Generator G11 Operators Manual sw ver 2018-1.X July 2018 PDF download

Generator G11 (GEN11) Operator’s Manual

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Generator G11 Operator’s Manual Table of Contents Overview�� 1

Standard Conventions Used��1

Chapter 1 - General Information�� 1

Indications��1 Contraindications��1 Device Description��1 How Supplied��1 Illustration and Nomenclature��2 General Warnings��3 General Cautions��4 Customer Service��4

Chapter 2 - Instructions for Use - Harmonic® Devices�� 5

Setup��5 Ready Screen Features��6 Operation��7 Settings��7 Warning��8

Chapter 3 - Instructions for Use - EnSeal® Devices�� 9

Setup��9 Ready Screen Features��10 Operation��10 Settings��11

Chapter 4 - Troubleshooting and Screen Guide�� 12

General Troubleshooting��12 Harmonic Troubleshooting��13 EnSeal Troubleshooting��16 Screen Guide��17

Chapter 5 - Cleaning, Disinfection, Preventive Maintenance and Repair�� 23 Electrical Safety Checks��23 Cleaning and Disinfection Instructions��23 Maintenance and Repair��26 Disposing of Ethicon Endo-Surgery Generator G11 (Environmental Protection)��26

Chapter 6 - Conformance to Standards�� 26 Appendix�� 27 System Specifications��27 Electromagnetic Compatibility (EMC)��28 Symbols��30

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Generator G11 Operator’s Manual Overview Please read all information carefully. Failure to properly follow the instructions may lead to serious surgical consequences. This manual contains important information for operation of GEN11. It should be kept where it may be referenced during usage, especially for screen translations. Print or copy pages as necessary to keep nearby. Important: T his manual is designed to provide instructions for use of the Generator G11. It is not a reference to surgical techniques. Go to www.e-ifu.com for the latest version of this manual. Harmonic® and EnSeal® are trademarks of Ethicon Endo-Surgery.

Standard Conventions Used The Use of Caution, Warning, 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 Caution, a Warning, or a Note statement. These statements are found throughout the documentation. These statements should be read before continuing to the next step in a procedure. Warning: A Warning statement indicates an operating or maintenance procedure, practice, or condition that, if not strictly observed, could result in personal injury or loss of life. Caution: A Caution statement indicates an operating or maintenance procedure, practice, or condition that, if not strictly observed, could result in damage to or destruction of the equipment. Note: A Note statement indicates an operating or maintenance problem, practice, or condition that is necessary to accomplish a task efficiently.

Chapter 1 - General Information Indications The Generator G11 provides radiofrequency power to drive EnSeal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. EnSeal and Harmonic instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. 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.

•

The instruments 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 a unique receptacle port that accepts either a Harmonic or an EnSeal device. Connectors (HGA11 for Harmonic and EGA11 for EnSeal) are used to enable the generator to power legacy devices.

How Supplied The Generator G11 is supplied in a semi-ready-to-use state. The shipping box contains the Generator G11, power cord and user manual. The disposable Ethicon Endo-Surgery EnSeal or Harmonic instruments are not included in this packaging and must be purchased separately. The Harmonic device connector (HGA11), EnSeal device connector (EGA11), footswitch (FSW11) and cart (CRT11) are also available separately.

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Generator G11 Operator’s Manual Illustration and Nomenclature Front Panel of the Generator

Figure 1 1

POWER ON/OFF SWITCH

Glows green when the generator is powered up.

2

DISPLAY/TOUCH SCREEN

Displays system information and serves as interface for adjusting controls and settings.

3

CONNECTOR/ DEVICE RECEPTACLE

Receptacle used to attach the connectors or devices to the generator.

Back Panel of the Generator

Figure 2 4

POWER CORD RECEPTACLE

Receptacle used to attach the power cord 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 conductor.

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Generator G11 Operator’s Manual Footswitch

Figure 3 7

MIN (LEFT PEDAL)

Activates power for EnSeal or minimum power for Harmonic.

8

MAX (RIGHT PEDAL)

Activates maximum power for Harmonic.

General Warnings •

Verify that the unit is fully operational prior to administering power output for tissue sealing.

•

This equipment is for use only by qualified medical personnel trained in the use of ultrasonic surgery or electrosurgery. Inappropriate use of the equipment by untrained medical personnel may result in hazardous electrical output.

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Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen as explosion may occur.

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Non-flammable agents should be used for cleaning and disinfection wherever possible. Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of HF surgery. There is a risk of pooling of flammable solutions under the patient in body depressions such as the umbilicus, and in body cavities such as the vagina. Any fluid pooled in these areas should be mopped up before the electrosurgery. Attention should be called to the danger of ignition of endogenous or other flammable gases. Some materials, for example cotton and gauze, when saturated with oxygen may be ignited by sparks produced in normal use during electrosurgery.

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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.

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Do not operate the unit in close proximity to volatile solvents such as methanol or alcohol as explosion may occur.

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Avoid use of Generator G11 adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, monitor the Generator G11 and the other equipment to assure normal operation.

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Interference produced by the operation of high-frequency surgical equipment may adversely affect the operation of other electronic medical equipment such as monitors and imaging systems.

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Check if the patient has a pacemaker or implanted cardioverter/defibrillator. Consult the pacemaker or implanted cardioverter/defibrillator manufacturer for information about the effects of radiofrequency energy on these devices.

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Use of accessories and cables other than those specified may result in unpredictable performance, increased electromagnetic emissions, or decreased electromagnetic immunity. No customer modification of this equipment is allowed; modification of this equipment could have a negative impact on electrical safety and electromagnetic emissions.

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No internal user serviceable parts. For service, return the generator to an authorized Ethicon Endo-Surgery service facility.

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To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.

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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 access to these points are kept clear.

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This device is not MR safe and is not MR compatible.

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This device seals vessels up to a maximum diameter of 7 mm depending on the instrument used. Refer to the instrument IFU for further information.

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Generator G11 Operator’s Manual •

As with all energy sources (Electrosurgery, Lasers, or Ultrasound) there are concerns about the carcinogenic and infectious potential of the by-products such as tissue smoke plume and aerosols. Appropriate measures such as protective eyewear, filtration masks, and effective smoke evacuation equipment should be used in both open and laparoscopic procedures.

•

In case of system failure, ensure availability of the appropriate backup equipment relevant to the specific procedure.

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After removing the instrument, examine the tissue for hemostasis. If hemostasis is not present, appropriate techniques should be used to achieve hemostasis.

General Cautions •

The touch screen display of the generator is very sensitive. Do not use sharp metal objects on the touch screen.

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Removing bottom screws or opening of this device invalidates the warranty and could create hazardous condition.

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Read instructions prior to use and follow the hospital’s clinical practice guidelines for ultrasonic surgery, electrosurgery, gynecology and laparoscopic procedures.

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Replace fuses only with the appropriate type and rating. See System Specifications.

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Do not sterilize the Generator G11. Sterilization will damage the unit.

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Do not restrict the openings on the bottom and the back panel of the Generator G11, as they provide the required airflow for cooling.

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If electromagnetic interference with other equipment is suspected, reorient the device or remove possible sources of interference (for example, cellular phones, radios, etc.) from the room.

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Monitoring electrodes should be placed as far as possible from the disposable device tips when high frequency surgical equipment and physiological monitoring equipment are used simultaneously. Monitoring systems incorporating high frequency current-limiting devices are recommended for use.

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Needle monitoring electrodes are not recommended.

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Activation of a radiofrequency device when not in contact with target tissue or in a position to deliver energy may cause capacitive coupling.

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The patient should not come in contact with metal parts which are earthed (grounded) or which have appreciable capacitance to earth (for example operating table supports, etc.).

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Cables to the surgical electrodes should be positioned so that contact with patient or other leads is avoided.

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CRT11 is recommended if Generator G11 is moved out of the operating room. Maintain control of the generator and cart when moving over thresholds.

Customer Service Warranty This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Ohio, U.S.A. Ethicon Endo-Surgery warrants this product to be free from defects in material and workmanship under normal use and preventive maintenance for the respective warranty period shown below. Ethicon Endo-Surgery’s obligation under this warranty is limited to the repair or replacement, at its option, of any product, or part thereof, which has been returned to Ethicon Endo-Surgery or its distributor within the applicable time period shown below and which examination disclosed, to Ethicon Endo-Surgery’s satisfaction, to be defective. This warranty does not apply to any product, or part thereof, that has been: (1) adversely affected due to use with devices manufactured or distributed by parties not authorized by Ethicon Endo-Surgery (2) repaired or altered outside Ethicon Endo-Surgery’s factory in a way so as to, in Ethicon Endo-Surgery’s judgement, affect its stability or reliability, (3) subjected to improper use, negligence or accident, or (4) used other than in accordance with the design and use parameters, instructions and guidelines for the product or with functional, operational or environmental standards for similar products generally accepted in the industry. Ethicon Endo-Surgery’s products are warranted for the following periods after delivery to the original purchaser: Generator and power cord

One (1) year, parts and labor

Footswitch

One (1) year, parts and labor

Cart

One (1) year, parts and labor

UNLESS SUPERCEDED BY APPLICABLE LOCAL LAW, THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF ETHICON ENDO-SURGERY AND IS A PURCHASER’S EXCLUSIVE REMEDY. IN NO EVENT SHALL ETHICON ENDO-SURGERY BE 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. Ethicon Endo-Surgery neither assumes

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Generator G11 Operator’s Manual 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. There are no warranties that extend beyond the terms hereof. Ethicon Endo-Surgery reserves the right to make changes to products built and/or sold by them at any time without incurring any obligation to make the same or similar changes on products previously built and/or sold by them.

Customer Service Contact the Ethicon Endo-Surgery Customer Service Department or your local representative for any customer or technical support. Call 1-800-USE-ENDO (1-800-873-3636) in the U.S. only.

Chapter 2 - Instructions for Use - Harmonic Devices Setup Caution: Do not block the air vents of the generator to avoid generator overheating. 1

Examine the Generator G11 and the Harmonic device for damage. Do not use damaged devices.

2

Secure the generator on its cart or any other suitable fixture in the appropriate position.

3

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.

4

Connect the footswitch connector to the footswitch receptacle 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 device directly to the Generator G11 receptacle.

Figure 4 •

If the plug looks like the image below, use the connector as an interface between the device and the generator.

Figure 5 Caution: Verify that the generator is secured to the cart or any other suitable fixture before powering up.

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Generator G11 Operator’s Manual 6

Turn on the generator using the On/Off switch on the front panel of the generator.

7

The green standby indicator illuminates and the system will run its initiation sequence. A tone is heard during the initiation sequence. When the initiation sequence is complete the test prompt screen appears.

8

Follow the instructions on the screen to run the test.

9

The Harmonic ready screen appears and the generator is ready for use.

Ready Screen Features The Harmonic ready screen has the following features:

2

5

Settings

1

3

6

4

7

Figure 6 1

SETTINGS

Touch this button to go to the system settings.

2

DEVICE SPECIFICATION

Indicates the device in use.

3

MIN

Indicates the user-adjustable minimum power level setting. When this power level is activated (by footswitch or handswitch), the ‘MIN’ indicator will flash. The system defaults to ‘MIN’ power level 3. Refer to the individual instrument package inserts for the recommended minimum power level.

4

MAX

Indicates the maximum power level setting. This setting is always 5. When this power level is activated (by footswitch or handswitch) the ‘MAX’ indicator will flash.

5

POWER LEVEL INCREASE

Touch this button to increase the minimum (MIN) power setting to the desired level (from 1 to 5). The level chosen will be shown on 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 chosen will be shown on the screen. The power level may be adjusted when the generator is ready.

7

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.

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Generator G11 Operator’s Manual Operation Minimum or maximum power is activated from the Harmonic device or from the footswitch. Use the left pedal on the footswitch for activating minimum power and use the right pedal for maximum power. During minimum activation, the MIN area on the generator screen will glow green and pulse. During maximum activation the MAX area will glow green and pulse. As the power is activated, audio feedback is initiated. The default power level value is 3 for the minimum. Touch the power level increase or the power level decrease button to increase or decrease the level of power to be generated in this mode. 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 7.

Shutdown Turn off the generator using the On/Off switch on the front panel of the unit. The shutdown sequence cannot be initiated during power activation. During shutdown, the generator clears 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 to make adjustments in the system settings 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. Touch the close button ‘X’ to exit from anywhere within the Settings menu. Touch the back arrow to go to the previous menu from the submenu screens. Settings Display Brightness Hand / Foot Activation Language Hand Piece Test System Information

Figure 7

Display Brightness Select ‘Display Brightness’ to see a preview of the ready screen while adjusting the brightness. Touch the plus or minus button to adjust the brightness. Touch the back arrow or close button after adjusting the settings to exit. Once a new brightness setting is selected that setting becomes the new system default.

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.

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Generator G11 Operator’s Manual A dot is used to indicate the current setting while a green glow highlights the current selection. 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 six 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. Touch the desired option, a confirmation screen will appear. Select ‘OK’ to confirm the language selection or ‘Cancel’ to cancel the language change.

Hand Piece Test Select ‘Hand Piece Test’ to check if the hand piece is functioning properly by installing a test tip and running the test with no instrument attached. Screen instructions and results are given for the specific hand piece to be tested.

System Information Select ‘System Information’ to see the high-level information about the generator and the device currently connected to the generator. The hospital staff can use the information to determine if a new hand piece should be ordered. The screen will also allow determination of the currently installed generator software revision.

Biomed Information ‘Biomed Information’ allows the technicians to access information about each error that has occurred on the generator and allows access to a ‘Biomed Mode’ display that streams data during instrument use. Touch the back arrow or close button to exit.

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. As a result, the user should use caution with the blade, clamp arm, and distal part of the shaft as they may exhibit an elevated temperature. Additional temperature information may be contained in individual instrument instructions for use.

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Generator G11 Operator’s Manual Chapter 3 - Instructions for Use - EnSeal Devices Setup Caution: Do not block the air vents of the generator to avoid generator overheating. 1

Examine the Generator G11 and the EnSeal device for damage. Do not use damaged devices.

2

Secure the generator on its cart or any other suitable fixture in the appropriate position.

3

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.

4

Connect the footswitch connector to the footswitch receptacle on the back panel of the generator if applicable.

5

Connect the EnSeal tissue sealing device to the Generator G11. Refer to instrument instructions for use. •

If the plug looks like the image below, connect the device directly to the Generator G11 receptacle.

Figure 8 •

If the plug looks like the image below, use the connector as an interface between the device and the generator.

Figure 9 Caution: Verify that the generator is secured to the cart or any other suitable fixture before powering up. 6

Turn on the generator using the On/Off switch on the front panel of the generator.

7

The green standby indicator illuminates and the system will run its initiation sequence. A tone is heard during the initiation sequence. When the initiation sequence is complete the EnSeal ready screen appears and the generator is ready for use.

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Generator G11 Operator’s Manual Ready Screen Features The EnSeal ready screen has the following features:

2

Ready

Settings

1

3

4

Figure 10 1

SETTINGS

Used to go to the system settings.

2

DEVICE SPECIFICATION

Indicates the device in use.

3

READY

System ready display.

4

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.

Operation Power is activated from the EnSeal device or from the left pedal of the footswitch. The EnSeal device has only one mode of operation. There are no power level settings. When power is 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 upper impedance threshold has been reached and the knife has been fully advanced (handle is fully closed), a single tone sounds, indicating a complete cycle. Always advance the knife under power. The single tone for a complete cycle is the only indication of a complete cycle and cut.

Volume Adjust the volume using the plus or minus button. Default volume setting is 7.

Shutdown Turn off the generator using the On/Off switch on the front panel of the unit. The shutdown sequence cannot be initiated during power activation. During shutdown, the generator clears content from the screen and displays the shutdown animation.

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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. Touch the close button ‘X’ to exit from anywhere within the Settings menu. Touch the back arrow to go to the previous menu from the submenu screens. Settings Display Brightness Hand / Foot Activation Language System Information Biomed Information

Figure 11

Display Brightness Select ‘Display Brightness’ to see a preview of the ready screen while adjusting the brightness. Touch the plus or minus button to adjust the brightness. Touch the back arrow or close button after adjusting the settings to exit. Once a new brightness setting is selected that setting becomes the new system default.

Hand / Foot Activation Select the handswitch activation or 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. 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 six 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. Touch the desired option, a confirmation screen will appear. Select ‘OK’ to confirm the language selection or ‘Cancel’ to cancel the language change.

System Information Select ‘System Information’ to see the high-level information about the generator and the device currently connected to the generator. The screen will also allow determination of the currently installed generator software revision.

Biomed Information ‘Biomed Information’ allows the technicians to access information about each error that has occurred on the generator.

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Generator G11 Operator’s Manual Chapter 4 - Troubleshooting and Screen Guide General Troubleshooting Informative 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.

Alarm System The Generator G11 includes integrated diagnostics that monitor the operation of the generator and accessories and flash either informative screens or alarms with no delay. In addition to audible alarm sounds, the display of alarms on the front panel is easily observable by the surgeon or nursing staff from the surgical field. All alarms are technical alarms and are based on electrical parameters. There are no physiological alarms that are produced by the Generator G11. Alarm settings are not adjustable by the operator nor can priority be reassigned. Alarm settings also do not adjust to operator inputs nor do they change through power loss. The Power on Self Test (POST) verifies that the generator is operational. Since the alarms are integrated into the software algorithms responsible for running the appropriate instruments, the POST also verifies alarm operation. Therefore, a separate test for verifying the alarm output is not required. During the POST an audio tone is emitted from the generator so 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 discontinues activation of the instrument. Alarms and other events are logged in the generator. The log is retained after power is removed and is accessed through the biomed screen. There is no reminder signal.

Audio Sound Pressure Levels •

Medium level alarms: Greater than 75 dBA (not adjustable)

•

Low level alarms: Within 70 - 75 dBA (not adjustable)

Alarm Definitions The following alarm priorities are used for the Generator G11. All alarms stop generator output and high priority alarms will take precedence over lower priority alarms. Only one alarm will be displayed at a time since any alarm stops output. Low Priority Alarms Requires surgical staff attention for continued, efficient procedural progress. A low priority issue will not generally progress to a hazardous condition even if not addressed promptly but it must be addressed to continue the procedure. The screen shows a solid yellow background with a low priority alarm symbol. A two-tone audio alarm sound accompanies a low priority alarm. Medium Priority Alarms Requires prompt surgical staff attention to reduce or mitigate a hazardous condition. Ignoring this alarm can result in a serious injury or death. The screen shows a solid yellow background with a flashing medium priority alarm symbol. A three-tone audio alarm sound accompanies a medium priority alarm. High Priority Alarms There are no high priority alarm conditions in Generator G11. The following are the general low priority alarms: Visual Alarms

Reactivate Two switch activations detected: HANDSWITCH FOOTSWITCH

Description

Troubleshooting Steps

Two activation switches are closed in the system. This may be due to a stuck switch or the inadvertent closure of an additional switch.

Reactivate instrument to continue. If the surgical staff has activated only one switch, replace the instrument or footswitch that may have the stuck switch.

Reactivate instrument to continue.

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Generator G11 Operator’s Manual A system reset is required.

Remove the instrument from the incision and cycle the generator power using the Power On/Off switch on the front of the panel. If problem persists, please send the generator to an authorized Ethicon Endo-Surgery service 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 Endo-Surgery service center.

Indicates an internal error with the cooling fans of the generator.

Please send the generator to an authorized Ethicon Endo-Surgery service center.

The generator is overheating.

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 Endo-Surgery service facility.

The device requires a generator software upgrade.

Contact your Ethicon Endo-Surgery representative for a software upgrade.

Any general issue with the system.

Contact your Ethicon Endo-Surgery representative.

Restart Generator Restart generator to reset system and continue. If problem persists, please contact your EES representative.

Press OK to Continue Press OK to reset system and continue. If problem persists, please contact your EES representative. OK

Please Contact Your EES Representative Cooling fan error detected.

Generator Overheating Remove any obstructions from air vents.

Software Upgrade Required to Run Device Please contact your EES representative

Please contact your EES representative

Harmonic Troubleshooting Note: The following alarms are specific to Harmonic devices used with Generator G11.

Alarms The Generator G11 supports the following alarms to help in the identification and troubleshooting of component problems when using a Harmonic device. The following list is meant as an adjunct to, but not a substitute for clinical judgment and observation. Other than fuses, there are no operator-serviceable parts in the Generator G11. For replacement or service, contact the Ethicon Endo-Surgery Customer Service Department or your local representative.

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Generator G11 Operator’s Manual Visual Alarms

Description

Troubleshooting Steps

The hand piece has reached the end of life.

Replace the hand piece. Contact the Ethicon Endo-Surgery Customer Service Department (call 1-800-USEENDO (1-800-873-3636) in the U.S. only) or contact your local sales representative to discuss local waste disposal solutions and processes.

The hand piece has failed to perform the internal diagnostic routines and the generator will not be able to operate the hand piece reliably.

Replace the hand piece. Contact the Ethicon Endo-Surgery Customer Service Department (call 1-800-USEENDO (1-800-873-3636) in the U.S. only) or contact your local sales representative to discuss local waste disposal solutions and processes.

No Uses Remaining Replace hand piece.

Replace hand piece

The instrument has been loaded to the point where output has stopped.

Relax pressure on the instrument or reposition so there is less tissue in the 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 guided to remove the instrument from the incision before proceeding.

Remove the instrument from the incision. When the instrument is clear, touch the ‘Next’ button for further diagnostic guidance.

The Harmonic instrument may be damaged and cannot be activated.

Unplug the hand piece and replace the instrument.

Relax Pressure On Blade Reactivate instrument to continue.

Remove Instrument From Patient Next

Replace Instrument Blade error detected. Unplug hand piece and replace instrument.

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Tighten Assembly

The instrument may not be properly assembled to the hand piece.

Press the ‘Next’ button to continue. Re-tighten the instrument. Ensure that one hand is holding the appropriate torque wrench and the other hand is holding the hand piece (not the instrument).

If using shears, keep jaws of device open during test.

Press ‘Next’ to advance, to retry test with jaws open.

If using shears, keep jaws of device open during test.

Press ‘Next’ to advance, 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.

A system reset is required.

Reactivate instrument to reset system and continue.

Indicates an internal error with the identification circuitry in the instrument. Special circuitry is installed on certain advanced devices to identify the device to the generator and tailor the generator’s output to the device.

Unplug hand piece and replace instrument.

Note: If multiple instruments have indicated an instrument error on the same hand piece, try replacing the hand piece to ensure that the issue is related to the instruments.

Reactivate Reactivate instrument to reset system and continue

Replace Instrument Instrument error detected. Unplug hand piece and replace instrument.

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Generator G11 Operator’s Manual

Change hand piece Please contact your EES representative to screen current hand piece for errors. If problem persists, replace instrument.

Indicates an internal error that may be either with the hand piece or the instrument.

Change hand piece first. Please contact your EES representative to screen current hand piece for errors. If problem persists, unplug hand piece and replace instrument.

Change hand piece Please contact your EES representative to screen current hand piece for errors. If problem persists, replace instrument.

EnSeal Troubleshooting Note: The following alarms are specific to EnSeal devices used with Generator G11.

Alarms The Generator G11 supports the following alarms to help in the identification and troubleshooting of component problems when using an EnSeal tissue sealing device. The following list is meant as an adjunct to, but not a substitute for clinical judgment and observation. Other than fuses, there are no operator-serviceable parts in the Generator G11. For replacement or service contact the Ethicon Endo-Surgery Customer Service Department or your local representative. Visual Alarms

Reposition Jaws and Reactivate

Description Instrument is being activated on low impedance (thin) tissue or metal (such as staples, clips, retractors, or clamps).

Troubleshooting Steps Reposition the instrument jaws and reactivate.

Replace instrument The same alarm has triggered three times in a row. There may be an issue in the instrument.

Replace the instrument.

Replace instrument

Replace Instrument Instrument error detected.

Indicates an internal issue with the identification circuitry in the instrument. Special circuitry is installed on certain advanced devices to identify the device to the generator and tailor the generator’s output to the device.

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Replace the instrument.

Ethicon Inc

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Generator G11 Operators Manual sw ver 2018-1.X July 2018