MEGAPOWER Electrosurgical Generator Operators Manual Rev K Oct 2009

The Mega Power Electrosurgical Generator is manufactured in the United States by:

Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 USA Phone: 801-576-9669 800-747-6110 (U.S.A. only)

EC

REP

Quality First International Limited Suites 317/318 Burford Business Centre 11 Burford Road Stratford, London E15 2ST U.K. Tel: +44-208-221-2361 Fax: +44-208-221-1912

©2009 Megadyne Medical Products. All rights reserved. Megadyne is a registered trademark of Megadyne Medical Products. Mega Power™ is a trademark of Megadyne Medical Products. Mega Power Patent numbers: D491,666 D491,667

1

Table of Contents 1.

Introduction…….………………………………………………………………..……...3

2.

Warnings…………………………………..…..………………………………………...…..4

3.

Cautions………..………………………………………………………………………...5

4.

Warranty and Service………………...……………………………………….…………….7

5.

Symbols……………………………………………………………………………………...8

6.

Operating Instructions.……………………………………………………………………...9

7.

Front Panel Controls, Indicators, and Receptacles………………………..…………...13 Power Switch Cut Modes: ACE, Pure Cut, ………..…………...14 Coag Modes: Standard, Coag with Cut, Spray……..……….……...15 Bipolar Mode: Bipolar Current Monitor/Meter……...… ………..……...16 Current Meter and Patient Return Electrodes and Alarm………………………..18

8.

Rear Panel Controls, Indicators, and Receptacles……………………………...19 Volume Control, Footswitch Connections, Power Cord Connection

9.

Troubleshooting……………. ……………………………………………………………...21

10. . 11.

Error Codes……………………...………………………………………………………….23

12.

Declaration for Electromagnetic Emissions……………………………………………..28

13.

Approved Accessories.…………………………………………………………..………..29

14.

Power Curve Graphs……………………………………………………………………...30

15.

Glossary…………………………………………………………………………….…….…42

Technical Specifications Safety Compliance……………………………………………25

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Introduction and General Description The Mega Power™ Electrosurgical Generator is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures. This manual is a guide for the proper use of the Mega Power electrosurgical generator. The equipment described herein is for use by qualified medical personnel skilled in the particular techniques and procedures to be performed. For additional information on Electrosurgery please see Megadyne’s continuing education programs, “Basics of Electrosurgery” and “Principles of Electrosurgery.”

Box Contents

Mega Power Electrosurgical Generator

Power Cord

User’s Manual

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Warnings •

Use the lowest possible power settings to achieve the desired effects.

•

When the generator is operational, keep active accessories away from the patient and return electrode when not in use, or store in an electrically isolated container.

•

The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N20) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are aspirated from the area. Non-flammable agents should be used for cleaning and disinfection wherever possible. Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of high frequency Electrosurgery. There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. Any fluid pooled in these areas should be mopped up before high frequency surgical equipment is used. Attention should be called to the danger of ignition of endogenous gases. Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of the high frequency surgical equipment.

•

Laparoscopic procedures may result in gas embolism due to insufflation of gas in the abdomen.

•

Electrosurgery should not be used to perform circumcisions.

•

For surgical procedures where the high frequency current could flow through parts of the body with relatively small cross sectional area, the use of bipolar techniques may be desirable.

•

Cautery tips that are activated or hot from use can cause a fire. Do not place them near or in contact with flammable materials and substances (e.g. drapes, flammable gases, endotracheal tubes, etc.).

•

Failure of the high frequency surgical equipment could result in an unintended increase of output power.

•

Do not operate the electrosurgical generator with the cover removed.

•

The use of accessories other than those specified on page 29 may result in increased emissions or decreased immunity of the Mega Power Electrosurgery Generator.

4

Cautions •

Read all instructions prior to use.

•

Use grounded AC outlets when connecting the generator power cord.

•

Do not place containers of fluids on the generator, or allow fluids to spill on the generator.

•

Do not operate the generator without adequate clearance for ventilation. The space between the bottom of the feet and floor of the generator should be clear of obstruction. At least two inches of air should separate sides, back, and top of the generator from any ventilation-obstructing surface.

•

Removal of the generator cover may create the risk of an electrical shock. Please contact Megadyne, or your local representative for proper servicing.

•

The clinical use of Electrosurgery is by nature intermittent. This system should be operated intermittently as well. Prolonged use may cause over heating.

•

Connect accessories (e.g. pencil, foot cord, bipolar instruments, return electrode, etc.) to the proper receptacle. Use connectors designed for the intended purpose. Follow the instructions for use provided by accessory manufacturers.

•

Apparent low power output or failure of the electrosurgical equipment to function correctly at normal settings may indicate faulty application of the dispersive electrode or failure of an electrical lead. Do not increase power output before checking for obvious defects or misapplication. For monopolar surgery, effective coupling between the patient and the dispersive electrode must be verified whenever the patient is repositioned.

•

For patients with cardiac pacemakers or other active implants, a possible hazard exists due to the potential for interference with the action of the pacemaker, or the pacemaker may be damaged. In case of doubt, approved qualified advice should be obtained from the device manufacturer.

•

The cables to the surgical electrodes should be positioned in such a way that contact with the patient or other leads is avoided.

•

As with all medical systems generating high RF, the Mega Power may interfere or affect the functionality of other electronic equipment. Precautions should be taken during equipment installation to reduce this condition. Megadyne recommends moving other electronic equipment away from the generator and to separate cables within the room from the RF carrying cables.

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Cautions, continued •

Patient monitoring electrodes should be placed as far from the surgical electrodes as possible. Needle monitoring electrodes should be avoided. Patient monitoring systems using high frequency current-limiting devices are recommended. Follow manufacturers’ recommendations for proper application of monitoring electrodes.

•

When practical, the patient should not be allowed to come into contact with metal parts. It is recognized that this recommendation may not be practical during certain procedures (e.g., those in which uninsulated head frames are used); however, to maximize patient safety during the use of electrosurgical devices, such practices should be minimized.

•

Skin-to-skin contact (i.e., between the arms and body of the patient) should be avoided. Insertion of non-conductive materials between the skin-to-skin contact sites is recommended.

•

The use and proper placement of a dispersive electrode is a key element in the safe and effective use of monopolar Electrosurgery, particularly in the prevention of pad site burns. Follow manufacturer’s directions and recommended practices for the preparation, placement, surveillance, and use of dispersive electrodes.

•

For disposable, adhesive type (“sticky”) return electrodes the entire area of the return electrode should be reliably attached to the patient’s body and as close to the operating field as possible. Place the adhesive type return electrode over good muscular, vascular, tissue. Avoid areas of hair, fat, bony prominences and metal implants.

•

For the Mega Soft™ family of Reusable Patient Return Electrodes, maximize the patient weight bearing area on the pad and minimize the materials placed between the pad and patient.

•

Regularly inspect electrosurgical accessories for damage. In particular, electrode cables and endoscopic accessories should be checked for damaged insulation.

•

Do not activate an electrode until it is in contact with (for desiccation), or in close proximity (for fulguration) to the target tissue.

•

Do not coil electrosurgical accessory cords, and do not wrap electrosurgical accessory cords around metal objects. This may induce current flow to unintentional areas causing, shocks, burns, or fires.

•

Studies indicate smoke generated during Electrosurgery may be harmful to surgical staff. Use of a surgical mask and proper smoke ventilation as provide by a surgical smoke evacuation system is recommended.

•

Federal (USA) law restricts this device to sale by or on the order of a physician.

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Warranty The Megadyne Mega Power electrosurgical generator is warranted to be free of defects under normal use and maintenance for two years from the date of purchase. Megadyne will repair or replace any defective parts free of charge during this time. Limited Warranty For the periods and the conditions specified below, Megadyne warrants to the original purchaser that the Mega Power Electrosurgical Generator will perform to our published specifications when used and maintained in accordance with our written instructions. The Mega Power Electrosurgical Generator is warranted to be free of defects under normal use and maintenance for two years from the date of purchase. Megadyne will, at its option, repair or replace the defective product without charge, using new or remanufactured parts. Megadyne reserves the right to make a repair in its factory, at any authorized repair facility, or at the purchaser’s premises. An unauthorized repair of the Mega Power Electrosurgical Generator will void this warranty. In addition, the warranty is null and void if the Mega Power Electrosurgical Generator is used other than is specified in the Operator’s Manual. Without limitation, the warranty does not cover damage caused by customer misuse of the Mega Power Electrosurgical Generator. THIS WARRANTY IS IN LIEU OF ANY OTHER WARRANTIES EXPRESSED OR IMPLIED, AND ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IS EXPRESSLY DISCLAIMED. Purchaser’s exclusive remedy for any failure of the Mega Power Electrosurgical Generator is as provided in this Limited Warranty. In no event shall Megadyne be liable for any special, incidental, consequential, indirect or other similar damages arising from break of warranty, break of contract, negligence or any other legal theory.

Maintenance/Service It is recommended that maintenance calibration testing be performed at annual intervals. Specific calibration testing is outlined in the Mega Power Service Manual. In addition to calibration testing routinely inspect the power cord, footswitch cables, and connectors for any signs of damage. Replace damaged cords and/or connectors immediately. Should your Mega Power Electrosurgical Generator require service/repair please contact Megadyne’s Customer Service department to obtain a Returned Goods Authorization (RGA) number. Return the generator in its original packaging if possible with the RGA number written on the address label to: Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 USA Phone: 801-576-9669 800-747-6110 (U.S.A. only)

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Symbols Symbol

Description

|

ON (Power)

O

OFF (Power) Read instructions prior to use

Generator output is floating with respect to ground

Defibrillator proof type CF equipment

Dangerous Voltage

Equipotentiality

Foot Switch

Speaker

Fuse

Return electrode connection

Hand control receptacle

Foot control receptacle

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Operating Instructions With the generator in the “OFF” position be sure that the power cord is fully inserted into both the generator receptacle on the back of the generator and into the appropriate grounded outlet (figure 1). The generator will function in either the 100 or 240 volt modes depending on the power applied to the generator.

Figure 1. Foot Controls: If footswitches are to be used for activating the active electrode, attach the monopolar, and/or bipolar foot controls to their appropriate receptacles while the generator is in the “off” position (figure 2). If footswitches are not used during the procedure disconnect the footswitches from their receptacles.

Figure 2. 9

Patient Return Electrodes: Install a patient return electrode according to the electrode manufacturer’s instructions for use. Megadyne recommends the use of the Mega Soft™ family of Reusable Patient Return Electrodes, however, the Mega Power Electrosurgical Generator is compatible with all approved return electrodes. Insert the return electrode cable into the proper receptacle (figure 3).

Figure 3.

Figure 3.

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Active Accessories: The Active Accessories are the monopolar hand switching pencils, electrodes, monopolar foot cords, and bipolar cords. Megadyne recommends the use of the Megadyne family of Active Accessories, including E-Z Clean electrodes. Fully insert the Active Accessories into their appropriate receptacles ensuring that no metal is exposed (figure 4) Powering the Generator: Turn on the generator by placing the “ON/OFF” switch into the “ON” position. Once the generator completes the start-up and self check routines of approximately 8 seconds, the power displays will show dashed lines. Power Settings: To recall the last power setting and mode used, press the RECALL key. Power settings may also be initiated by using the up arrow key when the dashed lines are displayed on the panel. Power settings may be adjusted by using the up and down arrow keys.

Figure 4.

Figure 4.

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Modes: Select the proper mode for monopolar “CUT” and “COAG” by depressing the appropriate mode key (figure 5). The indicator light on that key will illuminate when the mode has been selected.

Figure 5. Activating the Generator: Monopolar accessories attached to the monopolar hand switching receptacles may be activated by depressing either the “CUT” or “COAG” keys on the pencil, or foot pedals. Depressing either the “CUT” or “COAG” foot pedals will deliver power to the device attached to that channel. Only one active device may be plugged into each channel at a time (i.e. either the 3-prong pencil cord, or phone plug style cord). Note: Only one monopolar accessory can be activated at a time. Depressing the single footswitch of the bipolar foot control will activate bipolar instruments attached to the bipolar receptacles. For bipolar hand switching devices, closing the tips of the bipolar forceps will engage the switch on the instrument and will activate the device. Note: The cut or coag display will become brighter when activated, while the unused display will dim. Cleaning: Disconnect the power cord from the wall outlet prior to cleaning the generator. Use a mild detergent, or disinfectant to clean the generator. Abrasive cleaners will scratch the displays. Do not allow fluids to drain inside the generator.

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Front Panel Controls, Indicators, and Receptacles The Mega Power generator is designed as a full-functioning, easy to use electrosurgical unit for cutting and coagulating tissue (figure 6).

Figure 6.

Information regarding Mega Power functions and descriptions are detailed on the pages to follow.

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The following descriptions correspond to controls, indicators, and receptacles on the front panel of the generator shown below (figure 7).

Figure 7. 1.

POWER: The power on/off switch is located in the top left-hand corner of the unit. The unit is turned “ON” when the ‘|’ is depressed and the light above the switch illuminates. The generator is turned “OFF” when the ‘o’ is depressed and the light above the switch is extinguished.

2.

CUT: The cut controls are color coded yellow. The large numerical display indicates the power setting. The arrow ‘up’ key will increase power settings in one watt increments up to 40W and in increments of 5W thereafter to a maximum of 300W. The arrow ‘down’ key will decrease power settings in increments of five watts from 300W to 40W and in one watt increments thereafter. Selecting the “ACE” key places the generator in the ACE (Advanced Cutting Effect) cut mode. The ACE mode automatically controls the output power of the generator to provide the surgeon with a consistent cutting effect. Little hemostasis is achieved in this mode. In the ACE mode the light on the key will illuminate indicating that this mode is selected, and the power display will show “ACE”. Power can not be manually adjusted by using the up and down arrow keys. Selecting the “PURE” key places the generator function into a standard cutting mode. The light on the key will illuminate indicating that this mode is selected. The standard cut, or PURE mode allows the user to manually set desired power which is delivered during activation. Little hemostasis is achieved when in this mode. Selecting the “BLEND” key places the generator cut function into a blended cutting mode. The light on the key will illuminate indicating that it is selected. This is a mix of the cutting and coagulation waveforms. The maximum power allowed in this mode is 200W. It provides a cutting effect and a higher level of hemostasis than either the “ACE” or “PURE” cut modes. During the case, the last BLEND setting used will remain in memory until the mode or power setting is changed. Once the generator is turned Off, and On again, depressing the RECALL button will recall the last mode and power setting used. 14

3.

COAG: The coag controls are color coded blue. The large numerical display indicates the power setting. The arrow ‘up’ key will increase power settings in increments of one watt up to 40W and in 5W increments thereafter to a maximum of 120W. The arrow ‘down’ key will decrease power settings in increments of five watts from 120W to 40W and in one watt increments thereafter. Selecting the “STANDARD” key places the generator coag function into the desiccation mode. The light on the key will illuminate indicating that this mode is selected. The desiccation mode provides hemostasis to tissue that is in contact with the active electrode and provides diminished cutting effect when compared to cut modes. Coag with Cut Mode To achieve more cutting effect in the STANDARD Coag mode, press the Pure Cut and the Standard Coag buttons simultaneously. This activates a second coag mode (Coag with Cut) for surgeons desiring a mild cutting effect during coagulation. When this mode is activated, the Standard Coag button will “blink” on and off. To return to the Standard Coag mode, simply press the Standard Coag button once, or go to Spray Coag and back to the Standard Coag mode. The blinking light will turn to a solid light and you will be returned to the Standard Coag mode. Powering down the system will also return the Mega Power to the Standard Coag mode. The second Coag mode can easily be recalled (if it was the last mode used) upon start up by pressing the RECALL key or simply use the instructions above to activate the mode Selecting the “SPRAY” key places the generator coag function into the spray, or fulguration mode. The light on the key will illuminate indicating that this mode is selected. During the case, the last SPRAY setting used will remain in memory as a convenience to users when toggling between modes during a case. Once the generator is turned Off, and On again, depressing the SPRAY mode will change the mode, but not the power setting for patient safety. The fulguration mode uses higher peak to peak voltages to allow current to “jump” from the active electrode through air to the target tissue producing sparks. This provides hemostasis in a more broad area with less depth of tissue damage when compared to desiccation. The SPRAY coag mode provides diminished cutting effect when compared to cut modes. 4. RECALL: The RECALL key is provided as a convenience to users and recalls the last mode and the last power setting used after the system is turned on, and the recall button is pushed. During use, toggling between modes will maintain the last power setting used. 15

5. .Bipolar: The BIPOLAR controls are color coded blue. The large numerical display indicates the power setting. The arrow ‘up’ key will increase power settings in increments of one watt up to 80W. The arrow ‘down’ key will decrease power settings in increments of one watt. When the bipolar mode is used the current will flow between the two tips of the instrument and will desiccate tissue. The bipolar mode can be activated with either a hand switching device, or with a bipolar footswitch. The Mega Power offers two bipolar settings, a standard/micro bipolar and a macro bipolar. Standard/Micro Bipolar The Mega Power automatically boots up in the Standard/Micro bipolar setting. This setting is utilized for the majority of all bipolar cases and delivers a precise and controlled bipolar effect. The initial voltage is kept low to prevent sparking and the system maintains a specific power curve to achieve the proper tissue effect.

Macro Bipolar Bipolar cases requiring a more rapid onset of power and higher voltage power output utilize a macro bipolar power curve. To access the Macro bipolar setting, simultaneously press the Standard and Spray Coag buttons as instructed below.

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6. Mega Power Bipolar Current Meter The Mega Power Electrosurgical Generator Bipolar macro setting features a Bipolar Current Meter with both a visual graph and bipolar tone to provide an indication of the amount of current flow between the tips of the bipolar instrument. Bipolar Current Meter Tone The current meter bipolar tone can be activated and deactivated when desired. To activate the Mega Power current meter bipolar tone, press the “Pure” and “Blend” keys on the front display panel simultaneously. A single tone will indicate that the bipolar current meter tone is activated. During use, the bipolar tone will begin with a rapid tone and reduce to a slower, metered tone as current flow is diminished. The bipolar current meter tone is turned off in one of two ways: 1). Press the Pure and Blend keys simultaneously. A tone will indicate the current meter bipolar tone has been disabled. 2). Or, simply turn the main power switch off on the front panel. The Mega Power bipolar current meter tone will need to be turned on as instructed above each time the unit is powered on if the tone is desired during the case. Bipolar Visual Indicator The visual indicator will appear automatically when bipolar is in use. As tissue becomes desiccated it becomes more resistive and less current flows. Non-desiccated tissue will allow relatively high current flows and will illuminate all, or most of the green lights on the bar graph. Desiccated tissue will restrict current flow, reducing the number of lights illuminated on the bar graph. 7.

Hand switching Accessory Receptacles: The two monopolar hand switching receptacles are designed to accept standard three-prong active accessory devices (e.g. an electrosurgical pencil). Either receptacle may be used. Note: Only one monopolar accessory can be activated at a time.

8.

Foot switching Accessory Receptacle: The Foot switching accessory receptacle on the front of the generator accepts most, 8 mm diameter male style phone plug style connector from active accessory cords. Power is delivered to this receptacle when the monopolar footswitch is attached to the appropriate receptacle on the back of the generator and is depressed by the operator. Note: Only one monopolar accessory can be activated at a time.

9.

Bipolar Receptacle: The bipolar receptacle can accept either a foot switching accessory or a hand switching accessory. A foot switching instrument requires the two large connectors to be inserted into the two mating receptacles. A hand switching instrument uses an additional male pin on the molded connector which is inserted into the smaller mating receptacle. Note: Bipolar and monopolar accessories may not be activated simultaneously.

10.

Patient Return Electrode Receptacle: This receptacle accepts both single plate and split plate return electrodes. Megadyne recommends use of the Mega Soft Reusable Patient Return Electrode family of products with the Mega Power electrosurgical generator. 17

11.

Patient Return Electrode Alarm: When the generator is turned “ON” with nothing inserted into the Patient Return Electrode Receptacle, the pad alarm will be illuminated “red” and the alarm will sound. When a single plate pad is plugged into the receptacle with a sufficient connection the alarm light will turn “green”. When a monitoring, or split pad is plugged into the patient return electrode receptacle the generator performs a test to insure that the pad is properly attached to the patient. When the pad is properly installed the alarm icon will be illuminated “green”. If excessive impedance is detected in the split pad or the impedance increases by more than 30% from the initial measured value, the alarm will sound and the alarm symbol will be illuminated “red”. Megadyne recommends use of the Mega Soft Reusable Patient Return Electrode family of products with the Mega Power electrosurgical generator. Additional information on the Patient Return Electrode Alarm can be found in the Troubleshooting Section of this Manual.

12.

Determination of Master Software Revision The master control software revision can be determined when needed. To access the Mega Power master control software revision, press any key on the front display panel and turn on the power. An error 207 will occur and the software revision will appear as a numerical value in the bipolar display. The numeric value corresponds to an alphabetical letter that is equivalent to the letter position in the English alphabet. Example, the letter A is alphabet letter number 1 and the letter R is alphabet letter number 18 thus, number 18 in the bipolar display indicates the master software is revision R. To clear this information from the Mega Power cycle the power off and back on.

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Rear Panel Controls, Indicators, and Receptacles The following descriptions correspond to controls, indicators, and receptacles on the back panel of the generator shown below.

Figure 8. 1.

Volume Control: The volume level is preset at the factory for all alarms. Volume control for Cut and Coag tones may be increased by turning the knob in a clockwise direction, and decreased by turning the knob in a counter-clockwise direction.

2.

Monopolar Footswitch Connector: A Megadyne two pedal footswitch is connected by inserting the keyed connector into the proper receptacles and tightening the threaded collar. The Monopolar A footswitch will activate accessories attached to the A receptacles on the front of the generator. The B footswitch will activate accessories in the B receptacles on the front of the generator.

3.

Bipolar Footswitch Connector: A Megadyne one pedal footswitch is connected by inserting the keyed connector into the proper receptacle and tightening the threaded collar.

4.

Power Cord Connector: The hospital grade 3-prong power cord supplied with the generator is inserted here to provide power to the unit.

5.

Grounding Lug: The grounding lug is provided for additional grounding of the chassis when required.

6.

Fuse Box: The fuse box can be accessed by using a small flat instrument to open the drawer and pulling the receptacle towards you. If the fuse has been damaged replace with the proper size fuse (two each F10.0/250V).

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