Myo 200
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1.2.5 Electrotherapy
1.3 Medical Devices Directive
The device complies with the essential requirements of the Medical Device
Directive of the European Committee (93/42/EEC) as most recently
changed.
The device contains no human or animal tissue, no medical substances, and
no blood or blood products from human or animal origin.
1.4 Liability
The manufacturer cannot be held liable for injury to the therapist, the
patient or third parties, or for damage to or by the equipment used, if for
example:
•an incorrect diagnosis is made;
•the equipment or the accessories are used incorrectly;
•the user instructions are wrongly interpreted or ignored;
•the equipment is badly maintained;
•maintenance or repairs are performed by people or organisations that
are not authorised to do so by GymnaUniphy.
Neither the manufacturer nor the local GymnaUniphy dealer can be held
liable, in any way whatsoever, for the transfer of infections via the vaginal,
anal and rectal probes and/or other accessories.
•Do not use the equipment simultaneously with high frequency
surgical equipment. This combination can cause burning of
the skin under the electrodes.
•Do not use adhesive electrodes with currents that have a
galvanic component, such as galvanic, diadynamic, MF
rectangular, pulsed rectangular and triangular currents. With
these currents, etching of the skin can occur.
•Application of electrodes near the thorax may increase the risk
of cardiac fibrillation.
•Check the electrode cables, the electrodes and the probes at
least once a month. Check whether the insulation is still
intact. See §5.1.
•The safety standards for electrical stimulation advise not to
exceed the current density of 2.0 mArms/cm2.
However, with iontophoresis treatments, we advise a
maximum current density of 0.25 mÂ/cm2, because of using
the MF rectangular current. Exceeding this value can result in
skin irritation and burns.
•Always use sterilised gauze with iontophoresis treatments.
OBJ_BUCH-39-001.book Page 9 Friday, January 23, 2009 12:05 PM
