Barrx Flex RFA Energy Generator User Guide June 2013

User’s Guide

Barrx™ Flex RFA Energy Generator

Part Number 1062170 717-0046-01 (A)

Software License

Software License Covidien llc, (collectively called “COVIDIEN” herein) own the entire right, title, and interest in and to all of the computer programs and all portions thereof, and associated documentation (collectively, the “Software”) provided to Customer as may be installed in the Products and equipment addressed herein or provided separately, and it has the sole right to grant licenses hereunder. 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. 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

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Barrx Flex RFA Energy Generator User's Guide

Software License

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 nonCOVIDIEN 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

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Software License

numbers altered, defaced or deleted; (vii) Products or equipment that have been altered, serviced or modified by a party other than COVIDIEN; 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 State of Colorado without reference to its choice of law principles. The parties hereby submit to the jurisdiction of the courts of the State of Colorado.

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Barrx Flex RFA Energy Generator User's Guide

Service Life

Service Life The Barrx™ Flex RFA Energy Generator has a 5-year service life during which period Covidien will continue to provide applicable parts to service the unit. The serviceability of the Generator beyond the service life period is contingent on the availability of the replaceable parts.

Warranty Information Covidien warrants that, at the time of shipment, Covidien products (i) shall conform to their published specifications as Covidien may revise from time to time, and (ii) shall be free of defects in materials and workmanship, and (iii) shall be manufactured in accordance with GMP, and (iv) disposable product shall have no less than one (1) year remaining shelf life. This warranty shall apply for a single use with one patient: Covidien may, at its option, repair or replace any products which do not meet the preceding warranty, or refund the product purchase price. Warranty shall not apply to products or spare parts that have been modified or altered in any manner by anyone other than Covidien, or to defects caused (a) through no fault of Covidien during shipment to or from Buyer; (b) by the use or operation in an application or environment other than that intended or recommended by Covidien; (c) by service by anyone other than employees of, or persons approved in writing by Covidien; or (d) by accident, negligence, misuse, or other causes other than normal use. Replacement products and parts supplied under this warranty shall carry only the unexpired portion of the original warranty. The applicable warranty period for all products is one (1) year from date of shipment. The warranties set forth in this section are the exclusive warranties with respect to the products, and are given and accepted in lieu of any and all other warranties, guarantees, conditions and representations express or implied, concerning the merchantability, satisfactory quality or fitness for a particular purpose, or that the operation of the products will be uninterrupted or error free. Notwithstanding the foregoing, Covidien does not exclude liability to the extent that such liability may not be excluded or limited by law. In no event shall Covidien be liable for the cost of procurement of substitute products by the customer or for any special consequential or incidental damages. This limitation shall apply even if Covidien has been advised of the possibility of such damages, and notwithstanding any failure of essential purpose of any limited remedy provided herein. Extended Warranties are available. Please contact Covidien.

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Table of Contents Software License... 2 Service Life... 5 Warranty Information... 5

Chapter 1. Barrx™ Flex RFA Generator Introduction... 9 Indicated Use... 10 Contraindications... 10 Warnings and Precautions... 10 Energy Generator... 10 Ablation Catheters... 13 Sizing Balloons... 13 Precautions... 14 Energy Generator... 14 Ablation Catheters... 14 Sizing Balloon... 14 Installation... 15 Preparing the System for Use... 15 Mains Power Cord... 15 Energy Generator/ Accessory Cleaning and Disinfection Instructions... 15 Flex RFA Energy Generator Controls... 18 Energy Generator and Accessories... 22 Introduction... 22 Accessories... 22 Flex RFA Footswitch... 23 Flex RFA Output Cable... 24 Disposable Devices... 24 Set-up Procedure and Instructions for Use... 25 Connection of Accessories... 25 Power-Up... 26 Energy Generator Modes... 27 Troubleshooting... 35 Problem: No RF Power Output... 35 Operational and Fault Codes... 35 Technical Specifications... 48 RF Output... 48 Setting Limits... 48 Shutdown Limits... 49

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Measurement Accuracy... 49 Mechanical Specifications... 49 Electrical Safety... 49 Environmental Specifications... 50 Fuses and Line Voltage Ranges... 50 Footswitch Specifications... 50 Output Cable Specification... 50 Ablation Catheters... 50 Guidance and Manufacturer’s Declaration- Electromagnetic Compatibility... 51 Measurement Accuracy Graphs... 55 Labeling Symbols and User Information... 58

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Barrx Flex RFA Energy Generator User’s Guide

Introduction

Barrx™ Flex RFA Generator

Model 1190A-115A (Domestic) Model 1190A-230A (International)

Introduction The System presented in this User’s Guide consists of the Flex RFA Energy Generator with Barrx™ Flex RFA Output Cable, disposable single-use Barrx™ 360 RFA Balloon Catheter, Barrx™ 90 RFA Focal Catheter, Barrx™ Ultra Long RFA Focal Catheter, Barrx™ 60 RFA Focal Catheter, Barrx™ 360 Classic Sizing Balloon, or Barrx™ 360 Soft Sizing Balloon, and an optional accessory Barrx™ Flex RFA Footswitch. The Flex RFA Energy Generator supplies up to 300 watts of radio frequency (RF) power at 460 kHz in a bipolar mode under power control while continuously monitoring and displaying power, energy density, and balloon inflation pressure. Energy density is displayed to allow equivalent energy delivery to the range of 360 RFA Balloon Catheter diameters, the 90 RFA Focal Catheter, the Ultra Long RFA Focal Catheter, and 60 RFA Focal Catheter. An inflation system is also included in the Flex RFA Energy Generator. For the user’s convenience, the Flex System may be referred to in this User’s Guide as the “System,” the Flex RFA Energy Generator may be referred to as the “Energy Generator,” the Flex RFA Output Cable may be referred to as the “Output Cable,” the 360 RFA Balloon Catheters may be referred to as “Balloon Based Ablation Catheters,” the 90 RFA Focal Catheters, the Ultra Long RFA Focal Catheters, and the 60 RFA Focal Catheters may be referred to as “Non Balloon Based Ablation Catheter,” the 360 RFA Balloon Catheter, 90 RFA Focal Catheters, Ultra Long RFA Focal Catheter, and 60 RFA Focal Catheter may be referred to jointly as “Ablation Catheter,” the 360 Classic Sizing Balloon or 360 Soft Sizing Balloon may be referred to as the “Sizing Balloon,” the Ablation Catheters and Sizing Balloons may be referred to jointly as “Catheters” or “Disposable Devices” and the optional Flex RFA Footswitch may be referred to as the “Footswitch.” The Footswitch Unit houses two Foot Pedals, RF POWER ON/OFF (blue pedal) and AUTO INFLATION (gray pedal), and may be referred to as “Foot Pedal.” This User’s Guide provides a description of the Energy Generator, Output Cable, Disposable Devices, Footswitch, the Energy Generator’s controls and displays, and a sequence for its operation. This User’s Guide also supplies other information of importance to the user. This guide is intended as a User’s Guide only. Do not operate the System before thoroughly reading this guide or reading the IFU for the specific Ablation Catheter or Sizing Balloon being used.

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Indicated Use

Indicated Use The Flex RFA Energy Generator is indicated for use for the coagulation of soft tissue. The Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett’s Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia and Radiation Proctitis.

Contraindications This User’s Guide should be used in conjunction with the Instructions for Use provided with each type of disposable device. See Instructions for Use provided with the disposable device for the Contraindications.

Warnings and Precautions The safe and effective use of RF energy is highly dependent upon factors under the control of the operator. There is no substitute for a properly trained medical staff. It is important that the operating instructions supplied with the Energy Generator be read, understood and followed before use.

Energy Generator Warning Do not operate the Energy Generator before thoroughly reading this User’s Guide and the IFU for each disposable device. Do not remove the cover of the Energy Generator, as there is a potential for electrical shock. Refer to authorized personnel for service. Do not use the generator if significant damage to the cover or front panel is detected as there is a risk of electrical shock. Do not use this device in the presence of flammable anesthetics; other flammable gases, near flammable fluids such as skin prepping agents and tinctures, flammable objects, or with oxidizing agents. Observe appropriate fire precautions at all times. Do not use this device in oxygen enriched atmospheres, Nitrous Oxide (N2O) atmospheres, or in the presence of other oxidizing agents. While using this device during a procedure, the patient should not be allowed to come into direct contact with grounded metal objects such as the surgical table frame, the instrument table, etc.

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Barrx Flex RFA Energy Generator User's Guide

Indicated Use

Warning It is necessary to use the supplied hydrophobic filter (included in all Balloon Catheter’s packaging), placed between the pneumatic connector located at the proximal end of both the Sizing Balloon and Ablation Catheter and the pneumatic connector line on the Output Cable to ensure fluids are not aspirated into the Output Cable in the event of a balloon leak. If the catheter is used without the filter and a balloon leak occurs, inspect the clear tubing portion of the connecting Output Cable for traces of fluid. If fluid is detected, discontinue the use of the Output Cable and order a replacement. Only inflate all Barrx™ Balloon Catheters using the inflation system incorporated into the Energy Generator. If the Energy Generator displays an E95 or C56 Operational Code, this is most likely caused by an air leak in the system. If the E95 or C56 Operational Codes are observed, under endoscopic visualization, manually deflate the balloon using a syringe via pneumatic connector at the proximal end of Ablation Catheter, remove and replace the catheter. Visual endoscopic confirmation of complete balloon deflation must be performed prior to attempting to reposition or remove a Balloon Based Ablation Catheter or Sizing Balloon. Do not deliver RF energy in areas containing surgical staples. The presence of metallic staples may disturb the treatment pattern and may lead to complications. Needle monitoring electrodes are not recommended for use with this equipment. Patient monitoring systems used with this equipment should incorporate high frequency currentlimiting devices. The Output Cable should be placed as to avoid unnecessary contact with patient leads or leads from other patient-connected equipment. Do not use the Output Cable if the insulation is damaged to prevent the risk of electrical shock. Failure of the Energy Generator could result in an unintended power output increase. Place any monitoring electrodes as far as possible from the surgical electrodes when RF surgical equipment and physiological monitoring equipment are used simultaneously on the same patient. Electrosurgery should be used with caution in the presence of internal or external pacemakers. Interference produced with the use of electrosurgical devices can cause devices such as a pacemaker to enter an asynchronous mode or can block the pacemaker entirely. Consult the pacemaker manufacturer or hospital Cardiology Department for further information when use of electrosurgical devices are planned to be used in patients with cardiac pacemakers. This equipment is intended to be used by healthcare professionals only. This equipment has been tested and complies with the limits for medical devices to the IEC 606011-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

Barrx Flex RFA Energy Generator User's Guide

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Indicated Use

Warning EMC testing ensured the Energy Generator’s immunity to interference was sufficient to maintain accurate power output (+/- 20%) and prevent unintended activation of power output. Testing also ensured reasonable protection against disruption of nearby equipment from the Energy Generator’s conducted and radiated emissions. When the Energy Generator is activated, the conducted and radiated electrical fields may interfere with other electrical medical equipment. The Energy Generator must be installed and put into service according to the EMC information provided in Guidance and Manufacturer’s Declaration- Electromagnetic Compatibility. Portable and mobile RF communications equipment can affect the Energy Generator function. The Energy Generator should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Energy Generator should be observed to verify normal operation in the configuration in which it will be used. Use of the Energy Generator with accessories or cables other than those supplied and manufactured by Covidien may result in increased emissions or decreased immunity of the Energy Generator. This equipment may cause radio interferences or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the equipment or shielding the location. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: •

Reorient or relocate the receiving device.

•

Increase the separation between the equipment.

•

Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.

•

Consult the manufacturer or field service technician for help.

USB port connector on rear panel is for manufacturer’s use only, do not attempt to connect anything to this port. The AC power cord is the mains disconnect device. Allow sufficient spacing in rear of Generator to be able to disconnect the AC power cord. Generator contains a 3.3V Lithium Battery (Ref designator BTI) and a 5A 250V μ Fuse (Ref designator FI). These parts may only be replaced by Covidien authorized service personnel. There are no user-serviceable parts in this device. Refer servicing to qualified Covidien personnel. For service information, please call 888-662-2779 or 408-328-7310, or refer to the Covidien web site: www.barrx.com.

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Barrx Flex RFA Energy Generator User's Guide

Indicated Use

Ablation Catheters Warning See 360 RFA Balloon Catheter, 90 RFA Focal Catheter, Ultra Long RFA Focal Catheter, and 60 RFA Focal Catheter Instructions for Use (IFU). Do not use the 360 RFA Balloon Catheter, 90 RFA Focal Catheter, Ultra Long RFA Focal Catheter, or 60 RFA Focal Catheter if the catheter insulation is damaged, as there is a risk of electrical shock.

Sizing Balloons Warning See 360 RFA Balloon Catheter and Sizing Balloon IFU.

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Precautions

Precautions Energy Generator Precautions In order to avoid the potential of having to abort a patient procedure, specifically after the patient has undergone conscious sedation/anesthesia, the generator should be powered up and the front panel display should read, “Ready Connect Catheter”. After this message is indicated on the display the patient can be prepped including conscious sedation/anesthesia and the procedure can proceed. This System cannot be used at an elevation greater than 7000 feet (2134 meters) above sea level or lower than 300 feet (91 meters) below sea level. Do not activate the Energy Generator until the Ablation Catheter is properly positioned in the patient. The activation tone and light are important safety features. Do not obstruct the activation light. Do not disable the audible tone. Use only the provided Flex RFA Footswitch model with the Energy Generator. The main Power cord of the Energy Generator MUST be connected to a properly grounded receptacle. Extension cords and/or adapter plugs MUST NOT be used. Do not wrap the Output Cable around metal objects. Wrapping cables around metal objects may induce hazardous currents. Disconnect all cables after use.

Ablation Catheters Precautions See 360 RFA Balloon Catheter, 90 RFA Focal Catheter, Ultra Long Focal Catheter, and 60 RFA Focal Catheter Instructions for Use (IFU). Ablation Catheter electrodes must be kept away from patient and user when not in use.

Sizing Balloon Precautions See 360 RFA Balloon Catheter and Sizing Balloon Instructions for Use (IFU)

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Barrx Flex RFA Energy Generator User's Guide

Installation

Installation Inspect the Energy Generator and Output Cable for any signs of physical damage to the front and/or back panel, chassis, cover, the Output Cable or any insulation. If any physical damage is found, DO NOT USE THE UNIT. Contact Covidien at www.barrx.com for a replacement.Covidien must approve all returns.

Preparing the System for Use The Energy Generator may be placed on a mounting cart, or on any sturdy table or platform. It is recommended that carts have non-conductive wheels. Refer to hospital procedures or local codes for detailed information. Provide at least four to six inches of space around the sides and top of the Energy Generator for convection cooling. Do not prop the Energy Generator on top of anything that will interfere with its underside clearance. Do not store items directly under the Energy Generator. Do not stack Generators. Under continuous use for extended periods of time, it is normal for the top and rear panel to be warm.

Mains Power Cord The Energy Generator is shipped with an approved hospital grade mains power cord. Do not use extension cords or three-prong to two-prong adapters. The mains power cord assembly should be periodically checked for damaged insulation or connectors.

Energy Generator/Accessory Cleaning and Disinfection Instructions Neither the Energy Generator nor its accessories are sterilizable. Do not allow fluids to enter the Energy Generator chassis, Generator connectors, output cable connectors or the footswitch body or connector. The Energy Generator cover, rear panel, front panel and its accessories may be wiped down/ disinfected using alcohol wipes (70% IPA /30% DI Water) or sodium hypochlorite 500 ppm wipes. Do not expose the metal pins of the connector to the sodium hypochlorite wipes in order to prevent corrosion. Do not spray or pour liquids directly on the Generator or accessories.

Barrx Flex RFA Energy Generator User's Guide

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Installation

Figure 1A - Barrx™ Flex RFA Energy Generator Front View with Footswitch

Figure 1B - Barrx™ Flex RFA Energy Generator Rear View (1190A-115A)

Figure 1C - Barrx™ Flex RFA Energy Generator Rear View (1190A-230A)

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Barrx Flex RFA Energy Generator User's Guide

Installation

Figure 1D – Barrx™ Flex RFA Energy Generator Front View (1190A-115A & 1190A-230A)

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Installation

Flex RFA Energy Generator Controls A description of the control buttons and their functions are given below. Please refer to Figures 1A through 1D for the location of each item on the generator.

Energy Generator Buttons Graphic

Button Description Up Increases the value displayed in the adjacent numeric LED display. A single depression of the key increases the value by one unit. Continuous depression increases the display to the maximum allowable value. The Power output setting cannot be adjusted. Down Decreases the value displayed in the adjacent numeric LED display. A single depression of the key decreases the value by one unit. Continuous depression decreases the display to the minimum allowable value. The Power output setting cannot be adjusted. RF POWER CONTROL Starts and stops the output of radiofrequency energy. The switch flashes blue when the balloon is inflated and/or when energy is ready to be delivered. The switch is constantly illuminated with a blue lamp when RF energy is being delivered. The switch initiates RF energy delivery to Ablation Catheter electrodes. AUTOMATIC INFLATE OR DEFLATE CONTROL BUTTONS Allows inflation or deflation of Balloon Based Ablation Catheter and Sizing Balloons. (N/A for Non Balloon Based Ablation Catheters). Pressing of the Button once causes the balloon inflation system to inflate the Ablation Catheter or the Sizing Balloon to the MAXIMUM allowable pressure. Pressing of the Button causes the balloon inflation system to fully deflate the Ablation Catheter or Sizing Balloon. Note: 360 RFA Balloon Catheter automatically deflates after the delivery of RF energy is completed. RESET Button Clears operational codes and recoverable codes. Does not clear unrecoverable codes.

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Barrx Flex RFA Energy Generator User's Guide

Installation

Graphic

Button Description CALIBRATE Button Used to calibrate the Sizing Balloon. Calibration is performed on the Sizing Balloon to establish measurement accuracy.

Energy Generator Displays (Green Color LEDs) Graphic

Description POWER Display During CATHETER CONNECTED and RF POWER ON Modes, displays the catheter’s rated maximum RF power that can be applied.

ENERGY DENSITY Display Displays the maximum energy density that can be applied, as set by the Energy Generator. Energy density is calculated based on desired amount of energy divided by the area of Ablation Catheter electrode selected. Range: 1.0-99.9 J/cm2 BALLOON DIAMETER Display Indicates diameter of organ as measured by the Sizing Balloon. Range: 1 to 99.9 mm

BALLOON PRESSURE Display Indicates pressure level in the Automatic Inflation system. Negative pressure (i.e., a vacuum) is displayed as “LO”. Range: LO to + 9.99 atm SYSTEM STATUS Display The LCD display is used to display User instructions and Error and Operational Codes with messages. The system includes a 2 x 20 character alpha-numeric display. The viewing area of this display is approximately 0.73 inches high by 3.27 inches wide and has green characters on a black background.

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Installation

Energy Generator Indicators There are 4 colored LED’s to indicate the display and operational status of the Energy Generator. Graphic

Description SET Indicator A green LED will be illuminated when the values displayed on the front panel are the set values.

ARMED Indicator A yellow LED will be illuminated when the system is in the CATHETER CONNECTED Mode.

COMPLETED Indicator A green LED will be illuminated when the system has finished its energy delivery.

FAULT Indicator A red LED will be illuminated when the system has encountered a fault.

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Barrx Flex RFA Energy Generator User's Guide