Covidien Force FX-C User Manual Download Page 130

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Part No. 1012638

COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and
internationally registered trademarks of Covidien AG.

CUSA, CUSA EXcel and CEM are trademarks of Integra LifeSciences
Corporation or its subsidiary.
Other brands are trademarks of a Covidien company.

One or more U.S. Patents 5,599,344; 5,628,745; 6,203,541.

2011 Covidien.

Made in USA. Printed in USA.

Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.

Covidien Ireland Limited, IDA Business & Technology Park,

Tullamore.

www.covidien.com 1-303-530-2300 [T]

1-800-255-8522 [T]
REV 02/2011

Consult

instructions

for use

Summary of Contents for Force FX-C

Page 1: ...User s Guide Force FX TM Electrosurgical Generator C...

Page 2: ......

Page 3: ...User s Guide Force FX TM Electrosurgical Generator C 1012638...

Page 4: ...available in the Force FX Electrosurgical Generator C Service Manual Equipment covered in this manual Force FX Electrosurgical Generator C 110 V Nominal 230 V Nominal auto select Conventions Used in t...

Page 5: ...hall be limited to the aggregate purchase price for the products sold to the customer This limited warranty is non transferable and runs only to the original purchaser of the covered product s There a...

Page 6: ...right to make changes in covered products built or sold by it at any time without incurring any obligation to make the same or similar changes to equipment previously built or sold by it THE OBLIGATI...

Page 7: ...tors and Receptacles Front Panel 2 2 Bipolar Controls 2 3 Bipolar Instrument Receptacle 2 4 Monopolar Cut Controls 2 5 Monopolar Coag Controls 2 6 Monopolar Instrument Receptacles 2 7 REM Alarm Indica...

Page 8: ...r Macrobipolar Surgery 4 5 Setting the Bipolar Output 4 6 Preparing for Monopolar Surgery 4 7 Connections for Monopolar Surgery 4 7 Applying a Patient Return Electrode to the Patient 4 9 Using Two Gen...

Page 9: ...ing a REM Alarm Condition 7 2 Applying Additional Patient Return Electrodes 7 3 Correcting Malfunctions 7 5 Responding to System Alarms 7 10 Chapter 8 Maintenance and Repair Responsibility of the Manu...

Page 10: ...oof 9 10 Liquid Spillage IEC 60601 2 2 Clause 44 3 9 10 Electromagnetic Interference 9 10 Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 9 10 Voltage Transients Emergency Generator Main...

Page 11: ...r cut and coag modes Simultaneous coag REM Contact Quality Monitoring System Ultrasonic electrosurgery Caution Read all warnings cautions and instructions provided with this generator before using Rea...

Page 12: ...dien electrosurgical generators patient return electrodes and active accessories are designed to work as a system Covidien offers a selection of patient return electrodes and electrosurgical instrumen...

Page 13: ...used for a 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 b...

Page 14: ...o become concentrated potentially resulting in burns at the return electrode site The Force FX C generator uses the REM Contact Quality Monitoring System to monitor the quality of electrical contact b...

Page 15: ...ther simultaneously or independently In addition to convenience the combination of ultrasonic vibration plus simultaneous electrosurgical current prevents charring of the tip and decreases sticking an...

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Page 17: ...lectrosurgical Generator C User s Guide 2 1 Controls Indicators and Receptacles This chapter describes the front and rear panels including all controls indicators receptacles the fuse drawer and ports...

Page 18: ...t controls Coag controls CEM indicator Bipolar Instrument receptacle Monopolar 1 CEM Instrument receptacle Monopolar 2 Instrument receptacle Power Switch This switch supplies power to the generator Pa...

Page 19: ...ower buttons Press to increase the power Press to decrease the power Mode indicators Illuminate green when you press the corresponding mode button Macro mode button Select for macrobipolar output Stan...

Page 20: ...polar receptacle Connect a footswitching instrument with a two pin connector or Connect a handswitching instrument with a three pin connector Caution Accessories must be connected to the proper recept...

Page 21: ...buttons Press to increase the power Press to decrease the power Mode indicators Illuminate green when you press the corresponding mode button Blend mode button Select for slower cutting and additiona...

Page 22: ...gurate 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 def...

Page 23: ...tswitching 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 Connecti...

Page 24: ...enerator 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 f...

Page 25: ...Electrosurgical Generator C User s Guide 2 9 Rear Panel Volume control Option panel Bipolar Footswitch receptacle Equipotential grounding lug Use to connect the generator to earth ground Line fuse loc...

Page 26: ...eceptacle The connected footswitch activates monopolar output for the instrument that is connected to the Monopolar 1 CEM Instrument receptacle on the front panel Connect a two pedal monopolar footswi...

Page 27: ...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 a...

Page 28: ...Output Characteristics on page 9 11 Notice Do not operate the Force FX C generator without an appropriate cover plate in place Expansion port Allows a connected device to receive information about the...

Page 29: ...erating 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 procedu...

Page 30: ...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 pla...

Page 31: ...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 Warning Fir...

Page 32: ...ntact 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 pote...

Page 33: ...d Ensure that all accessories and adapters are correctly connected and that no metal is exposed Caution Read the instructions warnings and cautions provided with electrosurgical accessories before usi...

Page 34: ...itive 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 al...

Page 35: ...nerator 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 equipote...

Page 36: ...switch mechanism in saline solution or other conductive fluids Unintended activation may result Warning Contact of the active electrode with any metal such as hemostats Gomco clamps Kocher clamps etc...

Page 37: ...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...

Page 38: ...rrent 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 coupli...

Page 39: ...ectric Shock Hazard Always turn off and unplug the generator before cleaning Caution Do not reuse or resterilize accessories labeled disposable or single use only Notice Do not clean the generator wit...

Page 40: ......

Page 41: ...polar or macrobipolar surgery Preparing for monopolar surgery Preparing for ultrasonic electrosurgery Caution Read all warnings cautions and instructions provided with this generator before using Read...

Page 42: ...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 monop...

Page 43: ...been completed as described Otherwise inaccurate power outputs may result Caution Do not stack equipment on top of the generator or place the generator on top of electrical equipment except a Force G...

Page 44: ...splay 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 cas...

Page 45: ...trode if only bipolar accessories are being used Otherwise the electrosurgical effect may not be limited to the tissue between the bipolar electrodes Caution Read the instructions warnings and caution...

Page 46: ...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 th...

Page 47: ...ries to the proper receptacle Improper connection may result in inadvertent accessory activation or other potentially hazardous conditions Follow the instructions provided with electrosurgical accesso...

Page 48: ...M Instrument receptacle Connection for monopolar surgery using footswitch activation and a footswitching or handswitching instrument using Monopolar 2 Footswitch receptacle and Monopolar 2 Instrument...

Page 49: ...tructions for application site and placement procedures When using metal plate patient return electrodes use a conductive gel specifically designed for electrosurgery Warning The safe use of monopolar...

Page 50: ...makers 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...

Page 51: ...ate mode press the Med button and hold for two seconds 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 ar...

Page 52: ...ndswitching instruments Connection for simultaneous coag using two footswitching instruments Monopolar instrument or CUSA handpiece with CEM nosecone Patient return electrode Monopolar instrument Mono...

Page 53: ...Electrode to the Patient on page 4 9 Connecting the CUSA Handpiece with CEM Nosecone Warning Electric Shock Hazard Do not connect wet accessories to the generator Ensure that all accessories and adap...

Page 54: ...on for combined monopolar ultrasonic surgery CUSA handpiece with CEM nosecone Patient return electrode Connect to CUSA system If you choose to use a monopolar footswitch you must use a Valleylab monop...

Page 55: ...0 watts To verify or change the Desiccate coag power setting To increase the power press the blue up arrow button To decrease the power press the blue down arrow button The maximum coag power is 70 wa...

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Page 57: ...he mode Selecting the power setting Activating the surgical instrument Adjusting the volume of activation tones Responding to alarms Caution Read all warnings cautions and instructions provided with t...

Page 58: ...ns 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...

Page 59: ...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 gen...

Page 60: ...ample 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 ti...

Page 61: ...s achieved Power Surgical Procedure Low Power 30 watts Dermatology Laparoscopic sterilization both bipolar and monopolar Neurosurgery both bipolar and monopolar Oral surgery Plastic surgery Vasectomie...

Page 62: ...iminate the possibility of current dispersal Notice Do not activate the generator until the forceps have made contact with the patient Product damage may occur Handswitching Footswitching Activation I...

Page 63: ...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...

Page 64: ...xtinguished 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 o...

Page 65: ...Force FX Electrosurgical Generator C User s Guide 6 1 After Surgery This chapter instructs you on Preparing the generator for reuse Storing the generator Chapter 6...

Page 66: ...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 gener...

Page 67: ...Force FX Electrosurgical Generator C User s Guide 7 1 Troubleshooting This chapter includes Correcting a REM alarm condition Correcting malfunctions Responding to system alarms Chapter 7...

Page 68: ...nnection 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 electrod...

Page 69: ...next step 2 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 3 Apply a second patient return electrod...

Page 70: ...e patient return electrode from the generator Use a Covidien multiple return S cord adapter E0507B to connect two patient return electrodes to the generator a Insert the adapter into the Patient Retur...

Page 71: ...r during coag Use a lower power setting for the Fulgurate and the Spray modes or select the Desiccate mode Abnormal 50 60 Hz leakage currents Refer to your Biomedical Engineering Department or contact...

Page 72: ...is on but did not complete the self test Software malfunction Turn off then turn on the generator Internal component malfunction Use a backup generator Refer to your Biomedical Engineering Department...

Page 73: ...2 Footswitch receptacle or Connect the instrument to the Monopolar 1 CEM receptacle Footswitch connected to Monopolar 2 Footswitch receptacle is being used for instrument connected to Monopolar 1 CEM...

Page 74: ...r devices only when the generator is activated Metal to metal sparking High settings used for fulguration High settings used for fulguration Electrically inconsistent ground wires in the operating roo...

Page 75: ...n 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 wher...

Page 76: ...the generator If the alarm number reappears record the number and call the Covidien Service Center 11 Microcontroller malfunction Contact your Biomedical Engineering Department 12 Software malfunction...

Page 77: ...121 Software malfunction Turn off then turn on the generator If the alarm number reappears record the number and call the Covidien Service Center 122 123 126 Calibration malfunction Microcontroller m...

Page 78: ...tware malfunction Turn off then turn on the generator If the alarm number reappears record the number and call the Covidien Service Center 180 185 Internal diagnostics Contact your Biomedical Engineer...

Page 79: ...ow 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 Mon...

Page 80: ...ontact your Biomedical Engineering Department 240 242 244 245 Software malfunction Turn off then turn on the generator If the alarm number reappears record the number and call the Covidien Service Cen...

Page 81: ...urgical Generator C User s Guide 8 1 Maintenance and Repair Refer to this chapter for information on The manufacturer s responsibility Routine maintenance Returning the generator for service Service c...

Page 82: ...Maintenance When should the generator be checked or serviced Covidien recommends that the generator be inspected by qualified service personnel at least twice a year This inspection should include che...

Page 83: ...stomer 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 A Turn off the gene...

Page 84: ...c 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...

Page 85: ...uide 9 1 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 77 F 25...

Page 86: ...carts CUSA EXcel System CUSA System 200 using CUSA System 200 optional mounting brackets a Force GSU unit an Argon Gas Delivery Unit II or any stable flat surface Width 14 35 6 cm Depth 18 45 7 cm He...

Page 87: ...Memory Ambient temperature range 40 to 158 F 40 to 70 C Relative humidity 25 to 85 noncondensing Atmospheric pressure 500 to 1060 millibars Duration of storage If stored longer than one year the batt...

Page 88: ...er Alarm tones meet the requirements for IEC 601 2 2 Activation Tone Alarm Tone REM Contact Quality Monitor REM current is measured according to IEC 601 1 Ed 1988 Figure 15 Volume adjustable 45 to 65...

Page 89: ...d 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 resistan...

Page 90: ...al 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 pi...

Page 91: ...e 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 m...

Page 92: ...he AC power cord need to be replaced to match another plug configuration the replacement plug cable receptacle configuration must meet or exceed the following specifications 100 120 VAC Cable SJT16 3...

Page 93: ...e event of a basic insulation failure because of the way in which they are connected to the protective earth conductor ATTENTION Consult accompanying documents The generator output is floating isolate...

Page 94: ...ination 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 determined by Underwriters Laboratories Inc...

Page 95: ...An indication of a waveform s ability to coagulate bleeders without a cutting effect Mode Open Circuit P P Voltage max Rated Load max Power max Crest Factor Bipolar Precise Standard Macro 450 V 320 V...

Page 96: ...leeders without a cutting effect Available Power Settings in Watts Bipolar and Macrobipolar Mode Open Circuit P P Voltage max Rated Load max Power max Crest Factor Monopolar Cut Low 1000 V 300 100 W 1...

Page 97: ...15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 45 50 55 60 65 70 75 80 85 90 95 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 290 300 1 2 3...

Page 98: ...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 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18...

Page 99: ...y constant power followed by constant voltage The maximum output voltage is controlled to reduce capacitive coupling and video interference and to minimize sparking Bipolar Monopolar Cut 1 2 3 4 5 6 7...

Page 100: ...sinusoidal bursts with a repetition frequency of 30 kHz into 500 ohms LCF Fulgurate 470 kHz damped sinusoidal bursts with a repetition frequency of 57 kHz into 500 ohms Spray 470 kHz damped sinusoida...

Page 101: ...ific power 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 i...

Page 102: ...ctrosurgical Generator C User s Guide Output power vs impedance for Precise bipolar 70W mode Open circuit peak voltage vs output power for Precise bipolar mode Load Resistance ohms Output Power watts...

Page 103: ...ce FX Electrosurgical Generator C User s Guide 9 19 Output power vs generator settings Precise bipolar mode Standard Bipolar Mode Output power vs impedance for Standard bipolar 35W mode Output Power w...

Page 104: ...ensed 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 powe...

Page 105: ...lectrosurgical Generator C User s Guide 9 21 Open circuit peak voltage vs output power for Standard bipolar mode Open circuit peak voltage vs output power for Standard bipolar mode Output Power watts...

Page 106: ...FX Electrosurgical Generator C User s Guide Macrobipolar Mode Output power vs impedance for Macrobipolar 35W mode Output power vs impedance for Macrobipolar 70W mode Load Resistance ohms Output Power...

Page 107: ...Force FX Electrosurgical Generator C User s Guide 9 23 Open circuit peak voltage vs output power for Macrobipolar mode Output power vs generator settings Macrobipolar mode Output Power watts Open Circ...

Page 108: ...9 24 Force FX Electrosurgical Generator C User s Guide Monopolar Cut Graphs These measurements were taken using short 0 5 meter leads Low Cut Mode Output power vs impedance for Low cut 150W mode Load...

Page 109: ...ns Force FX Electrosurgical Generator C User s Guide 9 25 Output power vs impedance for Low cut 300W mode Open circuit peak voltage vs output power for Low cut mode Load Resistance ohms Output Power w...

Page 110: ...Force FX Electrosurgical Generator C User s Guide Output power vs generator settings Low cut mode Pure Cut Mode Output power vs impedance for Pure cut 150W mode Output Power watts Generator Setting L...

Page 111: ...s Force FX Electrosurgical Generator C User s Guide 9 27 Output power vs impedance for Pure cut 300W mode Open circuit peak voltage vs output power for Pure cut mode Load Resistance ohms Output Power...

Page 112: ...orce FX Electrosurgical Generator C User s Guide Output power vs generator settings Pure cut mode Blend Cut Mode Output power vs impedance for Blend cut 100W mode Output Power watts Generator Setting...

Page 113: ...Force FX Electrosurgical Generator C User s Guide 9 29 Output power vs impedance for Blend cut 200W mode Open circuit peak voltage vs output power for Blend cut mode Load Resistance ohms Output Power...

Page 114: ...Output Power vs Resistance Graphs 9 30 Force FX Electrosurgical Generator C User s Guide Output power vs generator settings Blend cut mode Output Power watts Generator Setting...

Page 115: ...ns Force FX Electrosurgical Generator C User s Guide 9 31 Monopolar Coag Graphs These measurements were taken using short 0 5 meter leads Desiccate 1 Coag Mode Output power vs impedance for Desiccate...

Page 116: ...trosurgical Generator C User s Guide Output power vs impedance for Desiccate 1 coag 120W mode Open circuit peak voltage vs output power for Desiccate 1 coag mode Load Resistance ohms Output Power watt...

Page 117: ...e FX Electrosurgical Generator C User s Guide 9 33 Output power vs generator settings Desiccate 1 coag mode Desiccate 2 Coag Mode Output power vs impedance for Desiccate 2 coag 60W mode Output Power w...

Page 118: ...trosurgical Generator C User s Guide Output power vs impedance for Desiccate 2 coag 120W mode Open circuit peak voltage vs output power for Desiccate 2 coag mode Load Resistance ohms Output Power watt...

Page 119: ...e FX Electrosurgical Generator C User s Guide 9 35 Output power vs generator settings Desiccate 2 coag mode Desiccate 3 Coag Mode Output power vs impedance for Desiccate 3 coag 60W mode Output Power w...

Page 120: ...trosurgical Generator C User s Guide Output power vs impedance for Desiccate 3 coag 120W mode Open circuit peak voltage vs output power for Desiccate 3 coag mode Load Resistance ohms Output Power watt...

Page 121: ...Force FX Electrosurgical Generator C User s Guide 9 37 Output power vs generator settings Desiccate 3 coag mode Fulgurate Coag Mode Output power vs impedance Fulgurate coag 60W mode Output Power watts...

Page 122: ...orce FX Electrosurgical Generator C User s Guide Output power vs impedance Fulgurate coag 120W mode Output power vs peak voltage Fulgurate coag mode Output Power watts Load Resistance ohms Open Circui...

Page 123: ...ce FX Electrosurgical Generator C User s Guide 9 39 Output power vs generator settings Fulgurate coag mode LCF Fulgurate Coag Mode Output power vs impedance LCF Fulgurate coag 60W mode Output Power wa...

Page 124: ...rce FX Electrosurgical Generator C User s Guide Output power vs impedance LCF Fulgurate coag 120W mode Output power vs peak voltage LCF Fulgurate mode Load Resistance ohms Output Power watts Open Circ...

Page 125: ...tions Force FX Electrosurgical Generator C User s Guide 9 41 Output power vs generator settings LCF Fulgurate mode Spray Coag Mode Output power vs impedance Spray coag 60W mode Output Power watts Gene...

Page 126: ...42 Force FX Electrosurgical Generator C User s Guide Output power vs impedance Spray coag 120W mode Output power vs peak voltage Spray coag mode Load Resistance ohms Output Power watts Open Circuit Pe...

Page 127: ...utput Power vs Resistance Graphs Technical Specifications Force FX Electrosurgical Generator C User s Guide 9 43 Output power vs generator settings Spray coag mode Output Power watts Generator Setting...

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Page 130: ...s Corporation or its subsidiary Other brands are trademarks of a Covidien company One or more U S Patents 5 599 344 5 628 745 6 203 541 2011 Covidien Made in USA Printed in USA Covidien llc 15 Hampshi...

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