Satelec Servotome User manual

2

English 4
Français 18
Español 32
Deutsch 46
Nederlands 74
3

4
ENGLISH
ENGLISH

5
I- BASIC FEATURES 6
II- INSTALLATION 8
III- RECOMMENDATIONS FOR USE 8
IV- USE 11
V- MAINTENANCE 12
VI- TROUBLESHOOTING 13
VII- TECHNICAL
CHARACTERISTICS 15
C ONTENTS

I - BASIC FEATURES
The SERVOTOME®is a high-frequency current generator
used for the incision and coagulation of soft gingival
tissue thanks to a wide range of electrodes.
1. 1 GENERAL CHARACTERISTICS
- Incision by high-frequency current
- Coagulation by pulsating current
- Status displayed by indicator lamps plus audible
signal
- Power control button
- Coagulation control button
- Control by footswitch.
1. 2 ITEMS DELIVERED
- One SERVOTOME®device
- One footswitch and lead
- One removable mains lead with earthed connection
- One electrode-holder
- One electrode-holder cord
- One capacitive coupler (back plate)
- One box containing 10 electrodes
- One user's manual
- Setting instructions.
1. 3 GENERAL VIEW
Refer to the illustrations at the end of this manual.
6
1Rear Panel 6Electrode-holder
2Indicator Lamps 7Electrode-holder rest
3Power Control
Button 8Electrode-holder cord
4Coagulation Control
Button 9Footswitch
5Capacitive coupler

1. 4 FRONT PANEL
This comprises two indicator lamps and two control
buttons.
• "Active" Indicator Lamp (10)
This yellow indicator remains lit as long as the
footswitch is pressed and indicates the presence of
the high-frequency current. Note that a buzzer
sounds while the footswitch is being pressed.
• ON Indicator Lamp (11)
This is green; it lights up when the ON/OFF switch
(16) of the device is ON.
• Button (12)
Minimum to maximum incision power setting. At
maximum power (setting 10), the power delivered is
50W; this does depend, however, on the operating
conditions and the histological variables.
• Button (13)
Coagulation Control:
- Value 1: Minimum coagulation
- Value 10: Maximum coagulation.
1. 5 REAR PANEL
• Capacitive coupler Connector (14)
Connection to the capacitive coupler: please refer to
"Recommendations for use" for the position of the
capacitive coupler.
• Footswitch Connector (15)
Connection to the single footswitch.
• ON/OFF Switch (16)
Position I: ON
• Fuse Housing (17)
Contains the fuses designed to protect the unit.
• Mains Plug (18)
Connection to the mains by a standard plug.
1. 6 SINGLE FOOTSWITCH
Pressing the footswitch (9) activates the high-
frequency output.
1. 7 CAPACITIVE COUPLER
The capacitive (5) capacitive coupler connects to the
device by a lead and returns the high-frequency
current. It should be placed on the clothed patient's
back (scapula).
7

II - INSTALLATION
2. 1 RECOMMENDATIONS
For your safety, connection to the electrical circuit
should be carried out by an approved dental
installation engineer.
Important: before using the device for the first time,
clean, decontaminate and sterilize the accessories
(in particular the electrode-holder and the
electrodes). See Section 5 - Maintenance.
2. 2 SETTING UP THE EQUIPMENT
- Place the device where it is to be used, on a level
surface or on one that has a slope of less than 10º.
- Plug in the electrode-carrier cord (8).
- Connect the footswitch (9) to the footswitch
connector (15).
- Connect the capacitive coupler (5) to its socket
(14).
- Connect the mains plug into the mains socket (18).
It is essential for the mains socket to be earthed.
III - RECOMMENDATIONS FOR
USE
3. 1 GENERAL RECOMMENDATIONS
Before the SERVOTOME®is used for the first time, it is
essential to carry out tests on anatomical parts
(pieces of meat - ideally, a piece of beef heart,
chicken breast, etc.) to determine how they react to
incision and to help adopt the right clinical procedure
(electrode movement speed). Repeat these exercises
as many times as necessary.
3. 2 THE DEVICE
Make sure the device is properly plugged in and
insulated. Use of the mains socket with its earthed
connection is mandatory.
The user should check the accessories and leads
regularly so as to locate any insulation fault and
replace them if and when necessary.
Do not use the device if it appears to be defective in
any way.
In the event of a malfunction, you are advised to
contact your SERVOTOME®supplier rather than an
official repairs technician.
3. 3 ELECTRODES AND ELECTRODE-HOLDERS
It is essential to replace used or damaged SERVOTOME®
accessories with the appropriate new SATELEC
accessories.
To avoid damaging or burning out the SERVOTOME®, it
should not be used with any accessories other than
those supplied by SATELEC.
Prior to each use, the electrodes and electrode-
holder must be cleaned, decontaminated and
sterilized.
8

The electrode-holder cord must be placed so as to
avoid any contact with the patient or other
conductors.
Active electrodes that are not being used temporarily
must be kept well away from the patient.
The patient should never come into contact with
metal parts connected to the earth (operating table,
support, etc.).
Contact between the practitioner's skin and that of
the patient should be avoided.
Simultaneous use on a patient of a monitoring device
equipped with needle electrodes and an electro-
surgical device is not recommended; if the need
arises, the electrodes in the monitoring device must
be placed as far as possible from the electro-surge
electrode.
Monitoring systems that include high-frequency
current limiters are recommended.
During surgical procedures in which the high-
frequency current could flow through parts of the
body with a relatively small straight surface section,
the use of bipolar methods may be desirable in order
to avoid unwanted coagulation.
3. 4 CAPACITIVE COUPLER
Make sure that the entire surface of the capacitive
coupler is in contact with the patient's clothed body.
The capacitive coupler should be placed between the
dental chair and the clothed patient.
The entire surface of the capacitive coupler should
be connected as near as possible to the operating
area, so that the current's shortest path between the
active electrode and the capacitive coupler is not via
the heart.
3. 5 OUTPUT POWER
The output power must be the lowest possible for the
purpose required.
Abnormally low power can be caused by a bad
capacitive coupler connection. Before increasing the
power, the operator should check the connections of
the different electrodes.
The power level delivered by the SERVOTOME®may vary
according to numerous parameters (operating speed,
histological variables, thickness and material of
clothing, etc.).
A malfunction may cause an abnormal increase in the
output power.
3. 6 ENVIRONMENT
Due to the high-frequency rays, there may be some
disturbance caused to other electrical equipment
when the SERVOTOME®is in use.
The SERVOTOME®is not designed to function in the
presence of an anesthetic gas.
The operator must be made aware of the risks
involved in the use of high-frequency equipment
when flammable gases are used (explosion hazard).
For patients and/or users carrying a pacemaker or
any other active implant, there is a potential risk due
to possible interference affecting the pacemaker or
damage to it. If there is any doubt, seek the advice
or approval of suitably qualified persons.
9

Certain body cavities and/or certain oxygen-charged
materials such as cotton, wool and gauze can be
ignited by sparks produced during normal use of the
SERVOTOME®.
3. 7 CONTRAINDICATIONS
The SERVOTOME®should not be used:
• in the presence of patients or practitioners carrying
active implants such as a pacemaker without the
advice or approval of suitably qualified persons.• in
the presence of a flammable anesthetic gas.
• with any accessories other than those supplied by
SATELEC.
Do not check to see if you have a high-frequency
current by producing electric arcs on metal
components.
The SERVOTOME®is not designed to withstand
defibrillator discharges.
The user should not attempt to repair or modify the
unit without prior SATELEC authorization.
3. 8 ADDITIONAL INFORMATION
This information is intended to acquaint the operator
with the limitations of electro-surgery.
- Unruly, emotional or excessively nervous patients
- Incomplete anesthesia
- Delicate surgery (mucoperiosteal surgery, grafts,
etc.)
- Very fragile tissue
- Ignorance of the theory of electro-surgery
- Lack of practice on anatomical parts
- Ignorance of the patient and of his/her general
condition
3. 9 LIABILITY
The manufacturer may not be held liable in any of
the following cases:
- Failure to follow the manufacturer's
recommendations at the time of installation (mains
voltage)
- Work including repairs carried out by persons not
approved by the manufacturer
- Use of electrical equipment that does not comply
with the regulations in force
- Any use other than the uses specified in this manual
- Failure to comply with the requirements specified
in this manual
The manufacturer reserves the right to modify the
unit and/or amend the user manual without prior
notice.
10

IV - USE
Use of the SERVOTOME®is restricted to capable
qualified practitioners (dental surgeons) and then
only in a dental surgery.
Prior to initial use:
- Clean, decontaminate and sterilize the accessories
(in particular the electrode-holder and the
electrodes). See section entitled Maintenance:
Sterilization.
- Perform tests on pieces of anatomy (pieces of meat
- ideally, a piece of cow heart, chicken breast,
etc.).
4. 1 MOUNTING THE ELECTRODE
1- Unscrew the electrode-holder cap (21) a few
turns.
2- Insert the appropriate electrode (19) for the
operating procedure.
For the choice of electrode, refer to the
document entitled Servotome® Clinical
Instructions.
Important: Do not use an electrode if its plastic
sheath looks damaged (splits, holes, etc.) or is
missing. Replace the electrode. It is essential to
push the electrode well in so that no metal part
is visible between the electrode-holder cap and
the electrode's plastic sheath (20). Any visible
part would cause the current to flow and result in
a painful incision in the wrong part of the
patient's mouth.
Replace the electrode-holder if it no longer holds
the electrodes tightly.
3- Screw the cap back on again (21).
4. 2 START-UP
1- Place the capacitive coupler (5) between the
chair and the patient's back (scapula).
Follow the indication "Patient Side" printed on
the capacitive coupler (22). Check to make sure
the capacitive coupler is in position on the
patient's scapula.
Important: the capacitive coupler does not need
to be in direct contact with the patient's skin. It
is essential that you refer to the section entitled
"Recommendations" before proceeding.
2- Turn the mains switch (16) to the ON position (I).
The green indicator lamp (11) opposite lights up.
The device is on and ready for use.
3- Adjust the incision power ( button, 12) and
coagulation ( button, 13) settings before
operating, to avoid a burn or other undesirable
effect.
Important: It is essential that you refer to the
section entitled "Recommendations" before
proceeding.
11
ELECTRODE SECTION SECTION + MIN. TO MAX. COAGULATION COAG. FULG.
=1 =2 =4 =6 =8 =10 =1 =1
I22S I22CA =3 =3/4 =3/4 =4/5 =5/6 =5/6
TR22T TR22R TR22L =4 =4/5 =4/5 =5 =5/6 =6
I40S I40CA =3/4 =3/4 =4 =4 =5/6 =5/6
FC10N =5/6
FC25B FC32B =5 =6/7
= Power (values provided for information only) = Adjustment of coagulation (values provided for
information only)

4- Press the footswitch (9). Incision is activated
immediately. The orange indicator lamp (10)
lights up and the buzzer sounds. The indicator
lamp goes out when the footswitch is released.
Important: The device should not be used for a
period exceeding 10 seconds, following which it
should remain inactive for 30 seconds before the
operation can be continued.
4. 3 COMPLETE SHUT-OFF
Turn the ON/OFF switch (16) to 0.
V - MAINTENANCE
5. 1 CLEANING THE CASING
It is not advised to use cleaning products or
disinfectants that contain flammable agents. If they
do however, make sure the product evaporates and
that no traces of the combustible agent remain on
the device or its accessories (electrode-holder,
electrodes, leads, etc.) when starting it up.
5. 2 ELECTRODES AND ELECTRODE-HOLDER
a) Cleaning the Electrodes
Use alcohol or disinfectant towelettes. Remove any
fragments of tissue that may have stuck to the
electrodes.
b) Cleaning the Electrode-holder and the Cord
These can be cleaned and disinfected using alcohol or
disinfectant towelettes. Make sure the product has
evaporated completely. The hollows in the screw
thread can be cleaned with cotton wool soaked in
alcohol.
Do not attempt to clean the electrode-holder in an
ultrasonic tank.
c) Decontaminating the Electrodes
Soak the electrodes in a glutaraldehyde or
quaternary ammonium alkaline solution for
approximately 20 minutes depending on the
concentration (see manufacturer's instructions).
5. 2 STERILIZATION
The cord connecting the electrode-holder to the
SERVOTOME®cannot be sterilized.
It is essential to sterilize the electrodes and the
electrode-holder before each use.
12

Requirements and sterilization cycle according to the
equipment:
- Equipment: autoclave
- Wet heat sterilization: 134ºC at 2 bar (200 KPa) for
18 minutes
Important: metal parts of different types should not
touch one another during sterilization. Any such
contact would produce electrolytic couples that
would cause local damage. To avoid this
phenomenon, place the objects in a cloth or a micro-
porous sterilizing bag.
5. 3 FUSE REPLACEMENT
Proceed as follows:
1- Turn the ON/OFF button to "O" (23) and unplug
the mains lead from its socket (24).
2- Insert the tip of a screwdriver into the notch (25)
to open the protective cap.
3- Replace the fuses (26) with fuses of the same
rating and type.
4- Push the fuse compartment back into its housing.
The SERVOTOME®designed by SATELEC is a medical
device of class IIb (European Directive no. 93/42/EEC
concerning medical devices; Transposition to the
French national legislation by Decree no. 95/292 of
16/03/1995).By application of the French Decree of 5
December 2001 and the corresponding Order of 3
March 2003 concerning the obligation to ensure
proper maintenance and quality control of medical
devices, the operator -who is responsible for due
implementation of the applicable maintenance
operations, is invited to refer to, and to apply the
maintenance operations as introduced in the
following standards:
CEI 1289-1: High-frequency surgical equipment - Part
1: Operation
CEI 1289-2: High-frequency surgical equipment - Part
2: Maintenance.
VI - TROUBLESHOOTING
Please refer to the table on the following page
13

14
FAULT POSSIBLE CAUSE CORRECTIVE ACTION
Nothing working;
the green
indicator lamp
doesn't light up
The ON/OFF switch is on O Turn the ON/OFF switch to I
Mains lead not properly connected Check the mains plug
No electric current Check electric current supply
Fuse(s) not working
Change the external fuses. Caution: the unit includes a
third, internal, fuse that is inaccessible to the user.
Contact the dealer
The green
indicator lamp
lights up but the
orange indicator
lamp does not,
and the buzzer
does not work
Footswitch lead not properly
connected Check the footswitch: plug in firmly
Faulty footswitch Replace the footswitch or contact the dealer
Thermal protection of device Wait for the device to cool down
The indicator
lamps come on
and the buzzer is
working, but
there is no high-
frequency
current
Electrode-holder not properly
connected
Check the electrode-holder cord:
- Push unit-side connector in properly
- Push electrode-holder-side connector in properly
Capacitive coupler not properly
connected
Check the capacitive coupler: the connector must be all
the way in
Other possibilities Contact the dealer
The electrode
incises with
difficulty or is
not incising at
all
Capacitive coupler in the wrong
position.
Follow the indication Patient Side printed on the
capacitive coupler.
Make sure the entire surface of the capacitive coupler is
in contact with the lightly- clothed patient, for example,
on the scapula.
Soiled electrode Set the unit to O. Clean the electrode.
Electrode moving too fast Reduce operating speed
Unsuitable electrode Select the appropriate electrode for the operating
procedure
Electrode worn Replace the electrode
The electrode
sticks to the
tissue
Power set too low Increase power up to the incision threshold. There is no
need to go beyond this threshold
Inappropriate electrode Select the appropriate electrode for the operating
procedure
The electrode
incises but there
are sparks
Incision power set too high Reduce incision power down to the threshold. There is no
need to go beyond this threshold

VII - TECHNICAL
CHARACTERISTICS
7. 1 INPUT POWER
230 V AC ±10% or 115 V AC ±10%
Frequency: 50 to 60Hz
Power Consumption: 230 VA
7. 2 OUTPUT POWER
See output power curves below.
7. 3 WORKING CHARACTERISTICS
Monopolar mode bi-terminal technology.
Output power: 50W max. at 375Ωimpedance.
Useful output impedance range: 50Ωto 2KΩ.
Output frequency: 1.8 MHz ± 0.7 MHz.
Appliance Class 1 Type BF.
Incision and coagulation settings: 1 to 10.
Maximum output voltage: 725 V peak-to-peak @
P =10, W =1.
7. 4 PROTECTION
Two 5mm x 20mm time-delay fuses:
2 x 1.25 AT for the 230 V AC model or
2 x 2 AT for the 115 V AC model.
One 5mm x 20mm internal time-delay fuse: 500 mAT
ref. F1 on the printed circuit (not user-accessible).
Thermal protection in the event of intensive use
and/or non-compliance with the working cycle (10
seconds ON / 30 seconds OFF).
7. 5 USER INTERFACE
ON/OFF switch on rear panel.
Output power control button, settings 1 to 10.
Coagulation control button, settings 1 to 10.
Tight footswitch control switch.
Green ON indicator lamp.
Yellow indicator lamp and buzzer (65dB min. at 1
meter) of HF signal.
7. 6 CONNECTORS
6.35mm capacitive coupler jack connector.
4mm electrode-holder cord safety connector.
7. 7 DIMENSIONS AND WORKING CHARACTERISTICS
Overall dimensions:
- Width: 250mm
- Height: 110mm
- Depth: 240mm.
Weight: 1.2kg.
Fixing: table unit on a level surface, slope not to
exceed 10º.
Working temperature : 10 to 40°C
Working relative humidity: 30 to 75%
Storage/transport temperature: - 40 to +70°C
Storage relative humidity: 10 to 95%.
15

7. 8 SYMBOLS AND MARKING
7. 9 STANDARDS
Manufactured in accordance with the regulations and
standards in force.
European Directive CE 93/42/EEC
IEC 601-1.
IEC 601-2-2.
7. 10 DISPOSAL AND RECYCLING
The SERVOTOME®and its accessories can only be
disposed of by an authorized collector of electronic
devices or by returning them to the SATELEC After
Sales Department.
Under no conditions should the Servotome and its
accessories be disposed of by the user.
NB: SATELEC will provide the technical staff of
authorized SATELEC dealers upon request with all the
necessary information to carry out repairs to parts of
the device that SATELEC deems reparable.
The use of the WEEE symbol indicates that this
product must not be treated as household waste, but
must be treated separately, in conformity to the
Directive 2002/96/CE. By ensuring this product is
disposed of correctly, you will help to protect the
environment. For more detailed information about
the recycling of this product, please contact your
local authority, your house waste disposal service
provider or where you purchased the product. At the
end of their life, tips should be discarded in safety
containers designed for this purpose
7. 11 MANUFACTURER ID
SATELEC - ACTEON GROUP
17, avenue Gustave Eiffel
BP 30216 - F - 33708 MERIGNAC cedex
Tel: (+33) (0)5 56 34 06 07
Fax: (+33) (0)5 56 34 92 92
[email protected]
www.acteongroup.com
16
Symbols Meaning
Alternating current
BF type appliance
Caution! Refer to accompanying documents
Capacitive coupler connector
Footswitch connector
Not to be disposed of as household waste
Earth-referred capacitive coupler for HF currents
CE marking in accordance with Directive 93/42/EEC
230V : 2x1.25 AT
115V : 2x2 AT Primary fuse rating depending on mains supply
Power setting control
Coagulation setting control
IP21 Degree of protection afforded by the casing

7. 12 OUTPUT POWER CURVES
17

18
FRANÇAIS
FRANÇAIS

19
I- PRÉSENTATION 20
II- INSTALLATION 22
III- RECOMMANDATIONS
D'UTILISATION 22
IV- UTILISATION 25
V- ENTRETIEN-MAINTENANCE 26
VI- ANOMALIES DE
FONCTIONNEMENT 27
VII- CARACTÉRISTIQUES
TECHNIQUES 29
S OMMAIRE

I - PRÉSENTATION
Le SERVOTOME®est un générateur de courant à haute
fréquence, permettant la coupe et la coagulation des
tissus gingivaux mous, grâce à une large gamme
d'électrodes.
1. 1 CARACTÉRISTIQUES GÉNÉRALES
- Coupe par courant à haute fréquence.
- Coagulation par courant pulsé.
- Affichage de l'état par voyants et signal sonore.
- Bouton de réglage de la puissance.
- Bouton de réglage de la coagulation.
- Commande par pédale.
1. 2 ELÉMENTS LIVRÉS
- Un SERVOTOME®.
- Une pédale de commande avec son cordon.
- Un cordon secteur amovible avec une prise de
terre.
- Un porte-électrodes.
- Un cordon pour le porte-électrodes.
- Un coupleur capacitif.
- Un coffret de 10 électrodes.
- Un manuel utilisateur.
1. 3 VUE GÉNÉRALE
Se référer aux illustrations localisées à la fin de ce
manuel.
20
1Face arrière 6Porte-électrodes
2Voyants 7Support porte-
électrodes
3Bouton de réglage
de la puissance 8Cordon du Porte- électrodes
4Bouton de réglage
de la coagulation 9Pédale
5Coupleur capacitif