Covidien ClosureRFG Operation Manual
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Covidien ClosureRFG Operation Manual

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

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Summary of Contents for Covidien ClosureRFG

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

  • Page 2: Limited Warranty

    This limited warranty does not apply to any Product, or part thereof, which has been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.

  • Page 3: Software License

    Software License The Product includes proprietary software and computer programs copyrighted and owned by Covidien LP. Covidien LP retains all right, title and interest to the proprietary software, computer programs, and all portions thereof, and any associated documentation (collectively, the “Software”) provided to Customers as may be installed in the Products and equipment addressed herein or provided separately, and it has the sole right to grant license to the Software hereunder.
  • Page 4 Software. COVIDIEN may, in its sole discretion, undertake to incorporate such changes and distribute the Software so modified to all or any of COVIDIEN's customers. All such error corrections, bug fixes, patches, updates or other modifications provided to COVIDIEN shall be the sole property of COVIDIEN.
  • Page 5 Agreement; (vi) Products or equipment with their original manufacturer’s serial numbers altered, defaced or deleted; (vii) Products or equipment that have been altered, serviced or modified by a party other than COVIDIEN or an authorized COVIDIEN provider; or (viii) Software that has been subjected to abnormal physical or electrical stress, misuse, negligence or accident by Customer or a third party.
  • Page 6 Software License parties hereby submit to the jurisdiction of the courts of the Commonwealth of Massachusetts. ClosureRFG Radiofrequency Generator...

  • Page 8: Table Of Contents

    Warnings and Safety Notices: Setting Up the ClosureRFG Generator......1-7 Warnings and Safety Notices: During RF Treatment..1-8 Unpacking and Inspection of Components .
  • Page 9 Equipment Type ........9-1 Electrical: ClosureRFG Generator ....9-1 100-120 VAC, 5 A .
  • Page 10 Generator........9-2 Conditions for Operating the ClosureRFG Generator ..9-2 RF Power Delivery Performance .

  • Page 11: Chapter 1. Overview & General Features

    Overview & General Features Overview Caution U.S. federal law restricts the ClosureRFG generator to sale by or on the order of a physician. Important Prior to using the Covidien ClosureRFG radiofrequency generator, read this manual and review the warnings and cautions in it for important safety information.

  • Page 12: Intended Use

    • A USB drive for data export • An SD data card to store generator treatment data (used for troubleshooting) • A calibration test cable for connecting the ClosureRFG generator to a calibrated test load ClosureRFG Radiofrequency Generator...

  • Page 13: Visual Indicators

    • RF Power: Two software-controlled LEDs in the upper corners of the front illuminate blue when RF power is being delivered (RF power-delivery indicators) • AC Power Switch: Indicates when the ClosureRFG generator is turned on Audible Indicators The ClosureRFG generator has audible indicators designed to alert the operator. Sound levels of alarm tones can be set to be compatible with the treatment environment.

  • Page 14: Front Panel

    START The ClosureRFG radiofrequency generator front panel has the following 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, and when RF power is being delivered.

  • Page 15: Rear Panel

    Vent Openings: Provide cooling air to the electronics. Do not block 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.

  • Page 16: Side Panels

    (or the top handle) while lifting or carrying the unit. Caution Be careful not to exert force to an attached USB device when picking up the ClosureRFG generator by the side handles. Vent Openings: Cooling air for the electronics.

  • Page 17: Warnings And Safety Notices: Setting Up The Closurerfg Generator

    General Safety Guidelines The ClosureRFG generator is for prescription use only. It is intended for use only by trained clinicians (operators) in a hospital or clinical environment. The ClosureRFG generator contains no operator-serviceable parts. It must be returned to the factory for service.

  • Page 18: Warnings And Safety Notices: During Rf Treatment

    Avoid covering the speaker openings, to allow the operator to detect auditory tones. Ensure the AC power switch on the front is accessible so that the ClosureRFG generator can be turned on and off.

  • Page 19: Unpacking And Inspection Of Components

    ClosureRFG generator should be observed to verify normal operation in the configuration in which it will be used. Do not plug a wet catheter connector into a receptacle as it may damage the ClosureRFG generator.

  • Page 21: Chapter 2. Closurerfg Generator Setup

    Caution Do not stack any items on top of the ClosureRFG generator. Doing so could damage the unit. The ClosureRFG generator should not be used adjacent to other equipment. If stacked or adjacent use is necessary, the ClosureRFG generator should be observed to verify normal operation in the configuration in which it is used.

  • Page 22: Applying Ac Power

    Caution Do not plug the ClosureRFG generator into the AC power outlet 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.

  • Page 23: Standby Screen

    [e.g., Please Connect the Device (Before inserting into body)]. Note: To ensure safe RF delivery, it is important to be familiar with how the ClosureRFG generator works, how to change desired settings, and how to interpret displays.

  • Page 24: Setting System Language

    Press the box for the language of choice. The selected language is shown in the text box at the right of the selection bar. To reject the language change, press the Undo button. Undo ClosureRFG Radiofrequency Generator...

  • Page 25: Setting System Date

    5. Press the Green Check Mark button to store the date and return to the Generator Setup screen. Press the Red X button to return the date to the previous settings and return to the Generator Setup screen. ClosureRFG Radiofrequency Generator...

  • Page 26: Setting System Time

    1. Press the hours or minutes button to change the corresponding value. A keypad is displayed. 2. Press the number buttons to set the hours or minutes. 3. Press the Green Check Mark button to save the entry, or Red X button to leave the pad without changes. ClosureRFG Radiofrequency Generator...

  • Page 27: Adjusting Display Brightness

    Press the Sound Level bar at the desired level, or • Press and drag the Slider button, or • Press the Softer or Louder button. 2. To return the loudness to the previous setting, press the Undo button. ClosureRFG Radiofrequency Generator...

  • Page 28: Total Treatment Summary Readout

    Caution Operation of the ClosureRFG generator during an advisory limits warning may cause suboptimal RF treatment. The ClosureRFG generator may not allow treatment to continue if the cause of the advisory message is allowed to persist. • Advisory messages automatically clear when conditions causing the messages are gone.

  • Page 29: Connecting A Catheter

    Important The red mark on the ClosureRFG generator case must be 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 radiofrequency stylet into the receptacle on the front of the ClosureRFG generator.

  • Page 31: Chapter 3. Covidien Closurefast Endovenous Radiofrequency Catheter Treatment

    20 seconds. Catheter Identifier: “ClosureFast” is displayed. RF Ready Icons: Indicates whether the ClosureRFG radiofrequency generator is ready to start RF treatment. When dark or gray, RF power is disabled due to a limit violation. When illuminated brighter, RF power is ready to be delivered to the catheter.

  • Page 32: Closurefast Catheter Gauges

    • Blue-Green: Within normal range after initial heating • Red: Temperature above advisory or functional limit The illumination of the power gauge segments: • Blue: Low but within limits • Blue-Green: Within normal range • Red: Power above advisory or functional limit ClosureRFG Radiofrequency Generator...

  • Page 33: Closurefast Catheter Rf Treatment - Ready To Treat

    Note: For more information about these Limits, see Functional and Advisory Limits on page 2-8. ClosureFast Catheter RF Treatment – Ready to Treat The connected ClosureFast catheter displays the following screen. The ClosureRFG radiofrequency generator is ready to start treatment, as indicated by the green RF-ready icon.

  • Page 34: Starting Rf Treatment

    RF treatment can be stopped at any time, if necessary, by pressing the catheter handle button. Note: The Treatment Summary, which is the accumulated time and cycles that the ClosureRFG radiofrequency generator applies power, can be displayed in the data area. Select this option in the Generator Setup screen.
  • Page 35 When the setpoint is reached, the RF-on tone sounds every few seconds. e. The ClosureRFG generator holds temperature at 120° C until the RF treatment time of 20 seconds has completed. ClosureFast RF treatment in progress...

  • Page 36: Stopping Rf Treatment

    RF treatment before the timer finishes, press the catheter handle button. Note: See Treatment Time Reset—Using the Same Catheter on page 5-2 for an explanation of the treatment record. Note: See Export—RF Treatment Data Storage on page 5-3 for steps to export the treatment history. ClosureRFG Radiofrequency Generator...

  • Page 37: Chapter 4. Covidien Closurerfs Endovenous Radiofrequency Stylet Treatment

    Chapter 4 Covidien ClosureRFS Endovenous Radiofrequency Stylet Treatment Ready-to-Treat Screen ClosureRFS ready to treat screen ClosureRFS 0:00 Ω Whenever a ClosureRFS stylet is connected, this screen is present: RF Start button: Starts RF treatment. Changes to the blue RF Stop button when pressed.

  • Page 38: Closurerfs Stylet Gauges

    • Red-yellow (low end): Below advisory or functional limit • Blue-Green: Within normal range to advisory • Red: Above advisory or functional limit Illumination of the Power gauge segments: • Blue and Blue-Green: Within normal range to advisory • Red: Above advisory or functional limit ClosureRFG Radiofrequency Generator...

  • Page 39: Closurerfs Stylet Rf Treatment-Ready To Treat

    Note: For more information about these limits, see Functional and Advisory Limits on page 4-3. ClosureRFS Stylet RF Treatment—Ready to Treat The connected ClosureFast stylet displays the following. The ClosureRFG radiofrequency generator is ready to start treatment, as shown by the green RF Start button. Ready to treat with a ClosureRFS stylet...

  • Page 40: Starting Rf Treatment

    When the setpoint is reached, the RF ON tone sounds every few seconds. e. The ClosureRFG radiofrequency generator holds temperature at 85° C until treatment is stopped by pressing the RF Stop button. ClosureRFG Radiofrequency Generator...

  • Page 41: Stopping Rf Treatment

    The screen displays “Press RF Button to Treat.” Important Do this next step only if treatment was stopped with the intention to continue. The displayed cycle time will reset to zero and the total treatment time will continue to accumulate with further treatment. ClosureRFG Radiofrequency Generator...
  • Page 42 Note: The Treatment Timer displays the time for only this cycle. 5. Repeat steps 2-4 as needed. 6. When finished with the procedure, press the Treatment History button to obtain the total treatment time, which will be in the first data record on page 1. ClosureRFG Radiofrequency Generator...

  • Page 43: Chapter 5. Treatment Times

    Would you like to retain the total treatment timer value? • Same patient or site: To continue adding to the previous timer value, press the Green Check Mark button. The ClosureRFG generator will behave as if the catheter had never been unplugged.

  • Page 44: Treatment Time Reset-Using The Same Catheter

    Press the Red X button to not retain the Treatment Timer, and start a new treatment record. This will perform the reset. Note: Cycling power on ClosureRFG generator will also reset the timer and close the current record. ClosureRFG Radiofrequency Generator...

  • Page 45: Export-Rf Treatment Data Storage

    ClosureRFG radiofrequency generator (the ground lug on the back). Alternatively, use an ESD wrist strap to bond to the ClosureRFG generator’s ground lug or to a known earth ground. This is important to avoid electrostatic discharge damage to the memory device.
  • Page 46 Note: If the USB is full, or no records are selected, a message states “No records exported.” Insert a different USB card or select records to export. 6. Remove the USB device 7. Insert another USB device, or attach the rubber port cover. ClosureRFG Radiofrequency Generator...

  • Page 47: Sd Cards

    Covidien Service Representative. Important The SD card should be left in the ClosureRFG generator at all times. However, if necessary to remove/replace the SD Card: 1. Use a tool, such as a small screwdriver, to carefully pry off the rubber port cover on the left side panel.

  • Page 49: Chapter 6. Messages, Tones, And Responses

    Low Power And High Clear any advisory message. Display: None required Temperature Advisory “Advisory: Temperature high, power low” Sound: Informational Tone. High Impedance And High Clear any advisory message. Display: None required Temperature Advisory “Advisory: Temperature high” Sound: Informational Tone. ClosureRFG Radiofrequency Generator...
  • Page 50 “Advisory: Temperature low. Power Impedance Advisory high. Impedance high” Sound: Informational Tone. High Power High Clear any advisory message. Display: None required Temperature And Low “Advisory: Temperature high. Power Impedance Advisory high. Impedance low” Sound: Informational Tone. ClosureRFG Radiofrequency Generator...
  • Page 51 Please press  to acknowledgement continue.” message. Sound: Informational Tone. Wait for User Acknowledgement. Advisory Catheter Broken Display: “The connected device is User broken. Please connect another device.” acknowledgement. Sound: Informational Tone. Wait for Replace catheter. User Acknowledgement. ClosureRFG Radiofrequency Generator...
  • Page 52 Display: “N records selected for export.” None required Records Selected Export In Process Display: “Exporting in process, do not None required remove USB device.” Treatment Summary Display: “Treatment summary data Remove USB device Export Completed exported. Ok to remove USB device.” ClosureRFG Radiofrequency Generator...

  • Page 53: Audible Signals

    Please connect another device.” Audible Signals The ClosureRFG radiofrequency generator produces a audible signal for out-of-limit conditions based on the power, temperature, and impedance measurements. During multiple message or tone conditions, the message or tone with the highest priority takes precedence, as shown in the following two tables.
  • Page 54 Advisory Message Informational Message Tone Priority Priority Tone 1 (Highest) Button Acknowledge Tone Invalid Tone Alarm Tone RF Stop Tone Informational Tone RF Advisory Tone RF Start Tone RF On Tone RF Pullback Pause Tone Power On Tone ClosureRFG Radiofrequency Generator...

  • Page 55: Chapter 7. Error Codes

    Chapter 7 Error Codes If an error occurs, the ClosureRFG radiofrequency generator displays an error code. An error is one of two types: unrecoverable or recoverable. • Unrecoverable errors stop the ClosureRFG generator from functioning and require the operator to acknowledge the condition. Once the operator presses the green check-mark, the ClosureRFG generator (itself or with assistance) cycles power to continue.
  • Page 56 “format” on your PC. The device must be The ClosureRFG formatted to FAT32. If the system does not respond and/or radiofrequency the same error code is displayed, contact Covidien customer generator is unable to service. write data to the USB device.
  • Page 57 Reformat the USB device by right clicking the device and selecting “format” on your PC. The device must be formatted to FAT32. If the system does not respond and/or the same error code is displayed, contact Covidien customer service. A UIC Software Task Cycle system power and allow the system POST to complete.
  • Page 58 SW. Upgrade the system from the “About” tab. wrong with the Cycle system power again. If the system does not respond software. and/or the same error code is displayed, contact Covidien customer service. This error indicates Remove the USB device, clear the data on the device and that error log was reinsert.
  • Page 59 Cycle system power and allow the POST to complete. If the low. error persists, insert a known, working catheter and cycle system power. If the system does not respond and/or the Temperature is too same error code is displayed, contact Covidien customer high. service. Impedance is too low. Temperature and Impedance are too low.
  • Page 60 Temperature is too low system power. If the system does not respond and/or the and Impedance is too same error code is displayed, contact Covidien customer high. service. Temperature and Impedance are too high.
  • Page 61 Cycle system power and allow the POST to complete. If the safety limit. error persists, insert a known, working catheter. Cycle system power again. If the system does not respond and/or The catheter power the same error code is displayed, contact Covidien customer exceeded the service. ClosureRFG radiofrequency generator Power Alarm Limit.
  • Page 62 Cycle detected. system power again. If the system does not respond and/or the same error code is displayed, contact Covidien customer service. Generator ROM Cycle system power cycle and allow the POST to complete.
  • Page 63 SW. Upgrade the system using the “About” tab. compatible with the Cycle system power again. If the system does not respond HW revision. and/or the same error code is displayed, contact Covidien customer service. The ClosureRFG Cycle system power cycle and allow the POST to complete.
  • Page 64 SW. Upgrade the system using the “About” tab. able to control the Cycle system power again. If the system does not respond isolated power supply and/or the same error code is displayed, contact Covidien enable. customer service. RF Amplifier cannot be Cycle system power cycle and allow the POST to complete.

  • Page 65: Chapter 8. Troubleshooting

    During RF treatment, the ClosureRFG radiofrequency generator monitors the catheter’s parameters (temperature, impedance, and RF power). Should one of these measurements be too high or too low, the ClosureRFG generator may stop RF treatment, sound an alarm, display an alarm message, and/or and flash this icon: The following tables describe some situations that the operator might encounter.
  • Page 66 Check for presence of saline. If present, contact connector Covidien Customer Service. (Caution: Take care never to plug a wet catheter connector into the receptacle, as this may damage the ClosureRFG generator). Catheter, cable, or Check all connections, cable, and the catheter for connector is visible damage.
  • Page 67 Check for presence of saline. If present, contact (not displayed) connector and/or Covidien Customer Service. (Caution: Take care receptacle never to plug a wet catheter connector into the receptacle, as this may damage the ClosureRFG generator). Short circuit Replace catheter. Impedance high Open circuit...
  • Page 68 Check for presence of saline. If present, contact connector and/or Covidien Customer Service. (Caution: Take care receptacle never to plug a wet catheter connector into the receptacle, as this may damage the ClosureRFG radiofrequency generator.) Short circuit Replace stylet. Impedance high...

  • Page 69: Error Codes-Generator

    Error Codes—Generator If a ClosureRFG radiofrequency generator system error occurs, the screen displays an error code. An error is one of two types: unrecoverable or recoverable. • Unrecoverable errors stop the ClosureRFG generator and the ClosureRFG generator must be power cycled –...

  • Page 71: Chapter 9. Technical Specifications

    For ClosureRFG radiofrequency generator repairs or returns, call the Covidien Customer Service Department. The ClosureRFG generator may be returned to the factory. The Class I ClosureRFG radiofrequency generator is designed to work with Type CF, Defibrillator-Proof RF catheters. The ClosureRFG generator is designed to withstand an application of an external defibrillator while the RF catheter is in use.

  • Page 72: 220-240 Vac, 5 A

    220-240 VAC, 5 A • Cable: H05VVF3G1.0 VDE, maximum length 10 ft. (3 m) • Plug: minimum 6 A - 240 VAC • Unit receptacle: IEC female, minimum 6 A - 240 VAC Conditions for Transporting and Storing the ClosureRFG Generator 158°F 70°C •...

  • Page 73: Maximum Output

    ClosureFast endovenous radiofrequency ablation catheter 7 cm, 45 - 300 ohms for ClosureFast endovenous radiofrequency ablation catheter 3 cm and 110 - 400 ohms for ClosureRFS endovenous radiofrequency stylet. Duty Cycle Mode Duty Cycle ClosureFast 60 s on / 2 s off ClosureRFS Continuous ClosureRFG Radiofrequency Generator...

  • Page 74: System Overview

    It measures and displays RF output power, load impedance (ClosureRFS only), and elapsed 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.
  • Page 75 System Overview List of Circuit Boards The ClosureRFG radiofrequency generator consists of six main PCBs which make up the five subsystems: • UI Board (contains UI Processor and LCD Touch Screen electronics) • I\O Board • RF Board • AC Power Supply •...

  • Page 76: General Description And Operating Conditions

    General Description and Operating Conditions Warning Do not operate the ClosureRFG generator in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. Do not operate the ClosureRFG generator in contact with flammable materials, chemicals, or substances.

  • Page 77: Environmental Conditions

    Ambient atmospheric pressure between 500 hPA and 1060 hPa. 500 hPa When the ClosureRFG generator 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.

  • Page 78: Common Symbols And Icons

    There are numerous warning and caution symbols, icons, and buttons (when pressed, cause an action) used throughout this manual by the ClosureRFG generator. The operator should be familiar with them and their meanings. Symbols Used by the ClosureRFG Generator...
  • Page 79 Common Symbols and Icons Symbols Used on the ClosureRFG Generator and Packaging Caution: Consult Alternating Current accompanying documents Consult instructions for use Equipotentiality The output is floating with RX only respect to ground This side up Fuses Fragile Dangerous voltage...

  • Page 80: Power Output Charts

    Not made with natural rubber limitations, storage latex 500 hPa Power Output Charts Power Output vs. Output Control Settings at 200 Power output (watts) Power output control settings (watts) ClosureFast endovenous radiofrequency ablation (RFA) catheter 7 cm 9-10 ClosureRFG Radiofrequency Generator...
  • Page 81 Power output (watts) Power output control settings (watts) ClosureFast endovenous radiofrequency ablation (RFA) catheter 3 cm Power Output vs. Output Control Settings at 200 Power output (watts) Power output control settings (watts) ClosureRFS endovenous radiofrequency stylet 9-11 ClosureRFG Radiofrequency Generator...
  • Page 82 Maximum Power Output - Full Power Output Control Settings Power output (watts) Impedance (ohms) ClosureFast endovenous radiofrequency ablation (RFA) catheter 7 cm ClosureFast endovenous radiofrequency ablation (RFA) catheter 3 cm ClosureRFS endovenous radiofrequency ablation (RFA) stylet 9-12 ClosureRFG Radiofrequency Generator...

  • Page 83: Chapter 10. Service & Maintenance

    40° C and 70° C and non-condensing relative humidity between 10% and 60%. 104°F 40°C Operate the ClosureRFG generator at temperatures between 10 º C and 40 º C 50°F 10°C and in non-condensing relative humidity between 10% and 90%.

  • Page 84: Fuse Replacement

    In the event of a fuse failure, replace the fuses using the following procedure, as shown: Caution Fuses must be replaced with 5 A/250 V, 5x20 mm fuses. Using other fuses might damage the unit. 1. Disconnect the ClosureRFG radiofrequency generator’s AC power cord from the AC power inlet (1). Fuse Replacement 2.

  • Page 85: Repairs And Returns

    Service Department. The ClosureRFG generator may be returned to the factory. Warning Do not remove the cover of the ClosureRFG generator, as there is a potential for electrical shock. Return for Repair Call Customer Service for an Authorized Return Number and shipping instructions:...

  • Page 86: Disposal

    • IPA in water, 70/30. All surfaces, including the bottom side of the ClosureRFG generator and any surface on which it is placed, must be cleaned of any residues. The ClosureRFG generator cannot be sterilized and must not enter a sterile surgical field.

  • Page 87: Chapter 11. Electrical Safety Tests

    Covidien assumes no responsibility for damage to the unit due to improper application of the following tests. If in doubt, consult the Safety Analyzer User’s Manual or Covidien prior to conducting the following tests. Electrical Safety Tests 220-240 V Warning High Voltage Do not touch the equipment during the isolation tests.
  • Page 88 Power Normal, GND OPEN < 10 μA Source Leakage, Applied Part Power Reversed, GND OPEN < 10 μA Iso Test, Applied Part Power Normal < 10 μA Iso Test, Applied Part Power Reversed < 10 μA 11-2 ClosureRFG Radiofrequency Generator...

  • Page 89: Electrical Safety Tests 110-120 V

    1. Use the variable autotransformer and the DVM to set the line voltage to 132 V. Do not exceed 140 V. 2. Plug the line cord of the ClosureRFG radiofrequency generator into the leakage tester for all tests. 3. For source leakage and isolation tests, use the Biomed Test Cable to access patient connections.

  • Page 90: Electromagnetic Compliance (Emc)

    IEC 61000-4-8:2009, Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test IEC 61000-4-11:2004, Electromagnetic compatibility (EMC) - Part 4-11: Testing and measuring techniques - Voltage dips, short interruptions and voltage variations immunity tests 11-4 ClosureRFG Radiofrequency Generator...
  • Page 91 Guidance and manufacturer’s declaration - electromagnetic emissions The ClosureRFG radiofrequency generator is intended for use in the electromagnetic environment specified below. The customer or the user of the ClosureRFG generator should assure that it is used in such an environment.
  • Page 92 Guidance and manufacturer’s declaration - electromagnetic immunity The ClosureRFG radiofrequency generator is intended for use in the electromagnetic environment specified below. The customer or the user of the ClosureRFG generator should assure that it is used in such an environment.
  • Page 93 80 MHz communications equipment should be used no closer to any part of the Radiated RF IEC 3 V/m80 MHz ClosureRFG radiofrequency generator, 61000-4-3 to 2,5 GHz including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 94: Electromagnetic Interference (Emi)

    ClosureRFG generator The ClosureRFG generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ClosureRFG generator can help prevent electromagnetic interference by maintaining a minimum distance between...

  • Page 95: Biomedical Department Inspection And Power Output Test

    EMI may be conducted through the AC power lines. Restrict the use of this equipment in the vicinity of the ClosureRFG generator. If interference affects other equipment in the treatment area, move the other equipment or the ClosureRFG generator to a different location.

  • Page 96: Test Method

    ESU analyzer. 4. Turn off main power to the ClosureRFG generator. Remove the Test Cable and AC power cord from the ClosureRFG generator. 5. In assessing the functionality of the ClosureRFG generator with any external...

  • Page 97: Chapter 12. Glossary Of Terms

    Catheter - An approved Covidien RF delivery or RF powered accessory that can be attached to the ClosureRFG radiofrequency generator. Default - A value for a setting that is assigned automatically by the ClosureRFG generator. Default values remain in effect unless altered in the ClosureRFG Generator Settings screen.
  • Page 98 (CLF or RFS), the treatment duration, and the number of cycles. A record is ‘open’ during a treatment for one or several cycles, and ‘closed’ when the ClosureRFG radiofrequency generator is power cycled, a different catheter type is connected, a ‘Reset’ is done, or a ‘Retain’ is not accepted.
  • Page 99 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...

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