
Inhaltsverzeichnis
