MUB.

001
USER’S MANUAL Rev. 01 – March 2005

LIARRE S.r.l.
Via G. di Vittorio 5 – 40020 CASALFIUMANESE (BO) - ITALY
Tel 0542/667066 – Fax 0542/668000

User's Manual

HIGH FREQUENCY ELECTROSURGERIES

HFS 45 – HFS 50

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 MUB.001
USER’S MANUAL Rev. 01 – March 2005

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

First Edition, March 2005

Printed in Italy

Information regarding this manual

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 45 – HFS 50 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.

Writing conventions used in this manual

Bold face type is used to highlight some sections of this document.

Note

The notes emphasize particular information in the text.

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.

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.

Goods under warranty are considered free LIARRE's warehouse (ex-works).

When goods are to be returned, after LIARRE's approval, please first carefully follow the below-mentioned
packing instructions and enclose a copy of the purchase receipt in the carton.

ATTENTION
The customer is responsible for damages caused by improper packing.
LIARRE advises to use the original packing materials and insure goods during shipment.

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.

DESTINATION FOR USE

HFS55 / HFS 50 are destined for use

in small precision surgery, in dental and veterinary field.

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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 45 and HFS 50.
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 45. PAGE 17
3.2 Front panel HFS 50. PAGE 18
3.3 Back panel HFS 45 and HFS 50. PAGE 19
3.4 Sound signals of HFS 45 and HFS 50. PAGE 20
3.5 Graphic symbols on the panels of HFS 45 and HFS 50. PAGE 20
CHAPTER 4 : USE OF THE UNIT PAGE 21
4.1 Installing and using the electrosurgery HFS 45 and HFS 50. PAGE 21
4.2 Particular precautions for use. PAGE 25
4.3 Maintenance after use. PAGE 25
4.4 Waste disposal after the use. PAGE 25
CHAPTER 5 : TECHNICAL FEATURES OF ELECTROSURGERIES HFS 45 AND HFS 50 PAGE 26
5.1 Electrosurgeries HFS 45 and HFS 50. PAG. 26
APPENDIX A PAGE 28
Graphic 1 HFS 45, HFS 50 output power according to the load in cut mode. PAGE 28
Graphic 2 HFS 45, HFS 50 output power setting according to the load in cut/coag 1 mode. PAGE 28
Graphic 3 HFS 50 output power setting according to the load in cut/coag 2 mode. PAGE 29
Graphic 4 HFS 45, HFS 50 output power setting according to the load in coagulation mode. PAGE 29
Graphic 5 HFS 45, HFS 50 output power settino in cut mode (load: 50 - 2500 ohm). PAG. 30
Graphic 6 HFS 45, HFS 50 output power settino in cut/coag 1 mode(load: 50 - 2500 ohm). PAG. 30
Graphic 7 HFS 50 output power settino in cut/coag 2 mode (load: 50 - 2500 ohm). PAG. 31
Graphic 8 HFS 45, HFS 50 output power seting in coag mode (load: 50 - 2500 ohm). PAG. 31
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.

1.2 – General information on HF (high-frequency) SURGERY

or RADIOSURGERY appliances
Radio knives are electromedical instruments supplying high-frequency (over 0.3 MHz) currents to
obtain body tissue modifications such as cut (electrotomy) or coagulation. HF currents can be applied to
the patient in the following ways:
MONOPOLAR TECHNIQUE:
by using a small-surface active electrode and a large-surface neutral electrode;
BIPOLAR TECHNIQUE:
by using a single bipolar electrode, such as a forceps whose halves are insulated one from the other.
The output power can considerably vary from one instrument to another, according to the
application fields: from a minimum of 10 W for special-purpose radio knives (ophthalmology and
dermatology) up to 400 W for general-purpose in-patient surgery (operating theatres). The general-
purpose radio knife peak output voltage can reach 10 KV.
Minor surgery instruments to be used for dental, ophthalmological, ENT, aesthetics, dermatological
applications usually have output power levels not exceeding 50 W. In minor and medium surgery usually
requires power values not exceeding 100 W.

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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 – Nature of the dangers of HF surgery

The high currents and electric voltages supplied by the radio knife may represent hazard for the
patient and/or the operator, and may generate electromagnetic interferences to other devices in contact
with or implanted in the patient. Any sparks or electric arcs generated between the electrode and the body
tissues, or, for example, a metal forceps, may cause frequency currents (lower than 0.2 MHz), resulting in
unwanted neuromuscular stimulation.
A few examples are given herebelow of the most common hazards connected with use of a radio
knife.

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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 BURNS CAUSED BY THE NEUTRAL ELECTRODE

If the neutral electrode is not in perfect contact with the patient, unwanted local heating may occur
in the surrounding tissue, possibly resulting in burns.
Improper neutral electrode contact may be caused by:
- neutral electrode surface too small for the specific application;
- neutral electrode not perfectly making contact with the patient;
- neutral electrode accidentally insulated from the patient because of interposed insulating film,
sterile cloths or other non-conductive material;
- discontinuous electrode contact.
 BURNS CAUSED BY ELECTRODES OR CABLES
They may be caused by:
- accidental activation of an active electrode left close to the patient. Sterile cloths do not usually
provide sufficient HF current insulation, especially if they are wet or damp;
- surgical clips used to fix the cloths around the patient and to the operating table should not be
used to support the cables: the terminals of these clips might penetrate the cables and damage
their insulation;
- the operator might burn his/her fingers while coagulating tissues or vessels with a non-insulated
forceps in contact with the active electrode. In this case, the radio knife high output voltage
might cause an electric arc piercing the surgical gloves.
WARNING
Higher pressure points (caused by bone protuberances or gaps in the neutral electrode surface) may result
into HF current higher densities and subsequent excessive temperature increase in those points. Burn risks
may also result from skin folds near the edges of the neutral electrode, as well as from folding of small
skin areas due to the relative sliding of the table below the patient who is not then properly lifted.

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.

1.3.2 – Electrocution Hazard

Low-frequency electric voltage (usually lower than 0.2 MHz) caused by electric arcs or sparks may
cause unwanted neuromuscular stimulations. While coagulating tissues or blood vessels by using
uninsulated forceps, the operator may feel a current flow if an electric arc is produced between the active
electrode and the forceps, should his/her gloves become conductive because they are wet.

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1.3.3 – Fires and explosions

The electric sparks generated in the active electrode during normal use may cause fires, if they
occur in the presence of flammable products or if the radio knife is used in atmospheres with heavy
concentrations of oxygen, endogenous gases or nitrogen protoxide (flammable anaesthetic gases). When
anaesthetic gases are used, these should either be diverted or the operator should work outside their range
of action.
Make sure flammable products used for cleaning or hand disinfection purposes are thoroughly
evaporated before the radio knife is turned on.
WARNING
THE ELECTROSURGERIES HFS 95 AND HFS 100 MUST NOT BE USED NEARBY ANAESTHETICS OR
FLAMMABLE GASES.

1.3.4 – Electromagnetic Interferences

When the radio knife is working, electromagnetic interferences may occur with neighbouring
electromagnetic equiment, e.g. E.C.G. monitors, B.P. monitors and other monitoring devices, infusion
pumps, cardiac pacemakers. In fact, as you will see, one of the few serious obstacles not recommending
the use of HF surgery techniques is represented by cardiac stimulators implant receivers. Special care is
required in these cases because radiofrequency interferences coming from the knife might disturb or
prevent the stimulator normal operation, causing arhythmias in heart ventricles.
WARNING
THE ELECTROSURGERIES HFS 45 AND HFS 50 MUST NOT BE USED ON PATIENTS
WHO HAVE A HEART PACE-MAKER AND/OR OTHER LIFE SUPPORT DEVICES

BECAUSE THEIR WORK MIGHT BE COMPROMISED BY THE ELECTROMAGNETIC INTERFERENCE

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 45 and HFS 50
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 45 and HFS 50 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

Simple harmonic current at HF Surgery output

This is the first critical parameter affecting the appliance performance overall quality relatively high
working frequency value is particularly indicated for highly sensitive tissues (for dental, ENT,
gynaecological, ophthalmological, aesthetic surgery, dermatological applications etc.) and will guarantee
suitable cutting depth without damaging the surrounding cellular layers, which would imply serious
complications during healing.On the other hand, too high frequency values would help HF dispersion: the
operation would not be easily controlled and patient risks would increase.
The three main electrosurgery working parameters, all operator-programmable, are described
herebelow:
 Operation mode: choice of HF current modulation percentage applied to the patient.
 Output power adjustment.
 Activation time setting radio knife.

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Dissection effect due to the electric curent flowing at tissue level

1: Handpiece 2: Active electrode
3: Neutral electrode plate 4: Organic tissue

2.2 – Operation modes

As compared to the whole of the other currently marketed appliances, HFS 95 and HFS 100 offer a
choice from as many as 4 operation modes corresponding to as many different patient-applied HF simple
harmonic current amplitude modulation factors. This allows the whole range of monopolar and
bipolar HF surgical applications to be effectively covered, the operation modes being:
- CUT: pure cut
- CUT / COAG 1: or CUT/COAG: cut with coagulation effect
- CUT / COAG 2: or CUT/COAG: cut with more coagulation effect (only HFS 50)
- COAG: micro coagulation
By means of a bipolar forceps, supplied on demand with cable and connectors, you can do a
bipolar coagulation.
The different possibilities and general application fields are listed herebelow, using as a reference
the HF output current which would be displayed by an oscilloscope.
It should be noted that the output power decreases proportionally to the applied modulation rate,
given the same position of the power control. Therefore, if the unit is set for a given output power in CUT
mode and then switched to another operating mode, the output power decreases accordingly, being at the
minimum in COAG mode.
CUT (pure cut - electrotomy):
It corresponds to HF simple harmonic current unmodulated amplitude. In HFS 50 it is indicated by
a yellow led.

Unmodulated amplitude HF curent

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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 45 and HFS 50 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 45 and HFS 50 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 / COAG1 (HFS 50), CUT / COAG (HFS 45) (cut with coagulation effect):
it corresponds to a sinusoidal HF current modulated in amplitude at 35% (at a low modulation
index). In HFS 50 it is indicated by a yellow LED.

35% HF amplitude-modulated HF current

This operation mode (and the relevant envelope of the patient-applied HF current particularly
indicated if you wish to make a cut while controlling bleeding. This is just on the biggest advantages of
electrosurgery compared to traditional surgery: the operator can work under controlled bleeding
conditions or absent bleeding conditions and in an aseptic environment (the environment is undoubtedly
sterile because of the considerable heat developing in the tissue). The difference between this operation
mode and the pure cut (CUT) mode lies in the fact that the HF current slight modulation helps the
coagulation characteristics to prevail over the pure cut characteristics by increasing the lateral heat on the
wound. The whole operation procedure described hereabove is also applicable to this mode.
Any type of electrode can be used, according to the type of operation. It should be borne (in mind
that a large-surface ball electrode is particularly indicated for massive coagulation in relatively large
tissue areas.
CUT / COAG2 (only HFS 50), (cut with more coagulation effect):
It corresponds to a 50% amplitude HF modulated sinusoidal current (medium ondulation index). In
HFS 50 it is indicated by a yellow LED.

50% amplitude modulated HF current

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COAG micro monopolar coagulation:

COAG BIPOLAR (only with bipolar forceps, supplied on demand), bipolar coagulation:
it corresponds to a 60% amplitude modulated HF current (high modulation index). In HFS 50 it is
indicated by a light blue LED.

60% amplitude HF modulated current

The last operation modes are described together, because they have very similar characteristics and
have been developed for very special applications, from micro-coagulation (highly accurate and delicate
capillary coagulation), to massive operations on larger tissue areas, with both the monopolar technique
(special handpiece + neutral electrode) and the bipolar technique (using insulated forceps).
The HF current envelopes supplied by the instrument in these operation modes are optimized for
any type of coagulation operation, because the high amplitude modulation index results in easily
adjustable lateral heat. However, for monopolar technique applications, the types of electrode used are
ball electrodes (for coagulation of large tissue areas like in tumor surgery applications) or pointed conical
electrodes (for micro-coagulation and to stop haemorrhagies at capillary level). Large face electrodes will
distribute HF current energy effectively over the tissue surface: this proves to be sufficient in most of the
cases to stop bleeding.
In the bipolar technique, the bleeding vessels are tied using the special insulated forceps complete
with a connecting cable or, in monopolar mode, you can clamp the vessel with a forceps (or a haemostat)
on which the active electrode should be placed to obtain an electric contact: coagulation will be obtained
in the point of contact with the blood vessel.
In general surgery, the range of applications of coagulation is very wide. The choice an electrode
type is also made according to the field of use. For special uses, thin needle cutting electrodes can also be
used, to obtain a very limited extension of the tissue coagulation field (e.g. cyclodiathermy for retinal
removal, depilation etc.).
Factors influencing coagulation:
1) HF current waveform;
2) HF output power (usually with settings close to maximum setting values);
3) activation time.
Coagulation of a larger tissue area can be controlled by both choosing an electrode (e.g. a ball
electrode) and by adjusting the HF power supplied by the instrument. Usually a limited power level,
coagulation is slower and covers a large tissue area.
By increasing HF output power, the coagulation effect is quicker and limited in space: the cellular
lay is dehydrated near the electrode and the applied HF current flow is gradually decreased due to the
progressive increase in the electric resistance offered by the tissue.

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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 SWITCHED 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 45 and HFS 50 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 50, knob-controlled in model
HFS 45);
2) patient-applied HF current envelope selection in 4 different operation modes, (digital and LED-
indicated in model HFS 50) and 3 operation modes in HFS 45;
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 50 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.

2.3 – Basic information and problems connected to HF surgery

Many doctors do not feel confident with electrosurgical techniques, and have many doubts on the
working principle of the instrument and on the interactions between HF current and biological tissues.
LIARRE wishes to provide explanations in handbook, based on its manufacturer's experience and
long-standing fruitful research cooperation with experienced electrosurgery specialists. A few specific
issues of dentistry will be dealt with. They are also easily adaptable to any other medical field. At the end
of this chapter you will find a an essential list of references for further information.
The average level of HF surgery danger, if the general rules mentioned so far are complied with, is
similar to the level of danger resulting from the use of micromotors, turbines, root canal instruments,
which are all more commonly used in dentistry.
The use of instruments like HFS 45 and HFS 50 will dramatically reduce the risk of patient damage;
however is up to the operator to learn the HF surgery technique and to become familiar with the radio
knife by practising on steaks and veal mandibles.
It should be observed that the experimental results which can be obtained on steaks (although
working conditions are different from those of the oral cavity) are meaningful because they show a few
basic characteristics of instrument and because they allow the doctor to become familiar with the
instrument, to appreciate its technical features and to acquire a precious knowledge of the interactions
between HF current and biological tissues.
To practise the monopolar technique, place neutral electrode plate on an insulating work surface
and place the meat on the plate before start working.
A direct comparison between the HF surgical technique and traditional knife shows the following
advantages offered by the former, which largely justify its use:
 NO PRESSURE MUST BE APPLIED ON THE TISSUE;
 ACCESSIBILITY TO THE ORAL CAVITY (ESPECIALLY IN REAR AREAS) IS CONSIDERABLY
IMPROVED. THANKS TO EXTREMELY HANDY HANDP1ECES;
 THE GINGIVA CAN BE EASILY MODELLED AND LEVELLED (PLASTIC OPERATIONS);
 THE ELECTRODE TIP HAS A LOW BACTERIAL LOAD AND WILL REMAIN STERILE DURING THE
OPERATION: THE WORKING AREA BACTERIAL LOAD IS THEREFORE DECREASED BY THE
ELECTRODE ITSELF;
 CONTROLLED OR ABSENT BLEEDING WORKING CONDITIONS.

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 50 instrument with preset timed mode
(maximum time 0.5 seconds): this activation time is more than sufficient for this kind of operation. If
treatment of the same tissue area must be repeated, wait for 10 seconds before applying the electrode
again.

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RECOMMENDATIONS FOR THE USE OF THE ACTIVE ELECTRODE HANDPIECE:

1) Always use a support;
2) make short, regular movements;
3) always place the active electrode at right angles to the tissue surface;
4) do not apply pressure;
5) never stop in the same area.

2.4 – Clinical indications in DENTISTRY

 Clinical crown elongation (for aesthetic reasons or neck decay);
 subgingival suicus, for aesthetic and functional reasons in case of high quality denture fitting;
 dentin desensitization;
 root canal sterilization: the sterilization obtained by electrosurgery is effective and long lasting, as
is shown by a number of clinical research works. It is particularly indicated f gangrenous teeth;
 haemorrhage control by coagulation;
 frenotomy can be carried out quickly and with no haemorrhage;
 exposure of roots to be used as bridgework pillars;
 destruction of fistulous orifices;
 root canal instrument breaking;
 elimination of mucosal hypertrophia, in cavities, edentulous saddles, at gingival edges near fixed
and mobile dentures;
 gingivoplasty: the gingival remodelling performed with instruments HFS 95 and HFS 100 is
unrivalled. It offers the following advantages if compared to traditional knife remodelling: no
haemorrhage, perfect surgical field visibility, smaller-scale interventions, no postoperative pain, no
need of surgical pack, quick re-epithelization with very good aesthetic results;
 eighth tooth dysodontiasis: immediate pain relief is almost always obtained;
 paedodontics and orthodontics operations: retained teeth, band hypertrophia, gingival edge
reshaping;
 biopsies: the risk of cancerous cell scattering is avoided.Tissue removal can be performed at the
same time to submit small oral cavity lesions to bioptic examination;
 interventions on gingival pockets;
 apicectomies;
 creation of subgingival sulci for aesthetic and functional denture requirements.

ESSENTIAL LIST OF REFERENCES

Calciati R. ATLANTE Dl ELETTROCHIRURGIA DENTALE Mortara, C.I.E.G., 1975, V Edizione
Waxman, H.N. THE ELECTRONIC SCALPEL Worcester Med. News, 31: 28-29, May 1967
Oringer, M. J. ELECTROSURGERY IN DENTISTRY Philadelphia, W. B. Sanders Co., 1967
Schon F. L'ELETTROCHIRURGIA IN ODONTOIATRIA – Quintessenz - Verlag, Berlino
LE BASI DELLA TECNICA ELETTROCHIRURGICA
Malone W. F., ELECTROSURGERY IN RESTORATIVE DENTISTRY J. Pros. Dent., 20: 417-425, 1968
Manning J. L.
Calciati R., ELECTROSURGERY IN DENTISTRY Springfield, Charles C. Thomas, 1974
Malone W. F.
Calciati R. COMUNI CAUSE DI ERRORE NELLA Ergonomia Dent., 3: 153-158, 1970.
SPERIMENTAZIONE ELETTROCHIRURGICA.
PROPOSTE DI UNA METODOLOGIA DI RICERCA

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CHAPTER 3
Description of the control knobs and buttons, signals and connections of
HFS 45 and HFS 50
3.1 – Back panel of HFS 45 and HFS 50
Back panel HFS 45
(a) (β) (α) (ε) (A) (c)

Back panel HFS 50

(b) (d) (e) (d)

CONTROL KNOBS:
(A): On/off switch (O = the machine is switched off ; I = the machine is switched on).
CONNECTIONS:
(α): Connection to the mains cable.
(β): Connection to the foot pedal (enter the connector of the cable and screw).
(ε): Fuse holder (to take it out press the hook on the left, towards the mains cable connector.
In order to do this operation you must disconnect the mains cable).
INDICATIONS:
(a): Details of the machine:
 voltage (230 Vac – 50/60 Hz),
 max absorbed power (100 VA),
 output signal frequency (1 MHz),
 max output power (50 W on a nominal resistive load of 500 ohm),
 work cycle (20% max. – 6 activation seconds followed by 30 rest seconds),
 REF.: name of the machine (HFS 45 or HFS 50),
 SN.: serial number.
(b): Identification of the manufacturer.
(c): CE mark with identification of the Notified Body (see graphic symbols table).
(d): Indications and / or safety warning graphic symbols (see graphic symbols table).
(e): Featyres of the fuses.

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3.2 – Pannello anteriore dell’elettrobisturi HFS 50

Pannello anteriore elettrobisturi HFS 50
(h) (5) (3) (g) (4) (f) (2)

(H) (G) (D) (E) (F) (γ) (f) (δ)

CONTROL BUTTONS:
(D): Operation mode selection button (cut, cut mixed to coagulation 1, cut mixed to coagulation 2,
coagulation,
bipolar coagulation):
 You can select the operation mode by pressing repeatedly the button, clockwise, from top to bottom;
 output (monopolar – connectors (γ), (δ) – or bipolar – connectors () – is automatically changed according to the
selected mode;
 the control operates also during the activation of the unit;
 when the unit is switched on the operation mode is the latest selected one.
(E): decrease power button,
(F): increase power button:
 you can increase or decrease of one step at a time the indication on the display (4) and consequently the output
power by pressing the button;
 by keeping the button pressed you will reduce or increase the indication on the display (4) and consequently the
output power until the button is released or until you reach the minimum or the maximum value;
 the control operates also during the activation of the unit.
 When the unit si switched on it will automatically display the minimum power value.
(G): activation timer button:
 By pressing the button you switch on the timer. By pressing it again the timer is disactivated.
 When the unit is switched on the timer is not activated.
(H): Selectors of the activation time:
 The time is set by pressing the buttons + and – on top and below the figures of the selectors; the figures indicate
the set time in hundreds of second (from 01 to 99 hundreds of second);
 When the unit is switched on the timer is not activated.
CONNECTIONS:
(γ): Connection to the active electrode (handpiece): coaxial connector.
(δ): Connection to the neutral electrode (ground plate): three poles connector.
LED SIGNALS:
(2): Orange led: the unit is activated (output power on).
(3): Led indicating the selected operation mode (blu for coagulation, yellow for cut and mixed modes):
 CUT (pure cut): non modulate output (output power: 100% of the nominal power – 50 W on 500 ohm),
 CUT/COAG 1 (cut mixed to coagulation): modulation at 35% (output power: 65% of the nominal power – 32.5
W on 500 ohm),
 CUT/COAG 2 (cut mixed to coagulation): modulation at 50% (output power: 50% of the nominal power – 25 W
on 500 ohm),
 COAG (monopolar coagulation): modulation at 60% (output power: 40% of the nominal power – 20 W on 500
ohm),
(4): Display indicating the output power:
 Relative indication from 01 (minimum level) to 50 (maximum level).

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(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 – Front panel HFS 45
Front panel HFS 45
(1) (g) (f) (2)

(B) (C) (δ) (f) (γ)

CONTROL KNOBS:
(B): operation mode selector (cut, cut/coag, coag).
 The control is operation also during the activation of the unit.
(C): Output power regulation potenziometer (1 = minimum; 10 = maximum).
 The control is operation also during the activation of the unit.
CONNECTIONS:
(γ): Connection to the active electrode (handpiece): three poles connector.
(δ): Connection to the neutral electrode (round plate): connector  4 mm.
LIGHT SIGNALS:
(1): Green led: the unit is switched on.
(2): Orange led: the unit is activated (output power).
INDICATIONs:
(f): Indication and / or safety warning (see v graphic symbols table).
(g): Indication of the selected operation mode by means of the selector (B):
 CUT (pure cut): non modulated output (output power: 100% of the nominal power – 50 W on 500 ohm),
 CUT/COAG (cut mixed to coagulation): modulation at 35% (output power: 65% of the nominal power – 32,5 W
on 500 ohm),
 COAG (coagulation): modulation at 60% (output power: 40% of the nominal power – 20 W on 500 ohm).

3.4 – Sound signals of HFS 45 and HFS 50

Switch on: two short tones when it is switched on.
Activation: continuous sound signal which lasts for the whole activation time (output power on). The
notea changes according to the selected operation mode (cut, mixed modes cut/coag., coag.).
Alarm pedal pressed when switching on the machine: slow intermittent sound signal. If the pedal was
pressed when the unit was switched on you have to release the pedal and wait for the sound to stop.
Alarm in case of fault: from one to five short tones followed by a long pause with repetition of teh
sequency. They all indicate a different fault condition:
- 1 tone: output power potentiometer (C) disconnected from the ground side (red wire) (EB 45);
- 2 tones: output power potentiometer (C) disconnected from the alimentation side : (brown wire) or from the cursor
(white wire) (EB 45);

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3.5 – Graphic symbols on the panels of HFS 45 and HFS 50

SYIMBOL POSITION MEANING

Back panel CE mark and identification of the Notified Body

On/off switch (back panel)

No voltage (OFF, switched off)

On/off switch (back panel)

Voltage (ON, switched on)

Connector of the pedal (back

Pedal commutator
panel)

Back panel Protection degree of the unit IP (IP 20)

Back panel and front panel,

Attentino
next to the output connectors

Back panel Type BF machine, defibrillation proof

Front panel, next to the output

Applied part type BF
connectors

Front panel, next to the output

Neutral electrode isolated from round at high frequency
connectors

Front panel, next to the output

Non ionising radiations
connectors

Front panel, next to the output

Dangerous voltage
connectors

Front panel HFS 50, next to

the power controls and Variability
indications

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CHAPTER 4
Use of the system
4.1 – Installation and use of the electrosurgery HFS 45 and HFS 50
The installation of the high-frequency surgery instruments HFS 45 and HFS 50 is simple and
straightforward, because it only requires compliance with a few simple rules. The radio knife should be
installed in a convenient position for the operator, after making sure it is a dry place away from heat
sources and well ventilated. Due to internal heat dissipation reasons, it is important not to place any
objects (e.g. cloths, blankets etc.) between the machine and its support surface or near the ventilation
openings. I riferimenti tra parentesi sono relativi alle immagini dei pannelli frontali e posteriori delle
apparecchiature, in questo stesso capitolo.
The connection to the mains system must be made exclusively with the supplied cable, making sure
that the installation has a round connection (necessari for safety reasons) and that the features of the
mains system correspond to what indicated in the details of the machine (a) (230 Vac / 50-60 Hz). Do not
use extensions.
Connect the mains cable by entering the trapezoidal connector on the back panel (α) and on a mains
plug.
Connect the pedal to the four poles connector (β), indicated by the symbol on the back panel;
the reference tail on the body of the panel connector must correspond to the one on the plastic of the
cable’s connector; screw the connector. Put the pedal in a convenient position.
Connect the active electrode cable (handpiece and relevant electrode) to the connector (γ) on the
front panel (3 poles connector for HFS 45 or coaxial connector for HFS 50).
Connect the cable of the neutral electrode (which ends with a plug to be entered on the cylindric
plate or in the conductive rubber rectangular plate) to the connector (δ) (4 mm for HFS 45 or 3 poles
connector for HFS 50) on the frontal panel.
the reference tail on the body of the panel connector must correspond to the one on the plastic of the
cable’s connector; screw the connector
Note
If the 3 poles connextor is not connected to the cable of the relevant electrode (active for HFS 45 or
neutral for HFS 50) the unit will not activate.
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

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Choose a suitable electrode (wire, yellow for cut, ball, blu for coag., loop, white for biopsy) and
enter it into the handpiece, screwing it tightly. The mandrel opens by turning it anticlock wise (looking at
the handpiece on the side of the electrode) and closed by turning it clockwise.
WARNING
Use only sterile electrodes
Choose the neutral electrode which you intend to use and connect it to the end of the cable of teh
neutral electrode. In order to make the plastic protection slide and to enter the pin, the pin must be entered
while pressing the block mechanism (curved part on the plastic body).
Make sure that all the connectors are firmly connected and their ring nuts tightened hard. In dental
applications, the neutral electrode cylindrical plate must be firmly grasped by the patient during the
operation.
When you use a rectangular plate make sure it is in perfect contact with the patient, on its whole
surface, in a wide tissue area, next and opposite to the operation area.
The stand by position, when switched on from the on/off switch on the back (A) is indicated by a
green led (1) (ON) in HFS 45 and by the switching on of the display (4) of output power indication (HF
POWER) and of one of the four leds (3) for the selection modes in HFS 50.
The la test, when switched on, will automatically set on the la test selected operation mode. The
power will be at the minimum level (the display will show 01) and the timer will not be activated.
Both models, when switched on, make a sound signal (two short tones). Viceversa, a slow
intermittent sound indicates that the machine has detected that the pesal was pressed when it was
switched on. You must release the pedal to stop the alarm signal.
WARNING
If when switched on, or in any other moment during the activation, the unit detects a fault
condition you will hear a alarm signal of a sequenze of short tones (from one to five, according to
the fault) repeated after a pause.
In these conditions the unit will not work. You have to apply to our after sales service.
The selection of the mode is made by means of the commutator (B) wityh three positions (CUT,
CUT/COAG, COAG) in HFS 45, and by means of the button MODE (D) in HFS 50.
The output power regulation HF is made in HFS 45, by means of the potentiometer HF POWER
(C) with relative scale which varies from 1 to 10. In HFS 50 there are the to buttons HF POWER (E) and
(F), rapresented by a black arrow turned upwards and downwards, respectively to decrease and increase
the power, variable from 01 to 50.
NOTE
Display reading of the power level in model HFS 50 is of the relative type only, providing an
realistic idea of the HF output power (expressed in watts) in the CUT operating mode and with a
resistive load equal to the nominal load of 500 ohm.
In model HFS 45, 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.
Make reference to the graphics in Appendix A for a precise indication of the features of the output
power, according to the instrument and of the applied load.

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In all the models, when you press the pedal (activation HF), a orange led switches on (2)
ACTIVATED and you hear a continuos sound (different tone for each operation mode) which indicate the
output power. The signals will continue for the whole activation time.
For safety reasons, in order to limitate the risks of pressing the pedal by accident, the duration of the
output power is automatically limitated to a maximum of seconds, after which the unit will disactivate. To
restart the power you have to release the pedal and press it again. This safety feature, o both models, must
not be confused with the TIMER which is only in HFS 50.
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 50, 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.
To disactivate the timer you just have to press the button (G) TIMER ON again (the green led
switches off).

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Note
For safety reasons, the duration of the output power, set with the TIMER, depends on the pressare
mad eon the pedal: if the pedal is released the output power stops, even before the end of set time.
This effect is relevant if the selected time is equal or superior to 20  25 hundreds of second, since for
quicker times it is very difficult to be able to release the pedal before the set time expires.
For the long times it is necessary, if you do not want to stop the power earlier, to keep the pedal pressed
until the end of teh time.
The machines are internally protected against overload by means of a control of the output power
which, if above the limits is automatically reduced.
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.
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.

4.2 – 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.

4.3 – 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;

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- 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 – Disposing of the unit

The item does not contain neither toxic material nor batteries, therefore it can be eliminated among
the normal wastes, provided that there is no specific regulation about the obsolete electronic appliances.

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CHAPTER 5
Technical features of HF electrosurgeries HFS 45 and HFS 50
5.1 - Electrosurgeries HFS 45 and HFS 50
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 I units (with functional earth connection).
Protection rating against liquids
and dust penetration: IP20 (according to EN 60529).
Mains supply: 230 Vac 50/60 Hz.
Mains absorbed power: 100 VA.
Mains fuses: 2 x 1 A fast V~ 5x20 5x20 mm (line and neutral), reachable from the
outside on the back panel.
Output HF frequency: 1 MHz quartz controlled (± 100 ppm).
Case dimensions: 200 x 170 x 70 h mm
Weight: approx. 2.5 Kg
Control features:
 microprocessor controlled.
 FLOATING output circuit (type BF).
 Monopolar surgical techniques with separate outputs.
 Sound and visual activation sgnals.
 Sound alarm signal and stop of the output power if the pedal is pressed when the machine is
switched on
 Autodiagnosis, sound signal and stop of the output power in case of fault.
 Stabilization of HF frequency
 Stabilization of HF output according to the type of tissue.
 Automatic interruption of HF output after 6 seconds of continuous operation.
 Control and automatic HF limitations
HFS 45 only:
 Three operating modes: CUT (monopolar pure cut), CUT/COAG (monopolar cut with coagulus
effect), COAG (monopolar coagulus).
 No activation if the cable of the handpiece is not connected.
HFS 50 only:
 Four operating modes: CUT (monopolar pure cut), CUT/COAG1 (monopolar cut with light
coagulus effect), CUT/COAG2 (monopolar cut with stronger coagulus effect), COAG (monopolar
coagulus).
 No activation if the cable of the handpiece is not connected.
 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 ignifuge ABS.
 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 500  resistive load):

(output power tolerance: ±10%)
CUT/COAG 1 (HFS 50) CUT/COAG 2
Operation mode: CUT COAG
CUT/COAG (HFS 45) (HFS 50)

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Max output power HF: 50 W 32,5 W 25 W 20 W

Modulation: absent 35% 50% 60%

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Standard supplies:
 N° 1 mains cable.
 N° 2 spare fuses 250 Vac / 1 A FAST / 5 x 20 mm.
 N° 1 active electrode handpiece with cable and connector.
 N° 1 cable with connector for ground plate.
 N° 6 short electrodes (2 for cut, 2 for coagulus, 2 for biopsy).
 N° 1 cylindric ground plate.
 N° 1 foot switch with cable and connector.
 N° 1 user’s manual.
Optional supplies, spare parts and consumables:
 Art. CONT0021: Electrode holder, autoclavable at 134°C.
 Art. MDP00101: Active electrode handpiece with cable and connector for HFS 45 autoclavable at
121°C wrapped.
 Art. MDP00105: Active electrode handpiece with cable and connector for HFS 50, HFS 95, HFS 100,
autoclavable at 121°C wrapped.
 Art. MDP00102: Cable with connector for neutral electrode and cilindric ground plate for HFS 45.
 Art. MDP00026: Cable with connector for neutral electrode and cilindric ground plate for HFS 50.
 Art. MDP00305: Cable with connector for neutral electrode and rubber square ground plate for HFS
45.
 Art. MDP00306: Cable with connector for neutral electrode and rubber square ground plate for HFS
50.
 Art. MDP140: foot pedal.
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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Appendice A

Graphic 1 (HFS 45, HFS 50): output power according to the load in cut mode

Graphic 2 (HFS 45, HFS 50): output power according to load in cut/coag1 mode

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Grafico 3 (HFS 50): output power according to the load in mode cut/coag 2

Graphic 4 (HFS 45, HFS 50): output power according to the load in coag mode

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Graphic 5 (HFS 45, HFS 50): Reguolation of the output power in cut mode (load: from 50 to 2500 ohm)

Graphic 6 (HFS 45, HFS 50): Regulation of the output power in mode cut/coag 1 (load: from 50 to 2500 ohm)
NOTE: the curves on which there is a current limitation are interrupted in order to make the graphics easier to
read, they continue orizontally rightwards (the power remains constant to the increase of the regulation).

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Graphic 7 (HFS 50): power regulation in mode cut/coag 2 (load: from 50 to 2500 ohm)

Graphic 8 (HFS 45, HFS 50): power regulation in mode coag (load: from 50 to 2500 ohm)
NOTE: the curves on which there is a current limitation are interrupted in order to make the graphics easier to
read, they continue orizontally rightwards (the power remains constant to the increase of the regulation).

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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
Cispr 11 only 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
EN 61000-4-6 to 80MHz to 80MHz not be used close to any part of the unit, included
cables, except when the reccomended separation
Radiated RF 3 Veff from 80MHz 3 Veff from 80MHz distances, evaluated using the applicable formula at
EN 61000-4-3 to 2,5GHz to 2,5GHz the 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: liarre@interbusiness.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:
Indirizzo del fabbricante: Via G. di Vittorio, n°5
Manufacturer’s address: 40020 Casalfiumanese (BO) – ITALIA
Adresse du fabricant:
Nome del prodotto: ELETTROBISTURI AD ALTA FREQUENZA
Product name: HIGH FREQUENCY ELECTROSURGERIES
Nom du produit: ELECTROBISTOURI A HAUTE FREQUENCE
Nome del modello: HFS 95
Model name: HFS 100
Nom du modèle:
DICHIARA – DECLARES – DECLARE
Che i prodotti suddetti sono stati progettati e costruiti in conformità alle prescrizioni della Direttiva 93/42/CEE recepita in Italia
con D.L. n°46 del 24/02/97, come certificato dall’Organismo Notificato CERMET n° 0476 nel certificato MED-9807.
That the above mentioned products are projected and manufactured in conformity to the Directive 93/42/CEE registered in Italy
by D.L. no. 46 dated 24/02/1997, as certified by Notified Body CERMET no. 0476 in the certificate MED-9807.
Que les produits ci-dessus ont été conçus et fabriqués en conformité aux prescriptions de la Directive 93/42/CEE enregistrée en
Italie par le D.L. n° 46 du 24/02/97, comme certifié par l’Organisme Notifié CERMET n° 0476 sur le certificat MED-9807.
I prodotti rispondono alle seguenti norme o direttive:
The products are in conformity to the following standards:
Les produits sont conformes aux normes ou directives suivantes:
- EN 60601-1, Apparecchi elettromedicali – Parte 1: Norme generali per la sicurezza.
Electromedical appliances – Part 1: General Safety Norms.
Appareils électromedicaux – Partie 1: Normes generales pour la sécurité.
- EN 60601-1-2, Apparecchi elettromedicali – Parte 1: Norme generali per la sicurezza – 2 – Norma
collaterale: Compatibilità elettromagnetica – Prescrizioni e prove.
Electromedical appliances – Part 1: General Safety Norms – 2 Collateral Norm:
Electromagnetic Compatibility – Prescriptions and tests.
Appareils électromedicaux – Partie 1: Normes generales pour la sécurité – 2 Norme
collaterale : Compatibilité électromagnetique – Prescriptions et tests.
- EN 60601-2-2, Apparecchi elettromedicali – Parte 2: Norme particolari per la sicurezza degli
apparecchi per elettrochirurgia ad alta frequenza.
Electromedical appliances – Part 2: Particular Norms for the safety of high
frequency electrosurgeries.
Appareils électromedicaux – Partie 2: Normes particulières pour la sécurité des
appareils pour électrochirurgie à haute fréquence.
- Directive 93/42/CEE, per i dispositivi medici, for medical devices, pour les dispositifs medicaux.

Il legale rappresentante – Legal representative – Le répresentant legal

Giuseppe Montanari Reggiani

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