Page 1 INSTRUCTIONS FOR USE ELECTROSURGICAL GENERATOR ESG-410 ESG-410 UNIVERSAL 1 BIPOLAR UNIVERSAL 2 MONOPOLAR 1 SURGISABER MONOPOLAR 2 NEUTRAL WA91307W Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Page 3: Table Of Contents
Contents 1 Using this document......................7 1.1 User instructions ......................7 1.2 Conventions throughout this document ................7 1.3 Safety-related information in this document ..............7 2 Safety information ......................9 2.1 Intended purpose ......................9 2.2 Contact .........................10 2.3 General safety notes ....................10 3 Product description ......................19 3.1 Scope of delivery ......................19 3.2 Product functions ......................19 3.3 Operating elements on the hardware ................21...
Page 4 15.1 System chart ......................95 15.2 Compatible neutral electrodes ...................96 15.3 Compatible foot switches ...................98 16 Technical data ........................99 16.1 Specifications for the ESG-410 ..................99 16.2 Ambient conditions for operation, storage and transport ...........99 16.3 Plug requirements ....................100 16.4 Resistance range for CQM ..................100 16.5 Specifications for cables ..................100...
Page 5 17.2 Tone information ......................102 17.3 Mode characteristics according to IEC 60601-2-2 ...........105 17.4 Characteristics of High Power Cut Support (HPCS) ..........106 17.5 Output characteristic diagrams ................106 18 Electromagnetic compatibility ..................133 19 Glossary ........................136 20 Index ..........................140...
Page 7: 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 8 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 9: Safety Information
Safety information 2 Safety information This chapter provides general safety information for using the product. The safety information includes: ‒ Intended purpose ‒ Manufacturer information ‒ General safety notes 2.1 Intended purpose 2.1.1 Intended use and indications The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in the following medical fields: ‒...
Page 10: Contact
Repair Repair of the product must only be performed by trained qualified servicing personnel that has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the safety and performance of the product. Be aware that also fuses must only be changed by an authorized service center.
Page 11 Safety information An insufficient understanding of the safety information in these instructions for use can result in death, serious injury, or equipment damage. Liquids and splashes If liquids get into the electrosurgical generator, there is a risk of electric shock and damage to the product.
Page 12 Tugging and pulling on the cables can break the electric circuit and can damage the equipment. Maintenance To ensure electrical safety and to maintain device performance, Olympus recommends to perform a safety check annually or according to national regulations and guidelines on all medical electrical equipment.
Page 13 Safety information ‒ The smoke has unpleasant odors. Olympus recommends to take adequate measures during the procedure to protect the surgical staff from inhaling unfiltered smoke, e.g. by using smoke evacuators, sufficient ventilation in the operating room or wearing surgical masks.
Page 14 Safety information ‒ Silver: 0.0000016 Ω/cm 2.3.4 Electrosurgical effects – coagulation, cutting and carbonization Coagulation A temperature of 60 to 70 °C in the area around the active electrode gradually heats the tissue cells until their intracellular fluid escapes through the cell membranes. The results are: ‒...
Page 15 ‒ The electrosurgical generator ‒ A monopolar or bipolar electrosurgical instrument for cutting or coagulation ‒ The patient’s target tissue ‒ For monopolar procedures: a neutral electrode ‒ The connecting cables 2.3.6 Monopolar electrosurgery ESG-410 UNIVERSAL 1 BIPOLAR UNIVERSAL 2 MONOPOLAR 1 SURGISABER...
Page 16 For surgical procedures where the HF current could flow through parts of the body that have a relatively small cross sectional area, the use of bipolar techniques can be desirable to avoid unwanted tissue damage. ESG-410 UNIVERSAL 1 BIPOLAR MONOPOLAR 1...
Page 17 Earth leakage currents bear the risk of thermal tissue damages. Olympus electrosurgical generators constantly monitor earth leakage currents and give an acoustic and visual feedback if the earth leakage current exceeds a certain level. These feedbacks make the physician aware that there is an increased risk of burns for the patient.
Page 18 Safety information Direct coupling Direct coupling is the current flow directly from one conductor to another conductor. For example, when an active electrosurgical instrument like a cutting electrode is in contact with another metallic instrument, like a grasping forceps. Then current flows from the active cutting electrode into the grasping forceps and the grasping forceps can cause burns to non- target tissue.
Page 19: Product Description
All settings of the device are selected via the touchscreen on the front panel. The ESG-410 is activated either via a compatible foot switch or via a hand switch at the connected instrument. The ESG-410 is connected to the local power supply.
Page 20 ‒ Fast Spark Monitor (FSM) CQM – Contact Quality Monitoring for the neutral electrode When using split type neutral electrodes for monopolar electrosurgery, the ESG-410 is able to detect unintended detachment of the neutral electrode from the patient. The indicator for the contact quality monitor (CQM) is green while the contact between the split type neutral electrode and the skin of the patient is within an acceptable resistance range.
Page 21: Operating Elements On The Hardware
SURGISABER MONOPOLAR 2 NEUTRAL 1) Output socket UNIVERSAL 1* To connect an Olympus HF instrument with instrument recognition. 2) Output socket UNIVERSAL 2* To connect an Olympus HF instrument with instrument recognition. 3) Output socket BIPOLAR* To connect a bipolar HF instrument.
Page 22: Operating Elements On The Touchscreen
To increase electrical safety by potential equalization 4) Fuse holder Compartment for the replaceable fuses. 5) Power socket To connect the ESG-410 to the mains electricity. 6) Foot switch sockets To connect a compatible foot switch. 7) LINK-OUT socket To connect a communication cable for peripheral equipment with a 14-pin plug.
Page 23 ESG-410. UNIVERSAL panes accessible after connecting instrument The 2 Universal panes on the left side represent the 2 Olympus specific output sockets UNIVERSAL 1, UNIVERSAL 2. These 2 panes are accessible only when a correspondent Olympus instrument is connected to the output socket.
Page 24 Product description 10) CQM info button The neutral electrode indicator displays the current state of the CQM. The information screen explains the different states of the CQM. The neutral electrode setup provides the setting for baby neutral electrodes. 11) Selected cutting mode 12) Foot switch indicator 3.4.2 Set screen On the set screen the required modes and power levels are selected.
Page 25: Popups And Messages
Error messages These messages are displayed when the system detects a safety relevant issue, e.g. if the connections between the ESG-410 and a peripheral equipment like a videoprocessor are not correct. Error messages provide instructions (remedial actions) to clear the alarm.
Page 26: Symbols And Icons
Message boxes Message boxes provide helpful information to assist the user during a certain operation. For example, the following message box pops up when a new foot switch is connected to the ESG-410: 1) Message title 2) Remedial actions 3) Confirmation button to clear the message When a message box pops us, an info tone sounds.
Page 27 Product description Symbol Explanation Federal (USA) law restricts this device to sale by or on the order of a physician Medical device Refer to instructions for use Caution, consult accompanying documents Defibrillation-proof type CF applied part Manufacturer CE marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonization legislation Unique device identifier Transport conditions...
Page 28 Product description Symbol Explanation USB socket Foot switch Certification mark of the TUV Rheinland of North America, Inc. Fuse Equipotentiality terminal Non-ionizing radiation; indicates that the device includes RF transmitters or that the device intentionally applies RF electromagnetic energy for diagnosis and treatment Icons The following table gives an explanation for each icon that can be displayed on the...
Page 29: Warranty
The due date for the next regular safety check is reached. 3.7 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...
Page 30: Installation
● If the electrosurgical generator is placed on a trolley, the trolley must be of adequate strength and size to hold the electrosurgical generator securely. ● The compatible trolley for the ESG-410 is the Energy Cart TC-E410. ● Make sure that there is sufficient space at the back and at the sides of the electrosurgical generator.
Page 31: Connection Of Electrosurgical Generator To The Mains Electricity
Installation 4.4 Connection of electrosurgical generator to the mains electricity WARNING Electric shock If an unknowingly damaged electrosurgical generator is connected inadequately to the mains electricity, there is the risk that voltage is applied to the housing by internal electrical components.
Page 32: Connection Of Foot Switches
UHI-2, UHI-3 or UHI-4, smoke and mist can be evacuated simultaneously with the electrosurgical output. 4.7.1 Connecting the ESG‑410 to UHI‑2 or UHI‑3 When connecting the ESG-410 to the UHI-2/3 also refer to the instructions for use of the UHI-2/3. Preconditions ‒...
Page 33 2) Adapter “MAJ-1873” for UHI-2/3 3) Communication cable “MAJ-1872” 1. Ensure that both devices, the ESG-410 and the UHI-2/3 are switched off. 2. Connect the system plug of the adapter to the system connector of the UHI-2/3. 3. Fasten the screws on both sides of the adapter to secure the connection.
Page 34 7. Fasten the screws on both sides of the plug to secure the connection. 8. Switch on both devices. 4.7.2 Connecting the ESG‑410 to the UHI‑4 When connecting the ESG-410 to the UHI-4 also refer to the instructions for use of the UHI-4. Preconditions ‒...
Page 35 Installation ESG-410 UHI-4 1. Ensure that both devices, the ESG-410 and the UHI-4 are switched off. 2. Firmly connect one plug of the communication cable to the LINK-IN socket or the LINK- OUT socket of the UHI-4. 3. Fasten the screws on both sides of the plug to secure the connection.
Page 36: System Settings
System settings 5 System settings This chapter describes the correct operation of the touchscreen and the following basic settings are explained: ‒ Volume of activation tones ‒ Brightness of the touchscreen ‒ Alarm tones ‒ Touch tone ‒ Language selection ‒...
Page 37: Volume Control Of Activation Tones
To select if the short list or the complete list of monopolar modes can be used. 8) Options button for startup settings To select if the last HF output settings are restored after a startup of the ESG-410. 9) [Home] button To return to the home screen.
Page 38: Brightness Control
5.5 Alarm tones When an error message is displayed by the ESG-410 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 in 2 ways.
Page 39: Touch Tone
● Tap the button [AUDIO ON/OFF] to switch the alarm tones on or off. ► This setting is saved for all low/medium priority alarms as long as the ESG-410 is switched on or as long as this setting is changed on any error message.
Page 40: Date, Time And Format
► The display returns to [Settings] screen. The updated date/time/format settings are displayed. 5.9 Monopolar modes The ESG-410 provides 2 sets of monopolar modes: ‒ A set with 4 standard monopolar modes ‒ A set with all 14 monopolar modes Use this function to select the preferred set.
Page 41: Startup Settings
System settings 5.10 Startup settings [Previous settings] and [All zero] The ESG-410 provides 2 options on how to deal with HF output settings when the device is switched off: ‒ [Previous settings] The selected HF output settings are stored. When the ESG-410 is switched on again, these settings are automatically displayed.
Page 42: Assigning Foot Switches
System settings 2. Tap the [Procedure] button on the home screen. ► The [Procedure] screen is displayed. 3. Tap the [Save] button. ► The screen [New procedure] with an keyboard is displayed. 4. Enter a name for the new procedure. 5.
Page 43 System settings ● Depress the black toggle button on the foot switch. ► The foot switch indicator shifts clockwise to the next unoccupied output socket. ► The foot switch is assigned to this output socket.
Page 44: Safe Use Of Neutral Electrodes
Safe use of neutral electrodes 6 Safe use of neutral electrodes 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 45: Restriction To Only Split Type Neutral Electrodes
‒ To avoid that a non-split type neutral electrode is used unintentionally. 6.2 Restriction to only split type neutral electrodes As a safety feature, the ESG-410 provides a setting that prevents the use of non-split type neutral electrodes. If this setting is set to [Disable] and a non-split type neutral is...
Page 46: Safety Feature For Baby Neutral Electrodes
► The [Neutral electrode] screen is displayed. ► The current setting is highlighted. 4. Select the preferred setting. For safety reasons, Olympus recommends to select [Disable]. ► The selected setting is highlighted and saved. 5. Tap [Home] to return to the home screen.
Page 47 Safe use of neutral electrodes Functionality of the baby neutral electrode setting A current flow of 350 mA serves as an indicator that the heating between the neutral electrode for newborns (patient weight less than 5 kg) and the baby’s skin is getting to high. At this stage the user is warned by an alarm tone and the following error message: If it is necessary to continue with the procedure, the user must observe the instructions that are stated within the error message:...
Page 48: Conditions Of The Cqm Indicator
If the baby neutral electrode function is set to [ON], then each time a neutral electrode is plugged to the ESG-410, the message box [Baby neutral electrode is selected] is displayed. This is to prevent that the warning message regarding excessive current comes up when working with neutral electrodes that are not for babies.
Page 49: Selecting An Appropriate Neutral Electrode
Safe use of neutral electrodes ‒ Activation stops automatically and is prevented. ‒ An alarm tone sounds and a corresponding error message is displayed. ● Follow the instructions given in the error message. Indicator for non‑split type neutral electrodes is gray ‒...
Page 50 If the baby neutral electrode function is set to [ON], then each time a neutral electrode is plugged to the ESG-410, the message box [Baby neutral electrode is selected] is displayed. This is to prevent that the warning message regarding excessive current comes up when working with neutral electrodes that are not for newborns.
Page 51: Cqm Indicator Verification
Safe use of neutral electrodes 1. Lift the locking lever of the connecting cable. 2. Position the tab of the neutral electrode evenly between the clamp jaws of the connecting cable. 3. Completely push down the locking lever to lock the clamp. 4.
Page 52: Before Use
Before use 7 Before use This chapter describes all necessary steps to prepare the product for each use and provides detailed information on each mode. 7.1 Safety notes for before use Before each operation Any irregularity or damage of the electrosurgical generator and its equipment compromises the safety.
Page 53: Inspection Before Use
Before use ‒ 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. ‒...
Page 54 2. Check that the power switch lights up. 3. Check that the touchscreen lights up. ► The start screen with the Olympus logo is displayed shortly and the Olympus jingle is played. 4. Check that the home screen is displayed after the start screen.
Page 55: Overview Of Modes
Additional modes within Olympus instruments Special Olympus instruments, e.g. the POWERSEAL instruments, enable additional modes. When such an instrument is connected to the UNIVERSAL socket, the ESG-410 automatically recognizes the instrument, and the modes and settings are accessible. All required mode information of such instruments can be found in the corresponding instrument’s instructions for use.
Page 56 Before use Maximum output voltage at effect level 3 ............... 645 V Maximum output current ....................1.5 A Rated load ........................500 Ω PlasmaCut Bipolar cutting in conductive fluid for transurethral resection (TURis). Waveform ................Continuous sinusoidal, unmodulated Crest factor ....................... 1.3 to 1.8 Range of power levels ....................1 to 320 W Effect levels ........................1 to 3...
Page 57 Before use Maximum output voltage at effect level 1 ............... 410 V Maximum output voltage at effect level 2 ............... 440 V Maximum output voltage at effect level 3 ............... 510 V Maximum output current ....................1.5 A Rated load ........................200 Ω PK SoftCut Cutting of varying tissue structures using advanced bipolar technology with enhanced smoke reduction.
Page 58 Before use Effect levels ........................1 to 3 Maximum output voltage at effect level 1 ............... 220 V Maximum output voltage at effect level 2 ............... 220 V Maximum output voltage at effect level 3 ............... 220 V Maximum output current ....................3.3 A Rated load .........................
Page 59 Before use Maximum output voltage at effect level 1 ..............2200 V Maximum output current ....................1.0 A Rated load ........................300 Ω BlendCut Cutting with enlarged coagulation zone. Waveform ................Continuous sinusoidal, modulated Crest factor ........................3 to 4.5 Range of power levels ....................1 to 200 W Effect levels ........................1 to 3 Maximum output voltage at effect level 1 ...............
Page 60 Before use PulseCut Slow Intermittent cutting and coagulation phases for controlled cutting. High Power Cut Support (HPCS) enables fast start of cutting. PulseCut Slow provides longer coagulation phases than PulseCut Fast. Control characteristics .....................HPCS Waveform ................Continuous sinusoidal, unmodulated Crest factor .......................
Page 61 Before use Waveform ................Continuous sinusoidal, modulated Crest factor ........................5 to 6.5 Range of power levels ....................1 to 120 W Effect levels ........................1 to 3 Maximum output voltage at effect level 1 ..............1270 V Maximum output voltage at effect level 2 ..............1495 V Maximum output voltage at effect level 3 ..............
Page 62: Tissue Effects Depending On The Power Level And Effect Level
Before use Maximum output current ....................0.8 A Rated load ........................500 Ω 7.5 Tissue effects depending on the power level and effect level 7.5.1 Bipolar modes Mode name Results when increasing/decreasing Results when increasing/decreasing the effect level the power level BipolarCut Increased / decreased thermal effect Increased / decreased thermal effect and...
Page 63 Before use Mode name Results when increasing/decreasing Results when increasing/decreasing the effect level the power level SoftCoag Increased / decreased coagulation speed Increased / decreased coagulation depth for short time application. Nevertheless, to achieve the full potential coagulation depth a long application time with a low power setting is necessary.
Page 64: Use
8 Use This chapter describes the following: ‒ Specific safety notes for use ‒ How to connect instruments ‒ How to set appropriate output settings for the intended procedure ‒ How to activate the output ‒ The alarm system with error messages and alarm tones ‒...
Page 65: Description Of The Output Sockets
‒ 2-pin plugs with 4 mm pin diameter, fixed pin spacing 22 mm, for foot switch activation. ‒ Coaxial plugs with 8/4 mm pin diameter, for foot switch activation. Compatible Olympus instrument families Bipolar HF-cables (reusable or single-use) for: ‒ HICURA instruments...
Page 66 ‒ Monopolar HF-cables (reusable or single-use) for: ‒ HICURA instruments ‒ HIQ+ instruments 8.2.3 UNIVERSAL 1 and UNIVERSAL 2 UNIVERSAL The UNIVERSAL sockets are suitable for special Olympus instruments or Olympus cables with instrument recognition. Compatible Olympus instrument families ‒ POWERSEAL instruments ‒ PK instruments...
Page 67: Connection Of Instruments
8.3 Connection of instruments Before connecting Only use this electrosurgical generator with compatible equipment. Refer to the chapter “Compatible equipment” on page 74. ● Check the maximum rated voltage of the other HF equipment. Make sure that the maximum output voltage of the electrosurgical generator does not exceed the rated voltage of the HF equipment that is used during the procedure.
Page 68 2) Socket pane that is switched OFF 3) Socket pane that is switched ON 8.4.1 Mode selection The mode is selected according to the type of procedure that will be performed and according to the instruments that will be used. Refer to the section “7.4 Description of modes”...
Page 69: Automatic Instrument Recognition
8.5.1 The Seal mode for Olympus POWERSEAL instruments This mode is available only when a corresponding Olympus POWERSEAL instrument is connected to the UNIVERSAL socket. The set screen for the Seal mode is configured differently compared to other modes.
Page 70 ‒ A corresponding information message is displayed, which provides information on remedial actions. To clear the information message from the touchscreen, perform the remedial action that is displayed and Tap [OK] on the touchscreen. The information message can also be cleared by re-activating the power output with the hand switch or foot switch.
Page 71: Selecting A User-Defined Procedure
Info Message Cause Remedial action code i0767 Incomplete seal cycle Automated generator time 1. Release the hand switch or foot 1. Inspect the seal. out. More time and energy switch. 2. Remove excess is needed to complete the 2. Open the instrument jaws and fluids.
Page 72 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.
Page 73: Activating
‒ If the foot switch or the hand switch of the instrument does not react, then use the power switch on the ESG-410 as an emergency stop. Considerations during activation ‒ Make sure that the tip of the activated instrument is always visible in the endoscopic image.
Page 74 The HF output is activated as long as the foot switch pedal or the hand switch at the instrument is pressed. As soon as the corresponding switch is released, the HF output stops. Activation tone During activation an activation tone sounds. It is impossible to change any setting during activation.
Page 75 ‒ For all coagulation modes the background color changes to blue.
Page 76 8.8.2 Automatic start for the bipolar mode BiSoftCoag 1) Autostart indicator 2) Options button to switch Autostart ON/OFF 3) Plus/Minus buttons for Autostart delay setting If the tissue resistance is within a defined range, then the Autostart feature permits automatic activation of the output power as soon as both electrodes of the electrosurgical instrument touch the tissue.
Page 77: Alarm System
- The user immediately must resolve the cause of the error as explained in the error message. - As soon as the error is resolved, the user can continue to use this ESG-410. 2 short honks The caution symbol - The user must take notice of the error is yellow without message.
Page 78: Troubleshooting
Check the following table to identify and correct failures. If the problem cannot be resolved by the described remedial actions, stop using the electrosurgical generator and contact Olympus. Be aware that repairs must only be performed by authorized service centers.
Page 79 Check the power cable for damages and, if necessary, replace the power cable. Malfunction of the electrosurgical Do not use this electrosurgical generator. generator. Contact Olympus. After switching on Malfunction of the touchscreen. Do not use this electrosurgical the electrosurgical generator. generator the Contact Olympus.
Page 80 Malfunction of the electrosurgical Do not use this electrosurgical generator. generator. Contact Olympus. Foot switch pedal or Improper connection of the instrument Check the plug of the instrument for hand switch of the plug with the output socket of the correct connection.
Page 81 NTFS etc. are not supported) The info message A non-split neutral electrode is 1. Disconnect the neutral electrode i1772 “Use of non-split connected to the ESG-410 and the from the ESG-410. neutral electrodes safety function regarding non-split 2. Change the setting for non-split disabled”...
Page 82 Olympus. use this electrosurgical generator. If any error occurs permanently or repetitively, do not use this electrosurgical generator and contact Olympus. E2001 System error Malfunction of the Switch the electrosurgical 1. Restart the electrosurgical electrosurgical generator. generator off and then on generator.
Page 83: After Use
After use 9 After use This chapter describes the necessary steps to disconnect the electrosurgical generator and all accessories. Disconnecting After use, disconnect the electrosurgical generator from the mains electricity and disconnect all accessories from the electrosurgical generator. 1. Switch off the electrosurgical generator by pressing the power switch. ►...
Page 84: Reprocessing Of The Esg-410
Reprocessing of the ESG-410 10 Reprocessing of the ESG‑410 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.
Page 85: Reprocessing Of Other Hf Equipment
Reprocessing of the ESG-410 Inspection before disinfection ● Visually inspect the product thoroughly after cleaning. The product must be visually clean. ● If there are any signs of debris, repeat the cleaning process. Disinfection procedure 1. Take a soft, lint-free cloth that has been soaked with a suitable disinfectant.
Page 86: Maintenance
Be aware that fuses must only be changed by an authorized service center. 11.1 Regular safety checks To ensure electrical safety and to maintain device performance, Olympus recommends to perform a safety check annually or according to national regulations and guidelines on all medical electrical equipment.
Page 87: Maintenance Settings
11.2.1 Data transfer This function allows to export or import data to or from an USB flash drive that is connected to the rear of the ESG-410. Export of settings The currently selected settings, except for the Baby neutral electrode setting and the Autostart delay setting, are transferred to the USB flash drive.
Page 88 ‒ All settings are loaded from the USB flash drive. ‒ All user-defined procedures are loaded from the USB flash drive. Be aware that all user-defined procedures that are currently stored on the ESG-410 are deleted, when importing settings from a USB flash drive.
Page 89 Maintenance 11.2.6 Maintenance reminder This function allows to set a date on which the electrosurgical generator reminds the user that the next regular safety check is due. When the due date is reached then the maintenance reminder indicator is displayed on the top left of the touchscreen.
Page 90 ‒ Descending tone sequence ‒ Constant tone sequence. This is the default setting. For more information refer to the section “17.2.2 Activation tones for bipolar modes” on page 102. This function is password protected. To receive the password contact Olympus.
Page 91 Maintenance 11.2.12 Service This function is for service purposes only.
Page 92: Repair And Shipment
Repair and shipment 12 Repair and shipment Consider the following information if the ESG-410 needs to be repaired or shipped to Olympus. 12.1 Repair Authorized service centers Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus.
Page 93: Storage And Disposal
Storage and disposal 13 Storage and disposal This chapter provides information on the following: ‒ Storage of the electrosurgical generator ‒ Disposal of the electrosurgical generator 13.1 Storage To prevent damage of the electrosurgical generator and the foot switch during storage, observe the following: ‒...
Page 94: Ordering Information
Description Catalog number Adapter MAJ-1873 for UHI-2/3 N3809530 Communication cable MAJ-1871, 0.25 m N3809330 Communication cable MAJ-1872, 10 m N3809430 Electrosurgical generator ESG-410 WA91307W Energy cart TC-E410 K10030281 Foot switch, double pedal WA91301W Foot switch, double pedal, wireless WA91302W Foot switch, singe pedal WA91303W HF cable MAJ-860, monopolar, 3.5 m, pin diameter: 8 mm...
Page 95: Compatible Equipment
Compatible equipment 15 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 96: Compatible Neutral Electrodes
Compatible equipment ESG-410 UNIVERSAL 1 BIPOLAR UNIVERSAL 2 MONOPOLAR 1 MONOPOLAR 2 NEUTRAL WA91301W ESG-410 TC-E410 WA91302W MAJ-1871 MAJ-1872 WA91303W MAJ-1873 UHI-2 ¹) MAJ-860 UHI-3 MAJ-814 UHI-4 WA99510A ¹) Monopolar and bipolar HF instruments, also refer to section “8.2 Description of the output sockets”...
Page 97 Compatible equipment 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 98: Compatible Foot Switches
Compatible equipment Manufacturer Neutral electrode description Model Covidien Patient weight 2.7...13.6 kg E7510-25, E7510-25DB* *Not licensed in accordance with Canadian law. 15.3 Compatible foot switches Description Catalog number Foot switch, double pedal WA91301W Foot switch, double pedal, wireless WA91302W Foot switch, single pedal WA91303W...
Page 99: Technical Data
Technical data 16 Technical data 16.1 Specifications for the ESG-410 Size Width ........................370 ± 2 mm Height ........................241 ± 2 mm Depth ........................501 ± 2 mm Depth including connected cables ...............520 ± 10 mm Weight ........................... 16.4 kg Weight of packaging ...................... 2.48 kg Power supply Voltage range ..............
Page 100: Plug Requirements
2-pin plugs ................Pin∅ 4 mm, pin spacing 22 mm Coaxial plugs....................... Pin∅ 4/8 mm For the UNIVERSAL output sockets Suitable for special Olympus instruments with instrument recognition For the neutral electrode socket 2 pin plugs ................∅ 2.5 mm, 10 mm pin spacing 16.4 Resistance range for CQM...
Page 101: Additional Information
Additional information 17 Additional information This chapter contains: ‒ Additional specifications for the alarm systems like log file and alarm priorities ‒ Information on alarm tones and activation tones ‒ Description of mode characteristics (acc. to IEC 60601-2-2) ‒ Output characteristic diagrams 17.1 Alarm system An alarm condition is indicated about 1 second after detection and securing.
Page 102: Tone Information
Additional information E1629, E1631-E1659, E1662-E1665, E1667-E1672, E1758, E1759, E1761-E1764, E1771, E1773-E1777, E1783, E1784, E1788-E1790, E1792, E1799, E1800, E1803, E1804, E1811-E1817, E1820, E1821, E1823-E1837, E1839-E1845, E1848-E1851, E1856-E1858, E1860-E1863, E1875, E1876, E1878, E1880, E1881, E1884, E1892-E1902, E1906-E1908, E1911, E1913-E1918, E1922, E1925, E1934-E1937, E1943-E1946, E1949-E1953, E1956, E1957, E1959-E1961, E1965, E1980, E1981, E1990, E1991, E2024, E2025, E2036-E2041, E2050, E2051, E2053, E2062-E2065, E2071-E2073, E2078, E2079, E2082, E2090, E2093, E2095, E2099, E2106, E2108, E2115, E2116, E2118, E2120-E2126, E2128-E2132, E2135,...
Page 103 Additional information Mode name Tone sequence Description BipolarCut Constant tone pitch Continuous tone during cutting. PlasmaCut at 554 Hz PK PureCut PK SoftCut PK LoopCut Constant tone pitch Continuous tone during cutting. PK MorceCut at 554 Hz In case of short circuit: Intermittent tone with 300 ms on time and 150 ms off time.
Page 104 Additional information Mode name Tone sequence Description PK Coag 5 descending tone Continuous tone with intermittent start tone. The tone sequence Descending pitches, resistance changes its tone pitch stepwise in relation to tissue resistance. dependent The higher the tissue resistance, the lower the tone pitch. This tone sequence allows the user to monitor the coagulation Amplitude progress if the visibility of the application area is limited by the...
Page 105: Mode Characteristics According To Iec 60601-2-2
Fulgurate 440 Hz PowerCoag SoftCoag Spray SprayCoag 17.2.4 Other tones Startup tone (Olympus jingle) Duration......................... 0.375 s Frequency ....................500/1000/2000 Hz Volume .................... ≥ 65 dB(A), not adjustable Touch tone Duration........................... 0.09 s Frequency ........................500 Hz Volume .................... ≥ 65 dB(A), not adjustable 17.3 Mode characteristics according to IEC 60601‑2‑2...
Page 106: Characteristics Of High Power Cut Support (Hpcs)
Additional information 17.4 Characteristics of High Power Cut Support (HPCS) The following is an example of the characteristics of HPCS during PulseCut mode: Spark Spark COAG time 17.5 Output characteristic diagrams The following diagrams show the HF output data for each mode. Graph color: Black Green...
Page 107 Additional information 17.5.1 Monopolar modes Blend 1000 10000 Load [Ohm] Power level 2500 2000 1500 1000 Power level...
Page 108 Additional information BlendCut 1000 10000 Load [Ohm] Power level 1600 1400 1200 1000 100 120 140 160 180 200 Power level...
Page 109 Additional information FineCut 1000 10000 Load [Ohm] Power level...
Page 110 Additional information PowerCut 1000 10000 Load [Ohm] Power level...
Page 111 Additional information PulseCut Fast 1000 10000 Load [Ohm] Power level...
Page 112 Additional information PulseCut Slow 1000 10000 Load [Ohm] Power level...
Page 113 Additional information Pure 1000 10000 Load [Ohm] Power level Power level 1400 1200 1000 Power level...
Page 114 Additional information PureCut 1000 10000 Load [Ohm] Power level...
Page 115 Additional information Fulgurate 1000 10000 Load [Ohm] Power level 4000 3500 3000 2500 2000 1500 1000 Power level...
Page 116 Additional information ForcedCoag 1000 10000 Load [Ohm] Power level...
Page 117 Additional information PowerCoag 1000 10000 Load [Ohm] Power level...
Page 118 Additional information SoftCoag 1000 10000 Load [Ohm] Power level...
Page 119 Additional information Spray 1000 10000 Load [Ohm] Power level...
Page 120 Additional information SprayCoag 1000 10000 Load [Ohm] Power level...
Page 121 Additional information 17.5.2 Bipolar modes BipolarCut 1000 10000 Load [Ohm] Power level...
Page 122 Additional information PlasmaCut 1000 10000 Load [Ohm] Power level...
Page 123 Additional information PK LoopCut 1000 10000 Load [Ohm] Power level...
Page 124 Additional information PK MorceCut 1000 10000 Load [Ohm] Power level...
Page 125 Additional information PK PureCut 1000 10000 Load [Ohm] Power level...
Page 126 Additional information PK SoftCut 1000 10000 Load [Ohm] Power level...
Page 127 Additional information AutoCoag 1000 10000 Load [Ohm] Power level...
Page 128 Additional information BiSoftCoag 1000 10000 Load [Ohm] Power level...
Page 129 Additional information HardCoag Power level...
Page 130 Additional information PK Coag 1000 10000 Load [Ohm] Power level...
Page 131 Additional information PK SoftCoag 1000 10000 Load [Ohm] Power level...
Page 132 Additional information SalineCoag 1000 10000 Load [Ohm] Power level...
Page 133: Electromagnetic Compatibility
The essential performance requirement according to IEC 60601-1 is not applicable to the ESG-410. Basic safety is the performance requirement used during immunity testing.
Page 134 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 135 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 136: Glossary
Glossary 19 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 137 Glossary To give a reliable statement on the effect that the height of a crest factor has, it is necessary to distinguish if a cutting mode or a coagulation mode is used. For cutting modes it can be said, that the higher the crest factor is, the higher is the thermal effect on the tissue (including coagulation depth).
Page 138 Glossary Abbreviation for high frequency. Refer to the glossary entry “High frequency”. HF instrument Instrument that applies HF current for electrosurgical procedures, also called electrosurgical instrument. HF output Energy that is provided by the electrosurgical generator. High frequency (HF) Frequencies of alternating current above 100 kHz. High frequencies are used in electrosurgery, as lower frequencies provoke excessive neuromuscular stimulation and perhaps electrocution.
Page 139 Glossary Split type neutral electrode With a split type neutral electrode, the conductive layer is split in 2 or more areas. If a part of such a neutral electrode detaches from the patient’s skin, then the electric circuit is broken. This condition is detected by the contact quality monitor (CQM), which causes the electrosurgical generator to stop the output of HF current.
Page 140: Index
Index 20 Index Activation tones, for bipolar modes .....................102 Activation tones, for monopolar modes ....................104 Alarm priorities ..........................77, 101 Alarm tones ............................102 All zero..............................41 Asterisk before procedure name ......................42 AutoCoag ...............................57 AutoCoag, Autostop..........................76 Autostart ..............................76 Autostart, BiSoftCoag ..........................57 Autostop ..............................76 Autostop, AutoCoag..........................57 Autostop, HardCoag ..........................57 Baby neutral electrodes .........................46...
Page 141 Index Delete procedure ...........................88 Direct coupling ............................18 Disinfection ............................84 Earth leakage currents ..........................17 Effects on tissue ............................62 Electric circuit ............................15 Electric current and biological tissue .....................13 Electromagnetic considerations for placement ..................30 Error log ..............................88 Error message ............................25 Error messages .............................77 Error messages, table ...........................81 Event log ..............................88 Everest instruments ..........................66...
Page 142 Neuromuscular stimulation ......................13, 52, 138 Neutral electrodes ..........................16 Non-split neutral electrode setting ......................88 Non-split type neutral electrodes ......................44 NOTICE, signal word ..........................8 Olympus jingle .............................105 Pacemakers ............................16 Patient target group ..........................9 Physiological monitoring equipment ......................17 PK Coag ..............................58 PK Coag tones ............................90 PK instruments ............................66...
Page 143 Index PureCut ..............................60 Rear panel .............................22 Regular safety checks ...........................86 Reset to defaults ............................90 Resistances in tissue types ........................13 SalineCoag ............................58 Set screen .............................24 Smoke ..............................12 SoftCoag ...............................61 Software update ............................89 Software version ............................89 Split type neutral electrodes ........................44 Spray ..............................61 SprayCoag .............................61 Startup settings .............................41 Startup tone ............................105...
Page 144 Index...

Olympus ESG-410 Instructions For Use Manual

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