27. Before the treatment any sharp objects (knives, scissors, needles, pens
pencils, glasses etc.) have to be left far away from the waterbed.
28. Using waterbed mattress without checking its sufficient amount of water
can be dangerous, the patient could be burnt.
29. The water in the mattress must be heated up before the treatment. You
can find its detailed description in the ‘Preparation before treatment’
section of this user’s manual.
30. Accessory equipment connected to the analogue and digital
interfaces must be certified according to the respective IEC standards
(e.g. IEC 60950 for data processing equipment and IEC 60601-1 for
medical equipment). Furthermore, all configurations shall comply with
the system standard IEC 60601-1-1. Everybody who connects additional
equipment to the signal input part or signal output part configures a
medical system, and is therefore responsible that the system complies
with the requirements of the system standard IEC 60601-1-1. If in doubt,
consult the technical service department or your local representative.
31. Oncothermia does not substitute the conventional therapies only
supports those.
Resident risks:
The user has to follow the instructions mentioned above otherwise burning or
overheating of the tissue can occur.
The temperature calculation (displayed temperature) is only a calculation. Note,
Bear in mind that the temperature of some points of the heated local area can be
considerably higher than the average. This effect is called “hot spots” in the
literature. This inaccuracy can cause overheating of the tissue.
The calculation however is based on the so-called “equivalent temperature”
idea. This means that Electro-Hyperthermia heats up the tissue by a dynamic,
gradient method. The calculated temperature - has the same distortion ability of
the cells as the static overheating. This temperature (due to the dynamical
effects) in reality could be lower than the statically measurable one. Tolerated
accuracy of forwarded and reflected power (±30%) is checked at the start but is
not checked continuously during the treatment. This can cause overheating of
the tissue.
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