Ethicon Megadyne Electrosurgical Generator Operators Manual Rev D

Electrosurgical Generator MEGEN1 Operator’s Manual

Table of Contents Overview...2 Standard Conventions Used...2 Chapter 1- General Information...3 A. Introduction & General Description...3 B. Indications for Use...3 C. Contraindications...3 D. Undesirable Side Effects / Residual Risk...3 E. Device Description...3 F. How Supplied...3 G. General Warnings...4 H. Precautions...5 I. Customer Service...6 Chapter 2- Operating Instructions...7 Front Panel Controls, Indicators, and Receptacles... 11 Cut Modes... 12 Coag Modes... 13 Bipolar Modes... 14 Bipolar Current Meter... 15 Patient Return Electrode Alarm... 16 Rear Panel Controls, Indicators, and Receptacles...17 Chapter 3- Trouble Shooting and Error Codes... 21 Chapter 4- Cleaning, Disinfection, Preventive Maintenance and Repair... 24 Chapter 5- Conformation to Standards... 26 Appendix... 27 Technical Specification...27 Operating Environment...27 Storage Environment...28 Output Power Characteristics...28 Declaration for Electromagnetic Emissions...30 Declaration for Electromagnetic Immunity...31 Approved Accessories...31 Connection to External Systems... 32 Symbols...33 Power Curve Graphs...36 Glossary...50

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Electrosurgical Generator MEGEN1 Operator’s Manual

Overview Please read all information carefully.

Failure to properly follow the instructions may lead to serious surgical consequences. This manual contains important information for operation of the Electrosurgical Generator MEGEN1. It should be kept where it may be referenced during usage. Print or copy pages as necessary to keep nearby. Go to www.e-ifu.com for the latest version of this manual.

Standard Conventions Used The Use of WARNING, Precaution, and Note Statements Information relative to the completion of a task in a safe and thorough manner will be supplied in the form of a WARNING, a Precaution, or a Note statement. These statements are found throughout the documentation.

These statements should be read before continuing to the next step in a procedure. WARNING: A Warning statement indicates an operating or maintenance procedure, practice, or condition that, if not strictly observed, could result in personal injury or loss of life.

Precaution: Information regarding any special care users should exercise for the safe and effective use of the device, or to avoid damage to the device that could occur as a result of use, including misuse

Note: A Note statement indicates an operating or maintenance procedure, practice, or condition that is necessary to accomplish a task efficiently.

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Electrosurgical Generator MEGEN1 Operator’s Manual

Chapter 1- General Information A. Introduction and General Description

This manual is a guide for the proper use of the Ethicon Megadyne™ ESU. The equipment described herein is for use by qualified medical personnel skilled in the particular techniques and procedures to be performed. The Ethicon Megadyne™ ESU is intended for use in an operating theatre or surgical setting only by healthcare professionals experienced and trained in the operation of electrosurgical equipment. It is not intended for home use, in ambulances or in hospital transport. The Ethicon Megadyne™ ESU and its accessories are not intended for implant into a patient. It is intended for use on the general population with no patient age limit. For additional information on Electrosurgery please see Ethicon continuing education programs, “The Basics of Electrosurgery” and “Principles of Electrosurgery.”

B. Indications for Use

The Ethicon Megadyne™ Electrosurgical Generator (ESU) 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.

C. Contraindications None

D. Undesirable Side Effects / Residual Risk

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the local competent authority of the country in which the user and/or patient is established. Undesirable side effects and risks associated with the Ethicon Megadyne™ Electrosurgical Generator may result from generator malfunction and/or inadequate uses, including the potential for bleeding, tissue injury, nerve injury, thermal damage, acute and reversible dysfunction of organs or electrical shock. Due to use of the integrated system, burn injury is possible in an oxygen rich environment with flammable materials and infection may occur from introduction of non-sterile surfaces.

E. Device Description

The Ethicon Megadyne™ Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed to produce radio frequency (RF) current for use in monopolar cutting and coagulation and bipolar coagulation of tissue.

F. How Supplied The shipping box contains : 

Ethicon Megadyne™ Electrosurgical Generator ( REF MEGEN1)



Power Cord



Ethicon Megadyne™ ESU Operator’s Manual



Ethicon Megadyne™ ESU Service Manual



Other accessories are not included in this packaging and must be ordered separately. The Mega Cart ( REF 1300), The Mega Cart with Top Shelf ( REF 1300SJ), Mega Cart Shelf ( REF 1350), Mega Cart Unassembled ( REF 1300U), Monopolar Footswitch ( REF 1400JJ), Bipolar Footswitch ( REF 1450J), and Round Bipolar Footswitch ( REF 1459J) are also available for purchase separately.

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Electrosurgical Generator MEGEN1 Operator’s Manual

G. General Warnings •

Use the lowest possible power settings to achieve the desired effects. Certain devices or accessories may present a safety hazard at low power settings. For example, with argon beam coagulation, the risk of gas embolism rises if there is insufficient high frequency power to produce a rapid impermeable eschar on the target tissue.

•

When the generator is operational, keep active accessories away from the patient and away from the return electrode when not in use. Alternatively, store the active accessories in an electrically isolated container in a clean, dry, highly visible area. Inadvertent contact with the patient may result in burns.

•

The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N20) and oxygen shall 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.

•

If flammable agents are used for cleaning or disinfecting, or as solvents of adhesives, evaporation should be allowed 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.

•

For surgical procedures where the HF current could flow through parts of the body having a relatively small crosssectional area (e.g. circumcisions), the use of bipolar techniques is recommended in order to avoid unwanted tissue damage.

•

Do not operate the electrosurgical generator with the cover removed. Removal of the generator cover may create the risk of an electrical shock. Please contact Ethicon, or your local representative for proper servicing.

•

Electrosurgical instruments used with the generator that are activated or hot from use can cause a fire. The surface of the instrument may remain hot enough to cause burns after the RF current is deactivated. 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.

•

The use of accessories other than those specified in the approved accessory list may result in increased emissions or decreased immunity of the Ethicon Megadyne™ ESU. The accessory RF voltage rating should be ≥ 4.0 kV peak. If accessories do not meet this rating, please refer to accessory manufacturer’s instructions for recommended rated voltage. Power settings may need to be limited to accommodate accessory voltage ratings.

•

To avoid risk of electrical shock, use grounded AC outlets when connecting the generator power cord.

•

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

•

No modification to this equipment is allowed.

•

This device is not MRI safe and is not MRI compatible.

•

When using HF current there is a risk of neuromuscular stimulation, especially with modes which produce electrical arcs between the active electrode and tissue.

•

Use of equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the equipment and the other equipment should be observed to verify that they are operating normally.

•

Portable RF communications equipment (including peripherals such as antenna cables and external antennae) should be used not closer than 12 inches (30 cm) to any part of the generator including cables specified by the

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Electrosurgical Generator MEGEN1 Operator’s Manual •

manufacturer. Otherwise, degradation of the performance of this equipment could result. For patients with cardiac pacemakers, electrically conductive or other active implants, a possible hazard exists due to the concentration or re-direction of HF currents. The pacemaker or other active implant may be damaged due to the interference of HF currents. In case of doubt, approved qualified advice should be obtained from the device manufacturer.

•

Electrosurgical cables should be positioned to minimize contact with the patient and avoid contact with other leads to avoid adversely influencing the operation of other electronic equipment.

•

Studies indicate smoke generated during Electrosurgery may be harmful to surgical staff. Use of appropriate personal protection equipment (PPE) and proper smoke ventilation as provided by a surgical smoke evacuation system is recommended. 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. Connect adapters and accessories to the Ethicon Megadyne™ ESU only when the energy is off. Failure to do so may result in an injury or electrical shock to the patient or operating room personnel.

• • •

Do not buzz the Hemostat during surgical procedures.

•

When practical, the patient should not be allowed to come into contact with earthed metal parts or parts with appreciable capacitance to earth (e.g. operating table supports, etc.). Use of antistatic sheeting recommended for this purpose. It is recognized that this recommendation may not be practical during certain procedures, however, to maximize patient safety during the use of electrosurgical devices, such practices should be minimized. 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. 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.

• • •

Inspect electrode cables and endoscopically used accessories for possible damage prior to use. 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.

•

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

H. Precautions • •

Read all instructions prior to use. Federal (USA) law restricts this device to sale by or on the order of a physician.

•

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.

•

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

•

All associated equipment and active accessories should be inspected to determine the rated accessory voltage prior to use.

•

The maximum permissible length of any accessory connected to the generator, including its cord shall not exceed 15 feet (4.57 meters).

•

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.

•

If a compatible monitoring neutral electrode is not used with a contact quality monitor, loss of safe contact

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Electrosurgical Generator MEGEN1 Operator’s Manual between the neutral electrode and the patient will not result in an auditory alarm. •

The Mega Cart is recommended if the Ethicon Megadyne™ ESU is moved out of the operating room. Maintain control of the generator and cart when moving over thresholds or on incline surfaces.

•

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 currentlimiting devices are recommended. Follow manufacturers’ recommendations for proper application of monitoring 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 SoftTM 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.

•

Avoid high frequency output settings where the maximum output voltage may exceed the rated accessory voltage.

•

In the Auto Bipolar setting, activation may occur with contact of any material and without the use of a switch sensor. When not in use, place electrosurgical instruments in a safety holster or safely away from patients, the surgical team, and flammable materials.

•

Bipolar forceps should not be set down while Auto bipolar is active. Contact with any material may cause activation. Turn off Auto bipolar before releasing an instrument.

I. Customer Service Warranty The Ethicon Megadyne™ ESU is warranted to be free of defects under normal use and maintenance for one year from the date of purchase. Ethicon will repair or replace any defective parts free of charge during this time. Limited Warranty For the periods and the conditions specified below, Ethicon warrants to the original purchaser that the Ethicon Megadyne™ ESU will perform to our published specifications when used and maintained in accordance with our written instructions. The Ethicon Megadyne™ ESU is warranted to be free of defects under normal use and maintenance for one year from the date of purchase. Ethicon will, at its option, repair or replace the defective product without charge, using new or remanufactured parts. Ethicon 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 Ethicon Megadyne™ ESU will void this warranty. In addition, the warranty is null and void if the Ethicon Megadyne™ ESU 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 Ethicon Megadyne™ ESU. 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 Ethicon Megadyne ESU is as provided in this Limited Warranty. In no event shall Ethicon 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.

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Electrosurgical Generator MEGEN1 Operator’s Manual

Chapter 2- Operating Instructions Examine the Ethicon Megadyne™ ESU and its accessories for damage. Do not use damaged devices. Secure the generator on its cart or any other suitable fixture in the appropriate position. Fully insert the power cord into both the generator receptacle on the back of the generator and into the appropriate grounded outlet (figure 1). Note that generator will power on when the cord is connected. Position the generator in a manner that provides access to the power cord for disconnection. The generator will function with either the 100 to 120 or 220 to 240 volt inputs depending on the power applied to the generator.

Power cord

2x

A 4

100-240 V ~

50-60 Hz 550 W

F10.0AH/250V

Monopolar Signal

Figure 1. Foot Controls: If Footswitches are to be used for activating the active electrode, attach the monopolar, and/or bipolar Footswitch 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 receptacle.

Bipolar Footswitch cable Monopolar B Footswitch cable Monopolar A Footswitch cable

Figure 2.

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Electrosurgical Generator MEGEN1 Operator’s Manual Patient Return Electrodes: Install a patient return electrode according to the electrode manufacturer’s instructions for use. Ethicon recommends the use of the Mega Soft™ family of Reusable Patient Return Electrodes. If a return electrode is used other than those specified in the approved accessory list, please refer to manufacturer’s instruction for use. Insert the return electrode cable into the proper receptacle (figure 3).

GRECALL

|

ETHICON™

ALARM

Megadyne

XXXXXXXXX

Return 500541406 Rev A

Patient Return Electrode Figure 3.

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G

Electrosurgical Generator MEGEN1 Operator’s Manual Active Accessories: The Active Accessories are the monopolar hand switching pencils, electrodes, monopolar foot cables, and bipolar cables. Ethicon 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 pressing the standby “ON/OFF” switch. The switch will illuminate green. The generator will automatically initiate a diagnostic sequence. Verify the following: • All visual indicators and displays on the front panel illuminate. • Activation tones sound for each mode. Once the generator completes the start-up and self diagnostics check, dashed lines will be displayed in the power setting windows. Power Settings: To recall the last power setting and mode used, press the RECALL button. Power settings may also be initiated by using the up arrow button when the dashed lines are displayed on the panel. Power settings may be adjusted by using the up and down arrow buttons.

COAG :

MICRO

[BLEND

MACRO

HAND SWITCHING CABLE FOOT SWITCHING CABLE

BIPOLAR CABLE

Figure 4.

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Electrosurgical Generator MEGEN1 Operator’s Manual Modes: Select the proper mode for monopolar “CUT” and “COAG” by depressing the appropriate mode button (figure 5). The indicator light on that button will illuminate when the mode has been selected.

POWER SETTINGS WINDOW “COAG”

POWER SETTINGS WINDOW “CUT”

SPRAY

PURE

SOFT

BLEND “COAG” MODE BUTTONS “CUT” MODE BUTTONS Figure 5. Activating the Generator: Monopolar accessories attached to the monopolar hand switching receptacles may be activated by depressing either the “CUT” or “COAG” buttons on the pencil, or foot pedals. Depressing either the “CUT” or “COAG” foot pedals will deliver power to the device attached to that receptacle. 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: a colored bar will illuminate above the power display when a mode is activated. The colored bars are Yellow for CUT and Blue for COAG and BIPOLAR.

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Electrosurgical Generator MEGEN1 Operator’s Manual

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

Figure 6. Information regarding Ethicon Megadyne™ ESU functions and descriptions are detailed on the pages to follow. The following descriptions correspond to controls, indicators, and receptacles on the front panel of the generator shown below (figure 7-11)

|

ETHICON

COAG

SPRAY

COAG

SOFT

Megadyne

XXXXXXXXX (01) 1 0614559 10559 7 (11) YYMMDD (21) XXXXXXXXX 500541406 Rev A

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Electrosurgical Generator MEGEN1 Operator’s Manual

POWER Figure 8. 1. POWER: The power ON/OFF switch is located on the bottom right-hand corner of the unit. The unit is turned “ON” when the is depressed and the stand by symbol is illuminated green. The generator is turned “OFF” when the is depressed and the stand by symbol is orange. PATIENT RETURN ELECTRODE ALARM

RECALL

CUT POWER ADJUSTMENT KEYS

ETHICON

Megadyne

Figure 9. 2. RECALL: The RECALL button 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. 3

CUT: The cut controls are color coded yellow. The large numerical display indicates the power setting. The arrow ‘up’ button will increase power settings in one watt increments up to 40W and in increments of 5W thereafter to a maximum of 300W (depending on the Mode). The arrow ‘down’ button will decrease power settings in increments of five watts from 300W to 40W and in one watt increments thereafter. Selecting the “GEM” button places the generator in the GEM (Geometric Electron Modulation) cut mode. The GEM 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. The GEM button will illuminate indicating that this mode is selected. The GEM mode has low and high levels that can be adjusted with the up/down arrows. The GEM high mode is equivalent to the ACE Cut mode in the Megadyne™ Mega Power™ generator and should be used in place of the ACE mode. The GEM Mode should be used in conjunction with the GEM Blade or ACE Blade devices for maximum effectiveness.

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Electrosurgical Generator MEGEN1 Operator’s Manual Selecting the “PURE” cut button places the generator function into a standard cutting mode. The Pure cut button will illuminate when this mode is selected. This mode allows the user to manually set the desired power which is delivered during activation. The maximum power allowed in this mode is 300W. Little hemostasis is achieved when in this mode. Selecting the “BLEND” button places the generator cut function into a blended cutting mode. The Blend mode button will illuminate indicating that it is selected. The maximum power allowed in this mode is 200W. Blend provides a cutting effect and a higher level of hemostasis than either the “GEM” or “PURE” cut modes.

SPRAY

| SOFT

COAG POWER ADJUSTMENT KEYS Figure 10. 4. COAG: The coag controls are color coded blue. The large numerical display indicates the power setting. The arrow ‘up’ button 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’ button will decrease power settings in increments of 5W from 120W to 40W and in one watt increments thereafter. The Ethicon Megadyne™ ESU automatically defaults to “COAG 1” upon start up. To manually select the COAG 1 desiccation mode, simply press the COAG 1 button. The COAG 1 button will illuminate indicating that this mode is selected and active. COAG 1 The COAG 1 desiccation mode provides hemostasis to tissue that is in contact with the active electrode. In addition to providing hemostatis, COAG 1 is designed to allow the active electrode to efficiently move through tissue for coagulation with dissection during surgery. COAG 2 Pressing the “COAG 2” button activates the second coag mode. The COAG 2 mode delivers a more gradual onset of energy and may be preferred by surgeons desiring a more mild delivery of coagulation with dissection. When this mode is activated, the COAG 2 button is illuminated. SPRAY COAG Selecting the “SPRAY” button places the generator coag function into the spray, or fulguration mode. The SPRAY button will illuminate indicating that this mode is selected.

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Electrosurgical Generator MEGEN1 Operator’s Manual The SPRAY (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. SOFT COAG Pressing the SOFT button places the generator in the SOFT Coag mode. The SOFT mode desiccates tissue at a relatively slower rate with deeper thermal penetration. SOFT mode is typically used with an uncoated electrode. SOFT Coag power delivery takes place at much lower impedance than other Coag modes.

CURRENT METER

BIPOLAR POWER ADJUSTMENT KEYS

MICRO

Figure 11. 5. BIPOLAR: The BIPOLAR controls are color coded blue. The large numerical display indicates the power setting. The arrow ‘up’ button will increase power settings in increments of one watt up to 80W. The arrow ‘down’ button 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, with a bipolar Footswitch, or with the AUTO function. The Ethicon Megadyne™ ESU offers two bipolar settings, Micro Bipolar and Macro Bipolar. Micro Bipolar The Ethicon Megadyne™ ESU automatically defaults to the Micro Bipolar setting. Micro Bipolar is utilized for the majority of all bipolar cases and delivers a precise and controlled bipolar effect. The Micro Bipolar setting is designed to keep the initial voltage low to prevent sparking while delivering a consistent delivery of power to provide a tissue effect designed for all standard bipolar applications. Macro Bipolar Bipolar cases requiring a more rapid onset of power and higher voltage power output (such as tubal ligations) often require a Macro Bipolar power curve. To access the Macro Bipolar setting, simply press the Macro Bipolar button on the front panel. When this mode is activated, the Macro button is illuminated. Auto Bipolar The Auto Bipolar feature senses tissue impedance between the bipolar electrodes and uses this information to auto start or stop the delivery of bipolar energy. The user can select a long (1 second), short (0.5 second), or no delay prior to the onset of energy delivery. Go to www.e-ifu.com for latest revision of manual

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Electrosurgical Generator MEGEN1 Operator’s Manual 6. BIPOLAR CURRENT METER : The Ethicon Megadyne™ ESU Bipolar modes feature the added convenience of a built-in Bipolar Current Meter. This meter provides 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 or deactivated as desired when utilizing either of the two bipolar modes. To activate the Ethicon Megadyne™ ESU current meter bipolar tone, press the “tone” button located next to the current meter. A single “beep” will indicate the tone is active and the tone button will become illuminated. Using the recall function as noted on page 12 will also recall the bipolar tone. During use, the bipolar tone will begin with a rapid tone and reduce to a slower, metered tone as current flow is diminished. To deactivate the tone, simply press the tone button again or turn the main power switch off on the front panel. The bipolar tone is deactivated each time the system is powered off and can easily be reactivated by pressing the tone button. 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. Desiccated tissue will restrict current flow, reducing the number of lights illuminated on the bar graph. Non-desiccated tissue will allow relatively high current flows and will illuminate most of the blue lights on the bar graph. The following descriptions correspond to receptacles on the front panel of the generator shown below (figure 12a). PATIENT RETURN ELECTRODE ALARM PATIENT RETURN ELECTRODE RECEPTACLE

2

COAG

SOFT

Return

FOOT SWITCHING ACCESSORY RECEPTACLE

HAND SWITCHING ACCESSORY RECEPTACLES

BIPOLAR RECEPTACLE

Figure 12a. 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.

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Electrosurgical Generator MEGEN1 Operator’s Manual 8. Foot switching Accessory Receptacle: The Foot switching accessory receptacle on the front of the generator accepts most, 8 mm diameter male phone plug style connector from active accessory cords. Power is delivered to this receptacle when the monopolar Footswitch is attached to Footswitch receptacle A 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. Ethicon recommends use of the Mega Soft™ Reusable Patient Return Electrode family of products with the Ethicon Megadyne™ ESU. 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 ensure 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 40% from the initial measured value, the alarm will sound and the alarm symbol will be illuminated “red”. Additional information on the Patient Return Electrode Alarm can be found in the Troubleshooting Section of this Manual.

8,7mm

22,2mm

12,7mm 17,8mm

8X 4,1mm

31,8mm

Connector Dimensions Figure 12b.

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16

28,6mm

7,1mm

6,4mm

12. Determination of Master Software Version: The control software version can be determined when needed. To access the Ethicon Megadyne™ ESU control software version, press any button on the front display panel and turn on the power. An error 107 will occur and the software version will appear as a numerical value in the bipolar display. There are two numbers in the display. The first number represents the major software version and the second number represents the minor software version. Example, if the displayed number is “12”, the major version is “1” and the minor version is “2”, this will be referred to version “1.2” To clear this information from the Ethicon Megadyne™ ESU, cycle the power off and back on.

2,6mm

Electrosurgical Generator MEGEN1 Operator’s Manual

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 13). Power Entry Fuse Box Bipolar Footswitch Monopolar Footswitch Connector Connector

Volume Control Monopolar Signal Equipotential Lug Figure 13. 1.

Volume Control: The volume level is preset at the factory for all alarms. Volume control for Cut, Coag and Bipolar 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 Entry: The hospital grade 3-prong power cord supplied with the generator is inserted here to provide power to the unit.

5.

Equipotential Lug: The Equipotential 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 F10.0AH/250V).

7.

Monopolar Signal: The Monopolar Signal receptacle is provided for ECG blanking or smoke evacuation control. Activation of a device in either Monopolar port A or B results in a non-surgical Monopolar Signal (interlink) at each port in the rear of the unit. This ensures that when Monopolar activation occurs at either port, both ECG blanking and smoke evacuation may occur simultaneously.

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Electrosurgical Generator MEGEN1 Operator’s Manual

Figure 14. 8.

Under maximum power conditions, the Ethicon Megadyne™ ESU is designed to operate safely with activation times of 10 seconds on, 30 seconds off for one hour.

Footswitches The Following descriptions correspond to Footswitches compatible with the Ethicon Megadyne™ ESU. 1. Monopolar Footswitch ( REF 1400JJ) • The CUT (LEFT) pedal in yellow activates power for CUT modes. • The COAG (RIGHT) pedal in blue activates power for COAG modes.

Figure 15.

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Electrosurgical Generator MEGEN1 Operator’s Manual 2. Bipolar Footswitch ( REF 1450J) • The BIPOLAR pedal in blue activates power for BIPOLAR modes.

Figure 16. 3. Round Bipolar Footswitch ( REF 1459J) •

The round Bipolar pedal in blue activates power for BIPOLAR modes.

Figure 17.

Mega Cart The following description corresponds to the Mega Cart for use with the Ethicon Megadyne™ ESU. 1. Mega Cart ( REF 1300, REF 1300U)

Figure 18.

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