KaWe SwiSto 3, User Manual

18

Separate disposal of electric and electronic devices
Manufacturer
Date of manufacture
Lot code
Complies with relevant EU guidelines

iP41

Protected against water droplets and solid matter with a 
diameter of greater than or equal to 1.0mm

REF

Product reference number

SN

Series number
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.