Description

Introduction

The VNUS Radiofrequency Generator (RFGPLUS) is a product of VNUS Medical Technologies, Inc. It is designed to provide controlled delivery of radiofrequency (RF) energy to RF Devices (e.g., catheters) marketed by VNUS. The term “Device,” used throughout this manual, refers to compatible VNUS RF Devices that can be attached to the RF Generator.

Intended Use

The VNUS RF Generator model RFG2 is intended for use with radiofrequency devices intended for vessel and tissue coagulation. 

The RF Generator measures and displays RF output Power, load Impedance (ClosureRFS only), and elapsed time of RF delivery. The RF Generator also interfaces with a sensor in the Device to provide a continuous display of measured Temperature during RF delivery.

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 RF Generator is classified as an electrosurgical product. It must be operated in accordance with the safety guidelines described in this section to ensure a safe environment and safe delivery of RF energy to the patient or to the Device. Failure to adhere to these safety guidelines might result in damage to the RF Generator and/or injury to the patient.

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

The RF Generator contains no operator-serviceable parts. The RF Generator must be either returned to the factory or repaired by qualified service personnel.

Precautions/Operation Warnings and Cautions

Before operating the RF Generator, review and adhere to these guidelines:

• Do not use the RF Generator if the ACPower cords are damaged.  

• Inspectall cords and cables regularly for wear or damage. Discontinue Use And Discard If Damaged.  

• Do notuse3–to–2 prong grounding adapters.  

• Always Use An ACPower center-tap configuration for240V systems in the U.S.  

• Do not operate the RF Generator in contact with flammable materials, chemicals,or substances.  

• Protect the RF Generator from exposure to extreme moisture, such as rain.  

• Verify that the RF Generators Vent Opening, located at the bottom of the unit, is not obstructed. Covering the speaker opening might prevent the operator from detecting auditory tones.  

• Do not remove the cover of the RF Generator.There’s Potential for electrical shock.  

• Always refer to authorized personnel for service.  

• An RF Generator failure could result in an unwanted increase in RFPower.

WARNING: The RF Generator produces high voltages on the Device.

RF Treatment Warnings and Cautions

Before performing RF Treatment, review and adhere to these guidelines:

•  DANGER,EXPLOSION HAZARD: Do not use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide

• Use the VNUS RF Generator only with VNUSClosureFAST or ClosureRFS. DO NOT use with Devices from any other manufacturer with the RFG2 as this may increase the possibility of increased emissions or decreased immunity.

• Avoid contact of cords and cables with patients, leads,or other equipment.

• Do not wrap the Device Cable Around metal objects,as this might induce hazardous currents into the patient.

•  Be alert for potential interference with pacemakers and other active implants.

• To prevent patient injury,always check to determine if the measured Temperature, Impedance(not displayed for ClosureFAST), and RF Power shown in the Data Display area are within safe ranges.

• While using the RF Generator during a procedure,do not allow the patient to come into direct contact with grounded metal objects.

• When the RF Generator is activated, the conducted and radiated electrical fields might interfere with other medical electrical equipment. Refer to the “Electromagnetic Interference (EMI)” section of this manual for more information.

• Do not activate RFPower until the Device is properly positioned in the patient.

•  RFPower activation tones and lights are important safety features. Do not obstruct lights. Do not disable auditory tones.

Environmental Conditions

Transportation and Storage

During transportation and storage, adhere to these guidelines:

• Store the RF Generatorat temperatures between –20°C and 70°C and in non-condensing relative humidity ≤ 90%.

• Do not stack items on top of the RF Generator 

• When the RF Generator is not in use,unplug the unit from the ACPoweroutletand wrap the cord around the AC Power cord wrap area.

• Do not carry or lift the RF Generator by the ACPower cord.

• The chemicals from a broken LCD screen are toxic when ingested; handle with care,especially if the LCD screen is broken. If chemicals from a broken LCD screen are accidentally ingested, obtain medical attention immediately.

Operation

Conditions for operating the RF Generator include the following:

• Temperature between 10ºC and 40ºC

• Relative humidity(non-condensing) between 0% and 90%

Caution: After removing the RF Generator from a storage environment, allow the unit to fully acclimate to the new environment before turning on the unit. Operate the RF Generator only at temperatures between 10°C and 40°C. Operate the RF Generator only in non-condensing humidity conditions.

Unpacking and Inspection of Components

Upon receiving the RF Generator, carefully unpack and inspect the items listed below:

•  RF Generator without physical damage to the front or back panels, cover,or screen

• Approved hospital-grade ACPower cord without cracks, frays, or any visible cord or plug damage

• CD-ROM containing this Operator’s Manual and the Service Manual

All damaged items must be repacked and returned to VNUS Customer Service Department with prior approval. See the back of this manual for contact information.

Setup and Installation

The RF Generator must be installed and put into service according to the guidance provided in this document to ensure its electromagnetic compatibility. If in doubt, consult VNUS Customer Service or a local distributor.

The RF Generator should be used only with a Hospital Grade power cord and plugged into only grounded, Hospital Grade ACsources.

The VNUS RF Generator can be placed on any stable cart, table, or platform. It is recommended that the cart have conductive wheels and be rated to hold at least 11.5 kg (25 lbs.). Refer to facility protocols and local ordinances for more information. 

Provide at least 10 to 15 cm (4–6 in.) of space around the sides and top of the RF Generator for air circulation and cooling. After continuous use for extended periods of time, it is normal for the top and rear panel to be warm. Do not block vent openings.

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

Mechanical Specifications

•  Size: 38cm x 38cm x 19cm (15in. x15in. x7.5in.) maximum

• Weight: 9kg (20lbs.) maximum

Instructions for Use

To ensure safe RF delivery, it is important to be familiar with how the RF Generator works, how to change desired settings, and how to interpret displays

AC Power

The VNUS RF Generator includes an approved hospital-grade AC Power cord.

Prior to each use, inspect the AC Power cord, the AC Power inlet, and the AC Power outlet that the unit plugs into.

1. Plug the AC Power cord into the AC Power inlet at the back of the unit. 

2. Plug the AC Power cord into a grounded hospital-grade AC Power outlet. 

3. Press the AC Power switch UP to turn on the unit. 

4. Verify the AC Power indicator is lit when the unit turns on. If the indicator is not lit, check the AC Power cord, fuses, and AC Power outlet.  

5.Verify all pixels on the unit’s LCD screen illuminate white when turning on theunit.To turn on the RF Generator:

Caution: Do not plug the RF Generator into the AC Power outlet if any of its surfaces appear to be cracked or damaged. Do not use the RF Generator if the AC Power cord is damaged. Do not use extension cords and/or adapter plugs

Changing Settings

The RF Generator lets the operator change the values of Device and RF Generator settings. The operator should be familiar with how to change setting values:

1. Use the Soft Key Menu buttons located below the Data Display area to choose the DEVICE SETUP or RFG SETUP Soft Key Menu.

The Operator Message area displays a sub-menu of settings.  

TheSoft Key Menu area displays relatedSoft Key Menus:

 • DEFAULTS: Returns all settings to the RF Generator’s factory defaults (except for Date,Time,and Language settings).

•SELECT: Indicates the options for the highlighted setting

•EXIT: Returns to the previous screen.

2. Use the Increment/UP and Decrement/DOWN buttons to highlight a setting.

3. Press the SELECTSoft Key Menu button to select the highlighted setting. The Operator Message area indicates the value(s) for the highlighted setting.

The Soft Key Menu area displays relatedSoft Key Menus:

•DEFAULT: Restores the selected setting to the factory default value(except for Date,Time,and Language settings).

•ACCEPT: Saves the setting’s value(s) as the default value(s).

•CANCEL: Cancels the selection and returns to the previous screen.

4. Use the Increment/UP and Decrement/DOWN buttons to increment, decrement, or toggle the value(s) of the selected setting.

5. Press the ACCEPTSoft Key Menu button to save the choice as a default setting or press theCANCEL Soft Key Menu button to return to the previous screen without saving any changes.

6. After changing the desired setting(s), press the EXITSoft Key Menu button to return to the RF Generator screen.