Electrosurgical unit, Model B900 EXCELL 400 MCDSe

Electrosurgical unit, Model B900 EXCELL 400 MCDSe

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. 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.

TECHNICAL FEATURES

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

Class and EC Certificate (93/42+2007/47): IIB, CE0051-nr. 187/MDD.

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.

Monopolar and bipolar working frequency: 440kHz.

Self-Regulation System with double micro-processor Master Sleeve System:

Auto-Check, complete auto-control of the functioning, through:

• Main Auto-Check: main 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 e 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.

The initial pulse of the cut currents is optimized automatically in order to obtain the

maximum efficacy.

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, da 200W=10W.

Bipolar: 0/10W=0,5W, 10/30W=1W, 30/100=2W, da 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: 230/115V± 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 60601-2.

Cooling: by convection, without fan.

Equipotential Connection: standard plug DIN 42801.

Dimensions and Weight (LxDxH): 400/A MCDSe: 38x38x16cm. – 16kgs.

400 MCDSe, 350 MCDSe, 250 MCDSe, 200 MCDSe: 38x35x16cm. – 15kgs.

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 autocompensation

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.