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User Manual – Alsatom SU-MPC (SU50, SU100, SU140)
These devices are manufactured by ALSA Apparecchi Medicali s.r.l. – Castel Maggiore (Bologna - Italy) – Phone +39.051.700.101.
which is responsible for their functioning, liability and safety only if devices are used in an area that meets IEC Standards, if the installation
and the use are performed in compliance with the information of this manual and if repairs or periodical checks are carried out by authorized
personnel who use original spare parts.
On request, ALSA will provide users with related electric diagrams and/or any further technical or practical information.
In accordance to the European MDD users are kindly invited to communicate to the company, directly or through the local distributor, any
problems of these devices in order to intervene as soon
BE CAREFUL – Not modifiy devices and use them only if the mains supply is provided with an efficient earth protection.
INTENDED USERS – USE OF THIS MANUAL – INDEX OF TOPICS
These devices must be used only for the purposes listed in this manual and only in OT / similar places by qualified operators who are
experienced in electro-surgery and all related problems, risks and undesired side effects. Users must do the following:
Before starting the use of this device, they must read this manual carefully; in addition they must check the unit performance without
considering only previous experiences with similar devices and contact the company if it is not clear for their specific needs.
They must keep the manual where the device is used and replace it in case of loss.
They must contact the company, either directly or through the local distributor, to obtain the needed information or replace the manual.
INDEX
HIGH FREQUENCY SURGERY- PRINCIPLES, RISKS AND DIRECTIONS FOR USE
IMPORTANT WARNINGS (vital to use in the best and safest way the device)
USE – IT INCLUDES FOLLOWING POINTS: Positioning, check of the mains supply and connection – Connection and use of foot-switches -
Connection of the neutral electrode and operation of the related alarm circuit - Connection of accessories -
Switching on and initial self-check – Setting and adjustement of currents - Temporization of the Micro coagulation (from 0.1 to 1 second) -
Activation of currents by foot and hand-switches - Memorization of settings and abnormal power delivery - Available currents, use and
starting settings -Adaptors and connecting cables for not standard accessories – Use of the RD/5 universal monopolar adaptors -
AUTOMATIC SELF-TEST SYSTEM (It includes a specific information about problems not detectable by self-checks).
HANDLING, STORAGE, CLEANING AND STERILIZATION, DISPOSAL
CONSUMABLES, PERIODICAL CHECKS AND FINAL DISPOSAL
TECHNICAL DATA – IT INCLUDES FOLLOWING POINTS: Technical features – Environmental conditions of use – Currents and powers – Controls
and symbols, Connection of the foot-switch - Currents diagrams
GENERAL LIST OF MONOPOLAR AND BIPOLAR ACCESSORIES
HIGH FREQUENCY SURGERY – PRINCIPLES, RISKS AND DIRECTIONS FOR USE
When electrical currents flow across biological tissues, they produce 3 effects: Electrolytic, Faradic and Thermal.
If the current has a frequency higher than 300kHz, the thermal effects remains above all and it is exploited to obtain the desired surgical
result; in fact when an electric current with such characteristics crosses with sufficient density the cellular liquid of tissues, it warms in
different ways and generates what follows:
A vapor pressure into liquids of cells very high which is able to provoke the explosion/destruction of their membranes: Pure Cut;
A slower heating of liquids which permits their evaporation; in this way, tissues and vessels shrink and stop the bleeding: Coagulation;
A process that is in the middle between phenomena above: Coagulating Cut.
HF SURGICAL CURRENTS ARE USABLE IN TWO MODES: MONOPOLAR AND BIPOLAR.
MONOPOLAR MODE. It requires the use of two electrodes (the active one, small and used by the operator; the neutral one, large and fixed
on a different part of the patient’s body) and the current flows from the first to the second electrode.
Obviously, the thermal effect affects with different intensities all tissues included between electrodes.
BIPOLAR MODE. This mode requires the use of one instrument including both electrodes that are very close and the thermal effect affects
only a very small quantity of tissues.
RISKS CAUSED BY THE USE OF HF CURRENTS.
These currents are vital to solve many surgical needs, but they cause also some risks and unexpected side effects, mainly while using the
monopolar mode. For example:
Burns on the patient’s tissues where operators place the neutral electrode caused by not sufficient/bad contact.
Burns on the surgeon’s hand when the insulation of the active electrodes/instruments is damaged;
Severe burns of patients /users caused by the ignition/explosion of flammable/explosive gases or substances.
In fact, the normal sparks generated during the delivery of powers can ignite them.
Bad functioning of other devices (pace-maker, video systems) provoked by EMC interferences emitted during the power delivery;
Unexpected damages of the patient’s tissues caused by a delivery of too high powers.
Notably while using currents for coagulation, neuromuscular stimulations felt by patients or surgeons like “an electrical discharge”.
To reduce these risks, International IEC standards establish both all the hardware/software measures to apply and all warnings to include in
the User manual that users must comply carefully because their behavior is vital to eliminate or, at least, to reduce these risks.
ALSATOM SU-MPC - DIRECTIONS FOR USE
Alsatom are usable for following uses: Monopolar cut / coagulating cut, Monopolar coagulation, Monopolar cut or coagulation under liquid
by using small instruments and Bipolar coagulation during all operations of small/medium surgery in surgeries, OT and similar places.
Alsatom are usable for following fields: Gynaecology, Dermatology, Plastic and Aesthetic Surgery, ORL, Maxillofacial Surgery, Other
Surgeries, Gastroenterology, Veterinary.
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