ESG-400 ELECTROSURGICAL GENERATOR Instructions March 2017

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Contents List of abbreviations...iii Labels and symbols...4 Important information – Please Read Before Use...6 Intended use...6 Application of high frequency treatment...6 Instruction manual...6 User qualifications...7 Electrosurgical generator compatibility...7 Repair and modification...7 Signal words...7 Dangers, warnings and cautions...8 Legal information...16

Chapter 1 Checking the Package Contents...17 Chapter 2 Nomenclature and Functions...18 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11

Symbols and descriptions...18 Front panel...21 Rear panel...22 Bottom panel...23 All screen...23 Set screen...24 Mode screen...25 Footswitch with two pedals...26 Footswitch with one pedal (optional)...26 Neutral electrode cable “P-cord” (optional)...27 Communication cable 0.25 m (MAJ-1871, optional, this cable is required for the connection with the compatible ultrasonic generator)...27 2.12 Communication cable 10 m (MAJ-1872, optional, this cable is required for the connection with the adapter for the compatible high flow insufflation unit (UHI-2/3))...28 2.13 Adapter for UHI-2/3 (MAJ-1873, optional, this adapter is required for the connection with the compatible high flow insufflation unit (UHI-2/3))...28

Chapter 3 Installation and Connections...30 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8

Flow chart for installation work...30 Installation of electrosurgical generator...31 Connection of peripheral equipment...31 Connection to an AC mains power supply...32 Automatic mist & smoke evacuation system/function (when using the compatible high flow insufflation unit)...33 Connection of footswitch...37 Connection of neutral electrode (for monopolar treatment only)...39 Connection of HF instruments...44

Chapter 4 Inspection...47 4.1 4.2 4.3 4.4

Flow chart for inspection work...48 Inspection of power...48 Inspection of connection between peripheral equipment and the electrosurgical generator...50 Inspection of touch-screen and push buttons...51

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Contents 4.5 4.6 4.7

Inspection of footswitch connection...53 Inspection of alarm function...54 Procedure after inspection...55

Chapter 5 Operation...56 5.1 5.2 5.3 5.4 5.5 5.6

Flow chart for operation work...56 Turn on the electrosurgical generator...57 Automatic mist & smoke evacuation system/function (when using the compatible high flow insufflation unit)...57 Output setting...58 Output of energy...70 Procedure after use...73

Chapter 6 Push Button Functions...75 6.1 6.2 6.3 6.4 6.5

Function list...75 Push button hierarchy list...76 Select procedure...77 Assign footswitch and autostart function...78 Menu...80

Chapter 7 Care, Storage and Disposal...96 7.1 7.2 7.3

Care...96 Storage...97 Disposal...97

Chapter 8 Troubleshooting...99 8.1 8.2 8.3 8.4

Neutral electrode operation...99 Error screen, codes and measures...100 Periodic safety check... 110 Returning the electrosurgical generator for repair... 111

Appendix 112 System chart... 112 Mode characteristics... 114 Output characteristics... 117 Transportation, storage and operating environment...143 Specifications...144 Electromagnetic compatibility (EMC) information...149 Alarm information...153 Tone information...154

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List of abbreviations AC EMC ESG FSM HF HPCS ICD IED RCAP UDI

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Alternating Current Electromagnetic Compatibility Electrosurgical Generator Fast Spark Monitor High Frequency High Power Cut Support Implanted Cardioverter Defibrillator Implanted Electronic Device Resistance Controlled Automatic Power Unique Device Identifier

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Important information – Please read before use

Labels and symbols Safety related labels are attached on the housing of the ESG-400. If labels or symbols are missing or illegible, contact Olympus. Function-related symbols are described in chapter “2.1 Symbols and descriptions”.

1. 2. 3. 4.

Caution, read instructions Defibrillation proof type CF applied part (cardiac application) UDI (unique device identifier) Output insulated from earth (connection for neutral electrode)

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LINK-IN

LINK-OUT

1. Non-ionizing electromagnetic radiation 2. Type plate 3. Date of manufacture 4. CE marking 5. Potential equalization terminal 6. Refer to instructions 7. Fuse rating 8. Manufacturer 9. cTUVus marking 10. Waste electrical and electronic equipment

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Important information – Please read before use

Important information – Please Read Before Use Intended use The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment. Contraindications: Electrosurgical interventions are contraindicated if, in the judgment of the physician, tissue coagulation and cutting could have a negative effect on the state of the patient. Electrosurgical tissue coagulation and cutting may be contraindicated for patients with cardiac pacemakers, a weakened immune system or blood coagulation disorders.

Application of high frequency treatment If there is an official standard on the applicability of high frequency treatment as defined by a national or local medical administration, or other institution, such as an academic society, follow that standard when performing the procedure. Before performing any high frequency treatment, study the properties, purposes, effects and possible risks thoroughly (nature, extent, probability and imminence) associated with the planned treatment and any alternative therapeutic method that can be performed. Carry out high frequency treatment only when its benefits outweigh its risks. Fully explain to the patient the possible benefits and risks of high frequency treatment as well as those of any therapeutic method(s) that can be performed instead of electrosurgery, and perform high frequency treatment only after patient consent is granted. During high frequency treatment, continue to evaluate the potential benefits and risks, and stop the treatment if the risks become greater than the possible benefits to the patient.

Instruction manual This instruction manual contains essential information on using this electrosurgical generator safely and effectively. Before use, thoroughly review this instruction manual and the instruction manual of all equipment which will be used during the procedure. Use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this instruction manual, please contact Olympus.

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User qualifications If there is an official standard that defines the qualifications required for medical personnel using electrosurgical generators as defined by a national or local medical administration or other institution, such as an academic society, follow this standard. If there is no such standard, the user must be a physician or medical personnel under supervision of a physician and must have received appropriate training in using this electrosurgical generator. This instruction manual, therefore, does not explain or discuss endoscopic or electrosurgical procedures. In addition, the user must undergo an instruction / training for the use of this electrosurgical generator. The instruction / training will be provided by authorised representatives of Olympus during installation and commissioning. Federal Law of the USA restricts this device to use by, or on the order of, a physician.

Electrosurgical generator compatibility Refer to the “System chart” and “Specifications” in the Appendix to confirm that this electrosurgical generator is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and / or equipment damage. For the electromagnetic compatibility (EMC), this electrosurgical generator complies with IEC 60601-1-2.

Repair and modification This electrosurgical generator does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or user injury and / or equipment damage may result. Repairs must only be carried out by Olympus or a firm authorised by Olympus. Some problems that appear to be malfunctions may be corrected by referring to “Chapter 8 Troubleshooting”. If the problem cannot be resolved using the information in this chapter, contact Olympus.

Signal words The following signal words are used throughout this instruction manual: DANGER Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

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Important information – Please read before use

CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. NOTE

Indicates additional helpful information.

Dangers, warnings and cautions High frequency leakage current or spark discharge may cause user and / or patient burns. Always prepare for an emergency operation in case of unintentional patient burn, bleeding and perforation. Follow the dangers, warnings and cautions given below when handling this electrosurgical generator. This information is to be supplemented by the dangers, warnings and cautions given in each chapter.

User-related error prevention WARNING

Improper use •• The safety and effectiveness of electrosurgical interventions depend not only on the design of the equipment used, but also to a major extent on factors which are under the control of the user. It is therefore extremely important to read, understand and follow the instructions supplied with the electrosurgical generator and the accessories in order to ensure safety and effectiveness. •• Always use the electrosurgical generator as outlined in this instruction manual. Improper use will not only impede functions and prevent optimum performance, but may cause equipment damage and / or complications. Before each use, always inspect the equipment as outlined in this instruction manual.

WARNING

Unauthorized repairs and product modification There is a risk of injury to the patient and/or the user caused by unauthorized repairs and product modification. •• Do not attempt to repair or modify the product.

CAUTION

Annual safety checks The electrosurgical generator and the footswitch must undergo a safety check in yearly intervals in accordance with the national statutory regulations (refer to chapter “8.3 Periodic safety check”).

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Environmental conditions CAUTION

Interference with other equipment •• Be sure that this electrosurgical generator is not used adjacent to or stacked with other equipment (other than the components of this electrosurgical generator or system) to avoid electromagnetic interference. •• Before use, thoroughly confirm the compatibility of all equipment. •• To ensure electrical safety, the electrosurgical generator should not be used in conjunction with: -- Electrical equipment whose safety leakage current is not guaranteed. -- Electrosurgical equipment whose combined use is not guaranteed.

against

safety

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•• The electrosurgical generator complies with the electromagnetic compatibility (EMC) standard. Nevertheless, when the electrosurgical generator is active it may disturb neighboring electronic equipment. If an auxiliary computer system is in use together with the electrosurgical generator and endoscopic imaging techniques, the image on the monitor might freeze or blackout. Follow the instructions in “Electromagnetic compatibility (EMC) information” in the Appendix regarding electromagnetic ambient conditions. •• Never loop the cords (active cord, bipolar cord, neutral electrode cord) or bundle cords together with cords belonging to other medical equipment. The high frequency signals or spark discharge noise generated by the electrosurgical generator may interfere with the operation of other medical equipment. •• Do not use the electrosurgical generator in a location exposed to strong electromagnetic radiation (microwave or short-wave medical treatment equipment, magnetic resonance imaging, radio or mobile phone equipment). Electrosurgical generator malfunction can occur. CAUTION

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Unsuitable temperature and humidity The electrosurgical generator should only be used under the conditions as described in the section “Transportation, storage and operating environment” in the Appendix. Use under other conditions may impede normal performance and / or result in equipment damage.

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Accessories WARNING

Mechanical stress Do not apply excessive bending, straining, or squeezing force to any cords. It may cause malfunction.

CAUTION

Damaged and non-compatible accessories •• The electrosurgical generator shall only be used with compatible accessories. When connecting accessories (cords, electrodes, HF instruments) avoid output settings where the maximum output voltage of the electrosurgical generator may exceed the rated accessory voltage (refer to “Mode characteristics”, “Output characteristics” in the Appendix, and the instruction manual of the accessory). For a list of compatible neutral electrodes refer to “Specifications” in the Appendix. For compatible plugs and sockets refer to chapter “3.8 Connection of HF instruments”. •• Before use, the electrosurgical generator and accessories must be examined for damage. All cables and its plugs must be free of scratches and cracks. Cables and accessories with damaged insulation or connections must not be used.

Electric shock WARNING

Grounding failure To prevent the risk of electric shock, the housing of the electrosurgical generator must be grounded. Always connect the power cord plug to a properly grounded wall outlet. Do not use a 3-pin / 2-pin adapter, as it can impair safe operation of the electrosurgical generator.

WARNING

User shock To prevent user shock, malfunction and damage of the electrosurgical generator, keep liquids away from all electrical equipment. If liquid gets on or into the electrosurgical generator, terminate operation immediately and contact Olympus.

CAUTION

Injury during servicing When the housing is opened, there is a danger of electric shock. The electrosurgical generator must only be serviced by authorized technicians.

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Burns WARNING

Patient and / or user •• The maximum output voltage characteristics of the electrosurgical generator are shown in the diagrams in “Output characteristics” in the Appendix. When setting the power level, first set it to a low level and increase it gradually. If the output is initially set to a high level, the electrode’s insulation may be damaged and cause user and / or patient burns. However, certain modes may present an unacceptable risk at low output power settings. For example, with the PulseCut fast mode or PulseCut slow mode, the risk of an excessive thermal effect rises if the output power setting is too low. Therefore, it is recommended that you perform basic testing before using the electrosurgical generator. If the instruction manual of the HF instrument to be used stipulate a rated voltage, the output should be set so that it does not exceed that voltage. •• Contact with the tip of the electrodes may cause burns when the electrosurgical generator is active. •• During operation, temporarily unused electrodes should be stored in an electrically insulated container. Unused electrodes or HF instruments should never be placed on the patient. Otherwise, it may cause patient and / or user burns. •• To prevent patient burns, the electrosurgical generator and ancillary cords should not come in contact with the patient or metal parts of the operating table. Furthermore, the patient should also be kept away from metallic parts of the operating table or other devices. Remove any metallic items from the patient (wristwatches, jewelry, etc.) before starting the procedure. •• If the electrosurgical generator is used in conjunction with another electrosurgical generator, never use both generators simultaneously. Keep the HF instrument connected to the not-used electrosurgical generator away from the target area while the other generator is in operation. Do not activate output of both generators simultaneously. Patient or user injury may occur due to the concentration of electric current. •• To prevent patient burns, the patient’s skin surfaces should not touch each other (e.g. bare arm and side of chest) or any metal items in the procedure room. •• To prevent patient burns during high frequency treatment, the patient’s clothes must be dry.

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Important information – Please read before use

•• During endoscopic treatment be sure that the distal end of the endoscope and / or HF instruments do / does not contact bridging fluids surrounding the target tissue. Electric current may flow to the surrounding tissue via the fluids and cause burns. This does not apply to instruments intended for use in conjunction with conductive fluids. •• The endoscopic treatment performed should not include an operation in which part of the treated tissue (polyp head, etc.) or part of the endoscope distal end or endotherapy instrument is in contact with or close to surrounding tissue during high frequency exposure. Otherwise, current flows to the tissue through the part of the treated tissue, the metallic parts at the endoscope’s distal end or endotherapy instrument and may cause burns. •• When using an electrocardiograph or other physiological monitoring equipment simultaneously with the electrosurgical generator on a patient, any monitoring electrodes should be placed as far away as possible from the electrodes used with the electrosurgical generator. If placed too close, high frequency signals or spark discharge noise from the electrosurgical generator may interfere with the operation of an electrocardiograph or other physiological monitoring equipment. Needle monitoring electrodes should not be used, as they may cause patient burns. Physiological monitoring equipment incorporating high frequency current limiting measures is recommended. •• To prevent burns, the user and assistant should wear surgical gloves during the procedure. CAUTION

High frequency leakage current Wherever possible, the patient should not be able to come into contact with electrically conductive components that are grounded. Route all connecting cables so that they are not in direct contact with the patient or other cables. Capacitive coupling may occur.

Potential hazards for the heart DANGER

Shock hazards to the heart •• To prevent shock hazards, never apply the electrosurgical generator to the heart in combination with type B or BF applied parts. •• When using the electrosurgical generator on or in the vicinity of the heart, be sure to use it with the minimum necessary output. Spark discharge during operation may affect the heart.

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DANGER

Pacemaker / Defibrillator malfunction The high frequency equipment, when applied to a patient with a cardiac pacemaker, an implanted cardioverter defibrillator (ICD) or other implanted electronic devices (IED), may cause malfunctioning or failure of the implanted electronic device and may seriously affect the patient. Always confirm that it is safe to proceed with a cardiologist or the manufacturer of the implanted electronic device before proceeding. If monopolar modes of the electrosurgical generator are used, position the neutral electrode so that the current pathway does not pass through or near the implanted electronic device and its lead system. The risk of malfunction or failure of an implanted electronic device is reduced by the use of a bipolar mode. A risk does exist, however, if the application is in close proximity to the implanted electronic device.

WARNING

Cardiac emergency Always keep a defibrillator ready in case of a cardiac emergency. During operation of the defibrillator, remove the endoscope and / or laparoscope and HF instruments from the patient.

WARNING

Ignitable gases in the bladder Electrolysis that occurs during TCR/is (Transcervical endometrial Resection) and TURis (Transurethral Resection) can produce flammable gases. These gases can ascend into the upper part of the uterus or bladder and can come in contact with the electrode. Activating the HF current while flammable gases are present can cause the gases to ignite or explode. This can result in uterine or bladder perforation or puncture, exogenous burns or other injury.

Fire / Explosion

•• Before activating the HF current, use the endoscopic image to make sure that the distal end of the resectoscope is not located in the flammable gases. The gases are visible as bubbles in the irrigation fluid. •• Do not activate the HF current while the distal end of the resectoscope is located in the gases or in their direct vicinity. •• Before activating the HF current, evacuate or move the gases or allow the gases to escape from the uterus or bladder as necessary, e.g. by evacuating the gases through the sheath of the resectoscope.

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Important information – Please read before use

DANGER

Ignitable anaesthetics and gases The risk of flammable gases or other materials being ignited exists with any surgical application of electrical energy. Precautionary measures must be taken to keep flammable materials and substances away from the site of intervention (do not use flammable anaesthetics, nitrous oxide or oxygen). Otherwise, explosion or fire may result and cause serious injuries. This electrosurgical generator is not explosion-proof. Do not use the electrosurgical generator within an explosion zone.

WARNING

Ignitable gas in the gastro-intestinal tract If the intestines contain a flammable gas, replace this gas with air or a non-flammable gas before performing the operation, to minimize the risk of fire or explosion.

WARNING

Ignitable cleaning- and disinfection agents •• Flammable agents used for cleaning and disinfection must be allowed to evaporate before the electrosurgical generator is used. Also ensure that flammable solutions are neither on the patient’s skin (e.g. under neutral electrode) nor in the patient’s body cavity when the electrosurgical generator is used. •• Non-flammable agents should be used for cleaning and disinfection wherever possible.

WARNING

Ignitable materials •• If absorbent cotton or gauze is used during the procedure, it can be ignited by a spark generated in the normal operation of the equipment. •• When performing electrosurgery, sparks occur which could lead to burning or deflagration of combustible materials. •• Body hair is flammable. Water soluble surgical lubricating jelly may be used to cover hair close to the surgical site to decrease flammability.

WARNING

Risk of fire Disconnect the power plug before changing the fuses! Replace fuses as marked. The fuses must only be replaced by authorized technicians!

Procedural hazards and complications DANGER

Procedural hazards and complications •• The safety of electrosurgery will be greatly enhanced by a thorough knowledge of the medical literature on the subject. Study of specific information on the hazards and complications of the procedure in question is especially recommended.

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•• To respond to possible patient bleeding, prepare at least one of the following three haemostatic procedures: coagulation, clipping or local injection. •• To prepare for possible accidents, emergency equipment for life-saving, intubation and appropriate pharmaceuticals should be located in or near the procedure room. •• Always prepare a spare electrosurgical generator or an alternative procedure to avoid interruption of treatment due to an unexpected electrosurgical generator failure during treatment. •• Should any abnormal output be suspected during operation, immediately terminate the use of the equipment by releasing the footswitch. If the footswitch does not react, switch off the electrosurgical generator. Otherwise, malfunction of the equipment may cause an unintended increase in output. •• Use physiological monitoring equipment throughout the entire procedure, for continuous observation of the patient’s condition. •• For procedures where the high frequency electrical current could flow through parts of the body with a relatively small cross sectional area, the use of a bipolar mode may be desirable in order to avoid unwanted tissue damage. •• It is not recommended to use electrosurgery for circumcisions because of the risk of thermal injuries. The risk can be reduced if metal parts of any kind (e.g. clamps) and / or monopolar HF instruments are avoided. WARNING

Safety measures during the procedure •• Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. During operation, wear appropriate personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and surgical gloves that fit properly and are long enough so that your skin is not exposed. •• Studies have shown that smoke generated during electrosurgical procedures can be irritating and potentially harmful to surgical personnel. These studies recommend the use of surgical masks and adequate ventilation of smoke by the use of surgical smoke evacuators or other means.

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Important information – Please read before use

WARNING

Output performance •• If the electrosurgical generator fails and the output is stopped during treatment, it may be impossible to continue treatment due to tissue or coagulum build‑up on the HF instrument or other similar condition. •• During endoscopic treatment never grasp the target tissue with non-insulated grasping forceps. Noninsulated grasping forceps will disperse the electric current and normal operation may be impeded.

WARNING

Electrical stimulation of nerves and muscles Nerves and muscles can be stimulated by low frequency electrical currents or intense high frequency electrical currents. Low frequency electrical currents may be generated by a partial rectification of intense high frequency electrical current, in particular when there is a spark discharge to the tissue or to another metallic object. Intense high frequency electrical currents can occur at the beginning of an electrosurgical cut or when using high output power settings. This may cause violent spasms or muscle contractions. Use the lowest appropriate power level and effect (e.g. effect 1 instead of effect 3). However, for certain modes a low output power setting may present an unacceptable risk for the patient. For example, with the PulseCut fast mode or PulseCut slow mode, the risk of an excessive thermal effect rises if the output power setting is too low.

CAUTION

Generator defect •• To prevent electrosurgical generator damage, never short-circuit electrodes (accessories, neutral electrodes). •• In the event of a defect or malfunction in the electrosurgical generator, an undesirably high output power may be emitted.

Legal information Olympus, RFCoag, ESG, RCAP and AFU are trademarks or registered trademarks of Olympus Corporation, Olympus Medical Systems Corporation and / or their affiliates, in the US and / or other countries. Ricoh TrueType and Bitmap fonts designed by RICOH Company, Ltd. are used.

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Chapter 1 Checking the Package Contents Verify that all items shown below are contained in the package. Inspect each item for damage. If the electrosurgical generator is damaged, a component is missing or you have any questions, do not use the electrosurgical generator and contact Olympus.

1. Electrosurgical generator (ESG-400) 2. Footswitch with cable (WB50402W) 3. Instruction manual

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Chapter 2 Nomenclature and Functions

Chapter 2 Nomenclature and Functions 2.1 Symbols and descriptions  Front panel Power on / off Neutral electrode – non-split type Neutral electrode – split type Select procedure Footswitch Menu BIPOLAR socket MONOPOLAR 1 socket UNIVERSAL socket MONOPOLAR 2 socket

 Touch-screen Double footswitch Single footswitch Autostart Plus Minus Return OK Cancel Save procedure Delete procedure Languages Touch tone on

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Touch tone off Software version Safety test Service Volume Brightness Select procedure (in title line) Menu (in title line) Toggle Previous Next Numeric Alphabetic Uppercase / lowercase Backspace Caution Communication indicator Reset Resistance Controlled Automatic Power Reference to BIPOLAR socket Reference to MONOPOLAR 1 socket Reference to UNIVERSAL socket Reference to MONOPOLAR 2 socket

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