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OMNIA-RF4 RADIOCAUTERY PRESENTATION

Radiofrequency electrosurgical generators usually function at a high enough frequency so as to prevent neuromuscular reactions and reduce the risk of electrocution.

Studies show that neuromuscular reactions do not occur above 200 kHz and the risk of electrocution decreases considerably as well because the electric current is better controlled at high frequency, from the point of view of conduction pathway, decreasing the uncontrolled leakage outside the current path as minimum resistance will be only in the current path. In this way, the current flow path becomes much more directional.

OMNIA- RF4 is a programmable surgical radiofrequency generator having 2 operation modes:

- monopolar mode with pure cut, cut combined with coagulation (blend) and coagulation;

- bipolar operating mode with bipolar coagulation, applicable in all surgical fields;

Numerous surgical apparatus used in various surgical fields are known, but they have the disadvantages of working in the intermittent operating modes of 1/3, they can not be programmed before the surgery, they lack the possibility to personalize and update the operating modes and power depending on the specific needs of surgery, or they work only superficial coagulation.

OMNIA- RF4 performs all types of operations in surgery, starting with pure cutting; cutting combined with low, medium and high coagulation degree; hot and cold coagulation for all types of tissues depending on the bleeding and vascularization degree, in both monopolar mode and cutting combined with coagulation, or pure coagulation in bipolar mode.

OMNIA-RF4 has specific operating modes for each surgery, with the possibility of programming and preparation before surgery, having a system of continuous use.

FEATURES

The programmable surgical radiofrequency generator of 100, 140, 180 W has the following features:

● 4 MHz working frequency

● 100,140, 180 W power cut

● 2 working procedures and 8 operating modes:

● output radiofrequency current form – unmodulated or modulated sinusoidal in continuance with modulation grade (duty cycle), specific to each operating mode;

● simplified mode of operating (a single button is used)

● the device can be programmed before surgery

● maximum overall dimensions: Height = 165 mm; Width= 400 mm; Length= 500 mm

● protection degree – IP 31

● automatic adjustment of prescribed power output for load impedance variation in the range of 50 to 300 ohm;

● ensuring compliance with electrical safety requirements: SR EN 60601-1 and 61601-2;

● main sizes to be viewed, selected and adjusted of the parameters are shown on a display device;

● the item for adjustment and typing is reliable and ergonomic for easy and quick handling complying with the SR EN 60601-1 -6/2009 and SR EN 60601-1-8/2009 standards;

● the colour code for output connectors like visual warnings are complying with the SR EN 60601-2 standard;

● the unit mass does not exceed 12 kg.

BENEFITS OFFERED BY OMNIA-RF4

- The frequency of 4 MHz, from a medical point of view, makes an incision with great precision and with reduced collateral thermal effects, as well as a cauterization with improved healing degree;

In terms of electro-security, given the very high work frequency, the danger of electric sock to the patient closed circuit is significantly reduced.

In terms of practical realization of a radiofrequency power generator, given the relatively high working frequency, the physical dimensions of the circuits are reduced, because of the values of inductances and low capacities and of adaptation transformers.

- The sinusoidal output current shape allows maximum thermal effect at minimum peak values.

- The output power of the device is selected depending on the segment of specialty of its domain of utilization; the device will be equipped with an automatic control circuit of the prescribed power output under the conditions of load variation (variations in the tissue impedance) in the range of 50…300 ohms.

OPERATING MODES

The working procedures as well as the operating modes are established according to the requirements of the surgical field, as follows:

The monopolar mode includes the following operating modes:

● Pure cut with unmodulated sinusoidal current form;

● Cutting-coagulation with low coagulation degree;

● Cutting-coagulation with medium coagulation degree;

● Cutting-coagulation with increased coagulation degree;

● Deep coagulation for highly perfused tissues;

● Surface coagulation for poorly perfused tissues;

The bipolar mode includes the following operating modes:

● Bipolar cutting-coagulation;

● Bipolar coagulation

INNOVATIONS

- The simplicity of operation is given by using a single button, namely a touch-encounter button that by pressing allows you to change the operating modes and working procedures, and by turning allows you to prescribe the output power value. Furthermore, by storing the prescribed values you eliminate the readjusting of the already prescribed values when changing the operating modes. The selection of the operating modes and working procedures as well as the prescribed values of the output power can be visualized on a colour graphic display.

- In order to meet the security requirements, the device is designed to respond to the general requirements for medical devices stipulated by the EN60601-1 standard and those for electro-security of radiosurgery devices stipulated by the EN60601-2 standard;

- To avoid the accidental ingress of liquids during operation, the device is provided with a special case that ensures protection complying with the IP31 standard;

- Internal power supplies of the switching mode (SMPS) are used in order to reduce the mass and dimensions of the device;

The device is powered from a 230 Vac, 50 Hz network.

BENEFITS OF RADIOSURGERY

Radiosurgery has many advantages compared with scalpel, electrocautery or laser incisions:

● Incision without pressure or tension, therefore the tissue doesn’t move or slip

● Optimal hemostatic control with significant reduction of blood loss, surgery length, patient’s pain and surgeon’s tiredness, during and after surgery

● It allows local or topical anesthesia instead of conventional infiltration techniques

● It prevents the microbial infection of the incision

● The sterilizing effect of the radio waves keeps the electrode in a sterile state

● The adaptation of the electrode cutting shape after anatomical variations as well as for cavities surgery too

● It requires minimum safety measures compared with laser surgery

● Minimal damage after biopsy using radiosurgery compared with CO2 and Nd: Yag lasers. The peri and intra-incisional tissue protection allows the proper harvesting of tissue pieces through biopsy for the standard histopathological evaluation and also for genetic and immunohistochemical study by increasing the use of these medical devices in surgical oncology and preoncology.

● Delicate coagulation due to the interaction of hydrogen bonds by catalyzing the natural process of distortion

● Faster tissue separation compared with traditional low frequency electro-medical devices that increase the temperature faster, sometimes up to 800 degrees Celsius near the area of the incision causing cell necrosis only to some microns intra and peri-incision. The coagulation when using the frequency modulated radio waves scalpel is done at below 100 degrees Celsius, therefore it doesn’t cause necrotic areas and improves recovery reducing the healing time a lot.

● Reduced incidence of postoperative complications especially of those caused by thermal aggression

● Pain is significantly reduced and healing time is shorter.

●By adjusting the electric power and by using thin electrodes, even the angular ones, the treating of very dense formations located in inaccessible areas to traditional devices is possible.

Thanks to its many benefits, the radiosurgery can be used in most of the surgical specialties: general surgery, gynecology, urology, otorhinolaryngology (ENT), ophthalmology, neurological surgery, plastic and reconstructive surgery, aesthetic surgery, cardiovascular surgery, thoracic surgery, dermatology, orthopedics, dentistry, surgical oncology and preoncology, oral and maxillofacial surgery, phlebology, neurology, pediatrics and so on.

FUNCTIONS OF OMNIA RF4-100W RADIOSURGERY DEVICE:

 ● without having self-heating, electrodes act on the tissue through cutting, hemostasis and coagulation generated by Joule’s heat production

● high frequency voltage 4 MHz ensures the surgery accuracy with minimum tissue side effects allowing a fast healing

● compact design with a peak power of 100W, 140W, 180W at 300Ω charging.

● lack of smell or smoke during surgery

● coagulation depth is determined by the electrode, the produced power and the operating time.

● because of the high frequency voltage being low, there will be no electrical spark, therefore no carbonization and no damage of the peri-incisional tissue

● lastingness and long life cycle

● monopolar and bipolar function

● pedal control (foot control), having total hands freedom

● only one pedal for the operating mode: cutting, coagulation, fulguration, bipolar

● visible digital display of the output power for each operating mode

● simple and convenient handling

CONTRAINDICATIONS AND PRECAUTIONS

● excessive collateral tissue damage in case of surgical errors, especially of beginners

● radiosurgery mustn’t be used in the presence of flammable liquids, of flammable anesthetics.

● possibility of interfering with other electro-medical equipment such as cardiac defibrillators, pacemakers and ECG monitors.

● in case of patients with pacemakers and defibrillators, it’s safer to use the bipolar as the current is concentrated between peaks and not in the patient – it is not used in the cardiovascular surgery.

CONCLUSIONS

● The new technology of radiosurgery brings numerous benefits to the surgical field, being applicable to all surgical specialties.

● The heat and minimal lateral tissue destruction, the controlled hemostasis, the rapid healing, improved safety for the physician and patient as well as the reduced costs are a few important advantages.