Gima DIATERMO MB 80 D User Manual
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Gima DIATERMO MB 80 D User Manual

Gima DIATERMO MB 80 D User Manual

Electrosurgical unit
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DIATERMO MB 80 D-120 D-160 D
ELECTROSURGICAL UNIT
USER MANUAL

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Summary of Contents for Gima DIATERMO MB 80 D

  • Page 1 DIATERMO MB 80 D-120 D-160 D ELECTROSURGICAL UNIT USER MANUAL...

  • Page 3: Table Of Contents

    SUMMARY IMPORTANT ............................1 INTRODUCTION ..........................2 INTENDED USE/ FIELDS OF APPLICATION ............2 INTENDED USER ......................3 INTENDED PATIENT POPULATION ................. 3 STANDARD AND OPTIONAL COMPOSITION ............ 3 DESCRIPTION ........................7 ELECTROPHYSICAL PRINCIPLES ....................8 OPERATIVE TECHNICS ....................13 MONOPOLAR CUT ......................
  • Page 4 FRONT PANEL ..........................43 OPERATION MODE ..................... 44 BACK PANEL ........................... 47 TECHNICAL CHARACTERISTICS....................49 HARDWARE REQUIREMENTS ................. 50 MAINTENANCE ..........................51 GENERAL ......................... 51 CLEANING OF THE CABINET ................... 51 CLEANING AND STERILIZATION OF THE ACCESSORIES ITEMS ....51 TROUBLESHOOTING GUIDE ......................

  • Page 5: Important

    IMPORTANT These instructions are a fundamental part of high-frequency surgery equipment, as they describe its operation and use; Therefore, they must be read carefully before starting the installation and use of the equipment. All safety instructions or warning notes must be observed. Rest assured that these operating instructions are provided with the equipment when it is transferred to other operating personnel.

  • Page 6: Introduction

    The DIATERMO MB 80 D-120 D-160 D equipment are designed to be used in the following sectors: DIATERMO...

  • Page 7: Intended User

    INTENDED USER Device for professional use. Use of the equipment is restricted to medical personnel with medical degrees specializing in high frequency electrosurgery. INTENDED PATIENT POPULATION Adults - Men and Women (≥18 years), excluding patients present in the section "Contraindications". STANDARD AND OPTIONAL COMPOSITION DIATERMO DIATERMO...
  • Page 8 DIATERMO MB Code Description 80 D 120 D 160 D NEUTRAL - Neutral metal electrode 120x160mm with 00401.02 ○ ○ ○ autoclavable cable NEUTRAL - Neutral metal electrode 240x160mm with 00401.03 ○ ○ ○ autoclavable cable 00401.10 NEUTRAL - Neutral electrode steel FLEX 120x210mm ○...
  • Page 9 DIATERMO MB Code Description 80 D 120 D 160 D 152-112 ELECTRODE - 7cm Curved blade electrode ○ ○ ○ 152-115 ELECTRODE - Blade electrode 16 cm ○ ○ ○ 152-120 ELECTRODE - Needle electrode 7 cm ○ ○ ○ 152-122 ELECTRODE - Curved needle electrode 7 cm ○...
  • Page 10 DIATERMO MB Code Description 80 D 120 D 160 D 500500.L10/ ELECTRODE - Spherical angled electrode ⌀ 3mm ○ ○ ○ (5Pcs) 10cm 500500.L11 Microsurgery needles (10Pcs) ○ ○ ○ 500500.L2 ELECTRODE - Fine wire angled electrode (5Pcs) 5cm ○ ○...

  • Page 11: Description

    DESCRIPTION The DIATERMO MB 80 D-120 D-160 D electrosurgical devices can deliver currents suitable for cutting, coagulated cutting, and coagulation, both in monopolar and bipolar modes. These currents can be delivered for the entire duration of the output circuit activation.

  • Page 12: Electrophysical Principles

    ELECTROPHYSICAL PRINCIPLES In electrosurgical interventions the traditional use of surgical blade is substituted by an electrosurgical needle that allows for fast and effective cut and coagulation of the targeted tissue. The electrosurgical needle operates on the principle of converting electrical energy into heat and consists of the following components: A radiofrequency sinusoidal oscillator (0.4 - 4MHz).
  • Page 13 Joule Effect In biological tissue, when passed through by the electric current delivered by the electrosurgical scalpel, heating (Joule effect) is produced, which is dependent on tissue-specific electrical resistance, current density, and application time and can result in various cellular transformations. Q = I x R x T The influence of the thermal effect (Joule effect) is realized by:...
  • Page 14 Characteristics of the tissue • The resistive characteristics change according to the biological tissues. Biological Tissue Metals (range from 0,3 to 1 MHz) Blood 0,16 x 10 Silver 0,16 x 10 ꭥ ꭥ Muscle, kidney, heart 0,2 x 10 Branch 0,17 x 10 ꭥ...
  • Page 15 Mixed currents • These are obtained by combining the effects of coagulation and electrotomy. A reduction in bleeding occurs during a cutting procedure, or as a cut that develops a substantial layer of eschar. The high frequencies used by the electrosurgical scalpel, however, do not allow the electromagnetic field to penetrate matter and cause the current to flow through the conductor more on the outermost surface, decreasing exponentially and becoming negligible in the center of the...
  • Page 16 The physiological system of stimulus transmission follows a limiting curve in which pulsed or low-frequency currents generate a pacing pulse. With the high-frequency alternating current (above 200 kHz), which is used in electrosurgery, there are no neuromuscular reactions (the change of polarity is so fast that it does not affect the patient at the level of neuro-muscular reactions), let alone electrolyte damage to the body.

  • Page 17: Operative Technics

    OPERATIVE TECHNICS MONOPOLAR CUT Monopolar cutting is a technique used to dissect biological tissue by directing a high-frequency, high-density electrical current from the active electrode's tip. This current generates intense molecular heat within the cells, causing them to rupture. As the electrode moves through the tissue, it shears and destroys cells sequentially. This movement prevents the lateral spread of heat within the tissue, confining the destruction to a single line of cells.

  • Page 18: Monopolar Coagulation

    MONOPOLAR COAGULATION When an increase in temperature occurs, caused by the heat generated through the Joule effect in the tissue, thermal coagulation takes place. This process involves the partial solidification of organic liquids and the precipitation of colloidal substances. Specifically, within the blood, fibrin forms, which, as it solidifies, can obstruct blood vessels.
  • Page 19 a more jagged cut, greater depth of tissue destruction, but more effective coagulation. The following rules help the operator achieve good coagulation: Select a ball electrode or a thick wire electrode. • Locate the bleeding vessel after excess blood has been dried from the area. •...

  • Page 20: Bipolar Coagulation

    BIPOLAR COAGULATION In contrast to the monopolar technique, the bipolar technique focuses the high- frequency current on a very small portion of tissue. This method employs bipolar forceps with various sizes and shapes on their distal ends, serving as both the active and neutral electrodes.

  • Page 21: Contraindications

    CONTRAINDICATIONS The use of electrosurgery is contraindicated in patients: pacemaker carriers • with stimulation electrodes • with metallic prostheses • with serious blood pressure imbalances • with serious diseases of the nervous system • with serious kidney failure • in state of pregnancy. •...

  • Page 22: Safety

    SAFETY WARNING: Electrosurgery carries inherent risks, and improper usage of any component within the electrosurgical system can result in severe burns to the patient. It is absolutely crucial that you meticulously read and comprehensively understand all instructions before attempting to utilize an active electrode. Neither the manufacturer nor any retailers can be held liable for any harm or damage, whether direct or indirect, caused to individuals or equipment due to the incorrect use of the device and its accompanying accessories.
  • Page 23 INSPECT instruments and cables for damage before each use, especially the • insulation of laparoscopic/endoscopic instruments. This inspection can be carried out visually under magnification or with a high-voltage insulation testing device. Insulation failures can lead to burns or other injuries to the patient or the operator.
  • Page 24 settings may indicate improper neutral electrode application or poor contact in its connections. This unit has a CQM system; please note that the loss of secure contact • between the neutral electrode and the patient will not trigger an alarm unless a compatible monitoring neutral electrode (split neutral electrode) is used.

  • Page 25: Precautions

    PRECAUTIONS The following precautions are crucial for minimizing the risk of inadvertent burns: Ensure the secure and complete attachment of the neutral electrode to the • patient's body, preferably at the extremities and as close to the surgical site as possible.
  • Page 26 If you encounter difficulty in correctly applying the neutral electrode, consider • using the bipolar technique instead of the monopolar approach, if feasible. To prevent the patient from coming into contact with earthed metallic parts or • components with significant grounding capacity (such as an operating table or supports), use an antistatic drape for this purpose.
  • Page 27 Consider utilizing bipolar techniques when operating on body parts with a • relatively small cross-sectional area. This helps prevent unintended coagulation. Set the output power level to the lowest effective setting for the intended • purpose, minimizing the risk of excessive tissue damage. If the electrosurgical unit exhibits an obvious low output level or operates •...
  • Page 28 systems, and navigation systems. To prevent interference, you must maintain a minimum distance of at least 1.5 meters between the electrosurgical equipment and other devices. Regularly inspect accessories, with special attention to electrode cables and • any endoscopy accessories, to ensure there is no damaged insulation or other defects that could compromise their safety or effectiveness.

  • Page 29: Installation

    INSTALLATION Electrical safety is guaranteed only when the equipment is correctly ▪ connected to a reliable power supply network with proper grounding, in compliance with current safety standards. It is essential to ensure this fundamental safety requirement, and if there are any doubts, seek a comprehensive inspection of the system by qualified personnel.
  • Page 30 Modifying or attempting to modify the equipment is dangerous and should ▪ not be done. Altering the characteristics of the equipment can lead to unsafe operation and potential hazards. Before performing any cleaning or maintenance procedure, disconnect the ▪ appliance from the electrical supply by either unplugging it from the mains or turning off the main switch of the system.

  • Page 31: Patient Safety

    PATIENT SAFETY During high-frequency electrosurgery procedures, it's crucial to understand that the patient becomes a conductor of electrical voltage relative to the earth potential. Consequently, if there is contact between the patient and electrically conductive objects (such as metal objects, damp or wet sheets, cloths, etc.), it can result in the generation of electric current at the point of contact.

  • Page 32: Correct Application Of The Neutral Electrode

    CORRECT APPLICATION OF THE NEUTRAL ELECTRODE In monopolar electrosurgery, the use of a neutral electrode, also known as a current leakage plate, is essential. It facilitates the safe return of the cutting or coagulation current to the electrosurgical unit. There are two types of neutral electrodes: Monopolar Neutral Electrode: In this type, there is no control over the contact between the neutral electrode and the patient.
  • Page 33 For both single-part and dual-part electrodes, before proceeding with the placement of the neutral electrode, clean and remove any residues of foreign substances from its surface. Do not apply the neutral electrode on scars, bony prominences, or anatomical areas where prosthetic implants or monitoring electrodes are present. Instead, apply it on well-irrigated tissues, such as muscles and in proximity to the surgical site.

  • Page 34: High-Frequency Electrosurgery In Laparoscopy

    HIGH-FREQUENCY ELECTROSURGERY IN LAPAROSCOPY Laparoscopic surgery, or minimally invasive surgery, has revolutionized the field of surgical procedures, bringing significant benefits in terms of patient recovery times and healing. In this context, the use of high-frequency monopolar surgery (HF) is widely employed due to its flexibility in performing cuts, coagulations, and mixed cuts that combine both functions.
  • Page 35 hazardous than a major one, as it concentrates the current, making burns more likely. Capacitive Coupling: This occurs when the active electrode induces electrical current in conductive materials, even if the insulation remains intact. During high frequency electrosurgery, the rapid changes in the electric field around the active electrode are only partially hindered by insulation, generating ionic currents that, upon contact with tissue, can cause sufficient heating to induce burns.

  • Page 36: Putting Into Service

    In conclusion, burns are a genuine concern in high frequency electrosurgery procedures. However, with a deep understanding of potential causes and thorough preparation of the medical team, it is possible to limit their occurrence and effectively manage potentially risky situations. PUTTING INTO SERVICE Inspect the equipment for any damages caused during transportation.
  • Page 37 Connect, if necessary, the equipotential bonding point on the back of the unit • to the potential bonding socket in the system. Connect the single pedal or optional double footswitch to the connector on the • front of the equipment. Connect the handpiece with two buttons;...

  • Page 38: Meaning Of Graphic Symbols

    MEANING OF GRAPHIC SYMBOLS N° SYMBOL DESCRIPTION Floating neutral electrode: not connected to ground at either high or low frequencies. CF Class equipment protected against defibrillator-induced discharge. Non-ionising radiation generator equipment. Follow the instructions for use. CE Mark (2017/745/EU) + Notified Body Number 0051 = IMQ Italy. The product should not be disposed of in urban waste containers but must be disposed of through separate collection.
  • Page 39 N° SYMBOL DESCRIPTION FRAGILE – Handle With Care. Keep away from sunlight. Protect against moisture. Number of maximum stackable packages. Weight. Dimensions. Number of Pieces. Recycle. Model/Trade Name. Protection against harmful ingress of water or particulate matter. Fuse.

  • Page 40: Box Label

    BOX LABEL With reference ISO15223-1 “Medical Devices-Symbols to be used with medical device, labels, labelling and information to be supplied” and ISO780 “Packaging – Pictorial marking for handling of goods” on box label of UNIT’s carton box are present these indications: ISO15223-1 (5.1.1) MANUFACTURER 12.

  • Page 41: Connection Of Accessories

    CONNECTION OF ACCESSORIES For the correct connection of accessories, please refer to the images below. Footswitch connector: On the left side of the front panel, there is the socket for connecting the footswitch or optional double footswitch.
  • Page 42 Connector for neutral electrode: On the front panel is the connection point for the neutral electrode or the optional adapter (REF 00498.00) in case of using the BIPOLAR function.
  • Page 43 Handpiece connector: On the front panel is the connection point for the handpiece. In case of using buttonless handpieces (optional), they must be connected to the 'ACTIVE' section of the connector.

  • Page 44: Use Of Accessories

    USE OF ACCESSORIES Use for MONOPOLAR: Holder-handle with two pushbuttons without foot switch: press the yellow pushbutton on the holder-handle to deliver the cutting current (the choice between CUT or BLEND must be done pressing the correspondent pushbutton on the unit); or the blue pushbutton on the holder handle to deliver coagulating current (the choice between FORCED COAG, SOFT COAG or BIPOLAR must be done pressing the correspondent pushbutton on the unit).
  • Page 45 Holder handle without pushbuttons (optional) and single foot switch: connect the holder handle to the buckle indicated “ACTIVE” and pre-set the current for the cut (CUT or BLEND) or the coagulation (FORCED COAG, SOFT COAG or BIPOLAR), press the foot switch to deliver the pre-set current.
  • Page 46 Bipolar forceps and double foot switch: connect the optional adapter (REF 00498.00). The equipment will select the BIPOLAR operative mode. To deliver the current press the foot switch for the coagulation (blue). To avoid the forceps’ damage don’t make short circuit with its tips.

  • Page 47: Front Panel

    FRONT PANEL Knob for adjusting the output 8. Selection button and indicator light power level of the CUT for BLEND cut function function 9. Selection key and relative indicator Indicator for adjusting the light for FORCED COAG surface output power level of the CUT function function 10.

  • Page 48: Operation Mode

    OPERATION MODE SWITCH ON When switched on the electrosurgical unit automatically performs a test to establish the correct operation of itself and of the connected accessories as well. In case anomaly is found an alphanumeric message it is shown coded according to the chart codes brought in the chapter MAINTENANCE.
  • Page 49 Coagulated-Cut Current (BLEND) The coagulated-cut current (BLEND) is designed for coagulated cuts when a deep coagulation along with the cut is desired. This current combines a sine current for the cut with a low-voltage current suitable for coagulation (SOFT COAG). The resulting blend creates a current suitable for coagulated cuts without eschar and carbonization, making it particularly well-suited for endoscopic surgery.
  • Page 50 SIGNALING OF EXCESSIVE TIME OF DELIVERY (OVT) If the operator exceeds the maximum delivery time of 10 seconds, the equipment might, after a variable period depending on the type and level of delivery, generate a warning signal indicated by a flashing "Hot" on the displays, and it will prevent further delivery.

  • Page 51: Back Panel

    Sound emission until 1m Level distance from the frontal panel 55 dBA 60 dBA 65 dBA 70 dBA 75 dBA AUTOMATIC CONTROL OF THE INTERNAL PARAMETERS The equipment is equipped with a continuous automatic control system for certain internal parameters. Upon startup, it performs a check, indicated on the displays with the message 'SEL FCh' followed by the result, which appears as 'PAS Sed' if the system detects no irregularities or, alternatively, through an error code notification in the form 'Err xxx'.
  • Page 52 POWER SUPPLY MODULE AND VOLTAGE SELECTOR The power module of the equipment represents the connection point for the internal electronics power. This module includes the power connector and line fuses, with the voltage selector located inside. CAUTION: Before turning on the equipment, the operator should ensure that the mains voltage indicated on the voltage selector matches the connected voltage, and appropriate fuses for the selected voltage are inserted.

  • Page 53: Technical Characteristics

    TECHNICAL CHARACTERISTICS DIATERMO DIATERMO DIATERMO MB 80 D MB 120 D MB 160 D Electrosurgical Unit Code GMA10100.101 GMA10100.201 GMA10100.301 DIATERMO MB Tol. Descrizione 80 D 120 D 160 D ± 0% Minimum presectable power Level step Digital level display ●...

  • Page 54: Hardware Requirements

    DIATERMO MB Tol. Descrizione 80 D 120 D 160 D Five steps adjustable sound level (from 55- to ± 5 ● ● ● 75dBA) Self-check ● ● ● Power accuracy output warning ● ● ● Split or not split patient plate allowed ●...

  • Page 55: Maintenance

    MAINTENANCE GENERAL Inside the equipment, there are no user-adjustable parts for calibration or maintenance. The equipment housing should not be opened, as any unauthorized tampering with the unit invalidates the warranty. In case of repair or adjustment needs, the entire apparatus should be sent to the LED SpA service center in APRILIA (LT) - ITALY, along with a description of the malfunction.

  • Page 56: Troubleshooting Guide

    TROUBLESHOOTING GUIDE In case of problems before all you must check for the correct installation of the unit and for the correct connection of the accessories. Problems Probable Cause Solution The equipment doesn't Interruption or absence of Verify the connection of the main switch on.

  • Page 57: Repairs

    REPAIRS High frequency cables and electrode holder handle cannot be repaired. Always substitute a damaged part with a new one. FUSES SUBSTITUTION Before substituting the fuse, disconnect the unit from the mains system. Only use fuse of the kind 5x20; they must have those characteristics: T3.15A (slow) (230Vac mains voltage), T6.3A (115Vac mains voltage), proceed as follows: (A-B) Extract the fuse holder drawer from the power module.

  • Page 58: Checking Of The Equipment Before Each Use

    CHECKING OF THE EQUIPMENT BEFORE EACH USE Each time the use of the electrosurgical equipment is planned a check of the most important safety aspects must be implemented considering at least the following: Check the integrity of cords, connections, wires breakage, etc. •...

  • Page 59: Diagrams

    DIAGRAMS DIATERMO MB 80 D Maximum and average power diagram on Maximum and average power diagram on Maximum and average power diagram variable load 100-2000 CUT variable load 100-2000 BLEND on variable load 100-2000 FORCED Maximum and average power diagram on...
  • Page 60 DIATERMO MB 120 D Maximum and average power diagram on Maximum and average power diagram on Maximum and average power diagram variable load 100-2000 CUT variable load 100-2000 BLEND on variable load 100-2000 FORCED Maximum and average power diagram on Maximum and average power diagram on CUT output power diagram on nominal variable load 100-2000...
  • Page 61 DIATERMO MB 160 D Maximum and average power diagram on Maximum and average power diagram on Maximum and average power diagram on variable load 100-2000 CUT variable load 100-2000 BLEND variable load 100-2000 FORCED Maximum and average power diagram on Maximum and average power diagram on CUT output power diagram on nominal variable load 100-2000...
  • Page 62 Information related to the reduction of hazardous substances in electrical and electronic equipment, as well as waste disposal. At the end of its life, this product must not be disposed of as municipal waste; it should be subject to separate collection.
  • Page 64 Official Dealer GIMA SPA Via Marconi 1 - 20060 Gessate (MI) - ITALY Tel +39 02 9538541 Fax +39 02 95381167 www.gimaitaly.com gima@gimaitaly.com - export@gimaitaly.com...

This manual is also suitable for:

Diatermo mb 120 dDiatermo mb 160 d

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