Professional Documents
Culture Documents
Electrosurgical Generators
SURGILEC MC 2
User Guide
Notice ref : SURGILEC MC2 -NU 0105N001 UK
LAMIDEY NOURY MEDICAL Z.A. Les Godets - 3, rue des Petits Ruisseaux
91370 Verrières-Le-Buisson (France)
Tél : (33) 01.69.20.30.21 - Fax : (33) 01.60.13.97.47
E-mail: info@lamidey-noury.fr
SURGILEC MC2 User guide
IMPORTANT
The instructions herein are the integral part of the high frequency surgical apparatus that you have just
purchased.
They describe the functions of the generator, and must be read carefully before installation and usage.
All the security regulations and warning notices must be scrupulously observed. Make sure that all
members of the surgical team are fully aware of the hazards; understand the principles of the operations and
of the safe handling. No part of this document can be photocopied, reproduced or translated without prior
written consent from LAMIDEY-NOURY MEDICAL. In case of need please contact the Technical assistant.
INDEX
1. INTRODUCTION
1.1. Field of Application.
1.2. Accessories description and compatibility warnings.
1.3. Definitions.
1.4. General description.
1.5. Monopolar Cut.
1.6. Monopolar coagulation.
1.7. Bipolar coagulation.
2. RECEPTION OF THE APPARATUS.
2.1 Reception delivery control.
2.2 Installation of the generator.
2.3 Control before using.
3 PRECAUTIONS AND GENERAL HINTS.
3.1 Instructions for using the High frequency power electro surgery apparatus.
(Meets requirements, standards NF EN 60601-2-2)
3.2 Additional information.
3.3 Advice on the correct plate positioning.
4 CONNECTIONS AND CONTROLS.
4.1 Symbols and pictogram.
4.2 Back panel.
4.3 Front panel.
5 INSTRUCTIONS.
5.1 Starting, alarm patient plate.
5.2 Monopolar cut mode.
5.3 Monopolar coagulation mode.
5.4 Bipolar coagulation mode.
6 ADJUSTMENT AND POWER ACTIVATION.
6.1 H.F.power settings.
6.2 Double foot pedal activation.
6.3 Hand held tactile pencil activation.
6.4 Manilec bipolar forceps activation.
6.5 Audible indicator setting.
6.6 Does and don’ts
6.7 Inert gas activation.
7 TROUBLE SHOOTING
7.1 Unit responds to controls.
7.2 No response from the controls.
7.3 Generator alarm sounds
8 MAINTENANCE.
8.1 Generator.
8.2 Accessories and instruments.
8.3 Service.
9 TECHNICAL SPECIFICATIONS.
9.1 Mechanical and environmental specifications
9.2 Input specifications
9.3 Output specifications
10 Appendix.
1 INTRODUCTION
1.1 Field of application.
The Surgilec MC2 generators utilisation is reserved for qualified surgeons. This electrosurgical
unit is to be used intermittently for the surgical operations in the operating theatre.
Used for the following surgical procedures:
Specialties
Out-patients surgery
References Description
11SM2F Watertight foot pedal bi-circuit for mono and bipolar operations
11K250 Connection cable, disposable length 5m for patient adhesive plate
PLAD2, PLEN2, Adhesive patient split-plate, disposable for adult and child
PLAD2K2, PLEN2K2, Adhesive patient split-plate, disposable for adult and child with cable
11FM40 Cable for foot pedal monopolar forceps operations, sterilizable
11MD25, 11MD40 DERLEC, pencil without cable, foot pedal operation (2-2.4mm or 4mm)
11MC254, 11MC404 DERLEC, Pencil with cable 4m inclu. f.p. operation (2-2.4mm or 4mm)
11MCT9, 11MCT94 TACTILE hand switches pencil, reusable, with cable 4m inclu. (2-2.4mm or 4mm)
SUT1, SUTL1 Tactile hand switch pencil, disposable, with electrode needle, 7cm or 15cm
SUC1, SUCL1 Tactile hand switch pencil, disposable with electrode blade, 7cm or 15cm
SUT2, SUC2 Pencil, foot pedal operation, disposable with electrode needle or blade, 7cm
1.2.2 Compatibility
Warning: The specification CE mark on the electro surgery accessories don’t guarantee
compatibility with all other generators on the market.
The safety of the patient and the user relies not only on the generator, but also on the
accessories and how they are applied, especially in the case of pedals, plates, electrodes and
pencil holders and their conductors. These have been the object of research, tried and tested to
which the data specifications comply with the CE mark. It is therefore important to utilize the
equipment and accessories, supplied or recommended by the manufacturer, by which the
compatibility with the generator can be proven and certified by the manufacturer or an approved
organization.
In accordance with the norm NF EN 60 601-1(network frequency insulation) regarding the
accessories connected to the patient must be 1500Vrms Minimum.
In accordance with the norm NF EN 60 601-2-2 the electrode cables must resist to a 3000V
network frequency tension, all the pencils, forceps and connector cables, must be insulated HF +
or - 1.5 times the maximum HF output of the generator (on the corresponding outlet)
WARNING: THE USE OF ELECTROSURGERY ACCESSORIES INSUFFICIENTLY ISOLATED RUN
THE RISK OF BURNING, FIRES AND SURGICAL INJURIES.
In accordance to the paragraphs 6.8.2. - (b) of the norm NF EN 60601-1 regarding the security of
the medical electrical equipment, the manufacturer can be held responsible for the effects on the
security, reliability, or the specifications of the equipment or accessories, only if:
- The settings, modifications or repairs have been carried out by the manufacturer or persons
authorized by the manufacturer.
- The electrical installation of the surgical premises, apply within the specifications of the I.E.C.
- The equipment and accessories are used according to the manufacturer’s instructions.
1.3 Definitions
High frequency power: the electrosurgical unit is a HF power generator, according to the norm
NF EN 60 601-2-2, mains voltage output of the electrosurgical generator must be superior or
equal to 300 kHz.
Active electrode: the active electrode is a contact electrode in which the HF power is converted
into thermal energy to obtain the cutting and coagulation effects. The active electrode is often
presented in the form of needles, blade, ball or resection loop.
Neutral electrode: the neutral electrode is an electrode with a large flat surface, placed on the
patient which completes an electrical HF circuit, without producing thermal change. This electrode
is also called an electrode patient plate or dispersive electrode.
Monopolar mode: The application of this mode is when the HF electric current is dispersed
through the patient between the active electrode and the neutral patient plate electrode.
Bipolar mode: The application of this mode is when the HF electric current HF is dispersed
through the biological tissues situated between two active electrode tips; the bipolar electrodes
are represented by two jaws of a bipolar forceps
1.4 General descriptions.
The HF power SURGILEC generators are primarily used to obtain a cut or coagulation
(haemostasis), by monopolar or bipolar mode.
The current can be constant during all the operation time from the output circuit, through the
active electrode in monopolar mode or through two active electrodes in bipolar mode.
It is possible to use with the SURGILEC generators, the neutral electrode return plates, a
single or the two sectioned split plate, recommended with monopolar mode.
The Mains power supply is situated at the back of the generator and the power setting touch
controls and visual indicators are found on the front panel.
The automatic control system of the internal parameters, signals all abnormalities.
The last power settings used, are automatically remembered when powered-up. The last
operational settings are also automatically remembered in the case of a power failure which lasts
for less than 20 minutes. If the power failure is more than 20 minutes, it is advised to verify the
last operation selected.
The audible activation indicator is adjustable, so that each user can choose the level desired.
The generator functions with the tactile hand switch pencil or the pencil holder pedal
operation.
1.5 Monopolar cut
The monopolar cut consists of cutting the biological tissue by passing the HF, high-density
current through the active electrode. When the HF current is applied on the tissue by the tip of the
active electrode, this generates intensive heat which bursts the cellule.
The cutting effects are obtained when placing the electrode on the tissue and destroying
therefore the cells one after another. The electrode movement avoids the heat spreading deeper
into the tissue, limiting therefore cell destruction on fine tissue.
The current the best adapted for the cutting, is the pure sinusoidal, without any modulation,
because it makes a very neat cut in producing a reduced amount of thermal and haemostasis
effect. This particular setting allows the user, full security without any necrosis of the surrounding
tissues.
A good coagulation during the cut is one of the principle advantages of the electro surgery;
therefore it is preferable to use a current with a given operating mode, called power haemostatic
cut.
The following indications will help the surgeon to obtain the correct incision:
• Utilise the electrodes: type needle or fine blade ( cutting edge ),
• Keep the tissue humid but not wet,
• Hold the electrode perpendicular to the tissue to be severed,
• Don’t start cutting until the electrode is in contact with the tissue,
• Keep the electrode very clean ( use the electrode scraper pad )
The correct output power allows to not have,
• Any resistance of the movement on the electrode when in contact with the tissue,
• No burning of the cut surfaces,
• No sticking tissue on the electrode.
The generator must be placed on a flat, stable surface, at least the same size as the
apparatus, with an area around the apparatus of no less than 25cm. if the unit is placed in an
enclosed area the volume must be no less than 1m3 with protective heat resistant walls.
The stand for the generator must be able to support the weight (see § 9.1) LAMIDEY NOURY
MEDICAL recommend their stainless steel trolley, 2 plateau, without drawers (ref.10GST1) and 2
plateau, with one drawer (ref.10GAT1).
Connection details are described in chapter 4: “Connections and Controls.”
Insert the power cable into the connection at the back of the unit.
Connect the equipotential connection to the area shown at the back bottom left of the unit
with the power supply cable plug (connection optional).
Utilization of the pedal, connect to the appropriate connection at the back of the unit.
Utilization of the hand switch tactile, connection on the front of the unit, the pencil without
controls, connects to the red socket.
Utilization of the bipolar forceps, connect to the socket bipolar.
Before using the unit, it is necessary to place the patient plate on the patient then connect to
the generator. The patient split- plate double and single plate can be used. If the impedance
between the electrode and the skin exceeds certain critical limits, the alarm will sound and stop
the production of the power. (See § 3.3 Advise and 5.1 Activation.)
2.3 Control before using
For the security, a daily general control of the generator and accessories before the first
operation in the day will prevent any possible malfunctions or breakdowns.
2.3.1 Accessory check
Before each operation, assure that all accessories to be used are within easy reach and sterile.
The electro surgery accessories undergo ineluctable wearing, due to mechanical and chemical
factors. Accidental deterioration (knocks, falls, etc…) can happen, therefore a careful visual and
testing check must be conducted before use.
Accessories that show visual signs of wear and tear must not be used, notably – changing of
the accessories shape or connection plug or faulty insulation cables. Excess pulling on the cable
will provoke strain, therefore eventual damage at the mains. Damaged cables must be replaced.
It is possible to test the foot and manual controls, after having adjusted the HF power to “0”.
Press the button on the Yellow cut area (foot control lever) or by pressing the button on the blue
coagulation area (foot control lever) the alarm will sound to show the good working function.
With the accessory TESTELEC (ref. 11VTES), this tests the working function of the controls and
the cable power flow.
WARNING: USING FAULTY ELECTROSURGERY ACCESSORIES, YOU RUN THE RISK OF BURNES,
FIRE RISKS AND MEDICAL INJURY TO YOURSELF, THE PATIENT AND YOUR MEDICAL STAFF.
2.3.2 Generator control
Before the first operation of the day, it is advisable to do a quick visual generator control,
check that the unit is earthed. If the apparatus shows any signs of damage, like knocks or if there
is any deterioration of the connection plug, the unit must not be used, only after verification of the
part or a maintenance control approved by LAMIDEY-NOURY MEDICAL.
• Connect to the patient, a patient plate or a jack plug test ref: 11VJ33.
• Turn the unit on, by precaution do not connect any active electrode with the unit.
• While separating the neutral electrode plate from the cable, check the alarm display
(sounding alarm and visual monitor)
• Check that the digital display lights are on.
• Connect the twin pedal footswitch or the pencil tactile.
• Select the monopolar mode.
• Start up successively the operation cut (yellow lever on the double foot pedal or the yellow
button on the hand switch) and the coagulation operation (blue lever or blue button): the
corresponding yellow and blue lights should light up; this produces a two tone warning sound.
• Adjust the HF power to 0, the indicator HF ENERGY during the operation cut and coagulation
should be unlit.
• After, adjust the cut and coagulation power to the maximum level. During the activation of
each function, the indicator HF ENERGY should be lit-up.
• Select the bipolar mode and repeat the same tests as for monopolar mode with the double
pedal operation. The bipolar cut operation will not function.
• Readjust the power levels compatible with the operation to be carried out.
c1 - The NEUTRAL ELECTRODE PATIENT PLATE must be firmly attached onto the surface of
the patient, and as near as possible to the operating site.
See the §3.4 How to use the neutral electrode plate.
c2 - The PATIENT must not be in contact with the grounded cables or anything in contact
with the ground (for example, operating table, support, etc…). The utilization of antistatic
wrappings is advised.
A common risk is the conduction of the HF current via a fluid. There must not be any fluid
which could make an electric conduct between the patient and the operating table. For that, the
table can be re-covered with a dry surgical sheet or a water-proof under sheet. Check also that
the patient is not excessively painted with antiseptic fluid. The high perspiration areas must be
kept dry.
c3 - The skin to skin contact between the arms and the body of the PATIENT for example,
should be avoided; place dry gauze.
c5 - The electro surgery electrode cables, must be placed in a way that there is no contact
with the patient or with other conductors and not to be re-covered around the operating site.
To reduce the risk of interference, avoid positioning the HF cable near to the endoscope camera
cable, for example
.It is recommended to place the ACTIVE ELECTRODES between uses, away from the patient.
In fact, there is a risk of burns to patients, if the electrode is accidentally activated or if the
electrode has not had the time to cool down before being put down. Using a well-insulated sterile
safety holster will protect against these risks.
c6 - For the surgical operations on the parts of the body having small confined surfaces, the
use of the bipolar technique is preferred to, in order to avoid undesirable coagulation.
In fact, if the electrosurgical current has to pass an area of confined tissue to the electrode
plate, the high-density in that area risks to coagulate or even burning, for example, in the case of
monopolar coagulation on a testicle, the HF current risks to burn the vas deferens in its path.
c7 - The selected power must be as low as possible for the required purpose.
c8 - A seemingly low power or a fault in the correct operation of the normal functional
settings of the apparatus could indicate an incorrect application of the NEUTRAL ELECTRODE or
the electrode cable is not connected. In this case, before increasing the power settings, the
application of the neutral electrode and connections must be checked.
c9 - The use of flammable anaesthetic, nitrous oxide (N20) and oxygen must be avoided
during the surgical operations on the thorax or the head, unless these agents can be evacuated by
aspiration or if the APPARATUS IS PROTECTED AGAINST THE ANAESTHETICS. It is advisable when
using flammable products (used for cleaning and disinfecting) and flammable solvents for
adhesive products the time to evaporate, before the surgical procedure. The fact that there is a
risk of accumulated flammable solutions under the PATIENT, in the creases or cavities of the body,
such as, the navel or the vagina, all accumulated fluids in this area must be cleaned away before
using the apparatus. The unavoidable electric arc which appears between the active electrode and
the tissue can in the presence of oxygen (contained in the air for example) cause the
inflammation of the endogenous gas. Therefore it is strongly recommended, especially when
operating on the abdomen, the neutralization of the atmosphere around the active electrode by
projecting inert gas (N2, C02,etc…) certain material like cotton wool or sterilized gauze, could
when it is saturated with an antiseptic, be set alight by the sparks produced by the apparatus
when used normally.
The electrosurgical generators must never be used in the presence of flammable liquid
or gas
The SURGILEC MC4 generator, on request, for the protection against the ignition of the gas
endogenous in digestive surgery, can be equipped with the system- projection of nitrogen (N2),
onto the active electrode.
c10 - For the PATIENTS fitted with a pacemaker or a stimulation electrode, there exists a
possible risk of interference to the function or damage to the pacemaker: the BIPOLAR mode is
advisable, if in doubt, refer to the cardiology department.
c11 - The electrosurgical unit’s are high frequency power generators. When the power supply
cables are connected to their terminal, they react like a short wave electromagnetic transmitter.
Other electrical equipment found within the operating theatre, monitors, camera, video etc… If
they have are not designed to function in these surroundings, can be affected by interference.
The ECG monitors can be fitted with special cables including a HF power filter with the inductance
category.
c12 - Although the specific circuit examines permanently, that the output power does not go
beyond 20% of the required setting and the loading value. It must not be forgotten that a serious
failure of the generator can increase the dangerous output power for the patient. In the case
where such an event is perceived, it is important before everything else is to cut the generators
power by operating the on-off switch and/ or disconnect the cable from the mains.
• When using HF power when using the active electrode submerged in a conductive liquid
like saline solution, presents the risk of burning by the overheating of the liquid. A device
capable of evacuating of the liquid must be used, such as the arthropump for the arthroscopy.
The electrode used must have a limited contact area with the fluid with high resistant
temperature sheathing, such as a ceramic sheathing. With the bipolar mode, it is possible to
coagulate tissue which is soaked in saline solution.
• Check carefully the accessories, in particular the cables, before being used, notably
ensuring their good insulation (cf. § 2.3.1).
• So that the correct accessories are compatible with the generator, we recommend to
compare their insulation specifications and those required by the apparatus (see technical
specifications of the generator § 9.3. and standard compatibility requirements § 1.2.2).
• Stimulation of the muscles or nerves of the patient could be caused by low frequency
power sparks between the electrode and the tissue of the patient. If this should happen, stop
immediately the surgical operation and control all the connections of the generator. If no fault is
found, consult a technician approved by LAMIDEY NOURY MEDICAL.
• Any contact with components which bring on a heart condition are to be avoided, if an
electrode catheter current conveys the HF current to the heart this can produce damage to the
cardiac tissue, like atrioventricular bundle or sinusal node.
• Using electrosurgical current on bone tissue risks periosteum damage and jeopardise the
cicatrisation, resulting in necrosis of the tissue.
• The electrical security of the generator is only guaranteed if it is correctly connected to the
power supply and grounded, and meets with the security standards. It is compulsory to check
these essential requirements. If not sure, a thorough control of all the electrical elements should
be undertaken by a qualified person. The manufacturer of the electrical HF generator can not be
held responsible for damage caused by incorrect grounding necessary to the installation. It is
therefore forbidden to proceed in using the apparatus which is not efficiently grounded.
• Before connecting the apparatus, be sure that the voltage (shown on the back panel)
corresponds with that of the mains.
• If there is an incompatibility between the power socket and the power cable, only replace
these with accessories and connectors which meet standard requirements. It is advised against
using extension adapters, multiplugs and extension leads of any type, but if there is no other
choice, make sure that the adapters conform to the standard security requirements.
• Never touch the apparatus with wet or damp hands and feet.
• Do not use the apparatus with bare feet;
• Do not leave the apparatus exposed to excessive light, heat and moisture.
• Do not block the openings; ventilation grill.
• It is prohibited to use the generator around an explosive atmosphere.
• Disconnect the appliance after use.
• When the surgeon has finished with a particular function (monopolar cut or coagulation
bipolar for example) it is recommended to reduce the power level to O.
• The generator must be used exclusively for the purpose in which it has been designed. The
manufacturer cannot be held responsible for damage caused by incorrect use,
• It is dangerous to modify, or to try to modify the specifications of the appliance...
• Before starting any cleaning or upkeep on the appliance, disconnect by removing the
power plug from its socket or switching off at the mains.
• Switch off the generator in case of damage or malfunction. Contact an approved after sales
service technician requesting original spare parts. Any other solution risks jeopardizing the
security of the appliance and particularly the user.
• Do not deactivate or reduce the audible activation indicator on the generator. The
activation alarm can minimize or avoid injury to the patient or the personnel in case of accidental
activation.
• Although the appliance has been conceived to function briefly on short circuit, avoid
checking the working order of the appliance by making a short circuit between the active
electrode and the neutral electrode plate or putting the active electrode in contact with metal
objects.
3.3 Advice on correct plate positioning.
The generator cannot be used without previously attaching the neutral electrode plate onto the
patient, to avoid all risks of patient plate contact burns, in monopolar mode, the following security
rules are essential:
3.3.1 Choice of the patient plate:
LAMIDEY-NOURY MEDICAL advice using exclusively the twin conductor split plate. The
disposable adhesive gel plates present the best security advantages against plate discharge and
the adhesive gel improves distinctly the quality of the conduction.
WARNING: USING SINGLE SURFACE PLATES, THE ALARM MONITOR CANNOT DETECT ANY
CONTACT FAULT ON THE PATIENT. ONLY THE USE OF THE TWIN CONDUCTOR SPLIT PLATE
ALLOWS THE GENERATOR TO WARN OF ANY EVENTUAL FAULT.
There exist 3 sizes, adult, child and baby. Whatever the size of the patient, the choice depends
on the surface required to attach the plate. If the size adult is too large for a child, try the child
size plate and if the child plate is too large for a baby, use 2 baby plates (with a double connector
UNIPLAC)
3.3.2 Positioning the plates.
To be sure of the best possible contact with the patient, certain safety measures must be
taken:
- The neutral patient plates contact must be perfectly fitted onto the body of the patient, to be
placed as near as possible to the operating site. The chosen area must be clean, dry, (removal of
all traces of cosmetics) and shaved. Do not use alcohol for cleaning the skin.
- The use of the adhesive neutral electrodes, pre-gelled are advised.
- Choose an area muscular or vascularised (thigh, buttock, abdomen, for example).
- Avoid the areas like body hair, scared tissue, bony areas, joints, metal prosthesis (ECG for
example), areas of the body where there is an accumulation of fluids. Avoiding the lumbar, the
sacrum, the ischium and the scapula areas.
The neutral patient plate’s surface contact must not be reduced by overlapping or by reducing in
size by cutting the plate.
Patient plates must not have any creases or bends. There must be no tissue between the
patient plate and the patient.
There must be no air bubbles trapped between the adhesive plate and the skin (press with the
hand along the length of the plate towards the connection clamp).
Patient plates must be placed as to avoid fluid between the plate and patient, amniotic fluid in
caesarean section, for example and to avoid liquid like iodine under the patient plate.
Do not add extra gel to the patient plate.
Do not remove and reposition the adhesive patient plate if the patient is moved during the
operation, check that the plates contact is correctly positioned.
Do not use the adhesive patient plate after the out of date stamp.
Respect the stocking temperature limit shown on the packaging.
Read with care the utilisation notice for the adhesive patient plates.
In the event of the patient plate (SEN) alarm activation, discard and replace patient plate and
connector.
If the output power of the generator seems to be low, do not increase the electrosurgical
current before carrying out a control of the installation of the patient plate.
3.3.3 Advice on how to use
The connector UNIPLAC with the adhesive neutral patient plate
The connector UNIPLAC is designed to be connected to the disposable adhesive patient plates,
single or double surface.
In the event of an alteration or deformation of any kind to the connector UNIPLAC, or bare
cable, carry out a visual control before being used so if need be the article can be replaced or
repaired.
The accessory tester TESTELEC checks the cable power continuity when the UNIPLAC is
connected to the single adhesive plate. The double surface patient plate can be monitored only
when connected to the generator and applied on to the patient.
With the baby plate, use the double connector UNIPLAC which doubles the contact surface.
To connect the patient plate, lift the protected security hand lock, plug-in completely the
patient plates snap connection strip and secure.
Important: the incorrect size of the snap connection strip or incorrectly fitted, can jeopardize
the function of the patient plate alarm system. There is a risk of burning if part of the strip
protrudes from the connection. Using an adhesive bandage to hold together the connections will
avoid disconnection in the event of pulling on the cable. Keep clean the connection clip and plug.
It is advisable to attach the patient plate at least two minutes before starting up the
generator, to give time for the adhesive gel to moisturize the skin.
The UNIPLAC connector does not contain latex. They must not be cleaned by ultrasound or in a
decontamination bath. Wash with soapy water or mild detergent. Rinse well in clear water and
dry, eventually by compressed air. Use only decontamination products for wiping. Do not use the
connector if the connection strip or plug is still wet. UNIPLAC connector is not autoclavable.
SILIPLATES
The SILIPLATES are reusable plates with a conductor which does not contain latex. In the
case, when using on a limb, it must be fixed with an adhesive bandage. The SILIPLATE C (simple
surface) can be used on both sides. The SILIPLATE D (double surface) can be used only on the
side separated by 2 areas. Using the other side is dangerous and forbidden.
Before using, carry out a visual check of the SILIPLATE. In the event of an alteration like
deformation or bare cables, the part must be changed or repaired. Check carefully the condition of
the SILIPLATE area before using. In the event of wear and tear on the surface showing metal, or if
the surface shows any creases or dents, the plate must be immediately discarded and replaced.
The TESTELEC tester allows checking the continuity of the cable of the SILIPLATE C. This
function on the SILIPLATE D is only possible when the generator is connected to the plate after
being applied on to the patient.
The SILIPLATES must be always kept clean and dry. Check that there are no traces of
antiseptic before using. Only use decontaminated wipes to clean thoroughly before using. The
SILIPLATES are not autoclavable.
Output circuits are floating. The parts to which they are connected can be in
direct contact with the heart of the patient. The vertical plates at each side
indicate that it is not necessary to disconnect the electrode patient plate when
applying a defibrillator.
The circuit specifications terminal plate is not grounded, the electrode patient
plate is not grounded due to the high frequency
The metal casing of the apparatus can be connected by the suitable cable with an
equalizing potential rod. (This symbol and connecting terminal is found at the back
of the apparatus.)
1 Switch on/off
2 Mains power input socket
3 Fuses
4 Equipotential socket
5 Description plate
6 Double foot pedal socket
NOTE: The serial number of the generator is shown on the description plate
5 INSTRUCTIONS
5.1 Starting, alarm patient plate
The electrical units are conceived to function with neutral electrode
conductors, the single patient plate (as shown) and the double patient
plate, split into two sections. Whichever plate is chosen the touch button or
N°12 can be found on the front panel.
Connect the patient plate to the connection socket N°11, shown on the front panel, pushing in
completely the jack socket finishing with the conductor SILIPLATE or UNIPLAC.
Output circuit are floating in low/high frequency (electrode patient plate not
ground-referenced): All electrical connections between the patient plate and the
operating table are forbidden.
Start-up the generator by pressing the switch on/off, found on the back panel. As soon as the
unit is powered, the units alarm plate will sound in the following cases:
When the single patient plate is connected:
If there is a fault in the electrical connection between the patient plate and the unit.
If the double patient plate function is selected.
When the double patient plate is connected:
If there is a fault in the electrical connection between the double patient plate and the
patient (incorrect contact)
If the impedance of contact between the patient skin and plate exceeds 60 Ohms, when
the single patient plate is selected.
When the unit alarm sounds, the power is stopped, therefore deactivated.
If there is a fault with the patient plate, only when selecting bipolar mode will the alarm stop.
ENDO-SECTION is a high modulated cut designed for a great haemostatic effect. Therefore
when the electrode is penetrating through the tissues, a coagulating phase precedes the cut.
ENDO SECTION is the best way for polypectomy in gastro-enterology.
UNDER FLUID CUTTING (TUR or myomectomy) requires higher power because of the calorific
diffusion in the fluid. In order to achieve priming capable to cut under fluid, it is imperative to
choose the pure cut. Check with the power indication table (appendix).
Cautions:
Do not pull the foot pedal by its cable.
The foot pedal can be cleaned and rinsed with running water; without immersion.
Only use a decontamination surface cleaner.
Check the foot pedal before using: if there is an adhesive pad missing under the foot
pedal, the controls risk to not function. To check the control system, the tester TESTELEC is
recommended or via the generator (see § 2.3.2)
7 TROUBLE SHOOTING
7.1 Response from the controls
7.1.1 – When the indicator [HF/ENERG] N°11 is lit up but the electrode stays inactive
when in contact with the patient: - Check that the monopolar/bipolar selection is correct. If the
selection is correct, check the working order of the accessories (connections, cables, electrodes
etc…), if need be, change them.
7.1.2 – When the indicator [HF/ENERG] N° 11 stays inactive, regardless of digital
display settings: The defect appears to originate from the generator, contact the manufacturer or
your authorized representative.
7.2 No Response from the Apparatus
7.2.1 –When the ON indicator does not light up:
Check the sockets, power cables and fuses. If a fuse needs changing, contact the manufacturer or
your authorized representative.
7.2.2 –When the ON indicator lights up: Check the controls (foot pedal, electrodes
pencils or forceps, socket and cables). If need be use the tester TESTELEC.
7.2.3 – If no anomaly is detected, do not attempt to remove the back panel, contact
the manufacturer who will assure the guarantee and is solely responsible for the service and
adjustments.
7.3 Generator Alarm Sounds
7.3.1 – Alarm Plate
If the alarm starts, with the red flashing light (S.E.N): check that the touch selection button
for the patient plate is correct. If the alarm continues, select the bipolar mode. If the alarm stops
this means that there is a fault, check the cables and connections.
8 MAINTENANCE
8.1 Generator
The generator needs no special maintenance apart from regular cleaning of the outer casing
and front panel with a soft clean cloth soaked in alcohol. For decontamination use a sterilized
cleaner.
8.3 Service
The generator requires no particular sanction before being commissioned. The casing must not
have been tampered with, unless authorized: as this will nullify the guarantee. To correct any
problems or servicing, contact or send the generator to the technical services department of
LAMIDEY NOURY MEDICAL, with full details of the problem encountered.
The maintenance consists mainly in the cleaning and sterilization of the accessories and the
checking of the good working order of the generator before being used. An annual security control
to check the settings must be done by a specialized technician.
LAMIDEY NOURY MEDICAL recommends an annual preventive maintenance intervention to
control the electrical specifications.
JOURNAL OFFICIEL de la République Française N°66 of 19/03/2003: signed order 3rd March
2003 from the French Department of Health making it an obligation to servicing the medical
devises class IIb.
Changing Fuses
If a power fuse has blown and needs changing, it must be replaced with the same wattage.
Therefore in this situation, we recommend that the generator should be checked before utilization,
as there may be a possibility that the generators power circuits might be at fault.
9 TECHNICAL SPECIFICATIONS
9.1 Mechanical and Environmental
Mobile Unit
- Fixed installation
- Installation on an arm
- Outer protection level: IP 203
- Dimension and weight:
Weight Width Height Depth
9 Kg 345 mm 190 mm 370 mm
- Fixed installation restrictions with the cooling system:
If the unit must be placed in an enclosed area the volume must be no less than 1m3.
9.2Input Specifications
Supply : 230 V 50 Hz
(1)
frequency modulation Crest factor
Monopolar pure cut 620 kHz 0 1.4
(1)
Crest factor: ratio between peak voltage and rms voltage (output unloaded)
10 ANNEXES
- Guidelines to Power Settings.