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Generator G11 (GEN11)

Operator’s Manual

For use with Software Version 2016-1

Содержание Generator G11

Страница 1: ...Generator G11 GEN11 Operator s Manual For use with Software Version 2016 1...

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Страница 3: ...ctions for Use ENSEAL Instruments 13 Setup 13 Ready Screen Features 14 Operation 14 Settings 15 Chapter 4 Troubleshooting and Screen Guide 17 General Troubleshooting 17 HARMONIC Troubleshooting 19 ENS...

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Страница 5: ...Conventions Used The Use of WARNING Caution and Note Statements Information relative to the completion of a task in a safe and thorough manner will be supplied in the form of a WARNING a Caution or a...

Страница 6: ...ents are not indicated for incising bone Device Description The Generator G11 supplies energy to the HARMONIC and ENSEAL surgical instruments The generator uses a touchscreen display interface and has...

Страница 7: ...to the generator 5 FOOTSWITCH RECEPTACLE Receptacle used to connect the footswitch to the generator 6 POTENTIAL EQUALIZATION TERMINAL Provides means for connection to a potential equalization conducto...

Страница 8: ...osurgery Do not operate the Generator G11 in a moist environment as a shock hazard may exist If liquids have entered the Generator G11 the unit must be returned to the manufacturer for testing prior t...

Страница 9: ...idates the warranty and could create hazardous conditions Do not sterilize the Generator G11 Sterilization will damage the unit Do not restrict the openings on the bottom and the back panel of the Gen...

Страница 10: ...LIABLE FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING WITHOUT LIMITATION DAMAGES RESULTING FROM LOSS OF USE PROFITS BUSINESS OR GOODWILL OTHER THAN AS EXPRESSLY PROVIDED BY A SPECIFIC LAW...

Страница 11: ...le on the back panel of the generator if applicable 5 Connect the HARMONIC instrument to the Generator G11 If the plug looks like the image below connect the instrument directly to the Generator G11 r...

Страница 12: ...n the screen The power level may be adjusted when the generator is ready 6 POWER LEVEL DECREASE Touch this button to decrease the minimum MIN power setting to the desired level from 1 to 5 The level c...

Страница 13: ...2 INSTRUMENT SPECIFICATION Indicates the instrument in use 3 ADVANCED HEMOSTASIS Indicates the Advanced Hemostasis Mode if available on the connected instrument Min button of the footswitch is used t...

Страница 14: ...ears content from the screen informs the user if 10 or fewer hand piece uses remain for the attached hand piece and displays the shutdown animation Settings Basic Navigation Touch the Settings button...

Страница 15: ...our instrument has this feature Convert MIN to Adv Hemostasis Some instruments enable this menu option When this option is selected the MIN button will function as the Advanced Hemostasis Mode button...

Страница 16: ...and is intended to supply sufficient friction and shearing effect to cut and coagulate tissue in contact with the active blade Therefore use caution when handling the blade clamp arm and distal end of...

Страница 17: ...tswitch receptacle on the back panel of the generator if applicable 5 Connect the ENSEAL tissue sealing instrument to the Generator G11 Refer to instrument instructions for use If the plug looks like...

Страница 18: ...s activated audio feedback is initiated When the upper impedance threshold is reached and before the knife has been fully advanced the audio feedback changes into a higher pitch tone When both the upp...

Страница 19: ...s menu from the submenu screens Figure 12A Figure 12B Figure 12C Display Brightness Select Display Brightness to see a preview of the ready screen while adjusting the brightness Touch the plus or minu...

Страница 20: ...e is enabled and the instrument is being activated the generator will deliver energy for as long as 2 minutes Tone 3 Cycle Complete will not be received during an activation cycle while this mode is e...

Страница 21: ...the user can verify that the audio output is operational Visual output can also be verified through the start up screens Alarm audio cannot be paused but audio automatically ends when the user discont...

Страница 22: ...ce center A system reset is required Press OK to return to the state the system was in when the error occurred If problem persists please send the generator to an authorized Ethicon service center A g...

Страница 23: ...ervation Other than fuses the Generator G11 contains no operator serviceable parts For replacement or service contact the Ethicon Customer Service Department or your local representative Visual Alarms...

Страница 24: ...jaws Release the activation switch and reactivate the instrument to continue This screen is a prelude to further diagnostics To avoid inadvertent tissue damage during diagnostics the surgeon is guide...

Страница 25: ...to retry test with jaws open Indicates an internal error with the instrument that prevents it from being used Unplug the hand piece and replace the instrument Note If multiple instruments have indica...

Страница 26: ...icates an incompatible instrument Attach a compatible instrument Indicates an internal error that may be either with the hand piece or the instrument Change hand piece first Please contact your sales...

Страница 27: ...Visual Alarms Description Troubleshooting Steps Instrument is being activated on low impedance thin tissue or metal such as staples clips retractors or clamps Reposition the instrument jaws and react...

Страница 28: ...is starting up Instrument Not Found Plug in instrument to continue Note Press Settings for Settings Menu System Ready Note System startup is complete Hand Foot Activation Both handswitch and footswit...

Страница 29: ...ech Slovak Hungarian Language Hungarian Romanian Turkish Chinese Japanese Language Japanese Korean Language is now set to name of language Cancel to return to the previous language selected Identifyin...

Страница 30: ...ws during test Note Press Settings for Settings Menu Activate instrument for 2 seconds to run test If using shears open jaws during test Note Press Settings for Settings Menu Testing Note Running syst...

Страница 31: ...instrument sheath Note Press Next to advance Activate instrument outside patient to run test If using shears open jaws during test HARMONIC Settings Display Brightness Hand Foot Activation Language To...

Страница 32: ...Normally System Information Software Version Hand Piece Hand Piece Uses Remaining Tone Change ON OFF Tone Change ON Tone Change OFF Convert MIN to Advanced Hemostasis Default Activation Settings Conv...

Страница 33: ...Full Jaw Closure During Adv Hemostasis Advanced Features Are Not Available In This Instrument Adaptive Tissue Technology Regulated Energy Delivery Enhanced Audible Feedback Advanced Features Are Not A...

Страница 34: ...ll Jaw Closure Activation Cycle Timed Out Reactivate Note Cycle Complete was not reached Reactivate to continue Press Settings for Settings Menu ENSEAL Settings Display Brightness Hand Foot Activation...

Страница 35: ...y Note Reactivate with handswitch or adjust settings Press Settings for Settings Menu Extended Activation ON OFF Extended Activation OFF Extended Activation ON Extended Activation ON Activating ENSEAL...

Страница 36: ...directions 2 Use a soft clean cloth lightly moistened with the cleaning solution to manually clean the surfaces Pay special attention to cracks and crevices 3 Wipe thoroughly using a soft clean cloth...

Страница 37: ...infectant residuals are completely removed after wipe down If detergent or disinfectant residuals remain moisten a soft clean cloth with purified or deionized water and wipe down affected areas multip...

Страница 38: ...ch Isopropyl Alcohol 70 Sodium hypochlorite solutions 0 25 0 50 Cidex OPA Dispatch and Gigasept FF Disinfectants should be prepared and used according to the manufacturer s recommendations for use con...

Страница 39: ...for compatibility with other medical systems requiring such connections This conductor is not intended for protective earthing The software revision may be displayed on the biomed screen in the user i...

Страница 40: ...quipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests EN IEC 60601 2 2 Medical electrical equipment...

Страница 41: ...0 hPa Transport and Storage Conditions Temperature 35 C to 54 C Humidity 10 95 non condensing Atmospheric Pressure Range 700 hPa 1060 hPa Weight Generator 5 9 kg Cart 16 8 kg Footswitch 3 6 kg Overall...

Страница 42: ...nergy output without activation switch closure Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge IEC 61000 4 2 6kV Contact 8kV Air 6kV Co...

Страница 43: ...not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz a...

Страница 44: ...rating of the transmitter in watts W according to the transmitter manufacturer Note At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note These guidelines may not...

Страница 45: ...uct EIP has met the requirements set forth by the People s Republic of China for marking of EIPs and can be used during its environmental protection use period of 50 years After the environmental prot...

Страница 46: ...G11 42 Generator G11 Operator s Manual Manufacturer financially contributes to the cost of recovery and recycling Humidity Limitation Temperature Limit Low Alarm Medium Alarm Unit Quantity Alternatin...

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Страница 48: ...dt GERMANY GEN11 HGA11 EGA11 CRT11 FSW11 Rev 2015 11 30 A000031P01 ENG Ethicon Endo Surgery Inc 4545 Creek Road Cincinnati OH 45242 2839 USA 1 877 ETHICON 1 513 337 8901 English Ethicon Endo Surgery L...

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