Operators Manual
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Generator G11 (GEN11) Operator’s Manual For use with Software Version 2014-1
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Generator G11 Operator’s Manual Table of Contents Overview����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 1
Standard Conventions Used�������������������������������������������������������������������������������������������������������������������������������������1
Chapter 1 - General Information����������������������������������������������������������������������������������������������������������������������������������������������������� 2
Indications����������������������������������������������������������������������������������������������������������������������������������������������������������������2 Contraindications�����������������������������������������������������������������������������������������������������������������������������������������������������2 Device Description���������������������������������������������������������������������������������������������������������������������������������������������������2 How Supplied�����������������������������������������������������������������������������������������������������������������������������������������������������������2 Illustration and Nomenclature����������������������������������������������������������������������������������������������������������������������������������2 General Warnings�����������������������������������������������������������������������������������������������������������������������������������������������������4 General Cautions������������������������������������������������������������������������������������������������������������������������������������������������������5 Customer Service�����������������������������������������������������������������������������������������������������������������������������������������������������5
Chapter 2 - Instructions for Use - HARMONIC® Devices������������������������������������������������������������������������������������������������������������� 7
Setup�������������������������������������������������������������������������������������������������������������������������������������������������������������������������7 Ready Screen Features���������������������������������������������������������������������������������������������������������������������������������������������8 Operation������������������������������������������������������������������������������������������������������������������������������������������������������������������8 Settings�������������������������������������������������������������������������������������������������������������������������������������������������������������������10 Warning������������������������������������������������������������������������������������������������������������������������������������������������������������������12
Chapter 3 - Instructions for Use - ENSEAL® Devices����������������������������������������������������������������������������������������������������������������� 13
Setup�����������������������������������������������������������������������������������������������������������������������������������������������������������������������13 Ready Screen Features�������������������������������������������������������������������������������������������������������������������������������������������14 Operation����������������������������������������������������������������������������������������������������������������������������������������������������������������14 Settings�������������������������������������������������������������������������������������������������������������������������������������������������������������������15
Chapter 4 - Troubleshooting and Screen Guide������������������������������������������������������������������������������������������������������������������������� 17
General Troubleshooting����������������������������������������������������������������������������������������������������������������������������������������17 HARMONIC Troubleshooting�������������������������������������������������������������������������������������������������������������������������������19 ENSEAL Troubleshooting�������������������������������������������������������������������������������������������������������������������������������������23 Screen Guide����������������������������������������������������������������������������������������������������������������������������������������������������������24
Chapter 5 - Cleaning, Disinfection, Preventive Maintenance and Repair���������������������������������������������������������������������������� 33 Electrical Safety Checks�����������������������������������������������������������������������������������������������������������������������������������������33 Cleaning and Disinfection Instructions������������������������������������������������������������������������������������������������������������������33 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 Electromagnetic Compatibility (EMC)������������������������������������������������������������������������������������������������������������������38 Symbols������������������������������������������������������������������������������������������������������������������������������������������������������������������40
Generator G11
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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.
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Generator G11
Generator G11 Operator’s Manual 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.
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.
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Generator G11 Operator’s Manual 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.
Footswitch
Figure 3A 7
MIN (LEFT PEDAL)
Activates power for ENSEAL or minimum power for HARMONIC.
8
MAX (RIGHT PEDAL)
Activates maximum power for HARMONIC.
3
Generator G11
Generator G11 Operator’s Manual Cart
Figure 3B
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.
•
Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen as an explosion may occur.
•
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 or 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.
•
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.
•
Do not operate the unit in close proximity to volatile solvents such as methanol or alcohol as explosion may occur.
•
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.
•
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.
•
For patients with cardiac pacemakers or other active implants, a possible hazard exists because interference with the action of the pacemaker may occur, or the pacemaker may be damaged. In case of doubt, approved qualified advice should be obtained.
•
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.
•
No internal user serviceable parts. For service, return the generator to an authorized Ethicon Endo-Surgery service facility.
•
To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
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Generator G11 Operator’s Manual •
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.
•
This device is not MR safe and is not MR compatible.
•
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.
•
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.
•
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.
•
Removing bottom screws or opening of this device invalidates the warranty and could create hazardous condition.
•
Read instructions prior to use and follow the hospital’s clinical practice guidelines for ultrasonic surgery, electrosurgery, gynecology and laparoscopic procedures.
•
Replace fuses only with the appropriate type and rating. See System Specifications.
•
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 Generator G11, as they provide the required airflow for cooling.
•
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.
•
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.
•
Needle monitoring electrodes are not recommended.
•
Activation of a radiofrequency device, when not in contact with target tissue or in a position to deliver energy, may cause capacitive coupling.
•
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.).
•
Cables to the surgical electrodes should be positioned so that contact with patient or other leads is avoided.
•
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:
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Generator G11
Generator G11 Operator’s Manual 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 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. 1-877-ETHICON 1-513-337-8901 (English)
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Generator G11 Operator’s Manual 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. 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.
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Generator G11
Generator G11 Operator’s Manual Ready Screen Features The HARMONIC ready screen has the following features:
2
1
5
3
6
4
7
Figure 6A 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.
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.
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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. 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.
Ready Screen Features Some HARMONIC ready screens have the following features. The instrument name will be displayed after HARMONIC on the screen.
2
5
6
1
3
4
7
Figure 6B 1
SETTINGS
Touch this button to go to the system settings.
2
DEVICE SPECIFICATION
Indicates the device in use.
3
MIN
Not Available
4
MAX
Indicates the adjustable power level setting between 1 and 5. The power level may be adjusted when the generator is ready. The maximum power 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 maximum (MAX) 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 maximum (MAX) 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.
9
Generator G11
Generator G11 Operator’s Manual 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.
Operation Only the MAX power level setting is adjustable between 1 and 5 and is activated using HARMONIC device or from the footswitch. The default power level value is 5. 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. 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. 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. Note: The touch screen responses will be slower when electrosurgery is in close proximity to minimize interferences.
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.
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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. 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. Touch the desired option, a confirmation screen will appear. Select ‘OK’ to confirm the language selection or ‘Cancel’ to cancel the language change. Tone Change ON/OFF Some instruments enable additional tone changes within the generator. When this option is selected, the Tone Change ON/OFF screen will appear, allowing the user to select the Tone Change ON or Tone Change OFF options. Refer to the instrument instructions for use to determine if your 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, and the Advanced Hemostasis Mode button will be disabled. Refer to the instrument instructions for use to determine if your instrument has this feature.
Figure 8
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 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.
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Generator G11
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. 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 9 •
If the plug looks like the image below, use the connector as an interface between the device and the generator.
Figure 10 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
Generator G11 Operator’s Manual
Ready Screen Features The ENSEAL ready screen has the following features:
2
Ready
Settings
1
3
4
Figure 11 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 5.
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.
Figure 12A
Figure 12B
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 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. Touch the desired option, a confirmation screen will appear. Select ‘OK’ to confirm the language selection or ‘Cancel’ to cancel the language change.
Extended Activation Some ENSEAL instruments allow the ability for use in Extended Activation Mode. When this option is selected, the Extended Activation ON/OFF screen will appear, allowing the user to select the Extended Activation ON or Extended Activation OFF options. When this mode is enabled and the device 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 enabled. Energy delivery can be terminated at any moment by releasing the footswitch or hand activation button. If the device is unplugged or the generator is powered down while ‘Extended Activation ON’ is selected the generator will revert to the system default setting of ‘Extended Activation OFF’ .
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Generator G11
Generator G11 Operator’s Manual System Information Select ‘System Information’ to see 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. Touch the back arrow or close button to exit.
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