In the name of God OPERATING INSTRUCTIONS Meg1 (with Ligasmart) Electrosurgical Generator Certifications: Thired Edition
Electrosurgical Generator Made in IRAN Printed in IRAN Date of issue: JULY 2013 KAVANDISH SYSTEM ENGINEERING Co. Pardis Technology park, Damavand Rd. 25 th Km.Tehran, Iran. Sales Office: Tel: (+98-21) 88259599 Fax: (+98-21)8824 3986 اinfo@kavandish.com E-mail: اwww.kavandish.com Http: Authorized representative in Europe: ELEKTROCOM ATTA. Kaiserstr. 27 a 44135 Dortmund. Germany E.mail : aelektro@yahoo.de Tel.:02 31-5864211,51 17 51 Fax : 02 31-5864210,59 52 07
CONTENTS CHAPTER 1 General Warnings and Cautions 1-1) To User 2 1-2) General Warnings 3 1-3) Neutral Electrode 8 1-4) The Procedures Minimize Adherence Effect in Bipolar technique 10 1-5) Electromagnetic Interference 12 CHAPTER 2 Controls and Symbols 2-1) Front Panel Operating Controls 14 2-2) Rear Panel Operating Controls 23 2-3) The Explanation of Symbol Printed in Front and Rear Panel 24 CHAPTER 3 Important Remarks on the Operation Of Electrosurgical Unit MEG1 3-1) Installation & Operating Instructions 26 3-2) Introduction and operation of LCD display pages 30 3-2-1) Utilization of LCD setting pages 32 3-2-1-1) Selecting programs; General surgery, Micro surgery, TUR 32 3-2-1-2) Adjusting time delay of Bipolar coagulation auto-start 35 3-2-2) Utilizing programmable memory 36 3-2-2-1) Recalling saved program in the memory 37 3-2-2-2) Saving surgeon s desired program 38 3-2-2-2-1) Defining a name for a program 39 3-2-3) Observation errors code which are manifested in the case of any damage or defect in the system 40 3-2-4) Table of warnings and messages which have been monitored by phrases 40 3-2-5) Table of warning concepts which have been saved by codes 43 3-3) Cleaning and Disinfecting of the Unit 44 3-4) Routine Maintenance and Inspections 44 CHAPTER 4 Recommendations for Power Setting in Monopolar & Bipolar Surgery 4) Output Power Setting 46 4-1) Output Power Setting in Monopolar Cutting 46 4-2) Output Power Setting in Monopolar Coagulation 47 4-3) Output Power Setting in Bipolar Coagulation 48 4-4) Output Power Setting in Bipolar Cutting 48 4-5) Output Power Setting in LigaSmart 48
CONTENTS CHAPTER 5 Accessories 5-1) The Accessories of Unit 50 A) Monopolar Handle 51 B) Monopolar Electrode 53 C) Neutral Electrode 54 A significant point about dual pad patient plate 55 D) Footswitch 56 E) Bipolar accessories 58 F) Bipolar Cutting 59 CHAPTER 6 Technical Characteristics 6-1)Technical Specifications 61 6-2) Maximum output voltage graphs of MEG1 68 6-3) Typical output Power graphs of MEG1 71 CHAPTER 7 Post-Sales Support and Warranty 7-1) Post-Sales Support 75 7-2) Warranty 75
CHAPTER 1 General Warnings and Cautions 1
Kavandish System Eng. Co. 1-1) To User This operation manual is intended to serve as an aid in the proper setup, installation and operation of the unit. The additional technical information is available in the service manual. All essential details of the equipment and all action required on your part are clearly presented and explained. Only qualified physician should be use this equipment. Please carefully study this manual and keep on hand for quick reference. 2
MATIN Meg1 Instruction Manual 1-2) General Warnings This instrument is not intended for use in areas subjected to explosion hazards because may arise ignition of flammable media. The unit can interfere with operation of surrounding electronic equipment. Please always clean and disinfect the unit with incombustible substances, otherwise let vaporize the applied flammable substances before operation. Never use needle electrodes for monitoring and if you are obliged to use them, separate their cables from HF cables of electrosurgical unit. Monitoring equipment, stimulating or taking photography probes may leak HF current and cause accidental burn so isolate them from neutral electrode or surgical electrode as far as possible. Observe 15-centimeter between active electrode and ECG electrode when they are in use with HF unit simultaneously. If electrosurgical method used on patient having cardiac pacemaker or any other electronic devices, may lead to irreparable damage or electromagnetic interference with their operation so consult a cardiologist and take sufficient care before operation. Use monitoring system and keep on hand defibrillator. The flammable liquid may accumulate under patient or body cavities such as navel, vagina or bowel so before the operation remove liquid from these areas. Put connecting cable of electrode in such a manner to avoid any contact with patient or any conductor In order to reduce the accidental burn hazards. Place the outputs, patient plate, monopolar electrode and bipolar forceps in such a manner do not come into contact with the patient and each others inadvertently. Isolate the active electrode are not in use now from patient s body. 3
Kavandish System Eng. Co. If you operate on the head and chest area, don t utilize flammable anesthetic substances or oxidizing agents (such as Nitrous Oxide N20 or Oxygen) unless be sucked them out of the body. The patient s body must not be allowed to come into contact with nearby electrically conductive objects (e.g. operating table, metal objects and wet towel). Since contact areas will generally be small in such cases, burn could arise from excessive current densities. It is recommended to utilize antistatic sheet (covering) Since elastic surface on operating table has a little electrical conduction are not suitable for isolation of patient from metal objects, thick dry electrically insulating pad thus be inserted between patient and the operating table and under any objects in use. Use absorbent towel to prevent the accumulation of liquid under patient. Figure1: Positioning of patient on the OR table Use monitoring system is equipped with HF current limit objects. Some material like cotton string and gauze when they are saturated with Oxygen may ignite from the sparking of the unit in ordinary use. In case you think that the output power rate is less than general situation, you may consider following items before increasing the output power of the unit. 4
MATIN Meg1 Instruction Manual Utilize merely accessories which are compatible with unit and never use damaged or defective accessories. Always check them and get confident of the accuracy of their insulation. Notice that at the time of activating output of the unit, it can electronically interfere with operation of surrounding electronic equipments. Never connect simultaneously two surgery pens to one output connector because two pens will be activate and inactivate simultaneously. Do not place connecting cables of monopolar pen and patient plate on the front panel as far as possible because it may causes Electromagnetic interference in the electric circuits of the unit. During some of surgery operation such as TUR, endoscopies, and laparoscopy utilize main output of monopolar 1 connector (page 15, Figure 4, connectors 44 and 45) because utilizing auxiliary output connector (page 15, Figure 4, auxiliary connector 46) may cause damage to monopolar 1. Notice that when two surgeons simultaneously activate monopolar 1 and monopolar 2 outputs in spray mode, the output power will be divided between two monopolar (1, 2) pens. Consequently connecting or disconnecting the current in one of monopolar pens, may effect on the output power of the next monopolar pen. Take whole specific precaution of electromagnetic compatibility and those which have been mentioned in section 1-5 of this manual. Portable and RF telecommunication equipments may interfere with the operation of Meg 1 electrosurgical generator electromagnetically. If any damage occurs in the unit, the output power rate may increases (in contrast with the selected level). Some factors, except increase of current density, may cause Necrosis. For instance during long lasting surgery operation such as cardiac surgery or neurosurgery, some tissue which are under pressure 5
Kavandish System Eng. Co. (such as buttocks and back of the head) will get necrosis. Even the patient s skin will get necrosis due to the pressure of fastening tightly plastic parts or bands to fix the patient plate. Sometimes long lasting contact of the tissue with chemical and allergen materials (such as disinfectants) will cause necrosis. In the case of observing early symptoms of necrosis (like unusual skin pale) take necessary measures to remedy injured parts. If you think output power no longer is optimal, check to be certain everything is in proper working order before increasing the power level. Is power level on panel properly set? Are desired conditions on the front panel properly set? Is neutral electrode in monopolar mode properly connected? Are cables and plugs firmly connected? Are active and neutral electrode cleaned? The unit should be operated with the compatible accessories (refer to chapter 5) and never apply defective and damaged accessories. All thermal instruments used in surgery produce smoke which potentially contains infective agents that may be hazardous to staff. Dedicated smoke evacuators must be used and the filters recommendations. High filtration face masks should be worn in all procedures that produce surgical plume to minimize the inhalation of carbonaceous particles. Warning: Patient can also suffer burns due to inadvertent activation of the HF generators due to occurring any direct or indirect contact between electrode and patient through dampened cloth or any conductive objects. 6
MATIN Meg1 Instruction Manual In fact unintended activation of the generators can occur as follows: If the footswitch or finger switch inadvertently depressed If there is a fault in one of the accessories cables If the unit is defective If the connection of footswitch or electrode to the unit causes an inadvertent activation, the defect arises from accessories. If the generators are activated without any connection of accessories to the unit, the unit will be defective. To prevent the accidental burn, never leave active electrodes in manners that could result in direct or indirect contact through the mediation of electrically conductive objects or damp cloth. If active electrode remains in constant contact when the generator will not be triggered, Endoscopy or TUR, pay more attention to the audible and optical signals due to activation of generators. In status do not need any generator activation for example, when you withdraw the electrode from the patient s body, certainly put output power displays in minimum level or switch off the unit. The active electrode can become very hot during cut and coagulation procedures, toughing or electrical sparking which could result in accidental burn when they come in contact with the other tissue. In the Bipolar technique, the HF current area is limited to the tips of instrument, and then burn hazards are reduced in comparison with monopolar technique because the output power is very low. 7
Kavandish System Eng. Co. 1-3) Neutral Electrode Warning: Always use the lowest output setting necessary in order to lessen the possibility of unintended burn injury. Kavandish recommends the use of Dual pad patient plate to maximize patient safety using a single pad patient plate will not activate the contact quality monitoring system. Accidental burns due to malfunction of neutral electrode can be reliably prevented if the safety instructions are observed: Carefully select the dimension and material of natural electrode according to figure 30 and level of output power. Put Neutral electrode in such a manner producing sufficient contact surface with the patient skin. It may cause burning If contact surface is small because the current densities enter the contact sites are very high. Figure 2: the reduction of effective site of neutral electrode Current conductive site The site in which doesn't conduct the current because it has no contacting with skin or has poor conducting due to the presence of grease, Oxidation, dirt and etc. Clean, massage and shave the patient s skin at contact areas to increase the conduction of skin where the neutral electrode is positioned. 8
MATIN Meg1 Instruction Manual The entire conductive neutral electrode surface should be firmly fastened to proper areas, upper arms or thighs positioned much nearer to the operational site to reduce the current s path between active monopolar electrode and neutral electrode. The current must never run across heart or lungs. Figure 3: The proper area for fastening the neutral electrode. Do not position neutral electrode on hypodermic large blood vessel. Securely fasten neutral electrode by using band in order to maintain contact over the full surface of the internal electrode. Check slippage of the neutral electrode if the patient is repositioned. A dry towel or gauze should be placed between skins to prevent skin areas touching each other for example, between arms and patient s body and between thighs. Always wipe the area in which sweats profusely and the parts may be in contact with the other parts. A dry patient plate or pad must only be used without gel if there is absolute certainty that the contact area between patient and 9
Kavandish System Eng. Co. plate electrode cannot become wet at any time during the entire operation, (as a result of perspiration, rinsing fluid, disinfectants, blood, etc.) Never use water or saline solution as a contact fluid for attaching patient plate. If Electrosurgery is performed on patient with a metal implant, place the patient plate in such a way that the currents do not pass through the implant. 1-4) The Procedures Minimize Adherence Effect in Bipolar technique: The bipolar technique offers the following benefits compared to the monopolar technique: 10 1. The applied HF current is smaller. 2. No neutral electrode is used. 3. HF current flows between both identical tips electrode. 4. Hazards of unintentionally burning patient are negligibly small. 5. prevents form unpredictable and unwanted coagulation. 6. Possibility of the electromagnetic interference with other electronic is drastically low. Therefore, the bipolar operative technique should be preferred whenever it can be used. In bipolar technique, one or more of the following complications could arise: Sticking tissues and clots to the tips of forceps sometimes caused to reopen the blood vessels when the forceps are withdrawn so the instrument should be kept clean at all times. Setting the output power more than you need or remaining the forceps on tissues at long time could be result in carbonizing the tissues and lead to adhesion of the tissue.
MATIN Meg1 Instruction Manual On the other hand, if the unit is activated before keeping electrode in contact with tissue, the initial sparking between electrode and tissue will cause either to carbonize the tissue or to adhere the tissue to the electrode. As far as possible, keep electrode in contact with tissue before activating of bipolar generator. For this purpose, the unit is equipped with a programmable timer adjustable from 0 to 2.5 seconds to permit precise control of power delivery. You can select time delay or no delay. In this system impedance between two electrodes is constantly detected. Whenever the tissue is positioned between two poles, the system will automatically be activated after a time delay adjustable from 0 to 2.5 seconds. Switch off the HF-current as soon as sufficient coagulation has been formed. Do not continue coagulation does not have any intended surgical effect. Always keep electrode clean and completely remove the tissue residues from electrode. Moisten the dry tissue to be coagulated with sterile water or with corporeal salt solution. If the tissue is adhered to the electrode during bipolar operation, switch off the HF current and withdraw the electrode then wait a minute to reduce the adherence through capillaries and adjacent tissues secretion. To coagulate the tissue keep electrode in contact with the tissue for a brief period after the HF current is switched off. In fact, fluid flows from capillaries and adjacent tissues will soften and dissolve adhering matter at the contact surface. Use sterile water or corporeal salt solution in such intensive cases. Always clean the electrode after every use because the tissues fluids cover the electrode surface. Remaining such fluids on 11
Kavandish System Eng. Co. electrode conduct the current slightly so the surgeon thinks that output power is low. 1-5) Electromagnetic Interference Warning: Interference produced by the HF surgical equipment may adversely influence the operation of adjacent electronic instruments. If you see abnormal situation in the adjacent equipment, note that it can be because of the action of the HF surgical equipment. If you realize that the interference only occurs when the generator is active, use following guidelines to reduce interference: 1- Use the lowest appropriate power setting 2- Use low-voltage modes such as PURE CUT or SOFT COAG or SWIFT COAG instead of high-voltage modes such as BLEND or SPRAY COAG. 3- Use bipolar technique instead of monopolar. 4- Keep the electrosurgical equipment and active accessories away from the susceptible equipment. For patients with cardiac pacemakers or other active implants, interference may occur, and even they can be damaged. When use of electrosurgical equipment is urgent in patients with cardiac pacemakers, use following guidelines to reduce the risk : 1- Use only Bipolar technique, if possible. 2- Check carefully the electrosurgical cables, instrument connections and patient return electrode contact to prevent possible sparking from a poor contact. 3- Place the patient return electrode close to the surgical site in such a way that the currents in the body do not pass through the heart area or pacemaker. 4- Ensure that there is good continuous ECG monitoring during the electrosurgical procedure. 5-Ensure that a defibrillator is in hand at all times. 12
MATIN Meg1 Instruction Manual CHAPTER 2 Controls and Symbols 13
Kavandish System Eng. Co. 2-1) Front Panel Operating Controls 14 Figure 4: Front panel
MATIN Meg1 Instruction Manual 1. This pushbutton and indicator light selects pure cutting mode. Un-modulated HF current at high power but due to relatively low voltage the destruction of the adjacent tissues is minimized. 2. This pushbutton and indicator light selects Blend I. Slightly modulated HF current so more coagulated occurs in comparison with pure cutting. 3. This pushbutton and indicator light selects Blend II. Medium-modulated HF current so the adjacent tissues are coagulation more intensely than Blend I. 4. This pushbutton and indicator light selects Blend III. Strongly modulated HF current so the adjacent tissues are coagulated more than the others. It is particularly well suited to incise tissues that are bleeding profusely. 5.This pushbutton increases the monopolar power output (Monopolar1,2) in cut mode. 6.This pushbutton decreases the monopolar power output (Monopolar1,2) in cut mode. If you press buttons 6 and 5 one time or hold your finger on them, you will observe changes of the level on digital display 39. These changes are applied in the form of separate steps in order that selecting the levels can be fulfilled more accurately. Notice that from 1 to 50 levels, the rate of level will change step by step, from 50 to 102 levels it will change two steps by two steps, from 105 to 200 it will change five steps by five steps and from 200 to the maximum level the changes will be ten steps by ten steps. It should be mentioned that chosen level is proportionate to the output power. The rate of level may be selected from the range of 1 level to nominal power in every monopolar mode. 7. This pushbutton and indicator light selects TUR mode. This mode is intended to be used for surgery in the fluid environment for instance urinary and prostate surgeries 15
Kavandish System Eng. Co. 8. This pushbutton and indicator light selects swift coagulation mode. This mode is well suited for quick coagulation of tissues by utilizing electrodes with a large diameter such as ball, plate electrodes or forceps. 9. This pushbutton and indicator light selects forced coagulation. This mode is well suited for deep coagulation of tissues by utilizing electrodes with a small diameter. The maximum output power is less than the previous mode but it is modulated more intensely. It is useful for electrode with thin diameter or doing deep coagulation. 10. This pushbutton and indicator light selects spray coagulation or fulguration. The crest factor of waveform is more than the others. It is suited for superficial coagulation and producing the electrical arc between the electrode and the tissue. You should use this mode to minimize incision effects or rupture of tissues. NOTE: In case of selecting spray mode, it is possible to activate both monopolar 1 and monopolar 2 output simultaneously, whereas we are not permitted to activate both of them in the other modes. In case of any demand to activate both monopolar (1, 2) output, the priority will be given to monopolar 1 and the second one will not have an output at that time. 11. This pushbutton and indicator light selects soft coagulation mode. It is intended to apply this mode for soft coagulation without suffering from carbonizing the tissue and adhesion of the tissue to the electrode. The rate of output power in the soft coagulation mode is less than the output power of three previous modes. 16
MATIN Meg1 Instruction Manual 12. This pushbutton increases the monopolar output power in coagulation mode. 13. This pushbutton decreases monopolar output power in coagulation mode. If you press buttons 12 and 13 or hold your finger on them, you will observe changes of the level on digital display 36. These changes are achieved in the form of separate steps in order that selecting the levels can be fulfilled more accurately. Notice that from 1 to 50 levels, the rate of level will change step by step, from 50 to 102 levels it will change two steps by two steps, from 105 to 200 levels it will change five steps by five steps and from 200 to the maximum level the changes will be ten steps by ten steps. It should be mentioned that chosen level is proportionate to the output power. The rate of level can be selected from the range of 1 level to the nominal power in every monopolar mode. It should be mentioned that if you press the button and hold it more than 1 second continuously in this mode, the speed of changing the level will increase to make the adjustment easier. 14. This pushbutton and indicator light select Auto Stop mode for monopolar coagulation. If you want to stop coagulation at the time of optimum coagulation automatically in soft coag mode, you can choose Auto Stop mode. Consequently the equipment will measure electric resistance changes of the tissue which is under coagulation. When the tissue reaches to the optimum coagulation stage (before carbonizing and desiccation of the tissue), the output will be terminated automatically and related audible alarm will be sounded. Notice that you can choose this mode (Auto Stop) only in the soft mode and there will be no reaction if you press this button when you are in other modes. 17
Kavandish System Eng. Co. 15. This indicator light switches pedal footswitch to monopolar mode. 16. This pushbutton switches footswitch to bipolar or monopolar generator. A single press of the button 16 changes the position of lights 15, 17. Pressing the pedal in monopolar mode, activates monopolar output. This has no effect on bipolar output. When you press the pedal in the Bipolar mode, situation is exactly reversed. 17. This indicator light selects bipolar mode for pedal footswitch. 18. This pushbutton and indicator light selects auto-start mode with programmable delay. if footswitch has been selected for Bipolar, The Auto Start mode Will Change to manual mode by pressing the footswitch. Auto Start Bipolar coagulation: The bipolar output is activated after the two tips of forceps touch the tissue. It is impossible to activate the bipolar output automatically whenever monopolar output is activated. 19. This pushbutton and indicator light selects LigaSmart mode. This mode is intended to be used for permanent coagulation tissue bundles with large areas. 20. This indicator light selects manual Bipolar Coagulation. Bipolar output is activated only by pressing footswitch. 21. This indicator light selects manual Bipolar Cutting. Bipolar output is activated only by pressing footswitch. 22. This pushbutton and indicator light selects Auto Stop mode for Bipolar coagulation. If you want to stop coagulation at the time of optimum coagulation automatically in Bipolar Coag mode, you can choose Auto Stop mode (the other explanations is similar to part 14). Moreover you should 18
MATIN Meg1 Instruction Manual notice that Auto Stop mode is always activate in Liga smart mode and is always inactive in Bipolar cut mode, so pressing this button in this mode, do not make anything activate. 23. This pushbutton decreases Bipolar output power. If you press buttons 23 and 24 one time or hold your finger on them, you will observe changes of the level on digital display 33. These changes are achieved in the form of separate steps in order that selecting the levels can be fulfilled more accurately. Notice that from 0.1 to 1.0 level, the rate of level will change 0.1 step by 0.1 step, from 1.0 to 5.0 level it will change 0.2 by 0.2 step, from 5 to 10 level it will change 0.5 by 0.5 steps, from 10 to 20 level it will change step by step and from 20 to 100 level the changes will be two steps by two steps. Also the rate of chosen level is almost equal to output power and can be selected from the range of 0.1 w to nominal power. 24. This pushbutton increases the Bipolar output power. 25. This pushbutton selects a mode in order to return to the previous page in LCD display (LCD adjustment). 26. This pushbutton selects the mode to move LCD display downwards to select desired options. 27. This pushbutton selects the mode to move LCD display upwards to select desired options. 28. This pushbutton selects and confirms the continuation of the operation or operation path; in the LCD display (complete explanation about various menus of LCD will be notified in chapter 4, under the title of Introduction of LCD display pages ). 29. This pushbutton places the equipment in the standby mode. In 19
Kavandish System Eng. Co. order to activate standby mode, you should press this button and hold your finger on it 1 to 2 seconds. In this case the equipment will not run any command. Notice that whenever you exit from this mode, the unit will turn on and operate commands. In order to exit from the standby mode, press the button again and hold it 1 to 2 seconds (when the equipment is in the standby mode, all of previous saved data will be reserved in the unit memory and as soon as the unit exits from this mode, all of saved data will be displayed. However, electric current interruption will disappear all of the saved data). 30. This indicator light informs you that an error has been occurred because of an internal damage, operator mistake, or plate connection problem.(refer to chapter 3 for more details) 31. LCD display which is used to display and adjust modes, memories, and messages. 32. This indicator light indicates the activation of Bipolar coagulation generator. 33. This digital display indicates the Bipolar output power. 34. This indicator light indicates the activation of Bipolar cutting. 35, 37. These indicator lights indicate the activation of monopolar coagulation generator. 36. This digital display indicates monopolar output power in coagulation mode. 38, 40. These indicator lights indicate the activation of monopolar cut generator. 39. This digital display indicates the monopolar power output in cut mode. 20
MATIN Meg1 Instruction Manual 41. This indicator light indicates the connection of Dual Pad plate to the unit and indicates that the contact quality of plate with patient is acceptable. 42. Connection place of single and dual pad patient plate to the unit. 43. This indicator light indicates the connection of Single Pad plate to the unit. 44. Connection place of monopolar pen to the unit. The connector diameter is 8 mm. There is no need to any adaptor because this connector is planned for the equipments such as Endoscopy, Laparoscopy or TUR units which are compatible with 8 mm diameter standard. In case that these units have been manufactured according to 4mm diameter standard, you may utilize next connector (45). In this case the unit will be activated only by footswitch. Warning: When you are utilizing this connector as an output, all of monopolar1 output terminals have voltage too, so take sufficient care before operation. Moreover, when monopolar 1 output is activating, the monopolar pen which is connected to this connector also have voltage. Therefore apply necessary precautionary actions and never connect two cautery pens to the monopolar 1 connectors simultaneously. 45. Connection place of martin type monopolar connector (Mono1) to the unit (Complied with Martin and Berchtold model) and also connector of Endoscopy, laparoscopy, and TUR units which are compatible with 4mm diameter standard 46. Auxiliary terminals, only for connection of 3-pin Handel to monopolar1 output. 21
Kavandish System Eng. Co. Notice: These terminals are used only with 3-pin hand switching accessories. Connecting one-pin foot switching accessories to these terminals may result in product damage. Use only the 44 and 45 output receptacle for TUR or Endoscopy or Laparoscopy. 47. Connection place of martin type monopolar connector (Mono2) to the unit (complied with Martin and Berchtold model). The unit is equipped with Monopolar 2 output so that two surgeons operate on a patient simultaneously while utilizing two separate pens, for instance during coronary artery transplantation surgery, utilizing two separate monopolar pens is unavoidable. It should be mentioned that monopolar2 output is activated only through finger switch and does not activate by footswitch. 48. These Auxiliary terminals, only for connection of 3-pin to monopolar2 output. 49, 52. Connection place of LigaSmart pen. 50. Bipolar forceps jack (for Martin&Berchtold Standard). 49,51 and 49,52. Connection place of Bipolar pen complied with valleylab and 4mm standard connector. 53. This pushbutton and indicator light indicates the activation of Liga Smart mode. 54. This indicator light indicates the activation of bipolar generator. 55. This indicator light indicates the activation of monopolar2 output. 56. This indicator light indicates the activation of monopolar1 output. 57. This warning indicator light is related to patient plate. Whenever the patient plate disconnects from the unit, or a problem occurs along the plate connection path which causes the impedance discrepancy between two tips of connection path increased more than 150 ohms, this warning light will flash. 22
2-2) Rear Panel Operating Controls MATIN Meg1 Instruction Manual Figure 5 : Rear panel 58. Line cord receptacle (200 240(VAC), 50Hz) and Input Fuse (5A/250V/S) place. 59. Main power switch. 60. Manufacturer s identification label. 61. Audio volume dial. Rotate the dial clockwise to increase volume and vice versa. The dial just affect on volume that is sounded during activating the generator. It does not have any effect on the alarming sound of neutral electrode. 62. Pedal footswitch receptacle. 63. A warning sign which indicates possibility of electric shock due to direct contact with steel parts of connectors or internal circuits of the unit because high voltage exists in these parts. 23
Kavandish System Eng. Co. 2-3) The Explanation of Symbol Printed in Front and Rear Panel Neutral electrode and the other applied parts such as monopolar outputs and Bipolar output are isolated from earth and electrical supply outlet at both high and low frequency. Connection place of single and dual pad patient plate. The degree of protection against electric shock is CF type and LF leakage current is very low and is protected against high voltage due to defibrillator. The output connectors are marked with this sign can be activated by hand switching. The output connectors are marked with these signs can be activated by foot switching. The outputs are marked with this sign may be activated automatically after the electrode has come into contact with the tissue. Study the instruction manual before operating the equipment. Hazard of high voltage in the output connectors Output connector suited for TUR surgery operation. Study the instruction manual Warning Electrostatic discharge Manufacturer Authorized representative in the European Community Unit serial number A warning sign which indicates the probable unit interference with operation of surrounding electronic units. 24
MATIN Meg1 Instruction Manual CHAPTER 3 Important Remarks on the Operation of Electrosurgical Unit Meg1 25
Kavandish System Eng. Co. 3-1) Installation and Operating Instructions Remove all packing materials. Thoroughly check all accessories and any appearance items of the product for probable damages. In the case of any damage(s) due to shipping or any other reason, please notify defects or damages to kavandish system engineering company and send your address with the serial number of the unit. Connect the power supply cord into an electric outlet. Notice that the power- supply source should be 220V + 10%. Then turn on the equipment with the main power switch (59), located at the unit rear panel. The front panel should switch on and then the system starts to operate self-checking process. This process begins with checking LCD display and 7-segment displays by turning them on. Then mono-cut, mono-coag and Bipolar modes will be checked and their related indicator lights will be turned on. At the end of self-checking process, in case of detecting technical problem, this message should appear on the LCD display (Figure 6). SELF CHECK REPORT ERROR COAD ARE : 02,12,22 Figure 6 In case the reported errors were not under your consideration (in your select mode), you would press any key to activate the system (explanation about error codes is prepared in pages 42 to 44). It should be mentioned that activation of those modes which are listed in the error report is not free of problem. 26
MATIN Meg1 Instruction Manual If self-checking process was achieved successfully and No error detected in the system, this message should appear on the LCD display (Figure 7): SELF CHECK REPORT NO errors report Figure 7 Then you will observe this message on the LCD display: Welcome to MEG1 (Figure 8). WELCOME TO MEG1 Please Press a Key To Start Figure 8 At this stage all data which have been saved in the memory 10 previously, will appear and flash on LCD display. Then you may press any key to choose normal mode and make the system ready to operate normally. If the plate is not connected to the unit, indicator light should flash continuously and plate audible warning should be sounded for a few seconds simultaneously and then audible alarm should be off. Then PT error report should appear and flash on the LCD display (If the monopolar generator activates in this position, audible and optical warnings will start to fluctuate and simultaneously plate error message will appear on LCD display continuously). 27
Kavandish System Eng. Co. If you are switching on the unit for the first time, you should conduct an operational check of the instrument before utilizing the unit in operating room. Perform checking process according to the following instructions: Self checking process should end up without any interruption. Finally select modes should appear on LCD display (Figure 9). It should be mentioned that at the beginning of the switching on process, all of data saved in the memory 10 should appear on LCD display and activate (the manufacturer company has set a program as a default in this memory previously). All digital displays 33, 36, 39 should respectively indicate the power rates which have been set in the memory 10 previously. Note: Appearing this position (( ---- )) on display, indicates that the rate of output power has not been selected. Connecting a flawless single pad neutral electrode to the unit, you should not sound any audible warning and the Plate Error message should not appear on LCD display and also indicator light 43 should be turned on to verify the accuracy of connecting the single pad plate to the patient s skin and unit. If a dual pad neutral electrode is connected to the unit and has produced sufficient contact surface with the patient's skin, you should not sound any audible warning and the Plate Error message should not appear on LCD display and also indicator light 41 should be turned on to verify the accuracy of connecting the dual pad plate connection to the unit. Check all accessories, monopolar pen, neutral electrode, pedal footswitch, and Bipolar pen connectors accurately. Connect them to the unit if they are in proper condition. In order to activate the unit generator, set the digital displays 33, 36, 39 by pressing their related pushbuttons, then set pedal footswitch to 28
MATIN Meg1 Instruction Manual monopolar mode. Place a piece of raw meat (or fruit or a bar of soap or a damp cloth) on a neutral electrode then press finger switches located on monopolar pen in order to activate cut and coagulation generator and then place monopolar pen against meat and finally activate HF output. Each time you activate cut generator, indicator lights 38 and 40 should light and a running sound should be audible. If you activate coagulation generator, indicator lights 35, 37 should light and a running bass voice with low frequency should be audible. The said procedure is exactly repeated if you depress the footswitch and then all data related to select mode, operation mode, manner of activating generator, and error report (If was detected) should appear on LCD display simultaneously. Press the pushbuttons 5 and 6 in cut mode and pushbuttons 12 and 13 in coagulation mode in order to observe changes of the level on digital displays of every mode. Also depress footswitch or finger switches to activate HF output. Then you should observe changes of the output power in cut and coagulation mode on raw meat. Set the digital display 33 by pressing pushbuttons 23, 24. Set the footswitch to Bipolar mode. Place Bipolar forceps against row meat and then activate the HF output by depressing the foot switch. Repeat the said procedure for both Bipolar cut and Bipolar coagulation mode. Whenever you activate Bipolar generator, indicator light 54 should light for Bipolar- Cut and Bipolar coagulation mode and indicator light 53 should light for Liga Smart mode and then a running sound related to the select mode should be audible. Press push button 18 to set Bipolar generator to Auto mode. Place two tips of forceps on a raw and wet meat. The Bipolar generator should be switched automatically and activate after a time delay of 0 to 2.5 second (depending on the select position by the LCD display). Now press pushbuttons 20 or 21 to set the Bipolar generator to Bipolar Coag or Bipolar cut or Liga Smart mode. In this position the generator should 29
Kavandish System Eng. Co. not become activate automatically after placing two tips of forceps on the raw meat. 9) Press pushbuttons 23 and 24 in Bipolar mode to observe the changes of the level on digital display 33. Place Bipolar output against raw meat and activate it by depressing footswitch or automatically in order to observe changes of the output power. Repeat the said procedure for Bipolar Cut, Bipolar coag, and LigaSmart modes. 10) Press pushbuttons 1 to 4 for selecting monopolar cut mode and pushbuttons 8 to 11 for selecting monopolar coag mode. Consequently, the names of select modes appear on LCD display. The operator shall notify any problem or defect or dissatisfaction related to the operation of the unit (after performing checking process) or packing or shipping the product or even recycling the product (at the end of its service life) and also any suggestion to improve product s quality, to Kavandish system company, department of post- sales services with the serial number and address. 3-2) Introduction and operation of LCD display pages: The Meg 1 unit is equipped with LCD display which is well suited for numerous functions. These functions are divided into two main parts: Part 1) the LCD display is exclusively allocated to display data and merely makes the operator familiar with the situation of the unit. For instance, when the generator is not activating, the LCD display should manifest main program of the system on the first line which includes one of these programs: TUR, Micro surgery, General surgery. The LCD will display select mode of monopolar cut on the second line which includes one of these 4 modes; pure, Blend 1, Blend 2, Blend 3. The LCD will display select mode of monopolar coagulation on the third line which includes one of these 4 modes: soft, spray, forced, swift. The warning messages will be displayed on the fourth line. A sample of this LCD page (the generator is inactive) was shown in the Figure 9. 30
MATIN Meg1 Instruction Manual General Surgery Cut: pure Monopolar select program Monapolar select mode Coag: swift Figure 9 Menu Go to main page When the generator is activate, the type of active output should be displayed on the first line of LCD which includes one of these eight modes: Monopolar coag1, monopolar coag 2, monopolar cut1, monopolar cut2, monopolar coag, Bipolar cut, Bipolar Liga, Bipolar coag. The effect mode should be displayed on the second line and the type of instruments and accessories (hand switch or footswitch) should be displayed on the third line. A sample of this page was shown in the Figure 10. In addition to the said displaying facilities, some parts of complementary adjustment and programming process would be achieved only through LCD display and through four parts pushbutton board which is located under the LCD. You would be familiar with the method of setting and programming the unit during the following stages. MONOPOLAR COAG 1 Effect: Swift Activation: Foot Sw Figure 10 31
Kavandish System Eng. Co. 3-2-1) Utilization of LCD setting pages: In order to go to the setting page, press Menu button to enter to the Main page then press Next button to enter to the setting page. In this page you profit from special facilities which will be explained in the next parts. List of available instruments to select the options: Back option to return to the previous display page downwards arrow upward arrow Next option to verify the selection and also to select the path continuation or to select the continuation of the operation in the display 3-2-1-1) Selecting programs; General surgery, Micro surgery, TUR General surgery: If you intend to operate with normal mode in monopolar (cut and coag) mode, you may select General surgery. In general position you should always select this mode. Micro surgery: This mode enables the surgeon to operate delicate surgery operation with low power and high accuracy. TUR: TUR mode is well suited for surgery operation under the fluid environment such as urinary and prostate surgery. To select TUR program, perform following steps respectively: Select Menu option (by pressing pushbutton 4) then go to the main page, as a result Figure 11 will be displayed. Select Setting option from the main page (by the upward and downwards arrow pushbuttons). 32
MATIN Meg1 Instruction Manual Setting Programming MAIN PAGE Back Next Figure 11 Select Next option (by pressing pushbutton 4) to do necessary setting. Then Figure 12 will be displayed. Mode : General Bip. Time : 00 SETTING Back Next Figure 12 Select Next option again. Then a page for selecting operating modes should be appeared (Figure 13) General Surgery MICRO Surgery TUR Back Set Figure 13 Select your intended operating mode (for example TUR mode) by downwards arrow pushbutton (Figure 14). 33
Kavandish System Eng. Co. General Surgery MICRO Surgery TUR Back Set Figure 14 Then select set pushbutton. Consequently Figure 15 appears for a few seconds which means your selection has been verified. Operating Mode Is Set On TUR Figure 15 At this stage the selection has been achieved completely. The select item (TUR option) should appear on LCD display, before the mode option, to make you assure of the selection process accuracy (Figure 16). Mode : TUR Bip. Time : 00 SETTING Back Next Figure 16 34
MATIN Meg1 Instruction Manual 3-2-1-2) Adjusting time delay of Bipolar coagulation automatic start: Bip. Time: You may use this option if you intend to achieve Bipolar coagulation with time delay and automatically, especially after touching the tissue. To adjust time delay (from 0 to 2.5 seconds) exactly perform following stages: Select Menu option to go to the main page. Select Setting option from the Main page then select Next option. Select Bip. Time option then select next to enter the Setting Page. Set the time by pressing INC (increase) pushbutton and Dec (decrease) pushbutton. For instance to set the time on 2 second you should press INC pushbutton two times (Figure 17). Auto Bip. DELAY t = 1.0 Sec Back Dec Inc Set Figure 17 Now select Set option. So this message will appear on the page for a few seconds (Figure 18). Auto Bipolar Delay time Is Set to 1.0 Sec Figure 18 35
Kavandish System Eng. Co. 3-2-2) Utilizing programmable memory: You are faced with two option in this mode; load and save. Load: This option enables the surgeon to recall and reuse his/her desired program which has been saved previously. Save: This option enables the surgeon to save a specific private program and allocate it to his/ her surgery operation. Consequently surgeon can recall and reuse the program for the next surgeries. Select Menu option from the display page to enter to the Main Page and have access to the memory. Select Programming options by pressing upward and downwards arrow pushbuttons (Figure 19) then select next to enter to the Programming page. Now Figure 20 appears on display. Setting s Programming MAIN PAGE Back Next Figure 19 Load Save PROGRAMING Back Next Figure 20 36
MATIN Meg1 Instruction Manual 3-2-2-1) Recalling saved program in the memory: To recall saved program, perform the following stages respectively. After entering to the Programming page, select Loading Program item then select Next to enter to the Recall Page (Figure 21). LOAD PAGE Program NO: 1 Name: HEART Back Load Figure 21 Select number of your desired program to recall it by pressing upward arrow pushbutton to increase the number and pressing downwards arrow pushbutton to decrease the number. Then select load option to recall the select memory. Then a message (Figure 22) appears on the display for a few seconds (corresponding to the number of the select program) PROGRAM NO : 1 MATIN Is being Loaded Figure 22 37
Kavandish System Eng. Co. 3-2-2-2) Saving surgeon s desired program To save your desired program, fulfill the following stages respectively. After entering to the Programming page, select Saving Program item by pressing upward and downwards arrow pushbuttons (Figure 23). Load Save PROGRAMING Back Next Figure 23 Select Next to enter to the program save page (Figure 24). SAVE PAGE Program NO: 1 Name: AAAAA Back Name Save Figure 24 NOTE: In this page, Name option is used to define a name for the saved program. At first select Name item to enter to the Programming page in order to define a name. Use upward arrow pushbutton to increase the number of the program after defining a name and number for the verified program, you may select save option to save the program. 38
MATIN Meg1 Instruction Manual At first surgeon should define a name and number for his / her desired program (According to the instruction which will be stated in the next part). Then surgeon should select his/her required modes and desired powers and finally should select save option to save all of select settings. As a result a message appears on the display which informs that all data have been saved (Figure 25). System Settings are being Saved into Program No.1 MATIN Figure 25 3-2-2-2-1) Defining a name for a program After entering the Save Page, select Name to enter the Name program (Figure 26). Using upward arrow pushbutton, you can select a character and change it. Then the select character starts to flash Program Name Program NO: 1 Name: AAAAA Back CHR Set Figure 26 CHR: The CHR option is used to select characters in order to name the program which is surgeon's desired program. (Upward arrow pushbutton): select CHR option to choose a Latin character. 39
Kavandish System Eng. Co. Then you can change the character by pressing upward arrow pushbutton until you find your intended character (first Latin character then numbers) To continue the process, select CHR again and continue this procedure until whole characters of the name were selected. Finally select set option. 3-2-3) Observation errors code which are manifested in the case of any damage or defect in the system: In order to observe errors code, follow these steps respectively: Select Menu option and then go to the Main page. Select Error option by pressing upward and downwards arrow pushbuttons in the Main page. Then select next and enter to the ERRORS page. When you enter this page, you can observe last produced errors in the system during the operation (Figure 27). It is necessary to mention that the errors which appear by this way are not consist of errors detected during self-checking process and only consist of errors which have been produced during operating the unit. ERRORS 62, A2 Figure 27 3-2-4) Table of warnings and messages which have been monitored by phrases: 40
Warning Fail : Plate Er : PT BA UNACCEPT ABLE REQUEST Er : IR Warning concept Disconnection of the plate from the unit or plate cable problem or lack of sufficient contact surface of dual pad plates with patient's skin at the time of commanding for the activation of monopolar generator. Disconnection of the plate from the unit or plate cable problem or lack of sufficient contact surface of dual pad plate with the patient's skin while being ready to activate without any demand to activate monopolar generator. Selecting Auto Bipolar Coagulation mode. Depressing simultaneously two monopolar pen finger switches or two pedal of footswitch. Existing previous command to activate the unit when the unit is in the standby or the self-checking mode. Reaction of the system System stops Just warning signals is produced and activation of monopolar generator is not possible. Just warning signals System stops Just warning signals is produced and the system will not run the command which has been released previously. MATIN Meg1 Instruction Manual 41
Warning Coag complete Fail : P=0 Fail : TO Fail : Time Out Fail : P>200 Fail : H.V Fail : FE Fail :LC Warnings concept Optimum coagulation point in Auto stop mode. The power rate is not selected in the intended mode. Generator remains activate more than 30 seconds. Generator remains activate more than 1 minute continuously. Generator remains activate more than 1 minute with the power more than 200 W and reactivates again while it has been shut off less than 1 minute. Occurring a problem in the internal power-supply source of the unit. Occurring a problem in the HF generator or reduction of the output from the permissible rate. An increase of leakage current over the permissible rate. Reaction of the system System stops System stops Just warning signals System stops System stops System stops and the error code is saved in the memory. The error code is saved in the memory. The error code is saved in the memory. Kavandish System Eng. Co. 42
code code MATIN Meg1 Instruction Manual 3-2-5) Table of warning concepts which have been saved by codes: Code concept Code concept 01 Damage in auto-bi-coag power-supply. 72 Damage in Blend 3-cut generator. 02 Damage in auto-bi-coag generator. 73 Impermissible leakage current in Blend 3-cut. 11 Damage in bi-manual power-supply. 81 Damage in swift-coag power-supply. 12 Damage in bi-manual generator. 82 Damage in swift-coag generator. 21 Damage in bi-cut power-supply. 83 Impermissible leakage current in swift-coag. 22 Damage in bi-cut generator. 91 Damage in forced-coag power-supply. 41 Damage in pure-cut power-supply. 92 Damage in forced-coag generator. 42 Damage in pure-cut generator. 93 Impermissible leakage current in forcedcoag. 43 Impermissible leakage current in pure-cut. A1 Damage in spray-coag power-supply. 51 Damage in Blend 1-cut power-supply. A2 Damage in spray-coag generator. 52 Damage in Blend 1-cut generator. A3 Impermissible leakage current in spray-coag. 53 Impermissible leakage current in Blend 1-cut. B1 Damage in soft-coag power-supply. 61 Damage in Blend 2-cut power-supply. B2 Damage in soft-coag generator. 62 Damage in Blend 2-cut generator. B3 Impermissible leakage current in soft-coag. 63 Impermissible leakage current in Blend 2-cut. F4 Damage of monitoring circuit of patient plate. 71 Damage in Blend 3-cut power-supply. F5 Damage of system memory. 43
Kavandish System Eng. Co. 3-3) Cleaning and Disinfecting of the Unit Install the unit in proper site to avoid any damage to the unit. This unit is not intended to use in areas subject to explosive substance hazards and infected liquid. The instrument s surface should be cleaned and disinfected with incombustible substances. Do not allow any liquid enter the unit. Do not use flammable or explosive liquids. If you have to clean and disinfect the unit with them, make certain that all combustible substances have been vaporized from the operating room. Withdraw or insert the accessories plugs smoothly to increase the service life of them. NOTICE Penetration of liquids into the device can cause damage to it; since there is the possibility of liquids penetration from its bottom side, observe necessary precautions during cleaning and disinfecting the device. 3-4) Routine Maintenance and Inspections Deliver the equipment every 3-year to the Kavandish Company or any authorized agent of this company to inspect the unit thoroughly and receive again qualitative control results and safety standard test card of the unit. 44
MATIN Meg1 Instruction Manual CHAPTER 4 Recommendations for Power Setting in Monopolar and Bipolar Surgery 45
Kavandish System Eng. Co. 4) Output Power Setting Warning: Remember that, selecting power rate more than the required rate can cause an increase of probable dangers and side effects. 4-1) Output Power Setting in Monopolar Cutting The optimal output power setting is that yields the best result in the desired cutting effects. The best power level depends on the following factors: What shape does the electrode have? How fast does the surgeon s hand go? How does the electrode move on the tissue? What structure does tissue? What shape does the current wave have? The power setting completely depends on experience and opinion of surgeon but the following further provisions in selecting the optimum output power is as follows: Set power at 100 to 150Watt in pure cut mode, when using needle or lancet electrode with too small diameter that are useful in smooth cutting with minimum adjacent surface coagulation. Set power level at 150 to 200Watt in pure cut mode, when using the electrode with larger diameter, ball and blade electrode. Set power level for more coagulation in adjacent tissue as follows: Set power level at 120 to 170Watt in Blend1 mode. Set power level at 100 to 150Watt in Blend2 mode. Set power level at 50 to 100Watt in Blend3 mode. Increase power 20 to 50Watt in cutting the greasy tissue because the electric resistance increases in such tissues. Always keep the electrode clean that could lead to high equality in cutting 46
MATIN Meg1 Instruction Manual and prevent to increase the power setting more than necessary. If you need to utilize TUR mode you will be permitted to use all various modes of Blend and pure mode.generally suitable power in pure mode is between 150 to 200 Watt, in Blend 1 mode is between 120 to 170 Watt, in Blend 2 mode is between 100 to 150 Watt, and in Blend 3 mode is between 70 to 120 Watt. 4-2) Output power setting in monopolar coagulation The proper setting level depends on tissue type, electrode shape and current waveform. Therefore, observe the following procedure to see the optimum power output: Always keep the active electrodes clean otherwise accidental sparking and carbonization of tissues may occur. It is recommended that swift coagulation utilize and 50 to 100Watt output power set when ball, plate electrode or forceps is utilized. Utilize forced coagulation and set output power between 30 to 70Watt in the event of choosing the active electrodes their efficient surface is relatively small. Set output power between 20 to 50Watt in spray coagulation mode if you use the electrode with thin diameter. Select the soft coagulation to minimize tissue carbonization. Mostly suitable power in this mode is between 40 to 80Watt. 47
Kavandish System Eng. Co. 4-3) Output power setting in bipolar coagulation Mostly suitable power in this technique is between 25 to 50Watt. Setting too high power result in adhering electrode to the tissue would certainly produce superficial carbonization, so the current is not delivered. If you clean the tips of forceps and set the optimum power, complete coagulation will form during 1 to 5 seconds. Setting the power too high can lead to increase the vapor pressure within tissue originating from sharp rises in temperature that are sufficient to produce sudden rupture or explosion of tissue. However, setting the power too low can be subjected to forming coagulation very slowly. 4-4) Output power setting in bipolar cutting In the case of utilizing this mode it is recommended to set output power rate from 50 to 100 Watt. 4-5) Output power setting in LigaSmart It is recommended to set the output power rate from 100 to 160 Watt which is ideal for surgery operation. When utilizing this mode, at first set the output power then place desired tissue between two poles and then activate HF generator by depressing pedal footswitch. After activating the generator if the desired tissue has reached to the optimum coagulation point, the unit would deactive the HF generator automatically. Then related audible and optical warnings should be switch off and coag complete message should appear on LCD display and just a discontinuous audible warning should be sounded. If the tissue dose not response to the HF power or the rate of tissue impedance is not in permissible range, the HF power should disconnect after a few seconds and finally Regrasp error warning should be observed. 48
MATIN Meg1 Instruction Manual CHAPTER 5 Accessories 49
Kavandish System Eng. Co. 5-1) The Accessories of Unit The accessories of electrosurgical unit MATIN Meg1 are as following: 1. The monopolar electrode handle. 2. Active electrode for cutting and coagulation. 3. Neutral electrode with connecting cable. 4. footswitch 5. Bipolar forceps with connecting cables. Warning: Use only original accessories recommended by kavandish. In case of doubt ask the kavandish or its representative to certify compatibility. Utilizing non-standard or defective accessories or using accessories other than those allowed by Kavandish may cause following consequences: - Inadvertent generator activation. - Injury or electrical shock to the patient or surgical team. - Deactivation of contact quality monitoring system (REM). - Unintended surgical effects. - Low or intermittent ESU power output. - Abnormal neuromuscular stimulation because of metal-to-metal arcing or sparking. - Monitor interference when ESU is activated. - Excessive HF current leakage. - Generator malfunctions. 50
MATIN Meg1 Instruction Manual Warning: Monopolar accessories are to be connected only to monopolar receptacles. Bipolar accessories are to be connected only to bipolar receptacles. All accessories must fit securely without forcing the accessory into the port. Do not use any accessory that does not connect properly, or that has cuts, nicks, or other visible signs of wear. Fix the connectors and plugs of accessories gently to the unit and don t put any extra pressure on cables and plugs. Warning: Don t use adaptors in order to connect accessories to generator. A) Monopolar Handle The monopolar receptacles accept following types of accessories: 1- Three-pin hand switching {Mono1 (45,46)}, {Mono2(47,48)}. 2- Two pin handswitching or foot control pencil with shrouded martin type plugs connector {Mono1(45)}, {Mono2(47)}. 3- One pin foot control pencil with ø 8mm plug connection {Mono1(44)}. 4- One pin foot control pencil with ø 4mm plug connection {Mono1(45)}. 51
Kavandish System Eng. Co. Figure 28 : Some types of compatible monopolar handle The unit is compatible only with following types of electrode handle: Bowa, Martin, Valleylab, Berchtold and Fiab. Electrodes, which are installed on these handles, are used as active electrode in monopolar surgery. Notice that monopolar pen and all cables should be properly insulated in order that they can tolerate output voltage of the unit (According to the graphs in the pages 68 to 70). To become confident of this issue, refer to the manual of monopolar pen. Warning: Insulation of instruments is more significant issue especially when utilizing those modes with high voltage such as spray mode. Notice that any damage or defect or feebleness in the insulation of cables and monopolar pen, especially when utilizing high voltage modes, may lead to an accidental burns and dangerous side effects. 52
MATIN Meg1 Instruction Manual B) Monopolar Electrode Figure 29 : Some types of monopolar active electrode There are various types of electrodes in different types and shapes that enable surgeon to operate. Ease of installing enables the surgeon to select the desire direction by rotating each electrode. The suitable type of electrode depends on the intended cutting or coagulation effect and selected modes. Needle or lancet electrodes with small diameter are suited for smooth cuts without surface coagulation. The use of loop electrodes is recommended for biopsy and other tissue-removal interventions. Ball or plate electrodes are used for contact coagulation. 53
Kavandish System Eng. Co. C) Neutral Electrode The neutral electrode receptacle accepts only cables with ø 6.3mm plug connection(42) and accepts both dual pad and single pad neutral electrode. Kavandish recommends only following types of patient plate for meg1: Bowa, Martin, Erbe, Fiab, Valleylab, Berchtold. Selecting the material and dimension of neutral electrode depend on the output power. The following figure indicates the minimum area of neutral electrode. Figure 30: The safe minimum surface area for various types of neutral electrode as a function of output power. A) Neutral electrode of conductive polymer. B) The neutral electrode of stainless steel sheet without use any electrical conducting gels. C) The neutral electrode of flexible metal layer uniformly coated with conducting gel. 54
MATIN Meg1 Instruction Manual In order to clean and disinfect the patient plate, exactly operate according to the instruction which is available in the package of patient plate. A significant point about dual pad patient plate: Since this kind of patient plate has two pads, producing sufficient contact surface with the patient s skin is very significant. If the contact surface reduces, for example because of patient reposition, the unit should alarm and attract your attention (REM system). Dual Pad Figure 31: Dual pad patient plate Utilizing dual pad plate will reduce the risk of accidental burns in the contact site of the pad with the patient's skin. Caution: Always check insulation of connecting cable of neutral electrode and get confident of insulation accuracy. Figure 32: Silicon patient plate 55
Kavandish System Eng. Co. D) Footswitch Figure 33: Double Footswitch Footswitch The footswitch receptacle accepts four-pin self-retaining plug and is compatible only with following types: Kavandish, Erbe. The receptacle can be firmly screwed to the footswitch plug. Utilize the double-footswitch to activate monopolar and bipolar applications. Depress the yellow pedal to select cutting and the blue pedal to select coagulation mode. Furthermore, if both pedals were depressed simultaneously, the generator could not be activated. Do not transport it with the cable. Avoid any pressure to the 56
MATIN Meg1 Instruction Manual connection. Do not lay the cable in loop. Do not wind the cable around pedal firmly. In the event of using the non-ap pedals, do not clean and disinfect them with the explosive substance. Do not use in medical site, i.e. 25-centimeter site where the leakage of combustible anesthetic gases may occur. Figure 34: Location that only AP footswitches can be used 57
Kavandish System Eng. Co. E) Bipolar accessories There are various types of bipolar accessories in shapes and dimensions well suited to cutting and coagulation the tissues. 28.5mm 44mm The Bipolar receptacle only accepts following types of cables: 1- Bipolar cable with shrouded Martin type connector.(50) 2- Bipolar cable with international connectors with two pins ø 4mm. (49,51 or 49,52) 3- Bipolar cable with Valleylab type connector {dual pins ø 4mm with 28.5mm distance(49,51)}. 4- Bipolar cable with Valleylab type connector {dual pins ø 4mm with 44mm distance(49,52)}. Kavandish only recommends following types of Bipolar accessories for Meg1. Bowa, Martin, Tecno, Valleylab, Berchtold. It should be mentioned while utilizing LigaSmart mode you should apply special accessories which their output connectors are compatible with accessories of famous companies for instance Valleylab, Bowa, Martin. 58 Figure 35: Bipolar Forceps
MATIN Meg1 Instruction Manual F) Bipolar Cutting This technique is applied by an especial pen. Refer to Figures 36 and 37to observe two types of these pens. These pens are equipped with two poles. One of these poles is a thin needle shaped electrode which is well suited for cutting the tissue and the other pole is the steel cover of the pen which completes the current return path. Figure 36: one type of Bipolar cutting pencil Figure 37: 0ne type of Bipolar cutting forceps 59