SEAL electrosurgical unit

Ref V10GMS

Instructions for use

EN : NU-SEAL.Rev1
Revision date: 2018/12/03

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
SEAL electrosugical unit Instructions for use

Summary
1. INTRODUCTION .........................................................................................................3
1.1. INTENDED USES AND CONTRAINDICATIONS..........................................................................3
1.2. LIST OF STANDARD ACCESSORIES - COMPATIBILITIES. ............................................................3
1.3. DEFINITIONS ............................................................................................................4
1.4. GENERAL DESCRIPTION. ...............................................................................................4
1.5. MONOPOLAR CUT ........................................................................................................5
1.6. MONOPOLAR COAGULATION............................................................................................5
1.7. BIPOLAR COAGULATION ................................................................................................5
1.8. BIPOLAR CUT ............................................................................................................5
1.9. VESSEL SEALING ........................................................................................................6
2. RECEPTION OF THE APPARATUS ..................................................................................6
2.1. RECEPTION DELIVERY CONTROL .......................................................................................6
2.2. INSTALLATION OF THE GENERATOR ...................................................................................6
2.3. Control before using ...............................................................................................7
3. PRECAUTIONS AND GENERAL HINTS............................................................................8
3.1. INSTRUCTIONS FOR USING THE HIGH FREQUENCY ELECTRO SURGERY APPARATUS (MEETS REQUIREMENTS
STANDARDS NF EN 60601-2-2) .............................................................................................8
3.2. ADDITIONAL INFORMATION ............................................................................................9
3.3. ADVICE ON CORRECT PLATE POSITIONING. ........................................................................ 10
4. CONNECTIONS AND CONTROLS ................................................................................ 13
4.1. SYMBOLS AND PICTOGRAM ........................................................................................... 13
4.2. BACK PANEL ........................................................................................................... 14
4.3. FRONT PANEL .......................................................................................................... 15
5. INSTRUCTIONS ....................................................................................................... 15
5.1. STARTING, ALARM PATIENT PLATE .................................................................................. 15
5.2. MONOPOLAR CUT MODE .............................................................................................. 16
5.3. MONOPOLAR COAGULATION MODE .................................................................................. 17
5.4. BIPOLAR CUT MODE ................................................................................................... 17
5.5. BIPOLAR COAGULATION MODE ....................................................................................... 18
5.6. VESSEL SEALING ...................................................................................................... 18
6. SETTINGS AND POWER ACTIVATION.......................................................................... 19
6.1. H.F. POWER SETTINGS ............................................................................................... 19
6.2. DOUBLE FOOT PEDAL ACTIVATION .................................................................................. 19
6.3. SINGLE FOOT PEDAL ACTIVATION ................................................................................... 20
6.4. HAND HELD TACTILE PENCIL ACTIVATION .......................................................................... 20
6.5. AUDIBLE INDICATOR SETTING ....................................................................................... 20
6.6. DOES AND DON’TS ................................................................................................... 20
6.7. INERT GAS ACTIVATION .............................................................................................. 20
7. TROUBLE SHOOTING ............................................................................................... 21
7.1. RESPONSE FROM THE CONTROLS .................................................................................... 21
7.2. NO RESPONSE FROM THE APPARATUS .............................................................................. 21
7.3. GENERATOR ALARM SOUNDS ........................................................................................ 21
8. MAINTENANCE ........................................................................................................ 21
8.1. GENERATOR............................................................................................................ 21
8.2. ACCESSORIES AND INSTRUMENTS .................................................................................. 21
8.3. SERVICE................................................................................................................ 22
9. TECHNICAL SPECIFICATIONS .................................................................................... 23
9.1. MECHANICAL AND ENVIRONMENTAL ................................................................................ 23
9.2. INPUT SPECIFICATIONS .............................................................................................. 23
9.3. OUTPUT SPECIFICATIONS ............................................................................................ 23
10. ANNEXES ................................................................................................................ 24

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SEAL electrosugical unit Instructions for use
1. INTRODUCTION

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. If necessary, contact our Technical support.

1.1. INTENDED USES AND CONTRAINDICATIONS

SEAL generators use is reserved for qualified surgeons. This electrosurgical unit is to be used
intermittently for surgical operations in the operating theatre.
It is intended for cutting and coagulation in monopolar and bipolar modes, for vessels sealing
with THERMOCLAMP® forceps; THERMOCUT® and THERMOCISION®, and for bipolar resection in
saline with Plasma Edge® electrodes.
SEAL Generator can be used in the following specialties: Gynecological and Obstetrics Surgery,
Visceral and Digestive Surgery, Cardiac and Thoracic Surgery, Orthopedic Surgery, Vascular
Surgery, Urology, ENT, Plastic and Reconstructive Surgery, Neurosurgery, Digestive Endoscopy,
Ambulatory Surgery , Pediatric surgery, Odontology, Dermatology.
The SEAL generator can be used for open surgery procedures, laparoscopic surgery, and
resection in liquid.
The use of monopolar mode is contraindicated for patients with active implants, such as
pacemakers, implantable cardiac defibrillators, or implantable neurostimulators. Monopolar RF
currents can cause disturbances and failures of these implantable devices.
The use of monopolar mode is not recommended for tissues infiltrated by a saline solution:
conductive liquids are the cause of a dispersion of the RF current which causes a decrease in the
efficiency of the current on the point of application of the active electrode. This may cause burns
far away from the point of contact with the tissues.
A short initial training in the use of the equipment is recommended, especially for the use of
Vessel Sealing modes and bipolar resection mode. It is dispensed on request by the
representatives or distributors of the company LAMIDEY NOURY MEDICAL, directly on hospital
site.

1.2. LIST OF STANDARD ACCESSORIES - COMPATIBILITIES.

The following accessories are proven and compatibility tested with SEAL generators.
Rated
Item code Description
voltage
V11SM2FN Watertight double foot pedal for mono and bipolar modes
5 Vdc
V11SM1DN Watertight foot pedal for bipolar coagulation activation
V11K250 Connection cable, disposable, 5m length, for patient neutral adhesive plate 2.1 KVp
VPLAD2, VPLEN2 Adhesive patient split-plate, disposable for adult and child N/A
11FM40 Monopolar cable, 4m length (for DERLEC pencil and monopolar forceps)
11MD25 DERLEC, electrosurgical pencil without cable, foot pedal operation 6.25 KVp
V11MCT9N TACTILEC pencil with 2 handswitches, reusable, with cable 4m.
VPMxxxxx Monopolar forceps (see catalog) 4.12 KVp
11F242 Bipolar cable, sterilizable, 4m length (for bipolar forceps) 2 KVp
VPBxxxxx Bipolar forceps all sizes (see catalog) 1,12 KVp
V11F343 Bipolar cable, sterilizable, 4m length (for THERMOCLAMP forceps) 2 KVp
V11CLPBSx THERMOCLAMP / THERMOCISION vessel sealing forceps, for open surgery. 350 Vp
V12PBS25S Cable for THERMOCUT forceps (10 mm diameter)
2 KVp
V12PBS26S Cable for THERMOCUT forceps (5 mm diameter)
V12PBN523, V12PBN524 THERMOCUT forceps, 5mm diameter (open, laparoscopic surgery) 106 Vp
V12PBN21P, V12PBN22P THERMOCUT forceps, 10mm diameter (open, laparoscopic surgery) 223 Vp

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SEAL electrosugical unit Instructions for use
NOTE: letter “x” in item code is corresponding to variable numbers, depending from items sizes and shapes.
Consult LAMIDEY NOURY catalog for all available models

The use of ACCESSORIES, and cables other than those specified or provided by the
MANUFACTURER of this equipment may cause an increase in electromagnetic emissions or
a decrease in the immunity of this device and cause improper operation.
The safety of patients and users depends not only of the generator, but also of use accessories.
It is imperative to use only accessories or consumables whose compatibility with the generator is
demonstrated.
If in doubt, it is recommended to check before use if the rated voltage of the accessory is
compatible with the output voltages of the functions used. If necessary, the output power settings
must be limited to not exceed the rated voltage of the accessory (see section 11.4 which includes
the voltage graphs depending on the output power setting for each function)

1.3. DEFINITIONS
HF/RF CURRENT: High frequency / Radiofrequency currents (f  200 KHz), emitted by ESUs
(Electrosurgical units), used for cutting and coagulating.
ACTIVE ELECTRODE: electrode intended to produce a thermal effect to get cutting or coagulation
when HF current is activated
ACTIVE PART: This is the non-insulated part of the active electrode that comes into contact with the
tissue to be cut or coagulated.
NEUTRAL ELECTRODE: electrode for closing the circuit of the HF current without producing a thermal
effect. This electrode is also called plate or dispersive electrode.
MONOPOLAR MODE: applying the HF current between a neutral electrode and an active electrode.
BIPOLAR MODE: applying of the HF current between two active electrodes.
RATED ACCESSORY VOLTAGE: The maximum output voltage that can be applied to a monopolar
electrosurgical accessory with respect to a neutral electrode connected to the patient.
For a bipolar electrosurgical accessory, the maximum output voltage can be applied in pairs of
opposite polarity

1.4. GENERAL DESCRIPTION.

SEAL unit is an electrosurgical generator of HF currents intended to produce the following
effects:
- In monopolar mode, effects of cutting, haemostatic cutting and coagulation.
- In bipolar mode, effects of cutting, haemostatic cutting, coagulation, Vessel sealing and
BIPOLAR RESECTION in saline solution.
Use in monopolar mode requires the application of a NEUTRAL ELECTRODE (plate), which may
be in one conductive surface or divided into two conductive surfaces (see the precautions for use
in § 3.1).
THE PARTS APPLIED to the patient are as follows:
- Monopolar patient circuit: 1 neutral electrode output (plate) including 2 poles, and 1 monopolar
active output.
- Bipolar patient circuit: 1 output dedicated to cutting and coagulation with 2 poles, and 1 output
dedicated to vessel sealing with 2 poles.
Use in monopolar mode requires the application of a NEUTRAL ELECTRODE (plate), which may
be in one conductive surface or divided into two conductive surfaces (see the precautions for use
in § 3.1).

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SEAL electrosugical unit Instructions for use
The generator includes an output power monitoring circuit that provides safety against the risk
of output power failure: when an output power deviation is detected, an audible and visual alert
simultaneously interrupts the emission of HF current, regardless of the mode used.
The last power settings used are automatically memorized and recalled when the power is
turned on.
The audible activation indicator is adjustable.
Activation of HF currents is achieved using a handswitched electrosurgical pencil, or a dual
control pedal for cutting and coagulation in the monopolar and bipolar modes, or a single pedal for
bipolar coagulation and Vessel sealing.
SEAL unit can be combined with an Argon flow control module to ionize the gas stream with
the fulguration current, thus producing ARGON PLASMA Coagulation (APC).

1.5. MONOPOLAR CUT

Application of a high HF current density, on a fine active electrode, produces bursting of cells
under thermal effect. Cutting effect is achieved by moving the electrode over tissues and thus
destroying cells one after the other.

1.6. MONOPOLAR COAGULATION

Monopolar coagulation causes haemostasis of capillary vessels by contact with a wide
electrode (knife, ball, thick needle), or haemostasis of a non-contact surface by means of an
electric arc.

1.7. BIPOLAR COAGULATION

Bipolar coagulation uses a bipolar forceps, or a bipolar resection loop to heat cells to the
coagulation point at about 80 ° C, or it dehydrates the cells without bursting them. The depth of
coagulation depends on the application time of the HF current. Advice:
- Do not immerse the jaws of the bipolar forceps in the blood. The blood must be evacuated
before coagulating.
- To perform tissue coagulation, the 2 electrodes must not touch each other (failure by short-
circuit).

1.8. BIPOLAR CUT

In bipolar mode, the generator presents 3 possibilities of cuts:
- The bipolar scissors cut: it is a mechanical cut that uses the HF current to coagulate the
tissues simultaneously.
- The incision with fine bipolar electrodes: a bipolar cutting current is applied between 2
pointed electrodes, which enables tissue incision to be obtained.
- Bipolar resection in saline is intended for Hysteroresection (Gynecology). A bipolar cutting
current is applied between the 2 poles of a bipolar resection electrode immersed in saline
solution (0.9% NaCl). Around the active pole is created an ionized vapor bubble (Plasma) that
allows to vaporize the tissues in contact. When the active electrode takes the form of a loop or
a blade, the displacement of the electrode is accompanied by an incision.

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SEAL electrosugical unit Instructions for use
1.9. VESSEL SEALING
Vessel sealing is intended to weld the walls of an artery or vein by melting collagen and
elastin, thanks to the thermal energy produced in tissues by the HF current in bipolar mode.
Vessel sealing requires the use of dedicated forceps, THERMOCLAMP ™, THERMOCISION ™ or
THERMOCUT ™. The output power must be adjusted according to the dimensions of the active
jaws of the forceps, and according to the type of tissue.
The surgeon is assisted by a monitoring circuit of vessel sealing cycle, which emits a sound
signal as soon as the fusion cycle is complete. If the end of the cycle is not detected in time,
then repetitive beeps warn against the risk of an unfinished merge.
Section 5.1.6 details the use and precautions for use in vessel sealing mode.

2. RECEPTION OF THE APPARATUS

2.1. RECEPTION DELIVERY CONTROL

On receiving your equipment, inspect carefully for any eventual damage during transport. All
claims will be accepted if they have been notified to the delivery driver or directly to the shipper.
If the equipment is returned, it is important to return it in the original packaging. This is a valid
guaranteed proof.
Remove the apparatus from its packaging and read carefully the enclosed instructions and
information. Ensure that the local supply voltage does not exceed more than ±10% of the mains
voltage (from 220 to 240 V, or 110 to 120 V).
WARNING: the timed fuses for 220-240 V and 110-120 V are not calibrated for the same
strength.
2.2. INSTALLATION OF THE GENERATOR
The generator’s operating voltage 220-240 V, 50Hz (110-120 V, 60Hz option) is supplied
with a power cable with a three pin end plug 10 / 16A grounded. With a metallic connector hood,
this must be grounded, for the security of the patient, surgeon and theatre staff. This must be
regularly checked.
IT IS FORBIDDEN TO OPERATE THIS APPARATUS WHICH IS NOT EARTHED.
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 equipotent 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 forceps bipolar, 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

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SEAL electrosugical unit Instructions for use
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 visible 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 scale HF ENERGY during the operation cut and coagulation
should be unlit.
° After, adjust the cut and coagulation power to the maximum, then the haemostasis level
No3. During the activation of each function, the scale HF ENERGY should be totally 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 only function with the SURGILEC SEAL.
• Readjust the power levels compatible with the operation to be carried out.

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SEAL electrosugical unit Instructions for use

3. PRECAUTIONS AND GENERAL HINTS

3.1. INSTRUCTIONS FOR USING THE HIGH FREQUENCY ELECTRO SURGERY APPARATUS (MEETS
REQUIREMENTS STANDARDS NF EN 60601-2-2)

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.
c4 - If using simultaneously the HIGH FREQUENCY ELECTROSURGERY APPARATUS and
other ELECTRONIC THERAPY MONITORING DEVICES on the same patient, the sensors of the
latter should be fitted with HF filters (inductance blocking for example) placed as near as possible
to the sensors. The monitoring electrode needles are forbidden.

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

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SEAL electrosugical unit Instructions for use
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 SEAL 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.
3.2. ADDITIONAL INFORMATION
The following warnings must be observed:
• Do not loop the electrosurgical cables while in use.
• The electrodes and instruments must not be place in contact with flammable material.
• The patient must not wear any metal objects, because of metal contact burns.
• 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.

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SEAL electrosugical unit Instructions for use
• 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:

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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.

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
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.

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SEAL electrosugical unit Instructions for use
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. The 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.

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SEAL electrosugical unit Instructions for use
4. CONNECTIONS AND CONTROLS

4.1. SYMBOLS AND PICTOGRAM

The apparatus has different symbols at the front and the back which have precise
well recognised meanings, concerning the circuit specifications. Their meanings are
explained in the chart below:
Symbols related with transport and storage conditions

FRAGILE, handle with care To carry and store away from the rain

Indication of the high position for storage Storage conditions - Temperature limits
and transport conditions (-20 ° C to +70 ° C)

Storage conditions - Atmospheric pressure

Storage conditions - Humidity limits (0-95%)
limits (500-1060 hPa)

Symbols use on the device (rear and front panel)

REFER TO INSTRUCTION
WARNING: This symbol is
MANUAL : If instructions are
intended to call attention to safety
ignored, it may cause a risk for
instructions and warning notes.
patient or operator

Equipotential connection terminal Protective earthing connection

(on the rear panel) (on the power cord)

ON / OFF switch: ON / OFF switch:

Power on (LED on) Power OFF (LED off)

Power supply voltage single phase

Apparatus emitting non ionizing

Connection socket for pedal control
radioelectric radiation

Device reference code Serial number of the device

Manufacturer name and adress Manufacturing year (YYYY)

Device including CF type applied Isolated patient circuit in HF

parts, protected against (neutral electrode without earth
defibrillation shock. connection)

Patient double plate conducting Patient plate simple conducting

surface surface

Outlet for hand-switched Outlet for electrosurgical pencil

electrosurgical pencil controlled by footswitch

Outlet for bipolar forceps Sound volume adjustment

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SEAL electrosugical unit Instructions for use
Presence of high HF voltage (risk of
burns).
Outlet for Vessel Sealing forceps. Do not touch the plugs or the
connected
conductors.
Identification of notified
The device must be disposed of in body LNE/Gmed (emitter of
a state approved recycling system. the certificate of conformity
for MDD 93/42/EC)

Desicate (forced monopolar

Soft monopolar coagulation
coagulation)

Pure cut (monopolar and

Fulgurate (monopolar coagulation)
bipolar)

Blend cut 1 (monopolar and Blend cut 2 (monopolar and

bipolar) bipolar)

Selection touch of coagulation Selection touch of cutting

modes mode

4.2. BACK PANEL

1 Switch on/off
2 Mains power input socket
3 Fuses
4 Equipotential socket
5 Description plate
6 Single footpedal socket
7 Double footpedal socket

NOTE: The serial number of the

generator is shown on the
description plate
SEAL UNIT, BACK PANEL

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SEAL electrosugical unit Instructions for use
4.3. FRONT PANEL

5. INSTRUCTIONS

1 Power setting +/- 8 Bipolar outlet

2 Selection of coagulation modes 9 VESSEL SEALING outlet
3 Selection of cuts modes 10 Monopolar outlet (3 connections)
11 Monopolar outlet controlled by footswitch
4 Selection of Forced cut
(1 connection)
5 Vessel Sealing selection 12 Patient plate connection socket
6 Audio setting +/- 13 Double / single plate selection

7 Monopolar / bipolar selection 14 Output voltage scale (Bar-graph)

5.1. STARTING, ALARM PATIENT PLATE

The electrosurgical units are conceived to function with a neutral

electrode, the single patient plate (as shown) or the double patient
or
plate, split into two sections. Whichever plate is chosen the touch N°13
can be found on the front panel.

Connect the patient plate to the connection socket N°12, 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:

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SEAL electrosugical unit Instructions for use

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 plate and skin 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.

5.2. MONOPOLAR CUT MODE

To obtain the monopolar cut operate the double foot pedal (see §6.2) or the hand control
tactile (see §6.4) the power connections are the red power socket N°10 or the three pin socket
N°9 found on the front panel.
When activated, the audible alarm and visual yellow light, (on the right (left) of the HF power
indicator) will signal that the cut operation functions.
The SELF REGULATING CUT is achieved when the FORCED CUT light (N°4) is off, if the light is
on, touch the button « FORCED » This cut is appropriate for vascularised tissue showing little
electrical resistance. With the self regulating cut, the electrical power is variable depending on
the impedance of the tissue within the power setting chosen. The sides of the incision are
therefore coagulated without charring or tissue sticking to the active electrode.
The FORCED CUT is achieved when the touch button FORCED CUT N°4 light is on. This
cut is suitable in cutting strong resisting tissue like adiposis. The priming for this cut is
made easier by a higher tension than with the self regulating cut.
An array of different cutting powers is available, press the touch selection button N°3: pure
cut, haemostatic cut and Endo-section. These different powers are also available with the self-
regulation and forced cut.
The PURE CUT allows obtaining a cutting effect with minimum haemostasis. If the
used electrode has a sufficiently fine point, this will sever with a low power and the sides
of the incision will be very slightly coagulated. The principle advantage with this
type of cutting power is that there is very little surrounding tissue destruction.
The BLEND CUT releases a modulated power that increases very clearly the
haemostasis effect on the sides of the incision. The higher level of modulation promotes
the priming of the cut. The haemostasis of the incision depends, not only on the power
modulation but also by the size of the active electrode and the speed rate of the cutting
: a knife electrode gives a better haemostasis effect than with a point electrode, the slower the
cutting action, the deeper the haemostasis. The haemostatic cut allows producing a better result
from the self-regulation cut for the incision of vascularised tissue.
The ENDO-SECTION cut is a special haemostatic cut, with a high level of haemostasis.
UNDER FLUID CUTTING GLYCIN (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

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SEAL electrosugical unit Instructions for use
imperative to choose the ENDO-SECTION self regulating cut (TURP) or the FORCED CUT with little
or no haemostasis (TUR). Check with the power indication table (appendix).

5.3. MONOPOLAR COAGULATION MODE

The activation of the monopolar coagulation is achieved by the foot pedal double (§ 6.2) or by
the hand control tactile (§ 6.4).The monopolar coagulation power is released either by the red
socket N°10, or by the three pin socket N°9 found on the front panel.
When activated, the audible alarm and the blue light, shows that the coagulation control
functions.
The monopolar coagulation is available in 4 modes: soft coagulation, coagulation by
desiccation or fulguration. The passage from one coagulation level to another is made
by the touch button (N°2). The green light shows the level selected.
The SOFT COAGULATION is slow coagulation, without charring or tissue sticking to
the active electrode. The temperature of the active electrode 80°C denature the proteins
passing from colloid to a solid state. This allows controlling the diffusion of the
coagulation within the applying time of the HF power. The diffusion in depth is about the same as
the zone coagulated on the surface.
The DESSICCATION is a rapid coagulation by cell dehydration at a temperature of
more than 100°C. This allows quick coagulation in depth, by the use of high peak current
levels this allows the power to pass through the coagulated area when in
contact with the active electrode. Coagulation by desiccation is adapted to adipose tissue.
The FULGURATION is coagulation by an arc electric without contact of the active
electrode. This allows coagulation of large areas, by moving the electrode over the surface
or allows reaching bleeding areas inaccessible by electrode contact.

The insulation of certain surgical instruments is not compatible with the high voltage in
fulguration. Consult the instruments and generators notice to check the insulation and
output power (see § 1.2.2).

5.4. BIPOLAR CUT MODE

The activation of the bipolar coagulation is achieved by the double foot pedal (§ 6.2). The
electrical power bipolar coagulation is released by the socket N°8 found on the front panel. In
case of selection of Vessel Sealingmode, the bipolar cut will be stopped.
When activating, a audible signal and the yellow signal placed at the right of the power digital
display alert that the cutting control functions.
The bipolar cut is particularly indicated for electrosurgery on patients equipped with a
pacemaker to avoid any degradation of this aparatur by the monopolar HF current passage.
The bipolar cutting currents are using with specific instruments of bipolar cut under low
tension to avoid an electrical failure of the insulation which separates the 2 active electrodes.
The bipolar cut mode can be modulated to improve the tissues haemostasis. The selection key
no 3 allows to go from an haemostasis level to another.
The bipolar resection in saline environment need high power and also to put the resection loop
into contact with the tissues before activating the current. It is useless and dangerous to activate
the cut before putting the resection loop into contact with the tissues to be resected as it will cause
the liquid overheating without cut effect. As soon as the loop reaches the required temperature to
begin the cut, it get into the tissues.

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SEAL electrosugical unit Instructions for use
CAUTION:There is only one cut setting for both monopolar and bipolar modes. After
using the bipolar cut for going to a monopolar mode, systematically verify before the
setting of the cut.

5.5. BIPOLAR COAGULATION MODE

The activation of the bipolar coagulation is achieved by the double foot pedal (§ 6.2) by the
single foot pedal (§ 6.3). The electrical power bipolar coagulation is released by the socket N°8
found on the front panel.
When activated, the audible alarm and the blue light, shows that the coagulation control
functions.
Bipolar coagulation is adapted to tissues irrigation with a saline solution: it is especially
recommended for coagulations on fat tissues, presenting high impedances. Irrigation will
significantly increase efficiency of coagulation on these tissues.

5.6. VESSEL SEALING

The touch selection button SEAL n° 5 allow to select the Vessel Sealing mode (green
key lighted). The Vessel Sealing consists in welding vessels with bipolar forceps able to
clamp vessels and an activation of several secondes (according to the width of the bipolar
jaws and the the thickness of the vessels). As a precaution, it is
imperative to provide against the risk of an eventually bleeding if the vessel sealing is not completely
achieved when cutting. A complementary coagulation, a ligation or clips laying is then necessary.
Specific advices for VESSEL SEALING
• Only use the VESSEL SEALING forceps provided by Lamidey-Noury.
• Clamp the vessel to be sealed with a forceps.
• The setting of the minimal adviced power should be higher or equal than 50 W. If the
VESSEL SEALING is too slow, do not hesitate to set up the power.
• Eventually remove blood by aspiring it or with compress in the treating area : if the
forceps jaws are submerged, the VESSEL SEALING current will spread in the liquid
which will compromise the phenomenon efficiency.
• Activate the Vessel Sealing as long as the tissues are dehydrating themselves. It is only
when there is no more steam from the tissues that the VESSEL SEALING is obtained.
An audible signal indicates that the VESSEL SEALING is done. If not, the generator will
emit a repeated beep (see paragraph on THERMOCONTROL program)
• You are advised to do a second VESSEL SEALING in proximal side (upstream from the
blood flow way). The cut will have to be done between the two sealing areas.
• Do not use the VESSEL SEALING close by a 2 vessels junction : keep a length of
approximately 1 centimeter to eventually make a ligation or lay a clip in case of failure.
• Release slowly the forceps in maintaining it in position. If a bleeding occurs, then close
immediately the forceps and generate a new VESSEL SEALING or lay two clips on the
vessel (or make a ligation).
• To be sure that the VESSEL SEALING succeeded, examine the sections. Grab with the
bipolar forceps each stump and make a complementary coagulation of them.
• In case of difficulty to obtain VESSEL SEALING, for instance on adipic tissues, soak the
tissues between jaws in physiological saline (without jaws submersion). It will improve
the conduction of these resistant tissues ant the heat obtained will allow to quickly go
to the required effect.

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SEAL electrosugical unit Instructions for use
CAUTION : during VESSEL SEALING, bipolar forceps’jaws overheat themselves. If
they get in contact with close tissues, there is a risk of thermal damage of these
tissues. If the jaws are submerged into blood or physiological saline, the VESSEL
SEALING will not be possible because of too high scattering of the current into the
liquid.

THERMOCONTROL PROGRAMM: This program consists in assisting the surgeon during the
Vessel Sealing process by emitting 3 different audible signals:
1) If the generator emits a single beep, it means that the THERMOCONTROL programm has
detected a progressive weld of the tissues and then the end of the VESSEL SEALING
process. The surgeon can then stop activating the HF current.
2) If the generator emits several repeated beeps right from the start of activation, it
means that the HF current is not passing through the tissues either because activation
occurred before the forceps were closed or due to breakage of the Bipolar cable or due
to a connection fault of the cable.
3) If the generator emits several repeated beeps after 20 seconds of activation, it means
that the conditions are not met for performing VESSEL SEALING : the power setting is
too low and/or too much tissue has been grasped. A smaller amount of tissue must then
be grasped and possibly a higher power level must be selected.

6. SETTINGS AND POWER ACTIVATION

6.1. H.F. POWER SETTINGS

The H.F. power output is adjustable by the touch button N°1 to
increase or lower the power, as shown for each function. The indication
table (see appendix) at the end of the instruction manual suggests which
selected function and setting is required, regarding the surgical
application.
The values are shown as an indication. It is advised to always look for the minimum power
level.
In the case of power failure which lasts less than 20 minutes, the generator keeps the power
settings and operational selection memorized. If the power failure lasts more than 20 minutes, it
is advisable to verify the parameters before continuing the operation.
During the verification of the different activation controls (§ 6.2 - 6.6), as a precaution, reduce
all the HF powers to 0.
6.2. DOUBLE FOOT PEDAL ACTIVATION
The double foot pedal connection is found on the back panel, as indicated (socket N°7).used
for monopolar and bipolar mode. This function commands the cutting mode with the yellow lever
and the coagulation mode with the blue lever.
To change from monopolar mode to bipolar mode or vice versa, press the touch button N°7 on
the front panel.
With the monopolar mode, the With the bipolar mode, the
power is released by the red power is released by the socket
socket N°11 into which the N°8 into which the bi-wire cable
monowire cable ref. 11FM40 is ref. 11F242 is fitted with a 2 pin
connected plug, type BCP.

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SEAL electrosugical unit Instructions for use

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)

6.3. SINGLE FOOT PEDAL ACTIVATION

The single foot pedal is connected on to the back panel (plug No 6). Intended only for bipolar
coagulation, whichever mode is selected monopolar or bipolar being used. It is not required to
select the bipolar mode button on the front panel.

6.4. HAND HELD TACTILE PENCIL ACTIVATION

Hand held electrodes are connected on to the front panel by the
connection three pin socket No 9.
For the monopolar mode (touch button No7) the blue switch button on the pencil for
coagulation monopolar and the yellow switch button for cut monopolar.
For the bipolar mode, the blue switch button will activate only coagulation (monopolar) but the
cut switch button will be ineffective.
6.5. AUDIBLE INDICATOR SETTING
The audible sound level is adjustable by the touch button +/ - shown on the front panel
by the pictogram symbolizing a loud speaker. The sound cannot be deactivated: the
minimum sound level continually indicates the activation power levels for cut and
coagulation with monopolar and bipolar mode.
6.6. DOES AND DON’TS
In Bipolar Mode, the active output connection monopolar designated for the 2nd user is
suppressed, but the 1st user has the availability of manual Coagulation. The Bipolar mode which
does not use the electrode patient plates, require no special conditions, provided that the
monopolar mode has not been requested.
In Monopolar Mode, if one of the required functions, cut or coagulation is selected, the other
one is restricted. – The generator can only function if the alarm plate is not activated.
6.7. INERT GAS ACTIVATION
By demand, the generator can be fitted with the inert gas system which is delivered with the
production of the HF current in monopolar mode:
To operate with inert blown gas, use the pedal control electrode DERLEC 25 Nitrogen with
cable, connect to the socket No 10. Connect the plug on the back panel to a source of inert gas
(nitrogen, carbon dioxide etc...), with a maximum pressure of 50 KPa (#0,5 bar).A gas cylinder
fitted with a pressure reducer adjustable from 0, or a distributor socket with a pressure reducer.
The gas flow is delivered by the activation of the generator.

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SEAL electrosugical unit Instructions for use
7. TROUBLE SHOOTING

7.1. RESPONSE FROM THE CONTROLS

7.1.1 – When the indicator [HF/ENERG] N°13 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° 13 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.

7.3.2. Excess HF Alarm

If the continual alarm and the [EXCES HF] indicator lights up: when the output power level
exceeds the limit programmed on the display panel. Turn the power off for at least 10 seconds
and then turn back on.
If the fault immediately reappears or when power is drawn, the fault must be checked by the
manufacturer or an agreed representative.

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.

8.2. ACCESSORIES AND INSTRUMENTS

8.2.1. Foot pedals
The foot pedals are cleaned like the generator, check the power cables for damage or use the
tester TESTELEC. Check the condition of the anti-slip pads under the foot pedals: wear and tear
and missing pads will make the foot pedals unstable and prevent possible activation.
The foot pedals can be decontaminated with a sterilized cleaner, as they are not autoclavable.

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SEAL electrosugical unit Instructions for use
8.2.2. Instruments in contact with the patient
The washing of the instruments, the reusable patient plates and their cables are cleaned with
soapy water or a mild detergent cleaner. Do not clean electrosurgical accessories by ultra-wave.
These instruments can be immersed in a decontamination product, except for the UNIPLAC
plates which are treated with a sterilized coating. Respect the manufacturer’s recommendations in
the length of time and temperature of the solution. Rinse thoroughly with filtered running water
and dry completely, if need be use compressed air.
The instruments and cables in contact with the patient are autoclavable at 134°C during
20minutes, except the patient plates and UNIPLAC connections.
A regular accessory check is recommended (see § 2.3.1).

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 3 rd 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.

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SEAL electrosugical unit Instructions for use
9. TECHNICAL SPECIFICATIONS

9.1. MECHANICAL AND ENVIRONMENTAL

Mobile Unit
- Fixed installation
- Installation on an arm
- Outer protection level: IP 203 - Dimension and weight:
Generator Weight Width Height Depth

SURGILEC SEAL 11 kg 420 mm 190 mm 430 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 with walls of
good thermal conductivity.

9.2. INPUT SPECIFICATIONS

Generator SURGILEC SEAL

220-240 V, 50/60 Hz
Supply :
(or 110-120 V if specified on backside)
Electric shock protection: Class 1, Type CF
Maximum power absorbed : 1200 VA
Uninterrupted operations with intermittent load
Functioning Mode:
( loaded :10 s ; stopped :30 s)
External fuses 2x TFS 5x20 6,3A 250 V
Maximum current protection :
(or 10 A for 115V supply)
Air supply (Nitrogen) optional extra : 0,5 Bar
cylinder and pressure reducer 3 to 5 dm3/mn

9.3. OUTPUT SPECIFICATIONS

Maximum power Range Monopolar : 370 W / 550 Ω

Bipolar : 100 W / 100 Ω

Maximum Self-regulating pure 1200 Vpp - 420 Vrms

peak to peak Cut
haemostasis 3 2700 Vpp - 400 Vrms
voltage
(Vpp)and Forced Cut pure 1650 Vpp - 610 Vrms
Effective
operational haemostasis 3 4200 Vpp - 600 Vrms
values (Vrms)
Coagulation Soft 3200 Vpp 320 Vrms
Desiccation 5200 Vpp 520 Vrms
MONOPOLAR: Fulguration 1 6500 Vpp 490 Vrms
MICRO CŒLIO 500 Vpp - 50 Vrms
BIPOLAR : Coagulation
FORCED 1500 Vpp - 150 Vrms

VESSEL SEALING 700 Vpp

Pure Cut 630 Vpp - 240 Vrms

Haemostatic Cut 3 1500 Vpp - 240 Vrms

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SEAL electrosugical unit Instructions for use

Mode Frequency modulation Crest factor (1)

Pure cut Monopolar and Bipolar 450 kHz 0 1.4

Haemostasis Cut 3 Mono and Bipolar 450 kHz 21 kHz 3.4

Monopolar Coagulation 450 kHz 21 kHz 4.8

Fulguration 450 kHz 21 kHz 7.5

Bipolar Coagulation 450 kHz 21 kHz 4.8

VESSEL SEALING 450 kHz 21 kHz 3.4

(1)
Crest factor: ratio between peak voltage and rms voltage (output unloaded)
10. ANNEXES

- Guidelines to Power Settings.

WARNING:
1) The following settings are an indication for adult patients. The decision lies
with the surgeon who will decide on the settings for the required results. For
first-time operations, it is advised to commence on a lower power setting
and only increase on the surgeons demand.
2) When the surgeon uses the coagulation for cutting the tissue, choose the
setting corresponding to the cut:
- Self-regulating cut setting for soft coagulation.
- Forced cut setting for desiccation.
3) For Adipose tissue, it is preferable to use desiccation and the forced cut.
4) For the initial incision which involves passing through adiposity tissue, use the adipose
tissue setting before proceeding with the required operational setting.
FOR ANY FURTHER INFORMATION, PLEASE CONTACT LAMIDEY NOURY MEDICAL.
Telephone: +33(01)69203021 – Fax: +33(01)60139747
The details in this information guide are subject to change without notice.

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SEAL electrosugical unit Instructions for use
GUIDELINES TO POWER SETTINGS FOR SURGILEC SEAL

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SEAL electrosugical unit Instructions for use

- GUIDELINES TO POWER SETTINGS THE VESSEL SEALING

Surgery Settings

Thyroïdectomy 50 – 70 W

Prostatectomy 110 – 130 W

Néphrectomy 140 – 150 W

Hysterectomy 110 – 130 W

Ovariectomy 100 – 110 W

Colectomy 120 – 150 W

Gastrectomy 140 – 150 W

Hepatectomy 90 – 100 W

- Diagram for connecting the electrosurgical instruments

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SEAL electrosugical unit Instructions for use

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