Contraindications/Side Effects And Preventative Measures - KaWe SwiSto3 Mode D'emploi

Separate disposal of electric and electronic devices
Manufacturer
Date of manufacture
LOT Lot code
Complies with relevant EU guidelines
Protected against water droplets and solid matter with a
iP41
diameter of greater than or equal to 1.0mm
REF Product reference number
Series number
SN
Temperature limit
GOST-R certification of exports to Russia
7. Contraindications/side effects and preventative
measures
IMPORTANT! Vital information:
• Consult your physician before using this device to receive an indivi-
dualised treatment plan. Tap water iontophoresis may not be per-
formed under the following circumstances or if the patient has one
of the following conditions (contraindications):
- implanted electronic devices (i.e. pacemaker)
- pregnancy
- metal implants in the areas of the body through which the current is
conducted (arms or legs)
- metal-containing intrauterine devices (contraceptive coils) when
treating the feet
- large-sized skin defects that cannot be covered with Vaseline or iso-
lating bandages/wraps
- heart murmurs or insensitivity to pain.
The device may only be installed and operated in accordance with
the instructions given in the user's manual. Radios, mobile tele-
phones or other similar devices that may affect the device must be
placed at least 2 metres away from the device. The device may not
be used by unsupervised children and must be stored out of reach of
children.
The cables pose a risk of strangulation. Small parts may become
loose and could be swallowed or inhaled.
• Only use standard accessories provided by KaWe. The use of other
cables, charging devices, electrodes, water trays etc. is not allowed.
The use of non-standard parts can influence the EMC interference
immunity and electrical safety of the unit.
• Simultaneous treatment with another high-frequency surgical in-
strument may cause skin burns under or near the electrodes.
• The operation of the iontophoresis device within close range (ap-
prox. 1 m) of a short-wave or a microwave therapy unit can cause
fluctuations in the output readings of the iontophoresis device and
therefore, should be avoided.
• Never perform treatments during thunderstorms. If necessary, im-
mediately discontinue the treatment and turn off the unit.
• The maximum current and the maximum voltage are limited by
safety values that are determined by the regulations for electrical
medical devices, thereby eliminating the risk of harm to the patient.
• Electrical shocks are primarily caused by contact failures between
the connector cables and the electrodes. Over time, transfer resist-
ance occurs between the electrodes and the connector cables due
to the direct contact with water. This can be avoided by disconnect-
ing the cable on the electrode just before beginning treatment and
then reinserting it with a twisting motion. The friction thereby pro-
duced creates a clean metal-to-metal contact which is essential for
a constant flow of current. This practically eliminates uncomfortable
current peaks that could otherwise be felt by the patient.
• Persons with prosthetics must remove these before treatment. They
must also consult a doctor before using this device.
• It is essential that the patient ensure that the success of the treat-
ment is not affected by any type of disturbance. Due to this reason
as well for electrical safety reasons, it must be ensured that no chil-
dren or house pets are allowed in the room at the time of treatment.
• The patient should be aware of the fact that – especially during
underarm perspiration treatment – any rash movement during the
treatment can alter the surface on the body being used for the cur-
rent transfer. As a result, the current load on the affected body part
may exceed the allowed value, which although it cannot cause ac-
tual harm, could potentially cause discomfort, skin irritation and/or
slight burns. Such complications can be best avoided by:
- Avoiding direct metal contact between the electrodes and the body
by using the foam pads or sponge pockets.
- Removing the hands and/or feet slowly from the water trays while
the treatment current is flowing.
- Ensuring that the electrodes are always fully inserted into the
sponge pockets during underarm perspiration treatments.
- Ensuring that during underarm perspiration treatment the contact
pressure between the sponge pocket and the underarm remains as
constant as possible for the entire treatment time.
• Direct current tap water iontophoresis is not suitable for sensitive
users as it may cause skin irritation or paresthesia. In order to mini-
mize these side effects, this device is to be used with pulsed current
and the current must not exceed given amperage. Nevertheless,
while using pulsed current, slight stinging, burning or tingling sen-
sations or a slight reddening of the treated skin areas may still occur.
In order to prevent these side effects, the sponge pockets should
only be lightly and evenly moistened and not soaked before they
are placed under the armpits.
• Cover damaged/rough areas of the skin on the palms of the hands,
the soles of the feet and the grooves of the nails with Vaseline or
another greasy ointment, since the electrical current transmissibility
through these areas is increased.
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