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ForceTriad™

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1. 6 4 Liga Sure Ee ee r a a ara 6 4 LigaSure 2 Receptacle ioni inane 6 4 viii ForceTriad User s Guide me MU HI 6 5 LAM SY CW E oes coe sat RM NEC R RE ERES DEMEURE EARN 6 5 6 6 Reusable Instrument amp 6 6 Connecting LigaSure Instruments to the Energy Platform esses 6 6 LigaStre 6 7 Changing the Energy Delivery Setting 6 7 Activating the LigaSure Instrument 6 7 PALS MTs SIT AU ONS e cente D NI Md m PNE IIT DE TM UE 6 8 After SUNG UY 6 9 Disconnect the instruments 6 9 Reprocessing Instrumernts cron Yn YW FYND RD nnmero mannm uem EUW Sn YS NR 6 10 Chapter 7 Troubleshooting General Troubleshooting Guidelines 7 2 REM SAN eud 7 2 Correcting a REM Alarm 7 2 Correcting Malf nctiOns s eric ILL ana taedet entente
2. 0 20 40 60 80 Power Setting 9 22 ForceTriad User s Guide Output Power vs Resistance Graphs Output power versus impedance for Bipolar Standard power Output power versus power setting for Bipolar Standard power Peak voltage versus power setting for Bipolar Standard power Bipolar Standard 100 90 80 70 60 50 50 100 40 T7 30 4 20 Output power watts 4 500 1000 1500 2000 Load Impedance ohms Bip Std Output Power vs Setting 100ohm Output power watts 0 20 40 60 Power Setting 350 300 250 500ohm Bipolar 200 150 Standard Peak Voltage vs Power Peak Voltage Setting 100 0 20 40 60 Power Setting 80 Note Maximum peak voltage in the Bipolar Standard mode occurs at 500 O not open circuit ForceTriad User s Guide 9 23 suomneouioeds eoiuuo9 Output Power vs Resistance Graphs Bipolar Macro Output power versus impedance for Bipolar Macro power 100 90 80 70 60 50 50 40 100 Output power watts Output power versus power setting for Bipolar Macro power 90 500 1000 1500 Load Impedance ohms 2000 80
3. 9 6 Low Frequency 50 60 Hz Leakage 9 6 High Frequency RF Leakage Current 9 7 riDUt POWE FFO Ou 9 7 Power Cord Specification 9 8 I 9 8 Curent 9 8 POW TE 9 8 Eguipotential Ground Connection eese esseseeese tete en nne tntn 9 8 ECG BlanKitlg e e Sd di do 9 8 Standards and 5 9 9 9 9 een 9 10 Glass Equipment 60601 1 t cete i EE iei 9 11 Type CF Equipment 60601 1 Defibrillator 9 11 Liquid Spillage 60601 2 2 Clause 44 3 9 11 Voltage Transients Emergency Energy Platform Mains Transfer eee 9 11 Electromagnetic Compatibility 60601 1 2 and 60601 2 2 esses 9 12 Output Characteristics ic 9 13 Maximum Output for Bipolar Monopolar and LigaSure Modes sss 9 13 Available Power Settings in 9 14 Se AVEC 9 16 Output Power vs Resistance Graphs 9 17
4. Ern 9 17 Bipolar Graphs 9 22 X ForceTriad User s Guide ForceTriad Energy Platform Overview and General Features This chapter provides an overview of the features and functions of the ForceTriad energy platform 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 ForceTriad User s Guide 1 1 ForceTriad Energy Platform Front Panel ForceTriad Energy Platform Front Panel Monopolar 1 Accessory Touchscreen Monopolar 2 and Bipolar Touchscreen LigaSure and System Tray Touchscreen N x PFORCE TIRUND 1 iA 2 Monopolar 2 LigaSure 1 2 Bipolar LigaSure 2 LJ P LigaSure 1 Sach Universal Footswitching Monopolar 2 Instrument Re eptacle Accessory Receptacle REM Patient Return Receptacle Electrode Receptacle Bipolar instrument Receptacle LigaSure 2 Receptacle Monopolar 1 Instrument Receptacle Introduction The ForceTriad energy platform is designed to provide RF energy for monopolar and bipolar surgical applications and tissue fusion application
5. A019uy peu 99104 System Conventions Symbol Name Description Bipolar Mute On Off Turn on off the audio tones produced by the system that indicate the increase or decrease of current during a bipolar procedure Cancel Cancels current screen and returns to the previous screen Enter Accepts and initiates current selections System Tray The system tray 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 next of the two available brightness settings When maximum brightness is reached next selection resets to the least bright setting Wrench Select access to the main menu which provides user selected options for language appearance and operation Errors This indicates that error warnings have been disabled using the Disabled service menu The generator will not alarm or give error conditions when this symbol is activated Note Additional information on symbols may be found in the Technical Specifications chapter in this manual 1 4 ForceTriad User s Guide Power Modes Power Modes As a safety feature to prevent unexpected power delivery spikes simultaneous activation of multiple instruments is not possible on the ForceTriad energy platform Monopolar Modes The ForceTriad energy platform produces five different mod
6. Mareyiab Bipolar A Standard Macro ForceTriad User s Guide Kie0uns 1ejodig Autobipolar Electrode Function 10 Select the power output mode waveform by touching the associated button at the bottom of the tab The waveforms available in the Autobipolar mode are Low Standard and Macro Setthe power to the desired output level by touching the green up and down arrows Power output is displayed in watts To change the autobipolar activation parameters touch the green Setup button Setup The setup display will appear in the autobipolar tab Toenable RF activation without needing to depress the footswitch touch the Auto button Auto or To restrict RF activation to the footswitch touch the footswitch handswitch button S R Set the desired RF output delay by touching one of the six delay times available under the timer symbol Set the desired impedance level at which RF energy will be discontinued by touching one of the four impedance values under the impedance symbol Touch the green back arrow button to return to the autobipolar activation display The settings selected in the setup display will appear in the autobipolar display Activate autobipolar by closing the instrument forceps tines firmly or by stepping on the single pedal footswitch An activation tone will sound To return the energy platform to bip
7. V amp Fuse CAUTION b 4 Port Warning Risk of Fire eplace Fuse as Marke 250V F8 0A 100 240 USB T E 9 e Port 2 E Ethernet Port LigaSure 2 Bipolar BR X T RS232 Port Interlink Cable Port Monopolar Footswitch Receptacle requires adapter to connectstandard four pin monopolar footswitch U S and foreign patents pending Expansion Port 4 2 ForceTriad User s Guide Monopolar Quick Setup Instructions Monopolar Quick Setup Instructions If you are familiar with the ForceTriad energy platform you may follow this abbreviated procedure to set up the system for monopolar surgery If you are not familiar with the ForceTriad energy platform refer to the following 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 power receptacle 3 Turn on the energy platform and verify that the self test is successfully completed 4 If using a footswitch connect it to the monopolar footswitch receptacle on the rear panel This may require an adapter to connect a standard four pin monopolar footswitch 5 Apply the pa
8. for Fulgurate power 120 4 100 1 80 Fulgurate Output 60 Power vs Setting 500 8 40 20 0 Y 0 20 40 60 80 100 120 Power Setting Peak voltage versus power setting for Fulgurate power Open Circuit Fulgurate Peak Voltage vs Power Setting Peak Voltage 0 20 40 60 80 100 120 Power Setting ForceTriad User s Guide 9 19 eoiuuo9 Output Power vs Resistance Graphs Spray Output power versus impedance for Spray power Output power watts Output power versus power setting for Spray power Output power watts Peak voltage versus power setting for Spray power Peak Voltage 140 120 100 80 60 40 4 20 50 100 0 500 1000 1500 2000 2500 3000 3500 4000 Load Impedance ohms 140 120 100 80 60 40 20 Spray Output Power vs Setting 500ohm o 20 40 60 80 100 120 P ower Setting Open Circuit Spray Peak Voltage vs Power Setting 40 60 80 100 120 P ower Setting 9 20 ForceTriad User s Guide Output Power vs Resistance Graphs Valleylab Output power versus impedance for Valleylab power 250 200 150 50 100 100 Output po
9. 70 60 Bip Macro Output 50 Power vs 40 30 100ohm 20 10 Output power watts Peak voltage versus power setting for Bipolar Macro power 20 40 60 80 Power Setting 250 200 150 100 Peak Voltage 50 20 40 60 80 Power Setting Open Circuit Bipolar Macro Peak Voltage vs Power Setting 9 24 ForceTriad User s Guide Output Power vs Resistance Graphs Output power versus impedance for LigaSure power Peak voltage versus impedance for LigaSure power LigaSure Output power watts Peak Voltage 200 180 160 140 120 100 250 200 150 100 50 m 3 5A amp 5 5A e 1 0A 100 200 300 400 500 600 Load Impedance ohms 3 5A Vpeak m 5 5A Vpeak amp 1 0 100 200 300 400 500 600 Load Impedance ohms ForceTriad User s Guide 9 25 suomneouioeds eoiuuo9 Kalleylab 9 26 ForceTriad User s Guide
10. Pooled fluids around the instrument tip minimize or remove excess fluids 6 8 ForceTriad User s Guide After Surgery After Surgery Reactivate A four pulsed tone will sound when the Reactivate screen is displayed If this message appears the user should 1 Release the footswitch pedal or hand switching button 2 Reactivate the seal cycle without repositioning the instrument ANB eactivate Endpoint not reached Seal cycle interrupted Reactivate Endpoint not reached Additional time and energy needed to complete fusion cycle Seal cycle interrupted 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 repositioning the instrument Disconnect the instruments 1 Turn off the energy platform 2 Disconnect all instruments from the front panel If the instrument is single use only disposable dispose of it according to the procedures for your institution If the instrument is reusable clean and sterilize it according to the manufacturer s instructions for use 3 Disconnect and store any footswitch es used ForceTriad User s Guide uoisn 4 enssi After Surgery Reprocessing Instruments Clean the Reusable LigaSure Instrument 1 Remove and dispose of single use electrodes 2 Wipe all surface
11. Ealleylab User s Guide ForceTriad Energy Platform This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed It is intended as a guide for using the Valleylab ForceTriad energy platform only Additional technical information is available in the ForceTriad TM Energy Platform Service Manual Federal USA law restricts this device to sale by or on the order of a physician Eguipment covered in this manual ForceTriad energy platform Valleylab Part Number 1004175 Effective Date September 2006 Trademark acknowledgements Valleylab ForceTriad Force Force EZ Force Argon LigaSure LigaSmart Smart M Cool tip TissueFect RFG 3C OptiMumm SurgiStat EDGE AccuVac PolyHesive and Instant Response are trademarks of Valleylab Klenzyme is a trademark of the STERIS Corporation Enzol is a trademark of Johnson and Johnson Medical Inc Patents pending Manufactured by Valleylab a division of Tyco Healthcare Group LP Boulder Colorado 80301 3299 USA For information call 1 303 530 2300 European representative Tyco Healthcare UK Ltd Gosport PO13 OAS UK Made in USA Printed in USA 2006 Valleylab All rights reserved ForceTriad User s Guide Conventions Used in this Guide Indicates a potentially hazardous situa
12. Power Switch Bipolar Touchscreen Bipolar Instrument Receptacle Rear Panel Bipolar Features e A GAS Warning Risk of Fire 5 f AY Replace Fuse as Marked 2 250V F8 0A 100 240 NI EE ow l Wa U S and foreign patents pending Bipolar Footswitch Receptacle 5 2 ForceTriad User s Guide Bipolar Quick Setup Instructions Bipolar Quick Setup Instructions If you are familiar with the ForceTriad energy platform you may follow this abbreviated procedure to set up the system for bipolar surgery If you are not familiar with the ForceTriad energy platform refer to the following 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 into a power strip or extension cord 3 Turn on the system and verify that the self test is successfully completed 4 If using a footswitch connect it to the bipolar footswitch receptacle on the rear panel 5 Connect the instrument to the bipolar instrument receptacle on the front panel 6 Verify or change the mode and power settings Bipolar Function Overview Delicate tissue requires less energy to desiccate The ForceTriad energy platform provides low voltage continuous current for faster dessication without sparking
13. Software Upgrades Service Centers Valleylab recommends that only Valleylab authorized personnel calibrate the ForceTriad energy platform The energy platform incorporates automatic calibration where possible to reduce the required equipment and manual steps Software upgrades must be performed by authorized personnel only For a complete list of service centers worldwide please refer to the Valleylab website http www valleylab com valleylab international service world html ForceTriad User s Guide Technical Specifications All specifications are nominal and subject to change without notice A specification referred to as Typical is within 20 of a stated value at room temperature 25 C 77 F and a nominal line input voltage 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 ForceTriad User s Guide 9 1 Performance Characteristics Performance Characteristics General Output configuration Isolated output Cooling Natural convection 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 Overshelf Operating room boom systems An
14. 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 voltage at relatively high levels of tissue resistance Bipolar Power Output Modes The ForceTriad energy platform produces three bipolar modes Low Standard and Macro Electric Shock Hazard Do not connect wet instruments to the energy platform Ensure that all instruments and adapters are correctly connected and that no metal is exposed at any connection point Connect instruments to the proper receptacle Improper connection may result in inadvertent instrument activation or other potentially hazardous conditions Follow the instructions provided with electrosurgical instruments for proper connection and use The instrument receptacles on this system are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Read the instructions warnings and cautions provided with electrosurgical instruments before use Specific instructions are not included in this manual ForceTriad User s Guide 5 3 Kie0uns 1ejodig Footswitch Footswitch Inspect instruments and cords especially reusable instruments and cords for breaks cracks nicks and other damage before every use If damaged do not use Failure to observe th
15. Slider Position Indicator a REM Indicator __ Manual Selector Button Power Zones The five gold bars in the center of the Valleylab tab represent the five power zones available for the particular instrument attached to the energy platform receptacle The system automatically selects the default power zone setting for the particular instrument Power zones can only be changed at the touchscreen interface on the energy platform Note Refer to the individual instrument instructions for power zone output in watts Slider Position The energy platform detects the current position of the instrument s slider switch and the slider position indicator on the right side of the Valleylab tab displays this slider position Slider position can only be changed by the instrument user in the sterile field ForceTriad User s Guide uonoung4 Jejodouo N Active Electrodes Using a Valleylab Mode Instrument 1 Select the desired power zone by touching the corresponding bar on the Valleylab tab touchscreen The bar that was touched along with all the bars below it will illuminate gold and a brief double tone will sound Power output is displayed in watts The power zone cannot be changed during instrument activation The slider switch increases and decreases power output Verify slider position prior to activation 2 Activate power output by pressing the desired button on the instrument Activate the cut mode by
16. The ForceTriad energy platform is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which when wetted are likely to adversely affect the safety of the equipment Voltage Transients Emergency Energy Platform Mains Transfer The ForceTriad energy platform continues to operate normally with no errors or system failures when transfer is made between line AC and an emergency energy platform voltage source IEC 60601 2 2 sub clause 51 101 and AAMI HF18 sub clause 4 2 2 ForceTriad User s Guide suomneouioeds eoiuuo9 Symbols Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 The ForceTriad energy platform complies with the appropriate IEC 60601 1 2 and 60601 2 2 specifications regarding electromagnetic compatibility Notice The ForceTriad energy platform requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ForceTriad energy platform service manual Portable and mobile RF communications equipment can affect the ForceTriad energy platform Refer to the EMC information provided in the ForceTriad energy platform service manual The ForceTriad energy platform meets the following requirements ESD Immunity IEC 60601 1 2 Sub Clause 36 202 and IEC 61000 4 2 Radiated Immunity IEC 60601 1 2 sub clause 36 202 2 and IEC 61000 4 3 Electrical Fast Transient Burst IEC 60601 1 2 su
17. status bar will display the words Invalid Instrument Refer to the following steps to resolve the issue 1 Confirm you are using a LigaSure instrument 2 Reconnect the instrument using firm pressure to insert the instrument into the LigaSure 1 or LigaSure 2 instrument receptacle 3 If you still see the words Invalid Instrument in the status bar use a new LigaSure instrument or electrode 6 6 ForceTriad User s Guide LigaSure Settings LigaSure Settings Changing the Energy Delivery Setting Confirm proper power or intensity settings before proceeding with surgery The green bars on the LigaSure vessel fusion display panel represent different levels of desiccation Two green bars are the default setting for all LigaSure tissue fusion instruments This setting allows the energy to precisely affect the target tissue resulting in permanent tissue fusion with minimal thermal spread to the surrounding tissues Occasionally the surgeon may encounter tissue or vessels that are fused more effectively with a one or three bar fusion cycle By selecting one bar the surgeon can expect a more gentle and typically longer fusion cycle which can be potentially more effective in thinner tissue bundles and smaller isolated vessels By selecting three bars the surgeon can expect a longer fusion cycle which can be potentially more effective in thicker tissue bundles Notice The one and three bar seal cycles may result in tissue sti
18. Autobipolar button to disable the Autobipolar mode Touch the green arrow button below the setup menu to return to the main menu ForceTriad User s Guide System Functions Demo Mode Demo mode is intended for demonstration purposes only Demo mode is not intended for clinical use Touch the wrench icon on the right side of the right touchscreen The main menu display will appear in the left touchscreen Enable Demo Mode 1 In the main menu the Demo mode button will display Enter Demo if the system is not in Demo mode Touch the Enter Demo mode button to begin Demo mode The system operating displays will appear in all the touchscreens with the words DEMO MODE Not for Clinical Use on all three screens Note Touching the Demo mode screen will remove it briefly from all touchscreens 2 Proceed with any practice or demonstration scenarios While in Demo mode the REM 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 manually for the connected instrument 3 To exit Demo mode either turn the system off and restart it or follow the steps in the Exit Demo Mode section as follows Exit Demo Mode 1 Touch the wrench icon on the right side of the right touchscreen The main menu display will appear in the left touchscreen 2 In the main menu the Demo mode
19. ForceTriad logo will appear on all three screens e A status bar indicates activity e An hourglass icon indicates activity after the status bar disappears A tone will sound upon completion of self test If the system does not pass the power up self test refer to Chapter 7 Troubleshooting Adjusting Display Brightness The ForceTriad energy platform screens have two levels of brightness Touch the brightness icon on the right side of the right touchscreen to adjust the display brightness Activation Log The Activation Log allows the user to view the last 1000 activations and REM alerts 1 Touch the wrench icon on the right side of the right touchscreen The main menu display will appear in the left touchscreen 2 Touch Activation Log in the main menu The activation log will appear on the center touchscreen 3 Touch the single up or down arrows to the right of the activation log to scroll through the log one line at a time 4 Touch the green arrow button on the bottom right corner of the main menu screen to return the ForceTriad energy platform to the previous setup configuration The last settings will be displayed ForceTriad User s Guide System Functions Service Display Refer to the ForceTriad energy platform service manual for complete service instructions Restore Select the Restore button in the main menu to restore the ForceTriad energy platform to the previous setup configuration The touchsc
20. activation or movement of the activated LigaSure instrument outside of the field of vision may result in injury to the patient Do not activate the instrument while the instrument jaws are in contact with or in close proximity to other instruments including metal cannulas as localized burns to the patient or physician may occur Do not activate the LigaSure function in an open circuit condition Activate the energy platform only when the instrument is near or in direct contact with the target tissue to reduce the possibility of unintended burns Carefully insert and withdraw LigaSure instruments from cannulas to avoid possible damage to the devices and or injury to the patient 2 10 ForceTriad User s Guide Servicing Servicing Shunt Cords Electric Shock Hazard Do not remove the energy platform cover Contact authorized personnel for service Notice Refer to this system s service manual for maintenance recommendations and function and output power verification procedures Some surgical instruments e g colonoscopes may allow substantial leakage current that could burn the surgeon If the instrument manufacturer recommends the use of a shunt cord s cord to direct the current 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 Procedures Where Conductive Fluid is Introduced into the Surgical Sit
21. and followed Electrosurgery has been used safely in millions of procedures Before starting any surgical procedure the surgeon should be trained in the particular technique and surgical procedure to be performed should be familiar with the medical literature related to the procedure and potential complications and should be familiar with the risks versus the benefits of utilizing electrosurgery in the procedure ForceTriad User s Guide 2 1 General General Setting Up the System Warning Electric Shock Hazard Connect the system power cord to a properly grounded power receptacle Do not use power plug adapters Fire Hazard Do not use extension cords Patient Safety Use the energy platform only if the power up self test has been completed as described in this manual otherwise inaccurate power outputs may result When using a smoke evacuator in conjunction with the ForceTriad energy platform set the system volume control at a level that ensures that the activation tones can be heard Connect only Valleylab approved footswitches Using footswitches from other manufacturers may cause equipment malfunction Warning Hazardous Electrical Output This equipment is for use only by trained licensed physicians Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use of this equipment without such training can result in serious unintended patient injury in
22. associated button The waveforms available in the cut mode are Pure and Blend In the coag mode the waveforms available are Fulgurate or Spray 2 Setthe power to the desired output level by pressing the green up and down arrows Power output is displayed in watts 3 Activate the cut mode by stepping on the cut or yellow pedal on the footswitch The cut display will illuminate yellow and a tone will sound for the duration of the activation Activate the coag mode by stepping on the coag or blue pedal on the footswitch The coag display will illuminate blue and a tone will sound for the duration of the activation ForceTriad User s Guide Bipolar Surgery This chapter describes the bipolar surgery features of the ForceTriad energy platform 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 ForceTriad User s Guide 5 1 Front Panel Bipolar Features Front Panel Bipolar Features 4 2 4 _ JA J Os Monopolar 2 TT 32
23. button will display Exit Demo if the system is in Demo mode Touch the Exit Demo button in the main menu to exit the Demo mode The system touchscreens will display the last settings entered during the Demo mode ForceTriad User s Guide 3 5 dnjes Kalleylab 3 6 ForceTriad User s Guide Monopolar Function This chapter describes the monopolar surgery features of the ForceTriad energy platform 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 ForceTriad User s Guide 4 1 Front Panel Monopolar Features Front Panel Monopolar Features Monopolar 1 and Accessory Touchscreen Monopolar 2 Touchscreen Monopolar 1 2 2 LigaSure 1 19 e JE es TC ure ae E LI gt 2 LigaSure 2 Power Monopolar 1 Universal Footswitching Accessory REM Patient Return Monopolar 2 Switch Instrument Receptacle Receptacle may require 0502 1 Electrode Receptacle Instrument Receptacle E0017 active adapter Rear Panel Monopolar Features a UN ion
24. pressing the yellow button on the electrosurgical instrument The cut display will illuminate yellow and a tone will sound for the duration of the activation e Activate the Valleylab mode by pressing the clear button on the electrosurgical instrument The Valleylab display will illuminate white and a tone will sound for the duration of the activation e 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 of the activation 3 Change power output within the selected zone by adjusting the slider position on the electrosurgical instrument A double tone will sound when slider position is changed Slider position can not be changed while RF energy is being delivered Cut Mode Disable As a safety feature power output can be disabled in the cut mode 1 Disable the cut mode by pressing the yellow cut output mode display box A will replace the numeric digits in the cut box 2 Re enable the cut mode by pressing the yellow cut output mode display box The cut box will display the power setting of the current instrument slider position The cut mode is also re enabled when the energy platform is restarted ForceTriad User s Guide Active Electrodes Manual Power Control Functionality The manual mode allows the user to operate the energy platform outside the pre set power ranges available in the Valleylab tab In man
25. requires proper placement of the patient return electrode To avoid electrosurgical burns beneath the patient return electrode follow all directions provided with the product Do not cut a patient return electrode to reduce its size Patient burns due to high current density may result A patient return electrode is not necessary in bipolar or LigaSure procedures To avoid patient burns ensure that the patient return electrode firmly and completely contacts the skin Always check the patient return electrode periodically and after the patient is repositioned and during procedures involving long periods of activation Use of duty cycles greater than 2596 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 continuously activate for longer than one minute Notice Capacitive pads and other patient return electrodes may not work with the ForceTriad energy platform Important A statement of compatibility from the patient return electrode manufacturer should be obtained prior to the use of a non Valleylab CQM patient return electrode Inadvertent Radio Frequency RF Burns Electrodes and probes used with monitoring stimulation and imaging devices or similar equipment can provide a path for high frequency current even if the electrodes or probes are isolated at 50 60 Hz insulated and or batt
26. surgical effects Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when the energy platform is delivering RF energy A non functioning ForceTriad energy platform may cause interruption of surgery A backup system should be available for use Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means Inadvertent activation may occur while installing removing or bending electrodes Ensure that the instrument cord is not connected to the ForceTriad energy platform or that the system is OFF a U S Department of Health and Human Services National Institute for Occupational Safety and Health NIOSH Control of Smoke from La ser Electric Surgical Procedures HAZARD CONTROLS Publication No 96 128 September 1996 ForceTriad User s Guide 2 3 Kayes pue juaijed General Notice Connect the power cord to a properly grounded power receptacle having the correct voltage Otherwise product damage may result Important If required by local codes connect the energy platform to the hospital equalization connector with an equipotential cable Fire Explosion Hazard Danger Explosion Hazard Do not use electrosurgery in the presence of flammable anest
27. to the patient or surgical team The ForceTriad energy platform in LigaSure mode can accommodate two single pedal LigaSure footswitches If you plan to activate the LigaSure instrument connected to the LigaSure 1 instrument receptacle with a footswitch attach the purple seven pin LigaSure footswitch connector plug to the purple LigaSure 1 footswitch receptacle on the rear panel If you plan to activate the LigaSure instrument connected to the LigaSure 2 instrument receptacle with a footswitch attach the orange nine pin LigaSure footswitch connector plug to the orange LigaSure 2 footswitch receptacle on the rear panel 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 into a power strip or extension cord 3 Turn the system power switch to the ON position Note Verify that the system has successfully completed the start up self test before connecting instruments ForceTriad User s Guide 6 5 uoisn 4 enssi LigaSure Instruments LigaSure Instruments Reusable Instrument Assembly LigaSure instruments that require single use electrodes must be used with the correct electrode type Use of these instruments with any other electrodes could result in injury to the patient or surgical team or cause damage to the instrument To prepare the reusable LigaSure instruments to be used for the procedure refer to th
28. to automatically start or stop bipolar RF energy delivery Optionally the user may choose between footswitch start and auto start or program a delay between auto start and RF activation ForceTriad User s Guide 1 5 pue MeiAJeAO A019uy peu 2004 Power Modes LigaSure Mode The LigaSure tissue fusion mode can be used on arteries veins and lymphatics up to and including 7 mm in diameter and tissue bundles This system provides precise energy delivery and electrode pressure to vessels for a controlled time period to achieve 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 instruments that complete the ForceTriad tissue fusion system include multiple reusable and single use instruments for open and laparoscopic procedures Each reusable instrument requires a corresponding single use electrode The LigaSure function is only available when using Valleylab LigaSure instruments ForceTriad User s Guide Patient and Operating Room Safety The safe and effective use of electrosurgery depends to a large degree upon factors solely under the control of the operator There is no substitute for a properly trained and vigilant surgical team It is important that the operating instructions supplied with this or any electrosurgical equipment be read understood
29. 2 Setting WP THE SyStelri aca 2 2 Fro Explosion Hazard ado SG SO Fd dl 2 4 Energy Platform 2 5 Active a erue C 2 6 Pacemakers and ODS 2 6 After SUrg ry 2 7 ignes EET e R A FACH HR FF IFE IH E E T ET 2 7 Patient Return 5 2 8 Inadvertent Radio Frequency RF 5 2 8 BION aig aah Ru UMEN ERE 2 9 2 9 LigaSure in Laparoscopic Procedures ssesssssseceseeeneesssesesseeseeseeseeaeseeeessaeseeeeesaeaeeeeeneaseeeeesaeanseeseneats 2 10 i um 2 11 Users mu RE 2 11 Procedures Where Conductive Fluid is Introduced into the Surgical Site sss 2 11 Laparoscopic t 2 12 Chapter 3 System Setup Y Y Y FY I ona FY I YR H E 3 2 RR FWD 3 2 Powering Up the ForceTriad Energy Platform 3 2 System E pete nde n uda ates M d TEE DE 3 2 Adjusting Display Brightness 3 2 veneto RN 3 2 ForceTriad Us
30. 7 8 AF 7 7 Chapter 8 Maintenance and Repair Responsibility of the Manufacturer 8 2 Routine Maintenance 8 2 GIS ANI T 8 3 Product SENCE 8 3 Returning the Energy Platform for 8 3 Adjustment to Factory Specification Calibration cesses eeeieeeee eese 8 4 Software Upgrade m 8 4 Service Centers M 8 4 Chapter 9 Technical Specifications Performance Characteristics 9 2 G 9 2 Wig p 9 2 Operating Parameters 9 3 elo zT ERE EE m 9 3 Internal X X A 9 3 Activation a aM DE 9 4 9 4 REM Gontact Quality an nennt attin tnis 9 5 ForceTriad User s Guide 9 5
31. Autobipolar Electrode Function Virtual Ammeter The virtual ammeter on the bipolar tab displays the current being delivered during bipolar instrument activation The ammeter registers current between 1 and 1050 milliamps An audio tone sounds to indicate increases and decreases in current delivery A mute button allows the user to silence the ammeter tone but not the activation tone Autobipolar Electrode Function The ForceTriad energy platform is equipped with an autobipolar feature that allows the user to configure the system for automatic activation and cessation of bipolar 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 mode When the Autobipolar mode has been enabled a green button with an A will appear on Bipolar tab Note The autobipolar electrode function requires the use of the Valleylab E0018 bipolar instrument cord Use of other Valleylab bipolar cords or cords produced by other manufacturers may not result in electrical output for which these instruments were designed and thus may not result in the desired clinical effect Power Output Modes Watts Autobipolar Mode Button Power Output Mode Waveforms 1 Press the Autobipolar mode button The tab title will change from Bipolar to Auto and the screen below will appear Std Mono
32. alarms require some action on your part to correct the condition however some are corrected automatically Use the following list to determine 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 for stuck instrument buttons and footswitches A Unintentional input Check that nothing is bumping against the touchscreens Please check the following Object touching the screen Instrumentfaotpedal unintentionally activated REM Alarm Refer to the REM Alarms in this chapter LigaSure Check Instrument Alert Refer to Alert Situations in Chapter 6 A Check Instrument Regrasp thicker tissue ZR Reinsert electrodes Check for clips Regrasp tissue Clean electrode tips gt Remove excess fluids Sf Regrasp and Reactivate ForceTriad User s Guide 7 7 Bunoouse qnoj System Alarms Description or Screen Solution LigaSure Endpoint Not Reached Alert ANB eactivate Endpoint not reached Seal cycle interrupted Reactivate S R Refer to Alert Situations in Chapter 6 Dual Instrument Alert Invalid Instrument Alert Invalid instrument Disconnect one instrument connected under associated screen Disconnect invalid instrument Use appropriate instrument Refer to ins
33. and Blend In the coag mode the waveforms available are Fulgurate or Spray 2 Setthe power to the desired output level by pressing either the green up or down arrows Power output is displayed in watts ForceTriad User s Guide Active Electrodes 3 Activate the cut mode by pressing the yellow button on the electrosurgical instrument The cut display will illuminate yellow and a tone will sound 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 of the activation Valleylab Mode Functionality Valleylab instruments featuring the Valleylab mode are specialty devices that enable the surgeon to control ForceTriad energy platform output from the sterile field Three output modes are selected at the handset with the following buttons The yellow cut button enables a cutting function The clear Valleylab button enables a hemostasis function while providing dissection e blue coag button enables a coagulation function A dual slider control switch 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 instrument type and displays the Valleylab tab on the corresponding touchscreen Power Output Modes Power Zone Watts Indicators
34. b clause 36 202 3 1 and IEC 61000 4 4 Surge Immunity IEC 60601 1 2 sub clause 36 202 3 2 and IEC 61000 4 5 Emissions IEC 60601 1 2 sub clause 36 201 1 IEC 60601 2 2 sub clause 36 and CISPR 11 Class A Harmonic distortion 60601 1 2 sub clause 36 201 3 1 and 61000 3 2 Conducted disturbances IEC 60601 1 2 sub clause 36 202 6 and IEC 61000 4 6 Power frequency magnetic fields IEC 60601 1 2 sub clause 36 202 8 1 and IEC 61000 4 8 Voltage dips short interruptions and variations 60601 1 2 sub clause 36 202 7 and IEC 61000 4 11 9 12 ForceTriad User s Guide Output Characteristics Output Characteristics Maximum Output for Bipolar Monopolar and LigaSure Modes Power readouts agree with actual power into rated load to within 1596 or 5 watts whichever is greater Mode Open Circuit Peak Open Circuit P P Rated Load Power Crest Duty Voltage max Voltage max max max Factor Cycle Bipolar Low 250 V 500 V 1000 95 W 1 42 N A Standard 175 350 V 1000 95 1 42 Macro 250 V 500 V 1000 95 W 1 42 N A Monopolar Cut Cut 920 V 1840 V 300 Q 300W 1 42 N A Blend 1485 V 2970 V 300 Q 200W 2 7 5096 Valleylab HWD 2365 V 4730 V 300 O 200W 4 3 2596 Monopolar Coag Fulgurate 3050 V 6100 V 500 Q 120W 5 55 6 596 Spray 3625 V 7250V 500 Q 120W 6 6 4 6 LigaSure 287 5 V 575 200 350 W 1 42 An indication of a waveform s ability to coagulate bleeders without a cutting e
35. ceTriad energy platform for different line frequencies Input Current The ForceTriad energy platform draws no more than 10A at any line input voltage Backup Power The ForceTriad energy platform retains all user programmed features calibration and statistical data when switched off and unplugged The ForceTriad energy platform operates within specification when switched over to a supplied line power by hospital backup systems Equipotential Ground Connection An equipotential ground connection is provided to allow connection of the ForceTriad energy platform to ground ECG Blanking An ECG blanking port is provided to signal other devices that the ForceTriad energy platform is active The receptacle is a 2 5 mm mono jack It is electrically isolated from the internal ground referenced electronics with the shell electrically connected to the chassis for ESD protection 9 8 ForceTriad User s Guide Standards and IEC Classifications Standards and IEC Classifications The ForceTriad energy platform meets all pertinent clauses of the IEC 60601 1 second edition and IEC 60601 2 2 third edition gt Ce TS NS o t MEDICAL EQUIPMENT L 60601 1 CAN CSA C22 2 NO 601 1 47AK E199592 5 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 shock do not
36. chscreen will display an alert message that instructs the user on the corrective actions to take When an alert condition occurs energy delivery will be interrupted but will be available immediately after the alert condition has been corrected The two alert conditions are Check Instrument A six pulsed tone will sound when the Check Instrument screen is displayed If this message appears the user should 1 Release the footswitch pedal or activation button 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 location then reactivate the seal cycle A Check Instrument Regrasp thicker tissue ZR Reinsert electrodes pm Check for clips Regrasp tissue gt Clean electrode tips gt Remove excess fluids Sef Regrasp and Reactivate Regrasp thicker tissue Thin tissue open the jaws and confirm that a sufficient amount of tissue is inside the jaws If necessary increase the amount of tissue and repeat the procedure Reinsert electrodes Electrodes may have become dislodged from the instrument Check for clips Regrasp tissue Avoid grasping objects such as staples clips or encapsulated sutures in the jaws of the instrument Clean electrode tips Use a wet gauze pad to clean surfaces and edges of instrument jaws Remove excess fluids
37. cking due to longer dessication periods 1 You may adjust the instrument setting by touching one of the three setting buttons on the respective LigaSure 1 or LigaSure 2 control panel The button touched along with the buttons to the left of it become green and the standby button turns grey 2 Asasafety feature you may set the ForceTriad energy platform on standby until you are ready for surgery by pressing the standby button O When on standby no energy will be delivered through the LigaSure instrument If you attempt to activate a LigaSure instrument a single short tone will sound 3 To bring the energy platform out of standby press a desired bar setting Previous bar settings will not be stored in standby Activating the LigaSure Instrument 1 Activate the LigaSure instrument either by pressing and holding the activation button on the instrument or by stepping on and holding the footswitch pedal During instrument activation the status bar in the corresponding LigaSure control panel illuminates blue and an activation tone sounds for the duration of energy delivery 2 When the end tone is heard you may release the activation button or footswitch pedal In the case of an alert condition refer to the following section ForceTriad User s Guide uoisn 4 enssi Activating the LigaSure Instrument Alert Situations A pulsed tone will sound when an alert condition occurs and the LigaSure tou
38. cluding bowel perforation and unintended irreversible tissue necrosis Always use the lowest power setting that 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 burn injury has occurred during procedures in small surgical fields and on small appendages Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the current flow and the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures Do not wrap the instrument cords or patient return electrode cords around metal objects This may induce currents that could lead to shocks fires or injury to the patient or surgical team Electric Shock Hazard Do not connect wet instruments to the energy platform Ensure that all instruments and adapters are correctly connected and that no metal is exposed at any connection points Confirm proper power settings before proceeding with surgery If the proper power settings are not known set the power to a low setting and cautiously increase the power until the desired effect is achieved If increased power settings are requested check the patient return electrode and all instrument connections before major power setting adjustments 2 2 ForceTriad Use
39. e When this energy platform is used in procedures where conductive fluid saline or lactated Ringers is introduced into the surgical site for distention or to conduct RF current higher than normal currents greater than one amp may be produced In this situation use one or more adult size return electrodes Do not use return electrodes labeled for children infants babies neonatal use or pediatric use Use of duty cycles greater than 2596 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 continuously activate for longer than one minute ForceTriad User s Guide 2 11 Kayes pue Laparoscopic Procedures Laparoscopic Procedures For laparoscopic procedures be alert to these potential hazards Laparoscopic surgery may result in gas embolism due to insufflation of gas in the abdomen The electrode tip may remain hot enough to cause burns after the electrosurgical current is deactivated Inadvertent activation or movement of the activated electrode outside of the field of vision may result in injury to the patient Localized burns to the patient or physician may result from electrical currents carried through conductive objects such as cannulas or scopes Electrical current may be generated in conductive objects through direct contact with the active elect
40. e following steps for general preparation To find detailed directions for each instrument please refer to the individual instrument instructions that accompany each instrument electrode 1 Slip the base of the disposable electrode s white shaft onto the retaining post on the instrument ring handle 2 Snap the body of the white electrode shaft onto the instrument handle The white shaft of the electrode must be completely flush on the reusable instrument shaft 3 Snap each electrode into the appropriate instrument jaw matching electrode curvature to jaw curvature Insert the proximal pin first Verify that there is no gap between the electrode and the instrument jaw Note Bent or broken electrode pins will not function properly and may result in an alert situation In this case the electrode must be discarded 4 Gently ratchet the instrument 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 LigaSure 2 receptacle on the front panel of the ForceTriad energy platform The system detects the instrument type and sets the appropriate bar setting in the display If you have entered settings in the LigaSure touchscreen prior to connecting a LigaSure instrument these settings will be reset Invalid Instrument If the ForceTriad energy platform does not recognize the attached instrument the
41. e possible To minimize the risk take these precautions Do not buzz the hemostat with a needle electrode Do not lean on the patient the table or the retractors while buzzing the hemostat Activate cut rather than coag Cut has a lower voltage than coag Firmly grasp as much of the hemostat as possible before activating the energy platform This disperses the current over a larger area and minimizes the current concentration at the finger tips Buzz the hemostat below hand level as close as possible to the patient to reduce the opportunity for current to follow alternate paths through the surgeon s hands Use the lowest power setting possible for the minimum time necessary to achieve hemostasis Activate the energy platform after the instrument makes contact with the hemostat Do not arc to the hemostat When using a coated or nonstick blade electrode place the edge of the electrode against the hemostat or other metal instrument ForceTriad User s Guide Kayes pue juaijed Monopolar Patient Return Electrodes Do not attempt to use patient return electrodes that disable the REM system The ForceTriad energy platform s REM system will function correctly only with contact quality monitoring COM split style patient return electrodes Any other patient return electrode products may cause patient injury or product damage The safe use of monopolar electrosurgery
42. ealing System year from date of shipment LigaSure Reusable Instruments year from date of shipment Mounting Fixtures all models One year from date of shipment Footswitches all models One year from date of shipment Force Argon Units One year from date of shipment OptiMumm Smoke Evacuator Two years from date of shipment LigaSure Sterile Single Use Items Sterility only as stated on packaging Sterile Single Use Items Sterility only as stated on packaging Patient Return Electrodes Shelf life only as stated on packaging This warranty is in lieu of all other warranties express or implied including without limitation the warranties of merchantability and fitness for a particular purpose and of all other obligations or liabilities on the part 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 provision herein or in any other document or communication Valleylab s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Valleylab to the customer There are no warranties which extend beyond the terms hereof Valleylab disclaims any liability hereunder or elsewhere in connection with the sale of this product for indirect or consequential damages ForceTriad User s Guide This warrant
43. eck with the manufacturer of the monitor Some manufacturers offer RF choke filters for use in monitor leads The filters reduce interference when the energy platform is activated and minimize the potential for an electrosurgical burn at the site of the monitor electrode Pacemaker interference Intermittent connections or metal to metal sparking Current traveling from active to return electrode during monopolar electrosurgery is passing too close to pacemaker Check the active and patient return electrode cord connections It may be necessary to reprogram the pacemaker Consult the pacemaker manufacturer or hospital cardiology department for further information when use of electrosurgical appliances is planned in patients with cardiac pacemakers Use bipolar instruments if possible If you must use a monopolar instrument place the patient return electrode as close as possible to the surgical site Make sure the current path from the surgical site to the patient return electrode does not pass through the vicinity of the heart or the site where the pacemaker is implanted Always monitor patients with pacemakers during surgery and keep a defibrillator available Internal Cardiac Defibrillator ICD activation ICD is activated by energy platform Stop the procedure and contact the ICD manufacturer for instructions 7 6 ForceTriad User s Guide System Alarms System Alarms Most system
44. er s Guide 7 3 unooysejgnoJg Correcting Malfunctions Situation Possible Cause Solution Energy platform is on and instrument is activated but system does not deliver output Malfunctioning footswitch or handswitching instrument Turn off the energy platform Check and correct all instrument connections Turn on the energy platform Replace the instrument if it continues to malfunction Power is set too low Increase the power setting An alarm condition exists Note the code along with all information on the error screen Note the number and refer to System Alarms later in this chapter In case of a REM alarm refer to Correcting a REM Alarm Condition earlier in this chapter Internal 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 LigaSmart connector into the appropriate receptacle on the energy platform front panel Ensure the vessel fusion touchscreen indicates that it has detected the instrument System does not detect monopolar instrument System does not detect bipolar instrument Firmly insert the Smart connector into the appropriate receptacle on the energy platform front panel Ensure the monopolar touchscreen indicates that it has detected the instrument Firmly insert the connector into the appropriate
45. er s Guide vii oerviee Display DEDE 3 3 ic slic rm Hd M EE E c dE 3 3 STU o HE P 3 3 DG IMO 2 TC FR RH RP RH 3 5 Chapter 4 Monopolar Function Front Panel Monopolar Features e eec eei a ta sm atas m 4 2 Rear Panel Monopolar Features 9 2 9 2 9 2 0 onn o seinen esee nnnm tn ALL 4 2 Monopolar Quick Setup 5 5 4 3 Monopolar Function 0 7 gt 4 4 Monopolar Power Output Modes 4 4 FOOTSWITCH 4 4 Return Electrodes REM Contact Quality Monitoring System eese 4 5 Patient Return Electrode Considerations 4 5 How the REM System 4 5 Patient Return Electrode Setup eee ies seeseese tn sn snam stata snas 4 6 Active 4 8 Standard Monopolar Mode Functionality eese n r tnnt 4 8 Valleylab Mode Functionality instr antra nn 4 9 Using a Valleylab Mode Instrument eese nennen nnne nntn nnnm ntn i
46. ery operated Do not use needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may result To reduce the risk of an inadvertent electrosurgical burn at the electrode or probe site place the electrode and or probe as far away as possible from the electrosurgical site and or patient return electrode Protective impedances resistors or RF inductors installed in the monitoring leads may reduce the risk of such burns Consult the hospital biomedical engineer for further information 2 8 ForceTriad User s Guide Bipolar LigaSure In some circumstances the potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when electrosurgical current seeks a path to the patient return electrode that includes the skin to skin contact point Current passing through small skin to skin contact points is concentrated and may cause a burn This is true for ground referenced and isolated output electrosurgical energy systems To reduce the potential for alternate site burns do one or more of the following Avoid skin to skin contact points such as fingers touching leg or knee touching knee when positioning the patient Place insulation such as dry gauze or towel between contact points to ensure that contact does not occur Position the patient return electrode to provide a direct current route between t
47. es of power output Cut Modes Pure cut provides a clean precise cut in any tissue with little or no hemostasis Blend cut is a conventional blended waveform that provides slower cutting and additional hemostasis Valleylab Mode Valleylab mode is a unique combination of hemostasis and dissection and allows the user to slow down for more hemostasis and speed up for faster dissection Thermal spread is equal or superior to Cut or Blend modes Coag Modes Fulgurate coagulates tissue by sparking from the active electrode through air to the patient 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 areas can occur as tissue at the surgical site dries and becomes more resistant to current flow Spray delivers wider fulguration penetration is shallower and the affected tissue area is larger than with the Fulgurate mode Bipolar Modes Three bipolar modes are available Low Standard and Macrobipolar Low delivers precision and fine control over the amount of desiccation Standard is a conventional bipolar output at low voltage Macro Macrobipolar may be used for bipolar cutting or rapid coagulation Power remains constant over a wide range of tissue types Autobipolar The autobipolar feature senses tissue impedance between the two bipolar electrodes then uses the impedance information
48. ffect ForceTriad User s Guide 9 13 suomneouioeds eoiuuo9 Output Characteristics Available Power Settings in Watts Bipolar and Autobipolar All Modes 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 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 95 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 290 300 Monopolar Blend 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 95 100 110 120 130 140 150 160 170 180 190 200 9 14 ForceTriad User s Guide Output Characteristics Valleylab 1 2 3 4 2 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 95 100 110 120 130 140 150 160 170 180 190 200 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 ForceTriad User s Guide 9 15 suomneouioeds eoiuuo9 Output Characteristics Output Waveforms Tissue Sensing Technology an automatic adjustment controls all modes As tissue resistance increases from zero t
49. ge 85 132 Vac Input mains voltage operating range 170 264 Vac Mains current maximum Idle 0 4 A Bipolar 2 0 A Cut 7 0 A Coag 4 0A LigaSure 5 0 Mains current maximum Idle 0 2 A Bipolar 1 0 A Cut 3 5 A Coag 2 0A LigaSure 2 5 A Mains line frequency range nominal 50 Hz to 60 Hz Mains line frequency range nominal 50 Hz to 60 Hz Fuses 2 5 mm x 20 mm 8A 250 V fast blow Fuses 2 5 mm x 20 mm 8A 250 V fast blow Power cord 3 prong hospital grade connector Power cord 3 prong locally approved connector ForceTriad User s Guide suomneouioeds eoiuuoo Performance Characteristics Power Cord Specification This unit was equipped from the factory with a 110 VAC hospital grade NEMA 5 15 power cord Should the AC power cord need to be replaced to match another plug configuration the replacement plug cable receptacle configuration must meet or exceed the following specifications 100 120 VAC Cable SJT16 3 IEC color code maximum length 15 ft 5 m Plug minimum 10 A 125 VAC Unit receptacle IEC female minimum 10 A 125 VAC 220 240 VAC Cable HO5VVF3G1 0 VDE maximum length 15 ft 5 m Plug minimum 6 A 250 VAC Unit receptacle IEC female minimum 6 A 250 VAC Input Frequency The ForceTriad energy platform operates within specification at all line input frequencies between 48 Hz and 62 Hz The User does not need to reconfigure the For
50. ge footswitch icon to the right of it This receptacle accepts all Valleylab LigaSure instruments and can read either the dot patterns or bar codes on the LigaSmart connector Instruments attached to the LigaSure 2 receptacle are controlled from the lower orange section of the LigaSure touchscreen ForceTriad User s Guide Footswitch Footswitch Start System Electric Shock Hazard Do not connect wet instruments to the energy platform Ensure that all instruments are correctly connected and that no metal is exposed at any connection point Connect instruments to the proper receptacle Improper connection may result in inadvertent instrument activation or other potentially hazardous conditions Follow the instructions provided with LigaSure instruments for proper connection and use The instrument receptacles on this system are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Read the instructions warnings and cautions provided with LigaSure instruments before use Specific instructions are not included in this manual Inspect instruments and cords especially reusable instruments and cords for breaks cracks nicks and other damage before every use If damaged do not use Failure to observe this precaution may result in injury or electrical shock
51. he energy platform outputs constant current followed by constant power followed by constant voltage The maximum output voltage is controlled to reduce capacitive coupling and video interference and to minimize sparking Bipolar Low Standard Macro Monopolar Cut Cut Blend Valleylab Valleylab Monopolar Coag Fulgurate Spray 472 kHz sinusoid continuous 472 kHz sinusoid continuous 472 kHz sinusoid continuous 472 kHz sinusoid continuous 472 kHz bursts of sinusoid recurring at 26 21 kHz intervals 5096 duty cycle 472 kHz bursts of sinusoid recurring at 28 3 kHz intervals 2596 duty cycle 472 kHz damped sinusoidal bursts with a repetition frequency of 30 66 kHz 6 596 duty cycle 472 kHz damped sinusoidal bursts with a randomized repetition centered at 21 7 kHz 4 6 duty cycle 9 16 ForceTriad User s Guide Output Power vs Resistance Graphs Output Power vs Resistance Graphs Monopolar Graphs Pure Cut Output power versus impedance for Pure cut power T 300 250 200 5096 100 150 100 Output power watts 50 0 1000 2000 3000 4000 5000 Load Impedance ohms Output power versus power setting for Pure cut power 300 4 250 200 Cut Output Power 150 vs Setting 300ohm 100 Output power watts 50 100 200 300 Power Setting 1000 900 800 Peak
52. he return electrode site During a surgical procedure the amount of current delivered during a given time period determines the amount of heating that occurs under the return electrode Valleylab REM patient return electrodes are designed for use during conventional electrosurgical procedures and duty cycles on time compared to off time Users should consult the Technical Specifications chapter in this manual for the recommended maximum duty cycle specifications Itis not possible to foresee what combination of current and duty cycle may be safely used in every situation such as when higher currents and or longer duty cycles are used on procedures such as tissue lesioning tissue ablation tissue vaporization and procedures where conductive fluid is introduced into the surgical site Under these conditions a greater risk may exist that the heating under a fully applied return electrode may be high enough to injure 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 instructions from the manufacturer of the active accessory regarding the currents and duty cycles that can be expected In some instances the application of additional patient return electrodes may help mitigate the increased risk How the REM System Works The ForceTriad energy platform uses the Valleylab REM contact quality monitoring system t
53. he surgical site and the return electrode which avoids skin to skin contact areas In addition place patient return electrodes according to the manufacturer s instructions Bipolar instruments must be connected to the bipolar instrument receptacle only Improper connection may result in inadvertent system activation LigaSure instruments are intended for use ONLY with the Valleylab ForceTriad energy platform and the Valleylab LigaSure vessel sealing system Use of these instruments with other Valleylab generators or with generators produced by other manufacturers may not result in electrical output for which these instruments were designed and thus may not result in the desired clinical effect If the seal cycle complete tone has not sounded an optimal seal may not have been achieved Reactivate the RF energy until a seal complete tone is heard The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures Do not use this function for these procedures Use caution during surgical cases in which patients exhibit certain types of vascular pathology atherosclerosis aneurysmal vessels etc For best results apply the seal to unaffected vasculature Do not activate the energy platform in the LigaSure mode until the tissue fusion instrument has been applied with the proper pressure Activating the energy platform before this is done will result in an impro
54. hetics Fire Hazard not place active instruments near or in contact with flammable materials such as gauze or surgical drapes Electrosurgical instruments that are activated or hot from use can cause a fire When not in use place electrosurgical instruments in a safety holster or safely away from patients the surgical team and flammable materials 2 4 ForceTriad User s Guide General Fire Hazard Sparking and heating associated with electrosurgery can be an ignition source Keep gauze and sponges wet Keep electrosurgical electrodes away from flammable materials and oxygen Oz enriched environments Use of electrosurgery in O2 rich environments increases the risk of fire Therefore take measures to reduce the O2 concentration at the surgical site Avoid enriched O2 and nitrous oxide N2O atmospheres near the surgical site Both O2 N2O support combustion and may result in fires and burns to patients or surgical personnel If possible stop supplemental oxygen at least one minute before and during use of electrosurgery Do not activate the energy platform until flammable vapors from skin prep solutions and tinctures have dissipated Avoid the accumulation of naturally occurring flammable gases that may accumulate in body cavities such as the bowel Prevent pooling of flammable fluids and the accumulation of flammable or oxidizing gases or vapors under surgical drapes or near the surgical site Tissue build
55. is precaution may result in injury or electrical shock to the patient or surgical team The ForceTriad energy platform in bipolar mode can accommodate a three pin single pedal bipolar footswitch If you plan to use a footswitching bipolar instrument attach the bipolar footswitch connector plug to the bipolar footswitch receptacle on the rear panel Bipolar Electrode Function 1 Connect a bipolar instrument to the bipolar instrument receptacle on the front panel Note The Bipolar touchscreen can control only one instrument at one time If more than one instrument is attached under this touchscreen an error message will display in the touchscreen Both devices will be inactivated until one of the devices is removed When a bipolar instrument is connected the bipolar tab displays on the center touchscreen Power Output Modes Green Power Watts Control Arrows Virtual Ammeter Power Output Mode Waveforms NS 2 Select the power output mode waveform by pressing the associated button at the bottom of the tab The waveforms available in the bipolar mode are Low Standard and Macro 3 Set the power to the desired output level by pressing the green up and down arrows Power output is displayed in watts 4 Activate the bipolar mode by closing the forceps firmly or by stepping on the single pedal footswitch An activation tone will sound and delivered current is displayed on the virtual ammeter ForceTriad User s Guide
56. l remain disabled until the REM alarm is corrected When you correct a REM alarm condition the system is enabled and the REM alarm indicator illuminates green Valleylab recommends the use of Valleylab REM patient return electrodes Return electrodes from other manufacturers may not provide proper impedance to work correctly with the ForceTriad energy platform Correcting a REM Alarm Condition To correct a REM alarm condition follow these steps 1 Inspect the return electrode plug and cord If you find evidence of cracks breaks or other visible damage replace the return electrode and or the cord 2 Verify that the patient return electrode cord is correctly connected to the energy platform 3 Verify that the return electrode is in good contact with the patient Follow the instructions for use provided with the Valleylab REM patient return electrode 4 If the REM alarm persists it may be necessary to use more than one patient return electrode Refer to the instructions for use with the Valleylab REM patient return electrode for complete information ForceTriad User s Guide Correcting Malfunctions Correcting Malfunctions If a solution is not readily apparent use the table below to help identify and correct specific malfunctions After you correct the malfunction verify that the system completes the self test as described in the System Setup chapter Situation Possible Cause Solution Abnormal neuromu
57. lab mode to lessen the potential for the creation of capacitive currents Carefully insert and withdraw active electrodes from cannulas to avoid possible injury to the patient or damage to the devices Valleylab recommends against the use of laparoscopic surgery on pregnant patients 2 12 ForceTriad User s Guide System Setup This chapter describes the how to set up the energy platform turn it on and configure system settings 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 ForceTriad User s Guide 3 1 Setup Setup System Functions Before Startup 1 Verify the system is off by pressing the power switch off O 2 Place the energy platform on a flat stable surface such as a table platform boom system or Valleylab cart Carts with conductive wheels are recommended Refer to the procedures for your local institution or your local codes 3 Plug the system power cord into the rear panel receptacle 4 Plug the system power cord into a grounded power receptacle Note Do not plug into a power strip or extension cord Powering Up the ForceTriad Energy Platform 1 Turn on the system by pressing the power switch on 1 Observe the following during the power up self test The
58. le instruments and cords for breaks cracks nicks and other damage before every use If damaged do not use Failure to observe this precaution may result in injury or electrical shock to the patient or surgical team The ForceTriad energy platform in the monopolar mode can accommodate a monopolar footswitch when used with the accompanying adapter This monopolar footswitch controls only those instruments connected to the accessory receptacle controlled by the left panel If you plan to use a footswitching monopolar instrument attach the monopolar footswitch adapter to the monopolar footswitch receptacle on the rear of the system Connect only Valleylab approved footswitches Using footswitches from other manufacturers may cause equipment malfunction 4 4 ForceTriad User s Guide Return Electrodes Contact Quality Monitoring System Return Electrodes REM Contact Quality Monitoring System Notice Only contact quality monitoring system patient return electrodes can be used with the ForceTriad energy platform Patient Return Electrode Considerations During monopolar electrosurgery a patient return electrode is always required to safely recover the current that flows through the patient s body and return it to the energy platform A reduction in surface area contact or poor conductivity between the patient and the return electrode can cause the current to become concentrated potentially resulting in burns at t
59. llow all directions on the product package for proper return electrode placement and use Do not cut a patient return electrode to reduce its size Patient burns due to high current density may result 1 Place the patient return electrode on the patient Refer to the patient return electrode instructions for proper return electrode placement 2 Connect the REM patient return electrode plug to the patient return electrode receptacle on the energy platform The REM indicator icon on the touchscreen 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 illuminates green when the system senses that the REM patient return electrode is properly connected to the energy platform and patient 4 6 ForceTriad User s Guide Return Electrodes Contact Quality Monitoring System 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 s REM Alarm Indicator 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 ForceT
60. n the right side of the right touchscreen The main menu display will appear in the left touchscreen Touch Setup in the main menu The setup display will appear in the left touchscreen Touch the Time and Date button in the setup menu The time and date display will appear in the left touchscreen Touch the desired numeric field minutes seconds month day or year to select that field Touch the up or down arrows next to the time or date row to adjust the selected numeric field Touch and hold the arrows to increase the number once per second After four seconds the numbers will increase once per 100 milliseconds Touch the 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 menu Touch the green arrow button below the setup menu to return to the main menu Enable Disable Autobipolar 1 Touch the wrench icon on the right side of the right touchscreen The main menu display will appear in the left touchscreen Touch Setup in the main menu The setup menu will appear in the left touchscreen If the Autobipolar mode is not enabled the Autobipolar button will display Enable Autobipolar Touch the Enable Autobipolar button to enable the Autobipolar mode If the Autobipolar mode is enabled the Autobipolar button will display Disable Autobipolar Touch the Disable
61. nclosure or display quality Valleylab recommends that authorized Valleylab personnel service the ForceTriad energy platform however some service operations can be performed by qualified biomeds Returning the Energy Platform for Service Before you return the energy platform 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 Valleylab Customer Service Center for your area to obtain a Return Authorization Number Have the following information ready when you call e Hospital clinic name customer number e Your telephone number e Department address city state and zip code Model number e Serial number Description of the problem Type of repair to be done 2 Clean the energy platform See the Cleaning section above ForceTriad User s Guide pue Adjustment to Factory Specification Calibration 3 Ship the energy platform a Attach a tag to the energy platform that includes the return authorization number and the information hospital phone number etc listed in step 1 b Be sure the energy platform is completely dry before you pack it for shipment Package it in its original shipping container if available c Ship the energy platform prepaid to the Valleylab Service Center Adjustment to Factory Specification Calibration
62. nds inactive in any mode for a period of 4 hours Use of duty cycles greater than 2596 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 continuously activate for longer than one minute Low Frequency 50 60 Hz Leakage Current Enclosure source 300 current ground open Source current patient Normal polarity intact ground 10 seeds aloulputs Normal polarity ground open lt 50 uA Reverse polarity ground open 50 uA Mains voltage on applied part 50 Sink current at high lt 50 pA line all inputs 9 6 ForceTriad User s Guide Performance Characteristics High Frequency RF Leakage Current Measured with leads Measured directly at the recommended by Valleylab energy platform terminals Bipolar lt 59 2 ms RF leakage current Monopolar RF leakage current lt 150 mA rms LigaSure leakage lt 132 mA rms Input Power 100 120 Volt lt 59 2 mA ms lt 100 mA rms lt 100 mA rms 220 240 Volt Maximum VA at nominal line voltage Idle 52 VA Bipolar 450 VA Cut 924 VA Coag 530 VA Maximum VA at nominal line voltage Idle 52 VA Bipolar 450 VA Cut 924 VA Coag 530 VA Input mains voltage full regulation range 90 132 Input mains voltage full regulation range 208 264 Vac Input mains voltage operating ran
63. nitial measured contact resistance increases by 4096 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 illuminated red and yellow until you correct the condition causing the alarm Then the indicator illuminates green and RF output is enabled Autobipolar The ForceTriad energy platform is equipped with an autobipolar feature that allows for automatic activation of bipolar energy Note The autobipolar electrode function requires the use of the Valleylab E0018 bipolar instrument cord The autobipolar specifications are Interrogation frequency 80 kHz 10 kHz Interrogation current 100 Interrogation voltage 12V RMS Activation impedance 20 O to 500 Q ForceTriad User s Guide suomneouioeds eoiuu29 Performance Characteristics Deactivation impedance User selectable 1 500 O 1 800 O 2 000 O or 2 200 O Measurement accuracy 1495 of Full Scale activation impedance while keying active above 10 watts 5090 14 of full scale activation impedance while keying active at 10 watts or below 596 of Full Scale activation impedance while keying inactive Keying delay User selectable in 500 msec increments from 0 sec to 2 5 sec Duty Cycle Under maximum power settings and rated load conditions the ForceTriad energy platform is capable of operating a duty cycle of 2596 defined as 10 seconds active and 30 seco
64. nn tn ann tn intranet 4 10 Manual Power Control Functionality 4 11 Port FUNCTIONALILY ne 4 12 Chapter 5 Bipolar Surgery Front Panel Bipolar Features sssini atas masas masas asma asma nL a 5 2 Rear Panel Bipolar Features 1 bin nEn EANAN 5 2 Bipolar Quick Setup Instructions eere eene entente tnter tenete tnn 5 3 Bipolar Function B Au p 5 3 Bipolar Power Output Modes 4 4 44444249424294227272 ies esesesesn eme te tate tna LEE tnam etat ata sn ameta 5 3 FOOtswitch MMC ED 5 4 Bipolar Electrode Function eee MANE Neia 5 4 Autobipolar Electrode FUN Ct OM ceiciccccicecctsscccteccncscentsecasecectenectvecstctectetecccteeccussetuteerdtedentenesdtetenstedcurtedtettecrdteccaintes 5 5 Chapter 6 LigaSure Tissue Fusion Front Panel LigaSure 6 2 Rear Panel LigaSure Features eee iie ieesieseesenese seen enata tnnt ta ta tn smash ta 6 2 LigaSure Quick Setup Instructions erre eere rere nn nnr ta tuta ta tata tata tata tata nn nn nno 6 3 LigaSure Function
65. nterference produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely Consult the pacemaker manufacturer or hospital cardiology department for further information when use of electrosurgery or tissue fusion appliances is planned in patients with cardiac pacemakers If the patient has an implantable cardioverter defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical or tissue fusion procedure Electrosurgery or tissue fusion may cause multiple activations of ICDs 2 6 ForceTriad User s Guide Monopolar Monopolar After Surgery Warning Electric Shock Hazard Always turn off and unplug the energy platform before cleaning Do not reprocess reuse or resterilize instruments labeled disposable or single use only Notice Do not clean the energy platform with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the energy platform Warning Simultaneously activating suction irrigation and electrosurgical current may result in increased arcing at the electrode tip burns to unintended tissues or shocks and burns to the surgical team Some surgeons may elect to buzz the hemostat during surgical procedures It is not recommended and the hazards of such a practice probably cannot be eliminated Burns to the surgeon s hands ar
66. o monitor the quality of electrical contact between the patient return electrode and the patient The REM system is designed to reduce the risk of burns at the return electrode site A non REM return electrode is not to be used with the ForceTriad energy platform The REM system continuously measures the resistance at the return electrode site and compares it to a standard range of safe resistance between 5 and 135 ohms thus eliminating intermittent false alarms that could result from small changes in resistance The REM system also adapts to individual patients by measuring the initial contact resistance between the patient and the patient return electrode and lowering the baseline resistance if the contact resistance drops A REM alarm sounds and the system stops producing output power when either of the following occurs The measured resistance is below 5 ohms or above 135 ohms the limits of the standard range of safe resistance An increase in contact resistance is greater than 4090 from the baseline measurement ForceTriad User s Guide uonoun 4 1ejodouo A Return Electrodes REM Contact Quality Monitoring System Patient Return Electrode Setup The REM indicator icon appears on the Standard Monopolar EL Valleylab and Accessory Port displays The safe use of monopolar electrosurgery requires proper placement of the patient return electrode To avoid electrosurgical burns beneath the patient return electrode fo
67. olar functionality touch the green Bipolar button The bipolar tab will replace the autobipolar tab or Turn the system off The next time the system is turned on it will default to the bipolar function and the bipolar tab will be visible 5 6 ForceTriad User s Guide LigaSure Tissue Fusion This chapter describes how to set up and operate the LigaSure tissue fusion function of the ForceTriad energy platform 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 ForceTriad User s Guide 6 1 Front Panel LigaSure Features Front Panel LigaSure Features LigaSure Touchscreen A ZroncE TRAD Purpl FMIple A 6 24 Monopolar 1 Monopolar 2 A LigaSure 1 AN iw A 9 E Orange 2 e o 7 we LJ E LigaSure 1 LigaSure 2 Power Switch Rear Panel LigaSure Features Receptacle Receptacle purple purple Monopolar h CAUTION eo Warning Risk of Fire Re
68. out removing or repositioning the instrument Continuous monitor interference Malfunctioning monitor Replace the monitor Faulty chassis to ground connections Check and correct the chassis ground connections for the monitor and for the energy platform Check other electrical equipment in the room for defective grounds Electrical equipment is grounded to different objects rather than a common ground The energy platform may respond to the resulting voltage differences between grounded objects Plug all electrical equipment into line power at the same location Contact your biomedical engineering department or a Valleylab technical Service representative for assistance ForceTriad User s Guide 7 5 Correcting Malfunctions Situation Possible Cause Solution Interference with other devices only when the energy platform is activated Metal to metal sparking Check all connections to the energy platform patient return electrode and instruments High settings used for fulguration Use lower power settings for fulguration Electrically inconsistent ground wires in the operating room Verify that all ground wires are as short as possible and go to the same grounded metal If interference continues when the energy platform is activated the monitor is responding to radiated frequencies Ask your biomedical engineering department to ch
69. ovides precise energy delivery and electrode pressure to tissues for a controlled time period to achieve a complete and permanent fusion of tissues and vessel lumens The system has been designed to produce minimal sticking charring or thermal spread to adjacent tissue The LigaSure touchscreen is divided into two functional parts the LigaSure 1 control panel which controls instruments connected to the LigaSure 1 receptacle and the LigaSure 2 control panel which controls instruments connected to the LigaSure 2 receptacle Two LigaSure instruments can be set up at one time through this touchscreen but only one instrument can be activated at one time During instrument 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 is located directly below the LigaSure touchscreen and is surrounded by a purple color bar with a purple footswitch icon to the right of it This receptacle accepts all Valleylab LigaSure instruments and can read either the dot patterns or bar codes on the LigaSmart connector Instruments attached to the LigaSure 1 receptacle are controlled from the upper purple section of the LigaSure touchscreen LigaSure 2 Receptacle The LigaSure 2 receptacle is located directly below the LigaSure 1 receptacle under the LigaSure touchscreen and is surrounded by a purple color bar with an oran
70. per seal and may increase thermal spread to tissue outside the surgical site ForceTriad User s Guide 2 9 hayes pue juaijed LigaSure Tissue fusion requires the application of RF energy and pressure from the instrument Tissue to be sealed must be firmly grasped between the instrument jaw electrodes Tissue in the jaw hinge or outside the instrument jaw will not be sealed even if thermal blanching occurs Do not use LigaSure instruments on vessels in excess of 7 mm in diameter LigaSure instruments that require single use electrodes must be used with the correct electrode type Use of these instruments with any other electrodes could result in injury to the patient or surgical team or cause damage to the instrument Conductive fluids e g blood or saline in direct contact with LigaSure instruments or in close proximity may carry electrical current or heat which may cause unintended surgical effects or burns Energy based devices such as electrosurgical 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 LigaSure in Laparoscopic Procedures For laparoscopic procedures be alert to these potential hazards The external surfaces of the LigaSure instrument jaws may remain hot enough to cause burns after the RF current is deactivated Inadvertent
71. place Fuse as Marked 250V F8 0A 100 240 Y Wa U S and foreign patents pending LigaSure 2 Footswitch LigaSure 1 Footswitch Receptacle orange Receptacle purple 6 2 ForceTriad User s Guide LigaSure Quick Setup Instructions LigaSure Quick Setup Instructions If you are familiar with the ForceTriad energy platform you may follow this abbreviated procedure to setup the system for LigaSure tissue fusion If you are not familiar with the ForceTriad energy platform refer to the following sections in this chapter for detailed instructions 1 2 Plug the system power cord into the rear panel receptacle Plug the system power cord into a grounded wall receptacle Note Do not plug into a power strip or extension cord Turn on the system and verify that the self test has successfully completed If using a footswitch connect it to the appropriate LigaSure footswitch receptacle on the rear panel Connect the instrument or instruments to the LigaSure instrument receptacles on the front panel Verify the bar setting ForceTriad User s Guide uoisn 4 enssi LigaSure Function Overview LigaSure Function Overview Purple m2 LigaSure 1 LigaSure 2 Orange The LigaSure tissue fusion mode can be used on arteries veins and lymphatics up to and including 7 mm in diameter and tissue bundles This system pr
72. r s Guide General Contact between the active electrode and any metal will greatly increase current flow and can result in unintended surgical effect While using electrosurgery the patient should not be allowed to come into direct contact with grounded metal objects e g surgical table frame instrument table etc If this is not possible during certain procedures e g those in which noninsulated head frames are used use extreme caution to maximize patient safety Use the lowest power setting that achieves the desired effect Place the patient return electrode as close to the surgical site as possible Place dry gauze between the patient and the grounded object if possible Continually monitor the contact point s Do not use metal needle monitoring electrodes Read all warnings cautions and instructions provided with this energy platform before using Read the instructions warnings and cautions provided with electrosurgical instruments before using Specific instructions for electrosurgical instruments are not included in this manual For surgical procedures where the current could flow through delicate parts of the body the use of bipolar techniques may be desirable in order to avoid unwanted coagulation Examine all instruments and connections to the system before using Ensure that the instruments function as intended Improper connection may result in arcs sparks instrument malfunction or unintended
73. receptacle on the energy platform front panel Ensure the bipolar touchscreen indicates that it has detected the instrument 74 ForceTriad User s Guide Correcting Malfunctions Situation Possible Cause Solution CHECK INSTRUMENT screen appears a six pulsed tone sounds and RF output is disabled Excessive tissue eschar on electrode tips or jaws Electrodes have come loose from the instrument jaws Electrode pins may have been compromised or bent during assembly to the instrument and may need to be replaced Clean electrode tips and jaws with a wet gauze pad Re insert the electrode into the instrument jaws making sure that all the electrode pins are firmly seated Metal or other foreign object is grasped within jaws Avoid grasping objects such as staples clips or encapsulated sutures in the jaws of the instrument Tissue grasped within jaws is too thin Open the jaws and confirm that a sufficient amount of tissue is inside the jaws If necessary increase the amount of tissue and repeat the procedure Pooled 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 handswitch or footswitch was released before the end tone activated Additional time and energy are needed to complete the fusion cycle Reactivate the seal cycle with
74. reens will display the last settings entered prior to shutting the system off Setup The setup menu allows the user to change the language that the system touchscreens display set the time and date and enable or disable the Autobipolar mode Language Setup 1 Touch the wrench icon on the right side of the right touchscreen The main menu display will appear in the left touchscreen 2 Touch 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 arrows to the right of the list to scroll through the list one line at a time or Touch the double up or down arrows to scroll through the list one page at a time 5 Touch the desired language confirmation box will appear and request the user to confirm that a language change is desired 6 To proceed with the language change touch the green check mark button The language will be activated and the confirmation box will close or To reject the language change touch the red X button The language setting will return to the previously selected language 7 Touch the green arrow button to return to the setup menu 8 Touch the green arrow button below the setup menu to return to the main menu ForceTriad User s Guide dnjes System Functions Time and Date Setup 1 Touch the wrench icon o
75. remove the cover Refer servicing to qualified service personnel Unit produces non ionizing radiation Classified with respect to electrical shock fire and mechanical hazards only in accordance with UL60601 1 and CAN CSA C22 2 No 601 1 ForceTriad User s Guide suoneoyioeds eoiuuo9 Symbols Symbols Monopolar instrument receptacle Monopolar footswitching receptacle Bipolar instrument receptacle LigaSure related receptacle footswitch Color coded LigaSure footswitch symbol for matching rear panel connector to front panel receptacle REM patient return electrode receptacle Volume adjustment for activation tones Equipotential grounding point Equipment should not be disposed in trash B 759 9 9 10 ForceTriad User s Guide Symbols Class Equipment IEC 60601 1 Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor Type CF Equipment IEC 60601 1 Defibrillator Proof This generator provides a high degree of protection against electric shock particularly regarding allowable leakage currents It is type CF isolated floating output and may be used for procedures involving the heart This generator complies with the ANSI AAMI 18 specifications for defibrillator proof designation and IEC 60601 2 2 Liquid Spillage IEC 60601 2 2 Clause 44 3
76. riad User s Guide Jejodouo N Active Electrodes Active Electrodes Connect a monopolar instrument to the Monopolar 1 or Monopolar 2 instrument receptacle on the front of the energy platform If a two button instrument is connected to the energy platform proceed to the Standard Monopolar Mode Functionality section below If a Valleylab mode enabled three button instrument is connected to the energy platform proceed to the Valleylab Mode Functionality section below Note The Monopolar 1 and Monopolar 2 touchscreens can each control only one instrument at one time If more than one instrument is attached under one touchscreen the error message pictured below will display in the touchscreen Both devices will be inactivated until one of the devices is removed Standard Monopolar Mode Functionality Power Output Mode Display Watts Green Power Power Output Control Arrows Mode Waveforms REM Indicator When a two button electrosurgical instrument is attached to either the Monopolar 1 or Monopolar 2 receptacle the ForceTriad energy platform detects the instrument type and displays the Standard Monopolar tab on the touchscreen The Standard Monopolar tab allows the user to control the power mode and power output level at the energy platform interface 1 Select the power output mode waveform by pressing the associated button at the bottom of the tab The waveforms available in the cut mode are Pure
77. rode or by the active instrument electrode or cable being in close proximity to the conductive object Do not use hybrid trocars that have a non conductive locking anchor placed over a conductive sleeve For the operative channel use all metal or all plastic Systems At no time should electrical energy pass through hybrid systems Capacitive coupling of RF current may cause unintended burns When using 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 occur in instances where the energy platform is activated for extended periods at high power levels inducing high current levels in the cannula Ensure that the insulation of single use and reusable laparoscopic instrumentation is intact and uncompromised Compromised insulation may lead to inadvertent metal to metal sparking and neuromuscular stimulation and or inadvertent sparking to adjacent tissue Do not activate electrodes while in contact with other instruments as unintended tissue injury may occur Do not activate the energy platform in an open circuit condition To reduce the chances of unintended burns activate the energy platform only when the active electrode is near or touching the target tissue Use the lowest power setting that achieves the desired surgical effect and use a low voltage waveform Pure Cut Blend or Valley
78. roperly evaluated for effectiveness and potential adverse consequences 6 10 ForceTriad User s Guide Troubleshooting 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 ForceTriad User s Guide 7 1 General Troubleshooting Guidelines General Troubleshooting Guidelines REM Alarms If the ForceTriad energy platform malfunctions check for obvious conditions that may have caused the problem e Check the system for visible signs of physical damage Make sure the fuse drawer is tightly closed e Verify that all cords are connected and attached properly If an error code is displayed on the touchscreens note the code along with all information on the error screen then turn the system off and turn it back on If the malfunction persists the system may require service Contact your institution s biomedical engineering department If the ForceTriad energy platform does not sense the correct impedance for the connected REM patient return electrode monopolar energy will be disabled the REM symbol will illuminate red and enlarge on both the center and left touchscreen displays and an alarm tone will sound twice The REM symbol will return to its smaller size but will remain red and RF energy wil
79. s When should the energy 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 to factory specifications When should the power cord be checked or replaced Check the power cord each time you use the energy platform or at the intervals recommended by your institution Replace the power cord if you find exposed wires cracks frayed edges or a damaged connector When should the fuses be replaced An internal component malfunction can damage the fuses You may need to replace the fuses if the system fails the self test or if the energy platform stops functioning even though it is receiving power from a wall outlet Refer to the service manual for instructions ForceTriad User s Guide Cleaning Cleaning Product Service Electric Shock Hazard Always turn off and unplug the energy platform before cleaning Notice Do not clean the energy platform with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the energy platform 1 Turn off the system and unplug the power cord from the wall outlet 2 Thoroughly wipe all surfaces of the energy platform and power cord with a damp cloth and mild cleaning solution or disinfectant The energy platform will withstand the effects of cleaning over time without degrading the e
80. s It features three touchscreen user interfaces and has the ability to automatically detect handsets and configure the generator accordingly Safety and diagnostic functionality include automatic fail safe functions The Valleylab ForceTriad energy platform patient return electrodes 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 When considering other manufacturers patient return electrodes and or active instruments customers should seek detailed user instructions and warning information from the manufacturer ForceTriad User s Guide System Conventions System Conventions Touchscreens The ForceTriad energy platform features a user friendly interface with three touchscreens that allow the user to control system functions 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 be displayed on a single A screen Up Down Pressing once increases decreases the associated value or moves highlighted selection up down one line Pressing and holding scrolls up down Next Back Progresses regresses to the next screen Regresses character ForceTriad User s Guide 1 3 pue
81. s with a cleaning agent and a damp cloth 3 Follow the procedures approved by your health care facility 4 Soak in an enzymatic cleaning agent such as Klenzyme or Enzol according to the manufacturer s instructions 5 Scrub all surfaces with a soft brush It is important that the jaw surfaces and instrument electrode holes are cleaned of blood and tissue to ensure proper electrode assembly 6 Rinse with water and dry with a soft cloth Sterilization Parameters The hinges on reusable LigaSure instruments are extremely tight and require longer sterilization times to ensure steam penetration into the hinge Steam Sterilization Wrapped Temperature Type Sterilize Time Dry Time 132 1389 C Prevac 10 min 20 min 270 2809 F 132 1389 Gravity 15 min 30 min 270 2809 F 121 1319C Gravity 30 min 30 min 250 2680 F Steam Sterilization Unwrapped Temperature Type Sterilize Time Dry Time 132 1389C Prevac 10 min 1 min 270 2809 F 132 138 C Gravity 15 min 1 min 270 280 F The instructions provided above have been validated by Valleylab as being capable of preparing LigaSure instruments for reuse It remains the responsibility of the processor to ensure that sterilization is performed using equipment materials and personnel that will achieve the desired results This requires validation and routine monitoring of the process Any deviation by the processor from the instructions provided should be p
82. scular stimulation stop surgery immediately Metal to metal sparking Check all connections to the energy platform patient return electrode and active electrodes Can occur during coag Use a lower power setting for the Fulgurate and the Spray modes Abnormal 50 60 Hz leakage currents Contact your biomedical engineering department or a Valleylab technical Service representative for assistance 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 functional outlet Faulty power cord Replace the power cord Fuse drawer is open or fuses are blown Replace the blown fuse s Close the fuse drawer Refer to the ForceTriad Energy Platform Service Manual Internal component malfunction Use a backup energy platform Contact your biomedical engineering department or a Valleylab technical Service representative for assistance System is on but did not complete the self test Software malfunction Turn off then turn on the system Internal component malfunction Note the code along with all information on the error screen Note the number and refer to System Alarms later in this chapter Use a backup energy platform Contact your biomedical engineering department or a Valleylab technical Service representative for assistance ForceTriad Us
83. tient return electrode to the patient and connect it to the patient return electrode receptacle on the front panel 6 Connect the instrument to the appropriate instrument receptacle on the front panel 7 Verify or change the mode and power settings ForceTriad User s Guide uonoun J 1ejodouo A Monopolar Function Overview Monopolar Function Overview Monopolar Footswitch Monopolar Power Output Modes The ForceTriad energy platform produces two cut modes Pure and Blend one Valleylab mode and two coag modes Fulgurate and Spray Electric Shock Hazard Do not connect wet instruments to the system Ensure that all instruments and adapters are correctly connected and that no metal is exposed at any connection point Connect instruments to the proper receptacle Improper connection may result in inadvertent instrument activation or other potentially hazardous conditions Follow the instructions provided with electrosurgical instruments for proper connection and use The instrument receptacles on this energy platform are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Read the instructions warnings and cautions provided with electrosurgical instruments before use Specific instructions are not included in this manual Inspect instruments and cords especially reusab
84. tion which if not avoided could result in death or serious injury Indicates a hazardous situation which if not avoided may result in minor or moderate injury Notice Indicates a hazard which may result in product damage Important Indicates an operating tip or maintenance suggestion ForceTriad User s Guide iii Warranty Valleylab a division of Tyco Healthcare Group LP warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period s set forth below Valleylab s obligation under this warranty is limited to the repair or replacement at its sole option of any product or part thereof which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser and which examination discloses to Valleylab s satisfaction that the product is defective This warranty does not apply to any product or part thereof which has been repaired or altered outside Valleylab s factory in a way so as in Valleylab s judgment to affect its stability or reliability or which has been subjected to misuse neglect or accident The warranty periods for Valleylab products are as follows ForceTriad Energy Platform One year from date of shipment Electrosurgical Generators One year from date of shipment RFG 3C Plus Lesion Generator One year from date of shipment LigaSure Vessel S
85. trument instructions for use for compatibility instructions 7 8 ForceTriad User s Guide Maintenance and Repair This chapter presents the following information The manufacturer s responsibility Routine maintenance Returning the energy platform for service Service centers 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 ForceTriad User s Guide 8 1 Responsibility of the Manufacturer Responsibility of the Manufacturer Routine Maintenance Valleylab is responsible for the safety reliability and performance of the energy platform only if all of the following conditions have been met Installation and setup procedures in this manual are followed e Assembly operation readjustments modifications or repairs are carried out by persons authorized by Valleylab The electrical installation of the relevant room complies with local codes and regulatory requirements such as IEC and BSI The equipment is used in accordance with the Valleylab instructions for use For warranty information refer to Preface chapter in this manual Notice Refer to the energy platform service manual for maintenance recommendations and function and output power verification procedure
86. ual mode the slider on the electrosurgical instrument is disabled and power can only be set at the touchscreen interface 1 To set the system into the manual mode press the green Manual button GD on the Valleylab tab touchscreen The manual control display will appear on the touchscreen 2 Adjust the power output for cut Valleylab mode and coag by pressing the associated green up or down buttons on the energy platform touchscreen 3 Toreturn to the sterile field control mode click on the X button The Valleylab mode control screen will re appear on the touchscreen and the power zone and slider position will reset based on the current instrument configuration ForceTriad User s Guide Jejodouo N Active Electrodes Accessory Port Functionality Instruments with 8 mm pins connect directly to the accessory port on the ForceTriad energy platform Instruments with pin diameters less than 8 mm require the use of an E0502 1 or E0017 Valleylab adapter Remove the adapter when not in use When a single pin electrosurgical instrument is attached to the universal footswitching accessory port the ForceTriad energy platform detects the instrument and displays the Accessory Port tab on the touchscreen The Accessory Port tab allows the user to control 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
87. up eschar on the tip of an active electrode 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 lubricating jelly may be used to cover hair close to the surgical site to decrease flammability Verify that all anesthesia circuit connections are leak free before and during use of electrosurgery Fire Hazard During Oropharyngeal Surgery Verify endotracheal tubes are leak free and that cuff seals properly to prevent oxygen leaks If an uncuffed tube is in use pack the throat with wet sponges around the uncuffed tube and be sure to keep sponges wet throughout the procedure Question the need for 10096 O2 during oropharyngeal or head and neck surgery If necessary scavenge excess O with separate suction Energy Platform Each instrument receptacle on this energy platform is designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a receptacle Doing so will cause simultaneous activation of the instruments Follow the instructions provided with electrosurgical instruments for proper connection and use Do not stack equipment on top of the energy platform or place the energy platform on top of electrical equipment This is an unstable configuration and does not allow for adequate cooling ForceTriad User s Guide 2 5 ha
88. voltage versus power setting for Pure cut power 700 600 500 400 300 200 100 Open Circuit Cut Peak Voltage vs Power setting Peak Voltage 0 100 200 300 Power Setting ForceTriad User s Guide 9 17 suomneouioeds eoiuuo9 Output Power vs Resistance Graphs Blend Output power versus impedance for Blend power 250 200 150 50 100 100 Output power watts 50 0 1000 2000 3000 4000 5000 Load Impedance ohms Output power versus power setting for Blend power Blend Output Power vs Setting 300ohm Output power wetts 0 50 100 150 200 Power Setting Peak voltage versus power setting for Blend power 1600 1400 1200 1000 800 Open Circuit Blend Peak Voltage vs Power Setting Peak Voltage 600 400 200 0 50 100 150 200 Power Setting 9 18 ForceTriad User s Guide Output Power vs Resistance Graphs Fulgurate Output power versus impedance for Fulgurate power 140 120 100 80 50 100 60 40 Output power watis 20 4 0 1000 2000 3000 4000 5000 Load Impedance ohms Output power versus power setting
89. wer watts 50 0 1000 2000 3000 4000 Load Impedance ohms Output power versus power setting for Valleylab power 200 180 160 140 120 Hemostasis w Division Output 100 power vs Power 80 Setting 300ohm 60 40 20 Output power watts 0 50 100 150 200 Power Setting 2500 lll 2000 1500 Open Circuit Valleylab Mode Peak Voltage vs Peak voltage versus power setting for Valleylab power Peek Voltage 1000 Power Setting 500 0 T 1 0 50 100 150 200 Power Setting suoneoyioeds eoiuuo9 ForceTriad User s Guide 9 21 Output Power vs Resistance Graphs Output power versus impedance for Bipolar Low power Output power versus power setting for Bipolar Low power Peak voltage versus power setting for Bipolar Low power Bipolar Graphs Bipolar Low Output power watts Output power watts Peak Voltage 100 90 80 70 60 50 50 40 100 30 90 80 70 60 50 40 30 20 10 250 200 150 100 50 500 1000 1500 2000 Load Impedance ohms Bip Low Output Power vs Setting 100 4 J 0 20 40 60 80 Power Setting Open Circuit Bipolar Low Peak Voltage vs Power Setting
90. y and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Colorado USA The sole forum for resolving 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 make changes in equipment built and or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and or sold by them ForceTriad User s Guide Kalleylab vi ForceTriad User s Guide Conventions Used in this Guide s 1 iii MW E iv Chapter 1 ForceTriad Energy Platform Overview and General Features ForceTriad Energy Platform Front 1 2 nus 1 2 I EACIEeNTIII 1 3 Mel L 1 3 Symbols ote iD ddin EI doni 1 3 Power 5 1 5 Monopolar MODGS 5 terrere 1 5 Bipolar FFR EN M 1 5 H 1 6 Chapter 2 Patient and Operating Room Safety General e e eiie e etta er rre 2
91. y stable flat surface such as a table or cart top Dimensions and Weight Width 45 8 cm 18 in Depth 50 8 cm 20 in Height 25 5 cm 10 in Weight 13 6 kg 30 Ibs 9 2 ForceTriad User s Guide Performance Characteristics Operating Parameters Ambient temperature range Relative humidity Atmospheric pressure Warm up time Transport and Storage Ambient temperature range Relative humidity Atmospheric pressure Duration of storage Internal Memory Nonvolatile battery backed RAM Storage capacity 10 C to 402 C 30 to 75 non condensing 700 millibars to 1060 millibars If transported or stored at temperatures outside the operating temperature range allow one hour for the energy platform to reach room temperature before use 30 to 65 0 to 9096 non condensing 500 millibars to 1060 millibars The ForceTriad energy platform may be stored indefinitely If the energy platform is stored for over one year the memory battery must be replaced Battery type Lithium Battery life 120 mAh 256 KB ForceTriad User s Guide eoiuuo9 Performance Characteristics Activation Tone The audio levels stated below are for activation tones cut Valleylab coag bipolar and LigaSure modes and alarm tones REM and system alarms at a distance of one meter Volume adjustable 45 to 65 dBA Frequency Cut 660 Hz Valleylab 800 Hz Coag 940 H
92. yes pue Uoled General Provide as much distance as possible between the energy platform and other electronic equipment such as monitors Do not cross or bundle electronic device cords This energy platform may cause interference with other electronic equipment Active instruments Read the instructions warnings and cautions provided with electrosurgical instruments before using Specific instructions for electrosurgical instruments are not included in this manual Inspect instruments and cords for breaks cracks nicks and other damage before every use If damaged do not use Damaged instruments or cords may result in injury or electrical shock to the patient or surgical team Use only instruments that can withstand the maximum output peak voltage for each output mode as listed in the Technical Specifications chapter in this manual Using an instrument with a voltage rating 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 maximum output voltages in the ForceTriad energy platform and are thus fully compatible Information on voltage ratings for non Valleylab instruments should be obtained from the instrument s manufacturer Pacemakers and ICDs Use electrosurgery and tissue fusion with caution in the presence of internal or external pacemakers I
93. z Bipolar 940 Hz LigaSure 440 Hz Duration Continuous while the system is activated Alarm Tone Volume not adjustable gt 65 dBA Freguency 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 second tones separated by 1 2 second for each REM event Reactivate Regrasp Four 175 msec tones high low high low separated by 1 2 second Check Instrument Six 175 msec tones high low high low high low Seal Complete Two 175 msec tones separated by 175 msec for each Seal Complete event Error System Alert Two 1 2 second tones separated by 1 2 second for each Error System Alert event 9 4 ForceTriad User s Guide Performance Characteristics REM Contact Quality Monitor Interrogation frequency 80 kHz 10 kHz Interrogation current 100 Interrogation voltage 12V RMS Acceptable Resistance Range REM resistance measurements are 10 during RF activation and 5 when RF output is not activated REM patient return electrode 5 to 135 ohms or up to a 4096 increase in the initial measured contact resistance whichever 15 less If the measured resistance is outside the acceptable range s noted above REM fault condition occurs REM Alarm Activation REM patient return electrode When the measured resistance exceeds the standard range of safe resistance below 5 ohms or above 135 ohms or when the i

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