Touch: Manual de Usuario Y Servicio
Touch: Manual de Usuario Y Servicio
300
MA497EN
Instruction’s Manual
ENGLISH
SURTRON TOUCH 200
MA497b_EN
LED SpA
Summary
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Instruction’s Manual
MA497b
SURTRON TOUCH 200
MA497b
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
No part of this document could be photocopied, reproduced or translated in other language without the written consent of LED SpA. All right
reserved.
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Instruction’s Manual
MA497b
INTRODUCTION
Destination of Use / Sectors of Application
The use of HF electro surgical equipment SURTRON® TOUCH 200 has reserved to specialized medical personnel. The
equipment has destined to a temporary use, for surgical operations in emergency room or hospital. It has foreseen its
use in the monopolar cut, cut coagulated or coagulation mode or in bipolar cut or coagulation mode. The equipment is
conceived for being used in the following sectors:
= Recommended = Usable
SURTRON TOUCH 200
MA497b
LED SpA
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Instruction’s Manual
MA497b
SURTRON® TOUCH
Code Description
200
152 190 13 ELECTRODE Loop electrode 20x13 l.15 cm
152 190 20 ELECTRODE Loop electrode 20x20 l.15 cm
152 195 ELECTRODE Conization electrode 13 cm
310 110 05 BIPOLAR Bipolar Forceps 11,5cm TIP0.5mm
310 112 05 BIPOLAR Bipolar Forceps Curved 11,5cm TIP0.5mm
310 140 10 BIPOLAR Bipolar Forceps 20cm TIP 1mm
310 140 20 BIPOLAR Bipolar Forceps 20cm TIP 2mm
310 142 10 BIPOLAR Bipolar Forceps Curved 20cm TIP 1mm
310 142 20 BIPOLAR Bipolar Forceps Curved 20cm TIP 2mm
310 180 10 BIPOLAR Bipolar Forceps Angled 20cm TIP 1mm
310 180 20 BIPOLAR Bipolar Forceps Angled 20cm TIP 2mm
310 182 10 BIPOLAR Bipolar Forceps Angled Curved 20cm TIP 1mm
310 185 10 BIPOLAR Bipolar Forceps Angled Curved 20cm TIP 1mm
310 510 BIPOLAR Bipolar electrode 20cm – direct
310 550 BIPOLAR Bipolar electrode 20cm – curved
310 590 BIPOLAR Bipolar electrode 20cm – curved 2
330 134 20 MONOPOLAR Monopolar Forceps 20cm TIP2mm
330 160 MONOPOLAR Monopolar Surgical Scissors 18cm
500500.L1 ELECTRODE Straight thin wire electrode (5pcs) 5cm
500500.L1/L ELECTRODE Straight thin wire electrode (5pcs) 10cm
500500.L10 ELECTRODE Bent ball electro 3mm (5pcs) 5cm
500500.L10/L ELECTRODE Bent ball electro 3mm (5pcs) 10cm
500500.L11 Needles for micro surgery (10Pcs)
500500.L2 ELECTRODE Bent thin wire electrode (5pcs) 5cm
500500.L2/L ELECTRODE Bent thin wire electrode (5pcs) 10cm
500500.L3 ELECTRODE Loop electrode 4mm (5pcs) 5cm
500500.L3/L ELECTRODE Loop electrode 4mm (5pcs) 10cm
500500.L4 ELECTRODE Loop electrode 8mm (5pcs) 5cm
500500.L4/L ELECTRODE Loop electrode 8mm (5pcs) 10cm
500500.L5 ELECTRODE Bent hook electrode (5pcs) 5cm
500500.L5/L ELECTRODE Bent hook electrode (5pcs) 10cm
500500.L6 ELECTRODE Bent thick wire electrode (5pcs) 5cm
500500.L6/L ELECTRODE Bent thick wire electrode (5pcs) 10cm
500500.L7 ELECTRODE Drop electrode (L7) (5pcs) 5 cm
500500.L7/L ELECTRODE Drop electrode (L7) (5pcs) 10cm
500500.L8 ELECTRODE Noose electrode (L8) (5pcs) 5 cm
500500.L8/L ELECTRODE Noose electrode (L8) (5pcs) 10cm
500500.L9 ELECTRODE Straight ball electrode 3mm (5pcs) 5cm
500500.L9/L ELECTRODE Straight ball electrode 3mm (5pcs) 10cm
6429A NEUTRAL Steel Neutral Electrode 24x16cm
755VL Disposable handle with finger switches (F4797)
F7520 Electrode cleaning sponge 47x50mm
F7915 Conductive rubber neutral electrode without cable
F7930 Conductive rubber split neutral electrode without cable
TR003 Trolley 3 shelves
TR003W Trolley 3 shelves wide
TR004 Trolley 4 shelves
TR005 Trolley 5 shelves
TR005W Trolley 3 shelves wide
/ Pcs= STANDARD = OPTIONAL
General Description
SURTRON® TOUCH 200 is a electro surgical equipment suited to deliver current for cut, coagulated cut and
coagulation (with different levels of coagulation) in monopolar modality and cut and coagulation in bipolar modality,
with the bipolar coagulation modality can be activated a detection system of the tissues impedance with automatic
activation and automatic stop when the coagulation is achieved (AUTOSTART – AUTOSTOP). Moreover using the
specific function is possible to execute the synthesis and the vascular and venous coagulation through radiofrequency
clamping (vessel sealing).
The current can be delivered for the whole time of activation of the output circuit or for an interval of time which can
be preset.
The preset time delivery can be single, every time that the circuit of exit is activated, or repeated to in operation
intervals of the performed planning.
A total of eighteen different modes of use and levels of power, can be recalled for the use simply (preset program). It’s
possible to modification of this ore memorize other more Custom programs (over 50).
It is possible to use either single plate neutral reference electrodes or electrodes with split conductive zone so to
watch the stability of the plate to patient impedance during the surgical intervention.
Control of the units is via front panel touch keys and display; mains inlet is located on the rear panel.
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 selected parameters are recalled.
The level of the emission sound can vary; every operator can choose his own level according to the environmental
conditions of working.
The units can work either through holder handles with or without pushbuttons with double foot switch command.
It’s possible to connect bipolar forceps to the unit for the bipolar functions.
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Instruction’s Manual
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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
The thermical effect influence (Joule Effect) is made by:
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 Metals
(range from 0,3 to 1 MHz)
Blood 0,16 x 103 Silver 0,16 x 10 5
Muscle, kidney, heart 0,2 x 103 Branch 0,17 x 10 5
Liver 0,3 x 103 Gold 0,22 x 10 5
Brain 0,7 x 103 Aluminum 0,29 x 10 5
Lung 1,0 x 103
Fat 3,3 x 103
(Example of specific resistances of organic and metallic materials)
SURTRON TOUCH 200
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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).
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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Instruction’s Manual
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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
When there is a temperature increment, for the heat produced for Joule effect in the tissue, it’s realized the thermical
coagulation and that is the partial solidification of the liquids and so the precipitation of colloidal substances. In
particular fibrin forms in the blood and it, solidifying itself, obstructs the blood vessels.
To obtain the coagulation by the electrosurgical needle it needs to supply the active electrode with intermittent
current so that the water goes out from the cell without destroying it. However also with the intermittent current, if
the intensity of the current is too intense, the cut effect is realized.
Active electrodes particularly adapted for the coagulation are the electrodes with sphere shape, plate, or lanceolate
used laterally.
The coagulation can be obtained by two different methods: by desiccation and fulguration.
SURTRON TOUCH 200
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LED SpA
Coagulation by desiccation
It’s obtained supplying the electrode by low voltages that not generate sparks (this guarantees that the action is pure
coagulum and so every effects of the cut is absent). The electrode is placed in direct contact with the tissue and the
quantity of heat developed desiccates it.
Generally the coagulated cellular surfaces act like an insulation layer, that prevents that the heat had to the successive
applications of the current penetrates too much in depth.
The current normally used for the coagulation is the modulated type. In function of the percentage of the modulation
is realized the precision of the cut, the goodness of the haemostasis and the level of the tissue destruction. A bigger
modulation of the current gives a cut more irregular, and a bigger depth of tissue destroyed but a better coagulation.
The following rules help the operator to obtain a good coagulation:
select a ball electrode or a large wire;
localize the vessel bleeding after have been dried the exceeding blood from the area;
touch lightly the vessel bleeding before to activate the electrode;
stop the activation of the electrode when the tissue whiten to prevent to damage it;
maintain clean the point of the electrode(for this scope it’s advisable to use (for this scope it’s advisable using the
electrode cleaning sponges F7520).
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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 TOUCH 200
MA497b
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. With steel neutral electode, unless for veterinary
use, the use of gelatinoids substances for the electrodes is not advised. With conductive rubber neutral electrode
use conductive gel.
By using the disposable neutral electrodes respect the date of expire.
By using the reusable electrodes (steel or rubber) 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.
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.
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.
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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.
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.
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.
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.
(CORRECT application)
(WRONG application)
Before to apply the neutral electrode, clean and eliminate any external substances from its surface.
Do not apply the neutral electrode on cicatrix, bony protrusion or near prosthesis or monitoring electrodes. But apply
it on sprinkled tissues, such as muscles and near the operative site. If you use a disposable neutral electrode respect
the date of use, if you use a not disposable neutral electrode make sure that the fixing systems guarantee stability.
It is very important that the neutral electrode is firmly applied on its entire surface to avoid burns. When the neutral
electrode is partially taken off from the patient, the current density on the remaining applied part is higher. Because
the density of the current flow under the neutral electrode is not uniform, it verifies a not uniform heating, especially
near the borders of the neutral electrode.
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HF Electrosurgical in Laparoscopy
Since its introduction minimally invasive surgery has revolutionized surgical operation offering any significant benefits
to the patient of faster healing and less postoperative pain. In laparoscopy the monopolar HF electro surgery is the
most used because it is highly versatile (pure cut, coagulation, blended cut that combines these two functions), but
this modality can compromise patient safety by burns.
The constricted view of the surgical field, the poor maintenance of the laparoscopic instrumentation, interference on
the video monitor, the insufficient training of the surgeon or his inattention, the smoke, the insulation failure, the
capacitive currents, the contact of the tip of the active electrode with the surrounding tissue, these are all factors that
increase the hazard of burns, intra abdomen lesions, necrosis of the tissue, perforation of internal organs. The nature
of the surgical environment – in which the active electrode is in close proximity to other conductive instruments and
to tissue may make the electrical currents transmission to unseen tissue off the laparoscope, causing unintentional
tissue burns at non targeted sites, by:
- direct coupling
- insulation failure
- capacitive coupling
Direct coupling occurs when the active electrode touches another metal instrument, transferring electrical current to
it and possibly injuring tissue with which it comes in contact (for example bowel or other organs).
Insulation failure occurs when there is an excessive voltage, abuse, wear and tear, poor handling, or mechanical
accident of the electrode shaft that happens during a single laparoscopic procedure or during disinfection and
sterilization procedures. The breakdown along the unseen shaft of an activated electrode can allow electrical current
to leak into surrounding non targeted tissues, causing unobserved damage. Paradoxically, small cracks are more
dangerous than large breaks because the current is more focused, and is therefore more likely to produce burns.
Capacitive coupling occurs when electrical current is induced from the active electrode to nearby conductive material,
despite intact insulation. During HF electrosurgical operations the rapidly varying electrical field around the active
electrode is only partially impeded by electrical insulation and creates stray electrical currents by alternately attracting
and repelling ions in surrounding body tissue. Currents transferred in this way in nearby tissue can cause irreversible
damage. The movement of electrically charged ions in capacitive coupled tissue can cause currents that can heat
tissue sufficiently to produce burns.
Several measures are used during electrosurgical operations to limit and minimize the risks of patient injury:
- a better and more complete training for the medical staff;
- visual examination of the surgical instrumentation (active electrode, laparoscope);
- use of disposable electrodes (but the thinner insulation doesn’t reduce the risk of breakdown or capacitive
coupling);
- prohibiting the use of hybrid (plastic metal) cannulas;
- adopting bipolar electro surgery (not versatile, but safer, because the necrosis happen only if there is a long
and continuous application of the current).
In the HF electro surgery burns are a real hazard that can be minimized by the knowledge of the causes and especially
if the surgeon is prepared against these.
SURTRON TOUCH 200
MA497b
LED SpA
INSTALLATION
Inspect the unit for damages during transport. The claims for possible damages will be accepted only in case they
are immediately communicated to the carrier; the damages that are found must be written down and presented
to LED SpA or to your own retailer. If the unit is returned to the LED SpA or to your own retailer, it is necessary to
use the original equipment’s package or another equivalent one, to guarantee the safety during the transport.
Unpack the equipment and carefully study the documentation and operating instruction supplied. Mains voltage,
indicated above the label data, must agree with the local mains voltage (mains voltage frequency: 50 60 Hz).
Connect mains cable to a mains outlet having good hearth connection.
OPERATION OF THE EQUIPMENT WITHOUT EARTH CONNECTION IS FORBIDDEN.
The unit must be installed on a level surface, with dimension, at least, correspondent to those of the base of the
unit itself. Around the unit must be left a space of 25cm, at least.
Connect the mains cable to the mains socket on the rear panel of the unit.
Connect, if request, the equipotential binding post located at the left of the unit’s back panel to eventual
equipotential socket of the plant.
Connect the single foot switch or the double foot switch (optional)to the connector on the frontal panel of the
unit.
Connect handle to the corresponding connector and in the case of use of handle without push buttons it shall be
connected on the “ACTIVE” buckle.
Let unit work in dry environment only. Any verified condensate must be let evaporate before putting in operation
the unit. Don't exceed the temperature environment or the allowed moisture.
Environments condition:
WORK TRANSIT/STORAGE
Temperature: 10/40°C 10/+50 °C
Relative moisture: 30/75% 10 100 %
Pressure: 70/106k Pa 50/106 kPa
When the unit is switched on, through the on/off switch on the rear panel, it will work with the function and the
power level utilized during the last switching.
In monopolar mode before using the unit, it is necessary connect the cable to the patient plate. When split plate
electrodes are used it is necessary to close circuit. In this way, if the value of the impedance is acceptable, the
indicator light on neutral connector will stop flashing.
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1
1 Cable for bipolar accessories connection
2 Bipolar accessory (ex: bipolar forceps)
For the synthesis and the vascular and venous coagulation (Vessel Sealing):
3
4
Technical Data
FREQUENCY: 360kHz
Output CUT (CUT): 200W 300
Output ENHANCED CUT (CUT): 150W 300
Output BLEND (CUT /COAG): 150W 300
Output FORCED (COAG): 150W 200
Output SOFT (COAG): 100W 200
Output FULGURATION( COAG) 100W 1000
Output BIPOLAR PURE (CUT) 120W 50
Output BIPOLAR TUR (CUT) 120W 50
Output BIPOLAR COAG (COAG) 100W 50
Output BIPOLAR SEALING (COAG) 200W 50
1 2 3 4 5 6 7 8 9
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Frontal Panel
1. USB port
2. Display touchscreen (work screen)
3. Monopolar output connection
4. Connector for neutral electrode connection
5. Bipolar output connection
6. Foot switch connection
1. USB PORT
For software updating on the front unit is present one USB 2.0 port. See Update chapter.
2. DISPLAY TOUCHSCREEN
Display LCD touchscreen permits the visualization and controls of all the built parameters in a determinate procedure.
Operation Mode
When switched on the electrosurgical unit on the screen the initial shielded one appears that filler of the load of the
installed software. After HOME screen appears:
In this HOME screen it is possible to choose and work with: Programs, Surgery, change the Settings of work or Update
software through USB port.
Programs
Chose programs in the screen appears preset or, through Custom page, personalized program. Through help is
possible see characteristics of relative program. Touch back to return on Home page.
Through relative symbol (three line) Custom program can be: renominated (Aa) – modified (gear) – deleted
(dumpster)
To create a Custom program see work screen (Surgery).
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Instruction’s Manual
MA497b
Surgery
Touch icon with number for output regulation power, see example:
Touch icon with pedal for choose which is activated, see example:
In the section FLASH TIME, it is possible if select “timed” to set the number of repetition (repeat) of the impulses and
their duration (time).
The duration of the impulses is indicated in the icon, for change it touch and regulate.
The equipment can be set to obtain the power supply during all the time of activation of the output circuit (indication
continue) or for the power supply in a programmed time from 10 milliseconds to 30 seconds.
For the setting of the time follow the table below:
Supply Time
RF TIME Step
From To
10÷90 mSec 10 mSec 90 mSec 10 mSec
0.1÷0.9 Sec 0.1 Sec 0.9 Sec 0.1 Sec
1.0÷30 Sec 1 Sec 9.5 Sec 0.5 Sec
NOTE: To not use the temporized function (to obtain the supply during the activation time of the output circuit) set on
RF TIME, the indication continous.
The function RF time can be settled with all the functions, but do not interfere on the function
AUTOSTART/AUTOSTOP in BIPOLAR modality.
The interval of the repetition of the impulses is indicated by the icon repeat:
The supply with the programmed duration of the impulses can be repeated, as long as the output circuit would be
maintained active, for a presetting number of times (from continuos to 30 time). The interval from one repetition to
another one is from value 1 equal to the double of the duration of the impulse.
NOTE: Setting the value 1 there will be only one impulse. Setting the value 00 there will be a cycle of repetition of the
impulses during all the time of activation of the output circuit.
PROGRAM SECTION
To memorize the parameters in Custom Program press Save, in the next screen is possible named it.
To recall a Custom or a Preset Program press programs, in the next screen is possible choose it (see Programs).
Name of Preset or Custom Program is visible in the screen.
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Instruction’s Manual
MA497b
The neutral electrode's circuit is continually watched by a special circuit that prevents danger of burns to the patient
due the loss of contact between the reference plate and the patient skin. The circuit is also watched to avoid that the
variation of the characteristics of conductibility of the plate can provoke reduction of conductibility of the circuit, and
therefore danger of burns to the patient.
In order to reduce the acoustic pollution, the sound alarm is present only when pressed the foot switch.
If a single plate electrodes use watched only the connection of the neutral electrode plate to the unit.
If the impedance value is accepted, the impedance indication is recognized and the display allarm indicator on
electrode neutral connector are extinguished.
LIGHTS
In delivery state on the screen appear the function with the relative level, this screen remain for few seconds, in this
time you can adjust, by + and , the output level, for close screen press X.
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Instruction’s Manual
MA497b
Settings
From HOME choosing the option “settings” and the successive screen it is possible change: Language, Display
(luminosity and touch sensitivity), Volume, black or white display, setup of response of surgery delay start and Fast
medium slow autostart autostop. Touch icon to return on Home page.
SURTRON TOUCH 200
MA497b
LED SpA
Update
From HOME choosing the option “update” and the successive screen it is possible updater: Software, Images,
Protocols and firmware. Touch back to return on Home page.
To connect in the USB connector compatible device containing the compatible file of the software or images or
protocols or firmware to update.
Select “Software” or “images” or “protocols” or “firmware” and the successive popup confirming this. Follow show
instructions.
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Instruction’s Manual
MA497b
Monopolar
The supplying currents in the monopolar way for cut, coagulated cut and coagulation can be predisposed by the icon
keys present in the MONOPOLAR section. The power level for every function can be predisposed by + and level of
CUT , and COAG sections. The set power levels remain in the memory.
CUT COAGULATION
1 Cut 4 Forced Coag
2 Blend 5 Soft Coag
3 Enhanced Cut 6 Fulguration
Note: For use foot switch, press relative key and view monopolar foot switch symbol. See examples:
The description of the supplying currents is in the next paragraphes, according to the predisposition order of the
selection icon keys, in the MONOPOLAR section.
Bipolar
The distributable currents in the bipolar modality for coagulation can be selected by the icon keys of the BIPOLAR
section. The power level for every function can be selected by + and level of Bipolar sections. The power levels
selected remains in memory.
CUT COAGULATION
1 Bipolar Cut 3 Bipolar Coag
2 Bipolar TUR 4 Bipolar Vessel Sealing
Note: Use foot switch, press relative key and view bipolar foot switch symbol. See examples:
Using BIPOLAR function it will need to connect the bipolar accessories to the connector for this function (BIPOLAR)
and to use the foot switch.
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Instruction’s Manual
MA497b
Vessel Sealing
Function type suitable for the synthesis and the coagulation vessel arterial and venous clamping by
means of radio frequency.
The procedure is as follows: select a level suitable to the connected accessory and to the treatment to
be performed; Gently clamp the vessel with slight pressure; no auto start hitchhiking or press the pedal
and hold it down for the entire procedure; during coagulation, press lightly with pliers; clotting occurred in the pedal
may be released.
In the ‘Bipolar’ function can be choose four settings for bipolar coagulations:
No automatism for the distribution. The distribution is realized by pressing the foot switch and stops by
leaving again the foot switch;
START. The distribution is started, by pressing the foot switch, if there is contact between active electrode
1)
and tissue, and it stops by leaving again the foot switch;
STOP. The distribution is started, by pressing the foot switch, (if also there isn’t a contact between tissue and
active electrode) and stops itself when the tissue is coagulated . So by pressing the foot switch, if there is an
impedance value too higher, the distribution doesn’t start.
AUTOSTART/AUTOSTOP. The distribution starts, by pressing the foot switch, if there is a contact between
tissue and active electrode and stops when the tissue is coagulated. So by pressing the foot switch, if there is
an impedance value too higher, the distribution doesn’t start
SURTRON TOUCH 200
MA497b
LED SpA
Back Panel
WARNING: before switch on the unit, operator has to verify that requested mains voltage corresponds to the voltage
available from the electrical net. (see chapter INSTALLATION).
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Instruction’s Manual
MA497b
TECHNICAL CHARACTERISTICS
SURTRON®
Tollerance Description
TOUCH 200
Electrosurgical unit code 10100.T40
Detection system of tissue impedance (Bipolar coagulation – auto start/autostop)
Bipolar coag with automatic activation/disactivation
Minimum preselectable power 1
Selection of the power through touch screen
± 20% Maximum output power CUT (W) 200W 300
± 20% Maximum output power BLEND (W) 150W 200
± 20% Maximum output power ENHANCED (W) 150W 300
± 20% Maximum output power FORCED COAG (W) 150W 200
± 20% Maximum output power SOFT COAG (W) 100W 200
± 20% Maximum output power FULGURATION (W) 100W 1000
± 20% Maximum output bipolar power BIPOLAR CUT (W) 120W 50
± 20% Maximum output bipolar power BIPOLAR TUR (W) 200W 50
± 20% Maximum output bipolar power BIPOLAR COAG (W) 120W 50
± 20% Maximum output bipolar power BIPOLAR VESSEL SEALING (W) 200W 50
± 5% Modulation factor BLEND (Hz) 50
± 5% Modulation factor ENHANCED (Hz) 1.25
± 5% Modulation factor FORCED COAG (kHz) 20
± 5% Modulation factor FULGURATION (kHz) 20
± 5% Modulation factor BIPOLAR TUR (Hz) 50
± 0.2 Crest Factor CUT 1.6
± 0.2 Crest Factor BLEND 2.0
± 0.2 Crest Factor ENHANCED CUT 2.5
± 0.2 Crest Factor FORCED COAG 3.0
± 0.2 Crest Factor SOFT COAG 1.6
± 0.2 Crest Factor FULGURATION 4.0
± 0.2 Crest Factor BIPOLAR CUT 1.6
± 0.2 Crest Factor BIPOLAR TUR 2.0
± 0.2 Crest Factor BIPOLAR COAG 1.6
± 0.2 Crest Factor BIPOLAR VESSEL SEALING 1.6
± 10% Working frequency 360 kHz
± 15% Maximum output voltage CUT (Vpp) 2000
± 15% Maximum output voltage BLEND (Vpp) 1800
± 15% Maximum output voltage ENHANCED CUT (Vpp) 1800
± 15% Maximum output voltage FORCED COAG (Vpp) 2500
± 15% Maximum output voltage SOFT COAG (Vpp) 1000
± 15% Maximum output voltage FULGURATION (Vpp) 4000
± 15% Maximum output voltage BIPOLAR CUT (Vpp) 650
± 15% Maximum output voltage BIPOLAR TUR (Vpp) 1200
± 15% Maximum output voltage BIPOLAR COAG (Vpp) 650
± 15% Maximum output voltage BIPOLAR VESSEL SEALING (Vpp) 650
± 0.5 Size LxHxP mm 370x144x319
± 10 Weight (kg) 6
± 5% Selectable mains power (Vac) 100 – 240
± 1% Mains frequency (Hz) 50 60
±0 Fuses (5x20) TIMED 2xT 10AL, 250V
± 10% Electrical input power (VA) 750
± 10% Electrical input current (240Vac) (A) 3,15
± 10% Electrical input current (100Vac) (A) 7,5
Five steps adjustable sound level
Self check
Power accuracy output warning
Skin Plate Electronic Control1
1
Patient to plate contact monitoring system
SURTRON TOUCH 200
MA497b
LED SpA
SURTRON®
Tollerance Description
TOUCH 200
Split or not split patient plate allowed
Working (CUSTOM) condition storing2 Over 50
Electrical Class (EN60601 1) I CF
MDD 93/42/EC Class II b
EN55011 (CISPR 11) Class (Class/Group) 2/B
Patient circuit F
Duty Cycle (action / pause) in seconds 10 / 30
Output power control by foot switch or finger switch
Defibrillation proof
Equipotential binding
ABS cabinet
= PRESENT
2
Continuous storing of the last settings
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Instruction’s Manual
MA497b
MAINTENANCE
General
No user adjustable parts are within the equipment, either for calibration or service purposes.
The equipment housing must not be opened: the warranty is invalidated by any unauthorized entry into the unit. In
the event any repair or adjustment work being necessary, the whole equipment should be returned to the LED SpA.
Service Centre 04011 APRILIA (LT) ITALY, or to an other Authorized Centre, together with a description of the fault.
Maintenance work by the user is mainly the cleaning of the exterior of the cabinet, cleaning and sterilization of the
accessory items and checking of the equipment before each use. Carrying out function and safety check for
verification of the parameters is demanded to specialized technical people.
Repairs
High frequency cables and electrode holder handle cannot be repaired. Always substitute a damaged part with a new
one.
SURTRON TOUCH 200
MA497b
LED SpA
Fuses Substitution
Before substituting the fuse, disconnect the unit from the mains system
Only use fuse of the kind 5x20; they must have those characteristics: T10A (slow), proceed as follows:
(A B) Extract the fuse holder drawer from the power module.
(C) Insert the fuses.
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Instruction’s Manual
MA497b
DIAGRAMS
SURTRON® TOUCH 200
Diagrams of half and maximum output power versus impedance load Diagrams of half and maximum output power versus impedance load
100 2000 CUT100% 100 2000 BLEND
Diagrams of half and maximum output power versus impedance load Diagrams of half and maximum output power versus impedance load
100 2000 ENHANCED 100 2000 FORCED COAG
Diagrams of half and maximum output power versus impedance load Diagrams of half and maximum output power versus impedance load
100 2000 SOFT COAG 100 2000 FULGURATION
Diagrams of half and maximum output power versus impedance load Diagrams of half and maximum output power versus impedance load
10 1000 BIPOLAR CUT 10 1000 BIPOLAR TUR
SURTRON TOUCH 200
MA497b
LED SpA
Diagrams of half and maximum output power versus impedance load Diagrams of half and maximum output power versus impedance load
10 1000 BIPOLAR COAG 10 1000 BIPOLAR VESSEL
250 180
160
200 140
s)t 120
t 150
a re 100
W
( w
o 80
er 100 P
w 60
o
P 40
50
20
0 0
0 20 40 60 80 100 120 140 160 180 200 0 15 30 45 60 75 90 105 120 135 150
Setting Setting
Diagrams of output power versus nominal value Diagrams of output power versus nominal value
CUT100% BLEND
160 160
140 140
120 120
100 100
er er
w 80 w 80
o o
P 60 P 60
40 40
20 20
0 0
0 15 30 45 60 75 90 105 120 135 150 0 30 60 90 120 150
Setting Setting
Diagrams of output power versus nominal value Diagrams of output power versus nominal value
ENHANCED FORCED COAG
120 120
100 100
80 80
re re
w 60 w 60
o o
P P
40 40
20 20
0 0
0 10 20 30 40 50 60 70 80 90 100 0 20 40 60 80 100
Setting Setting
Diagrams of output power versus nominal value Diagrams of output power versus nominal value
SOFT COAG FULGURATION
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Instruction’s Manual
MA497b
140 250
120
200
100
re 80 re 150
w w
o 60 o
P P100
40
50
20
0 0
0 20 40 60 80 100 120 0 20 40 60 80 100 120 140 160 180 200
Setting Setting
Diagrams of output power versus nominal value Diagrams of output power versus nominal value
BIPOLAR CUT BIPOLAR TUR
140 250
120
200
100
150
er 80 er
w w
o 60 o
P P100
40
50
20
0 0
0 20 40 60 80 100 120 0 20 40 60 80 100 120 140 160 180 200
Setting Setting
Diagrams of output power versus nominal value Diagrams of output power versus nominal value
BIPOLAR COAG BIPOLAR VESSEL
100 500
0
0 10 20 30 40 50 60 70 80 90 100 0
0 20 40 60 80 100
Setting
Setting
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Instruction’s Manual
MA497b