ClosureRFG Operation Manual Rev Aug 2014

Operation Manual

ClosureRFG

TM

Radiofrequency Generator

Part Number: 1081160

Preface

Preface Conventions Used in This Guide Warning Warning indicates a hazardous situation that could result in death, serious injury, permanent impairment (including medical or surgical intervention to prevent it), or a situation that results in moderate or transient harm to a body structure.

Caution Important precautions that describe unsafe conditions for the patient or operator, including minor complications that do not meet the definition of a Warning, or that could cause equipment damage or product malfunction. Important Information on the use of the ClosureRFGTM radiofrequency generator.

Note - Additional helpful information

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ClosureRFG Radiofrequency Generator

Limited Warranty

Limited Warranty Covidien warrants the covered Product listed below to be free from defects in material and workmanship for normal use and service for the period(s) set forth below. Covidien’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 authorized distributor) within the applicable time period shown below after delivery of the Product to the original purchaser, and which examination discloses, to Covidien’s satisfaction, that the Product is defective. 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. The warranty period for this Covidien Product is as follows: ClosureRFGTM Radiofrequency Generator

One year from date of shipping

Notwithstanding any other provision herein or in any other document or communication, Covidien’s liability with respect to this limited warranty and the Products sold hereunder 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). There are no warranties which extend beyond the terms hereof. Covidien disclaims any liability hereunder or elsewhere in connection with the sale of Products and for any form of indirect, tort, or consequential damages. This limited warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the Commonwealth of Massachusetts, USA. The sole forum for resolving disputes arising under or relating in any way to this limited warranty is the District Court of the County of Suffolk, Commonwealth of Massachusetts, USA. Covidien reserves the 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 OBLIGATION TO REPAIR OR REPLACE A DEFECTIVE OR NONPERFORMING PRODUCT IS THE SOLE REMEDY OF THE CUSTOMER UNDER THIS LIMITED WARRANTY. EXCEPT AS EXPRESSLY PROVIDED HEREIN, COVIDIEN DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

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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. Customer acknowledges and hereby accepts that the Product contains certain software licensed from third parties, including open source software (collectively, “Third Party Software”) that may be subject to additional or different license terms. The evaluation allowance herein and any ultimate price paid by Customer for the Products incorporating the Software include as a portion of that evaluation allowance, or price, a license fee granting Customer only the rights set forth in this Software License. Customer further acknowledges and agrees that the Software is owned exclusively by COVIDIEN. The Software is licensed to be used on only one computing device or Product, and a valid license must be purchased for each computing device on which the Software is installed. Single User License Grant: COVIDIEN grants to Customer a limited, nonexclusive, nonsublicensable, nontransferable and revocable license to use the Software, exclusively at Customer’s location as identified by Customer as the ship-to location of the Product, solely in machine-readable object code form only on a single central processing unit owned or leased by Customer or otherwise embedded in equipment provided by COVIDIEN, and for the sole purpose of Customer’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 Software License or by law, Customer shall not and shall not cause any third party to: (i) decompile, disassemble, or reverse engineer the Software; (ii) modify or create any derivative works (including, without limitation, translations, transformations, adaptations or other recast or altered versions) based on the Software, or alter the Software in any way; (iii) merge the Software with any other software or product not supplied by Supplier; (iv) use, copy, sell, sublicense, lease, rent, loan, assign, convey or otherwise transfer the Software except as expressly authorized by the Agreement; (v) distribute, disclose or allow use of the Software, in any format, through any timesharing service, service bureau, network or by any other means, to or by any third parties; (vi) remove or modify any copyright, confidential and/or proprietary markings, legends or restriction which are in the Software originally supplied to Customer; or (vii) violate any obligations with regard to COVIDIEN’s Confidential Information. To the extent that Customer is expressly permitted by applicable mandatory law to undertake any of the activities listed in the preceding sentence, Customer will not exercise those rights until Customer has given COVIDIEN thirty (30) days written notice of Customer’s intent to exercise any such rights unless an order of a government agency of competent jurisdiction will not so allow. Except for the limited license rights expressly granted in this Software License, COVIDIEN reserves all rights in and to the Software and any modifications thereto and derivations thereof, including, but not limited to, all title, ownership, intellectual property rights and all other rights and interests. Customer will own only the hardware or physical media on which the Software is stored or processed, if any.

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ClosureRFG Radiofrequency Generator

Software License

Customer agrees that the Software, including the specific design and structure of individual programs, constitute confidential information and trade secrets of COVIDIEN, whether or not the programs may be copyrighted or copyrightable, and/or patented or patentable. Customer agrees not to disclose, provide, or otherwise make available such confidential information, trade secrets or copyrighted material in any form to any third party. Customer agrees that it will make the Software available only to employees, contractors, or consultants with a need to know, who are obligated to comply with all license restrictions contained in this Software License Agreement and to maintain the secrecy of the Software and all other Confidential Information. Customer is responsible for the compliance of all users with these obligations. Customer may, from time to time, request that COVIDIEN incorporate certain features, enhancements or modifications into the 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. This Software License is effective until terminated. Customer may terminate this License at any time by destroying all copies of Software including any documentation. This License will terminate immediately upon notice from COVIDIEN if Customer fails to comply with any provision of this License or any supplier agreement. COVIDIEN may terminate the Software licenses granted herein and exercise all available rights by giving written notice, effective immediately, if within ten (10) business days of Customer’s receipt of a reasonably detailed written request to cure, Customer 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 delete, at COVIDIEN’s request, all copies of the Software in Customer’s possession, and certify compliance with all of the obligations herein to COVIDIEN in writing. Limited Warranty: COVIDIEN represents and warrants to Customer that the Software will perform substantially as described in COVIDIEN's then current documentation for such Software for the longer of (a) the remaining warranty applicable to the Product with which such Software was delivered (not to exceed one year) or (b) ninety (90) days from the date such Software was shipped or first made available to Customer for electronic download from COVIDIEN’s service site. If you notify COVIDIEN of defects during the warranty period, COVIDIEN will replace the Software or, at its option, refund the purchase price. Your remedy for breach of this limited warranty shall be limited to replacement or refund and shall not encompass any other damages. No dealer, distributor, agent or employee of COVIDIEN is authorized to make any modification or addition to the warranty and remedies stated above. Notwithstanding these warranty provisions, all of COVIDIEN's obligations with respect to such warranties shall be contingent on Customer’s use of the Software in accordance with this Agreement and in accordance with COVIDIEN's instructions as provided by COVIDIEN in the documentation, as such instructions may be amended, supplemented, or modified by COVIDIEN from time to time. COVIDIEN shall have no warranty obligations with respect to any failures of the Software which are the result of accident, abuse, misapplication, extreme power surge or extreme electromagnetic field. This warranty does not apply to any damages, malfunctions, or non-conformities caused to or by: (i) Customer’s use of Software in violation of the license granted under the Agreement or in a manner inconsistent with any provided documentation; (ii) use of non-

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Software License

COVIDIEN furnished equipment, software, or facilities with its equipment or Products; (iii) Customer’s failure to follow COVIDIEN’s installation, operation, repair or maintenance instructions; (iv) Customer’s failure to permit COVIDIEN timely access, remote or otherwise, to Products; (v) failure to implement all new Updates to Software provided under the 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. DISCLAIMER: EXCEPT AS SPECIFIED IN THIS WARRANTY, ALL EXPRESS OR IMPLIED CONDITIONS, REPRESENTATIONS, AND WARRANTIES INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICE, ARE HEREBY EXCLUDED TO THE EXTENT ALLOWED BY APPLICABLE LAW. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY LOST REVENUE, PROFIT, OR DATA, OR FOR SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE DAMAGES HOWEVER CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY ARISING OUT OF THIS SOFTWARE LICENSE EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT SHALL ONE PARTY’S LIABILITY TO THE OTHER PARTY, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE PRICE PAID OR TO HAVE BEEN PAID BY CUSTOMER. THE FOREGOING LIMITATIONS SHALL 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 Software is a “commercial item” developed exclusively at private expense, consisting of “commercial computer software” and “commercial computer software documentation” as such terms are defined or used in the applicable U.S. acquisition regulations. The Software is licensed hereunder (i) only as a commercial item and (ii) with only those rights as are granted to all other customers pursuant to the terms and conditions of this License. Customer shall not use, duplicate, or disclose the Software in any way not specifically permitted by this License. Nothing in this License requires COVIDIEN to produce or furnish technical data for or to Customer. If any provision of this Agreement shall be held by a court of competent jurisdiction to be illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect. This License Agreement contains the entire understanding and agreement between the parties respecting the Software. This Agreement may not be supplemented, modified, amended, released or discharged except by an instrument in writing signed by each party's duly authorized representative. All captions and headings in this Agreement are for purposes of convenience only and shall not affect the construction or interpretation of any of its provisions. Any waiver by either party of any default or breach hereunder shall not constitute a waiver of any provision of this Agreement or of any subsequent default or breach of the same or a different kind. The construction and performance of this Agreement will be governed by the laws of the Commonwealth of Massachusetts without reference to its choice of law principles. The

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ClosureRFG Radiofrequency Generator

Software License

parties hereby submit to the jurisdiction of the courts of the Commonwealth of Massachusetts.

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Table of Contents Preface... ii Conventions Used in This Guide... ii Limited Warranty...iii Software License...iv

Chapter 1. Overview & General Features Overview... 1-1 Indications for Use... 1-1 Intended Use... 1-2 Equipment Type... 1-2 Supported Accessories and Equipment... 1-2 Visual Indicators... 1-3 Audible Indicators... 1-3 Front Panel... 1-4 Rear 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 Inspection of Components... 1-9

Chapter 2. ClosureRFG Generator Setup Installation Requirements... 2-1 Applying AC Power... 2-2 Standby Screen... 2-3 Setting System Language... 2-4 Setting System Date... 2-5 Setting System Time... 2-6 Adjusting Display Brightness... 2-7 Adjusting Sound... 2-7 Total Treatment Summary Readout... 2-8 Functional and Advisory Limits... 2-8 Connecting a Catheter... 2-9

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Chapter 3. Covidien ClosureFast Endovenous Radiofrequency Catheter Treatment Ready-to-Treat Screen... 3-1 ClosureFast Catheter Gauges... 3-2 ClosureFast Catheter RF Treatment – Ready to Treat... 3-3 Functional and Advisory Limits... 3-3 Starting RF Treatment... 3-4 Stopping RF Treatment... 3-6

Chapter 4. Covidien ClosureRFS Endovenous Radiofrequency Stylet Treatment Ready-to-Treat Screen... 4-1 ClosureRFS Stylet Gauges... 4-2 ClosureRFS Stylet RF Treatment-Ready to Treat... 4-3 Functional and Advisory Limits... 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 Treatment Data Storage... 5-3 Using Memory Cards... 5-3 USB Devices... 5-3 SD Cards... 5-5

Chapter 6. Messages, Tones, and Responses Condition and System Responses... 6-1 Audible Signals... 6-5

Chapter 7. Error Codes Chapter 8. Troubleshooting Technical Assistance... 8-1 Generator Fails to Power On... 8-1 RF Treatment Difficulties... 8-1 Error Codes-Generator... 8-5

Chapter 9. Technical Specifications Equipment Type... 9-1 Electrical: ClosureRFG Generator... 9-1 100-120 VAC, 5 A... 9-1 220-240 VAC, 5 A... 9-2 Conditions for Transporting and Storing the ClosureRFG

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ClosureRFG Radiofrequency Generator

Generator... 9-2 Conditions for Operating the ClosureRFG Generator... 9-2 RF Power Delivery Performance... 9-2 Maximum Output... 9-3 Duty Cycle... 9-3 System Overview... 9-4 Description of Sub-systems... 9-4 General Description and Operating Conditions... 9-6 Environmental Conditions... 9-7 Transportation and Storage... 9-7 Operation... 9-7 Common Symbols and Icons... 9-8 Power 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 Disinfecting... 10-3 Disposal... 10-4

Chapter 11. Electrical Safety Tests Electrical Safety Tests 220-240 V... 11-1 Electrical Safety Tests 110-120 V... 11-3 Electromagnetic Compliance (EMC)... 11-4 Electromagnetic Interference (EMI)... 11-8 Biomedical Department Inspection and Power Output Test. . 11-9 Set-up Procedure... 11-9 Test Method... 11-10 Power Delivery Verification... 11-10

Chapter 12. Glossary of Terms

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Chapter 1 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.

The ClosureRFG generator is a product of Covidien. It is designed to provide controlled delivery of radiofrequency (RF) energy to RF catheters marketed by Covidien. The ClosureRFG generator is for use with Covidien ClosureFast™ endovenous radiofrequency catheters and Covidien ClosureRFS™ endovenous radiofrequency stylets. Throughout this manual, the term “catheter” generally refers to both compatible ClosureFast catheters and ClosureRFS stylets that can be attached to the ClosureRFG generator. Important Please refer to the instructions for use included with the RF catheters for more information, such as clinical procedures, cautions, warnings, precautions, potential complications, and contraindications.

Additional technical details for the ClosureRFG generator are contained in Chapter 10, Service & Maintenance.

Indications for Use The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.

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Intended Use

Intended Use The ClosureRFG radiofrequency generator supplies, 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 temperature during RF delivery.

Equipment Type The Class I ClosureRFG generator is designed to work with Type CF, defibrillatorproof RF catheters. The ClosureRFG generator will withstand an application of an external defibrillator while the RF catheter is in use.

Supported Accessories and Equipment The ClosureRFG radiofrequency generator supports the following accessories •

Power cords 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 radiofrequency catheters with cord length of 8 ft.

–

Covidien ClosureFast 3 cm endovenous radiofrequency catheters with cord length of 8 ft.

Important The catheters listed above have a voltage rating that is higher than the maximum delivered by the ClosureRFG generator. Refer to the RF treatment catheter’s instructions for use for more information.

Caution Use of unapproved RF delivery catheters or accessories may result in unanticipated performance, patient/operator safety hazard and increased emissions or decreased immunity.

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•

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

Visual Indicators

The ClosureRFG radiofrequency generator includes the following visual indicators, not including the screen (see Front Panel on page 1-4) •

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

Overview & General Features

Visual Indicators

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. •

Alarm, medium priority: Three rapid, mid-frequency mixed tones

•

Informational: Single short, high-frequency pure tone

•

RFS Advisory: Two short informational tones

•

Power On: Three ascending-scale pure tones

•

RF Start: Single, long mid-frequency pure tone

•

RF Stop: Single, long mid-frequency pure tone (Same as RF Start)

•

RF Ramp up: Single, long, lower-volume mid-frequency pure tone

•

RF On: Two short mid-frequency tones, the first at a higher frequency than the second

•

Valid key entry or button pushed: Single short, high-frequency pure tone

•

Invalid entry: Single short, low-frequency raspy tone Important

Each button press produces a tone. If a button fails to sound, this indicates a button malfunction, and the ClosureRFG generator needs to be serviced.

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Front Panel

Front Panel

2

2

4

3

1 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.

ི Catheter Connector: Receptacle for the catheter. ཱི Touch Screen: Controls all functions of the ClosureRFG generator.

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ClosureRFG Radiofrequency Generator

Rear Panel

Overview & General Features

Rear Panel 2

3

ClosureRFS

4 1 5 6 The ClosureRFG radiofrequency generator rear panel includes these features:

཰ 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.

ི Top Handle: Best way to lift and carry the ClosureRFG generator. ཱི Fuse Holder: Includes two 5A/250V, 5x20 mm fuses. ུ AC Power Inlet: Connects the AC power cord to the ClosureRFG generator. ཱུ Equipotential Grounding Lug: Provides a point for an auxiliary earth ground or ESD wrist-strap connection.

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Side Panels

Side Panels 1

2

3 4 5

6

Right

Left

཰ Handles: The ClosureRFG radiofrequency generator has a handle on each side. Use these handles (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. ི USB Slot: Accepts a USB 2.0 device to export/store procedure data. ཱི SD Slot: Accepts an SD card. ུ Ethernet Service Port: Used for calibration 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 is highly dependent on factors under the operator’s control. There is no substitute for properly trained staff. It is important to read, understand, and follow these directions. The ClosureRFG radiofrequency generator is classified as an electrosurgical product. It must be operated in accordance with the guidelines in this section to ensure a safe environment and safe delivery of RF energy to the catheter. Failure to adhere to these guidelines might result in damage to the ClosureRFG generator and/or injury to the patient or user.

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ClosureRFG Radiofrequency Generator

General Safety Guidelines

The ClosureRFG generator contains no operator-serviceable parts. It must be returned to the factory for service.

Warnings and Safety Notices: Setting Up the ClosureRFG Generator

Overview & General Features

The ClosureRFG generator is for prescription use only. It is intended for use only by trained clinicians (operators) in a hospital or clinical environment.

Warning Electric Shock Hazard •

Do not use 3-to-2-prong grounding adapters.

•

Always use an AC power center-tap configuration for 240 V single phase circuit.

•

The ClosureRFG generator must only be connected to a supply mains with protective earth.

•

Do not remove the cover of the ClosureRFG generator.

Fire and Explosion Hazard •

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.

•

Do not place active instruments near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical instruments that are activated or hot from use can cause a fire. When not in use, place electrosurgical instruments in a safety holster or safely away from patients, the surgical team, and flammable materials.

•

Prevent pooling of flammable fluids and the accumulation of flammable or oxidizing gases or vapors under surgical drapes or near the surgical site. These fluids should be removed before use of electrosurgery.

•

Use of electrosurgery may create arcing or embers that pose a fire hazard, especially in oxygenenriched environments. Keep the device clean and free of all debris.

The ClosureRFG generator’s performance may be affected by the use of portable and mobile communications equipment operating in near proximity. Refer to Electromagnetic Interference (EMI) on page 11-8 for more information.

Caution Do not use the ClosureRFG radiofrequency generator if the AC power cord is damaged. Inspect the cord regularly for wear or damage. Damaged cords could result in patient or user injury. The ClosureRFG generator produces high voltages on the catheter. Inspect all cables regularly for wear or damage. Discontinue use and discard the cable if damaged. Damaged cables could result in patient or user injury from electric shock.

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General Safety Guidelines

Caution Protect the ClosureRFG generator from exposure to extreme moisture to avoid electric shock and damage to the equipment. To avoid unintentional burns, position the catheter away from the patient when the catheter is connected to the ClosureRFG generator but is not in use.

Important The ClosureRFG generator is for use without a Neutral Electrode connection. To allow generator heat to escape, verify that the ClosureRFG generator’s vent openings, located on the sides and back of the unit, are not obstructed. 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. Always refer to Covidien authorized personnel for service. The ClosureRFG generator must be connected to an appropriate power source. Mains power quality should be that of a typical commercial or hospital environment. If continued operation is required during power interruptions, the ClosureRFG generator must be powered from an uninterruptible power supply.

Warnings and Safety Notices: During RF Treatment Warning Use the ClosureRFG generator only with Covidien ClosureFast endovenous radiofrequency catheters or ClosureRFS endovenous radiofrequency stylets. DO NOT use catheters from any other manufacturer with the ClosureRFG generator as this may increase emissions, decrease immunity to interference, or injure the patient or user. Be alert for potential interference with pacemakers and other active implants. In case of doubt, approved qualified advice should be obtained. When the ClosureRFG generator is activated, the conducted and radiated electrical fields might interfere with other medical electrical equipment. Refer to Electromagnetic Interference (EMI) on page 11-8 for more information. To prevent patient injury, always check if the measured temperature, impedance (RFS stylets), and RF power shown in the data display area are within safe operating ranges. To avoid electric shock, while using the ClosureRFG radiofrequency generator, do not allow the patient to come into direct contact with grounded metal objects. To avoid electric shock, avoid contact of cords and cables with the patient, leads, or other equipment.

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General Safety Guidelines

Do not wrap the catheter cable around metal objects, as this might induce hazardous currents into the patient. The ClosureRFG generator requires special precautions regarding Electromagnetic Compliance and needs to be installed and put into service according to Electromagnetic Compliance (EMC) on page 11-4. ClosureRFG generator failure could result in an unintended increase in RF output.

Overview & General Features

Warning

Use of electrosurgery could result in neuromuscular stimulation resulting in patient injury. Electrodes and probes for monitoring, stimulating, and imaging devices can provide paths for highfrequency current even if battery powered, insulated, or isolated at line frequency. The risk of burns can be reduced, but not eliminated, by placing these electrodes or probes as far away from the ablation site as possible. Protective impedance (Ω) incorporated into the monitoring leads may further reduce the risk of burns and permit continuous monitoring during RF energy delivery, Do not use needles as monitoring electrodes during procedures.

Caution To prevent injury to the patient, do not start RF power until the catheter is properly positioned in the patient. RF power activation tones and lights are important safety features. Do not obstruct indicator lights or the screen. Do not disable auditory tones. The ClosureRFG generator should not be used adjacent to or stacked with other equipment. If adjacent use is necessary, the 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.

Unpacking and Inspection of Components Upon receiving the ClosureRFG radiofrequency generator, carefully unpack and inspect the items listed below: •

ClosureRFG generator without physical damage anywhere on the outside housing and screen

•

Approved hospital-grade AC power cord, without cracks, frays, or any visible cord or plug damage

•

CD-ROM, containing this operation manual

All damaged items must be repacked and returned to the Covidien Customer Service Department with prior approval. See Repairs and Returns on page 10-3 for contact information.

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