Alsa Alsatom SU-50, Alsatom SU-100, Alsatom SU-140 User manual

INSTRUCTION MANUAL

ALSATOM SU 50-MPC, SU 100-MPC, SU 140-MPC, SU 140/D-MPC

This unit is manufactured by ALSA APPARECCHI MEDICALI S.R.L., Via C. Bonazzi 16 , 40013Castel Maggiore (BO), Italy, that guarantees its safety, reliability and perform ances only if installation, recal ibrations and repairs are carriedout by personnel authorized by ALS A a nd if the unit is used in compliance with t he given instructi ons inan area tha t meets all the applicable IECor CE I r equirements. T he manufacturer is at dis posal t o supply, if requested, the electric diagrams and any further information.

In accordance with the ALSA procedures for the after-sale control of the production, the users are pleased to inform the Manufacturer about every, even little, problem of this unit.

INTRODUCTION

In a biological tissue crossed by an electric current are shown the following effects: - thermal, faradic, electrolytic.

By using HF electric curr ent the last 2 und isired and useless effects are eliminated and it is tilizedu above all the thermal effect. In fact when an electric current having such characteristics flows, from the active electrode to the neutral one, with sufficient density the cellular liquid of the tissues warms it and produces the following effects:

1)heating is so quick that the pressure of the vapour created in the cells breaks their membranes (cutting);

2)heating is lower, so the liquid slowly evaporates allowing the coagulation of the coagulable components of the tissues (coagulation or haemostasis);

3)the effect is a middle way between the two above-described ones (cut with coagulation).

The ESU is “ HF device” that may destroy the cells of biologicaltissues and therefore it should be used by expert staffs in electrosurgery and respecting strictly all the given instructions.

The ALSATOM SU-MPC series can be used for every kind of monopolar/bipolar cut and coagulation/microcoagulation in:

GYNAECOLOGY, DERMATOLOGY, PLASTIC SURGERY, DENTAL AND MAXILLO-FACIAL SURGERY, ANGIOLOGY, GENERAL SURGERY, ORL, GASTROENTEROLOGY, VETERINARY.

In particular, the functions are as follows:

- CUT:	Monopolar pure cut without coagulation
- BLEND:	Monopolar cut with coagulation
- COAG:	Monopolar coagulation (high voltage-fulguration)
- COAG MICRO	Monopolar coagulation (low voltage-soft)
- BIPOLAR	Bipolar coagulation.

Before using these units, control their performance (for example on a piece of meat) without relying completely on the previous experiences with other devices. Always start with very low powers, then gradually raise up until obtain the desired surgical effect.

GENERAL PRECAUTIONS – It is dangerous to ignore the following warnings:
1-	It is dangerous to use the device if the operating theatre doesnot meet CEI/IEC electrical requirements.
	- Do not use “extension leads”	for the power s upply cable. Coactntthe	technical d epartment for the com patibility of o ther
	equipment eventually in use.
2-	It is extremely dangerous to use accessories or instruments which are not perf ectly compliant with all the applicable technicalor
	legislative Rules, and which	are not suitable f or therkingwo voltag es	of th e device ( approx. 2800Vpp “1500Vp” for the
	monopolar currents with cr est factors equalor higher th an 2; 120 0 Vpp “600Vp” forthe monopolar currents with crest factors
	lower than 2; approx. 400Vpp “220Vp for the bipolar currents with crest factors equal or lower than 2). Moreover, the accessories
	and instruments must not be old nor worn. Check always their status before the use, notably if for endoscopy. Bear in mind that:

-All the old/worn active electrodes, accessories and cables do noworkt properly, and do not guarantee the perfect insulation. In addition, their unstable functioning can lead the operator to increase the output powers at dangerous levels;

-In the user manual, for each current, the maximum output voltage “Vpp” and its variation (see the curves) according to the output

	power adjustment are specified. This allows the operators tochoose the maximum output power that must not be overcome, in
	order to not exceed the rated HF insulation voltage, which is possible for each accessory;
-	The standard monopolar activ e	electrodes for n ormal surger y h avestem with Ø 2.3mm (	so, the stand ard electrode-ho lder
	handles are suitable for the electrodes having stems with this diameter).
3-	The interference of HF units may harm the other electromedical equipments in use.
4-	Contact cardiological department when using a HF unit on patient with pace-maker (the device can interfere its efficiency causing
	fibrillations and ect. or damage their electrodes).
5-	Always take metal objects off the patients (ring, chain and etc.). Do not use a HF unit in the presence of flammable anaesthetic
	gases (i.e. oxygen, nitrogen protoxide and etc.) especially if operating in cavities (chest, abdomen, trachea, head, etc.)
6-	Do not use flammable cleanin	g substances,disinfectants or s olvents, or a t l east c arefully	ev aporate th em be fore oper ation.
	Always remove the remaining substances from hollow parts of the body or cavities (umbilicus, vagina, etc.) and from underneath.
	While using the device, a spark	may causthe endogenous gas (intestin e) explosion orset fire to ox ygen satu rated material
	(cotton, gauze, etc.).
7-	Prevent the patient from touching an y metalparts connected to earth or electricityconductors (table, supports, etc.) and isolate
	strongly secreting parts of the body and skin-to-skin contacts by using dry covers (i.e. between arm and body).
8-	Position monitoring electrodes	(not specif ically s hielded) as fa r as pos sible fr om the el ectrodes of the HF u nits. If pos sible
	avoiding the needle type or small-sized ones.
9-	Use and position the neutral electrode as follows:

-Choose an area of the body as near as possible to the area to beoperated (the ideal is a flabby part without hairs where there are no protruding bones or uneven surfaces). Clean it, shave it and massage it to favour circulation.

MN SU-MPC ING March 2008

Page 1 of 9

-Firmly fix the electrode without placing anything in-between,ensuring the best contact possible over the entire surface but without pressing too hard to avoid creating ischemic areas (maybe use conductive gels, etc.) and always make sure that the contact is constant, especially if the patient is moved or when liquids are poured.

10The position of the neutral electr ode with regard to the operating area creates an HF current route and remember that any metal objects (prostheses, catherters, etc.) in that area may cause current concentrations that heat or even burn the adjacent tissue.

11Position the cables of the electrodes so that they do not touch the patient or other wires. 12Always use the lowest power possible to the surgical need.

The insufficient performance of the equipment may depend on: wrong positioning or fault y contact of the neutr al plate, f aulty connection of electrodes, poor conditions of the active electrode and therefore check these factors before increasing the power.

13Use the bipolar technique for operating on small portions of tissues or in cavities.

14When the unit is in use, don’t touch with the active electrode the neutral one (short circuit) and try to avoid the activationwhen the active electrode doesn’t touch the tissues – it might damage the unit or r educe itslife. Please respect the suggested working times.

15Contact the Technical Department for the use of “disposable” electrodes.

16In case lack of supply mains, turn off the unit (setting output power at ZERO).

17Pay attention that the fault of the HF unit might cause an unexpected power increase.

POSITIONING OF THE PATIENT AND USING OF NEUTRAL PLATE

By using monopolar technique, it is v ery important that all the currents reach ing the patient must return to the unit via the eutraln plate, otherwise two serious consequences will be encountered:

1. HF current d ischarges from th e patient throughan insufficient part of the same neu tral plate or via casual contacts of conductive objects (operating table, wet clothes, supports and etc.), since these contact surfaces can be insufficient, the current crossing them may cause some burns.

2.Output power may lower considerably

Therefore use and position the neutral plate respecting the par. “General Precautions”.

Remember that, using a HF unit, it may occur phenomena generally named as “shocks” but these phenomena are normally only stimulations or radiofrequency discharges depending on the same contact between the operator and the patient. In case they happen it is advisable that the operator avoids the direct contacts with patient (e.g. use surgical gloves as insulating) and, if possible, has not ground contact (use clogs, insulating chair, and so on…).

SAFETY CIRCUIT OF THE NEUTRAL PLATE

The unit is equipped with the neutral plate connection control circuit that, when the monopolar performance is selected, blo cksthe output power (if the neutral electrode is not connected or the relevant cable is broken) with specific alarm (intermittente sound and red light).

This circuit doesn’t occur when the bipolar coagulation is selected but the red light signal is put on.

WAY TO USE AND PRATICAL PROPOSALS

1.Check the power supply mains (it must correspond with the tech nical data at the back) and connect the device with main switch1() position OFF. Connect the pedal switch tubing (socket3 at the back) crew tightly the connectorwithout pushing on the pedal (the mod. 140/D is provided with 2 sockets for the double pedal switch and the connection must be performed as follows: yellow tubing of the double pedal to the left socket with yellow area, blue tubing of the double pedal to the right socket with blue rea ). The pedal is pneumatic type, without electric current, waterproof and explosion proof.

2.Connect the electrodes as follows:

-neutral electrode (socket 6) and active electrode (socket 7)

Modd. 140 and 140/D: hand-switch pencil (7A) pedal-switch pencil (7B). For endoscope cables and etc. use only socket 7B, if neccessary ask for specific adapters.

-Bipolar electrode (socket 8 without any polarity of the pins)

The ALSA standard bipolar cable has this following connector:

3.Put on the unit by the switch 1

4.Set up the initial power as follows:

-modd. SU 100 and SU 50 by control 5,

-modd. SU 140 and SU 140/D b y control5A (pure cut or blen d cut), and control5B (coagulation, micro-coagulation, bipolar coagulation).

5.Select the performance by selector 4 and activate the output as follows:

modd. SU 100 and SU 50 ............	(selector 4 - position: cut, blend, coag., micro coag., bip. coag.) activation by single pedal switch;
mod. SU 140/D ............................	(selector 4 – position: cu t/ coag., cut/micro coag., blend/coag.,)activation by hand switch pencil

or double pedal switch (yellow for cut, blue for coagulation);

(selector 4 – position: bip. coag.) activation by only the pedal switch (blue);

mod.140 ................................SU (selector 4 – position: cut/coag.) activation by hand switch pencil;

(selector 4 – position: cut, blend/coag., micro coag., bip. coag.) activation by single pedal switch. The activation is indicated: cut/blend by yellow light and low acoustic signal, coag./micro coag. by blue light and high acoustic signal, bipolar coag. by blue light and louder acoustic signal.

To optimize the running of the units follow the following general indications:

1. Do not a ctivate the unit before touching the tissues by the active electrode (otherwise they will creat electric arcs able toroducep eschar on tissue and preventing them from good cicatrization).

2.Keep the active electrode as clean as possible. The patina insulating on an electrode doesn’t permit a good contact with the tissues, thus it lowers the output power and causes sparks or superficial carbonizations.

MN SU-MPC ING March 2008

Page 2 of 9

3.Using the pure cut (especially with the loop/conization electrodes) if the first effectis not satisf actory (with a slight sticking of the tissue on the electrode), to have the best result increase the power of 10÷15 W each time.

Pure cut	(for biopsy, laparoscopy, cut or skin incision, uterine conization in gynaecology etc., in general for any
	case needing cut without coagulating effect).

1.Use small size electrodes, such as for ex.:

• “thin needle electrode” (from 3÷4 W onwards)

	• SAD, SAD/1, SAD/2, SAD/3 “extra-f ineneedle electrod es” not insulated with diam. from 0.10 to 0.40 mm (from 3÷4		W
	onwards)
	• “fine loop electrodes” of different measures and shapes (from 8W onwards).
	• “long type electrodes” and “LLETZ type electrodes for gynaecology” (from 10W onwards)
2.	Select “CUT” current
Cut coagulating		(for laparoscopy, polypectomies or papillotomies in endoscopy, fistulas, haemorrhoids and ect. In
		general for any case needing cut combined with an effective coagulating effect).

1.Use the electrodes already mentioned for pure cut or, if possible, the ones with larger section, such as for ex.: knife and thick needle electrode (from 3÷4 W onwards)

2.Select “BLEND” current and sl ow a little th e sliding of the electrode on the tissue . If coagulati ng effect is not enough, useeven “COAG.” current.

Micro coagulation

1.Use extra fin e needles: AID “in sulated needle” (the best fordepilation), all the above mentioned “SAD” long ty pe, not insulated needles for depilation, telangiectasia, spider naevi, pointformed red-ruby angiomas and ect.

2.Use ball electrodes to obtain deep effect avoiding as much as possible a surperficial sparking.

3.Select “COAG MICRO” current (from 0.5 Watt onwards)

Coagulation

1.Use ball electrodes, surgical forceps for coagulation with effective deep effect and good surperficial effect (fulguration).

2.Use small ball, needle, loop or for polipectomy electrodes, etc. to obtain strong superficial effect and limited deep effect.

3.Select “COAG” current (from 2-3 W onwards).

Bipolar coagulation

1.Use bipolar forceps or bipolar electrodes (also for laparoscopy or endoscopy, eventually supplied by the other manufacturers).

2.Select “BIP” current (from 2-3 Watt onwards)

3.Please remind that, to reduce the “sticking phenomena” of the tissue on the tips of the bipolar forceps during the operation, it is very useful to clam them as little as possible, reduce at maximum the time of activation and moisten them by physicological solution(or plunged inside a cup or on an imbibed gauze).

AUTOTEST

The running of the unit is completely controlled by microcontroller both durin g the working and when switching on (starting autotest which, if regu lar, ends with short acoustic signal). If an y failure the s ystem getblocked the output giving specific error codes (acoustic signals).

					NO. OF
			TYPE OF FAILURE		ACOUSTIC	SOLUTION
					SIGNAL	Turn off and re-switch on the unit (if the problem
	1.	me	mory	RAM	1
						continues, contact the technical assistance)
	2.	CRC control software			2	“
	3.	variables of the system			3	“
	4.	supply voltage of microcontroller			4	“
	5.	act	ivation	circuits	5	“
	6.	output power higher than the selected value			6	“
	7.	incorrect use of the selector 4			7	Check the position of the selector
	8.	got broken control 5			8	As specified for Fault 1
	9.	continuous activation for more than 20s			9	Deactivate and reactivate immediately
	10.	R.F. modulation signal			10	As specified for Fault 1
	11.	monitoring of the output current			11	“
	12.	monitoring of R.F. supply			12	“
	13.	watchdog		timer	13	“
						Check the connection of the plug and the cable (bend
	14.	intervention of neutral plate safety circuit			intermittent	and pull it, especially near the plug and the electrode).
					(grave)	If the problem continues, contact the technical
						assistance)
	15. usage error (eg. Activation of cut function if				Intermittent
		selecting BIP or activation of 2 switches				Eliminate the cause
					(acute)
		comtemporally)

Furthermore the following cases may occur:

1. the unit is ON (autotest OK), but when you press the pedal switch, does not work (without acoustic or ligh t signals) or works irregularly.

a)	check if the pedal is well connected;
b)	check if the pedal is broken b y activating the un it pushing th e central ho le of th e relevant socket with a roun d
	point. If the unit works regularly it is probably a problem of pedal.

2.the unit is ON (autotest OK), all the running is OK, but there is not output power or it is lower than the normal value.

a)check the good contact of the neutral plate (if the contact is bad or absent there is no power). Remember that the hair of animals is insulating.

MN SU-MPC ING March 2008

Page 3 of 9