Covidien ClosureRFG Page 99 Operation Manual Download

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Part No. 1081160

COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive
Results for Life are U.S. and internationally registered trademarks of
Covidien AG. Other brands are trademarks of a Covidien company,
™* brands are trademarks of their respective owner.

For use under U.S. Pat. Nos. 8,321,019 and 8,636,729

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

1-800-962-9888 [T]

REV 08/2014

Summary of Contents for ClosureRFG

Page 1: ...Operation Manual ClosureRFG TM Radiofrequency Generator Covidien RFG3 Specs Provided by www AAATesters com...

Page 2: ...under shall 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...

Page 3: ...s internal business purpose in the operation of the Product or equipment purchased from other otherwise provided by COVIDIEN or its affiliates Except to the extent expressly authorized in this Softwar...

Page 4: ...mer has not cured all breaches of this License s limitations or restrictions Upon such termination Customer will immediately pay all undisputed fees outstanding cease use of all Software return or del...

Page 5: ...APPLY EVEN IF THE ABOVE STATED WARRANTY FAILS OF ITS ESSENTIAL PURPOSE SOME STATES DO NOT ALLOW LIMITATION OR EXCLUSION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES U S Government Rights The...

Page 6: ...ClosureRFG Radiofrequency Generator vii Software License parties hereby submit to the jurisdiction of the courts of the Commonwealth of Massachusetts...

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Page 8: ...ar Panel 1 5 Side Panels 1 6 General Safety Guidelines 1 6 Warnings and Safety Notices Setting Up the ClosureRFG Generator 1 7 Warnings and Safety Notices During RF Treatment 1 8 Unpacking and Inspect...

Page 9: ...4 3 Starting RF Treatment 4 4 Stopping RF Treatment 4 5 Chapter 5 Treatment Times Retain Total Treatment Timer Connecting a New Catheter 5 1 Treatment Time Reset Using the Same Catheter 5 2 Export RF...

Page 10: ...wer Output Charts 9 10 Chapter 10 Service Maintenance Maintenance 10 1 General Safety Guidelines 10 1 Fuse Replacement 10 2 Repairs and Returns 10 3 Return for Repair 10 3 Warranty 10 3 Cleaning and D...

Page 11: ...s for use with Covidien ClosureFast endovenous radiofrequency catheters and Covidien ClosureRFS endovenous radiofrequency stylets Throughout this manual the term catheter generally refers to both comp...

Page 12: ...as required for each geographical region The following RF treatment catheters Covidien ClosureRFS endovenous radiofrequency stylets with cord length of 8 ft Covidien ClosureFast 7 cm endovenous radio...

Page 13: ...n be set to be compatible with the treatment environment Alarm medium priority Three rapid mid frequency mixed tones Informational Single short high frequency pure tone RFS Advisory Two short informat...

Page 14: ...wing buttons and indicators AC Power Switch Illuminates when AC power is provided to the ClosureRFG generator RF Power Delivery Indicators Turns on when the ClosureRFG generator is first powered on an...

Page 15: ...ock these openings AC Power Cord Wrap When the ClosureRFG generator is not in use unplug the unit from the AC power source and wrap the cord around this wrap area Top Handle Best way to lift and carry...

Page 16: ...bration and repairs For qualified service personnel only Rubber Port Cover Provides a seal to limit liquid splashes getting into ports General Safety Guidelines The safe and effective use of RF energy...

Page 17: ...r surgical drapes Electrosurgical instruments that are activated or hot from use can cause a fire When not in use place electrosurgical instruments in a safety holster or safely away from patients the...

Page 18: ...eration is required during power interruptions the ClosureRFG generator must be powered from an uninterruptible power supply Warning Use the ClosureRFG generator only with Covidien ClosureFast endoven...

Page 19: ...f electrosurgery could result in neuromuscular stimulation resulting in patient injury Electrodes and probes for monitoring stimulating and imaging devices can provide paths for high frequency current...

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Page 21: ...e optimal use access all controls and view the operating screen Caution Do not stack any items on top of the ClosureRFG generator Doing so could damage the unit The ClosureRFG generator should not be...

Page 22: ...t if any of its surfaces appear to be cracked or damaged Do not plug the ClosureRFG generator into a damaged outlet Do not use a damaged AC power cord Do not use extension cords multiple portable outl...

Page 23: ...Version X X X Please Connect the Device Before inserting into body 1 2 The screen is divided into two areas with the data area above the message area The data area displays measurements temperature p...

Page 24: ...Undo button Undo to undo any changes made since opening the Generator Setup screen Press the Home button to accept the new settings and exit this screen Setting System Language EN FR DE IT NL ES SV T...

Page 25: ...30 31 29 30 25 26 27 28 2 To change the year press the left double arrow button to decrease or the right double arrow button to increase 3 To change the month press the left single arrow button to dec...

Page 26: ...dd yyyy 7 Press the row that displays the preferred date format Setting System Time 11 50 AM 1 Press the hours or minutes button to change the corresponding value A keypad is displayed MM 7 8 9 4 5 6...

Page 27: ...gs Time Adjusting Display Brightness 1 To change the brightness level Press the Brightness bar at the desired level or Press and drag the Slider button or Press the Dimmer or Brighter button 2 To retu...

Page 28: ...ormational tone for all other parameter conditions sounds During RF treatment the gauge related to that parameter turns gray An alarm message is displayed indicating the problem The operator can press...

Page 29: ...aligned with the red raised line on the catheter connector before inserting it Insert the connector end of a Covidien ClosureFast endovenous radiofrequency catheter or Covidien ClosureRFS endovenous...

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Page 31: ...icates current temperature of the catheter it is not intended to measure patient body temperature Treatment Time Indicates by counting down the amount of time RF power has been delivered during the cu...

Page 32: ...ges If a parameter is outside the advisory limits its gauge brightens within the red area or lights only the blue area a message is displayed and a tone is sounded ClosureFast gauges during treatment...

Page 33: ...eFast catheter Press Device Handle Button to Treat ClosureFast Total 00 00 m s 0 RF Cycle s Parameters of the catheter are checked before RF treatment is allowed If the temperature and impedance are a...

Page 34: ...or more information see Functional and Advisory Limits on page 2 8 Starting RF Treatment Note Review this section and General Safety Guidelines on page 10 1 before starting RF treatment Caution Do not...

Page 35: ...gress ClosureFast Total 00 00 m s 0 RF Cycle s 0 10s 1 2 3 2 RF delivery stops automatically when the 20 second RF treatment cycle is complete Warning If RF treatment does not stop disconnect the cath...

Page 36: ...Repeat step 3 until the procedure is completed Stopping RF Treatment RF treatment stops automatically since each cycle has a fixed time If it s found necessary to stop RF treatment before the timer fi...

Page 37: ...tton Starts RF treatment Changes to the blue RF Stop button when pressed Stylet temperature Indicates current temperature of the connected stylet it is not intended to measure patient body temperature...

Page 38: ...ges during treatment ClosureRFS 225 6 0w s 0 10 85 c 1 2 3 Illumination of the temperature gauge segments Blue Cool waiting for or at the beginning of a heating cycle below advisory limit during treat...

Page 39: ...en RF Start button Ready to treat with a ClosureRFS stylet ClosureRFS 35 c 225 0 0w s 0 00 Press RF Button to Treat Parameters of the stylet are checked before RF treatment is allowed If the temperatu...

Page 40: ...ghly read the stylet s instructions for use Confirm that the connected stylet matches the stylet type shown at the top of the Data Display area RF treatment can be stopped at any time if necessary by...

Page 41: ...Stop button on the screen to stop RF treatment a The RF Stop button changes from blue to the green RF Start button b The Treatment Timer 3 in the previous illustration displays the time that RF power...

Page 42: ...3 Move the stylet as directed in the stylet s instructions for use 4 Press the RF Stop button on the screen to pause RF treatment or when the procedure is finished Note The Treatment Timer displays th...

Page 43: ...sed on either the same patient patient site or a new patient patient site The screen shows this question Would you like to retain the total treatment timer value 1 Would you like to retain the total t...

Page 44: ...Timer Value button at the bottom of the screen The screen prompts for confirmation Would you like to retain the total treatment timer value 1 Would you like to retain the total treatment timer value...

Page 45: ...ice should receive an explanation of the ESD warning symbol and training in ESD precautionary procedures This includes clinical biomedical engineering and health care staff At minimum this training sh...

Page 46: ...st record is at the top of page 1 When entering this screen all entries not exported so far are already selected 4 Perform one of the following actions a If the selection is correct go to step 5 below...

Page 47: ...2 14 2012 09 23 16 32 RFS 5 12 1 SD Cards The SD card stores ClosureRFG radiofrequency generator treatment data for troubleshooting these records are not saved in the ClosureRFG generator if the SD ca...

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Page 49: ...one required High Power Advisory Display Advisory Power high Sound Informational Tone None required High Impedance Functional Advisory Display Advisory Impedance high Check Connection Sound Informatio...

Page 50: ...Advisory Clear any advisory message Display Advisory Power high Sound Informational Tone None required Low Power And Low Impedance Advisory Clear any advisory message Display Advisory Power low Sound...

Page 51: ...ledgement High Impedance Functional Limit Display Treatment Halted Impedance high Please press to continue Sound Informational Tone Wait for User Acknowledgement User acknowledgement Low Impedance Fun...

Page 52: ...Y W Press Device Handle Button to Treat Sound Informational Tone None required Terminate ClosureFast Complete Cycle Press Device Handle button to Treat RF cycle completed at mm ss X C Y W Z Total Tre...

Page 53: ...nds Output RF ramp up tone None required Confirm Discard Display Would you like to retain the total treatment timer value Wait for User Acknowledgement User acknowledgement Error Log Corruption Displa...

Page 54: ...t Medium High Temperature Functional Limit Alarm Priority Sound Pressure Priority Sound Pressure Level Medium 45 dB Message Priority Priority Message 1 Highest Alarm Message 2 Advisory Message 3 Infor...

Page 55: ...pected state Cycle system power and allow the POST testing to complete If the system does not respond and or the same error code is displayed contact Covidien customer service 2 Unexpected event 3 A p...

Page 56: ...n on the About tab of the Settings menu If the serial numbers do not match and or the same error code is displayed contact Covidien customer service 28 The inserted USB device is not correctly formatt...

Page 57: ...em power If the system does not respond and or the same error code is displayed contact Covidien customer service 37 The temperature of the ClosureRFG generator is above the specified operating temper...

Page 58: ...insert Cycle system power and allow POST to complete If the issue persists reformat the USB device on your PC by right clicking the device and selecting format The device must be formatted to FAT32 If...

Page 59: ...insert a known working catheter and cycle system power If the system does not respond and or the same error code is displayed contact Covidien customer service 102 Temperature is too high 103 Impedan...

Page 60: ...110 Temperature and Power are too low 111 Temperature is too high and Power is too low 112 Impedance and Power are too low 113 Temperature Impedance and Power are too low 114 Temperature is too high...

Page 61: ...oo low 205 Power is too high 206 Power is too low 314 Task took too long to complete Cycle system power and allow the POST to complete If the system does not respond and or the same error code is disp...

Page 62: ...ID Calibration Load Cycle system power and allow the POST to complete If the error persists insert a known working catheter Cycle system power again If the system does not respond and or the same erro...

Page 63: ...stem power cycle and allow the POST to complete If the system does not respond and or the same error code is displayed contact Covidien customer service 471 The ClosureRFG generator Calibration Load R...

Page 64: ...has failed 481 The frequency source of the ClosureRFG generator is not correct 482 The ClosureRFG generator has too much offset in the catheter ID circuit Cycle system power and allow the POST to comp...

Page 65: ...igns of physical damage Check the power cord Replace the power cord if you find exposed wires cracks frayed insulation or a damaged connector Verify that the wall outlet is supplying power Refer to Ch...

Page 66: ...ry Temperature low Inadequate vessel exsanguination Verify that the catheter is properly positioned Check for flow and employ or improve compression techniques as necessary Saline in catheter connecto...

Page 67: ...of saline If present contact Covidien Customer Service Caution Take care never to plug a wet catheter connector into the receptacle as this may damage the ClosureRFG generator Short circuit Replace ca...

Page 68: ...n circuit Check stylet connection disconnect and then reconnect Replace stylet Power high Too much blood flow Pullback rate too fast Check and improve exsanguination Verify proper pullback rate Temper...

Page 69: ...fter acknowledgement Recoverable errors may require the operator to respond to an error message or make a clinical decision Some errors require pressing the Green Check Mark button after which the Clo...

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Page 71: ...external defibrillator while the RF catheter is in use Electrical ClosureRFG Generator Operates from an AC power source ranging from 100 V to 240 VAC 50 Hz to 60 Hz 5A Includes a DIN 42801 compatible...

Page 72: ...nd 1060 hPa Conditions for Operating the ClosureRFG Generator 50 F 10 C 104 F 40 C Temperature between 10 C and 40 C 90 10 Relative humidity non condensing between 10 and 90 700 hPa 1060 hPa Ambient a...

Page 73: ...s designed to limit the output control depending on the accessory being used For example ClosureFast endovenous radiofrequency ablation catheter 7 cm is limited to 40 W maximum ClosureFast endovenous...

Page 74: ...ed time of RF delivery The ClosureRFG generator also interfaces with a sensor in the catheter to provide a continuous display of measured patient temperature prior to and during RF delivery The major...

Page 75: ...e UI assembly It supplies 12 volts to the UI assembly and provides access to all the important signals coming from it The I O board provides the communication interface between the RF board and UI ass...

Page 76: ...with air oxygen or nitrous oxide Do not operate the ClosureRFG generator in contact with flammable materials chemicals or substances The ClosureRFG radiofrequency generator should be used only with a...

Page 77: ...r is not in use unplug it from the AC power outlet and wrap the cord around the AC power cord wrap area Do not carry or lift the ClosureRFG generator by the AC power cord or catheter cables The chemic...

Page 78: ...Watts Power ClosureFast catheters RF power icon Treatment Status RF ready to start green Options button Opens the Settings screen ClosureFast catheters RF power icon Treatment Status RF is powered on...

Page 79: ...ns for use Equipotentiality RX only The output is floating with respect to ground This side up Fuses Fragile Dangerous voltage Do not dispose in trash SD Card USB Device Storage device slots Explosion...

Page 80: ...ndovenous radiofrequency ablation RFA catheter 7 cm Defibrillation proof type CF applied part 90 10 4 F 104 F 20 C 40 C to Humidity limitations operation 60 10 104 F 158 F 40 C 70 C to Humidity limita...

Page 81: ...put Control Settings at 200 2 3 1 Power output watts Power output control settings watts ClosureFast endovenous radiofrequency ablation RFA catheter 3 cm Power Output vs Output Control Settings at 200...

Page 82: ...Output Full Power Output Control Settings 2 3 1 4 5 Power output watts Impedance ohms ClosureFast endovenous radiofrequency ablation RFA catheter 7 cm ClosureFast endovenous radiofrequency ablation R...

Page 83: ...General Safety Guidelines on page 1 6 In addition The AC power switch on the front panel serves as the means of disconnection from supply mains This switch also isolates the ClosureRFG generator elect...

Page 84: ...osureRFG radiofrequency generator s AC power cord from the AC power inlet 1 Fuse Replacement 1 2 3 4 5 2 Insert a small blade screwdriver into the small slot located on the left side of the holder 2 a...

Page 85: ...ien technician voids the warranty Cleaning and Disinfecting The ClosureRFG radiofrequency generator requires no scheduled maintenance other than cleaning external surfaces Cleaning should be performed...

Page 86: ...0 25 Sodium Hypochlorite Disinfecting wipes or pads that contain only Sodium Hypochlorite are acceptable IPA in water 70 30 All surfaces including the bottom side of the ClosureRFG generator and any s...

Page 87: ...edge of the applicable electrical safety standards which pertain to these tests Covidien assumes no responsibility for damage to the unit due to improper application of the following tests If in doubt...

Page 88: ...s 240 V Parameter Conditions Passing Input Voltage Rated line 10 264 V Line Cord Resistance N A 100 m 25 A chassis cord gnd 10 seconds 100 m Earth Leakage Power Norm GND OPEN 500 A Earth Leakage Power...

Page 89: ...med Test Cable to access patient connections Short the electrodes and thermocouple wires together for testing 4 For the 25 A test connect the ROD L leads to the chassis ground lug and to the ground pi...

Page 90: ...agnetic compatibility EMC Part 4 2 Testing and measurement techniques Electrostatic discharge immunity test IEC 61000 4 3 2010 Electromagnetic compatibility EMC Part 4 3 Testing and measurement techni...

Page 91: ...nvironment Emissions Test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 2 The ClosureRFG generator must emit electromagnetic energy in order to perform its intended funct...

Page 92: ...ion in power occurs it may be necessary to reset the unit by disconnecting and reconnecting the catheter Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line...

Page 93: ...3 V m80 MHz to 2 5 GHz 3 VRMS NOTE UT is the a c mains voltage prior to application of the test level NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not a...

Page 94: ...wer not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of...

Page 95: ...here are no internal adjustments to the RF power generator Covidien has created a Biomedical Department Inspection Procedure for the testing of the ClosureRFG radiofrequency generator This procedure o...

Page 96: ...SU Analyzer the measurement tolerances of the ESU Analyzer for a given test must be added to the tolerances listed for the ClosureRFG generator Power Delivery Verification This test verifies the abili...

Page 97: ...ce RF power time or a combination of these outside of which RF delivery will not start or stops immediately Impedance The effective resistance of the Covidien ClosureFast endovenous radiofrequency cat...

Page 98: ...me and cycles to the current open record This is used when a catheter is reconnected and the same site is to be further treated Retain continues to add cycles and time to an open record RF Radiofreque...

Page 99: ...their respective owner For use under U S Pat Nos 8 321 019 and 8 636 729 2014 Covidien Made in USA Printed in USA Covidien llc 15 Hampshire Street Mansfield MA 02048 USA Covidien Ireland Limited IDA B...

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