Olympus ESG-400 Instructions For Use Manual
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Olympus ESG-400 Instructions For Use Manual

Olympus ESG-400 Instructions For Use Manual

Electrosurgical generator
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INSTRUCTIONS FOR USE
ELECTROSURGICAL GENERATOR
ESG-400
WB91051W
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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  • Page 1 INSTRUCTIONS FOR USE ELECTROSURGICAL GENERATOR ESG-400 WB91051W Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

  • Page 3: Table Of Contents

    5.3 Select procedure ......................39 5.4 Assign foot switch and autostart function ................40 5.5 MENU push button ......................42 6 Using the ESG-400 with a neutral electrode ..............57 6.1 Safety notes for neutral electrode use ................57 6.2 Correct usage of neutral electrodes ................57 6.3 Conditions of the CQM indicator ..................59...
  • Page 4 8.4 Switching on the electrosurgical generator ..............80 8.5 Automatic mist and smoke evacuation ................80 8.6 Selecting output settings ....................81 8.7 HF instrument recognition ....................83 8.8 Bipolar modes SalineCut and SalineCoag ..............86 8.9 Bipolar coagulation mode RFCoag .................86 8.10 Activating ........................88 8.11 Troubleshooting ......................91 9 After use .........................104 9.1 Safety notes for after use ....................104...

  • Page 5: Using This Document

    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.
  • Page 6 Using this document 1.3.1 General safety notes General safety notes are located at the beginning of the instructions for use. They address safety issues that apply to the general use and handling of the product. 1.3.2 Specific safety notes Specific safety notes are located at the beginning of a chapter or section. They address safety issues that are specific to the information and actions described in the chapter or section.

  • Page 7: Safety Information

    ‒ General safety notes 2.1 Intended purpose Intended use and indications 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. 2.1.1 Relative contraindications Relative contraindications of electrosurgical interventions: ‒...

  • Page 8: Contact

    Some problems that appear to be malfunctions may be corrected by referring to section “8.11 Troubleshooting” on page 91. If the problem cannot be resolved using the information in this chapter, contact Olympus. ● Do not service or maintain any part of the product while in use with a patient.
  • Page 9 Unauthorized repairs and product modification can cause injury to the patient and the user. Repairs must only be performed by qualified servicing personnel that has been authorized by Olympus. Refer to the section “11.2 Repair” on page 107 for more details. Do not attempt to repair or modify the product.
  • Page 10 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.
  • Page 11 Safety information 2.3.5 Risks regarding burns WARNING Burns to the patient and/or the user ‒ The maximum output voltage characteristics of the electrosurgical generator are shown in the diagrams in section “17.5 Output characteristic diagrams” on page 124. 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.
  • Page 12 Safety information 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.
  • Page 13 Safety information 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. ‒ 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.
  • Page 14 Safety information 2.3.9 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. ‒...
  • Page 15 Safety information 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.

  • Page 16: Product Description

    The ESG-400 is equipped with several cutting and coagulation modes. All settings of the device are done via the touchscreen on the front panel. The ESG-400 is activated by a compatible foot switch or by a hand switch at the connected HF instrument. The bipolar coagulation mode BiSoftCoag also provides activation via...

  • Page 17: Features

    ‒ Automatic end of procedure detection 3.3.1 CQM – Contact Quality Monitoring for the neutral electrode When using split type neutral electrodes for monopolar electrosurgery, the ESG-400 is able to detect unintended detachment of the neutral electrode from the patient. The indicator for the contact quality monitor (CQM) shines green while the contact between the split type neutral electrode and the skin of the patient is within an acceptable resistance range.

  • Page 18: Operating Elements On The Hardware

    Product description Depending on the momentary tissue status, RCAP determines the maximum power uptake of the tissue and automatically adjusts the electrosurgical generator. For this process the geometry of the used bipolar applicator and also the individual tissue characteristics, e.g. blood perfusion, are considered.
  • Page 19 *Applied part according to standard IEC 60601-1. For a detailed explanation of the different types of sockets refer to section “8.2 Description of the output sockets” on page 79 and to chapter “6 Using the ESG-400 with a neutral electrode” on page 57.
  • Page 20 Product description 3.4.2 The rear panel LINK-IN LINK-OUT 1) Volume control To adjust the volume of the activation tone. 2) Ventilation slots 3) Identification plate 4) Potential equalization connector To increase electrical safety by potential equalization. 5) Power socket For connection to the mains electricity. 6) Fuse holder Compartment for the replaceable fuses.

  • Page 21: Operating Elements Of The Touchscreen

    Product description 3.4.3 The docking connector at the bottom 1) Docking connector To connect peripheral equipment with a 7-pin plug. 3.5 Operating elements of the 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. 3.5.1 All screen 1) Reference to output sockets indicator This indicator shows the corresponding output socket where the same symbol is printed...
  • Page 22 Product description 3) Autostart indicator This symbol indicates if the autostart function is assigned to the corresponding output socket. Blank if autostart or foot switch is not assigned. Refer to section “5.4 Assign foot switch and autostart function” on page 40. 4) Procedure name The name of the selected procedure is displayed here.
  • Page 23 Product description 1) Mode button The name of the output mode as selected in the “Mode screen” is displayed here. Press this button to switch to the “Mode screen”. If “Off” is selected, “--“ will be displayed instead of power level and effect. 2) Plus button/Minus button These buttons increase/decrease the output power level.

  • Page 24: Double-Pedal Foot Switch

    Product description 3.6 Double-pedal foot switch The double-pedal foot switch (Olympus REF: WB50402W) is included in the delivery. 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.

  • Page 25: Optional Accessories

    Product description 3.7 Optional accessories Single-pedal foot switch The single-pedal foot switch (Olympus REF: WB50403W) is an optional item which may be purchased separately. 1) Coagulation pedal (blue) This pedal is used to activate the selected coagulation mode. 2) Foot switch plug To connect the foot switch to the electrosurgical generator.
  • Page 26 This plug connects the cable to the electrosurgical generator. 3.7.2 Communication cable 0.25 m The communication cable 0.25 m (Olympus REF: MAJ-1871) is a separate accessory and connects the electrosurgical generator with the compatible ultrasonic generator. 1) Communication cable 0.25 m LINK-OUT plug This plug connects the communication cable 0.25 m either to the LINK-OUT socket...
  • Page 27 3.7.4 Adapter for UHI-2/3 The adapter for UHI-2/3 (Olympus REF: MAJ-1873) is a separate accessory and connects the electrosurgical generator with the high flow insufflation unit. The following figure shows the front side (left) and the rear side (right) of the adapter.

  • Page 28: Symbols

    Product description 3.8 Symbols This section gives an explanation for each symbol used on the product and on the packaging of the product. Symbol Explanation Defibrillation‑proof type CF applied part Follow instructions for use HF isolated patient circuit – symbol for patient circuit where there are no components installed to provide a low-impedance path to earth for HF currents Volume control...

  • Page 29: Warranty

    RF electromagnetic energy for diagnosis and treatment 3.9 Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse of the product.

  • Page 30: Installation

    4.1 Safety notes for installation The electrosurgical generator must be properly installed and commissioned by Olympus or by a person or firm commissioned and authorized by the manufacturer. Prepare the electrosurgical generator and other equipment to be used with this electrosurgical generator before each use.

  • Page 31: Connection To The Mains Electricity

    If the voltage of the facility is different from the voltage indicated on the identification plate of the electrosurgical generator, contact Olympus. Connecting 1. Confirm that the power of the electrosurgical generator is off.

  • Page 32: Automatic Mist And Smoke Evacuation

    Contact the hospital’s technical department. 4.4 Automatic mist and smoke evacuation When the electrosurgical generator is combined with an Olympus high flow insufflation unit (UHI-2 or UHI-3) via a communication cable (MAJ-1871 or MAJ-1872), the smoke and mist produced in the abdominal cavity can be evacuated simultaneously with the electrosurgical output.
  • Page 33 Installation LINK-IN LINK-OUT LINK-IN LINK-OUT 1) System connector 2) Electrosurgical generator 3) Adapter for UHI-2/3 4) High flow insufflation unit (UHI-2 or UHI-3) 1. Use the adapter for UHI-2/3 (MAJ-1873) and the communication cable (MAJ-1871 or MAJ-1872) to connect the UHI-2 or UHI-3 with the electrosurgical generator. The compatible high flow insufflation unit cannot be connected directly to the electrosurgical generator.
  • Page 34 Installation 3. Connect the LINK-IN or LINK-OUT plug of the communication cable 10 m to the LINK-IN or LINK-OUT socket of the adapter for UHI-2/3. 4. Secure each plug by pushing it in while turning the screws on both sides of the plug. 5.

  • Page 35: Connecting The Foot Switch

    Installation LINK-IN LINK-OUT LINK-IN LINK-OUT 1) Compatible high flow insufflation unit (UHI-2 or UHI-3) 2) System connector 3) Compatible ultrasonic generator 4) Electrosurgical generator 5) Communication cable 0.25 m (MAJ-1871) 6) Communication cable 10 m (MAJ-1872) 7) Adapter for UHI-2/3 1.
  • Page 36 Installation CAUTION Improper connection ‒ Connect the foot switch plug securely to the electrosurgical generator. Otherwise, output may not be activated. In this case, the HF instrument could cut the tissue mechanically, which could cause bleeding and/or perforation of the tissue. ‒...

  • Page 37: Basic Settings And Menu

    Basic settings and menu 5 Basic settings and menu The electrosurgical generator is equipped with a user friendly touchscreen that allows the operator to select and modify various settings. Furthermore, push buttons right from the touchscreen provide a fast access to frequently used functions. This chapter describes all available functions of the electrosurgical generator.

  • Page 38: Push Button Hierarchy

    Basic settings and menu *Available only in software version 4.11.01.00-A and above. **Available only in software versions 4.12-A and above. 5.2 Push button hierarchy The push buttons allow an immediate access to the “Select Procedure screen”, “Assign Foot switch screen” and “Select Menu screen”. Refer to the next chapters for a detailed description.

  • Page 39: Select Procedure

    Basic settings and menu 1) Select Procedure screen 2) Assign Footswitch screen 3) Select Menu screen 5.3 Select procedure The “SELECT PROCEDURE” function recalls one of the settings saved in memory.

  • Page 40: Assign Foot Switch And Autostart Function

    Basic settings and menu 1. Press the “SELECT PROCEDURE push button” on the front panel. The display changes to the “Select Procedure screen” (right). The list of procedures saved in memory is displayed. If a procedure has already been selected, this is indicated by a gray button. If no procedure has been saved, a “No procedure saved”...
  • Page 41 Basic settings and menu Furthermore, the “Autostart” function can be assigned to an output socket as well. The autostart function permits automatic activation of the output power as soon as both electrodes touch the tissue and if the impedance is in a defined range. ‒...

  • Page 42: Menu Push Button

    Basic settings and menu 5.5 MENU push button ● Press the “MENU push button” on the front panel to display the “Select Menu screen” on the touchscreen. ● To switch between the menu pages, press the “Previous button” / “Next button”. The different menu functions are described below.
  • Page 43 Basic settings and menu 5.5.1 Save procedure The “Save Procedure” function saves the output settings displayed on the touchscreen for up to 39 different procedures. New procedures/settings can be saved and existing settings can be overwritten from this menu. Saving a new procedure 1.
  • Page 44 Basic settings and menu 1) Uppercase/lowercase button 2) Backspace button Switching between uppercase/lowercase characters: ● Press the “Uppercase/lowercase button” to switch between the “Keyboard screen (uppercase)” (left) and “Keyboard screen (lowercase)” (right). Deletion of characters: ● Press the “Backspace button” to delete the last character being displayed in the procedure name area.
  • Page 45 Basic settings and menu If the procedure name already exists, a confirmation window will appear and ask to overwrite the procedure (left). ● To overwrite the procedure, press the “OK button” in the confirmation window (left). An information window will appear for a few seconds confirming the procedure is being overwritten.
  • Page 46 Basic settings and menu 4. Press the “Cancel button” on the “Save Procedure screen” (left), and the display returns to the “Select Menu screen” (right). Overwriting an existing procedure 1. After pressing the “MENU push button”, press the “Save Procedure button” on the “Select Menu screen”...
  • Page 47 Basic settings and menu 4. If the procedure name to be overwritten is correct, press the “OK button” in the confirmation window (left). An information window will appear for a few seconds confirming the procedure is being overwritten. The information window disappears, and the “All screen” will be displayed (right). If an incorrect procedure name is selected: ●...
  • Page 48 Basic settings and menu 3. If the procedure name to be deleted is correct, press the “OK button” in the confirmation window (left). An information window will appear for a few seconds confirming the procedure is being deleted. The information window disappears, and the “Select Menu screen” will be displayed (right).
  • Page 49 Basic settings and menu 1. After pressing the “MENU push button”, press the “Languages button” on the “Select Menu screen” (left). The screen changes from the “Select Menu screen” to the “Select Language screen” (right). The currently selected “Language button” is highlighted. 2.
  • Page 50 Basic settings and menu If an incorrect language is selected: ● Press the “Cancel button” in the confirmation window (left). The confirmation window disappears, and the “Select Language screen” is displayed. Select the correct language. 5.5.4 Touch Tone This function activates/deactivates an audible feedback tone when a touchscreen button is pressed.
  • Page 51 Basic settings and menu 1. After pressing the “MENU push button”, press the “Next button” on the “Select Menu screen” (left). The “Select Menu screen” switches to the next page (right). 2. Press the “Autostart Setup button” on the “Select Menu screen” (left). The screen changes from the “Select Menu screen”...
  • Page 52 Basic settings and menu 1. After pressing the “MENU push button”, press the “Next button” on the “Select Menu screen” (left). The “Select Menu screen” switches to the next page (right). 2. Press the “Software Version button” on the “Select Menu screen” (left). The screen changes from the “Select Menu screen”...
  • Page 53 The display returns either to the “Select Menu screen” or to the “All screen”. 5.5.8 Service This function can be accessed by Olympus staff and service technicians only. It is password protected and not intended for customer use. 5.5.9 Error History This function shows the history of the last 100 errors, including the information messages.
  • Page 54 Troubleshooting” on page 91. 5.5.10 Alarm Tones When an error message is displayed by the ESG-400 a certain alarm tone sounds, depending on the priority of the alarm. For alarms with a low or medium priority the alarm tones can be switched off, using this function.
  • Page 55 Basic settings and menu 1. Press the [MENU] button. The [Select Menu] screen is displayed. 2. Tap [Alarm Tones]. The [Alarm Tones] screen is displayed and the current setting for alarm tones is highlighted. 3. Select the preferred setting. 4. Tap [OK] to confirm the setting. On the error message Every error message with a low or medium priority provides the function to switch the alarm tones on or off.
  • Page 56 Basic settings and menu 1) Common area ● After pressing the “MENU push button”, press the “Plus button” or “Minus button” in the “Volume” section of the “Select Menu screen”. ‒ The “Plus button” increases the output tone volume. ‒ The “Minus button” decreases the output tone volume. ‒...

  • Page 57: Using The Esg-400 With A Neutral Electrode

    Using the ESG-400 with a neutral electrode 6 Using the ESG-400 with a neutral electrode Only for monopolar treatments Only for monopolar treatments, neutral electrodes are required to return the HF current from the active electrode of the HF instrument back to the electrosurgical generator. In bipolar electrosurgery both electrodes, the active and the return electrode, are implemented within the HF instrument.
  • Page 58 Using the ESG-400 with a neutral electrode DANGER Maximum output power for infants neutral electrodes When using neutral electrodes for infants (patient weight 0…15 kg) avoid output settings which exceed the maximum output power for the neutral electrode (refer to the instruction manual of the neutral electrode).

  • Page 59: Conditions Of The Cqm Indicator

    Using the ESG-400 with a neutral electrode For the removal of the neutral electrode, do not peel off the neutral electrode by pulling the cable. Start the plate removal at a corner. Slowly peel back the plate. Otherwise, skin injury may result.
  • Page 60 Using the ESG-400 with a neutral electrode Preparations 1. Before connecting any neutral electrode to the electrosurgical generator, make sure the contact quality monitor indicator for split type neutral electrodes illuminates red and the contact quality monitor indicator for non-split type neutral electrodes is off.

  • Page 61: Verifying The Cqm Indicator

    Using the ESG-400 with a neutral electrode 6.5 Verifying the CQM indicator When using a split type neutral electrode Verify that the contact quality monitor indicator for split type neutral electrodes illuminates green. If the split type neutral electrode is attached to the patient properly, then no confirmation window is displayed.

  • Page 62: Before Use

    ‒ Should the slightest irregularity be suspected, do not use the electrosurgical generator and refer to section “8.11 Troubleshooting” on page 91. If the irregularity is still suspected after consulting this chapter, contact Olympus. 7.1.1 Inspecting the power switch, touchscreen and push buttons ●...
  • Page 63 Before use 7.1.2 Inspecting the start screen and start tone Confirm that the “Start screen” (see above) is shortly displayed on the touchscreen, then the “All screen” with the last settings of all corresponding output sockets (example see below) is displayed and the electrosurgical generator is ready for use.
  • Page 64 2. Confirm that all equipment is switched on. If the communication indicator does not illuminate even after the above check, contact Olympus. 7.1.4 Inspecting the touchscreen and push buttons The touchscreen displays control buttons which can be activated by touching the corresponding part on the screen.
  • Page 65 Before use ‒ After pressing the “Plus button”/“Minus button”, confirm that the output level is changed accordingly. Otherwise, inappropriate output can cause burns to the patient and/or user, patient bleeding and/or perforation. Inspecting the touchscreen operation 1. Press the “MONOPOLAR 1 button” on the marked area of the “All screen” (left). The “Set screen”...
  • Page 66 Before use The “Menu screen” appears showing different control buttons (see below). 2. Press the “Return button” on the “Menu screen” (left). The screen changes from the “Menu screen” to the “All screen” (right). 7.1.5 Inspecting the foot switch connection 1.

  • Page 67: Procedure After Inspection

    Before use 1) Double-pedal foot switch button 2) Single-pedal foot switch button 7.1.6 Inspecting the alarm function WARNING If the alarm function is not normal, the electrosurgical generator might fail to detect an equipment error and this may result in unexpected burns, perforation and/or bleeding. Be sure to inspect the alarm function before use.

  • Page 68: Power Settings

    PK AutoCoag*/** Seal**/*** * Mode available only in software versions 4.00-A and above. ** Mode available only via the UNIVERSAL socket with Olympus HF instruments. *** Mode available only in software versions 4.12-A and above. 7.3.2 Description of monopolar modes The following descriptions comply with the requirements of the standard IEC 60601-2-2.
  • Page 69 Before use BlendCut Cutting of varying tissue structures with increased coagulation capabilities. For monopolar cutting electrodes like knife electrodes, pencil electrodes, loop electrodes. Control characteristics ................Increased crest factor Maximum output voltage ....................1400 V Maximum output current ....................1.2 A Waveform ................
  • Page 70 Before use SoftCoag Coagulation of tissue with little sticking and carbonization with monopolar coagulation electrodes like coagulation forceps, ball electrodes. Maximum output voltage ....................220 V Maximum output current ....................3.2 A Waveform ....................Continuous sinusoidal Crest factor¹ .........................n/a Range of power levels².....................5 to 200 W Default power level³...
  • Page 71 Before use ¹ Crest factor at rated load specified for modulated sinusoidal alternating current modes only. ² The output power is the continuous power (W) which can be applied during the activation of the electrosurgical generator. The actual applied power depends on the tissue characteristics, e.g.
  • Page 72 Before use ⁴PK SoftCut* Cutting of varying tissue structures bipolar cutting electrodes like PK Spatula. Enhanced smoke reduction. Maximum output voltage ....................580 V Maximum output current ....................1.5 A Waveform ....................Intermittent sinusoidal Crest factor .........................n/a Range of power levels ..................10 to 200 W Default power level ......................
  • Page 73 Before use AutoCoag Coagulation of tissue with little sticking and carbonization with bipolar coagulation electrodes like coagulation forceps. Automatic end of procedure detection. Maximum output voltage ....................220 V Maximum output current ....................1.4 A Waveform ....................Continuous sinusoidal Crest factor¹ .........................n/a Range of power levels².....................1 to 120 W Default power level³...
  • Page 74 Before use FineCoag Coagulation of tissue with little sticking and carbonization with bipolar coagulation electrodes like bipolar forceps. Acoustic feedback on coagulation progress* Maximum output voltage ....................220 V Maximum output current ....................3.3 A Waveform ....................Continuous sinusoidal Crest factor¹ .........................n/a Range of power levels²....................1 to 40 W Default power level³...

  • Page 75: Tissue Effects Depending On The Power Level And Effect Level

    Before use ⁴Seal** Advanced bipolar vessel sealing with Olympus POWERSEAL instruments. Automatic end of sealing detection. Audible feedback. Maximum output voltage ....................220 Vp Maximum output current ....................4.6 A Waveform ....................Continuous sinusoidal Crest factor¹ .........................n/a Maximum output power ....................320 W The maximum output power for the Seal mode also depends on the POWERSEAL instrument that is used.
  • Page 76 Before use 7.4.2 Tissue effects for bipolar modes Mode name Results when increasing/decreasing Results when increasing/decreasing the power level the effect level BipolarCut Increased/decreased thermal effect. Increased/decreased thermal effect. SalineCut Increased/decreased cutting capability. PK PureCut* PK SoftCut* PK LoopCut* PK MorceCut* BiSoftCoag For short time applications: increased/ Increased/decreased coagulation...

  • Page 77: Use

    CAUTION Compatible HF instruments Olympus HF instruments should be used for electrosurgical procedures. For details, refer to the instruction manual of the HF instrument. If you have any questions concerning the applicability of your HF instrument, please contact Olympus.
  • Page 78 CAUTION Connection to the wrong receptacle A connection of a 1-pin 4 mm plug to any other receptacle except the right-hand- side receptacle (highlighted by a white ring) of the MONOPOLAR 1 socket and the MONOPOLAR 2 socket may destroy the socket during activation. CAUTION No connection of a 2-pin plug with 4 mm pin diameters Do not connect a 2-pin 4 mm plug (e.g.

  • Page 79: Description Of The Output Sockets

    8.2 Description of the output sockets Monopolar and bipolar instruments The electrosurgical generator can be used with monopolar cutting and coagulation instruments as well as with bipolar cutting and coagulation instruments. The HF instruments must have an appropriate plug to connect either into the monopolar sockets or the bipolar socket or the universal socket (see socket description below).

  • Page 80: Connecting Hf Instruments

    UNIVERSAL socket (applied part) Suitable for 7‑pin bipolar multifunctional plugs (Olympus specific) and offers HF instrument recognition. For a detailed description, refer to section “8.7 HF instrument recognition” on page 83. 8.3 Connecting HF instruments Proper connections Securely connect the HF instrument. Otherwise, insufficient output might occur during treatment and, in this case, mechanical tissue cutting by the HF instrument may occur and cause bleeding or perforation of the patient.

  • Page 81: Selecting Output Settings

    ‒ If exhaust does not stop 5 seconds after stopping the output, the compatible high flow insufflation unit may be malfunctioning. Disconnect the communication cable and contact Olympus. ‒ Confirm that the electrosurgical generator is turned ON. Otherwise, the automatic mist and smoke evacuation of the compatible high flow insufflation unit will not work.
  • Page 82 ‒ The power level displayed in the “All screen” or “Set screen” is the maximum power (watts) which can be applied during the activation of the electrosurgical generator. The actual applied power depends on the tissue characteristics (e.g. resistance). ‒ If the power level of any mode is below the minimum allowable value, the “Set screen” or the “All screen”...

  • Page 83: Hf Instrument Recognition

    For detailed information about the settings, refer to the instructions for use of the HF instruments or cables. The next paragraph describes the display changes if an Olympus device with HF instrument recognition capabilities will be connected via the UNIVERSAL socket as depending on the...
  • Page 84 If the current displayed settings of mode, power level and effect are within the allowed range of the connected Olympus HF instrument but not the default instrument settings, a confirmation window as shown above will appear. ● Press the “OK button” to use the default instrument setting and the display switches to the “All screen”...
  • Page 85 If the displayed settings are allowed for the Olympus HF instrument but at least one setting of power level or effect of an unselected mode is out of range of the allowed Olympus HF instrument settings, a confirmation window as shown above will appear.

  • Page 86: Bipolar Modes Salinecut And Salinecoag

    8.7.1 The set screen for the Seal mode When using the Seal mode with an Olympus POWERSEAL instrument, the set screen is configured differently compared to other modes. ‒ For the POWERSEAL instruments there are no cutting modes available. All cutting modes are set to [Off] automatically.
  • Page 87 If the procedure is not finished after 999 minutes and 59 seconds (“999:59”), the counter restarts from “00:00”. The energy counter changes as follows: “0.00kJ”...“9.99 kJ”, “10.0 kJ”...“99.9 kJ”, “100 kJ”...“999 kJ”. After exceeding an energy of “999 kJ” the counter changes to “> 1 MJ” (Mega joules).

  • Page 88: Activating

    Activation with RCAP The medical purpose of RFCoag with RCAP (Resistance Controlled Automatic Power) mode is used to achieve deep tissue coagulation without significant tissue desiccation. ● To activate the RFCoag with RCAP mode, press the “RCAP button” in the “Set screen” until the “RCAP button”...
  • Page 89 ‒ To prevent patient burns, perforation and bleeding, be sure that you see the tip of the HF instrument in the endoscopic image during activated output in endoscopic procedures. ‒ Do not bring the tip of the HF instrument close to a metal clip or other accessories. The tissue around the metal clip or the HF instrument may be burned.
  • Page 90 ‒ After exceeding the time limit, an error window (E115) appears, an alarm signal can be heard and the output is deactivated. To continue the procedure, release the foot switch pedal or hand switch button of the HF instrument and the electrosurgical generator can be reactivated again.

  • Page 91: Troubleshooting

    8.11 Troubleshooting CAUTION Repairs must only be carried out by Olympus or a firm authorized by Olympus. ‒ If the electrosurgical generator does not functioning properly, immediately stop the procedure. ‒ Check if any error window is displayed.
  • Page 92 The touchscreen cannot be An object is in contact with the Remove the object. controlled. touchscreen. The touchscreen is not properly Contact Olympus. calibrated. Malfunction of the touchscreen. Stop using the electrosurgical generator and press the power switch to turn off the electrosurgical generator.
  • Page 93 If an HF instrument is connected Improper connection of the Check the Olympus to the UNIVERSAL socket, the Olympus HF instrument plug with HF instrument plug for correct electrosurgical generator does the UNIVERSAL socket on the connection. not recognize the connected front panel of the electrosurgical HF instrument.
  • Page 94 Contact Olympus. Automatic mist and smoke The settings are erroneous. Correct the settings of the evacuation does not work.
  • Page 95 8.11.1 Error messages, codes and measures The error messages are configured as shown in the following example. 1) Caution symbol and error code 2) Error title 3) Remedial actions The OK button is not available in software versions lower than 4.00-A. If an error occurs: ‒...
  • Page 96 If an error code is displayed, perform the indicated remedial actions below. The error messages in the following table are sorted numerically according to the error code. If the problem cannot be resolved by the described remedial action, contact Olympus. Error...
  • Page 97 Malfunction of the If the problem persists, contact 2. If the problem persists, electrosurgical generator. Olympus. contact Olympus. E022 Error An activated HF instrument - Avoid metal-to-metal sparks. If the problem persists, generates a metal-to-metal - Device can be immediately contact Olympus.
  • Page 98 Unknown instrument An Olympus HF instrument Check the connection of the E147 1. Reconnect the instrument has not been properly Olympus HF instrument to the … to the UNIVERSAL socket. connected to the UNIVERSAL UNIVERSAL socket. E149 2. If the problem persists, socket.
  • Page 99 Malfunction of the If the problem persists, contact 2. If the problem persists, electrosurgical generator. Olympus. contact Olympus. E188 Excessive HF leakage The high frequency leakage Check if the electrosurgical current current has exceeded the generator or the patient is 1.
  • Page 100 No instrument connected An Olympus HF instrument Ensure the proper connection 1. Connect an instrument to and/or connection cable has of the Olympus HF instrument the UNIVERSAL socket. not been properly connected and/or the connection cable to 2. If the problem persists, to the UNIVERSAL socket.
  • Page 101 **Only in software versions 4.12-A and above. 8.11.2 Tones and messages regarding incomplete seal cycle In relation with the bipolar Seal mode and the compatible Olympus instruments, information messages can be displayed. The information messages are configured as shown in the...
  • Page 102 1) Information symbol and info code 2) Message title 3) Remedial actions If a condition for the information message occurs when using the Seal mode, then the following takes place automatically: ‒ A 4-tone sequence sounds, indicating the incomplete seal. ‒...
  • Page 103 Info Message Cause Remedy code i764 Incomplete seal cycle The instrument jaws are not 1. Release the hand switch or 1. Inspect the seal. closed completely. Insufficient foot switch. 2. Confirm proper tissue amount of tissue is grasped. 2. Open the instrument jaws contact.

  • Page 104: After Use

    After use 9 After use This chapter describes the necessary steps to be performed after each use. This includes: ‒ Safety notes ‒ Disconnecting 9.1 Safety notes for after use WARNING Do not reuse single-use accessories Always discard used disposable neutral electrodes and HF instruments. Reprocessing single use devices may lead to changes in material characteristics such as metallic corrosion and dulled edges, ceramic and plastic deformation or splitting which may impact the strength of the device and compromise device performance.

  • Page 105: Reprocessing

    Reprocessing 10 Reprocessing After each use, immediately perform the procedures as described in the following sections. If cleaning is delayed, debris encrustation can become a source of infection. Encrustation can also result in malfunction of the electrosurgical generator. 10.1 Safety notes for reprocessing WARNING ‒...

  • Page 106: Disinfection

    Reprocessing Cleaning procedure Perform the following cleaning procedure after use. If necessary, let the product cool down. If cleaning is delayed, debris will solidify and it may be difficult to effectively clean the surfaces. 1. Take a soft, lint-free cloth that is soaked with a suitable reprocessing agent. 2.

  • Page 107: Maintenance, Repair And Shipment

    Furthermore, the appropriate equipment for performing the safety check must be available. Details on the annual safety check are described in the maintenance manual for the ESG-400. Contact the local Olympus representative for the latest version of the maintenance manual.

  • Page 108: Shipment

    Olympus will not assume any liabilities for human injuries or equipment damage caused as a result of servicing or repairs by a person other than the Olympus qualified service personnel. When sending products to an authorized service center for repair or warranty claims, use the original cardboard packaging for the transport of the product.

  • Page 109: Storage And Disposal

    Storage and disposal 12 Storage and disposal This chapter provides information on the following: ‒ Storage of the electrosurgical generator ‒ Disposal of the electrosurgical generator 12.1 Storage To prevent damage of the electrosurgical generator during storage, observe the following: ‒...

  • Page 110: Ordering Information

    Ordering information 13 Ordering information Description Catalog number Electrosurgical generator ESG-400 WB91051W Ultrasonic generator USG-400 USG-400 Energy cart TC-E400 N3635730 HF cable “MAJ-860”, monopolar, 3.5 m, pin diameter: 8 mm MAJ-860 Connecting cable for neutral electrode “MAJ-814” MAJ-814 Connecting cable for neutral electrode...

  • Page 111: Compatible Equipment

    Compatible equipment 14 Compatible equipment Olympus recommends the use of equipment as listed in this chapter. If combinations are used that are not listed in this chapter, the user takes the full responsibility. Future equipment can also be compatible. For more information, contact an Olympus representative.
  • Page 112 Compatible equipment MAJ-860 UHI-2 ¹) WB50403W WA99510A ¹) Monopolar and bipolar HF instruments Electrosurgical instruments used with videoscopes and fiberscopes (without S‑cord connector) Neutral electrodes (with connecting cable), see next page. **** Neutral electrodes (without connecting cable), see next page. Not licensed in accordance with Canadian law.

  • Page 113: Compatible Neutral Electrodes

    Compatible equipment 14.2 Compatible neutral electrodes Recommended compatible neutral electrodes Olympus Description Catalog number WA99512C* Neutral electrode, for newborns, with cable Patient weight < 5 kg WA99513A* Neutral electrode, for children, without cable Patient weight 5…15 kg WA99513C* Neutral electrode, for children, with cable Patient weight 5…15 kg...
  • Page 114 Compatible equipment Manufacturer Neutral electrode description Model Covidien Patient weight > 13.6 kg E7507, E7507-DB, E7509, E7509-B Covidien Patient weight 2.7...13.6 kg E7510-25, E7510-25DB* *Not licensed in accordance with Canadian law.

  • Page 115: Technical Data

    Technical data 15 Technical data 15.1 Specifications for the ESG-400 Size Width ..........................370 mm Height ...........................156 mm Depth ..........................465 mm Volume ........................25752 cm³ Weight ........................... 12.5 kg Weight of packaging ......................2.3 kg Power supply Voltage range ..............AC 100 to 120 V / AC 220 to 240 V Frequency ......................

  • Page 116: Sockets

    For 2-pin plugs ..............Pin∅ 4 mm, 28.8 mm pin spacing For coaxial plugs ....................Pin∅ 4 / 8 mm UNIVERSAL socket For 7-pin plugs, for special Olympus instruments with instrument recognition Neutral electrode socket For plugs with 2 receptacles ............ ∅ 2.5 mm, 10 mm pin spacing 15.4 Resistance range for CQM...

  • Page 117: Electromagnetic Compatibility

    Electromagnetic compatibility 16 Electromagnetic compatibility Precautionary measures Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC). This device is to be used only for the purposes described in this document and has to be installed, set up, and operated in compliance with the EMC guidelines.
  • Page 118 Electromagnetic compatibility Guidelines and manufacturer’s declaration – electromagnetic immunity This electrosurgical generator is intended for use in the electromagnetic environment specified below. The customer or the user of this electrosurgical generator should assure that it is used in such an environment.
  • Page 119 Electromagnetic compatibility Guidance and manufacturer’s declaration – electromagnetic immunity This electrosurgical generator is intended for use in the electromagnetic environment specified below. The customer or the user of this electrosurgical generator should assure that it is used in such an environment.

  • Page 120: Additional Information

    Additional information 17 Additional information 17.1 Alarm system An alarm condition is indicated about 1 second after detection and securing. Log file for alarm conditions The alarm system provides a log of occurrences of alarm conditions. The oldest log is overwritten by the latest log when the capacity of 4096 logs is reached.

  • Page 121: Tone Information

    Additional information 17.2 Tone information 17.2.1 General tones Type Frequency Duration Volume Start tone 500 / 1000 / 2000 Hz 0.375 s ≥ 65 dB (A) (not adjustable) Touch tone 500 Hz 0.09 s ≥ 65 dB (A) (not adjustable) Alarm tones 200 Hz 0.17 s...
  • Page 122 Additional information Bipolar modes Mode Frequency Duty cycle Volume BipolarCut 587 Hz Continuous signal ≥40 to ≥65 dB (A) SalineCut 587 Hz Continuous signal ≥40 to ≥65 dB (A) PK PureCut* 587 Hz Continuous signal ≥40 to ≥65 dB (A) PK SoftCut* 587 Hz Continuous signal...

  • Page 123: Mode Characteristics According To Iec 60601-2-2

    Additional information * Mode available only in software versions 4.00-A and above. ** Mode available only in software versions 4.12-A and above. 17.2.3 Selectable mode tones for PK Coag mode The PK Coag mode provides 3 different tones sequences for the acoustic feedback of the coagulation progress.

  • Page 124: Characteristics Of High Power Cut Support (Hpcs)

    Additional information 17.4 Characteristics of High Power Cut Support (HPCS) Some cutting modes are supported by the High Power Cut Support (HPCS) according to figure 9.1. The high power cut support optimizes the start of the cutting procedure by applying high power to the tissue to support immediate spark ignition and reduces the risk of mechanical cutting.
  • Page 125 Additional information Monopolar PureCut...
  • Page 126 Additional information Monopolar BlendCut...
  • Page 127 Additional information Monopolar PulseCut slow/fast...
  • Page 128 Additional information Monopolar FineCut...
  • Page 129 Additional information Monopolar SoftCoag...
  • Page 130 Additional information Monopolar ForcedCoag Load = 500 Ohm...
  • Page 131 Additional information Monopolar SprayCoag...
  • Page 132 Additional information Monopolar PowerCoag...
  • Page 133 Additional information Bipolar Cut...
  • Page 134 Additional information Bipolar SalineCut...
  • Page 135 Additional information Bipolar PK PureCut...
  • Page 136 Additional information Bipolar PK SoftCut Load = 200 Ohm...
  • Page 137 Additional information Bipolar PK LoopCut...
  • Page 138 Additional information Bipolar PK MorceCut...
  • Page 139 Additional information Bipolar BiSoftCoag...
  • Page 140 Additional information Bipolar AutoCoag...
  • Page 141 Additional information Bipolar SalineCoag...
  • Page 142 Additional information Bipolar HardCoag...
  • Page 143 Additional information...
  • Page 144 Additional information Bipolar RFCoag (w/o RCAP)
  • Page 145 Additional information Bipolar FineCoag...
  • Page 146 Additional information...
  • Page 147 Additional information Bipolar PK Coag...
  • Page 148 Additional information Bipolar PK SoftCoag...
  • Page 149 Additional information Bipolar PK AutoCoag...
  • Page 150 Additional information Bipolar Seal 1000 10000 Load [Ohm]...

  • Page 151: Glossary

    Glossary 18 Glossary Ampere The ampere or amp (symbol A) is the base unit of electric current in the International System of Units. Applied part An applied part, according to standard IEC 60601-1, is a part of a medical electrical equipment that comes into physical contact with the patient, e.g.
  • Page 152 Glossary Cutting When the generated heat causes the intracellular fluid to rapidly evaporate, then this results in an explosive burst of the cell membrane. To achieve this, a very high voltage of approximately 200 V is required. Such a high voltage generates sparks between the tissue and the instrument’s electrode/s.
  • Page 153 Glossary Abbreviation for Food and Drug Administration, a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Grounding Making an electric connection between a given point in a system and a local earth. The connection to local earth may be intentional or unintentional/accidental and it may be permanent or temporary.
  • Page 154 HF current. For more information refer to the chapter “6 Using the ESG-400 with a neutral electrode” on page 57. Abbreviation for Unique Device Identifier. The Unique Device Identifier is a label on the medical device with human- and machine-readable information, which allows to uniquely identify the device through distribution and use.

  • Page 155: Index

    Index 19 Index Accessories ............................25 Accessories, risks ..........................10 Alarm tones ............................120 All screen ...............................21 Applied part according to standard IEC 60601-1 ..................19 AutoCoag, bipolar mode ........................73 Automatic end of procedure detection ....................18 Automatic mist and smoke evacuation ....................32, 80 Autostart ............................40, 50 Basic settings ............................37 BipolarCut, bipolar mode ........................71 Bipolar modes, descriptions ........................71...
  • Page 156 Index ForcedCoag, monopolar mode ......................70 Front panel ............................18 FSM ..............................17 HardCoag, bipolar mode ........................73 Heart, potential hazards ........................12 High Power Cut Support ........................17 HPCS ..............................17 i763, incomplete seal ...........................102 i764, incomplete seal ...........................103 i765, incomplete seal ...........................103 i766, incomplete seal ...........................103 i767, incomplete seal ...........................103 Incident reporting .............................8 Indications ...............................7...
  • Page 157 Index PK SoftCoag, bipolar mode ........................74 PK SoftCut, bipolar mode ........................72 Potential equalization ..........................32 PowerCoag, monopolar mode .......................70 POWERSEAL instrument ........................86 Procedural hazards ..........................14 PulseCut Fast, monopolar mode ......................69 PulseCut Slow, monopolar mode ......................69 PureCut, monopolar mode ........................68 RCAP ..............................17, 86 Rear panel .............................20 Relative contraindications ........................7 Resistance Controlled Automatic Power ....................17...
  • Page 160 W7091601_12 2021-11-09 en(US) © Copyright 2021 Olympus Winter & Ibe GmbH...

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