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Return Electrodes – REM Contact Quality Monitoring System

Monopolar Function

ForceTriad User’s Guide

4-7

REM Alarm (Visual and Audible)

If the REM system senses an alarm condition, the REM indicator flashes 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 instructions on correcting REM alarms.

When a REM alarm occurs, the large red and yellow REM icon is displayed for a
few seconds and then disappears. The small green REM icon turns red.

REM Alarm
Indicator

Содержание ForceTriad

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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