ALSA ALSATOM MB1 MC Instruction Manual

This unit is manufactured by ALSA APPARECCHI MEDICALI S.R.L.- CASTEL MAGGIORE - BOLOGNA - ITALY that answers for safety, reliability and
performances only if the installation, additions, recalibrations, changes or repairs are effected by personnel authorized by ALSA and if the installation,
additions, recalibrations, changes or repairs are effected by personnel authorized and only if the installation takes place in a room complying with relative
prescriptions IEC or CEI and the unit is used in compliance with given instructions.
The Manufacturer will supply, on demand, the electric diagrams and will supply any further information needed.
These instructions must be kept where the unit is employed, must be read from the operator before use and ask for them again to the Manufacturer
in case missing.
If the instructions are not exhaustive for the specific field, please contact the Manufacturer directly or through the local distributor, before using the unit.

IMPORTANT

Every unit has specific features and so, before using it with a patient it is advisable to check carefully its working without trusting blindly to the previous
experiences with others similar units.

VERY IMPORTANT

In accordance with the requests of the European directive for medical devices 93/42 CEE and according to the procedures of company quality system
for the after-sale control of the production, the users have to inform, in detail, the Manufacturer about every little problem of this unit in order to
attend it in a short time.

INTRODUCTION

In a biological tissue which is crossed by an electric current, are shown the following effects:
- Thermal - related to the specific resistance of the tissue, to current density and length of phenomenon;
- Faradic - due to the stimulus of electrically excitable cells.
- Electrolytic - for which in the tissue positive ions are pushed towards negative pole and vice versa
By using high-frequency alternate electric current, are eliminated two last not desired effects, taking best advantage from thermal effect.
In fact, when an electric current having such characteristics, flowing from active electrode to the neutral one, crosses with sufficient density the cellular liquid
of the tissues warms it by producing as follows:
1) Heating is so quick that the pressure of created vapour in the cells breaks the membranes causing cutting;
2) Heating is lower, so the liquid slowly evaporates allowing coagulation of the tissue components which can be coagulated (coagulation or haemostasis):
3) The phenomenon is middle course between above said (blend cut).
Therefore, the electrosurgical units are 'high frequency units' which allow to 'destroy' cells of biological tissues, so they must be handled by expert staff only
who knows very well all problems and risks concerning their use following, for safety, all instructions supplied by the Manufacturer.

INSTRUCTIONS TO USE THE UNIT

ALSATOM models MB1-MC and MB1/A-MC designed for use in the field of minor and medium surgery, for all the operations that need powers not more
than 150 Watts for the cut and monopolar coagulation and 60 Watts for the bipolar coagulation combined to a very fine and precision in the power delivery.
Units are suitable for:
- GYNAECOLOGY: ......................................................for every kind of cut and coagulation or micro coagulation.
- DERMATOLOGY: .....................................................for every kind of cut and coagulation or micro coagulation.
- PLASTIC AND AESTHETIC SURGERY:................for every kind of cut and coagulation or micro coagulation.
- OTORHINOLARYNGOLOGY:.................................for every kind of cut and coagulation or micro coagulation.
- UROLOGY: ..................................................................not for endoscopy use under liquid except for fulguration.
- DENTAL SURGERY AND MAXILLO-FACIAL:....for every kind of cut and coagulation or micro coagulation.
- ANGIOLOGY: .............................................................for every kind of cut and coagulation or micro coagulation.
- GENERAL SURGERY:...............................................for every kind of cut and coagulation or micro coagulation.
- SPECIALITY SURGICAL:.........................................for every kind of cut and coagulation or micro coagulation.
- GASTROENTEROLOGY: .........................................for every kind of cut and coagulation or micro coagulation.
- VETERINARY:............................................................for every kind of cut and coagulation or micro coagulation.
In particular, functions are the following:
- CUT: ............................................................................pure cut without coagulant effect;
- BLEND:.........................................................................cut with coagulant effect;
- FORCED COAG: .........................................................coagulation with an high scintillation (fulguration);
- SOFT COAG: ...............................................................coagulation with a low scintillation and a marked action into the depths (desiccation);
- BIPOLAR: ....................................................................bipolar coagulation;
GENERAL PRECAUTIONS, it's dangerous to not comply with the following:
1. It's dangerous to use the unit if the electric system and the installations of the operating theatre do not comply with the safety standards in force:
Do not use 'extensions' for the supply cable and when use at the same time several apparatuses ask to Technical Office for the compatibility.
2. It's dangerous to use old accessories or not supplied by the Manufacturer.
3. The interference on other electromedical equipments is regular when apparatus works.
4. Please remind that when operate on patient wearing pace-makers or pace-maker electrodes, these last may be troubled or damaged (to cause
fibrillations and so on)(Please address you to the Cardiology Dep.).
5. Take off all metal items from the patient: rings, chains and so on and don't use the unit with inflammable anaesthetic gas (ex. oxygen and nitrous
oxide and so on) especially in case operate in cavities (thorax, abdomen, trachea, head, and so on)
6. Don't use or evaporate, before the operation, cleaning substances, disinfectants or inflammable solvents. Always carefully remove any possible
stagnation from body's depressions or cavities (navel, vagina, and so on) as well as under the patient. Remind that during the use a spark may cause
the burst of endogenous gas (intestine) or set materials saturated with oxygen (cotton, gauze and so on) on fire.
7. Avoid the touch of earthed metal parts or electricity conductors with the patient (tables, supports et cetera) and insulate the body's parts at strong
secretion and the skin to skin contacts (for ex. between arm and body) by means of dry cloth.
8. Always keep eventual monitor electrodes not properly protected as much as possible away from those of electrosurgical unit. It's certainly advisable
against using needle monitor electrodes or small size electrodes.
9. Set neutral electrode as follows:* Check its perfect conditions and choose the nearest body's part to the operating area (the best is a soft part, without
hairs, osseous protuberances or superficial inhomogeneity). Clean, shave and massage it to help the circulation.
* Set the electrode very well without interpose anything making sure the best possible contact on the whole surface, but without pushing too much to
not create ischaemic zones (use, in case, conductive gel and so on) and always check during the operation good and homogeneous contact at all time
ALSATOM MB1 MC, ALSATOM MB1/A MC
INSTRUCTION MANUAL
(Edition January 2002)
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