G11 руководство пользователя

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  Generator G11 (GEN11) Operator’s Manual For use with Software Version 2016-1…
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• Page 3: Table Of Contents

  Chapter 5 — Cleaning, Disinfection, Preventive Maintenance and Repair ���������������������������������������������������������������������������� 32 Electrical Safety Checks �����������������������������������������������������������������������������������������������������������������������������������������32 Cleaning and Disinfection Instructions ������������������������������������������������������������������������������������������������������������������32 Maintenance and Repair �����������������������������������������������������������������������������������������������������������������������������������������35 Disposing of Ethicon Endo-Surgery Generator G11 (Environmental Protection) �������������������������������������������������35 Chapter 6 — Conformance to Standards ��������������������������������������������������������������������������������������������������������������������������������������� 36 Appendix ��������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 37 System Specifications ��������������������������������������������������������������������������������������������������������������������������������������������37…

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• Page 5: Overview

  Failure to properly follow the instructions may lead to serious surgical consequences� This manual contains important information for operation of the Generator G11� It should be kept where it may be referenced during usage, especially for screen translations� Print or copy pages as necessary to keep nearby�…

• Page 6: Chapter 1 — General Information

  Do not use these instruments for these procedures� Contraindications • The use of the Generator G11 and the attached instruments are contraindicated when, in the judgment of the physician, radiofrequency or ultrasonic surgery would be contrary to the best interest of the patient� •…

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  Generator G11 Operator’s Manual Back Panel of the Generator Figure 2 POWER CORD Receptacle used to attach the power cord to the generator� RECEPTACLE FOOTSWITCH Receptacle used to connect the footswitch to the generator� RECEPTACLE POTENTIAL Provides means for connection to a potential equalization conductor�…

• Page 8: General Warnings

  • 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 to use�…

• Page 9: General Cautions

  To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth� • To isolate the Generator G11 from supply mains power, disconnect the power cord either from the back panel of the generator or from the wall� Ensure that access to these points are kept clear�…

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  BUSINESS OR GOODWILL, OTHER THAN AS EXPRESSLY PROVIDED BY A SPECIFIC LAW� Ethicon Endo-Surgery neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Ethicon Endo-Surgery products�…

• Page 11: Chapter 2 — Instructions For Use — Harmonic Instruments

  Connect the power cord to the power cord receptacle on the back panel of the generator and to a grounded electrical outlet� The power requirements for the Generator G11 are listed on the label on the back panel of the generator�…

• Page 12: Ready Screen Features

  Generator G11 Operator’s Manual Ready Screen Features The HARMONIC ready screen has the following features: Figure 6A SETTINGS Touch this button to go to the system settings� INSTRUMENT Indicates the instrument in use� SPECIFICATION Indicates the user-adjustable minimum power level setting� When this power level is activated (by footswitch or handswitch), the ‘MIN’…

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  Generator G11 Operator’s Manual Note: Only the MIN power level setting is adjustable� The MAX power level setting is always set to 5� Volume Adjust the volume using the plus or minus button� Default volume setting is 5� Shutdown Turn off the generator using the On/Off switch on the front panel of the unit�…

• Page 14: Settings

  Generator G11 Operator’s Manual VOLUME Touch the plus or minus button to adjust the volume of the activation tones� A tone is heard to indicate the volume level selected� FOOTSWITCH Footswitch MIN & MAX are available when the footswitch is connected�…

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  Generator G11 Operator’s Manual Hand / Foot Activation Select the handswitch activation or the footswitch activation or both on the ‘Hand / Foot Activation’ screen during startup� This selection can be changed during use� A dot is used to indicate the current setting while a green glow highlights the current selection�…

• Page 16: Warning

  Generator G11 Operator’s Manual Warning The active blade of a HARMONIC instrument heats the tissue by friction 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 the shaft, as they may be hot�…

• Page 17: Chapter 3 — Instructions For Use — Enseal Instruments

  Connect the power cord to the power cord receptacle on the back panel of the generator and to a grounded electrical outlet� The power requirements for the Generator G11 are listed on the label on the back panel of the generator�…

• Page 18: Ready Screen Features

  Generator G11 Operator’s Manual Ready Screen Features The ENSEAL ready screen has the following features: Figure 11 SETTINGS Used to go to the system settings� INSTRUMENT Indicates the instrument in use� SPECIFICATION READY System ready display� VOLUME Touch the plus or minus button to adjust the volume of the activation tones� A tone is heard to indicate the volume level selected�…

• Page 19: Settings

  Generator G11 Operator’s Manual Settings Basic Navigation Touch the ‘Settings’ button to make adjustments in the system setup and access system information� The settings screen opens� Scroll down for further options� Note: If power is activated while in the Settings menu, the Settings window automatically closes and returns to the ready screen�…

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  Generator G11 Operator’s Manual Touch the back arrow or close button after adjusting the settings to exit� Language Select the preferred language from the options in the ‘Language’ screen� There are multiple language options, English being the default� Once the user selects and confirms the selection of a new language that language becomes the new system default�…

• Page 21: Chapter 4 — Troubleshooting And Screen Guide

  Informative Screens The user interface for the Generator G11 has a number of informative screens to guide the efficient use of the generator� Informative screens will maintain a consistent dark background to differentiate them from the alarm screens shown below�…

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  Remove any obstructions from the air vents at the back and bottom of the generator� If the air vents are not blocked and the problem persists return the generator to an authorized Ethicon service facility� The instrument requires a generator Contact your Ethicon sales representative for a software upgrade�…

• Page 23: Harmonic Troubleshooting

  Alarms The Generator G11 supports the following alarms to help in the identification and troubleshooting of component problems when using a HARMONIC instrument� The following list is meant as an adjunct to, but not a substitute for clinical judgment and observation�…

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  Generator G11 Operator’s Manual Replace the hand piece� Contact the The hand piece has failed to perform Ethicon Customer Service Department (call the internal diagnostic routines and the 1-877-ETHICON, +1-513-337-8901 (English) generator will not be able to operate the or contact your local sales representative to hand piece reliably�…
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  Generator G11 Operator’s Manual Press the ‘Next’ button to continue� Re-tighten the instrument� Ensure that one hand The instrument may not be properly is holding the appropriate torque wrench and assembled to the hand piece� the other hand is holding the hand piece (not the instrument)�…
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  Generator G11 Operator’s Manual Instrument error detected for integrated transducer instruments Indicates an incompatible instrument Attach a compatible instrument Change hand piece first� Please contact your Indicates an internal error that may sales representative to screen current hand piece be either with the hand piece or the for errors�…

• Page 27: Enseal Troubleshooting

  Alarms The Generator G11 supports the following alarms to help in the identification and troubleshooting of component problems when using an ENSEAL tissue sealing instrument� The following list is meant as an adjunct to, but not a substitute for clinical judgment and observation�…

• Page 28: Screen Guide

  Generator G11 Operator’s Manual Screen Guide General Screens Screen Description ETHICON (Note: Appears during system startup�) Starting Up (Note: System is starting up�) Instrument Not Found: Plug in instrument to continue� (Note: Press ‘Settings’ for Settings Menu�) System Ready (Note: System startup is complete�)

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  Generator G11 Operator’s Manual Language: Danish Dutch Portuguese Norwegian Greek Language: Greek Polish Czech 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�…
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  Generator G11 Operator’s Manual HARMONIC Screens Description Screen (Number of Uses) Remaining: Replace hand piece after (blank) uses� Activate instrument for 2 seconds to run test� If using shears, open jaws during test� (Note: Press ‘Settings’ for Settings Menu�) Activate instrument for 2 seconds to run test� If using shears, open jaws during test�…
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  Generator G11 Operator’s Manual Relax Pressure on Blade� (Note: Press ‘Settings’ for Settings Menu�) Clean Blade� Remove any tissue which may be lodged inside end of instrument sheath� (Note: Press ‘Next’ to advance�) Activate instrument outside patient to run test� If using shears, open jaws during test�…
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  Generator G11 Operator’s Manual Hand Piece Test� Assemble Test Tip to begin� (Note: Press ‘Test’ to run test�) Test Complete Test Complete Hand Piece Test Results: Hand Piece Test Results Hand Piece Uses Remaining HAND PIECE USES REMAINING Phase Margin…
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  Generator G11 Operator’s Manual HARMONIC ACE+ with Adv Hemostasis HARMONIC Shears with Advanced Hemostasis HARMONIC ACE+ with Adv Hemostasis Advanced Hemostasis Maintain Full Jaw Closure During Adv Hemostasis Advanced Features Are Not Available In This Instrument Adaptive Tissue Technology Regulated Energy Delivery…
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  Generator G11 Operator’s Manual ENSEAL Screens Screen Description Activating (Note: Power is being activated�) Cycle Complete (Note: Cut is complete� Press ‘Settings’ for Settings Menu�) Maintain Full Jaw Closure Activation Cycle Timed Out: Reactivate (Note: Cycle Complete was not reached� Reactivate to continue� Press ‘Settings’ for Settings Menu�)
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  Generator G11 Operator’s Manual Foot Activation Off: Ready (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 Display Brightness: Ready� System Information: Software Version…

• Page 36: Chapter 5 — Cleaning, Disinfection, Preventive Maintenance And Repair

  Before cleaning, thoroughly inspect the device(s) for any signs of damage, cracks, or improper mechanical function� Do not use the device(s) if there are signs of damage� Discard and replace device or send device to an authorized Ethicon service facility for repair where appropriate, if damage or degradation is present�…

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  Note: Disinfection with the listed chemicals may cause discoloration or wet spots on the central metallic post of the connector that interfaces with the Generator G11 receptacle� Discoloration or wet spots on the central metallic post of the connector should not affect the connector function�…
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  Generator G11 Operator’s Manual Footswitch (FSW11) Cleaning Note: Always keep the generator connector dry� Proceed with wipe-down cleaning as follows: 1� Prepare a neutral pH detergent or a neutral pH enzymatic detergent according to the manufacturer’s 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�…

• Page 39: Maintenance And Repair

  Disposing of Ethicon Endo-Surgery Generator G11 (Environmental Protection) The Generator G11 and accessories must not be disposed of at the end of life with other waste� To recycle waste equipment, obtain instructions from the Ethicon Customer Service Department (call 1-877-ETHICON, +1-513-337-8901 (English) or contact your local sales representative to discuss local waste disposal solutions and processes�…

• Page 40: Chapter 6 — Conformance To Standards

  Generator G11 Operator’s Manual Chapter 6 — Conformance to Standards The Generator G11 conforms to the following international standards: EN (IEC) 60601-1 (with Canadian and US Medical electrical equipment — Part 1: General requirements for basic safety and essential National Deviations)

• Page 41: Appendix

  Generator G11 Operator’s Manual Appendix System Specifications Main Fuses T5AL 250 V (Time-delay, 5 Amp, glass body, 5×20 mm package size, quantity: 2) Degree of Protection Against Electric Shock Type CF applied part consisting of the HARMONIC or ENSEAL instruments…

• Page 42: Electromagnetic Compatibility (Emc)

  The Generator G11 requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and used in accordance with the EMC information provided in this guide� The Generator G11 is intended for use in the electromagnetic environments specified below� Caution: Ensure that the Generator G11 is used only in these environments�…

• Page 43: Symbols

  Recommended separation distances between portable and mobile RF communications equipment and the Generator G11 The Generator G11 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled� The customer or the user of the Generator G11 can help prevent electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications equipment (transmitters) and the Generator G11 as recommended below, according to the maximum output power of the communications equipment�…

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  Generator G11 Operator’s Manual Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1�2 √P d = 1�2 √P d = 2�3 √P…
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  EIP should be recycled� Applicable in the People’s Republic of China� Fuse Product is certified by a Nationally Recognized Testing Laboratory� Consult the Generator G11 Operator’s Manual� GEN11 Refer to instruction manual/booklet for information related to safety� (Refer to blue symbol on the Generator G11)�…
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  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 Alternating Current Generator G11…
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  Ethicon Endo-Surgery (Europe) GmbH Hummelsbuetteler Steindamm 71 22851 Norderstedt GERMANY Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242-2839 USA 1-877-ETHICON +1-513-337-8901 (English) Ethicon Endo-Surgery, LLC ©Ethicon Endo-Surgery, Inc. 2015 475 Calle C Rev. 2015-11-30 A000031P01 ENG Guaynabo, PR 00969 USA…

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