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Force FX™-C Electrosurgical Generator

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1. 9 9 Electromagnetic Compatibility IEC 60601 1 2 IEC 60601 2 2 u 9 9 Voltage Transients Emergency Generator Mains Transfer eene 9 9 Output GCharacteristi s rene cet pectet ee ca ER qe hrec 9 10 Maximum Output for Bipolar and Monopolar Modes u u uu uu u 9 10 Maximum Output for Ultrasonic Electrosurgery u uuu 9 10 Available Power Settings in Watts I u u u u u u u uu u uu uu uuu uuu 9 11 O tDput EWSUc 9 13 Force FX C User s Guide Kalleylab Force FX C User s Guide Introducing the Force FX C Electrosurgical Generator This chapter includes information about Instant Response Technology Bipolar modes Monopolar cut and coag modes Simultaneous coag REM Contact Quality Monitoring System Ultrasonic electrosurgery Read all warnings cautions and instructions provided with this generator before using Read the instructions warnings and cautions provided with electrosurgical accessories before using Specific instructions are not included in this manual Force FX C User s Guide 1 1 Instant Response Technology The Valleylab Force FX C Electrosurgical Generator is an isolated output electrosurgical genera
2. pawaspa A A 5 7 Non REM Patient Return Electrode Alarm 5 7 viii Force User s Guide Chapter 6 After Surgery Preparing the Generator for Reuse I u uuu uuu uuu J TQ 6 2 Storing the G neralor L 6 2 Chapter 7 Troubleshooting General Troubleshooting Guidelines I u u uuu u uuu u 7 2 Correcting a REM Alarm Condition 7 2 Applying Additional Patient Return Electrodes 7 3 GOrreCting eR REP 7 5 Responding to System Alarms eee araea aeaaea aia arne aair ttam enata th insta aaaea amata 7 9 Chapter 8 Maintenance and Repair Responsibility of the Manufacturer 8 2 xe os w erst ente eoe A awu au S dcr Du 8 2 Returning the Generator for Service U u u uu uuu uuu L 8 3 Valleylab Service Center P 8 4 Chapter 9 Technical Specifications Performance Characteristics I e 9 2 DIMENSIONS and Weight k a wD nde el ua 9 2 Operating
3. Bipolar surgery requires lower power because the amount of tissue included in the electrosurgical circuit is limited to the tissue that is grasped by the bipolar instrument Force User s Guide Selecting the Power Setting Typical Power Settings Use the following list of typical power settings for various surgical procedures as a general guideline The Force FX C Electrosurgical Generator cuts effectively at power settings lower than previous models offered by Valleylab If the proper setting is not known set the generator at a very low setting and cautiously increase the power until the desired effect is achieved Power Surgical Procedure Low Power lt 30 watts Dermatology Laparoscopic sterilization both bipolar and monopolar Neurosurgery both bipolar and monopolar Oral surgery Plastic surgery Vasectomies Medium Power Cut 30 100 watts Coag 30 70 watts High Power Cut gt 100 watts Coag gt 70 watts General surgery Head and neck surgery ENT Laparotomy Orthopedic surgery major Polypectomy Thoracic surgery routine Vascular surgery major Ablative cancer surgery mastectomies etc cut 180 300 watts coag 70 120 watts Thoracotomy heavy fulguration 70 120 watts Transurethral resections cut 100 170 watts coag 70 120 watts depending on the thickness of the resection loop and the technique Force FX C User s Guide KieBung Buung A
4. Palleylab User s Guide Force FX C Electrosurgical Generator with Instant Response Technology e This manual and the equipment it describes 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 Force FX C Electrosurgical Generator only Additional technical information is available in the Force FX C Electrosurgical Generator Service Manual Federal USA law restricts this device to sale by or on the order of a physician Equipment covered in this manual Valleylab Force FX C Electrosurgical Generator with Instant Response Technology 110 V Nominal 230 V Nominal auto selected Valleylab Part Number 1023200 Effective Date September 2009 Patent information Protected by U S Pat Nos 5 190 517 5 599 344 and 5 628 745 Trademark acknowledgments Valleylab ForceTriad Force EZ Force Argon LigaSure LigaSmart Smart Cool tip TissueFect REM RFG 3C OptiMumm SurgiStat EDGE AccuVac PolyHesive and Instant Response are trademarks of Valleylab CUSA CUSA EXcel and CEM are trademarks of Integra LifeSciences Corporation or its subsidiary Manufactured by Valleylab a division of Tyco Healthcare Group LP Boulder Colorado 80301 3299 USA Printed in USA
5. Pin 5 isolated ground reference for transmit and receive RF Activation Port The RF activation port is a subminiature telephone jack attached to the contacts of a small relay The contacts are closed when the output is energized and open at all other times This port provides a means to tell other equipment that RF current is being generated This may be useful when making EEG or ECG measurements Expansion Port The 15 pin connector supports the following signals Pin 2 isolated transmit serial data output transmit line Pin isolated receive serial data input receive line Pin 5 isolated ground reference for transmit and receive Pin9 RF disable input signal which when activated by an external device disables active RF output Pin 10 RF current output signal proportional to active RF current Pin 11 RF voltage output signal proportional to active RF voltage Expansion power from the low voltage power supply 5 V pin 6 12 V pin 14 12 V pin 15 and ground pins 12 amp 13 Force FX C User s Guide suoneouioeds eoiuuo9 Performance Characteristics Low Frequency 50 60 Hz Leakage Current Enclosure source lt 300 uA current ground open Source current patient Normal polarity intact ground lt 10 pA leads all outputs Normal polarity ground open lt 50 pA Reverse polarity ground open lt 50 pA Sink current at high lt 50 pA line a
6. Generator Setting 9 36 Force FX C User s Guide Output Characteristics Spray Coag Mode Output power vs impedance 80 Spray coag 60W mode 70 60 50 40 30 Output Power watts 20 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms 160 Output power vs impedance Spray coag 120W mode 140 120 100 80 60 Output Power watts 40 20 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms Force FX C User s Guide 9 37 suoneouioeds eoiuuo9 Output Characteristics 6000 Output power vs peak voltage Spray coag mode 5000 syo uno uedo Output Power watts NH Se NIIS spem 1ndino Output power vs generator settings Spray coag mode Generator Setting Force FX C User s Guide 9 38
7. 300 Output power vs generator settings Pure cut mode Output Power watts Generator Setting 9 24 Force FX C User s Guide Output Characteristics Output power vs impedance for Blend cut 100W mode Output power vs impedance for Blend cut 200W mode Blend Cut Mode Output Power watts Output Power watts 200 180 160 140 120 100 80 60 40 20 400 350 300 250 200 150 100 50 50 100 300 500 700 900 Load Resistance ohms 1200 1600 2000 50 100 300 500 700 900 Load Resistance ohms 1200 1600 2000 Force FX C User s Guide 9 25 suoneouioeds eoiuuo9 Output Characteristics Open circuit peak voltage vs output power for Blend cut mode 1400 _ 1000 800 600 400 Open Circuit Peak Voltage volts 200 Output power vs generator settings Blend cut mode Output Power watts NBN E _ NENNEN _ PTT TT Lt Generator Setting 9 26 Force FX C User s Guide Output Characteristics Monopolar Coag Graphs These measurements were taken using short lt 0 5 meter leads Desiccate 1 Coag Mode 80 Output power vs impedance for Desiccate 1 coag 60W mode 70 60 50 40 30 Output Power watts 20 10 50 100 300 500 700 900 1200 1600 2000 Load Resistnce ohms Output power
8. For details about the output characteristics refer to Chapter 9 Output Characteristics Force FX C User s Guide 10 219U99 3 9 X4 99104 y REM Contact Quality Monitoring System Simultaneous Coag When you simultaneously activate two monopolar instruments for coag output each receives a percentage of the power setting set for the selected mode The amount of power each instrument receives depends on the tissue resistance sensed by the generator at each surgical site Generally the site with lower resistance receives proportionately more power The combined total output power does not exceed the coag power setting You can also use a CUSA handpiece with a CEM nosecone for simultaneous coag when you connect a monopolar instrument to the Monopolar 2 Instrument receptacle Only Desiccate coag is available the maximum power is 70 watts REM Contact Quality Monitoring System 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 generator 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 the return electrode site The Force FX C generator uses the Valleylab REM Contact Quality Monitoring System to monitor the quality of electrical contact between
9. To reduce cross coupling do not twist bundle or clamp cords together Checking the Patient Return Electrode To avoid patient burns ensure that the patient return electrode firmly contacts the skin Always check the patient return electrode periodically and after the patient is repositioned and during procedures involving long periods of activation If a higher than expected power setting seems required or if the patient is repositioned check the patient return electrode for secure placement and check all connecting cables for continuity Changing the Mode Verify the selected mode with the surgeon You cannot change the mode while the generator is activated To change the mode press the desired bipolar cut or coag mode button The indicator above that button illuminates green You can activate only one mode at a time When you change modes within a function bipolar cut coag the power setting remains the same unless it exceeds the maximum for the new mode In that case it reverts to the maximum for the new mode For example if you set the power to 250 watts for Pure cut when you select Blend the power setting changes to 200 watts the maximum for Blend If however you set the power to 65 watts in Desiccate when you select Fulgurate the power setting does not change because it falls within that mode s range 5 2 Force User s Guide Selecting the Power Setting Selecting the Power Setting Confir
10. reappears record the number and call the Valleylab Service Center Contact your Biomedical Engineering Department Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center Contact your Biomedical Engineering Department Do not attempt to use the generator Record the number and call the Valleylab Service Center Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center Contact your Biomedical Engineering Department Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center Do not attempt to use the generator Record the number and call the Valleylab Service Center Contact your Biomedical Engineering Department Force FX C User s Guide 7 9 Responding to System Alarms Number Description Recommended Action 100 105 Software malfunction Turn off then turn on the generator If the alarm number 110 119 reappears record the number and call the Valleylab Service Center 120 Calibration malfunction Contact your Biomedical Engineering Department 121 Software malfunction Turn off then turn on the generator If the alarm number reappears record the number
11. 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 generator completes the self test as described in Chapter 4 Setting Up the Generator Situation Possible Cause Solution Abnormal neuromuscular 1 Metal to metal sparking Check all connections to the stimulation stop surgery generator patient return immediately electrode and active electrodes 2 Can occur during coag Use a lower power setting for the Fulgurate and the Spray modes or select the Desiccate mode 3 Abnormal 50 60 Hz leakage Refer to your Biomedical currents Engineering Department or contact a Valleylab Representative for assistance Generator does not respond when 1 Disconnected power cord or faulty Check power cord connections turned on wall outlet generator and wall outlet Connect the power cord to a functional outlet 2 Faulty power cord Replace the power cord 3 Fuse drawer is open or fuses are Close the fuse drawer Replace blown the blown fuse s Refer to the Force FX C Electrosurgical Generator Service Manual 4 Internal component malfunction Use a backup generator Refer to your Biomedical Engineering Department or contact a Valleylab Representative for assistance Generator is on but did not 1 Software malfunction Turn off then turn on the complete
12. 12 Force User s Guide Output Characteristics Output Waveforms Instant Response Technology an automatic adjustment controls all bipolar modes and all cut modes It does not control the coag modes because of their fulguration capabilities As tissue resistance increases from zero the generator 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 Precise Standard Macro Monopolar Cut Low Pure Blend Monopolar Coag Desiccate Fulgurate LCF Fulgurate Spray 470 kHz sinusoid 470 kHz sinusoid 470 kHz sinusoid 390 kHz sinusoid Similar to the Pure cut mode except the maximum voltage is limited to a lower value 390 kHz sinusoid 390 kHz bursts of sinusoid recurring at 27 kHz intervals 50 duty cycle 240 kHz sinusoid repeated at 39 kHz 8 duty cycle 390 kHz damped sinusoidal bursts with a repetition frequency of 30 kHz into 500 ohms 390 kHz damped sinusoidal bursts with a repetition frequency of 57 kHz into 500 ohms 390 kHz damped sinusoidal bursts with a randomized repetition centered at 28 kHz Frequencies include 21 kHz f 35 kHz Output is further modulated by a random 250 Hz envelope with a variable duty cycle Force FX C User s Guide 9 13 suoneouioeds Output Characteristics Output Power vs
13. 200 using CUSA System 200 optional mounting brackets a Force GSU unit a Force Argon unit or any stable flat surface Dimensions and Weight Width 35 6 cm 14 in Depth 45 7 cm 18 in Height 11 1 4 3 8 in Weight 8 2 kg lt 18 lbs Operating Parameters Ambient temperature 10 to 409 C 50910 104 F range Relative humidity 30 to 75 noncondensing Atmospheric pressure 700 to 1060 millibars Warm up time If transported or stored at temperatures outside the operating temperature range allow one hour for the generator to reach room temperature before use Force FX C User s Guide Performance Characteristics Transport and Storage Ambient temperature 40 to 70 C 40 to 158 F range Relative humidity 25 to 85 noncondensing Atmospheric pressure 500 to 1060 millibars Duration of storage If stored longer than one year the battery must be replaced and a full checkout including calibration must be completed before use For instructions refer to the Force FX C Electrosurgical Generator Service Manual Duty Cycle Under maximum power settings and rated load conditions Pure cut 300 watt setting 300 ohm load the generator is suitable for activation times of 10 seconds on 30 seconds off for 1 hour If the internal temperature of the generator is too high an alarm tone sounds and a number 451 flashes in the Cut display alternately with the power settings You can activate
14. 2009 Valleylab All rights reserved European representative Tyco Healthcare UK Ltd Gosport PO13 OAS UK For information call 1 303 530 2300 Internet address http www valleylab com Force FX C User s Guide Conventions Used in this Guide Indicates a potentially hazardous situation 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 gt important Indicates an operating tip or Notice maintenance suggestion Indicates a hazard which may result in product damage Force FX C 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 whi
15. A 3 8 SUCTION GOAQUIALOMS P 3 9 Contact with Metal Objects 3 9 Active ACCESSOMES III 3 9 Patient Return Electrodes uu a aaah 3 10 Procedures esuo ii SS a 3 11 After Surge 3 12 Chapter 4 Before Surgery QUICK SETUP INSTRUCTIONS 4 2 Setting Up the Generate tied 4 3 Preparing for Bipolar or Macrobipolar Surgery I u uu u uuu 4 5 Connections for Bipolar or Macrobipolar Surgery I u uuu uuu 4 5 Setting Bipolar OU Ui S 4 6 Preparing for MonopolarSUrgery uu 4 7 Connections for Monopolar Surgery u u uu uuuuuuuuuuuu u 4 7 Applying a Patient Return Electrode to the Patient uuu nnne 4 9 Using Two Generators Simultaneously uuu uuu uuu 4 10 k 4 10
16. Note the number and refer to Responding to System Alarms in this chapter In case of a REM alarm refer to Correcting a REM Alarm Condition in this chapter Use a backup generator Contact your Biomedical Engineering Department or a Valleylab Representative for assistance 7 6 Force User s Guide Correcting Malfunctions Situation Possible Cause Solution Continuous monitor interference 1 Faulty chassis to ground Check and correct the chassis connections ground connections for the monitor and for the generator Check other electrical equipment in the room for defective grounds 2 Electrical equipment is grounded Plug all electrical equipment into to different objects rather than a line power at the same location common ground The generator Contact your Biomedical may respond to the resulting Engineering Department or a voltage differences between Valleylab Representative for grounded objects assistance 3 Malfunctioning monitor Replace the monitor Interference with other devices 1 Metal to metal sparking High Check all connections to the only when the generator is settings used for fulguration generator patient return activated electrode and accessories 2 High settings used for fulguration Use lower power settings for fulguration or select the Desiccate mode 3 Electrically inconsistent ground Verify that all ground wires are as wires in the operating room short as possible and
17. Parameters Eddie ak n OR Race ERR drea ren dcn 9 2 Transpertz anid Storage cC 9 3 DU ty CY CIS E E AE 9 3 ntermal uy a aw 9 3 9 4 REM Contact Qualy MO 9 4 neue 9 5 RF Activation 9 5 EXPANSION 9 5 Low Frequency 50 60 Hz Leakage Current uuu uuu 9 6 High Frequency RF Leakage Current u 9 6 u E apaq as 9 7 Power Cord Specification 9 7 Standards and IEC Classifications u 9 8 Class Equipment IEC 60601 1 9 8 Type CF Equipment 60601 1 Defibrillator Proof uuu 9 8 Liquid Spillage IEC 60601 2 2 Clause 44 3 9 9 Electromagnetic Interferenoe
18. REM Alarm Indicator REM Alarm This indicator illuminates red until you properly apply a REM patient return electrode to the patient and connect it to the generator Then the indicator illuminates green When you connect an electrode without the REM safety feature the indicator does not illuminate If the REM system senses an alarm condition the indicator flashes red until you correct the alarm condition then the indicator illuminates green If you are using a return electrode without the REM safety feature the red indicator light is extinguished when you correct the alarm condition Force FX C User s Guide pue SJOJEOIPU 5 Rear Panel Line fuse locator Power entry module Volume control x MONOPOLAR 2 MONOPOLAR 1 BIPOLAR FOOTSWITCH FOOTSWITCH FOOTSWITCH Warning Risk of Fire Replace Fuse as Marked 250V F8 0A 100 120 250V T4 0A 220 240 U S Patents 5 628 745 5 599 344 5 190 517 EN AJ re Monopolar Footswitch Option panel Bipolar Footswitch receptacles receptacle Equipotential grounding lug Use to connect the generator to earth ground 2 8 Force User s Guide Footswitch Receptacles Footswitch Receptacles The rear panel contains three footswitch receptacles two for monopolar and one for bipolar Monopolar Footswit
19. Resistance Graphs The graphs that follow depict the changes for each mode at specific power Output power vs impedance for Precise bipolar 35W mode settings Note These curves represent the lower and upper limits of output power with tolerance included The normal output power will be halfway between these two curves Bipolar Graphs The insulating surface described in IEC 60601 2 2 was used to obtain the bipolar output measurements Precise Bipolar Mode Output Power watts 50 45 40 35 30 25 20 15 10 5 0 10 30 50 70 90 200 400 475 495 515 600 800 1000 Load Resistance ohms 9 14 Force FX C User s Guide Output Characteristics Output power vs impedance for Precise bipolar 70W mode Open circuit peak voltage vs output power for Precise bipolar mode Output Power watts Upen vIrCUIL reak vonage vos 90 80 70 60 50 40 30 20 10 200 180 160 f 10 30 50 70 90 200 400 475 495 515 600 800 1000 Load Resistance ohms 80 60 40 20 140 lt 1 10 20 30 40 50 60 Output Power watts Force FX C User s Guide suoneouioeds eoiuuo9 Output Characteristics Output power vs generator settings Precise bipolar mode 2 T D a 5 Q 5 Generator Setting Standard Bipolar Mode 50 Output power vs impedance Standard bipolar 35W mode 45 40 35 D 30 S 25 D 2
20. and call the Valleylab Service Center 122 Calibration malfunction Contact your Biomedical Engineering Department 123 126 Microcontroller malfunction 130 134 Software malfunction Turn off then turn on the generator If the alarm number 136 138 reappears record the number and call the Valleylab 150 Service Center 151 Microcontroller malfunction Contact your Biomedical Engineering Department 152 Software malfunction Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center 154 Microcontroller malfunction Contact your Biomedical Engineering Department 160 Internal component malfunction Do not attempt to use the generator Record the number and call the Valleylab Service Center 161 163 166 Dosage error Contact your Biomedical Engineering Department 170 173 Microcontroller malfunction 174 Software malfunction Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center 180 185 Internal diagnostics Contact your Biomedical Engineering Department 189 Software malfunction Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center 7 10 Force FX C User s Guide Responding to System Alarms Number Description 190 Bipolar up arrow bipolar down arrow and or a bipolar mode button Precise Standard Macro may be stuck 191 Cut up a
21. by using a surgical smoke evacuator or other means Inadvertent Radio Frequency 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 battery operated 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 Do not use needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may result In some circumstances 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 grounded ground referenced and isolated output generators 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 when positioni
22. contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activations of ICDs To avoid interference with pacemakers place the patient return electrode as close as possible to the site of surgery Make sure the path the current follows from the site of surgery to the return electrode does not pass through the vicinity of the heart or the site where the pacemaker is implanted 4 10 Force User s Guide Preparing for Monopolar Surgery Selecting Cut and Coag Modes Set power levels to the lowest setting before testing an accessory 1 Optional To display the previous settings press the Recall button 2 To select a cut mode press the Low Pure or Blend button The corresponding indicator illuminates green 3 To increase the power for the cut mode you selected press the yellow up arrow A button To decrease the power press the yellow down arrow V button The maximum power setting for Low and Pure is 300 watts The maximum power setting for Blend is 200 watts 4 To select a coag mode press the Low Desiccate Med Fulgurate or High Spray button The corresponding indicator illuminates green To select the LCF fulgurate mode press the Med button and hold for two seconds A tone sounds and an L appears on the left side of the display To return to the standard fulgurate mode press the Med button and hold for two secon
23. determined by Underwriters Laboratories Inc Notice The Force FX C requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Force FX C Service Manual Portable and mobile RF communications equipment can affect the Force FX C Refer to the EMC information provided in the Force FX C Service Manual Voltage Transients Emergency Generator Mains Transfer The Force FX C generator operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source Force FX C User s Guide suoneouioeds eoiuuo9 Output Characteristics Output Characteristics Maximum Output for Bipolar and Monopolar Modes Power readouts agree with actual power into rated load to within 15 or 5 watts whichever is greater Mode Open Circuit Rated Load Power Crest Factor Voltage max max max Bipolar Precise 450 V 100 Q 70W 1 5 Standard 320 V 100 Q 70W 1 5 Macro 750 V 100 Q 70 W 1 5 Monopolar Cut Low 1350 V 300 Q 300 W 1 5 Pure 2300 V 300 Q 300 W 1 5 Blend 3300 V 300 Q 200 W 2 5 Monopolar Coag Desiccate 3500 V 500 Q 120 W 5 Fulgurate 8500 V 500 Q 120 W 7 0 LCF Fulgurate 6900 V 500 Q 120 W 5 5 Spray 9000 V 500 Q 120 W 8 Maximum Output for Ultrasonic Electrosurgery Mode Open Circuit Rated Load Power Crest Factor Voltage max max max Monopolar Cut Low 1000 V 300 Q 100 W 1 5 Mo
24. generator stops functioning even though it is receiving power from a wall outlet Refer to the service manual for instructions 8 2 Force User s Guide Returning the Generator for Service Returning the Generator for Service Before you return the generator call your Valleylab Representative for assistance If you are instructed to send the generator to Valleylab first obtain a Return Authorization Number Then clean the generator and ship it to Valleylab for service Step 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 Hospital clinic name customer number Telephone number Department address city state and zip code Model number Serial number Description of the problem Type of repair to be done Step 2 Clean the Generator Electric Shock Hazard Always turn off and unplug the generator before cleaning Notice Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator A Turn off the generator and unplug the power cord from the wall outlet B Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth Follow the procedures approved by your institution or use a va
25. information when use of electrosurgical appliances is planned in patients with cardiac pacemakers Internal Cardiac Defibrillator ICD activation ICD is activated by electrosurgical generator Stop the procedure and contact the ICD manufacturer for instructions 7 8 Force User s Guide Responding to System Alarms Responding to System Alarms When a system alarm condition exists an alarm tone sounds and a number flashes in the Cut display The generator is disabled until the condition is cleared Most system alarms require some action on your part to correct the condition however some are corrected automatically Use the following table to determine how to correct an alarm condition After correcting the alarm condition verify that the generator completes the self test as described in Chapter 4 Setting Up the Generator Number Description 0 7 Microcontroller malfunction 10 Software malfunction 11 Microcontroller malfunction 12 Software malfunction 13 14 Diagnostic microcontroller 16 malfunction 17 18 Internal component malfunction 19 Internal component malfunction 30 32 Software malfunction 40 60 66 67 Internal diagnostics 68 Microcontroller malfunction 69 71 Software malfunction 80 81 Internal component malfunction 90 Microcontroller malfunction 95 Recommended Action Contact your Biomedical Engineering Department Turn off then turn on the generator If the alarm number
26. setting required to produce the desired surgical effect varies depending on the surgeon s technique the selected mode and the size of the active electrode Low power settings reduce the amount of current delivered to the patient minimize the demand on the patient return electrode and help protect the patient and surgical team from accidental burns and shocks The following are techniques for keeping power settings low Concentrating the current by using a small active electrode The smaller the active electrode the higher the current density it delivers to tissue and the less power it requires to produce the same surgical effect For example a needle electrode cuts at a lower power setting than a blade electrode A small ball electrode desiccates or fulgurates tissue at a lower power setting than a large ball electrode Coagulating tissue by using fulguration rather than desiccation Because fulguration sparks to a wider area of tissue surface coagulation can be achieved with a lower power setting using Fulgurate rather than Desiccate Cutting by sparking rather than by desiccating tissue Cut produces continuous sparks that cut cleanly and quickly when the active electrode is held just above the tissue and kept in motion Placing the active electrode in contact with the tissue produces desiccation that increases tissue resistance A higher power setting may be required to overcome the increased resistance Using bipolar surgery
27. the generator and change the power settings while this condition exists Internal Memory Nonvolatile battery Battery type 3 V lithium button cell backed RAM Storage capacity Battery life 5 years One configuration including three power settings and three mode settings The last twenty error codes detected by the generator The number of times and length of activation for each mode The average power setting used for each mode The total time the generator is on Other service related information Force FX C User s Guide eoiuuo9 Performance Characteristics Audio Volume The audio levels stated below are for activation tones bipolar cut and coag and alarm tones REM and system alarms at a distance of one meter Alarm tones meet the requirements for IEC 601 2 2 Activation Tone Volume adjustable 45 to gt 65 dB Frequency Bipolar 940 Hz Cut 660 Hz Coag 940 Hz Duration Continuous while the generator is activated Alarm Tone Volume not gt 65 dB adjustable Frequency 660 Hz Duration 250 to 500 ms REM Contact Quality Monitor REM current is measured according to IEC 601 1 Ed 1988 Figure 15 Measurement 80 kHz 10 kHz frequency Measurement current lt 10 pA 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 40 increa
28. the self test generator 2 Internal component malfunction Use a backup generator Refer to your Biomedical Engineering Department or contact a Valleylab Representative for assistance Force FX C User s Guide 7 5 Correcting Malfunctions Situation Possible Cause Solution Generator is on and accessory is activated but generator does not deliver output 1 Malfunctioning footswitch or handswitching instrument Incompatible footswitch Footswitch connected to Monopolar 1 Footswitch receptacle is being used for surgical instrument in Monopolar 2 receptacle Footswitch connected to Monopolar 2 Footswitch receptacle is being used for instrument connected to Monopolar 1 CEM receptacle Power set too low An alarm condition exists Internal component malfunction Turn off the generator Check and correct all accessory connections Turn on the generator Replace the accessory if it continues to malfunction Use only a Valleylab footswitch with the Force FX C generator Connect the footswitch to the Monopolar 2 Footswitch receptacle or Connect the instrument to the Monopolar 1 CEM receptacle Connect the footswitch to the Monopolar 1 Footswitch receptacle or Connect the instrument to the Monopolar 2 receptacle Increase the power setting Refer to Chapter 5 Changing the Power Setting Check the Cut display for an alarm number
29. up Press A to increase the power V Press V to decrease the power PURE BLEND Low mode button Select for a cut with little or no sparking Blend mode button Select for slower cutting and additional hemostasis Pure mode button Select for an even cut with little or no hemostasis This is the default monopolar cut mode Force User s Guide 2 5 pue SJOJEOIPU S OJJUOO Monopolar Coag Controls Monopolar Coag Controls Coag indicator Coag display When you activate coag this Shows the power setting indicator illuminates blue and in watts for the selected an activation tone sounds mode Mode indicators green when you press the corresponding mode button Power buttons Press to increase the power vr Press V to decrease the power Desiccate Fulgurate Spray Spray mode button Select to evenly coagulate a wide area of tissue with a spray of sparks penetration is less deep and tissue area is larger than in fulgurate mode Desiccate mode button Select to desiccate the area of tissue that is in direct contact with the active electrode Fulgurate mode button Select to fulgurate an area of tissue with a spray of sparks This unit is equipped with an additional fulgurate mode which incorporates a lower crest factor LCF than the factory default fulgurate mode Details about this addi
30. use The instrument receptacles on this generator 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 accessories before using Specific instructions are not included in this manual Inspect accessories and cords especially reusable accessories and cords for breaks cracks nicks or 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 Force FX C User s Guide 4 7 eJojeg Preparing Monopolar Surgery Figure 4 3 Connection for monopolar surgery using footswitch activation and a footswitching or handswitching instrument using Monopolar 1 Footswitch receptacle and Monopolar 1 CEM Instrument receptacle Footswitching or handswitching instrument Figure 4 4 Connection for monopolar surgery using footswitch activation and a footswitching or handswitching instrument using Monopolar 2 Footswitch receptacle and Monopolar 2 Instrument receptacle MONOPOLAR 1 FOOTSWITCH Valleylab monopolar footswitch Patient return electrode MONOPOLAR 2 FOOTSWITCH Footswitching or handswitching instrument Valleylab monopolar footswitch Patient r
31. vs impedance for 160 Desiccate 1 coag 120W mode 140 120 100 80 60 Output Power watts 40 20 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms Force FX C User s Guide 9 27 eoiuuo9 Output Characteristics Open circuit peak voltage vs output power for Desiccate 1 coag mode Output power vs generator settings Desiccate 1 coag mode Open Circuit Peak Voltage volts Output Power watts 2500 2000 1500 1000 500 40 50 60 70 Generator Setting 9 28 Force FX C User s Guide Output Characteristics Desiccate 2 Coag Mode Output power vs impedance for 80 Desiccate 2 coag 60W mode 70 60 T 5 50 2 40 a 5 30 g 2 O 10 0 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms 160 Output power vs impedance for Desiccate 2 coag 120W mode 140 120 100 80 60 Output Power watts 40 20 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms Force FX C User s Guide 9 29 suoneouioeds eoiuuo9 Output Characteristics 600 110 120 100 80 70 50 60 Output Power watts 8 N 8 8 8 8 8 xeeg HNO uedo sem jewog 1ndino output power for Desiccate 2 settings Desiccate 2 coag mode coag mode Output power vs generator Open circuit peak voltage vs 9 30 Generat
32. 0 15 2 10 5 5 0 10 30 50 70 90 200 400 475 495 515 600 800 1000 Load Resistance ohms 9 16 Force FX C User s Guide Output Characteristics Output power vs impedance for Standard bipolar 70W mode 50 45 40 35 4 30 t 25 20 2 15 10 5 0 10 30 50 70 90 200 400 475 495 515 600 800 1000 Load Resistance ohms Note In the Bipolar Standard mode only the power curve will reflect both High and Low output values between the impedance range of 475 600 ohms This is based on the sensed impedance value the generator calculates and the tolerances of the sensing circuits This is a function of the generator as the software is designed to reduce switch to Low output the output power when the impedance exceeds a reference 475 600 ohms impedance level Clinically above 475 ohms the tissue is almost completely desiccated By dropping to lower output power levels we allow the surgeon sufficient time to deactivate the output before tissue sticking occurs Force FX C User s Guide suoneouioeds Output Characteristics Open circuit peak voltage vs output power for Standard bipolar mode Open circuit peak voltage vs output power for Standard bipolar mode Open Circuit Peak Voltage volts Output Power watts 160 140 120 100 80 60 40 20 20 30 40 50 60 70 Out
33. 700 900 1200 1600 2000 Load Resistance ohms Force FX C User s Guide 9 21 suoneouioeds eoiuuo9 Output Characteristics 700 Open circuit peak voltage vs output power for Low cut mode 600 2 o o 20 jj 5 400 4 NC oO D 300 2 O 9 M ar tr 82885 28388 c c amp c Q ON ON Output Power watts 300 Output power vs generator settings Low cut mode 250 200 150 100 Output Power watts 50 Generator Setting 9 22 Force FX C User s Guide Output Characteristics Output power vs impedance for Pure cut 150W mode Output power vs impedance for Pure cut 300W mode Pure Cut Mode Output Power watts Output Power watts 200 180 160 140 120 100 80 60 40 20 0 400 350 300 250 200 150 100 50 100 300 500 700 900 Load Resistance ohms 1200 1600 2000 50 100 300 500 700 900 Load Resistance ohms 1200 1600 2000 Force FX C User s Guide 9 23 suoneouioeds eoiuuoo Output Characteristics 1200 Open circuit peak voltage vs output power for Pure cut mode gt 1000 o gt 600 gt 400 80 90 00 210 220 230 240 250 260 270 280 290
34. AE NA RANES 2 9 Power Enty y u A EAS 2 9 Activation Tone Volume Control u 2 10 E EE A E A 2 10 Chapter 3 Patient and Operating Room Safety GONG Meal A E E E uD T A T 3 2 Fire EXPlOSIOM m 3 3 Fire Hazard with Oxygen Circuit Connections u uuu 3 3 Electrosurgical SMOKE ierit re odere 3 4 Inadvertent Radio Frequency Burns 3 4 Ensure Proper Connections RS 3 5 ACCOSSONIOS 3 5 SERVICING 3 5 iio DE 3 5 ACTIVE elezione 3 5 Patient Return u y 3 6 Force FX C User s Guide vii GOIGdSs mro TM E ET 3 6 GON zio TP REPERTUS A 3 7 SUrg lyz su IL 3 8 Ie iride 3 8 FOP CGPS NAE
35. Selecting Cut and Coag Modes 4 11 ez Tp ro VI Go a Cm 4 11 Preparing for Ultrasonic Electrosurgery 4 13 Connecting the Patient Return Electrode I uuu uuu 4 13 Connecting the CUSA Handpiece with Nosecone uuu uu u 4 13 Setting the Output POW P 4 14 Sim ltaneous 4 15 Chapter 5 During Surgery Checking Accessory Connections eee N ua Nusa aaa asss saa 5 2 Checking the Patient Return Electrode U U u uuu 5 2 Ghanging the y as Saa Saa aa 5 2 Selecting the Power Settings II chsewastdaetsvoedebenlcesdencadhoveses 5 3 Changing the Power Setting 5 3 Techniques for Keeping Power Settings Low uuu 5 4 Typical OI RT 5 5 Activating the Surgical Instrument I eiiis U uu uuu 5 6 Adjusting the Volume of Activation TONES 1 u uuu uuu 5 7 Responding 10 Alarms 5 7 Sk ua uha
36. Valleylab generator or patient return electrode during these types of surgical procedures the user should seek written guidance from the manufacturer of the active accessory regarding the currents and duty cycles that can be expected as well as detailed user instructions In some instances the application of additional patient return electrodes may help mitigate the increased risk Changing the Power Setting Verify the power settings for the selected mode with the surgeon You can change the power setting when the generator is on including when it is activated To increase the power press the up arrow A button for the selected mode To decrease the power press the down arrow button for the selected mode Force FX C User s Guide 5 3 KieBung Buung Selecting the Power Setting When you press and release the power button the power changes by one setting 1 5 or 10 watts based on the settings available for the selected mode The available power settings are listed in Chapter 9 Technical Specifications To reach the maximum or minimum power setting for the selected mode press and hold the up arrow A or down arrow V button The setting changes slowly at first then more rapidly Release the button when the desired setting is displayed If you try to set the power above the maximum setting or below the minimum setting for the selected mode a tone sounds Techniques for Keeping Power Settings Low The power
37. a Press V to decrease the power C CA Standard Mode indicators Illuminate green when you MACRO press the corresponding mode button Precise mode button Select for fine bipolar tissue desiccation Macro mode button Select for macrobipolar output Standard mode button Select for standard bipolar tissue desiccation This is the default bipolar mode Force FX C User s Guide s op d 5 tJ pue SJOJEOIPU 5 Bipolar Instrument Receptacle Bipolar Instrument Receptacle BIPOLAR Accessories must be connected to the proper receptacle type In particular bipolar accessories must be connected to the Bipolar receptacle only Improper connection may result in inadvertent generator activation or a REM Contact Quality Monitor alarm You can connect either a footswitching or handswitching bipolar instrument to the Bipolar receptacle Connect a footswitching instrument with a two pin connector or Connect a handswitching instrument with a three pin connector 2 4 Force FX C User s Guide Monopolar Cut Controls Monopolar Cut Controls Cut display Shows the power setting in watts for the selected mode Mode indicators CUT Cut indicator When you activate cut this indicator illuminates yellow and an activation tone sounds Power buttons Illuminate green when you press the corresponding mode button l LOW m LM gn dg AJ
38. alized 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 by direct contact with the active electrode or by the active accessory electrode or cable being in close proximity to the conductive object Do not use hybrid trocars that are composed of both metal and plastic components 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 electrosurgical generator is activated for extended periods at high power levels inducing high current levels in the cannula Ensure that the insulation of disposable 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 generator in an open circuit condition To reduce the chances of unintended burns activate the gen
39. ce Refer to this generator s service manual for maintenance recommendations and function and output power verification procedures Before Surgery Active Accessories pue 1 Warning Electric Shock Hazard Do not connect wet accessories to the generator Connect accessories to the proper receptacle Improper connection may result in inadvertent accessory activation or other potentially hazardous conditions Follow the instructions provided with electrosurgical accessories for proper connection and use Electric Shock Hazard Ensure that all accessories and adapters are correctly connected and that no metal is exposed Read the instructions warnings and cautions provided with electrosurgical accessories before using Specific instructions are not included in this manual Force FX C User s Guide 3 5 Accessories must connected to the proper receptacle type In particular bipolar accessories must be connected to the bipolar receptacle only Improper connection of accessories may result in inadvertent generator activation or a REM Contact Quality Monitor alarm Set power levels to the lowest setting before testing an accessory Inspect accessories and cords especially reusable accessories and cords for breaks cracks nicks or other damage before every use If damaged do not use Failure to observe this precaution may result in injury
40. ch Receptacles You must connect a monopolar footswitch if you connect a monopolar footswitching instrument to the generator Use only a Valleylab monopolar footswitch with the Force FX C generator Use of an incompatible footswitch may cause unexpected output TAR Connect a two pedal Valleylab monopolar footswitch to the Monopolar 1 FOOTSWITCH Footswitch receptacle The connected footswitch activates monopolar output for the instrument that is connected to the Monopolar 1 CEM Instrument receptacle on the front panel Connect two pedal monopolar footswitch to the Monopolar 2 Footswitch FOOTSWITCH receptacle The connected footswitch activates monopolar output for the instrument that is connected to the Monopolar 2 Instrument receptacle on the front panel Bipolar Footswitch Receptacle You must connect a bipolar footswitch if you connect a bipolar footswitching instrument to the generator BIPOLAR Connect single pedal bipolar footswitch to the Bipolar Footswitch receptacle The connected footswitch activates bipolar output for the instrument that is connected to the Bipolar Instrument receptacle on the front panel Power Entry Module The power entry module consists of a power cord receptacle and a fuse drawer Fuse drawer The fuse drawer contains two fuses The Force FX C Electrosurgical Generator Service Manual contains instructions for changing the fuses Power cord receptacle F
41. ch 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 Sealing System One year from date of shipment LigaSure Reusable Instruments One 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 aggrega
42. ctivating the Surgical Instrument Activating the Surgical Instrument Bipolar Notice Do not activate the generator until the forceps have made contact with the patient Product damage may occur To activate a handswitching instrument use the controls on the instrument or on the appropriate footswitch To activate a footswitching instrument you must use a footswitch To reduce the possibility of alternate site burns that may be caused by RF leakage currents avoid unnecessary and prolonged activation of the generator If you use bipolar output when a return electrode is applied to the patient the return electrode circuit is deactivated automatically to eliminate the possibility of current dispersal Handswitching Close forceps tines firmly Footswitching Press pedal Activation Indicator Activation tone sounds Bipolar indicator illuminates blue Monopolar CUSA Handpiece with CEM Nosecone Press Cut or Coag button or Close forceps tines firmly Press Cut or Coag button on CEM Nosecone Press Cut or Coag pedal n a Press Cut or Coag pedal Activation tone sounds Cut indicator illuminates yellow or Coag indicator illuminates blue Activation tone sounds Cut indicator illuminates yellow or Coag indicator illuminates blue CEM indicator on front panel illuminates green when handpiece is properly connected to the generator 5 6 Force User s Guide Adjus
43. ctrode Alarm When a non REM patient return electrode is connected and the generator detects a cord fault condition the REM Alarm indicator illuminates red When you correct the alarm condition the indicator is extinguished Force FX C User s Guide KieBung Buung Responding to Alarms System Alarm When the generator senses a system alarm condition an alarm tone sounds and the generator is deactivated An alarm number flashes in the Cut display on the front panel 1 Turn off the generator 2 Turn on the generator and verify that the self test is completed successfully If the alarm number reappears note the number and refer to Chapter 7 Responding to System Alarms If you are unable to correct the system alarm condition use a backup generator to complete the surgical procedure 5 8 Force User s Guide After Surgery This chapter instructs you on Preparing the generator for reuse Storing the generator Force FX C User s Guide 6 1 Preparing the Generator for Reuse Preparing the Generator for Reuse Do not reuse or resterilize accessories labeled disposable or single use only Step 1 Disconnect the accessories A Turn off the generator B If applicable remove the patient return electrode from the patient Disconnect all accessories from the front panel Ifthe accessory is disposable single use only dispose of it according to the procedures for your
44. cturer Responsibility of the Manufacturer Valleylab is responsible for the safety reliability and performance of the generator only under the following circumstances Installation and setup procedures in this manual are followed 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 the Warranty section in this guide Routine Maintenance Notice Refer to the generator service manual for maintenance recommendations and function and output power verification procedures When should the generator be checked or serviced Valleylab recommends that the generator be inspected by qualified service personnel at least twice a year This inspection should include checking the calibration of the generator When should the power cord be checked or replaced Check the power cord each time you use the generator 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 generator fails the self test or if the
45. d the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures Use electrosurgery with caution in the presence of internal or external pacemakers Interference produced by the use of electrosurgical devices can cause devices such as 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 electrosurgical appliances is planned in patients with cardiac pacemakers If the patient has an internal cardiac defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activations of ICDs Valleylab recommends against the use of laparoscopic surgery on pregnant patients Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted in serious unintended patient injury including bowel perforation and unintended irreversible tissue necrosis Hazardous Electrical Output This equipment is for use only by trained licensed physicians Read all warnings cautions and instructions provided with this generator before using 3 2 Force FX C User s Guide Fire Explosion Explosion Hazard Do not use electrosurgery in th
46. ds A tone sounds and the L disappears from the left side of the Coag display 5 To increase the power for the selected coag mode press the blue up arrow A button To decrease the power press the blue down arrow V button The maximum power setting for each coag mode is 120 watts In the LCF fulgurate mode an L appears on the left side of the display When the LCF fulgurate power is set above 95 watts the power setting display alternates between showing the power setting for example 110 watts and L Simultaneous Coag Connect two monopolar instruments for simultaneous coag Each receives a percentage of the overall power setting The amount of power provided to each instrument depends on the tissue resistance sensed by the generator at each surgical site Generally the site with lower resistance receives proportionately more power The combined total output power does not exceed the overall power setting for the coag mode selected Force FX C User s Guide 4 11 eJojeg Preparing Monopolar Surgery Figure 4 6 Connection for simultaneous coag using two handswitching instruments Monopolar instrument or CUSA handpiece with CEM nosecone Patient return electrode Monopolar instrument Figure 4 7 Connection for simultaneous coag using two footswitching instruments Monopolar instrument or CUSA handpiece with CEM nosecone Valleylab Pati
47. e generator 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 3 6 Force FX C User s Guide Generator Patient Safety Use the generator only if the self test has been completed as described Otherwise inaccurate power outputs may result Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters Fire Hazard Do not use extension cords The instrument receptacles on this generator 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 Do not stack equipment on top of the generator or place the generator on top of electrical equipment except a Force GSU unit or a Force Argon unit These configurations are unstable and or do not allow for adequate cooling When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard Provide as much distance as possible between the electrosurgical generator and other electronic equipment such as monitors An activated electrosurgical generator may cause interference with them Do not tur
48. e other two bipolar modes For details about the output characteristics refer to Chapter 9 Output Characteristics Coag Modes Three cut modes low pure and blend allow a wide range of power settings necessary to perform diverse surgical procedures Low may be used for cut with little or no sparking useful for delicate tissue or laparoscopic surgery Pure may be used when you desire a clean precise cut in any tissue with little or no hemostasis Blend may be used where slower cutting and additional hemostasis is desired The three coagulation modes desiccate fulgurate and spray help control the size of the area and the depth of penetration during tissue coagulation Desiccate dehydrates and destroys tissue without sparking or cutting Because the active electrode directly touches the tissue more current reaches the patient Desiccation places the greatest demand on the patient return electrode 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 affords optimum fulguration penetration is less deep and the tissue area is larger than with the fulgurate mode
49. e presence of flammable anesthetics Fire Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room Flammable substances such as alcohol based skin prepping agents and tinctures Naturally occurring flammable gases which may accumulate in body cavities such as the bowel Oxygen enriched atmospheres Oxidizing agents such as nitrous oxide N20 atmospheres The sparking and heating associated with electrosurgery can provide an ignition source Observe fire precautions at all times When using electrosurgery in the same room with any of these substances or gases prevent their accumulation or pooling under surgical drapes or within the area where electrosurgery is performed Fire Hazard with Oxygen Circuit Connections Fire Explosion Hazard Verify that all oxygen circuit connections are leak free before and during the use of electrosurgery Verify that endotracheal tubes are leak free and that the cuff is properly sealed to prevent oxygen leaks Enriched oxygen atmospheres may result in fires and burns to patients or the surgical team Force FX C User s Guide 3 3 pue Electrosurgical Smoke 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
50. ears record the number and call the Valleylab Service Center Contact your Biomedical Engineering Department Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center Force FX C User s Guide 6unoouse qno Number 232 240 242 244 245 246 247 260 261 262 270 271 451 Description Microcontroller malfunction Software malfunction Microcontroller malfunction Internal diagnostics Software malfunction The internal temperature limit was exceeded due to length of activation time Recommended Action Contact your Biomedical Engineering Department Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center Contact your Biomedical Engineering Department Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center Verify that the location of the generator allows for adequate cooling Use the lowest power setting that achieves the desired effect Limit activation times if possible 7 12 Force FX C User s Guide Maintenance and Repair Refer to this chapter for information on The manufacturer s responsibility Routine maintenance Returning the generator for service Service centers Force FX C User s Guide 8 1 Responsibility of the Manufa
51. ectrode that is not in use If the alarm persists go to the next step Force FX C User s Guide Correcting REM Alarm Condition 4 Apply a third patient return electrode a Unplug the second patient return electrode from the generator Do not remove either return electrode from the patient b Apply a third REM electrode to the patient and connect it to the Patient Return Electrode receptacle Select the next best well vascularized convex area close to the surgical site Third REM electrode If the alarm clears leave the generator on during draping to avoid disturbing the return electrode Remove the return electrodes that are not in use If the alarm persists go to the next step 5 Unplug the patient return electrode from the generator Use a Valleylab multiple return s cord adapter 20507 to connect two patient return electrodes to the generator a Insert the adapter into the Patient Return Electrode receptacle Adapter b Insert the plugs of two of the patient return electrodes into the adapter Choose the two return electrodes that are on the most vascularized convex areas in closest proximity to the surgical site If the alarm clears leave the generator on during draping to avoid disturbing the return electrodes Remove the return electrode that is not in use If the REM alarm persists use a backup generator and repeat these steps 7 4 Force FX C User
52. ent return electrode monopolar footswitches Monopolar instrument 4 12 Force FX C User s Guide Preparing for Ultrasonic Electrosurgery Preparing for Ultrasonic Electrosurgery To prepare for ultrasonic electrosurgery first prepare the CUSA System Refer to the CUSA System 200 User s Guide or CUSA EXcel System User s Guide for assembly and setup instructions Assemble and sterilize the CUSA handpiece and the CEM nosecone Connecting the Patient Return Electrode Valleylab recommends using a REM patient return electrode to maximize patient safety For further information refer to Applying a Patient Return Electrode to the Patient in this chapter Connecting the CUSA Handpiece with CEM Nosecone Electric Shock Hazard Do not connect wet accessories to the generator Ensure that all accessories and adapters are correctly connected and that metal is exposed Connect accessories to the proper receptacle Improper connection of accessories may result in inadvertent accessory activation or other potentially hazardous conditions Follow the instructions provided with electrosurgical accessories for proper connection and use Inspect accessories and cords especially reusable accessories and cords for breaks cracks nicks or 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 Force FX C Use
53. erator 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 or desiccate 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 Force FX C User s Guide Ayayes pue After Surgery After Surgery Electric Shock Hazard Always turn off and unplug the generator before cleaning Do not reuse or resterilize accessories labeled disposable or single use only Notice Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator 3 12 Force User s Guide Before Surgery This chapter contains procedures for Preparing the generator for surgery Preparing for bipolar or macrobipolar surgery Preparing for monopolar surgery Preparing for ultrasonic electrosurgery Read all warnings cautions and instructions provided with this generator before using Read the instructions warnings and cautions provided with electrosurgical accessories before using Specific instructions are not included in this manual Force FX C User s Guide 4 1 Quick Setup Instructions Quick Setup I
54. eturn electrode Force FX C User s Guide Preparing Monopolar Surgery Figure 4 5 Connection for monopolar surgery using handswitch activation and a monopolar handswitching instrument using either Monopolar Instrument receptacle Handswitching instrument Patient return electrode Applying a Patient Return Electrode to the Patient Warning The safe use of monopolar electrosurgery requires proper placement of the patient return electrode To avoid electrosurgical burns beneath the patient return electrode follow 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 Using a patient return electrode without the REM safety feature will not activate the Valleylab REM Contact Quality Monitoring System Valleylab recommends using REM patient return electrodes to maximize patient safety Using a patient return electrode without the REM safety feature may result in a patient burn Refer to the manufacturer s instructions for application site and placement procedures When using metal plate patient return electrodes use a conductive gel specifically designed for electrosurgery Force FX C User s Guide eJojeg Preparing Monopolar Surgery Using Two Generators Simultaneously Do not stack equipment on top of the generator or place the gene
55. ffect is achieved Forceps Notice Do not activate the generator until the forceps have made contact with the patient Product damage may occur Force FX C User s Guide During Surgery Suction Coagulators To avoid the possibility of a burn to the surgeon always turn the generator off before bending or reshaping the coagulator suction tube Ensure that the outside of the coagulator suction tube remains free of blood and mucus Failure to clean the coagulator suction tube can allow electrical conductance by means of the contaminants that may result in patient burns Do not immerse the suction coagulator handswitch mechanism in saline solution or other conductive fluids Unintended activation may result Contact with Metal Objects Contact of the active electrode with any metal such as hemostats Gomco clamps Kocher clamps etc will greatly increase current flow and can result in unintended catastrophic burn injury 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
56. g Guidelines General Troubleshooting Guidelines If the Force FX C generator malfunctions check for obvious conditions that may have caused the problem Check the generator for visible signs of physical damage Make sure the fuse drawer is tightly closed Verify that all cords are connected and attached properly If an error code is displayed turn the generator off then on again If the malfunction persists the generator may require service Contact your institution s Biomedical Engineering Department Correcting a REM Alarm Condition To correct a REM alarm condition follow these steps 1 Verify that the patient return electrode cord is correctly connected to the generator 2 Inspect the plug cord and the connection of the cord to the return electrode If you find evidence of excessive wear cracks breaks or other visible damage replace the return electrode and or the cord 3 Verify that the return electrode is in contact with the patient per the package instructions for applying the return electrode 4 If the REM alarm persists If you are using a REM patient return electrode apply another REM electrode Refer to Applying Additional Patient Return Electrodes in this chapter or If you are using a patient return electrode without the REM safety feature apply a new patient return electrode and or use a backup generator to complete the surgical procedure When you correct a REM alarm cond
57. go to the same grounded metal 4 If interference continues when the Ask your Biomedical Engineering generator is activated the monitor is responding to radiated frequencies Department to check with the manufacturer of the monitor Some manufacturers offer RF choke filters for use in monitor leads The filters reduce interference when the generator is activated and minimize the potential for an electrosurgical burn at the site of the monitor electrode Force FX C User s Guide 7 7 Correcting Malfunctions Situation Possible Cause Solution Pacemaker interference 1 Intermittent connections or metal to metal sparking 2 Current traveling from active to return electrode during monopolar electrosurgery is passing too close to pacemaker 1 Check the active and patient return electrode cord connections It may be necessary to reprogram the pacemaker 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 Consult the pacemaker manufacturer or hospital Cardiology Department for further
58. he patient contact area as previously described The REM system can monitor only the pin to pin resistance at the connector and can detect broken wires or connectors in the return electrode cord Ultrasonic Electrosurgery The Force FX C generator works in conjunction with the CUSA System 200 and CUSA EXcel for procedures where combined ultrasonic dissection and electrosurgical cutting and coagulation is desired either simultaneously or independently In addition to convenience the combination of ultrasonic vibration plus simultaneous electrosurgical current prevents charring of the tip and decreases sticking and disruption of coagulum leading to more effective hemostasis When you connect a CUSA handpiece with a CEM nosecone to the generator for ultrasonic electrosurgery it limits the monopolar output power automatically The maximum power you can set for monopolar cut is 100 watts The maximum power you can set for monopolar coag is 70 watts When you activate the handpiece for cut or coag output the Low cut mode or the Desiccate coag mode is in effect automatically The remaining cut modes and coag modes are not available Force FX C User s Guide 10 219U99 1 9 9 X4 99104 y Kalleylab Force FX C User s Guide Controls Indicators and Receptacles This chapter describes the front and rear panels including all controls indicators receptacles the fuse drawer a
59. institution If the accessory is reusable clean and sterilize it according to the manufacturer s instructions C Disconnect and store any footswitch es used Step 2 Clean the generator Electric Shock Hazard Always turn off and unplug the generator before cleaning Notice Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator A Turn off the generator and unplug the power cord from the wall outlet B Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth Follow the procedures approved by your institution or use a validated infection control procedure Do not allow fluids to enter the chassis The generator cannot be sterilized Storing the Generator If the generator is stored at a temperature outside its normal operating range of 10 to 40 C 50 to 104 F allow it to sit at room temperature for one hour prior to use The generator can be stored indefinitely However if you store it longer than one year you must perform specific checkout procedures before use refer to the service manual Force User s Guide Troubleshooting This chapter includes Correcting a REM alarm condition Correcting malfunctions Responding to system alarms Force FX C User s Guide 7 1 General Troubleshootin
60. intain a consistent effect across different tissue density This adjustment is based on the selected mode bipolar or cut modes only the power setting and the level of tissue resistance The maximum output voltage is controlled to reduce capacitive coupling and video interference and to minimize sparking Force User s Guide Bipolar Modes Bipolar Modes Monopolar Cut and Delicate tissue requires less heat to desiccate quickly The Force FX C generator provides low voltage continuous current for faster desiccation without sparking The possibility of sparking increases as desiccated tissue dries and becomes more resistant The generator protects against sparking by limiting the bipolar voltage at relatively high levels of tissue resistance Three bipolar modes are available precise standard and macrobipolar Precise low may be used when a high degree of precision and fine control over the amount of desiccation are essential Voltage is kept low to prevent sparking The power remains constant over a specific range of tissue resistance allowing a consistent tissue effect Standard medium may be used for most bipolar applications Voltage is kept low to prevent sparking The power remains constant over a specific range of tissue resistance allowing a consistent tissue effect Macro macrobipolar may be used for bipolar cutting or rapid coagulation Voltage is higher and there is more power than with th
61. is available the maximum power is limited to 70 watts Refer to Preparing for Monopolar Surgery in this chapter for more information Force FX C User s Guide eJojeg Kalleylab 4 16 Force FX C User s Guide During Surgery This chapter covers the following topics Checking accessory connections Checking the patient return electrode Changing the mode Selecting the power setting Activating the surgical instrument Adjusting the volume of activation tones Responding to alarms Read all warnings cautions and instructions provided with this generator before using Read the instructions warnings and cautions provided with electrosurgical accessories before using Specific instructions are not included in this manual Force FX C User s Guide 5 1 Checking Accessory Connections Checking Accessory Connections Do not wrap the accessory 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 Examine all accessories and connections to the electrosurgical generator before using Ensure that the accessories function as intended Improper connection may result in arcs sparks accessory malfunction or unintended surgical effects Verify that all accessories are properly connected to the generator When multiple accessories are used keep cords separate
62. itch connect it to the Monopolar 1 Footswitch receptacle on the rear panel Apply the patient return electrode to the patient and connect it to the Patient Return Electrode receptacle on the front panel Connect the handpiece to the Monopolar 1 CEM Instrument receptacle on the front panel For simultaneous coag connect a monopolar accessory to the Monopolar 2 Instrument receptacle Verify or change the Low cut or Desiccate coag power settings Force User s Guide Setting Up the Generator Setting Up the Generator Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters Fire Hazard Do not use extension cords Patient Safety Use the generator only if the self test has been completed as described Otherwise inaccurate power outputs may result Do not stack equipment on top of the generator or place the generator on top of electrical equipment except a Force GSU unit or a Force Argon unit These configurations are unstable and or do not allow for adequate cooling Provide as much distance as possible between the electrosurgical generator and other electronic equipment such as monitors An activated electrosurgical generator may cause interference with them Nonfunction of the generator may cause interruption of surgery A backup generator should be available for use Do not turn the activation tone down to an inaudible level The activation t
63. ition the generator is enabled and the REM Alarm indicator changes as described below If you are using a REM patient return electrode the indicator illuminates green If you are using a patient return electrode without the REM safety feature the red indicator light is extinguished 7 2 Force FX C User s Guide Correcting a REM Alarm Condition Applying Additional Patient Return Electrodes If you are using a Valleylab REM patient return electrode follow this procedure to correct a REM alarm condition 1 Inspect the return electrode connector a b Unplug the patient return electrode from the generator Verify that the pin on the plug is present and not bent Carefully reinsert the plug into the Patient Return Electrode receptacle Ensure that the pin enters the hole and that the plug inserts fully If the alarm persists go to the next step Apply firm pressure over the entire surface area of the patient return electrode particularly the center If the alarm persists go to the next step Apply a second patient return electrode a Unplug the patient return electrode from the generator Do not remove it from the patient Apply a second REM electrode to an appropriate site and connect it to the Patient Return Electrode receptacle on the generator Second REM electrode If the alarm clears leave the generator on during draping to avoid disturbing the return electrode Remove the return el
64. lidated infection control procedure Do not allow fluids to enter the chassis The generator cannot be sterilized Step 3 Ship the Generator A Attach a tag to the generator that includes the Return Authorization Number and the information hospital phone number etc listed in Step 1 Obtain a Return Authorization Number B Be sure the generator is completely dry before you pack it for shipment Package it in its original shipping container if available C Ship the generator prepaid to the Valleylab Service Center Force FX C User s Guide pue eoueugjure A Valleylab Service Centers Valleylab Service Centers For a complete list of service centers world wide please refer to the Valleylab website http www valleylab com valleylab international service world html 8 4 Force 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 input power voltage Force FX C User s Guide 9 1 Performance Characteristics Performance Characteristics General Output configuration Isolated output Cooling Natural convection side and rear panel vents fan Display Eight digital seven segment displays 1 9 0 75 in each Mounting Valleylab cart E8006 E8008 or UC8009 CUSA EXcel System CUSA System
65. ll inputs High Frequency RF Leakage Current Bipolar RF leakage lt 59 2 mA rms current Monopolar RF leakage lt 150 mA rms current additional tolerance CEM output modes lt 150 mA rms at 6 50 W 9 6 Force FX C User s Guide Performance Characteristics Input Power 100 120 Volt 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 100 132 Vac Input mains voltage full regulation range 208 264 Vac Input mains voltage operating range 85 132 Vac Input mains voltage operating range 170 264 Vac Mains current maximum Idle 0 4 A Bipolar 2 0A Cut 7 0A Coag 4 0A Mains current maximum Idle 0 2 A Bipolar 1 0 A Cut 3 5 Coag 2 0 A Mains line frequency range nominal 50 to 60 Hz Mains line frequency range nominal 50 to 60 Hz Fuses 2 F8 A Fuses 2 T4 A Power cord 3 prong hospital grade connector Power cord 3 prong locally approved connector Power Cord Specification This unit was equipped from the factory with either a hospital grade NEMA 5 15 power cord or a 220VAC CEE7 7 power cord Should the AC power cord need to be replaced to match another plug configuration the replacement plug cable receptacle configurati
66. m proper power settings before proceeding with surgery Use the lowest power setting possible for the minimum time necessary to achieve the desired effect Never increase the power settings without first checking both the active electrode and the patient return electrode and their connections Use the active electrode or forceps only for the minimum time necessary to achieve the desired surgical effect in order to minimize the possibility of burns This is especially true in pediatric and neonatal patients or in any patient where small appendages are involved During a surgical procedure the amount of current delivered during a given time period determines the amount of heating that occurs under the electrode All Valleylab patient return electrodes are designed for use during traditional surgical procedures and duty cycles on time compared to off time Users should consult Chapter 9 Technical Specifications for the recommended maximum duty cycle specifications It is 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 there can be greater risk that the heating under a fully applied return electrode may be high enough to injure the patient When using a
67. ment Handswitching instrument Setting the Bipolar Output Set power levels to the lowest setting before testing an accessory 1 Optional To display the previous settings press the Recall button 2 To set the bipolar mode press the Low Precise Med Standard or Macro Macrobipolar button The corresponding indicator illuminates green 3 To increase the power for the selected mode press the white up arrow A button To decrease the power press the white down arrow V button The maximum power setting is 70 watts 4 6 Force FX C User s Guide Preparing for Monopolar Surgery Preparing for Monopolar Surgery If you plan to use a footswitching monopolar instrument you must connect a Valleylab monopolar footswitch You may also use a footswitch to activate a handswitching instrument or a CUSA handpiece with CEM nosecone Connections for Monopolar Surgery Electric Shock Hazard Do not connect wet accessories to the generator Ensure that all accessories and adapters are correctly connected and that no metal is exposed Use only a Valleylab monopolar footswitch with the Force FX C generator Use of an incompatible footswitch may cause unexpected output Connect accessories to the proper receptacle Improper connection may result in inadvertent accessory activation or other potentially hazardous conditions Follow the instructions provided with electrosurgical accessories for proper connection and
68. n of protocol or change the default coag mode the generator which can then from Fulgurate to Desiccate or Spray Refer generate a response in the device to the Force FX C Electrosurgical Generator Service Manual 2 10 Force FX C 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 and followed Electrosurgery has been used safely in numerous 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 Force FX C User s Guide 3 1 General General Always use the lowest output setting necessary 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 Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the current flow an
69. n the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active Nonfunction of the generator may cause interruption of surgery A backup generator should be available for use Notice If required by local codes connect the generator to the hospital equalization connector with an equipotential cable Connect the power cord to a wall receptacle having the correct voltage Otherwise product damage may result Force FX C User s Guide 3 7 pue During Surgery During Surgery Generator Power Settings Confirm proper power settings before proceeding with surgery Use the lowest power setting possible for the minimum time necessary to achieve the desired effect Never increase the power settings without first checking both the active electrode and the patient return electrode and their connections Use the active electrode or forceps only for the minimum time necessary to achieve the desired surgical effect in order to minimize the possibility of burns This is especially true in pediatric and neonatal patients or in any patient where small appendages are involved The Force FX C Electrosurgical Generator cuts effectively at power settings lower than previous models offered by Valleylab If the proper setting is not known set the generator at a very low setting and cautiously increase the power until the desired e
70. nd ports Force FX C User s Guide 2 1 Front Panel Front Panel Recall button Pressing this button sets the generator to the most recently used mode and power settings Bipolar controls Cut controls REM alarm CEM indicator indicator Coag controls BIPOLAR CUT ORCE mi Fw Ww IIO V Standard C C Desiccate Fulgurate Spray Low REM Alari LOW MED HIGH BIPOLAR Bipolar Instrument receptacle Power Switch This switch supplies power to the generator Press to turn on the generator Press to turn off the generator MONOPOLAR 1 CEM Monopolar 1 CEM Instrument receptacle MONOPOLAR 2 PATIENT Monopolar 2 Instrument receptacle Patient return electrode receptacle For monopolar electrosurgery connect a patient return electrode to this receptacle 2 2 Force FX C User s Guide Bipolar Controls Bipolar Controls Bipolar indicator When you activate bipolar this indicator illuminates blue and an activation tone sounds Bipolar display Shows the power setting in watts for the selected mode BIPOLAR Power buttons eet TH 1 LA Press A to increase the power d V
71. ng the patient Place two to three inches of dry gauze between contact points to ensure that contact does not occur Position the patient return electrode to provide a direct current route between the 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 Potential for alternate site burns increases if the return electrode is compromised Valleylab recommends the use of REM patient return electrodes and Valleylab generators with the REM system 1 U S Department of Health and Human Services National Institute for Occupational Safety and Health NIOSH Control of Smoke from Laser Electric Surgical Procedures HAZARD CONTROLS Publication No 96 128 September 1996 8 4 Force FX C User s Guide Before Surgery Ensure Proper Connections Examine all accessories and connections to the electrosurgical generator before using Ensure that the accessories function as intended Improper connection may result in arcs sparks accessory malfunction or unintended surgical effects Accessories Warning Do not wrap the accessory 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 Servicing Warning Electric Shock Hazard Do not remove the cover Contact authorized personnel for service Noti
72. nopolar Coag Desiccate 3500 V 500 Q 70 W 5 An indication of a waveform s ability to coagulate bleeders without a cutting effect 9 10 Force User s Guide Output Characteristics Available Power Settings in Watts Bipolar and Macrobipolar 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 Monopolar Cut Low and 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 20 210 220 230 20 250 260 270 280 290 300 Monopolar Cut 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 Force FX C User s Guide 9 11 eoiuuo9 Output Characteristics Monopolar Coag 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 10 120 CEM Cut 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 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 9
73. nstructions If you are familiar with the Force FX C generator you may prefer to follow this abbreviated procedure If however you are not familiar with how the generator should be set up detailed instructions follow this chapter 1 Plug the generator power cord into the rear panel receptacle Plug the generator power cord into a grounded wall receptacle 2 3 4 Turn on the generator and verify that the self test is successfully completed Prepare for bipolar monopolar or ultrasonic electrosurgery To prepare for bipolar or monopolar surgery If using a footswitch connect it to the appropriate Valleylab footswitch receptacle on the rear panel Connect the instrument to the appropriate instrument receptacle on the front panel For simultaneous coag monopolar surgery connect a monopolar accessory or a CUSA handpiece with CEM nosecone to the Monopolar 1 CEM Instrument receptacle Connect a second monopolar accessory to the Monopolar 2 Instrument receptacle For monopolar surgery only apply the patient return electrode to the patient and connect it to the Patient Return Electrode receptacle on the front panel Verify or change the mode and power settings Optional Press the Recall button on the front panel to display the previously used settings To prepare for ultrasonic surgery Assemble and sterilize the CUSA handpiece and CEM nosecone Set up the CUSA System If using a footsw
74. on 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 HOSVVF3G1 0 VDE maximum length 15 5 meters Plug minimum 6 A 250VAC Unit receptacle IEC female minimum 6 A 250VAC Force FX C User s Guide suoneouioeds eoiuuo9 Standards and IEC Classifications Standards and IEC Classifications The Force FX C generator meets all pertinent clauses of the IEC 60601 1 second edition and IEC 60601 2 2 third edition gt wk t US MEDICAL EQUIPMENT UL 60601 1 CAN CSA C22 2 NO 601 1 47AK E199592 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 remove the cover Refer servicing to qualified service personnel 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 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 The Fo
75. one alerts the surgical team when an accessory is active When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard Notice If required by local codes connect the generator to the hospital equalization connector with an equipotential cable Connect the power cord to a wall outlet having the correct voltage Otherwise product damage may result 1 Verify the generator is off by pressing the power switch off O 2 Place the generator on a stable flat surface such as a table platform or Valleylab cart Carts with conductive wheels are recommended For details refer to the procedures for your institution or to local codes Provide at least four to six inches of space from the sides and top of the generator for cooling Normally the top sides and rear panel are warm when the generator is used continuously for extended periods of time You can also mount the generator on the CUSA EXcel system and CUSA System 200 using the optional CUSA mounting brackets Force FX C User s Guide 4 3 eJojeg Setting Up the Generator gt Important If the coag mode has been optionally changed to default to Desiccate or Spray that corresponding indicator illuminates after the self test is performed successtully Plug the generator po
76. ootswitch to activate a handswitching instrument Connections for Bipolar or Macrobipolar Surgery Electric Shock Hazard Do not connect wet accessories to the generator Ensure that all accessories and adapters are correctly connected and that metal is exposed Do not apply a patient return electrode if only bipolar accessories are being used Otherwise the electrosurgical effect may not be limited to the tissue between the bipolar electrodes Read the instructions warnings and cautions provided with electrosurgical accessories before using Specific instructions are not included in this manual Inspect accessories and cords especially reusable accessories and cords for breaks cracks nicks or 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 Accessories must be connected to the proper receptacle type In particular bipolar accessories must be connected to the Bipolar receptacle only Improper connection may result in inadvertent generator activation or a REM Contact Quality Monitor alarm BIPOLAR FOOTSWITCH Footswitching or handswitching instrument Bipolar footswitch Force FX C User s Guide 4 5 eJojeg Preparing for Bipolar Macrobipolar Surgery Figure 4 2 Connection for bipolar or macrobipolar surgery using a handswitching instru
77. or Setting Force FX C User s Guide Output Characteristics Desiccate 3 Coag Mode 80 Output power vs impedance for Desiccate 3 coag 60W mode 70 60 50 dtm 30 20 10 Output Power watts 0 F s r sr rp 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms Oulput power vs impedance for 180 Desiccate 3 coag 120W mode 140 120 100 80 60 40 20 Output Power watts 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms suoneouioeds eoiuuo9 Force FX C User s Guide 9 31 Output Characteristics 70 80 90 100 110 120 60 Output Power watts 40 FNTT HAUNT 30 20 10 e e e e 500 uedo spem 1ewog 1ndino output power for Desiccate 3 coag mode settings Desiccate 3 coag mode Open circuit peak voltage vs Output power vs generator Force FX C User s Guide Generator Setting 9 32 Output Characteristics Fulgurate Coag Mode 80 Output power vs impedance Fulgurate coag 60W mode 70 60 50 g 4 40 5 30 5 20 5 amp 10 2 0 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms 160 Output power vs impedance Fulgurate coag 120W mode 140 120 100 80 60 40 20 Output Power watts 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms Fo
78. or electrical shock to the patient or surgical team Do not reuse or resterilize accessories labeled disposable or single use only Patient Return Electrodes Valleylab recommends the use of REM patient return electrodes to maximize patient safety The safe use of monopolar electrosurgery requires proper placement of the patient return electrode To avoid electrosurgical burns beneath the patient return electrode follow 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 Do not apply a patient return electrode if only bipolar accessories are being used Otherwise the electrosurgical effect may not be limited to the tissue between the bipolar electrodes Using a patient return electrode without the REM safety feature will not activate the Valleylab REM Contact Quality Monitoring System Valleylab recommends against the use of capacitive pads These pads do not activate the REM Contact Quality Monitoring System and require the use of higher power settings to achieve the desired surgical effect This increases the possibility of alternate site burns Shunt Cords Some surgical instruments e g colonoscopes may allow substantial leakage current which could burn the surgeon If the instrument manufacturer recommends the use of a shunt cord s cord to direct the current back to th
79. orce FX C User s Guide 2 9 s op d 5 tJ pue SJOJEOIPU S O1JUOD Activation Tone Volume Control Activation Tone Volume Control Option Panel Turn to adjust the volume of the tones that sound when the generator is activated activation tone To ensure that the surgical team is alerted to inadvertent activation these tones cannot be silenced To increase the volume of activation tones turn the knob clockwise To decrease the volume turn the knob counterclockwise A removable plate on the rear panel covers a serial port an expansion port and an RF radio frequency activation port Remove this plate to obtain information through the RS 232 port or to install a peripheral device such as a Bipolar Current Monitor but retain the original cover plate After obtaining information or removing a peripheral device reinstall the original cover plate Notice Do not operate the Force FX C without an appropriate cover plate in place To review the technical specifications for each port refer to Chapter 9 Output Characteristics Expansion port Allows a connected device to receive information about the RF voltage and current being generated as well as signal the generator to halt RF output Serial port Allows connection of a computer to the RF activation port generator You can obtain information about Allows a connected device to receive the generator using RS 232 communications information during RF activatio
80. patient and the grounded object if possible Continually monitor the contact point s Active Accessories Fire Hazard Do not place active accessories near or in contact with flammable materials such as gauze or surgical drapes Electrosurgical accessories that are activated or hot from use can cause a fire Use a holster to hold electrosurgical accessories safely away from patients the surgical team and flammable materials 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 Force FX C User s Guide 3 9 pue 1 During Surgery 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 are possible To minimize the risk 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 Use the lowest power setting possible for the minimum time necessary to achieve hemostasis Activate the generator after the accessory makes contact with the hemostat Do not arc to the hemostat Firmly grasp as much of the hemostat as possible before activating the generator This disperses the current over a la
81. put Power watts Generator Setting 9 18 Force FX C User s Guide Output Characteristics Output power vs impedance for Macrobipolar 35W mode Output power vs impedance for Macrobipolar 70W mode Macrobipolar Mode Output Power watts Output Power watts 50 45 40 35 30 25 20 15 10 5 0 90 80 70 60 50 40 30 20 10 10 30 50 70 90 200 400 475 495 515 600 800 1000 Load Resistance ohms 10 30 50 70 90 200 400 475 495 515 600 800 1000 Load Resistance ohms Force User s Guide suoneouioeds eoiuuoo Output Characteristics Open circuit peak voltage vs output power for Macrobipolar mode Output power vs generator settings Macrobipolar mode Open Circuit Peak Voltage volts Output Power watts 400 350 300 250 200 150 100 50 20 30 40 Output Power watts 50 60 70 30 40 Generator Setting 9 20 Force FX C User s Guide Output Characteristics Monopolar Cut Graphs These measurements were taken using short lt 0 5 meter leads Low Cut Mode Output power vs impedance for 200 Low cut 150W mode 180 160 140 120 100 80 60 40 20 0 Output Power watts 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms Output power vs impedance for 400 Low cut 300W mode 350 300 250 200 150 Output Power watts 100 50 50 100 300 500
82. r s Guide 4 13 eJojeg Preparing for Ultrasonic Electrosurgery Figure 4 8 If you choose to use a monopolar Connection for combined footswitch you must use a Valleylab monopolar ultrasonic surgery monopolar foootswitch and connect it to the Monopolar 1 Footswitch receptacle mmm CEM indicator illuminates green CUSA handpiece with CEM n Patient return electrode Setting the Output Power Caution Set power levels to the lowest setting before testing an accessory When you use the CUSA handpiece with CEM nosecone for ultrasonic electrosurgery only Low cut or Desiccate coag are available when you activate the handpiece To verify or change the Low cut power setting To increase the power press the yellow up arrow A button To decrease the power press the yellow down arrow V button The maximum cut power is 100 watts To verify or change the Desiccate coag power setting To increase the power press the blue up arrow A button To decrease the power press the blue down arrow V button The maximum coag power is 70 watts 4 14 Force FX C User s Guide Preparing for Ultrasonic Electrosurgery Simultaneous Coag To use a CUSA handpiece with CEM nosecone for simultaneous coag connect the handpiece to the Monopolar 1 CEM Instrument receptacle Then connect a monopolar instrument to the Monopolar 2 Instrument receptacle During simultaneous coag only Desiccate coag
83. rator on top of electrical equipment except a Force GSU unit or a Force Argon unit These configurations are unstable and or do not allow for adequate cooling Two generators and two patient return electrodes may be used simultaneously on the same patient provided the generators are the same type both are isolated or both are ground referenced However the two generators are not synchronized One return electrode frequently acquires a high positive voltage while the other acquires an opposite negative voltage When this occurs the potential voltage difference between them may cause the current to flow from one patient return electrode to the other The current causes no harm if it produces no sparks or high current densities on the patient Place each patient return electrode as close as possible to the site of the surgery to be performed by the generator to which it is connected Ensure that the two patient return electrodes do not touch Pacemakers Use electrosurgery with caution in the presence of internal or external pacemakers Interference produced by the use of electrosurgical devices can cause devices such as 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 electrosurgical appliances is planned in patients with cardiac pacemakers If the patient has an internal cardiac defibrillator ICD
84. rce FX C User s Guide 9 33 eoiuuo9 5000 4500 Output power vs peak voltage Output Characteristics Fulgurate coag mode 110 120 100 Output Power watts syo eBeyoA NID uedo spem 1ndino Output power vs generator settings Fulgurate coag mode Force FX C User s Guide Generator Setting 9 34 Output Characteristics Output power vs impedance LCF Fulgurate coag GOW mode Output power vs impedance LCF Fulgurate coag 120W mode LCF Fulgurate Coag Mode Output Power watts Output Power watts 80 70 60 50 40 30 20 10 160 140 120 100 80 60 40 20 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms 50 100 300 500 700 900 1200 1600 2000 Load Resistance ohms Force FX C User s Guide 9 35 eoiuuoo Output Characteristics 3500 Output power vs peak voltage LCF Fulgurate mode 3000 2500 2000 1500 1000 Open Circuit Peak Voltage volts 500 1 10 20 30 40 50 60 70 80 90 100 110 120 Output Power watts Output power vs generator settings LCF Fulgurate mode Output Power watts 11 1 sm pL isu NE pp Ep MEE EN UN el sss EERENSHEEERE E LLEELEELLLTIN
85. rce FX C 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 The Force FX C generator patient return electrode terminal is protected from defibrillator discharge according to ANSI AAMI HF18 and IEC 60601 2 2 9 8 Force FX C User s Guide Standards and IEC Classifications Liquid Spillage IEC 60601 2 2 Clause 44 3 The Force FX C generator enclosure is constructed so that liquid spillage in normal use des not wet electrical insulation or other components which when wetted are likely to adversely affect the safety of the equipment Electromagnetic Interference When placed on or beneath an activated Valleylab electrosurgical generator the Force FX C generator operates without interference The generator minimizes electromagnetic interference to video equipment used in the operating room Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 The Force FX C generator complies with the appropriate IEC 60601 1 2 and 60601 2 2 specifications regarding electromagnetic compatibility Applied Parts E2515 E2516 E2003 E4053 CT E7507 E7506 E6008B and E6009 were tested with the unit and the combination was found to be in compliance with IEC 60601 2 2 Third Edition Safety of use of other accessories not identified in these instructions has not been
86. rger 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 When using a stainless steel blade electrode place the flat surface against the hemostat or other metal instrument When using a coated or nonstick blade electrode place the edge of the electrode against the hemostat or other metal instrument When not using active accessories place them in a holster or in a clean dry nonconductive and highly visible area not in contact with the patient Inadvertent contact with the patient may result in burns Patient Return Electrodes To avoid patient burns ensure that the patient return electrode firmly contacts the skin Always check the patient return electrode periodically and after the patient is repositioned and during procedures involving long periods of activation 3 10 Force FX C User s Guide During Surgery 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 Loc
87. rrow cut down arrow and or a cut mode button Low Pure Blend may be stuck 192 Coag up arrow coag down arrow and or a coag mode button Desiccate Fulgurate Spray may be stuck 193 Recall button may be stuck 194 Handswitch or Monopolar 1 Footswitch cut pedal may be stuck 195 Handswitch or Monopolar 1 Footswitch coag pedal may be stuck 196 Handswitch or Monopolar 2 Footswitch cut pedal may be stuck 197 Handswitch or Monopolar 2 Footswitch coag pedal may be stuck 198 Handswitch or Bipolar Footswitch pedal may be stuck 199 203 Internal diagnostics or microcontroller malfunction 206 207 Software malfunction 208 209 Microcontroller malfunction 210 211 Software malfunction 212 213 Internal diagnostics 215 220 226 Internal diagnostics or microcontroller malfunction 230 231 Software malfunction Recommended Action 1 Turn off then turn on the generator Do not press buttons or accessory activation devices during the self test 2 If the alarm number reappears disconnect all accessories Then turn off and turn on the generator again If the alarm number reappears record the number and call the Valleylab Service Center Contact your Biomedical Engineering Department Turn off then turn on the generator If the alarm number reappears record the number and call the Valleylab Service Center Contact your Biomedical Engineering Department Turn off then turn on the generator If the alarm number reapp
88. se in the initial measured contact resistance whichever is less Patient return electrode without the REM safety feature single section electrode 0 to 20 ohms If the measured resistance is outside the acceptable range s noted above a REM fault condition occurs Force User s Guide Performance Characteristics 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 initial measured contact resistance increases by 40 whichever is less the REM Alarm indicator flashes red a tone sounds twice and RF output is disabled The indicator remains illuminated red until you correct the condition causing the alarm Then the indicator illuminates green and RF output is enabled Patient return electrode without the REM safety feature When the measured resistance between the patient return electrode pins exceeds 20 ohms the REM Alarm indicator flashes red a tone sounds twice and RF output is disabled The indicator remains illuminated red until you correct the condition causing the alarm Then the red indicator is extinguished and RF output is enabled Serial Port RS 232 compatible 9600 baud 8 data bits 1 stop bit no parity The 9 pin connector supports the following signals e Pin 2 isolated transmit serial data output transmit line Pin isolated receive serial data input receive line
89. snseaeaeseesneaeaneasaneesenenssaeanseesneaeaneassnee 1 2 Bipolar Vod68S 1 3 Monopolar Cut anid Coag Modes u 1 3 Simultaneous COAG 1 4 REM Contact Quality Monitoring System U u u uu uuu 1 4 How the REM System WorkSss usu usa uu 1 4 Electrodes Without the REM Safety Feature I u uuu uuuuuuuuuu 1 5 a 1 5 Chapter 2 Controls Indicators and Receptacles Front Panel M 2 2 Bipolar COMMONS a Nc CEDE 2 3 Bipolar Instrument Receptacle 1 esee nne tunm amans 2 4 Cut Controls pE 2 5 Monopolar Coag Controls idera derent ette AE 2 6 Monopolar Instrument Receptacles SEN EKA 2 7 gius Taille dee 2 7 Rear Panel 2 8 FOOUSWItCh RECEPLACIOS 2 9 Monopolar Footswitch Receptacles 2 9 Bipolar Footswitch Receptacle nasicornis ana anana Naaa En EN NANEN S NAi KAEA SA AN AAA N
90. te 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 Force FX C User s Guide This warranty 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 Force FX C User s Guide Kalleylab vi Force FX C User s Guide Table of Contents Foreworda yuy Ee c Er ii Conventions Used in this Guide U Su nennen ntn tasa sna iii iv 2 n uba SS vii Chapter 1 Introducing the Force FX C Electrosurgical Generator Instant Response TOCHNOlOGY cessscececescenesseessenesssecssecenseessseessseesseeessneesen
91. the patient return electrode and the patient The REM system is designed to minimize the risk of burns at the return electrode site due to a reduction in patient contact area during monopolar electrosurgery Use of any return electrode other than a REM patient return electrode may compromise the REM safety feature This could result in a patient burn How the REM System Works 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 A REM alarm sounds and the generator 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 40 from the initial measurement 1 4 Force FX C User s Guide Ultrasonic Electrosurgery Electrodes Without the REM Safety Feature Using a conventional patient return electrode without the REM safety feature will not activate the Valleylab REM Contact Quality Monitoring System When you use a patient return electrode that does not have the REM safety feature the REM system cannot monitor t
92. ting the Volume of Activation Tones Adjusting the Volume of Activation Tones Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active To change the volume of activation tones turn the Volume knob on the rear panel Clockwise to increase the volume Counterclockwise to decrease the volume You cannot silence the activation tones or adjust the alarm tone volume Responding to Alarms gt important After successful completion of the self test the REM Alarm indicator flashes red and a tone sounds twice No corrective action is required REM Alarm A tone sounds twice and the REM Alarm indicator flashes red The indicator remains red and RF output is disabled until the alarm condition is corrected When you correct a REM alarm condition output is enabled and the REM Alarm indicator illuminates green Alarm Situations The following conditions can generate a REM alarm The patient return electrode is not connected to the generator when the generator is activated for monopolar surgery The return electrode does not have adequate contact with the patient The contact area is reduced due to movement loss of adhesion fluid pooling or dry contact gel The return electrode cord is damaged causing excessive resistance To correct an alarm condition refer to Chapter 7 Correcting a REM Alarm Condition Non REM Patient Return Ele
93. tional fulgurate mode LCF fulgurate are provided in Chapter 4 Before Surgery This is the default monopolar coag mode However the default coag mode can be changed to either Desiccate or Spray through the serial port on the rear panel contact your institution s Biomedical Engineering Department 2 6 Force FX C User s Guide Monopolar Instrument Receptacles Monopolar Instrument Receptacles 0 1 MONOPOLAR 2 The instrument receptacles on this generator 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 You can connect a footswitching or handswitching monopolar instrument to the monopolar receptacles Some footswitching instruments may require a single pin adapter E0502 Series available from Valleylab Connect one monopolar instrument to the Monopolar 1 CEM Instrument receptacle single pin footswitching instrument or a three pin handswitching instrument or A four pin CUSA handpiece with CEM nosecone The CEM indicator in the upper right of the front panel illuminates green Refer to Chapter 4 Connecting the CUSA Handpiece with CEM Nosecone Connect one monopolar instrument to the Monopolar 2 Instrument receptacle A single pin footswitching instrument or a three pin handswitching instrument
94. tor that provides power for cutting desiccating and fulgurating tissue during bipolar and monopolar surgery Features include Instant Response Technology Three bipolar modes precise low standard medium and macro macrobipolar Three monopolar cut modes low pure and blend Three monopolar coag modes desiccate low fulgurate medium and spray high Support for simultaneous coagulation The Valleylab REM Contact Quality Monitoring System Support for ultrasonic electrosurgery using CUSA System 200 or CUSA EXcel and a CUSA handpiece with CUSA electrosurgical module CEM nosecone Handswitch or footswitch activation Recall of most recently used mode and power settings Adjustable activation tone volume An RF activation port RS 232 serial port and expansion port Force GSU system and Force Argon system compatibility Valleylab electrosurgical generators patient return electrodes and active accessories are designed to work as a system Valleylab offers a selection of patient return electrodes and electrosurgical instruments that are fully compatible with this generator When considering other manufacturer s patient return electrodes and or active accessories customers should seek detailed user instructions and warning information from the manufacturer Instant Response Technology The Force FX C generator automatically senses resistance and adjusts the output voltage to ma
95. wer cord into the rear panel receptacle Plug the generator power cord into a grounded receptacle Turn on the generator by pressing the power switch on Verify the following visual indicators and displays on the front panel illuminate Activation tones sound to verify that the speaker is working properly If the self test is successful a tone sounds Verify the following Indicators above the default mode buttons Standard bipolar Pure cut and Fulgurate coag illuminate green Each display shows a power setting of 1 watt The REM Alarm indicator illuminates red If the self test is not successful an alarm tone sounds A number may momentarily appear in the Cut display and in most cases the generator is disabled Note the number and refer to Chapter 7 Responding to System Alarms Once the self test is successful connect the accessories and set the generator controls Refer to Preparing for Bipolar or Macrobipolar Surgery Preparing for Monopolar Surgery or Preparing for Ultrasonic Electrosurgery in this chapter Force User s Guide Preparing for Bipolar Macrobipolar Surgery Preparing for Bipolar or Macrobipolar Surgery Figure 4 1 Connection for bipolar or macrobipolar surgery using footswitch activation and a handswitching or footswitching instrument If you plan to use a footswitching bipolar instrument you must connect a bipolar footswitch You may also use a f

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