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ForceTriad User’s Guide

6-1

LigaSure Tissue Fusion

This chapter describes how to set up and operate the LigaSure

tissue fusion function of the ForceTriad energy platform.

Caution

Read all warnings, cautions, and instructions provided with this system before
use.

Read the instructions, warnings, and cautions provided with electrosurgical
instruments before use. Specific instructions for electrosurgical instruments are
not included in this manual.

C h a p t e r

Summary of Contents for ForceTriad

Page 1: ...User s Guide ForceTriad Energy Platform...

Page 2: ...ademark acknowledgements Valleylab ForceTriad Force FX Force EZ Force Argon LigaSure LigaSmart Smart Cool tip TissueFect REM RFG 3C OptiMumm SurgiStat EDGE AccuVac PolyHesive and Instant Response are...

Page 3: ...us situation which if not avoided could result in death or serious injury Caution Indicates a hazardous situation which if not avoided may result in minor or moderate injury Notice Indicates a hazard...

Page 4: ...of Valleylab Valleylab neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Valleylab s products Notwithstanding any other...

Page 5: ...lving disputes arising under or relating in any way to this warranty is the District Court of the County of Boulder State of Colorado USA Valleylab its dealers and representatives reserve the right to...

Page 6: ...vi ForceTriad User s Guide...

Page 7: ...ing Up the System 2 2 Fire Explosion Hazard 2 4 Energy Platform 2 5 Active instruments 2 6 Pacemakers and ICDs 2 6 After Surgery 2 7 Monopolar 2 7 Patient Return Electrodes 2 8 Inadvertent Radio Frequ...

Page 8: ...ctrodes 4 8 Standard Monopolar Mode Functionality 4 8 Valleylab Mode Functionality 4 9 Using a Valleylab Mode Instrument 4 10 Manual Power Control Functionality 4 11 Accessory Port Functionality 4 12...

Page 9: ...g Guidelines 7 2 REM Alarms 7 2 Correcting a REM Alarm Condition 7 2 Correcting Malfunctions 7 3 System Alarms 7 7 Chapter 8 Maintenance and Repair Responsibility of the Manufacturer 8 2 Routine Maint...

Page 10: ...ons 9 9 Symbols 9 10 Class I Equipment IEC 60601 1 9 11 Type CF Equipment IEC 60601 1 Defibrillator Proof 9 11 Liquid Spillage IEC 60601 2 2 Clause 44 3 9 11 Voltage Transients Emergency Energy Platfo...

Page 11: ...ures and functions of the ForceTriad energy platform Caution Read all warnings cautions and instructions provided with this system before use Read the instructions warnings and cautions provided with...

Page 12: ...ectrodes and active instruments are designed to work as a system Valleylab offers a selection of patient return electrodes and active instruments that are fully compatible with this energy platform Wh...

Page 13: ...The active touchscreen or touchscreens will illuminate and the unavailable touchscreens will dim Common Symbols Symbol Name Description Page Up Page Down Scroll through blocks of options that cannot...

Page 14: ...contains controls that allow you to access and adjust system settings including screen brightness and main menu options Brightness Each selection of this button adjusts the screen brightness to the ne...

Page 15: ...ient tissue Since sparks may spray unpredictably from the electrode during fulguration using fulguration for delicate tissue or in confined areas can complicate surgery Accidental sparking to adjacent...

Page 16: ...hieve a complete and permanent fusion of the vessel lumen The system has been designed to produce minimal sticking charring or thermal spread to adjacent tissue LigaSure Instruments The LigaSure instr...

Page 17: ...ructions supplied with this or any electrosurgical equipment be read understood and followed Electrosurgery has been used safely in millions of procedures Before starting any surgical procedure the su...

Page 18: ...achieves the desired surgical effect The active electrode should be utilized only for the minimum time necessary in order to lessen the possibility of unintended burn injury Accidental and unintended...

Page 19: ...orm before using Read the instructions warnings and cautions provided with electrosurgical instruments before using Specific instructions for electrosurgical instruments are not included in this manua...

Page 20: ...on connector with an equipotential cable Warning Danger Explosion Hazard Do not use electrosurgery in the presence of flammable anesthetics Fire Hazard Do not place active instruments near or in conta...

Page 21: ...may create embers that pose a fire hazard especially in oxygen enriched environments Keep the electrode clean and free of all debris Facial and other body hair is flammable Water soluble surgical lub...

Page 22: ...that is lower than the maximum output voltage may result in injury to the patient or the operator or damage to the instrument All Valleylab instruments have voltage ratings that are greater than the...

Page 23: ...probably cannot be eliminated Burns to the surgeon s hands are possible To minimize the risk take these precautions Do not buzz the hemostat with a needle electrode Do not lean on the patient the tabl...

Page 24: ...duty cycles greater than 25 10 seconds active followed by 30 seconds inactive will increase the risk that heat build up under a return electrode may be high enough to injure the patient Do not continu...

Page 25: ...be connected to the bipolar instrument receptacle only Improper connection may result in inadvertent system activation Warning LigaSure instruments are intended for use ONLY with the Valleylab ForceTr...

Page 26: ...rgical pencils or ultrasonic scalpels that are associated with thermal spread should not be used to transect seals Avoid placing fingers in the handle ratchet mechanism Injury to the user may result W...

Page 27: ...back to the energy platform you must also use a Valleylab E0507 B adapter To avoid a REM alarm you must use a REM patient return electrode with the E0507 B adapter Warning When this energy platform i...

Page 28: ...laparoscopic instrumentation with metal cannulas the potential exists for abdominal wall burns to occur due to direct electrode contact or capacitive coupling of RF current This is most likely to occu...

Page 29: ...on and configure system settings Caution Read all warnings cautions and instructions provided with this system before use Read the instructions warnings and cautions provided with electrosurgical inst...

Page 30: ...s bar disappears A tone will sound upon completion of self test 2 If the system does not pass the power up self test refer to Chapter 7 Troubleshooting System Functions Adjusting Display Brightness Th...

Page 31: ...h Setup in the main menu The setup display will appear in the left touchscreen 3 Touch Language in the setup menu A list of languages will appear in the left touchscreen 4 Touch the single up or down...

Page 32: ...he green check mark button to store the date and time information and return to the setup menu or Touch the red X button to return the time and date to the previous settings and return to the setup me...

Page 33: ...EM alarm and the dual instrument error alarm are deactivated but RF power will still be delivered Note In Demo mode the generator will not sense instrument type so the appropriate tab must be selected...

Page 34: ...3 6 ForceTriad User s Guide...

Page 35: ...e ForceTriad energy platform Caution Read all warnings cautions and instructions provided with this system before use Read the instructions warnings and cautions provided with electrosurgical instrume...

Page 36: ...e adapter REM Patient Return Electrode Receptacle Monopolar 2 Instrument Receptacle Monopolar 1 Instrument Receptacle Monopolar 1 and Accessory Touchscreen Monopolar 2 Touchscreen U S and foreign pate...

Page 37: ...cord into the rear panel receptacle 2 Plug the system power cord into a grounded power receptacle 3 Turn on the energy platform and verify that the self test is successfully completed 4 If using a foo...

Page 38: ...tion point Connect instruments to the proper receptacle Improper connection may result in inadvertent instrument activation or other potentially hazardous conditions Follow the instructions provided w...

Page 39: ...jure the patient When using a Valleylab energy platform or a patient return electrode during these types of surgical procedures the user should seek written guidance in the form of detailed user instr...

Page 40: ...reen illuminates red to indicate that the REM patient return electrode is disconnected from the energy platform or improperly applied to the patient The REM indicator icon on the touchscreen illuminat...

Page 41: ...hes red and yellow emits two beeps and discontinues RF energy delivery When the alarm condition has been corrected the indicator illuminates green Refer to the Troubleshooting chapter for detailed ins...

Page 42: ...ces will be inactivated until one of the devices is removed Standard Monopolar Mode Functionality When a two button electrosurgical instrument is attached to either the Monopolar 1 or Monopolar 2 rece...

Page 43: ...adjusts power output in all three modes When a Valleylab mode instrument s Smart connector is attached to either the Monopolar 1 or Monopolar 2 receptacle the ForceTriad energy platform detects the in...

Page 44: ...nd for the duration of the activation Activate the coag mode by pressing the blue button on the electrosurgical instrument The coag display will illuminate blue and a tone will sound for the duration...

Page 45: ...terface 1 To set the system into the manual mode press the green Manual button on the Valleylab tab touchscreen The manual control display will appear on the touchscreen 2 Adjust the power output for...

Page 46: ...l the power mode and power output level at the system interface for any footswitching instrument connected 1 Select the power output mode waveform by pressing the associated button The waveforms avail...

Page 47: ...orceTriad energy platform Caution Read all warnings cautions and instructions provided with this system before use Read the instructions warnings and cautions provided with electrosurgical instruments...

Page 48: ...5 2 ForceTriad User s Guide Front Panel Bipolar Features Rear Panel Bipolar Features Power Switch Bipolar Instrument Receptacle Bipolar Touchscreen U S and foreign patents pending 250V F8 0A 100 240 B...

Page 49: ...sication without sparking The possibility of sparking increases as desiccated tissue dries and becomes more resistant to energy flow The system protects against sparking by limiting the bipolar voltag...

Page 50: ...connected the bipolar tab displays on the center touchscreen 2 Select the power output mode waveform by pressing the associated button at the bottom of the tab The waveforms available in the bipolar...

Page 51: ...ar energy The Autobipolar mode must be enabled in the system setup menu before the autobipolar function can be used Refer to the System Setup chapter for instructions on how to enable the Autobipolar...

Page 52: ...tch button 6 Set the desired RF output delay by touching one of the six delay times available under the timer symbol 7 Set the desired impedance level at which RF energy will be discontinued by touchi...

Page 53: ...on function of the ForceTriad energy platform Caution Read all warnings cautions and instructions provided with this system before use Read the instructions warnings and cautions provided with electro...

Page 54: ...e Features Rear Panel LigaSure Features Power Switch LigaSure 2 Receptacle purple LigaSure Touchscreen LigaSure 1 Receptacle purple Purple Orange U S and foreign patents pending 250V F8 0A 100 240 Lig...

Page 55: ...ollowing sections in this chapter for detailed instructions 1 Plug the system power cord into the rear panel receptacle 2 Plug the system power cord into a grounded wall receptacle Note Do not plug in...

Page 56: ...nstrument activation the status bar in the corresponding LigaSure control panel illuminates blue and a tone sounds for the duration of energy delivery LigaSure 1 Receptacle The LigaSure 1 receptacle i...

Page 57: ...mpleted the start up self test before connecting instruments Warning Electric Shock Hazard Do not connect wet instruments to the energy platform Ensure that all instruments are correctly connected and...

Page 58: ...closed on a folded 4x4 to ensure the electrodes are properly seated in the instrument jaws Connecting LigaSure Instruments to the Energy Platform Connect the LigaSmart connector to the LigaSure 1 or L...

Page 59: ...control panel The button touched along with the buttons to the left of it become green and the standby button turns grey 2 As a safety feature you may set the ForceTriad energy platform on standby unt...

Page 60: ...2 Open the instrument jaws and inspect for a successful seal 3 Follow the suggested corrective action on the Check Instrument screen If possible reposition the instrument and regrasp tissue in another...

Page 61: ...errupted The seal cycle was interrupted before completion The handswitch or footswitch was released before the end tone activated Reactivate Energize Reactivate the seal cycle without removing or repo...

Page 62: ...rilization times to ensure steam penetration into the hinge Steam Sterilization Wrapped Steam Sterilization Unwrapped The instructions provided above have been validated by Valleylab as being capable...

Page 63: ...warnings cautions and instructions provided with this system before use Read the instructions warnings and cautions provided with electrosurgical instruments before use Specific instructions for elect...

Page 64: ...he REM symbol will return to its smaller size but will remain red and RF energy will remain disabled until the REM alarm is corrected When you correct a REM alarm condition the system is enabled and t...

Page 65: ...stance Energy platform does not respond when turned on Disconnected power cord or faulty wall outlet Check power cord connections energy platform and wall outlet Connect the power cord to a functional...

Page 66: ...al component malfunction Contact your biomedical engineering department or a Valleylab technical service representative for assistance System does not detect tissue fusion instrument Firmly insert the...

Page 67: ...ed fluids around instrument tip Minimize or remove excess fluids REACTIVATE screen appears a four pulsed tone sounds and RF output is disabled The seal cycle was interrupted before completion The hand...

Page 68: ...trode Pacemaker interference Intermittent connections or metal to metal sparking Check the active and patient return electrode cord connections It may be necessary to reprogram the pacemaker Current t...

Page 69: ...ine how to correct an alarm condition After correcting the alarm condition verify that the system completes the self test as described in the System Setup chapter Description or Screen Solution Check...

Page 70: ...Situations in Chapter 6 Dual Instrument Alert Disconnect one instrument connected under associated screen Invalid Instrument Alert Disconnect invalid instrument Use appropriate instrument Refer to in...

Page 71: ...ntenance Returning the energy platform for service Service centers Caution Read all warnings cautions and instructions provided with this system before use Read the instructions warnings and cautions...

Page 72: ...ergy platform be checked or serviced Valleylab recommends that the energy platform be inspected by qualified service personnel at least twice a year This inspection should include adjusting the system...

Page 73: ...latform call your Valleylab sales representative for assistance If you are instructed to send the energy platform to Valleylab do the following 1 Obtain a return authorization number Call the Valleyla...

Page 74: ...c Ship the energy platform prepaid to the Valleylab Service Center Adjustment to Factory Specification Calibration Valleylab recommends that only Valleylab authorized personnel calibrate the ForceTria...

Page 75: ...hin 20 of a stated value at room temperature 25 C 77 F and a nominal line input voltage Caution Read all warnings cautions and instructions provided with this system before use Read the instructions w...

Page 76: ...ection and fan Display Three LCD touchscreens Connector ports LED illuminated Smart connector readers Mounting ForceTriad energy platform cart FT900 Universal Mounting cart UC8009 and or the UC8010 Ov...

Page 77: ...eratures outside the operating temperature range allow one hour for the energy platform to reach room temperature before use Ambient temperature range 30 C to 65 C Relative humidity 0 to 90 non conden...

Page 78: ...while the system is activated Volume not adjustable 65 dBA Frequency REM 660 Hz Regrasp Two tones High 985 Hz Low 780 Hz Seal Complete 985 Hz Error System Alert Beep tone 1400 Hz Duration REM Two 1 2...

Page 79: ...ial measured contact resistance increases by 40 whichever is less the REM alarm indicator enlarges and flashes red and yellow a tone sounds twice and RF output is disabled The indicator remains illumi...

Page 80: ...ation impedance while keying active at 10 watts or below 5 of Full Scale activation impedance while keying inactive Keying delay User selectable in 500 msec increments from 0 sec to 2 5 sec Caution Us...

Page 81: ...ne voltage Idle 52 VA Bipolar 450 VA Cut 924 VA Coag 530 VA Input mains voltage full regulation range 90 132 Vac Input mains voltage full regulation range 208 264 Vac Input mains voltage operating ran...

Page 82: ...een 48 Hz and 62 Hz The User does not need to reconfigure the ForceTriad energy platform for different line frequencies Input Current The ForceTriad energy platform draws no more than 10A at any line...

Page 83: ...n ATTENTION Consult accompanying documents The generator output is floating isolated with respect to ground DANGER Explosion risk if used with flammable anesthetics To reduce the risk of electric shoc...

Page 84: ...ar instrument receptacle LigaSure related receptacle or footswitch Color coded LigaSure footswitch symbol for matching rear panel connector to front panel receptacle REM patient return electrode recep...

Page 85: ...ures involving the heart This generator complies with the ANSI AAMI HF18 specifications for defibrillator proof designation and IEC 60601 2 2 Liquid Spillage IEC 60601 2 2 Clause 44 3 The ForceTriad e...

Page 86: ...0601 1 2 sub clause 36 201 1 IEC 60601 2 2 sub clause 36 and CISPR 11 Class A Harmonic distortion IEC 60601 1 2 sub clause 36 201 3 1 and IEC 61000 3 2 Conducted disturbances IEC 60601 1 2 sub clause...

Page 87: ...out a cutting effect Mode Open Circuit Peak Voltage max Open Circuit P P Voltage max Rated Load max Power max Crest Factor Duty Cycle Bipolar Low Standard Macro 250 V 175 V 250 V 500 V 350 V 500 V 100...

Page 88: ...39 40 45 50 55 60 65 70 75 80 85 90 95 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 45 50 55 60 65 70 75 80 85 90 95 100 110 120 130 1...

Page 89: ...11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 45 50 55 60 65 70 75 80 85 90 95 100 110 120 130 140 150 160 170 180 190 200 1 2 3 4 5 6 7 8 9 10 11 12 13 14...

Page 90: ...and to minimize sparking Bipolar Monopolar Cut Valleylab Monopolar Coag Low 472 kHz sinusoid continuous Standard 472 kHz sinusoid continuous Macro 472 kHz sinusoid continuous Cut 472 kHz sinusoid con...

Page 91: ...r setting for Pure cut power Peak voltage versus power setting for Pure cut power 0 50 100 150 200 250 300 350 0 1000 2000 3000 4000 5000 50 100 Load Impedance ohms Output power watts 0 50 100 150 200...

Page 92: ...us power setting for Blend power 0 50 100 150 200 250 0 1000 2000 3000 4000 5000 50 100 Load Impedance ohms Output power watts 0 20 40 60 80 100 120 140 160 180 200 0 50 100 150 200 Blend Output Power...

Page 93: ...k voltage versus power setting for Fulgurate power 0 20 40 60 80 100 120 140 0 1000 2000 3000 4000 5000 50 100 Load Impedance ohms Output power watts 0 20 40 60 80 100 120 0 20 40 60 80 100 120 Fulgur...

Page 94: ...etting for Spray power 0 20 40 60 80 100 120 140 0 500 1000 1500 2000 2500 3000 3500 4000 50 100 Output power watts Load Impedance ohms 0 20 40 60 80 100 120 140 0 20 40 60 80 100 120 Spray Output Pow...

Page 95: ...tage versus power setting for Valleylab power 0 50 100 150 200 250 0 1000 2000 3000 4000 50 100 Load Impedance ohms Output power watts 0 20 40 60 80 100 120 140 160 180 200 0 50 100 150 200 Hemostasis...

Page 96: ...ower Peak voltage versus power setting for Bipolar Low power 0 10 20 30 40 50 60 70 80 90 100 0 500 1000 1500 2000 50 100 Load Impedance ohms Output power watts 0 10 20 30 40 50 60 70 80 90 0 20 40 60...

Page 97: ...ng for Bipolar Standard power Note Maximum peak voltage in the Bipolar Standard mode occurs at 500 not open circuit 0 10 20 30 40 50 60 70 80 90 100 0 500 1000 1500 2000 50 100 Output power watts Load...

Page 98: ...ak voltage versus power setting for Bipolar Macro power 0 10 20 30 40 50 60 70 80 90 100 0 500 1000 1500 2000 50 100 Load Impedance ohms Output power watts 0 10 20 30 40 50 60 70 80 90 0 20 40 60 80 B...

Page 99: ...sus impedance for LigaSure power Peak voltage versus impedance for LigaSure power 0 20 40 60 80 100 120 140 160 180 200 0 100 200 300 400 500 600 3 5A 5 5A 1 0A Load Impedance ohms Output power watts...

Page 100: ...9 26 ForceTriad User s Guide...

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