DIATHERMY UNITS AND ARGON GAS ENHANCED DIATHERMY UNITS FOR MAJOR SURGERY EXCELL MCDSe SERIES

DIATHERMY UNITS AND ARGON GAS ENHANCED DIATHERMY UNITS FOR MAJOR SURGERY EXCELL  MCDSe SERIES

The equipments of the series Excell MCDSe System are electrosurgical units for major surgery, suitable for all operations where the monopolar and the bipolar techniques are used, as well as the monopolar mode with the Argon gas flow. The units are available in 5 different models. The models 400 MCDSe, 350 MCDSe, 250 MCDSe, and 200 MCDSe are indicated for electrosurgery, but they can be also connected to an external module for the Argon gas. By the contrary, the model 400/A MCDSe is suitable both for electrosurgery and electrosurgery with Argon gas. It is equipped with all the necessary functions for this type of application, and so it is easier to use.

AUTO-CHECK AND SELF-REGULATION OF OUTPUT POWERS MCDSe System

A new system with double microprocessor Master Slave System ensures a wide range of functions and performances at a very high level.
	Auto-Check: complete auto-control of the functioning, through:
•	Main Auto-Check, main auto-diagnosis procedure at the switching-on and Standard Auto-Check, continuous auto-diagnosis during the functioning;
•	General Error Control e Output Error Control: the auto-check systems interrupt the functioning and inform the operators through specific Error Codes in case of damages or errors in the functioning / switching on, or in case of problems that could provoke a sudden delivery of power, which is higher than the selected one.
	ADC System-constant power e Starting Impulse Control.
	All the currents are automatically and dynamically self-regulated, according to a continuous feed-back between the unit and the tissues on which the operator intervenes, and according to the electrode used and its rapidity of sliding on the tissues themselves. All the cutting currents are characterized by a starting pulse, which is controlled and automatically optimized to obtain the maximum efficacy. These two systems guarantee the best results in all the operating fields, by using the minimum possible power (the interventions under liquid included).

10 PROGRAMMABLE MEMORIES

The MCDSe models have the possibility to memorize 10 functioning programs that are selectable through a simple button. In this way, the different performances can be personalized and then reproduced.

HIGH FREQUENCY LEAKAGE CURRENTS CONTROL CIRCUIT

A specific circuit verifies that the HF leakage currents to hearth always remain within the safety limits, in order to avoid all risks of burns, even in dangerous situations like the contact between the patient and a small part of the operating table.

SAFETY CIRCUIT OF THE NEUTRAL PLATE - NPCC System

The safety circuit of the neutral electrode guarantees its complete control. With the twin section electrodes Split type, it fully checks the connection and the quality of the contact between the electrode and the patients’ tissues. If the contact is not optimum (approx. 80% of a standard electrode for adults), it gives the first luminous indication. If the contact decreases to approx. 50% of a standard electrode for adults, it gives another luminous indication, and automatically reduces the power at a safety level of 200 W. If the contact is dangerous or the electrode cable is broken / not connected at all, it interrupts the delivery of the power, through a luminous and acoustic alarm. With the one single section electrodes Non Split type, it only controls if the cable is integral and correctly connected.

PRACTICALNESS AND EASINESS

On the front panel, which is completely smooth and easily washable, there are all the control devices with selection buttons for the functions and adjustable buttons for the powers; there are also luminous activation signals or alarm signals, as well as the powers control displays. The outputs are characterized by luminous indications that light up according to the usage modes that have been selected, in order to favour the connection and the activation of the accessories.

GREAT RELIABILITY, TECHNICAL ASSISTANCE AND TECHNOLOGICAL EVOLUTION

The Excell MCDSe models have been designed with interchangeable boards, and they are equipped with a new generator RF Mosfet Powered Damped Oscillator with alimentation device switching that does not cause any problem of heating; the test procedures also include a “stress test” of 100 hours of functioning at max. power. The Auto-Check systems memorize the last 32 Error Codes for the future controls, while the functioning and the auto-check softwares can be easily updated, through a serial port for a connection to a PC.

WIDE RANGE OF CURRENTS AND PERFORMANCES

All the Excell models are equipped with 13 currents to satisfy all possible operating needs; these currents become 14 into the model 400/A MCDSe. Four for the monopolar cut, with sinusoidal wave, which can be used even with the Argon gas flow into the model 400/A MCDSe in order to reduce the smokes and the smells. They ensure the maximum rapidity and precision in all the operating fields, the procedure under liquid included.

• Pure: Pure cut without any coagulating effect;

• Blend 1: Coagulating cut with normal haemostatic effect. The two currents are characterized by special self-regulation softwares, which are particularly useful for the TUR interventions, the vaporisation, etc.

• Blend 2: Coagulating cut, with strong haemostatic effect, spray type;

• Endo:Coagulating cut, with cut phases alternated to coagulation phases and a special self-regulation software for its usage in flexible endoscopy.

Four for the monopolar coagulation, which allow to obtain different coagulation effects.

• Soft: Very delicate, with soft superficial effect and strong deep action;

• Fulg Forced: With strong superficial and deep effect;

• Pin Point Contact: Similar to the previous one, but softer;

• Spray:Without any contact and with a very strong superficial effect.

One for the Argon gas coagulation, into the model 400/A MCDSe

This current consists of a special coagulation without any contact, which can be obtained by combining the spray coagulation with an Argon gas flow through specific electrodes that guarantee a very rapid superficial effect, a very small deep action (3mm max.), an absolute absence of the sticking effect of the electrode on the tissues, and a minimum risk of perforation.

Two for the bipolar cut, which allow to use this technique with scissors, hooks for laparoscopy, etc.

• Pure: Pure cut with minimum coagulating effect;

• Blend: Coagulating cut with strong coagulating effect.

Three for the bipolar coagulation.

• Micro: Very delicate, Micro Precise type, with a minimum sticking effect of the tissues on the tips of the forceps;

• Micro Auto: The same as Micro, but with Impedance Sensing automatic Auto Start / Auto Stop device;

• Macro: Standard type, which is very rapid and efficacious, ideal for forceps with bigger section (i.e. laparoscopy).

TWO MONOPOLAR AND ONE BIPOLAR OUTPUTS

The two monopolar outputs, which can be used at the same time by two different operators, can be activated by three modes:

• Both of them by the hand-switch electrodes holder handles, both of them by the double pedal foot-switch or one by the hand-switchs and one by the double pedal foot-switch.

Into the model 400/A MCDSe, when also the functioning with Argon gas is selected, the outputs are activated alternatively:

• Both of them by the hand-switch electrodes holder handles or both of them by the double pedal foot-switch, one for the normal electrosurgery and one for the Argon gas enhanced electrosurgery;

The bipolar output, which can be used independently and at the same time as the monopolar ones, can be activated by two modes:

• For the cut or the coagulation, by the double pedal foot-switch;

• For the coagulation, by selecting the current Micro Auto with Impedance Sensing automatic Auto Start / Auto Stop device with Start Delay adjustable from 0 to 5sec. This represents a very useful system, which allows obtaining coagulation by the hand-switch activation without using any special forceps.

THE PEDAL FOOT-SWITCHES

The Excell units can be used by one double foot-switch pedal for the activation of the monopolar or bipolar functions and by two double foot-switch pedals, one for the monopolar functions and the other for the bipolar functions.

ELIMINATION AND FILTERING OF THE ELECTROSURGICAL SMOKES

In order to eliminate the bacterial/viral contamination, the Excell units can be used together with electrosurgical smoke evacuators, which are equipped with suction functions expressly studied for the laparoscopic procedures and for solving the problem of a perfect visual field while operating.

TECHNICAL FEATURES

Electronic Generator, compliant with: IEC 601-1 and IEC 60601-2-2 Standards

Classification 93/42 EEC: IIB

Approval 93/42 CEE: 187/MDD - IMQ 0051

Electromagnetic Compatibility: Unit is compliant with IEC 60601-1-2, Test report IMQ nr.80SF00709/1, 80SF00709/2

Classification and Type IEC 601-1: Class I, Type CF Typical LF leakage currents: on the patient: 4 µA= 0,004mA, into the enclosure: 1 µA= 0,001mA, to earth: 30 µA= 0,3mA

Output Circuit according to IEC 60601-2-2:“Floating”Insulated at low and high frequencies, protected against the use of the defibrillator. Typical high frequency leakage currents: 100 mA

ALSA Quality System: Approved ISO 9001:2000 and ISO 13485:2003.

Monopolar and bipolar working frequency: 440kHz

Self-Regulation System with double micro-processor Master Slave System con: Auto-Check, complete auto-control of the functioning, through: • Main Auto-Checkmain auto-diagnosis procedure at the switching-on; • Standard Auto-Check continuous auto-diagnosis during the functioning; • General Error Control and Output Error Control. the auto-check systems interrupt the functioning and inform the operators through specific Error Codes in case of errors in the activation, damages in the functioning or in case of problems that could provoke a delivery of power, which is higher than the selected one.

ADC System-constant power and Starting Impulse Control All the currents are automatically self-regulated, according to a continuous feed-back in real time (7,000 checks / sec) between the unit and the tissues on which the operator intervenes, and according to the electrode used and its rapidity of sliding on the tissues themselves.

Functioning memorization: 10 programs

Control of high frequency leakage currents: : by a specific circuit with alarm signal and automatic decrease of output powers.

Outputs, Activations, and Pedal Foot-switches There are two monopolar outputs that can be used at the same time by two operators: • Both of them by the hand-switches, both of them by the double foot-switch pedal or one by the hand-switches and one by the double foot-switch pedal. Into the model MCDSe 400/A, when also the functioning with Argon gas is selected: • Both of them by the hand-switches or by the double foot-switch pedal, one for the normal electrosurgery and the other for the electrosurgery with Argon gas. There is one bipolar output, which can be used independently and at the same time as the monopolar ones: • For the cut or the coagulation, by the double foot-switch pedal; • For the coagulation, by selecting the current Micro Auto with Impedance Sensing automatic Auto Start / Auto Stop device with Start Delay adjustable from 0 to 5sec. The Excell units can be equipped with: • One double foot-switch pedal for the activation of the monopolar or bipolar functions; • Two double foot-switch pedals (one for the monopolar functions and the other for the bipolar functions). The pedals are compliant with the Standard IEC 60601-2-2, they are waterproof (IPX7) with low voltage 12VDC supply for medical safety.

Micro/macro adjusting powers by push-buttons with low/fast changing and steps: Monopolar:0/30W=1W, 30/100W= 2W, 100/200W=5W, from 200W=10W Bipolar: 0/10W=0,5W, 10/30W=1W, 30/100=2W, from 100 W=5W

Powers control: by displays

Safety Circuit of the Neutral Electrode NPCC System Control of the connection/contact of the neutral electrodes Split - twin section type, as well as of the electrodes Non Split - one single section type. With the Split type, it fully checks the connection and the good contact of the electrode. If the contact is not optimum (approx. 80% of the surface of a standard electrode for adults), it gives the first luminous indication. If the contact decreases to approx. 50%, it gives another luminous indication, and automatically reduces the output power at max. 200W. If the contact is dangerous or the electrode cable is broken / not connected at all, it interrupts the delivery of the power and gives a luminous (red) and acoustic (loud, intermittent, not adjustable) alarm. With the Non Split type, it only controls if the cable is integral and correctly connected.

The acoustic and luminous signals are compliant with IEC 60601-2-2

Activation of the Cut (yellow light - loud sound); Activation of the Coagulation (blue light - acute sound);

Neutral Electrode (red light - loud, intermittent and not adjustable sound).

Mains:230/115VAC± 10% ~ 50/60Hz

Absorption at 230V: Max power 3,6A=828VA, Stand-by 0,4A= 92VA

Enclosure: protected against the penetration of liquids, according to IEC 60601-1

Cooling: by convection, without fan

Equipotential Connection: standard plug DIN 42801

Dimensions and Weight (LxDxH):  400/A MCDSe: 38x38x16 cm – 16 Kgs 400 MCDSe, 350 MCDSe, 250 MCDSe, 200 MCDSe: 38x35x16 cm– 15 Kgs

Facility to use an external module for Argon gas All the models: 400 MCDSe, 350 MCDSe, 250 MCDSe, 200 MCDSe

Argon gas section (only into the model Excell 400/A MCDSe) Supply: Both with 1 or 2 cylinders of 5lt. and with centralized system Max. Flow and Gas Pressure: 15lt/min. At the entrance: 2.5atm; during the functioning: 1atm

Control of the flow through Constant Flow System: from 1 to 15lt/min, through an electronic sensor with adjusting buttons, visual check on the bar-led, automatic auto-compensation according to the used electrode, and alarm just in case of absence of gas.

Control of the pressure into the circuit Safety Gas System: Reducer of the pressure on the cylinder; internal reducer of the pressure with safety valve; pressure sensor connected to the electronic control system with Auto-Check when the gas section is switched on.

Protection of the delivered gas flow: The gas output is equipped with antibacterial filter.

OUTPUT POWERS, NOMINAL LOADS OPEN CIRCUIT PEAK-TO-PEAK VOLTAGE, CREST FACTORS, MODULATIONS (Mod), DUTY CYCLE (Duty)

Monopolar Power	EXCELL 400 MCDSe*	EXCELL 350 MCDSe	EXCELL 250 MCDSe	EXCELL 200 MCDSe
PURE - Cut Mod:- Duty:-	400 WRMS a 350 ohm 3450 Vpp CF 1.6	350 WRMS a 350 ohm 3450 Vpp CF 1.6	280 WRMS a 350 ohm 3450 Vpp CF 1.6	200 WRMS a 350 ohm 3450 Vpp CF 1.6
BLEND 1 - Blend Cut Mod: 29kHz Duty: 65%	300 WRMS a 350 ohm 3600 Vpp CF 2.3	300 WRMS a 350 ohm 3600 Vpp CF 2.3	280 WRMS a 350 ohm 3540 Vpp CF 2.3	200 WRMS a 350 ohm 3500 Vpp CF 2.3
BLEND 2 - Blend Cut Mod: 19 kHz Duty: 9%	140 WRMS a 600 ohm 7600 Vpp CF 8.1	140 WRMS a 600 ohm 7600 Vpp CF 8.1	140 WRMS a 600 ohm 7600 Vpp CF 8.1	140 WRMS a 600 ohm 7600 Vpp CF 8.1
ENDO - Blend Cut composto da: 50% PURE- 50% PINPOINT	250 WRMS a 350 ohm 1880 Vpp CF 7.1	220 WRMS a 350 ohm 1880 Vpp CF 7.1	220 WRMS a 350 ohm 1880 Vpp CF 7.1	200 WRMS a 350 ohm 1880 Vpp CF 7.1
FULG FORCED - Fulguration Mod: 78 kHz Duty: 35%	150 WRMS a 350 ohm 4700 Vpp CF 4.5	150 WRMS a 350 ohm 4700 Vpp CF 4.5	150 WRMS a 350 ohm 4700 Vpp CF 4.5	150 WRMS a 350 ohm 4700 Vpp CF 4.5
PINPOINT CONTACT- Coag Contact Mod: 29 kHz Duty: 50%	250 WRMS a 250 ohm 3460 Vpp CF 2.6	250 WRMS a 250 ohm 3460 Vpp CF 2.6	250 WRMS a 250 ohm 3460 Vpp CF 2.6	200 WRMS a 250 ohm 3400 Vpp CF 2.6
SOFT - Coag. Soft Mod: 29 kHz Duty: 56%	280 WRMS a 250 ohm 3440 Vpp CF 2.5	280 WRMS a 250 ohm 3440 Vpp CF 2.5	280 WRMS a 250 ohm 3440 Vpp CF 2.5	200 WRMS a 250 ohm 3020 Vpp CF 2.5
SPRAY - Coag. Spray Mod: 19 kHz Duty: 9%	140 WRMS a 600 ohm 7600 Vpp CF 8.1	140 WRMS a 600 ohm 7600 Vpp CF 8.1	140 WRMS a 600 ohm 7600 Vpp CF 8.1	140 WRMS a 600 ohm 7600 Vpp CF 8.1

*Model MCDSe 400/A delivers the same power level of MCDSe400; it's already completed with Argon coagulator inside the unit.

Bipolar Power	EXCELL 400 MCDSe	EXCELL 350 MCDSe	EXCELL 250 MCDSe	EXCELL 200 MCDSe
PURE - Cut Mod: - Duty: -	140 WRMS a 300 ohm 790 Vpp CF 1.5	140 WRMS a 300 ohm 790 Vpp CF 1.5	99 WRMS a 300 ohm 790 Vpp CF 1.5	140 WRMS a 300 ohm 790 Vpp CF 1.5
BLEND - Blend Cut Mod: 29 kHz Duty: 75%	120 WRMS a 300 ohm 980 Vpp CF 1.8	120 WRMS a 300 ohm 980 Vpp CF 1.8	120 WRMS a 300 ohm 980 Vpp CF 1.8	120 WRMS a 300 ohm 980 Vpp CF 1.8
MICRO - Coag. Micro Precise Mod: - Duty: -	120 WRMS a 100 ohm 450 Vpp CF 1.7	120 WRMS a 100 ohm 450 Vpp CF 1.7	120 WRMS a 100 ohm 450 Vpp CF 1.7	120 WRMS a 100 ohm 450 Vpp CF 1.7
MICRO AUTO- Automatic Coag. Micro Precise Mod: - Duty: -	120 WRMS a 100 ohm 450 Vpp CF 1.7	120 WRMS a 100 ohm 450 Vpp CF 1.7	120 WRMS a 100 ohm 450 Vpp CF 1.7	120 WRMS a 100 ohm 450 Vpp CF 1.7
MACRO - Standard Macro Coag. Mod: - Duty: -	120 WRMS a 100 ohm 760 Vpp CF 1.7	120 WRMS a 100 ohm 760 Vpp CF 1.7	120 WRMS a 100 ohm 760 Vpp CF 1.7	120 WRMS a 100 ohm 760 Vpp CF 1.7