ESG-150 ELECTROSURGICAL GENERATOR Instructions for Use Nov 2018

Contents 1 General information...7 1.1 User instructions...7 1.2 Signal words...7 1.3 Conventions throughout this document...7 1.4 List of abbreviations...8 1.5 Manufacturer...8 1.6 Reporting serious incidents...8 2 Safety information...9 2.1 Intended use...9 2.2 Contraindications...9 2.3 User qualification...9 2.4 Environment of use...9 2.5 General dangers, warnings and cautions...9 2.5.1 Potential hazard to the heart...10 2.5.2 Risks regarding accessories...10 2.5.3 Risk regarding electric shock...11 2.5.4 Risks regarding burns...11 2.5.5 Risks regarding fire and explosion...12 2.5.6 Procedural hazards and complications...12 2.5.7 User-related error prevention...13 2.5.8 Risk regarding environmental conditions...13 3 Product description...14 3.1 General operating principles of the ESG‑150...14 3.2 Scope of delivery...14 3.3 Hardware...15 3.3.1 The front panel...15 3.3.2 The back panel...16 3.3.3 The double pedal foot switch...17 3.4 Touchscreen...18 3.4.1 Home screen at “Advanced User Level”...18 3.4.2 Home screen at “Basic User Level”...19 3.4.3 Drop-down menus for mode selection...22 3.4.4 The screen [Main Menu]...22 3.5 Software features...23 3.5.1 CQM – Contact Quality Monitoring for the neutral electrode...24 3.5.2 HPCS – High Power Cut Support...24 3.5.3 FSM – Fast Spark Monitor...24 3.6 Symbols on the product...24 3.7 Warranty...25 4 Installation...26 4.1 General inspection...26 4.2 Placement of the electrosurgical generator...26 4.3 Connecting the electrosurgical generator to the mains electricity...26 4.3.1 Before connecting...27 4.3.2 Connecting...27 4.4 Connecting the foot switch...27 4.4.1 Before connecting...28 4.4.2 Connecting...28

5 System settings...29 5.1 Operation of the touchscreen...29 5.2 User level...29 5.2.1 Advanced User Level...29 5.2.2 Basic User Level...30 5.2.3 Selecting the user level...30 5.3 Volume control of output tones...30 5.4 Brightness control...31 5.5 Touch Tone...31 5.6 Date/Time...31 5.7 Languages...32 5.8 User-defined settings...32 6 Operating the ESG‑150 with a neutral electrode...34 6.1 Safety information for neutral electrode operation...34 6.2 Split type and non-split type neutral electrodes and CQM...34 6.3 Conditions of the CQM indicator...35 6.4 Correct usage of neutral electrodes...36 6.5 Connecting a neutral electrode to the electrosurgical generator...37 6.5.1 Connecting a neutral electrode with a pre-attached cable...37 6.5.2 Connecting a neutral electrode without a pre-attached cable...38 6.6 Verifying the CQM indicator...38 7 Inspection before operation...39 7.1 Safety information for inspection before operation...39 7.2 Inspection regarding reprocessing...39 7.3 Inspecting the supply of power...39 7.4 Inspecting the touchscreen...39 7.5 Inspecting the foot switch connection...40 7.6 Inspecting the alarm system...40 8 Power settings...41 8.1 Overview of modes...41 8.2 Description of modes...41 8.2.1 Description of the monopolar modes...41 8.2.2 Description of the bipolar modes...42 8.2.3 Predefined values for combined power/effect at Basic User Level...43 8.3 Tissue effects depending on the power level and effect level...44 8.3.1 Monopolar modes...44 8.3.2 Bipolar modes...44 8.4 Selecting the appropriate output settings...45 8.4.1 Selecting the mode...45 8.4.2 Advanced User Level - Selecting the power level...46 8.4.3 Advanced User Level - Selecting the effect level...46 8.4.4 Basic User Level - Selecting the combined power/effect level...46 8.4.5 Selecting a user-defined setting...46 9 Connecting HF instruments...47 9.1 Safety information for connecting HF instruments...47 9.2 Description of the output sockets...47 9.3 Connecting...48 10 Operation...49 10.1 Safety information for operation...49 10.2 Activating...50 10.2.1 Before activating...50

10.2.2 Limited activation time...50 10.2.3 Functional principles of activating HF current...50 11 Alarm system...53 11.1 The alarm system...53 11.2 Additional information on the alarm system...53 11.3 Error messages...54 12 Troubleshooting...55 12.1 General problems...55 12.2 Overview of error messages...57 13 After use...61 13.1 Disconnecting...61 13.2 Reprocessing...61 13.2.1 General information for reprocessing...61 13.2.2 Cleaning...62 13.2.3 Disinfection...63 13.2.4 Other HF equipment...63 14 Maintenance, repair and shipment...64 14.1 Annual safety check...64 14.2 Repair...64 14.3 Shipment...64 15 Storage and disposal...65 15.1 Storage...65 15.2 Disposal...65 16 Compatible equipment...66 16.1 System chart...66 16.2 Compatible neutral electrodes...67 17 Technical data...69 17.1 Specifications for the ESG‑150...69 17.2 Specifications for the double pedal foot switch...70 17.3 Specifications for the power cables...70 18 Additional information...71 18.1 Alarm system...71 18.2 Alarm tones...71 18.3 Output tone information...72 18.4 Mode characteristics according to IEC 60601-2-2...72 18.5 Characteristics of High Power Cut Support (HPCS)...72 18.6 Output characteristic diagrams...72 18.6.1 Monopolar modes...74 18.6.2 Bipolar modes...79 19 Electromagnetic compatibility...81

Figures Figure 3.1 Front panel of the ESG‑150...15 Figure 3.2 Back panel of the ESG‑150...16 Figure 3.3 Double pedal foot switch...17 Figure 3.4 Cable inlet on the back of the foot switch...17 Figure 3.5 Buttons on the home screen at “Advanced User Level”...18 Figure 3.6 Indicators and displays on the home screen...19 Figure 3.7 Buttons on the home screen at “Basic User Level”...20 Figure 3.8 Indicators and displays on the home screen...21 Figure 3.9 Drop-down menu [Select Cut Mode] for monopolar cutting...22 Figure 3.10 Edit user-defined settings and system settings...23 Figure 4.1 Connecting the power cable to the electrosurgical generator...27 Figure 4.2 Connecting the foot switch to the electrosurgical generator...28 Figure 5.1 Advanced User Level - separate buttons for power and effect...29 Figure 5.2 Basic User Level - one button for combined power/effect level...30 Figure 6.1 Error message “Insufficient neutral electrode contact”...35 Figure 6.2 Message box “Non-split type neutral electrode detected”...35 Figure 6.3 Connecting the plug of the neutral electrode...37 Figure 6.4 Fixing the neural electrode to the connecting cable...38 Figure 8.1 Exemplary values for combined power and effect...43 Figure 9.1 CAUTION - No connection of 2-pin plugs...47 Figure 9.2 MONOPOLAR socket specifications...48 Figure 9.3 BIPOLAR socket specifications ...48 Figure 10.1 Activation screen for PureCut mode...51 Figure 10.2 Activation screen for PulseCut mode...51 Figure 10.3 Coagulation screen during activation...52 Figure 11.1 Error message “E0202 Insufficient neutral electrode contact”...54 Figure 16.1 System chart...66 Figure 18.1 Characteristics of HPCS...72

Tables Table 8.1 Table 8.2 Table 8.3 Table 11.1 Table 12.1 Table 12.2 Table 16.1 Table 16.2 Table 18.1 Table 18.2

Modes...41 Tissue effects for monopolar modes...44 Tissue effects for bipolar modes...45 Meaning of alarm priorities...53 Troubleshooting...57 Overview of error messages...60 Compatible equipment...67 Compatible neutral electrodes...68 Output tone information for modes...72 Color legend for output characteristic diagrams...73

General information

1 General information 1.1 User instructions •• Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure. •• If the required instructions for use are missing, immediately contact an Olympus representative. •• Keep the instructions for use in a safe, accessible location.

1.2 Signal words The following signal words are used throughout this document. WARNING Indicates a potentially hazardous situation which, if not avoided, can result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, can result in minor or moderate injury. NOTICE Indicates a property damage message.

1.3 Conventions throughout this document This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. Observe all safety messages that follow this symbol to avoid possible injury. This symbol indicates additional helpful information. 1. A numeration indicates a sequence of actions. 2. 3. • Bullet points indicate individual actions or different options for action. - Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations. 2) 3) […] Bracketed terms refer to elements in the graphical user interface or keys. Elements in the graphical user interface can be: - buttons - menu items - dialog elements

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General information

1.4 List of abbreviations CQM DGHM EPA EMC ESD ESG FDA FSM GSM HF HPCS UDI

Contact Quality Monitor Deutsche Gesellschaft für Hygiene und Mikrobiologie Environmental Protection Agency Electromagnetic compatibility Electrostatic discharge Electrosurgical generator Food and Drug Administration Fast Spark Monitor Global system for mobile communication High frequency High Power Cut Support Unique device identifier

1.5 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

1.6 Reporting serious incidents If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority.

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Safety information

2 Safety information 2.1 Intended use The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulating tissue in endoscopic surgery.

2.2 Contraindications Absolute contraindications There are no absolute contraindications. Relative contraindications In general, electrosurgical procedures are contraindicated under the following circumstances: -- If tissue coagulation and cutting can have a negative effect on the state of the patient. -- For patients with implanted electronic devices, e.g. cardiac pacemaker, cardioverter defibrillators. -- For patients with a weakened immune system. -- For patients with blood coagulation disorders.

2.3 User qualification Medical use This product is only intended to be used by a qualified physician or by qualified medical personnel under supervision of a physician. These instructions for use do not explain or discuss clinical procedures. Repair Repair of the product may only be performed by qualified servicing personnel that has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the safety and performance of the product.

2.4 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms or equivalent with appropriate specialized equipment.

2.5 General dangers, warnings and cautions The following warnings and cautions apply to the general handling of the product. This information is to be supplemented by the dangers, warnings and cautions given in each chapter in this document or in the instructions for use of any product being used with this product.

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Safety information

2.5.1 Potential hazard to the heart WARNING Malfunction of pacemakers and defibrillators Using HF equipment on patients with implanted electronic devices, e.g. cardiac pacemakers or cardioverter defibrillators, can cause failure of the implanted electronic device. Failure of the implanted electronic device will affect the heart and can result in cardiac arrest. •• Before the HF procedure, confirm its safety with a cardiologist or the manufacturer of the implanted electronic device. •• For monopolar procedures, position the neutral electrode so that the current pathway does not pass through or near the implanted electronic device and its lead system. •• Do not apply the HF instrument in close proximity to the implanted electronic device. 2.5.2 Risks regarding accessories WARNING Incompatible equipment Using incompatible equipment can lead to excessive or incorrect energy output. This can result in injury to the patient and the user as well as damage to the product. •• Only use this electrosurgical generator with compatible equipment. •• Refer to the chapter “16 Compatible equipment” on page 66. WARNING Damaged equipment and accessories The use of damaged equipment, of equipment with improper functioning or the reuse of single use products can cause electric shock, mechanical injury, infection and thermal injury to the patient and the user. •• Before each use, observe the instructions in the chapter “7 Inspection before operation” on page 39 •• Do not use damaged equipment or equipment with improper functioning. •• Do not reuse used accessories that are intended for single use. •• Replace damaged equipment or equipment with improper functioning. WARNING Mechanical injuries by snares Mechanical stress at the treatment site when using a snare can result in bleeding and perforation to the patient. •• Select a wire diameter of the snare that is appropriate for the target tissue. •• As long as HF current is not activated, only close the snare loosely around the target tissue. •• Before closing the snare for cutting, make sure to activate the HF current. WARNING Connecting accessories Connecting accessories while the electrosurgical generator is switched on can result in injury and electric shock to the patient, the user and/or the medical personnel. •• Ensure that the electrosurgical generator is switched off before connecting accessories. CAUTION Risk of sparkover There is a risk of sparkover leading to electrical injury, thermal injury and/or unintended nerve stimulation to the patient. •• Check the maximum rated voltage of the other HF equipment.

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Safety information

•• Make sure that the maximum output voltage of the electrosurgical generator does not exceed the lowest maximum rated voltage of any of the HF equipment used during the procedure. 2.5.3 Risk regarding electric shock WARNING Grounding failure There is a risk of electric shock if the housing of the electrosurgical generator is not grounded. •• Only connect the power cable to a properly grounded fixed socket outlet. •• Do not use an adapter for an incompatible grounded fixed socket outlet as it can impair safe operation of the electrosurgical generator. 2.5.4 Risks regarding burns WARNING Power levels and activation time The selected power level and the activation time should be as low as possible for the intended purpose. If the power level initially is set too high or if the activation time is too long, then this can result in thermal injury to surrounding tissue, bleeding or inadequate treatment. •• For appropriate power levels, refer to the section “8.4 Selecting the appropriate output settings” on page 45. •• Before the procedure, perform basic testing with the electrosurgical generator. WARNING Unintended tissue contact When the output of the electrosurgical generator is active, then unintended contact between tissue and the active part of the HF instrument can cause burns to the patient, the user and the medical personnel. •• Store temporarily unused HF instruments in an electrically insulated container. •• Do not place unused HF instruments on the patient. CAUTION Unintended current flow and HF leakage current Unintended current flow and HF leakage current can cause thermal injury to the patient. The patient must be insulated against all electrically conductive parts. •• Ground the operating table. •• Make sure that the patient does not come in contact with metal parts, e.g. the operating table. •• Place the patient on a dry, electrically insulating surface. •• Make sure that the patient’s clothes are dry. •• Prevent any contact between different skin surfaces (arms, legs) of the patient. Place dry gauze between the body and arms and between the legs to prevent such contact. •• Prevent any skin contact between the patient and the user. •• Remove any metallic items from the patient, e.g. wristwatches, jewelry. •• Route all connecting cables so that they are not in direct contact with the patient. •• Route all connecting cables so that they are not in contact with other cables.

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Safety information

2.5.5 Risks regarding fire and explosion WARNING Flammable gas in the gastrointestinal tract Flammable gases within the intestines of the patient can cause fire or explosion when applying HF current. This will result in serious injury to the patient. •• Before the HF procedure, replace intestine gases by non-flammable gases. WARNING Flammable anaesthetics and gases If flammable gases, especially anaesthetics ignite, then they cause serious injuries to the patient, the user and the medical personnel. •• Take precautionary measures to keep away flammable gases from the site of intervention. •• Do not use flammable anaesthetics. WARNING Flammable materials Sparks that occur during normal operation of the HF equipment can ignite flammable materials, e.g. absorbent cotton or gauze and also body hair. This can result in serious injuries to the patient, the user and the medical personnel. •• Use soluble surgical lubricating jelly to cover hair close to the site of intervention. •• Do not apply materials like cotton or gauze simultaneously with the HF instrument to the site of intervention. 2.5.6 Procedural hazards and complications WARNING Impeded performance Coagulum or eschar that accumulates at the HF instrument can impede the performance of the electrosurgical generator. Increasing the power level can damage the electrosurgical generator and can result in injury to the patient. •• Carefully clean affected areas of the HF instrument. Refer to the instructions for use of the HF instrument. •• If necessary, replace the HF instrument. WARNING Electrical stimulation of nerves and muscles Low frequency electrical currents or intense high frequency electrical currents can stimulate nerves and muscles which can result in violent spasms or muscle contractions of the patient. Low frequency electrical currents can 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 power levels. •• Use the lowest appropriate power level and effect level. •• For appropriate power levels, refer to the section “8.4 Selecting the appropriate output settings” on page 45. WARNING Electrosurgical smoke Electrosurgical interventions produce smoke. When unfiltered smoke is inhaled, then this can affect the health of the user and the medical personnel. •• Wear high-filtration masks during the procedure. •• Make sure that a surgical smoke evacuator is used for the procedure. •• Make sure that adequate ventilation is provided.

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Safety information

CAUTION Procedural hazards and complications If a malfunction of the electrosurgical generator occurs during the procedure, there is the risk that the procedure is interrupted, delayed or cannot be completed. •• Before starting the procedure, check that all equipment is connected properly. •• Observe the instructions in the chapter “7 Inspection before operation” on page 39 •• Prepare a spare electrosurgical generator or an alternative procedure to avoid interruption due to an unexpected electrosurgical generator failure during the procedure. 2.5.7 User-related error prevention CAUTION Annual safety checks To maintain device performance and electrical safety, annual safety checks must be performed on the electrosurgical generator and the foot switch. Otherwise, malfunction of the devices can occur which can result in injury to the patient. •• Make sure that the annual safety check is performed regularly. •• Observe the information in the section “14.1 Annual safety check” on page 64. Observe national statutory regulations. 2.5.8 Risk regarding environmental conditions CAUTION The electrosurgical generator can disturb other equipment The electrosurgical generator complies with the standards as described in the chapter “19 Electromagnetic compatibility” on page 81. However, during activation, high frequency signals or spark discharge noise generated by the electrosurgical generator can disturb neighboring electrical equipment. Malfunction of the devices can occur, e.g. the monitor of endoscopic imaging equipment can freeze or black out, which can result in injury to the patient. •• Follow the instructions regarding electromagnetic ambient conditions given in the chapter “19 Electromagnetic compatibility” on page 81. •• Make sure that electrosurgical generator is not used adjacent to or stacked with equipment that is not part of this electrosurgical generator or system. •• Before use, thoroughly confirm the compatibility of all equipment. •• Do not use the electrosurgical generator in conjunction with: -- Electrical equipment for which the safety against leakage current is not confirmed. -- Electrosurgical equipment for which the safety in combined use is not confirmed. •• Do not loop cables. •• Do not bundle cables together with cables belonging to other medical equipment.

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Product description

3 Product description 3.1 General operating principles of the ESG‑150 The electrosurgical generator ESG‑150 is designed to be used for the following electrosurgical applications: -- Bipolar electrosurgical cutting and coagulation. -- Monopolar electrosurgical cutting and coagulation, which requires a neutral electrode. The ESG‑150 is equipped with several cutting and coagulation modes which are mainly designed for procedures in the gastrointestinal tract and in the respiratory tract. All settings of the device are selected via the touchscreen on the front panel. The ESG‑150 is activated either via a compatible double pedal foot switch or via a hand switch at the connected HF instrument. The ESG‑150 is connected to the local power supply. Details on the hardware and software, on the correct handling and use of the device are described in the following chapters.

3.2 Scope of delivery •• Before use, check that all items listed below are available. •• Contact an Olympus representative or an authorized service center if any items are missing or damaged. -- Electrosurgical generator ESG-150 -- Footswitch, double pedal -- Instructions for use

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Product description

3.3 Hardware 3.3.1 The front panel

ESG-150

Figure 3.1

Front panel of the ESG‑150

1) Neutral electrode socket* To connect a neutral electrode. 2) BIPOLAR output socket* To connect a bipolar HF instrument. 3) Touchscreen To display the status of connected accessories. To show and modify settings. 4) MONOPOLAR output socket* To connect a monopolar HF instrument. 5) UDI (unique device identifier) 6) Power switch To switch the electrosurgical generator on and off. *Applied part according to standard IEC 60601-1.

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Product description

3.3.2 The back panel

Figure 3.2

Back panel of the ESG‑150

1) Volume control To adjust the volume of the output tone. 2) Ventilation slots 3) Potential equalization connector To increase electrical safety by potential equalization. 4) Symbol plate 5) Power socket with fuse holder For connection to the mains electricity with compartment for the replaceable fuses. 6) Identification plate 7) Foot switch socket To connect a compatible double pedal foot switch.

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Product description

3.3.3 The double pedal foot switch

Figure 3.3

Double pedal foot switch

1) Handle To carry the foot switch properly. 2) Foot switch plug To connect the foot switch to the electrosurgical generator. 3) Coagulation pedal (blue) To activate the selected coagulation mode. 4) Cut pedal (yellow) To activate the selected cutting mode.

WB50402W

Figure 3.4

Cable inlet on the back of the foot switch

Correct handling of the foot switch If the foot switch is handled without care, the cable can get broken at the cable inlet. Observe the following: •• Do not pull on the cable. •• Do not wind the cable around the handle.

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Product description

•• Use the handle for carrying the foot switch. •• Only use the cleaning and disinfection methods as described in the section “13.2 Reprocessing” on page 61. Aggressive reprocessing agents affect the material durability. •• Keep the cable inlet dry.

3.4 Touchscreen The electrosurgical generator is equipped with a user friendly touchscreen. The control buttons are activated by tapping the corresponding part on the screen with the finger tip. The home screen displays the current settings of the selected output socket, i.e. MONOPOLAR or BIPOLAR. The ESG­‑150 provides 2 different displays of the home screen to serve the requirements of different users: -- The Advanced User Level -- The Basic User Level For detailed information on the 2 user levels refer to the section “5.2 User level” on page 29. 3.4.1 Home screen at “Advanced User Level” This is the default home screen. It allows the user to adjust the power level and the effect level precisely for each mode. Buttons

Figure 3.5

Buttons on the home screen at “Advanced User Level”

1) Mode selection for cutting To select a cutting mode. 2) Mode selection for coagulation To select a coagulation mode.

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Product description

3) Plus and minus button To increase and decrease the power. 4) Effect button To increase and decrease the effect. 5) Menu To open the screen [Main Menu]. 6) Output socket button [Monopolar] To select the output socket for monopolar procedures/modes. 7) Output socket button [Bipolar] To select the output socket for bipolar procedures/modes. Indicators and displays

Figure 3.6

Indicators and displays on the home screen

1) Output socket name Displays the name of the currently selected output socket. 2) Foot switch indicator Indicates if a compatible foot switch is connected. 3) CQM indicator for neutral electrodes Indicates the connection status of a neutral electrode. 4) Setting name Displays the selected user-defined settings. If no setting is selected, then this line is blank. 5) Power level Displays the selected power level. 6) Effect level Displays the selected effect level. 3.4.2 Home screen at “Basic User Level” This home screen provides 5 predefined settings for each mode. When the user increases or decreases the value then power and effect are automatically adapted.

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Product description

Buttons

Figure 3.7

Buttons on the home screen at “Basic User Level”

1) Mode selection for cutting To select a cutting mode. 2) Mode selection for coagulation To select a coagulation mode. 3) Plus and minus button To increase and decrease the level of combined power and effect. 4) Menu To open the screen [Main Menu]. 5) Output socket button [Monopolar] To select the output socket for monopolar procedures/modes. 6) Output socket button [Bipolar] To select the output socket for bipolar procedures/modes.

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Product description

Indicators and displays

Figure 3.8

Indicators and displays on the home screen

1) Output socket name Displays the name of the currently selected output socket. 2) Foot switch indicator Indicates if a compatible foot switch is connected. 3) CQM indicator for neutral electrodes Indicates the connection status of a neutral electrode. 4) Setting name Displays the selected user-defined settings. If no setting is selected, then this line is blank. 5) Power/effect level Displays the selected level of combined power and effect. 6) Status bar Displays the selected level of combined power and effect.

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