Ethicon Megadyne Electrosurgical Generator Service Manual Rev B April 2020

Table of Contents 1. Preface ... 1 2. Introduction and General Description ...1 3. Limited Warranty ... 2 4. Maintenance/Service ... 2 5. Warnings ... 4 6. Cautions ... 5 7. Symbols ... 7 8. Preventative Maintenance and Calibration Check... 9 9. Low Frequency Electrical Safety Test ... 13 10. Error Codes... 14 11. Troubleshooting ... 16 12. Technical Specifications ... 17 13. Output Power Characteristics... 18 14. Declaration for Electromagnetic Emissions... 20 15. Approved Accessories ... 21 16. Parts/Assemblies ... 21 17. Power Curve Graphs ... 23 18. Appendix ... 37 19. Ethicon Megadyne ESU Preventative Maintanence and Calibration Check ... 38

Preface This service manual is intended for maintaining and servicing the Ethicon Megadyne™ Electrosurgical Generator. For clinical and operational instructions for this system, please refer to the Ethicon Megadyne™ Operator’s Manual.

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.

Introduction This manual describes the attributes and specifications of the generator, and provides a guide to the procedures necessary for preventative maintenance and safety testing. For reasons of personnel safety and continuing reliability, the generator should not be calibrated, or internally examined by anyone except Ethicon or persons trained by Ethicon. If the work is not performed by trained persons, Ethicon accepts no liability and warranty rights become void. The equipment descrided herein is for use by qualified medical personnel skilled in the use particular techniques and procedures to be performed. Using the appropriate approved accessories, the qualified medical personnel identifies the part of the body and/or target tissue for cutting and/or coagulation during the procedure. The reusable Ethicon Megadyne™ ESU is to be used in an operating theatre or a surgical setting only. It is not to be used for home use , in ambulances, or during hospital transport. The Ethicon Megadyne™ ESU is not to be used as a permanent implant in a patient. It may be used for use on the general population (with multiple patients) with no patient age limit.

Description The Ethicon Megadyne™ Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulating of tissue. The Generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.

Box Contents ƒ

Ethicon Megadyne Electrosurgical Generator ( REF MEGEN1)

ƒ

Power Cord

ƒ

Ethicon Megadyne ESU Operator’s Manual

ƒ

Ethicon Megadyne ESU Service Manual

ƒ

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

1

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. Megadyne 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.

Maintenance/Service It is recommended that safety checks, preventive maintenance, and calibration testing be performed at annual intervals by personnel that have training in electronics such as Biomeds in hospitals. Service of the Ethicon Megadyne™ ESU would be required if safety checks and preventative maintenance show the generator is out of tolerance. For servicing activities, the Ethicon Megadyne™ ESU may be returned to an authorized EES service facility at any time. Contact the Ethicon Endo-Surgery Customer Service Department or your local representative for any customer or technical support. Call 1-877-ETHICON (1-877-384-4266) in U.S. only

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Returning the Generator for Service Before you return the generator, call Ethicon for assistance. If you are instructed to send the generator to Ethicon for service, obtain a Return Authorization Number. Then, clean the generator and ship it to Ethicon for service. Step 1 - Obtain a Return Authorization Number Call the Ethicon Customer Service Center for your area to obtain a Return Authorization Number. Have the following information ready. •

Hospital / clinic name / customer number

•

Telephone Number

•

Department / address, city, state, and zip code

•

Serial number

•

Description of problem

Step 2 - Clean the generator A. Turn off the generator, and unplug the power cord from the wall outlet. B. Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth. Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the chassis. The generator cannot be sterilized. Step 3 - Ship the generator A. Attach a tag to the generator that includes the Return Authorization Number and the information (hospital, phone number, etc.) listed in Step 1 - Obtain a Return Authorization Number. B. Package in the original Ethicon Megadyne ESU shipping container, if available. C. Ship the generator to Ethicon Service Center. Request approved shipping materials if necessary from Ethicon.

3

Warnings ƒ 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. ƒ 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 in a clean, dry, highly visible area. Inadvertent contact with the patient may result in burns. ƒ 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.

ƒ Non-flammable agents should be used for cleaning and disinfection wherever possible. ƒ 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. ƒ Laparoscopic procedures may result in gas embolism due to insufflation of gas in the abdomen. ƒ For surgical procedures where the HF current could flow through parts of the body having a

relatively small cross sectional area (e.g. circumcisions), the use of bipolar techniques may be desirable in order to avoid unwanted tissue damage. ƒ Do not operate the electrosurgical generator with the cover removed. ƒ Cautery tips that are activated or hot from use can cause a fire. The surface of the electrode

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.). ƒ Failure of the high frequency surgical equipment could result in an unintended increase of

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

power cord. ƒ 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. ƒ No modification to this equipment is allowed. ƒ When using HF current there is a risk of neuromuscular stimulation, especially with modes

which produce electrical arcs between the active electrode and tissue. ƒ 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.

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Warnings, continued ƒ 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 manufacturer. Otherwise, degradation of the performance of this equipment could result. ƒ 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. ƒ 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. ƒ Studies indicate smoke generated during Electrosurgery may be harmful to surgical staff. Use of a surgical mask and proper smoke ventilation as provided by a surgical smoke evacuation system is recommended. Ɣ 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 electical shock to the patient or operating room personnel..

Cautions ƒ Read all instructions prior to use. ƒ Federal (USA) law restricts this device to sale by or on the order of a physician. ƒ Do not place containers of fluids on the generator, or allow fluids to spill on the generator. ƒ 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 ventilationobstructing surface. ƒ Removal of the generator cover may create the risk of an electrical shock. Please contact

Ethicon, or your local representative for proper servicing. ƒ The clinical use of Electrosurgery is by nature intermittent. This system should be operated

intermittently as well. Prolonged use may cause over heating. ƒ Failure of the electrosurgical generator could result in an unintended increase of output power. ƒ 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. ƒ All associated equipment and active accessories should be inspected to determine the rated

accessory voltage prior to use. ƒ The maximum permissible length of any accessory connected to the generator, including its

cord shall not exceed 15 feet (4.57 meters). ƒ 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. ƒ If a compatible monitoring neutral electrode is not used with a contact quality monitor, loss of

safe contact between the neutral electrode and the patient will not result in an auditory alarm. ƒ The cables to the surgical electrodes should be positioned in such a way that contact with the patient or other leads is avoided.

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Cautions, continued ƒ 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. ƒ 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. ƒ 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. ƒ 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. ƒ 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. ƒ 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. ƒ 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. ƒ Regularly inspect electrosurgical accessories for damage. In particular, electrode cables and endoscopic accessories should be checked for damaged insulation. ƒ Avoid high frequency output settings where the maximum output voltage may exceed the rated accessory voltage. ƒ 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. ƒ 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. ƒ 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 ƒ 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.

6

Symbols Symbol

Description Standby (ON/OFF) Read instructions prior to use

F

Generator output is floating with respect to ground Defibrillator proof type CF equipment Dangerous Voltage Equipotentiality Foot Switch Speaker Non-ionizing Radiation Fuse Return electrode connection Hand control receptacle Foot control receptacle Waste Electrical and Electronic Equipment (WEEE) Category AP equipment. This symbol applies to foot switches only Federal (USA) law restricts this device to sale by or on the order of a physician. Alternating Current Volume Control Temperature Limit #

Humidity Limitations #

Keep Away From Heat Keep Dry Manufacturer

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Monopolar Signal A/B

Monopolar Signal receptacle for ECG Blanking or Smoke evacuation control Medical - Applied current/energy equipment as to electrical shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES60601-1: 2005/ (R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, CAN/CSA C22.2 No. 60601-1 (2008 and 2014); ANSI/AAMI/IEC 60601-2-2:2008 and 2017, CAN/ CSA-C22.2 No. 60601-2-2 (2009), E351663 The electronic information product (FIP) has met the requirements set forth by the People’s Republic of China for marking of EIP’s, and can be used during its environmental protection use period of 50 years. After the environmental protection period has expired, the EIP should be recycled. Applicable in the People’s Republic of China.

CUT

Cut

PURE

Pure Cut

BLEND

Blend

GEM

Geometric Electron Modulation

COAG

Coag

COAG 1

Coag 1

COAG 2

Coag 2

SPRAY

Spray

SOFT

Soft Coag

BIPOLAR

Bipolar

MICRO

Micro

MACRO AUTO START/ STOP RECALL

Macro

ALARM CURRENT FLOW

Alarm

Auto start/stop Recall

Current Flow Mass; weight Refer to Instruction Manual/Booklet Protective earth

This equipment rated for intermittent duty at maximum output 10 seconds on and 30 seconds off for one hour, according to IEC 60601-2-2

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

8

Preventative Maintenance and Calibration Check Instructions It is recommended that Preventative Maintenance and calibration testing be performed at annual intervals. Refer to Equipment Needed Section Below for a list of equipment necessary to perform this testing. All measurement equipment used must be able to measure true RMS. Refer to the Ethicon Megadyne™ ESU Preventative Maintenance and Calibration Check Form in the appendix of this manual (Pg. 38). Equipment Needed Ɣ

ESU analyser capable of measuring true RMS with load range of at least 100-500 ohms.

Ɣ

Test Leads for connection to generator.

Ɣ

Return electrode cable with leads shortened.

Ɣ

Monopolar Footswitch (1400JJ).

Ɣ

Bipolar Footswitch (1450J or 1459J).

Ɣ

Variable load resistor (0-200 ohms).

Ɣ

Electrical Safety Analyzer.

Ɣ

Monopolar hand switching pencil (0030 or similar).

Ɣ

Digital Multimeter

Visual Inspection and Activation 1. Visually inspect the Front Panel and Top cover for physical damage including chips and cracks. 2. Visually inspect the Power cord, footswitch cords, and footswitch connectors for physical damage, cracks or frayed insulation. 3. Power on the ESU and observe the display. All lights should illuminate and activation tones should sound during the start up routine.

Active Outputs CUT 4. Connect the Ethicon Megadyne™ ESU monopolar A output (circled in red below) to the ESU analyzer.

5. Connect the monopolar footswitch to the monopolar A footswitch recepticle. Using a return electrode cable, short the two leads from the return electrode and connect them to the ESU analyzer. 6. Set the Ethicon Megadyne™ ESU to the GEM “H” Mode, and set the ESU analyzer to 200 Ohms. 7. Activate the Ethicon Megadyne™ ESU using the footswitch. Verify the ESU output power is 120 to 180 Watts using the ESU analyzer. 8. Set the Ethicon Megadyne™ ESU to GEM “L” Mode and set the ESU analyzer to 200 Ohms. 9. Activate the Ethicon Megadyne™ ESU using the footswitch. Verify the ESU output power is 52 to 80 Watts using the ESU analyzer. 10. Set the Ethicon Megadyne™ ESU to PURE CUT @ 20 Watts, and set the ESU analyzer to 300 Ohms. 11. Activate the Ethicon Megadyne™ ESU and verify the output power is 15 to 25 Watts using the ESU analyzer.

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12. Change the power setting on the Ethicon Megadyne™ ESU to PURE CUT @ 300 Watts and set the ESU analyzer to 300 Ohms 13. Activate the Ethicon Megadyne™ ESU and verify the output power is 240 to 360 Watts using the ESU analyzer. 14. Activate the Ethicon Megadyne™ ESU and verify an audible tone while the ESU is activated. 15. Set the Ethicon Megadyne™ ESU to BLEND CUT @ 20 Watts, and set the ESU analyzer to 300 Ohms. 16. Activate the Ethicon Megadyne™ ESU and verify the output power is 15 to 25 Watts using the ESU analyzer. 17. Change the power setting on the Ethicon Megadyne™ ESU to BLEND CUT @ 200 Watts and set the analyzer to 300 Ohms. 18. Activate the Ethicon Megadyne™ ESU and verify the output power is 160 to 240 Watts using the ESU analyzer.

COAG 19. Set the Ethicon Megadyne™ ESU to COAG 1 @ 20 Watts, and set the ESU analyzer to 500 Ohms. 20. Activate the Ethicon Megadyne™ ESU using the footswitch and verify the output power is 15 to 25 Watts using the ESU analyzer. 21. Change the power setting on the Ethicon Megadyne ESU to COAG 1 @ 120 Watts and set the ESU analyzer to 500 Ohms. 22. Activate the Ethicon Megadyne™ ESU and verify the output power is 96 to 144 Watts using the ESU analyzer. 23. Activate the Ethicon Megadyne™ ESUand verify an audible tone while the ESU is activated. 24. Set the Ethicon Megadyne™ ESU to COAG 2 @ 20 Watts, and set the ESU analyzer to 500 Ohms. 25. Activate the Ethicon Megadyne™ ESU and verify the output power is 15 to 25 Watts using the ESU analyzer. 26. Change the power setting on the Ethicon Megadyne™ ESU to COAG 2 @ 120 Watts and set the ESU analyzer to 500 Ohms. 27. Activate the Ethicon Megadyne™ ESU and verify the output power is 96 to 144 Watts using the ESU analyzer. 28. Set the Ethicon Megadyne™ ESU to SPRAY COAG @ 20 Watts, and set the ESU analyzer to 500 Ohms. 29. Activate the Ethicon Megadyne™ ESU and verify the output power is 15 to 25 watts using the ESU analyzer. 30. Change the power setting on the Ethicon Megadyne™ ESU to SPRAY COAG @ 120 Watts and set the ESU analyzer to 500 Ohms. 31. Activate the Ethicon Megadyne™ ESU and verify the output power is 96 to 144 Watts using the ESU analyzer. 32. Set the Ethicon Megadyne™ ESU to SOFT COAG @ 20 Watts; and set the ESU analyzer to 140 Ohms. 33. Activate the Ethicon Megadyne™ ESU and verify the output is 15 to 25 Watts using the ESU analyzer.

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34. Change the power setting on the Ethicon Megadyne™ ESU to SOFT COAG @ 120 Watts and set the ESU analyzer to 140 Ohms. 35. Activate the Ethicon Megadyne™ ESU and verify the putput power is 96 to 144 Watts using the ESU analyzer. 36. Disconnect the Ethicon Megadyne™ ESU monopolar A output from the ESU analyzer and connect a hand switching monopolar pencil to monopolar A. 37. Change the power setting of CUT and COAG to 1 Watt. Activate the Ethicon Megadyne™ ESU using the hand switch on both CUT and COAG and verify the generator is activated and an audible is present for each activation. 38. To test the Monopolar B channel, connect the Ethicon Megadyne™ ESU monopolar B output (circled in red below) to ESU analyzer and connect the monopolar footswitch to the monopolar B footswitch receptacle. Repeat steps 6 through 37.

BIPOLAR 39. Disconnect the Ethicon Megadyne™ ESU monopolar output to the ESU analyzer and connect the Bipolar output (circled in red below) to the ESU analyzer.

40. Connect the bipolar footswitch to the bipolar footswitch recepticle. 41. Set the Ethicon Megadyne™ ESU to MICRO BIPOLAR @ 10 Watts, and set the ESU analyzer to 100 Ohms. 42. Activate the Ethicon Megadyne™ ESU and verify the output power is 5 to 15 Watts using the ESU analyzer. 43. Change the power setting on the Ethicon Megadyne™ ESU to MICRO BIPOLAR @ 80 Watts and set the ESU analyzer to 100 Ohms. 44. Activate the Ethicon Megadyne™ ESU and verify the output power is 64 to 96 Watts using the ESU analyzer. 45. Activate the Ethicon Megadyne™ ESU using the bipolar footswitch, verify an audible tone while the ESU is activated. 46. Set the Ethicon Megadyne™ ESU to MACRO BIPOLAR @ 10 Watts, and set the ESU analyzer to 100 Ohms. 47. Activate the Ethicon Megadyne™ ESU and verify the output power is 5 to 15 Watts using the ESU analyzer. 48. Change the power setting on the Ethicon Megadyne™ ESU to MACRO BIPOLAR @ 80 Watts and set the ESU analyzer to 100 Ohms.

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49. Activate the Ethicon Megadyne™ ESU and verify the output power is 64 to 96 Watts using the ESU analyzer. Contact Quality Monitoring (CQM) Test. This test requires test leads to connect to the CQM receptacle, fixed load resistors, a multimeter, and a variable load resistor. 50. Set the potentiometer to resistance called out in the “Verify Potentiometer Calibration” Table of the test form. 51. With a digital multi meter measure the resistance across the potentiometer. 52. Turn on the Ethicon Megadyne™ ESU without a return electrode plugged in. The alarm light should be red. 53. Attach a 50 Ohm load across the two wires of the test lead. Plug the CQM Test lead into the Patient Return Receptacle. The alarm light should turn green. 54. Unplug the CQM Test lead from the ESU, the alarm should sound and the light should turn red. 55. Attach a 150 Ohm load across the two wires of the test lead. Plug the CQM Test lead into the Patient Return Receptacle. The alarm light should remain red. 56. Unplug the CQM Test lead from the ESU. 57. Attach a variable resistor set at 50 Ohms across the two wires of the CQM test lead. Plug the CQM Test lead into the Patient Return Receptacle. The light should turn green. 58. Adjust the variable resistor to increase the resistance until the alarm sounds and the light turns red. Read the variable resistor, it should be between 63 and 77 Ohms.

12

Low Frequency Electrical Safety Test Using a safety capable of testing per IEC 60601-1:2005/(R) 2012 & A1, test low frequency (50 – 60 Hz) as follows: Protective Earth Connection Test (NC) 1. Test from protective earth ground to power entry. 2. Apply 25A of current with safety analyzer. 3. Measure impedance and record it on test form (see test form in the Appendix). Enclosure Leakage Test 1 (NC) 1. Test from protective earth ground to power entry, with ground open. 2. Apply mains voltage. 3. Measure current and record it on test form. Enclosure Leakage Test 2 (NC) 1. Test from protective earth ground to power entry, with reverse polarity and ground open. 2. Apply mains voltage. 3. Measure current and record it on test form. Enclosure Leakage Test 3 (SFC) 1. Test from protective earth ground to power entry, with neutral and ground open. 2. Apply mains voltage. 3. Measure current and record it on test form. Enclosure Leakage Test 4 (SFC) 1. Test from protective earth ground to power entry, with reverse polarity and neutral and ground open. 2. Apply mains voltage. 3. Measure current and record it on test form. Patient Leakage Test 1. Test from all patient connections to power entry. 2. Apply mains voltage. 3. Measure current and record it on test form.

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Error Codes The Ethicon Megadyne™ ESU is designed to assist the user in identifying failure modes. When specific conditions are met an error code will be shown in the large displays. If any of the following errors are displayed and are not cleared by turning the system off then on, record the error displayed and contact the Ethicon Customer Support Center or your local representative for any customer or technical support. Call 1-877-ETHICON (1-877-384-4266) in the US only. Error Description Explanation Trouble Shooting Code 103

Dosage Error

The software has detected a problem with the High Voltage Power Supply during activation

104

Power On Self Test (POST) Relay

A relay error occured during POST.

105

POST Activation

An activation request was (handswitch or footswitch) was detected during POST.

106

POST CQM

A CQM circuit error occured during POST.

107

POST Stuck Button

A button was detected during POST

108

POST B Plus

An error was detected in the variable power supplyduring POST.

119

Power Control

An output was detectedon the variable power supply that was outside normal operating limits.

120

POST I Plus

Current from the variable power supply that was outside normal operating limits during POST.

121

POST Voltage

Monopolar voltage feedbacck measurement were outside normal operating limits during POST.

122

MP Common Relay

An error was detected in the common monopolar relay during activation.

125

BP Common Relay

An error was detected in the common bipolar relay during activation.

126

BP Relay

An error was detected in the bipolar relay during activation.

127

Primary Relay

An error was detected in the primary relay during activation.

128

MP1 Relay

An error was detected in the monopolar 1 relay during activation.

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Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Unplug all accessories (footswitches and devices and restart generator and if error persists return generator for service. Iferror does not persist check the foot switch or instrument for inadvertent activation and replace as necessary. Restart generator and if error persists return generator for service Ensure no buttons are being depressed and restart generator. If error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service

129

MP2 Relay

An error was detected in the monopolar 2 relay during activation.

130

Current Balance

Monopolar active current did not match return current during activation.

131

Current Stop

Monopolar active current did not match return current during idle state.

132

Current Path

Current was detected in a non active relay during activation.

133

Bplus

An incorrect voltage was detected in the variable power supply during activation.

134

Volatage Ratio

The ratio between the variable power supply and the RF output voltages was outside normal operating limits during activation.

136

PFC Over Current

Current from the 360V DC power supply was outside normal operating limits during activation.

137

Iplus Over Current

Current from the variable power supply was outside normal operating limits during activation.

139

PFC Shutdown

An overheat condition was detected, causing the 360V DC power supply to shutdown.

149

Calibration Coag

An error was detected during coag calibration.

150

Calibration BP

An error was detected during bipolar calibration.

152

Calibration CQM

An error was detected during CQM calibration.

153

Calibration High Z

An open circuit was detected during calibration.

155

Calibration

A check sum error was detected during calibration.

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Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Power down the generator ans allow it to cool for 10 minutes before restarting.If error persists return the generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service Restart generator and if error persists return generator for service

Troubleshooting Troubleshooting - follow the steps in the order listed for the appropriate problem. No output power: 1. Check that the generator power switch is in the “ON” position. 2. Ensure the generator is plugged into a grounded, functioning outlet and that the power cord is securely attached to the receptacle at the rear of the generator. 3. Check the cables and connections to ensure they are intact and securely connected. 4. Ensure the patient return electrode is properly installed and connected to the generator. If the patient return electrode alarm light stays illuminated red, see Patient Return Electrode Alarm Stays On section. if using a MEGA Soft® reusable patient return pad, refer to the instructions for use for additional troubleshooting information. 5. Check that the active accessories are attached. 6. Check to see if the unit is in the “Standby” mode (dashed lines in display) or if the power setting is too low. Adjust the power accordingly. 7. Turn the generator to the “OFF” position and then back to the “ON” position. 8. Replace the accessory devices (i.e. pencil, or footswitch). 9. Check the fuse and replace it if necessary. 10. If the problem is not corrected with the above steps, use a backup generator and return the unit for service. 11. Check to confirm the foot pedal is plugged into the correct port. 12. Check for a short in the footswitch cable. Diminished Power Output: 1. Check all accessories for proper set-up and installation. if using a MEGA Soft® reusable patient return pad, refer to the instructions for use for additional troubleshooting information. Patient Return Electrode Alarm Stays On: 1. Check the return electrode cables to insure that they are securely attached to the pad and generator. 2. Make sure “sticky” pads are securely attached to the patient over a good muscular, vascular area. 3. If the patient return electrode alarm light remains illuminated red, replace the return electrode and/or return electrode cable. 4. If the alarm condition cannot be immediately corrected use a backup generator. Greater than Expected Neuromuscular Stimulation: 1. Discontinue use of active accessories. 2. Check all connections for secure fit before continuing use of the generator. 3. Decrease the power setting or change to COAG 1 or COAG 2 from SPRAY COAG as relevant. 4. If neuromuscular stimulation continues replace the generator with a backup unit. 5. Have qualified service personnel test the generator for abnormal low frequency current leakage. 6. If excessive low frequency current leakage is detected return for service. Monitor Interference: Monitor interference can be an artifact of Electrosurgery. Steps to minimize interference are as follows: 1. Ensure that the ECG electrode is well attached to the patient through proper skin preparation prior to electrode placement. 2. Ensure the electrosurgical cables (active and return) do not cross the cables of the affected equipment. 3. Plug the affected equipment into a separate power outlet. 4. Use the lowest possible power setting to achieve the desired effect. 5. Interference is usually greatest in the SPRAY COAG mode; it can be reduced by using a lower voltage mode such as COAG 1 or COAG 2. 6. Check all connections to the generator, patient return electrode, and accessories. 7. Some manufacturers of ECG electrodes offer RF (radio frequency) choke filters for use in the monitor leads. These filters reduce interference while the generator is activated. RF filters minimize the potential for an electrosurgical burn at the site of the monitor electrode.

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Technical Specifications Equipment Classification Equipment Type

IEC 60601-1 Class I IEC 60601-1 Edition 3.1 Type CF

Degree of protection against ingress of water

UL 60601-1 IEC 60601-2-2 Edition 6 IP68 Isolated from Earth Ground Natural Convection, Modulated Internal Fans

Ingress protection of foot switches Patient Circuit Cooling Physical Characteristics Width 36.8 cm (14.5 inches) Depth 43.9 cm (17.3 inches) Height 17.9 cm (7.1 inches) Weight 7.71 kg (17 lbs) Operating Environment The Ethicon Megadyne ESU is designed and tested to operate within the following environmental parameters: Temperature Range: +10°C (+50°F) to +40°C (+104°F) Humidity Range: 15% to 75% Non-condensing Atmospheric Pressure: 700 hPa (10.2 psi) to 1060 hPa (15.37 psi) Warm-up Requirements If the Ethicon Megadyne™ ESU is stored outside of the above range, allow the unit to stabilize at room temperature for a minimum of one hour before use. Transportation and Storage Environment The Ethicon Megadyne™ ESU is designed and tested for storage within the following environmental parameters. Temperature Range: -40°C (-40°F) to +70°C (+158°F) Humidity Range: 10% to 95%, Condensing Atmospheric Pressure: 500 hPa (7.25 psi) to 1060 hPa (15.37 psi) Audio frequencies GEM Cut, Pure CUT and Blend 840 Hz ± 10% Coag 1, Coag 2 ,and Spray Coag 520 Hz ± 10% Micro and Macro Bipolar 480 Hz ± 10% Alarms Power Limit (One beep) 1980 Hz ± 10% Errors (Two beeps) 1980 Hz ± 10% CQM (Three Beeps) 2550 Hz ± 10% The volume of the CUT, COAG and BIPOLAR active signals can be and adjusted up and down. They have a minimum volume of 40 dB measured from the rear of the ESU at a distance of one meter. The alarm volume is fixed to exceed 65 dB at a distance of one meter per the requirements of IEC 60601-2-2 Edition 6. Type and Rating of Fuses: 2 each F10.0AH/250VAC, Schurter Inc. Type FSF Electrical properties Nominal Operating Voltage: 100 – 240 VAC Nominal Operating Frequency: 50-60 Hz Rated Input Power: 550 W Output Power Variation Output variation as a function of input variation <5%

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Output Power Characteristics

Mode

Power (Watts)

Output Tolerance* (Rated Load)

Rated Load (Ohms)

Maximum Open Circuit Voltage (Vp-p)

Maximum Current (Amps)

Operating Frequency (Rated Load)

Crest Factor Nominal @ (Rated Load)

Monopolar CUT GEM

150

20%

200

860

1.2

400kHz

1.6

Pure Cut

300

20%

300

1500

1.1

400kHz

1.6

Blend Monopolar COAG

200

20%

300

2500

1.0

400kHz

2.5

COAG 1

120

20%

500

5000

1.4

COAG 2

120

20%

500

4900

1.4

Spray

120

20%

500

5800

1.4

SOFT COAG

120

20%

140

470

1.1

400kHz

1.6

Bipolar Micro Macro

80 80

20% 20%

100 100

450 590

1.7 1.7

400kHz 400kHz

1.6 1.6

NC < 300 μA

SFC < 1.0 mA

Enclosure

< 100 μA

< 500 μA

Patient Leakage Current

< 10 μA

< 50 μA

Patient Auxiliary Current d.c.

< 10 μA

< 50 μA

Patient Auxiliary Current a.c.

< 100 μA

< 500 μA

2.5μs Pulse @ 32kHz 2.5μs Pulse @ 30kHz 2.5μs Pulse @ 22kHz

* or 5 watts, whichever is greater. Low Frequency (50 - 60 Hz) Leakage Current Earth Leakage Current general

High Frequency (RF) Leakage Current Monopolar Modes (all settings at the maximum) Patient Return to Ground

<150 mA

Active to Ground

<150 mA

Bipolar Mode (Maximum setting) Each Lead to Ground Power Consumption Maximum mains current Idle Cut Coag Bipolar Power Factor Correction Idle Cut Coag Bipolar

< 63 mA 100-120 VAC 0.3 A 5.0 A 2.4 A 1.3 A

220-240 VAC 0.15 A 2.5 A 1.2 A 0.65 A

0.85 0.99 0.98 0.95

0.70 0.98 0.97 0.93

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6.9 7.1 8.2