Instruction Manual
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MA362_EN Instruction’s Manual
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SURTRON 80 – 120 - 160 LED SpA Summary
IMPORTANT------------------------------------------------------------ 3 INTRODUCTION ------------------------------------------------------- 4 Destination of Use / Sectors of Application ---------------------- 4 Standard and Optional Composition ------------------------------ 5 General Description -------------------------------------------------- 7 ELECTROPHYSICAL PRINCIPLES ---------------------------------- 8 OPERATIVE TECHNICS ---------------------------------------------- 12 Monopolar Cut --------------------------------------------------------- 12 Monopolar Coagulation ---------------------------------------------- 12 Bipolar Coagulation--------------------------------------------------- 13 CONTRAINDICATIONS AND COLLATERAL EFFECTS ---------- 14 SAFETY ------------------------------------------------------------------ 15 General ------------------------------------------------------------------ 15 Installation ------------------------------------------------------------- 18 Safety for the Patient ------------------------------------------------- 19 HF Electrosurgical in Laparoscopy -------------------------------- 22 INSTALLATION -------------------------------------------------------- 24 CONNECTOR AND CONTROLS -------------------------------------- 29 Label on the Rear Panel ---------------------------------------------- 29 Manufacturer’s Identification Data -------------------------------- 29 Meaning of Grafhic Symbols ---------------------------------------- 29 Frontal Panel ----------------------------------------------------------- 30 Operation Mode ------------------------------------------------------- 31 Switch On --------------------------------------------------------------- 31 Neutral Electrode’s Circuit ------------------------------------------ 31 Preselection of the Deliverable Current -------------------------- 32 Cut Current (CUT) ----------------------------------------------------- 32 Coagulated-Cut Current (BLEND) --------------------------------- 32 Superficial Coagulation Current (FORCED COAG) -------------- 32 Deep Coagulation Current (SOFT COAG) ------------------------- 33 Bipolar Coagulation Current (BIPOLAR) ------------------------- 33
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Instruction’s Manual
Manuale d’Istruzioni
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EN-1 MA362c_EN
EN-2 Instruction’s Manual MA362c_EN
Signaling of Excessive Time of Delivery (OVT) ------------------ 33 Signaling of Excessive Impedance in the Circuit of Neutral Electrode (OC) --------------------------------------------------------- 34 Adjustment of the Acoustic Signal Level-------------------------- 34 Automatic Control of the Internal Parameters ------------------ 34 Connectors ------------------------------------------------------------- 35 Back Panel -------------------------------------------------------------- 36 Power Supply Module and Voltage Selector --------------------- 36 Power On-Off Switch ------------------------------------------------- 36 TECHNICAL CHARACTERISTICS ----------------------------------- 37 MAINTENANCE -------------------------------------------------------- 39 General ------------------------------------------------------------------ 39 Cleaning of the Cabinet ---------------------------------------------- 39 Cleaning and Sterilisation of the Accessories Items ------------ 39 Guide to the Solution of the Problems ---------------------------- 40 Repairs ------------------------------------------------------------------ 41 Fuses Substitution ---------------------------------------------------- 41 Checking of the Equipment Before Each Use -------------------- 41 Function and Safety Check and Test------------------------------- 42 DIAGRAMS -------------------------------------------------------------- 43
SURTRON 80 – 120 - 160 LED SpA
IMPORTANT These operating instructions form an integral part of the equipment and must be available to the operating personnel at all times. All the safety instructions and advice notes are to be observed. Be sure that these operating instructions are furnished together the equipment when this is transferred to other operating people. In case of necessity of technical, or other type, assistance contact your own retailer.
Produttore / Manufacturer
LED SpA
PROGETTAZIONI E PRODUZIONI ELETTRONICHE Via Selciatella, 40 04011 APRILIA (LT) ITALIA www.led.it
MA362C_EN
Edition 04.2018
2018 © LED SpA
No part of this document could be photocopied, reproduced or translated in other language without the written consent of LED SpA. All right reserved. SURTRON and LED logo are registered trademarks of LED SpA.
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Instruction’s Manual
Manuale d’Istruzioni
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EN-3 MA362c_EN
EN-4 Instruction’s Manual MA362c_EN
INTRODUCTION Destination of Use / Sectors of Application The use of HF electro surgical equipment SURTRON® 80 – 120 – 160 has reserved to specialized medical personnel. The equipment has destined to a temporary use, for surgical operations in emergency room. It has foreseen its use in the monopolar cut, cut coagulated or coagulation mode or in bipolar coagulation mode. The equipment is conceived for being used in the following sectors: Description Electrosurgical unit code Casualty Surgery Dental Dermatology Endoscopy First Aid Gastroenterology Gynecology Neurosurgery Orthopedics Otorhinolaryngology Pediatric Surgery Plastic Surgery Pneumology Urology Vascular Surgery Veterinary
= Recommended = Usable = Not Recommended
80 10100.101
SURTRON ® 120 10100.201
160 10100.301
SURTRON 80 – 120 - 160 LED SpA
EN-5 MA362c_EN
Standard and Optional Composition SURTRON ®
Code
Description
- 00100.03 00202.00 00205.00 00304.00 00404.08 00500.00 5365A 00100.00 00100.01 00100.04 00100.05 00100.07 00100.09 00100.10 00201.02 00206.00 00305.03 00400.00 00401.00 00401.01 00401.02 00401.03 00402.00 00402.01 00402.02 00404.07 00411.00 00498.00 00500.00/L 0350 152-110 152-112 152-115 152-120 152-122 152-125 152-130 152-132 152-140 152-142 152-145 152-150 152-152 152-160 152-162 152-165 152-175-10 152-190-13 152-190-20 152-195
Electrosurgical unit code Power supply cable 2m SIE-IEC Holter for handle and electrodes PENCIL S - Handle with switch Waterproof foot switch Cable for connect.neutral electrode disposa.type /5365 ELECTRODE - Kit of assorted electrodes(10pcs) 5cm NEUTRAL - Steel neutral electrode 120x160mm Power supply cable 2m IT-IEC Power supply cable 5m SIE-IEC Power supply cable 2m USA-IEC Power supply cable 2m GB-IEC Power supply cable 2m BR-IEC Power supply cable 2m AU-IEC Power supply cable 5m JP-IEC PENCIL - Handle for microsurgical needle autoclvable PENCIL - Handle without switch Double water-proof foot switch Rod neutral electrode with cable NEUTRAL - Steel neutral electrode 120x160mm with cable NEUTRAL - Steel neutral electrode 240x160mm with cable NEUTRAL - Steel neutral electrode 120x160mm with cable autoclavable NEUTRAL - Steel neutral electrode 240x160mm with cable autoclavable CONNECTION - Monopolar cable M4-F4 3mt CONNECTION - Monopolar cable M4-F2.8 3mt CONNECTION - Monopolar cable M4-MP4 3mt Cable for connection neutral electrode F7915/F7930 ELECTRODE - Bipolar cable 3mt EUR ELECTRODE - Bipolar adapter ELECTRODE - Kit of assorted electrode length 10cm (10pcs) Disposable Neutral electrode (F7805) ELECTRODE - Blade electrode 7 cm ELECTRODE - Blade curved electrode 7 cm ELECTRODE - Blade electrode 16 cm ELECTRODE - Needle electrode 7 cm ELECTRODE - Needle curved electrode 7 cm ELECTRODE - Needle electrode 13 cm ELECTRODE - Ball electrode 2mm 6 cm ELECTRODE - Ball curved electrode 2mm 6 cm ELECTRODE - Ball electrode 3mm 6 cm ELECTRODE - Ball curved electrode 3mm 5 cm ELECTRODE - Ball electrode 3mm 14 cm ELECTRODE - Ball electrode 4mm 6 cm ELECTRODE - Ball curved electrode 4mm 6 cm ELECTRODE - Ball electrode 5mm 6 cm ELECTRODE - Ball curved electrode 5mm 6 cm ELECTRODE - Ball electrode 5mm 14 cm ELECTRODE - Loop electrode 10x10 l.15 cm ELECTRODE - Loop electrode 20x13 l.15 cm ELECTRODE - Loop electrode 20x20 l.15 cm ELECTRODE - Conization electrode 13 cm
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80
120
160
10100.101A
10100.201A
10100.301A
/1 /1 /1 /1 /1 /1 /1
/1 /1 /1 /1 /1 /1 /1
/1 /1 /1 /1 /1 /1 /1
Instruction’s Manual
Manuale d’Istruzioni
ENGLISH
ITALIANO
EN-6 Instruction’s Manual MA362c_EN
SURTRON ®
Code
Description
310-110-05 310-112-05 310-140-10 310-140-20 310-142-10 310-142-20 310-180-10 310-180-20 310-182-10 310-185-10 310-510 310-550 310-590 330-134-20 330-160 500500.L1 500500.L1/L 500500.L10 500500.L10/L 500500.L11 500500.L2 500500.L2/L 500500.L3 500500.L3/L 500500.L4 500500.L4/L 500500.L5 500500.L5/L 500500.L6 500500.L6/L 500500.L7 500500.L7/L 500500.L8 500500.L8/L 500500.L9 500500.L9/L 6429A 755VL F7520 F7915 F7920 F7930 TR003 TR003W TR004 TR005 TR005W
BIPOLAR - Bipolar Forceps 11,5cm TIP0.5mm BIPOLAR - Bipolar Forceps Curved 11,5cm TIP0.5mm BIPOLAR - Bipolar Forceps 20cm TIP 1mm BIPOLAR - Bipolar Forceps 20cm TIP 2mm BIPOLAR - Bipolar Forceps Curved 20cm TIP 1mm BIPOLAR - Bipolar Forceps Curved 20cm TIP 2mm BIPOLAR - Bipolar Forceps Angled 20cm TIP 1mm BIPOLAR - Bipolar Forceps Angled 20cm TIP 2mm BIPOLAR - Bipolar Forceps Angled Curved 20cm TIP 1mm BIPOLAR - Bipolar Forceps Angled Curved 20cm TIP 1mm BIPOLAR - Bipolar electrode 20cm – direct BIPOLAR - Bipolar electrode 20cm – curved BIPOLAR - Bipolar electrode 20cm – curved 2 MONOPOLAR - Monopolar Forceps 20cm TIP2mm MONOPOLAR - Monopolar Surgical Scissors 18cm ELECTRODE - Straight thin wire electrode (5pcs) 5cm ELECTRODE - Straight thin wire electrode (5pcs) 10cm ELECTRODE - Bent ball electro 3mm (5Pz) 5cm ELECTRODE - Bent ball electro 3mm (5Pz) 10cm Needles for micro-surgery (10Pcs) ELECTRODE - Bent thin wire electrode (5Pz) 5cm ELECTRODE - Bent thin wire electrode (5Pz) 10cm ELECTRODE - Loop electrode 4mm (5Pz) 5cm ELECTRODE - Loop electrode 4mm (5Pz) 10cm ELECTRODE - Loop electrode 8mm (5Pz) 5cm ELECTRODE - Loop electrode 8mm (5Pz) 10cm ELECTRODE - Bent hook electrode (5Pz) 5cm ELECTRODE - Bent hook electrode (5Pz) 10cm ELECTRODE - Bent thick wire electrode (5Pz) 5cm ELECTRODE - Bent thick wire electrode (5Pz) 10cm ELECTRODE - Drop electrode (L7) (5pcs)5 cm ELECTRODE - Drop electrode (L7) (5pcs)10cm ELECTRODE - Noose electrode (L8) (5pcs) 5 cm ELECTRODE - Noose electrode (L8) (5pcs) 10cm ELECTRODE - Straight ball electrode 3mm (5pcs) 5cm ELECTRODE - Straight ball electrode 3mm (5pcs) 10cm NEUTRAL - Steel neutral electrode 240x160mm Disposable handle with finger switches (F4797) Electrode cleaning sponge 47x50mm Conductive rubber neutral electrode without cable Disposable Split Neutral electrode (F7920) Conductive rubber split neutral electrode without cable Trolley 3 shelves Trolley 3 shelves wide Trolley 4 shelves Trolley 5 shelves Trolley 5 shelves wide
/ Pcs= STANDARD
= OPTIONAL
80
120
160
= NOT COMPATIBLE
SURTRON 80 – 120 - 160 LED SpA
General Description SURTRON® 80 – 120 - 160 are electro-surgical equipments suited to deliver current for monopolar cut, soft coagulation, forced coagulation or bipolar coagulation. The current can be delivered for the whole time of activation of the output circuit. It is possible to use either single plate neutral reference electrodes or electrodes with split conductive zone so to watch the plate to patient contact during the surgical intervention. Control of the units is via front panel keys and display; mains inlet is located on the rear panel. The units have automatic control systems that, monitoring the internal parameters, signal the possible damages/errors that are found. The operational parameters that are used are constantly stored so that, every time the unit is switched on or the operative method is changed, the last utilized parameters are recalled. The level of the emission sound can vary; every operator can choose his own level according to the noise of his working ambient. Power output can be active either through holder-handles with pushbuttons or through single or double foot switch command. Moreover, applying a special optional adapter it is possible the unit connection to bipolar forceps.
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Instruction’s Manual
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EN-7 MA362c_EN
EN-8 Instruction’s Manual MA362c_EN
ELECTROPHYSICAL PRINCIPLES In the electrosurgical interventations the traditional use of blade surgical is substituted by electrosurgical needle that allows making in a fast, simple and effective way the cut and coagulation of. The electrosurgical needle is made on the principle of electrical energy conversion in heat and it’s constituted by: a sinusoidal oscillator in radiofrequency; a generator of wave packets, with repetition frequency of packets equal to 15 – 30 kHz; a mixer for the transfer, to the power amplification block, of the only wave form adapt to the cut, or the only wave form for the coagulum, or a signal obtained by an opportune mixing of the two; a power amplification block able to supply the necessary power in terms of current and to transmit to the electrodes, by transformer, the amplified signal; a security circuit for the return electrode, to take possible cable interruptions and disarm the radiofrequency supply; by an active electrode opportunely shaped (handle); by a return electrode (neutral) that close the circuit by the patient. The current that crosses the biological tissue can cause: 1. Joule Effect 2. Faradic Effect 3. Electrolytic Effect
1) Joule Effect In the biological tissue, crossed by electrical current, it’s produced a heating (thermical effect), dependent by the electrical resistance of the tissue, by the current density, by the application time and that can determine many cellular transformations. Q = I2x R x T
SURTRON 80 – 120 - 160 LED SpA The thermical effect influence (Joule Effect) is made by:
Current Intensity and output power
Modulation level Parameters interpretable by the wave form of the high frequency current produced by the generator. Electrode shape The electrode shape can be needle or rounded according to the necessity, it has reduced dimension; for this the current density on the point surface [A· m-2] is highest. The electrodes with a thin section create a high current density, and high temperature, favoring the cut action. Those with a big surface create a smaller current density, a smaller temperature, realizing a coagulation effect. State of active electrode The thermical effects can be reported to the human body resistance, to which must be added the electrode contact resistance. It’s indispensable to maintain the active electrodes perfectly clean to not have a reduction of the. Characteristics of the tissue The resistive characteristics change according to the biological tissues. Biological tissue (range from 0,3 to 1 MHz)
Metals
Blood 0,16 x 103 Muscle, kidney, heart 0,2 x 103 Liver 0,3 x 103 Brain 0,7 x 103 Lung 1,0 x 103 Fat 3,3 x 103
Silver 0,16 x 10-5 Branch 0,17 x 10-5 Gold 0,22 x 10-5 Aluminum 0,29 x 10-5
(Example of specific resistances of organic and metallic materials)
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EN-9 MA362c_EN
EN-10 Instruction’s Manual MA362c_EN
According to the come temperature and in function of used pulse form, it’s possible to recognize many types of effects produced by the current in radiofrequency on the human body: Coagulation Temperatures from 60 to 70 ºC in the area around the active electrode cause a slow heating of intra-cellular liquid, the water contained in the cell evaporates and an action of coagulum is obtained, so the blood flow is stopped. Cut Temperature over 100 ºC in the area around the active electrode determines the evaporation of the intracellular liquid and the cell explosion. The vapor around the electrode baits a chain reaction in the direction where the active electrode is worked, transmitting the evaporation energy to the tissues around it. The cut isn’t, for this, a mechanical resection. If the temperature comes to 500 °C it’s verify the tissue with an action of cauterization. Mixed currents They are obtained by the mixing of coagulation and cut effects. There is a reduction of blood loss during the cut procedure, or like cut that develops a substantial eschar coat. The high frequency used by electrosurgical needle, don’t allow to the electromagnetic field to penetrate deeply in the matter and so the current crosses the conductor mostly in the external surface, reduces in an exponential way and becomes negligible in the centre of the conductor section. This effect, called ‘skin-effect’ cause a reduction of the useful section for the current passage, an increase of the electrical resistance and becomes an important problem in the neutral electrode. In fact in this electrode the current density is very high (KA/m2) on the edge, where the excessive increase of temperature by Joule effect causes burns for the patient. So it isn’t accidental that the burns for the patient, during the electrosurgical interventations, have the shape of the edge neutral electrode. To reduce the burns risk have to dose opportunely the supply power (I2·t) and to follow the rules for the application of the neutral electrode on the patient (see cap. SAFETY).
SURTRON 80 – 120 - 160 LED SpA
2) Faradic Effect The pulsed current causes the neuro-muscular stimulation, originated by stimulation of physiologic process of ionic exchange, responsible of the transmission of stimulus that cause muscular spasms and cardiac symptoms of extra systole and ventricular fibrillation. The effect of this stimulus is known like faradic effect and it is expressed by: R= I / √F The physiologic system of stimulus transmission follows a limit curve in which the pulsed currents or by low frequency produce an impulse of stimulation. By alternating current in high frequency (higher than 200 kHz), used in the electrosurgical needle, don’t have neuro-muscular reactions (the change of polarity is so fast that the patient doesn’t have consequences at a level of the neuro-muscular reactions), and there isn’t an electrolytic damage of the organism. For this reason all the equipments generator of the high frequency for surgical use (electrosurgical needle) work on base frequencies higher than 300 kHz so that they don’t produce electric stimulation.
3) Electrolytic Effect The use of high frequency currents reduces the electrolytic effect (ionic division) in the tissues, caused by the shortest period of unidirectional conduction of the current.
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EN-11 MA362c_EN
EN-12 Instruction’s Manual MA362c_EN
OPERATIVE TECHNICS Monopolar Cut Monopolar cut is the sectioning of the biological tissue achieved by the high-density passage of HF current, which is concentrated at point of the active electrode. The HF current, when it is applied to the tissue, through the point of the active electrode, it creates intense molecular heat in the cells so high that explosion of it is caused. The cut effect is achieved by moving the electrode through the tissue and destroying the cells one after the other. The movement of the electrode prevents the propagation of the side heat in the tissue, thus limiting to a single line the cells’ destruction. The best HF current for cutting is pure sine wave without any modulation that cuts very smoothly and provides the least thermal effect with poor haemostasis while cutting. Because its effects can be precisely controlled, it can be used safely without damage to the bone, but since good coagulation while cutting is one of principal benefits of using electro surgery a current with a certain amount of modulation is desirable. The following rules help the operator to obtain good cutting, however every user must follow first of all his professional judgment as he does every time in his practice. Keep the tissues moist but not wet; Survey the stroke before activate the electrode; Keep the electrode perpendicular to the tissue; Activate the electrode before making contact with the tissue; Maintain clean the electrode’s tip (the optional sponges F7520 to clean the electrodes are advised); Wait at least five seconds before to repeat a stroke. When the output power is properly set there should be: no resistance to the electrode movement through the tissue; no change in the cut surfaces color; no fibers of tissue remained onto the electrode.
Monopolar Coagulation Monopolar coagulation is the haemostasis of small blood vessel of the bodily tissue through passing of high frequency current in correspondence
SURTRON 80 – 120 - 160 LED SpA of active electrode. When the current density is reduced and a broad- surfaced electrode is used, to dissipate the energy over a larger area, the effect is to dry out the surface cells, without deep penetration, resulting in coagulation. These coagulate surface cells then serve as a layer of insulation, preventing heat derived by successive applications of current from penetrating too deeply. The current normally used for coagulation is modulated and depending from the modulation percentage is the smoothness of cutting, goodness of haemostasis and likelihood of tissue destruction. Deeper current modulation brings to somewhat roughly cutting and the chance of some slight depth of tissue destruction but more efficient coagulation. The following rules help the operator to obtain good coagulation: however every user must follow first of all his professional judgment as he does every time in his practice. Select a ball or heavy wire electrode; Locate the bleeder, after have wiped the excess blood from the area, contact lightly the bleeder before activating the electrode; Stop the electrode activation as soon as the tissue blanches to avoid tissue damage; Maintain clean the electrode’s tip (the optional sponges F7520 to clean the electrodes are advised).
Bipolar Coagulation Bipolar coagulation consists in the hemostais of small blood vessels of the body tissue between the two tips of the forceps. When the current density is reduced, the drying of the cellular surface is obtained, without deep penetration and its consequent coagulation. These superficially coagulated cells act as a layer of insulation that prevents the heat, due to successive current applications, to penetrate too deeply.
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Instruction’s Manual
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EN-13 MA362c_EN
EN-14 Instruction’s Manual MA362c_EN
CONTRAINDICATIONS AND COLLATERAL EFFECTS Electro surgery is not recommended in the following subjects: having pacemaker; with stimulating electrodes; with metal prosthesis plant; with important arterial pressure unbalance; with important nervous disorders; with renal insufficiency; in state of pregnancy. Burns are the most consequences of the HF electro surgery for the patient, even if these are not the only one. In fact necrosis by compression, allergic reactions to the disinfectant, gas or inflammable liquids ignition. Some important causes of burns are by: insufficient medical equipe training about all modalities to avoid or reduce the risks of burns by using HF electrosurgical units; use of disinfectants with high alcol content; incorrect position of the patient during the electrosurgical operation; contact between active electrode and the skin; contact with liquid; long application of HF currents; incorrect application of the patient-plate. To avoid or reduce the common HF electrosurgical risks it is very important to respect the rules and safety measurements exposed illustrate on the next chapter.
SURTRON 80 – 120 - 160 LED SpA
SAFETY WARNING: Electro-surgery can be dangerous. Careless use of any element in the electrosurgical system may subject the patient to a serious burn. Read and understand all warnings, precautions, and directions for use before attempt to use any active electrode. Neither LED SpA, can be considered responsible for personal, material or consequential injury, loss or damage that results from improper use of the equipment and accessories. The accessories supplied with the unit have characteristics compatible with this supplied unit, they could be incompatible with others electrosurgical units; the user must check, before connecting other accessories to this unit, that they have characteristics of insulation compatible with those of this unit and utilized function (see Technical Characteristics). It is recommended to inspect the integrity of the packaging of the sterile products.
General The following precautions reduce the risk of accidental burnings The whole surface of the patient plate must be placed on a well- vascularized muscle as next as possible to surgical area. Avoid connecting the patient plate to bony protrusions, prosthesis, cicatricial tissues, and parts of the body subjected to liquid accumulation or that present subcutaneous adipose tissue. The part of the body must be without hair, dry and clean. Do not use alcohol to clean the skin. Unless for veterinary use, the use of gelatinoids substances for the electrodes is not advised. By using the disposable neutral electrodes respect the date of expire. By using the reusable electrodes ascertain that the fixing systems give warranty of stability. When you apply the neutral electrode avoid the transversal course and prefer the vertical or diagonal course, in particular if a split neutral electrode is used. That to allow a uniform distribution of the current on the surface of the neutral electrode and reduce the risk of burn to the patient.
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Instruction’s Manual
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EN-15 MA362c_EN
EN-16 Instruction’s Manual MA362c_EN
If it isn’t possible to use correctly the neutral electrode, consider, if it’s possible, the bipolar technique instead of the monopolar one. The patient does not must be in contact with metal parts that are connected to the earth or have a large electrical coupling capacity to the earth (for example: operating-table or metallic support). The use of antistatic sheets is advised. Avoid the skin to skin contact (for example between arm and body of the patient). Insert an interface material like dry surgical gauze. Moreover, the parts of the body subjected to abundant perspiration must be maintained dry.
(1) Treatment area
(1) Active electrode - (2) Neutral Electrode (3) Dry gauze - (4) Antistatic cloth
When high frequency electrosurgical unit and physiological monitoring devices are used at a time in the same patient, all the monitoring electrodes, that have not resistive or inductive elements tested in high frequency interference environment, must be as far as possible from the electrodes of the electrosurgical unit. Avoid the use of monitoring needles. The connection to the electrodes should be located in such a way to avoid the contact both with the patient and with other cables. For surgical procedures where the HF current could flow through parts of the body having a relatively small cross-sectional area; the use of bipolar techniques may be desiderable in order to avoid unwanted coagulation. The power level should be the lowest useful to the work to do. Always check the return plate whenever electrosurgical unit fails to produce the desired effect. Reason for a low output power level, or for an incorrect functioning of the electrosurgical unit when arranged for a normal output, may be lack of connection of the return plate or its imperfect placement.
SURTRON 80 – 120 - 160 LED SpA
The use of flammable anesthetics, of oxygen and of nitrogen protoxide should be avoided in the case of operation at the head or at chest level except the possibility of evacuating gas. Flammable materials used to clean, or to disinfect, should be let to evaporate before the use of the electrosurgical unit. There is risk of stagnation of flammable solutions under the patient or in body cavities as the umbilicus and the vagina. The fluid that deposits in these areas should be removed before the equipment use. The danger of endogenous gas ignition has to be considered. Some materials like cotton wool or gauze, when saturated with oxygen, may burst into flames because of the sparks produced by the equipment in the normal use. There is a risk for the patients fitted with heart pacemaker or other stimulation electrode: interference may occur with the stimulator signal or the stimulator itself can be damaged. Please refer to Cardiology Unit when in doubt. Electrosurgical equipment does emit unnoticed radiation of high frequency energy that may effect other medical equipment, unrelated electronics, telecommunications, and navigational systems. The accessory must be regularly checked, particularly the cables for the electrodes and the possible accessories for the endoscopy to verify that the insulation is not damaged. To avoid the connection of incompatible accessories to the unit, the insulation characteristics of the items to be replaced must be requested to the manufacturer and compared to those of the supplied unit (see Technical Characteristics)). Attention: a damage of the electrosurgical unit could result in an unwanted increase of the output power. Inadvertent stimulation of a patient's muscle and nerves can be caused by low frequency currents originating in electric sparks between electrode and tissue of the patient. Should neuromuscular stimulation occur stop surgery and check all connections to generator. If this does not solve the problem, qualified service personnel must inspect generator.
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Instruction’s Manual
Manuale d’Istruzioni
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EN-17 MA362c_EN
EN-18 Instruction’s Manual MA362c_EN
Installation
The electric safety is insured only when the same are correctly connected to an efficient net linked to the earth in conformity with the actual safety requirements. It is necessary to verify this fundamental safety requisite and, in case of doubt, to require an accurate control of the plant from part of qualified personnel. The manufacturer cannot be considered responsible for possible damages caused from the lack of efficient connection to earth of the installation. Operation without a protective earth connection is forbidden. Before connect the equipment ascertain that the required voltage (showed on the rear panel) corresponds to the available mains. In case of incompatibility between the available wall socket and the feeding cable of the equipment, replace only with legally approved connectors and accessory items. The use of adapters, multiple connections or cable extensions is not advised. Should their use become necessary it is mandatory to use only simple or multiple adapter conforming to the actual safety requirements. Don't let the apparatus exposed to atmospheric agents. The unit must be protected from seepage of liquids. Don't obstruct openings or cracks of ventilation or heathsink Don't leave the equipment uselessly inserted. Switch off the equipment when not in use. The use of the unit is not suited in explosive rooms. SURTRON® must be destined only to the use for that have been expressly designed. Any other use is to be considered improper and dangerous. The manufacturer can not be considered responsible for possible damages due to improper, wrong and unreasonable uses. It is dangerous to modify or try modifying the characteristic of the equipment. Before effect any operation of cleaning or maintenance, disconnect the apparatus from the electric net, either unplugging it from the mains or switching off the mains switch of the plant. In case failure and/or bad operation of equipment switch off it. For the possible reparation address only to an authorized service centre and ask for the use of original spare parts. The lack to follow the above requirements could risk the safety of the equipment and can be dangerous for the user.
SURTRON 80 – 120 - 160 LED SpA
Do not reduce or disable the audible signal warning the activation of the generator. A functioning activation signal can minimize or prevent patient or staff injury in the event of accidental activation. Avoid verifying the functioning of the unit by shorting the active electrode with the reference one or the active electrode with metallic parts. If necessary use a smoke-plume extraction system.
WARNING: When the electrosurgical unit is used in operating rooms it is necessary to just use waterproof foot-switches (REF 00304.00 Water-proof pedal with single switch – REF 00304.03 Water-proof pedal with double switches)
Safety for the Patient During the HF electrosurgical operations the patient is a conductor of electrical voltage against earth potential. So if there is a contact between patient and electrical conductive objects (metal, wet clothes,etc..), in the contact’s point could be electrical current that causes thermical necrosis. So it is recommended to inspect the equipment and its accessories before using and to respect all safety rules.
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Instruction’s Manual
Manuale d’Istruzioni
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ITALIANO
EN-19 MA362c_EN