BM VET 80, 120, 140, 180 W

Transcription

1 Special Medical Technology, Ltd. VETERINARY RADIOFREQUENCY Electrosurgical Units SMT BM VET 80, 120, 140, 180 W 1014 Operating Instructions

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3 Special Medical Technology, Ltd. CONTENT: 1. INTRODUCTION Principles of Safe Use GENERAL INFORMATION How does it work? Good techniques and tips Cutting Blend Cut Coagulation Electrosurgery main advantages ELECTROSURGICAL SYSTEM SMT BM VET Control Unit Surgical Tool - Applicator The Electrodes - Surgical Instruments Neutral Electrode (Ground Plate or Patient Plate) Foot-Operated Switch TECHNICAL DESCRIPTION AND CHARACTERISTICS The Electrosurgery Unit Applicator, Handpiece Neutral Electrode Pneumatic Foot Switch Electrodes and Accessories INSTALLATION AND SETUP MAINTENANCE Sterilization Cleaning Troubleshooting and Repairs Preventative Inspections THE FULFILMENT OF LEGISLATIVE REQUIREMENTS ELECTROSURGICAL UNIT AND SUPPLIED ACCESSORIES The basic accessory: Optional accessories: LIMITED WARRANTY...20 INDEMNITY AGREEMENT FINAL USER REGISTRATION CARD 3

4 Manufacturer: Special Medical Technology, Co. Ltd. Papírenská 114/ Prague 6 Czech Republic Phone: , Fax: smt-praha@smt-praha.com, obchod@smt-praha.com Internet: Device classification class:...ii b Device service life:...7 years 1. INTRODUCTION Due to the ongoing development of this device, specifications and technical data may change without previous notice. No part of the following document is permitted to be photographed, copied or translated into other languages without the manufacturer's prior written consent. For engineering or service assistance contact the supplier or representative listed at the back of this manual. It s very important to save this manual for future reference. Make sure this manual is received complete Principles of Safe Use The operation of all high-frequency Electrosurgical instruments presents certain risks. To minimize them safety rules and precautions have to be exercised. For clarity a comprehensive list of these rules is presented here; many of them are repeated later in the text. These instructions were written for your safety and for the safety of other people. Read them carefully before installing and operating this unit to get the best performance and highest level of safety. Only a licensed Veterinarian or person under his supervision is permitted to operate this unit. SMT BM VET 4

5 Use only accessories (active and neutral electrodes) supplied or approved by the manufacturer of the main Electrosurgery unit to prevent incompatibility and unsafe operation. The neutral electrode (ground plate) has to be reliably and firmly connected to the Patient s body with its full contact surface and as close as possible to the surgery area. Do not place any separating material between the neutral electrode and the patient s body. Do not wet or moisture the contact area. The PATIENT must not come into contact with any metallic parts that are grounded or have high ground capacitance (e.g. surgical table, rests, and the like). Use antistatic bed-clothes, gauze or scrim for safe electric insulation. It's necessary to prevent any skin to skin contact (e.g. between a limb and body of a PATIENT) by applying dry gauze or other electrically insulating material. If a high-frequency electrosurgical unit and a monitoring device are used on a PATIENT simultaneously, monitoring electrodes should be placed at the farthest possible distance from the surgical electrodes. Needle monitoring electrodes should not be used. We recommend that monitoring systems that limit highfrequency currents be used. Electrode input cords have to be placed in such a way that any contact with the patient s body or other electric conductors is prevented. Active electrodes when not in use have to be placed safely so they can not unintentionally touch the PATIENT or attending personnel. When performing surgical procedures where high-frequency currents could flow through body parts with relatively small cross-sections, we recommend that the bipolar technique be used to avoid unintentional coagulation. Set the power level to the minimum requirement for a particular procedure to start each elemental surgery and increase power if needed. An incorrectly connected neutral electrode can cause decreased power output and system malfunction. Neutral rubber electrodes lose conductivity over time and that is why its lifespan is limited to 12 months or less. This limitation does not apply to stainless steel neutral electrodes. See chapter 6.4, preventive inspections. If a surgical operation is performed in an area close to the chest or head, the use of combustible anesthetics or oxidizing gases 5 SMT BM VET

6 (e.g. Nitrous Oxide N2O/ and oxygen) must be avoided, unless the vapors are thoroughly exhausted. Incombustible substances have to be used whenever possible. Combustible substances, used for cleaning, disinfection, or as a solvent must be allowed to dry-out before electrosurgery starts. Accumulation of combustible substances under the PATIENT or in the Patient s cavities, e.g. abdomen or vagina, may be dangerous. Before electrosurgery starts any combustible substances have to be removed from these cavities by gauze. Examples of flammable or explosive substances are alcohol, chloroform, cyclopropane, ethylene, etc. Pay close attention to the danger of spontaneous inflammation of endogenous gases. Be aware that sparking is common during surgery and may cause combustion of some substances (e.g. absorbent cotton and gauze saturated with oxygen). The Electrosurgery high frequency unit (when output is active) may interfere with some other sensitive electronic devices and instruments in the vicinity. Place these devices and instruments as far away from the electrosurgery unit as possible. Be especially aware of any electronic implanted devices. Do not use electrosurgery in the presence of anyone having a cardiac pacemaker. Inspect the electrosurgery unit and its accessories regularly for any defects or damages. Pay special attention to the condition of the insulation of all electrode input cords. Any unprofessional service and repairs of the Unit must be avoided. Have all revisions and repairs carried out by the manufacturer authorized service center. To minimize risks and consequences of possible power cut, we recommend using the Unit in operating theatres equipped with stand-by power backup. At ambulatory applications the Unit should be powered from stand-by power supply (UPS). 2. GENERAL INFORMATION For best results it is imperative to understand the principals of electrosurgery. Anyone providing electrosurgery needs to familiarize himself with the following basics. SMT BM VET 6

7 2.1. How does it work? The active electrode, inserted in the hand-piece, concentrates highfrequency energy in the desired spot. A high-frequency current passes through tissue without causing pain or shock. The only effect is generated molecular heat inside cells proportional to the passing current. The heat is so intense that it is possible to cut or coagulate the tissue. The main benefit of electrosurgery is to remove unwanted tissue, prevent bleeding without carbonization or to precisely excise tissue for diagnoses and testing Good techniques and tips It is necessary to exercise all principals of safe use as described in 1.1 above Provide smooth controlled movement of the active electrode so that the heat destroys only a single pass of cells and does not accumulate in one spot Excessive heat could be generated under several conditions: The power level is too high. The movement through the tissue is too slow or is repeated in the same region too soon. Power level is too low and it is difficult to move the electrode through the tissue. The ground plate is separated by wet gauze or scrim and as surgery progresses the gauze starts to dry and decreased conductivity is compensated by a higher power setting The power level set too high dehydrates tissues and causes sparking The power level set too low dehydrates tissues; fibers are not destroyed and stick to the electrode It s recommended to ventilate the electrosurgery characteristic odor Cutting Set the selector knob to CUT. Its position is indicated by a yellow light. The high-frequency current generates molecular heat so intense that it effectively destroys adjacent cells. The electrode passes through the tissue creating an incision without any resistance by the tissue. Controlled, smooth movement of the electrode does not allow the heat to destroy more 7 SMT BM VET

8 that a single pass of cells. The lymphatic vessels and capillaries are sealed and the incision does not bleed. The most suitable current for cutting is a current of high-frequency stabilized and filtered with no modulation. Such a current cuts very smoothly but with little hemostasis. The following rules will help the surgeon provide a good cut. Keep tissue damp but not wet. Move electrode smoothly without stopping. Activate the mono-polar electrode just before touching the tissue. Bipolar see pg. 9. Keep the electrodes clean, free of fibers and carbon. Wait at least 5 seconds before repeated incision. If the power level is set properly than: The electrode moves without resistance. The tissue affected does not change color. Tissue fibers do not stick to the electrode Blend Cut Set the selector knob to BLEND. The position is indicated by a green light. Hemostasis or coagulation is an important benefit of electrosurgery. This is achieved by modulating the high-frequency current Coagulation Set the selector knob to COAG. This position is indicated by a blue light. Coagulation is the hemostasis of small (blood) vessels caused by a highfrequency current. By reducing the current and using a broad-surface electrode the heat dissipates over a larger area. The benefit is that the surface dries out without deep penetration resulting in coagulation. Such a coagulated surface provides an insulation layer which prevents heat from penetrating further into the tissue on successive deeper incisions. The High-frequency current normally used for coagulation is always modulated. The depth of modulation controls the level and quality of hemostasis and the desired level of tissue destruction. If the fine coagulation is suitable use the output Micro-coagulation and set the selector knob to MICRO. This position is indicated by an orange light. The following rules will help the surgeon achieve good results: SMT BM VET 8

9 Select proper electrode size, ball or other. Find bleeding veins. Touch the bleeding vessel lightly and then activate the electrode. Deactivate the electrode as soon as the tissue turns pale Bipolar Coagulation This is done using the bipolar electrode (various style tweezers with two poles) Procedures: Squeeze the bleeding vessel with the bipolar electrode Activate power (using foot switch) Deactivate power and after that release squeeze The bipolar electrodes and cord are supplied as optional Accessories. See manufacturer s catalog Electrosurgery main advantages Loss of tissue is minimized Bleeding is minimized Hard tissue such as bones will not be damaged as long as there is only a moving contact as the electrode passes. Healing is at least as fast as after classical scalpel surgery. The resulting scar is soft and supple. Postoperative pain is decreased since the cut nerves are dulled by the procedure. 3. ELECTROSURGICAL SYSTEM SMT BM VET 3.1. Control Unit The electrosurgery generator is a powerful high-frequency oscillator. Its output current can be modulated to be suitable for incision, coagulation and their combinations. Output power is controlled by a surgeon to fully comply with a particular surgery need. It is adjustable by knob within MIN - MAX range (5) picture 1, pg 15. The unit has two modes, MONOPOLAR and BIPOLAR. In each mode, the high frequency current modulation has 4 settings CUT, BLEND, 9 SMT BM VET

10 COAG and MICRO (incision, cut +coagulation, coagulation and microcoagulation). Micro-coagulation is used for very subtle coagulation Color-Light Indicators - picture 1, pg 15. Green (7) Power is on Green (8) Mode set to MONO or BIPOLAR by switch (3) Yellow (9) Modulation set to CUT Green Modulation set to BLEND Blue Modulation set to COAG Orange Modulation set to MICRO Red (6) CAUTION (alarm) Ground Plate circuitry malfunction 3.2. Surgical Tool - Applicator An applicator (also called a hand-piece) holds the active electrode chosen for a particular procedure. It s wired to a color coded yellow plug which fits to a corresponding color coded receptacle on the front panel (2)-picture 1, pg 15. An applicator is not used in bipolar mode. A miniature applicator is a device which is very often used in microsurgery. It is suitable for micro-coagulation. This applicator holds a special needle that functions as an active electrode The Electrodes - Surgical Instruments The active electrodes concentrate high-frequency current and apply it into tissue. They are of various shapes and styles to suite its use. Straight or loop thin-wire electrodes are usually used for incision. The loop electrodes are used for tissue excision. Ball electrodes are used for coagulation. The standardized chucking diameter of the electrode shank is 2.4 mm. The electrode tip is partly sterilized by high-frequency energy that also destroys germs accidentally occurring in the operation area. Anyhow, most electrodes can be repeatedly sterilized by all conventional methods. Manufacturer recommends sterilization by steam - see Chapter 6.1. The most frequent applications are the incision by scalpel, loop electrode LOOP or needle electrode, and coagulation by ball electrode BALL. (All that supplied by manufacturer of this Electrosurgical Unit.) SMT BM VET 10

11 3.4. Neutral Electrode (Ground Plate or Patient Plate) The neutral electrode closes the circuit and must always be used in monopolar mode. It must be fastened reliably and with its entire contact surface to the patient s body as near as possible to the operation area. See chapter 1.1. It is usually a plate made of metal, conductive rubber, or plastic; dimensions are about 6 x 14 cm or larger. This part of the electrosurgery set is very important. The International Safety Directives require continuous monitoring of the connection to the patient s body. If the neutral electrode is disconnected or if one wire of the two-core connection cord is broken then the warning red light intermittently flickers and the panel sounds an intermittent acoustic signal. The fumction is interrupted. This warning is also activated whenever the electric circuit of the neutral electrode is disconnected in the course of a surgical treatment. If a situation like this occurs the neutral electrode must be replaced. Visual checking of all electrodes and their input connection cords is recommended before each operation. Using the neutral electrode in mono-polar mode is of vital importance for perfect execution of a surgical treatment with the minimum and safest possible amperage, and also for the due operation of the Unit. (An operation without the neutral electrode requires higher output power. Moreover, unless the neutral electrode is correctly used, many various effects, e.g. weight of the patient, conductivity of the patient s skin, and also the position of an attendant, could affect the high-frequency impedance and thus influence the operation of the electrosurgical instrument and in that connection also the surgical treatment.) The neutral electrode must be placed in such a way, that it forms a reliable electrical contact with a part of the patient's body. It s mandatory to observe the principles of safe use outlined in chapter 1.1 above Foot-Operated Switch The foot-operated switch is pneumatic, without any electric cords, therefore highly safe. 11 SMT BM VET

12 4. TECHNICAL DESCRIPTION AND CHARACTERISTICS 4.1. The Electrosurgery Unit Type:...SMT BM VET Power Requirement...220, 230 or 240V, 50/60 cycle, AC...(110/120V available) Max. Power Input: VA Idle Power use:...52 VA Max. effective power: or 120 or 140 or 180 W Working frequency: khz Insulation class...ii Size:...260x250x80 mm (10.3 x 9.9 x 3.2 ) Mass:...3,5 kg Power supply transformer Prim /230V ~ (110/120V available); sec.1=57v; 200 VA; sec. 2 = 16V; CSN EN The unit is internationally certified by the Directive 93/42 EEC, by way of ANNEX II and is labeled with MARK of Conformity CE 0459 and The unit is certified by the procedure of conformability to CSN EN :2007, CSN EN :2007, CSN EN :2003, CSN EN Standards. Used symbols: The unit is type BF with protection against defibrillation discharge, the corresponding symbol is. The unit operates with high-frequency energy with non-ionizing radiation, the corresponding symbol is. The unit operates in MONOPOLAR (symbol ) and BIPOLAR (dual green coded receptacle) modes. Mode is selectable by the toggle switch (3) see picture 1, pg 15. Power output in both modes can be set to any of 4 functions: CUT, BLEND, COAG, MICRO. (incision, incision + coagulation, coagulation and micro-coagulation) Symbol! means: "ATTENTION, consult enclosed documentation" The unit is capable of continuous operation with intermittent load (see chapter 5). The unit uses no dangerous chemicals or materials. SMT BM VET 12

13 Environment Ambient temperature C up to +40 C (+50 F up to F) Relative humidity...from 30% to 75% Atmospheric pressure...from 700 kpa to 1060 kpa Protection against an undesirable water penetration...ip Applicator, Handpiece Insulated electrode holder wired to a color-coded yellow plug accepting standardized 2.4 mm electrodes. Used in Mono-polar mode Neutral Electrode The highfrequency separated contact part of electrode type F, the corresponding symbol F on the front panel of the Unit Pneumatic Foot Switch Diameter mm (4.3 ) Length of connecting tube...3 m (10 ) Weight kg (8.8 oz) Tube connects to inlet on the unit rear panel marked with symbol Electrodes and Accessories An assortment of electrodes is available from the manufacturer as specified in the manufacturer s leaflets. Use only accessories supplied or approved by the manufacturer of the main Electrosurgery unit to prevent incompatibility and unsafe operation. 5. INSTALLATION AND SETUP Under normal conditions when electrical resistance of the tissue is 500 Ohms in mono-polar mode and 100 Ohms in bipolar mode the device can run continually without interruptions. Technical limits of the Unit are defined by the following technique of operation: INTERRUPTED OPERATION - 180/30 (180 sec oper./30 sec interruption) If overheated the unit will automatically turn off and back on again after brief cooling. Place the Unit on a stable surface, sheltered from heat radiation and direct sunlight. Connect the power cord into the receptacle on the rear 13 SMT BM VET

14 panel of the main unit. Plug the other end into a 120 V 60/50 Hz wall outlet. Plug the foot-switch hose into the pneumatic inlet on the rear panel marked with the symbol. The connection must be air tight. Select the desired mode by the MONOPOLAR - BIPOLAR rocker switch (3) - picture 1, pg 15. Selected mode is indicated by light (8). Insert the mono-polar electrode cord into yellow jack (2) or the bipolar electrode cord into green jacks (4). For bipolar mode also insert the connection cord plug of the neutral electrode into its receptacle (1). Push the blue collar and turn clockwise to snap into the locked position. To disconnect pull the gray collar and turn countrariwise. Turn on the power by rocker switch on the rear panel (3) picture 2, pg 16. Power ON is indicated by a green light (7) picture 1, pg 15. Select the operating output function with the selector switch (10). Adjust the estimate of the required Power by knob (5). Activation of an output function is indicated by the respective light signal (9) and simultaneous uninterrupted acoustic signal. WARNING: Accidental disconnection of the neutral electrode in monopolar mode will activate an intermittent acoustic warning alarm and a red CAUTION light (6). This feature controls proper connection of the neutral electrode. SMT BM VET 14

15 Picture 1 - CONTROL UNIT FRONT PANEL Legend: 1 - neutral electrode connector receptacle 2 - monopolar electrode jack 3 - MONOPOLAR / BIPOLAR mode switch 4 - bipolar instrument (tweezers) dual jack 5 - power level setting knob 6 - red light - signals malfunction in the area of the neutral electrode 7 - green light - signals power ON 8 - green lights - indicate position of the M/B mode switch 9 - output functions signal lights 10- output functions selector knob 15 SMT BM VET

16 Picture 2 - CONTROL UNIT REAR PANEL Legend: 1 - pneumatic switch connector 2 power cord socket 3 power switch 4 manufacturer s label 6. MAINTENANCE The Electrosurgical Set doesn't require any special maintenance, except usual cleanup of all parts. Have any needed repairs performed by the manufacturer authorized service center Sterilization The sterilization of all parts which are in contact with the patient - electrode holders, patient neutral electrode, and also surgical electrode - can be done in an autoclave, or by subjecting to formaldehyde or ethyleneoxide. The producer of this device recommends sterilization in an autoclave. Electrode sterilization (LOOP, BALL, scalpel, needle) can also be done by hot air, up to 150 C (302 F). After each sterilization is necessary to do a preventative visual inspection of all connection cords of the operating electrode holder and neutral electrode Cleaning Outside surfaces of the control unit case can be wiped clean with damp gauze using usual detergent. However, do not allow the washing solution to get inside. Scrape off any sticking tissue from electrodes and rinse with water before cleaning with detergent. SMT BM VET 16

17 6.3. Troubleshooting and Repairs Problem: The system is activated but some or all light indicators do not illuminate. Remedy: Have a licensed electrician open the unit to check the 3 internal fuses. Each fuse has a different electric value and corresponding label or imprint is near to each installed fuse. One of each fuse and a special Service Key are supplied with a new unit. In order to remove the top cover, the service key is used to press against internal tabs through rectangular holes on the left and right side. Two of these holes are located just above the cover parting line and two are just below. Do not use any of the 4 blind holes. Problem: The electrode doesn t cut easily, the selected function signal light is on, and the audible uninterrupted signal is on. Remedy: Check for the proper connection of the electrode and the Power level setting. Make sure the neutral electrode is properly used as described in section 3.4 above. Problem: Power on, foot switch activated but function signal light is not lit, audible signal is not active. Remedy: Check for proper connection and air tightness of the foot switch and hose. Make sure all electrodes are properly connected. If this does not solve the problem contact the manufacturer or the authorized service Preventative Inspections Inspect the Control Unit at 12 month intervals. Inspect the connection cords, hand-piece and neutral electrodes at 6 month intervals. See also inspection after sterilization in 6.1. above. 17 SMT BM VET

18 7. THE FULFILMENT OF LEGISLATIVE REQUIREMENTS The conformity was reviewed with the product. The manufacturer declares at its own responsibility exclusively that the product fulfils basic requirements stated in Annex 1 of Regulations of the Czech Government No. 336/2004 Coll. (93/42/EEC) in the relevant valid readings. For the review were used these harmonised standards in a valid reading: EN ISO EN EN EN The examination of the conformity was carried out in participation of the Authoritative person Notified Body No The Manufacturer issued a Declaration of Conformity on this matter. SMT BM VET 18

19 8. ELECTROSURGICAL UNIT AND SUPPLIED ACCESSORIES Picture Control unit 1a - Operating Instructions 1b - Unit service special key to be used only by a licensed electrician to open enclosure in order to replace fuses if necessary. See section 6.3 troubleshooting and repairs. 1c - 3 Spare fuses: T4L250; T500L250; T3.15L250 (for 230V) 8.1. The basic accessory: 2- Applicator (hand-piece) 3- Neutral electrode (stainless steel) 4- Foot-operated switch (pneumatic) 5- Power cord 220/230/240V (110/120 V) 6- Set of active operating electrodes (6 various pieces) 8.2. Optional accessories: - Various coagulation and resection electrodes - Applicator for micro-coagulation (with connection cord) - Various micro-coagulation needles - Tweezers, peans for bipolar application - Connection cord for tweezers, peans for bipolar application 19 SMT BM VET

20 9. LIMITED WARRANTY The manufacturer guarantees the main control unit to be free from defects in material and workmanship for a period of two years from the date of purchase, except as noted below. The manufacturer guarantees the applicator holder, neutral electrode, the foot-operated switch to be free from defects in material and workmanship for a period of 6 months from the date of purchase, except as noted below. This manufacturer s warranty does not cover damage caused by misuse or abuse, accidents, the attachment of any unauthorized accessory, alteration to the product or any other condition whatsoever that are beyond the control of the manufacturer. The manufacturer or distributor will not be liable for any type of incidental, consequential or special damages. All implied warranties including but not limited to those of implied warranties of fitness and merchantability are limited in total duration of two years from the original date of purchase. To obtain warranty service on your SMT BM VET mail your unit and your dated sales receipts, postpaid, along with a check or money order to cover cost of return shipping of your choice to the manufacturer authorized service center address listed below. To obtain waranty call the Distribution and Service Center first to receive RMA number (Return Marchandise Autorization Number). Upon receipt the manufacturer authorized service center will repair or replace, as appropriate, your SMT BM VET unit and return it to you, postpaid. Service of this product by anyone other than the manufacturer authorized service voids warranty. This warranty provides you with special legal rights. You may have additional rights which may vary from state to state. Because of individual state regulations, some of the above limitations and exclusions may not apply to you. SMT BM VET 20

21 INDEMNITY AGREEMENT Product: RADIOFREQUENCY ELECTROSURGERY UNIT Type: SMT BM VET 120, 140, 180 Serial number: Date of sale: Stamp and signature of expedition: Guarantee Conditions: a) At observing Operating Instructions the manufacturer guarantees that the product shall have characteristics assessed by the relevant technical conditions and standards for the duration of 24 months from the date of sale. b) In case of failure in function of the product, not caused by the end user or by an inevitable event within the guarantee period, the product will be repaired free of charge. c) The free of charge repair within the guarantee period will be done after the presentation of the Indemnity Agreement by an accredited service or by manufacturer, whose address is in heading. d) The guarantee period shall be extended for a term of the guarantee repair. e) The Indemnity Agreement is at the same time The Certificate of the Quality and Completeness of the Product. To obtain waranty call the Distribution and Service Center first to receive RMA number (Return Marchandise Autorization Number).

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23 END USER REGISTRATION CARD PRODUCT: RADIOFREQUENCY ELECTROSURGERY UNIT TYPE: SMT BM VET 120, 140, 180 Serial number: User: Name: Company: Street Address: City: State: Phone: Zip: Fax: Purchase Date: Thank you for purchasing SMT BM VET. Please, fill in the required information and mail, or fax this card to us. Fax: smt-praha@smt-praha.com; straus@smt-praha.com Address: Special Medical Technology, Ltd, Papírenská 114/5, Prague 6, Czech Republic, EUROPE The objective of this registration is to improve the quality of services our firm offers to its customers and to observe strict requirements of standards EEC 93/42, ISO 9001 and EN our firm conforms and the user of medical technology must be acquainted with.

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26 Specialni Medicinska Technologie, s.r.o. /Special Medical Technology, Ltd./ Papírenská 114 / Praha 6, Czech Republic, EU Tel.: Fax: obchod@smt-praha.com N The last revision and issue of this Operating Instructions : 10/15/2012