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GIMA SpA

 

DIATERMO MB250 – DIATERMO MB400 

 

MA303IGBa-19-03-2007 Manuale 

d’Istruzioni / Instruction’s Manual

 

36 

 

5.

 

SAFETY  

WARNING:

 Electro-surgery can be dangerous. Careless use of any element in the electrosurgical system may subject the 

patient to a serious burn. Read and understand all warnings, precautions, and directions for use before attempt to use any active 
electrode. Neither LED S.p.A., can be considered responsible for personal, material or consequential injury, loss or damage 
that results from improper use of the equipment and accessories. 
The accessories supplied with the unit have characteristics compatible with this supplied unit, they could be incompatible with 
others electrosurgical units; the user must check, before connecting other accessories to this unit, that they have characteristics 
of insulation compatible with those of this unit (see Technical Charactrestics).  
It is recommended to inspect the integrity of the packaging of the sterile products. 

5.1 GENERAL 

The following precautions reduce the risk of accidental burnings. 

 

The whole surface of the patient plate must be placed on a well-vascularized muscle as next as possible to surgical area. 
Avoid connecting the patient plate to bony protrusions, prosthesis, cicatricial tissues, and parts of the body subjected to 
liquid accumulation or that present subcutaneous adipose tissue. The part of the body must be without hair, dry and clean. 
Do not use alcohol to clean the skin. The use of gelatinoid substances for the electrodes is not advised. 

 

By using the neutral electrodes throwaway respect the date of expire. 

 

By using the reusable electrodes ascertain that the fixing systems give warranty of stability. 

When you apply the neutral electrode

 

avoid the transversal course and prefer the vertical or diagonal course, in particular if a 

split neutral electrode is used. That to allow an uniform delivery of the current on the surface of the neutral electrode and 
reduce the risk of burn to the patient. 

 

If it isn’t possible to use correctly the neutral electrode, consider, if it’s possible, the bipolar technic instead of the monopolar one. 

 

 

The patient mustn’t be in contact with metal parts that are connected to the earth or have a large electrical coupling 
capacity to the earth (for example: operating-table or metallic support). The use of antistatic sheets is advised.  

 

Avoid the skin to skin contact (for example between arm and body of the patient). Insert an interface material like dry 
surgical gauze. Moreover, the parts of the body subjected to abundant perspiration must be maintained dry.

 

 

   

 

(1) Treatment area 

(1) Active electrode - (2) Reference electrode 

(3) Dry gauze - (4) Antistatic cloth 

 

When high frequency electrosurgical unit and physiological monitoring devices are used at a time in the same patient, all 
the monitoring electrodes, that has not resistive or inductive elements tested high frequency interference environment, 
must be as far as possible from the electrodes of the electrosurgical unit. Avoid the use of monitoring needles. 

 

The connection to the electrodes should be located in such a way to avoid the contact both with the patient and with other 
cable, the cables mustn’t be trampled down by persons or trolleys present in operating room, they mustn’t be fixed to the 
operating field by instruments. 

 

For surgical procedures where the h.f. current could flow through parts of the body having a relatively small cross-
sectional area; the use of bipolar technics may be desirable in order to avoid unwanted coagulation. 

 

The power level should be the lowest useful to the work to do. 

 

Always check the return plate whenever electrosurgical unit fails to produce the desired effect. Reason for a low output 
power level, or for an incorrect functioning of the electrosurgical unit when arranged for a normal output, may be lack of 
connection of the return plate or its imperfect placement. 

  The use of flammable anaesthetics, of oxygen and of nitrogen protoxide should be avoid in the case of operation at the 

head or at chest level except the possibility of evacuating gas. Flammable materials used to clean, or to disinfect, should 
be let to evaporate before the use of the electrosurgical unit. There is risk of stagnation of flammable solutions under the 
patient or in body cavities as the umbilicus and the vagina. The fluid that deposits in these areas should be removed before 
the equipment use. The danger of endogenous gas ignition has to be considered. Some materials like cotton wool or 
gauze, when saturated with oxygen, may burst into flames because of the sparks produced by the equipment in the normal 
use. 

  There is a risk for the patients fitted with heart pacemaker or other stimulation electrode: interference may occur with the 

stimulator signal or the stimulator itself can be damaged. Please refer to Cardiology Unit when in doubt. 

 

Electrosurgical equipment does emit unnoticed radiation of high frequency energy that may effect other medical 
equipment, unrelated electronics, telecommunications, and navigational systems. 

 

The accessory must be regularly checked, particularly the cables for the electrodes and the possible accessories for the 
endoscopy to verify that the insulation is not damaged. 

Summary of Contents for DIATERMO MB 250

Page 1: ...Manual DIATERMO MB 250 MB 400 DIATERMO MB 250 MB 400 PROFESSIONAL MEDICAL PRODUCTS Via Monza 102 20060 Gessate MI ITALY Tel 39 02 953854209 221 225 Fax 39 02 95380056 e mail gima gimaitaly com export...

Page 2: ...Manual DIATERMO MB 250 MB 400 DIATERMO MB 250 MB 400 PROFESSIONAL MEDICAL PRODUCTS Via Monza 102 20060 Gessate MI ITALY Tel 39 02 953854209 221 225 Fax 39 02 95380056 e mail gima gimaitaly com export...

Page 3: ...sto documento pu essere fotocopiata riprodotta o tradotta in un altra lingua senza il consenso scritto della LED SpA In caso di necessit di Assistenza Tecnica contattare il proprio rivenditore These o...

Page 4: ...rrente per Coagulazione Superficiale SPEEDY COAG 20 7 4 5 Corrente per Coagulazione Profonda DEEP COAG 20 7 4 6 Corrente per Coagulazione Spray SPRAY COAG 20 7 4 7 Corrente per Coagulazione Spray con...

Page 5: ...agulation SPEEDY COAG 44 7 4 5 Current for Deep Coagulation DEEP COAG 44 7 4 6 Current for Spray Coagulation SPRAY COAG 44 6 4 7 Current for Spray Argon Coagulation SPRAY ARGON 44 7 4 8 Handle and Foo...

Page 6: ...2 COMPOSIZIONE STANDARD ED OPZIONALE codice descrizione DIATERMO MB250 DIATERMO MB400 Unit elettrochirurgica codice GMA 10400 70A GMA 10400 90A 00100 01 Cavo alim 5MT 3x1 5mm SIEM IEC 1 1 00301 04 Pe...

Page 7: ...one in modalit monopolare e taglio e coagulazione in modalit bipolare Nella modalit di coagulazione bipolare attivabile il sistema automatico di attivazione disattivazione al raggiungimento dell avven...

Page 8: ...la forma d onda della corrente ad alta frequenza prodotta dal generatore Forma dell elettrodo A punta o arrotondato a seconda delle esigenze di dimensioni assai ridotte pertanto la densit di corrente...

Page 9: ...corre dosare opportunamente la potenza erogata I2 t e attenersi alle regole per l applicazione dell elettrodo neutro sul paziente vedi capitolo SICUREZZA 2 Effetto Faradico La corrente elettrica pulsa...

Page 10: ...ttenersi nessuna resistenza al movimento dell elettrodo attraverso il tessuto nessuna variazione nel colore delle superfici tagliate nessuna fibra di tessuto residua sull elettrodo Resezione transuret...

Page 11: ...che causerebbe shock elettrico ustioni all operatore etc 3 3 TAGLIO E COAGULAZIONE BIPOLARE A differenza della tecnica monopolare con la tecnica bipolare la porzione di tessuto interessata al passagg...

Page 12: ...azioni allergiche ai disinfettanti ignizione di gas o liquidi infiammabili Alcune delle cause primarie delle ustioni sono da attribuire a un insufficiente addestramento del personale medico sanitario...

Page 13: ...izzo di un telo antistatico Dovrebbe essere evitato il contatto pelle pelle per esempio braccio tronco gamba gamba mammelle ecc inserendo una garza asciutta Inoltre le zone del corpo soggette ad abbon...

Page 14: ...igliabile Qualora il loro uso fosse necessario obbligatorio usare soltanto adattatori singoli o multipli conformi alle attuali norme di sicurezza Non lasciare l apparato esposto agli agenti atmosferic...

Page 15: ...ee o su parti anatomiche in cui sono presenti impianti protesici od elettrodi di monitoraggio Applicarlo invece su tessuti ben irrorati come i muscoli e in prossimit del sito operatorio Se si utilizza...

Page 16: ...o attivo su materiale conduttivo sebbene l isolamento sia integro Durante gli interventi di elettrochirurgia ad HF la rapida variazione del campo elettrico intorno all elettrodo attivo solo parzialmen...

Page 17: ...ll unit Collegare il punto per il collegamento equipotenziale presente sulla parte posteriore sinistra dell unit alla presa equipotenziale dell impianto Connettere la pedaliera doppia su uno dei conne...

Page 18: ...BILI 230V 2xT 4A 115V 2xT 8A DUTY CYCLE intermittenti 10 sec emiss 30 sec pausa CLASSE I CF DIATERMO MB400 APPLICAZIONI MONOPOLARI APPLICAZIONI BIPOLARI FREQUENZA 425kHz FREQUENZA 525kHz Uscita CUT TA...

Page 19: ...accensione unit 21 Sezione di controllo ed indicazione livello di coagulazione bipolare 4 Tasto spegnimento unit 22 Tasto Select per coagulazione bipolare automatica 5 Sezione per controllo ed indicaz...

Page 20: ...zione OC priva di segnale acustico presente solo durante l erogazione e mostra il nuovo valore di impedenza L utente pu conoscere il valore dell impedenza sul paziente premendo una volta in fase di no...

Page 21: ...all ordine di disposizione dei tasti di selezione nelle sezioni MONOPOLAR 1 e MONOPOLARE 2 vedi Fig 1 7 4 1 TAGLIO E TAGLIO COAGULATO CUT La corrente migliore per il taglio la sinusoidale pura senza m...

Page 22: ...scintilla dell Argon e quindi ad iniziare il processo di coagulazione senza contatto tra elettrodo attivo e tessuto che risulta estremamente efficace ed utile non solo nella chirurgia tradizionale a c...

Page 23: ...60 e 40 scegliendo il duty cycle della corrente erogata mediante i tasti e il valore del duty cycle impostato indicato dall accensione della spia corrispondente Naturalmente il grado di coagulazione...

Page 24: ...ssociato alla coagulazione blu Per non danneggiare la pinza non cortocircuitarne le punte 7 6 SEGNALAZIONE DI TEMPO DI EROGAZIONE ECCESSIVO OVT Qualora l operatore ecceda il tempo massimo di erogazion...

Page 25: ...one delle correnti monopolari di coagulazione Connettore pedale per il taglio e la coagulazione monopolare2 Punto di connessione del pedale per realizzare il taglio o la coagulazione monopolare MONOPO...

Page 26: ...ura Il suddetto modulo di alimentazione incorpora il connettore di alimentazione i fusibili di linea e il selettore di tensione ATTENZIONE Prima di accendere l apparecchiatura l operatore dovrebbe acc...

Page 27: ...20W 1509 120W 1509 20 Potenza max bipolare BIPOLAR CUT COAG W 80 100W 1509 100W 1509 20 Potenza max bipolare BIPOLAR CUT COAG W 60 100W 1509 100W 1509 20 Potenza max bipolare BIPOLAR CUT COAG W 40 60W...

Page 28: ...o kg 18 18 5 Alimentazione selezionabile V 115 230 115 230 1 Frequenza di rete Hz 50 60 50 60 0 Fusibili per alimentazione 230V 5x20 Ritardati 2xT 4A 2xT 5A 0 Fusibili per alimentazione 115V 5x20 Rita...

Page 29: ...avi di alta frequenza gli adattatori e gli elettrodi 9 4 GUIDA ALLA SOLUZIONE DI PROBLEMI In caso di problemi si consiglia prima di tutto di controllare di aver eseguito correttamente l installazione...

Page 30: ...Verificare l integrit delle confezioni dei prodotti forniti sterili Effettuare scollegando il cavo dell elettrodo neutro un controllo visivo e funzionale dell allarme OC acustico luminoso Effettuare...

Page 31: ...B400 Electrosurgical Unit code GMA 10400 70A GMA 10400 90A 00100 01 Power supply cable 5MT 3x1 5mm SIEM IEC 1 1 00301 04 HP double water proof foot switch 2 2 00404 07 Cable for neutral plate F7915 F7...

Page 32: ...er current for monopolar cut coagulated cut with different levels of coagulation in monopolar modality and cut and coagulation in bipolar modality In the bipolar modality for the coagulation the autom...

Page 33: ...o the necessity it has reduced dimension for this the current density on the point surface A m 2 is highest The electrodes with a thin section create an high current density an high temperature favour...

Page 34: ...e patient see cap SAFETY 2 Faradic Effect The pulsed current causes the neuro muscular stimulation originated by stimulation of physiologic process of ionic exchange responsible of the transmission of...

Page 35: ...f the cut surfaces no tissue fibre residual on the electrode Transurethral resection A particular use of the cut is represented by the immersion of the active electrode for this scope it s used a meta...

Page 36: ...sue interested by current passage in high frequency is very small In this technic the bipolar forceps are used with different dimensions and shapes on which distal ends there are active and neutral el...

Page 37: ...only one In fact necrosis by compression allergic reactions to the disinfectant gas or inflammable liquids ignition Some important causes of burns are by insufficient medical equipe training about al...

Page 38: ...of the body subjected to abundant perspiration must be maintained dry 1 Treatment area 1 Active electrode 2 Reference electrode 3 Dry gauze 4 Antistatic cloth When high frequency electrosurgical unit...

Page 39: ...and dangerous The manufacturer can not be considered responsible for possible damages due to improper wrong and unreasonable uses It is dangerous to modify or try modifying the characteristic of the...

Page 40: ...eduction of the skin perfusion So the heat created can be partially eliminated and so the risk of burns increases The hazard of decubitus increases too because for the produced heating the O2 and ener...

Page 41: ...isks of patient injury a better and more complete training for the medical staff visual examination of the surgical instrumentation active electrode laparoscope use of disposable electrodes but the th...

Page 42: ...binding post located at the left of the unit s back panel to equipotential socket of the plant Connect the double to the connector on the frontal panel in the MONOPOLAR 1 section for monopolar cut an...

Page 43: ...V 2xT 4A 115V 2xT 8A DUTY CYCLE intermittent 10 sec emission 30 sec of pause CLASS I CF DIATERMO MB400 MONOPOLAR APPLICATION BIPOLAR APPLICATION FREQUENCY 425kHz FREQUENCY 525 kHz Output CUT CUT 400W...

Page 44: ...for bipolar currents delivery 7 3 OPERATION MODE 7 3 1 SWITCHING ON When switched on the electrosurgical unit reports on the LCD display PROGRAM section the code of used deepware and performs automati...

Page 45: ...programs by the keys down and up Press the enter key to select the desired program By pressing the esc key you can esc from this function but without any selection 3 Errors Press the enter key to ente...

Page 46: ...agulation deep coag With this a MIXING current suited for cut coagulated in absence of eschar and carbonization is obtained particularly suitable for endoscopic surgery 7 4 4 CURRENT FOR SUPERFICIAL C...

Page 47: ...the corresponding push button on the device An handle without push buttons and double foot switch connect the handle on the active connector and press the yellow foot switch to select and to supply t...

Page 48: ...ng warning light The delivery is started by pressing the foot switch if also there isn t a contact between tissue and active electrode and stops itself for the impedance value higher than 200 Ohm So b...

Page 49: ...ic signal for the delivery between min and max power regulation To modify the level of the acoustic signal for the delivery it must use the regulator speaker volume placed on the back panel setting a...

Page 50: ...urrents can be distributed to realize the bipolar cut and coagulation Double foot switch for the bipolar cut and coagulation Point of the foot switch connection Remember that by the pressure of the ye...

Page 51: ...trical net see chap INSTALLATION 7 11 3 POWER ON OFF MECHANICAL SWITCH The POWER ON OFF mechanical switch is used to control power to the equipment To power the equipment press the switch in the direc...

Page 52: ...m output bipolar power BIPOLAR CUT W 120W 1509 120W 1509 20 Max output bip power BIPOLAR CUT COAG W 80 100W 1509 100W 1509 20 Max output bip pow BIPOLAR CUT7COAG W 60 100W 1509 100W 1509 20 Max output...

Page 53: ...Vpp 1100 1100 15 Maximum output voltage BIPOLAR COAG Vpp 400 400 0 5 Size LxHxP mm 470x150x380 470x150x380 10 Weight kg 18 18 5 Selectable mains power V 115 230 115 230 1 Mains frequency Hz 50 60 50 6...

Page 54: ...he unit and for the correct connection of the accessories The code of the produced error is visualized on the seven segments display while the description is on the LCD display Problems Probable Cause...

Page 55: ...ould be used are available and sterilised Inspect the integrity of the packaging of the sterile products Check by disconnecting the reference electrode cable the functioning of the OC light and sound...

Page 56: ...25 150 0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800 850 900 950 1000 Load Ohms Power Watts 100 50 Diagrams of half and maximum output power versus impedance load 10 1000 BIPOLAR CU...

Page 57: ...0 50 60 0 10 20 30 40 50 60 Setting Power Diagrams of output power BIPOLAR CUT40 versus nominal value BIPOLAR BLEND 300 OHM 0 20 40 60 80 100 0 20 40 60 80 100 Setting Power Diagrams of output power B...

Page 58: ...0 20 40 60 80 100 Setting Vpeak Diagrams of SPEEDY COAG maximum mains voltage output versus Vp DEEP COAG Vpeak max 0 100 200 300 400 500 600 0 20 40 60 80 100 120 Setting Vpeak Diagrams of DEEP COAG m...

Page 59: ...power versus impedance load 100 2000 SPEEDY COAG DEEP COAG 0 25 50 75 100 125 150 0 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 Load Ohms Power Watts 100...

Page 60: ...60 80 100 120 140 0 20 40 60 80 100 120 Setting Power Diagrams of output power SPEEDY COAG versus nominal value DEEP COAG 200 OHM 0 20 40 60 80 100 120 140 0 20 40 60 80 100 120 Setting Power Diagram...

Page 61: ...3000 0 20 40 60 80 100 Setting Vpeak Diagrams of SPRAY COAG maximum mains voltage output versus Vp BIPOLAR CUT100 Vpeak max on 5200 Ohm 0 50 100 150 200 250 300 350 400 450 500 0 20 40 60 80 100 120 S...

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