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HFS95 100 Manuale E Rev08
HFS95 100 Manuale E Rev08
001
USER’S MANUAL Rev. 08 – Feb 2010
LIARRE S.r.l.
Establishment and Registered office:
Via G. di Vittorio, n°5
40020 Casalfiumanese (BO) – Italia
Tel. +39 / 542 / 667066 – Fax +39 / 542 / 668000
e-mail: info@liarre.it -- http://www.liarre.it
User's Manual
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MUB.001
USER’S MANUAL Rev. 08 – Feb 2010
LIARRE S.r.l.
Factory and Head Office:
Via G. di Vittorio, n° 5 – 40020 Casalfiumanese (BO) – Italy
Tel. +39 / 0542 / 667066 – Fax: +39 / 0542 / 668000
e-mail: info@liarre.it
internet:http://www.liarre.it
All information contained in this publication may be subject to modification for technical and commercial reasons
without prior notice.
Any necessary variations will be included in future editions of the manual.
This manual gives the necessary information for the high frequency electrosurgeries HFS 95 – HFS 100
installation and correct use. This is a fundamental reference book and guide for users, so it must be read carefully
before using the HFS, and kept nearby for quick reference. Even partial non-compliance with these instructions
could result in the unit's malfunction or damage, as well as injury to the user. The warranty will also be considered
null in this case. Therefore, the strict observance towards the producer’s instructions enables one to have the best
results from the equipment and if necessary receive rapid, efficient technical assistance.
Note
ATTENTION
This appears before certain operations which, if unobserved, may result in damage to the unit and/or its accessories.
WARNING
The warning notes indicate operations or situations which, if not known or carried out incorrectly, could
cause serious personal injury.
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Warranty
LIARRE guarantees all equipment for a period of 12 (twelve) months starting from the registration or sales date.
The warranty is valid provided that the equipment is used according to the instructions in the manual. For
warranty validity, it is also necessary to send the warranty coupon back to the manufacturer, along with a
photocopy of the sales receipt, within 8 (eight) days. If a product proves defective during warranty, LIARRE will
repair or replace it, at its own discretion.
This warranty will not be valid if the defect or damage is due to:
- User’s improper or inaccurate maintenance;
- Unauthorized opening of the external parts;
- Tampering, unauthorized modifications or incorrect use;
- Irregular functioning without respecting the product's environmental specifications;
- Use of non-original parts;
- Improper installation;
- Use of incorrect cleaning liquids;
- Use of non original packaging.
ATTENTION
Packing instructions:
- disconnect the power cord and separate the accessories;
- use the original carton and packing filler;
- enclose customer's comment or note specifying service needed, type of damage or malfunctioning or any
further information useful to the technician.
LIARRE S.R.L. remains at complete disposal of its customers for any information about its products.
LIARRE also grants a punctual and efficient assistance. LIARRE does not accept any responsibility for technical
operations made by non authorised personnel.
Many of the definitions and of the suggestions given in this manual are taken from the texts of the
harmonised norms EN 60601-1 (CEI 62-5), EN 60601-2-2 (CEI 62-11), concerning safety, the use and the
maintenance of the high frequency electrosurgeries. LIARRE high frequency electrosurgeries have been projected
and manufactured according to those norms.
Table of contents
CHAPTER 1 : INTRODUCTION PAGE 5
1.1 Historical background of high frequency surgery or RADIOSURGERY. PAGE 5
1.2 General information about HF units. PAGE 5
1.3 Nature of the dangers in HF surgical technique. PAGE 6
CHAPTER 2 : INSTALLATION OF THE UNIT PAGE 9
2.1 General features and working principle PAGE 9
of electrosurgeries HFS 95 and HFS 100.
2.2 Operation modes. PAGE 10
2.3 Basic information and general problems of HF surgery. PAGE 15
2.4 Clinical indications in dentistry. PAGE 16
CHAPTER 3 : DESCRIPTION OF THE CONTROL KNOBS AND BUTTONS, SIGNALS AND PAGE 17
CONNECTIONS
3.1 Front panel HFS 95. PAGE 17
3.2 Front panel HFS 100. PAGE 18
3.3 Back panel HFS 95 and HFS 100. PAGE 19
3.4 Sound signals of HFS 95 and HFS 100. PAGE 20
3.5 Graphic symbols on the panels of HFS 95 and HFS 100. PAGE 20
CHAPTER 4 : USE OF THE UNIT PAGE 21
4.1 Installing and using the electrosurgery HFS 95 and HFS 100. PAGE 21
4.2 Monitor circuit of neutral electrode PAGE 23
4.3 Particular precautions for use. PAGE 25
4.4 Maintenance after use. PAGE 25
4.5 Discharge after use and environment’s protection. PAGE 25
CHAPTER 5 : TECHNICAL FEATURES OF ELECTROSURGERIES HFS 95 AND HFS 100 PAGE 26
5.1 Electrosurgeries HFS 95 and HFS 100. PAG. 26
APPENDIX A PAGE 28
Graphic 1 HFS 95, HFS 100 output power according to the load. PAGE 28
Graphic 2 HFS 95, HFS 100 power setting in monopolar cut mode (load: 50 to 2000 ohm). PAGE 28
Graphic 3 HFS 95, HFS 100 power setting on a 1000 ohm load. PAGE 29
Graphic 4 HFS 95, HFS 100 power setting on a 200 ohm load. PAGE 29
ANNEX 1: EMC TABLES PAGE 30
Table 1 Emission aspects. PAGE 30
Table 2 Immunity aspects. PAGE 30
Table 3 RF immunity aspects. PAGE 31
Table 4 Reccomended separation distance between portable and mobile communication sets PAGE 31
and HFS 95 and HFS 100 electrosurgery units.
CONFORMITY DECLARATION PAGE 32
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Chapter 1
Introduction
1.1 – Historical background of HF SURGERY
The development of electrosurgery instruments and their specialized use in several fields of general
surgery basically derives from the evolution of the ancient cauterization techniques (from the Greek word
kauterion, a hot iron used for branding). Many doctors still use the word "thermocautery" or
"electrocautery" by mistake, when referring to HF surgical equipment, disregarding the remarkable
differences between the two. "Electrocautery" is the modern (electric) version of thermocautery, invented
by C. Paquelin in 1875; it used a resistive filament made white-hot by electric current flowing through it.
Cauterization (i.e. hot surgery) implies tissue removal and modification using white-hot devices
causing tissue burning. This results in local third-degree burns, with all resulting adverse effects on the
wound (irritations, difficult healing, tissue destruction, carbonization, tissue retraction etc.). Cauterization
is by no means similar to high-frequency surgery (also called radiosurgery, or HF electrosurgery), since
the latter is a "cold" technique: tissue is parted using high-frequency (HF) oscillations of suitable
amplitude. Hot surgery long survived before being totally replaced by electrosurgery. HF surgical
techniques has become successful as soon as it was understood that the use of frequencies higher than 0.5
Mhz caused no induced muscular contraction in the patients. These high-frequency currents could
therefore be used for both surgical and therapeutical purposes.
It was J. A. D'Arsonval with his experiments in 1891, who found out that the application to humans
of electric currents higher than 10 kHz in frequency, by considerably reducing the causes of
neuromuscular stimulation, could be successfully used for surgical purposes. While the first low-power
electrosurgery appliance (for dental applications) was developed in the United States in 1969. Since then,
the technology applied to this kind of equipment remarkably evolved, also thanks to the experience
acquired by doctors and manufacturers. As you will see, the HF surgical instruments manufactured by
LIARRE (HFS 95 and HFS 100), allow a total control of operation parameters, and represent the state of
the art in terms of surgery final quality, repeatability of operations, patient and operator safety.
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A few definitions are given herebelow referring to common words used in HF surgery:
ACTIVE ELECTRODE
electrode used in electrosurgery to produce physical effects on organic tissues such as cut and/or
coagulation, concentrating high HF energy density at tissue level.
NEUTRAL ELECTRODE
Relatively large-face electrode which is applied to the patient body and acts as the return circuit for
high-frequency current. The currents in the contact point between patient and neutral electrode are at
such a low level that there is no physical side effects like burns. The neutral electrode is also called
FLAT ELECTRODE, PATIENT PLATE, PASSIVE or DISPERSIVE ELECTRODE, RETURN
ELECTRODE or PATIENT ELECTRODE (GROUND PLATE).
BIPOLAR ELECTRODE
Assembly of two active electrodes on the same support, usual in the shape of a forceps, causing high-
frequency current to flow mostly between the two probes, while the instrument is working.
CUT (ELECTROTOMY)
dissection of biological tissues caused by the flow of high-frequency, high-density current (from the
active electrode), causing heat (temperatures exceeding100 °C) (instantaneous cell evaporation).
COAGULATION
Haemostasis of small vessels in the body tissue caused by the flow of high-frequency current causing
heat (temperatures not exceeding 100 °C).
APPLIED PART
all the applied parts, including the cables, which are put in contact with the patient for diagnostic or
therapeutical purposes. In the radio knife, the applied part include are the active, neutral and bipolar
electrodes and their cables.
1.3.1 – Burns
When a radio knife is used in the monopolar technique, it is implied that the physical effect only
takes place in the tip of the active electrode. The small surface of this electrode causes a very quick
increase in the body tissue temperature. The HF current flows through the patient to the neutral electrode,
or when the contact between this and the patient is not adequate, through any other alternative medium
offering low resistance to the HF currents. If the contact area where the current leaves the patient is not
large enough, the temperature of that area will considerably increase, resulting in a severe local burn.
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WARNING
The heat which develops from contact with the neutral electrode is usually dissipated by the
subcutaneous blood circulation: the resulting temperature is therefore kept low. However, in the higher
pressure points or after prolonged patient pressure on the neutral electrode, blood circulation may
become difficult and heat may not be properly dispersed. Furthermore, it should be born in mind that
skin and blood flow in the body tissues may be altered by body temperature, anaesthetics and drugs
used during surgery.
WARNING
Devascularised patients may develop lesions near the neutral electrodes, even if they are correctly
applied, due to similar mechanisms. Special care is needed in these cases.
OF THE ELECTROSURGERY.
ATTENTION
We recommend to check if there are electromagnetic interference problems
with other instruments near the electrosurgery when it is activated, and if there are,
try to reduce or eliminate the interference by taking away the electrosurgery
and its cables from the other instrument.
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CHAPTER 2
Installation of the unit
2.1 –General features and working principle of electrosurgeries
HFS 95 and HFS 100
The main working principle is the following: electric current oscillations having a frequency
exceeding 0.3 MHz (300,000 oscillations per second) can flow through organic tissues without causing
shock, muscular contractions and pain; on the contrary, they can generate considerable heat on the tissues.
Heat is generated by dissipation effect on the electric resistance offered by the tissue (Joule effect). High
frequency current is applied - in the monopolar technique - through a thin needle electrode (active
electrode) contained in a lightweight and handy handpiece. High density HF current (A/mm 2) is obtained
in this way in the chosen area only.
At the active electrode-to-tissue interface level, a certain amount of heat is developed (the heat rise
exceeding 100 °C), which causes instantaneous vaporization of the organic tissue layer rich of cell fluid,
while both the active electrode and the neutral electrode (or plate: it is used for return to the appliance of
the HF current supplied to the patient) will remain cold.
The frequency generally used for HF current is comprised between 0.4 and 3 MHz should be
chosen according to the average type of body tissue treated. LIARRE appliances HFS 95 and HFS 100
are optimized for minor and medium surgery precision applications, with quartz-controlled, 485 kHz
frequency (485,000 oscillations per second) HF emissions notwithstanding the operating mode, the
selected output power and the type of tissue be treated.
Frequency of the HF current oscillations
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This function perfectly replaces pure cut made with traditional knives. The waveform represented
by the HF current is sinusoidal and tipified by unmodulated amplitude and high spectrum purity, and is
totally free from overlapped modulations, which as is it known will cause unwanted coagulation effects,
by inducing higher lateral heat on the electrode.
Thanks to these features, the HF surgery technique offers a number of critical advantages with
respect to the traditional cutting technique. Using a radio knife having suitable characterostics turns out to
be simpler and more relaxing, while better results can be obtained in a shorter time and with reduced
bleeding.
A precise cut must be made by using a thin needle electrode, THE INSTRUMENT SHOULD BE
STARTED A MOMENT BEFORE MAKING CONTACT TO THE TISSUE. In order to make sure
you are working under the ideal conditions, always check that the electrode is clean and polished (use
emery): the electrode must slide on tissue with no applied pressure or resistance. If there is any resistance,
slightly increase the instrument HF power level. A good way to always keep the electrode clean is to rub
a piece of gauze soaked in methylated spirits and water in equal proportions on the electrode working
part, which is often clogged by tissue residues, blood and sometimes pus.
If the electrodes are dirty, an insulating crust of carbonized blood and tissue residues will form on
them: this insulating layer causes electric arcs and sparks, resulting in underlying tissue carbonization
(fulguration).
It is vital that cutting speed is not too high: this might damage the most sensitive tissues, cause
unwanted coagulation or even burn the tissue. Most of all, electrode sparking (fulguration) should be
avoided, because sparks would imply an increase in lateral heat resulting in unwanted coagulation effects.
The wound edge should not become white.
Each incision should be made while paying special attention to the electrode position with
respect to the tissue: the electrode should be kept in a vertical position, whenever this is possible, to
avoid unwanted coagulation. The best thing to do before cutting is to carefully clean the involved area
with water, then dry up leaving the area slightly wet.
Cut using (thin and thick) needle electrodes and loop electrodes, of the type used for tissue removal,
biopsies, levelling and plastic modelling. Cuts made with thick needle electrodes will increase lateral heat
on the wound, thus helping haemostasis. However, primary healing is not always guaranteed in this case.
Fine tuning of the power level (allowing cuts of different depth to be made on very different tissue
types) and instrument quality will enhance this feature, and place HFS 95 and HFS 100 at the top end of
the scale in terms of final performance in this operation mode, because the current emission is
characterized by the highest stability and spectrum purity.
It is a good thing not to stop too long in the same area with the electrode and the instrument
on: this is critical to avoid internal heat build-up. It is also advisable to perform longer operations in
following stages, with frequent pauses of a few seconds between one cut and the following one. It is
certainly possible to take the electrode back to a previously made cut, provided that you touch the cut
with the activated electrode and you make frequent pauses (time between electrode-to-tissue repeated
contacts should not be shorter than 10 seconds). After cutting, it is necessary to remove any residue which
might affect wound healing, using a 3-15% H2O2 solution.
Any cut made with HFS 95 and HFS 100 in the CUT operation mode can be easily sutured;
perfect healing is guaranteed.
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In this operation mode, the instrument will supply HF current in the most suitable waveform for
pure cut, with very low superficial coagulation and no tissue retraction or lateral heat. Incisions made
with these instruments will give much better results than those obtained with a traditional knife:
aesthetically superior outcomes can be obtained in a shorter time, because even awkward and delicate
areas can be treated without any effort.
CUT/COAG (cut and coagulation effect):
It corresponds to30% (low modulation index) amplitude-modulated, HF simple harmonic current.
In HFS 100 it is indicated by a yellow light.
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ATTENTION
In coagulation technique, opposite to cutting techniques, the electrode or the forceps MUST BE
PLACED ON THE TISSUE BEFORE THE INSTRUMENT IS TURNED ON
The radio knife activation time is a critical parameter, because it has a direct influence on
coagulation performance and final quality: this is particulaly clear in highly sensitive tissue applications
(e.g. ophthalmological, dental, aesthetic surgery, dermatological, ENT applications). HFS 100 instrument
is particularly indicated for these kinds of operation, because it allows timed activation of HF current
to be controlled each time the foot control is pressed, with highly accurate (quartz-controlled)
timing which can be programmed from 0.01 to 0.99 seconds. These features make it virtually
impossible to destroy tissue parts close to and below the superficially treated ones. The average activation
times are between 0.1 and 0.5 seconds.
One of the main advantages offered by HFS 95 and HFS 100 coagulation modes is the possibility to
control the HF output power in a highly accurate and repeatable way up to very low levels, when the
highest delicacy and accuracy are needed. In these cases, the only effect is a cell protein denaturation (due
to an induced temperature lower than 100 °C). This causes tissue congultination which in turn makes a
haemostatic effect. A too high power level would be difficult to control and it would result in a more
aggressive action, with tissue burning and carbonization effects. It should be observed that these
operation modes, if properly used, at a relatively low power level, allow micro-coagulations (suitable
electrodes should be used) smaller than 0.2 mm in diameter, which is well beyond the minimum clinical
use threshold.
The above notes clearly show the importance of having a HF surgery instrument. The radio
knives HFS 95 and HFS 100 are brand-new products presented by LIARRE in the fields of minor
precision surgery and of in- and out-patient medium surgery. They are sophisticated instruments,
absolutely necessary whenever highest safety, precision and operation repeatability are needed.
These high-tech, aesthetically refined, highly compact, top quality instruments fully meet the
demands of both unpractised doctors and specialists who wish to obtain the best outcomes when using HF
surgical techniques. These instruments are easy to use thanks to a control keyboard (fully digital in the
HFS 100 model). All the main parameters influencing surgical technique can be entered with the highest
precision:
1) continuous adjustment of HF output power (displayed in model HFS 100, knob-controlled in
model HFS 95);
2) patient-applied HF current envelope selection in 4 different operation modes, (digital and LED-
indicated in model HFS 100);
3) instrument start (indicated by a sound and a visual signal) can be controlled in normal mode (each
time the foot control is pressed), or in the timed automatic mode (selectable working times from
0.01 to 0.99 seconds - in model HFS 100 only) which avoids tissue necrotization, given the short
operating times;
4) automatic stabilization of the supplied HF current with respect to the type of tissue to be
treated: to obtain the highest effectiveness and patient safety, avoiding sudden increases; in applied
HF current density after treatment of a tissue area where conductivity is not even (severely inflamed
area);
5) internal auto-check function: instrument operation is automatically interrupted after approximately
6 seconds of continuous operation (largely sufficient for any uninterrupted electrosurgery operation):
the foot control must be pressed again. The instrument is automatically disconnected (intermittent
sound signal in model HFS 95, intermittent sound signal and visual indication, with display flashing,
in model HFS 100), in case of internal overheating. The instrument is automatically resets after the
overheating problem is solved.
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6) thin active electrode handpiece, handy and reliable, can be sterilized in autoclave (135 °C)
together with its special cable and electrodes.
WARNING
As already said, THE ONLY CONTRA-INDICATION FOR THE USE OF ELECTROSURGERIES IS REPRESENTED
BY CARDIAC STIMULATOR IMPLANT RECEIVERS.
Another frequently recurring issue in dentistry is the fear of producing bone damage with resulting
considerable postoperative pain. This may only happen if the doctor stops too long in the same tissue area
(near the bone) with an activated electrode. This will cause excessive; heat build-up in the bone, which
may lead to necrosis at worst and to postoperative pain at the best.
These problems can easily be avoided by using the HFS 100 instrument with preset timed mode
(maximum time 0.5 seconds): this activation time is more than sufficient for this kind of operation. If
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treatment of the same tissue area must be repeated, wait for 10 seconds before applying the electrode
again.
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Chapter 3
Description of the control knobs and buttons, signals and connections of
HFS 95 and HFS 100
3.1 – Front panel HFS 95
Front panel HFS 95
(1) (g) (4) (2) (f)
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CUT/COAG (cut mixed to coagulation): modulation at 30% (output power: 70% of the nominal power – 70
W on 1000 ohm),
COAG (monopolar coagulation and micro coagulation): modulation at 45% (output power: 55% of the
nominal power – 55 W on 1000 ohm),
COAG BIPOLAR (bipolar coagulation): modulation at 55% (output power: 45% of the nominal power – 45
W on 1000 ohm).
(4): Display indicatine the output power:
Relative indication from 01 (minimum level) to 99 (maximum level).
(5): Green led:
The unit is switched on acceso: output power on.
INDICATIONS:
(f): Indications and / or safety warning (see table og graphic symbols).
(g): Selected operation mode indicated by the relevant led (3).
(h): Activation time set in the timer (indication of the selectors (H)).
3.3 – Back panel of HFS 95 and HFS 100
Bacl panel HFS 95 ad HFS 100
(a) (β)
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Back panel;
front panel, next to the output Attention
connectors
Back panel Type BF
Front panel; Applied part type BF
front panel, next to the output
connectors
Front panel;
front panel, next to the output Electrodes isolated from round at high frequency (“floating” output
connectors circuit)
Front panel;
front panel, next to the output Non ionising radiations
connectors
Front panel;
front panel, next to the output Dangerous voltage
connectors
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CHAPTER 4
Use of the system
4.1 – Installation and use of the electrosurgeries HFS 95 and HFS 100
The installation of the high frequency electrosurgeries HFS 95 and HFS 100 is simple and quick
and there are only a few basic norms to be observed. The electrosurgery must be put is a convenient place
for the operator. The place must be dry, far from heat sources and well aerated. In order to grant a good
heat dissipation it is important not to put anything (such as cloths and materasses) between the machine
and the table and close to the air slots.
Connect the foot switch in its connector (see description of the back panel) on the back of the unit
and connect the cables of the active electrode (handpiece + electrode) and of the neutral electrode on their
connectors in the front panel. The neutral electrode,according to the application field (medical or
veterinary) is made of the cable and by a elecgtode for the connection to the patient. The neutral electrode
is different according to the application filed and to the customer's request. The neutral electrodes are the
following:
- square rubber ground plate ( a square of conductive rubber for the veterinary market)
- split single use ground plate (conductive plate with adhesive gel for medical use).
This kind of plate is is made by a unique body where there are n°2 conductors for the monitor of the
patient's connection to the neutral electrode.
- split reusable plate (square rubber ground plate made of conductive rubber with double conductor
for the monitor of the patient's connection).
The standard neutral electrode supplied with the unit is the single use split ground plate. This kind
of electrode is made by a split cable which must be connected to the electrosurgery by its 4 poles
connector and by the ground plate itself (also split) to be connected to the opposite end of the cable by the
forceps which is on the cable itself.
Make sure all the connectors are well tight.
Make sure the contact of the grund plate with the patient is perfect on its whole surface, in a wide
area of tissu, at a distance of at least 30 cm and in a position opposite to the operation point. The split
neutral electrodes are in conformity to the European norms about the manufacturing procedures of the
high frequency electrosurgeries.
This system allows to control constantly that the contact between the patient and the neutral
electrode (ground plate) which closes the power circuit, thus assuring a safe operation. If the contact
between the patient and the neutral electrode were bad one would risk, in extreme cases, to make a burn
on thye contact point of the active electrode. This system grants a high safety use, but it requires a very
accurate positioning of the ground plate in order to avoid to produce parassite currents which would cause
a alarm without a reason.
In almost all the cases of use, apart from operations on the back, the ideal application point of the
ground plate is the lower part of the back, just above the cluneals with the electrodes aligned to the spine.
This application point allows to operate on the head, harms and legs, torax without creating false alarms
because of parassite currents.
In case you have to operate on the back, the ideal application point is the abdomen, just abive the
navel.
If, for any reason, it is not possible to reach neither the back nor the abdomen, we suggest to put the
ground plate on a arm or on a leg not involved in the operation with the electrodes aligned to the limb
itself (see following picture).
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The limb with the ground plate must not be too far from the operation point.
The application point of the ground plate must be clean and shaved.
In case of alarm of the neutral electrode (when you press the foot switch there is no output power,
Arto stilizzato
We underline that, for safety reasons the unit does not activate if the cable of the neutral
electrode is not connected, moreover the monitor circuit of the neutral electrode cuts off immediately in
case it detects a bad contact between the ground plate and the patient. In order toachieve this, you must
use a split ground plate.
The connection to the mains (220-230 Vac / 50-60 Hz) must be made exclusively by the supplied
cable, making sure the system has the ground connection (necessary for functional reasons). Do not use
extensions.
ATTENTION
During installation and use,
MAKE SURE THAT THE ACTIVE ELECTRODE CABLE AND THE NEUTRAL
ELECTRODE CABLE ARE NOT TOO CLOSE OR INTERTWINED:
THEIR PATHS FROM THE APPLIANCE TO THE POINT OF APPLICATION MUST BE
STRAIGHT AND CONVENIENTLY SPACED.
This helps to avoid useless power losses which would make the working parameters less certain and
less easily controllable
When the instrument is switched on by the switch on the back panel a green light (ON) turns on in
model HFS 95; in model HFS 100 the display power tuns on.
The HFS 100 device will automatically start in the working mode COAG BIPOLAR, which is
shown by a blue light; the timer will be off.
Note that the operating mode COAG BIPOLAR automatically cuts the active electrode
(handpiece) connector and the neutral electrode connector, activating the bipolar output for the
forceps (black bushings with the writing BIPOLAR OUT).
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To use the monopolar technique, it is enough to select any of the other operation modes: the
instrument will automatically switch the HF output current to the active electrode and neutral
electrode connectors (MONO OUT), and will cut the forceps connectors.
This is a very useful feature because it allows the cables and the relevant connectors to be always
safely kept connected to the appliance, for fast switching between two surgical techniques (monopolar
and bipolar).
It should be reminded that also in the bipolar technique, the appliance will not be activated
until at least the neutral electrode connector is plugged in. Therefore, if you only plan to use the
forceps to carry out bipolar coagulation, the neutral electrode should be plugged in anyway, even
though you will not use it.
The selection of the operation mode (CUT, CUT/COAG, COAG - COAG BIPOLAR) is made by a
special knob in model HFS 95, and with the MODE push-button in model HFS 100.
The adjustment of the HF output power is done, in model HFS 95, with the HF.POWER knob,
whose scale ranges between 1 and 10. In the digital model HFS 100 two push-buttons are used (+ and -
HF.POWER) to control the increase and decrease in the power level, which varies between 0 and 99.
NOTE
Display reading of the power level in model HFS 100 is of the relative type only, providing an
approximate idea of the HF output power (expressed in watts) in the CUT operating mode.
The curve showing the deviation betwen the display reading and the actual RMS power supplied by the
appliance is shown in annex 1.
In model HFS 95, the HF output power is of the relative type with a 10-level graduated knob.
In all the instruments, when the foot control is pressed (HF activation), an orange led switches on
(ACTIVATED) and a sound signal is operated (tones change according to operation modes), to indicate
the presence of HF current at the selected electrodes.
Independently of the TIMER function, the supply of HF current is automatically suspended after
approximately 6 seconds of continuous operation. To reset, press the pedal once more.
WARNING
Do not test the radio knife by starting the appliance with an empty handpiece, without a
connected active electrode cable, against conductive parts or in direct contact with the neutral
electrode.
These working conditions, with an instrument preset for high HF output power would cause high open
circuit voltages or high pilot currents, possibly affecting the radio knife short- and long-term
performance.
If you wish to obtain timed activation using HFS 100, it is enough to press the TIMER ON button
(the TIMER function will be indicated by a green light turning on) and program times (from 0.01 to 0.99
seconds) with the SET TIME two-digit selector (time increase and decrease is controlled by keys + and -).
The displayed numbers are hundredths of second.
Under these conditions, every time the foot control is pressed, the appliance supply HF current to
the output circuit exclusively during the programmed time.
In case of internal overheating due to hard working conditions, an automatic control (auto-check
function) is provided in all models to stop the HF energy supply. Its operatior indicated by an intermittent
alarm sound signal (in model HFS 100 the displays also be flashing).
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This is an additional protection feature which is only operated under extreme working conditions,
i.e. in case of instrument improper use or malfunction which would affect the instrument reliability.
It is a temporary and fully automatic protection: wait a few minutes until the alarm signal stops and
normal operating conditions are restored.
WARNING
The electrodes, connectors and cables should be handled with special care since they are the parts
in contact with the patient. In particular make sure that:
1) the neutral electrode is safely applied as close as possible to the operation area;
2) contact with the neutral electrode is very good throughout the operation;
3) high frequency wires, especially the neutral electrode ones, do not form spirals and are positioned in
such a way as not to make contact to other wires or to the patient. You should use only the cables
supplied with the appliance;
4) the HF current path within the patient is as short as possible. Take into account any metal prostheses
in/on the patient. Do not allow the HF current to flow near low-vascularit body parts or near parts
with minor muscle mass.
WARNING
If the patient is connected to the radio knife and to a monitoring device (e.g. an E.C monitor) at the
same time, the following directions must be observed:
the active electr should never be used near E.C.G. monitoring electrodes (minimum distance = 15
cm).
Do not use needle electrodes or injection tubes; make sure no metal parts (like the monitoring
device connectors) make contact to the skin.
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it may fool the monitor circuit that may see it as the patient body.
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The monitor is enabled when any monopolar output mode is selected (pure cut, cut/coag., coag.); it
is intentionally disabled when COAG BIPOLAR mode is selected, since there is not any neutral
electrode on a bipolar output.
As previously discussed, the monitor is able to detect a faulty condition only when the
electrosurgery unit is activated a minimum amount of HF current is flowing from the active
electrode through the patient body to the two halves of the neutral electrode; a faulty condition
is immediately detected and the output inhibited within less than two milliseconds: a too short time
to produce damages, even at the highest power setting.
If a faulty condition is detected the alarm starts by an intermittent beep and the power display flashing
(the latter only on HFS 100). Releasing the activation foot-pedal clears the alarm indication and
sets the electrosurgery unit in a ready to operate condition: the user must check the neutral
electrode connection to the patient, cables and connectors in order to detect and remove the
bad contact before attempting to continue the operation.
The monitor alarm indication described above is the same issued in case of overheating by the
temperature protection circuit; the difference being that overheating alarm holds while the
temperature stays over the protection threshold, whilst neutral electrode alarm stops at foot-pedal
release.
Electrosurgery activation when the neutral electrode is disconnected may or may not trigger the
monitor circuit, depending on capacitive couplings of the two halves of neutral circuit with
surrounding objects.
Electrosurgery activation when the neutral electrode is correctly applied to the patient body will not
trigger the monitor circuit.
4.3 – Special recommandations for use
Be very careful while you use a radio knife and follow the directions for use given below:
- the HF output power should be adjusted to the lowest possible value, compatibly with the
specific application;
NOTE: an insufficient output power, despite good instrument setting, may be caused by
insufficient contact of the neutral electrode or the connectors, by broken cables under the
insulation or by clogged electrodes. These causes of malfunction should be detected and
eliminated before the output power is brought to a higher value.
- After each patient positioning, the electrodes and cables should be checked.
4.4 – Maintenance after use
After using the radio knife, the following operations at least should be carried out. They should also
be carried out before use, especially if the instrument is not often used:
- make sure the outer casing is not visibly damaged;
- make sure all the instructions and symbols are readable;
- make sure the mains plug, the connectors, cables, active electrode handpiece insulated forceps -
if any - are not visibly damaged;
- make sure the neutral electrode is clean and in good condition.
4.5 – Discharge after use and environment’s protection
The product does not contain either piles or bacteries, but for its manufacturing it contains
some components which in some circumstances, if released in the environment, can
become potentially dangerous for people and for the environment itself.
Being an electronic device it has to be discharged with a separate collection.
It is up to the customer, if he/she thinks it is necessary, to apply to its dealer or distributor
to return the old device.
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We remind that the unauthorised discharge of the electric and electronic wastes will be fined according to
art. 13 comma 1 of D. Lgs. 25/07/2005 n° 151. Moreover it is fined by the local norms in force.
CHAPTER 5
Technical features of HF electrosurgeries HFS 95 and HFS 100
5.1 - Electrosurgeries HFS 95 and HFS 100
Classification: Medical devices classe IIb, patient applied parts type BF, conforming
to requisites of Directive 93/42/CEE, according to Harmonised
Norms EN 60601-1, EN 60601-2-2 ed EN 60601-1-2.
Electrical insulation: class II units (with functional earth connection).
Protection rating against liquids
and dust penetration: IP21 (according to EN 60529).
Mains supply: 230 Vac 50/60 Hz.
Mains absorbed power: 192 VA.
Mains fuses: 2 x 3.15 A fast 5x20 mm (line and neutral), reachable from the outside
on the back panel.
Output HF frequency: 485 kHz quartz controlled (± 100 ppm).
Case dimensions: 270 x 245 x 105 h mm
Weight: approx. 4.2 Kg
Control features:
FLOATING output circuit (type BF).
Monopolar and bipolar surgical techniques with separate outputs.
Four operating modes: CUT (monopolar pure cut), CUT/COAG (monopolar cut with
coagulus effect), COAG (monopolar coagulus), COAG BIPOLAR (bipolar coagulus).
Automatic output switching, according to selected operating mode.
Activation audible and visual indication.
HF frequency stabilization.
Stabilization of HF output according to the type of tissue.
Automatic interruption of HF output after 6 seconds of continuous operation.
Neutral electrode monitor circuit for monopolar modes (audible and visual indication of
anomaly).
Impossible activation when ground plate cable is not connected.
Output power will be stopped if the inside temperature exceeds max value (audible and
visual indication of anomaly).
HFS 100 only:
Activation timer programmable from 0.01 to 0.99 seconds. It can be excluded if necessary.
Digital selection of operation modes with LED indication, and digital HF power control with
display indication.
Other features:
External case made of painted steel.
The handpiece, cable and electrodes can be sterilized in autoclave at 121 °C wrapped.
Compactness and reliability: the most compact instruments on the market.
Max HF output power (measured on 1000 resistive load):
(output power tolerance: ±15%)
COAG
Operating Mode: CUT CUT/COAG COAG
BIPOLAR
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Standard supplies:
N° 1 mains cable.
N° 2 spare fuses 250 Vac / 3.15 A FAST / 5 x 20 mm.
N° 1 active electrode handpiece with cable and connector.
N° 1 cable with connector for disposable double ground plate.
N° 6 short electrodes (2 for cut, 2 for coagulus, 2 for biopsy).
N° 1 disposable double ground plate.
N° 1 pneumatic foot switch with joining tube (it can be screwed to the floor).
N° 1 user’s manual.
Optional supplies, spare parts and consumables:
Art. CONT0021: Electrode holder, autoclavable at 134°C.
Art. MDP00105: Active electrode handpiece with cable and connector for HFS 50, HFS 95, HFS 100,
autoclavable at 121°C wrapped.
Art. MDP00248: Cable with connector for disposable double plate for HFS 95, HFS 100.
Art. MDP00297: Cable with connector for conductive rubber double plate for HFS 95, HFS 100.
Art. ACCSTR09: Pneumatic foot switch with joining tube (it can be screwed to the floor).
Art. 330: Bipolar forceps with cable and connectors for HFS 95, HFS 100, autoclavable at 134°C.
Short active electrodes, Long active electrodes, Neutral electrodes
autoclavable at 134°C autoclavable at 134°C (ground plates):
(general purpose): (gynecology): Art. ACCELS04:
Art. 446: thin wire (cut). Art. 452: lance (cut). Disposable double ground
Art. 447: thick wire (cut). Art. 453: small ball (coagulus). plate.
Art. 448: small ball (coagulus). Art. 454: big ball (coagulus). Art. ACCELS06:
Art. 449: big ball (coagulus). Art. 455: round loop (biopsy). Conductive rubber reusable
Art. 450: round loop (biopsy). double ground plate,
Art. 451: oval loop (biopsy). autoclavable at 121°C.
WARNING
Use only original supplies and spare parts, available through our costumer service.
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APPENDIX A
Graphic 1 (HFS 95, HFS 100): output power according to the load
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Graphic 2 (HFS 95, HFS 100): power setting in mode monopolar cut
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Graphic 3 (HFS 95, HFS 100): Power setting on a 1000 ohm load
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Graphic 4 (HFS 95, HFS 100): power setting on a 200 ohm load
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ANNEX 1
EMC TABLES
Included below are EMC tables for emissions and immunity compiled according to the results obtained by tests
performed, as indicated in EN 60601-1-2 article 6. These informations have to be reported by the manufacturer in
the documentation accompanying the product.
Emission aspects
Emission test Conformity Electromagnetic environment - guide
RF emissions Group 1 When not activated, electrosurgery units HFS 95 and HFS 100 use RF energy only
Cispr 11 for their internal work.
Therefore their RF emissions are very low and reasonably not a source of
interference for nearby electronic appliances.
When activated, they emit RF energy that is necessary to their functioning.
Therefore there is a potential risk of interference on nearby electronic appliances.
RF emissions Class A Electrosurgery units HFS 95 and HFS 100 are suitable to be operated in any
Cispr 11 building, except: domestic or residential buildigs and buildings that are directly
wired to a low voltage mains network that feeds also domestic or residential
buildings.
It is possible to use the units in any kind of building, included domestic and
residential ones and those directly connected to low voltage public mains network
that feeds also domestic or residential buildings, by taking cares during their
installation. In other word, by giving the guarantee of an increased distance of
installation with respect to potentially sensitive appliances.
Harmonic emissions Class A It is possible to use the units in any kind of building, included domestic and
IEC 61000-3-2 Conform residential ones and those directly connected to low voltage public mains network
that feeds also domestic or residential buildings.
Voltage floatings / flickers Conform
emissions
IEC 61000-3-3
Immunity aspects
Electrosurgeries HFS 95 and HFS 100 are designed to work in the electromagnetic environment described below. The
costumer or the user should check that the units will be used in such environment.
Immunity test Test level Conformity level Electromagnetic environment - guide
EN 60601-1-2
Electrostatic discharges 6kV in contact 6kV in contact The floors must be made by wood, calcestruzzo or
(ESD) 8kV in air 8kV in air ceramics. If the floors are covered by sintetic material,
EN 61000-4-2 relative humidity should be at least 30%.
Electrical fast transients / 2kV power 2kV power Quality of mains supply should be that of a typical
bursts supply lines supply lines commercial or clinical environment.
EN 61000-4-4
Surges 1kV differential 1kV differential Quality of mains supply should be that of a typical
EN 61000-4-5 mode mode commercial or clinical environment.
Voltage holes, short < 5% UT < 5% UT Quality of mains supply should be that of a typical
interruptions and voltage (>95% UT hole) (>95% UT hole) commercial or clinical environment.
variations on input lines for 0.5 cycles for 0.5 cycles If the user wants the unit continue to work even during
EN 61000-4-11 40% UT 40% UT mains supply blackouts, it is reccomended to feed the
(60% UT hole) (60% UT hole) unit through an uninterruptible power supply (UPS)
for 5 cycles for 5 cycles group.
70% UT 70% UT
(30% UT hole) (30% UT hole)
for 25 cycles for 25 cycles
< 5% UT < 5% UT
(>95% UT hole) (>95% UT hole)
for 5 seconds for 5 seconds
Magnetic fields at line 3 A/m 3 A/m Magnetic fields at line frequency should have levels
frequency typical of a commercial or clinical environment.
EN 61000-4-8
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RF immunity aspects
Electrosurgeries HFS 95 and HFS 100 are designed to work in the electromagnetic environment described below. The
costumer or the user should check that the units will be used in such environment.
Immunity test Test level Conformity level Electromagnetic environment - guide
EN 60601-1-2
Conducted RF 3 Veff from 150kHz 3 Veff from 150kHz Portable and mobile RF communication sets should not
EN 61000-4-6 to 80MHz to 80MHz be used close to any part of the unit, included cables,
except when the reccomended separation distances,
Radiated RF 3 Veff from 80MHz 3 Veff from 80MHz evaluated using the applicable formula at the
EN 61000-4-3 to 2,5GHz to 2,5GHz transmitter frequency, are met.
Reccomended separation distances:
d = 1,2 P from 150kHz to 80MHz
d = 1,2 P from 80MHz to 800MHz
d = 2,3 P from 800MHz to 2,5GHz
where P is the maximum nominal output power of the
transmitter, expressed in watt (W) according to the
manufacturer of the transmitter, and d is the
reccomended separation distance, expressed in meters
(m).
Field intensity of fixed RF transmitters, as ascertained by an electromagnetic investigation of the site, might be under the level
of conformity for each frequency range.
Interference may arise in the neighbours of apparatuses marked with the following symbol:
Reccomended separation distance between portable and mobile communication sets and HFS 95 and HFS 100
electrosurgery units.
Electrosurgeries HFS 95 and HFS 100 are designed to work in an electromagnetic environment where RF radiated
interferences are under control. The costumer or the user may contribute in preventing electromagnetic interferences by
assuring a minimal distance between mobile and portable RF transmitter units and the electrosurgery, as reccomended below,
according to the maximum output power of the RF communication apparatuses.
Maximum nominal output Separation distance at transmitter frequency (m)
power of the transmitter From 150kHz to 80MHz From 80MHz to 800MHz From 800MHz to 2GHz
(W) d = 1,2
P d = 1,2
P d = 2,3
P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters with maximum nominal output power other than those reported above, the reccomended separation distance in
meters (m) may be evaluated by using the applicable formula at the transmitter frequency, where P is the maximum nominal
output power of the transmitter, expressed in watt (W) according to the manufacturer of the transmitter, and d is the
reccomended separation distance, expressed in meters (m).
Notes:
(1) At 80 MHz and 800 MHz the upper frequency range must be applied.
(2) The overstated guidelines could be not applcable in every possible situation. Electromagnetic propagation is influenced by
absorbtion and reflection due to structures, objects and people.
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LIARRE S.r.l.
Via G. di Vittorio, 5
40020 CASALFIUMANESE (BO)
Tel. +39 0542 667066 – Fax +39 0542 668000
e-mail: info@liarre.it – http://www.liarre.it
Cap. Soc. euro 10.800 i.v.
R.I. – C. F. 02387110378 – R.E.A. BO n. 278761
N. Mec.”M.” BO 001512 – Cod. Id. INTRA IT e P. IVA 00574751202
DICHIARAZIONE DI CONFORMITÀ
CONFORMITY DECLARATION
DECLARATION DE CONFORMITÉ
Nome del fabbricante: LIARRE S.r.l.
Manufacturer’s name:
Nom du fabricant:
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VIA G. DI VITTORIO 5
40020 CASALFIUMANESE (BO)
TEL +39 0542/667066
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